PRODUCTID PRODUCTNDC PRODUCTTYPENAME PROPRIETARYNAME PROPRIETARYNAMESUFFIX NONPROPRIETARYNAME DOSAGEFORMNAME ROUTENAME STARTMARKETINGDATE ENDMARKETINGDATE MARKETINGCATEGORYNAME APPLICATIONNUMBER LABELERNAME SUBSTANCENAME ACTIVE_NUMERATOR_STRENGTH ACTIVE_INGRED_UNIT PHARM_CLASSES DEASCHEDULE NDC_EXCLUDE_FLAG LISTING_RECORD_CERTIFIED_THROUGH 0002-1200_4bd46cbe-cdc1-4329-a8e7-22816bd7fc33 0002-1200 HUMAN PRESCRIPTION DRUG Amyvid Florbetapir F 18 INJECTION, SOLUTION INTRAVENOUS 20120601 NDA NDA202008 Eli Lilly and Company FLORBETAPIR F-18 51 mCi/mL Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA] N 20181231 0002-1407_14757f9d-f641-4836-acf3-229265588d1d 0002-1407 HUMAN PRESCRIPTION DRUG Quinidine Gluconate Quinidine Gluconate SOLUTION INTRAVENOUS 19500712 NDA NDA007529 Eli Lilly and Company QUINIDINE GLUCONATE 80 mg/mL Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0002-1433_b39d3d3d-6b7c-40c2-becb-953830f47f3f 0002-1433 HUMAN PRESCRIPTION DRUG Trulicity Dulaglutide INJECTION, SOLUTION SUBCUTANEOUS 20141107 BLA BLA125469 Eli Lilly and Company DULAGLUTIDE .75 mg/.5mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20181231 0002-1434_b39d3d3d-6b7c-40c2-becb-953830f47f3f 0002-1434 HUMAN PRESCRIPTION DRUG Trulicity Dulaglutide INJECTION, SOLUTION SUBCUTANEOUS 20141107 BLA BLA125469 Eli Lilly and Company DULAGLUTIDE 1.5 mg/.5mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20181231 0002-1445_609e2872-3087-49bc-8cc6-6f475b2a8fa9 0002-1445 HUMAN PRESCRIPTION DRUG TALTZ ixekizumab INJECTION, SOLUTION SUBCUTANEOUS 20160322 BLA BLA125521 Eli Lilly and Company IXEKIZUMAB 80 mg/mL Interleukin-17A Antagonist [EPC],Interleukin-17A Antagonists [MoA] N 20181231 0002-1975_23295988-5c83-40af-99e3-67ac0b5a9562 0002-1975 HUMAN PRESCRIPTION DRUG AXIRON testosterone SOLUTION TOPICAL 20101123 NDA NDA022504 Eli Lilly and Company TESTOSTERONE 30 mg/1.5mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0002-1977_23295988-5c83-40af-99e3-67ac0b5a9562 0002-1977 HUMAN PRESCRIPTION DRUG AXIRON testosterone SOLUTION TOPICAL 20101123 NDA NDA022504 Eli Lilly and Company TESTOSTERONE 30 mg/1.5mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0002-3004_f1404e9d-0c95-44e4-9eb0-7a2836a67bd8 0002-3004 HUMAN PRESCRIPTION DRUG Prozac Weekly Fluoxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20010316 NDA NDA021235 Eli Lilly and Company FLUOXETINE HYDROCHLORIDE 90 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0002-3227_324a23e9-1d68-42ba-8643-85cb35d45e5d 0002-3227 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20021126 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0002-3228_324a23e9-1d68-42ba-8643-85cb35d45e5d 0002-3228 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20021126 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0002-3229_324a23e9-1d68-42ba-8643-85cb35d45e5d 0002-3229 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20021126 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0002-3230_8b100d39-dee9-4cf8-aa57-9f4a661ffc38 0002-3230 HUMAN PRESCRIPTION DRUG Symbyax Olanzapine and Fluoxetine hydrochloride CAPSULE ORAL 20070409 NDA NDA021520 Eli Lilly and Company OLANZAPINE; FLUOXETINE HYDROCHLORIDE 3; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0002-3231_8b100d39-dee9-4cf8-aa57-9f4a661ffc38 0002-3231 HUMAN PRESCRIPTION DRUG Symbyax Olanzapine and Fluoxetine hydrochloride CAPSULE ORAL 20031224 NDA NDA021520 Eli Lilly and Company OLANZAPINE; FLUOXETINE HYDROCHLORIDE 6; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0002-3232_8b100d39-dee9-4cf8-aa57-9f4a661ffc38 0002-3232 HUMAN PRESCRIPTION DRUG Symbyax Olanzapine and Fluoxetine hydrochloride CAPSULE ORAL 20031224 NDA NDA021520 Eli Lilly and Company OLANZAPINE; FLUOXETINE HYDROCHLORIDE 12; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0002-3233_8b100d39-dee9-4cf8-aa57-9f4a661ffc38 0002-3233 HUMAN PRESCRIPTION DRUG Symbyax Olanzapine and Fluoxetine hydrochloride CAPSULE ORAL 20031224 NDA NDA021520 Eli Lilly and Company OLANZAPINE; FLUOXETINE HYDROCHLORIDE 6; 50 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0002-3234_8b100d39-dee9-4cf8-aa57-9f4a661ffc38 0002-3234 HUMAN PRESCRIPTION DRUG Symbyax Olanzapine and Fluoxetine hydrochloride CAPSULE ORAL 20031224 NDA NDA021520 Eli Lilly and Company OLANZAPINE; FLUOXETINE HYDROCHLORIDE 12; 50 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0002-3235_48f72160-f6f7-4890-8471-041da7cdd3a7 0002-3235 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Eli Lilly and Company DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0002-3238_324a23e9-1d68-42ba-8643-85cb35d45e5d 0002-3238 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20021126 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0002-3239_324a23e9-1d68-42ba-8643-85cb35d45e5d 0002-3239 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20021126 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0002-3240_48f72160-f6f7-4890-8471-041da7cdd3a7 0002-3240 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Eli Lilly and Company DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0002-3250_324a23e9-1d68-42ba-8643-85cb35d45e5d 0002-3250 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20050214 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0002-3251_324a23e9-1d68-42ba-8643-85cb35d45e5d 0002-3251 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20050214 NDA NDA021411 Eli Lilly and Company ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0002-3270_48f72160-f6f7-4890-8471-041da7cdd3a7 0002-3270 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 Eli Lilly and Company DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0002-4112_cd0ef401-5aed-4406-a26a-ab4c377409fe 0002-4112 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19970623 NDA NDA020592 Eli Lilly and Company OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20191231 0002-4115_cd0ef401-5aed-4406-a26a-ab4c377409fe 0002-4115 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Eli Lilly and Company OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20191231 0002-4116_cd0ef401-5aed-4406-a26a-ab4c377409fe 0002-4116 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Eli Lilly and Company OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20191231 0002-4117_cd0ef401-5aed-4406-a26a-ab4c377409fe 0002-4117 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Eli Lilly and Company OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20191231 0002-4165_ebd21fa8-ece9-403e-af48-62fecdb008bb 0002-4165 HUMAN PRESCRIPTION DRUG Evista Raloxifene hydrochloride TABLET ORAL 19980106 NDA NDA020815 Eli Lilly and Company RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0002-4184_ebd21fa8-ece9-403e-af48-62fecdb008bb 0002-4184 HUMAN PRESCRIPTION DRUG Evista Raloxifene hydrochloride TABLET ORAL 19980106 NDA NDA020815 Eli Lilly and Company RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0002-4415_cd0ef401-5aed-4406-a26a-ab4c377409fe 0002-4415 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20000110 NDA NDA020592 Eli Lilly and Company OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20191231 0002-4420_cd0ef401-5aed-4406-a26a-ab4c377409fe 0002-4420 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20010301 NDA NDA020592 Eli Lilly and Company OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20191231 0002-4453_cd0ef401-5aed-4406-a26a-ab4c377409fe 0002-4453 HUMAN PRESCRIPTION DRUG ZYPREXA Zydis Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20000601 NDA NDA021086 Eli Lilly and Company OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20191231 0002-4454_cd0ef401-5aed-4406-a26a-ab4c377409fe 0002-4454 HUMAN PRESCRIPTION DRUG ZYPREXA Zydis Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20000601 NDA NDA021086 Eli Lilly and Company OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20191231 0002-4455_cd0ef401-5aed-4406-a26a-ab4c377409fe 0002-4455 HUMAN PRESCRIPTION DRUG ZYPREXA Zydis Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20010901 NDA NDA021086 Eli Lilly and Company OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20191231 0002-4456_cd0ef401-5aed-4406-a26a-ab4c377409fe 0002-4456 HUMAN PRESCRIPTION DRUG ZYPREXA Zydis Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20010901 NDA NDA021086 Eli Lilly and Company OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20191231 0002-4462_a300bb97-176e-4771-8b31-3246d3f773f8 0002-4462 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Eli Lilly and Company TADALAFIL 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0002-4463_a300bb97-176e-4771-8b31-3246d3f773f8 0002-4463 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Eli Lilly and Company TADALAFIL 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0002-4464_a300bb97-176e-4771-8b31-3246d3f773f8 0002-4464 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Eli Lilly and Company TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0002-4465_a300bb97-176e-4771-8b31-3246d3f773f8 0002-4465 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20080107 NDA NDA021368 Eli Lilly and Company TADALAFIL 2.5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0002-4483_8c4f9290-9ff3-459a-bd13-6a9666d5fc6a 0002-4483 HUMAN PRESCRIPTION DRUG Verzenio abemaciclib TABLET ORAL 20170928 NDA NDA208716 Eli Lilly and Company ABEMACICLIB 50 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA] N 20181231 0002-4815_8c4f9290-9ff3-459a-bd13-6a9666d5fc6a 0002-4815 HUMAN PRESCRIPTION DRUG Verzenio abemaciclib TABLET ORAL 20170928 NDA NDA208716 Eli Lilly and Company ABEMACICLIB 100 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA] N 20181231 0002-5121_dec2c4de-adab-42c6-a981-015a1a9be91b 0002-5121 HUMAN PRESCRIPTION DRUG Effient Prasugrel hydrochloride TABLET, FILM COATED ORAL 20090710 NDA NDA022307 Eli Lilly and Company PRASUGREL HYDROCHLORIDE 5 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 0002-5123_dec2c4de-adab-42c6-a981-015a1a9be91b 0002-5123 HUMAN PRESCRIPTION DRUG Effient Prasugrel hydrochloride TABLET, FILM COATED ORAL 20090710 NDA NDA022307 Eli Lilly and Company PRASUGREL HYDROCHLORIDE 10 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 0002-5337_8c4f9290-9ff3-459a-bd13-6a9666d5fc6a 0002-5337 HUMAN PRESCRIPTION DRUG Verzenio abemaciclib TABLET ORAL 20170928 NDA NDA208716 Eli Lilly and Company ABEMACICLIB 150 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA] N 20181231 0002-5800_324a23e9-1d68-42ba-8643-85cb35d45e5d 0002-5800 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride KIT ORAL 20140831 NDA NDA021411 Eli Lilly and Company N 20181231 0002-5801_324a23e9-1d68-42ba-8643-85cb35d45e5d 0002-5801 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride KIT ORAL 20140831 NDA NDA021411 Eli Lilly and Company N 20181231 0002-5802_324a23e9-1d68-42ba-8643-85cb35d45e5d 0002-5802 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride KIT ORAL 20140831 NDA NDA021411 Eli Lilly and Company N 20181231 0002-6216_8c4f9290-9ff3-459a-bd13-6a9666d5fc6a 0002-6216 HUMAN PRESCRIPTION DRUG Verzenio abemaciclib TABLET ORAL 20170928 NDA NDA208716 Eli Lilly and Company ABEMACICLIB 200 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA] N 20181231 0002-7140_4444dd96-94e1-4842-834b-773115c221b4 0002-7140 HUMAN PRESCRIPTION DRUG REOPRO abciximab INJECTION, SOLUTION INTRAVENOUS 19931216 20190131 BLA BLA103575 Eli Lilly and Company ABCIXIMAB 2 mg/mL N 20181231 0002-7190_d99e4d3e-76c9-4504-ac29-c62e1e96ce3a 0002-7190 HUMAN PRESCRIPTION DRUG LARTRUVO olaratumab INJECTION, SOLUTION INTRAVENOUS 20161019 BLA BLA761038 Eli Lilly and Company OLARATUMAB 10 mg/mL N 20181231 0002-7335_b74c9b2a-013f-41ca-8768-f70811b26eb0 0002-7335 HUMAN PRESCRIPTION DRUG HUMATROPE Somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 19870401 NDA NDA019640 Eli Lilly and Company N 20181231 0002-7501_ca20741b-2f42-40f2-90a7-7cb9e4ed22e0 0002-7501 HUMAN PRESCRIPTION DRUG Gemzar Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960515 NDA NDA020509 Eli Lilly and Company GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0002-7502_ca20741b-2f42-40f2-90a7-7cb9e4ed22e0 0002-7502 HUMAN PRESCRIPTION DRUG Gemzar Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960515 NDA NDA020509 Eli Lilly and Company GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0002-7510_62aac1b3-3ff6-4419-9396-2e14e59e6ca4 0002-7510 HUMAN PRESCRIPTION DRUG Humalog Insulin lispro INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19960614 NDA NDA020563 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0002-7511_ddb5903e-0eb4-4147-8a1b-afdae83f155f 0002-7511 HUMAN PRESCRIPTION DRUG Humalog Mix75/25 Insulin lispro INJECTION, SUSPENSION SUBCUTANEOUS 19991222 NDA NDA021017 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0002-7512_cb0a27a8-3369-4092-8cf4-195c79bd7968 0002-7512 HUMAN PRESCRIPTION DRUG Humalog Mix50/50 Insulin lispro INJECTION, SUSPENSION SUBCUTANEOUS 19991222 NDA NDA021018 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0002-7516_62aac1b3-3ff6-4419-9396-2e14e59e6ca4 0002-7516 HUMAN PRESCRIPTION DRUG Humalog Insulin lispro INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19980220 NDA NDA020563 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0002-7597_cd0ef401-5aed-4406-a26a-ab4c377409fe 0002-7597 HUMAN PRESCRIPTION DRUG ZYPREXA Intramuscular Olanzapine INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20040401 NDA NDA021253 Eli Lilly and Company OLANZAPINE 10 mg/2mL Atypical Antipsychotic [EPC] N 20191231 0002-7623_198e5697-bfc8-451c-91fa-e75723963230 0002-7623 HUMAN PRESCRIPTION DRUG Alimta Pemetrexed disodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20040204 NDA NDA021462 Eli Lilly and Company PEMETREXED DISODIUM HEPTAHYDRATE 500 mg/20mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 0002-7635_fb254f6b-f7ca-4730-9080-58e077f8cffc 0002-7635 HUMAN PRESCRIPTION DRUG ZYPREXA Relprevv Olanzapine pamoate KIT INTRAMUSCULAR 20091211 NDA NDA022173 Eli Lilly and Company N 20191231 0002-7636_fb254f6b-f7ca-4730-9080-58e077f8cffc 0002-7636 HUMAN PRESCRIPTION DRUG ZYPREXA Relprevv Olanzapine pamoate KIT INTRAMUSCULAR 20091211 NDA NDA022173 Eli Lilly and Company N 20191231 0002-7637_fb254f6b-f7ca-4730-9080-58e077f8cffc 0002-7637 HUMAN PRESCRIPTION DRUG ZYPREXA Relprevv Olanzapine pamoate KIT INTRAMUSCULAR 20091211 NDA NDA022173 Eli Lilly and Company N 20191231 0002-7640_198e5697-bfc8-451c-91fa-e75723963230 0002-7640 HUMAN PRESCRIPTION DRUG Alimta Pemetrexed disodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20070907 NDA NDA021462 Eli Lilly and Company PEMETREXED DISODIUM HEPTAHYDRATE 100 mg/4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 0002-7669_82b47bfc-57e1-4299-a915-7a3003992b4b 0002-7669 HUMAN PRESCRIPTION DRUG CYRAMZA ramucirumab SOLUTION INTRAVENOUS 20140421 BLA BLA125477 Eli Lilly and Company RAMUCIRUMAB 10 mg/mL Vascular Endothelial Growth Factor Receptor 2 Antagonist [EPC],VEGFR2 Inhibitors [MoA] N 20181231 0002-7678_82b47bfc-57e1-4299-a915-7a3003992b4b 0002-7678 HUMAN PRESCRIPTION DRUG CYRAMZA ramucirumab SOLUTION INTRAVENOUS 20140421 BLA BLA125477 Eli Lilly and Company RAMUCIRUMAB 10 mg/mL Vascular Endothelial Growth Factor Receptor 2 Antagonist [EPC],VEGFR2 Inhibitors [MoA] N 20181231 0002-7712_62aac1b3-3ff6-4419-9396-2e14e59e6ca4 0002-7712 HUMAN PRESCRIPTION DRUG Humalog KwikPen Insulin lispro INJECTION, SOLUTION SUBCUTANEOUS 20150526 NDA NDA205747 Eli Lilly and Company INSULIN LISPRO 200 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0002-7714_62aac1b3-3ff6-4419-9396-2e14e59e6ca4 0002-7714 HUMAN PRESCRIPTION DRUG Humalog Junior KwikPen Insulin lispro INJECTION, SOLUTION SUBCUTANEOUS 19960614 NDA NDA020563 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0002-7715_64292cf6-9e48-42e4-a555-7da35aef3cdb 0002-7715 HUMAN PRESCRIPTION DRUG BASAGLAR Insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20151216 NDA NDA205692 Eli Lilly and Company INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0002-7716_62de9272-71de-4b81-8ccf-ad7806f02081 0002-7716 HUMAN PRESCRIPTION DRUG Portrazza necitumumab SOLUTION INTRAVENOUS 20151124 BLA BLA125547 Eli Lilly and Company NECITUMUMAB 16 mg/mL Epidermal Growth Factor Receptor Antagonist [EPC],HER1 Antagonists [MoA] N 20181231 0002-7724_609e2872-3087-49bc-8cc6-6f475b2a8fa9 0002-7724 HUMAN PRESCRIPTION DRUG TALTZ ixekizumab INJECTION, SOLUTION SUBCUTANEOUS 20160322 BLA BLA125521 Eli Lilly and Company IXEKIZUMAB 80 mg/mL Interleukin-17A Antagonist [EPC],Interleukin-17A Antagonists [MoA] N 20181231 0002-8031_b10b0567-a127-400f-a8a0-3bfe3c99b3ff 0002-8031 HUMAN PRESCRIPTION DRUG Glucagon glucagon KIT 19990301 NDA NDA020928 Eli Lilly and Company N 20181231 0002-8147_b74c9b2a-013f-41ca-8768-f70811b26eb0 0002-8147 HUMAN PRESCRIPTION DRUG HUMATROPE Somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 20060127 NDA NDA019640 Eli Lilly and Company N 20181231 0002-8148_b74c9b2a-013f-41ca-8768-f70811b26eb0 0002-8148 HUMAN PRESCRIPTION DRUG HUMATROPE Somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 20060127 NDA NDA019640 Eli Lilly and Company N 20181231 0002-8149_b74c9b2a-013f-41ca-8768-f70811b26eb0 0002-8149 HUMAN PRESCRIPTION DRUG HUMATROPE Somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 20060127 NDA NDA019640 Eli Lilly and Company N 20181231 0002-8215_464f0735-d48a-4d10-827c-02142a2f4928 0002-8215 HUMAN OTC DRUG Humulin R Insulin human INJECTION, SOLUTION PARENTERAL 19830627 NDA NDA018780 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL N 20181231 0002-8315_808ef0b4-f55a-4b04-840e-65e94fd328f8 0002-8315 HUMAN OTC DRUG Humulin N Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 19830627 NDA NDA018781 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL N 20181231 0002-8400_4d0a0023-d348-41dd-a689-43971e41d26f 0002-8400 HUMAN PRESCRIPTION DRUG Forteo Teriparatide INJECTION, SOLUTION SUBCUTANEOUS 20021126 NDA NDA021318 Eli Lilly and Company TERIPARATIDE 250 ug/mL Parathyroid Hormone [Chemical/Ingredient],Parathyroid Hormone Analog [EPC] N 20181231 0002-8501_26586365-93de-45c0-ae23-ab9430d0aaa3 0002-8501 HUMAN PRESCRIPTION DRUG Humulin R U-500 Insulin human INJECTION, SOLUTION SUBCUTANEOUS 19940331 NDA NDA018780 Eli Lilly and Company INSULIN HUMAN 500 [iU]/mL Insulin [Chemical/Ingredient],Insulin [EPC] N 20181231 0002-8715_aa460e03-9e43-4b00-83c5-7cb873e95927 0002-8715 HUMAN OTC DRUG Humulin 70/30 Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 19890626 NDA NDA019717 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL N 20181231 0002-8797_ddb5903e-0eb4-4147-8a1b-afdae83f155f 0002-8797 HUMAN PRESCRIPTION DRUG Humalog Mix75/25 KwikPen Insulin lispro INJECTION, SUSPENSION SUBCUTANEOUS 20070906 NDA NDA021017 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0002-8798_cb0a27a8-3369-4092-8cf4-195c79bd7968 0002-8798 HUMAN PRESCRIPTION DRUG Humalog Mix50/50 KwikPen Insulin lispro INJECTION, SUSPENSION SUBCUTANEOUS 20070906 NDA NDA021018 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0002-8799_62aac1b3-3ff6-4419-9396-2e14e59e6ca4 0002-8799 HUMAN PRESCRIPTION DRUG Humalog KwikPen Insulin lispro INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20070906 NDA NDA020563 Eli Lilly and Company INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0002-8803_aa460e03-9e43-4b00-83c5-7cb873e95927 0002-8803 HUMAN OTC DRUG Humulin 70/30 Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 20131107 NDA NDA019717 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL N 20181231 0002-8805_808ef0b4-f55a-4b04-840e-65e94fd328f8 0002-8805 HUMAN OTC DRUG Humulin N Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 20131107 NDA NDA018781 Eli Lilly and Company INSULIN HUMAN 100 [iU]/mL N 20181231 0002-8824_26586365-93de-45c0-ae23-ab9430d0aaa3 0002-8824 HUMAN PRESCRIPTION DRUG Humulin R U-500 KwikPen Insulin human INJECTION, SOLUTION SUBCUTANEOUS 20151229 NDA NDA018780 Eli Lilly and Company INSULIN HUMAN 500 [iU]/mL Insulin [Chemical/Ingredient],Insulin [EPC] N 20181231 0002-8926_d99e4d3e-76c9-4504-ac29-c62e1e96ce3a 0002-8926 HUMAN PRESCRIPTION DRUG LARTRUVO olaratumab INJECTION, SOLUTION INTRAVENOUS 20161019 BLA BLA761038 Eli Lilly and Company OLARATUMAB 10 mg/mL N 20181231 0003-0011_fdf4e994-23e3-4ee6-b9a9-33e3cc544c07 0003-0011 HUMAN PRESCRIPTION DRUG DAKLINZA daclatasvir TABLET ORAL 20160518 NDA NDA206843 E.R. Squibb & Sons, L.L.C. DACLATASVIR DIHYDROCHLORIDE 90 mg/1 Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 0003-0213_fdf4e994-23e3-4ee6-b9a9-33e3cc544c07 0003-0213 HUMAN PRESCRIPTION DRUG DAKLINZA daclatasvir TABLET ORAL 20150727 NDA NDA206843 E.R. Squibb & Sons, L.L.C. DACLATASVIR DIHYDROCHLORIDE 30 mg/1 Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 0003-0215_fdf4e994-23e3-4ee6-b9a9-33e3cc544c07 0003-0215 HUMAN PRESCRIPTION DRUG DAKLINZA daclatasvir TABLET ORAL 20150727 NDA NDA206843 E.R. Squibb & Sons, L.L.C. DACLATASVIR DIHYDROCHLORIDE 60 mg/1 Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 0003-0249_7d355981-e4d6-4d06-a2b3-eb83edce221b 0003-0249 HUMAN PRESCRIPTION DRUG HALOG Halcinonide SOLUTION TOPICAL 20090101 NDA NDA017823 E.R. Squibb & Sons, L.L.C. HALCINONIDE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0003-0293_e9f4b38f-d0d4-48a0-b358-ba78e4e08043 0003-0293 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20090601 NDA NDA014901 E.R. Squibb & Sons, L.L.C. TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0003-0371_3e6e910a-afb6-4c30-82b2-55e7339a4dba 0003-0371 HUMAN PRESCRIPTION DRUG NULOJIX BELATACEPT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110615 BLA BLA125288 E.R. Squibb & Sons, L.L.C. BELATACEPT 250 mg/1 T Lymphocyte Costimulation Activity Blockade [PE],Selective T Cell Costimulation Blocker [EPC],CD80-directed Antibody Interactions [MoA],CD86-directed Antibody Interactions [MoA] N 20181231 0003-0494_c6169b95-11a7-443f-afae-2236b31a9f5a 0003-0494 HUMAN PRESCRIPTION DRUG KENALOG-10 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL 20090601 NDA NDA012041 E.R. Squibb & Sons, L.L.C. TRIAMCINOLONE ACETONIDE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0003-0524_09609ce2-a06b-46ef-95b6-d4c256d9d14c 0003-0524 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20060627 NDA NDA021986 E.R. Squibb & Sons, L.L.C. DASATINIB 70 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 0003-0527_09609ce2-a06b-46ef-95b6-d4c256d9d14c 0003-0527 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20060627 NDA NDA021986 E.R. Squibb & Sons, L.L.C. DASATINIB 20 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 0003-0528_09609ce2-a06b-46ef-95b6-d4c256d9d14c 0003-0528 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20060627 NDA NDA021986 E.R. Squibb & Sons, L.L.C. DASATINIB 50 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 0003-0830_e28b7327-43f6-49d2-85c3-ac8ccf09430f 0003-0830 HUMAN PRESCRIPTION DRUG HYDREA HYDROXYUREA CAPSULE ORAL 20090601 NDA NDA016295 E.R. Squibb & Sons, L.L.C. HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] N 20181231 0003-0852_09609ce2-a06b-46ef-95b6-d4c256d9d14c 0003-0852 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20080530 NDA NDA021986 E.R. Squibb & Sons, L.L.C. DASATINIB 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 0003-0855_09609ce2-a06b-46ef-95b6-d4c256d9d14c 0003-0855 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20101028 NDA NDA021986 E.R. Squibb & Sons, L.L.C. DASATINIB 80 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 0003-0857_09609ce2-a06b-46ef-95b6-d4c256d9d14c 0003-0857 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20101028 NDA NDA021986 E.R. Squibb & Sons, L.L.C. DASATINIB 140 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 0003-0893_9e15c2cb-e038-4ba5-a252-1e6299d1c6e9 0003-0893 HUMAN PRESCRIPTION DRUG ELIQUIS apixaban TABLET, FILM COATED ORAL 20121228 NDA NDA202155 E.R. Squibb & Sons, L.L.C. APIXABAN 2.5 mg/1 Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 0003-0894_9e15c2cb-e038-4ba5-a252-1e6299d1c6e9 0003-0894 HUMAN PRESCRIPTION DRUG ELIQUIS apixaban TABLET, FILM COATED ORAL 20121228 NDA NDA202155 E.R. Squibb & Sons, L.L.C. APIXABAN 5 mg/1 Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 0003-1611_2cd9405d-3f37-4ec5-af91-4339d95d1f40 0003-1611 HUMAN PRESCRIPTION DRUG BARACLUDE entecavir TABLET, FILM COATED ORAL 20050329 NDA NDA021797 E.R. Squibb & Sons, L.L.C. ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0003-1612_2cd9405d-3f37-4ec5-af91-4339d95d1f40 0003-1612 HUMAN PRESCRIPTION DRUG BARACLUDE entecavir TABLET, FILM COATED ORAL 20050329 NDA NDA021797 E.R. Squibb & Sons, L.L.C. ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0003-1614_2cd9405d-3f37-4ec5-af91-4339d95d1f40 0003-1614 HUMAN PRESCRIPTION DRUG BARACLUDE entecavir SOLUTION ORAL 20050329 NDA NDA021798 E.R. Squibb & Sons, L.L.C. ENTECAVIR .05 mg/mL Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0003-1964_2b3b38f9-15c7-42f2-a050-20260ea4ba94 0003-1964 HUMAN PRESCRIPTION DRUG ZERIT Stavudine CAPSULE, GELATIN COATED ORAL 20170613 NDA NDA020412 E.R. Squibb & Sons, L.L.C. STAVUDINE 15 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0003-1965_2b3b38f9-15c7-42f2-a050-20260ea4ba94 0003-1965 HUMAN PRESCRIPTION DRUG ZERIT stavudine CAPSULE, GELATIN COATED ORAL 20170613 NDA NDA020412 E.R. Squibb & Sons, L.L.C. STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0003-1966_2b3b38f9-15c7-42f2-a050-20260ea4ba94 0003-1966 HUMAN PRESCRIPTION DRUG ZERIT stavudine CAPSULE, GELATIN COATED ORAL 20170613 NDA NDA020412 E.R. Squibb & Sons, L.L.C. STAVUDINE 30 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0003-1967_2b3b38f9-15c7-42f2-a050-20260ea4ba94 0003-1967 HUMAN PRESCRIPTION DRUG ZERIT stavudine CAPSULE, GELATIN COATED ORAL 20170613 NDA NDA020412 E.R. Squibb & Sons, L.L.C. STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0003-1968_2b3b38f9-15c7-42f2-a050-20260ea4ba94 0003-1968 HUMAN PRESCRIPTION DRUG ZERIT stavudine POWDER, FOR SOLUTION ORAL 20170613 NDA NDA020413 E.R. Squibb & Sons, L.L.C. STAVUDINE 1 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0003-2187_5ada8930-df4f-4371-9229-c66142f2c249 0003-2187 HUMAN PRESCRIPTION DRUG ORENCIA abatacept INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090101 BLA BLA125118 E.R. Squibb & Sons, L.L.C. ABATACEPT 250 mg/15mL Decreased Cytokine Activity [PE],Selective T Cell Costimulation Modulator [EPC],Recombinant Fusion Proteins [Chemical/Ingredient] N 20181231 0003-2188_5ada8930-df4f-4371-9229-c66142f2c249 0003-2188 HUMAN PRESCRIPTION DRUG ORENCIA abatacept INJECTION, SOLUTION SUBCUTANEOUS 20110729 BLA BLA125118 E.R. Squibb & Sons, L.L.C. ABATACEPT 125 mg/mL Decreased Cytokine Activity [PE],Selective T Cell Costimulation Modulator [EPC],Recombinant Fusion Proteins [Chemical/Ingredient] N 20181231 0003-2230_7d3fca83-3050-43ac-a343-0a32039361b4 0003-2230 HUMAN PRESCRIPTION DRUG AZACTAM AZTREONAM INJECTION, SOLUTION INTRAVENOUS 20100401 NDA NDA050632 E.R. Squibb & Sons, L.L.C. AZTREONAM 1 g/50mL Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] N 20191231 0003-2240_7d3fca83-3050-43ac-a343-0a32039361b4 0003-2240 HUMAN PRESCRIPTION DRUG AZACTAM AZTREONAM INJECTION, SOLUTION INTRAVENOUS 20100401 NDA NDA050632 E.R. Squibb & Sons, L.L.C. AZTREONAM 2 g/50mL Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] N 20191231 0003-2291_ae608a81-e5f5-4f26-a061-47820341156e 0003-2291 HUMAN PRESCRIPTION DRUG EMPLICITI elotuzumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20151130 BLA BLA761035 E.R. Squibb & Sons, L.L.C. ELOTUZUMAB 300 mg/1 SLAMF7-directed Immunostimulatory Antibody [EPC],SLAMF7-directed Antibody Interactions [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 0003-2327_60132616-5d0b-4fdd-a94f-9a8314a1aec2 0003-2327 HUMAN PRESCRIPTION DRUG YERVOY ipilimumab INJECTION INTRAVENOUS 20110325 BLA BLA125377 E.R. Squibb & Sons, L.L.C. IPILIMUMAB 5 mg/mL CTLA-4-directed Blocking Antibody [EPC],CTLA-4-directed Antibody Interactions [MoA],Increased T Lymphocyte Activation [PE] N 20181231 0003-2328_60132616-5d0b-4fdd-a94f-9a8314a1aec2 0003-2328 HUMAN PRESCRIPTION DRUG YERVOY ipilimumab INJECTION INTRAVENOUS 20110325 BLA BLA125377 E.R. Squibb & Sons, L.L.C. IPILIMUMAB 5 mg/mL CTLA-4-directed Blocking Antibody [EPC],CTLA-4-directed Antibody Interactions [MoA],Increased T Lymphocyte Activation [PE] N 20181231 0003-2560_4ea52814-9a61-4e3a-8426-f1e46d675437 0003-2560 HUMAN PRESCRIPTION DRUG AZACTAM AZTREONAM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100401 NDA NDA050580 E.R. Squibb & Sons, L.L.C. AZTREONAM 1 g/1 Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] N 20181231 0003-2570_4ea52814-9a61-4e3a-8426-f1e46d675437 0003-2570 HUMAN PRESCRIPTION DRUG AZACTAM AZTREONAM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100401 NDA NDA050580 E.R. Squibb & Sons, L.L.C. AZTREONAM 2 g/1 Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] N 20181231 0003-2814_5ada8930-df4f-4371-9229-c66142f2c249 0003-2814 HUMAN PRESCRIPTION DRUG ORENCIA abatacept INJECTION, SOLUTION SUBCUTANEOUS 20110729 BLA BLA125118 E.R. Squibb & Sons, L.L.C. ABATACEPT 50 mg/.4mL Decreased Cytokine Activity [PE],Selective T Cell Costimulation Modulator [EPC],Recombinant Fusion Proteins [Chemical/Ingredient] N 20181231 0003-2818_5ada8930-df4f-4371-9229-c66142f2c249 0003-2818 HUMAN PRESCRIPTION DRUG ORENCIA abatacept INJECTION, SOLUTION SUBCUTANEOUS 20110729 BLA BLA125118 E.R. Squibb & Sons, L.L.C. ABATACEPT 87.5 mg/.7mL Decreased Cytokine Activity [PE],Selective T Cell Costimulation Modulator [EPC],Recombinant Fusion Proteins [Chemical/Ingredient] N 20181231 0003-3622_5cada4d1-f42d-4412-ad98-01fd73a2ac57 0003-3622 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20030624 NDA NDA021567 E.R. Squibb & Sons, L.L.C. ATAZANAVIR SULFATE 300 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 0003-3624_5cada4d1-f42d-4412-ad98-01fd73a2ac57 0003-3624 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20030624 NDA NDA021567 E.R. Squibb & Sons, L.L.C. ATAZANAVIR SULFATE 150 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 0003-3631_5cada4d1-f42d-4412-ad98-01fd73a2ac57 0003-3631 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20030624 NDA NDA021567 E.R. Squibb & Sons, L.L.C. ATAZANAVIR SULFATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 0003-3638_5cada4d1-f42d-4412-ad98-01fd73a2ac57 0003-3638 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR POWDER ORAL 20141219 NDA NDA206352 E.R. Squibb & Sons, L.L.C. ATAZANAVIR SULFATE 50 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 0003-3641_a85ac210-0d90-457c-827b-7b7bc64681e2 0003-3641 HUMAN PRESCRIPTION DRUG EVOTAZ atazanavir and cobicistat TABLET ORAL 20150129 NDA NDA206353 E.R. Squibb & Sons, L.L.C. ATAZANAVIR SULFATE; COBICISTAT 300; 150 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 0003-3734_c59ea933-12f3-4bf7-be34-0b8f86fc6a4c 0003-3734 HUMAN PRESCRIPTION DRUG OPDIVO nivolumab INJECTION INTRAVENOUS 20171208 BLA BLA125554 E.R. Squibb & Sons, L.L.C. NIVOLUMAB 10 mg/mL Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA] N 20191231 0003-3764_9e15c2cb-e038-4ba5-a252-1e6299d1c6e9 0003-3764 HUMAN PRESCRIPTION DRUG ELIQUIS 30-Day Starter Pack apixaban KIT 20171129 NDA NDA202155 E.R. Squibb & Sons, L.L.C. N 20181231 0003-3772_c59ea933-12f3-4bf7-be34-0b8f86fc6a4c 0003-3772 HUMAN PRESCRIPTION DRUG OPDIVO nivolumab INJECTION INTRAVENOUS 20141222 BLA BLA125554 E.R. Squibb & Sons, L.L.C. NIVOLUMAB 10 mg/mL Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA] N 20191231 0003-3774_c59ea933-12f3-4bf7-be34-0b8f86fc6a4c 0003-3774 HUMAN PRESCRIPTION DRUG OPDIVO nivolumab INJECTION INTRAVENOUS 20141222 BLA BLA125554 E.R. Squibb & Sons, L.L.C. NIVOLUMAB 10 mg/mL Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA] N 20191231 0003-4522_ae608a81-e5f5-4f26-a061-47820341156e 0003-4522 HUMAN PRESCRIPTION DRUG EMPLICITI elotuzumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20151130 BLA BLA761035 E.R. Squibb & Sons, L.L.C. ELOTUZUMAB 400 mg/1 SLAMF7-directed Immunostimulatory Antibody [EPC],SLAMF7-directed Antibody Interactions [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 0003-5178_2f2e9096-5021-4425-8195-1cbd5d921dfc 0003-5178 HUMAN PRESCRIPTION DRUG PRAVACHOL PRAVASTATIN SODIUM TABLET ORAL 20090601 NDA NDA019898 E.R. Squibb & Sons, L.L.C. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0003-5194_2f2e9096-5021-4425-8195-1cbd5d921dfc 0003-5194 HUMAN PRESCRIPTION DRUG PRAVACHOL PRAVASTATIN SODIUM TABLET ORAL 20090601 NDA NDA019898 E.R. Squibb & Sons, L.L.C. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0003-5195_2f2e9096-5021-4425-8195-1cbd5d921dfc 0003-5195 HUMAN PRESCRIPTION DRUG PRAVACHOL PRAVASTATIN SODIUM TABLET ORAL 20090601 NDA NDA019898 E.R. Squibb & Sons, L.L.C. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0003-6335_95721160-ca36-4c03-90ee-eb438ab68466 0003-6335 HUMAN PRESCRIPTION DRUG DROXIA HYDROXYUREA CAPSULE ORAL 20090601 NDA NDA016295 E.R. Squibb & Sons, L.L.C. HYDROXYUREA 200 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] N 20181231 0003-6336_95721160-ca36-4c03-90ee-eb438ab68466 0003-6336 HUMAN PRESCRIPTION DRUG DROXIA HYDROXYUREA CAPSULE ORAL 20090601 NDA NDA016295 E.R. Squibb & Sons, L.L.C. HYDROXYUREA 300 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] N 20181231 0003-6337_95721160-ca36-4c03-90ee-eb438ab68466 0003-6337 HUMAN PRESCRIPTION DRUG DROXIA HYDROXYUREA CAPSULE ORAL 20090601 NDA NDA016295 E.R. Squibb & Sons, L.L.C. HYDROXYUREA 400 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] N 20181231 0004-0038_84ce6cb6-b581-43ca-b336-1071b6934a48 0004-0038 HUMAN PRESCRIPTION DRUG Valcyte valganciclovir hydrochloride TABLET, FILM COATED ORAL 20010329 NDA NDA021304 Genentech, Inc. VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 0004-0039_84ce6cb6-b581-43ca-b336-1071b6934a48 0004-0039 HUMAN PRESCRIPTION DRUG Valcyte valganciclovir hydrochloride POWDER, FOR SOLUTION ORAL 20090828 NDA NDA022257 Genentech, Inc. VALGANCICLOVIR HYDROCHLORIDE 50 mg/mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 0004-0058_ca698eaa-2fb4-448e-9fc5-17cfa929e5ef 0004-0058 HUMAN PRESCRIPTION DRUG Klonopin Clonazepam TABLET ORAL 19750602 NDA NDA017533 Genentech, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0004-0068_ca698eaa-2fb4-448e-9fc5-17cfa929e5ef 0004-0068 HUMAN PRESCRIPTION DRUG Klonopin Clonazepam TABLET ORAL 19750602 NDA NDA017533 Genentech, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0004-0098_ca698eaa-2fb4-448e-9fc5-17cfa929e5ef 0004-0098 HUMAN PRESCRIPTION DRUG Klonopin Clonazepam TABLET ORAL 19750602 NDA NDA017533 Genentech, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0004-0186_fae35673-d224-4cbf-b988-f35b5009e3df 0004-0186 HUMAN PRESCRIPTION DRUG Boniva ibandronate sodium TABLET, FILM COATED ORAL 20020715 NDA NDA021455 Genentech, Inc. IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0004-0191_2fbd353f-ae14-484d-a84b-d5b0e34173f3 0004-0191 HUMAN PRESCRIPTION DRUG Boniva ibandronate sodium INJECTION, SOLUTION INTRAVENOUS 20110601 NDA NDA021858 Genentech, Inc. IBANDRONATE SODIUM 3 mg/3mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 0004-0244_e282a35d-36a9-4b7a-bdae-d755319722f5 0004-0244 HUMAN PRESCRIPTION DRUG Invirase saquinavir mesylate TABLET, FILM COATED ORAL 20041217 NDA NDA021785 Genentech, Inc. SAQUINAVIR MESYLATE 500 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] N 20181231 0004-0245_e282a35d-36a9-4b7a-bdae-d755319722f5 0004-0245 HUMAN PRESCRIPTION DRUG Invirase saquinavir mesylate CAPSULE ORAL 19951206 NDA NDA020628 Genentech, Inc. SAQUINAVIR MESYLATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] N 20181231 0004-0257_a337e5d5-ba9d-4371-935b-fb8f8a4eec64 0004-0257 HUMAN PRESCRIPTION DRUG Xenical orlistat CAPSULE ORAL 20101217 NDA NDA020766 Genentech, Inc. ORLISTAT 120 mg/1 Intestinal Lipase Inhibitor [EPC],Lipase Inhibitors [MoA] N 20181231 0004-0259_f5c7571c-bfcb-40dd-8a0a-65e6e751b44b 0004-0259 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil CAPSULE ORAL 19950503 NDA NDA050722 Genentech, Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20191231 0004-0260_f5c7571c-bfcb-40dd-8a0a-65e6e751b44b 0004-0260 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil TABLET, FILM COATED ORAL 19970619 NDA NDA050723 Genentech, Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20191231 0004-0261_f5c7571c-bfcb-40dd-8a0a-65e6e751b44b 0004-0261 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil POWDER, FOR SUSPENSION ORAL 19981001 NDA NDA050759 Genentech, Inc. MYCOPHENOLATE MOFETIL 200 mg/mL Antimetabolite Immunosuppressant [EPC] N 20191231 0004-0298_f5c7571c-bfcb-40dd-8a0a-65e6e751b44b 0004-0298 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19980812 NDA NDA050758 Genentech, Inc. MYCOPHENOLATE MOFETIL HYDROCHLORIDE 500 mg/20mL Antimetabolite Immunosuppressant [EPC] N 20191231 0004-0350_7abd66a4-646d-4ca6-82b0-0736eb476058 0004-0350 HUMAN PRESCRIPTION DRUG Pegasys peginterferon alfa-2a INJECTION, SOLUTION SUBCUTANEOUS 20021016 BLA BLA103964 Genentech, Inc. PEGINTERFERON ALFA-2A 180 ug/mL Interferon alpha [EPC],peginterferon alfa-2a [Chemical/Ingredient] N 20181231 0004-0357_7abd66a4-646d-4ca6-82b0-0736eb476058 0004-0357 HUMAN PRESCRIPTION DRUG Pegasys peginterferon alfa-2a INJECTION, SOLUTION SUBCUTANEOUS 20110329 BLA BLA103964 Genentech, Inc. PEGINTERFERON ALFA-2A 180 ug/.5mL Interferon alpha [EPC],peginterferon alfa-2a [Chemical/Ingredient] N 20181231 0004-0360_7abd66a4-646d-4ca6-82b0-0736eb476058 0004-0360 HUMAN PRESCRIPTION DRUG Pegasys peginterferon alfa-2a INJECTION, SOLUTION SUBCUTANEOUS 20111101 BLA BLA103964 Genentech, Inc. PEGINTERFERON ALFA-2A 135 ug/.5mL Interferon alpha [EPC],peginterferon alfa-2a [Chemical/Ingredient] N 20181231 0004-0365_7abd66a4-646d-4ca6-82b0-0736eb476058 0004-0365 HUMAN PRESCRIPTION DRUG Pegasys peginterferon alfa-2a INJECTION, SOLUTION SUBCUTANEOUS 20111101 BLA BLA103964 Genentech, Inc. PEGINTERFERON ALFA-2A 180 ug/.5mL Interferon alpha [EPC],peginterferon alfa-2a [Chemical/Ingredient] N 20181231 0004-0381_125d42a9-0bdf-4d4c-8304-8448aa28bd23 0004-0381 HUMAN PRESCRIPTION DRUG FUZEON Enfuvirtide KIT 20120410 NDA NDA021481 Genentech, Inc. N 20181231 0004-0401_2f92af4c-a3cd-46f7-a171-2a90170955b4 0004-0401 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 20190531 BLA BLA125164 Genentech, Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 50 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 0004-0402_2f92af4c-a3cd-46f7-a171-2a90170955b4 0004-0402 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 20190731 BLA BLA125164 Genentech, Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 75 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 0004-0403_2f92af4c-a3cd-46f7-a171-2a90170955b4 0004-0403 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 20190731 BLA BLA125164 Genentech, Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 100 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 0004-0404_2f92af4c-a3cd-46f7-a171-2a90170955b4 0004-0404 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 20190731 BLA BLA125164 Genentech, Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 150 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 0004-0405_2f92af4c-a3cd-46f7-a171-2a90170955b4 0004-0405 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 20180630 BLA BLA125164 Genentech, Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 200 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 0004-0406_2f92af4c-a3cd-46f7-a171-2a90170955b4 0004-0406 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 20190731 BLA BLA125164 Genentech, Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 250 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 0004-0800_518ca3ad-8a15-457f-8073-e6e6dab211e2 0004-0800 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 19991027 NDA NDA021087 Genentech, Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 0004-0801_518ca3ad-8a15-457f-8073-e6e6dab211e2 0004-0801 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 19991027 NDA NDA021087 Genentech, Inc. OSELTAMIVIR PHOSPHATE 45 mg/1 N 20181231 0004-0802_518ca3ad-8a15-457f-8073-e6e6dab211e2 0004-0802 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 19991027 NDA NDA021087 Genentech, Inc. OSELTAMIVIR PHOSPHATE 30 mg/1 N 20181231 0004-0822_518ca3ad-8a15-457f-8073-e6e6dab211e2 0004-0822 HUMAN PRESCRIPTION DRUG Tamiflu Oseltamivir Phosphate POWDER, FOR SUSPENSION ORAL 20110321 NDA NDA021246 Genentech, Inc. OSELTAMIVIR PHOSPHATE 6 mg/mL N 20181231 0004-1100_6515b251-4608-4cbe-9fb2-1b377a09a6cb 0004-1100 HUMAN PRESCRIPTION DRUG Xeloda capecitabine TABLET, FILM COATED ORAL 19980430 NDA NDA020896 Genentech, Inc. CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0004-1101_6515b251-4608-4cbe-9fb2-1b377a09a6cb 0004-1101 HUMAN PRESCRIPTION DRUG Xeloda capecitabine TABLET, FILM COATED ORAL 19980430 NDA NDA020896 Genentech, Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0004-6203_517eb011-7a8b-42e8-9063-cd4d655601c1 0004-6203 HUMAN PRESCRIPTION DRUG Anaprox DS naproxen sodium TABLET ORAL 19800904 20180731 NDA NDA018164 Genentech, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 0004-6316_517eb011-7a8b-42e8-9063-cd4d655601c1 0004-6316 HUMAN PRESCRIPTION DRUG Naprosyn naproxen TABLET ORAL 19760311 20181031 NDA NDA017581 Genentech, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 0004-6415_517eb011-7a8b-42e8-9063-cd4d655601c1 0004-6415 HUMAN PRESCRIPTION DRUG EC-Naprosyn naproxen TABLET, DELAYED RELEASE ORAL 19941014 20190531 NDA NDA020067 Genentech, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 0004-6416_517eb011-7a8b-42e8-9063-cd4d655601c1 0004-6416 HUMAN PRESCRIPTION DRUG EC-Naprosyn naproxen TABLET, DELAYED RELEASE ORAL 19941014 20180731 NDA NDA020067 Genentech, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 0004-6940_88b961df-e52d-4477-a15f-00306b694951 0004-6940 HUMAN PRESCRIPTION DRUG Cytovene IV ganciclovir sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19890623 NDA NDA019661 Genentech, Inc. GANCICLOVIR SODIUM 500 mg/10mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 0005-0100_5d22327c-0253-4aac-87c9-5ecd15793ca8 0005-0100 VACCINE Trumenba meningococcal group B vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20141105 BLA BLA125549 Wyeth Pharmaceutical Division of Wyeth Holdings LLC, a subsidiary of Pfizer Inc. NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN; NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN 60; 60 ug/.5mL; ug/.5mL N 20191231 0005-1971_5515fa1d-4829-4390-970a-642304d9d936 0005-1971 VACCINE PREVNAR 13 pneumococcal 13-valent conjugate vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20100312 BLA BLA125324 Wyeth Pharmaceutical Division of Wyeth Holdings LLC, a subsidiary of Pfizer Inc. STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2; 2.2; 2.2; 2.2; 2.2; 4.4; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pneumococcal Vaccines [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Conjugate [Chemical/Ingredient] N 20181231 0005-2500_ffb6c98d-e53e-474b-a4c6-1bc7f02b90bb 0005-2500 HUMAN OTC DRUG FIBERCON CALCIUM POLYCARBOPHIL TABLET ORAL 20040105 OTC MONOGRAPH NOT FINAL part334 Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc. CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 0006-0005_d00b54da-7063-47e2-bb66-1c5723561200 0006-0005 HUMAN PRESCRIPTION DRUG BELSOMRA suvorexant TABLET, FILM COATED ORAL 20140829 NDA NDA204569 Merck Sharp & Dohme Corp. SUVOREXANT 5 mg/1 Orexin Receptor Antagonist [EPC],Orexin Receptor Antagonists [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] CIV N 20181231 0006-0019_f43abf9e-69d1-4a66-9125-195187fcb978 0006-0019 HUMAN PRESCRIPTION DRUG PRINIVIL lisinopril TABLET ORAL 19871229 NDA NDA019558 Merck Sharp & Dohme Corp. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0006-0031_d6630870-e0ee-4e4a-91bb-d2e578d097c2 0006-0031 HUMAN PRESCRIPTION DRUG FOSAMAX alendronate sodium TABLET ORAL 19950929 NDA NDA020560 Merck Sharp & Dohme Corp. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0006-0032_1bd71a49-88a0-4a58-8d78-13bd07871f6c 0006-0032 HUMAN PRESCRIPTION DRUG STROMECTOL ivermectin TABLET ORAL 19961122 NDA NDA050742 Merck Sharp & Dohme Corp. IVERMECTIN 3 mg/1 Antiparasitic [EPC],Pediculicide [EPC] N 20181231 0006-0033_d00b54da-7063-47e2-bb66-1c5723561200 0006-0033 HUMAN PRESCRIPTION DRUG BELSOMRA suvorexant TABLET, FILM COATED ORAL 20140829 NDA NDA204569 Merck Sharp & Dohme Corp. SUVOREXANT 10 mg/1 Orexin Receptor Antagonist [EPC],Orexin Receptor Antagonists [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] CIV N 20181231 0006-0071_f97459d2-f336-4904-b4fc-c24dcc27888a 0006-0071 HUMAN PRESCRIPTION DRUG PROPECIA finasteride TABLET, FILM COATED ORAL 19971219 NDA NDA020788 Merck Sharp & Dohme Corp. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 0006-0072_534ba8df-c573-489b-9b3f-f87a54cd994f 0006-0072 HUMAN PRESCRIPTION DRUG PROSCAR FINASTERIDE TABLET, FILM COATED ORAL 19920619 NDA NDA020180 Merck Sharp & Dohme Corp. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 0006-0078_ab9e9dd2-57db-4bfa-bd0d-ffc04a704d87 0006-0078 HUMAN PRESCRIPTION DRUG JANUMET XR sitagliptin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120202 NDA NDA202270 Merck Sharp & Dohme Corp. SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE 50; 500 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0006-0080_ab9e9dd2-57db-4bfa-bd0d-ffc04a704d87 0006-0080 HUMAN PRESCRIPTION DRUG JANUMET XR sitagliptin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120202 NDA NDA202270 Merck Sharp & Dohme Corp. SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE 50; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0006-0081_ab9e9dd2-57db-4bfa-bd0d-ffc04a704d87 0006-0081 HUMAN PRESCRIPTION DRUG JANUMET XR sitagliptin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120202 NDA NDA202270 Merck Sharp & Dohme Corp. SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE 100; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0006-0106_f43abf9e-69d1-4a66-9125-195187fcb978 0006-0106 HUMAN PRESCRIPTION DRUG PRINIVIL lisinopril TABLET ORAL 19871229 NDA NDA019558 Merck Sharp & Dohme Corp. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0006-0112_f9f3a9af-477e-4325-a8d6-ce8d675c9e9b 0006-0112 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Merck Sharp & Dohme Corp. SITAGLIPTIN PHOSPHATE 50 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 0006-0207_f43abf9e-69d1-4a66-9125-195187fcb978 0006-0207 HUMAN PRESCRIPTION DRUG PRINIVIL lisinopril TABLET ORAL 19871229 NDA NDA019558 Merck Sharp & Dohme Corp. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0006-0221_f9f3a9af-477e-4325-a8d6-ce8d675c9e9b 0006-0221 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Merck Sharp & Dohme Corp. SITAGLIPTIN PHOSPHATE 25 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 0006-0227_7e343355-1925-4aff-a510-b4575b11b6d4 0006-0227 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20071012 NDA NDA022145 Merck Sharp & Dohme Corp. RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] N 20181231 0006-0266_ba3f7068-96be-4e75-be96-c75ea78f09d4 0006-0266 HUMAN PRESCRIPTION DRUG MAXALT rizatriptan benzoate TABLET ORAL 19980629 NDA NDA020864 Merck Sharp & Dohme Corp. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0006-0267_ba3f7068-96be-4e75-be96-c75ea78f09d4 0006-0267 HUMAN PRESCRIPTION DRUG MAXALT rizatriptan benzoate TABLET ORAL 19980629 NDA NDA020864 Merck Sharp & Dohme Corp. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0006-0270_0184c6bc-b2db-4e60-94ec-0f4586c3b2f6 0006-0270 HUMAN PRESCRIPTION DRUG FOSAMAX PLUS D ALENDRONATE SODIUM and CHOLECALCIFEROL TABLET ORAL 20050407 NDA NDA021762 Merck Sharp & Dohme Corp. ALENDRONATE SODIUM; CHOLECALCIFEROL 70; 5600 mg/1; [iU]/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 0006-0277_f9f3a9af-477e-4325-a8d6-ce8d675c9e9b 0006-0277 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Merck Sharp & Dohme Corp. SITAGLIPTIN PHOSPHATE 100 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 0006-0325_d00b54da-7063-47e2-bb66-1c5723561200 0006-0325 HUMAN PRESCRIPTION DRUG BELSOMRA suvorexant TABLET, FILM COATED ORAL 20140829 NDA NDA204569 Merck Sharp & Dohme Corp. SUVOREXANT 15 mg/1 Orexin Receptor Antagonist [EPC],Orexin Receptor Antagonists [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] CIV N 20181231 0006-0335_d00b54da-7063-47e2-bb66-1c5723561200 0006-0335 HUMAN PRESCRIPTION DRUG BELSOMRA suvorexant TABLET, FILM COATED ORAL 20140829 NDA NDA204569 Merck Sharp & Dohme Corp. SUVOREXANT 20 mg/1 Orexin Receptor Antagonist [EPC],Orexin Receptor Antagonists [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] CIV N 20181231 0006-0351_ae634203-7414-4955-95ff-fa16cf025ab2 0006-0351 HUMAN PRESCRIPTION DRUG ZONTIVITY vorapaxar TABLET, FILM COATED ORAL 20140508 NDA NDA204886 Merck Sharp & Dohme Corp. VORAPAXAR SULFATE 2.08 mg/1 Protease-activated Receptor-1 Antagonist [EPC],Protease-activated Receptor-1 Antagonists [MoA] N 20181231 0006-0461_9d4c63df-4a74-4ee4-8df0-78b6283591cb 0006-0461 HUMAN PRESCRIPTION DRUG EMEND aprepitant CAPSULE ORAL 20030326 NDA NDA021549 Merck Sharp & Dohme Corp. APREPITANT 80 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 0006-0462_9d4c63df-4a74-4ee4-8df0-78b6283591cb 0006-0462 HUMAN PRESCRIPTION DRUG EMEND aprepitant CAPSULE ORAL 20030326 NDA NDA021549 Merck Sharp & Dohme Corp. APREPITANT 125 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 0006-0464_9d4c63df-4a74-4ee4-8df0-78b6283591cb 0006-0464 HUMAN PRESCRIPTION DRUG EMEND aprepitant CAPSULE ORAL 20030326 NDA NDA021549 Merck Sharp & Dohme Corp. APREPITANT 40 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 0006-0473_7e343355-1925-4aff-a510-b4575b11b6d4 0006-0473 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, CHEWABLE ORAL 20111221 NDA NDA203045 Merck Sharp & Dohme Corp. RALTEGRAVIR POTASSIUM 25 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] N 20181231 0006-0477_7e343355-1925-4aff-a510-b4575b11b6d4 0006-0477 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, CHEWABLE ORAL 20111221 NDA NDA203045 Merck Sharp & Dohme Corp. RALTEGRAVIR POTASSIUM 100 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] N 20181231 0006-0543_f57237f9-1282-4beb-afe6-6fc13b474e2c 0006-0543 HUMAN PRESCRIPTION DRUG ZOCOR SIMVASTATIN TABLET, FILM COATED ORAL 19911223 NDA NDA019766 Merck Sharp & Dohme Corp. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0006-0568_87947de5-7d26-41bf-be8b-10cf3a6f28c3 0006-0568 HUMAN PRESCRIPTION DRUG ZOLINZA vorinostat CAPSULE ORAL 20061006 NDA NDA021991 Merck Sharp & Dohme Corp. VORINOSTAT 100 mg/1 Histone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA] N 20181231 0006-0571_c257f3d4-d499-41fa-9161-1ec22456ab16 0006-0571 HUMAN PRESCRIPTION DRUG CRIXIVAN indinavir sulfate CAPSULE ORAL 19960313 NDA NDA020685 Merck Sharp & Dohme Corp. INDINAVIR SULFATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 0006-0573_c257f3d4-d499-41fa-9161-1ec22456ab16 0006-0573 HUMAN PRESCRIPTION DRUG CRIXIVAN indinavir sulfate CAPSULE ORAL 19960313 NDA NDA020685 Merck Sharp & Dohme Corp. INDINAVIR SULFATE 400 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 0006-0575_1702daca-0ba2-476b-a9a3-0b977320b868 0006-0575 HUMAN PRESCRIPTION DRUG JANUMET SITAGLIPTIN and METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20070330 NDA NDA022044 Merck Sharp & Dohme Corp. SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE 50; 500 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0006-0577_1702daca-0ba2-476b-a9a3-0b977320b868 0006-0577 HUMAN PRESCRIPTION DRUG JANUMET SITAGLIPTIN and METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20070330 NDA NDA022044 Merck Sharp & Dohme Corp. SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE 50; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0006-0710_0184c6bc-b2db-4e60-94ec-0f4586c3b2f6 0006-0710 HUMAN PRESCRIPTION DRUG FOSAMAX PLUS D ALENDRONATE SODIUM and CHOLECALCIFEROL TABLET ORAL 20050407 NDA NDA021762 Merck Sharp & Dohme Corp. ALENDRONATE SODIUM; CHOLECALCIFEROL 70; 2800 mg/1; [iU]/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 0006-0717_380f864a-e812-4c80-b2b0-41d3347d2ecc 0006-0717 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Merck Sharp & Dohme Corp. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0006-0726_f57237f9-1282-4beb-afe6-6fc13b474e2c 0006-0726 HUMAN PRESCRIPTION DRUG ZOCOR SIMVASTATIN TABLET, FILM COATED ORAL 19911223 NDA NDA019766 Merck Sharp & Dohme Corp. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0006-0735_f57237f9-1282-4beb-afe6-6fc13b474e2c 0006-0735 HUMAN PRESCRIPTION DRUG ZOCOR SIMVASTATIN TABLET, FILM COATED ORAL 19911223 NDA NDA019766 Merck Sharp & Dohme Corp. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0006-0740_f57237f9-1282-4beb-afe6-6fc13b474e2c 0006-0740 HUMAN PRESCRIPTION DRUG ZOCOR SIMVASTATIN TABLET, FILM COATED ORAL 19911223 NDA NDA019766 Merck Sharp & Dohme Corp. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0006-0745_380f864a-e812-4c80-b2b0-41d3347d2ecc 0006-0745 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Merck Sharp & Dohme Corp. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0006-0747_380f864a-e812-4c80-b2b0-41d3347d2ecc 0006-0747 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Merck Sharp & Dohme Corp. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0006-0749_f57237f9-1282-4beb-afe6-6fc13b474e2c 0006-0749 HUMAN PRESCRIPTION DRUG ZOCOR SIMVASTATIN TABLET, FILM COATED ORAL 19911223 NDA NDA019766 Merck Sharp & Dohme Corp. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0006-0951_44a1f564-b09f-48d3-b3a8-8b1cb5f6a7cf 0006-0951 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Merck Sharp & Dohme Corp. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0006-0952_44a1f564-b09f-48d3-b3a8-8b1cb5f6a7cf 0006-0952 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Merck Sharp & Dohme Corp. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0006-0960_44a1f564-b09f-48d3-b3a8-8b1cb5f6a7cf 0006-0960 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Merck Sharp & Dohme Corp. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0006-1711_cf56f56a-26fc-4add-9dcd-b7ef4842f3d8 0006-1711 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Merck Sharp & Dohme Corp. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0006-3025_d6c5254f-8153-4861-b4ad-6f439fed4b63 0006-3025 HUMAN PRESCRIPTION DRUG ZINPLAVA bezlotoxumab INJECTION, SOLUTION INTRAVENOUS 20161021 BLA BLA761046 Merck Sharp & Dohme Corp. BEZLOTOXUMAB 25 mg/mL N 20181231 0006-3026_f58c107b-8a87-4900-8956-4e712a777135 0006-3026 HUMAN PRESCRIPTION DRUG KEYTRUDA pembrolizumab INJECTION, SOLUTION INTRAVENOUS 20150115 BLA BLA125514 Merck Sharp & Dohme Corp. PEMBROLIZUMAB 25 mg/mL Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA] N 20181231 0006-3029_f58c107b-8a87-4900-8956-4e712a777135 0006-3029 HUMAN PRESCRIPTION DRUG KEYTRUDA pembrolizumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140904 BLA BLA125514 Merck Sharp & Dohme Corp. PEMBROLIZUMAB 50 mg/2mL Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA] N 20181231 0006-3061_8ae181cc-f15d-436d-80aa-e880e217ddeb 0006-3061 HUMAN PRESCRIPTION DRUG EMEND FOSAPREPITANT DIMEGLUMINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170203 NDA NDA022023 Merck Sharp & Dohme Corp. FOSAPREPITANT DIMEGLUMINE 150 mg/5mL Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 0006-3066_9d4c63df-4a74-4ee4-8df0-78b6283591cb 0006-3066 HUMAN PRESCRIPTION DRUG EMEND aprepitant POWDER, FOR SUSPENSION ORAL 20151217 NDA NDA207865 Merck Sharp & Dohme Corp. APREPITANT 125 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 0006-3074_30a49979-8cc3-44a5-ac07-1e3618f15dda 0006-3074 HUMAN PRESCRIPTION DRUG ZEPATIER elbasvir and grazoprevir TABLET, FILM COATED ORAL 20160128 NDA NDA208261 Merck Sharp & Dohme Corp. ELBASVIR; GRAZOPREVIR ANHYDROUS 50; 100 mg/1; mg/1 Hepatitis C Virus NS5A Inhibitor [EPC],Breast Cancer Resistance Protein Inhibitors [MoA],HCV NS3/4A Protease Inhibitors [MoA],Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 0006-3075_ba203a36-72c6-417a-a1e9-98e1b88a9d8d 0006-3075 HUMAN PRESCRIPTION DRUG PREVYMIS LETERMOVIR TABLET, FILM COATED ORAL 20171108 NDA NDA209939 Merck Sharp & Dohme Corp. LETERMOVIR 240 mg/1 N 20181231 0006-3076_ba203a36-72c6-417a-a1e9-98e1b88a9d8d 0006-3076 HUMAN PRESCRIPTION DRUG PREVYMIS LETERMOVIR TABLET, FILM COATED ORAL 20171108 NDA NDA209939 Merck Sharp & Dohme Corp. LETERMOVIR 480 mg/1 N 20181231 0006-3080_7e343355-1925-4aff-a510-b4575b11b6d4 0006-3080 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20170526 NDA NDA022145 Merck Sharp & Dohme Corp. RALTEGRAVIR POTASSIUM 600 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] N 20181231 0006-3516_5a448350-9d1c-4af3-b22f-17c91e5fcb08 0006-3516 HUMAN PRESCRIPTION DRUG PRIMAXIN IV imipenem and cilastatin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19851126 NDA NDA050587 Merck Sharp & Dohme Corp. IMIPENEM; CILASTATIN SODIUM 500; 500 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] N 20191231 0006-3519_0ab2a390-2925-4b2c-98d3-24f338eee2c2 0006-3519 HUMAN PRESCRIPTION DRUG TRUSOPT dorzolamide hydrochloride SOLUTION OPHTHALMIC 19941209 NDA NDA020408 Merck Sharp & Dohme Corp. DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] N 20181231 0006-3603_7e343355-1925-4aff-a510-b4575b11b6d4 0006-3603 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR GRANULE, FOR SUSPENSION ORAL 20131220 NDA NDA205786 Merck Sharp & Dohme Corp. RALTEGRAVIR POTASSIUM 100 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] N 20181231 0006-3800_ba3f7068-96be-4e75-be96-c75ea78f09d4 0006-3800 HUMAN PRESCRIPTION DRUG MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 19980629 NDA NDA020865 Merck Sharp & Dohme Corp. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0006-3801_ba3f7068-96be-4e75-be96-c75ea78f09d4 0006-3801 HUMAN PRESCRIPTION DRUG MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 19980629 NDA NDA020865 Merck Sharp & Dohme Corp. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0006-3822_df4a2f99-0b41-4727-86ce-e50c18078089 0006-3822 HUMAN PRESCRIPTION DRUG CANCIDAS CASPOFUNGIN ACETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010126 NDA NDA021227 Merck Sharp & Dohme Corp. CASPOFUNGIN ACETATE 5 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 0006-3823_df4a2f99-0b41-4727-86ce-e50c18078089 0006-3823 HUMAN PRESCRIPTION DRUG CANCIDAS CASPOFUNGIN ACETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010126 NDA NDA021227 Merck Sharp & Dohme Corp. CASPOFUNGIN ACETATE 7 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 0006-3841_cf56f56a-26fc-4add-9dcd-b7ef4842f3d8 0006-3841 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium GRANULE ORAL 20020726 NDA NDA021409 Merck Sharp & Dohme Corp. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0006-3843_424b0d88-6662-498a-9aff-68b7bba48d14 0006-3843 HUMAN PRESCRIPTION DRUG INVANZ ertapenem sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20011121 NDA NDA021337 Merck Sharp & Dohme Corp. ERTAPENEM SODIUM 1 g/1 Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 0006-3845_424b0d88-6662-498a-9aff-68b7bba48d14 0006-3845 HUMAN PRESCRIPTION DRUG INVANZ ertapenem sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20011121 NDA NDA021337 Merck Sharp & Dohme Corp. ERTAPENEM SODIUM 1 g/1 Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 0006-3862_9d4c63df-4a74-4ee4-8df0-78b6283591cb 0006-3862 HUMAN PRESCRIPTION DRUG EMEND aprepitant KIT 20030326 NDA NDA021549 Merck Sharp & Dohme Corp. N 20181231 0006-3915_6145f3e9-40af-4662-896e-5953bff18453 0006-3915 HUMAN PRESCRIPTION DRUG SINEMET carbidopa and levodopa TABLET ORAL 19750502 NDA NDA017555 Merck Sharp & Dohme Corp. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0006-3916_6145f3e9-40af-4662-896e-5953bff18453 0006-3916 HUMAN PRESCRIPTION DRUG SINEMET carbidopa and levodopa TABLET ORAL 19750502 NDA NDA017555 Merck Sharp & Dohme Corp. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0006-3917_6145f3e9-40af-4662-896e-5953bff18453 0006-3917 HUMAN PRESCRIPTION DRUG SINEMET carbidopa and levodopa TABLET ORAL 19750502 NDA NDA017555 Merck Sharp & Dohme Corp. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0006-3918_6f98927f-48cd-4c54-a67d-f318eac3e5fe 0006-3918 HUMAN PRESCRIPTION DRUG SINEMET CR carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 19910530 NDA NDA019856 Merck Sharp & Dohme Corp. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0006-3919_6f98927f-48cd-4c54-a67d-f318eac3e5fe 0006-3919 HUMAN PRESCRIPTION DRUG SINEMET CR carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 19910530 NDA NDA019856 Merck Sharp & Dohme Corp. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0006-3941_8cd0485e-e39f-4502-8dad-31a578310940 0006-3941 HUMAN PRESCRIPTION DRUG EMEND FOSAPREPITANT DIMEGLUMINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20101112 NDA NDA022023 Merck Sharp & Dohme Corp. FOSAPREPITANT DIMEGLUMINE 150 mg/5mL Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 0006-4045_ea7d9f17-ddb6-44bb-a120-739643deae36 0006-4045 VACCINE GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant INJECTION, SUSPENSION INTRAMUSCULAR 20060608 BLA BLA125126 Merck Sharp & Dohme Corp. HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN 20; 40; 40; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20191231 0006-4047_f4fa79ca-b0fe-49bc-9c58-8b85032b9f7f 0006-4047 VACCINE RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent SOLUTION ORAL 20060203 BLA BLA125122 Merck Sharp & Dohme Corp. HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN; HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN 2200000; 2800000; 2200000; 2000000; 2300000 [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL; [iU]/2mL Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient],Live Rotavirus Vaccine [EPC],Actively Acquired Immunity [PE],Rotavirus Vaccines [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient] N 20181231 0006-4093_1644ba2a-c49d-4c92-afe5-3fd922dbc8ae 0006-4093 VACCINE RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR; SUBCUTANEOUS 19860723 BLA BLA101066 Merck Sharp & Dohme Corp. HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 5 ug/.5mL Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4094_1644ba2a-c49d-4c92-afe5-3fd922dbc8ae 0006-4094 VACCINE RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR; SUBCUTANEOUS 19860723 BLA BLA101066 Merck Sharp & Dohme Corp. HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 10 ug/mL Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4095_9ae11ba9-4ab4-476e-82ad-921333bbdb7d 0006-4095 VACCINE VAQTA hepatitis A vaccine, inactivated INJECTION, SUSPENSION INTRAMUSCULAR 19960329 BLA BLA103606 Merck Sharp & Dohme Corp. HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU]/.5mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4096_9ae11ba9-4ab4-476e-82ad-921333bbdb7d 0006-4096 VACCINE VAQTA hepatitis A vaccine, inactivated INJECTION, SUSPENSION INTRAMUSCULAR 19960329 BLA BLA103606 Merck Sharp & Dohme Corp. HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 50 [iU]/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4109_ea7d9f17-ddb6-44bb-a120-739643deae36 0006-4109 VACCINE GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant INJECTION, SUSPENSION INTRAMUSCULAR 20060608 BLA BLA125126 Merck Sharp & Dohme Corp. HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN 20; 40; 40; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20191231 0006-4119_0c296c36-30ae-444e-8d2d-4c8e0372f244 0006-4119 VACCINE GARDASIL 9 Human Papillomavirus 9-valent Vaccine, Recombinant INJECTION, SUSPENSION INTRAMUSCULAR 20141210 BLA BLA125508 Merck Sharp & Dohme Corp. HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN 30; 40; 60; 40; 20; 20; 20; 20; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4121_0c296c36-30ae-444e-8d2d-4c8e0372f244 0006-4121 VACCINE GARDASIL 9 Human Papillomavirus 9-valent Vaccine, Recombinant INJECTION, SUSPENSION INTRAMUSCULAR 20141210 BLA BLA125508 Merck Sharp & Dohme Corp. HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN 30; 40; 60; 40; 20; 20; 20; 20; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4171_cc108426-2c58-4ca0-948d-be5cd758bd70 0006-4171 VACCINE ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 20150701 BLA BLA125108 Merck Sharp & Dohme Corp. MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN; MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN; RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN; VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 1000; 20000; 1000; 9772 [TCID_50]/.5mL; [TCID_50]/.5mL; [TCID_50]/.5mL; [PFU]/.5mL Live Attenuated Measles Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Measles Vaccine [Chemical/Ingredient],Live Attenuated Mumps Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Mumps Vaccine [Chemical/Ingredient],Live Attenuated Rubella Virus Vaccine [EPC],Actively Acquired Immunity [PE],Rubella Vaccine [Chemical/Ingredient],Vaccines, Attenuated [Chemical/Ingredient],Live Attenuated Varicella Zoster Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Chickenpox Vaccine [Chemical/Ingredient],Live Attenuated Herpes Zoster Virus Vaccine [EPC],Herpes Zoster Vaccine [Chemical/Ingredient] N 20181231 0006-4229_b7a32150-e15a-4109-93b8-a2368039e033 0006-4229 STANDARDIZED ALLERGENIC GRASTEK Timothy Grass Pollen Allergen Extract TABLET SUBLINGUAL 20140411 BLA BLA125473 Merck Sharp & Dohme Corp. PHLEUM PRATENSE POLLEN 2800 [BAU]/1 Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0006-4305_2949009c-3361-4961-b096-bb5362223aff 0006-4305 HUMAN PRESCRIPTION DRUG Renflexis infliximab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170701 BLA BLA761054 Merck Sharp & Dohme Corp. INFLIXIMAB, LICENSE HOLDER UNSPECIFIED 100 mg/1 Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] N 20181231 0006-4309_e4ce356e-321e-4709-a664-9a7c196a3237 0006-4309 VACCINE STERILE DILUENT Sterile Water INJECTION SUBCUTANEOUS 20060525 BLA BLA125123 Merck Sharp & Dohme Corp. N 20181231 0006-4681_d773f47d-06b4-4ba9-bb39-4b25e03e0c13 0006-4681 VACCINE M-M-R II measles, mumps, and rubella virus vaccine live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 19710421 BLA BLA101069 Merck Sharp & Dohme Corp. MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN; MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN; RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN 1000; 12500; 1000 [TCID_50]/.5mL; [TCID_50]/.5mL; [TCID_50]/.5mL Live Attenuated Measles Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Measles Vaccine [Chemical/Ingredient],Live Attenuated Mumps Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Mumps Vaccine [Chemical/Ingredient],Live Attenuated Rubella Virus Vaccine [EPC],Actively Acquired Immunity [PE],Rubella Vaccine [Chemical/Ingredient],Vaccines, Attenuated [Chemical/Ingredient] N 20181231 0006-4739_071f8653-783b-4628-b0f6-7d26317b50ca 0006-4739 VACCINE PNEUMOVAX 23 pneumococcal vaccine polyvalent INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 19830707 BLA BLA101094 Merck Sharp & Dohme Corp. STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4826_57f23194-526d-47d5-b2d0-d5cf06c7b544 0006-4826 VACCINE VARIVAX Varicella Virus Vaccine Live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 19950317 BLA BLA103552 Merck Sharp & Dohme Corp. VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 1350 [PFU]/.5mL Live Attenuated Varicella Zoster Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Chickenpox Vaccine [Chemical/Ingredient],Live Attenuated Herpes Zoster Virus Vaccine [EPC],Herpes Zoster Vaccine [Chemical/Ingredient] N 20181231 0006-4827_57f23194-526d-47d5-b2d0-d5cf06c7b544 0006-4827 VACCINE VARIVAX Varicella Virus Vaccine Live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 19950317 BLA BLA103552 Merck Sharp & Dohme Corp. VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 1350 [PFU]/.5mL Live Attenuated Varicella Zoster Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Chickenpox Vaccine [Chemical/Ingredient],Live Attenuated Herpes Zoster Virus Vaccine [EPC],Herpes Zoster Vaccine [Chemical/Ingredient] N 20181231 0006-4831_9ae11ba9-4ab4-476e-82ad-921333bbdb7d 0006-4831 VACCINE VAQTA hepatitis A vaccine, inactivated INJECTION, SUSPENSION INTRAMUSCULAR 19960329 BLA BLA103606 Merck Sharp & Dohme Corp. HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU]/.5mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4837_071f8653-783b-4628-b0f6-7d26317b50ca 0006-4837 VACCINE PNEUMOVAX 23 pneumococcal vaccine polyvalent INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20140721 BLA BLA101094 Merck Sharp & Dohme Corp. STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4841_9ae11ba9-4ab4-476e-82ad-921333bbdb7d 0006-4841 VACCINE VAQTA hepatitis A vaccine, inactivated INJECTION, SUSPENSION INTRAMUSCULAR 19960329 BLA BLA103606 Merck Sharp & Dohme Corp. HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 50 [iU]/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4897_5dfd7555-5a7c-4c33-ab30-3228bf03eaa0 0006-4897 VACCINE PedvaxHIB Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) INJECTION, SUSPENSION INTRAMUSCULAR 19891220 BLA BLA103237 Merck Sharp & Dohme Corp. HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN 7.5 ug/.5mL Inactivated Haemophilus Influenzae B Vaccine [EPC],Actively Acquired Immunity [PE],Haemophilus Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20191231 0006-4943_071f8653-783b-4628-b0f6-7d26317b50ca 0006-4943 VACCINE PNEUMOVAX 23 pneumococcal vaccine polyvalent INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 19830707 BLA BLA101094 Merck Sharp & Dohme Corp. STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4963_e4ce356e-321e-4709-a664-9a7c196a3237 0006-4963 VACCINE ZOSTAVAX Zoster Vaccine Live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 20060525 BLA BLA125123 Merck Sharp & Dohme Corp. VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 19400 [PFU]/.65mL Live Attenuated Varicella Zoster Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Chickenpox Vaccine [Chemical/Ingredient],Live Attenuated Herpes Zoster Virus Vaccine [EPC],Herpes Zoster Vaccine [Chemical/Ingredient] N 20181231 0006-4981_1644ba2a-c49d-4c92-afe5-3fd922dbc8ae 0006-4981 VACCINE RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR; SUBCUTANEOUS 19860723 BLA BLA101066 Merck Sharp & Dohme Corp. HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 5 ug/.5mL Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4992_1644ba2a-c49d-4c92-afe5-3fd922dbc8ae 0006-4992 VACCINE RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR; SUBCUTANEOUS 19860723 BLA BLA101066 Merck Sharp & Dohme Corp. HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 40 ug/mL Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4995_1644ba2a-c49d-4c92-afe5-3fd922dbc8ae 0006-4995 VACCINE RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR; SUBCUTANEOUS 19860723 BLA BLA101066 Merck Sharp & Dohme Corp. HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 10 ug/mL Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 0006-4999_a67e41dc-692e-4f4f-b931-36e4ea467d9c 0006-4999 VACCINE ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 20050906 BLA BLA125108 Merck Sharp & Dohme Corp. MEASLES VIRUS STRAIN ENDERS' ATTENUATED EDMONSTON LIVE ANTIGEN; MUMPS VIRUS STRAIN B LEVEL JERYL LYNN LIVE ANTIGEN; RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN; VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 1000; 20000; 1000; 9772 [TCID_50]/.5mL; [TCID_50]/.5mL; [TCID_50]/.5mL; [PFU]/.5mL Live Attenuated Measles Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Measles Vaccine [Chemical/Ingredient],Live Attenuated Mumps Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Mumps Vaccine [Chemical/Ingredient],Live Attenuated Rubella Virus Vaccine [EPC],Actively Acquired Immunity [PE],Rubella Vaccine [Chemical/Ingredient],Vaccines, Attenuated [Chemical/Ingredient],Live Attenuated Varicella Zoster Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Chickenpox Vaccine [Chemical/Ingredient],Live Attenuated Herpes Zoster Virus Vaccine [EPC],Herpes Zoster Vaccine [Chemical/Ingredient] N 20181231 0006-5003_ba203a36-72c6-417a-a1e9-98e1b88a9d8d 0006-5003 HUMAN PRESCRIPTION DRUG PREVYMIS LETERMOVIR INJECTION, SOLUTION INTRAVENOUS 20171108 NDA NDA209940 Merck Sharp & Dohme Corp. LETERMOVIR 20 mg/mL N 20181231 0006-5004_ba203a36-72c6-417a-a1e9-98e1b88a9d8d 0006-5004 HUMAN PRESCRIPTION DRUG PREVYMIS LETERMOVIR INJECTION, SOLUTION INTRAVENOUS 20171108 NDA NDA209940 Merck Sharp & Dohme Corp. LETERMOVIR 20 mg/mL N 20181231 0006-5363_8230ae6b-12e6-47c1-b9df-a46857d907a3 0006-5363 HUMAN PRESCRIPTION DRUG STEGLATRO ertugliflozin TABLET, FILM COATED ORAL 20171219 NDA NDA209803 Merck Sharp & Dohme Corp. ERTUGLIFLOZIN PIDOLATE 5 mg/1 N 20181231 0006-5364_8230ae6b-12e6-47c1-b9df-a46857d907a3 0006-5364 HUMAN PRESCRIPTION DRUG STEGLATRO ertugliflozin TABLET, FILM COATED ORAL 20171219 NDA NDA209803 Merck Sharp & Dohme Corp. ERTUGLIFLOZIN PIDOLATE 15 mg/1 N 20181231 0006-5367_1b6dc23d-b20b-4030-ac15-06ab8915b76d 0006-5367 HUMAN PRESCRIPTION DRUG STEGLUJAN ertugliflozin and sitagliptin TABLET, FILM COATED ORAL 20171219 NDA NDA209805 Merck Sharp & Dohme Corp. ERTUGLIFLOZIN PIDOLATE; SITAGLIPTIN PHOSPHATE 5; 100 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 0006-5368_1b6dc23d-b20b-4030-ac15-06ab8915b76d 0006-5368 HUMAN PRESCRIPTION DRUG STEGLUJAN ertugliflozin and sitagliptin TABLET, FILM COATED ORAL 20171219 NDA NDA209805 Merck Sharp & Dohme Corp. ERTUGLIFLOZIN PIDOLATE; SITAGLIPTIN PHOSPHATE 15; 100 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 0006-5369_ce472b71-60e4-4335-a329-93220c4e56cb 0006-5369 HUMAN PRESCRIPTION DRUG SEGLUROMET ertugliflozin and metformin hydrochloride TABLET, FILM COATED ORAL 20171219 NDA NDA209806 Merck Sharp & Dohme Corp. ERTUGLIFLOZIN PIDOLATE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0006-5370_ce472b71-60e4-4335-a329-93220c4e56cb 0006-5370 HUMAN PRESCRIPTION DRUG SEGLUROMET ertugliflozin and metformin hydrochloride TABLET, FILM COATED ORAL 20171219 NDA NDA209806 Merck Sharp & Dohme Corp. ERTUGLIFLOZIN PIDOLATE; METFORMIN HYDROCHLORIDE 7.5; 500 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0006-5373_ce472b71-60e4-4335-a329-93220c4e56cb 0006-5373 HUMAN PRESCRIPTION DRUG SEGLUROMET ertugliflozin and metformin hydrochloride TABLET, FILM COATED ORAL 20171219 NDA NDA209806 Merck Sharp & Dohme Corp. ERTUGLIFLOZIN PIDOLATE; METFORMIN HYDROCHLORIDE 2.5; 1000 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0006-5374_ce472b71-60e4-4335-a329-93220c4e56cb 0006-5374 HUMAN PRESCRIPTION DRUG SEGLUROMET ertugliflozin and metformin hydrochloride TABLET, FILM COATED ORAL 20171219 NDA NDA209806 Merck Sharp & Dohme Corp. ERTUGLIFLOZIN PIDOLATE; METFORMIN HYDROCHLORIDE 7.5; 1000 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0006-5420_214a1afa-d839-4f61-99ad-1b65cf7c0b5f 0006-5420 STANDARDIZED ALLERGENIC RAGWITEK Short Ragweed Pollen Allergen Extract TABLET SUBLINGUAL 20140417 BLA BLA125478 Merck Sharp & Dohme Corp. AMBROSIA ARTEMISIIFOLIA POLLEN 12 [Amb'a'1'U]/1 Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0006-5423_dc8ac7d3-52d0-4e6b-b301-04f0013ddbaf 0006-5423 HUMAN PRESCRIPTION DRUG BRIDION sugammadex INJECTION, SOLUTION INTRAVENOUS 20151215 NDA NDA022225 Merck Sharp & Dohme Corp. SUGAMMADEX SODIUM 100 mg/mL gamma-Cyclodextrins [Chemical/Ingredient] N 20181231 0006-5424_b1cd0874-ad29-49d3-a15f-6631fbd75e9a 0006-5424 PLASMA DERIVATIVE ANTIVENIN Latrodectus mactans KIT 20141201 BLA BLA101062 Merck Sharp & Dohme Corp. N 20181231 0006-5425_dc8ac7d3-52d0-4e6b-b301-04f0013ddbaf 0006-5425 HUMAN PRESCRIPTION DRUG BRIDION sugammadex INJECTION, SOLUTION INTRAVENOUS 20151215 NDA NDA022225 Merck Sharp & Dohme Corp. SUGAMMADEX SODIUM 100 mg/mL gamma-Cyclodextrins [Chemical/Ingredient] N 20181231 0006-9117_cf56f56a-26fc-4add-9dcd-b7ef4842f3d8 0006-9117 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 19980220 NDA NDA020829 Merck Sharp & Dohme Corp. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0006-9275_cf56f56a-26fc-4add-9dcd-b7ef4842f3d8 0006-9275 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Merck Sharp & Dohme Corp. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0007-3370_c4959761-0667-4cf6-bf8b-f45dfd7b90f3 0007-3370 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070209 NDA NDA022012 GlaxoSmithKline LLC CARVEDILOL PHOSPHATE 10 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0007-3371_c4959761-0667-4cf6-bf8b-f45dfd7b90f3 0007-3371 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070206 NDA NDA022012 GlaxoSmithKline LLC CARVEDILOL PHOSPHATE 20 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0007-3372_c4959761-0667-4cf6-bf8b-f45dfd7b90f3 0007-3372 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070214 NDA NDA022012 GlaxoSmithKline LLC CARVEDILOL PHOSPHATE 40 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0007-3373_c4959761-0667-4cf6-bf8b-f45dfd7b90f3 0007-3373 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070220 NDA NDA022012 GlaxoSmithKline LLC CARVEDILOL PHOSPHATE 80 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0007-3650_25b16f40-16dd-429b-ba22-5878756b0fe1 0007-3650 HUMAN PRESCRIPTION DRUG DYAZIDE hydrochlorothiazide and triamterene CAPSULE ORAL 19940330 NDA NDA016042 GlaxoSmithKline LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 0007-4139_c5a7f342-854f-4b98-9c44-b7b0af20d85b 0007-4139 HUMAN PRESCRIPTION DRUG COREG carvedilol TABLET, FILM COATED ORAL 19970603 NDA NDA020297 GlaxoSmithKline LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0007-4140_c5a7f342-854f-4b98-9c44-b7b0af20d85b 0007-4140 HUMAN PRESCRIPTION DRUG COREG carvedilol TABLET, FILM COATED ORAL 19970603 NDA NDA020297 GlaxoSmithKline LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0007-4141_c5a7f342-854f-4b98-9c44-b7b0af20d85b 0007-4141 HUMAN PRESCRIPTION DRUG COREG carvedilol TABLET, FILM COATED ORAL 19970603 NDA NDA020297 GlaxoSmithKline LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0007-4142_c5a7f342-854f-4b98-9c44-b7b0af20d85b 0007-4142 HUMAN PRESCRIPTION DRUG COREG carvedilol TABLET, FILM COATED ORAL 19970603 NDA NDA020297 GlaxoSmithKline LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0007-4201_4b6b5cfd-1780-447c-80b1-498116b63c60 0007-4201 HUMAN PRESCRIPTION DRUG HYCAMTIN topotecan hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960607 20180731 NDA NDA020671 GlaxoSmithKline LLC TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0007-4401_22b8c921-10d4-4a4f-9811-384d2b98853b 0007-4401 HUMAN PRESCRIPTION DRUG ARRANON nelarabine INJECTION INTRAVENOUS 20060119 20181231 NDA NDA021877 GlaxoSmithKline LLC NELARABINE 5 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 0007-4407_a9c4073f-2fd4-4d73-8bd9-3757bdbd722a 0007-4407 HUMAN PRESCRIPTION DRUG ARGATROBAN argatroban INJECTION, SOLUTION INTRAVENOUS 20001128 20180831 NDA NDA020883 GlaxoSmithKline LLC ARGATROBAN 100 mg/mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20191231 0007-4640_c7c46a73-1f77-45f6-ab60-1aa8f9e87463 0007-4640 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20081124 20190430 NDA NDA022291 GlaxoSmithKline LLC ELTROMBOPAG OLAMINE 25 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA] N 20181231 0007-4641_c7c46a73-1f77-45f6-ab60-1aa8f9e87463 0007-4641 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20081124 20190430 NDA NDA022291 GlaxoSmithKline LLC ELTROMBOPAG OLAMINE 50 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA] N 20181231 0007-4642_c7c46a73-1f77-45f6-ab60-1aa8f9e87463 0007-4642 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20090105 20190331 NDA NDA022291 GlaxoSmithKline LLC ELTROMBOPAG OLAMINE 75 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA] E 20171231 0007-4643_c7c46a73-1f77-45f6-ab60-1aa8f9e87463 0007-4643 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20120102 20190430 NDA NDA022291 GlaxoSmithKline LLC ELTROMBOPAG OLAMINE 12.5 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA] E 20171231 0007-4882_825ef6e8-d41c-440d-93a1-692d9a220376 0007-4882 HUMAN PRESCRIPTION DRUG REQUIP XL ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081120 20201031 NDA NDA022008 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0007-4883_825ef6e8-d41c-440d-93a1-692d9a220376 0007-4883 HUMAN PRESCRIPTION DRUG REQUIP XL ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090803 20201031 NDA NDA022008 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0007-4885_825ef6e8-d41c-440d-93a1-692d9a220376 0007-4885 HUMAN PRESCRIPTION DRUG REQUIP XL ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080630 20190331 NDA NDA022008 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0007-4887_825ef6e8-d41c-440d-93a1-692d9a220376 0007-4887 HUMAN PRESCRIPTION DRUG REQUIP XL ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080630 20200229 NDA NDA022008 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0007-4888_825ef6e8-d41c-440d-93a1-692d9a220376 0007-4888 HUMAN PRESCRIPTION DRUG REQUIP XL ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080630 20200229 NDA NDA022008 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0007-4890_8d8b08db-0c68-4ab1-a2a4-cab804f75438 0007-4890 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971010 20190131 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0007-4891_8d8b08db-0c68-4ab1-a2a4-cab804f75438 0007-4891 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971010 20190731 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0007-4892_8d8b08db-0c68-4ab1-a2a4-cab804f75438 0007-4892 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971001 20190731 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0007-4893_8d8b08db-0c68-4ab1-a2a4-cab804f75438 0007-4893 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971003 20190228 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0007-4894_8d8b08db-0c68-4ab1-a2a4-cab804f75438 0007-4894 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971010 20190331 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0007-4895_8d8b08db-0c68-4ab1-a2a4-cab804f75438 0007-4895 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 20010619 20181031 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0007-4896_8d8b08db-0c68-4ab1-a2a4-cab804f75438 0007-4896 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19990921 20190731 NDA NDA020658 GlaxoSmithKline LLC ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0008-0045_d347a992-be44-4c96-8a13-185a4997d70f 0008-0045 HUMAN PRESCRIPTION DRUG vinorelbine tartrate vinorelbine tartrate INJECTION, SOLUTION INTRAVENOUS 20080213 ANDA ANDA178408 Wyeth Pharmaceuticals Company VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] E 20171231 0008-0100_ee6c1ea5-47ab-478b-996d-461022339832 0008-0100 HUMAN PRESCRIPTION DRUG Besponsa inotuzumab ozogamicin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170818 BLA BLA761040 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. INOTUZUMAB OZOGAMICIN .25 mg/mL CD22-directed Immunoconjugate [EPC],CD22-directed Antibody Interactions [MoA],Decreased DNA Integrity [PE],Increased Cellular Death [PE],Immunoconjugates [Chemical/Ingredient] N 20181231 0008-0423_da5f96b0-5d06-4975-a2db-4e1c989385e0 0008-0423 HUMAN PRESCRIPTION DRUG North American Coral Snake Antivenin (Equine) Coral Snake (Micrurus Fulvius) Immune Globulin Antivenin (Equine) INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20161012 BLA BLA101099 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. CORAL SNAKE (MICRURUS FULVIUS) IMMUNE GLOBULIN ANTIVENIN (EQUINE) 250 [arb'U]/10mL N 20181231 0008-0833_94516864-bc27-4ca5-96f5-ac825a78bd05 0008-0833 HUMAN PRESCRIPTION DRUG Effexor XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0008-0836_94516864-bc27-4ca5-96f5-ac825a78bd05 0008-0836 HUMAN PRESCRIPTION DRUG Effexor XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0008-0837_94516864-bc27-4ca5-96f5-ac825a78bd05 0008-0837 HUMAN PRESCRIPTION DRUG Effexor XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0008-0841_727f0b57-2079-4f9e-9652-6418fe025267 0008-0841 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20000501 NDA NDA020987 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 0008-0843_727f0b57-2079-4f9e-9652-6418fe025267 0008-0843 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20000501 NDA NDA020987 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 0008-0844_727f0b57-2079-4f9e-9652-6418fe025267 0008-0844 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release PANTOPRAZOLE SODIUM GRANULE, DELAYED RELEASE ORAL 20080229 NDA NDA022020 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 0008-0923_db8e6de7-5e85-4e1f-8e3f-733ed8e31cd1 0008-0923 HUMAN PRESCRIPTION DRUG Protonix I.V. PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010501 NDA NDA020988 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 0008-0941_f104247b-cd6e-4f27-b8cc-35b0eaf5b3cc 0008-0941 HUMAN PRESCRIPTION DRUG Protonix I.V. pantoprazole sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010501 NDA NDA020988 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 0008-1030_758437e1-95ba-4e74-a29b-487be7ed3782 0008-1030 HUMAN PRESCRIPTION DRUG Rapamune SIROLIMUS SOLUTION ORAL 19990901 NDA NDA021083 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. SIROLIMUS 1 mg/mL Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0008-1040_758437e1-95ba-4e74-a29b-487be7ed3782 0008-1040 HUMAN PRESCRIPTION DRUG Rapamune SIROLIMUS TABLET, SUGAR COATED ORAL 20100301 NDA NDA021110 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. SIROLIMUS .5 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0008-1041_758437e1-95ba-4e74-a29b-487be7ed3782 0008-1041 HUMAN PRESCRIPTION DRUG Rapamune SIROLIMUS TABLET, SUGAR COATED ORAL 20010701 NDA NDA021110 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. SIROLIMUS 1 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0008-1042_758437e1-95ba-4e74-a29b-487be7ed3782 0008-1042 HUMAN PRESCRIPTION DRUG Rapamune SIROLIMUS TABLET, SUGAR COATED ORAL 20010701 NDA NDA021110 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. SIROLIMUS 2 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0008-1123_604ca3cf-0827-4ad7-94eb-e4d290f957c6 0008-1123 HUMAN PRESCRIPTION DRUG Duavee conjugated estrogens/bazedoxifene TABLET, FILM COATED ORAL 20131003 NDA NDA022247 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED; BAZEDOXIFENE ACETATE .45; 20 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0008-1179_3b4f7783-3213-4fe8-aa59-b244519aee56 0008-1179 HUMAN PRESCRIPTION DRUG Torisel temsirolimus KIT 20070701 NDA NDA022088 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 0008-1210_01a6d79a-ad8a-4d1c-8d01-024630346a76 0008-1210 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20150401 NDA NDA021992 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. DESVENLAFAXINE SUCCINATE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0008-1211_01a6d79a-ad8a-4d1c-8d01-024630346a76 0008-1211 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20080501 NDA NDA021992 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0008-1222_01a6d79a-ad8a-4d1c-8d01-024630346a76 0008-1222 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20080501 NDA NDA021992 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. DESVENLAFAXINE SUCCINATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0008-2001_5c069d3b-0ac7-4d84-ae5c-a3f325719c28 0008-2001 HUMAN PRESCRIPTION DRUG Protonix I.V. PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140317 NDA NDA020988 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 0008-4001_a949c5bc-0517-4013-aba9-54c4c4620c18 0008-4001 HUMAN PRESCRIPTION DRUG Protonix I.V. PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130501 NDA NDA020988 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 0008-4117_b4a80867-83e7-4ce0-8023-4f02c6765b90 0008-4117 HUMAN PRESCRIPTION DRUG Trecator ethionamide TABLET, FILM COATED ORAL 20041108 NDA NDA013026 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ETHIONAMIDE 250 mg/1 Antimycobacterial [EPC] N 20181231 0008-4510_da94b46a-1ee4-476a-bd6f-e60c52918c52 0008-4510 HUMAN PRESCRIPTION DRUG Mylotarg gemtuzumab ozogamicin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170907 BLA BLA761060 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. GEMTUZUMAB OZOGAMICIN 5 mg/5mL CD33-directed Immunoconjugate [EPC],CD33-directed Antibody Interactions [MoA] N 20181231 0008-4990_0129f084-5a59-4282-b27b-3f2dd31381fa 0008-4990 HUMAN PRESCRIPTION DRUG Tygacil TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050601 NDA NDA021821 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TIGECYCLINE 50 mg/5mL Tetracycline-class Antibacterial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0008-4994_10b9af3a-9a50-4cd2-92af-061b0159e9eb 0008-4994 HUMAN PRESCRIPTION DRUG Tygacil TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170208 NDA NDA021821 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TIGECYCLINE 50 mg/5mL Tetracycline-class Antibacterial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0009-0003_9f108946-8e00-4570-8335-2b6de7251a55 0009-0003 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE SODIUM SUCCINATE 500 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0005_4644d33c-93fd-4d77-b8d2-bb586f616c98 0009-0005 HUMAN PRESCRIPTION DRUG Solu-Cortef hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19550427 NDA NDA009866 Pharmacia and Upjohn Company LLC HYDROCORTISONE SODIUM SUCCINATE 1000 mg/8mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0011_4644d33c-93fd-4d77-b8d2-bb586f616c98 0009-0011 HUMAN PRESCRIPTION DRUG Solu-Cortef hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19550427 NDA NDA009866 Pharmacia and Upjohn Company LLC HYDROCORTISONE SODIUM SUCCINATE 100 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0012_dc373892-bb58-40c2-a2fd-0b6a90f6cf49 0009-0012 HUMAN PRESCRIPTION DRUG CORTEF hydrocortisone TABLET ORAL 19521215 NDA NDA008697 Pharmacia and Upjohn Company LLC HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0013_4644d33c-93fd-4d77-b8d2-bb586f616c98 0009-0013 HUMAN PRESCRIPTION DRUG Solu-Cortef hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19550427 NDA NDA009866 Pharmacia and Upjohn Company LLC HYDROCORTISONE SODIUM SUCCINATE 250 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0016_4644d33c-93fd-4d77-b8d2-bb586f616c98 0009-0016 HUMAN PRESCRIPTION DRUG Solu-Cortef hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19550427 NDA NDA009866 Pharmacia and Upjohn Company LLC HYDROCORTISONE SODIUM SUCCINATE 500 mg/4mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0017_63e93c08-0f2d-4a36-9fd7-d61c33a1baf2 0009-0017 HUMAN PRESCRIPTION DRUG Halcion triazolam TABLET ORAL 19821115 NDA NDA017892 Pharmacia and Upjohn Company LLC TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0009-0018_9f108946-8e00-4570-8335-2b6de7251a55 0009-0018 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE SODIUM SUCCINATE 1 g/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0020_d34ca106-6733-4cf8-b50e-69095748d4d1 0009-0020 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 20130920 NDA NDA011153 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-0022_d34ca106-6733-4cf8-b50e-69095748d4d1 0009-0022 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 19571024 NDA NDA011153 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE 8 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-0029_afc4f1e9-2318-41e3-aa36-91e5da3d62d2 0009-0029 HUMAN PRESCRIPTION DRUG Xanax alprazolam TABLET ORAL 19811016 NDA NDA018276 Pharmacia and Upjohn Company LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0009-0031_dc373892-bb58-40c2-a2fd-0b6a90f6cf49 0009-0031 HUMAN PRESCRIPTION DRUG CORTEF hydrocortisone TABLET ORAL 19521215 NDA NDA008697 Pharmacia and Upjohn Company LLC HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0039_8ef4f66d-93a0-48b6-9320-552feee0a9ae 0009-0039 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0039_9f108946-8e00-4570-8335-2b6de7251a55 0009-0039 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0044_dc373892-bb58-40c2-a2fd-0b6a90f6cf49 0009-0044 HUMAN PRESCRIPTION DRUG CORTEF hydrocortisone TABLET ORAL 19521215 NDA NDA008697 Pharmacia and Upjohn Company LLC HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0047_9f108946-8e00-4570-8335-2b6de7251a55 0009-0047 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0050_8e280ce3-d109-4622-a824-d8bbaa045147 0009-0050 HUMAN PRESCRIPTION DRUG Provera medroxyprogesterone acetate TABLET ORAL 19590603 NDA NDA011839 Pharmacia and Upjohn Company LLC MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0009-0055_afc4f1e9-2318-41e3-aa36-91e5da3d62d2 0009-0055 HUMAN PRESCRIPTION DRUG Xanax alprazolam TABLET ORAL 19811016 NDA NDA018276 Pharmacia and Upjohn Company LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0009-0056_d34ca106-6733-4cf8-b50e-69095748d4d1 0009-0056 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 19571024 NDA NDA011153 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-0057_b2692032-029d-4725-a3d2-6ed4b06aaefa 0009-0057 HUMAN PRESCRIPTION DRUG Xanax XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA NDA021434 Pharmacia and Upjohn Company LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0009-0059_b2692032-029d-4725-a3d2-6ed4b06aaefa 0009-0059 HUMAN PRESCRIPTION DRUG Xanax XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA NDA021434 Pharmacia and Upjohn Company LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0009-0064_8e280ce3-d109-4622-a824-d8bbaa045147 0009-0064 HUMAN PRESCRIPTION DRUG Provera medroxyprogesterone acetate TABLET ORAL 19590603 NDA NDA011839 Pharmacia and Upjohn Company LLC MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0009-0066_b2692032-029d-4725-a3d2-6ed4b06aaefa 0009-0066 HUMAN PRESCRIPTION DRUG Xanax XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA NDA021434 Pharmacia and Upjohn Company LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0009-0068_b2692032-029d-4725-a3d2-6ed4b06aaefa 0009-0068 HUMAN PRESCRIPTION DRUG Xanax XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA NDA021434 Pharmacia and Upjohn Company LLC ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0009-0073_d34ca106-6733-4cf8-b50e-69095748d4d1 0009-0073 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 19571024 NDA NDA011153 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE 16 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-0085_9553c640-2c3c-4968-a058-94731bae1d72 0009-0085 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 20140701 ANDA ANDA085635 Pharmacia and Upjohn Company LLC TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0009-0086_9553c640-2c3c-4968-a058-94731bae1d72 0009-0086 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 20140701 ANDA ANDA085635 Pharmacia and Upjohn Company LLC TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0009-0090_afc4f1e9-2318-41e3-aa36-91e5da3d62d2 0009-0090 HUMAN PRESCRIPTION DRUG Xanax alprazolam TABLET ORAL 19811016 NDA NDA018276 Pharmacia and Upjohn Company LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0009-0094_afc4f1e9-2318-41e3-aa36-91e5da3d62d2 0009-0094 HUMAN PRESCRIPTION DRUG Xanax alprazolam TABLET ORAL 19811016 NDA NDA018276 Pharmacia and Upjohn Company LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0009-0176_d34ca106-6733-4cf8-b50e-69095748d4d1 0009-0176 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 19571024 NDA NDA011153 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE 32 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-0225_3bf6ffb7-bf53-4235-b0cf-e1f3f57665ee 0009-0225 HUMAN PRESCRIPTION DRUG Cleocin Hydrochloride clindamycin hydrochloride CAPSULE ORAL 19700522 NDA NDA050162 Pharmacia and Upjohn Company LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-0233_a0593b12-3a06-4043-b533-223e9c001392 0009-0233 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 19480729 ANDA ANDA060733 Pharmacia and Upjohn Company LLC BACITRACIN A 5000 [USP'U]/mL N 20181231 0009-0233_fdafa7dd-f9e7-47d4-b2d9-054d9fcc861e 0009-0233 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 19480729 ANDA ANDA060733 Pharmacia and Upjohn Company LLC BACITRACIN 5000 [USP'U]/mL Decreased Cell Wall Synthesis & Repair [PE] N 20181231 0009-0234_5aed9542-6254-460a-a461-2b324a775cbd 0009-0234 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 19480729 ANDA ANDA060733 Pharmacia and Upjohn Company LLC BACITRACIN 5000 [USP'U]/mL Decreased Cell Wall Synthesis & Repair [PE] N 20181231 0009-0241_d82a009a-6e8d-4469-99c0-9cb2b84f8421 0009-0241 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 19480729 ANDA ANDA060733 Pharmacia and Upjohn Company LLC BACITRACIN A 5000 [USP'U]/mL N 20181231 0009-0260_a7effc61-c146-43e2-89ce-297c211a7975 0009-0260 HUMAN PRESCRIPTION DRUG Colestid Colestipol Hydrochloride GRANULE, FOR SUSPENSION ORAL 19770404 NDA NDA017563 Pharmacia and Upjohn Company LLC COLESTIPOL HYDROCHLORIDE 5 g/5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 0009-0271_2ac78160-8006-40b3-9635-59c6d008a4ec 0009-0271 HUMAN PRESCRIPTION DRUG Depo-Estradiol estradiol cypionate INJECTION INTRAMUSCULAR 19790815 ANDA ANDA085470 Pharmacia and Upjohn Company LLC ESTRADIOL CYPIONATE 5 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0009-0274_d46a0b44-8456-4bb0-b27a-0f5563ad231b 0009-0274 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE ACETATE 20 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-0280_d46a0b44-8456-4bb0-b27a-0f5563ad231b 0009-0280 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-0280_d5c7d140-4ca4-4f25-ab21-1cb2ef2ab226 0009-0280 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-0286_8e280ce3-d109-4622-a824-d8bbaa045147 0009-0286 HUMAN PRESCRIPTION DRUG Provera medroxyprogesterone acetate TABLET ORAL 19590603 NDA NDA011839 Pharmacia and Upjohn Company LLC MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0009-0302_77a7e203-b1d1-4ae4-b340-a0f7cadbcee8 0009-0302 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140410 NDA NDA050441 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-0306_d46a0b44-8456-4bb0-b27a-0f5563ad231b 0009-0306 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-0306_d5c7d140-4ca4-4f25-ab21-1cb2ef2ab226 0009-0306 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-0331_3bf6ffb7-bf53-4235-b0cf-e1f3f57665ee 0009-0331 HUMAN PRESCRIPTION DRUG Cleocin Hydrochloride clindamycin hydrochloride CAPSULE ORAL 19700522 NDA NDA050162 Pharmacia and Upjohn Company LLC CLINDAMYCIN HYDROCHLORIDE 75 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-0341_03bce5d4-2e0d-41c5-8048-ceb4749b0b5a 0009-0341 HUMAN PRESCRIPTION DRUG Glynase glyburide TABLET ORAL 19920304 NDA NDA020051 Pharmacia and Upjohn Company LLC GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0009-0347_2c73df83-5a0f-4e61-88e0-9393d6741daf 0009-0347 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 19790725 ANDA ANDA085635 Pharmacia and Upjohn Company LLC TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0009-0352_03bce5d4-2e0d-41c5-8048-ceb4749b0b5a 0009-0352 HUMAN PRESCRIPTION DRUG Glynase glyburide TABLET ORAL 19920304 NDA NDA020051 Pharmacia and Upjohn Company LLC GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0009-0370_a7effc61-c146-43e2-89ce-297c211a7975 0009-0370 HUMAN PRESCRIPTION DRUG Flavored Colestid Colestipol Hydrochloride GRANULE, FOR SUSPENSION ORAL 19770404 NDA NDA017563 Pharmacia and Upjohn Company LLC COLESTIPOL HYDROCHLORIDE 5 g/7.5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 0009-0395_3bf6ffb7-bf53-4235-b0cf-e1f3f57665ee 0009-0395 HUMAN PRESCRIPTION DRUG Cleocin Hydrochloride clindamycin hydrochloride CAPSULE ORAL 19700522 NDA NDA050162 Pharmacia and Upjohn Company LLC CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-0417_2c73df83-5a0f-4e61-88e0-9393d6741daf 0009-0417 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 19790725 ANDA ANDA085635 Pharmacia and Upjohn Company LLC TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0009-0436_6acdd918-6c3b-4eb8-93f4-dafb72e47c76 0009-0436 HUMAN PRESCRIPTION DRUG R-Gene Arginine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19760615 NDA NDA016931 Pharmacia and Upjohn Company LLC ARGININE HYDROCHLORIDE 10 g/100mL N 20181231 0009-0450_c01764bb-6f06-4935-bb33-9cdad812d4c5 0009-0450 HUMAN PRESCRIPTION DRUG Colestid Colestipol Hydrochloride TABLET ORAL 19940719 NDA NDA020222 Pharmacia and Upjohn Company LLC COLESTIPOL HYDROCHLORIDE 1 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 0009-0520_5b1e5c9e-f5e4-4d33-ac98-5fed841aa676 0009-0520 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 20140331 ANDA ANDA085635 Pharmacia and Upjohn Company LLC TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0009-0555_55529020-c122-4964-92f9-5dfdb074d3ec 0009-0555 HUMAN PRESCRIPTION DRUG Lincocin lincomycin hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL 19641229 NDA NDA050317 Pharmacia and Upjohn Company LLC LINCOMYCIN HYDROCHLORIDE 300 mg/mL N 20181231 0009-0602_77a7e203-b1d1-4ae4-b340-a0f7cadbcee8 0009-0602 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140410 NDA NDA050441 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-0626_4afa2a80-deb9-4452-bae9-10d76fe83e94 0009-0626 HUMAN PRESCRIPTION DRUG Depo-Provera medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19601101 NDA NDA012541 Pharmacia and Upjohn Company LLC MEDROXYPROGESTERONE ACETATE 400 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0009-0698_9f108946-8e00-4570-8335-2b6de7251a55 0009-0698 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE SODIUM SUCCINATE 1 g/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0728_0584d8a1-1d37-4ad8-bdd9-11ed99fb0291 0009-0728 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19721002 NDA NDA050441 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-0746_507f16c7-aa8f-42ec-aeca-ffe853f4cc06 0009-0746 HUMAN PRESCRIPTION DRUG Depo-Provera medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA NDA020246 Pharmacia and Upjohn Company LLC MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0009-0758_9f108946-8e00-4570-8335-2b6de7251a55 0009-0758 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE SODIUM SUCCINATE 500 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0760_8e11daed-0f2a-4cd5-9f38-99a6c8f8a6d1 0009-0760 HUMAN PRESCRIPTION DRUG Cleocin Pediatric clindamycin palmitate hydrochloride GRANULE, FOR SOLUTION ORAL 19860417 ANDA ANDA062644 Pharmacia and Upjohn Company LLC CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-0775_0584d8a1-1d37-4ad8-bdd9-11ed99fb0291 0009-0775 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19721002 NDA NDA050441 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-0796_9f108946-8e00-4570-8335-2b6de7251a55 0009-0796 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate KIT 19590402 NDA NDA011856 Pharmacia and Upjohn Company LLC N 20181231 0009-0825_4644d33c-93fd-4d77-b8d2-bb586f616c98 0009-0825 HUMAN PRESCRIPTION DRUG Solu-Cortef hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19550427 NDA NDA009866 Pharmacia and Upjohn Company LLC HYDROCORTISONE SODIUM SUCCINATE 100 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0009-0827_a75c4d74-e942-4558-9c88-5e828c0f1f68 0009-0827 HUMAN PRESCRIPTION DRUG Prostin E2 dinoprostone SUPPOSITORY VAGINAL 19780118 NDA NDA017810 Pharmacia and Upjohn Company LLC DINOPROSTONE 20 mg/1 Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 0009-0856_0eeee18d-dfa0-4780-97a8-71fa2daf6a74 0009-0856 HUMAN PRESCRIPTION DRUG Hemabate carboprost tromethamine INJECTION, SOLUTION INTRAMUSCULAR 19790109 NDA NDA017989 Pharmacia and Upjohn Company LLC CARBOPROST TROMETHAMINE 250 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20191231 0009-0870_0584d8a1-1d37-4ad8-bdd9-11ed99fb0291 0009-0870 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19721002 NDA NDA050441 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-0901_77a7e203-b1d1-4ae4-b340-a0f7cadbcee8 0009-0901 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140410 NDA NDA050441 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-0902_0584d8a1-1d37-4ad8-bdd9-11ed99fb0291 0009-0902 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19721002 NDA NDA050441 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-1111_cb14c587-e1ba-4cb5-b555-93becd6ce8d8 0009-1111 HUMAN PRESCRIPTION DRUG Camptosar irinotecan hydrochloride INJECTION, SOLUTION INTRAVENOUS 19960614 NDA NDA020571 Pharmacia and Upjohn Company LLC IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0009-3073_ef240a4d-6ebb-4d79-933d-0ac0280a945d 0009-3073 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-3073_ffa95a94-400d-44cb-bff2-bae6059c5288 0009-3073 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-3116_9d8ce845-6f00-4ada-a3ea-451d1b74f441 0009-3116 HUMAN PRESCRIPTION DRUG Cleocin T clindamycin phosphate SOLUTION TOPICAL 19800620 NDA NDA050537 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-3124_0584d8a1-1d37-4ad8-bdd9-11ed99fb0291 0009-3124 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 19871016 ANDA ANDA062803 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-3169_fc8f9f72-2bfe-4926-8dd7-690e89dd9f0b 0009-3169 HUMAN PRESCRIPTION DRUG PROSTIN VR PEDIATRIC alprostadil INJECTION, SOLUTION INTRAVASCULAR; INTRAVENOUS 19811016 NDA NDA018484 Pharmacia and Upjohn Company LLC ALPROSTADIL 500 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 0009-3329_9d8ce845-6f00-4ada-a3ea-451d1b74f441 0009-3329 HUMAN PRESCRIPTION DRUG Cleocin T clindamycin phosphate LOTION TOPICAL 19890531 NDA NDA050600 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-3331_9d8ce845-6f00-4ada-a3ea-451d1b74f441 0009-3331 HUMAN PRESCRIPTION DRUG Cleocin T clindamycin phosphate GEL TOPICAL 19870107 NDA NDA050615 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-3359_a8b3b500-a272-44bb-8eed-8f825a076573 0009-3359 HUMAN PRESCRIPTION DRUG Prepidil dinoprostone GEL VAGINAL 19921209 NDA NDA019617 Pharmacia and Upjohn Company LLC DINOPROSTONE .5 mg/3g Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 0009-3375_0584d8a1-1d37-4ad8-bdd9-11ed99fb0291 0009-3375 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 19900830 NDA NDA050639 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 12 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-3381_0584d8a1-1d37-4ad8-bdd9-11ed99fb0291 0009-3381 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 19900830 NDA NDA050639 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 6 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-3382_0584d8a1-1d37-4ad8-bdd9-11ed99fb0291 0009-3382 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 19900830 NDA NDA050639 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 18 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-3447_0584d8a1-1d37-4ad8-bdd9-11ed99fb0291 0009-3447 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 19871016 ANDA ANDA062803 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-3448_6939ae7f-522a-45ea-8f22-efd094973b77 0009-3448 HUMAN PRESCRIPTION DRUG Cleocin clindamycin phosphate CREAM VAGINAL 19920811 NDA NDA050680 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-3449_03bce5d4-2e0d-41c5-8048-ceb4749b0b5a 0009-3449 HUMAN PRESCRIPTION DRUG Glynase glyburide TABLET ORAL 19920304 NDA NDA020051 Pharmacia and Upjohn Company LLC GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0009-3470_77a7e203-b1d1-4ae4-b340-a0f7cadbcee8 0009-3470 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140926 NDA NDA050639 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 6 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-3475_ef240a4d-6ebb-4d79-933d-0ac0280a945d 0009-3475 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-3475_ffa95a94-400d-44cb-bff2-bae6059c5288 0009-3475 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Pharmacia and Upjohn Company LLC METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0009-3701_29d5b119-e3f3-4246-b01e-8aa7217785fe 0009-3701 HUMAN PRESCRIPTION DRUG Caverject Alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 19950706 NDA NDA020379 Pharmacia and Upjohn Company LLC ALPROSTADIL 20.5 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20191231 0009-3794_1e246a71-3d4e-4737-bf9b-5a53e1772b49 0009-3794 HUMAN PRESCRIPTION DRUG Corvert ibutilide fumarate INJECTION, SOLUTION INTRAVENOUS 19951228 NDA NDA020491 Pharmacia and Upjohn Company LLC IBUTILIDE FUMARATE .1 mg/mL Antiarrhythmic [EPC] N 20191231 0009-3794_387c1cc9-4afc-4a1a-82e4-cd0fb535a82c 0009-3794 HUMAN PRESCRIPTION DRUG Corvert ibutilide fumarate INJECTION, SOLUTION INTRAVENOUS 19951228 NDA NDA020491 Pharmacia and Upjohn Company LLC IBUTILIDE FUMARATE .1 mg/mL Antiarrhythmic [EPC] N 20191231 0009-4541_c3566921-d549-46b6-b227-a72daaf73ad6 0009-4541 HUMAN PRESCRIPTION DRUG Detrol tolterodine tartrate TABLET, FILM COATED ORAL 19980325 NDA NDA020771 Pharmacia and Upjohn Company LLC TOLTERODINE TARTRATE 1 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0009-4544_c3566921-d549-46b6-b227-a72daaf73ad6 0009-4544 HUMAN PRESCRIPTION DRUG Detrol tolterodine tartrate TABLET, FILM COATED ORAL 19980325 NDA NDA020771 Pharmacia and Upjohn Company LLC TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0009-4709_2219a0ef-8b1c-48f8-947b-3be2798a6314 0009-4709 HUMAN PRESCRIPTION DRUG Depo-SubQ Provera medroxyprogesterone acetate INJECTION, SUSPENSION SUBCUTANEOUS 20050502 NDA NDA021583 Pharmacia and Upjohn Company LLC MEDROXYPROGESTERONE ACETATE 104 mg/.65mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0009-4992_9beec729-f804-48e5-a137-19ca7d90d6a0 0009-4992 HUMAN PRESCRIPTION DRUG Zyvox linezolid INJECTION, SOLUTION INTRAVENOUS 20150706 NDA NDA021131 Pharmacia and Upjohn Company LINEZOLID 600 mg/300mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0009-5012_fe4b4aa6-600c-4715-a70d-1ed12e83f1f3 0009-5012 HUMAN PRESCRIPTION DRUG Glyset miglitol TABLET, FILM COATED ORAL 19961218 NDA NDA020682 Pharmacia and Upjohn Company LLC MIGLITOL 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 0009-5013_fe4b4aa6-600c-4715-a70d-1ed12e83f1f3 0009-5013 HUMAN PRESCRIPTION DRUG Glyset miglitol TABLET, FILM COATED ORAL 19961218 NDA NDA020682 Pharmacia and Upjohn Company LLC MIGLITOL 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 0009-5014_fe4b4aa6-600c-4715-a70d-1ed12e83f1f3 0009-5014 HUMAN PRESCRIPTION DRUG Glyset miglitol TABLET, FILM COATED ORAL 19961218 NDA NDA020682 Pharmacia and Upjohn Company LLC MIGLITOL 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 0009-5091_08349a5c-06af-4042-85cd-62d3f186d70a 0009-5091 HUMAN PRESCRIPTION DRUG Ellence epirubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19990915 NDA NDA050778 Pharmacia and Upjohn Company LLC EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0009-5093_08349a5c-06af-4042-85cd-62d3f186d70a 0009-5093 HUMAN PRESCRIPTION DRUG Ellence epirubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19990915 NDA NDA050778 Pharmacia and Upjohn Company LLC EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0009-5135_0d3beef0-3415-4b87-a821-3f7358c267b9 0009-5135 HUMAN PRESCRIPTION DRUG Zyvox linezolid TABLET, FILM COATED ORAL 20000418 NDA NDA021130 Pharmacia and Upjohn Company LLC LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0009-5136_0d3beef0-3415-4b87-a821-3f7358c267b9 0009-5136 HUMAN PRESCRIPTION DRUG Zyvox linezolid SUSPENSION ORAL 20000418 NDA NDA021132 Pharmacia and Upjohn Company LLC LINEZOLID 100 mg/5mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0009-5137_0d3beef0-3415-4b87-a821-3f7358c267b9 0009-5137 HUMAN PRESCRIPTION DRUG Zyvox linezolid INJECTION, SOLUTION INTRAVENOUS 20000418 NDA NDA021131 Pharmacia and Upjohn Company LLC LINEZOLID 200 mg/100mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0009-5138_0d3beef0-3415-4b87-a821-3f7358c267b9 0009-5138 HUMAN PRESCRIPTION DRUG Zyvox linezolid TABLET, FILM COATED ORAL 20151012 NDA NDA021130 Pharmacia and Upjohn Company LLC LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0009-5139_0d3beef0-3415-4b87-a821-3f7358c267b9 0009-5139 HUMAN PRESCRIPTION DRUG Zyvox linezolid INJECTION, SOLUTION INTRAVENOUS 20000418 NDA NDA021131 Pharmacia and Upjohn Company LLC LINEZOLID 400 mg/200mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0009-5140_0d3beef0-3415-4b87-a821-3f7358c267b9 0009-5140 HUMAN PRESCRIPTION DRUG Zyvox linezolid INJECTION, SOLUTION INTRAVENOUS 20000418 NDA NDA021131 Pharmacia and Upjohn Company LLC LINEZOLID 600 mg/300mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0009-5176_1b61712a-f635-4cab-b80e-17396ca4cb4f 0009-5176 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20030525 NDA NDA021106 Pharmacia and Upjohn Company LLC N 20181231 0009-5178_1b61712a-f635-4cab-b80e-17396ca4cb4f 0009-5178 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20030525 NDA NDA021106 Pharmacia and Upjohn Company LLC N 20181231 0009-5180_1b61712a-f635-4cab-b80e-17396ca4cb4f 0009-5180 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20030525 NDA NDA021106 Pharmacia and Upjohn Company LLC N 20181231 0009-5181_85f88e7f-2a54-42d2-ae5d-0969374b7ed4 0009-5181 HUMAN PRESCRIPTION DRUG Caverject Impulse Alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20020611 NDA NDA021212 Pharmacia and Upjohn Company LLC ALPROSTADIL 10 ug/.5mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 0009-5182_85f88e7f-2a54-42d2-ae5d-0969374b7ed4 0009-5182 HUMAN PRESCRIPTION DRUG Caverject Impulse Alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20020611 NDA NDA021212 Pharmacia and Upjohn Company LLC ALPROSTADIL 20 ug/.5mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 0009-5190_1f83c1a9-16b7-448f-a004-bf1b52b5e029 0009-5190 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20000222 NDA NDA021228 Pharmacia and Upjohn Company LLC TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0009-5191_1f83c1a9-16b7-448f-a004-bf1b52b5e029 0009-5191 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20000222 NDA NDA021228 Pharmacia and Upjohn Company LLC TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0009-5199_1b61712a-f635-4cab-b80e-17396ca4cb4f 0009-5199 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20140731 NDA NDA021106 Pharmacia and Upjohn Company LLC N 20181231 0009-5200_1b61712a-f635-4cab-b80e-17396ca4cb4f 0009-5200 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20140731 NDA NDA021106 Pharmacia and Upjohn Company LLC N 20181231 0009-5400_15c8d5ef-66cc-4845-b598-2d8667a43f33 0009-5400 HUMAN PRESCRIPTION DRUG Nicotrol nicotine INHALANT RESPIRATORY (INHALATION) 19970502 NDA NDA020714 Pharmacia and Upjohn Company LLC NICOTINE 4 mg/1 Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] N 20181231 0009-5401_fa35156d-32d3-4eec-ac89-96bc762c6fd9 0009-5401 HUMAN PRESCRIPTION DRUG Nicotrol nicotine SPRAY, METERED NASAL 19960522 NDA NDA020385 Pharmacia and Upjohn Company LLC NICOTINE 10 mg/mL Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] N 20181231 0009-6582_0584d8a1-1d37-4ad8-bdd9-11ed99fb0291 0009-6582 HUMAN PRESCRIPTION DRUG Cleocin Phosphate (0009-6582) (Standalone) clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 19871016 ANDA ANDA062803 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-6780_77a7e203-b1d1-4ae4-b340-a0f7cadbcee8 0009-6780 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140926 NDA NDA050639 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 12 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-7166_b9915d75-15eb-499a-85eb-a3ee5d4b2131 0009-7166 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20161001 NDA NDA021106 Pharmacia and Upjohn Company LLC N 20181231 0009-7168_b9915d75-15eb-499a-85eb-a3ee5d4b2131 0009-7168 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20161001 NDA NDA021106 Pharmacia and Upjohn Company LLC N 20181231 0009-7188_b9915d75-15eb-499a-85eb-a3ee5d4b2131 0009-7188 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20161001 NDA NDA021106 Pharmacia and Upjohn Company LLC N 20181231 0009-7199_b9915d75-15eb-499a-85eb-a3ee5d4b2131 0009-7199 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20161001 NDA NDA021106 Pharmacia and Upjohn Company LLC N 20181231 0009-7200_b9915d75-15eb-499a-85eb-a3ee5d4b2131 0009-7200 HUMAN PRESCRIPTION DRUG SOMAVERT pegvisomant KIT 20161001 NDA NDA021106 Pharmacia and Upjohn Company LLC N 20181231 0009-7224_a3d8c75d-5661-4919-b664-3e42f69eda00 0009-7224 PLASMA DERIVATIVE Atgam EQUINE THYMOCYTE IMMUNE GLOBULIN INJECTION, SOLUTION INTRAVENOUS 19811117 BLA BLA103676 Pharmacia and Upjohn Company LLC EQUINE THYMOCYTE IMMUNE GLOBULIN 50 mg/mL Immunoglobulin G [EPC],Lymphocyte Function Alteration [PE],Increased T Lymphocyte Destruction [PE],Antibody-Surface Protein Interactions [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 0009-7376_507f16c7-aa8f-42ec-aeca-ffe853f4cc06 0009-7376 HUMAN PRESCRIPTION DRUG Depo-Provera medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA NDA020246 Pharmacia and Upjohn Company LLC MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0009-7529_d3019f01-037e-4812-b0a9-19f7cfa014ca 0009-7529 HUMAN PRESCRIPTION DRUG Camptosar irinotecan hydrochloride INJECTION, SOLUTION INTRAVENOUS 19960614 NDA NDA020571 Pharmacia and Upjohn Company LLC IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0009-7663_bf595fdf-018a-465c-b957-096633b6f8bf 0009-7663 HUMAN PRESCRIPTION DRUG Aromasin exemestane TABLET ORAL 19991021 NDA NDA020753 Pharmacia and Upjohn Company LLC EXEMESTANE 25 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0009-7667_266e7858-a666-43bb-a090-849970287713 0009-7667 HUMAN PRESCRIPTION DRUG Cleocin clindamycin phosphate SUPPOSITORY VAGINAL 19990813 NDA NDA050767 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 100 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0009-7686_29d5b119-e3f3-4246-b01e-8aa7217785fe 0009-7686 HUMAN PRESCRIPTION DRUG Caverject Alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 19950706 NDA NDA020379 Pharmacia and Upjohn Company LLC ALPROSTADIL 41.1 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20191231 0009-7807_4ee972e0-6abe-4536-87a2-69d58c3e6384 0009-7807 HUMAN PRESCRIPTION DRUG Zyvox linezolid INJECTION, SOLUTION INTRAVENOUS 20150218 NDA NDA021131 Pharmacia and Upjohn Company LLC LINEZOLID 600 mg/300mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0009-9890_77a7e203-b1d1-4ae4-b340-a0f7cadbcee8 0009-9890 HUMAN PRESCRIPTION DRUG Cleocin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140926 NDA NDA050639 Pharmacia and Upjohn Company LLC CLINDAMYCIN PHOSPHATE 18 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0013-0101_8500bcff-4683-44f9-aed0-257e9451a5fd 0013-0101 HUMAN PRESCRIPTION DRUG Azulfidine Sulfasalazine TABLET ORAL 19500620 NDA NDA007073 Pharmacia and Upjohn Company LLC SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0013-0102_19030cfc-9aec-4ffa-bccc-3220a0767056 0013-0102 HUMAN PRESCRIPTION DRUG Azulfidine EN-tabs Sulfasalazine TABLET, DELAYED RELEASE ORAL 19500620 NDA NDA007073 Pharmacia and Upjohn Company LLC SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0013-0132_89ad27c2-a441-4607-9356-3bcf7c015368 0013-0132 HUMAN PRESCRIPTION DRUG Emcyt estramustine phosphate sodium CAPSULE ORAL 19920101 NDA NDA018045 Pharmacia and Upjohn Company LLC ESTRAMUSTINE PHOSPHATE SODIUM 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC],Estradiol [Chemical/Ingredient],Nitrogen Mustard Compounds [Chemical/Ingredient] N 20181231 0013-1114_abcd2611-4332-42a5-b41e-878387d12ed7 0013-1114 HUMAN PRESCRIPTION DRUG Cyklokapron tranexamic acid INJECTION, SOLUTION INTRAVENOUS 19861230 NDA NDA019281 Pharmacia and Upjohn Company LLC TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 0013-2150_2885948b-3daf-4d27-8d27-196ce7474294 0013-2150 HUMAN PRESCRIPTION DRUG Estring estradiol RING VAGINAL 19960426 NDA NDA020472 Pharmacia and Upjohn Company LLC ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0013-2576_d15f2f64-0955-42cb-9203-2cf11692011d 0013-2576 HUMAN PRESCRIPTION DRUG Idamycin PFS idarubicin hydrochloride SOLUTION INTRAVENOUS 19970217 NDA NDA050734 Pharmacia and Upjohn Company LLC IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0013-2586_d15f2f64-0955-42cb-9203-2cf11692011d 0013-2586 HUMAN PRESCRIPTION DRUG Idamycin PFS idarubicin hydrochloride SOLUTION INTRAVENOUS 19970217 NDA NDA050734 Pharmacia and Upjohn Company LLC IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0013-2596_d15f2f64-0955-42cb-9203-2cf11692011d 0013-2596 HUMAN PRESCRIPTION DRUG Idamycin PFS idarubicin hydrochloride SOLUTION INTRAVENOUS 19970217 NDA NDA050734 Pharmacia and Upjohn Company LLC IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0013-2626_dfe97f6c-4d01-45bd-b292-8dc923969c8a 0013-2626 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company LLC N 20181231 0013-2646_dfe97f6c-4d01-45bd-b292-8dc923969c8a 0013-2646 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company LLC N 20181231 0013-2649_dfe97f6c-4d01-45bd-b292-8dc923969c8a 0013-2649 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company LLC N 20181231 0013-2650_dfe97f6c-4d01-45bd-b292-8dc923969c8a 0013-2650 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company LLC N 20181231 0013-2651_dfe97f6c-4d01-45bd-b292-8dc923969c8a 0013-2651 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company LLC N 20181231 0013-2652_dfe97f6c-4d01-45bd-b292-8dc923969c8a 0013-2652 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company LLC N 20181231 0013-2653_dfe97f6c-4d01-45bd-b292-8dc923969c8a 0013-2653 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company LLC N 20181231 0013-2654_dfe97f6c-4d01-45bd-b292-8dc923969c8a 0013-2654 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company LLC N 20181231 0013-2655_dfe97f6c-4d01-45bd-b292-8dc923969c8a 0013-2655 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company LLC N 20181231 0013-2656_dfe97f6c-4d01-45bd-b292-8dc923969c8a 0013-2656 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company LLC N 20181231 0013-2657_dfe97f6c-4d01-45bd-b292-8dc923969c8a 0013-2657 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company LLC N 20181231 0013-2658_dfe97f6c-4d01-45bd-b292-8dc923969c8a 0013-2658 HUMAN PRESCRIPTION DRUG GENOTROPIN somatropin KIT 19951220 NDA NDA020280 Pharmacia and Upjohn Company LLC N 20181231 0013-5301_a366a797-80d0-4e48-8901-116d62ed6d2c 0013-5301 HUMAN PRESCRIPTION DRUG Mycobutin rifabutin CAPSULE ORAL 19921223 NDA NDA050689 Pharmacia and Upjohn Company LLC RIFABUTIN 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 0013-8303_341a853e-1bd6-4ba0-a851-5ee05c2024e0 0013-8303 HUMAN PRESCRIPTION DRUG Xalatan latanoprost SOLUTION OPHTHALMIC 19950320 NDA NDA020597 Pharmacia and Upjohn Company LLC LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 0013-8717_464537a7-86e4-436a-aa6e-696402312ee1 0013-8717 HUMAN PRESCRIPTION DRUG Zinecard dexrazoxane INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19950526 NDA NDA020212 Pharmacia and Upjohn Company LLC DEXRAZOXANE HYDROCHLORIDE 250 mg/25mL Cytoprotective Agent [EPC] N 20181231 0013-8727_464537a7-86e4-436a-aa6e-696402312ee1 0013-8727 HUMAN PRESCRIPTION DRUG Zinecard dexrazoxane INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19950526 NDA NDA020212 Pharmacia and Upjohn Company LLC DEXRAZOXANE HYDROCHLORIDE 500 mg/50mL Cytoprotective Agent [EPC] N 20181231 0015-0508_66fcd921-f182-4992-9f62-f9f1a839299c 0015-0508 HUMAN PRESCRIPTION DRUG MEGACE MEGESTROL ACETATE SUSPENSION ORAL 20090601 20190331 NDA NDA020264 E.R. Squibb & Sons, L.L.C. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0015-3080_f7300281-bca8-4dba-ba90-258712a76093 0015-3080 HUMAN PRESCRIPTION DRUG LYSODREN MITOTANE TABLET ORAL 20090601 NDA NDA016885 E.R. Squibb & Sons, L.L.C. MITOTANE 500 mg/1 Cytochrome P450 3A4 Inducers [MoA] N 20181231 0015-3404_313e8121-bbc5-4317-8e2e-c3a5b1a86996 0015-3404 HUMAN PRESCRIPTION DRUG ETOPOPHOS etoposide phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090601 NDA NDA020457 E.R. Squibb & Sons, L.L.C. ETOPOSIDE PHOSPHATE 100 mg/1 Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0019-0862_dd585c37-4a03-4158-9217-40a8ca4544db 0019-0862 HUMAN PRESCRIPTION DRUG Cysto-Conray II Iothalamate meglumine INJECTION URETERAL 20101008 NDA NDA017057 Liebel-Flarsheim Company LLC IOTHALAMATE MEGLUMINE 172 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0019-0952_e80407fa-3e59-461f-a0ab-c30384294c58 0019-0952 HUMAN PRESCRIPTION DRUG Conray 30 Iothalamate Meglumine INJECTION INTRAVASCULAR 20120326 NDA NDA016983 Liebel-Flarsheim Company LLC IOTHALAMATE MEGLUMINE 300 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0019-0953_2e644c0b-a56c-4759-9376-fc25f6a1cea0 0019-0953 HUMAN PRESCRIPTION DRUG Conray iothalamate meglumine INJECTION INTRAVASCULAR 20031014 NDA NDA013295 Liebel-Flarsheim Company LLC IOTHALAMATE MEGLUMINE 600 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0019-1177_35c3b4f7-803a-4827-9b0e-4bfeed2b57bf 0019-1177 HUMAN PRESCRIPTION DRUG OPTIMARK GADOVERSETAMIDE INJECTION, SOLUTION INTRAVENOUS 20101210 NDA NDA020975 Liebel-Flarsheim Company LLC GADOVERSETAMIDE .5 mmol/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] N 20181231 0019-1177_7e2d1a09-1e7c-4198-b0cb-5a0fbf2f3609 0019-1177 HUMAN PRESCRIPTION DRUG OPTIMARK gadoversetamide INJECTION, SOLUTION INTRAVENOUS 20120122 NDA NDA020976 Liebel-Flarsheim Company LLC GADOVERSETAMIDE .5 mmol/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] N 20181231 0019-1177_afe538c1-eb7d-4f5f-b83b-b73e6a055e54 0019-1177 HUMAN PRESCRIPTION DRUG OPTIMARK gadoversetamide INJECTION, SOLUTION INTRAVENOUS 20120122 NDA NDA020937 Liebel-Flarsheim Company LLC GADOVERSETAMIDE .5 mmol/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] N 20181231 0019-1188_44fdbc1f-4809-4fa0-954b-b38988d88940 0019-1188 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVASCULAR 20120901 NDA NDA021569 Liebel-Flarsheim Company LLC SODIUM CHLORIDE .9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0019-1323_301a35b0-6c40-4445-8faf-b7bd4f8d5967 0019-1323 HUMAN PRESCRIPTION DRUG Optiray 320 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20120304 NDA NDA019710 Liebel-Flarsheim Company LLC IOVERSOL 678 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0019-1323_32bacc07-27c9-4c39-89c2-7233efc3e82f 0019-1323 HUMAN PRESCRIPTION DRUG Optiray 320 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20111017 NDA NDA020923 Liebel-Flarsheim Company LLC IOVERSOL 678 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0019-1324_301a35b0-6c40-4445-8faf-b7bd4f8d5967 0019-1324 HUMAN PRESCRIPTION DRUG Optiray 240 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20120304 NDA NDA019710 Liebel-Flarsheim Company LLC IOVERSOL 509 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0019-1332_301a35b0-6c40-4445-8faf-b7bd4f8d5967 0019-1332 HUMAN PRESCRIPTION DRUG Optiray 300 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20120304 NDA NDA019710 Liebel-Flarsheim Company LLC IOVERSOL 636 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0019-1332_32bacc07-27c9-4c39-89c2-7233efc3e82f 0019-1332 HUMAN PRESCRIPTION DRUG Optiray 300 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20111017 NDA NDA020923 Liebel-Flarsheim Company LLC IOVERSOL 636 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0019-1333_301a35b0-6c40-4445-8faf-b7bd4f8d5967 0019-1333 HUMAN PRESCRIPTION DRUG Optiray 350 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20120304 NDA NDA019710 Liebel-Flarsheim Company LLC IOVERSOL 741 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0019-1333_32bacc07-27c9-4c39-89c2-7233efc3e82f 0019-1333 HUMAN PRESCRIPTION DRUG Optiray 350 Ioversol INJECTION INTRA-ARTERIAL; INTRAVENOUS 20111017 NDA NDA020923 Liebel-Flarsheim Company LLC IOVERSOL 741 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0019-3183_c03aaec4-d659-4805-ae8d-0b582bd72505 0019-3183 HUMAN PRESCRIPTION DRUG Conray 43 iothalamate meglumine INJECTION INTRAVASCULAR 20101011 NDA NDA013295 Liebel-Flarsheim Company LLC IOTHALAMATE MEGLUMINE 430 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0019-4816_0be468dc-3655-45ce-bcfb-a489086f3c87 0019-4816 HUMAN PRESCRIPTION DRUG MD GASTROVIEW diatrizoate meglumine and diatrizoate sodium SOLUTION ORAL; RECTAL 20090831 ANDA ANDA087388 Liebel-Flarsheim Company LLC DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 600; 100 mg/mL; mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0023-0042_ca6ba093-8b7e-455a-b9ab-74e249420add 0023-0042 HUMAN PRESCRIPTION DRUG TAZORAC tazarotene GEL CUTANEOUS 19970801 NDA NDA020600 Allergan, Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0023-0066_a26a1cd1-2903-4fc8-ad34-86ae16459f15 0023-0066 HUMAN PRESCRIPTION DRUG PRED-G gentamicin sulfate and prednisolone acetate OINTMENT OPHTHALMIC 19900101 NDA NDA050612 Allergan, Inc. GENTAMICIN SULFATE; PREDNISOLONE ACETATE 3; 6 mg/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0023-0106_e7437506-4ebf-4292-83f1-c6bcab47bda1 0023-0106 HUMAN PRESCRIPTION DRUG PRED-G gentamicin, prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19900219 NDA NDA050586 Allergan, Inc. GENTAMICIN; PREDNISOLONE ACETATE 3; 10 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0023-0240_7326fd66-dc91-4686-a7b6-c1def9f74767 0023-0240 HUMAN OTC DRUG REFRESH P.M. mineral oil, petrolatum OINTMENT OPHTHALMIC 19900423 OTC MONOGRAPH FINAL part349 Allergan, Inc. MINERAL OIL; PETROLATUM 425; 573 mg/g; mg/g N 20181231 0023-0312_9360c78f-e2dd-43cd-99d3-9637db2025e5 0023-0312 HUMAN OTC DRUG REFRESH LACRI-LUBE mineral oil, petrolatum OINTMENT OPHTHALMIC 19771215 OTC MONOGRAPH FINAL part349 Allergan, Inc. MINERAL OIL; PETROLATUM 425; 568 mg/g; mg/g N 20191231 0023-0313_3c674c50-aadd-46d4-8bd0-658a86213a5c 0023-0313 HUMAN PRESCRIPTION DRUG BLEPHAMIDE sulfacetamide sodium and prednisolone acetate OINTMENT OPHTHALMIC 19870101 ANDA ANDA087748 Allergan, Inc. SULFACETAMIDE SODIUM; PREDNISOLONE ACETATE 100; 2 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0023-0316_4c878c06-935d-40b5-9d9e-27ff3647bc67 0023-0316 HUMAN PRESCRIPTION DRUG FML fluorometholone OINTMENT OPHTHALMIC 19851209 NDA NDA017760 Allergan, Inc. FLUOROMETHOLONE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0023-0403_488a2c5c-4e12-475d-9394-356184fa89c2 0023-0403 HUMAN OTC DRUG REFRESH PLUS carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 19961009 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 0023-0506_480f89e2-36aa-4e1c-8648-ff2c588dedda 0023-0506 HUMAN OTC DRUG REFRESH Classic Polyvinyl Alcohol, Povidone SOLUTION/ DROPS OPHTHALMIC 19850912 OTC MONOGRAPH FINAL part349 Allergan, Inc. POLYVINYL ALCOHOL; POVIDONE 14; 6 mg/mL; mg/mL N 20181231 0023-0752_e5745dfa-8032-4b70-b5a8-38b801bd1adc 0023-0752 HUMAN PRESCRIPTION DRUG Asacol mesalamine TABLET, DELAYED RELEASE ORAL 19920401 NDA NDA019651 Allergan, Inc. MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0023-0798_0fbfc3b3-9bd9-4bea-8f5d-0edaa8505c99 0023-0798 HUMAN OTC DRUG REFRESH TEARS carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 19970516 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 0023-1145_e3d7b38d-cd47-4c2f-8808-e298499a7ba8 0023-1145 HUMAN PRESCRIPTION DRUG BOTOX onabotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRADERMAL; INTRAMUSCULAR 19891215 BLA BLA103000 Allergan, Inc. BOTULINUM TOXIN TYPE A 100 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 0023-2181_2df33f5e-153b-43fe-b56f-300599573549 0023-2181 HUMAN PRESCRIPTION DRUG Acular Ketorolac Tromethamine SOLUTION/ DROPS OPHTHALMIC 19921201 NDA NDA019700 Allergan, Inc. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0023-3205_87403afb-5e81-49e7-832f-ac98b765ed5c 0023-3205 HUMAN PRESCRIPTION DRUG LUMIGAN bimatoprost SOLUTION/ DROPS OPHTHALMIC 20100910 NDA NDA022184 Allergan, Inc. BIMATOPROST .1 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 0023-3240_37b995e8-8e66-4d9b-b027-d58c053c7364 0023-3240 HUMAN OTC DRUG REFRESH OPTIVE carboxymethylcellulose sodium and glycerin SOLUTION/ DROPS OPHTHALMIC 20060906 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 0023-3348_95e19b00-4334-44d1-9726-487bf786bdff 0023-3348 HUMAN PRESCRIPTION DRUG OZURDEX dexamethasone IMPLANT INTRAVITREAL 20090901 NDA NDA022315 Allergan, Inc. DEXAMETHASONE .7 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0023-3416_5d54b37d-334b-4034-9df1-f360d0b74783 0023-3416 HUMAN OTC DRUG Refresh Optive Carboxymethylcellulose Sodium, Glycerin SOLUTION/ DROPS OPHTHALMIC 20080822 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 0023-3507_49a1ec4a-0210-45e7-927b-9118cd69c526 0023-3507 HUMAN PRESCRIPTION DRUG ACUVAIL ketorolac tromethamine SOLUTION/ DROPS OPHTHALMIC 20090801 NDA NDA022427 Allergan, Inc. KETOROLAC TROMETHAMINE 4.5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0023-3615_2ced5ec1-e50f-45ae-acdf-db50920f2d38 0023-3615 HUMAN PRESCRIPTION DRUG ZYMAXID gatifloxacin SOLUTION/ DROPS OPHTHALMIC 20100519 NDA NDA022548 Allergan, Inc. GATIFLOXACIN 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0023-3616_c38a4d54-cf63-4c26-bbc4-756cb328f3c0 0023-3616 HUMAN PRESCRIPTION DRUG LATISSE bimatoprost SOLUTION/ DROPS OPHTHALMIC 20090126 NDA NDA022369 Allergan, Inc. BIMATOPROST .3 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 0023-3670_abbfee6f-4526-4702-9790-88b7d22b8b93 0023-3670 HUMAN PRESCRIPTION DRUG ACZONE dapsone GEL TOPICAL 20090624 NDA NDA021794 Allergan, Inc. DAPSONE 50 mg/g Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 0023-3919_5ada09bc-0499-4659-9cd0-623bd217871f 0023-3919 HUMAN PRESCRIPTION DRUG BOTOX Cosmetic onabotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20080715 BLA BLA103000 Allergan, Inc. BOTULINUM TOXIN TYPE A 50 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 0023-3921_e3d7b38d-cd47-4c2f-8808-e298499a7ba8 0023-3921 HUMAN PRESCRIPTION DRUG BOTOX onabotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRADERMAL; INTRAMUSCULAR 20100111 BLA BLA103000 Allergan, Inc. BOTULINUM TOXIN TYPE A 200 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 0023-4290_7b166e5e-3794-46f0-a6af-01803442c680 0023-4290 HUMAN PRESCRIPTION DRUG LASTACAFT alcaftadine SOLUTION/ DROPS OPHTHALMIC 20101101 NDA NDA022134 Allergan, Inc. ALCAFTADINE 2.5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0023-4307_049bae5a-4bf2-4216-9c3d-6e57efeabd93 0023-4307 HUMAN OTC DRUG REFRESH OPTIVE Advanced carboxymethylcellulose sodium, glycerin, and polysorbate 80 SOLUTION/ DROPS OPHTHALMIC 20111130 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN; POLYSORBATE 80 5; 10; 5 mg/mL; mg/mL; mg/mL N 20181231 0023-4385_12f961ac-30d9-483b-9289-de3bd49fb320 0023-4385 HUMAN PRESCRIPTION DRUG BETAGAN levobunolol hydrochloride SOLUTION/ DROPS OPHTHALMIC 19860724 NDA NDA019219 Allergan, Inc. LEVOBUNOLOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 0023-4491_e600f562-8c1c-48a4-bc74-2fcb405fac4a 0023-4491 HUMAN OTC DRUG REFRESH OPTIVE Advanced carboxymethylcellulose sodium, glycerin, polysorbate 80 SOLUTION/ DROPS OPHTHALMIC 20130115 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN; POLYSORBATE 80 5; 10; 5 mg/mL; mg/mL; mg/mL N 20181231 0023-4554_4db541ed-33fe-4047-ac24-b2b3117f2ba4 0023-4554 HUMAN OTC DRUG REFRESH CELLUVISC carboxymethylcellulose sodium GEL OPHTHALMIC 19891004 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM 10 mg/mL N 20181231 0023-4857_ece0d31a-5218-495e-bd40-bc1cbed86f78 0023-4857 HUMAN PRESCRIPTION DRUG VANIQA eflornithine hydrochloride CREAM TOPICAL 20130601 NDA NDA021145 Allergan, Inc. EFLORNITHINE HYDROCHLORIDE 139 mg/g Antiprotozoal [EPC],Decarboxylase Inhibitor [EPC],Decarboxylase Inhibitors [MoA] N 20181231 0023-4948_25aa28a7-44df-4a7f-a8a9-8d72ac6b5f2b 0023-4948 HUMAN OTC DRUG SKIN MEDICA Purifying Foaming Wash salicylic acid LIQUID TOPICAL 20130101 OTC MONOGRAPH FINAL part333D Allergan, Inc. SALICYLIC ACID 20 mg/mL N 20181231 0023-4953_010c0467-db08-4225-9eee-5940e6427496 0023-4953 HUMAN OTC DRUG SkinMedica TNS Ultimate Daily Moisturizer Sunscreen SPF 20 octinoxate, zinc oxide CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Allergan, Inc. OCTINOXATE; ZINC OXIDE 75; 53 mg/g; mg/g N 20181231 0023-4965_4507c733-5f5d-4259-bd08-bd882f2331a7 0023-4965 HUMAN OTC DRUG SkinMedica Acne Treatment benzoyl peroxide LOTION TOPICAL 20130101 OTC MONOGRAPH FINAL part333D Allergan, Inc. BENZOYL PEROXIDE 25 mg/g N 20181231 0023-5206_3e79fa8d-8b32-4578-8ca4-012bfcdd910d 0023-5206 HUMAN PRESCRIPTION DRUG ACZONE (dapsone) Gel, 7.5% dapsone GEL TOPICAL 20160226 NDA NDA207154 Allergan, Inc. DAPSONE 75 mg/g Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 0023-5300_10f41d1d-bc01-4190-9830-a58b4a3f81e6 0023-5300 HUMAN PRESCRIPTION DRUG RHOFADE Oxymetazoline Hydrochloride CREAM TOPICAL 20170118 NDA NDA208552 Allergan OXYMETAZOLINE HYDROCHLORIDE 10 mg/g Vasoconstrictor [EPC],Vasoconstriction [PE],Increased Sympathetic Activity [PE],Imidazolines [Chemical/Ingredient] N 20181231 0023-5301_e579186c-6dfc-41c3-9cc9-a32d36352507 0023-5301 HUMAN PRESCRIPTION DRUG Restasis MultiDose cyclosporine EMULSION OPHTHALMIC 20161110 NDA NDA050790 Allergan, Inc. CYCLOSPORINE .5 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0023-5459_966eb50a-8f7a-48de-ac6e-1b2c8e951410 0023-5459 HUMAN OTC DRUG REFRESH OPTIVE Gel Drops carboxymethylcellulose sodium and glycerin SOLUTION/ DROPS OPHTHALMIC 20150930 OTC MONOGRAPH FINAL part349 Allergan, INC CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 10; 9 mg/mL; mg/mL N 20181231 0023-5494_03ba12e7-624f-4dec-aef4-9e20f9a5b0b4 0023-5494 HUMAN OTC DRUG TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen Octinoxate, Octisalate and Zinc Oxide LOTION TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part352 Allergan, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 30; 80 mg/g; mg/g; mg/g N 20181231 0023-5497_b6a34031-7703-4939-ad6a-fac1e23d99b5 0023-5497 HUMAN OTC DRUG TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted) Octinoxate, Octisalate, Titanium dioxide and Zinc Oxide LOTION TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part352 Allergan, Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 30; 35; 80 mg/g; mg/g; mg/g; mg/g N 20181231 0023-5501_86db1edc-3739-4c89-95b4-89fd67d18bf0 0023-5501 HUMAN OTC DRUG TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 50 Sunscreen Homosalate, Octinoxate, Octisalate and Zinc Oxide LOTION TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part352 Allergan, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; ZINC OXIDE 60; 75; 50; 10 mg/g; mg/g; mg/g; mg/g N 20181231 0023-5675_5276a019-64bd-4606-bc9f-9040b74a8f85 0023-5675 HUMAN OTC DRUG Essential Defense Mineral Shield Broad Spectrum SPF 32 TINTED Sunscreen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20160316 OTC MONOGRAPH NOT FINAL part352 Allergan, Inc. TITANIUM DIOXIDE; ZINC OXIDE 50; 60 mg/g; mg/g N 20181231 0023-5703_8dbc7b3a-130c-4009-abce-507034d52e7b 0023-5703 HUMAN OTC DRUG Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen Titanium Dioxide and Zinc oxide LOTION TOPICAL 20160316 OTC MONOGRAPH NOT FINAL part352 Allergan, Inc. TITANIUM DIOXIDE; ZINC OXIDE 50; 60 mg/g; mg/g N 20181231 0023-5738_b05fde3b-ed14-43e4-a64f-96d6776895fa 0023-5738 HUMAN OTC DRUG Essential Defense Everyday Clear Broad Spectrum SPF 47 Sunscreen Zinc Oxide and Octinoxate LOTION TOPICAL 20160316 OTC MONOGRAPH NOT FINAL part352 Allergan, Inc. ZINC OXIDE; OCTINOXATE 120; 75 mg/g; mg/g N 20181231 0023-5773_bad13e61-f80c-47f1-a061-f779694e6d56 0023-5773 HUMAN OTC DRUG REFRESH OPTIVE Mega-3 Carboxymethylcellulose sodium, Glycerin and Polysorbate 80 SOLUTION/ DROPS OPHTHALMIC 20170530 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN; POLYSORBATE 80 5; 10; 5 mg/mL; mg/mL; mg/mL N 20181231 0023-5812_8383140d-93e2-4f6b-bd81-8790c3011498 0023-5812 HUMAN PRESCRIPTION DRUG GELNIQUE oxybutynin chloride GEL TRANSDERMAL 20170401 NDA NDA022204 Allergan, Inc. OXYBUTYNIN CHLORIDE 100 mg/g Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0023-5853_406e9b70-cd62-4418-b188-5e6524f52d51 0023-5853 HUMAN PRESCRIPTION DRUG Delzicol mesalamine CAPSULE, DELAYED RELEASE ORAL 20160516 NDA NDA204412 Allergan, Inc. MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0023-5858_bd4a5328-e0fd-4a6c-8ab9-91ccd591c16c 0023-5858 HUMAN PRESCRIPTION DRUG LILETTA Levonorgestrel INTRAUTERINE DEVICE INTRAUTERINE 20160531 NDA NDA206229 Allergan, Inc. LEVONORGESTREL 52 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] N 20181231 0023-5861_8383140d-93e2-4f6b-bd81-8790c3011498 0023-5861 HUMAN PRESCRIPTION DRUG GELNIQUE oxybutynin chloride GEL TRANSDERMAL 20170401 NDA NDA022204 Allergan, Inc. OXYBUTYNIN CHLORIDE 100 mg/g Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0023-5862_65355748-4145-4827-862c-fae9b6cecd68 0023-5862 HUMAN PRESCRIPTION DRUG Taytulla norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20160501 NDA NDA204426 Allergan, Inc. N 20181231 0023-5868_3daf6e91-1830-49c7-b50e-1a7e856d968a 0023-5868 HUMAN PRESCRIPTION DRUG Femring estradiol acetate RING VAGINAL 20160502 NDA NDA021367 Allergan, Inc. ESTRADIOL ACETATE .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0023-5869_3daf6e91-1830-49c7-b50e-1a7e856d968a 0023-5869 HUMAN PRESCRIPTION DRUG Femring estradiol acetate RING VAGINAL 20160502 NDA NDA021367 Allergan, Inc. ESTRADIOL ACETATE .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0023-5870_acf749c1-e4bb-4459-b5bc-a9fc497c9823 0023-5870 HUMAN PRESCRIPTION DRUG Cordran Flurandrenolide TAPE TOPICAL 20160815 NDA NDA016455 Allergan, Inc. FLURANDRENOLIDE 4 ug/cm2 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0023-5874_89cb3193-33fc-4ff6-983f-0f179bf2c648 0023-5874 HUMAN PRESCRIPTION DRUG Byvalson nebivolol hydrochloride and valsartan TABLET, FILM COATED ORAL 20160603 NDA NDA206302 Allergan, Inc NEBIVOLOL HYDROCHLORIDE; VALSARTAN 5; 80 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0023-5885_fe1801a9-de14-4a1e-ba94-e537cdf5ae1a 0023-5885 HUMAN PRESCRIPTION DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL 20020405 NDA NDA020655 Allergan, Inc. ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0023-5886_fe1801a9-de14-4a1e-ba94-e537cdf5ae1a 0023-5886 HUMAN PRESCRIPTION DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL 19961220 NDA NDA020655 Allergan, Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0023-5887_fe1801a9-de14-4a1e-ba94-e537cdf5ae1a 0023-5887 HUMAN PRESCRIPTION DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL 19961220 NDA NDA020655 Allergan, Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0023-5888_fe1801a9-de14-4a1e-ba94-e537cdf5ae1a 0023-5888 HUMAN PRESCRIPTION DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL 19961220 NDA NDA020655 Allergan, Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0023-5901_7e083ad0-ee99-4e1d-b13a-48786dd3d14d 0023-5901 HUMAN PRESCRIPTION DRUG Asacol HD mesalamine TABLET, DELAYED RELEASE ORAL 20080528 NDA NDA021830 Allergan, Inc. MESALAMINE 800 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0023-5902_f216b501-430c-45dd-bf38-f8972a9c1768 0023-5902 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate KIT 20000615 NDA NDA020715 Allergan, Inc. N 20191231 0023-5904_f216b501-430c-45dd-bf38-f8972a9c1768 0023-5904 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate KIT 20010629 NDA NDA021288 Allergan, Inc. N 20191231 0023-5906_f216b501-430c-45dd-bf38-f8972a9c1768 0023-5906 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate KIT 20100311 NDA NDA022437 Allergan, Inc. N 20191231 0023-5920_21b14ebe-ab63-48b5-8306-4392398b15e2 0023-5920 HUMAN PRESCRIPTION DRUG Nuvessa metronidazole GEL VAGINAL 20150101 NDA NDA205223 Allergan, Inc. METRONIDAZOLE 65 mg/5g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0023-5970_83697cee-7db6-4b24-a606-7ee2cf757157 0023-5970 HUMAN PRESCRIPTION DRUG FEMCON Fe norethindrone and ethinyl estradiol, and ferrous fumarate KIT 20061101 NDA NDA021490 Allergan, Inc. N 20181231 0023-5990_9d683d56-605a-487e-8c04-5b617b453aaf 0023-5990 HUMAN PRESCRIPTION DRUG Androderm Testosterone PATCH TRANSDERMAL 19950929 NDA NDA020489 Allergan, Inc. TESTOSTERONE 2 mg/d Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0023-5992_9d683d56-605a-487e-8c04-5b617b453aaf 0023-5992 HUMAN PRESCRIPTION DRUG Androderm Testosterone PATCH TRANSDERMAL 19950929 NDA NDA020489 Allergan, Inc. TESTOSTERONE 4 mg/d Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0023-6002_6991afdf-596c-44cf-8497-2f4a7272fe7e 0023-6002 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160501 ANDA ANDA040099 Allergan, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 0023-6010_2c40750d-e27d-4900-825b-219640494559 0023-6010 HUMAN PRESCRIPTION DRUG Fiorinal with Codeine Butalbital, Aspirin, Caffeine, and Codeine Phosphate CAPSULE ORAL 19901026 NDA NDA019429 Allergan, Inc. BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 50 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0023-6011_eba483a8-ccb1-4147-bea8-bc7a9bc6110a 0023-6011 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Allergan, Inc. MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0023-6012_eba483a8-ccb1-4147-bea8-bc7a9bc6110a 0023-6012 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Allergan, Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0023-6013_eba483a8-ccb1-4147-bea8-bc7a9bc6110a 0023-6013 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Allergan, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0023-6014_eba483a8-ccb1-4147-bea8-bc7a9bc6110a 0023-6014 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120507 NDA NDA020616 Allergan, Inc. MORPHINE SULFATE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0023-6015_eba483a8-ccb1-4147-bea8-bc7a9bc6110a 0023-6015 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Allergan, Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0023-6016_eba483a8-ccb1-4147-bea8-bc7a9bc6110a 0023-6016 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Allergan, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0023-6017_eba483a8-ccb1-4147-bea8-bc7a9bc6110a 0023-6017 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Allergan, Inc. MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0023-6018_eba483a8-ccb1-4147-bea8-bc7a9bc6110a 0023-6018 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Allergan, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0023-6019_eba483a8-ccb1-4147-bea8-bc7a9bc6110a 0023-6019 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Allergan, Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0023-6021_6991afdf-596c-44cf-8497-2f4a7272fe7e 0023-6021 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130312 ANDA ANDA040148 Allergan, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 0023-6022_6991afdf-596c-44cf-8497-2f4a7272fe7e 0023-6022 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130312 ANDA ANDA040148 Allergan, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 0023-6030_f8487b99-7655-492e-acaf-7eaf1026466e 0023-6030 HUMAN PRESCRIPTION DRUG GENERESS Fe norethindrone and ethinyl estradiol and ferrous fumarate KIT ORAL 20111223 NDA NDA022573 Allergan, Inc. N 20181231 0023-6082_0d86d9e3-022e-4d75-a80c-fc9cdd002e3c 0023-6082 HUMAN PRESCRIPTION DRUG INFeD Iron Dextran INJECTION INTRAMUSCULAR; INTRAVENOUS 19740429 NDA NDA017441 Allergan, Inc. IRON DEXTRAN 50 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0023-6110_d51d15d1-a580-4b93-9a36-3e6b9aa2a1fd 0023-6110 HUMAN PRESCRIPTION DRUG Zenpep PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE CAPSULE, DELAYED RELEASE ORAL 20171031 NDA NDA022210 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 10000; 32000; 42000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20191231 0023-6111_d51d15d1-a580-4b93-9a36-3e6b9aa2a1fd 0023-6111 HUMAN PRESCRIPTION DRUG Zenpep PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE CAPSULE, DELAYED RELEASE ORAL 20171006 NDA NDA022210 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 15000; 47000; 63000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20191231 0023-6112_d51d15d1-a580-4b93-9a36-3e6b9aa2a1fd 0023-6112 HUMAN PRESCRIPTION DRUG Zenpep PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE CAPSULE, DELAYED RELEASE ORAL 20170826 NDA NDA022210 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 20000; 63000; 84000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20191231 0023-6113_d51d15d1-a580-4b93-9a36-3e6b9aa2a1fd 0023-6113 HUMAN PRESCRIPTION DRUG Zenpep PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE CAPSULE, DELAYED RELEASE ORAL 20171031 NDA NDA022210 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 3000; 10000; 14000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20191231 0023-6114_d51d15d1-a580-4b93-9a36-3e6b9aa2a1fd 0023-6114 HUMAN PRESCRIPTION DRUG Zenpep PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE CAPSULE, DELAYED RELEASE ORAL 20171015 NDA NDA022210 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 40000; 126000; 168000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20191231 0023-6115_d51d15d1-a580-4b93-9a36-3e6b9aa2a1fd 0023-6115 HUMAN PRESCRIPTION DRUG Zenpep PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE CAPSULE, DELAYED RELEASE ORAL 20171013 NDA NDA022210 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 5000; 17000; 24000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20191231 0023-6116_d51d15d1-a580-4b93-9a36-3e6b9aa2a1fd 0023-6116 HUMAN PRESCRIPTION DRUG Zenpep PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE CAPSULE, DELAYED RELEASE ORAL 20171006 NDA NDA022210 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 25000; 79000; 105000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20191231 0023-6118_48b06597-e512-456a-bcdf-85e1f879aa95 0023-6118 HUMAN PRESCRIPTION DRUG Condylox podofilox GEL TOPICAL 19970313 NDA NDA020529 Allergan, Inc. PODOFILOX 5 mg/g Decreased Mitosis [PE] N 20181231 0023-6142_b0dd9d42-0983-47b7-a88e-de9f62e70626 0023-6142 HUMAN PRESCRIPTION DRUG RAPAFLO silodosin CAPSULE ORAL 20090323 NDA NDA022206 Allergan, Inc. SILODOSIN 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0023-6145_bfc3ea7f-9e88-496b-a8ed-619d7d8250fa 0023-6145 HUMAN PRESCRIPTION DRUG Actigall Ursodiol CAPSULE ORAL 19871231 NDA NDA019594 Allergan, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 0023-6147_b0dd9d42-0983-47b7-a88e-de9f62e70626 0023-6147 HUMAN PRESCRIPTION DRUG RAPAFLO silodosin CAPSULE ORAL 20090323 NDA NDA022206 Allergan, Inc. SILODOSIN 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0023-6150_84e83777-e939-4348-a85e-b10083e2eec9 0023-6150 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 NDA NDA020701 Allergan, Inc. PROGESTERONE 45 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 0023-6151_84e83777-e939-4348-a85e-b10083e2eec9 0023-6151 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 NDA NDA020701 Allergan, Inc. PROGESTERONE 90 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 0023-6153_f36f3819-927f-4ec6-a42e-333af9a6907a 0023-6153 HUMAN PRESCRIPTION DRUG OXYTROL Oxybutynin PATCH TRANSDERMAL 20030226 NDA NDA021351 Allergan, Inc. OXYBUTYNIN 3.9 mg/d Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0023-7824_38fea9d7-947f-4303-91c4-30a2a08e98ae 0023-7824 HUMAN PRESCRIPTION DRUG Polytrim polymyxin b sulfate and trimethoprim sulfate SOLUTION/ DROPS OPHTHALMIC 19900123 NDA NDA050567 Allergan, Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 100000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 0023-8335_ca6ba093-8b7e-455a-b9ab-74e249420add 0023-8335 HUMAN PRESCRIPTION DRUG TAZORAC tazarotene GEL CUTANEOUS 19970801 NDA NDA020600 Allergan, Inc. TAZAROTENE .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0023-8694_d7a96fba-04c1-4af1-9e4b-6e22d4e1fdd0 0023-8694 HUMAN PRESCRIPTION DRUG AZELEX azelaic acid CREAM CUTANEOUS 19960321 NDA NDA020428 Allergan, Inc. AZELAIC ACID .2 g/g Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] N 20181231 0023-8842_9cfd2014-4e4d-4b33-ac5d-8a96b29f30b8 0023-8842 HUMAN PRESCRIPTION DRUG ALOCRIL nedocromil sodium SOLUTION/ DROPS OPHTHALMIC 20000203 NDA NDA021009 Allergan, Inc. NEDOCROMIL SODIUM 20 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 0023-9155_bb6d822b-d39b-40ac-b40c-b29289176c70 0023-9155 HUMAN PRESCRIPTION DRUG TAZORAC tazarotene CREAM CUTANEOUS 20001115 NDA NDA021184 Allergan, Inc. TAZAROTENE .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0023-9156_bb6d822b-d39b-40ac-b40c-b29289176c70 0023-9156 HUMAN PRESCRIPTION DRUG TAZORAC tazarotene CREAM CUTANEOUS 20001113 NDA NDA021184 Allergan, Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0023-9163_5a4081c8-5d62-44b3-b72f-36c03f2c86a8 0023-9163 HUMAN PRESCRIPTION DRUG RESTASIS cyclosporine EMULSION OPHTHALMIC 20030401 NDA NDA050790 Allergan, Inc. CYCLOSPORINE .5 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0023-9177_70cc5d7f-836e-4035-bb3d-1da8481f867c 0023-9177 HUMAN PRESCRIPTION DRUG ALPHAGAN P brimonidine tartrate SOLUTION/ DROPS OPHTHALMIC 20010710 NDA NDA021262 Allergan, Inc. BRIMONIDINE TARTRATE 1.5 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0023-9201_75ad94a2-5508-443e-8143-2bb27a7e2466 0023-9201 HUMAN PRESCRIPTION DRUG ELESTAT epinastine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20040119 NDA NDA021565 Allergan, Inc. EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 0023-9205_29dd09ac-bec3-4956-b98a-28d254e496e2 0023-9205 HUMAN OTC DRUG REFRESH LIQUIGEL Carboxymethylcellulose sodium GEL OPHTHALMIC 20011004 OTC MONOGRAPH FINAL part349 Allergan, Inc. CARBOXYMETHYLCELLULOSE SODIUM 10 mg/mL N 20181231 0023-9211_2e560ec1-3499-4364-a43d-904d72376e2f 0023-9211 HUMAN PRESCRIPTION DRUG COMBIGAN brimonidine tartrate, timolol maleate SOLUTION/ DROPS OPHTHALMIC 20071114 NDA NDA021398 Allergan, Inc. BRIMONIDINE TARTRATE; TIMOLOL MALEATE 2; 5 mg/mL; mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0023-9232_5ada09bc-0499-4659-9cd0-623bd217871f 0023-9232 HUMAN PRESCRIPTION DRUG BOTOX Cosmetic onabotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20080520 BLA BLA103000 Allergan, Inc. BOTULINUM TOXIN TYPE A 100 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 0023-9236_a2e46dae-939c-4984-a003-59e0d00f18b4 0023-9236 HUMAN PRESCRIPTION DRUG AVAGE tazarotene CREAM CUTANEOUS 20030107 NDA NDA021184 Allergan, Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0023-9277_54d6d56e-f44b-4d02-a1b2-8a9033080e73 0023-9277 HUMAN PRESCRIPTION DRUG ACULAR LS Ketorolac Tromethamine SOLUTION/ DROPS OPHTHALMIC 20030819 NDA NDA021528 Allergan, Inc. KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0023-9321_70cc5d7f-836e-4035-bb3d-1da8481f867c 0023-9321 HUMAN PRESCRIPTION DRUG ALPHAGAN P brimonidine tartrate SOLUTION/ DROPS OPHTHALMIC 20060125 NDA NDA021770 Allergan, Inc. BRIMONIDINE TARTRATE 1 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0024-0335_4b1bd4df-00b7-4620-9dc5-bce675a412eb 0024-0335 HUMAN PRESCRIPTION DRUG Demerol Meperidine Hydrochloride TABLET ORAL 19421110 NDA NDA005010 sanofi-aventis U.S. LLC MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0024-0335_e880e6cc-4018-4bea-a722-b8c94a588b34 0024-0335 HUMAN PRESCRIPTION DRUG Demerol Meperidine Hydrochloride TABLET ORAL 20130401 NDA NDA005010 sanofi-aventis U.S. LLC MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0024-0337_4b1bd4df-00b7-4620-9dc5-bce675a412eb 0024-0337 HUMAN PRESCRIPTION DRUG Demerol Meperidine Hydrochloride TABLET ORAL 19421110 NDA NDA005010 sanofi-aventis U.S. LLC MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0024-0337_e880e6cc-4018-4bea-a722-b8c94a588b34 0024-0337 HUMAN PRESCRIPTION DRUG Demerol Meperidine Hydrochloride TABLET ORAL 20120521 NDA NDA005010 sanofi-aventis U.S. LLC MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0024-0590_1dcf6847-980e-4e6f-a5ae-926a1706e248 0024-0590 HUMAN PRESCRIPTION DRUG ELOXATIN oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060602 NDA NDA021759 sanofi-aventis U.S. LLC OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0024-0591_1dcf6847-980e-4e6f-a5ae-926a1706e248 0024-0591 HUMAN PRESCRIPTION DRUG ELOXATIN oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060602 NDA NDA021759 sanofi-aventis U.S. LLC OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0024-1596_e98f9e68-e83d-43f1-8add-a0b9cc5614b9 0024-1596 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET, FILM COATED ORAL 20110415 NDA NDA008316 sanofi-aventis U.S. LLC PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] N 20181231 0024-2792_d4a8b488-b33f-456d-bb00-4932fe4cebda 0024-2792 HUMAN PRESCRIPTION DRUG Ferrlecit sodium ferric gluconate complex INJECTION INTRAVENOUS 20110301 NDA NDA020955 sanofi-aventis U.S. LLC SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0024-2794_586f2e14-e9ca-4669-ad40-54ec070ec78e 0024-2794 HUMAN PRESCRIPTION DRUG Ferrlecit sodium ferric gluconate complex INJECTION INTRAVENOUS 20140707 NDA NDA020955 sanofi-aventis U.S. LLC SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0024-4142_63ea5a96-12b8-47be-8977-8c40ff8f5b5f 0024-4142 HUMAN PRESCRIPTION DRUG Multaq Dronedarone TABLET, FILM COATED ORAL 20090701 NDA NDA022425 sanofi-aventis U.S. LLC DRONEDARONE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0024-5150_3917e906-51a8-4162-850b-e1b2b25141eb 0024-5150 HUMAN PRESCRIPTION DRUG Elitek rasburicase KIT 20020712 BLA BLA103946 sanofi-aventis U.S. LLC N 20181231 0024-5151_3917e906-51a8-4162-850b-e1b2b25141eb 0024-5151 HUMAN PRESCRIPTION DRUG Elitek rasburicase KIT 20060601 BLA BLA103940 sanofi-aventis U.S. LLC N 20181231 0024-5401_7c53c16e-bd14-4a14-8194-c6146e86e203 0024-5401 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 19930401 NDA NDA019908 sanofi-aventis U.S. LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0024-5421_7c53c16e-bd14-4a14-8194-c6146e86e203 0024-5421 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 19930401 NDA NDA019908 sanofi-aventis U.S. LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0024-5501_6eba91c0-7665-4af2-925e-c9a722687eb5 0024-5501 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20050919 NDA NDA021774 sanofi-aventis U.S. LLC ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0024-5521_6eba91c0-7665-4af2-925e-c9a722687eb5 0024-5521 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20050919 NDA NDA021774 sanofi-aventis U.S. LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0024-5745_8c1a83cb-bcbb-40a1-ab02-7d6917f76dd8 0024-5745 HUMAN PRESCRIPTION DRUG ADLYXIN Lixisenatide KIT 20160727 NDA NDA208471 Sanofi-Aventis U.S. LLC N 20181231 0024-5747_8c1a83cb-bcbb-40a1-ab02-7d6917f76dd8 0024-5747 HUMAN PRESCRIPTION DRUG ADLYXIN Lixisenatide INJECTION, SOLUTION SUBCUTANEOUS 20160727 NDA NDA208471 Sanofi-Aventis U.S. LLC LIXISENATIDE 100 ug/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20181231 0024-5761_e4e75cc9-4d65-46b6-9e7a-d6c433c580e9 0024-5761 HUMAN PRESCRIPTION DRUG Soliqua 100/33 insulin glargine and lixisenatide INJECTION, SOLUTION SUBCUTANEOUS 20161121 NDA NDA208673 Sanofi-Aventis U.S. LLC INSULIN GLARGINE; LIXISENATIDE 100; 33 U/mL; ug/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC],GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20181231 0024-5800_226af22f-7dd3-4c63-a40f-0c1635868d8e 0024-5800 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride TABLET, FILM COATED ORAL 20070809 NDA NDA022064 Sanofi-Aventis U.S. LLC LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 0024-5801_226af22f-7dd3-4c63-a40f-0c1635868d8e 0024-5801 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride SOLUTION ORAL 20080402 NDA NDA022157 Sanofi-Aventis U.S. LLC LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 0024-5812_c25bf565-8061-450a-9217-a7a280ee0424 0024-5812 HUMAN PRESCRIPTION DRUG Aplenzin bupropion hydrobromide TABLET, EXTENDED RELEASE ORAL 20090330 NDA NDA022108 sanofi-aventis U.S. LLC BUPROPION HYDROBROMIDE 522 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 0024-5824_ba10b6e3-b041-4437-ac9e-9b963c7b072a 0024-5824 HUMAN PRESCRIPTION DRUG Jevtana cabazitaxel KIT 20100617 NDA NDA201023 Sanofi-Aventis U.S. LLC N 20191231 0024-5840_31d60114-8140-4427-a086-ee306d3bc458 0024-5840 HUMAN PRESCRIPTION DRUG ZALTRAP ziv-aflibercept SOLUTION, CONCENTRATE INTRAVENOUS 20120803 BLA BLA125418 sanofi-aventis U.S. LLC AFLIBERCEPT 100 mg/4mL Vascular Endothelial Growth Factor Inhibitor [EPC],Vascular Endothelial Growth Factor Inhibitors [MoA] N 20181231 0024-5841_31d60114-8140-4427-a086-ee306d3bc458 0024-5841 HUMAN PRESCRIPTION DRUG ZALTRAP ziv-aflibercept SOLUTION, CONCENTRATE INTRAVENOUS 20120803 BLA BLA125418 sanofi-aventis U.S. LLC AFLIBERCEPT 200 mg/8mL Vascular Endothelial Growth Factor Inhibitor [EPC],Vascular Endothelial Growth Factor Inhibitors [MoA] N 20181231 0024-5843_aca63889-1042-411c-8cc1-f4d5c0ee4f44 0024-5843 HUMAN PRESCRIPTION DRUG Leukine SARGRAMOSTIM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 19910501 BLA BLA103362 sanofi-aventis U.S. LLC SARGRAMOSTIM 250 ug/mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] N 20181231 0024-5844_aca63889-1042-411c-8cc1-f4d5c0ee4f44 0024-5844 HUMAN PRESCRIPTION DRUG Leukine SARGRAMOSTIM LIQUID INTRAVENOUS; SUBCUTANEOUS 19961201 BLA BLA103362 sanofi-aventis U.S. LLC SARGRAMOSTIM 500 ug/mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] N 20181231 0024-5850_93df66af-a5f2-41eb-98d3-000f295b9967 0024-5850 HUMAN PRESCRIPTION DRUG Avapro irbesartan TABLET ORAL 20130101 NDA NDA020757 sanofi-aventis U.S. LLC IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0024-5851_93df66af-a5f2-41eb-98d3-000f295b9967 0024-5851 HUMAN PRESCRIPTION DRUG Avapro irbesartan TABLET ORAL 20130101 NDA NDA020757 sanofi-aventis U.S. LLC IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0024-5852_93df66af-a5f2-41eb-98d3-000f295b9967 0024-5852 HUMAN PRESCRIPTION DRUG Avapro irbesartan TABLET ORAL 20130101 NDA NDA020757 sanofi-aventis U.S. LLC IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0024-5855_5396d173-b323-49b5-b0ba-bf2e6a6e1967 0024-5855 HUMAN PRESCRIPTION DRUG Avalide irbesartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130101 NDA NDA020758 sanofi-aventis U.S. LLC IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0024-5856_5396d173-b323-49b5-b0ba-bf2e6a6e1967 0024-5856 HUMAN PRESCRIPTION DRUG Avalide irbesartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130101 NDA NDA020758 sanofi-aventis U.S. LLC IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0024-5860_6a52e3b2-71a8-407a-8a94-82fee239854b 0024-5860 HUMAN PRESCRIPTION DRUG Clolar clofarabine INJECTION INTRAVENOUS 20130401 NDA NDA021673 sanofi-aventis U.S. LLC CLOFARABINE 1 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0024-5862_acece200-9af8-4aee-aafe-2dea09fdc5b2 0024-5862 HUMAN PRESCRIPTION DRUG Mozobil PLERIXAFOR SOLUTION SUBCUTANEOUS 20130901 NDA NDA022311 sanofi-aventis U.S. LLC PLERIXAFOR 24 mg/1.2mL Hematopoietic Stem Cell Mobilizer [EPC],Increased Hematopoietic Stem Cell Mobilization [PE] N 20181231 0024-5869_d3fbaa04-d53c-4833-96b5-7688d4efbfb3 0024-5869 HUMAN PRESCRIPTION DRUG TOUJEO insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20150225 NDA NDA206538 Sanofi-Aventis U.S. LLC INSULIN GLARGINE 300 U/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0024-5901_27748799-89b9-4496-bbba-2c2f43889eb9 0024-5901 HUMAN PRESCRIPTION DRUG Praluent alirocumab INJECTION, SOLUTION SUBCUTANEOUS 20150724 BLA BLA125559 Sanofi-Aventis U.S. LLC ALIROCUMAB 75 mg/mL PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 0024-5902_27748799-89b9-4496-bbba-2c2f43889eb9 0024-5902 HUMAN PRESCRIPTION DRUG Praluent alirocumab INJECTION, SOLUTION SUBCUTANEOUS 20150724 BLA BLA125559 Sanofi-Aventis U.S. LLC ALIROCUMAB 150 mg/mL PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 0024-5903_27748799-89b9-4496-bbba-2c2f43889eb9 0024-5903 HUMAN PRESCRIPTION DRUG Praluent alirocumab INJECTION, SOLUTION SUBCUTANEOUS 20150724 BLA BLA125559 Sanofi-Aventis U.S. LLC ALIROCUMAB 75 mg/mL PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 0024-5904_27748799-89b9-4496-bbba-2c2f43889eb9 0024-5904 HUMAN PRESCRIPTION DRUG Praluent alirocumab INJECTION, SOLUTION SUBCUTANEOUS 20150724 BLA BLA125559 Sanofi-Aventis U.S. LLC ALIROCUMAB 150 mg/mL PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 0024-5908_322dfe38-b3af-4520-8e38-b45d992ea7c1 0024-5908 HUMAN PRESCRIPTION DRUG KEVZARA sarilumab INJECTION, SOLUTION SUBCUTANEOUS 20170522 BLA BLA761037 sanofi-aventis U.S. LLC SARILUMAB 150 mg/1.14mL Interleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC] N 20181231 0024-5910_322dfe38-b3af-4520-8e38-b45d992ea7c1 0024-5910 HUMAN PRESCRIPTION DRUG KEVZARA sarilumab INJECTION, SOLUTION SUBCUTANEOUS 20170522 BLA BLA761037 sanofi-aventis U.S. LLC SARILUMAB 200 mg/1.14mL Interleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC] N 20181231 0024-5914_e23c3c02-6f3f-425f-925a-781b74e979bc 0024-5914 HUMAN PRESCRIPTION DRUG Dupixent Dupilumab INJECTION, SOLUTION SUBCUTANEOUS 20170328 BLA BLA761055 sanofi-aventis U.S. LLC DUPILUMAB 300 mg/2mL Interleukin-4 Receptor alpha Antagonist [EPC],Interleukin 4 Receptor alpha Antagonists [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 0024-5916_e23c3c02-6f3f-425f-925a-781b74e979bc 0024-5916 HUMAN PRESCRIPTION DRUG Dupixent Dupilumab INJECTION, SOLUTION SUBCUTANEOUS 20170328 BLA BLA761055 sanofi-aventis U.S. LLC DUPILUMAB 300 mg/2mL Interleukin-4 Receptor alpha Antagonist [EPC],Interleukin 4 Receptor alpha Antagonists [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 0024-5917_e1373b20-fc33-4690-8811-cfe6c7f3af96 0024-5917 HUMAN PRESCRIPTION DRUG Clolar clofarabine INJECTION INTRAVENOUS 20170701 NDA NDA021673 sanofi-aventis U.S. LLC CLOFARABINE 1 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0024-5924_4b9b39be-5986-4bca-8294-d03f19490110 0024-5924 HUMAN PRESCRIPTION DRUG ADMELOG insulin lispro INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20171211 NDA NDA209196 Sanofi-Aventis U.S. LLC INSULIN LISPRO 100 U/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20191231 0024-5925_4b9b39be-5986-4bca-8294-d03f19490110 0024-5925 HUMAN PRESCRIPTION DRUG ADMELOG insulin lispro INJECTION, SOLUTION SUBCUTANEOUS 20171211 NDA NDA209196 Sanofi-Aventis U.S. LLC INSULIN LISPRO 100 U/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20191231 0025-0061_9f575923-9a60-40e7-8033-4903df487d77 0025-0061 HUMAN PRESCRIPTION DRUG Lomotil diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19600915 NDA NDA012462 G.D. Searle LLC Division of Pfizer Inc DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 0025-0166_9d1942e9-84e1-4db4-9948-d983a546cdaf 0025-0166 HUMAN PRESCRIPTION DRUG Synarel nafarelin acetate SPRAY, METERED NASAL 19900213 NDA NDA019886 G.D. Searle LLC Division of Pfizer Inc NAFARELIN ACETATE 2 mg/mL Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] N 20181231 0025-1001_609553a1-1ebc-497b-8c95-77ad2346b1ad 0025-1001 HUMAN PRESCRIPTION DRUG Aldactone spironolactone TABLET, FILM COATED ORAL 19600121 NDA NDA012151 G.D. Searle LLC Division of Pfizer Inc SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0025-1011_39c8d364-9df4-42ef-8e59-a792691f02f2 0025-1011 HUMAN PRESCRIPTION DRUG ALDACTAZIDE spironolactone and hydrochlorothiazide TABLET, FILM COATED ORAL 19780101 NDA NDA012616 G.D. Searle LLC Division of Pfizer Inc SPIRONOLACTONE; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0025-1021_39c8d364-9df4-42ef-8e59-a792691f02f2 0025-1021 HUMAN PRESCRIPTION DRUG ALDACTAZIDE spironolactone and hydrochlorothiazide TABLET, FILM COATED ORAL 19780101 NDA NDA012616 G.D. Searle LLC Division of Pfizer Inc SPIRONOLACTONE; HYDROCHLOROTHIAZIDE 50; 50 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0025-1031_609553a1-1ebc-497b-8c95-77ad2346b1ad 0025-1031 HUMAN PRESCRIPTION DRUG Aldactone spironolactone TABLET, FILM COATED ORAL 19600121 NDA NDA012151 G.D. Searle LLC Division of Pfizer Inc SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0025-1041_609553a1-1ebc-497b-8c95-77ad2346b1ad 0025-1041 HUMAN PRESCRIPTION DRUG Aldactone spironolactone TABLET, FILM COATED ORAL 19600121 NDA NDA012151 G.D. Searle LLC Division of Pfizer Inc SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0025-1381_4ee23434-7089-4cb2-8c7b-e7082ee01b5c 0025-1381 HUMAN PRESCRIPTION DRUG Daypro oxaprozin TABLET, FILM COATED ORAL 19921029 NDA NDA018841 G.D. Searle LLC Division of Pfizer Inc OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 0025-1411_33928d44-f279-41ab-a3e9-210d78240f63 0025-1411 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 19971224 NDA NDA020607 G.D. Searle LLC Division of Pfizer Inc DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 0025-1421_33928d44-f279-41ab-a3e9-210d78240f63 0025-1421 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 19971224 NDA NDA020607 G.D. Searle LLC Division of Pfizer Inc DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 0025-1451_9a73f122-b428-4185-b106-f28cbda767cd 0025-1451 HUMAN PRESCRIPTION DRUG Cytotec misoprostol TABLET ORAL 19861227 NDA NDA019268 G.D. Searle LLC Division of Pfizer Inc MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 0025-1461_9a73f122-b428-4185-b106-f28cbda767cd 0025-1461 HUMAN PRESCRIPTION DRUG Cytotec misoprostol TABLET ORAL 19861227 NDA NDA019268 G.D. Searle LLC Division of Pfizer Inc MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 0025-1515_8f311e45-85a2-44c6-96ee-6e7bdfbfa6b8 0025-1515 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 G.D. Searle LLC Division of Pfizer Inc CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0025-1520_8f311e45-85a2-44c6-96ee-6e7bdfbfa6b8 0025-1520 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 G.D. Searle LLC Division of Pfizer Inc CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0025-1525_8f311e45-85a2-44c6-96ee-6e7bdfbfa6b8 0025-1525 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 G.D. Searle LLC Division of Pfizer Inc CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0025-1530_8f311e45-85a2-44c6-96ee-6e7bdfbfa6b8 0025-1530 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 G.D. Searle LLC Division of Pfizer Inc CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0025-1710_feacab8c-ea58-4552-8c99-811905f17aa1 0025-1710 HUMAN PRESCRIPTION DRUG Inspra eplerenone TABLET, FILM COATED ORAL 20020927 NDA NDA021437 G.D. Searle LLC Division of Pfizer Inc EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0025-1720_feacab8c-ea58-4552-8c99-811905f17aa1 0025-1720 HUMAN PRESCRIPTION DRUG Inspra eplerenone TABLET, FILM COATED ORAL 20020927 NDA NDA021437 G.D. Searle LLC Division of Pfizer Inc EPLERENONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0025-1821_af803539-f500-43fa-badc-c1afea501926 0025-1821 HUMAN PRESCRIPTION DRUG Flagyl Metronidazole TABLET, FILM COATED ORAL 19630718 NDA NDA012623 G.D. Searle LLC Division of Pfizer Inc METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0025-1831_af803539-f500-43fa-badc-c1afea501926 0025-1831 HUMAN PRESCRIPTION DRUG Flagyl Metronidazole TABLET, FILM COATED ORAL 19630718 NDA NDA012623 G.D. Searle LLC Division of Pfizer Inc METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0025-1851_095836fe-9df4-4d9a-80af-de912e69f193 0025-1851 HUMAN PRESCRIPTION DRUG CALAN verapamil hydrochloride TABLET, FILM COATED ORAL 19840910 NDA NDA018817 G.D. Searle LLC Division of Pfizer Inc VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0025-1861_095836fe-9df4-4d9a-80af-de912e69f193 0025-1861 HUMAN PRESCRIPTION DRUG CALAN verapamil hydrochloride TABLET, FILM COATED ORAL 19840910 NDA NDA018817 G.D. Searle LLC Division of Pfizer Inc VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0025-1891_b5790ccd-b4bf-4878-8174-9c23b8b5852e 0025-1891 HUMAN PRESCRIPTION DRUG CALAN SR verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19861216 NDA NDA019152 G.D. Searle LLC Division of Pfizer Inc VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0025-1901_b5790ccd-b4bf-4878-8174-9c23b8b5852e 0025-1901 HUMAN PRESCRIPTION DRUG CALAN SR verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19910306 NDA NDA019152 G.D. Searle LLC Division of Pfizer Inc VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0025-1911_b5790ccd-b4bf-4878-8174-9c23b8b5852e 0025-1911 HUMAN PRESCRIPTION DRUG CALAN SR verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19891215 NDA NDA019152 G.D. Searle LLC Division of Pfizer Inc VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0025-1942_3d59eb5e-2769-401d-a42a-83fe8cbd2f98 0025-1942 HUMAN PRESCRIPTION DRUG Flagyl metronidazole CAPSULE ORAL 19950503 NDA NDA020334 G.D. Searle LLC Division of Pfizer Inc METRONIDAZOLE 375 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0025-2732_234e0244-3072-4717-9de9-026d6e1f0642 0025-2732 HUMAN PRESCRIPTION DRUG Norpace CR disopyramide phosphate CAPSULE, EXTENDED RELEASE ORAL 19820720 NDA NDA018655 G.D. Searle LLC Division of Pfizer Inc DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 0025-2742_234e0244-3072-4717-9de9-026d6e1f0642 0025-2742 HUMAN PRESCRIPTION DRUG Norpace CR disopyramide phosphate CAPSULE, EXTENDED RELEASE ORAL 19820720 NDA NDA018655 G.D. Searle LLC Division of Pfizer Inc DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 0025-2752_234e0244-3072-4717-9de9-026d6e1f0642 0025-2752 HUMAN PRESCRIPTION DRUG Norpace disopyramide phosphate CAPSULE, GELATIN COATED ORAL 19770901 NDA NDA017447 G.D. Searle LLC Division of Pfizer Inc DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 0025-2762_234e0244-3072-4717-9de9-026d6e1f0642 0025-2762 HUMAN PRESCRIPTION DRUG Norpace disopyramide phosphate CAPSULE, GELATIN COATED ORAL 19770901 NDA NDA017447 G.D. Searle LLC Division of Pfizer Inc DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 0026-3782_8e2e96c3-5e01-4a74-89ec-7426eafd8432 0026-3782 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20130626 BLA BLA103332 Bayer HealthCare LLC N 20191231 0026-3783_8e2e96c3-5e01-4a74-89ec-7426eafd8432 0026-3783 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20130626 BLA BLA103332 Bayer HealthCare LLC N 20191231 0026-3785_8e2e96c3-5e01-4a74-89ec-7426eafd8432 0026-3785 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20130626 BLA BLA103332 Bayer HealthCare LLC N 20191231 0026-3786_8e2e96c3-5e01-4a74-89ec-7426eafd8432 0026-3786 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20130626 BLA BLA103332 Bayer HealthCare LLC N 20191231 0026-3787_8e2e96c3-5e01-4a74-89ec-7426eafd8432 0026-3787 PLASMA DERIVATIVE Kogenate FS Antihemophilic Factor (Recombinant) KIT 20130626 BLA BLA103332 Bayer HealthCare LLC N 20191231 0026-3821_e244d1ff-98a4-4c2c-a3a9-9b23aa40f109 0026-3821 PLASMA DERIVATIVE Kovaltry Antihemophilic Factor (Recombinant) KIT 20160317 BLA BLA125574 Bayer HealthCare LLC N 20181231 0026-3822_e244d1ff-98a4-4c2c-a3a9-9b23aa40f109 0026-3822 PLASMA DERIVATIVE Kovaltry Antihemophilic Factor (Recombinant) KIT 20160317 BLA BLA125574 Bayer HealthCare LLC N 20181231 0026-3824_e244d1ff-98a4-4c2c-a3a9-9b23aa40f109 0026-3824 PLASMA DERIVATIVE Kovaltry Antihemophilic Factor (Recombinant) KIT 20160317 BLA BLA125574 Bayer HealthCare LLC N 20181231 0026-3826_e244d1ff-98a4-4c2c-a3a9-9b23aa40f109 0026-3826 PLASMA DERIVATIVE Kovaltry Antihemophilic Factor (Recombinant) KIT 20160317 BLA BLA125574 Bayer HealthCare LLC N 20181231 0026-3828_e244d1ff-98a4-4c2c-a3a9-9b23aa40f109 0026-3828 PLASMA DERIVATIVE Kovaltry Antihemophilic Factor (Recombinant) KIT 20160317 BLA BLA125574 Bayer HealthCare LLC N 20181231 0029-1526_87d918ac-d06c-47ee-8e88-fd7e81fea513 0029-1526 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin calcium OINTMENT TOPICAL 19960410 NDA NDA050703 GlaxoSmithKline LLC MUPIROCIN CALCIUM 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 0029-1527_2e79be7c-78c8-4f11-bcc5-1fc05bfffe75 0029-1527 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin calcium CREAM TOPICAL 19980123 NDA NDA050746 GlaxoSmithKline LLC MUPIROCIN CALCIUM 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 0031-2234_4d975f93-20f1-486d-b57d-8555f5e36e46 0031-2234 HUMAN OTC DRUG CHILDRENS DIMETAPP COLD AND COUGH brompheniramine maleate, dextromethorphan HBr, phenylephrine HCl LIQUID ORAL 20060523 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 0031-2235_67764bf0-af50-4689-8f4a-7fc2d8687dc2 0031-2235 HUMAN OTC DRUG CHILDRENS DIMETAPP COLD AND ALLERGY brompheniramine maleate, phenylephrine HCl LIQUID ORAL 20070207 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL N 20181231 0031-2238_059a3e6e-ea98-b0c5-ba27-b7cbbdedc917 0031-2238 HUMAN OTC DRUG CHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD chlorpheniramine maleate, dextromethorphan HBr LIQUID ORAL 20050304 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 1; 7.5 mg/mL; mg/5mL N 20181231 0031-2247_04a7f8bc-3d81-569e-7c7d-9c276a497072 0031-2247 HUMAN OTC DRUG CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION diphenhydramine HCl, phenylephrine HCl LIQUID ORAL 20071101 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth LLC, a subsidiary of Pfizer Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 0031-2249_bc20445e-2f92-432e-9677-095369ffe3ee 0031-2249 HUMAN OTC DRUG Childrens Dimetapp Multi-Symptom Cold and Flu acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride LIQUID ORAL 20140701 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 320; 12.5; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 0031-2295_f5eb7058-3396-4ba1-b2ed-31b9e3745e5f 0031-2295 HUMAN OTC DRUG Childrens Dimetapp Multi-Symptom Cold Relief Dye-Free brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl SOLUTION ORAL 20160601 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 0031-8649_ab8a877b-879d-4dd2-be2f-d6e14f447022 0031-8649 HUMAN OTC DRUG Robitussin Medi-Soothers Cough DM dextromethorphan hydrobromide and menthol LOZENGE ORAL 20140901 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL, UNSPECIFIED FORM 5; 5 mg/1; mg/1 N 20181231 0031-8655_adf0f894-ec19-49ea-8ee4-061e14ab22bd 0031-8655 HUMAN OTC DRUG Robitussin 12 Hour Cough Relief dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150701 ANDA ANDA091135 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 0031-8692_642899c4-4322-408e-aa1d-33ab66cb4613 0031-8692 HUMAN OTC DRUG Childrens Robitussin Nighttime Cough Long-Acting DM chlorpheniramine maleate, dextromethorphan hydrobromide SOLUTION ORAL 20140701 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 2; 15 mg/10mL; mg/10mL N 20181231 0031-8693_becb4025-b63e-f2ea-9d11-d51fdf4e5c13 0031-8693 HUMAN OTC DRUG CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING chlorpheniramine maleate, dextrometrorphan HBr LIQUID ORAL 20040101 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 1; 7.5 mg/5mL; mg/5mL N 20181231 0031-8694_6825904c-3eb9-400f-9c58-dba76cb108d5 0031-8694 HUMAN OTC DRUG Childrens Robitussin Cough Long-Acting dextromethorphan hydrobromide LIQUID ORAL 20040101 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg/5mL N 20181231 0031-8712_eac4dd2a-959b-1214-f17c-70cb896f9f48 0031-8712 HUMAN OTC DRUG ROBITUSSIN TO GO COUGH AND CHEST CONGESTION DM dextromethorphan HBr, guaifenesin LIQUID ORAL 20070731 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 2; 20 mg/mL; mg/mL N 20181231 0031-8713_55f6e151-92cf-438a-8272-47aaa9b761bc 0031-8713 HUMAN OTC DRUG ROBITUSSIN TO GO COUGH AND COLD CF dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20080107 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 0031-8715_2339a569-7c5f-4a8e-80e5-037eca03240a 0031-8715 HUMAN OTC DRUG Childrens Robitussin Cough and Chest Congestion DM dextromethorphan hydrobromide, guaifenesin LIQUID ORAL 20140701 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 0031-8716_dfc8529c-e381-41db-a702-67ca548c3be7 0031-8716 HUMAN OTC DRUG Childrens Robitussin Cough and Cold CF dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride LIQUID ORAL 20090901 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 0031-8717_7957def3-7e2d-426e-918c-38cf16f47c22 0031-8717 HUMAN OTC DRUG Robitussin Maximum Strength Nighttime Cough DM DEXTROMETHORPHAN HYDROBROMIDE and DOXYLAMINE SUCCINATE LIQUID ORAL 20130301 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL N 20181231 0031-8718_542f2c29-a567-4776-aeb6-451f613d0cb9 0031-8718 HUMAN OTC DRUG Robitussin Maximum Strength Nighttime Cough DM dextromethorphan hydrobromide, doxylamine succinate SOLUTION ORAL 20160601 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/20mL; mg/20mL N 20181231 0031-8719_50cf5ade-1f3e-43a2-adaf-1d4a305b5215 0031-8719 HUMAN OTC DRUG Robitussin Maximum Strength Cough Plus Chest Congestion DM dextromethorphan hydrobromide and guaifenesin CAPSULE, LIQUID FILLED ORAL 20130523 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 N 20181231 0031-8721_95223329-9780-4950-ac4d-8de865d31432 0031-8721 HUMAN OTC DRUG ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20120415 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0031-8722_bd07047f-e2b7-4784-86db-24994b4c12dc 0031-8722 HUMAN OTC DRUG ROBITUSSIN PEAK COLD NIGHTTIME COLD PLUS FLU Acetaminophen, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20120415 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 0031-8724_79db3cc6-0367-4120-9b42-68ff68b0e807 0031-8724 HUMAN OTC DRUG Robitussin Mucus Plus Chest Congestion Guaifenesin LIQUID ORAL 20120718 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth GUAIFENESIN 200 mg/10mL N 20181231 0031-8725_b75af3dd-1e38-4ce2-99c0-73a7267727a7 0031-8725 HUMAN OTC DRUG Childrens Robitussin 12 Hour Cough Relief dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20160705 ANDA ANDA091135 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 0031-8726_b75af3dd-1e38-4ce2-99c0-73a7267727a7 0031-8726 HUMAN OTC DRUG Childrens Robitussin 12 Hour Cough Relief dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20160705 ANDA ANDA091135 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 0031-8731_3f5205c9-9029-3555-0993-e19624354ada 0031-8731 HUMAN OTC DRUG ROBITUSSIN PEAK COLD NASAL RELIEF acetaminophen, phenylephrine HCl TABLET ORAL 20110606 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 0031-8732_8140f56b-469c-d437-b26b-d5d9517a8829 0031-8732 HUMAN OTC DRUG ROBITUSSIN PEAK COLD NIGHTTIME NASAL RELIEF acetaminophen, chlorpheniramine maleate, phenylephrine HCl TABLET ORAL 20110606 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 0031-8734_1b7e5948-97dc-a4ae-e545-2c8adb0e4003 0031-8734 HUMAN OTC DRUG ROBITUSSIN PEAK COLD MAXIMUM STRENGTH MULTI-SYMPTOM COLD dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20110615 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 0031-8735_06753c55-eac0-9317-b80f-714989238eca 0031-8735 HUMAN OTC DRUG ROBITUSSIN PEAK COLD NIGHTTIME MULTI-SYMPTOM COLD acetaminophen, diphenhydramine HCl, phenylephrine HCl LIQUID ORAL 20110615 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 6.25; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 0031-8736_d20ad7d5-8371-4b87-b668-533adf2c6d8b 0031-8736 HUMAN OTC DRUG Robitussin Peak Cold Cough Plus Chest Congestion DM dextromethorphan hydrobromide and guaifenesin SOLUTION ORAL 20110615 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 0031-8737_d20ad7d5-8371-4b87-b668-533adf2c6d8b 0031-8737 HUMAN OTC DRUG Robitussin Peak Cold Sugar-Free Cough Plus Chest Congestion DM dextromethorphan hydrobromide and guaifenesin SOLUTION ORAL 20110615 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 0031-8738_165677e7-8b6e-4c64-8012-b786fec53bf1 0031-8738 HUMAN OTC DRUG ROBITUSSIN PEAK COLD MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM dextromethorphan hydrobromide, guaifenesin SOLUTION ORAL 20110615 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 0031-8739_c8475e99-011e-4a3a-88b4-aca3477fba41 0031-8739 HUMAN OTC DRUG ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM dextromethorphan hydrobromide, guaifenesin SOLUTION ORAL 20160601 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 0031-8740_03f9663b-f98d-b611-4c83-9c3b643e7a31 0031-8740 HUMAN OTC DRUG ROBITUSSIN LINGERING COLD LONG-ACTING COUGH dextromethorphan HBr LIQUID ORAL 20110615 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 0031-8741_e2441138-42ac-4201-8b80-a86c9afd5b8f 0031-8741 HUMAN OTC DRUG ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS dextromethorphan hbr CAPSULE, LIQUID FILLED ORAL 20110606 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 0031-8742_5cc98f97-8f38-43ee-b3ab-c6258384803e 0031-8742 HUMAN OTC DRUG Robitussin Peak Cold Multi-Symptom Cold dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride LIQUID ORAL 20110612 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 0031-8750_8a2f886c-5fac-42e6-a47e-d036ada6afff 0031-8750 HUMAN OTC DRUG Robitussin Maximum Strength Severe Cough Plus Sore Throat acetaminophen, dextromethorphan hydrobromide LIQUID ORAL 20170410 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 650; 20 mg/20mL; mg/20mL N 20181231 0031-8751_7f429c9f-e3a5-410c-817d-6fe106f16126 0031-8751 HUMAN OTC DRUG Robitussin Severe Multi-Symptom Cough Cold Flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride LIQUID ORAL 20150501 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 0031-8752_a0ce06c6-44b6-49ba-8ffd-cb20f232109d 0031-8752 HUMAN OTC DRUG Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride SOLUTION ORAL 20150701 OTC MONOGRAPH FINAL part341 Richmond Division of Wyeth ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 0031-8753_adf0f894-ec19-49ea-8ee4-061e14ab22bd 0031-8753 HUMAN OTC DRUG Robitussin 12 Hour Cough Relief dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150701 ANDA ANDA091135 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 0031-8754_adf0f894-ec19-49ea-8ee4-061e14ab22bd 0031-8754 HUMAN OTC DRUG Robitussin 12 Hour Cough Relief dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20160705 ANDA ANDA091135 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 0031-8755_adf0f894-ec19-49ea-8ee4-061e14ab22bd 0031-8755 HUMAN OTC DRUG Robitussin 12 Hour Cough Relief dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20160705 ANDA ANDA091135 Richmond Division of Wyeth DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 0032-1203_c1fc1c81-d34a-7baf-ba5c-48425e015fe1 0032-1203 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090430 NDA NDA020725 AbbVie Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 15000; 3000; 9500 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 0032-1206_c1fc1c81-d34a-7baf-ba5c-48425e015fe1 0032-1206 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20090430 NDA NDA020725 AbbVie Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 30000; 6000; 19000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 0032-1212_c1fc1c81-d34a-7baf-ba5c-48425e015fe1 0032-1212 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20090430 NDA NDA020725 AbbVie Inc. PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE 60000; 12000; 38000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 0032-1224_c1fc1c81-d34a-7baf-ba5c-48425e015fe1 0032-1224 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20090430 NDA NDA020725 AbbVie Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 24000; 76000; 120000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 0032-1708_6339e30d-a5d3-09b0-852a-84ef2e8c2a83 0032-1708 HUMAN PRESCRIPTION DRUG Prometrium Progesterone CAPSULE ORAL 20100730 20180930 NDA NDA019781 AbbVie Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 0032-1711_6339e30d-a5d3-09b0-852a-84ef2e8c2a83 0032-1711 HUMAN PRESCRIPTION DRUG Prometrium Progesterone CAPSULE ORAL 20100730 20180731 NDA NDA019781 AbbVie Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 0032-3016_c1fc1c81-d34a-7baf-ba5c-48425e015fe1 0032-3016 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20130314 NDA NDA020725 AbbVie Inc. PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE 36000; 180000; 114000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 0037-0022_90fd7e8f-c3ea-4843-a13c-32e2269843a5 0037-0022 HUMAN PRESCRIPTION DRUG sfRowasa Sulfite-Free Formulation mesalamine SUSPENSION RECTAL 20160329 NDA NDA019618 Meda Pharmaceuticals MESALAMINE 4 g/60mL Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0037-0066_25b355a1-136b-42d5-bc09-214387ac6784 0037-0066 HUMAN PRESCRIPTION DRUG Rowasa mesalamine SUSPENSION RECTAL 20160329 NDA NDA019618 Meda Pharmaceuticals MESALAMINE 4 g/60mL Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0037-0083_bbeb4b69-54f5-40e8-8c29-680d5fe02acd 0037-0083 HUMAN PRESCRIPTION DRUG PreferaOB plus DHA prenatal/postnatal multivitamin/multimineral KIT ORAL 20150201 UNAPPROVED DRUG OTHER MEDA Pharmaceuticals N 20181231 0037-0084_d8af88e4-06e1-41f4-9af1-f5bc9a254f67 0037-0084 HUMAN PRESCRIPTION DRUG PreferaOB Cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, d-, iron sucrose, heme iron polypeptide, potassium iodide, zinc oxide, sodium selenate, cupric sulfate TABLET, COATED ORAL 20150428 UNAPPROVED DRUG OTHER MEDA Pharmaceuticals CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; IRON SUCROSE; HEME IRON POLYPEPTIDE; POTASSIUM IODIDE; ZINC OXIDE; SODIUM SELENATE; CUPRIC SULFATE 400; 10; 1.5; 1.6; 17; 50; 1; 12; 30; 10; 28; 6; 250; 4.5; 65; .8 [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0037-0086_88559f4c-25b8-4db1-a840-ea8fd5ac2ab6 0037-0086 HUMAN PRESCRIPTION DRUG PreferaOB ONE ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, d-, iron sucrose, heme iron polypeptide, potassium iodide, zinc oxide, schizochytrium dha oil CAPSULE, LIQUID FILLED ORAL 20150428 UNAPPROVED DRUG OTHER MEDA Pharmaceuticals ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; IRON SUCROSE; HEME IRON POLYPEPTIDE; POTASSIUM IODIDE; ZINC OXIDE; SCHIZOCHYTRIUM DHA OIL 25; 400; 10; 17; 50; 1; 12; 30; 10; 22; 6; 175; 15; 200 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0037-0113_96204987-d16c-47c1-b424-b94c13e347b7 0037-0113 HUMAN PRESCRIPTION DRUG Butisol Sodium Butabarbital Sodium TABLET ORAL 19390801 NDA NDA000793 Meda Pharmaceuticals BUTABARBITAL SODIUM 30 mg/1 CIII N 20181231 0037-0243_98263b8c-1476-4df0-b663-f5cb946b2fd8 0037-0243 HUMAN PRESCRIPTION DRUG Astepro Azelastine Hydrochloride SPRAY, METERED NASAL 20091012 NDA NDA022203 Meda Pharmaceuticals Inc. AZELASTINE HYDROCHLORIDE 205.5 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0037-0245_5dcc069a-8179-4896-a1fe-2da45254a757 0037-0245 HUMAN PRESCRIPTION DRUG DYMISTA Azelastine Hydrochloride and Fluticasone Propionate SPRAY, METERED NASAL 20120501 NDA NDA202236 Meda Pharmaceuticals Inc. AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE 137; 50 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0037-0430_1f3aad90-0bde-11e1-be50-0800200c9a66 0037-0430 HUMAN PRESCRIPTION DRUG Felbatol felbamate TABLET ORAL 19930729 NDA NDA020189 Meda Pharmaceuticals Inc. FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0037-0431_1f3aad90-0bde-11e1-be50-0800200c9a66 0037-0431 HUMAN PRESCRIPTION DRUG Felbatol felbamate TABLET ORAL 19930729 NDA NDA020189 Meda Pharmaceuticals Inc. FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0037-0442_1f3aad90-0bde-11e1-be50-0800200c9a66 0037-0442 HUMAN PRESCRIPTION DRUG Felbatol felbamate SUSPENSION ORAL 19930729 NDA NDA020189 Meda Pharmaceuticals Inc. FELBAMATE 600 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0037-0678_11c11f0c-1a0e-45a9-98d8-1b521d6351c1 0037-0678 HUMAN PRESCRIPTION DRUG Gastrocrom cromolyn sodium LIQUID ORAL 20150501 NDA NDA020479 MEDA Pharmaceuticals CROMOLYN SODIUM 20 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 0037-1221_70568880-5589-40c0-88f8-1721eef4a8a0 0037-1221 HUMAN PRESCRIPTION DRUG Cesamet Nabilone CAPSULE ORAL 20100301 NDA NDA018677 Meda Pharmaceuticals Inc. NABILONE 1 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CII N 20181231 0037-2001_11d3b0ec-c660-439d-b823-e7047647c2e5 0037-2001 HUMAN PRESCRIPTION DRUG Soma Carisoprodol TABLET ORAL 19590701 NDA NDA011792 Meda Pharmaceuticals CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 0037-2250_11d3b0ec-c660-439d-b823-e7047647c2e5 0037-2250 HUMAN PRESCRIPTION DRUG Soma Carisoprodol TABLET ORAL 20070901 NDA NDA011792 Meda Pharmaceuticals CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 0037-3500_496d41cf-a858-45e5-a9c7-1a85eee7fd16 0037-3500 HUMAN PRESCRIPTION DRUG Demadex Torsemide TABLET ORAL 20150101 NDA NDA020136 Meda Pharmaceuticals TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0037-3505_496d41cf-a858-45e5-a9c7-1a85eee7fd16 0037-3505 HUMAN PRESCRIPTION DRUG Demadex Torsemide TABLET ORAL 20150101 NDA NDA020136 Meda Pharmaceuticals TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0037-3510_496d41cf-a858-45e5-a9c7-1a85eee7fd16 0037-3510 HUMAN PRESCRIPTION DRUG Demadex Torsemide TABLET ORAL 20150101 20190630 NDA NDA020136 Meda Pharmaceuticals TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0037-3520_496d41cf-a858-45e5-a9c7-1a85eee7fd16 0037-3520 HUMAN PRESCRIPTION DRUG Demadex Torsemide TABLET ORAL 20150101 20181130 NDA NDA020136 Meda Pharmaceuticals TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0037-4401_8afdaf40-dcb8-11e1-baf1-0002a5d5c51b 0037-4401 HUMAN PRESCRIPTION DRUG Depen Penicillamine TABLET ORAL 19781130 NDA NDA019854 Meda Pharmaceuticals Inc. PENICILLAMINE 250 mg/1 Antirheumatic Agent [EPC] N 20181231 0037-4801_19f65652-17d2-4272-b73c-e3acce868944 0037-4801 HUMAN PRESCRIPTION DRUG ELESTRIN ESTRADIOL GEL, METERED TOPICAL 20140602 NDA NDA021813 Meda Pharmaceuticals ESTRADIOL .52 mg/.87g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0037-4802_19f65652-17d2-4272-b73c-e3acce868944 0037-4802 HUMAN PRESCRIPTION DRUG ELESTRIN ESTRADIOL GEL, METERED TOPICAL 20140602 NDA NDA021813 Meda Pharmaceuticals ESTRADIOL .52 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0037-6010_d6e4d82e-fde4-468b-869e-081a18dd30c5 0037-6010 HUMAN PRESCRIPTION DRUG Edluar Zolpidem Tartrate TABLET ORAL 20090724 NDA NDA021997 Meda Pharmaceuticals ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20191231 0037-6050_d6e4d82e-fde4-468b-869e-081a18dd30c5 0037-6050 HUMAN PRESCRIPTION DRUG Edluar Zolpidem Tartrate TABLET ORAL 20090724 NDA NDA021997 Meda Pharmaceuticals ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20191231 0037-6072_7481aaf9-2cb5-42bb-b95c-e7027328c578 0037-6072 HUMAN PRESCRIPTION DRUG Natelle One doconexent, icosapent, calcium, iron, ascorbic acid, pyridoxine, .alpha.-tocopherol, folic acid CAPSULE, GELATIN COATED ORAL 20150201 UNAPPROVED DRUG OTHER MEDA Pharmaceuticals DOCONEXENT; ICOSAPENT; CALCIUM; IRON; ASCORBIC ACID; PYRIDOXINE; .ALPHA.-TOCOPHEROL; FOLIC ACID 250; .625; 102; 28; 30; 25; 30; 1 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0037-6321_37b31a99-1a32-4e7f-9363-7061e1a20019 0037-6321 HUMAN PRESCRIPTION DRUG URELLE hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate TABLET ORAL 20150112 UNAPPROVED DRUG OTHER Meda Pharmaceuticals Inc. HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .12; 81; 10.8; 32.4; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] E 20171231 0037-6631_17e55d0e-8126-4472-9333-d363612b422d 0037-6631 HUMAN PRESCRIPTION DRUG AVC sulfanilamide CREAM VAGINAL 20141201 NDA NDA006530 Meda Pharmaceuticals SULFANILAMIDE 15 g/100g N 20181231 0037-6820_ad34d2e0-1e98-11e4-8c21-0800200c9a66 0037-6820 HUMAN PRESCRIPTION DRUG COLYTE peg-3350 and electrolytes POWDER, FOR SOLUTION NASOGASTRIC 20140805 NDA NDA018983 MEDA Pharmaceuticals POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM SULFATE 240; 5.84; 2.98; 6.72; 22.72 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0037-6822_6881933a-d72c-4a9c-83e0-2b523b801020 0037-6822 HUMAN PRESCRIPTION DRUG PROCTOFOAM HC pramoxine hydrochloride hydrocortisone acetate AEROSOL, FOAM TOPICAL 20140815 ANDA ANDA086195 Meda Pharmaceuticals PRAMOXINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 100; 100 mg/10g; mg/10g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0037-6823_cddc8d80-21b8-11e4-8c21-0800200c9a66 0037-6823 HUMAN OTC DRUG PROCTOFOAM NS pramoxine hydrochloride AEROSOL, FOAM RECTAL 20140818 OTC MONOGRAPH FINAL part346 MEDA PHARMACEUTICALS INC. PRAMOXINE HYDROCHLORIDE 150 mg/15g N 20181231 0037-6824_b22b8b40-2f1e-11e4-8c21-0800200c9a66 0037-6824 HUMAN PRESCRIPTION DRUG EPIFOAM pramoxine hydrochloride and hydrocortisone acetate AEROSOL, FOAM TOPICAL 20140825 ANDA ANDA086457 MEDA Pharmaceuticals PRAMOXINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 100; 100 mg/10g; mg/10g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0037-6830_27acd0c3-12c4-484d-bcb4-08dfc6d21efc 0037-6830 HUMAN PRESCRIPTION DRUG Cortifoam hydrocortisone acetate AEROSOL, FOAM TOPICAL 20150615 NDA NDA017351 Meda Pharmaceuticals HYDROCORTISONE ACETATE 1500 mg/15g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0037-6860_43f6c437-5c6a-4171-893a-c5669a8fa082 0037-6860 HUMAN PRESCRIPTION DRUG Dipentum olsalazine sodium CAPSULE, GELATIN COATED ORAL 20150515 NDA NDA019715 MEDA Pharmaceuticals OLSALAZINE SODIUM 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0037-6885_3dbec270-2747-4c24-a288-9e80ba23ecd9 0037-6885 HUMAN PRESCRIPTION DRUG BiferaRx folic acid, cyanocobalamin, iron dextran and heme iron polypeptide TABLET ORAL 20121031 UNAPPROVED DRUG OTHER Meda Pharmaceuticals FOLIC ACID; CYANOCOBALAMIN; IRON DEXTRAN; HEME IRON POLYPEPTIDE 1; 25; 22; 6 mg/1; ug/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0037-7590_d2916d49-ffb6-40b5-ab7e-5cd5946c7335 0037-7590 HUMAN PRESCRIPTION DRUG Aerospan flunisolide AEROSOL, METERED RESPIRATORY (INHALATION) 20120301 NDA NDA021247 Meda Pharmaceuticals FLUNISOLIDE 80 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0037-8110_d932ddff-6f6d-4770-9e1c-155e80f87952 0037-8110 HUMAN PRESCRIPTION DRUG MUSE Alprostadil SUPPOSITORY URETHRAL 20110722 NDA NDA020700 Meda Pharmaceuticals ALPROSTADIL 125 ug/1 Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 0037-8120_d932ddff-6f6d-4770-9e1c-155e80f87952 0037-8120 HUMAN PRESCRIPTION DRUG MUSE Alprostadil SUPPOSITORY URETHRAL 20110722 NDA NDA020700 Meda Pharmaceuticals ALPROSTADIL 250 ug/1 Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 0037-8130_d932ddff-6f6d-4770-9e1c-155e80f87952 0037-8130 HUMAN PRESCRIPTION DRUG MUSE Alprostadil SUPPOSITORY URETHRAL 20110722 NDA NDA020700 Meda Pharmaceuticals ALPROSTADIL 500 ug/1 Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 0037-8140_d932ddff-6f6d-4770-9e1c-155e80f87952 0037-8140 HUMAN PRESCRIPTION DRUG MUSE Alprostadil SUPPOSITORY URETHRAL 20110722 NDA NDA020700 Meda Pharmaceuticals ALPROSTADIL 1000 ug/1 Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 0037-9001_d11e402c-c7a8-4252-bc56-f78acb75b74c 0037-9001 HUMAN PRESCRIPTION DRUG Levsin HYOSCYAMINE SULFATE INJECTION, SOLUTION SUBCUTANEOUS 20081201 UNAPPROVED DRUG OTHER Meda Pharmaceuticals HYOSCYAMINE SULFATE .5 mg/mL N 20181231 0039-0051_4c824136-526b-434d-be05-2489719d61dc 0039-0051 HUMAN PRESCRIPTION DRUG DiaBeta glyburide TABLET ORAL 20090601 NDA NDA017532 Sanofi-Aventis U.S. LLC GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0039-0052_4c824136-526b-434d-be05-2489719d61dc 0039-0052 HUMAN PRESCRIPTION DRUG DiaBeta glyburide TABLET ORAL 20090601 NDA NDA017532 Sanofi-Aventis U.S. LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0039-0053_4c824136-526b-434d-be05-2489719d61dc 0039-0053 HUMAN PRESCRIPTION DRUG DiaBeta glyburide TABLET ORAL 20090601 NDA NDA017532 Sanofi-Aventis U.S. LLC GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0039-0060_0980536d-7652-41a6-a618-8a708d9ac695 0039-0060 HUMAN PRESCRIPTION DRUG Lasix furosemide TABLET ORAL 19660701 NDA NDA016273 Sanofi-Aventis U.S. LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 0039-0066_0980536d-7652-41a6-a618-8a708d9ac695 0039-0066 HUMAN PRESCRIPTION DRUG Lasix furosemide TABLET ORAL 19660701 NDA NDA016273 Sanofi-Aventis U.S. LLC FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 0039-0067_0980536d-7652-41a6-a618-8a708d9ac695 0039-0067 HUMAN PRESCRIPTION DRUG Lasix furosemide TABLET ORAL 19660701 NDA NDA016273 Sanofi-Aventis U.S. LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 0039-0221_0a72ac3f-1575-4315-9032-77f830666649 0039-0221 HUMAN PRESCRIPTION DRUG AMARYL glimepiride TABLET ORAL 20090618 NDA NDA020496 Sanofi-Aventis U.S. LLC GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 0039-0222_0a72ac3f-1575-4315-9032-77f830666649 0039-0222 HUMAN PRESCRIPTION DRUG AMARYL glimepiride TABLET ORAL 20090618 NDA NDA020496 Sanofi-Aventis U.S. LLC GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 0039-0223_0a72ac3f-1575-4315-9032-77f830666649 0039-0223 HUMAN PRESCRIPTION DRUG AMARYL glimepiride TABLET ORAL 20090618 NDA NDA020496 Sanofi-Aventis U.S. LLC GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 0041-0241_d2619d49-23ad-49d4-b73c-6add34d237f5 0041-0241 HUMAN PRESCRIPTION DRUG Oral-B NeutraCare Mint Neutral Sodium Fluoride GEL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 11 mg/g E 20171231 0041-0340_127fdd22-f93e-49f6-86fe-beaa3a2e413b 0041-0340 HUMAN PRESCRIPTION DRUG Oral-B Minute-Foam Banana Splitz Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 10 mg/g E 20171231 0041-0341_c5c2aabe-1929-4388-bfd4-63ea48385792 0041-0341 HUMAN PRESCRIPTION DRUG Oral-B Minute-Foam Mellow Mint Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 10 mg/g E 20171231 0041-0342_d02a95f1-c32d-4b91-87f6-45fff1cefea2 0041-0342 HUMAN PRESCRIPTION DRUG Oral-B Minute-Foam Orang-A-Tangy Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE; HYDROFLUORIC ACID 10; 2.3 mg/g; mg/g E 20171231 0041-0345_cbc81e44-7ce5-4827-b478-44614f591735 0041-0345 HUMAN PRESCRIPTION DRUG Oral-B Minute-Foam Bubble Gum Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 10 mg/g E 20171231 0041-0346_e0762a31-0020-4991-8ac6-76f16518a5be 0041-0346 HUMAN PRESCRIPTION DRUG Oral-B Minute-Foam Strawberry Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 10 mg/g E 20171231 0041-0347_d4818be4-8820-43b1-86bd-becae2b54e91 0041-0347 HUMAN PRESCRIPTION DRUG Oral-B Minute-Foam Grape Punch Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 10 mg/g E 20171231 0041-0348_c2e54b0c-64bc-4a0d-9a23-925f4e039441 0041-0348 HUMAN PRESCRIPTION DRUG Oral-B Neutra-Foam Mint Neutral Sodium Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Oral-B Laboratories SODIUM FLUORIDE 9 mg/g E 20171231 0041-1420_fdb37c8d-9768-4e34-a17a-27124a0895ca 0041-1420 HUMAN OTC DRUG Oral-B Anti-Bacterial Cetylpyridinium Chloride LIQUID DENTAL 20051015 OTC MONOGRAPH NOT FINAL part356 Oral-B Laboratories CETYLPYRIDINIUM CHLORIDE 500 ug/mL E 20171231 0041-1421_64705480-a0f6-4765-8dc4-7ae64816d3a4 0041-1421 HUMAN OTC DRUG Oral-B Anticavity Sodium Fluoride LIQUID DENTAL 20051015 OTC MONOGRAPH NOT FINAL part355 Oral-B Laboratories SODIUM FLUORIDE 500 ug/mL E 20171231 0046-0749_7524cc62-1874-4acc-b708-e7b56d12d1db 0046-0749 HUMAN PRESCRIPTION DRUG Premarin CONJUGATED ESTROGENS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19561201 NDA NDA010402 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED 25 mg/5mL Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 0046-0872_f3cbcd64-1935-4b64-a387-ec0ef9598bce 0046-0872 HUMAN PRESCRIPTION DRUG Premarin Vaginal conjugated estrogens CREAM VAGINAL 19781101 NDA NDA020216 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED .625 mg/g Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 0046-1065_a5472ca8-d1b5-43fb-b168-a5bfe7f45dbe 0046-1065 HUMAN PRESCRIPTION DRUG Phospholine Iodide Ophthalmic echothiophate iodide KIT 19591204 NDA NDA011963 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 0046-1100_a835b4be-91a2-4fc9-9aba-7ef1309c75a9 0046-1100 HUMAN PRESCRIPTION DRUG Premarin estrogens, conjugated TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED .3 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 0046-1101_a835b4be-91a2-4fc9-9aba-7ef1309c75a9 0046-1101 HUMAN PRESCRIPTION DRUG Premarin estrogens, conjugated TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED .45 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 0046-1102_a835b4be-91a2-4fc9-9aba-7ef1309c75a9 0046-1102 HUMAN PRESCRIPTION DRUG Premarin estrogens, conjugated TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 0046-1103_a835b4be-91a2-4fc9-9aba-7ef1309c75a9 0046-1103 HUMAN PRESCRIPTION DRUG Premarin estrogens, conjugated TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED .9 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 0046-1104_a835b4be-91a2-4fc9-9aba-7ef1309c75a9 0046-1104 HUMAN PRESCRIPTION DRUG Premarin estrogens, conjugated TABLET, FILM COATED ORAL 20040901 NDA NDA004782 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED 1.25 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 0046-1105_2d772467-6aeb-469d-bdcb-5f57c9d98e37 0046-1105 HUMAN PRESCRIPTION DRUG Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE TABLET, SUGAR COATED ORAL 20090921 NDA NDA020527 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .3; 1.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20191231 0046-1106_2d772467-6aeb-469d-bdcb-5f57c9d98e37 0046-1106 HUMAN PRESCRIPTION DRUG Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE TABLET, SUGAR COATED ORAL 20090921 NDA NDA020527 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .45; 1.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20191231 0046-1107_2d772467-6aeb-469d-bdcb-5f57c9d98e37 0046-1107 HUMAN PRESCRIPTION DRUG Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE TABLET, SUGAR COATED ORAL 20090921 NDA NDA020527 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .625; 2.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20191231 0046-1108_2d772467-6aeb-469d-bdcb-5f57c9d98e37 0046-1108 HUMAN PRESCRIPTION DRUG Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE TABLET, SUGAR COATED ORAL 20121203 NDA NDA020527 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .625; 5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20191231 0046-2575_2d772467-6aeb-469d-bdcb-5f57c9d98e37 0046-2575 HUMAN PRESCRIPTION DRUG Premphase conjugated estrogens and medroxyprogesterone acetate KIT 20120301 NDA NDA020527 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20191231 0049-0013_fac9c6a5-af3b-45df-b130-346fcdc3f688 0049-0013 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 NDA NDA050608 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0049-0014_fac9c6a5-af3b-45df-b130-346fcdc3f688 0049-0014 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 NDA NDA050608 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0049-0022_fac9c6a5-af3b-45df-b130-346fcdc3f688 0049-0022 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 NDA NDA050608 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0049-0023_fac9c6a5-af3b-45df-b130-346fcdc3f688 0049-0023 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 NDA NDA050608 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0049-0024_2c7d9544-4200-4252-8252-94c5a0015898 0049-0024 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 NDA NDA050608 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0049-0031_fac9c6a5-af3b-45df-b130-346fcdc3f688 0049-0031 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 ANDA ANDA062901 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0049-0032_fac9c6a5-af3b-45df-b130-346fcdc3f688 0049-0032 HUMAN PRESCRIPTION DRUG UNASYN ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911122 ANDA ANDA062901 Roerig AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0049-0052_be57800c-6eca-466b-847b-bfd5f2efcc93 0049-0052 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20131101 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 0049-0054_be57800c-6eca-466b-847b-bfd5f2efcc93 0049-0054 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20131101 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 0049-0056_be57800c-6eca-466b-847b-bfd5f2efcc93 0049-0056 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20131101 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 0049-0058_be57800c-6eca-466b-847b-bfd5f2efcc93 0049-0058 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20131101 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 0049-0114_8ddbb33b-2525-4102-8d23-cd943ee4620f 0049-0114 HUMAN PRESCRIPTION DRUG ERAXIS anidulafungin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060217 NDA NDA021632 Roerig ANIDULAFUNGIN 50 mg/15mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20191231 0049-0116_8ddbb33b-2525-4102-8d23-cd943ee4620f 0049-0116 HUMAN PRESCRIPTION DRUG ERAXIS anidulafungin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060217 NDA NDA021632 Roerig ANIDULAFUNGIN 100 mg/30mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20191231 0049-0170_6a03e980-be02-49eb-ac59-e4512992fdb1 0049-0170 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 20130715 NDA NDA020329 Roerig GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0049-0174_6a03e980-be02-49eb-ac59-e4512992fdb1 0049-0174 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 20130509 NDA NDA020329 Roerig GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0049-0178_6a03e980-be02-49eb-ac59-e4512992fdb1 0049-0178 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 20130509 NDA NDA020329 Roerig GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0049-0520_a4def279-4743-4693-9def-0adbdb742768 0049-0520 HUMAN PRESCRIPTION DRUG Pfizerpen penicillin G potassium POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS 20100601 ANDA ANDA060657 Roerig PENICILLIN G POTASSIUM 5000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0049-0520_ac7a2e34-0305-4a7e-a9b0-2718fd7522bf 0049-0520 HUMAN PRESCRIPTION DRUG Pfizerpen penicillin G potassium POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRATHECAL; INTRAVENOUS 20100601 ANDA ANDA060657 Roerig PENICILLIN G POTASSIUM 5000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0049-0530_a4def279-4743-4693-9def-0adbdb742768 0049-0530 HUMAN PRESCRIPTION DRUG Pfizerpen penicillin G potassium POWDER, FOR SOLUTION INTRAVENOUS 20100601 ANDA ANDA060657 Roerig PENICILLIN G POTASSIUM 20000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0049-0530_ac7a2e34-0305-4a7e-a9b0-2718fd7522bf 0049-0530 HUMAN PRESCRIPTION DRUG Pfizerpen penicillin G potassium POWDER, FOR SOLUTION INTRAVENOUS 20100601 ANDA ANDA060657 Roerig PENICILLIN G POTASSIUM 20000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0049-1203_e14565ec-7453-4081-91ef-8764e7c9112f 0049-1203 HUMAN PRESCRIPTION DRUG Geodon ziprasidone mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20170724 NDA NDA020919 Roerig ZIPRASIDONE MESYLATE 20 mg/mL Atypical Antipsychotic [EPC] N 20181231 0049-2100_332740ec-d49a-4564-92fa-9446a131c20c 0049-2100 HUMAN PRESCRIPTION DRUG Antivert MECLIZINE HYDROCHLORIDE TABLET ORAL 19970411 NDA NDA010721 Roerig MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 0049-2110_332740ec-d49a-4564-92fa-9446a131c20c 0049-2110 HUMAN PRESCRIPTION DRUG Antivert MECLIZINE HYDROCHLORIDE TABLET ORAL 19970411 NDA NDA010721 Roerig MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 0049-2140_332740ec-d49a-4564-92fa-9446a131c20c 0049-2140 HUMAN PRESCRIPTION DRUG Antivert MECLIZINE HYDROCHLORIDE TABLET ORAL 19970411 NDA NDA010721 Roerig MECLIZINE HYDROCHLORIDE 50 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 0049-2330_75f3cdef-9123-4f32-8352-c54d67ac026d 0049-2330 HUMAN PRESCRIPTION DRUG Relpax eletriptan hydrobromide TABLET, FILM COATED ORAL 20021226 NDA NDA021016 Roerig ELETRIPTAN HYDROBROMIDE 20 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0049-2340_75f3cdef-9123-4f32-8352-c54d67ac026d 0049-2340 HUMAN PRESCRIPTION DRUG Relpax eletriptan hydrobromide TABLET, FILM COATED ORAL 20021226 NDA NDA021016 Roerig ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0049-2710_83f41071-e854-4659-a7d5-d3f43d247462 0049-2710 HUMAN PRESCRIPTION DRUG Cardura XL doxazosin mesylate TABLET, MULTILAYER, EXTENDED RELEASE ORAL 20050222 NDA NDA021269 Roerig DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 0049-2720_83f41071-e854-4659-a7d5-d3f43d247462 0049-2720 HUMAN PRESCRIPTION DRUG Cardura XL doxazosin mesylate TABLET, MULTILAYER, EXTENDED RELEASE ORAL 20050222 NDA NDA021269 Roerig DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 0049-2750_0a53d08b-8a14-4bb5-8b43-7510c18bc1b9 0049-2750 HUMAN PRESCRIPTION DRUG Cardura doxazosin mesylate TABLET ORAL 19901102 NDA NDA019668 Roerig DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0049-2760_0a53d08b-8a14-4bb5-8b43-7510c18bc1b9 0049-2760 HUMAN PRESCRIPTION DRUG Cardura doxazosin mesylate TABLET ORAL 19901102 NDA NDA019668 Roerig DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0049-2770_0a53d08b-8a14-4bb5-8b43-7510c18bc1b9 0049-2770 HUMAN PRESCRIPTION DRUG Cardura doxazosin mesylate TABLET ORAL 19901102 NDA NDA019668 Roerig DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0049-2780_0a53d08b-8a14-4bb5-8b43-7510c18bc1b9 0049-2780 HUMAN PRESCRIPTION DRUG Cardura doxazosin mesylate TABLET ORAL 19901102 NDA NDA019668 Roerig DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0049-3160_ddc1b249-37f4-4db9-8381-1856e447320a 0049-3160 HUMAN PRESCRIPTION DRUG VFEND voriconazole POWDER, FOR SUSPENSION ORAL 20030328 NDA NDA021630 Roerig VORICONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0049-3170_ddc1b249-37f4-4db9-8381-1856e447320a 0049-3170 HUMAN PRESCRIPTION DRUG VFEND voriconazole TABLET, FILM COATED ORAL 20030328 NDA NDA021266 Roerig VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0049-3180_ddc1b249-37f4-4db9-8381-1856e447320a 0049-3180 HUMAN PRESCRIPTION DRUG VFEND voriconazole TABLET, FILM COATED ORAL 20030328 NDA NDA021266 Roerig VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0049-3190_3324484a-bb37-436c-9ea5-d2e7d00d085d 0049-3190 HUMAN PRESCRIPTION DRUG VFEND voriconazole INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20121024 NDA NDA021267 Roerig VORICONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 0049-3190_89cf4497-7044-4ecf-adb5-6250ac45b8b6 0049-3190 HUMAN PRESCRIPTION DRUG VFEND Voriconazole INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20020524 NDA NDA021267 Roerig VORICONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 0049-3190_ddc1b249-37f4-4db9-8381-1856e447320a 0049-3190 HUMAN PRESCRIPTION DRUG VFEND voriconazole INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20030328 NDA NDA021267 Roerig VORICONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 0049-3410_840c490a-d97e-4b05-a607-e4f54e3084cb 0049-3410 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 19900129 NDA NDA019949 Roerig FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0049-3420_840c490a-d97e-4b05-a607-e4f54e3084cb 0049-3420 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 19900129 NDA NDA019949 Roerig FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0049-3430_840c490a-d97e-4b05-a607-e4f54e3084cb 0049-3430 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 19900129 NDA NDA019949 Roerig FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0049-3440_840c490a-d97e-4b05-a607-e4f54e3084cb 0049-3440 HUMAN PRESCRIPTION DRUG Diflucan fluconazole POWDER, FOR SUSPENSION ORAL 19931223 NDA NDA020090 Roerig FLUCONAZOLE 350 mg/35mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0049-3450_840c490a-d97e-4b05-a607-e4f54e3084cb 0049-3450 HUMAN PRESCRIPTION DRUG Diflucan fluconazole POWDER, FOR SUSPENSION ORAL 19931223 NDA NDA020090 Roerig FLUCONAZOLE 1400 mg/35mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0049-3500_840c490a-d97e-4b05-a607-e4f54e3084cb 0049-3500 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 19900129 NDA NDA019949 Roerig FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0049-3920_be57800c-6eca-466b-847b-bfd5f2efcc93 0049-3920 HUMAN PRESCRIPTION DRUG Geodon ziprasidone mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20031223 NDA NDA020919 Roerig ZIPRASIDONE MESYLATE 20 mg/mL Atypical Antipsychotic [EPC] N 20181231 0049-3960_be57800c-6eca-466b-847b-bfd5f2efcc93 0049-3960 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 0049-3970_be57800c-6eca-466b-847b-bfd5f2efcc93 0049-3970 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 0049-3980_be57800c-6eca-466b-847b-bfd5f2efcc93 0049-3980 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 0049-3990_be57800c-6eca-466b-847b-bfd5f2efcc93 0049-3990 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Roerig ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 0049-4110_76cc6cf8-06bb-440d-b2ca-5bc5fb770dd2 0049-4110 HUMAN PRESCRIPTION DRUG Glucotrol glipizide TABLET ORAL 19840508 NDA NDA017783 Roerig GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0049-4120_76cc6cf8-06bb-440d-b2ca-5bc5fb770dd2 0049-4120 HUMAN PRESCRIPTION DRUG Glucotrol glipizide TABLET ORAL 19840508 NDA NDA017783 Roerig GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0049-4190_ec7aaffb-5b59-4566-9af5-f795a88e4df4 0049-4190 HUMAN PRESCRIPTION DRUG VFEND VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20121024 NDA NDA021267 Roerig VORICONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0049-4900_97b77592-95b5-48bb-acab-b393783359a7 0049-4900 HUMAN PRESCRIPTION DRUG Zoloft sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Roerig SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0049-4910_97b77592-95b5-48bb-acab-b393783359a7 0049-4910 HUMAN PRESCRIPTION DRUG Zoloft sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Roerig SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0049-4940_97b77592-95b5-48bb-acab-b393783359a7 0049-4940 HUMAN PRESCRIPTION DRUG Zoloft sertraline hydrochloride SOLUTION, CONCENTRATE ORAL 19920211 NDA NDA020990 Roerig SERTRALINE HYDROCHLORIDE 20 mg/mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0049-4950_97b77592-95b5-48bb-acab-b393783359a7 0049-4950 HUMAN PRESCRIPTION DRUG Zoloft sertraline hydrochloride SOLUTION, CONCENTRATE ORAL 20170106 NDA NDA020990 Roerig SERTRALINE HYDROCHLORIDE 20 mg/mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0049-4960_97b77592-95b5-48bb-acab-b393783359a7 0049-4960 HUMAN PRESCRIPTION DRUG Zoloft sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Roerig SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0051-0021_d2e02917-4a63-33d3-30f6-bcb9c2f35381 0051-0021 HUMAN PRESCRIPTION DRUG Marinol Dronabinol CAPSULE ORAL 20100713 NDA NDA018651 AbbVie Inc. DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 0051-0022_d2e02917-4a63-33d3-30f6-bcb9c2f35381 0051-0022 HUMAN PRESCRIPTION DRUG Marinol Dronabinol CAPSULE ORAL 20100713 NDA NDA018651 AbbVie Inc. DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 0051-0023_d2e02917-4a63-33d3-30f6-bcb9c2f35381 0051-0023 HUMAN PRESCRIPTION DRUG Marinol Dronabinol CAPSULE ORAL 20100713 NDA NDA018651 AbbVie Inc. DRONABINOL 10 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 0051-8425_77628024-c27e-77a4-a8a5-78bbc82a0f25 0051-8425 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20110314 NDA NDA021015 AbbVie Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0051-8450_77628024-c27e-77a4-a8a5-78bbc82a0f25 0051-8450 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20110314 NDA NDA021015 AbbVie Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0051-8462_0427d8a7-524c-6885-b5fc-9ebf01f5e4df 0051-8462 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20110429 NDA NDA022309 AbbVie Inc. TESTOSTERONE 16.2 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0052-0105_33fd5983-f561-4c9a-9913-b773f4f3da21 0052-0105 HUMAN PRESCRIPTION DRUG REMERON MIRTAZAPINE TABLET, FILM COATED ORAL 19960614 NDA NDA020415 Organon USA Inc. MIRTAZAPINE 15 mg/1 N 20191231 0052-0106_b020ff0d-6072-432c-83a2-0b7c21c649c4 0052-0106 HUMAN PRESCRIPTION DRUG REMERONSOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20010112 NDA NDA021208 Organon USA Inc. MIRTAZAPINE 15 mg/1 N 20191231 0052-0107_33fd5983-f561-4c9a-9913-b773f4f3da21 0052-0107 HUMAN PRESCRIPTION DRUG REMERON MIRTAZAPINE TABLET, FILM COATED ORAL 19960614 NDA NDA020415 Organon USA Inc. MIRTAZAPINE 30 mg/1 N 20191231 0052-0108_b020ff0d-6072-432c-83a2-0b7c21c649c4 0052-0108 HUMAN PRESCRIPTION DRUG REMERONSOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20010112 NDA NDA021208 Organon USA Inc. MIRTAZAPINE 30 mg/1 N 20191231 0052-0109_33fd5983-f561-4c9a-9913-b773f4f3da21 0052-0109 HUMAN PRESCRIPTION DRUG REMERON MIRTAZAPINE TABLET, FILM COATED ORAL 19970311 NDA NDA020415 Organon USA Inc. MIRTAZAPINE 45 mg/1 N 20191231 0052-0110_b020ff0d-6072-432c-83a2-0b7c21c649c4 0052-0110 HUMAN PRESCRIPTION DRUG REMERONSOLTAB MIRTAZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20010112 NDA NDA021208 Organon USA Inc. MIRTAZAPINE 45 mg/1 N 20191231 0052-0118_da55e2fe-c473-46cc-a4b4-d31c8e63d148 0052-0118 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20090813 NDA NDA022117 Organon Pharmaceuticals USA ASENAPINE MALEATE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0052-0119_da55e2fe-c473-46cc-a4b4-d31c8e63d148 0052-0119 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20090813 NDA NDA022117 Organon Pharmaceuticals USA ASENAPINE MALEATE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 0052-0261_77d00374-6c42-4d3f-99d7-b7b2fd64a8fb 0052-0261 HUMAN PRESCRIPTION DRUG Desogen desogestrel and ethinyl estradiol KIT 20100610 NDA NDA020071 Organon USA Inc. N 20181231 0052-0272_28d5d9d6-a604-4b37-ac4e-42fe955988fe 0052-0272 HUMAN PRESCRIPTION DRUG IMPLANON etonogestrel IMPLANT SUBCUTANEOUS 20110906 NDA NDA021529 Organon USA Inc. ETONOGESTREL 68 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0052-0273_1047e1e2-da18-473b-896a-678080a8cddc 0052-0273 HUMAN PRESCRIPTION DRUG NuvaRing etonogestrel and ethinyl estradiol INSERT, EXTENDED RELEASE VAGINAL 20011003 NDA NDA021187 Organon USA Inc. ETONOGESTREL; ETHINYL ESTRADIOL .12; .015 mg/d; mg/d Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0052-0274_7dee8239-af76-48ba-bfbf-afd82194b69a 0052-0274 HUMAN PRESCRIPTION DRUG Nexplanon etonogestrel IMPLANT SUBCUTANEOUS 20060717 NDA NDA021529 Organon USA Inc. ETONOGESTREL 68 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0052-0301_a6451f5e-660b-4ae2-93ac-af6902720278 0052-0301 HUMAN PRESCRIPTION DRUG Ganirelix Acetate Ganirelix Acetate INJECTION, SOLUTION SUBCUTANEOUS 19990729 NDA NDA021057 Organon USA Inc. GANIRELIX ACETATE 250 ug/.5mL Decreased GnRH Secretion [PE],Gonadotropin Releasing Hormone Antagonist [EPC],Gonadotropin Releasing Hormone Receptor Antagonists [MoA] E 20171231 0052-0308_fc24862f-3cac-4a57-b1d7-155b87a54a6b 0052-0308 HUMAN PRESCRIPTION DRUG Follistim AQ follitropin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20100628 NDA NDA021273 Organon USA Inc. FOLLITROPIN 75 [iU]/.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] N 20181231 0052-0309_fc24862f-3cac-4a57-b1d7-155b87a54a6b 0052-0309 HUMAN PRESCRIPTION DRUG Follistim AQ follitropin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20100628 NDA NDA021273 Organon USA Inc. FOLLITROPIN 150 [iU]/.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] N 20181231 0052-0313_9f0a164a-b65d-4789-aa66-f913b905d2be 0052-0313 HUMAN PRESCRIPTION DRUG Follistim AQ follitropin INJECTION, SOLUTION SUBCUTANEOUS 20040324 NDA NDA021211 Organon USA Inc. FOLLITROPIN 350 [iU]/.42mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] N 20181231 0052-0315_2a5e25a5-efce-477b-840b-c05416087592 0052-0315 HUMAN PRESCRIPTION DRUG Pregnyl CHORIOGONADOTROPIN ALFA KIT 19761020 NDA NDA017692 Organon USA Inc. N 20181231 0052-0316_9f0a164a-b65d-4789-aa66-f913b905d2be 0052-0316 HUMAN PRESCRIPTION DRUG Follistim AQ follitropin INJECTION, SOLUTION SUBCUTANEOUS 20040324 NDA NDA021211 Organon USA Inc. FOLLITROPIN 650 [iU]/.78mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] N 20181231 0052-0326_9f0a164a-b65d-4789-aa66-f913b905d2be 0052-0326 HUMAN PRESCRIPTION DRUG Follistim AQ follitropin INJECTION, SOLUTION SUBCUTANEOUS 20040324 NDA NDA021211 Organon USA Inc. FOLLITROPIN 975 [iU]/1.17mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] N 20181231 0052-0450_165d8174-d588-461d-8a18-8ac0988cbbb0 0052-0450 HUMAN PRESCRIPTION DRUG Zemuron rocuronium bromide INJECTION, SOLUTION INTRAVENOUS 19940317 NDA NDA020214 Organon USA Inc. ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0052-0602_f85f1cae-2113-4e38-b972-f8a59e1bf2bd 0052-0602 HUMAN PRESCRIPTION DRUG TICE BCG BACILLUS CALMETTE-GUERIN POWDER, FOR SUSPENSION INTRAVESICAL 19900824 BLA BLA102821 Organon USA Inc. BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN 50 mg/50mL Live Attenuated Bacillus Calmette-Guerin Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],BCG Vaccine [Chemical/Ingredient],Live Attenuated Bacillus Calmette-Guerin Immunotherapy [EPC],Increased Macrophage Proliferation [PE],Increased Immunologically Active Molecule Activity [PE] N 20181231 0052-0603_ffcb1677-5fc1-4969-8ea6-8e12163527d3 0052-0603 VACCINE BCG VACCINE BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS 19890621 BLA BLA103050 Organon USA Inc. BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN 50 mg/1 Live Attenuated Bacillus Calmette-Guerin Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],BCG Vaccine [Chemical/Ingredient],Live Attenuated Bacillus Calmette-Guerin Immunotherapy [EPC],Increased Macrophage Proliferation [PE],Increased Immunologically Active Molecule Activity [PE] N 20181231 0052-2139_da55e2fe-c473-46cc-a4b4-d31c8e63d148 0052-2139 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20100621 NDA NDA022117 Organon Pharmaceuticals USA ASENAPINE MALEATE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0052-2142_da55e2fe-c473-46cc-a4b4-d31c8e63d148 0052-2142 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20100621 NDA NDA022117 Organon Pharmaceuticals USA ASENAPINE MALEATE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 0052-4330_7dee8239-af76-48ba-bfbf-afd82194b69a 0052-4330 HUMAN PRESCRIPTION DRUG Nexplanon etonogestrel IMPLANT SUBCUTANEOUS 20130927 NDA NDA021529 Organon USA Inc. ETONOGESTREL 68 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0053-6232_b23aa8bc-25bc-4dac-9512-bd14f45845cf 0053-6232 PLASMA DERIVATIVE Mononine coagulation factor IX human KIT 19920820 BLA BLA103957 CSL Behring LLC N 20181231 0053-6233_b23aa8bc-25bc-4dac-9512-bd14f45845cf 0053-6233 PLASMA DERIVATIVE Mononine coagulation factor IX human KIT 19920820 BLA BLA103957 CSL Behring LLC N 20181231 0053-6871_38da5e81-8822-4ba6-be7b-c38573fb18ea 0053-6871 HUMAN PRESCRIPTION DRUG Stimate DESMOPRESSIN ACETATE SPRAY, METERED NASAL 20110916 NDA NDA020355 CSL Behring LLC DESMOPRESSIN ACETATE 1.5 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 0053-7201_f9b9723a-1c28-4190-9463-2c5942a56c35 0053-7201 PLASMA DERIVATIVE Zemaira alpha-1-proteinase inhibitor human KIT 20030708 BLA BLA125078 CSL Behring LLC N 20181231 0053-7631_aef1f9f9-aece-492d-9c09-8099ea79c0cc 0053-7631 PLASMA DERIVATIVE Monoclate-P ANTIHEMOPHILIC FACTOR HUMAN KIT 19900530 BLA BLA103953 CSL Behring LLC E 20171231 0053-7632_aef1f9f9-aece-492d-9c09-8099ea79c0cc 0053-7632 PLASMA DERIVATIVE Monoclate-P ANTIHEMOPHILIC FACTOR HUMAN KIT 19900530 BLA BLA103953 CSL Behring LLC E 20171231 0053-7633_aef1f9f9-aece-492d-9c09-8099ea79c0cc 0053-7633 PLASMA DERIVATIVE Monoclate-P ANTIHEMOPHILIC FACTOR HUMAN KIT 19900530 BLA BLA103953 CSL Behring LLC E 20171231 0053-7634_aef1f9f9-aece-492d-9c09-8099ea79c0cc 0053-7634 PLASMA DERIVATIVE Monoclate-P ANTIHEMOPHILIC FACTOR HUMAN KIT 20040304 BLA BLA103953 CSL Behring LLC E 20171231 0053-8131_bc0801dd-a97c-4dc3-8484-4c7344923c27 0053-8131 PLASMA DERIVATIVE Helixate FS Antihemophilic Factor, Recombinant KIT 20000818 BLA BLA103332 CSL Behring LLC N 20181231 0053-8132_bc0801dd-a97c-4dc3-8484-4c7344923c27 0053-8132 PLASMA DERIVATIVE Helixate FS Antihemophilic Factor, Recombinant KIT 20000818 BLA BLA103332 CSL Behring LLC N 20181231 0053-8133_bc0801dd-a97c-4dc3-8484-4c7344923c27 0053-8133 PLASMA DERIVATIVE Helixate FS Antihemophilic Factor, Recombinant KIT 20000818 BLA BLA103332 CSL Behring LLC N 20181231 0053-8134_bc0801dd-a97c-4dc3-8484-4c7344923c27 0053-8134 PLASMA DERIVATIVE Helixate FS Antihemophilic Factor, Recombinant KIT 20080116 BLA BLA103332 CSL Behring LLC N 20181231 0053-8135_bc0801dd-a97c-4dc3-8484-4c7344923c27 0053-8135 PLASMA DERIVATIVE Helixate FS Antihemophilic Factor, Recombinant KIT 20090731 BLA BLA103332 CSL Behring LLC N 20181231 0054-0002_6448920d-bf23-4f56-8c32-5c711c3890a0 0054-0002 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20040729 ANDA ANDA076246 West-Ward Pharmaceuticals Corp. FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0054-0003_6448920d-bf23-4f56-8c32-5c711c3890a0 0054-0003 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20040729 ANDA ANDA076246 West-Ward Pharmaceuticals Corp. FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0054-0007_cc8fb866-686c-4fc5-af5a-c21c5a8e120b 0054-0007 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE ORAL 20060327 ANDA ANDA076917 West-Ward Pharmaceuticals Corp. CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 0054-0010_fb4e03f5-aaef-472e-8109-7726f6362c22 0054-0010 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20030114 ANDA ANDA076278 West-Ward Pharmaceuticals Corp. FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] N 20181231 0054-0011_fb4e03f5-aaef-472e-8109-7726f6362c22 0054-0011 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20030114 ANDA ANDA076278 West-Ward Pharmaceuticals Corp. FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 0054-0012_fb4e03f5-aaef-472e-8109-7726f6362c22 0054-0012 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20030114 ANDA ANDA076278 West-Ward Pharmaceuticals Corp. FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 0054-0017_78b4b086-d886-4e76-9ab5-d3f32a5fae32 0054-0017 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 West-Ward Pharmaceuticals Corp. PREDNISONE 10 mg/1 N 20181231 0054-0018_78b4b086-d886-4e76-9ab5-d3f32a5fae32 0054-0018 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 West-Ward Pharmaceuticals Corp. PREDNISONE 20 mg/1 N 20181231 0054-0019_78b4b086-d886-4e76-9ab5-d3f32a5fae32 0054-0019 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030314 ANDA ANDA084283 West-Ward Pharmaceuticals Corp. PREDNISONE 50 mg/1 N 20181231 0054-0020_9a7224cc-6d87-418c-b7ec-11519956a511 0054-0020 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20040105 ANDA ANDA076691 West-Ward Pharmaceuticals Corp. LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] N 20181231 0054-0021_4d7d6e8e-e8f2-48ae-9fd7-6bebc81b8681 0054-0021 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20041028 ANDA ANDA076832 West-Ward Pharmaceuticals Corp. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 0054-0025_d05df5e7-2c68-4635-b527-130daac9847d 0054-0025 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride mefloquine hydrochloride TABLET ORAL 20041001 ANDA ANDA076523 West-Ward Pharmaceuticals Corp. MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] N 20181231 0054-0028_22e44fc6-35df-4e96-96b6-31054e157a9a 0054-0028 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20050517 ANDA ANDA077024 West-Ward Pharmaceuticals Corp. CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0054-0036_f9a98ca3-9353-4b44-8144-22311f1759c6 0054-0036 HUMAN PRESCRIPTION DRUG Clarithromycin clarithromycin TABLET, COATED ORAL 20041122 20190523 ANDA ANDA065178 West-Ward Pharmaceuticals Corp. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0054-0037_f9a98ca3-9353-4b44-8144-22311f1759c6 0054-0037 HUMAN PRESCRIPTION DRUG Clarithromycin clarithromycin TABLET, COATED ORAL 20040525 20200705 ANDA ANDA065178 West-Ward Pharmaceuticals Corp. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0054-0044_22e44fc6-35df-4e96-96b6-31054e157a9a 0054-0044 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20050517 ANDA ANDA077024 West-Ward Pharmaceuticals Corp. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0054-0045_b7a01313-c7cf-4a53-b962-ad274cdb2067 0054-0045 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY NASAL 20031105 ANDA ANDA076664 West-Ward Pharmaceuticals Corp. IPRATROPIUM BROMIDE 21 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0054-0046_2dbc0c8c-2b66-4ba0-b35d-59eba0f54b13 0054-0046 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY NASAL 20031105 ANDA ANDA076598 West-Ward Pharmaceuticals Corp. IPRATROPIUM BROMIDE 42 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0054-0057_63a650b0-0a53-484a-9b48-02156b37acf8 0054-0057 HUMAN PRESCRIPTION DRUG Digoxin Digoxin SOLUTION ORAL 20040826 NDA NDA021648 West-Ward Pharmaceuticals Corp. DIGOXIN .05 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0054-0062_3fb337ff-7fca-45f2-a903-ebc1b175f034 0054-0062 HUMAN PRESCRIPTION DRUG Citalopram Citalopram SOLUTION ORAL 20040525 ANDA ANDA077043 West-Ward Pharmaceuticals Corp CITALOPRAM HYDROBROMIDE 10 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0054-0063_e3b86ca5-7b80-485f-9add-eed07a27fe59 0054-0063 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20090729 ANDA ANDA076904 West-Ward Pharmaceuticals Corp RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 0054-0064_57a40a16-45e1-41f2-b1af-42072de822cb 0054-0064 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride SOLUTION ORAL 20061226 ANDA ANDA076960 West-Ward Pharmaceuticals Corp. ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 0054-0077_9952a81e-773e-4186-a6df-c53952693dbc 0054-0077 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20050303 ANDA ANDA076943 West-Ward Pharmaceuticals Corp. TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0054-0079_c567c86c-ef6d-4c64-94d4-2bf3a8437968 0054-0079 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20071228 ANDA ANDA077806 West-Ward Pharmaceuticals Corp. BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0054-0080_11cae6b3-cae2-4fc5-91b8-240abfacabf5 0054-0080 HUMAN PRESCRIPTION DRUG Exemestane Exemestane TABLET, FILM COATED ORAL 20110401 ANDA ANDA077431 West-Ward Pharmaceuticals Corp EXEMESTANE 25 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0054-0084_912a345e-2a61-46cb-ad0d-e8bf5ad88364 0054-0084 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077237 West-Ward Pharmaceuticals Corp. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 0054-0085_912a345e-2a61-46cb-ad0d-e8bf5ad88364 0054-0085 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077237 West-Ward Pharmaceuticals Corp. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 0054-0086_84e16e83-b683-4e03-908a-2732c8b59628 0054-0086 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070427 ANDA ANDA077214 Roxane Laboratories, Inc ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0054-0087_84e16e83-b683-4e03-908a-2732c8b59628 0054-0087 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070427 ANDA ANDA077214 Roxane Laboratories, Inc ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0054-0088_69d9d03f-63b5-42be-a7d3-c25043a3db6b 0054-0088 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20080226 ANDA ANDA077728 West-Ward Pharmaceuticals Corp. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0054-0090_800cd972-0602-41ba-b0b7-5b5febdf4179 0054-0090 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET ORAL 20160601 ANDA ANDA077608 West-Ward Pharmaceuticals Corp. GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0054-0091_800cd972-0602-41ba-b0b7-5b5febdf4179 0054-0091 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET ORAL 20160601 ANDA ANDA077608 West-Ward Pharmaceuticals Corp. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0054-0092_800cd972-0602-41ba-b0b7-5b5febdf4179 0054-0092 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET ORAL 20160601 ANDA ANDA077608 West-Ward Pharmaceuticals Corp. GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0054-0097_f90ed466-6598-4c46-8fde-4ca080e4f60f 0054-0097 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071009 ANDA ANDA077795 West-Ward Pharmaceticals Corp. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0054-0098_f90ed466-6598-4c46-8fde-4ca080e4f60f 0054-0098 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071009 ANDA ANDA077795 West-Ward Pharmaceticals Corp. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0054-0099_f90ed466-6598-4c46-8fde-4ca080e4f60f 0054-0099 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071009 ANDA ANDA077795 West-Ward Pharmaceticals Corp. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0054-0100_36d167ad-c049-4917-bfc0-67c3f002ae31 0054-0100 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077262 West-Ward Pharmaceuticals Corp. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0054-0101_36d167ad-c049-4917-bfc0-67c3f002ae31 0054-0101 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077262 West-Ward Pharmaceuticals Corp. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0054-0102_36d167ad-c049-4917-bfc0-67c3f002ae31 0054-0102 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077262 West-Ward Pharmaceuticals Corp. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0054-0106_d9974739-c33c-496f-8664-b71382d0c078 0054-0106 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 West-Ward Pharmaceuticals Corp. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0054-0107_d9974739-c33c-496f-8664-b71382d0c078 0054-0107 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 West-Ward Pharmaceuticals Corp. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0054-0108_d9974739-c33c-496f-8664-b71382d0c078 0054-0108 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 West-Ward Pharmaceuticals Corp. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0054-0109_d9974739-c33c-496f-8664-b71382d0c078 0054-0109 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 West-Ward Pharmaceuticals Corp. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0054-0110_7c636f45-9432-40c5-90f6-3c5b1396efcb 0054-0110 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA090072 West-Ward Pharmaceuticals Corp. PERINDOPRIL ERBUMINE 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0054-0111_7c636f45-9432-40c5-90f6-3c5b1396efcb 0054-0111 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA090072 West-Ward Pharmaceuticals Corp. PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0054-0112_7c636f45-9432-40c5-90f6-3c5b1396efcb 0054-0112 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA090072 West-Ward Pharmaceuticals Corp. PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0054-0114_1d505a94-810e-42d2-a50b-7a207150af80 0054-0114 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET ORAL 20100524 20190130 ANDA ANDA078656 West-Ward Pharmaceuticals Corp. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0054-0115_1d505a94-810e-42d2-a50b-7a207150af80 0054-0115 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET ORAL 20100524 20190130 ANDA ANDA078656 West-Ward Pharmaceuticals Corp. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0054-0116_8bf3c84c-bb4e-4c5d-b96a-bf83933c78e3 0054-0116 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 West-Ward Pharmaceuticals Corp. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0054-0117_8bf3c84c-bb4e-4c5d-b96a-bf83933c78e3 0054-0117 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 West-Ward Pharmaceuticals Corp. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0054-0118_8bf3c84c-bb4e-4c5d-b96a-bf83933c78e3 0054-0118 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 West-Ward Pharmaceuticals Corp. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0054-0119_8bf3c84c-bb4e-4c5d-b96a-bf83933c78e3 0054-0119 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 West-Ward Pharmaceuticals Corp. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0054-0120_8bf3c84c-bb4e-4c5d-b96a-bf83933c78e3 0054-0120 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 West-Ward Pharmaceuticals Corp. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0054-0121_8bf3c84c-bb4e-4c5d-b96a-bf83933c78e3 0054-0121 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 West-Ward Pharmaceuticals Corp. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0054-0122_8bf3c84c-bb4e-4c5d-b96a-bf83933c78e3 0054-0122 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 West-Ward Pharmaceuticals Corp. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 0054-0123_55288bef-964f-473f-a5f9-8e1871d1c65d 0054-0123 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA077459 West-Ward Pharmaceuticals Corp. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0054-0124_55288bef-964f-473f-a5f9-8e1871d1c65d 0054-0124 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA077459 West-Ward Pharmaceuticals Corp. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0054-0125_55288bef-964f-473f-a5f9-8e1871d1c65d 0054-0125 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA077459 West-Ward Pharmaceuticals Corp. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0054-0126_16aec61b-5ec2-44e7-bb9d-cf16e4bcc4aa 0054-0126 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 20190705 ANDA ANDA077732 West-Ward Pharmaceuticals Corp. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0054-0127_16aec61b-5ec2-44e7-bb9d-cf16e4bcc4aa 0054-0127 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 20190705 ANDA ANDA077732 West-Ward Pharmaceuticals Corp. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0054-0137_18c33a35-9fc7-4dbe-bf78-2a87c87b6a4b 0054-0137 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide Galantamine Hydrobromide SOLUTION ORAL 20090814 ANDA ANDA078185 West-Ward Pharmaceuticals Corp. GALANTAMINE HYDROBROMIDE 4 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0054-0140_0837a298-2e3a-4c86-93f6-638ccda2639e 0054-0140 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080507 ANDA ANDA078470 West-Ward Pharmaceuticals Corp ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 0054-0141_0837a298-2e3a-4c86-93f6-638ccda2639e 0054-0141 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080507 ANDA ANDA078470 West-Ward Pharmaceuticals Corp ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 0054-0142_0837a298-2e3a-4c86-93f6-638ccda2639e 0054-0142 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080507 ANDA ANDA078470 West-Ward Pharmaceuticals Corp ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 0054-0143_ee04cf79-6c59-4574-a3e0-6843f78917c2 0054-0143 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET ORAL 20071231 ANDA ANDA077842 West-Ward Pharmaceuticals Corp. GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0054-0163_5edb046d-b91b-4fb2-bc7d-78b9c0ab7c4e 0054-0163 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20080729 ANDA ANDA065410 West-Ward Pharmaceuticals Corp MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 0054-0164_998dd35b-7010-41c1-80fa-3511388821a9 0054-0164 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 20180308 ANDA ANDA078485 West-Ward Pharmaceuticals Corp. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0054-0166_5edb046d-b91b-4fb2-bc7d-78b9c0ab7c4e 0054-0166 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET ORAL 20080729 ANDA ANDA065413 West-Ward Pharmaceuticals Corp MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 0054-0176_171ad75c-124d-4c2d-8cfa-4c8e90e0057f 0054-0176 HUMAN PRESCRIPTION DRUG Buprenorphine HCl Buprenorphine HCl TABLET SUBLINGUAL 20091008 ANDA ANDA078633 West-Ward Pharmaceuticals Corp. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 0054-0177_171ad75c-124d-4c2d-8cfa-4c8e90e0057f 0054-0177 HUMAN PRESCRIPTION DRUG Buprenorphine HCl Buprenorphine HCl TABLET SUBLINGUAL 20091008 ANDA ANDA078633 West-Ward Pharmaceuticals Corp. BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 0054-0188_5864bc76-b088-4708-8e98-06a2d1ee8e32 0054-0188 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride and naloxone hydrochloride dihydrate buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET SUBLINGUAL 20140627 ANDA ANDA203326 West-Ward Pharmaceuticals Corp BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 0054-0189_5864bc76-b088-4708-8e98-06a2d1ee8e32 0054-0189 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride and naloxone hydrochloride dihydrate buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET SUBLINGUAL 20140627 ANDA ANDA203326 West-Ward Pharmaceuticals Corp BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 0054-0196_03550ad3-14f5-4ea2-8740-3cecf8f4a9bc 0054-0196 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET ORAL 20110103 20190209 ANDA ANDA090128 West-Ward Pharmaceuticals Corp. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0054-0197_03550ad3-14f5-4ea2-8740-3cecf8f4a9bc 0054-0197 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET ORAL 20110103 20190209 ANDA ANDA090128 West-Ward Pharmaceuticals Corp. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0054-0198_03550ad3-14f5-4ea2-8740-3cecf8f4a9bc 0054-0198 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET ORAL 20110103 20190209 ANDA ANDA090128 West-Ward Pharmaceuticals Corp. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0054-0199_2307b0a8-4d56-4a6c-8154-c472e283b36f 0054-0199 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine SUSPENSION ORAL 20121003 ANDA ANDA201193 West-Ward Pharmaceuticals Corp. OXCARBAZEPINE 300 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0054-0210_5e20e02b-8764-41bf-acd3-aecd03c2dfc8 0054-0210 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET ORAL 20080916 ANDA ANDA078913 West-Ward Pharmaceuticals Corp. PROTRIPTYLINE HYDROCHLORIDE 5 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0054-0211_5e20e02b-8764-41bf-acd3-aecd03c2dfc8 0054-0211 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET ORAL 20080916 ANDA ANDA078913 West-Ward Pharmaceuticals Corp. PROTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0054-0220_4bd83b1f-1884-4c15-a1b2-3f36a90ed263 0054-0220 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 West-Ward Pharmaceuticals Corp QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0054-0221_4bd83b1f-1884-4c15-a1b2-3f36a90ed263 0054-0221 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090749 West-Ward Pharmaceuticals Corp QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0054-0222_4bd83b1f-1884-4c15-a1b2-3f36a90ed263 0054-0222 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090749 West-Ward Pharmaceuticals Corp QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0054-0223_4bd83b1f-1884-4c15-a1b2-3f36a90ed263 0054-0223 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090749 West-Ward Pharmaceuticals Corp QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 0054-0224_cac1eb83-3c78-4b43-8669-9d3c79b57cac 0054-0224 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090115 ANDA ANDA078582 Roxane Laboratories, Inc LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0054-0228_fb129d48-37b5-4aee-9fca-408b10bc5829 0054-0228 HUMAN PRESCRIPTION DRUG meloxicam meloxicam SUSPENSION ORAL 20011101 NDA AUTHORIZED GENERIC NDA021530 Roxane Laboratories, Inc. MELOXICAM 7.5 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0054-0229_4bd83b1f-1884-4c15-a1b2-3f36a90ed263 0054-0229 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090749 West-Ward Pharmaceuticals Corp QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0054-0230_4bd83b1f-1884-4c15-a1b2-3f36a90ed263 0054-0230 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090749 West-Ward Pharmaceuticals Corp QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 0054-0235_44ec0be1-1751-4477-9327-806d79841d33 0054-0235 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022207 West-Ward Pharmaceuticals Corp MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0236_44ec0be1-1751-4477-9327-806d79841d33 0054-0236 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022207 West-Ward Pharmaceuticals Corp MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0237_38709d44-c71a-4e9f-b24b-67c47a98ad3e 0054-0237 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20080317 NDA NDA022195 West-Ward Pharmaceuticals Corp. MORPHINE SULFATE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0238_38709d44-c71a-4e9f-b24b-67c47a98ad3e 0054-0238 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20080317 NDA NDA022195 West-Ward Pharmaceuticals Corp. MORPHINE SULFATE 20 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0243_65dc53d6-1d03-4b50-9ca9-5eaa7d76a0a8 0054-0243 HUMAN PRESCRIPTION DRUG Codeine sulfate codeine sulfate TABLET ORAL 20090716 NDA NDA022402 West-Ward Pharmaceuticals Corp. CODEINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0244_65dc53d6-1d03-4b50-9ca9-5eaa7d76a0a8 0054-0244 HUMAN PRESCRIPTION DRUG Codeine sulfate codeine sulfate TABLET ORAL 20090716 NDA NDA022402 West-Ward Pharmaceuticals Corp. CODEINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0245_65dc53d6-1d03-4b50-9ca9-5eaa7d76a0a8 0054-0245 HUMAN PRESCRIPTION DRUG Codeine sulfate codeine sulfate TABLET ORAL 20090716 NDA NDA022402 West-Ward Pharmaceuticals Corp. CODEINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0250_9ccce66d-b48f-43de-8869-c0b7d94b48ac 0054-0250 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121015 ANDA ANDA090201 West-Ward Pharmaceuticals Corp. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0054-0251_9ccce66d-b48f-43de-8869-c0b7d94b48ac 0054-0251 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121015 ANDA ANDA090201 West-Ward Pharmaceuticals Corp. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0054-0252_9ccce66d-b48f-43de-8869-c0b7d94b48ac 0054-0252 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121015 ANDA ANDA090201 West-Ward Pharmaceuticals Corp. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0054-0254_86062cd7-3acc-4eae-ab01-3198b5bbe2e7 0054-0254 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20121015 ANDA ANDA090351 West-Ward Pharmaceuticals Corp. IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0054-0255_86062cd7-3acc-4eae-ab01-3198b5bbe2e7 0054-0255 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20121015 ANDA ANDA090351 West-Ward Pharmaceuticals Corp. IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0054-0259_afc66bb2-fe13-4fac-89c2-0262de9718ab 0054-0259 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20120803 ANDA ANDA090655 West-Ward Pharmaceuticals Corp. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0054-0264_1804932e-066d-4a90-962d-a762c28fba05 0054-0264 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride hydromorphone hydrochloride TABLET ORAL 20090729 ANDA ANDA074597 West-Ward Pharmaceuticals Corp. HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0265_1804932e-066d-4a90-962d-a762c28fba05 0054-0265 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride hydromorphone hydrochloride TABLET ORAL 20090729 ANDA ANDA074597 West-Ward Pharmaceuticals Corp. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0269_58547598-c747-4b82-9292-e765996920b0 0054-0269 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET ORAL 20110603 20190130 ANDA ANDA090838 West-Ward Pharmaceuticals Corp. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0054-0271_e49d45c3-396a-4b87-abab-37599c750f3b 0054-0271 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20160715 ANDA ANDA200483 West-Ward Pharmaceuticals Corp. CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0054-0272_e49d45c3-396a-4b87-abab-37599c750f3b 0054-0272 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20160715 ANDA ANDA200483 West-Ward Pharmaceuticals Corp. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0054-0273_76d25b6f-70a8-4933-ac83-71dac83e5fb4 0054-0273 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100419 ANDA ANDA091099 West-Ward Pharmaceuticals Corp. IMIPRAMINE PAMOATE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0054-0274_76d25b6f-70a8-4933-ac83-71dac83e5fb4 0054-0274 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100419 ANDA ANDA091099 West-Ward Pharmaceuticals Corp. IMIPRAMINE PAMOATE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0054-0275_76d25b6f-70a8-4933-ac83-71dac83e5fb4 0054-0275 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100419 ANDA ANDA091099 West-Ward Pharmaceuticals Corp. IMIPRAMINE PAMOATE 125 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0054-0276_76d25b6f-70a8-4933-ac83-71dac83e5fb4 0054-0276 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100419 ANDA ANDA091099 West-Ward Pharmaceuticals Corp. IMIPRAMINE PAMOATE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0054-0277_16aec61b-5ec2-44e7-bb9d-cf16e4bcc4aa 0054-0277 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 20190705 ANDA ANDA077732 West-Ward Pharmaceuticals Corp. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0054-0278_b1753b29-ce1d-4559-802f-5cab967e62b3 0054-0278 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET ORAL 20100707 ANDA ANDA090381 West-Ward Pharmaceuticals Corp. NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0054-0279_b1753b29-ce1d-4559-802f-5cab967e62b3 0054-0279 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET ORAL 20100707 ANDA ANDA090381 West-Ward Pharmaceuticals Corp. NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0054-0283_658848bf-6f01-4677-bcba-42e6eb3abf79 0054-0283 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride oxymorphone hydrochloride TABLET ORAL 20100927 ANDA ANDA090964 West-Ward Pharmaceuticals Corp. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0054-0284_658848bf-6f01-4677-bcba-42e6eb3abf79 0054-0284 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride oxymorphone hydrochloride TABLET ORAL 20100927 ANDA ANDA090964 West-Ward Pharmaceuticals Corp. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0054-0288_afc66bb2-fe13-4fac-89c2-0262de9718ab 0054-0288 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA091128 West-Ward Pharmaceuticals Corp. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0054-0289_afc66bb2-fe13-4fac-89c2-0262de9718ab 0054-0289 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA091128 West-Ward Pharmaceuticals Corp. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0054-0290_542cf222-304b-4c52-bba2-4fbf303a1274 0054-0290 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 West-Ward Pharmaceuticals Corp. ESZOPICLONE 1 mg/1 CIV N 20181231 0054-0291_542cf222-304b-4c52-bba2-4fbf303a1274 0054-0291 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 West-Ward Pharmaceuticals Corp. ESZOPICLONE 2 mg/1 CIV N 20181231 0054-0292_542cf222-304b-4c52-bba2-4fbf303a1274 0054-0292 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 West-Ward Pharmaceuticals Corp. ESZOPICLONE 3 mg/1 CIV N 20181231 0054-0293_dede4983-d07f-4461-ad4b-e6dcbd440575 0054-0293 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine Hydrochloride SPRAY, METERED NASAL 20141027 ANDA ANDA091444 West-Ward Pharmaceuticals Corp. AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0054-0295_113b5615-f978-4d29-b5c8-f29f3d3f656b 0054-0295 HUMAN PRESCRIPTION DRUG Alosetron Hydrochloride alosetron hydrochloride TABLET ORAL 20130715 ANDA ANDA200652 West-Ward Pharmaceuticals Corp. ALOSETRON HYDROCHLORIDE .5 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0054-0296_113b5615-f978-4d29-b5c8-f29f3d3f656b 0054-0296 HUMAN PRESCRIPTION DRUG Alosetron Hydrochloride alosetron hydrochloride TABLET ORAL 20130715 ANDA ANDA200652 West-Ward Pharmaceuticals Corp. ALOSETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0054-0319_8b517c16-3d51-4187-bb3e-bfa258159c08 0054-0319 HUMAN PRESCRIPTION DRUG Linezolid linezolid POWDER, FOR SUSPENSION ORAL 20150603 ANDA ANDA200068 West-Ward Pharmaceuticals Corp. LINEZOLID 100 mg/5mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0054-0320_910d587e-5e7b-4a49-ae91-e802baf4bff0 0054-0320 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160324 ANDA ANDA202606 Roxane Laboratories, Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0054-0321_910d587e-5e7b-4a49-ae91-e802baf4bff0 0054-0321 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160324 ANDA ANDA202606 Roxane Laboratories, Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0054-0322_910d587e-5e7b-4a49-ae91-e802baf4bff0 0054-0322 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160324 ANDA ANDA202606 Roxane Laboratories, Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0054-0323_910d587e-5e7b-4a49-ae91-e802baf4bff0 0054-0323 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160324 ANDA ANDA202606 Roxane Laboratories, Inc. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0054-0324_910d587e-5e7b-4a49-ae91-e802baf4bff0 0054-0324 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160324 ANDA ANDA202606 Roxane Laboratories, Inc. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0054-0325_910d587e-5e7b-4a49-ae91-e802baf4bff0 0054-0325 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160324 ANDA ANDA202606 Roxane Laboratories, Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0054-0334_a7fdcc1f-d4c9-4e49-bde3-2bd21e945e1e 0054-0334 HUMAN PRESCRIPTION DRUG Cevimeline Hydrochloride Cevimeline Hydrochloride CAPSULE ORAL 20130708 ANDA ANDA091591 West-Ward Pharmaceuticals Corp. CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 0054-0338_1854a854-6c08-4cbc-8f30-d56ee1f19a4f 0054-0338 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20140218 ANDA ANDA091433 West-Ward Pharmaceuticals Corp. DOXERCALCIFEROL .5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 0054-0339_1854a854-6c08-4cbc-8f30-d56ee1f19a4f 0054-0339 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20140218 ANDA ANDA091433 West-Ward Pharmaceuticals Corp. DOXERCALCIFEROL 2.5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 0054-0347_4ee1ca79-51e7-4010-beea-b4366448eb3a 0054-0347 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET, FILM COATED ORAL 20120430 ANDA ANDA201172 West-Ward Pharmaceuticals Corp. TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0054-0348_4ee1ca79-51e7-4010-beea-b4366448eb3a 0054-0348 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET, FILM COATED ORAL 20120430 ANDA ANDA201172 West-Ward Pharmaceuticals Corp. TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0054-0349_d84530d0-f637-4268-b319-04a54dd00f72 0054-0349 HUMAN PRESCRIPTION DRUG Phenoxybenzamine Hydrochloride Phenoxybenzamine Hydrochloride CAPSULE ORAL 20150810 ANDA ANDA201050 West-Ward Pharmaceuticals Corp. PHENOXYBENZAMINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0054-0356_e81b6a85-8301-4d15-b54b-875756ed3016 0054-0356 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20141104 ANDA ANDA202652 West-Ward Pharmaceuticals Corp. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 0054-0357_e81b6a85-8301-4d15-b54b-875756ed3016 0054-0357 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20141104 ANDA ANDA202652 West-Ward Pharmaceuticals Corp. DISULFIRAM 500 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 0054-0379_5a3a3ed6-3570-4231-adca-988e2d1d9d78 0054-0379 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate SUSPENSION ORAL; RECTAL 20130617 ANDA ANDA089049 West-Ward Pharmaceuticals Corp. SODIUM POLYSTYRENE SULFONATE 15 g/60mL N 20181231 0054-0382_bd87e433-2dd2-4048-a4f3-33c1285d9d3f 0054-0382 HUMAN PRESCRIPTION DRUG Cyclophosphamide Cyclophosphamide CAPSULE ORAL 20130916 NDA NDA203856 West-Ward Pharmaceuticals Corp. CYCLOPHOSPHAMIDE 25 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 0054-0383_bd87e433-2dd2-4048-a4f3-33c1285d9d3f 0054-0383 HUMAN PRESCRIPTION DRUG Cyclophosphamide Cyclophosphamide CAPSULE ORAL 20130916 NDA NDA203856 West-Ward Pharmaceuticals Corp. CYCLOPHOSPHAMIDE 50 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 0054-0386_1804932e-066d-4a90-962d-a762c28fba05 0054-0386 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride hydromorphone hydrochloride SOLUTION ORAL 20120301 ANDA ANDA074653 West-Ward Pharmaceuticals Corp. HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0388_1854a854-6c08-4cbc-8f30-d56ee1f19a4f 0054-0388 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20140218 ANDA ANDA091433 West-Ward Pharmaceuticals Corp. DOXERCALCIFEROL 1 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 0054-0389_90c02ac6-e5e2-4c97-8c68-81e4e389a195 0054-0389 HUMAN PRESCRIPTION DRUG Methamphetamine Hydrochloride Methamphetamine Hydrochloride TABLET ORAL 20161206 ANDA ANDA203846 West-Ward Pharmaceuticals Corp. METHAMPHETAMINE HYDROCHLORIDE 5 mg/1 Amphetamine Anorectic [EPC],Amphetamines [Chemical/Ingredient],Appetite Suppression [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE] CII N 20181231 0054-0390_d747a2bd-b533-4524-be48-ee5b9b989c74 0054-0390 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride SOLUTION ORAL 20140904 ANDA ANDA204037 West-Ward Pharmaceuticals Corp. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0391_ca73b08f-9e28-4df8-98a9-5bbe2f7e4844 0054-0391 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride CONCENTRATE ORAL 19880430 ANDA ANDA089897 Roxane Laboratories, Inc METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0392_ca73b08f-9e28-4df8-98a9-5bbe2f7e4844 0054-0392 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride CONCENTRATE ORAL 19880430 ANDA ANDA040180 Roxane Laboratories, Inc METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0393_c790ba78-6d1a-4b24-8a4a-75f010c2f511 0054-0393 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20140904 ANDA ANDA203208 West-Ward Pharmaceuticals Corp. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0395_6f137001-db0e-4fcb-913a-c4c8a9a602e1 0054-0395 HUMAN PRESCRIPTION DRUG Dutasteride Dutasteride CAPSULE ORAL 20130801 ANDA ANDA202204 West-Ward Pharmaceuticals Corp. DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 0054-0400_8e986614-00c6-4bb6-92a3-27fcaf1fa084 0054-0400 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204082 West-Ward Pharmaceuticals Corp. DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0054-0401_8e986614-00c6-4bb6-92a3-27fcaf1fa084 0054-0401 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204083 West-Ward Pharmaceuticals Corp. DESVENLAFAXINE SUCCINATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0054-0404_38709d44-c71a-4e9f-b24b-67c47a98ad3e 0054-0404 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20080317 NDA NDA022195 West-Ward Pharmaceuticals Corp. MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0415_d214319c-d8e9-491f-b7f5-29674983fcc6 0054-0415 HUMAN PRESCRIPTION DRUG Ethacrynic Acid Ethacrynic Acid TABLET ORAL 20170224 ANDA ANDA207262 West-Ward Pharmaceuticals Corp. ETHACRYNIC ACID 25 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0054-0427_46491f0f-7b34-4474-be46-5898b3b5b4c2 0054-0427 HUMAN PRESCRIPTION DRUG flucytosine flucytosine CAPSULE ORAL 20171018 ANDA ANDA206550 West-Ward Pharmaceuticals Corp FLUCYTOSINE 250 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20181231 0054-0428_46491f0f-7b34-4474-be46-5898b3b5b4c2 0054-0428 HUMAN PRESCRIPTION DRUG flucytosine flucytosine CAPSULE ORAL 20171018 ANDA ANDA206550 West-Ward Pharmaceuticals Corp FLUCYTOSINE 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20181231 0054-0434_ae7585ec-1280-40fe-b888-613b8a0e6ef6 0054-0434 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET ORAL 20120215 NDA AUTHORIZED GENERIC NDA012836 Roxane Laboratories, Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 0054-0435_ae7585ec-1280-40fe-b888-613b8a0e6ef6 0054-0435 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET ORAL 20120215 NDA AUTHORIZED GENERIC NDA012836 Roxane Laboratories, Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 0054-0436_ae7585ec-1280-40fe-b888-613b8a0e6ef6 0054-0436 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET ORAL 20120215 NDA AUTHORIZED GENERIC NDA012836 Roxane Laboratories, Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 0054-0450_171812bc-7c96-4e65-92d5-ec7152de6186 0054-0450 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine SUSPENSION ORAL 20120521 NDA AUTHORIZED GENERIC NDA020933 Roxane Laboratories, Inc. NEVIRAPINE 50 mg/5mL Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0054-0459_171812bc-7c96-4e65-92d5-ec7152de6186 0054-0459 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET ORAL 20120521 NDA AUTHORIZED GENERIC NDA020636 Roxane Laboratories, Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0054-0517_38709d44-c71a-4e9f-b24b-67c47a98ad3e 0054-0517 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20080317 NDA NDA022195 West-Ward Pharmaceuticals Corp. MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0522_db08764a-b691-4275-83d0-7dfd79e4896e 0054-0522 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20130716 ANDA ANDA203208 Roxane Laboratories, Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0542_34116f1f-ce3f-4a93-9533-51249346e350 0054-0542 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20140108 NDA AUTHORIZED GENERIC NDA020850 West-Ward Pharmaceuticals Corp. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0054-0543_34116f1f-ce3f-4a93-9533-51249346e350 0054-0543 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20140108 NDA AUTHORIZED GENERIC NDA020850 West-Ward Pharmaceuticals Corp. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0054-0544_34116f1f-ce3f-4a93-9533-51249346e350 0054-0544 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20140108 NDA AUTHORIZED GENERIC NDA020850 West-Ward Pharmaceuticals Corp. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0054-0545_70117808-5771-4f01-8d64-b54a9c2fec88 0054-0545 HUMAN PRESCRIPTION DRUG telmisartan and hydrochlorothiazide telmisartan and hydrochlorothiazide TABLET ORAL 20140228 NDA AUTHORIZED GENERIC NDA021162 West-Ward Pharmaceuticals Corp. TELMISARTAN; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0054-0546_70117808-5771-4f01-8d64-b54a9c2fec88 0054-0546 HUMAN PRESCRIPTION DRUG telmisartan and hydrochlorothiazide telmisartan and hydrochlorothiazide TABLET ORAL 20140228 NDA AUTHORIZED GENERIC NDA021162 West-Ward Pharmaceuticals Corp. TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0054-0547_70117808-5771-4f01-8d64-b54a9c2fec88 0054-0547 HUMAN PRESCRIPTION DRUG telmisartan and hydrochlorothiazide telmisartan and hydrochlorothiazide TABLET ORAL 20140228 NDA AUTHORIZED GENERIC NDA021162 West-Ward Pharmaceuticals Corp. TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0054-0548_8dfe658b-e22b-44c7-9be4-822af0bcf134 0054-0548 HUMAN PRESCRIPTION DRUG Lidocaine Viscous Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19850426 20180705 ANDA ANDA088802 West-Ward Pharmaceuticals Corp. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0054-0551_1a3f3afa-04dc-4cee-990d-1fad158af7db 0054-0551 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 19910201 ANDA ANDA087003 West-Ward Pharmaceuticals Corp. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-0575_1f059a7a-8fd4-48a9-a36d-daa6dcc93c81 0054-0575 HUMAN PRESCRIPTION DRUG aspirin and dipyridamole aspirin and dipyridamole CAPSULE ORAL 20150624 NDA AUTHORIZED GENERIC NDA020884 Roxane Laboratories, Inc. ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 0054-0603_8e986614-00c6-4bb6-92a3-27fcaf1fa084 0054-0603 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170829 ANDA ANDA204082 West-Ward Pharmaceuticals Corp. DESVENLAFAXINE SUCCINATE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0054-2526_cd5efdba-33f8-4d8d-b361-fa8df0ecf651 0054-2526 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870128 NDA NDA017812 West-Ward Pharmaceuticals Corp LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] N 20181231 0054-2527_cd5efdba-33f8-4d8d-b361-fa8df0ecf651 0054-2527 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19801126 NDA NDA017812 West-Ward Pharmaceuticals Corp LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 0054-2531_cd5efdba-33f8-4d8d-b361-fa8df0ecf651 0054-2531 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870128 NDA NDA017812 West-Ward Pharmaceuticals Corp LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] N 20181231 0054-3068_ab2c4449-74a9-4414-a664-7b41a9c0ef5b 0054-3068 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam SOLUTION, CONCENTRATE ORAL 19931031 ANDA ANDA074312 West-Ward Pharmaceuticals Corp. ALPRAZOLAM 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0054-3090_79566acd-d8c3-46c6-b1fd-178b3ecffd71 0054-3090 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate SPRAY, METERED NASAL 20020312 ANDA ANDA075824 West-Ward Pharmaceuticals Corp. BUTORPHANOL TARTRATE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV N 20181231 0054-3117_b9bd7be3-94d3-4a12-b15c-c08c071b46c4 0054-3117 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate SUSPENSION ORAL 20041118 OTC MONOGRAPH FINAL part331 West-Ward Pharmaceuticals Corp. CALCIUM CARBONATE 1250 mg/5mL N 20181231 0054-3120_a8689610-7ee9-47d5-a296-d3efe7577f5a 0054-3120 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol SOLUTION ORAL 20030718 ANDA ANDA076242 West-Ward Pharmaceuticals Corp. CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0054-3176_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-3176 HUMAN PRESCRIPTION DRUG Dexamethasone Intensol Dexamethasone Intensol SOLUTION, CONCENTRATE ORAL 19830901 ANDA ANDA088252 West-Ward Pharmaceuticals Corp. DEXAMETHASONE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-3177_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-3177 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone SOLUTION ORAL 19830901 ANDA ANDA088248 West-Ward Pharmaceuticals Corp. DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-3185_4a3d22f7-c388-47fa-9fac-1305bd86fc20 0054-3185 HUMAN PRESCRIPTION DRUG Diazepam Intensol Diazepam Intensol SOLUTION, CONCENTRATE ORAL 19870403 ANDA ANDA071415 West-Ward Pharmaceuticals Corp. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0054-3188_4a3d22f7-c388-47fa-9fac-1305bd86fc20 0054-3188 HUMAN PRESCRIPTION DRUG Diazepam Diazepam SOLUTION ORAL 19870403 ANDA ANDA070928 West-Ward Pharmaceuticals Corp. DIAZEPAM 5 mg/5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0054-3194_b15041be-2a01-4ab4-9a4d-58a368c7ee1f 0054-3194 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate SOLUTION ORAL 19820503 ANDA ANDA087708 West-Ward Pharmaceuticals Corp. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/5mL; mg/5mL Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 0054-3270_c0a19c84-4a25-47cc-9bc5-92a90c482994 0054-3270 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20060222 ANDA ANDA076504 West-Ward Pharmaceuticals Corp. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-3294_4487d2d4-6447-4d60-a0d5-d4bb7ffafd92 0054-3294 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 19880712 ANDA ANDA070434 West-Ward Pharmaceuticals Corp. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0054-3298_4487d2d4-6447-4d60-a0d5-d4bb7ffafd92 0054-3298 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 19870422 ANDA ANDA070433 West-Ward Pharmaceuticals Corp. FUROSEMIDE 40 mg/5mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0054-3486_2b5687c3-7c85-45dc-b3f4-97acf0ea6026 0054-3486 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19920529 20190130 ANDA ANDA073591 West-Ward Pharmaceuticals Corp. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 0054-3500_8dfe658b-e22b-44c7-9be4-822af0bcf134 0054-3500 HUMAN PRESCRIPTION DRUG Lidocaine Viscous Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19850426 ANDA ANDA088802 West-Ward Pharmaceuticals Corp. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0054-3505_74b8b9ca-ba11-4023-8fd5-344f28450811 0054-3505 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 19850403 ANDA ANDA088803 West-Ward Pharmaceuticals Corp LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0054-3527_cd5efdba-33f8-4d8d-b361-fa8df0ecf651 0054-3527 HUMAN PRESCRIPTION DRUG Lithium Lithium SOLUTION ORAL 19801223 NDA NDA018421 West-Ward Pharmaceuticals Corp LITHIUM CITRATE 8 meq/5mL Mood Stabilizer [EPC] N 20181231 0054-3532_9ec9e730-6770-43b9-9f12-8d4a70789833 0054-3532 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam SOLUTION, CONCENTRATE ORAL 19910628 ANDA ANDA072755 West-Ward Pharmaceuticals Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0054-3542_8dde688c-0d30-4be9-83ae-9bb28bd238a5 0054-3542 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20020215 ANDA ANDA075997 West-Ward Pharmaceuticals Corp. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0054-3545_426a8427-6f23-45fb-ac9d-e23c26254007 0054-3545 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride SOLUTION ORAL 19850130 ANDA ANDA088744 West-Ward Pharmaceuticals Corp. MEPERIDINE HYDROCHLORIDE 50 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-3553_dbe8d52c-5dd9-4a54-ac93-8ce4759fd20f 0054-3553 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride CONCENTRATE ORAL 19880906 ANDA ANDA089897 West-Ward Pharmaceuticals Corp. METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-3555_7d64df13-454a-4296-9359-04d57659d6f0 0054-3555 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride SOLUTION ORAL 19810522 ANDA ANDA087393 West-Ward Pharmaceuticals Corp. METHADONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0054-3556_7d64df13-454a-4296-9359-04d57659d6f0 0054-3556 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride SOLUTION ORAL 19820830 ANDA ANDA087997 West-Ward Pharmaceuticals Corp. METHADONE HYDROCHLORIDE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0054-3566_0e87b314-dc4e-4fc4-8dfb-9fd973584b92 0054-3566 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL 20020430 ANDA ANDA075873 West-Ward Pharmaceuticals Corp. MIDAZOLAM HYDROCHLORIDE 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0054-3567_20be85d3-6239-42d4-a785-bcf098acb2cf 0054-3567 HUMAN OTC DRUG Milk of Magnesia Milk of Magnesia CONCENTRATE ORAL 20010312 OTC MONOGRAPH NOT FINAL part334 West-Ward Pharmaceuticals Corp. MAGNESIUM HYDROXIDE 2400 mg/10mL N 20181231 0054-3686_287496b8-2d45-4949-8194-d540281c2532 0054-3686 HUMAN PRESCRIPTION DRUG Roxicet Oxycodone and Acetaminophen SOLUTION ORAL 19861203 ANDA ANDA089351 West-Ward Pharmaceuticals Corp OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-3721_78b4b086-d886-4e76-9ab5-d3f32a5fae32 0054-3721 HUMAN PRESCRIPTION DRUG PredniSONE Intensol PredniSONE Intensol SOLUTION, CONCENTRATE ORAL 19850220 ANDA ANDA088810 West-Ward Pharmaceuticals Corp. PREDNISONE 5 mg/mL N 20181231 0054-3722_78b4b086-d886-4e76-9ab5-d3f32a5fae32 0054-3722 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE SOLUTION ORAL 19841108 ANDA ANDA088703 West-Ward Pharmaceuticals Corp. PREDNISONE 5 mg/mL N 20181231 0054-3727_27888d2b-acfc-4b6e-8082-62cbdd4b7f9a 0054-3727 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride SOLUTION ORAL 19870515 ANDA ANDA070979 West Ward Pharmaceuticals Corp. PROPRANOLOL HYDROCHLORIDE 20 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0054-3730_27888d2b-acfc-4b6e-8082-62cbdd4b7f9a 0054-3730 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride SOLUTION ORAL 19870515 ANDA ANDA070690 West Ward Pharmaceuticals Corp. PROPRANOLOL HYDROCHLORIDE 40 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0054-4120_6911989f-6f31-416b-b534-b783f653608b 0054-4120 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate TABLET ORAL 20041118 20190524 OTC MONOGRAPH FINAL part331 West-Ward Pharmaceuticals Corp. CALCIUM CARBONATE 1250 mg/1 N 20181231 0054-4146_06718757-d576-4bd4-afa1-5e2ad8da24f3 0054-4146 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole LOZENGE ORAL; TOPICAL 20040729 ANDA ANDA076387 West-Ward Pharmaceuticals Corp. CLOTRIMAZOLE 10 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0054-4179_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-4179 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750725 ANDA ANDA084611 West-Ward Pharmaceuticals Corp. DEXAMETHASONE .5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-4180_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-4180 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603 ANDA ANDA084613 West-Ward Pharmaceuticals Corp. DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-4181_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-4181 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19830915 ANDA ANDA088306 West-Ward Pharmaceuticals Corp. DEXAMETHASONE 1 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-4182_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-4182 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750519 ANDA ANDA084610 West-Ward Pharmaceuticals Corp. DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-4183_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-4183 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19820826 ANDA ANDA087916 West-Ward Pharmaceuticals Corp. DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-4184_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-4184 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 West-Ward Pharmaceuticals Corp. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-4186_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-4186 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19830915 ANDA ANDA088316 West-Ward Pharmaceuticals Corp. DEXAMETHASONE 6 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-4218_dd91af8c-8363-4a44-8633-deb10f33b56c 0054-4218 HUMAN PRESCRIPTION DRUG DOLOPHINE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 West-Ward Pharmaceuticals Corp. METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0054-4219_dd91af8c-8363-4a44-8633-deb10f33b56c 0054-4219 HUMAN PRESCRIPTION DRUG DOLOPHINE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 West-Ward Pharmaceuticals Corp. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0054-4297_4487d2d4-6447-4d60-a0d5-d4bb7ffafd92 0054-4297 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 West-Ward Pharmaceuticals Corp. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0054-4299_4487d2d4-6447-4d60-a0d5-d4bb7ffafd92 0054-4299 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 West-Ward Pharmaceuticals Corp. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0054-4301_4487d2d4-6447-4d60-a0d5-d4bb7ffafd92 0054-4301 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19910313 ANDA ANDA070086 West-Ward Pharmaceuticals Corp. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0054-4496_3e100612-b457-4f71-b0df-f17bf29629d7 0054-4496 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19930222 ANDA ANDA072733 West-Ward Pharmaceuticals Corp. LEUCOVORIN CALCIUM 5 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0054-4497_3e100612-b457-4f71-b0df-f17bf29629d7 0054-4497 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19930222 ANDA ANDA072734 West-Ward Pharmaceuticals Corp. LEUCOVORIN CALCIUM 10 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0054-4498_3e100612-b457-4f71-b0df-f17bf29629d7 0054-4498 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19930222 ANDA ANDA072735 West-Ward Pharmaceuticals Corp. LEUCOVORIN CALCIUM 15 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0054-4499_3e100612-b457-4f71-b0df-f17bf29629d7 0054-4499 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19930222 ANDA ANDA072736 West-Ward Pharmaceuticals Corp. LEUCOVORIN CALCIUM 25 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0054-4527_cd5efdba-33f8-4d8d-b361-fa8df0ecf651 0054-4527 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 19820129 NDA NDA018558 West-Ward Pharmaceuticals Corp LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 0054-4538_b060d9c2-ece7-4d61-a748-f0fc358a3e53 0054-4538 HUMAN PRESCRIPTION DRUG DISKETS Methadone Hydrochloride TABLET ORAL 19730314 NDA NDA017058 West-Ward Pharmaceuticals Corp. METHADONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0054-4550_42fdb481-597e-4941-a98b-964d8a0635fd 0054-4550 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium TABLET ORAL 19940801 ANDA ANDA040054 West-Ward Pharmaceuticals Corp. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 0054-4570_6ebd02af-f9aa-48ed-a0fb-d96cfa95ff3c 0054-4570 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 West-Ward Pharmaceuticals Corp. METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-4571_6ebd02af-f9aa-48ed-a0fb-d96cfa95ff3c 0054-4571 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 West-Ward Pharmaceuticals Corp. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-4581_c0d3b13c-37ad-4560-983e-ea00034e5fd3 0054-4581 HUMAN PRESCRIPTION DRUG Mercaptopurine Mercaptopurine TABLET ORAL 20040213 ANDA ANDA040528 West-Ward Pharmaceuticals Corp. MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0054-4595_426a8427-6f23-45fb-ac9d-e23c26254007 0054-4595 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19970312 ANDA ANDA040110 West-Ward Pharmaceuticals Corp. MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-4596_426a8427-6f23-45fb-ac9d-e23c26254007 0054-4596 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19970312 ANDA ANDA040110 West-Ward Pharmaceuticals Corp. MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-4603_db29bace-b56b-4120-bfc4-aa5e8100301b 0054-4603 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19950929 20200131 ANDA ANDA074458 West-Ward Pharmaceuticals Corp. MEGESTROL ACETATE 20 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0054-4604_db29bace-b56b-4120-bfc4-aa5e8100301b 0054-4604 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19950929 20200131 ANDA ANDA074458 West-Ward Pharmaceuticals Corp. MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0054-4650_287496b8-2d45-4949-8194-d540281c2532 0054-4650 HUMAN PRESCRIPTION DRUG Roxicet Oxycodone and Acetaminophen TABLET ORAL 19910201 ANDA ANDA087003 West-Ward Pharmaceuticals Corp OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-4721_53c91827-5273-4597-bd59-b88b88a98885 0054-4721 HUMAN PRESCRIPTION DRUG Propantheline Bromide Propantheline Bromide TABLET, FILM COATED ORAL 19811214 ANDA ANDA080927 West-Ward Pharmaceuticals Corp. PROPANTHELINE BROMIDE 15 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0054-4728_78b4b086-d886-4e76-9ab5-d3f32a5fae32 0054-4728 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 West-Ward Pharmaceuticals Corp. PREDNISONE 5 mg/1 N 20181231 0054-4741_78b4b086-d886-4e76-9ab5-d3f32a5fae32 0054-4741 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087800 West-Ward Pharmaceuticals Corp. PREDNISONE 1 mg/1 N 20181231 0054-4742_78b4b086-d886-4e76-9ab5-d3f32a5fae32 0054-4742 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087801 West-Ward Pharmaceuticals Corp. PREDNISONE 2.5 mg/1 N 20181231 0054-8120_6911989f-6f31-416b-b534-b783f653608b 0054-8120 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate TABLET ORAL 20041118 20190524 OTC MONOGRAPH FINAL part331 West-Ward Pharmaceuticals Corp. CALCIUM CARBONATE 1250 mg/1 N 20181231 0054-8146_06718757-d576-4bd4-afa1-5e2ad8da24f3 0054-8146 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole LOZENGE ORAL; TOPICAL 20040729 ANDA ANDA076387 West-Ward Pharmaceuticals Corp. CLOTRIMAZOLE 10 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0054-8174_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-8174 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19830915 ANDA ANDA088306 West-Ward Pharmaceuticals Corp. DEXAMETHASONE 1 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-8175_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-8175 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 West-Ward Pharmaceuticals Corp. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-8176_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-8176 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19820826 ANDA ANDA087916 West-Ward Pharmaceuticals Corp. DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-8179_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-8179 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750725 ANDA ANDA084611 West-Ward Pharmaceuticals Corp. DEXAMETHASONE .5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-8180_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-8180 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603 ANDA ANDA084613 West-Ward Pharmaceuticals Corp. DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-8181_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-8181 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750519 ANDA ANDA084610 West-Ward Pharmaceuticals Corp. DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-8183_19506293-252e-42bc-a87d-2d3d63e6ac14 0054-8183 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19830915 ANDA ANDA088316 West-Ward Pharmaceuticals Corp. DEXAMETHASONE 6 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0054-8297_4487d2d4-6447-4d60-a0d5-d4bb7ffafd92 0054-8297 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 West-Ward Pharmaceuticals Corp. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0054-8299_4487d2d4-6447-4d60-a0d5-d4bb7ffafd92 0054-8299 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 West-Ward Pharmaceuticals Corp. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0054-8301_4487d2d4-6447-4d60-a0d5-d4bb7ffafd92 0054-8301 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19910313 ANDA ANDA070086 West-Ward Pharmaceuticals Corp. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0054-8496_3e100612-b457-4f71-b0df-f17bf29629d7 0054-8496 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19930222 ANDA ANDA072733 West-Ward Pharmaceuticals Corp. LEUCOVORIN CALCIUM 5 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0054-8526_cd5efdba-33f8-4d8d-b361-fa8df0ecf651 0054-8526 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870128 NDA NDA017812 West-Ward Pharmaceuticals Corp LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] N 20181231 0054-8527_cd5efdba-33f8-4d8d-b361-fa8df0ecf651 0054-8527 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19801126 NDA NDA017812 West-Ward Pharmaceuticals Corp LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 0054-8528_cd5efdba-33f8-4d8d-b361-fa8df0ecf651 0054-8528 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 19820614 NDA NDA018558 West-Ward Pharmaceuticals Corp LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 0054-8531_cd5efdba-33f8-4d8d-b361-fa8df0ecf651 0054-8531 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870128 NDA NDA017812 West-Ward Pharmaceuticals Corp LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] N 20181231 0054-8550_42fdb481-597e-4941-a98b-964d8a0635fd 0054-8550 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium TABLET ORAL 19940801 ANDA ANDA040054 West-Ward Pharmaceuticals Corp. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 0054-8553_6ebd02af-f9aa-48ed-a0fb-d96cfa95ff3c 0054-8553 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 West-Ward Pharmaceuticals Corp. METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-8554_6ebd02af-f9aa-48ed-a0fb-d96cfa95ff3c 0054-8554 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 West-Ward Pharmaceuticals Corp. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-8595_426a8427-6f23-45fb-ac9d-e23c26254007 0054-8595 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19970312 ANDA ANDA040110 West-Ward Pharmaceuticals Corp. MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-8603_db29bace-b56b-4120-bfc4-aa5e8100301b 0054-8603 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19950929 20190131 ANDA ANDA074458 West-Ward Pharmaceuticals Corp. MEGESTROL ACETATE 20 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0054-8604_db29bace-b56b-4120-bfc4-aa5e8100301b 0054-8604 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19950929 20190131 ANDA ANDA074458 West-Ward Pharmaceuticals Corp. MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0054-8648_287496b8-2d45-4949-8194-d540281c2532 0054-8648 HUMAN PRESCRIPTION DRUG Roxicet Oxycodone and Acetaminophen SOLUTION ORAL 19910117 ANDA ANDA089351 West-Ward Pharmaceuticals Corp OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-8650_287496b8-2d45-4949-8194-d540281c2532 0054-8650 HUMAN PRESCRIPTION DRUG Roxicet Oxycodone and Acetaminophen TABLET ORAL 19870311 ANDA ANDA087003 West-Ward Pharmaceuticals Corp OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0054-8724_78b4b086-d886-4e76-9ab5-d3f32a5fae32 0054-8724 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 West-Ward Pharmaceuticals Corp. PREDNISONE 5 mg/1 N 20181231 0054-8739_78b4b086-d886-4e76-9ab5-d3f32a5fae32 0054-8739 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087800 West-Ward Pharmaceuticals Corp. PREDNISONE 1 mg/1 N 20181231 0054-8740_78b4b086-d886-4e76-9ab5-d3f32a5fae32 0054-8740 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087801 West-Ward Pharmaceuticals Corp. PREDNISONE 2.5 mg/1 N 20181231 0056-0168_07c601d8-0b05-4744-af3b-0c63c87a62ee 0056-0168 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0056-0169_07c601d8-0b05-4744-af3b-0c63c87a62ee 0056-0169 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0056-0170_07c601d8-0b05-4744-af3b-0c63c87a62ee 0056-0170 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0056-0172_07c601d8-0b05-4744-af3b-0c63c87a62ee 0056-0172 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0056-0173_07c601d8-0b05-4744-af3b-0c63c87a62ee 0056-0173 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0056-0174_07c601d8-0b05-4744-af3b-0c63c87a62ee 0056-0174 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0056-0176_07c601d8-0b05-4744-af3b-0c63c87a62ee 0056-0176 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0056-0188_07c601d8-0b05-4744-af3b-0c63c87a62ee 0056-0188 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0056-0189_07c601d8-0b05-4744-af3b-0c63c87a62ee 0056-0189 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Bristol-Myers Squibb Pharma Company WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0056-0470_435037ad-fec4-4cbb-b41a-d8791c1142b4 0056-0470 HUMAN PRESCRIPTION DRUG SUSTIVA Efavirenz CAPSULE, GELATIN COATED ORAL 19980917 NDA NDA020972 Bristol-Myers Squibb Pharma Company EFAVIRENZ 50 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 0056-0474_435037ad-fec4-4cbb-b41a-d8791c1142b4 0056-0474 HUMAN PRESCRIPTION DRUG SUSTIVA efavirenz CAPSULE, GELATIN COATED ORAL 19980917 NDA NDA020972 Bristol-Myers Squibb Pharma Company EFAVIRENZ 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 0056-0510_435037ad-fec4-4cbb-b41a-d8791c1142b4 0056-0510 HUMAN PRESCRIPTION DRUG SUSTIVA efavirenz TABLET, FILM COATED ORAL 20020102 NDA NDA021360 Bristol-Myers Squibb Pharma Company EFAVIRENZ 600 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 0064-1050_39ef369b-8e81-442a-9e31-55ee8b2585bf 0064-1050 HUMAN OTC DRUG TRISEPTIN HAND AND BODY ANTISEPTIC ALCOHOL LOTION TOPICAL 20020401 OTC MONOGRAPH NOT FINAL part333E HEALTHPOINT, LTD ALCOHOL .7 mL/mL N 20181231 0064-1080_58f2bf97-8743-5857-e053-2a91aa0a13ff 0064-1080 HUMAN OTC DRUG SURGICEPT Waterless, Surgical Handscrub and Healthcare Personnel Handwash ethyl alcohol SOLUTION TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333E HEALTHPOINT, LTD ALCOHOL .75 mL/mL N 20181231 0065-0002_44765bd3-c349-08b4-1e8f-da0840724db9 0065-0002 HUMAN PRESCRIPTION DRUG NEVANAC nepafenac SUSPENSION/ DROPS OPHTHALMIC 20050906 NDA NDA021862 Alcon Laboratories, Inc. NEPAFENAC 1 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 0065-0006_cc8b9ca4-3577-49da-a758-253576d9d2b0 0065-0006 HUMAN PRESCRIPTION DRUG MOXEZA moxifloxacin hydrochloride SOLUTION OPHTHALMIC 20110118 NDA NDA022428 Alcon Laboratories, Inc. MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0065-0023_ff45948d-35fa-4be9-9e3d-11b71309fbef 0065-0023 HUMAN PRESCRIPTION DRUG MIOSTAT carbachol SOLUTION OPHTHALMIC 19740415 NDA NDA016968 Alcon Laboratories, Inc. CARBACHOL .1 mg/mL Cholinergic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 0065-0085_36e9b32e-9bac-a065-6524-88aa49fb34ea 0065-0085 HUMAN OTC DRUG Naphcon A naphazoline hydrochloride and pheniramine maleate SOLUTION/ DROPS OPHTHALMIC 19940608 NDA NDA020226 Alcon Laboratories, Inc. NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL N 20181231 0065-0092_13c7bd2c-1e6c-49c4-b205-d203fa45ecab 0065-0092 HUMAN PRESCRIPTION DRUG FLUORESCITE fluorescein sodium INJECTION, SOLUTION OPHTHALMIC 19720915 NDA NDA021980 Alcon Laboratories, Inc. FLUORESCEIN SODIUM 100 mg/mL Diagnostic Dye [EPC],Dyes [MoA] N 20181231 0065-0096_993c4b56-c81a-43a3-bd4e-31692407738f 0065-0096 HUMAN PRESCRIPTION DRUG Flarex fluorometholone acetate SUSPENSION/ DROPS OPHTHALMIC 19920206 NDA NDA019079 Alcon Laboratories, Inc. FLUOROMETHOLONE ACETATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0065-0246_771846ed-5ab6-487c-a434-08cab5f90002 0065-0246 HUMAN PRESCRIPTION DRUG Betoptic S betaxolol hydrochloride SUSPENSION/ DROPS OPHTHALMIC 19960115 NDA NDA019845 Alcon Laboratories, Inc. BETAXOLOL HYDROCHLORIDE 2.8 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 0065-0260_884ae09a-8f53-47df-8889-1f876507ac60 0065-0260 HUMAN PRESCRIPTION DRUG Travatan Z travoprost SOLUTION/ DROPS OPHTHALMIC 20061020 NDA NDA021994 Alcon Laboratories, Inc TRAVOPROST .04 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 0065-0271_338d2612-9d3a-48f8-8522-2f673d3c0694 0065-0271 HUMAN PRESCRIPTION DRUG Patanol olopatadine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19970217 NDA NDA020688 Alcon Laboratories, Inc. OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 0065-0272_0f8de215-ef71-47a5-9577-224d75618d2a 0065-0272 HUMAN PRESCRIPTION DRUG PATADAY olopatadine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20070215 NDA NDA021545 Alcon Laboratories, Inc. OLOPATADINE HYDROCHLORIDE 2 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 0065-0275_9d54e786-2836-42d7-8d68-4a93b7aec7a8 0065-0275 HUMAN PRESCRIPTION DRUG Azopt brinzolamide SUSPENSION/ DROPS OPHTHALMIC 19980430 NDA NDA020816 Alcon Laboratories, Inc. BRINZOLAMIDE 10 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] N 20181231 0065-0303_5fb7e172-f7b9-42a0-aed2-84e63b364bd0 0065-0303 HUMAN PRESCRIPTION DRUG Isopto Atropine atropine sulfate SOLUTION OPHTHALMIC 20161201 NDA NDA208151 Alcon Laboratories, Inc. ATROPINE SULFATE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0065-0325_2ecc55ae-04e6-401c-882a-3f4fd92cb882 0065-0325 HUMAN PRESCRIPTION DRUG EMADINE EMEDASTINE DIFUMARATE SOLUTION/ DROPS OPHTHALMIC 19980215 NDA NDA020706 Alcon Laboratories, Inc. EMEDASTINE DIFUMARATE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 0065-0332_7054e435-1a66-4ba7-9554-bd4f9ada5e61 0065-0332 HUMAN PRESCRIPTION DRUG PATANASE olopatadine hydrochloride SPRAY, METERED NASAL 20080428 NDA NDA021861 Alcon Laboratories, Inc. OLOPATADINE HYDROCHLORIDE 600 ug/1 Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 0065-0345_55a81f24-079e-4104-9946-c56818c93111 0065-0345 HUMAN PRESCRIPTION DRUG ALOMIDE lodoxamide tromethamine SOLUTION/ DROPS OPHTHALMIC 19930930 NDA NDA020191 Alcon Laboratories, Inc. LODOXAMIDE TROMETHAMINE 1 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 0065-0355_c9540478-c93a-4cf3-b9cb-49c2df075afb 0065-0355 HUMAN PRESCRIPTION DRUG Mydriacyl tropicamide SOLUTION/ DROPS OPHTHALMIC 19590401 ANDA ANDA084306 Alcon Laboratories, Inc. TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0065-0359_f3aecc76-3f70-443c-8c2a-8987c6f431af 0065-0359 HUMAN PRESCRIPTION DRUG Cyclomydril cyclopentolate hydrochloride and phenylephrine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19580630 ANDA ANDA084300 Alcon Laboratories, Inc. CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10 mg/mL; mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] N 20181231 0065-0395_c0d2c1dc-65ca-4372-8d17-83dd6523ab57 0065-0395 HUMAN PRESCRIPTION DRUG Cyclogyl cyclopentolate hydrochloride SOLUTION/ DROPS OPHTHALMIC 19751015 ANDA ANDA084109 Alcon Laboratories, Inc. CYCLOPENTOLATE HYDROCHLORIDE 5 mg/mL N 20181231 0065-0396_c0d2c1dc-65ca-4372-8d17-83dd6523ab57 0065-0396 HUMAN PRESCRIPTION DRUG Cyclogyl cyclopentolate hydrochloride SOLUTION/ DROPS OPHTHALMIC 19751015 ANDA ANDA084110 Alcon Laboratories, Inc. CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL N 20181231 0065-0397_c0d2c1dc-65ca-4372-8d17-83dd6523ab57 0065-0397 HUMAN PRESCRIPTION DRUG Cyclogyl cyclopentolate hydrochloride SOLUTION/ DROPS OPHTHALMIC 19751015 ANDA ANDA084108 Alcon Laboratories, Inc. CYCLOPENTOLATE HYDROCHLORIDE 20 mg/mL N 20181231 0065-0411_66f60df2-148b-4d21-ac07-e5c8cefa40a8 0065-0411 HUMAN PRESCRIPTION DRUG Betadine povidone-iodine SOLUTION OPHTHALMIC 20000401 NDA NDA018634 Alcon Laboratories, Inc. POVIDONE-IODINE 5 mg/mL N 20181231 0065-0416_2ebb5613-d157-52f1-cd0f-5acc3909dbf0 0065-0416 HUMAN OTC DRUG Tears Naturale Free dextran 70, hypromellose 2910 SOLUTION/ DROPS OPHTHALMIC 19901101 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. HYPROMELLOSE 2910 (4000 MPA.S); DEXTRAN 70 3; 1 mg/mL; mg/mL E 20171231 0065-0418_be16d162-fbbd-2270-8193-b7fe4b9f99e3 0065-0418 HUMAN OTC DRUG GenTeal Tears (Mild) dextran 70 and hypromellose 2910 SOLUTION/ DROPS OPHTHALMIC 20160301 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) 1; 3 mg/mL; mg/mL N 20181231 0065-0419_85b16338-1abe-4ad0-ba04-2bbed879092e 0065-0419 HUMAN OTC DRUG BION TEARS Dextran, Hypromellose SOLUTION/ DROPS OPHTHALMIC 19921019 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) 1; 3 mg/mL; mg/mL N 20181231 0065-0426_331cd37b-5826-bd74-adb7-c13167c6fb81 0065-0426 HUMAN OTC DRUG TEARS Naturale FORTE Dextran 70, Glycerin, Hypromellose SOLUTION/ DROPS OPHTHALMIC 20030102 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. DEXTRAN 70; GLYCERIN; HYPROMELLOSES 1; 2; 3 mg/mL; mg/mL; mg/mL N 20181231 0065-0426_d9c93e59-0389-9152-d165-06a58a0152b1 0065-0426 HUMAN OTC DRUG GenTeal Tears (Moderate) Dextran 70, Glycerin, Hypromellose SOLUTION/ DROPS OPHTHALMIC 20160301 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. DEXTRAN 70; GLYCERIN; HYPROMELLOSES 1; 2; 3 mg/mL; mg/mL; mg/mL N 20181231 0065-0429_c178dbc4-7167-47b5-ae94-73ce37e0056b 0065-0429 HUMAN OTC DRUG Systane Lubricant polyethylene glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20030225 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 0065-0431_1bdf47b1-672b-fbc6-3272-473b6b864e21 0065-0431 HUMAN OTC DRUG Systane polyethylene glycol and propylene glycol SOLUTION/ DROPS OPHTHALMIC 20090814 OTC MONOGRAPH FINAL part349 Alcon Research Ltd POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 0065-0454_6989bb8e-cbc1-4632-a0ac-fe9e9a55d2d0 0065-0454 HUMAN OTC DRUG Systane polyethylene glycol 400 and propylene glycol GEL OPHTHALMIC 20110209 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 0065-0474_6c30cb82-820b-d01e-a03f-dc18e1ea21e5 0065-0474 HUMAN OTC DRUG Systane hypromellose GEL OPHTHALMIC 20121215 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. HYPROMELLOSE 2910 (4000 MPA.S) 3 mg/g N 20181231 0065-0481_70913813-61bc-422b-bba0-094635a3a3d5 0065-0481 HUMAN OTC DRUG Systane COMPLETE propylene glycol SOLUTION/ DROPS OPHTHALMIC 20180118 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. PROPYLENE GLYCOL .06 mg/mL N 20191231 0065-0509_a2c681ba-9612-e2ba-a49c-22c4cbdfcb64 0065-0509 HUMAN OTC DRUG Systane Nighttime mineral oil and white petrolatum OINTMENT OPHTHALMIC 20080626 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. MINERAL OIL; PETROLATUM 30; 940 mg/g; mg/g N 20181231 0065-0530_8ab7b514-d653-4552-96cd-cd01d233a98a 0065-0530 HUMAN OTC DRUG Eye Stream purified water SOLUTION OPHTHALMIC 19900930 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. WATER 986 mg/mL N 20181231 0065-0543_f24a55ad-0fb7-41f6-9182-e36d7878d654 0065-0543 HUMAN PRESCRIPTION DRUG TRIESENCE triamcinolone acetonide INJECTION, SUSPENSION OPHTHALMIC 20071115 NDA NDA022048 Alcon Laboratories, Inc. TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0065-0627_047301fe-73f6-356c-ec16-a1123037f239 0065-0627 HUMAN PRESCRIPTION DRUG Vexol rimexolone SUSPENSION/ DROPS OPHTHALMIC 19950915 NDA NDA020474 Alcon Laboratories, Inc RIMEXOLONE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0065-0631_77116e63-0165-4188-a3ec-6305754414c7 0065-0631 HUMAN PRESCRIPTION DRUG MAXITROL neomycin sulfate, polymyxin b sulfate and dexamethasone OINTMENT OPHTHALMIC 19720117 NDA NDA050065 Alcon Laboratories, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0065-0638_60a2e688-b371-4f7d-870d-904c1b830551 0065-0638 HUMAN PRESCRIPTION DRUG OMNIPRED prednisolone acetate SUSPENSION OPHTHALMIC 20071106 NDA NDA017469 Alcon Laboratories, Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0065-0643_03e3d153-6093-4ee3-bfb5-228b8550c74f 0065-0643 HUMAN PRESCRIPTION DRUG Tobrex tobramycin SOLUTION/ DROPS OPHTHALMIC 19810315 NDA NDA050541 Alcon Laboratories, Inc. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0065-0644_666ac7a4-6aea-49b9-bc9a-690797563110 0065-0644 HUMAN PRESCRIPTION DRUG TOBREX tobramycin OINTMENT OPHTHALMIC 19810628 NDA NDA050555 Alcon Laboratories, Inc. TOBRAMYCIN 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0065-0645_557a6c65-71db-4835-b810-2eb7c9db3609 0065-0645 HUMAN PRESCRIPTION DRUG NATACYN natamycin SUSPENSION/ DROPS OPHTHALMIC 19801231 NDA NDA050514 Alcon Laboratories, Inc. NATAMYCIN 50 mg/mL Polyene Antimicrobial [EPC],Polyenes [Chemical/Ingredient] N 20181231 0065-0647_e54fc340-b380-498a-a153-e56c5999a289 0065-0647 HUMAN PRESCRIPTION DRUG TobraDex tobramycin and dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19880915 NDA NDA050592 Alcon Laboratories, Inc. TOBRAMYCIN; DEXAMETHASONE 3; 1 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0065-0648_4473d51f-cf6d-4fd0-9d58-1089512d97a8 0065-0648 HUMAN PRESCRIPTION DRUG TobraDex tobramycin and dexamethasone OINTMENT OPHTHALMIC 19881015 NDA NDA050616 Alcon Laboratories, Inc. TOBRAMYCIN; DEXAMETHASONE 3; 1 mg/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0065-0652_8855a88b-1b62-454f-9c3a-d22bf96a98da 0065-0652 HUMAN PRESCRIPTION DRUG TOBRADEX ST tobramycin / dexamethasone SUSPENSION/ DROPS OPHTHALMIC 20100907 NDA NDA050818 Alcon Laboratories, Inc. TOBRAMYCIN; DEXAMETHASONE 3; .5 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0065-0654_22aabbf4-87c5-4bc5-a4e3-b1631a2feb5c 0065-0654 HUMAN PRESCRIPTION DRUG CILOXAN ciprofloxacin hydrochloride OINTMENT OPHTHALMIC 19980602 NDA NDA020369 Alcon Laboratories, Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/g Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0065-0656_dd4997e6-5832-4625-ace7-b27129eb5d29 0065-0656 HUMAN PRESCRIPTION DRUG Ciloxan ciprofloxacin hydrochloride SOLUTION/ DROPS OPHTHALMIC 19910115 NDA NDA019992 Alcon Laboratories, Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0065-0660_66d42914-8c37-4be3-a430-8e8b11fe3bdd 0065-0660 HUMAN PRESCRIPTION DRUG IOPIDINE apraclonidine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19880515 NDA NDA019779 Alcon Laboratories, Inc. APRACLONIDINE HYDROCHLORIDE 10 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0065-0665_77f2bac0-e03e-43ce-9af5-1a1d9b266b20 0065-0665 HUMAN PRESCRIPTION DRUG Iopidine apraclonidine SOLUTION OPHTHALMIC 19931001 NDA NDA020258 Alcon Laboratories, Inc. APRACLONIDINE HYDROCHLORIDE 5 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0065-0741_aeb37305-c255-411f-ad5f-6a06b73e8b03 0065-0741 HUMAN PRESCRIPTION DRUG Tetracaine Hydrochloride tetracaine hydrochloride SOLUTION OPHTHALMIC 19690328 NDA NDA208135 Alcon Laboratories, Inc. TETRACAINE HYDROCHLORIDE 5 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0065-0795_d4c7c95b-28e4-46b9-b902-5085e456231e 0065-0795 HUMAN PRESCRIPTION DRUG BSS balanced salt solution SOLUTION OPHTHALMIC 19690328 NDA NDA020742 Alcon Laboratories, Inc. SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE 6.4; .75; .48; .3; 3.9; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0065-0800_decf61ac-6014-2ed2-7431-5c3f4c775a48 0065-0800 HUMAN PRESCRIPTION DRUG BSS PLUS balanced salt solution enriched with bicarbonate, dextrose, and glutathione KIT 19820628 NDA NDA018469 Alcon Laboratories, Inc. N 20181231 0065-1431_29905c09-7d6d-2c18-ed9f-d6f596bbdf6c 0065-1431 HUMAN OTC DRUG Systane Sport polyethylene glycol 400 and propylene glycol SOLUTION/ DROPS OPHTHALMIC 20160301 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 0065-1431_6a86041b-41e3-4864-882f-b9f329dbcfcd 0065-1431 HUMAN OTC DRUG Systane Ultra Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20141001 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 0065-1432_33bacf8a-4d9e-b775-d143-120be5c94023 0065-1432 HUMAN OTC DRUG Systane ULTRA polyethylene glycol 400 and propylene glycol SOLUTION/ DROPS OPHTHALMIC 20090727 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 0065-1433_49981281-d323-431b-9e90-60f13261a477 0065-1433 HUMAN OTC DRUG Systane Balance propylene glycol EMULSION OPHTHALMIC 20100727 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. PROPYLENE GLYCOL .06 mg/mL N 20181231 0065-1500_5aa1661d-27b5-49be-8fee-273202682c96 0065-1500 HUMAN OTC DRUG Systane Sport polyethylene glycol 400 and propylene glycol SOLUTION/ DROPS OPHTHALMIC 20160301 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 0065-1501_81846eec-8dda-4e54-a2aa-792eddb27fbc 0065-1501 HUMAN OTC DRUG OPTI-FREE propylene glycol EMULSION OPHTHALMIC 20150618 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. PROPYLENE GLYCOL .06 mg/mL N 20181231 0065-1502_5d8b0a68-8732-4893-93d6-e5f4d7fd03a6 0065-1502 HUMAN OTC DRUG Systane Day and Night Value Pack Polyethylene Glycol 400, Propylene Glycol 0.3% KIT 20171024 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. N 20181231 0065-1750_6c836232-5c1d-4f4e-b74c-c337f90e0bfc 0065-1750 HUMAN PRESCRIPTION DRUG ILEVRO nepafenac SUSPENSION OPHTHALMIC 20121220 NDA NDA203491 Alcon Laboratories, Inc. NEPAFENAC 3 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0065-1795_4618b4eb-bfc6-b49a-034f-cf332b1461c4 0065-1795 HUMAN PRESCRIPTION DRUG BSS balanced salt solution SOLUTION OPHTHALMIC 19690328 NDA NDA020742 Alcon Laboratories, Inc. SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE 6.4; .75; .48; .3; 3.9; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0065-4011_bbbd245e-0d71-e0ee-71b1-6aacd0d93663 0065-4011 HUMAN OTC DRUG Zaditor ketotifen fumarate SOLUTION OPHTHALMIC 20121221 ANDA ANDA077200 Alcon Laboratories, Inc. KETOTIFEN FUMARATE .35 mg/mL N 20181231 0065-4013_77d14b96-a77f-42d2-9821-5b72f623d9bd 0065-4013 HUMAN PRESCRIPTION DRUG VIGAMOX moxifloxacin hydrochloride SOLUTION/ DROPS OPHTHALMIC 20030507 NDA NDA021598 Alcon Laboratories, Inc. MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0065-4147_1165bb7c-9341-4e03-a9f0-70c16e2a45af 0065-4147 HUMAN PRESCRIPTION DRUG SIMBRINZA brinzolamide/brimonidine tartrate SUSPENSION/ DROPS OPHTHALMIC 20130501 NDA NDA204251 Alcon Laboratories, Inc. BRINZOLAMIDE; BRIMONIDINE TARTRATE 10; 2 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0065-4273_663fac90-ed0b-4518-b922-3f9ba56e5b40 0065-4273 HUMAN PRESCRIPTION DRUG Pazeo olopatadine hydrochloride SOLUTION OPHTHALMIC 20150129 NDA NDA206276 Alcon Laboratories, Inc. OLOPATADINE HYDROCHLORIDE 7 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 0065-5040_4af41f23-10e1-46a8-ac4f-48cc0eb16d55 0065-5040 HUMAN OTC DRUG Tears Naturale II Polyquad Dextran 70, Hypromellose 2910 SOLUTION OPHTHALMIC 20171110 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. HYPROMELLOSE 2910 (4000 MPA.S); DEXTRAN 70 3; 1 mg/mL; mg/mL N 20181231 0065-5050_6aad0b70-f754-4a81-9a5f-e3d5b3fe4281 0065-5050 HUMAN OTC DRUG TEARS Naturale FORTE Dextran 70, Glycerin, Hypromellose SOLUTION/ DROPS OPHTHALMIC 20030102 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. DEXTRAN 70; GLYCERIN; HYPROMELLOSES 1; 2; 3 mg/mL; mg/mL; mg/mL N 20181231 0065-5060_edcd9477-9f9c-47b4-a2b3-879ff262e8d1 0065-5060 HUMAN OTC DRUG Tears Naturale Free dextran 70, hypromellose 2910 SOLUTION/ DROPS OPHTHALMIC 19901101 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. HYPROMELLOSE 2910 (4000 MPA.S); DEXTRAN 70 3; 1 mg/mL; mg/mL N 20181231 0065-8063_487e8fc5-8449-4ec3-a7d7-fe957036c672 0065-8063 HUMAN OTC DRUG GenTeal Tears Moderate Preservative Free dextran 70, hypromellose 2910 SOLUTION/ DROPS OPHTHALMIC 20171222 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. HYPROMELLOSE 2910 (4000 MPA.S); DEXTRAN 70 3; 1 mg/mL; mg/mL N 20181231 0065-8531_77e77588-0da5-4746-8343-8c725fd5c7b4 0065-8531 HUMAN PRESCRIPTION DRUG CIPRO HC ciprofloxacin hydrochloride and hydrocortisone SUSPENSION AURICULAR (OTIC) 19990315 NDA NDA020805 Alcon Laboratories, Inc. CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE 2; 10 mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0065-8533_999cc2d8-275f-4951-bb24-bedca1d70cc9 0065-8533 HUMAN PRESCRIPTION DRUG CIPRODEX ciprofloxacin and dexamethasone SUSPENSION/ DROPS AURICULAR (OTIC) 20030804 NDA NDA021537 Alcon Laboratories, Inc. CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE 3; 1 mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0065-9240_55ac2531-fed8-4f32-9323-5adb6b378dc8 0065-9240 HUMAN PRESCRIPTION DRUG DUREZOL DUREZOL EMULSION OPHTHALMIC 20110125 NDA NDA022212 Alcon Laboratories, Inc. DIFLUPREDNATE .5 mg/mL N 20181231 0067-0003_a290d17b-89c6-4ca1-bfe7-0bd2a61ae369 0067-0003 HUMAN OTC DRUG EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE SENNOSIDES PILL ORAL 20120101 20191130 OTC MONOGRAPH NOT FINAL part334 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SENNOSIDES 15 mg/1 N 20181231 0067-0005_2309bcee-5eb1-45a6-921d-ad788f37c67e 0067-0005 HUMAN OTC DRUG EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE SENNOSIDES TABLET, CHEWABLE ORAL 20100101 OTC MONOGRAPH NOT FINAL part334 Novartis Consumer Health, Inc. SENNOSIDES 15 mg/1 N 20181231 0067-0016_800366b2-e974-4791-9a0d-c341c80ac859 0067-0016 HUMAN OTC DRUG EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE SENNOSIDES PILL ORAL 20120101 OTC MONOGRAPH NOT FINAL part334 Novartis Consumer Health, Inc. SENNOSIDES 25 mg/1 N 20181231 0067-0113_c70b8a69-f853-4981-aff5-389aa58f7169 0067-0113 HUMAN OTC DRUG Gas-X Regular Strength Chewable Cherry Simethicone TABLET, CHEWABLE ORAL 20120101 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc. DIMETHICONE 80 mg/1 N 20181231 0067-0116_86804088-9f48-4a3b-9be3-17bad6e26a81 0067-0116 HUMAN OTC DRUG Gas-X Regular Strength Chewable Peppermint Simethicone TABLET, CHEWABLE ORAL 20120101 OTC MONOGRAPH FINAL part332 Novartis Consumer Health Inc. DIMETHICONE 80 mg/1 N 20181231 0067-0117_e47df211-81ec-46a4-af3e-ddaec7de2ed0 0067-0117 HUMAN OTC DRUG Gas-X Extra Strength Simethicone TABLET, CHEWABLE ORAL 20120101 OTC MONOGRAPH FINAL part332 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC DIMETHICONE 125 mg/1 N 20181231 0067-0129_a8312477-f0f2-408c-a6c3-ca371e379c62 0067-0129 HUMAN OTC DRUG Gas-X Extra Strength Simethicone TABLET, CHEWABLE ORAL 20120101 OTC MONOGRAPH FINAL part332 Novartis Consumer Health DIMETHICONE 125 mg/1 N 20181231 0067-0134_0f595a5f-ead5-4f7d-8973-6465fc631620 0067-0134 HUMAN OTC DRUG Gas-X Extra Strength Simethicone GEL ORAL 20170518 OTC MONOGRAPH FINAL part332 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. DIMETHICONE 125 mg/1 N 20181231 0067-0949_c2ec4973-07d6-480f-b47a-ac57b4b703f1 0067-0949 HUMAN OTC DRUG Desenex MICONAZOLE NITRATE POWDER TOPICAL 20090803 OTC MONOGRAPH FINAL part333C Novartis Consumer Health, Inc. MICONAZOLE NITRATE 2 g/100g N 20181231 0067-1190_fbfa10f7-6bcc-4904-b375-9b9c1cdfaf11 0067-1190 HUMAN OTC DRUG TAVIST ALLERGY Clemastine fumarate TABLET ORAL 20100101 NDA NDA020925 Novartis Consumer Health, Inc. CLEMASTINE FUMARATE 1.34 mg/1 N 20181231 0067-2000_626242aa-d98d-4a8f-97e0-5a2127d28f44 0067-2000 HUMAN OTC DRUG Excedrin Extra Strength Pain Reliever Acetaminophen, Aspirin (NSAID), and Caffeine TABLET, FILM COATED ORAL 20060927 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0067-2021_4b7f17c3-784c-4959-9f14-4abcba88a0b2 0067-2021 HUMAN OTC DRUG Excedrin Extra Strength Geltabs Acetaminophen, Asprin, Caffeine TABLET, COATED ORAL 20110913 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0067-2035_3e7b811e-3ac3-4d19-9aba-b69de4e71922 0067-2035 HUMAN OTC DRUG Excedrin Migraine Geltabs Acetaminophen, Asprin, Caffeine TABLET, COATED ORAL 20110913 NDA NDA020802 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20191231 0067-2037_bdd243cd-972d-4ea5-9877-7b96d528a7e2 0067-2037 HUMAN OTC DRUG EXCEDRIN MIGRAINE Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 20100215 NDA NDA020802 Novartis Consumer Health, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0067-2039_54286af0-4e04-4596-89f4-377d821a396a 0067-2039 HUMAN OTC DRUG EXCEDRIN MIGRAINE Acetaminophen, Aspirin (NSAID) and Caffeine TABLET, FILM COATED ORAL 20100215 NDA NDA020802 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20191231 0067-2056_27db3313-8091-4d57-9028-5db85e7953ca 0067-2056 HUMAN OTC DRUG Excedrin PM Triple Action Caplets Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate TABLET, COATED ORAL 20140924 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; ASPIRIN; DIPHENHYDRAMINE CITRATE 250; 250; 38 mg/1; mg/1; mg/1 N 20191231 0067-2067_158a4a7a-15ad-468a-ac82-ed6008c7a8ef 0067-2067 HUMAN OTC DRUG Mineral Ice Pain Relieving Menthol GEL TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part348 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC MENTHOL, UNSPECIFIED FORM .02 g/g N 20181231 0067-2070_abcd1360-0ded-4bf1-9df2-bdcfa8f8fdce 0067-2070 HUMAN OTC DRUG NoDoz MAXIMUM STRENGTH ALERTNESS AID Caffeine TABLET, COATED ORAL 20091231 OTC MONOGRAPH FINAL part340 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CAFFEINE 200 mg/1 N 20181231 0067-2077_717009a9-877f-47ac-971f-f44c87ef5e5a 0067-2077 HUMAN OTC DRUG COMTREX Maximum Strength Cold and Cough Non-Drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, COATED ORAL 20061208 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 15 mg/1; mg/1; mg/1 E 20171231 0067-2083_801d3659-d0e8-4c3b-ac03-4fc0b9b211dc 0067-2083 HUMAN OTC DRUG COMTREX Maximum Strength Day / Night Severe Cold and Sinus Acetaminophen, Chlorpheniramine Maleate, Phenylephrin HCl KIT 20100701 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. E 20171231 0067-2086_5e857646-9619-4d12-854a-66c41490356e 0067-2086 HUMAN OTC DRUG 4 Way Fast Acting Phenylephrine hydrochloride SPRAY NASAL 20100101 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL N 20181231 0067-2091_c91cba6b-61fc-4708-9edb-3ba086cc1038 0067-2091 HUMAN OTC DRUG Vagistat-3 Miconazole nitrate KIT 20000225 ANDA ANDA075329 Novartis Consumer Health, Inc. N 20181231 0067-3998_14072289-a79f-4556-a9e9-bf28a1ed8025 0067-3998 HUMAN OTC DRUG Lamisil AT TERBINAFINE HYDROCHLORIDE CREAM TOPICAL 20050810 NDA NDA020980 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 10 mg/g N 20181231 0067-3999_1757a9c4-e989-4f2d-bedc-0ba5137c68dc 0067-3999 HUMAN OTC DRUG Lamisil AT Jock Itch TERBINAFINE HYDROCHLORIDE CREAM TOPICAL 20061208 NDA NDA020980 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 10 mg/g N 20181231 0067-4000_e74fbb63-b66b-4f2e-ab77-f3916d73540f 0067-4000 HUMAN OTC DRUG LAMISIL AT TERBINAFINE HYDROCHLORIDE SPRAY TOPICAL 20000501 NDA NDA021124 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 1 mL/100mL N 20181231 0067-4345_99ea3737-e82b-44eb-b125-b20e43e5044d 0067-4345 HUMAN PRESCRIPTION DRUG Transderm Scop scopolamine PATCH, EXTENDED RELEASE TRANSDERMAL 20071002 NDA NDA017874 Novatris Consumer Health, Inc. SCOPOLAMINE 1 mg/3d Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0067-6011_15222328-8031-4303-b6af-0ae617aa2cff 0067-6011 HUMAN OTC DRUG Meijer NICOTINE TRANSDERMAL SYSTEM Step 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20071105 NDA NDA020076 Novartis Consumer Health NICOTINE 7 mg/1 N 20181231 0067-6012_24ca5a20-ce04-4b9b-9676-e128dd7ab020 0067-6012 HUMAN OTC DRUG Meijer NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20071105 NDA NDA020076 Novartis Consumer Health NICOTINE 21 mg/24h N 20181231 0067-6013_e6681e9d-cde2-4184-b76f-bf7b01a6f8bc 0067-6013 HUMAN OTC DRUG Meijer NICOTINE TRANSDERMAL SYSTEM Step 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20071105 NDA NDA020076 Novartis Consumer Health NICOTINE 21 mg/1 N 20181231 0067-6025_7374ae02-74d4-4250-9116-21872e9545ed 0067-6025 HUMAN OTC DRUG Perdiem Sennosides, stimulant laxative PILL ORAL 20071101 OTC MONOGRAPH NOT FINAL part334 Novartis Consumer Health SENNOSIDES 15 mg/1 N 20181231 0067-6114_36393a51-bca1-4c47-9ba0-94ceff5bd1ae 0067-6114 HUMAN OTC DRUG LAMISL AF DEFENSE Tolnaftate AEROSOL, SPRAY TOPICAL 20060201 OTC MONOGRAPH FINAL part333C Novartis Consumer Health, Inc. TOLNAFTATE 10 mg/g N 20181231 0067-6171_b666efb8-bcff-43da-8c45-1e223f8a12f0 0067-6171 HUMAN OTC DRUG Lamisil AT TERBINAFINE HYDROCHLORIDE CREAM TOPICAL 20050810 NDA NDA020980 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 10 mg/g N 20181231 0067-6239_02859315-2972-4db0-b18a-b787385a6072 0067-6239 HUMAN OTC DRUG LAMISIL AT ANTIFUNGAL TERBINAFINE GEL TOPICAL 20100101 NDA NDA021958 Novartis Consumer Health, Inc. TERBINAFINE 10 mg/g N 20181231 0067-6266_c0ad1ce5-bdb3-43cc-8d07-84f250eb289f 0067-6266 HUMAN OTC DRUG LAMISL AF DEFENSE Tolnaftate CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Novartis Consumer Health, Inc. TOLNAFTATE 10 mg/g N 20181231 0067-6274_83e25d05-2819-4012-b001-c31547ed1a21 0067-6274 HUMAN OTC DRUG Gas-X Ultra Strength AntiGas Softgels Simethicone CAPSULE, LIQUID FILLED ORAL 20070901 OTC MONOGRAPH FINAL part332 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC DIMETHICONE 180 mg/1 N 20181231 0067-6275_d00ddbd7-e3f6-4e29-8753-cdae652a4d57 0067-6275 HUMAN OTC DRUG Gas-X Extra Strength Softgels Simethicone CAPSULE, LIQUID FILLED ORAL 20110912 OTC MONOGRAPH FINAL part332 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC DIMETHICONE 125 mg/1 N 20181231 0067-6280_1ee52d89-b40e-4d8d-aed9-6b1aced5d75a 0067-6280 HUMAN OTC DRUG Maalox Advanced Maximum Strength Cherry Aluminum Hydroxide, Magnesium Hydroxide,Simethicone LIQUID ORAL 20080306 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 0067-6281_57b3a01f-e2c8-4e5f-8790-368e270cf423 0067-6281 HUMAN OTC DRUG Maalox Advanced Regular Strength Mint Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20080404 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 0067-6282_ac12f0ae-6f06-4fa4-8265-37d27db8cb5d 0067-6282 HUMAN OTC DRUG Maalox Advanced Maximum Strength Mint Aluminum Hydroxide, Magnesium Hydroxide,Simethicone LIQUID ORAL 20080306 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 0067-6286_afa84298-57dd-474d-91e4-6459e02bb264 0067-6286 HUMAN OTC DRUG Prevacid 24 HR Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091012 NDA NDA022327 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC LANSOPRAZOLE 15 mg/1 N 20181231 0067-6290_ff859c0c-083c-4b6c-bc24-59a8896a63ce 0067-6290 HUMAN OTC DRUG Maalox Advanced Maximum Strength Wild Berry Aluminum Hydroxide, Magnesium Hydroxide,Simethicone LIQUID ORAL 20080306 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 0067-6291_fc454ce5-633d-4128-85f2-8d6223f99787 0067-6291 HUMAN OTC DRUG Maalox Advanced Maximum Strength Antacid and Antigas TABLET, CHEWABLE ORAL 20061212 OTC MONOGRAPH FINAL part332 Novartis Consumer Health, Inc. DIMETHICONE 60 mg/1 N 20181231 0067-6292_8a8f2d12-a621-4334-b790-7879704aeff8 0067-6292 HUMAN OTC DRUG LAMISIL AT Continuous Spray TERBINAFINE HYDROCHLORIDE LIQUID TOPICAL 20090723 NDA NDA021124 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 1.25 mL/125mL N 20181231 0067-6293_cab1adfd-d20e-47ae-9c80-b023401b4633 0067-6293 HUMAN OTC DRUG LAMISIL AT Continuous Spray TERBINAFINE HYDROCHLORIDE LIQUID TOPICAL 20090723 NDA NDA021124 Novartis Consumer Health, Inc. TERBINAFINE HYDROCHLORIDE 1.25 mL/125mL N 20181231 0067-6417_3b234645-70a7-4a30-8754-1c51c5f48052 0067-6417 HUMAN OTC DRUG Triaminic Day - Night Club Pack DEXTROMETHORPHAN, PHENYLEPHRINE and DIPHENHYDRAMINE, PHENYLEPHRINE KIT 20121015 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. N 20181231 0067-6424_46f1c9a8-590f-47db-a060-4be0c59f55ca 0067-6424 HUMAN OTC DRUG BUFFERIN LOW DOSE BUFFERED ASPIRIN ASPIRIN TABLET ORAL 20110311 OTC MONOGRAPH FINAL part343 Novartis Consumer Health, Inc. ASPIRIN 81 mg/1 E 20171231 0067-6426_fd1f2195-1536-4f7f-bc3b-0fc58f19915c 0067-6426 HUMAN OTC DRUG THERAFLU MULTI SYMPTOM SEVERE COLD ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl POWDER, FOR SOLUTION ORAL 20140701 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 0067-7916_247d4761-db8d-4ba9-bcb3-ea8e5e8b50e7 0067-7916 HUMAN OTC DRUG Theraflu Flu and Sore Throat Acetaminophen, Pheniramine Maleate, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20050513 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 0067-7917_8ddf1a14-4a1e-47bc-a194-96f28a98413f 0067-7917 HUMAN OTC DRUG Theraflu Daytime Severe Cold and Cough ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE POWDER, FOR SOLUTION ORAL 20120924 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 0067-7918_6864cfd3-f8bb-4eb4-9550-04c8b8a0cfeb 0067-7918 HUMAN OTC DRUG THERAFLU NIGHTTIME SEVERE COLD AND COUGH ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL POWDER, FOR SOLUTION ORAL 20140701 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 0067-8100_ce681c5e-448a-44b1-895d-7f80228fb92f 0067-8100 HUMAN OTC DRUG Lamisil AT Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 0067-8103_6b5e2041-3142-421a-b54f-91a001df94c0 0067-8103 HUMAN OTC DRUG Excedrin Migraine Acetaminophen, Aspirin (NSAID) and Caffeine TABLET, FILM COATED ORAL 20121022 ANDA ANDA075794 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0067-8104_bd4704f1-952a-4e2c-8494-1df332787722 0067-8104 HUMAN OTC DRUG Excedrin Extra Strength Caplets Acetaminophen, Aspirin (NSAID), and Caffeine TABLET, FILM COATED ORAL 20130116 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0067-8105_3fb5cc00-f97d-47d7-988b-0dc377c35014 0067-8105 HUMAN OTC DRUG Triaminic Day Time Cold and Cough Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20121015 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 0067-8106_40ae8bfc-4007-4483-bb08-cf32f2e802c6 0067-8106 HUMAN OTC DRUG TRIAMINIC Night Time Cold and Cough Diphenhydramine HCl, Phenylephrine HCl SYRUP ORAL 20121015 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 0067-8114_e81b01b4-6804-47e3-aa9c-0f5874ad7bde 0067-8114 HUMAN OTC DRUG Lamisil AT for Jock Itch Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 0067-8115_c5efc7e8-1f44-4b1e-be4a-206d9284d35e 0067-8115 HUMAN OTC DRUG Triaminic cough and sore throat Acetaminophen, Dextromethorphan HBr SUSPENSION ORAL 20140723 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL N 20181231 0067-8116_d2a6ca24-e88d-4326-9901-ec96b868cf0d 0067-8116 HUMAN OTC DRUG Triaminic Multi-Symptom Fever and Cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20130930 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 0067-8117_0da4b415-6aaf-4c64-9c1c-f59e7edc4db2 0067-8117 HUMAN OTC DRUG Triaminic Cold and Allergy Brompheniramine maleate, Phenylephrine HCl SYRUP ORAL 20130920 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL N 20181231 0067-8118_c297a72a-d1af-4759-be2b-929d55dbc01d 0067-8118 HUMAN OTC DRUG Triaminic Cough and Congestion Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20140620 OTC MONOGRAPH FINAL part341 Novartis Consumer Health Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 0067-8119_150b7e3b-5073-45f9-b2bb-b4ce0f618726 0067-8119 HUMAN OTC DRUG Excedrin Tension Headache Pain Reliever Acetaminophen and Caffeine TABLET, FILM COATED ORAL 20140627 20180430 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 0067-8124_1d20bb2b-a8f3-43bd-8f0a-8997a70c6681 0067-8124 HUMAN OTC DRUG Theraflu Nighttime Multi-Symptom Severe Cold Powder Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride POWDER ORAL 20150715 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 25; 10 mg/1; mg/1; mg/1 N 20181231 0067-8125_cb4b14f2-dc48-49bf-be0f-60baab796534 0067-8125 HUMAN OTC DRUG Theraflu ExpressMax Daytime Nighttime Value Pack Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl KIT 20150715 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC N 20181231 0067-8127_b5bd4b79-44bb-4ae7-80fd-2dd9488a8e2b 0067-8127 HUMAN OTC DRUG Theraflu ExpressMax Daytime Severe Cold and Cough Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20150715 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 0067-8129_57902a06-45fa-4437-95b1-af0bc8ab7418 0067-8129 HUMAN OTC DRUG Theraflu ExpressMax Nighttime Severe Cold and Cough Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl SYRUP ORAL 20150715 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 0067-8131_53b48455-db9e-496a-aea6-275eb3583fb5 0067-8131 HUMAN OTC DRUG Theraflu ExpressMax Flu, Cough, and Sore Throat Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl SYRUP ORAL 20150715 OTC MONOGRAPH FINAL part341 Novartis Consumer Health, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 0067-8132_777d2ac7-e3cc-4513-8b6f-b90b2ff2c672 0067-8132 HUMAN OTC DRUG Theraflu ExpressMax Severe Cold and Flu Syrup Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl SYRUP ORAL 20170707 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/1; mg/1; mg/1; mg/1 N 20181231 0067-8136_a05493f5-4477-48ff-ae08-d913d51a71db 0067-8136 HUMAN OTC DRUG Theraflu ExpressMax Daytime Severe Cold and Cough acetaminophen, dextromethorphan HBr, phenylephrine HCl TABLET, FILM COATED ORAL 20160705 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0067-8137_5201084d-a412-4c4f-b101-0432e97abd9f 0067-8137 HUMAN OTC DRUG Theraflu ExpressMax Nighttime Severe Cold and Cough acetaminophen, diphenhydramine HCl, phenylephrine HCl TABLET, FILM COATED ORAL 20160705 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 0067-8138_44fca1d9-5222-47c2-ab52-c9f695eb8e9b 0067-8138 HUMAN OTC DRUG Theraflu Expressmax Daytime Severe Cold and Cough and Theraflu Expressmax Nighttime Severe Cold and Cough acetaminophen, dextromethorphan HBr, phenylephrine HCl, diphenhydramine HCl KIT 20160705 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC N 20181231 0067-8139_f3ed6b8a-b06d-4144-8113-222f3e42f874 0067-8139 HUMAN OTC DRUG Excedrin Tension Headache Acetaminophen, Caffeine TABLET, FILM COATED ORAL 20161215 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20191231 0067-8140_59a26a7f-516f-4507-8dec-f40cf6cfaffc 0067-8140 HUMAN OTC DRUG EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE SENNOSIDES TABLET, CHEWABLE ORAL 20170801 OTC MONOGRAPH NOT FINAL part334 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SENNOSIDES 15 mg/1 N 20181231 0067-8141_a290d17b-89c6-4ca1-bfe7-0bd2a61ae369 0067-8141 HUMAN OTC DRUG EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE SENNOSIDES TABLET ORAL 20170701 OTC MONOGRAPH NOT FINAL part334 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SENNOSIDES 15 mg/1 N 20181231 0067-8142_fb170340-c996-46cf-b165-84e136ba4151 0067-8142 HUMAN OTC DRUG EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE SENNOSIDES PILL ORAL 20170701 OTC MONOGRAPH NOT FINAL part334 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SENNOSIDES 25 mg/1 N 20181231 0067-8143_6b256c8f-3953-4c69-9a16-ffa0511bdbcd 0067-8143 HUMAN OTC DRUG Perdiem Sennosides, stimulant laxative TABLET ORAL 20170701 OTC MONOGRAPH NOT FINAL part334 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SENNOSIDES 15 mg/1 N 20181231 0067-8145_8e22f6bc-33ce-4bb0-99be-7947aa21f60e 0067-8145 HUMAN OTC DRUG Theraflu ExpressMax Severe Cold and Flu Caplets Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20170717 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0067-8147_978a9d27-6d41-42cb-a193-11314923d2ac 0067-8147 HUMAN OTC DRUG Excedrin PM Triple Action Caplets and Excedrin Tension Headache Acetaminophen, Aspirin (NSAID), Caffeine, and Diphenhydramine Citrate KIT 20170601 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC N 20191231 0068-0007_d4068d3c-8a8e-464e-8298-99c2c38056e2 0068-0007 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 sanofi-aventis U.S. LLC DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 0068-0011_d4068d3c-8a8e-464e-8298-99c2c38056e2 0068-0011 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 sanofi-aventis U.S. LLC DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 0068-0015_d4068d3c-8a8e-464e-8298-99c2c38056e2 0068-0015 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 sanofi-aventis U.S. LLC DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 0068-0019_d4068d3c-8a8e-464e-8298-99c2c38056e2 0068-0019 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 sanofi-aventis U.S. LLC DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 0068-0020_d4068d3c-8a8e-464e-8298-99c2c38056e2 0068-0020 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 sanofi-aventis U.S. LLC DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 0068-0021_d4068d3c-8a8e-464e-8298-99c2c38056e2 0068-0021 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 sanofi-aventis U.S. LLC DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] E 20171231 0068-0277_e5d36c00-3c13-49cf-a507-5e748cf35682 0068-0277 HUMAN PRESCRIPTION DRUG Hiprex methenamine hippurate TABLET ORAL 19760909 NDA NDA017681 Sanofi-Aventis U.S. LLC METHENAMINE HIPPURATE 1 g/1 E 20171231 0068-0508_46aceac9-f69d-411c-89a5-7b865a4b9525 0068-0508 HUMAN PRESCRIPTION DRUG Rifadin rifampin CAPSULE ORAL 19710521 NDA NDA050420 Sanofi-Aventis U.S. LLC RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 0068-0509_414a7294-4fe1-442b-bf2b-5825d83991d2 0068-0509 HUMAN PRESCRIPTION DRUG Rifamate rifampin and isoniazid CAPSULE ORAL 19750711 ANDA ANDA061884 sanofi-aventis U.S. LLC RIFAMPIN; ISONIAZID 300; 150 mg/1; mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient],Antimycobacterial [EPC] N 20181231 0068-0510_46aceac9-f69d-411c-89a5-7b865a4b9525 0068-0510 HUMAN PRESCRIPTION DRUG Rifadin rifampin CAPSULE ORAL 19810715 NDA NDA050420 Sanofi-Aventis U.S. LLC RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 0068-0597_46aceac9-f69d-411c-89a5-7b865a4b9525 0068-0597 HUMAN PRESCRIPTION DRUG Rifadin IV rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19890525 NDA NDA050627 Sanofi-Aventis U.S. LLC RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 0068-0599_045733c1-045f-4475-96df-44ba199de53c 0068-0599 HUMAN PRESCRIPTION DRUG Rifadin IV NOVAPLUS rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170201 NDA NDA050627 Sanofi-Aventis U.S. LLC RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20191231 0069-0006_259db6df-55bb-4f4b-a4fc-4670364e2bd8 0069-0006 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION INTRAVENOUS 20120203 ANDA ANDA078289 Pfizer Laboratories Div Pfizer Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] E 20171231 0069-0043_23bf3db2-7e8e-4db1-bbae-e2845d47c890 0069-0043 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110721 NDA NDA201370 Pfizer Laboratories Div Pfizer Inc HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0069-0058_23bf3db2-7e8e-4db1-bbae-e2845d47c890 0069-0058 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110721 NDA NDA201370 Pfizer Laboratories Div Pfizer Inc HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0069-0059_23bf3db2-7e8e-4db1-bbae-e2845d47c890 0069-0059 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110721 NDA NDA201370 Pfizer Laboratories Div Pfizer Inc HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0069-0062_23bf3db2-7e8e-4db1-bbae-e2845d47c890 0069-0062 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110721 NDA NDA201370 Pfizer Laboratories Div Pfizer Inc HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0069-0067_2d79aad4-1444-4d81-a7e2-f98d303cbbce 0069-0067 HUMAN PRESCRIPTION DRUG OXALIPLATIN OXALIPLATIN POWDER, FOR SOLUTION INTRAVENOUS 20120809 ANDA ANDA200979 Pfizer Laboratories Div Pfizer Inc. OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] E 20171231 0069-0075_fba979ce-f5d1-4c4a-8a2f-0f170a496ec9 0069-0075 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride Topotecan Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120829 ANDA ANDA091542 Pfizer Laboratories Div Pfizer Inc. TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] E 20171231 0069-0076_38668414-00b8-4c53-b48c-9de28ed0be5f 0069-0076 HUMAN PRESCRIPTION DRUG paclitaxel paclitaxel INJECTION INTRAVENOUS 20110930 ANDA ANDA091540 Pfizer Laboratories Div Pfizer Inc. PACLITAXEL 100 mg/16.7mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] E 20171231 0069-0078_38668414-00b8-4c53-b48c-9de28ed0be5f 0069-0078 HUMAN PRESCRIPTION DRUG paclitaxel paclitaxel INJECTION INTRAVENOUS 20110930 ANDA ANDA091540 Pfizer Laboratories Div Pfizer Inc. PACLITAXEL 300 mg/50mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] E 20171231 0069-0079_38668414-00b8-4c53-b48c-9de28ed0be5f 0069-0079 HUMAN PRESCRIPTION DRUG paclitaxel paclitaxel INJECTION INTRAVENOUS 20110930 ANDA ANDA091540 Pfizer Laboratories Div Pfizer Inc. PACLITAXEL 30 mg/5mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] E 20171231 0069-0081_64db63dd-9e65-4c4e-937f-09a8ae9dcfab 0069-0081 HUMAN PRESCRIPTION DRUG Cisplatin Cisplatin INJECTION INTRAVENOUS 20120419 ANDA ANDA091062 Pfizer Laboratories Div Pfizer Inc. CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] E 20171231 0069-0084_64db63dd-9e65-4c4e-937f-09a8ae9dcfab 0069-0084 HUMAN PRESCRIPTION DRUG Cisplatin Cisplatin INJECTION INTRAVENOUS 20120419 ANDA ANDA091062 Pfizer Laboratories Div Pfizer Inc. CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] E 20171231 0069-0086_5a1b9efb-8d26-43a1-909b-d59ca0dc382a 0069-0086 HUMAN PRESCRIPTION DRUG Cladribine Cladribine INJECTION INTRAVENOUS 20110710 ANDA ANDA200510 Pfizer Laboratories Div Pfizer Inc. CLADRIBINE 1 mg/mL Purine Antimetabolite [EPC] E 20171231 0069-0088_075a3185-cd77-4dbc-8058-8b478bd01879 0069-0088 HUMAN PRESCRIPTION DRUG Tobramycin Sulfate TOBRAMYCIN SULFATE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA065407 Pfizer Laboratories Div Pfizer Inc TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 0069-0091_075a3185-cd77-4dbc-8058-8b478bd01879 0069-0091 HUMAN PRESCRIPTION DRUG Tobramycin Sulfate TOBRAMYCIN SULFATE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA065407 Pfizer Laboratories Div Pfizer Inc TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 0069-0093_61554a82-303e-44d9-a02f-cfecedcacfb7 0069-0093 HUMAN PRESCRIPTION DRUG FLUMAZENIL FLUMAZENIL INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078595 Pfizer Laboratories Div Pfizer Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 0069-0094_d8ba5590-0ff9-4ce2-a208-dff4b098732f 0069-0094 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110511 ANDA ANDA090243 Pfizer Laboratories Div Pfizer Inc VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] E 20171231 0069-0104_3b1ff388-8f64-46b2-821c-84804ec1c72b 0069-0104 HUMAN PRESCRIPTION DRUG Doxycycline DOXYCYCLINE HYCLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120821 ANDA ANDA091406 Pfizer Laboratories Div Pfizer Inc DOXYCYCLINE HYCLATE 100 mg/10mL E 20171231 0069-0105_61554a82-303e-44d9-a02f-cfecedcacfb7 0069-0105 HUMAN PRESCRIPTION DRUG FLUMAZENIL FLUMAZENIL INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078595 Pfizer Laboratories Div Pfizer Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 0069-0106_aa3f45ad-4372-423f-9493-7060254d47cc 0069-0106 HUMAN PRESCRIPTION DRUG ELELYSO Taliglucerase alfa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120501 NDA NDA022458 Pfizer Laboratories Div Pfizer Inc TALIGLUCERASE ALFA 200 U/5mL Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC],Glucosylceramidase [Chemical/Ingredient] N 20181231 0069-0107_497716fe-8f8f-4f36-b284-8490c3701abf 0069-0107 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078520 Pfizer Laboratories Div Pfizer Inc PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 0069-0108_d8ba5590-0ff9-4ce2-a208-dff4b098732f 0069-0108 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110511 ANDA ANDA090243 Pfizer Laboratories Div Pfizer Inc VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] E 20171231 0069-0109_497716fe-8f8f-4f36-b284-8490c3701abf 0069-0109 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078520 Pfizer Laboratories Div Pfizer Inc PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 0069-0112_071ffdb5-425e-4cb9-8ebf-76ac94700405 0069-0112 HUMAN PRESCRIPTION DRUG Rifampin Rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110510 ANDA ANDA065421 Pfizer Laboratories Div Pfizer Inc RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 0069-0113_e0674bdd-1ce0-4c7b-a8ee-0983abb885f3 0069-0113 HUMAN PRESCRIPTION DRUG HALOPERIDOL HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20110510 ANDA ANDA078347 Pfizer Laboratories Div Pfizer Inc HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] E 20171231 0069-0121_39a272d6-473a-4895-92a9-a61b5637900d 0069-0121 HUMAN PRESCRIPTION DRUG Famotidine FAMOTIDINE INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078642 Pfizer Laboratories Div Pfizer Inc FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 0069-0122_e479e0a6-4dd9-442f-9ede-07d170fe2f10 0069-0122 HUMAN PRESCRIPTION DRUG Tessalon benzonatate CAPSULE ORAL 19580210 NDA NDA011210 Pfizer Laboratories Div Pfizer Inc BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 0069-0125_39a272d6-473a-4895-92a9-a61b5637900d 0069-0125 HUMAN PRESCRIPTION DRUG Famotidine FAMOTIDINE INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078641 Pfizer Laboratories Div Pfizer Inc FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 0069-0126_39a272d6-473a-4895-92a9-a61b5637900d 0069-0126 HUMAN PRESCRIPTION DRUG Famotidine FAMOTIDINE INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078641 Pfizer Laboratories Div Pfizer Inc FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 0069-0135_9ae22422-ab4b-46ac-bfc7-a854452712ed 0069-0135 HUMAN PRESCRIPTION DRUG BOSULIF Bosutinib monohydrate TABLET, FILM COATED ORAL 20120904 NDA NDA203341 Pfizer Laboratories Div Pfizer Inc BOSUTINIB MONOHYDRATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 0069-0136_9ae22422-ab4b-46ac-bfc7-a854452712ed 0069-0136 HUMAN PRESCRIPTION DRUG BOSULIF Bosutinib monohydrate TABLET, FILM COATED ORAL 20120904 NDA NDA203341 Pfizer Laboratories Div Pfizer Inc BOSUTINIB MONOHYDRATE 500 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 0069-0137_23bf3db2-7e8e-4db1-bbae-e2845d47c890 0069-0137 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20130311 NDA NDA201370 Pfizer Laboratories Div Pfizer Inc HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0069-0141_21fccf79-2ee5-4f14-b667-be38858cfb99 0069-0141 HUMAN PRESCRIPTION DRUG Rifampin RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110510 ANDA ANDA065421 Pfizer Laboratories Div Pfizer Inc RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 0069-0145_7b61175d-743f-4c79-8529-6d1590407e86 0069-0145 HUMAN PRESCRIPTION DRUG INLYTA axitinib TABLET, FILM COATED ORAL 20120127 NDA NDA202324 Pfizer Laboratories Div Pfizer Inc AXITINIB 1 mg/1 Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA] N 20181231 0069-0146_1419b93e-84c5-4d48-a4a5-9524447280d0 0069-0146 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Pfizer Laboratories Div Pfizer Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 0069-0147_1419b93e-84c5-4d48-a4a5-9524447280d0 0069-0147 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Pfizer Laboratories Div Pfizer Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 0069-0148_1419b93e-84c5-4d48-a4a5-9524447280d0 0069-0148 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Pfizer Laboratories Div Pfizer Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 0069-0149_93c825f1-995c-427f-b62e-f550beab61f2 0069-0149 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201530 Pfizer Laboratories Div Pfizer Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 0069-0151_7b61175d-743f-4c79-8529-6d1590407e86 0069-0151 HUMAN PRESCRIPTION DRUG INLYTA axitinib TABLET, FILM COATED ORAL 20120127 NDA NDA202324 Pfizer Laboratories Div Pfizer Inc AXITINIB 5 mg/1 Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA] N 20181231 0069-0152_c296d15c-df78-49e7-b55a-ff070822fdf9 0069-0152 HUMAN PRESCRIPTION DRUG Cytarabine Cytarabine INJECTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 20111214 ANDA ANDA200915 Pfizer Laboratories Div Pfizer Inc. CYTARABINE 100 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 0069-0153_50594983-22ae-41d5-b790-f2964b9d1560 0069-0153 HUMAN PRESCRIPTION DRUG Cytarabine Cytarabine INJECTION INTRAVENOUS; SUBCUTANEOUS 20111214 ANDA ANDA200916 Pfizer Laboratories Div Pfizer Inc. CYTARABINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 0069-0154_161b694a-9bd5-4ef7-8524-ec9bcd366294 0069-0154 HUMAN PRESCRIPTION DRUG Cytarabine Cytarabine INJECTION INTRAVENOUS; SUBCUTANEOUS 20111214 ANDA ANDA200914 Pfizer Laboratories Div Pfizer Inc. CYTARABINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 0069-0155_4c82b965-4389-47bf-b314-f29fbe8f5438 0069-0155 HUMAN PRESCRIPTION DRUG Cytarabine Cytarabine INJECTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 20120131 ANDA ANDA201784 Pfizer Laboratories Div Pfizer Inc. CYTARABINE 2 g/20mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 0069-0181_1419b93e-84c5-4d48-a4a5-9524447280d0 0069-0181 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Pfizer Laboratories Div Pfizer Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 0069-0186_b5e71e22-eb51-4442-94e0-cc2ffffbc87b 0069-0186 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078520 Pfizer Laboratories Div Pfizer Inc PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 0069-0187_5b69d1e2-0650-401d-b991-1331cc26032f 0069-0187 HUMAN PRESCRIPTION DRUG Ibrance palbociclib CAPSULE ORAL 20150203 NDA NDA207103 Pfizer Laboratories Div Pfizer Inc PALBOCICLIB 75 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 0069-0188_5b69d1e2-0650-401d-b991-1331cc26032f 0069-0188 HUMAN PRESCRIPTION DRUG Ibrance palbociclib CAPSULE ORAL 20150203 NDA NDA207103 Pfizer Laboratories Div Pfizer Inc PALBOCICLIB 100 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 0069-0189_5b69d1e2-0650-401d-b991-1331cc26032f 0069-0189 HUMAN PRESCRIPTION DRUG Ibrance palbociclib CAPSULE ORAL 20150203 NDA NDA207103 Pfizer Laboratories Div Pfizer Inc PALBOCICLIB 125 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 0069-0193_9ae22422-ab4b-46ac-bfc7-a854452712ed 0069-0193 HUMAN PRESCRIPTION DRUG BOSULIF Bosutinib monohydrate TABLET, FILM COATED ORAL 20171001 NDA NDA203341 Pfizer Laboratories Div Pfizer Inc BOSUTINIB MONOHYDRATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 0069-0195_35ed2da4-58fb-44ae-ae4d-13769110c855 0069-0195 HUMAN PRESCRIPTION DRUG Fragmin Dalteparin Sodium INJECTION SUBCUTANEOUS 20150401 NDA NDA020287 Pfizer Laboratories Div Pfizer Inc DALTEPARIN SODIUM 2500 [iU]/.2mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0069-0196_35ed2da4-58fb-44ae-ae4d-13769110c855 0069-0196 HUMAN PRESCRIPTION DRUG Fragmin Dalteparin Sodium INJECTION SUBCUTANEOUS 20150401 NDA NDA020287 Pfizer Laboratories Div Pfizer Inc DALTEPARIN SODIUM 5000 [iU]/.2mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0069-0201_f9732eb4-371e-4c2c-9798-8d36542ef76a 0069-0201 HUMAN PRESCRIPTION DRUG Cladribine Cladribine INJECTION INTRAVENOUS 20111007 ANDA ANDA200510 Pfizer Laboratories Div Pfizer Inc. CLADRIBINE 1 mg/mL Purine Antimetabolite [EPC] E 20171231 0069-0204_72bcae83-d22e-4b5c-b61e-40b68414e2ac 0069-0204 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Pfizer Laboratories Div Pfizer Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 0069-0206_35ed2da4-58fb-44ae-ae4d-13769110c855 0069-0206 HUMAN PRESCRIPTION DRUG Fragmin Dalteparin Sodium INJECTION SUBCUTANEOUS 20150401 NDA NDA020287 Pfizer Laboratories Div Pfizer Inc DALTEPARIN SODIUM 7500 [iU]/.3mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0069-0217_35ed2da4-58fb-44ae-ae4d-13769110c855 0069-0217 HUMAN PRESCRIPTION DRUG Fragmin Dalteparin Sodium INJECTION SUBCUTANEOUS 20150401 NDA NDA020287 Pfizer Laboratories Div Pfizer Inc DALTEPARIN SODIUM 10000 [iU]/mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0069-0220_35ed2da4-58fb-44ae-ae4d-13769110c855 0069-0220 HUMAN PRESCRIPTION DRUG Fragmin Dalteparin Sodium INJECTION SUBCUTANEOUS 20150401 NDA NDA020287 Pfizer Laboratories Div Pfizer Inc DALTEPARIN SODIUM 12500 [iU]/.5mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0069-0223_35ed2da4-58fb-44ae-ae4d-13769110c855 0069-0223 HUMAN PRESCRIPTION DRUG Fragmin Dalteparin Sodium INJECTION SUBCUTANEOUS 20150401 NDA NDA020287 Pfizer Laboratories Div Pfizer Inc DALTEPARIN SODIUM 15000 [iU]/.6mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0069-0228_35ed2da4-58fb-44ae-ae4d-13769110c855 0069-0228 HUMAN PRESCRIPTION DRUG Fragmin Dalteparin Sodium INJECTION SUBCUTANEOUS 20150401 NDA NDA020287 Pfizer Laboratories Div Pfizer Inc DALTEPARIN SODIUM 18000 [iU]/.72mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0069-0232_35ed2da4-58fb-44ae-ae4d-13769110c855 0069-0232 HUMAN PRESCRIPTION DRUG Fragmin Dalteparin Sodium INJECTION SUBCUTANEOUS 20150401 NDA NDA020287 Pfizer Laboratories Div Pfizer Inc DALTEPARIN SODIUM 25000 [iU]/mL Anti-coagulant [EPC],Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0069-0242_35289e46-594b-4809-a44a-f663358ce393 0069-0242 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081031 NDA NDA022030 Pfizer Laboratories Div Pfizer Inc FESOTERODINE FUMARATE 4 mg/1 N 20181231 0069-0244_35289e46-594b-4809-a44a-f663358ce393 0069-0244 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081031 NDA NDA022030 Pfizer Laboratories Div Pfizer Inc FESOTERODINE FUMARATE 8 mg/1 N 20181231 0069-0301_7ca5bb40-708c-4c5f-a3bb-ef57924a5bd6 0069-0301 HUMAN PRESCRIPTION DRUG Tobramycin Sulfate TOBRAMYCIN SULFATE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA065407 Pfizer Laboratories Div Pfizer Inc TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 0069-0302_7ca5bb40-708c-4c5f-a3bb-ef57924a5bd6 0069-0302 HUMAN PRESCRIPTION DRUG Tobramycin Sulfate TOBRAMYCIN SULFATE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA065407 Pfizer Laboratories Div Pfizer Inc TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 0069-0336_5189bb2a-bd79-47c3-9407-8329428d9eaf 0069-0336 HUMAN PRESCRIPTION DRUG Revatio sildenafil citrate POWDER, FOR SUSPENSION ORAL 20140602 NDA NDA203109 Pfizer Laboratories Div Pfizer Inc SILDENAFIL CITRATE 10 mg/mL Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0069-0338_5189bb2a-bd79-47c3-9407-8329428d9eaf 0069-0338 HUMAN PRESCRIPTION DRUG Revatio sildenafil citrate INJECTION, SOLUTION INTRAVENOUS 20091118 NDA NDA022473 Pfizer Laboratories Div Pfizer Inc SILDENAFIL CITRATE .8 mg/mL Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0069-0400_7405ed29-0b54-4f78-9fd6-18c03a0d255d 0069-0400 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19970130 NDA NDA050733 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0069-0468_751b8e6f-c868-4077-826a-a70983951c11 0069-0468 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Pfizer Laboratories Div Pfizer Inc VARENICLINE TARTRATE .5 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] N 20181231 0069-0469_751b8e6f-c868-4077-826a-a70983951c11 0069-0469 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Pfizer Laboratories Div Pfizer Inc VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] N 20181231 0069-0471_751b8e6f-c868-4077-826a-a70983951c11 0069-0471 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate KIT 20060510 NDA NDA021928 Pfizer Laboratories Div Pfizer Inc N 20181231 0069-0501_25a22fd2-6eca-413a-bd57-acde0b6b97b0 0069-0501 HUMAN PRESCRIPTION DRUG XELJANZ XR tofacitinib TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160307 NDA NDA208246 Pfizer Laboratories Div Pfizer Inc TOFACITINIB CITRATE 11 mg/1 Janus Kinase Inhibitor [EPC],Janus Kinase Inhibitors [MoA] N 20181231 0069-0550_0631931c-59a1-4b76-a79c-24f5d0f27493 0069-0550 HUMAN PRESCRIPTION DRUG SUTENT Sunitinib malate CAPSULE ORAL 20060126 NDA NDA021938 Pfizer Laboratories Div Pfizer Inc SUNITINIB MALATE 12.5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0069-0700_2a09af01-3983-466f-8ed8-c849af848b56 0069-0700 HUMAN PRESCRIPTION DRUG Ondansetron hydrochloride and dextrose ondansetron hydrochloride and dextrose INJECTION, SOLUTION INTRAVENOUS 20090501 ANDA ANDA078308 Pfizer Labs, Division of Pfizer Inc. ONDANSETRON HYDROCHLORIDE 32 mg/50mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 0069-0770_0631931c-59a1-4b76-a79c-24f5d0f27493 0069-0770 HUMAN PRESCRIPTION DRUG SUTENT Sunitinib malate CAPSULE ORAL 20060126 NDA NDA021938 Pfizer Laboratories Div Pfizer Inc SUNITINIB MALATE 25 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0069-0807_091ac88c-36c9-45b5-8115-934c2b0dac42 0069-0807 HUMAN PRESCRIPTION DRUG SELZENTRY Maraviroc TABLET, FILM COATED ORAL 20070806 NDA NDA022128 Pfizer Laboratories Div Pfizer Inc MARAVIROC 150 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] E 20171231 0069-0808_091ac88c-36c9-45b5-8115-934c2b0dac42 0069-0808 HUMAN PRESCRIPTION DRUG SELZENTRY Maraviroc TABLET, FILM COATED ORAL 20070806 NDA NDA022128 Pfizer Laboratories Div Pfizer Inc MARAVIROC 300 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] E 20171231 0069-0809_a3dd8b23-bce0-49d0-882d-deaab17421e7 0069-0809 HUMAN PRESCRIPTION DRUG INFLECTRA infliximab-dyyb INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20161121 BLA BLA125544 Pfizer Laboratories Div Pfizer Inc INFLIXIMAB, LICENSE HOLDER UNSPECIFIED 100 mg/10mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] N 20181231 0069-0830_0631931c-59a1-4b76-a79c-24f5d0f27493 0069-0830 HUMAN PRESCRIPTION DRUG SUTENT Sunitinib malate CAPSULE ORAL 20140712 NDA NDA021938 Pfizer Laboratories Div Pfizer Inc SUNITINIB MALATE 37.5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0069-0950_8d2f3f17-c041-41e1-8ba9-066f3b96f0ad 0069-0950 HUMAN PRESCRIPTION DRUG Vibramycin Hyclate doxycycline hyclate CAPSULE ORAL 19671205 NDA NDA050007 Pfizer Laboratories Div Pfizer Inc DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0069-0970_8d2f3f17-c041-41e1-8ba9-066f3b96f0ad 0069-0970 HUMAN PRESCRIPTION DRUG Vibramycin Monohydrate doxycycline POWDER, FOR SUSPENSION ORAL 19671206 NDA NDA050006 Pfizer Laboratories Div Pfizer Inc DOXYCYCLINE 25 mg/5mL N 20181231 0069-0971_8d2f3f17-c041-41e1-8ba9-066f3b96f0ad 0069-0971 HUMAN PRESCRIPTION DRUG Vibramycin Calcium doxycycline calcium SYRUP ORAL 19740923 NDA NDA050480 Pfizer Laboratories Div Pfizer Inc DOXYCYCLINE CALCIUM 50 mg/5mL N 20181231 0069-0980_0631931c-59a1-4b76-a79c-24f5d0f27493 0069-0980 HUMAN PRESCRIPTION DRUG SUTENT Sunitinib malate CAPSULE ORAL 20060126 NDA NDA021938 Pfizer Laboratories Div Pfizer Inc SUNITINIB MALATE 50 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0069-0983_7c478aeb-7755-43a6-9cde-5897763a18e1 0069-0983 HUMAN PRESCRIPTION DRUG Romidepsin romidepsin KIT 20100104 NDA AUTHORIZED GENERIC NDA022393 Pfizer Laboratories Div Pfizer Inc N 20181231 0069-1001_25a22fd2-6eca-413a-bd57-acde0b6b97b0 0069-1001 HUMAN PRESCRIPTION DRUG XELJANZ tofacitinib TABLET, FILM COATED ORAL 20121109 NDA NDA203214 Pfizer Laboratories Div Pfizer Inc TOFACITINIB CITRATE 5 mg/1 Janus Kinase Inhibitor [EPC],Janus Kinase Inhibitors [MoA] N 20181231 0069-1010_2d79aad4-1444-4d81-a7e2-f98d303cbbce 0069-1010 HUMAN PRESCRIPTION DRUG OXALIPLATIN OXALIPLATIN POWDER, FOR SOLUTION INTRAVENOUS 20120809 ANDA ANDA200979 Pfizer Laboratories Div Pfizer Inc. OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] E 20171231 0069-1441_b1e53357-44a4-46cf-b0b1-7027ce1a813f 0069-1441 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20130504 ANDA ANDA090648 Pfizer Laboratories Div Pfizer Inc ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 0069-1441_fb308df3-afb4-417d-9e23-334a9de862dc 0069-1441 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20130504 ANDA ANDA079224 Pfizer Laboratories Div Pfizer Inc ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 0069-1520_c7ddcf56-afad-4146-bccd-d8d30a316c98 0069-1520 HUMAN PRESCRIPTION DRUG Norvasc amlodipine besylate TABLET ORAL 19920731 NDA NDA019787 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0069-1530_c7ddcf56-afad-4146-bccd-d8d30a316c98 0069-1530 HUMAN PRESCRIPTION DRUG Norvasc amlodipine besylate TABLET ORAL 19920731 NDA NDA019787 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0069-1540_c7ddcf56-afad-4146-bccd-d8d30a316c98 0069-1540 HUMAN PRESCRIPTION DRUG Norvasc amlodipine besylate TABLET ORAL 19920731 NDA NDA019787 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0069-2150_731326cd-2361-4584-b3e3-3a5b35791a85 0069-2150 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0069-2160_731326cd-2361-4584-b3e3-3a5b35791a85 0069-2160 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 10 mg/1; mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0069-2170_731326cd-2361-4584-b3e3-3a5b35791a85 0069-2170 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0069-2180_731326cd-2361-4584-b3e3-3a5b35791a85 0069-2180 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0069-2190_731326cd-2361-4584-b3e3-3a5b35791a85 0069-2190 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0069-2250_731326cd-2361-4584-b3e3-3a5b35791a85 0069-2250 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0069-2260_731326cd-2361-4584-b3e3-3a5b35791a85 0069-2260 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0069-2270_731326cd-2361-4584-b3e3-3a5b35791a85 0069-2270 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0069-2390_9db2ddc3-8193-4efc-bd39-f532ccec47c5 0069-2390 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole INJECTION, SOLUTION INTRAVENOUS 20081120 ANDA ANDA078084 Pfizer Labs, Division of Pfizer Inc METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 0069-2587_c1f85278-2a01-4c46-99d7-376315eba022 0069-2587 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110510 ANDA ANDA065397 Pfizer Laboratories Div Pfizer Inc VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 0069-2589_c1f85278-2a01-4c46-99d7-376315eba022 0069-2589 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110510 ANDA ANDA065397 Pfizer Laboratories Div Pfizer Inc VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 0069-2599_75f989f8-2943-4841-abca-37f4e0f88026 0069-2599 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110510 ANDA ANDA091469 Pfizer Laboratories Div Pfizer Inc VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 0069-2600_8d71fb42-a120-48ea-821e-a0d353146d12 0069-2600 HUMAN PRESCRIPTION DRUG Procardia nifedipine CAPSULE ORAL 19811231 NDA NDA018482 Pfizer Laboratories Div Pfizer Inc NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 0069-2601_53d9a66f-33f1-4670-af3b-76709840ecf9 0069-2601 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110919 ANDA ANDA091554 Pfizer Laboratories Div Pfizer Inc. VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 0069-2650_0a3e20ea-15e2-4b03-b400-8e2d46804d13 0069-2650 HUMAN PRESCRIPTION DRUG Procardia XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19890906 NDA NDA019684 Pfizer Laboratories Div Pfizer Inc NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 0069-2660_0a3e20ea-15e2-4b03-b400-8e2d46804d13 0069-2660 HUMAN PRESCRIPTION DRUG Procardia XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19890906 NDA NDA019684 Pfizer Laboratories Div Pfizer Inc NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 0069-2670_0a3e20ea-15e2-4b03-b400-8e2d46804d13 0069-2670 HUMAN PRESCRIPTION DRUG Procardia XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19890906 NDA NDA019684 Pfizer Laboratories Div Pfizer Inc NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 0069-2960_731326cd-2361-4584-b3e3-3a5b35791a85 0069-2960 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0069-2970_731326cd-2361-4584-b3e3-3a5b35791a85 0069-2970 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0069-2980_731326cd-2361-4584-b3e3-3a5b35791a85 0069-2980 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA NDA021540 Pfizer Laboratories Div Pfizer Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0069-3030_68449d11-add2-4569-a971-a60faa11099e 0069-3030 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19871223 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-3031_68449d11-add2-4569-a971-a60faa11099e 0069-3031 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19871223 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-3032_68449d11-add2-4569-a971-a60faa11099e 0069-3032 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19871223 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-3033_68449d11-add2-4569-a971-a60faa11099e 0069-3033 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19871223 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-3034_68449d11-add2-4569-a971-a60faa11099e 0069-3034 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19871223 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-3051_3838ebdd-5e6c-4cee-9495-5c81430f997d 0069-3051 HUMAN PRESCRIPTION DRUG ZITHROMAX AZITHROMYCIN DIHYDRATE POWDER, FOR SUSPENSION ORAL 19940928 NDA NDA050693 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 1 g/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0069-3060_1dc78626-9eac-45eb-b408-3bc1bd658f8d 0069-3060 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate TABLET, FILM COATED ORAL 19960718 NDA NDA050711 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0069-3070_1dc78626-9eac-45eb-b408-3bc1bd658f8d 0069-3070 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate TABLET, FILM COATED ORAL 20020524 NDA NDA050784 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0069-3080_3838ebdd-5e6c-4cee-9495-5c81430f997d 0069-3080 HUMAN PRESCRIPTION DRUG ZITHROMAX AZITHROMYCIN DIHYDRATE TABLET, FILM COATED ORAL 19960612 NDA NDA050730 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0069-3110_1dc78626-9eac-45eb-b408-3bc1bd658f8d 0069-3110 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate POWDER, FOR SUSPENSION ORAL 19951019 NDA NDA050710 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0069-3120_1dc78626-9eac-45eb-b408-3bc1bd658f8d 0069-3120 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate POWDER, FOR SUSPENSION ORAL 19951019 NDA NDA050710 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0069-3130_1dc78626-9eac-45eb-b408-3bc1bd658f8d 0069-3130 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate POWDER, FOR SUSPENSION ORAL 19951019 NDA NDA050710 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0069-3140_1dc78626-9eac-45eb-b408-3bc1bd658f8d 0069-3140 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate POWDER, FOR SUSPENSION ORAL 19951019 NDA NDA050710 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0069-3150_e06b256a-3b3a-4148-90cd-27e7a7a631fc 0069-3150 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19970130 NDA NDA050733 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0069-3220_96237226-b042-43d5-a25c-50061d070e75 0069-3220 HUMAN PRESCRIPTION DRUG Feldene piroxicam CAPSULE ORAL 19940525 NDA NDA018147 Pfizer Laboratories Div Pfizer Inc PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0069-3230_96237226-b042-43d5-a25c-50061d070e75 0069-3230 HUMAN PRESCRIPTION DRUG Feldene piroxicam CAPSULE ORAL 19940525 NDA NDA018147 Pfizer Laboratories Div Pfizer Inc PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0069-3241_e916bb8c-38ef-4f8c-ac32-254013339e33 0069-3241 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090911 ANDA ANDA078062 Pfizer Labs, Division of Pfizer Inc CIPROFLOXACIN 10 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 0069-3342_e916bb8c-38ef-4f8c-ac32-254013339e33 0069-3342 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090911 ANDA ANDA078062 Pfizer Labs, Division of Pfizer Inc CIPROFLOXACIN 10 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 0069-3857_4c567dd8-534e-49e4-9bc3-dea0aeaca2fe 0069-3857 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA200145 Pfizer Laboratories Div Pfizer Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 0069-3858_4c567dd8-534e-49e4-9bc3-dea0aeaca2fe 0069-3858 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA200145 Pfizer Laboratories Div Pfizer Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 0069-3859_4c567dd8-534e-49e4-9bc3-dea0aeaca2fe 0069-3859 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA200145 Pfizer Laboratories Div Pfizer Inc. GEMCITABINE HYDROCHLORIDE 2 g/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 0069-4004_e4eb69a4-25c7-4073-9b56-d4919f4c7d72 0069-4004 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130317 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-4015_e4eb69a4-25c7-4073-9b56-d4919f4c7d72 0069-4015 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140317 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-4026_e4eb69a4-25c7-4073-9b56-d4919f4c7d72 0069-4026 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140317 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-4030_34e3e4bb-2636-4045-a6e6-1bc22bc9af9a 0069-4030 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130305 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-4031_34e3e4bb-2636-4045-a6e6-1bc22bc9af9a 0069-4031 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130305 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-4032_34e3e4bb-2636-4045-a6e6-1bc22bc9af9a 0069-4032 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130305 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-4033_34e3e4bb-2636-4045-a6e6-1bc22bc9af9a 0069-4033 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130305 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-4034_34e3e4bb-2636-4045-a6e6-1bc22bc9af9a 0069-4034 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130305 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-4037_e4eb69a4-25c7-4073-9b56-d4919f4c7d72 0069-4037 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140317 NDA NDA050629 Pfizer Laboratories Div Pfizer Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0069-4170_4f1c85cd-1e0e-4ca8-8590-fb4ce83e9b53 0069-4170 HUMAN PRESCRIPTION DRUG ZMAX azithromycin dihydrate POWDER, FOR SUSPENSION ORAL 19950610 NDA NDA050797 Pfizer Laboratories Div Pfizer Inc AZITHROMYCIN DIHYDRATE 2 g/60mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0069-4190_5189bb2a-bd79-47c3-9407-8329428d9eaf 0069-4190 HUMAN PRESCRIPTION DRUG Revatio sildenafil citrate TABLET, FILM COATED ORAL 20050603 NDA NDA021845 Pfizer Laboratories Div Pfizer Inc SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0069-4200_64f8040f-938d-4236-8e22-c838c9b5f8da 0069-4200 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Pfizer Laboratories Div Pfizer Inc SILDENAFIL CITRATE 25 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0069-4210_64f8040f-938d-4236-8e22-c838c9b5f8da 0069-4210 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Pfizer Laboratories Div Pfizer Inc SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0069-4220_64f8040f-938d-4236-8e22-c838c9b5f8da 0069-4220 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Pfizer Laboratories Div Pfizer Inc SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0069-4310_e011bf03-a807-4b05-ac08-0db8b7194099 0069-4310 HUMAN PRESCRIPTION DRUG Minipress prazosin hydrochloride CAPSULE ORAL 19940510 NDA NDA017442 Pfizer Laboratories Div Pfizer Inc PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0069-4370_e011bf03-a807-4b05-ac08-0db8b7194099 0069-4370 HUMAN PRESCRIPTION DRUG Minipress prazosin hydrochloride CAPSULE ORAL 19940510 NDA NDA017442 Pfizer Laboratories Div Pfizer Inc PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0069-4380_e011bf03-a807-4b05-ac08-0db8b7194099 0069-4380 HUMAN PRESCRIPTION DRUG Minipress prazosin hydrochloride CAPSULE ORAL 19940510 NDA NDA017442 Pfizer Laboratories Div Pfizer Inc PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0069-4395_e916bb8c-38ef-4f8c-ac32-254013339e33 0069-4395 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20090911 ANDA ANDA078024 Pfizer Labs, Division of Pfizer Inc CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 0069-4396_e916bb8c-38ef-4f8c-ac32-254013339e33 0069-4396 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20090911 ANDA ANDA078024 Pfizer Labs, Division of Pfizer Inc CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 0069-4495_4bb31494-d895-4d80-a72a-c80aff94f402 0069-4495 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION, SOLUTION INTRAVENOUS 20121127 ANDA ANDA201689 Pfizer Laboratories Div Pfizer Inc. IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 0069-4496_4bb31494-d895-4d80-a72a-c80aff94f402 0069-4496 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION, SOLUTION INTRAVENOUS 20121127 ANDA ANDA201689 Pfizer Laboratories Div Pfizer Inc. IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 0069-4541_b66c70ec-f7b6-48d7-b7da-9268a368dd5d 0069-4541 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110511 ANDA ANDA040802 Pfizer Laboratories Div Pfizer Inc DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0069-4543_b66c70ec-f7b6-48d7-b7da-9268a368dd5d 0069-4543 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Pfizer Laboratories Div Pfizer Inc DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0069-4545_b66c70ec-f7b6-48d7-b7da-9268a368dd5d 0069-4545 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Pfizer Laboratories Div Pfizer Inc DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0069-4547_b66c70ec-f7b6-48d7-b7da-9268a368dd5d 0069-4547 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Pfizer Laboratories Div Pfizer Inc DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0069-5410_a3458f11-4cb4-4203-8ff1-f159523585e6 0069-5410 HUMAN PRESCRIPTION DRUG Vistaril hydroxyzine pamoate CAPSULE ORAL 19941128 NDA NDA011459 Pfizer Laboratories Div Pfizer Inc HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0069-5420_a3458f11-4cb4-4203-8ff1-f159523585e6 0069-5420 HUMAN PRESCRIPTION DRUG Vistaril hydroxyzine pamoate CAPSULE ORAL 19681115 NDA NDA011459 Pfizer Laboratories Div Pfizer Inc HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0069-5471_f18d6ad4-27d1-4cf8-a278-44f18afd600f 0069-5471 HUMAN PRESCRIPTION DRUG CEREBYX Fosphenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131028 NDA NDA020450 Pfizer Laboratories Div Pfizer Inc FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0069-5474_f18d6ad4-27d1-4cf8-a278-44f18afd600f 0069-5474 HUMAN PRESCRIPTION DRUG CEREBYX Fosphenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131028 NDA NDA020450 Pfizer Laboratories Div Pfizer Inc FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0069-5800_84580d57-01ac-4882-bcd5-2fd083378997 0069-5800 HUMAN PRESCRIPTION DRUG Tikosyn dofetilide CAPSULE ORAL 19991001 NDA NDA020931 Pfizer Laboratories Div Pfizer Inc DOFETILIDE .125 mg/1 Antiarrhythmic [EPC] N 20181231 0069-5810_84580d57-01ac-4882-bcd5-2fd083378997 0069-5810 HUMAN PRESCRIPTION DRUG Tikosyn dofetilide CAPSULE ORAL 19991001 NDA NDA020931 Pfizer Laboratories Div Pfizer Inc DOFETILIDE .25 mg/1 Antiarrhythmic [EPC] N 20181231 0069-5820_84580d57-01ac-4882-bcd5-2fd083378997 0069-5820 HUMAN PRESCRIPTION DRUG Tikosyn dofetilide CAPSULE ORAL 19991001 NDA NDA020931 Pfizer Laboratories Div Pfizer Inc DOFETILIDE .5 mg/1 Antiarrhythmic [EPC] N 20181231 0069-6001_efc6ed92-f87a-4b2e-9643-cc0f6be5e701 0069-6001 HUMAN PRESCRIPTION DRUG CEREBYX Fosphenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131028 NDA NDA020450 Pfizer Laboratories Div Pfizer Inc FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0069-8140_4cc9d49f-771a-468b-8230-09398cb8cbda 0069-8140 HUMAN PRESCRIPTION DRUG Xalkori CRIZOTINIB CAPSULE ORAL 20110826 NDA NDA202570 Pfizer Laboratories Div Pfizer Inc CRIZOTINIB 250 mg/1 Kinase Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Receptor Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 2B6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 1 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0069-8141_4cc9d49f-771a-468b-8230-09398cb8cbda 0069-8141 HUMAN PRESCRIPTION DRUG Xalkori CRIZOTINIB CAPSULE ORAL 20110826 NDA NDA202570 Pfizer Laboratories Div Pfizer Inc CRIZOTINIB 200 mg/1 Kinase Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Receptor Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 2B6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 1 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0069-9321_6d989a92-a292-4f20-bf5e-1b5b10fd9bea 0069-9321 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION INTRAVENOUS 20111222 ANDA ANDA200647 Pfizer Laboratories Div Pfizer Inc. FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 0071-0007_1d7044a0-7355-475b-9706-56f588b06f45 0071-0007 HUMAN PRESCRIPTION DRUG Dilantin Infatabs Phenytoin TABLET, CHEWABLE ORAL 19790226 ANDA ANDA084427 Parke-Davis Div of Pfizer Inc PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0071-0155_41086bad-322c-4d2f-aba8-f58d9552b72e 0071-0155 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Parke-Davis Div of Pfizer Inc ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0071-0156_41086bad-322c-4d2f-aba8-f58d9552b72e 0071-0156 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Parke-Davis Div of Pfizer Inc ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0071-0157_41086bad-322c-4d2f-aba8-f58d9552b72e 0071-0157 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Parke-Davis Div of Pfizer Inc ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0071-0158_41086bad-322c-4d2f-aba8-f58d9552b72e 0071-0158 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20000407 NDA NDA020702 Parke-Davis Div of Pfizer Inc ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0071-0220_d2a9be08-66c2-4816-ab83-44597accaa34 0071-0220 HUMAN PRESCRIPTION DRUG ACCURETIC quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19991228 NDA NDA020125 Parke-Davis Div of Pfizer Inc QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0071-0222_d2a9be08-66c2-4816-ab83-44597accaa34 0071-0222 HUMAN PRESCRIPTION DRUG ACCURETIC quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19991228 NDA NDA020125 Parke-Davis Div of Pfizer Inc QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0071-0223_d2a9be08-66c2-4816-ab83-44597accaa34 0071-0223 HUMAN PRESCRIPTION DRUG ACCURETIC quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19991228 NDA NDA020125 Parke-Davis Div of Pfizer Inc QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0071-0237_c0d3c234-48b9-4d20-adce-0365715b14dd 0071-0237 HUMAN PRESCRIPTION DRUG Zarontin Ethosuximide CAPSULE ORAL 20000922 NDA NDA012380 Parke-Davis Div of Pfizer Inc ETHOSUXIMIDE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0071-0350_0cee2696-2d79-4e66-919f-10563f612c0c 0071-0350 HUMAN PRESCRIPTION DRUG Nardil Phenelzine Sulfate TABLET, FILM COATED ORAL 19610609 NDA NDA011909 Parke-Davis Div of Pfizer Inc PHENELZINE SULFATE 15 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 0071-0369_7a489684-f204-4c54-b45c-bc9e6ba91f8e 0071-0369 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 Parke-Davis Div of Pfizer Inc PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0071-0401_c0bfa3e8-7b11-48b4-9ecc-b8e0811db583 0071-0401 HUMAN PRESCRIPTION DRUG Neurontin gabapentin TABLET, FILM COATED ORAL 19981009 NDA NDA020882 Parke-Davis Div of Pfizer Inc GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0071-0417_72e2e850-8653-47a6-b309-2cdeddf25d23 0071-0417 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Parke-Davis Div of Pfizer Inc NITROGLYCERIN .3 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0071-0418_72e2e850-8653-47a6-b309-2cdeddf25d23 0071-0418 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Parke-Davis Div of Pfizer Inc NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0071-0419_72e2e850-8653-47a6-b309-2cdeddf25d23 0071-0419 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Parke-Davis Div of Pfizer Inc NITROGLYCERIN .6 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0071-0513_c0bfa3e8-7b11-48b4-9ecc-b8e0811db583 0071-0513 HUMAN PRESCRIPTION DRUG Neurontin gabapentin TABLET, FILM COATED ORAL 19981009 NDA NDA020882 Parke-Davis Div of Pfizer Inc GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0071-0525_fe1649b6-8f71-467b-aad4-275615657668 0071-0525 HUMAN PRESCRIPTION DRUG Celontin methsuximide CAPSULE ORAL 19570208 NDA NDA010596 Parke-Davis Div of Pfizer Inc METHSUXIMIDE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0071-0527_5bf68301-48f6-4c30-b27e-91e9a74dc5d0 0071-0527 HUMAN PRESCRIPTION DRUG Accupril quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA NDA019885 Parke-Davis Div of Pfizer Inc QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0071-0530_5bf68301-48f6-4c30-b27e-91e9a74dc5d0 0071-0530 HUMAN PRESCRIPTION DRUG Accupril quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA NDA019885 Parke-Davis Div of Pfizer Inc QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0071-0532_5bf68301-48f6-4c30-b27e-91e9a74dc5d0 0071-0532 HUMAN PRESCRIPTION DRUG Accupril quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA NDA019885 Parke-Davis Div of Pfizer Inc QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0071-0535_5bf68301-48f6-4c30-b27e-91e9a74dc5d0 0071-0535 HUMAN PRESCRIPTION DRUG Accupril quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA NDA019885 Parke-Davis Div of Pfizer Inc QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0071-0737_00b05ec6-8985-48fc-8814-f8c12dd09639 0071-0737 HUMAN PRESCRIPTION DRUG Lopid gemfibrozil TABLET, FILM COATED ORAL 20040330 NDA NDA018422 Parke-Davis Div of Pfizer Inc GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 0071-0803_c0bfa3e8-7b11-48b4-9ecc-b8e0811db583 0071-0803 HUMAN PRESCRIPTION DRUG Neurontin gabapentin CAPSULE ORAL 19931230 NDA NDA020235 Parke-Davis Div of Pfizer Inc GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0071-0805_c0bfa3e8-7b11-48b4-9ecc-b8e0811db583 0071-0805 HUMAN PRESCRIPTION DRUG Neurontin gabapentin CAPSULE ORAL 19931230 NDA NDA020235 Parke-Davis Div of Pfizer Inc GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0071-0806_c0bfa3e8-7b11-48b4-9ecc-b8e0811db583 0071-0806 HUMAN PRESCRIPTION DRUG Neurontin gabapentin CAPSULE ORAL 19931230 NDA NDA020235 Parke-Davis Div of Pfizer Inc GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0071-1012_9b679f1c-9130-4b05-a8dd-1b598a2be10c 0071-1012 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 25 mg/1 CV N 20191231 0071-1013_9b679f1c-9130-4b05-a8dd-1b598a2be10c 0071-1013 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 50 mg/1 N 20191231 0071-1014_9b679f1c-9130-4b05-a8dd-1b598a2be10c 0071-1014 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 75 mg/1 N 20191231 0071-1015_9b679f1c-9130-4b05-a8dd-1b598a2be10c 0071-1015 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 100 mg/1 N 20191231 0071-1016_9b679f1c-9130-4b05-a8dd-1b598a2be10c 0071-1016 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 150 mg/1 N 20191231 0071-1017_9b679f1c-9130-4b05-a8dd-1b598a2be10c 0071-1017 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 200 mg/1 N 20191231 0071-1018_9b679f1c-9130-4b05-a8dd-1b598a2be10c 0071-1018 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 300 mg/1 N 20191231 0071-1019_9b679f1c-9130-4b05-a8dd-1b598a2be10c 0071-1019 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Parke-Davis Div of Pfizer Inc PREGABALIN 225 mg/1 N 20191231 0071-1020_9b679f1c-9130-4b05-a8dd-1b598a2be10c 0071-1020 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN SOLUTION ORAL 20100104 NDA NDA022488 Parke-Davis Div of Pfizer Inc PREGABALIN 20 mg/mL N 20191231 0071-1026_995af16e-4253-4d19-8206-cf7a86cab719 0071-1026 HUMAN PRESCRIPTION DRUG Lyrica CR PREGABALIN TABLET, FILM COATED, EXTENDED RELEASE ORAL 20180101 NDA NDA209501 Parke-Davis Div of Pfizer Inc PREGABALIN 82.5 mg/1 N 20191231 0071-1027_995af16e-4253-4d19-8206-cf7a86cab719 0071-1027 HUMAN PRESCRIPTION DRUG Lyrica CR PREGABALIN TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160101 NDA NDA209501 Parke-Davis Div of Pfizer Inc PREGABALIN 165 mg/1 N 20191231 0071-1029_995af16e-4253-4d19-8206-cf7a86cab719 0071-1029 HUMAN PRESCRIPTION DRUG Lyrica CR PREGABALIN TABLET, FILM COATED, EXTENDED RELEASE ORAL 20180101 NDA NDA209501 Parke-Davis Div of Pfizer Inc PREGABALIN 330 mg/1 N 20191231 0071-2012_c0bfa3e8-7b11-48b4-9ecc-b8e0811db583 0071-2012 HUMAN PRESCRIPTION DRUG Neurontin gabapentin SOLUTION ORAL 20000302 NDA NDA021129 Parke-Davis Div of Pfizer Inc GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0071-2214_c79d0e7b-afd6-4a64-b67d-4c26bdd13275 0071-2214 HUMAN PRESCRIPTION DRUG Dilantin-125 Phenytoin SUSPENSION ORAL 19530106 NDA NDA008762 Parke-Davis Div of Pfizer Inc PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0071-2418_db4f89ce-62a4-41de-91d0-fe691c7b38ba 0071-2418 HUMAN PRESCRIPTION DRUG Zarontin Ethosuximide SOLUTION ORAL 20020227 ANDA ANDA080258 Parke-Davis Div of Pfizer Inc ETHOSUXIMIDE 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0071-3740_7a489684-f204-4c54-b45c-bc9e6ba91f8e 0071-3740 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 Parke-Davis Div of Pfizer Inc PHENYTOIN SODIUM 30 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0074-0033_5521da2c-ac4a-401b-b195-a1fbb5ce0c9f 0074-0033 HUMAN PRESCRIPTION DRUG Zinbryta Daclizumab INJECTION, SOLUTION SUBCUTANEOUS 20160527 BLA BLA761029 Abbvie DACLIZUMAB 150 mg/mL Interleukin 2 Receptor Antagonists [MoA],Interleukin 2 Receptor-directed Antibody Interactions [MoA],Interleukin-2 Receptor Blocking Antibody [EPC] N 20181231 0074-0034_5521da2c-ac4a-401b-b195-a1fbb5ce0c9f 0074-0034 HUMAN PRESCRIPTION DRUG Zinbryta Pen Daclizumab INJECTION, SOLUTION SUBCUTANEOUS 20170526 BLA BLA761029 Abbvie DACLIZUMAB 150 mg/mL Interleukin 2 Receptor Antagonists [MoA],Interleukin 2 Receptor-directed Antibody Interactions [MoA],Interleukin-2 Receptor Blocking Antibody [EPC] N 20181231 0074-0063_893b3081-ba87-1fe0-6ac6-aceb5bbc70c7 0074-0063 HUMAN PRESCRIPTION DRUG Viekira XR Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir KIT 20160722 NDA NDA208624 AbbVie Inc. N 20181231 0074-0067_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-0067 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20161017 BLA BLA125057 AbbVie Inc. N 20181231 0074-0124_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-0124 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20170421 BLA BLA125057 AbbVie Inc. N 20181231 0074-0243_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-0243 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20151123 BLA BLA125057 AbbVie Inc. N 20181231 0074-0522_3f1cb62c-b0a7-e1fc-b2ff-88901b1ad32a 0074-0522 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 AbbVie Inc. LOPINAVIR; RITONAVIR 100; 25 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0074-0541_f3e2917a-32f1-bff7-0bc0-0a4c3cdd2c22 0074-0541 HUMAN PRESCRIPTION DRUG Gengraf Cyclosporine CAPSULE ORAL 20160620 ANDA ANDA065003 AbbVie Inc. CYCLOSPORINE 50 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0074-0554_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-0554 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20160309 BLA BLA125057 AbbVie Inc. N 20181231 0074-0561_a4b35f32-cd9f-957c-6a13-fca65c28fd23 0074-0561 HUMAN PRESCRIPTION DRUG Venclexta Venetoclax TABLET, FILM COATED ORAL 20160411 NDA NDA208573 AbbVie Inc. VENETOCLAX 10 mg/1 BCL-2 Inhibitor [EPC],Increased Cellular Death [PE],P-Glycoprotein Inhibitors [MoA] N 20181231 0074-0566_a4b35f32-cd9f-957c-6a13-fca65c28fd23 0074-0566 HUMAN PRESCRIPTION DRUG Venclexta Venetoclax TABLET, FILM COATED ORAL 20160411 NDA NDA208573 AbbVie Inc. VENETOCLAX 50 mg/1 BCL-2 Inhibitor [EPC],Increased Cellular Death [PE],P-Glycoprotein Inhibitors [MoA] N 20181231 0074-0576_a4b35f32-cd9f-957c-6a13-fca65c28fd23 0074-0576 HUMAN PRESCRIPTION DRUG Venclexta Venetoclax TABLET, FILM COATED ORAL 20160411 NDA NDA208573 AbbVie Inc. VENETOCLAX 100 mg/1 BCL-2 Inhibitor [EPC],Increased Cellular Death [PE],P-Glycoprotein Inhibitors [MoA] N 20181231 0074-0579_a4b35f32-cd9f-957c-6a13-fca65c28fd23 0074-0579 HUMAN PRESCRIPTION DRUG Venclexta Venetoclax KIT 20160411 NDA NDA208573 AbbVie Inc. N 20181231 0074-0616_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-0616 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20170428 BLA BLA125057 AbbVie Inc. N 20181231 0074-0817_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-0817 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20170428 BLA BLA125057 AbbVie Inc. N 20181231 0074-1040_76876f21-08b6-9dfe-8dda-901496585239 0074-1040 HUMAN PRESCRIPTION DRUG Survanta Beractant SUSPENSION ENDOTRACHEAL 19910701 NDA NDA020032 AbbVie Inc. BERACTANT 25 mg/mL Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfactant Activity [MoA] N 20181231 0074-1052_a1371df0-8ff8-0b59-fb31-364cdc4641eb 0074-1052 HUMAN PRESCRIPTION DRUG Lupaneta Pack leuprolide acetate and norethindrone acetate KIT 20130701 NDA NDA203696 AbbVie Inc. N 20181231 0074-1053_2441c6ed-aac4-677b-09be-d188a02116d8 0074-1053 HUMAN PRESCRIPTION DRUG Lupaneta Pack leuprolide acetate and norethindrone acetate KIT 20130701 NDA NDA203696 AbbVie Inc. N 20181231 0074-1539_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-1539 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20170421 BLA BLA125057 AbbVie Inc. N 20181231 0074-1564_6fd04f96-6b5e-4cd8-9313-63877dd11f51 0074-1564 HUMAN PRESCRIPTION DRUG Depacon Valproate Sodium INJECTION INTRAVENOUS 19961230 20191101 NDA NDA020593 AbbVie Inc. VALPROATE SODIUM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0074-1658_093873ff-4f54-1aeb-bb3f-0c27d18c3e18 0074-1658 HUMAN PRESCRIPTION DRUG Zemplar Paricalcitol INJECTION, SOLUTION INTRAVENOUS 19980417 NDA NDA020819 AbbVie Inc. PARICALCITOL 5 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0074-1940_73466409-f63b-1b70-abfd-77882a881502 0074-1940 HUMAN PRESCRIPTION DRUG Norvir Ritonavir SOLUTION ORAL 20100506 NDA NDA020659 AbbVie Inc. RITONAVIR 80 mg/mL UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0074-2108_4f3e4b5a-ce42-9722-9ef8-517bf148eb2b 0074-2108 HUMAN PRESCRIPTION DRUG Lupron Depot-PED leuprolide acetate KIT 19930416 NDA NDA020263 AbbVie Inc. N 20181231 0074-2282_4f3e4b5a-ce42-9722-9ef8-517bf148eb2b 0074-2282 HUMAN PRESCRIPTION DRUG Lupron Depot-PED leuprolide acetate KIT 19930416 NDA NDA020263 AbbVie Inc. N 20181231 0074-2440_4f3e4b5a-ce42-9722-9ef8-517bf148eb2b 0074-2440 HUMAN PRESCRIPTION DRUG Lupron Depot-PED leuprolide acetate KIT 19930416 NDA NDA020263 AbbVie Inc. N 20181231 0074-2540_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-2540 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20161017 BLA BLA125057 AbbVie Inc. N 20181231 0074-2625_4db642da-6638-93f8-bc9d-b99fde81a676 0074-2625 HUMAN PRESCRIPTION DRUG Mavyret Glecaprevir and Pibrentasvir TABLET, FILM COATED ORAL 20170803 NDA NDA209394 AbbVie Inc. PIBRENTASVIR; GLECAPREVIR 40; 100 mg/1; mg/1 Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],UGT1A1 Inhibitors [MoA],Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],HCV NS3/4A Protease Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],UGT1A1 Inhibitors [MoA] N 20181231 0074-3005_6f5954d6-78fe-dfae-5e2f-e8b8b510b887 0074-3005 HUMAN PRESCRIPTION DRUG Advicor niacin and lovastatin TABLET, EXTENDED RELEASE ORAL 20011217 20180331 NDA NDA021249 AbbVie Inc. NIACIN; LOVASTATIN 500; 20 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0074-3012_af475c44-a3fb-9ab0-a07a-9168e6e841fb 0074-3012 HUMAN PRESCRIPTION DRUG Duopa Carbidopa and Levodopa SUSPENSION ENTERAL 20150115 NDA NDA203952 AbbVie Inc. LEVODOPA; CARBIDOPA 20; 4.63 mg/mL; mg/mL Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0074-3023_7cd6d8e9-384e-06fb-3316-16b0553c4eb5 0074-3023 HUMAN PRESCRIPTION DRUG K-Tab Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19800609 NDA NDA018279 AbbVie Inc. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0074-3041_4291bd63-fe87-4366-a8e8-eaff1db3a76c 0074-3041 HUMAN PRESCRIPTION DRUG Vicodin Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120910 ANDA ANDA040658 AbbVie Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0074-3043_4291bd63-fe87-4366-a8e8-eaff1db3a76c 0074-3043 HUMAN PRESCRIPTION DRUG Vicodin ES Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120910 ANDA ANDA040658 AbbVie Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0074-3045_5be08c5b-24f9-43b0-bb9d-21b822619fd3 0074-3045 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 AbbVie Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 0074-3054_4291bd63-fe87-4366-a8e8-eaff1db3a76c 0074-3054 HUMAN PRESCRIPTION DRUG Vicodin HP Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120910 ANDA ANDA040658 AbbVie Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0074-3058_7cd6d8e9-384e-06fb-3316-16b0553c4eb5 0074-3058 HUMAN PRESCRIPTION DRUG K-Tab Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19800609 NDA NDA018279 AbbVie Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0074-3061_5be08c5b-24f9-43b0-bb9d-21b822619fd3 0074-3061 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 AbbVie Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 0074-3062_5be08c5b-24f9-43b0-bb9d-21b822619fd3 0074-3062 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 AbbVie Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 0074-3063_5be08c5b-24f9-43b0-bb9d-21b822619fd3 0074-3063 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 AbbVie Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 0074-3064_5be08c5b-24f9-43b0-bb9d-21b822619fd3 0074-3064 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 AbbVie Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 0074-3069_5be08c5b-24f9-43b0-bb9d-21b822619fd3 0074-3069 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 AbbVie Inc. DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 0074-3074_bda39387-b334-24be-2b6a-8e6857f84b79 0074-3074 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100629 NDA NDA020381 AbbVie Inc. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 0074-3079_bda39387-b334-24be-2b6a-8e6857f84b79 0074-3079 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970728 NDA NDA020381 AbbVie Inc. NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 0074-3080_bda39387-b334-24be-2b6a-8e6857f84b79 0074-3080 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970728 NDA NDA020381 AbbVie Inc. NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 0074-3082_559c1962-7dad-77eb-f145-7f6cc3a38c6e 0074-3082 HUMAN PRESCRIPTION DRUG Technivie Ombitasvir and Paritaprevir and Ritonavir KIT 20150724 NDA NDA207931 AbbVie Inc. N 20181231 0074-3093_2395168e-8196-e69c-53df-3ff2cd9611a7 0074-3093 HUMAN PRESCRIPTION DRUG Viekira Pak Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir KIT 20141219 NDA NDA206619 AbbVie Inc. N 20181231 0074-3108_f3e2917a-32f1-bff7-0bc0-0a4c3cdd2c22 0074-3108 HUMAN PRESCRIPTION DRUG Gengraf Cyclosporine CAPSULE ORAL 20151101 ANDA ANDA065003 AbbVie Inc. CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0074-3109_f3e2917a-32f1-bff7-0bc0-0a4c3cdd2c22 0074-3109 HUMAN PRESCRIPTION DRUG Gengraf Cyclosporine CAPSULE ORAL 20151101 ANDA ANDA065003 AbbVie Inc. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0074-3161_a334aec5-8e67-3541-088c-3afc4c2c4e33 0074-3161 HUMAN PRESCRIPTION DRUG Trilipix Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20160912 NDA NDA022224 AbbVie Inc. FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0074-3162_a334aec5-8e67-3541-088c-3afc4c2c4e33 0074-3162 HUMAN PRESCRIPTION DRUG Trilipix Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20160912 NDA NDA022224 AbbVie Inc. FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0074-3173_03b556c9-c2d4-b8c4-c548-676db69a3151 0074-3173 HUMAN PRESCRIPTION DRUG Tricor Fenofibrate TABLET ORAL 20160205 NDA NDA021656 AbbVie Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0074-3189_03b556c9-c2d4-b8c4-c548-676db69a3151 0074-3189 HUMAN PRESCRIPTION DRUG Tricor Fenofibrate TABLET ORAL 20160205 NDA NDA021656 AbbVie Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0074-3197_38d523ed-14fa-b679-0aa1-2d73b5afb682 0074-3197 HUMAN PRESCRIPTION DRUG Moderiba Ribavirin TABLET, FILM COATED ORAL 20140120 ANDA ANDA077456 AbbVie Inc. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20191231 0074-3224_38d523ed-14fa-b679-0aa1-2d73b5afb682 0074-3224 HUMAN PRESCRIPTION DRUG Moderiba Ribavirin KIT 20140120 ANDA ANDA077456 AbbVie Inc. N 20191231 0074-3239_38d523ed-14fa-b679-0aa1-2d73b5afb682 0074-3239 HUMAN PRESCRIPTION DRUG Moderiba Ribavirin TABLET, FILM COATED ORAL 20140120 ANDA ANDA077456 AbbVie Inc. RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20191231 0074-3265_bda39387-b334-24be-2b6a-8e6857f84b79 0074-3265 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170919 NDA NDA020381 AbbVie Inc. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 0074-3271_38d523ed-14fa-b679-0aa1-2d73b5afb682 0074-3271 HUMAN PRESCRIPTION DRUG Moderiba Ribavirin KIT 20140120 ANDA ANDA077456 AbbVie Inc. N 20191231 0074-3274_bda39387-b334-24be-2b6a-8e6857f84b79 0074-3274 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170919 NDA NDA020381 AbbVie Inc. NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 0074-3275_bda39387-b334-24be-2b6a-8e6857f84b79 0074-3275 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170919 NDA NDA020381 AbbVie Inc. NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 0074-3278_7cd6d8e9-384e-06fb-3316-16b0553c4eb5 0074-3278 HUMAN PRESCRIPTION DRUG K-Tab Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170601 NDA NDA018279 AbbVie Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0074-3282_38d523ed-14fa-b679-0aa1-2d73b5afb682 0074-3282 HUMAN PRESCRIPTION DRUG Moderiba Ribavirin TABLET, FILM COATED ORAL 20140120 ANDA ANDA077456 AbbVie Inc. RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20191231 0074-3287_95783c64-ca5e-5b93-18c9-e1cae9997778 0074-3287 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19961022 NDA NDA020591 AbbVie Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 180 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0074-3288_95783c64-ca5e-5b93-18c9-e1cae9997778 0074-3288 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19961022 20180228 NDA NDA020591 AbbVie Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 1; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0074-3289_95783c64-ca5e-5b93-18c9-e1cae9997778 0074-3289 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19961022 NDA NDA020591 AbbVie Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0074-3290_95783c64-ca5e-5b93-18c9-e1cae9997778 0074-3290 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19961022 NDA NDA020591 AbbVie Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0074-3333_73466409-f63b-1b70-abfd-77882a881502 0074-3333 HUMAN PRESCRIPTION DRUG Norvir Ritonavir TABLET, FILM COATED ORAL 20100506 NDA NDA022417 AbbVie Inc. RITONAVIR 100 mg/1 UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0074-3346_cf4a9ceb-9d8f-8d6d-745b-e5029364f94d 0074-3346 HUMAN PRESCRIPTION DRUG Lupron Depot leuprolide acetate KIT 19951222 NDA NDA020517 AbbVie Inc. N 20181231 0074-3399_73466409-f63b-1b70-abfd-77882a881502 0074-3399 HUMAN PRESCRIPTION DRUG Norvir Ritonavir POWDER ORAL 20170607 NDA NDA209512 AbbVie Inc. RITONAVIR 100 mg/1 UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0074-3473_cf4a9ceb-9d8f-8d6d-745b-e5029364f94d 0074-3473 HUMAN PRESCRIPTION DRUG Lupron Depot leuprolide acetate KIT 19951222 NDA NDA020517 AbbVie Inc. N 20181231 0074-3641_fff466be-008d-f964-7bde-1adc40867394 0074-3641 HUMAN PRESCRIPTION DRUG Lupron Depot leuprolide acetate KIT 19901022 NDA NDA020011 AbbVie Inc. N 20181231 0074-3642_cf4a9ceb-9d8f-8d6d-745b-e5029364f94d 0074-3642 HUMAN PRESCRIPTION DRUG Lupron Depot leuprolide acetate KIT 19890126 NDA NDA019732 AbbVie Inc. N 20181231 0074-3663_d9ee98cb-5756-43ac-0925-993d8661ad04 0074-3663 HUMAN PRESCRIPTION DRUG Lupron Depot leuprolide acetate KIT 20101108 NDA NDA020708 AbbVie Inc. N 20181231 0074-3683_cf4a9ceb-9d8f-8d6d-745b-e5029364f94d 0074-3683 HUMAN PRESCRIPTION DRUG Lupron Depot leuprolide acetate KIT 19951222 NDA NDA020517 AbbVie Inc. N 20181231 0074-3727_0de15097-593e-3fef-69fe-33df9f250ff8 0074-3727 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 0074-3753_78cb2405-3427-9c89-c252-9fa5dba1a177 0074-3753 HUMAN PRESCRIPTION DRUG Tridione Trimethadione TABLET, CHEWABLE ORAL 19460125 NDA NDA005856 AbbVie Inc. TRIMETHADIONE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0074-3779_4f3e4b5a-ce42-9722-9ef8-517bf148eb2b 0074-3779 HUMAN PRESCRIPTION DRUG Lupron Depot-PED leuprolide acetate KIT 19930416 NDA NDA020263 AbbVie Inc. N 20181231 0074-3797_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-3797 HUMAN PRESCRIPTION DRUG Humira Adalimumab INJECTION, SOLUTION SUBCUTANEOUS 20021230 BLA BLA125057 AbbVie Inc. ADALIMUMAB 40 mg/.8mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 0074-3799_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-3799 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20021231 BLA BLA125057 AbbVie Inc. N 20181231 0074-3826_71b8f83d-abe7-01c7-b90d-bdaaf21caeb7 0074-3826 HUMAN PRESCRIPTION DRUG Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20000804 NDA NDA021168 AbbVie Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0074-3956_3f1cb62c-b0a7-e1fc-b2ff-88901b1ad32a 0074-3956 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir SOLUTION ORAL 20100618 NDA NDA021251 AbbVie Inc. LOPINAVIR; RITONAVIR 80; 20 mg/mL; mg/mL HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0074-4314_474b4ea3-0e5e-5b45-ea3d-2a74ee848c18 0074-4314 HUMAN PRESCRIPTION DRUG Zemplar Paricalcitol CAPSULE, LIQUID FILLED ORAL 20100614 NDA NDA021606 AbbVie Inc. PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20191231 0074-4317_474b4ea3-0e5e-5b45-ea3d-2a74ee848c18 0074-4317 HUMAN PRESCRIPTION DRUG Zemplar Paricalcitol CAPSULE, LIQUID FILLED ORAL 20100614 NDA NDA021606 AbbVie Inc. PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20191231 0074-4339_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-4339 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20060623 BLA BLA125057 AbbVie Inc. N 20181231 0074-4341_0de15097-593e-3fef-69fe-33df9f250ff8 0074-4341 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 0074-4365_1a74ec2a-f5a4-3296-d411-1c10ab3ae676 0074-4365 HUMAN PRESCRIPTION DRUG Mivacron Mivacurium Chloride SOLUTION INTRAVENOUS 20150130 NDA NDA020098 AbbVie Inc. MIVACURIUM CHLORIDE 2 mg/mL N 20181231 0074-4378_598c679e-4b8f-19e5-f185-94d06cff19c9 0074-4378 HUMAN PRESCRIPTION DRUG Nimbex Cisatracurium besylate INJECTION INTRAVENOUS 20101209 NDA NDA020551 AbbVie Inc. CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0074-4378_7b74aa09-76f3-02c3-7b05-f8bec76441bb 0074-4378 HUMAN PRESCRIPTION DRUG Nimbex Cisatracurium besylate INJECTION INTRAVENOUS 20101209 NDA NDA020551 AbbVie Inc. CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0074-4380_598c679e-4b8f-19e5-f185-94d06cff19c9 0074-4380 HUMAN PRESCRIPTION DRUG Nimbex Cisatracurium besylate INJECTION INTRAVENOUS 20101209 NDA NDA020551 AbbVie Inc. CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0074-4380_7b74aa09-76f3-02c3-7b05-f8bec76441bb 0074-4380 HUMAN PRESCRIPTION DRUG Nimbex Cisatracurium besylate INJECTION INTRAVENOUS 20101209 NDA NDA020551 AbbVie Inc. CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0074-4382_598c679e-4b8f-19e5-f185-94d06cff19c9 0074-4382 HUMAN PRESCRIPTION DRUG Nimbex Cisatracurium besylate INJECTION INTRAVENOUS 19951215 NDA NDA020551 AbbVie Inc. CISATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0074-4382_7b74aa09-76f3-02c3-7b05-f8bec76441bb 0074-4382 HUMAN PRESCRIPTION DRUG Nimbex Cisatracurium besylate INJECTION INTRAVENOUS 19951215 NDA NDA020551 AbbVie Inc. CISATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0074-4456_14d52736-b223-d525-dfb2-a27c808adece 0074-4456 HUMAN PRESCRIPTION DRUG Ultane Sevoflurane LIQUID RESPIRATORY (INHALATION) 19950607 NDA NDA020478 AbbVie Inc. SEVOFLURANE 250 mL/250mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 0074-4456_e017fe95-1057-4109-3b4b-5d30b4d30edb 0074-4456 HUMAN PRESCRIPTION DRUG Ultane Sevoflurane LIQUID RESPIRATORY (INHALATION) 19950607 NDA NDA020478 AbbVie Inc. SEVOFLURANE 250 mL/250mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 0074-4552_0de15097-593e-3fef-69fe-33df9f250ff8 0074-4552 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 0074-4637_093873ff-4f54-1aeb-bb3f-0c27d18c3e18 0074-4637 HUMAN PRESCRIPTION DRUG Zemplar Paricalcitol INJECTION, SOLUTION INTRAVENOUS 19980417 NDA NDA020819 AbbVie Inc. PARICALCITOL 2 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0074-5182_0de15097-593e-3fef-69fe-33df9f250ff8 0074-5182 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 0074-5681_f2ab3183-3aec-c0b8-88c1-61d234095736 0074-5681 HUMAN PRESCRIPTION DRUG Depakene Valproic Acid CAPSULE, LIQUID FILLED ORAL 19780228 20191011 NDA NDA018081 AbbVie Inc. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0074-5682_f2ab3183-3aec-c0b8-88c1-61d234095736 0074-5682 HUMAN PRESCRIPTION DRUG Depakene Valproic Acid SOLUTION ORAL 19780228 20190717 NDA NDA018082 AbbVie Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0074-6114_54cb3a38-3bdb-eb31-d853-8ef76d3b0c90 0074-6114 HUMAN PRESCRIPTION DRUG Depakote Sprinkles Divalproex Sodium CAPSULE ORAL 19890912 NDA NDA019680 AbbVie Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0074-6122_03b556c9-c2d4-b8c4-c548-676db69a3151 0074-6122 HUMAN PRESCRIPTION DRUG Tricor Fenofibrate TABLET ORAL 20041105 NDA NDA021656 AbbVie Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0074-6123_03b556c9-c2d4-b8c4-c548-676db69a3151 0074-6123 HUMAN PRESCRIPTION DRUG Tricor Fenofibrate TABLET ORAL 20041105 NDA NDA021656 AbbVie Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0074-6212_261c9d7a-d60a-fea8-3be1-8743475159fa 0074-6212 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 19830310 NDA NDA018723 AbbVie Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0074-6214_261c9d7a-d60a-fea8-3be1-8743475159fa 0074-6214 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 19830310 NDA NDA018723 AbbVie Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0074-6215_261c9d7a-d60a-fea8-3be1-8743475159fa 0074-6215 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 19830310 NDA NDA018723 AbbVie Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0074-6347_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-6347 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20140923 BLA BLA125057 AbbVie Inc. N 20181231 0074-6594_0de15097-593e-3fef-69fe-33df9f250ff8 0074-6594 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 0074-6624_0de15097-593e-3fef-69fe-33df9f250ff8 0074-6624 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 0074-6633_0778b73b-52c0-f0e5-0989-8c1376b3f69c 0074-6633 HUMAN PRESCRIPTION DRUG Norvir Ritonavir CAPSULE ORAL 20100506 NDA NDA020945 AbbVie Inc. RITONAVIR 100 mg/1 UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0074-6799_3f1cb62c-b0a7-e1fc-b2ff-88901b1ad32a 0074-6799 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 AbbVie Inc. LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0074-7068_0de15097-593e-3fef-69fe-33df9f250ff8 0074-7068 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 0074-7069_0de15097-593e-3fef-69fe-33df9f250ff8 0074-7069 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 0074-7070_0de15097-593e-3fef-69fe-33df9f250ff8 0074-7070 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 0074-7126_71b8f83d-abe7-01c7-b90d-bdaaf21caeb7 0074-7126 HUMAN PRESCRIPTION DRUG Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20000804 NDA NDA021168 AbbVie Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0074-7148_0de15097-593e-3fef-69fe-33df9f250ff8 0074-7148 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020224 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 0074-7149_0de15097-593e-3fef-69fe-33df9f250ff8 0074-7149 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 300 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 0074-7269_6afc8276-8892-ec81-b3d8-84c2d5e01601 0074-7269 HUMAN PRESCRIPTION DRUG Gengraf Cyclosporine SOLUTION ORAL 20100525 ANDA ANDA065025 AbbVie Inc. CYCLOSPORINE 100 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0074-7804_7cd6d8e9-384e-06fb-3316-16b0553c4eb5 0074-7804 HUMAN PRESCRIPTION DRUG K-Tab Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19800609 NDA NDA018279 AbbVie Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0074-9189_a334aec5-8e67-3541-088c-3afc4c2c4e33 0074-9189 HUMAN PRESCRIPTION DRUG Trilipix Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20081215 NDA NDA022224 AbbVie Inc. FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0074-9296_0de15097-593e-3fef-69fe-33df9f250ff8 0074-9296 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 AbbVie Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 0074-9374_5deb7e54-1b72-3a27-2a11-c23edab19b7f 0074-9374 HUMAN PRESCRIPTION DRUG Humira Adalimumab KIT 20080221 BLA BLA125057 AbbVie Inc. N 20181231 0074-9642_a334aec5-8e67-3541-088c-3afc4c2c4e33 0074-9642 HUMAN PRESCRIPTION DRUG Trilipix Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20081215 NDA NDA022224 AbbVie Inc. FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0074-9694_4f3e4b5a-ce42-9722-9ef8-517bf148eb2b 0074-9694 HUMAN PRESCRIPTION DRUG Lupron Depot-PED leuprolide acetate KIT 19930416 NDA NDA020263 AbbVie Inc. N 20181231 0075-0016_594ad44c-9c5d-47ad-b596-f667476a6b2f 0075-0016 HUMAN PRESCRIPTION DRUG DDAVP Desmopressin Acetate TABLET ORAL 19950906 NDA NDA019955 sanofi-aventis U.S. LLC DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] E 20171231 0075-0026_594ad44c-9c5d-47ad-b596-f667476a6b2f 0075-0026 HUMAN PRESCRIPTION DRUG DDAVP Desmopressin Acetate TABLET ORAL 19950906 NDA NDA019955 sanofi-aventis U.S. LLC DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] E 20171231 0075-0620_a238b14d-723c-49f0-8a46-4dbf54ed49f6 0075-0620 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080312 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-0620_eff9aa73-4e3a-4745-be42-3d0bff41a3b6 0075-0620 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-0621_a238b14d-723c-49f0-8a46-4dbf54ed49f6 0075-0621 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080417 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-0621_eff9aa73-4e3a-4745-be42-3d0bff41a3b6 0075-0621 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-0622_a238b14d-723c-49f0-8a46-4dbf54ed49f6 0075-0622 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080421 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-0622_eff9aa73-4e3a-4745-be42-3d0bff41a3b6 0075-0622 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-0623_a238b14d-723c-49f0-8a46-4dbf54ed49f6 0075-0623 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080421 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-0623_eff9aa73-4e3a-4745-be42-3d0bff41a3b6 0075-0623 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-0624_a238b14d-723c-49f0-8a46-4dbf54ed49f6 0075-0624 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080312 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-0624_eff9aa73-4e3a-4745-be42-3d0bff41a3b6 0075-0624 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-0626_a238b14d-723c-49f0-8a46-4dbf54ed49f6 0075-0626 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080421 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 300 mg/3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-0626_eff9aa73-4e3a-4745-be42-3d0bff41a3b6 0075-0626 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 300 mg/3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-1506_fd9979a4-63d0-4e2c-b012-240af67540eb 0075-1506 HUMAN PRESCRIPTION DRUG NASACORT AQ triamcinolone acetonide SPRAY, METERED NASAL 19960520 NDA NDA020468 sanofi-aventis U.S. LLC TRIAMCINOLONE ACETONIDE 55 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0075-2450_b1b1e14c-afba-44c1-a384-5aae6a624046 0075-2450 HUMAN PRESCRIPTION DRUG DDAVP Rhinal Tube Desmopressin Acetate SOLUTION NASAL 19780221 NDA NDA017922 sanofi-aventis U.S. LLC DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] E 20171231 0075-2451_5e30ba6d-ebb3-4950-b03a-7f1e946da982 0075-2451 HUMAN PRESCRIPTION DRUG DDAVP desmopressin acetate SOLUTION INTRAVENOUS 19840330 NDA NDA018938 sanofi-aventis U.S. LLC DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] E 20171231 0075-2452_517c673f-db39-4b91-bd86-eb35db5bea7f 0075-2452 HUMAN PRESCRIPTION DRUG DDAVP desmopressin acetate SOLUTION NASAL 19780221 NDA NDA017922 sanofi-aventis U.S. LLC DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] E 20171231 0075-2912_a238b14d-723c-49f0-8a46-4dbf54ed49f6 0075-2912 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080421 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-2912_eff9aa73-4e3a-4745-be42-3d0bff41a3b6 0075-2912 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-2915_a238b14d-723c-49f0-8a46-4dbf54ed49f6 0075-2915 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20080421 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-2915_eff9aa73-4e3a-4745-be42-3d0bff41a3b6 0075-2915 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-7700_3d0700b2-3cee-4276-8228-dbf608fb2612 0075-7700 HUMAN PRESCRIPTION DRUG Rilutek riluzole TABLET, FILM COATED ORAL 19951212 NDA NDA020599 sanofi-aventis U.S. LLC RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] E 20171231 0075-8003_ac6265cf-4409-4e1f-a8b0-cf178c767617 0075-8003 HUMAN PRESCRIPTION DRUG TAXOTERE Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100802 NDA NDA020449 sanofi-aventis U.S. LLC DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0075-8004_ac6265cf-4409-4e1f-a8b0-cf178c767617 0075-8004 HUMAN PRESCRIPTION DRUG TAXOTERE Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100802 NDA NDA020449 sanofi-aventis U.S. LLC DOCETAXEL 80 mg/4mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0075-8013_5315fe80-81da-4522-8732-98700aac2410 0075-8013 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-8014_5315fe80-81da-4522-8732-98700aac2410 0075-8014 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-8016_5315fe80-81da-4522-8732-98700aac2410 0075-8016 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-8018_5315fe80-81da-4522-8732-98700aac2410 0075-8018 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-8020_5315fe80-81da-4522-8732-98700aac2410 0075-8020 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-8022_5315fe80-81da-4522-8732-98700aac2410 0075-8022 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-8025_5315fe80-81da-4522-8732-98700aac2410 0075-8025 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0075-8030_5315fe80-81da-4522-8732-98700aac2410 0075-8030 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 sanofi-aventis U.S. LLC ENOXAPARIN SODIUM 300 mg/3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0076-0111_46e3b17c-53c9-6082-e054-00144ff8d46c 0076-0111 HUMAN PRESCRIPTION DRUG URIBEL Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate CAPSULE ORAL 20100801 UNAPPROVED DRUG OTHER Star Pharmaceuticals, LLC METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE 120; 40.8; 36; 10; .12 mg/1; mg/1; mg/1; mg/1; mg/1 Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0076-0901_45640779-4ba0-45fd-e054-00144ff88e88 0076-0901 HUMAN PRESCRIPTION DRUG Hyophen Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate TABLET ORAL 20100921 UNAPPROVED DRUG OTHER Star Pharmaceuticals, LLC METHENAMINE; BENZOIC ACID; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE 81.6; 9; 36.2; 10.8; .12 mg/1; mg/1; mg/1; mg/1; mg/1 Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 0076-0902_46e28dd2-fd8e-2044-e054-00144ff8d46c 0076-0902 HUMAN PRESCRIPTION DRUG Phosphasal Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate TABLET ORAL 20100921 UNAPPROVED DRUG OTHER Star Pharmaceuticals, LLC SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; HYOSCYAMINE SULFATE; METHYLENE BLUE; METHENAMINE 40.8; 36.2; .12; 10.8; 81.6 mg/1; mg/1; mg/1; mg/1; mg/1 Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 0076-0903_45c7c55c-ce7d-1f92-e054-00144ff8d46c 0076-0903 HUMAN PRESCRIPTION DRUG Ustell Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate CAPSULE ORAL 20100927 UNAPPROVED DRUG OTHER Star Pharmaceuticals LLC METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE 120; 40.8; 36; 10; .12 mg/1; mg/1; mg/1; mg/1; mg/1 Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 0078-0109_77eaef94-f3f5-4367-8ea2-b181d7be2da8 0078-0109 HUMAN PRESCRIPTION DRUG Sandimmune cyclosporine INJECTION INTRAVENOUS 19831114 NDA NDA050573 Novartis Pharmaceuticals Corporation CYCLOSPORINE 50 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0078-0110_77eaef94-f3f5-4367-8ea2-b181d7be2da8 0078-0110 HUMAN PRESCRIPTION DRUG Sandimmune cyclosporine SOLUTION ORAL 19831114 NDA NDA050574 Novartis Pharmaceuticals Corporation CYCLOSPORINE 100 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0078-0179_bb1804d5-07cf-4341-90bf-4c4eb2643380 0078-0179 HUMAN PRESCRIPTION DRUG Lamisil terbinafine hydrochloride TABLET ORAL 19960510 NDA NDA020539 Novartis Pharmaceuticals Corporation TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 0078-0180_99515a7e-2535-4fac-918f-9321515f8320 0078-0180 HUMAN PRESCRIPTION DRUG Sandostatin octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19881021 NDA NDA019667 Novartis Pharmaceuticals Corporation OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0078-0181_99515a7e-2535-4fac-918f-9321515f8320 0078-0181 HUMAN PRESCRIPTION DRUG Sandostatin octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19881021 NDA NDA019667 Novartis Pharmaceuticals Corporation OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0078-0182_99515a7e-2535-4fac-918f-9321515f8320 0078-0182 HUMAN PRESCRIPTION DRUG Sandostatin octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19881021 NDA NDA019667 Novartis Pharmaceuticals Corporation OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0078-0183_99515a7e-2535-4fac-918f-9321515f8320 0078-0183 HUMAN PRESCRIPTION DRUG Sandostatin octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19981021 NDA NDA019667 Novartis Pharmaceuticals Corporation OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0078-0184_99515a7e-2535-4fac-918f-9321515f8320 0078-0184 HUMAN PRESCRIPTION DRUG Sandostatin octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19881021 NDA NDA019667 Novartis Pharmaceuticals Corporation OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0078-0240_77eaef94-f3f5-4367-8ea2-b181d7be2da8 0078-0240 HUMAN PRESCRIPTION DRUG Sandimmune cyclosporine CAPSULE, LIQUID FILLED ORAL 19900302 NDA NDA050625 Novartis Pharmaceuticals Corporation CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0078-0241_77eaef94-f3f5-4367-8ea2-b181d7be2da8 0078-0241 HUMAN PRESCRIPTION DRUG Sandimmune cyclosporine CAPSULE, LIQUID FILLED ORAL 19900302 NDA NDA050625 Novartis Pharmaceuticals Corporation CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0078-0246_aaa50d67-4f11-455f-bc5d-0a1d91bdcea8 0078-0246 HUMAN PRESCRIPTION DRUG Neoral cyclosporine CAPSULE, LIQUID FILLED ORAL 19950714 NDA NDA050715 Novartis Pharmaceuticals Corporation CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0078-0248_aaa50d67-4f11-455f-bc5d-0a1d91bdcea8 0078-0248 HUMAN PRESCRIPTION DRUG Neoral cyclosporine CAPSULE, LIQUID FILLED ORAL 19950714 NDA NDA050715 Novartis Pharmaceuticals Corporation CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0078-0249_bb4a7ada-54cf-46d6-93f0-8fbd34e9ab26 0078-0249 HUMAN PRESCRIPTION DRUG Femara letrozole TABLET, FILM COATED ORAL 19970731 NDA NDA020726 Novartis Pharmaceuticals Corporation LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0078-0274_aaa50d67-4f11-455f-bc5d-0a1d91bdcea8 0078-0274 HUMAN PRESCRIPTION DRUG Neoral cyclosporine SOLUTION ORAL 19950714 NDA NDA050716 Novartis Pharmaceuticals Corporation CYCLOSPORINE 100 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0078-0314_77b3385c-4230-421c-9736-4d0835d12dea 0078-0314 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Novartis Pharmaceuticals Corporation VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0078-0315_77b3385c-4230-421c-9736-4d0835d12dea 0078-0315 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Novartis Pharmaceuticals Corporation VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0078-0323_775e8f94-ac01-4921-a7fd-fac1d68adc2f 0078-0323 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20000430 NDA NDA020823 Novartis Pharmaceuticals Corporation RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0078-0324_775e8f94-ac01-4921-a7fd-fac1d68adc2f 0078-0324 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20000430 NDA NDA020823 Novartis Pharmaceuticals Corporation RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0078-0325_775e8f94-ac01-4921-a7fd-fac1d68adc2f 0078-0325 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20000430 NDA NDA020823 Novartis Pharmaceuticals Corporation RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0078-0326_775e8f94-ac01-4921-a7fd-fac1d68adc2f 0078-0326 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20000430 NDA NDA020823 Novartis Pharmaceuticals Corporation RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0078-0327_d6c9f22e-562f-484b-acef-377ac0dff236 0078-0327 HUMAN PRESCRIPTION DRUG Comtan entacapone TABLET, FILM COATED ORAL 19991019 NDA NDA020796 Novartis Pharmaceuticals Corporation ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0078-0331_44e1d8f7-be69-4d69-b417-0125a8a6b4b9 0078-0331 HUMAN PRESCRIPTION DRUG Simulect basiliximab INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19980512 BLA BLA103764 Novartis Pharmaceuticals Corporation BASILIXIMAB 20 mg/5mL Interleukin 2 Receptor Antagonists [MoA],Interleukin 2 Receptor-directed Antibody Interactions [MoA],Interleukin-2 Receptor Blocking Antibody [EPC] N 20181231 0078-0337_81e7e1a2-6b2f-4c03-90f4-ba52d40ea014 0078-0337 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine TABLET, FILM COATED ORAL 20000130 NDA NDA021014 Novartis Pharmaceuticals Corporation OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0078-0343_99b7e483-02bd-4d16-a1ec-393fc7184004 0078-0343 HUMAN PRESCRIPTION DRUG Vivelle-Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 19990108 NDA NDA020538 Novartis Pharmaceuticals Corporation ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0078-0344_99b7e483-02bd-4d16-a1ec-393fc7184004 0078-0344 HUMAN PRESCRIPTION DRUG Vivelle-Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 19990108 NDA NDA020538 Novartis Pharmaceuticals Corporation ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0078-0345_99b7e483-02bd-4d16-a1ec-393fc7184004 0078-0345 HUMAN PRESCRIPTION DRUG Vivelle-Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 19990108 NDA NDA020538 Novartis Pharmaceuticals Corporation ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0078-0346_99b7e483-02bd-4d16-a1ec-393fc7184004 0078-0346 HUMAN PRESCRIPTION DRUG Vivelle-Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 19990108 NDA NDA020538 Novartis Pharmaceuticals Corporation ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0078-0351_778b42d2-8dfe-4d76-a16b-c354ecbedf31 0078-0351 HUMAN PRESCRIPTION DRUG Starlix nateglinide TABLET ORAL 20001204 NDA NDA021204 Novartis Pharmaceuticals Corporation NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0078-0352_778b42d2-8dfe-4d76-a16b-c354ecbedf31 0078-0352 HUMAN PRESCRIPTION DRUG Starlix nateglinide TABLET ORAL 20001204 NDA NDA021204 Novartis Pharmaceuticals Corporation NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0078-0354_99e5618b-b1a7-4b80-ade0-e891ca6b5ddf 0078-0354 HUMAN PRESCRIPTION DRUG Lescol XL fluvastatin sodium TABLET, EXTENDED RELEASE ORAL 20001006 NDA NDA021192 Novartis Pharmaceuticals Corporation FLUVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0078-0357_81e7e1a2-6b2f-4c03-90f4-ba52d40ea014 0078-0357 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine SUSPENSION ORAL 20010530 NDA NDA021285 Novartis Pharmaceuticals Corporation OXCARBAZEPINE 60 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0078-0358_eea97987-8b3f-465a-82e5-ddc791fa7d66 0078-0358 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Novartis Pharmaceuticals Corporation VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0078-0359_eea97987-8b3f-465a-82e5-ddc791fa7d66 0078-0359 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Novartis Pharmaceuticals Corporation VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0078-0360_eea97987-8b3f-465a-82e5-ddc791fa7d66 0078-0360 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Novartis Pharmaceuticals Corporation VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0078-0364_777600eb-081c-41de-af87-7bdda7c267b8 0078-0364 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0078-0365_99b7e483-02bd-4d16-a1ec-393fc7184004 0078-0365 HUMAN PRESCRIPTION DRUG Vivelle-Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 19990108 NDA NDA020538 Novartis Pharmaceuticals Corporation ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0078-0370_eee37f88-ec6a-4c30-b8aa-e2c71f93088c 0078-0370 HUMAN PRESCRIPTION DRUG Ritalin LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20020605 NDA NDA021284 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0371_eee37f88-ec6a-4c30-b8aa-e2c71f93088c 0078-0371 HUMAN PRESCRIPTION DRUG Ritalin LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20020605 NDA NDA021284 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0372_eee37f88-ec6a-4c30-b8aa-e2c71f93088c 0078-0372 HUMAN PRESCRIPTION DRUG Ritalin LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20020605 NDA NDA021284 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0379_777600eb-081c-41de-af87-7bdda7c267b8 0078-0379 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0078-0380_55c75ed8-eead-44a6-93bb-6a5010b2706d 0078-0380 HUMAN PRESCRIPTION DRUG Focalin dexmethylphenidate hydrochloride TABLET ORAL 20011130 NDA NDA021278 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0381_55c75ed8-eead-44a6-93bb-6a5010b2706d 0078-0381 HUMAN PRESCRIPTION DRUG Focalin dexmethylphenidate hydrochloride TABLET ORAL 20011130 NDA NDA021278 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0382_55c75ed8-eead-44a6-93bb-6a5010b2706d 0078-0382 HUMAN PRESCRIPTION DRUG Focalin dexmethylphenidate hydrochloride TABLET ORAL 20011130 NDA NDA021278 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0383_77b3385c-4230-421c-9736-4d0835d12dea 0078-0383 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Novartis Pharmaceuticals Corporation VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0078-0384_777600eb-081c-41de-af87-7bdda7c267b8 0078-0384 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0078-0385_1177b077-1906-4e70-8c38-356e242aa9a4 0078-0385 HUMAN PRESCRIPTION DRUG Myfortic mycophenolic acid TABLET, DELAYED RELEASE ORAL 20040227 NDA NDA050791 Novartis Pharmaceuticals Corporation MYCOPHENOLATE SODIUM 180 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 0078-0386_1177b077-1906-4e70-8c38-356e242aa9a4 0078-0386 HUMAN PRESCRIPTION DRUG Myfortic mycophenolic acid TABLET, DELAYED RELEASE ORAL 20040227 NDA NDA050791 Novartis Pharmaceuticals Corporation MYCOPHENOLATE SODIUM 360 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 0078-0387_993aa2f3-5d6f-4816-9315-5904cbc16757 0078-0387 HUMAN PRESCRIPTION DRUG Zometa zoledronic acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20010820 NDA NDA021223 Novartis Pharmaceuticals Corporation ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0078-0393_44e1d8f7-be69-4d69-b417-0125a8a6b4b9 0078-0393 HUMAN PRESCRIPTION DRUG Simulect basiliximab INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19980512 BLA BLA103764 Novartis Pharmaceuticals Corporation BASILIXIMAB 10 mg/2.5mL Interleukin 2 Receptor Antagonists [MoA],Interleukin 2 Receptor-directed Antibody Interactions [MoA],Interleukin-2 Receptor Blocking Antibody [EPC] N 20181231 0078-0400_44d120cd-7783-4139-97ab-174fd62fe101 0078-0400 HUMAN PRESCRIPTION DRUG Lopressor metoprolol tartrate INJECTION, SOLUTION INTRAVENOUS 19780115 NDA NDA018704 Novartis Pharmaceuticals Corporation METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0078-0401_22044114-64ab-4d37-92a8-d2086d77cc1b 0078-0401 HUMAN PRESCRIPTION DRUG Gleevec imatinib mesylate TABLET ORAL 20010515 NDA NDA021588 Novartis Pharmaceuticals Corporation IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 0078-0404_777600eb-081c-41de-af87-7bdda7c267b8 0078-0404 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0078-0405_777600eb-081c-41de-af87-7bdda7c267b8 0078-0405 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0078-0406_777600eb-081c-41de-af87-7bdda7c267b8 0078-0406 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0078-0407_5ae03a7a-7282-4998-b111-2d81718fc058 0078-0407 HUMAN PRESCRIPTION DRUG Stalevo carbidopa, levodopa, and entacapone TABLET, FILM COATED ORAL 20030611 NDA NDA021485 Novartis Pharmaceuticals Corporation CARBIDOPA; LEVODOPA; ENTACAPONE 12.5; 50; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0078-0408_5ae03a7a-7282-4998-b111-2d81718fc058 0078-0408 HUMAN PRESCRIPTION DRUG Stalevo carbidopa, levodopa, and entacapone TABLET, FILM COATED ORAL 20030611 NDA NDA021485 Novartis Pharmaceuticals Corporation CARBIDOPA; LEVODOPA; ENTACAPONE 25; 100; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0078-0409_5ae03a7a-7282-4998-b111-2d81718fc058 0078-0409 HUMAN PRESCRIPTION DRUG Stalevo carbidopa, levodopa, and entacapone TABLET, FILM COATED ORAL 20030611 NDA NDA021485 Novartis Pharmaceuticals Corporation CARBIDOPA; LEVODOPA; ENTACAPONE 37.5; 150; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0078-0414_37ee51de-0a4a-47de-9bf3-1d0f0a4ca7e8 0078-0414 HUMAN PRESCRIPTION DRUG Zortress everolimus TABLET ORAL 20100422 NDA NDA021560 Novartis Pharmaceuticals Corporation EVEROLIMUS .5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE] N 20191231 0078-0415_37ee51de-0a4a-47de-9bf3-1d0f0a4ca7e8 0078-0415 HUMAN PRESCRIPTION DRUG Zortress everolimus TABLET ORAL 20100422 NDA NDA021560 Novartis Pharmaceuticals Corporation EVEROLIMUS .75 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE] N 20191231 0078-0417_37ee51de-0a4a-47de-9bf3-1d0f0a4ca7e8 0078-0417 HUMAN PRESCRIPTION DRUG Zortress everolimus TABLET ORAL 20100422 NDA NDA021560 Novartis Pharmaceuticals Corporation EVEROLIMUS .25 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE] N 20191231 0078-0423_eea97987-8b3f-465a-82e5-ddc791fa7d66 0078-0423 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Novartis Pharmaceuticals Corporation VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0078-0424_eee37f88-ec6a-4c30-b8aa-e2c71f93088c 0078-0424 HUMAN PRESCRIPTION DRUG Ritalin LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20020605 NDA NDA021284 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0425_d84efbd9-c39a-3c0a-5918-2ed77f5cf4fb 0078-0425 HUMAN OTC DRUG GenTeal Moderate to Severe hypromelloses and carboxymethylcellulose sodium GEL OPHTHALMIC 20090914 OTC MONOGRAPH FINAL part349 Novartis Pharmaceutical Corporation HYPROMELLOSES; CARBOXYMETHYLCELLULOSE SODIUM 3; 2.5 mg/mL; mg/mL N 20181231 0078-0429_6e8fbf40-9e2b-f93c-71b9-9f7b1fc36429 0078-0429 HUMAN OTC DRUG GenTeal Severe HYPROMELLOSE GEL OPHTHALMIC 20090914 OTC MONOGRAPH FINAL part349 Novartis Pharmaceuticals Corporation HYPROMELLOSE 2910 (4000 MPA.S) .003 g/g N 20181231 0078-0430_bbe65071-7264-44fc-a105-b0c371493d39 0078-0430 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0431_bbe65071-7264-44fc-a105-b0c371493d39 0078-0431 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0432_bbe65071-7264-44fc-a105-b0c371493d39 0078-0432 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0433_bbe65071-7264-44fc-a105-b0c371493d39 0078-0433 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0434_bbe65071-7264-44fc-a105-b0c371493d39 0078-0434 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0435_11574d9e-8384-4121-b7f4-e25cf0e31ecd 0078-0435 HUMAN PRESCRIPTION DRUG Reclast zoledronic acid INJECTION, SOLUTION INTRAVENOUS 20070401 NDA NDA021817 Novartis Pharmaceuticals Corporation ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0078-0438_22044114-64ab-4d37-92a8-d2086d77cc1b 0078-0438 HUMAN PRESCRIPTION DRUG Gleevec imatinib mesylate TABLET ORAL 20010515 NDA NDA021588 Novartis Pharmaceuticals Corporation IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 0078-0439_ee90375c-6c6d-4afe-9cef-c61bd8f64301 0078-0439 HUMAN PRESCRIPTION DRUG Ritalin methylphenidate hydrochloride TABLET ORAL 19551231 NDA NDA010187 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0440_ee90375c-6c6d-4afe-9cef-c61bd8f64301 0078-0440 HUMAN PRESCRIPTION DRUG Ritalin methylphenidate hydrochloride TABLET ORAL 19551231 NDA NDA010187 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0441_ee90375c-6c6d-4afe-9cef-c61bd8f64301 0078-0441 HUMAN PRESCRIPTION DRUG Ritalin methylphenidate hydrochloride TABLET ORAL 19551231 NDA NDA010187 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0456_81e7e1a2-6b2f-4c03-90f4-ba52d40ea014 0078-0456 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine TABLET, FILM COATED ORAL 20000130 NDA NDA021014 Novartis Pharmaceuticals Corporation OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0078-0457_81e7e1a2-6b2f-4c03-90f4-ba52d40ea014 0078-0457 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine TABLET, FILM COATED ORAL 20000130 NDA NDA021014 Novartis Pharmaceuticals Corporation OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0078-0467_88530c90-9af3-42ba-8029-2f248a1c77ab 0078-0467 HUMAN PRESCRIPTION DRUG Desferal deferoxamine mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19680402 NDA NDA016267 Novartis Pharmaceuticals Corporation DEFEROXAMINE MESYLATE 500 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] N 20181231 0078-0468_77a5d82e-577e-4961-bc92-3adb52509b3c 0078-0468 HUMAN PRESCRIPTION DRUG Exjade deferasirox TABLET, FOR SUSPENSION ORAL 20051130 NDA NDA021882 Novartis Pharmaceuticals Corporation DEFERASIROX 125 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] N 20181231 0078-0469_77a5d82e-577e-4961-bc92-3adb52509b3c 0078-0469 HUMAN PRESCRIPTION DRUG Exjade deferasirox TABLET, FOR SUSPENSION ORAL 20051130 NDA NDA021882 Novartis Pharmaceuticals Corporation DEFERASIROX 250 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] N 20181231 0078-0470_77a5d82e-577e-4961-bc92-3adb52509b3c 0078-0470 HUMAN PRESCRIPTION DRUG Exjade deferasirox TABLET, FOR SUSPENSION ORAL 20051130 NDA NDA021882 Novartis Pharmaceuticals Corporation DEFERASIROX 500 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] N 20181231 0078-0471_77b3385c-4230-421c-9736-4d0835d12dea 0078-0471 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20060428 NDA NDA020818 Novartis Pharmaceuticals Corporation VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0078-0472_77b3385c-4230-421c-9736-4d0835d12dea 0078-0472 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20060428 NDA NDA020818 Novartis Pharmaceuticals Corporation VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0078-0473_56bd8893-b8d9-30c7-2722-e53d8d7903b1 0078-0473 HUMAN OTC DRUG GenTeal Night-time PM white petrolatum OINTMENT OPHTHALMIC 20091214 OTC MONOGRAPH FINAL part349 Novartis Pharmaceutical Corporation MINERAL OIL; PETROLATUM .15; .85 g/g; g/g N 20181231 0078-0478_6c5976d5-702b-25d9-18a2-edeffd8df30c 0078-0478 HUMAN PRESCRIPTION DRUG VOLTAREN diclofenac sodium SOLUTION OPHTHALMIC 19910328 NDA NDA020037 Novartis Pharmaceutical Corporation DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 0078-0485_225b07c4-ee87-4a87-b79f-43608584f32a 0078-0485 HUMAN PRESCRIPTION DRUG Tekturna aliskiren hemifumarate TABLET, FILM COATED ORAL 20070305 20180531 NDA NDA021985 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE 150 mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA] N 20181231 0078-0486_225b07c4-ee87-4a87-b79f-43608584f32a 0078-0486 HUMAN PRESCRIPTION DRUG Tekturna aliskiren hemifumarate TABLET, FILM COATED ORAL 20070305 20180531 NDA NDA021985 Novartis Pharmaceuticals Corporation ALISKIREN HEMIFUMARATE 300 mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA] N 20181231 0078-0488_33fbb912-df47-4ddc-8d8f-e5fbd51939f8 0078-0488 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20070620 NDA NDA021990 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0078-0489_33fbb912-df47-4ddc-8d8f-e5fbd51939f8 0078-0489 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20070620 NDA NDA021990 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0078-0490_33fbb912-df47-4ddc-8d8f-e5fbd51939f8 0078-0490 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20070620 NDA NDA021990 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0078-0491_33fbb912-df47-4ddc-8d8f-e5fbd51939f8 0078-0491 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20070620 NDA NDA021990 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0078-0493_bbe65071-7264-44fc-a105-b0c371493d39 0078-0493 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0494_77c22bc4-d60e-4ff1-a572-22d871717c19 0078-0494 HUMAN PRESCRIPTION DRUG TOBI Tobramycin SOLUTION ORAL 19971222 NDA NDA050753 Novartis Pharmaceuticals Corporation TOBRAMYCIN 300 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0078-0499_7757c044-1bce-486f-b8c2-11a5acf43822 0078-0499 HUMAN PRESCRIPTION DRUG Lamisil terbinafine hydrochloride GRANULE ORAL 20070928 NDA NDA022071 Novartis Pharmaceuticals Corporation TERBINAFINE HYDROCHLORIDE 125 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 0078-0500_7757c044-1bce-486f-b8c2-11a5acf43822 0078-0500 HUMAN PRESCRIPTION DRUG Lamisil terbinafine hydrochloride GRANULE ORAL 20070928 NDA NDA022071 Novartis Pharmaceuticals Corporation TERBINAFINE HYDROCHLORIDE 187.5 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 0078-0501_99e21fca-01c4-4947-86ab-e6aea6b24f2c 0078-0501 HUMAN PRESCRIPTION DRUG Exelon rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20070706 NDA NDA022083 Novartis Pharmaceuticals Corporation RIVASTIGMINE 4.6 mg/24h Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0078-0502_99e21fca-01c4-4947-86ab-e6aea6b24f2c 0078-0502 HUMAN PRESCRIPTION DRUG Exelon rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20070706 NDA NDA022083 Novartis Pharmaceuticals Corporation RIVASTIGMINE 9.5 mg/24h Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0078-0503_99e21fca-01c4-4947-86ab-e6aea6b24f2c 0078-0503 HUMAN PRESCRIPTION DRUG Exelon rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20070706 NDA NDA022083 Novartis Pharmaceuticals Corporation RIVASTIGMINE 13.3 mg/24h Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0078-0508_4446c11a-989f-412e-ba3d-a6c524a6f3d4 0078-0508 HUMAN PRESCRIPTION DRUG Tegretol carbamazepine SUSPENSION ORAL 19871218 NDA NDA018927 Novartis Pharmaceuticals Corporation CARBAMAZEPINE 100 mg/5mL Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0078-0509_4446c11a-989f-412e-ba3d-a6c524a6f3d4 0078-0509 HUMAN PRESCRIPTION DRUG Tegretol carbamazepine TABLET ORAL 19680311 NDA NDA016608 Novartis Pharmaceuticals Corporation CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0078-0510_4446c11a-989f-412e-ba3d-a6c524a6f3d4 0078-0510 HUMAN PRESCRIPTION DRUG Tegretol XR carbamazepine TABLET, EXTENDED RELEASE ORAL 19960325 NDA NDA020234 Novartis Pharmaceuticals Corporation CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0078-0511_4446c11a-989f-412e-ba3d-a6c524a6f3d4 0078-0511 HUMAN PRESCRIPTION DRUG Tegretol XR carbamazepine TABLET, EXTENDED RELEASE ORAL 19960325 NDA NDA020234 Novartis Pharmaceuticals Corporation CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0078-0512_4446c11a-989f-412e-ba3d-a6c524a6f3d4 0078-0512 HUMAN PRESCRIPTION DRUG Tegretol XR carbamazepine TABLET, EXTENDED RELEASE ORAL 19960325 NDA NDA020234 Novartis Pharmaceuticals Corporation CARBAMAZEPINE 400 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0078-0517_10686b14-888b-f19a-cbc0-8f9b59264689 0078-0517 HUMAN OTC DRUG GenTeal Mild hypromellose LIQUID OPHTHALMIC 20090914 OTC MONOGRAPH FINAL part349 Novartis Pharmaceutical Corporation HYPROMELLOSE 2910 (4000 MPA.S) .002 L/L N 20181231 0078-0518_f9a7c50d-feb8-375d-cc86-1a779df24eea 0078-0518 HUMAN OTC DRUG GenTeal Mild to Moderate hypromellose LIQUID OPHTHALMIC 20090914 OTC MONOGRAPH FINAL part349 Novartis Pharmaceutical Corporation HYPROMELLOSE 2910 (4000 MPA.S) .003 L/L N 20181231 0078-0519_1f11fbef-9c86-c646-a1f9-cdff7fea102f 0078-0519 HUMAN OTC DRUG HypoTears polyvinyl alcohol and polyehtylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20050701 OTC MONOGRAPH FINAL part349 Novartis Pharmaceutical Corporation POLYVINYL ALCOHOL; POLYETHYLENE GLYCOL 400 10; 10 mg/mL; mg/mL E 20171231 0078-0526_223a210b-8e09-4694-a3a9-c403ef46ea84 0078-0526 HUMAN PRESCRIPTION DRUG Tasigna nilotinib CAPSULE ORAL 20071029 NDA NDA022068 Novartis Pharmaceuticals Corporation NILOTINIB 200 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0078-0527_5ae03a7a-7282-4998-b111-2d81718fc058 0078-0527 HUMAN PRESCRIPTION DRUG Stalevo carbidopa, levodopa, and entacapone TABLET, FILM COATED ORAL 20070802 NDA NDA021485 Novartis Pharmaceuticals Corporation CARBIDOPA; LEVODOPA; ENTACAPONE 50; 200; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0078-0538_77b54cf7-6c2f-4b87-a1db-94db34c17363 0078-0538 HUMAN PRESCRIPTION DRUG Tyzeka telbivudine TABLET, FILM COATED ORAL 20061025 20180228 NDA NDA022011 Novartis Pharmaceuticals Corporation TELBIVUDINE 600 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0078-0544_5ae03a7a-7282-4998-b111-2d81718fc058 0078-0544 HUMAN PRESCRIPTION DRUG Stalevo carbidopa, levodopa, and entacapone TABLET, FILM COATED ORAL 20080926 NDA NDA021485 Novartis Pharmaceuticals Corporation CARBIDOPA; LEVODOPA; ENTACAPONE 18.75; 75; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0078-0545_5ae03a7a-7282-4998-b111-2d81718fc058 0078-0545 HUMAN PRESCRIPTION DRUG Stalevo carbidopa, levodopa, and entacapone TABLET, FILM COATED ORAL 20080926 NDA NDA021485 Novartis Pharmaceuticals Corporation CARBIDOPA; LEVODOPA; ENTACAPONE 31.25; 125; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0078-0559_ccf620d2-43b0-4631-9a2a-3cb07693c5b6 0078-0559 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20090404 NDA NDA022314 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0078-0560_ccf620d2-43b0-4631-9a2a-3cb07693c5b6 0078-0560 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20090404 NDA NDA022314 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0078-0561_ccf620d2-43b0-4631-9a2a-3cb07693c5b6 0078-0561 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20090404 NDA NDA022314 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0078-0562_ccf620d2-43b0-4631-9a2a-3cb07693c5b6 0078-0562 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20090404 NDA NDA022314 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0078-0563_ccf620d2-43b0-4631-9a2a-3cb07693c5b6 0078-0563 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20090404 NDA NDA022314 Novartis Pharmaceuticals Corporation AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 320; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0078-0566_66914328-2ec0-49c4-800b-51a9ddbcc386 0078-0566 HUMAN PRESCRIPTION DRUG Afinitor everolimus TABLET ORAL 20090331 NDA NDA022334 Novartis Pharmaceuticals Corporation EVEROLIMUS 5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE] N 20181231 0078-0567_66914328-2ec0-49c4-800b-51a9ddbcc386 0078-0567 HUMAN PRESCRIPTION DRUG Afinitor everolimus TABLET ORAL 20090331 NDA NDA022334 Novartis Pharmaceuticals Corporation EVEROLIMUS 10 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE] N 20181231 0078-0568_a1c22824-c324-451d-af40-85e53e9460b1 0078-0568 HUMAN PRESCRIPTION DRUG COARTEM artemether and lumefantrine TABLET ORAL 20090407 NDA NDA022268 Novartis Pharmaceuticals Corporation ARTEMETHER; LUMEFANTRINE 20; 120 mg/1; mg/1 Antimalarial [EPC],Antimalarial [EPC] N 20191231 0078-0569_77bcd313-1b72-4f00-882a-559a002136bf 0078-0569 HUMAN PRESCRIPTION DRUG EXTAVIA Interferon beta-1b KIT 20090814 BLA BLA125290 Novartis Pharmaceuticals Corporation N 20181231 0078-0582_bb044a74-7007-446d-931b-0238d62db2fc 0078-0582 HUMAN PRESCRIPTION DRUG Ilaris canakinumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20090618 BLA BLA125319 Novartis Pharmaceuticals Corporation CANAKINUMAB 150 mg/mL N 20181231 0078-0590_993aa2f3-5d6f-4816-9315-5904cbc16757 0078-0590 HUMAN PRESCRIPTION DRUG Zometa zoledronic acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20010820 NDA NDA021223 Novartis Pharmaceuticals Corporation ZOLEDRONIC ACID 4 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0078-0592_223a210b-8e09-4694-a3a9-c403ef46ea84 0078-0592 HUMAN PRESCRIPTION DRUG Tasigna nilotinib CAPSULE ORAL 20071029 NDA NDA022068 Novartis Pharmaceuticals Corporation NILOTINIB 150 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0078-0594_66914328-2ec0-49c4-800b-51a9ddbcc386 0078-0594 HUMAN PRESCRIPTION DRUG Afinitor everolimus TABLET ORAL 20100709 NDA NDA022334 Novartis Pharmaceuticals Corporation EVEROLIMUS 2.5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE] N 20181231 0078-0607_6bbacbcd-4e00-4176-a8bc-c49e50d198fe 0078-0607 HUMAN PRESCRIPTION DRUG Gilenya Fingolimod hcl CAPSULE ORAL 20100921 NDA NDA022527 Novartis Pharmaceuticals Corporation FINGOLIMOD HYDROCHLORIDE .5 mg/1 Sphingosine 1-Phosphate Receptor Modulators [MoA],Sphingosine 1-phosphate Receptor Modulator [EPC] N 20181231 0078-0608_bbe65071-7264-44fc-a105-b0c371493d39 0078-0608 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 25 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0609_bbe65071-7264-44fc-a105-b0c371493d39 0078-0609 HUMAN PRESCRIPTION DRUG Focalin XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050531 NDA NDA021802 Novartis Pharmaceuticals Corporation DEXMETHYLPHENIDATE HYDROCHLORIDE 35 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0619_6622d6db-adf4-4e36-b243-c23f3d4ba08e 0078-0619 HUMAN PRESCRIPTION DRUG Arcapta Neohaler Indacaterol maleate CAPSULE ORAL; RESPIRATORY (INHALATION) 20110701 20180831 NDA NDA022383 Novartis Pharmaceuticals Corporation INDACATEROL MALEATE 75 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0078-0620_66914328-2ec0-49c4-800b-51a9ddbcc386 0078-0620 HUMAN PRESCRIPTION DRUG Afinitor everolimus TABLET ORAL 20110729 NDA NDA022334 Novartis Pharmaceuticals Corporation EVEROLIMUS 7.5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE] N 20181231 0078-0626_66914328-2ec0-49c4-800b-51a9ddbcc386 0078-0626 HUMAN PRESCRIPTION DRUG Afinitor Disperz everolimus TABLET, FOR SUSPENSION ORAL 20120829 NDA NDA203985 Novartis Pharmaceuticals Corporation EVEROLIMUS 2 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE] N 20181231 0078-0627_66914328-2ec0-49c4-800b-51a9ddbcc386 0078-0627 HUMAN PRESCRIPTION DRUG Afinitor Disperz everolimus TABLET, FOR SUSPENSION ORAL 20120829 NDA NDA203985 Novartis Pharmaceuticals Corporation EVEROLIMUS 3 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE] N 20181231 0078-0628_66914328-2ec0-49c4-800b-51a9ddbcc386 0078-0628 HUMAN PRESCRIPTION DRUG Afinitor Disperz everolimus TABLET, FOR SUSPENSION ORAL 20120829 NDA NDA203985 Novartis Pharmaceuticals Corporation EVEROLIMUS 5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE] N 20181231 0078-0630_77a25aa9-d445-4568-a3cb-9b9cd9974dee 0078-0630 HUMAN PRESCRIPTION DRUG TOBI Podhaler Tobramycin CAPSULE ORAL; RESPIRATORY (INHALATION) 20130322 NDA NDA201688 Novartis Pharmaceuticals Corporation TOBRAMYCIN 28 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0078-0633_dd994d84-aaae-413e-9201-2ec5e7d1fcbd 0078-0633 HUMAN PRESCRIPTION DRUG Signifor pasireotide INJECTION SUBCUTANEOUS 20121214 NDA NDA200677 Novartis Pharmaceuticals Corporation PASIREOTIDE .3 mg/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0078-0634_dd994d84-aaae-413e-9201-2ec5e7d1fcbd 0078-0634 HUMAN PRESCRIPTION DRUG Signifor pasireotide INJECTION SUBCUTANEOUS 20121214 NDA NDA200677 Novartis Pharmaceuticals Corporation PASIREOTIDE .6 mg/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0078-0635_dd994d84-aaae-413e-9201-2ec5e7d1fcbd 0078-0635 HUMAN PRESCRIPTION DRUG Signifor pasireotide INJECTION SUBCUTANEOUS 20121214 NDA NDA200677 Novartis Pharmaceuticals Corporation PASIREOTIDE .9 mg/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0078-0639_90dbd0a5-0694-44cc-90d4-4cf3a59a5510 0078-0639 HUMAN PRESCRIPTION DRUG COSENTYX secukinumab INJECTION SUBCUTANEOUS 20150121 BLA BLA125504 Novartis Pharmaceuticals Corporation SECUKINUMAB 150 mg/mL Interleukin-17A Antagonist [EPC],Interleukin-17A Antagonists [MoA] N 20191231 0078-0640_7f32eb50-3a96-49b8-918d-3a3e0be75f86 0078-0640 HUMAN PRESCRIPTION DRUG ZYKADIA ceritinib CAPSULE ORAL 20140429 NDA NDA205755 Novartis Pharmaceuticals Corporation CERITINIB 150 mg/1 Kinase Inhibitor [EPC],Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 0078-0641_331e0de3-3f24-4d65-937a-2955a90ea9ab 0078-0641 HUMAN PRESCRIPTION DRUG Signifor LAR pasireotide KIT 20141215 NDA NDA203255 Novartis Pharmaceuticals Corporation N 20181231 0078-0642_331e0de3-3f24-4d65-937a-2955a90ea9ab 0078-0642 HUMAN PRESCRIPTION DRUG Signifor LAR pasireotide KIT 20141215 NDA NDA203255 Novartis Pharmaceuticals Corporation N 20181231 0078-0643_331e0de3-3f24-4d65-937a-2955a90ea9ab 0078-0643 HUMAN PRESCRIPTION DRUG Signifor LAR pasireotide KIT 20141215 NDA NDA203255 Novartis Pharmaceuticals Corporation N 20181231 0078-0646_4421b6a4-11f4-48f5-9068-5336fb43d65b 0078-0646 HUMAN PRESCRIPTION DRUG Sandostatin LAR Depot octreotide acetate KIT 20150201 NDA NDA021008 Novartis Pharmaceuticals Corporation N 20181231 0078-0647_4421b6a4-11f4-48f5-9068-5336fb43d65b 0078-0647 HUMAN PRESCRIPTION DRUG Sandostatin LAR Depot octreotide acetate KIT 20150201 NDA NDA021008 Novartis Pharmaceuticals Corporation N 20181231 0078-0648_4421b6a4-11f4-48f5-9068-5336fb43d65b 0078-0648 HUMAN PRESCRIPTION DRUG Sandostatin LAR Depot octreotide acetate KIT 20150201 NDA NDA021008 Novartis Pharmaceuticals Corporation N 20181231 0078-0649_22044114-64ab-4d37-92a8-d2086d77cc1b 0078-0649 HUMAN PRESCRIPTION DRUG Gleevec imatinib mesylate TABLET ORAL 20141223 NDA NDA021588 Novartis Pharmaceuticals Corporation IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 0078-0650_551444be-7168-4782-8219-c790b8f0bbde 0078-0650 HUMAN PRESCRIPTION DRUG FARYDAK panobinostat CAPSULE ORAL 20150223 NDA NDA205353 Novartis Pharmaceuticals Corporation PANOBINOSTAT LACTATE 10 mg/1 Histone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0078-0651_551444be-7168-4782-8219-c790b8f0bbde 0078-0651 HUMAN PRESCRIPTION DRUG FARYDAK panobinostat CAPSULE ORAL 20150223 NDA NDA205353 Novartis Pharmaceuticals Corporation PANOBINOSTAT LACTATE 15 mg/1 Histone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0078-0652_551444be-7168-4782-8219-c790b8f0bbde 0078-0652 HUMAN PRESCRIPTION DRUG FARYDAK panobinostat CAPSULE ORAL 20150223 NDA NDA205353 Novartis Pharmaceuticals Corporation PANOBINOSTAT LACTATE 20 mg/1 Histone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0078-0654_ff2ffca0-5fb7-422c-b2bf-c8214c887007 0078-0654 HUMAN PRESCRIPTION DRUG Jadenu deferasirox TABLET, FILM COATED ORAL 20150330 NDA NDA206910 Novartis Pharmaceuticals Corporation DEFERASIROX 90 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] N 20181231 0078-0655_ff2ffca0-5fb7-422c-b2bf-c8214c887007 0078-0655 HUMAN PRESCRIPTION DRUG Jadenu deferasirox TABLET, FILM COATED ORAL 20150330 NDA NDA206910 Novartis Pharmaceuticals Corporation DEFERASIROX 180 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] N 20181231 0078-0656_ff2ffca0-5fb7-422c-b2bf-c8214c887007 0078-0656 HUMAN PRESCRIPTION DRUG Jadenu deferasirox TABLET, FILM COATED ORAL 20150330 NDA NDA206910 Novartis Pharmaceuticals Corporation DEFERASIROX 360 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] N 20181231 0078-0658_eee37f88-ec6a-4c30-b8aa-e2c71f93088c 0078-0658 HUMAN PRESCRIPTION DRUG Ritalin LA methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150201 NDA NDA021284 Novartis Pharmaceuticals Corporation METHYLPHENIDATE HYDROCHLORIDE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0078-0659_fe25b914-9d1e-4b86-bab5-947c78a30fcb 0078-0659 HUMAN PRESCRIPTION DRUG ENTRESTO Sacubitril and Valsartan TABLET, FILM COATED ORAL 20150707 NDA NDA207620 Novartis Pharmaceuticals Corporation SACUBITRIL; VALSARTAN 24; 26 mg/1; mg/1 Neprilysin Inhibitor [EPC],Neprilysin Inhibitors [MoA],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0078-0662_77c83e67-16ea-4b70-bfe8-e2a03926e278 0078-0662 HUMAN PRESCRIPTION DRUG SEEBRI NEOHALER glycopyrrolate CAPSULE RESPIRATORY (INHALATION) 20151029 20190630 NDA NDA207923 Novartis Pharmaceuticals Corporation GLYCOPYRROLATE 15.6 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 0078-0664_77de1b47-3665-4fb2-b7a5-31dcbcd63622 0078-0664 HUMAN PRESCRIPTION DRUG UTIBRON NEOHALER indacaterol and glycopyrrolate CAPSULE RESPIRATORY (INHALATION) 20151029 20190630 NDA NDA207930 Novartis Pharmaceuticals Corporation INDACATEROL MALEATE; GLYCOPYRROLATE 27.5; 15.6 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 0078-0666_99882454-9825-4ac1-b3fe-a0b09a5cd8de 0078-0666 HUMAN PRESCRIPTION DRUG Mekinist trametinib TABLET, FILM COATED ORAL 20160317 NDA NDA204114 Novartis Pharmaceuticals Corporation TRAMETINIB DIMETHYL SULFOXIDE .5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 0078-0668_99882454-9825-4ac1-b3fe-a0b09a5cd8de 0078-0668 HUMAN PRESCRIPTION DRUG Mekinist trametinib TABLET, FILM COATED ORAL 20160317 NDA NDA204114 Novartis Pharmaceuticals Corporation TRAMETINIB DIMETHYL SULFOXIDE 2 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 0078-0669_330de426-198d-4db0-adee-073923a9f072 0078-0669 HUMAN PRESCRIPTION DRUG ARZERRA ofatumumab INJECTION, SOLUTION INTRAVENOUS 20160201 BLA BLA125326 Novartis Pharmaceuticals Corporation OFATUMUMAB 20 mg/mL CD20-directed Cytolytic Antibody [EPC],CD20-directed Antibody Interactions [MoA] N 20181231 0078-0670_33e1719c-5019-46c8-8b30-ce1beed97c30 0078-0670 HUMAN PRESCRIPTION DRUG VOTRIENT pazopanib hydrochloride TABLET, FILM COATED ORAL 20160712 NDA NDA022465 Novartis Pharmaceuticals Corporation PAZOPANIB HYDROCHLORIDE 200 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 0078-0671_222a3dc9-99ba-4154-8606-a71665546a3f 0078-0671 HUMAN PRESCRIPTION DRUG TYKERB lapatinib TABLET ORAL 20160803 NDA NDA022059 Novartis Pharmaceuticals Corporation LAPATINIB DITOSYLATE 250 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 0078-0672_221854df-9a47-444a-98c8-2f77c370df1c 0078-0672 HUMAN PRESCRIPTION DRUG HYCAMTIN topotecan CAPSULE ORAL 20170707 NDA NDA020981 Novartis Pharmaceuticals Corporation TOPOTECAN HYDROCHLORIDE .25 mg/1 Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0078-0673_221854df-9a47-444a-98c8-2f77c370df1c 0078-0673 HUMAN PRESCRIPTION DRUG HYCAMTIN topotecan CAPSULE ORAL 20170224 NDA NDA020981 Novartis Pharmaceuticals Corporation TOPOTECAN HYDROCHLORIDE 1 mg/1 Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0078-0674_112d98de-93fa-47d9-be0e-86e26671b812 0078-0674 HUMAN PRESCRIPTION DRUG HYCAMTIN topotecan hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20161221 NDA NDA020671 Novartis Pharmaceuticals Corporation TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0078-0676_ddd65234-fdd2-4495-8192-e57f0016226b 0078-0676 HUMAN PRESCRIPTION DRUG ZOFRAN ondansetron hydrochloride TABLET, FILM COATED ORAL 20171212 NDA NDA020103 Novartis Pharmaceuticals Corporation ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0078-0679_ddd65234-fdd2-4495-8192-e57f0016226b 0078-0679 HUMAN PRESCRIPTION DRUG ZOFRAN ODT ondansetron hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20170823 NDA NDA020781 Novartis Pharmaceuticals Corporation ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0078-0680_ddd65234-fdd2-4495-8192-e57f0016226b 0078-0680 HUMAN PRESCRIPTION DRUG ZOFRAN ODT ondansetron hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20170823 NDA NDA020781 Novartis Pharmaceuticals Corporation ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0078-0681_cab88fd1-802f-4602-8c6f-f4d20b537662 0078-0681 HUMAN PRESCRIPTION DRUG Tafinlar dabrafenib CAPSULE ORAL 20160401 NDA NDA202806 Novartis Pharmaceuticals Corporation DABRAFENIB MESYLATE 75 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Organic Anion Transporter 1 Inhibitors [MoA],Organic Anion Transporter 3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 0078-0682_cab88fd1-802f-4602-8c6f-f4d20b537662 0078-0682 HUMAN PRESCRIPTION DRUG Tafinlar dabrafenib CAPSULE ORAL 20160412 NDA NDA202806 Novartis Pharmaceuticals Corporation DABRAFENIB MESYLATE 50 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Organic Anion Transporter 1 Inhibitors [MoA],Organic Anion Transporter 3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 0078-0683_aa41d999-2473-40e9-842e-c8b98ecb27c2 0078-0683 HUMAN PRESCRIPTION DRUG Arranon nelarabine INJECTION INTRAVENOUS 20161005 NDA NDA021877 Novartis Pharmaceuticals Corporation NELARABINE 5 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0078-0684_8811cdab-d371-460e-9fb0-5b2968405a9b 0078-0684 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20160822 NDA NDA022291 Novartis Pharmaceuticals Corporation ELTROMBOPAG OLAMINE 12.5 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA] N 20181231 0078-0685_8811cdab-d371-460e-9fb0-5b2968405a9b 0078-0685 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20160524 NDA NDA022291 Novartis Pharmaceuticals Corporation ELTROMBOPAG OLAMINE 25 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA] N 20181231 0078-0686_8811cdab-d371-460e-9fb0-5b2968405a9b 0078-0686 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20160407 NDA NDA022291 Novartis Pharmaceuticals Corporation ELTROMBOPAG OLAMINE 50 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA] N 20181231 0078-0687_8811cdab-d371-460e-9fb0-5b2968405a9b 0078-0687 HUMAN PRESCRIPTION DRUG PROMACTA eltrombopag olamine TABLET, FILM COATED ORAL 20160401 NDA NDA022291 Novartis Pharmaceuticals Corporation ELTROMBOPAG OLAMINE 75 mg/1 Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA] N 20181231 0078-0690_330de426-198d-4db0-adee-073923a9f072 0078-0690 HUMAN PRESCRIPTION DRUG ARZERRA ofatumumab INJECTION, SOLUTION INTRAVENOUS 20160201 BLA BLA125326 Novartis Pharmaceuticals Corporation OFATUMUMAB 20 mg/mL CD20-directed Cytolytic Antibody [EPC],CD20-directed Antibody Interactions [MoA] N 20181231 0078-0696_fe25b914-9d1e-4b86-bab5-947c78a30fcb 0078-0696 HUMAN PRESCRIPTION DRUG ENTRESTO Sacubitril and Valsartan TABLET, FILM COATED ORAL 20150707 NDA NDA207620 Novartis Pharmaceuticals Corporation SACUBITRIL; VALSARTAN 97; 103 mg/1; mg/1 Neprilysin Inhibitor [EPC],Neprilysin Inhibitors [MoA],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0078-0698_11fa3fc9-6776-49a6-b1c1-653f627c3e58 0078-0698 HUMAN PRESCRIPTION DRUG RYDAPT RYDAPT CAPSULE, LIQUID FILLED ORAL 20170428 NDA NDA207997 Novartis Pharmaceuticals Corporation MIDOSTAURIN 25 mg/1 Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA] N 20181231 0078-0713_ff2ffca0-5fb7-422c-b2bf-c8214c887007 0078-0713 HUMAN PRESCRIPTION DRUG Jadenu deferasirox GRANULE ORAL 20170518 NDA NDA207968 Novartis Pharmaceuticals Corporation DEFERASIROX 180 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] N 20181231 0078-0720_ff2ffca0-5fb7-422c-b2bf-c8214c887007 0078-0720 HUMAN PRESCRIPTION DRUG Jadenu deferasirox GRANULE ORAL 20170518 NDA NDA207968 Novartis Pharmaceuticals Corporation DEFERASIROX 360 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] N 20181231 0078-0727_ff2ffca0-5fb7-422c-b2bf-c8214c887007 0078-0727 HUMAN PRESCRIPTION DRUG Jadenu deferasirox GRANULE ORAL 20170518 NDA NDA207968 Novartis Pharmaceuticals Corporation DEFERASIROX 90 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] N 20181231 0078-0734_bb044a74-7007-446d-931b-0238d62db2fc 0078-0734 HUMAN PRESCRIPTION DRUG Ilaris canakinumab INJECTION, SOLUTION SUBCUTANEOUS 20161222 BLA BLA125319 Novartis Pharmaceuticals Corporation CANAKINUMAB 150 mg/mL N 20181231 0078-0777_fe25b914-9d1e-4b86-bab5-947c78a30fcb 0078-0777 HUMAN PRESCRIPTION DRUG ENTRESTO Sacubitril and Valsartan TABLET, FILM COATED ORAL 20150707 NDA NDA207620 Novartis Pharmaceuticals Corporation SACUBITRIL; VALSARTAN 49; 51 mg/1; mg/1 Neprilysin Inhibitor [EPC],Neprilysin Inhibitors [MoA],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0078-0811_4421b6a4-11f4-48f5-9068-5336fb43d65b 0078-0811 HUMAN PRESCRIPTION DRUG Sandostatin LAR Depot octreotide acetate KIT 20160722 NDA NDA021008 Novartis Pharmaceuticals Corporation N 20181231 0078-0818_4421b6a4-11f4-48f5-9068-5336fb43d65b 0078-0818 HUMAN PRESCRIPTION DRUG Sandostatin LAR Depot octreotide acetate KIT 20160722 NDA NDA021008 Novartis Pharmaceuticals Corporation N 20181231 0078-0825_4421b6a4-11f4-48f5-9068-5336fb43d65b 0078-0825 HUMAN PRESCRIPTION DRUG Sandostatin LAR Depot octreotide acetate KIT 20160722 NDA NDA021008 Novartis Pharmaceuticals Corporation N 20181231 0078-0846_22dc1c28-0cf5-4290-b499-eb5391a232c2 0078-0846 CELLULAR THERAPY KYMRIAH tisagenlecleucel INJECTION, SUSPENSION INTRAVENOUS 20170830 BLA BLA125646 Novartis Pharmaceuticals Corporation TISAGENLECLEUCEL 2000000 1/1 N 20181231 0078-0860_11364b70-4e7c-49de-8e2c-17c35a22e36f 0078-0860 HUMAN PRESCRIPTION DRUG KISQALI ribociclib TABLET, FILM COATED ORAL 20170313 NDA NDA209092 Novartis Pharmaceuticals Corporation RIBOCICLIB 200 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 0078-0867_11364b70-4e7c-49de-8e2c-17c35a22e36f 0078-0867 HUMAN PRESCRIPTION DRUG KISQALI ribociclib TABLET, FILM COATED ORAL 20170313 NDA NDA209092 Novartis Pharmaceuticals Corporation RIBOCICLIB 200 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 0078-0874_11364b70-4e7c-49de-8e2c-17c35a22e36f 0078-0874 HUMAN PRESCRIPTION DRUG KISQALI ribociclib TABLET, FILM COATED ORAL 20170313 NDA NDA209092 Novartis Pharmaceuticals Corporation RIBOCICLIB 200 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 0078-0909_bbb67312-e5e6-4537-a95c-59c324ab549f 0078-0909 HUMAN PRESCRIPTION DRUG KISQALI FEMARA CO-PACK letrozole and ribociclib KIT 20170504 NDA NDA209935 Novartis Pharmaceuticals Corporation N 20181231 0078-0916_bbb67312-e5e6-4537-a95c-59c324ab549f 0078-0916 HUMAN PRESCRIPTION DRUG KISQALI FEMARA CO-PACK letrozole and ribociclib KIT 20170504 NDA NDA209935 Novartis Pharmaceuticals Corporation N 20181231 0078-0923_bbb67312-e5e6-4537-a95c-59c324ab549f 0078-0923 HUMAN PRESCRIPTION DRUG KISQALI FEMARA CO-PACK letrozole and ribociclib KIT 20170504 NDA NDA209935 Novartis Pharmaceuticals Corporation N 20181231 0085-0370_b2e6718f-a8d7-48e1-96da-33e77d06a415 0085-0370 HUMAN PRESCRIPTION DRUG ELOCON mometasone furoate OINTMENT TOPICAL 19870430 NDA NDA019543 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-0492_66fe15cf-5f84-42da-8564-7df48782f28f 0085-0492 HUMAN PRESCRIPTION DRUG Guanidine hydrochloride Guanidine hydrochloride TABLET ORAL 19391002 NDA NDA001546 Merck Sharp & Dohme Corp. GUANIDINE HYDROCHLORIDE 125 mg/1 Acetylcholine Releasing Agent [EPC],Increased Acetylcholine Activity [PE] N 20191231 0085-0517_03c5bce2-d4c1-4f61-84f0-0afb17b5cb1e 0085-0517 HUMAN PRESCRIPTION DRUG DIPROLENE AF betamethasone dipropionate CREAM TOPICAL 19870427 NDA NDA019555 Merck Sharp & Dohme Corp. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-0566_fba8e08c-0dcb-42ad-b443-53983b429473 0085-0566 HUMAN PRESCRIPTION DRUG CELESTONE SOLUSPAN Betamethasone Acetate and Betamethasone Sodium Phosphate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 19650315 NDA NDA014602 Merck Sharp & Dohme Corp. BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-0575_8e6bd981-4dd5-4c93-ae26-aeed89e32ef6 0085-0575 HUMAN PRESCRIPTION DRUG DIPROLENE betamethasone dipropionate OINTMENT TOPICAL 19830727 NDA NDA018741 Merck Sharp & Dohme Corp. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-0819_a3925ec2-2c8e-4c48-b4dd-d7655f823173 0085-0819 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 19950404 NDA NDA020145 Merck Sharp & Dohme Corp. NITROGLYCERIN 160 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0085-0854_7ccdf37c-454b-4686-8075-fbe684e6415d 0085-0854 HUMAN PRESCRIPTION DRUG ELOCON Mometasone Furoate LOTION TOPICAL 19890330 NDA NDA019796 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-0924_15028e19-7a42-4ecd-ba47-5a21adc2359b 0085-0924 HUMAN PRESCRIPTION DRUG Lotrisone Clotrimazole and Betamethasone dipropionate CREAM TOPICAL 19840710 NDA NDA018827 Merck Sharp & Dohme Corp. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-0962_10ba8807-ee8d-467b-895d-4f6b9c4fd657 0085-0962 HUMAN PRESCRIPTION DRUG DIPROLENE betamethasone dipropionate LOTION TOPICAL 19880801 NDA NDA019716 Merck Sharp & Dohme Corp. BETAMETHASONE DIPROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0085-1132_7922b9a8-f984-49a8-b88e-fe84ac6964e8 0085-1132 HUMAN PRESCRIPTION DRUG Proventil HFA Albuterol Sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20011001 NDA NDA020503 Merck Sharp & Dohme Corp. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0085-1133_14fa9d3f-4a12-4259-b2b7-217f1d1c7328 0085-1133 HUMAN PRESCRIPTION DRUG INTRON A Interferon alfa-2b INJECTION, SOLUTION INTRALESIONAL; INTRAMUSCULAR; SUBCUTANEOUS 19860604 BLA BLA103132 Merck Sharp & Dohme Corp. INTERFERON ALFA-2B 19.2 ug/.5mL Interferon Alfa-2b [Chemical/Ingredient],Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] N 20181231 0085-1136_09400257-b29a-4eb6-972b-25b966979db5 0085-1136 HUMAN PRESCRIPTION DRUG Integrilin Eptifibatide INJECTION, SOLUTION INTRAVENOUS 20150123 NDA NDA020718 Merck Sharp & Dohme Corp. EPTIFIBATIDE .75 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0085-1136_0d4f321d-46bb-4789-a1a3-a6fbc08c61fa 0085-1136 HUMAN PRESCRIPTION DRUG Integrilin Eptifibatide INJECTION, SOLUTION INTRAVENOUS 19980518 NDA NDA020718 Merck Sharp & Dohme Corp. EPTIFIBATIDE .75 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0085-1136_6b08d39d-179d-4099-8af4-efe0caefd812 0085-1136 HUMAN PRESCRIPTION DRUG Integrilin Eptifibatide INJECTION, SOLUTION INTRAVENOUS 20140818 NDA NDA020718 Merck Sharp & Dohme Corp. EPTIFIBATIDE .75 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0085-1168_14fa9d3f-4a12-4259-b2b7-217f1d1c7328 0085-1168 HUMAN PRESCRIPTION DRUG INTRON A Interferon alfa-2b INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 19860604 BLA BLA103132 Merck Sharp & Dohme Corp. INTERFERON ALFA-2B 11.6 ug/.5mL Interferon Alfa-2b [Chemical/Ingredient],Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] N 20181231 0085-1177_09400257-b29a-4eb6-972b-25b966979db5 0085-1177 HUMAN PRESCRIPTION DRUG Integrilin Eptifibatide INJECTION, SOLUTION INTRAVENOUS 20150123 NDA NDA020718 Merck Sharp & Dohme Corp. EPTIFIBATIDE 2 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0085-1177_0d4f321d-46bb-4789-a1a3-a6fbc08c61fa 0085-1177 HUMAN PRESCRIPTION DRUG Integrilin Eptifibatide INJECTION, SOLUTION INTRAVENOUS 19980518 NDA NDA020718 Merck Sharp & Dohme Corp. EPTIFIBATIDE 2 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0085-1177_6b08d39d-179d-4099-8af4-efe0caefd812 0085-1177 HUMAN PRESCRIPTION DRUG Integrilin Eptifibatide INJECTION, SOLUTION INTRAVENOUS 20150123 NDA NDA020718 Merck Sharp & Dohme Corp. EPTIFIBATIDE 2 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0085-1194_a9e99485-26c9-4768-abee-f6629dd7092b 0085-1194 HUMAN PRESCRIPTION DRUG REBETOL ribavirin CAPSULE ORAL 19980603 NDA NDA020903 Merck Sharp & Dohme Corp. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 0085-1264_646926bf-b813-4b71-8f80-632d96e36f32 0085-1264 HUMAN PRESCRIPTION DRUG Clarinex Desloratadine TABLET, FILM COATED ORAL 20011221 NDA NDA021165 Merck Sharp & Dohme Corp. DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 0085-1288_52dfee8f-2477-4295-a1b2-4d5d25c457e9 0085-1288 HUMAN PRESCRIPTION DRUG NASONEX Mometasone furoate monohydrate SPRAY, METERED NASAL 19971001 NDA NDA020762 Merck Sharp & Dohme Corp. MOMETASONE FUROATE MONOHYDRATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-1297_4a46e598-5555-4800-826c-c9889ead6dd8 0085-1297 HUMAN PRESCRIPTION DRUG PEGINTRON Peginterferon alfa-2b INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20010119 BLA BLA103949 Merck Sharp & Dohme Corp. PEGINTERFERON ALFA-2B 120 ug/.5mL Interferon Alfa-2b [Chemical/Ingredient],Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] N 20181231 0085-1316_4a46e598-5555-4800-826c-c9889ead6dd8 0085-1316 HUMAN PRESCRIPTION DRUG PEGINTRON Peginterferon alfa-2b INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20010119 BLA BLA103949 Merck Sharp & Dohme Corp. PEGINTERFERON ALFA-2B 80 ug/.5mL Interferon Alfa-2b [Chemical/Ingredient],Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] N 20181231 0085-1318_a9e99485-26c9-4768-abee-f6629dd7092b 0085-1318 HUMAN PRESCRIPTION DRUG REBETOL ribavirin LIQUID ORAL 20030729 NDA NDA021546 Merck Sharp & Dohme Corp. RIBAVIRIN 40 mg/mL Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 0085-1322_92118276-975f-44d9-b9a1-b59aa96a577f 0085-1322 HUMAN PRESCRIPTION DRUG CLARINEX-D 12 HOUR desloratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE ORAL 20060201 NDA NDA021313 Merck Sharp & Dohme Corp. DESLORATADINE; PSEUDOEPHEDRINE SULFATE 2.5; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20191231 0085-1323_4a46e598-5555-4800-826c-c9889ead6dd8 0085-1323 HUMAN PRESCRIPTION DRUG PEGINTRON Peginterferon alfa-2b INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20010119 BLA BLA103949 Merck Sharp & Dohme Corp. PEGINTERFERON ALFA-2B 50 ug/.5mL Interferon Alfa-2b [Chemical/Ingredient],Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] N 20181231 0085-1328_c702df2e-4753-4763-9d05-c22a2cb390c6 0085-1328 HUMAN PRESCRIPTION DRUG NOXAFIL posaconazole SUSPENSION ORAL 20060915 NDA NDA022003 Merck Sharp & Dohme Corp. POSACONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0085-1334_646926bf-b813-4b71-8f80-632d96e36f32 0085-1334 HUMAN PRESCRIPTION DRUG Clarinex Desloratadine SOLUTION ORAL 20040901 NDA NDA021300 Merck Sharp & Dohme Corp. DESLORATADINE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 0085-1341_5ff4ad68-7890-49f2-837b-ac9a2d76ce4d 0085-1341 HUMAN PRESCRIPTION DRUG ASMANEX Mometasone Furoate INHALANT RESPIRATORY (INHALATION) 20050330 NDA NDA021067 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 220 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-1351_a9e99485-26c9-4768-abee-f6629dd7092b 0085-1351 HUMAN PRESCRIPTION DRUG REBETOL ribavirin CAPSULE ORAL 19980603 NDA NDA020903 Merck Sharp & Dohme Corp. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 0085-1366_41e18e8c-a81f-4ff1-a4a9-4434c709b059 0085-1366 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 19990811 NDA NDA021029 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0085-1370_4a46e598-5555-4800-826c-c9889ead6dd8 0085-1370 HUMAN PRESCRIPTION DRUG PEGINTRON Peginterferon alfa-2b INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20010119 BLA BLA103949 Merck Sharp & Dohme Corp. PEGINTERFERON ALFA-2B 150 ug/.5mL Interferon Alfa-2b [Chemical/Ingredient],Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] N 20181231 0085-1381_41e18e8c-a81f-4ff1-a4a9-4434c709b059 0085-1381 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090227 NDA NDA022277 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 2.5 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0085-1385_a9e99485-26c9-4768-abee-f6629dd7092b 0085-1385 HUMAN PRESCRIPTION DRUG REBETOL ribavirin CAPSULE ORAL 19980603 NDA NDA020903 Merck Sharp & Dohme Corp. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 0085-1417_41e18e8c-a81f-4ff1-a4a9-4434c709b059 0085-1417 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 19990811 NDA NDA021029 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0085-1425_41e18e8c-a81f-4ff1-a4a9-4434c709b059 0085-1425 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 19990811 NDA NDA021029 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0085-1430_41e18e8c-a81f-4ff1-a4a9-4434c709b059 0085-1430 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 19990811 NDA NDA021029 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0085-1461_5ff4ad68-7890-49f2-837b-ac9a2d76ce4d 0085-1461 HUMAN PRESCRIPTION DRUG ASMANEX Mometasone Furoate INHALANT RESPIRATORY (INHALATION) 20050330 NDA NDA021067 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 110 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-1519_41e18e8c-a81f-4ff1-a4a9-4434c709b059 0085-1519 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 19990811 NDA NDA021029 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0085-1733_9ae0561c-5e62-425f-a7f3-5cdbb842de80 0085-1733 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 19991210 NDA NDA021085 Schering Plough Corporation MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0085-1737_9ae0561c-5e62-425f-a7f3-5cdbb842de80 0085-1737 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20011130 NDA NDA021277 Schering Plough Corporation MOXIFLOXACIN HYDROCHLORIDE 400 mg/250mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 0085-3004_41e18e8c-a81f-4ff1-a4a9-4434c709b059 0085-3004 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 19990811 NDA NDA021029 Merck Sharp & Dohme Corp. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0085-3149_dffe238a-7628-420a-a99c-da4b69553ebb 0085-3149 HUMAN PRESCRIPTION DRUG ELOCON Mometasone Furoate CREAM TOPICAL 19870506 NDA NDA019625 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-3305_a3925ec2-2c8e-4c48-b4dd-d7655f823173 0085-3305 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 19950404 NDA NDA020145 Merck Sharp & Dohme Corp. NITROGLYCERIN 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0085-3310_a3925ec2-2c8e-4c48-b4dd-d7655f823173 0085-3310 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 19950404 NDA NDA020145 Merck Sharp & Dohme Corp. NITROGLYCERIN 40 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0085-3315_a3925ec2-2c8e-4c48-b4dd-d7655f823173 0085-3315 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 19950404 NDA NDA020145 Merck Sharp & Dohme Corp. NITROGLYCERIN 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0085-3320_a3925ec2-2c8e-4c48-b4dd-d7655f823173 0085-3320 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 19950404 NDA NDA020145 Merck Sharp & Dohme Corp. NITROGLYCERIN 80 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0085-3330_a3925ec2-2c8e-4c48-b4dd-d7655f823173 0085-3330 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 19950404 NDA NDA020145 Merck Sharp & Dohme Corp. NITROGLYCERIN 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0085-4320_fba8e08c-0dcb-42ad-b443-53983b429473 0085-4320 HUMAN PRESCRIPTION DRUG CELESTONE SOLUSPAN Betamethasone Acetate and Betamethasone Sodium Phosphate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20170302 NDA NDA014602 Merck Sharp & Dohme Corp. BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-4324_c702df2e-4753-4763-9d05-c22a2cb390c6 0085-4324 HUMAN PRESCRIPTION DRUG NOXAFIL posaconazole TABLET, COATED ORAL 20131125 NDA NDA205053 Merck Sharp & Dohme Corp. POSACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0085-4331_c702df2e-4753-4763-9d05-c22a2cb390c6 0085-4331 HUMAN PRESCRIPTION DRUG NOXAFIL posaconazole SOLUTION INTRAVENOUS 20140313 NDA NDA205596 Merck Sharp & Dohme Corp. POSACONAZOLE 18 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0085-4333_be997610-195c-4745-af7e-4627b0893235 0085-4333 HUMAN PRESCRIPTION DRUG ASMANEX HFA MOMETASONE FUROATE AEROSOL RESPIRATORY (INHALATION) 20140425 NDA NDA205641 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 100 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-4334_be997610-195c-4745-af7e-4627b0893235 0085-4334 HUMAN PRESCRIPTION DRUG ASMANEX HFA MOMETASONE FUROATE AEROSOL RESPIRATORY (INHALATION) 20140425 NDA NDA205641 Merck Sharp & Dohme Corp. MOMETASONE FUROATE 200 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0085-4347_d8128fbd-57b2-4364-9ff1-81cf25b6e6c7 0085-4347 HUMAN PRESCRIPTION DRUG SYLATRON peginterferon alfa-2b KIT 20140830 BLA BLA103949 Merck Sharp & Dohme Corp. N 20181231 0085-4348_d8128fbd-57b2-4364-9ff1-81cf25b6e6c7 0085-4348 HUMAN PRESCRIPTION DRUG SYLATRON peginterferon alfa-2b KIT 20110329 BLA BLA103949 Merck Sharp & Dohme Corp. N 20181231 0085-4349_d8128fbd-57b2-4364-9ff1-81cf25b6e6c7 0085-4349 HUMAN PRESCRIPTION DRUG SYLATRON peginterferon alfa-2b KIT 20110329 BLA BLA103949 Merck Sharp & Dohme Corp. N 20181231 0085-4350_14fa9d3f-4a12-4259-b2b7-217f1d1c7328 0085-4350 HUMAN PRESCRIPTION DRUG INTRON A interferon alfa-2b KIT 20140811 BLA BLA103132 Merck Sharp & Dohme Corp. N 20181231 0085-4351_14fa9d3f-4a12-4259-b2b7-217f1d1c7328 0085-4351 HUMAN PRESCRIPTION DRUG INTRON A interferon alfa-2b KIT 20140811 BLA BLA103132 Merck Sharp & Dohme Corp. N 20181231 0085-4352_14fa9d3f-4a12-4259-b2b7-217f1d1c7328 0085-4352 HUMAN PRESCRIPTION DRUG INTRON A interferon alfa-2b KIT 20140811 BLA BLA103132 Merck Sharp & Dohme Corp. N 20181231 0085-4353_4a46e598-5555-4800-826c-c9889ead6dd8 0085-4353 HUMAN PRESCRIPTION DRUG PEGINTRON peginterferon alfa-2b KIT 20140811 BLA BLA103949 Merck Sharp & Dohme Corp. N 20181231 0085-4354_4a46e598-5555-4800-826c-c9889ead6dd8 0085-4354 HUMAN PRESCRIPTION DRUG PEGINTRON peginterferon alfa-2b KIT 20140811 BLA BLA103949 Merck Sharp & Dohme Corp. N 20181231 0085-4355_4a46e598-5555-4800-826c-c9889ead6dd8 0085-4355 HUMAN PRESCRIPTION DRUG PEGINTRON peginterferon alfa-2b KIT 20140811 BLA BLA103949 Merck Sharp & Dohme Corp. N 20181231 0085-4356_4a46e598-5555-4800-826c-c9889ead6dd8 0085-4356 HUMAN PRESCRIPTION DRUG PEGINTRON peginterferon alfa-2b KIT 20140811 BLA BLA103949 Merck Sharp & Dohme Corp. N 20181231 0085-4610_69c549c3-f423-4df6-bba8-ac7f633a65d5 0085-4610 HUMAN PRESCRIPTION DRUG Dulera mometasone furoate and formoterol fumarate dihydrate AEROSOL RESPIRATORY (INHALATION) 20100622 NDA NDA022518 Merck Sharp & Dohme Corp. MOMETASONE FUROATE; FORMOTEROL FUMARATE 200; 5 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0085-7206_69c549c3-f423-4df6-bba8-ac7f633a65d5 0085-7206 HUMAN PRESCRIPTION DRUG Dulera mometasone furoate and formoterol fumarate dihydrate AEROSOL RESPIRATORY (INHALATION) 20100622 NDA NDA022518 Merck Sharp & Dohme Corp. MOMETASONE FUROATE; FORMOTEROL FUMARATE 100; 5 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0087-6060_6e251f18-a772-4bb5-83bc-2317b623c7e4 0087-6060 HUMAN PRESCRIPTION DRUG GLUCOPHAGE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20090601 NDA NDA020357 Bristol-Myers Squibb Company METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0087-6063_6e251f18-a772-4bb5-83bc-2317b623c7e4 0087-6063 HUMAN PRESCRIPTION DRUG GLUCOPHAGE XR METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20090601 NDA NDA021202 Bristol-Myers Squibb Company METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0087-6064_6e251f18-a772-4bb5-83bc-2317b623c7e4 0087-6064 HUMAN PRESCRIPTION DRUG GLUCOPHAGE XR METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20090601 NDA NDA021202 Bristol-Myers Squibb Company METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0087-6070_6e251f18-a772-4bb5-83bc-2317b623c7e4 0087-6070 HUMAN PRESCRIPTION DRUG GLUCOPHAGE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20090601 NDA NDA020357 Bristol-Myers Squibb Company METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0087-6071_6e251f18-a772-4bb5-83bc-2317b623c7e4 0087-6071 HUMAN PRESCRIPTION DRUG GLUCOPHAGE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20090601 NDA NDA020357 Bristol-Myers Squibb Company METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0087-6073_6a4cee74-60d1-488f-a9b5-4d192ba38bc5 0087-6073 HUMAN PRESCRIPTION DRUG GLUCOVANCE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20081215 NDA NDA021178 Bristol-Myers Squibb Company GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0087-6074_6a4cee74-60d1-488f-a9b5-4d192ba38bc5 0087-6074 HUMAN PRESCRIPTION DRUG GLUCOVANCE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20081215 NDA NDA021178 Bristol-Myers Squibb Company GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0087-6632_cc48a600-5591-40bb-9145-723399ac6d2a 0087-6632 HUMAN PRESCRIPTION DRUG VIDEX didanosine POWDER, FOR SOLUTION ORAL 19911009 NDA NDA020156 Bristol-Myers Squibb Company DIDANOSINE 10 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 0087-6633_cc48a600-5591-40bb-9145-723399ac6d2a 0087-6633 HUMAN PRESCRIPTION DRUG VIDEX didanosine POWDER, FOR SOLUTION ORAL 19911009 NDA NDA020156 Bristol-Myers Squibb Company DIDANOSINE 10 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 0087-6671_8b0b2dd4-6578-4a58-9401-143be6d11594 0087-6671 HUMAN PRESCRIPTION DRUG VIDEX EC didanosine CAPSULE, DELAYED RELEASE ORAL 20001031 NDA NDA021183 Bristol-Myers Squibb Company DIDANOSINE 125 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0087-6672_8b0b2dd4-6578-4a58-9401-143be6d11594 0087-6672 HUMAN PRESCRIPTION DRUG VIDEX EC didanosine CAPSULE, DELAYED RELEASE ORAL 20001031 NDA NDA021183 Bristol-Myers Squibb Company DIDANOSINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0087-6673_8b0b2dd4-6578-4a58-9401-143be6d11594 0087-6673 HUMAN PRESCRIPTION DRUG VIDEX EC didanosine CAPSULE, DELAYED RELEASE ORAL 20001031 NDA NDA021183 Bristol-Myers Squibb Company DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0087-6674_8b0b2dd4-6578-4a58-9401-143be6d11594 0087-6674 HUMAN PRESCRIPTION DRUG VIDEX EC didanosine CAPSULE, DELAYED RELEASE ORAL 20001031 NDA NDA021183 Bristol-Myers Squibb Company DIDANOSINE 400 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0088-0576_12769b20-b50a-434e-8c00-54fa7e8e318a 0088-0576 HUMAN PRESCRIPTION DRUG Rifater rifampin, isoniazid and pyrazinamide TABLET, SUGAR COATED ORAL 19940531 NDA NDA050705 sanofi-aventis U.S. LLC RIFAMPIN; ISONIAZID; PYRAZINAMIDE 120; 50; 300 mg/1; mg/1; mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient],Antimycobacterial [EPC],Antimycobacterial [EPC] N 20191231 0088-1090_0af9d08a-03a2-4626-8049-6822d108c4c0 0088-1090 HUMAN PRESCRIPTION DRUG Allegra D-12 Hour fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 19971224 NDA NDA020786 sanofi-aventis U.S. LLC FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 0088-1095_ddeb18f2-822a-45ce-b8da-5e93f185ff2b 0088-1095 HUMAN PRESCRIPTION DRUG Allegra--D 24 Hour fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED ORAL 20041019 NDA NDA021704 sanofi-aventis U.S. LLC FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 0088-1097_2892ecac-9078-460d-a940-2be297b6da59 0088-1097 HUMAN PRESCRIPTION DRUG ALLEGRA fexofenadine hydrochloride SUSPENSION ORAL 20061016 NDA NDA021963 sanofi-aventis U.S. LLC FEXOFENADINE HYDROCHLORIDE 6 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0088-1111_7fc5e6f1-25b1-45b6-9655-35d094c9cc89 0088-1111 HUMAN PRESCRIPTION DRUG Nilandron Nilutamide TABLET ORAL 19960919 NDA NDA020169 sanofi-aventis U.S. LLC NILUTAMIDE 150 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] E 20171231 0088-1202_2af2ca54-c0d7-4b54-91e4-acf6f92e5544 0088-1202 HUMAN PRESCRIPTION DRUG Anzemet dolasetron mesylate TABLET, FILM COATED ORAL 19970911 NDA NDA020623 sanofi-aventis U.S. LLC DOLASETRON MESYLATE 50 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 0088-1203_2af2ca54-c0d7-4b54-91e4-acf6f92e5544 0088-1203 HUMAN PRESCRIPTION DRUG Anzemet dolasetron mesylate TABLET, FILM COATED ORAL 19970911 NDA NDA020623 sanofi-aventis U.S. LLC DOLASETRON MESYLATE 100 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 0088-1206_9a32e15f-3a74-4fd6-934f-58f94836be80 0088-1206 HUMAN PRESCRIPTION DRUG Anzemet dolasetron mesylate INJECTION INTRAVENOUS 19970911 NDA NDA020624 sanofi-aventis U.S. LLC DOLASETRON MESYLATE 100 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 0088-1208_9a32e15f-3a74-4fd6-934f-58f94836be80 0088-1208 HUMAN PRESCRIPTION DRUG Anzemet dolasetron mesylate INJECTION INTRAVENOUS 19970911 NDA NDA020624 sanofi-aventis U.S. LLC DOLASETRON MESYLATE 12.5 mg/.625mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 0088-1209_9a32e15f-3a74-4fd6-934f-58f94836be80 0088-1209 HUMAN PRESCRIPTION DRUG Anzemet dolasetron mesylate INJECTION INTRAVENOUS 19970911 NDA NDA020624 sanofi-aventis U.S. LLC DOLASETRON MESYLATE 500 mg/25mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 0088-2100_cca47f54-0cbb-469d-8f05-bb2d35e6e3f5 0088-2100 HUMAN PRESCRIPTION DRUG Priftin rifapentine TABLET, FILM COATED ORAL 19980622 NDA NDA021024 sanofi-aventis U.S. LLC RIFAPENTINE 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 0088-2102_aa9a2225-2ddc-40f4-a39d-b95781df1b63 0088-2102 HUMAN PRESCRIPTION DRUG Priftin rifapentine TABLET, FILM COATED ORAL 20170208 NDA NDA021024 sanofi-aventis U.S. LLC RIFAPENTINE 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 0088-2160_0df41367-b205-4156-b49f-85d048f91bc3 0088-2160 HUMAN PRESCRIPTION DRUG Arava leflunomide TABLET, FILM COATED ORAL 19980910 NDA NDA020905 sanofi-aventis U.S. LLC LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] N 20181231 0088-2161_0df41367-b205-4156-b49f-85d048f91bc3 0088-2161 HUMAN PRESCRIPTION DRUG Arava leflunomide TABLET, FILM COATED ORAL 19980910 NDA NDA020905 sanofi-aventis U.S. LLC LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] N 20181231 0088-2162_0df41367-b205-4156-b49f-85d048f91bc3 0088-2162 HUMAN PRESCRIPTION DRUG Arava leflunomide TABLET, FILM COATED ORAL 19980919 NDA NDA020905 sanofi-aventis U.S. LLC LEFLUNOMIDE 100 mg/1 Antirheumatic Agent [EPC] N 20181231 0088-2219_0dd5b537-70f4-45d3-8003-8ce600908e96 0088-2219 HUMAN PRESCRIPTION DRUG Lantus Solostar insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20090923 NDA NDA021081 sanofi-aventis U.S. LLC INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0088-2220_0dd5b537-70f4-45d3-8003-8ce600908e96 0088-2220 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20090923 NDA NDA021081 sanofi-aventis U.S. LLC INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0088-2500_0d84194d-1f87-442c-ba43-5803e2d137dc 0088-2500 HUMAN PRESCRIPTION DRUG Apidra insulin glulisine INJECTION, SOLUTION SUBCUTANEOUS 20090224 NDA NDA021629 Sanofi-Aventis U.S. LLC INSULIN GLULISINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0088-2502_0d84194d-1f87-442c-ba43-5803e2d137dc 0088-2502 HUMAN PRESCRIPTION DRUG Apidra SoloStar insulin glulisine INJECTION, SOLUTION SUBCUTANEOUS 20090224 NDA NDA021629 Sanofi-Aventis U.S. LLC INSULIN GLULISINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0088-5020_8a983c38-3e88-4905-ad18-b6fa7fd48b08 0088-5020 HUMAN PRESCRIPTION DRUG Lantus Solostar insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20170604 NDA NDA021081 sanofi-aventis U.S. LLC INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0088-5021_8a983c38-3e88-4905-ad18-b6fa7fd48b08 0088-5021 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20170604 NDA NDA021081 sanofi-aventis U.S. LLC INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 00904-5899_1340298f-2e7b-4993-8122-6b0d08241c5a 00904-5899 HUMAN OTC DRUG Major Oral Pain Relief Maximum Strength Oral Anesthetic LIQUID ORAL 20080801 OTC MONOGRAPH FINAL part356 Major Pharmaceuticals BENZOCAINE 200 mg/mL N 20181231 00904-7851_1daa463f-7e91-47cb-a16d-7a95ca295b2e 00904-7851 HUMAN OTC DRUG Major Camphor and Phenol Antiseptic LIQUID TOPICAL 20080509 OTC MONOGRAPH FINAL part348 Major Pharmaceuticals CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 g/100mL; g/100mL E 20171231 0091-3707_2c711a79-fc80-331d-e054-00144ff88e88 0091-3707 HUMAN PRESCRIPTION DRUG Univasc moexipril hydrochloride TABLET, FILM COATED ORAL 19950715 NDA NDA020312 UCB, Inc. MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 0093-0010_f831eb4c-d883-44d4-818d-eb85083354e1 0093-0010 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20151101 ANDA ANDA077006 Teva Pharmaceuticals USA Inc TOLTERODINE TARTRATE 1 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0093-0011_78ff5c44-7500-4524-b299-64669a7938f8 0093-0011 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071221 ANDA ANDA077056 Teva Pharmaceuticals USA, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 0093-0012_78ff5c44-7500-4524-b299-64669a7938f8 0093-0012 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071219 ANDA ANDA077056 Teva Pharmaceuticals USA, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 0093-0017_5733f525-c05f-4256-bc1d-e1d01610059b 0093-0017 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET, FILM COATED ORAL 20030508 ANDA ANDA076204 Teva Pharmaceuticals USA Inc MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0093-0018_f831eb4c-d883-44d4-818d-eb85083354e1 0093-0018 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20151101 ANDA ANDA077006 Teva Pharmaceuticals USA Inc TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0093-0026_5c365ab1-0a95-4f91-b528-7345216c5141 0093-0026 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000823 ANDA ANDA075479 Teva Pharmaceuticals USA, Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-0027_5c365ab1-0a95-4f91-b528-7345216c5141 0093-0027 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000823 ANDA ANDA075479 Teva Pharmaceuticals USA, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-0028_5c365ab1-0a95-4f91-b528-7345216c5141 0093-0028 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000823 ANDA ANDA075479 Teva Pharmaceuticals USA, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-0029_5c365ab1-0a95-4f91-b528-7345216c5141 0093-0029 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000823 ANDA ANDA075479 Teva Pharmaceuticals USA, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-0039_1f42e295-fa94-49b7-ae9f-abf51f4946f2 0093-0039 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080722 ANDA ANDA076388 Teva Pharmaceuticals USA, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0093-0041_dba43208-815a-4159-8578-a3a0e70b804e 0093-0041 HUMAN PRESCRIPTION DRUG ClomiPHENE Citrate ClomiPHENE citrate TABLET ORAL 19921101 NDA AUTHORIZED GENERIC NDA018361 Teva Pharmaceuticals USA Inc CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0093-0050_78847e28-bef1-4e93-876b-70ee4ad76bfc 0093-0050 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19900930 ANDA ANDA088627 Teva Pharmaceuticals USA, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0093-0051_d80d00c4-d31c-4683-ada4-435aa4d54b3d 0093-0051 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA076373 Teva Pharmaceuticals USA, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0093-0053_e06690e1-c1d9-488a-bfd5-abad328493ae 0093-0053 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 Teva Pharmaceuticals USA, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 0093-0054_e06690e1-c1d9-488a-bfd5-abad328493ae 0093-0054 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 Teva Pharmaceuticals USA, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 0093-0058_945af508-e464-4b14-a8d8-4398a0c3f298 0093-0058 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20020620 ANDA ANDA075977 Teva Pharmaceuticals USA, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 0093-0064_d60f2f2d-9cd7-459a-a436-535cd566aee9 0093-0064 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA076822 Teva Pharmaceuticals USA, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 0093-0073_febcbe87-f942-4e0b-b28c-a9a2899ed492 0093-0073 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076410 Teva Pharmaceuticals USA, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0093-0074_febcbe87-f942-4e0b-b28c-a9a2899ed492 0093-0074 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076410 Teva Pharmaceuticals USA, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0093-0083_019c5d51-b8bc-4bcb-8244-4ca7fca0f208 0093-0083 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070710 ANDA ANDA076846 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0093-0090_73123aa2-f1f6-489a-abdb-813c91c41c67 0093-0090 HUMAN PRESCRIPTION DRUG Epitol Carbamazepine TABLET ORAL 19900930 ANDA ANDA070541 Teva Pharmaceuticals USA, Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0093-0109_9d24be7c-afaf-45bc-8e4f-0e0475ee95b1 0093-0109 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19900930 ANDA ANDA070541 Teva Pharmaceuticals USA Inc CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0093-0132_b7779883-d7e0-4310-94a9-c86287e2bfe6 0093-0132 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20060629 ANDA ANDA076420 Teva Pharmaceuticals USA Inc LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0093-0135_d80d00c4-d31c-4683-ada4-435aa4d54b3d 0093-0135 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA076373 Teva Pharmaceuticals USA, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0093-0150_78847e28-bef1-4e93-876b-70ee4ad76bfc 0093-0150 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19900930 ANDA ANDA088628 Teva Pharmaceuticals USA, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0093-0199_d0f2507d-9287-4aca-b388-e73a4577781f 0093-0199 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Teva Pharmaceuticals USA, Inc. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-0220_59a10f02-339c-4103-a841-76842b2ee345 0093-0220 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20090706 ANDA ANDA076932 Teva Pharmaceuticals USA, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20191231 0093-0262_c7ab0505-6b8b-4cef-a3d7-acc46cab5e5f 0093-0262 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19900930 ANDA ANDA072488 Teva Pharmaceuticals USA Inc FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0093-0263_c7ab0505-6b8b-4cef-a3d7-acc46cab5e5f 0093-0263 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19900930 ANDA ANDA072490 Teva Pharmaceuticals USA Inc FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0093-0264_c7ab0505-6b8b-4cef-a3d7-acc46cab5e5f 0093-0264 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 19920501 ANDA ANDA073481 Teva Pharmaceuticals USA Inc FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0093-0292_b256dfba-f543-4311-8339-ebf8838ae3cf 0093-0292 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930301 20180731 ANDA ANDA073618 Teva Pharmaceuticals USA, Inc. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 0093-0293_b256dfba-f543-4311-8339-ebf8838ae3cf 0093-0293 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930401 20180630 ANDA ANDA073589 Teva Pharmaceuticals USA, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 0093-0308_8d32d635-c69c-497c-95ee-aa7175172680 0093-0308 HUMAN PRESCRIPTION DRUG Clemastine Fumarate Clemastine Fumarate TABLET ORAL 19920401 ANDA ANDA073283 Teva Pharmaceuticals USA Inc CLEMASTINE FUMARATE 2.68 mg/1 N 20181231 0093-0311_dc8791f2-35b3-4594-8db6-5ad8d86fa383 0093-0311 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 Teva Pharmaceuticals USA, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 0093-0314_7fa02ccc-a8b6-4708-8dfe-633ed105d484 0093-0314 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 Teva Pharmaceuticals USA, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0093-0318_3b0d22dd-a5ce-4c78-b895-3f1b17cfdc77 0093-0318 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Teva Pharmaceuticals USA, Inc. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0093-0319_3b0d22dd-a5ce-4c78-b895-3f1b17cfdc77 0093-0319 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Teva Pharmaceuticals USA, Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0093-0320_3b0d22dd-a5ce-4c78-b895-3f1b17cfdc77 0093-0320 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Teva Pharmaceuticals USA, Inc. DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0093-0321_3b0d22dd-a5ce-4c78-b895-3f1b17cfdc77 0093-0321 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951226 ANDA ANDA074185 Teva Pharmaceuticals USA, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0093-0350_78847e28-bef1-4e93-876b-70ee4ad76bfc 0093-0350 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19900930 ANDA ANDA088629 Teva Pharmaceuticals USA, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0093-0463_1f42e295-fa94-49b7-ae9f-abf51f4946f2 0093-0463 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080722 ANDA ANDA076388 Teva Pharmaceuticals USA, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0093-0576_ab50984b-b64b-4ded-b80d-1d923c17a5a1 0093-0576 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075551 Teva Pharmaceuticals USA, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-0661_70306e9c-7542-467f-9027-2ca2e90cf21c 0093-0661 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 19920501 ANDA ANDA073419 Teva Pharmaceuticals USA Inc ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0093-0670_1827ff1f-2737-4749-9a1a-b8538d5d71c9 0093-0670 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19931124 ANDA ANDA074256 Teva Pharmaceuticals USA, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 0093-0688_b7779883-d7e0-4310-94a9-c86287e2bfe6 0093-0688 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20060828 ANDA ANDA076420 Teva Pharmaceuticals USA Inc LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0093-0711_8b9949e5-52cd-4574-be20-7e3227ecdbd5 0093-0711 HUMAN PRESCRIPTION DRUG Flurbiprofen Flurbiprofen TABLET, FILM COATED ORAL 19950602 ANDA ANDA074431 Teva Pharmaceuticals USA, Inc. FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-0733_a302d9b2-a3f6-475f-b28a-df549966aad3 0093-0733 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19950406 ANDA ANDA074141 Teva Pharmaceuticals USA Inc METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0093-0734_a302d9b2-a3f6-475f-b28a-df549966aad3 0093-0734 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19950406 ANDA ANDA074141 Teva Pharmaceuticals USA Inc METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0093-0752_b9c3b4ab-f472-44c8-85a9-69fea5dae176 0093-0752 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 Teva Pharmaceuticals USA Inc ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0093-0753_b9c3b4ab-f472-44c8-85a9-69fea5dae176 0093-0753 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950217 ANDA ANDA074056 Teva Pharmaceuticals USA Inc ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0093-0755_d736cf4f-e59d-466a-bd69-c7093ccdc395 0093-0755 HUMAN PRESCRIPTION DRUG Diflunisal Diflunisal TABLET, FILM COATED ORAL 19921101 ANDA ANDA073673 Teva Pharmaceuticals USA, Inc. DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-0756_773217e6-0c19-4e4b-aba0-760dcb4e232d 0093-0756 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19941019 ANDA ANDA074131 Teva Pharmaceuticals USA, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-0757_773217e6-0c19-4e4b-aba0-760dcb4e232d 0093-0757 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19940126 ANDA ANDA074131 Teva Pharmaceuticals USA, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-0771_e425e48c-1a6d-42f3-ae8e-03743dbe4e33 0093-0771 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 Teva Pharmaceuticals USA Inc PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-0778_9d24be7c-afaf-45bc-8e4f-0e0475ee95b1 0093-0778 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 19950918 ANDA ANDA073524 Teva Pharmaceuticals USA Inc CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0093-0782_79176633-ca8f-4061-998d-7ffa4dedf7b1 0093-0782 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20030221 20190228 ANDA ANDA074858 Teva Pharmaceuticals USA, Inc. TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 0093-0784_79176633-ca8f-4061-998d-7ffa4dedf7b1 0093-0784 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20030220 20180228 ANDA ANDA075797 Teva Pharmaceuticals USA, Inc. TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 0093-0787_b9c3b4ab-f472-44c8-85a9-69fea5dae176 0093-0787 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 Teva Pharmaceuticals USA Inc ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0093-0810_7519e378-75a5-4b98-855a-542f809eb0c2 0093-0810 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Teva Pharmaceuticals USA, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0093-0811_7519e378-75a5-4b98-855a-542f809eb0c2 0093-0811 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950406 ANDA ANDA074132 Teva Pharmaceuticals USA, Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0093-0812_7519e378-75a5-4b98-855a-542f809eb0c2 0093-0812 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Teva Pharmaceuticals USA, Inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0093-0813_7519e378-75a5-4b98-855a-542f809eb0c2 0093-0813 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Teva Pharmaceuticals USA, Inc. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0093-0819_6cdf39e4-cbf9-40f5-9ec9-809fd2392b31 0093-0819 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20010209 ANDA ANDA075289 Teva Pharmaceuticals USA Inc NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0093-0832_6415b75e-1f7c-4649-b1d1-7f4ab2a1cfd8 0093-0832 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960918 ANDA ANDA074569 Teva Pharmaceuticals USA, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0093-0833_6415b75e-1f7c-4649-b1d1-7f4ab2a1cfd8 0093-0833 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960917 ANDA ANDA074569 Teva Pharmaceuticals USA, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0093-0834_6415b75e-1f7c-4649-b1d1-7f4ab2a1cfd8 0093-0834 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960918 ANDA ANDA074569 Teva Pharmaceuticals USA, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0093-0892_c15f9d07-0949-4ab9-9da9-9cdcae4db855 0093-0892 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 Teva Pharmaceuticals USA, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-0900_edcb1bb3-0b6a-4d1e-bac6-abd822c12947 0093-0900 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075273 Teva Pharmaceuticals USA, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0093-0924_9e4ee150-a9e8-4896-892d-885a1e9cc9bd 0093-0924 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20030512 ANDA ANDA075849 Teva Pharmaceuticals USA Inc OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-0926_ab50984b-b64b-4ded-b80d-1d923c17a5a1 0093-0926 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075551 Teva Pharmaceuticals USA, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-0928_ab50984b-b64b-4ded-b80d-1d923c17a5a1 0093-0928 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075551 Teva Pharmaceuticals USA, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-0948_529491e6-e2dd-40be-b53f-fcc935ec1f68 0093-0948 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19980811 ANDA ANDA075219 Teva Pharmaceuticals USA Inc DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-0983_862dfb5f-acbe-479d-969a-f4fd261f5df7 0093-0983 HUMAN PRESCRIPTION DRUG Nystatin Nystatin TABLET, FILM COATED ORAL 19900930 ANDA ANDA062506 Teva Pharmaceuticals USA Inc NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0093-1003_e06690e1-c1d9-488a-bfd5-abad328493ae 0093-1003 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075022 Teva Pharmaceuticals USA, Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 0093-1005_e85ee157-32e0-4f4f-a3e2-aaa4257a6257 0093-1005 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980731 ANDA ANDA075227 Teva Pharmaceuticals USA, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-1006_e85ee157-32e0-4f4f-a3e2-aaa4257a6257 0093-1006 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980729 ANDA ANDA075227 Teva Pharmaceuticals USA, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-1010_54fb269e-f3e7-4a6c-b8d2-7b69d03c6c0f 0093-1010 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20031107 ANDA ANDA065085 Teva Pharmaceuticals USA, Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 0093-1015_d9e1e161-92f9-46a8-86da-45d177180795 0093-1015 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20010820 20180630 ANDA ANDA075189 Teva Pharmaceuticals USA, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-1016_d9e1e161-92f9-46a8-86da-45d177180795 0093-1016 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20010926 20180430 ANDA ANDA075189 Teva Pharmaceuticals USA, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-1024_9d324986-7cd7-4e49-8651-11aad2df633d 0093-1024 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Teva Pharmaceuticals USA Inc NEFAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 0093-1025_9d324986-7cd7-4e49-8651-11aad2df633d 0093-1025 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Teva Pharmaceuticals USA Inc NEFAZODONE HYDROCHLORIDE 200 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 0093-1026_9d324986-7cd7-4e49-8651-11aad2df633d 0093-1026 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Teva Pharmaceuticals USA Inc NEFAZODONE HYDROCHLORIDE 250 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 0093-1048_abe5ba83-2130-4af4-afd1-0ce279140459 0093-1048 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020128 ANDA ANDA075978 Teva Pharmaceuticals USA, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0093-1049_abe5ba83-2130-4af4-afd1-0ce279140459 0093-1049 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020211 ANDA ANDA075978 Teva Pharmaceuticals USA, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0093-1060_552e4578-0611-4acb-86df-28a5971cea37 0093-1060 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20000505 ANDA ANDA075429 Teva Pharmaceuticals USA, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0093-1061_552e4578-0611-4acb-86df-28a5971cea37 0093-1061 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20000504 ANDA ANDA075429 Teva Pharmaceuticals USA, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0093-1062_552e4578-0611-4acb-86df-28a5971cea37 0093-1062 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20000505 ANDA ANDA075429 Teva Pharmaceuticals USA, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0093-1063_552e4578-0611-4acb-86df-28a5971cea37 0093-1063 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20000505 ANDA ANDA075429 Teva Pharmaceuticals USA, Inc. SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0093-1077_89aa58e9-301f-4439-960a-c365b251cc90 0093-1077 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20051223 ANDA ANDA065208 Teva Pharmaceuticals USA, Inc. CEFPROZIL 250 mg/1 N 20181231 0093-1078_89aa58e9-301f-4439-960a-c365b251cc90 0093-1078 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20051223 ANDA ANDA065208 Teva Pharmaceuticals USA, Inc. CEFPROZIL 500 mg/1 N 20181231 0093-1087_ccd58d78-3934-4bd9-ab30-9627d79222d0 0093-1087 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020926 ANDA ANDA065058 Teva Pharmaceuticals USA Inc CEFACLOR 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0093-1118_9ff91524-5bb6-40f5-823f-dbbe6a01d195 0093-1118 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000817 ANDA ANDA075665 Teva Pharmaceuticals USA , Inc. ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-1122_9ff91524-5bb6-40f5-823f-dbbe6a01d195 0093-1122 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20010209 ANDA ANDA075665 Teva Pharmaceuticals USA , Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-1135_eeca0ca6-5864-496c-9706-bb48f139cab7 0093-1135 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20130719 ANDA ANDA091455 Teva Pharmaceuticals USA, Inc. ACITRETIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0093-1136_eeca0ca6-5864-496c-9706-bb48f139cab7 0093-1136 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20130719 ANDA ANDA091455 Teva Pharmaceuticals USA, Inc. ACITRETIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0093-1138_eeca0ca6-5864-496c-9706-bb48f139cab7 0093-1138 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20130719 ANDA ANDA202897 Teva Pharmaceuticals USA, Inc. ACITRETIN 17.5 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0093-1172_a993a059-e57f-471c-84da-acb642075a40 0093-1172 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 19900930 ANDA ANDA060711 Teva Pharmaceuticals USA Inc PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-1174_a993a059-e57f-471c-84da-acb642075a40 0093-1174 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 19900930 ANDA ANDA060711 Teva Pharmaceuticals USA Inc PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-1177_ab02795d-23cd-4412-9c8b-5a1dce1eb38e 0093-1177 HUMAN PRESCRIPTION DRUG Neomycin Sulfate Neomycin Sulfate TABLET ORAL 19900930 ANDA ANDA060304 Teva Pharmaceuticals USA, Inc. NEOMYCIN SULFATE 500 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 0093-1712_884733df-3bc1-4dd3-8e7e-8b3fe2c94785 0093-1712 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20151019 ANDA ANDA040616 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 0093-1713_884733df-3bc1-4dd3-8e7e-8b3fe2c94785 0093-1713 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150505 ANDA ANDA040616 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 0093-1714_884733df-3bc1-4dd3-8e7e-8b3fe2c94785 0093-1714 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150407 ANDA ANDA040616 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 0093-1715_884733df-3bc1-4dd3-8e7e-8b3fe2c94785 0093-1715 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150714 ANDA ANDA040616 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 0093-1716_884733df-3bc1-4dd3-8e7e-8b3fe2c94785 0093-1716 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150609 ANDA ANDA040616 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 0093-1718_884733df-3bc1-4dd3-8e7e-8b3fe2c94785 0093-1718 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150722 ANDA ANDA040616 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 0093-1719_884733df-3bc1-4dd3-8e7e-8b3fe2c94785 0093-1719 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150609 ANDA ANDA040616 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 0093-1720_884733df-3bc1-4dd3-8e7e-8b3fe2c94785 0093-1720 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150512 ANDA ANDA040616 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 0093-1721_884733df-3bc1-4dd3-8e7e-8b3fe2c94785 0093-1721 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150407 ANDA ANDA040616 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 0093-1893_c15f9d07-0949-4ab9-9da9-9cdcae4db855 0093-1893 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20090909 ANDA ANDA075009 Teva Pharmaceuticals USA, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-2013_82bca25b-2a51-4867-a87b-735ed49f877e 0093-2013 HUMAN PRESCRIPTION DRUG Sumatriptan sumatriptan succinate INJECTION SUBCUTANEOUS 20160601 ANDA ANDA078319 Teva Pharmaceuticals USA Inc SUMATRIPTAN SUCCINATE 4 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0093-2014_82bca25b-2a51-4867-a87b-735ed49f877e 0093-2014 HUMAN PRESCRIPTION DRUG Sumatriptan sumatriptan succinate INJECTION SUBCUTANEOUS 20160601 ANDA ANDA078319 Teva Pharmaceuticals USA Inc SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0093-2026_ea432ae0-8fa8-41e7-8166-97b446eae086 0093-2026 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101217 ANDA ANDA065246 Teva Pharmaceuticals USA, Inc. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0093-2027_ea432ae0-8fa8-41e7-8166-97b446eae086 0093-2027 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101228 ANDA ANDA065246 Teva Pharmaceuticals USA, Inc. AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0093-2046_3c52f60a-9068-4606-8056-02cebd614d74 0093-2046 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Teva Pharmaceuticals USA Inc PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 0093-2047_3c52f60a-9068-4606-8056-02cebd614d74 0093-2047 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Teva Pharmaceuticals USA Inc PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 0093-2048_3c52f60a-9068-4606-8056-02cebd614d74 0093-2048 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Teva Pharmaceuticals USA Inc PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 0093-2049_7e53e3b5-d888-4137-86fb-f5d4a46355d4 0093-2049 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20140102 NDA AUTHORIZED GENERIC NDA021228 Teva Pharmaceuticals USA Inc TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 0093-2050_7e53e3b5-d888-4137-86fb-f5d4a46355d4 0093-2050 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20140102 NDA AUTHORIZED GENERIC NDA021228 Teva Pharmaceuticals USA Inc TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 0093-2055_5c48e761-a899-432a-a4d6-40b900d9eb48 0093-2055 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20120511 NDA AUTHORIZED GENERIC NDA020771 Teva Pharmaceuticals USA Inc TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0093-2056_5c48e761-a899-432a-a4d6-40b900d9eb48 0093-2056 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20120511 NDA AUTHORIZED GENERIC NDA020771 Teva Pharmaceuticals USA Inc TOLTERODINE TARTRATE 1 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0093-2060_32228020-6760-12fe-5fd9-e503993069da 0093-2060 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Teva Pharmaceuticals USA Inc FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0093-2061_32228020-6760-12fe-5fd9-e503993069da 0093-2061 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Teva Pharmaceuticals USA Inc FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0093-2063_318c525a-2f68-4d04-9553-0ff89b159365 0093-2063 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20140312 ANDA ANDA077745 Teva Pharmaceuticals USA, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-2064_1cf5c7a5-a0e9-49e4-99e3-e62b76917283 0093-2064 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20121024 ANDA ANDA077027 Teva Pharmaceuticals USA Inc CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0093-2065_1cf5c7a5-a0e9-49e4-99e3-e62b76917283 0093-2065 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20120424 ANDA ANDA077027 Teva Pharmaceuticals USA Inc CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0093-2067_5d0dd2f2-e3b4-4af0-920b-60a723e481a8 0093-2067 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20141205 ANDA ANDA075536 Teva Pharmaceuticals USA, Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0093-2068_5d0dd2f2-e3b4-4af0-920b-60a723e481a8 0093-2068 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20140909 ANDA ANDA075536 Teva Pharmaceuticals USA, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0093-2069_5d0dd2f2-e3b4-4af0-920b-60a723e481a8 0093-2069 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20140806 ANDA ANDA075536 Teva Pharmaceuticals USA, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0093-2070_5d0dd2f2-e3b4-4af0-920b-60a723e481a8 0093-2070 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20140806 ANDA ANDA075536 Teva Pharmaceuticals USA, Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0093-2140_5c6d5f13-e1ed-4e64-8858-a02244d71af1 0093-2140 HUMAN PRESCRIPTION DRUG Tri-Lo-Sprintec Norgestimate and Ethinyl Estradiol KIT 20151230 ANDA ANDA076784 Teva Pharmaceuticals USA, Inc. N 20181231 0093-2203_853a50ff-f7b7-47a8-bb10-83d9129c74e8 0093-2203 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Teva Pharmaceuticals USA, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0093-2204_853a50ff-f7b7-47a8-bb10-83d9129c74e8 0093-2204 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19930701 ANDA ANDA072801 Teva Pharmaceuticals USA, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0093-2210_54ec100a-5348-4383-b97c-20c5cf48bde5 0093-2210 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961111 ANDA ANDA070848 Teva Pharmaceuticals USA, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 0093-2238_e18be28d-1a66-4cb2-a3e4-6b19c44c5507 0093-2238 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin TABLET ORAL 19900930 ANDA ANDA063023 Teva Pharmaceuticals USA, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0093-2240_e18be28d-1a66-4cb2-a3e4-6b19c44c5507 0093-2240 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin TABLET ORAL 19900930 ANDA ANDA063024 Teva Pharmaceuticals USA, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0093-2263_721a26c8-ff84-4fdb-a561-a6d1ea118bf0 0093-2263 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20001121 ANDA ANDA065056 Teva Pharmaceuticals USA Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-2264_721a26c8-ff84-4fdb-a561-a6d1ea118bf0 0093-2264 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20000926 ANDA ANDA065056 Teva Pharmaceuticals USA Inc AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-2267_46e8da4e-9ebe-4636-9981-933bbc158b68 0093-2267 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 19951001 ANDA ANDA064013 Teva Pharmaceuticals USA Inc AMOXICILLIN 125 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-2268_46e8da4e-9ebe-4636-9981-933bbc158b68 0093-2268 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 19930101 ANDA ANDA064013 Teva Pharmaceuticals USA Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-2270_66b5ed3b-d7af-41eb-8746-96066cbf5d91 0093-2270 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20050322 ANDA ANDA065205 Teva Pharmaceuticals USA, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 0093-2272_66b5ed3b-d7af-41eb-8746-96066cbf5d91 0093-2272 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20050210 ANDA ANDA065205 Teva Pharmaceuticals USA, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 0093-2274_66b5ed3b-d7af-41eb-8746-96066cbf5d91 0093-2274 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 Teva Pharmaceuticals USA, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 0093-2275_66b5ed3b-d7af-41eb-8746-96066cbf5d91 0093-2275 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 Teva Pharmaceuticals USA, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 0093-2277_66b5ed3b-d7af-41eb-8746-96066cbf5d91 0093-2277 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20050113 ANDA ANDA065089 Teva Pharmaceuticals USA, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 0093-2279_66b5ed3b-d7af-41eb-8746-96066cbf5d91 0093-2279 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20050113 ANDA ANDA065089 Teva Pharmaceuticals USA, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 0093-2748_047aa26e-0911-4537-8ab7-10a1dfe3a308 0093-2748 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20150108 ANDA ANDA075512 Teva Pharmaceuticals USA, Inc. FAMOTIDINE 10 mg/1 N 20181231 0093-2929_aaf9fb05-07ab-479e-8604-16c6aafd2fcd 0093-2929 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20090123 ANDA ANDA087056 Teva Pharmaceuticals USA Inc CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 0093-2931_2d56136a-9922-4bc6-84ea-d02556511783 0093-2931 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20090223 ANDA ANDA070098 Teva Pharmaceuticals USA Inc METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0093-2932_2d56136a-9922-4bc6-84ea-d02556511783 0093-2932 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20090428 ANDA ANDA070343 Teva Pharmaceuticals USA Inc METHYLDOPA 500 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0093-3002_1ba5baff-5f55-42ec-80d5-000181e12576 0093-3002 HUMAN PRESCRIPTION DRUG Quinine Sulfate Quinine Sulfate CAPSULE ORAL 20120928 ANDA ANDA091661 Teva Pharmaceuticals USA Inc QUININE SULFATE 324 mg/1 Antimalarial [EPC] N 20181231 0093-3010_9971a36e-e44c-4e13-a132-8a5a79580f92 0093-3010 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET, ORALLY DISINTEGRATING ORAL 20120830 NDA AUTHORIZED GENERIC NDA021590 Teva Pharmaceuticals USA Inc CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-3011_9971a36e-e44c-4e13-a132-8a5a79580f92 0093-3011 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET, ORALLY DISINTEGRATING ORAL 20120830 NDA AUTHORIZED GENERIC NDA021590 Teva Pharmaceuticals USA Inc CLOZAPINE 12.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-3012_9971a36e-e44c-4e13-a132-8a5a79580f92 0093-3012 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET, ORALLY DISINTEGRATING ORAL 20120830 NDA AUTHORIZED GENERIC NDA021590 Teva Pharmaceuticals USA Inc CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-3040_a82a35f5-2a9e-42c6-8598-06278e8ff939 0093-3040 HUMAN PRESCRIPTION DRUG Aspirin and Dipyridamole Aspirin and Dipyridamole CAPSULE, EXTENDED RELEASE ORAL 20150701 NDA AUTHORIZED GENERIC NDA020884 Teva Pharmaceuticals USA, Inc. ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0093-3043_350f4568-6129-42f1-a945-435ef66bf7ff 0093-3043 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140310 ANDA ANDA074587 Teva Pharmaceuticals USA Inc VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0093-3044_350f4568-6129-42f1-a945-435ef66bf7ff 0093-3044 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140129 ANDA ANDA074587 Teva Pharmaceuticals USA Inc VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0093-3045_350f4568-6129-42f1-a945-435ef66bf7ff 0093-3045 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140407 ANDA ANDA074587 Teva Pharmaceuticals USA Inc VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0093-3060_1918ac98-0600-4b06-baa1-9b4ea4a63e4c 0093-3060 HUMAN PRESCRIPTION DRUG Rasagiline Rasagiline TABLET ORAL 20170103 NDA AUTHORIZED GENERIC NDA021641 Teva Pharmaceuticals USA, Inc. RASAGILINE MESYLATE .5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 0093-3061_1918ac98-0600-4b06-baa1-9b4ea4a63e4c 0093-3061 HUMAN PRESCRIPTION DRUG Rasagiline Rasagiline TABLET ORAL 20170103 NDA AUTHORIZED GENERIC NDA021641 Teva Pharmaceuticals USA, Inc. RASAGILINE MESYLATE 1 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 0093-3086_9971a36e-e44c-4e13-a132-8a5a79580f92 0093-3086 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET, ORALLY DISINTEGRATING ORAL 20150505 NDA AUTHORIZED GENERIC NDA021590 Teva Pharmaceuticals USA Inc CLOZAPINE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-3087_9971a36e-e44c-4e13-a132-8a5a79580f92 0093-3087 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET, ORALLY DISINTEGRATING ORAL 20150505 NDA AUTHORIZED GENERIC NDA021590 Teva Pharmaceuticals USA Inc CLOZAPINE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-3090_43e4648e-388b-4fa6-9f79-51f2cbe50978 0093-3090 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161129 NDA AUTHORIZED GENERIC NDA021875 Teva Pharmaceuticals USA, Inc. ARMODAFINIL 50 mg/1 CIV N 20181231 0093-3092_43e4648e-388b-4fa6-9f79-51f2cbe50978 0093-3092 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161129 NDA AUTHORIZED GENERIC NDA021875 Teva Pharmaceuticals USA, Inc. ARMODAFINIL 150 mg/1 CIV N 20181231 0093-3093_43e4648e-388b-4fa6-9f79-51f2cbe50978 0093-3093 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161129 NDA AUTHORIZED GENERIC NDA021875 Teva Pharmaceuticals USA, Inc. ARMODAFINIL 200 mg/1 CIV N 20181231 0093-3094_43e4648e-388b-4fa6-9f79-51f2cbe50978 0093-3094 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161129 NDA AUTHORIZED GENERIC NDA021875 Teva Pharmaceuticals USA, Inc. ARMODAFINIL 250 mg/1 CIV N 20181231 0093-3098_5bc22e90-7ba8-4434-9806-667493a7bef8 0093-3098 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20150601 ANDA ANDA077132 Teva Pharmaceuticals USA Inc RISEDRONATE SODIUM MONOHYDRATE 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0093-3099_5bc22e90-7ba8-4434-9806-667493a7bef8 0093-3099 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20150601 ANDA ANDA077132 Teva Pharmaceuticals USA Inc RISEDRONATE SODIUM MONOHYDRATE 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0093-3100_5bc22e90-7ba8-4434-9806-667493a7bef8 0093-3100 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20150601 ANDA ANDA077132 Teva Pharmaceuticals USA Inc RISEDRONATE SODIUM MONOHYDRATE 30 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0093-3107_46e8da4e-9ebe-4636-9981-933bbc158b68 0093-3107 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19900930 ANDA ANDA061926 Teva Pharmaceuticals USA Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-3109_46e8da4e-9ebe-4636-9981-933bbc158b68 0093-3109 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19900930 ANDA ANDA061926 Teva Pharmaceuticals USA Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-3122_1a354778-1b22-4094-ac4b-30ea15f9507e 0093-3122 HUMAN PRESCRIPTION DRUG Jinteli norethindrone acetate and ethinyl estradiol TABLET ORAL 20110217 ANDA ANDA076221 Teva Pharmaceuticals USA Inc NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; 5 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0093-3123_1f8dd4f4-30f5-4029-9743-5f4d4769da3b 0093-3123 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 Teva Pharmaceuticals USA Inc DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-3125_1f8dd4f4-30f5-4029-9743-5f4d4769da3b 0093-3125 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 Teva Pharmaceuticals USA Inc DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-3127_429d31c5-cb94-4db7-99c1-3d09250dc001 0093-3127 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 19900930 ANDA ANDA070101 Teva Pharmaceuticals USA Inc DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 0093-3129_429d31c5-cb94-4db7-99c1-3d09250dc001 0093-3129 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 19900930 ANDA ANDA070102 Teva Pharmaceuticals USA Inc DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 0093-3134_b817ea58-8925-49e2-a27a-e234cbdf0ff5 0093-3134 HUMAN PRESCRIPTION DRUG Camrese Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol KIT 20110728 NDA AUTHORIZED GENERIC NDA021840 Teva Pharmaceuticals USA ,Inc. N 20181231 0093-3145_e18be28d-1a66-4cb2-a3e4-6b19c44c5507 0093-3145 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 19900930 ANDA ANDA062702 Teva Pharmaceuticals USA, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0093-3147_e18be28d-1a66-4cb2-a3e4-6b19c44c5507 0093-3147 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 19900930 ANDA ANDA062702 Teva Pharmaceuticals USA, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0093-3160_1b9f91bc-fff6-466c-a371-3a2a94cb3fc4 0093-3160 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070509 ANDA ANDA065368 Teva Pharmaceuticals USA Inc CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0093-3165_d43f6d3c-4be8-4a14-bc53-fe86e698a305 0093-3165 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19920501 20180430 ANDA ANDA063011 Teva Pharmaceuticals USA, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 0093-3167_d43f6d3c-4be8-4a14-bc53-fe86e698a305 0093-3167 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19920501 20190131 ANDA ANDA063009 Teva Pharmaceuticals USA, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 0093-3193_e5448653-6fff-4a3d-924b-d2c6fa1732f2 0093-3193 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073516 Teva Pharmaceuticals USA, Inc. KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-3195_e5448653-6fff-4a3d-924b-d2c6fa1732f2 0093-3195 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073517 Teva Pharmaceuticals USA, Inc. KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-3196_061ef414-4bc6-461c-bc95-f71de2055b2e 0093-3196 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070131 ANDA ANDA065282 Teva Pharmaceuticals USA Inc CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0093-3223_302d57d0-606e-4312-bbfc-22b948d9763d 0093-3223 HUMAN PRESCRIPTION DRUG Estradiol Estradiol INSERT VAGINAL 20170724 ANDA ANDA206388 Teva Pharmaceuticals USA, Inc. ESTRADIOL 10 ug/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0093-3230_624e2a34-35b2-5cf8-e053-2a91aa0af748 0093-3230 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (LA) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20180102 ANDA ANDA078458 Teva Pharmaceuticals USA, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0093-3231_624e2a34-35b2-5cf8-e053-2a91aa0af748 0093-3231 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (LA) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20180102 ANDA ANDA078458 Teva Pharmaceuticals USA, Inc. METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0093-3232_624e2a34-35b2-5cf8-e053-2a91aa0af748 0093-3232 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (LA) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20180102 ANDA ANDA078458 Teva Pharmaceuticals USA, Inc. METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0093-3303_444cf9c4-b36e-4180-902d-5ec87e43564d 0093-3303 HUMAN PRESCRIPTION DRUG Necon 1/35 (28 Day Regimen) Norethindrone and Ethinyl Estradiol KIT 20161201 ANDA ANDA072696 Teva Pharmaceuticals USA, Inc. N 20181231 0093-3304_2dedcd68-1ffd-452a-8f8e-ce5d1be7703a 0093-3304 HUMAN PRESCRIPTION DRUG Reclipsen 28 Day Desogestrel and Ethinyl Estradiol KIT 20170101 ANDA ANDA075256 Teva Pharmaceuticals USA, Inc. N 20181231 0093-3305_c1f92681-0133-44fa-8a4d-db48cd792761 0093-3305 HUMAN PRESCRIPTION DRUG Zenchent 0.4/35 Norethindrone and Ethinyl Estradiol KIT 20170406 ANDA ANDA076238 Teva Pharmaceuticals USA, Inc. N 20181231 0093-3541_b2256394-5872-4682-b42f-498ebd29eda5 0093-3541 HUMAN PRESCRIPTION DRUG Estradiol Estradiol CREAM VAGINAL 20180102 ANDA ANDA086069 Teva Pharmaceuticals USA, Inc. ESTRADIOL .1 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20191231 0093-3542_84f539d8-946c-4619-81fe-693558d96659 0093-3542 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079022 Teva Pharmaceuticals USA, Inc. ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0093-3543_84f539d8-946c-4619-81fe-693558d96659 0093-3543 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079022 Teva Pharmaceuticals USA, Inc. ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0093-3544_84f539d8-946c-4619-81fe-693558d96659 0093-3544 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079022 Teva Pharmaceuticals USA, Inc. ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0093-3545_84f539d8-946c-4619-81fe-693558d96659 0093-3545 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079022 Teva Pharmaceuticals USA, Inc. ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0093-3546_84f539d8-946c-4619-81fe-693558d96659 0093-3546 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079022 Teva Pharmaceuticals USA, Inc. ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0093-3547_84f539d8-946c-4619-81fe-693558d96659 0093-3547 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079022 Teva Pharmaceuticals USA, Inc. ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0093-3548_84f539d8-946c-4619-81fe-693558d96659 0093-3548 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079022 Teva Pharmaceuticals USA, Inc. ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0093-3600_6f01f14e-5b47-4544-9656-d471cebe03ee 0093-3600 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20170530 NDA AUTHORIZED GENERIC NDA021306 Teva Pharmaceuticals USA, Inc. BUPRENORPHINE 5 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 0093-3601_6f01f14e-5b47-4544-9656-d471cebe03ee 0093-3601 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20170530 NDA AUTHORIZED GENERIC NDA021306 Teva Pharmaceuticals USA, Inc. BUPRENORPHINE 10 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 0093-3602_6f01f14e-5b47-4544-9656-d471cebe03ee 0093-3602 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20170530 NDA AUTHORIZED GENERIC NDA021306 Teva Pharmaceuticals USA, Inc. BUPRENORPHINE 15 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 0093-3603_6f01f14e-5b47-4544-9656-d471cebe03ee 0093-3603 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20170530 NDA AUTHORIZED GENERIC NDA021306 Teva Pharmaceuticals USA, Inc. BUPRENORPHINE 20 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 0093-3607_d6c98263-872b-4eec-85c7-3a8d7a681091 0093-3607 HUMAN PRESCRIPTION DRUG Fluticasone Propionate and Salmeterol Fluticasone Propionate and Salmeterol POWDER, METERED RESPIRATORY (INHALATION) 20170428 NDA AUTHORIZED GENERIC NDA208799 Teva Pharmaceuticals USA, Inc. FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 55; 14 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0093-3608_d6c98263-872b-4eec-85c7-3a8d7a681091 0093-3608 HUMAN PRESCRIPTION DRUG Fluticasone Propionate and Salmeterol Fluticasone Propionate and Salmeterol POWDER, METERED RESPIRATORY (INHALATION) 20170428 NDA AUTHORIZED GENERIC NDA208799 Teva Pharmaceuticals USA, Inc. FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 113; 14 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0093-3609_d6c98263-872b-4eec-85c7-3a8d7a681091 0093-3609 HUMAN PRESCRIPTION DRUG Fluticasone Propionate and Salmeterol Fluticasone Propionate and Salmeterol POWDER, METERED RESPIRATORY (INHALATION) 20170428 NDA AUTHORIZED GENERIC NDA208799 Teva Pharmaceuticals USA, Inc. FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 232; 14 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0093-4029_bea19b1e-f569-4211-9001-7df21ff1e139 0093-4029 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20071214 ANDA ANDA070719 Teva Pharmaceuticals USA Inc INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-4030_bea19b1e-f569-4211-9001-7df21ff1e139 0093-4030 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20071214 ANDA ANDA070756 Teva Pharmaceuticals USA Inc INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-4059_5950969d-6cbb-4327-a649-af4b77b39692 0093-4059 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil TABLET ORAL 20070131 ANDA ANDA062774 Teva Pharmaceuticals USA Inc CEFADROXIL 1000 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0093-4067_f7e4a650-7b7b-41dd-b163-7d8857251fc3 0093-4067 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071745 Teva Pharmaceuticals USA, Inc. PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0093-4068_f7e4a650-7b7b-41dd-b163-7d8857251fc3 0093-4068 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071745 Teva Pharmaceuticals USA, Inc. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0093-4069_f7e4a650-7b7b-41dd-b163-7d8857251fc3 0093-4069 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070118 ANDA ANDA071745 Teva Pharmaceuticals USA, Inc. PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0093-4085_cd43937e-cc48-49f9-a282-8676b5b50c55 0093-4085 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION RESPIRATORY (INHALATION) 20131119 ANDA ANDA091589 Teva Pharmaceuticals USA Inc TOBRAMYCIN 300 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0093-4125_a993a059-e57f-471c-84da-acb642075a40 0093-4125 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19900930 ANDA ANDA060456 Teva Pharmaceuticals USA Inc PENICILLIN V POTASSIUM 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-4127_a993a059-e57f-471c-84da-acb642075a40 0093-4127 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19900930 ANDA ANDA060456 Teva Pharmaceuticals USA Inc PENICILLIN V POTASSIUM 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-4136_51369e23-02c4-4a1b-930c-d81627510b85 0093-4136 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070508 ANDA ANDA065332 Teva Pharmaceuticals USA Inc CEFDINIR MONOHYDRATE 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0093-4137_51369e23-02c4-4a1b-930c-d81627510b85 0093-4137 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070508 ANDA ANDA065332 Teva Pharmaceuticals USA Inc CEFDINIR MONOHYDRATE 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0093-4145_8526cc18-9c19-4385-9d39-a3af63741436 0093-4145 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130429 ANDA ANDA090297 Teva Pharmaceuticals USA, Inc. LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0093-4146_8526cc18-9c19-4385-9d39-a3af63741436 0093-4146 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130429 ANDA ANDA090297 Teva Pharmaceuticals USA, Inc. LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0093-4147_dbc65c8b-22f4-4ae1-bd95-81e84dfca77d 0093-4147 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION, CONCENTRATE RESPIRATORY (INHALATION) 20141216 ANDA ANDA200875 Teva Pharmaceuticals USA, Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0093-4148_8526cc18-9c19-4385-9d39-a3af63741436 0093-4148 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130429 ANDA ANDA090297 Teva Pharmaceuticals USA, Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0093-4150_46e8da4e-9ebe-4636-9981-933bbc158b68 0093-4150 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 Teva Pharmaceuticals USA Inc AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-4155_46e8da4e-9ebe-4636-9981-933bbc158b68 0093-4155 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 Teva Pharmaceuticals USA Inc AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-4160_ad24dd91-66f2-470a-803e-df2b9c744d8e 0093-4160 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20030402 ANDA ANDA065119 Teva Pharmaceuticals USA Inc AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-4161_ad24dd91-66f2-470a-803e-df2b9c744d8e 0093-4161 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20030226 ANDA ANDA065119 Teva Pharmaceuticals USA Inc AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0093-4175_e18be28d-1a66-4cb2-a3e4-6b19c44c5507 0093-4175 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 Teva Pharmaceuticals USA, Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0093-4177_e18be28d-1a66-4cb2-a3e4-6b19c44c5507 0093-4177 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 Teva Pharmaceuticals USA, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0093-4232_cf5bdbcd-f4c8-46dc-98eb-d6a6f22788fe 0093-4232 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Teva Pharmaceuticals USA Inc BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0093-4233_cf5bdbcd-f4c8-46dc-98eb-d6a6f22788fe 0093-4233 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Teva Pharmaceuticals USA Inc BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0093-4234_cf5bdbcd-f4c8-46dc-98eb-d6a6f22788fe 0093-4234 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Teva Pharmaceuticals USA Inc BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0093-4235_83539758-6c72-4707-9e63-5a2499d3f99a 0093-4235 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081103 ANDA ANDA074229 Teva Pharmaceuticals USA Inc NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0093-4236_83539758-6c72-4707-9e63-5a2499d3f99a 0093-4236 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081103 ANDA ANDA074229 Teva Pharmaceuticals USA Inc NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0093-4237_83539758-6c72-4707-9e63-5a2499d3f99a 0093-4237 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081103 ANDA ANDA074255 Teva Pharmaceuticals USA Inc NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0093-4359_f1b99c9a-4b5b-41c5-9bf9-e392dde9f6e7 0093-4359 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20070510 ANDA ANDA074949 Teva Pharmaceuticals USA, Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-4404_f1b99c9a-4b5b-41c5-9bf9-e392dde9f6e7 0093-4404 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20070319 ANDA ANDA076809 Teva Pharmaceuticals USA, Inc. CLOZAPINE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-4405_f1b99c9a-4b5b-41c5-9bf9-e392dde9f6e7 0093-4405 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20070515 ANDA ANDA076809 Teva Pharmaceuticals USA, Inc. CLOZAPINE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-4443_9c6b5ae5-2d96-4786-b88a-c0a76811ec64 0093-4443 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20080711 ANDA ANDA076017 Teva Pharmaceuticals USA, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0093-4444_9c6b5ae5-2d96-4786-b88a-c0a76811ec64 0093-4444 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20080801 ANDA ANDA076017 Teva Pharmaceuticals USA, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0093-5002_28cad133-dbf9-4a71-998a-2fa4a81e69c5 0093-5002 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide TABLET, FILM COATED ORAL 20161114 ANDA ANDA202491 Teva Pharmaceuticals USA, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 10; 25 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-5003_28cad133-dbf9-4a71-998a-2fa4a81e69c5 0093-5003 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide TABLET, FILM COATED ORAL 20161114 ANDA ANDA202491 Teva Pharmaceuticals USA, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 10; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-5004_28cad133-dbf9-4a71-998a-2fa4a81e69c5 0093-5004 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide TABLET, FILM COATED ORAL 20161114 ANDA ANDA202491 Teva Pharmaceuticals USA, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 5; 25 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-5005_28cad133-dbf9-4a71-998a-2fa4a81e69c5 0093-5005 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide TABLET, FILM COATED ORAL 20161114 ANDA ANDA202491 Teva Pharmaceuticals USA, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 20; 5; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-5006_28cad133-dbf9-4a71-998a-2fa4a81e69c5 0093-5006 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide TABLET, FILM COATED ORAL 20161114 ANDA ANDA202491 Teva Pharmaceuticals USA, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 5; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-5030_02b715ab-edd5-4d15-ac64-26521937b4b8 0093-5030 HUMAN PRESCRIPTION DRUG Tiagabine Hydrochloride Tiagabine Hydrochloride TABLET, FILM COATED ORAL 20160603 NDA AUTHORIZED GENERIC NDA020646 Teva Pharmaceuticals USA, Inc. TIAGABINE HYDROCHLORIDE 2 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0093-5031_02b715ab-edd5-4d15-ac64-26521937b4b8 0093-5031 HUMAN PRESCRIPTION DRUG Tiagabine Hydrochloride Tiagabine Hydrochloride TABLET, FILM COATED ORAL 20160718 NDA AUTHORIZED GENERIC NDA020646 Teva Pharmaceuticals USA, Inc. TIAGABINE HYDROCHLORIDE 4 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0093-5035_c6f89243-0832-4dfe-9eab-ef2522beb628 0093-5035 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20110415 ANDA ANDA088482 Teva Pharmaceuticals USA, Inc. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 0093-5036_c6f89243-0832-4dfe-9eab-ef2522beb628 0093-5036 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20110719 ANDA ANDA088483 Teva Pharmaceuticals USA, Inc. DISULFIRAM 500 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 0093-5045_bf59fedb-4d5c-41d4-b652-f55e813f5c27 0093-5045 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170705 ANDA ANDA202731 Teva Pharmaceuticals USA, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 25 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5046_bf59fedb-4d5c-41d4-b652-f55e813f5c27 0093-5046 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170705 ANDA ANDA202731 Teva Pharmaceuticals USA, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 35 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5049_739decb0-91d9-4559-b1ee-2531c0667d8e 0093-5049 HUMAN PRESCRIPTION DRUG Pioglitazone and Metformin Hydrocholride pioglitazone and metformin hydrochloride TABLET, FILM COATED ORAL 20120817 NDA AUTHORIZED GENERIC NDA021842 Teva Pharmaceuticals USA PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 500 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 0093-5050_739decb0-91d9-4559-b1ee-2531c0667d8e 0093-5050 HUMAN PRESCRIPTION DRUG Pioglitazone and Metformin Hydrocholride pioglitazone and metformin hydrochloride TABLET, FILM COATED ORAL 20120817 NDA AUTHORIZED GENERIC NDA021842 Teva Pharmaceuticals USA PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 850 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 0093-5056_0ee88d50-266d-4f03-843d-58509febe342 0093-5056 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20170504 ANDA ANDA205300 Teva Pharmaceuticals USA, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 0093-5057_0ee88d50-266d-4f03-843d-58509febe342 0093-5057 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20170504 ANDA ANDA205300 Teva Pharmaceuticals USA, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 0093-5058_0ee88d50-266d-4f03-843d-58509febe342 0093-5058 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20170504 ANDA ANDA205300 Teva Pharmaceuticals USA, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 0093-5059_0ee88d50-266d-4f03-843d-58509febe342 0093-5059 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20170504 ANDA ANDA205300 Teva Pharmaceuticals USA, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 0093-5060_adb91252-7e8e-41d4-b19f-c775f75b3e8b 0093-5060 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20130219 ANDA ANDA088617 Teva Pharmaceuticals USA, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0093-5061_adb91252-7e8e-41d4-b19f-c775f75b3e8b 0093-5061 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20121009 ANDA ANDA088618 Teva Pharmaceuticals USA, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0093-5062_adb91252-7e8e-41d4-b19f-c775f75b3e8b 0093-5062 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20121022 ANDA ANDA088619 Teva Pharmaceuticals USA, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0093-5105_7baa4d4d-abad-b57c-1cc8-572c7031e92f 0093-5105 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076133 Teva Pharmaceuticals USA Inc OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-5112_130f8098-ebda-4cb7-9337-3e4b621e48dd 0093-5112 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 20180831 ANDA ANDA075116 Teva Pharmaceuticals USA Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 0093-5116_50d43265-faf4-42c7-b69f-261f3eb16341 0093-5116 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, EXTENDED RELEASE ORAL 19980731 ANDA ANDA075028 Teva Pharmaceuticals USA Inc PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 0093-5117_130f8098-ebda-4cb7-9337-3e4b621e48dd 0093-5117 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 20180831 ANDA ANDA075116 Teva Pharmaceuticals USA Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 0093-5118_130f8098-ebda-4cb7-9337-3e4b621e48dd 0093-5118 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 20180930 ANDA ANDA075116 Teva Pharmaceuticals USA Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 0093-5119_130f8098-ebda-4cb7-9337-3e4b621e48dd 0093-5119 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 20180731 ANDA ANDA075116 Teva Pharmaceuticals USA Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 0093-5124_a79824a9-c300-4bee-b7bc-fda8e43b617f 0093-5124 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 Teva Pharmaceuticals USA, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-5125_a79824a9-c300-4bee-b7bc-fda8e43b617f 0093-5125 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 Teva Pharmaceuticals USA, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-5126_a79824a9-c300-4bee-b7bc-fda8e43b617f 0093-5126 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 Teva Pharmaceuticals USA, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-5127_a79824a9-c300-4bee-b7bc-fda8e43b617f 0093-5127 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 Teva Pharmaceuticals USA, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-5140_210d782e-78d7-46b0-8c69-5f9801ef6b88 0093-5140 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 20180630 ANDA ANDA075710 Teva Pharmaceuticals USA, Inc. ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0093-5141_210d782e-78d7-46b0-8c69-5f9801ef6b88 0093-5141 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 20180531 ANDA ANDA075710 Teva Pharmaceuticals USA, Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0093-5142_210d782e-78d7-46b0-8c69-5f9801ef6b88 0093-5142 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 20180531 ANDA ANDA075710 Teva Pharmaceuticals USA, Inc. ALENDRONATE SODIUM 40 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0093-5150_5733f525-c05f-4256-bc1d-e1d01610059b 0093-5150 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET, FILM COATED ORAL 20030508 ANDA ANDA076204 Teva Pharmaceuticals USA Inc MOEXIPRIL HYDROCHLORIDE 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0093-5171_210d782e-78d7-46b0-8c69-5f9801ef6b88 0093-5171 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 20180531 ANDA ANDA075710 Teva Pharmaceuticals USA, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0093-5173_6cdf39e4-cbf9-40f5-9ec9-809fd2392b31 0093-5173 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20001211 ANDA ANDA075289 Teva Pharmaceuticals USA Inc NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0093-5200_e06690e1-c1d9-488a-bfd5-abad328493ae 0093-5200 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20040326 ANDA ANDA075022 Teva Pharmaceuticals USA, Inc. BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 0093-5206_39a9c6f5-f8ab-4346-9bc6-e62c53069d63 0093-5206 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20070511 ANDA ANDA076745 TEVA Pharmaceuticals USA Inc OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0093-5207_39a9c6f5-f8ab-4346-9bc6-e62c53069d63 0093-5207 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20070511 ANDA ANDA076745 TEVA Pharmaceuticals USA Inc OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0093-5208_39a9c6f5-f8ab-4346-9bc6-e62c53069d63 0093-5208 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20061110 ANDA ANDA076745 TEVA Pharmaceuticals USA Inc OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0093-5213_9f894c04-4cf7-4de0-86f9-1d61027aa0ba 0093-5213 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20070307 ANDA ANDA076980 Teva Pharmaceuticals USA, Inc. MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 7.5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-5214_9f894c04-4cf7-4de0-86f9-1d61027aa0ba 0093-5214 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20070307 ANDA ANDA076980 Teva Pharmaceuticals USA, Inc. MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 15; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-5215_9f894c04-4cf7-4de0-86f9-1d61027aa0ba 0093-5215 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20070307 ANDA ANDA076980 Teva Pharmaceuticals USA, Inc. MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 15; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-5245_7d048537-c023-45e7-ae54-351b81f878c2 0093-5245 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120217 ANDA ANDA077243 Teva Pharmaceuticals USA, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-5246_7d048537-c023-45e7-ae54-351b81f878c2 0093-5246 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120217 ANDA ANDA077243 Teva Pharmaceuticals USA, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-5247_7d048537-c023-45e7-ae54-351b81f878c2 0093-5247 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120124 ANDA ANDA077243 Teva Pharmaceuticals USA, Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-5248_7d048537-c023-45e7-ae54-351b81f878c2 0093-5248 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120124 ANDA ANDA077243 Teva Pharmaceuticals USA, Inc. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-5260_3ab14e75-ff9a-498c-9462-fe009a1d5be7 0093-5260 HUMAN PRESCRIPTION DRUG Almotriptan Malate Almotriptan Malate TABLET, FILM COATED ORAL 20150707 ANDA ANDA078027 Teva Pharmaceuticals USA, Inc. ALMOTRIPTAN MALATE 6.25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0093-5261_3ab14e75-ff9a-498c-9462-fe009a1d5be7 0093-5261 HUMAN PRESCRIPTION DRUG Almotriptan Malate Almotriptan Malate TABLET, FILM COATED ORAL 20150707 ANDA ANDA078027 Teva Pharmaceuticals USA, Inc. ALMOTRIPTAN MALATE 12.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0093-5268_29809489-6821-461c-aa9d-35ef1626d9bf 0093-5268 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077239 Teva Pharmaceuticals USA Inc ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 0093-5269_29809489-6821-461c-aa9d-35ef1626d9bf 0093-5269 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077239 Teva Pharmaceuticals USA Inc ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 0093-5270_4bc2d76a-4672-46b4-8a32-6cc5f8886d01 0093-5270 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20040601 ANDA ANDA075644 Teva Pharmaceuticals USA Inc BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 0093-5271_4bc2d76a-4672-46b4-8a32-6cc5f8886d01 0093-5271 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20040601 ANDA ANDA075644 Teva Pharmaceuticals USA Inc BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 0093-5275_46e55d2b-8a15-4916-8fc8-b520c3ece570 0093-5275 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20070608 ANDA ANDA077107 Teva Pharmaceuticals USA, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5276_46e55d2b-8a15-4916-8fc8-b520c3ece570 0093-5276 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20070608 ANDA ANDA077107 Teva Pharmaceuticals USA, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5277_46e55d2b-8a15-4916-8fc8-b520c3ece570 0093-5277 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20070608 ANDA ANDA077107 Teva Pharmaceuticals USA, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5289_e7a6cebc-d4d3-43fe-a01d-c17eb7d27923 0093-5289 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20120601 ANDA ANDA091658 Teva Pharmaceuticals USA, Inc. VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0093-5290_e7a6cebc-d4d3-43fe-a01d-c17eb7d27923 0093-5290 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20120601 ANDA ANDA091658 Teva Pharmaceuticals USA, Inc. VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0093-5292_ff86fda6-283a-46df-a860-2cd60c20d8d8 0093-5292 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120927 ANDA ANDA078873 Teva Pharmaceuticals USA, Inc. METHYLPHENIDATE HYDROCHLORIDE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5293_ff86fda6-283a-46df-a860-2cd60c20d8d8 0093-5293 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120927 ANDA ANDA078873 Teva Pharmaceuticals USA, Inc. METHYLPHENIDATE HYDROCHLORIDE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5294_d38243f7-f7cd-44d7-a80d-b7594d1fa873 0093-5294 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20170808 ANDA ANDA204661 Teva Pharmaceuticals USA, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0093-5295_ff86fda6-283a-46df-a860-2cd60c20d8d8 0093-5295 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120927 ANDA ANDA077707 Teva Pharmaceuticals USA, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5296_ff86fda6-283a-46df-a860-2cd60c20d8d8 0093-5296 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120927 ANDA ANDA077707 Teva Pharmaceuticals USA, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5297_ff86fda6-283a-46df-a860-2cd60c20d8d8 0093-5297 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120927 ANDA ANDA077707 Teva Pharmaceuticals USA, Inc. METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5298_ff86fda6-283a-46df-a860-2cd60c20d8d8 0093-5298 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120927 ANDA ANDA078873 Teva Pharmaceuticals USA, Inc. METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5328_8daed458-5cdc-4cec-a066-c6cb7df44478 0093-5328 HUMAN PRESCRIPTION DRUG Junel Fe 24 Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20150608 ANDA ANDA090938 Teva Pharmaceuticals USA, Inc. N 20191231 0093-5341_0416469c-d0fa-489a-a35b-861092221582 0093-5341 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20171211 ANDA ANDA077342 Teva Pharmaceuticals USA, Inc. SILDENAFIL CITRATE 25 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 0093-5342_0416469c-d0fa-489a-a35b-861092221582 0093-5342 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20171211 ANDA ANDA077342 Teva Pharmaceuticals USA, Inc. SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 0093-5343_0416469c-d0fa-489a-a35b-861092221582 0093-5343 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20171211 ANDA ANDA077342 Teva Pharmaceuticals USA, Inc. SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 0093-5346_d832d0b0-bd3d-443b-a50f-8aa9ba649846 0093-5346 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (LA) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120716 ANDA ANDA079031 Teva Pharmaceuticals USA, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5347_d832d0b0-bd3d-443b-a50f-8aa9ba649846 0093-5347 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (LA) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120716 ANDA ANDA079031 Teva Pharmaceuticals USA, Inc. METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5348_d832d0b0-bd3d-443b-a50f-8aa9ba649846 0093-5348 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (LA) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120716 ANDA ANDA079031 Teva Pharmaceuticals USA, Inc. METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5352_7e89f81b-b44a-4906-bf01-785a94af3e0f 0093-5352 HUMAN PRESCRIPTION DRUG Acamprosate Calcium Acamprosate Calcium TABLET, DELAYED RELEASE ORAL 20160325 ANDA ANDA200143 Teva Pharmaceuticals USA, Inc. ACAMPROSATE CALCIUM 333 mg/1 N 20181231 0093-5353_9ae34d93-db17-4bac-8b4f-1445c6b25871 0093-5353 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE, LIQUID FILLED ORAL 20120301 ANDA ANDA202121 Teva Pharmaceuticals USA, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 0093-5354_9ae34d93-db17-4bac-8b4f-1445c6b25871 0093-5354 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE, LIQUID FILLED ORAL 20120301 ANDA ANDA202121 Teva Pharmaceuticals USA, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 0093-5378_a3dccdda-31a8-4b5c-a91b-62cc17473427 0093-5378 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine TABLET SUBLINGUAL 20100525 ANDA ANDA090360 Teva Pharmaceuticals USA, Inc. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 0093-5379_a3dccdda-31a8-4b5c-a91b-62cc17473427 0093-5379 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine TABLET SUBLINGUAL 20100525 ANDA ANDA090360 Teva Pharmaceuticals USA, Inc. BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 0093-5382_4ca540e7-006f-447b-8a19-263b63ecdb94 0093-5382 HUMAN PRESCRIPTION DRUG Abacavir and Lamivudine Abacavir and Lamivudine TABLET, FILM COATED ORAL 20160929 ANDA ANDA079246 Teva Pharmaceuticals USA, Inc. ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0093-5385_23322e2c-9a94-4c78-b650-148bfc6ba37b 0093-5385 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20111227 ANDA ANDA079081 Teva Pharmaceuticals USA, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0093-5401_dcecb0ef-e357-4af4-83e2-5b99723f8530 0093-5401 HUMAN PRESCRIPTION DRUG Omega-3-Acid Ethyl Esters Omega-3-Acid Ethyl Esters CAPSULE, LIQUID FILLED ORAL 20140407 ANDA ANDA091028 Teva Pharmaceuticals USA Inc OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 0093-5414_54a6695b-4502-4454-b56e-653ecd0f3233 0093-5414 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20080922 ANDA ANDA077523 Teva Pharmaceuticals USA Inc FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0093-5415_54a6695b-4502-4454-b56e-653ecd0f3233 0093-5415 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20080922 ANDA ANDA077523 Teva Pharmaceuticals USA Inc FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0093-5417_f5c0b98b-898d-4a23-9e48-904f2b844dd1 0093-5417 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET, ORALLY DISINTEGRATING ORAL 20170725 ANDA ANDA090308 Teva Pharmaceuticals USA, Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-5419_f5c0b98b-898d-4a23-9e48-904f2b844dd1 0093-5419 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET, ORALLY DISINTEGRATING ORAL 20170725 ANDA ANDA090308 Teva Pharmaceuticals USA, Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-5420_bd7797e1-c1b4-43ef-8e1f-bbbd76da0a63 0093-5420 HUMAN PRESCRIPTION DRUG Cabergoline Cabergoline TABLET ORAL 20070307 ANDA ANDA077750 Teva Pharmaceuticals USA Inc CABERGOLINE .5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 0093-5423_67ed8834-01e8-4ac4-87cf-a8f07104454f 0093-5423 HUMAN PRESCRIPTION DRUG Gianvi Drospirenone and ethinyl estradiol KIT 20110330 NDA AUTHORIZED GENERIC NDA021676 Teva Pharmaceuticals USA Inc N 20181231 0093-5454_3d910f1f-67df-4eb9-98b1-9003e3f655be 0093-5454 HUMAN PRESCRIPTION DRUG Mimvey Lo Estradiol and Norethindrone Acetate TABLET ORAL 20140602 ANDA ANDA200747 Teva Pharmaceuticals USA, Inc. ESTRADIOL; NORETHINDRONE ACETATE .5; .1 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0093-5455_3d910f1f-67df-4eb9-98b1-9003e3f655be 0093-5455 HUMAN PRESCRIPTION DRUG Mimvey Estradiol and Norethindrone Acetate TABLET, FILM COATED ORAL 20100602 ANDA ANDA079193 Teva Pharmaceuticals USA, Inc. ESTRADIOL; NORETHINDRONE ACETATE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0093-5503_8962613f-330a-480c-b545-5c2759262880 0093-5503 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20130410 ANDA ANDA202074 Teva Pharmaceuticals USA, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 3; 25 mg/1; mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Atypical Antipsychotic [EPC] N 20181231 0093-5504_8962613f-330a-480c-b545-5c2759262880 0093-5504 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20120619 ANDA ANDA077528 Teva Pharmaceuticals USA, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 6; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-5505_8962613f-330a-480c-b545-5c2759262880 0093-5505 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20120619 ANDA ANDA077528 Teva Pharmaceuticals USA, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 6; 50 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-5506_8962613f-330a-480c-b545-5c2759262880 0093-5506 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20120619 ANDA ANDA077528 Teva Pharmaceuticals USA, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 12; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-5507_8962613f-330a-480c-b545-5c2759262880 0093-5507 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20120619 ANDA ANDA077528 Teva Pharmaceuticals USA, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 12; 50 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-5509_584991fa-6d03-4bd7-8094-dbf6de3e6233 0093-5509 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, DELAYED RELEASE ORAL 20150518 ANDA ANDA203217 Teva Pharmaceuticals USA Inc RISEDRONATE SODIUM MONOHYDRATE 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0093-5512_9af71753-5b23-4dbd-bbf6-fadac9145362 0093-5512 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20130715 ANDA ANDA078592 Teva Pharmaceuticals USA Inc CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0093-5513_9af71753-5b23-4dbd-bbf6-fadac9145362 0093-5513 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20130211 ANDA ANDA078592 Teva Pharmaceuticals USA Inc CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0093-5514_9af71753-5b23-4dbd-bbf6-fadac9145362 0093-5514 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20130211 ANDA ANDA078592 Teva Pharmaceuticals USA Inc CARBAMAZEPINE 300 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0093-5517_743d1ebd-293c-4c66-9be2-d570eb3f4d2b 0093-5517 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20130531 ANDA ANDA078380 Teva Pharmaceuticals USA, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0093-5526_64384034-e36d-47e0-b10c-e6e8ca871043 0093-5526 HUMAN PRESCRIPTION DRUG Atazanavir Sulfate Atazanavir Sulfate CAPSULE ORAL 20171227 ANDA ANDA091673 Teva Pharmaceuticals USA, Inc. ATAZANAVIR SULFATE 150 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 0093-5527_64384034-e36d-47e0-b10c-e6e8ca871043 0093-5527 HUMAN PRESCRIPTION DRUG Atazanavir Sulfate Atazanavir Sulfate CAPSULE ORAL 20171227 ANDA ANDA091673 Teva Pharmaceuticals USA, Inc. ATAZANAVIR SULFATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 0093-5528_64384034-e36d-47e0-b10c-e6e8ca871043 0093-5528 HUMAN PRESCRIPTION DRUG Atazanavir Sulfate Atazanavir Sulfate CAPSULE ORAL 20171227 ANDA ANDA091673 Teva Pharmaceuticals USA, Inc. ATAZANAVIR SULFATE 300 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 0093-5537_c12ae6e0-1038-4ed0-a089-819e850cdb20 0093-5537 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140414 ANDA ANDA091169 Teva Pharmaceuticals USA, Inc. ESZOPICLONE 1 mg/1 CIV N 20181231 0093-5538_c12ae6e0-1038-4ed0-a089-819e850cdb20 0093-5538 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140414 ANDA ANDA091169 Teva Pharmaceuticals USA, Inc. ESZOPICLONE 2 mg/1 CIV N 20181231 0093-5539_c12ae6e0-1038-4ed0-a089-819e850cdb20 0093-5539 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140414 ANDA ANDA091169 Teva Pharmaceuticals USA, Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 0093-5550_bf59fedb-4d5c-41d4-b652-f55e813f5c27 0093-5550 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141110 ANDA ANDA078908 Teva Pharmaceuticals USA, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5551_bf59fedb-4d5c-41d4-b652-f55e813f5c27 0093-5551 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150202 ANDA ANDA078908 Teva Pharmaceuticals USA, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5552_bf59fedb-4d5c-41d4-b652-f55e813f5c27 0093-5552 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140521 ANDA ANDA078908 Teva Pharmaceuticals USA, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5553_bf59fedb-4d5c-41d4-b652-f55e813f5c27 0093-5553 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150622 ANDA ANDA078908 Teva Pharmaceuticals USA, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5554_bf59fedb-4d5c-41d4-b652-f55e813f5c27 0093-5554 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140522 ANDA ANDA202731 Teva Pharmaceuticals USA, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5562_bf59fedb-4d5c-41d4-b652-f55e813f5c27 0093-5562 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20131121 ANDA ANDA202731 Teva Pharmaceuticals USA, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0093-5655_86f2742d-47b5-429a-8b5f-f9ece33bde3a 0093-5655 HUMAN PRESCRIPTION DRUG Dutasteride Dutasteride CAPSULE, LIQUID FILLED ORAL 20151009 ANDA ANDA090095 Teva Pharmaceuticals USA Inc DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 0093-5720_97497f37-0596-4f0f-b3aa-09c098eaada5 0093-5720 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone Buprenorphine and Naloxone TABLET SUBLINGUAL 20141210 20181031 ANDA ANDA091149 Teva Pharmaceuticals USA, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 0093-5721_97497f37-0596-4f0f-b3aa-09c098eaada5 0093-5721 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone Buprenorphine and Naloxone TABLET SUBLINGUAL 20141210 20181031 ANDA ANDA091149 Teva Pharmaceuticals USA, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 0093-5731_42472424-c9cb-4205-85bd-bf9d8a0f0e0c 0093-5731 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151012 NDA AUTHORIZED GENERIC NDA022272 Teva Pharmaceuticals USA, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0093-5732_42472424-c9cb-4205-85bd-bf9d8a0f0e0c 0093-5732 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151012 NDA AUTHORIZED GENERIC NDA022272 Teva Pharmaceuticals USA, Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0093-5733_42472424-c9cb-4205-85bd-bf9d8a0f0e0c 0093-5733 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151014 NDA AUTHORIZED GENERIC NDA022272 Teva Pharmaceuticals USA, Inc. OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0093-5734_42472424-c9cb-4205-85bd-bf9d8a0f0e0c 0093-5734 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151014 NDA AUTHORIZED GENERIC NDA022272 Teva Pharmaceuticals USA, Inc. OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0093-5740_c6858d6c-2773-4d8d-a08c-19d69d2f67cb 0093-5740 HUMAN PRESCRIPTION DRUG Cyclosporine Modified Cyclosporine CAPSULE, LIQUID FILLED ORAL 20150601 ANDA ANDA065110 Teva Pharmaceuticals USA Inc CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0093-5741_c6858d6c-2773-4d8d-a08c-19d69d2f67cb 0093-5741 HUMAN PRESCRIPTION DRUG Cyclosporine Modified Cyclosporine CAPSULE, LIQUID FILLED ORAL 20150601 ANDA ANDA065110 Teva Pharmaceuticals USA Inc CYCLOSPORINE 50 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0093-5742_c6858d6c-2773-4d8d-a08c-19d69d2f67cb 0093-5742 HUMAN PRESCRIPTION DRUG Cyclosporine Modified Cyclosporine CAPSULE, LIQUID FILLED ORAL 20150601 ANDA ANDA065110 Teva Pharmaceuticals USA Inc CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0093-5767_c0d9b234-d386-4208-97bf-cd9f62e31902 0093-5767 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Teva Pharmaceuticals USA, Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-5768_c0d9b234-d386-4208-97bf-cd9f62e31902 0093-5768 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Teva Pharmaceuticals USA, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-5769_c0d9b234-d386-4208-97bf-cd9f62e31902 0093-5769 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Teva Pharmaceuticals USA, Inc. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-5770_c0d9b234-d386-4208-97bf-cd9f62e31902 0093-5770 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Teva Pharmaceuticals USA, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-5771_c0d9b234-d386-4208-97bf-cd9f62e31902 0093-5771 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Teva Pharmaceuticals USA, Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-5786_c20b87d8-903a-421c-9644-75f36e6cb96c 0093-5786 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20140904 ANDA ANDA202122 Teva Pharmaceuticals USA, Inc. ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0093-5787_c20b87d8-903a-421c-9644-75f36e6cb96c 0093-5787 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20140904 ANDA ANDA202122 Teva Pharmaceuticals USA, Inc. ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0093-5850_fc163a34-2bcb-497b-a876-f79d645a8d18 0093-5850 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Teva Pharmaceuticals USA, Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-5851_fc163a34-2bcb-497b-a876-f79d645a8d18 0093-5851 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Teva Pharmaceuticals USA, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-5852_fc163a34-2bcb-497b-a876-f79d645a8d18 0093-5852 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Teva Pharmaceuticals USA, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-5861_bb9309e5-da52-460a-b95c-041c47a962d5 0093-5861 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20130411 ANDA ANDA091443 Teva Pharmaceuticals USA, Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0093-5862_bb9309e5-da52-460a-b95c-041c47a962d5 0093-5862 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20130411 ANDA ANDA091443 Teva Pharmaceuticals USA, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0093-5960_5ad1e8ee-36b4-4264-a7d5-a34a023aab93 0093-5960 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET, EXTENDED RELEASE ORAL 20150602 ANDA ANDA201382 Teva Pharmaceuticals USA, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0093-5961_5ad1e8ee-36b4-4264-a7d5-a34a023aab93 0093-5961 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET, EXTENDED RELEASE ORAL 20150602 ANDA ANDA201382 Teva Pharmaceuticals USA, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0093-5963_5ad1e8ee-36b4-4264-a7d5-a34a023aab93 0093-5963 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET, EXTENDED RELEASE ORAL 20150602 ANDA ANDA201382 Teva Pharmaceuticals USA, Inc. GUANFACINE HYDROCHLORIDE 3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0093-5964_5ad1e8ee-36b4-4264-a7d5-a34a023aab93 0093-5964 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET, EXTENDED RELEASE ORAL 20150602 ANDA ANDA201382 Teva Pharmaceuticals USA, Inc. GUANFACINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0093-6031_01be5767-8fbe-4d4e-af0d-5af38bacfee3 0093-6031 HUMAN PRESCRIPTION DRUG Rivelsa Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20170403 NDA AUTHORIZED GENERIC NDA204061 Teva Pharmaceuticals USA, Inc. N 20181231 0093-6108_36379ede-9bb6-4685-821d-34f91af262ee 0093-6108 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine SOLUTION ORAL 20010802 ANDA ANDA075506 Teva Pharmaceuticals USA, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-6118_51806556-6892-450f-911c-84182e9e34a7 0093-6118 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 19981211 20180228 ANDA ANDA089081 Teva Pharmaceuticals USA, Inc. PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0093-6137_b64e8da7-2774-4a15-894f-d88a181730b9 0093-6137 HUMAN PRESCRIPTION DRUG Diazepam Diazepam GEL RECTAL 20101001 NDA AUTHORIZED GENERIC NDA020648 Teva Pharmaceuticals USA Inc DIAZEPAM 2.5 mg/.5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0093-6138_b64e8da7-2774-4a15-894f-d88a181730b9 0093-6138 HUMAN PRESCRIPTION DRUG Diazepam Diazepam GEL RECTAL 20100903 NDA AUTHORIZED GENERIC NDA020648 Teva Pharmaceuticals USA Inc DIAZEPAM 10 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0093-6139_b64e8da7-2774-4a15-894f-d88a181730b9 0093-6139 HUMAN PRESCRIPTION DRUG Diazepam Diazepam GEL RECTAL 20100903 NDA AUTHORIZED GENERIC NDA020648 Teva Pharmaceuticals USA Inc DIAZEPAM 20 mg/4mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0093-6148_54828ddb-070a-4dbe-b359-19d3a38b83e2 0093-6148 HUMAN PRESCRIPTION DRUG camrese Lo Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20111207 NDA AUTHORIZED GENERIC NDA022262 Teva Pharmaceuticals USA, Inc. N 20181231 0093-6301_7538f1e1-5e5d-458a-acbc-a6b389157339 0093-6301 HUMAN PRESCRIPTION DRUG Adapalene Adapalene GEL TOPICAL 20100602 ANDA ANDA090962 Teva Pharmaceuticals USA, Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0093-6450_2cf216d6-6db5-4547-be9e-8f9328e411ac 0093-6450 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20150217 ANDA ANDA078003 Teva Pharmaceuticals USA, Inc. ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0093-6451_2cf216d6-6db5-4547-be9e-8f9328e411ac 0093-6451 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20150217 ANDA ANDA078003 Teva Pharmaceuticals USA, Inc. ESOMEPRAZOLE MAGNESIUM DIHYDRATE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0093-6723_d1350853-c712-4bf6-b426-c4fa06f5295d 0093-6723 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20080102 ANDA ANDA076724 Teva Pharmaceuticals USA Inc IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 2.5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0093-6815_0fc23664-639c-4cf1-a074-9604e48ca0be 0093-6815 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20081119 ANDA ANDA077519 Teva Pharmaceuticals USA, Inc. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0093-6816_0fc23664-639c-4cf1-a074-9604e48ca0be 0093-6816 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20081119 ANDA ANDA077519 Teva Pharmaceuticals USA, Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0093-6817_9c89fa91-9215-4c76-b607-7445b6495f30 0093-6817 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20160311 ANDA ANDA204548 Teva Pharmaceuticals USA, Inc. BUDESONIDE 1 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0093-7027_3b18a381-fcf6-492b-9c08-9ec060b43493 0093-7027 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20161026 ANDA ANDA091154 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7028_3b18a381-fcf6-492b-9c08-9ec060b43493 0093-7028 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20161026 ANDA ANDA091154 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7029_3b18a381-fcf6-492b-9c08-9ec060b43493 0093-7029 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20161026 ANDA ANDA091154 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7030_3b18a381-fcf6-492b-9c08-9ec060b43493 0093-7030 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20161026 ANDA ANDA091154 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7037_b49078fe-51c0-46bf-b38b-399c6c6aaa45 0093-7037 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan, and Hydrochlorothiazide Amlodipine, Valsartan, and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 ANDA ANDA200435 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-7038_b49078fe-51c0-46bf-b38b-399c6c6aaa45 0093-7038 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan, and Hydrochlorothiazide Amlodipine, Valsartan, and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 ANDA ANDA200435 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-7104_c1eb87e2-7a44-4564-9215-ae966ee2319c 0093-7104 HUMAN PRESCRIPTION DRUG Tenofovir Disoproxil Fumarate Tenofovir Disoproxil Fumarate TABLET, FILM COATED ORAL 20171215 ANDA ANDA091612 Teva Pharmaceuticals USA, Inc. TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0093-7113_9d324986-7cd7-4e49-8651-11aad2df633d 0093-7113 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Teva Pharmaceuticals USA Inc NEFAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 0093-7146_a51a04f1-1c7e-4b6c-ab59-cc50f2567a48 0093-7146 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065153 Teva Pharmaceuticals USA, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0093-7147_6bb55b3a-1790-426e-9a68-f5fd0f0d4d62 0093-7147 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065150 Teva Pharmaceuticals USA, Inc. AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0093-7148_98f701e6-6825-4360-8cdb-6d91f5962a75 0093-7148 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin Monohydrate POWDER, FOR SUSPENSION ORAL 20080922 ANDA ANDA065419 Teva Pharmaceuticals USA, Inc. AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0093-7149_98f701e6-6825-4360-8cdb-6d91f5962a75 0093-7149 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin Monohydrate POWDER, FOR SUSPENSION ORAL 20080922 ANDA ANDA065419 Teva Pharmaceuticals USA, Inc. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0093-7152_f2c69260-85d9-442e-8154-eab095a13418 0093-7152 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 Teva Pharmaceuticals USA Inc SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7153_f46752d2-20d8-4919-af9b-293c5a9d63d2 0093-7153 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 Teva Pharmaceuticals USA, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7154_f46752d2-20d8-4919-af9b-293c5a9d63d2 0093-7154 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 Teva Pharmaceuticals USA, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7155_f46752d2-20d8-4919-af9b-293c5a9d63d2 0093-7155 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 Teva Pharmaceuticals USA, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7156_f46752d2-20d8-4919-af9b-293c5a9d63d2 0093-7156 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA076052 Teva Pharmaceuticals USA, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7163_0e478109-3861-4003-bce5-766f18cb959b 0093-7163 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20170320 ANDA ANDA079141 Teva Pharmaceuticals USA, Inc. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0093-7164_0e478109-3861-4003-bce5-766f18cb959b 0093-7164 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20170320 ANDA ANDA079141 Teva Pharmaceuticals USA, Inc. TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0093-7165_729b945c-268b-437f-a865-48b9002919d3 0093-7165 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 Teva Pharmaceuticals USA Inc CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-7166_729b945c-268b-437f-a865-48b9002919d3 0093-7166 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 Teva Pharmaceuticals USA Inc CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-7167_019c5d51-b8bc-4bcb-8244-4ca7fca0f208 0093-7167 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070710 ANDA ANDA076846 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0093-7168_33a1eaef-d136-4886-978a-2c1dd3570985 0093-7168 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070710 ANDA ANDA076846 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0093-7169_a51a04f1-1c7e-4b6c-ab59-cc50f2567a48 0093-7169 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065193 Teva Pharmaceuticals USA, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0093-7170_729b945c-268b-437f-a865-48b9002919d3 0093-7170 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 Teva Pharmaceuticals USA Inc CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-7172_9ff91524-5bb6-40f5-823f-dbbe6a01d195 0093-7172 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000811 ANDA ANDA075665 Teva Pharmaceuticals USA , Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-7178_9d324986-7cd7-4e49-8651-11aad2df633d 0093-7178 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Teva Pharmaceuticals USA Inc NEFAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 0093-7188_9f631744-b579-49a1-856e-3c3c24dda6c8 0093-7188 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine TABLET, FILM COATED ORAL 20020130 ANDA ANDA075872 Teva Pharmaceuticals USA, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-7198_1e1b1763-826f-4842-b3c7-9331a3b006b5 0093-7198 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020130 ANDA ANDA075452 Teva Pharmaceuticals USA, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-7201_e425e48c-1a6d-42f3-ae8e-03743dbe4e33 0093-7201 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 Teva Pharmaceuticals USA Inc PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7202_e425e48c-1a6d-42f3-ae8e-03743dbe4e33 0093-7202 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 Teva Pharmaceuticals USA Inc PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7206_f175ee56-eb71-4f46-b0c5-05b0a69148b5 0093-7206 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030129 ANDA ANDA076119 Teva Pharmaceuticals USA, Inc. MIRTAZAPINE 15 mg/1 N 20181231 0093-7207_f175ee56-eb71-4f46-b0c5-05b0a69148b5 0093-7207 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030129 ANDA ANDA076119 Teva Pharmaceuticals USA, Inc. MIRTAZAPINE 30 mg/1 N 20181231 0093-7208_f175ee56-eb71-4f46-b0c5-05b0a69148b5 0093-7208 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076119 Teva Pharmaceuticals USA, Inc. MIRTAZAPINE 45 mg/1 N 20181231 0093-7212_c2be1eda-2461-4dec-98f2-5ef92024a58e 0093-7212 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20050413 ANDA ANDA076864 Teva Pharmaceuticals USA, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0093-7214_abe5ba83-2130-4af4-afd1-0ce279140459 0093-7214 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20030417 ANDA ANDA075978 Teva Pharmaceuticals USA, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0093-7222_9e947fa4-930b-4a79-8f1d-f90c12a7fbc5 0093-7222 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20031201 ANDA ANDA076139 Teva Pharmaceuticals USA, Inc. FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0093-7223_9e947fa4-930b-4a79-8f1d-f90c12a7fbc5 0093-7223 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20031201 ANDA ANDA076139 Teva Pharmaceuticals USA, Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0093-7224_9e947fa4-930b-4a79-8f1d-f90c12a7fbc5 0093-7224 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20031201 ANDA ANDA076139 Teva Pharmaceuticals USA, Inc. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0093-7247_1f42e295-fa94-49b7-ae9f-abf51f4946f2 0093-7247 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080722 ANDA ANDA076388 Teva Pharmaceuticals USA, Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0093-7248_1f42e295-fa94-49b7-ae9f-abf51f4946f2 0093-7248 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080722 ANDA ANDA076388 Teva Pharmaceuticals USA, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0093-7254_23292697-3507-4daa-9687-028ab1c905f7 0093-7254 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA076802 Teva Pharmaceuticals USA, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0093-7255_23292697-3507-4daa-9687-028ab1c905f7 0093-7255 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA076802 Teva Pharmaceuticals USA, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0093-7256_23292697-3507-4daa-9687-028ab1c905f7 0093-7256 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA076802 Teva Pharmaceuticals USA, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0093-7258_36275ad8-ba45-4707-ac52-637942dde50b 0093-7258 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20100524 ANDA ANDA077655 Teva Pharmaceuticals USA Inc VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0093-7259_36275ad8-ba45-4707-ac52-637942dde50b 0093-7259 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20100524 ANDA ANDA077655 Teva Pharmaceuticals USA Inc VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0093-7267_c2be1eda-2461-4dec-98f2-5ef92024a58e 0093-7267 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040618 ANDA ANDA076269 Teva Pharmaceuticals USA, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0093-7270_e425e48c-1a6d-42f3-ae8e-03743dbe4e33 0093-7270 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20080929 ANDA ANDA077793 Teva Pharmaceuticals USA Inc PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7271_bb9a29cd-d2c9-4c58-a9d0-8039d8711fde 0093-7271 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20150204 ANDA ANDA077210 Teva Pharmaceuticals USA, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 0093-7272_bb9a29cd-d2c9-4c58-a9d0-8039d8711fde 0093-7272 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20150204 ANDA ANDA077210 Teva Pharmaceuticals USA, Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 0093-7273_bb9a29cd-d2c9-4c58-a9d0-8039d8711fde 0093-7273 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20150522 ANDA ANDA077210 Teva Pharmaceuticals USA, Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 0093-7290_c2afd05f-bff6-4053-bbfa-5fd25f122463 0093-7290 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20140328 ANDA ANDA078193 Teva Pharmaceuticals USA, Inc. RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0093-7295_d80d00c4-d31c-4683-ada4-435aa4d54b3d 0093-7295 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA076373 Teva Pharmaceuticals USA, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0093-7296_d80d00c4-d31c-4683-ada4-435aa4d54b3d 0093-7296 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA076373 Teva Pharmaceuticals USA, Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0093-7303_b4cc1f54-2b0d-42c4-b6a6-500417093e2d 0093-7303 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20050901 20180331 ANDA ANDA076901 Teva Pharmaceuticals USA, Inc. MIRTAZAPINE 15 mg/1 N 20181231 0093-7304_b4cc1f54-2b0d-42c4-b6a6-500417093e2d 0093-7304 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20050901 20180331 ANDA ANDA076901 Teva Pharmaceuticals USA, Inc. MIRTAZAPINE 30 mg/1 N 20181231 0093-7305_b4cc1f54-2b0d-42c4-b6a6-500417093e2d 0093-7305 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20050901 20180531 ANDA ANDA076901 Teva Pharmaceuticals USA, Inc. MIRTAZAPINE 45 mg/1 N 20181231 0093-7306_729b945c-268b-437f-a865-48b9002919d3 0093-7306 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 Teva Pharmaceuticals USA Inc CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0093-7314_28633b81-22de-430e-a5ab-4c8afaa28523 0093-7314 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA076999 Teva Pharmaceuticals USA, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20191231 0093-7334_e340522c-30cf-4307-a946-cb96c89f1434 0093-7334 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20090506 ANDA ANDA065491 Teva Pharmaceuticals USA, Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 0093-7335_f7739bad-869e-4b1d-b20a-520ffabe94c2 0093-7335 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, COATED PELLETS ORAL 20090417 ANDA ANDA076575 Teva Pharmaceuticals USA, Inc. TOPIRAMATE 15 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0093-7336_f7739bad-869e-4b1d-b20a-520ffabe94c2 0093-7336 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, COATED PELLETS ORAL 20090417 ANDA ANDA076575 Teva Pharmaceuticals USA, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0093-7350_6cfc74cf-e4e3-4402-aceb-f8aa99c210bb 0093-7350 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 ANDA ANDA077255 Teva Pharmaceuticals USA, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 0093-7351_6cfc74cf-e4e3-4402-aceb-f8aa99c210bb 0093-7351 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 ANDA ANDA077255 Teva Pharmaceuticals USA, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 0093-7352_3efe6dad-c87a-4f33-bfff-ba26378e96e0 0093-7352 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20160825 ANDA ANDA075765 Teva Pharmaceuticals USA, Inc. CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0093-7353_3efe6dad-c87a-4f33-bfff-ba26378e96e0 0093-7353 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20160701 ANDA ANDA075765 Teva Pharmaceuticals USA, Inc. CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0093-7355_cfbfb418-8c56-4140-80b7-af51ce5a14eb 0093-7355 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20061215 ANDA ANDA076511 Teva Pharmaceuticals USA, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 0093-7364_363c62af-7dce-42f3-bf07-22f6c5c18d19 0093-7364 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Teva Pharmaceuticals USA ,Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7365_363c62af-7dce-42f3-bf07-22f6c5c18d19 0093-7365 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Teva Pharmaceuticals USA ,Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7366_363c62af-7dce-42f3-bf07-22f6c5c18d19 0093-7366 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Teva Pharmaceuticals USA ,Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7367_9e54096f-0791-43d7-b036-480e05734b4d 0093-7367 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Teva Pharmaceuticals USA, Inc LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-7368_9e54096f-0791-43d7-b036-480e05734b4d 0093-7368 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Teva Pharmaceuticals USA, Inc LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-7369_9e54096f-0791-43d7-b036-480e05734b4d 0093-7369 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Teva Pharmaceuticals USA, Inc LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-7370_a804a97e-d1e0-411b-b075-557ac09684c0 0093-7370 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20070518 ANDA ANDA077179 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-7371_a804a97e-d1e0-411b-b075-557ac09684c0 0093-7371 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20070518 ANDA ANDA077179 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-7372_a804a97e-d1e0-411b-b075-557ac09684c0 0093-7372 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20070518 ANDA ANDA077179 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-7373_a804a97e-d1e0-411b-b075-557ac09684c0 0093-7373 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20070518 ANDA ANDA077179 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-7380_d0f2507d-9287-4aca-b388-e73a4577781f 0093-7380 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Teva Pharmaceuticals USA, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-7381_d0f2507d-9287-4aca-b388-e73a4577781f 0093-7381 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Teva Pharmaceuticals USA, Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-7382_d0f2507d-9287-4aca-b388-e73a4577781f 0093-7382 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Teva Pharmaceuticals USA, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-7383_d0f2507d-9287-4aca-b388-e73a4577781f 0093-7383 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Teva Pharmaceuticals USA, Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0093-7384_4ef50c89-51e9-4f46-a391-42a2e1170ecd 0093-7384 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Teva Pharmaceuticals USA, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0093-7385_4ef50c89-51e9-4f46-a391-42a2e1170ecd 0093-7385 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Teva Pharmaceuticals USA, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0093-7386_4ef50c89-51e9-4f46-a391-42a2e1170ecd 0093-7386 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Teva Pharmaceuticals USA, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0093-7387_d1ad23f3-e255-4575-b011-a7c65b48534e 0093-7387 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET, FILM COATED ORAL 20140219 ANDA ANDA077437 Teva Pharmaceuticals USA, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0093-7392_c7f611eb-c099-4117-84f6-7df44f4b229a 0093-7392 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20130920 20181130 ANDA ANDA076378 Teva Pharmaceuticals USA, Inc. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 0093-7393_c7f611eb-c099-4117-84f6-7df44f4b229a 0093-7393 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20130920 20180930 ANDA ANDA076378 Teva Pharmaceuticals USA, Inc. NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 0093-7394_c7f611eb-c099-4117-84f6-7df44f4b229a 0093-7394 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20130920 20190131 ANDA ANDA076250 Teva Pharmaceuticals USA, Inc. NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 0093-7424_150b409b-5965-445f-be07-752089200dfd 0093-7424 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA078723 Teva Pharmaceuticals USA, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0093-7425_150b409b-5965-445f-be07-752089200dfd 0093-7425 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA078723 Teva Pharmaceuticals USA, Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0093-7426_150b409b-5965-445f-be07-752089200dfd 0093-7426 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA078605 Teva Pharmaceuticals USA, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0093-7439_b0415b79-5a2e-454c-baba-83f3d2e826a1 0093-7439 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA076941 Teva Pharmaceuticals USA, Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0093-7440_b0415b79-5a2e-454c-baba-83f3d2e826a1 0093-7440 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA076941 Teva Pharmaceuticals USA, Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0093-7441_b0415b79-5a2e-454c-baba-83f3d2e826a1 0093-7441 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA076941 Teva Pharmaceuticals USA, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0093-7442_713b46d1-f13c-414a-a30b-b7265913c886 0093-7442 HUMAN PRESCRIPTION DRUG Fluvastatin Fluvastatin CAPSULE ORAL 20120705 ANDA ANDA078407 Teva Pharmaceuticals USA, Inc. FLUVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7443_713b46d1-f13c-414a-a30b-b7265913c886 0093-7443 HUMAN PRESCRIPTION DRUG Fluvastatin Fluvastatin CAPSULE ORAL 20120705 ANDA ANDA078407 Teva Pharmaceuticals USA, Inc. FLUVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7445_320ac417-bcbc-4b36-9d14-894a7868f459 0093-7445 HUMAN PRESCRIPTION DRUG Budesonide (Enteric Coated) Budesonide CAPSULE, DELAYED RELEASE PELLETS ORAL 20160623 ANDA ANDA090379 Teva Pharmaceuticals USA, Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0093-7446_a4ec780a-dfd4-4116-a405-2de6e6626cc1 0093-7446 HUMAN PRESCRIPTION DRUG Fluvastatin Sodium Fluvastatin Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160602 ANDA ANDA079011 Teva Pharmaceuticals USA, Inc. FLUVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7455_302ae210-7009-40cb-a74f-e5b7100de7e1 0093-7455 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 Teva Pharmaceuticals USA, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0093-7456_302ae210-7009-40cb-a74f-e5b7100de7e1 0093-7456 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 Teva Pharmaceuticals USA, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0093-7457_302ae210-7009-40cb-a74f-e5b7100de7e1 0093-7457 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 Teva Pharmaceuticals USA, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0093-7471_a9baab80-2c8d-4176-abee-1dea226108de 0093-7471 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20130212 ANDA ANDA077263 Teva Pharmaceuticals USA, Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 0093-7472_a9baab80-2c8d-4176-abee-1dea226108de 0093-7472 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20130212 ANDA ANDA077263 Teva Pharmaceuticals USA, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 0093-7473_a7eb7948-b7dd-4a8f-8395-2c1e6660813e 0093-7473 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20140307 ANDA ANDA091649 Teva Pharmaceuticals USA, Inc. CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0093-7474_a7eb7948-b7dd-4a8f-8395-2c1e6660813e 0093-7474 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20140307 ANDA ANDA091649 Teva Pharmaceuticals USA, Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0093-7477_e340522c-30cf-4307-a946-cb96c89f1434 0093-7477 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET, FILM COATED ORAL 20090505 ANDA ANDA065457 Teva Pharmaceuticals USA, Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 0093-7485_17a34811-51c7-48bc-9d65-a7582bf27587 0093-7485 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET, FILM COATED ORAL 20080102 ANDA ANDA078080 Teva Pharmaceuticals USA Inc GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0093-7487_15ca16ae-35dd-42ec-b1af-9c1072ee6188 0093-7487 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium GRANULE ORAL 20171213 ANDA ANDA090955 Teva Pharmaceuticals USA, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0093-7490_ce6c1be9-627f-4652-91ea-15495d200e6f 0093-7490 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20160603 ANDA ANDA078061 Teva Pharmaceuticals USA, Inc. LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0093-7528_2216a9ad-d2a1-4ce9-bbb0-ede8d023e0f5 0093-7528 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20141216 ANDA ANDA065155 Teva Pharmaceuticals USA Inc CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0093-7529_2216a9ad-d2a1-4ce9-bbb0-ede8d023e0f5 0093-7529 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20141216 ANDA ANDA065155 Teva Pharmaceuticals USA Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0093-7536_6d000c35-4717-45f8-9495-bd2714552247 0093-7536 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20100628 ANDA ANDA078058 Teva Pharmaceuticals USA Inc ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0093-7542_52427dde-8944-4b3e-8a73-b0a67edd1339 0093-7542 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20131211 ANDA ANDA090783 Teva Pharmaceuticals USA, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0093-7543_52427dde-8944-4b3e-8a73-b0a67edd1339 0093-7543 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20131211 ANDA ANDA090783 Teva Pharmaceuticals USA, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0093-7544_52427dde-8944-4b3e-8a73-b0a67edd1339 0093-7544 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20131211 ANDA ANDA090783 Teva Pharmaceuticals USA, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0093-7569_8bceca31-f37f-4be7-aa50-723203e19243 0093-7569 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA078607 Teva Pharmaceuticals USA, Inc. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-7570_a89c7b88-0bb8-44fa-bfc5-fcbf17dd15af 0093-7570 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160818 ANDA ANDA079166 Teva Pharmaceuticals USA, Inc. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7571_a89c7b88-0bb8-44fa-bfc5-fcbf17dd15af 0093-7571 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160818 ANDA ANDA079166 Teva Pharmaceuticals USA, Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7572_a89c7b88-0bb8-44fa-bfc5-fcbf17dd15af 0093-7572 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160818 ANDA ANDA079166 Teva Pharmaceuticals USA, Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7573_a89c7b88-0bb8-44fa-bfc5-fcbf17dd15af 0093-7573 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160818 ANDA ANDA079166 Teva Pharmaceuticals USA, Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0093-7580_8bceca31-f37f-4be7-aa50-723203e19243 0093-7580 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA078608 Teva Pharmaceuticals USA, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-7581_8bceca31-f37f-4be7-aa50-723203e19243 0093-7581 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA078708 Teva Pharmaceuticals USA, Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-7582_8bceca31-f37f-4be7-aa50-723203e19243 0093-7582 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA078708 Teva Pharmaceuticals USA, Inc. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-7583_8bceca31-f37f-4be7-aa50-723203e19243 0093-7583 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA078708 Teva Pharmaceuticals USA, Inc. ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-7599_1ce6a298-fd5d-4252-bd35-3a5293978c87 0093-7599 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 ANDA ANDA078879 Teva Pharmaceuticals USA, Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0093-7600_1ce6a298-fd5d-4252-bd35-3a5293978c87 0093-7600 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 ANDA ANDA078879 Teva Pharmaceuticals USA, Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0093-7601_1ce6a298-fd5d-4252-bd35-3a5293978c87 0093-7601 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 ANDA ANDA078879 Teva Pharmaceuticals USA, Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0093-7602_1ce6a298-fd5d-4252-bd35-3a5293978c87 0093-7602 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 ANDA ANDA078879 Teva Pharmaceuticals USA, Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0093-7610_0b8af4dc-7ff5-4a99-b5f5-fb78dbfb8afe 0093-7610 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA091079 Teva Pharmaceuticals USA, Inc. OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7611_0b8af4dc-7ff5-4a99-b5f5-fb78dbfb8afe 0093-7611 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA091079 Teva Pharmaceuticals USA, Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7612_0b8af4dc-7ff5-4a99-b5f5-fb78dbfb8afe 0093-7612 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA091079 Teva Pharmaceuticals USA, Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7613_8bceca31-f37f-4be7-aa50-723203e19243 0093-7613 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA078607 Teva Pharmaceuticals USA, Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-7615_f3b39478-b4af-4dcd-9bca-8a56cadef0b5 0093-7615 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170424 ANDA ANDA200532 Teva Pharmaceuticals USA, Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-7616_f3b39478-b4af-4dcd-9bca-8a56cadef0b5 0093-7616 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170424 ANDA ANDA200532 Teva Pharmaceuticals USA, Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-7617_f3b39478-b4af-4dcd-9bca-8a56cadef0b5 0093-7617 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170424 ANDA ANDA200532 Teva Pharmaceuticals USA, Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-7618_cd5f9e1c-cf18-4e7a-ad49-d02e5b93a6c0 0093-7618 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride Dorzolamide Hydrochloride SOLUTION OPHTHALMIC 20100128 ANDA ANDA078756 Teva Pharmaceuticals USA, Inc. DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] N 20181231 0093-7620_8e095e67-6b98-477a-9ea0-63e99b14a730 0093-7620 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20110603 ANDA ANDA090289 Teva Pharmaceuticals USA Inc LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0093-7629_557f8728-9bf0-4ce9-be82-c706fcf68b13 0093-7629 HUMAN PRESCRIPTION DRUG Imatinib Mesylate Imatinib Mesylate TABLET, FILM COATED ORAL 20160804 ANDA ANDA204285 Teva Pharmaceuticals USA, Inc. IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 0093-7630_557f8728-9bf0-4ce9-be82-c706fcf68b13 0093-7630 HUMAN PRESCRIPTION DRUG Imatinib Mesylate Imatinib Mesylate TABLET, FILM COATED ORAL 20160804 ANDA ANDA204285 Teva Pharmaceuticals USA, Inc. IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 0093-7638_1ce6a298-fd5d-4252-bd35-3a5293978c87 0093-7638 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 ANDA ANDA078879 Teva Pharmaceuticals USA, Inc. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0093-7639_1ce6a298-fd5d-4252-bd35-3a5293978c87 0093-7639 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 ANDA ANDA078879 Teva Pharmaceuticals USA, Inc. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0093-7670_a804a97e-d1e0-411b-b075-557ac09684c0 0093-7670 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20110720 ANDA ANDA077179 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-7671_a804a97e-d1e0-411b-b075-557ac09684c0 0093-7671 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20110720 ANDA ANDA077179 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0093-7677_6d6e2f7a-bc12-415c-a191-869b40661a40 0093-7677 HUMAN PRESCRIPTION DRUG Pioglitazone and Metformin Hydrochloride Pioglitazone and Metformin Hydrochloride TABLET, FILM COATED ORAL 20150305 ANDA ANDA091155 Teva Pharmaceuticals USA, Inc. PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 500 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 0093-7678_6d6e2f7a-bc12-415c-a191-869b40661a40 0093-7678 HUMAN PRESCRIPTION DRUG Pioglitazone and Metformin Hydrochloride Pioglitazone and Metformin Hydrochloride TABLET, FILM COATED ORAL 20150204 ANDA ANDA091155 Teva Pharmaceuticals USA, Inc. PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 850 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 0093-7684_b0d146b9-9e8e-476a-bda6-75766b5526ca 0093-7684 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride Olopatadine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20170608 ANDA ANDA090848 Teva Pharmaceuticals USA, Inc. OLOPATADINE HYDROCHLORIDE 2 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 0093-7690_c08036de-d264-47b2-802e-d4776e1f8dcf 0093-7690 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET, FILM COATED ORAL 20150330 ANDA ANDA091235 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7691_c08036de-d264-47b2-802e-d4776e1f8dcf 0093-7691 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET, FILM COATED ORAL 20150330 ANDA ANDA091235 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7692_c08036de-d264-47b2-802e-d4776e1f8dcf 0093-7692 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET, FILM COATED ORAL 20150330 ANDA ANDA091235 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7693_c08036de-d264-47b2-802e-d4776e1f8dcf 0093-7693 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET, FILM COATED ORAL 20150330 ANDA ANDA091235 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0093-7701_a1c1316f-036f-4a92-8cc9-ab3629a886b9 0093-7701 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20110906 ANDA ANDA090199 Teva Pharmaceuticals USA, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0093-7755_32228020-6760-12fe-5fd9-e503993069da 0093-7755 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160209 NDA AUTHORIZED GENERIC NDA021656 Teva Pharmaceuticals USA Inc FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0093-7756_32228020-6760-12fe-5fd9-e503993069da 0093-7756 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160209 NDA AUTHORIZED GENERIC NDA021656 Teva Pharmaceuticals USA Inc FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0093-7771_495488db-49cb-4fa3-ab6a-eae8f5c5f3fb 0093-7771 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20161128 ANDA ANDA079215 Teva Pharmaceuticals USA, Inc. RISEDRONATE SODIUM MONOHYDRATE 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0093-7772_f1b99c9a-4b5b-41c5-9bf9-e392dde9f6e7 0093-7772 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20090918 ANDA ANDA074949 Teva Pharmaceuticals USA, Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-7807_b49078fe-51c0-46bf-b38b-399c6c6aaa45 0093-7807 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan, and Hydrochlorothiazide Amlodipine, Valsartan, and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 ANDA ANDA200435 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-7809_b49078fe-51c0-46bf-b38b-399c6c6aaa45 0093-7809 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan, and Hydrochlorothiazide Amlodipine, Valsartan, and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 ANDA ANDA200435 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 320; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-7810_b49078fe-51c0-46bf-b38b-399c6c6aaa45 0093-7810 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan, and Hydrochlorothiazide Amlodipine, Valsartan, and Hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 ANDA ANDA200435 Teva Pharmaceuticals USA, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-7865_c5b2c385-5027-4e50-bc43-c52faca28366 0093-7865 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20151208 NDA AUTHORIZED GENERIC NDA020747 Teva Pharmaceuticals USA, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0093-7866_c5b2c385-5027-4e50-bc43-c52faca28366 0093-7866 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20151208 NDA AUTHORIZED GENERIC NDA020747 Teva Pharmaceuticals USA, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0093-7867_c5b2c385-5027-4e50-bc43-c52faca28366 0093-7867 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20151208 NDA AUTHORIZED GENERIC NDA020747 Teva Pharmaceuticals USA, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0093-7868_c5b2c385-5027-4e50-bc43-c52faca28366 0093-7868 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20151208 NDA AUTHORIZED GENERIC NDA020747 Teva Pharmaceuticals USA, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0093-7869_c5b2c385-5027-4e50-bc43-c52faca28366 0093-7869 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20151208 NDA AUTHORIZED GENERIC NDA020747 Teva Pharmaceuticals USA, Inc. FENTANYL CITRATE 1200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0093-7870_c5b2c385-5027-4e50-bc43-c52faca28366 0093-7870 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20151208 NDA AUTHORIZED GENERIC NDA020747 Teva Pharmaceuticals USA, Inc. FENTANYL CITRATE 1600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0093-8034_fa4b19cd-5e5e-4d35-9bb1-05ed2fc97ebc 0093-8034 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19990511 ANDA ANDA074686 Teva Pharmaceuticals USA, Inc. GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0093-8035_fa4b19cd-5e5e-4d35-9bb1-05ed2fc97ebc 0093-8035 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19990511 ANDA ANDA074686 Teva Pharmaceuticals USA, Inc. GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0093-8036_fa4b19cd-5e5e-4d35-9bb1-05ed2fc97ebc 0093-8036 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19990512 ANDA ANDA074686 Teva Pharmaceuticals USA, Inc. GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0093-8117_4a7d13e9-9017-4d5c-81b2-f55e79c69f5c 0093-8117 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20070905 ANDA ANDA077487 Teva Pharmaceuticals USA, Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0093-8118_4a7d13e9-9017-4d5c-81b2-f55e79c69f5c 0093-8118 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20070905 ANDA ANDA077487 Teva Pharmaceuticals USA, Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0093-8119_4a7d13e9-9017-4d5c-81b2-f55e79c69f5c 0093-8119 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20070905 ANDA ANDA077487 Teva Pharmaceuticals USA, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0093-8162_318c525a-2f68-4d04-9553-0ff89b159365 0093-8162 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 Teva Pharmaceuticals USA, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-8163_318c525a-2f68-4d04-9553-0ff89b159365 0093-8163 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 Teva Pharmaceuticals USA, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-8164_318c525a-2f68-4d04-9553-0ff89b159365 0093-8164 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 Teva Pharmaceuticals USA, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-8165_318c525a-2f68-4d04-9553-0ff89b159365 0093-8165 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 Teva Pharmaceuticals USA, Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-8166_318c525a-2f68-4d04-9553-0ff89b159365 0093-8166 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 Teva Pharmaceuticals USA, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0093-8192_0e314475-7f69-45d6-a923-4019a790f7fa 0093-8192 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20031124 ANDA ANDA074151 Teva Pharmaceuticals USA Inc CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0093-8204_0e314475-7f69-45d6-a923-4019a790f7fa 0093-8204 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20040202 ANDA ANDA074151 Teva Pharmaceuticals USA Inc CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0093-8232_7926f4f1-5be8-4ca3-bad7-0689051de6bb 0093-8232 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130827 ANDA ANDA077369 Teva Pharmaceuticals USA, Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-8238_7926f4f1-5be8-4ca3-bad7-0689051de6bb 0093-8238 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130124 ANDA ANDA077369 Teva Pharmaceuticals USA, Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0093-8244_0b9f09d3-c3e8-4f02-bffa-19d215ce8ed5 0093-8244 HUMAN PRESCRIPTION DRUG LINEZOLID Linezolid TABLET, FILM COATED ORAL 20150622 NDA AUTHORIZED GENERIC NDA021130 Teva Pharmaceuticals USA Inc LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0093-8305_0e314475-7f69-45d6-a923-4019a790f7fa 0093-8305 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20031206 ANDA ANDA074463 Teva Pharmaceuticals USA Inc CIMETIDINE 800 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0093-8310_e4932f49-d533-4915-af91-7f7580fe4b6f 0093-8310 HUMAN PRESCRIPTION DRUG Eletriptan Hydrobromide Eletriptan Hydrobromide TABLET, FILM COATED ORAL 20170721 ANDA ANDA202040 Teva Pharmaceuticals USA, Inc. ELETRIPTAN HYDROBROMIDE 20 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0093-8311_e4932f49-d533-4915-af91-7f7580fe4b6f 0093-8311 HUMAN PRESCRIPTION DRUG Eletriptan Hydrobromide Eletriptan Hydrobromide TABLET, FILM COATED ORAL 20170721 ANDA ANDA202040 Teva Pharmaceuticals USA, Inc. ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0093-8342_f3181999-be8b-4fb2-b5b5-7213c3d09ca6 0093-8342 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Teva Pharmaceuticals USA Inc GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0093-8343_f3181999-be8b-4fb2-b5b5-7213c3d09ca6 0093-8343 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Teva Pharmaceuticals USA Inc GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0093-8344_f3181999-be8b-4fb2-b5b5-7213c3d09ca6 0093-8344 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Teva Pharmaceuticals USA Inc GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0093-8675_0679020a-3f86-4747-983d-9da82eea4333 0093-8675 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20040923 ANDA ANDA065162 Teva Pharmaceuticals USA Inc AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0093-8739_cd40cb9d-9cb1-4117-82e1-7c4eda399e8f 0093-8739 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 19950605 ANDA ANDA074377 Teva Pharmaceuticals USA, Inc. MEXILETINE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] N 20181231 0093-8740_cd40cb9d-9cb1-4117-82e1-7c4eda399e8f 0093-8740 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 19950605 ANDA ANDA074377 Teva Pharmaceuticals USA, Inc. MEXILETINE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC] N 20181231 0093-8741_cd40cb9d-9cb1-4117-82e1-7c4eda399e8f 0093-8741 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 19950605 ANDA ANDA074377 Teva Pharmaceuticals USA, Inc. MEXILETINE HYDROCHLORIDE 250 mg/1 Antiarrhythmic [EPC] N 20181231 0093-8940_172136ec-6f56-4bfb-8247-6716339fc406 0093-8940 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970423 ANDA ANDA074578 Teva Pharmaceuticals USA Inc ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0093-8943_172136ec-6f56-4bfb-8247-6716339fc406 0093-8943 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 Teva Pharmaceuticals USA Inc ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0093-8947_172136ec-6f56-4bfb-8247-6716339fc406 0093-8947 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970430 ANDA ANDA074556 Teva Pharmaceuticals USA Inc ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0093-9133_2a318004-d646-4881-9a20-b9cfb8656787 0093-9133 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 19981130 ANDA ANDA074739 Teva Pharmaceuticals USA, Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0093-9364_9af74481-0ac8-4019-9fb4-139c52f1c983 0093-9364 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 TEVA Pharmaceuticals USA Inc GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0093-9433_9af74481-0ac8-4019-9fb4-139c52f1c983 0093-9433 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 TEVA Pharmaceuticals USA Inc GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0093-9477_9af74481-0ac8-4019-9fb4-139c52f1c983 0093-9477 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 TEVA Pharmaceuticals USA Inc GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0093-9604_fcdcb3a6-0042-4b97-82e1-b32a94b98575 0093-9604 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol lactate SOLUTION, CONCENTRATE ORAL 19881201 ANDA ANDA071617 Teva Pharmaceuticals USA, Inc. HALOPERIDOL LACTATE 2 mg/mL Typical Antipsychotic [EPC] N 20181231 0093-9614_f4efeb4b-2509-4df7-ad17-c1c4b10d303a 0093-9614 HUMAN PRESCRIPTION DRUG Silver Nitrate Silver Nitrate SOLUTION TOPICAL 19910101 UNAPPROVED DRUG OTHER Teva Pharmaceuticals USA, Inc. SILVER NITRATE .005 g/mL N 20181231 0093-9643_65082813-530b-49f5-a588-fa947a87dd60 0093-9643 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 Teva Pharmaceuticals USA, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0093-9652_65082813-530b-49f5-a588-fa947a87dd60 0093-9652 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 Teva Pharmaceuticals USA, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0093-9660_f32b6d5f-71c4-409e-919c-35485d1935bc 0093-9660 HUMAN PRESCRIPTION DRUG Ethosuximide Ethosuximide SOLUTION ORAL 19940701 ANDA ANDA081306 Teva Pharmaceuticals USA, Inc. ETHOSUXIMIDE 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0095-0054_90422d3d-7d40-4e38-a17c-ce77715bdbf8 0095-0054 HUMAN PRESCRIPTION DRUG TussiCaps hydrocodone polistirex and chlorpheniramine polistirex CAPSULE, EXTENDED RELEASE ORAL 20110902 ANDA ANDA077273 ECR Pharmaceuticals HYDROCODONE; CHLORPHENIRAMINE 5; 4 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII E 20171231 0095-0073_49a31634-a2f7-46fa-ba93-fb2e5d99c0e4 0095-0073 HUMAN PRESCRIPTION DRUG HYLASE Wound Sodium Hyaluronate GEL TOPICAL 20120106 UNAPPROVED DRUG OTHER ECR Pharmaceuticals Co., Inc. HYALURONATE SODIUM 2.5 g/100g E 20171231 0095-0087_8f1a2830-d379-4f50-92f5-dad32008bb14 0095-0087 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20060901 ANDA ANDA040700 ECR Pharmaceuticals DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0095-0089_b58147e3-c769-42de-b1a4-a0457ce11c14 0095-0089 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20090401 ANDA ANDA040700 ECR Pharmaceuticals DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0095-0108_90422d3d-7d40-4e38-a17c-ce77715bdbf8 0095-0108 HUMAN PRESCRIPTION DRUG TussiCaps hydrocodone polistirex and chlorpheniramine polistirex CAPSULE, EXTENDED RELEASE ORAL 20110902 ANDA ANDA077273 ECR Pharmaceuticals HYDROCODONE; CHLORPHENIRAMINE 10; 8 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII E 20171231 0095-0201_1c6c2a83-33de-4992-8091-33d54c1bd0c6 0095-0201 HUMAN PRESCRIPTION DRUG VoSoL HC hydrocortisone and acetic acid SOLUTION AURICULAR (OTIC) 20090622 NDA NDA012770 ECR Pharmaceuticals Co., Inc. ACETIC ACID; HYDROCORTISONE 20.75; 10.375 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0095-0860_8063a87e-e511-4331-b705-37f335bd91c5 0095-0860 HUMAN OTC DRUG Lodrane D brompheniramine maleate and pseudoephedrine hydrochloride CAPSULE ORAL 20111021 OTC MONOGRAPH FINAL part341 ECR Pharmaceuticals BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 60 mg/1; mg/1 N 20181231 0095-3000_3171633f-c01e-42f0-bea2-2b2ad2685489 0095-3000 HUMAN PRESCRIPTION DRUG BUPAP Butalbital and Acetaminophen Tablets TABLET ORAL 20130624 ANDA ANDA090956 ECR Pharmaceuticals BUTALBITAL; ACETAMINOPHEN 50; 300 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 0096-0682_61187c9d-c5cb-1e95-e053-2991aa0a4af0 0096-0682 HUMAN OTC DRUG Solbar Shield SPF40 Solbar Shield SPF40 CREAM TOPICAL 19960601 OTC MONOGRAPH FINAL part352 Person and Covey TITANIUM DIOXIDE; ZINC OXIDE .05; .075 g/g; g/g N 20181231 0096-0685_61187c9d-c5cf-1e95-e053-2991aa0a4af0 0096-0685 HUMAN OTC DRUG Solbar Thirty SPF 30 Solbar Thirty SPF30 CREAM TOPICAL 19960601 OTC MONOGRAPH FINAL part352 Person and Covey HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE .12; .075; .06; .03; .015 g/g; g/g; g/g; g/g; g/g N 20181231 0096-0687_61187c9d-c5d0-1e95-e053-2991aa0a4af0 0096-0687 HUMAN OTC DRUG Solbar Avo SPF35 Solbar Avo SPF35 CREAM TOPICAL 19960601 OTC MONOGRAPH FINAL part352 Person and Covey HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE .08; .075; .06; .03 g/g; g/g; g/g; g/g N 20181231 0096-0688_61187317-4d2b-de63-e053-2a91aa0afe5b 0096-0688 HUMAN OTC DRUG Solbar Zinc SPF38 Solbar Zinc SPF38 CREAM TOPICAL 19960601 OTC MONOGRAPH FINAL part352 Person and Covey HOMOSALATE; OCTINOXATE; ZINC OXIDE .1015; .077; .077 1/g; 1/g; 1/g N 20181231 0096-0709_57d81736-f4c1-26cb-e053-2a91aa0a1be6 0096-0709 HUMAN OTC DRUG Xerac AC Xerac AC LIQUID TOPICAL 19960601 OTC MONOGRAPH FINAL part350 Person and Covey ALUMINUM CHLORIDE .0625 g/g N 20181231 0096-0735_6492fe01-e79f-e713-e053-2a91aa0ae4d9 0096-0735 HUMAN OTC DRUG DHS ZINC pyrithione zinc SHAMPOO TOPICAL 19950601 OTC MONOGRAPH FINAL part358H Person and Covey PYRITHIONE ZINC 20 mg/mL N 20191231 0096-0736_e6418e4b-22e0-4da9-9ebe-52507c98b54e 0096-0736 HUMAN OTC DRUG DHS TAR GEL 8 oz DHS TAR GEL SHAMPOO TOPICAL 19960601 OTC MONOGRAPH FINAL part358H Person and Covey COAL TAR .005 g/g E 20171231 0096-0737_61187317-4d2c-de63-e053-2a91aa0afe5b 0096-0737 HUMAN OTC DRUG DHS TAR coal tar SHAMPOO TOPICAL 19950601 OTC MONOGRAPH FINAL part358H Person and Covey COAL TAR .005 g/g N 20181231 0096-0741_61085ec6-ba3e-1560-e053-2991aa0ada02 0096-0741 HUMAN OTC DRUG Solbar Fifty SPF50 Solbar Fifty SPF50 CREAM TOPICAL 19960601 OTC MONOGRAPH FINAL part352 Solbar Fifty SPF 50 OCTOCRYLENE; OCTINOXATE; OXYBENZONE; AVOBENZONE .1; .08; .06; .011 g/g; g/g; g/g; g/g N 20181231 0113-0009_7a69de54-49aa-4384-b771-9982fcb52fa5 0113-0009 HUMAN OTC DRUG Good Sense Antacid calcium carbonate TABLET, CHEWABLE ORAL 20161201 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 750 mg/1 N 20181231 0113-0019_4eddeeae-475a-4df3-87bb-af82b9d438b5 0113-0019 HUMAN OTC DRUG Good Sense Severe NightTime Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20151021 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 0113-0020_d2d90b06-f981-4621-8a1c-f3952ab4f10b 0113-0020 HUMAN OTC DRUG good sense childrens pain and fever Acetaminophen SUSPENSION ORAL 20140320 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL N 20181231 0113-0022_a3b9c688-6656-4dc8-99de-64a154eaa83b 0113-0022 HUMAN OTC DRUG Good Sense Heartburn Relief Cimetidine TABLET ORAL 20021230 ANDA ANDA075285 L. Perrigo Company CIMETIDINE 200 mg/1 N 20181231 0113-0023_9ec6c31c-a509-4d9e-91e3-a8dc8d8b7765 0113-0023 HUMAN OTC DRUG good sense multi symptom flu and severe cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20161026 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 0113-0025_3cd7a952-e116-4867-921b-372e8465af27 0113-0025 HUMAN OTC DRUG Good Sense Pain Relief Acetaminophen TABLET, FILM COATED ORAL 20151006 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 500 mg/1 N 20181231 0113-0028_f26a4903-c92c-427d-a0e8-7cc7a99a653d 0113-0028 HUMAN OTC DRUG Good Sense 24 hour allergy nasal Fluticasone propionate SPRAY, METERED NASAL 20160803 ANDA ANDA207957 L. Perrigo Company FLUTICASONE PROPIONATE 50 ug/1 N 20181231 0113-0029_ac55741f-53c1-457a-8c81-594d6d1f4a39 0113-0029 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050506 ANDA ANDA076775 L. Perrigo Company NICOTINE 2 mg/1 N 20181231 0113-0031_efcdfdf5-93ac-4b44-a920-169757fea840 0113-0031 HUMAN OTC DRUG Good Sense Nasoflow Fluticasone propionate SPRAY, METERED NASAL 20160527 ANDA ANDA207957 L. Perrigo Company FLUTICASONE PROPIONATE 50 ug/1 N 20181231 0113-0032_b7154648-8c8c-4ce6-88b7-5442a16143c5 0113-0032 HUMAN OTC DRUG Good Sense Dual Action Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160106 ANDA ANDA077355 L Perrigo Company FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 0113-0040_3d2fa7ad-1574-4c79-959d-3ee284468a99 0113-0040 HUMAN OTC DRUG Good Sense Infants Ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20160205 ANDA ANDA075217 L. Perrigo Company IBUPROFEN 50 mg/1.25mL N 20181231 0113-0042_cffbc4ec-9d38-484c-8e1f-a49e6f88dd92 0113-0042 HUMAN OTC DRUG Good Sense Allergy Relief Chlorpheniramine Maleate TABLET ORAL 20160929 OTC MONOGRAPH FINAL part341 L. Perrigo Company CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 0113-0044_cb5f6008-6884-402a-8a19-c8d585576d63 0113-0044 HUMAN OTC DRUG Good Sense Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170509 ANDA ANDA075077 L. Perrigo Company ACETAMINOPHEN 650 mg/1 N 20181231 0113-0045_69614c6d-8859-4dde-b60c-25daac24a784 0113-0045 HUMAN OTC DRUG Good Sense omeprazole Omeprazole magnesium TABLET, DELAYED RELEASE ORAL 20171130 ANDA ANDA204152 L. Perrigo Company OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 0113-0047_61c143ea-eb38-4f96-8e05-6008a73f8573 0113-0047 HUMAN OTC DRUG Acid Reducer Maximum Strength Ranitidine TABLET ORAL 20080219 ANDA ANDA078653 L. Perrigo Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 0113-0050_fe02d3ab-4b1b-42c6-a235-573c9a57f9c1 0113-0050 HUMAN OTC DRUG good sense ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, FILM COATED ORAL 20090305 ANDA ANDA079113 L. Perrigo Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 0113-0052_a09ef6cd-1712-4e44-939c-aa50fdc647dc 0113-0052 HUMAN OTC DRUG good sense sleep time Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140206 OTC MONOGRAPH FINAL part338 L. Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0113-0053_fac52e0d-7a02-451e-a36b-30d49e929d3e 0113-0053 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170427 ANDA ANDA206393 L. Perrigo Company NICOTINE 4 mg/1 N 20181231 0113-0054_37795134-c4c0-49e1-8d24-673af431cb14 0113-0054 HUMAN OTC DRUG Good Sense Suphedrine 12 Hour Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19991029 ANDA ANDA075153 L. Perrigo Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 0113-0056_d7b22c69-de3b-497f-94ca-727d0d729906 0113-0056 HUMAN OTC DRUG good sense night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140530 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 0113-0057_13cdf9f9-e7f0-4dbb-bd4e-7aac8d42292f 0113-0057 HUMAN OTC DRUG Good Sense ibuprofen infants ibuprofen SUSPENSION ORAL 20000208 ANDA ANDA075217 L. Perrigo Company IBUPROFEN 50 mg/1.25mL N 20181231 0113-0058_bcf32242-de17-4da1-b707-4ce26262eb78 0113-0058 HUMAN OTC DRUG Good Sense Omeprazole and Sodium Bicarbonate Omeprazole, sodium bicarbonate CAPSULE, GELATIN COATED ORAL 20170619 ANDA ANDA201361 L. Perrigo Company OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 N 20181231 0113-0061_ed1b6e00-98b0-4e18-a1b6-6f081e032b98 0113-0061 HUMAN OTC DRUG good sense tussin mucus and chest congestion Guaifenesin SYRUP ORAL 19910115 OTC MONOGRAPH FINAL part341 L. Perrigo Company GUAIFENESIN 200 mg/10mL N 20181231 0113-0064_889b305b-d6cd-4772-abfe-325b4197b4e3 0113-0064 HUMAN OTC DRUG Good Sense Cold Max Acetaminophen, Dextromethorphan hbr, Phenylephrine hcl TABLET, FILM COATED ORAL 20170421 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0113-0065_81f4d9ee-d457-4c8d-a9a7-c5c8473c65bc 0113-0065 HUMAN OTC DRUG good sense nasal Oxymetazoline HCl SPRAY NASAL 19940323 OTC MONOGRAPH FINAL part341 L. Perrigo Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 0113-0066_e5540732-19e4-4895-a8ca-d87b75c37f6c 0113-0066 HUMAN OTC DRUG Good Sense Sinus plus Headache Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20170421 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 0113-0067_f3d7dfe5-6c1c-46bd-bfb3-48e12b2fee6f 0113-0067 HUMAN OTC DRUG Good Sense Triple Antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20060208 OTC MONOGRAPH FINAL part333B L Perrigo Company BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 0113-0074_19239a12-d915-40b3-8a6a-e326d3c733c6 0113-0074 HUMAN OTC DRUG Good Sense ibuprofen Ibuprofen TABLET, COATED ORAL 20060310 ANDA ANDA077349 L Perrigo Company IBUPROFEN 200 mg/1 N 20181231 0113-0081_c98919f5-b74d-4110-ba5e-c529229321ea 0113-0081 HUMAN OTC DRUG Good Sense Miconazole 3 Miconazole nitrate KIT 20070402 ANDA ANDA075329 L. Perrigo Company N 20181231 0113-0084_4b666482-1bc1-41b1-b146-89d38fa61744 0113-0084 HUMAN OTC DRUG Good Sense First Aid Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140428 OTC MONOGRAPH FINAL part333B L. Perrigo Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 0113-0090_4e9a64de-2922-4015-9588-4e8362c4dbb6 0113-0090 HUMAN OTC DRUG good sense DayTime Night Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110610 OTC MONOGRAPH FINAL part341 L Perrigo Company N 20181231 0113-0094_5e921900-0830-461a-9d6f-ba9b381f096a 0113-0094 HUMAN OTC DRUG Good Sense Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20050621 OTC MONOGRAPH FINAL part341 L. Perrigo Company PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 0113-0096_df959eef-f510-4d55-9261-b27532b67b37 0113-0096 HUMAN OTC DRUG good sense flu and severe cold and cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20110131 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 0113-0101_5f638cc1-870f-4577-b2ef-0bce61a2a9f3 0113-0101 HUMAN OTC DRUG Good Sense complete Lice Treatment Piperonyl butoxide, pyrethrum extract KIT 20160607 OTC MONOGRAPH FINAL part358G L. Perrigo Company N 20181231 0113-0110_da859235-7954-4f4f-91f2-c769bd05254c 0113-0110 HUMAN OTC DRUG fresh and pure Povidone-iodine KIT 20091109 OTC MONOGRAPH NOT FINAL part333A L Perrigo Company E 20171231 0113-0112_4235bee0-a820-4c4e-9a0a-e63cb1642915 0113-0112 HUMAN OTC DRUG good sense nausea relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20141103 UNAPPROVED DRUG OTHER L. Perrigo Company DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 0113-0116_d86585b7-e146-4f04-9016-412b16e06f55 0113-0116 HUMAN OTC DRUG Good Sense Lansoprazole Lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20171128 NDA NDA208025 L. Perrigo Company LANSOPRAZOLE 15 mg/1 N 20181231 0113-0117_923609b7-3b3a-4496-9dc7-97509a4fcf61 0113-0117 HUMAN OTC DRUG Good Sense lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120524 ANDA ANDA202319 L. Perrigo Company LANSOPRAZOLE 15 mg/1 N 20181231 0113-0134_a51515bf-c714-4927-a531-3e90771791c5 0113-0134 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20171220 OTC MONOGRAPH NOT FINAL part333A L. PERRIGO COMPANY BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/9mL; mg/9mL N 20181231 0113-0135_0c2cfe7e-478b-4f82-89e9-2cbbcc71c074 0113-0135 HUMAN OTC DRUG Lidocaine Burn Relief AEROSOL, SPRAY TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part348 L. Perrigo Company LIDOCAINE .64 g/127g N 20181231 0113-0136_74847c6c-8c2b-4f49-aecb-70a16d2f3212 0113-0136 HUMAN OTC DRUG Miconazole nitrate Antifungal Miconazole Liquid Continuous Spray AEROSOL, SPRAY TOPICAL 20120413 OTC MONOGRAPH FINAL part333C L. Perrigo Company MICONAZOLE NITRATE 3 g/150g N 20181231 0113-0137_e827fa2e-b994-4def-9c5d-fce15976cd53 0113-0137 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid LIQUID TOPICAL 20171220 OTC MONOGRAPH FINAL part358B L. Perrigo Company SALICYLIC ACID .17 mg/9mL N 20181231 0113-0138_e350ee00-80fc-4342-843b-37e37126b366 0113-0138 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20120103 OTC MONOGRAPH FINAL part358B L. Perrigo Company SALICYLIC ACID .17 mg/9.8mL N 20181231 0113-0141_cc77f6ff-a534-4731-b971-491280840899 0113-0141 HUMAN OTC DRUG good sense acid reducer Famotidine TABLET ORAL 20091023 ANDA ANDA075400 L Perrigo Company FAMOTIDINE 10 mg/1 N 20181231 0113-0144_816125d8-d06c-4571-bf34-5ca8c114c4f6 0113-0144 HUMAN OTC DRUG Good Sense Mucus D Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20160315 ANDA ANDA091071 L. Perrigo Company GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 0113-0145_06767693-e10c-4d56-a51d-711ea937d4fa 0113-0145 HUMAN OTC DRUG Good Sense Mucus Relief Cold and Sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130702 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 0113-0154_f91c03f0-6560-464b-a0fe-e63f6eb56c76 0113-0154 HUMAN OTC DRUG good sense athletes foot tolnaftate SPRAY TOPICAL 20050614 OTC MONOGRAPH FINAL part333C L. Perrigo Company TOLNAFTATE 1 g/100g N 20181231 0113-0160_6f85e72b-b323-4e1f-973c-5ced01564988 0113-0160 HUMAN OTC DRUG Good Sense Hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20121226 OTC MONOGRAPH FINAL part346 L. Perrigo Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g N 20181231 0113-0161_6143f3db-f3f9-4ba4-b365-5529c960d6ac 0113-0161 HUMAN OTC DRUG Good Sense pain and fever Acetaminophen SUSPENSION ORAL 20110921 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL N 20181231 0113-0166_cbac7d15-b1f7-47b9-a4ff-d8b81bd777e5 0113-0166 HUMAN OTC DRUG good sense ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020504 ANDA ANDA074937 L. Perrigo Company IBUPROFEN 100 mg/5mL N 20181231 0113-0170_1f3c994f-45ec-4e1d-b5bb-8141b09e9869 0113-0170 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050506 ANDA ANDA076789 L. Perrigo Company NICOTINE 4 mg/1 N 20181231 0113-0173_02390abe-962b-4eb6-90bf-1890569b3010 0113-0173 HUMAN OTC DRUG good sense complete lice treatment Piperonyl Butoxide, Pyrethrum Extract Shampoo KIT 20081119 OTC MONOGRAPH FINAL part358G L. Perrigo Company N 20181231 0113-0173_631a3be8-309e-48ae-9d89-e203251ffb0f 0113-0173 HUMAN OTC DRUG Good Sense Complete Lice Treatment Piperonyl Butoxide, Pyrethrum Extract KIT 20081119 OTC MONOGRAPH FINAL part358G L. Perrigo Company N 20181231 0113-0176_d5883129-0650-41ef-984d-a8fc4303f5fd 0113-0176 HUMAN OTC DRUG Good Sense All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080502 ANDA ANDA077170 L Perrigo Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 0113-0179_70720cab-00a9-4e1e-9a13-91e3f7314c4e 0113-0179 HUMAN OTC DRUG good sense antacid Calcium carbonate TABLET, CHEWABLE ORAL 19950525 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 750 mg/1 N 20181231 0113-0186_da97694a-8be7-4229-a4ce-40b4e2f1d15e 0113-0186 HUMAN OTC DRUG Good Sense Sleep Time Diphenhydramine HCl SOLUTION ORAL 20130702 OTC MONOGRAPH FINAL part338 L. Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 0113-0187_0d74cd35-e030-47dd-84e6-e6e85542c182 0113-0187 HUMAN OTC DRUG good sense pain relief extra strength Acetaminophen TABLET, COATED ORAL 19941005 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 500 mg/1 N 20181231 0113-0188_217aa2e7-e2d3-443c-a173-228531846015 0113-0188 HUMAN OTC DRUG Good Sense Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131121 OTC MONOGRAPH FINAL part346 L. Perrigo Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 0113-0189_c26ff9ca-a172-4edb-8996-ec2210e37fd8 0113-0189 HUMAN OTC DRUG Good Sense Childrens All Day Allergy Cetirizine HCl SOLUTION ORAL 20140103 ANDA ANDA204226 L. Perrigo Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0113-0194_26070c60-6c01-4404-8c25-923dcf01f3e4 0113-0194 HUMAN OTC DRUG Good Sense Acid Reducer Famotidine TABLET ORAL 20070316 ANDA ANDA077351 L. Perrigo Company FAMOTIDINE 20 mg/1 N 20181231 0113-0206_c512be4e-646f-421e-9096-5533b3e6dff1 0113-0206 HUMAN OTC DRUG good sense nicotine mint Nicotine Polacrilex GUM, CHEWING ORAL 19910415 ANDA ANDA078325 L. Perrigo Company NICOTINE 2 mg/1 N 20181231 0113-0212_9f9a6247-ae46-401f-9487-6d911372b9f7 0113-0212 HUMAN OTC DRUG Good Sense Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19930225 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL N 20181231 0113-0214_2616cdd8-fdc6-42d2-a043-8f6fc2f8e752 0113-0214 HUMAN OTC DRUG Good Sense Miconazole 7 Miconazole nitrate CREAM VAGINAL 19990730 ANDA ANDA074760 L Perrigo Company MICONAZOLE NITRATE 2 g/100g N 20181231 0113-0217_e862d1cf-3ccf-4000-9510-7dd03b18e471 0113-0217 HUMAN OTC DRUG good sense pain relief 8 hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060213 ANDA ANDA075077 L. Perrigo Company ACETAMINOPHEN 650 mg/1 N 20181231 0113-0224_3ede7f4c-6d0a-4619-857d-cd5755e0764c 0113-0224 HUMAN OTC DRUG Good Sense anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030225 ANDA ANDA075232 L. Perrigo Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 0113-0227_3dc530c9-60d2-4ef0-8a3a-0ee605dd39cb 0113-0227 HUMAN OTC DRUG Good Sense Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20060213 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 500 mg/1 N 20181231 0113-0234_61d0e899-89d4-447d-a973-f8c33fc606f5 0113-0234 HUMAN OTC DRUG good sense cold head congestion severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20080223 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0113-0259_cf9c4e4a-11e6-4108-ac3b-7838ca5e799b 0113-0259 HUMAN OTC DRUG good sense aspirin Aspirin TABLET, CHEWABLE ORAL 19990825 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ASPIRIN 81 mg/1 N 20181231 0113-0271_ae8ffdae-90d5-4d05-b3c9-37f7f336ead6 0113-0271 HUMAN OTC DRUG Good Sense Acid Reducer Ranitidine TABLET ORAL 20090521 ANDA ANDA076760 L Perrigo Company RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 0113-0272_7bde9308-5fac-4ae3-978b-c7d94ca891c3 0113-0272 HUMAN OTC DRUG Good Sense Sinus Congestion and Pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20061227 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 0113-0274_444b4ec9-2ce6-44d8-8371-0ea276a2cb8e 0113-0274 HUMAN OTC DRUG Good Sense aspirin Aspirin TABLET, CHEWABLE ORAL 19970808 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ASPIRIN 81 mg/1 N 20181231 0113-0279_d162b0a5-0d76-4558-aa0d-081bc7a65bb2 0113-0279 HUMAN OTC DRUG Good Sense Hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140904 OTC MONOGRAPH FINAL part346 L. Perrigo Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 0113-0285_6f3f64e6-d1f8-40d7-bb25-f6f279db9987 0113-0285 HUMAN OTC DRUG Good Sense 24 hour allergy nasal Fluticasone Propionate SPRAY, METERED NASAL 20171129 ANDA ANDA207957 L. Perrigo Company FLUTICASONE PROPIONATE 50 ug/1 N 20181231 0113-0288_e0ca9979-4850-4ebd-be67-8883bb075cb6 0113-0288 HUMAN OTC DRUG Good Sense Mucus Relief Guaifenesin LIQUID ORAL 20071106 OTC MONOGRAPH FINAL part341 L Perrigo Company GUAIFENESIN 100 mg/5mL N 20181231 0113-0294_db9c9efe-3012-43e2-86b6-a4c238d7fa25 0113-0294 HUMAN OTC DRUG good sense hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20120301 ANDA ANDA091344 L. Perrigo Company MINOXIDIL 5 g/100g N 20181231 0113-0296_eda7b964-789b-429d-a656-bd21437d2b2c 0113-0296 HUMAN OTC DRUG good sense tussin cf max dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20130111 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 0113-0299_aafcf4fc-8f04-44ac-9dc6-4cb5a98ac09c 0113-0299 HUMAN OTC DRUG good sense cold and flu severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140317 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0113-0302_41df421b-d321-4942-a2cc-bc961c413a42 0113-0302 HUMAN OTC DRUG Good Sense Stomach Relief original strength Bismuth subsalicylate SUSPENSION ORAL 19890915 OTC MONOGRAPH FINAL part335 L. Perrigo Company BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 0113-0304_1bb79206-f9d1-4f5e-b0e1-d59aa18b13a2 0113-0304 HUMAN OTC DRUG Good Sense Nasal oxymetazoline hydrochloride SPRAY NASAL 19890915 OTC MONOGRAPH FINAL part341 L. Perrigo Company OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 0113-0306_9020fa1c-cab7-4767-9d93-610fa873d11d 0113-0306 HUMAN OTC DRUG Good Sense Clear Lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 L. Perrigo Company POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 0113-0308_d5fd1911-e247-498b-a4ca-702e50d66542 0113-0308 HUMAN OTC DRUG Good Sense cold multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20100927 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0113-0310_3cf6891a-465a-4e47-950b-9d5357fc8cfa 0113-0310 HUMAN OTC DRUG good sense tussin chest congestion Guaifenesin SYRUP ORAL 19910115 OTC MONOGRAPH FINAL part341 L Perrigo Company GUAIFENESIN 100 mg/5mL N 20181231 0113-0321_72cd0797-e844-4e82-a4ce-7944cd38fae8 0113-0321 HUMAN OTC DRUG Good Sense Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080805 ANDA ANDA077355 L Perrigo Company FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 0113-0323_94d35eff-14aa-431a-8ceb-5dcdd3861752 0113-0323 HUMAN OTC DRUG Good Sense Lubricating Plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20131111 OTC MONOGRAPH FINAL part349 L. Perrigo Company CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM .5 g/100mL N 20181231 0113-0325_8dcd36a1-4d3b-4435-9b6b-a2428b5c6744 0113-0325 HUMAN OTC DRUG Good Sense Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170919 ANDA ANDA091009 L. Perrigo Company GUAIFENESIN 1200 mg/1 N 20181231 0113-0332_2e7346d9-1294-42af-a1ec-ec38c25662ac 0113-0332 HUMAN OTC DRUG good sense milk of magnesia stimulant free Magnesium hydroxide SUSPENSION ORAL 19910615 OTC MONOGRAPH NOT FINAL part334 L Perrigo Company MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0113-0335_45bc75a7-52fe-4add-a836-7571959bb7b9 0113-0335 HUMAN OTC DRUG good sense night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110819 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 0113-0337_b1ad8089-c96b-4cf0-94ff-f6ebd0c2b553 0113-0337 HUMAN OTC DRUG Good Sense Stomach Relief bismuth subsalicylate SUSPENSION ORAL 19900115 OTC MONOGRAPH FINAL part335 L. Perrigo Company BISMUTH SUBSALICYLATE 1050 mg/30mL N 20191231 0113-0340_0f6d6425-6709-4720-a567-34623745cf20 0113-0340 HUMAN OTC DRUG Good Sense antacid aluminum hydroxide, magnesium hydroxide, simethicone SUSPENSION ORAL 19900415 OTC MONOGRAPH FINAL part331 L. Perrigo Company ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 0113-0344_dabc8be3-57d6-408d-83f6-b77b6f558b0d 0113-0344 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex LOZENGE ORAL 20060725 ANDA ANDA077007 L. Perrigo Company NICOTINE 2 mg/1 N 20181231 0113-0345_095973c2-3955-4715-af9f-734c2c2a6991 0113-0345 HUMAN OTC DRUG Good Sense Severe Sinus Congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140128 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0113-0355_a83aa531-1747-4e89-9bd2-e7f2cb72e366 0113-0355 HUMAN OTC DRUG Good Sense headache pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19960912 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0113-0357_9c4e6173-6faf-4320-8f23-8b3895516658 0113-0357 HUMAN OTC DRUG Good Sense Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 19900715 OTC MONOGRAPH FINAL part331 L. Perrigo Company ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 0113-0359_e32b8a92-ccf0-4df6-9772-50616b6aa4fc 0113-0359 HUMAN OTC DRUG good sense tussin dm Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 19910918 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 0113-0371_86e58c67-1926-4eba-bd87-d175684c9fbf 0113-0371 HUMAN OTC DRUG Good Sense cold multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20071208 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0113-0374_760c3d28-f737-470b-8117-4ab190bf8480 0113-0374 HUMAN OTC DRUG good sense migraine formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20020417 ANDA ANDA075794 L. Perrigo Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0113-0379_b470f1be-63af-42c2-82c8-c6cd15841e1a 0113-0379 HUMAN OTC DRUG good sense allergy Diphenhydramine HCl SOLUTION ORAL 19890915 OTC MONOGRAPH FINAL part341 L. Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 0113-0381_fef5f24b-2057-4c9d-9d25-0636f7ad6f0c 0113-0381 HUMAN OTC DRUG Good Sense Mucus Relief cold flu and sore throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130626 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0113-0384_19f281dc-0628-4f02-99d5-2edd87a5f7e5 0113-0384 HUMAN OTC DRUG good sense cough dm dextromethorphan polistirex SUSPENSION ORAL 20130201 ANDA ANDA091135 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 0113-0388_3cb2e2b5-aab9-44be-b980-9a14f71cd3e2 0113-0388 HUMAN OTC DRUG good sense nasal Oxymetazoline HCl SPRAY NASAL 20020513 OTC MONOGRAPH FINAL part341 L. Perrigo Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 0113-0396_f40afeb2-f09e-4158-9dfe-d00f1cc102af 0113-0396 HUMAN OTC DRUG Good Sense milk of magnesia stimulant free Magnesium hydroxide SUSPENSION ORAL 19910615 OTC MONOGRAPH NOT FINAL part334 L. Perrigo Company MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0113-0397_c58aecd1-a627-4453-9f91-076bdb9a8425 0113-0397 HUMAN OTC DRUG Good Sense Pain and Fever acetaminophen SUSPENSION ORAL 20120322 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL N 20181231 0113-0400_a7b35676-10e7-48db-8a4d-29f271471ad3 0113-0400 HUMAN OTC DRUG Good Sense Hemorrhoidal Mineral oil, Petrolatum, Phenylephrine HCl, Shark liver oil OINTMENT TOPICAL 19951220 OTC MONOGRAPH FINAL part346 L Perrigo Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 14; 71.9; .25; 3 g/100g; g/100g; g/100g; g/100g N 20181231 0113-0401_bd2b6f2e-617e-48c9-8f35-70ceea3ee107 0113-0401 HUMAN OTC DRUG Zephrex D pseudoephedrine hydrochloride CAPSULE, GELATIN COATED ORAL 20161104 OTC MONOGRAPH FINAL part341 L. Perrigo Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 0113-0403_a640c113-8582-4f1a-a4d8-1d6b336ff635 0113-0403 HUMAN OTC DRUG good sense pain relief Acetaminophen TABLET ORAL 19890815 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 325 mg/1 N 20181231 0113-0404_5f70e468-be32-4c4f-891e-437bc38fe9fd 0113-0404 HUMAN OTC DRUG good sense allergy relief 4 hour Chlorpheniramine Maleate TABLET ORAL 19910729 OTC MONOGRAPH FINAL part341 L. Perrigo Company CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 0113-0409_17f59573-a287-420d-9389-346c0ffd9885 0113-0409 HUMAN OTC DRUG good sense stay awake Caffeine TABLET ORAL 19930323 OTC MONOGRAPH FINAL part340 L. Perrigo Company CAFFEINE 200 mg/1 N 20181231 0113-0416_4e27246f-f8a9-408f-a57d-6eae3341562b 0113-0416 HUMAN OTC DRUG good sense aspirin Aspirin TABLET ORAL 19910415 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ASPIRIN 325 mg/1 N 20181231 0113-0419_c9001f80-59d0-4b01-863f-425887b3c30a 0113-0419 HUMAN OTC DRUG Good Sense Childrens Mucus Relief Cough Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 20071127 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 0113-0422_17a045c8-8bcb-429c-9804-1b6a11f8cb54 0113-0422 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050422 ANDA ANDA078326 L. Perrigo Company NICOTINE 4 mg/1 N 20181231 0113-0425_874b3b0a-06f7-442f-a83e-60d2425105b7 0113-0425 HUMAN OTC DRUG Good Sense Aller Ease Fexofenadine HCl TABLET, FILM COATED ORAL 20110914 ANDA ANDA076447 L. Perrigo Company FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 0113-0428_e9b17949-c063-42de-af3e-e20a7a46e3f2 0113-0428 HUMAN OTC DRUG Good Sense Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 19990209 OTC MONOGRAPH FINAL part332 L. Perrigo Company DIMETHICONE 125 mg/1 N 20181231 0113-0431_e76b2182-eaa3-40e1-887e-76b46a2eba0a 0113-0431 HUMAN OTC DRUG good sense nighttime sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20010425 OTC MONOGRAPH FINAL part338 L. Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0113-0432_697f1df8-e9f8-43dc-8366-dc90e46f49b4 0113-0432 HUMAN OTC DRUG Good Sense Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19890915 OTC MONOGRAPH FINAL part341 L. Perrigo Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 0113-0437_13a41619-6cd9-4403-830a-de8c0d6dd6c9 0113-0437 HUMAN OTC DRUG good sense pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19920723 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0113-0441_438a81ec-0c5f-466f-8457-260d2776f044 0113-0441 HUMAN OTC DRUG Good sense sleep aid Doxylamine succinate TABLET ORAL 19970414 ANDA ANDA040167 L. Perrigo Company DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 0113-0443_6d813e26-0254-489f-9163-81b6715559da 0113-0443 HUMAN OTC DRUG Good Sense Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20170209 ANDA ANDA078104 L. Perrigo Company TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 0113-0456_71c030f9-2ac0-4f5f-b040-bdaa33e049bf 0113-0456 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070307 ANDA ANDA076777 L. Perrigo Company NICOTINE 2 mg/1 N 20181231 0113-0459_65c2a40a-e070-49d9-b289-6b778978f5d0 0113-0459 HUMAN OTC DRUG good sense nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110822 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 0113-0461_67e15204-4f36-434d-8b2d-4889d7608204 0113-0461 HUMAN OTC DRUG Good Sense ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20041109 ANDA ANDA076359 L Perrigo Company IBUPROFEN 100 mg/1 N 20181231 0113-0462_c1f80733-ebbd-4eab-b2e4-e58470e7c81b 0113-0462 HUMAN OTC DRUG Good Sense Allergy Relief diphenhydramine hydrochloride CAPSULE ORAL 19890915 OTC MONOGRAPH FINAL part341 L. Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0113-0467_23f4e2c8-2b36-4ad6-81a0-a8ce25e0912e 0113-0467 HUMAN OTC DRUG good sense aspirin Aspirin TABLET, CHEWABLE ORAL 19921104 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ASPIRIN 81 mg/1 N 20181231 0113-0468_27fa627c-c642-4e90-9dff-f4e92e994732 0113-0468 HUMAN OTC DRUG good sense antacid Calcium carbonate TABLET, CHEWABLE ORAL 19970918 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 750 mg/1 N 20181231 0113-0469_cd58f3d3-ca22-4ed8-82b9-c7e71286b390 0113-0469 HUMAN OTC DRUG good sense stomach relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 19930824 OTC MONOGRAPH FINAL part335 L. Perrigo Company BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 0113-0476_38d8126e-6d50-4af9-8e67-32d3e4bf814b 0113-0476 HUMAN OTC DRUG Good Sense Allergy Multi Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20051006 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 0113-0477_d38209ad-37a5-4ca1-9110-4ce65c2b4f4c 0113-0477 HUMAN OTC DRUG Good Sense Fiber Laxative Calcium polycarbophil TABLET, FILM COATED ORAL 19970801 OTC MONOGRAPH NOT FINAL part334 L. Perrigo Company CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 0113-0478_f360779d-1e86-47b7-9b0a-5d0d017d2be5 0113-0478 HUMAN OTC DRUG good sense antacid calcium carbonate TABLET, CHEWABLE ORAL 19891215 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 500 mg/1 N 20181231 0113-0479_cfc18746-99f8-4bbc-a5e2-1e368c4f7f1c 0113-0479 HUMAN OTC DRUG good sense allergy relief Diphenhydramine Hydrochloride TABLET ORAL 19910820 OTC MONOGRAPH FINAL part341 L. Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0113-0484_577c2c66-46a0-4045-a126-7cac7a8fc2af 0113-0484 HUMAN OTC DRUG Good Sense Pain Relief Acetaminophen TABLET ORAL 19890915 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 500 mg/1 N 20181231 0113-0485_6cc0fbb9-6ea1-4b5f-953f-d24d4d4d1e6d 0113-0485 HUMAN OTC DRUG good sense antacid calcium carbonate TABLET, CHEWABLE ORAL 19920617 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 500 mg/1 N 20181231 0113-0486_0ad272d0-eeea-4890-86d2-aa0304dc438c 0113-0486 HUMAN OTC DRUG good sense stool softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 19911029 OTC MONOGRAPH NOT FINAL part334 L. Perrigo Company DOCUSATE SODIUM 100 mg/1 N 20181231 0113-0489_e2af0e84-ea92-4ce3-a219-55d23acca2fa 0113-0489 HUMAN OTC DRUG good sense antacid Calcium carbonate TABLET, CHEWABLE ORAL 20010228 OTC MONOGRAPH FINAL part331 L Perrigo Company CALCIUM CARBONATE 750 mg/1 N 20181231 0113-0503_e56edd0e-4873-41bc-a727-05c02ec943ed 0113-0503 HUMAN OTC DRUG Good Sense Childrens All Day Allergy Cetirizine HCl SOLUTION ORAL 20160111 ANDA ANDA204226 L. Perrigo Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0113-0516_0ab3f68b-372f-4c9b-b1dc-f60d2f463fe8 0113-0516 HUMAN OTC DRUG good sense tussin cf cough and cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20060428 OTC MONOGRAPH FINAL part341 L Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 0113-0517_aebae4b3-18c8-4ecf-b578-1fe7cc50076b 0113-0517 HUMAN OTC DRUG Good Sense ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060427 ANDA ANDA077349 L Perrigo Company IBUPROFEN 200 mg/1 N 20181231 0113-0532_a65e246e-9ee7-4e3d-a3db-60392871da42 0113-0532 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 19900715 ANDA ANDA076779 L. Perrigo Company NICOTINE 4 mg/1 N 20181231 0113-0541_fe060975-7690-44c4-b4ed-74c8b999e607 0113-0541 HUMAN OTC DRUG good sense anti itch Hydrocortisone CREAM TOPICAL 20060224 OTC MONOGRAPH NOT FINAL part348 L. Perrigo Company HYDROCORTISONE 1 g/100g N 20181231 0113-0544_0079600e-ce24-4a24-968e-a3b7787df40f 0113-0544 HUMAN OTC DRUG good sense pain relief arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA075077 L Perrigo Company ACETAMINOPHEN 650 mg/1 N 20181231 0113-0548_09b2e30a-b089-4c8b-a51c-b521ba517e1b 0113-0548 HUMAN OTC DRUG Good Sense Severe Daytime Cold and Flu acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20131119 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0113-0567_ead8b55e-f365-479f-9c52-77d44acae134 0113-0567 HUMAN OTC DRUG Good Sense NightTime DayTime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140103 OTC MONOGRAPH FINAL part341 L. Perrigo Company N 20181231 0113-0571_ed5cfb58-7a3c-4ae4-ae30-054130f2b813 0113-0571 HUMAN OTC DRUG good sense aller ease fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 L. Perrigo Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 0113-0578_3e6f0c8a-2b16-4f50-ad09-5377d6d46dde 0113-0578 HUMAN OTC DRUG good sense tussin dm cough and chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19940920 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 0113-0579_3b3c8417-d7fd-4d43-9a7f-4ac191079cab 0113-0579 HUMAN OTC DRUG good sense severe cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140523 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0113-0588_0400ba14-03a1-4b2c-9684-7faca07c4045 0113-0588 HUMAN OTC DRUG Good Sense Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone SUSPENSION ORAL 20060213 OTC MONOGRAPH FINAL part332 L. Perrigo Company ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 0113-0590_b16589cd-bde7-4b48-90cf-02005eff25dc 0113-0590 HUMAN OTC DRUG Good Sense Pain and Fever acetaminophen SUSPENSION ORAL 20111108 OTC MONOGRAPH NOT FINAL part343 L Perrigo Company ACETAMINOPHEN 160 mg/5mL N 20181231 0113-0595_4d7c3270-a6c1-4697-bc2a-233dd990907c 0113-0595 HUMAN OTC DRUG good sense antacid Calcium Carbonate TABLET, CHEWABLE ORAL 19950601 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 1000 mg/1 N 20181231 0113-0603_93c35a8d-f3ff-4bf5-ba1f-4a8d2a369bd0 0113-0603 HUMAN OTC DRUG Good Sense Severe Daytime Cold and Flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20131119 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 0113-0604_32a5725e-6c44-4b3f-90f7-7c7aa142b695 0113-0604 HUMAN OTC DRUG good sense ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19890915 ANDA ANDA072096 L. Perrigo Company IBUPROFEN 200 mg/1 N 20181231 0113-0608_e9ff5bcf-afca-40ee-97aa-edb72f7b0206 0113-0608 HUMAN OTC DRUG good sense childrens pain and fever Acetaminophen SUSPENSION ORAL 19931008 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL N 20181231 0113-0612_f5e901fb-5c30-470b-9134-0a1105d23115 0113-0612 HUMAN OTC DRUG good sense allergy relief Loratadine TABLET ORAL 20040921 ANDA ANDA076301 L. Perrigo Company LORATADINE 10 mg/1 N 20181231 0113-0622_c8bb8bb3-88c8-432e-80b7-a9a803f22010 0113-0622 HUMAN OTC DRUG good sense itch relief Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20060718 OTC MONOGRAPH NOT FINAL part348 L. Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 0113-0645_dbf15c26-0deb-4285-80bf-59cc253182f5 0113-0645 HUMAN OTC DRUG good sense loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120131 ANDA ANDA091292 L. Perrigo Company LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 0113-0647_ddbead0d-569d-43e0-b442-edb94f9884c9 0113-0647 HUMAN OTC DRUG good sense ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19910215 ANDA ANDA072096 L. Perrigo Company IBUPROFEN 200 mg/1 N 20191231 0113-0648_299ded55-1d9b-4958-8de8-d9557a5cc7c1 0113-0648 HUMAN OTC DRUG Good Sense Nasal Four Phenylephrine hydrochloride SPRAY NASAL 20020809 OTC MONOGRAPH FINAL part341 L Perrigo Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 0113-0656_29653a9b-0422-41e0-b84b-f4c5a5ffa10e 0113-0656 HUMAN OTC DRUG Good Sense Daytime non drowsy cold and flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20060725 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 0113-0657_14caaf5a-6877-40f9-af8f-fb48de94ecfe 0113-0657 HUMAN OTC DRUG good sense gas relief Simethicone CAPSULE, LIQUID FILLED ORAL 20020405 OTC MONOGRAPH FINAL part332 L Perrigo Company DIMETHICONE 180 mg/1 N 20181231 0113-0660_1336730f-5dee-48d7-99e8-fe98190e2276 0113-0660 HUMAN OTC DRUG Good Sense Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20020409 ANDA ANDA074937 L. Perrigo Company IBUPROFEN 100 mg/5mL N 20181231 0113-0666_04c0fed5-bce6-4f02-9955-95f7071676e2 0113-0666 HUMAN OTC DRUG good sense cough and sore throat night time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060914 OTC MONOGRAPH FINAL part341 L Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 0113-0668_9e05da42-6f93-4305-b7da-2eb6bd41e8c2 0113-0668 HUMAN OTC DRUG Good Sense Nighttime Cough Dextromethorphan Hydrobromide, Doxylamine Succinate SOLUTION ORAL 20021103 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 0113-0679_9bd1956f-ece5-4324-a7b9-4083f5db7937 0113-0679 HUMAN OTC DRUG Good Sense Triple Antibiotic and Pain Relief Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20060214 OTC MONOGRAPH FINAL part333B L. Perrigo Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 0113-0685_1fda427d-2145-4653-ad35-e78f2100c5c7 0113-0685 HUMAN OTC DRUG Good Sense Ibuprofen Ibuprofen SUSPENSION ORAL 20110428 ANDA ANDA074937 L. Perrigo Company IBUPROFEN 100 mg/5mL N 20181231 0113-0692_1d04b953-04ce-4a76-9d3d-1745ef5ec708 0113-0692 HUMAN OTC DRUG good sense cool heat Menthol, Methyl salicylate CREAM TOPICAL 20140415 OTC MONOGRAPH NOT FINAL part348 L. Perrigo Company MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 0113-0695_900cfab2-16e7-4e14-afc5-0bd4200c2dd1 0113-0695 HUMAN OTC DRUG good sense jock itch Tolnaftate SPRAY TOPICAL 20050615 OTC MONOGRAPH FINAL part333C L. Perrigo Company TOLNAFTATE 1 g/100g N 20181231 0113-0703_74b77a69-0e51-4f83-acd4-a66abb1ef74c 0113-0703 HUMAN OTC DRUG Good Sense Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20140729 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 0113-0704_633bf6e1-118d-45a7-bab7-688323eb5d75 0113-0704 HUMAN OTC DRUG basic care nicotine Nicotine polacrilex GUM, CHEWING ORAL 20180122 ANDA ANDA206394 L. Perrigo Company NICOTINE 2 mg/1 N 20191231 0113-0713_7263b5e6-ed86-472f-92c8-53776755db54 0113-0713 HUMAN OTC DRUG basic care nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20180109 ANDA ANDA206393 L. Perrigo Company NICOTINE 4 mg/1 N 20191231 0113-0732_5f6ca907-37a3-42ce-a4c1-99af29525ead 0113-0732 HUMAN OTC DRUG basic care esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20180109 ANDA ANDA207193 L. Perrigo Company ESOMEPRAZOLE 20 mg/1 N 20191231 0113-0734_a884dfa6-40f8-4112-9a7c-3f6bc9d35c14 0113-0734 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex LOZENGE ORAL 20130422 ANDA ANDA203690 L. Perrigo Company NICOTINE 2 mg/1 N 20181231 0113-0749_840831ad-65eb-4123-81cc-d71d0540d452 0113-0749 HUMAN OTC DRUG basic care nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20171227 ANDA ANDA078326 L. Perrigo Company NICOTINE 4 mg/1 N 20191231 0113-0751_e99ba6a6-d2ba-4c61-892f-a8cfb23d04be 0113-0751 HUMAN OTC DRUG good sense pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120125 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0113-0761_973958b6-d778-4ce2-b2e6-be363343a3d6 0113-0761 HUMAN OTC DRUG basic care nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20171219 ANDA ANDA078325 L. Perrigo Company NICOTINE 2 mg/1 N 20191231 0113-0773_4f90dbee-c333-4a3b-bbf8-373567eecf9d 0113-0773 HUMAN OTC DRUG Basic Care Aspirin Aspirin TABLET, FILM COATED ORAL 20171219 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ASPIRIN 325 mg/1 N 20191231 0113-0788_ac66c5ba-97c1-4e13-8c9e-d4b3be442faf 0113-0788 HUMAN OTC DRUG Basic Care ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20171219 ANDA ANDA076359 L. Perrigo Company IBUPROFEN 100 mg/1 N 20191231 0113-0791_686bd5a5-5d30-4993-b51e-d6dd8f7af16a 0113-0791 HUMAN OTC DRUG tussin dm Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20180109 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20191231 0113-0798_541712ec-166b-46f7-ab58-87277cc9dc2e 0113-0798 HUMAN OTC DRUG Good Sense Hair Regrowth Treatment for Men Minoxidil SOLUTION TOPICAL 20100210 ANDA ANDA075598 L. Perrigo Company MINOXIDIL 3 g/60mL N 20181231 0113-0799_93360532-2a98-4cdd-8eb5-dd7dd9a71a59 0113-0799 HUMAN OTC DRUG Good Sense tussin dm max Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20100415 OTC MONOGRAPH FINAL part341 L Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 0113-0817_27d76b10-b491-4a01-b804-e4542347603a 0113-0817 HUMAN OTC DRUG Good Sense Nasal oxymetazoline hydrochloride SPRAY NASAL 19960418 OTC MONOGRAPH FINAL part341 L. Perrigo Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 0113-0825_f9155195-6650-418c-a9cb-fa71f30f817e 0113-0825 HUMAN OTC DRUG good sense miconazole 7 Miconazole nitrate CREAM VAGINAL 20000222 ANDA ANDA074760 L. Perrigo Company MICONAZOLE NITRATE 2 g/100g N 20181231 0113-0829_7c480605-b2c6-48fc-b526-3f3546219c52 0113-0829 HUMAN OTC DRUG Good Sense pain relief pm extra strength Acetaminophen, Diphenhydramine HCl CAPSULE, COATED ORAL 19910615 OTC MONOGRAPH FINAL part338 L Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0113-0837_399994e2-ab8c-4523-b79b-817cf1b06e02 0113-0837 HUMAN OTC DRUG Good Sense Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 19980126 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0113-0839_223c28ae-c8e6-4613-b46b-18a90ecb2799 0113-0839 HUMAN OTC DRUG Good Sense Childrens Mucus Relief dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20140325 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 0113-0851_3eac6267-429a-4a16-9415-5c213c0eb558 0113-0851 HUMAN OTC DRUG good sense antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20030204 OTC MONOGRAPH FINAL part332 L. Perrigo Company ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 0113-0852_8a95b38f-4958-4ab6-9c73-ba2e6bab18a0 0113-0852 HUMAN OTC DRUG Good Sense Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20140205 ANDA ANDA091429 L. Perrigo Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 0113-0854_df4fd78c-231b-4771-8bad-1dfc5448c9d8 0113-0854 HUMAN OTC DRUG Good Sense Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20130514 ANDA ANDA078546 L. Perrigo Company NICOTINE 4 mg/1 N 20181231 0113-0857_fa6abf22-246e-411d-a8e4-82d0fe897e6f 0113-0857 HUMAN OTC DRUG Good Sense Athletes Foot antifungal Clotrimazole CREAM TOPICAL 20060409 OTC MONOGRAPH FINAL part333C L. Perrigo Company CLOTRIMAZOLE 1 g/100g N 20181231 0113-0866_560ed35e-1d86-40f8-aae4-b9f902ca8873 0113-0866 HUMAN OTC DRUG good sense lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20071208 OTC MONOGRAPH FINAL part358G L Perrigo Company PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 0113-0873_b5fea7eb-e206-4175-b719-8ca44c32c879 0113-0873 HUMAN OTC DRUG good sense nicotine Nicotine Polacrilex LOZENGE ORAL 20061227 ANDA ANDA077007 L. Perrigo Company NICOTINE 4 mg/1 N 20181231 0113-0876_4b973980-db66-4414-bb59-383d2d59530b 0113-0876 HUMAN OTC DRUG Good Sense Acid Reducer Ranitidine TABLET, COATED ORAL 20160613 ANDA ANDA076195 L. Perrigo Company RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 0113-0881_52cb7482-12e9-42eb-a460-08793cfd4dc3 0113-0881 HUMAN OTC DRUG Good Sense Antacid calcium carbonate TABLET, CHEWABLE ORAL 20140923 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 1000 mg/1 N 20181231 0113-0882_facbdec7-eb5e-42dc-8ca3-02a426425797 0113-0882 HUMAN OTC DRUG good sense simethicone infants Simethicone EMULSION ORAL 20000223 OTC MONOGRAPH FINAL part332 L Perrigo Company DIMETHICONE 20 mg/.3mL N 20181231 0113-0896_f32028af-daf8-499b-ac83-48c2a065aad7 0113-0896 HUMAN OTC DRUG Good Sense Lubricant Eye Polyethylene glycol, Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20140218 OTC MONOGRAPH FINAL part349 L. Perrigo Company POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL E 20171231 0113-0897_0ce3c522-4b65-4cd5-b4a8-092714a0c4c4 0113-0897 HUMAN OTC DRUG good sense ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990107 ANDA ANDA074937 L. Perrigo Company IBUPROFEN 100 mg/5mL N 20181231 0113-0898_4a89b4b5-5c42-44ee-98a9-e26a237aaef7 0113-0898 HUMAN OTC DRUG Good Sense Esomeprazole Magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170922 ANDA ANDA207193 L. Perrigo Company ESOMEPRAZOLE 20 mg/1 N 20181231 0113-0901_29400f56-dd35-4481-ae78-070369252264 0113-0901 HUMAN OTC DRUG Good Sense Naproxen Sodium Naproxen Sodium TABLET ORAL 20140423 ANDA ANDA074661 L. Perrigo Company NAPROXEN SODIUM 220 mg/1 N 20181231 0113-0903_fbc03aa0-8fa5-4607-ae14-064e8904a06d 0113-0903 HUMAN OTC DRUG good sense cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20101222 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 0113-0904_7223cd65-b908-49ff-a192-58efa1e8bfc9 0113-0904 HUMAN OTC DRUG good sense antacid Calcium carbonate TABLET, CHEWABLE ORAL 20140923 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 1000 mg/1 E 20171231 0113-0906_2165d390-ca7d-4e9f-8e76-5759407ed6ad 0113-0906 HUMAN OTC DRUG good sense childrens cold and allergy phenylephrine hcl, brompheniramine maleate SOLUTION ORAL 20070224 OTC MONOGRAPH FINAL part341 L. Perrigo Company PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 0113-0911_8aa0f0fe-4393-41b1-bdf9-7148c53db381 0113-0911 HUMAN OTC DRUG good sense childrens ibuprofen oral suspension Ibuprofen SUSPENSION ORAL 20020409 ANDA ANDA074937 L Perrigo Company IBUPROFEN 100 mg/5mL N 20181231 0113-0915_75c77192-e034-48bd-a878-11160c1592e5 0113-0915 HUMAN OTC DRUG Good Sense Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080228 NDA NDA022032 L. Perrigo Company OMEPRAZOLE 20 mg/1 N 20181231 0113-0916_2ead9ac3-c54c-45fb-88d2-214fa0be1b2c 0113-0916 HUMAN OTC DRUG good sense miconazole 1 Miconazole nitrate KIT 20100629 ANDA ANDA079114 L. Perrigo Company N 20181231 0113-0934_f762ee6b-9cf5-4533-9aab-154d8d13924c 0113-0934 HUMAN OTC DRUG Good Sense Adult Tussin DM dextromethorphan hbr, guaifenesin SUSPENSION ORAL 20130920 OTC MONOGRAPH FINAL part341 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 0113-0944_a402f156-f36c-4c06-b245-d9de266d2cc9 0113-0944 HUMAN OTC DRUG Good Sense Hemorrhoidal Maximum Strength Pain Relief glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20080228 OTC MONOGRAPH FINAL part346 L. Perrigo Company GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 0113-0946_549e04b4-c925-4b9c-9b4c-fea1df778676 0113-0946 HUMAN OTC DRUG good sense pain and fever infants Acetaminophen SUSPENSION ORAL 20111108 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL N 20181231 0113-0949_aae9a7aa-b257-462e-80c7-661846a7c905 0113-0949 HUMAN OTC DRUG Good Sense Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20050711 OTC MONOGRAPH NOT FINAL part334 L. Perrigo Company MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0113-0957_2067711c-bf2e-429d-b9b0-35b14b929f72 0113-0957 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex LOZENGE ORAL 20130427 ANDA ANDA203690 L. Perrigo Company NICOTINE 4 mg/1 N 20181231 0113-0958_b59bcc02-a3a4-47b7-87de-c100ea7c3056 0113-0958 HUMAN OTC DRUG Good Sense Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130620 ANDA ANDA091135 L. Perrigo Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 0113-0962_9242df77-b8c8-4c3c-af0d-ad75ebea61ce 0113-0962 HUMAN OTC DRUG good sense antacid Calcium carbonate TABLET, CHEWABLE ORAL 20140923 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 1000 mg/1 N 20181231 0113-0964_131469d1-4bb1-45ec-b59f-10cb2393dbf4 0113-0964 HUMAN OTC DRUG good sense flu and severe cold and cough nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100917 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 0113-0973_9d86f709-e5db-49e5-85c6-09f4d666ece3 0113-0973 HUMAN OTC DRUG Good Sense Anti Itch hydrocortisone CREAM TOPICAL 20060307 OTC MONOGRAPH NOT FINAL part348 L Perrigo Company HYDROCORTISONE 1 g/100g N 20181231 0113-0974_8bf39f7d-fee7-4457-b475-630932b34e42 0113-0974 HUMAN OTC DRUG good sense childrens all day allergy cetirizine hydrochloride LIQUID ORAL 20080418 ANDA ANDA090254 L Perrigo Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0113-0987_1376e407-913f-47d0-92d7-374d8a0442fb 0113-0987 HUMAN OTC DRUG Good Sense Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20070224 OTC MONOGRAPH FINAL part341 L. Perrigo Company BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 0113-0994_f759f3ad-204f-49e0-95e9-30f097711510 0113-0994 HUMAN OTC DRUG good sense daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070118 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0113-0997_04806a84-c52b-4304-be33-269152222017 0113-0997 HUMAN OTC DRUG Good Sense Sinus Relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20160810 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 0113-0998_39f34cb8-b1ee-406e-93d5-fbcaf0afde1e 0113-0998 HUMAN OTC DRUG Good Sense Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20100729 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL N 20181231 0113-1165_11bc7e68-0956-4e74-b182-e3a63cd3b96e 0113-1165 HUMAN OTC DRUG good sense allergy and congestion relief non drowsy 24 hour Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20030624 ANDA ANDA075706 L Perrigo Company PSEUDOEPHEDRINE SULFATE; LORATADINE 240; 10 mg/1; mg/1 N 20181231 0113-2002_821ad600-7f10-4afa-b656-32d043d6ff46 0113-2002 HUMAN OTC DRUG Mucus D Guaifenesin, pseudoephedrine hydrochloride TABLET ORAL 20160302 ANDA ANDA091071 L. Perrigo Company GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 0113-2003_4ba7ab39-ae81-428f-a031-2aab8f4d9349 0113-2003 HUMAN OTC DRUG Option 2 levonorgestrel TABLET ORAL 20160129 ANDA ANDA202334 L. Perrigo Company LEVONORGESTREL 1.5 mg/1 N 20181231 0113-2004_3f908d00-fd3c-47eb-a7ec-6a00366881a6 0113-2004 HUMAN OTC DRUG sinus PE Phenylephrine Hydrochloride TABLET ORAL 20150918 OTC MONOGRAPH FINAL part341 L. Perrigo Company PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 0113-2008_c41865bc-3f6e-4213-b499-fc9d9d96cfce 0113-2008 HUMAN OTC DRUG sinus congestion Pseudoephedrine HCl TABLET, FILM COATED ORAL 20161004 OTC MONOGRAPH FINAL part341 L. Perrigo Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 0113-2013_61954e87-ff18-4dff-8cb5-a1e665989745 0113-2013 HUMAN OTC DRUG Allergy and Congestion Relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120123 ANDA ANDA076050 L. Perrigo Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 0113-2017_26206f75-648f-47c9-8bad-25127c33961d 0113-2017 HUMAN OTC DRUG sinus 12 hour Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170929 ANDA ANDA075153 L. Perrigo Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 0113-2054_2830cbbc-7309-4dc3-8622-62497e867fe8 0113-2054 HUMAN OTC DRUG 12 hour decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111004 ANDA ANDA075153 L Perrigo Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 0113-2061_5fadb67e-ab7f-4969-8bec-bfc0a987f3ec 0113-2061 HUMAN OTC DRUG tussin mucus plus chest congestion Guaifenesin SOLUTION ORAL 19870715 OTC MONOGRAPH FINAL part341 L. Perrigo Company GUAIFENESIN 200 mg/10mL N 20181231 0113-2141_508478f6-230e-40a0-93f5-428b18cc70ad 0113-2141 HUMAN OTC DRUG Acid Reducer Famotidine TABLET ORAL 20140723 ANDA ANDA075400 L. Perrigo Company FAMOTIDINE 10 mg/1 N 20181231 0113-2176_e3133af3-d804-4f96-8dda-8471927e6565 0113-2176 HUMAN OTC DRUG All Day Allergy-D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20110906 ANDA ANDA077170 L. Perrigo Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 0113-2304_209a0f3c-0f69-4fd0-b3be-4389fd3fda23 0113-2304 HUMAN OTC DRUG Nasal oxymetazoline hydrochloride SPRAY NASAL 19910729 OTC MONOGRAPH FINAL part341 L. Perrigo Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 0113-2365_87ba26c1-f94d-435c-accc-4961a094879d 0113-2365 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20121129 ANDA ANDA091349 L. Perrigo Company NICOTINE 2 mg/1 N 20181231 0113-2417_76544d17-f7f5-4b09-a603-2b754efb6bea 0113-2417 HUMAN OTC DRUG sinus and cold d Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20150129 ANDA ANDA076518 L. Perrigo Company NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 0113-2432_1d6353cb-7515-4e83-bc76-1ff17b699c78 0113-2432 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19870715 OTC MONOGRAPH FINAL part341 L. Perrigo Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 0113-2442_3e13c949-8e79-48e6-9f81-a2780659c4d7 0113-2442 HUMAN OTC DRUG Nicotine Polacrilex Nicotine polacrilex GUM, CHEWING ORAL 20121217 ANDA ANDA091354 L. Perrigo Company NICOTINE 4 mg/1 N 20181231 0113-2476_31bc9a58-c881-4876-b275-94388e512924 0113-2476 HUMAN OTC DRUG Allergy Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20140320 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 0113-4368_de7af512-26a3-4366-b236-c19f6b344a2e 0113-4368 HUMAN OTC DRUG Good Sense Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20140331 ANDA ANDA074661 L. Perrigo Company NAPROXEN SODIUM 220 mg/1 N 20181231 0113-6000_8dee28c9-39c3-48e2-a674-5b7eab92c5e6 0113-6000 HUMAN OTC DRUG Tru Relief Nicotine Nicotine Polacrilex LOZENGE ORAL 20161201 ANDA ANDA203690 L. Perrigo Company NICOTINE 2 mg/1 N 20181231 0113-6001_99884239-f3d6-40f0-a560-076f09cc9840 0113-6001 HUMAN OTC DRUG Tru Relief Nicotine Nicotine Polacrilex LOZENGE ORAL 20161201 ANDA ANDA203690 L. Perrigo Company NICOTINE 4 mg/1 N 20181231 0113-7000_50b761b3-4823-4489-a934-2109cfb2824e 0113-7000 HUMAN OTC DRUG Basic Care acetaminophen Acetaminophen TABLET, FILM COATED ORAL 20170810 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 500 mg/1 N 20181231 0113-7002_edb7c395-f58a-4617-93a6-641923cf398b 0113-7002 HUMAN OTC DRUG Basic Care All Day Allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20170808 ANDA ANDA078336 L. Perrigo Company CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0113-7003_9cf54748-80da-428d-86f1-2a17f1160bc2 0113-7003 HUMAN OTC DRUG Basic Care Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20170903 ANDA ANDA202319 L. Perrigo Company LANSOPRAZOLE 15 mg/1 N 20181231 0113-7029_3528ebe6-eaa1-4714-b251-225c5c097d01 0113-7029 HUMAN OTC DRUG basic care nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170823 ANDA ANDA076775 L. Perrigo Company NICOTINE 2 mg/1 N 20181231 0113-7130_c1a58b40-e9a8-44d5-a5b1-a4b7fd638835 0113-7130 HUMAN OTC DRUG basic care childrens pain and fever Acetaminophen SUSPENSION ORAL 20170808 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL N 20181231 0113-7131_a3cb965c-0e2d-4240-b057-17e5a90eabf9 0113-7131 HUMAN OTC DRUG basic care ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20171010 ANDA ANDA203599 L. Perrigo Company IBUPROFEN 200 mg/1 N 20181231 0113-7170_6dabc17f-8b32-470f-b53d-6f7bede42898 0113-7170 HUMAN OTC DRUG basic care nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170823 ANDA ANDA076789 L. Perrigo Company NICOTINE 4 mg/1 N 20181231 0113-7194_9638abe6-940f-45ea-969a-6afb0120808f 0113-7194 HUMAN OTC DRUG Basic Care famotidine Famotidine TABLET ORAL 20170810 ANDA ANDA077351 L. Perrigo Company FAMOTIDINE 20 mg/1 N 20181231 0113-7199_4f37de98-86f1-4518-a8e5-3decc420ffe6 0113-7199 HUMAN OTC DRUG Basic Care miconazole 1 Miconazole nitrate KIT 20170829 ANDA ANDA079114 L. Perrigo Company N 20181231 0113-7224_35827d82-5b6e-493e-b827-4204d9ddc07b 0113-7224 HUMAN OTC DRUG loperamide hydrochloride Loperamide HCl TABLET, FILM COATED ORAL 20171003 ANDA ANDA075232 L. Perrigo Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 0113-7306_38c95964-ece1-4df3-a2dd-6288637b8bb5 0113-7306 HUMAN OTC DRUG Basic Care Clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20170810 ANDA ANDA090685 L. Perrigo Company POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 0113-7368_3ccdb2b5-3c79-4cb9-a349-cb5c49971d71 0113-7368 HUMAN OTC DRUG Basic Care Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20170913 ANDA ANDA074661 L. Perrigo Company NAPROXEN SODIUM 220 mg/1 N 20181231 0113-7379_8ef6f58b-8d06-4463-95ca-20db741e6984 0113-7379 HUMAN OTC DRUG basic care childrens allergy relief Diphenhydramine HCl SOLUTION ORAL 20170829 OTC MONOGRAPH FINAL part341 L. Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 0113-7401_ab74d236-7745-4b27-8c7b-f49d5009d8af 0113-7401 HUMAN OTC DRUG Basic Care Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20170808 NDA NDA022032 L. Perrigo Company OMEPRAZOLE 20 mg/1 N 20181231 0113-7437_1ffab4f5-da49-4164-b915-3d950d8e911f 0113-7437 HUMAN OTC DRUG basic care acetaminophen PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20171011 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0113-7456_c4aec63b-a04b-449d-af24-14e0ebd5b599 0113-7456 HUMAN OTC DRUG Basic Care nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170808 ANDA ANDA076777 L. Perrigo Company NICOTINE 2 mg/1 N 20181231 0113-7459_019aceee-19ff-42a0-861b-e8811a1027ca 0113-7459 HUMAN OTC DRUG Basic Care Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20170823 OTC MONOGRAPH FINAL part341 L. Perrigo Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 0113-7475_a3958052-7fcc-4663-b94d-186eb0b70a0c 0113-7475 HUMAN OTC DRUG basic care childrens all day allergy Cetirizine HCl SOLUTION ORAL 20170829 ANDA ANDA204226 L. Perrigo Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0113-7479_ab4150c6-e658-4117-bb60-c2140b04ad44 0113-7479 HUMAN OTC DRUG basic care allergy relief Diphenhydramine Hydrochloride TABLET ORAL 20170810 OTC MONOGRAPH FINAL part341 L. Perrigo Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0113-7484_103ddb57-64e4-4855-bce8-67541b796184 0113-7484 HUMAN OTC DRUG basic care acetaminophen Acetaminophen TABLET ORAL 20170808 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 500 mg/1 N 20181231 0113-7489_2a0e0834-c423-47ff-9b39-eaa143259438 0113-7489 HUMAN OTC DRUG basic care antacid Calcium carbonate TABLET, CHEWABLE ORAL 20171003 OTC MONOGRAPH FINAL part331 L. Perrigo Company CALCIUM CARBONATE 750 mg/1 N 20181231 0113-7532_00e5fc31-a7fd-4f87-9154-457489844270 0113-7532 HUMAN OTC DRUG basic care nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170808 ANDA ANDA076779 L. Perrigo Company NICOTINE 4 mg/1 N 20181231 0113-7604_0713e571-98b4-4b7f-88b5-6b245fb5cdc9 0113-7604 HUMAN OTC DRUG Basic Care Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170810 ANDA ANDA072096 L. Perrigo Company IBUPROFEN 200 mg/1 N 20181231 0113-7612_4e285a22-1e5b-44d0-af65-6a993b107fc5 0113-7612 HUMAN OTC DRUG Basic Care allergy relief Loratadine TABLET ORAL 20170824 ANDA ANDA076301 L. Perrigo Company LORATADINE 10 mg/1 N 20181231 0113-7798_f99965af-19b4-4cdf-87f6-80582435f1fe 0113-7798 HUMAN OTC DRUG Basic Care Hair Regrowth Minoxidil SOLUTION TOPICAL 20170810 ANDA ANDA075598 L. Perrigo Company MINOXIDIL 3 g/60mL N 20181231 0113-7852_01f5830a-b18c-41bb-be15-667fbe4d65c5 0113-7852 HUMAN OTC DRUG basic care acid reducer 150 Ranitidine TABLET, FILM COATED ORAL 20170829 ANDA ANDA091429 L. Perrigo Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 0113-7897_97af479b-7d8f-4174-9ad8-abbb6a27efc6 0113-7897 HUMAN OTC DRUG Basic Care childrens ibuprofen Ibuprofen SUSPENSION ORAL 20170810 ANDA ANDA074937 L Perrigo Company IBUPROFEN 100 mg/5mL N 20181231 0113-7915_78507fde-256c-42e9-af3f-bb53024e5b10 0113-7915 HUMAN OTC DRUG Basic Care Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20170808 NDA NDA022032 L. Perrigo Company OMEPRAZOLE 20 mg/1 N 20181231 0113-8442_affb965a-d87b-400e-b73d-3bc02311284f 0113-8442 HUMAN OTC DRUG Good Sense Nicotine Stop Smoking Aid Nicotine polacrilex GUM, CHEWING ORAL 20120119 ANDA ANDA091354 L. Perrigo Company NICOTINE 4 mg/1 N 20181231 0113-8959_d176b93d-f1b8-483d-950f-10aeebb3377a 0113-8959 HUMAN OTC DRUG Good Sense Pain and Fever Acetaminophen SUSPENSION ORAL 20120322 OTC MONOGRAPH NOT FINAL part343 L. Perrigo Company ACETAMINOPHEN 160 mg/5mL N 20181231 0113-9458_93ba9bea-bfbd-4f5a-8ce5-933a79eaa9f6 0113-9458 HUMAN OTC DRUG Good Sense all day allergy Cetirizine Hydrochloride TABLET ORAL 20080116 ANDA ANDA078336 L Perrigo Company CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0115-0511_165c5943-5988-401c-bd3b-be464b3d7975 0115-0511 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Impax Generics FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0115-0522_165c5943-5988-401c-bd3b-be464b3d7975 0115-0522 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Impax Generics FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0115-0533_165c5943-5988-401c-bd3b-be464b3d7975 0115-0533 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Impax Generics FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0115-0671_350eb39e-6072-4467-8f57-ed6edcdbccd8 0115-0671 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET ORAL 20130514 NDA NDA020768 Global Pharmaceuticals, Division of Impax Laboratories Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0115-0672_350eb39e-6072-4467-8f57-ed6edcdbccd8 0115-0672 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET ORAL 20130514 NDA NDA020768 Global Pharmaceuticals, Division of Impax Laboratories Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0115-0691_350eb39e-6072-4467-8f57-ed6edcdbccd8 0115-0691 HUMAN PRESCRIPTION DRUG Zolmitriptan Orally Disintegrating Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130514 NDA NDA021231 Global Pharmaceuticals, Division of Impax Laboratories Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0115-0692_350eb39e-6072-4467-8f57-ed6edcdbccd8 0115-0692 HUMAN PRESCRIPTION DRUG Zolmitriptan Orally Disintegrating Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130514 NDA NDA021231 Global Pharmaceuticals, Division of Impax Laboratories Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0115-1231_934822d9-f3ce-4f77-a429-ad65be1cf65a 0115-1231 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Impax Generics OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1232_934822d9-f3ce-4f77-a429-ad65be1cf65a 0115-1232 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Impax Generics OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1233_934822d9-f3ce-4f77-a429-ad65be1cf65a 0115-1233 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Impax Generics OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1234_934822d9-f3ce-4f77-a429-ad65be1cf65a 0115-1234 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Impax Generics OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1277_a4386238-9625-41a8-9f52-64f29c1e4fce 0115-1277 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20160412 ANDA ANDA200411 Impax Generics MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1278_a4386238-9625-41a8-9f52-64f29c1e4fce 0115-1278 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20160412 ANDA ANDA200411 Impax Generics MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1279_a4386238-9625-41a8-9f52-64f29c1e4fce 0115-1279 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20160412 ANDA ANDA200411 Impax Generics MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1280_a4386238-9625-41a8-9f52-64f29c1e4fce 0115-1280 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20160412 ANDA ANDA200411 Impax Generics MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1281_a4386238-9625-41a8-9f52-64f29c1e4fce 0115-1281 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20160412 ANDA ANDA200411 Impax Generics MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1282_a4386238-9625-41a8-9f52-64f29c1e4fce 0115-1282 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20160412 ANDA ANDA200411 Impax Generics MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1309_b2e9f56b-618b-4d58-b8a7-9de1612f33ce 0115-1309 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate Sevelamer Carbonate TABLET, FILM COATED ORAL 20171023 ANDA ANDA090975 Impax Generics SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0115-1315_934822d9-f3ce-4f77-a429-ad65be1cf65a 0115-1315 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Impax Generics OXYMORPHONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1316_934822d9-f3ce-4f77-a429-ad65be1cf65a 0115-1316 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Impax Generics OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1317_934822d9-f3ce-4f77-a429-ad65be1cf65a 0115-1317 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Impax Generics OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0115-1327_b7aef74c-3a3b-46f2-92c3-44ee62bc74fd 0115-1327 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20110217 ANDA ANDA200065 Impax Generics DOXYCYCLINE 150 mg/1 N 20181231 0115-1328_1584c895-bd1a-4dcb-8764-366cb9660310 0115-1328 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20131217 NDA AUTHORIZED GENERIC NDA021303 Global Pharmaceuticals, Division of Impax Laboratories Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1329_1584c895-bd1a-4dcb-8764-366cb9660310 0115-1329 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20131217 NDA AUTHORIZED GENERIC NDA021303 Global Pharmaceuticals, Division of Impax Laboratories Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1330_1584c895-bd1a-4dcb-8764-366cb9660310 0115-1330 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20131217 NDA AUTHORIZED GENERIC NDA021303 Global Pharmaceuticals, Division of Impax Laboratories Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1331_1584c895-bd1a-4dcb-8764-366cb9660310 0115-1331 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20131217 NDA AUTHORIZED GENERIC NDA021303 Global Pharmaceuticals, Division of Impax Laboratories Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1332_1584c895-bd1a-4dcb-8764-366cb9660310 0115-1332 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20131217 NDA AUTHORIZED GENERIC NDA021303 Global Pharmaceuticals, Division of Impax Laboratories Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1333_1584c895-bd1a-4dcb-8764-366cb9660310 0115-1333 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20131217 NDA AUTHORIZED GENERIC NDA021303 Global Pharmaceuticals, Division of Impax Laboratories Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1385_60aaefd2-4174-400d-b73a-a724eae43a78 0115-1385 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin EZETIMIBE and SIMVASTATIN TABLET, FILM COATED ORAL 20170426 ANDA ANDA201890 Impax Generics EZETIMIBE; SIMVASTATIN 10; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0115-1386_60aaefd2-4174-400d-b73a-a724eae43a78 0115-1386 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin EZETIMIBE and SIMVASTATIN TABLET, FILM COATED ORAL 20170426 ANDA ANDA201890 Impax Generics EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0115-1387_60aaefd2-4174-400d-b73a-a724eae43a78 0115-1387 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin EZETIMIBE and SIMVASTATIN TABLET, FILM COATED ORAL 20170426 ANDA ANDA201890 Impax Generics EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0115-1388_60aaefd2-4174-400d-b73a-a724eae43a78 0115-1388 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin EZETIMIBE and SIMVASTATIN TABLET, FILM COATED ORAL 20170426 ANDA ANDA201890 Impax Generics EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0115-1404_a5528c65-293d-48a7-bb9f-c257c19a75bd 0115-1404 HUMAN PRESCRIPTION DRUG Pyridostigmine Bromide PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE ORAL 20150918 ANDA ANDA203184 Impax Generics PYRIDOSTIGMINE BROMIDE 180 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0115-1408_12e53866-d06b-474a-809e-04b61cc08d02 0115-1408 HUMAN PRESCRIPTION DRUG MethylTESTOSTERone METHYLTESTOSTERONE CAPSULE ORAL 20150921 ANDA ANDA204851 Impax Generics METHYLTESTOSTERONE 10 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0115-1438_67c28dc0-a367-4177-af7d-731eba4ce8f5 0115-1438 HUMAN PRESCRIPTION DRUG Dutasteride Dutasteride CAPSULE, LIQUID FILLED ORAL 20151120 ANDA ANDA200899 Impax Generics DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 0115-1459_6b8d78be-e813-590f-e2d3-95be0f7e9b5c 0115-1459 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20081215 NDA NDA022224 Impax Generics FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0115-1460_6b8d78be-e813-590f-e2d3-95be0f7e9b5c 0115-1460 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20081215 NDA NDA022224 Impax Generics FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0115-1468_60604f72-d2bd-462f-a409-b2431e2b44ad 0115-1468 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20030827 ANDA ANDA076320 Impax Generics LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0115-1474_336cc3fc-ad8e-40b5-8213-711e868d0d9e 0115-1474 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20060713 ANDA ANDA077547 Impax Generics METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0115-1475_d9f1b4da-f817-4bf7-83bf-5bab51efd43e 0115-1475 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene SOLUTION TOPICAL 20091120 ANDA ANDA077029 Impax Generics CALCIPOTRIENE .05 mg/mL Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 0115-1483_988e3d52-d5e0-4dc8-8cea-cd376a91404b 0115-1483 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium GEL TOPICAL 20131121 ANDA ANDA200936 Impax Generics DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0115-1486_b9867044-9a44-4f3b-a9bc-c9c964ad04af 0115-1486 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE ORAL 20160216 ANDA ANDA076852 Impax Generics DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1487_b9867044-9a44-4f3b-a9bc-c9c964ad04af 0115-1487 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE ORAL 20160216 ANDA ANDA076852 Impax Generics DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1488_b9867044-9a44-4f3b-a9bc-c9c964ad04af 0115-1488 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE ORAL 20160216 ANDA ANDA076852 Impax Generics DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1489_b9867044-9a44-4f3b-a9bc-c9c964ad04af 0115-1489 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE ORAL 20160216 ANDA ANDA076852 Impax Generics DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1490_b9867044-9a44-4f3b-a9bc-c9c964ad04af 0115-1490 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE ORAL 20160216 ANDA ANDA076852 Impax Generics DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1491_b9867044-9a44-4f3b-a9bc-c9c964ad04af 0115-1491 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE ORAL 20160216 ANDA ANDA076852 Impax Generics DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1512_43c22af8-91be-4605-8bbc-3f84bab89e01 0115-1512 HUMAN PRESCRIPTION DRUG NAFTIFINE HYDROCHLORIDE NAFTIFINE HYDROCHLORIDE CREAM TOPICAL 20170510 ANDA ANDA206960 Impax Generics NAFTIFINE HYDROCHLORIDE 20 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 0115-1517_334c8c8d-61e2-490c-8cdb-12a280ffec39 0115-1517 HUMAN PRESCRIPTION DRUG Desonide Desonide LOTION TOPICAL 20171218 ANDA ANDA072354 Impax Generics DESONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0115-1522_574b923a-b243-4ef5-9d1f-763ec875fa60 0115-1522 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20150624 NDA AUTHORIZED GENERIC NDA022118 Impax Generics FENOFIBRATE 40 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0115-1523_574b923a-b243-4ef5-9d1f-763ec875fa60 0115-1523 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20150624 NDA AUTHORIZED GENERIC NDA022118 Impax Generics FENOFIBRATE 120 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0115-1524_96956613-a537-44f3-903e-a7dac011c1e8 0115-1524 HUMAN PRESCRIPTION DRUG URSODIOL URSODIOL TABLET, FILM COATED ORAL 20111223 ANDA ANDA200826 Impax Generics URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 0115-1525_96956613-a537-44f3-903e-a7dac011c1e8 0115-1525 HUMAN PRESCRIPTION DRUG URSODIOL URSODIOL TABLET, FILM COATED ORAL 20111223 ANDA ANDA200826 Impax Generics URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 0115-1526_3f972740-00d3-4124-a790-6ddba9f7cda5 0115-1526 HUMAN PRESCRIPTION DRUG Lamotrigine LAMOTRIGINE TABLET, ORALLY DISINTEGRATING ORAL 20150109 ANDA ANDA200828 Impax Generics LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0115-1527_3f972740-00d3-4124-a790-6ddba9f7cda5 0115-1527 HUMAN PRESCRIPTION DRUG Lamotrigine LAMOTRIGINE TABLET, ORALLY DISINTEGRATING ORAL 20150109 ANDA ANDA200828 Impax Generics LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0115-1528_3f972740-00d3-4124-a790-6ddba9f7cda5 0115-1528 HUMAN PRESCRIPTION DRUG Lamotrigine LAMOTRIGINE TABLET, ORALLY DISINTEGRATING ORAL 20150109 ANDA ANDA200828 Impax Generics LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0115-1529_3f972740-00d3-4124-a790-6ddba9f7cda5 0115-1529 HUMAN PRESCRIPTION DRUG Lamotrigine LAMOTRIGINE TABLET, ORALLY DISINTEGRATING ORAL 20150109 ANDA ANDA200828 Impax Generics LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0115-1554_6b8d78be-e813-590f-e2d3-95be0f7e9b5c 0115-1554 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20160912 NDA NDA022224 Impax Generics FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0115-1555_6b8d78be-e813-590f-e2d3-95be0f7e9b5c 0115-1555 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20160912 NDA NDA022224 Impax Generics FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0115-1556_223a6507-4548-460f-a4f4-b63b5bdf71d2 0115-1556 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160222 NDA AUTHORIZED GENERIC NDA022272 Impax Generics OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0115-1557_223a6507-4548-460f-a4f4-b63b5bdf71d2 0115-1557 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160222 NDA AUTHORIZED GENERIC NDA022272 Impax Generics OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0115-1558_223a6507-4548-460f-a4f4-b63b5bdf71d2 0115-1558 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160222 NDA AUTHORIZED GENERIC NDA022272 Impax Generics OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0115-1559_223a6507-4548-460f-a4f4-b63b5bdf71d2 0115-1559 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160222 NDA AUTHORIZED GENERIC NDA022272 Impax Generics OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0115-1560_223a6507-4548-460f-a4f4-b63b5bdf71d2 0115-1560 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160222 NDA AUTHORIZED GENERIC NDA022272 Impax Generics OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0115-1561_223a6507-4548-460f-a4f4-b63b5bdf71d2 0115-1561 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160222 NDA AUTHORIZED GENERIC NDA022272 Impax Generics OXYCODONE HYDROCHLORIDE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0115-1562_223a6507-4548-460f-a4f4-b63b5bdf71d2 0115-1562 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160222 NDA AUTHORIZED GENERIC NDA022272 Impax Generics OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0115-1643_5ac6c7b1-53ab-46a0-b738-8e2a15a3a86e 0115-1643 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20070308 ANDA ANDA073671 Impax Generics NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0115-1645_5ac6c7b1-53ab-46a0-b738-8e2a15a3a86e 0115-1645 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20070308 ANDA ANDA073652 Impax Generics NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0115-1646_92a46ce2-3548-40e1-add9-fb4239000672 0115-1646 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20060127 ANDA ANDA077122 Impax Generics DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] E 20171231 0115-1647_92a46ce2-3548-40e1-add9-fb4239000672 0115-1647 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20060127 ANDA ANDA077122 Impax Generics DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] E 20171231 0115-1648_43a1fabd-7f63-429a-825b-0b91034e52e5 0115-1648 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20160803 ANDA ANDA076716 Impax Generics GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0115-1649_43a1fabd-7f63-429a-825b-0b91034e52e5 0115-1649 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20160803 ANDA ANDA076716 Impax Generics GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0115-1650_43a1fabd-7f63-429a-825b-0b91034e52e5 0115-1650 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20160803 ANDA ANDA076716 Impax Generics GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0115-1651_b58dc83d-544b-41f9-8457-e60069b6f39c 0115-1651 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 Impax Generics METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0115-1652_b58dc83d-544b-41f9-8457-e60069b6f39c 0115-1652 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA072750 Impax Generics METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0115-1653_204d5fb6-11e0-4867-8660-e91b1d1b1839 0115-1653 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20161101 ANDA ANDA076307 Impax Generics MIRTAZAPINE 15 mg/1 N 20181231 0115-1654_204d5fb6-11e0-4867-8660-e91b1d1b1839 0115-1654 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20161101 ANDA ANDA076307 Impax Generics MIRTAZAPINE 30 mg/1 N 20181231 0115-1656_204d5fb6-11e0-4867-8660-e91b1d1b1839 0115-1656 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20161101 ANDA ANDA076307 Impax Generics MIRTAZAPINE 45 mg/1 N 20181231 0115-1657_2ff9e73d-1ab0-43d7-ae7b-8f8dd1bedfd8 0115-1657 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20010820 ANDA ANDA075189 Impax Generics NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0115-1658_2ff9e73d-1ab0-43d7-ae7b-8f8dd1bedfd8 0115-1658 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20010926 ANDA ANDA075189 Impax Generics NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0115-1659_09179711-29ba-4afe-b0e6-38d40778df07 0115-1659 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20160919 ANDA ANDA070175 Impax Generics PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0115-1660_09179711-29ba-4afe-b0e6-38d40778df07 0115-1660 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20160919 ANDA ANDA070176 Impax Generics PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0115-1661_09179711-29ba-4afe-b0e6-38d40778df07 0115-1661 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20160919 ANDA ANDA070177 Impax Generics PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0115-1662_09179711-29ba-4afe-b0e6-38d40778df07 0115-1662 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20160919 ANDA ANDA070178 Impax Generics PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0115-1667_0c72486f-de6b-46dd-a35b-0f8d7240361e 0115-1667 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20160104 20190831 ANDA ANDA202552 Impax Generics ACITRETIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0115-1668_0c72486f-de6b-46dd-a35b-0f8d7240361e 0115-1668 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20160104 20190831 ANDA ANDA202552 Impax Generics ACITRETIN 17.5 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0115-1669_0c72486f-de6b-46dd-a35b-0f8d7240361e 0115-1669 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20160104 20190831 ANDA ANDA202552 Impax Generics ACITRETIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0115-1670_eda69b2d-2498-431e-a27b-dac0367b348d 0115-1670 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Impax Generics HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0115-1671_eda69b2d-2498-431e-a27b-dac0367b348d 0115-1671 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960615 ANDA ANDA040156 Impax Generics HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0115-1672_13d4a8b4-7ac2-48f1-b501-c1460199c629 0115-1672 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20130315 ANDA ANDA077756 Impax Generics LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0115-1673_13d4a8b4-7ac2-48f1-b501-c1460199c629 0115-1673 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20130315 ANDA ANDA077756 Impax Generics LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0115-1674_13d4a8b4-7ac2-48f1-b501-c1460199c629 0115-1674 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20130315 ANDA ANDA077756 Impax Generics LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0115-1675_7ca790ea-ce16-4833-affe-114b9823c3b6 0115-1675 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION INTRAVENOUS 20160921 ANDA ANDA065445 Impax Generics EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0115-1676_d1bf742e-5ce9-4ab9-81a3-c5de115d6310 0115-1676 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Impax Generics ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 0115-1678_d1bf742e-5ce9-4ab9-81a3-c5de115d6310 0115-1678 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Impax Generics ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 0115-1679_d1bf742e-5ce9-4ab9-81a3-c5de115d6310 0115-1679 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Impax Generics ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 0115-1680_d1bf742e-5ce9-4ab9-81a3-c5de115d6310 0115-1680 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Impax Generics ALENDRONATE SODIUM 40 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 0115-1681_d1bf742e-5ce9-4ab9-81a3-c5de115d6310 0115-1681 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Impax Generics ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 0115-1682_899473eb-b915-44b2-a6d4-dc24c5c6aa85 0115-1682 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150806 ANDA ANDA079108 Impax Generics DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1683_899473eb-b915-44b2-a6d4-dc24c5c6aa85 0115-1683 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150806 ANDA ANDA079108 Impax Generics DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1684_899473eb-b915-44b2-a6d4-dc24c5c6aa85 0115-1684 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141111 ANDA ANDA079108 Impax Generics DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1685_899473eb-b915-44b2-a6d4-dc24c5c6aa85 0115-1685 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20151221 ANDA ANDA079108 Impax Generics DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1686_899473eb-b915-44b2-a6d4-dc24c5c6aa85 0115-1686 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140224 ANDA ANDA079108 Impax Generics DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1687_5edb1920-0ead-45ed-b52e-6856f5430591 0115-1687 HUMAN PRESCRIPTION DRUG Budesonide Inhalation Budesonide SUSPENSION RESPIRATORY (INHALATION) 20160804 ANDA ANDA078404 Impax Generics BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0115-1689_5edb1920-0ead-45ed-b52e-6856f5430591 0115-1689 HUMAN PRESCRIPTION DRUG Budesonide Inhalation Budesonide SUSPENSION RESPIRATORY (INHALATION) 20160804 ANDA ANDA078404 Impax Generics BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0115-1690_17c5f9f0-e406-4d06-861d-c838f904ee79 0115-1690 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20161101 ANDA ANDA074253 Impax Generics BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 0115-1691_17c5f9f0-e406-4d06-861d-c838f904ee79 0115-1691 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20161101 ANDA ANDA074253 Impax Generics BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 0115-1692_17c5f9f0-e406-4d06-861d-c838f904ee79 0115-1692 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20161101 ANDA ANDA074253 Impax Generics BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 0115-1693_e46c4ac5-5d33-4bb7-8c0f-d74c3adc5b24 0115-1693 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071975 Impax Generics PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0115-1694_53a6908e-0b21-47e8-b0b1-0f8fbfb3124e 0115-1694 HUMAN PRESCRIPTION DRUG epinephrine epinephrine INJECTION SUBCUTANEOUS 20100401 NDA AUTHORIZED GENERIC NDA020800 Impax Generics EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0115-1695_53a6908e-0b21-47e8-b0b1-0f8fbfb3124e 0115-1695 HUMAN PRESCRIPTION DRUG epinephrine epinephrine INJECTION SUBCUTANEOUS 20100401 NDA AUTHORIZED GENERIC NDA020800 Impax Generics EPINEPHRINE .15 mg/.15mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0115-1696_1615e977-04b7-49e6-9643-fb5ffbeb7bb5 0115-1696 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20070330 ANDA ANDA040646 Impax Generics HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0115-1697_1615e977-04b7-49e6-9643-fb5ffbeb7bb5 0115-1697 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20070330 ANDA ANDA040646 Impax Generics HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0115-1698_0c72486f-de6b-46dd-a35b-0f8d7240361e 0115-1698 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20160104 ANDA ANDA202552 Impax Generics ACITRETIN 22.5 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0115-1700_1615e977-04b7-49e6-9643-fb5ffbeb7bb5 0115-1700 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20070330 ANDA ANDA040646 Impax Generics HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0115-1702_6301d0f3-fb67-4a63-bf16-845c76a5b4a0 0115-1702 HUMAN PRESCRIPTION DRUG Dextroamphetamine SulfateExtended-Release Extended-Release Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA AUTHORIZED GENERIC NDA017078 Impax Generics DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1703_6301d0f3-fb67-4a63-bf16-845c76a5b4a0 0115-1703 HUMAN PRESCRIPTION DRUG Dextroamphetamine SulfateExtended-Release Extended-Release Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA AUTHORIZED GENERIC NDA017078 Impax Generics DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1704_6301d0f3-fb67-4a63-bf16-845c76a5b4a0 0115-1704 HUMAN PRESCRIPTION DRUG Dextroamphetamine SulfateExtended-Release Extended-Release Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA AUTHORIZED GENERIC NDA017078 Impax Generics DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1705_bd2b28a4-dcd0-4af0-a2e9-1273aef02228 0115-1705 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20160321 ANDA ANDA074204 Impax Generics FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0115-1706_bd2b28a4-dcd0-4af0-a2e9-1273aef02228 0115-1706 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20160321 ANDA ANDA074204 Impax Generics FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0115-1707_bd2b28a4-dcd0-4af0-a2e9-1273aef02228 0115-1707 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20160321 ANDA ANDA074204 Impax Generics FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0115-1709_d46a6458-6701-40ae-b8ac-544c48f52ba4 0115-1709 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170705 ANDA ANDA203614 Impax Generics DEXMETHYLPHENIDATE HYDROCHLORIDE 25 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1710_d46a6458-6701-40ae-b8ac-544c48f52ba4 0115-1710 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170705 ANDA ANDA203614 Impax Generics DEXMETHYLPHENIDATE HYDROCHLORIDE 35 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0115-1711_57150d16-7ee0-470e-a96b-a4e6e92d3c8d 0115-1711 HUMAN PRESCRIPTION DRUG aspirin and dipyridamole aspirin and dipyridamole CAPSULE, EXTENDED RELEASE ORAL 20160829 ANDA ANDA206964 Impax Generics ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0115-1736_e8e8de1e-c86d-48a3-a56d-8f1dfc8c1cd7 0115-1736 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160920 ANDA ANDA205105 Impax Generics METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20191231 0115-1737_e8e8de1e-c86d-48a3-a56d-8f1dfc8c1cd7 0115-1737 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160920 ANDA ANDA205105 Impax Generics METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20191231 0115-1738_e8e8de1e-c86d-48a3-a56d-8f1dfc8c1cd7 0115-1738 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160920 ANDA ANDA205105 Impax Generics METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20191231 0115-1739_e8e8de1e-c86d-48a3-a56d-8f1dfc8c1cd7 0115-1739 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160920 ANDA ANDA205105 Impax Generics METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20191231 0115-1740_e8e8de1e-c86d-48a3-a56d-8f1dfc8c1cd7 0115-1740 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160920 ANDA ANDA205105 Impax Generics METHYLPHENIDATE HYDROCHLORIDE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20191231 0115-1741_e8e8de1e-c86d-48a3-a56d-8f1dfc8c1cd7 0115-1741 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160920 ANDA ANDA205105 Impax Generics METHYLPHENIDATE HYDROCHLORIDE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20191231 0115-1746_eb7aca58-77c1-4bc3-b9e7-e5fcddee3afe 0115-1746 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20170306 ANDA ANDA202284 Impax Generics FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0115-1747_eb7aca58-77c1-4bc3-b9e7-e5fcddee3afe 0115-1747 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20170306 ANDA ANDA202284 Impax Generics FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0115-1750_7f7f7996-83f9-48fe-b63f-96139a75b648 0115-1750 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20160104 ANDA ANDA202552 Impax Generics ACITRETIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0115-1751_7f7f7996-83f9-48fe-b63f-96139a75b648 0115-1751 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20160104 ANDA ANDA202552 Impax Generics ACITRETIN 17.5 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0115-1752_7f7f7996-83f9-48fe-b63f-96139a75b648 0115-1752 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20160104 ANDA ANDA202552 Impax Generics ACITRETIN 22.5 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0115-1753_7f7f7996-83f9-48fe-b63f-96139a75b648 0115-1753 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20160104 ANDA ANDA202552 Impax Generics ACITRETIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0115-1754_842d53e7-fc46-48e4-bda9-fc0a856924ef 0115-1754 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20030701 ANDA ANDA076411 Impax Generics METHENAMINE HIPPURATE 1 g/1 N 20191231 0115-1911_68214c8d-3c04-45f2-9272-c9a3a576c296 0115-1911 HUMAN PRESCRIPTION DRUG Rimantadine Hydrochloride Rimantadine Hydrochloride TABLET, FILM COATED ORAL 20050401 ANDA ANDA076132 Impax Generics RIMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 0115-2011_3ac69a4e-b8de-490a-85d6-4d384e9ee040 0115-2011 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 20000623 ANDA ANDA040368 Impax Generics ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0115-2611_c17e3f6d-cfe4-48a1-bc11-d0696a529804 0115-2611 HUMAN PRESCRIPTION DRUG TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET ORAL 20010626 ANDA ANDA075877 Impax Generics TERBUTALINE SULFATE 2.5 mg/1 N 20181231 0115-2622_c17e3f6d-cfe4-48a1-bc11-d0696a529804 0115-2622 HUMAN PRESCRIPTION DRUG TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET ORAL 20010626 ANDA ANDA075877 Impax Generics TERBUTALINE SULFATE 5 mg/1 N 20181231 0115-3511_6ef61835-6dab-4c9e-91e5-726fb6e8627c 0115-3511 HUMAN PRESCRIPTION DRUG Pyridostigmine Bromide PYRIDOSTIGMINE BROMIDE TABLET ORAL 20030424 ANDA ANDA040502 Impax Generics PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0115-4211_6adc2229-0675-45c0-b10d-10565489b80e 0115-4211 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20040527 ANDA ANDA076449 Impax Generics MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0115-4222_6adc2229-0675-45c0-b10d-10565489b80e 0115-4222 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20040527 ANDA ANDA076449 Impax Generics MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0115-4233_6adc2229-0675-45c0-b10d-10565489b80e 0115-4233 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20051216 ANDA ANDA076449 Impax Generics MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0115-4411_6977dc71-3e7f-448e-9b5c-96128612c66f 0115-4411 HUMAN PRESCRIPTION DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL 20050301 ANDA ANDA076856 Impax Generics DANTROLENE SODIUM 25 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 0115-4422_6977dc71-3e7f-448e-9b5c-96128612c66f 0115-4422 HUMAN PRESCRIPTION DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL 20050301 ANDA ANDA076856 Impax Generics DANTROLENE SODIUM 50 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 0115-4433_6977dc71-3e7f-448e-9b5c-96128612c66f 0115-4433 HUMAN PRESCRIPTION DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL 20050301 ANDA ANDA076856 Impax Generics DANTROLENE SODIUM 100 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 0115-5211_6ca54ede-bcf9-4efa-917f-0028023b9718 0115-5211 HUMAN PRESCRIPTION DRUG COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20061024 ANDA ANDA077510 Impax Generics COLESTIPOL HYDROCHLORIDE 1 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 0115-5212_32902ffc-8712-434f-932f-f2f1067a3eee 0115-5212 HUMAN PRESCRIPTION DRUG COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE SUSPENSION ORAL 20060502 ANDA ANDA077277 Impax Generics COLESTIPOL HYDROCHLORIDE 5 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 0115-5213_32902ffc-8712-434f-932f-f2f1067a3eee 0115-5213 HUMAN PRESCRIPTION DRUG COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE SUSPENSION ORAL 20060502 ANDA ANDA077277 Impax Generics COLESTIPOL HYDROCHLORIDE 5 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 0115-5311_2669933a-33f4-478a-bd9d-9fe48429bcc9 0115-5311 HUMAN PRESCRIPTION DRUG Nadolol and Bendroflumethiazide NADOLOL and BENDROFLUMETHIAZIDE TABLET ORAL 20070330 ANDA ANDA077833 Impax Generics NADOLOL; BENDROFLUMETHIAZIDE 40; 5 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0115-5322_2669933a-33f4-478a-bd9d-9fe48429bcc9 0115-5322 HUMAN PRESCRIPTION DRUG Nadolol and Bendroflumethiazide NADOLOL and BENDROFLUMETHIAZIDE TABLET ORAL 20070330 ANDA ANDA077833 Impax Generics NADOLOL; BENDROFLUMETHIAZIDE 80; 5 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0115-5445_a6a407f4-8f27-4ddc-bd62-1a846a530320 0115-5445 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041203 ANDA ANDA076711 Impax Generics BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0115-5511_4e0582a9-c13a-45a7-86dc-bec66cb37e45 0115-5511 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Impax Generics FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0115-5522_4e0582a9-c13a-45a7-86dc-bec66cb37e45 0115-5522 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Impax Generics FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0115-5922_753c03a9-efb4-4bf5-8827-106f03441475 0115-5922 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20070501 ANDA ANDA077248 Impax Generics PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 0115-6811_6bb54256-9b5f-413b-a2ca-8a4babd7cc90 0115-6811 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090501 ANDA ANDA077415 Impax Generics BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0115-6911_3037cfb8-a2ba-41b3-adb6-a6aae025ae05 0115-6911 HUMAN PRESCRIPTION DRUG Divalproex Sodium DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078791 Impax Generics DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0115-6922_3037cfb8-a2ba-41b3-adb6-a6aae025ae05 0115-6922 HUMAN PRESCRIPTION DRUG Divalproex Sodium DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078791 Impax Generics DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0115-7033_9d59b090-8ff9-4fd1-8b57-8cfa8edc91c5 0115-7033 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate FLUDROCORTISONE ACETATE TABLET ORAL 20020318 ANDA ANDA040431 Impax Generics FLUDROCORTISONE ACETATE .1 mg/1 N 20181231 0115-7037_953a7a5e-cc16-454e-8f91-30d3b719b73d 0115-7037 HUMAN PRESCRIPTION DRUG METHITEST METHYLTESTOSTERONE TABLET ORAL 19741017 ANDA ANDA080767 Impax Generics METHYLTESTOSTERONE 10 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0115-9811_eaa09a12-c111-4a46-bf55-efddcae16d27 0115-9811 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20090720 ANDA ANDA078556 Impax Generics DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0115-9822_eaa09a12-c111-4a46-bf55-efddcae16d27 0115-9822 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20090720 ANDA ANDA078556 Impax Generics DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0115-9935_65351e02-ba65-4ae9-a131-f8c99b9401b8 0115-9935 HUMAN PRESCRIPTION DRUG minocycline hydrochloride minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090723 NDA AUTHORIZED GENERIC NDA050808 Impax Generics MINOCYCLINE HYDROCHLORIDE 65 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0115-9936_65351e02-ba65-4ae9-a131-f8c99b9401b8 0115-9936 HUMAN PRESCRIPTION DRUG minocycline hydrochloride minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090723 NDA AUTHORIZED GENERIC NDA050808 Impax Generics MINOCYCLINE HYDROCHLORIDE 115 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0116-1021_5c4d5f2c-4bb9-fd95-e053-2a91aa0ae816 0116-1021 HUMAN OTC DRUG DYNA-HEX 2 Chlorhexidine gluconate LIQUID TOPICAL 20140101 NDA NDA019422 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE 2 g/100mL N 20181231 0116-1022_36e6abcb-d793-3ef4-e054-00144ff8d46c 0116-1022 HUMAN OTC DRUG Dyna-Hex 2 Chlorhexidine Gluconate 2% SOLUTION TOPICAL 20160129 NDA NDA019422 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE 20 mg/mL N 20181231 0116-1060_245c41e6-a0f7-0825-e054-00144ff8d46c 0116-1060 HUMAN OTC DRUG DYNA-HEX 4 Chlorhexidine Gluconate LIQUID TOPICAL 20160101 NDA NDA019125 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE 4 g/100mL N 20181231 0116-1061_5d071fbf-da6e-0901-e053-2a91aa0a16f8 0116-1061 HUMAN OTC DRUG ANTISEPTIC SKIN CLEANSER CHLORHEXIDINE GLUCONATE SOLUTION TOPICAL 20110831 NDA NDA019125 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE 4 g/100mL N 20181231 0116-2001_5bbfca01-9327-c2cf-e053-2991aa0aa57f 0116-2001 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20100601 ANDA ANDA077789 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 0116-2992_22cb565d-eafa-3271-e054-00144ff88e88 0116-2992 HUMAN OTC DRUG Scrub Care Exidine-2 CHG CHLORHEXIDINE GLUCONATE SOLUTION TOPICAL 20100501 NDA NDA019422 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE 2 g/100mL N 20181231 0116-2994_17253827-2b21-2f9f-e054-00144ff8d46c 0116-2994 HUMAN OTC DRUG Scrub Care Exidine -4 CHG Chlorhexidine Gluconate LIQUID TOPICAL 20121101 NDA NDA019125 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE 4 mg/100mL N 20181231 0116-2994_172573c4-7dbb-3058-e054-00144ff8d46c 0116-2994 HUMAN OTC DRUG Scrub Care Exidine -4 CHG Chlorhexidine gluconate LIQUID TOPICAL 20121101 NDA NDA019125 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE 4 mg/100mL N 20181231 0116-4242_22cb565d-eae9-3271-e054-00144ff88e88 0116-4242 HUMAN OTC DRUG Scrub Care Exidine-2 CHG CHLORHEXIDINE GLUCONATE SOLUTION TOPICAL 20100501 NDA NDA019422 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE 2 g/100mL N 20181231 0116-4444_1716622b-18c1-5807-e054-00144ff8d46c 0116-4444 HUMAN OTC DRUG Scrub Care Exidine -4 CHG Chlorhexidine gluconate LIQUID TOPICAL 20121101 NDA NDA019125 Xttrium Laboratories, Inc. CHLORHEXIDINE GLUCONATE 4 mg/100mL N 20181231 0121-0431_101a578b-aab6-4fce-9c90-d184dd9fd441 0121-0431 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide SUSPENSION ORAL 19790904 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. MAGNESIUM HYDROXIDE 400 mg/5mL N 20181231 0121-0489_5a1ef815-2b6b-52d5-e053-2991aa0a85cb 0121-0489 HUMAN PRESCRIPTION DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 19820210 ANDA ANDA087513 Pharmaceutical Associates, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0121-0504_602b1755-9704-7781-e053-2a91aa0ad854 0121-0504 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEINE PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA087508 Pharmaceutical Associates, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 0121-0527_7e639f77-1e43-45cf-a585-8e7ffa1784c5 0121-0527 HUMAN OTC DRUG MILK OF MAGNESIA MAGNESIUM HYDROXIDE SUSPENSION ORAL 19820420 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. MAGNESIUM HYDROXIDE 2400 mg/10mL N 20181231 0121-0544_6e110482-13f6-44c9-9856-54406019808f 0121-0544 HUMAN OTC DRUG Docusate Sodium Docusate Sodium LIQUID ORAL 19830216 OTC MONOGRAPH NOT FINAL part334 Pharmaceutical Associates, Inc. DOCUSATE SODIUM 50 mg/5mL N 20181231 0121-0547_f42373cd-3894-4b6f-8995-c45f96e931cb 0121-0547 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP ORAL 19881222 ANDA ANDA089647 Pharmaceutical Associates, Inc. PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 0121-0576_602b2124-a88a-0bd0-e053-2a91aa0a7acc 0121-0576 HUMAN PRESCRIPTION DRUG Metoclopramide metoclopramide hydrochloride SOLUTION ORAL 19910601 ANDA ANDA072744 Pharmaceutical Associates, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0121-0577_5436a0ac-dd6c-4a34-e054-00144ff88e88 0121-0577 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 19660730 ANDA ANDA074623 Pharmaceutical Associates, Inc, LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 0121-0581_5f39bd7b-4ead-09df-e053-2a91aa0a9638 0121-0581 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol SOLUTION ORAL 20091110 ANDA ANDA073037 Pharmaceutical Associates, Inc. HALOPERIDOL 2 mg/mL Typical Antipsychotic [EPC] N 20181231 0121-0595_4bd10bd0-f555-11cd-e054-00144ff88e88 0121-0595 HUMAN PRESCRIPTION DRUG Sodium Citrate and Citric Acid SODIUM CITRATE and CITRIC ACID MONOHYDRATE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Pharmaceutical Associates, Inc. SODIUM CITRATE; ANHYDROUS CITRIC ACID 500; 334 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0121-0638_4b481e49-7547-3345-e054-00144ff8d46c 0121-0638 HUMAN OTC DRUG GUAIFENESIN DM GUAIFENESIN and DEXTROMETHORPHAN SYRUP ORAL 19920701 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN; DEXTROMETHORPHAN 100; 10 mg/5mL; mg/5mL N 20181231 0121-0646_1be36e11-a560-4ca5-a9b1-1c002ee996ad 0121-0646 HUMAN PRESCRIPTION DRUG AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE SOLUTION ORAL 19950717 ANDA ANDA074509 Pharmaceutical Associates, Inc. AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 0121-0653_60a597cb-33e0-6528-e053-2a91aa0a95be 0121-0653 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride SOLUTION, CONCENTRATE ORAL 20100901 ANDA ANDA074725 Pharmaceutical Associates, Inc. FLUPHENAZINE HYDROCHLORIDE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 0121-0654_0b3aed8d-63fb-4b7f-8fec-a2d7aa0a3d6b 0121-0654 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride ELIXIR ORAL 20100831 ANDA ANDA040146 Pharmaceutical Associates, Inc. FLUPHENAZINE HYDROCHLORIDE .5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0121-0657_4b472494-2979-53fd-e054-00144ff88e88 0121-0657 HUMAN OTC DRUG Acetaminophen Acetaminophen SOLUTION ORAL 20070801 OTC MONOGRAPH NOT FINAL part343 Pharmaceutical Associates, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 0121-0658_bc83a315-b1dd-44ba-80e4-5f0beae2fb30 0121-0658 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride SOLUTION ORAL 19970515 ANDA ANDA040177 Pharmaceutical Associates, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/5mL E 20171231 0121-0670_92a08a29-d0a7-42a6-8fd5-0d53e70f0071 0121-0670 HUMAN PRESCRIPTION DRUG ETHOSUXIMIDE ETHOSUXIMIDE SOLUTION ORAL 20001122 ANDA ANDA040253 Pharmaceutical Associates, Inc. ETHOSUXIMIDE 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0121-0671_2000b665-7d6f-415b-b9d5-d4eca54a241b 0121-0671 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE SYRUP ORAL 19981218 ANDA ANDA075137 Pharmaceutical Associates, Inc. OXYBUTYNIN CHLORIDE 5 mg/5mL Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0121-0675_5f37fcae-3eee-29b5-e053-2a91aa0a70c2 0121-0675 HUMAN PRESCRIPTION DRUG VALPROIC ACID VALPROIC ACID SOLUTION ORAL 20050411 ANDA ANDA075379 Pharmaceutical Associates, Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0121-0676_55cfc14e-f229-0a89-e054-00144ff88e88 0121-0676 HUMAN PRESCRIPTION DRUG Potassium Citrate and Citric Acid Potassium Citrate and Citric Acid Monohydrate SOLUTION ORAL 19971007 UNAPPROVED DRUG OTHER Pharmaceutical Associates, Inc. POTASSIUM CITRATE; CITRIC ACID MONOHYDRATE 1100; 334 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0121-0677_57e16fd9-afb8-498f-9c46-ebd46cfaedc4 0121-0677 HUMAN PRESCRIPTION DRUG TRICITRATES POTASSIUM CITRATE, SODIUM CITRATE, and CITRIC ACID MONOHYDRATE SOLUTION ORAL 20050525 UNAPPROVED DRUG OTHER Pharmaceutical Associates, Inc. POTASSIUM CITRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE 550; 500; 334 mg/5mL; mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0121-0678_314ef176-c869-426a-8bbd-30c147eecafa 0121-0678 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride SOLUTION ORAL 20000823 ANDA ANDA075606 Pharmaceutical Associates, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/5mL Tricyclic Antidepressant [EPC] N 20181231 0121-0721_517b83d8-454f-166c-e054-00144ff88e88 0121-0721 HUMAN PRESCRIPTION DRUG Fluoxetine FLUOXETINE HYDROCHLORIDE SOLUTION ORAL 20020130 ANDA ANDA076015 Pharmaceutical Associates, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0121-0727_506a5144-f5ca-4eab-9cc9-e5dfa2a38b4e 0121-0727 HUMAN PRESCRIPTION DRUG Ranitidine RANITIDINE SYRUP ORAL 20101101 ANDA ANDA077405 Pharmaceutical Associates, Inc. RANITIDINE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0121-0744_63f0e37d-e6e4-dec5-e053-2991aa0a2244 0121-0744 HUMAN OTC DRUG GUAIFENESIN GUAIFENESIN SOLUTION ORAL 20020901 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN 100 mg/5mL N 20191231 0121-0747_62e527b0-7983-a571-e053-2991aa0a140e 0121-0747 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate SUSPENSION ORAL 20091119 NDA NDA019183 Pharmaceutical Associates, Inc. SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20191231 0121-0759_3aaa91d4-15ae-41e4-bb5e-4f6d315c4452 0121-0759 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20050425 ANDA ANDA076913 Pharmaceutical Associates, Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0121-0766_c2bfaeaa-1ed1-46e5-84b2-3a20c46eb9f4 0121-0766 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate SUSPENSION ORAL 20041201 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. CALCIUM CARBONATE 1250 mg/5mL N 20181231 0121-0770_625f6d61-e71e-0e15-e053-2991aa0af53c 0121-0770 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam LIQUID ORAL 20101101 ANDA ANDA090260 Pharmaceutical Associates, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0121-0772_4b47f3d3-a59b-5a4e-e054-00144ff8d46c 0121-0772 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20130729 ANDA ANDA040838 Pharmaceutical Associates, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0121-0773_47951df4-1238-2217-e054-00144ff88e88 0121-0773 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20170131 ANDA ANDA078465 Pharmaceutical Associates, Inc. PREDNISOLONE SODIUM PHOSPHATE 10 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0121-0775_60a55dbd-cba5-3f21-e053-2991aa0a66c7 0121-0775 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN; CODEINE PHOSPHATE 100; 10 mg/5mL; mg/5mL CV N 20181231 0121-0777_4794f1b6-0bc7-56cc-e054-00144ff8d46c 0121-0777 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20170131 ANDA ANDA078988 Pharmaceutical Associates, Inc. PREDNISOLONE SODIUM PHOSPHATE 20 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0121-0788_fc72c9e4-1bc6-4d5c-b4e9-ca85e11dc8ba 0121-0788 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE CYPROHEPTADINE SYRUP ORAL 20130729 ANDA ANDA091295 Pharmaceutical Associates, Inc. CYPROHEPTADINE 2 mg/5mL E 20171231 0121-0799_5f390f7d-cdd5-d745-e053-2991aa0a46da 0121-0799 HUMAN PRESCRIPTION DRUG Levetiracetam LEVETIRACETAM SOLUTION ORAL 20150604 ANDA ANDA201157 Pharmaceutical Associates, Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0121-0809_58f894c7-263c-433a-af8d-7073c7079917 0121-0809 HUMAN OTC DRUG Guaifenesin DM GUAIFENESIN and DEXTROMETHORPHAN SOLUTION ORAL 20100517 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN; DEXTROMETHORPHAN 200; 10 mg/5mL; mg/5mL E 20171231 0121-0810_4b481e49-755d-3345-e054-00144ff8d46c 0121-0810 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20160201 ANDA ANDA203621 Pharmaceutical Associates, Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0121-0820_504d4800-cb3f-1148-e054-00144ff88e88 0121-0820 HUMAN PRESCRIPTION DRUG THEOPHYLLINE THEOPHYLLINE SOLUTION ORAL 20161216 ANDA ANDA206344 Pharmaceutical Associates, Inc. THEOPHYLLINE 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0121-0825_648d0424-72c7-634f-e053-2a91aa0ad54e 0121-0825 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE SOLUTION ORAL 20161114 ANDA ANDA206573 Pharmaceutical Associates, Inc. MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0121-0978_5a1ef815-2b6b-52d5-e053-2991aa0a85cb 0121-0978 HUMAN PRESCRIPTION DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 19820210 ANDA ANDA087513 Pharmaceutical Associates, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/10mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0121-1008_602b1755-9704-7781-e053-2a91aa0ad854 0121-1008 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEINE PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA087508 Pharmaceutical Associates, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/12.5mL; mg/12.5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 0121-1154_5436a0ac-dd6c-4a34-e054-00144ff88e88 0121-1154 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 19660730 ANDA ANDA074623 Pharmaceutical Associates, Inc, LACTULOSE 20 g/30mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 0121-1190_4bd10bd0-f555-11cd-e054-00144ff88e88 0121-1190 HUMAN PRESCRIPTION DRUG Sodium Citrate and Citric Acid SODIUM CITRATE and CITRIC ACID MONOHYDRATE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Pharmaceutical Associates, Inc. SODIUM CITRATE; ANHYDROUS CITRIC ACID 500; 334 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0121-1276_4b481e49-7547-3345-e054-00144ff8d46c 0121-1276 HUMAN OTC DRUG GUAIFENESIN DM GUAIFENESIN and DEXTROMETHORPHAN SYRUP ORAL 19920701 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN; DEXTROMETHORPHAN 100; 10 mg/5mL; mg/5mL N 20181231 0121-1314_4b472494-2979-53fd-e054-00144ff88e88 0121-1314 HUMAN OTC DRUG Acetaminophen Acetaminophen SOLUTION ORAL 20070801 OTC MONOGRAPH NOT FINAL part343 Pharmaceutical Associates, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 0121-1350_5f37fcae-3eee-29b5-e053-2a91aa0a70c2 0121-1350 HUMAN PRESCRIPTION DRUG VALPROIC ACID VALPROIC ACID SOLUTION ORAL 20050411 ANDA ANDA075379 Pharmaceutical Associates, Inc. VALPROIC ACID 500 mg/10mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0121-1488_63f0e37d-e6e4-dec5-e053-2991aa0a2244 0121-1488 HUMAN OTC DRUG GUAIFENESIN GUAIFENESIN SOLUTION ORAL 20020901 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN 200 mg/10mL N 20191231 0121-1542_2872e73b-2895-4319-8c65-2ec29c17d0ad 0121-1542 HUMAN PRESCRIPTION DRUG Zamicet HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20080818 ANDA ANDA040834 Pharmaceutical Associates, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 163 mg/7.5mL; mg/7.5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0121-1544_4b47f3d3-a59b-5a4e-e054-00144ff8d46c 0121-1544 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20130729 ANDA ANDA040838 Pharmaceutical Associates, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0121-1548_61fabc0c-4e17-793e-e053-2a91aa0a4f4b 0121-1548 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN SUSPENSION ORAL 20040923 ANDA ANDA076925 Pharmaceutical Associates, Inc. IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 0121-1550_60a55dbd-cba5-3f21-e053-2991aa0a66c7 0121-1550 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN; CODEINE PHOSPHATE 100; 10 mg/5mL; mg/5mL CV N 20181231 0121-1576_602b2124-a88a-0bd0-e053-2a91aa0a7acc 0121-1576 HUMAN PRESCRIPTION DRUG Metoclopramide metoclopramide hydrochloride SOLUTION ORAL 19910601 ANDA ANDA072744 Pharmaceutical Associates, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0121-1598_5f390f7d-cdd5-d745-e053-2991aa0a46da 0121-1598 HUMAN PRESCRIPTION DRUG Levetiracetam LEVETIRACETAM SOLUTION ORAL 20150604 ANDA ANDA201157 Pharmaceutical Associates, Inc. LEVETIRACETAM 1000 mg/10mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0121-1744_63f0e37d-e6e4-dec5-e053-2991aa0a2244 0121-1744 HUMAN OTC DRUG GUAIFENESIN GUAIFENESIN SOLUTION ORAL 20020901 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN 100 mg/5mL N 20191231 0121-1760_590dd219-4a17-43d7-88d6-2bac02ba562c 0121-1760 HUMAN OTC DRUG Mag-AL Liquid Aluminum Hydroxide and Magnesium Hydroxide SUSPENSION ORAL 20040114 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 200; 200 mg/5mL; mg/5mL N 20181231 0121-1761_8b4e59b7-d1f2-4e98-a610-c24071c543f9 0121-1761 HUMAN OTC DRUG Mag-AL Plus Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone SUSPENSION ORAL 20040114 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 0121-1762_11928a48-9b30-4547-baaa-76e89599611c 0121-1762 HUMAN OTC DRUG Mag-AL Plus XS Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone SUSPENSION ORAL 20040114 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 0121-1775_60a55dbd-cba5-3f21-e053-2991aa0a66c7 0121-1775 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN; CODEINE PHOSPHATE 100; 10 mg/5mL; mg/5mL CV N 20181231 0121-1781_4b481e49-75b0-3345-e054-00144ff8d46c 0121-1781 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20070917 OTC MONOGRAPH NOT FINAL part343 Pharmaceutical Associates, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 0121-1781_5f446430-b4e0-4bfb-bc2e-d00b50c273cb 0121-1781 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20141001 OTC MONOGRAPH NOT FINAL part343 Pharmaceutical Associates, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 0121-1836_648ca080-bdbd-7f71-e053-2991aa0acbe2 0121-1836 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20141201 ANDA ANDA074937 Pharmaceutical Associates, Inc. IBUPROFEN 100 mg/5mL N 20191231 0121-1971_4b472494-2979-53fd-e054-00144ff88e88 0121-1971 HUMAN OTC DRUG Acetaminophen Acetaminophen SOLUTION ORAL 20070801 OTC MONOGRAPH NOT FINAL part343 Pharmaceutical Associates, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 0121-2232_63f0e37d-e6e4-dec5-e053-2991aa0a2244 0121-2232 HUMAN OTC DRUG GUAIFENESIN GUAIFENESIN SOLUTION ORAL 20020901 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN 300 mg/15mL N 20191231 0121-2313_2872e73b-2895-4319-8c65-2ec29c17d0ad 0121-2313 HUMAN PRESCRIPTION DRUG Zamicet HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20080818 ANDA ANDA040834 Pharmaceutical Associates, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0121-2316_4b47f3d3-a59b-5a4e-e054-00144ff8d46c 0121-2316 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20130729 ANDA ANDA040838 Pharmaceutical Associates, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0121-2397_5f390f7d-cdd5-d745-e053-2991aa0a46da 0121-2397 HUMAN PRESCRIPTION DRUG Levetiracetam LEVETIRACETAM SOLUTION ORAL 20150604 ANDA ANDA201157 Pharmaceutical Associates, Inc. LEVETIRACETAM 1500 mg/15mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0121-4577_5436a0ac-dd6c-4a34-e054-00144ff88e88 0121-4577 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 19660730 ANDA ANDA074623 Pharmaceutical Associates, Inc, LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 0121-4675_5f37fcae-3eee-29b5-e053-2a91aa0a70c2 0121-4675 HUMAN PRESCRIPTION DRUG VALPROIC ACID VALPROIC ACID SOLUTION ORAL 20050411 ANDA ANDA075379 Pharmaceutical Associates, Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0121-4721_517b83d8-454f-166c-e054-00144ff88e88 0121-4721 HUMAN PRESCRIPTION DRUG Fluoxetine FLUOXETINE HYDROCHLORIDE SOLUTION ORAL 20020201 ANDA ANDA076015 Pharmaceutical Associates, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0121-4727_506a5144-f5ca-4eab-9cc9-e5dfa2a38b4e 0121-4727 HUMAN PRESCRIPTION DRUG Ranitidine RANITIDINE SYRUP ORAL 20101101 ANDA ANDA077405 Pharmaceutical Associates, Inc. RANITIDINE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0121-4766_c2bfaeaa-1ed1-46e5-84b2-3a20c46eb9f4 0121-4766 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate SUSPENSION ORAL 20041201 OTC MONOGRAPH FINAL part331 Pharmaceutical Associates, Inc. CALCIUM CARBONATE 1250 mg/5mL N 20181231 0121-4772_4b47f3d3-a59b-5a4e-e054-00144ff8d46c 0121-4772 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20130729 ANDA ANDA040838 Pharmaceutical Associates, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0121-4774_61fabc0c-4e17-793e-e053-2a91aa0a4f4b 0121-4774 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN SUSPENSION ORAL 20040923 ANDA ANDA076925 Pharmaceutical Associates, Inc. IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 0121-4776_4e2f674a-898e-668f-e054-00144ff88e88 0121-4776 HUMAN PRESCRIPTION DRUG Megestrol Acetate MEGESTROL ACETATE SUSPENSION ORAL 20060707 ANDA ANDA076721 Pharmaceutical Associates, Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0121-4780_4a1a8f26-6fea-49cd-85cc-9e7ea7e7eee8 0121-4780 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SYRUP ORAL 20090915 ANDA ANDA090300 Pharmaceutical Associates, Inc. CETIRIZINE HYDROCHLORIDE 5 mg/5mL E 20171231 0121-4785_7f6f191e-0969-4d20-8189-e65fb74bad39 0121-4785 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20090601 ANDA ANDA062512 Pharmaceutical Associates, Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0121-4788_fc72c9e4-1bc6-4d5c-b4e9-ca85e11dc8ba 0121-4788 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE CYPROHEPTADINE SYRUP ORAL 20130729 ANDA ANDA091295 Pharmaceutical Associates, Inc. CYPROHEPTADINE 2 mg/5mL E 20171231 0121-4793_024deb75-5165-4051-960d-e3376f4c8a92 0121-4793 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20080702 ANDA ANDA077612 Pharmaceutical Associates, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 0121-4794_d0cc7207-c3ca-4f0b-99b6-82409a0a0255 0121-4794 HUMAN PRESCRIPTION DRUG Theophylline THEOPHYLLINE ANHYDROUS SOLUTION ORAL 20081103 ANDA ANDA085186 Pharmaceutical Associates, Inc. THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0121-4799_5f390f7d-cdd5-d745-e053-2991aa0a46da 0121-4799 HUMAN PRESCRIPTION DRUG Levetiracetam LEVETIRACETAM SOLUTION ORAL 20150604 ANDA ANDA201157 Pharmaceutical Associates, Inc. LEVETIRACETAM 500 mg/5mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0121-4802_6896783a-f114-4488-8538-2cd46eb21460 0121-4802 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM SOLUTION ORAL 20090211 ANDA ANDA090028 Pharmaceutical Associates, Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 0121-4803_e58126c2-3e53-46eb-8c75-367d45aa84bd 0121-4803 HUMAN OTC DRUG Pink Bismuth Bismuth Subsalicylate SUSPENSION ORAL 20090920 OTC MONOGRAPH FINAL part335 Pharmaceutical Associates, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL E 20171231 0121-4809_58f894c7-263c-433a-af8d-7073c7079917 0121-4809 HUMAN OTC DRUG Guaifenesin DM GUAIFENESIN and DEXTROMETHORPHAN SOLUTION ORAL 20100517 OTC MONOGRAPH FINAL part341 Pharmaceutical Associates, Inc. GUAIFENESIN; DEXTROMETHORPHAN 200; 10 mg/5mL; mg/5mL E 20171231 0121-4810_4b481e49-755d-3345-e054-00144ff8d46c 0121-4810 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20160201 ANDA ANDA203621 Pharmaceutical Associates, Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0121-4811_e3654484-17cf-4a69-8bc3-34a6b4dab821 0121-4811 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP ORAL 20091228 ANDA ANDA088008 Pharmaceutical Associates, Inc. HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0121-4820_504d4800-cb3f-1148-e054-00144ff88e88 0121-4820 HUMAN PRESCRIPTION DRUG THEOPHYLLINE THEOPHYLLINE SOLUTION ORAL 20161216 ANDA ANDA206344 Pharmaceutical Associates, Inc. THEOPHYLLINE 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0121-4822_f86276e9-0aff-4be7-895d-437a11fd12ac 0121-4822 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride SYRUP ORAL 20150101 ANDA ANDA087294 Pharmaceutical Associates, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0121-4839_86340210-3a0c-4df4-bc70-fea97359d840 0121-4839 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20160516 ANDA ANDA206456 Pharmaceutical Associates, Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0126-0016_2ea205cb-f718-4994-bacd-cb4d168e5c53 0126-0016 HUMAN PRESCRIPTION DRUG PreviDent 5000 Dry Mouth Sodium fluoride GEL, DENTIFRICE DENTAL 20090706 UNAPPROVED DRUG OTHER Colgate-Palmolive Company SODIUM FLUORIDE 13.5 mg/mL N 20181231 0126-0021_48d783af-cd13-454c-b061-ea713b967024 0126-0021 HUMAN OTC DRUG Colgate Dry Mouth Relief SODIUM FLUORIDE RINSE DENTAL 20110114 OTC MONOGRAPH FINAL part355 Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 2.1 mg/10mL E 20171231 0126-0022_199b6e21-1f63-4942-85cd-505ed02a5c50 0126-0022 HUMAN PRESCRIPTION DRUG PreviDent 5000 Enamel Protect SODIUM FLUORIDE and POTASSIUM NITRATE GEL, DENTIFRICE DENTAL 20110330 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE; POTASSIUM NITRATE 6; 57.5 mg/mL; mg/mL N 20181231 0126-0023_f276116e-cbe3-4827-92f8-59756e15fb81 0126-0023 HUMAN OTC DRUG Colgate Total Freshmint CETYLPYRIDINIUM CHLORIDE MOUTHWASH DENTAL 20100701 OTC MONOGRAPH NOT FINAL part356 Colgate Oral Pharmaceuticals, Inc. CETYLPYRIDINIUM CHLORIDE 10.5 mg/20mL E 20171231 0126-0024_31dd69c6-cc90-4040-8abc-c79c4670e6c2 0126-0024 HUMAN OTC DRUG Colgate Total Peppermint CETYLPYRIDINIUM CHLORIDE MOUTHWASH DENTAL 20100701 OTC MONOGRAPH NOT FINAL part356 Colgate Oral Pharmaceuticals CETYLPYRIDINIUM CHLORIDE 10.5 mg/20mL E 20171231 0126-0025_1902b258-2ef3-4b9f-8957-9ab43d2001f7 0126-0025 HUMAN OTC DRUG Colgate Total Gentle Care Softmint CETYLPYRIDINIUM CHLORIDE MOUTHWASH DENTAL 20100701 OTC MONOGRAPH NOT FINAL part356 Colgate Oral Pharmaceuticals, Inc. CETYLPYRIDINIUM CHLORIDE 10.5 mg/20mL E 20171231 0126-0026_a02bd250-d064-4ccc-9135-c8a3306e79f4 0126-0026 HUMAN OTC DRUG Colgate Total Whitening Sparklemint CETYLPYRIDINIUM CHLORIDE MOUTHWASH DENTAL 20100701 OTC MONOGRAPH NOT FINAL part356 Colgate Oral Pharmaceuticals CETYLPYRIDINIUM CHLORIDE 10.5 mg/20mL E 20171231 0126-0027_b4e77cb8-e8fd-406e-a83d-9cd512cbb403 0126-0027 HUMAN OTC DRUG Colgate Cavity Protection Great Regular Flavor Sodium Monofluorophosphate PASTE DENTAL 20120203 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM MONOFLUOROPHOSPHATE 11.4 mg/g E 20171231 0126-0032_3cc727a0-ad54-4111-b014-9e33e911a860 0126-0032 HUMAN OTC DRUG Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride SODIUM FLUORIDE RINSE DENTAL 20110112 OTC MONOGRAPH FINAL part355 Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 2 mg/10mL N 20181231 0126-0033_a95afa05-e4bb-4f4d-ab21-7b1a61c60a20 0126-0033 HUMAN PRESCRIPTION DRUG PreviDent Alcohol Free Sodium Fluoride MOUTHWASH DENTAL 20160613 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 2 mg/mL N 20181231 0126-0034_763e4cd0-bb4b-4fc3-8919-6071d9e7a67c 0126-0034 HUMAN OTC DRUG Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride SODIUM FLUORIDE RINSE DENTAL 20160527 OTC MONOGRAPH FINAL part355 Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 2 mg/10mL E 20171231 0126-0065_367cc743-6f10-4a10-b57d-0fcdc44793dc 0126-0065 HUMAN OTC DRUG Colgate Orabase Benzocaine PASTE, DENTIFRICE TOPICAL 20100831 OTC MONOGRAPH NOT FINAL part356 Colgate Oral Pharmaceuticals, Inc. BENZOCAINE 200 mg/g E 20171231 0126-0070_e4aefcbf-56d5-457e-8dbc-7704f5b3ed36 0126-0070 HUMAN PRESCRIPTION DRUG PreviDent 5000 Sensitive Sodium fluoride GEL, DENTIFRICE DENTAL 20090706 UNAPPROVED DRUG OTHER Colgate-Palmolive Company SODIUM FLUORIDE; POTASSIUM NITRATE 12.7; 57.5 mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 0126-0072_35a52b51-c6c2-415c-8013-2306cdf986c5 0126-0072 HUMAN PRESCRIPTION DRUG PreviDent 5000 Booster Plus Fruitastic Sodium Fluoride PASTE, DENTIFRICE DENTAL 20150301 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 6 mg/mL N 20181231 0126-0074_ddbb5257-3df8-48a8-9a16-1d21c56526fa 0126-0074 HUMAN PRESCRIPTION DRUG PrevidDent 5000 Booster Plus Spearmint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20150301 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 6 mg/mL E 20171231 0126-0075_33c288df-0d48-404b-b280-88ff8ea4a7fa 0126-0075 HUMAN PRESCRIPTION DRUG PreviDent 5000 Booster Sodium fluoride GEL, DENTIFRICE DENTAL 20090706 UNAPPROVED DRUG OTHER Colgate-Palmolive Company SODIUM FLUORIDE 13.4 mg/mL E 20171231 0126-0076_92e94b16-8990-4ece-b676-ba5edf0d15c8 0126-0076 HUMAN PRESCRIPTION DRUG PreviDent 5000 Booster Sodium fluoride GEL, DENTIFRICE DENTAL 20090706 UNAPPROVED DRUG OTHER Colgate-Palmolive Company SODIUM FLUORIDE 13.4 mg/mL E 20171231 0126-0082_a983588f-a259-44e8-b3f0-248d58b05ef3 0126-0082 HUMAN OTC DRUG Orabase Benzocaine Purple Ice Benzocaine PASTE, DENTIFRICE DENTAL 20120801 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. BENZOCAINE 19.8 mg/g E 20171231 0126-0083_258b7bc0-2283-4e0c-a414-2e64f5ffcccc 0126-0083 HUMAN OTC DRUG Peroxyl Mouth Sore Mild Mint Hydrogen Peroxide RINSE BUCCAL 20090101 OTC MONOGRAPH NOT FINAL part356 Colgate Oral Pharmaceuticals, Inc. HYDROGEN PEROXIDE 15 mg/mL N 20181231 0126-0088_3ba50dc1-3bef-473c-bcde-a0574bb367a1 0126-0088 HUMAN PRESCRIPTION DRUG PreviDent Fresh Mint Sodium Fluoride GEL, DENTIFRICE DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 5 mg/g N 20181231 0126-0131_72640a14-d84e-4b3f-ac27-99ccdbb5cdc0 0126-0131 HUMAN PRESCRIPTION DRUG Phos-Flur Sodium Fluoride GEL, DENTIFRICE DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 11 mg/g E 20171231 0126-0135_3da7c2c8-f2d2-4605-b90d-9ba623d95048 0126-0135 HUMAN OTC DRUG Phos-Flur Ortho Defense SODIUM FLUORIDE RINSE DENTAL 20110112 OTC MONOGRAPH FINAL part355 Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 2 mg/10mL E 20171231 0126-0138_3f1b7afb-e178-4f2f-bdf0-2a312bb3c33d 0126-0138 HUMAN OTC DRUG Phos-Flur Ortho Defense SODIUM FLUORIDE RINSE DENTAL 20110215 OTC MONOGRAPH FINAL part355 Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 2 mg/10mL E 20171231 0126-0139_bc93d2a8-3a13-4f6d-b915-0e23d5abfcfe 0126-0139 HUMAN OTC DRUG Phos-Flur Ortho Defense SODIUM FLUORIDE RINSE DENTAL 20110211 OTC MONOGRAPH FINAL part355 Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 4.42 mg/10mL E 20171231 0126-0165_2f374c51-e1c1-4d7a-be17-d53611253506 0126-0165 HUMAN OTC DRUG Gel-Kam Fruit and Berry Stannous Fluoride GEL, DENTIFRICE DENTAL 19900101 OTC MONOGRAPH FINAL part355 Colgate Oral Pharmaceuticals, Inc. STANNOUS FLUORIDE 4 mg/g N 20181231 0126-0179_3e8f2dee-5e1c-4666-a5ac-36b1730055d2 0126-0179 HUMAN PRESCRIPTION DRUG PreviDent Sodium Fluoride MOUTHWASH DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 2 mg/mL E 20171231 0126-0192_2f374c51-e1c1-4d7a-be17-d53611253506 0126-0192 HUMAN OTC DRUG Gel-Kam Mint Stannous Fluoride GEL, DENTIFRICE DENTAL 19900101 OTC MONOGRAPH FINAL part355 Colgate Oral Pharmaceuticals, Inc. STANNOUS FLUORIDE 4 mg/g N 20181231 0126-0271_60b307a6-cb51-46eb-b4a5-66927750fa5a 0126-0271 HUMAN PRESCRIPTION DRUG Periogard Chlorhexidine Gluconate RINSE BUCCAL 19980101 ANDA ANDA073695 Colgate Oral Pharmaceuticals, Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] E 20171231 0126-0272_f2e02c1b-3e0d-4e18-80df-7cf0b67ed1c2 0126-0272 HUMAN PRESCRIPTION DRUG PerioGard Alcohol Free Chlorhexidine Gluconate RINSE BUCCAL 20160129 ANDA ANDA203212 Colgate Oral Pharmaceuticals, Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] E 20171231 0126-0286_bbe25b36-c11e-4809-9367-b695a89affa5 0126-0286 HUMAN PRESCRIPTION DRUG PreviDent 5000 Plus Fruitastic Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 11 mg/mL E 20171231 0126-0287_56ef544c-b840-4290-9618-c5161fac80a5 0126-0287 HUMAN PRESCRIPTION DRUG PreviDent 5000 Plus Spearmint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 11 mg/mL E 20171231 0126-0287_bbe25b36-c11e-4809-9367-b695a89affa5 0126-0287 HUMAN PRESCRIPTION DRUG PreviDent 5000 Plus Spearmint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 11 mg/mL E 20171231 0126-0288_3ba50dc1-3bef-473c-bcde-a0574bb367a1 0126-0288 HUMAN PRESCRIPTION DRUG PreviDent Very Berry Sodium Fluoride GEL, DENTIFRICE DENTAL 20120829 UNAPPROVED DRUG OTHER Colgate Oral Pharmaceuticals, Inc. SODIUM FLUORIDE 5 mg/g N 20181231 0131-1810_5e2fac91-ec8b-069e-e053-2a91aa0a8546 0131-1810 HUMAN PRESCRIPTION DRUG Vimpat lacosamide INJECTION INTRAVENOUS 20090526 NDA NDA022254 UCB, Inc. LACOSAMIDE 10 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 0131-2470_5e2fac91-ec8b-069e-e053-2a91aa0a8546 0131-2470 HUMAN PRESCRIPTION DRUG Vimpat lacosamide KIT 20090526 NDA NDA022253 UCB, Inc. N 20181231 0131-2477_5e2fac91-ec8b-069e-e053-2a91aa0a8546 0131-2477 HUMAN PRESCRIPTION DRUG Vimpat lacosamide TABLET, FILM COATED ORAL 20090526 NDA NDA022253 UCB, Inc. LACOSAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 0131-2478_5e2fac91-ec8b-069e-e053-2a91aa0a8546 0131-2478 HUMAN PRESCRIPTION DRUG Vimpat lacosamide TABLET, FILM COATED ORAL 20090526 NDA NDA022253 UCB, Inc. LACOSAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 0131-2479_5e2fac91-ec8b-069e-e053-2a91aa0a8546 0131-2479 HUMAN PRESCRIPTION DRUG Vimpat lacosamide TABLET, FILM COATED ORAL 20090526 NDA NDA022253 UCB, Inc. LACOSAMIDE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 0131-2480_5e2fac91-ec8b-069e-e053-2a91aa0a8546 0131-2480 HUMAN PRESCRIPTION DRUG Vimpat lacosamide TABLET, FILM COATED ORAL 20090526 NDA NDA022253 UCB, Inc. LACOSAMIDE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 0131-3267_bab8117c-8120-431c-9b4d-befb0f303d73 0131-3267 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 20180331 NDA NDA022104 UCB, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0131-3268_bab8117c-8120-431c-9b4d-befb0f303d73 0131-3268 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 20180331 NDA NDA022104 UCB, Inc. VENLAFAXINE HYDROCHLORIDE 225 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0131-5410_5e2fac91-ec8b-069e-e053-2a91aa0a8546 0131-5410 HUMAN PRESCRIPTION DRUG Vimpat lacosamide SOLUTION ORAL 20100420 NDA NDA022255 UCB, Inc. LACOSAMIDE 10 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 0132-0079_3bf664a6-1b3a-4285-af88-1cd9ac6e3f13 0132-0079 HUMAN OTC DRUG Fleet Glycerin SUPPOSITORY RECTAL 19841101 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 2 g/1 N 20181231 0132-0079_615a03f3-1dc4-45e4-a2ac-1e4f60826e4c 0132-0079 HUMAN OTC DRUG Fleet Glycerin SUPPOSITORY RECTAL 19841101 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 2 g/1 N 20181231 0132-0079_9ea0e0c0-22c7-455e-bcee-0c7885671673 0132-0079 HUMAN OTC DRUG Fleet Glycerin SUPPOSITORY RECTAL 19841101 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 2 g/1 N 20181231 0132-0079_db941405-3d42-452f-83b2-d45d9cb86b3d 0132-0079 HUMAN OTC DRUG Fleet Glycerin SUPPOSITORY RECTAL 19841101 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 2 g/1 N 20181231 0132-0081_09635746-e54a-4abf-a444-894163f34f76 0132-0081 HUMAN OTC DRUG Pedia-Lax Glycerin SUPPOSITORY RECTAL 20080301 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 1 g/1 N 20181231 0132-0106_e8816dce-8c24-4e27-9a41-b64eecb0497a 0132-0106 HUMAN OTC DRUG Pedia-Lax Docusate Sodium LIQUID ORAL 20080301 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. DOCUSATE SODIUM 50 mg/15mL N 20181231 0132-0119_5d796181-8d4f-4fb3-b0d2-89352cd9e282 0132-0119 HUMAN OTC DRUG Fleet Enema ENEMA RECTAL 20110526 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. SODIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC 19; 7 g/133mL; g/133mL N 20181231 0132-0185_b8383194-2a18-406a-a499-8696d218b37a 0132-0185 HUMAN OTC DRUG Fleet Glycerin LIQUID RECTAL 20020603 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 5.4 g/1 N 20181231 0132-0190_3f2cb644-2271-42c1-a64b-6351c07e698e 0132-0190 HUMAN OTC DRUG Pedia-Lax Glycerin LIQUID RECTAL 20080301 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. GLYCERIN 2.8 g/1 N 20181231 0132-0194_15079401-c9d2-49d2-86e4-7cb9b7e5c07d 0132-0194 HUMAN OTC DRUG Boudreauxs Zinc Oxide PASTE TOPICAL 20161001 OTC MONOGRAPH FINAL part347 C.B. Fleet Company, Inc. ZINC OXIDE 40 g/100g N 20181231 0132-0201_00c5b580-1fe5-49f0-bbca-25506c75cf6f 0132-0201 HUMAN OTC DRUG Fleet sodium phosphate, dibasic and sodium phosphate, monobasic ENEMA RECTAL 19530310 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/133mL; g/133mL N 20181231 0132-0201_b574e93a-5c0b-4eaa-b8ce-2e5ffc539afe 0132-0201 HUMAN OTC DRUG Fleet sodium phosphate, dibasic and sodium phosphate, monobasic ENEMA RECTAL 20040625 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/230mL; g/230mL N 20181231 0132-0202_d209543b-7e07-4f13-8972-24ecd6059321 0132-0202 HUMAN OTC DRUG Pedia-Lax sodium phosphate, dibasic and sodium phosphate, monobasic ENEMA RECTAL 20020510 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC 3.5; 9.5 g/66mL; g/66mL N 20181231 0132-0208_f0bef930-aed3-4ecf-9b2c-451fba7fd69b 0132-0208 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20120201 OTC MONOGRAPH FINAL part332 C.B. Fleet Company, Inc. DIMETHICONE 180 mg/1 N 20181231 0132-0211_058bdc7c-defc-4c1e-aebc-c14e57ac80e6 0132-0211 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20140401 OTC MONOGRAPH FINAL part332 C.B. Fleet Company, Inc. DIMETHICONE 250 mg/1 N 20181231 0132-0214_092e34ee-561f-4ffa-bef7-4cad045b3f33 0132-0214 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20140401 OTC MONOGRAPH FINAL part332 C.B. Fleet Company, Inc. DIMETHICONE 250 mg/1 N 20181231 0132-0215_f7bd29f0-09fe-4cb3-af7d-bc35c5737bba 0132-0215 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20140401 OTC MONOGRAPH FINAL part332 C.B. Fleet Company, Inc. DIMETHICONE 250 mg/1 N 20181231 0132-0301_e911893f-de79-404d-aae1-c67c4a71b90f 0132-0301 HUMAN OTC DRUG Fleet Mineral Oil ENEMA RECTAL 20020501 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. MINERAL OIL 118 mL/118mL N 20181231 0132-0323_e5d7f3e4-cdb9-405b-a1ef-be35b42686ba 0132-0323 HUMAN OTC DRUG Boudreauxs Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 C.B. Fleet Company, Inc. ZINC OXIDE 40 g/113g N 20181231 0132-0333_343d2ab8-551d-482a-a4f7-0f70b5a1f8ee 0132-0333 HUMAN OTC DRUG Boudreauxs Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 C.B. Fleet Company, Inc. ZINC OXIDE 16 g/113g N 20181231 0132-0334_1855f24f-5645-4a73-868c-ae1098c1b99d 0132-0334 HUMAN OTC DRUG Boudreauxs Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 C.B. Fleet Company, Inc. ZINC OXIDE 16 g/113g N 20181231 0132-0507_428c1326-85da-4bc5-a2ae-1f7e10e31ef0 0132-0507 HUMAN OTC DRUG PHAZYME Simethicone and Calcium Carbonate TABLET, CHEWABLE ORAL 20160301 OTC MONOGRAPH FINAL part332 C.B. Fleet Company, Inc. CALCIUM CARBONATE; DIMETHICONE 750; 250 mg/241; mg/241 N 20181231 0132-0522_08d5e166-5618-435a-9e6f-b81a0ae5ac2a 0132-0522 HUMAN OTC DRUG Fleet Glycerin and Phenylephrine HCI and Pramoxine HCI CLOTH TOPICAL 20160301 20180731 OTC MONOGRAPH FINAL part346 C.B. Fleet Company, Inc. GLYCERIN; PRAMOXINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 20; 1; .25 g/241; g/241; g/241 N 20181231 0132-0655_1d2d5fce-72b8-47b9-bb92-486891bbfbb7 0132-0655 HUMAN OTC DRUG Pedia-Lax Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080301 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. MAGNESIUM HYDROXIDE 400 mg/1 E 20171231 0132-0703_36be417e-8635-49a0-930e-12d1d4b86dcf 0132-0703 HUMAN OTC DRUG Fleet Bisacodyl ENEMA RECTAL 20020510 OTC MONOGRAPH NOT FINAL part334 C.B. Fleet Company, Inc. BISACODYL 10 mg/30mL N 20181231 0132-8743_07c648cb-ba5e-402a-91a1-271c43d1ae36 0132-8743 HUMAN OTC DRUG Summers Eve POVIDONE-IODINE DOUCHE VAGINAL 20020510 OTC MONOGRAPH NOT FINAL part330 C.B. Fleet Company, Inc. POVIDONE-IODINE 4 g/133mL N 20181231 0135-0070_e0ad0a32-4631-49f6-a90a-0ce707c91ac5 0135-0070 HUMAN OTC DRUG TUMS calcium carbonate TABLET ORAL 20100310 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 500 mg/1 N 20181231 0135-0071_e0ad0a32-4631-49f6-a90a-0ce707c91ac5 0135-0071 HUMAN OTC DRUG TUMS calcium carbonate TABLET ORAL 20100310 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 500 mg/1 N 20181231 0135-0074_032b6967-e3bb-4d2b-adca-ba78c2f4e98a 0135-0074 HUMAN OTC DRUG TUMS EX calcium carbonate TABLET ORAL 20100118 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0076_032b6967-e3bb-4d2b-adca-ba78c2f4e98a 0135-0076 HUMAN OTC DRUG TUMS EX calcium carbonate TABLET ORAL 20100118 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0089_c37eb107-00f0-4d27-9ef6-eb12c199508a 0135-0089 HUMAN OTC DRUG CITRUCEL methylcellulose POWDER, FOR SOLUTION ORAL 20100916 OTC MONOGRAPH NOT FINAL part334 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC METHYLCELLULOSE (4000 MPA.S) 2 g/19g N 20181231 0135-0090_c37eb107-00f0-4d27-9ef6-eb12c199508a 0135-0090 HUMAN OTC DRUG CITRUCEL methylcellulose POWDER, FOR SOLUTION ORAL 20100916 OTC MONOGRAPH NOT FINAL part334 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC METHYLCELLULOSE (4000 MPA.S) 2 g/10.2g N 20181231 0135-0094_cc005e91-b5ea-4509-8abc-e64f9805d756 0135-0094 HUMAN OTC DRUG GAVISCON aluminum hydroxide and magnesium carbonate LIQUID ORAL 20110114 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 95; 358 mg/15mL; mg/15mL N 20181231 0135-0095_cc005e91-b5ea-4509-8abc-e64f9805d756 0135-0095 HUMAN OTC DRUG GAVISCON aluminum hydroxide and magnesium carbonate LIQUID ORAL 20110114 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 254; 237.5 mg/5mL; mg/5mL N 20181231 0135-0096_a6624502-a0b5-464c-a149-f29189b41276 0135-0096 HUMAN OTC DRUG Gaviscon Regular Strength aluminum hydroxide and magnesium trisilicate TABLET, CHEWABLE ORAL 20110613 NDA NDA018685 GlaxoSmithKline Consumer Healthcare LP ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE 80; 14.2 mg/1; mg/1 N 20181231 0135-0098_a6624502-a0b5-464c-a149-f29189b41276 0135-0098 HUMAN OTC DRUG Gaviscon Extra Strength aluminum hydroxide and magnesium carbonate TABLET, CHEWABLE ORAL 20110613 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare LP ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 N 20181231 0135-0118_4868a9a5-9b6d-4613-8cb8-03b497cfceea 0135-0118 HUMAN OTC DRUG TUMS ULTRA calcium carbonate TABLET, CHEWABLE ORAL 20100212 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 0135-0126_d1c6d524-9d29-46e9-be67-f36d3b6055c7 0135-0126 HUMAN OTC DRUG Aquafresh sodium monofluorophosphate PASTE DENTAL 20110128 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM MONOFLUOROPHOSPHATE 1.1 mg/g N 20181231 0135-0129_07bfb6ab-064f-4ace-87eb-7981f2d99aeb 0135-0129 HUMAN OTC DRUG Aquafresh Cavity Protection sodium monofluorophosphate PASTE DENTAL 20110128 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g N 20181231 0135-0130_07bfb6ab-064f-4ace-87eb-7981f2d99aeb 0135-0130 HUMAN OTC DRUG Aquafresh Cavity Protection sodium monofluorophosphate PASTE DENTAL 20110128 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g N 20181231 0135-0132_83e40989-0833-488b-8b21-8471e519cd2d 0135-0132 HUMAN OTC DRUG AQUAFRESH SENSITIVE MAXIMUM STRENGTH potassium nitrate and sodium fluoride PASTE DENTAL 20110329 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0135_45fc4a8a-26e0-44a5-8033-50dfc8978a13 0135-0135 HUMAN OTC DRUG PANADOL Extra Strength acetaminophen TABLET ORAL 20110318 20181130 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN 500 mg/1 E 20171231 0135-0136_45fc4a8a-26e0-44a5-8033-50dfc8978a13 0135-0136 HUMAN OTC DRUG PANADOL Extra Strength acetaminophen TABLET, FILM COATED ORAL 20110318 20190531 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN 500 mg/1 E 20171231 0135-0140_032b6967-e3bb-4d2b-adca-ba78c2f4e98a 0135-0140 HUMAN OTC DRUG TUMS EX calcium carbonate TABLET ORAL 20100118 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0145_f591d154-61e5-460f-8ecc-3523da838720 0135-0145 HUMAN OTC DRUG NICODERM CQ nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20110512 NDA NDA020165 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 21 mg/24h N 20181231 0135-0154_032b6967-e3bb-4d2b-adca-ba78c2f4e98a 0135-0154 HUMAN OTC DRUG TUMS EX calcium carbonate TABLET ORAL 20100118 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0157_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0157 HUMAN OTC DRUG Nicorette Original nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA018612 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 2 mg/1 N 20181231 0135-0158_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0158 HUMAN OTC DRUG Nicorette Original nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA020066 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 4 mg/1 N 20181231 0135-0178_032b6967-e3bb-4d2b-adca-ba78c2f4e98a 0135-0178 HUMAN OTC DRUG TUMS EX calcium carbonate TABLET ORAL 20100118 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0180_4868a9a5-9b6d-4613-8cb8-03b497cfceea 0135-0180 HUMAN OTC DRUG TUMS ULTRA calcium carbonate TABLET, CHEWABLE ORAL 20100212 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 0135-0181_4868a9a5-9b6d-4613-8cb8-03b497cfceea 0135-0181 HUMAN OTC DRUG TUMS ULTRA calcium carbonate TABLET, CHEWABLE ORAL 20100212 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 0135-0194_f591d154-61e5-460f-8ecc-3523da838720 0135-0194 HUMAN OTC DRUG NICODERM CQ nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20110512 NDA NDA020165 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 21 mg/24h N 20181231 0135-0195_f591d154-61e5-460f-8ecc-3523da838720 0135-0195 HUMAN OTC DRUG NICODERM CQ nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20110512 NDA NDA020165 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 14 mg/24h N 20181231 0135-0196_f591d154-61e5-460f-8ecc-3523da838720 0135-0196 HUMAN OTC DRUG NICODERM CQ nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20110512 NDA NDA020165 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 7 mg/24h N 20181231 0135-0199_77729640-b4b2-4664-acb3-0b8928a62483 0135-0199 HUMAN OTC DRUG CITRUCEL methylcellulose TABLET ORAL 20100201 OTC MONOGRAPH NOT FINAL part334 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC METHYLCELLULOSE (4000 MPA.S) 500 mg/1 N 20181231 0135-0200_9dc75a87-9221-4109-a50e-80edb8938022 0135-0200 HUMAN OTC DRUG ABREVA docosanol CREAM TOPICAL 20100319 NDA NDA020941 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC DOCOSANOL 100 mg/g N 20181231 0135-0201_eadd6839-a269-4edd-9006-2382b2eef9bb 0135-0201 HUMAN OTC DRUG AQUAFRESH ULTIMATE WHITE sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.1 mg/g N 20181231 0135-0225_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0225 HUMAN OTC DRUG Nicorette Fresh Mint nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA018612 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 2 mg/1 N 20181231 0135-0226_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0226 HUMAN OTC DRUG Nicorette Fresh Mint nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA020066 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 4 mg/1 N 20181231 0135-0228_4868a9a5-9b6d-4613-8cb8-03b497cfceea 0135-0228 HUMAN OTC DRUG TUMS ULTRA calcium carbonate TABLET, CHEWABLE ORAL 20100212 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 0135-0229_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0229 HUMAN OTC DRUG Nicorette Mint nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA018612 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 2 mg/1 N 20181231 0135-0230_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0230 HUMAN OTC DRUG Nicorette Mint nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA020066 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 4 mg/1 N 20181231 0135-0234_eadd6839-a269-4edd-9006-2382b2eef9bb 0135-0234 HUMAN OTC DRUG AQUAFRESH EXTREME CLEAN WHITENING ACTION sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.13 mg/g N 20181231 0135-0241_6b322d76-d35a-4c50-ae9e-95b3363f9687 0135-0241 HUMAN OTC DRUG Nicorette Fruit Chill nicotine polacrilex GUM, CHEWING ORAL 20090914 NDA NDA018612 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 2 mg/1 N 20181231 0135-0242_6b322d76-d35a-4c50-ae9e-95b3363f9687 0135-0242 HUMAN OTC DRUG Nicorette Fruit Chill nicotine polacrilex GUM, CHEWING ORAL 20090914 NDA NDA020066 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 4 mg/1 N 20181231 0135-0243_766a614a-8b9e-412d-a68b-e5effb800c03 0135-0243 HUMAN OTC DRUG TUMS Smoothies calcium carbonate TABLET, CHEWABLE ORAL 20100324 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0245_766a614a-8b9e-412d-a68b-e5effb800c03 0135-0245 HUMAN OTC DRUG TUMS Smoothies calcium carbonate TABLET, CHEWABLE ORAL 20100324 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0246_766a614a-8b9e-412d-a68b-e5effb800c03 0135-0246 HUMAN OTC DRUG TUMS Smoothies calcium carbonate TABLET, CHEWABLE ORAL 20100324 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0355_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0355 HUMAN OTC DRUG Nicorette Spearmint Burst nicotine polacrilex GUM, CHEWING ORAL 20170913 NDA NDA020066 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 4 mg/1 N 20181231 0135-0430_a6624502-a0b5-464c-a149-f29189b41276 0135-0430 HUMAN OTC DRUG Gaviscon Extra Strength aluminum hydroxide and magnesium carbonate TABLET, CHEWABLE ORAL 20110613 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare LP ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 N 20181231 0135-0432_eadd6839-a269-4edd-9006-2382b2eef9bb 0135-0432 HUMAN OTC DRUG AQUAFRESH EXTREME CLEAN DEEP ACTION sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.13 mg/g N 20181231 0135-0435_eadd6839-a269-4edd-9006-2382b2eef9bb 0135-0435 HUMAN OTC DRUG AQUAFRESH EXTREME CLEAN FRESHENING ACTION sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.13 mg/g N 20181231 0135-0456_766a614a-8b9e-412d-a68b-e5effb800c03 0135-0456 HUMAN OTC DRUG TUMS Smoothies calcium carbonate TABLET, CHEWABLE ORAL 20100324 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0460_b8f344c6-3ae1-4968-b59e-e4fa6cba89e2 0135-0460 HUMAN OTC DRUG SENSODYNE PRONAMEL Daily Protection potassium nitrate and sodium fluoride PASTE ORAL 20101018 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0461_65f531e7-7d98-448e-9c4b-497523b3b8f4 0135-0461 HUMAN OTC DRUG ALLI orlistat CAPSULE ORAL 20070207 NDA NDA021887 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ORLISTAT 60 mg/1 N 20181231 0135-0466_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0466 HUMAN OTC DRUG Nicorette Cinnamon Surge nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA018612 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 2 mg/1 N 20181231 0135-0467_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0467 HUMAN OTC DRUG Nicorette Cinnamon Surge nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA020066 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 4 mg/1 N 20181231 0135-0468_eadd6839-a269-4edd-9006-2382b2eef9bb 0135-0468 HUMAN OTC DRUG AQUAFRESH ADVANCED 2X ENAMEL sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.15 mg/g N 20181231 0135-0469_5648fe18-d15b-42c4-8078-d6efafcc9bdb 0135-0469 HUMAN OTC DRUG TUMS calcium carbonate TABLET, CHEWABLE ORAL 20100407 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0473_eadd6839-a269-4edd-9006-2382b2eef9bb 0135-0473 HUMAN OTC DRUG AQUAFRESH ADVANCED 2X WHITENING sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.1 mg/g N 20181231 0135-0474_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0474 HUMAN OTC DRUG Nicorette White Ice Mint nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA018612 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 2 mg/1 N 20181231 0135-0475_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0475 HUMAN OTC DRUG Nicorette White Ice Mint nicotine polacrilex GUM, CHEWING ORAL 20090629 NDA NDA020066 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 4 mg/1 N 20181231 0135-0484_b8f344c6-3ae1-4968-b59e-e4fa6cba89e2 0135-0484 HUMAN OTC DRUG SENSODYNE PRONAMEL Gentle Whitening potassium nitrate and sodium fluoride PASTE ORAL 20101018 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0487_907b0d6b-e1d2-431e-82cf-9be27f8ac1d7 0135-0487 HUMAN OTC DRUG BIOTENE Fresh Mint Original sodium monofluorophosphate PASTE ORAL 20110418 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 0135-0508_f524f3ab-9af6-4244-91ca-11fb31842f68 0135-0508 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20100301 NDA NDA022360 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 2 mg/1 N 20181231 0135-0509_f524f3ab-9af6-4244-91ca-11fb31842f68 0135-0509 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20100301 NDA NDA022360 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 4 mg/1 N 20181231 0135-0510_272fc359-1d8a-43c5-8eb8-81ab33cc8602 0135-0510 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20101019 NDA NDA021330 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 2 mg/1 N 20181231 0135-0511_272fc359-1d8a-43c5-8eb8-81ab33cc8602 0135-0511 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20101019 NDA NDA021330 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 4 mg/1 N 20181231 0135-0512_272fc359-1d8a-43c5-8eb8-81ab33cc8602 0135-0512 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20101019 NDA NDA021330 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 2 mg/1 N 20181231 0135-0513_272fc359-1d8a-43c5-8eb8-81ab33cc8602 0135-0513 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20101019 NDA NDA021330 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 4 mg/1 N 20181231 0135-0514_272fc359-1d8a-43c5-8eb8-81ab33cc8602 0135-0514 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20101019 NDA NDA021330 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 2 mg/1 N 20181231 0135-0515_272fc359-1d8a-43c5-8eb8-81ab33cc8602 0135-0515 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20101019 NDA NDA021330 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 4 mg/1 N 20181231 0135-0520_b8f344c6-3ae1-4968-b59e-e4fa6cba89e2 0135-0520 HUMAN OTC DRUG SENSODYNE PRONAMEL Fresh Breath potassium nitrate and sodium fluoride PASTE ORAL 20110414 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0521_032b6967-e3bb-4d2b-adca-ba78c2f4e98a 0135-0521 HUMAN OTC DRUG TUMS EX calcium carbonate TABLET ORAL 20110323 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0522_c7d8691d-c67b-4a32-a4f8-97ac4e525de0 0135-0522 HUMAN OTC DRUG Tums freshers calcium carbonate TABLET, CHEWABLE ORAL 20120202 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 500 mg/1 N 20181231 0135-0523_eadd6839-a269-4edd-9006-2382b2eef9bb 0135-0523 HUMAN OTC DRUG AQUAFRESH PURE BREATH ACTION sodium fluoride PASTE DENTAL 20110325 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.15 mg/g N 20181231 0135-0525_e1205168-1a5c-4e3e-b7a9-6b7c3d683de6 0135-0525 HUMAN OTC DRUG Sensodyne Extra Whitening potassium nitrate and sodium fluoride PASTE DENTAL 19900930 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0526_e1205168-1a5c-4e3e-b7a9-6b7c3d683de6 0135-0526 HUMAN OTC DRUG Sensodyne Original Flavor potassium nitrate and sodium fluoride PASTE DENTAL 19900930 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.3 mg/g; mg/g N 20181231 0135-0527_e1205168-1a5c-4e3e-b7a9-6b7c3d683de6 0135-0527 HUMAN OTC DRUG Sensodyne CoolGel potassium nitrate and sodium fluoride GEL DENTAL 19900930 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0528_e1205168-1a5c-4e3e-b7a9-6b7c3d683de6 0135-0528 HUMAN OTC DRUG Sensodyne Fresh Impact potassium nitrate and sodium fluoride PASTE DENTAL 20000701 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0529_e1205168-1a5c-4e3e-b7a9-6b7c3d683de6 0135-0529 HUMAN OTC DRUG Sensodyne Fresh Mint potassium nitrate and sodium fluoride PASTE DENTAL 19900930 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0531_07bfb6ab-064f-4ace-87eb-7981f2d99aeb 0135-0531 HUMAN OTC DRUG Aquafresh Extra Fresh Whitening sodium monofluorophosphate PASTE DENTAL 20120216 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g N 20181231 0135-0532_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0532 HUMAN OTC DRUG Nicorette Spearmint Burst nicotine polacrilex GUM, CHEWING ORAL 20170913 NDA NDA018612 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 2 mg/1 N 20181231 0135-0533_07970663-37a9-4ed2-af6a-d22a8d41d06e 0135-0533 HUMAN OTC DRUG Nicorette Spearmint Burst nicotine polacrilex GUM, CHEWING ORAL 20170913 NDA NDA020066 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC NICOTINE 4 mg/1 N 20181231 0135-0534_d1c6d524-9d29-46e9-be67-f36d3b6055c7 0135-0534 HUMAN OTC DRUG Aquafresh fresh n fruity sodium monofluorophosphate PASTE DENTAL 20120309 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM MONOFLUOROPHOSPHATE 1.1 mg/g N 20181231 0135-0537_775204b1-6909-4e75-a434-3022410cfaf3 0135-0537 HUMAN OTC DRUG PANADOL acetaminophen SUSPENSION ORAL 20121015 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN 160 mg/5mL N 20181231 0135-0539_a8ffbbb6-b63b-40cd-af7a-5ee81350f02f 0135-0539 HUMAN OTC DRUG PANADOL acetaminophen SUSPENSION ORAL 20121015 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare LP ACETAMINOPHEN 160 mg/5mL N 20181231 0135-0540_4868a9a5-9b6d-4613-8cb8-03b497cfceea 0135-0540 HUMAN OTC DRUG TUMS ULTRA calcium carbonate TABLET, CHEWABLE ORAL 20100212 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 0135-0541_c7d8691d-c67b-4a32-a4f8-97ac4e525de0 0135-0541 HUMAN OTC DRUG Tums freshers calcium carbonate TABLET, CHEWABLE ORAL 20130801 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 500 mg/1 N 20181231 0135-0544_a12475db-d4ec-412b-a571-20b86ccb429f 0135-0544 HUMAN OTC DRUG Aquafresh Big Kids sodium fluoride PASTE DENTAL 20140107 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.4 mg/g N 20181231 0135-0547_538b8a0e-2ce3-413b-93cb-0a7c931a1be9 0135-0547 HUMAN OTC DRUG SENSODYNE Repair and Protect Extra Fresh stannous fluoride PASTE ORAL 20130204 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC STANNOUS FLUORIDE 1.5 mg/g N 20181231 0135-0548_538b8a0e-2ce3-413b-93cb-0a7c931a1be9 0135-0548 HUMAN OTC DRUG SENSODYNE Repair and Protect stannous fluoride PASTE ORAL 20130204 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC STANNOUS FLUORIDE 1.5 mg/g N 20181231 0135-0550_8707ed4a-fd7c-48e0-a5a5-4e4304848580 0135-0550 HUMAN OTC DRUG Sensodyne potassium nitrate and sodium fluoride GEL DENTAL 20040217 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0551_8707ed4a-fd7c-48e0-a5a5-4e4304848580 0135-0551 HUMAN OTC DRUG Sensodyne potassium nitrate and sodium fluoride GEL DENTAL 20020102 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0557_9495b36d-16aa-4e65-bcda-bbc027146c4c 0135-0557 HUMAN OTC DRUG BIOTENE Fresh Mint Original sodium fluoride PASTE ORAL 20130715 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.5 mg/g N 20181231 0135-0558_9495b36d-16aa-4e65-bcda-bbc027146c4c 0135-0558 HUMAN OTC DRUG BIOTENE Gentle Mint sodium fluoride PASTE ORAL 20130715 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.5 mg/g N 20181231 0135-0560_e95c78b8-9436-4f3e-9835-ddb28effc625 0135-0560 HUMAN OTC DRUG Tums Chewy Delights calcium carbonate BAR, CHEWABLE ORAL 20130801 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 1177 mg/1 N 20181231 0135-0561_e95c78b8-9436-4f3e-9835-ddb28effc625 0135-0561 HUMAN OTC DRUG Tums Chewy Delights calcium carbonate BAR, CHEWABLE ORAL 20130801 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 1177 mg/1 N 20181231 0135-0563_eadd6839-a269-4edd-9006-2382b2eef9bb 0135-0563 HUMAN OTC DRUG AQUAFRESH CAVITY PROTECTION sodium fluoride PASTE DENTAL 20140509 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.13 mg/g N 20181231 0135-0564_eadd6839-a269-4edd-9006-2382b2eef9bb 0135-0564 HUMAN OTC DRUG AQUAFRESH EXTRA FRESH PLUS WHITENING sodium fluoride PASTE DENTAL 20140509 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.13 mg/g N 20181231 0135-0568_b8f344c6-3ae1-4968-b59e-e4fa6cba89e2 0135-0568 HUMAN OTC DRUG SENSODYNE PRONAMEL Multi Action potassium nitrate and sodium fluoride PASTE ORAL 20131209 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0569_e95c78b8-9436-4f3e-9835-ddb28effc625 0135-0569 HUMAN OTC DRUG Tums Chewy Delights calcium carbonate BAR, CHEWABLE ORAL 20140815 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 1177 mg/1 N 20181231 0135-0572_ba1628f5-2568-434a-a759-f63e7809ffec 0135-0572 HUMAN OTC DRUG Sensodyne Complete Protection Extra Fresh stannous fluoride PASTE DENTAL 20140714 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC STANNOUS FLUORIDE 1.5 mg/g N 20181231 0135-0573_ba1628f5-2568-434a-a759-f63e7809ffec 0135-0573 HUMAN OTC DRUG Sensodyne Complete Protection stannous fluoride PASTE DENTAL 20140714 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC STANNOUS FLUORIDE 1.5 mg/g N 20181231 0135-0574_cc005e91-b5ea-4509-8abc-e64f9805d756 0135-0574 HUMAN OTC DRUG GAVISCON aluminum hydroxide and magnesium carbonate LIQUID ORAL 20140801 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 254; 237.5 mg/5mL; mg/5mL N 20181231 0135-0575_538b8a0e-2ce3-413b-93cb-0a7c931a1be9 0135-0575 HUMAN OTC DRUG SENSODYNE Repair and Protect Whitening stannous fluoride PASTE ORAL 20150119 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC STANNOUS FLUORIDE 1.5 mg/g N 20181231 0135-0576_5ee4fe65-6825-4365-bc3b-38d0883fb6d6 0135-0576 HUMAN OTC DRUG FLONASE ALLERGY RELIEF fluticasone propionate SPRAY, METERED NASAL 20141204 NDA NDA205434 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC FLUTICASONE PROPIONATE 50 ug/1 N 20181231 0135-0577_907b0d6b-e1d2-431e-82cf-9be27f8ac1d7 0135-0577 HUMAN OTC DRUG biotene sodium monofluorophosphate PASTE ORAL 20160901 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 0135-0579_8d120666-6ec0-4b08-b91e-7654f79b954b 0135-0579 HUMAN OTC DRUG Sensodyne True white potassium nitrate and sodium fluoride PASTE DENTAL 20151221 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.6 mg/g; mg/g N 20181231 0135-0581_8d120666-6ec0-4b08-b91e-7654f79b954b 0135-0581 HUMAN OTC DRUG Sensodyne True white potassium nitrate and sodium fluoride PASTE DENTAL 20151221 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.6 mg/g; mg/g N 20181231 0135-0582_b4b12f0c-1bd3-43f8-8b50-2a569a15d503 0135-0582 HUMAN OTC DRUG CHILDRENS FLONASE ALLERGY RELIEF fluticasone propionate SPRAY, METERED NASAL 20160229 NDA NDA205434 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC FLUTICASONE PROPIONATE 50 ug/1 N 20181231 0135-0586_eadd6839-a269-4edd-9006-2382b2eef9bb 0135-0586 HUMAN OTC DRUG AQUAFRESH Whitening Multi Action sodium fluoride PASTE DENTAL 20151016 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.1 mg/g N 20181231 0135-0588_81d0c3b4-f748-4a11-9d3e-df8b3c802483 0135-0588 HUMAN OTC DRUG SENSODYNE PRONAMEL 6 to 12 years sodium fluoride PASTE ORAL 20151221 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.5 mg/g N 20181231 0135-0589_536c4338-d824-4697-87a7-db51a0bcae47 0135-0589 HUMAN OTC DRUG Nicorette and Aquafresh Fruit Chill and Extreme Clean Whitening nicotine polacrilex and sodium fluoride KIT 20151207 NDA NDA020066 GlaxoSmithKline Consumer Healthcare LP N 20181231 0135-0590_3ece36b2-d15b-4402-9f08-b881a939c38e 0135-0590 HUMAN OTC DRUG AQUAFRESH CAVITY PROTECTION sodium fluoride PASTE DENTAL 20161001 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.5 mg/g N 20181231 0135-0591_3ece36b2-d15b-4402-9f08-b881a939c38e 0135-0591 HUMAN OTC DRUG AQUAFRESH EXTRA FRESH PLUS WHITENING sodium fluoride PASTE DENTAL 20140509 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.5 mg/g N 20181231 0135-0592_3ece36b2-d15b-4402-9f08-b881a939c38e 0135-0592 HUMAN OTC DRUG AQUAFRESH ultimate white sodium fluoride PASTE DENTAL 20170131 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.5 mg/g N 20181231 0135-0593_8c1e7159-c30d-4b95-9e95-1911fabfd5e8 0135-0593 HUMAN OTC DRUG sensodyne potassium nitrate and sodium fluoride PASTE DENTAL 20161219 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.6 mg/g; mg/g N 20181231 0135-0594_3ece36b2-d15b-4402-9f08-b881a939c38e 0135-0594 HUMAN OTC DRUG AQUAFRESH MULTI ACTION WHITENING sodium fluoride PASTE DENTAL 20170131 OTC MONOGRAPH FINAL part355 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC SODIUM FLUORIDE 1.5 mg/g N 20181231 0135-0598_0f07aa1a-97be-44af-92d8-a10777e24e0a 0135-0598 HUMAN OTC DRUG parodontax stannous fluoride PASTE DENTAL 20161219 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC STANNOUS FLUORIDE 1.5 mg/g N 20181231 0135-0599_0f07aa1a-97be-44af-92d8-a10777e24e0a 0135-0599 HUMAN OTC DRUG parodontax stannous fluoride PASTE DENTAL 20161219 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC STANNOUS FLUORIDE 1.5 mg/g N 20181231 0135-0601_0f07aa1a-97be-44af-92d8-a10777e24e0a 0135-0601 HUMAN OTC DRUG parodontax stannous fluoride PASTE DENTAL 20161219 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC STANNOUS FLUORIDE 1.5 mg/g N 20181231 0135-0602_be1ae382-0e01-4db8-90d7-fdadec2ff861 0135-0602 HUMAN OTC DRUG Sensodyne Pronamel Strong and Bright Enamel Mint potassium nitrate and sodium fluoride PASTE ORAL 20161219 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0603_be1ae382-0e01-4db8-90d7-fdadec2ff861 0135-0603 HUMAN OTC DRUG Sensodyne Pronamel Strong and Bright Enamel Extra Fresh potassium nitrate and sodium fluoride PASTE ORAL 20161219 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0605_83e40989-0833-488b-8b21-8471e519cd2d 0135-0605 HUMAN OTC DRUG AQUAFRESH SENSITIVE MAXIMUM STRENGTH potassium nitrate and sodium fluoride PASTE DENTAL 20170217 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 0135-0606_54932beb-7a89-4a44-a71e-bd4d036c6f0f 0135-0606 HUMAN OTC DRUG Tums Chewy Bites calcium carbonate TABLET, CHEWABLE ORAL 20170301 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0607_f626ab17-01c9-4493-ba9e-0c8c11146384 0135-0607 HUMAN OTC DRUG Panadol Cold and Flu NonDrowsy acetaminophen and phenyleprine HCl TABLET, FILM COATED ORAL 20170601 OTC MONOGRAPH FINAL part341 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 0135-0608_a62af3be-b468-4faf-98f9-645ec60d544e 0135-0608 HUMAN OTC DRUG PANADOL PM acetaminophen and diphenhydramine HCl TABLET, FILM COATED ORAL 20161201 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0135-0609_00f0ee4f-1fd8-4f0b-b1a3-8072d0f884c3 0135-0609 HUMAN OTC DRUG PANADOL Extra Strength acetaminophen TABLET, FILM COATED ORAL 20170315 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN 500 mg/1 N 20181231 0135-0610_ee3faeab-4cea-4852-9ddf-901a346c092a 0135-0610 HUMAN OTC DRUG TUMS ULTRA calcium carbonate TABLET, CHEWABLE ORAL 20160901 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 0135-0611_ac80f627-3f51-425b-8c75-e07363048b00 0135-0611 HUMAN OTC DRUG Tums Regular Strength calcium carbonate TABLET, CHEWABLE ORAL 20160901 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 500 mg/1 N 20181231 0135-0612_ee3faeab-4cea-4852-9ddf-901a346c092a 0135-0612 HUMAN OTC DRUG TUMS ULTRA calcium carbonate TABLET, CHEWABLE ORAL 20160901 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 0135-0615_40b990e2-8f01-4d95-ab14-dcfa624f92c6 0135-0615 HUMAN OTC DRUG FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED NASAL 20170201 NDA NDA022051 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC FLUTICASONE FUROATE 27.5 ug/1 N 20181231 0135-0616_893234b5-be82-4425-b850-2b884637b18e 0135-0616 HUMAN OTC DRUG FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED NASAL 20170701 NDA NDA022051 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC FLUTICASONE FUROATE 27.5 ug/1 N 20181231 0135-0618_453ceee1-414b-4f4c-8408-eb540a79ca05 0135-0618 HUMAN OTC DRUG Tums Chewy Bites calcium carbonate TABLET, CHEWABLE ORAL 20170518 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0135-0620_e5c2d88a-d903-4ca0-b895-f27e791dfc4e 0135-0620 HUMAN OTC DRUG PANADOL Extra acetaminophen and caffeine TABLET, FILM COATED ORAL 20170301 OTC MONOGRAPH NOT FINAL part343 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 0135-0621_641c6803-d53f-4c8a-bb08-eb9b4b5e095c 0135-0621 HUMAN OTC DRUG SENSODYNE Rapid Relief stannous fluoride PASTE ORAL 20180108 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC STANNOUS FLUORIDE 1.5 mg/g N 20181231 0135-0622_641c6803-d53f-4c8a-bb08-eb9b4b5e095c 0135-0622 HUMAN OTC DRUG SENSODYNE Rapid Relief stannous fluoride PASTE ORAL 20180108 OTC MONOGRAPH NOT FINAL part356 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC STANNOUS FLUORIDE 1.5 mg/g N 20181231 0135-0623_54932beb-7a89-4a44-a71e-bd4d036c6f0f 0135-0623 HUMAN OTC DRUG Tums Chewy Bites calcium carbonate TABLET, CHEWABLE ORAL 20171001 OTC MONOGRAPH FINAL part331 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC CALCIUM CARBONATE 750 mg/1 N 20181231 0140-0004_c37701d6-b0f8-4dfa-a064-08c13b501296 0140-0004 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 19631115 NDA NDA013263 Roche Laboratories Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0140-0005_c37701d6-b0f8-4dfa-a064-08c13b501296 0140-0005 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 19631115 NDA NDA013263 Roche Laboratories Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0140-0006_c37701d6-b0f8-4dfa-a064-08c13b501296 0140-0006 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 19631115 NDA NDA013263 Roche Laboratories Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0143-0170_d7673793-e24d-42ec-a984-2e73992fa8aa 0143-0170 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine CAPSULE ORAL 19981028 ANDA ANDA040261 West-Ward Pharmaceutical Corp BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 500; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0143-1140_88a8ad45-3957-45b0-ae70-d0a11ba0aef9 0143-1140 HUMAN PRESCRIPTION DRUG Belladonna Alkaloids with Phenobarbital Belladonna Alkaloids with Phenobarbital TABLET ORAL 19660101 UNAPPROVED DRUG OTHER West-Ward Pharmaceuticals Corp HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE; PHENOBARBITAL .1037; .0194; .0065; 16.2 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0143-1171_7bf1d42c-6b9c-49ea-a263-044437d07b70 0143-1171 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 West-Ward Pharmaceuticals Corp CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 0143-1172_7bf1d42c-6b9c-49ea-a263-044437d07b70 0143-1172 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 West-Ward Pharmaceuticals Corp CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 0143-1173_7bf1d42c-6b9c-49ea-a263-044437d07b70 0143-1173 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 West-Ward Pharmaceuticals Corp CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 0143-1174_7bf1d42c-6b9c-49ea-a263-044437d07b70 0143-1174 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 West-Ward Pharmaceuticals Corp CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 0143-1176_9eea67b8-6034-4967-b398-bfaa2d117269 0143-1176 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19960124 ANDA ANDA040124 West-Ward Pharmaceuticals Corp CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 0143-1195_6c3b6cb9-0270-4ce5-aa51-fc8834f39880 0143-1195 HUMAN PRESCRIPTION DRUG Chloroquine Chloroquine Phosphate TABLET ORAL 19750709 ANDA ANDA083082 West-ward Pharmaceutical Corp CHLOROQUINE PHOSPHATE 250 mg/1 Antimalarial [EPC] N 20181231 0143-1202_81505329-962c-4f65-ab24-f64007740e32 0143-1202 HUMAN PRESCRIPTION DRUG Cortisone Acetate Cortisone Acetate TABLET ORAL 19720613 ANDA ANDA080776 West-ward Pharmaceutical Corp CORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0143-1209_2af0405e-71c2-4074-bbd2-41ef19697dd0 0143-1209 HUMAN PRESCRIPTION DRUG Chlorothiazide Chlorothiazide TABLET ORAL 20050830 ANDA ANDA086028 West-ward Pharmaceutical Corp CHLOROTHIAZIDE 250 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0143-1210_2af0405e-71c2-4074-bbd2-41ef19697dd0 0143-1210 HUMAN PRESCRIPTION DRUG Chlorothiazide Chlorothiazide TABLET ORAL 20050830 ANDA ANDA087736 West-ward Pharmaceutical Corp CHLOROTHIAZIDE 500 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0143-1227_ad8d8eca-e680-459b-81cb-84b58548f5d3 0143-1227 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 West-ward Pharmaceutical Corp DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0143-1240_a0359ff2-21e7-43f5-901a-ab7929d1be7b 0143-1240 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 West-Ward Pharmaceuticals Corp DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20191231 0143-1241_a0359ff2-21e7-43f5-901a-ab7929d1be7b 0143-1241 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 West-Ward Pharmaceuticals Corp DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20191231 0143-1246_18cc54af-63ba-47f7-a805-66b2da1f522e 0143-1246 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate Fludrocortisone Acetate TABLET ORAL 20110722 ANDA ANDA091302 West-ward Pharmaceutical Corp FLUDROCORTISONE ACETATE .1 mg/1 N 20181231 0143-1250_6ce73874-823f-4018-9a79-98c99897a2ec 0143-1250 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20090305 ANDA ANDA040836 West-ward Pharmaceutical Corp GLYCOPYRROLATE 1 mg/1 N 20181231 0143-1251_6ce73874-823f-4018-9a79-98c99897a2ec 0143-1251 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20090305 ANDA ANDA040836 West-ward Pharmaceutical Corp GLYCOPYRROLATE 2 mg/1 N 20181231 0143-1252_c5eab696-229d-48e5-9a22-ed93c2e60b6e 0143-1252 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 20150223 ANDA ANDA083365 West-Ward Pharmaceuticals Corp HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0143-1253_c5eab696-229d-48e5-9a22-ed93c2e60b6e 0143-1253 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 20150223 ANDA ANDA083365 West-Ward Pharmaceuticals Corp HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0143-1254_c5eab696-229d-48e5-9a22-ed93c2e60b6e 0143-1254 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 19730618 ANDA ANDA083365 West-Ward Pharmaceuticals Corp HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0143-1256_41215fb1-eeae-491d-99b7-766303842823 0143-1256 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20060801 ANDA ANDA084878 West-ward Pharmaceutical Corp HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0143-1257_41215fb1-eeae-491d-99b7-766303842823 0143-1257 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19770201 ANDA ANDA084878 West-ward Pharmaceutical Corp HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0143-1260_9ecafdbc-ec13-4a4c-a62f-6f8297be3060 0143-1260 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720228 ANDA ANDA080212 West-Ward Pharmaceuticals Corp ISONIAZID 100 mg/1 Antimycobacterial [EPC] N 20181231 0143-1261_9ecafdbc-ec13-4a4c-a62f-6f8297be3060 0143-1261 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19810714 ANDA ANDA087425 West-Ward Pharmaceuticals Corp ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 0143-1262_4b5d5eb3-761f-4196-a446-3278ad505015 0143-1262 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 West-Ward Pharmaceuticals Corp HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0143-1263_4b5d5eb3-761f-4196-a446-3278ad505015 0143-1263 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 West-Ward Pharmaceuticals Corp HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0143-1264_4b5d5eb3-761f-4196-a446-3278ad505015 0143-1264 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 West-Ward Pharmaceuticals Corp HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0143-1266_1c48387b-7709-447f-96dc-6b3bacf3ac50 0143-1266 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 West-Ward Pharmaceuticals Corp LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0143-1267_1c48387b-7709-447f-96dc-6b3bacf3ac50 0143-1267 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 West-Ward Pharmaceuticals Corp LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0143-1268_1c48387b-7709-447f-96dc-6b3bacf3ac50 0143-1268 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 West-Ward Pharmaceuticals Corp LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0143-1270_1c48387b-7709-447f-96dc-6b3bacf3ac50 0143-1270 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 West-Ward Pharmaceuticals Corp LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0143-1277_760bee09-05a4-4a0d-bff8-4cc2540575ad 0143-1277 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20020906 ANDA ANDA076490 West-Ward Pharmaceutical Corp LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] N 20181231 0143-1282_9aaaf269-6535-48d6-be86-eb30c2732a86 0143-1282 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride TABLET ORAL 20100421 ANDA ANDA077699 West-Ward Pharmaceuticals Corp MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] N 20181231 0143-1290_03662479-26e1-4986-a484-bb85e1ac0fe5 0143-1290 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 West-Ward Pharmaceuticals Corp METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0143-1292_03662479-26e1-4986-a484-bb85e1ac0fe5 0143-1292 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 West-Ward Pharmaceuticals Corp METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0143-1300_f27a8c61-3d94-4e67-ade6-7602badc6e0a 0143-1300 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 20101228 ANDA ANDA078715 West-Ward Pharmaceutical Corp LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 0143-1333_68b9d139-fbb3-44f1-9933-96598c04dd56 0143-1333 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, COATED ORAL 20001005 ANDA ANDA075361 West-ward Pharmaceutical Corp ISOSORBIDE MONONITRATE 20 mg/1 N 20181231 0143-1346_d3608c5b-5040-4857-aa95-f1875166a035 0143-1346 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040114 ANDA ANDA076494 West-Ward Pharmaceuticals Corp NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0143-1347_d3608c5b-5040-4857-aa95-f1875166a035 0143-1347 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040114 ANDA ANDA076494 West-Ward Pharmaceuticals Corp NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0143-1348_d3608c5b-5040-4857-aa95-f1875166a035 0143-1348 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040114 ANDA ANDA076494 West-Ward Pharmaceuticals Corp NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0143-1445_752b72df-c820-42d7-85c7-c4ab9caf3d3e 0143-1445 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER West-Ward Pharmaceuticals Corp PHENOBARBITAL 15 mg/1 CIV N 20181231 0143-1450_752b72df-c820-42d7-85c7-c4ab9caf3d3e 0143-1450 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER West-Ward Pharmaceuticals Corp PHENOBARBITAL 30 mg/1 CIV N 20181231 0143-1455_752b72df-c820-42d7-85c7-c4ab9caf3d3e 0143-1455 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER West-Ward Pharmaceuticals Corp PHENOBARBITAL 60 mg/1 CIV N 20181231 0143-1458_752b72df-c820-42d7-85c7-c4ab9caf3d3e 0143-1458 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER West-Ward Pharmaceuticals Corp PHENOBARBITAL 100 mg/1 CIV N 20181231 0143-1480_7a31f17a-308c-45c5-b0d2-7a825de2a619 0143-1480 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 19710723 ANDA ANDA080154 West-Ward Pharmaceutical Corp PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 0143-1482_7d2a9a3b-a440-422e-afa1-7a4d41c2226a 0143-1482 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20060701 ANDA ANDA040667 West-ward Pharmaceutical Corp PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0143-1484_7d2a9a3b-a440-422e-afa1-7a4d41c2226a 0143-1484 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20060701 ANDA ANDA040667 West-ward Pharmaceutical Corp PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0143-1763_eb5e1442-b994-478a-8f26-64cbfbd06eb5 0143-1763 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20000216 ANDA ANDA040337 West-ward Pharmaceutical Corp TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 N 20181231 0143-1764_eb5e1442-b994-478a-8f26-64cbfbd06eb5 0143-1764 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20000216 ANDA ANDA040337 West-ward Pharmaceutical Corp TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 0143-1765_b7c4af42-2c43-4c96-8c33-3711f10cb904 0143-1765 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET SUBLINGUAL 19781201 ANDA ANDA086054 West-ward Pharmaceutical Corp ISOSORBIDE DINITRATE 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0143-1767_b7c4af42-2c43-4c96-8c33-3711f10cb904 0143-1767 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET SUBLINGUAL 19781201 ANDA ANDA086055 West-ward Pharmaceutical Corp ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0143-1769_10e4e800-d5c7-4420-9ddb-4a974ea0a836 0143-1769 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086067 West-Ward Pharmaceuticals Corp ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 0143-1771_10e4e800-d5c7-4420-9ddb-4a974ea0a836 0143-1771 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086066 West-Ward Pharmaceuticals Corp ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 0143-1772_10e4e800-d5c7-4420-9ddb-4a974ea0a836 0143-1772 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19830426 ANDA ANDA088088 West-Ward Pharmaceuticals Corp ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 0143-1773_1bf5a3aa-3342-429a-8bd2-1d16550ba5c7 0143-1773 HUMAN PRESCRIPTION DRUG Isosorrbide Dinitrate Isosorbdie Dinitrate TABLET ORAL 20070110 ANDA ANDA040591 West-ward Pharmaceutical Corp ISOSORBIDE DINITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0143-1785_576e3e85-d465-4c0f-9d8a-3a786e2becd2 0143-1785 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 19790605 ANDA ANDA086162 West-ward Pharmaceutical Corp BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 0143-1787_5868d762-3d56-4d80-9f06-d87f514d8b24 0143-1787 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 West-Ward Pharmaceuticals Corp BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0143-2037_037e496d-acee-497d-b039-e37c3d293e4f 0143-2037 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 West-ward Pharmaceutical Corp CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0143-2112_c4aa779a-2869-4e04-b716-6105f448b8ee 0143-2112 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 West-Ward Pharmaceuticals Corp DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0143-2120_2dd70d46-765d-434d-92e6-4f8974dc31af 0143-2120 HUMAN PRESCRIPTION DRUG ERGOTAMINE ergotamine tartrate and caffeine TABLET, FILM COATED ORAL 20040917 ANDA ANDA040510 West-Ward Pharmaceutical Corp ERGOTAMINE TARTRATE; CAFFEINE 1; 100 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0143-2125_6c3b6cb9-0270-4ce5-aa51-fc8834f39880 0143-2125 HUMAN PRESCRIPTION DRUG Chloroquine Chloroquine Phosphate TABLET, COATED ORAL 19990917 ANDA ANDA083082 West-ward Pharmaceutical Corp CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] N 20181231 0143-2128_a631870d-2d3d-4ade-a23f-23d9a8a22f45 0143-2128 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20070815 ANDA ANDA040760 West-ward Pharmaceutical Corp HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 0143-2230_199c345b-76f3-4e62-ba99-4cd60b5f652a 0143-2230 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060330 ANDA ANDA076813 West-Ward Pharmaceuticals Corp ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0143-2260_199c345b-76f3-4e62-ba99-4cd60b5f652a 0143-2260 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060330 ANDA ANDA076813 West-Ward Pharmaceuticals Corp ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0143-2422_ebd1e2c0-535e-4fd7-b679-177e91e68687 0143-2422 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron hydrochloride TABLET ORAL 20080101 ANDA ANDA077545 West-ward Pharmaceutical Corp ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0143-2423_ebd1e2c0-535e-4fd7-b679-177e91e68687 0143-2423 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron hydrochloride TABLET ORAL 20080101 ANDA ANDA077545 West-ward Pharmaceutical Corp ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0143-2424_ebd1e2c0-535e-4fd7-b679-177e91e68687 0143-2424 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET ORAL 20080101 ANDA ANDA077545 West-ward Pharmaceutical Corp ONDANSETRON HYDROCHLORIDE 24 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0143-3018_bd73a8b1-1fca-4d09-8f94-4339cf39d880 0143-3018 HUMAN PRESCRIPTION DRUG Colchicine Colchicine CAPSULE ORAL 20141001 NDA NDA204820 West-Ward Pharmaceuticals Corp COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20181231 0143-3107_9c2097c3-1d9a-4673-bcf5-addeae1ca6b0 0143-3107 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20170811 ANDA ANDA209256 West-Ward Pharmaceuticals Corp PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0143-3108_9c2097c3-1d9a-4673-bcf5-addeae1ca6b0 0143-3108 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20170811 ANDA ANDA209256 West-Ward Pharmaceuticals Corp PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0143-3125_e77821f2-101f-4189-873c-ed9065083bb9 0143-3125 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20071126 ANDA ANDA077885 West-ward Pharmaceutical Corp HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0143-3126_ad8d8eca-e680-459b-81cb-84b58548f5d3 0143-3126 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19970228 ANDA ANDA040204 West-ward Pharmaceutical Corp DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0143-3141_1a551d84-90de-48c4-a6a3-cc02bc9e10a4 0143-3141 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19841107 ANDA ANDA062396 West-Ward Pharmaceuticals Corp DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 0143-3142_1a551d84-90de-48c4-a6a3-cc02bc9e10a4 0143-3142 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 West-Ward Pharmaceuticals Corp DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0143-3145_136d6fb7-9453-4b03-bcb6-6bb1152fdcc3 0143-3145 HUMAN OTC DRUG Ephedrine Sulfate Ephedrine Sulfate CAPSULE ORAL 19930901 OTC MONOGRAPH FINAL part310.533 West-ward Pharmaceutical Corp EPHEDRINE SULFATE 25 mg/1 N 20181231 0143-3188_731ddc26-5659-437b-ab5d-44f4d59255b3 0143-3188 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20030301 ANDA ANDA076243 West-Ward Pharmaceuticals Corp LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] N 20181231 0143-3189_731ddc26-5659-437b-ab5d-44f4d59255b3 0143-3189 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20030301 ANDA ANDA076243 West-Ward Pharmaceuticals Corp LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 0143-3190_731ddc26-5659-437b-ab5d-44f4d59255b3 0143-3190 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20020501 ANDA ANDA078763 West-Ward Pharmaceuticals Corp LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] N 20181231 0143-3367_3897b6f0-5a9e-4ea1-8f4e-c8cc47547d19 0143-3367 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA077107 West-ward Pharmaceutical Corp FLURAZEPAM HYDROCHLORIDE 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0143-3370_3897b6f0-5a9e-4ea1-8f4e-c8cc47547d19 0143-3370 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA071108 West-ward Pharmaceutical Corp FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0143-3991_164477b7-26bf-4c39-b2ac-d086ec30a07d 0143-3991 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 West-ward Pharmaceutical Corp GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0143-3993_164477b7-26bf-4c39-b2ac-d086ec30a07d 0143-3993 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 West-ward Pharmaceutical Corp GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0143-3994_164477b7-26bf-4c39-b2ac-d086ec30a07d 0143-3994 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 West-ward Pharmaceutical Corp GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0143-9130_75e775c1-b2da-4b93-9dd8-1903de92fcc8 0143-9130 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20060727 ANDA ANDA077836 West-ward Pharmaceutical Corp GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 0143-9202_ff0d077f-fed8-4f16-b8d7-5822ae4a4262 0143-9202 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION INTRAVENOUS 20070807 ANDA ANDA065289 West-Ward Pharmaceuticals Corp EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0143-9203_ff0d077f-fed8-4f16-b8d7-5822ae4a4262 0143-9203 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION INTRAVENOUS 20070807 ANDA ANDA065289 West-Ward Pharmaceuticals Corp EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0143-9209_fc423001-ccbd-4bd2-96f2-3a3c484cd078 0143-9209 HUMAN PRESCRIPTION DRUG Chloroprocaine Hydrochloride Chloroprocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 19981101 ANDA ANDA040273 West-Ward Pharmaceuticals Corp CHLOROPROCAINE HYDROCHLORIDE 20 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0143-9210_fc423001-ccbd-4bd2-96f2-3a3c484cd078 0143-9210 HUMAN PRESCRIPTION DRUG Chloroprocaine Hydrochloride Chloroprocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 19981101 ANDA ANDA040273 West-Ward Pharmaceuticals Corp CHLOROPROCAINE HYDROCHLORIDE 30 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0143-9217_9b818a39-f5a4-4d46-9407-f1e8265fa897 0143-9217 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20170130 ANDA ANDA065275 West-Ward Pharmaceuticals Corp IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0143-9218_9b818a39-f5a4-4d46-9407-f1e8265fa897 0143-9218 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20170130 ANDA ANDA065275 West-Ward Pharmaceuticals Corp IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0143-9219_9b818a39-f5a4-4d46-9407-f1e8265fa897 0143-9219 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20170130 ANDA ANDA065275 West-Ward Pharmaceuticals Corp IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0143-9230_6a8b01bb-ec16-43eb-9339-fe9bd30083e4 0143-9230 HUMAN PRESCRIPTION DRUG Rifampin Rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160303 ANDA ANDA205039 West-Ward Pharmaceuticals Corp RIFAMPIN 600 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 0143-9240_410de9a9-6bb4-453b-9543-bf8341ee9084 0143-9240 HUMAN PRESCRIPTION DRUG Bleomycin Bleomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20180109 ANDA ANDA065042 West-Ward Pharmaceuticals Corp BLEOMYCIN SULFATE 15 [USP'U]/1 Cytoprotective Agent [EPC] N 20191231 0143-9241_410de9a9-6bb4-453b-9543-bf8341ee9084 0143-9241 HUMAN PRESCRIPTION DRUG Bleomycin Bleomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20180109 ANDA ANDA065042 West-Ward Pharmaceuticals Corp BLEOMYCIN SULFATE 30 [USP'U]/1 Cytoprotective Agent [EPC] N 20191231 0143-9247_bd949996-45aa-4193-a953-db5979a2f8f5 0143-9247 HUMAN PRESCRIPTION DRUG Dexrazoxane Dexrazoxane INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050331 ANDA ANDA076068 West-Ward Pharmaceuticals Corp DEXRAZOXANE HYDROCHLORIDE 10 mg/mL Cytoprotective Agent [EPC] N 20181231 0143-9248_bd949996-45aa-4193-a953-db5979a2f8f5 0143-9248 HUMAN PRESCRIPTION DRUG Dexrazoxane Dexrazoxane INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050331 ANDA ANDA076068 West-Ward Pharmaceuticals Corp DEXRAZOXANE HYDROCHLORIDE 10 mg/mL Cytoprotective Agent [EPC] N 20181231 0143-9249_3def549f-538f-4647-8606-cf48f2f477ad 0143-9249 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET ORAL 20160823 ANDA ANDA203824 West-Ward Pharmaceuticals Corp AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0143-9250_8da5e550-3ad7-491c-a548-7b8183ba2a8f 0143-9250 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION INTRAVENOUS 20170430 ANDA ANDA204679 West-Ward Pharmaceuticals Corp ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0143-9251_8da5e550-3ad7-491c-a548-7b8183ba2a8f 0143-9251 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION INTRAVENOUS 20170430 ANDA ANDA204679 West-Ward Pharmaceuticals Corp ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0143-9261_11006e08-f30d-4098-9cf2-c632fbe4a1e9 0143-9261 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20041018 ANDA ANDA065143 West-Ward Pharmaceuticals Corp CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9262_21ec2f66-0c27-49fc-ab5f-508356ac050c 0143-9262 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010918 ANDA ANDA065047 West-Ward Pharmaceuticals Corp CEFAZOLIN SODIUM 330 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9273_12a3970a-258a-43e2-b57a-840778c58d7c 0143-9273 HUMAN PRESCRIPTION DRUG Dihydroergotamine Mesylate Dihydroergotamine Mesylate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20170915 ANDA ANDA206621 West-Ward Pharmaceuticals Corp DIHYDROERGOTAMINE MESYLATE 1 mg/mL Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient] N 20181231 0143-9284_2534be2c-aae8-4468-8c97-52f66d8002e5 0143-9284 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170922 NDA NDA209463 West-Ward Pharmaceuticals Corp PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 0143-9288_b992a541-11a4-4f87-a28e-dfeff905eb68 0143-9288 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20120105 NDA NDA203049 West-Ward Pharmaceuticals Corp ARGATROBAN 250 mg/2.5mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 0143-9297_a9821c7e-0ae7-4515-b8eb-4d32b2030a75 0143-9297 HUMAN PRESCRIPTION DRUG Dantrolene Dantrolene INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170619 ANDA ANDA204762 West-Ward Pharmaceuticals Corp DANTROLENE SODIUM 20 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 0143-9298_0bc80e01-13ee-4a05-92e1-d49763ce9884 0143-9298 HUMAN PRESCRIPTION DRUG Sodium Ferric Gluconate Complex in Sucrose Sodium Ferric Gluconate Complex in Sucrose INJECTION INTRAVENOUS 20110331 ANDA ANDA078215 West-Ward Pharmaceuticals Corp SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0143-9300_dbab3be4-08b0-46df-91bf-8f1dd00918c8 0143-9300 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170922 NDA NDA209463 West-Ward Pharmaceuticals Corp PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 0143-9306_2c0634c5-3ea9-4d75-8dfe-fd7fe7d07bd2 0143-9306 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20180112 ANDA ANDA065275 West-Ward Pharmaceuticals Corp IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20191231 0143-9307_2c0634c5-3ea9-4d75-8dfe-fd7fe7d07bd2 0143-9307 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20180112 ANDA ANDA065275 West-Ward Pharmaceuticals Corp IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20191231 0143-9308_2c0634c5-3ea9-4d75-8dfe-fd7fe7d07bd2 0143-9308 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20180112 ANDA ANDA065275 West-Ward Pharmaceuticals Corp IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20191231 0143-9501_18660333-f462-4443-82de-f2cc0d65c61d 0143-9501 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol lactate INJECTION INTRAMUSCULAR 20010619 ANDA ANDA075858 West-Ward Pharmaceuticals Corp HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20191231 0143-9502_18660333-f462-4443-82de-f2cc0d65c61d 0143-9502 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol Lactate INJECTION INTRAMUSCULAR 20010619 ANDA ANDA075858 West-Ward Pharmaceuticals Corp HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20191231 0143-9503_cc3bb159-c56c-4029-ac13-0e7d55eedcf2 0143-9503 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE Acetazolamide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960501 ANDA ANDA040089 West-Ward Pharmaceuticals Corp ACETAZOLAMIDE SODIUM 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 0143-9506_07c20c99-3e27-4d92-9617-4cdbd03340c5 0143-9506 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION INTRAVENOUS 20160225 ANDA ANDA202354 West-Ward Pharmaceuticals Corp ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 0143-9507_07c20c99-3e27-4d92-9617-4cdbd03340c5 0143-9507 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION INTRAVENOUS 20160225 ANDA ANDA202354 West-Ward Pharmaceuticals Corp ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 0143-9508_7e851ba9-c32b-4c36-87d1-584dde4aa4c7 0143-9508 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride Ketamine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19960701 ANDA ANDA074524 West-Ward Pharmaceuticals Corp KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 0143-9509_7e851ba9-c32b-4c36-87d1-584dde4aa4c7 0143-9509 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride Ketamine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19960701 ANDA ANDA074524 West-Ward Pharmaceuticals Corp KETAMINE HYDROCHLORIDE 100 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 0143-9510_8b189999-6137-4ced-b3f3-14b2a828a607 0143-9510 HUMAN PRESCRIPTION DRUG Etoposide Etoposide INJECTION INTRAVENOUS 19960501 ANDA ANDA074290 West-Ward Pharmaceuticals Corp ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0143-9511_8b189999-6137-4ced-b3f3-14b2a828a607 0143-9511 HUMAN PRESCRIPTION DRUG Etoposide Etoposide INJECTION INTRAVENOUS 19970201 ANDA ANDA074290 West-Ward Pharmaceuticals Corp ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0143-9512_8b189999-6137-4ced-b3f3-14b2a828a607 0143-9512 HUMAN PRESCRIPTION DRUG Etoposide Etoposide INJECTION INTRAVENOUS 19970201 ANDA ANDA074290 West-Ward Pharmaceuticals Corp ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0143-9513_c9e3fd8c-f88e-45a2-9f44-421021808ee2 0143-9513 HUMAN PRESCRIPTION DRUG Palonosetron Hydrochloride Palonosetron Hydrochloride INJECTION INTRAVENOUS 20170901 NDA NDA207963 West-Ward Pharmaceuticals Corp PALONOSETRON HYDROCHLORIDE .25 mg/2mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0143-9516_637d736f-602f-484b-b7da-711f39b18c6b 0143-9516 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20180105 ANDA ANDA089343 West-Ward Pharmaceuticals Corp METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20191231 0143-9517_637d736f-602f-484b-b7da-711f39b18c6b 0143-9517 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20180105 ANDA ANDA089342 West-Ward Pharmaceuticals Corp METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20191231 0143-9518_637d736f-602f-484b-b7da-711f39b18c6b 0143-9518 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20180105 ANDA ANDA089341 West-Ward Pharmaceuticals Corp METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20191231 0143-9519_637d736f-602f-484b-b7da-711f39b18c6b 0143-9519 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20171010 ANDA ANDA089340 West-Ward Pharmaceuticals Corp METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20191231 0143-9529_f02080c3-c9f8-40af-b53d-e9fbfa4fce8c 0143-9529 HUMAN PRESCRIPTION DRUG Fluphenazine Decanoate Fluphenazine Decanoate INJECTION INTRAMUSCULAR; SUBCUTANEOUS 19960830 ANDA ANDA074531 West-Ward Pharmaceuticals Corp FLUPHENAZINE DECANOATE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0143-9530_fd5ae784-0c46-4948-ae2c-1e004efb0a57 0143-9530 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION INTRAVENOUS 20170610 ANDA ANDA076619 West-Ward Pharmaceuticals Corp IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0143-9531_fd5ae784-0c46-4948-ae2c-1e004efb0a57 0143-9531 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION INTRAVENOUS 20170610 ANDA ANDA076619 West-Ward Pharmaceuticals Corp IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0143-9532_81a7a5fa-2eaa-430c-bdb7-667a1c8a362b 0143-9532 HUMAN PRESCRIPTION DRUG Dexmedetomidine HCl Dexmedetomidine HCl INJECTION INTRAVENOUS 20170426 ANDA ANDA205046 West-Ward Pharmaceuticals Corp DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 0143-9533_5c4d416f-e181-4025-b89d-4edada3420b3 0143-9533 HUMAN PRESCRIPTION DRUG Allopurinol sodium Allopurinol sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20040901 ANDA ANDA076870 West-Ward Pharmaceuticals Corp ALLOPURINOL SODIUM 500 mg/25mL Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0143-9542_5444784f-fefe-4352-afd1-b4c487165f3a 0143-9542 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20120302 NDA NDA022276 West-Ward Pharmaceuticals Corp NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0143-9546_105b6182-e10a-48a1-8fcb-4ce2cda83d4e 0143-9546 HUMAN PRESCRIPTION DRUG Adriamycin Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19960501 ANDA ANDA064097 West-Ward Pharmaceuticals Corp DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0143-9547_105b6182-e10a-48a1-8fcb-4ce2cda83d4e 0143-9547 HUMAN PRESCRIPTION DRUG Adriamycin Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19960501 ANDA ANDA062975 West-Ward Pharmaceuticals Corp DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0143-9548_105b6182-e10a-48a1-8fcb-4ce2cda83d4e 0143-9548 HUMAN PRESCRIPTION DRUG Adriamycin Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19960501 ANDA ANDA062975 West-Ward Pharmaceuticals Corp DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0143-9549_105b6182-e10a-48a1-8fcb-4ce2cda83d4e 0143-9549 HUMAN PRESCRIPTION DRUG Adriamycin Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19960501 ANDA ANDA062975 West-Ward Pharmaceuticals Corp DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0143-9552_15605732-2e6d-401b-9e74-93a2eaf12b57 0143-9552 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000420 ANDA ANDA040335 West-Ward Pharmaceuticals Corp LEUCOVORIN CALCIUM 350 mg/17.5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0143-9553_15605732-2e6d-401b-9e74-93a2eaf12b57 0143-9553 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19950523 ANDA ANDA040056 West-Ward Pharmaceuticals Corp LEUCOVORIN CALCIUM 200 mg/20mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0143-9554_15605732-2e6d-401b-9e74-93a2eaf12b57 0143-9554 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19880328 ANDA ANDA089717 West-Ward Pharmaceuticals Corp LEUCOVORIN CALCIUM 100 mg/10mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0143-9555_15605732-2e6d-401b-9e74-93a2eaf12b57 0143-9555 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19870914 ANDA ANDA089384 West-Ward Pharmaceuticals Corp LEUCOVORIN CALCIUM 50 mg/5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0143-9558_c613458b-2a5a-42a1-85cf-8869cadeafff 0143-9558 HUMAN PRESCRIPTION DRUG Levoleucovorin Levoleucovorin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160707 ANDA ANDA206263 West-Ward Pharmaceuticals Corp LEVOLEUCOVORIN CALCIUM 50 mg/5mL N 20181231 0143-9559_a37614b4-68d2-4c36-a1f2-577b6bdfb8b6 0143-9559 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20161101 NDA NDA203049 West-Ward Pharmaceuticals Corp ARGATROBAN 50 mg/50mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 0143-9564_c576619c-726c-44d6-9e4d-ae6b5f7e8b8e 0143-9564 HUMAN PRESCRIPTION DRUG Phentolamine Mesylate Phentolamine Mesylate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19980515 ANDA ANDA040235 West-Ward Pharmaceuticals Corp PHENTOLAMINE MESYLATE 5 mg/mL Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0143-9565_5fb8bc30-f209-4ae2-9bc4-fdcb769c70bd 0143-9565 HUMAN PRESCRIPTION DRUG Thiotepa Thiotepa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVITARY; INTRAVENOUS; INTRAVESICAL 20010601 ANDA ANDA075547 West-Ward Pharmaceuticals Corp THIOTEPA 15 mg/1.5mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0143-9566_bac75efb-4308-4e4e-bbe6-8afe8b336817 0143-9566 HUMAN PRESCRIPTION DRUG Azathioprine Sodium Azathioprine Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19950501 ANDA ANDA074419 West-Ward Pharmaceuticals Corp AZATHIOPRINE SODIUM 100 mg/10mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 0143-9567_aad47b5b-633e-431a-86d8-ab5cb1b9bde7 0143-9567 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20040109 ANDA ANDA065048 West-Ward Pharmaceutical Corp CEFUROXIME SODIUM 1.5 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9568_aad47b5b-633e-431a-86d8-ab5cb1b9bde7 0143-9568 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20040109 ANDA ANDA065048 West-Ward Pharmaceutical Corp CEFUROXIME SODIUM 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9569_adbf6ce7-e785-427b-9733-754490d0079a 0143-9569 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20040109 ANDA ANDA065046 West-Ward Pharmaceutical Corp CEFUROXIME SODIUM 7.5 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9570_6406bcdb-2178-4260-ac0e-edb0f01949fa 0143-9570 HUMAN PRESCRIPTION DRUG Sodium Ferric Gluconate Complex in Sucrose Sodium Ferric Gluconate Complex in Sucrose INJECTION INTRAVENOUS 20110331 ANDA ANDA078215 West-Ward Pharmaceutical Corp SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0143-9574_65b7d0bb-61ed-4b9f-9ff3-479f62350a37 0143-9574 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION INTRAVENOUS 20150601 ANDA ANDA090981 West-Ward Pharmaceuticals Corp LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0143-9575_2fc7caef-9d32-4001-91e2-b69c6513177f 0143-9575 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 19720214 ANDA ANDA080407 West-Ward Pharmaceuticals Corp LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0143-9576_2fc7caef-9d32-4001-91e2-b69c6513177f 0143-9576 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 19720214 ANDA ANDA080407 West-Ward Pharmaceuticals Corp LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0143-9577_2fc7caef-9d32-4001-91e2-b69c6513177f 0143-9577 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 19720214 ANDA ANDA080407 West-Ward Pharmaceuticals Corp LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0143-9578_2fc7caef-9d32-4001-91e2-b69c6513177f 0143-9578 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 19720214 ANDA ANDA080407 West-Ward Pharmaceuticals Corp LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0143-9579_2fc7caef-9d32-4001-91e2-b69c6513177f 0143-9579 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 19720214 ANDA ANDA080407 West-Ward Pharmaceuticals Corp LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0143-9580_b301fcfc-fb14-46cc-ad49-56c5572c40ba 0143-9580 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 West-ward Pharmaceutical Corp SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0143-9581_b301fcfc-fb14-46cc-ad49-56c5572c40ba 0143-9581 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 West-ward Pharmaceutical Corp SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0143-9582_b301fcfc-fb14-46cc-ad49-56c5572c40ba 0143-9582 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 West-ward Pharmaceutical Corp SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0143-9583_1bf5ce64-ca8c-47c8-9e34-70d37817d67a 0143-9583 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20101220 ANDA ANDA091032 West-Ward Pharmaceuticals Corp IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0143-9584_c6d44207-2881-46a5-8976-ca5fa9481378 0143-9584 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20150601 ANDA ANDA090963 West-Ward Pharmaceutical Corp GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0143-9585_c6d44207-2881-46a5-8976-ca5fa9481378 0143-9585 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20150601 ANDA ANDA090963 West-Ward Pharmaceutical Corp GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0143-9586_c6d44207-2881-46a5-8976-ca5fa9481378 0143-9586 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20150601 ANDA ANDA090963 West-Ward Pharmaceutical Corp GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0143-9587_c6d44207-2881-46a5-8976-ca5fa9481378 0143-9587 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20150601 ANDA ANDA090963 West-Ward Pharmaceutical Corp GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0143-9593_8d52d397-936f-4cb8-80c3-f889344e137c 0143-9593 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20120302 NDA NDA022276 West-Ward Pharmaceuticals Corp NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0143-9594_42f92780-b30e-4e0f-afa8-d9a785c37b29 0143-9594 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19750616 ANDA ANDA084625 West-Ward Pharmaceuticals Corp LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0143-9595_42f92780-b30e-4e0f-afa8-d9a785c37b29 0143-9595 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19750616 ANDA ANDA084625 West-Ward Pharmaceuticals Corp LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0143-9596_9147dc37-4477-4654-ad36-be6488f73cce 0143-9596 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION INTRAVENOUS 20141118 NDA NDA205917 West-Ward Pharmaceutical Corp PARICALCITOL 5 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0143-9619_440f0907-5874-4d6c-b343-59b146beaaa8 0143-9619 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION INTRAMUSCULAR; SUBCUTANEOUS 19711020 ANDA ANDA080515 West-Ward Pharmaceuticals Corp CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 0143-9620_440f0907-5874-4d6c-b343-59b146beaaa8 0143-9620 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION INTRAMUSCULAR; SUBCUTANEOUS 19711020 ANDA ANDA080515 West-Ward Pharmaceuticals Corp CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 0143-9621_440f0907-5874-4d6c-b343-59b146beaaa8 0143-9621 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION INTRAMUSCULAR; SUBCUTANEOUS 19711020 ANDA ANDA080515 West-Ward Pharmaceuticals Corp CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20191231 0143-9622_e734eaa4-d3b8-4a2d-af36-4b8ba2643cb7 0143-9622 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION INTRAVENOUS 19991129 ANDA ANDA075303 West-Ward Pharmaceuticals Corp LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0143-9623_e734eaa4-d3b8-4a2d-af36-4b8ba2643cb7 0143-9623 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION INTRAVENOUS 19991129 ANDA ANDA075303 West-Ward Pharmaceuticals Corp LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0143-9624_9147dc37-4477-4654-ad36-be6488f73cce 0143-9624 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION INTRAVENOUS 20141118 NDA NDA205917 West-Ward Pharmaceutical Corp PARICALCITOL 5 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0143-9625_9147dc37-4477-4654-ad36-be6488f73cce 0143-9625 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION INTRAVENOUS 20141118 NDA NDA205917 West-Ward Pharmaceutical Corp PARICALCITOL 2 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0143-9637_4fbb88e4-2109-4414-ae01-a6d1578e872b 0143-9637 HUMAN PRESCRIPTION DRUG Valproate Sodium Valproate Sodium INJECTION INTRAVENOUS 20130415 ANDA ANDA078523 West-Ward Pharmaceuticals Corp VALPROATE SODIUM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 0143-9638_33088c98-033d-4a6a-8d63-405810ce5a47 0143-9638 HUMAN PRESCRIPTION DRUG SUMATRIPTAN sumatriptan INJECTION SUBCUTANEOUS 20130916 ANDA ANDA200183 West-Ward Pharmaceuticals Corp SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0143-9642_6090d2eb-02a1-45ff-8659-b30436b7f60c 0143-9642 HUMAN PRESCRIPTION DRUG Zoledronic Acid zoledronic acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130603 ANDA ANDA202182 West-Ward Pharmaceuticals Corp ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0143-9649_88edb668-e5cc-4bdc-8cb0-622ebed87063 0143-9649 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, FILM COATED ORAL 20141201 ANDA ANDA202859 West ward Pharmaceutical Corp MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 0143-9650_88edb668-e5cc-4bdc-8cb0-622ebed87063 0143-9650 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, CHEWABLE ORAL 20141201 ANDA ANDA203037 West ward Pharmaceutical Corp MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 0143-9651_88edb668-e5cc-4bdc-8cb0-622ebed87063 0143-9651 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, CHEWABLE ORAL 20141201 ANDA ANDA203037 West ward Pharmaceutical Corp MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 0143-9654_dc482e1f-d461-474e-96a4-ade47f9d3d1d 0143-9654 HUMAN PRESCRIPTION DRUG Sertraline sertraline hydrochloride TABLET, FILM COATED ORAL 20121106 ANDA ANDA077864 West-Ward Pharmaceutical Corp SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0143-9655_dc482e1f-d461-474e-96a4-ade47f9d3d1d 0143-9655 HUMAN PRESCRIPTION DRUG Sertraline sertraline hydrochloride TABLET, FILM COATED ORAL 20121106 ANDA ANDA077864 West-Ward Pharmaceutical Corp SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0143-9656_dc482e1f-d461-474e-96a4-ade47f9d3d1d 0143-9656 HUMAN PRESCRIPTION DRUG Sertraline sertraline hydrochloride TABLET, FILM COATED ORAL 20121106 ANDA ANDA077864 West-Ward Pharmaceutical Corp SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0143-9657_52309854-eabf-4aac-b3d9-f5c3cc6c3887 0143-9657 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160229 ANDA ANDA205771 West-Ward Pharmaceuticals Corp ACYCLOVIR SODIUM 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0143-9658_52309854-eabf-4aac-b3d9-f5c3cc6c3887 0143-9658 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160229 ANDA ANDA205771 West-Ward Pharmaceuticals Corp ACYCLOVIR SODIUM 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0143-9659_85839253-195f-43b2-aa3d-a777cc30af50 0143-9659 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION INTRAMUSCULAR 20120501 ANDA ANDA091244 West-Ward Pharmaceuticals Corp TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0143-9660_a74b47df-974c-41da-b156-d7dccaa62913 0143-9660 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoroprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20070530 ANDA ANDA077761 West-Ward Pharmaceuticals Corp METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0143-9665_7cd3e21a-2e0c-41cb-9d0f-2e846008bb20 0143-9665 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20041018 ANDA ANDA065143 West-Ward Pharmaceuticals Corp CEFAZOLIN SODIUM 20 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9666_5ff3469e-ad4d-4c74-8340-237226a77492 0143-9666 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20120130 ANDA ANDA078764 West-Ward Pharmaceutical Corp FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0143-9667_5ff3469e-ad4d-4c74-8340-237226a77492 0143-9667 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20120130 ANDA ANDA078764 West-Ward Pharmaceutical Corp FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0143-9668_5ff3469e-ad4d-4c74-8340-237226a77492 0143-9668 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20120130 ANDA ANDA078698 West-Ward Pharmaceutical Corp FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0143-9669_5ff3469e-ad4d-4c74-8340-237226a77492 0143-9669 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20120130 ANDA ANDA078698 West-Ward Pharmaceutical Corp FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0143-9670_931bef53-ed8a-493b-862d-1b7dce63d424 0143-9670 HUMAN PRESCRIPTION DRUG Cefotetan Cefotetan INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170917 ANDA ANDA091031 West-Ward Pharmaceuticals Corp CEFOTETAN 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9671_931bef53-ed8a-493b-862d-1b7dce63d424 0143-9671 HUMAN PRESCRIPTION DRUG Cefotetan Cefotetan INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170917 ANDA ANDA091031 West-Ward Pharmaceuticals Corp CEFOTETAN 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9673_0f8b8883-bff9-4503-a672-6dcf80e03f0b 0143-9673 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION INTRAVENOUS 20111013 ANDA ANDA090981 West-Ward Pharmaceuticals Corp LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0143-9674_a37614b4-68d2-4c36-a1f2-577b6bdfb8b6 0143-9674 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20120105 NDA NDA203049 West-Ward Pharmaceuticals Corp ARGATROBAN 250 mg/2.5mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 0143-9679_e7ccc4ea-215d-4a99-8583-1a3198aecd5b 0143-9679 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110921 ANDA ANDA090963 West-Ward Pharmaceutical Corp GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0143-9680_e7ccc4ea-215d-4a99-8583-1a3198aecd5b 0143-9680 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110921 ANDA ANDA090963 West-Ward Pharmaceutical Corp GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0143-9681_e7ccc4ea-215d-4a99-8583-1a3198aecd5b 0143-9681 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110921 ANDA ANDA090963 West-Ward Pharmaceutical Corp GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0143-9682_e7ccc4ea-215d-4a99-8583-1a3198aecd5b 0143-9682 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110921 ANDA ANDA090963 West-Ward Pharmaceutical Corp GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0143-9683_55c7aded-d21a-4257-9daa-de4aaf4f95a6 0143-9683 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION, SOLUTION INTRAVENOUS 20090323 ANDA ANDA078527 West-Ward Pharmaceutical Corp FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 0143-9684_55c7aded-d21a-4257-9daa-de4aaf4f95a6 0143-9684 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION, SOLUTION INTRAVENOUS 20090323 ANDA ANDA078527 West-Ward Pharmaceutical Corp FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 0143-9689_849af032-d4d5-492f-85f9-d2e5e6c7900a 0143-9689 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20120302 NDA NDA022276 West-Ward Pharmaceuticals Corp NICARDIPINE HYDROCHLORIDE 25 mg/10mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0143-9700_880e3f4e-70a6-403d-8cfd-c2bd97073a83 0143-9700 HUMAN PRESCRIPTION DRUG Cortisone Acetate Cortisone Acetate TABLET ORAL 20130822 ANDA ANDA080776 West-Ward Pharmaceuticals Corp CORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0143-9701_89546409-bce3-4e91-a92a-5b5a9de91483 0143-9701 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20101220 ANDA ANDA091032 West-Ward Pharmaceutical Corp IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0143-9702_89546409-bce3-4e91-a92a-5b5a9de91483 0143-9702 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20101220 ANDA ANDA091032 West-Ward Pharmaceutical Corp IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0143-9707_af7ceba6-da35-41f9-8207-5cfb1b4cea25 0143-9707 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20100816 ANDA ANDA078599 West-ward Pharmaceutical Corp GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 0143-9708_f160bf47-1821-4ec0-b552-b16ee670b609 0143-9708 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION, SOLUTION INTRAVENOUS 20101203 ANDA ANDA077966 West-ward Pharmaceutical Corp MILRINONE LACTATE 50 mg/50mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0143-9709_f160bf47-1821-4ec0-b552-b16ee670b609 0143-9709 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION, SOLUTION INTRAVENOUS 20101203 ANDA ANDA077966 West-ward Pharmaceutical Corp MILRINONE LACTATE 20 mg/20mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0143-9710_f160bf47-1821-4ec0-b552-b16ee670b609 0143-9710 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION, SOLUTION INTRAVENOUS 20101203 ANDA ANDA077966 West-ward Pharmaceutical Corp MILRINONE LACTATE 10 mg/10mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0143-9713_cee2c778-5cf9-4042-bb0b-10176096a8be 0143-9713 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130213 ANDA ANDA076063 West-Ward Pharmaceuticals Corp LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0143-9714_cee2c778-5cf9-4042-bb0b-10176096a8be 0143-9714 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130213 ANDA ANDA076063 West-Ward Pharmaceuticals Corp LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0143-9715_cee2c778-5cf9-4042-bb0b-10176096a8be 0143-9715 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130213 ANDA ANDA076063 West-Ward Pharmaceuticals Corp LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0143-9717_ed44dc8e-76f2-435e-b6c1-1c57c36babf6 0143-9717 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20090609 ANDA ANDA090035 West-ward Pharmaceutical Corp FOLIC ACID 1 mg/1 N 20181231 0143-9718_55124bda-bc13-47d2-a54d-ea7e5b72f6e5 0143-9718 HUMAN PRESCRIPTION DRUG Milrinone Lactate in Dextrose Milrinone Lactate in Dextrose INJECTION, SOLUTION INTRAVENOUS 20100121 ANDA ANDA090038 West-Ward Pharmaceuticals Corp MILRINONE LACTATE 200 ug/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0143-9719_55124bda-bc13-47d2-a54d-ea7e5b72f6e5 0143-9719 HUMAN PRESCRIPTION DRUG Milrinone Lactate in Dextrose Milrinone Lactate in Dextrose INJECTION, SOLUTION INTRAVENOUS 20100121 ANDA ANDA090038 West-Ward Pharmaceuticals Corp MILRINONE LACTATE 200 ug/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0143-9720_9f1c999a-5bc9-4ffc-b5eb-4a9ae42becf0 0143-9720 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110916 ANDA ANDA091375 West-Ward Pharmaceuticals Corp LEVOFLOXACIN 750 mg/150mL N 20181231 0143-9721_9f1c999a-5bc9-4ffc-b5eb-4a9ae42becf0 0143-9721 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110916 ANDA ANDA091375 West-Ward Pharmaceuticals Corp LEVOFLOXACIN 500 mg/100mL N 20181231 0143-9722_9f1c999a-5bc9-4ffc-b5eb-4a9ae42becf0 0143-9722 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110916 ANDA ANDA091375 West-Ward Pharmaceuticals Corp LEVOFLOXACIN 250 mg/50mL N 20181231 0143-9723_00d89444-a57a-42f0-b392-f44701802be1 0143-9723 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20110101 ANDA ANDA200300 West-ward Pharmaceutical Corp CLONIDINE HYDROCHLORIDE 500 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0143-9724_00d89444-a57a-42f0-b392-f44701802be1 0143-9724 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20110101 ANDA ANDA200300 West-ward Pharmaceutical Corp CLONIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0143-9725_5e444913-7afc-42d3-abf2-6c5dd2d51d7d 0143-9725 HUMAN PRESCRIPTION DRUG Progesterone Progesterone INJECTION INTRAMUSCULAR 20101028 ANDA ANDA091033 West-ward Pharmaceutical Corp PROGESTERONE 50 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 0143-9726_85839253-195f-43b2-aa3d-a777cc30af50 0143-9726 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION INTRAMUSCULAR 20120501 ANDA ANDA091244 West-Ward Pharmaceuticals Corp TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0143-9728_e3d84b78-e69d-4898-811c-c00ad67ea830 0143-9728 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol INJECTION INTRAVENOUS 20060208 ANDA ANDA077102 West-ward Pharmaceutical Corp CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 0143-9729_b2f18b99-f374-4d49-a556-babb60918a4f 0143-9729 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20090901 ANDA ANDA090287 West-Ward Pharmaceutical Corp BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0143-9738_bb7503ca-c32b-4d1a-b2b3-faba3176262a 0143-9738 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 West-Ward Pharmaceuticals Corp PREDNISONE 20 mg/1 N 20181231 0143-9739_bb7503ca-c32b-4d1a-b2b3-faba3176262a 0143-9739 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA088832 West-Ward Pharmaceuticals Corp PREDNISONE 10 mg/1 N 20181231 0143-9740_bb7503ca-c32b-4d1a-b2b3-faba3176262a 0143-9740 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA080292 West-Ward Pharmaceuticals Corp PREDNISONE 5 mg/1 N 20181231 0143-9742_7d661c28-a16f-4ff0-8447-8f8d60208d49 0143-9742 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION INTRAMUSCULAR; INTRAVENOUS 20130213 ANDA ANDA200219 West-Ward Pharmaceutical Corp OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] N 20181231 0143-9743_7d661c28-a16f-4ff0-8447-8f8d60208d49 0143-9743 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION INTRAMUSCULAR; INTRAVENOUS 20130213 ANDA ANDA200219 West-Ward Pharmaceutical Corp OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] N 20181231 0143-9744_3554c057-fdc1-4478-95dd-2ae743b2994b 0143-9744 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride INJECTION INTRAVENOUS 20091223 ANDA ANDA078629 West-Ward Pharmaceutical Corp GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0143-9745_3554c057-fdc1-4478-95dd-2ae743b2994b 0143-9745 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride INJECTION INTRAVENOUS 20091223 ANDA ANDA078629 West-Ward Pharmaceutical Corp GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0143-9746_bbabb8e2-a9e3-4615-8504-48801c87605f 0143-9746 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate INJECTION SUBCUTANEOUS 20090520 ANDA ANDA078630 West-ward Pharmaceutical Corp TERBUTALINE SULFATE 1 mg/mL N 20181231 0143-9747_3999cda9-e27c-46e9-9cf3-f9d00b62b296 0143-9747 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090247 West-ward Pharmaceutical Corp DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 0143-9748_3999cda9-e27c-46e9-9cf3-f9d00b62b296 0143-9748 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090247 West-ward Pharmaceutical Corp DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 0143-9749_91bd329a-9bbd-487a-a9c2-ec0a27d3d78c 0143-9749 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19960124 ANDA ANDA040124 West-ward Pharmaceutical Corp CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0143-9750_56ec032a-f3b6-49d5-abf6-18e086f14426 0143-9750 HUMAN PRESCRIPTION DRUG TESTOSTERONE ENANTHATE TESTOSTERONE ENANTHATE INJECTION, SOLUTION INTRAMUSCULAR 20120918 ANDA ANDA091120 West-Ward Pharmaceuticals Corp TESTOSTERONE ENANTHATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0143-9766_efb2fc5a-311f-4665-8942-e0a018428e02 0143-9766 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20121128 ANDA ANDA091036 West-Ward Pharmaceuticals Corp CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9767_efb2fc5a-311f-4665-8942-e0a018428e02 0143-9767 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20121128 ANDA ANDA091036 West-Ward Pharmaceuticals Corp CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9768_8c1c49da-f141-4040-8119-77980f1d10cd 0143-9768 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090806 ANDA ANDA065328 West-Ward Pharmaceutical Corp CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9769_bf7ebcb2-b720-4c58-8dde-a7f5e7eb2374 0143-9769 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin SUSPENSION ORAL 20090901 ANDA ANDA065444 West-ward Pharmaceutical Corp CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9770_bf7ebcb2-b720-4c58-8dde-a7f5e7eb2374 0143-9770 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin SUSPENSION ORAL 20090901 ANDA ANDA065444 West-ward Pharmaceutical Corp CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9771_b81ba160-bb0d-4d28-a191-20d2cd646bea 0143-9771 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride and Dextrose Ondansetron Hydrochloride and Dextrose INJECTION, SOLUTION INTRAVENOUS 20090804 ANDA ANDA078308 West-ward Pharmaceutical Corp ONDANSETRON HYDROCHLORIDE 32 mg/50mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 0143-9772_3f26593b-687f-47ba-8ad9-621d39c45b6b 0143-9772 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole INJECTION, SOLUTION INTRAVENOUS 20090804 ANDA ANDA078084 West-ward Pharmaceutical Corp METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 0143-9775_6ad21a7c-8e5b-4b61-8f11-d3cd921d8c12 0143-9775 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110621 ANDA ANDA078767 West-ward Pharmaceutical Corp LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 0143-9776_6ad21a7c-8e5b-4b61-8f11-d3cd921d8c12 0143-9776 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110621 ANDA ANDA078767 West-ward Pharmaceutical Corp LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 0143-9777_6ad21a7c-8e5b-4b61-8f11-d3cd921d8c12 0143-9777 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110621 ANDA ANDA078767 West-ward Pharmaceutical Corp LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 0143-9782_6b56fe59-9fb1-410b-b57c-7ada1662136a 0143-9782 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091202 ANDA ANDA078765 West-Ward Pharmaceuticals Corp FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20191231 0143-9783_3b882f0b-9d28-47f4-9ebb-11d2b40f5fb9 0143-9783 HUMAN PRESCRIPTION DRUG Flumazenil flumazenil INJECTION, SOLUTION INTRAVENOUS 20070101 ANDA ANDA078527 West-Ward Pharmaceuticals Corp FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 0143-9784_3b882f0b-9d28-47f4-9ebb-11d2b40f5fb9 0143-9784 HUMAN PRESCRIPTION DRUG Flumazenil flumazenil INJECTION, SOLUTION INTRAVENOUS 20070101 ANDA ANDA078527 West-Ward Pharmaceuticals Corp FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 0143-9785_044d9fa4-6b77-4ae5-a23f-e2c0a7bfe0e3 0143-9785 HUMAN PRESCRIPTION DRUG Valproate Sodium Valproate Sodium INJECTION INTRAVENOUS 20100217 ANDA ANDA078523 West-Ward Pharmaceuticals Corp VALPROATE SODIUM 500 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 0143-9786_81ce7020-cda4-43fa-bfa3-d642918c5aeb 0143-9786 HUMAN PRESCRIPTION DRUG Enalaprilat enalaprilat INJECTION INTRAVENOUS 20081223 ANDA ANDA078687 West-ward Pharmaceutical Corp ENALAPRILAT 2.5 mg/2mL N 20181231 0143-9787_81ce7020-cda4-43fa-bfa3-d642918c5aeb 0143-9787 HUMAN PRESCRIPTION DRUG Enalaprilat enalaprilat INJECTION INTRAVENOUS 20081223 ANDA ANDA078687 West-ward Pharmaceutical Corp ENALAPRILAT 1.25 mg/mL N 20181231 0143-9788_6b56fe59-9fb1-410b-b57c-7ada1662136a 0143-9788 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091202 ANDA ANDA078765 West-Ward Pharmaceuticals Corp FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20191231 0143-9803_95bf0954-c35b-4a16-a7a2-cbf6ce85fc3c 0143-9803 HUMAN PRESCRIPTION DRUG Doxycyclate Hyclate Doxycycline Hyclate CAPSULE ORAL 19900901 ANDA ANDA062396 West-Ward Pharmaceuticals Corp DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0143-9807_322655e3-fff3-4292-abf5-fb9634227072 0143-9807 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 West-Ward Pharmaceuticals Corp ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0143-9808_322655e3-fff3-4292-abf5-fb9634227072 0143-9808 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 West-Ward Pharmaceuticals Corp ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0143-9809_322655e3-fff3-4292-abf5-fb9634227072 0143-9809 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 West-Ward Pharmaceuticals Corp ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0143-9830_2ffd9da2-5eb2-430a-93df-0d2423335edb 0143-9830 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20050906 ANDA ANDA040632 West-Ward Pharmaceuticals Corp METHOTREXATE 1 g/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 0143-9836_3baa064d-3710-4059-bb4f-04aa1585f1fe 0143-9836 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20131011 ANDA ANDA090549 West-Ward Pharmaceuticals Corp PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0143-9837_3baa064d-3710-4059-bb4f-04aa1585f1fe 0143-9837 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20131011 ANDA ANDA090549 West-Ward Pharmaceuticals Corp PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0143-9853_f069c3c1-ff3b-4cc6-9d2c-9e75d208c91e 0143-9853 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20090803 ANDA ANDA065373 West-ward Pharmaceutical Corp AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0143-9856_33ffaa51-196f-4bb3-962f-3985b2484df0 0143-9856 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080110 ANDA ANDA065342 West-Ward Pharmaceuticals Corp CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9857_33ffaa51-196f-4bb3-962f-3985b2484df0 0143-9857 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080110 ANDA ANDA065342 West-Ward Pharmaceuticals Corp CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9858_33ffaa51-196f-4bb3-962f-3985b2484df0 0143-9858 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080110 ANDA ANDA065342 West-Ward Pharmaceuticals Corp CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9859_33ffaa51-196f-4bb3-962f-3985b2484df0 0143-9859 HUMAN PRESCRIPTION DRUG Ceftriaxone ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080110 ANDA ANDA065342 West-Ward Pharmaceuticals Corp CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9864_32c978ea-ba6e-4f67-9433-535397551236 0143-9864 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090501 ANDA ANDA078400 West-Ward Pharmaceuticals Corp BUTORPHANOL TARTRATE 1 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV N 20181231 0143-9867_32c978ea-ba6e-4f67-9433-535397551236 0143-9867 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090501 ANDA ANDA078400 West-Ward Pharmaceuticals Corp BUTORPHANOL TARTRATE 2 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV N 20181231 0143-9872_eeadb649-e3e6-464d-b0fc-6408aeb3044f 0143-9872 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride INJECTION INTRAVENOUS 20080131 ANDA ANDA077760 West-Ward Pharmaceutical Corp PROPRANOLOL HYDROCHLORIDE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0143-9873_a74b47df-974c-41da-b156-d7dccaa62913 0143-9873 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20070530 ANDA ANDA077761 West-Ward Pharmaceuticals Corp METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0143-9875_9a009ad9-cbd9-470f-889d-12847ba1d0ef 0143-9875 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20080225 ANDA ANDA077234 West-Ward Pharmaceuticals Corp AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0143-9876_b432696a-f12e-4fd8-8385-d77613bb8c72 0143-9876 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100226 ANDA ANDA065239 West-ward Pharmaceutical Corp CEFOXITIN SODIUM 1 g/10mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9877_c0e4d752-c41e-455a-96d4-cb1deb8bb3e5 0143-9877 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100312 ANDA ANDA065238 West-Ward Pharmaceuticals Corp CEFOXITIN SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9878_c0e4d752-c41e-455a-96d4-cb1deb8bb3e5 0143-9878 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100312 ANDA ANDA065238 West-Ward Pharmaceuticals Corp CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9886_d74f0bfa-836b-47a4-8f7d-3accec98e515 0143-9886 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 West-Ward Pharmaceuticals Corp AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0143-9887_d74f0bfa-836b-47a4-8f7d-3accec98e515 0143-9887 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 West-Ward Pharmaceuticals Corp AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0143-9888_d74f0bfa-836b-47a4-8f7d-3accec98e515 0143-9888 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 West-Ward Pharmaceuticals Corp AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0143-9889_d74f0bfa-836b-47a4-8f7d-3accec98e515 0143-9889 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 West-Ward Pharmaceuticals Corp AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0143-9890_2f794f6b-1ec6-494b-9480-c71ac15c6c56 0143-9890 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA076781 West-Ward Pharmaceuticals Corp ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0143-9891_2f794f6b-1ec6-494b-9480-c71ac15c6c56 0143-9891 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA076780 West-Ward Pharmaceuticals Corp ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0143-9897_b0eabaad-ce4d-45db-8c84-95191f9df009 0143-9897 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 West-ward Pharmaceutical Corp CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9898_b0eabaad-ce4d-45db-8c84-95191f9df009 0143-9898 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 West-ward Pharmaceutical Corp CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9899_5ff3469e-ad4d-4c74-8340-237226a77492 0143-9899 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20050823 ANDA ANDA076736 West-Ward Pharmaceutical Corp FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0143-9908_23f89437-006e-4487-b224-f48045dab0b5 0143-9908 HUMAN PRESCRIPTION DRUG NAPROXEN naproxen sodium TABLET, FILM COATED ORAL 19960514 ANDA ANDA074480 West-Ward Pharmaceutical Corp NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0143-9916_23f89437-006e-4487-b224-f48045dab0b5 0143-9916 HUMAN PRESCRIPTION DRUG NAPROXEN naproxen sodium TABLET, FILM COATED ORAL 19980218 ANDA ANDA074480 West-Ward Pharmaceutical Corp NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0143-9918_478b722b-1d58-415f-b7d4-fce3c0cf081a 0143-9918 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20030801 ANDA ANDA075890 West-Ward Pharmaceuticals Corp GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0143-9919_478b722b-1d58-415f-b7d4-fce3c0cf081a 0143-9919 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20030801 ANDA ANDA075890 West-Ward Pharmaceuticals Corp GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0143-9920_478b722b-1d58-415f-b7d4-fce3c0cf081a 0143-9920 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20030801 ANDA ANDA075890 West-Ward Pharmaceuticals Corp GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0143-9923_9fbee540-5690-4c86-aa1c-ca76203c6ba1 0143-9923 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010918 ANDA ANDA065047 West-Ward Pharmaceuticals Corp CEFAZOLIN SODIUM 225 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9924_9fbee540-5690-4c86-aa1c-ca76203c6ba1 0143-9924 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010918 ANDA ANDA065047 West-Ward Pharmaceuticals Corp CEFAZOLIN SODIUM 330 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9927_6acdf825-275b-4f5d-a20d-f36a11e286db 0143-9927 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 West-Ward Pharmaceuticals Corp CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0143-9928_6acdf825-275b-4f5d-a20d-f36a11e286db 0143-9928 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 West-Ward Pharmaceuticals Corp CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0143-9929_6acdf825-275b-4f5d-a20d-f36a11e286db 0143-9929 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 West-Ward Pharmaceuticals Corp CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0143-9930_3d7a0ba8-fd98-4cd5-9ca3-053c3cdf8df2 0143-9930 HUMAN PRESCRIPTION DRUG Cefotaxime Cefotaxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20021120 ANDA ANDA065072 West-Ward Pharmaceutical Corp CEFOTAXIME SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9931_3d7a0ba8-fd98-4cd5-9ca3-053c3cdf8df2 0143-9931 HUMAN PRESCRIPTION DRUG Cefotaxime Cefotaxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20021120 ANDA ANDA065072 West-Ward Pharmaceutical Corp CEFOTAXIME SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9933_3d7a0ba8-fd98-4cd5-9ca3-053c3cdf8df2 0143-9933 HUMAN PRESCRIPTION DRUG Cefotaxime Cefotaxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20021120 ANDA ANDA065072 West-Ward Pharmaceutical Corp CEFOTAXIME SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9935_6ce0c3b7-f66f-4615-885b-781776832394 0143-9935 HUMAN PRESCRIPTION DRUG Cefotaxime Cefotaxime INJECTION INTRAVENOUS 20021120 ANDA ANDA065071 West-Ward Pharmaceutical Corp CEFOTAXIME SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9938_e90707f9-ab2d-4154-854a-187eb7e12d47 0143-9938 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070301 ANDA ANDA065291 West-ward Pharmaceutical Corp AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0143-9939_e90707f9-ab2d-4154-854a-187eb7e12d47 0143-9939 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070301 ANDA ANDA065291 West-ward Pharmaceutical Corp AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0143-9947_754b76f2-8e97-41f5-baa2-431444901e4c 0143-9947 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20060207 ANDA ANDA065311 West-Ward Pharmaceuticals Corp CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9948_df80802f-b661-445f-ab63-bcbd61a795b1 0143-9948 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil TABLET, FILM COATED ORAL 20060330 ANDA ANDA065260 West-Ward Pharmaceutical Corp CEFADROXIL 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9951_e6d811af-6e3d-443c-819e-94283bd57f9b 0143-9951 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 West-Ward Pharmaceutical Corp AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0143-9959_8830c95c-2da3-46c9-8a3a-3221678584dc 0143-9959 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20110412 ANDA ANDA077771 West-Ward Pharmaceuticals Corp AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 0143-9960_8830c95c-2da3-46c9-8a3a-3221678584dc 0143-9960 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20110412 ANDA ANDA077771 West-Ward Pharmaceuticals Corp AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 0143-9961_8830c95c-2da3-46c9-8a3a-3221678584dc 0143-9961 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20110412 ANDA ANDA077771 West-Ward Pharmaceuticals Corp AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 0143-9962_44d3d32b-6e68-4915-920e-ede52ed92f26 0143-9962 HUMAN PRESCRIPTION DRUG Zolpidem Zolpidem Tartrate TABLET ORAL 20080430 ANDA ANDA078129 West-ward Pharmaceutical Corp ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 0143-9963_44d3d32b-6e68-4915-920e-ede52ed92f26 0143-9963 HUMAN PRESCRIPTION DRUG Zolpidem Zolpidem Tartrate TABLET ORAL 20080430 ANDA ANDA078129 West-ward Pharmaceutical Corp ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 0143-9964_f3575e3b-3675-4c55-a717-f78cfdc07005 0143-9964 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 West-ward Pharmaceutical Corp LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 0143-9965_f3575e3b-3675-4c55-a717-f78cfdc07005 0143-9965 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 West-ward Pharmaceutical Corp LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 0143-9966_f3575e3b-3675-4c55-a717-f78cfdc07005 0143-9966 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 West-ward Pharmaceutical Corp LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 0143-9967_f3575e3b-3675-4c55-a717-f78cfdc07005 0143-9967 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 West-ward Pharmaceutical Corp LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 0143-9968_2af0b72f-36cf-4bb8-848a-cfe9b33d2f71 0143-9968 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20120926 ANDA ANDA090543 West-Ward Pharmaceuticals Corp MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 0143-9969_2af0b72f-36cf-4bb8-848a-cfe9b33d2f71 0143-9969 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20120926 ANDA ANDA090543 West-Ward Pharmaceuticals Corp MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 0143-9976_a6f00222-2665-465e-9cd9-0ea5e7b03f32 0143-9976 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20040109 ANDA ANDA065046 West-Ward Pharmaceutical Corp CEFUROXIME SODIUM 750 mg/8mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9977_608166d8-dc0d-4ee6-9d7c-00023cca1d88 0143-9977 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20040109 ANDA ANDA065048 West-Ward Pharmaceutical Corp CEFUROXIME SODIUM 1.5 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9979_608166d8-dc0d-4ee6-9d7c-00023cca1d88 0143-9979 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20040109 ANDA ANDA065048 West-Ward Pharmaceutical Corp CEFUROXIME SODIUM 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9981_910853ad-d8cf-4b3c-8440-17ce438a799b 0143-9981 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 West-Ward Pharmaceutical Corp AMOXICILLIN; CLAVULANIC ACID 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0143-9982_910853ad-d8cf-4b3c-8440-17ce438a799b 0143-9982 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 West-Ward Pharmaceutical Corp AMOXICILLIN; CLAVULANIC ACID 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0143-9983_7cd3e21a-2e0c-41cb-9d0f-2e846008bb20 0143-9983 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20041018 ANDA ANDA065143 West-Ward Pharmaceuticals Corp CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9985_895b07e1-e575-413b-9742-6acc77e2e4e1 0143-9985 HUMAN PRESCRIPTION DRUG CEFACLOR CEFACLOR CAPSULE ORAL 20070501 ANDA ANDA065350 West-Ward Pharmaceuticals Corp CEFACLOR 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9986_895b07e1-e575-413b-9742-6acc77e2e4e1 0143-9986 HUMAN PRESCRIPTION DRUG CEFACLOR CEFACLOR CAPSULE ORAL 20070501 ANDA ANDA065350 West-Ward Pharmaceuticals Corp CEFACLOR 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0143-9992_02f23e78-3140-458b-9955-021229fb1d67 0143-9992 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 West-ward Pharmaceutical Corp GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 0143-9993_02f23e78-3140-458b-9955-021229fb1d67 0143-9993 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 West-ward Pharmaceutical Corp GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 0143-9994_02f23e78-3140-458b-9955-021229fb1d67 0143-9994 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 West-ward Pharmaceutical Corp GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 0145-0020_b14ce1fc-f9f3-4410-b6ee-58d5cf1a12d7 0145-0020 HUMAN PRESCRIPTION DRUG Fabior tazarotene AEROSOL, FOAM TOPICAL 20130904 20180930 NDA NDA202428 Stiefel Laboratories, Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0145-0090_2df321be-bc38-49b3-b485-fa9f6725aec0 0145-0090 HUMAN PRESCRIPTION DRUG SORIATANE acitretin CAPSULE ORAL 19961101 NDA NDA019821 Stiefel Laboratories Inc ACITRETIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0145-0091_2df321be-bc38-49b3-b485-fa9f6725aec0 0145-0091 HUMAN PRESCRIPTION DRUG SORIATANE acitretin CAPSULE ORAL 19961101 NDA NDA019821 Stiefel Laboratories Inc ACITRETIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0145-0628_d5a101cc-0b57-4d2e-833a-5768bec1791c 0145-0628 HUMAN OTC DRUG Sarna camphor and menthol LOTION TOPICAL 20110222 OTC MONOGRAPH NOT FINAL part348 Stiefel Laboratories, Inc CAMPHOR (NATURAL); MENTHOL .6; .6 mg/mL; mg/mL N 20181231 0145-0630_0b6cdeba-b3fe-4ce3-88b9-d98463f49b4b 0145-0630 HUMAN OTC DRUG Sarna pramoxine hydrochloride LOTION TOPICAL 20110222 OTC MONOGRAPH NOT FINAL part348 Stiefel Laboratories, Inc PRAMOXINE HYDROCHLORIDE 1 mg/mL N 20181231 0145-0983_6d0da292-5c24-4729-8585-42f1af147198 0145-0983 HUMAN OTC DRUG PanOxyl benzoyl peroxide SOAP TOPICAL 20101110 OTC MONOGRAPH FINAL part333D Stiefel Laboratories Inc BENZOYL PEROXIDE 1 g/10g N 20181231 0145-0985_52bfa911-93bb-492d-8e7f-2db7dc6d2196 0145-0985 HUMAN OTC DRUG PanOxyl benzoyl peroxide CREAM TOPICAL 20110325 OTC MONOGRAPH FINAL part333D Stiefel Laboratories Inc BENZOYL PEROXIDE 146.7 mg/g N 20181231 0145-1501_57005561-7550-4188-b51d-2386fb80386f 0145-1501 HUMAN OTC DRUG Zeasorb miconazole nitrate POWDER TOPICAL 20110314 OTC MONOGRAPH FINAL part333C Stiefel Laboratories Inc MICONAZOLE NITRATE 20.6 mg/g N 20181231 0145-1506_57005561-7550-4188-b51d-2386fb80386f 0145-1506 HUMAN OTC DRUG Zeasorb miconazole nitrate POWDER TOPICAL 20110314 OTC MONOGRAPH FINAL part333C Stiefel Laboratories Inc MICONAZOLE NITRATE 20.6 mg/g N 20181231 0145-2130_8469d93a-5a7a-4c39-8127-e822642f3f58 0145-2130 HUMAN PRESCRIPTION DRUG SORILUX calcipotriene AEROSOL, FOAM TOPICAL 20101026 20181031 NDA NDA022563 Stiefel Laboratories Inc CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 0145-2371_b9e096e3-da88-4c88-a1c1-d74fd4a0b81d 0145-2371 HUMAN PRESCRIPTION DRUG DUAC clindamycin phosphate and benzoyl peroxide GEL TOPICAL 20071022 NDA NDA050741 Stiefel Laboratories Inc CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE 10; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0145-2660_52bfa911-93bb-492d-8e7f-2db7dc6d2196 0145-2660 HUMAN OTC DRUG PanOxyl benzoyl peroxide CREAM TOPICAL 20110325 OTC MONOGRAPH FINAL part333D Stiefel Laboratories Inc BENZOYL PEROXIDE 58.7 mg/g N 20181231 0145-3817_2df321be-bc38-49b3-b485-fa9f6725aec0 0145-3817 HUMAN PRESCRIPTION DRUG SORIATANE acitretin CAPSULE ORAL 20100104 20180731 NDA NDA019821 Stiefel Laboratories Inc ACITRETIN 17.5 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0149-0470_05985725-417c-44f4-9e38-4fed7cdfdaad 0149-0470 HUMAN PRESCRIPTION DRUG ACTONEL RISEDRONATE SODIUM TABLET, FILM COATED ORAL 19980327 NDA NDA020835 Warner Chilcott Pharmaceuticals Inc. RISEDRONATE SODIUM 30 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0149-0471_05985725-417c-44f4-9e38-4fed7cdfdaad 0149-0471 HUMAN PRESCRIPTION DRUG ACTONEL RISEDRONATE SODIUM TABLET, FILM COATED ORAL 20000414 NDA NDA020835 Warner Chilcott Pharmaceuticals Inc. RISEDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0149-0472_05985725-417c-44f4-9e38-4fed7cdfdaad 0149-0472 HUMAN PRESCRIPTION DRUG ACTONEL RISEDRONATE SODIUM TABLET, FILM COATED ORAL 20020517 NDA NDA020835 Warner Chilcott Pharmaceuticals Inc. RISEDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0149-0478_05985725-417c-44f4-9e38-4fed7cdfdaad 0149-0478 HUMAN PRESCRIPTION DRUG ACTONEL RISEDRONATE SODIUM TABLET, FILM COATED ORAL 20080422 NDA NDA020835 Warner Chilcott Pharmaceuticals Inc. RISEDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0159-2200_5ae6fba5-3a62-6716-e053-2991aa0a5d09 0159-2200 HUMAN OTC DRUG Selan Plus Zinc Oxide Selan Plus Zinc Oxide CREAM TOPICAL 19970829 OTC MONOGRAPH FINAL part347 Trividia Manufacturing Solutions, Inc ZINC OXIDE; DIMETHICONE 2; 2.1 g/100g; 1/100g N 20181231 0159-2400_5ae6fba5-3a55-6716-e053-2991aa0a5d09 0159-2400 HUMAN OTC DRUG Selan Plus Zinc Selan Plus Zinc LOTION TOPICAL 19970829 OTC MONOGRAPH FINAL part347 Trividia Manufacturing Solutions, Inc DIMETHICONE; ZINC OXIDE 2.3; 2 g/100g; g/100g N 20181231 0159-2500_5c3d55e9-81ca-62f1-e053-2a91aa0a1368 0159-2500 HUMAN OTC DRUG Selan Antifungal Selan Antifungal CREAM TOPICAL 20031105 OTC MONOGRAPH FINAL part333C Trividia Manufacturing Solutions, Inc MICONAZOLE NITRATE 2 g/100g N 20181231 0164-2189_5f0f7acc-f134-43bb-9797-48e73a35e64f 0164-2189 HUMAN OTC DRUG CALENDULA DIAPER RASH CREAM ZINC OXIDE CREAM TOPICAL 20130627 OTC MONOGRAPH FINAL part347 Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled ZINC OXIDE 12 g/100g E 20171231 0164-2207_436b3d70-1250-4ad2-a8d9-ead21ada6ec2 0164-2207 HUMAN OTC DRUG WHITE MALLOW DIAPER RASH CREAM ZINC OXIDE CREAM TOPICAL 20140822 OTC MONOGRAPH FINAL part347 Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled ZINC OXIDE 14 g/100g E 20171231 0168-0002_f6f59abc-d9aa-4d25-a6ba-47b51f38d0be 0168-0002 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0003_f6f59abc-d9aa-4d25-a6ba-47b51f38d0be 0168-0003 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0004_f6f59abc-d9aa-4d25-a6ba-47b51f38d0be 0168-0004 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0005_5016b192-7138-406c-9e23-f17532096db8 0168-0005 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT TOPICAL 19780214 ANDA ANDA085691 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0006_5016b192-7138-406c-9e23-f17532096db8 0168-0006 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT TOPICAL 19780214 ANDA ANDA085691 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0007_22c7e939-c21c-44ea-a25a-21799f910b6a 0168-0007 HUMAN PRESCRIPTION DRUG Nystatin nystatin OINTMENT TOPICAL 19820923 ANDA ANDA062124 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0168-0011_344e6723-0baa-46dc-9402-0cda653b9b94 0168-0011 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20100108 OTC MONOGRAPH FINAL part333B E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. BACITRACIN ZINC 500 [USP'U]/g N 20181231 0168-0012_17785628-26c0-4498-aba8-c121fafb36d4 0168-0012 HUMAN OTC DRUG Triple Antibiotic Neomycin and Polymyxin B Sulfates and Bacitracin Zinc OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 0168-0014_c93b88e1-c15b-42ba-a8fb-7bbc37cdc0bb 0168-0014 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 19680101 OTC MONOGRAPH FINAL part348 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 5 mg/g N 20181231 0168-0015_5db5853e-d002-4127-893c-09912624a729 0168-0015 HUMAN PRESCRIPTION DRUG hydrocortisone Hydrocortisone CREAM TOPICAL 19760430 ANDA ANDA080693 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0016_293ecf1f-6b74-4484-a61f-57e5421c1729 0168-0016 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE OINTMENT TOPICAL 19810101 OTC MONOGRAPH FINAL part348 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 5 mg/g N 20181231 0168-0020_692473d8-a4a7-464c-b45f-76f0a0d92ae3 0168-0020 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19750416 ANDA ANDA080692 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0021_443a7f87-7fdc-4c44-aad9-f7d8441e7f2a 0168-0021 HUMAN OTC DRUG Double Antibiotic Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 0168-0033_db3e31a3-44a5-49a7-9a2f-e2df8ccd13a4 0168-0033 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate OINTMENT TOPICAL 19830831 NDA NDA018865 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0035_3378f795-df7c-4de8-96dd-99afa2f5d4b6 0168-0035 HUMAN OTC DRUG Vitamin A and Vitamin D Vitamin A and Vitamin D OINTMENT TOPICAL 19810101 OTC MONOGRAPH FINAL part347 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. PETROLATUM 929.3 mg/g N 20181231 0168-0037_cbc1646c-2fe3-4140-a73c-aaee7c9013c6 0168-0037 HUMAN PRESCRIPTION DRUG nystatin nystatin SUSPENSION ORAL 19840607 ANDA ANDA062517 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0168-0040_db3e31a3-44a5-49a7-9a2f-e2df8ccd13a4 0168-0040 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate CREAM TOPICAL 19830831 NDA NDA018861 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0041_db3e31a3-44a5-49a7-9a2f-e2df8ccd13a4 0168-0041 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate LOTION TOPICAL 19830831 NDA NDA018866 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE VALERATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0046_cc66c053-6c73-4d9b-979b-f508f7c0aa5c 0168-0046 HUMAN OTC DRUG DIBUCAINE DIBUCAINE OINTMENT TOPICAL 19680101 OTC MONOGRAPH FINAL part346 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DIBUCAINE 1 g/100g N 20181231 0168-0053_02ef00c3-1c1d-43f9-977c-3f36133b8f30 0168-0053 HUMAN OTC DRUG White Petrolatum White Petrolatum OINTMENT TOPICAL 19680101 OTC MONOGRAPH FINAL part347 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. PETROLATUM 1 g/g N 20181231 0168-0054_3d5e563c-5fb7-451c-ba85-2671f67781fb 0168-0054 HUMAN PRESCRIPTION DRUG nystatin nystatin CREAM TOPICAL 19790201 ANDA ANDA062129 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0168-0055_c3d10d7e-bddc-4c3c-b8c7-daf578ccf3d5 0168-0055 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19840626 NDA NDA019137 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0056_c3d10d7e-bddc-4c3c-b8c7-daf578ccf3d5 0168-0056 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 19840904 NDA NDA019141 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0057_c3d10d7e-bddc-4c3c-b8c7-daf578ccf3d5 0168-0057 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate LOTION TOPICAL 19850812 ANDA ANDA070275 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0058_7b967ebe-35b7-4480-bbc4-7d3c87ba5358 0168-0058 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide CREAM TOPICAL 19821216 ANDA ANDA088170 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINOLONE ACETONIDE .1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0059_7a5aa210-3f89-4be6-bc63-d406f89f8017 0168-0059 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide SOLUTION TOPICAL 19821216 ANDA ANDA088167 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0168-0060_7b967ebe-35b7-4480-bbc4-7d3c87ba5358 0168-0060 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide CREAM TOPICAL 19821216 ANDA ANDA088169 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0062_9b514216-a692-4785-ae86-1b8f92e67e07 0168-0062 HUMAN OTC DRUG ZINC OXIDE ZINC OXIDE OINTMENT TOPICAL 19680101 OTC MONOGRAPH FINAL part347 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ZINC OXIDE 200 mg/g N 20181231 0168-0064_9e6ded3b-f4d1-48dd-9cec-939ed9704aa9 0168-0064 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide OINTMENT TOPICAL 19821216 ANDA ANDA088168 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0071_d9702c76-5f4e-4a76-b3a4-e7635f39d504 0168-0071 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate gentamicin sulfate CREAM TOPICAL 19840705 ANDA ANDA062531 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0168-0078_c6dd33a2-904b-4015-8477-5018db198fdc 0168-0078 HUMAN PRESCRIPTION DRUG Gentamicin sulfate Gentamicin Sulfate OINTMENT TOPICAL 20100317 ANDA ANDA062533 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. GENTAMICIN 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0168-0080_e5117883-9abd-4c68-9c4e-c85966c6db76 0168-0080 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19861216 ANDA ANDA089414 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0081_615fe7b2-2f00-4757-a86a-886d7f19f099 0168-0081 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide nystatin and triamcinolone acetonide CREAM TOPICAL 19851008 ANDA ANDA062599 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0089_4b0b2154-1180-41e9-a8da-5f112e38be72 0168-0089 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide nystatin and triamcinolone acetonide OINTMENT TOPICAL 19851009 ANDA ANDA062602 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0099_e8730b30-2be1-46ad-ac18-52a9b25200a5 0168-0099 HUMAN PRESCRIPTION DRUG ketoconazole ketoconazole CREAM TOPICAL 20040428 ANDA ANDA076294 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0168-0111_344e6723-0baa-46dc-9402-0cda653b9b94 0168-0111 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20100108 OTC MONOGRAPH FINAL part333B E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. BACITRACIN ZINC 500 [USP'U]/g N 20181231 0168-0126_62aa773d-b562-488f-a5a3-bc42c64ecf6f 0168-0126 HUMAN OTC DRUG Swim-EAR Swim-EAR SOLUTION AURICULAR (OTIC) 19700403 OTC MONOGRAPH FINAL part344 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ISOPROPYL ALCOHOL 950 mg/mL N 20181231 0168-0133_fbd28591-a9e7-417e-803a-5639b477c542 0168-0133 HUMAN PRESCRIPTION DRUG Clotrimazole clotrimazole CREAM TOPICAL 20080902 ANDA ANDA078338 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. CLOTRIMAZOLE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0168-0134_aa842484-50fb-44dc-b85f-b4a1191f571e 0168-0134 HUMAN PRESCRIPTION DRUG fluocinonide fluocinonide SOLUTION TOPICAL 19950227 ANDA ANDA072934 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0135_6579b94e-0705-45c7-8690-616806be922d 0168-0135 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide GEL TOPICAL 19941230 ANDA ANDA072933 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0139_b8565270-77a1-443d-bb34-eb36487e49eb 0168-0139 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide CREAM TOPICAL 19941017 ANDA ANDA073030 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0140_535364f5-60b2-4afb-a8dd-c98f4d5a1dbf 0168-0140 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide OINTMENT TOPICAL 19970826 ANDA ANDA074905 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0146_e5117883-9abd-4c68-9c4e-c85966c6db76 0168-0146 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19930528 ANDA ANDA081203 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0151_88597cd8-9757-4785-9401-5cf87468e411 0168-0151 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20120928 ANDA ANDA078657 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0154_c2104699-2e63-42f9-a39a-b9de1b6c7579 0168-0154 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 19760430 OTC MONOGRAPH NOT FINAL part348 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 10 mg/g N 20181231 0168-0162_4d279079-4a02-47e3-a641-ac9fe5e26ce0 0168-0162 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate OINTMENT TOPICAL 19960223 ANDA ANDA074407 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0163_4d279079-4a02-47e3-a641-ac9fe5e26ce0 0168-0163 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate CREAM TOPICAL 19960930 ANDA ANDA074392 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0180_d09d230b-d6f3-4576-8d08-36da381e06cf 0168-0180 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 20100629 ANDA ANDA078369 E. Fougera & Co., a division of Fougera Pharmaceuticals Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0181_f565cca1-8ab2-4a59-b137-41388b9d7627 0168-0181 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE OINTMENT TOPICAL 19750406 OTC MONOGRAPH NOT FINAL part348 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 10 mg/g N 20181231 0168-0201_2ceef9c9-088c-4104-adf1-1874ba2a23aa 0168-0201 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate SOLUTION TOPICAL 19970605 ANDA ANDA064159 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0168-0202_2ceef9c9-088c-4104-adf1-1874ba2a23aa 0168-0202 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate GEL TOPICAL 20000128 ANDA ANDA064160 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0168-0203_2ceef9c9-088c-4104-adf1-1874ba2a23aa 0168-0203 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate LOTION TOPICAL 20020131 ANDA ANDA065067 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0168-0204_3daec207-458a-41ff-b014-340ad58b8cae 0168-0204 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 19720630 ANDA ANDA080198 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0168-0215_1f7cee4e-f407-4f4d-84ef-12bb2bbe7f4a 0168-0215 HUMAN PRESCRIPTION DRUG Erythromycin erythromycin SOLUTION TOPICAL 19970930 ANDA ANDA064187 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ERYTHROMYCIN 20 mg/mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0168-0216_77dc5dfd-ef84-45cb-a0f5-61f382d213c9 0168-0216 HUMAN PRESCRIPTION DRUG Erythromycin erythromycin GEL TOPICAL 19970930 ANDA ANDA064184 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ERYTHROMYCIN 20 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0168-0242_619c5e2e-9e32-4a4d-b36b-31e480a5be3d 0168-0242 HUMAN PRESCRIPTION DRUG Diflorasone Diacetate diflorasone diacetate CREAM TOPICAL 19980330 ANDA ANDA075187 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0243_961ec6d3-69a9-42c8-b0bf-62be0fd55a18 0168-0243 HUMAN PRESCRIPTION DRUG Diflorasone Diacetate Diflorasone Diacetate OINTMENT TOPICAL 19990427 ANDA ANDA075374 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0246_6f553d79-de8b-4624-b271-d508bff0abf1 0168-0246 HUMAN PRESCRIPTION DRUG fluocinonide fluocinonide CREAM TOPICAL 20040623 ANDA ANDA076586 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0258_bbda5cdd-1685-410c-a419-d0d724ef3634 0168-0258 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20010605 ANDA ANDA075502 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0263_69a6ebd4-3ce4-4195-8564-0f1835270bf7 0168-0263 HUMAN PRESCRIPTION DRUG Alclometasone Dipropionate alclometasone dipropionate CREAM TOPICAL 20050712 ANDA ANDA076973 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0264_729b0089-46e0-44e0-bf30-f0fcbd3b3af0 0168-0264 HUMAN PRESCRIPTION DRUG Alclometasone Dipropionate alclometasone dipropionate OINTMENT TOPICAL 20050718 ANDA ANDA076884 E. Fougera & Co., a division of Fougera Pharmaceuticals Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0265_9d979fa0-8d65-45b4-a62a-d32d3662a0e7 0168-0265 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone dipropionate CREAM, AUGMENTED TOPICAL 20031209 ANDA ANDA076215 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0168-0266_70a6cd27-7b38-4928-8a8b-eb334960ef5e 0168-0266 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate GEL TOPICAL 20030513 ANDA ANDA075276 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0267_5651f5da-5cdf-4ae3-af18-50614bd1730e 0168-0267 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate LOTION, AUGMENTED TOPICAL 20070521 ANDA ANDA077111 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0268_ca7c847c-f15d-4225-9e85-f1079f7bbc23 0168-0268 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate betamethasone dipropionate OINTMENT, AUGMENTED TOPICAL 19990622 ANDA ANDA075373 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0269_a6dc8999-160d-4e2e-bda5-54df8bc52b3d 0168-0269 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SOLUTION TOPICAL 19990208 ANDA ANDA075391 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0270_dfd72204-6178-4814-a836-c39440714014 0168-0270 HUMAN PRESCRIPTION DRUG Mometasone Furoate mometasone furoate CREAM TOPICAL 20050408 ANDA ANDA076171 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0271_2a49444b-99c6-445a-887b-8c21e5c05e9f 0168-0271 HUMAN PRESCRIPTION DRUG Mometasone Furoate mometasone furoate OINTMENT TOPICAL 20050328 ANDA ANDA077061 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0272_cbb059dd-04f6-4485-b502-89bffb34f17c 0168-0272 HUMAN PRESCRIPTION DRUG Mometasone Furoate mometasone furoate SOLUTION TOPICAL 20071129 ANDA ANDA075919 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0168-0273_e16cc886-1989-4220-85ae-6b0cc2e3dee4 0168-0273 HUMAN PRESCRIPTION DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 20080828 ANDA ANDA065022 E. FOUGERA & CO., A division of Nycomed US Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 1/g; 1/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 0168-0275_d27e5e47-a839-4c14-a87a-e9ece251da00 0168-0275 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20060606 ANDA ANDA077018 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0168-0277_9a00a523-2d37-4abf-9cc3-fc58d5066ae5 0168-0277 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate clindamycin phosphate CREAM VAGINAL 20041227 ANDA ANDA065139 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0168-0278_5eaae9df-92e8-4c26-890d-54dead7e0ccb 0168-0278 HUMAN PRESCRIPTION DRUG Amcinonide Amcinonide CREAM TOPICAL 20030515 ANDA ANDA076065 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. AMCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0279_dda607c9-29ec-40bd-a925-cb74036f4790 0168-0279 HUMAN PRESCRIPTION DRUG Amcinonide amcinonide OINTMENT TOPICAL 20140403 ANDA ANDA076096 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. AMCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0280_eec28551-ddb9-4802-b634-6823d94fc5a7 0168-0280 HUMAN PRESCRIPTION DRUG amcinonide amcinonide LOTION TOPICAL 20021106 ANDA ANDA076329 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. AMCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0288_476ab49c-1073-40b1-8cd7-472ab8242f3c 0168-0288 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone LOTION TOPICAL 20000725 ANDA ANDA040351 E.FOUGERA & COMPANY A division of Fougera Pharmaceuticals Inc. HYDROCORTISONE 25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0293_4d279079-4a02-47e3-a641-ac9fe5e26ce0 0168-0293 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate GEL TOPICAL 20000215 ANDA ANDA075368 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0301_82bd8ab9-e23d-4212-8c96-e1f0896ee09b 0168-0301 HUMAN PRESCRIPTION DRUG Clobetasol Propionate (emollient) clobetasol propionate CREAM TOPICAL 19990526 ANDA ANDA075430 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0309_d40a3dee-8b60-4cd1-8815-d9c5aae9c763 0168-0309 HUMAN PRESCRIPTION DRUG desonide desonide OINTMENT TOPICAL 20010312 ANDA ANDA075751 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0310_a4ce1059-40da-4cde-a8d2-dc2a1762913e 0168-0310 HUMAN PRESCRIPTION DRUG desonide desonide LOTION TOPICAL 20020319 ANDA ANDA075860 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DESONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0312_ff081c1e-c154-4c1a-b138-e01f21127b44 0168-0312 HUMAN PRESCRIPTION DRUG Econazole Nitrate econazole nitrate CREAM TOPICAL 20021126 ANDA ANDA076075 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0168-0313_2c9efbd4-8a94-4331-b8b3-271d3036e2ff 0168-0313 HUMAN PRESCRIPTION DRUG ciclopirox olamine ciclopirox olamine CREAM TOPICAL 20041229 ANDA ANDA076435 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 0168-0314_ae069f7e-d070-401d-8d1b-3e835d9f48c8 0168-0314 HUMAN PRESCRIPTION DRUG Ciclopirox ciclopirox LOTION TOPICAL 20040806 ANDA ANDA076422 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CICLOPIROX OLAMINE 7.7 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 0168-0323_7991e21a-78a9-4853-9b25-70b7f684fe86 0168-0323 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole CREAM TOPICAL 20040528 ANDA ANDA076408 E.FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0168-0326_c0c4328d-68fc-4fea-87aa-93b385f3e7a9 0168-0326 HUMAN PRESCRIPTION DRUG NITRO-BID Nitroglycerin OINTMENT TOPICAL 20090815 ANDA ANDA087355 E. FOUGERA & CO., A division of Nycomed US Inc. NITROGLYCERIN 20 mg/g Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0168-0332_3d6ba8ce-10be-408a-b108-119aec02046f 0168-0332 HUMAN PRESCRIPTION DRUG FLUTICASONE PROPIONATE fluticasone propionate CREAM TOPICAL 20040514 ANDA ANDA076451 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0333_7bc876cd-707f-4206-a612-c04b370b41c5 0168-0333 HUMAN PRESCRIPTION DRUG Fluticasone Propionate fluticasone propionate OINTMENT TOPICAL 20040514 ANDA ANDA076300 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUTICASONE PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0336_1acd7149-8581-42b2-910d-a8b4cdf75020 0168-0336 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide LOTION TOPICAL 20030421 ANDA ANDA040467 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE .25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0337_1acd7149-8581-42b2-910d-a8b4cdf75020 0168-0337 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide LOTION TOPICAL 20030421 ANDA ANDA040467 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0346_16e72753-100e-4669-948e-0651291b6673 0168-0346 HUMAN PRESCRIPTION DRUG Terconazole terconazole CREAM VAGINAL 20050218 ANDA ANDA076712 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0168-0347_c0111708-86f4-4ba0-bbe3-aad538c9c313 0168-0347 HUMAN PRESCRIPTION DRUG Terconazole Vaginal Cream 0.8% terconazole CREAM VAGINAL 20041001 NDA NDA021735 E. FOUGERA & CO. A division of Nycomed US Inc. TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0168-0352_6189b9b1-72af-46c5-b82e-755c7803ad46 0168-0352 HUMAN PRESCRIPTION DRUG Mupirocin mupirocin OINTMENT TOPICAL 20051130 ANDA ANDA065192 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 0168-0353_dfdac9b3-4b7e-499d-9ce6-c27aaf278475 0168-0353 HUMAN PRESCRIPTION DRUG Diflorasone Diacetate diflorasone diacetate CREAM TOPICAL 20021220 ANDA ANDA076263 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0355_e34aaf90-e2e1-4f14-9ca9-7de9cd01ad86 0168-0355 HUMAN PRESCRIPTION DRUG Halobetasol Propionate halobetasol propionate CREAM TOPICAL 20041216 ANDA ANDA077001 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0356_db5eba0e-781c-4383-ab1f-15c025cf4290 0168-0356 HUMAN PRESCRIPTION DRUG Halobetasol Propionate halobetasol propionate OINTMENT TOPICAL 20041216 ANDA ANDA076903 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0357_aa36af91-58b5-4250-b470-dfbeaaa8a0e5 0168-0357 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine lidocaine and prilocaine CREAM TOPICAL 20030818 ANDA ANDA076453 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0168-0358_aa368d2b-a5d2-49dd-86e1-5693b68b46f4 0168-0358 HUMAN PRESCRIPTION DRUG Oxiconazole Nitrate Oxiconazole Nitrate CREAM TOPICAL 20160309 NDA AUTHORIZED GENERIC NDA019828 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. OXICONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0168-0370_9959fe30-5f39-44ca-ad36-907fcc204ced 0168-0370 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate LOTION TOPICAL 20050616 ANDA ANDA076516 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/mL; mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0381_82071531-988c-479b-8128-b482409ca90d 0168-0381 HUMAN PRESCRIPTION DRUG Prednicarbate prednicarbate CREAM TOPICAL 20060919 ANDA ANDA077287 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. PREDNICARBATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0382_25de4401-a67c-4a55-ae83-68a260a9e722 0168-0382 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SUSPENSION TOPICAL 20061117 ANDA ANDA077015 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0168-0383_c2698cac-0f0f-463e-89b1-1b661e5523d0 0168-0383 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole LOTION TOPICAL 20060524 ANDA ANDA077197 E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. METRONIDAZOLE 7.5 mg/mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0168-0400_63460907-b494-485c-a557-ec3b472e3e68 0168-0400 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene SOLUTION TOPICAL 20080506 ANDA ANDA078305 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CALCIPOTRIENE .05 mg/mL Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 0168-0407_0c2acee6-0de3-4a80-9483-c45c8506e504 0168-0407 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox GEL TOPICAL 20080610 ANDA ANDA077896 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CICLOPIROX 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 0168-0410_9012275c-1ce6-4acb-9889-f652df4f4ad9 0168-0410 HUMAN PRESCRIPTION DRUG Prednicarbate prednicarbate OINTMENT TOPICAL 20070309 ANDA ANDA077236 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. PREDNICARBATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0416_edc61947-bb3c-477e-b697-20993c8c642a 0168-0416 HUMAN PRESCRIPTION DRUG Tacrolimus tacrolimus OINTMENT TOPICAL 20140909 ANDA ANDA200744 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TACROLIMUS 1 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0168-0417_edc61947-bb3c-477e-b697-20993c8c642a 0168-0417 HUMAN PRESCRIPTION DRUG Tacrolimus tacrolimus OINTMENT TOPICAL 20140909 ANDA ANDA200744 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. TACROLIMUS .3 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0168-0424_f3ae5047-f195-4ad7-81e2-95862b388fa0 0168-0424 HUMAN PRESCRIPTION DRUG Adapalene adapalene CREAM TOPICAL 20100630 ANDA ANDA090824 E. Fougera & Co. A division of Fougera Pharmaceuticals Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0168-0432_fdbbf340-e87c-44ed-9274-148846ffd788 0168-0432 HUMAN PRESCRIPTION DRUG imiquimod imiquimod CREAM TOPICAL 20100225 ANDA ANDA078548 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] N 20181231 0168-0434_1e7daf9c-5707-40c1-bd3c-57c3812d4f9d 0168-0434 HUMAN PRESCRIPTION DRUG FLUTICASONE PROPIONATE fluticasone propionate LOTION TOPICAL 20121203 NDA AUTHORIZED GENERIC NDA021152 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUTICASONE PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0449_ceefbbf9-de5d-4e62-95b4-937d5d69f10c 0168-0449 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SHAMPOO TOPICAL 20100525 ANDA ANDA090146 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CICLOPIROX 10 mg/.96mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 0168-0457_f9c768b5-2f83-4fb7-a5cb-035789e1b1d6 0168-0457 HUMAN PRESCRIPTION DRUG fluocinonide fluocinonide CREAM TOPICAL 20140714 ANDA ANDA200735 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0168-0482_2f0c4bdf-185a-4e44-b7ea-ef3e763762b3 0168-0482 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide methscopolamine bromide TABLET ORAL 20110316 NDA AUTHORIZED GENERIC NDA008848 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. METHSCOPOLAMINE BROMIDE 2.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0168-0483_2f0c4bdf-185a-4e44-b7ea-ef3e763762b3 0168-0483 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide methscopolamine bromide TABLET ORAL 20110727 NDA AUTHORIZED GENERIC NDA008848 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0168-0484_cc939c60-abf2-40dd-af3c-87281e9fc1ca 0168-0484 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide Sodium Sulfacetamide SOLUTION TOPICAL 20100312 UNAPPROVED DRUG OTHER E. FOUGERA & Co., A division of Nycomed US Inc. SULFACETAMIDE SODIUM 100 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 0168-0522_9888b9d1-09b5-4fe0-a27b-6f7672c5f66c 0168-0522 HUMAN PRESCRIPTION DRUG Ciclopirox ciclopirox SHAMPOO TOPICAL 20121119 NDA AUTHORIZED GENERIC NDA021159 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. CICLOPIROX 10 mg/.96mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 0168-0803_84bf3d93-cb17-4119-9fbe-0ee94841e29d 0168-0803 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM diclofenac sodium GEL TOPICAL 20130506 NDA AUTHORIZED GENERIC NDA021005 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0168-0825_ca59d786-caf0-4d80-b093-ea51eaa0147c 0168-0825 HUMAN PRESCRIPTION DRUG acyclovir acyclovir OINTMENT TOPICAL 20160511 ANDA ANDA206633 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0168-0844_180ea225-9ba8-45e0-a333-7c3354f927e5 0168-0844 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM diclofenac sodium GEL TOPICAL 20130506 NDA AUTHORIZED GENERIC NDA021005 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0169-0081_8fad81e2-1d1f-4058-92ee-77f45dd2d7ea 0169-0081 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 20201031 NDA NDA020741 Novo Nordisk REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0169-0082_8fad81e2-1d1f-4058-92ee-77f45dd2d7ea 0169-0082 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 20201031 NDA NDA020741 Novo Nordisk REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0169-0084_8fad81e2-1d1f-4058-92ee-77f45dd2d7ea 0169-0084 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 20201031 NDA NDA020741 Novo Nordisk REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0169-1833_e7ea8689-2a6a-4b6a-8dbe-4b0acca6badc 0169-1833 HUMAN OTC DRUG Novolin R Human Insulin INJECTION, SOLUTION SUBCUTANEOUS 19910625 NDA NDA019938 Novo Nordisk INSULIN HUMAN 100 [iU]/mL N 20181231 0169-1834_cc946c87-d01f-4158-8d6a-569411d35da0 0169-1834 HUMAN OTC DRUG Novolin N Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 19910701 NDA NDA019959 Novo Nordisk INSULIN HUMAN 100 [iU]/mL N 20181231 0169-1837_66f314fc-b241-4e2f-b000-234883920013 0169-1837 HUMAN OTC DRUG Novolin 70/30 Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 19910625 NDA NDA019991 Novo Nordisk INSULIN HUMAN 100 [USP'U]/mL N 20181231 0169-2550_650a6e03-484a-4ae9-ab25-730eb679a102 0169-2550 HUMAN PRESCRIPTION DRUG Tresiba insulin degludec injection INJECTION, SOLUTION SUBCUTANEOUS 20150925 NDA NDA203314 Novo Nordisk INSULIN DEGLUDEC 200 U/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0169-2660_650a6e03-484a-4ae9-ab25-730eb679a102 0169-2660 HUMAN PRESCRIPTION DRUG Tresiba insulin degludec injection INJECTION, SOLUTION SUBCUTANEOUS 20150925 NDA NDA203314 Novo Nordisk INSULIN DEGLUDEC 100 U/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0169-2800_aae420f9-d706-4f3a-bd39-2913a572c2f1 0169-2800 HUMAN PRESCRIPTION DRUG Saxenda liraglutide INJECTION, SOLUTION SUBCUTANEOUS 20141231 NDA NDA206321 Novo Nordisk LIRAGLUTIDE 6 mg/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20181231 0169-2911_21335fe4-d395-4501-ac2a-2f20d7520da9 0169-2911 HUMAN PRESCRIPTION DRUG Xultophy 100/3.6 (insulin degludec and liraglutide) INJECTION, SOLUTION SUBCUTANEOUS 20161121 NDA NDA208583 Novo Nordisk INSULIN DEGLUDEC; LIRAGLUTIDE 100; 3.6 [iU]/mL; mg/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC],GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20181231 0169-3201_99de9d9d-052e-4e5f-9d5a-8fdee0271c80 0169-3201 HUMAN PRESCRIPTION DRUG Fiasp insulin aspart injection INJECTION, SOLUTION SUBCUTANEOUS 20171020 NDA NDA208751 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0169-3204_99de9d9d-052e-4e5f-9d5a-8fdee0271c80 0169-3204 HUMAN PRESCRIPTION DRUG Fiasp insulin aspart injection INJECTION, SOLUTION SUBCUTANEOUS 20171020 NDA NDA208751 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0169-3303_4c2ff137-76d4-4e7b-bc43-d5213052f4c7 0169-3303 HUMAN PRESCRIPTION DRUG NOVOLOG insulin aspart INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20010827 NDA NDA020986 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0169-3685_40f7ed5e-e45f-4ff7-837e-f7f05dccb92c 0169-3685 HUMAN PRESCRIPTION DRUG NovoLog Mix 70/30 insulin aspart INJECTION, SUSPENSION SUBCUTANEOUS 20011101 NDA NDA021172 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0169-3687_a0ad4ce8-1e36-4b1f-bcd2-d73a8680d764 0169-3687 HUMAN PRESCRIPTION DRUG Levemir insulin detemir INJECTION, SOLUTION SUBCUTANEOUS 20060327 NDA NDA021536 Novo Nordisk INSULIN DETEMIR 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0169-3696_40f7ed5e-e45f-4ff7-837e-f7f05dccb92c 0169-3696 HUMAN PRESCRIPTION DRUG NovoLog Mix 70/30 insulin aspart INJECTION, SUSPENSION SUBCUTANEOUS 20020911 NDA NDA021172 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0169-4060_8794d6d2-d6b3-42dc-8dd5-5a2abb8cdb4f 0169-4060 HUMAN PRESCRIPTION DRUG Victoza liraglutide INJECTION SUBCUTANEOUS 20100125 NDA NDA022341 Novo Nordisk LIRAGLUTIDE 6 mg/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20191231 0169-4132_4bf1fd54-6062-474d-9ad7-f02ce0d93051 0169-4132 HUMAN PRESCRIPTION DRUG Ozempic semaglutide INJECTION, SOLUTION SUBCUTANEOUS 20171206 NDA NDA209637 Novo Nordisk SEMAGLUTIDE 1.34 mg/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20191231 0169-4136_4bf1fd54-6062-474d-9ad7-f02ce0d93051 0169-4136 HUMAN PRESCRIPTION DRUG Ozempic semaglutide INJECTION, SOLUTION SUBCUTANEOUS 20171206 NDA NDA209637 Novo Nordisk SEMAGLUTIDE 1.34 mg/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20191231 0169-5174_4e5e39ed-904b-47bc-8ff0-b558fccfe689 0169-5174 HUMAN PRESCRIPTION DRUG Activella estradiol and norethindrone acetate TABLET, FILM COATED ORAL 20030722 20181031 NDA NDA020907 Novo Nordisk ESTRADIOL; NORETHINDRONE ACETATE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20191231 0169-5176_f420724b-ebef-4b17-8d39-097e40e755f1 0169-5176 HUMAN PRESCRIPTION DRUG Vagifem estradiol INSERT VAGINAL 20100111 NDA NDA020908 Novo Nordisk ESTRADIOL 10 ug/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0169-6338_4c2ff137-76d4-4e7b-bc43-d5213052f4c7 0169-6338 HUMAN PRESCRIPTION DRUG NOVOLOG insulin aspart INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20131031 NDA NDA020986 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0169-6339_4c2ff137-76d4-4e7b-bc43-d5213052f4c7 0169-6339 HUMAN PRESCRIPTION DRUG NOVOLOG insulin aspart INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20030122 NDA NDA020986 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0169-6438_a0ad4ce8-1e36-4b1f-bcd2-d73a8680d764 0169-6438 HUMAN PRESCRIPTION DRUG Levemir insulin detemir INJECTION, SOLUTION SUBCUTANEOUS 20131031 NDA NDA021536 Novo Nordisk INSULIN DETEMIR 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0169-7010_8b72a9bf-669a-4266-b212-6e4363d16903 0169-7010 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20080430 BLA BLA103665 Novo Nordisk N 20181231 0169-7013_b6677d0f-54bb-41a5-bb26-05d4bded89bd 0169-7013 PLASMA DERIVATIVE TRETTEN Coagulation Factor XIII A-Subunit (Recombinant) KIT 20131223 BLA BLA125398 Novo Nordisk N 20181231 0169-7020_8b72a9bf-669a-4266-b212-6e4363d16903 0169-7020 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20080430 BLA BLA103665 Novo Nordisk N 20181231 0169-7040_8b72a9bf-669a-4266-b212-6e4363d16903 0169-7040 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20100806 BLA BLA103665 Novo Nordisk N 20181231 0169-7050_8b72a9bf-669a-4266-b212-6e4363d16903 0169-7050 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20080430 BLA BLA103665 Novo Nordisk N 20181231 0169-7065_ae274602-1630-4efc-bff8-d0371a4bd48e 0169-7065 HUMAN PRESCRIPTION DRUG GlucaGen HypoKit glucagon hydrochloride KIT 20050622 NDA NDA020918 Novo Nordisk N 20181231 0169-7201_8b72a9bf-669a-4266-b212-6e4363d16903 0169-7201 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20121029 BLA BLA103665 Novo Nordisk N 20181231 0169-7202_8b72a9bf-669a-4266-b212-6e4363d16903 0169-7202 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20121029 BLA BLA103665 Novo Nordisk N 20181231 0169-7205_8b72a9bf-669a-4266-b212-6e4363d16903 0169-7205 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20121029 BLA BLA103665 Novo Nordisk N 20181231 0169-7208_8b72a9bf-669a-4266-b212-6e4363d16903 0169-7208 PLASMA DERIVATIVE NovoSeven RT Coagulation Factor VIIa (Recombinant) KIT 20121029 BLA BLA103665 Novo Nordisk N 20181231 0169-7501_4c2ff137-76d4-4e7b-bc43-d5213052f4c7 0169-7501 HUMAN PRESCRIPTION DRUG NOVOLOG insulin aspart INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20010827 NDA NDA020986 Novo Nordisk INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 0169-7703_5cbf4899-995f-4d83-b643-5b7b9c91c69e 0169-7703 HUMAN PRESCRIPTION DRUG Norditropin somatropin INJECTION, SOLUTION SUBCUTANEOUS 20090330 NDA NDA021148 Novo Nordisk SOMATROPIN 30 mg/3mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] N 20191231 0169-7704_5cbf4899-995f-4d83-b643-5b7b9c91c69e 0169-7704 HUMAN PRESCRIPTION DRUG Norditropin somatropin INJECTION, SOLUTION SUBCUTANEOUS 20050103 NDA NDA021148 Novo Nordisk SOMATROPIN 5 mg/1.5mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] N 20191231 0169-7705_5cbf4899-995f-4d83-b643-5b7b9c91c69e 0169-7705 HUMAN PRESCRIPTION DRUG Norditropin somatropin INJECTION, SOLUTION SUBCUTANEOUS 20060102 NDA NDA021148 Novo Nordisk SOMATROPIN 10 mg/1.5mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] N 20191231 0169-7708_5cbf4899-995f-4d83-b643-5b7b9c91c69e 0169-7708 HUMAN PRESCRIPTION DRUG Norditropin somatropin INJECTION, SOLUTION SUBCUTANEOUS 20050103 NDA NDA021148 Novo Nordisk SOMATROPIN 15 mg/1.5mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] N 20191231 0169-7810_8067bc27-56e4-4e19-a7ad-a8d714473f1a 0169-7810 PLASMA DERIVATIVE Novoeight Antihemophilic Factor (Recombinant) KIT 20150401 BLA BLA125466 Novo Nordisk N 20181231 0169-7815_8067bc27-56e4-4e19-a7ad-a8d714473f1a 0169-7815 PLASMA DERIVATIVE Novoeight Antihemophilic Factor (Recombinant) KIT 20150401 BLA BLA125466 Novo Nordisk N 20181231 0169-7820_8067bc27-56e4-4e19-a7ad-a8d714473f1a 0169-7820 PLASMA DERIVATIVE Novoeight Antihemophilic Factor (Recombinant) KIT 20150401 BLA BLA125466 Novo Nordisk N 20181231 0169-7825_8067bc27-56e4-4e19-a7ad-a8d714473f1a 0169-7825 PLASMA DERIVATIVE Novoeight Antihemophilic Factor (Recombinant) KIT 20150401 BLA BLA125466 Novo Nordisk N 20181231 0169-7830_8067bc27-56e4-4e19-a7ad-a8d714473f1a 0169-7830 PLASMA DERIVATIVE Novoeight Antihemophilic Factor (Recombinant) KIT 20150401 BLA BLA125466 Novo Nordisk N 20181231 0169-7850_8067bc27-56e4-4e19-a7ad-a8d714473f1a 0169-7850 PLASMA DERIVATIVE Novoeight Antihemophilic Factor (Recombinant) KIT 20150401 BLA BLA125466 Novo Nordisk N 20181231 0169-7901_d2bc15dc-ec6f-4b4a-b9a6-42fb1bce9529 0169-7901 HUMAN PRESCRIPTION DRUG REBINYN (Coagulation Factor IX (Recombinant), GlycoPEGylated) KIT 20171201 BLA BLA125611 Novo Nordisk N 20181231 0169-7902_d2bc15dc-ec6f-4b4a-b9a6-42fb1bce9529 0169-7902 HUMAN PRESCRIPTION DRUG REBINYN (Coagulation Factor IX (Recombinant), GlycoPEGylated) KIT 20171201 BLA BLA125611 Novo Nordisk N 20181231 0169-7905_d2bc15dc-ec6f-4b4a-b9a6-42fb1bce9529 0169-7905 HUMAN PRESCRIPTION DRUG REBINYN (Coagulation Factor IX (Recombinant), GlycoPEGylated) KIT 20171201 BLA BLA125611 Novo Nordisk N 20181231 0172-2083_5cf6e962-40ff-43a5-8b53-863332bafc68 0172-2083 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19730112 ANDA ANDA083177 Teva Pharmaceuticals USA, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0172-2089_5cf6e962-40ff-43a5-8b53-863332bafc68 0172-2089 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19800107 ANDA ANDA083177 Teva Pharmaceuticals USA, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0172-2907_21153410-8a2b-44ce-814e-869571a199ae 0172-2907 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831130 NDA NDA018413 IVAX Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0172-2908_21153410-8a2b-44ce-814e-869571a199ae 0172-2908 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831130 NDA NDA018413 IVAX Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0172-3925_7d45e266-b6b1-4d01-b2b4-58cd957d6628 0172-3925 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071307 Teva Pharmaceuticals USA, Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0172-3926_7d45e266-b6b1-4d01-b2b4-58cd957d6628 0172-3926 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071321 Teva Pharmaceuticals USA, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0172-3927_7d45e266-b6b1-4d01-b2b4-58cd957d6628 0172-3927 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071322 Teva Pharmaceuticals USA, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0172-4096_e8f44c56-6bdb-4b06-8c4f-dd5b8d4a272a 0172-4096 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072234 Teva Pharmaceuticals USA, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 0172-4097_e8f44c56-6bdb-4b06-8c4f-dd5b8d4a272a 0172-4097 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072235 Teva Pharmaceuticals USA, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 0172-4357_ecc3f459-efc6-4281-bc61-b2cd092c492b 0172-4357 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 19970912 ANDA ANDA075165 IVAX Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0172-4358_ecc3f459-efc6-4281-bc61-b2cd092c492b 0172-4358 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 19980401 ANDA ANDA075165 IVAX Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0172-4364_e0b7456a-b2d3-4cc6-b85e-bb6de9e93e69 0172-4364 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA074787 Teva Pharmaceuticals USA, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0172-4365_e0b7456a-b2d3-4cc6-b85e-bb6de9e93e69 0172-4365 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA074787 Teva Pharmaceuticals USA, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0172-4366_e0b7456a-b2d3-4cc6-b85e-bb6de9e93e69 0172-4366 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA074787 Teva Pharmaceuticals USA, Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0172-4960_380ca984-6e8f-45ad-8d0b-6b04c143fa6c 0172-4960 HUMAN PRESCRIPTION DRUG Flutamide Flutamide CAPSULE ORAL 20010919 20180531 ANDA ANDA075780 Teva Pharmaceuticals USA, Inc. FLUTAMIDE 125 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 0172-5032_77ab08d3-f07f-4c75-b70a-f4c2c7c8645e 0172-5032 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA075776 IVAX Pharmaceuticals, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0172-5033_77ab08d3-f07f-4c75-b70a-f4c2c7c8645e 0172-5033 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA075776 IVAX Pharmaceuticals, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0172-5034_77ab08d3-f07f-4c75-b70a-f4c2c7c8645e 0172-5034 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA075776 IVAX Pharmaceuticals, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0172-5240_56ae5267-4bc1-4420-94a0-75df1567ca68 0172-5240 HUMAN PRESCRIPTION DRUG Anagrelide Hydrochloride Anagrelide Hydrochloride CAPSULE ORAL 20050418 ANDA ANDA076468 Teva Pharmaceuticals USA, Inc ANAGRELIDE HYDROCHLORIDE 1 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0172-5241_56ae5267-4bc1-4420-94a0-75df1567ca68 0172-5241 HUMAN PRESCRIPTION DRUG Anagrelide Hydrochloride Anagrelide Hydrochloride CAPSULE ORAL 20050418 ANDA ANDA076468 Teva Pharmaceuticals USA, Inc ANAGRELIDE HYDROCHLORIDE .5 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0172-5311_56c03a61-1bd6-4d6e-8f03-a3f4b4f0af11 0172-5311 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076089 Teva Pharmaceuticals USA, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0172-5312_56c03a61-1bd6-4d6e-8f03-a3f4b4f0af11 0172-5312 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076089 Teva Pharmaceuticals USA, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0172-5313_56c03a61-1bd6-4d6e-8f03-a3f4b4f0af11 0172-5313 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076089 Teva Pharmaceuticals USA, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0172-5410_9ca2e5e1-be3c-4df3-b2dc-93c9b6f3a2a2 0172-5410 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 Teva Pharmaceuticals USA, Inc. FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0172-5411_9ca2e5e1-be3c-4df3-b2dc-93c9b6f3a2a2 0172-5411 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 Teva Pharmaceuticals USA, Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0172-5412_9ca2e5e1-be3c-4df3-b2dc-93c9b6f3a2a2 0172-5412 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 Teva Pharmaceuticals USA, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0172-5413_9ca2e5e1-be3c-4df3-b2dc-93c9b6f3a2a2 0172-5413 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 Teva Pharmaceuticals USA, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0172-5728_8f47e4db-2671-4cf7-aa1d-2133df14acd0 0172-5728 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075511 Teva Pharmaceuticals USA, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0172-5729_8f47e4db-2671-4cf7-aa1d-2133df14acd0 0172-5729 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075511 Teva Pharmaceuticals USA, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0172-6406_97a916f6-2c8f-4c08-8562-9402c7af7715 0172-6406 HUMAN PRESCRIPTION DRUG Cromolyn Sodium Cromolyn Sodium SOLUTION INTRABRONCHIAL 20000118 ANDA ANDA075271 IVAX Pharmaceuticals, Inc. CROMOLYN SODIUM 20 mg/2mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 0172-7313_ebbd1abb-1ce7-422a-a5b3-b01abcc4ab39 0172-7313 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine SOLUTION ORAL 20050329 ANDA ANDA065078 IVAX Pharmaceuticals, Inc. CYCLOSPORINE 100 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0173-0135_4eb95aa8-63d6-4f69-a2a5-555d6a2d7c0f 0173-0135 HUMAN PRESCRIPTION DRUG WELLBUTRIN SR bupropion hydrochloride TABLET, FILM COATED ORAL 19961115 NDA NDA020358 GlaxoSmithKline LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0173-0387_82f16275-f129-470a-aa15-158b15c227d8 0173-0387 HUMAN PRESCRIPTION DRUG CEFTIN cefuroxime axetil TABLET, FILM COATED ORAL 19891001 20180430 NDA NDA050605 GlaxoSmithKline LLC CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0173-0388_17600f11-d034-4c3d-974f-8287b42db37a 0173-0388 HUMAN PRESCRIPTION DRUG BECONASE AQ beclomethasone dipropionate monohydrate SPRAY, SUSPENSION NASAL 19891001 NDA NDA019389 GlaxoSmithKline LLC BECLOMETHASONE DIPROPIONATE MONOHYDRATE 42 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0173-0393_ba6e71f4-1034-451f-87a9-80374c1a8c43 0173-0393 HUMAN PRESCRIPTION DRUG ZANTAC ranitidine hydrochloride TABLET, FILM COATED ORAL 19891001 NDA NDA018703 GlaxoSmithKline LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 0173-0442_a0443f0b-1c2e-4f08-98b2-473769b18b36 0173-0442 HUMAN PRESCRIPTION DRUG ZOFRAN ondansetron hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19910204 20180228 NDA NDA020007 GlaxoSmithKline LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0173-0446_611b5ddf-6ba0-4811-b040-29004102f56c 0173-0446 HUMAN PRESCRIPTION DRUG ZOFRAN ondansetron hydrochloride TABLET, FILM COATED ORAL 19930211 20190228 NDA NDA020103 GlaxoSmithKline LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0173-0447_611b5ddf-6ba0-4811-b040-29004102f56c 0173-0447 HUMAN PRESCRIPTION DRUG ZOFRAN ondansetron hydrochloride TABLET, FILM COATED ORAL 19930211 20200229 NDA NDA020103 GlaxoSmithKline LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0173-0449_4c2517b2-a5c5-414d-bc0c-762c9bc19196 0173-0449 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate INJECTION SUBCUTANEOUS 19930223 NDA NDA020080 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0173-0478_4c2517b2-a5c5-414d-bc0c-762c9bc19196 0173-0478 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate INJECTION SUBCUTANEOUS 19970127 NDA NDA020080 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0173-0479_4c2517b2-a5c5-414d-bc0c-762c9bc19196 0173-0479 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate INJECTION SUBCUTANEOUS 19970123 NDA NDA020080 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0173-0489_611b5ddf-6ba0-4811-b040-29004102f56c 0173-0489 HUMAN PRESCRIPTION DRUG ZOFRAN ondansetron hydrochloride SOLUTION ORAL 19970205 20190630 NDA NDA020605 GlaxoSmithKline LLC ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0173-0517_b9f0d662-3e2d-4681-944d-cd320ff65321 0173-0517 HUMAN PRESCRIPTION DRUG FLOLAN epoprostenol sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19951208 NDA NDA020444 GlaxoSmithKline LLC EPOPROSTENOL SODIUM .5 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 0173-0518_b9f0d662-3e2d-4681-944d-cd320ff65321 0173-0518 HUMAN PRESCRIPTION DRUG Diluent water SOLUTION INTRAVENOUS 20030506 NDA NDA020444 GlaxoSmithKline LLC N 20181231 0173-0519_b9f0d662-3e2d-4681-944d-cd320ff65321 0173-0519 HUMAN PRESCRIPTION DRUG FLOLAN epoprostenol sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19951208 NDA NDA020444 GlaxoSmithKline LLC EPOPROSTENOL SODIUM 1.5 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 0173-0520_cf2a6bca-db87-42e2-b279-018a75e231a1 0173-0520 HUMAN PRESCRIPTION DRUG SEREVENT DISKUS salmeterol xinafoate POWDER, METERED ORAL; RESPIRATORY (INHALATION) 19971201 NDA NDA020692 GlaxoSmithKline LLC SALMETEROL XINAFOATE 50 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0173-0521_cf2a6bca-db87-42e2-b279-018a75e231a1 0173-0521 HUMAN PRESCRIPTION DRUG SEREVENT DISKUS salmeterol xinafoate POWDER, METERED ORAL; RESPIRATORY (INHALATION) 19971125 NDA NDA020692 GlaxoSmithKline LLC SALMETEROL XINAFOATE 50 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0173-0523_c6f52e57-6421-46b5-bf03-caa7748a4de6 0173-0523 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan SPRAY NASAL 19970918 NDA NDA020626 GlaxoSmithKline LLC SUMATRIPTAN 20 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0173-0524_c6f52e57-6421-46b5-bf03-caa7748a4de6 0173-0524 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan SPRAY NASAL 19971010 NDA NDA020626 GlaxoSmithKline LLC SUMATRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0173-0526_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0526 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET, CHEWABLE ORAL 19980904 NDA NDA020764 GlaxoSmithKline LLC LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0527_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0527 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET, CHEWABLE ORAL 19980903 NDA NDA020764 GlaxoSmithKline LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0547_97061221-24f2-435b-8dc9-dd6862dddc81 0173-0547 HUMAN PRESCRIPTION DRUG MEPRON atovaquone SUSPENSION ORAL 19980918 NDA NDA020500 GlaxoSmithKline LLC ATOVAQUONE 750 mg/5mL Antimalarial [EPC],Antiprotozoal [EPC] N 20181231 0173-0556_07cd5f8d-868e-4a62-9914-87da273a5d1a 0173-0556 HUMAN PRESCRIPTION DRUG ZYBAN bupropion hydrochloride TABLET, FILM COATED ORAL 19970528 NDA NDA020711 GlaxoSmithKline LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0173-0561_a9d8f1ce-fc3e-424b-b126-4d14238506db 0173-0561 HUMAN PRESCRIPTION DRUG AMERGE naratriptan hydrochloride TABLET, FILM COATED ORAL 19980226 NDA NDA020763 GlaxoSmithKline LLC NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0173-0562_a9d8f1ce-fc3e-424b-b126-4d14238506db 0173-0562 HUMAN PRESCRIPTION DRUG AMERGE naratriptan hydrochloride TABLET, FILM COATED ORAL 19980226 NDA NDA020763 GlaxoSmithKline LLC NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0173-0565_cbab13fe-873d-489f-887a-1b9c5c50fa46 0173-0565 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 20020812 NDA NDA020487 GlaxoSmithKline LLC VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0173-0570_611b5ddf-6ba0-4811-b040-29004102f56c 0173-0570 HUMAN PRESCRIPTION DRUG ZOFRAN ODT ondansetron hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 19990301 20180228 NDA NDA020781 GlaxoSmithKline LLC ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0173-0594_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0594 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine KIT 20030929 NDA NDA020241 GlaxoSmithKline LLC N 20181231 0173-0600_ee079a6a-c48a-4c2a-9ddb-645ca39b907a 0173-0600 HUMAN PRESCRIPTION DRUG FLOVENT DISKUS fluticasone propionate POWDER, METERED RESPIRATORY (INHALATION) 20070508 NDA NDA020833 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0173-0601_ee079a6a-c48a-4c2a-9ddb-645ca39b907a 0173-0601 HUMAN PRESCRIPTION DRUG FLOVENT DISKUS fluticasone propionate POWDER, METERED RESPIRATORY (INHALATION) 20081013 NDA NDA020833 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 250 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0173-0602_ee079a6a-c48a-4c2a-9ddb-645ca39b907a 0173-0602 HUMAN PRESCRIPTION DRUG FLOVENT DISKUS fluticasone propionate POWDER, METERED RESPIRATORY (INHALATION) 20081013 NDA NDA020833 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 100 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0173-0633_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0633 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19960815 NDA NDA020241 GlaxoSmithKline LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0642_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0642 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19950117 NDA NDA020241 GlaxoSmithKline LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0643_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0643 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19950117 NDA NDA020241 GlaxoSmithKline LLC LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0644_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0644 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19950118 NDA NDA020241 GlaxoSmithKline LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0662_3f46fa8c-6d88-4d25-b097-58400b784b31 0173-0662 HUMAN PRESCRIPTION DRUG EPIVIR HBV lamivudine TABLET, FILM COATED ORAL 19981217 NDA NDA021003 GlaxoSmithKline LLC LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0173-0663_3f46fa8c-6d88-4d25-b097-58400b784b31 0173-0663 HUMAN PRESCRIPTION DRUG EPIVIR HBV lamivudine SOLUTION ORAL 19981223 NDA NDA021004 GlaxoSmithKline LLC LAMIVUDINE 5 mg/mL Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0173-0665_97061221-24f2-435b-8dc9-dd6862dddc81 0173-0665 HUMAN PRESCRIPTION DRUG MEPRON atovaquone SUSPENSION ORAL 19950228 NDA NDA020500 GlaxoSmithKline LLC ATOVAQUONE 750 mg/5mL Antimalarial [EPC],Antiprotozoal [EPC] N 20181231 0173-0675_a7e07c5d-13b1-4279-a33c-fc07bb36bad4 0173-0675 HUMAN PRESCRIPTION DRUG MALARONE atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20000726 NDA NDA021078 GlaxoSmithKline LLC ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 0173-0676_a7e07c5d-13b1-4279-a33c-fc07bb36bad4 0173-0676 HUMAN PRESCRIPTION DRUG MALARONE atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20000726 NDA NDA021078 GlaxoSmithKline LLC ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5; 25 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 0173-0681_0f2e4250-582a-49f6-9615-e4bb5f566271 0173-0681 HUMAN PRESCRIPTION DRUG RELENZA zanamivir POWDER RESPIRATORY (INHALATION) 19990922 NDA NDA021036 GlaxoSmithKline LLC ZANAMIVIR 5 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] N 20181231 0173-0682_8fd0a504-67ca-4b71-addc-5f1006fc6372 0173-0682 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 GlaxoSmithKline LLC ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0173-0695_7a57b774-9976-453c-bb03-c784603a262d 0173-0695 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010228 NDA NDA021077 GlaxoSmithKline LLC SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 100 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0173-0696_7a57b774-9976-453c-bb03-c784603a262d 0173-0696 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010205 NDA NDA021077 GlaxoSmithKline LLC SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 250 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0173-0697_7a57b774-9976-453c-bb03-c784603a262d 0173-0697 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010305 NDA NDA021077 GlaxoSmithKline LLC SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 500 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0173-0699_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0699 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET, CHEWABLE ORAL 20001012 NDA NDA020764 GlaxoSmithKline LLC LAMOTRIGINE 2 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0712_2aa99314-961b-4c45-9809-09af8a8dc806 0173-0712 HUMAN PRESCRIPTION DRUG AVODART dutasteride CAPSULE, LIQUID FILLED ORAL 20021210 NDA NDA021319 GlaxoSmithKline LLC DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 0173-0715_b078f8e7-a260-42db-abf1-b1cae5c61220 0173-0715 HUMAN PRESCRIPTION DRUG ADVAIR HFA fluticasone propionate and salmeterol xinafoate AEROSOL, METERED RESPIRATORY (INHALATION) 20080929 NDA NDA021254 GlaxoSmithKline LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 45; 21 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0173-0716_b078f8e7-a260-42db-abf1-b1cae5c61220 0173-0716 HUMAN PRESCRIPTION DRUG ADVAIR HFA fluticasone propionate and salmeterol xinafoate AEROSOL, METERED RESPIRATORY (INHALATION) 20080929 NDA NDA021254 GlaxoSmithKline LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 115; 21 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0173-0717_b078f8e7-a260-42db-abf1-b1cae5c61220 0173-0717 HUMAN PRESCRIPTION DRUG ADVAIR HFA fluticasone propionate and salmeterol xinafoate AEROSOL, METERED RESPIRATORY (INHALATION) 20090306 NDA NDA021254 GlaxoSmithKline LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 230; 21 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0173-0718_5a0e6d88-058d-466b-8eba-4985d7947138 0173-0718 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20070406 NDA NDA021433 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 44 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0173-0719_5a0e6d88-058d-466b-8eba-4985d7947138 0173-0719 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20070129 NDA NDA021433 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 110 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0173-0720_5a0e6d88-058d-466b-8eba-4985d7947138 0173-0720 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20070125 NDA NDA021433 GlaxoSmithKline LLC FLUTICASONE PROPIONATE 220 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0173-0722_4eb95aa8-63d6-4f69-a2a5-555d6a2d7c0f 0173-0722 HUMAN PRESCRIPTION DRUG WELLBUTRIN SR bupropion hydrochloride TABLET, FILM COATED ORAL 20020625 NDA NDA020358 GlaxoSmithKline LLC BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0173-0735_37bf1eaf-2b8c-4c5b-bc06-08dca57279c6 0173-0735 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate TABLET, FILM COATED ORAL 20031217 NDA NDA020132 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0173-0736_37bf1eaf-2b8c-4c5b-bc06-08dca57279c6 0173-0736 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate TABLET, FILM COATED ORAL 20031217 NDA NDA020132 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0173-0737_37bf1eaf-2b8c-4c5b-bc06-08dca57279c6 0173-0737 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate TABLET, FILM COATED ORAL 20031219 NDA NDA020132 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0173-0739_4c2517b2-a5c5-414d-bc0c-762c9bc19196 0173-0739 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate INJECTION SUBCUTANEOUS 20060406 NDA NDA020080 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE 4 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0173-0740_82f16275-f129-470a-aa15-158b15c227d8 0173-0740 HUMAN PRESCRIPTION DRUG CEFTIN cefuroxime axetil POWDER, FOR SUSPENSION ORAL 20040602 20180930 NDA NDA050672 GlaxoSmithKline LLC CEFUROXIME AXETIL 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0173-0741_82f16275-f129-470a-aa15-158b15c227d8 0173-0741 HUMAN PRESCRIPTION DRUG CEFTIN cefuroxime axetil POWDER, FOR SUSPENSION ORAL 20040602 20180930 NDA NDA050672 GlaxoSmithKline LLC CEFUROXIME AXETIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0173-0750_33607e05-3cfe-4e44-9a3b-aec5d2062c8e 0173-0750 HUMAN PRESCRIPTION DRUG TREXIMET sumatriptan and naproxen sodium TABLET, FILM COATED ORAL 20080425 20180731 NDA NDA021926 GlaxoSmithKline LLC SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM 85; 500 mg/1; mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 0173-0753_1ddb118d-95f4-4e03-b7f1-403e1ad6e82a 0173-0753 HUMAN PRESCRIPTION DRUG VERAMYST fluticasone furoate SPRAY, METERED NASAL 20070515 20190731 NDA NDA022051 GlaxoSmithKline LLC FLUTICASONE FUROATE 27.5 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0173-0754_e2ba6eea-a212-4c39-bc00-4c30ee386753 0173-0754 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090706 NDA NDA022115 GlaxoSmithKline LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0755_e2ba6eea-a212-4c39-bc00-4c30ee386753 0173-0755 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090706 NDA NDA022115 GlaxoSmithKline LLC LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0756_e2ba6eea-a212-4c39-bc00-4c30ee386753 0173-0756 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090706 NDA NDA022115 GlaxoSmithKline LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0757_e2ba6eea-a212-4c39-bc00-4c30ee386753 0173-0757 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090706 NDA NDA022115 GlaxoSmithKline LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0758_e2ba6eea-a212-4c39-bc00-4c30ee386753 0173-0758 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine KIT 20090706 NDA NDA022115 GlaxoSmithKline LLC N 20181231 0173-0759_e2ba6eea-a212-4c39-bc00-4c30ee386753 0173-0759 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine KIT 20090706 NDA NDA022115 GlaxoSmithKline LLC N 20181231 0173-0760_e2ba6eea-a212-4c39-bc00-4c30ee386753 0173-0760 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine KIT 20090706 NDA NDA022115 GlaxoSmithKline LLC N 20181231 0173-0761_e2ba6eea-a212-4c39-bc00-4c30ee386753 0173-0761 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110331 NDA NDA022115 GlaxoSmithKline LLC LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0772_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0772 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20090605 NDA NDA022251 GlaxoSmithKline LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0774_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0774 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20090605 NDA NDA022251 GlaxoSmithKline LLC LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0776_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0776 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20090605 NDA NDA022251 GlaxoSmithKline LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0777_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0777 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20090605 NDA NDA022251 GlaxoSmithKline LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0778_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0778 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine KIT 20090605 NDA NDA022251 GlaxoSmithKline LLC N 20181231 0173-0779_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0779 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine KIT 20090605 NDA NDA022251 GlaxoSmithKline LLC N 20181231 0173-0780_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0780 HUMAN PRESCRIPTION DRUG LAMICTAL ODT lamotrigine KIT 20090605 NDA NDA022251 GlaxoSmithKline LLC N 20181231 0173-0781_e2ba6eea-a212-4c39-bc00-4c30ee386753 0173-0781 HUMAN PRESCRIPTION DRUG LAMICTAL XR lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110815 NDA NDA022115 GlaxoSmithKline LLC LAMOTRIGINE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0173-0783_35939775-e816-47fc-aa7e-a6c5b27e9074 0173-0783 HUMAN PRESCRIPTION DRUG LOVAZA omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20081021 20191031 NDA NDA021654 GlaxoSmithKline LLC OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 0173-0809_f8541685-f609-4814-926b-f4350a5f982a 0173-0809 HUMAN PRESCRIPTION DRUG JALYN dutasteride and tamsulosin hydrochloride CAPSULE ORAL 20100621 NDA NDA022460 GlaxoSmithKline LLC DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE .5; .4 mg/1; mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA],Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0173-0810_efb88eb8-a497-4139-bc4f-865fd499d88d 0173-0810 HUMAN PRESCRIPTION DRUG POTIGA ezogabine TABLET, FILM COATED ORAL 20120419 20190731 NDA NDA022345 GlaxoSmithKline LLC EZOGABINE 50 mg/1 Potassium Channel Openers [MoA],Potassium Channel Opener [EPC] CV N 20181231 0173-0812_efb88eb8-a497-4139-bc4f-865fd499d88d 0173-0812 HUMAN PRESCRIPTION DRUG POTIGA ezogabine TABLET, FILM COATED ORAL 20120419 20190731 NDA NDA022345 GlaxoSmithKline LLC EZOGABINE 200 mg/1 Potassium Channel Openers [MoA],Potassium Channel Opener [EPC] CV N 20181231 0173-0813_efb88eb8-a497-4139-bc4f-865fd499d88d 0173-0813 HUMAN PRESCRIPTION DRUG POTIGA ezogabine TABLET, FILM COATED ORAL 20120419 20180831 NDA NDA022345 GlaxoSmithKline LLC EZOGABINE 300 mg/1 Potassium Channel Openers [MoA],Potassium Channel Opener [EPC] CV N 20181231 0173-0814_efb88eb8-a497-4139-bc4f-865fd499d88d 0173-0814 HUMAN PRESCRIPTION DRUG POTIGA ezogabine TABLET, FILM COATED ORAL 20120419 20190630 NDA NDA022345 GlaxoSmithKline LLC EZOGABINE 400 mg/1 Potassium Channel Openers [MoA],Potassium Channel Opener [EPC] CV N 20181231 0173-0817_7b528a65-c04f-4c2a-b5fb-3be65beae027 0173-0817 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine KIT 20030929 NDA NDA020241 GlaxoSmithKline LLC N 20181231 0173-0822_36095c49-9046-4150-af0b-ac0e8435e066 0173-0822 HUMAN PRESCRIPTION DRUG Staxyn vardenafil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110421 NDA NDA200179 GlaxoSmithKline LLC VARDENAFIL HYDROCHLORIDE 11.85 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0173-0823_738b940d-bde1-4c75-8f85-1a0ba51ae588 0173-0823 HUMAN PRESCRIPTION DRUG RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110317 NDA NDA021416 GlaxoSmithKline LLC PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] N 20181231 0173-0824_738b940d-bde1-4c75-8f85-1a0ba51ae588 0173-0824 HUMAN PRESCRIPTION DRUG RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110317 NDA NDA021416 GlaxoSmithKline LLC PROPAFENONE HYDROCHLORIDE 325 mg/1 Antiarrhythmic [EPC] N 20181231 0173-0826_738b940d-bde1-4c75-8f85-1a0ba51ae588 0173-0826 HUMAN PRESCRIPTION DRUG RYTHMOL SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110317 NDA NDA021416 GlaxoSmithKline LLC PROPAFENONE HYDROCHLORIDE 425 mg/1 Antiarrhythmic [EPC] N 20181231 0173-0828_4e53cf84-85f4-4597-9f54-29689231fd0e 0173-0828 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20030825 NDA NDA021400 GlaxoSmithKline LLC VARDENAFIL HYDROCHLORIDE 2.5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0173-0829_4e53cf84-85f4-4597-9f54-29689231fd0e 0173-0829 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20030423 NDA NDA021400 GlaxoSmithKline LLC VARDENAFIL HYDROCHLORIDE 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0173-0830_4e53cf84-85f4-4597-9f54-29689231fd0e 0173-0830 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20030825 NDA NDA021400 GlaxoSmithKline LLC VARDENAFIL HYDROCHLORIDE 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0173-0831_4e53cf84-85f4-4597-9f54-29689231fd0e 0173-0831 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20030825 NDA NDA021400 GlaxoSmithKline LLC VARDENAFIL HYDROCHLORIDE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0173-0846_58d54d18-76cb-4ac1-beb3-da8db45c28b1 0173-0846 HUMAN PRESCRIPTION DRUG Tafinlar dabrafenib CAPSULE ORAL 20130610 20180831 NDA NDA202806 GlaxoSmithKline LLC DABRAFENIB MESYLATE 50 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Organic Anion Transporter 1 Inhibitors [MoA],Organic Anion Transporter 3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20191231 0173-0847_58d54d18-76cb-4ac1-beb3-da8db45c28b1 0173-0847 HUMAN PRESCRIPTION DRUG Tafinlar dabrafenib CAPSULE ORAL 20130610 20180531 NDA NDA202806 GlaxoSmithKline LLC DABRAFENIB MESYLATE 75 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Organic Anion Transporter 1 Inhibitors [MoA],Organic Anion Transporter 3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20191231 0173-0859_de557194-155f-41d3-8bf4-11926cf9927a 0173-0859 HUMAN PRESCRIPTION DRUG Breo Ellipta fluticasone furoate and vilanterol trifenatate POWDER RESPIRATORY (INHALATION) 20130826 NDA NDA204275 GlaxoSmithKline LLC FLUTICASONE FUROATE; VILANTEROL TRIFENATATE 100; 25 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0173-0861_293856d5-bf3f-4df6-a3bc-80482b128ad2 0173-0861 HUMAN PRESCRIPTION DRUG AVANDIA 2MG rosiglitazone maleate TABLET, FILM COATED ORAL 20110525 NDA NDA021071 GlaxoSmithKline LLC ROSIGLITAZONE MALEATE 2 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 0173-0863_293856d5-bf3f-4df6-a3bc-80482b128ad2 0173-0863 HUMAN PRESCRIPTION DRUG AVANDIA 4MG rosiglitazone maleate TABLET, FILM COATED ORAL 20110525 NDA NDA021071 GlaxoSmithKline LLC ROSIGLITAZONE MALEATE 4 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 0173-0866_63519e77-7af1-4667-9c90-4bc82b18ee0f 0173-0866 HUMAN PRESCRIPTION DRUG Tanzeum albiglutide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20140415 BLA BLA125431 GlaxoSmithKline LLC ALBIGLUTIDE 30 mg/.5mL GLP-1 Receptor Agonist [EPC],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20181231 0173-0867_63519e77-7af1-4667-9c90-4bc82b18ee0f 0173-0867 HUMAN PRESCRIPTION DRUG Tanzeum albiglutide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20140415 BLA BLA125431 GlaxoSmithKline LLC ALBIGLUTIDE 50 mg/.5mL GLP-1 Receptor Agonist [EPC],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20181231 0173-0869_096cef06-00ef-4797-998b-20a93c6d0896 0173-0869 HUMAN PRESCRIPTION DRUG Anoro Ellipta umeclidinium bromide and vilanterol trifenatate POWDER RESPIRATORY (INHALATION) 20140131 NDA NDA203975 GlaxoSmithKline LLC UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE 62.5; 25 ug/1; ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0173-0873_1b9451c9-5180-475e-add7-87294ad92252 0173-0873 HUMAN PRESCRIPTION DRUG Incruse Ellipta umeclidinium AEROSOL, POWDER ORAL 20140430 NDA NDA205382 GlaxoSmithKline LLC UMECLIDINIUM BROMIDE 62.5 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0173-0874_e35b7445-e339-47be-b98a-5e3204ffdf69 0173-0874 HUMAN PRESCRIPTION DRUG Arnuity Ellipta fluticasone furoate POWDER RESPIRATORY (INHALATION) 20140820 NDA NDA205625 GlaxoSmithKline LLC FLUTICASONE FUROATE 100 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0173-0876_e35b7445-e339-47be-b98a-5e3204ffdf69 0173-0876 HUMAN PRESCRIPTION DRUG Arnuity Ellipta fluticasone furoate POWDER RESPIRATORY (INHALATION) 20140820 NDA NDA205625 GlaxoSmithKline LLC FLUTICASONE FUROATE 200 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0173-0881_602099da-0906-42c0-b299-0299fc51fe4c 0173-0881 HUMAN PRESCRIPTION DRUG Nucala mepolizumab INJECTION, POWDER, FOR SOLUTION SUBCUTANEOUS 20151104 BLA BLA125526 GlaxoSmithKline LLC MEPOLIZUMAB 100 mg/mL Interleukin-5 Antagonist [EPC],Interleukin-5 Antagonists [MoA] N 20181231 0173-0882_de557194-155f-41d3-8bf4-11926cf9927a 0173-0882 HUMAN PRESCRIPTION DRUG Breo Ellipta fluticasone furoate and vilanterol trifenatate POWDER RESPIRATORY (INHALATION) 20150430 NDA NDA204275 GlaxoSmithKline LLC FLUTICASONE FUROATE; VILANTEROL TRIFENATATE 200; 25 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0173-0884_35939775-e816-47fc-aa7e-a6c5b27e9074 0173-0884 HUMAN PRESCRIPTION DRUG LOVAZA omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20160519 NDA NDA021654 GlaxoSmithKline LLC OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 0173-0887_c550bb69-ea8e-4ff6-9b45-7c99e3eaad1b 0173-0887 HUMAN PRESCRIPTION DRUG Trelegy Ellipta fluticasone furoate, umeclidinium bromide and vilanterol trifenatate POWDER RESPIRATORY (INHALATION) 20170918 NDA NDA209482 GlaxoSmithKline LLC FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE 100; 62.5; 25 ug/1; ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0173-0933_cbab13fe-873d-489f-887a-1b9c5c50fa46 0173-0933 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 19950801 NDA NDA020487 GlaxoSmithKline LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0173-0947_4eb95aa8-63d6-4f69-a2a5-555d6a2d7c0f 0173-0947 HUMAN PRESCRIPTION DRUG WELLBUTRIN SR bupropion hydrochloride TABLET, FILM COATED ORAL 19961115 NDA NDA020358 GlaxoSmithKline LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0178-0089_5a08d10f-fd1c-2b35-e053-2991aa0a0336 0178-0089 HUMAN PRESCRIPTION DRUG Ferralet 90 iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium TABLET, FILM COATED ORAL 20100204 UNAPPROVED DRUG OTHER Mission Pharmacal Company IRON; FOLIC ACID; CYANOCOBALAMIN; ASCORBIC ACID; DOCUSATE SODIUM 90; 1; 12; 120; 50 mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20181231 0178-0101_ff81be48-e01a-2163-4c61-2a2437d3ae88 0178-0101 HUMAN PRESCRIPTION DRUG Binosto alendronate sodium TABLET, EFFERVESCENT ORAL 20120903 NDA NDA202344 Mission Pharmacal Company ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0178-0314_d9e02a48-8129-9076-78b2-db01750bd220 0178-0314 HUMAN OTC DRUG POTASSIUM IODIDE POTASSIUM IODIDE SOLUTION ORAL 20160515 ANDA ANDA206211 Mission Pharmacal Company POTASSIUM IODIDE 65 mg/mL N 20181231 0178-0320_5e955a76-91a2-f507-e053-2991aa0a63de 0178-0320 HUMAN OTC DRUG Theragesic Creme METHYL SALICYLATE GEL TOPICAL 19810101 OTC MONOGRAPH NOT FINAL part348 Mission Pharmacal Company METHYL SALICYLATE; MENTHOL 150; 10 mg/g; mg/g N 20181231 0178-0330_5f8b336a-90a7-6ede-e053-2991aa0aacfd 0178-0330 HUMAN OTC DRUG DR SMITHS DIAPER Zinc Oxide OINTMENT TOPICAL 20100301 OTC MONOGRAPH FINAL part347 Mission Pharmacal ZINC OXIDE 100 mg/g N 20181231 0178-0340_5fb35787-077f-5dc1-e053-2a91aa0a0849 0178-0340 HUMAN OTC DRUG Dr Smiths Diaper Rash Zinc Oxide SPRAY TOPICAL 20140407 OTC MONOGRAPH FINAL part347 Mission Pharmacal Company ZINC OXIDE 10 g/100g N 20181231 0178-0345_0a6b5d7c-e58c-a07a-392a-3bac2a390602 0178-0345 HUMAN OTC DRUG Dr Smiths Diaper Rash Zinc Oxide SPRAY TOPICAL 20140407 OTC MONOGRAPH FINAL part347 Mission Pharmacal Company ZINC OXIDE 10 g/100g N 20181231 0178-0348_5fc13f71-9627-5f94-e053-2a91aa0a30ab 0178-0348 HUMAN OTC DRUG Dr Smiths Diaper Rash Zinc Oxide SPRAY TOPICAL 20140407 OTC MONOGRAPH FINAL part347 Mission Pharmacal Company ZINC OXIDE 10 g/100g N 20181231 0178-0350_5f0b69d3-79ce-9d1e-d19a-10eefc5573bf 0178-0350 HUMAN OTC DRUG Theragesic Plus METHYL SALICYLATE GEL TOPICAL 19810101 OTC MONOGRAPH NOT FINAL part348 Mission Pharmacal Company METHYL SALICYLATE; MENTHOL 250; 40 mg/g; mg/g N 20181231 0178-0370_e6e61eea-73a0-3936-c648-b87771c24102 0178-0370 HUMAN OTC DRUG Dr. Smiths Rash and Skin Zinc Oxide OINTMENT TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Mission Pharmacal Company ZINC OXIDE 10 g/100g E 20171231 0178-0455_2915df51-4fbd-41ee-ac57-cb302593fb6d 0178-0455 HUMAN PRESCRIPTION DRUG Texacort Hydrocortisone SOLUTION TOPICAL 20111215 ANDA ANDA081271 Mission Pharmacal Company HYDROCORTISONE 25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0178-0460_51f0a2b3-a22b-172b-e054-00144ff88e88 0178-0460 HUMAN PRESCRIPTION DRUG Avar-e Green SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0465_52029c63-4b35-015b-e054-00144ff88e88 0178-0465 HUMAN PRESCRIPTION DRUG Avar-e LS SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0470_520207cd-0457-2573-e054-00144ff8d46c 0178-0470 HUMAN PRESCRIPTION DRUG Avar-e SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0475_5331b982-e2ce-5e87-e054-00144ff8d46c 0178-0475 HUMAN PRESCRIPTION DRUG AVAR LS SULFACETAMIDE SODIUM, SULFUR EMULSION TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0480_52554fdc-667f-6176-e054-00144ff88e88 0178-0480 HUMAN PRESCRIPTION DRUG AVAR SULFACETAMIDE SODIUM, SULFUR EMULSION TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0485_51f1ef5c-d6eb-45ff-e054-00144ff88e88 0178-0485 HUMAN PRESCRIPTION DRUG OVACE Plus SULFACETAMIDE SODIUM SHAMPOO TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0490_48bbd70d-f654-291b-e054-00144ff8d46c 0178-0490 HUMAN PRESCRIPTION DRUG OVACE Plus SULFACETAMIDE SODIUM LIQUID TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0495_602b2613-51ab-0e16-e053-2a91aa0a2ccd 0178-0495 HUMAN PRESCRIPTION DRUG OvacePlus Plus SULFACETAMIDE SODIUM CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 100 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0499_602b0d04-7d3c-3d37-e053-2991aa0a367a 0178-0499 HUMAN PRESCRIPTION DRUG OVACE SULFACETAMIDE SODIUM LIQUID TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0500_6660b616-a82d-9109-19ce-2bdf9747acea 0178-0500 HUMAN PRESCRIPTION DRUG Lithostat acetohydroxamic acid TABLET ORAL 19830531 NDA NDA018749 Mission Pharmacal Company ACETOHYDROXAMIC ACID 250 mg/1 Urease Inhibitor [EPC],Urease Inhibitors [MoA] N 20181231 0178-0513_05e900d7-3b87-4166-b213-b9e26c65ff14 0178-0513 HUMAN PRESCRIPTION DRUG Utira-C methenamine, sodium phosphate monobasic, phenyl salicylate, methylene blue, hyoscyamine sulfate TABLET ORAL 20110911 UNAPPROVED DRUG OTHER Mission Pharmacal Company METHENAMINE; SODIUM PHOSPHATE, MONOBASIC; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE 81.6; 40.8; 36.2; 10.8; .12 mg/1; mg/1; mg/1; mg/1; mg/1 Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] E 20171231 0178-0582_9d525542-655c-db2b-046b-572a3017a1bf 0178-0582 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Oral Solution Prednisolone Sodium Phosphate SOLUTION ORAL 20121001 ANDA ANDA091396 Mission Pharmacal Company PREDNISOLONE SODIUM PHOSPHATE 25 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0178-0600_a3e35a2c-fcb2-768b-57da-c2eb7818f3ff 0178-0600 HUMAN PRESCRIPTION DRUG UROCIT-K potassium citrate TABLET, EXTENDED RELEASE ORAL 19850901 NDA NDA019071 Mission Pharmacal Company POTASSIUM CITRATE 5 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0178-0610_a3e35a2c-fcb2-768b-57da-c2eb7818f3ff 0178-0610 HUMAN PRESCRIPTION DRUG UROCIT-K potassium citrate TABLET, EXTENDED RELEASE ORAL 19920901 NDA NDA019071 Mission Pharmacal Company POTASSIUM CITRATE 10 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0178-0615_a3e35a2c-fcb2-768b-57da-c2eb7818f3ff 0178-0615 HUMAN PRESCRIPTION DRUG UROCIT-K potassium citrate TABLET, EXTENDED RELEASE ORAL 20100127 NDA NDA019071 Mission Pharmacal Company POTASSIUM CITRATE 15 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0178-0620_602b2250-e751-6498-e053-2991aa0a3b87 0178-0620 HUMAN PRESCRIPTION DRUG Ovace Plus SULFACETAMIDE SODIUM LOTION TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 98 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0630_51d8bb58-8cce-4cee-e054-00144ff88e88 0178-0630 HUMAN PRESCRIPTION DRUG OVACE PLUS SODIUM SULFACETAMIDE LIQUID TOPICAL 20110907 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0640_602b2250-e733-6498-e053-2991aa0a3b87 0178-0640 HUMAN PRESCRIPTION DRUG Avar LS Cleansing Pads SULFACETAMIDE SODIUM, SULFUR CLOTH TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0650_602b2250-e743-6498-e053-2991aa0a3b87 0178-0650 HUMAN PRESCRIPTION DRUG Avar Cleansing Pads SULFACETAMIDE SODIUM, SULFUR CLOTH TOPICAL 20110915 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 95; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0653_4de9dcfb-3c69-65bb-e054-00144ff88e88 0178-0653 HUMAN PRESCRIPTION DRUG Avar LS SODIUM SULFACETAMIDE, SULFUR AEROSOL, FOAM TOPICAL 20100715 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0658_4db28298-290e-47dd-e054-00144ff8d46c 0178-0658 HUMAN PRESCRIPTION DRUG Avar SODIUM SULFACETAMIDE, SULFUR AEROSOL, FOAM TOPICAL 20100715 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFUR; SULFACETAMIDE SODIUM 50; 95 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0696_1948a935-c939-3f05-e054-00144ff88e88 0178-0696 HUMAN PRESCRIPTION DRUG Ovace Plus SODIUM SULFACETAMIDE AEROSOL, FOAM TOPICAL 20100715 UNAPPROVED DRUG OTHER Mission Pharmacal Company SULFACETAMIDE SODIUM 98 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0178-0716_53d06b85-b69b-4ac6-9c55-3fa2e80fdcf2 0178-0716 HUMAN PRESCRIPTION DRUG NataFort Ascorbic acid, Cholecalciferol, .alpha.-tocopherol acetate, dl-, Thiamine mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, and Iron TABLET ORAL 20110825 UNAPPROVED DRUG OTHER Mission Pharmacal Company ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; IRON 120; 400; 11; 2; 3; 20; 10; 1; 12; 60 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 0178-0796_5ef80316-38cb-6b0d-e053-2a91aa0a9c77 0178-0796 HUMAN PRESCRIPTION DRUG CitraNatal Harmony 3.0 Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent CAPSULE, GELATIN COATED ORAL 20140321 UNAPPROVED DRUG OTHER Mission Pharmacal Company CALCIUM CITRATE; IRON; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; PYRIDOXINE; FOLIC ACID; DOCUSATE SODIUM; DOCONEXENT 104; 27; 400; 30; 25; 1; 50; 260 mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0178-0797_00ecf076-d840-bee7-38d1-48bae1066bff 0178-0797 HUMAN PRESCRIPTION DRUG Citranatal Harmony 2.1 Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent CAPSULE, GELATIN COATED ORAL 20130121 UNAPPROVED DRUG OTHER NDA0123456 Mission Pharmacal Company CALCIUM CITRATE; IRON 104; 29 mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0178-0798_8b4cf96f-8706-4121-ab4f-3a469a945d97 0178-0798 HUMAN PRESCRIPTION DRUG CitraNatal Harmony Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent CAPSULE, GELATIN COATED ORAL 20120115 UNAPPROVED DRUG OTHER MISSION PHARMACAL COMPANY CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; DOCUSATE SODIUM; DOCONEXENT 104; 30; 400; 30; 25; 1; 50; 260 mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0178-0799_779591fd-fd24-40fe-870f-df1f1c914b22 0178-0799 HUMAN PRESCRIPTION DRUG CitraNatal Harmony Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-tocopherol, DL-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent CAPSULE, GELATIN COATED ORAL 20110418 UNAPPROVED DRUG OTHER MISSION PHARMACAL COMPANY CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; DOCUSATE SODIUM; DOCONEXENT 100; 28; 400; 30; 25; 1; 50; 250 mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0178-0812_ffeb77e7-167b-4049-aa46-81ec06f218d1 0178-0812 HUMAN PRESCRIPTION DRUG CitraNatal Harmony Calcium citrate, Iron pentacarbonyl, Cholecalciferol, Alpha-tocopherol, DL-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent CAPSULE, GELATIN COATED ORAL 20100427 UNAPPROVED DRUG OTHER MISSION PHARMACAL COMPANY CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; DOCUSATE SODIUM; DOCONEXENT 100; 27; 400; 30; 25; 1; 50; 250 mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0178-0813_5a09148f-42e6-50ae-e053-2a91aa0ac9e3 0178-0813 HUMAN PRESCRIPTION DRUG CitraNatal Bloom iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium TABLET, FILM COATED ORAL 20170801 UNAPPROVED DRUG OTHER Mission Pharmacal Company ASCORBIC ACID; IRON PENTACARBONYL; DOCUSATE SODIUM; FERROUS GLUCONATE; FOLIC ACID; CYANOCOBALAMIN 138; 88.5; 55; 13.2; 1.4; 16.8 mg/1; mg/1; mg/1; mg/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 0178-0816_63004034-123e-c9c8-e053-2991aa0a359a 0178-0816 HUMAN PRESCRIPTION DRUG CitraNatal Bloom DHA iron, folic acid, cyanocobalamin, ascorbic acid, docusate sodium and DHA KIT ORAL 20180118 UNAPPROVED DRUG OTHER Mission Pharmacal Company N 20191231 0178-0821_0635dd94-500a-53a2-9de6-7de205257063 0178-0821 HUMAN PRESCRIPTION DRUG CitraNatal 90 DHA Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium TABLET ORAL 20140411 UNAPPROVED DRUG OTHER Mission Pharmacal Company ASCORBIC ACID; IRON; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM; CALCIUM CITRATE; THIAMINE MONONITRATE; POTASSIUM IODIDE; FERROUS GLUCONATE; VITAMIN D; RIBOFLAVIN 120; 85; 30; 3; 20; 20; 1; 25; 2; 50; 159; 4.54; 150; 5; 400; 3.4 mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; [iU]/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0178-0829_62d662f4-a16f-fca3-3bd7-2a407c7bbd13 0178-0829 HUMAN OTC DRUG CitraNatal 90 DHA Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium TABLET ORAL 20100201 UNAPPROVED DRUG OTHER Mission Pharmacal Company ASCORBIC ACID; CALCIUM CITRATE; IRON; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE; RIBOPRINE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; POTASSIUM TRIIODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM 120; 160; 90; 400; 30; 3; 3.4; 20; 20; 1; 150; 25; 2; 50 mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1 N 20181231 0178-0832_5e956879-b2e7-b281-e053-2991aa0ad1dc 0178-0832 HUMAN PRESCRIPTION DRUG CITRANATAL B-CALM ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid KIT 20120618 UNAPPROVED DRUG OTHER Mission Pharmacal Company N 20181231 0178-0858_c02cc80c-adb1-5582-6f60-d819a1e41748 0178-0858 HUMAN PRESCRIPTION DRUG CitraNatal Rx Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium TABLET ORAL 20140811 UNAPPROVED DRUG OTHER Mission Pharmacal Company ASCORBIC ACID; CALCIUM CITRATE; IRON; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; POTASSIUM IODIDE; ZINC OXIDE; CUPRIC OXIDE 120; 124; 27; 400; 30; 3; 3.4; 20; 20; 1; 150; 25; 2 mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 0178-0859_8ee7be74-6442-5692-edab-5d8626a510dd 0178-0859 HUMAN PRESCRIPTION DRUG CitraNatal Rx Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium TABLET ORAL 20071126 UNAPPROVED DRUG OTHER Mission Pharmacal Company ASCORBIC ACID; CALCIUM CITRATE; IRON; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; POTASSIUM IODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM 120; 125; 27; 400; 30; 3; 3.4; 20; 20; 1; 150; 25; 2; 50 mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 0178-0866_03d6e2ba-0ef8-48ad-ab6f-959bfbabbbf7 0178-0866 HUMAN PRESCRIPTION DRUG CitraNatal B-Calm Ascorbic Acid, Calcium Citrate, Iron Pentacarbonyl, Cholecalciferol, Pyridoxine Hydrochloride, Folic Acid KIT 20100210 UNAPPROVED DRUG OTHER Mission Pharmacal Company E 20171231 0178-0891_5fc5dc13-7c3f-f601-e053-2991aa0a7d2c 0178-0891 HUMAN PRESCRIPTION DRUG CitraNatal Assure ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent KIT 20140430 UNAPPROVED DRUG OTHER Mission Pharmacal Company N 20181231 0178-0893_5e1b9d10-6c66-4108-9e93-c59d729cd91d 0178-0893 HUMAN PRESCRIPTION DRUG CitraNatal Assure ascorbic acid, calcium citrate, iron, vitamin d, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, DOCONE KIT 20081119 UNAPPROVED DRUG OTHER Mission Pharmacal Company N 20181231 0178-0894_60dd8389-809f-d8a9-e053-2a91aa0a0a2b 0178-0894 HUMAN PRESCRIPTION DRUG CitraNatal DHA Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium KIT 20140522 UNAPPROVED DRUG OTHER Mission Pharmacal Company N 20181231 0178-0898_32943e5e-f2c2-25de-6075-6ca42c87adb5 0178-0898 HUMAN OTC DRUG CitraNatal DHA Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium TABLET ORAL 20071120 UNAPPROVED DRUG OTHER Mission Pharmacal Company ASCORBIC ACID; CALCIUM CITRATE; IRON; VITAMIN D; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; POTASSIUM IODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM 120; 125; 27; 400; 30; 3; 3.4; 20; 20; 1; 150; 25; 2; 50 mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 N 20181231 0178-0900_494a714e-923c-cd57-df6c-12886afb265a 0178-0900 HUMAN PRESCRIPTION DRUG Thiola tiopronin TABLET, SUGAR COATED ORAL 19880811 NDA NDA019569 Mission Pharmacal Company TIOPRONIN 100 mg/1 Cystine Disulfide Reduction [MoA],N-substituted Glycines [Chemical/Ingredient],Reducing and Complexing Thiol [EPC] N 20181231 0178-3291_43234c34-6971-2099-7618-b7bc536e9e9f 0178-3291 HUMAN PRESCRIPTION DRUG HYCOFENIX hydrocodone bitartrate, pseudoephedrine hydrochloride, guaifenesin LIQUID ORAL 20150818 NDA NDA022279 Mission Pharmacal Company GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 2.5; 30 mg/5mL; mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CII N 20181231 0178-3482_bd2a5d0b-9a77-4f25-de68-114c43fa0c2c 0178-3482 HUMAN PRESCRIPTION DRUG Flowtuss HYDROCODONE BITARTRATE, GUAIFENESIN LIQUID ORAL 20150818 NDA NDA022424 Mission Pharmacal Company GUAIFENESIN; HYDROCODONE BITARTRATE 200; 2.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0178-8250_94492a08-570c-4176-a871-0977fd44d4fa 0178-8250 HUMAN PRESCRIPTION DRUG Tindamax tinidazole TABLET, FILM COATED ORAL 20040517 NDA NDA021618 Mission Pharmacal Company TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0178-8500_94492a08-570c-4176-a871-0977fd44d4fa 0178-8500 HUMAN PRESCRIPTION DRUG Tindamax tinidazole TABLET, FILM COATED ORAL 20040517 NDA NDA021618 Mission Pharmacal Company TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0179-0014_6b062984-4ea5-467c-8aaa-80d9aae6f622 0179-0014 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20110524 ANDA ANDA076119 KAISER FOUNDATION HOSPITALS MIRTAZAPINE 15 mg/1 N 20181231 0179-0015_7e711e7d-e229-48c9-b60c-9dcbdd49934f 0179-0015 HUMAN PRESCRIPTION DRUG Chlorthalidone Chlorthalidone TABLET ORAL 20090608 ANDA ANDA087180 KAISER FOUNDATION HOSPITALS CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0179-0016_0746e5d8-3971-4ad3-a558-7b13f5376f3d 0179-0016 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20090801 ANDA ANDA075347 KAISER FOUNDATION HOSPITALS OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0179-0018_a157b128-5d58-42b4-8567-cd67fc9ad5e9 0179-0018 HUMAN PRESCRIPTION DRUG LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM TABLET ORAL 20090829 ANDA ANDA090097 KAISER FOUNDATION HOSPITALS LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 0179-0019_750673fb-53e1-4c54-a610-8932cef47a0b 0179-0019 HUMAN PRESCRIPTION DRUG LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM TABLET ORAL 20090828 ANDA ANDA090097 KAISER FOUNDATION HOSPITALS LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 0179-0022_75cfa992-7b8f-4895-ae89-3432b57cafe2 0179-0022 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091001 ANDA ANDA079095 KAISER FOUNDATION HOSPITALS BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0179-0023_f1ac382c-d74a-4b01-9e16-fa9e115e9264 0179-0023 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090901 NDA NDA050162 KAISER FOUNDATION HOSPITALS CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0179-0024_f1ac382c-d74a-4b01-9e16-fa9e115e9264 0179-0024 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090901 NDA NDA050162 KAISER FOUNDATION HOSPITALS CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0179-0025_85af4b0d-ad6e-4417-9972-fbcf87c5fd34 0179-0025 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20090901 ANDA ANDA075584 KAISER FOUNDATION HOSPITALS BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0179-0028_0c80436e-c57d-4cf7-afb4-a3d70e4fb5d4 0179-0028 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20100127 ANDA ANDA078957 KAISER FOUNDATION HOSPITALS STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0179-0030_75cfa992-7b8f-4895-ae89-3432b57cafe2 0179-0030 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090831 ANDA ANDA079095 KAISER FOUNDATION HOSPITALS BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0179-0033_36fb50e0-6e27-4be6-b3c9-f98dd116ad41 0179-0033 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20090901 ANDA ANDA065150 KAISER FOUNDATION HOSPITALS AZITHROMYCIN 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0179-0034_3db6ea40-7654-4370-bf87-a4ad16ff0c3e 0179-0034 HUMAN PRESCRIPTION DRUG DILANTIN PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20090920 ANDA ANDA084349 KAISER FOUNDATION HOSPITALS PHENYTOIN SODIUM 30 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0179-0037_435c3587-89b7-43f3-a297-6348d04c80ed 0179-0037 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, COATED ORAL 20091030 ANDA ANDA077836 KAISER FOUNDATION HOSPITALS GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 0179-0039_9164a7ef-b869-4973-a552-062674d5b878 0179-0039 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene hydrochlorothiazide TABLET ORAL 20091123 ANDA ANDA072011 KAISER FOUNDATION HOSPITALS TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0179-0040_d975babc-6b9a-4101-84b2-a457140d56a4 0179-0040 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20091130 ANDA ANDA078558 KAISER FOUNDATION HOSPITALS IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0179-0043_459ffa04-c0ff-48e6-b562-37cc9ff91783 0179-0043 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20100212 20180531 NDA NDA022127 KAISER FOUNDATION HOSPITALS SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20191231 0179-0045_02ea979b-92fa-405a-b81c-4edcbefbc7bb 0179-0045 HUMAN PRESCRIPTION DRUG TEMAZEPAM temazepam CAPSULE ORAL 20100323 NDA NDA018163 KAISER FOUNDATION HOSPITALS TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-0048_8353922d-e8c9-4070-9747-cb84a5907b44 0179-0048 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, COATED ORAL 20100127 ANDA ANDA077836 KAISER FOUNDATION HOSPITALS GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 0179-0050_e2fd95d6-8efa-427e-a22a-e7497eaa9ce0 0179-0050 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20100209 ANDA ANDA040904 KAISER FOUNDATION HOSPITALS ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 0179-0054_6b696dde-63cd-4c84-be57-bc1e50af323b 0179-0054 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20100226 ANDA ANDA076126 KAISER FOUNDATION HOSPITALS CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0179-0055_b4e0a4ae-4dbf-49a9-95ef-2d69b312abd0 0179-0055 HUMAN PRESCRIPTION DRUG KETOCONAZOLE KETOCONAZOLE TABLET ORAL 20100302 ANDA ANDA075597 KAISER FOUNDATION HOSPITALS KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0179-0056_c4d6eb90-2394-45b9-9c40-613d756fd43a 0179-0056 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 20100305 ANDA ANDA040761 KAISER FOUNDATION HOSPITALS HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0179-0057_097befaa-8c25-45de-a559-00299974a850 0179-0057 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20100302 ANDA ANDA077563 KAISER FOUNDATION HOSPITALS CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0179-0058_c4d6eb90-2394-45b9-9c40-613d756fd43a 0179-0058 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 20100305 ANDA ANDA040761 KAISER FOUNDATION HOSPITALS HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0179-0060_0dc31683-61c6-408c-b535-044914e900d8 0179-0060 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20100414 ANDA ANDA075245 KAISER FOUNDATION HOSPITALS FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0179-0063_e28d2e41-88d1-44a8-8efe-c95c7bb342c9 0179-0063 HUMAN PRESCRIPTION DRUG Rocaltrol calcitriol CAPSULE, GELATIN COATED ORAL 20100604 NDA NDA018044 KAISER FOUNDATION HOSPITALS CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0179-0065_bbc7e4c5-d18c-462b-a8c7-bcaabc0e0ab4 0179-0065 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100607 ANDA ANDA040907 KAISER FOUNDATION HOSPITALS HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0179-0066_32804aff-dd7f-49ca-a036-93ce855b40a9 0179-0066 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20100621 20181031 ANDA ANDA040627 KAISER FOUNDATION HOSPITALS BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 0179-0068_9cd2b991-c3fa-4c04-99db-c4b64c6396cf 0179-0068 HUMAN PRESCRIPTION DRUG ANASTROZOLE ANASTROZOLE TABLET ORAL 20100713 ANDA ANDA079220 KAISER FOUNDATION HOSPITALS ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0179-0069_e28d2e41-88d1-44a8-8efe-c95c7bb342c9 0179-0069 HUMAN PRESCRIPTION DRUG Rocaltrol calcitriol CAPSULE, GELATIN COATED ORAL 20100809 NDA NDA018044 KAISER FOUNDATION HOSPITALS CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0179-0071_6b062984-4ea5-467c-8aaa-80d9aae6f622 0179-0071 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20101007 ANDA ANDA076119 KAISER FOUNDATION HOSPITALS MIRTAZAPINE 30 mg/1 N 20181231 0179-0072_229c10c3-acef-4b91-b161-edc42adc8658 0179-0072 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20101008 ANDA ANDA088618 KAISER FOUNDATION HOSPITALS HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0179-0073_f97fdb38-50b1-46d2-bd1f-98960dabb33e 0179-0073 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 20101007 ANDA ANDA040326 KAISER FOUNDATION HOSPITALS ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0179-0074_f97fdb38-50b1-46d2-bd1f-98960dabb33e 0179-0074 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 20101020 ANDA ANDA040326 KAISER FOUNDATION HOSPITALS ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0179-0075_229c10c3-acef-4b91-b161-edc42adc8658 0179-0075 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20101008 ANDA ANDA088618 KAISER FOUNDATION HOSPITALS HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0179-0079_8850bb3d-e16c-4c47-9156-9c3f61bddb83 0179-0079 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20101210 ANDA ANDA065461 KAISER FOUNDATION HOSPITALS TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0179-0080_cbfd0b5a-23a7-46f6-89b6-2b1dd92e6cb9 0179-0080 HUMAN PRESCRIPTION DRUG Nuvigil ARMODAFINIL TABLET ORAL 20110128 NDA NDA021875 KAISER FOUNDATION HOSPITALS ARMODAFINIL 250 mg/1 CIV N 20181231 0179-0082_cbfd0b5a-23a7-46f6-89b6-2b1dd92e6cb9 0179-0082 HUMAN PRESCRIPTION DRUG Nuvigil ARMODAFINIL TABLET ORAL 20110128 NDA NDA021875 KAISER FOUNDATION HOSPITALS ARMODAFINIL 50 mg/1 CIV N 20181231 0179-0083_506833f8-eea6-4714-bf2b-dd6a159d5362 0179-0083 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20110215 ANDA ANDA078920 KAISER FOUNDATION HOSPITALS PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0179-0087_625b618a-b57c-45cc-9052-de0586e1997f 0179-0087 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20110315 NDA NDA020564 KAISER FOUNDATION HOSPITALS LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0179-0088_a06eea26-45e9-4849-b789-5dcceab7e78f 0179-0088 HUMAN PRESCRIPTION DRUG DONNATAL BELLADONNA ALKALOIDS W/ PHENOBARBITAL ELIXIR ORAL 20110330 UNAPPROVED DRUG OTHER KAISER FOUNDATION HOSPITALS PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0179-0089_eb4f1418-2342-4174-a448-1335dea53deb 0179-0089 HUMAN PRESCRIPTION DRUG CAFERGOT Ergotamine Tartrate and Caffeine TABLET ORAL 20110421 ANDA ANDA084294 KAISER FOUNDATION HOSPITALS ERGOTAMINE TARTRATE; CAFFEINE 1; 100 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0179-0090_f481691b-d760-420e-a1df-e1c6ff084cb4 0179-0090 HUMAN PRESCRIPTION DRUG DARAPRIM pyrimethamine TABLET ORAL 20110420 NDA NDA008578 KAISER FOUNDATION HOSPITALS PYRIMETHAMINE 25 mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 0179-0091_91ac7b9e-7290-4397-a097-7e1f487bb463 0179-0091 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20110426 ANDA ANDA076509 KAISER FOUNDATION HOSPITALS FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 0179-0092_1b3fb004-351e-4301-83e3-420619f7ec48 0179-0092 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20110606 ANDA ANDA090200 KAISER FOUNDATION HOSPITALS METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0179-0093_ca0b258f-54fb-4f66-ae18-83d45c1702f9 0179-0093 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20110608 ANDA ANDA074342 KAISER FOUNDATION HOSPITALS ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-0094_ca0b258f-54fb-4f66-ae18-83d45c1702f9 0179-0094 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20110608 ANDA ANDA074342 KAISER FOUNDATION HOSPITALS ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-0095_1b3fb004-351e-4301-83e3-420619f7ec48 0179-0095 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20110607 ANDA ANDA090200 KAISER FOUNDATION HOSPITALS METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0179-0099_5fbfa44c-a26e-47aa-82a1-b496375622f5 0179-0099 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET ORAL 20110912 ANDA ANDA077851 KAISER FOUNDATION HOSPITALS ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0179-0100_5fbfa44c-a26e-47aa-82a1-b496375622f5 0179-0100 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET ORAL 20110912 ANDA ANDA077851 KAISER FOUNDATION HOSPITALS ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0179-0101_38e8ad75-0f1b-49dd-bf4e-6a6d51a8b476 0179-0101 HUMAN PRESCRIPTION DRUG ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA040009 KAISER FOUNDATION HOSPITALS ISOSORBIDE DINITRATE 40 mg/1 N 20181231 0179-0102_cb3bc5aa-99ed-4705-951a-a2220ef78016 0179-0102 HUMAN PRESCRIPTION DRUG LEVITRA VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20111028 NDA NDA021400 KAISER FOUNDATION HOSPITALS VARDENAFIL HYDROCHLORIDE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0179-0103_91ac7b9e-7290-4397-a097-7e1f487bb463 0179-0103 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20110803 ANDA ANDA076509 KAISER FOUNDATION HOSPITALS FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 0179-0104_7b839750-2c0c-41f2-a0d3-09f5a9902ba9 0179-0104 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120106 NDA AUTHORIZED GENERIC NDA019839 KAISER FOUNDATION HOSPITALS SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0179-0105_2118df83-73ab-4150-babc-8b48aacd80af 0179-0105 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET, FILM COATED ORAL 20120106 ANDA ANDA060359 KAISER FOUNDATION HOSPITALS ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0179-0107_dcbbc15f-bfe1-43aa-9559-572c4e88a729 0179-0107 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET ORAL 20120105 ANDA ANDA078301 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0179-0108_dcbbc15f-bfe1-43aa-9559-572c4e88a729 0179-0108 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET ORAL 20120105 ANDA ANDA078301 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0179-0109_dcbbc15f-bfe1-43aa-9559-572c4e88a729 0179-0109 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET ORAL 20120105 ANDA ANDA078301 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0179-0110_508792d2-f09b-4cab-9bd7-b58734b649f9 0179-0110 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20120213 ANDA ANDA074185 KAISER FOUNDATION HOSPITALS DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0179-0111_5efdc7de-6f5f-4922-990d-8aa55938d4f1 0179-0111 HUMAN PRESCRIPTION DRUG ASACOL mesalamine TABLET, DELAYED RELEASE ORAL 20120223 NDA NDA019651 KAISER FOUNDATION HOSPITALS MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0179-0115_bc719866-7046-47e0-9506-1d0b79cdc582 0179-0115 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20120509 ANDA ANDA075682 KAISER FOUNDATION HOSPITALS IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0179-0117_a85e64fd-e5e2-4382-a3f1-8c5ae18c2314 0179-0117 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN Erythromycin CAPSULE, DELAYED RELEASE ORAL 20120426 ANDA ANDA062746 KAISER FOUNDATION HOSPITALS ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0179-0118_aca972ce-fb7a-45eb-82a3-f970669bb658 0179-0118 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 20120531 ANDA ANDA088292 KAISER FOUNDATION HOSPITALS IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0179-0119_bc719866-7046-47e0-9506-1d0b79cdc582 0179-0119 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20120605 ANDA ANDA075682 KAISER FOUNDATION HOSPITALS IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0179-0120_18864075-2cd2-4c15-97e2-a50be9963bc5 0179-0120 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20120531 ANDA ANDA074430 KAISER FOUNDATION HOSPITALS DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0179-0122_06763473-e347-4170-8d55-da76c813795e 0179-0122 HUMAN PRESCRIPTION DRUG Methylergonovine Maleate Methylergonovine Maleate TABLET ORAL 20120531 ANDA ANDA091577 KAISER FOUNDATION HOSPITALS METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 0179-0123_906c42de-5239-4b1e-bef8-479a7e652283 0179-0123 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20120912 ANDA ANDA040197 KAISER FOUNDATION HOSPITALS ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0179-0124_2b664604-2426-4739-ad47-c487c569a2fe 0179-0124 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20120912 ANDA ANDA040189 KAISER FOUNDATION HOSPITALS METHYLPREDNISOLONE 16 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0179-0125_8db227a4-f232-4c2c-af4c-65afcac2f396 0179-0125 HUMAN PRESCRIPTION DRUG LODOSYN CARBIDOPA TABLET ORAL 20120925 NDA NDA017830 KAISER FOUNDATION HOSPITALS CARBIDOPA 25 mg/1 N 20181231 0179-0126_312d8e1a-cce2-4410-9473-1638d78df5fb 0179-0126 HUMAN PRESCRIPTION DRUG EDECRIN ethacrynic acid TABLET ORAL 20130110 NDA NDA016092 KAISER FOUNDATION HOSPITALS ETHACRYNIC ACID 25 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0179-0127_8ad17089-6918-418d-91ee-6cee09494c11 0179-0127 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20130115 ANDA ANDA071851 KAISER FOUNDATION HOSPITALS TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0179-0128_13b2a26c-df43-4eb1-9983-84de90cccd55 0179-0128 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130201 ANDA ANDA076052 KAISER FOUNDATION HOSPITALS SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0179-0129_5ed9d185-f5dd-4d83-bd04-4492dc8df0f1 0179-0129 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20130314 ANDA ANDA065285 KAISER FOUNDATION HOSPITALS DOXYCYCLINE 100 mg/1 N 20181231 0179-0131_0dc4bedf-b51f-487e-b2f2-a8f5f950cf41 0179-0131 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20130311 ANDA ANDA071403 KAISER FOUNDATION HOSPITALS LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-0132_50813ed1-f3b5-4bed-84cf-0fe5bbf1b46c 0179-0132 HUMAN PRESCRIPTION DRUG Donnatal Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide TABLET ORAL 20130702 UNAPPROVED DRUG OTHER KAISER FOUNDATION HOSPITALS PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0179-0133_4486fcc5-d3d8-40d9-bf0a-2f8965dd54fc 0179-0133 HUMAN PRESCRIPTION DRUG Mephyton phytonadione TABLET ORAL 20130729 NDA NDA010104 KAISER FOUNDATION HOSPITALS PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 0179-0135_10055ce4-847f-456b-949b-b8697a318d9f 0179-0135 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130805 ANDA ANDA077321 KAISER FOUNDATION HOSPITALS LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0179-0137_3d4b2003-5ac2-4d6f-b699-e984faad9cff 0179-0137 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20130819 ANDA ANDA040511 KAISER FOUNDATION HOSPITALS BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 0179-0138_8facf54f-8e6a-45f1-b1de-a3a9d8fedbaf 0179-0138 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130924 ANDA ANDA076899 KAISER FOUNDATION HOSPITALS SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0179-0140_395e3e23-a8a2-4552-afb1-f4b9737fa5fb 0179-0140 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline TABLET ORAL 20140428 ANDA ANDA065070 KAISER FOUNDATION HOSPITALS DOXYCYCLINE 100 mg/1 N 20181231 0179-0141_3239efd9-7d23-4ac4-87d7-fb7df36019e0 0179-0141 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20131105 NDA AUTHORIZED GENERIC NDA020702 KAISER FOUNDATION HOSPITALS ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0179-0142_5d64a942-c06b-4182-9b7d-eb29e910d4a7 0179-0142 HUMAN PRESCRIPTION DRUG Lialda mesalamine TABLET, DELAYED RELEASE ORAL 20131206 NDA NDA022000 KAISER FOUNDATION HOSPITALS MESALAMINE 1.2 g/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0179-0143_48c67779-1716-4aa6-bcde-1e5803f74503 0179-0143 HUMAN PRESCRIPTION DRUG Rilutek riluzole TABLET ORAL 20140120 NDA NDA020599 KAISER FOUNDATION HOSPITALS RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] N 20181231 0179-0144_b5ae5515-870d-4baf-8f24-e71d83ee91e1 0179-0144 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140120 ANDA ANDA090778 KAISER FOUNDATION HOSPITALS DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0179-0146_5faf7ef7-7894-4739-a34f-f02aaa6ba325 0179-0146 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140311 ANDA ANDA063083 KAISER FOUNDATION HOSPITALS CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0179-0147_5faf7ef7-7894-4739-a34f-f02aaa6ba325 0179-0147 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140311 ANDA ANDA063083 KAISER FOUNDATION HOSPITALS CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0179-0148_ae73fe84-3592-4606-a09d-e624cff2d23e 0179-0148 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140428 ANDA ANDA071403 KAISER FOUNDATION HOSPITALS LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-0149_54ec910c-7486-4de2-ab26-b5d185939197 0179-0149 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20140514 ANDA ANDA091649 KAISER FOUNDATION HOSPITALS CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0179-0150_a361dab4-4407-4297-83e9-45e1ab7d3df1 0179-0150 HUMAN PRESCRIPTION DRUG Riluzole Riluzole TABLET, FILM COATED ORAL 20140514 ANDA ANDA091417 KAISER FOUNDATION HOSPITALS RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] N 20181231 0179-0151_e31d1911-11a1-4342-b05f-dd3da73ca3fb 0179-0151 HUMAN PRESCRIPTION DRUG Raloxifene hydrochloride Raloxifene hydrochloride TABLET ORAL 20140529 NDA AUTHORIZED GENERIC NDA020815 KAISER FOUNDATION HOSPITALS RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0179-0152_2240bccc-9851-42bc-ba78-f8cf8f2ae82c 0179-0152 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20140529 ANDA ANDA202941 KAISER FOUNDATION HOSPITALS LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0179-0153_6de478f3-9c92-4097-9948-232df518468c 0179-0153 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET, FILM COATED ORAL 20140529 ANDA ANDA077220 KAISER FOUNDATION HOSPITALS PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 0179-0154_abffd938-0045-4af6-9a78-bb2f730beff1 0179-0154 HUMAN PRESCRIPTION DRUG Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate TABLET ORAL 20140707 UNAPPROVED DRUG OTHER KAISER FOUNDATION HOSPITALS SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 852; 155; 130 mg/1; mg/1; mg/1 N 20181231 0179-0155_4a695bb4-09c6-472d-96db-f38564263242 0179-0155 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20140903 NDA AUTHORIZED GENERIC NDA008697 KAISER FOUNDATION HOSPITALS HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0179-0157_81e118df-add9-4dde-8cfa-e6a7ef58cd69 0179-0157 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20140903 ANDA ANDA078554 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0179-0158_81e118df-add9-4dde-8cfa-e6a7ef58cd69 0179-0158 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20140903 ANDA ANDA078554 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0179-0159_81e118df-add9-4dde-8cfa-e6a7ef58cd69 0179-0159 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20140903 ANDA ANDA078554 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0179-0160_d578896f-5f36-4bac-8ee0-24cf67141252 0179-0160 HUMAN PRESCRIPTION DRUG Sildenafil sildenafil citrate TABLET, FILM COATED ORAL 20140919 NDA AUTHORIZED GENERIC NDA021845 KAISER FOUNDATION HOSPITALS SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0179-0161_1222336d-95b9-499c-bd78-04fd470597b9 0179-0161 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141027 ANDA ANDA200834 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0179-0162_1222336d-95b9-499c-bd78-04fd470597b9 0179-0162 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141027 ANDA ANDA200834 KAISER FOUNDATION HOSPITALS VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0179-0163_d25bf40a-dd3c-45d2-bfb0-7541ee7b324c 0179-0163 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20141107 ANDA ANDA071404 KAISER FOUNDATION HOSPITALS LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-0164_34410165-09ca-46bb-82d0-433b0fdf6e89 0179-0164 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20141111 ANDA ANDA074569 KAISER FOUNDATION HOSPITALS CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-0165_c803f04c-c4e0-4120-88e8-86a721323987 0179-0165 HUMAN PRESCRIPTION DRUG Bromocriptine Mesylate bromocriptine mesylate TABLET ORAL 20141010 ANDA ANDA076962 KAISER FOUNDATION HOSPITALS BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 0179-0166_86d22c23-5caf-4297-8658-1a6c223abe87 0179-0166 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20141010 NDA AUTHORIZED GENERIC NDA020796 KAISER FOUNDATION HOSPITALS ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0179-0167_7e2004b6-e4f7-48bf-b60a-bfb267bfdf89 0179-0167 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20141111 ANDA ANDA063083 KAISER FOUNDATION HOSPITALS CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0179-0169_3b8c2c45-828b-4ed3-ba08-042665c94f1c 0179-0169 HUMAN PRESCRIPTION DRUG Letrozole letrozole TABLET, FILM COATED ORAL 20150205 ANDA ANDA090934 KAISER FOUNDATION HOSPITALS LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0179-0172_38a5e06a-2750-43d2-8edc-4985cb879a0a 0179-0172 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20150320 ANDA ANDA203260 KAISER FOUNDATION HOSPITALS LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0179-0173_8ec252ce-cc6a-4bc1-8bde-bb8b39f35dc7 0179-0173 HUMAN PRESCRIPTION DRUG dicyclomine hydrochloride dicyclomine hydrochloride SOLUTION ORAL 20150402 ANDA ANDA040169 KAISER FOUNDATION HOSPITALS DICYCLOMINE HYDROCHLORIDE 10 mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0179-0174_d2f2275d-9c55-4dcd-9ab3-2c08ad574e1d 0179-0174 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20150407 NDA AUTHORIZED GENERIC NDA007073 KAISER FOUNDATION HOSPITALS SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0179-0175_16996dc4-3e74-4e42-bbee-910109aa9e51 0179-0175 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20150526 ANDA ANDA090061 KAISER FOUNDATION HOSPITALS FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 0179-0176_40a68ffc-e408-4f56-ad1e-8ad8adba828d 0179-0176 HUMAN OTC DRUG TUMS calcium carbonate TABLET ORAL 20150528 OTC MONOGRAPH FINAL part331 KAISER FOUNDATION HOSPITALS CALCIUM CARBONATE 500 mg/1 N 20181231 0179-0177_616f3b82-5761-48eb-8365-299912fce052 0179-0177 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20150604 ANDA ANDA086989 KAISER FOUNDATION HOSPITALS METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0179-0178_1b37fc6e-fe7f-4bad-8ec7-2f8248b31b10 0179-0178 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20150707 ANDA ANDA077095 KAISER FOUNDATION HOSPITALS METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0179-0179_d2d3bb77-3446-4f86-985b-5276f1cb813e 0179-0179 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20150709 ANDA ANDA077927 KAISER FOUNDATION HOSPITALS MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0179-0180_d2d3bb77-3446-4f86-985b-5276f1cb813e 0179-0180 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20150709 ANDA ANDA077927 KAISER FOUNDATION HOSPITALS MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0179-0183_1b37fc6e-fe7f-4bad-8ec7-2f8248b31b10 0179-0183 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20150707 ANDA ANDA077095 KAISER FOUNDATION HOSPITALS METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0179-0184_2b02a3e0-afff-41c8-b940-57c702cf6d84 0179-0184 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20150915 ANDA ANDA076578 KAISER FOUNDATION HOSPITALS ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0179-0185_046ea673-bf0a-40e6-82ea-d638040b5140 0179-0185 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20150915 ANDA ANDA077754 KAISER FOUNDATION HOSPITALS LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-0186_046ea673-bf0a-40e6-82ea-d638040b5140 0179-0186 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20151123 ANDA ANDA077754 KAISER FOUNDATION HOSPITALS LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-0187_2cb798d5-1ac8-4976-9160-0fa9d017c13a 0179-0187 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20151014 ANDA ANDA076745 KAISER FOUNDATION HOSPITALS OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0179-0188_77a3c8e2-b5de-4dd0-8799-3d36fcb3e19e 0179-0188 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20151029 ANDA ANDA076558 KAISER FOUNDATION HOSPITALS CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0179-0189_941fcf63-3a20-4d99-aa81-87c32abca515 0179-0189 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20151110 ANDA ANDA077563 KAISER FOUNDATION HOSPITALS CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0179-0191_814f7fe3-a12d-4d75-8845-a5a6ecaf4d96 0179-0191 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20151204 ANDA ANDA040616 KAISER FOUNDATION HOSPITALS WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0179-0192_814f7fe3-a12d-4d75-8845-a5a6ecaf4d96 0179-0192 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20151204 ANDA ANDA040616 KAISER FOUNDATION HOSPITALS WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0179-0193_814f7fe3-a12d-4d75-8845-a5a6ecaf4d96 0179-0193 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20151204 ANDA ANDA040616 KAISER FOUNDATION HOSPITALS WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0179-0195_f606da74-7d68-471f-8510-5234a7a1ba8c 0179-0195 HUMAN PRESCRIPTION DRUG Capecitabine capecitabine TABLET, FILM COATED ORAL 20151202 ANDA ANDA090943 KAISER FOUNDATION HOSPITALS CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0179-0196_35a6583d-82ef-45ae-8e7f-811779be3ccd 0179-0196 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20151203 ANDA ANDA091174 KAISER FOUNDATION HOSPITALS CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0179-0197_35a6583d-82ef-45ae-8e7f-811779be3ccd 0179-0197 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20151203 ANDA ANDA091174 KAISER FOUNDATION HOSPITALS CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0179-0199_814f7fe3-a12d-4d75-8845-a5a6ecaf4d96 0179-0199 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20151204 ANDA ANDA040616 KAISER FOUNDATION HOSPITALS WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0179-0200_a77bdfa4-da53-4b30-9bef-6535f3f2db5f 0179-0200 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20151201 ANDA ANDA076958 KAISER FOUNDATION HOSPITALS LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0179-0201_1281b68e-ef6c-4724-8d4c-69fc01483140 0179-0201 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20151218 ANDA ANDA076278 KAISER FOUNDATION HOSPITALS FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 0179-0202_a77bdfa4-da53-4b30-9bef-6535f3f2db5f 0179-0202 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20160316 ANDA ANDA076958 KAISER FOUNDATION HOSPITALS LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0179-0203_a77bdfa4-da53-4b30-9bef-6535f3f2db5f 0179-0203 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20160316 ANDA ANDA076958 KAISER FOUNDATION HOSPITALS LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0179-0204_bdd6b8d6-cdf1-453b-ab9e-b174e51db654 0179-0204 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20160426 ANDA ANDA040833 KAISER FOUNDATION HOSPITALS ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 0179-0205_dbcbe96b-0dff-406a-b655-83578a688f72 0179-0205 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20160422 ANDA ANDA077270 KAISER FOUNDATION HOSPITALS GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0179-0206_8facf54f-8e6a-45f1-b1de-a3a9d8fedbaf 0179-0206 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20160425 ANDA ANDA076899 KAISER FOUNDATION HOSPITALS SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0179-0207_321b8b41-ff83-4a0f-9581-e67c75fba1fb 0179-0207 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20160422 ANDA ANDA076004 KAISER FOUNDATION HOSPITALS ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0179-0208_4610378a-16be-41f0-bf5f-8622c3886589 0179-0208 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20160629 ANDA ANDA090768 KAISER FOUNDATION HOSPITALS DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0179-0210_9c95e98d-6a95-43dc-b38c-e3031cd5e053 0179-0210 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160708 ANDA ANDA203245 KAISER FOUNDATION HOSPITALS AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0179-0211_9c95e98d-6a95-43dc-b38c-e3031cd5e053 0179-0211 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160708 ANDA ANDA203245 KAISER FOUNDATION HOSPITALS AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0179-0212_7259232c-3ea8-4aaa-83df-f2eb1d7cfa0e 0179-0212 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20160708 ANDA ANDA204310 KAISER FOUNDATION HOSPITALS RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0179-0213_9c95e98d-6a95-43dc-b38c-e3031cd5e053 0179-0213 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160708 ANDA ANDA203245 KAISER FOUNDATION HOSPITALS AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0179-0214_3239efd9-7d23-4ac4-87d7-fb7df36019e0 0179-0214 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160914 NDA AUTHORIZED GENERIC NDA020702 KAISER FOUNDATION HOSPITALS ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0179-0215_3239efd9-7d23-4ac4-87d7-fb7df36019e0 0179-0215 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160914 NDA AUTHORIZED GENERIC NDA020702 KAISER FOUNDATION HOSPITALS ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0179-0216_3239efd9-7d23-4ac4-87d7-fb7df36019e0 0179-0216 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160914 NDA AUTHORIZED GENERIC NDA020702 KAISER FOUNDATION HOSPITALS ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0179-0217_82e6ccac-4f4b-4663-9158-03922edcb985 0179-0217 HUMAN PRESCRIPTION DRUG Riluzole Riluzole TABLET ORAL 20160929 ANDA ANDA204048 KAISER FOUNDATION HOSPITALS RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] N 20181231 0179-0218_c7efaf76-8de6-47dc-8649-53248b0a3d93 0179-0218 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20160920 ANDA ANDA091667 KAISER FOUNDATION HOSPITALS MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 0179-0219_b44a4d36-38b2-44ee-8328-d1b95fbb3952 0179-0219 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20160928 ANDA ANDA076052 KAISER FOUNDATION HOSPITALS SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0179-0220_a5fa7d8d-d249-4f7b-b70d-faf976ff2026 0179-0220 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20161012 ANDA ANDA208206 KAISER FOUNDATION HOSPITALS RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0179-0221_3a56c433-0981-4822-8462-911d1e48b2ca 0179-0221 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20161129 ANDA ANDA077836 KAISER FOUNDATION HOSPITALS GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 0179-0223_7d967392-61bf-47ec-94c4-bcdb1c562ad2 0179-0223 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20170117 ANDA ANDA073553 KAISER FOUNDATION HOSPITALS NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0179-0224_c2ed44db-3334-4a0f-8725-ab7b2e95431d 0179-0224 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20170112 ANDA ANDA075797 KAISER FOUNDATION HOSPITALS TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0179-0225_d5f47f85-98b6-4c8c-a269-692101829a46 0179-0225 HUMAN PRESCRIPTION DRUG Bromocriptine mesylate Bromocriptine mesylate TABLET ORAL 20170214 ANDA ANDA077646 KAISER FOUNDATION HOSPITALS BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 0179-0226_da976778-fca5-43c4-b890-c5aa75d906d9 0179-0226 HUMAN PRESCRIPTION DRUG Carbidopa Carbidopa Tablets TABLET ORAL 20170214 NDA AUTHORIZED GENERIC NDA017830 KAISER FOUNDATION HOSPITALS CARBIDOPA 25 mg/1 N 20181231 0179-0227_e846661f-546c-4ae8-917f-b6ac6579d632 0179-0227 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone Acetate TABLET ORAL 20170301 ANDA ANDA091090 KAISER FOUNDATION HOSPITALS NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0179-0228_40ed1cc0-6844-49fd-b9db-65faae4a424d 0179-0228 HUMAN OTC DRUG Rugby Antacid Tablets TABLET, CHEWABLE ORAL 20170303 OTC MONOGRAPH FINAL part331 KAISER FOUNDATION HOSPITALS CALCIUM CARBONATE 500 mg/1 N 20181231 0179-0229_c2285ed7-9710-445e-84ba-b86522dce3a2 0179-0229 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET ORAL 20170901 ANDA ANDA204741 KAISER FOUNDATION HOSPITALS CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0179-0230_8d910a0d-d29b-46b5-b179-e11413191768 0179-0230 HUMAN PRESCRIPTION DRUG amiloride hydrocloride amiloride hydrocloride TABLET ORAL 20170907 NDA NDA018200 KAISER FOUNDATION HOSPITALS AMILORIDE HYDROCHLORIDE 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 0179-0231_a1145c65-3e5b-490e-bca0-88f99bd845fc 0179-0231 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate Tablet TABLET ORAL 20170908 ANDA ANDA075882 KAISER FOUNDATION HOSPITALS FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 0179-0232_49630613-6770-4e0a-8294-60ee5dbb26d3 0179-0232 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20171218 ANDA ANDA084363 KAISER FOUNDATION HOSPITALS TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 0179-0236_49930260-e165-49f6-a695-c712fcfc35e0 0179-0236 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate Sevelamer Carbonate TABLET, FILM COATED ORAL 20171218 NDA AUTHORIZED GENERIC NDA022127 KAISER FOUNDATION HOSPITALS SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0179-0237_c1e9ee89-80d8-425a-97f1-fab044433505 0179-0237 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20171220 ANDA ANDA040627 KAISER FOUNDATION HOSPITALS BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 0179-0276_32a7a6d3-83fc-48fd-980b-fcffcf5307e1 0179-0276 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 KAISER FOUNDATION HOSPITALS DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 0179-1118_704c68fb-5c1d-4ead-bbe1-65d72a2aae9c 0179-1118 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19871222 ANDA ANDA071523 KAISER FOUNDATION HOSPITALS TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 0179-1429_01bf0c1a-33f1-4ce4-949c-a9794a2843ef 0179-1429 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20020129 ANDA ANDA071321 KAISER FOUNDATION HOSPITALS DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-1431_01bf0c1a-33f1-4ce4-949c-a9794a2843ef 0179-1431 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20020129 ANDA ANDA071322 KAISER FOUNDATION HOSPITALS DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-1433_35f632b4-e364-4feb-9ae6-f6e39f0b2c5b 0179-1433 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110718 ANDA ANDA075636 KAISER FOUNDATION HOSPITALS LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0179-1434_35f632b4-e364-4feb-9ae6-f6e39f0b2c5b 0179-1434 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110718 ANDA ANDA075636 KAISER FOUNDATION HOSPITALS LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0179-1435_35f632b4-e364-4feb-9ae6-f6e39f0b2c5b 0179-1435 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110718 ANDA ANDA075636 KAISER FOUNDATION HOSPITALS LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0179-1449_40a68ffc-e408-4f56-ad1e-8ad8adba828d 0179-1449 HUMAN OTC DRUG TUMS calcium carbonate TABLET ORAL 20150528 OTC MONOGRAPH FINAL part331 KAISER FOUNDATION HOSPITALS CALCIUM CARBONATE 500 mg/1 N 20181231 0179-1470_931c59f1-1bf9-4b4a-8577-3a56fa59bd1c 0179-1470 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20030602 ANDA ANDA071638 KAISER FOUNDATION HOSPITALS TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-1471_bae2a6dd-5863-4b8e-886e-8b95af461a97 0179-1471 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20050216 ANDA ANDA075511 KAISER FOUNDATION HOSPITALS FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0179-1482_f7ccb1b4-d47a-43f3-9ae9-aef5348f7917 0179-1482 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20031231 ANDA ANDA070033 KAISER FOUNDATION HOSPITALS METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0179-1497_b0ff09b3-7e53-46a3-a270-639513e8ed2a 0179-1497 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20150113 ANDA ANDA075074 KAISER FOUNDATION HOSPITALS ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0179-1579_b0ff09b3-7e53-46a3-a270-639513e8ed2a 0179-1579 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20051201 ANDA ANDA075078 KAISER FOUNDATION HOSPITALS ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0179-1804_455410ed-69b7-45c1-9400-92318ab5560d 0179-1804 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20060602 ANDA ANDA075410 KAISER FOUNDATION HOSPITALS OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0179-1838_e0f78c42-fdc4-4462-a444-3a5c1a01e5a2 0179-1838 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20060804 ANDA ANDA065062 KAISER FOUNDATION HOSPITALS MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0179-1847_94d77b3d-c23c-4a1b-bdc9-66fdb9372065 0179-1847 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone Acetate TABLET ORAL 20150219 ANDA ANDA075951 KAISER FOUNDATION HOSPITALS NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0179-1897_b44a4d36-38b2-44ee-8328-d1b95fbb3952 0179-1897 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20160928 ANDA ANDA076052 KAISER FOUNDATION HOSPITALS SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0179-1898_b44a4d36-38b2-44ee-8328-d1b95fbb3952 0179-1898 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20160928 ANDA ANDA076052 KAISER FOUNDATION HOSPITALS SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0179-1899_b44a4d36-38b2-44ee-8328-d1b95fbb3952 0179-1899 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20160928 ANDA ANDA076052 KAISER FOUNDATION HOSPITALS SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0179-1952_089a379c-072b-49a6-af3f-15ff33b3188c 0179-1952 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA075797 KAISER FOUNDATION HOSPITALS TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0179-1964_713b8b32-8f7c-49cb-9f7f-ff3b754bfaba 0179-1964 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080714 ANDA ANDA074112 KAISER FOUNDATION HOSPITALS ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-1965_713b8b32-8f7c-49cb-9f7f-ff3b754bfaba 0179-1965 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080714 ANDA ANDA074112 KAISER FOUNDATION HOSPITALS ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0179-1969_6ded2df8-302e-43ee-bc74-bfcd54783fdf 0179-1969 HUMAN PRESCRIPTION DRUG amlodipine besylate AMLODIPINE BESYLATE TABLET ORAL 20081021 NDA AUTHORIZED GENERIC NDA019787 KAISER FOUNDATION HOSPITALS AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0179-1970_6ded2df8-302e-43ee-bc74-bfcd54783fdf 0179-1970 HUMAN PRESCRIPTION DRUG amlodipine besylate AMLODIPINE BESYLATE TABLET ORAL 20081021 NDA AUTHORIZED GENERIC NDA019787 KAISER FOUNDATION HOSPITALS AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0179-1971_c8056e90-b589-4d6f-82e3-44362afb1a48 0179-1971 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20080802 ANDA ANDA040489 KAISER FOUNDATION HOSPITALS METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0179-1973_6ded2df8-302e-43ee-bc74-bfcd54783fdf 0179-1973 HUMAN PRESCRIPTION DRUG amlodipine besylate AMLODIPINE BESYLATE TABLET ORAL 20081021 NDA AUTHORIZED GENERIC NDA019787 KAISER FOUNDATION HOSPITALS AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0179-1978_e06da151-5168-405d-94e7-2d89737530fc 0179-1978 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20081020 ANDA ANDA078250 KAISER FOUNDATION HOSPITALS NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0179-1979_1b37fc6e-fe7f-4bad-8ec7-2f8248b31b10 0179-1979 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20150707 ANDA ANDA077095 KAISER FOUNDATION HOSPITALS METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0179-1980_d17524df-0382-480d-9892-0582c6ee93ab 0179-1980 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20081001 NDA NDA077322 KAISER FOUNDATION HOSPITALS ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0179-1981_d17524df-0382-480d-9892-0582c6ee93ab 0179-1981 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20081001 NDA NDA077322 KAISER FOUNDATION HOSPITALS ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0179-1982_34b7fb5d-113e-4fee-baa5-7b19c3f662e1 0179-1982 HUMAN PRESCRIPTION DRUG Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride TABLET ORAL 20110623 ANDA ANDA076089 KAISER FOUNDATION HOSPITALS CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0179-1984_10055ce4-847f-456b-949b-b8697a318d9f 0179-1984 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20081103 ANDA ANDA077321 KAISER FOUNDATION HOSPITALS LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0179-1985_10055ce4-847f-456b-949b-b8697a318d9f 0179-1985 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20081103 ANDA ANDA077321 KAISER FOUNDATION HOSPITALS LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0179-1988_10055ce4-847f-456b-949b-b8697a318d9f 0179-1988 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20081103 ANDA ANDA077321 KAISER FOUNDATION HOSPITALS LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0179-1999_b65e5b04-1697-4966-af0d-fde008a6869c 0179-1999 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20151014 ANDA ANDA040197 KAISER FOUNDATION HOSPITALS ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0179-8012_f31aa13f-2536-4815-b365-899cff4d78a0 0179-8012 HUMAN OTC DRUG KAISER PERMANENTE Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Kaiser Foundation Hospitals BACITRACIN ZINC 500 [iU]/g N 20181231 0179-8014_8e606bce-9248-4f9e-bfdf-e187b2a5053f 0179-8014 HUMAN OTC DRUG Clotrimazole Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Kaiser Foundation Hospitals CLOTRIMAZOLE 10 mg/g N 20181231 0179-8016_80d79abf-cabf-4cd6-9005-a4f272a4f42c 0179-8016 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20010913 OTC MONOGRAPH NOT FINAL part348 Kaiser Foundation Hospitals HYDROCORTISONE .5 g/100g N 20181231 0179-8017_9d126a09-ab43-43b0-beaa-face4202b702 0179-8017 HUMAN OTC DRUG Kaiser Permanente Miconazole Nitrate Miconazole Nitrate CREAM TOPICAL 19911001 OTC MONOGRAPH FINAL part333C Kaiser Foundation Hospitals MICONAZOLE NITRATE 20 mg/g N 20181231 0179-8019_de5605f4-f404-45df-906f-29484ce60bed 0179-8019 HUMAN OTC DRUG Kaiser Permanente Tolnaftate Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Kaiser Foundations Hospitals TOLNAFTATE 10 mg/g N 20181231 0179-8068_f12647ec-d640-85c1-550c-4900741e06f1 0179-8068 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160610 ANDA ANDA208150 Kaiser Foundation Hospitals FLUTICASONE PROPIONATE 50 ug/1 N 20181231 0179-8104_29e305ec-33f6-35ae-7760-6156299c3134 0179-8104 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20160101 ANDA ANDA078878 Kaiser Permanente OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 0179-8301_0f725624-ce3b-493c-9045-40162d7f4e11 0179-8301 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20131213 ANDA ANDA077829 Kaiser Foundation Hospitals CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 0179-8302_2e88539e-c12a-4e2d-b945-2942dfb0f07c 0179-8302 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20131213 ANDA ANDA077829 Kaiser Foundation Hospitals CETIRIZINE HYDROCHLORIDE 5 mg/1 E 20171231 0179-8317_ba205a3b-7606-4696-b613-52c6b5659d16 0179-8317 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20110223 ANDA ANDA076134 Kaiser Foundation Hospitals LORATADINE 10 mg/1 N 20181231 0179-8325_1fc8ee41-792d-ca7b-75b6-c2b385765f93 0179-8325 HUMAN OTC DRUG Fexofenadine Hydrochloride 180 Fexofenadine Hydrochloride TABLET ORAL 20120705 ANDA ANDA076502 Kaiser Permanente FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 0179-8601_cf8dd0ed-1687-43eb-bfca-d778a3ca24dd 0179-8601 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20111108 ANDA ANDA077958 KAISER FOUNDATION HOSPITALS KETOTIFEN FUMARATE .35 mg/mL N 20181231 0179-8702_1f8452ab-d273-4e0d-9f8b-596c544cd9e2 0179-8702 HUMAN OTC DRUG kaiser permanente benzoyl peroxide BENZOYL PEROXIDE GEL TOPICAL 20070608 OTC MONOGRAPH FINAL part333D Kaiser Foundation Hospitals BENZOYL PEROXIDE 5 g/100g N 20181231 0179-8703_50a228c7-27a8-4d7a-bc93-a562b44a0509 0179-8703 HUMAN OTC DRUG kaiser permanente benzoyl peroxide BENZOYL PEROXIDE GEL TOPICAL 20070608 OTC MONOGRAPH FINAL part333D Kaiser Foundation Hospitals BENZOYL PEROXIDE 10 g/100g N 20181231 0179-8704_60baf897-22d4-4518-8717-e1b3d12290ab 0179-8704 HUMAN OTC DRUG kaiser permanente benzoyl peroxide BENZOYL PEROXIDE SUSPENSION TOPICAL 20070608 OTC MONOGRAPH FINAL part333D Kaiser Foundation Hospitals BENZOYL PEROXIDE 10 g/100g N 20181231 0179-8705_a5d67372-15f9-4c02-82eb-3016771339b3 0179-8705 HUMAN OTC DRUG kaiser permanente benzoyl peroxide BENZOYL PEROXIDE LIQUID TOPICAL 20070608 OTC MONOGRAPH FINAL part333D Kaiser Foundation Hospitals BENZOYL PEROXIDE 5 g/100g N 20181231 0179-8707_567aaa53-2b89-40cc-b881-e653ca2b8bb2 0179-8707 HUMAN OTC DRUG Kaiser Permanente Double antibiotic Bacitracin zinc and Polymyxin B sulfate OINTMENT TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Kaiser Foundations Hospitals BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 0179-8710_4ba36b39-12c4-4f96-a8ca-761d70d90ee6 0179-8710 HUMAN OTC DRUG KAISER PERMANENTE Hydrocortisone Hydrocortisone acetate CREAM TOPICAL 20010601 OTC MONOGRAPH NOT FINAL part348 Kaiser Foundation Hospitals HYDROCORTISONE ACETATE 1 g/100g N 20181231 0179-8711_4986e78a-ac51-461b-a8ea-d49bc4b26331 0179-8711 HUMAN OTC DRUG KAISER PERMANENTE Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Kaiser Foundation Hospitals HYDROCORTISONE 1 g/100g N 20181231 0179-8715_657d8ac9-5eec-433a-ab09-04e279800d29 0179-8715 HUMAN OTC DRUG KAISER PERMANENTE Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Kaiser Foundation Hospitals TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 0185-0010_5935b0eb-4384-4bd6-a652-74f8f0c3ab31 0185-0010 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 19980804 ANDA ANDA075113 Eon Labs, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0185-0017_5e75a2ef-3f32-4d97-8660-d20c6b0356cf 0185-0017 HUMAN PRESCRIPTION DRUG fluvoxamine maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20001129 ANDA ANDA075888 Eon Labs, Inc. FLUVOXAMINE MALEATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0185-0020_d423d909-f428-4514-9814-e0a6b94de27a 0185-0020 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076219 Eon Labs, Inc. MIRTAZAPINE 15 mg/1 N 20181231 0185-0022_a5096455-c746-4a14-94fd-9209f86e773b 0185-0022 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 20000215 ANDA ANDA040327 Eon Labs, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 0185-0027_5e75a2ef-3f32-4d97-8660-d20c6b0356cf 0185-0027 HUMAN PRESCRIPTION DRUG fluvoxamine maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20001129 ANDA ANDA075888 Eon Labs, Inc. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0185-0034_773d1da9-3b64-4f69-b7e5-0315d6fa3ccf 0185-0034 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20021126 ANDA ANDA076280 Eon Labs, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0185-0040_0f19113b-5a11-4514-9b22-5b19fed1c08d 0185-0040 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20030911 ANDA ANDA076514 Eon Labs, Inc. MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0185-0041_2fea746d-9480-455d-a2e0-8ec35fafe736 0185-0041 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Eon Labs, Inc. FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0185-0042_2fea746d-9480-455d-a2e0-8ec35fafe736 0185-0042 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Eon Labs, Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0185-0043_0f19113b-5a11-4514-9b22-5b19fed1c08d 0185-0043 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20030911 ANDA ANDA076514 Eon Labs, Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0185-0047_2fea746d-9480-455d-a2e0-8ec35fafe736 0185-0047 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Eon Labs, Inc. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0185-0053_43f05c06-c55a-46bf-8018-4317f6b12e44 0185-0053 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0185-0055_a75a7b62-e163-4a4f-adc2-2db73f429239 0185-0055 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20031219 ANDA ANDA076466 Eon Labs, Inc. METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0185-0063_34590288-70fe-4e83-a00e-bf45146b0db7 0185-0063 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 Eon Labs, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0185-0064_34590288-70fe-4e83-a00e-bf45146b0db7 0185-0064 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 Eon Labs, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0185-0065_34590288-70fe-4e83-a00e-bf45146b0db7 0185-0065 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 Eon Labs, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0185-0070_d5bdceef-2476-44eb-bbe8-80d6226e23d0 0185-0070 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Eon Labs, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0185-0072_d5bdceef-2476-44eb-bbe8-80d6226e23d0 0185-0072 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Eon Labs, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0185-0074_d5bdceef-2476-44eb-bbe8-80d6226e23d0 0185-0074 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Eon Labs, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0185-0084_9cc3fec2-8210-42ba-9d0e-3828e8c176fb 0185-0084 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020927 20190630 ANDA ANDA040439 Eon Labs, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0185-0111_9cc3fec2-8210-42ba-9d0e-3828e8c176fb 0185-0111 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020614 20190630 ANDA ANDA040439 Eon Labs, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0185-0115_69bb6c03-a786-4ced-9d02-ee541657f376 0185-0115 HUMAN PRESCRIPTION DRUG Ticlopidine Hydrochloride Ticlopidine Hydrochloride TABLET, FILM COATED ORAL 19990820 ANDA ANDA075326 Eon Labs, Inc. TICLOPIDINE HYDROCHLORIDE 250 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 0185-0117_5935b0eb-4384-4bd6-a652-74f8f0c3ab31 0185-0117 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 19980804 ANDA ANDA075113 Eon Labs, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0185-0118_5935b0eb-4384-4bd6-a652-74f8f0c3ab31 0185-0118 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 19980804 ANDA ANDA075113 Eon Labs, Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0185-0122_d917ed51-4587-48f4-b389-ded961eca1a0 0185-0122 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 20050406 ANDA ANDA077066 Eon Labs, Inc. NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0185-0123_84fc9a33-42c5-4700-891c-4f7923b93ebf 0185-0123 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20051108 ANDA ANDA077310 Eon Labs, Inc. CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0185-0128_45f629a4-1653-434f-9b46-71d5a7dd5112 0185-0128 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 Eon Labs, Inc. BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0185-0129_45f629a4-1653-434f-9b46-71d5a7dd5112 0185-0129 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 Eon Labs, Inc. BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0185-0130_45f629a4-1653-434f-9b46-71d5a7dd5112 0185-0130 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 Eon Labs, Inc. BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0185-0141_17262661-cdae-4e32-97fa-07e436a44202 0185-0141 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20010131 ANDA ANDA075845 Eon Labs, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0185-0144_d04725b9-80f9-489d-89e9-9e36898d57a8 0185-0144 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 19981223 ANDA ANDA075315 Eon Labs, Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0185-0145_f4021735-068e-4931-b515-af34a00b665b 0185-0145 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20020225 ANDA ANDA075280 Eon Labs, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0185-0146_f4021735-068e-4931-b515-af34a00b665b 0185-0146 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20020225 ANDA ANDA075280 Eon Labs, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0185-0149_0f19113b-5a11-4514-9b22-5b19fed1c08d 0185-0149 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20020702 ANDA ANDA076514 Eon Labs, Inc. MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0185-0150_feddbd41-0f92-4fa6-b134-505a802bb541 0185-0150 HUMAN PRESCRIPTION DRUG nizatidine nizatidine CAPSULE ORAL 20020705 ANDA ANDA076178 Eon Labs, Inc. NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0185-0152_b46e030c-a23b-4029-95c2-9c76d09873ef 0185-0152 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020702 ANDA ANDA076262 Eon Labs, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0185-0157_5e75a2ef-3f32-4d97-8660-d20c6b0356cf 0185-0157 HUMAN PRESCRIPTION DRUG fluvoxamine maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20001129 ANDA ANDA075888 Eon Labs, Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0185-0170_401b80f7-8916-4421-be5f-e0647f553c88 0185-0170 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20000501 ANDA ANDA075366 Eon Labs, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0185-0171_401b80f7-8916-4421-be5f-e0647f553c88 0185-0171 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20000501 ANDA ANDA075366 Eon Labs, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0185-0173_b46e030c-a23b-4029-95c2-9c76d09873ef 0185-0173 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA076262 Eon Labs, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0185-0174_401b80f7-8916-4421-be5f-e0647f553c88 0185-0174 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20000501 ANDA ANDA075366 Eon Labs, Inc. SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0185-0177_401b80f7-8916-4421-be5f-e0647f553c88 0185-0177 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20000501 ANDA ANDA075366 Eon Labs, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0185-0193_7e7898d4-7d5a-44cd-9087-9445695ded53 0185-0193 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077644 Eon Labs, Inc. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0185-0199_7e7898d4-7d5a-44cd-9087-9445695ded53 0185-0199 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077644 Eon Labs, Inc. ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0185-0200_7e7898d4-7d5a-44cd-9087-9445695ded53 0185-0200 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077644 Eon Labs, Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0185-0205_d056a9de-9634-4eef-940c-8c6f92ece34e 0185-0205 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20010327 ANDA ANDA040411 Eon Labs, Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 0185-0210_d056a9de-9634-4eef-940c-8c6f92ece34e 0185-0210 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20010327 ANDA ANDA040411 Eon Labs, Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 0185-0211_3af90ce5-5e88-4e3a-a36e-5cef852752d6 0185-0211 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 0185-0212_d423d909-f428-4514-9814-e0a6b94de27a 0185-0212 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076219 Eon Labs, Inc. MIRTAZAPINE 30 mg/1 N 20181231 0185-0213_0a0bb8b4-6322-499b-a201-e682a79641a7 0185-0213 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20020125 ANDA ANDA075965 Eon Labs, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0185-0215_0a0bb8b4-6322-499b-a201-e682a79641a7 0185-0215 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20020125 ANDA ANDA075965 Eon Labs, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0185-0221_0a0bb8b4-6322-499b-a201-e682a79641a7 0185-0221 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20020125 ANDA ANDA075965 Eon Labs, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0185-0222_d423d909-f428-4514-9814-e0a6b94de27a 0185-0222 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076219 Eon Labs, Inc. MIRTAZAPINE 45 mg/1 N 20181231 0185-0223_84fc9a33-42c5-4700-891c-4f7923b93ebf 0185-0223 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20041123 ANDA ANDA077021 Eon Labs, Inc. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0185-0236_3af90ce5-5e88-4e3a-a36e-5cef852752d6 0185-0236 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150317 ANDA ANDA076631 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 0185-0277_3af90ce5-5e88-4e3a-a36e-5cef852752d6 0185-0277 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 0185-0300_feddbd41-0f92-4fa6-b134-505a802bb541 0185-0300 HUMAN PRESCRIPTION DRUG nizatidine nizatidine CAPSULE ORAL 20020705 ANDA ANDA076178 Eon Labs, Inc. NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0185-0325_3af90ce5-5e88-4e3a-a36e-5cef852752d6 0185-0325 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20140404 ANDA ANDA076631 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 0185-0341_b6f13892-4715-48bc-8872-33747b336221 0185-0341 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20050928 ANDA ANDA076961 Eon Labs, Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0185-0342_b6f13892-4715-48bc-8872-33747b336221 0185-0342 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20050928 ANDA ANDA076961 Eon Labs, Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0185-0371_7135ba86-24ce-4783-aebd-1768afcb40a0 0185-0371 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Eon Labs, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0185-0372_7135ba86-24ce-4783-aebd-1768afcb40a0 0185-0372 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Eon Labs, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0185-0373_7135ba86-24ce-4783-aebd-1768afcb40a0 0185-0373 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Eon Labs, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0185-0401_9cc3fec2-8210-42ba-9d0e-3828e8c176fb 0185-0401 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020614 20190630 ANDA ANDA040439 Eon Labs, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0185-0404_9cc3fec2-8210-42ba-9d0e-3828e8c176fb 0185-0404 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020614 20190630 ANDA ANDA040439 Eon Labs, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0185-0410_ef6a316d-6e86-41a6-9aad-dfd136c02038 0185-0410 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20031125 ANDA ANDA075932 Eon Labs, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 0185-0415_ef6a316d-6e86-41a6-9aad-dfd136c02038 0185-0415 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040322 ANDA ANDA075932 Eon Labs, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 0185-0448_121351f1-90b2-41a9-8138-85e7a5e3c0c1 0185-0448 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20100331 ANDA ANDA040445 Eon Labs, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 0185-0505_43f05c06-c55a-46bf-8018-4317f6b12e44 0185-0505 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0185-0550_2f555b8f-6aca-4365-93f6-382984a1848d 0185-0550 HUMAN PRESCRIPTION DRUG itraconazole itraconazole CAPSULE ORAL 20040528 ANDA ANDA076104 Eon Labs, Inc. ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0185-0602_bf92a083-c415-492b-bbca-36dca3682a83 0185-0602 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20151221 ANDA ANDA075994 Eon Labs, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0185-0605_beb2223e-1f83-49dd-9eed-9c359aa7c62d 0185-0605 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20170118 ANDA ANDA075994 Eon Labs, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0185-0610_bf92a083-c415-492b-bbca-36dca3682a83 0185-0610 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150521 ANDA ANDA075994 Eon Labs, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0185-0613_2ff7e14b-1549-4218-acd1-1804984c0d9d 0185-0613 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 20190410 ANDA ANDA087479 Eon Labs, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20191231 0185-0615_2ff7e14b-1549-4218-acd1-1804984c0d9d 0185-0615 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 Eon Labs, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20191231 0185-0620_bf92a083-c415-492b-bbca-36dca3682a83 0185-0620 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150523 ANDA ANDA075994 Eon Labs, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0185-0630_bf92a083-c415-492b-bbca-36dca3682a83 0185-0630 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150819 ANDA ANDA075994 Eon Labs, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0185-0640_bf92a083-c415-492b-bbca-36dca3682a83 0185-0640 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150609 ANDA ANDA075994 Eon Labs, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0185-0644_320e3d48-6bee-423c-a811-be0a73a01d51 0185-0644 HUMAN PRESCRIPTION DRUG phentermine hydrochloride phentermine hydrochloride CAPSULE ORAL 19810612 ANDA ANDA087190 Eon Labs, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0185-0647_320e3d48-6bee-423c-a811-be0a73a01d51 0185-0647 HUMAN PRESCRIPTION DRUG phentermine hydrochloride phentermine hydrochloride CAPSULE ORAL 19810612 ANDA ANDA087190 Eon Labs, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0185-0648_6e186e80-dbf3-4c72-b85e-17d59b859dd8 0185-0648 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20000501 OTC MONOGRAPH FINAL part341 Eon Labs, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0185-0649_6e186e80-dbf3-4c72-b85e-17d59b859dd8 0185-0649 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20000501 OTC MONOGRAPH FINAL part341 Eon Labs, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 0185-0674_2ff7e14b-1549-4218-acd1-1804984c0d9d 0185-0674 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20140627 ANDA ANDA087479 Eon Labs, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20191231 0185-0675_dca29d5c-2146-4761-b6b6-c6c8acb86472 0185-0675 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 20150420 ANDA ANDA074903 Eon Labs, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0185-0687_dca29d5c-2146-4761-b6b6-c6c8acb86472 0185-0687 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 20150420 ANDA ANDA074903 Eon Labs, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0185-0701_9e881d2a-7d0f-48ec-8d35-921130c8a604 0185-0701 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Eon Labs, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0185-0704_9e881d2a-7d0f-48ec-8d35-921130c8a604 0185-0704 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Eon Labs, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0185-0707_9e881d2a-7d0f-48ec-8d35-921130c8a604 0185-0707 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Eon Labs, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0185-0720_ccac0b09-327e-45c3-90bd-13be1bf4e72d 0185-0720 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 19980528 ANDA ANDA074464 Eon Labs, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0185-0724_501b39a2-0b88-4277-89a1-45b61cdad1bf 0185-0724 HUMAN PRESCRIPTION DRUG Carisoprodol and Aspirin Carisoprodol and Aspirin TABLET ORAL 19960425 ANDA ANDA040116 Eon Labs, Inc. CARISOPRODOL; ASPIRIN 200; 325 mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE] CIV N 20181231 0185-0749_36663896-ea22-41aa-8d75-8de35e67e7ee 0185-0749 HUMAN PRESCRIPTION DRUG Carisoprodol, Aspirin and Codeine Phosphate Carisoprodol, Aspirin and Codeine Phosphate TABLET ORAL 19960416 20190930 ANDA ANDA040118 Eon Labs, Inc. CARISOPRODOL; ASPIRIN; CODEINE PHOSPHATE 200; 325; 16 mg/1; mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0185-0757_c6c135bd-ce00-46ce-b941-5fe596c36156 0185-0757 HUMAN PRESCRIPTION DRUG Sulfadiazine Sulfadiazine TABLET ORAL 19940729 ANDA ANDA040091 Eon Labs, Inc. SULFADIAZINE 500 mg/1 Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0185-0771_d930914a-33c5-4dca-bd75-5c489582c344 0185-0771 HUMAN PRESCRIPTION DRUG bisoprolol fumarate bisoprolol fumarate TABLET, COATED ORAL 20001116 ANDA ANDA075643 Eon Labs, Inc. BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0185-0774_d930914a-33c5-4dca-bd75-5c489582c344 0185-0774 HUMAN PRESCRIPTION DRUG bisoprolol fumarate bisoprolol fumarate TABLET, COATED ORAL 20001116 ANDA ANDA075643 Eon Labs, Inc. BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0185-0799_0b892acb-a0d5-4c55-b55b-87309184feb9 0185-0799 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 19970528 ANDA ANDA064150 Eon Labs, Inc. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 0185-0801_0b892acb-a0d5-4c55-b55b-87309184feb9 0185-0801 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 19980102 ANDA ANDA064150 Eon Labs, Inc. RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 0185-0820_43f05c06-c55a-46bf-8018-4317f6b12e44 0185-0820 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Eon Labs, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0185-0831_8605eaf2-567c-45a3-b5d3-d9646ae1f44b 0185-0831 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20160420 ANDA ANDA040439 Eon Labs, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0185-0842_8605eaf2-567c-45a3-b5d3-d9646ae1f44b 0185-0842 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20160420 ANDA ANDA040439 Eon Labs, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0185-0853_8605eaf2-567c-45a3-b5d3-d9646ae1f44b 0185-0853 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20160420 ANDA ANDA040439 Eon Labs, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0185-0864_8605eaf2-567c-45a3-b5d3-d9646ae1f44b 0185-0864 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20160420 ANDA ANDA040439 Eon Labs, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0185-0932_712d2ef2-c795-496a-b4c2-f3e30789dd01 0185-0932 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE ORAL 20000113 ANDA ANDA065017 Eon Labs, Inc. CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0185-0933_712d2ef2-c795-496a-b4c2-f3e30789dd01 0185-0933 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE ORAL 20000113 ANDA ANDA065017 Eon Labs, Inc. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0185-0939_f4da1f18-41d1-4e7c-80dd-2b927ee18e64 0185-0939 HUMAN PRESCRIPTION DRUG cholestyramine light cholestyramine light POWDER, FOR SUSPENSION ORAL 19941104 ANDA ANDA074558 Eon Labs, Inc. CHOLESTYRAMINE 4 g/5.7g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 0185-0940_024ace7a-edc1-4b04-891e-4e9f1a29b0f6 0185-0940 HUMAN PRESCRIPTION DRUG Cholestyramine Cholestyramine POWDER, FOR SUSPENSION ORAL 19960815 ANDA ANDA074557 Eon Labs, Inc. CHOLESTYRAMINE 4 g/9g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 0185-1047_907407f7-7457-47e0-84d1-cec05fdea1fc 0185-1047 HUMAN PRESCRIPTION DRUG Quinidine Sulfate Quinidine Sulfate TABLET ORAL 19830926 ANDA ANDA088072 Eon Labs, Inc. QUINIDINE SULFATE 300 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0185-1111_ef6a316d-6e86-41a6-9aad-dfd136c02038 0185-1111 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20050622 ANDA ANDA075932 Eon Labs, Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 0185-4057_3fdbc78d-101e-4c56-a01a-6abd0c9788ed 0185-4057 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 19970819 ANDA ANDA085588 Eon Labs, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 0185-4346_907407f7-7457-47e0-84d1-cec05fdea1fc 0185-4346 HUMAN PRESCRIPTION DRUG Quinidine Sulfate Quinidine Sulfate TABLET ORAL 19761124 ANDA ANDA088072 Eon Labs, Inc. QUINIDINE SULFATE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0185-4350_a754b160-6afe-4f5d-b512-ec8f0ea7d324 0185-4350 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19781211 NDA NDA008678 Eon Labs, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 0185-4351_a754b160-6afe-4f5d-b512-ec8f0ea7d324 0185-4351 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19781211 NDA NDA008678 Eon Labs, Inc. ISONIAZID 100 mg/1 Antimycobacterial [EPC] N 20181231 0185-4400_773d1da9-3b64-4f69-b7e5-0315d6fa3ccf 0185-4400 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20020627 ANDA ANDA076280 Eon Labs, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0185-4416_27e7132c-47f1-494f-b7b5-2e0bdb0d0d82 0185-4416 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20041214 ANDA ANDA076873 Eon Labs, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 0185-5000_320e3d48-6bee-423c-a811-be0a73a01d51 0185-5000 HUMAN PRESCRIPTION DRUG phentermine hydrochloride phentermine hydrochloride CAPSULE ORAL 19830720 ANDA ANDA086945 Eon Labs, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0185-5050_a75a7b62-e163-4a4f-adc2-2db73f429239 0185-5050 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20031219 ANDA ANDA076732 Eon Labs, Inc. METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0185-5254_2b1b340b-7b78-4eb8-990a-034926308415 0185-5254 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 Eon Labs, Inc. PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 0185-5368_71637e22-817b-459a-9f83-7d7d051a7a21 0185-5368 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20080801 ANDA ANDA078510 Eon Labs, Inc. EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0185-5369_71637e22-817b-459a-9f83-7d7d051a7a21 0185-5369 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20080801 ANDA ANDA078510 Eon Labs, Inc. EPLERENONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0185-5600_a75a7b62-e163-4a4f-adc2-2db73f429239 0185-5600 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20031219 ANDA ANDA076466 Eon Labs, Inc. METOLAZONE 10 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0185-7100_b46e030c-a23b-4029-95c2-9c76d09873ef 0185-7100 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA076262 Eon Labs, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0185-7322_033ee32c-9a53-4fdd-ac28-dddce389fb60 0185-7322 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate ipratropium bromide and albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20010321 NDA NDA020950 Eon Labs, Inc. IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 3 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 0185-7400_db12d309-92e5-47f0-84d7-aba74956f6e0 0185-7400 HUMAN PRESCRIPTION DRUG Leuprolide Acetate Leuprolide Acetate INJECTION, SOLUTION SUBCUTANEOUS 19980804 ANDA ANDA074728 Eon Labs, Inc. LEUPROLIDE ACETATE 1 mg/.2mL Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] N 20181231 0186-0004_fc5fcff7-83fd-43d7-b439-fbb93d13c345 0186-0004 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 AstraZeneca Pharmaceuticals LP CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0186-0008_fc5fcff7-83fd-43d7-b439-fbb93d13c345 0186-0008 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 AstraZeneca Pharmaceuticals LP CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0186-0016_fc5fcff7-83fd-43d7-b439-fbb93d13c345 0186-0016 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 AstraZeneca Pharmaceuticals LP CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0186-0032_fc5fcff7-83fd-43d7-b439-fbb93d13c345 0186-0032 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 AstraZeneca Pharmaceuticals LP CANDESARTAN CILEXETIL 32 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0186-0162_9096d8c3-0512-4876-b940-8c72bff85a54 0186-0162 HUMAN PRESCRIPTION DRUG ATACAND HCT Candesartan cilexetil and Hydrochlorothiazide TABLET ORAL 20000928 NDA NDA021093 AstraZeneca Pharmaceuticals LP CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0186-0322_9096d8c3-0512-4876-b940-8c72bff85a54 0186-0322 HUMAN PRESCRIPTION DRUG ATACAND HCT Candesartan cilexetil and Hydrochlorothiazide TABLET ORAL 20000928 NDA NDA021093 AstraZeneca Pharmaceuticals LP CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0186-0324_9096d8c3-0512-4876-b940-8c72bff85a54 0186-0324 HUMAN PRESCRIPTION DRUG ATACAND HCT Candesartan cilexetil Hydrochlorothiazide TABLET ORAL 20080902 NDA NDA021093 AstraZeneca Pharmaceuticals LP CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0186-0370_d53f2b51-a29c-40d0-9eba-669d58be8f4c 0186-0370 HUMAN PRESCRIPTION DRUG SYMBICORT Budesonide and Formoterol Fumarate Dihydrate AEROSOL RESPIRATORY (INHALATION) 20070529 NDA NDA021929 AstraZeneca Pharmaceuticals LP BUDESONIDE; FORMOTEROL FUMARATE 160; 4.5 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0186-0372_d53f2b51-a29c-40d0-9eba-669d58be8f4c 0186-0372 HUMAN PRESCRIPTION DRUG SYMBICORT Budesonide and Formoterol Fumarate Dihydrate AEROSOL RESPIRATORY (INHALATION) 20070529 NDA NDA021929 AstraZeneca Pharmaceuticals LP BUDESONIDE; FORMOTEROL FUMARATE 80; 4.5 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0186-0382_b45a0b7c-3eb0-49e1-b12c-c4dfb5e89245 0186-0382 HUMAN PRESCRIPTION DRUG Esomeprazole magnesium Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20171001 NDA AUTHORIZED GENERIC NDA021153 AstraZeneca Pharmaceuticals LP ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-0384_b45a0b7c-3eb0-49e1-b12c-c4dfb5e89245 0186-0384 HUMAN PRESCRIPTION DRUG Esomeprazole magnesium Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20171001 NDA AUTHORIZED GENERIC NDA021153 AstraZeneca Pharmaceuticals LP ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-0606_d08d4c87-f558-4868-8606-562b52820704 0186-0606 HUMAN PRESCRIPTION DRUG PRILOSEC Omeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 19951115 NDA NDA019810 AstraZeneca Pharmaceuticals LP OMEPRAZOLE MAGNESIUM 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-0610_d08d4c87-f558-4868-8606-562b52820704 0186-0610 HUMAN PRESCRIPTION DRUG PRILOSEC Omeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20020209 NDA NDA022056 AstraZeneca Pharmaceuticals LP OMEPRAZOLE MAGNESIUM 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-0625_d08d4c87-f558-4868-8606-562b52820704 0186-0625 HUMAN PRESCRIPTION DRUG PRILOSEC Omeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20020209 NDA NDA022056 AstraZeneca Pharmaceuticals LP OMEPRAZOLE MAGNESIUM 2.5 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-0702_3cd361d5-a775-41aa-b364-181ae29bd148 0186-0702 HUMAN PRESCRIPTION DRUG ENTOCORT EC Budesonide CAPSULE ORAL 20011002 20190131 NDA NDA021324 AstraZeneca Pharmaceuticals LP BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0186-0742_d08d4c87-f558-4868-8606-562b52820704 0186-0742 HUMAN PRESCRIPTION DRUG PRILOSEC Omeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 19901001 NDA NDA019810 AstraZeneca Pharmaceuticals LP OMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-0743_d08d4c87-f558-4868-8606-562b52820704 0186-0743 HUMAN PRESCRIPTION DRUG PRILOSEC Omeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 19980608 NDA NDA019810 AstraZeneca Pharmaceuticals LP OMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-0776_336d8857-17f0-48f3-8db8-240600f18953 0186-0776 HUMAN PRESCRIPTION DRUG BRILINTA Ticagrelor TABLET ORAL 20150904 NDA NDA022433 AstraZeneca Pharmaceuticals LP TICAGRELOR 60 mg/1 P2Y12 Platelet Inhibitor [EPC],Phenylalanine Hydroxylase Activators [MoA],Decreased Platelet Aggregation [PE],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0186-0777_336d8857-17f0-48f3-8db8-240600f18953 0186-0777 HUMAN PRESCRIPTION DRUG BRILINTA Ticagrelor TABLET ORAL 20110805 NDA NDA022433 AstraZeneca Pharmaceuticals LP TICAGRELOR 90 mg/1 P2Y12 Platelet Inhibitor [EPC],Phenylalanine Hydroxylase Activators [MoA],Decreased Platelet Aggregation [PE],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0186-0916_0976b6cb-eb9f-4e23-a939-83eae58d3f7c 0186-0916 HUMAN PRESCRIPTION DRUG PULMICORT FLEXHALER Budesonide AEROSOL, POWDER RESPIRATORY (INHALATION) 20070319 NDA NDA021949 AstraZeneca Pharmaceuticals LP BUDESONIDE 180 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0186-0917_0976b6cb-eb9f-4e23-a939-83eae58d3f7c 0186-0917 HUMAN PRESCRIPTION DRUG PULMICORT FLEXHALER Budesonide AEROSOL, POWDER RESPIRATORY (INHALATION) 20070319 NDA NDA021949 AstraZeneca Pharmaceuticals LP BUDESONIDE 90 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0186-1073_5c877428-ae8f-4485-8865-cc3d261d7da7 0186-1073 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SPRAY, METERED NASAL 20140513 20180228 NDA NDA020746 AstraZeneca Pharmaceuticals LP BUDESONIDE 32 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0186-1088_5c051e75-911a-415d-9e71-3beef88fac8b 0186-1088 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20010326 NDA NDA019962 AstraZeneca Pharmaceuticals LP METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0186-1090_5c051e75-911a-415d-9e71-3beef88fac8b 0186-1090 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 AstraZeneca Pharmaceuticals LP METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0186-1092_5c051e75-911a-415d-9e71-3beef88fac8b 0186-1092 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 AstraZeneca Pharmaceuticals LP METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0186-1094_5c051e75-911a-415d-9e71-3beef88fac8b 0186-1094 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 AstraZeneca Pharmaceuticals LP METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0186-1988_90a869dd-24a8-4bfb-81c4-8f9180809a0f 0186-1988 HUMAN PRESCRIPTION DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRATORY (INHALATION) 20000908 NDA NDA020929 AstraZeneca Pharmaceuticals LP BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0186-1989_90a869dd-24a8-4bfb-81c4-8f9180809a0f 0186-1989 HUMAN PRESCRIPTION DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRATORY (INHALATION) 20000908 NDA NDA020929 AstraZeneca Pharmaceuticals LP BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0186-1990_90a869dd-24a8-4bfb-81c4-8f9180809a0f 0186-1990 HUMAN PRESCRIPTION DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRATORY (INHALATION) 20070917 NDA NDA020929 AstraZeneca Pharmaceuticals LP BUDESONIDE 1 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0186-4010_52142b5f-7cee-4458-a943-aa9e7ab6138a 0186-4010 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20080707 NDA NDA022101 AstraZeneca Pharmaceuticals LP ESOMEPRAZOLE MAGNESIUM 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-4020_52142b5f-7cee-4458-a943-aa9e7ab6138a 0186-4020 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20070319 NDA NDA021957 AstraZeneca Pharmaceuticals LP ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-4025_52142b5f-7cee-4458-a943-aa9e7ab6138a 0186-4025 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20120601 NDA NDA021957 AstraZeneca Pharmaceuticals LP ESOMEPRAZOLE MAGNESIUM 2.5 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-4040_52142b5f-7cee-4458-a943-aa9e7ab6138a 0186-4040 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20070319 NDA NDA021957 AstraZeneca Pharmaceuticals LP ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-4050_52142b5f-7cee-4458-a943-aa9e7ab6138a 0186-4050 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20120601 NDA NDA021957 AstraZeneca Pharmaceuticals LP ESOMEPRAZOLE MAGNESIUM 5 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-5020_52142b5f-7cee-4458-a943-aa9e7ab6138a 0186-5020 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 AstraZeneca Pharmaceuticals LP ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-5040_52142b5f-7cee-4458-a943-aa9e7ab6138a 0186-5040 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 AstraZeneca Pharmaceuticals LP ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-6020_d8c73701-98e2-4ad4-9103-7cdbad12a852 0186-6020 HUMAN PRESCRIPTION DRUG NEXIUM I.V. Esomeprazole sodium INJECTION INTRAVENOUS 20050503 NDA NDA021689 AstraZeneca Pharmaceuticals LP ESOMEPRAZOLE SODIUM 20 mg/5mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0186-6040_d8c73701-98e2-4ad4-9103-7cdbad12a852 0186-6040 HUMAN PRESCRIPTION DRUG NEXIUM I.V. Esomeprazole sodium INJECTION INTRAVENOUS 20050503 NDA NDA021689 AstraZeneca Pharmaceuticals LP ESOMEPRAZOLE SODIUM 40 mg/5mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0187-0004_f5fb3c37-72ae-4dd7-bdf5-409351980ee0 0187-0004 HUMAN PRESCRIPTION DRUG Siliq Brodalumab INJECTION SUBCUTANEOUS 20170215 BLA BLA761032 Valeant Pharmaceuticals North America LLC BRODALUMAB 210 mg/1 Interleukin-17 Receptor A Antagonist [EPC],Interleukin 17 Receptor A Antagonists [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 0187-0007_475531fa-6496-4ab4-bb9b-54fd1fcb36ad 0187-0007 HUMAN PRESCRIPTION DRUG Virazole Ribavirin POWDER, FOR SOLUTION RESPIRATORY (INHALATION) 19860101 NDA NDA018859 Valeant Pharmaceuticals North America LLC RIBAVIRIN 6 g/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 0187-0010_5f4f6223-4d34-4b9c-b437-818d3f219202 0187-0010 HUMAN PRESCRIPTION DRUG Ammonul sodium phenylacetate and sodium benzoate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050217 NDA NDA020645 Valeant Pharmaceuticals North America LLC SODIUM PHENYLACETATE; SODIUM BENZOATE 100; 100 mg/mL; mg/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 0187-0011_4254014b-834f-4f04-9c5b-087ddc744c84 0187-0011 HUMAN PRESCRIPTION DRUG Iprivask desirudin KIT 20131231 NDA NDA021271 Valeant Pharmaceuticals North America LLC N 20191231 0187-0054_c60aecd2-eb62-4749-b259-be660a2439c8 0187-0054 HUMAN PRESCRIPTION DRUG TussiCaps hydrocodone polistirex and chlorpheniramine polistirex CAPSULE, EXTENDED RELEASE ORAL 20110902 ANDA ANDA077273 VALEANT PHARMACEUTICALS NORTH AMERICA LLC HYDROCODONE; CHLORPHENIRAMINE 5; 4 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII N 20181231 0187-0063_8e55074b-e941-4e80-8017-8b09155deafe 0187-0063 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20130501 NDA NDA017794 Valeant Pharmaceuticals North America LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0187-0064_8e55074b-e941-4e80-8017-8b09155deafe 0187-0064 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20130501 NDA NDA017794 Valeant Pharmaceuticals North America LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0187-0065_8e55074b-e941-4e80-8017-8b09155deafe 0187-0065 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20130501 NDA NDA017794 Valeant Pharmaceuticals North America LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0187-0108_c60aecd2-eb62-4749-b259-be660a2439c8 0187-0108 HUMAN PRESCRIPTION DRUG TussiCaps hydrocodone polistirex and chlorpheniramine polistirex CAPSULE, EXTENDED RELEASE ORAL 20110902 ANDA ANDA077273 VALEANT PHARMACEUTICALS NORTH AMERICA LLC HYDROCODONE; CHLORPHENIRAMINE 10; 8 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII N 20181231 0187-0140_5a3d349f-bc34-4e0b-98af-a88606d636d7 0187-0140 HUMAN PRESCRIPTION DRUG Vasotec Enalapril Maleate TABLET ORAL 19880726 NDA NDA018998 Valeant Pharmaceuticals North America LLC ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 0187-0141_5a3d349f-bc34-4e0b-98af-a88606d636d7 0187-0141 HUMAN PRESCRIPTION DRUG Vasotec Enalapril Maleate TABLET ORAL 19851224 NDA NDA018998 Valeant Pharmaceuticals North America LLC ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 0187-0142_5a3d349f-bc34-4e0b-98af-a88606d636d7 0187-0142 HUMAN PRESCRIPTION DRUG Vasotec Enalapril Maleate TABLET ORAL 19851224 NDA NDA018998 Valeant Pharmaceuticals North America LLC ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 0187-0143_5a3d349f-bc34-4e0b-98af-a88606d636d7 0187-0143 HUMAN PRESCRIPTION DRUG Vasotec Enalapril Maleate TABLET ORAL 19851224 NDA NDA018998 Valeant Pharmaceuticals North America LLC ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 0187-0146_9d921535-a7ec-4b09-b8b4-61a94a3f30c7 0187-0146 HUMAN PRESCRIPTION DRUG Vaseretic enalapril maleate and hydrochlorothiazide TABLET ORAL 19861031 NDA NDA019221 Valeant Pharmaceuticals North America LLC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0187-0152_78380fc1-ffef-4f89-9323-59250127b9ac 0187-0152 HUMAN PRESCRIPTION DRUG Isordil Titradose isosorbide dinitrate TABLET ORAL 20130401 NDA NDA012093 Valeant Pharmaceuticals North America LLC ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0187-0192_78380fc1-ffef-4f89-9323-59250127b9ac 0187-0192 HUMAN PRESCRIPTION DRUG Isordil Titradose isosorbide dinitrate TABLET ORAL 20130401 NDA NDA012093 Valeant Pharmaceuticals North America LLC ISOSORBIDE DINITRATE 40 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0187-0245_48b8331e-65e2-4b6a-b8cb-f19c93dfced1 0187-0245 HUMAN PRESCRIPTION DRUG Migranal dihydroergotamine mesylate SPRAY NASAL 19971208 NDA NDA020148 Valeant Pharmaceuticals North America LLC DIHYDROERGOTAMINE MESYLATE 4 mg/mL Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient] N 20181231 0187-0453_610b4af7-d74b-4e6f-ad01-e869b4352fbb 0187-0453 HUMAN PRESCRIPTION DRUG ZELAPAR SELEGILINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING ORAL 20060614 NDA NDA021479 Valeant Pharmaceuticals North America LLC SELEGILINE HYDROCHLORIDE 1.25 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 0187-0650_3882c95a-4bb1-438d-8316-06517316e351 0187-0650 HUMAN PRESCRIPTION DRUG Oxsoralen-Ultra Methoxsalen CAPSULE, LIQUID FILLED ORAL 19861030 NDA NDA019600 Valeant Pharmaceuticals North America LLC METHOXSALEN 10 mg/1 Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient] N 20181231 0187-0658_fadd543e-2f71-4f90-8fea-278836163b74 0187-0658 HUMAN PRESCRIPTION DRUG Diastat diazepam GEL RECTAL 19970729 NDA NDA020648 Valeant Pharmaceuticals North America LLC DIAZEPAM 10 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0187-0659_fadd543e-2f71-4f90-8fea-278836163b74 0187-0659 HUMAN PRESCRIPTION DRUG Diastat diazepam GEL RECTAL 19970729 NDA NDA020648 Valeant Pharmaceuticals North America LLC DIAZEPAM 20 mg/4mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0187-0730_26165825-7b0c-424e-ae72-47ddaa456232 0187-0730 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20030829 NDA NDA021515 Valeant Pharmaceuticals North America LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 0187-0731_26165825-7b0c-424e-ae72-47ddaa456232 0187-0731 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20030829 NDA NDA021515 Valeant Pharmaceuticals North America LLC BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 0187-0771_ebcc26af-4d59-415b-b8e2-3bb68eb7cc6a 0187-0771 HUMAN PRESCRIPTION DRUG Cardizem Diltiazem Hydrochloride TABLET, COATED ORAL 20101225 NDA NDA018602 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-0772_ebcc26af-4d59-415b-b8e2-3bb68eb7cc6a 0187-0772 HUMAN PRESCRIPTION DRUG Cardizem Diltiazem Hydrochloride TABLET, COATED ORAL 20101225 NDA NDA018602 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-0792_ebcc26af-4d59-415b-b8e2-3bb68eb7cc6a 0187-0792 HUMAN PRESCRIPTION DRUG Cardizem Diltiazem Hydrochloride TABLET, COATED ORAL 20101225 NDA NDA018602 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-0795_13bb002b-bee3-45d4-a0ad-b47212815a38 0187-0795 HUMAN PRESCRIPTION DRUG Cardizem CD diltiazem hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20010411 NDA NDA020062 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-0796_13bb002b-bee3-45d4-a0ad-b47212815a38 0187-0796 HUMAN PRESCRIPTION DRUG Cardizem CD diltiazem hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20010411 NDA NDA020062 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-0797_13bb002b-bee3-45d4-a0ad-b47212815a38 0187-0797 HUMAN PRESCRIPTION DRUG Cardizem CD diltiazem hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20010411 NDA NDA020062 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-0798_13bb002b-bee3-45d4-a0ad-b47212815a38 0187-0798 HUMAN PRESCRIPTION DRUG Cardizem CD diltiazem hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20010411 NDA NDA020062 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-0799_13bb002b-bee3-45d4-a0ad-b47212815a38 0187-0799 HUMAN PRESCRIPTION DRUG Cardizem CD diltiazem hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20010411 NDA NDA020062 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-0901_1e0ca8d6-04ec-478a-b4b1-f7e86083526e 0187-0901 HUMAN PRESCRIPTION DRUG Testred C-III MethylTESTOSTERone CAPSULE ORAL 19731203 20180430 ANDA ANDA083976 Valeant Pharmaceuticals North America LLC METHYLTESTOSTERONE 10 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20191231 0187-0902_e975fdec-b9b5-4a03-bde9-07df4612be75 0187-0902 HUMAN PRESCRIPTION DRUG Android MethylTESTOSTERone CAPSULE ORAL 19731203 20180430 ANDA ANDA083976 Valeant Pharmaceuticals North America LLC METHYLTESTOSTERONE 10 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20191231 0187-0938_7d1e956c-52b2-4629-949b-b2f5b562610e 0187-0938 HUMAN PRESCRIPTION DRUG Tasmar Tolcapone TABLET, FILM COATED ORAL 20040727 NDA NDA020697 Valeant Pharmaceuticals North America LLC TOLCAPONE 100 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0187-0993_67701906-29e9-4525-8ae5-0a4c197c3cc0 0187-0993 HUMAN PRESCRIPTION DRUG Zovirax acyclovir OINTMENT TOPICAL 19820329 NDA NDA018604 Valeant Pharmaceuticals North America LLC ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0187-0994_4a1d6fe3-50c8-480b-ba41-4551e136943c 0187-0994 HUMAN PRESCRIPTION DRUG Zovirax acyclovir CREAM TOPICAL 20021230 NDA NDA021478 Valeant Pharmaceuticals North America LLC ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0187-1365_b1c8c075-6fa4-426d-b937-ce5cbe112898 0187-1365 HUMAN OTC DRUG CeraVe AM BROAD SPECTRUM SUNSCREEN SPF 30 Homosalate, Meradimate, Octinoxate, Zinc Oxide, and Octocrylene LOTION TOPICAL 20150615 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC HOMOSALATE; MERADIMATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 100; 50; 50; 20; 63 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 0187-1496_35288b66-dbd8-434f-9042-5a0db8efd0b4 0187-1496 HUMAN PRESCRIPTION DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC 19861105 NDA NDA019463 Valeant Pharmaceuticals North America LLC TIMOLOL MALEATE 6.8 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0187-1498_35288b66-dbd8-434f-9042-5a0db8efd0b4 0187-1498 HUMAN PRESCRIPTION DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC 19861105 NDA NDA019463 Valeant Pharmaceuticals North America LLC TIMOLOL MALEATE 3.4 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0187-1610_07a0f16c-ec10-412e-bb8e-f70bb6766d4f 0187-1610 HUMAN OTC DRUG AcneFree Clear Skin Treatments 24 HOUR Acne Clearing System Benzoyl Peroxide KIT 20140625 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC N 20181231 0187-1611_ab40ff51-090a-4839-a3ee-ff05738fd358 0187-1611 HUMAN OTC DRUG AcneFree Clear Skin Treatments 24 HOUR Severe Acne Clearing System benzoyl peroxide KIT 20140625 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC N 20181231 0187-1612_d5693b98-6fb6-42f0-b01e-b5c2651d1420 0187-1612 HUMAN OTC DRUG AcneFree Sensitive 24 HOUR Acne Clearing System Benzoyl Peroxide KIT 20140911 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC E 20171231 0187-1613_aaffcf93-41f6-4602-a4e5-3d0f0850e107 0187-1613 HUMAN OTC DRUG AcneFree Oil-Free Acne Cleanser benzoyl peroxide LIQUID TOPICAL 20130101 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE 25 mg/mL N 20181231 0187-1616_e901c442-49c0-4132-af45-1f0abbe5d8c1 0187-1616 HUMAN OTC DRUG AcneFree Severe Terminator Maximum Strength benzoyl peroxide CREAM TOPICAL 20140915 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE 100 mg/g N 20181231 0187-1619_3268a857-838b-4492-84e4-386674303509 0187-1619 HUMAN OTC DRUG ACNEFREE THERAPEUTIC SULFUR MASK SULFUR CREAM TOPICAL 20140909 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SULFUR 35 g/g E 20171231 0187-1638_88d5ef8c-dee2-4ee3-a8b6-fa99da487c75 0187-1638 HUMAN OTC DRUG AcneFree Daily Skin Therapy Acne Wash salicylic acid LIQUID TOPICAL 20160204 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 2 g/100mL E 20171231 0187-1639_cbb05ffc-6836-4350-8340-51b7edc39ba4 0187-1639 HUMAN OTC DRUG AcneFree Daily Skin Therapy Acne Pads salicylic acid SOLUTION TOPICAL 20160129 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 20 mg/1 E 20171231 0187-1660_3935743c-4ece-42ad-a2c7-bb1cc4b4bf21 0187-1660 HUMAN OTC DRUG TheraSeal Dimethicone CREAM TOPICAL 20120101 OTC MONOGRAPH FINAL part347 Valeant Pharmaceuticals North America LLC DIMETHICONE 1.7 g/170.1g E 20171231 0187-1704_5681e71b-0f65-4c1f-ac37-ff0d2cbe502d 0187-1704 HUMAN PRESCRIPTION DRUG Mephyton phytonadione TABLET ORAL 20130319 NDA NDA010104 Valeant Pharmaceuticals North America LLC PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 0187-1950_1c87156d-4117-4570-a636-d3b7ed0d25b7 0187-1950 HUMAN OTC DRUG CeraVe Healing Petrolatum OINTMENT TOPICAL 20151102 OTC MONOGRAPH FINAL part347 Valeant Pharmaceuticals North America LLC PETROLATUM 46.5 g/100g N 20181231 0187-1970_5ed6ffe1-3acc-4c31-b315-9642d53e1a52 0187-1970 HUMAN OTC DRUG CeraVe Itch Relief Moisturizing pramoxine hydrochloride LOTION TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part348 VALEANT PHARMACEUTICALS NORTH AMERICA LLC PRAMOXINE HYDROCHLORIDE 1 mg/mL E 20171231 0187-1975_a4f3e54b-220c-48dc-8ef8-91d88c384bf9 0187-1975 HUMAN OTC DRUG CeraVe Itch Relief Moisturizing Cream pramoxine hydrochloride CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part348 VALEANT PHARMACEUTICALS NORTH AMERICA LLC PRAMOXINE HYDROCHLORIDE 10 mg/g E 20171231 0187-2045_0c7cffb8-cdd3-435a-a7ee-88874304e122 0187-2045 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-2046_0c7cffb8-cdd3-435a-a7ee-88874304e122 0187-2046 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-2047_0c7cffb8-cdd3-435a-a7ee-88874304e122 0187-2047 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-2048_0c7cffb8-cdd3-435a-a7ee-88874304e122 0187-2048 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-2049_0c7cffb8-cdd3-435a-a7ee-88874304e122 0187-2049 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-2050_0c7cffb8-cdd3-435a-a7ee-88874304e122 0187-2050 HUMAN PRESCRIPTION DRUG Cardizem LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101225 NDA NDA021392 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-2120_1573b87f-4dab-4a45-9cbb-9cbf9d8c7321 0187-2120 HUMAN PRESCRIPTION DRUG Syprine trientine hydrochloride CAPSULE ORAL 19851108 NDA NDA019194 Valeant Pharmaceuticals North America LLC TRIENTINE HYDROCHLORIDE 250 mg/1 Metal Chelating Activity [MoA],Metal Chelator [EPC] N 20181231 0187-2204_1605de81-ceeb-4472-9757-76000efa57af 0187-2204 HUMAN OTC DRUG CeraVe Sunscreen Broad Spectrum SPF 50 Body Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20121225 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC TITANIUM DIOXIDE; ZINC OXIDE 4.165; 3.995 g/85g; g/85g N 20181231 0187-2205_d6838b8e-1160-4287-a7fa-2a7c547a08fe 0187-2205 HUMAN OTC DRUG CeraVe Sunscreen Broad Spectrum SPF 50 Face Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20121225 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC TITANIUM DIOXIDE; ZINC OXIDE 2.744; 2.632 g/56g; g/56g N 20181231 0187-2208_10c601ae-b733-4eaa-8c1e-0bd35516d8da 0187-2208 HUMAN OTC DRUG CeraVe Sunscreen Broad Spectrum SPF 50 Titanium Dioxide, Zinc Oxide STICK TOPICAL 20121203 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC TITANIUM DIOXIDE; ZINC OXIDE .8; .63 g/13.32g; g/13.32g N 20181231 0187-2209_1d6f9808-48f8-4933-8e0d-63b57359c65b 0187-2209 HUMAN OTC DRUG CeraVe Sunscreen Broad Spectrum SPF 30 BODY Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC TITANIUM DIOXIDE; ZINC OXIDE 36.7; 35 mg/g; mg/g N 20181231 0187-2210_c1874f3c-a097-47d1-b7a7-cdd19d950cf5 0187-2210 HUMAN OTC DRUG CeraVe Sunscreen Broad Spectrum SPF 30 FACE Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC TITANIUM DIOXIDE; ZINC OXIDE 37; 35 mg/g; mg/g N 20181231 0187-2218_d4cdafaa-b6c5-4a9e-91fa-06c9deb58773 0187-2218 HUMAN OTC DRUG CeraVe Baby Moisturizing Dimethicone CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Valeant Pharmaceuticals North America LLC DIMETHICONE 12 mg/g N 20181231 0187-2219_a03f905f-fd20-464d-a382-053482cd3b92 0187-2219 HUMAN OTC DRUG CeraVe Baby Moisturizing dimethicone LOTION TOPICAL 20131201 OTC MONOGRAPH FINAL part347 Valeant Pharmaceuticals North America LLC DIMETHICONE 10 mg/mL N 20181231 0187-2224_3f9e3054-76cc-480d-a051-10222256f6ee 0187-2224 HUMAN OTC DRUG CeraVe Baby Sunscreen Broad Spectrum SPF 45 titanium dioxide and zinc oxide LOTION TOPICAL 20141101 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC TITANIUM DIOXIDE; ZINC OXIDE 74; 114 mg/g; mg/g N 20181231 0187-2486_73e4af00-a163-4f49-8956-e3b95ad47fdb 0187-2486 HUMAN OTC DRUG CeraVe Anti-Itch Hydrocortisone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part348 Valeant Pharmaceuticals North America LLC HYDROCORTISONE 10 mg/g E 20171231 0187-2487_0fce92d9-737f-4cfa-a00f-177e1d85e891 0187-2487 HUMAN OTC DRUG CeraVe Baby Healing Petrolatum OINTMENT TOPICAL 20161107 OTC MONOGRAPH FINAL part347 Valeant Pharmaceuticals North America LLC PETROLATUM 46.5 g/100g N 20181231 0187-2489_a150b8c0-a320-4adb-a43e-2e809a220e82 0187-2489 HUMAN OTC DRUG CeraVe Therapeutic Hand dimethicone CREAM TOPICAL 20120101 OTC MONOGRAPH FINAL part347 Valeant Pharmaceuticals North America LLC DIMETHICONE 10 mg/g E 20171231 0187-2490_b003d2dd-609e-4302-a935-abc786b40640 0187-2490 HUMAN OTC DRUG CeraVe Skin Renewing Day Cream with Broad Spectrum SPF 30 Sunscreen octinoxate and zinc oxide LOTION TOPICAL 20161107 OTC MONOGRAPH FINAL part352 Valeant Pharmaceuticals North America LLC OCTINOXATE; ZINC OXIDE 75; 105 mg/g; mg/g N 20181231 0187-2612_f39d4186-66da-4ea1-9874-3125d232da1a 0187-2612 HUMAN PRESCRIPTION DRUG TIAZAC EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA NDA020401 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-2613_f39d4186-66da-4ea1-9874-3125d232da1a 0187-2613 HUMAN PRESCRIPTION DRUG TIAZAC EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA NDA020401 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-2614_f39d4186-66da-4ea1-9874-3125d232da1a 0187-2614 HUMAN PRESCRIPTION DRUG TIAZAC EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA NDA020401 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-2615_f39d4186-66da-4ea1-9874-3125d232da1a 0187-2615 HUMAN PRESCRIPTION DRUG TIAZAC EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA NDA020401 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-2616_f39d4186-66da-4ea1-9874-3125d232da1a 0187-2616 HUMAN PRESCRIPTION DRUG TIAZAC EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA NDA020401 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-2617_f39d4186-66da-4ea1-9874-3125d232da1a 0187-2617 HUMAN PRESCRIPTION DRUG TIAZAC EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA NDA020401 Valeant Pharmaceuticals North America LLC DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0187-3010_a2ea02c7-59f0-41af-b4e6-8796b9ce7c39 0187-3010 HUMAN PRESCRIPTION DRUG Mestinon pyridostigmine bromide TABLET ORAL 19550406 NDA NDA009829 Valeant Pharmaceuticals North America LLC PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0187-3012_a2ea02c7-59f0-41af-b4e6-8796b9ce7c39 0187-3012 HUMAN PRESCRIPTION DRUG Mestinon pyridostigmine bromide SYRUP ORAL 19650125 NDA NDA015193 Valeant Pharmaceuticals North America LLC PYRIDOSTIGMINE BROMIDE 60 mg/5mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0187-3013_a2ea02c7-59f0-41af-b4e6-8796b9ce7c39 0187-3013 HUMAN PRESCRIPTION DRUG Mestinon pyridostigmine bromide TABLET, EXTENDED RELEASE ORAL 19590112 NDA NDA011665 Valeant Pharmaceuticals North America LLC PYRIDOSTIGMINE BROMIDE 180 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0187-3050_d32448e6-7394-4295-8de9-690d891349f7 0187-3050 HUMAN PRESCRIPTION DRUG ONEXTON Clindamycin Phosphate and Benzoyl Peroxide GEL TOPICAL 20141124 NDA NDA050819 Valeant Pharmaceuticals North America LLC CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE 10; 37.5 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0187-3204_4c5fc416-3f8a-444b-aba3-4bbe1a46a32f 0187-3204 HUMAN PRESCRIPTION DRUG Efudex Fluorouracil CREAM TOPICAL 19700729 NDA NDA016831 Valeant Pharmaceuticals North America LLC FLUOROURACIL 2 g/40g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0187-3554_05b203ca-cc44-4c48-87d8-9fda464da88a 0187-3554 HUMAN PRESCRIPTION DRUG ANCOBON Flucytosine CAPSULE ORAL 19711126 NDA NDA017001 Valeant Pharmaceuticals North America LLC FLUCYTOSINE 250 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20181231 0187-3555_05b203ca-cc44-4c48-87d8-9fda464da88a 0187-3555 HUMAN PRESCRIPTION DRUG ANCOBON Flucytosine CAPSULE ORAL 19711126 NDA NDA017001 Valeant Pharmaceuticals North America LLC FLUCYTOSINE 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20181231 0187-4100_0fbbaace-b922-44ba-86cb-1310ee6c4597 0187-4100 HUMAN PRESCRIPTION DRUG Librax Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 19660901 NDA NDA012750 Valeant Pharmaceuticals International CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] N 20181231 0187-4203_3ad95865-a77c-41da-b572-e5c0bb404c79 0187-4203 HUMAN PRESCRIPTION DRUG Opium Tincture Deodorized morphine SOLUTION ORAL 20080917 UNAPPROVED DRUG OTHER Valeant Pharmaceuticals North America LLC MORPHINE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0187-4220_d892a312-12ba-4d32-a840-2c0ff3dc1d58 0187-4220 HUMAN PRESCRIPTION DRUG Seconal Sodium secobarbital sodium CAPSULE ORAL 19831003 ANDA ANDA086101 Valeant Pharmaceuticals North America LLC SECOBARBITAL SODIUM 100 mg/1 CII N 20181231 0187-4302_fd76b793-d446-4d22-b905-aa981c0b5bf3 0187-4302 HUMAN PRESCRIPTION DRUG Nitropress sodium nitroprusside INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20131201 ANDA ANDA071961 Valeant Pharmaceuticals North America LLC SODIUM NITROPRUSSIDE 50 mg/2mL Vasodilation [PE],Vasodilator [EPC] N 20181231 0187-4303_94ba4d57-e4da-4080-9c8e-9e0065aef659 0187-4303 HUMAN PRESCRIPTION DRUG Amytal Sodium amobarbital sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080925 UNAPPROVED DRUG OTHER Valeant Pharmaceuticals North America LLC AMOBARBITAL SODIUM .5 g/5mL CII N 20181231 0187-4330_9b560894-45f2-4286-b9fd-8bfeb6c6a272 0187-4330 HUMAN PRESCRIPTION DRUG Isuprel Isoproterenol hydrochloride INJECTION, SOLUTION INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20131201 NDA NDA010515 Valeant Pharmaceuticals North America LLC ISOPROTERENOL HYDROCHLORIDE .2 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20181231 0187-4420_6ebea066-d98c-46bf-9444-0f54ac4b2ed9 0187-4420 HUMAN PRESCRIPTION DRUG Pepcid famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075805 Valeant Pharmaceuticals North America LLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0187-4440_6ebea066-d98c-46bf-9444-0f54ac4b2ed9 0187-4440 HUMAN PRESCRIPTION DRUG Pepcid famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075805 Valeant Pharmaceuticals North America LLC FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0187-5010_387c6f97-65d1-4cc9-9b5b-639bdd1fa339 0187-5010 HUMAN OTC DRUG AcneFree Body Clearing Salicylic Acid SPRAY TOPICAL 20140114 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 2.84 g/142g N 20181231 0187-5012_f65e2cb5-930e-4782-841d-17ed3f99a2dc 0187-5012 HUMAN OTC DRUG AcneFree Clear Skin Treatments Advanced Deep Cleansing Duo benzoyl peroxide KIT 20140625 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC E 20171231 0187-5100_6ce615d6-ec6c-48cf-b3f7-d43ddabc6731 0187-5100 HUMAN PRESCRIPTION DRUG ELIDEL Pimecrolimus CREAM TOPICAL 20011202 NDA NDA021302 Valeant Pharmaceuticals North America LLC PIMECROLIMUS 10 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 0187-5101_6ce615d6-ec6c-48cf-b3f7-d43ddabc6731 0187-5101 HUMAN PRESCRIPTION DRUG ELIDEL Pimecrolimus CREAM TOPICAL 20011202 NDA NDA021302 Valeant Pharmaceuticals North America LLC PIMECROLIMUS 10 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 0187-5102_6ce615d6-ec6c-48cf-b3f7-d43ddabc6731 0187-5102 HUMAN PRESCRIPTION DRUG ELIDEL Pimecrolimus CREAM TOPICAL 20011202 NDA NDA021302 Valeant Pharmaceuticals North America LLC PIMECROLIMUS 10 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 0187-5103_6ce615d6-ec6c-48cf-b3f7-d43ddabc6731 0187-5103 HUMAN PRESCRIPTION DRUG ELIDEL Pimecrolimus CREAM TOPICAL 20011202 NDA NDA021302 Valeant Pharmaceuticals North America LLC PIMECROLIMUS 10 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 0187-5104_55989c60-a53f-45fe-a543-894782c85f91 0187-5104 HUMAN PRESCRIPTION DRUG Xerese Acyclovir and Hydrocortisone CREAM TOPICAL 20090731 NDA NDA022436 Valeant Pharmaceuticals North America LLC ACYCLOVIR; HYDROCORTISONE 50; 10 mg/g; mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0187-5115_152e65eb-3bdb-4062-9c3f-168f3806b51d 0187-5115 HUMAN PRESCRIPTION DRUG Ertaczo Sertaconazole Nitrate CREAM TOPICAL 20031210 NDA NDA021385 Valeant Pharmaceuticals North America LLC SERTACONAZOLE NITRATE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0187-5140_c63f5fa9-cfea-47c1-a0fd-f52252fc21a3 0187-5140 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 19970207 NDA NDA020475 Valeant Pharmaceuticals North America LLC TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0187-5144_c63f5fa9-cfea-47c1-a0fd-f52252fc21a3 0187-5144 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20020510 NDA NDA020475 Valeant Pharmaceuticals North America LLC TRETINOIN .4 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0187-5146_c63f5fa9-cfea-47c1-a0fd-f52252fc21a3 0187-5146 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20171023 NDA NDA020475 Valeant Pharmaceuticals North America LLC TRETINOIN .6 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0187-5148_c63f5fa9-cfea-47c1-a0fd-f52252fc21a3 0187-5148 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20140128 NDA NDA020475 Valeant Pharmaceuticals North America LLC TRETINOIN .8 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0187-5150_27de0351-7a7a-4ecf-babf-048d6cb29d3c 0187-5150 HUMAN PRESCRIPTION DRUG Renova Tretinoin CREAM TOPICAL 20000831 NDA NDA021108 Valeant Pharmaceuticals North America LLC TRETINOIN .2 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0187-5160_fb15d4a0-1c4b-4179-90aa-f576c59a90b2 0187-5160 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin CREAM TOPICAL 19881030 NDA NDA019049 Valeant Pharmaceuticals North America LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0187-5162_fb15d4a0-1c4b-4179-90aa-f576c59a90b2 0187-5162 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin CREAM TOPICAL 19740730 NDA NDA017522 Valeant Pharmaceuticals North America LLC TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0187-5164_fb15d4a0-1c4b-4179-90aa-f576c59a90b2 0187-5164 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin CREAM TOPICAL 19730430 NDA NDA017340 Valeant Pharmaceuticals North America LLC TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0187-5170_fb15d4a0-1c4b-4179-90aa-f576c59a90b2 0187-5170 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin GEL TOPICAL 19750730 NDA NDA017579 Valeant Pharmaceuticals North America LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0187-5172_fb15d4a0-1c4b-4179-90aa-f576c59a90b2 0187-5172 HUMAN PRESCRIPTION DRUG Retin-A Tretinoin GEL TOPICAL 19790730 NDA NDA017955 Valeant Pharmaceuticals North America LLC TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0187-5180_99ca6a22-4f79-46be-a945-f286eec520de 0187-5180 HUMAN PRESCRIPTION DRUG Penlac ciclopirox SOLUTION TOPICAL 20130501 NDA NDA021022 Valeant Pharmaceuticals North America LLC CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 0187-5190_01abb87e-1d4e-4f45-bf8c-76b9f9c3227d 0187-5190 HUMAN PRESCRIPTION DRUG Benzaclin Clindamycin phosphate and benzoyl peroxide GEL TOPICAL 20001221 NDA NDA050756 Valeant Pharmaceuticals North America LLC CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE 10; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0187-5198_9a05e37c-fe70-49ed-8461-30205bda04e1 0187-5198 HUMAN PRESCRIPTION DRUG Klaron sulfacetamide sodium LOTION TOPICAL 19961223 NDA NDA019931 Valeant Pharmaceuticals North America LLC SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0187-5200_fc805fee-4a6a-4807-91cc-dc450887cb37 0187-5200 HUMAN PRESCRIPTION DRUG Carac fluorouracil CREAM TOPICAL 20130628 NDA NDA020985 Valeant Pharmaceuticals North America LLC FLUOROURACIL 5 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0187-5202_6593ad1e-1869-46f2-885e-aa220aefadb2 0187-5202 HUMAN PRESCRIPTION DRUG Noritate metronidazole CREAM TOPICAL 20130809 NDA NDA020743 Valeant Pharmaceuticals North America LLC METRONIDAZOLE 10 mg/60g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0187-5205_c164e742-b366-415f-a207-cd09cca3fb99 0187-5205 HUMAN PRESCRIPTION DRUG Benzamycin erythromycin and benzoyl peroxide KIT 19841026 NDA NDA050557 Valeant Pharmaceuticals North America LLC N 20181231 0187-5400_424ea0a1-aaad-43b3-b0be-f78c27e8858c 0187-5400 HUMAN PRESCRIPTION DRUG JUBLIA efinaconazole SOLUTION TOPICAL 20140606 NDA NDA203567 Valeant Pharmaceuticals North America LLC EFINACONAZOLE 100 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0187-5465_c6863713-74a5-48a1-8715-27f201eb3c79 0187-5465 HUMAN OTC DRUG Caladryl Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride LOTION TOPICAL 20130816 OTC MONOGRAPH FINAL part347 Valeant Pharmaceuticals North America LLC FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 1.36; 78.65; 10 mg/mL; mg/mL; mg/mL N 20181231 0187-5466_9653b0cf-f0f6-4749-b614-752c12c1d335 0187-5466 HUMAN OTC DRUG Caladryl Clear PRAMOXINE HYDROCHLORIDE and ZINC ACETATE LOTION TOPICAL 20130816 OTC MONOGRAPH FINAL part347 Valeant Pharmaceuticals North America LLC PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 0187-5471_6e8d072e-38c3-4e4b-9422-8290fe07ab68 0187-5471 HUMAN OTC DRUG Ambi Even and Clear Exfoliating Wash Salicylic Acid CREAM TOPICAL 20140715 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 5 mg/g N 20181231 0187-5472_893ac780-1c7c-44f1-a5bd-396034f16082 0187-5472 HUMAN OTC DRUG Ambi Even and Clear Foaming Cleanser Salicylic Acid LIQUID TOPICAL 20140615 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 5 mg/mL N 20181231 0187-5475_36362fb5-6e3c-4ff5-a305-3434392578f9 0187-5475 HUMAN OTC DRUG Ambi Even and Clear Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part352 Valeant Pharmaceuticals North America LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 0187-5479_2e335de0-1593-4abe-94f0-26b492c83fb6 0187-5479 HUMAN OTC DRUG AMBI Fade Normal Skin Hydroquinone and Octinoxate CREAM TOPICAL 20140204 OTC MONOGRAPH NOT FINAL part358A Valeant Pharmaceuticals North America LLC HYDROQUINONE; OCTINOXATE 20; 20 mg/g; mg/g E 20171231 0187-5480_117beed1-353b-4589-a8a4-4c54f7c1485d 0187-5480 HUMAN OTC DRUG AMBI Fade Oily Skin Hydroquinone and Octinoxate CREAM TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part358A Valeant Pharmaceuticals North America LLC HYDROQUINONE; OCTINOXATE 20; 20 mg/g; mg/g E 20171231 0187-5500_18866a5c-d3ca-4f10-8990-47c9d93fb87f 0187-5500 HUMAN OTC DRUG Purpose Octinoxate, Octisalate and Oxybenzone LOTION TOPICAL 20131007 OTC MONOGRAPH NOT FINAL part352 Valeant Pharmaceuticals North America LLC OCTINOXATE; OCTISALATE; OXYBENZONE 76; 50; 30 mg/mL; mg/mL; mg/mL N 20181231 0187-5518_dcb4c3bf-880f-47bc-8ccd-4d71924538ed 0187-5518 HUMAN OTC DRUG Cortaid Intensive Therapy Cooling Hydrocortisone SPRAY TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Valeant Pharmaceuticals North America LLC HYDROCORTISONE 10 g/mL N 20181231 0187-5519_1eb5c85a-6a30-44e5-ab1e-b0c488b34030 0187-5519 HUMAN OTC DRUG Cortaid 12-Hour Advanced Anti-Itch Hydrocortisone CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Valeant Pharmaceuticals North America LLC HYDROCORTISONE 1 g/100g N 20181231 0187-5521_61b8bc20-137c-4049-898e-00206ce3fed8 0187-5521 HUMAN OTC DRUG Cortaid Maximum Strength Hydrocortisone CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Valeant Pharmaceuticals North America LLC HYDROCORTISONE 1 g/100g N 20181231 0187-5525_ad234f26-3b95-40ce-9698-250e846b3880 0187-5525 HUMAN PRESCRIPTION DRUG Targretin bexarotene GEL TOPICAL 20000628 NDA NDA021056 Valeant Pharmaceuticals North America LLC BEXAROTENE 1 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0187-5526_678ff5d9-a380-4b28-8feb-ff9df6a47ef0 0187-5526 HUMAN PRESCRIPTION DRUG Targretin bexarotene CAPSULE, LIQUID FILLED ORAL 19991229 NDA NDA021055 Valeant Pharmaceuticals North America LLC BEXAROTENE 75 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0187-5600_cd8795c3-ca04-4216-9519-16bd96724322 0187-5600 HUMAN PRESCRIPTION DRUG Visudyne verteporfin for injection INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20000412 NDA NDA021119 Valeant Pharmaceuticals North America LLC VERTEPORFIN 15 mg/1 Photoabsorption [MoA],Photoenhancer [EPC],Photosensitizing Activity [PE] N 20181231 0187-5810_95691d90-1d22-4a8d-8b9d-82a9dbc04110 0187-5810 HUMAN PRESCRIPTION DRUG Aplenzin bupropion hydrobromide TABLET, EXTENDED RELEASE ORAL 20080423 NDA NDA022108 Valeant Pharmaceuticals North America LLC BUPROPION HYDROBROMIDE 174 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0187-5811_95691d90-1d22-4a8d-8b9d-82a9dbc04110 0187-5811 HUMAN PRESCRIPTION DRUG Aplenzin bupropion hydrobromide TABLET, EXTENDED RELEASE ORAL 20080423 NDA NDA022108 Valeant Pharmaceuticals North America LLC BUPROPION HYDROBROMIDE 348 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0187-5812_95691d90-1d22-4a8d-8b9d-82a9dbc04110 0187-5812 HUMAN PRESCRIPTION DRUG Aplenzin bupropion hydrobromide TABLET, EXTENDED RELEASE ORAL 20080423 NDA NDA022108 Valeant Pharmaceuticals North America LLC BUPROPION HYDROBROMIDE 522 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0187-6100_922429d0-c637-416f-bc57-1c86c04c11f3 0187-6100 HUMAN OTC DRUG CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20150302 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 20 mg/mL N 20181231 0187-6101_d4c90402-5894-4c75-9752-53dcc6b80d9e 0187-6101 HUMAN OTC DRUG CLENZIDERM THERAPEUTIC BENZOYL PEROXIDE LOTION TOPICAL 20150302 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC BENZOYL PEROXIDE 50 mg/mL N 20181231 0187-6102_a9b244f0-0d9a-4368-a558-e3e909e4e24c 0187-6102 HUMAN OTC DRUG CLENZIDERM PORE THERAPY ACNE TREATMENT SALICYLIC ACID SOLUTION TOPICAL 20150302 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC SALICYLIC ACID 20 mg/mL N 20181231 0187-6103_de6c8f91-520a-4f6d-ba62-8a4f9abd8c8c 0187-6103 HUMAN OTC DRUG CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM SALICYLIC ACID AND BENZOYL PEROXIDE KIT 20150302 OTC MONOGRAPH FINAL part333D Valeant Pharmaceuticals North America LLC N 20181231 0201-4008_608a2dc1-573e-44bd-a5bd-ece3b0712d7b 0201-4008 HUMAN OTC DRUG CALENDULA DIAPER RASH ZINC OXIDE CREAM TOPICAL 20171127 OTC MONOGRAPH FINAL part347 Weleda AG ZINC OXIDE 12 g/100g N 20181231 0206-2409_2d19ba82-6c84-4e70-ba69-09e5bc31c2bf 0206-2409 HUMAN PRESCRIPTION DRUG Zosyn in Galaxy Containers PIPERACILLIN SODIUM and TAZOBACTAM SODIUM INJECTION, SOLUTION INTRAVENOUS 19980301 NDA NDA050750 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TAZOBACTAM SODIUM; PIPERACILLIN SODIUM 250; 2 mg/50mL; g/50mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0206-2411_2d19ba82-6c84-4e70-ba69-09e5bc31c2bf 0206-2411 HUMAN PRESCRIPTION DRUG Zosyn in Galaxy Containers PIPERACILLIN SODIUM and TAZOBACTAM SODIUM INJECTION, SOLUTION INTRAVENOUS 19980301 NDA NDA050750 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TAZOBACTAM SODIUM; PIPERACILLIN SODIUM 375; 3 mg/50mL; g/50mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0206-2413_2d19ba82-6c84-4e70-ba69-09e5bc31c2bf 0206-2413 HUMAN PRESCRIPTION DRUG Zosyn in Galaxy Containers PIPERACILLIN SODIUM and TAZOBACTAM SODIUM INJECTION, SOLUTION INTRAVENOUS 19980301 NDA NDA050750 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TAZOBACTAM SODIUM; PIPERACILLIN SODIUM 500; 4 mg/100mL; g/100mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0206-8852_87c02c02-e11a-45ad-9621-94e95c0b46de 0206-8852 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TAZOBACTAM SODIUM; PIPERACILLIN SODIUM .25; 2 g/10mL; g/10mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0206-8854_87c02c02-e11a-45ad-9621-94e95c0b46de 0206-8854 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TAZOBACTAM SODIUM; PIPERACILLIN SODIUM .375; 3 g/15mL; g/15mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0206-8855_87c02c02-e11a-45ad-9621-94e95c0b46de 0206-8855 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TAZOBACTAM SODIUM; PIPERACILLIN SODIUM .5; 4 g/20mL; g/20mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0206-8859_87c02c02-e11a-45ad-9621-94e95c0b46de 0206-8859 HUMAN PRESCRIPTION DRUG Zosyn Pharmacy Bulk Package PIPERACILLIN SODIUM and TAZOBACTAM SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TAZOBACTAM SODIUM; PIPERACILLIN SODIUM 4.5; 36 g/180mL; g/180mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0206-8860_87c02c02-e11a-45ad-9621-94e95c0b46de 0206-8860 HUMAN PRESCRIPTION DRUG Zosyn in Galaxy Containers TAZOBACTAM SODIUM and PIPERACILLIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19980301 NDA NDA050750 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TAZOBACTAM SODIUM; PIPERACILLIN SODIUM 250; 2 mg/50mL; g/50mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0206-8861_87c02c02-e11a-45ad-9621-94e95c0b46de 0206-8861 HUMAN PRESCRIPTION DRUG Zosyn in Galaxy Containers TAZOBACTAM SODIUM and PIPERACILLIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19980301 NDA NDA050750 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TAZOBACTAM SODIUM; PIPERACILLIN SODIUM 375; 3 mg/50mL; g/50mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0206-8862_87c02c02-e11a-45ad-9621-94e95c0b46de 0206-8862 HUMAN PRESCRIPTION DRUG Zosyn in Galaxy Containers TAZOBACTAM SODIUM and PIPERACILLIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19980301 NDA NDA050750 Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. TAZOBACTAM SODIUM; PIPERACILLIN SODIUM 500; 4 mg/100mL; g/100mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0219-0203_22488c18-7761-40ea-8905-297af63f9a4b 0219-0203 HUMAN OTC DRUG Humphreys Bendito Alcoholado menthol LIQUID TOPICAL 19720111 OTC MONOGRAPH NOT FINAL part348 Humphreys Pharmacal, Incorporated MENTHOL 12.5 mg/mL E 20171231 0219-2020_452b8063-1649-4f06-9b6e-99881ba74453 0219-2020 HUMAN OTC DRUG Humphreys Alcoholado Maravilla ALCOHOL LIQUID TOPICAL 19720111 OTC MONOGRAPH NOT FINAL part333A Humphreys Pharmacal, Incorporated ALCOHOL 70 mL/100mL E 20171231 0219-3103_a9c55662-9362-48f9-a07f-62d865301b7e 0219-3103 HUMAN OTC DRUG Humphreys Baby Teething Relief Very Cherry matricaria recutita, arabica coffee bean, tribasic calcium phosphate PELLET ORAL 20120101 UNAPPROVED HOMEOPATHIC Humphreys Pharmacal, Incorporated MATRICARIA RECUTITA; ARABICA COFFEE BEAN; TRIBASIC CALCIUM PHOSPHATE 3; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 0219-4103_5170ed26-40b2-47df-b7e3-8f0976abef2f 0219-4103 HUMAN OTC DRUG Humphreys Baby Teething Relief Cherry Swift Strips matricaria recutita, arabica coffee bean, tribasic calcium phosphate FILM, SOLUBLE ORAL 20120101 UNAPPROVED HOMEOPATHIC Humphreys Pharmacal, Incorporated MATRICARIA RECUTITA; ARABICA COFFEE BEAN; TRIBASIC CALCIUM PHOSPHATE 3; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 0219-6103_1c039fc9-44a5-4788-a5a3-0e9d9e7d5e7e 0219-6103 HUMAN OTC DRUG Humphreys Baby Teething Relief Original matricaria recutita, arabica coffee bean, tribasic calcium phosphate PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Humphreys Pharmacal, Incorporated MATRICARIA RECUTITA; ARABICA COFFEE BEAN; TRIBASIC CALCIUM PHOSPHATE 3; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 0220-0050_5e979463-04ec-5a24-e053-2a91aa0af8e5 0220-0050 HUMAN OTC DRUG Aconitum napellus ACONITUM NAPELLUS PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ACONITUM NAPELLUS 3 [hp_X]/1 N 20181231 0220-0092_5e980e0d-c7d5-47a8-e053-2a91aa0a1bf3 0220-0092 HUMAN OTC DRUG Aesculus hippocastanum HORSE CHESTNUT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron HORSE CHESTNUT 6 [hp_X]/1 N 20181231 0220-0172_5e98126b-5d1d-8bb7-e053-2991aa0a6590 0220-0172 HUMAN OTC DRUG Allium cepa ONION PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ONION 6 [hp_X]/1 N 20181231 0220-0205_5e97c4fc-9003-71d6-e053-2a91aa0a360d 0220-0205 HUMAN OTC DRUG Alumina ALUMINUM OXIDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ALUMINUM OXIDE 30 [hp_X]/1 N 20181231 0220-0225_5e983eb9-e148-cb88-e053-2991aa0ae477 0220-0225 HUMAN OTC DRUG Ambrosia artemisiaefolia AMBROSIA ARTEMISIIFOLIA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron AMBROSIA ARTEMISIIFOLIA 6 [hp_X]/1 N 20181231 0220-0308_5e98432a-6503-bab8-e053-2a91aa0afaa8 0220-0308 HUMAN OTC DRUG Anacardium orientale SEMECARPUS ANACARDIUM JUICE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SEMECARPUS ANACARDIUM JUICE 6 [hp_C]/1 N 20181231 0220-0372_5e983b65-2bd1-ca0e-e053-2991aa0a62d2 0220-0372 HUMAN OTC DRUG Antimonium crudum ANTIMONY TRISULFIDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ANTIMONY TRISULFIDE 8 [hp_X]/1 N 20181231 0220-0393_5e983b65-2bea-ca0e-e053-2991aa0a62d2 0220-0393 HUMAN OTC DRUG Antimonium tartaricum ANTIMONY POTASSIUM TARTRATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ANTIMONY POTASSIUM TARTRATE 6 [hp_X]/1 N 20181231 0220-0406_5e983b65-2c04-ca0e-e053-2991aa0a62d2 0220-0406 HUMAN OTC DRUG Apis mellifica APIS MELLIFERA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron APIS MELLIFERA 6 [hp_X]/1 N 20181231 0220-0484_5e98459d-eaee-bab6-e053-2a91aa0aee3f 0220-0484 HUMAN OTC DRUG Argentum nitricum SILVER NITRATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SILVER NITRATE 6 [hp_X]/1 N 20181231 0220-0508_5df2b7bc-b80b-2de0-e053-2a91aa0a010a 0220-0508 HUMAN OTC DRUG Arnica ARNICA MONTANA PELLET ORAL 20090501 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA 30 [hp_C]/1 N 20181231 0220-0522_5e985f2c-f65c-c7d1-e053-2a91aa0a883e 0220-0522 HUMAN OTC DRUG Arsenicum album ARSENIC TRIOXIDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARSENIC TRIOXIDE 6 [hp_X]/1 N 20181231 0220-0536_5e9880e9-31a6-2e0b-e053-2991aa0a2290 0220-0536 HUMAN OTC DRUG Arsenicum iodatum ARSENIC TRIIODIDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARSENIC TRIIODIDE 6 [hp_X]/1 N 20181231 0220-0564_5f4a16fd-00fe-0665-e053-2a91aa0ac4a1 0220-0564 HUMAN OTC DRUG Arum triphyllum ARISAEMA TRIPHYLLUM ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARISAEMA TRIPHYLLUM ROOT 6 [hp_X]/1 N 20181231 0220-0636_5f4a2428-1ea2-d9e1-e053-2a91aa0a2ede 0220-0636 HUMAN OTC DRUG Aurum metallicum GOLD PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron GOLD 8 [hp_X]/1 N 20181231 0220-0773_5f4a2d17-226a-7844-e053-2991aa0a5a3d 0220-0773 HUMAN OTC DRUG Baptisia tinctoria BAPTISIA TINCTORIA ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BAPTISIA TINCTORIA ROOT 6 [hp_C]/1 N 20181231 0220-0785_5f4a2428-1ebc-d9e1-e053-2a91aa0a2ede 0220-0785 HUMAN OTC DRUG Baryta carbonica BARIUM CARBONATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BARIUM CARBONATE 8 [hp_X]/1 N 20181231 0220-0797_5f4a4335-6d0b-3be0-e053-2a91aa0a4aa9 0220-0797 HUMAN OTC DRUG Belladonna ATROPA BELLADONNA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ATROPA BELLADONNA 4 [hp_X]/1 N 20181231 0220-0811_5f4a7dc2-4335-09a5-e053-2a91aa0a24ca 0220-0811 HUMAN OTC DRUG Bellis perennis BELLIS PERENNIS PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BELLIS PERENNIS 5 [hp_C]/1 N 20181231 0220-0835_5f4ad743-fafa-d17b-e053-2991aa0a1b72 0220-0835 HUMAN OTC DRUG Berberis vulgaris BERBERIS VULGARIS ROOT BARK PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BERBERIS VULGARIS ROOT BARK 4 [hp_X]/1 N 20181231 0220-0871_5f4b8475-a794-3832-e053-2991aa0a406e 0220-0871 HUMAN OTC DRUG Blatta orientalis BLATTA ORIENTALIS PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BLATTA ORIENTALIS 5 [hp_C]/1 N 20181231 0220-0887_5f4b9a18-aa7c-61d9-e053-2991aa0a7443 0220-0887 HUMAN OTC DRUG Borax SODIUM BORATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SODIUM BORATE 6 [hp_X]/1 N 20181231 0220-0915_5f4b8d08-2bb3-331c-e053-2991aa0ad4da 0220-0915 HUMAN OTC DRUG Bryonia BRYONIA ALBA ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BRYONIA ALBA ROOT 4 [hp_X]/1 N 20181231 0220-1046_5f4d9a01-b2fa-3e37-e053-2a91aa0a9a90 0220-1046 HUMAN OTC DRUG Calcarea carbonica OYSTER SHELL CALCIUM CARBONATE, CRUDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron OYSTER SHELL CALCIUM CARBONATE, CRUDE 8 [hp_X]/1 N 20181231 0220-1060_5f4da67c-aa26-079f-e053-2a91aa0ac1ee 0220-1060 HUMAN OTC DRUG Calcarea fluorica CALCIUM FLUORIDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALCIUM FLUORIDE 8 [hp_X]/1 N 20181231 0220-1085_5f4dc2a4-1be2-4897-e053-2991aa0a98ba 0220-1085 HUMAN OTC DRUG Calcarea phosphorica TRIBASIC CALCIUM PHOSPHATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron TRIBASIC CALCIUM PHOSPHATE 6 [hp_X]/1 N 20181231 0220-1098_5f9b4b2c-6820-6667-e053-2991aa0a0cc9 0220-1098 HUMAN OTC DRUG Calcarea sulphurica CALCIUM SULFATE ANHYDROUS PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALCIUM SULFATE ANHYDROUS 6 [hp_X]/1 N 20181231 0220-1103_5f9aae79-5560-39cc-e053-2a91aa0a9e73 0220-1103 HUMAN OTC DRUG Calendula officinalis CALENDULA OFFICINALIS FLOWERING TOP PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_X]/1 N 20181231 0220-1104_5e20cb1f-300a-968f-e053-2a91aa0a1a1e 0220-1104 HUMAN OTC DRUG Calendula CALENDULA OFFICINALIS FLOWERING TOP OINTMENT TOPICAL 19880717 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g N 20181231 0220-1105_5e212948-682f-bdf2-e053-2991aa0a649f 0220-1105 HUMAN OTC DRUG Calendula CALENDULA OFFICINALIS FLOWERING TOP GEL TOPICAL 19930930 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g N 20181231 0220-1106_5e218764-e6de-85b3-e053-2a91aa0a871c 0220-1106 HUMAN OTC DRUG Calendula CALENDULA OFFICINALIS FLOWERING TOP LOTION TOPICAL 19930930 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/mL N 20181231 0220-1108_5e214806-f764-28cd-e053-2a91aa0abb80 0220-1108 HUMAN OTC DRUG Calendula CALENDULA OFFICINALIS FLOWERING TOP GEL TOPICAL 19900413 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g N 20181231 0220-1109_5e1fc297-6421-b975-e053-2a91aa0ad548 0220-1109 HUMAN OTC DRUG Calendula CALENDULA OFFICINALIS FLOWERING TOP CREAM TOPICAL 20060321 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g N 20181231 0220-1109_5e2096c3-dcd9-ac3a-e053-2991aa0a5025 0220-1109 HUMAN OTC DRUG CALENDULA CALENDULA CREAM TOPICAL 20160229 UNAPPROVED HOMEOPATHIC Boiron CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g N 20181231 0220-1133_5f9b6ef4-296a-b263-e053-2a91aa0a5533 0220-1133 HUMAN OTC DRUG Candida albicans CANDIDA ALBICANS PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CANDIDA ALBICANS 8 [hp_X]/1 N 20181231 0220-1145_5f9b93b6-1866-332d-e053-2991aa0a1e12 0220-1145 HUMAN OTC DRUG Cantharis LYTTA VESICATORIA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron LYTTA VESICATORIA 30 [hp_X]/1 N 20181231 0220-1158_5f9a8e1b-9b3d-1430-e053-2a91aa0afc83 0220-1158 HUMAN OTC DRUG Carbo vegetabilis ACTIVATED CHARCOAL PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ACTIVATED CHARCOAL 8 [hp_X]/1 N 20181231 0220-1223_5f9c005f-8545-5d0f-e053-2a91aa0ab345 0220-1223 HUMAN OTC DRUG Caulophyllum thalictroides CAULOPHYLLUM THALICTROIDES ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CAULOPHYLLUM THALICTROIDES ROOT 30 [hp_X]/1 N 20181231 0220-1227_5f9a7684-343c-fa97-e053-2a91aa0a3e09 0220-1227 HUMAN OTC DRUG Causticum CAUSTICUM PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CAUSTICUM 6 [hp_X]/1 N 20181231 0220-1267_5f9c2537-16fb-5019-e053-2991aa0adabb 0220-1267 HUMAN OTC DRUG Chamomilla MATRICARIA RECUTITA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron MATRICARIA RECUTITA 6 [hp_X]/1 N 20181231 0220-1277_5f9c3457-6aea-22ca-e053-2a91aa0a0f6a 0220-1277 HUMAN OTC DRUG Cheiranthus cheiri ERYSIMUM CHEIRI PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ERYSIMUM CHEIRI 9 [hp_C]/1 N 20181231 0220-1281_5f9c3457-6afd-22ca-e053-2a91aa0a0f6a 0220-1281 HUMAN OTC DRUG Chelidonium majus CHELIDONIUM MAJUS PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CHELIDONIUM MAJUS 4 [hp_X]/1 N 20181231 0220-1325_5f9b892f-7ee0-498b-e053-2a91aa0a3026 0220-1325 HUMAN OTC DRUG Chininum sulphuricum QUININE SULFATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron QUININE SULFATE 6 [hp_C]/1 N 20181231 0220-1385_5f9befa7-67b9-244d-e053-2991aa0a5410 0220-1385 HUMAN OTC DRUG Cimicifuga racemosa BLACK COHOSH PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BLACK COHOSH 30 [hp_X]/1 N 20181231 0220-1389_5f9c748e-9e27-ce5f-e053-2991aa0a507a 0220-1389 HUMAN OTC DRUG Cina ARTEMISIA CINA PRE-FLOWERING TOP PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARTEMISIA CINA PRE-FLOWERING TOP 30 [hp_X]/1 N 20181231 0220-1393_5f9c7f34-c6d7-6334-e053-2991aa0a1709 0220-1393 HUMAN OTC DRUG Cinchona officinalis CINCHONA OFFICINALIS BARK PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CINCHONA OFFICINALIS BARK 6 [hp_X]/1 N 20181231 0220-1458_5f9c748e-9e42-ce5f-e053-2991aa0a507a 0220-1458 HUMAN OTC DRUG Cocculus indicus ANAMIRTA COCCULUS SEED PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ANAMIRTA COCCULUS SEED 4 [hp_X]/1 N 20181231 0220-1475_5f9c2eb6-57b5-6336-e053-2991aa0af234 0220-1475 HUMAN OTC DRUG Coffea cruda ARABICA COFFEE BEAN PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARABICA COFFEE BEAN 6 [hp_X]/1 N 20181231 0220-1488_5f9c7f34-c6f2-6334-e053-2991aa0a1709 0220-1488 HUMAN OTC DRUG Colchicum autumnale COLCHICUM AUTUMNALE BULB PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron COLCHICUM AUTUMNALE BULB 6 [hp_C]/1 N 20181231 0220-1496_5f9ca0a0-c4a7-90c6-e053-2a91aa0aab2f 0220-1496 HUMAN OTC DRUG Colocynthis CITRULLUS COLOCYNTHIS FRUIT PULP PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CITRULLUS COLOCYNTHIS FRUIT PULP 6 [hp_X]/1 N 20181231 0220-1525_5f9ca0a0-c4bf-90c6-e053-2a91aa0aab2f 0220-1525 HUMAN OTC DRUG Conium maculatum CONIUM MACULATUM FLOWERING TOP PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CONIUM MACULATUM FLOWERING TOP 6 [hp_X]/1 N 20181231 0220-1613_5f9c9b7c-f3d9-9f88-e053-2991aa0a69ab 0220-1613 HUMAN OTC DRUG Cuprum metallicum COPPER PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron COPPER 8 [hp_X]/1 N 20181231 0220-1791_5f9cc132-1cd0-ce54-e053-2a91aa0abf1b 0220-1791 HUMAN OTC DRUG Drosera rotundifolia DROSERA ROTUNDIFOLIA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron DROSERA ROTUNDIFOLIA 6 [hp_X]/1 N 20181231 0220-1799_5f9cd233-6c22-5b52-e053-2991aa0ab729 0220-1799 HUMAN OTC DRUG Dulcamara SOLANUM DULCAMARA TOP PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SOLANUM DULCAMARA TOP 6 [hp_X]/1 N 20181231 0220-1852_5f9cd990-8da7-e7ed-e053-2a91aa0a3dd2 0220-1852 HUMAN OTC DRUG Echinacea angustifolia ECHINACEA ANGUSTIFOLIA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ECHINACEA ANGUSTIFOLIA 4 [hp_X]/1 N 20181231 0220-1967_5f9d27fe-53f1-6a6e-e053-2a91aa0a4d54 0220-1967 HUMAN OTC DRUG Eupatorium perfoliatum EUPATORIUM PERFOLIATUM FLOWERING TOP PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron EUPATORIUM PERFOLIATUM FLOWERING TOP 4 [hp_X]/1 N 20181231 0220-1988_5f9d1d8c-c18e-58dc-e053-2a91aa0a7618 0220-1988 HUMAN OTC DRUG Euphrasia officinalis EUPHRASIA STRICTA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron EUPHRASIA STRICTA 6 [hp_X]/1 N 20181231 0220-2097_5f9d3951-1ddf-8837-e053-2991aa0a6ff5 0220-2097 HUMAN OTC DRUG Ferrum phosphoricum FERRUM PHOSPHORICUM PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron FERRUM PHOSPHORICUM 8 [hp_X]/1 N 20181231 0220-2133_5f9d3951-1dfa-8837-e053-2991aa0a6ff5 0220-2133 HUMAN OTC DRUG Folliculinum ESTRONE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ESTRONE 12 [hp_C]/1 N 20181231 0220-2235_5f9d3951-1e11-8837-e053-2991aa0a6ff5 0220-2235 HUMAN OTC DRUG Galphimia glauca GALPHIMIA GLAUCA FLOWERING TOP PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron GALPHIMIA GLAUCA FLOWERING TOP 6 [hp_C]/1 N 20181231 0220-2247_5f9e719f-98e2-5850-e053-2a91aa0a3ec1 0220-2247 HUMAN OTC DRUG Gelsemium sempervirens GELSEMIUM SEMPERVIRENS ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]/1 N 20181231 0220-2293_5f9e5fee-ef08-5970-e053-2a91aa0a0917 0220-2293 HUMAN OTC DRUG Glonoinum NITROGLYCERIN PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron NITROGLYCERIN 6 [hp_X]/1 N 20181231 0220-2325_5f9eb638-fc08-51fc-e053-2991aa0a437b 0220-2325 HUMAN OTC DRUG Graphites GRAPHITE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron GRAPHITE 8 [hp_X]/1 N 20181231 0220-2353_5f9ea8a2-e6c6-bf80-e053-2991aa0ad565 0220-2353 HUMAN OTC DRUG Gun powder POTASSIUM NITRATE, ACTIVATED CHARCOAL, SULFUR PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron POTASSIUM NITRATE; ACTIVATED CHARCOAL; SULFUR 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 0220-2414_5f9ed3c3-6d71-54e3-e053-2991aa0aaf76 0220-2414 HUMAN OTC DRUG Hamamelis virginiana HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6 [hp_X]/1 N 20181231 0220-2428_5f9ed8a7-90eb-0fd6-e053-2991aa0ad919 0220-2428 HUMAN OTC DRUG Hekla lava HEKLA LAVA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron HEKLA LAVA 8 [hp_X]/1 N 20181231 0220-2448_5f9ed8a7-9107-0fd6-e053-2991aa0ad919 0220-2448 HUMAN OTC DRUG Helleborus niger HELLEBORUS NIGER ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron HELLEBORUS NIGER ROOT 6 [hp_C]/1 N 20181231 0220-2464_5f9ed8a7-9119-0fd6-e053-2991aa0ad919 0220-2464 HUMAN OTC DRUG Hepar sulphuris calcareum CALCIUM SULFIDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CALCIUM SULFIDE 8 [hp_X]/1 N 20181231 0220-2488_321a6970-bf9a-11e7-81fc-424c58303031 0220-2488 HUMAN OTC DRUG Histaminum 30C Allergy Relief Histaminum Hydrochloricum PELLET ORAL 20160317 UNAPPROVED HOMEOPATHIC Laboratoires Boiron HISTAMINE DIHYDROCHLORIDE 30 [hp_C]/1 N 20181231 0220-2522_5f9eee89-36b6-a308-e053-2a91aa0a0bb7 0220-2522 HUMAN OTC DRUG Hydrastis canadensis GOLDENSEAL PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron GOLDENSEAL 6 [hp_X]/1 N 20181231 0220-2542_5f9f0111-467a-bb5a-e053-2a91aa0a20cd 0220-2542 HUMAN OTC DRUG Hyoscyamus niger HYOSCYAMUS NIGER PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron HYOSCYAMUS NIGER 6 [hp_X]/1 N 20181231 0220-2546_5f9f08e7-b0de-4b59-e053-2991aa0a1f10 0220-2546 HUMAN OTC DRUG Hypericum perforatum HYPERICUM PERFORATUM PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron HYPERICUM PERFORATUM 6 [hp_X]/1 N 20181231 0220-2613_5f9f02ae-fd9d-58ad-e053-2a91aa0a3bae 0220-2613 HUMAN OTC DRUG Ignatia amara STRYCHNOS IGNATII SEED PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron STRYCHNOS IGNATII SEED 6 [hp_X]/1 N 20181231 0220-2651_604ec5d3-b3bd-5978-e053-2a91aa0a65b8 0220-2651 VACCINE Influenzinum INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 0220-2659_5f9eb638-fc2c-51fc-e053-2991aa0a437b 0220-2659 HUMAN OTC DRUG Iodium IODINE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron IODINE 6 [hp_X]/1 N 20181231 0220-2667_5f9f20f7-2721-be17-e053-2991aa0a1ae3 0220-2667 HUMAN OTC DRUG Ipecacuanha IPECAC PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron IPECAC 6 [hp_X]/1 N 20181231 0220-2692_5f9f3747-f719-8d05-e053-2a91aa0a23dc 0220-2692 HUMAN OTC DRUG Iris versicolor IRIS VERSICOLOR ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron IRIS VERSICOLOR ROOT 5 [hp_C]/1 N 20181231 0220-2854_5fd81049-bd93-fc90-e053-2a91aa0a7916 0220-2854 HUMAN OTC DRUG Kali bichromicum POTASSIUM DICHROMATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron POTASSIUM DICHROMATE 12 [hp_X]/1 N 20181231 0220-2863_5fd81049-bdae-fc90-e053-2a91aa0a7916 0220-2863 HUMAN OTC DRUG Kali carbonicum POTASSIUM CARBONATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron POTASSIUM CARBONATE 6 [hp_X]/1 N 20181231 0220-2887_5fd81049-bdcb-fc90-e053-2a91aa0a7916 0220-2887 HUMAN OTC DRUG Kali iodatum POTASSIUM IODIDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron POTASSIUM IODIDE 6 [hp_X]/1 N 20181231 0220-2891_5fd842ae-cbd4-2135-e053-2a91aa0ac914 0220-2891 HUMAN OTC DRUG Kali muriaticum POTASSIUM CHLORIDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron POTASSIUM CHLORIDE 6 [hp_X]/1 N 20181231 0220-2908_5fd863eb-33cd-d426-e053-2a91aa0a3f31 0220-2908 HUMAN OTC DRUG Kali phosphoricum POTASSIUM PHOSPHATE, DIBASIC PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron POTASSIUM PHOSPHATE, DIBASIC 6 [hp_X]/1 N 20181231 0220-2921_5fd89569-e963-24e6-e053-2a91aa0aed8c 0220-2921 HUMAN OTC DRUG Kali sulphuricum POTASSIUM SULFATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron POTASSIUM SULFATE 6 [hp_X]/1 N 20181231 0220-2946_5fd8d14c-c2c0-de71-e053-2991aa0a7225 0220-2946 HUMAN OTC DRUG Kreosotum WOOD CREOSOTE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron WOOD CREOSOTE 12 [hp_C]/1 N 20181231 0220-3023_5fd8f0b6-4bff-0a42-e053-2991aa0acdf1 0220-3023 HUMAN OTC DRUG Lachesis mutus LACHESIS MUTA VENOM PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron LACHESIS MUTA VENOM 8 [hp_X]/1 N 20181231 0220-3077_5fda0425-94a6-7d05-e053-2a91aa0a7b1a 0220-3077 HUMAN OTC DRUG Ledum palustre LEDUM PALUSTRE TWIG PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron LEDUM PALUSTRE TWIG 6 [hp_X]/1 N 20181231 0220-3147_5fda23b2-d073-a7f9-e053-2a91aa0ad6d0 0220-3147 HUMAN OTC DRUG Lobelia inflata LOBELIA INFLATA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron LOBELIA INFLATA 30 [hp_X]/1 N 20181231 0220-3179_5fda2d9d-288b-74a2-e053-2991aa0ae58f 0220-3179 HUMAN OTC DRUG Lycopodium clavatum LYCOPODIUM CLAVATUM SPORE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/1 N 20181231 0220-3262_5fda1b33-1813-9bac-e053-2a91aa0a3581 0220-3262 HUMAN OTC DRUG Magnesia phosphorica MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 8 [hp_X]/1 N 20181231 0220-3329_61e659a2-f4b0-42db-e053-2991aa0ab8f5 0220-3329 HUMAN OTC DRUG MEDULLA OSSIS SUIS SUS SCROFA BONE MARROW PELLET ORAL 20180108 UNAPPROVED HOMEOPATHIC BOIRON SUS SCROFA BONE MARROW 8 [hp_X]/8[hp_X] N 20191231 0220-3419_5fda3b2d-28d0-c75d-e053-2a91aa0a1be2 0220-3419 HUMAN OTC DRUG Mercurius solubilis MERCURIUS SOLUBILIS PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron MERCURIUS SOLUBILIS 30 [hp_X]/1 N 20181231 0220-3432_5fda3b2d-28ea-c75d-e053-2a91aa0a1be2 0220-3432 HUMAN OTC DRUG Mercurius vivus MERCURY PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron MERCURY 12 [hp_C]/1 N 20181231 0220-3441_5fda6548-d2d8-7164-e053-2991aa0ae29c 0220-3441 HUMAN OTC DRUG Mezereum DAPHNE MEZEREUM BARK PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron DAPHNE MEZEREUM BARK 6 [hp_X]/1 N 20181231 0220-3577_5fda8549-a824-36c0-e053-2991aa0a7cb9 0220-3577 HUMAN OTC DRUG Natrum carbonicum SODIUM CARBONATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SODIUM CARBONATE 6 [hp_X]/1 N 20181231 0220-3593_5fda8c0d-0d1a-04cf-e053-2a91aa0a9b63 0220-3593 HUMAN OTC DRUG Natrum muriaticum SODIUM CHLORIDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SODIUM CHLORIDE 3 [hp_X]/1 N 20181231 0220-3611_5fda8343-34d0-a1d7-e053-2991aa0a4d7b 0220-3611 HUMAN OTC DRUG Natrum phosphoricum SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6 [hp_X]/1 N 20181231 0220-3629_5fda9fe9-a775-4204-e053-2a91aa0a639c 0220-3629 HUMAN OTC DRUG Natrum sulphuricum SODIUM SULFATE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SODIUM SULFATE 6 [hp_X]/1 N 20181231 0220-3665_5fda9fe9-a796-4204-e053-2a91aa0a639c 0220-3665 HUMAN OTC DRUG Nitricum acidum NITRIC ACID PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron NITRIC ACID 6 [hp_X]/1 N 20181231 0220-3681_5e333da7-8882-ac5d-e053-2a91aa0abc2f 0220-3681 HUMAN OTC DRUG Nux Vomica STRYCHNOS NUX-VOMICA SEED PELLET ORAL 20120101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/1 N 20181231 0220-3936_5fda8549-a840-36c0-e053-2991aa0a7cb9 0220-3936 HUMAN OTC DRUG Passiflora incarnata PASSIFLORA INCARNATA FLOWERING TOP PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron PASSIFLORA INCARNATA FLOWERING TOP 4 [hp_X]/1 N 20181231 0220-3976_603e4e22-64d8-38ff-e053-2991aa0a2842 0220-3976 HUMAN OTC DRUG Petroleum KEROSENE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron KEROSENE 30 [hp_X]/1 N 20181231 0220-4000_5fdae00f-8893-0f19-e053-2a91aa0a1a94 0220-4000 HUMAN OTC DRUG Phosphoricum acidum PHOSPHORIC ACID PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron PHOSPHORIC ACID 6 [hp_X]/1 N 20181231 0220-4004_5fdafe3b-9b28-222d-e053-2991aa0a5515 0220-4004 HUMAN OTC DRUG Phosphorus PHOSPHORUS PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron PHOSPHORUS 12 [hp_X]/1 N 20181231 0220-4022_5fdb19a1-3915-4f3e-e053-2a91aa0a904f 0220-4022 HUMAN OTC DRUG Phytolacca decandra PHYTOLACCA AMERICANA ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron PHYTOLACCA AMERICANA ROOT 6 [hp_X]/1 N 20181231 0220-4122_5fdb0ec2-718c-3e48-e053-2991aa0a971b 0220-4122 HUMAN OTC DRUG Plumbum metallicum LEAD PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron LEAD 6 [hp_C]/1 N 20181231 0220-4130_5fdb08aa-7236-45e0-e053-2a91aa0a856b 0220-4130 HUMAN OTC DRUG Podophyllum peltatum PODOPHYLLUM PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron PODOPHYLLUM 6 [hp_X]/1 N 20181231 0220-4178_5fdb3628-134d-7db1-e053-2a91aa0a4ae9 0220-4178 HUMAN OTC DRUG Pulsatilla ANEMONE PATENS PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ANEMONE PATENS 6 [hp_X]/1 N 20181231 0220-4190_e0c519d0-7c6a-11e6-87bf-424c58303031 0220-4190 HUMAN OTC DRUG Pyrogenium RANCID BEEF PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron RANCID BEEF 6 [hp_C]/1 E 20171231 0220-4309_5fdb6fc6-f31f-c5ba-e053-2a91aa0a565d 0220-4309 HUMAN OTC DRUG Radium bromatum RADIUM BROMIDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron RADIUM BROMIDE 9 [hp_C]/1 N 20181231 0220-4317_60127c73-5902-2bd0-e053-2a91aa0a7a65 0220-4317 HUMAN OTC DRUG Ranunculus bulbosus RANUNCULUS BULBOSUS PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron RANUNCULUS BULBOSUS 6 [hp_C]/1 N 20181231 0220-4377_6012b257-0ffe-416e-e053-2991aa0ad488 0220-4377 HUMAN OTC DRUG Rhododendron chrysanthum RHODODENDRON AUREUM LEAF PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron RHODODENDRON AUREUM LEAF 6 [hp_C]/1 N 20181231 0220-4393_6012c836-5826-5faa-e053-2a91aa0a3ae3 0220-4393 HUMAN OTC DRUG Rhus toxicodendron TOXICODENDRON PUBESCENS LEAF PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron TOXICODENDRON PUBESCENS LEAF 7 [hp_X]/1 N 20181231 0220-4435_6012c596-6d9f-109d-e053-2991aa0ac905 0220-4435 HUMAN OTC DRUG Rumex crispus RUMEX CRISPUS ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron RUMEX CRISPUS ROOT 6 [hp_X]/1 N 20181231 0220-4443_6012c596-6db6-109d-e053-2991aa0ac905 0220-4443 HUMAN OTC DRUG Ruta graveolens RUTA GRAVEOLENS FLOWERING TOP PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron RUTA GRAVEOLENS FLOWERING TOP 30 [hp_X]/1 N 20181231 0220-4502_6012e974-19ac-1393-e053-2a91aa0ae906 0220-4502 HUMAN OTC DRUG Sabadilla SCHOENOCAULON OFFICINALE SEED PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SCHOENOCAULON OFFICINALE SEED 6 [hp_X]/1 N 20181231 0220-4510_6012e974-19c4-1393-e053-2a91aa0ae906 0220-4510 HUMAN OTC DRUG Sabina JUNIPERUS SABINA LEAFY TWIG PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron JUNIPERUS SABINA LEAFY TWIG 30 [hp_X]/1 N 20181231 0220-4546_60130294-4575-7497-e053-2991aa0abb94 0220-4546 HUMAN OTC DRUG Sambucus nigra SAMBUCUS NIGRA FLOWERING TOP PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SAMBUCUS NIGRA FLOWERING TOP 8 [hp_X]/1 N 20181231 0220-4550_6012ec5f-b739-5c24-e053-2991aa0ab78c 0220-4550 HUMAN OTC DRUG Sanguinaria canadensis SANGUINARIA CANADENSIS ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SANGUINARIA CANADENSIS ROOT 4 [hp_X]/1 N 20181231 0220-4562_60132265-445f-7e66-e053-2991aa0a8237 0220-4562 HUMAN OTC DRUG Saponaria officinalis SAPONARIA OFFICINALIS ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SAPONARIA OFFICINALIS ROOT 6 [hp_X]/1 N 20181231 0220-4578_60130ef8-c741-3881-e053-2a91aa0a24ea 0220-4578 HUMAN OTC DRUG Sarsaparilla SMILAX REGELII ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SMILAX REGELII ROOT 6 [hp_C]/1 N 20181231 0220-4614_603e3288-285d-0753-e053-2991aa0affd0 0220-4614 HUMAN OTC DRUG Secale cornutum CLAVICEPS PURPUREA SCLEROTIUM PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CLAVICEPS PURPUREA SCLEROTIUM 6 [hp_C]/1 N 20181231 0220-4622_603e3288-27d0-0753-e053-2991aa0affd0 0220-4622 HUMAN OTC DRUG Selenium metallicum SELENIUM PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SELENIUM 6 [hp_C]/1 N 20181231 0220-4646_603e2b01-df34-d918-e053-2a91aa0adfe0 0220-4646 HUMAN OTC DRUG Sepia SEPIA OFFICINALIS JUICE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SEPIA OFFICINALIS JUICE 8 [hp_X]/1 N 20181231 0220-4664_6013104b-3f45-687c-e053-2991aa0a383b 0220-4664 HUMAN OTC DRUG Silicea SILICON DIOXIDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SILICON DIOXIDE 8 [hp_X]/1 N 20181231 0220-4710_603e2467-1341-dfad-e053-2991aa0ae7f2 0220-4710 HUMAN OTC DRUG Spigelia anthelmia SPIGELIA ANTHELMIA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SPIGELIA ANTHELMIA 6 [hp_C]/1 N 20181231 0220-4726_60134696-7800-82b1-e053-2a91aa0a5fb8 0220-4726 HUMAN OTC DRUG Spongia tosta SPONGIA OFFICINALIS SKELETON, ROASTED PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SPONGIA OFFICINALIS SKELETON, ROASTED 8 [hp_X]/1 N 20181231 0220-4743_601250c0-102b-df96-e053-2991aa0aefb9 0220-4743 HUMAN OTC DRUG Staphysagria DELPHINIUM STAPHISAGRIA SEED PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron DELPHINIUM STAPHISAGRIA SEED 6 [hp_X]/1 N 20181231 0220-4759_603df1f8-33ee-983c-e053-2a91aa0a954a 0220-4759 HUMAN OTC DRUG Sticta pulmonaria LOBARIA PULMONARIA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron LOBARIA PULMONARIA 5 [hp_C]/1 N 20181231 0220-4771_60134696-781b-82b1-e053-2a91aa0a5fb8 0220-4771 HUMAN OTC DRUG Stramonium DATURA STRAMONIUM PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron DATURA STRAMONIUM 6 [hp_C]/1 N 20181231 0220-4823_6013756e-6b59-e5a7-e053-2a91aa0abcbe 0220-4823 HUMAN OTC DRUG Sulphur SULFUR PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SULFUR 6 [hp_X]/1 N 20181231 0220-4837_6011e637-57f2-1e67-e053-2991aa0a3374 0220-4837 HUMAN OTC DRUG Sulphur iodatum SULFUR IODIDE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SULFUR IODIDE 6 [hp_C]/1 N 20181231 0220-4857_6013d2df-4c20-2fa9-e053-2a91aa0a1d74 0220-4857 HUMAN OTC DRUG Symphytum officinale COMFREY ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron COMFREY ROOT 6 [hp_X]/1 N 20181231 0220-4916_6013ee17-5cf3-4a55-e053-2991aa0a7699 0220-4916 HUMAN OTC DRUG Tabacum TOBACCO LEAF PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron TOBACCO LEAF 6 [hp_C]/1 N 20181231 0220-4941_602c8d13-0fbd-8143-e053-2a91aa0acb3a 0220-4941 HUMAN OTC DRUG Tarentula hispana LYCOSA TARANTULA PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron LYCOSA TARANTULA 6 [hp_C]/1 N 20181231 0220-4953_602c50fc-778d-745e-e053-2a91aa0afa39 0220-4953 HUMAN OTC DRUG Tellurium metallicum TELLURIUM PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron TELLURIUM 30 [hp_C]/1 N 20181231 0220-4998_6013e330-6e27-64b6-e053-2a91aa0aaf44 0220-4998 HUMAN OTC DRUG Thuja occidentalis THUJA OCCIDENTALIS LEAFY TWIG PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 N 20181231 0220-5016_6013967e-0bef-4af3-e053-2991aa0a15c5 0220-5016 HUMAN OTC DRUG Thyroidinum THYROID, UNSPECIFIED PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron THYROID, UNSPECIFIED 8 [hp_X]/1 N 20181231 0220-5146_60142f29-fa99-2967-e053-2a91aa0a1e21 0220-5146 HUMAN OTC DRUG Urtica urens URTICA URENS PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron URTICA URENS 6 [hp_X]/1 N 20181231 0220-5217_6013ee03-4b9a-6d9d-e053-2a91aa0a8115 0220-5217 HUMAN OTC DRUG Valeriana officinalis VALERIAN PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron VALERIAN 4 [hp_X]/1 N 20181231 0220-5233_6013ee03-4baf-6d9d-e053-2a91aa0a8115 0220-5233 HUMAN OTC DRUG Veratrum album VERATRUM ALBUM ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron VERATRUM ALBUM ROOT 6 [hp_C]/1 N 20181231 0220-5307_60145740-0661-e835-e053-2991aa0abde7 0220-5307 HUMAN OTC DRUG Wyethia helenioides WYETHIA HELENIOIDES ROOT PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron WYETHIA HELENIOIDES ROOT 6 [hp_C]/1 N 20181231 0220-5343_602c4364-1fb8-2fee-e053-2991aa0a758f 0220-5343 HUMAN OTC DRUG X-ray ALCOHOL, X-RAY EXPOSED (1000 RAD) PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ALCOHOL, X-RAY EXPOSED (1000 RAD) 12 [hp_C]/1 N 20181231 0220-5465_60146b3e-85cc-28c6-e053-2a91aa0a4337 0220-5465 HUMAN OTC DRUG Zincum metallicum ZINC PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ZINC 8 [hp_X]/1 N 20181231 0220-6413_5f9b8853-f8b2-3326-e053-2991aa0aa54d 0220-6413 HUMAN PRESCRIPTION DRUG Candida albicans CANDIDA ALBICANS PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CANDIDA ALBICANS 8 [hp_X]/1 Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0220-7309_dd0e7e90-bf6b-11e7-821c-424c58303031 0220-7309 HUMAN PRESCRIPTION DRUG Medorrhinum GONORRHEAL URETHRAL SECRETION HUMAN PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron GONORRHEAL URETHRAL SECRETION HUMAN 12 [hp_X]/1 N 20181231 0220-7604_5fdb33ec-089f-2754-e053-2991aa0a9855 0220-7604 HUMAN PRESCRIPTION DRUG Psorinum SCABIES LESION LYSATE (HUMAN) PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SCABIES LESION LYSATE (HUMAN) 7 [hp_X]/1 N 20181231 0220-7609_4ee1b8a0-bf64-11e7-81fc-424c58303031 0220-7609 HUMAN PRESCRIPTION DRUG Pyrogenium RANCID BEEF PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron RANCID BEEF 8 [hp_X]/1 N 20181231 0220-7796_602c4ad6-79dd-5237-e053-2a91aa0acb1d 0220-7796 HUMAN PRESCRIPTION DRUG Streptococcinum STREPTOCOCCUS PYOGENES PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron STREPTOCOCCUS PYOGENES 12 [hp_X]/1 N 20181231 0220-7935_602c6e08-5802-59fb-e053-2991aa0a3c2d 0220-7935 HUMAN PRESCRIPTION DRUG Tuberculinum TUBERCULIN PURIFIED PROTEIN DERIVATIVE PELLET ORAL 19830303 UNAPPROVED HOMEOPATHIC Laboratoires Boiron TUBERCULIN PURIFIED PROTEIN DERIVATIVE 8 [hp_X]/1 Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [Chemical/Ingredient] N 20181231 0220-9000_5e097970-de38-d9cf-e053-2991aa0a2dd0 0220-9000 HUMAN OTC DRUG Arnicare ARNICA MONTANA GEL TOPICAL 20070109 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA 1 [hp_X]/g N 20181231 0220-9004_5d168e3a-fbc3-3537-e053-2991aa0a3f37 0220-9004 HUMAN OTC DRUG Acidil PICEA MARIANA RESIN, ACTIVATED CHARCOAL, STRYCHNOS NUX-VOMICA SEED, ROBINIA PSEUDOACACIA BARK TABLET ORAL 19970805 UNAPPROVED HOMEOPATHIC Laboratoires Boiron PICEA MARIANA RESIN; ACTIVATED CHARCOAL; STRYCHNOS NUX-VOMICA SEED; ROBINIA PSEUDOACACIA BARK 4; 4; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9013_5d547e34-9a05-ecac-e053-2a91aa0a8c49 0220-9013 HUMAN OTC DRUG Avenoc HORSE CHESTNUT, COLLINSONIA CANADENSIS ROOT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK OINTMENT TOPICAL 20070602 UNAPPROVED HOMEOPATHIC Laboratoires Boiron HORSE CHESTNUT; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 0220-9015_cb7e93e7-5fb4-4a98-a78a-9a7f276f2a32 0220-9015 HUMAN OTC DRUG Avenoc HORSE CHESTNUT, COLLINSONIA CANADENSIS ROOT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK SUPPOSITORY RECTAL 20030224 UNAPPROVED HOMEOPATHIC Laboratoires Boiron HORSE CHESTNUT; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 0220-9021_5df6fef0-4e2b-9cb8-e053-2a91aa0a21e5 0220-9021 HUMAN OTC DRUG ARNICARE ARNICA MONTANA CREAM TOPICAL 20160229 UNAPPROVED HOMEOPATHIC Boiron ARNICA MONTANA 1 [hp_X]/g N 20181231 0220-9021_5df948af-ddd0-71e8-e053-2a91aa0a0236 0220-9021 HUMAN OTC DRUG ARNICARE ARNICA MONTANA CREAM TOPICAL 20070301 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA 1 [hp_X]/g N 20181231 0220-9023_5e0926f8-a02f-ffd9-e053-2991aa0a41e4 0220-9023 HUMAN OTC DRUG Arnicare ARNICA MONTANA OINTMENT CUTANEOUS 20070602 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA 1 [hp_X]/g N 20181231 0220-9032_5e21c1ac-9459-36f7-e053-2a91aa0a539f 0220-9032 HUMAN OTC DRUG Chestal ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA SYRUP ORAL 19930201 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BRYONIA ALBA ROOT; PROTORTONIA CACTI; DROSERA ROTUNDIFOLIA FLOWERING TOP; IPECAC; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; LOBARIA PULMONARIA; ANTIMONY POTASSIUM TARTRATE 3; 3; 3; 3; 6; 6; 3; 3; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 0220-9033_5e3127cd-3e2d-4515-e053-2991aa0a06e8 0220-9033 HUMAN OTC DRUG Chestal for Children ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA SYRUP ORAL 19960801 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BRYONIA ALBA ROOT; PROTORTONIA CACTI; DROSERA ROTUNDIFOLIA FLOWERING TOP; IPECAC; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; LOBARIA PULMONARIA; ANTIMONY POTASSIUM TARTRATE 3; 3; 3; 3; 6; 6; 3; 3; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9042_5e0a2a6f-9062-0bd3-e053-2a91aa0ada8b 0220-9042 HUMAN OTC DRUG Arnicare Value Pack ARNICA MONTANA KIT ORAL; TOPICAL 20081101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron N 20181231 0220-9044_5e09ac62-065b-0859-e053-2991aa0ae0a3 0220-9044 HUMAN OTC DRUG Arnicare Arthritis ARNICA MONTANA, BENZOIC ACID, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, SOLANUM DULCAMARA TOP, POTASSIUM IODIDE, PULSATILLA VULGARIS, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAF TABLET ORAL 20071123 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA; BENZOIC ACID; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; SOLANUM DULCAMARA TOP; POTASSIUM IODIDE; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 3; 6; 6; 12; 6; 12; 3; 12; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9045_5d6bb644-d488-498b-e053-2991aa0a271e 0220-9045 HUMAN OTC DRUG Cocyntal ACTIVATED CHARCOAL, CITRULLUS COLOCYNTHIS FRUIT, COPPER LIQUID ORAL 20110715 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ACTIVATED CHARCOAL; CITRULLUS COLOCYNTHIS FRUIT; COPPER 5; 9; 5 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 0220-9046_c7e4e5c1-d81a-44e1-8903-22fb32b95d41 0220-9046 HUMAN OTC DRUG Arnicare Trauma ARNICA MONTANA, BELLIS PERENNIS, BELLIS PERENNIS PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA; BELLIS PERENNIS; LEDUM PALUSTRE TWIG 9; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 0220-9047_5df6b246-0811-5ca0-e053-2a91aa0a9a27 0220-9047 HUMAN OTC DRUG Arnica Value Pack ARNICA MONTANA KIT 20081101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron N 20181231 0220-9048_5e321011-df49-ff8b-e053-2a91aa0a8ffa 0220-9048 HUMAN OTC DRUG Coldcalm ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, DICHROMATE ION TABLET ORAL 19950101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ONION; APIS MELLIFERA; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; DICHROMATE ION; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS 3; 6; 6; 3; 6; 6; 3; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9049_5e31c6e6-2d19-5d04-e053-2a91aa0a4020 0220-9049 HUMAN OTC DRUG Children Coldcalm ONION, APIS MELLIFERA, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS PELLET ORAL 20080908 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ONION; APIS MELLIFERA; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS 3; 5; 6; 3; 6; 6; 3; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9050_5e0a045a-c056-dd95-e053-2a91aa0a783e 0220-9050 HUMAN OTC DRUG Arnicare Procedure Recovery ARNICA MONTANA KIT ORAL 20071101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron N 20181231 0220-9054_58a2c5cf-0702-4ba3-825f-d1d9f7e5bc60 0220-9054 HUMAN OTC DRUG Camilia MATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOT LIQUID ORAL 20101201 UNAPPROVED HOMEOPATHIC Laboratoires Boiron MATRICARIA RECUTITA; RHUBARB; PHYTOLACCA AMERICANA ROOT 9; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9054_5d67b28a-ef24-d384-e053-2a91aa0a1f95 0220-9054 HUMAN OTC DRUG Camilia MATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOT LIQUID ORAL 20140101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron MATRICARIA RECUTITA; RHUBARB; PHYTOLACCA AMERICANA ROOT 9; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9054_5e21aae5-c6a8-204c-e053-2991aa0a32de 0220-9054 HUMAN OTC DRUG Camilia MATRICARIA RECUTITA, RHUBARB, PHYTOLACCA AMERICANA ROOT LIQUID ORAL 20110715 UNAPPROVED HOMEOPATHIC Laboratoires Boiron MATRICARIA RECUTITA; RHUBARB; PHYTOLACCA AMERICANA ROOT 9; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9057_94afe9a0-2d11-11e7-8190-424c58303031 0220-9057 HUMAN OTC DRUG Coldcalm ONION, APIS MELLIFERA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS LIQUID ORAL 20170501 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ONION; APIS MELLIFERA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS 3; 15; 3; 6; 6; 3; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9059_5e08f3b5-6a5f-bee4-e053-2991aa0a6d52 0220-9059 HUMAN OTC DRUG Arnicare Arnica ARNICA MONTANA TABLET ORAL 20110711 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA 9 [hp_C]/1 N 20181231 0220-9061_7631c280-bf9e-11e7-821a-424c58303031 0220-9061 HUMAN OTC DRUG Childrens Sabadil ONION, AMBROSIA ARTEMISIIFOLIA, HISTAMINE DIHYDROCHLORIDE, SCHOENOCAULON OFFICINALE SEED, EUPHRASIA STRICTA, SOLIDAGO VIRGAUREA FLOWERING TOP PELLET ORAL 20100119 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ONION; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; SCHOENOCAULON OFFICINALE SEED; EUPHRASIA STRICTA; SOLIDAGO VIRGAUREA FLOWERING TOP 5; 5; 9; 5; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9062_5a6ec4c5-8285-4385-b810-fe68850dfb97 0220-9062 HUMAN OTC DRUG Chestal Child Berry ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA SYRUP ORAL 20110601 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BRYONIA ALBA ROOT; PROTORTONIA CACTI; DROSERA ROTUNDIFOLIA; IPECAC; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; LOBARIA PULMONARIA; ANTIMONY POTASSIUM TARTRATE 3; 3; 3; 3; 6; 6; 3; 3; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 0220-9063_79619fb5-88e1-4139-8e99-5a5ce147b09e 0220-9063 HUMAN OTC DRUG Chestal Berry ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA SYRUP ORAL 20110601 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BRYONIA ALBA ROOT; PROTORTONIA CACTI; DROSERA ROTUNDIFOLIA; IPECAC; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; LOBARIA PULMONARIA; ANTIMONY POTASSIUM TARTRATE 3; 3; 3; 3; 6; 6; 3; 3; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 0220-9067_5e31259a-6838-9820-e053-2991aa0a1ebe 0220-9067 HUMAN OTC DRUG Chestal Cough and Cold SOLANUM DULCAMARA TOP, FERRUM PHOSPHORICUM, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED SYRUP ORAL 20130601 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SOLANUM DULCAMARA TOP; FERRUM PHOSPHORICUM; GOLDENSEAL; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED 5; 9; 9; 9; 9 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 0220-9068_5e31155e-9c2b-3b7f-e053-2a91aa0a01cc 0220-9068 HUMAN OTC DRUG Chestal Childrens Cough and Cold SOLANUM DULCAMARA TOP, FERRUM PHOSPHORICUM, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED SYRUP ORAL 20130601 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SOLANUM DULCAMARA TOP; FERRUM PHOSPHORICUM; GOLDENSEAL; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED 5; 9; 9; 9; 9 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 0220-9070_5d6c0724-a961-a32a-e053-2a91aa0a1684 0220-9070 HUMAN OTC DRUG Acteane ARNICA MONTANA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SANGUINARIA CANADENSIS ROOT TABLET ORAL 20150901 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA; BLACK COHOSH; NITROGLYCERIN; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT 4; 4; 4; 5; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9075_5d547e34-99f1-ecac-e053-2a91aa0a8c49 0220-9075 HUMAN OTC DRUG Avenoc HORSE CHESTNUT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, PAEONIA OFFICINALIS ROOT, KRAMERIA LAPPACEA ROOT SUPPOSITORY RECTAL 20160901 UNAPPROVED HOMEOPATHIC Laboratoires Boiron HORSE CHESTNUT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT 7; 2; 2; 7 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 0220-9078_5e32d3bf-5d6e-5172-e053-2991aa0a3892 0220-9078 HUMAN OTC DRUG Cyclease Cramp BLACK COHOSH, CITRULLUS COLOCYNTHIS FRUIT PULP, ESIUM PHOSPHATE, DIBASIC TRIHYDRATE TABLET ORAL 19920708 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9081_5e32b283-33e0-2360-e053-2a91aa0a067b 0220-9081 HUMAN OTC DRUG Cyclease PMS ESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICE TABLET ORAL 20020812 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ESTRONE; SODIUM CHLORIDE; SEPIA OFFICINALIS JUICE 15; 12; 12 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9084_5d54ecda-b142-7895-e053-2991aa0ad1d5 0220-9084 HUMAN OTC DRUG Arnicare Bruise ARNICA MONTANA GEL TOPICAL 20160201 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA 1 [hp_X]/g N 20181231 0220-9086_5d55e918-98a8-4989-e053-2a91aa0a9ad7 0220-9086 HUMAN OTC DRUG CALENDULA CALENDULA OINTMENT TOPICAL 20160129 UNAPPROVED HOMEOPATHIC Boiron CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g N 20181231 0220-9131_35934bf3-7d2d-4147-9c87-276118d7749d 0220-9131 HUMAN OTC DRUG Flu Relief CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE PELLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/g N 20181231 0220-9134_5e32d7fc-1074-4a63-e053-2a91aa0a54fe 0220-9134 HUMAN OTC DRUG Gasalia ACTIVATED CHARCOAL, LYCOPODIUM CLAVATUM SPORE, NUTMEG, DAIKON TABLET ORAL 19970805 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; NUTMEG; DAIKON 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9214_41986c00-bf70-11e7-81f4-424c58303031 0220-9214 HUMAN OTC DRUG Jet Lag Relief ANAMIRTA COCCULUS SEED, ARNICA MONTANA, STRYCHNOS NUX-VOMICA WHOLE PELLET ORAL 20170101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ANAMIRTA COCCULUS SEED; ARNICA MONTANA; STRYCHNOS NUX-VOMICA WHOLE 6; 6; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9228_07f93d60-bf90-11e7-81d1-424c58303031 0220-9228 HUMAN OTC DRUG Leg Pain Relief ZINC, COPPER, HYPERICUM PERFORATUM PELLET ORAL 20170101 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ZINC; COPPER; HYPERICUM PERFORATUM 6; 6; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9277_5e336cf2-3f38-d303-e053-2a91aa0a5fd8 0220-9277 HUMAN OTC DRUG Optique 1 JACOBAEA MARITIMA, EUPHRASIA STRICTA, CALENDULA OFFICINALIS FLOWERING TOP, POTASSIUM CHLORIDE, SILICON DIOXIDE, CALCIUM FLUORIDE, MAGNESIUM CARBONATE LIQUID ORAL 19950717 UNAPPROVED HOMEOPATHIC Laboratoires Boiron JACOBAEA MARITIMA; EUPHRASIA STRICTA; CALENDULA OFFICINALIS FLOWERING TOP; POTASSIUM CHLORIDE; SILICON DIOXIDE; CALCIUM FLUORIDE; MAGNESIUM CARBONATE 6; 9; 4; 10; 10; 10; 10 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 0220-9280_5e33cfd3-5c6b-1a87-e053-2a91aa0ad7a3 0220-9280 HUMAN OTC DRUG Oscillococcinum CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE PELLET ORAL 19980801 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/1 N 20181231 0220-9281_16ab4295-4fb0-4be9-b09f-3baedd7a1748 0220-9281 HUMAN OTC DRUG Children Oscillococcinum CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE PELLET ORAL 20080901 UNAPPROVED HOMEOPATHIC Laboratoires Boiron CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/1 E 20171231 0220-9313_7e740dea-91bd-4f42-97f0-e167e5110b42 0220-9313 HUMAN OTC DRUG Quietude HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM TABLET ORAL 19910613 UNAPPROVED HOMEOPATHIC Laboratoires Boiron HYOSCYAMUS NIGER; NUTMEG; PASSIFLORA INCARNATA TOP; DATURA STRAMONIUM 3; 4; 3; 6 [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1 E 20171231 0220-9314_5d562705-1fe9-5b1a-e053-2991aa0a7f2e 0220-9314 HUMAN OTC DRUG Quietude HYOSCYAMUS NIGER, NUTMEG, PASSIFLORA INCARNATA TOP, DATURA STRAMONIUM TABLET ORAL 20131001 UNAPPROVED HOMEOPATHIC Laboratoires Boiron HYOSCYAMUS NIGER; NUTMEG; PASSIFLORA INCARNATA TOP; DATURA STRAMONIUM 3; 4; 3; 6 [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1 N 20181231 0220-9321_5d55f64d-6243-c895-e053-2a91aa0a4284 0220-9321 HUMAN OTC DRUG Roxalia ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED TABLET ORAL 20131001 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA; ARISAEMA TRIPHYLLUM ROOT; BELLADONNA LEAF; BROMINE; BRYONIA ALBA ROOT; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED 3; 3; 3; 3; 3; 4; 3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9322_6d6aa631-eb45-4f87-8562-b537762aee9f 0220-9322 HUMAN OTC DRUG Roxalia ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, PHYTOLACCA AMERICANA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED TABLET ORAL 19970901 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA; ARISAEMA TRIPHYLLUM ROOT; BELLADONNA LEAF; BROMINE; BRYONIA ALBA ROOT; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; PHYTOLACCA AMERICANA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 3; 3; 3; 3; 3; 3; 3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 0220-9324_5d56a51e-59b5-28ae-e053-2a91aa0ab805 0220-9324 HUMAN OTC DRUG Sabadil ONION, AMBROSIA ARTEMISIIFOLIA, HISTAMINE DIHYDROCHLORIDE, EUPHRASIA STRICTA, SCHOENOCAULON OFFICINALE SEED, SOLIDAGO VIRGAUREA TABLET ORAL 19970901 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ONION; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP 5; 5; 9; 5; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9325_94afe9a0-2d11-11e7-818e-424c58303031 0220-9325 HUMAN OTC DRUG ThroatCalm ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED TABLET ORAL 20170501 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA; ARISAEMA TRIPHYLLUM ROOT; BELLADONNA LEAF; BROMINE; BRYONIA ALBA ROOT; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED 3; 3; 3; 3; 3; 4; 3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9332_5e342c55-af2f-216c-e053-2991aa0a1a8f 0220-9332 HUMAN OTC DRUG Sedalia ACONITUM NAPELLUS, BELLADONNA LEAF, CALENDULA OFFICINALIS FLOWERING TOP, CHELIDONIUM MAJUS, ABRUS PRECATORIUS SEED, VIBURNUM OPULUS ROOT TABLET ORAL 19970705 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ACONITUM NAPELLUS; BELLADONNA LEAF; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; ABRUS PRECATORIUS SEED; VIBURNUM OPULUS BARK 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9341_5e344b14-1b5d-9e93-e053-2a91aa0ac510 0220-9341 HUMAN OTC DRUG Sinusalia BELLADONNA LEAF, SANGUINARIA CANADENSIS ROOT, SPIGELIA TABLET ORAL 20110401 UNAPPROVED HOMEOPATHIC Laboratoires Boiron BELLADONNA LEAF; SANGUINARIA CANADENSIS ROOT; SPIGELIA MARILANDICA ROOT 3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 0220-9342_2697f467-cfd3-490c-8111-777662795324 0220-9342 HUMAN OTC DRUG Sinusalia BELLADONNA LEAF, SANGUINARIA CANADENSIS ROOT, SPIGELIA TABLET ORAL 19970901 UNAPPROVED HOMEOPATHIC Labratoires Boiron BELLADONNA LEAF; SANGUINARIA CANADENSIS ROOT; SPIGELIA 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 0220-9343_6572278f-c06a-44c7-bb44-a2ab5c9dd9e7 0220-9343 HUMAN OTC DRUG Sinusalia ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA PELLET ORAL 20080908 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ATROPA BELLADONNA; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 0220-9346_8e88415c-3c39-4cb4-bb35-407ac8212f5b 0220-9346 HUMAN OTC DRUG Sinusalia ATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, SPIGELIA ANTHELMIA PELLET ORAL 20111201 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ATROPA BELLADONNA; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA 3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 0220-9352_7de8f42c-87e6-4ebe-9841-977a67bc12a7 0220-9352 HUMAN OTC DRUG Sportenine ARNICA MONTANA, LACTIC ACID, L-, ZINC OXIDE TABLET ORAL 19870221 UNAPPROVED HOMEOPATHIC Laboratoires Boiron ARNICA MONTANA; LACTIC ACID, L-; ZINC OXIDE 9; 6; 6 [hp_C]/1; [hp_X]/1; [hp_X]/1 E 20171231 0220-9356_5e35616f-b058-0f18-e053-2991aa0a5749 0220-9356 HUMAN OTC DRUG Thuja occidentalis 30C THUJA OCCIDENTALIS PELLET ORAL 20170315 UNAPPROVED HOMEOPATHIC Boiron THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_C]/30[hp_C] N 20181231 0220-9374_6d272807-1f81-4ea9-b624-855295d2908d 0220-9374 HUMAN OTC DRUG Yeastaway SODIUM BORATE, CALENDULA OFFICINALIS FLOWERING TOP, CANDIDA ALBICANS, GOLDENSEAL SUPPOSITORY VAGINAL 19920708 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SODIUM BORATE; CALENDULA OFFICINALIS FLOWERING TOP; CANDIDA ALBICANS; GOLDENSEAL 14; 1; 30; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 0220-9375_5d565cbc-872a-41dc-e053-2991aa0a6787 0220-9375 HUMAN OTC DRUG Yeastaway SODIUM BORATE, CALENDULA OFFICINALIS FLOWERING TOP, CANDIDA ALBICANS, GOLDENSEAL SUPPOSITORY VAGINAL 20160901 UNAPPROVED HOMEOPATHIC Laboratoires Boiron SODIUM BORATE; CALENDULA OFFICINALIS FLOWERING TOP; CANDIDA ALBICANS; GOLDENSEAL 14; 1; 30; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 0224-0500_61839182-b617-6b46-e053-2a91aa0a78e3 0224-0500 HUMAN OTC DRUG KONSYL Daily Therapy Fiber CALCIUM POLYCARBOPHIL TABLET ORAL 20120312 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 0224-1801_6183b659-6dec-2977-e053-2991aa0aeba5 0224-1801 HUMAN OTC DRUG KONSYL Original Formula Psyllium Fiber PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 6 g/6g N 20181231 0224-1822_6183b659-6dfc-2977-e053-2991aa0aeba5 0224-1822 HUMAN OTC DRUG Konsyl Naturally Sweetened Psyllium Fiber PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 3.4 g/6.5g N 20181231 0224-1841_6183b659-6e0c-2977-e053-2991aa0aeba5 0224-1841 HUMAN OTC DRUG KONSYL Orange Flavor Psyllium Fiber - Original Texture PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 3.4 g/11g N 20181231 0224-1847_6183b659-6e19-2977-e053-2991aa0aeba5 0224-1847 HUMAN OTC DRUG KONSYL 100 Percent Natural Psyllium Fiber PSYLLIUM HUSK CAPSULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 20 mg/1 N 20181231 0224-1852_6183f62c-3074-0d74-e053-2a91aa0a7be3 0224-1852 HUMAN OTC DRUG Konsyl Orange Flavor Psyllium Fiber - Smooth Texture PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 3.4 g/12g N 20181231 0224-1855_6183b659-6e37-2977-e053-2991aa0aeba5 0224-1855 HUMAN OTC DRUG KONSYL Sugar Free Orange Flavor Psyllium Fiber PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 3.5 g/5.8g N 20181231 0224-1856_6183b659-6e47-2977-e053-2991aa0aeba5 0224-1856 HUMAN OTC DRUG KONSYL Easy Mix Formula Psyllium Fiber PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 4.3 g/6g N 20181231 0224-1860_6183f62c-3052-0d74-e053-2a91aa0a7be3 0224-1860 HUMAN OTC DRUG Konsyl Overnight Relief Senna Prompt PLANTAGO SEED, SENNOSIDES CAPSULE ORAL 20110401 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PLANTAGO SEED; SENNOSIDES 500; 9 mg/1; mg/1 N 20181231 0224-1866_6183f62c-3064-0d74-e053-2a91aa0a7be3 0224-1866 HUMAN OTC DRUG KONSYL Sugar Free Orange Flavor Psyllium Fiber Psyllium Hydrophilic Mucilloid GRANULE ORAL 20130620 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 3.5 g/5.8g N 20181231 0224-1878_0463cfa6-6519-4540-969a-93491b5713fd 0224-1878 HUMAN OTC DRUG KONSYL ORANGE EXTRA STRENGTH FORMULA PSYLLIUM HUSK GRANULE ORAL 20150224 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc. PSYLLIUM HUSK 6 g/9g E 20171231 0224-1879_6184042c-45cb-4caa-e053-2a91aa0aee69 0224-1879 HUMAN OTC DRUG Konsyl Orange Extra Strength Formula PSYLLIUM HUSK POWDER TOPICAL 20151217 OTC MONOGRAPH NOT FINAL part334 Konsyl Pharmaceuticals, Inc PSYLLIUM HUSK 60 mg/g N 20181231 0225-0295_5b5d2c46-5cd4-c6ef-e053-2991aa0adf32 0225-0295 HUMAN PRESCRIPTION DRUG ANASPAZ HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING ORAL; SUBLINGUAL 19730102 UNAPPROVED DRUG OTHER BF ASCHER AND CO INC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 0225-0360_5fb1a855-c306-45f1-e053-2a91aa0a0371 0225-0360 HUMAN OTC DRUG MOBISYL TROLAMINE SALICYLATE CREAM TOPICAL 20140919 OTC MONOGRAPH NOT FINAL part348 BF ASCHER AND CO INC TROLAMINE SALICYLATE 10 g/100g N 20181231 0225-0495_03c16d33-8f5a-0184-e054-00144ff8d46c 0225-0495 HUMAN OTC DRUG ITCH X BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE GEL TOPICAL 20140919 OTC MONOGRAPH NOT FINAL part348 BF ASCHER AND CO INC BENZYL ALCOHOL; PRAMOXINE HYDROCHLORIDE 10; 1 g/100g; g/100g N 20181231 0225-0516_3fb1e4d3-8e24-2227-e054-00144ff8d46c 0225-0516 HUMAN OTC DRUG ITCH-X PRAMOXINE HCL/BENZYL ALCOHOL SPRAY TOPICAL 20140919 OTC MONOGRAPH NOT FINAL part348 BF ASCHER AND CO INC PRAMOXINE HYDROCHLORIDE; BENZYL ALCOHOL 1; 10 g/100mL; g/100mL N 20181231 0225-0610_03e598d8-8da9-2dd0-e054-00144ff88e88 0225-0610 HUMAN OTC DRUG BENZEDREX 09-19-2014 PROPYLHEXEDRINE INHALANT NASAL 20140919 OTC MONOGRAPH FINAL part341 BF ASCHER AND CO INC PROPYLHEXEDRINE 250 mg/1 N 20181231 0228-1410_0bc90555-2657-486e-8e5a-d0f8816015e9 0228-1410 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160401 ANDA ANDA200672 Actavis Pharma, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0228-1422_0bc90555-2657-486e-8e5a-d0f8816015e9 0228-1422 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160401 ANDA ANDA200672 Actavis Pharma, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0228-1435_0bc90555-2657-486e-8e5a-d0f8816015e9 0228-1435 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160401 ANDA ANDA200672 Actavis Pharma, Inc. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0228-1453_0bc90555-2657-486e-8e5a-d0f8816015e9 0228-1453 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160401 ANDA ANDA200672 Actavis Pharma, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0228-1580_0bc90555-2657-486e-8e5a-d0f8816015e9 0228-1580 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160401 ANDA ANDA200672 Actavis Pharma, Inc. LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0228-1638_0bc90555-2657-486e-8e5a-d0f8816015e9 0228-1638 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160601 ANDA ANDA203733 Actavis Pharma, Inc. LAMOTRIGINE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0228-2027_0433ccb1-6c8e-4f66-9ce4-df691f2e13b7 0228-2027 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931001 ANDA ANDA074342 Actavis Pharma, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-2029_0433ccb1-6c8e-4f66-9ce4-df691f2e13b7 0228-2029 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931001 ANDA ANDA074342 Actavis Pharma, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-2031_0433ccb1-6c8e-4f66-9ce4-df691f2e13b7 0228-2031 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931001 ANDA ANDA074342 Actavis Pharma, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-2039_0433ccb1-6c8e-4f66-9ce4-df691f2e13b7 0228-2039 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931001 ANDA ANDA074342 Actavis Pharma, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-2067_f1906304-1f5b-40cf-a211-cecfc3740b74 0228-2067 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070102 ANDA ANDA072251 Actavis Pharma, Inc. OXAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-2069_f1906304-1f5b-40cf-a211-cecfc3740b74 0228-2069 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070102 ANDA ANDA072252 Actavis Pharma, Inc. OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-2073_f1906304-1f5b-40cf-a211-cecfc3740b74 0228-2073 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070102 ANDA ANDA072253 Actavis Pharma, Inc. OXAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-2076_da01f80a-0d63-4a56-96ee-a0c999521ca4 0228-2076 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19900930 ANDA ANDA071620 Actavis Pharma, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0228-2077_da01f80a-0d63-4a56-96ee-a0c999521ca4 0228-2077 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19900930 ANDA ANDA071620 Actavis Pharma, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0228-2127_6e8314c7-c172-4429-8a13-19f2c7ce75e8 0228-2127 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070974 Actavis Pharma, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0228-2128_6e8314c7-c172-4429-8a13-19f2c7ce75e8 0228-2128 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070975 Actavis Pharma, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0228-2129_6e8314c7-c172-4429-8a13-19f2c7ce75e8 0228-2129 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070976 Actavis Pharma, Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0228-2167_eaa14eb1-3ca5-4803-9bf7-8fb5766dd373 0228-2167 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110404 ANDA ANDA090484 Actavis Elizabeth LLC LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 0228-2348_464bb94f-1dbd-42f2-b2b7-a7c9500fdc17 0228-2348 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 20060115 ANDA ANDA080172 Actavis Pharma, Inc. PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 0228-2497_0c7cb72a-2de5-4689-af83-52caa20f5f18 0228-2497 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 19910101 ANDA ANDA072579 Actavis Pharma, Inc. NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0228-2530_0c7cb72a-2de5-4689-af83-52caa20f5f18 0228-2530 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 19900920 ANDA ANDA072556 Actavis Pharma, Inc. NIFEDIPINE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0228-2538_db9521a3-9708-4812-a450-dbdeeb5901a1 0228-2538 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 Actavis Pharma, Inc. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0228-2539_db9521a3-9708-4812-a450-dbdeeb5901a1 0228-2539 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 Actavis Pharma, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0228-2540_db9521a3-9708-4812-a450-dbdeeb5901a1 0228-2540 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 Actavis Pharma, Inc. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0228-2550_67c4a5af-5acf-4c3a-90f1-af9d0add6995 0228-2550 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Actavis Pharma, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0228-2551_67c4a5af-5acf-4c3a-90f1-af9d0add6995 0228-2551 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Actavis Pharma, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0228-2571_97fa4b02-fdbc-4bca-ad10-35bf34c3c4f0 0228-2571 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20070102 ANDA ANDA074722 Actavis Pharma, Inc. INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0228-2597_97fa4b02-fdbc-4bca-ad10-35bf34c3c4f0 0228-2597 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20070102 ANDA ANDA074722 Actavis Pharma, Inc. INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0228-2620_d9d57a54-8ece-445a-be05-c8d6b68b9bef 0228-2620 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 19981030 ANDA ANDA075037 Actavis Pharma, Inc. ISOSORBIDE MONONITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0228-2631_d9d57a54-8ece-445a-be05-c8d6b68b9bef 0228-2631 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 19981030 ANDA ANDA075037 Actavis Pharma, Inc. ISOSORBIDE MONONITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0228-2636_c9abd4df-9d99-4cd1-a26b-462ccf79847e 0228-2636 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20040214 ANDA ANDA075694 Actavis Pharma, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 0228-2637_c9abd4df-9d99-4cd1-a26b-462ccf79847e 0228-2637 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20041004 ANDA ANDA075694 Actavis Pharma, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 0228-2665_6b05ed68-e47b-4bd8-a484-c6e5ea907980 0228-2665 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 20181031 ANDA ANDA075350 Actavis Pharma, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0228-2666_6b05ed68-e47b-4bd8-a484-c6e5ea907980 0228-2666 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 20181130 ANDA ANDA075350 Actavis Pharma, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0228-2667_6b05ed68-e47b-4bd8-a484-c6e5ea907980 0228-2667 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 20181031 ANDA ANDA075350 Actavis Pharma, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0228-2672_176631eb-0989-4674-af4b-5817f76f64b8 0228-2672 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Actavis Pharma, Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0228-2673_176631eb-0989-4674-af4b-5817f76f64b8 0228-2673 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Actavis Pharma, Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0228-2751_0bf10ff9-2970-40f2-ac8e-d13354c1d566 0228-2751 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20050628 ANDA ANDA076716 Actavis Pharma, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0228-2752_0bf10ff9-2970-40f2-ac8e-d13354c1d566 0228-2752 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20050628 ANDA ANDA076716 Actavis Pharma, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0228-2753_0bf10ff9-2970-40f2-ac8e-d13354c1d566 0228-2753 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20050628 ANDA ANDA076716 Actavis Pharma, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0228-2778_d20090de-d314-4632-b557-f65e667786a3 0228-2778 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Actavis Pharma, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0228-2779_d20090de-d314-4632-b557-f65e667786a3 0228-2779 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Actavis Pharma, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0228-2780_d20090de-d314-4632-b557-f65e667786a3 0228-2780 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Actavis Pharma, Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0228-2781_d20090de-d314-4632-b557-f65e667786a3 0228-2781 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Actavis Pharma, Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0228-2801_22abcf90-3c9b-4a03-af84-a1a14257f8c2 0228-2801 HUMAN PRESCRIPTION DRUG Pilocarpine hydrochloride Pilocarpine hydrochloride TABLET, FILM COATED ORAL 20110913 NDA AUTHORIZED GENERIC NDA020237 Actavis Pharma, Inc. PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 0228-2803_176631eb-0989-4674-af4b-5817f76f64b8 0228-2803 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Actavis Pharma, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0228-2820_6b4dd46d-60b4-48af-9c10-049785bc75d0 0228-2820 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070312 ANDA ANDA040707 Actavis Pharma, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0228-2837_22abcf90-3c9b-4a03-af84-a1a14257f8c2 0228-2837 HUMAN PRESCRIPTION DRUG Pilocarpine hydrochloride Pilocarpine hydrochloride TABLET, FILM COATED ORAL 20110913 NDA AUTHORIZED GENERIC NDA020237 Actavis Pharma, Inc. PILOCARPINE HYDROCHLORIDE 7.5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 0228-2838_61552b7b-83cf-46d4-bf3d-e9d40e5d4371 0228-2838 HUMAN PRESCRIPTION DRUG fenofibric acid fenofibric acid CAPSULE, DELAYED RELEASE ORAL 20160121 ANDA ANDA200920 Actavis Pharma, Inc. FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0228-2839_61552b7b-83cf-46d4-bf3d-e9d40e5d4371 0228-2839 HUMAN PRESCRIPTION DRUG fenofibric acid fenofibric acid CAPSULE, DELAYED RELEASE ORAL 20160121 ANDA ANDA200920 Actavis Pharma, Inc. FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0228-2848_d956bc30-dee8-48e1-b471-3b5d47735ba8 0228-2848 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE ORAL 20140805 ANDA ANDA091482 Actavis Pharma, Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0228-2849_d956bc30-dee8-48e1-b471-3b5d47735ba8 0228-2849 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE ORAL 20140805 ANDA ANDA091482 Actavis Pharma, Inc. FLUVOXAMINE MALEATE 150 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0228-2850_4751eb56-a4ae-4324-a516-84db9359a664 0228-2850 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20141201 ANDA ANDA200881 Actavis Pharma, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0228-2851_4751eb56-a4ae-4324-a516-84db9359a664 0228-2851 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20141201 ANDA ANDA200881 Actavis Pharma, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0228-2853_4751eb56-a4ae-4324-a516-84db9359a664 0228-2853 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20141201 ANDA ANDA200881 Actavis Pharma, Inc. GUANFACINE HYDROCHLORIDE 3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0228-2855_4751eb56-a4ae-4324-a516-84db9359a664 0228-2855 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20141201 ANDA ANDA200881 Actavis Pharma, Inc. GUANFACINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0228-2876_103fa609-278d-460d-b475-a4afe70b2a25 0228-2876 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20150820 ANDA ANDA076636 Actavis Pharma, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-2878_103fa609-278d-460d-b475-a4afe70b2a25 0228-2878 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110607 ANDA ANDA076636 Actavis Pharma, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-2879_103fa609-278d-460d-b475-a4afe70b2a25 0228-2879 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110523 ANDA ANDA076636 Actavis Pharma, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-2890_1119af19-2e95-4001-a7b1-494694f9ff68 0228-2890 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20131217 ANDA ANDA090776 Actavis Pharma, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0228-2891_1119af19-2e95-4001-a7b1-494694f9ff68 0228-2891 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20131217 ANDA ANDA090776 Actavis Pharma, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0228-2892_1119af19-2e95-4001-a7b1-494694f9ff68 0228-2892 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20131217 ANDA ANDA090776 Actavis Pharma, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0228-2895_1b056045-72d4-4784-9589-08222b50cbf2 0228-2895 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20131101 ANDA ANDA090134 Actavis Pharma, Inc. DOXYCYCLINE HYCLATE 75 mg/1 N 20181231 0228-2896_1b056045-72d4-4784-9589-08222b50cbf2 0228-2896 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20131028 ANDA ANDA090134 Actavis Pharma, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0228-2918_09e4317d-558d-485c-8e71-6c0c994058f3 0228-2918 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20131125 ANDA ANDA202463 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0228-2981_e3bd05b2-ed2b-44b7-82fd-019080c4a746 0228-2981 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131210 ANDA ANDA201447 Actavis Pharma, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-2982_e3bd05b2-ed2b-44b7-82fd-019080c4a746 0228-2982 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131127 ANDA ANDA201447 Actavis Pharma, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-2983_e3bd05b2-ed2b-44b7-82fd-019080c4a746 0228-2983 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131127 ANDA ANDA201447 Actavis Pharma, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-2996_cf0c0ad6-c1d5-4314-a600-2731edb79116 0228-2996 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 Actavis Pharma, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 0228-3003_c7030fd0-0449-4cfa-a979-2ebbc2d49dde 0228-3003 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970212 ANDA ANDA074869 Actavis Pharma, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-3004_c7030fd0-0449-4cfa-a979-2ebbc2d49dde 0228-3004 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970212 ANDA ANDA074869 Actavis Pharma, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-3005_c7030fd0-0449-4cfa-a979-2ebbc2d49dde 0228-3005 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970212 ANDA ANDA074869 Actavis Pharma, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-3046_bcf1ef2d-ed81-4bd3-8fcc-97619d7a1ebc 0228-3046 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20160205 20180331 ANDA ANDA206340 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0228-3047_bcf1ef2d-ed81-4bd3-8fcc-97619d7a1ebc 0228-3047 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20160205 20180331 ANDA ANDA206340 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0228-3048_bcf1ef2d-ed81-4bd3-8fcc-97619d7a1ebc 0228-3048 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20160205 20180331 ANDA ANDA206340 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0228-3049_bcf1ef2d-ed81-4bd3-8fcc-97619d7a1ebc 0228-3049 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20160205 20180331 ANDA ANDA206340 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0228-3050_bcf1ef2d-ed81-4bd3-8fcc-97619d7a1ebc 0228-3050 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20160205 20180331 ANDA ANDA206340 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0228-3051_bcf1ef2d-ed81-4bd3-8fcc-97619d7a1ebc 0228-3051 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20160205 20180430 ANDA ANDA206340 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0228-3052_bcf1ef2d-ed81-4bd3-8fcc-97619d7a1ebc 0228-3052 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20160205 20180430 ANDA ANDA206340 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0228-3059_071a7dfa-9c58-4d50-82eb-6b657fcec620 0228-3059 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120622 ANDA ANDA077302 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0228-3060_071a7dfa-9c58-4d50-82eb-6b657fcec620 0228-3060 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120622 ANDA ANDA077302 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0228-3061_071a7dfa-9c58-4d50-82eb-6b657fcec620 0228-3061 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120622 ANDA ANDA077302 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0228-3062_071a7dfa-9c58-4d50-82eb-6b657fcec620 0228-3062 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120622 ANDA ANDA077302 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0228-3063_071a7dfa-9c58-4d50-82eb-6b657fcec620 0228-3063 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120622 ANDA ANDA077302 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0228-3064_071a7dfa-9c58-4d50-82eb-6b657fcec620 0228-3064 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120622 ANDA ANDA077302 Actavis Pharma, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0228-3083_ffdc91be-d93c-4645-b626-600bb708ba91 0228-3083 HUMAN PRESCRIPTION DRUG Alprazolam Extended Release Alprazolam TABLET, EXTENDED RELEASE ORAL 20070312 ANDA ANDA078056 Actavis Pharma, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-3084_ffdc91be-d93c-4645-b626-600bb708ba91 0228-3084 HUMAN PRESCRIPTION DRUG Alprazolam Extended Release Alprazolam TABLET, EXTENDED RELEASE ORAL 20070312 ANDA ANDA078056 Actavis Pharma, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-3086_ffdc91be-d93c-4645-b626-600bb708ba91 0228-3086 HUMAN PRESCRIPTION DRUG Alprazolam Extended Release Alprazolam TABLET, EXTENDED RELEASE ORAL 20070312 ANDA ANDA078056 Actavis Pharma, Inc. ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-3087_ffdc91be-d93c-4645-b626-600bb708ba91 0228-3087 HUMAN PRESCRIPTION DRUG Alprazolam Extended Release Alprazolam TABLET, EXTENDED RELEASE ORAL 20070312 ANDA ANDA078056 Actavis Pharma, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-3090_a481f393-e436-4788-93d1-247b155d3f4b 0228-3090 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140204 ANDA ANDA079040 Actavis Pharma, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3091_a481f393-e436-4788-93d1-247b155d3f4b 0228-3091 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140204 ANDA ANDA079040 Actavis Pharma, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3092_a481f393-e436-4788-93d1-247b155d3f4b 0228-3092 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140204 ANDA ANDA079040 Actavis Pharma, Inc. MORPHINE SULFATE 90 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3093_a481f393-e436-4788-93d1-247b155d3f4b 0228-3093 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140204 ANDA ANDA079040 Actavis Pharma, Inc. MORPHINE SULFATE 120 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3116_a481f393-e436-4788-93d1-247b155d3f4b 0228-3116 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140204 ANDA ANDA079040 Actavis Pharma, Inc. MORPHINE SULFATE 45 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3117_a481f393-e436-4788-93d1-247b155d3f4b 0228-3117 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140204 ANDA ANDA079040 Actavis Pharma, Inc. MORPHINE SULFATE 75 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3153_e3a43930-94b7-40da-b5a1-4587553942e3 0228-3153 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine TABLET SUBLINGUAL 20150219 ANDA ANDA090819 Actavis Pharma, Inc. BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 0228-3154_40270c4a-8c58-4f34-a6ef-4386519007ff 0228-3154 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone Buprenorphine and Naloxone TABLET SUBLINGUAL 20130305 ANDA ANDA091422 Actavis Pharma, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 0228-3155_40270c4a-8c58-4f34-a6ef-4386519007ff 0228-3155 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone Buprenorphine and Naloxone TABLET SUBLINGUAL 20130305 ANDA ANDA091422 Actavis Pharma, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 0228-3156_e3a43930-94b7-40da-b5a1-4587553942e3 0228-3156 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine TABLET SUBLINGUAL 20150219 ANDA ANDA090819 Actavis Pharma, Inc. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 0228-3227_d48a0a4b-0784-4a73-a9a9-663e70b74bbd 0228-3227 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Pharma, Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3228_d48a0a4b-0784-4a73-a9a9-663e70b74bbd 0228-3228 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Pharma, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3229_d48a0a4b-0784-4a73-a9a9-663e70b74bbd 0228-3229 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Pharma, Inc. OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3230_d48a0a4b-0784-4a73-a9a9-663e70b74bbd 0228-3230 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Pharma, Inc. OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3261_d48a0a4b-0784-4a73-a9a9-663e70b74bbd 0228-3261 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Pharma, Inc. OXYMORPHONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3262_d48a0a4b-0784-4a73-a9a9-663e70b74bbd 0228-3262 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Pharma, Inc. OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3263_d48a0a4b-0784-4a73-a9a9-663e70b74bbd 0228-3263 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Actavis Pharma, Inc. OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3481_ddcce7b8-36f6-40e5-959c-bbed9ea73114 0228-3481 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101014 ANDA ANDA078179 Actavis Pharma, Inc. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0228-3482_ddcce7b8-36f6-40e5-959c-bbed9ea73114 0228-3482 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110606 ANDA ANDA078179 Actavis Pharma, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0228-3501_65da2762-ccbf-4d36-9e65-d32a54c41f0a 0228-3501 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3502_65da2762-ccbf-4d36-9e65-d32a54c41f0a 0228-3502 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3503_65da2762-ccbf-4d36-9e65-d32a54c41f0a 0228-3503 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3504_65da2762-ccbf-4d36-9e65-d32a54c41f0a 0228-3504 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3505_65da2762-ccbf-4d36-9e65-d32a54c41f0a 0228-3505 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3506_65da2762-ccbf-4d36-9e65-d32a54c41f0a 0228-3506 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3507_65da2762-ccbf-4d36-9e65-d32a54c41f0a 0228-3507 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3508_65da2762-ccbf-4d36-9e65-d32a54c41f0a 0228-3508 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111111 NDA AUTHORIZED GENERIC NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-3640_0f9160fd-d3f3-400f-85ea-c901eb2d8089 0228-3640 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120823 ANDA ANDA090869 Actavis Pharma, Inc. ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0228-3658_0f9160fd-d3f3-400f-85ea-c901eb2d8089 0228-3658 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120823 ANDA ANDA090869 Actavis Pharma, Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0228-3659_0f9160fd-d3f3-400f-85ea-c901eb2d8089 0228-3659 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120823 ANDA ANDA090869 Actavis Pharma, Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0228-3660_0f9160fd-d3f3-400f-85ea-c901eb2d8089 0228-3660 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120823 ANDA ANDA090869 Actavis Pharma, Inc. ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0228-3661_0f9160fd-d3f3-400f-85ea-c901eb2d8089 0228-3661 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120823 ANDA ANDA090869 Actavis Pharma, Inc. ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0228-4019_6db1d27f-513b-4cf1-a72a-6e1583a52d20 0228-4019 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20100317 ANDA ANDA078561 Actavis Pharma, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-4022_6db1d27f-513b-4cf1-a72a-6e1583a52d20 0228-4022 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20100317 ANDA ANDA078561 Actavis Pharma, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-4024_6db1d27f-513b-4cf1-a72a-6e1583a52d20 0228-4024 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20100317 ANDA ANDA078561 Actavis Pharma, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-4025_6db1d27f-513b-4cf1-a72a-6e1583a52d20 0228-4025 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20100317 ANDA ANDA078561 Actavis Pharma, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0228-4029_1d484ac5-31ac-45e1-bcf4-1fee0e33dbba 0228-4029 HUMAN PRESCRIPTION DRUG Oxycodone hydrochloride and Ibuprofen Oxycodone hydrochloride and Ibuprofen TABLET, FILM COATED ORAL 20081104 ANDA ANDA078769 Actavis Pharma, Inc. OXYCODONE HYDROCHLORIDE; IBUPROFEN 5; 400 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 0228-4241_bf800cc5-4a77-4fe0-8798-1b639848daa8 0228-4241 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20150617 ANDA ANDA203320 Actavis Pharma, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0228-4242_bf800cc5-4a77-4fe0-8798-1b639848daa8 0228-4242 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20150617 ANDA ANDA203320 Actavis Pharma, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0228-4270_1be7094b-e665-4bac-ba85-ad7194b61cd6 0228-4270 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151026 ANDA ANDA203849 Actavis Pharma, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-4271_1be7094b-e665-4bac-ba85-ad7194b61cd6 0228-4271 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151026 ANDA ANDA203849 Actavis Pharma, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-4311_1be7094b-e665-4bac-ba85-ad7194b61cd6 0228-4311 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151026 ANDA ANDA203849 Actavis Pharma, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-4323_1be7094b-e665-4bac-ba85-ad7194b61cd6 0228-4323 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151026 ANDA ANDA203849 Actavis Pharma, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-4347_1be7094b-e665-4bac-ba85-ad7194b61cd6 0228-4347 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151026 ANDA ANDA203849 Actavis Pharma, Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0228-4529_dcd1aa90-33ec-4d51-ab69-a0eb4d503777 0228-4529 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20160204 ANDA ANDA202415 Actavis Pharma, Inc. DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0234-0575_60dd8389-8076-d8a9-e053-2a91aa0a0a2b 0234-0575 HUMAN OTC DRUG Hibiclens Chlorhexidine Gluconate SOLUTION TOPICAL 19760917 NDA NDA017768 Molnlycke Health Care CHLORHEXIDINE GLUCONATE 213 g/1000mL N 20181231 0234-0575_6155acd9-8ec4-a87d-e053-2991aa0a7b43 0234-0575 HUMAN OTC DRUG Hibiclens Chlorhexidine Gluconate SOLUTION TOPICAL 20160215 NDA NDA017768 Molnlycke Health Care CHLORHEXIDINE GLUCONATE 213 g/1000mL N 20181231 0234-0575_6156da61-c637-36d9-e053-2a91aa0afd94 0234-0575 HUMAN OTC DRUG Hibiclens Chlorhexidine Gluconate SOLUTION TOPICAL 19760917 NDA NDA017768 Molnlycke Health Care CHLORHEXIDINE GLUCONATE 213 g/1000mL N 20181231 0234-0587_21c3470f-a2a8-43a4-8b14-7c57e3dd2287 0234-0587 HUMAN OTC DRUG Hibistat Chlorhexidine gluconate and Isopropyl alcohol SOLUTION TOPICAL 19800523 NDA NDA018300 Mölnlycke Health Care US, LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL .525; 70 g/5mL; g/5mL N 20181231 0234-2240_603d10a0-1931-f286-e053-2a91aa0a4fa2 0234-2240 HUMAN OTC DRUG PreviSense Once a Day Moisturizing Cream Dimethicone CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part347 Molnlycke Health Care DIMETHICONE 5 g/100g N 20181231 0234-2240_603e433d-74dd-f542-e053-2991aa0a7148 0234-2240 HUMAN OTC DRUG PreviSense Once a Day Moisturizing Cream Dimethicone CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part347 Molnlycke Health Care DIMETHICONE 5 g/100g N 20181231 0234-8200_603cf1a5-06a7-b45a-e053-2a91aa0a46ab 0234-8200 HUMAN OTC DRUG PreviSense Moisture Barrier Cream Dimethicone 5% CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part347 Molnlycke Health Care DIMETHICONE 5 g/100g N 20181231 0234-8200_603d0553-c153-7383-e053-2991aa0a5e73 0234-8200 HUMAN OTC DRUG PreviSense Moisture Barrier Cream Dimethicone 5% CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part347 Molnlycke Health Care DIMETHICONE 5 g/100g N 20181231 0234-8576_603e7ad8-52ab-0529-e053-2991aa0a3201 0234-8576 HUMAN OTC DRUG PreviSense Moisture Barrier with Protease Technology Zinc Oxide 7.5% CREAM TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Molnlycke Health Care ZINC OXIDE 7.5 g/100g N 20181231 0234-8576_603e9ced-78dd-2f9a-e053-2991aa0a3845 0234-8576 HUMAN OTC DRUG PreviSense Moisture Barrier with Protease Technology Zinc Oxide 7.5% CREAM TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Molnlycke Health Care ZINC OXIDE 7.5 g/100g N 20181231 0234-8578_603e2467-1364-dfad-e053-2991aa0ae7f2 0234-8578 HUMAN OTC DRUG PreviSense Antifungal Moisture Barrier with Protease Technology Miconazole Nitrate 2.0% CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part333C Molnlycke Health Care MICONAZOLE NITRATE 2 g/100g N 20181231 0234-8578_603e2467-1374-dfad-e053-2991aa0ae7f2 0234-8578 HUMAN OTC DRUG PreviSense Antifungal Moisture Barrier with Protease Technology Miconazole Nitrate 2.0% CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part333C Molnlycke Health Care MICONAZOLE NITRATE 2 g/100g N 20181231 0245-0003_decfe387-3b4c-481e-bc51-217d6f9f8b0f 0245-0003 HUMAN PRESCRIPTION DRUG SSKI Potassium Iodide SOLUTION ORAL 19730430 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, LLC POTASSIUM IODIDE 1 g/mL N 20181231 0245-0008_2905a738-af8b-4baa-9c2f-67769897220c 0245-0008 HUMAN PRESCRIPTION DRUG Fortical calcitonin salmon SPRAY, METERED NASAL 20050812 NDA NDA021406 Upsher-Smith Laboratories, Inc. CALCITONIN SALMON 2200 [iU]/mL Calcitonin [Chemical/Ingredient],Calcitonin [EPC] E 20171231 0245-0012_ccbb0602-b626-46b5-8780-9e47d30beae1 0245-0012 HUMAN PRESCRIPTION DRUG Sorine Sotalol Hydrochloride TABLET ORAL 20110215 ANDA ANDA075500 Upsher-Smith Laboratories, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0245-0013_ccbb0602-b626-46b5-8780-9e47d30beae1 0245-0013 HUMAN PRESCRIPTION DRUG Sorine Sotalol Hydrochloride TABLET ORAL 20110215 ANDA ANDA075500 Upsher-Smith Laboratories, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0245-0014_ccbb0602-b626-46b5-8780-9e47d30beae1 0245-0014 HUMAN PRESCRIPTION DRUG Sorine Sotalol Hydrochloride TABLET ORAL 20110215 ANDA ANDA075500 Upsher-Smith Laboratories, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0245-0015_ccbb0602-b626-46b5-8780-9e47d30beae1 0245-0015 HUMAN PRESCRIPTION DRUG Sorine Sotalol Hydrochloride TABLET ORAL 20110215 ANDA ANDA075500 Upsher-Smith Laboratories, Inc. SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0245-0036_1788d34e-a160-474d-a759-65f487dc7634 0245-0036 HUMAN PRESCRIPTION DRUG Prevalite cholestyramine POWDER, FOR SUSPENSION ORAL 19960201 ANDA ANDA073263 Upsher-Smith Laboratories, LLC CHOLESTYRAMINE 4 g/5.5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 0245-0039_213fd739-e9f9-437d-807c-2caf3b8212de 0245-0039 HUMAN PRESCRIPTION DRUG Potassium Bicarbonate Potassium Bicarbonate TABLET, EFFERVESCENT ORAL 20140901 UNAPPROVED DRUG OTHER Upsher-Smith Laboratories, Inc. POTASSIUM BICARBONATE 978 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0245-0040_e8018559-8f6b-4cf3-a581-3b62a2b110c1 0245-0040 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0245-0041_e8018559-8f6b-4cf3-a581-3b62a2b110c1 0245-0041 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0245-0057_ae920aab-2351-4fb4-aa41-c3c7d9bfef45 0245-0057 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0245-0058_ae920aab-2351-4fb4-aa41-c3c7d9bfef45 0245-0058 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0245-0067_a58adb26-0e38-4dcf-870f-233300dd20c1 0245-0067 HUMAN PRESCRIPTION DRUG Niacor Niacin TABLET ORAL 20000503 ANDA ANDA040378 Upsher-Smith Laboratories, LLC NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 0245-0070_65e63e06-e105-4134-b074-5040687bf359 0245-0070 HUMAN PRESCRIPTION DRUG Potassium Citrate potassium citrate TABLET ORAL 20060901 NDA NDA019071 Upsher-Smith Laboratories, LLC POTASSIUM CITRATE 5 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0245-0071_65e63e06-e105-4134-b074-5040687bf359 0245-0071 HUMAN PRESCRIPTION DRUG Potassium Citrate potassium citrate TABLET ORAL 20060901 NDA NDA019071 Upsher-Smith Laboratories, LLC POTASSIUM CITRATE 10 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0245-0084_524d0e3c-2fcd-460c-a7bf-aa6e5dbe1660 0245-0084 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110502 ANDA ANDA078311 Upsher-Smith Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0245-0085_524d0e3c-2fcd-460c-a7bf-aa6e5dbe1660 0245-0085 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110502 ANDA ANDA078311 Upsher-Smith Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0245-0086_524d0e3c-2fcd-460c-a7bf-aa6e5dbe1660 0245-0086 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110502 ANDA ANDA078311 Upsher-Smith Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0245-0087_524d0e3c-2fcd-460c-a7bf-aa6e5dbe1660 0245-0087 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110502 ANDA ANDA078311 Upsher-Smith Laboratories, Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0245-0101_1cf0f8d5-ff63-4977-8d97-b6bb9c881a06 0245-0101 HUMAN PRESCRIPTION DRUG Klor-Con Sprinkle Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20150710 ANDA ANDA203106 Upsher-Smith Laboratories, LLC POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0245-0102_1cf0f8d5-ff63-4977-8d97-b6bb9c881a06 0245-0102 HUMAN PRESCRIPTION DRUG Klor-Con Sprinkle Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20150710 ANDA ANDA203106 Upsher-Smith Laboratories, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0245-0144_2d90d197-683f-4361-b011-d441fbe53846 0245-0144 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20110119 ANDA ANDA075135 Upsher-Smith Laboratories, Inc. AMIODARONE HYDROCHLORIDE 100 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0245-0145_7c5ce47c-8219-49a8-a958-e2b7a7ff68d7 0245-0145 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20000630 ANDA ANDA075315 Upsher-Smith Laboratories, LLC AMIODARONE HYDROCHLORIDE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 0245-0145_874116a0-67ad-40b4-b266-15cb4375b30c 0245-0145 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20000630 ANDA ANDA075315 Upsher-Smith Laboratories, Inc. AMIODARONE HYDROCHLORIDE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 0245-0147_2d90d197-683f-4361-b011-d441fbe53846 0245-0147 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20110119 ANDA ANDA075135 Upsher-Smith Laboratories, Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0245-0150_ae920aab-2351-4fb4-aa41-c3c7d9bfef45 0245-0150 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Upsher-Smith Laboratories, Inc. POTASSIUM CHLORIDE 1125 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0245-0211_4b403bac-d62f-4886-b768-8e824d885187 0245-0211 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20041103 ANDA ANDA076725 Upsher-Smith laboratories, LLC MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0245-0212_4b403bac-d62f-4886-b768-8e824d885187 0245-0212 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20041103 ANDA ANDA076725 Upsher-Smith laboratories, LLC MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0245-0213_4b403bac-d62f-4886-b768-8e824d885187 0245-0213 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20041103 ANDA ANDA076725 Upsher-Smith laboratories, LLC MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0245-0271_24672ff6-88f0-4cb5-95c0-12d9907534f5 0245-0271 HUMAN PRESCRIPTION DRUG Oxandrolone Oxandrolone TABLET ORAL 20061201 ANDA ANDA076761 Upsher-Smith Laboratories, LLC OXANDROLONE 2.5 mg/1 CIII N 20181231 0245-0272_b8b1c14a-1d42-41e4-9468-d3a33f7e3cef 0245-0272 HUMAN PRESCRIPTION DRUG oxandrolone oxandrolone TABLET ORAL 20070322 ANDA ANDA078033 Upsher-Smith Laboratories, LLC OXANDROLONE 10 mg/1 CIII N 20181231 0245-0360_08fce906-5d33-41a2-aabd-e4bd7292ad38 0245-0360 HUMAN PRESCRIPTION DRUG KLOR-CON potassium chloride POWDER, FOR SOLUTION ORAL 20171023 ANDA ANDA209662 Upsher-Smith Laboratories, LLC POTASSIUM CHLORIDE 1.5 g/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0245-0410_93921eb6-6f98-41eb-88e5-066576e33b70 0245-0410 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170327 ANDA ANDA206484 Upsher-Smith Laboratories, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0245-0411_93921eb6-6f98-41eb-88e5-066576e33b70 0245-0411 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170327 ANDA ANDA206484 Upsher-Smith Laboratories, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0245-0412_93921eb6-6f98-41eb-88e5-066576e33b70 0245-0412 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170327 ANDA ANDA206484 Upsher-Smith Laboratories, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0245-0536_8bd7d029-32bc-43fe-b1e1-9c8e28ae880d 0245-0536 HUMAN PRESCRIPTION DRUG Cholestyramine Cholestyramine POWDER, FOR SUSPENSION ORAL 20120105 ANDA ANDA074557 Upsher-Smith Laboratories, Inc. CHOLESTYRAMINE 4 g/9g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] E 20171231 0245-0860_9c11bed2-811a-4ed8-89cc-8e56a0a9cee5 0245-0860 HUMAN PRESCRIPTION DRUG Vandazole Metronidazole GEL VAGINAL 20051004 NDA NDA021806 Upsher-Smith Laboratories, LLC METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0245-0871_64c6f76c-883b-4a94-b77b-90aa0e017783 0245-0871 HUMAN PRESCRIPTION DRUG Vogelxo Testosterone GEL TOPICAL 20140609 NDA NDA204399 Upsher-Smith Laboratories, LLC TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0245-0872_64c6f76c-883b-4a94-b77b-90aa0e017783 0245-0872 HUMAN PRESCRIPTION DRUG Vogelxo Testosterone GEL, METERED TOPICAL 20140609 NDA NDA204399 Upsher-Smith Laboratories, LLC TESTOSTERONE 12.5 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0245-1071_df51125d-d37c-4a00-acb8-5871a406216b 0245-1071 HUMAN PRESCRIPTION DRUG QUDEXY XR Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140411 NDA NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0245-1072_df51125d-d37c-4a00-acb8-5871a406216b 0245-1072 HUMAN PRESCRIPTION DRUG QUDEXY XR Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140411 NDA NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0245-1073_df51125d-d37c-4a00-acb8-5871a406216b 0245-1073 HUMAN PRESCRIPTION DRUG QUDEXY XR Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140411 NDA NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0245-1074_df51125d-d37c-4a00-acb8-5871a406216b 0245-1074 HUMAN PRESCRIPTION DRUG QUDEXY XR Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140411 NDA NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0245-1075_df51125d-d37c-4a00-acb8-5871a406216b 0245-1075 HUMAN PRESCRIPTION DRUG QUDEXY XR Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140411 NDA NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 150 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0254-3010_9b349968-03b7-4a4f-ab40-976570f5e398 0254-3010 HUMAN PRESCRIPTION DRUG Omega-3-acid ethyl esters Omega-3-acid ethyl esters CAPSULE ORAL 20170919 ANDA ANDA203893 Par Pharmaceutical Inc. OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 0256-0210_a79acae4-af7a-4054-9440-c6433ac9acb1 0256-0210 HUMAN OTC DRUG ThyroShield Potassium Iodide SOLUTION ORAL 20050401 ANDA ANDA077218 Fleming & Company, Pharmaceuticals POTASSIUM IODIDE 65 mg/mL E 20171231 0259-0501_d38431e5-062b-4757-ba54-29cb4b667a79 0259-0501 HUMAN PRESCRIPTION DRUG Cuvposa glycopyrrolate LIQUID ORAL 20130101 NDA NDA022571 Merz Pharmaceuticals, LLC GLYCOPYRROLATE 1 mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0259-1101_55b52ed2-b80f-44fa-92b8-1ebb7be2003f 0259-1101 HUMAN OTC DRUG Mederma for Kids Allantoin GEL TOPICAL 20140501 OTC MONOGRAPH FINAL part347 Merz Pharmaceuticals, LLC ALLANTOIN 10 mg/g E 20171231 0259-1102_39f10320-5a0e-4402-9f0e-8aa4ebf478fc 0259-1102 HUMAN PRESCRIPTION DRUG Naftin Naftifine Hydrochloride CREAM TOPICAL 20120301 NDA NDA019599 Merz Pharmaceuticals, LLC NAFTIFINE HYDROCHLORIDE 10 mg/2g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 0259-1105_a6dc7a71-aa33-49bc-b3c6-ed3e2b4aa022 0259-1105 HUMAN OTC DRUG Mederma Advanced Scar Allantoin GEL TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Merz Pharmaceuticals, LLC ALLANTOIN 5 mg/g E 20171231 0259-1139_9e08729f-3ade-4d2d-96ab-cb1f962885f7 0259-1139 HUMAN PRESCRIPTION DRUG Aluvea Urea CREAM TOPICAL 20110415 UNAPPROVED DRUG OTHER Merz Pharmaceuticals, LLC UREA 39 g/100g E 20171231 0259-1202_387726b6-3d9f-4f1e-bc56-06a806e5830f 0259-1202 HUMAN PRESCRIPTION DRUG Naftin Naftifine Hydrochloride GEL TOPICAL 20130901 NDA NDA204286 Merz Pharmaceuticals, LLC NAFTIFINE HYDROCHLORIDE 2 g/100g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 0259-1420_03eb05c6-af6e-453e-828e-247d91eb6185 0259-1420 HUMAN PRESCRIPTION DRUG Onmel ITRACONAZOLE TABLET ORAL 20121101 NDA NDA022484 Merz Pharmaceuticals, LLC ITRACONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0259-1605_27475dfe-82e1-47db-9872-09f82979d315 0259-1605 HUMAN PRESCRIPTION DRUG Xeomin incobotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20100901 BLA BLA125360 Merz Pharmaceuticals, LLC BOTULINUM TOXIN TYPE A 50 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 0259-1610_27475dfe-82e1-47db-9872-09f82979d315 0259-1610 HUMAN PRESCRIPTION DRUG Xeomin incobotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20100901 BLA BLA125360 Merz Pharmaceuticals, LLC BOTULINUM TOXIN TYPE A 100 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 0259-1620_27475dfe-82e1-47db-9872-09f82979d315 0259-1620 HUMAN PRESCRIPTION DRUG Xeomin incobotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20151120 BLA BLA125360 Merz Pharmaceuticals, LLC BOTULINUM TOXIN TYPE A 200 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 0259-2102_1917ad28-1f38-491f-840f-37a9525b6272 0259-2102 HUMAN OTC DRUG Mederma Stretch Marks Therapy dimethicone CREAM TOPICAL 20131201 OTC MONOGRAPH FINAL part347 Merz Pharmaceuticals, LLC DIMETHICONE 20 mg/g E 20171231 0259-2202_864a9aa7-6bbe-4f80-99e5-a65a70528860 0259-2202 HUMAN OTC DRUG Mederma PM Dimethicone CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Merz Pharmaceuticals, LLC DIMETHICONE 20 mg/g E 20171231 0259-3192_e77a42b4-815e-4c20-a4bd-1f88c6539813 0259-3192 HUMAN OTC DRUG Mederma AVOBENZONE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20071201 OTC MONOGRAPH FINAL part352 Merz Pharmaceuticals, LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 30; 100; 60 mg/g; mg/g; mg/g E 20171231 0259-4110_27475dfe-82e1-47db-9872-09f82979d315 0259-4110 HUMAN PRESCRIPTION DRUG Xeomin incobotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20100901 BLA BLA125360 Merz Pharmaceuticals, LLC BOTULINUM TOXIN TYPE A 100 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 0259-4126_00829a7d-d654-41d1-a4cd-fd61dd93c1fb 0259-4126 HUMAN PRESCRIPTION DRUG Naftin NAFTIFINE HYDROCHLORIDE CREAM TOPICAL 19980601 NDA NDA019599 Merz Pharmaceuticals, LLC NAFTIFINE HYDROCHLORIDE 10 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 0259-4150_27475dfe-82e1-47db-9872-09f82979d315 0259-4150 HUMAN PRESCRIPTION DRUG Xeomin incobotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20100901 BLA BLA125360 Merz Pharmaceuticals, LLC BOTULINUM TOXIN TYPE A 50 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 0259-4770_f62fc834-0f0b-4dd2-a2d9-a49274e51e34 0259-4770 HUMAN PRESCRIPTION DRUG Naftin NAFTIFINE HYDROCHLORIDE GEL TOPICAL 19901001 NDA NDA019356 Merz Pharmaceuticals, LLC NAFTIFINE HYDROCHLORIDE 10 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 0264-1290_2e0e3715-ffd6-4f3c-b61d-f6f27b1d43ea 0264-1290 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE INJECTION, SOLUTION INTRAVENOUS 20120313 UNAPPROVED DRUG OTHER B. Braun Medical Inc. DEXTROSE MONOHYDRATE 70 g/100mL N 20181231 0264-1510_e2335516-28c6-449a-871d-747350f5edf9 0264-1510 HUMAN PRESCRIPTION DRUG Dextrose Dextrose INJECTION, SOLUTION INTRAVENOUS 19731221 NDA NDA016730 B. Braun Medical Inc. DEXTROSE MONOHYDRATE 50 mg/mL N 20181231 0264-1800_4bf22bed-d1d8-41e1-a62a-fba940fd34a8 0264-1800 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19780208 NDA NDA017464 B. Braun Medical Inc. SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-1909_1ce47977-a86a-4359-8277-1c6bd81eb0d9 0264-1909 HUMAN PRESCRIPTION DRUG NephrAmine HISTIDINE, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE, and SODIUM BISULFITE INJECTION, SOLUTION INTRAVENOUS 19780224 NDA NDA017766 B. Braun Medical Inc. HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; CYSTEINE HYDROCHLORIDE .25; .56; .88; .64; .88; .88; .4; .2; .64; .014 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 0264-1915_56a22b79-5d8d-4ac8-a347-f62c09984001 0264-1915 HUMAN PRESCRIPTION DRUG ProcalAmine GLYCERIN, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, GLYCINE, ARGININE, HISTIDINE, PROLINE, SERINE, CYSTEINE, SODIUM ACETATE, MAGNESIUM ACETATE, CALCIUM ACETATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, PHOSPHORIC ACID, and POTASSIUM METABISULFITE INJECTION INTRAVENOUS 19820506 NDA NDA018582 B. Braun Medical Inc. GLYCERIN; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; GLYCINE; ARGININE; HISTIDINE; PROLINE; SERINE; CYSTEINE HYDROCHLORIDE; SODIUM ACETATE; MAGNESIUM ACETATE; CALCIUM ACETATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE; PHOSPHORIC ACID 3; .21; .27; .22; .16; .17; .12; .046; .2; .21; .42; .29; .085; .34; .18; .014; .2; .054; .026; .12; .15; .041 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-1940_468dc02f-1933-499f-a1f5-93eff27e4d6b 0264-1940 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE PARENTERAL 19780321 ANDA ANDA085870 B. Braun Medical Inc. POTASSIUM CHLORIDE 14.9 g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-1943_799c5123-e3fb-4311-94db-274870603a52 0264-1943 HUMAN PRESCRIPTION DRUG Hyperlyte CR Multi Electrolyte Concentrate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20120412 UNAPPROVED DRUG OTHER B. Braun Medical Inc. POTASSIUM ACETATE; SODIUM CHLORIDE; SODIUM ACETATE; MAGNESIUM CHLORIDE; CALCIUM CHLORIDE 1.96; 1.17; .68; .51; .37 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-1965_5181c451-ce09-45e1-bb89-7190866c65d4 0264-1965 HUMAN PRESCRIPTION DRUG HESPAN Hetastarch in Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19910404 NDA BN890105 B. Braun Medical Inc. HETASTARCH; SODIUM CHLORIDE 6; .9 g/100mL; g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-1968_79f3c629-3cc6-4ee7-82e8-6ca0d5ba1f4c 0264-1968 HUMAN PRESCRIPTION DRUG Hydroxyethyl Starch in Sodium Chloride Hydroxyethyl Starch in Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20150109 ANDA ANDA110013 B. Braun Medical Inc. HYDROXYETHYL STARCH 130/0.4; SODIUM CHLORIDE 6; 900 g/100mL; mg/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-2101_bcf719f0-b005-4f01-b264-43ad3669b9a9 0264-2101 HUMAN PRESCRIPTION DRUG Sterile Water Water IRRIGANT IRRIGATION 19700910 NDA NDA016734 B. Braun Medical Inc. WATER 1 mL/mL N 20181231 0264-2201_6f7aa749-d391-4f57-85b2-45d889efc157 0264-2201 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride IRRIGANT IRRIGATION 20090914 NDA NDA016733 B. Braun Medical Inc. SODIUM CHLORIDE .9 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-2202_ecf6a0b6-b959-401c-99a4-93bc9fe8e546 0264-2202 HUMAN PRESCRIPTION DRUG Ringers Sodium Chloride, Potassium Chloride, and Calcium Chloride IRRIGANT IRRIGATION 19790806 NDA NDA018156 B. Braun Medical Inc. SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE .86; .03; .033 g/100mL; g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0264-2203_7c56c5b1-0a48-43b6-b39c-954e9735d333 0264-2203 HUMAN PRESCRIPTION DRUG Lactated Ringers Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride IRRIGANT IRRIGATION 19821227 NDA NDA018681 B. Braun Medical Inc. SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE .6; .31; .03; .02 g/100mL; g/100mL; g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0264-2205_c1196345-862a-4c45-a505-7d73254b8fe7 0264-2205 HUMAN PRESCRIPTION DRUG Physiolyte Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride IRRIGANT IRRIGATION 19840608 NDA NDA019024 B. Braun Medical Inc. SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE .53; .5; .37; .037; .03 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0264-2301_9b645c76-5937-4845-81c3-a3e2e5948eba 0264-2301 HUMAN PRESCRIPTION DRUG Sorbitol Sorbitol IRRIGANT IRRIGATION 19780216 NDA NDA016741 B. Braun Medical Inc. SORBITOL 3.3 g/100mL E 20171231 0264-2302_b1e62532-7654-460a-81fe-5110366ff7c8 0264-2302 HUMAN PRESCRIPTION DRUG Glycine Glycine IRRIGANT IRRIGATION 19780206 NDA NDA016784 B. Braun Medical Inc. GLYCINE 1.5 g/100mL N 20181231 0264-2303_a6df35d3-121c-42e9-ae15-5ca17bd286a2 0264-2303 HUMAN PRESCRIPTION DRUG Mannitol Mannitol IRRIGANT IRRIGATION 19780210 NDA NDA016772 B. Braun Medical Inc. MANNITOL 5 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] N 20181231 0264-2304_e5500abd-7ea0-4bd2-bb43-bfe581ca7474 0264-2304 HUMAN PRESCRIPTION DRUG Acetic Acid Acetic Acid IRRIGANT IRRIGATION 19790806 NDA NDA018161 B. Braun Medical Inc. ACETIC ACID .25 g/100mL N 20181231 0264-2514_f0f620d0-55f9-41b8-a52e-40278165f128 0264-2514 HUMAN PRESCRIPTION DRUG Balanced Salt Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate SOLUTION IRRIGATION 20100203 ANDA ANDA091387 B. Braun Medical Inc. SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE 6.4; .75; .48; .3; 3.9; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 0264-3103_d341a6db-328c-4018-a08f-8bc985d5a7a5 0264-3103 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium SOLUTION INTRAVENOUS 20000727 NDA NDA050779 B. Braun Medical Inc. CEFAZOLIN SODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0264-3105_d341a6db-328c-4018-a08f-8bc985d5a7a5 0264-3105 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium SOLUTION INTRAVENOUS 20120113 NDA NDA050779 B. Braun Medical Inc. CEFAZOLIN SODIUM 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0264-3123_e2a528c2-4699-451d-98f8-3129aa946780 0264-3123 HUMAN PRESCRIPTION DRUG Cefoxitin and Dextrose CEFOXITIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20060310 NDA NDA065214 B. Braun Medical Inc. CEFOXITIN SODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0264-3125_e2a528c2-4699-451d-98f8-3129aa946780 0264-3125 HUMAN PRESCRIPTION DRUG Cefoxitin and Dextrose CEFOXITIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20060310 NDA NDA065214 B. Braun Medical Inc. CEFOXITIN SODIUM 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0264-3143_f54834fc-42a7-4894-9ce8-97560a10be03 0264-3143 HUMAN PRESCRIPTION DRUG Ceftazidime and Dextrose CEFTAZIDIME INJECTION, SOLUTION INTRAVENOUS 20110613 NDA NDA050823 B. Braun Medical Inc. CEFTAZIDIME 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0264-3145_f54834fc-42a7-4894-9ce8-97560a10be03 0264-3145 HUMAN PRESCRIPTION DRUG Ceftazidime and Dextrose CEFTAZIDIME INJECTION, SOLUTION INTRAVENOUS 20110613 NDA NDA050823 B. Braun Medical Inc. CEFTAZIDIME 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0264-3153_ef331852-55c0-4096-8a67-f1682f05df4f 0264-3153 HUMAN PRESCRIPTION DRUG CEFTRIAXONE AND DEXTROSE CEFTRIAXONE INJECTION, SOLUTION INTRAVENOUS 20050420 NDA NDA050796 B. Braun Medical Inc. CEFTRIAXONE SODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0264-3155_ef331852-55c0-4096-8a67-f1682f05df4f 0264-3155 HUMAN PRESCRIPTION DRUG CEFTRIAXONE AND DEXTROSE CEFTRIAXONE INJECTION, SOLUTION INTRAVENOUS 20050420 NDA NDA050796 B. Braun Medical Inc. CEFTRIAXONE SODIUM 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0264-3173_367e39ed-cb4c-443e-87e2-3f8ea50213c7 0264-3173 HUMAN PRESCRIPTION DRUG Cefotetan and Dextrose CEFOTETAN and DEXTROSE INJECTION, SOLUTION INTRAVENOUS 20100820 NDA NDA065430 B. Braun Medical Inc. CEFOTETAN DISODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0264-3175_367e39ed-cb4c-443e-87e2-3f8ea50213c7 0264-3175 HUMAN PRESCRIPTION DRUG Cefotetan and Dextrose CEFOTETAN and DEXTROSE INJECTION, SOLUTION INTRAVENOUS 20100820 NDA NDA065430 B. Braun Medical Inc. CEFOTETAN DISODIUM 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0264-3183_82b9673b-b9b3-41c2-98d3-0239c97d13c3 0264-3183 HUMAN PRESCRIPTION DRUG Meropenem and Sodium Chloride Meropenem and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20150430 NDA NDA202106 B. Braun Medical Inc. MEROPENEM; SODIUM CHLORIDE 500; .9 mg/50mL; g/50mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 0264-3185_82b9673b-b9b3-41c2-98d3-0239c97d13c3 0264-3185 HUMAN PRESCRIPTION DRUG Meropenem and Sodium Chloride Meropenem and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20150430 NDA NDA202106 B. Braun Medical Inc. MEROPENEM; SODIUM CHLORIDE 1; .9 g/50mL; g/50mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 0264-3193_f6ac0afe-8551-41b6-9c61-84d69094ef07 0264-3193 HUMAN PRESCRIPTION DRUG CEFEPIME HYDROCHLORIDE AND DEXTROSE CEFEPIME HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20100506 NDA NDA050821 B. Braun Medical Inc. CEFEPIME HYDROCHLORIDE 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0264-3195_f6ac0afe-8551-41b6-9c61-84d69094ef07 0264-3195 HUMAN PRESCRIPTION DRUG CEFEPIME HYDROCHLORIDE AND DEXTROSE CEFEPIME HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20100506 NDA NDA050821 B. Braun Medical Inc. CEFEPIME HYDROCHLORIDE 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0264-3200_cb9a87fe-ce94-4c61-9df1-4656cceacbf1 0264-3200 HUMAN PRESCRIPTION DRUG Plenamine LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE SOLUTION INTRAVENOUS 20150130 ANDA ANDA091112 B. Braun Medical Inc. LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; HISTIDINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE 1.18; 1.04; 1.04; 960; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 894; 749; 592; 434; 39 g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0264-3205_cb9a87fe-ce94-4c61-9df1-4656cceacbf1 0264-3205 HUMAN PRESCRIPTION DRUG Plenamine LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE SOLUTION INTRAVENOUS 20150130 ANDA ANDA091112 B. Braun Medical Inc. LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; HISTIDINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE 1.18; 1.04; 1.04; 960; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 894; 749; 592; 434; 39 g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0264-4460_98ac3792-f408-4726-a598-65579e51b05f 0264-4460 HUMAN PRESCRIPTION DRUG NutriLipid I.V. Fat Emulsion Soybean Oil INJECTION, SOLUTION INTRAVENOUS 20140630 NDA NDA019531 B. Braun Medical Inc. SOYBEAN OIL 20 g/100mL Lipid Emulsion [EPC],Lipids [Chemical/Ingredient] N 20181231 0264-5535_3e78170f-281a-4084-a4e5-f1ea36476186 0264-5535 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE SOLUTION INTRAVENOUS 19830929 NDA NDA018900 B. Braun Medical Inc. METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0264-7385_ba17af6b-3260-4448-bdfc-ab473cd80982 0264-7385 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION INTRAVENOUS 20140904 NDA NDA019633 B. Braun Medical Inc. WATER 1 mL/mL N 20181231 0264-7386_0c66d10e-3dd5-44a5-9b81-e1a241c03125 0264-7386 HUMAN PRESCRIPTION DRUG Sterile Water Sterile Water IRRIGANT IRRIGATION 20130913 NDA NDA016734 B. Braun Medical Inc. WATER 100 mL/100mL N 20181231 0264-7387_f8399a35-8b48-4993-a4dd-285ecf217660 0264-7387 HUMAN PRESCRIPTION DRUG Dextrose Dextrose SOLUTION INTRAVENOUS 20150219 NDA NDA019626 B. Braun Medical Inc. DEXTROSE 70 g/100mL N 20181231 0264-7388_484dc14f-81c6-484e-affb-2f30c35851e8 0264-7388 HUMAN PRESCRIPTION DRUG Sodium Chloride for Irrigation Sodium Chloride for Irrigation SOLUTION IRRIGATION 20130419 NDA NDA016733 B. Braun Medical Inc. SODIUM CHLORIDE .9 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7389_66d2e08f-48a7-4eea-a9dc-c58dd0a46fd3 0264-7389 HUMAN PRESCRIPTION DRUG Lactated Ringers Irrigation sodium chloride, sodium lactate, potassium chloride and calcium chloride SOLUTION IRRIGATION 20140902 NDA NDA018681 B. Braun Medical Inc. SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE 600; 310; 30; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0264-7390_d38469b0-8280-4c42-8c67-dc5ff66adc93 0264-7390 HUMAN PRESCRIPTION DRUG Glycine Glycine IRRIGANT IRRIGATION 20131204 NDA NDA016784 B. Braun Medical Inc. GLYCINE 1.5 g/100mL N 20181231 0264-7510_a499e920-4b0c-4aa2-9857-9e5bdb77b324 0264-7510 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE SOLUTION INTRAVENOUS 19880202 NDA NDA019626 B. Braun Medical Inc. DEXTROSE 5 g/100mL N 20181231 0264-7520_a499e920-4b0c-4aa2-9857-9e5bdb77b324 0264-7520 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE SOLUTION INTRAVENOUS 19880202 NDA NDA019626 B. Braun Medical Inc. DEXTROSE 10 g/100mL N 20181231 0264-7578_4e259082-1a2c-43c9-a4ab-85a27b7a468e 0264-7578 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 19930726 NDA NDA020006 B. Braun Medical Inc. MANNITOL 20 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] N 20181231 0264-7605_d10f3fde-8dae-4bc7-8ad8-196def3fb1c4 0264-7605 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 2.5; .45 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7608_d10f3fde-8dae-4bc7-8ad8-196def3fb1c4 0264-7608 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 3.3; .3 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7610_d10f3fde-8dae-4bc7-8ad8-196def3fb1c4 0264-7610 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 5; .9 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7612_d10f3fde-8dae-4bc7-8ad8-196def3fb1c4 0264-7612 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 5; .45 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7614_d10f3fde-8dae-4bc7-8ad8-196def3fb1c4 0264-7614 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 5; .33 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7616_d10f3fde-8dae-4bc7-8ad8-196def3fb1c4 0264-7616 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 5; .2 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7622_d10f3fde-8dae-4bc7-8ad8-196def3fb1c4 0264-7622 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 10; .45 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7623_d10f3fde-8dae-4bc7-8ad8-196def3fb1c4 0264-7623 HUMAN PRESCRIPTION DRUG Dextrose And Sodium Chloride DEXTROSE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 10; .2 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7625_b68780eb-a7bd-4ef0-ac64-85bffddbee74 0264-7625 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE IN DEXTROSE DEXTROSE and POTASSIUM CHLORIDE SOLUTION INTRAVENOUS 19890929 NDA NDA019699 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE 5; .15 g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7628_b68780eb-a7bd-4ef0-ac64-85bffddbee74 0264-7628 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE IN DEXTROSE DEXTROSE and POTASSIUM CHLORIDE SOLUTION INTRAVENOUS 19890929 NDA NDA019699 B. Braun Medical Inc. DEXTROSE; POTASSIUM CHLORIDE 5; .3 g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7703_4db4ff14-5d44-4e9b-a138-df6ef113ab28 0264-7703 HUMAN PRESCRIPTION DRUG Isolyte S SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19890929 NDA NDA019711 B. Braun Medical Inc. SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE .53; .5; .37; .037; .03 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0264-7704_cb81fe4a-10a7-4e24-aa4f-b4315fcfe39b 0264-7704 HUMAN PRESCRIPTION DRUG Isolyte S in Dextrose Hydrous Dextrose, Sodium Chloride, Sodium Gluconate, Sodium Acetate Trihydrate, Potassium Chloride and Magnesium Chloride Hexahydrate INJECTION, SOLUTION INTRAVENOUS 19930809 ANDA ANDA019843 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE 5; .53; .5; .37; .037; .03 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 0264-7707_5b859583-d20b-423d-97e2-c340d7a56bb8 0264-7707 HUMAN PRESCRIPTION DRUG Isolyte S pH 7.4 SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE INJECTION, SOLUTION INTRAVENOUS 19890929 NDA NDA019696 B. Braun Medical Inc. SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC .53; .5; .37; .037; .03; .012; .00082 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7730_451ceb0a-c083-4f3d-9c6e-87f10513211c 0264-7730 HUMAN PRESCRIPTION DRUG Isolyte P in Dextrose Dextrose, Sodium Acetate, Potassium Chloride, Magnesium Chloride, and Potassium Phosphate, Dibasic INJECTION, SOLUTION INTRAVENOUS 19930610 NDA NDA019873 B. Braun Medical Inc. DEXTROSE MONOHYDRATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC 5; .32; .13; .031; .026 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7750_041d5143-3e5a-4e1b-85b9-78d3d9cb264e 0264-7750 HUMAN PRESCRIPTION DRUG Lactated Ringers Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride INJECTION, SOLUTION INTRAVENOUS 19880229 NDA NDA019632 B. Braun Medical Inc. SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE .6; .31; .03; .02 g/100mL; g/100mL; g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0264-7750_4c03d095-40cf-4cb6-803d-dee934233dad 0264-7750 HUMAN PRESCRIPTION DRUG Lactated Ringers Sodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium Chloride INJECTION, SOLUTION INTRAVENOUS 19880229 NDA NDA019632 B. Braun Medical Inc. SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE .6; .31; .03; .02 g/100mL; g/100mL; g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0264-7751_1b96c8f6-84d1-4cd0-bebb-2a625f31f4f8 0264-7751 HUMAN PRESCRIPTION DRUG Dextrose in Lactated Ringers DEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880224 NDA NDA019634 B. Braun Medical Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE 5; .6; .31; .03; .02 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0264-7780_0f69cf9b-7180-41b1-b7ab-08b5a3d51200 0264-7780 HUMAN PRESCRIPTION DRUG Ringers Sodium Chloride, Calcium Chloride, and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19920417 NDA NDA020002 B. Braun Medical Inc. SODIUM CHLORIDE; CALCIUM CHLORIDE; POTASSIUM CHLORIDE .86; .033; .03 g/100mL; g/100mL; g/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0264-7800_268e98b7-98db-4c19-b023-37dca69dee16 0264-7800 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19880309 NDA NDA019635 B. Braun Medical Inc. SODIUM CHLORIDE .9 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0264-7800_8a6b1c02-0c75-4e1a-8066-41f4196bf03d 0264-7800 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880309 NDA NDA019635 B. Braun Medical Inc. SODIUM CHLORIDE .9 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0264-7800_bf805db6-9e30-4cfa-a638-ee9d88f20630 0264-7800 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20131231 NDA NDA019635 B. Braun Medical Inc. SODIUM CHLORIDE .9 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0264-7802_8a6b1c02-0c75-4e1a-8066-41f4196bf03d 0264-7802 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19880309 NDA NDA019635 B. Braun Medical Inc. SODIUM CHLORIDE .45 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7805_1069291f-7695-45da-a96c-02c51c9ab95f 0264-7805 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19880319 NDA NDA019635 B. Braun Medical Inc. SODIUM CHLORIDE 3 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7806_1069291f-7695-45da-a96c-02c51c9ab95f 0264-7806 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19880309 NDA NDA019635 B. Braun Medical Inc. SODIUM CHLORIDE 5 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-7850_20e9ac10-7362-4937-ab81-a1b4fec4105a 0264-7850 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION INTRAVENOUS 19880224 NDA NDA019633 B. Braun Medical Inc. WATER 1 mL/mL N 20181231 0264-7865_35869056-1007-414f-96b3-351b309b70a9 0264-7865 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE IN SODIUM CHLORIDE SODIUM CHLORIDE and POTASSIUM CHLORIDE SOLUTION INTRAVENOUS 19890929 NDA NDA019708 B. Braun Medical Inc. SODIUM CHLORIDE; POTASSIUM CHLORIDE .9; .15 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-8612_c04b2b6e-1162-4011-a351-a5b95af57643 0264-8612 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20140131 NDA NDA019631 B. Braun Medical Inc. DEXTROSE; SODIUM CHLORIDE 5; .45 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-9010_a7532439-29ef-433d-8505-c0a8bbfd549b 0264-9010 HUMAN PRESCRIPTION DRUG FreAmine III ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, CYSTEINE, PHOSPHORIC ACID, and SODIUM BISULFITE INJECTION, SOLUTION INTRAVENOUS 19710924 NDA NDA016822 B. Braun Medical Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; GLYCINE; CYSTEINE HYDROCHLORIDE; PHOSPHORIC ACID .69; .91; .73; .53; .56; .4; .15; .66; .71; .95; .28; 1.12; .59; 1.4; .016; .12 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0264-9341_e116b93b-0b11-405d-a179-8e6ddb133c9b 0264-9341 HUMAN PRESCRIPTION DRUG TrophAmine ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE SOLUTION INTRAVENOUS 19840720 NDA NDA019018 B. Braun Medical Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; CYSTEINE HYDROCHLORIDE; HISTIDINE; TYROSINE; N-ACETYLTYROSINE; ALANINE; ARGININE; PROLINE; SERINE; GLYCINE; ASPARTIC ACID; GLUTAMIC ACID; TAURINE .82; 1.4; 1.2; .34; .48; .42; .2; .78; .024; .48; .044; .24; .54; 1.2; .68; .38; .36; .32; .5; .025 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0264-9350_6ec6a7cd-2af3-4a8f-b727-755c02cd2f88 0264-9350 HUMAN PRESCRIPTION DRUG FreAmine HBC ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, CYSTEINE, and SODIUM BISULFITE INJECTION, SOLUTION INTRAVENOUS 19710924 NDA NDA016822 B. Braun Medical Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; GLYCINE; CYSTEINE HYDROCHLORIDE .76; 1.37; .41; .25; .32; .2; .09; .88; .4; .58; .16; .63; .33; .33; .014 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0264-9361_e116b93b-0b11-405d-a179-8e6ddb133c9b 0264-9361 HUMAN PRESCRIPTION DRUG TrophAmine ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE SOLUTION INTRAVENOUS 19840720 NDA NDA019018 B. Braun Medical Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; CYSTEINE HYDROCHLORIDE; HISTIDINE; TYROSINE; N-ACETYLTYROSINE; ALANINE; ARGININE; PROLINE; SERINE; GLYCINE; ASPARTIC ACID; GLUTAMIC ACID; TAURINE .49; .84; .69; .2; .29; .25; .12; .47; .02; .29; .044; .12; .32; .73; .41; .23; .22; .19; .3; .015 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0264-9371_aea1ea70-a8f9-4f7e-abe5-d8ac880c5df7 0264-9371 HUMAN PRESCRIPTION DRUG HepatAmine isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alani INJECTION, SOLUTION INTRAVENOUS 19820803 NDA NDA018676 B. Braun Medical Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; GLYCINE; CYSTEINE HYDROCHLORIDE; PHOSPHORIC ACID .9; 1.1; .61; .1; .1; .45; .066; .84; .77; .6; .24; .8; .5; .9; .014; .115 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0264-9375_1ce370d4-5f87-480b-8c35-c53c2311e870 0264-9375 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 20160809 NDA NDA019635 B. Braun Medical Inc. SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0264-9554_5df8f4d8-1afb-48e9-9175-768cf77c3064 0264-9554 HUMAN PRESCRIPTION DRUG Theophylline in Dextrose Theophylline Anhydrous and Dextrose INJECTION, SOLUTION INTRAVENOUS 19920814 NDA NDA019826 B. Braun Medical Inc. THEOPHYLLINE ANHYDROUS; DEXTROSE MONOHYDRATE 80; 5 mg/100mL; g/100mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0264-9567_82bf7254-281f-47ac-ab1f-9b45e20584ba 0264-9567 HUMAN PRESCRIPTION DRUG Heparin Sodium in Dextrose Heparin Sodium and Dextrose INJECTION INTRAVENOUS 19920720 NDA NDA019952 B. Braun Medical Inc. HEPARIN SODIUM; DEXTROSE MONOHYDRATE 4000; 5 [USP'U]/100mL; g/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0264-9577_82bf7254-281f-47ac-ab1f-9b45e20584ba 0264-9577 HUMAN PRESCRIPTION DRUG Heparin Sodium in Dextrose Heparin Sodium and Dextrose INJECTION INTRAVENOUS 19920720 NDA NDA019952 B. Braun Medical Inc. HEPARIN SODIUM; DEXTROSE MONOHYDRATE 5000; 5 [USP'U]/100mL; g/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0264-9587_82bf7254-281f-47ac-ab1f-9b45e20584ba 0264-9587 HUMAN PRESCRIPTION DRUG Heparin Sodium in Dextrose Heparin Sodium and Dextrose INJECTION INTRAVENOUS 19920720 NDA NDA019952 B. Braun Medical Inc. HEPARIN SODIUM; DEXTROSE MONOHYDRATE 10000; 5 [USP'U]/100mL; g/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0264-9594_a3798d10-d300-45ea-88d5-821f893aee96 0264-9594 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19920408 NDA NDA019830 B. Braun Medical Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS; DEXTROSE MONOHYDRATE .4; 5 g/100mL; g/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0264-9598_a3798d10-d300-45ea-88d5-821f893aee96 0264-9598 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19920408 NDA NDA019830 B. Braun Medical Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS; DEXTROSE MONOHYDRATE .8; 5 g/100mL; g/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0264-9872_6fc2ba36-6a78-4861-b19f-ed8c16efe29b 0264-9872 HUMAN PRESCRIPTION DRUG Heparin Sodium in Sodium Chloride Heparin Sodium in Sodium Chloride INJECTION INTRAVENOUS 19920720 NDA NDA019953 B. Braun Medical Inc. HEPARIN SODIUM 200 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0264-9999_0b437b15-62f3-46e3-b4e2-89fa95143c23 0264-9999 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 20171222 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE B. Braun Medical Inc. SODIUM CHLORIDE 900 mg/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0264-9999_5e0c9906-685c-4032-9a14-7a0c42480482 0264-9999 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 20140819 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE B. Braun Medical Inc. SODIUM CHLORIDE 450 mg/500mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0268-0021_0766bd18-1231-4513-91b7-e684882b764f 0268-0021 NON-STANDARDIZED ALLERGENIC CENTER-AL - ACACIA LONGIFOLIA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ACACIA LONGIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0024_0766bd18-1231-4513-91b7-e684882b764f 0268-0024 NON-STANDARDIZED ALLERGENIC CENTER-AL - ALNUS INCANA SSP. RUGOSA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0027_0766bd18-1231-4513-91b7-e684882b764f 0268-0027 NON-STANDARDIZED ALLERGENIC CENTER-AL - FRAXINUS AMERICANA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0030_0766bd18-1231-4513-91b7-e684882b764f 0268-0030 NON-STANDARDIZED ALLERGENIC CENTER-AL - PASPALUM NOTATUM POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0031_0766bd18-1231-4513-91b7-e684882b764f 0268-0031 NON-STANDARDIZED ALLERGENIC CENTER-AL - PASPALUM NOTATUM POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0034_0766bd18-1231-4513-91b7-e684882b764f 0268-0034 NON-STANDARDIZED ALLERGENIC CENTER-AL - FAGUS GRANDIFOLIA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0037_0766bd18-1231-4513-91b7-e684882b764f 0268-0037 NON-STANDARDIZED ALLERGENIC CENTER-AL - CYNODON DACTYLON POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CYNODON DACTYLON POLLEN 10000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0038_0766bd18-1231-4513-91b7-e684882b764f 0268-0038 NON-STANDARDIZED ALLERGENIC CENTER-AL - CYNODON DACTYLON POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CYNODON DACTYLON POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0041_0766bd18-1231-4513-91b7-e684882b764f 0268-0041 NON-STANDARDIZED ALLERGENIC CENTER-AL - BETULA LENTA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0044_0766bd18-1231-4513-91b7-e684882b764f 0268-0044 NON-STANDARDIZED ALLERGENIC CENTER-AL - POA ANNUA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. POA ANNUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0047_0766bd18-1231-4513-91b7-e684882b764f 0268-0047 NON-STANDARDIZED ALLERGENIC CENTER-AL - ACER NEGUNDO POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0050_0766bd18-1231-4513-91b7-e684882b764f 0268-0050 NON-STANDARDIZED ALLERGENIC CENTER-AL - BROMUS INERMIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0053_0766bd18-1231-4513-91b7-e684882b764f 0268-0053 NON-STANDARDIZED ALLERGENIC CENTER-AL - XANTHIUM STRUMARIUM POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0054_0766bd18-1231-4513-91b7-e684882b764f 0268-0054 NON-STANDARDIZED ALLERGENIC CENTER-AL - XANTHIUM STRUMARIUM POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM POLLEN 5000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0057_0766bd18-1231-4513-91b7-e684882b764f 0268-0057 NON-STANDARDIZED ALLERGENIC CENTER-AL - ZEA MAYS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ZEA MAYS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0060_43984319-a437-4743-b42f-54c8622e1bae 0268-0060 NON-STANDARDIZED ALLERGENIC CENTER-AL - POPULUS DELTOIDES SSP. MONILIFERA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0063_43984319-a437-4743-b42f-54c8622e1bae 0268-0063 NON-STANDARDIZED ALLERGENIC CENTER-AL - RUMEX ACETOSELLA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 0268-0066_43984319-a437-4743-b42f-54c8622e1bae 0268-0066 NON-STANDARDIZED ALLERGENIC CENTER-AL - RUMEX CRISPUS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. RUMEX CRISPUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0069_43984319-a437-4743-b42f-54c8622e1bae 0268-0069 NON-STANDARDIZED ALLERGENIC CENTER-AL - ULMUS AMERICANA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0072_43984319-a437-4743-b42f-54c8622e1bae 0268-0072 NON-STANDARDIZED ALLERGENIC CENTER-AL - ULMUS PUMILA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ULMUS PUMILA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0075_43984319-a437-4743-b42f-54c8622e1bae 0268-0075 NON-STANDARDIZED ALLERGENIC CENTER-AL - CORYLUS AMERICANA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0078_43984319-a437-4743-b42f-54c8622e1bae 0268-0078 NON-STANDARDIZED ALLERGENIC CENTER-AL - CARYA OVATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CARYA OVATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0087_43984319-a437-4743-b42f-54c8622e1bae 0268-0087 NON-STANDARDIZED ALLERGENIC CENTER-AL - SORGHUM HALEPENSE POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0090_43984319-a437-4743-b42f-54c8622e1bae 0268-0090 NON-STANDARDIZED ALLERGENIC CENTER-AL - POA PRATENSIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. POA PRATENSIS POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0091_43984319-a437-4743-b42f-54c8622e1bae 0268-0091 NON-STANDARDIZED ALLERGENIC CENTER-AL - POA PRATENSIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. POA PRATENSIS POLLEN 10000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0094_43984319-a437-4743-b42f-54c8622e1bae 0268-0094 NON-STANDARDIZED ALLERGENIC CENTER-AL - KOCHIA SCOPARIA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. BASSIA SCOPARIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0097_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0097 NON-STANDARDIZED ALLERGENIC CENTER-AL - CHENOPODIUM ALBUM POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0100_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0100 NON-STANDARDIZED ALLERGENIC CENTER-AL - ACER SACCHARUM POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0103_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0103 NON-STANDARDIZED ALLERGENIC CENTER-AL - FESTUCA PRATENSIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. FESTUCA PRATENSIS POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0104_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0104 NON-STANDARDIZED ALLERGENIC CENTER-AL - FESTUCA PRATENSIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. FESTUCA PRATENSIS POLLEN 10000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0107_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0107 NON-STANDARDIZED ALLERGENIC CENTER-AL - PROSOPIS JULIFLORA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PROSOPIS JULIFLORA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0110_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0110 NON-STANDARDIZED ALLERGENIC CENTER-AL - ARTEMISIA VULGARIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0113_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0113 NON-STANDARDIZED ALLERGENIC CENTER-AL - MORUS RUBRA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0116_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0116 NON-STANDARDIZED ALLERGENIC CENTER-AL - QUERCUS AGRIFOLIA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. QUERCUS AGRIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0119_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0119 NON-STANDARDIZED ALLERGENIC CENTER-AL - QUERCUS VIRGINIANA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. QUERCUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0122_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0122 NON-STANDARDIZED ALLERGENIC CENTER-AL - QUERCUS ALBA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0125_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0125 NON-STANDARDIZED ALLERGENIC CENTER-AL - AVENA SATIVA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AVENA SATIVA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0128_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0128 NON-STANDARDIZED ALLERGENIC CENTER-AL - OLEA EUROPAEA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0129_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0129 NON-STANDARDIZED ALLERGENIC CENTER-AL - OLEA EUROPAEA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0130_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0130 NON-STANDARDIZED ALLERGENIC CENTER-AL - OLEA EUROPAEA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN 10 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0131_a9256fd4-9901-47bc-896c-a10cdd7ce4c3 0268-0131 NON-STANDARDIZED ALLERGENIC CENTER-AL - OLEA EUROPAEA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN 100 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0134_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0134 NON-STANDARDIZED ALLERGENIC CENTER-AL - DACTYLIS GLOMERATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. DACTYLIS GLOMERATA POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0137_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0137 NON-STANDARDIZED ALLERGENIC CENTER-AL - CARYA ILLINOINENSIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0140_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0140 NON-STANDARDIZED ALLERGENIC CENTER-AL - AMARANTHUS RETROFLEXUS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0141_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0141 NON-STANDARDIZED ALLERGENIC CENTER-AL - AMARANTHUS RETROFLEXUS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN 5000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0144_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0144 NON-STANDARDIZED ALLERGENIC CENTER-AL - PLANTAGO LANCEOLATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0145_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0145 NON-STANDARDIZED ALLERGENIC CENTER-AL - PLANTAGO LANCEOLATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 100 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0146_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0146 NON-STANDARDIZED ALLERGENIC CENTER-AL - PLANTAGO LANCEOLATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0147_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0147 NON-STANDARDIZED ALLERGENIC CENTER-AL - PLANTAGO LANCEOLATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 10 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0150_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0150 NON-STANDARDIZED ALLERGENIC CENTER-AL - POPULUS ALBA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0153_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0153 NON-STANDARDIZED ALLERGENIC CENTER-AL - AMBROSIA ACANTHICARPA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ACANTHICARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0156_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0156 NON-STANDARDIZED ALLERGENIC CENTER-AL - AMBROSIA ARTEMISIIFOLIA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0157_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0157 NON-STANDARDIZED ALLERGENIC CENTER-AL - AMBROSIA ARTEMISIIFOLIA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 10000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0160_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0160 NON-STANDARDIZED ALLERGENIC CENTER-AL - AMBROSIA TRIFIDA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0161_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0161 NON-STANDARDIZED ALLERGENIC CENTER-AL - AMBROSIA TRIFIDA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0164_5c1a4f73-cd9d-408a-9de5-206efa183701 0268-0164 NON-STANDARDIZED ALLERGENIC CENTER-AL - AMBROSIA PSILOSTACHYA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA PSILOSTACHYA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0167_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0167 NON-STANDARDIZED ALLERGENIC CENTER-AL - AGROSTIS GIGANTEA Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AGROSTIS GIGANTEA TOP 20000 [PNU]/mL N 20181231 0268-0170_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0170 NON-STANDARDIZED ALLERGENIC CENTER-AL - SALSOLA KALI POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0173_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0173 NON-STANDARDIZED ALLERGENIC CENTER-AL - LOLIUM PERENNE POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. LOLIUM PERENNE POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0174_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0174 NON-STANDARDIZED ALLERGENIC CENTER-AL - LOLIUM PERENNE POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. LOLIUM PERENNE POLLEN 10000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0177_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0177 NON-STANDARDIZED ALLERGENIC CENTER-AL - ARTEMISIA TRIDENTATA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA TRIDENTATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0180_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0180 NON-STANDARDIZED ALLERGENIC CENTER-AL - ATRIPLEX WRIGHTII POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ATRIPLEX WRIGHTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0183_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0183 NON-STANDARDIZED ALLERGENIC CENTER-AL - ATRIPLEX WRIGHTII POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ATRIPLEX WRIGHTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0186_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0186 NON-STANDARDIZED ALLERGENIC CENTER-AL - PLATANUS OCCIDENTALIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0189_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0189 NON-STANDARDIZED ALLERGENIC CENTER-AL - PLATANUS RACEMOSA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PLATANUS RACEMOSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0192_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0192 NON-STANDARDIZED ALLERGENIC CENTER-AL - PHLEUM PRATENSE POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN 10000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0193_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0193 NON-STANDARDIZED ALLERGENIC CENTER-AL - PHLEUM PRATENSE POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0196_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0196 NON-STANDARDIZED ALLERGENIC CENTER-AL - HOLCUS LANATUS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. HOLCUS LANATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0199_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0199 NON-STANDARDIZED ALLERGENIC CENTER-AL - JUGLANS NIGRA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0202_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0202 NON-STANDARDIZED ALLERGENIC CENTER-AL - JUGLANS CALIFORNICA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. JUGLANS CALIFORNICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0205_2d1dc322-a48a-48b5-a953-5158a1f7a5b3 0268-0205 NON-STANDARDIZED ALLERGENIC CENTER-AL - SALIX NIGRA POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0247_6998440e-0c34-48bb-84a1-cf0903cade1c 0268-0247 HUMAN PRESCRIPTION DRUG Histamine Positive Skin Test Control histamine phosphate SOLUTION PERCUTANEOUS 19891023 BLA BLA103754 ALK-Abello, Inc. HISTAMINE PHOSPHATE 2.75 mg/mL N 20181231 0268-0248_6998440e-0c34-48bb-84a1-cf0903cade1c 0268-0248 HUMAN PRESCRIPTION DRUG histamine positive skin test control histamine phosphate INJECTION, SOLUTION INTRADERMAL 19891023 BLA BLA103754 ALK-Abello, Inc. HISTAMINE PHOSPHATE .275 mg/mL N 20181231 0268-0268_55746080-edfc-4d38-9d49-85a4329bbd2c 0268-0268 HUMAN PRESCRIPTION DRUG Cat Pelt, Standardized Cat Pelt, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19920924 BLA BLA103061 ALK-Abello, Inc. FELIS CATUS SKIN 10000 [BAU]/mL Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0269_55746080-edfc-4d38-9d49-85a4329bbd2c 0268-0269 HUMAN PRESCRIPTION DRUG Cat Pelt, Standardized Cat Pelt, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19920924 BLA BLA103061 ALK-Abello, Inc. FELIS CATUS SKIN 100 [BAU]/mL Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0274_55746080-edfc-4d38-9d49-85a4329bbd2c 0268-0274 HUMAN PRESCRIPTION DRUG Cat Pelt, Standardized Cat Pelt, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19920924 BLA BLA103061 ALK-Abello, Inc. FELIS CATUS SKIN 5000 [BAU]/mL Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0275_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-0275 HUMAN PRESCRIPTION DRUG Standardized Mite D. farinae Standardized Mite D. farinae INJECTION, SOLUTION SUBCUTANEOUS 19910708 BLA BLA103060 ALK-Abello, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0276_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-0276 HUMAN PRESCRIPTION DRUG Standardized Mite D. farinae Standardized Mite D. farinae INJECTION, SOLUTION SUBCUTANEOUS 19910708 BLA BLA103060 ALK-Abello, Inc. DERMATOPHAGOIDES FARINAE 5000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0277_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-0277 HUMAN PRESCRIPTION DRUG Standardized Mite D. pteronyssinus Standardized Mite D. pteronyssinus INJECTION, SOLUTION SUBCUTANEOUS 19900814 BLA BLA103752 ALK-Abello, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0278_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-0278 HUMAN PRESCRIPTION DRUG Standardized Mite D. pteronyssinus Standardized Mite D. pteronyssinus INJECTION, SOLUTION SUBCUTANEOUS 19900814 BLA BLA103752 ALK-Abello, Inc. DERMATOPHAGOIDES PTERONYSSINUS 5000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0279_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0279 HUMAN PRESCRIPTION DRUG Timothy, Standardized Timothy, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0280_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0280 HUMAN PRESCRIPTION DRUG Timothy, Standardized Timothy, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0281_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0281 HUMAN PRESCRIPTION DRUG Orchard Grass, Standardized Orchard Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103054 ALK-Abello, Inc. ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0282_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0282 HUMAN PRESCRIPTION DRUG Orchard Grass, Standardized Orchard Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103054 ALK-Abello, Inc. ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0283_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0283 HUMAN PRESCRIPTION DRUG Kentucky Bluegrass (June), Standardized Kentucky Bluegrass (June), Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103052 ALK-Abello, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0284_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0284 HUMAN PRESCRIPTION DRUG Kentucky Bluegrass (June), Standardized Kentucky Bluegrass (June), Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103052 ALK-Abello, Inc. POA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0285_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0285 HUMAN PRESCRIPTION DRUG Redtop Grass, Standardized Redtop Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103055 ALK-Abello, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0286_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0286 HUMAN PRESCRIPTION DRUG Redtop Grass, Standardized Redtop Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103055 ALK-Abello, Inc. AGROSTIS GIGANTEA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0287_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0287 HUMAN PRESCRIPTION DRUG Sweet Vernal Grass, Standardized Sweet Vernal Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103057 ALK-Abello, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0288_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0288 HUMAN PRESCRIPTION DRUG Sweet Vernal Grass, Standardized Sweet Vernal Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103057 ALK-Abello, Inc. ANTHOXANTHUM ODORATUM POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0289_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0289 HUMAN PRESCRIPTION DRUG Rye Grass, Perennial Standardized Rye Grass, Perennial Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103056 ALK-Abello, Inc. ALLERGENIC EXTRACT- RYEGRASS, PERENNIAL LOLIUM PERENNE 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0290_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0290 HUMAN PRESCRIPTION DRUG Rye Grass, Perennial Standardized Rye Grass, Perennial Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103056 ALK-Abello, Inc. ALLERGENIC EXTRACT- RYEGRASS, PERENNIAL LOLIUM PERENNE 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0291_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0291 HUMAN PRESCRIPTION DRUG Meadow Fescue Grass, Standardized Meadow Fescue Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103053 ALK-Abello, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0292_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0292 HUMAN PRESCRIPTION DRUG Meadow Fescue Grass, Standardized Meadow Fescue Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103053 ALK-Abello, Inc. FESTUCA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0293_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-0293 HUMAN PRESCRIPTION DRUG Bermuda Grass, Standardized Bermuda Grass, Standardized INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103051 ALK-Abello, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0603_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0603 NON-STANDARDIZED ALLERGENIC BOS TAURUS SKIN CATTLE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOS TAURUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0604_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0604 NON-STANDARDIZED ALLERGENIC BOS TAURUS SKIN CATTLE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOS TAURUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0605_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0605 NON-STANDARDIZED ALLERGENIC BOS TAURUS SKIN CATTLE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOS TAURUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0606_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0606 NON-STANDARDIZED ALLERGENIC BOS TAURUS SKIN CATTLE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOS TAURUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0609_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0609 NON-STANDARDIZED ALLERGENIC COTTON FIBER COTTON LINTERS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COTTON FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0612_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0612 NON-STANDARDIZED ALLERGENIC COTTON SEED COTTONSEED INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COTTON SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 0268-0615_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0615 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0616_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0616 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 1000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0617_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0617 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 10 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0618_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0618 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 100 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0619_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0619 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0620_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0620 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0621_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0621 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .05 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0622_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0622 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .005 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0623_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0623 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .0005 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0624_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0624 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .001 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0625_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0625 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .01 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0626_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0626 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0627_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0627 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0628_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0628 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0629_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0629 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0630_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0630 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0631_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0631 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0632_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0632 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN 100 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0635_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0635 NON-STANDARDIZED ALLERGENIC CEIBA PENTANDRA FIBER KAPOK INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CEIBA PENTANDRA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0638_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0638 NON-STANDARDIZED ALLERGENIC MUS MUSCULUS SKIN MOUSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUS MUSCULUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0639_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0639 NON-STANDARDIZED ALLERGENIC MUS MUSCULUS SKIN MOUSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUS MUSCULUS SKIN 100 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0642_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0642 NON-STANDARDIZED ALLERGENIC ORRIS IRIS X GERMANICA ROOT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IRIS X GERMANICA ROOT .05 g/mL N 20181231 0268-0645_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0645 NON-STANDARDIZED ALLERGENIC PYRETHRUM CINERARIIFOLIUM PYRETHRUM CINERARIIFOLIUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TANACETUM CINERARIIFOLIUM FLOWER .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-0646_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0646 NON-STANDARDIZED ALLERGENIC PYRETHRUM CINERARIIFOLIUM PYRETHRUM CINERARIIFOLIUM INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. TANACETUM CINERARIIFOLIUM FLOWER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-0649_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0649 NON-STANDARDIZED ALLERGENIC RABBIT RABBIT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RABBIT 10000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 0268-0650_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0650 NON-STANDARDIZED ALLERGENIC RABBIT RABBIT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RABBIT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 0268-0651_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0651 NON-STANDARDIZED ALLERGENIC RABBIT RABBIT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RABBIT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 0268-0652_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0652 NON-STANDARDIZED ALLERGENIC RABBIT RABBIT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RABBIT 20000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 0268-0653_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0653 NON-STANDARDIZED ALLERGENIC CAVIA PORCELLUS SKIN GUINEA PIG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CAVIA PORCELLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0654_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0654 NON-STANDARDIZED ALLERGENIC CAVIA PORCELLUS SKIN GUINEA PIG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CAVIA PORCELLUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0655_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0655 NON-STANDARDIZED ALLERGENIC CAVIA PORCELLUS SKIN GUINEA PIG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CAVIA PORCELLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0656_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0656 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0705_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0705 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0706_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0706 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0707_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0707 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0708_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0708 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA 1000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0709_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0709 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA 10 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0710_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0710 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA 100 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0711_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0711 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA AMERICAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA .001 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0714_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0714 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0715_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0715 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 1000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0716_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0716 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 10 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0717_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0717 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 100 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0718_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0718 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0719_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0719 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0720_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0720 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA .001 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0721_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0721 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA GERMAN COCKROACH INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 500 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0722_c12525ee-2e21-4ac1-ba59-2ac3bd7cc270 0268-0722 NON-STANDARDIZED ALLERGENIC FIRE ANT FIRE ANT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLENOPSIS INVICTA .05 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0723_c12525ee-2e21-4ac1-ba59-2ac3bd7cc270 0268-0723 NON-STANDARDIZED ALLERGENIC MIXED FEATHERS MIXED FEATHERS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .05; .005; .05 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] N 20181231 0268-0723_d9e9fa3c-d7f0-4b08-9b7d-ba10e025eaca 0268-0723 NON-STANDARDIZED ALLERGENIC MIXED FEATHERS GALLUS GALLUS FEATHER, ANAS PLATYRHYNCHOS FEATHER, ANSER ANSER FEATHER INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] N 20181231 0268-0724_356d3b28-7f35-4b8d-965e-dc8fc14856f3 0268-0724 NON-STANDARDIZED ALLERGENIC FIRE ANT SOLENOPSIS INVICTA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLENOPSIS INVICTA .1 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0725_356d3b28-7f35-4b8d-965e-dc8fc14856f3 0268-0725 NON-STANDARDIZED ALLERGENIC MOSQUITO CULEX PIPIENS INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CULEX PIPIENS .01 g/mL N 20181231 0268-0800_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0800 NON-STANDARDIZED ALLERGENIC ACREMONIUM STRICTUM SAROCLADIUM STRICTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SAROCLADIUM STRICTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0801_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0801 NON-STANDARDIZED ALLERGENIC ACREMONIUM STRICTUM SAROCLADIUM STRICTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SAROCLADIUM STRICTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0802_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0802 NON-STANDARDIZED ALLERGENIC ACREMONIUM STRICTUM SAROCLADIUM STRICTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SAROCLADIUM STRICTUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0803_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0803 NON-STANDARDIZED ALLERGENIC ACREMONIUM STRICTUM SAROCLADIUM STRICTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SAROCLADIUM STRICTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0805_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0805 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0806_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0806 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0807_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0807 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0808_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0808 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0809_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0809 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0810_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0810 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 10 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0811_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0811 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA .01 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0812_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0812 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0813_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0813 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA .02 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0814_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0814 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0815_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0815 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0816_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0816 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS ALTERNARIA TENUIS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0817_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0817 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0818_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0818 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0819_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0819 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0820_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0820 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0821_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0821 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 10 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0822_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0822 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0823_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0823 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS .02 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0824_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0824 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0825_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0825 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0826_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0826 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS ASPERGILLUS FUMIGATUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0827_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0827 NON-STANDARDIZED ALLERGENIC ASPERGILLUS NIGER VAR NIGER ASPERGILLUS NIGER INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0828_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0828 NON-STANDARDIZED ALLERGENIC ASPERGILLUS NIGER VAR NIGER ASPERGILLUS NIGER INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0829_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0829 NON-STANDARDIZED ALLERGENIC ASPERGILLUS NIGER VAR NIGER ASPERGILLUS NIGER INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0830_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0830 NON-STANDARDIZED ALLERGENIC ASPERGILLUS NIGER VAR NIGER ASPERGILLUS NIGER INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0832_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0832 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLULANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0833_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0833 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLULANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0834_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0834 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLULANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0835_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0835 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLULANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0836_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0836 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLULANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0837_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0837 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA BOTRYTIS CINEREA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0838_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0838 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA BOTRYTIS CINEREA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0839_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0839 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA BOTRYTIS CINEREA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0840_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0840 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA BOTRYTIS CINEREA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0841_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0841 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA BOTRYTIS CINEREA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0842_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0842 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS .01 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-0843_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0843 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 20000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-0844_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0844 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 10000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-0845_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0845 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 40000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-0846_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0846 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 1000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-0847_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0847 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 100 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-0848_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0848 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS .02 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-0849_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0849 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 20000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-0850_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0850 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS CANDIDA ALBICANS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 10000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-0851_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0851 NON-STANDARDIZED ALLERGENIC CHAETOMIUM GLOBOSUM CHAETOMIUM GLOBOSUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHAETOMIUM GLOBOSUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0852_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0852 NON-STANDARDIZED ALLERGENIC CHAETOMIUM GLOBOSUM CHAETOMIUM GLOBOSUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHAETOMIUM GLOBOSUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0853_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0853 NON-STANDARDIZED ALLERGENIC CHAETOMIUM GLOBOSUM CHAETOMIUM GLOBOSUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHAETOMIUM GLOBOSUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0855_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0855 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0856_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0856 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0857_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0857 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0858_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0858 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0859_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0859 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES .01 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0860_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0860 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0861_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0861 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES CLADOSPORIUM CLADOSPORIOIDES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0863_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0863 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0864_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0864 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0865_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0865 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0866_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0866 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0867_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0867 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 10 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0868_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0868 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0869_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0869 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0870_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0870 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0871_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0871 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0878_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0878 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0879_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0879 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0880_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0880 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0881_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0881 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0882_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0882 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0883_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0883 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0884_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0884 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 20000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 0268-0885_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0885 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 10000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 0268-0886_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0886 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 40000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 0268-0887_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0887 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 1000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 0268-0888_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0888 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 10 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 0268-0889_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0889 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 100 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 0268-0890_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0890 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM .025 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 0268-0891_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0891 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM .001 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 0268-0892_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0892 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 20000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 0268-0893_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0893 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM EPICOCCUM NIGRUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 10000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 0268-0894_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0894 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0895_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0895 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0896_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0896 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0897_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0897 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0898_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0898 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 10 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0899_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0899 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0900_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0900 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0901_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0901 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0902_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0902 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM VASINFECTUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0903_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0903 NON-STANDARDIZED ALLERGENIC HELMINTHOSPORIUM SOLANI HELMINTHOSPORIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HELMINTHOSPORIUM SOLANI 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0904_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0904 NON-STANDARDIZED ALLERGENIC HELMINTHOSPORIUM SOLANI HELMINTHOSPORIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HELMINTHOSPORIUM SOLANI 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0905_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0905 NON-STANDARDIZED ALLERGENIC HELMINTHOSPORIUM SOLANI HELMINTHOSPORIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HELMINTHOSPORIUM SOLANI 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0906_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0906 NON-STANDARDIZED ALLERGENIC HELMINTHOSPORIUM SOLANI HELMINTHOSPORIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HELMINTHOSPORIUM SOLANI 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0911_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0911 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS MUCOR PLUMBEUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0912_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0912 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS MUCOR PLUMBEUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0913_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0913 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS MUCOR PLUMBEUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0914_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0914 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS MUCOR PLUMBEUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0915_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0915 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS MUCOR PLUMBEUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0916_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0916 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA NEUROSPORA INTERMEDIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0917_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0917 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA NEUROSPORA INTERMEDIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0918_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0918 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA NEUROSPORA INTERMEDIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0919_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0919 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA NEUROSPORA INTERMEDIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0920_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0920 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA NEUROSPORA INTERMEDIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0921_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0921 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0922_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0922 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0923_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0923 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0924_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0924 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 100 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0925_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0925 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0926_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0926 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM PENICILLIUM CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0928_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0928 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0929_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0929 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0930_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0930 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0931_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0931 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0932_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0932 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0933_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0933 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA PHOMA HERBARUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0934_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0934 NON-STANDARDIZED ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS RHIZOPUS BATATAS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0935_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0935 NON-STANDARDIZED ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS RHIZOPUS BATATAS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0936_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0936 NON-STANDARDIZED ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS RHIZOPUS BATATAS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0937_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0937 NON-STANDARDIZED ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS RHIZOPUS BATATAS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0939_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0939 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0940_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0940 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0941_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0941 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0942_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0942 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0943_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0943 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0944_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0944 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA RHODOTORULA RUBRA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0945_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0945 NON-STANDARDIZED ALLERGENIC USTILAGO MAYDIS CORN SMUT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. USTILAGO MAYDIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0946_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0946 NON-STANDARDIZED ALLERGENIC USTILAGO MAYDIS CORN SMUT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. USTILAGO MAYDIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0952_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0952 NON-STANDARDIZED ALLERGENIC USTILAGO TRITICI LOOSE WHEAT SMUT INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. USTILAGO TRITICI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0955_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0955 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI STEMPHYLIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0956_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0956 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI STEMPHYLIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0957_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0957 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI STEMPHYLIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0958_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0958 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI STEMPHYLIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI .001 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0959_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0959 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI STEMPHYLIUM SOLANI INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0961_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0961 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0962_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0962 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0963_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0963 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0965_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0965 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES .005 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0966_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0966 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0967_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0967 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES TRICHOPHYTON MENTAGROPHYTES INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0968_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0968 NON-STANDARDIZED ALLERGENIC SACCHAROMYCES CEREVISIAE SACCHAROMYCES CEREVISIAE INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SACCHAROMYCES CEREVISIAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20181231 0268-0969_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-0969 NON-STANDARDIZED ALLERGENIC SACCHAROMYCES CEREVISIAE SACCHAROMYCES CEREVISIAE INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SACCHAROMYCES CEREVISIAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20181231 0268-0970_c12525ee-2e21-4ac1-ba59-2ac3bd7cc270 0268-0970 NON-STANDARDIZED ALLERGENIC MIXED ASPERGILLUS MIXED ASPERGILLUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS TERREUS 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-0971_356d3b28-7f35-4b8d-965e-dc8fc14856f3 0268-0971 NON-STANDARDIZED ALLERGENIC CURVULARIA CURVULARIA INAEQUALIS INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CURVULARIA INAEQUALIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1000_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1000 NON-STANDARDIZED ALLERGENIC ACACIA Acacia INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACACIA .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1001_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1001 NON-STANDARDIZED ALLERGENIC ACACIA Acacia INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACACIA .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1004_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1004 NON-STANDARDIZED ALLERGENIC AILANTHUS ALTISSIMA POLLEN Ailanthus Tree of Heaven INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1007_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1007 NON-STANDARDIZED ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN Alder White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1008_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1008 NON-STANDARDIZED ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN Alder White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1009_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1009 NON-STANDARDIZED ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN Alder White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1012_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1012 NON-STANDARDIZED ALLERGENIC MEDICAGO SATIVA POLLEN Alfalfa INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MEDICAGO SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1013_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1013 NON-STANDARDIZED ALLERGENIC MEDICAGO SATIVA POLLEN Alfalfa INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MEDICAGO SATIVA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1016_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1016 NON-STANDARDIZED ALLERGENIC FRAXINUS VELUTINA POLLEN Ash Arizona INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS VELUTINA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1017_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1017 NON-STANDARDIZED ALLERGENIC FRAXINUS VELUTINA POLLEN Ash Arizona INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1018_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1018 NON-STANDARDIZED ALLERGENIC FRAXINUS VELUTINA POLLEN Ash Arizona INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS VELUTINA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1021_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1021 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1022_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1022 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1023_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1023 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1024_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1024 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1025_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1025 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1026_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1026 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN Ash White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1029_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1029 NON-STANDARDIZED ALLERGENIC POPULUS TREMULOIDES POLLEN Aspen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS TREMULOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1030_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1030 NON-STANDARDIZED ALLERGENIC POPULUS TREMULOIDES POLLEN Aspen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS TREMULOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1033_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1033 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1034_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1034 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1035_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1035 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1036_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1036 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1037_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1037 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1038_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1038 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1041_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1041 NON-STANDARDIZED ALLERGENIC MORELLA CERIFERA POLLEN Bayberry Wax Myrtle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORELLA CERIFERA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1042_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1042 NON-STANDARDIZED ALLERGENIC MORELLA CERIFERA POLLEN Bayberry Wax Myrtle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORELLA CERIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1043_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1043 NON-STANDARDIZED ALLERGENIC MORELLA CERIFERA POLLEN Bayberry Wax Myrtle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORELLA CERIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1046_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1046 NON-STANDARDIZED ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1047_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1047 NON-STANDARDIZED ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1048_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1048 NON-STANDARDIZED ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1049_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1049 NON-STANDARDIZED ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1056_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1056 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1057_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1057 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1058_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1058 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1059_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1059 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN 50000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1062_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1062 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN Birch River Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1063_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1063 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN Birch River Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1064_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1064 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN Birch River Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1065_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1065 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN Birch River Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1066_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1066 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN Birch River Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1069_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1069 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1070_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1070 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1071_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1071 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1072_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1072 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .0005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1073_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1073 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Birch White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1076_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1076 NON-STANDARDIZED ALLERGENIC POA ANNUA POLLEN Bluegrass Annual INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POA ANNUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1077_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1077 NON-STANDARDIZED ALLERGENIC POA ANNUA POLLEN Bluegrass Annual INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1080_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1080 NON-STANDARDIZED ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1081_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1081 NON-STANDARDIZED ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1082_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1082 NON-STANDARDIZED ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1083_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1083 NON-STANDARDIZED ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1086_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1086 NON-STANDARDIZED ALLERGENIC BROMUS INERMIS POLLEN Brome Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1087_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1087 NON-STANDARDIZED ALLERGENIC BROMUS INERMIS POLLEN Brome Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1088_1a4a3c2d-f74a-47d1-bd6f-9037f5cfa016 0268-1088 NON-STANDARDIZED ALLERGENIC CENTER-AL - BROMUS INERMIS POLLEN Allergenic Extracts Alum Precipitated INJECTION, SUSPENSION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1089_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1089 NON-STANDARDIZED ALLERGENIC BROMUS INERMIS POLLEN Brome Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1092_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1092 NON-STANDARDIZED ALLERGENIC AMARANTHUS PALMERI POLLEN Carelessweed INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1093_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1093 NON-STANDARDIZED ALLERGENIC AMARANTHUS PALMERI POLLEN Carelessweed INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS PALMERI POLLEN .025 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1094_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1094 NON-STANDARDIZED ALLERGENIC AMARANTHUS PALMERI POLLEN Carelessweed INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS PALMERI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1097_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1097 NON-STANDARDIZED ALLERGENIC JUNIPERUS ASHEI POLLEN Cedar Mountain INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS ASHEI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1098_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1098 NON-STANDARDIZED ALLERGENIC JUNIPERUS ASHEI POLLEN Cedar Mountain INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1099_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1099 NON-STANDARDIZED ALLERGENIC JUNIPERUS ASHEI POLLEN Cedar Mountain INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS ASHEI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1102_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1102 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1103_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1103 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1104_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1104 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1105_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1105 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .0005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1106_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1106 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1107_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1107 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1110_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1110 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1111_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1111 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1112_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1112 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1113_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1113 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1114_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1114 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 10 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1115_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1115 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 100 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1116_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1116 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1117_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1117 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1120_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1120 NON-STANDARDIZED ALLERGENIC ZEA MAYS POLLEN Corn Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ZEA MAYS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1121_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1121 NON-STANDARDIZED ALLERGENIC ZEA MAYS POLLEN Corn Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1122_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1122 NON-STANDARDIZED ALLERGENIC ZEA MAYS POLLEN Corn Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ZEA MAYS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1123_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1123 NON-STANDARDIZED ALLERGENIC ZEA MAYS POLLEN Corn Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ZEA MAYS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1126_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1126 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1127_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1127 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1128_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1128 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1129_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1129 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1130_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1130 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1133_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1133 NON-STANDARDIZED ALLERGENIC POPULUS FREMONTII POLLEN Cottonwood Fremont INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS FREMONTII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1134_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1134 NON-STANDARDIZED ALLERGENIC POPULUS FREMONTII POLLEN Cottonwood Fremont INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS FREMONTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1135_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1135 NON-STANDARDIZED ALLERGENIC POPULUS FREMONTII POLLEN Cottonwood Fremont INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS FREMONTII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1138_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1138 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES SSP MONILIFERA POLLEN Cottonwood Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1139_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1139 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES SSP MONILIFERA POLLEN Cottonwood Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1142_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1142 NON-STANDARDIZED ALLERGENIC CUPRESSUS ARIZONICA POLLEN Cypress Arizona INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CUPRESSUS ARIZONICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1143_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1143 NON-STANDARDIZED ALLERGENIC CUPRESSUS ARIZONICA POLLEN Cypress Arizona INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1146_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1146 NON-STANDARDIZED ALLERGENIC TAXODIUM DISTICHUM POLLEN Cypress Bald INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TAXODIUM DISTICHUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1147_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1147 NON-STANDARDIZED ALLERGENIC TAXODIUM DISTICHUM POLLEN Cypress Bald INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TAXODIUM DISTICHUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1148_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1148 NON-STANDARDIZED ALLERGENIC TAXODIUM DISTICHUM POLLEN Cypress Bald INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TAXODIUM DISTICHUM POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1150_356d3b28-7f35-4b8d-965e-dc8fc14856f3 0268-1150 NON-STANDARDIZED ALLERGENIC MIXED COCKROACH PERIPLANETA AMERICANA and BLATTELLA GERMANICA INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA; BLATTELLA GERMANICA .05; .05 g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1150_bdbd5a26-7d68-4b38-b50d-19cb2d40e29a 0268-1150 NON-STANDARDIZED ALLERGENIC MIXED COCKROACH BLATELLA GERMANICA and PERIPLANETA AMERICANA INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA; BLATELLA GERMANICA .05; .05 g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1151_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1151 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 0268-1152_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1152 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 0268-1153_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1153 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 0268-1154_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1154 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 0268-1155_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1155 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 0268-1156_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1156 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 60000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 0268-1159_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1159 NON-STANDARDIZED ALLERGENIC RUMEX CRISPUS POLLEN Dock Yellow INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX CRISPUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1160_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1160 NON-STANDARDIZED ALLERGENIC RUMEX CRISPUS POLLEN Dock Yellow INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX CRISPUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1161_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1161 NON-STANDARDIZED ALLERGENIC RUMEX CRISPUS POLLEN Dock Yellow INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX CRISPUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1164_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1164 NON-STANDARDIZED ALLERGENIC EUPATORIUM CAPILLIFOLIUM POLLEN Dog Fennel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1165_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1165 NON-STANDARDIZED ALLERGENIC EUPATORIUM CAPILLIFOLIUM POLLEN Dog Fennel Non Stock INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1168_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1168 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1169_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1169 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1170_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1170 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1171_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1171 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN .005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1172_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1172 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN .0005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1173_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1173 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1174_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1174 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1177_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1177 NON-STANDARDIZED ALLERGENIC ULMUS CRASSIFOLIA POLLEN Elm Cedar INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS CRASSIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1178_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1178 NON-STANDARDIZED ALLERGENIC ULMUS CRASSIFOLIA POLLEN Elm Cedar INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS CRASSIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1181_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1181 NON-STANDARDIZED ALLERGENIC ULMUS PUMILA POLLEN Elm Chinese INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS PUMILA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1182_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1182 NON-STANDARDIZED ALLERGENIC ULMUS PUMILA POLLEN Elm Chinese INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS PUMILA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1185_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1185 NON-STANDARDIZED ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUCALYPTUS GLOBULUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1186_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1186 NON-STANDARDIZED ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1187_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1187 NON-STANDARDIZED ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUCALYPTUS GLOBULUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1188_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1188 NON-STANDARDIZED ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUCALYPTUS GLOBULUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1191_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1191 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1192_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1192 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1193_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1193 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1194_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1194 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1195_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1195 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1198_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1198 NON-STANDARDIZED ALLERGENIC CELTIS OCCIDENTALIS POLLEN Hackberry INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CELTIS OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1199_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1199 NON-STANDARDIZED ALLERGENIC CELTIS OCCIDENTALIS POLLEN Hackberry INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1200_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1200 NON-STANDARDIZED ALLERGENIC CELTIS OCCIDENTALIS POLLEN Hackberry INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CELTIS OCCIDENTALIS POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1203_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1203 NON-STANDARDIZED ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1204_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1204 NON-STANDARDIZED ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1205_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1205 NON-STANDARDIZED ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1206_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1206 NON-STANDARDIZED ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1214_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1214 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1215_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1215 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1216_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1216 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1217_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1217 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN .005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1218_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1218 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN .0005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1219_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1219 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1220_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1220 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1223_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1223 NON-STANDARDIZED ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Juniper Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS CALIFORNICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1224_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1224 NON-STANDARDIZED ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Juniper Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1225_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1225 NON-STANDARDIZED ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Juniper Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS CALIFORNICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1232_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1232 NON-STANDARDIZED ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BASSIA SCOPARIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1233_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1233 NON-STANDARDIZED ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BASSIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1234_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1234 NON-STANDARDIZED ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BASSIA SCOPARIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1235_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1235 NON-STANDARDIZED ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BASSIA SCOPARIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1238_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1238 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1239_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1239 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1240_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1240 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1241_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1241 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1242_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1242 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1245_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1245 NON-STANDARDIZED ALLERGENIC ROBINIA PSEUDOACACIA POLLEN Locust Black Non Stock INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ROBINIA PSEUDOACACIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1248_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1248 NON-STANDARDIZED ALLERGENIC ACER RUBRUM POLLEN Maple Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER RUBRUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1249_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1249 NON-STANDARDIZED ALLERGENIC ACER RUBRUM POLLEN Maple Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER RUBRUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1252_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1252 NON-STANDARDIZED ALLERGENIC ACER SACCHARUM POLLEN Maple Sugar INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1253_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1253 NON-STANDARDIZED ALLERGENIC ACER SACCHARUM POLLEN Maple Sugar INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1254_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1254 NON-STANDARDIZED ALLERGENIC ACER SACCHARUM POLLEN Maple Sugar INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1255_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1255 NON-STANDARDIZED ALLERGENIC ACER SACCHARUM POLLEN Maple Sugar INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1258_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1258 NON-STANDARDIZED ALLERGENIC IVA XANTHIFOLIA POLLEN Marshelder Burweed INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CYCLACHAENA XANTHIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1259_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1259 NON-STANDARDIZED ALLERGENIC IVA XANTHIFOLIA POLLEN Marshelder Burweed INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CYCLACHAENA XANTHIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1260_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1260 NON-STANDARDIZED ALLERGENIC IVA XANTHIFOLIA POLLEN Marshelder Burweed INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CYCLACHAENA XANTHIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1263_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1263 NON-STANDARDIZED ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Marshelder Rough INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA ANNUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1264_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1264 NON-STANDARDIZED ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Marshelder Rough INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1265_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1265 NON-STANDARDIZED ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Marshelder Rough INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA ANNUA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1266_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1266 NON-STANDARDIZED ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Marshelder Rough INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA ANNUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1273_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1273 NON-STANDARDIZED ALLERGENIC MELALEUCA QUINQUENERVIA POLLEN Melaleuca Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MELALEUCA QUINQUENERVIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1274_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1274 NON-STANDARDIZED ALLERGENIC MELALEUCA QUINQUENERVIA POLLEN Melaleuca Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MELALEUCA QUINQUENERVIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1275_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1275 NON-STANDARDIZED ALLERGENIC MELALEUCA QUINQUENERVIA POLLEN Melaleuca Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MELALEUCA QUINQUENERVIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1276_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1276 NON-STANDARDIZED ALLERGENIC MELALEUCA QUINQUENERVIA POLLEN Melaleuca Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MELALEUCA QUINQUENERVIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1277_356d3b28-7f35-4b8d-965e-dc8fc14856f3 0268-1277 NON-STANDARDIZED ALLERGENIC MELALEUCA MELALEUCA QUINQUENERVIA INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1279_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1279 NON-STANDARDIZED ALLERGENIC PROSOPIS JULIFLORA POLLEN Mesquite INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PROSOPIS JULIFLORA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1280_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1280 NON-STANDARDIZED ALLERGENIC PROSOPIS JULIFLORA POLLEN Mesquite INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1281_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1281 NON-STANDARDIZED ALLERGENIC PROSOPIS JULIFLORA POLLEN Mesquite INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PROSOPIS JULIFLORA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1297_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1297 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Mugwort Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1298_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1298 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Mugwort Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1299_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1299 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Mugwort Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1300_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1300 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Mugwort Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1301_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1301 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Mugwort Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1302_356d3b28-7f35-4b8d-965e-dc8fc14856f3 0268-1302 NON-STANDARDIZED ALLERGENIC SORREL/DOCK MIX RUMEX ACETOSELLA and RUMEX CRISPUS INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA WHOLE; RUMEX CRISPUS TOP .05; .05 g/mL; g/mL N 20181231 0268-1302_8a6ef994-deb3-428e-8792-79ac0515885c 0268-1302 NON-STANDARDIZED ALLERGENIC SORREL/DOCK MIX RUMEX ACETOSELLA POLLEN and RUMEX CRISPUS POLLEN INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1302_bdbd5a26-7d68-4b38-b50d-19cb2d40e29a 0268-1302 NON-STANDARDIZED ALLERGENIC SORREL/DOCK MIX RUMEX ACETOSELLA POLLEN and RUMEX CRISPUS POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1304_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1304 NON-STANDARDIZED ALLERGENIC MORUS RUBRA POLLEN Mulberry Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1305_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1305 NON-STANDARDIZED ALLERGENIC MORUS RUBRA POLLEN Mulberry Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1306_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1306 NON-STANDARDIZED ALLERGENIC MORUS RUBRA POLLEN Mulberry Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1307_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1307 NON-STANDARDIZED ALLERGENIC MORUS RUBRA POLLEN Mulberry Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1310_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1310 NON-STANDARDIZED ALLERGENIC MORUS ALBA POLLEN Mulberry White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1311_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1311 NON-STANDARDIZED ALLERGENIC MORUS ALBA POLLEN Mulberry White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1314_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1314 NON-STANDARDIZED ALLERGENIC QUERCUS AGRIFOLIA POLLEN Oak California Live Coast INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS AGRIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1315_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1315 NON-STANDARDIZED ALLERGENIC QUERCUS AGRIFOLIA POLLEN Oak California Live Coast INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1318_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1318 NON-STANDARDIZED ALLERGENIC QUERCUS RUBRA POLLEN Oak Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS RUBRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1319_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1319 NON-STANDARDIZED ALLERGENIC QUERCUS RUBRA POLLEN Oak Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1322_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1322 NON-STANDARDIZED ALLERGENIC QUERCUS VIRGINIANA POLLEN Oak Virginia Live INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1323_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1323 NON-STANDARDIZED ALLERGENIC QUERCUS VIRGINIANA POLLEN Oak Virginia Live INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1324_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1324 NON-STANDARDIZED ALLERGENIC QUERCUS VIRGINIANA POLLEN Oak Virginia Live INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS VIRGINIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1327_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1327 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1328_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1328 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1329_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1329 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1330_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1330 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1331_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1331 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1332_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1332 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 50000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1333_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1333 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1336_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1336 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oat Wild Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1339_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1339 NON-STANDARDIZED ALLERGENIC OLEA EUROPAEA POLLEN Olive Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1340_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1340 NON-STANDARDIZED ALLERGENIC OLEA EUROPAEA POLLEN Olive Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1347_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1347 NON-STANDARDIZED ALLERGENIC SYAGRUS ROMANZOFFIANA POLLEN Palm Queen Coco Palm INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SYAGRUS ROMANZOFFIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1348_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1348 NON-STANDARDIZED ALLERGENIC SYAGRUS ROMANZOFFIANA POLLEN Palm Queen Coco Palm INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1354_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1354 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1355_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1355 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1356_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1356 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1357_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1357 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1358_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1358 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1361_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1361 NON-STANDARDIZED ALLERGENIC SCHINUS MOLLE POLLEN Pepper Tree California INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1364_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1364 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1365_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1365 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1366_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1366 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1367_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1367 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1368_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1368 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1371_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1371 NON-STANDARDIZED ALLERGENIC AMARANTHUS SPINOSUS POLLEN Pigweed Spiny INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS SPINOSUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1372_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1372 NON-STANDARDIZED ALLERGENIC AMARANTHUS SPINOSUS POLLEN Pigweed Spiny INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS SPINOSUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1373_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1373 NON-STANDARDIZED ALLERGENIC AMARANTHUS SPINOSUS POLLEN Pigweed Spiny INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS SPINOSUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1376_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1376 NON-STANDARDIZED ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Pine Australian Beefwood INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CASUARINA EQUISETIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1377_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1377 NON-STANDARDIZED ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Pine Australian Beefwood INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CASUARINA EQUISETIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1378_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1378 NON-STANDARDIZED ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Pine Australian Beefwood INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CASUARINA EQUISETIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1379_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1379 NON-STANDARDIZED ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Pine Australian Beefwood INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CASUARINA EQUISETIFOLIA POLLEN 50000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1382_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1382 NON-STANDARDIZED ALLERGENIC PINUS STROBUS POLLEN Pine White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS STROBUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1383_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1383 NON-STANDARDIZED ALLERGENIC PINUS STROBUS POLLEN Pine White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS STROBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1384_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1384 NON-STANDARDIZED ALLERGENIC PINUS STROBUS POLLEN Pine White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS STROBUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1385_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1385 NON-STANDARDIZED ALLERGENIC PINUS STROBUS POLLEN Pine White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS STROBUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1386_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1386 NON-STANDARDIZED ALLERGENIC PINUS STROBUS POLLEN Pine White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS STROBUS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1389_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1389 NON-STANDARDIZED ALLERGENIC PINUS ECHINATA POLLEN Pine Yellow INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS ECHINATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1390_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1390 NON-STANDARDIZED ALLERGENIC PINUS ECHINATA POLLEN Pine Yellow INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS ECHINATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1394_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1394 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1395_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1395 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1396_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1396 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1397_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1397 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 100 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1398_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1398 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1399_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1399 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1400_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1400 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1401_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1401 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 10 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1402_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1402 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1405_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1405 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN Poplar White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1406_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1406 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN Poplar White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1407_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1407 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN Poplar White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1408_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1408 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN Poplar White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN .005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1409_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1409 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN Poplar White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN .0005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1412_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1412 NON-STANDARDIZED ALLERGENIC LIGUSTRUM VULGARE POLLEN Privet INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIGUSTRUM VULGARE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1413_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1413 NON-STANDARDIZED ALLERGENIC LIGUSTRUM VULGARE POLLEN Privet INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1414_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1414 NON-STANDARDIZED ALLERGENIC LIGUSTRUM VULGARE POLLEN Privet INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIGUSTRUM VULGARE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1415_c12525ee-2e21-4ac1-ba59-2ac3bd7cc270 0268-1415 NON-STANDARDIZED ALLERGENIC SHAGBARK HICKORY SHAGBARK HICKORY INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1416_c12525ee-2e21-4ac1-ba59-2ac3bd7cc270 0268-1416 NON-STANDARDIZED ALLERGENIC MIXED RAGWEED MIXED RAGWEED INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN 10000; 10000 [PNU]/mL; [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1417_c12525ee-2e21-4ac1-ba59-2ac3bd7cc270 0268-1417 NON-STANDARDIZED ALLERGENIC MIXED RAGWEED MIXED RAGWEED INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 20150503 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN .1; .1 g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1418_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1418 NON-STANDARDIZED ALLERGENIC ELYMUS REPENS POLLEN Quack Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ELYMUS REPENS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1419_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1419 NON-STANDARDIZED ALLERGENIC ELYMUS REPENS POLLEN Quack Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1420_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1420 NON-STANDARDIZED ALLERGENIC ELYMUS REPENS POLLEN Quack Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ELYMUS REPENS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1423_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1423 NON-STANDARDIZED ALLERGENIC AMBROSIA ACANTHICARPA POLLEN Ragweed False Bur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ACANTHICARPA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1424_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1424 NON-STANDARDIZED ALLERGENIC AMBROSIA ACANTHICARPA POLLEN Ragweed False Bur INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ACANTHICARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1431_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1431 NON-STANDARDIZED ALLERGENIC AMBROSIA TENUIFOLIA POLLEN Ragweed Slender INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TENUIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1432_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1432 NON-STANDARDIZED ALLERGENIC AMBROSIA TENUIFOLIA POLLEN Ragweed Slender INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TENUIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1435_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1435 NON-STANDARDIZED ALLERGENIC AMBROSIA BIDENTATA POLLEN Ragweed Southern INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA BIDENTATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1436_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1436 NON-STANDARDIZED ALLERGENIC AMBROSIA BIDENTATA POLLEN Ragweed Southern INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA BIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1439_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1439 NON-STANDARDIZED ALLERGENIC AMBROSIA TRIFIDA POLLEN Ragweed Tall Giant INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1440_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1440 NON-STANDARDIZED ALLERGENIC AMBROSIA TRIFIDA POLLEN Ragweed Tall Giant INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1441_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1441 NON-STANDARDIZED ALLERGENIC AMBROSIA TRIFIDA POLLEN Ragweed Tall Giant INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1442_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1442 NON-STANDARDIZED ALLERGENIC AMBROSIA TRIFIDA POLLEN Ragweed Tall Giant INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1445_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1445 NON-STANDARDIZED ALLERGENIC AMBROSIA PSILOSTACHYA POLLEN Ragweed Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA PSILOSTACHYA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1446_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1446 NON-STANDARDIZED ALLERGENIC AMBROSIA PSILOSTACHYA POLLEN Ragweed Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1453_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1453 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1454_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1454 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1455_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1455 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1456_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1456 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1457_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1457 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1460_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1460 NON-STANDARDIZED ALLERGENIC LOLIUM PERENNE SSP MULTIFLORUM POLLEN Rye Grass Italian INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LOLIUM MULTIFLORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1467_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1467 NON-STANDARDIZED ALLERGENIC ARTEMISIA FRIGIDA POLLEN Sage Prairie INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA FRIGIDA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1468_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1468 NON-STANDARDIZED ALLERGENIC ARTEMISIA FRIGIDA POLLEN Sage Prairie INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA FRIGIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1471_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1471 NON-STANDARDIZED ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Sagebrush Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA TRIDENTATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1472_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1472 NON-STANDARDIZED ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Sagebrush Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA TRIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1473_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1473 NON-STANDARDIZED ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Sagebrush Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA TRIDENTATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1476_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1476 NON-STANDARDIZED ALLERGENIC DISTICHLIS SPICATA POLLEN Salt Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. DISTICHLIS SPICATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1477_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1477 NON-STANDARDIZED ALLERGENIC DISTICHLIS SPICATA POLLEN Salt Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1480_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1480 NON-STANDARDIZED ALLERGENIC ATRIPLEX WRIGHTII POLLEN Saltbush Annual Atriplex INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ATRIPLEX WRIGHTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1481_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1481 NON-STANDARDIZED ALLERGENIC ATRIPLEX WRIGHTII POLLEN Saltbush Annual Atriplex INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ATRIPLEX WRIGHTII POLLEN .025 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1482_356d3b28-7f35-4b8d-965e-dc8fc14856f3 0268-1482 NON-STANDARDIZED ALLERGENIC LENSCALE ATRIPLEX LENTIFORMIS INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ATRIPLEX LENTIFORMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1493_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1493 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1494_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1494 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1495_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1495 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1496_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1496 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .0005 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1497_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1497 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1498_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1498 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1501_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1501 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN Sycamore American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1502_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1502 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN Sycamore American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1503_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1503 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN Sycamore American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1504_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1504 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN Sycamore American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1505_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1505 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN Sycamore American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1510_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1510 NON-STANDARDIZED ALLERGENIC HOLCUS LANATUS POLLEN Velvet Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOLCUS LANATUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1511_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1511 NON-STANDARDIZED ALLERGENIC HOLCUS LANATUS POLLEN Velvet Grass INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOLCUS LANATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1512_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1512 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN Walnut Black Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1513_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1513 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN Walnut Black Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1514_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1514 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN Walnut Black Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1515_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1515 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN Walnut California Black Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1516_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1516 NON-STANDARDIZED ALLERGENIC JUGLANS REGIA POLLEN Walnut English Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS REGIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1517_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1517 NON-STANDARDIZED ALLERGENIC JUGLANS REGIA POLLEN Walnut English Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS REGIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1518_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1518 NON-STANDARDIZED ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS TUBERCULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1519_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1519 NON-STANDARDIZED ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS TUBERCULATUS POLLEN .025 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1520_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1520 NON-STANDARDIZED ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS TUBERCULATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1521_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1521 NON-STANDARDIZED ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS TUBERCULATUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1522_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1522 NON-STANDARDIZED ALLERGENIC TRITICUM AESTIVUM POLLEN Wheat Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRITICUM AESTIVUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1523_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1523 NON-STANDARDIZED ALLERGENIC TRITICUM AESTIVUM POLLEN Wheat Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRITICUM AESTIVUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1524_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1524 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Willow Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1525_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1525 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Willow Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1526_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1526 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Willow Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1527_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1527 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Willow Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1528_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1528 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Willow Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN .001 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1529_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1529 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Willow Black INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1530_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1530 NON-STANDARDIZED ALLERGENIC ARTEMISIA ANNUA POLLEN Wormwood Common Annual INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1531_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1531 NON-STANDARDIZED ALLERGENIC AMBROSIA ARTEMISIIFOLIA POLLEN Ragweed Short INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN .1 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1532_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1532 NON-STANDARDIZED ALLERGENIC AMBROSIA ARTEMISIIFOLIA POLLEN Ragweed Short INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN .05 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1533_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1533 NON-STANDARDIZED ALLERGENIC AMBROSIA ARTEMISIIFOLIA POLLEN Ragweed Short INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1534_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1534 NON-STANDARDIZED ALLERGENIC AMBROSIA ARTEMISIIFOLIA POLLEN Ragweed Short INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 40000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1600_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1600 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN DOG EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1601_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1601 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN HORSE EPITHELIA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1602_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1602 NON-STANDARDIZED ALLERGENIC JUNIPERUS ASHEI POLLEN Cedar Mountain INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1603_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1603 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1604_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1604 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Cedar Red INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1605_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1605 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Cottonwood Eastern Common INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1606_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1606 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Dock Sour Sheep Sorrel INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 0268-1607_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1607 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN Elm American INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1608_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1608 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1609_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1609 NON-STANDARDIZED ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Juniper Western INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1610_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1610 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1612_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1612 NON-STANDARDIZED ALLERGENIC QUERCUS AGRIFOLIA POLLEN Oak California Live Coast INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1613_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1613 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Oak White INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1614_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1614 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1615_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1615 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Pigweed Rough Redroot INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-1616_8cd1ba48-174c-4aca-8eb9-c2d99b451026 0268-1616 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN Plantain English INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-2000_6199232a-c457-4b50-9112-794d25418367 0268-2000 HUMAN PRESCRIPTION DRUG Cat Hair, Standardized Cat Hair, Standardized INJECTION, SOLUTION SUBCUTANEOUS 20031128 BLA BLA103810 ALK-Abello, Inc. FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] N 20181231 0268-2001_6199232a-c457-4b50-9112-794d25418367 0268-2001 HUMAN PRESCRIPTION DRUG Cat Hair, Standardized Cat Hair, Standardized SOLUTION PERCUTANEOUS 20031128 BLA BLA103810 ALK-Abello, Inc. FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] N 20181231 0268-2002_55746080-edfc-4d38-9d49-85a4329bbd2c 0268-2002 HUMAN PRESCRIPTION DRUG Cat Pelt, Standardized Cat Pelt, Standardized SOLUTION PERCUTANEOUS 19920924 BLA BLA103061 ALK-Abello, Inc. FELIS CATUS SKIN 10000 [BAU]/mL Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3050_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3050 HUMAN PRESCRIPTION DRUG Bermuda Grass, Standardized Bermuda Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103051 ALK-Abello, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3051_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3051 HUMAN PRESCRIPTION DRUG Kentucky Bluegrass (June), Standardized Kentucky Bluegrass (June), Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103052 ALK-Abello, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3052_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3052 HUMAN PRESCRIPTION DRUG Kentucky Bluegrass (June), Standardized Kentucky Bluegrass (June), Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103052 ALK-Abello, Inc. POA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3053_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3053 HUMAN PRESCRIPTION DRUG Meadow Fescue Grass, Standardized Meadow Fescue Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103053 ALK-Abello, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3054_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3054 HUMAN PRESCRIPTION DRUG Meadow Fescue Grass, Standardized Meadow Fescue Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103053 ALK-Abello, Inc. FESTUCA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3055_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3055 HUMAN PRESCRIPTION DRUG Orchard Grass, Standardized Orchard Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103054 ALK-Abello, Inc. ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3056_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3056 HUMAN PRESCRIPTION DRUG Orchard Grass, Standardized Orchard Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103054 ALK-Abello, Inc. ALLERGENIC EXTRACT- ORCHARD GRASS DACTYLIS GLOMERATA 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3057_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3057 HUMAN PRESCRIPTION DRUG Redtop Grass, Standardized Redtop Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103055 ALK-Abello, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3058_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3058 HUMAN PRESCRIPTION DRUG Redtop Grass, Standardized Redtop Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103055 ALK-Abello, Inc. AGROSTIS GIGANTEA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3059_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3059 HUMAN PRESCRIPTION DRUG Rye Grass, Perennial Standardized Rye Grass, Perennial Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103056 ALK-Abello, Inc. ALLERGENIC EXTRACT- RYEGRASS, PERENNIAL LOLIUM PERENNE 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3060_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3060 HUMAN PRESCRIPTION DRUG Rye Grass, Perennial Standardized Rye Grass, Perennial Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103056 ALK-Abello, Inc. ALLERGENIC EXTRACT- RYEGRASS, PERENNIAL LOLIUM PERENNE 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3061_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3061 HUMAN PRESCRIPTION DRUG Sweet Vernal Grass, Standardized Sweet Vernal Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103057 ALK-Abello, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3062_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3062 HUMAN PRESCRIPTION DRUG Sweet Vernal Grass, Standardized Sweet Vernal Grass, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103057 ALK-Abello, Inc. ANTHOXANTHUM ODORATUM POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3063_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3063 HUMAN PRESCRIPTION DRUG Timothy, Standardized Timothy, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-3064_13f1ef62-876b-4a9f-90cd-bb7e307157e9 0268-3064 HUMAN PRESCRIPTION DRUG Timothy, Standardized Timothy, Standardized SOLUTION PERCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6000_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6000 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 10000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] N 20181231 0268-6001_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6001 NON-STANDARDIZED ALLERGENIC HOUSE DUST House Dust INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. HOUSE DUST 1000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] N 20181231 0268-6100_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6100 NON-STANDARDIZED ALLERGENIC ALMOND ALMOND INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ALMOND .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-6100_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6100 NON-STANDARDIZED ALLERGENIC ALMOND Almond Food INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALMOND .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-6101_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6101 NON-STANDARDIZED ALLERGENIC APPLE APPLE INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. APPLE .1 mg/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-6101_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6101 NON-STANDARDIZED ALLERGENIC APPLE Apple Food INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. APPLE .1 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-6102_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6102 NON-STANDARDIZED ALLERGENIC APRICOT APRICOT INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. APRICOT .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6102_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6102 NON-STANDARDIZED ALLERGENIC APRICOT Apricot INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. APRICOT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6103_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6103 NON-STANDARDIZED ALLERGENIC ASPARAGUS ASPARAGUS INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ASPARAGUS .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6103_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6103 NON-STANDARDIZED ALLERGENIC ASPARAGUS Asparagus INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPARAGUS .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6104_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6104 NON-STANDARDIZED ALLERGENIC AVOCADO AVOCADO INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. AVOCADO .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6104_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6104 NON-STANDARDIZED ALLERGENIC AVOCADO Avocado INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AVOCADO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6105_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6105 NON-STANDARDIZED ALLERGENIC BANANA BANANA INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. BANANA .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6105_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6105 NON-STANDARDIZED ALLERGENIC BANANA Banana INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BANANA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6106_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6106 NON-STANDARDIZED ALLERGENIC BARLEY BARLEY INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. BARLEY .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6106_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6106 NON-STANDARDIZED ALLERGENIC BARLEY Barley Food INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BARLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6107_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6107 NON-STANDARDIZED ALLERGENIC KIDNEY BEAN KIDNEY BEAN INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. KIDNEY BEAN .1 mg/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6107_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6107 NON-STANDARDIZED ALLERGENIC BEAN Pinto Bean Kidney Bean INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6108_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6108 NON-STANDARDIZED ALLERGENIC STRING BEAN STRING BEAN INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. STRING BEAN .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6108_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6108 NON-STANDARDIZED ALLERGENIC STRING BEAN String Bean Green Bean INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STRING BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6109_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6109 NON-STANDARDIZED ALLERGENIC BEEF BEEF INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. BEEF .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 0268-6109_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6109 NON-STANDARDIZED ALLERGENIC BEEF Beef INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BEEF .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 0268-6110_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6110 NON-STANDARDIZED ALLERGENIC BRAZIL NUT BRAZIL NUT INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. BRAZIL NUT .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-6110_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6110 NON-STANDARDIZED ALLERGENIC BRAZIL NUT Brazil Nut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BRAZIL NUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-6112_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6112 NON-STANDARDIZED ALLERGENIC BROCCOLI BROCCOLI INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. BROCCOLI .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6112_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6112 NON-STANDARDIZED ALLERGENIC BROCCOLI Broccoli INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BROCCOLI .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6113_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6113 NON-STANDARDIZED ALLERGENIC BUCKWHEAT BUCKWHEAT INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. BUCKWHEAT .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6113_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6113 NON-STANDARDIZED ALLERGENIC BUCKWHEAT Buckwheat INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BUCKWHEAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6114_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6114 NON-STANDARDIZED ALLERGENIC CABBAGE CABBAGE INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CABBAGE .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6114_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6114 NON-STANDARDIZED ALLERGENIC CABBAGE Cabbage INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CABBAGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6115_b76b8517-eea0-4596-ae41-4cbc38bb9cfa 0268-6115 NON-STANDARDIZED ALLERGENIC CANTALOUPE CANTALOUPE INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CANTALOUPE .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6115_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6115 NON-STANDARDIZED ALLERGENIC CANTALOUPE Cantaloupe INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANTALOUPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6116_26681b50-ec54-402a-bef2-409d1350340d 0268-6116 NON-STANDARDIZED ALLERGENIC CARROT CARROT INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CARROT .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6116_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6116 NON-STANDARDIZED ALLERGENIC CARROT Carrot INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARROT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6118_26681b50-ec54-402a-bef2-409d1350340d 0268-6118 NON-STANDARDIZED ALLERGENIC CASEIN CASEIN INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CASEIN .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] N 20181231 0268-6118_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6118 NON-STANDARDIZED ALLERGENIC CASEIN Casein INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CASEIN .01 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] N 20181231 0268-6120_26681b50-ec54-402a-bef2-409d1350340d 0268-6120 NON-STANDARDIZED ALLERGENIC CELERY CELERY INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CELERY .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6120_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6120 NON-STANDARDIZED ALLERGENIC CELERY Celery INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CELERY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6121_26681b50-ec54-402a-bef2-409d1350340d 0268-6121 NON-STANDARDIZED ALLERGENIC CHERRY CHERRY INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CHERRY .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6121_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6121 NON-STANDARDIZED ALLERGENIC CHERRY Cherry INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6122_26681b50-ec54-402a-bef2-409d1350340d 0268-6122 NON-STANDARDIZED ALLERGENIC CHICKEN MEAT CHICKEN INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CHICKEN .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] N 20181231 0268-6122_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6122 NON-STANDARDIZED ALLERGENIC CHICKEN Chicken Meat INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHICKEN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] N 20181231 0268-6123_26681b50-ec54-402a-bef2-409d1350340d 0268-6123 NON-STANDARDIZED ALLERGENIC CINNAMON CINNAMON INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CINNAMON .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6123_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6123 NON-STANDARDIZED ALLERGENIC CINNAMON Cinnamon INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CINNAMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6124_26681b50-ec54-402a-bef2-409d1350340d 0268-6124 NON-STANDARDIZED ALLERGENIC CLAM NORTHERN QUAHOG INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. NORTHERN QUAHOG .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 0268-6124_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6124 NON-STANDARDIZED ALLERGENIC CLAM Clam INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLAM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 0268-6125_26681b50-ec54-402a-bef2-409d1350340d 0268-6125 NON-STANDARDIZED ALLERGENIC COCOA BEAN COCOA INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. COCOA .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6125_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6125 NON-STANDARDIZED ALLERGENIC COCOA BEAN Cocoa Bean Whole Bean Chocolate INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCOA BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6127_26681b50-ec54-402a-bef2-409d1350340d 0268-6127 NON-STANDARDIZED ALLERGENIC COCONUT COCONUT INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. COCONUT .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6127_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6127 NON-STANDARDIZED ALLERGENIC COCONUT Coconut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCONUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6128_26681b50-ec54-402a-bef2-409d1350340d 0268-6128 NON-STANDARDIZED ALLERGENIC CODFISH ATLANTIC COD INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ATLANTIC COD .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 0268-6128_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6128 NON-STANDARDIZED ALLERGENIC CODFISH Codfish INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CODFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 0268-6129_26681b50-ec54-402a-bef2-409d1350340d 0268-6129 NON-STANDARDIZED ALLERGENIC COFFEE COFFEE BEAN INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. COFFEE BEAN .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6129_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6129 NON-STANDARDIZED ALLERGENIC COFFEE BEAN Coffee INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COFFEE BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6130_26681b50-ec54-402a-bef2-409d1350340d 0268-6130 NON-STANDARDIZED ALLERGENIC CRAB RED KING CRAB INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. RED KING CRAB .1 mg/mL N 20181231 0268-6130_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6130 NON-STANDARDIZED ALLERGENIC CRAB Crab INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CRAB .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 0268-6132_26681b50-ec54-402a-bef2-409d1350340d 0268-6132 NON-STANDARDIZED ALLERGENIC CUCUMBER CUCUMBER INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CUCUMBER .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6132_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6132 NON-STANDARDIZED ALLERGENIC CUCUMBER Cucumber INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CUCUMBER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6133_26681b50-ec54-402a-bef2-409d1350340d 0268-6133 NON-STANDARDIZED ALLERGENIC EGG WHITE EGG WHITE INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. EGG WHITE .1 mg/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] N 20181231 0268-6133_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6133 NON-STANDARDIZED ALLERGENIC EGG WHITE Egg White INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EGG WHITE .01 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] N 20181231 0268-6135_26681b50-ec54-402a-bef2-409d1350340d 0268-6135 NON-STANDARDIZED ALLERGENIC EGG, WHOLE EGG INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. EGG .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] N 20181231 0268-6135_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6135 NON-STANDARDIZED ALLERGENIC EGG Whole Egg INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EGG .01 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] N 20181231 0268-6136_a966cada-cb23-416e-96b1-86ef928568d6 0268-6136 NON-STANDARDIZED ALLERGENIC EGG YOLK EGG YOLK INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. EGG YOLK .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] N 20181231 0268-6136_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6136 NON-STANDARDIZED ALLERGENIC EGG YOLK Egg Yolk INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EGG YOLK .01 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] N 20181231 0268-6137_a966cada-cb23-416e-96b1-86ef928568d6 0268-6137 NON-STANDARDIZED ALLERGENIC FLOUNDER SOUTHERN FLOUNDER INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. SOUTHERN FLOUNDER .1 mg/mL N 20181231 0268-6137_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6137 NON-STANDARDIZED ALLERGENIC FLOUNDER Flounder INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FLOUNDER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 0268-6138_a966cada-cb23-416e-96b1-86ef928568d6 0268-6138 NON-STANDARDIZED ALLERGENIC GARLIC GARLIC INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. GARLIC .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6138_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6138 NON-STANDARDIZED ALLERGENIC GARLIC Garlic INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GARLIC .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6139_a2a5335c-bf34-484a-a605-c58d601fe326 0268-6139 NON-STANDARDIZED ALLERGENIC VITIS SPP WHITE GRAPE GRAPE INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. GRAPE .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6139_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6139 NON-STANDARDIZED ALLERGENIC GRAPE White Seedless Grape INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GRAPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6141_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6141 NON-STANDARDIZED ALLERGENIC GRAPEFRUIT Grapefruit INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GRAPEFRUIT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6143_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6143 NON-STANDARDIZED ALLERGENIC KARAYA GUM Karaya Gum Bassora INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. KARAYA GUM .005 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6146_a966cada-cb23-416e-96b1-86ef928568d6 0268-6146 NON-STANDARDIZED ALLERGENIC HONEYDEW HONEYDEW MELON INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. HONEYDEW MELON .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6146_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6146 NON-STANDARDIZED ALLERGENIC HONEYDEW MELON Honeydew INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HONEYDEW MELON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6149_a966cada-cb23-416e-96b1-86ef928568d6 0268-6149 NON-STANDARDIZED ALLERGENIC LAMB LAMB INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. LAMB .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 0268-6149_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6149 NON-STANDARDIZED ALLERGENIC LAMB Lamb INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LAMB .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 0268-6170_a966cada-cb23-416e-96b1-86ef928568d6 0268-6170 NON-STANDARDIZED ALLERGENIC LEMON LEMON INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. LEMON .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6170_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6170 NON-STANDARDIZED ALLERGENIC LEMON Lemon INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LEMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6171_a966cada-cb23-416e-96b1-86ef928568d6 0268-6171 NON-STANDARDIZED ALLERGENIC LETTUCE LETTUCE INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. LETTUCE .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6171_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6171 NON-STANDARDIZED ALLERGENIC LETTUCE Lettuce INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LETTUCE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6173_a966cada-cb23-416e-96b1-86ef928568d6 0268-6173 NON-STANDARDIZED ALLERGENIC LIMA BEAN LIMA BEAN INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. LIMA BEAN .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6173_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6173 NON-STANDARDIZED ALLERGENIC LIMA BEAN Lima Bean INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIMA BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6174_a966cada-cb23-416e-96b1-86ef928568d6 0268-6174 NON-STANDARDIZED ALLERGENIC LOBSTER AMERICAN LOBSTER INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. AMERICAN LOBSTER .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 0268-6174_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6174 NON-STANDARDIZED ALLERGENIC LOBSTER Lobster INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LOBSTER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 0268-6177_a966cada-cb23-416e-96b1-86ef928568d6 0268-6177 NON-STANDARDIZED ALLERGENIC GOATS MILK GOAT MILK INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. GOAT MILK .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] N 20181231 0268-6177_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6177 NON-STANDARDIZED ALLERGENIC GOAT MILK Goat Milk INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GOAT MILK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] N 20181231 0268-6178_a966cada-cb23-416e-96b1-86ef928568d6 0268-6178 NON-STANDARDIZED ALLERGENIC COWS MILK COW MILK INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. COW MILK .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] N 20181231 0268-6178_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6178 NON-STANDARDIZED ALLERGENIC COW MILK Milk Whole Cows INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COW MILK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] N 20181231 0268-6180_a966cada-cb23-416e-96b1-86ef928568d6 0268-6180 NON-STANDARDIZED ALLERGENIC MUSHROOM CULTIVATED MUSHROOM INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CULTIVATED MUSHROOM .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20181231 0268-6180_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6180 NON-STANDARDIZED ALLERGENIC MUSHROOM Mushroom Agaricus spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CULTIVATED MUSHROOM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20181231 0268-6181_a966cada-cb23-416e-96b1-86ef928568d6 0268-6181 NON-STANDARDIZED ALLERGENIC MUSTARD MUSTARD SEED INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. MUSTARD SEED .1 mg/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 0268-6181_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6181 NON-STANDARDIZED ALLERGENIC MUSTARD SEED Mustard Seed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUSTARD SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 0268-6183_a966cada-cb23-416e-96b1-86ef928568d6 0268-6183 NON-STANDARDIZED ALLERGENIC OAT GRAIN OAT INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. OAT .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6183_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6183 NON-STANDARDIZED ALLERGENIC OAT Oat Grain INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. OAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6185_a966cada-cb23-416e-96b1-86ef928568d6 0268-6185 NON-STANDARDIZED ALLERGENIC OLIVE BLACK OLIVE INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. BLACK OLIVE .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6185_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6185 NON-STANDARDIZED ALLERGENIC BLACK OLIVE Olive INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLACK OLIVE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6186_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6186 NON-STANDARDIZED ALLERGENIC ONION ONION INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ONION .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6186_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6186 NON-STANDARDIZED ALLERGENIC ONION Onion INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ONION .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6187_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6187 NON-STANDARDIZED ALLERGENIC ORANGE ORANGE INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ORANGE .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6187_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6187 NON-STANDARDIZED ALLERGENIC ORANGE Orange INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ORANGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6189_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6189 NON-STANDARDIZED ALLERGENIC OYSTER EASTERN OYSTER INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. EASTERN OYSTER .1 mg/mL N 20181231 0268-6189_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6189 NON-STANDARDIZED ALLERGENIC OYSTER Oyster INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. OYSTER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 0268-6191_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6191 NON-STANDARDIZED ALLERGENIC GREEN PEA PEA INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. PEA .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6191_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6191 NON-STANDARDIZED ALLERGENIC PEA Green Pea English INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6192_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6192 NON-STANDARDIZED ALLERGENIC PEACH PEACH INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. PEACH .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6192_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6192 NON-STANDARDIZED ALLERGENIC PEACH Peach INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PEACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6193_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6193 NON-STANDARDIZED ALLERGENIC PEANUT PEANUT INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. PEANUT .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-6193_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6193 NON-STANDARDIZED ALLERGENIC PEANUT Peanut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PEANUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-6195_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6195 NON-STANDARDIZED ALLERGENIC PEAR PEAR INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. PEAR .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6195_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6195 NON-STANDARDIZED ALLERGENIC PEAR Pear INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PEAR .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6196_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6196 NON-STANDARDIZED ALLERGENIC PECAN NUT PECAN INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. PECAN .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-6196_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6196 NON-STANDARDIZED ALLERGENIC PECAN Pecan INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PECAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-6197_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6197 NON-STANDARDIZED ALLERGENIC BELL PEPPER GREEN BELL PEPPER INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. GREEN BELL PEPPER .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6197_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6197 NON-STANDARDIZED ALLERGENIC GREEN BELL PEPPER Bell INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GREEN BELL PEPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6198_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6198 NON-STANDARDIZED ALLERGENIC BLACK PEPPER BLACK PEPPER INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. BLACK PEPPER .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6198_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6198 NON-STANDARDIZED ALLERGENIC BLACK PEPPER Black Pepper INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLACK PEPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6200_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6200 NON-STANDARDIZED ALLERGENIC PINEAPPLE PINEAPPLE INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. PINEAPPLE .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6200_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6200 NON-STANDARDIZED ALLERGENIC PINEAPPLE Pineapple INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINEAPPLE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6202_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6202 NON-STANDARDIZED ALLERGENIC PISTACHIO NUT PISTACHIO INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. PISTACHIO .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-6202_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6202 NON-STANDARDIZED ALLERGENIC PISTACHIO Pistachio Nut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PISTACHIO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-6203_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6203 NON-STANDARDIZED ALLERGENIC PLUM PLUM INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. PLUM .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6203_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6203 NON-STANDARDIZED ALLERGENIC PLUM Plum INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLUM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6204_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6204 NON-STANDARDIZED ALLERGENIC PORK PORK INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. PORK .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 0268-6204_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6204 NON-STANDARDIZED ALLERGENIC PORK Pork INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PORK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 0268-6205_b5997c82-efde-4f24-b7d3-a2d65bb50997 0268-6205 NON-STANDARDIZED ALLERGENIC SWEET POTATO SWEET POTATO INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. SWEET POTATO .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6205_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6205 NON-STANDARDIZED ALLERGENIC POTATO Sweet Potato INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6206_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6206 NON-STANDARDIZED ALLERGENIC WHITE POTATO POTATO INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. POTATO .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6206_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6206 NON-STANDARDIZED ALLERGENIC POTATO White Potato INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6208_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6208 NON-STANDARDIZED ALLERGENIC RICE BROWN RICE INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. BROWN RICE .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6208_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6208 NON-STANDARDIZED ALLERGENIC RICE Rice INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RICE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6210_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6210 NON-STANDARDIZED ALLERGENIC RYE GRAIN RYE INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. RYE .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6210_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6210 NON-STANDARDIZED ALLERGENIC RYE Rye INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RYE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6212_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6212 NON-STANDARDIZED ALLERGENIC SALMON ATLANTIC SALMON INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ATLANTIC SALMON .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 0268-6212_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6212 NON-STANDARDIZED ALLERGENIC SALMON Salmon INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 0268-6213_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6213 NON-STANDARDIZED ALLERGENIC SESAME SEED SESAME SEED INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. SESAME SEED .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6213_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6213 NON-STANDARDIZED ALLERGENIC SESAME SEED Sesame Seed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SESAME SEED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6214_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6214 NON-STANDARDIZED ALLERGENIC SHRIMP COMMON SHRIMP INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. COMMON SHRIMP .1 mg/mL N 20181231 0268-6214_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6214 NON-STANDARDIZED ALLERGENIC SHRIMP Shrimp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SHRIMP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 0268-6216_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6216 NON-STANDARDIZED ALLERGENIC SOYBEAN SOYBEAN INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. SOYBEAN .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6216_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6216 NON-STANDARDIZED ALLERGENIC SOYBEAN Soybean INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOYBEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6218_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6218 NON-STANDARDIZED ALLERGENIC SPINACH SPINACH INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. SPINACH .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6218_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6218 NON-STANDARDIZED ALLERGENIC SPINACH Spinach INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SPINACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6219_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6219 NON-STANDARDIZED ALLERGENIC SQUASH SQUASH INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. SQUASH .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6219_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6219 NON-STANDARDIZED ALLERGENIC SQUASH Squash INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SQUASH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6220_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6220 NON-STANDARDIZED ALLERGENIC STRAWBERRY STRAWBERRY INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. STRAWBERRY .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6220_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6220 NON-STANDARDIZED ALLERGENIC STRAWBERRY Strawberry INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STRAWBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6221_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6221 NON-STANDARDIZED ALLERGENIC SWEET CORN CORN INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CORN .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6221_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6221 NON-STANDARDIZED ALLERGENIC CORN Sweet Corn INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6224_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6224 NON-STANDARDIZED ALLERGENIC TOMATO TOMATO INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. TOMATO .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6224_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6224 NON-STANDARDIZED ALLERGENIC TOMATO Tomato INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TOMATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 0268-6226_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6226 NON-STANDARDIZED ALLERGENIC TUNA NORTHERN BLUEFIN TUNA INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. NORTHERN BLUEFIN TUNA .1 mg/mL N 20181231 0268-6226_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6226 NON-STANDARDIZED ALLERGENIC TUNA Tuna INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TUNA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 0268-6229_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6229 NON-STANDARDIZED ALLERGENIC TURKEY TURKEY INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. TURKEY .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] N 20181231 0268-6229_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6229 NON-STANDARDIZED ALLERGENIC TURKEY Turkey Meat INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TURKEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] N 20181231 0268-6230_a2a5335c-bf34-484a-a605-c58d601fe326 0268-6230 NON-STANDARDIZED ALLERGENIC VANILLA VANILLA INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. VANILLA .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6230_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6230 NON-STANDARDIZED ALLERGENIC VANILLA Vanilla INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. VANILLA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6231_a2a5335c-bf34-484a-a605-c58d601fe326 0268-6231 NON-STANDARDIZED ALLERGENIC ENGLISH WALNUT ENGLISH WALNUT INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ENGLISH WALNUT .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-6231_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6231 NON-STANDARDIZED ALLERGENIC ENGLISH WALNUT English Walnut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ENGLISH WALNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-6233_a2a5335c-bf34-484a-a605-c58d601fe326 0268-6233 NON-STANDARDIZED ALLERGENIC WATERMELON WATERMELON INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. WATERMELON .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6233_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6233 NON-STANDARDIZED ALLERGENIC WATERMELON Watermelon INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. WATERMELON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 0268-6234_a2a5335c-bf34-484a-a605-c58d601fe326 0268-6234 NON-STANDARDIZED ALLERGENIC WHEAT GRAIN WHEAT INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. WHEAT .1 mg/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6234_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6234 NON-STANDARDIZED ALLERGENIC WHEAT Whole Wheat Wheat Grain INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. WHEAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 0268-6235_32903953-475f-49d7-a5cb-70e1381d27c6 0268-6235 NON-STANDARDIZED ALLERGENIC THEA SIRENSIS TEA TEA LEAF INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. TEA LEAF .1 mg/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6235_3b01d902-8d34-404a-b126-5e01659e9e35 0268-6235 NON-STANDARDIZED ALLERGENIC THEA SIRENSIS THEA SIRENSIS INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TEA LEAF .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6300_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6300 NON-STANDARDIZED ALLERGENIC BOS TAURUS SKIN Cattle Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOS TAURUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6301_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6301 NON-STANDARDIZED ALLERGENIC BOS TAURUS SKIN Cattle Epithelium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BOS TAURUS SKIN 1000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6302_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6302 NON-STANDARDIZED ALLERGENIC COTTON FIBER Cattle Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COTTON FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6303_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6303 NON-STANDARDIZED ALLERGENIC COTTON FIBER Cotton Linters INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. COTTON FIBER .001 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6304_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6304 NON-STANDARDIZED ALLERGENIC COTTON SEED Cottonseed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COTTON SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 0268-6305_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6305 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN Dog Epithelium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN 1000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6306_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6306 NON-STANDARDIZED ALLERGENIC CANIS LUPUS FAMILIARIS SKIN Dog Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANIS LUPUS FAMILIARIS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6308_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6308 NON-STANDARDIZED ALLERGENIC CAVIA PORCELLUS SKIN Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CAVIA PORCELLUS SKIN 1000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6309_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6309 NON-STANDARDIZED ALLERGENIC CAVIA PORCELLUS SKIN Guinea Pig Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CAVIA PORCELLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6310_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6310 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN Horse Epithelium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN 1000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6311_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6311 NON-STANDARDIZED ALLERGENIC EQUUS CABALLUS SKIN Horse Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EQUUS CABALLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6312_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6312 NON-STANDARDIZED ALLERGENIC CEIBA PENTANDRA FIBER Kapok INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CEIBA PENTANDRA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6314_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6314 NON-STANDARDIZED ALLERGENIC MUS MUSCULUS SKIN Mouse Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUS MUSCULUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6316_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6316 NON-STANDARDIZED ALLERGENIC MUS MUSCULUS SKIN Mouse Epithelium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. MUS MUSCULUS SKIN 1000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6317_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6317 NON-STANDARDIZED ALLERGENIC ORRIS Orris Root INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ORRIS .05 g/mL N 20181231 0268-6318_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6318 NON-STANDARDIZED ALLERGENIC PYRETHRUM CINERARIIFOLIUM Pyrethrum INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PYRETHRUM CINERARIIFOLIUM .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 0268-6319_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6319 NON-STANDARDIZED ALLERGENIC RABBIT Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. RABBIT 1000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 0268-6320_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6320 NON-STANDARDIZED ALLERGENIC RABBIT Rabbit Epithelium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RABBIT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 0268-6400_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6400 NON-STANDARDIZED ALLERGENIC SOLENOPSIS INVICTA Fire Ant INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLENOPSIS INVICTA .01 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6401_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6401 NON-STANDARDIZED ALLERGENIC SOLENOPSIS INVICTA Fire Ant INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. SOLENOPSIS INVICTA 10 [PNU]/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6402_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6402 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA American Cockroach INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA 100 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6403_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6403 NON-STANDARDIZED ALLERGENIC PERIPLANETA AMERICANA American Cockroach INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PERIPLANETA AMERICANA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6405_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6405 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA German Cockroach INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6407_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6407 NON-STANDARDIZED ALLERGENIC BLATELLA GERMANICA German Cockroach INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BLATELLA GERMANICA 100 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6500_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6500 NON-STANDARDIZED ALLERGENIC ACREMONIUM STRICTUM ACREMONIUM STRICTUM INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACREMONIUM STRICTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6501_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6501 NON-STANDARDIZED ALLERGENIC ACREMONIUM STRICTUM Acremonium Cephalosporium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ACREMONIUM STRICTUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6502_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6502 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS Alternaria tenuis A alternata INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6503_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6503 NON-STANDARDIZED ALLERGENIC ALTERNARIA TENUIS Alternaria tenuis A alternata INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6504_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6504 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS Aspergillus Fumigatus INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6506_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6506 NON-STANDARDIZED ALLERGENIC ASPERGILLUS FUMIGATUS Aspergillus Fumigatus INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FUMIGATUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6507_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6507 NON-STANDARDIZED ALLERGENIC ASPERGILLUS NIGER VAR NIGER Aspergillus Niger INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6508_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6508 NON-STANDARDIZED ALLERGENIC ASPERGILLUS NIGER VAR NIGER Aspergillus Niger INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6509_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6509 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS PULLULARIA PULLULANS INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6511_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6511 NON-STANDARDIZED ALLERGENIC AUREOBASIDIUM PULLULANS VAR PULLULANS Aureobasidium Pullularia Pullulans INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6512_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6512 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA Botrytis cinerea INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6513_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6513 NON-STANDARDIZED ALLERGENIC BOTRYTIS CINEREA Botrytis cinerea INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BOTRYTIS CINEREA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6514_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6514 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS Candida albicans INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS .1 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-6515_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6515 NON-STANDARDIZED ALLERGENIC CANDIDA ALBICANS Candida albicans INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CANDIDA ALBICANS 1000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 0268-6516_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6516 NON-STANDARDIZED ALLERGENIC CHAETOMIUM GLOBOSUM Chaetomium globosum INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHAETOMIUM GLOBOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6517_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6517 NON-STANDARDIZED ALLERGENIC CHAETOMIUM GLOBOSUM Chaetomium globosum INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CHAETOMIUM GLOBOSUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6518_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6518 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES Cladosporium Cladosporioides Hormodendrum Clad INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6519_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6519 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM CLADOSPORIOIDES Cladosporium Cladosporioides Hormodendrum Clad INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM CLADOSPORIOIDES 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6520_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6520 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM Cladosporium Sphaerospermum Hormodendrum Hordei INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6521_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6521 NON-STANDARDIZED ALLERGENIC CLADOSPORIUM SPHAEROSPERMUM Cladosporium Sphaerospermum Hormodendrum Hordei INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CLADOSPORIUM SPHAEROSPERMUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6524_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6524 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS HELMINTHOSPORIUM SOROKINIANUM INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6525_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6525 NON-STANDARDIZED ALLERGENIC COCHLIOBOLUS SATIVUS Drechslera Helminthosporium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6526_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6526 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM Epicoccum nigrum INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 0268-6528_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6528 NON-STANDARDIZED ALLERGENIC EPICOCCUM NIGRUM Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. EPICOCCUM NIGRUM 1000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 0268-6529_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6529 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM Fusarium spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6532_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6532 NON-STANDARDIZED ALLERGENIC FUSARIUM OXYSPORUM VASINFECTUM Fusarium spp INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. FUSARIUM OXYSPORUM VASINFECTUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6533_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6533 NON-STANDARDIZED ALLERGENIC HELMINTHOSPORIUM SOLANI Helminthosporium solani Spondylocladium INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HELMINTHOSPORIUM SOLANI .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6535_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6535 NON-STANDARDIZED ALLERGENIC HELMINTHOSPORIUM SOLANI Helminthosporium solani Spondylocladium INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. HELMINTHOSPORIUM SOLANI 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6536_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6536 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS Mucor spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6537_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6537 NON-STANDARDIZED ALLERGENIC MUCOR PLUMBEUS HelminthMucor spp INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. MUCOR PLUMBEUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6538_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6538 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA Neurospora spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6539_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6539 NON-STANDARDIZED ALLERGENIC NEUROSPORA INTERMEDIA Neurospora spp INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. NEUROSPORA INTERMEDIA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6540_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6540 NON-STANDARDIZED ALLERGENIC KHUSKIA ORYZAE Nigrospora spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. KHUSKIA ORYZAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6543_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6543 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA Phoma herbarum INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6544_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6544 NON-STANDARDIZED ALLERGENIC PHOMA EXIGUA VAR EXIGUA Phoma herbarum INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. PHOMA EXIGUA VAR. EXIGUA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6545_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6545 NON-STANDARDIZED ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS Rhizopus spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6547_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6547 NON-STANDARDIZED ALLERGENIC RHIZOPUS ARRHIZUS VAR ARRHIZUS Rhizopus spp INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6548_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6548 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA Rhodotorula Rubra INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6549_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6549 NON-STANDARDIZED ALLERGENIC RHODOTORULA RUBRA Rhodotorula Rubra INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. RHODOTORULA RUBRA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6550_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6550 NON-STANDARDIZED ALLERGENIC USTILAGO MAYDIS Corn Smut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. USTILAGO MAYDIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6552_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6552 NON-STANDARDIZED ALLERGENIC USTILAGO TRITICI Wheat Smut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. USTILAGO TRITICI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6553_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6553 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI Stemphylium spp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6555_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6555 NON-STANDARDIZED ALLERGENIC STEMPHYLIUM SOLANI Stemphylium spp INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. STEMPHYLIUM SOLANI 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6556_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6556 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES Trichophyton Mentagrophytes INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6557_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6557 NON-STANDARDIZED ALLERGENIC TRICHOPHYTON MENTAGROPHYTES Trichophyton Mentagrophytes INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. TRICHOPHYTON MENTAGROPHYTES 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6558_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6558 NON-STANDARDIZED ALLERGENIC PENICILLIUM CHRYSOGENUM VAR CHRYSOGENUM Yeast Saccharomyces cerevisiae INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6559_3b01d902-8d34-404a-b126-5e01659e9e35 0268-6559 NON-STANDARDIZED ALLERGENIC MIXED ASPERGILLUS MIXED ASPERGILLUS INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS TERREUS .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6560_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6560 NON-STANDARDIZED ALLERGENIC SACCHAROMYCES CEREVISIAE Yeast Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. SACCHAROMYCES CEREVISIAE 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20181231 0268-6600_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6600 NON-STANDARDIZED ALLERGENIC ACACIA Acacia INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACACIA .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6601_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6601 NON-STANDARDIZED ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN White Alder INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6602_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6602 NON-STANDARDIZED ALLERGENIC MEDICAGO SATIVA POLLEN Alfalfa INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MEDICAGO SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6603_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6603 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN White Ash INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6605_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6605 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6606_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6606 NON-STANDARDIZED ALLERGENIC MORELLA CERIFERA POLLEN Bayberry Wax Myrtle INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORELLA CERIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6607_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6607 NON-STANDARDIZED ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6608_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6608 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Black Birch INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6609_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6609 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN River Birch Red INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6610_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6610 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN White Birch INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6612_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6612 NON-STANDARDIZED ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6613_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6613 NON-STANDARDIZED ALLERGENIC AMARANTHUS PALMERI POLLEN Carelessweed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS PALMERI POLLEN .025 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6614_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6614 NON-STANDARDIZED ALLERGENIC JUNIPERUS ASHEI POLLEN Mountain Cedar INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6615_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6615 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Red Cedar INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6616_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6616 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6618_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6618 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Eastern Cottonwood Common INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6619_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6619 NON-STANDARDIZED ALLERGENIC CUPRESSUS ARIZONICA POLLEN Arizona Cypress INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6620_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6620 NON-STANDARDIZED ALLERGENIC TAXODIUM DISTICHUM POLLEN Bald Cypress INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TAXODIUM DISTICHUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6621_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6621 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Sour Dock Sheep Sorrel INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 0268-6622_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6622 NON-STANDARDIZED ALLERGENIC RUMEX CRISPUS POLLEN Yellow Dock INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX CRISPUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6623_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6623 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN American Elm INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6625_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6625 NON-STANDARDIZED ALLERGENIC SOLIDAGO CANADENSIS POLLEN Goldenrod INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6626_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6626 NON-STANDARDIZED ALLERGENIC CELTIS OCCIDENTALIS POLLEN Hackberry INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6627_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6627 NON-STANDARDIZED ALLERGENIC CARYA OVATA POLLEN Shagbark Hickory INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6629_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6629 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6630_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6630 NON-STANDARDIZED ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Western Juniper INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6631_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6631 NON-STANDARDIZED ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. KOCHIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6632_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6632 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6634_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6634 NON-STANDARDIZED ALLERGENIC ACER RUBRUM POLLEN Red Maple INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER RUBRUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6635_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6635 NON-STANDARDIZED ALLERGENIC ACER SACCHARUM POLLEN Sugar Maple INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6636_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6636 NON-STANDARDIZED ALLERGENIC IVA XANTHIFOLIA POLLEN Burweed Marshelder INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA XANTHIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6637_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6637 NON-STANDARDIZED ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Rough Marshelder INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. IVA ANNUA VAR. ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6638_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6638 NON-STANDARDIZED ALLERGENIC PROSOPIS JULIFLORA POLLEN Mesquite INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6639_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6639 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Common Mugwort INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6640_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6640 NON-STANDARDIZED ALLERGENIC MORUS RUBRA POLLEN Red Mulberry INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6641_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6641 NON-STANDARDIZED ALLERGENIC MORUS ALBA POLLEN White Mulberry INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6642_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6642 NON-STANDARDIZED ALLERGENIC QUERCUS RUBRA POLLEN Red Oak INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6643_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6643 NON-STANDARDIZED ALLERGENIC QUERCUS VIRGINIANA POLLEN Virginia Live Oak INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6644_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6644 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN White Oak INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6646_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6646 NON-STANDARDIZED ALLERGENIC OLEA EUROPAEA POLLEN Olive Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6647_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6647 NON-STANDARDIZED ALLERGENIC SYAGRUS ROMANZOFFIANA POLLEN Queen Palm Coco Palm INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6648_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6648 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6649_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6649 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Rough Pigweed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6651_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6651 NON-STANDARDIZED ALLERGENIC PINUS STROBUS POLLEN White Pine INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS STROBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6652_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6652 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN English Plantain INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6654_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6654 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN White Poplar INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6656_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6656 NON-STANDARDIZED ALLERGENIC LIGUSTRUM VULGARE POLLEN Privet INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6657_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6657 NON-STANDARDIZED ALLERGENIC ELYMUS REPENS POLLEN Quack Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6658_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6658 NON-STANDARDIZED ALLERGENIC AMBROSIA TRIFIDA POLLEN Tall Ragweed Giant INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6659_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6659 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6670_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6670 NON-STANDARDIZED ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Common Sagebrush INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA TRIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6671_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6671 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6672_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6672 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN American Sycamore INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6674_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6674 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN Black Pollen Walnut INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6676_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6676 NON-STANDARDIZED ALLERGENIC ACACIA Acacia INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ACACIA 1000 [PNU]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6677_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6677 NON-STANDARDIZED ALLERGENIC AILANTHUS ALTISSIMA POLLEN Ailanthus Tree of Heaven INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6678_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6678 NON-STANDARDIZED ALLERGENIC ALNUS INCANA SSP RUGOSA POLLEN White Alder INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6679_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6679 NON-STANDARDIZED ALLERGENIC FRAXINUS VELUTINA POLLEN Arizona Ash INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS VELUTINA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6680_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6680 NON-STANDARDIZED ALLERGENIC FRAXINUS AMERICANA POLLEN White Ash INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6681_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6681 NON-STANDARDIZED ALLERGENIC POPULUS TREMULOIDES POLLEN Aspen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS TREMULOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6682_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6682 NON-STANDARDIZED ALLERGENIC PASPALUM NOTATUM POLLEN Bahia Grass INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. PASPALUM NOTATUM POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6683_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6683 NON-STANDARDIZED ALLERGENIC MORELLA CERIFERA POLLEN Bayberry Wax Myrtle INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. MORELLA CERIFERA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6684_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6684 NON-STANDARDIZED ALLERGENIC FAGUS GRANDIFOLIA POLLEN Beech INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. FAGUS GRANDIFOLIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6686_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6686 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN Black Birch INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6687_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6687 NON-STANDARDIZED ALLERGENIC BETULA NIGRA POLLEN River Birch Red INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA NIGRA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6688_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6688 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN White Birch INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6689_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6689 NON-STANDARDIZED ALLERGENIC POA ANNUA POLLEN Annual Bluegrass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6690_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6690 NON-STANDARDIZED ALLERGENIC ACER NEGUNDO POLLEN Box Elder Ash Leaf Maple INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6691_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6691 NON-STANDARDIZED ALLERGENIC BROMUS INERMIS POLLEN Brome Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6692_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6692 NON-STANDARDIZED ALLERGENIC BROMUS INERMIS POLLEN Brome Grass INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BROMUS INERMIS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6693_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6693 NON-STANDARDIZED ALLERGENIC AMARANTHUS PALMERI POLLEN Carelessweed INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS PALMERI POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6694_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6694 NON-STANDARDIZED ALLERGENIC JUNIPERUS ASHEI POLLEN Mountain Cedar INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS ASHEI POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6695_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6695 NON-STANDARDIZED ALLERGENIC JUNIPERUS VIRGINIANA POLLEN Red Cedar INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS VIRGINIANA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6696_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6696 NON-STANDARDIZED ALLERGENIC XANTHIUM STRUMARIUM VAR CANADENSE POLLEN Cocklebur INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6697_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6697 NON-STANDARDIZED ALLERGENIC ZEA MAYS POLLEN Corn Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6699_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6699 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES POLLEN Eastern Cottonwood Common INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6700_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6700 NON-STANDARDIZED ALLERGENIC POPULUS FREMONTII POLLEN Fremont Cottonwood INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS FREMONTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6701_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6701 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES SSP MONILIFERA POLLEN Western Cottonwood INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6702_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6702 NON-STANDARDIZED ALLERGENIC POPULUS DELTOIDES SSP MONILIFERA POLLEN Western Cottonwood INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6703_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6703 NON-STANDARDIZED ALLERGENIC CUPRESSUS ARIZONICA POLLEN Arizona Cypress INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CUPRESSUS ARIZONICA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6704_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6704 NON-STANDARDIZED ALLERGENIC RUMEX ACETOSELLA POLLEN Sour Dock Sheep Sorrel INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX ACETOSELLA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 0268-6705_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6705 NON-STANDARDIZED ALLERGENIC RUMEX CRISPUS POLLEN Yellow Dock INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. RUMEX CRISPUS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6706_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6706 NON-STANDARDIZED ALLERGENIC EUPATORIUM CAPILLIFOLIUM POLLEN Dog Fennel INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6707_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6707 NON-STANDARDIZED ALLERGENIC EUPATORIUM CAPILLIFOLIUM POLLEN Dog Fennel INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6708_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6708 NON-STANDARDIZED ALLERGENIC ULMUS AMERICANA POLLEN American Elm INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS AMERICANA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6709_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6709 NON-STANDARDIZED ALLERGENIC ULMUS CRASSIFOLIA POLLEN Cedar Elm INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS CRASSIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6710_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6710 NON-STANDARDIZED ALLERGENIC ULMUS PUMILA POLLEN Chinese Elm INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS PUMILA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6711_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6711 NON-STANDARDIZED ALLERGENIC ULMUS PUMILA POLLEN Chinese Elm INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ULMUS PUMILA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6712_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6712 NON-STANDARDIZED ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6713_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6713 NON-STANDARDIZED ALLERGENIC EUCALYPTUS GLOBULUS POLLEN Eucalyptus INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. EUCALYPTUS GLOBULUS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6714_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6714 NON-STANDARDIZED ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6715_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6715 NON-STANDARDIZED ALLERGENIC CORYLUS AMERICANA POLLEN Hazelnut Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CORYLUS AMERICANA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6716_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6716 NON-STANDARDIZED ALLERGENIC CARYA OVATA POLLEN Shagbark Hickory INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA OVATA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6717_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6717 NON-STANDARDIZED ALLERGENIC SORGHUM HALEPENSE POLLEN Johnson Grass INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. SORGHUM HALEPENSE POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6719_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6719 NON-STANDARDIZED ALLERGENIC JUNIPERUS CALIFORNICA POLLEN Western Juniper INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. JUNIPERUS CALIFORNICA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6720_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6720 NON-STANDARDIZED ALLERGENIC KOCHIA SCOPARIA POLLEN Kochia Firebush INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. KOCHIA SCOPARIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6721_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6721 NON-STANDARDIZED ALLERGENIC CHENOPODIUM ALBUM POLLEN Lambs Quarters INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM ALBUM POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6722_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6722 NON-STANDARDIZED ALLERGENIC ROBINIA PSEUDOACACIA POLLEN Black Locust INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ROBINIA PSEUDOACACIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6723_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6723 NON-STANDARDIZED ALLERGENIC ROBINIA PSEUDOACACIA POLLEN Black Locust INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ROBINIA PSEUDOACACIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6724_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6724 NON-STANDARDIZED ALLERGENIC ACER RUBRUM POLLEN Red Maple INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ACER RUBRUM POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6725_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6725 NON-STANDARDIZED ALLERGENIC ACER SACCHARUM POLLEN Sugar Maple INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ACER SACCHARUM POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6726_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6726 NON-STANDARDIZED ALLERGENIC IVA XANTHIFOLIA POLLEN Burweed Marshelder INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. IVA XANTHIFOLIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6727_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6727 NON-STANDARDIZED ALLERGENIC IVA ANNUA VAR ANNUA POLLEN Rough Marshelder INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. IVA ANNUA VAR. ANNUA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6728_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6728 NON-STANDARDIZED ALLERGENIC MELALEUCA QUINQUENERVIA POLLEN Melaleuca Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6730_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6730 NON-STANDARDIZED ALLERGENIC PROSOPIS JULIFLORA POLLEN Mesquite INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. PROSOPIS JULIFLORA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6731_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6731 NON-STANDARDIZED ALLERGENIC CHENOPODIUM AMBROSIOIDES POLLEN Mexican Tea INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6732_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6732 NON-STANDARDIZED ALLERGENIC ARTEMISIA VULGARIS POLLEN Common Mugwort INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA VULGARIS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6734_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6734 NON-STANDARDIZED ALLERGENIC MORUS RUBRA POLLEN Red Mulberry INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS RUBRA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6735_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6735 NON-STANDARDIZED ALLERGENIC MORUS ALBA POLLEN White Mulberry INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. MORUS ALBA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6736_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6736 NON-STANDARDIZED ALLERGENIC QUERCUS AGRIFOLIA POLLEN California Live Oak Coast INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6737_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6737 NON-STANDARDIZED ALLERGENIC QUERCUS AGRIFOLIA POLLEN California Live Oak Coast INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS AGRIFOLIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6738_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6738 NON-STANDARDIZED ALLERGENIC QUERCUS RUBRA POLLEN Red Oak INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS RUBRA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6739_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6739 NON-STANDARDIZED ALLERGENIC QUERCUS VIRGINIANA POLLEN Virginia Live Oak INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS VIRGINIANA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6740_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6740 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN White Oak INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6741_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6741 NON-STANDARDIZED ALLERGENIC QUERCUS ALBA POLLEN Wild Pollen Oat INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6743_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6743 NON-STANDARDIZED ALLERGENIC SCHINUS MOLLE POLLEN California Pepper Tree INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6744_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6744 NON-STANDARDIZED ALLERGENIC AMARANTHUS SPINOSUS POLLEN Spiny Pigweed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS SPINOSUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6745_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6745 NON-STANDARDIZED ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Australian Pine Beefwood INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CASUARINA EQUISETIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6748_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6748 NON-STANDARDIZED ALLERGENIC PINUS ECHINATA POLLEN Yellow Pine INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PINUS ECHINATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6749_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6749 NON-STANDARDIZED ALLERGENIC AMBROSIA ACANTHICARPA POLLEN False Ragweed Bur INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ACANTHICARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6750_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6750 NON-STANDARDIZED ALLERGENIC AMBROSIA TENUIFOLIA POLLEN Slender Ragweed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TENUIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6751_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6751 NON-STANDARDIZED ALLERGENIC AMBROSIA BIDENTATA POLLEN Southern Ragweed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA BIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6752_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6752 NON-STANDARDIZED ALLERGENIC AMBROSIA PSILOSTACHYA POLLEN Western Ragweed INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6754_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6754 NON-STANDARDIZED ALLERGENIC LOLIUM PERENNE SSP MULTIFLORUM POLLEN Italian Rye Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6755_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6755 NON-STANDARDIZED ALLERGENIC ARTEMISIA FRIGIDA POLLEN Prairie Sage INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA FRIGIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6757_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6757 NON-STANDARDIZED ALLERGENIC DISTICHLIS SPICATA POLLEN Salt Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6760_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6760 NON-STANDARDIZED ALLERGENIC HOLCUS LANATUS POLLEN Velvet Grass INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. HOLCUS LANATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6761_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6761 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN California Walnut Black Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6762_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6762 NON-STANDARDIZED ALLERGENIC JUGLANS REGIA POLLEN English Walnut Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS REGIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6763_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6763 NON-STANDARDIZED ALLERGENIC TRITICUM AESTIVUM POLLEN Wheat Pollen INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. TRITICUM AESTIVUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6764_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6764 NON-STANDARDIZED ALLERGENIC ARTEMISIA ANNUA POLLEN Common Wormwood Annual INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6771_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6771 NON-STANDARDIZED ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp INJECTION, SOLUTION PERCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS TUBERCULATUS POLLEN .025 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6772_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6772 NON-STANDARDIZED ALLERGENIC BETULA LENTA POLLEN White Pine INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. BETULA LENTA POLLEN .002 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6773_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6773 NON-STANDARDIZED ALLERGENIC OLEA EUROPAEA POLLEN Olive Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. OLEA EUROPAEA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6774_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6774 NON-STANDARDIZED ALLERGENIC SYAGRUS ROMANZOFFIANA POLLEN Queen Palm Coco Palm INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. SYAGRUS ROMANZOFFIANA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6775_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6775 NON-STANDARDIZED ALLERGENIC CARYA ILLINOINENSIS POLLEN Pecan Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA ILLINOINENSIS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6776_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6776 NON-STANDARDIZED ALLERGENIC AMARANTHUS RETROFLEXUS POLLEN Rough Pigweed Redroot INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS RETROFLEXUS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6777_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6777 NON-STANDARDIZED ALLERGENIC CASUARINA EQUISETIFOLIA POLLEN Australian Pine Beefwood INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. CASUARINA EQUISETIFOLIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6778_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6778 NON-STANDARDIZED ALLERGENIC PLANTAGO LANCEOLATA POLLEN English Plantain INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. PLANTAGO LANCEOLATA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6779_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6779 NON-STANDARDIZED ALLERGENIC POPULUS ALBA POLLEN White Poplar INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. POPULUS ALBA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6780_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6780 NON-STANDARDIZED ALLERGENIC LIGUSTRUM VULGARE POLLEN Privet INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. LIGUSTRUM VULGARE POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6781_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6781 NON-STANDARDIZED ALLERGENIC AMBROSIA ACANTHICARPA POLLEN False Ragweed Bur INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ACANTHICARPA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6782_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6782 NON-STANDARDIZED ALLERGENIC AMBROSIA TRIFIDA POLLEN Tall Ragweed Giant INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA TRIFIDA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6783_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6783 NON-STANDARDIZED ALLERGENIC AMBROSIA PSILOSTACHYA POLLEN Western Ragweed INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA PSILOSTACHYA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6784_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6784 NON-STANDARDIZED ALLERGENIC SALSOLA KALI POLLEN Russian Thistle INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. SALSOLA KALI POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6785_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6785 NON-STANDARDIZED ALLERGENIC ARTEMISIA FRIGIDA POLLEN Prairie Sage INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA FRIGIDA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6786_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6786 NON-STANDARDIZED ALLERGENIC ARTEMISIA TRIDENTATA POLLEN Common Sagebrush INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. ARTEMISIA TRIDENTATA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6787_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6787 NON-STANDARDIZED ALLERGENIC LIQUIDAMBAR STYRACIFLUA POLLEN Sweetgum Non Stock INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6788_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6788 NON-STANDARDIZED ALLERGENIC PLATANUS OCCIDENTALIS POLLEN American Sycamore INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. PLATANUS OCCIDENTALIS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6790_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6790 NON-STANDARDIZED ALLERGENIC HOLCUS LANATUS POLLEN Velvet Grass INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. HOLCUS LANATUS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6791_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6791 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN Walnut Black Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6792_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6792 NON-STANDARDIZED ALLERGENIC JUGLANS NIGRA POLLEN California Walnut Black Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS NIGRA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6793_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6793 NON-STANDARDIZED ALLERGENIC JUGLANS REGIA POLLEN English Walnut Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. JUGLANS REGIA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6794_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6794 NON-STANDARDIZED ALLERGENIC AMARANTHUS TUBERCULATUS POLLEN Water Hemp INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. AMARANTHUS TUBERCULATUS POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6795_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6795 NON-STANDARDIZED ALLERGENIC TRITICUM AESTIVUM POLLEN Wheat Pollen INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. TRITICUM AESTIVUM POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-6796_bb0f261e-93dd-41c4-90f8-95a5f603d8c3 0268-6796 NON-STANDARDIZED ALLERGENIC SALIX NIGRA POLLEN Black Willow INJECTION, SOLUTION INTRADERMAL 19650101 BLA BLA103753 ALK-Abello, Inc. SALIX NIGRA POLLEN 1000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-7000_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-7000 HUMAN PRESCRIPTION DRUG Standardized Mite D. farinae Standardized Mite D. farinae SOLUTION PERCUTANEOUS 19910708 BLA BLA103060 ALK-Abello, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-7001_0fbc190d-80b9-4c94-b8dc-637ae1c75366 0268-7001 HUMAN PRESCRIPTION DRUG Standardized Mite D. pteronyssinus Standardized Mite D. pteronyssinus SOLUTION PERCUTANEOUS 19900814 BLA BLA103752 ALK-Abello, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-7002_e898c242-9437-4ca6-881a-6a55d4aba392 0268-7002 STANDARDIZED ALLERGENIC Standardized Mite, Mixed Standardized Mite, Mixed INJECTION, SOLUTION SUBCUTANEOUS 19910708 BLA BLA103060 ALK-Abello, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 10000; 10000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-7003_e898c242-9437-4ca6-881a-6a55d4aba392 0268-7003 STANDARDIZED ALLERGENIC Standardized Mite, Mixed Standardized Mite, Mixed INJECTION, SOLUTION SUBCUTANEOUS 19910708 BLA BLA103060 ALK-Abello, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 5000; 5000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8000_d9e9fa3c-d7f0-4b08-9b7d-ba10e025eaca 0268-8000 NON-STANDARDIZED ALLERGENIC 10 TREE MIX ACER NEGUNDO POLLEN, BETULA NIGRA POLLEN, BLACK WALNUT, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN, QUERCUS RUBRA POLLEN, SALIX NIGRA BARK and ULMUS CRASSIFOLIA POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. FRAXINUS AMERICANA POLLEN; BETULA NIGRA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; ULMUS CRASSIFOLIA POLLEN; CARYA OVATA POLLEN; QUERCUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; BLACK WALNUT; SALIX NIGRA BARK .05; .05; .05; .05; .05; .05; .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 0268-8001_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8001 NON-STANDARDIZED ALLERGENIC 3 GRASS MIX BROMUS INERMIS POLLEN, CYNODON DACTYLON, CYNODON DACTYLON INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CYNODON DACTYLON; BROMUS INERMIS POLLEN; SORGHUM HALEPENSE POLLEN 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8002_d9e9fa3c-d7f0-4b08-9b7d-ba10e025eaca 0268-8002 NON-STANDARDIZED ALLERGENIC 4 WEED MIX AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8003_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8003 NON-STANDARDIZED ALLERGENIC 4 WEED MIX AMARANTHUS RETROFLEXUS POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN 40000; 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8004_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8004 NON-STANDARDIZED ALLERGENIC 4 WEED MIX AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8005_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8005 NON-STANDARDIZED ALLERGENIC 5 GRASS MIX PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN 1000; 1000; 1000; 1000; 1000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8006_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8006 NON-STANDARDIZED ALLERGENIC 5 GRASS MIX PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN 5000; 5000; 5000; 5000; 5000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8007_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8007 NON-STANDARDIZED ALLERGENIC 5 GRASS MIX PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN 10000; 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8008_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8008 NON-STANDARDIZED ALLERGENIC 5 GRASS MIX AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, DACTYLIS GLOMERATA, PHLEUM PRATENSE, POA PRATENSIS INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM 10000; 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8009_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8009 NON-STANDARDIZED ALLERGENIC 5 GRASS MIX AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, DACTYLIS GLOMERATA, PHLEUM PRATENSE, POA PRATENSIS INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8010_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8010 NON-STANDARDIZED ALLERGENIC 5 GRASS MIX PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN 100; 100; 100; 100; 100 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8011_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8011 NON-STANDARDIZED ALLERGENIC 6 GRASS MIX AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS; LOLIUM PERENNE 10000; 10000; 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8012_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8012 NON-STANDARDIZED ALLERGENIC 6 GRASS MIX AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS; LOLIUM PERENNE 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8013_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8013 NON-STANDARDIZED ALLERGENIC 7 GRASS MIX AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS; LOLIUM PERENNE; ANTHOXANTHUM ODORATUM 10000; 10000; 10000; 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8014_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8014 NON-STANDARDIZED ALLERGENIC 7 GRASS MIX AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS; LOLIUM PERENNE; ANTHOXANTHUM ODORATUM 20000; 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8015_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8015 NON-STANDARDIZED ALLERGENIC 8 SOUTHERN GRASS MIX AGROSTIS GIGANTEA POLLEN, CYNODON DACTYLON, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS, SORGHUM HALEPENSE POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CYNODON DACTYLON; SORGHUM HALEPENSE POLLEN; PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS; LOLIUM PERENNE 10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8016_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8016 NON-STANDARDIZED ALLERGENIC 8 SOUTHERN GRASS MIX AGROSTIS GIGANTEA POLLEN, CYNODON DACTYLON, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS, SORGHUM HALEPENSE POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CYNODON DACTYLON; SORGHUM HALEPENSE POLLEN; PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS; LOLIUM PERENNE 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8017_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8017 NON-STANDARDIZED ALLERGENIC 9 SOUTHERN GRASS MIX AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, CYNODON DACTYLON, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS, SORGHUM HALEPENSE POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. CYNODON DACTYLON; SORGHUM HALEPENSE POLLEN; PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS; LOLIUM PERENNE; ANTHOXANTHUM ODORATUM 10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8020_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8020 NON-STANDARDIZED ALLERGENIC 9 TREE MIX ACER SACCHARINUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA WHOLE, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN, ULMUS CRASSIFOLIA POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALNUS RHOMBIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; BETULA LENTA WHOLE; ACER SACCHARINUM POLLEN; CARYA OVATA POLLEN; QUERCUS ALBA POLLEN; POPULUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN 40000; 40000; 40000; 40000; 40000; 40000; 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8021_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8021 NON-STANDARDIZED ALLERGENIC 9 TREE MIX ACER SACCHARINUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA WHOLE, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN, ULMUS CRASSIFOLIA POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALNUS RHOMBIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; BETULA LENTA WHOLE; ACER SACCHARINUM POLLEN; CARYA OVATA POLLEN; QUERCUS ALBA POLLEN; POPULUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN .1; .1; .1; .1; .1; .1; .1; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8022_bdbd5a26-7d68-4b38-b50d-19cb2d40e29a 0268-8022 NON-STANDARDIZED ALLERGENIC 9 TREE MIX ACER SACCHARUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA POLLEN, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN and ULMUS CRASSIFOLIA POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ALNUS RHOMBIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; BETULA LENTA POLLEN; ACER SACCHARUM POLLEN; CARYA OVATA POLLEN; QUERCUS ALBA POLLEN; POPULUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN .05; .05; .05; .05; .05; .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8023_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8023 NON-STANDARDIZED ALLERGENIC 9 TREE MIX ACER SACCHARUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA POLLEN, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN, ULMUS CRASSIFOLIA POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. ALNUS RHOMBIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; BETULA LENTA POLLEN; ACER SACCHARUM POLLEN; CARYA OVATA POLLEN; QUERCUS ALBA POLLEN; POPULUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN 10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8024_d9e9fa3c-d7f0-4b08-9b7d-ba10e025eaca 0268-8024 NON-STANDARDIZED ALLERGENIC BIRCH MIX BETULA NIGRA, BETULA POPULIFOLIA INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. BETULA POPULIFOLIA POLLEN; BETULA NIGRA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8025_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8025 NON-STANDARDIZED ALLERGENIC FAPP MIXTURE ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, GIBBERELLA ZEAE, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PHOMA EXIGUA VAR. EXIGUA INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GIBBERELLA ZEAE; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA EXIGUA VAR. EXIGUA 20000; 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8026_b9ce27d0-6761-45a8-8ae4-4a4ac541e8fe 0268-8026 STANDARDIZED ALLERGENIC GRASS MIX 4-S AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN INJECTION, SOLUTION PERCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN 25000; 25000; 25000; 25000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8027_739d8b33-ea2e-412a-b27e-b23d1ac3415f 0268-8027 STANDARDIZED ALLERGENIC GRASS MIX Number 4-S AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103052 ALK-Abello, Inc. POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 25000; 25000; 25000; 25000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8029_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8029 NON-STANDARDIZED ALLERGENIC HICKORY PECAN MIX CARYA ILLINOINENSIS POLLEN, CARYA OVATA POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. CARYA OVATA POLLEN; CARYA ILLINOINENSIS POLLEN .1; .1 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8030_bdbd5a26-7d68-4b38-b50d-19cb2d40e29a 0268-8030 NON-STANDARDIZED ALLERGENIC HICKORY PECAN MIX CARYA ILLINOINENSIS POLLEN and CARYA OVATA POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CARYA OVATA POLLEN; CARYA ILLINOINENSIS POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8033_bdbd5a26-7d68-4b38-b50d-19cb2d40e29a 0268-8033 NON-STANDARDIZED ALLERGENIC MAPLE MIX ACER NEGUNDO POLLEN and ACER RUBRUM POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8034_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8034 NON-STANDARDIZED ALLERGENIC MIXED ASPERGILLUS ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8035_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8035 NON-STANDARDIZED ALLERGENIC MIXED ASPERGILLUS ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS 40000; 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8036_d9e9fa3c-d7f0-4b08-9b7d-ba10e025eaca 0268-8036 NON-STANDARDIZED ALLERGENIC MIXED ASPERGILLUS ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8037_d9e9fa3c-d7f0-4b08-9b7d-ba10e025eaca 0268-8037 NON-STANDARDIZED ALLERGENIC MIXED ASPERGILLUS ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8039_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8039 NON-STANDARDIZED ALLERGENIC MIDWEST MOLDS CHAETOMIUM GLOBOSUM, COCHLIOBOLUS SATIVUS, GIBBERELLA ZEAE, MUCOR PLUMBEUS, PHOMA EXIGUA VAR. EXIGUA, RHIZOPUS ARRHIZUS VAR. ARRHIZUS INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. COCHLIOBOLUS SATIVUS; CHAETOMIUM GLOBOSUM; GIBBERELLA ZEAE; MUCOR PLUMBEUS; PHOMA EXIGUA VAR. EXIGUA; RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8041_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8041 NON-STANDARDIZED ALLERGENIC MIXED FEATHERS ANAS PLATYRHYNCHOS FEATHER, ANSER ANSER FEATHER, GALLUS GALLUS FEATHER INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] N 20181231 0268-8042_d9e9fa3c-d7f0-4b08-9b7d-ba10e025eaca 0268-8042 NON-STANDARDIZED ALLERGENIC MIXED FEATHERS GALLUS GALLUS FEATHER, ANAS PLATYRHYNCHOS FEATHER, ANSER ANSER FEATHER INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] N 20181231 0268-8045_8a6ef994-deb3-428e-8792-79ac0515885c 0268-8045 NON-STANDARDIZED ALLERGENIC MIXED MOLDS ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM and PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA; CLADOSPORIUM SPHAEROSPERMUM; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1; .1; .1; .1; .1; .1; .2 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8046_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8046 NON-STANDARDIZED ALLERGENIC MIXED MOLDS ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA; CLADOSPORIUM SPHAEROSPERMUM; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000; 10000; 10000; 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8047_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8047 NON-STANDARDIZED ALLERGENIC MIXED MOLDS ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA; CLADOSPORIUM SPHAEROSPERMUM; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000; 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8048_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8048 NON-STANDARDIZED ALLERGENIC MIXED MOLDS ALTERNARIA ALTERNATA, ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, CLADOSPORIUM SPHAEROSPERMUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA; CLADOSPORIUM SPHAEROSPERMUM; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000; 40000; 40000; 40000; 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8049_d9e9fa3c-d7f0-4b08-9b7d-ba10e025eaca 0268-8049 NON-STANDARDIZED ALLERGENIC MIXED MOLDS ALTERNARIA ALTERNATA, CLADOSPORIUM SPHAEROSPERMUM, ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS, PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA; CLADOSPORIUM SPHAEROSPERMUM; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000; 10000; 10000; 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8050_d9e9fa3c-d7f0-4b08-9b7d-ba10e025eaca 0268-8050 NON-STANDARDIZED ALLERGENIC MIXED MOLDS ALTERNARIA ALTERNATA, CLADOSPORIUM SPHAEROSPERMUM, ASPERGILLUS NIGER, ASPERGILLUS REPENS, ASPERGILLUS ORYZAE, ASPERGILLUS TERREUS, PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA; CLADOSPORIUM SPHAEROSPERMUM; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; ASPERGILLUS FLAVUS VAR. ORYZAE; ASPERGILLUS TERREUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000; 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8051_8a6ef994-deb3-428e-8792-79ac0515885c 0268-8051 NON-STANDARDIZED ALLERGENIC MIXED PENICILLIUM PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .2 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8052_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8052 NON-STANDARDIZED ALLERGENIC MIXED PENICILLIUM PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8053_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8053 NON-STANDARDIZED ALLERGENIC MIXED PENICILLIUM PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8054_d9e9fa3c-d7f0-4b08-9b7d-ba10e025eaca 0268-8054 NON-STANDARDIZED ALLERGENIC MIXED PENICILLIUM PENICILLIUM CHRYSOGENUM, PENICILLIUM NOTATUM INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8056_8a6ef994-deb3-428e-8792-79ac0515885c 0268-8056 NON-STANDARDIZED ALLERGENIC MIXED RAGWEED AMBROSIA ARTEMISIIFOLIA and AMBROSIA TRIFIDA POLLEN INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA; AMBROSIA TRIFIDA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8057_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8057 NON-STANDARDIZED ALLERGENIC MIXED RAGWEED AMBROSIA ARTEMISIIFOLIA, AMBROSIA TRIFIDA POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA; AMBROSIA TRIFIDA POLLEN 10000; 10000 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8058_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8058 NON-STANDARDIZED ALLERGENIC MIXED RAGWEED AMBROSIA ARTEMISIIFOLIA, AMBROSIA TRIFIDA POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA; AMBROSIA TRIFIDA POLLEN 20000; 20000 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8059_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8059 NON-STANDARDIZED ALLERGENIC MIXED RAGWEED AMBROSIA ARTEMISIIFOLIA, AMBROSIA TRIFIDA POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA; AMBROSIA TRIFIDA POLLEN 40000; 40000 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8060_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8060 NON-STANDARDIZED ALLERGENIC MIXED RAGWEED AMBROSIA ARTEMISIIFOLIA, AMBROSIA TRIFIDA POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AMBROSIA ARTEMISIIFOLIA; AMBROSIA TRIFIDA POLLEN .1; .1 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8061_8a6ef994-deb3-428e-8792-79ac0515885c 0268-8061 NON-STANDARDIZED ALLERGENIC MIXED SHELLFISH CRAB LEG, UNSPECIFIED, LOBSTER, UNSPECIFIED, OYSTER, UNSPECIFIED and SHRIMP, UNSPECIFIED INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CRAB LEG, UNSPECIFIED; SHRIMP, UNSPECIFIED; LOBSTER, UNSPECIFIED; OYSTER, UNSPECIFIED .1; .1; .1; .1 g/mL; g/mL; g/mL; g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 0268-8062_bdbd5a26-7d68-4b38-b50d-19cb2d40e29a 0268-8062 NON-STANDARDIZED ALLERGENIC MIXED SHELLFISH PARALITHODES CAMTSCHATICA, CRANGON CRANGON, HOMARUS AMERICANUS, CRASSOSTREA VIRGINICA INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. CRAB LEG, UNSPECIFIED; SHRIMP, UNSPECIFIED; LOBSTER, UNSPECIFIED; OYSTER, UNSPECIFIED .1; .1; .1; .1 g/mL; g/mL; g/mL; g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 0268-8063_bdbd5a26-7d68-4b38-b50d-19cb2d40e29a 0268-8063 NON-STANDARDIZED ALLERGENIC MIXED WEEDS CHENOPODIUM ALBUM POLLEN, IVA ANNUA POLLEN, LANCEOLATA POLLEN and XANTHIUM STRUMARIUM POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA POLLEN .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8064_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8064 NON-STANDARDIZED ALLERGENIC MOLD MIX 1 ALTERNARIA ALTERNATA, ALTERNARIA ALTERNATA, CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM SPHAEROSPERMUM 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8065_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8065 NON-STANDARDIZED ALLERGENIC MOLD MIX 1 ALTERNARIA ALTERNATA, ASPERGILLUS NIGER, CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM SPHAEROSPERMUM 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8066_bdbd5a26-7d68-4b38-b50d-19cb2d40e29a 0268-8066 NON-STANDARDIZED ALLERGENIC MOLD MIX Number 1 ALTERNARIA ALTERNATA, ASPERGILLUS NIGER VAR. NIGER and CLADOSPORIUM SPHAEROSPERMUM INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM SPHAEROSPERMUM 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8067_8a6ef994-deb3-428e-8792-79ac0515885c 0268-8067 NON-STANDARDIZED ALLERGENIC MOLD MIX 2 AUREOBASIDIUM PULLULANS VAR. PULLUTANS, CURVULARIA INAEQUALIS, GIBBERELLA ZEAE, MUCOR PLUMBEUS and RHIZOPUS ARRHIZUS INJECTION, SOLUTION PERCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CURVULARIA INAEQUALIS; GIBBERELLA ZEAE; MUCOR PLUMBEUS; RHIZOPUS ARRHIZUS VAR. ARRHIZUS .1; .1; .1; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8068_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8068 NON-STANDARDIZED ALLERGENIC MOLD MIX 2 AUREOBASIDIUM PULLULANS, CURVULARIA INAEQUALIS, FUSARIUM ROSEUM, MUCOR PLUMBEUS, PHIZOPUS ORYZAE INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CURVULARIA INAEQUALIS; GIBBERELLA ZEAE; MUCOR PLUMBEUS; RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8069_7529b058-1dc4-4079-936c-5bd2e137a263 0268-8069 NON-STANDARDIZED ALLERGENIC MOLD MIX 2 AUREOBASIDIUM PULLULANS, CURVULARIA INAEQUALIS, FUSARIUM ROSEUM, MUCOR PLUMBEUS, PHIZOPUS ORYZAE INJECTION, SOLUTION SUBCUTANEOUS 19650101 BLA BLA103753 ALK-Abello, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CURVULARIA INAEQUALIS; GIBBERELLA ZEAE; MUCOR PLUMBEUS; RHIZOPUS ARRHIZUS VAR. ARRHIZUS 40000; 40000; 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8070_bdbd5a26-7d68-4b38-b50d-19cb2d40e29a 0268-8070 NON-STANDARDIZED ALLERGENIC OAK MIX QUERCUS RUBRA, QUERCUS ALBA, QUERCUS VIRGINIANA INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; QUERCUS VIRGINIANA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8073_739d8b33-ea2e-412a-b27e-b23d1ac3415f 0268-8073 STANDARDIZED ALLERGENIC MIX OF 5 STANDARD GRASS POLLEN AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN 20000; 20000; 20000; 20000; 20000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8073_b9ce27d0-6761-45a8-8ae4-4a4ac541e8fe 0268-8073 STANDARDIZED ALLERGENIC MIX OF 5 STANDARD GRASS POLLEN AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN INJECTION, SOLUTION PERCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN 20000; 20000; 20000; 20000; 20000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8074_739d8b33-ea2e-412a-b27e-b23d1ac3415f 0268-8074 STANDARDIZED ALLERGENIC MIX OF 6 STANDARD GRASS POLLEN AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN 16667; 16667; 16667; 16667; 16667; 16667 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8074_b9ce27d0-6761-45a8-8ae4-4a4ac541e8fe 0268-8074 STANDARDIZED ALLERGENIC MIX OF 6 STANDARD GRASS POLLEN AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN INJECTION, SOLUTION PERCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN 16667; 16667; 16667; 16667; 16667; 16667 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8076_739d8b33-ea2e-412a-b27e-b23d1ac3415f 0268-8076 STANDARDIZED ALLERGENIC MIX OF 7 STANDARD GRASS POLLEN AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, POA PRATENSIS POLLEN and ANTHOXANTHUM ODORATUM POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; ANTHOXANTHUM ODORATUM POLLEN 14286; 14286; 14286; 14286; 14286; 14286; 14286 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8076_b9ce27d0-6761-45a8-8ae4-4a4ac541e8fe 0268-8076 STANDARDIZED ALLERGENIC MIX OF 7 STANDARD GRASS POLLEN AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN INJECTION, SOLUTION PERCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; ANTHOXANTHUM ODORATUM POLLEN 14286; 14286; 14286; 14286; 14286; 14286; 14286 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8077_739d8b33-ea2e-412a-b27e-b23d1ac3415f 0268-8077 STANDARDIZED ALLERGENIC MIDWEST MIX OF STANDARD GRASS AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19971218 BLA BLA103058 ALK-Abello, Inc. PHLEUM PRATENSE POLLEN; DACTYLIS GLOMERATA POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN 40000; 20000; 20000; 20000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8078_bdbd5a26-7d68-4b38-b50d-19cb2d40e29a 0268-8078 NON-STANDARDIZED ALLERGENIC WEED MIX Number 7B AMARANTHUS RETROFLEXUS POLLEN, ARTEMISIA VULGARIS ROOT, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, RUMEX ACETOSELLA POLLEN, RUMEX CRISPUS POLLEN and STRUMARIUM POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19980223 BLA BLA103753 ALK-Abello, Inc. XANTHIUM STRUMARIUM POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; ARTEMISIA VULGARIS ROOT; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN .05; .05; .05; .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8079_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d 0268-8079 NON-STANDARDIZED ALLERGENIC WESTERN WEED MIX AMBROSIA ACANTHICARPA POLLEN, AMBROSIA PSILOSTACHYA POLLEN, ARTEMISIA TRIDENTATA POLLEN, BASSIA SCOPARIA POLLEN, SALSOLA KALI POLLEN INJECTION, SOLUTION SUBCUTANEOUS 19750115 BLA BLA103753 ALK-Abello, Inc. BASSIA SCOPARIA POLLEN; ARTEMISIA TRIDENTATA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA ACANTHICARPA POLLEN; SALSOLA KALI POLLEN 10000; 10000; 10000; 10000; 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0268-8116_03615445-db78-47fe-b504-75af3efc5dcf 0268-8116 STANDARDIZED ALLERGENIC STANDARDIZED MITE, MIXED DERMATOPHAGOIDES FARINAE and DERMATOPHAGOIDES PTERONYSSINUS INJECTION, SOLUTION PERCUTANEOUS 19910708 BLA BLA103060 ALK-Abello, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 5000; 5000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 0270-0083_12f4df45-879f-36f4-ded6-16857c1f20b9 0270-0083 HUMAN PRESCRIPTION DRUG Choletec Mebrofenin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19870121 NDA NDA018963 Bracco Diagnostics Inc MEBROFENIN 45 mg/1 N 20181231 0270-0091_b51739a7-f4a7-4c3f-af96-6b75d661bf41 0270-0091 HUMAN PRESCRIPTION DRUG CardioGen-82 Rubidium Chloride RB-82 INJECTION, SOLUTION INTRAVENOUS 19891230 NDA NDA019414 Bracco Diagnostics Inc RUBIDIUM CHLORIDE RB-82 150 mCi/1 Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 0270-0149_69967fe9-08bc-7365-6b64-0dd33824b69d 0270-0149 HUMAN PRESCRIPTION DRUG Cystografin diatrizoate meglumine INJECTION, SOLUTION INTRAVENOUS 19701103 NDA NDA010040 BRACCO DIAGNOSTICS INC DIATRIZOATE MEGLUMINE 300 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-0445_c0afca1c-73d2-1224-0684-682ca346e7bb 0270-0445 HUMAN PRESCRIPTION DRUG Gastrografin diatrizoate meglumine and diatrizoate sodium LIQUID ORAL; RECTAL 19580226 NDA NDA011245 Bracco Diagnostics Inc DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 660; 100 mg/mL; mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-0556_06ea4a2d-d16a-a4a4-1c23-ba89338bc304 0270-0556 HUMAN PRESCRIPTION DRUG KINEVAC sincalide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19760721 NDA NDA017697 Bracco Diagnostics Inc. SINCALIDE 5 ug/5mL Cholecystokinin [Chemical/Ingredient],Cholecystokinin Analog [EPC] N 20191231 0270-1111_327359a5-d0f5-7ee8-2375-e54497131b4d 0270-1111 HUMAN PRESCRIPTION DRUG ProHance gadoteridol INJECTION, SOLUTION INTRAVENOUS 20031009 NDA NDA021489 Bracco Diagnostics Inc GADOTERIDOL 279.3 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20191231 0270-1111_ad45babd-55fc-1f60-cdad-3d0720d36042 0270-1111 HUMAN PRESCRIPTION DRUG ProHance gadoteridol INJECTION, SOLUTION INTRAVENOUS 19921116 NDA NDA020131 BRACCO DIAGNOSTICS INC GADOTERIDOL 279.3 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20191231 0270-1314_02866087-c9e7-1969-75d3-913210d99754 0270-1314 HUMAN PRESCRIPTION DRUG ISOVUE 200 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19851231 NDA NDA018735 BRACCO DIAGNOSTICS INC IOPAMIDOL 408 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-1315_02866087-c9e7-1969-75d3-913210d99754 0270-1315 HUMAN PRESCRIPTION DRUG ISOVUE 300 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19851231 NDA NDA018735 BRACCO DIAGNOSTICS INC IOPAMIDOL 612 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-1315_0b6e1d98-6d56-aef9-1519-38705ba4bd6e 0270-1315 HUMAN PRESCRIPTION DRUG ISOVUE 300 IOPAMIDOL INJECTION, SOLUTION INTRAVENOUS 20140620 NDA NDA020327 Bracco Diagnostics Inc IOPAMIDOL 612 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-1315_daec3eb0-9d84-a7b2-984e-be0c7410108b 0270-1315 HUMAN PRESCRIPTION DRUG ISOVUE 300 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19941012 NDA NDA020327 Bracco Diagnostics Inc IOPAMIDOL 612 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-1316_02866087-c9e7-1969-75d3-913210d99754 0270-1316 HUMAN PRESCRIPTION DRUG ISOVUE 370 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19851231 NDA NDA018735 BRACCO DIAGNOSTICS INC IOPAMIDOL 755 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-1316_0b6e1d98-6d56-aef9-1519-38705ba4bd6e 0270-1316 HUMAN PRESCRIPTION DRUG ISOVUE 370 IOPAMIDOL INJECTION, SOLUTION INTRAVENOUS 20140620 NDA NDA020327 Bracco Diagnostics Inc IOPAMIDOL 755 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-1316_daec3eb0-9d84-a7b2-984e-be0c7410108b 0270-1316 HUMAN PRESCRIPTION DRUG ISOVUE 370 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19941012 NDA NDA020327 Bracco Diagnostics Inc IOPAMIDOL 755 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-1317_02866087-c9e7-1969-75d3-913210d99754 0270-1317 HUMAN PRESCRIPTION DRUG ISOVUE 250 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19851231 NDA NDA018735 BRACCO DIAGNOSTICS INC IOPAMIDOL 510 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-1317_daec3eb0-9d84-a7b2-984e-be0c7410108b 0270-1317 HUMAN PRESCRIPTION DRUG ISOVUE 250 IOPAMIDOL INJECTION, SOLUTION INTRAVASCULAR 19941012 NDA NDA020327 Bracco Diagnostics Inc IOPAMIDOL 510 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-1410_5ba4370a-934e-bc6c-4f52-de29adab9005 0270-1410 HUMAN PRESCRIPTION DRUG Cystografin Dilute diatrizoate meglumine INJECTION, SOLUTION INTRAVESICAL 19821109 NDA NDA010040 BRACCO DIAGNOSTICS INC DIATRIZOATE MEGLUMINE 180 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-1411_de9255a0-c906-c0b4-c730-3eca51789215 0270-1411 HUMAN PRESCRIPTION DRUG ISOVUE-M IOPAMIDOL INJECTION, SOLUTION INTRATHECAL 19851231 NDA NDA018735 Bracco Diagnostics Inc IOPAMIDOL 408 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-1412_de9255a0-c906-c0b4-c730-3eca51789215 0270-1412 HUMAN PRESCRIPTION DRUG ISOVUE-M IOPAMIDOL INJECTION, SOLUTION INTRATHECAL 19851231 NDA NDA018735 Bracco Diagnostics Inc IOPAMIDOL 612 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0270-5164_55573e26-b126-974b-2bd2-0bce5ac22782 0270-5164 HUMAN PRESCRIPTION DRUG MultiHance gadobenate dimeglumine INJECTION, SOLUTION INTRAVENOUS 20041123 NDA NDA021357 BRACCO DIAGNOSTICS INC GADOBENATE DIMEGLUMINE 529 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] N 20191231 0270-5264_e5f27885-643b-6918-349e-719aa3f492a2 0270-5264 HUMAN PRESCRIPTION DRUG MultiHance gadobenate dimeglumine INJECTION, SOLUTION INTRAVENOUS 20041123 NDA NDA021358 BRACCO DIAGNOSTICS INC GADOBENATE DIMEGLUMINE 529 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] N 20191231 0270-7099_fc06c2c9-e654-2ad6-4398-713e161e9ae5 0270-7099 HUMAN PRESCRIPTION DRUG LumaSon SULFUR HEXAFLUORIDE KIT 20150115 NDA NDA203684 BRACCO DIAGNOSTICS INC N 20181231 0273-0104_dc83eefb-4783-48e5-97b2-89bd702b80ce 0273-0104 HUMAN OTC DRUG Ammonia Inhalants Ammonia Inhalants INHALANT RESPIRATORY (INHALATION) 20180109 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC AMMONIA .045 g/.3mL N 20191231 0273-0241_24ea2315-a2fa-4d72-9b41-87d3663b7799 0273-0241 HUMAN PRESCRIPTION DRUG Oral B NeutraCare Mint Menthe Sodium Fluoride SOLUTION ORAL 20141123 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC SODIUM FLUORIDE .5 mg/g N 20181231 0273-0341_b37bdd3a-d452-450c-be5d-9a1fdbbdd545 0273-0341 HUMAN PRESCRIPTION DRUG Oral B Minute-Foam Mellow Mint Sodium Fluoride SOLUTION ORAL 20141123 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC SODIUM FLUORIDE 12.3 mg/g N 20191231 0273-0342_b37bdd3a-d452-450c-be5d-9a1fdbbdd545 0273-0342 HUMAN PRESCRIPTION DRUG Oral B Minute-Foam Orange-A-Tangy Sodium Fluoride SOLUTION ORAL 20141123 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC SODIUM FLUORIDE 12.3 mg/g N 20191231 0273-0345_b37bdd3a-d452-450c-be5d-9a1fdbbdd545 0273-0345 HUMAN PRESCRIPTION DRUG Oral B Minute-Foam Bubble Gum Sodium Fluoride SOLUTION ORAL 20141123 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC SODIUM FLUORIDE 12.3 mg/g N 20191231 0273-0346_b37bdd3a-d452-450c-be5d-9a1fdbbdd545 0273-0346 HUMAN PRESCRIPTION DRUG Oral B Minute-Foam Strawberry Sodium Fluoride SOLUTION ORAL 20141123 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC SODIUM FLUORIDE 12.3 mg/g N 20191231 0273-0348_e3a66347-54a3-4627-883f-0d2b23484c56 0273-0348 HUMAN PRESCRIPTION DRUG Oral B Neutra Foam Mint Menthe Sodium Fluoride SOLUTION ORAL 20151008 UNAPPROVED DRUG OTHER YOUNG DENTAL MANUFACTURING CO 1, LLC SODIUM FLUORIDE .5 mg/g N 20181231 0273-0357_658364d8-fe2e-4bc1-8abb-db68a060e949 0273-0357 HUMAN PRESCRIPTION DRUG ZOOBY Spearmint Safari Sodium Fluoride AEROSOL, FOAM DENTAL 20100801 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC SODIUM FLUORIDE 2.72 g/100g N 20181231 0273-0358_c288236a-9ea9-4ce1-984f-0ba8f80af973 0273-0358 HUMAN PRESCRIPTION DRUG ZOOBY Growlin Grrrape Sodium Fluoride AEROSOL, FOAM DENTAL 20100801 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC SODIUM FLUORIDE 2.72 g/100g N 20181231 0273-0370_a473c7dd-3ad6-445d-8864-bde10103c1bc 0273-0370 HUMAN PRESCRIPTION DRUG ZOOBY Gator Gum Sodium Fluoride AEROSOL, FOAM DENTAL 20100801 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC SODIUM FLUORIDE 2.72 g/100g N 20181231 0273-0392_569947be-56fb-4aab-8ed3-25dabfb81e20 0273-0392 HUMAN PRESCRIPTION DRUG ZOOBY Chocolate Chow Sodium Fluoride AEROSOL, FOAM DENTAL 20100801 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC SODIUM FLUORIDE 2.72 g/100g N 20181231 0273-0393_10c9b613-79eb-46b9-85b4-434ee4fa8019 0273-0393 HUMAN PRESCRIPTION DRUG ZOOBY Happy Hippo Cake Sodium Fluoride AEROSOL, FOAM DENTAL 20100801 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC SODIUM FLUORIDE 2.72 g/100g N 20181231 0273-0394_af65f399-593d-4476-8866-41efe4b1bba0 0273-0394 HUMAN PRESCRIPTION DRUG ZOOBY Turtle Melon Sodium Fluoride AEROSOL, FOAM DENTAL 20100801 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC SODIUM FLUORIDE 2.72 g/100g N 20181231 0273-7001_604f71ed-192a-68db-e053-2991aa0a900b 0273-7001 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 20191231 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE; HYDROFLUORIC ACID 7.9; 4.4 mg/g; mg/g N 20181231 0273-7002_604e1d69-0c02-fcf3-e053-2a91aa0abaae 0273-7002 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 20200731 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. HYDROFLUORIC ACID; SODIUM FLUORIDE 4.4; 7.9 mg/g; mg/g N 20181231 0273-7003_604ef6a7-e6e4-614d-e053-2a91aa0a9d7f 0273-7003 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 20201231 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE; HYDROFLUORIC ACID 7.9; 4.4 mg/g; mg/g N 20181231 0273-7004_604e5e57-3b73-3da0-e053-2991aa0a55f8 0273-7004 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 20200930 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE; HYDROFLUORIC ACID 7.9; 4.4 g/g; mg/g N 20181231 0273-7005_604fab6a-d390-5544-e053-2a91aa0ab894 0273-7005 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 20201130 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE; HYDROFLUORIC ACID 7.9; 4.4 mg/g; mg/g N 20181231 0273-7006_602bccf1-4055-c08f-e053-2991aa0a3a3e 0273-7006 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 20200430 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE; HYDROFLUORIC ACID 7.9; 4.4 mg/g; mg/g N 20181231 0273-7007_604e7a8b-b655-7bea-e053-2a91aa0a6f8b 0273-7007 HUMAN PRESCRIPTION DRUG Perfect Choice Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20060831 20201231 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE; HYDROFLUORIC ACID 7.9; 4.4 mg/g; mg/g N 20181231 0273-8001_bd5da8e8-d671-4539-ae06-a10ef1337752 0273-8001 HUMAN PRESCRIPTION DRUG NAFRINSE UNIT DOSE FLUORIDE Sodium Fluoride SOLUTION DENTAL 20170924 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 20 mg/10mL N 20181231 0273-8002_9fddc354-a08a-4e76-9210-9832d58178ce 0273-8002 HUMAN PRESCRIPTION DRUG NAFRINSE UNIT DOSE MINT FLAVOR Sodium Fluoride and Hydrofluoric Acid SOLUTION DENTAL 20170824 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 2 mg/mL N 20181231 0273-8003_9fddc354-a08a-4e76-9210-9832d58178ce 0273-8003 HUMAN PRESCRIPTION DRUG NAFRINSE UNIT DOSE BUBBLE GUM Sodium Fluoride and Hydrofluoric Acid SOLUTION DENTAL 20170824 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 2 mg/mL N 20181231 0273-8004_9fddc354-a08a-4e76-9210-9832d58178ce 0273-8004 HUMAN PRESCRIPTION DRUG NAFRINSE UNIT DOSE BUBBLE GUM Sodium Fluoride and Hydrofluoric Acid SOLUTION DENTAL 20170824 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 2 mg/mL N 20181231 0273-8005_9fddc354-a08a-4e76-9210-9832d58178ce 0273-8005 HUMAN PRESCRIPTION DRUG NAFRINSE UNIT DOSE VERRY BERRY Sodium Fluoride and Hydrofluoric Acid SOLUTION DENTAL 20170824 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 2 mg/mL N 20181231 0273-8007_b8ecc7c2-f35a-47db-9274-47a0bb815e8f 0273-8007 HUMAN PRESCRIPTION DRUG NAFRINSE PACKETSKIT MINT Sodium Fluoride POWDER DENTAL 20170925 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 1 g/g N 20181231 0273-8008_701f1b9e-18b3-441d-aca4-8103518700a6 0273-8008 HUMAN PRESCRIPTION DRUG NAFRINSE PACKETSKIT Bubble Gum Sodium Fluoride POWDER DENTAL 20170925 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 1 g/g N 20181231 0273-8009_522d6973-a983-41e1-80e7-727a062aedad 0273-8009 HUMAN PRESCRIPTION DRUG NAFRINSE PACKETSKIT Grape Sodium Fluoride POWDER DENTAL 20170925 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 1 g/g N 20181231 0273-8010_c5589729-aaad-4d1d-8090-40cfd97e39d0 0273-8010 HUMAN PRESCRIPTION DRUG NAFRINSE PACKETSKIT VERY BERRY Sodium Fluoride POWDER DENTAL 20170925 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 1 g/g N 20181231 0273-8011_3146eba5-aea7-4046-ac8d-333e5ffbe004 0273-8011 HUMAN PRESCRIPTION DRUG FLUORISHIELD Sodium Fluoride GEL DENTAL 20170921 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 11 mg/g N 20181231 0273-8012_87874094-507a-4b54-bfb9-a55a89f5ea99 0273-8012 HUMAN PRESCRIPTION DRUG NAFRINSE PACKETS VERY BERRY Sodium Fluoride POWDER DENTAL 20170921 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 1 g/g N 20181231 0273-8013_72218465-904d-4244-bb19-246efa631b61 0273-8013 HUMAN PRESCRIPTION DRUG NAFRINSE PACKETS MINT Sodium Fluoride POWDER DENTAL 20170921 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 1 g/g N 20181231 0273-8014_bf37919a-7211-4776-8aad-9e7763b9bff3 0273-8014 HUMAN PRESCRIPTION DRUG NAFRINSE PACKETS BUBBLE GUM Sodium Fluoride POWDER DENTAL 20170921 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 1 g/g N 20181231 0273-8015_c9a76f61-2712-4964-8c44-cb3b9f3fe698 0273-8015 HUMAN PRESCRIPTION DRUG NAFRINSE PACKETS GRAPE Sodium Fluoride POWDER DENTAL 20170921 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 1 g/g N 20181231 0273-8016_b9f7d795-4c69-423a-8038-1bd00772f6c9 0273-8016 HUMAN PRESCRIPTION DRUG NAFRINSE PACKETS VERY BERRY Sodium Fluoride POWDER DENTAL 20170921 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 1 g/g N 20181231 0273-8017_a933ec1e-ea91-49b3-95dd-a66973976fbe 0273-8017 HUMAN PRESCRIPTION DRUG NAFRINSE PACKETS MINT Sodium Fluoride POWDER DENTAL 20170921 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 1 g/g N 20181231 0273-8018_71a28cd3-9f3e-4af4-8b02-e3947a2ffb02 0273-8018 HUMAN PRESCRIPTION DRUG NAFRINSE PACKETS BUBBLE GUM Sodium Fluoride POWDER DENTAL 20170921 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 1 g/g N 20181231 0273-8020_0bc748f9-75af-429b-a885-beda06f66816 0273-8020 HUMAN PRESCRIPTION DRUG NAFRINSE PACKETS GRAPE Sodium Fluoride POWDER DENTAL 20170921 UNAPPROVED DRUG OTHER Young Dental Manufacturing Co 1, LLC. SODIUM FLUORIDE 1 g/g N 20181231 0280-0030_5758c657-7c67-57c6-e053-2a91aa0acff2 0280-0030 HUMAN OTC DRUG PHILLIPS ORIGINAL MILK OF MAGNESIA PHILLIPS ORIGINAL MILK OF MAGNESIA LIQUID ORAL 20141216 OTC MONOGRAPH NOT FINAL part334 Bayer HealthCare LLC. MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0280-0031_51c7aa14-14cc-5853-e054-00144ff8d46c 0280-0031 HUMAN OTC DRUG PHILLIPS FRESH MINT MILK OF MAGNESIA PHILLIPS FRESH MINT MILK OF MAGNESIA LIQUID ORAL 20141216 OTC MONOGRAPH NOT FINAL part334 Bayer HealthCare LLC. MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0280-0032_5759461e-4c1e-34ea-e053-2991aa0abffa 0280-0032 HUMAN OTC DRUG Phillips Milk Of Magnesia Wild Cherry Phillips Milk Of Magnesia Wild Cherry LIQUID ORAL 20141217 OTC MONOGRAPH NOT FINAL part334 Bayer HealthCare LLC. MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0280-0033_51d935ab-8b12-5f78-e054-00144ff8d46c 0280-0033 HUMAN OTC DRUG Phillips Milk of Magnesia Concentrated Fresh Strawberry Phillips Milk of Magnesia Concentrated Fresh Strawberry LIQUID ORAL 20141218 OTC MONOGRAPH NOT FINAL part334 Bayer HealthCare LLC. MAGNESIUM HYDROXIDE 2400 mg/15mL N 20181231 0280-0042_51759451-63a9-0fb4-e054-00144ff8d46c 0280-0042 HUMAN OTC DRUG Alka-Seltzer Extra Strength Heartburn ReliefChews Calcium carbonate TABLET, CHEWABLE ORAL 20160915 OTC MONOGRAPH FINAL part331 Bayer HealthCare LLC. CALCIUM CARBONATE 750 mg/1 N 20181231 0280-0047_55158e50-0328-2043-e054-00144ff8d46c 0280-0047 HUMAN OTC DRUG Alka-Seltzer Heartburn Anhydrous citric acid, Sodium bicarbonate (heat-treated) TABLET, EFFERVESCENT ORAL 20100302 OTC MONOGRAPH FINAL part331 Bayer HealthCare LLC. CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 1000; 1940 mg/1; mg/1 N 20181231 0280-0052_5d932670-f67a-073e-e053-2991aa0ae091 0280-0052 HUMAN OTC DRUG Alka-Seltzer Plus Night Cold Formula (Lemon) Aspirin, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20080430 20190601 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. PHENYLEPHRINE BITARTRATE; ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 7.8; 500; 10; 6.25 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-0056_6063c4fb-c104-9e7e-e053-2a91aa0a482d 0280-0056 HUMAN OTC DRUG Alka-Seltzer Plus Severe Cold and Cough Night Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate LIQUID ORAL 20150731 20180531 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 0280-0072_5fd70ea9-0acc-3013-e053-2991aa0a0736 0280-0072 HUMAN OTC DRUG ClariSpray Nasal Allergy Fluticasone propionate (glucocorticoid) SPRAY, METERED NASAL 20160420 ANDA ANDA208150 Bayer HealthCare LLC. FLUTICASONE PROPIONATE 50 ug/1 N 20181231 0280-0210_504472f7-e953-33c3-e054-00144ff88e88 0280-0210 HUMAN OTC DRUG Campho-Phenique Pain Relieving Antiseptic Liquid camphor, phenol LIQUID TOPICAL 20150119 20181001 OTC MONOGRAPH NOT FINAL part348 Bayer HealthCare LLC. PHENOL; CAMPHOR (NATURAL) 4.7; 10.8 mg/100mL; mg/100mL N 20181231 0280-0211_49b76edf-7eae-5fc0-e054-00144ff8d46c 0280-0211 HUMAN OTC DRUG Alka-Seltzer Extra Strength Anhydrous Citric Acid, Sodium Bicarbonate, and Aspirin GRANULE, EFFERVESCENT ORAL 20110411 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ANHYDROUS CITRIC ACID; SODIUM BICARBONATE; ASPIRIN 1000; 1985; 500 mg/1; mg/1; mg/1 N 20181231 0280-0220_5c79ed17-11ab-d59b-e053-2991aa0a35de 0280-0220 HUMAN OTC DRUG Campho Phenique Cold Sore Treatment Camphor,Phenol GEL TOPICAL 20150220 20181101 OTC MONOGRAPH NOT FINAL part348 Bayer HealthCare LLC. CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 g/100g; g/100g N 20181231 0280-0221_4ecb7106-afae-01a7-e054-00144ff8d46c 0280-0221 HUMAN OTC DRUG Alka-Seltzer Heartburn ReliefChews CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20140315 OTC MONOGRAPH FINAL part331 Bayer HealthCare LLC. CALCIUM CARBONATE 750 mg/1 N 20181231 0280-0224_5c89937d-243b-902e-e053-2a91aa0accf4 0280-0224 HUMAN OTC DRUG Alka-Seltzer Heartburn ReliefChews Strawberry and Orange CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20140315 OTC MONOGRAPH FINAL part331 Bayer HealthCare LLC. CALCIUM CARBONATE 750 mg/1 N 20181231 0280-0225_4eca0d0f-58cb-31b3-e054-00144ff8d46c 0280-0225 HUMAN OTC DRUG Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical Punch CALCIUM CARBONATE AND SIMETHICONE TABLET, CHEWABLE ORAL 20140315 OTC MONOGRAPH FINAL part331 Bayer HealthCare LLC. DIMETHICONE; CALCIUM CARBONATE 80; 750 mg/1; mg/1 N 20181231 0280-0230_5c79cedc-44e8-a3f2-e053-2991aa0a1bb1 0280-0230 HUMAN OTC DRUG CAMPHO-PHENIQUE ANTISEPTIC Gel camphor, phenol GEL TOPICAL 20150126 20181101 OTC MONOGRAPH NOT FINAL part348 Bayer HealthCare LLC. PHENOL; CAMPHOR (NATURAL) 4.7; 10.8 g/100g; g/100g N 20181231 0280-0270_5c782be3-1738-2ba0-e053-2991aa0a298e 0280-0270 HUMAN OTC DRUG Menstridol NAPROXEN SODIUM TABLET ORAL 20140701 NDA NDA020204 Bayer HealthCare LLC. NAPROXEN SODIUM 220 mg/1 N 20181231 0280-0505_5201474e-e56c-7336-e054-00144ff8d46c 0280-0505 HUMAN OTC DRUG Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels Alka-Seltzer Plus Severe Cough Mucus and Congestion CAPSULE, LIQUID FILLED ORAL 20150107 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 5; 250; 200; 10 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-0506_5278a128-41ed-4494-e054-00144ff8d46c 0280-0506 HUMAN OTC DRUG Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride, Guaifenesin KIT ORAL 20170530 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. N 20181231 0280-0507_5251cd97-d94b-6a9d-e054-00144ff88e88 0280-0507 HUMAN OTC DRUG Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid Gels Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20150128 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 250; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-0800_5d928949-0857-078e-e053-2991aa0a74ee 0280-0800 HUMAN OTC DRUG Bronkaid Dual Action Formula EPHEDRINE SULFATE and GUAIFENESIN TABLET, COATED ORAL 20060101 20180630 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. EPHEDRINE SULFATE; GUAIFENESIN 25; 400 mg/1; mg/1 N 20181231 0280-0921_5c886d17-6a06-7c90-e053-2a91aa0aad3d 0280-0921 HUMAN OTC DRUG Alka-Seltzer Plus Day Severe Cold Plus Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION ORAL 20140417 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 400; 10 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-0922_5c886d17-6a1c-7c90-e053-2a91aa0aad3d 0280-0922 HUMAN OTC DRUG Alka-Seltzer Plus Night Severe Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION ORAL 20140417 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-0923_602795f6-dbbc-1747-e053-2991aa0aa1ab 0280-0923 HUMAN OTC DRUG Alka-Seltzer Plus Severe Sinus and Cold ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION ORAL 20140417 20180731 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 4; 20; 10 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-0924_5e929827-efae-4950-e053-2a91aa0a2f5a 0280-0924 HUMAN OTC DRUG Alka-Seltzer Plus Day and Night Severe Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, and Doxylamine succinate KIT 20140701 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. N 20181231 0280-1012_57825c04-dc89-b76d-e053-2991aa0a4c1d 0280-1012 HUMAN OTC DRUG Phillips Stool Softener Bulk Docusate docusate sodium CAPSULE, LIQUID FILLED ORAL 20130902 OTC MONOGRAPH NOT FINAL part334 Bayer HealthCare LLC. DOCUSATE SODIUM 100 mg/1 N 20181231 0280-1121_56cda727-02c3-475d-e054-00144ff88e88 0280-1121 HUMAN OTC DRUG Alka-Seltzer Plus Cold and Cough Formula ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20131030 20190430 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1122_56e0ffef-8b62-356a-e054-00144ff8d46c 0280-1122 HUMAN OTC DRUG Alka-Seltzer Plus Severe Sinus Congestion and Cough Day and Night Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, and Doxylamine succinate KIT 20131030 20180531 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC N 20181231 0280-1124_56cc72ac-2103-1bab-e054-00144ff8d46c 0280-1124 HUMAN OTC DRUG Alka-Seltzer Plus Night Cold and Flu Formula ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130708 20180930 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1125_56e3e183-7c96-33b2-e054-00144ff88e88 0280-1125 HUMAN OTC DRUG Alka-Seltzer Plus Severe Sinus Congestion, Allergy and Cough ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20131030 20181130 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1126_56e10b88-ad5c-198f-e054-00144ff8d46c 0280-1126 HUMAN OTC DRUG Alka-Seltzer Plus Day and Night Cold and Flu Formula Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, and Doxylamine succinate KIT 20131030 20180831 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. N 20181231 0280-1134_56cc21fd-f5cb-1b52-e054-00144ff88e88 0280-1134 HUMAN OTC DRUG Alka-Seltzer Plus Day Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130730 20180731 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0280-1135_56e11a36-e225-3623-e054-00144ff8d46c 0280-1135 HUMAN OTC DRUG Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20140501 20180731 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDRIODIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0280-1136_5ae15ff1-6389-bf46-e053-2a91aa0ac102 0280-1136 HUMAN OTC DRUG Alka-Seltzer Plus Multi-Symptom Cold and Flu Day Liquid Gels Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20160701 OTC MONOGRAPH NOT FINAL part343 Bayer Healthcare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0280-1137_56df3097-e294-501e-e054-00144ff8d46c 0280-1137 HUMAN OTC DRUG Alka-Seltzer Plus Multi-Smptom Cold and Flu Night Acetaminophen, Dextromethorphan HBr, Doxylamine sucinate, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20160701 20180630 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 6.25; 5; 325; 10 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1138_5ae0f1b1-ae07-2093-e053-2991aa0a69ef 0280-1138 HUMAN OTC DRUG Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT ORAL 20160715 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC. N 20181231 0280-1140_5fd62db8-0cb9-4740-e053-2991aa0a3694 0280-1140 HUMAN OTC DRUG Alka-Seltzer Plus Day and Night Cold Alka-Seltzer Plus Day and Night Cold KIT 20150109 20181101 OTC MONOGRAPH NOT FINAL part341 Bayer HealthCare LLC. N 20181231 0280-1159_d5292b72-8900-4eaf-96d7-5bc0eafc7113 0280-1159 HUMAN OTC DRUG Alka-Seltzer Plus Severe Cold, Mucus and Congestion Acetaminophen, Dextromethorphan hydrobromide, guaifenesin, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20130801 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC, Consumer Care ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 250; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1200_55c4de2b-84b4-1497-e054-00144ff88e88 0280-1200 HUMAN OTC DRUG Aleve PM DIPHENHYDRAMINE HYDROCHLORIDE and NAPROXEN SODIUM TABLET, FILM COATED ORAL 20140909 NDA NDA205352 Bayer HealthCare LLC. DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM 25; 220 mg/1; mg/1 N 20181231 0280-1207_514acc92-3ddd-5f40-e054-00144ff88e88 0280-1207 HUMAN OTC DRUG Alka-Seltzer Plus Sore Throat Relief Honey Lemon Flavor Acetaminophen TABLET, ORALLY DISINTEGRATING ORAL 20170629 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ACETAMINOPHEN 325 mg/1 N 20181231 0280-1211_5d9340bf-91e4-7f15-e053-2a91aa0a1195 0280-1211 HUMAN OTC DRUG Alka-Seltzer Plus Sore Throat Relief Cool Menthol Flavor Acetaminophen TABLET, ORALLY DISINTEGRATING ORAL 20170629 20190801 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ACETAMINOPHEN 325 mg/1 N 20181231 0280-1212_52e2f7c5-3520-3fae-e054-00144ff88e88 0280-1212 HUMAN OTC DRUG Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels with Cool Menthol Flavor Liquid Gels Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170619 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN 2; 10; 5; 325 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1221_480679cb-e7c4-52a0-e054-00144ff88e88 0280-1221 HUMAN OTC DRUG Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels Day Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170227 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN 10; 5; 325 mg/1; mg/1; mg/1 N 20181231 0280-1222_480679cb-e7c4-52a0-e054-00144ff88e88 0280-1222 HUMAN OTC DRUG Alka-Seltzer Plus Severe Sinus Congestion and Cough Liquid Gels Night Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170227 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1400_5d12fb35-76ee-2bc0-e053-2a91aa0a7c2f 0280-1400 HUMAN OTC DRUG Alka-Seltzer Plus Cold Medicine Sparkling Original ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20080410 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 N 20181231 0280-1420_5d932670-f661-073e-e053-2991aa0ae091 0280-1420 HUMAN OTC DRUG Alka-Seltzer Plus Cold and Cough Formula Aspirin, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20080519 20190601 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ASPIRIN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE 325; 2; 10; 7.8 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1435_9863be79-e7e8-485b-8e01-14fc724e4b32 0280-1435 HUMAN OTC DRUG Alka-Seltzer Plus Night Cold and Flu Formula Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20120530 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC - Consumer Care ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 0280-1440_5d930d6d-323a-9036-e053-2a91aa0a8d0a 0280-1440 HUMAN OTC DRUG Alka-Seltzer Plus Cold Formula (Orange Zest) Aspirin, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20080410 20190601 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 N 20181231 0280-1510_53188c41-3f14-311b-e054-00144ff88e88 0280-1510 HUMAN OTC DRUG Alka-Seltzer Plus Cold Orange Zest Aspirin, Chlorpheniramine Maleate, Phenylephrine bitartrate TABLET, EFFERVESCENT ORAL 20170715 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 N 20181231 0280-1520_531ab703-179b-70ad-e054-00144ff88e88 0280-1520 HUMAN OTC DRUG Alka-Seltzer Plus Cold Sparkling Original Aspirin, Chlorpheniramine maleate, Phenylephrine bitartrate TABLET, EFFERVESCENT ORAL 20170703 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE 325; 7.8; 2 mg/1; mg/1; mg/1 N 20181231 0280-1530_540aea6c-f9f0-5f0e-e054-00144ff8d46c 0280-1530 HUMAN OTC DRUG Alka-Seltzer Plus Multi-Symptom Cold and Cough Aspirin, Phenylephrine Bitartrate, Dextromethorphan Hydrobromide, Chlorpheniramine Maleate TABLET, EFFERVESCENT ORAL 20170715 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ASPIRIN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE 325; 2; 10; 7.8 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1540_53933e13-38eb-515f-e054-00144ff8d46c 0280-1540 HUMAN OTC DRUG Alka-Seltzer Plus Multi-Symptom Cold Day and Night Aspirin, Dextromethorphan hydrobromide, Phenylephrine bitartrate KIT ORAL 20170703 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. N 20181231 0280-1541_540f375c-99e7-4444-e054-00144ff8d46c 0280-1541 HUMAN OTC DRUG Alka-Seltzer Plus Multi-Symptom Cold Night Aspirin, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine bitartrate TABLET, EFFERVESCENT ORAL 20170715 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ASPIRIN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE BITARTRATE 500; 6.25; 10; 7.8 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1560_531a86b3-2916-6d55-e054-00144ff88e88 0280-1560 HUMAN OTC DRUG Alka-Seltzer Plus Severe Cold and Flu Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride TABLET, EFFERVESCENT ORAL 20170703 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ASPIRIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE 250; 10; 5; 2 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1570_51dec468-fbb3-3489-e054-00144ff88e88 0280-1570 HUMAN OTC DRUG Alka-Seltzer Plus Maximum Strength Cold and Cough Acetaminophen, Chlorpheniramine malaeate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170616 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN 2; 5; 10; 325 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1580_51c44970-06e6-082e-e054-00144ff88e88 0280-1580 HUMAN OTC DRUG Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride KIT ORAL 20170522 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. N 20181231 0280-1581_54236151-37dc-0b5a-e054-00144ff88e88 0280-1581 HUMAN OTC DRUG Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride KIT ORAL 20170522 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. N 20181231 0280-1590_5172dc01-4e80-3307-e054-00144ff8d46c 0280-1590 HUMAN OTC DRUG Alka-Seltzer Plus Maximum Strength Day Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20170619 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0280-1600_51dca689-e4a1-5526-e054-00144ff88e88 0280-1600 HUMAN OTC DRUG Alka-Seltzer Plus Maximum Strength Night Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170619 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 10; 325; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-1610_52542774-fd06-640c-e054-00144ff8d46c 0280-1610 HUMAN OTC DRUG Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride KIT ORAL 20170612 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. N 20181231 0280-1620_53f72d2a-b946-419a-e054-00144ff8d46c 0280-1620 HUMAN OTC DRUG Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170626 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-2000_5c77b15c-508c-2e00-e053-2a91aa0aee50 0280-2000 HUMAN OTC DRUG Bayer Genuine Aspirin Aspirin TABLET ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ASPIRIN 325 mg/1 N 20181231 0280-2011_58991e29-288f-9f08-e053-2991aa0aa3cf 0280-2011 HUMAN OTC DRUG Alka-Seltzer Plus Sore Throat Relief Cool Mint Flavor Acetaminophen TABLET, ORALLY DISINTEGRATING ORAL 20170908 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ACETAMINOPHEN 325 mg/1 N 20181231 0280-2020_598c367d-63b4-0a6d-e053-2a91aa0af5f0 0280-2020 HUMAN OTC DRUG BAYER Aspirin Extra Strength Caplets BAYER Aspirin Extra Strength TABLET ORAL 20141223 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ASPIRIN 500 mg/1 N 20181231 0280-2040_5c77dd2e-34fe-c738-e053-2991aa0a89f0 0280-2040 HUMAN OTC DRUG Bayer Plus Extra Strength Aspirin TABLET, COATED ORAL 20150112 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ASPIRIN 500 mg/1 N 20181231 0280-2080_598c6acd-766c-a740-e053-2991aa0a7dfa 0280-2080 HUMAN OTC DRUG Bayer Aspirin Regimen Chewable Low Dose Aspirin Orange Aspirin TABLET, CHEWABLE ORAL 20150111 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ASPIRIN 81 mg/1 N 20181231 0280-2090_598bc765-724f-0f31-e053-2a91aa0abb65 0280-2090 HUMAN OTC DRUG Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry Flavored Aspirin TABLET, CHEWABLE ORAL 20020702 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ASPIRIN 81 mg/1 N 20181231 0280-2100_58757b5b-37e9-7192-e053-2a91aa0aaf68 0280-2100 HUMAN OTC DRUG Bayer Low Dose Aspirin TABLET ORAL 20020712 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC. ASPIRIN 81 mg/1 N 20181231 0280-2110_4ea1b983-b27d-4f8a-e054-00144ff8d46c 0280-2110 HUMAN OTC DRUG Bayer Aspirin Regimen enteric coated Aspirin TABLET, COATED ORAL 20150111 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ASPIRIN 325 mg/1 N 20181231 0280-2150_55c4de2b-84ce-1497-e054-00144ff88e88 0280-2150 HUMAN OTC DRUG Bayer Back and Body Extra Strength Aspirin,Caffeine TABLET ORAL 20150112 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. CAFFEINE; ASPIRIN 35.5; 500 mg/1; mg/1 N 20181231 0280-2200_60a18f6b-5d74-29af-e053-2a91aa0ab282 0280-2200 HUMAN OTC DRUG Bayer Womens Aspirin TABLET, COATED ORAL 20150109 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ASPIRIN; CALCIUM CARBONATE 81; 777 mg/1; mg/1 N 20181231 0280-2635_328e2d1e-22e0-49c1-bb3e-7eb162377cc2 0280-2635 HUMAN OTC DRUG Bayer Headache Relief Aspirin and Caffeine CAPSULE ORAL 20120601 OTC MONOGRAPH FINAL part343 Bayer HealthCare LLC ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 N 20181231 0280-4000_4f5a429f-013e-0e39-e054-00144ff88e88 0280-4000 HUMAN OTC DRUG Alka-Seltzer Original ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20100302 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 325; 1916 mg/1; mg/1; mg/1 N 20181231 0280-4020_49c4075a-f4bb-68ab-e054-00144ff8d46c 0280-4020 HUMAN OTC DRUG Alka-Seltzer Lemon Lime Alka-Seltzer Lemon Lime TABLET, EFFERVESCENT ORAL 20141107 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ANHYDROUS CITRIC ACID; SODIUM BICARBONATE; ASPIRIN 1000; 1700; 325 mg/1; mg/1; mg/1 N 20181231 0280-4100_4ec81e1c-f0f6-4529-e054-00144ff8d46c 0280-4100 HUMAN OTC DRUG Alka-Seltzer Gold Alka-Seltzer Gold TABLET, EFFERVESCENT ORAL 20141119 OTC MONOGRAPH FINAL part331 Bayer HealthCare LLC. CITRIC ACID MONOHYDRATE; POTASSIUM BICARBONATE; SODIUM BICARBONATE 1000; 344; 1050 mg/1; mg/1; mg/1 N 20181231 0280-6000_5499c415-3543-6dca-e054-00144ff8d46c 0280-6000 HUMAN OTC DRUG Aleve Caplets NAPROXEN SODIUM TABLET ORAL 20140226 NDA NDA020204 Bayer HealthCare LLC. NAPROXEN SODIUM 220 mg/1 N 20181231 0280-6010_549a252a-a81e-0580-e054-00144ff88e88 0280-6010 HUMAN OTC DRUG Aleve NAPROXEN SODIUM TABLET ORAL 20020726 NDA NDA020204 Bayer HealthCare LLC. NAPROXEN SODIUM 220 mg/1 N 20181231 0280-6020_54abdede-326e-6956-e054-00144ff8d46c 0280-6020 HUMAN OTC DRUG Aleve Gelcaps NAPROXEN SODIUM TABLET, COATED ORAL 20020801 NDA NDA020204 Bayer HealthCare LLC. NAPROXEN SODIUM 220 mg/1 N 20181231 0280-6045_5ab980c0-c48b-233b-e053-2991aa0a4fd1 0280-6045 HUMAN OTC DRUG Aleve-D Sinus and Headache naproxen sodium, pseudoephedrine hydrochloride TABLET ORAL 20140101 ANDA ANDA076518 Bayer HealthCare LLC. NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 0280-6050_549a252a-a802-0580-e054-00144ff88e88 0280-6050 HUMAN OTC DRUG Aleve Caplets - Easy Open Arthritis Cap NAPROXEN SODIUM TABLET ORAL 20131111 NDA NDA020204 Bayer HealthCare LLC. NAPROXEN SODIUM 220 mg/1 N 20181231 0280-6060_5499ffef-c5f4-0a5b-e054-00144ff8d46c 0280-6060 HUMAN OTC DRUG Aleve Easy Open Arthritis Cap NAPROXEN SODIUM TABLET ORAL 20020726 NDA NDA020204 Bayer HealthCare LLC. NAPROXEN SODIUM 220 mg/1 N 20181231 0280-6070_54c00983-9fe5-31f7-e054-00144ff88e88 0280-6070 HUMAN OTC DRUG Aleve Gelcaps NAPROXEN SODIUM TABLET, COATED ORAL 20020801 NDA NDA020204 Bayer HealthCare LLC. NAPROXEN SODIUM 220 mg/1 N 20181231 0280-6080_549ba828-f595-3575-e054-00144ff88e88 0280-6080 HUMAN OTC DRUG Aleve Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20070220 NDA NDA021920 Bayer HealthCare LLC. NAPROXEN SODIUM 220 mg/1 N 20181231 0280-6090_599ea6c8-03ae-536e-e053-2991aa0a83a3 0280-6090 HUMAN OTC DRUG Aleve-D Sinus and Cold naproxen sodium, pseudeoephedrine hydrochloride TABLET ORAL 20140101 ANDA ANDA076518 Bayer HealthCare LLC. NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 0280-6091_549a6cf5-4f91-0ea1-e054-00144ff88e88 0280-6091 HUMAN OTC DRUG Aleve Easy Open Arthritis Cap Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20070228 NDA NDA021920 Bayer HealthCare LLC. NAPROXEN SODIUM 220 mg/1 N 20181231 0280-6092_6376e1b8-52c5-0519-e053-2a91aa0af35f 0280-6092 HUMAN OTC DRUG Aleve Back and Muscle Pain Naproxen Sodium TABLET ORAL 20180126 NDA NDA020204 Bayer HealthCare LLC. NAPROXEN SODIUM 220 mg/1 N 20191231 0280-7055_60c935d9-15bb-1457-e053-2a91aa0aec23 0280-7055 HUMAN OTC DRUG Alka-Seltzer Plus Severe Cold And Flu Formula Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine maleate, and Phenylephrine hydrochloride GRANULE, EFFERVESCENT ORAL 20120702 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 250; 10; 2; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0280-7190_67c3f7fd-6ce6-4489-96a2-c1af17b3f51c 0280-7190 HUMAN OTC DRUG Alka-Seltzer Plus Fast Packs Cold and Flu Formula Acetaminophen, Chlorpheniramine maleate, and Phenylephrine Hydrochloride GRANULE, EFFERVESCENT ORAL 20100801 OTC MONOGRAPH FINAL part341 Bayer Corporation Consumer Care Division ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 4; 10 mg/1; mg/1; mg/1 N 20181231 0280-8005_5d659b6f-b2d1-8946-e053-2a91aa0a19f9 0280-8005 HUMAN OTC DRUG Midol Complete ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE TABLET ORAL 20140210 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 0280-8015_5de37e93-808b-0594-e053-2991aa0a1e32 0280-8015 HUMAN OTC DRUG Midol Complete Gelcaps Midol Complete TABLET, COATED ORAL 20141215 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC CAFFEINE; PYRILAMINE MALEATE; ACETAMINOPHEN 60; 15; 500 mg/1; mg/1; mg/1 N 20181231 0280-8030_0733f148-0745-4bb3-e054-00144ff8d46c 0280-8030 HUMAN OTC DRUG Midol Teen Midol Teen TABLET, COATED ORAL 20030701 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC ACETAMINOPHEN; PAMABROM 500; 25 mg/1; mg/1 N 20181231 0280-8070_09b9c5d8-c725-2bb4-e054-00144ff8d46c 0280-8070 HUMAN OTC DRUG Midol PM Midol PM TABLET, COATED ORAL 20141215 OTC MONOGRAPH NOT FINAL part343 Bayer HealthCare LLC ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 N 20181231 0280-8090_4a3a711d-c883-3525-e054-00144ff8d46c 0280-8090 HUMAN OTC DRUG Midol Long Lasting Relief Acetaminophen TABLET, EXTENDED RELEASE ORAL 20170310 ANDA ANDA075077 Bayer HealthCare LLC. ACETAMINOPHEN 650 mg/1 N 20181231 0280-9000_60266e30-1440-47f3-e053-2a91aa0a95b8 0280-9000 HUMAN OTC DRUG RID Lice Killing Piperonyl butoxide and pyrethrum extract SHAMPOO TOPICAL 20100301 OTC MONOGRAPH FINAL part358G Bayer HealthCare LLC. PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 40; 3.3 mg/mL; mg/mL N 20181231 0280-9050_3a1cd252-623c-3346-e054-00144ff88e88 0280-9050 HUMAN OTC DRUG RID Lice Treatment Complete Kit RID Lice Treatment Complete Kit KIT TOPICAL 20160509 OTC MONOGRAPH FINAL part358 Bayer HealthCare LLC N 20181231 0280-9070_3d927d10-6d83-1cab-e054-00144ff88e88 0280-9070 HUMAN OTC DRUG RID Lice Elimination Essentials Piperonyl Butoxide, Pyrethrum Extract KIT TOPICAL 20160928 OTC MONOGRAPH FINAL part358G Bayer HealthCare LLC N 20181231 0281-0326_a5c6d059-3e40-4813-8e8a-44d026d3bf43 0281-0326 HUMAN PRESCRIPTION DRUG NITRO-BID Nitroglycerin OINTMENT TOPICAL 20090815 ANDA ANDA087355 Savage Laboratories a division of Fougera Pharmaceuticals Inc. NITROGLYCERIN 20 mg/g Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0281-0365_e4b895ab-8a6f-46b0-ad84-f4cae6158049 0281-0365 HUMAN PRESCRIPTION DRUG DigiFab ovine digoxin immune fab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010831 BLA BLA103910 SAVAGE LABORATORIES, A division of Nycomed US Inc. OVINE DIGOXIN IMMUNE FAB 38 mg/1 Immunoglobulin G [EPC],Digoxin Binding Activity [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 0283-0293_bed57705-f1f1-44ca-9d7d-395149ad325d 0283-0293 HUMAN OTC DRUG HurriCaine Topical Anesthetic Gel Benzocaine GEL DENTAL; ORAL; PERIODONTAL 19930215 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals, LLC BENZOCAINE 200 mg/g N 20181231 0283-0569_39a7e56a-aaa3-3308-e054-00144ff88e88 0283-0569 HUMAN OTC DRUG HurriCaine Topical Anesthetic Liquid Benzocaine LIQUID DENTAL; ORAL; PERIODONTAL 19690515 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals, LLC BENZOCAINE 200 mg/g N 20181231 0283-0610_97cb53e9-0278-431a-9b53-e5e4a49899c9 0283-0610 HUMAN OTC DRUG HurriCaine Topical Anesthetic SPRAY DENTAL; PERIODONTAL 20100615 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals LLC BENZOCAINE 183 mg/g N 20181231 0283-0679_b08c29a4-a50e-48e0-9dbe-c47ab182e65a 0283-0679 HUMAN OTC DRUG HurriCaine Topical Anesthetic Benzocaine SPRAY DENTAL; ORAL; PERIODONTAL 19790615 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals, LLC BENZOCAINE 200 mg/g N 20181231 0283-0808_fe0fc90b-8151-4cde-b7b9-461840203417 0283-0808 HUMAN OTC DRUG CEO-TWO Laxative SUPPOSITORY RECTAL 20080815 OTC MONOGRAPH NOT FINAL part334 Beutlich Pharmaceuticals, LLC POTASSIUM BITARTRATE; SODIUM BICARBONATE 927; 618 mg/3.7g; mg/3.7g N 20181231 0283-0871_7f358ebd-b8aa-4603-b6c3-12cdbdefde41 0283-0871 HUMAN OTC DRUG HurriCaine Topical Anesthetic BENZOCAINE GEL DENTAL; ORAL; PERIODONTAL 19710815 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals, LLC BENZOCAINE 200 mg/g N 20181231 0283-0871_e273ecc7-fef5-45de-8ee2-d8ac8f66e6c3 0283-0871 HUMAN OTC DRUG HurriCaine Topical Anesthetic Benzocaine GEL DENTAL; ORAL; PERIODONTAL 19710815 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals, LLC BENZOCAINE 200 mg/g N 20181231 0283-0886_3fb30266-41c3-489a-aacf-3ffb9104c6fa 0283-0886 HUMAN OTC DRUG HurriCaine Topical Anesthetic Gel Benzocaine GEL DENTAL; ORAL; PERIODONTAL 19860815 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals, LLC BENZOCAINE 200 mg/g N 20181231 0283-0914_3988c038-fd3b-4ea1-8982-0de94d7a814d 0283-0914 HUMAN OTC DRUG HurriCaine Topical Anesthetic Benzocaine SPRAY DENTAL; ORAL; PERIODONTAL 20140901 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals, LLC BENZOCAINE 200 mg/g N 20181231 0283-0998_1131af9d-48b0-371a-e054-00144ff8d46c 0283-0998 HUMAN OTC DRUG HurriCaine Topical Anesthetic Benzocaine GEL DENTAL; PERIODONTAL 19980915 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals LLC BENZOCAINE 200 mg/g N 20181231 0283-1016_b4ecbd6c-aeea-413e-8433-c5ee9ac195cb 0283-1016 HUMAN OTC DRUG HurriCaine Topical Anesthetic BENZOCAINE GEL DENTAL; ORAL; PERIODONTAL 20161015 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals, LLC BENZOCAINE 200 mg/g N 20181231 0283-1116_f8bf9ce8-eb43-451c-9c79-726b9f6c866d 0283-1116 HUMAN OTC DRUG HurriCaine Topical Anesthetic Liquid Benzocaine LIQUID DENTAL; ORAL; PERIODONTAL 20161115 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals, LLC BENZOCAINE 200 mg/g N 20181231 0283-1886_7294093d-71ca-4240-91a4-496e592ee72f 0283-1886 HUMAN OTC DRUG HurriCaine Topical Anesthetic Liquid Benzocaine LIQUID DENTAL; ORAL; PERIODONTAL 19860815 OTC MONOGRAPH NOT FINAL part356 Beutlich Pharmaceuticals, LLC BENZOCAINE 200 mg/g N 20181231 0288-1106_75d5beb2-d3d8-4e78-8df1-081095a53774 0288-1106 HUMAN PRESCRIPTION DRUG FLUORITAB CHEWABLE CHERRY SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20110109 UNAPPROVED DRUG OTHER Fluoritab Corporation SODIUM FLUORIDE .5 mg/1 E 20171231 0288-2203_2448eb27-df71-4bb1-814a-4766458a9505 0288-2203 HUMAN PRESCRIPTION DRUG FLUORITAB CHEWABLE CHERRY SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20110109 UNAPPROVED DRUG OTHER Fluoritab Corporation SODIUM FLUORIDE 1 mg/1 E 20171231 0288-5523_3a30ff5c-7903-465a-af66-21f0c24b5e3a 0288-5523 HUMAN PRESCRIPTION DRUG FLUORIDE DROPS SODIUM FLUORIDE LIQUID ORAL 20110109 UNAPPROVED DRUG OTHER Fluoritab Corporation SODIUM FLUORIDE 2.5 mg/mL E 20171231 0295-0010_0b54a8d6-968e-49cb-afac-bc5c99e19544 0295-0010 HUMAN OTC DRUG Zapzyt Acne benzoyl peroxide GEL TOPICAL 20170101 OTC MONOGRAPH FINAL part333D Denison Pharmaceuticals, Inc. BENZOYL PEROXIDE 10 g/100g N 20191231 0295-1183_07851160-5cbe-4206-9455-36dbee16d474 0295-1183 HUMAN OTC DRUG Decolorized Iodine Iodides tincture LIQUID TOPICAL 19640701 OTC MONOGRAPH FINAL part331 Denison Pharmaceuticals, Inc. ALCOHOL .48 mL/mL N 20181231 0295-1223_0cd64cba-f266-4875-b7ab-057d33ed854f 0295-1223 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 19790822 OTC MONOGRAPH FINAL part331 Denison Pharmaceuticals, Inc. BACITRACIN 500 [USP'U]/g N 20181231 0295-1749_1175fc94-7fac-46c2-a7c9-f6568c1deeb1 0295-1749 HUMAN OTC DRUG Chloraseptic Sore Throat Max Phenol and Glycerin SPRAY ORAL 20110201 OTC MONOGRAPH NOT FINAL part356 Denison Pharmaceuticals, Inc. PHENOL; GLYCERIN 15; 330 mg/mL; mg/mL N 20191231 0295-9116_0fee6b3b-a97a-4b90-b2cb-2097ed3e80d6 0295-9116 HUMAN OTC DRUG Adult Acnomel Tinted resorcinol 2.00% sulfur 8.00% CREAM TOPICAL 20170101 OTC MONOGRAPH FINAL part333D Denison Pharmaceuticals, Inc. RESORCINOL; SULFUR 2; 8 g/100g; g/100g N 20191231 0299-2012_65b7ce60-597b-46bd-9fe5-39e8723c1492 0299-2012 HUMAN PRESCRIPTION DRUG Vectical calcitriol OINTMENT TOPICAL 20090201 NDA NDA022087 Galderma Laboratories, L.P. CALCITRIOL 3 ug/g Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0299-3674_067a768a-9131-4e0e-90a6-21a50c686cfe 0299-3674 HUMAN OTC DRUG Benzac salicylic acid GEL TOPICAL 20141201 OTC MONOGRAPH FINAL part333D Galderma Laboratories, L.P. SALICYLIC ACID .5 g/100g N 20181231 0299-3674_0dd67012-6278-4c04-ae23-f4872995d773 0299-3674 HUMAN OTC DRUG Benzac salicylic acid SOLUTION TOPICAL 20141201 OTC MONOGRAPH FINAL part333D Galderma Laboratories, L.P. SALICYLIC ACID .5 g/100mL N 20181231 0299-3674_dd2e8d7d-577b-42f9-b9b6-81a6c29dc7a6 0299-3674 HUMAN OTC DRUG Benzac salicylic acid SOLUTION TOPICAL 20141201 OTC MONOGRAPH FINAL part333D Galderma Laboratories, L.P. SALICYLIC ACID .5 g/100mL N 20181231 0299-3676_d2ab037d-1d51-4986-b7c5-a83c4c1afa1c 0299-3676 HUMAN OTC DRUG Benzac salicylic acid SOLUTION TOPICAL 20141201 OTC MONOGRAPH FINAL part333D Galderma Laboratories, L.P. SALICYLIC ACID .5 g/100mL N 20181231 0299-3677_a2b9514c-c8bc-43e1-8b79-579c6a6f3564 0299-3677 HUMAN OTC DRUG Benzac salicylic acid GEL TOPICAL 20141201 OTC MONOGRAPH FINAL part333D Galderma Laboratories, L.P. SALICYLIC ACID 2 g/100mL E 20171231 0299-3820_578810bb-a90d-43bd-8c02-c33bdcfea68a 0299-3820 HUMAN PRESCRIPTION DRUG METROGEL metronidazole GEL TOPICAL 20050630 NDA NDA021789 Galderma Laboratories, L.P. METRONIDAZOLE 10 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0299-3822_d1637d68-359d-4eed-8dee-729f7510eb50 0299-3822 HUMAN PRESCRIPTION DRUG ORACEA DOXYCYCLINE CAPSULE ORAL 20100514 NDA NDA050805 Galderma Laboratories, L.P. DOXYCYCLINE 40 mg/1 N 20181231 0299-3823_1b84f32e-fdd7-40f2-b762-b8730bee5b0e 0299-3823 HUMAN PRESCRIPTION DRUG SOOLANTRA IVERMECTIN CREAM TOPICAL 20150101 NDA NDA206255 Galderma Laboratories, L.P. IVERMECTIN 10 mg/g Antiparasitic [EPC],Pediculicide [EPC] N 20181231 0299-3836_a7ef3281-ba9c-874b-2021-635ffaf17776 0299-3836 HUMAN PRESCRIPTION DRUG MetroCream metronidazole CREAM TOPICAL 19950920 NDA NDA020531 Galderma Laboratories, L.P. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0299-3838_9fcf46d2-0e58-4e43-94fa-9937a920c2c5 0299-3838 HUMAN PRESCRIPTION DRUG MetroLotion metronidazole LOTION TOPICAL 19981124 NDA NDA020901 Galderma Laboratories, L.P. METRONIDAZOLE 7.5 mg/mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0299-3839_81928d4c-2ee7-4313-aa7a-2a228abcdd51 0299-3839 HUMAN PRESCRIPTION DRUG Rosanil sodium sulfacetamide, sulfer SOLUTION TOPICAL 20030131 UNAPPROVED DRUG OTHER Galderma Laboratories, L.P. SULFACETAMIDE; SULFUR 10; 5 g/100g; g/100g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0299-3847_5fe51e0d-1e86-49ce-855b-10bb75b91c45 0299-3847 HUMAN PRESCRIPTION DRUG Clobex clobetasol propionate SHAMPOO TOPICAL 20040301 NDA NDA021644 Galderma Laboratories, L.P. CLOBETASOL PROPIONATE .05 g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0299-3848_9b1b5e9d-ff0c-4ab0-bddc-e339655af9db 0299-3848 HUMAN PRESCRIPTION DRUG Clobex Clobetasol Propionate LOTION TOPICAL 20030801 NDA NDA021535 Galderma Laboratories, L.P. CLOBETASOL PROPIONATE .05 g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0299-3849_1433356b-8522-4fb2-892d-52b6137e1fde 0299-3849 HUMAN PRESCRIPTION DRUG CLOBEX clobetasol propionate SPRAY TOPICAL 20051027 NDA NDA021835 Galderma Laboratories, L.P. CLOBETASOL PROPIONATE .05 g/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0299-3913_28564abb-8116-493e-9ce2-7de7522d8c9b 0299-3913 HUMAN OTC DRUG Cetaphil DermaControl SPF 30 octocrylene, octisalate, avobenzone LOTION TOPICAL 20111201 OTC MONOGRAPH FINAL part352 Galderma Laboratories, L.P. OCTOCRYLENE; OCTISALATE; AVOBENZONE 7; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 0299-3925_e348d112-9e6f-4f68-93c3-f728ce595558 0299-3925 HUMAN OTC DRUG Cetaphil Gentle Cleansing Antibacterial Bar triclosan SOAP TOPICAL 20120101 20190531 OTC MONOGRAPH NOT FINAL part333A Galderma Laboratories, L.P. TRICLOSAN .3 g/100g N 20181231 0299-3928_ba344c9c-ea52-49f0-af0d-202da47e0018 0299-3928 HUMAN OTC DRUG Cetaphil octocrylene, avobenzone LOTION TOPICAL 20000401 OTC MONOGRAPH FINAL part352 Galderma Laboratories, L.P. OCTOCRYLENE; AVOBENZONE 10; 3 g/100mL; g/100mL N 20181231 0299-4606_4545c44f-0164-4441-9976-754297dac3f7 0299-4606 HUMAN OTC DRUG Differin Daily Deep Cleanser with BPO benzoyl peroxide SOLUTION TOPICAL 20171101 OTC MONOGRAPH FINAL part333D Galderma Laboratories, L.P. BENZOYL PEROXIDE 5 g/100mL N 20181231 0299-4805_6a94ae28-43cc-4def-868a-b0549d95ae64 0299-4805 HUMAN OTC DRUG Qilib Hair Regrowth Treatment for Men MINOXIDIL SOLUTION TOPICAL 20151201 NDA NDA020834 Galderma Laboratories, L.P. MINOXIDIL 5 g/100mL N 20181231 0299-4820_0a24cdda-f77f-416b-94f0-a9347ed2a7e3 0299-4820 HUMAN OTC DRUG Qilib Hair Regrowth Treatment for Women MINOXIDIL SOLUTION TOPICAL 20151201 NDA NDA020834 Galderma Laboratories, L.P. MINOXIDIL 2 g/100mL N 20181231 0299-4910_6aa14517-c223-449b-830c-e738085080ff 0299-4910 HUMAN OTC DRUG Differin Adapalene GEL TOPICAL 20160708 NDA NDA020380 Galderma Laboratories, L.P. ADAPALENE 1 mg/g N 20181231 0299-4913_6dec9a7d-7dc2-4939-a4cc-4da888e02f7c 0299-4913 HUMAN OTC DRUG Differin Oil Control Moisturizer SPF 30 octocrylene, octisalate, avobenzone LOTION TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Galderma Laboratories, L.P. OCTOCRYLENE; OCTISALATE; AVOBENZONE 7; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 0299-4925_e38a6cfd-5a67-4b94-9c64-d678aa00c776 0299-4925 HUMAN OTC DRUG Cetaphil Purifying Facial Bar triclosan SOAP TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Galderma Laboratories, L.P. TRICLOSAN .3 g/100g N 20181231 0299-4930_bf6ced0f-6062-453c-b024-9c8a3aadc5e1 0299-4930 HUMAN OTC DRUG Cetaphil Daily Facial Moisturizer with suncreen SPF 50 octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part352 Galderma Laboratories, L.P. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 75; 50; 70; 60; 57 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0299-5500_0239a654-1e47-4d37-adfa-b8167a958870 0299-5500 HUMAN PRESCRIPTION DRUG Capex fluocinolone acetonide KIT 19841012 NDA NDA020001 Galderma Laboratories, L.P. N 20181231 0299-5765_b0a573ea-853c-4a47-9863-b3bedb6f41cf 0299-5765 HUMAN PRESCRIPTION DRUG DesOwen desonide LOTION TOPICAL 19880715 ANDA ANDA072354 Galderma Laboratories, L.P. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0299-5770_b0a573ea-853c-4a47-9863-b3bedb6f41cf 0299-5770 HUMAN PRESCRIPTION DRUG DesOwen desonide CREAM TOPICAL 19841214 NDA NDA019048 Galderma Laboratories, L.P. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0299-5889_7c2f058a-4af1-4403-8fbe-3b57ee275c4b 0299-5889 HUMAN OTC DRUG Cetaphil Redness Relieving Daily Facial Moisturizer with suncreen SPF 20 titanium dioxide, zinc oxide CREAM TOPICAL 20161209 OTC MONOGRAPH FINAL part352 Galderma Laboratories, L.P. TITANIUM DIOXIDE; ZINC OXIDE 101; 78 mg/mL; mg/mL N 20181231 0299-5906_aba77388-eedc-4628-8dcf-5a854b189217 0299-5906 HUMAN PRESCRIPTION DRUG epiduo forte adapalene and benzoyl peroxide GEL TOPICAL 20150701 NDA NDA207917 Galderma Laboratories, L.P. ADAPALENE; BENZOYL PEROXIDE 3; 25 mg/g; mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0299-5908_a6dfb647-2bbe-40f6-a06c-2b0815cb8057 0299-5908 HUMAN PRESCRIPTION DRUG EPIDUO adapalene and benzoyl peroxide GEL TOPICAL 20081208 NDA NDA022320 Galderma Laboratories, L.P. ADAPALENE; BENZOYL PEROXIDE 1; 25 mg/g; mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0299-5910_79d4f186-a6fc-4fe5-9ca6-246c32317efd 0299-5910 HUMAN PRESCRIPTION DRUG DIFFERIN adapalene GEL TOPICAL 19960531 NDA NDA020380 Galderma Laboratories, L.P. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0299-5912_4e1b23c2-deab-4dff-864f-14b125fe15fd 0299-5912 HUMAN PRESCRIPTION DRUG Differin adapalene LOTION TOPICAL 20100331 NDA NDA022502 Galderma Laboratories, L.P. ADAPALENE .1 g/100mL Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0299-5915_2b7d3489-0210-4e9b-95b7-dc0f6223b2f1 0299-5915 HUMAN PRESCRIPTION DRUG Differin Adapalene CREAM TOPICAL 20091124 NDA NDA020748 GALDERMA LABORATORIES, L.P ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0299-5918_48887fea-27f4-4dc7-980b-cf80011f6675 0299-5918 HUMAN PRESCRIPTION DRUG DIFFERIN adapalene GEL TOPICAL 20090915 NDA NDA021753 Galderma Laboratories, L.P. ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0299-5950_a3841975-609a-af4d-e8ca-e5880cfc7929 0299-5950 HUMAN PRESCRIPTION DRUG TRI-LUMA fluocinolone acetonide, hydroquinone, and tretinoin CREAM TOPICAL 20020118 NDA NDA021112 Galderma Laboratories, L.P. FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN .1; 40; .5 mg/g; mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0299-5962_90b85e82-3a1e-4487-981a-ab7e09519a2e 0299-5962 HUMAN PRESCRIPTION DRUG Dysport Botulinum Toxin Type A INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20091102 BLA BLA125274 Galderma Laboratories, L.P. BOTULINUM TOXIN TYPE A 300 U/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 0299-5980_2c78b1f4-5ebf-4e6f-8b3d-c4d2dc6546e2 0299-5980 HUMAN PRESCRIPTION DRUG Mirvaso brimonidine tartrate GEL TOPICAL 20130823 NDA NDA204708 Galderma Laboratories, L.P. BRIMONIDINE TARTRATE 5 mg/g Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0299-6100_20237304-10de-4a50-92d9-c073c14a6568 0299-6100 HUMAN PRESCRIPTION DRUG PLIAGLIS lidocaine and tetracaine CREAM TOPICAL 20060629 NDA NDA021717 Galderma Laboratories, L.P. LIDOCAINE; TETRACAINE 70; 70 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 0310-0088_3f473e07-8a22-44d0-a457-e06131d63114 0310-0088 HUMAN PRESCRIPTION DRUG Daliresp roflumilast TABLET ORAL 20150701 NDA NDA022522 AstraZeneca Pharmaceuticals LP ROFLUMILAST 250 ug/1 Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA] N 20191231 0310-0095_3f473e07-8a22-44d0-a457-e06131d63114 0310-0095 HUMAN PRESCRIPTION DRUG Daliresp roflumilast TABLET ORAL 20150701 NDA NDA022522 AstraZeneca Pharmaceuticals LP ROFLUMILAST 500 ug/1 Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA] N 20191231 0310-0101_3482bde0-7aa5-4c0e-b0c0-f1e3d0445238 0310-0101 HUMAN PRESCRIPTION DRUG TENORMIN Atenolol TABLET ORAL 19900901 20180630 NDA NDA018240 AstraZeneca Pharmaceuticals LP ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0310-0105_3482bde0-7aa5-4c0e-b0c0-f1e3d0445238 0310-0105 HUMAN PRESCRIPTION DRUG TENORMIN Atenolol TABLET ORAL 19900901 20180630 NDA NDA018240 AstraZeneca Pharmaceuticals LP ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0310-0107_3482bde0-7aa5-4c0e-b0c0-f1e3d0445238 0310-0107 HUMAN PRESCRIPTION DRUG TENORMIN Atenolol TABLET ORAL 19910201 20180930 NDA NDA018240 AstraZeneca Pharmaceuticals LP ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0310-0115_0872728d-4d39-4413-a179-ac074dcbbde3 0310-0115 HUMAN PRESCRIPTION DRUG TENORETIC Atenolol and Chlorthalidone TABLET ORAL 19900901 20180930 NDA NDA018760 AstraZeneca Pharmaceuticals LP ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0310-0117_0872728d-4d39-4413-a179-ac074dcbbde3 0310-0117 HUMAN PRESCRIPTION DRUG TENORETIC Atenolol and Chlorthalidone TABLET ORAL 19900901 20180531 NDA NDA018760 AstraZeneca Pharmaceuticals LP ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0310-0130_64631ead-dc8c-44ff-a223-e4d3eb42c459 0310-0130 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20091111 20181031 NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0310-0131_64631ead-dc8c-44ff-a223-e4d3eb42c459 0310-0131 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20090828 20180331 NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0310-0132_64631ead-dc8c-44ff-a223-e4d3eb42c459 0310-0132 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20090513 20180531 NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0310-0133_64631ead-dc8c-44ff-a223-e4d3eb42c459 0310-0133 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20100922 20181031 NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0310-0134_64631ead-dc8c-44ff-a223-e4d3eb42c459 0310-0134 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20100326 20181031 NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0310-0135_64631ead-dc8c-44ff-a223-e4d3eb42c459 0310-0135 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20110902 20180430 NDA NDA019777 AstraZeneca Pharmaceuticals LP LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0310-0142_28321998-49dc-4d8c-af40-effd3e4dbbfe 0310-0142 HUMAN PRESCRIPTION DRUG ZESTORETIC Lisinopril and Hydrochlorothiazide TABLET ORAL 20110509 20180531 NDA NDA019888 AstraZeneca Pharmaceuticals LP LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0310-0201_53e8c8ac-8aed-43fc-84f4-437dafae6c0d 0310-0201 HUMAN PRESCRIPTION DRUG ARIMIDEX Anastrozole TABLET ORAL 19960116 NDA NDA020541 AstraZeneca Pharmaceuticals LP ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0310-0271_f43fa27f-03ac-4756-8ae4-2693beeefb74 0310-0271 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-0272_f43fa27f-03ac-4756-8ae4-2693beeefb74 0310-0272 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-0274_f43fa27f-03ac-4756-8ae4-2693beeefb74 0310-0274 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20001113 NDA NDA020639 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-0275_f43fa27f-03ac-4756-8ae4-2693beeefb74 0310-0275 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-0278_f43fa27f-03ac-4756-8ae4-2693beeefb74 0310-0278 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20060213 NDA NDA020639 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-0279_f43fa27f-03ac-4756-8ae4-2693beeefb74 0310-0279 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20060213 NDA NDA020639 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-0280_02bb1367-177e-43a2-b5c6-b8acf882faa7 0310-0280 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20090201 NDA NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-0281_02bb1367-177e-43a2-b5c6-b8acf882faa7 0310-0281 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20090201 NDA NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-0282_02bb1367-177e-43a2-b5c6-b8acf882faa7 0310-0282 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20070716 NDA NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-0283_02bb1367-177e-43a2-b5c6-b8acf882faa7 0310-0283 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20070716 NDA NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-0284_02bb1367-177e-43a2-b5c6-b8acf882faa7 0310-0284 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20070716 NDA NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-0297_02bb1367-177e-43a2-b5c6-b8acf882faa7 0310-0297 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate KIT 20141002 NDA NDA022047 AstraZeneca Pharmaceuticals LP N 20181231 0310-0321_f11de23c-4713-4b8a-bce2-b6433b5d2482 0310-0321 HUMAN PRESCRIPTION DRUG MERREM IV Meropenem INJECTION INTRAVENOUS 19960923 NDA NDA050706 AstraZeneca Pharmaceuticals LP MEROPENEM 1 g/30mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20191231 0310-0325_f11de23c-4713-4b8a-bce2-b6433b5d2482 0310-0325 HUMAN PRESCRIPTION DRUG MERREM IV Meropenem INJECTION INTRAVENOUS 19960923 NDA NDA050706 AstraZeneca Pharmaceuticals LP MEROPENEM 500 mg/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20191231 0310-0411_705f58d2-a75f-4683-9546-352a5a297e42 0310-0411 HUMAN PRESCRIPTION DRUG ZAFIRLUKAST Zafirlukast TABLET, FILM COATED ORAL 20101119 20180430 NDA NDA020547 AstraZeneca Pharmaceuticals LP ZAFIRLUKAST 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0310-0412_705f58d2-a75f-4683-9546-352a5a297e42 0310-0412 HUMAN PRESCRIPTION DRUG ZAFIRLUKAST Zafirlukast TABLET, FILM COATED ORAL 20101119 20180930 NDA NDA020547 AstraZeneca Pharmaceuticals LP ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0310-0482_a2e9ea1a-f971-4c2b-addf-6791af0041e2 0310-0482 HUMAN PRESCRIPTION DRUG IRESSA Gefitinib TABLET, COATED ORAL 20150713 NDA NDA206995 AstraZeneca Pharmaceuticals LP GEFITINIB 250 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 0310-0512_4ae431dc-560c-4df3-bc0c-91dce35038a3 0310-0512 HUMAN PRESCRIPTION DRUG CALQUENCE Acalabrutinib CAPSULE, GELATIN COATED ORAL 20171031 NDA NDA210259 AstraZeneca Pharmaceuticals LP ACALABRUTINIB 100 mg/1 Kinase Inhibitor [EPC],Tyrosine Kinase Inhibitors [MoA] N 20191231 0310-0657_2586bfb2-e1a6-41f2-b3ee-f78320a5c6fa 0310-0657 HUMAN PRESCRIPTION DRUG Lynparza olaparib CAPSULE ORAL 20141224 NDA NDA206162 AstraZeneca Pharmaceuticals LP OLAPARIB 50 mg/1 Poly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA] N 20181231 0310-0668_430eddde-a3e7-4ef1-8891-5c662302d931 0310-0668 HUMAN PRESCRIPTION DRUG Lynparza olaparib TABLET, FILM COATED ORAL 20170817 NDA NDA208558 AstraZeneca Pharmaceuticals LP OLAPARIB 100 mg/1 Poly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA] N 20191231 0310-0679_430eddde-a3e7-4ef1-8891-5c662302d931 0310-0679 HUMAN PRESCRIPTION DRUG Lynparza olaparib TABLET, FILM COATED ORAL 20170817 NDA NDA208558 AstraZeneca Pharmaceuticals LP OLAPARIB 150 mg/1 Poly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA] N 20191231 0310-0705_36400ad4-ad78-4ba2-a828-e15237464b3a 0310-0705 HUMAN PRESCRIPTION DRUG CASODEX Bicalutamide TABLET ORAL 19951016 NDA NDA020498 AstraZeneca Pharmaceuticals LP BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 0310-0720_c45373c4-66bf-457b-84b9-ca72bb6d9467 0310-0720 HUMAN PRESCRIPTION DRUG FASLODEX Fulvestrant INJECTION INTRAMUSCULAR 20101101 NDA NDA021344 AstraZeneca Pharmaceuticals LP FULVESTRANT 50 mg/mL Estrogen Receptor Antagonist [EPC],Estrogen Receptor Antagonists [MoA],Selective Estrogen Receptor Modulators [MoA] N 20181231 0310-0751_dad86292-3090-4ed2-98e0-244b0c0b0ea9 0310-0751 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 AstraZeneca Pharmaceuticals LP ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0310-0752_dad86292-3090-4ed2-98e0-244b0c0b0ea9 0310-0752 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 AstraZeneca Pharmaceuticals LP ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0310-0754_dad86292-3090-4ed2-98e0-244b0c0b0ea9 0310-0754 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 AstraZeneca Pharmaceuticals LP ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0310-0755_dad86292-3090-4ed2-98e0-244b0c0b0ea9 0310-0755 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 AstraZeneca Pharmaceuticals LP ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0310-0800_b0423fc4-a73b-4542-9792-2e5fc54ae6ce 0310-0800 HUMAN PRESCRIPTION DRUG Tudorza Pressair aclidinium bromide INHALANT RESPIRATORY (INHALATION) 20150701 NDA NDA202450 AstraZeneca Pharmaceuticals LP ACLIDINIUM BROMIDE 400 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0310-0950_aa22eb64-3073-4975-b10b-786e82961b7b 0310-0950 HUMAN PRESCRIPTION DRUG ZOLADEX Goserelin acetate IMPLANT SUBCUTANEOUS 20030505 NDA NDA019726 AstraZeneca Pharmaceuticals LP GOSERELIN ACETATE 3.6 mg/1 Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] N 20181231 0310-0951_c1fad177-653c-43ef-a3ad-44f4cc207a77 0310-0951 HUMAN PRESCRIPTION DRUG ZOLADEX Goserelin acetate IMPLANT SUBCUTANEOUS 20030505 NDA NDA020578 AstraZeneca Pharmaceuticals LP GOSERELIN ACETATE 10.8 mg/1 Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] N 20181231 0310-1097_81576f3e-10bd-4d55-b42d-9ecf1e1e4914 0310-1097 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET, FILM COATED ORAL 20111230 NDA NDA021956 AstraZeneca Pharmaceuticals LP METOPROLOL SUCCINATE; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0310-1349_d996494b-c0bc-42f2-9ecd-0b5216edc6f0 0310-1349 HUMAN PRESCRIPTION DRUG TAGRISSO osimertinib TABLET, FILM COATED ORAL 20151113 NDA NDA208065 AstraZeneca Pharmaceuticals LP OSIMERTINIB 40 1/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 0310-1350_d996494b-c0bc-42f2-9ecd-0b5216edc6f0 0310-1350 HUMAN PRESCRIPTION DRUG TAGRISSO osimertinib TABLET, FILM COATED ORAL 20151113 NDA NDA208065 AstraZeneca Pharmaceuticals LP OSIMERTINIB 80 1/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 0310-1475_fbdd2500-f1bb-488b-8cfa-fc16148771d3 0310-1475 HUMAN PRESCRIPTION DRUG ZURAMPIC lesinurad TABLET, FILM COATED ORAL 20160811 NDA NDA207988 AstraZeneca Pharmaceuticals LP LESINURAD 200 mg/1 Urate Transporter 1 Inhibitor [EPC],Urate Transporter 1 Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA] N 20181231 0310-1730_f0355a0d-6a94-4b16-9408-632468505b60 0310-1730 HUMAN PRESCRIPTION DRUG FASENRA Benralizumab INJECTION, SOLUTION SUBCUTANEOUS 20171114 BLA BLA761070 AstraZeneca Pharmaceuticals LP BENRALIZUMAB 30 mg/mL N 20181231 0310-1969_8469faae-0022-45a8-8d3a-7c23603788ac 0310-1969 HUMAN PRESCRIPTION DRUG MOVANTIK naloxegol oxalate TABLET, FILM COATED ORAL 20150306 NDA NDA204760 AstraZeneca Pharmaceuticals LP NALOXEGOL OXALATE 12.5 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 0310-1970_8469faae-0022-45a8-8d3a-7c23603788ac 0310-1970 HUMAN PRESCRIPTION DRUG MOVANTIK naloxegol oxalate TABLET, FILM COATED ORAL 20150306 NDA NDA204760 AstraZeneca Pharmaceuticals LP NALOXEGOL OXALATE 25 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 0310-4500_8baba4ea-2855-42fa-9bd9-5a7548d4cec3 0310-4500 HUMAN PRESCRIPTION DRUG IMFINZI Durvalumab INJECTION, SOLUTION INTRAVENOUS 20170501 BLA BLA761069 AstraZeneca Pharmaceuticals LP DURVALUMAB 120 mg/2.4mL Programmed Death Ligand-1 Blocker [EPC],Programmed Death Ligand-1 Antagonists [MoA],Programmed Death Ligand-1-directed Antibody Interactions [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 0310-4600_8acbfd94-8b5a-415b-9b84-66baad273763 0310-4600 HUMAN PRESCRIPTION DRUG BEVESPI AEROSPHERE Glycopyrrolate and formoterol fumarate AEROSOL, METERED RESPIRATORY (INHALATION) 20161003 NDA NDA208294 AstraZeneca Pharmaceuticals LP GLYCOPYRROLATE; FORMOTEROL FUMARATE 9; 4.8 ug/1; ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0310-4611_8baba4ea-2855-42fa-9bd9-5a7548d4cec3 0310-4611 HUMAN PRESCRIPTION DRUG IMFINZI Durvalumab INJECTION, SOLUTION INTRAVENOUS 20170501 BLA BLA761069 AstraZeneca Pharmaceuticals LP DURVALUMAB 500 mg/10mL Programmed Death Ligand-1 Blocker [EPC],Programmed Death Ligand-1 Antagonists [MoA],Programmed Death Ligand-1-directed Antibody Interactions [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 0310-6100_38b7ae08-470b-4026-9830-9e8ba8006574 0310-6100 HUMAN PRESCRIPTION DRUG ONGLYZA SAXAGLIPTIN TABLET, FILM COATED ORAL 20141120 NDA NDA022350 AstraZeneca Pharmaceuticals LP SAXAGLIPTIN HYDROCHLORIDE 2.5 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 0310-6105_38b7ae08-470b-4026-9830-9e8ba8006574 0310-6105 HUMAN PRESCRIPTION DRUG ONGLYZA SAXAGLIPTIN TABLET, FILM COATED ORAL 20141120 NDA NDA022350 AstraZeneca Pharmaceuticals LP SAXAGLIPTIN HYDROCHLORIDE 5 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 0310-6125_fca43d4e-0c0e-4956-8c82-b44671beb183 0310-6125 HUMAN PRESCRIPTION DRUG KOMBIGLYZE XR SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141204 NDA NDA200678 AstraZeneca Pharmaceuticals LP SAXAGLIPTIN HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 2.5; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0310-6135_fca43d4e-0c0e-4956-8c82-b44671beb183 0310-6135 HUMAN PRESCRIPTION DRUG KOMBIGLYZE XR SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141204 NDA NDA200678 AstraZeneca Pharmaceuticals LP SAXAGLIPTIN HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0310-6145_fca43d4e-0c0e-4956-8c82-b44671beb183 0310-6145 HUMAN PRESCRIPTION DRUG KOMBIGLYZE XR SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141204 NDA NDA200678 AstraZeneca Pharmaceuticals LP SAXAGLIPTIN HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 5; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0310-6205_0dbbd015-9be3-4ea9-86d9-1cc6c79521d3 0310-6205 HUMAN PRESCRIPTION DRUG FARXIGA DAPAGLIFLOZIN TABLET, FILM COATED ORAL 20080114 NDA NDA202293 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL 5 mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] N 20181231 0310-6210_0dbbd015-9be3-4ea9-86d9-1cc6c79521d3 0310-6210 HUMAN PRESCRIPTION DRUG FARXIGA DAPAGLIFLOZIN TABLET, FILM COATED ORAL 20080114 NDA NDA202293 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL 10 mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] N 20181231 0310-6225_2157a8f0-695e-4159-9919-99d7d1c8a3cf 0310-6225 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141029 NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 2.5; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0310-6250_2157a8f0-695e-4159-9919-99d7d1c8a3cf 0310-6250 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141029 NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0310-6260_2157a8f0-695e-4159-9919-99d7d1c8a3cf 0310-6260 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141029 NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 5; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0310-6270_2157a8f0-695e-4159-9919-99d7d1c8a3cf 0310-6270 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141029 NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 10; 500 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0310-6280_2157a8f0-695e-4159-9919-99d7d1c8a3cf 0310-6280 HUMAN PRESCRIPTION DRUG XIGDUO XR dapagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141029 NDA NDA205649 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN PROPANEDIOL; METFORMIN HYDROCHLORIDE 10; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0310-6512_c96da551-956f-41cf-bba5-c3d4e9bae6d8 0310-6512 HUMAN PRESCRIPTION DRUG Byetta exenatide INJECTION SUBCUTANEOUS 20141210 NDA NDA021773 AstraZeneca Pharmaceuticals LP EXENATIDE 250 ug/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20181231 0310-6520_c5d95af9-9f58-4914-8863-0edb666e39a2 0310-6520 HUMAN PRESCRIPTION DRUG BYDUREON exenatide KIT 20150201 NDA NDA022200 AstraZeneca Pharmaceuticals LP N 20181231 0310-6524_c96da551-956f-41cf-bba5-c3d4e9bae6d8 0310-6524 HUMAN PRESCRIPTION DRUG Byetta exenatide INJECTION SUBCUTANEOUS 20141212 NDA NDA021773 AstraZeneca Pharmaceuticals LP EXENATIDE 250 ug/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20181231 0310-6530_c5d95af9-9f58-4914-8863-0edb666e39a2 0310-6530 HUMAN PRESCRIPTION DRUG BYDUREON exenatide INJECTION, SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 20140908 NDA NDA022200 AstraZeneca Pharmaceuticals LP EXENATIDE 2 mg/.65mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20181231 0310-6540_3a9c8687-7a62-4e7b-872f-8ae1cb992fd7 0310-6540 HUMAN PRESCRIPTION DRUG BYDUREON BCise exenatide INJECTION, SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 20171201 NDA NDA209210 AstraZeneca Pharmaceuticals LP EXENATIDE 2 mg/.85mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] N 20181231 0310-6615_311dc8bf-5581-4ac4-9edd-7d4a16597dd4 0310-6615 HUMAN PRESCRIPTION DRUG SymlinPen pramlintide acetate INJECTION SUBCUTANEOUS 20150108 NDA NDA021332 AstraZeneca Pharmaceuticals LP PRAMLINTIDE ACETATE 1000 ug/mL Amylin Agonists [MoA],Amylin Analog [EPC] N 20181231 0310-6627_311dc8bf-5581-4ac4-9edd-7d4a16597dd4 0310-6627 HUMAN PRESCRIPTION DRUG SymlinPen pramlintide acetate INJECTION SUBCUTANEOUS 20150108 NDA NDA021332 AstraZeneca Pharmaceuticals LP PRAMLINTIDE ACETATE 1000 ug/mL Amylin Agonists [MoA],Amylin Analog [EPC] N 20181231 0310-6780_b14ff880-a81c-4589-87c3-2f2550f1645a 0310-6780 HUMAN PRESCRIPTION DRUG QTERN dapagliflozin and saxagliptin TABLET, FILM COATED ORAL 20171204 NDA NDA209091 AstraZeneca Pharmaceuticals LP DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE 10; 5 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 0310-7820_93695e2a-3d45-452d-aa6e-1e14181e56fa 0310-7820 HUMAN PRESCRIPTION DRUG CAPRELSA Vandetanib TABLET ORAL 20110725 NDA NDA022405 AstraZeneca Pharmaceuticals LP VANDETANIB 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0310-7840_93695e2a-3d45-452d-aa6e-1e14181e56fa 0310-7840 HUMAN PRESCRIPTION DRUG CAPRELSA Vandetanib TABLET ORAL 20110725 NDA NDA022405 AstraZeneca Pharmaceuticals LP VANDETANIB 300 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0310-8280_7283b14f-023d-466f-a7eb-4356803d7c65 0310-8280 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended Release Quetiapine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170501 NDA AUTHORIZED GENERIC NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-8281_7283b14f-023d-466f-a7eb-4356803d7c65 0310-8281 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended Release Quetiapine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170501 NDA AUTHORIZED GENERIC NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-8282_7283b14f-023d-466f-a7eb-4356803d7c65 0310-8282 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended Release Quetiapine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170501 NDA AUTHORIZED GENERIC NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-8283_7283b14f-023d-466f-a7eb-4356803d7c65 0310-8283 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended Release Quetiapine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170501 NDA AUTHORIZED GENERIC NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 0310-8284_7283b14f-023d-466f-a7eb-4356803d7c65 0310-8284 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended Release Quetiapine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170501 NDA AUTHORIZED GENERIC NDA022047 AstraZeneca Pharmaceuticals LP QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 0311-0585_acf2f8d5-3582-4601-9ceb-dee438023b29 0311-0585 HUMAN OTC DRUG Almay Sensitive Skin Antiperspirant - Deodorant Roll-On Fragrance Free ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Almay, Inc ALUMINUM SESQUICHLOROHYDRATE .25 g/mL E 20171231 0311-0700_442d718f-ec7d-63af-e054-00144ff88e88 0311-0700 HUMAN OTC DRUG Almay Line Smoothing Liquid Make-Up for Dry Skin Titanium Dioxide Zinc Oxide LIQUID TOPICAL 20090709 OTC MONOGRAPH FINAL part352 Almay, Inc. TITANIUM DIOXIDE; ZINC OXIDE 4.7; 2.1 mg/mL; mg/mL N 20181231 0311-0701_438f6b9e-8ca2-0637-e054-00144ff88e88 0311-0701 HUMAN OTC DRUG Almay Smart Shade Skintone Matching Makeup Titanium Dioxide Zinc Oxide LIQUID TOPICAL 20160416 OTC MONOGRAPH FINAL part352 Almay, Inc. TITANIUM DIOXIDE; ZINC OXIDE 4.8; 2.4 mg/mL; mg/mL N 20181231 0311-0702_4406455a-4914-2bb9-e054-00144ff8d46c 0311-0702 HUMAN OTC DRUG Almay Smart Shade Skintone Anti- Aging Make-Up Titanium Dioxide Zinc Oxide LIQUID TOPICAL 20131114 OTC MONOGRAPH FINAL part352 Almay, Inc. ZINC OXIDE; TITANIUM DIOXIDE 2; 3.9 mg/mL; mg/mL N 20181231 0311-0703_4431d18a-a361-0d68-e054-00144ff88e88 0311-0703 HUMAN OTC DRUG Almay Smart Shade Smart Balance Make-Up Titanium Dioxide Zinc Oxide LIQUID TOPICAL 20090420 OTC MONOGRAPH FINAL part352 Almay, Inc. TITANIUM DIOXIDE; ZINC OXIDE 3.8; 2 mg/mL; mg/mL N 20181231 0311-0704_44071c8d-ea8f-23f8-e054-00144ff88e88 0311-0704 HUMAN OTC DRUG Almay Wake-Up Liquid Make-Up Titanium Dioxide, Oxctinoxate LIQUID TOPICAL 20130423 OTC MONOGRAPH FINAL part352 Almay, Inc. OCTINOXATE; TITANIUM DIOXIDE 3.5; 9 mg/mL; mg/mL N 20181231 0311-0705_42ebec63-11fc-3fd6-e054-00144ff8d46c 0311-0705 HUMAN OTC DRUG Almay Smart Shade CC Cream Octinoxate, Octisalate, Titanium Dioxide Make-Up LIQUID TOPICAL 20130422 OTC MONOGRAPH FINAL part352 Almay OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 5; 5.1 mg/mL; mg/mL; mg/mL N 20181231 0311-0706_42ebec63-11e7-3fd6-e054-00144ff8d46c 0311-0706 HUMAN OTC DRUG Almay Age Smart Shade CC Luminous Primer SPF 15 Zinc Oxide, Titanium Dioxide Make-Up LIQUID TOPICAL 20131114 OTC MONOGRAPH FINAL part352 Almay, Inc. ZINC OXIDE; TITANIUM DIOXIDE 3.3; 4.3 mg/mL; mg/mL N 20181231 0311-0707_42b3d1ef-3ce4-0b87-e054-00144ff8d46c 0311-0707 HUMAN OTC DRUG Almay Age Essentials Makeup SPF 15 Octinoxate, Titanium Dioxide Make-Up LIQUID TOPICAL 20160418 OTC MONOGRAPH FINAL part352 Almay, Inc. OCTINOXATE; TITANIUM DIOXIDE 3.5; 4.3 mg/mL; mg/mL N 20181231 0311-0708_437c7408-d5db-1e1e-e054-00144ff88e88 0311-0708 HUMAN OTC DRUG Almay Age Essentials Concealer SPF 20 Octinoxate Zinc Oxide LIQUID TOPICAL 20160416 OTC MONOGRAPH FINAL part352 Almay, Inc. OCTINOXATE; ZINC OXIDE 7.5; 2.4 mg/mL; mg/mL N 20181231 0311-0709_441d389b-d359-33ae-e054-00144ff88e88 0311-0709 HUMAN OTC DRUG Almay Anti Aging Lip Care SPF 20 Octinoxate, Octisalate, Homosalate, Oxybenzone, Avobenzone LIPSTICK TOPICAL 20160420 OTC MONOGRAPH FINAL part352 Almay, Inc. OCTINOXATE; HOMOSALATE; AVOBENZONE; OCTISALATE; OXYBENZONE 7.5; 5; 3; 5; 5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0311-0710_4418b343-f6fa-0212-e054-00144ff8d46c 0311-0710 HUMAN OTC DRUG ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 Titanium Dioxide, Zinc Oxide LIQUID TOPICAL 20160416 OTC MONOGRAPH FINAL part352 Almay, Inc. ZINC OXIDE; TITANIUM DIOXIDE 2.4; 5.5 mg/mL; mg/mL N 20181231 0311-0711_441dcd60-e5dc-4d51-e054-00144ff8d46c 0311-0711 HUMAN OTC DRUG Almay Health Glow 3-In-1 Makeup SPF 20 Octinoxate, Titanium Dioxide, Zinc Oxide KIT TOPICAL 20160120 OTC MONOGRAPH FINAL part352 Almay, Inc. N 20181231 0311-0712_4326c368-eae0-2dcb-e054-00144ff8d46c 0311-0712 HUMAN OTC DRUG Almay Clear Gel ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Almay, Inc. ALUMINUM SESQUICHLOROHYDRATE .25 g/mL N 20181231 0311-0713_4326c368-eae0-2dcb-e054-00144ff8d46c 0311-0713 HUMAN OTC DRUG Almay Clear Gel ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Almay, Inc. ALUMINUM SESQUICHLOROHYDRATE .25 g/mL N 20181231 0311-0714_432989f9-a290-58ef-e054-00144ff88e88 0311-0714 HUMAN OTC DRUG Almay Roll-On For Sensitive Skin - Fragrance-Free ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Almay, Inc. ALUMINUM SESQUICHLOROHYDRATE .25 g/mL N 20181231 0311-0715_442e8091-cbe9-4c61-e054-00144ff8d46c 0311-0715 HUMAN OTC DRUG Almay Clear Complexion Liquid Makeup for Oily Skin Salicylic Acid LIQUID TOPICAL 20070904 OTC MONOGRAPH FINAL part358H Almay, Inc. SALICYLIC ACID .5 mg/mL N 20181231 0311-0717_443111d3-3238-6909-e054-00144ff8d46c 0311-0717 HUMAN OTC DRUG Almay Clear Complexion 4 in 1 Pressed Powder Salicylic Acid POWDER TOPICAL 20140428 OTC MONOGRAPH FINAL part358H Almay, Inc. SALICYLIC ACID .6 mg/mL N 20181231 0311-0718_46ddc252-de75-28af-e054-00144ff8d46c 0311-0718 HUMAN OTC DRUG Almay Clear Complexion Blemish Healing Spot Concealer Salicylic Acid LIQUID TOPICAL 20070904 OTC MONOGRAPH FINAL part358H Almay, Inc. SALICYLIC ACID .01 g/mL N 20181231 0316-0123_6371bf42-b0a0-66ec-e053-2a91aa0a893e 0316-0123 HUMAN PRESCRIPTION DRUG Ala Quin Hydrocortisone and Iodochlorhydroxyquin CREAM TOPICAL 19700819 UNAPPROVED DRUG OTHER Crown Laboratories HYDROCORTISONE; CLIOQUINOL 5; 30 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20191231 0316-0126_63280338-a048-d490-e053-2a91aa0a777f 0316-0126 HUMAN PRESCRIPTION DRUG Alacort Hydrocortisone CREAM TOPICAL 19730309 ANDA ANDA080706 Crown Laboratories HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0316-0128_63280338-a048-d490-e053-2a91aa0a777f 0316-0128 HUMAN PRESCRIPTION DRUG Alacort Hydrocortisone CREAM TOPICAL 20160106 ANDA ANDA080706 Crown Laboratories HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0316-0140_61323da4-f732-4a4b-ae9b-e84db4034d73 0316-0140 HUMAN PRESCRIPTION DRUG Ala Scalp Hydrocortisone Acetate LOTION TOPICAL 19730228 ANDA ANDA083231 Crown Laboratories HYDROCORTISONE ACETATE 20 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0316-0165_59b1f2c8-4eed-3325-e053-2991aa0a087b 0316-0165 HUMAN PRESCRIPTION DRUG TRIDERM Triamcinolone Acetonide CREAM TOPICAL 19840319 ANDA ANDA088042 Crown Laboratories TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0316-0170_59b1f2c8-4eed-3325-e053-2991aa0a087b 0316-0170 HUMAN PRESCRIPTION DRUG TRIDERM Triamcinolone Acetonide CREAM TOPICAL 19840319 ANDA ANDA088042 Crown Laboratories TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0316-0175_59b1f2c8-4eed-3325-e053-2991aa0a087b 0316-0175 HUMAN PRESCRIPTION DRUG TRIDERM Triamcinolone Acetonide CREAM TOPICAL 19840319 ANDA ANDA088042 Crown Laboratories TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0316-0186_6321732f-a99c-5782-e053-2a91aa0a17f1 0316-0186 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19730309 ANDA ANDA080706 Crown Laboratories HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0316-0193_6321732f-a99c-5782-e053-2a91aa0a17f1 0316-0193 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20160106 ANDA ANDA080706 Crown Laboratories HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0316-0221_5b6da858-1ec5-5b34-e053-2991aa0abad5 0316-0221 HUMAN PRESCRIPTION DRUG Nystatin Cream Nystatin Cream CREAM TOPICAL 20171010 ANDA ANDA207733 Crown Laboratories NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0316-0223_6209ae4c-aa31-7a4f-e053-2a91aa0a13cc 0316-0223 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 20180102 ANDA ANDA207730 Crown Laboratories NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0316-0224_6209ae4c-aa31-7a4f-e053-2a91aa0a13cc 0316-0224 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide OINTMENT TOPICAL 20180102 ANDA ANDA207731 Crown Laboratories NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0316-0333_97337af8-87fd-495c-ae18-f4ae1b658aef 0316-0333 HUMAN PRESCRIPTION DRUG Daxbia Cephalexin CAPSULE ORAL 20161226 ANDA ANDA090836 Crown Laboratories, Inc. CEPHALEXIN 333 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0316-1005_eaaf8c06-6aac-4488-a4be-2f8912e30363 0316-1005 HUMAN PRESCRIPTION DRUG Dermasorb HC Complete Kit Hydrocortisone Lotion with Shampoo and Body Wash KIT TOPICAL 20131114 ANDA ANDA083231 Crown Laboratories N 20181231 0316-1015_c6551aee-3d1b-4888-8311-5dc30f21547f 0316-1015 HUMAN PRESCRIPTION DRUG Dermasorb TA Complete Kit Triamcinolone Acetonide Cream with Emollient Cream KIT 20131114 ANDA ANDA088042 Crown Laboratories N 20181231 0316-1035_95e5f86e-897b-4ef9-a514-6b003387f84c 0316-1035 HUMAN PRESCRIPTION DRUG Dermasorb XM Complete Kit Urea Cream with Moisturizing Cream KIT 20131114 UNAPPROVED DRUG OTHER Crown Laboratories N 20181231 0316-2010_637320c6-9c5d-1da5-e053-2991aa0ab6a8 0316-2010 HUMAN OTC DRUG Blue Lizard Regular Sunscreen LOTION TOPICAL 20010415 OTC MONOGRAPH FINAL part352 Crown Laboratories OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 76.5; 20.4; 30.6; 61.2 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 0316-2020_63748917-39d8-7156-e053-2a91aa0a94bc 0316-2020 HUMAN OTC DRUG Blue Lizard Sport Octinoxate, Octocrylene, Oxybenzone, and Zinc Oxide LOTION TOPICAL 20010415 OTC MONOGRAPH FINAL part352 Crown Laboratories OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 76.5; 20.4; 30.6; 61.2 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 0316-2035_6388d374-5828-0c67-e053-2991aa0aa010 0316-2035 HUMAN OTC DRUG Blue Lizard Baby Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20031208 OTC MONOGRAPH FINAL part352 Crown Laboratories TITANIUM DIOXIDE; ZINC OXIDE 54; 108 mg/mL; mg/mL N 20191231 0316-2045_63880f11-aed1-b542-e053-2a91aa0a52ff 0316-2045 HUMAN OTC DRUG Blue Lizard Sensitive Sunscreen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20031208 OTC MONOGRAPH FINAL part352 Crown Laboratories TITANIUM DIOXIDE; ZINC OXIDE 54; 108 mg/mL; mg/mL N 20191231 0316-2055_63858e31-1567-68ed-e053-2991aa0a0b67 0316-2055 HUMAN OTC DRUG Blue Lizard Face Sunscreen GEL TOPICAL 20100406 OTC MONOGRAPH NOT FINAL part352 Crown Laboratories OCTINOXATE; ZINC OXIDE 55; 80 mg/g; mg/g N 20191231 0316-2060_625ba6c8-a067-12c9-e053-2991aa0aad86 0316-2060 HUMAN OTC DRUG Blue Lizard Kids Octinoxate, Octocrylene and Zinc Oxide LOTION TOPICAL 20180102 OTC MONOGRAPH FINAL part352 Crown Laboratories OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 74.3; 20.3; 81.1 mg/mL; mg/mL; mg/mL N 20191231 0316-2070_62959bc6-63ca-9e13-e053-2991aa0a35eb 0316-2070 HUMAN OTC DRUG Blue Lizard Active Octinoxate, Octocrylene and Zinc Oxide LOTION TOPICAL 20180102 OTC MONOGRAPH FINAL part352 Crown Laboratories OCTOCRYLENE; OCTINOXATE; ZINC OXIDE 20.3; 74.3; 81.1 mg/mL; mg/mL; mg/mL N 20191231 0316-7400_b08ed252-9419-4781-ad45-04209f4afaf0 0316-7400 HUMAN PRESCRIPTION DRUG rea lo 40 urea CREAM TOPICAL 20060522 UNAPPROVED DRUG OTHER Crown Laboratories UREA 400 mg/g N 20181231 0316-7401_b08ed252-9419-4781-ad45-04209f4afaf0 0316-7401 HUMAN PRESCRIPTION DRUG rea lo 40 urea LOTION TOPICAL 20060522 UNAPPROVED DRUG OTHER Crown Laboratories UREA 400 mg/mL E 20171231 0322-2222_603e433d-74d2-f542-e053-2991aa0a7148 0322-2222 HUMAN OTC DRUG Percy Medicine Bismuth Subsalicylate LIQUID ORAL 19200101 OTC MONOGRAPH FINAL part335 Merrick Medicine Company, Inc BISMUTH SUBSALICYLATE 1050 mg/10mL N 20181231 0327-0001_1978155e-80a0-479a-8ac3-3c81c0c4ee4a 0327-0001 HUMAN OTC DRUG Clorpactin WCS-90 chlorine POWDER, FOR SOLUTION TOPICAL 19550101 UNAPPROVED DRUG OTHER United-Guardian, Inc. CHLORINE .16 g/2g N 20191231 0327-0011_9fba2d1a-865e-48e6-8eef-8c1c989cc818 0327-0011 HUMAN PRESCRIPTION DRUG Renacidin citric acid, gluconolactone and magnesium carbonate SOLUTION IRRIGATION 19910101 20180601 NDA NDA019481 United-Guardian, Inc. ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE 6.6; .198; 3.376 g/100mL; g/100mL; g/100mL Calculi Dissolution Agent [EPC],Irrigation [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20191231 0327-0012_3c4721a1-66c6-472a-ad22-d7813cb0c74c 0327-0012 HUMAN PRESCRIPTION DRUG Renacidin citric acid, gluconolactone and magnesium carbonate SOLUTION IRRIGATION 20160201 NDA NDA019481 United-Guardian, Inc. ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE 6.602; .198; 3.268 g/100mL; g/100mL; g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Irrigation [MoA] N 20191231 0338-0003_f0f35d75-742d-4ded-a096-edfc66bd4028 0338-0003 HUMAN PRESCRIPTION DRUG Sterile Water Water IRRIGANT IRRIGATION 19800530 NDA NDA017866 Baxter Healthcare Corporation WATER 100 mL/100mL N 20191231 0338-0004_f0f35d75-742d-4ded-a096-edfc66bd4028 0338-0004 HUMAN PRESCRIPTION DRUG Sterile Water Water IRRIGANT IRRIGATION 19741231 NDA NDA017428 Baxter Healthcare Corporation WATER 100 mL/100mL N 20191231 0338-0013_0441455f-a304-468c-98ac-0702fa357ef1 0338-0013 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION, SOLUTION INTRAVENOUS 19820630 NDA NDA018632 Baxter Healthcare Company WATER 100 mL/100mL N 20181231 0338-0013_a170196d-92ed-4441-ae7b-b73af637e8ef 0338-0013 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION, SOLUTION INTRAVENOUS 19820630 NDA NDA018632 Baxter Healthcare Company WATER 100 mL/100mL N 20181231 0338-0017_0156f1bf-166d-4baf-add0-dae41091cb0a 0338-0017 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710304 NDA NDA016673 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 50 g/1000mL N 20191231 0338-0023_0156f1bf-166d-4baf-add0-dae41091cb0a 0338-0023 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710125 NDA NDA016694 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 100 g/1000mL N 20191231 0338-0043_3ef18374-6365-441c-b745-5581b542191b 0338-0043 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018016 Baxter Healthcare Corporation SODIUM CHLORIDE 4.5 g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0047_6ffac585-bc47-4938-aa5c-415cf5283aca 0338-0047 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride IRRIGANT IRRIGATION 19800530 NDA NDA017867 Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0047_9817c893-1714-4daa-87bd-389241d1ec79 0338-0047 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride IRRIGANT IRRIGATION 19800530 NDA NDA017867 Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0048_bbaa6089-9863-4622-9c21-d7ded206e45a 0338-0048 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride IRRIGANT IRRIGATION 19741231 NDA NDA017427 Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0049_3ef18374-6365-441c-b745-5581b542191b 0338-0049 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19701209 NDA NDA016677 Baxter Healthcare Corporation SODIUM CHLORIDE 9 g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0050_0351926d-46d2-4c46-a4ff-22af798b265b 0338-0050 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride SOLUTION EXTRACORPOREAL 19800530 NDA NDA017867 Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0051_b60fc8f8-9df2-461d-9442-c0892b1efea6 0338-0051 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride IRRIGANT IRRIGATION 19850517 NDA NDA019319 Baxter Healthcare Corporation SODIUM CHLORIDE 9 g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0054_2d5e1a51-e687-4c86-b567-2c265db9ab3d 0338-0054 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19831101 NDA NDA019022 Baxter Healthcare Corporation SODIUM CHLORIDE 3 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0056_2d5e1a51-e687-4c86-b567-2c265db9ab3d 0338-0056 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19831101 NDA NDA019022 Baxter Healthcare Corporation SODIUM CHLORIDE 5 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0073_9756fa31-c43d-464e-af99-adee3b5e625a 0338-0073 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016697 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 2.5; 450 g/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0338-0077_9756fa31-c43d-464e-af99-adee3b5e625a 0338-0077 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19701208 NDA NDA016689 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; 200 g/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0338-0081_9756fa31-c43d-464e-af99-adee3b5e625a 0338-0081 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016687 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; 330 g/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0338-0085_9756fa31-c43d-464e-af99-adee3b5e625a 0338-0085 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016683 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; 450 g/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0338-0089_9756fa31-c43d-464e-af99-adee3b5e625a 0338-0089 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride Dextrose and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19701209 NDA NDA016678 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; 900 g/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0338-0104_e56135c4-59d8-41f2-8bec-b4048688aed7 0338-0104 HUMAN PRESCRIPTION DRUG Ringers sodium chloride, calcium chloride, potassium chloride, IRRIGANT IRRIGATION 19820219 NDA NDA018495 Baxter Healthcare Corporation SODIUM CHLORIDE; CALCIUM CHLORIDE; POTASSIUM CHLORIDE 860; 33; 30 mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0105_7c2d5806-0dd7-4d59-b4c3-87b052567d9d 0338-0105 HUMAN PRESCRIPTION DRUG Ringers Sodium Chloride, Calcium Chloride, Potassium Chloride INJECTION INTRAVENOUS 19710322 NDA NDA016693 Baxter Healthcare Corporation SODIUM CHLORIDE; CALCIUM CHLORIDE; POTASSIUM CHLORIDE 8.6; .33; .3 g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0114_f09f80bf-2f8b-4420-865d-aec2d5e5cd4d 0338-0114 HUMAN PRESCRIPTION DRUG Lactated Ringers sodium chloride, sodium lactate, potassium chloride, calcium chloride IRRIGANT IRRIGATION 19820219 NDA NDA018494 Baxter Healthcare Corporation SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE 600; 310; 30; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-0117_ecdd3a36-11ec-4d80-a8fe-d683410c53f1 0338-0117 HUMAN PRESCRIPTION DRUG Lactated Ringers Sodium chloride, potassium chloride, sodium lactate and calcium chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016682 Baxter Healthcare Corporation SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE 600; 310; 30; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20191231 0338-0125_0e6a5be4-405d-4b6a-b1eb-b4ee9ecea115 0338-0125 HUMAN PRESCRIPTION DRUG Lactated Ringers and Dextrose SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016679 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE 5; 600; 310; 30; 20 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-0137_b9ea22af-a4f0-4608-ac21-d9f4d2af60f2 0338-0137 HUMAN PRESCRIPTION DRUG Lactated Ringers sodium chloride, soldium lactate, potassium chloride and calcium chloride IRRIGANT IRRIGATION 19840403 NDA NDA018921 Baxter Healthcare Corporation SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE 6; 3.1; 300; 200 g/1000mL; g/1000mL; mg/1000mL; mg/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20191231 0338-0143_8a050b07-2e24-451f-9b9d-75021e3d1b98 0338-0143 HUMAN PRESCRIPTION DRUG Dextrose and Electrolyte No. 48 Sodium Lactate, Potassium Chloride, Magnesium Chloride, Monobasic Potassium Phosphate, Sodium Chloride and Dextrose monohydrate INJECTION INTRAVENOUS 19790202 NDA NDA017484 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE 5; 260; 141; 31; 20; 12 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0179_7813bdde-6734-4076-bfb5-500a49cd09a8 0338-0179 HUMAN PRESCRIPTION DRUG Plasma-Lyte 148 SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA017378 Baxter Healthcare Corporation SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE 526; 502; 368; 37; 30 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0338-0190_534b85e0-04e7-4652-a948-244b9d382f7d 0338-0190 HUMAN PRESCRIPTION DRUG TIS-U-SOL sodium chloride, potassium chloride, magnesium sulfate, sodium phosphate, and potassium phosphate IRRIGANT IRRIGATION 19820219 NDA NDA018508 Baxter Healthcare Corporation SODIUM CHLORIDE; POTASSIUM CHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; POTASSIUM PHOSPHATE, MONOBASIC 800; 40; 20; 8.75; 6.25 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0221_a538acc8-1a79-4c7b-8d17-e8d8581354ec 0338-0221 HUMAN PRESCRIPTION DRUG Plasma-Lyte A Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnesium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA017378 Baxter Healthcare Corporation SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE 526; 502; 368; 37; 30 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0338-0289_21b4ae8c-c949-4f18-a387-b5121e4fa832 0338-0289 HUMAN PRESCRIPTION DRUG Glycine Glycine SOLUTION IRRIGATION 19800530 NDA NDA017865 Baxter Healthcare Corporation GLYCINE 1.5 g/100mL N 20191231 0338-0295_bf4fdf32-8d9a-45a9-9381-0a9782a6b6b2 0338-0295 HUMAN PRESCRIPTION DRUG Sorbitol Sorbitol IRRIGANT IRRIGATION 19800530 NDA NDA017863 Baxter Healthcare Corporation SORBITOL 30 g/1000mL N 20191231 0338-0341_32d27009-8568-4468-b8cc-7be67d27d783 0338-0341 HUMAN PRESCRIPTION DRUG Cardioplegic Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride SOLUTION INTRA-ARTERIAL 20000421 ANDA ANDA075323 Baxter Healthcare Corporation CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 17.6; 325.3; 119.3; 643 mg/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0351_57c99c24-bbd8-4b9d-b29c-67e2c2d7a049 0338-0351 HUMAN PRESCRIPTION DRUG Osmitrol Mannitol INJECTION, SOLUTION INTRAVENOUS 19640608 NDA NDA013684 Baxter Healthcare Corporation MANNITOL 5 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] N 20181231 0338-0353_57c99c24-bbd8-4b9d-b29c-67e2c2d7a049 0338-0353 HUMAN PRESCRIPTION DRUG Osmitrol Mannitol INJECTION, SOLUTION INTRAVENOUS 19640608 NDA NDA013684 Baxter Healthcare Corporation MANNITOL 10 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] N 20181231 0338-0355_57c99c24-bbd8-4b9d-b29c-67e2c2d7a049 0338-0355 HUMAN PRESCRIPTION DRUG Osmitrol Mannitol INJECTION, SOLUTION INTRAVENOUS 19640608 NDA NDA013684 Baxter Healthcare Corporation MANNITOL 15 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] N 20181231 0338-0357_57c99c24-bbd8-4b9d-b29c-67e2c2d7a049 0338-0357 HUMAN PRESCRIPTION DRUG Osmitrol Mannitol INJECTION, SOLUTION INTRAVENOUS 19640608 NDA NDA013684 Baxter Healthcare Corporation MANNITOL 20 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] N 20181231 0338-0409_8e0709ad-9a47-4656-8049-8e63f96258bd 0338-0409 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose Lidocaine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19810422 NDA NDA018461 Baxter Healthcare Corporation LIDOCAINE HYDROCHLORIDE 4 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0338-0411_8e0709ad-9a47-4656-8049-8e63f96258bd 0338-0411 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose Lidocaine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19810422 NDA NDA018461 Baxter Healthcare Corporation LIDOCAINE HYDROCHLORIDE 8 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0338-0431_9930df8e-e1d7-495f-8f68-9a96604164f5 0338-0431 HUMAN PRESCRIPTION DRUG Heparin Sodium and Sodium Chloride HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19820428 NDA NDA018609 Baxter Healthcare Corporation HEPARIN SODIUM 200 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0338-0433_9930df8e-e1d7-495f-8f68-9a96604164f5 0338-0433 HUMAN PRESCRIPTION DRUG Heparin Sodium and Sodium Chloride HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 19820428 NDA NDA018609 Baxter Healthcare Corporation HEPARIN SODIUM 200 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0338-0499_d3b0b859-bc5a-4e88-8fe9-eb2abcde6b13 0338-0499 HUMAN PRESCRIPTION DRUG ProSol Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid and Tyrosine INJECTION, SOLUTION INTRAVENOUS 19980826 NDA NDA020849 Baxter Healthcare Corporation VALINE; LYSINE ACETATE; HISTIDINE; ISOLEUCINE; LEUCINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE 1.44; 1.35; 1.18; 1.08; 1.08; 1; 980; 760; 320; 2.76; 2.06; 1.96; 1.34; 1.02; 1.02; 600; 50 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-0502_4f347cf2-cf17-437e-b2eb-40d12c867aa3 0338-0502 HUMAN PRESCRIPTION DRUG Clinisol Lysine, Leucine, Phenylalanine, Valine, Histidine, Isoleucine, Methionine, Threonine, Tryptophan, Alanine, Arginine, Glycine, Proline, Glutamic Acid, Serine, Aspartic Acid, Tyrosine INJECTION, SOLUTION INTRAVENOUS 19960830 ANDA ANDA020512 Baxter Healthcare Corporation LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; HISTIDINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE 1.18; 1.04; 1.04; 960; 894; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 749; 592; 434; 39 g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-0503_e5f69d6f-5a8d-434f-8a93-27ad07f771af 0338-0503 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride Gentamicin Sulfate INJECTION, SOLUTION INTRAVENOUS 19820907 ANDA ANDA062373 Baxter Healthcare Corporation GENTAMICIN SULFATE 80 mg/100mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0338-0505_e5f69d6f-5a8d-434f-8a93-27ad07f771af 0338-0505 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride Gentamicin Sulfate INJECTION, SOLUTION INTRAVENOUS 19820907 ANDA ANDA062373 Baxter Healthcare Corporation GENTAMICIN SULFATE 100 mg/100mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0338-0507_e5f69d6f-5a8d-434f-8a93-27ad07f771af 0338-0507 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride Gentamicin Sulfate INJECTION, SOLUTION INTRAVENOUS 19820907 ANDA ANDA062373 Baxter Healthcare Corporation GENTAMICIN SULFATE 60 mg/50mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0338-0509_e5f69d6f-5a8d-434f-8a93-27ad07f771af 0338-0509 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride Gentamicin Sulfate INJECTION, SOLUTION INTRAVENOUS 19820907 ANDA ANDA062373 Baxter Healthcare Corporation GENTAMICIN SULFATE 80 mg/50mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0338-0511_e5f69d6f-5a8d-434f-8a93-27ad07f771af 0338-0511 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate in Sodium Chloride Gentamicin Sulfate INJECTION, SOLUTION INTRAVENOUS 19820907 ANDA ANDA062373 Baxter Healthcare Corporation GENTAMICIN SULFATE 100 mg/50mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0338-0518_ff58d256-c2af-459a-93cd-f8e88e935653 0338-0518 HUMAN PRESCRIPTION DRUG Intralipid SOYBEAN OIL EMULSION INTRAVENOUS 20141212 NDA NDA017643 Baxter Healthcare CORP SOYBEAN OIL 10 g/100mL Lipid Emulsion [EPC],Lipids [Chemical/Ingredient] N 20181231 0338-0519_22e62204-57e1-40a1-a23a-89aa0809f9e8 0338-0519 HUMAN PRESCRIPTION DRUG Intralipid SOYBEAN OIL EMULSION INTRAVENOUS 20040401 NDA NDA020248 Baxter Healthcare CORP SOYBEAN OIL 20 g/100mL Lipid Emulsion [EPC],Lipids [Chemical/Ingredient] N 20181231 0338-0519_a32b806c-59e2-4c5a-bd65-305edc8ec7d0 0338-0519 HUMAN PRESCRIPTION DRUG Intralipid SOYBEAN OIL EMULSION INTRAVENOUS 20040401 NDA NDA020248 Baxter Healthcare Corporation SOYBEAN OIL 20 g/100mL Lipid Emulsion [EPC],Lipids [Chemical/Ingredient] N 20181231 0338-0519_a8e8188b-b08b-4d98-9df8-fdd5b958ca91 0338-0519 HUMAN PRESCRIPTION DRUG Intralipid SOYBEAN OIL EMULSION INTRAVENOUS 20040401 NDA NDA018449 Baxter Healthcare CORP SOYBEAN OIL 20 g/100mL Lipid Emulsion [EPC],Lipids [Chemical/Ingredient] N 20181231 0338-0519_c6b7af5f-0d61-4933-bf9b-4d299c2b71c1 0338-0519 HUMAN PRESCRIPTION DRUG Intralipid SOYBEAN OIL EMULSION INTRAVENOUS 20040401 NDA NDA018449 Baxter Healthcare CORP SOYBEAN OIL 20 g/100mL Lipid Emulsion [EPC],Lipids [Chemical/Ingredient] N 20181231 0338-0520_533873b0-2594-4a42-bfa5-0da0fdc730c9 0338-0520 HUMAN PRESCRIPTION DRUG Intralipid SOYBEAN OIL EMULSION INTRAVENOUS 20040401 NDA NDA019942 Baxter Healthcare Corporation SOYBEAN OIL 30 g/100mL Lipid Emulsion [EPC],Lipids [Chemical/Ingredient] N 20181231 0338-0520_f47da9dc-67d6-40b0-86f4-91d36a17c40e 0338-0520 HUMAN PRESCRIPTION DRUG Intralipid SOYBEAN OIL EMULSION INTRAVENOUS 20040401 NDA NDA019942 Baxter Healthcare CORP SOYBEAN OIL 30 g/100mL Lipid Emulsion [EPC],Lipids [Chemical/Ingredient] N 20181231 0338-0549_24b42d47-26ae-473f-b648-a4e65004f51e 0338-0549 HUMAN PRESCRIPTION DRUG Heparin Sodium in Dextrose HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20101231 NDA NDA018814 Baxter Healthcare Corporation HEPARIN SODIUM 4000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 0338-0550_24b42d47-26ae-473f-b648-a4e65004f51e 0338-0550 HUMAN PRESCRIPTION DRUG Heparin Sodium in Dextrose HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20101231 NDA NDA018814 Baxter Healthcare Corporation HEPARIN SODIUM 5000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 0338-0551_9a82fe97-2aca-4791-9adb-0c2f2215d6fd 0338-0551 HUMAN PRESCRIPTION DRUG Dextrose Dextrose Monohydrate INJECTION INTRAVENOUS 19921207 NDA NDA020179 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 5 g/100mL N 20181231 0338-0552_24b42d47-26ae-473f-b648-a4e65004f51e 0338-0552 HUMAN PRESCRIPTION DRUG Heparin Sodium in Dextrose HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20101231 NDA NDA018814 Baxter Healthcare Corporation HEPARIN SODIUM 10000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 0338-0553_08c72039-c2a9-4a97-a3c8-a7c74980f2cc 0338-0553 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 19921207 NDA NDA020178 Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0603_bfb92854-c00e-454f-b11f-7b506df4f9c4 0338-0603 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19820323 NDA NDA018629 Baxter Healthcare Corporation POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 150; 5; 330 mg/100mL; g/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0644_fdaafec1-a6f8-4aac-bbcb-ad623ef0703e 0338-0644 HUMAN PRESCRIPTION DRUG Travasol Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine INJECTION INTRAVENOUS 19840823 NDA NDA018931 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE 730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-0656_9f00c194-4f98-499e-b58f-c83cd8b6962d 0338-0656 HUMAN PRESCRIPTION DRUG Acetic Acid Acetic Acid IRRIGANT IRRIGATION 19820219 NDA NDA018523 Baxter Healthcare Corporation ACETIC ACID 250 mg/100mL N 20191231 0338-0663_bfb92854-c00e-454f-b11f-7b506df4f9c4 0338-0663 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018037 Baxter Healthcare Corporation POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 150; 5; 200 mg/100mL; g/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0669_bfb92854-c00e-454f-b11f-7b506df4f9c4 0338-0669 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018008 Baxter Healthcare Corporation POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 75; 5; 450 mg/100mL; g/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0671_bfb92854-c00e-454f-b11f-7b506df4f9c4 0338-0671 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018008 Baxter Healthcare Corporation POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 150; 5; 450 mg/100mL; g/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0673_bfb92854-c00e-454f-b11f-7b506df4f9c4 0338-0673 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018008 Baxter Healthcare Corporation POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 224; 5; 450 mg/100mL; g/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0675_bfb92854-c00e-454f-b11f-7b506df4f9c4 0338-0675 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018008 Baxter Healthcare Corporation POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 300; 5; 450 mg/100mL; g/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0683_d791b999-884f-4404-b5a7-6a1fa5846aef 0338-0683 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose Potassium Chloride and Dextrose Monohydrate INJECTION, SOLUTION INTRAVENOUS 19790201 NDA NDA017634 Baxter Healthcare Corporation POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE 150; 5 mg/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0691_5ab0219a-78af-4911-a982-1bafc97db420 0338-0691 HUMAN PRESCRIPTION DRUG Potassium Chloride in Sodium Chloride Potassium Chloride and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA017648 Baxter Healthcare Corporation SODIUM CHLORIDE; POTASSIUM CHLORIDE 900; 150 mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0695_5ab0219a-78af-4911-a982-1bafc97db420 0338-0695 HUMAN PRESCRIPTION DRUG Potassium Chloride in Sodium Chloride Potassium Chloride and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA017648 Baxter Healthcare Corporation SODIUM CHLORIDE; POTASSIUM CHLORIDE 900; 300 mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0703_f9952bbd-8532-4ded-a3a4-08f1f50400b0 0338-0703 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19891226 NDA NDA019904 Baxter Healthcare Corporation POTASSIUM CHLORIDE 29.8 g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0704_5ab0219a-78af-4911-a982-1bafc97db420 0338-0704 HUMAN PRESCRIPTION DRUG Potassium Chloride in Sodium Chloride Potassium Chloride and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA017648 Baxter Healthcare Corporation SODIUM CHLORIDE; POTASSIUM CHLORIDE 450; 150 mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0705_f9952bbd-8532-4ded-a3a4-08f1f50400b0 0338-0705 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19891226 NDA NDA019904 Baxter Healthcare Corporation POTASSIUM CHLORIDE 14.9 g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0707_f9952bbd-8532-4ded-a3a4-08f1f50400b0 0338-0707 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19891226 NDA NDA019904 Baxter Healthcare Corporation POTASSIUM CHLORIDE 22.4 g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0709_f9952bbd-8532-4ded-a3a4-08f1f50400b0 0338-0709 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19891226 NDA NDA019904 Baxter Healthcare Corporation POTASSIUM CHLORIDE 7.46 g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0719_4f55c234-b810-44d3-babf-88fedb785aa7 0338-0719 HUMAN PRESCRIPTION DRUG Dextrose Dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 19790828 NDA NDA017521 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 70 g/100mL N 20181231 0338-0719_e9dab1ed-fa03-4e85-825a-8a1caf67d0d8 0338-0719 HUMAN PRESCRIPTION DRUG DEXTROSE Dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 19910702 NDA NDA020047 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 70 g/100mL N 20181231 0338-0803_bfb92854-c00e-454f-b11f-7b506df4f9c4 0338-0803 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19850405 NDA NDA019308 Baxter Healthcare Corporation POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 150; 5; 900 mg/100mL; g/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0807_bfb92854-c00e-454f-b11f-7b506df4f9c4 0338-0807 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Potassium Chloride, Dextrose Monohydrate and Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19850405 NDA NDA019308 Baxter Healthcare Corporation POTASSIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 300; 5; 900 mg/100mL; g/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-0811_b2445ec0-3901-45db-9ac4-f91e2970595c 0338-0811 HUMAN PRESCRIPTION DRUG Potassium Chloride in Lactated Ringers and Dextrose DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19850405 NDA NDA019367 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE 5; 600; 310; 179; 20 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20191231 0338-1005_4fbef11e-39d8-45c9-9644-a0c6a19f5149 0338-1005 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride and Dextrose Dopamine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19870327 NDA NDA019615 Baxter Healthcare Corporation DOPAMINE HYDROCHLORIDE 80 mg/100mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0338-1007_4fbef11e-39d8-45c9-9644-a0c6a19f5149 0338-1007 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride and Dextrose Dopamine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19870327 NDA NDA019615 Baxter Healthcare Corporation DOPAMINE HYDROCHLORIDE 160 mg/100mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0338-1009_4fbef11e-39d8-45c9-9644-a0c6a19f5149 0338-1009 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride and Dextrose Dopamine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19870327 NDA NDA019615 Baxter Healthcare Corporation DOPAMINE HYDROCHLORIDE 320 mg/100mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0338-1013_4988ccda-d980-425e-8277-daec2ccbf03b 0338-1013 HUMAN PRESCRIPTION DRUG OXACILLIN OXACILLIN INJECTION, SOLUTION INTRAVENOUS 19891026 NDA NDA050640 Baxter Healthcare Corporation OXACILLIN SODIUM 1 g/50mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0338-1015_4988ccda-d980-425e-8277-daec2ccbf03b 0338-1015 HUMAN PRESCRIPTION DRUG OXACILLIN OXACILLIN INJECTION, SOLUTION INTRAVENOUS 19891026 NDA NDA050640 Baxter Healthcare Corporation OXACILLIN SODIUM 2 g/50mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0338-1017_e938575e-57ca-4ab0-964f-adcd05d78a33 0338-1017 HUMAN PRESCRIPTION DRUG NAFCILLIN NAFCILLIN INJECTION, SOLUTION INTRAVENOUS 19891031 NDA NDA050655 Baxter Healthcare Corporation NAFCILLIN SODIUM 1 g/50mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0338-1019_e938575e-57ca-4ab0-964f-adcd05d78a33 0338-1019 HUMAN PRESCRIPTION DRUG NAFCILLIN NAFCILLIN INJECTION, SOLUTION INTRAVENOUS 19891031 NDA NDA050655 Baxter Healthcare Corporation NAFCILLIN SODIUM 2 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0338-1021_f5cff3fe-7d1f-466e-b6c4-e1097d2bffd0 0338-1021 HUMAN PRESCRIPTION DRUG PENICILLIN G POTASSIUM PENICILLIN G INJECTION, SOLUTION INTRAVENOUS 19900625 NDA NDA050638 Baxter Healthcare Corporation PENICILLIN G POTASSIUM 1000000 [iU]/50mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0338-1023_f5cff3fe-7d1f-466e-b6c4-e1097d2bffd0 0338-1023 HUMAN PRESCRIPTION DRUG PENICILLIN G POTASSIUM PENICILLIN G INJECTION, SOLUTION INTRAVENOUS 19900625 NDA NDA050638 Baxter Healthcare Corporation PENICILLIN G POTASSIUM 2000000 [iU]/50mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0338-1025_f5cff3fe-7d1f-466e-b6c4-e1097d2bffd0 0338-1025 HUMAN PRESCRIPTION DRUG PENICILLIN G POTASSIUM PENICILLIN G INJECTION, SOLUTION INTRAVENOUS 19900625 NDA NDA050638 Baxter Healthcare Corporation PENICILLIN G POTASSIUM 3000000 [iU]/50mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0338-1047_b3c01ebd-1730-4b50-ac9b-16c5dfce8c24 0338-1047 HUMAN PRESCRIPTION DRUG Nitroglycerin In Dextrose Nitroglycerin INJECTION INTRAVENOUS 19891229 NDA NDA019970 Baxter Healthcare Company NITROGLYCERIN 10 mg/100mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0338-1049_b3c01ebd-1730-4b50-ac9b-16c5dfce8c24 0338-1049 HUMAN PRESCRIPTION DRUG Nitroglycerin In Dextrose Nitroglycerin INJECTION INTRAVENOUS 19891229 NDA NDA019970 Baxter Healthcare Company NITROGLYCERIN 20 mg/100mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0338-1051_b3c01ebd-1730-4b50-ac9b-16c5dfce8c24 0338-1051 HUMAN PRESCRIPTION DRUG Nitroglycerin In Dextrose Nitroglycerin INJECTION INTRAVENOUS 19891229 NDA NDA019970 Baxter Healthcare Company NITROGLYCERIN 40 mg/100mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0338-1055_819f3ab0-8a53-4cb4-9fcf-b7d837f0ac81 0338-1055 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole INJECTION, SOLUTION INTRAVENOUS 19811224 NDA NDA018657 Baxter Healthcare Corporation METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0338-1073_9b33db96-6e6e-4e15-9217-337c1202a885 0338-1073 HUMAN PRESCRIPTION DRUG Dobutamine Hydrochloride in Dextrose Dobutamine Hydrochloride INJECTION INTRAVENOUS 19930927 NDA NDA020255 Baxter Healthcare Corporation DOBUTAMINE HYDROCHLORIDE 100 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20181231 0338-1075_9b33db96-6e6e-4e15-9217-337c1202a885 0338-1075 HUMAN PRESCRIPTION DRUG Dobutamine Hydrochloride in Dextrose Dobutamine Hydrochloride INJECTION INTRAVENOUS 19930927 NDA NDA020255 Baxter Healthcare Corporation DOBUTAMINE HYDROCHLORIDE 200 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20181231 0338-1077_9b33db96-6e6e-4e15-9217-337c1202a885 0338-1077 HUMAN PRESCRIPTION DRUG Dobutamine Hydrochloride in Dextrose Dobutamine Hydrochloride INJECTION INTRAVENOUS 19930923 NDA NDA020255 Baxter Healthcare Corporation DOBUTAMINE HYDROCHLORIDE 400 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20181231 0338-1083_66a68670-ed20-4707-ba66-14898b21fb98 0338-1083 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 5 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1089_66a68670-ed20-4707-ba66-14898b21fb98 0338-1089 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 5 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1091_66a68670-ed20-4707-ba66-14898b21fb98 0338-1091 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 10 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1093_66a68670-ed20-4707-ba66-14898b21fb98 0338-1093 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1095_66a68670-ed20-4707-ba66-14898b21fb98 0338-1095 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 25 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1099_66a68670-ed20-4707-ba66-14898b21fb98 0338-1099 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 15 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1101_66a68670-ed20-4707-ba66-14898b21fb98 0338-1101 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1103_66a68670-ed20-4707-ba66-14898b21fb98 0338-1103 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 365; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 25 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1107_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1107 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 5 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1109_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1109 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 10 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1113_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1113 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 297; 261; 51; 77; 33; 5 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1115_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1115 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 297; 261; 51; 77; 33; 10 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1119_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1119 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 297; 261; 51; 77; 33; 25 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1123_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1123 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 340; 261; 51; 59; 33; 15 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1125_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1125 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 340; 261; 51; 59; 33; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1127_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1127 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 340; 261; 51; 59; 33; 25 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1130_d70e8b14-bb74-43ce-9690-7ed9835b318b 0338-1130 HUMAN PRESCRIPTION DRUG Premasol - sulfite-free (Amino Acid) LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20030619 ANDA ANDA075880 Baxter Healthcare Corporation LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE 1.4; .82; .82; .78; .48; .48; .42; .34; .2; .24; 1.2; .68; .54; .5; .38; .36; .32; 25; .016 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1131_d70e8b14-bb74-43ce-9690-7ed9835b318b 0338-1131 HUMAN PRESCRIPTION DRUG Premasol - sulfite-free (Amino Acid) LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20030619 ANDA ANDA075880 Baxter Healthcare Corporation LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE .84; .49; .49; .47; .29; .29; .25; .2; .12; .14; .73; .41; .32; .3; .23; .22; .19; 15; .014 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1132_66a68670-ed20-4707-ba66-14898b21fb98 0338-1132 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 5 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1133_66a68670-ed20-4707-ba66-14898b21fb98 0338-1133 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 5 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1134_66a68670-ed20-4707-ba66-14898b21fb98 0338-1134 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 20120320 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 10 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1135_66a68670-ed20-4707-ba66-14898b21fb98 0338-1135 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 438; 489; 289; 213; 17; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL N 20181231 0338-1136_66a68670-ed20-4707-ba66-14898b21fb98 0338-1136 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 25 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1137_66a68670-ed20-4707-ba66-14898b21fb98 0338-1137 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 15 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1138_66a68670-ed20-4707-ba66-14898b21fb98 0338-1138 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1139_66a68670-ed20-4707-ba66-14898b21fb98 0338-1139 HUMAN PRESCRIPTION DRUG CLINIMIX Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose INJECTION INTRAVENOUS 19970929 NDA NDA020734 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; DEXTROSE 365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 25 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-1142_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1142 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 5 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1143_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1143 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 201; 154; 159; 110; 165; 160; 132; 116; 50; 570; 283; 316; 187; 138; 11; 217; 261; 51; 112; 33; 10 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1144_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1144 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 297; 261; 51; 77; 33; 5 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1145_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1145 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 297; 261; 51; 77; 33; 10 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1146_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1146 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 311; 238; 247; 170; 255; 247; 204; 179; 77; 880; 438; 489; 289; 213; 17; 297; 261; 51; 77; 33; 25 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1147_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1147 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 340; 261; 51; 59; 33; 15 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1148_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1148 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 340; 261; 51; 59; 33; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1149_7f22911e-2782-4e88-a0b4-d66eef9d4c3d 0338-1149 HUMAN PRESCRIPTION DRUG CLINIMIX E Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose INJECTION INTRAVENOUS 19970326 NDA NDA020678 Baxter Healthcare Corporation LEUCINE; PHENYLALANINE; LYSINE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE 365; 280; 290; 200; 300; 290; 240; 210; 90; 1035; 515; 575; 340; 250; 20; 340; 261; 51; 59; 33; 25 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-1301_d0facf32-bf10-4a2c-b9ab-8e389b3de449 0338-1301 HUMAN PRESCRIPTION DRUG Cefepime cefepime INJECTION, SOLUTION INTRAVENOUS 20080805 NDA NDA050817 Baxter Healthcare Corporation CEFEPIME HYDROCHLORIDE 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0338-1305_e5b2fd74-ed20-48dd-adc8-9510f2f31746 0338-1305 HUMAN PRESCRIPTION DRUG MESNEX mesna INJECTION, SOLUTION INTRAVENOUS 19881230 NDA NDA019884 Baxter Healthcare Corporation MESNA 100 mg/mL Cytoprotective Agent [EPC] N 20181231 0338-1452_3ef18374-6365-441c-b745-5581b542191b 0338-1452 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018016 Baxter Healthcare Corporation SODIUM CHLORIDE 5 g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-3410_3c2a4bb5-46b1-465f-9f87-d02680c901da 0338-3410 HUMAN PRESCRIPTION DRUG Clindamycin phosphate Clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 20170628 ANDA ANDA208084 Baxter Healthcare Corporation CLINDAMYCIN PHOSPHATE 300 mg/50mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 0338-3503_312ee59b-8e5a-47dd-af4c-cac122e1491f 0338-3503 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin Sodium INJECTION, SOLUTION INTRAVENOUS 19910328 ANDA ANDA063002 Baxter Healthcare Corporation CEFAZOLIN SODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0338-3508_977e4907-2364-434a-8cef-281115b80a41 0338-3508 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin Sodium INJECTION, SOLUTION INTRAVENOUS 20150807 NDA NDA207131 Baxter Healthcare Corporation CEFAZOLIN SODIUM 2 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0338-3551_4f3188e9-94dd-4ec9-a690-09b85ea23b44 0338-3551 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19581114 NDA NDA050671 Baxter Healthcare Corporation VANCOMYCIN HYDROCHLORIDE 500 mg/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0338-3552_4f3188e9-94dd-4ec9-a690-09b85ea23b44 0338-3552 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19581114 NDA NDA050671 Baxter Healthcare Corporation VANCOMYCIN HYDROCHLORIDE 1 g/200mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0338-3580_4f3188e9-94dd-4ec9-a690-09b85ea23b44 0338-3580 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19581114 NDA NDA050671 Baxter Healthcare Corporation VANCOMYCIN HYDROCHLORIDE 750 mg/150mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0338-3581_4f3188e9-94dd-4ec9-a690-09b85ea23b44 0338-3581 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19581114 NDA NDA050671 Baxter Healthcare Corporation VANCOMYCIN HYDROCHLORIDE 500 mg/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0338-3582_4f3188e9-94dd-4ec9-a690-09b85ea23b44 0338-3582 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19581114 NDA NDA050671 Baxter Healthcare Corporation VANCOMYCIN HYDROCHLORIDE 750 mg/150mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0338-3583_4f3188e9-94dd-4ec9-a690-09b85ea23b44 0338-3583 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 19581114 NDA NDA050671 Baxter Healthcare Corporation VANCOMYCIN HYDROCHLORIDE 1 g/200mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0338-3612_3c2a4bb5-46b1-465f-9f87-d02680c901da 0338-3612 HUMAN PRESCRIPTION DRUG Clindamycin phosphate Clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 20170628 ANDA ANDA208084 Baxter Healthcare Corporation CLINDAMYCIN PHOSPHATE 600 mg/50mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 0338-3814_3c2a4bb5-46b1-465f-9f87-d02680c901da 0338-3814 HUMAN PRESCRIPTION DRUG Clindamycin phosphate Clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 20170628 ANDA ANDA208084 Baxter Healthcare Corporation CLINDAMYCIN PHOSPHATE 900 mg/50mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 0338-3991_f4f6608b-4038-4907-bd81-904372c38c10 0338-3991 HUMAN PRESCRIPTION DRUG IFEX ifosfamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19881230 NDA NDA019763 Baxter Healthcare Corporation IFOSFAMIDE 1 g/20mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0338-3993_f4f6608b-4038-4907-bd81-904372c38c10 0338-3993 HUMAN PRESCRIPTION DRUG IFEX ifosfamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19881230 NDA NDA019763 Baxter Healthcare Corporation IFOSFAMIDE 3 g/60mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0338-4210_b3f69e25-1b87-4507-81fa-582ea084673d 0338-4210 PLASMA DERIVATIVE TISSEEL Fibrin Sealant fibrinogen human, human thrombin KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0338-4211_b3f69e25-1b87-4507-81fa-582ea084673d 0338-4211 PLASMA DERIVATIVE TISSEEL Fibrin Sealant fibrinogen human, human thrombin KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0338-4212_b3f69e25-1b87-4507-81fa-582ea084673d 0338-4212 PLASMA DERIVATIVE TISSEEL Fibrin Sealant fibrinogen human, human thrombin KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0338-4301_b3f69e25-1b87-4507-81fa-582ea084673d 0338-4301 PLASMA DERIVATIVE TISSEEL Fibrin Sealant fibrinogen human, human thrombin KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0338-4302_b3f69e25-1b87-4507-81fa-582ea084673d 0338-4302 PLASMA DERIVATIVE TISSEEL Fibrin Sealant fibrinogen human, human thrombin KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0338-4303_b3f69e25-1b87-4507-81fa-582ea084673d 0338-4303 PLASMA DERIVATIVE TISSEEL Fibrin Sealant fibrinogen human, human thrombin KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0338-5002_26c335ab-eb61-4ed0-b5d0-80b9d3a6f550 0338-5002 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, SOLUTION INTRAVENOUS 20050823 ANDA ANDA065224 Baxter Healthcare Corporation CEFTRIAXONE SODIUM 1 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0338-5003_26c335ab-eb61-4ed0-b5d0-80b9d3a6f550 0338-5003 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, SOLUTION INTRAVENOUS 20050823 ANDA ANDA065224 Baxter Healthcare Corporation CEFTRIAXONE SODIUM 2 g/50mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0338-5197_b0c21b04-6546-4bf8-b3df-a2cd152b6b90 0338-5197 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION, SOLUTION INTRAVENOUS 20010510 ANDA ANDA075591 Baxter Healthcare Corporation FAMOTIDINE 20 mg/50mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0338-6010_9ece85fc-d06c-40fb-a521-4c2690f03b86 0338-6010 HUMAN PRESCRIPTION DRUG Milrinone Lactate in Dextrose MILRINONE LACTATE INJECTION, SOLUTION INTRAVENOUS 20020528 ANDA ANDA075834 Baxter Healthcare Corporation MILRINONE LACTATE .2 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0338-6011_9ece85fc-d06c-40fb-a521-4c2690f03b86 0338-6011 HUMAN PRESCRIPTION DRUG Milrinone Lactate in Dextrose MILRINONE LACTATE INJECTION, SOLUTION INTRAVENOUS 20020528 ANDA ANDA075834 Baxter Healthcare Corporation MILRINONE LACTATE .2 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0338-6045_3655c545-b7fb-40cd-bd74-6f1ba6b4d4a2 0338-6045 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION, SOLUTION INTRAVENOUS 20040729 ANDA ANDA076766 Baxter Healthcare Corporation FLUCONAZOLE 400 mg/200mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0338-6046_3655c545-b7fb-40cd-bd74-6f1ba6b4d4a2 0338-6046 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION, SOLUTION INTRAVENOUS 20040729 ANDA ANDA076766 Baxter Healthcare Corporation FLUCONAZOLE 200 mg/100mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0338-6304_00fcfb0d-6f11-48c9-9bee-2660b1893334 0338-6304 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19701209 NDA NDA016677 Baxter Healthcare Corporation SODIUM CHLORIDE 9 g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6307_77767f95-e9fe-4b49-b49d-265e7cded459 0338-6307 HUMAN PRESCRIPTION DRUG Lactated Ringers Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016682 Baxter Healthcare Corporation SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE 600; 310; 30; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-6308_ce789852-ac86-41f5-86ee-65055754ed92 0338-6308 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride dextrose and sodium chloride INJECTION, SOLUTION INTRAVENOUS 19710322 NDA NDA016683 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; 450 g/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6329_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6329 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018008 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 450; 75 g/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6330_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6330 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018008 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 450; 150 g/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6331_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6331 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018008 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 450; 224 g/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6332_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6332 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018008 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 450; 300 g/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6333_00fcfb0d-6f11-48c9-9bee-2660b1893334 0338-6333 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018016 Baxter Healthcare Corporation SODIUM CHLORIDE 4.5 g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6334_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6334 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018037 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 200; 75 g/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6335_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6335 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018037 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 200; 150 g/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6336_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6336 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018037 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 200; 224 g/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6337_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6337 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19790202 NDA NDA018037 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 200; 300 g/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6342_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6342 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19850405 NDA NDA019308 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 900; 150 g/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6343_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6343 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19850405 NDA NDA019308 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 900; 300 g/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6346_0fd25970-d54c-43d3-8f39-533ce9d1bcb7 0338-6346 HUMAN PRESCRIPTION DRUG Dextrose Dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 19710304 NDA NDA016673 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 50 g/1000mL N 20181231 0338-6347_0fd25970-d54c-43d3-8f39-533ce9d1bcb7 0338-6347 HUMAN PRESCRIPTION DRUG Dextrose Dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 19710125 NDA NDA016694 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 100 g/1000mL N 20181231 0338-6348_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6348 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19820323 NDA NDA018629 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 330; 150 g/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6349_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6349 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19820323 NDA NDA018629 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 330; 224 g/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-6350_a5043890-7a8f-4718-bfc3-d20792d4bd61 0338-6350 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride Dextrose monohydrate, Sodium Chloride and Potassium Chloride INJECTION, SOLUTION INTRAVENOUS 19820323 NDA NDA018629 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 5; 330; 300 g/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-8402_b3f69e25-1b87-4507-81fa-582ea084673d 0338-8402 PLASMA DERIVATIVE TISSEEL Fibrin Sealant fibrinogen human, human thrombin SOLUTION TOPICAL 19980501 BLA BLA103980 Baxter Healthcare Corporation FIBRINOGEN HUMAN; HUMAN THROMBIN 90; 500 [iU]/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 0338-8503_92fc93e1-9695-4705-90c5-4452a80bb074 0338-8503 PLASMA DERIVATIVE ARTISS Fibrin Sealant Fibrinogen Human, Human Thrombin SOLUTION TOPICAL 20080319 BLA BLA125266 Baxter Healthcare Corporation FIBRINOGEN HUMAN; HUMAN THROMBIN 90; 4 mg/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 0338-8701_0c67aa31-d002-43d2-bc87-c8c1c434abe2 0338-8701 HUMAN PRESCRIPTION DRUG TachoSil THROMBIN HUMAN and FIBRINOGEN PATCH TOPICAL 20100405 BLA BLA125351 Baxter Healthcare Corporation HUMAN THROMBIN; FIBRINOGEN HUMAN 2; 5.5 [USP'U]/1; mg/1 Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 0338-8702_0c67aa31-d002-43d2-bc87-c8c1c434abe2 0338-8702 HUMAN PRESCRIPTION DRUG TachoSil THROMBIN HUMAN and FIBRINOGEN PATCH TOPICAL 20100405 BLA BLA125351 Baxter Healthcare Corporation HUMAN THROMBIN; FIBRINOGEN HUMAN 2; 5.5 [USP'U]/1; mg/1 Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 0338-8703_0c67aa31-d002-43d2-bc87-c8c1c434abe2 0338-8703 HUMAN PRESCRIPTION DRUG TachoSil THROMBIN HUMAN and FIBRINOGEN PATCH TOPICAL 20100405 BLA BLA125351 Baxter Healthcare Corporation HUMAN THROMBIN; FIBRINOGEN HUMAN 2; 5.5 [USP'U]/1; mg/1 Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 0338-9517_7d63413c-2659-4be8-9926-a0d2ac9c0fe1 0338-9517 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20180115 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0338-9517_8a91c5f5-c52c-4750-82b5-6bd716485a54 0338-9517 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20180131 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0338-9520_08ac2020-d7a8-4f33-8483-8c528d47542a 0338-9520 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171019 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE .9 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9521_940b1b3e-8c77-470a-9169-208a114387a7 0338-9521 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION INTRAVENOUS 20171019 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 2.5 g/50mL N 20181231 0338-9523_54869f91-4d0e-4b2c-a818-ab899a252934 0338-9523 HUMAN PRESCRIPTION DRUG DEXTROSE dextrose monohydrate INJECTION INTRAVENOUS 20180115 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 5 g/100mL N 20191231 0338-9525_08ac2020-d7a8-4f33-8483-8c528d47542a 0338-9525 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171019 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE .9 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9527_940b1b3e-8c77-470a-9169-208a114387a7 0338-9527 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION INTRAVENOUS 20171019 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 2.5 g/50mL N 20181231 0338-9530_fc8844f4-e532-46b7-baee-b4b156f1add9 0338-9530 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 50 mg/100mL N 20181231 0338-9531_f66c5fbd-dc71-4353-9240-f0e53ebb57aa 0338-9531 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9533_fc8844f4-e532-46b7-baee-b4b156f1add9 0338-9533 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 50 mg/50mL N 20181231 0338-9535_f66c5fbd-dc71-4353-9240-f0e53ebb57aa 0338-9535 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9536_9904f73f-525a-42ac-86ff-8ad2d4fd3a1f 0338-9536 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 2.5 g/50mL N 20181231 0338-9539_9904f73f-525a-42ac-86ff-8ad2d4fd3a1f 0338-9539 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 5 g/100mL N 20181231 0338-9540_0e80cf66-7b95-4535-bb8e-8a79b90b705c 0338-9540 HUMAN PRESCRIPTION DRUG Clinolipid Olive Oil and Soybean Oil INJECTION, EMULSION INTRAVENOUS 20160101 NDA NDA204508 Baxter Healthcare Corporation OLIVE OIL; SOYBEAN OIL 16; 4 g/100mL; g/100mL Lipid Emulsion [EPC],Lipids [Chemical/Ingredient],Lipid Emulsion [EPC],Lipids [Chemical/Ingredient] N 20181231 0338-9541_5a7cb4bd-343c-4386-bc77-47c66dc5d72d 0338-9541 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole INJECTION, SOLUTION INTRAVENOUS 19811224 NDA NDA018657 Baxter Healthcare Corporation METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0338-9542_ee010eb9-77dd-40cb-b456-062a4c4235eb 0338-9542 HUMAN PRESCRIPTION DRUG Sodium Chloride sodium chloride INJECTION, SOLUTION INTRAVENOUS 20140421 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 9 g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9543_43f694a9-9ac0-4b4f-961c-8c686d8e8e57 0338-9543 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION, SOLUTION INTRAVENOUS 19701209 NDA NDA016677 Baxter Healthcare Corporation SODIUM CHLORIDE 9 g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9545_7c9afaf9-76fd-4f0f-9676-ee6a2aebab84 0338-9545 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 20170420 NDA NDA208083 Baxter Healthcare Corporation CLINDAMYCIN PHOSPHATE 300 mg/50mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 0338-9546_b872a1bd-a204-448b-8702-a51aa1b2a970 0338-9546 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171005 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE .45 g/50mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9547_59d635c6-e46a-4f88-b7e9-e197e6790a87 0338-9547 HUMAN PRESCRIPTION DRUG Glucose Dextrose Monohydrate INJECTION INTRAVENOUS 20171005 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 2.5 g/50mL N 20181231 0338-9549_7c9afaf9-76fd-4f0f-9676-ee6a2aebab84 0338-9549 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 20170420 NDA NDA208083 Baxter Healthcare Corporation CLINDAMYCIN PHOSPHATE 600 mg/50mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 0338-9550_b872a1bd-a204-448b-8702-a51aa1b2a970 0338-9550 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171005 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE .9 g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9551_59d635c6-e46a-4f88-b7e9-e197e6790a87 0338-9551 HUMAN PRESCRIPTION DRUG Glucose Dextrose Monohydrate INJECTION INTRAVENOUS 20171005 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 5 g/100mL N 20181231 0338-9552_cf6ce51b-dc0c-424e-9fac-e4713bd095ed 0338-9552 HUMAN PRESCRIPTION DRUG Heparin Sodium and Sodium Chloride heparin sodium INJECTION, SOLUTION INTRAVENOUS 20171025 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation HEPARIN SODIUM 2000 [iU]/1000mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0338-9553_7c9afaf9-76fd-4f0f-9676-ee6a2aebab84 0338-9553 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 20170420 NDA NDA208083 Baxter Healthcare Corporation CLINDAMYCIN PHOSPHATE 900 mg/50mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 0338-9554_49cf6773-965a-440a-b5bb-6ac015dffd08 0338-9554 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole INJECTION, SOLUTION INTRAVENOUS 20171005 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0338-9556_cf6ce51b-dc0c-424e-9fac-e4713bd095ed 0338-9556 HUMAN PRESCRIPTION DRUG Heparin Sodium and Sodium Chloride heparin sodium INJECTION, SOLUTION INTRAVENOUS 20171025 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation HEPARIN SODIUM 1000 [iU]/500mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0338-9563_e4bbdba2-7ae3-48ed-8977-a88c149f832c 0338-9563 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171005 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9566_ae826725-59da-491a-9955-319cd0dae116 0338-9566 HUMAN PRESCRIPTION DRUG Clinimix Isoleucine, Leucine, Valine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Arginine, Histidine, Alanine, Glycine, Proline, Serine, Tyrosine, Sodium acetate, Dibasic potassium phosphate, Sodium chloride, Magnesium Chloride, Dextrose Monohydrate, Calcium chloride SOLUTION INTRAVENOUS 20171025 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation ISOLEUCINE; LEUCINE; VALINE; LYSINE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; ARGININE; HISTIDINE; ALANINE; GLYCINE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; CALCIUM CHLORIDE 1.65; 2.01; 1.6; 2; 1.1; 1.54; 1.16; .5; 3.17; 1.32; 5.7; 2.84; 1.87; 1.38; .11; 2.16; 2.61; 1.12; .51; 100; .33 g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-9567_e4bbdba2-7ae3-48ed-8977-a88c149f832c 0338-9567 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171005 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 450 mg/50mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9569_ebc4ef22-524f-4fbd-a537-1e26c7c697f7 0338-9569 HUMAN PRESCRIPTION DRUG Glucose dextrose monohydrate INJECTION INTRAVENOUS 20171005 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 5 g/100mL N 20181231 0338-9570_ae826725-59da-491a-9955-319cd0dae116 0338-9570 HUMAN PRESCRIPTION DRUG Clinimix Isoleucine, Leucine, Valine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Arginine, Histidine, Alanine, Glycine, Proline, Serine, Tyrosine, Sodium acetate, Dibasic potassium phosphate, Sodium chloride, Magnesium chloride, Dextrose Monohydrate, Calcium chloride SOLUTION INTRAVENOUS 20171025 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation ISOLEUCINE; LEUCINE; VALINE; LYSINE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; ARGININE; HISTIDINE; ALANINE; GLYCINE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; CALCIUM CHLORIDE 1.65; 2.01; 1.6; 2; 1.1; 1.54; 1.16; .5; 3.17; 1.32; 5.7; 2.84; 1.87; 1.38; .11; 2.16; 2.61; 1.12; .51; 75; .33 g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L; g/L Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-9572_e082d38c-3efa-4a63-8b22-20d389e78ca3 0338-9572 HUMAN PRESCRIPTION DRUG Bivalirudin in 0.9% Sodium Chloride Bivalirudin in 0.9% Sodium Chloride Injection INJECTION INTRAVENOUS 20171221 NDA NDA208374 Baxter Healthcare Corporation BIVALIRUDIN 250 mg/50mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20191231 0338-9573_ebc4ef22-524f-4fbd-a537-1e26c7c697f7 0338-9573 HUMAN PRESCRIPTION DRUG Glucose dextrose monohydrate INJECTION INTRAVENOUS 20171005 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation DEXTROSE MONOHYDRATE 2.5 g/50mL N 20181231 0338-9575_3d0063d8-d404-4d4a-abff-8b1adf510042 0338-9575 HUMAN PRESCRIPTION DRUG Synthamin leucine, isoleucine, lysine, valine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, arginine, glycine, proline, serine, tyrosine INJECTION, SOLUTION INTRAVENOUS 20171103 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation LEUCINE; ISOLEUCINE; LYSINE; VALINE; PHENYLALANINE; HISTIDINE; THREONINE; METHIONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; SERINE; TYROSINE 7.3; 6; 5.8; 5.8; 5.6; 4.8; 4.2; 4; 1.8; 20.7; 11.5; 10.3; 6.8; 5; 400 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL; mg/1000mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-9576_e082d38c-3efa-4a63-8b22-20d389e78ca3 0338-9576 HUMAN PRESCRIPTION DRUG Bivalirudin in 0.9% Sodium Chloride Bivalirudin in 0.9% Sodium Chloride Injection INJECTION INTRAVENOUS 20171221 NDA NDA208374 Baxter Healthcare Corporation BIVALIRUDIN 500 mg/100mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20191231 0338-9577_5cf42d1d-a199-4d47-81a4-608e39fcd080 0338-9577 HUMAN PRESCRIPTION DRUG PRIMENE Isoleucine, leucine, valine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, histidine, alanine, aspartic acid, cysteine, glutamic acid, glycine, proline, serine, tyrosine, ornitine hydrchloride, taurine INJECTION, SOLUTION INTRAVENOUS 20171122 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation ISOLEUCINE; LEUCINE; VALINE; LYSINE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; ARGININE; HISTIDINE; ALANINE; ASPARTIC ACID; CYSTEINE; GLUTAMIC ACID; GLYCINE; PROLINE; SERINE; TYROSINE; ORNITHINE HYDROCHLORIDE; TAURINE 1.675; 2.5; 1.9; 2.75; .6; 1.05; .9; .5; 2.1; .95; 2; 1.5; .47; 2.5; 1; .75; 1; .11; .8; .15 g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0338-9579_6d94bf83-b952-4553-a351-f5c23cd647e5 0338-9579 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9583_6d94bf83-b952-4553-a351-f5c23cd647e5 0338-9583 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9586_71a9fbaf-cada-4098-af30-81a6c284f54c 0338-9586 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose Lidocaine Hydrochloride INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation LIDOCAINE HYDROCHLORIDE 4 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0338-9587_ae826725-59da-491a-9955-319cd0dae116 0338-9587 HUMAN PRESCRIPTION DRUG Clinimix Isoleucine, Leucine, Valine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Arginine, Histidine, Alanine, Glycine, Proline, Serine, Tyrosine, Sodium acetate, Dibasic potassium phosphate, Sodium chloride, Magnesium chloride, Dextrose Monohydrate, Calcium chloride SOLUTION INTRAVENOUS 20171025 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation ISOLEUCINE; LEUCINE; VALINE; LYSINE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; ARGININE; HISTIDINE; ALANINE; GLYCINE; PROLINE; SERINE; TYROSINE; SODIUM ACETATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; CALCIUM CHLORIDE 5.1; 6.2; 4.93; 4.93; 3.4; 4.76; 3.57; 1.53; 9.78; 4.08; 17.6; 8.76; 5.78; 4.25; .34; 5.94; 5.22; 1.54; 1.02; 300; .66 g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L; g/2L Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0338-9590_71a9fbaf-cada-4098-af30-81a6c284f54c 0338-9590 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose Lidocaine Hydrochloride INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation LIDOCAINE HYDROCHLORIDE 4 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0338-9604_6d94bf83-b952-4553-a351-f5c23cd647e5 0338-9604 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9608_6d94bf83-b952-4553-a351-f5c23cd647e5 0338-9608 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9612_6d94bf83-b952-4553-a351-f5c23cd647e5 0338-9612 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171013 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9613_bb20c158-87af-4d19-bc07-16dbd8e6e1f0 0338-9613 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171005 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 450 mg/50mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0338-9616_bb20c158-87af-4d19-bc07-16dbd8e6e1f0 0338-9616 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE sodium chloride INJECTION INTRAVENOUS 20171005 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0360-0004_2e460cbe-17fa-4adf-e054-00144ff88e88 0360-0004 HUMAN OTC DRUG ACONITE ACONITE NAPELLUS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ACONITUM NAPELLUS 30 [hp_X]/g N 20181231 0360-0005_4a165fa1-4220-5437-e054-00144ff8d46c 0360-0005 HUMAN OTC DRUG ACONITUM ACONITUM NAPELLUS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ACONITUM NAPELLUS 6 [hp_X]/g N 20181231 0360-0010_231cf490-29ea-6ae6-e054-00144ff88e88 0360-0010 HUMAN OTC DRUG ARGENTUM NITRICUM ARGENTUM NITRICUM TABLET, ORALLY DISINTEGRATING ORAL 19550101 UNAPPROVED HOMEOPATHIC Standard Homeopathic Company SILVER NITRATE 30 [hp_X]/1 N 20181231 0360-0011_4a2880ab-d7cf-08f7-e054-00144ff8d46c 0360-0011 HUMAN OTC DRUG ARGENTUM ARGENTUM NIT. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SILVER NITRATE 6 [hp_X]/g N 20181231 0360-0014_4ab60ce2-f0c7-7405-e054-00144ff88e88 0360-0014 HUMAN OTC DRUG ALLIUM ALLIUM CEPA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ALLIUM CEPA WHOLE 30 [hp_X]/g N 20181231 0360-0015_49db3bce-00c0-32a0-e054-00144ff8d46c 0360-0015 HUMAN OTC DRUG ALLIUM ALLIUM CEPA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ALLIUM CEPA WHOLE 6 [hp_X]/g N 20181231 0360-0017_4a2c3c98-4e39-1c9b-e054-00144ff88e88 0360-0017 HUMAN OTC DRUG ALUMINA ALUMINA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ALUMINUM OXIDE 30 [hp_X]/g N 20181231 0360-0018_4a1712df-f701-03cd-e054-00144ff8d46c 0360-0018 HUMAN OTC DRUG ALUMINA ALUMINA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ALUMINUM OXIDE 6 [hp_X]/g N 20181231 0360-0023_4a52465f-dec8-11f6-e054-00144ff8d46c 0360-0023 HUMAN OTC DRUG ANTIMONIUM ANTIMONIUM CRUD. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ANTIMONY TRISULFIDE 30 [hp_X]/g N 20181231 0360-0024_4ab6d6ad-07d0-607b-e054-00144ff8d46c 0360-0024 HUMAN OTC DRUG ANTIMONIUM ANTIMONIUM CRUD. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ANTIMONY TRISULFIDE 6 [hp_X]/g N 20181231 0360-0027_49dc2d0c-e3be-232b-e054-00144ff88e88 0360-0027 HUMAN OTC DRUG ANTIMONIUM ANTIMONIUM TART. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ANTIMONY POTASSIUM TARTRATE 6 [hp_X]/g N 20181231 0360-0028_4a1802b9-3e6e-33f0-e054-00144ff8d46c 0360-0028 HUMAN OTC DRUG ANTIMONIUM ANTIMONIUM TART. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ANTIMONY POTASSIUM TARTRATE 30 [hp_X]/g N 20181231 0360-0031_4a3e2edf-4f5a-66a9-e054-00144ff8d46c 0360-0031 HUMAN OTC DRUG APIS APIS MELL. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY APIS MELLIFERA 30 [hp_X]/g N 20181231 0360-0033_4aa40d43-76e6-25db-e054-00144ff8d46c 0360-0033 HUMAN OTC DRUG APIS APIS MELL. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY APIS MELLIFERA 6 [hp_X]/g N 20181231 0360-0041_4ac89096-bc2e-0293-e054-00144ff8d46c 0360-0041 HUMAN OTC DRUG ARNICA ARNICA MONTANA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ARNICA MONTANA 30 [hp_X]/g N 20181231 0360-0043_48beed49-5c5b-0723-e054-00144ff88e88 0360-0043 HUMAN OTC DRUG Arnica Arnica Montana TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC Standard Homeopathic Company ARNICA MONTANA 6 [hp_X]/g N 20181231 0360-0048_4acb2f56-68bd-529a-e054-00144ff88e88 0360-0048 HUMAN OTC DRUG ARSENICUM ARSENICUM ALBUM TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ARSENIC TRIOXIDE 30 [hp_X]/g N 20181231 0360-0050_4acba242-18c2-693c-e054-00144ff88e88 0360-0050 HUMAN OTC DRUG ARSENICUM ARSENICUM ALBUM TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ARSENIC TRIOXIDE 6 [hp_X]/g N 20181231 0360-0053_4b448fbc-0186-3b53-e054-00144ff8d46c 0360-0053 HUMAN OTC DRUG AVENA AVENA SATIVA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY AVENA SATIVA FLOWERING TOP 30 [hp_X]/g N 20181231 0360-0056_4b565c73-a4b5-44eb-e054-00144ff8d46c 0360-0056 HUMAN OTC DRUG BARYTA BARYTA CARB. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY BARIUM CARBONATE 30 [hp_X]/g N 20181231 0360-0057_4ac8eab9-6744-1518-e054-00144ff88e88 0360-0057 HUMAN OTC DRUG BARYTA BARYTA CARB. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY BARIUM CARBONATE 6 [hp_X]/g N 20181231 0360-0061_4c84a6c3-5602-0aa7-e054-00144ff88e88 0360-0061 HUMAN OTC DRUG BELLADONNA BELLADONNA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ATROPA BELLADONNA 30 [hp_X]/g N 20181231 0360-0063_4acc60b1-7785-0b34-e054-00144ff88e88 0360-0063 HUMAN OTC DRUG BELLADONNA BELLADONNA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ATROPA BELLADONNA 6 [hp_X]/g N 20181231 0360-0067_4b44f596-cbb4-1f5f-e054-00144ff88e88 0360-0067 HUMAN OTC DRUG BERBERIS VULGARIS BERBERIS VULG. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPTHIC COMPANY BERBERIS VULGARIS ROOT BARK 30 [hp_X]/g N 20181231 0360-0068_4b57d543-23b6-2238-e054-00144ff88e88 0360-0068 HUMAN OTC DRUG BERBERIS VULGARIS BERBERIS VULG. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY BERBERIS VULGARIS ROOT BARK 6 [hp_X]/g N 20181231 0360-0070_4acc4a88-a33d-4c07-e054-00144ff8d46c 0360-0070 HUMAN OTC DRUG BORAX BORAX TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SODIUM BORATE 30 [hp_X]/g N 20181231 0360-0071_4ac9725b-ce6e-3410-e054-00144ff8d46c 0360-0071 HUMAN OTC DRUG BORAX BORAX TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SODIUM BORATE 6 [hp_X]/g N 20181231 0360-0076_4b43a6d1-165b-6cc5-e054-00144ff88e88 0360-0076 HUMAN OTC DRUG BRYONIA BRYONIA ALB. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY BRYONIA ALBA ROOT 30 [hp_X]/g N 20181231 0360-0077_4b452800-a84a-276a-e054-00144ff88e88 0360-0077 HUMAN OTC DRUG BRYONIA BRYONIA ALB. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY BRYONIA ALBA ROOT 6 [hp_X]/g N 20181231 0360-0083_4eba28a1-f0be-3669-e054-00144ff88e88 0360-0083 HUMAN OTC DRUG CALCAREA FLUORICA CALC FLUOR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CALCIUM FLUORIDE 30 [hp_X]/g N 20181231 0360-0085_4f092f87-993e-3dbc-e054-00144ff88e88 0360-0085 HUMAN OTC DRUG CALC FLOUR CALC FLOUR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CALCIUM FLUORIDE 6 [hp_X]/g N 20181231 0360-0087_4b6dc0d4-4a7b-3606-e054-00144ff8d46c 0360-0087 HUMAN OTC DRUG CALCAREA CARBONICA CALC. CARB. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_X]/g N 20181231 0360-0088_4b58eb1a-c774-4b85-e054-00144ff88e88 0360-0088 HUMAN OTC DRUG CALCAREA CARBONICA CALC. CARB. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY OYSTER SHELL CALCIUM CARBONATE, CRUDE 6 [hp_X]/g N 20181231 0360-0089_4b8186b0-ea4b-73cc-e054-00144ff8d46c 0360-0089 HUMAN OTC DRUG CALENDULA CALENDULA OFF. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CALENDULA OFFICINALIS FLOWERING TOP 30 [hp_X]/g N 20181231 0360-0090_4bbc29a8-6d8a-41a7-e054-00144ff8d46c 0360-0090 HUMAN OTC DRUG CALENDULA OFFICINALIS CALENDULA OFF. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_X]/g N 20181231 0360-0093_4be300e0-3d77-0f87-e054-00144ff8d46c 0360-0093 HUMAN OTC DRUG CANTHARIS CANTHARIS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY LYTTA VESICATORIA 30 [hp_X]/g N 20181231 0360-0094_4bd12435-7b97-10ff-e054-00144ff88e88 0360-0094 HUMAN OTC DRUG CANTHARIS CANTHARIS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY LYTTA VESICATORIA 6 [hp_X]/g N 20181231 0360-0097_4f463a8e-20c4-5674-e054-00144ff88e88 0360-0097 HUMAN OTC DRUG CALCAREA PHOSPHORICA CALC. PHOS. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY TRIBASIC CALCIUM PHOSPHATE 30 [hp_X]/g N 20181231 0360-0098_4bba6fe4-c508-01d1-e054-00144ff88e88 0360-0098 HUMAN OTC DRUG CALCAREA PHOSPHORICA CALC. PHOS. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY TRIBASIC CALCIUM PHOSPHATE 3 [hp_X]/g N 20181231 0360-0099_4f2f99bd-dd7f-6b10-e054-00144ff8d46c 0360-0099 HUMAN OTC DRUG CALC PHOS CALC. PHOS. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY TRIBASIC CALCIUM PHOSPHATE 6 [hp_X]/g N 20181231 0360-0102_4be42589-cd47-437c-e054-00144ff8d46c 0360-0102 HUMAN OTC DRUG CARBO VEG CARBO VEG. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ACTIVATED CHARCOAL 30 [hp_X]/g N 20181231 0360-0103_4bd1fba8-6aa3-2f5c-e054-00144ff88e88 0360-0103 HUMAN OTC DRUG CARBO VEG CARBO VEG. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ACTIVATED CHARCOAL 6 [hp_X]/g N 20181231 0360-0105_4f42ce01-de4b-3bed-e054-00144ff8d46c 0360-0105 HUMAN OTC DRUG CALC SULPH CALC SULPH TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CALCIUM SULFATE ANHYDROUS 30 [hp_X]/g N 20181231 0360-0107_4f32472c-d65a-2b1a-e054-00144ff88e88 0360-0107 HUMAN OTC DRUG CALC SULPH CALC SULPH TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CALCIUM SULFATE ANHYDROUS 6 [hp_X]/g N 20181231 0360-0109_4b8001ba-ad38-291d-e054-00144ff8d46c 0360-0109 HUMAN OTC DRUG CAULOPHYLLUM CAULOPHYLLUM TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CAULOPHYLLUM THALICTROIDES ROOT 30 [hp_X]/g N 20181231 0360-0110_4b80acd4-cf5f-49b0-e054-00144ff8d46c 0360-0110 HUMAN OTC DRUG CAULOPHYLLUM CAULOPHYLLUM TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CAULOPHYLLUM THALICTROIDES ROOT 6 [hp_X]/g N 20181231 0360-0114_4bd08a06-511a-0291-e054-00144ff88e88 0360-0114 HUMAN OTC DRUG CAUSTICUM CAUSTICUM TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CAUSTICUM 30 [hp_X]/g N 20181231 0360-0115_4bbdb389-c4e3-6a3c-e054-00144ff88e88 0360-0115 HUMAN OTC DRUG CAUSTICUM CAUSTICUM TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CAUSTICUM 6 [hp_X]/g N 20181231 0360-0119_4be4f8fa-704c-57fc-e054-00144ff8d46c 0360-0119 HUMAN OTC DRUG CHAMOMILLA CHAMOMILLA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY MATRICARIA CHAMOMILLA 30 [hp_X]/g N 20181231 0360-0120_4be5eac7-55c1-4bd0-e054-00144ff88e88 0360-0120 HUMAN OTC DRUG CHAMOMILLA CHAMOMILLA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY MATRICARIA CHAMOMILLA 6 [hp_X]/g N 20181231 0360-0122_4c096ca6-f80f-1b62-e054-00144ff88e88 0360-0122 HUMAN OTC DRUG CHELIDONIUM MAJUS CHELIDONIUM MAJ. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CHELIDONIUM MAJUS 30 [hp_X]/g N 20181231 0360-0123_4c080700-d69a-6004-e054-00144ff88e88 0360-0123 HUMAN OTC DRUG CHELIDONIUM MAJUS CHELIDONIUM MAJ. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CHELIDONIUM MAJUS 6 [hp_X]/g N 20181231 0360-0128_4c0cacce-2fe8-09f0-e054-00144ff88e88 0360-0128 HUMAN OTC DRUG CIMICIFUGA RACEMOSA CIMICIFUGA RAC. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY BLACK COHOSH 30 [hp_X]/g N 20181231 0360-0129_4c0e103f-7810-14ca-e054-00144ff8d46c 0360-0129 HUMAN OTC DRUG CIMICIFUGA RACEMOSA CIMICIFUGA RAC. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY BLACK COHOSH 6 [hp_X]/g N 20181231 0360-0131_4bf7aa2f-fe61-2f2d-e054-00144ff88e88 0360-0131 HUMAN OTC DRUG CINA CINA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ARTEMISIA CINA PRE-FLOWERING TOP 6 [hp_X]/g N 20181231 0360-0132_4c082404-5e96-5e91-e054-00144ff8d46c 0360-0132 HUMAN OTC DRUG CINA CINA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ARTEMISIA CINA PRE-FLOWERING TOP 30 [hp_X]/g N 20181231 0360-0134_4c0c9034-b8f6-41e6-e054-00144ff8d46c 0360-0134 HUMAN OTC DRUG CINCHONA OFFICINALIS CINCHONA OFF. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CINCHONA OFFICINALIS BARK 30 [hp_X]/g N 20181231 0360-0135_4c0a65eb-7f71-540c-e054-00144ff8d46c 0360-0135 HUMAN OTC DRUG CINCHONA OFFICINALIS BARK CINCHONA OFF. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CINCHONA OFFICINALIS BARK 6 [hp_X]/g N 20181231 0360-0138_4c0dee9c-8137-0fa6-e054-00144ff8d46c 0360-0138 HUMAN OTC DRUG COCCULUS INDICUS COCCULUS IND. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ANAMIRTA COCCULUS SEED 30 [hp_X]/g N 20181231 0360-0139_4bf86238-d2aa-4498-e054-00144ff8d46c 0360-0139 HUMAN OTC DRUG COCCULUS COCCULUS IND. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ANAMIRTA COCCULUS SEED 6 [hp_X]/g N 20181231 0360-0142_4c094981-a7a4-1c9d-e054-00144ff8d46c 0360-0142 HUMAN OTC DRUG COFFEA CRUDA COFFEA CRUDA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ARABICA COFFEE BEAN 30 [hp_X]/g N 20181231 0360-0143_4c08aba0-97df-0439-e054-00144ff88e88 0360-0143 HUMAN OTC DRUG COFFEA CRUDA COFFEA CRUDA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ARABICA COFFEE BEAN 6 [hp_X]/g N 20181231 0360-0145_4c0d5849-951f-1958-e054-00144ff88e88 0360-0145 HUMAN OTC DRUG COLOCYNTHIS COLOCYNTHIS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CITRULLUS COLOCYNTHIS FRUIT PULP 30 [hp_X]/g N 20181231 0360-0146_4c0da104-fa99-0073-e054-00144ff8d46c 0360-0146 HUMAN OTC DRUG COLOCYNTHIS COLOCYNTHIS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CITRULLUS COLOCYNTHIS FRUIT PULP 6 [hp_X]/g N 20181231 0360-0147_4c4970cc-eafa-37ec-e054-00144ff8d46c 0360-0147 HUMAN OTC DRUG CONIUM MACULATUM CONIUM MAC. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CONIUM MACULATUM FLOWERING TOP 30 [hp_X]/g N 20181231 0360-0148_4c4856b1-8624-452e-e054-00144ff88e88 0360-0148 HUMAN OTC DRUG CONIUM MACULATUM CONIUM MAC. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CONIUM MACULATUM FLOWERING TOP 6 [hp_X]/g N 20181231 0360-0150_4c6fdc2d-5c9a-3516-e054-00144ff88e88 0360-0150 HUMAN OTC DRUG CUPRUM METALLICUM CUPRUM MET. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY COPPER 30 [hp_X]/g N 20181231 0360-0151_4c71f0c4-37a1-05ab-e054-00144ff88e88 0360-0151 HUMAN OTC DRUG CUPRUM METALLICUM CUPRUM MET. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY COPPER 6 [hp_X]/g N 20181231 0360-0156_4c48b2ea-6a61-4f82-e054-00144ff88e88 0360-0156 HUMAN OTC DRUG DROSERA DROSERA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY DROSERA ANGLICA 6 [hp_X]/g N 20181231 0360-0157_4c8683f3-6602-51db-e054-00144ff8d46c 0360-0157 HUMAN OTC DRUG DROSERA DROSERA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY DROSERA ANGLICA 6 [hp_X]/g N 20181231 0360-0159_4c6d6ec3-a3fc-670c-e054-00144ff88e88 0360-0159 HUMAN OTC DRUG DULCAMARA DULCAMARA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SOLANUM DULCAMARA TOP 30 [hp_X]/g N 20181231 0360-0160_4c717b0f-02ad-464e-e054-00144ff8d46c 0360-0160 HUMAN OTC DRUG DULCAMARA DULCAMARA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SOLANUM DULCAMARA TOP 6 [hp_X]/g N 20181231 0360-0162_4cd3145f-8992-3df8-e054-00144ff88e88 0360-0162 HUMAN OTC DRUG ECHINACEA ANGUSTIFOLIA ECHINACEA ANGUST. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ECHINACEA ANGUSTIFOLIA 30 [hp_X]/g N 20181231 0360-0163_4c98aaf5-c2e3-31b8-e054-00144ff88e88 0360-0163 HUMAN OTC DRUG ECHINACEA ANGUSTIFOLIA ECHINACEA ANGUST. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ECHINACEA ANGUSTIFOLIA 6 [hp_X]/g N 20181231 0360-0167_4c4970cc-eaf5-37ec-e054-00144ff8d46c 0360-0167 HUMAN OTC DRUG EUPATORIUM PERFOLIATUM EUPATORIUM PERF. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY EUPATORIUM PERFOLIATUM FLOWERING TOP 30 [hp_X]/g N 20181231 0360-0168_4c6f8236-17fb-633f-e054-00144ff8d46c 0360-0168 HUMAN OTC DRUG EUPATORIUM PERFOLIATUM EUPATORIUM PERF. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X]/g N 20181231 0360-0172_4c71d243-24d3-5a39-e054-00144ff8d46c 0360-0172 HUMAN OTC DRUG EUPHRASIA OFFICINALIS EUPHRASIA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY EUPHRASIA STRICTA 6 [hp_X]/g N 20181231 0360-0177_4f5a9353-3be5-15d3-e054-00144ff88e88 0360-0177 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERRUM PHOS. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY FERRUM PHOSPHORICUM 30 [hp_X]/g N 20181231 0360-0179_4fab5cff-ea4d-584d-e054-00144ff88e88 0360-0179 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERRUM PHOS. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY FERRUM PHOSPHORICUM 6 [hp_X]/g N 20181231 0360-0182_4cff163a-89e8-6297-e054-00144ff8d46c 0360-0182 HUMAN OTC DRUG GELSEMIUM SEMPERVIRENS Gelsemium Semp TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY GELSEMIUM SEMPERVIRENS ROOT 30 [hp_X]/g N 20181231 0360-0183_4cfdf917-b288-234f-e054-00144ff8d46c 0360-0183 HUMAN OTC DRUG GELSEMIUM SEMPERVIRENS Gelsemium Semp TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]/g N 20181231 0360-0188_4d121cec-a94a-25ea-e054-00144ff88e88 0360-0188 HUMAN OTC DRUG GRAPHITES GRAPHITES TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY GRAPHITE 30 [hp_X]/g N 20181231 0360-0189_4d6035f5-6473-25a0-e054-00144ff88e88 0360-0189 HUMAN OTC DRUG GRAPHITES GRAPHITES TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY GRAPHITE 6 [hp_X]/g N 20181231 0360-0194_4cfe6210-22b9-36a7-e054-00144ff8d46c 0360-0194 HUMAN OTC DRUG HAMAMELIS VIRGINIANA HAMAMELIS VIRG. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 30 [hp_X]/g N 20181231 0360-0195_4cd76660-1cef-097d-e054-00144ff8d46c 0360-0195 HUMAN OTC DRUG HAMAMELIS VIRGINIANA HAMAMELIS VIRG. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6 [hp_X]/g N 20181231 0360-0200_4cfee57e-aa4a-3ea6-e054-00144ff8d46c 0360-0200 HUMAN OTC DRUG HEPAR SULPH CALC HEPAR SULPH. CALC. TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CALCIUM SULFIDE 30 [hp_X]/g N 20181231 0360-0201_4d13123a-a13f-4377-e054-00144ff88e88 0360-0201 HUMAN OTC DRUG HEPAR SULPH CALC HEPAR SULPH CALC TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY CALCIUM SULFIDE 6 [hp_X]/g N 20181231 0360-0203_4cfd5377-0b74-5429-e054-00144ff88e88 0360-0203 HUMAN OTC DRUG HYDRASTIS CAN HYDRASTIS CAN TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY GOLDENSEAL 30 [hp_X]/g N 20181231 0360-0204_4d6105b0-b3c1-43e5-e054-00144ff8d46c 0360-0204 HUMAN OTC DRUG HYDRASTIS CAN HYDRASTIS CAN TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY GOLDENSEAL 6 [hp_X]/g N 20181231 0360-0210_4cfeabd3-38ea-40d9-e054-00144ff8d46c 0360-0210 HUMAN OTC DRUG HYPERICUM PERFORATUM HYPERICUM PERF TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY HYPERICUM PERFORATUM 30 [hp_X]/g N 20181231 0360-0211_4d123293-487b-3391-e054-00144ff8d46c 0360-0211 HUMAN OTC DRUG HYPERICUM PERFORATUM HYPERICUM PERF TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY HYPERICUM PERFORATUM 6 [hp_X]/g N 20181231 0360-0215_4d61d5a3-699f-5c3e-e054-00144ff88e88 0360-0215 HUMAN OTC DRUG IGNATIA AMARA IGNATIA AMARA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY STRYCHNOS IGNATII SEED 30 [hp_X]/g N 20181231 0360-0216_4d13520b-a546-4a48-e054-00144ff88e88 0360-0216 HUMAN OTC DRUG IGNATIA AMARA IGNATIA AMARA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY STRYCHNOS IGNATII SEED 6 [hp_X]/g N 20181231 0360-0219_4d61d64d-f6f9-6a32-e054-00144ff8d46c 0360-0219 HUMAN OTC DRUG IPECACUANHA IPECACUANHA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY IPECAC 30 [hp_X]/g N 20181231 0360-0220_4d62bc16-2372-1ed6-e054-00144ff8d46c 0360-0220 HUMAN OTC DRUG IPECACUANHA IPECACUANHA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY IPECAC 6 [hp_X]/g N 20181231 0360-0225_4d8b734b-9f72-55a4-e054-00144ff8d46c 0360-0225 HUMAN OTC DRUG KALI BICHROMICUM KALI BICHR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY POTASSIUM DICHROMATE 30 [hp_X]/g N 20181231 0360-0227_4d8b734b-9f5d-55a4-e054-00144ff8d46c 0360-0227 HUMAN OTC DRUG KALI BICHROMICUM KALI BICHR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY POTASSIUM DICHROMATE 6 [hp_X]/g N 20181231 0360-0228_4d636c18-a5a7-3e94-e054-00144ff8d46c 0360-0228 HUMAN OTC DRUG KALI CARBONICUM KALI CARB TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY POTASSIUM CARBONATE 6 [hp_X]/g N 20181231 0360-0229_4d778687-aeed-4c93-e054-00144ff88e88 0360-0229 HUMAN OTC DRUG KALI CARB KALI CARB TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY POTASSIUM CARBONATE 30 [hp_X]/g N 20181231 0360-0233_4f43ca14-d463-0a66-e054-00144ff8d46c 0360-0233 HUMAN OTC DRUG KALI MURIATICUM KALI MUR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY POTASSIUM CHLORIDE 30 [hp_X]/g N 20181231 0360-0235_4f5a6a43-f57b-0f3e-e054-00144ff88e88 0360-0235 HUMAN OTC DRUG KALI MURIATICUM KALI MUR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY POTASSIUM CHLORIDE 6 [hp_X]/g N 20181231 0360-0237_504a78ca-4308-2877-e054-00144ff88e88 0360-0237 HUMAN OTC DRUG KALI PHOSPHORICUM KALI PHOS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY DIBASIC POTASSIUM PHOSPHATE 30 [hp_X]/g N 20181231 0360-0239_504b36fb-83c6-26e3-e054-00144ff8d46c 0360-0239 HUMAN OTC DRUG KALI PHOSPHORICUM KALI PHOS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY DIBASIC POTASSIUM PHOSPHATE 6 [hp_X]/g N 20181231 0360-0241_505b20b7-6633-1eef-e054-00144ff88e88 0360-0241 HUMAN OTC DRUG KALI SULPHURICUM KALI SULPH TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY POTASSIUM SULFATE 30 [hp_X]/g N 20181231 0360-0243_504c1ada-607b-4d49-e054-00144ff8d46c 0360-0243 HUMAN OTC DRUG KALI SULPHURICUM KALI SULPH TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY POTASSIUM SULFATE 6 [hp_X]/g N 20181231 0360-0245_4d785380-bef1-6f54-e054-00144ff8d46c 0360-0245 HUMAN OTC DRUG LACHESIS MUTUS LACHESIS MUTA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY LACHESIS MUTA VENOM 12 [hp_X]/g N 20181231 0360-0247_4d86b96e-88d6-60a3-e054-00144ff8d46c 0360-0247 HUMAN OTC DRUG LACHESIS MUTA LACHESIS MUTA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY LACHESIS MUTA VENOM 30 [hp_X]/g N 20181231 0360-0251_4d8a1cf8-cbf6-530b-e054-00144ff88e88 0360-0251 HUMAN OTC DRUG LEDUM PALUSTRE LEDUM PAL TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY LEDUM PALUSTRE TWIG 30 [hp_X]/g N 20181231 0360-0252_4d894245-3949-65be-e054-00144ff8d46c 0360-0252 HUMAN OTC DRUG LEDUM PALUSTRE LEDUM PAL TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY LEDUM PALUSTRE TWIG 6 [hp_X]/g N 20181231 0360-0254_4d8a85ee-5eed-62d7-e054-00144ff88e88 0360-0254 HUMAN OTC DRUG LOBELIA INFLATA LOBELIA INFLATA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY LOBELIA INFLATA 30 [hp_X]/g N 20181231 0360-0255_4d8a5de0-23f5-5bff-e054-00144ff88e88 0360-0255 HUMAN OTC DRUG LOBELIA INFLATA LOBELIA INFLATA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY LOBELIA INFLATA 6 [hp_X]/g N 20181231 0360-0259_4d8b1b6d-5c45-46a1-e054-00144ff8d46c 0360-0259 HUMAN OTC DRUG LYCOPODIUM CLAVATUM LYCOPODIUM CLAV TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY LYCOPODIUM CLAVATUM SPORE 30 [hp_X]/g N 20181231 0360-0260_4d8aeaba-ddb4-6f74-e054-00144ff88e88 0360-0260 HUMAN OTC DRUG LYCOPODIUM CLAVATUM LYCOPODIUM CLAV TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY LYCOPODIUM CLAVATUM SPORE 6 [hp_X]/g N 20181231 0360-0263_505f94fb-46f3-0fff-e054-00144ff8d46c 0360-0263 HUMAN OTC DRUG MAGNESIA PHOSPHORICA MAGNESIA PHOS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 30 [hp_X]/g N 20181231 0360-0265_50605bca-4f48-66c5-e054-00144ff88e88 0360-0265 HUMAN OTC DRUG MAGNESIA PHOSPHORICA MAGNESIA PHOS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X]/g N 20181231 0360-0268_4d9c80a2-9b99-5948-e054-00144ff88e88 0360-0268 HUMAN OTC DRUG MERCURIUS SOLUBILIS MERC VIV TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY MERCURIUS SOLUBILIS 30 [hp_X]/g N 20181231 0360-0275_50c2220b-558b-6b73-e054-00144ff8d46c 0360-0275 HUMAN OTC DRUG NATRUM MURIATICUM NATRUM MUR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SODIUM CHLORIDE 30 [hp_X]/g N 20181231 0360-0277_50c0f589-2c0f-31f8-e054-00144ff8d46c 0360-0277 HUMAN OTC DRUG NATRUM MURIATICUM NATRUM MUR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SODIUM CHLORIDE 6 [hp_X]/g N 20181231 0360-0279_50c3a7ee-04da-363b-e054-00144ff88e88 0360-0279 HUMAN OTC DRUG NATRUM PHOSPHORICUM NATRUM PHOS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 30 [hp_X]/g N 20181231 0360-0281_50c29846-3423-0310-e054-00144ff8d46c 0360-0281 HUMAN OTC DRUG NATRUM PHOSPHORICUM NATRUM PHOS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6 [hp_X]/g N 20181231 0360-0283_50c4ce46-6b14-5d0f-e054-00144ff88e88 0360-0283 HUMAN OTC DRUG NATRUM SULPHURICUM NATRUM SULPH TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SODIUM SULFATE 30 [hp_X]/g N 20181231 0360-0285_50c50da4-1ba5-6b82-e054-00144ff8d46c 0360-0285 HUMAN OTC DRUG NATRUM SULPHURICUM NATRUM SULPH TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SODIUM SULFATE 6 [hp_X]/g N 20181231 0360-0293_4d9ef14a-4824-4fcf-e054-00144ff8d46c 0360-0293 HUMAN OTC DRUG NUX VOMICA NUX VOMICA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY STRYCHNOS NUX-VOMICA SEED 30 [hp_X]/g N 20181231 0360-0294_4d9e12a7-92b9-2299-e054-00144ff8d46c 0360-0294 HUMAN OTC DRUG NUX VOMICA NUX VOMICA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY STRYCHNOS NUX-VOMICA SEED 6 [hp_X]/g N 20181231 0360-0296_4d9fd880-aa44-0aea-e054-00144ff8d46c 0360-0296 HUMAN OTC DRUG PASSIFLORA INCAR PASSIFLORA INCAR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY PASSIFLORA INCARNATA FLOWERING TOP 30 [hp_X]/g N 20181231 0360-0297_4d9f6f02-ffa2-6aa3-e054-00144ff8d46c 0360-0297 HUMAN OTC DRUG PASSIFLORA INCAR PASSIFLORA INCAR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY PASSIFLORA INCARNATA FLOWERING TOP 6 [hp_X]/g N 20181231 0360-0301_4da034b2-e744-16e5-e054-00144ff8d46c 0360-0301 HUMAN OTC DRUG PHOSPHORUS PHOSPHORUS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY PHOSPHORUS 12 [hp_X]/g N 20181231 0360-0304_4daec9c2-8d98-57d0-e054-00144ff88e88 0360-0304 HUMAN OTC DRUG PHOSPHORUS PHOSPHORUS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY PHOSPHORUS 30 [hp_X]/g N 20181231 0360-0305_4da00cd5-959d-512d-e054-00144ff88e88 0360-0305 HUMAN OTC DRUG PHOSPHORUS PHOSPHORUS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMAPNY PHOSPHORUS 6 [hp_X]/g N 20181231 0360-0306_4daec9c2-8db8-57d0-e054-00144ff88e88 0360-0306 HUMAN OTC DRUG PHYTOLACCA PHYTOLACCA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY PHYTOLACCA AMERICANA ROOT 6 [hp_X]/g N 20181231 0360-0308_4daf39ce-5c79-216a-e054-00144ff8d46c 0360-0308 HUMAN OTC DRUG PHYTOLACCA PHYTOLACCA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY PHYTOLACCA AMERICANA ROOT 30 [hp_X]/g N 20181231 0360-0310_4db01075-e267-48cd-e054-00144ff8d46c 0360-0310 HUMAN OTC DRUG PLUMBUM PLUMBUM TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY LEAD 6 [hp_X]/g N 20181231 0360-0312_4db2857b-8e2b-564f-e054-00144ff88e88 0360-0312 HUMAN OTC DRUG PLUMBUM MET PLUMBUM MET TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY LEAD 30 [hp_X]/g N 20181231 0360-0313_4db2a5d4-7b87-5a52-e054-00144ff88e88 0360-0313 HUMAN OTC DRUG PODOPHYLLUM PODOPHYLLUM PELT TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY PODOPHYLLUM 6 [hp_X]/g N 20181231 0360-0315_4db375f0-2718-7200-e054-00144ff88e88 0360-0315 HUMAN OTC DRUG PODOPHYLLUM PODOPHYLLUM PELT TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY PODOPHYLLUM 30 [hp_X]/g N 20181231 0360-0319_4deb2a1f-8c29-09fd-e054-00144ff8d46c 0360-0319 HUMAN OTC DRUG PULSATILLA NIG PULSATILLA NIG TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY PULSATILLA VULGARIS 30 [hp_X]/g N 20181231 0360-0320_4dec8f3b-bcc3-506a-e054-00144ff88e88 0360-0320 HUMAN OTC DRUG PULSATILLA NIG PULSATILLA NIG TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY PULSATILLA VULGARIS 6 [hp_X]/g N 20181231 0360-0326_4df08b5d-6397-5b08-e054-00144ff88e88 0360-0326 HUMAN OTC DRUG RHUS TOX RHUS TOX TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY TOXICODENDRON PUBESCENS LEAF 30 [hp_X]/g N 20181231 0360-0327_4df05132-e1b7-1e68-e054-00144ff8d46c 0360-0327 HUMAN OTC DRUG RHUS TOX RHUS TOX TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY TOXICODENDRON PUBESCENS LEAF 6 [hp_X]/g N 20181231 0360-0332_4ded8ef1-fa0d-73d7-e054-00144ff88e88 0360-0332 HUMAN OTC DRUG RUTA GRAVEOLENS RUTA GRAV TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY RUTA GRAVEOLENS FLOWERING TOP 30 [hp_X]/g N 20181231 0360-0333_4decaf3a-f207-27aa-e054-00144ff88e88 0360-0333 HUMAN OTC DRUG RUTA GRAVEOLENS RUTA GRAV TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X]/g N 20181231 0360-0336_4df0c2a8-291e-5f28-e054-00144ff88e88 0360-0336 HUMAN OTC DRUG SABAL SERRULATA SABAL SERR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SAW PALMETTO 6 [hp_X]/g N 20181231 0360-0342_4e0291a4-1647-4660-e054-00144ff8d46c 0360-0342 HUMAN OTC DRUG SEPIA SEPIA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SEPIA OFFICINALIS JUICE 30 [hp_X]/g N 20181231 0360-0343_4df087e3-ea7f-551d-e054-00144ff88e88 0360-0343 HUMAN OTC DRUG SEPIA SEPIA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SEPIA OFFICINALIS JUICE 6 [hp_X]/g N 20181231 0360-0347_50d853fa-cd96-488a-e054-00144ff88e88 0360-0347 HUMAN OTC DRUG SILICON DIOXIDE SILICEA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SILICON DIOXIDE 30 [hp_X]/g N 20181231 0360-0349_50d7e350-1d63-1108-e054-00144ff8d46c 0360-0349 HUMAN OTC DRUG SILICON DIOXIDE SILICEA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SILICON DIOXIDE 6 [hp_X]/g N 20181231 0360-0350_4dede44b-a325-077a-e054-00144ff88e88 0360-0350 HUMAN OTC DRUG SANGUINARIA CANADENSIS SANGUINARIA CAN TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SANGUINARIA CANADENSIS ROOT 6 [hp_X]/g N 20181231 0360-0351_4e02c90f-ca7c-61e5-e054-00144ff88e88 0360-0351 HUMAN OTC DRUG SPIGELIA ANTHELMIA Spigelia Anth TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SPIGELIA ANTHELMIA 6 [hp_X]/g N 20181231 0360-0353_4e039566-4c05-6591-e054-00144ff8d46c 0360-0353 HUMAN OTC DRUG SPIGELIA ANTHELMIA Spigelia Anth TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SPIGELIA ANTHELMIA 30 [hp_X]/g N 20181231 0360-0356_4e042f5b-3ee7-1830-e054-00144ff88e88 0360-0356 HUMAN OTC DRUG SPONGIA TOSTA SPONGIA TOSTA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_X]/g N 20181231 0360-0357_4e189a51-774e-6122-e054-00144ff88e88 0360-0357 HUMAN OTC DRUG SPONGIA TOSTA SPONGIA TOSTA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SPONGIA OFFICINALIS SKELETON, ROASTED 6 [hp_X]/g N 20181231 0360-0360_4e18de7b-0c1e-6924-e054-00144ff88e88 0360-0360 HUMAN OTC DRUG STAPHYSAGRIA STAPHYSAGRIA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY DELPHINIUM STAPHISAGRIA SEED 30 [hp_X]/g N 20181231 0360-0361_4e18eabd-32f0-3829-e054-00144ff8d46c 0360-0361 HUMAN OTC DRUG STAPHYSAGRIA STAPHYSAGRIA TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY DELPHINIUM STAPHISAGRIA SEED 6 [hp_X]/g N 20181231 0360-0362_5cf01bed-da69-f046-e053-2a91aa0a2175 0360-0362 HUMAN OTC DRUG STRAMONIUM STRAMONIUM TABLET ORAL 19970217 UNAPPROVED HOMEOPATHIC Standard Homeopathic Company DATURA STRAMONIUM 6 [hp_X]/1 N 20181231 0360-0363_5e1d32ac-740b-9ee9-e053-2991aa0a949a 0360-0363 HUMAN OTC DRUG STRAMONIUM STRAMONIUM TABLET ORAL 19970217 UNAPPROVED HOMEOPATHIC Standard Homeopathic Company DATURA STRAMONIUM 30 [hp_X]/1 N 20181231 0360-0368_4e2a8c51-3725-3dea-e054-00144ff8d46c 0360-0368 HUMAN OTC DRUG SULPHUR SULPHOR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SULFUR 30 [hp_X]/g N 20181231 0360-0369_4e2b396a-cfd3-602b-e054-00144ff8d46c 0360-0369 HUMAN OTC DRUG SULPHUR SULPHUR TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY SULFUR 6 [hp_X]/g N 20181231 0360-0373_4e2bd98e-fd3f-036e-e054-00144ff88e88 0360-0373 HUMAN OTC DRUG SYMPHYTUM OFF SYMPHYTUM OFF TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY COMFREY ROOT 30 [hp_X]/g N 20181231 0360-0374_4e2b6881-58b9-6963-e054-00144ff88e88 0360-0374 HUMAN OTC DRUG SYMPHYTUM OFF SYMPHYTUM OFF TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY COMFREY ROOT 6 [hp_X]/g N 20181231 0360-0377_4e2c10c5-336e-094f-e054-00144ff88e88 0360-0377 HUMAN OTC DRUG TABACUM TABACUM TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY TOBACCO LEAF 30 [hp_X]/g N 20181231 0360-0381_4e2c7065-03ce-158d-e054-00144ff88e88 0360-0381 HUMAN OTC DRUG THUJA OCCIDENTALIS THUJA OCCID TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_X]/g N 20181231 0360-0382_4e2c4748-7794-103e-e054-00144ff88e88 0360-0382 HUMAN OTC DRUG THUJA OCCIDENTALIS THUJA OCCID TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/g N 20181231 0360-0385_4e2cb09e-1a85-1c4f-e054-00144ff88e88 0360-0385 HUMAN OTC DRUG URTICA URENS URTICA URENS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY URTICA URENS 6 [hp_X]/g N 20181231 0360-0386_4e2d06ed-7b2e-26d5-e054-00144ff88e88 0360-0386 HUMAN OTC DRUG URTICA URENS URTICA URENS TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY URTICA URENS 30 g/g N 20181231 0360-0387_4e2d06ed-7b3f-26d5-e054-00144ff88e88 0360-0387 HUMAN OTC DRUG VALERIANA OFFICINALIS VALERIANA OFF TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY VALERIAN 6 [hp_X]/g N 20181231 0360-0388_4e3bedea-6306-2e2b-e054-00144ff88e88 0360-0388 HUMAN OTC DRUG VALERIANA OFFICINALIS VALERIANA OFF TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY VALERIAN 30 [hp_X]/g N 20181231 0360-0391_4e3bf0ee-4c45-2cee-e054-00144ff88e88 0360-0391 HUMAN OTC DRUG VERATRUM ALBUM VERATRUM ALB TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY VERATRUM ALBUM ROOT 30 [hp_X]/g N 20181231 0360-0392_4e3c6ef4-cfef-3cb4-e054-00144ff88e88 0360-0392 HUMAN OTC DRUG VERATRUM ALBUM VERATRUM ALB TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY VERATRUM ALBUM ROOT 6 [hp_X]/g N 20181231 0360-0394_4e3ce166-920a-4aa4-e054-00144ff88e88 0360-0394 HUMAN OTC DRUG ZINCUM METALLICUM ZINC MET TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ZINC 6 [hp_X]/g N 20181231 0360-0395_4e3cd47f-23d6-5e4b-e054-00144ff8d46c 0360-0395 HUMAN OTC DRUG ZINCUM METALLICUM ZINC MET TABLET SUBLINGUAL 19970217 UNAPPROVED HOMEOPATHIC STANDARD HOMEOPATHIC COMPANY ZINC 30 [hp_X]/g N 20181231 0362-0101_3d5f28db-cbe9-4f2c-9c02-8480dfc184b8 0362-0101 HUMAN PRESCRIPTION DRUG Oraverse Phentolamine Mesylate INJECTION, SOLUTION SUBMUCOSAL 20110601 NDA NDA022159 Septodont, Inc. PHENTOLAMINE MESYLATE .235 mg/mL Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0362-0122_9f15df42-2eeb-452c-9054-b3bb817fda8a 0362-0122 HUMAN OTC DRUG Projel-20 Benzocaine GEL TOPICAL 19891215 OTC MONOGRAPH FINAL part346 Septodont, Inc. BENZOCAINE 20 1/100g N 20181231 0362-0123_def86740-907d-4382-b246-602645888613 0362-0123 HUMAN OTC DRUG Projel-20 Benzocaine GEL TOPICAL 19891215 OTC MONOGRAPH FINAL part346 Septodont, Inc. BENZOCAINE 20 g/100g N 20181231 0362-0124_06de9739-8feb-45e3-a6f1-b34dcafe3a9a 0362-0124 HUMAN OTC DRUG Projel-20 Benzocaine GEL TOPICAL 19891215 OTC MONOGRAPH FINAL part346 Septodont, Inc. BENZOCAINE 20 g/100g N 20181231 0362-0125_2c74646d-7672-42fe-9a9d-b0b0e7a129ac 0362-0125 HUMAN OTC DRUG Projel-20 Benzocaine GEL TOPICAL 19891215 OTC MONOGRAPH FINAL part346 Septodont, Inc. BENZOCAINE 20 g/100g N 20181231 0362-0221_9bbc5a5c-e3b3-4d73-9e7e-ca3dbac372a2 0362-0221 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20150520 ANDA ANDA040911 Septodont, Inc. LIDOCAINE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0362-1095_fefc241d-c594-4a68-9518-e670ef12e722 0362-1095 HUMAN PRESCRIPTION DRUG Lignospan Standard Lidocaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20171128 ANDA ANDA088390 Septodont, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0362-1096_dffcd5fe-02cc-46b9-96ea-8943c24ea39b 0362-1096 HUMAN PRESCRIPTION DRUG Lignospan Forte Lidocaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20171201 ANDA ANDA088389 Septodont, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .02 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0362-1097_e8c9e464-3f9b-4489-a1dd-c18091562ef9 0362-1097 HUMAN PRESCRIPTION DRUG Scandonest 2% L Mepivacaine Hydrochloride and Levonordefrin INJECTION, SOLUTION SUBCUTANEOUS 20171218 ANDA ANDA088388 Septodont, Inc. MEPIVACAINE HYDROCHLORIDE; LEVONORDEFRIN 20; .05 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0362-1098_b3781ba5-5d38-4dca-9b04-75718c9fc4ca 0362-1098 HUMAN PRESCRIPTION DRUG Scandonest 3% Plain Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20171222 ANDA ANDA088387 Septodont, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0362-6000_f019f064-2265-4ba6-be5d-7771f1e524d5 0362-6000 HUMAN OTC DRUG SeptoSan Hand Sanitizer Alcohol LIQUID TOPICAL 20100930 OTC MONOGRAPH NOT FINAL part333E Septodont, Inc. ALCOHOL 60 L/100L E 20171231 0362-6001_f019f064-2265-4ba6-be5d-7771f1e524d5 0362-6001 HUMAN OTC DRUG SeptoSan Hand Sanitizer Alcohol LIQUID TOPICAL 20100930 OTC MONOGRAPH NOT FINAL part333E Septodont, Inc. ALCOHOL 60 L/100L E 20171231 0362-6002_f019f064-2265-4ba6-be5d-7771f1e524d5 0362-6002 HUMAN OTC DRUG SeptoSan Hand Sanitizer Alcohol LIQUID TOPICAL 20100930 OTC MONOGRAPH NOT FINAL part333E Septodont, Inc. ALCOHOL 60 L/100L E 20171231 0362-9010_63b67155-b87d-4f75-b661-8a91b8284c26 0362-9010 HUMAN PRESCRIPTION DRUG Octocaine 50 Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088389 Septodont LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .02 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 0362-9011_32ca3efb-2791-4bb8-bed9-b5cdf9b7e780 0362-9011 HUMAN PRESCRIPTION DRUG Vivacaine bupivacaine hydrochloride and epinephrine bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20130601 ANDA ANDA077250 Septodont, Inc. BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 5; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0362-9011_a0e8fd5f-b1f8-4356-a9fc-d24348155081 0362-9011 HUMAN PRESCRIPTION DRUG Vivacaine bupivacaine hydrochloride and epinephrine bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20091217 ANDA ANDA077250 Septodont Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0362-9013_e470f75b-5f30-47a1-886c-be1768920f8f 0362-9013 HUMAN PRESCRIPTION DRUG Prilocaine Hydrochloride with Epinephrine prilocaine and epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20110910 ANDA ANDA078959 Septodont Inc. PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 0362-9014_30b93d20-538b-4c99-8412-24a76b7a6e20 0362-9014 HUMAN PRESCRIPTION DRUG Prilocaine Hydrochloride prilocaine hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA079235 Septodont Inc. PRILOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 0362-9023_76664732-6976-4194-8387-02381283e329 0362-9023 HUMAN PRESCRIPTION DRUG Octocaine 100 Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 Septodont LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 0362-9048_77cb1d25-15a6-4afc-978d-02313ea73a95 0362-9048 HUMAN PRESCRIPTION DRUG Septocaine and Epinephrine Articaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20110112 NDA NDA020971 Septodont Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 0362-9049_77cb1d25-15a6-4afc-978d-02313ea73a95 0362-9049 HUMAN PRESCRIPTION DRUG Septocaine and Epinephrine Articaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20110112 NDA NDA020971 Septodont Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 0363-0003_5ced2456-e28d-4dc7-8255-a27b22b486b7 0363-0003 HUMAN OTC DRUG IBUPROFEN ibuprofen CAPSULE, LIQUID FILLED ORAL 20110509 ANDA ANDA079205 Walgreen Company IBUPROFEN 200 mg/1 N 20181231 0363-0004_cfb285a9-4953-4238-9703-acbd4ad185aa 0363-0004 HUMAN OTC DRUG Childrens WAL-DRYL Single-Use Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20110825 OTC MONOGRAPH FINAL part341 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 0363-0005_97f9d06a-c560-4b16-bbff-627ee511219e 0363-0005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Walgreen Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 0363-0006_f7a11115-99db-4093-a863-cc1836e5c822 0363-0006 HUMAN OTC DRUG Mineral Oil Lubricant Laxative mineral oil ENEMA RECTAL 20120716 OTC MONOGRAPH NOT FINAL part334 Walgreen Company MINERAL OIL 118 mL/118mL E 20171231 0363-0007_b7972f17-4a63-4d78-a181-01ea6d7d3963 0363-0007 HUMAN OTC DRUG omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150325 NDA NDA022032 Walgreen Company OMEPRAZOLE 20 mg/1 N 20181231 0363-0010_9b415007-a9fb-03b9-b8ec-5f96d120f040 0363-0010 HUMAN OTC DRUG Wal-Zan Ranitidine Hydrochloride Tablets 150mg TABLET, COATED ORAL 20110611 ANDA ANDA078192 Walgreens Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 0363-0011_2be4bf9d-9f5d-2277-e054-00144ff88e88 0363-0011 HUMAN OTC DRUG flavor chews calcium carbonate TABLET, CHEWABLE ORAL 20150323 OTC MONOGRAPH FINAL part331 Walgreens CALCIUM CARBONATE 750 mg/1 N 20181231 0363-0012_2be57d0d-f241-0dfc-e054-00144ff8d46c 0363-0012 HUMAN OTC DRUG flavor chews calcium carbonate TABLET, CHEWABLE ORAL 20150316 OTC MONOGRAPH FINAL part331 Walgreens CALCIUM CARBONATE 750 mg/1 N 20181231 0363-0014_f55b63c5-d1d8-4067-8e3a-3ac0e4ca0b3f 0363-0014 HUMAN OTC DRUG Anticavity Rinse Sodium Fluoride MOUTHWASH ORAL 20020627 OTC MONOGRAPH FINAL part355 Walgreen Co SODIUM FLUORIDE .05 kg/100L N 20191231 0363-0015_06a8db33-af4e-4342-9c43-883068ca808c 0363-0015 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20130701 OTC MONOGRAPH NOT FINAL part334 Walgreen Co MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 0363-0016_0040013d-42ae-4e98-ab8d-1d6b74bc680e 0363-0016 HUMAN OTC DRUG Stool Softener Laxative DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170831 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE SODIUM 100 mg/1 N 20181231 0363-0017_f5f049e5-c62b-4cb6-85c8-dda6284d3423 0363-0017 HUMAN OTC DRUG Salicylic acid Salicylic acid CREAM TOPICAL 20151219 OTC MONOGRAPH FINAL part333D WALGREEN COMPANY SALICYLIC ACID 5.05 mg/mL N 20181231 0363-0018_92789180-9f69-499c-a194-fdd474dc5972 0363-0018 HUMAN OTC DRUG Antibiotic Maximum Strength Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate OINTMENT TOPICAL 19980616 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 500; 3.5; 10000 [iU]/g; mg/g; [iU]/g N 20181231 0363-0019_78191c05-d13b-4e8d-bf1c-f2ba93e6841c 0363-0019 HUMAN OTC DRUG Cough Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20140210 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 0363-0020_fc207229-172b-443c-ad3d-af56fbb88aa3 0363-0020 HUMAN OTC DRUG Wal-Sleep Z Nighttime Diphenhydramine HCl LIQUID ORAL 20160912 OTC MONOGRAPH FINAL part338 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 0363-0021_60278523-53ac-1178-e053-2a91aa0a388b 0363-0021 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin, and Caffeine CAPSULE ORAL 20160810 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0363-0022_634a0966-b233-4204-ad3d-b6257403899f 0363-0022 HUMAN OTC DRUG cimetidine acid reducer Cimetidine TABLET ORAL 20010327 ANDA ANDA075285 Walgreen Company CIMETIDINE 200 mg/1 N 20181231 0363-0023_01da34b0-dafd-4342-941f-9d51e7666e69 0363-0023 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160324 OTC MONOGRAPH FINAL part331 Walgreen Company CALCIUM CARBONATE 750 mg/1 N 20181231 0363-0024_5f6d287d-29fd-498a-9f4d-fd20f97a86d5 0363-0024 HUMAN OTC DRUG 24 Hour Allergy Nasal Fluticasone propionate SPRAY, METERED NASAL 20160527 ANDA ANDA207957 Walgreen Company FLUTICASONE PROPIONATE 50 ug/1 N 20191231 0363-0025_b066ec28-24c9-42ab-8288-3079d78df99e 0363-0025 HUMAN OTC DRUG Soothe Bismuth subsalicylate LIQUID ORAL 20150131 OTC MONOGRAPH FINAL part335 Walgreens BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 0363-0026_6f3251d7-7771-44d1-8088-53553b4a0b87 0363-0026 HUMAN OTC DRUG Childrens Plus Cold Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCI SUSPENSION ORAL 20150331 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 0363-0027_8b2a9406-3727-43cf-b35c-f583ff599adb 0363-0027 HUMAN OTC DRUG Charcoal Blackhead Clearing Scrub Salicylic Acid CREAM TOPICAL 20160301 OTC MONOGRAPH FINAL part333D Walgreen Co SALICYLIC ACID 20.6 mg/mL N 20181231 0363-0029_2238dce5-3563-42d2-8c14-b2f9b8e23867 0363-0029 HUMAN OTC DRUG Cough and Sore Throat Childrens Plus Acetaminophen, Dextromethorphan hydrobromide SUSPENSION ORAL 20150430 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL N 20181231 0363-0030_b9930475-a4c3-489c-b79d-3384e18cedcf 0363-0030 HUMAN OTC DRUG Childrens Plus Flu Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, Phenylephrine HCI SUSPENSION ORAL 20150331 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 0363-0031_2b65ca6d-64b5-45e2-82bf-0da342d78e18 0363-0031 HUMAN OTC DRUG Cough Relief Daytime Nighttime dextromethorphan HBr, doxylamine succinate KIT 20120906 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-0034_515aa82f-077e-4bd9-964c-16037415a6bd 0363-0034 HUMAN OTC DRUG Childrens Plus Multi Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride SUSPENSION ORAL 20150430 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 0363-0036_c8a951cc-10ed-4b04-8b7e-89fd57676cd7 0363-0036 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20131107 ANDA ANDA090283 Walgreen Company FAMOTIDINE 20 mg/1 N 20191231 0363-0039_58516cb8-4597-44b9-a0f8-8fcd2fb7a237 0363-0039 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140731 OTC MONOGRAPH FINAL part347 Walgreens WITCH HAZEL 842 mg/mL N 20181231 0363-0040_be2f0954-23b3-4d9f-a754-8a1d08fad297 0363-0040 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20150616 ANDA ANDA074937 Walgreen Company IBUPROFEN 100 mg/5mL N 20181231 0363-0041_e77ae2d7-7331-4492-9e78-8eb4b2a9bc4e 0363-0041 HUMAN OTC DRUG Walgreen Nighttime Cold and Flu Relief acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid LIQUID ORAL 20090709 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 0363-0042_3f7330bc-63fc-98ff-ccaf-a9012ce75f4b 0363-0042 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20150901 ANDA ANDA078878 Walgreens Company OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 0363-0043_7fe8c1b9-6c35-4fef-a6f2-d4fd29c4d17d 0363-0043 HUMAN OTC DRUG Studio 35 Medicated Body Menthol POWDER TOPICAL 20140304 OTC MONOGRAPH NOT FINAL part348 Walgreen Co MENTHOL 1.5 mg/g N 20181231 0363-0045_3eaee6b8-805e-468d-8746-94cd52f0798a 0363-0045 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20000929 OTC MONOGRAPH NOT FINAL part356 Walgreens Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0363-0048_ca97d7b5-be9e-eca4-9832-9f53b0fbfb11 0363-0048 HUMAN OTC DRUG Budesonide Budesonide SPRAY, METERED NASAL 20160411 ANDA ANDA078949 Walgreens BUDESONIDE 32 ug/1 N 20181231 0363-0050_e4dc8a83-f986-43de-9f8f-b41b123edf66 0363-0050 HUMAN OTC DRUG Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, FILM COATED ORAL 20090219 ANDA ANDA079113 Walgreen Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 0363-0051_4a91f1ec-e614-47bc-94f0-e8c61e9f30c2 0363-0051 HUMAN OTC DRUG Wal Tussin CF Max Multi Symptom Cough Cold and Flu Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20160706 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 0363-0052_2e9663f7-b701-4af5-a860-9b473664cbac 0363-0052 HUMAN OTC DRUG Childrens Wal-Fex Fexofenadine Hydrochloride SUSPENSION ORAL 20141219 ANDA ANDA203330 Walgreen Company FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 0363-0055_c802cfa5-e959-4c20-a460-6044971942fb 0363-0055 HUMAN OTC DRUG Vaporizing Camphor INHALANT RESPIRATORY (INHALATION) 20090601 OTC MONOGRAPH FINAL part341 Walgreen Co CAMPHOR (SYNTHETIC) 62 mg/mL N 20191231 0363-0056_7facc15e-5882-47e3-ae70-671e8d2f7021 0363-0056 HUMAN OTC DRUG Nausea Relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20160803 UNAPPROVED DRUG OTHER Walgreen Company DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 0363-0057_692bd13f-d964-4f25-aa83-31164d711da9 0363-0057 HUMAN OTC DRUG Ibuprofen Infants ibuprofen SUSPENSION ORAL 20010413 ANDA ANDA075217 Walgreen Company IBUPROFEN 50 mg/1.25mL N 20181231 0363-0058_7a1c29a7-8362-4d94-9702-6337fe4d1898 0363-0058 HUMAN OTC DRUG Cold and Congestion Childrens Nighttime Diphenhydramine HCI, Phenylephrine HCl LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 Walgreens DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/10mL; mg/10mL N 20181231 0363-0060_cfb67ead-61f9-4d0f-b2db-792b8df3d148 0363-0060 HUMAN OTC DRUG Wal-Sleep Z Diphenhydramine HCl / Sleep Aid Diphenhydramine Hydrochloride CAPSULE, GELATIN COATED ORAL 20111208 OTC MONOGRAPH FINAL part338 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/21 N 20181231 0363-0061_2bae3ec3-03e3-4bfc-8231-48b06bbab541 0363-0061 HUMAN OTC DRUG walphed d maximum strength non drowsy sinus Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 19990924 ANDA ANDA075153 Walgreen Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20191231 0363-0062_8fa72346-2f53-4788-9f3e-5e723d92fffb 0363-0062 HUMAN OTC DRUG Magnesium Citrate Saline Laxative Magnesium citrate LIQUID ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 Walgreens MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 0363-0063_3f67b412-7cb5-47b3-b96e-05e89108f517 0363-0063 HUMAN OTC DRUG Hydrocortisone Plus Hydrocortisone CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part348 Walgreens HYDROCORTISONE 10 mg/g N 20181231 0363-0064_2b11f358-0096-4398-baa8-b6de69476842 0363-0064 HUMAN OTC DRUG Sinus Relief Congestion and Cough Maximum Strength Acetaminophen, Diphenhydramine HCI, Phenylephrine HCl LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 0363-0067_2ea38a1d-ff9a-49ed-9fbf-dd10642f22bf 0363-0067 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20080311 OTC MONOGRAPH FINAL part347 Walgreen Co LANOLIN; PETROLATUM 133; 459 mg/g; mg/g N 20181231 0363-0069_8317e191-da56-4f0f-9d30-c56adecda668 0363-0069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19950330 OTC MONOGRAPH FINAL part347 Walgreen Co PETROLATUM 1 g/g N 20181231 0363-0070_e1bc150d-98a6-4e90-ad8d-21a9416a8f5e 0363-0070 HUMAN OTC DRUG Anticavity Sodium Fluoride RINSE ORAL 20130923 OTC MONOGRAPH FINAL part355 Walgreen Co. SODIUM FLUORIDE .05 mg/mL N 20181231 0363-0071_961f4036-8abb-4011-b11b-ec9007d482fc 0363-0071 HUMAN OTC DRUG Mucus Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170821 NDA NDA021282 walgreens GUAIFENESIN 600 mg/1 N 20181231 0363-0072_5f2615e9-0d52-4b01-9eda-50a3360056df 0363-0072 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20070330 OTC MONOGRAPH NOT FINAL part348 Walgreens Co. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 0363-0073_f4947e45-5ae3-44db-9cec-b6b7876a0198 0363-0073 HUMAN OTC DRUG Soothe Bismuth subsalicylate LIQUID ORAL 20150131 OTC MONOGRAPH FINAL part335 Walgreens BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 0363-0074_4ec8061a-0a51-4746-add4-6c0d6e31433c 0363-0074 HUMAN OTC DRUG Mucus Extended Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170821 NDA NDA021282 walgreens GUAIFENESIN 1200 mg/1 N 20181231 0363-0075_ae501485-f8c1-45fe-bdec-c0da4b4d2eba 0363-0075 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20161024 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN 500 [USP'U]/g N 20181231 0363-0076_867b01e5-9839-489b-8a79-e74eaca0c1ec 0363-0076 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20170905 NDA NDA021620 walgreens GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 0363-0078_32daca21-ce4c-4496-9da9-3441c72a0ce6 0363-0078 HUMAN OTC DRUG Well at Walgreens Castor Oil Castor oil OIL ORAL 19921023 OTC MONOGRAPH NOT FINAL part334 Walgreen Co CASTOR OIL 1 mL/mL N 20181231 0363-0080_b9742419-3b20-4558-9e81-1287020a1eee 0363-0080 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130910 OTC MONOGRAPH NOT FINAL part356 Walgreen Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0363-0081_5b86db9f-b6dd-4d6a-a86c-4272430ef6ec 0363-0081 HUMAN OTC DRUG Miconazole 3 Miconazole nitrate KIT 20050701 ANDA ANDA075329 Walgreen Company N 20181231 0363-0085_c885e6bb-e305-4196-a1cf-4259298f877c 0363-0085 HUMAN OTC DRUG Sore Mouth Cleanser Hydrogen Peroxide MOUTHWASH TOPICAL 20140502 OTC MONOGRAPH NOT FINAL part333A Walgreens HYDROGEN PEROXIDE 1588 mg/mL N 20181231 0363-0086_b771ce50-62a9-4827-94b2-e33aadee30c7 0363-0086 HUMAN OTC DRUG Hemorrhoidal cooling Phenylephrine HCl, Witch hazel GEL TOPICAL 20160730 OTC MONOGRAPH FINAL part346 Walgreens PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 24.8; 497 g/g; g/g N 20181231 0363-0088_e38d2c73-7022-42ea-900c-616d272d0c10 0363-0088 HUMAN OTC DRUG Iodine Iodine LIQUID TOPICAL 20110311 OTC MONOGRAPH NOT FINAL part333A Walgreen Co IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 0363-0089_82dd2621-7917-4977-bd31-8bee10bbbdbb 0363-0089 HUMAN OTC DRUG Pain and Fever Childrens Acetaminophen LIQUID ORAL 20140530 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0091_3e2edc28-6ca2-48db-bd98-32c71b527307 0363-0091 HUMAN OTC DRUG Pain and Fever Infants Acetaminophen SUSPENSION ORAL 20140831 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0092_804c3fa3-5f3b-4188-9864-289a36945752 0363-0092 HUMAN OTC DRUG Wal Dryl Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part341 Walgreens DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 0363-0096_51e8993b-5efd-42ae-94c5-9639e5c21005 0363-0096 HUMAN OTC DRUG wal flu severe cold and cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120117 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 0363-0099_4d4e84b1-4a8a-402f-ab23-d76d475b63d4 0363-0099 HUMAN OTC DRUG Health Cetylpyridinium chloride MOUTHWASH ORAL 20070419 OTC MONOGRAPH NOT FINAL part356 Walgreen Co CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 0363-0101_abe212d4-0350-496e-ab7c-2d6bf6c2e775 0363-0101 HUMAN OTC DRUG Stop Lice Complete Lice Treatment Piperonyl butoxide, pyrethrum extract KIT 20160331 OTC MONOGRAPH FINAL part358G Walgreen Company N 20181231 0363-0104_2eccf9a7-a0bf-4a23-a6d8-c4b589bb94c2 0363-0104 HUMAN OTC DRUG Pain Reliever Regular Strength Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 325 mg/1 N 20191231 0363-0106_7ccbc7c7-e5fc-45ae-aa4f-15a013ce3977 0363-0106 HUMAN OTC DRUG Multi-Symptom Cold Warming Effect Daytime Acetaminophen, Dextromethorphan HBr, Phenylepherine CAPSULE ORAL 20120620 20180922 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 0363-0107_2c02e195-9c17-4ddc-80c2-52e51ae9eba0 0363-0107 HUMAN OTC DRUG Heartburn Plus Gas Relief Chewable Multi Symptom Calcium carbonate ,Magnesium hydroxide,Simethicone TABLET, CHEWABLE ORAL 20171218 OTC MONOGRAPH FINAL part331 WALGREEN CO. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE; DIMETHICONE 675; 135; 60 mg/1; mg/1; mg/1 N 20191231 0363-0111_a273edf6-bb88-4292-ad20-36d810118be8 0363-0111 HUMAN OTC DRUG Wal-phed Chlorpheniramine Maleate and Pseudoephedrine HCl TABLET ORAL 19921216 OTC MONOGRAPH FINAL part341 Walgreen Company CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 60 mg/1; mg/1 N 20181231 0363-0112_d7e3bc79-287a-4e9d-9b42-efe56a399b75 0363-0112 HUMAN OTC DRUG Wal-phed Pseudophedrine HCl TABLET, FILM COATED ORAL 19810825 OTC MONOGRAPH FINAL part341 Walgreen Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 0363-0113_e280f55b-6fe2-452b-b8a6-e5b98259996f 0363-0113 HUMAN OTC DRUG Walgreens Urinary Pain Relief Maximum Strength PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20100405 UNAPPROVED DRUG OTHER Walgreens Co. PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 0363-0114_603c9886-f953-6327-e053-2a91aa0aba6e 0363-0114 HUMAN OTC DRUG SEVERE NIGHTTIME COLD AND FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, GELATIN COATED ORAL 20160501 OTC MONOGRAPH FINAL part341 WALGREENS ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0363-0115_60271d4b-f5a6-a019-e053-2991aa0af1b3 0363-0115 HUMAN OTC DRUG MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM Dextromethorphan Hydrobromide and Guaifenesin CAPSULE, GELATIN COATED ORAL 20160501 OTC MONOGRAPH FINAL part341 WALGREENS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 N 20181231 0363-0117_8112d141-e253-463f-930c-744772deb156 0363-0117 HUMAN OTC DRUG well at walgreens lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 Walgreen Company LANSOPRAZOLE 15 mg/1 N 20181231 0363-0122_122909d9-119e-43fe-ad8a-8c8e665eb17a 0363-0122 HUMAN OTC DRUG Wal-dryl diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part348 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 mg/g; mg/g E 20171231 0363-0123_1bd8afaf-0012-4a7e-a143-3f056c4ee1ea 0363-0123 HUMAN OTC DRUG Triple Antibiotic with Pain Relief Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride OINTMENT TOPICAL 20140327 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g E 20171231 0363-0124_0f832064-1651-4ba1-a2ba-f5b27c7a8b75 0363-0124 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20090915 ANDA ANDA090711 Walgreen Company NICOTINE 2 mg/1 N 20181231 0363-0125_65153d48-2e09-4f53-b993-cec2c8353396 0363-0125 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20120530 OTC MONOGRAPH FINAL part347 Walgreens DIMETHICONE 180 mg/1 N 20181231 0363-0126_086fba92-75d0-4c2b-abcd-72ba10b86574 0363-0126 HUMAN OTC DRUG Oral Saline Laxative dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20121005 OTC MONOGRAPH NOT FINAL part334 Walgreen Co SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC .9; 2.4 g/15mL; g/15mL E 20171231 0363-0127_633f913c-cde6-42b6-9335-ab87bebc4404 0363-0127 HUMAN OTC DRUG Oral Saline Laxative dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20121005 OTC MONOGRAPH NOT FINAL part334 Walgreen Co SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC .9; 2.4 g/15mL; g/15mL E 20171231 0363-0129_f6067c74-0686-46bc-9b93-3984d766e882 0363-0129 HUMAN OTC DRUG Wal-Zyr 24 Hour Allergy Cetirizine HCl TABLET ORAL 20131230 ANDA ANDA078780 Walgreens CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0363-0131_a29239a1-e09c-8eac-be4b-7bb546fb68b5 0363-0131 HUMAN OTC DRUG Wal-Zan 75 Ranitidine Tablet USP, 75mg TABLET ORAL 20140106 ANDA ANDA075294 Walgreens Company RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 0363-0132_0e9fd1f8-b362-4902-9870-2d8b3e945ada 0363-0132 HUMAN OTC DRUG Pain and Fever Infants Acetaminophen LIQUID ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0137_42b2c384-c310-3ea2-e054-00144ff8d46c 0363-0137 HUMAN OTC DRUG Acne Cleansing Bar Benzoyl Peroxide SOAP TOPICAL 20161201 OTC MONOGRAPH FINAL part333D Walgreens BENZOYL PEROXIDE 100 mg/g N 20181231 0363-0140_eb19af42-9f45-4a00-94e1-77753019fd68 0363-0140 HUMAN OTC DRUG pain relief Naproxen sodium TABLET, FILM COATED ORAL 20111022 ANDA ANDA074661 Walgreen Company NAPROXEN SODIUM 220 mg/1 N 20181231 0363-0141_98c6ddc9-8103-40b3-a145-ffbe3374ab6c 0363-0141 HUMAN OTC DRUG Acid Controller Original Strength Famotidine TABLET ORAL 20090828 ANDA ANDA075400 Walgreen Company FAMOTIDINE 10 mg/1 N 20181231 0363-0144_788e5932-15f3-4115-aac8-860f5fdbd4e1 0363-0144 HUMAN OTC DRUG Mucus Relief D Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20151216 ANDA ANDA091071 Walgreen Company GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20191231 0363-0147_98a3602e-5bd2-4cc6-be00-4b6b299b37d3 0363-0147 HUMAN OTC DRUG WALGREENS COOL AND HEAT MUSCLE AND JOINT RELIEF MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20130331 OTC MONOGRAPH NOT FINAL part348 WALGREEN COMPANY MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g E 20171231 0363-0148_9aa2424d-abf7-4b8a-9fa8-f452fa388043 0363-0148 HUMAN OTC DRUG Wal-Nadol Extra Strength Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 500 mg/1 N 20181231 0363-0149_6f0db00f-2cba-4146-88d6-ff9d3b7ce982 0363-0149 HUMAN OTC DRUG WALGREENS MEDICATED PAIN RELIEVING CAMPHOR, MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20130228 OTC MONOGRAPH NOT FINAL part348 WALGREENS CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 7.1; 33; 36 mg/1; mg/1; mg/1 N 20181231 0363-0150_b413af71-fd41-4fe6-a91b-8fb14a3fda74 0363-0150 HUMAN OTC DRUG Cool n Heat Patch for Arm, Neck and Leg Extra Strength Menthol PATCH TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part348 Walgreen Co. MENTHOL .05 mg/g N 20181231 0363-0151_8f42099d-c592-4952-9905-87766928b689 0363-0151 HUMAN OTC DRUG Pain Relieving Patch Ultra Strength Menthol PATCH TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part348 Walgreen Co. MENTHOL .05 mg/g N 20181231 0363-0152_a9a1b401-911e-4504-a898-657326fa2c20 0363-0152 HUMAN OTC DRUG Cool n Heat Patch for Back Extra Strength Menthol PATCH TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part348 Walgreen Co. MENTHOL .05 mg/g N 20181231 0363-0154_2131a126-90b3-4e60-8aaf-a8844e887f7f 0363-0154 HUMAN OTC DRUG Athletes Foot tolnaftate SPRAY TOPICAL 20170706 OTC MONOGRAPH FINAL part333C Walgreen Company TOLNAFTATE 1 g/100g N 20191231 0363-0156_853f9b1d-0e68-47bf-b56c-1e35858b8044 0363-0156 HUMAN OTC DRUG Mucus Relief Severe Sinus Congestion Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130630 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 0363-0157_2f8ec415-8c10-4953-a4cb-d9b6196be618 0363-0157 HUMAN OTC DRUG Aspirin Regular Strength Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH FINAL part343 Walgreen Company ASPIRIN 325 mg/1 N 20181231 0363-0158_9a20a8e2-6581-4567-89d0-6b9980c4e606 0363-0158 HUMAN OTC DRUG walprofen congestion relief and pain Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20170706 ANDA ANDA203200 Walgreen Company IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20191231 0363-0159_cbc78792-a9a6-453e-95f9-4baa449ae165 0363-0159 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0363-0160_bcf0d84a-b66b-48b9-81e1-f94a115c6f40 0363-0160 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20120929 OTC MONOGRAPH FINAL part346 Walgreen Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g N 20181231 0363-0161_33ee2942-c45d-40a9-bb7d-41db288526d8 0363-0161 HUMAN OTC DRUG pain and fever Acetaminophen SUSPENSION ORAL 20110916 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0163_2345ed2a-5704-42ec-909b-14cbda63021b 0363-0163 HUMAN OTC DRUG Mouth Rinse sodium fluoride MOUTHWASH ORAL 20060315 OTC MONOGRAPH FINAL part355 Walgreen SODIUM FLUORIDE .1 mg/mL N 20181231 0363-0164_6dc62a46-e339-439c-95a6-9245847ef64a 0363-0164 HUMAN OTC DRUG Regular Strength Aspirin Aspirin and Caffeine TABLET, FILM COATED ORAL 20110101 20180618 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ASPIRIN; CAFFEINE 400; 32 mg/1; mg/1 E 20171231 0363-0166_b993f853-e21f-499d-b05e-a03e32826f2d 0363-0166 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020304 ANDA ANDA074937 Walgreen Company IBUPROFEN 100 mg/5mL N 20181231 0363-0168_6c191e84-6feb-4afb-b07d-82fef26d0785 0363-0168 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140331 ANDA ANDA079096 Walgreens NAPROXEN SODIUM 220 mg/1 N 20181231 0363-0169_ef61a7c4-560a-47f9-8bad-a4891ce72bcd 0363-0169 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140331 ANDA ANDA079096 Walgreens NAPROXEN SODIUM 220 mg/1 N 20181231 0363-0170_b93096ad-1c4d-4209-aa72-7a12995cd1ae 0363-0170 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20120701 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE CALCIUM 240 mg/1 N 20181231 0363-0173_07fe7321-17f8-48db-86c8-d85bc62aa1da 0363-0173 HUMAN OTC DRUG Stop Lice Complete Lice Treatment Piperonyl Butoxide, Pyrethrum Extract KIT 20071029 OTC MONOGRAPH FINAL part358G Walgreen Company N 20181231 0363-0173_aa78b19c-db29-49f8-8b88-2143845f8fc5 0363-0173 HUMAN OTC DRUG complete lice treatment kit Piperonyl Butoxide, Pyrethrum Extract KIT 20071029 OTC MONOGRAPH FINAL part358G Walgreen Company N 20181231 0363-0174_ba553d3c-42a2-48b3-bfe1-818535ab85e0 0363-0174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141031 NDA NDA021920 Walgreens NAPROXEN SODIUM 220 mg/1 N 20181231 0363-0175_ebb5897e-782a-411c-be81-2c8a7742de8c 0363-0175 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 500 mg/1 N 20191231 0363-0178_164cde82-1e11-4de2-97c3-0e25b6f63931 0363-0178 HUMAN OTC DRUG Wal-Act Pseudoephedrine HCl and Triprolidine HCl TABLET, FILM COATED ORAL 19930109 OTC MONOGRAPH FINAL part341 Walgreen Company PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 60; 2.5 mg/1; mg/1 N 20181231 0363-0179_6408cf58-c2f0-431e-b1a5-ff5a456a0fcb 0363-0179 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate OINTMENT TOPICAL 20050119 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 0363-0180_34edbae8-e952-4908-a425-b9f029bb4502 0363-0180 HUMAN OTC DRUG Senna SENNOSIDES TABLET ORAL 20120817 OTC MONOGRAPH NOT FINAL part334 Walgreens SENNOSIDES 8.6 mg/1 N 20181231 0363-0183_bcc70fb7-8306-4099-87ee-092340e009ec 0363-0183 HUMAN OTC DRUG Regular Strength Tri-Buffered Aspirin Aspirin TABLET, FILM COATED ORAL 19900330 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ASPIRIN 325 mg/1 N 20181231 0363-0184_2981c5f7-121a-4030-86b1-559061030e7a 0363-0184 HUMAN OTC DRUG Antacid Extra Strength Antacid TABLET, CHEWABLE ORAL 20171219 OTC MONOGRAPH FINAL part331 WALGREEN CO. CALCIUM CARBONATE 750 mg/1 N 20181231 0363-0188_b87b5ed4-98e0-4b84-b739-6f808b495c89 0363-0188 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140130 OTC MONOGRAPH FINAL part346 Walgreen Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 0363-0189_76b97f59-ea68-4576-862c-714ba4b9be9c 0363-0189 HUMAN OTC DRUG Sleep II Nighttime Sleep Aid Diphenhydramine HCl TABLET ORAL 19900410 OTC MONOGRAPH FINAL part338 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0363-0190_7e5a9d4f-5d23-439c-a85b-63530f80778c 0363-0190 HUMAN OTC DRUG Wal-Dryl Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0363-0192_4c2ae918-6ec0-4a43-8489-00e0a4ca01c6 0363-0192 HUMAN OTC DRUG Wal-Phed PE, Multi-Symptom, Daytime, Nighttime Acetaminophen, Dextromethorphan HBr, Guaifensin, Diphenhydramine HCl, Phenylephrine HCl KIT 20070222 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-0197_7fcbf4fd-1b9a-49fd-961a-6433d1f0af91 0363-0197 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130930 ANDA ANDA078682 Walgreens IBUPROFEN 200 mg/1 N 20181231 0363-0198_208cda58-9fad-4dcd-8e9b-0b08e3b8620e 0363-0198 HUMAN OTC DRUG Wal-Dram Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Walgreen Company DIMENHYDRINATE 50 mg/1 N 20191231 0363-0199_d850b59a-ea60-46aa-a4d7-2e42dd15ff53 0363-0199 HUMAN OTC DRUG Miconazole 1 Miconazole nitrate KIT 20100610 ANDA ANDA079114 Walgreen Company N 20181231 0363-0201_cd149c15-5546-4a39-b165-abc0d14d7ba9 0363-0201 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20100112 ANDA ANDA090821 Walgreen Company NICOTINE 2 mg/1 N 20181231 0363-0203_5ef9958c-2539-3ee4-e053-2a91aa0a04de 0363-0203 HUMAN OTC DRUG Salicylic Acid Wart Removers PATCH TOPICAL 20130726 OTC MONOGRAPH FINAL part358B Walgreens Company SALICYLIC ACID 40 mg/181 N 20181231 0363-0204_ca2fcb32-7710-4f5b-b4d4-ed64b5ec9712 0363-0204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Walgreen Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20191231 0363-0206_5e97d32a-8ffc-35fe-e053-2a91aa0aea9f 0363-0206 HUMAN OTC DRUG Undecylenic Acid Antifungal Pen LIQUID TOPICAL 20130730 OTC MONOGRAPH FINAL part333C Walgreen Company UNDECYLENIC ACID 25 mg/1.7mL N 20181231 0363-0208_53f1cc6c-4021-4256-9f2a-c50aac793b2d 0363-0208 HUMAN OTC DRUG NICOTINE Original nicotine polacrilex LOZENGE ORAL 20021031 NDA NDA021330 Walgreens NICOTINE 2 mg/1 N 20181231 0363-0209_53f1cc6c-4021-4256-9f2a-c50aac793b2d 0363-0209 HUMAN OTC DRUG NICOTINE Original nicotine polacrilex LOZENGE ORAL 20021031 NDA NDA021330 Walgreens NICOTINE 4 mg/1 N 20181231 0363-0210_5e9924be-4d68-324a-e053-2a91aa0a8ec1 0363-0210 HUMAN OTC DRUG Benzethonium chloride and Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20120112 OTC MONOGRAPH NOT FINAL part333A Walgreen Company BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .06; .23 mg/29.6mL; mg/29.6mL N 20181231 0363-0211_997032ac-0110-4004-9697-d82146ba7128 0363-0211 HUMAN OTC DRUG 24 Hour Allergy Cetirizine HCl CAPSULE ORAL 20130301 NDA NDA022429 Walgreens CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0363-0212_6f92691c-0706-48ca-a271-ecacbdceb9c1 0363-0212 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 19951013 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0213_d103ad81-efd3-4f59-b437-dbe04bf2869c 0363-0213 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130531 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0363-0215_5e9924be-4d56-324a-e053-2a91aa0a8ec1 0363-0215 HUMAN OTC DRUG Diphenhydramine HCl and Zinc Acetate Extra Strength Itch Relief SPRAY TOPICAL 20120112 OTC MONOGRAPH NOT FINAL part348 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.52; .076 g/76g; g/76g N 20181231 0363-0216_5e99c787-c598-173f-e053-2991aa0a54bf 0363-0216 HUMAN OTC DRUG Tolnaftate Odor Control Powder Spray AEROSOL, SPRAY TOPICAL 20120120 OTC MONOGRAPH FINAL part333C Walgreen Company TOLNAFTATE 1.3 g/113g N 20181231 0363-0218_ea83de76-8afc-4b76-828d-de24d09860da 0363-0218 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ASPIRIN 81 mg/1 N 20181231 0363-0219_5e99c787-c5aa-173f-e053-2991aa0a54bf 0363-0219 HUMAN OTC DRUG Salicylic Acid Wart Remover Gel GEL TOPICAL 20120824 OTC MONOGRAPH FINAL part358B Walgreen Company SALICYLIC ACID .17 g/7g N 20181231 0363-0220_eee676f1-ede8-4426-b410-33eaf7d3c1f0 0363-0220 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 19980901 ANDA ANDA074165 Walgreen Company CLOTRIMAZOLE 10 mg/g N 20181231 0363-0223_14c0e8e3-f36f-4b10-8f76-2079600ca6f4 0363-0223 HUMAN OTC DRUG Wal-Som Diphenhydramine hydrochloride TABLET ORAL 20120822 OTC MONOGRAPH FINAL part338 Walgreen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 0363-0224_a03e31f6-0035-4bd3-9cf5-f575ca5d9d58 0363-0224 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19960105 OTC MONOGRAPH FINAL part347 Walgreen Co. FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 0363-0226_edc58d70-0889-4b2e-973c-2be2f190d2d3 0363-0226 HUMAN OTC DRUG Stay Awake Maximum Strength Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 Walgreen Company CAFFEINE 200 mg/1 N 20181231 0363-0227_4fb1d0a0-13e3-40d5-ab08-82802e255805 0363-0227 HUMAN OTC DRUG Aspirin Enteric Coated, Regular Strength Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ASPIRIN 325 mg/1 N 20181231 0363-0229_026f5521-df01-488b-ba5f-a43337dee6f9 0363-0229 HUMAN OTC DRUG Acne Treatment Benzoyl peroxide GEL TOPICAL 20111202 OTC MONOGRAPH FINAL part333D Walgreens Co. BENZOYL PEROXIDE 1 mg/g N 20181231 0363-0230_6fd22cc7-72ba-40d6-a03b-6098f457c3b7 0363-0230 HUMAN OTC DRUG Maximum Strength Hydrocortisone Hydrocortisone Ointment OINTMENT TOPICAL 20160607 OTC MONOGRAPH NOT FINAL part348 Walgreens HYDROCORTISONE 1.02 g/100g N 20181231 0363-0235_34c239d4-fb58-4356-90ab-ed65e2efd62c 0363-0235 HUMAN OTC DRUG Wal-Nadol PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0363-0236_a7d04f92-38dc-47fa-a1be-2e12efcca875 0363-0236 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Walgreens DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 0363-0237_7e17efc7-f30c-4b7b-ae9f-5d3d62066a4f 0363-0237 HUMAN OTC DRUG Hydrocortisone Cream Intensive Healing Hydrocortisone Cream CREAM TOPICAL 20160607 OTC MONOGRAPH NOT FINAL part348 Walgreens HYDROCORTISONE 1.02 g/100g N 20181231 0363-0238_c8b771a3-0ebe-4efc-b1cb-b640cc51fad9 0363-0238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE SODIUM 100 mg/1 N 20181231 0363-0239_dc9de73f-024f-4757-a432-28e567c2bf4d 0363-0239 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE SODIUM 100 mg/1 N 20181231 0363-0243_c03af79f-4561-46e3-bc74-97da3debb096 0363-0243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20120404 OTC MONOGRAPH FINAL part333A Walgreen Co TRICLOSAN .15 kg/100L N 20181231 0363-0244_644af0a0-77d1-498d-b393-408c30daa374 0363-0244 HUMAN OTC DRUG Non-Drowsy Formula Wal-Tussin Dextromethorphan HBr CAPSULE, GELATIN COATED ORAL 20060424 20180827 OTC MONOGRAPH FINAL part341 WALGREEN CO. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 E 20171231 0363-0246_952c3f32-05ce-4fd9-80f8-ee16ab16473b 0363-0246 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20131030 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0363-0247_9eebf373-c452-4d18-be0d-488d7f18eca3 0363-0247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140930 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0363-0248_e775c809-5e0a-4cdd-93cd-00a2fa118cba 0363-0248 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090123 OTC MONOGRAPH FINAL part341 Walgreen CO CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg N 20181231 0363-0252_3472a9ad-03f5-40c0-9577-cfc79868e47a 0363-0252 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20191231 0363-0253_b18ee178-3ea7-45a2-a13b-d23276591ddb 0363-0253 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20160531 OTC MONOGRAPH FINAL part358H Walgreen Co PYRITHIONE ZINC 10 mg/mL N 20181231 0363-0255_e8541364-d649-42e9-9e41-e3201ba10433 0363-0255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20050513 ANDA ANDA075217 Walgreen Company IBUPROFEN 50 mg/1.25mL N 20181231 0363-0257_2ae291b4-4ce8-4c6b-a666-889c7f3ecabd 0363-0257 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20140731 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE CALCIUM 240 mg/1 N 20181231 0363-0264_75409a6c-757b-4cd9-bb07-5e6916f333c1 0363-0264 HUMAN OTC DRUG Daily Acne Control Cleanser Benzoyl peroxide CREAM TOPICAL 20160301 OTC MONOGRAPH FINAL part333D Walgreen Co BENZOYL PEROXIDE 104 mg/10g N 20181231 0363-0267_a7f378e8-50f4-4629-bd92-04ed914323f6 0363-0267 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20170630 OTC MONOGRAPH NOT FINAL part333A Walgreens HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 0363-0268_32afc75a-813b-4e63-a063-e7366b578a8b 0363-0268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20150430 OTC MONOGRAPH NOT FINAL part356 Walgreens HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 0363-0275_7e88cd6a-3667-4ac1-adff-710c54e57b9b 0363-0275 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20170630 OTC MONOGRAPH NOT FINAL part333A Walgreens ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 0363-0276_d7524de7-4230-4cb1-8224-7457a64710d4 0363-0276 HUMAN OTC DRUG wal zyr Cetirizine Hydrochloride SOLUTION ORAL 20151212 ANDA ANDA090254 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0363-0277_38fc735c-66d0-4b68-bffe-3c5c7a77ff3e 0363-0277 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20150430 OTC MONOGRAPH NOT FINAL part333A Walgreens ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 0363-0278_4ed9f40e-5e7e-4cf1-901f-9437d588e5ed 0363-0278 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen LIQUID ORAL 20160131 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 500 mg/15mL N 20181231 0363-0279_ec2e19ad-08b3-4720-aa91-236546875857 0363-0279 HUMAN OTC DRUG Hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140926 OTC MONOGRAPH FINAL part346 Walgreen Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 0363-0281_15bd58ca-048b-45ad-b744-54df3e710372 0363-0281 HUMAN OTC DRUG Pain and Fever Childrens Acetaminophen LIQUID ORAL 20140530 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0283_1962b469-0ce0-4a4c-8080-6fb7a5662882 0363-0283 HUMAN OTC DRUG Dye Free Pain and Fever Childrens Acetaminophen SUSPENSION ORAL 20150331 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0284_b470660c-1aee-4403-8295-05b4264ac2cb 0363-0284 HUMAN OTC DRUG Dye Free Pain and Fever Childrens Acetaminophen SUSPENSION ORAL 20151231 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0285_6b06db20-ba8b-47ff-a30f-d56ffe14ed6d 0363-0285 HUMAN OTC DRUG Dye Free Pain and Fever Childrens Acetaminophen SUSPENSION ORAL 20150331 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0288_fea8bb8f-e30e-46d6-b8b7-2a81e341e143 0363-0288 HUMAN OTC DRUG childrens chest congestion Guaifenesin SOLUTION ORAL 20070830 OTC MONOGRAPH FINAL part341 Walgreen Company GUAIFENESIN 100 mg/5mL N 20181231 0363-0291_2276dfa1-4893-4696-ad6e-2abbb5337f57 0363-0291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Walgreen Company IBUPROFEN 200 mg/1 N 20181231 0363-0292_1ccabf09-62ba-4a6e-91e0-6dda34db7d19 0363-0292 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Walgreen Company IBUPROFEN 200 mg/1 N 20181231 0363-0293_96c6388a-0008-4a4b-b74b-616865320b3d 0363-0293 HUMAN OTC DRUG Dye Free Wal Dryl Allergy childrens Diphenhydramine Hydrochloride LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Walgreens DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 0363-0294_84cb99a4-38ec-4e48-b96d-d01964abf10b 0363-0294 HUMAN OTC DRUG minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20120301 ANDA ANDA091344 Walgreen Company MINOXIDIL 5 g/100g N 20181231 0363-0295_5988d464-9d49-40d8-9b7c-5e00b453c12e 0363-0295 HUMAN OTC DRUG Anti-Itch Wal-Dryl Diphenhydramine HCl, Zinc Acetate SPRAY TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part348 Walgreen's Co DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 kg/100L; kg/100L N 20181231 0363-0297_0704ace8-328a-4a42-a55c-7b5445ab13b9 0363-0297 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide SUSPENSION ORAL 20150731 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 0363-0299_92e767ee-e0ef-4b05-8af7-03dc1bb267fa 0363-0299 HUMAN OTC DRUG wal itin d non drowsy 24 hour allergy and congestion Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20030604 ANDA ANDA075706 Walgreen Company PSEUDOEPHEDRINE SULFATE; LORATADINE 240; 10 mg/1; mg/1 N 20181231 0363-0300_568b0af4-0c9f-4601-adf8-f453397bdc36 0363-0300 HUMAN OTC DRUG Adult Wal Tussin Cough Long Acting Dextromethorphan Hydrobromide SOLUTION ORAL 20040903 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL N 20191231 0363-0304_31778fdc-0c4a-49eb-8d68-3ae54a258670 0363-0304 HUMAN OTC DRUG Anefrin Nasal Original oxymetazoline hydrochloride SPRAY NASAL 19950928 OTC MONOGRAPH FINAL part341 Walgreen Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20191231 0363-0306_a94b235b-4df5-440d-94aa-b52f1584f813 0363-0306 HUMAN OTC DRUG smooth lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091009 ANDA ANDA090685 Walgreen Company POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 0363-0307_c816e31d-e80e-4e32-9d84-f5d2e389fe80 0363-0307 HUMAN OTC DRUG Lubricant Eye Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20130426 OTC MONOGRAPH FINAL part349 Walgreens POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 0363-0310_94a7cb5c-a2d0-4807-940b-0e5a5e8ced05 0363-0310 HUMAN OTC DRUG wal tussin adult chest congestion Guaifenesin SOLUTION ORAL 19951013 OTC MONOGRAPH FINAL part341 Walgreen Company GUAIFENESIN 200 mg/10mL N 20181231 0363-0312_8953900a-93dd-4add-ab55-fecf229b246d 0363-0312 HUMAN OTC DRUG Childrens Wal Tap Elixer Cold and Allergy Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Walgreens BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/10mL; mg/10mL N 20181231 0363-0317_ce5eef7f-497d-4c88-be6a-17eeb6e07f5b 0363-0317 HUMAN OTC DRUG Antacid Regular Strength Antacid TABLET, CHEWABLE ORAL 20171218 OTC MONOGRAPH FINAL part331 WALGREEN CO. CALCIUM CARBONATE 500 mg/1 N 20181231 0363-0318_98b3e75a-c542-471d-983a-83729d87a690 0363-0318 HUMAN OTC DRUG Rinse Eucalyptol, menthol, Methyl salicylate, thymol MOUTHWASH ORAL 19900515 OTC MONOGRAPH NOT FINAL part356 Walgreen Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0363-0319_35fee418-d4a2-4379-92f3-13df1ed95763 0363-0319 HUMAN OTC DRUG Soothe BISMUTH SUBSALICYLATE TABLET, CHEWABLE ORAL 19980716 OTC MONOGRAPH FINAL part335 Walgreen Company BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 0363-0321_2a09cd23-6145-4212-84af-60e80332388b 0363-0321 HUMAN OTC DRUG Acid Controller Complete dual action famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080730 ANDA ANDA077355 Walgreen Company FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 0363-0325_65783e06-9c7a-45d7-af90-7151e338dbdd 0363-0325 HUMAN OTC DRUG mucus relief er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160318 ANDA ANDA091009 Walgreen Company GUAIFENESIN 1200 mg/1 N 20191231 0363-0326_c8ca8e75-75fc-4fe3-b70d-d8cf20801dbf 0363-0326 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20050212 20181214 OTC MONOGRAPH NOT FINAL part334 WALGREEN CO. BISACODYL 5 mg/1 E 20171231 0363-0327_3aa1d30b-b541-4968-805d-02ba90148da1 0363-0327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Walgreen Company BISACODYL 5 mg/1 N 20181231 0363-0328_7fa8d409-97c0-498d-9ca4-97df3826cd9e 0363-0328 HUMAN OTC DRUG Magnesium Citrate saline laxative Magnesium citrate LIQUID ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 Walgreens MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 0363-0329_288b2967-0ba2-48e9-8081-664428088922 0363-0329 HUMAN OTC DRUG WAL-DRYL ALLERGY Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0363-0330_880ddf49-176b-46e0-bc50-3129035ac29f 0363-0330 HUMAN OTC DRUG infants dye free pain and fever Acetaminophen SUSPENSION ORAL 20131022 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0332_5cfefdfe-1b02-4843-b13a-e0e277b86327 0363-0332 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 19951110 OTC MONOGRAPH NOT FINAL part334 Walgreen Company MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0363-0334_e139d658-df7f-44ee-92f4-abf0c729b6f6 0363-0334 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Walgreen Company ACETAMINOPHEN 650 mg/1 N 20181231 0363-0336_4416f7c3-0b25-4ba1-863f-cc1c07506a92 0363-0336 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Walgreen Company ACETAMINOPHEN 650 mg/1 N 20181231 0363-0337_04dce1ea-0e1d-484e-8fb0-5674a12a1cfc 0363-0337 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride LIQUID ORAL 20141230 OTC MONOGRAPH FINAL part341 Walgreens DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 0363-0338_be2be50c-cbb9-4848-b8fb-447efb6b1406 0363-0338 HUMAN OTC DRUG Backache Relief Extra Strength Magnesium Salicylate Tetrahydrate TABLET ORAL 19981107 20180410 OTC MONOGRAPH NOT FINAL part343 Walgreen Company MAGNESIUM SALICYLATE 580 mg/1 E 20171231 0363-0339_dddf5a86-f485-409b-bbba-103bccb400c5 0363-0339 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20100716 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g N 20181231 0363-0340_dfe2690b-13cf-4aaa-bf84-96214052ddd8 0363-0340 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, EXTENDED RELEASE ORAL 20160501 ANDA ANDA078569 Walgreen Company ACETAMINOPHEN 650 mg/1 N 20181231 0363-0344_762c9fc0-80d9-4e69-bb1f-cd9e4e74d476 0363-0344 HUMAN OTC DRUG Anticavity Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20100722 OTC MONOGRAPH FINAL part355 Walgreen Co SODIUM FLUORIDE .1 mg/mL N 20181231 0363-0346_5de41d25-1dff-43da-aac5-4c2de74782e3 0363-0346 HUMAN OTC DRUG Soothe Bismuth Subsalicylate TABLET ORAL 20110506 OTC MONOGRAPH FINAL part335 Walgreen Company BISMUTH SUBSALICYLATE 262 mg/1 N 20191231 0363-0347_b93e6dae-1aa3-4d2b-96ec-6cbdb3fd3f68 0363-0347 HUMAN OTC DRUG Laxative Regular Strength Sennosides TABLET, COATED ORAL 20031208 OTC MONOGRAPH NOT FINAL part334 Walgreen Company SENNOSIDES 15 mg/1 N 20181231 0363-0348_733d239c-9c52-4c20-8bb1-9b1a47f15333 0363-0348 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET, SUGAR COATED ORAL 20030102 OTC MONOGRAPH NOT FINAL part334 Walgreen Company SENNOSIDES 25 mg/1 N 20181231 0363-0350_cf462529-fe36-43eb-b45b-bfde56711349 0363-0350 HUMAN OTC DRUG PAIN RELIEVER PM Extra Strength Acetaminophen, Diphenhydramine HCl CAPSULE, GELATIN COATED ORAL 20130531 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0363-0351_f2d02801-2385-484d-9a4c-d81df6b273d4 0363-0351 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 19950921 20180727 OTC MONOGRAPH NOT FINAL part334 WALGREEN CO. DOCUSATE SODIUM 100 mg/1 E 20171231 0363-0352_94d81b3b-2e78-4691-8bb0-f003fddc5395 0363-0352 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130924 ANDA ANDA201745 Walgreen Company RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 0363-0359_3fafeaf8-e818-46b8-85b9-bff6d1b88b38 0363-0359 HUMAN OTC DRUG Wal Tussin Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19951006 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 0363-0360_ce5ea0c1-6d8b-41a3-aac1-5d2f59cee9a1 0363-0360 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090402 OTC MONOGRAPH NOT FINAL part334 Walgreens MINERAL OIL 15 mL/15mL N 20181231 0363-0362_d8575572-2e3c-4acc-9250-d64bec02d361 0363-0362 HUMAN OTC DRUG Wal-Zan Ranitidine TABLET ORAL 20110628 ANDA ANDA200536 Walgreen Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 0363-0365_e75a074e-758b-47d1-a0f5-942f88c58265 0363-0365 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20130322 ANDA ANDA091349 Walgreen Company NICOTINE 2 mg/1 N 20181231 0363-0367_c969221b-74db-4482-86d7-e3af9daebd8e 0363-0367 HUMAN OTC DRUG Sleep Aid Nighttime Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0363-0368_3f8993d6-8ef3-4f24-9179-03ef59e0e234 0363-0368 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 19970114 ANDA ANDA074661 Walgreen Company NAPROXEN SODIUM 220 mg/1 N 20181231 0363-0369_40a8c1fc-ef7e-4a1b-8d41-ddd7bf95b2ad 0363-0369 HUMAN OTC DRUG Hydrocortisone maximum strength Hydrocortisone CREAM TOPICAL 20090227 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g N 20181231 0363-0370_ac18edae-c54c-4551-9948-e76dcec54420 0363-0370 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part333A Walgreen CO ALCOHOL 70 mL/100mL N 20181231 0363-0371_cb012b4f-a936-477a-858f-be448f0e526a 0363-0371 HUMAN OTC DRUG Soothe Maximum Strength Bismuth subsalicylate LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part335 Walgreens BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 0363-0372_1ec64dde-597a-4d21-b109-9cd630b4b71f 0363-0372 HUMAN OTC DRUG Mucus Relief Plus Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20020727 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0363-0373_506d6920-559e-4d34-9527-4979fc40cbd1 0363-0373 HUMAN OTC DRUG Headache Relief PM Acetaminophen, Diphenhydramine citrate TABLET, FILM COATED ORAL 20040607 20180513 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 E 20171231 0363-0374_a766f2cc-e6ff-4f68-b08d-9707e81af099 0363-0374 HUMAN OTC DRUG migraine relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20020502 ANDA ANDA075794 Walgreen Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0363-0375_559a6af4-2dba-46b1-b90a-5eeeb6ba191b 0363-0375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 Walgreen Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20191231 0363-0376_31919943-3ee0-495b-8e47-d96f2674dc2f 0363-0376 HUMAN OTC DRUG Sore throat cherry Phenol SPRAY ORAL 20140831 OTC MONOGRAPH NOT FINAL part356 Walgreens PHENOL 1.4 g/100mL N 20181231 0363-0379_db0fdb0f-403a-4b8d-8aa2-a20015432a34 0363-0379 HUMAN OTC DRUG wal dryl allergy childrens Diphenhydramine Hydrochloride SOLUTION ORAL 19890715 OTC MONOGRAPH FINAL part341 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 0363-0382_2b08c164-cf5d-4eb0-8f1d-2bdd96952b0e 0363-0382 HUMAN OTC DRUG Wal-Finate D Chlorpheniramine maleate, Pseudoephedrine TABLET ORAL 20010521 OTC MONOGRAPH FINAL part341 Walgreen Company CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 60 mg/1; mg/1 N 20181231 0363-0384_957c094d-d125-44c9-957f-5140d8a01af0 0363-0384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120828 ANDA ANDA091135 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20191231 0363-0390_ed935d12-b874-4878-87da-8129ce0f2df2 0363-0390 HUMAN OTC DRUG ephrine nose extra strength Phenylephrine hydrochloride SOLUTION/ DROPS NASAL 19951020 OTC MONOGRAPH FINAL part341 Walgreen Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20191231 0363-0391_1958fc10-e955-4415-9eb3-f653d378af25 0363-0391 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine, Pyrilamine maleate CAPSULE, LIQUID FILLED ORAL 20010614 20180916 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 E 20171231 0363-0392_c527fbd1-ffbe-4a48-b9ff-852c15ee2d0c 0363-0392 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Walgreen Company IBUPROFEN 200 mg/1 N 20181231 0363-0393_ee13e6fd-7a5a-4952-84c6-d5c8014df369 0363-0393 HUMAN OTC DRUG Ibuprofen 200 Ibuprofen TABLET, COATED ORAL 19990301 ANDA ANDA075139 Walgreen Company IBUPROFEN 200 mg/1 N 20181231 0363-0394_fab7f59f-aa4d-4a8b-9d22-cd475ccfbf20 0363-0394 HUMAN OTC DRUG phenylephrine hydrochloride phenylephrine hydrochloride SUPPOSITORY RECTAL 20051201 OTC MONOGRAPH FINAL part346 Walgreen Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2077; 6; 73 mg/1; mg/1; mg/1 E 20171231 0363-0395_5e2a7938-2f2b-47eb-870b-03ae1abad02e 0363-0395 HUMAN OTC DRUG Epsom Salt Magnesium sulfate GRANULE ORAL; TOPICAL 20160430 OTC MONOGRAPH NOT FINAL part334 Walgreens MAGNESIUM SULFATE, UNSPECIFIED 1 g/g N 20181231 0363-0396_a60c63a5-de36-49fa-9d54-04201fa2c1a7 0363-0396 HUMAN OTC DRUG wal tussin dm Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19951006 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20191231 0363-0397_e331e3ec-8aec-4d31-915c-61989c12b62a 0363-0397 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20010904 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ASPIRIN 81 mg/1 N 20181231 0363-0401_cc2a459e-4352-4677-b392-c5fe3a454bb5 0363-0401 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110808 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 0363-0402_64e1ba10-f315-47f9-ae64-1d47d6e5a241 0363-0402 HUMAN OTC DRUG Walgreen Maximum Strength Diaper Rash ZINC OXIDE OINTMENT TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 WALGREEN COMPANY ZINC OXIDE 400 mg/g N 20181231 0363-0402_798bc7cd-956d-4936-bb3e-38ce0394308a 0363-0402 HUMAN OTC DRUG Walgreen Maximum Strength Diaper Rash ZINC OXIDE OINTMENT TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 WALGREEN COMPANY ZINC OXIDE 400 mg/g N 20181231 0363-0403_8772c708-c9c0-4fc8-8fb2-17d84a4d32fb 0363-0403 HUMAN OTC DRUG Wal Dram Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 Walgreen Company MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 0363-0404_e69f3422-d986-4e9e-bcf5-19cf57f05052 0363-0404 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET, CHEWABLE ORAL 20020529 OTC MONOGRAPH FINAL part336 Walgreen Company MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 0363-0405_687751e6-58e0-43ae-9722-a000a492ddbe 0363-0405 HUMAN OTC DRUG Well at Walgreens SODIUM BICARBONATE, SODIUM CHLORIDE KIT NASAL 20130401 UNAPPROVED DRUG OTHER Walgreen Company N 20181231 0363-0407_5e3f402a-34e6-479d-9fd9-cdbacc8bb1b2 0363-0407 HUMAN OTC DRUG Walgreens Cold Sore Treatment Camphor CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Walgreens BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 0363-0407_70afbecc-f39b-48d7-9839-907a786a8c29 0363-0407 HUMAN OTC DRUG Walgreens Cold Sore Treatment Camphor CREAM TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part348 Walgreens BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 0363-0408_734c278c-1b9e-4909-bb6c-64b9af29ce14 0363-0408 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20140831 ANDA ANDA078682 Walgreens IBUPROFEN 200 mg/1 N 20181231 0363-0409_e38321ca-29a7-4b31-ac93-af3b148be7d3 0363-0409 HUMAN OTC DRUG Childrens Allergy Plus Congestion Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part341 Walgreens DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/5mL; mg/5mL N 20181231 0363-0410_aa20aade-df27-46fb-9bc0-cce9cd1cbdfb 0363-0410 HUMAN OTC DRUG Mucus Relief Severe Cold Daytime Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Walgreens DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 650; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 0363-0411_ac966062-9efd-4817-bd13-c9fb03fcdc44 0363-0411 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20060223 ANDA ANDA077007 Walgreen Company NICOTINE 2 mg/1 N 20181231 0363-0412_03fe3e16-311e-4910-aa5d-0be76a0aca1f 0363-0412 HUMAN OTC DRUG Non-Drowsy Wal-Phed PE Triple Relief Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 20191206 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 0363-0413_afa50423-9ecb-41c1-bf12-190acc30ec77 0363-0413 HUMAN OTC DRUG Ibuprofen PM Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20100209 ANDA ANDA079113 Walgreen Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 0363-0414_9c5d8aae-939c-4d6f-b730-792370876cf3 0363-0414 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20040114 20180527 OTC MONOGRAPH FINAL part343 WALGREEN CO. ASPIRIN 81 mg/1 E 20171231 0363-0417_7a4ef04e-f569-4172-91af-8a397d435b65 0363-0417 HUMAN OTC DRUG Cough and Chest Congestion DM Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Walgreens DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 0363-0418_c86b9f2b-6de9-43a7-b7cd-949f5e807e35 0363-0418 HUMAN OTC DRUG Wal-Dryl Allergy Diphenhydramine HCl LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Walgreens DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/10mL N 20181231 0363-0419_e18ebad8-a888-4400-b220-eb02cb6c5630 0363-0419 HUMAN OTC DRUG Cough Childrens Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 19930409 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 0363-0422_97adedb1-757e-4aec-b484-8789461bfb84 0363-0422 HUMAN OTC DRUG Daytime Nighttime Cold and Cough Childrens Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl, Phenylephrine HCl KIT 20140930 OTC MONOGRAPH FINAL part341 Walgreens N 20181231 0363-0423_2bb03f3f-f225-44ce-88dd-f7e377b90928 0363-0423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, COATED ORAL 20170801 ANDA ANDA074567 WALGREEN COMPANY IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 0363-0424_08c8f505-53b2-43d0-a644-9adbcc4de948 0363-0424 HUMAN OTC DRUG Nicotine Nicotine polacrilex LOZENGE ORAL 20100112 ANDA ANDA090821 Walgreen Company NICOTINE 4 mg/1 N 20181231 0363-0426_19c0cb92-10cd-47d0-bed5-d8c56fc9efc7 0363-0426 HUMAN OTC DRUG Tioconazole 1 Tioconazole OINTMENT VAGINAL 20071219 ANDA ANDA075915 Walgreen Company TIOCONAZOLE 6.5 g/100g N 20181231 0363-0428_64cca7e7-1817-4e31-a87e-7ca5125238d6 0363-0428 HUMAN OTC DRUG Tension Headache Relief Acetaminophen, Caffeine TABLET, FILM COATED ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 0363-0429_7fd7efbf-0052-451a-9095-da24a770977c 0363-0429 HUMAN OTC DRUG Nicotine Coated Mint Nicotine Polacrilex GUM, CHEWING BUCCAL 20161130 ANDA ANDA078697 Walgreen Company NICOTINE 4 mg/1 N 20181231 0363-0430_3b379c44-6c22-43b5-aa3c-2998a19adf7c 0363-0430 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20100831 NDA NDA020065 Walgreen Company NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL N 20181231 0363-0431_34343fcc-a1c3-492b-866e-aee12a2ac019 0363-0431 HUMAN OTC DRUG Extra Strength Back and Body Aspirin, Caffeine TABLET ORAL 20040412 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 N 20181231 0363-0434_9644cc95-df9e-4dc7-b218-57ac3eee7e03 0363-0434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20131010 OTC MONOGRAPH NOT FINAL part356 Walgreen Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0363-0438_5b37c4ab-685a-4b4e-8451-1137a9d41c81 0363-0438 HUMAN OTC DRUG Dye Free Ibuprofen Ibuprofen TABLET ORAL 19990301 ANDA ANDA075139 Walgreen Company IBUPROFEN 200 mg/1 N 20181231 0363-0439_a0889215-7e5f-42f4-8d44-8f361c2667a7 0363-0439 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20040414 20180505 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ASPIRIN 81 mg/1 N 20181231 0363-0440_b893621c-b6be-4f23-83c0-bbbd3f0f5988 0363-0440 HUMAN OTC DRUG Walgreens Children Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20161101 OTC MONOGRAPH NOT FINAL part334 Walgreens GLYCERIN 83 g/100g N 20181231 0363-0440_bf5e0afe-a6a5-4e9c-be8a-12cb8c5de14a 0363-0440 HUMAN OTC DRUG Walgreens Children Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20141006 OTC MONOGRAPH NOT FINAL part334 Walgreens GLYCERIN 83 g/100g N 20181231 0363-0441_83cc3222-6cd4-4c60-9ff2-f411fbfae42a 0363-0441 HUMAN OTC DRUG WAL SOM NIGHTTIME SLEEP AID Doxylamine succinate TABLET ORAL 19990305 ANDA ANDA040167 Walgreen Company DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 0363-0443_2a72af55-4bb1-4903-bf27-594a08ccc4ca 0363-0443 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0363-0444_52f2ac09-ff27-4407-bf16-a005693e7096 0363-0444 HUMAN OTC DRUG Nighttime Daytime Cough dextromethorphan HBr, doxylamine succinate KIT 20140225 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-0445_035d8236-5499-47c2-859c-5847cecc5e61 0363-0445 HUMAN OTC DRUG Walgreens Adult Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20141003 OTC MONOGRAPH NOT FINAL part334 Walgreens GLYCERIN 83 g/100g N 20181231 0363-0445_71a423c3-3f77-443f-9b88-140464c551ea 0363-0445 HUMAN OTC DRUG Walgreens Adult Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20141006 OTC MONOGRAPH NOT FINAL part334 Walgreens GLYCERIN 83 g/100g N 20181231 0363-0445_95e31783-7f23-4bc8-bf03-04ef734a1684 0363-0445 HUMAN OTC DRUG Walgreens Adult Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20161101 OTC MONOGRAPH NOT FINAL part334 Walgreens GLYCERIN 83 g/100g N 20181231 0363-0445_d77bcb41-5cf4-43ce-b78b-5e7749b5414e 0363-0445 HUMAN OTC DRUG Walgreens Adult Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20141006 OTC MONOGRAPH NOT FINAL part334 Walgreens GLYCERIN 83 g/100g N 20181231 0363-0446_53f1cc6c-4021-4256-9f2a-c50aac793b2d 0363-0446 HUMAN OTC DRUG NICOTINE nicotine polacrilex LOZENGE ORAL 20110714 NDA NDA021330 Walgreens NICOTINE 2 mg/1 N 20181231 0363-0447_f91b5bb2-95eb-484d-a00e-5dcff33b62bb 0363-0447 HUMAN OTC DRUG Childrens Pain and Fever Fast Dissolving Acetaminophen TABLET, CHEWABLE ORAL 20050203 20201128 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 80 mg/1 N 20191231 0363-0448_680fc111-bf23-42fa-d379-fc6fbf780d1d 0363-0448 HUMAN OTC DRUG Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE ORAL 20150717 ANDA ANDA076667 Walgreens Company FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 N 20181231 0363-0451_2d3a7989-b201-a2b4-558a-580efe0e09d6 0363-0451 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150901 NDA NDA020076 Walgreens Company NICOTINE 7 mg/24h N 20181231 0363-0452_c23d0484-2d25-4c99-961f-d0c517851657 0363-0452 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen TABLET, CHEWABLE ORAL 20041206 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 80 mg/1 N 20181231 0363-0453_7ab4df1a-e00c-494a-beae-cf7fe911185c 0363-0453 HUMAN OTC DRUG Wal-Phed PE Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 Walgreen Company PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 0363-0455_2d3a7989-b201-a2b4-558a-580efe0e09d6 0363-0455 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150901 NDA NDA020076 Walgreens Company NICOTINE 21 mg/24h N 20181231 0363-0456_45aa495f-dd22-4e88-aeff-b90b45e53efb 0363-0456 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061027 ANDA ANDA076777 Walgreen Company NICOTINE 2 mg/1 N 20191231 0363-0457_2d3a7989-b201-a2b4-558a-580efe0e09d6 0363-0457 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150901 NDA NDA020076 Walgreens Company NICOTINE 14 mg/24h N 20181231 0363-0460_40cc056c-0638-42bb-8c9a-bd66a2a73474 0363-0460 HUMAN OTC DRUG Nighttime Cold and Flu Maximum Strength Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 0363-0461_83e69173-5cc3-4479-bc5f-37dea27e9f09 0363-0461 HUMAN OTC DRUG Flu HBP Acetaminophen, Dextromethorphan HBr, Chlorpheniramine maleate TABLET, FILM COATED ORAL 20050601 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE 500; 15; 2 mg/1; mg/1; mg/1 N 20181231 0363-0462_e6ab47b3-e6bb-4231-9b79-10cd348d477a 0363-0462 HUMAN OTC DRUG Wal-Phed PE Maximum Strength Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341 Walgreen Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 0363-0463_470e3c1d-d305-4617-ad05-f30e1409f029 0363-0463 HUMAN OTC DRUG DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum Strength Daytime Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI, NightTime Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI KIT 20160331 OTC MONOGRAPH FINAL part341 Walgreens N 20181231 0363-0466_827c8fb1-acc0-4c11-ba82-0e2f32d2dbcb 0363-0466 HUMAN OTC DRUG Walgreens Gentle Laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 Walgreens BISACODYL 10 mg/2000mg N 20181231 0363-0466_c9ae7cd3-5eea-4d9a-a77a-5e49f9bdd7f3 0363-0466 HUMAN OTC DRUG Walgreens Gentle Laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 Walgreens BISACODYL 10 mg/2000mg N 20181231 0363-0469_cb9f9be8-4ffa-4d7d-ad13-fdc06f80a52e 0363-0469 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20150126 OTC MONOGRAPH NOT FINAL part333A Walgreens ALCOHOL 545 mg/mL N 20181231 0363-0470_fd05f9ff-49f7-49cc-b076-914d26810658 0363-0470 HUMAN OTC DRUG Cold Multi-Symptom Daytime Non-Drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 20180922 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 0363-0472_35fa4580-d973-4da4-861a-10ab340e742f 0363-0472 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20170630 OTC MONOGRAPH NOT FINAL part333A Walgreens ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 0363-0474_b98322fa-2b8b-45cf-a395-4949f6ca97c1 0363-0474 HUMAN OTC DRUG Mucus Relief DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 WALGREEN CO. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 600; 30 mg/1; mg/1 N 20181231 0363-0475_aae8e70d-094a-482c-ba64-200c8133e0eb 0363-0475 HUMAN OTC DRUG childrens wal zyr Cetirizine HCl SOLUTION ORAL 20150922 ANDA ANDA204226 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0363-0478_4bb3e154-2b9e-4e1e-b3c5-fef971f3c74e 0363-0478 HUMAN OTC DRUG Sinus Relief Severe Congestion Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 0363-0480_23f21e78-9036-44fd-b771-8b2bf55b760e 0363-0480 HUMAN OTC DRUG Oil-Free Daily Face Salicylic Acid CREAM TOPICAL 20140915 OTC MONOGRAPH FINAL part333D Walgreen Company SALICYLIC ACID 2 g/100g N 20181231 0363-0482_872aa009-ac8e-4b96-a1a1-457ef61647b3 0363-0482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20130601 OTC MONOGRAPH FINAL part355 Walgreen Co SODIUM FLUORIDE .1 mg/mL N 20181231 0363-0486_56445f13-d561-4c5b-b94d-4776386248fa 0363-0486 HUMAN OTC DRUG Senna laxative Sennosides TABLET ORAL 20151031 OTC MONOGRAPH NOT FINAL part334 Walgreens SENNOSIDES 8.6 mg/1 N 20181231 0363-0487_df51868f-e8f3-470a-91e8-6bf38f714e99 0363-0487 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part347 Walgreens DIMETHICONE 125 mg/1 N 20181231 0363-0490_20c36d4a-42b2-4235-a438-659e0bf6a9c7 0363-0490 HUMAN OTC DRUG Pain Relief All Day Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Walgreen Company NAPROXEN SODIUM 220 mg/1 N 20181231 0363-0491_0a35db46-e97e-456d-929d-a6c6733ca884 0363-0491 HUMAN OTC DRUG Wal-Finate Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Walgreen Company CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 0363-0494_675bc4e7-b4b6-4117-becb-29ebeecf0013 0363-0494 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150701 ANDA ANDA091135 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20191231 0363-0495_ff11c79d-6b6f-457d-b4bc-fe9f2e9bdb4f 0363-0495 HUMAN OTC DRUG Wal Zyr Cetirizine Hydrochloride TABLET ORAL 20080109 ANDA ANDA078336 Walgreen Company CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0363-0498_c8c5c6b5-9b73-49ac-8533-26a13945251c 0363-0498 HUMAN OTC DRUG Mucus Relief ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130318 ANDA ANDA078912 Walgreen Company GUAIFENESIN 600 mg/1 N 20181231 0363-0500_7460410b-aff3-4aae-9724-438d1dd13b2b 0363-0500 HUMAN OTC DRUG Cough Dextromethorphan HBr SOLUTION ORAL 20140220 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL N 20181231 0363-0502_e1a40b9d-a5ba-47da-bb66-57f8c21cd977 0363-0502 HUMAN OTC DRUG Wal-Phed PE Maximum Strength, Non-Drowsy Acetaminophen, Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 0363-0503_c11269d6-97cb-46b8-9da2-6f2a4cb4ad10 0363-0503 HUMAN OTC DRUG Severe Cold Daytime Multi-Symptom Non-Drowsy Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0363-0504_66f343ed-4fe1-4c03-8d34-84f8df1adbb8 0363-0504 HUMAN OTC DRUG Well at Walgreens SODIUM BICARBONATE, SODIUM CHLORIDE KIT NASAL 20130401 UNAPPROVED DRUG OTHER Walgreen Company N 20181231 0363-0505_73a4230e-d3e5-41fe-84f9-ca748f74ff64 0363-0505 HUMAN OTC DRUG Mucus Relief DM Maximum Strength dextromethorphan hydrobromide, guaifenesin LIQUID ORAL 20170831 OTC MONOGRAPH FINAL part341 Walgreens DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 0363-0506_f3ffa346-8fb9-45d5-8857-fa091c880999 0363-0506 HUMAN OTC DRUG Cough and Chest Congestion DM Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20160229 OTC MONOGRAPH FINAL part341 Walgreens DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 0363-0507_aa18b3fe-88bd-4391-a298-098ac300e726 0363-0507 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20131209 ANDA ANDA076359 Walgreen Company IBUPROFEN 100 mg/1 N 20181231 0363-0508_5ec29647-b107-4a69-81c9-af451bd853b7 0363-0508 HUMAN OTC DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20171016 ANDA ANDA209339 WALGREEN CO. ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg/1 N 20191231 0363-0510_4a30861f-e995-4239-8ca3-08ebc5c3fd6c 0363-0510 HUMAN OTC DRUG Maximum Strength Mucus Relief DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 WALGREEN CO. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 0363-0511_3a456dab-0a2d-4e48-a8e2-e49a7acef963 0363-0511 HUMAN OTC DRUG Acid Reducer Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160129 ANDA ANDA077355 Walgreen Company FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 0363-0512_755b22cf-50d5-4985-b77f-15c274a9412f 0363-0512 HUMAN OTC DRUG Mucus Congestion and Cough Relief Childrens Dextromethorphan HBr, Guaifensin, Phenylephrine HCI LIQUID ORAL 20160430 OTC MONOGRAPH FINAL part341 Walgreens DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 0363-0516_42281a62-7785-4a96-a34a-dc9c826722ff 0363-0516 HUMAN OTC DRUG Wal Tussin Adult Cough and Cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060714 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 0363-0518_b4c5cb1e-f410-4c92-b9cb-e76efe28f66b 0363-0518 HUMAN OTC DRUG Severe Allergy Acetaminophen and Diphenhydramine HCl TABLET ORAL 20050606 20180610 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 12.5 mg/1; mg/1 E 20171231 0363-0519_29df250e-178e-4441-8a7b-7be8d9a8d806 0363-0519 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 500 mg/1 N 20181231 0363-0520_048a452e-d902-4f36-b68c-281f621abb1f 0363-0520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20120530 NDA NDA021855 Walgreens LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 0363-0521_bebdc250-07eb-46c5-8de9-4f7ed5e227a4 0363-0521 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20090505 ANDA ANDA076359 Walgreen Company IBUPROFEN 100 mg/1 N 20181231 0363-0522_5abc21be-ea9c-491b-a077-d5a6809f0a4c 0363-0522 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20131205 ANDA ANDA076134 Walgreen Company LORATADINE 10 mg/1 N 20181231 0363-0523_1d16016e-8080-4df1-99f1-5a0a6884d96a 0363-0523 HUMAN OTC DRUG Ibuprofen Junior Strength Ibuprofen TABLET, CHEWABLE ORAL 20121218 ANDA ANDA076359 Walgreen Company IBUPROFEN 100 mg/1 N 20181231 0363-0524_8c4d172b-e8dc-47da-8c6e-71d2df284067 0363-0524 HUMAN OTC DRUG Sinus Relief Maximum Strength Acetaminophen, Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20170430 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0363-0525_e525f6fc-6b1d-4799-a7c2-c6270b6d5fd8 0363-0525 HUMAN OTC DRUG Wal-dryl Itch Relief diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20060118 OTC MONOGRAPH NOT FINAL part348 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g E 20171231 0363-0526_ce3f43d8-7894-4f12-b032-514178875d70 0363-0526 HUMAN OTC DRUG Wal-Phed PE, Multi-Symptom Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED ORAL 20050621 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 0363-0527_02b3be0a-9cf0-432e-a486-202d011be12b 0363-0527 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Walgreen Company LORATADINE 10 mg/1 N 20181231 0363-0529_8fa90244-a908-4867-a0a8-893b9ca9fa13 0363-0529 HUMAN OTC DRUG Cold MULTI-SYMPTOM, DAYTIME / NIGHTTIME Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-0529_a223b3ce-e2c2-4142-8a69-1bf6e44952e9 0363-0529 HUMAN OTC DRUG Cold MULTI-SYMPTOM, DAYTIME / NIGHTTIME Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-0530_a81effb1-2dad-4667-a0aa-ee6149240e84 0363-0530 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20140331 OTC MONOGRAPH FINAL part332 Walgreens DIMETHICONE 180 mg/1 N 20181231 0363-0531_185ed81a-7ae1-430a-9767-a93edb0d8523 0363-0531 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET, COATED ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 500 mg/1 N 20181231 0363-0532_098e114d-c3f6-41d5-84e1-ba7a9c134783 0363-0532 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, FILM COATED ORAL 20051222 OTC MONOGRAPH FINAL part341 Walgreen Company GUAIFENESIN 400 mg/1 N 20181231 0363-0533_2b989334-7e5c-41b8-a5ee-d4c6ace6a313 0363-0533 HUMAN OTC DRUG Mucus Relief DM Guaifenesin and Dextromethorphan HBr TABLET, FILM COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 Walgreen Company GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 0363-0534_b66e968b-c2ee-484f-9520-93cc4e6eeb4e 0363-0534 HUMAN OTC DRUG Daytime Multi-Symptom Non-Drowsy Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070919 20180727 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 0363-0535_7a2cd823-1ab6-413b-90ed-5ec22bbf625b 0363-0535 HUMAN OTC DRUG Nighttime Multi-Symptom Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20070910 20180727 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 E 20171231 0363-0536_6a5339d8-93f2-4f6c-879d-f93d62d1a79f 0363-0536 HUMAN OTC DRUG Walgreens Oil-Free Acne Wash Salicylic Acid SOLUTION TOPICAL 20130105 OTC MONOGRAPH FINAL part333D Walgreens Company SALICYLIC ACID 2 g/100mL N 20181231 0363-0539_365d6756-210d-4d93-b30b-4d4b27bb0927 0363-0539 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20150507 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 0363-0540_8fb13b3f-184b-4491-adfa-a8d924801682 0363-0540 HUMAN OTC DRUG Hydrating Antioxidant Moiturizer AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20171028 OTC MONOGRAPH NOT FINAL part352 Walgreen Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.478; 4.72; 4.72; 2.36 g/118mL; g/118mL; g/118mL; 1/118mL N 20181231 0363-0542_bd63ee2e-b676-4b62-a48d-fde5d54de08d 0363-0542 HUMAN OTC DRUG Mucus Relief PE Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20060415 OTC MONOGRAPH FINAL part341 Walgreen Company GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 0363-0543_5e913eaf-180b-4a48-8ca9-950651e91735 0363-0543 HUMAN OTC DRUG Wal-Dryl Maximum Strength Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET ORAL 20070627 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 0363-0544_c5cfd52e-948b-4030-a9a4-a6f43f0ea9bb 0363-0544 HUMAN OTC DRUG arthritis pain reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000526 ANDA ANDA075077 Walgreen Company ACETAMINOPHEN 650 mg/1 N 20181231 0363-0545_1ce88738-3c19-4960-a7f6-44652f7eeb44 0363-0545 HUMAN OTC DRUG Wal Zyr Childrens Cetirizine HCl SOLUTION ORAL 20150811 ANDA ANDA204226 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0363-0546_144ffa07-ba9c-4992-a79b-885e95b320c3 0363-0546 HUMAN OTC DRUG Acid Controller Complete dual action Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080730 ANDA ANDA077355 Walgreen Company FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 0363-0547_d0bb18ec-400a-4c12-8951-68ba1c75bc68 0363-0547 HUMAN OTC DRUG Mucus Relief D Guaifenesin, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20070126 OTC MONOGRAPH FINAL part341 Walgreen Company GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 400; 40 mg/1; mg/1 N 20181231 0363-0548_d34fd132-53d8-4737-b6aa-5455ad0da830 0363-0548 HUMAN OTC DRUG Wal-Phed PE Non-Drying Sinus Guaifenesin, Phenylephrine HCl TABLET ORAL 20030917 20180922 OTC MONOGRAPH FINAL part341 WALGREEN CO. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 200; 5 mg/1; mg/1 E 20171231 0363-0551_1c9084b2-84b3-436b-ab20-b893129c245d 0363-0551 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20030731 OTC MONOGRAPH NOT FINAL part348 Walgreen Co. MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g N 20181231 0363-0552_4807fb60-8d08-6e61-e054-00144ff8d46c 0363-0552 HUMAN OTC DRUG Studio 35 External Analgesic Medicated Body Menthol and Zinc Oxide POWDER TOPICAL 20170207 OTC MONOGRAPH NOT FINAL part348 Walgreen Co MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g N 20181231 0363-0554_e6499ca5-0cdf-4701-8943-a10e738a568d 0363-0554 HUMAN OTC DRUG Nice fresh scent Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Walgreen Co. BENZALKONIUM CHLORIDE .115 g/1 N 20181231 0363-0555_99eb5e5b-4aa9-4fdb-b7bd-53b0b0765e4c 0363-0555 HUMAN OTC DRUG Sinus Relief Daytime Nighttime Acetaminophen, Doxylamine Succinate, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 WALGREEN CO. N 20181231 0363-0556_3d6a296f-bd06-4ff2-8562-ce09affb67de 0363-0556 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0363-0557_46dc8fa6-e0ce-4187-b57f-14f454b25cd3 0363-0557 HUMAN OTC DRUG Athletes Foot Miconazole Nitrate SPRAY TOPICAL 20050609 OTC MONOGRAPH FINAL part333C Walgreen Company MICONAZOLE NITRATE 2 g/100g N 20191231 0363-0558_adab8da3-fc7d-4e2f-8e88-1fdd4b0d823b 0363-0558 HUMAN OTC DRUG Sinus Congestion and Pain Daytime, Non-drowsy Acetaminophen and Phenylephrine HCl TABLET ORAL 20080317 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 0363-0559_28ec8fed-ab69-4e70-86a5-8d144cff8f4e 0363-0559 HUMAN OTC DRUG Multi-Symptom Allergy Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20080327 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 0363-0560_58298020-612a-4286-9d74-e73eea609945 0363-0560 HUMAN OTC DRUG Cold DayTime, Multi-Symptom, Non-drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20080329 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0363-0563_c7770462-6725-44d6-bb38-b7ce0700db3c 0363-0563 HUMAN OTC DRUG Aspirin enteric coated low dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ASPIRIN 81 mg/1 N 20181231 0363-0564_fdc351cd-4d1d-43df-bb10-6fe15378dece 0363-0564 HUMAN OTC DRUG Vapor Inhaler Levmetamfetamine Nasal Decongestant INHALANT NASAL 20160701 OTC MONOGRAPH FINAL part341 Walgreens LEVMETAMFETAMINE 50 mg/1 E 20171231 0363-0566_c4dbbb9f-6198-4d32-95bb-3b6ca51ea5b0 0363-0566 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110816 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 0363-0567_58c41c6a-7c13-4fb6-a104-c7c6021bb9d5 0363-0567 HUMAN OTC DRUG daytime nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120906 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-0571_5813217f-cfb5-46c3-bc32-25a8b7ad0fc5 0363-0571 HUMAN OTC DRUG wal fex allergy fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Walgreen Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 0363-0572_2516cba1-416d-49af-8f7d-0d24f94ec12c 0363-0572 HUMAN OTC DRUG Tension Headache Relief Acetaminophen, Caffeine TABLET ORAL 20090209 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 0363-0573_3825d663-dd66-426d-8850-01d23e80f789 0363-0573 HUMAN OTC DRUG Cold and Flu Daytime Severe, Nighttime Severe Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl KIT 20050804 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-0577_efee1ab3-3c23-4af0-bf7a-7f35ab5f70dd 0363-0577 HUMAN OTC DRUG daytime nighttime severe cold and flu Acetaminophen, dextromethorphan HBr, Doxylamine Succinate, Guaifenesin, Phenylephrine HCl KIT 20150723 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-0578_be937271-5a40-4ad3-8bb7-8a371d265144 0363-0578 HUMAN OTC DRUG wal tussin dm adult cough and chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19940729 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 0363-0579_f2085b26-5778-4656-8de3-9edd83f914dd 0363-0579 HUMAN OTC DRUG pain reliever fever reducer childrens Acetaminophen SUPPOSITORY RECTAL 20100219 ANDA ANDA070607 Walgreen Company ACETAMINOPHEN 120 mg/1 N 20181231 0363-0581_8f3759f8-80be-468a-84b8-d95ca6f96b54 0363-0581 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20170303 OTC MONOGRAPH FINAL part355 Walgreens SODIUM FLUORIDE .2 mg/mL N 20181231 0363-0582_0cf84ac6-6261-4049-a999-1462ce1ded2b 0363-0582 HUMAN OTC DRUG Vitamin A and D skin protectant Lanolin, Petrolatum OINTMENT TOPICAL 20090819 OTC MONOGRAPH FINAL part347 Walgreen Company LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g N 20181231 0363-0583_89d11e85-8a97-46c1-ab02-dd4a9e3527a6 0363-0583 HUMAN OTC DRUG Wal-Dryl Allergy Plus Cold Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl CAPSULE ORAL 20090710 20180916 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 E 20171231 0363-0584_54b7dc74-ede2-44b6-b040-61daf6ef860b 0363-0584 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20151130 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 0363-0585_eac81253-f418-47bd-b432-dddf3e1d4eb0 0363-0585 HUMAN OTC DRUG Childrens Wal-Dryl Allergy Diphenhydramine HCl TABLET, CHEWABLE ORAL 20090320 OTC MONOGRAPH FINAL part341 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20181231 0363-0587_8da0cff3-7197-43ed-96ca-2dde7f1ea902 0363-0587 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20090318 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ASPIRIN 81 mg/1 N 20181231 0363-0589_0b19ff6a-d15b-490e-ac5f-e279c74e970c 0363-0589 HUMAN OTC DRUG First Aid Antiseptic Wipes Benzalkonium Chloride (0.13%) CLOTH TOPICAL 20170208 OTC MONOGRAPH NOT FINAL part333A Walgreen CO BENZALKONIUM CHLORIDE .0013 mg/100mg N 20181231 0363-0590_1cd468d7-4db1-4f38-a484-3c86b11af5e8 0363-0590 HUMAN OTC DRUG pain and fever acetaminophen SUSPENSION ORAL 19930430 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0591_224fd199-8eaf-4ec4-873c-9d2e9a733c71 0363-0591 HUMAN OTC DRUG Multi-Symptom Nighttime Cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, GELATIN COATED ORAL 20080329 20181104 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 0363-0595_bc82fd85-8e23-4bad-896b-3a13f0e814ff 0363-0595 HUMAN OTC DRUG Childrens Wal Zyr 24 Hour Allergy cetirizine Hydrochloride SOLUTION ORAL 20101015 ANDA ANDA090254 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0363-0596_fa795f65-0c45-4af5-8187-399200d2ed3e 0363-0596 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20150126 OTC MONOGRAPH NOT FINAL part333A Walgreen Co ALCOHOL 567 mg/mL N 20181231 0363-0599_2ba47384-5caf-4e7e-90fb-24cb5039cd99 0363-0599 HUMAN OTC DRUG Childrens Wal-Dryl Allergy Diphenhydramine HCl TABLET, CHEWABLE ORAL 20110425 OTC MONOGRAPH FINAL part341 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20181231 0363-0600_40648b19-6a35-4481-86ac-6710284df2b0 0363-0600 HUMAN OTC DRUG Wal Fex 24 Hour Allergy fexofenadine hcl TABLET, FILM COATED ORAL 20140306 ANDA ANDA076447 Walgreen Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 0363-0601_2f476469-bf57-0fe1-e054-00144ff8d46c 0363-0601 HUMAN OTC DRUG Walgreens Wal-Flu Cold and Sore Throat Lemon Flavor Acetaminophen, Pheniramine Maleate, Phenylephrine HCl GRANULE, FOR SOLUTION ORAL 20131007 OTC MONOGRAPH FINAL part341 Walgreen Co. ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 20; 10 mg/1; mg/1; mg/1 N 20181231 0363-0602_2665a8b7-5f72-401c-e054-00144ff8d46c 0363-0602 HUMAN OTC DRUG Walgreens Sugar Free Nighttime Wal-Flu severe cold and cough Natural honey lemon flavor Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20140915 OTC MONOGRAPH FINAL part341 Walgreen Co. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 0363-0603_9c0532fb-23c6-4214-97af-e20eb1a81039 0363-0603 HUMAN OTC DRUG Severe Cold and Flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20131121 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 0363-0608_8d62b47e-44ab-4a90-96d8-01bd53f9ab48 0363-0608 HUMAN OTC DRUG Extra Strength Gas Relief Simethicone TABLET ORAL 20130701 OTC MONOGRAPH FINAL part332 Walgreen Company DIMETHICONE 125 mg/1 N 20181231 0363-0610_d186b442-7413-4447-b3f1-c3c82fb4e258 0363-0610 HUMAN OTC DRUG EYE ITCH RELIEF Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20120501 ANDA ANDA077958 Walgreens KETOTIFEN FUMARATE .25 mg/mL N 20181231 0363-0611_530923de-5115-4de0-92ed-465e2e650d6a 0363-0611 HUMAN OTC DRUG Ibuprofen PM Diphenhydramine hydrochloride, ibuprofen CAPSULE, LIQUID FILLED ORAL 20130708 ANDA ANDA200888 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 N 20181231 0363-0613_5b8fafaf-eb42-41f2-840b-f6b38ca7683c 0363-0613 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING BUCCAL 20160301 ANDA ANDA204833 Walgreen Company NICOTINE 4 mg/1 N 20181231 0363-0616_10c46170-7009-4952-abcb-0ab451e20bf2 0363-0616 HUMAN OTC DRUG Mucus Relief Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0363-0617_5bd505a2-a766-4021-a2fe-dbae4c1505af 0363-0617 HUMAN OTC DRUG Wal itin D 12 hour allergy and congestion Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120118 ANDA ANDA076050 Walgreen Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 0363-0618_3607bc83-a5be-4302-85e4-4c91bad49d56 0363-0618 HUMAN OTC DRUG Walgreens Pinworm Medicine PYRANTEL PAMOATE SUSPENSION ORAL 20151116 OTC MONOGRAPH FINAL part357B Walgreens PYRANTEL PAMOATE 144 mg/mL N 20181231 0363-0619_2f4eec57-129b-4ba2-8532-d0d541fb6994 0363-0619 HUMAN OTC DRUG Daily Moisturizing Daily Moistruizing LOTION TOPICAL 20130206 OTC MONOGRAPH FINAL part347 Walgreen, Co. DIMETHICONE 13 mg/g N 20181231 0363-0620_14c5125a-dcc1-415d-9a05-43a9542e267e 0363-0620 HUMAN OTC DRUG Maximum Strength Hydrocortisone Cream with Aloe Hydrocortisone Cream CREAM TOPICAL 20160607 OTC MONOGRAPH NOT FINAL part348 Walgreens HYDROCORTISONE 1.02 g/100g N 20181231 0363-0620_421cc292-0cc2-4e94-9b38-59c495dcb079 0363-0620 HUMAN OTC DRUG Maximum Strength Hydrocortisone Cream with Aloe Hydrocortisone Cream CREAM TOPICAL 20160607 OTC MONOGRAPH NOT FINAL part348 Walgreens HYDROCORTISONE 1.02 g/100g N 20181231 0363-0623_26e3f13b-53e5-47b9-ac5b-90c5137c6544 0363-0623 HUMAN OTC DRUG severe cold and flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20150723 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 0363-0625_7b834717-791c-4d44-a509-0142f32a18a2 0363-0625 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20160630 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0363-0627_d2bd6376-a2c3-4131-a978-58af40ab61cc 0363-0627 HUMAN OTC DRUG Sleep Aid Dye-Free NIghttime Diphenhydramine HCl TABLET, FILM COATED ORAL 20130701 OTC MONOGRAPH FINAL part338 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0363-0628_97967fe8-77a4-4ea7-b1d4-8ba727669a19 0363-0628 HUMAN OTC DRUG Mucus Relief MAXIMUM STRENGTH Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130503 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 0363-0629_5793b77d-1bf4-4b79-9a60-9c8971ec28fa 0363-0629 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150531 OTC MONOGRAPH NOT FINAL part334 Walgreens MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 0363-0630_72f422b9-5c1e-47e7-b402-2e09bb29b0ff 0363-0630 HUMAN OTC DRUG Walgreens Anticavity and Antigingivitis Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Walgreen SODIUM FLUORIDE 2.43 mg/g E 20171231 0363-0631_15482811-438f-44dd-97a3-a3d4eb07a609 0363-0631 HUMAN OTC DRUG Walgreens Maximum Strength Sensitive Fluoride Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20060606 OTC MONOGRAPH NOT FINAL part356 Walgreens POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g E 20171231 0363-0632_2e588a85-4705-5734-e054-00144ff8d46c 0363-0632 HUMAN OTC DRUG Walgreen Sensitive Extra Whitening Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20061206 OTC MONOGRAPH NOT FINAL part356 Walgreen POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g E 20171231 0363-0633_28140cfe-89d2-497f-a7c4-778557cf3de0 0363-0633 HUMAN OTC DRUG Walgreens Anticavity and Antigingivitis Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110419 OTC MONOGRAPH FINAL part355 Walgreen SODIUM FLUORIDE 2.43 mg/g E 20171231 0363-0634_e1d1b140-504b-4ddd-b34a-a825872db017 0363-0634 HUMAN OTC DRUG Walgreen Anticavity Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20090211 OTC MONOGRAPH FINAL part355 Walgreen SODIUM FLUORIDE 2.43 mg/g E 20171231 0363-0635_61a83790-36c9-4a05-a700-3dd23360cca2 0363-0635 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone TABLET, CHEWABLE ORAL 20131001 OTC MONOGRAPH FINAL part332 Walgreen Company DIMETHICONE 125 mg/1 N 20191231 0363-0637_83d2c6b1-76f3-48cc-8a42-6dc5dbd4f82d 0363-0637 HUMAN OTC DRUG Miconazole 3 Miconazole nitrate KIT 20040719 ANDA ANDA076357 Walgreen Company N 20181231 0363-0638_73c87aec-514f-431d-8865-a45e4cb0a77e 0363-0638 HUMAN OTC DRUG Maximum Strength Hydrocortisone Cream Hydrocortisone Cream CREAM TOPICAL 20160607 OTC MONOGRAPH NOT FINAL part348 Walgreens HYDROCORTISONE 1.02 g/100g N 20181231 0363-0638_c07d7283-6fdd-4ad6-92b1-53b77105f02d 0363-0638 HUMAN OTC DRUG Maximum Strength Hydrocortisone Cream Hydrocortisone Cream CREAM TOPICAL 20160607 OTC MONOGRAPH NOT FINAL part348 Walgreens HYDROCORTISONE 1.02 g/100g N 20181231 0363-0639_64e1badf-9cd0-434a-b340-ca1f5de432bd 0363-0639 HUMAN OTC DRUG Regular Strength Hydrocortisone Cream Hydrocortisone Cream CREAM TOPICAL 20160607 OTC MONOGRAPH NOT FINAL part348 Walgreens HYDROCORTISONE .51 g/100g N 20181231 0363-0640_e8823dc1-7c3d-4bdf-b2bb-4f6484acd6bb 0363-0640 HUMAN OTC DRUG Cold and Flu Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140227 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0363-0643_9c56fbdb-e653-4e86-b99c-ea0e77313837 0363-0643 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160310 OTC MONOGRAPH NOT FINAL part333A Walgreen Co ALCOHOL 558 mg/mL N 20181231 0363-0644_126a859a-b4c3-4f79-adb4-8c594184a959 0363-0644 HUMAN OTC DRUG Hand wipes Benzalkonium chloride CLOTH TOPICAL 20090105 OTC MONOGRAPH NOT FINAL part333A Walgreen Co BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 0363-0645_8aac3f97-448c-4bb9-a62e-0690071a48de 0363-0645 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120518 ANDA ANDA091292 Walgreen Company LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 0363-0647_5faf2ed0-dd72-17c9-e053-2a91aa0ab75a 0363-0647 HUMAN OTC DRUG MILK OF MAGNESIA magnesium hydroxide SUSPENSION ORAL 20141201 OTC MONOGRAPH NOT FINAL part334 WALGREEN COMPANY MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0363-0648_c0cdc5c6-90ae-44ed-8747-3104b27be34e 0363-0648 HUMAN OTC DRUG Wal Four Phenylephrine hydrochloride SPRAY NASAL 20020920 OTC MONOGRAPH FINAL part341 Walgreen Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 0363-0649_5f9cd233-6c47-5b52-e053-2991aa0ab729 0363-0649 HUMAN OTC DRUG MILK OF MAGNESIA magnesium hydroxide SUSPENSION ORAL 20170701 OTC MONOGRAPH NOT FINAL part334 WALGREEN COMPANY MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0363-0650_d3f8a26f-cb51-4dd4-96c0-82979c97b398 0363-0650 HUMAN OTC DRUG All Day Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130523 ANDA ANDA076518 Walgreen Company NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 0363-0654_7c765b71-6e52-4007-9586-76605bd463e1 0363-0654 HUMAN OTC DRUG Wal-Sleep Z Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH FINAL part338 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0363-0656_47c47468-5358-451e-aaa0-0a1b0e547528 0363-0656 HUMAN OTC DRUG Daytime Cold and Flu Relief Non Drowsy acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060707 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 0363-0660_6387ca26-ef83-4710-bec8-5dee82b3fc9d 0363-0660 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20020325 ANDA ANDA074937 Walgreen Company IBUPROFEN 100 mg/5mL N 20181231 0363-0663_df4795e7-a9ba-4256-ae5d-4567c6dee054 0363-0663 HUMAN OTC DRUG Crisp Apple Hand Sani Ethyl Alcohol LIQUID TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part333A Walgreen CO ALCOHOL 585 g/mL N 20181231 0363-0664_20d37da2-af66-4ca8-ad2c-f474b0a1020c 0363-0664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19930324 OTC MONOGRAPH NOT FINAL part356 Walgreens Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0363-0665_cd643ff8-a474-46ba-8ac8-20a8a484bb43 0363-0665 HUMAN OTC DRUG Ibuprofen and Diphenhydramine HCl IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED ORAL 20151231 ANDA ANDA090397 Walgreens IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE 200; 25 mg/1; mg/1 N 20181231 0363-0666_c97242d3-4aa6-429b-95ec-0e2ffcbf443e 0363-0666 HUMAN OTC DRUG Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20140207 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 0363-0667_b1787357-8287-4729-bc6d-f07081b32c39 0363-0667 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 19890715 OTC MONOGRAPH NOT FINAL part334 Walgreen Co MAGNESIUM CITRATE 1.745 g/29.6mL N 20191231 0363-0672_c9dd31a4-8559-405e-bf84-8adc3c823b48 0363-0672 HUMAN OTC DRUG Wal-Sleep Z Diphenhydramine HCl TABLET, FILM COATED ORAL 20150724 OTC MONOGRAPH FINAL part338 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0363-0673_99583d49-f767-4d85-b8c4-5edf2f159625 0363-0673 HUMAN OTC DRUG Anti Itch Benzocaine, Resorcinol CREAM TOPICAL 20060302 OTC MONOGRAPH NOT FINAL part348 Walgreen Company BENZOCAINE; RESORCINOL 5; 2 g/100g; g/100g N 20181231 0363-0674_38a03cf3-6887-0c36-e054-00144ff8d46c 0363-0674 HUMAN OTC DRUG Well at Walgreens Anti-Itch Maximum Strength Benzocaine and Resorcinol CREAM TOPICAL 20160727 OTC MONOGRAPH FINAL part346 Walgreens BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g N 20181231 0363-0676_163cfd88-bd47-4288-941e-d0232d46d6bf 0363-0676 HUMAN OTC DRUG Womens laxative Bisacodyl TABLET, COATED ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 Walgreen Company BISACODYL 5 mg/1 N 20181231 0363-0679_13ef0cba-39f0-42f8-a7f3-c46126d0169b 0363-0679 HUMAN OTC DRUG Stool Softener Laxative DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170831 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE SODIUM 100 mg/1 N 20181231 0363-0681_96006f78-371a-47bc-ab30-eb6f6bc67da6 0363-0681 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride LIQUID ORAL 20170531 OTC MONOGRAPH FINAL part341 Walgreens DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 0363-0682_dfa21669-abc4-43ad-aae0-a644c19e3996 0363-0682 HUMAN OTC DRUG Wal Som Nighttime Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20160731 OTC MONOGRAPH FINAL part338 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0363-0685_319651f0-d86b-46e5-963c-c1c4f8551e07 0363-0685 HUMAN OTC DRUG Ibuprofen Ibuprofen LIQUID ORAL 20080724 ANDA ANDA074937 Walgreen Company IBUPROFEN 100 mg/5mL N 20181231 0363-0687_c7084d06-05cf-41cd-95e8-d6bec9f34951 0363-0687 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl TABLET, FILM COATED ORAL 20160731 OTC MONOGRAPH FINAL part338 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 0363-0691_8ad09903-c36a-4fb8-a191-ed422cbde435 0363-0691 HUMAN OTC DRUG Aspirin 325 Aspirin TABLET, COATED ORAL 20170701 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ASPIRIN 325 mg/1 N 20181231 0363-0692_a8763a67-cd36-45ac-a02c-2966d6c6b3c1 0363-0692 HUMAN OTC DRUG Walgreens 7-in-1 Anti-Aging Vitamin Complex Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130105 OTC MONOGRAPH NOT FINAL part352 Walgreen Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mg/100mL; mg/100mL; mg/100mL N 20181231 0363-0693_e5dffc4e-83b5-4c60-916f-6008a1974e06 0363-0693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20000714 OTC MONOGRAPH NOT FINAL part334 Walgreens Co MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 0363-0695_b7e2f322-409c-4ea7-9704-8c7aa638de81 0363-0695 HUMAN OTC DRUG jock itch Tolnaftate SPRAY TOPICAL 20050608 OTC MONOGRAPH FINAL part333C Walgreen Company TOLNAFTATE 1 g/100g N 20181231 0363-0696_e0cb3430-1364-4a06-8d14-12559d314c0c 0363-0696 HUMAN OTC DRUG Walgreens Anti-Sagging and Ultra Hydrating Day Cream Broad Spectrum SPF15 Sunscreen Avobenzone, Benzophenone-3, Octinoxate CREAM TOPICAL 20130105 OTC MONOGRAPH NOT FINAL part352 Walgreen Company AVOBENZONE; OXYBENZONE; OCTINOXATE 3; 2; 10 g/100g; g/100g; g/100g N 20181231 0363-0699_78bfdcd5-44ad-4c5c-bba1-90afa43b037b 0363-0699 HUMAN OTC DRUG Wal itin Loratadine TABLET ORAL 20090213 ANDA ANDA076301 Walgreen Company LORATADINE 10 mg/1 N 20181231 0363-0700_a62e3294-abd6-48dc-81b1-62a809bdc968 0363-0700 HUMAN OTC DRUG Walgreens Sterile Soothing Eye Wash Purified water LIQUID OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Walgreens WATER 99.05 mL/100mL N 20181231 0363-0701_89252d2b-bd02-4672-b22a-20f958c86905 0363-0701 HUMAN OTC DRUG Acid Controller Famotidine TABLET ORAL 20060926 ANDA ANDA077351 Walgreen Company FAMOTIDINE 20 mg/1 N 20181231 0363-0702_46cb3ab0-1500-4634-9535-9e98953ad40b 0363-0702 HUMAN OTC DRUG wal tussin dm max Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20141031 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20191231 0363-0704_2675ee1a-9a81-4b02-979c-7e7c673a1d32 0363-0704 HUMAN OTC DRUG wal tussin cf cough and cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060714 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 0363-0706_0e57f1ef-462b-401e-82bb-5a1b67d0d797 0363-0706 HUMAN OTC DRUG childrens fever reducer Acetaminophen SUPPOSITORY RECTAL 20100219 ANDA ANDA070607 Walgreen Company ACETAMINOPHEN 120 mg/1 N 20181231 0363-0707_a049607d-f5b1-4cdd-ada0-71003dd843ab 0363-0707 HUMAN OTC DRUG wal hist 12 hour relief Clemastine fumarate TABLET ORAL 19960531 ANDA ANDA074512 Walgreen Company CLEMASTINE FUMARATE 1.34 mg/1 N 20181231 0363-0708_fe194f72-c6e4-4465-bf4b-f9295257574f 0363-0708 HUMAN OTC DRUG childrens wal tap dm cough and cold Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20070309 OTC MONOGRAPH FINAL part341 Walgreen Company BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 0363-0709_93728360-35a5-460e-b445-5d3a002614b9 0363-0709 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20130322 ANDA ANDA091354 Walgreen Company NICOTINE 4 mg/1 N 20181231 0363-0710_4e64e040-1662-4dc9-b33f-3e119e0b3f7b 0363-0710 HUMAN OTC DRUG childrens Allergy Dye Free Wal Dryl Diphenhydramine hydrochloride LIQUID ORAL 20170831 OTC MONOGRAPH FINAL part341 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 0363-0711_f860fb86-b82c-4f70-aa10-4ad86ae2c5cc 0363-0711 HUMAN OTC DRUG pain reliever extra strength Acetaminophen CAPSULE, LIQUID FILLED ORAL 20160430 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 500 mg/1 N 20181231 0363-0713_6f1dcfda-c12a-4c3b-80a2-c9e15517c88f 0363-0713 HUMAN OTC DRUG Acid Reducer Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20160129 ANDA ANDA077355 Walgreen Company FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 0363-0718_91e836d3-a124-4155-853b-bf03dbe8bcf8 0363-0718 HUMAN OTC DRUG Daytime Mucus Relief Severe Cold Nighttime Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl,Guaifenesin KIT 20160531 OTC MONOGRAPH FINAL part341 Walgreens N 20181231 0363-0719_bf639cc0-4723-43cc-b792-b5f5db2bc68d 0363-0719 HUMAN OTC DRUG Mucus Relief Cold Flu Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20160531 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0363-0721_387894df-7aef-23da-e054-00144ff8d46c 0363-0721 HUMAN OTC DRUG Petroleum Jelly White Petrolatum JELLY TOPICAL 20160614 OTC MONOGRAPH FINAL part347 Walgreens PETROLATUM 100 g/100g N 20181231 0363-0721_3878aa1d-3ee5-6883-e054-00144ff88e88 0363-0721 HUMAN OTC DRUG Petroleum Jelly White Petrolatum JELLY TOPICAL 20160614 OTC MONOGRAPH FINAL part347 Walgreens PETROLATUM 100 g/100g N 20181231 0363-0721_88d61033-ccda-4dd8-bb1b-f5c5f37b28ec 0363-0721 HUMAN OTC DRUG Petroleum Jelly White Petrolatum JELLY TOPICAL 20160614 OTC MONOGRAPH FINAL part347 Walgreens PETROLATUM 100 g/100g N 20181231 0363-0723_d4ab6de9-00f3-480d-bb5c-568069cfcac8 0363-0723 HUMAN OTC DRUG Daytime Nighttime Sinus Relief Maximum Strength Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl,Guaifenesin KIT 20160531 OTC MONOGRAPH FINAL part341 Walgreens N 20181231 0363-0725_8442e7de-7ea2-4939-bc35-99345f42796a 0363-0725 HUMAN OTC DRUG Loratadine and Pseudoephedrine Loratadine and Pseudoephedrine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131107 ANDA ANDA076557 Walgreen Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 0363-0730_2d2bf4f5-6191-4128-8c1d-1fdd1fd0c4d5 0363-0730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20001201 ANDA ANDA074164 Walgreen Company MICONAZOLE NITRATE 20 mg/g N 20181231 0363-0731_1847f0f6-e882-4c4a-a9ac-3da0ad27f9e8 0363-0731 HUMAN OTC DRUG Baby Petroleum Petrolatum JELLY TOPICAL 20140717 OTC MONOGRAPH FINAL part347 Walgreen Company PETROLATUM 100 g/100g N 20181231 0363-0732_8753a131-f8b1-48e1-993b-73c1ee635fef 0363-0732 HUMAN OTC DRUG Omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate CAPSULE, GELATIN COATED ORAL 20160715 ANDA ANDA201361 Walgreen Company OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 N 20181231 0363-0734_bec20f09-85f1-40df-a9f5-a202d79d5da3 0363-0734 HUMAN OTC DRUG nicotine mini Nicotine Polacrilex LOZENGE ORAL 20130119 ANDA ANDA203690 Walgreen Company NICOTINE 2 mg/1 N 20181231 0363-0735_aa19972a-169b-47a0-afe1-e73d378b78e3 0363-0735 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160428 ANDA ANDA091070 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20191231 0363-0737_7beb5130-6a63-4bbf-b6fb-a1f899158bc4 0363-0737 HUMAN OTC DRUG Miconazole 1 Miconazole nitrate KIT 20100608 ANDA ANDA079114 Walgreen Company N 20181231 0363-0739_f6150a67-4214-3f90-63c3-b71084320909 0363-0739 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202194 Walgreen Co LANSOPRAZOLE 15 mg/1 N 20181231 0363-0740_38785540-228b-5d3e-e054-00144ff88e88 0363-0740 HUMAN OTC DRUG Shea Butter Petroleum Jelly Petrolatum Jelly JELLY TOPICAL 20160614 OTC MONOGRAPH FINAL part347 Walgreens PETROLATUM 99.6 g/100g N 20181231 0363-0745_35f6edb5-923c-4bf7-ab23-31bad90448ac 0363-0745 HUMAN OTC DRUG childrens Wal Tussin Cough and Cold chlorpheniramine maleate, dextrometrorphan HBr LIQUID ORAL 20170830 OTC MONOGRAPH FINAL part341 WALGREEN CO. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 2; 15 mg/10mL; mg/10mL N 20181231 0363-0751_c4275005-542d-4af1-9e42-bac989d69e12 0363-0751 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20090109 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0363-0758_385a1e0b-09c5-4f2d-8404-086020e5c891 0363-0758 HUMAN OTC DRUG Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strength Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20170908 OTC MONOGRAPH FINAL part341 WALGREEN CO. DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/20mL; mg/20mL N 20181231 0363-0760_1ffeb1c0-ebd2-42e3-ad62-6d37bfbf261c 0363-0760 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20150831 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0363-0763_f9ef3cf2-f89e-4ac6-9ec9-ff4db312c0ff 0363-0763 HUMAN OTC DRUG Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20131121 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 0363-0766_48ba5e49-269f-4f3d-aca8-9387d4febd86 0363-0766 HUMAN OTC DRUG pain and fever Acetaminophen LIQUID ORAL 20111104 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0773_a67aeb11-89f0-4f62-8348-414dc7d23444 0363-0773 HUMAN OTC DRUG Walgreens Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20010423 UNAPPROVED DRUG OTHER Walgreens Co PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 0363-0777_436b1a80-abea-464b-a645-6fe63001d6a5 0363-0777 HUMAN OTC DRUG First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20160902 OTC MONOGRAPH NOT FINAL part333E Walgreens POVIDONE-IODINE 10 mg/mL N 20181231 0363-0782_9333e9fb-43a4-4923-9c6c-3ba043cd0545 0363-0782 HUMAN OTC DRUG Mucus Relief Maximum StrengthCold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20170531 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 0363-0784_df0fc5e5-6708-71e9-f399-745c6965cd04 0363-0784 HUMAN OTC DRUG Wal-Fex Fexofenadine hydrochloride TABLET ORAL 20110413 ANDA ANDA076502 Walgreens Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 0363-0785_c6ff0c44-e819-4488-90f0-a7014e798704 0363-0785 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20151130 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 0363-0789_cea507f3-86d6-4a68-9635-c4e4ca0f8fda 0363-0789 HUMAN OTC DRUG childrens Multi Symptom Fever and Cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20170901 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 0363-0790_05d2a37f-f47d-40e6-a799-120d846bf5d6 0363-0790 HUMAN OTC DRUG Walgreens Infants Dye Free Gas Relief Simethicone EMULSION ORAL 20170830 OTC MONOGRAPH FINAL part332 WALGREEN CO. DIMETHICONE 20 mg/.3mL N 20181231 0363-0791_87cf3911-4baf-4c62-8a43-4d920a0f3ff5 0363-0791 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20170726 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g N 20181231 0363-0798_cf2f5b26-c930-4f78-af4a-836328120eb1 0363-0798 HUMAN OTC DRUG minoxidil for men Minoxidil SOLUTION TOPICAL 20091113 ANDA ANDA075598 Walgreen Company MINOXIDIL 3 g/60mL N 20181231 0363-0799_949ecc3f-49da-4fca-83d6-44613584651b 0363-0799 HUMAN OTC DRUG wal tussin cough and chest congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100126 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL N 20181231 0363-0800_af0f69fb-017f-4b89-ad29-aca09b810615 0363-0800 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 19931008 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0801_6f21aa14-8840-4842-aa01-2535a1b450f9 0363-0801 HUMAN OTC DRUG Well at Walgreens SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION ORAL 20130401 UNAPPROVED DRUG OTHER Walgreen Company SODIUM BICARBONATE; SODIUM CHLORIDE 700; 2300 mg/3000mg; mg/3000mg N 20181231 0363-0802_29d4e6d1-6c70-4305-8303-1cf6703e8ad9 0363-0802 HUMAN OTC DRUG Well at Walgreens SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION NASAL 20130401 UNAPPROVED DRUG OTHER Walgreen Company SODIUM BICARBONATE; SODIUM CHLORIDE 700; 2300 mg/3000mg; mg/3000mg N 20181231 0363-0803_126fec95-3c26-4b45-a53d-d3193d331812 0363-0803 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20160623 OTC MONOGRAPH FINAL part347 Walgreens Co WITCH HAZEL 841 mg/mL N 20181231 0363-0804_81683bb6-27da-4b89-8599-2229830ae1dc 0363-0804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19910315 OTC MONOGRAPH NOT FINAL part333A Walgreen Co ISOPROPYL ALCOHOL .91 mg/mL N 20181231 0363-0806_39c99c84-c57e-4fc3-95e5-aa723b003fb3 0363-0806 HUMAN OTC DRUG Childrens Ibuprofen 100 Dye Free Ibuprofen SUSPENSION ORAL 20140224 ANDA ANDA074937 Walgreen Company IBUPROFEN 100 mg/5mL N 20181231 0363-0807_b11e80ab-def7-4372-8428-fa8663da9cbb 0363-0807 HUMAN OTC DRUG Cold and Flu Nighttime D Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Pseudoephedrine HCl SOLUTION ORAL 20140205 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1000; 30; 12.5; 60 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 0363-0809_e0f12d59-1d59-4374-b74f-ea16eafec66a 0363-0809 HUMAN OTC DRUG Walgreen Alcohol Isopropyl Alcohol SWAB TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Walgreen Company ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 0363-0810_298b1eeb-c214-4d67-8c7f-4682bac2cf23 0363-0810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 19891015 OTC MONOGRAPH NOT FINAL part333A Walgreens, CO. ISOPROPYL ALCOHOL 500 mg/mL N 20181231 0363-0811_439eb788-b3a8-4791-bab6-0e65fa5f2d5a 0363-0811 HUMAN OTC DRUG Allergy Nasal Triamcinolone acetonide SPRAY, METERED NASAL 20160410 ANDA ANDA078104 Walgreen Company TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 0363-0815_a3c5128b-208f-43cd-9cd7-c0287566ea10 0363-0815 HUMAN OTC DRUG Walgreens Advanced Anti-Wrinkle and Firming Day Cream Broad Spectrum SPF18 Sunscreen Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20121215 OTC MONOGRAPH NOT FINAL part352 Walgreen Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g N 20181231 0363-0819_39f876d3-9029-4a5a-b819-c908306ad544 0363-0819 HUMAN OTC DRUG Walgreens Medicated Callus Removers SALICYLIC ACID DISC TOPICAL 20130601 OTC MONOGRAPH FINAL part358F WALGREENS Co. SALICYLIC ACID 17.67 mg/1 N 20181231 0363-0823_014da88d-a6cf-4738-9b95-25dfbe805e25 0363-0823 HUMAN OTC DRUG Triple Antibiotic with Pain Relief Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride OINTMENT TOPICAL 20100312 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 0363-0826_3d5bd0aa-c849-40b0-a312-fbe9932512da 0363-0826 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160315 OTC MONOGRAPH NOT FINAL part333A Walgreen CO. ALCOHOL 567 mg/mL N 20181231 0363-0828_d8a8b76f-c6e5-40f8-bddc-350d4cca9e5e 0363-0828 HUMAN OTC DRUG WALGREENS PINK GRAPEFRUIT SALICYLIC ACID LIQUID TOPICAL 20131217 OTC MONOGRAPH FINAL part333D WALGREEN COMPANY SALICYLIC ACID 20 mg/mL N 20181231 0363-0829_46ad4e76-2d6a-4b77-87ac-0cc51ba6f724 0363-0829 HUMAN OTC DRUG WELL AT WALGREENS PINK GRAPEFRUIT SALICYLIC ACID LIQUID TOPICAL 20160316 OTC MONOGRAPH FINAL part333D WALGREEN COMPANY SALICYLIC ACID 20 mg/mL N 20181231 0363-0830_54a006c4-959e-40e0-ab9c-d3a34add95c7 0363-0830 HUMAN OTC DRUG Well at Walgreens Blemish and Blackhead Control Apricot Salicylic Acid LIQUID TOPICAL 20180105 OTC MONOGRAPH FINAL part333D Walgreen Company SALICYLIC ACID .02 g/g N 20191231 0363-0831_fa2773d6-56dc-4e3d-8e86-fd18b9ab7345 0363-0831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19940616 OTC MONOGRAPH NOT FINAL part334 Walgreen Co MINERAL OIL 999 mg/mL N 20181231 0363-0834_86889557-8b8e-4cb6-8102-abcee7178b3d 0363-0834 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20161130 OTC MONOGRAPH NOT FINAL part334 Walgreens MINERAL OIL 100 mg/100mL N 20181231 0363-0835_28b01cc6-6b28-4e92-a51b-49e5924bb48c 0363-0835 HUMAN OTC DRUG Walgreens Intense Toothache Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B walgreens BENZOCAINE 20 g/100g N 20181231 0363-0838_0a65ae0f-b829-46b1-9e6d-4a9fae91eb68 0363-0838 HUMAN OTC DRUG Severe Oral Pain Reliever Benzocaine LIQUID ORAL 20120110 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 20 g/100g N 20181231 0363-0839_17c7f81a-5c16-4ed4-9b0b-b40ab320f769 0363-0839 HUMAN OTC DRUG Severe Cold and Flu acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20131121 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0363-0841_37d6b3e1-ceb2-4b08-885c-af28c84f77d1 0363-0841 HUMAN OTC DRUG First Aid Antibiotic Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20170216 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 0363-0843_ce140374-4b4b-445d-a29c-b0b3bac49a6e 0363-0843 HUMAN OTC DRUG Hemorrhoidal Cooling Phenylephrine HCl, Witch hazel GEL TOPICAL 20110719 OTC MONOGRAPH FINAL part346 Walgreen Company PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g N 20181231 0363-0845_0f64b36e-8576-4dc4-88ec-218b31aeb5e8 0363-0845 HUMAN OTC DRUG 70% Rubbing Isopropyl Alcohol LIQUID TOPICAL 20090511 OTC MONOGRAPH NOT FINAL part333A Walgreen C0 ISOPROPYL ALCOHOL 500 mg/mL N 20181231 0363-0851_7fb78bdd-7c05-4647-ac94-820318c90242 0363-0851 HUMAN OTC DRUG Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20021120 OTC MONOGRAPH FINAL part332 Walgreen Company ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 0363-0854_7f312f5c-10b1-4eaf-8f00-690b9d99deb6 0363-0854 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20070910 ANDA ANDA078546 Walgreen Company NICOTINE 4 mg/1 N 20181231 0363-0855_52f7ebb9-dca0-4b3e-821b-f7f84e033760 0363-0855 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20140124 OTC MONOGRAPH NOT FINAL part356 Walgreen Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0363-0857_1bbc3c51-0776-429e-99b4-b80b02fdaf2e 0363-0857 HUMAN OTC DRUG Clotrimazole Antifungal Clotrimazole CREAM TOPICAL 20170929 OTC MONOGRAPH FINAL part333C Walgreen Company CLOTRIMAZOLE 1 g/100g N 20181231 0363-0862_7fd3d048-4823-4758-bb48-e47d4498bb28 0363-0862 HUMAN OTC DRUG Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI, Acetaminophen, Diphenhydramine HCI KIT 20150731 OTC MONOGRAPH FINAL part341 Walgreens N 20181231 0363-0866_7d455b3a-3c42-4052-953f-dd16ef9d4380 0363-0866 HUMAN OTC DRUG lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070910 OTC MONOGRAPH FINAL part358G Walgreen Company PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 0363-0871_f251c6ee-b8e6-4194-a020-a98991066465 0363-0871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19960327 OTC MONOGRAPH NOT FINAL part333A Walgreens Co. HYDROGEN PEROXIDE 30 mg/mL N 20181231 0363-0873_428fcd49-d8a1-4f29-a524-133cfa240165 0363-0873 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20060223 ANDA ANDA077007 Walgreen Company NICOTINE 4 mg/1 N 20181231 0363-0875_63a0704a-c310-fd90-e053-2a91aa0afe29 0363-0875 HUMAN OTC DRUG Walgreens Effervescent Cold Relief Plus Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20141024 OTC MONOGRAPH FINAL part341 Walgreens ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 N 20191231 0363-0876_b0cc8b8e-a686-4996-81f1-e95f35f8a897 0363-0876 HUMAN OTC DRUG Ethyl Rubbing Alcohol Ethyl Alcohol LIQUID TOPICAL 20090518 OTC MONOGRAPH NOT FINAL part333A Walgreens ALCOHOL 610 mg/mL N 20181231 0363-0878_27b0ac5e-ada2-4f85-995a-862f0a481ffb 0363-0878 HUMAN OTC DRUG anti itch Hydrocortisone LOTION TOPICAL 20120327 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g N 20181231 0363-0881_3ac3fc95-6871-4f87-accc-bfc03790a083 0363-0881 HUMAN OTC DRUG Allergy Nasal Fluticasone Propionate SPRAY, METERED NASAL 20160712 ANDA ANDA207957 Walgreen Company FLUTICASONE PROPIONATE 50 ug/1 N 20191231 0363-0889_c01307de-f13a-42ca-93d3-cc561b3aa8be 0363-0889 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 19891215 OTC MONOGRAPH FINAL part347 Walgreen Co PETROLATUM 1 mg/g N 20181231 0363-0897_31b4adda-a185-42ce-9859-f26e9d41b65a 0363-0897 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990311 ANDA ANDA074937 Walgreen Company IBUPROFEN 100 mg/5mL N 20181231 0363-0898_e3ddd45c-fda1-4d26-97d0-8b8bd57393bb 0363-0898 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160404 OTC MONOGRAPH NOT FINAL part333A Walgreen ALCOHOL 567 mg/mL N 20181231 0363-0899_83093f1e-d7ff-4ddd-a6a1-08dac11e53a3 0363-0899 HUMAN OTC DRUG childrens cough dm Dextromethorphan polistirex SUSPENSION ORAL 20150612 ANDA ANDA091135 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20191231 0363-0901_f7db348d-7a57-4514-96f7-2879562ded75 0363-0901 HUMAN OTC DRUG Baby TALC POWDER TOPICAL 20140717 OTC MONOGRAPH NOT FINAL part347 Walgreen Company TALC 100 g/100g N 20181231 0363-0903_89f4d5e6-4a13-4d85-9925-a083cc90fe6c 0363-0903 HUMAN OTC DRUG Wal Fex Fexofenadine HCl TABLET, FILM COATED ORAL 20110822 ANDA ANDA076447 Walgreen Company FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 0363-0909_f2a30365-b3dd-4360-8998-e5277d4d17b7 0363-0909 HUMAN OTC DRUG Ibuprofen Sodium Ibuprofen TABLET, FILM COATED ORAL 20160113 ANDA ANDA206581 Walgreen Company IBUPROFEN SODIUM 256 mg/1 N 20181231 0363-0910_36afb16b-b300-4486-b15a-aae6b402af8a 0363-0910 HUMAN OTC DRUG Ibuprofen Sodium Ibuprofen TABLET, FILM COATED ORAL 20160113 20180824 ANDA ANDA206581 Walgreen Company IBUPROFEN SODIUM 256 mg/1 N 20191231 0363-0910_670b289f-89a4-4838-a8f4-2048d415bcdf 0363-0910 HUMAN OTC DRUG Charcoal Blackhead Clearing Scrub Salicylic Acid CREAM TOPICAL 20160301 OTC MONOGRAPH FINAL part333D Walgreen Co SALICYLIC ACID 20.6 mg/mL N 20191231 0363-0911_c6782f34-7d88-413b-aab7-73e1d2a683c4 0363-0911 HUMAN OTC DRUG Pure Cornstarch Baby Corn Starch POWDER TOPICAL 20140717 OTC MONOGRAPH NOT FINAL part348 Walgreen Company STARCH, CORN 99 g/100g N 20181231 0363-0912_2a56a8de-a28f-4781-9fa4-cdb5b403ee53 0363-0912 HUMAN OTC DRUG Cold and Cough MULTI-SYMPTOM DAYTIME / NIGHTTIME Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl KIT 20070222 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-0915_09b31bc2-277a-4b6a-839b-ebd587d86d7e 0363-0915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080227 NDA NDA022032 Walgreen Company OMEPRAZOLE 20 mg/1 N 20181231 0363-0916_6225f254-d777-4933-9e61-8c1e7fe12ee1 0363-0916 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20111215 ANDA ANDA079114 Walgreen Company N 20181231 0363-0917_b684478f-3c1c-4c7e-84d7-615ed21e5d5f 0363-0917 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20131227 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 0363-0918_95ab0fa0-9c3c-48bd-a9bd-cb41798d1c1f 0363-0918 HUMAN OTC DRUG WalTussin DM Max Dextromethorphan HBr, Doxylamine Succinate, Guaifenesin KIT 20160710 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-0919_bcdeb691-a45d-49df-82c5-854271a4d374 0363-0919 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20140318 ANDA ANDA076779 Walgreen Company NICOTINE 4 mg/1 N 20191231 0363-0926_da088fb9-233d-4baa-9a38-eabef3541d99 0363-0926 HUMAN OTC DRUG Walgreens Chap Aid Cherry Lip Balm Padimate O, Petrolatum STICK TOPICAL 20010424 OTC MONOGRAPH NOT FINAL part352 Walgreen Company PADIMATE O; PETROLATUM 15; 450 mg/g; mg/g N 20181231 0363-0927_5e7e6ba8-45e7-439d-9b03-1a7749d5096d 0363-0927 HUMAN OTC DRUG Walgreens Chap Aid Regular Lip Balm Padimate O, Petrolatum STICK TOPICAL 20000815 OTC MONOGRAPH NOT FINAL part352 Walgreen Company PADIMATE O; PETROLATUM 15; 450 mg/g; mg/g N 20181231 0363-0929_f777bc3f-f34f-4654-a801-82e3c2b0090f 0363-0929 HUMAN OTC DRUG Wal Zyr D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20131206 ANDA ANDA077170 Walgreen Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 0363-0930_4590d251-9860-4ed3-b245-82169b2a1168 0363-0930 HUMAN OTC DRUG Walgreens Chap Aid Lip Balm Strawberry Padimate O, Petrolatum STICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Walgreen Company PADIMATE O; PETROLATUM 15; 450 mg/g; mg/g N 20181231 0363-0934_ec521461-a427-4722-8c38-9fa08c9df46f 0363-0934 HUMAN OTC DRUG wal tussin dm max cough and chest congestion dextromethorphan hbr, guaifenesin SUSPENSION ORAL 20120119 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 0363-0938_647385fa-0b8a-45d7-bb9e-1714b19b9e7f 0363-0938 HUMAN OTC DRUG all day pain relief Naproxen Sodium TABLET ORAL 20140731 ANDA ANDA074661 Walgreen Company NAPROXEN SODIUM 200 mg/1 N 20181231 0363-0939_2b95682b-155a-1234-e054-00144ff88e88 0363-0939 HUMAN OTC DRUG Apothecary PVP Topical Povidone-Iodine SOLUTION TOPICAL 20110613 OTC MONOGRAPH NOT FINAL part333A Walgreen Company POVIDONE-IODINE 1 g/100mL E 20171231 0363-0941_acc7e900-84e8-4e70-bf5d-d6f0665c9a5e 0363-0941 HUMAN OTC DRUG Advanced Healing Petrolatum OINTMENT TOPICAL 20080328 OTC MONOGRAPH FINAL part347 Walgreen Co PETROLATUM .34 g/g N 20181231 0363-0942_baa4e693-0790-41fb-b4d5-c3feb0db03b0 0363-0942 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20150713 OTC MONOGRAPH NOT FINAL part334 Walgreens MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 0363-0944_f303936e-e00e-4956-9af6-1331a4648f7b 0363-0944 HUMAN OTC DRUG hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20110117 OTC MONOGRAPH FINAL part346 Walgreen Company GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 0363-0946_85303b49-c109-4c71-969a-0e81ad8ab927 0363-0946 HUMAN OTC DRUG pain and fever infants Acetaminophen SUSPENSION ORAL 20110822 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0947_89165575-d216-43e5-9835-4c5acdb5baba 0363-0947 HUMAN OTC DRUG Oil Free Acne Wash Salicylic Acid 2% LOTION TOPICAL 20141120 OTC MONOGRAPH FINAL part333D Walgreen Co SALICYLIC ACID 20.6 mg/mL N 20181231 0363-0949_5929bfd5-08e0-41b2-9f38-b1e1686e5bc0 0363-0949 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20130508 OTC MONOGRAPH NOT FINAL part334 Walgreen Company MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0363-0950_07822d51-e56f-4657-88c7-c5a04d708b7a 0363-0950 HUMAN OTC DRUG wal zan 150 Ranitidine TABLET, FILM COATED ORAL 20110917 ANDA ANDA091429 Walgreen Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 0363-0952_0fa3b4fc-f63d-429f-b762-051516526977 0363-0952 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130321 OTC MONOGRAPH NOT FINAL part333A Walgreen Co ALCOHOL 700 mg/mL N 20181231 0363-0953_67794f96-8f59-438a-aa5e-ac3ef5ee50fb 0363-0953 HUMAN OTC DRUG Childrens Dye Free Wal Zyr Cetirizine HCl SOLUTION ORAL 20171019 ANDA ANDA204226 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0363-0955_f7729400-f67e-442f-b4b9-2f221932b0ae 0363-0955 HUMAN OTC DRUG lice treatment Permethrin LOTION TOPICAL 20100715 ANDA ANDA076090 Walgreen Company PERMETHRIN 1 mg/100mL N 20181231 0363-0957_7583c2e3-2e8d-41c5-a687-092163e2d0ad 0363-0957 HUMAN OTC DRUG Nicotine mini Nicotine Polacrilex LOZENGE ORAL 20130119 ANDA ANDA203690 Walgreen Company NICOTINE 4 mg/1 N 20181231 0363-0958_b8cc6873-a6c3-4301-92c2-331215d81e49 0363-0958 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130614 ANDA ANDA091135 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 0363-0964_568a89c7-ba33-4759-bd33-9b4afff6b941 0363-0964 HUMAN OTC DRUG wal flu severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20151105 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 0363-0971_8cb679a8-8658-4d42-9908-62d5811b0c27 0363-0971 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 20100215 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0973_5ee43bd9-252c-47f6-a2ee-c2313dbda35a 0363-0973 HUMAN OTC DRUG Hydrocortisone Plus 10 Moisturizers hydrocortisone CREAM TOPICAL 20150827 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g N 20181231 0363-0974_f8ff3f53-dde7-4500-bbf5-ac9847b81e64 0363-0974 HUMAN OTC DRUG Childrens Wal Zyr Allergy cetirizine hydrochloride SOLUTION ORAL 20080425 ANDA ANDA090254 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0363-0984_81df5a8b-46ca-4590-915e-886ee3fa28cc 0363-0984 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part333A WALGREEN CO. ALCOHOL 567 mg/mL N 20181231 0363-0995_2fcd948c-3fbb-4c20-8c84-79b8f1cd37d6 0363-0995 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19960125 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL N 20181231 0363-0999_a31ed23a-0ce4-484d-bec0-d6b73c7f9053 0363-0999 HUMAN OTC DRUG Mucus Relief Sinus Congestion Daytime Nighttime Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl, Diphenhydramine HCl KIT 20130630 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-1000_8aacc2de-d117-f1ba-eb01-c09989b0720e 0363-1000 HUMAN OTC DRUG Daytime Cold and Flu Relief Non Drowsy acetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121009 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0363-1001_3557d2e9-714a-4066-aa73-ea9e3363e574 0363-1001 HUMAN OTC DRUG Walgreens Chest Rub camphor, eucalyptus oil, menthol OINTMENT TOPICAL 20150301 OTC MONOGRAPH FINAL part341 Walgreen Company CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 48; 12; 26 mg/g; mg/g; mg/g N 20181231 0363-1003_8aacc2de-d117-f1ba-eb01-c09989b0720e 0363-1003 HUMAN OTC DRUG Daytime Cold and Flu Relief Non Drowsy acetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121009 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0363-1005_51d36d60-6c52-2493-c162-d911d20315d3 0363-1005 HUMAN OTC DRUG nighttime cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20121009 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 0363-1009_dc97d7d6-ba23-2808-ef27-4a0ce4e1e3e4 0363-1009 HUMAN OTC DRUG Day Time Night Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130301 OTC MONOGRAPH FINAL part341 Walgreens Company N 20181231 0363-1019_1742b16e-bdfa-1bb2-eb50-d82f2b18e793 0363-1019 HUMAN OTC DRUG Day Time Night Time Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine HCl KIT 20130301 OTC MONOGRAPH FINAL part341 Walgeens Company N 20181231 0363-1020_6f223307-ed4d-41e8-9ac1-128bbdc9a8a6 0363-1020 HUMAN OTC DRUG Zinc Oxide ZINC OXIDE PASTE TOPICAL 20080324 OTC MONOGRAPH FINAL part347 Walgreen Co ZINC OXIDE 532 mg/g N 20181231 0363-1024_5f93c42a-b442-73d1-ff50-89747df33da9 0363-1024 HUMAN OTC DRUG Wal-Zyr Wal-Zyr TABLET ORAL 20140902 ANDA ANDA078317 Walgreen Company CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0363-1029_4b3b5882-7386-7c65-38ce-9643fa4ef19c 0363-1029 HUMAN OTC DRUG Wal-Zan Wal-Zan TABLET ORAL 20150731 ANDA ANDA075167 Walgreens Company RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 0363-1030_3c367ba7-ebc9-575a-d792-4e2b35560b3f 0363-1030 HUMAN OTC DRUG Wal-Zan Wal-Zan TABLET ORAL 20150731 ANDA ANDA200172 Walgreens Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 0363-1031_6d608777-5faa-1d37-8e50-497e46325fb9 0363-1031 HUMAN OTC DRUG Multi-Symptom Daytime and Nighttime Cold and Flu Relief Plus Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140901 OTC MONOGRAPH FINAL part341 Walgreens Company N 20181231 0363-1035_7a727cf3-a32a-e3fe-85ca-96b3aaef4e43 0363-1035 HUMAN OTC DRUG Day Time and Night Time Sinus and Congestion Acetaminophen, Doxylamine succinate, Phenylephrine HCl KIT 20140901 OTC MONOGRAPH FINAL part341 Walgreens Company N 20181231 0363-1040_7ae9f188-c00c-a4c7-a3aa-91357dfd0a1d 0363-1040 HUMAN OTC DRUG Cetirizine Cetirizine CAPSULE, LIQUID FILLED ORAL 20170703 ANDA ANDA207235 Walgreens CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0363-1061_47937ef4-f3c5-6a4c-e054-00144ff88e88 0363-1061 HUMAN OTC DRUG Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% LIQUID TOPICAL 20110501 NDA NDA019125 Walgreen Co. CHLORHEXIDINE GLUCONATE 4 mg/100mL N 20181231 0363-1070_464f6645-ca34-1722-e054-00144ff8d46c 0363-1070 HUMAN OTC DRUG Menthol Cough Drop menthol LOZENGE ORAL 20160605 OTC MONOGRAPH FINAL part341 Walgreens MENTHOL 5.4 mg/1 N 20181231 0363-1071_47522852-005b-2a66-e054-00144ff8d46c 0363-1071 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20160605 OTC MONOGRAPH FINAL part341 Walgreen Co. MENTHOL 5.8 mg/1 N 20181231 0363-1072_47653657-80b6-482f-e054-00144ff88e88 0363-1072 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20160605 OTC MONOGRAPH FINAL part341 Walgreens Co, MENTHOL 7.5 mg/1 N 20181231 0363-1073_4766afa8-fdb0-05e5-e054-00144ff8d46c 0363-1073 HUMAN OTC DRUG Strawberry Cough Drop Menthol 2.7 mg LOZENGE ORAL 20160605 OTC MONOGRAPH FINAL part341 Walgreen Co. MENTHOL 2.7 mg/1 N 20181231 0363-1074_4767271e-0b02-1e56-e054-00144ff88e88 0363-1074 HUMAN OTC DRUG Herbal Cough Drops Menthol LOZENGE ORAL 20160605 OTC MONOGRAPH FINAL part341 Walgreen Co. MENTHOL 4.8 mg/1 N 20181231 0363-1075_476b47e6-18e5-693c-e054-00144ff8d46c 0363-1075 HUMAN OTC DRUG SF Menthol Cough Drops Menthol LOZENGE ORAL 20160605 OTC MONOGRAPH FINAL part341 Walgreen Co. MENTHOL 5.8 mg/1 N 20181231 0363-1076_477c25ec-33da-04a6-e054-00144ff8d46c 0363-1076 HUMAN OTC DRUG SF Cherry Cough Drop Menthol LOZENGE ORAL 20160605 OTC MONOGRAPH FINAL part341 Walgreen Co. MENTHOL 5.8 mg/1 N 20181231 0363-1077_477cedee-6bd4-2a34-e054-00144ff8d46c 0363-1077 HUMAN OTC DRUG SF Honey Lemon Cough Drop Menthol LOZENGE ORAL 20160605 OTC MONOGRAPH FINAL part341 Walgreen Co. MENTHOL 7.6 mg/1 N 20181231 0363-1078_477d741c-4f9c-4eb2-e054-00144ff8d46c 0363-1078 HUMAN OTC DRUG Sore Throat Lollipops Pectin LOZENGE ORAL 20160605 OTC MONOGRAPH NOT FINAL part356 Walgreen Co. PECTIN 10 mg/1 N 20181231 0363-1079_47e0f809-0b31-2b23-e054-00144ff8d46c 0363-1079 HUMAN OTC DRUG Cherry Sore Throat Lozenge Benzocaine LOZENGE ORAL 20160415 OTC MONOGRAPH NOT FINAL part356 Walgreens Co. BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 0363-1080_44e4d386-bd27-05aa-e054-00144ff88e88 0363-1080 HUMAN OTC DRUG Mixed Berry Sore Throat and Cough Lozenge Benzocaine LOZENGE ORAL 20160119 OTC MONOGRAPH NOT FINAL part356 Walgreen Company BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20181231 0363-1081_479284ad-ec03-4b74-e054-00144ff8d46c 0363-1081 HUMAN OTC DRUG Antacid Soft Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20150105 OTC MONOGRAPH FINAL part331 Walgreen Co. CALCIUM CARBONATE 1177 mg/1 N 20181231 0363-1082_47dfbe23-f408-6588-e054-00144ff8d46c 0363-1082 HUMAN OTC DRUG Antacid Flavor Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20150615 OTC MONOGRAPH FINAL part331 Walgreen Co. CALCIUM CARBONATE 750 mg/1 N 20181231 0363-1083_47e0830f-31e8-5ff0-e054-00144ff88e88 0363-1083 HUMAN OTC DRUG Antacid Flavor Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20151130 OTC MONOGRAPH FINAL part331 Walgreen Co. CALCIUM CARBONATE 750 mg/1 N 20181231 0363-1084_477ac101-1049-2f0c-e054-00144ff8d46c 0363-1084 HUMAN OTC DRUG Menthol Cough Drop menthol LOZENGE ORAL 20160605 OTC MONOGRAPH FINAL part341 Walgreens MENTHOL 5.4 mg/1 N 20181231 0363-1085_477b9fc3-c3c6-647e-e054-00144ff8d46c 0363-1085 HUMAN OTC DRUG SF Menthol Cough Drop Menthol LOZENGE ORAL 20160605 OTC MONOGRAPH FINAL part341 Walgreen Co. MENTHOL 5.8 mg/1 N 20181231 0363-1086_47f38e79-c731-21b9-e054-00144ff88e88 0363-1086 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20160605 OTC MONOGRAPH FINAL part341 Walgreen Co. MENTHOL 5.8 mg/1 N 20181231 0363-1087_47f89d33-6e0b-4bb4-e054-00144ff88e88 0363-1087 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20160605 OTC MONOGRAPH FINAL part341 Walgreen Co. MENTHOL 7.5 mg/1 N 20181231 0363-1088_487ff808-9a35-4480-e054-00144ff8d46c 0363-1088 HUMAN OTC DRUG Honey Lemon Throat Drops Benzocaine LOZENGE ORAL 20170214 OTC MONOGRAPH NOT FINAL part356 Walgreens BENZOCAINE; MENTHOL 15; 2.6 mg/1; mg/1 N 20181231 0363-1089_4b4268db-838d-474c-e054-00144ff8d46c 0363-1089 HUMAN OTC DRUG Honey cough drop menthol LOZENGE ORAL 20170321 OTC MONOGRAPH FINAL part341 Walgreen Company MENTHOL 2.7 mg/1 N 20181231 0363-1090_4bbc6a99-d1dd-4cdb-e054-00144ff8d46c 0363-1090 HUMAN OTC DRUG cold relief Zinc Gluconate LOZENGE ORAL 20150611 UNAPPROVED HOMEOPATHIC Walgreen Company ZINC GLUCONATE 2 [hp_X]/1 N 20181231 0363-1091_4d75fcbc-7fc5-6884-e054-00144ff8d46c 0363-1091 HUMAN OTC DRUG Cold Relief Lozenges Zincum Gluconicum LOZENGE ORAL 20150611 UNAPPROVED HOMEOPATHIC Walgreens Company ZINC GLUCONATE 2 [hp_X]/1 N 20181231 0363-1092_53940d3b-4600-00d1-e054-00144ff8d46c 0363-1092 HUMAN OTC DRUG Pectin Pops Pectin LOZENGE ORAL 20170705 OTC MONOGRAPH NOT FINAL part356 Walgreen Co. PECTIN 10 mg/1 N 20181231 0363-1100_2655a37a-6044-501b-e054-00144ff88e88 0363-1100 HUMAN OTC DRUG Walgreens Daytime Wal-Flu Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20130515 OTC MONOGRAPH FINAL part341 Walgreen Co. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 0363-1101_267ca7df-1a15-6d1b-e054-00144ff88e88 0363-1101 HUMAN OTC DRUG Walgreens night time wal-flu severe cold and cough honey lemon flavor infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20131008 OTC MONOGRAPH FINAL part341 Walgreen Co. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 0363-1102_266680c2-4176-6a99-e054-00144ff8d46c 0363-1102 HUMAN OTC DRUG Walgreens Daytime Nighttime Wal-Flu Severe Cold and Cough Kit Acetaminophen, Diphenhydramine HCL, Phenylephrine HCL and Dextromethorphan HBr KIT 20140618 OTC MONOGRAPH FINAL part341 Walgreen Co. N 20181231 0363-1103_267ace69-bb22-482f-e054-00144ff8d46c 0363-1103 HUMAN OTC DRUG Well at Walgreens Multi-Symptom Wal-Flu Severe Cold and Nighttime Wal-Flu Severe Cold and Cough Kit Acetaminophen, Diphenhydramine HCL, Phenylephrine HCL and Dextromethorphan HBr KIT 20150611 OTC MONOGRAPH FINAL part341 Walgreen Co. N 20181231 0363-1104_267a19ca-b39e-05b8-e054-00144ff88e88 0363-1104 HUMAN OTC DRUG Well At Walgreens Multi-Symptom Severe Cold Green Tea and Honey Lemon flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20150609 OTC MONOGRAPH FINAL part341 Walgreens Co. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 0363-1105_1dbdadcd-4878-4071-9ce1-714e55c5453e 0363-1105 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20140531 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC 500 [USP'U]/g N 20181231 0363-1111_4865f4f2-7737-4b3b-85ea-09f1a0f4f445 0363-1111 HUMAN OTC DRUG CYHOT Cream with Lidocaine Well at WAlgreens Lidocaine HCI 4% Menthol 1% CREAM TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part348 Walgreens LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100mL; g/100mL N 20181231 0363-1112_90fb11e5-b5e3-43c1-98fb-7611b75fbf14 0363-1112 HUMAN OTC DRUG Pain Relieving Well at walgreens Lidocaine 4% PATCH TOPICAL 20170606 OTC MONOGRAPH NOT FINAL part348 Walgreens LIDOCAINE .3 g/1 N 20181231 0363-1114_25cfb264-0ff0-49b8-881a-8c2a40e4134d 0363-1114 HUMAN OTC DRUG Anorectal Walgreens Lidocaine CREAM TOPICAL 20160318 OTC MONOGRAPH FINAL part346 Walgrrens LIDOCAINE 5 g/100mL N 20181231 0363-1115_cb7f3592-c531-49ff-9561-8aff88af3bb7 0363-1115 HUMAN OTC DRUG Acne Spot Treatment Walgreens Salicylic Acid 2% STICK TOPICAL 20160115 OTC MONOGRAPH FINAL part333D Walgreens SALICYLIC ACID 2 g/100g N 20181231 0363-1116_fcc2eeed-7780-40e7-83f9-998fe3e0b1a9 0363-1116 HUMAN OTC DRUG Scar with SPF 30 Walgreens Avobenzone - 3% Octocrylene - 10% Oxybenzone - 6% CREAM TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Walgreens AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 6 g/100g; g/100g; g/100g N 20181231 0363-1117_7a1c5377-e894-4e38-a088-aab3246b811a 0363-1117 HUMAN OTC DRUG Creal Zink Sunscreen SPF 50 Well at Walgreens Octinoxate 7.5% Octisalate 5.0% Zinc Oxide 14.5% STICK TOPICAL 20151207 OTC MONOGRAPH NOT FINAL part352 Walgreens OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 14.5 g/100g; g/100g; g/100g N 20181231 0363-1140_8fd575fd-bb2c-4c90-8c26-47fdba75b82f 0363-1140 HUMAN OTC DRUG Daytime Cold and Flu Non Drowsy acetaminophen, dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20170707 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0363-1141_2fe70f83-f0e6-3eb2-d615-3857c659d0a6 0363-1141 HUMAN OTC DRUG nighttime cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20170707 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 0363-1142_77ed7447-329e-268f-aa3e-0c13c8d18d35 0363-1142 HUMAN OTC DRUG Day Time Night Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20170710 OTC MONOGRAPH FINAL part341 Walgreens Company N 20181231 0363-1155_48c14005-811a-4868-b33e-934845504856 0363-1155 HUMAN OTC DRUG FAST ACTING Heartburn Relief aluminum hydroxide and magnesium carbonate TABLET, CHEWABLE ORAL 20180105 OTC MONOGRAPH FINAL part331 WALGREEN CO. ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 N 20181231 0363-1224_9090e2c0-4837-44ea-b6c4-f46532eadee1 0363-1224 HUMAN OTC DRUG Antacid Regular strength Antacid Tablets TABLET, CHEWABLE ORAL 20171218 OTC MONOGRAPH FINAL part331 WALGREEN CO. CALCIUM CARBONATE 500 mg/1 N 20181231 0363-1226_65ddd974-6706-44f5-980f-059c7f627183 0363-1226 HUMAN OTC DRUG Zinc oxide Zinc oxide CREAM TOPICAL 19940131 OTC MONOGRAPH FINAL part347 Walgreen Co ZINC OXIDE 130 mg/g N 20181231 0363-1234_41b98c0e-0d18-4fa0-a82c-ef7a60b53827 0363-1234 HUMAN OTC DRUG severe wal tussin cf max Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20171127 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 0363-1240_217d8a73-f598-80ff-06cf-33d0ca5f5454 0363-1240 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20170922 ANDA ANDA074612 Walgreens NICOTINE 7 mg/24h N 20191231 0363-1241_217d8a73-f598-80ff-06cf-33d0ca5f5454 0363-1241 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20170922 ANDA ANDA074612 Walgreens NICOTINE 14 mg/24h N 20191231 0363-1242_217d8a73-f598-80ff-06cf-33d0ca5f5454 0363-1242 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20170922 ANDA ANDA074612 Walgreens NICOTINE 21 mg/24h N 20191231 0363-1252_eea624a1-0d7e-486a-bccc-58c8c586df1a 0363-1252 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION ORAL 20100524 ANDA ANDA079058 Walgreen Company IBUPROFEN 50 mg/1.25mL N 20181231 0363-1255_3014d09a-9745-450a-a718-fff6b96839a0 0363-1255 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20100524 ANDA ANDA074916 Walgreen Company IBUPROFEN 100 mg/5mL N 20181231 0363-1261_3014d09a-9745-450a-a718-fff6b96839a0 0363-1261 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20100524 ANDA ANDA074916 Walgreen Company IBUPROFEN 100 mg/5mL N 20181231 0363-1262_3014d09a-9745-450a-a718-fff6b96839a0 0363-1262 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20100524 ANDA ANDA074916 Walgreen Company IBUPROFEN 100 mg/5mL N 20181231 0363-1263_3014d09a-9745-450a-a718-fff6b96839a0 0363-1263 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20100524 ANDA ANDA074916 Walgreen Company IBUPROFEN 100 mg/5mL N 20181231 0363-1298_837b0376-87d4-4e80-8080-8e964b81c67d 0363-1298 HUMAN OTC DRUG WALGREENS TOLNAFTATE TOLNAFTATE CREAM TOPICAL 20110504 OTC MONOGRAPH FINAL part333C WALGREEN COMPANY TOLNAFTATE 10 mg/g N 20181231 0363-1299_58ee4879-a368-4150-8133-757b1b334d79 0363-1299 HUMAN OTC DRUG WALGREENS CLOTRIMAZOLE CLOTRIMAZOLE CREAM TOPICAL 20110414 OTC MONOGRAPH FINAL part333C WALGREEN CO CLOTRIMAZOLE 1 g/100g N 20181231 0363-1352_1dac8435-8cce-4c74-a90d-85a14c70204e 0363-1352 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070910 ANDA ANDA078547 Walgreen Company NICOTINE 2 mg/1 N 20181231 0363-1397_fb9d45f2-ef59-4a25-a991-85d077726be4 0363-1397 HUMAN OTC DRUG childrens dye free pain and fever Acetaminophen SUSPENSION ORAL 20180104 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/5mL N 20191231 0363-1405_4d364e26-3326-428e-98a8-c7a1d38b2bcd 0363-1405 HUMAN OTC DRUG Walgreens Sinus Wash Squeeze Bottle Kit Sodium Chloride, Sodium Bicarbonate KIT 20170414 UNAPPROVED DRUG OTHER Walgreen Company N 20181231 0363-1406_4eaef9b5-3db8-4c91-91f2-feed56551f1a 0363-1406 HUMAN OTC DRUG Walgreens Filtered Squeeze Sinus Wash System Sodium Chloride, Sodium Bicarbonate KIT 20150701 UNAPPROVED DRUG OTHER Walgreen Company N 20181231 0363-1407_0bc6e356-38c9-492e-92ec-2eca43bdcc40 0363-1407 HUMAN OTC DRUG Wal-Dram 2 Quick-Dissolving meclizine hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20160301 OTC MONOGRAPH FINAL part336 Walgreen Co. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20191231 0363-1411_0ccf179f-e9a0-4f45-809b-bcd8dd955efa 0363-1411 HUMAN OTC DRUG WALGREENS ANTI ITCH DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part336 WALGREEN COMPANY DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1; .1 g/100g; g/100g E 20171231 0363-1419_0b10f190-0580-43de-a719-12eff5da169f 0363-1419 HUMAN OTC DRUG Lansoprazole Lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20170525 NDA NDA208025 Walgreen Company LANSOPRAZOLE 15 mg/1 N 20181231 0363-1465_48a1b268-700f-4955-90ba-d639248e801c 0363-1465 HUMAN OTC DRUG WALGREENS MAXIMUM REDNESS RELIEF GLYCERIN, NAPHAZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 WALGREEN COMPANY GLYCERIN; NAPHAZOLINE HYDROCHLORIDE .0025; .00012 mg/mL; mg/mL N 20181231 0363-1466_e0d7e2eb-b6f2-428d-965c-619363770ac3 0363-1466 HUMAN OTC DRUG WALGREENS LUBRICANT EYE CARBOXYMETHYLCELLULOSE SODIUM SOLUTION OPHTHALMIC 20120930 OTC MONOGRAPH FINAL part349 WALGREEN COMPANY CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 0363-1475_b199075b-d53f-4e4d-815d-0987e397af2c 0363-1475 HUMAN OTC DRUG childrens dye free wal zyr Cetirizine HCl SOLUTION ORAL 20171114 ANDA ANDA204226 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0363-1501_8bbd94ca-af29-49d3-93a0-720aa1af37ff 0363-1501 HUMAN OTC DRUG Childrens Ibuprofen 100 Ibuprofen SUSPENSION ORAL 20160908 ANDA ANDA074937 Walgreen Company IBUPROFEN 100 mg/5mL N 20181231 0363-1523_bc7f995d-5b7a-4d59-8d35-c045ed013bcb 0363-1523 HUMAN OTC DRUG childrens wal dryl pe diphenhydramine hcl, phenylephrine hcl SOLUTION ORAL 20171212 OTC MONOGRAPH FINAL part341 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/5mL; mg/5mL N 20181231 0363-1597_ae5a4587-cd23-4041-831b-efa77718945a 0363-1597 HUMAN OTC DRUG Severe Cold and Flu acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140908 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-1600_5c501fda-7e6e-4690-881e-1e6d35164999 0363-1600 HUMAN OTC DRUG Senna S docusate sodium and sennosides TABLET ORAL 20130330 OTC MONOGRAPH NOT FINAL part334 Walgreens SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 0363-1610_feaba764-4a21-473f-870f-e0e8fcfe13d0 0363-1610 HUMAN OTC DRUG IBUPROFEN IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20160127 ANDA ANDA079205 WALGREENS IBUPROFEN 200 mg/1 N 20181231 0363-1619_5fc2c3ed-f8c3-d28e-e053-2a91aa0ad8e0 0363-1619 HUMAN OTC DRUG MAXIMUM STRENGTH COMFORT GEL aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20140901 OTC MONOGRAPH FINAL part331 WALGREEN COMPANY ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 0363-1628_5fafd7d9-37bb-1b86-e053-2991aa0a341c 0363-1628 HUMAN OTC DRUG REGULAR STRENGTH COMFORT GEL aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20140801 OTC MONOGRAPH FINAL part331 WALGREEN COMPANY ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 0363-1639_5faf0ae4-01de-b8f1-e053-2a91aa0a2662 0363-1639 HUMAN OTC DRUG ADVANCED REGULAR STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20150101 OTC MONOGRAPH FINAL part331 WALGREEN COMPANY ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 0363-1640_865ae359-0d09-4095-8aa5-356e9dac3e84 0363-1640 HUMAN OTC DRUG Sore Throat Cherry Chloraseptic LIQUID ORAL 20120201 20181231 OTC MONOGRAPH NOT FINAL part356 Walgreens PHENOL 1.5 g/100mL N 20181231 0363-1648_5fae9b56-2556-b583-e053-2991aa0a8d59 0363-1648 HUMAN OTC DRUG MILK OF MAGNESIA CHERRY magnesium hydroxide LIQUID ORAL 20141201 OTC MONOGRAPH NOT FINAL part334 WALGREEN COMPANY MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0363-1650_40ec4900-4d2b-4dc3-9c1e-4989175280a3 0363-1650 HUMAN OTC DRUG Oral Relief Phenol SPRAY ORAL 20120201 OTC MONOGRAPH NOT FINAL part356 Walgreens PHENOL 1.4 g/100mL N 20181231 0363-1671_96019b76-0330-43eb-8b7f-bd97c5ebe619 0363-1671 HUMAN OTC DRUG Walgreens Sunscreen Sport SFP 70 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160309 OTC MONOGRAPH NOT FINAL part352 Walgreens Co. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-1676_4de572e9-1bc5-42d7-8490-aaf1992c8f3a 0363-1676 HUMAN OTC DRUG Walgreens Sterile Original Eye Drops Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20131002 OTC MONOGRAPH FINAL part349 Walgreens Company TETRAHYDROZOLINE HYDROCHLORIDE .05 mg/10mg N 20181231 0363-1677_9452d82d-433a-4f1d-8b97-b76ddc84b1aa 0363-1677 HUMAN OTC DRUG Walgreens Sterile Advance Relief Eye Drops Dextran, Polyethylene Glycol, Povidone, Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 Walgreen Company DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mg/mg; mg/mg; mg/mg; mg/mg N 20181231 0363-1678_2c376932-8f5d-4a7c-975f-e8df27c83423 0363-1678 HUMAN OTC DRUG Walgreens Artificial Tears Lubricant Eye Drops Dextran 70, Hypromellose 2910 SOLUTION/ DROPS OPHTHALMIC 20131002 OTC MONOGRAPH FINAL part349 Walgreens Company DEXTRAN 70; HYPROMELLOSES .001; .003 mg/mg; mg/mg N 20181231 0363-1686_d8984dcd-5750-4fa1-bcf9-58b729191335 0363-1686 HUMAN OTC DRUG WAL-ITIN LORATADINE CAPSULE, LIQUID FILLED ORAL 20161021 ANDA ANDA206214 WALGREENS LORATADINE 10 mg/1 N 20181231 0363-1701_142759ab-fbe0-4ea4-a9a7-a9ad66ead224 0363-1701 HUMAN OTC DRUG Walgreens Artificial Tears Lubricant Eye Drops Dextran 70, Hypromellose 2910 SOLUTION/ DROPS OPHTHALMIC 20131002 OTC MONOGRAPH FINAL part349 Walgreens Company DEXTRAN 70; HYPROMELLOSES .001; .003 mg/mg; mg/mg N 20181231 0363-1760_fe7cd15e-ddc1-4ec6-8db5-64b354e44e2f 0363-1760 HUMAN OTC DRUG Walgreens Maximum Strength Hemorrhoidal Glycerin, Phenylephrine HCL, Pramoxine HCL, and White petrolatum CREAM TOPICAL 20150225 OTC MONOGRAPH FINAL part346 Walgreen Company GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM .144; .0025; .01; .15 mg/g; mg/g; mg/g; mg/g N 20181231 0363-1761_0e836591-8b1c-493b-81ec-c9788a9e58de 0363-1761 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20180201 ANDA ANDA074916 Walgreen Company IBUPROFEN 100 mg/5mL N 20191231 0363-1764_0e836591-8b1c-493b-81ec-c9788a9e58de 0363-1764 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20160801 ANDA ANDA074916 Walgreen Company IBUPROFEN 100 mg/5mL N 20191231 0363-1791_504eacf9-629a-4a13-8552-98bf69f50508 0363-1791 HUMAN OTC DRUG Walgreens Lubricant Eye Carboxymethylcellulose sodium, and Glycerin SOLUTION/ DROPS OPHTHALMIC 20150727 OTC MONOGRAPH FINAL part349 Walgreen Company CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 0363-1792_8bd1896c-b0a0-410e-9d83-ac6a164e3550 0363-1792 HUMAN OTC DRUG Walgreens Lubricant Eye Carboxymethylcellulose sodium, and Glycerin SOLUTION/ DROPS OPHTHALMIC 20150727 OTC MONOGRAPH FINAL part349 Walgreen Company CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 0363-1857_e104441d-60d8-4c31-a304-e89f6e09affd 0363-1857 HUMAN OTC DRUG athletes foot Clotrimazole CREAM TOPICAL 20170929 OTC MONOGRAPH FINAL part333C Walgreen Company CLOTRIMAZOLE 1 g/100g N 20181231 0363-1898_f9b169b0-d378-4c3b-879b-c732f734a797 0363-1898 HUMAN OTC DRUG esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170922 ANDA ANDA207193 Walgreen Company ESOMEPRAZOLE 20 mg/1 N 20181231 0363-1973_ad56f22b-806b-4ee3-a575-6de3eec2e7a3 0363-1973 HUMAN OTC DRUG Hydrocortisone hydrocortisone CREAM TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g N 20191231 0363-1974_8f1a97de-31d4-4193-b61a-26680ee17b54 0363-1974 HUMAN OTC DRUG dye free wal zyr cetirizine hydrochloride SOLUTION ORAL 20171103 ANDA ANDA090254 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0363-2008_e9831cf9-73cb-475e-9a06-dc6c6b0eb5ce 0363-2008 HUMAN OTC DRUG Ology Fluoride Sodium Monofluorophosphate PASTE DENTAL 20130321 OTC MONOGRAPH FINAL part355 Walgreens SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 0363-2013_77b7d0ec-6698-40af-a247-5e5709f14eea 0363-2013 HUMAN OTC DRUG studio 35 beauty Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120601 OTC MONOGRAPH FINAL part350 WALGREEN COMPANY ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g E 20171231 0363-2014_306c7b87-35d0-40b6-a292-6a6604155f25 0363-2014 HUMAN OTC DRUG studio 35 beauty Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120610 OTC MONOGRAPH FINAL part350 WALGREEN COMPANY ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g E 20171231 0363-2016_e0f1960a-65e0-4b84-bac6-6497453090a0 0363-2016 HUMAN OTC DRUG Walgreens Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 0363-2062_5a804fa0-55dc-44df-a087-9e208f73acbc 0363-2062 HUMAN OTC DRUG Walgreens Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 Walgreen Company CLOTRIMAZOLE 2 g/100g N 20181231 0363-2063_37c6bc47-8c43-4389-8738-7604cf2e0990 0363-2063 HUMAN OTC DRUG Walgreens Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Walgreen Company HYDROCORTISONE 1 g/100g N 20181231 0363-2075_0a506bf7-143e-4b59-a5f1-b6d9f7e62ae2 0363-2075 HUMAN OTC DRUG Walgreens Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC 500 [USP'U]/g N 20181231 0363-2083_aab4fe7d-4fa1-4751-b681-3d041dc116ce 0363-2083 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Walgreen Company TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 0363-2085_baec871b-0e97-42ca-88c7-83220512f588 0363-2085 HUMAN OTC DRUG Wal-itin Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Walgreen Company LORATADINE 5 mg/5mL N 20181231 0363-2088_a63774ea-cae4-4c0f-b6d3-9824139359ec 0363-2088 HUMAN OTC DRUG Wal-Zyr Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0363-2092_a342cb25-d6e8-43ec-846f-a91c7fae3f99 0363-2092 HUMAN OTC DRUG Childrens Wal-itin Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Walgreen Company LORATADINE 5 mg/5mL N 20181231 0363-2100_9226e7dc-7881-4ce1-99d4-28c5a1019708 0363-2100 HUMAN OTC DRUG Athletes Foot Butenafine Hydrochloride CREAM TOPICAL 20171117 ANDA ANDA205181 Walgreen Company BUTENAFINE HYDROCHLORIDE 10 mg/g N 20181231 0363-2101_4c018fd2-bfdc-4f58-b62a-d4c39ce5d6fa 0363-2101 HUMAN OTC DRUG Jock Itch Butenafine Hydrochloride CREAM TOPICAL 20171117 ANDA ANDA205181 Walgreen Company BUTENAFINE HYDROCHLORIDE 10 mg/g N 20181231 0363-2102_8b75c8a9-7061-48ac-b18a-ab23371f7229 0363-2102 HUMAN OTC DRUG Wal-Zyr Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Walgreen Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0363-2103_6d6cecdc-646b-4c7b-b325-9423c29c57fc 0363-2103 HUMAN OTC DRUG Antacid Ultra Strength Assorted Fruits Antacid TABLET, CHEWABLE ORAL 20171218 OTC MONOGRAPH FINAL part331 WALGREEN CO. CALCIUM CARBONATE 1000 mg/1 N 20191231 0363-2103_e1b55f3a-c6d7-4374-acc7-134786a3765e 0363-2103 HUMAN OTC DRUG Antacid Ultra Strength Assorted Fruits Antacid TABLET, CHEWABLE ORAL 20171218 OTC MONOGRAPH FINAL part331 WALGREEN CO. CALCIUM CARBONATE 1000 mg/1 N 20191231 0363-2106_1e8ecd9d-ca6c-40aa-9864-b9deb6eb2e9f 0363-2106 HUMAN OTC DRUG Wal-Zyr All Day Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 WALGREEN COMPANY CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 0363-2108_8821c758-7315-4c7c-9459-dd0944b07087 0363-2108 HUMAN OTC DRUG Childrens Walitin Loratadine SOLUTION ORAL 20161212 ANDA ANDA201865 Walgreen Company LORATADINE 5 mg/5mL N 20181231 0363-2109_6cf099cc-ebff-439f-9735-8b7bca42b180 0363-2109 HUMAN OTC DRUG Walgreens Jock Itch Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Walgreen Company CLOTRIMAZOLE 10 mg/g N 20181231 0363-2131_d2c41f27-4d63-41c6-a6d7-25e5a31a4f90 0363-2131 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Walgreen Company LORATADINE 5 mg/5mL N 20191231 0363-2171_34d4bf20-0e9b-4651-a376-b772c1801c12 0363-2171 HUMAN OTC DRUG Patch Walgreens Menthol PATCH TOPICAL 20140808 OTC MONOGRAPH NOT FINAL part348 Walgreens MENTHOL 775 mg/1 N 20181231 0363-2172_1cdbe069-d1c6-4477-a7eb-3a2c7d4ec4e1 0363-2172 HUMAN OTC DRUG Patch Walgreens Menthol PATCH TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part348 Walgreens MENTHOL 775 mg/1 N 20181231 0363-2173_7ebdff37-4477-4c29-86c7-b88f87760586 0363-2173 HUMAN OTC DRUG Solution Minoxidil SOLUTION TOPICAL 20140808 ANDA ANDA078176 Walgreens MINOXIDIL .02 g/mL N 20181231 0363-2173_edbb3c3a-afb9-480b-9ee6-36cc53edd875 0363-2173 HUMAN OTC DRUG Solution Minoxidil SOLUTION TOPICAL 20140808 ANDA ANDA078176 Walgreens MINOXIDIL .02 g/mL N 20181231 0363-2174_b9625aab-4b2f-4bd0-8232-3600061c5f66 0363-2174 HUMAN OTC DRUG Patch Walgreens Menthol PATCH TOPICAL 20140808 OTC MONOGRAPH NOT FINAL part348 Walgreens MENTHOL 1.22 g/1 N 20181231 0363-2175_50e5d355-8145-4275-9d23-1d0688d6ef26 0363-2175 HUMAN OTC DRUG Patch Walgreens Menthol PATCH TOPICAL 20140808 OTC MONOGRAPH NOT FINAL part348 Walgreens MENTHOL .75 g/1 N 20181231 0363-2176_80875d91-e162-4ec0-b51a-8b3e23c9a032 0363-2176 HUMAN OTC DRUG Patch Walgreens Menthol PATCH TOPICAL 20140808 OTC MONOGRAPH NOT FINAL part348 Walgreens MENTHOL 350 mg/1 N 20181231 0363-2177_a1e67d9e-e1a2-45de-bc3b-712b3f82ea2d 0363-2177 HUMAN OTC DRUG EXTRA STRENGTH WAL-DRYL ITCH RELIEF DIPHENHYDRAMINE, ZINC ACETATE SPRAY TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part348 WALGREEN CO DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 mL/100mL; mL/100mL N 20181231 0363-2242_889cb90f-a486-4760-881d-e517be63658a 0363-2242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part347 Walgreens DIMETHICONE 125 mg/1 N 20181231 0363-2309_59afdc0a-5e45-4cca-abef-4415c170a19a 0363-2309 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20180104 ANDA ANDA206393 Walgreen Company NICOTINE 4 mg/1 N 20191231 0363-2390_0635758e-447f-4605-9868-0951c22b6298 0363-2390 HUMAN OTC DRUG Wal-itin D 24 Hour Loratadine and Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20160301 ANDA ANDA075706 Walgreen Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 0363-2529_74ac83c5-db2e-485f-8fe4-0c29f94e1006 0363-2529 HUMAN OTC DRUG Bronchial Asthma Relief Ephedrine HCl, Guaifenesin TABLET ORAL 20020213 OTC MONOGRAPH FINAL part341 Walgreens Company GUAIFENESIN; EPHEDRINE HYDROCHLORIDE 200; 12.5 mg/1; mg/1 N 20181231 0363-2720_4ee95565-6a1f-4c1b-a0ed-386f589e4ae7 0363-2720 HUMAN OTC DRUG Walgreen Sport SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160309 OTC MONOGRAPH NOT FINAL part352 Walgreens Co. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-2990_278c2b13-8bde-40b2-b53c-a879472862d3 0363-2990 HUMAN OTC DRUG Dye-Free Wal-Dryl Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20010913 20180727 OTC MONOGRAPH FINAL part336 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 0363-3000_aac1f826-be56-4784-91e2-d540f8fdb07d 0363-3000 HUMAN OTC DRUG Wal-Sporin Bacitracin Zinc, Polymyxin B Sulfate OINTMENT TOPICAL 20061030 20180331 OTC MONOGRAPH FINAL part333B Walgreen Company BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 0363-3001_89b02b2b-1a77-4e9d-a939-a88a494b954e 0363-3001 HUMAN OTC DRUG Pain and Itch Relief 4% Lidocaine Lidocaine CREAM TOPICAL 20160115 OTC MONOGRAPH NOT FINAL part348 Walgreens LIDOCAINE .04 g/40g N 20181231 0363-3010_601820b2-1d00-988f-e053-2a91aa0ae9bd 0363-3010 HUMAN OTC DRUG SENNA-S DOCUSATE SODIUM and SENNOSIDES CAPSULE, GELATIN COATED ORAL 20160301 OTC MONOGRAPH NOT FINAL part334 Walgreens DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 0363-3011_6018b898-2de2-51b6-e053-2a91aa0a43eb 0363-3011 HUMAN OTC DRUG WOMENS GENTLE LAXATIVE BISACODYL CAPSULE, GELATIN COATED ORAL 20160301 OTC MONOGRAPH NOT FINAL part334 Walgreens BISACODYL 5 mg/1 N 20181231 0363-3019_0f75c10a-de71-422b-9f50-0d622ed366bc 0363-3019 HUMAN OTC DRUG EAR DRY DROPS WELL AT WALGREENS ISOPROPYL ALCOHOL 94.998% GLYCERIN 5% LIQUID AURICULAR (OTIC) 20130415 OTC MONOGRAPH FINAL part344 Walgreens ISOPROPYL ALCOHOL 94.998 1/100mL N 20191231 0363-3063_deea44c1-6e4e-4d11-9e8d-e628e3a70702 0363-3063 HUMAN OTC DRUG Walgreens Corn Remover SALICYLIC ACID STRIP TOPICAL 20130601 OTC MONOGRAPH FINAL part358F WALGREENS Co SALICYLIC ACID 4.42 mg/1 N 20181231 0363-3102_ab7e58f4-ba7e-4a1f-9b0c-4789587d06c5 0363-3102 HUMAN OTC DRUG Dry Skin Treatment Studio 35 PETROLATUM 41% OINTMENT TOPICAL 20130215 OTC MONOGRAPH FINAL part347 Walgreens PETROLATUM 41 g/100g N 20181231 0363-3103_ae2cd8fb-73e2-43f4-8aa9-f92b06e21a6d 0363-3103 HUMAN OTC DRUG Antacid Extra Strength Wintergreen Antacid TABLET, CHEWABLE ORAL 20171219 OTC MONOGRAPH FINAL part331 WALGREEN CO. CALCIUM CARBONATE 750 mg/1 N 20191231 0363-3104_3f0006d5-e548-44df-a5a3-ccda6ac806f7 0363-3104 HUMAN OTC DRUG First Aid Antiseptic Well at Walgreens Benzocaine 20.00% Triclosan 0.13% SPRAY TOPICAL 20140215 OTC MONOGRAPH NOT FINAL part348 Walgreens BENZOCAINE; TRICLOSAN 200; 1.3 mg/mL; mg/mL N 20181231 0363-3106_27cba97c-091a-4c10-b940-20f27b19e6a6 0363-3106 HUMAN OTC DRUG Cooling Itch Relief Well at Walgreens Hydrocortisone 1% SPRAY TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Walgreens HYDROCORTISONE 1 g/100g N 20181231 0363-3107_58655bec-e62f-4387-9f24-ef1127fb2506 0363-3107 HUMAN OTC DRUG Burn Relief Pain Reliever Well at Walgreens Lidocaine 0.5% SPRAY TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Walgreens LIDOCAINE .5 g/100g N 20191231 0363-3111_e87d64d9-5fa5-4407-808e-87f6f583aac3 0363-3111 HUMAN OTC DRUG Sheer SPF 30 Oil Free Well at Walgreens Avobenzone 2.00% Homosalate 15.00% Octinoxate 7.50% Octisalate 5.00% STICK TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part352 Walgreens AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 2; 15; 7.5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 0363-3112_cbac2699-6fad-4539-86ef-45d8ac9bc4bd 0363-3112 HUMAN OTC DRUG SHEER SPF 55 Well at Walgreens Avobenzone - 3.00% Homosalate - 10.00% Octisalate - 5.00% Octocrylene - 2.75% Oxybenzone - 6.00% LOTION TOPICAL 20120715 OTC MONOGRAPH NOT FINAL part352 Walgreens AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.75; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 0363-3113_09ef90c3-1fc3-48be-8071-2fa387a46175 0363-3113 HUMAN OTC DRUG Antacid Ultra Strength Antacid TABLET, CHEWABLE ORAL 20171218 OTC MONOGRAPH FINAL part331 WALGREEN CO. CALCIUM CARBONATE 1000 mg/1 N 20191231 0363-3181_1def6076-5f1a-45d3-a78f-c783f25f4120 0363-3181 HUMAN OTC DRUG Foaming Acne Face Wash Walgreens Benzoyl Peroxide 10% CREAM TOPICAL 20130215 OTC MONOGRAPH FINAL part333D Walgreens BENZOYL PEROXIDE 10 g/100g N 20181231 0363-3186_ba531ef6-e3bb-462c-8ed3-629ba4a0de67 0363-3186 HUMAN OTC DRUG First Aid Antiseptic Well at Walgreens Benzalkonium 0.13%, Lidocaine HCI 2.5% SPRAY TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Walgreens LIDOCAINE HYDROCHLORIDE; BENZALKONIUM 25; .13 mg/mL; g/mL N 20181231 0363-3187_70676bf3-5d2b-4f2b-b6a3-a46255d66817 0363-3187 HUMAN OTC DRUG ARTHRITIS RELIEF WELL AT WALGREENS Trolamine Salicylate 10% SPRAY TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part348 Walgreens TROLAMINE SALICYLATE 100 mg/mL N 20181231 0363-3189_a7d7cdba-5c44-4670-bcc1-f2fd06e6abe0 0363-3189 HUMAN OTC DRUG Pain Relief Well At Walgreens Camphor 4%, Menthol 10%, Methyl Salicylate 30% SPRAY TOPICAL 20121215 OTC MONOGRAPH NOT FINAL part348 Walgreens CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g N 20181231 0363-3190_c29aab50-3d8d-4c86-af18-1b8282b1bc7c 0363-3190 HUMAN OTC DRUG Bite and Sting Relief Well at Walgreens Benzocaine - 5.00% SPRAY TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Walgreens BENZOCAINE 5 g/100g N 20191231 0363-3191_67d18f83-eb96-42ae-90f4-883f3bca0b77 0363-3191 HUMAN OTC DRUG Walgreens Cold Sore Treatment Benzocaine OINTMENT TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part348 Walgreens BENZOCAINE 5 mg/g N 20181231 0363-3192_4b5bb081-427e-44a1-bf5e-204f4acf6cf1 0363-3192 HUMAN OTC DRUG Aloe Gel Pain Reliever Well at Walgreens Lidocaine Hydrochloride 0.5% GEL TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Walgreens LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 0363-3195_f9333252-fc0d-489f-bedd-ffdb176344cb 0363-3195 HUMAN OTC DRUG Capsaicin No-Fuss Applicator Capsaicin 0.15% LIQUID TOPICAL 20140515 OTC MONOGRAPH NOT FINAL part348 Walgreens CAPSAICIN 1.5 mg/mL N 20181231 0363-3203_2ae0d4bd-25b0-497e-93dd-496bc97eb945 0363-3203 HUMAN OTC DRUG Daily Moisturizing Well at Walgreens Colloidal Oatmeal 1% CREAM TOPICAL 20130315 OTC MONOGRAPH FINAL part347 Walgreens OATMEAL 1 g/100g N 20181231 0363-3206_cbb90301-bcb7-4920-9c93-1610bfbe06b7 0363-3206 HUMAN OTC DRUG Hemorrhoidal Soothing Well at Walgreens Phenylephrine HCl - .25% Witch Hazel Extract - 50.0% SPRAY TOPICAL 20120415 OTC MONOGRAPH FINAL part346 Walgreens PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 25; 50 g/100g; g/100g N 20181231 0363-3207_6deeff47-5aca-4465-955c-94e8e7355fd1 0363-3207 HUMAN OTC DRUG Cool n Heat Well at Walgreens Menthol 16% SPRAY TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Walgreens MENTHOL 160 mg/mL N 20181231 0363-3211_7bb9398a-d6ed-4435-8ca6-61ce7ce3545e 0363-3211 HUMAN OTC DRUG Invisible Acne Well at Walgreens Benzoyl Peroxide 10% CREAM TOPICAL 20130215 OTC MONOGRAPH FINAL part333D Walgreens BENZOYL PEROXIDE 10 g/100g N 20181231 0363-3212_a6b547fb-b7ba-443c-98d1-810a69504a04 0363-3212 HUMAN OTC DRUG 70% Isopropyl Alcohol Well at Walgreens Isopropyl Alcohol 70.0% SPRAY TOPICAL 20140215 OTC MONOGRAPH NOT FINAL part333A Walgreens ISOPROPYL ALCOHOL 700 mg/mL N 20181231 0363-3215_37f3ce94-9230-40bb-927e-b817bd5572f9 0363-3215 HUMAN OTC DRUG SPF 55 Sport Sunstick Well at Walgreens Avobenzone - 3.0% Homosalate - 15.0% Octisalate - 5.0% Octocrylene - 10.0% Oxybenzone - 6.0% STICK TOPICAL 20140215 OTC MONOGRAPH NOT FINAL part352 Walgreens AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 3; 15; 10; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-3216_1338b60a-1523-4d9e-bdf8-c0937f54dacc 0363-3216 HUMAN OTC DRUG Baby SPF 60 Sunscreen Titanium Dioxide - 6.00% Zinc Oxide - 4.70% STICK TOPICAL 20130213 OTC MONOGRAPH NOT FINAL part352 Walgreens TITANIUM DIOXIDE; ZINC OXIDE 6; 4.7 g/100g; g/100g N 20181231 0363-3222_bcb8da06-7ad0-4638-8674-f5b6f4b8a236 0363-3222 HUMAN OTC DRUG Sheer SPF 100 Well at Walgreens Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 10.00% Oxybenzone 6.00% LOTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 Walgreens AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 0363-3223_e786ad27-b922-47f0-aec6-50a65648d8b3 0363-3223 HUMAN OTC DRUG WELL AT WALG TRIPLE ANTIBIOTIC Well at Walgreens Bacitracin, Neomycin, Polymyxin B OINTMENT TOPICAL 20130315 OTC MONOGRAPH FINAL part333B Walgreens BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 0363-3225_e08ff122-53d0-4ef4-a5c2-7304640a2f6a 0363-3225 HUMAN OTC DRUG Sheer SPF 30 Well at Walgreens Avobenzone - 3.00% Homosalate - 8.00% Octisalate - 5.00% Octocrylene - 4.00% Oxybenzone - 4.00% LOTION TOPICAL 20140215 OTC MONOGRAPH NOT FINAL part352 Walgreens AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 8; 5; 4; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 0363-3226_ff056581-b082-409c-ab24-f20e87103d01 0363-3226 HUMAN OTC DRUG 3 Step Acne System Well at Walgreens Benzoyl Peroxide KIT 20140715 OTC MONOGRAPH FINAL part333D Walgreens N 20181231 0363-3229_44e4866d-202b-4152-afec-abd672a8a408 0363-3229 HUMAN OTC DRUG Ear Wax Kit Well at Walgreens Carbamide Peroxide - 6.50% KIT 20140815 OTC MONOGRAPH FINAL part344 Walgreens N 20181231 0363-3231_0b4937bf-c7a3-4bb1-99ef-7eb87f4515ee 0363-3231 HUMAN OTC DRUG MEDICATED ANTI-ITCH Well at Walgreens Menthol 1 % Pramoxine Hydrochloride 1 % CREAM TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part348 Walgreens MENTHOL; PRAMOXINE HYDROCHLORIDE 1; 1 g/100g; g/100g N 20181231 0363-3242_a3d7b30f-ec33-4395-b050-557de7a879ce 0363-3242 HUMAN OTC DRUG 3% Hydrogen Peroxide Well at Walgreens Hydrogen Peroxide - 3.00% SPRAY TOPICAL 20140215 OTC MONOGRAPH NOT FINAL part333A Walgreens HYDROGEN PEROXIDE 3 g/100mL N 20181231 0363-3267_073e9e28-8ec0-4be2-a5bb-19c0e131c404 0363-3267 HUMAN OTC DRUG No Touch Application Chest Rub Well at Walgreens Camphor 4.80% Eucalyptus Oil 1.20% Menthol 2.60% STICK TOPICAL 20150915 OTC MONOGRAPH FINAL part341 Walgreens CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g N 20181231 0363-3278_913cfb74-08df-4d5c-a27d-79f7e3ad62ed 0363-3278 HUMAN OTC DRUG Pain Relief Well at Walgreens Lidocaine HCl 4% CREAM TOPICAL 20150730 OTC MONOGRAPH NOT FINAL part348 Walgreens LIDOCAINE 4 g/100g N 20181231 0363-3300_60c2a683-4cec-4304-b5eb-a1d0dff9dd22 0363-3300 HUMAN OTC DRUG WELL AT WALGREENS BABY ADVANCED HEALING PETROLATUM LOTION TOPICAL 20140806 OTC MONOGRAPH FINAL part346 WALGREEN COMPANY PETROLATUM .41 g/g N 20181231 0363-3350_80bdf080-b30e-4a78-9869-19ce0b966ed1 0363-3350 HUMAN OTC DRUG Mucus Relief Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 0363-3355_14baa410-6ce3-4ddb-aac7-e2172d1506c4 0363-3355 HUMAN OTC DRUG Antacid Extra Strength Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20171219 OTC MONOGRAPH FINAL part331 WALGREEN CO. CALCIUM CARBONATE 750 mg/1 N 20181231 0363-3360_c066f3dd-4d7c-4388-a1f9-837d03f47b74 0363-3360 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Walgreens DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 650; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 0363-3380_410e1999-f5c8-473a-95b8-e574e6f4e1d8 0363-3380 HUMAN OTC DRUG Mucus Relief DM Max Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Walgreens DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 0363-3390_aa797e94-6560-41c9-8c71-458a1086e841 0363-3390 HUMAN OTC DRUG Antacid Extra Strength Antacid TABLET, CHEWABLE ORAL 20171218 OTC MONOGRAPH FINAL part331 WALGREEN CO. CALCIUM CARBONATE 750 mg/1 N 20191231 0363-3400_8b15bfff-e22a-4b48-9ccf-77fe380a67c7 0363-3400 HUMAN OTC DRUG Well at Walgreens Ultimate Daily SALICYLIC ACID GEL TOPICAL 20151101 OTC MONOGRAPH FINAL part333D Walgreen Company SALICYLIC ACID 4 g/200g N 20181231 0363-3420_8ea5f196-8c1b-43ba-98c0-b23e18ee3ebc 0363-3420 HUMAN OTC DRUG Maximum Strength Allergy Sinus Acetaminophen, Chlorpheniramine maleate, Pseudoephedrine HCl TABLET ORAL 19991001 20180610 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 500; 2; 30 mg/1; mg/1; mg/1 E 20171231 0363-3440_8ad7ab68-789c-4b33-92ad-7c55b0fe7a28 0363-3440 HUMAN OTC DRUG Awake Maximum Strength Caffeine TABLET, FILM COATED ORAL 19980414 OTC MONOGRAPH FINAL part340 Walgreen Company CAFFEINE 200 mg/1 N 20181231 0363-3492_60680a20-4c23-5d5a-e053-2a91aa0a8e57 0363-3492 HUMAN OTC DRUG Clotrimazole Clotrimazole LIQUID TOPICAL 20151101 OTC MONOGRAPH FINAL part333C Walgreens CLOTRIMAZOLE 1 mg/mL N 20181231 0363-3510_6d9e6b05-a2a7-4ff6-ae7a-df1b5fc11603 0363-3510 HUMAN OTC DRUG Jock Itch Clotrimazole CREAM TOPICAL 20140615 OTC MONOGRAPH FINAL part333C Walgreen Company CLOTRIMAZOLE 1 g/100g N 20181231 0363-3550_7e98794d-170f-400a-acb7-8c9ab35c8e77 0363-3550 HUMAN OTC DRUG Walgreens Baby Eczema Colloidal Oatmeal CREAM TOPICAL 20171128 OTC MONOGRAPH FINAL part347 Walgreen Company OATMEAL .01 g/g N 20181231 0363-3560_6abadab3-868b-43eb-968d-f0b2eea9ba10 0363-3560 HUMAN OTC DRUG OLOGY TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130405 OTC MONOGRAPH FINAL part346 WALGREEN COMPANY TITANIUM DIOXIDE; ZINC OXIDE .0255; .03 g/g; g/g N 20181231 0363-3680_6043a2a4-e76c-290e-e053-2a91aa0ae99c 0363-3680 HUMAN OTC DRUG Walgreens Moisture Barrier Menthol, and Zinc Oxide CREAM TOPICAL 20150216 OTC MONOGRAPH FINAL part347 Walgreen Company MENTHOL; ZINC OXIDE .44; 20.6 g/100g; g/100g N 20181231 0363-3701_16d34649-6a4b-40d0-a2e0-924fdd02ccb3 0363-3701 HUMAN OTC DRUG STUDIO 35 SPRING MORNING TRICLOSAN LIQUID TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part333E WALGREEN COMPANY TRICLOSAN 1.5 mg/mL N 20181231 0363-3780_514ecac4-0786-470e-a4ac-c085c0c8cd27 0363-3780 HUMAN OTC DRUG Triacting Daytime Cold Cough Childrens Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Walgreens DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 0363-3790_2aaaf01c-9f4d-43e1-b9eb-97230a342a68 0363-3790 HUMAN OTC DRUG Childrens Cold and Cough Nighttime Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Walgreens DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 0363-3890_293e408f-37f0-4e32-8f69-a3805dea0e0b 0363-3890 HUMAN OTC DRUG Walgreens Sport Faces SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160608 OTC MONOGRAPH NOT FINAL part352 Walgreen Co. AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 2; 13; 1; 5; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-4000_a58a8ff3-1b5c-4c7e-8d94-1765d1d7fbd7 0363-4000 HUMAN OTC DRUG Walgreens Aloe Vera Burn Relief Pain Relieving LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part348 WALGREEN CO. LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 0363-4001_091e79d0-193a-45ca-9511-261bcaf91747 0363-4001 HUMAN OTC DRUG Walgreens Sunscreen SPF 15 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g N 20181231 0363-4002_741b4923-11ec-407d-8142-6aafffa78062 0363-4002 HUMAN OTC DRUG Walgreens Aloe Vera Cooling MENTHOL GEL TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part348 WALGREEN CO. MENTHOL .1 g/100g N 20181231 0363-4003_aac95c08-2eaf-4e50-afd6-c80eae677a96 0363-4003 HUMAN OTC DRUG Walgreens Aloe Vera Pain Relieving LIDOCAINE GEL TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part348 WALGREEN CO. LIDOCAINE; MENTHOL .5; .1 g/100g; g/100g N 20181231 0363-4004_0b8329b9-858e-4641-94f5-6fd11f5960ce 0363-4004 HUMAN OTC DRUG Walgreens Dark Tanning Oil Sunscreen SPF 4 OCTINOXATE SPRAY TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. OCTINOXATE 3 g/100g N 20181231 0363-4005_3494c44d-6001-408f-9bb0-308a35332b04 0363-4005 HUMAN OTC DRUG Walgreens Sunscreen Sport SPF 30 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-4006_696cda86-c6fd-44a7-8a08-bed5ef62c2c3 0363-4006 HUMAN OTC DRUG Walgreens Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-4007_fa5c64c2-3a67-4aa7-baa1-e9595c618851 0363-4007 HUMAN OTC DRUG Walgreens Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20161019 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-4008_ae78166e-77e9-4ada-b0b9-e0594f381e86 0363-4008 HUMAN OTC DRUG Walgreens SunscreenSPF 45 SPF 45 SPF 45 ZINC OXIDE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. OCTOCRYLENE; ZINC OXIDE; OCTINOXATE 8; 6.86; 7.5 g/100g; g/100g; g/100g N 20181231 0363-4009_bcb9a966-3572-4bc2-be16-43fbab91bdf9 0363-4009 HUMAN OTC DRUG Walgreens SunscreenSPF 70 SPF 70 OCTOCRYLENE OXYBENZONE ZINC OXIDE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 2; 3.9 g/100g; g/100g; g/100g N 20181231 0363-4010_30561192-5799-4c88-99b1-c521a36f9c76 0363-4010 HUMAN OTC DRUG Walgreens Sunscreen Baby SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 13; 4; 3; 5; 7 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-4011_90c559f2-e631-4748-a03e-fe67c1c55074 0363-4011 HUMAN OTC DRUG Walgreens Sunscreen Sport SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-4012_18354cb3-68f5-41d5-8a21-c8d7b48463cd 0363-4012 HUMAN OTC DRUG Walgreens PAIN RELIEVING LIDOCAINE MENTHOL GEL TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part348 WALGREEN CO. LIDOCAINE; MENTHOL .7; .2 g/100g; g/100g N 20181231 0363-4013_15ef02f7-b372-49b5-8227-70059fa0f7ce 0363-4013 HUMAN OTC DRUG Walgreens sunscreen Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 0363-4014_e58a0c7d-887a-4a2f-b3cd-a59ab469a1f9 0363-4014 HUMAN OTC DRUG Walgreens SUNSCREEN Clear Zinc Broad Spectrum SPF 50 OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. OCTOCRYLENE; ZINC OXIDE 4; 5 g/100g; g/100g N 20181231 0363-4015_f698b299-fe2a-4ba4-9b16-344119596651 0363-4015 HUMAN OTC DRUG Walgreens SUNSCREEN Sport Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-4016_f476603b-2600-430e-8f21-50da8c4dc45a 0363-4016 HUMAN OTC DRUG Walgreens Sunscreen Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE LOTION TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 WALGREEN CO. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g N 20181231 0363-4017_70c7a2f7-254f-4ab6-867b-f3a34e9cc333 0363-4017 HUMAN OTC DRUG WALGREENS CLEAR FACE Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160308 OTC MONOGRAPH NOT FINAL part352 Walgreens AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-4018_0d1e4329-5cca-41f2-9dab-887813bd29df 0363-4018 HUMAN OTC DRUG WALGREENS KIDS SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160308 OTC MONOGRAPH NOT FINAL part352 Walgreens AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-4050_31b709c4-9a86-4e77-8224-2fc031d060e8 0363-4050 HUMAN OTC DRUG Cough Cold and Sore Throat Childrens Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL N 20181231 0363-4115_60a73d51-761b-e8c1-e053-2991aa0a4780 0363-4115 HUMAN OTC DRUG Walgreens Original Strength Anti Itch Diphenhydramine hydrochloride, zinc acetate CREAM TOPICAL 20130927 OTC MONOGRAPH NOT FINAL part348 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1; .1 g/100g; g/100g N 20191231 0363-4120_6155df96-1438-4dda-b870-3e8f01f8af7b 0363-4120 HUMAN OTC DRUG Pressure plus Pain plus Mucus Non-Drowsy Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 0363-4190_e4c706f9-934c-401c-8efd-ac6211aaa555 0363-4190 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20141105 ANDA ANDA090711 Walgreen Company NICOTINE 4 mg/1 N 20181231 0363-4193_e944c765-67f0-4b96-8640-2f8feb9d8442 0363-4193 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20141001 OTC MONOGRAPH NOT FINAL part334 Walgreen Company MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0363-4200_4d13cab4-35ac-4407-8138-7bdd96344c84 0363-4200 HUMAN OTC DRUG Daytime Nighttime Multi Symptom Cold Childrens Dextromethorphan HBr,Guaifenesin,Phenylephrine HCl,Acetaminophen,Diphenhydramine HCl, Phenylephrine HCl KIT 20141231 OTC MONOGRAPH FINAL part341 Walgreens N 20181231 0363-4208_ddb3c5dd-c9e8-4805-8bd9-6b573ab8c812 0363-4208 HUMAN OTC DRUG Miconazole Nitrate Athletes Foot Liquid SPRAY TOPICAL 20100518 OTC MONOGRAPH FINAL part333C Walgreens Company MICONAZOLE NITRATE 3 g/150g N 20181231 0363-4246_8e5348a2-2289-4fb3-8073-c580c7a15236 0363-4246 HUMAN OTC DRUG studio35 Eczema Colloidal Oatmeal CREAM TOPICAL 20140901 OTC MONOGRAPH FINAL part347 Walgreen Company OATMEAL 1 g/100g N 20181231 0363-4360_b3a5a1d0-4012-436c-8e0c-99bee5cd0229 0363-4360 HUMAN OTC DRUG Walgreens Calamine Skin Protectant FERRIC OXIDE RED, ZINC OXIDE LOTION TOPICAL 20111005 OTC MONOGRAPH FINAL part347 Walgreen Company FERRIC OXIDE RED; ZINC OXIDE 8; 8 mL/100mL; mL/100mL N 20181231 0363-4380_42af188b-c4b7-4d43-bf6b-8591205c7c73 0363-4380 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Walgreen Company IBUPROFEN 200 mg/1 N 20181231 0363-4404_c0e57d7e-4953-48f1-a08d-aaca192c23b2 0363-4404 HUMAN OTC DRUG Walgreens Antibacterial Plus Urinary Pain Relief METHENAMINE, SODIUM SALICYLATE TABLET ORAL 20170222 UNAPPROVED DRUG OTHER Walgreen Company METHENAMINE; SODIUM SALICYLATE 162; 162.5 mg/1; mg/1 N 20191231 0363-4429_580f8fef-cda6-4d3b-80a0-134d5a184b5c 0363-4429 HUMAN OTC DRUG Well Beginnings Baby Eczema Colloidal Oatmeal CREAM TOPICAL 20140415 OTC MONOGRAPH FINAL part347 Walgreen Company OATMEAL 1 g/100g N 20181231 0363-4470_a1e0dbbe-517f-42be-b833-a6db338ce652 0363-4470 HUMAN OTC DRUG Pain Reliever PM Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20141230 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0363-4490_30afa0d4-2987-4bbc-b55d-3e0225985aa7 0363-4490 HUMAN OTC DRUG Junior Pain and Fever Fast Dissolving Acetaminophen TABLET, CHEWABLE ORAL 20050128 20190727 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/1 N 20181231 0363-4500_5387cfa2-6b72-4a06-84c0-f28f5f2ecd34 0363-4500 HUMAN OTC DRUG Pain and Fever Junior Acetaminophen TABLET ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/1 N 20181231 0363-4501_93b37b21-7524-4cde-9e11-19d9be24dfa8 0363-4501 HUMAN OTC DRUG Pain and Fever Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/1 N 20181231 0363-4554_9534e6c0-aef5-46fb-a76f-d102159a4825 0363-4554 HUMAN OTC DRUG Sinus Congestion and Pain Daytime/Nighttime Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl KIT 20050726 20190808 OTC MONOGRAPH FINAL part341 Walgreen Company E 20171231 0363-4660_ecc8efc3-4378-4a50-a49b-d289237787ff 0363-4660 HUMAN OTC DRUG Oil-Free Daily Face Salicylic Acid CREAM TOPICAL 20140915 OTC MONOGRAPH FINAL part333D Walgreen Company SALICYLIC ACID 2 g/100g N 20181231 0363-4663_5ef9364d-560c-6c88-e053-2a91aa0a1337 0363-4663 HUMAN OTC DRUG Salicylic Acid Wart Remover Gel Pen GEL TOPICAL 20140315 OTC MONOGRAPH FINAL part358B Walgreens Company SALICYLIC ACID .17 g/g N 20181231 0363-4730_71c9dafa-3e6b-4653-b0f3-1180538a9f6c 0363-4730 HUMAN OTC DRUG Nighttime Multi-Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl CAPSULE ORAL 20050721 20181105 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 0363-4734_5082092f-4c5d-4566-a85f-20e2f40fdd32 0363-4734 HUMAN OTC DRUG Walgreens Sport SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20160105 OTC MONOGRAPH NOT FINAL part352 Walgreens AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-4735_3cf982e2-4f3e-4414-8c1f-39fbd0415b0b 0363-4735 HUMAN OTC DRUG Walgreens Zinc SPF 50 OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20160106 OTC MONOGRAPH NOT FINAL part352 Walgreens OCTOCRYLENE; ZINC OXIDE 4; 5 g/100g; g/100g N 20181231 0363-4809_60563246-98c8-8a96-e053-2a91aa0a4ec7 0363-4809 HUMAN OTC DRUG Walgreen Sterile Lubricant Drops 70 Count Carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20140325 OTC MONOGRAPH FINAL part349 Walgreen Company CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 0363-4816_60560818-fda8-aaad-e053-2991aa0ac710 0363-4816 HUMAN OTC DRUG Walgreen Sterile Lubricant Drops 30 Count Carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20140325 OTC MONOGRAPH FINAL part349 Walgreen Company CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 0363-4850_9e1962b8-caaa-46e8-9ae9-e45e5e6e1d37 0363-4850 HUMAN OTC DRUG Wal-Dryl PE Allergy and Sinus Diphenhydramine HCl, Phenylephrine HCl TABLET, FILM COATED ORAL 20050810 OTC MONOGRAPH FINAL part341 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 25; 10 mg/1; mg/1 N 20181231 0363-4980_5089dace-7da9-4b0a-9bb7-18fb0d82a551 0363-4980 HUMAN OTC DRUG Walgreens Sport SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20160106 OTC MONOGRAPH NOT FINAL part352 Walgreens AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-5000_27573e3c-cf64-4bb7-be67-5181f1412d91 0363-5000 HUMAN OTC DRUG Chocolated Laxative Sennosides Stimulant Laxative TABLET, CHEWABLE ORAL 20140410 OTC MONOGRAPH NOT FINAL part334 Walgreens SENNOSIDES 15 mg/1 E 20171231 0363-5010_2f2b0dfa-5115-3e9f-cf4e-9213c637e3d9 0363-5010 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160527 ANDA ANDA208150 Walgreens FLUTICASONE PROPIONATE 50 ug/1 N 20181231 0363-5020_e3443e68-a4ef-407a-b83f-37dbee7b3ce2 0363-5020 HUMAN OTC DRUG Wal-Phed PE Pressure plus Pain Maximum Strength Non-Drowsy Acetaminophen, Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 0363-5027_47a7757d-1981-4e77-be4b-cfc5dc5fd822 0363-5027 HUMAN OTC DRUG Severe Sinus Daytime, Non-Drowsy Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 0363-5110_4ef5a5b2-c9cd-4e9b-b7bd-ad20eddf3af6 0363-5110 HUMAN OTC DRUG Wal-Phed PE, Multi-Symptom, Non-Drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20140731 20190808 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 0363-5270_5e28faf4-8ab6-4f8a-a8cc-1ca10424117e 0363-5270 HUMAN OTC DRUG Severe Sinus Congestion and Pain Daytime Aceetaminophen, Guaifenesin and Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 0363-5335_3d788650-2349-4193-9fdb-a428ba54acfc 0363-5335 HUMAN OTC DRUG Walgreens Severe Oral Pain Reliever Benzocaine LIQUID ORAL 20120110 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 20 g/100g N 20181231 0363-5336_37c4bcb1-8d4c-43c1-a9b5-a5b4c6b94f92 0363-5336 HUMAN OTC DRUG Walgreens Severe Toothache Relief Benzocaine PASTE, DENTIFRICE TOPICAL 20130801 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 20 g/100g N 20181231 0363-5337_6c7ce16e-31b2-4d49-b8e5-b63131462127 0363-5337 HUMAN OTC DRUG Walgreens Maximum Strength Benzocaine PASTE, DENTIFRICE TOPICAL 20130801 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 20 g/100g N 20181231 0363-5345_5a8606c8-c137-40a8-b3d8-87a70c44f2fa 0363-5345 HUMAN OTC DRUG Infants Gas Relief Non-Staining Formula Dimethicone LIQUID ORAL 20130415 OTC MONOGRAPH FINAL part332 Walgreens DIMETHICONE 20 mg/.3mL E 20171231 0363-5440_4cc5f00b-d67a-4cf9-a113-57daacbb1dc1 0363-5440 HUMAN OTC DRUG Wal-Phed PE Acetaminophen, Diphenhydramine HCl, Phenyelphrine HCl TABLET ORAL 20060919 20181105 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 E 20171231 0363-5460_ca4593f3-eaa9-41e6-8769-35ef6d986e16 0363-5460 HUMAN OTC DRUG Wal-Phed PE Multi Symptom Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20070222 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0363-5523_5e98df09-b1fa-7c6a-e053-2a91aa0a98ef 0363-5523 HUMAN OTC DRUG Salicylic Acid Ultra Thin Corn Removers PATCH TOPICAL 20130730 OTC MONOGRAPH FINAL part358F Walgreens Company SALICYLIC ACID 40 mg/91 N 20181231 0363-5555_2d53f01d-105d-468c-ac0f-6b71b48be8ce 0363-5555 HUMAN OTC DRUG Cooln Heat Micro Well at Walgreens Mentol PATCH TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 Walgreens MENTHOL .75 g/1 N 20181231 0363-5580_5b524d3a-003c-4ffb-a36c-98e15276ec62 0363-5580 HUMAN OTC DRUG Sinus and Headache Daytime, Non-Drowsy Acetaminophen, Phenylephrine HCl TABLET ORAL 20080317 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 0363-5773_e88ebb97-08d3-46d7-921c-9812a1a65360 0363-5773 HUMAN OTC DRUG Infants Gas Relief Non-Staining Formula DIMETHICONE LIQUID ORAL 20130615 OTC MONOGRAPH FINAL part332 Walgreens DIMETHICONE 20 mg/.3mL E 20171231 0363-5780_804f03d1-69c6-4413-aacc-0ab7d78f4a42 0363-5780 HUMAN OTC DRUG childrens Wal-Zyr Cetirizine HCl TABLET, CHEWABLE ORAL 20081031 20181021 ANDA ANDA078692 Walgreen Company CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0363-5820_1a1efd3f-908b-446e-967f-beabe4d6e104 0363-5820 HUMAN OTC DRUG Walgreens Maximum Strength Benzocaine LIQUID DENTAL 20150101 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 20 g/100g N 20181231 0363-5960_51842568-1f0e-44cf-a472-7533171f5e19 0363-5960 HUMAN OTC DRUG Soothe childrens Calcium carbonate TABLET, CHEWABLE ORAL 20110407 OTC MONOGRAPH FINAL part331 Walgreen Company CALCIUM CARBONATE 400 mg/1 N 20191231 0363-6000_2fe61aec-acac-163a-e054-00144ff8d46c 0363-6000 HUMAN OTC DRUG Menthol cough drops Menthol LOZENGE ORAL 20140718 OTC MONOGRAPH FINAL part341 Walgreens MENTHOL 5.8 mg/1 N 20181231 0363-6001_2fe93632-9d7f-665c-e054-00144ff88e88 0363-6001 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20140721 OTC MONOGRAPH FINAL part341 Walgreens MENTHOL 5.4 mg/1 N 20181231 0363-6028_52521d25-8474-4416-a274-4f458ebd328e 0363-6028 HUMAN OTC DRUG Sinus Pressure and Pain Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130503 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 0363-6040_9633b49b-9152-4bdb-9c2e-e6b39b92006a 0363-6040 HUMAN OTC DRUG Medicated Lip Balm Medicated Lip Balm SALVE TOPICAL 20131030 OTC MONOGRAPH NOT FINAL part348 Walgreen Co CAMPHOR (NATURAL); MENTHOL; PHENOL 1.7; .7; .4 mg/g; mg/g; mg/g E 20171231 0363-6048_7ed3d2a9-46f8-4782-8ae4-228513a6ebb5 0363-6048 HUMAN OTC DRUG Severe Congestion and Cough Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20150720 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/1; mg/1; mg/1 N 20181231 0363-6050_04cd52a1-fc2c-4f46-918c-2e907b099316 0363-6050 HUMAN OTC DRUG Lip Balm Sunscreen SPF 4 Original SPF4 Lip Balm STICK TOPICAL 20130901 OTC MONOGRAPH FINAL part352 Walgreen Co PADIMATE O 1.5 mg/g E 20171231 0363-6060_1210cd47-4d41-4c70-9a9b-c8e195733041 0363-6060 HUMAN OTC DRUG Lip Balm Sunscreen SPF 4 Cherry Flavor SPF4 Cherry Lip Balm STICK TOPICAL 20130901 OTC MONOGRAPH FINAL part352 Walgreen Co PADIMATE O 1.5 mg/g E 20171231 0363-6080_6a82dba6-f36e-448c-af67-e98bb33f6da8 0363-6080 HUMAN OTC DRUG Medicated Lip Balm Medicated Lip Balm Stick STICK TOPICAL 20131030 OTC MONOGRAPH NOT FINAL part348 Walgreen Co CAMPHOR (NATURAL); MENTHOL; PHENOL 1.7; .7; .4 mg/g; mg/g; mg/g E 20171231 0363-6160_9d5b6fa0-7e3b-41ca-b757-17eb51a50df7 0363-6160 HUMAN OTC DRUG Cold, Flu, and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0363-6170_eafbdc47-cec8-4198-81e9-ab10d601c4e2 0363-6170 HUMAN OTC DRUG Mucus Relief Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 20190708 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 0363-6175_8eb0d4c9-118a-4a07-bd77-2ea5d3004d55 0363-6175 HUMAN OTC DRUG Mucus Relief Daytime/Nighttime Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Diphenhydramine HCl KIT 20130407 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-6176_91c11c94-e816-4cb4-92d1-51f85fecab07 0363-6176 HUMAN OTC DRUG Severe Cold, Cold and Flu Daytime, Nighttime, Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Diphenhydramine HCl KIT 20170701 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-6230_ed4d22c4-18a9-402c-a48a-5f00e590fbcb 0363-6230 HUMAN OTC DRUG Walgreens Baby Teething Benzocaine GEL, DENTIFRICE ORAL 20110120 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 7.5 g/100g N 20181231 0363-6332_68c4cb46-8956-48b6-971c-37d9867914f1 0363-6332 HUMAN OTC DRUG Walgreens Baby Teething Benzocaine GEL, DENTIFRICE ORAL 20130901 OTC MONOGRAPH FINAL part333B Walgreens BENZOCAINE 7.5 g/100g N 20181231 0363-6406_509a9f1a-ceab-4e81-a43e-90a93dbb4558 0363-6406 HUMAN OTC DRUG Cold and Flu Daytime, Nighttime, Maximum Strength Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl KIT 20150801 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-6406_ca8fe96c-cad5-4a6c-b08a-874b456f1ab1 0363-6406 HUMAN OTC DRUG Cold and Flu Daytime, Nighttime, Maximum Strength Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl KIT 20150801 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-6450_255af8cf-4ad7-4c89-aff6-bdd19e9a77a1 0363-6450 HUMAN OTC DRUG Aspirin Enteric Coated Low Dose Aspirin TABLET, COATED ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ASPIRIN 81 mg/1 N 20181231 0363-6451_1b02a39e-1961-2ca6-e054-00144ff8d46c 0363-6451 HUMAN OTC DRUG Lubricant Eye Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20150716 OTC MONOGRAPH FINAL part349 Walgreens POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 0363-6480_ae684fb3-d475-4bad-9e47-bee04c099a66 0363-6480 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20150720 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/1; mg/1; mg/1 N 20181231 0363-6485_517cce92-5b07-428e-9232-53e21be9cb21 0363-6485 HUMAN OTC DRUG Mucus Relief Daytime/Nighttime/Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl KIT 20150720 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-6489_bf8f01de-df99-47ac-b98f-80e41f92bf7e 0363-6489 HUMAN OTC DRUG Severe Congestion and Cough, Cold and Flu Daytime, Nighttime Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl KIT 20170701 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-6500_4fe33ab0-12fa-212e-e054-00144ff88e88 0363-6500 HUMAN OTC DRUG Homeopathic Medicine Yeast Relief Plus Candida Albicans, Wood Creosote, Sodium Chloride, and Sulfur TABLET ORAL 20170518 UNAPPROVED HOMEOPATHIC WALGREEN CO. CANDIDA ALBICANS; WOOD CREOSOTE; SODIUM CHLORIDE; SULFUR 30; 30; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 0363-6550_1e5225a3-475c-4ea9-8ef6-13b2372d54fd 0363-6550 HUMAN OTC DRUG Laxative Gentle Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH NOT FINAL part334 Walgreen Company DOCUSATE SODIUM 100 mg/1 N 20181231 0363-6580_1adba1fc-3898-4297-b954-e554642915b3 0363-6580 HUMAN OTC DRUG Wal-Dryl Allergy Dye-Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Walgreen Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0363-6590_76e848a7-45f3-42f1-9b1b-01d003dbc6e3 0363-6590 HUMAN OTC DRUG Cold and Flu Daytime/Multi-Symptom/Non-Drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0363-6596_60fd0c09-639b-4ee3-95e3-977417d50701 0363-6596 HUMAN OTC DRUG Cold and Flu Daytime, Nighttime, Multi-Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl KIT 20150301 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-6596_95de41b8-a3ab-4cec-991a-8f56d26fd34d 0363-6596 HUMAN OTC DRUG Cold and Flu Daytime, Nighttime, Multi-Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl KIT 20150301 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-6600_c33bffec-1f82-416d-83c6-bb602dcab4e2 0363-6600 HUMAN OTC DRUG Cold and Flu Nighttime/Multi-Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 0363-6610_4164cb4c-977c-4ae4-9114-db556ab01968 0363-6610 HUMAN OTC DRUG Wal-Tussin Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 0363-6680_84475826-92ba-40d1-b661-788a3715adb7 0363-6680 HUMAN OTC DRUG Allergy Relief Nighttime Diphenhydramine HCl TABLET, FILM COATED ORAL 20150120 20190107 OTC MONOGRAPH FINAL part341 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 0363-6711_92f51fe6-dc8b-499b-ad38-bd6d0347a169 0363-6711 HUMAN OTC DRUG Walgreen Vanishing Scent Muscle and Joint Menthol GEL TOPICAL 20140528 OTC MONOGRAPH NOT FINAL part348 Walgreen Company MENTHOL 2.5 g/100g E 20171231 0363-6770_1408f650-dbc3-45df-a1d7-de7081701661 0363-6770 HUMAN OTC DRUG Cold and Flu Severe, Nighttime, Maximum Strength Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl TABLET, FILM COATED ORAL 20150801 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0363-6771_d159af5b-ddcb-4f65-9833-f38e3a5eb9d5 0363-6771 HUMAN OTC DRUG Walgreens Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20140528 OTC MONOGRAPH FINAL part347 Walgreen Company ZINC OXIDE 40 g/100g N 20181231 0363-6780_39008be3-0991-47fa-972e-30ab1dcac6a6 0363-6780 HUMAN OTC DRUG Pain Reliever Regular Strength Acetaminophen TABLET ORAL 20150724 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 325 mg/1 N 20181231 0363-6842_c0eeb53a-ebda-46da-83ca-517d873c30fd 0363-6842 HUMAN OTC DRUG Walgreens Dual Action Lubricant Eye Carboxymethylcellulose sodium, and Glycerin SOLUTION/ DROPS OPHTHALMIC 20141223 OTC MONOGRAPH FINAL part349 Walgreen Company CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 0363-6880_7b3df5c2-96b2-4fd5-a526-89ca1a214e6d 0363-6880 HUMAN OTC DRUG Walgreens Pain Relieving for Boils Benzocaine OINTMENT TOPICAL 20140528 OTC MONOGRAPH FINAL part333B Walgreen Company BENZOCAINE 20 g/100g N 20181231 0363-6890_25ef5dbd-6a43-49ec-9345-f31ba58f6106 0363-6890 HUMAN OTC DRUG Cough and Cold HBP Maximum Strength Chlorpheniramine Maleate, Dextromethorphan Hbr TABLET, COATED ORAL 20170515 OTC MONOGRAPH FINAL part341 Walgreen Company CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 0363-7000_13321d19-6077-4cb2-8ecd-afc8ecbd5b70 0363-7000 HUMAN OTC DRUG Nasal Mist Walgreens Oxymetazoline Hydrochloride 0.05% LIQUID TOPICAL 20160701 OTC MONOGRAPH FINAL part341 Walgreens OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 0363-7001_8ea510f9-d5be-47c9-a3f9-8a9b513449aa 0363-7001 HUMAN OTC DRUG Severe Congestion Nasal no drip Walgreens Oxymetazoline Hydrochloride 0.05% LIQUID TOPICAL 20160701 OTC MONOGRAPH FINAL part341 Walgreens OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 0363-7002_bf038212-b43a-487f-81ed-5d3eef1d90fc 0363-7002 HUMAN OTC DRUG Cooln Heat Muscle Rub Well at Walgreens Menthol GEL TOPICAL 20160711 OTC MONOGRAPH NOT FINAL part348 Walgreens MENTHOL 2.5 g/100mL N 20181231 0363-7003_a30949d6-5ffb-4b37-8d31-54756f8cc0df 0363-7003 HUMAN OTC DRUG Maximum Strenth Nasal Oxymetazoline Hydrochloride - 0.05% LIQUID TOPICAL 20160715 OTC MONOGRAPH FINAL part341 Walgreens OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 0363-7004_c9d69275-9c58-4ce1-ac02-b83a8a6f27c9 0363-7004 HUMAN OTC DRUG Extra Moisturizing No Drip Nasal Walgreens Oxymetazoline Hydrochloride - 0.05% LIQUID TOPICAL 20160701 OTC MONOGRAPH FINAL part341 Walgreens OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 0363-7005_6684bb5e-ecfc-433d-84c6-26c7cb469d8c 0363-7005 HUMAN OTC DRUG Original No Drip Nasal Walgreens Oxymetazoline Hydrochloride - 0.05% LIQUID TOPICAL 20160701 OTC MONOGRAPH FINAL part341 Walgreens OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20191231 0363-7006_7610be65-c112-43c7-84c8-577710749243 0363-7006 HUMAN OTC DRUG Pain releiving Well at Walgreens Camphor 3.1 Menthol 6.0 Meththyl salicylate 10.0 PATCH TOPICAL 20160716 OTC MONOGRAPH NOT FINAL part348 Walgreens CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE .0124; .024; .04 g/1; g/1; g/1 N 20181231 0363-7110_90832dbe-f8d5-442e-bda3-24040ad22f38 0363-7110 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20130327 OTC MONOGRAPH NOT FINAL part333E Walgreen Co. BENZALKONIUM CHLORIDE 1.2478 g/L N 20181231 0363-7210_38b15b88-6abc-4e02-9b27-78ecf591997e 0363-7210 HUMAN OTC DRUG STUDIO 35 BEAUTY AMBER ANTIBACTERIAL REFILL BENZALKONIUM CHLORIDE LIQUID TOPICAL 20150319 OTC MONOGRAPH NOT FINAL part333E WALGREEN COMPANY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 0363-7215_1e0b6871-f060-43ba-aa12-0313c31a39e1 0363-7215 HUMAN OTC DRUG STUDIO 35 AMBER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part333E WALGREEN COMPANY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 0363-7220_df022a54-279e-4c8c-af91-3c54c7fba69d 0363-7220 HUMAN OTC DRUG Walgreens Lubricant Eye Drops Polyethylen Glycol and Propylene Gloycol SOLUTION/ DROPS OPHTHALMIC 20140806 OTC MONOGRAPH FINAL part349 Walgreen Company POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mg/100mg; mg/100mg N 20181231 0363-7267_6ba77af7-4136-4810-84a6-a22b52bfe3fb 0363-7267 HUMAN OTC DRUG Walgreens Lubricant Eye Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20150721 OTC MONOGRAPH FINAL part349 Walgreen Company POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 0363-7274_406606f3-9aec-492e-9e13-8d58be6ea6cc 0363-7274 HUMAN OTC DRUG Walgreens Sterile Lubricant Eye Mineral oil, and White petrolatum OINTMENT OPHTHALMIC 20150727 OTC MONOGRAPH FINAL part349 Walgreen Company MINERAL OIL; PETROLATUM 425; 573 mg/g; mg/g N 20181231 0363-7281_6b45e2fb-4ecd-4777-8a30-e0b7ec058535 0363-7281 HUMAN OTC DRUG Well at Walgreens Sterile Lubricant Eye Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20150720 OTC MONOGRAPH FINAL part349 Walgreens Company CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 0363-7298_4f8da34e-299e-4f2a-ad0b-0552a67bdee1 0363-7298 HUMAN OTC DRUG Walgreens Sterile Original Eye Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20150727 OTC MONOGRAPH FINAL part349 Walgreen Company TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 0363-7412_15f23c28-22cf-407c-9aaf-ac16ba631f42 0363-7412 HUMAN OTC DRUG Walgreens Clotrimazole Antifungal Clotrimazole CREAM TOPICAL 20150518 OTC MONOGRAPH FINAL part333C Walgreen Company CLOTRIMAZOLE 1 g/100g N 20181231 0363-7630_6eae97f3-a174-4cbc-badc-777475d2f7af 0363-7630 HUMAN OTC DRUG Walgreens Fast Acting Heartburn Relief Extra Strength aluminum hydroxide and magnesium carbonate LIQUID ORAL 20180115 OTC MONOGRAPH FINAL part331 WALGREEN CO. ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 254; 237.5 mg/5mL; mg/5mL N 20181231 0363-7730_5e98df09-b217-7c6a-e053-2a91aa0a98ef 0363-7730 HUMAN OTC DRUG Salicylic Acid Extra Thick Callus Removers PATCH TOPICAL 20120816 OTC MONOGRAPH FINAL part358F Walgreen Company SALICYLIC ACID 40 mg/41 N 20181231 0363-7731_5e979013-18a3-4cfd-e053-2991aa0ae484 0363-7731 HUMAN OTC DRUG Undecylenic Acid Anti-Fungal Liquid LIQUID TOPICAL 20120816 OTC MONOGRAPH FINAL part333C Walgreen Company UNDECYLENIC ACID .25 g/g N 20181231 0363-7746_1b1d756e-bb5d-54f8-e054-00144ff88e88 0363-7746 HUMAN OTC DRUG Walgreens Artifical Tears Free dextran 70, hypromellose SOLUTION/ DROPS OPHTHALMIC 20150716 OTC MONOGRAPH FINAL part349 Walgreens HYPROMELLOSE 2910 (4000 MPA.S); DEXTRAN 70 3; 1 mg/mL; mg/mL N 20181231 0363-7776_23490017-a59a-415b-b402-02fbc44e2fda 0363-7776 HUMAN OTC DRUG Walgreens Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20150115 UNAPPROVED DRUG OTHER Walgreens PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 0363-7864_b9f1f2d1-c17b-46e5-9248-c6ad0de6f94c 0363-7864 HUMAN OTC DRUG Walgreen Sterile Lubricant Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20150727 OTC MONOGRAPH FINAL part349 Walgreen Company PROPYLENE GLYCOL .06 mg/mL N 20181231 0363-7872_3992bf44-f037-4b0a-aa58-3537be57ac75 0363-7872 HUMAN OTC DRUG Walgreens Maximum Strength Triple Antibiotic With Pain Relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine HCL OINTMENT TOPICAL 20150513 OTC MONOGRAPH FINAL part333B Walgreen Co. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 1000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 0363-8000_af5068af-0342-c628-c948-cf4859e11c76 0363-8000 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 19971020 ANDA ANDA074612 Walgreens NICOTINE 7 mg/24h N 20181231 0363-8001_af5068af-0342-c628-c948-cf4859e11c76 0363-8001 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 19971020 ANDA ANDA074612 Walgreens NICOTINE 14 mg/24h N 20181231 0363-8002_af5068af-0342-c628-c948-cf4859e11c76 0363-8002 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 19971020 ANDA ANDA074612 Walgreens NICOTINE 21 mg/24h N 20181231 0363-8042_52b66fb9-0abb-4229-87ad-d37c66cf75a0 0363-8042 HUMAN OTC DRUG Tolnaftate Athletes Foot Liquid SPRAY TOPICAL 20090311 OTC MONOGRAPH FINAL part333C Walgreens Company TOLNAFTATE 1.5 g/150g N 20181231 0363-8127_8bea2fa1-ff9e-4522-9de0-48ecf0e0fa90 0363-8127 HUMAN OTC DRUG Walgreens Muscle Rub Ulra Strength Camphor, Menthol, Methyl salicylate CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Walgreen Company CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g N 20181231 0363-8130_5c786c79-1ba2-4c96-93ea-0e91437e9c73 0363-8130 HUMAN OTC DRUG Walgreens Maximum Strength Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B walgreens BENZOCAINE 20 g/100g N 20181231 0363-8190_54c70e20-f28c-42b8-b412-1ad5a757736e 0363-8190 HUMAN OTC DRUG Walgreens Chap Aid Moisturizer octinoxate, oxybenzone, white petrolatum STICK TOPICAL 20150701 OTC MONOGRAPH FINAL part352 Walgreen Company OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 407 mg/g; mg/g; mg/g N 20181231 0363-8201_81d0a950-23da-44da-ba25-d4164a2ca7bb 0363-8201 HUMAN OTC DRUG Walgreens Peroxide Whitening Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 Walgreens SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 0363-8202_eae11f67-f862-4cf7-86f7-b41eb7160e06 0363-8202 HUMAN OTC DRUG Walgreens Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Walgreens SODIUM FLUORIDE .243 g/100g N 20181231 0363-8203_d325bc79-6215-4ccf-afb7-b3b1d6ae77ab 0363-8203 HUMAN OTC DRUG Walgreens Sulfate Free Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 Walgreens SODIUM FLUORIDE .24 g/100g N 20181231 0363-8204_a7f923e7-43a3-468a-a1e6-6f61c5d0d9b1 0363-8204 HUMAN OTC DRUG Walgreens Stain Care Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 Walgreens SODIUM FLUORIDE .243 g/100g N 20181231 0363-8217_5e99c787-c588-173f-e053-2991aa0a54bf 0363-8217 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20080623 OTC MONOGRAPH FINAL part358F Walgreen Company SALICYLIC ACID .17 g/g N 20181231 0363-8280_4e91308c-7ee8-42b3-abd4-caf661668db7 0363-8280 HUMAN OTC DRUG WELL AT WALGREENS PINK GRAPEFRUIT SALICYLIC ACID LIQUID TOPICAL 20151208 OTC MONOGRAPH FINAL part333D WALGREEN COMPANY SALICYLIC ACID 20 mg/mL N 20181231 0363-8396_19d6e254-525a-443b-bf28-e05a7323e1f6 0363-8396 HUMAN OTC DRUG Eye Lubricant polyethylene glycol, propylene glycol LIQUID OPHTHALMIC 20121205 OTC MONOGRAPH FINAL part349 Walgreen Company POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/10mL; mg/10mL N 20181231 0363-8410_1a59428d-127c-4625-af48-69f8314bdb1b 0363-8410 HUMAN OTC DRUG Studio35 Extra Strength Medicated Body Dimethicone and Menthol LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part347 Walgreen Company DIMETHICONE; MENTHOL 5; .5 g/100mL; g/100mL N 20181231 0363-8480_8a1ed5c5-3fb6-4d01-aa35-b40fa52a4b87 0363-8480 HUMAN OTC DRUG Chest Rub camphor, eucalyptus oil, menthol LOTION TOPICAL 20140716 OTC MONOGRAPH FINAL part341 Walgreens Company CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/42.5g; kg/42.5g; kg/42.5g E 20171231 0363-8588_5e98b2ab-0194-641d-e053-2991aa0ad4c1 0363-8588 HUMAN OTC DRUG Calamine Plus Pramoxine HCl Calamine Plus No-Touch AEROSOL, SPRAY TOPICAL 20130312 OTC MONOGRAPH NOT FINAL part348 Walgreens Company FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE .345; 24.16; 2.72 mg/177mL; mg/177mL; mg/177mL N 20181231 0363-8589_cff1a024-530f-48e1-bb1d-3eafc0f90188 0363-8589 HUMAN OTC DRUG Walgreens Daytime non-drowsy cold multi-symptom for adults acetaminophen, phenylephrine hydrochloride and dextromethorphan hydrobromide LIQUID ORAL 20150527 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 0363-8590_8cff2c29-492f-4e43-8b8c-89dfe6f78caa 0363-8590 HUMAN OTC DRUG NightTime Pain Reliever PM acetaminophen, diphenhydramine hydrochloride LIQUID ORAL 20150608 OTC MONOGRAPH NOT FINAL part343 WALGREEN CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/15mL; mg/15mL N 20181231 0363-8591_06a244f6-5a68-4deb-9e02-7ed2eeb411e0 0363-8591 HUMAN OTC DRUG Walgreens Severe Cold Multi-Symptom For Adults acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride LIQUID ORAL 20150527 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 0363-8592_9afe3a38-5928-4f90-b8eb-245ac78fad92 0363-8592 HUMAN OTC DRUG Walgreens Severe Warming Cold and Flu For Adults acetaminophen, dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride LIQUID ORAL 20150527 OTC MONOGRAPH FINAL part341 WALGREEN CO. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 0363-8821_a50cbf06-50d7-4e6f-a1fd-03efc9d979c7 0363-8821 HUMAN OTC DRUG Walgreens Wal-Sporin First Aid Antibiotic Bacitracin, and Polymyxin B OINTMENT TOPICAL 20161004 OTC MONOGRAPH FINAL part333B Walgreen Co. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 0363-9001_a3977373-d906-48e6-9803-34a65adcf2b9 0363-9001 HUMAN OTC DRUG Athlet Foot Well at Walgreens Miconazole Nitrate POWDER TOPICAL 20150415 OTC MONOGRAPH FINAL part333C Walgreens MICONAZOLE NITRATE 2 g/100mL N 20181231 0363-9020_e516a156-209d-4f69-8ebc-9a53e8d98f20 0363-9020 HUMAN OTC DRUG Homeopathic Ear Pain Relief Chamomilla and Mercurius solubilis and Sulphur SOLUTION AURICULAR (OTIC) 20071201 UNAPPROVED HOMEOPATHIC Walgreen Co CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR 10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 0363-9021_828dd539-9ef9-4bce-9a5d-c67cf686d4df 0363-9021 HUMAN OTC DRUG Ear Ease Chamomile and Mercurius Solubilis and Sulphur SOLUTION AURICULAR (OTIC) 20121214 UNAPPROVED HOMEOPATHIC Walgreen Company CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR 10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 0363-9030_c0aaf0e0-1df7-480a-835e-3ba9f4146222 0363-9030 HUMAN OTC DRUG Pink Eye Remedy Belladonna and Euphrasia and Hepar sulphuris SOLUTION/ DROPS OPHTHALMIC 20071201 UNAPPROVED HOMEOPATHIC Walgreen Co ATROPA BELLADONNA; EUPHRASIA STRICTA; CALCIUM SULFIDE 6; 6; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 0363-9031_7571e1f3-981a-4141-ba71-261f4bed6fa2 0363-9031 HUMAN OTC DRUG Irritated Eye Atropa Belladonna and Calcium Sulfide and Euphrasia Stricta SOLUTION/ DROPS OPHTHALMIC 20121214 UNAPPROVED HOMEOPATHIC Walgreen Company ATROPA BELLADONNA; EUPHRASIA STRICTA; CALCIUM SULFIDE 6; 6; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 0363-9040_26df26f3-998e-4bf2-8e36-bca2d859a7d5 0363-9040 HUMAN OTC DRUG Sodium Chloride Sodium Chloride SOLUTION/ DROPS OPHTHALMIC 20130212 OTC MONOGRAPH FINAL part349 Walgreens SODIUM CHLORIDE 50 mg/mL N 20181231 0363-9050_1e23c7c0-f1fd-441d-bc22-8b907bb1451b 0363-9050 HUMAN OTC DRUG Sodium Chloride Sodium Chloride OINTMENT OPHTHALMIC 20130212 OTC MONOGRAPH FINAL part349 Walgreens SODIUM CHLORIDE 50 mg/g N 20181231 0363-9060_be36157a-5731-40cd-bea1-25a7214c26a0 0363-9060 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20130125 ANDA ANDA077958 Walgreens KETOTIFEN FUMARATE .25 mg/mL N 20191231 0363-9113_dff99bd0-c214-40a3-81c2-7d1817c9003a 0363-9113 HUMAN OTC DRUG Walgreens Capsaicin Hot Capsaicin Extract PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Walgreen Co CAPSAICIN .6 mg/1 N 20181231 0363-9114_1356fce1-8340-4d4e-8e73-784f94a5ebaa 0363-9114 HUMAN OTC DRUG Calamine Calamine, Pramoxind HCl LOTION TOPICAL 20170307 OTC MONOGRAPH FINAL part347 Walgreen CO FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 8.6; 20; 10 mg/mL; mg/mL; mg/mL N 20181231 0363-9115_4fa43541-968f-438a-94b2-f90818c133b6 0363-9115 HUMAN OTC DRUG Clear Anti-Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 20170307 OTC MONOGRAPH FINAL part347 Walgreen CO PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 1; .1 mg/mL; mg/mL N 20181231 0363-9120_48ad00e8-96f3-4787-b817-5343f1b8bddf 0363-9120 HUMAN OTC DRUG Wal-Phed PE Pressure plus Pain plus Cold Daytime, Nighttime, Multi-Symptom Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl KIT 20070222 OTC MONOGRAPH FINAL part341 Walgreen Company N 20181231 0363-9160_9b3a6dda-2af0-411e-84fa-fddb0246585e 0363-9160 HUMAN OTC DRUG Maximum Strength Diaper Rash Zinc Oxide CREAM TOPICAL 20140501 OTC MONOGRAPH FINAL part347 Walgreen Company ZINC OXIDE 40 g/100g N 20181231 0363-9170_53f1cc6c-4021-4256-9f2a-c50aac793b2d 0363-9170 HUMAN OTC DRUG NICOTINE nicotine polacrilex LOZENGE ORAL 20110714 NDA NDA021330 Walgreens NICOTINE 2 mg/1 N 20181231 0363-9171_53f1cc6c-4021-4256-9f2a-c50aac793b2d 0363-9171 HUMAN OTC DRUG NICOTINE nicotine polacrilex LOZENGE ORAL 20110714 NDA NDA021330 Walgreens NICOTINE 4 mg/1 N 20181231 0363-9175_98bc9533-8d61-4143-9a00-cf62c940b5a1 0363-9175 HUMAN OTC DRUG Wal-Nadol Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 500 mg/1 N 20181231 0363-9181_004381d2-7ec8-47cd-91f1-3e84654d4abe 0363-9181 HUMAN OTC DRUG Wal Dryl Diphenhydramine Hydrochloride SOLUTION ORAL 20160425 OTC MONOGRAPH FINAL part341 WALGREEN CO. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/20mL N 20181231 0363-9200_53f1cc6c-4021-4256-9f2a-c50aac793b2d 0363-9200 HUMAN OTC DRUG NICOTINE nicotine polacrilex LOZENGE ORAL 20110714 NDA NDA021330 Walgreens NICOTINE 4 mg/1 N 20181231 0363-9221_5efa2c38-b426-a93e-e053-2991aa0a6060 0363-9221 HUMAN OTC DRUG Witch Hazel Witch Hazel Spray SPRAY TOPICAL 20170301 OTC MONOGRAPH FINAL part347 Walgreens Company WITCH HAZEL 146 g/170g N 20181231 0363-9247_23e3385d-e37c-4a2d-bd8b-64b1263d3311 0363-9247 HUMAN OTC DRUG Advanced Healing Petrolatum OINTMENT TOPICAL 20130827 OTC MONOGRAPH FINAL part347 Walgreen Co PETROLATUM 340 mg/100g N 20181231 0363-9300_3eab2080-7dfc-4d61-90b8-5fafa56191cf 0363-9300 HUMAN OTC DRUG Well at Walgreens Advanced Hand Sanitizer with Vitamin E Ethyl Alcohol LIQUID TOPICAL 20150715 OTC MONOGRAPH NOT FINAL part333A Walgreens Co. ALCOHOL 70 mL/100mL N 20181231 0363-9320_ab82e32f-647d-44c3-bc89-ee24cfc877af 0363-9320 HUMAN OTC DRUG WALGREENS INSTANT HAND SANITIZER ETHYL ALCOHOL SPRAY TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333E WALGREEN CO ALCOHOL 62 mL/100mL E 20171231 0363-9362_151485de-cf01-408e-9869-d12833182129 0363-9362 HUMAN OTC DRUG Walgreens Wrinkle Repair Moisturizer SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20130105 OTC MONOGRAPH NOT FINAL part352 Walgreens Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 4; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 0363-9425_8e992180-ca87-4aba-9689-82263561b392 0363-9425 HUMAN OTC DRUG Walgreens Camphor Phenol Gel Camphor, Phenol GEL TOPICAL 20170831 OTC MONOGRAPH NOT FINAL part348 Walgreens CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 mg/g; mg/g N 20181231 0363-9440_1544ba06-20f4-4ac2-b203-3f182d780efa 0363-9440 HUMAN OTC DRUG Pain and Fever Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Walgreen Company ACETAMINOPHEN 160 mg/1 N 20181231 0363-9527_7f49828e-8584-4f9e-a3ba-3e80c45fee53 0363-9527 HUMAN OTC DRUG Cold and Head Congestion Severe/Daytime Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 Walgreen Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 0363-9529_ab93ed6b-1585-4997-b5cc-bc30036c86c2 0363-9529 HUMAN OTC DRUG Walgreens Anticavity and Antigingivitis Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Walgreen SODIUM FLUORIDE 2.43 mg/g E 20171231 0363-9650_fa931256-b009-4c7b-a376-0dc95b7207bc 0363-9650 HUMAN OTC DRUG Naphazoline Hydrochloride and Pheniramine Maleate Naphazoline hydrochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20130423 ANDA ANDA202795 Walgreens NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL N 20181231 0363-9651_07330058-deaa-4404-b675-2ec8b9abc491 0363-9651 HUMAN OTC DRUG Moisturizing Lubricant Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20150624 OTC MONOGRAPH FINAL part349 Walgreens CARBOXYMETHYLCELLULOSE SODIUM 2.5 mg/mL N 20191231 0363-9688_ff32ace0-2999-435f-9fb6-0f12fbfaf3b6 0363-9688 HUMAN OTC DRUG Walgreens Anti-Sagging and Ultra Hydrating Day Broad Spectrum SPF15 Sunscreen Avobenzone, Oxybenzone, Octocrylene CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part352 Walgreen Company AVOBENZONE; OXYBENZONE; OCTOCRYLENE 3; 2; 10 g/100g; g/100g; g/100g N 20181231 0363-9757_5e98df09-b1e6-7c6a-e053-2a91aa0a98ef 0363-9757 HUMAN OTC DRUG Salicylic Acid Corn Removers PATCH TOPICAL 20080722 OTC MONOGRAPH FINAL part358F Walgreen Company SALICYLIC ACID 40 mg/91 N 20181231 0363-9839_b8316be3-f158-49bb-8ca2-d29d1823ec4a 0363-9839 HUMAN OTC DRUG childrens multi symptom cold dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20150627 OTC MONOGRAPH FINAL part341 Walgreen Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 0363-9889_5e996df3-2593-b259-e053-2a91aa0a4311 0363-9889 HUMAN OTC DRUG Salicylic Acid Liquid corn and Callus remover LIQUID TOPICAL 20080709 OTC MONOGRAPH FINAL part358F Walgreen Company SALICYLIC ACID .17 g/g N 20181231 0363-9890_60276fcc-ae8d-7ead-e053-2991aa0a5ada 0363-9890 HUMAN OTC DRUG SEVERE SINUS CONGESTION AND COUGH DAYTIME NON-DROWSY / NIGHTIME ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE KIT 20150815 OTC MONOGRAPH NOT FINAL part343 Walgreens N 20181231 0363-9891_19fbf508-cf6a-48b0-86c4-5fa1cda3b1ca 0363-9891 HUMAN OTC DRUG MUCUS RELIEF DM GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20150815 OTC MONOGRAPH FINAL part341 Walgreens GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 0363-9891_5efb496f-bc26-d683-e053-2a91aa0a9da3 0363-9891 HUMAN OTC DRUG Salicylic Acid One step Wart Remover Clear Strips PLASTER TOPICAL 20110520 OTC MONOGRAPH FINAL part358B Walgreens Company SALICYLIC ACID 40 mg/141 N 20181231 0363-9892_6017de95-ac32-01dc-e053-2991aa0ade7e 0363-9892 HUMAN OTC DRUG COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20150815 OTC MONOGRAPH FINAL part341 Walgreens ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 0363-9893_603cc06c-23a5-063a-e053-2a91aa0aa202 0363-9893 HUMAN OTC DRUG PAIN RELIEVER REGULAR STRENGTH ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20151215 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN 325 mg/1 N 20181231 0363-9894_603d483b-3319-434a-e053-2a91aa0a5369 0363-9894 HUMAN OTC DRUG HEADACHE RELIEF PM ACETAMINOPHEN, ASPIRIN, and DIPHENHYDRAMINE CITRATE TABLET, FILM COATED ORAL 20160215 OTC MONOGRAPH NOT FINAL part343 Walgreens ACETAMINOPHEN; ASPIRIN; DIPHENHYDRAMINE CITRATE 250; 250; 38 mg/1; mg/1; mg/1 N 20181231 0363-9895_54c44600-4f90-2711-e054-00144ff8d46c 0363-9895 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20170720 OTC MONOGRAPH FINAL part338 WALGREENS DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 0363-9900_42ebe901-2eea-4251-9f73-9ae171153b37 0363-9900 HUMAN OTC DRUG Walgreens Cool n Heat Muscle and Joint Pain Relief Extra Strength Menthol, Methyl salicylate CREAM TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 Walgreen Company MENTHOL; METHYL SALICYLATE 100; 300 mg/g; mg/g N 20181231 0363-9919_e8dd78fa-e537-4523-833d-21d554912d4a 0363-9919 HUMAN OTC DRUG WALG AFTRSN BURN RELIEF LIDOCAINE HYDROCHLORIDE SPRAY TOPICAL 20171130 OTC MONOGRAPH NOT FINAL part348 Walgreen Company LIDOCAINE HYDROCHLORIDE .5 mg/100mg N 20181231 0363-9921_24c9be49-a788-49fd-ba52-2ca5d4b5dd63 0363-9921 HUMAN OTC DRUG Walgreens Sun Kids SPF50 avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20171115 OTC MONOGRAPH NOT FINAL part352 Walgreen Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 4.5; 8 g/100g; g/100g; g/100g; g/100g N 20181231 0363-9922_3de8c0a2-1acd-4fb2-b7e4-b35fbae53ed2 0363-9922 HUMAN OTC DRUG Walgreens sunscreen Clear Zinc SPF50 octocrylene, zinc oxide LOTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 Walgreen Company OCTOCRYLENE; ZINC OXIDE 4; 5 g/100g; g/100g N 20181231 0363-9923_cb160df0-d4be-42dc-8fc3-f0d5a7d1022d 0363-9923 HUMAN OTC DRUG Walgreen Clear Complexion avobenzone, homosalate, octocrylene, octisalate, oxybenzone LOTION TOPICAL 20171115 OTC MONOGRAPH NOT FINAL part352 Walgreen Company AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 3; 13; 7; 5; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 0363-9924_a185a5eb-8324-4ae6-9905-b5ead960f590 0363-9924 HUMAN OTC DRUG Walgreens Sun Kids SPF50 avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20171115 OTC MONOGRAPH NOT FINAL part352 Walgreen Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 4.5; 8 g/100g; g/100g; g/100g; g/100g N 20181231 0363-9926_25dc78b3-e0fa-4685-94d2-62725d29a04d 0363-9926 HUMAN OTC DRUG Walgreens Baby SPF50 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20170825 OTC MONOGRAPH NOT FINAL part352 Walgreen Company TITANIUM DIOXIDE; ZINC OXIDE 3.1; 4 mg/100mL; mg/100mL N 20181231 0363-9936_71378623-bd71-430b-9f1c-cf4efd8da296 0363-9936 HUMAN OTC DRUG Walgreens Baby SPF50 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20171115 OTC MONOGRAPH NOT FINAL part352 Walgreen Company TITANIUM DIOXIDE; ZINC OXIDE 3.1; 4 mg/100mg; mg/100mg N 20181231 0372-0004_c863b9be-68be-404d-8a21-16237bbcf43e 0372-0004 HUMAN OTC DRUG Scot-Tussin Original SF Multi-Symptom Acetominophen, Phenylephrine Hydrochloride and Pheniramine Maleate LIQUID ORAL 19561201 OTC MONOGRAPH FINAL part341 SCOT-TUSSIN Pharmacal Co., Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; PHENIRAMINE MALEATE 160; 4; 4 mg/5mL; mg/5mL; mg/5mL N 20181231 0372-0006_a02a5ca8-8c0d-4be5-92b1-5271d555f252 0372-0006 HUMAN OTC DRUG Scot-Tussin Expectorant SF Cough Guaifenesin LIQUID ORAL 19740701 OTC MONOGRAPH FINAL part341 SCOT-TUSSIN Pharmacal Co., Inc. GUAIFENESIN 100 mg/5mL N 20181231 0372-0036_88da39ce-b25d-4403-96e2-82277b4f01d7 0372-0036 HUMAN OTC DRUG Scot-Tussin DM SF Maximum Strength Cough Cold Dextromethorphan Hydrobromide Chlorpheniramine Maleate LIQUID ORAL 19830928 OTC MONOGRAPH FINAL part341 SCOT-TUSSIN Pharmacal Co., Inc. DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE 15; 2 mg/5mL; mg/5mL N 20181231 0372-0043_ba9ffd36-c22d-47c5-ab0a-954791e8ddd5 0372-0043 HUMAN OTC DRUG Scot-Tussin Diabetes Cough Formula with DM dextromethorphan hydrobromide LIQUID ORAL 19980318 OTC MONOGRAPH FINAL part341 SCOT-TUSSIN Pharmacal Co., Inc. DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL N 20181231 0372-0050_29bdfa32-2dde-4ea0-a23a-6b68ed05d44f 0372-0050 HUMAN OTC DRUG Scot-Tussin Senior SF DMEXP Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 19991207 OTC MONOGRAPH FINAL part341 SCOT-TUSSIN Pharmacal Co., Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 15; 200 mg/5mL; mg/5mL N 20181231 0374-5050_e3bff707-ef5e-4ce1-991c-3d59c6bb74de 0374-5050 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20100830 ANDA ANDA040879 Lyne Laboratories, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0374-5060_21232d35-46e6-0457-e054-00144ff8d46c 0374-5060 HUMAN PRESCRIPTION DRUG Erythromycin and Benzoyl Peroxide Erythromycin and Benzoyl Peroxide GEL TOPICAL 20151201 ANDA ANDA065385 Lyne Laboratories, Inc. ERYTHROMYCIN; BENZOYL PEROXIDE 30; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0374-5070_2faceeee-7e4a-3a9c-e054-00144ff88e88 0374-5070 HUMAN PRESCRIPTION DRUG CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) CLINDAMYCIN PALMITATE HYDROCHLORIDE GRANULE, FOR SOLUTION ORAL 20120911 ANDA ANDA201821 Lyne Laboratories, Inc. CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0374-5080_56311781-d9a5-3feb-e054-00144ff88e88 0374-5080 HUMAN PRESCRIPTION DRUG CHLORHEXIDINE GLUCONATE chlorhexidine gluconate RINSE ORAL 20171101 ANDA ANDA074291 Lyne Laboratories, Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 0374-5090_326b872f-bb48-590b-e054-00144ff8d46c 0374-5090 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Oil Fluocinolone Acetonide Oil OIL TOPICAL 20160701 ANDA ANDA090982 Lyne Laboratories, Inc. FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0374-5100_326dda90-4248-3291-e054-00144ff88e88 0374-5100 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Oil Fluocinolone Acetonide Oil OIL TOPICAL 20160701 ANDA ANDA203377 Lyne Laboratories, Inc. FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0374-5110_326dd0b1-44c4-5dc6-e054-00144ff8d46c 0374-5110 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Oil Fluocinolone Acetonide Oil OIL AURICULAR (OTIC) 20160701 ANDA ANDA203378 Lyne Laboratories, Inc. FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0374-5150_5643666f-7a03-1687-e054-00144ff88e88 0374-5150 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20170901 ANDA ANDA208838 Lyne Laboratories, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0378-0001_f030a2c7-4bb0-462b-b59a-7b4fbd140055 0378-0001 HUMAN PRESCRIPTION DRUG Clorpres clonidine hydrochloride and chlorthalidone TABLET ORAL 19980313 20180228 ANDA ANDA071325 Mylan Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE; CHLORTHALIDONE .1; 15 mg/1; mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0378-0014_e0ec3882-fdcf-490f-b8d6-d843b937197f 0378-0014 HUMAN PRESCRIPTION DRUG Methotrexate methotrexate TABLET ORAL 19920518 ANDA ANDA081235 Mylan Pharmaceuticals Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 0378-0018_e478b6e4-7c6c-4a8f-a68d-a00507008ef7 0378-0018 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20040223 ANDA ANDA076704 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0023_9dfb72a7-8a81-402c-959c-5e33f45d829c 0378-0023 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19920316 ANDA ANDA072838 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0378-0027_f030a2c7-4bb0-462b-b59a-7b4fbd140055 0378-0027 HUMAN PRESCRIPTION DRUG Clorpres clonidine hydrochloride and chlorthalidone TABLET ORAL 19980313 20180228 ANDA ANDA071325 Mylan Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE; CHLORTHALIDONE .2; 15 mg/1; mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0378-0028_af74832c-d5c4-4c96-ad1c-5f6c228f09ce 0378-0028 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 19931031 ANDA ANDA074172 Mylan Pharmaceuticals Inc. NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0030_0eb4b0da-2c8a-417c-accf-3fc6a0a4aaad 0378-0030 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 19870717 ANDA ANDA071858 Mylan Pharmaceuticals Inc. CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-0032_e478b6e4-7c6c-4a8f-a68d-a00507008ef7 0378-0032 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19931223 ANDA ANDA076704 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0040_0eb4b0da-2c8a-417c-accf-3fc6a0a4aaad 0378-0040 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 19870717 ANDA ANDA071858 Mylan Pharmaceuticals Inc. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-0042_2adf5b79-2f12-42d7-a4ac-910e7cb3ce71 0378-0042 HUMAN PRESCRIPTION DRUG Perphenazine and Amitriptyline Hydrochloride perphenazine and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19881110 ANDA ANDA071443 Mylan Pharmaceuticals Inc. PERPHENAZINE; AMITRIPTYLINE HYDROCHLORIDE 4; 10 mg/1; mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] N 20181231 0378-0045_9dfb72a7-8a81-402c-959c-5e33f45d829c 0378-0045 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19920316 ANDA ANDA072838 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0378-0047_e478b6e4-7c6c-4a8f-a68d-a00507008ef7 0378-0047 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19931223 ANDA ANDA076704 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0048_dd02831e-108a-44be-abde-e6cb658a6c16 0378-0048 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 ANDA ANDA076801 Mylan Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 0378-0052_b897829b-df47-4401-8a52-a8db8f2cfcf4 0378-0052 HUMAN PRESCRIPTION DRUG Pindolol pindolol TABLET ORAL 19920903 ANDA ANDA074019 Mylan Pharmaceuticals Inc. PINDOLOL 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0053_f45db833-cec2-45d8-8b5f-ca1e820b8f48 0378-0053 HUMAN PRESCRIPTION DRUG Cimetidine cimetidine TABLET, FILM COATED ORAL 19940517 ANDA ANDA074246 Mylan Pharmaceuticals Inc. CIMETIDINE 200 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0378-0055_cb884a5e-bc13-43d8-9b2f-f3ee50db896c 0378-0055 HUMAN PRESCRIPTION DRUG Timolol Maleate timolol maleate TABLET ORAL 19900608 ANDA ANDA072668 Mylan Pharmaceuticals Inc. TIMOLOL MALEATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0060_8ab0b141-aa2a-4329-a77c-da427e79fc39 0378-0060 HUMAN PRESCRIPTION DRUG Maprotiline Hydrochloride maprotiline hydrochloride TABLET, FILM COATED ORAL 19881003 ANDA ANDA072285 Mylan Pharmaceuticals Inc. MAPROTILINE HYDROCHLORIDE 25 mg/1 N 20181231 0378-0069_4250cbdf-0c7f-447c-9435-190a2c8c51e8 0378-0069 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 19970326 ANDA ANDA074461 Mylan Pharmaceuticals Inc. INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0378-0070_0eb4b0da-2c8a-417c-accf-3fc6a0a4aaad 0378-0070 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 19870717 ANDA ANDA071858 Mylan Pharmaceuticals Inc. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-0072_f030a2c7-4bb0-462b-b59a-7b4fbd140055 0378-0072 HUMAN PRESCRIPTION DRUG Clorpres clonidine hydrochloride and chlorthalidone TABLET ORAL 19980313 20180228 ANDA ANDA071325 Mylan Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE; CHLORTHALIDONE .3; 15 mg/1; mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0378-0073_2adf5b79-2f12-42d7-a4ac-910e7cb3ce71 0378-0073 HUMAN PRESCRIPTION DRUG Perphenazine and Amitriptyline Hydrochloride perphenazine and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19881110 ANDA ANDA071443 Mylan Pharmaceuticals Inc. PERPHENAZINE; AMITRIPTYLINE HYDROCHLORIDE 4; 50 mg/1; mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] N 20181231 0378-0076_12f38bfa-a67b-466f-bea0-32c11648eab6 0378-0076 HUMAN PRESCRIPTION DRUG Flurbiprofen flurbiprofen TABLET, FILM COATED ORAL 19940620 ANDA ANDA074358 Mylan Pharmaceuticals Inc. FLURBIPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-0078_56660a35-e86a-4eb1-bed4-9f7689182c67 0378-0078 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20110516 ANDA ANDA090324 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0378-0080_4250cbdf-0c7f-447c-9435-190a2c8c51e8 0378-0080 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 19960328 ANDA ANDA074461 Mylan Pharmaceuticals Inc. INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0378-0081_3f830175-e2d8-410d-b25a-49e4cc3c97e4 0378-0081 HUMAN PRESCRIPTION DRUG Captopril and Hydrochlorothiazide captopril and hydrochlorothiazide TABLET ORAL 19971229 ANDA ANDA074896 Mylan Phamaceuticals Inc. CAPTOPRIL; HYDROCHLOROTHIAZIDE 25; 15 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0378-0083_3f830175-e2d8-410d-b25a-49e4cc3c97e4 0378-0083 HUMAN PRESCRIPTION DRUG Captopril and Hydrochlorothiazide captopril and hydrochlorothiazide TABLET ORAL 19971229 ANDA ANDA074896 Mylan Phamaceuticals Inc. CAPTOPRIL; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0084_3f830175-e2d8-410d-b25a-49e4cc3c97e4 0378-0084 HUMAN PRESCRIPTION DRUG Captopril and Hydrochlorothiazide captopril and hydrochlorothiazide TABLET ORAL 19971229 ANDA ANDA074896 Mylan Phamaceuticals Inc. CAPTOPRIL; HYDROCHLOROTHIAZIDE 50; 15 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0085_56660a35-e86a-4eb1-bed4-9f7689182c67 0378-0085 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20110516 ANDA ANDA090324 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0378-0086_3f830175-e2d8-410d-b25a-49e4cc3c97e4 0378-0086 HUMAN PRESCRIPTION DRUG Captopril and Hydrochlorothiazide captopril and hydrochlorothiazide TABLET ORAL 19971229 ANDA ANDA074896 Mylan Phamaceuticals Inc. CAPTOPRIL; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0087_8ab0b141-aa2a-4329-a77c-da427e79fc39 0378-0087 HUMAN PRESCRIPTION DRUG Maprotiline Hydrochloride maprotiline hydrochloride TABLET, FILM COATED ORAL 19881003 ANDA ANDA072285 Mylan Pharmaceuticals Inc. MAPROTILINE HYDROCHLORIDE 50 mg/1 N 20181231 0378-0088_e5d31abe-2f73-4b5b-8c22-d6e0eea7f6c8 0378-0088 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 20000426 ANDA ANDA075091 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0378-0092_8ab0b141-aa2a-4329-a77c-da427e79fc39 0378-0092 HUMAN PRESCRIPTION DRUG Maprotiline Hydrochloride maprotiline hydrochloride TABLET, FILM COATED ORAL 19881003 ANDA ANDA072285 Mylan Pharmaceuticals Inc. MAPROTILINE HYDROCHLORIDE 75 mg/1 N 20181231 0378-0093_12f38bfa-a67b-466f-bea0-32c11648eab6 0378-0093 HUMAN PRESCRIPTION DRUG Flurbiprofen flurbiprofen TABLET, FILM COATED ORAL 19940620 ANDA ANDA074358 Mylan Pharmaceuticals Inc. FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-0094_e5d31abe-2f73-4b5b-8c22-d6e0eea7f6c8 0378-0094 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 19991006 ANDA ANDA075091 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0378-0127_b897829b-df47-4401-8a52-a8db8f2cfcf4 0378-0127 HUMAN PRESCRIPTION DRUG Pindolol pindolol TABLET ORAL 19920903 ANDA ANDA074019 Mylan Pharmaceuticals Inc. PINDOLOL 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0135_9dfb72a7-8a81-402c-959c-5e33f45d829c 0378-0135 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19920316 ANDA ANDA072838 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0378-0137_bc1ef0b4-9ca2-414b-9984-7c033fd54e09 0378-0137 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 19861024 ANDA ANDA018659 Mylan Pharmaceuticals Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0378-0141_c1a7f6b1-1c3c-4e35-bcb5-b97c0a9e6454 0378-0141 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide spironolactone and hydrochlorothiazide TABLET ORAL 20120726 20200229 ANDA ANDA086513 Mylan Pharmaceuticals Inc. SPIRONOLACTONE; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0143_a59d72eb-fca5-406b-82e7-9274490c3ef8 0378-0143 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 19840420 NDA NDA018858 Mylan Pharmaceuticals Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-0144_7c675b1a-0dd1-40e1-9db0-9101f30e544e 0378-0144 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20030220 ANDA ANDA074732 Mylan Pharmaceuticals Inc. TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20191231 0378-0145_e6f8afd5-9e4b-494f-89cc-9e8a75965e43 0378-0145 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxycycline CAPSULE ORAL 20140708 ANDA ANDA062337 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 0378-0147_a59d72eb-fca5-406b-82e7-9274490c3ef8 0378-0147 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 19840420 ANDA ANDA070624 Mylan Pharmaceuticals Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-0148_e6f8afd5-9e4b-494f-89cc-9e8a75965e43 0378-0148 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxycycline CAPSULE ORAL 20140709 ANDA ANDA062337 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0378-0150_41f85c2b-59e8-4afd-9e0c-e14692d5c727 0378-0150 HUMAN PRESCRIPTION DRUG Chlorothiazide chlorothiazide TABLET ORAL 19750626 ANDA ANDA084217 Mylan Pharmaceuticals Inc. CHLOROTHIAZIDE 250 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0152_6ef686c6-a01a-4040-b658-851c3ebccc9e 0378-0152 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 19870609 ANDA ANDA070317 Mylan Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-0156_f7f0c289-9fed-40e8-b9ca-d1281b1123d6 0378-0156 HUMAN PRESCRIPTION DRUG Probenecid probenecid TABLET, FILM COATED ORAL 19760113 ANDA ANDA084211 Mylan Pharmaceuticals Inc. PROBENECID 500 mg/1 N 20181231 0378-0160_47d25166-6e14-416f-89e0-0c53e9b45a49 0378-0160 HUMAN PRESCRIPTION DRUG Methyclothiazide methyclothiazide TABLET ORAL 19820817 ANDA ANDA087672 Mylan Pharmaceuticals Inc. METHYCLOTHIAZIDE 5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0162_41f85c2b-59e8-4afd-9e0c-e14692d5c727 0378-0162 HUMAN PRESCRIPTION DRUG Chlorothiazide chlorothiazide TABLET ORAL 19750717 ANDA ANDA084217 Mylan Pharmaceuticals Inc. CHLOROTHIAZIDE 500 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0167_e6f8afd5-9e4b-494f-89cc-9e8a75965e43 0378-0167 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxycycline TABLET ORAL 20140626 ANDA ANDA062432 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0378-0181_bc1ef0b4-9ca2-414b-9984-7c033fd54e09 0378-0181 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 19861024 ANDA ANDA018659 Mylan Pharmaceuticals Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0378-0182_d4e7134d-a35c-450d-a9d6-ce196ee14cf0 0378-0182 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0183_d4e7134d-a35c-450d-a9d6-ce196ee14cf0 0378-0183 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0184_d4e7134d-a35c-450d-a9d6-ce196ee14cf0 0378-0184 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0185_d4e7134d-a35c-450d-a9d6-ce196ee14cf0 0378-0185 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0186_6ef686c6-a01a-4040-b658-851c3ebccc9e 0378-0186 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 19870609 ANDA ANDA070317 Mylan Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-0187_d4e7134d-a35c-450d-a9d6-ce196ee14cf0 0378-0187 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0197_1386c897-5231-4464-9f83-935f8ccc17b0 0378-0197 HUMAN PRESCRIPTION DRUG Chlorpropamide chlorpropamide TABLET ORAL 19840601 ANDA ANDA088549 Mylan Pharmaceuticals Inc. CHLORPROPAMIDE 100 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-0199_6ef686c6-a01a-4040-b658-851c3ebccc9e 0378-0199 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 19870609 ANDA ANDA070317 Mylan Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-0208_e6f020dc-e4f8-424b-a715-644318de00fe 0378-0208 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19810827 NDA NDA018487 Mylan Pharmaceuticals Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0378-0210_1386c897-5231-4464-9f83-935f8ccc17b0 0378-0210 HUMAN PRESCRIPTION DRUG Chlorpropamide chlorpropamide TABLET ORAL 19840601 ANDA ANDA088549 Mylan Pharmaceuticals Inc. CHLORPROPAMIDE 250 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-0211_aaaf67c6-e6c7-410e-81ed-0cfe2544d711 0378-0211 HUMAN PRESCRIPTION DRUG Chlordiazepoxide and Amitriptyline Hydrochloride chlordiazepoxide and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19861210 ANDA ANDA071297 Mylan Pharmaceuticals Inc. CHLORDIAZEPOXIDE; AMITRIPTYLINE HYDROCHLORIDE 5; 14 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] CIV N 20181231 0378-0213_45a7d068-02db-42d8-b1f6-7daab6a4c397 0378-0213 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 19810226 ANDA ANDA086831 Mylan Pharmaceuticals Inc. CHLORTHALIDONE 50 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0378-0214_e7ea6040-082b-4bc2-bf23-49b9dd276bf8 0378-0214 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 Mylan Pharmaceuticals Inc. HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] N 20181231 0378-0215_5a786fe8-94d5-460a-9bd5-4d5271f9b2e0 0378-0215 HUMAN PRESCRIPTION DRUG Tolbutamide tolbutamide TABLET ORAL 19891101 ANDA ANDA086445 Mylan Pharmaceuticals Inc. TOLBUTAMIDE 500 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-0216_e6f020dc-e4f8-424b-a715-644318de00fe 0378-0216 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19810827 NDA NDA018487 Mylan Pharmaceuticals Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0378-0217_e55c3303-e629-490e-b2f7-650b99099e74 0378-0217 HUMAN PRESCRIPTION DRUG Tolazamide tolazamide TABLET ORAL 20130118 ANDA ANDA070259 Mylan Pharmaceuticals Inc. TOLAZAMIDE 250 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-0218_9490c5a5-bbf7-4ee7-9615-9d94f9f51029 0378-0218 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 19990617 ANDA ANDA073457 Mylan Pharmaceuticals Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0221_cb884a5e-bc13-43d8-9b2f-f3ee50db896c 0378-0221 HUMAN PRESCRIPTION DRUG Timolol Maleate timolol maleate TABLET ORAL 19900608 ANDA ANDA072668 Mylan Pharmaceuticals Inc. TIMOLOL MALEATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0222_45a7d068-02db-42d8-b1f6-7daab6a4c397 0378-0222 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 19810226 ANDA ANDA086831 Mylan Pharmaceuticals Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0378-0228_dd02831e-108a-44be-abde-e6cb658a6c16 0378-0228 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 ANDA ANDA076801 Mylan Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 0378-0231_9490c5a5-bbf7-4ee7-9615-9d94f9f51029 0378-0231 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 19920124 ANDA ANDA073457 Mylan Pharmaceuticals Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0232_e6f020dc-e4f8-424b-a715-644318de00fe 0378-0232 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19861029 ANDA ANDA070082 Mylan Pharmaceuticals Inc. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0378-0243_58035cf5-f25a-4e9b-92ba-e4f8622822aa 0378-0243 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20020122 ANDA ANDA040424 Mylan Pharmaceuticals Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0378-0255_7439aed5-77bd-45d8-aaba-7ea4ea721b5e 0378-0255 HUMAN PRESCRIPTION DRUG Albuterol albuterol sulfate TABLET ORAL 19910117 ANDA ANDA072894 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0378-0257_e7ea6040-082b-4bc2-bf23-49b9dd276bf8 0378-0257 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 Mylan Pharmaceuticals Inc. HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] N 20181231 0378-0261_2d2a4c1f-6cdb-48e2-b549-f6838ef8ba9e 0378-0261 HUMAN PRESCRIPTION DRUG Ketoconazole ketoconazole TABLET ORAL 20000223 ANDA ANDA075597 Mylan Pharmaceuticals Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-0271_47822069-8209-466e-81f9-6eb395be2c1c 0378-0271 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 19850904 ANDA ANDA070325 Mylan Pharmaceuticals Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-0274_7c675b1a-0dd1-40e1-9db0-9101f30e544e 0378-0274 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20030220 ANDA ANDA074732 Mylan Pharmaceuticals Inc. TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20191231 0378-0277_aaaf67c6-e6c7-410e-81ed-0cfe2544d711 0378-0277 HUMAN PRESCRIPTION DRUG Chlordiazepoxide and Amitriptyline Hydrochloride chlordiazepoxide and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19861210 ANDA ANDA071297 Mylan Pharmaceuticals Inc. CHLORDIAZEPOXIDE; AMITRIPTYLINE HYDROCHLORIDE 10; 27.98 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] CIV N 20181231 0378-0313_4954846c-9d3f-47d1-808b-b3fe20489485 0378-0313 HUMAN PRESCRIPTION DRUG Tolmetin Sodium tolmetin sodium TABLET, FILM COATED ORAL 19940830 ANDA ANDA074473 Mylan Pharmaceuticals Inc. TOLMETIN SODIUM 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-0315_1801f084-0e3b-4865-911e-bc36dbafa97e 0378-0315 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA076930 Mylan Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0378-0317_f45db833-cec2-45d8-8b5f-ca1e820b8f48 0378-0317 HUMAN PRESCRIPTION DRUG Cimetidine cimetidine TABLET, FILM COATED ORAL 19940517 ANDA ANDA074246 Mylan Pharmaceuticals Inc. CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0378-0318_dd02831e-108a-44be-abde-e6cb658a6c16 0378-0318 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 ANDA ANDA076801 Mylan Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 0378-0327_e7ea6040-082b-4bc2-bf23-49b9dd276bf8 0378-0327 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 Mylan Pharmaceuticals Inc. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 0378-0330_2adf5b79-2f12-42d7-a4ac-910e7cb3ce71 0378-0330 HUMAN PRESCRIPTION DRUG Perphenazine and Amitriptyline Hydrochloride perphenazine and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19881110 ANDA ANDA071443 Mylan Pharmaceuticals Inc. PERPHENAZINE; AMITRIPTYLINE HYDROCHLORIDE 2; 10 mg/1; mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] N 20181231 0378-0334_e7ea6040-082b-4bc2-bf23-49b9dd276bf8 0378-0334 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20090717 ANDA ANDA070278 Mylan Pharmaceuticals Inc. HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] N 20181231 0378-0335_e7ea6040-082b-4bc2-bf23-49b9dd276bf8 0378-0335 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20090717 ANDA ANDA070278 Mylan Pharmaceuticals Inc. HALOPERIDOL 20 mg/1 Typical Antipsychotic [EPC] N 20181231 0378-0340_98926aa8-f268-4920-a066-01950f0931fe 0378-0340 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150519 ANDA ANDA202298 Mylan Pharmaceuticals Inc. GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-0342_98926aa8-f268-4920-a066-01950f0931fe 0378-0342 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150519 ANDA ANDA202298 Mylan Pharmaceuticals Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-0344_1801f084-0e3b-4865-911e-bc36dbafa97e 0378-0344 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA076930 Mylan Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0378-0345_47822069-8209-466e-81f9-6eb395be2c1c 0378-0345 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 19850904 ANDA ANDA070325 Mylan Pharmaceuticals Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-0347_fa0d6a3f-e297-45e5-ad1f-f08787db0227 0378-0347 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride and Hydrochlorothiazide propranolol hydrochloride and hydrochlorothiazide TABLET ORAL 19870401 ANDA ANDA070947 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 80; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0351_e7ea6040-082b-4bc2-bf23-49b9dd276bf8 0378-0351 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 Mylan Pharmaceuticals Inc. HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] N 20181231 0378-0353_c5b143fb-b562-4c03-a08d-b8fdde900776 0378-0353 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA201071 Mylan Pharmaceuticals Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-0355_32dce51a-1b47-48fe-9c79-7e761e9e2eb4 0378-0355 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020215 ANDA ANDA076152 Mylan Pharmaceuticals Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-0357_bded7f93-7028-43a5-a0bc-822a1a11763a 0378-0357 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970708 ANDA ANDA074425 Mylan Pharmaceuticals Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 0378-0360_c5b143fb-b562-4c03-a08d-b8fdde900776 0378-0360 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA201071 Mylan Pharmaceuticals Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-0372_f45db833-cec2-45d8-8b5f-ca1e820b8f48 0378-0372 HUMAN PRESCRIPTION DRUG Cimetidine cimetidine TABLET, FILM COATED ORAL 19940517 ANDA ANDA074246 Mylan Pharmaceuticals Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0378-0373_5c84f572-266f-46fd-858e-1863952806b9 0378-0373 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ENTERAL 19980618 ANDA ANDA040274 Mylan Pharmaceuticals Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 0378-0390_c5b143fb-b562-4c03-a08d-b8fdde900776 0378-0390 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA201071 Mylan Pharmaceuticals Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-0403_0c8c973f-13a2-4883-8316-4006398e2931 0378-0403 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide spironolactone and hydrochlorothiazide TABLET ORAL 20170331 ANDA ANDA086513 Mylan Pharmaceuticals Inc. SPIRONOLACTONE; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0407_4e16abbd-25cf-4a9d-a653-2d179c2a3616 0378-0407 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20001220 ANDA ANDA075889 Mylan Pharmaceuticals Inc. FLUVOXAMINE MALEATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-0412_4e16abbd-25cf-4a9d-a653-2d179c2a3616 0378-0412 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20001220 ANDA ANDA075889 Mylan Pharmaceuticals Inc. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-0414_4e16abbd-25cf-4a9d-a653-2d179c2a3616 0378-0414 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20001220 ANDA ANDA075889 Mylan Pharmaceuticals Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-0415_13ca192c-5f66-48de-bb33-6d0963d36564 0378-0415 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 Mylan Pharmaceuticals Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 0378-0421_052afe2d-f46c-495c-b4ac-71879e20766c 0378-0421 HUMAN PRESCRIPTION DRUG Methyldopa methyldopa TABLET ORAL 19850418 ANDA ANDA070076 Mylan Pharmaceuticals Inc. METHYLDOPA 500 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-0424_900f9d6a-89c9-4884-a56e-51a127b19f4a 0378-0424 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide metoprolol tartrate and hydrochlorothiazide TABLET ORAL 20040820 ANDA ANDA076792 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0427_8b546507-d63f-47c6-b0b3-24d854c03583 0378-0427 HUMAN PRESCRIPTION DRUG Sulindac sulindac TABLET ORAL 19930622 ANDA ANDA073039 Mylan Pharmaceuticals Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-0431_98926aa8-f268-4920-a066-01950f0931fe 0378-0431 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150519 ANDA ANDA202298 Mylan Pharmaceuticals Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-0433_ccee4b15-63f1-4891-8fe0-b7e2b252c010 0378-0433 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000511 ANDA ANDA075491 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0378-0434_900f9d6a-89c9-4884-a56e-51a127b19f4a 0378-0434 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide metoprolol tartrate and hydrochlorothiazide TABLET ORAL 20040820 ANDA ANDA076792 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0435_ccee4b15-63f1-4891-8fe0-b7e2b252c010 0378-0435 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000511 ANDA ANDA075491 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0378-0437_58035cf5-f25a-4e9b-92ba-e4f8622822aa 0378-0437 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20020122 ANDA ANDA040424 Mylan Pharmaceuticals Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0378-0441_afe4bc8f-96fb-4f63-90ce-f08937eabff7 0378-0441 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076430 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-0442_2adf5b79-2f12-42d7-a4ac-910e7cb3ce71 0378-0442 HUMAN PRESCRIPTION DRUG Perphenazine and Amitriptyline Hydrochloride perphenazine and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19881110 ANDA ANDA071443 Mylan Pharmaceuticals Inc. PERPHENAZINE; AMITRIPTYLINE HYDROCHLORIDE 2; 25 mg/1; mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] N 20181231 0378-0443_afe4bc8f-96fb-4f63-90ce-f08937eabff7 0378-0443 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076430 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-0444_afe4bc8f-96fb-4f63-90ce-f08937eabff7 0378-0444 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076430 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-0445_900f9d6a-89c9-4884-a56e-51a127b19f4a 0378-0445 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide metoprolol tartrate and hydrochlorothiazide TABLET ORAL 20040820 ANDA ANDA076792 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 100; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0447_afe4bc8f-96fb-4f63-90ce-f08937eabff7 0378-0447 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076430 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-0460_0c2fa412-6689-48d7-917b-5c513a657f71 0378-0460 HUMAN PRESCRIPTION DRUG MAXZIDE maxzide TABLET ORAL 19880513 NDA NDA019129 Mylan Pharmaceuticals Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0464_0c2fa412-6689-48d7-917b-5c513a657f71 0378-0464 HUMAN PRESCRIPTION DRUG MAXZIDE-25 maxzide TABLET ORAL 19880513 NDA NDA019129 Mylan Pharmaceuticals Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0466_46a2db77-444a-4175-84ef-da4c859db817 0378-0466 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20160930 ANDA ANDA074116 Mylan Pharmaceuticals Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-0467_46a2db77-444a-4175-84ef-da4c859db817 0378-0467 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20160930 ANDA ANDA074118 Mylan Pharmaceuticals Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-0471_96ec9b07-f16b-48be-9ddb-0687c287c38e 0378-0471 HUMAN PRESCRIPTION DRUG Fenoprofen Calcium Fenoprofen Calcium TABLET, FILM COATED ORAL 20121114 ANDA ANDA072267 Mylan Pharmaceuticals Inc. FENOPROFEN CALCIUM 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-0472_97feafb3-df9c-49fa-af84-6438a44d6d44 0378-0472 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090129 ANDA ANDA077567 Mylan Pharmaceuticals Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 0378-0473_97feafb3-df9c-49fa-af84-6438a44d6d44 0378-0473 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090202 ANDA ANDA077567 Mylan Pharmaceuticals Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 0378-0477_47822069-8209-466e-81f9-6eb395be2c1c 0378-0477 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 19850904 ANDA ANDA070325 Mylan Pharmaceuticals Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-0480_1db73f94-fdd5-403e-ac14-cb42269f8190 0378-0480 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000314 ANDA ANDA090649 Mylan Pharmaceuticals Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-0481_1db73f94-fdd5-403e-ac14-cb42269f8190 0378-0481 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000314 ANDA ANDA090649 Mylan Pharmaceuticals Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-0486_1f2a4716-34fe-4a2c-8bbf-5ed16772a967 0378-0486 HUMAN PRESCRIPTION DRUG Theophylline (Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20170307 ANDA ANDA040560 Mylan Pharamceuticals Inc. THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0378-0487_1f2a4716-34fe-4a2c-8bbf-5ed16772a967 0378-0487 HUMAN PRESCRIPTION DRUG Theophylline (Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20170307 ANDA ANDA040560 Mylan Pharamceuticals Inc. THEOPHYLLINE ANHYDROUS 600 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0378-0494_1db73f94-fdd5-403e-ac14-cb42269f8190 0378-0494 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000314 ANDA ANDA090649 Mylan Pharmaceuticals Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-0501_fe98646b-ed32-4db4-8ef7-f0fda4ecd4db 0378-0501 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20000925 ANDA ANDA075768 Mylan Pharmaceuticals Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0503_fe98646b-ed32-4db4-8ef7-f0fda4ecd4db 0378-0503 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20000925 ANDA ANDA075768 Mylan Pharmaceuticals Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0505_fe98646b-ed32-4db4-8ef7-f0fda4ecd4db 0378-0505 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20000925 ANDA ANDA075768 Mylan Pharmaceuticals Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0507_939cd970-6d0d-4403-a7fa-21a2b87555df 0378-0507 HUMAN PRESCRIPTION DRUG Methyldopa and Hydrochlorothiazide methyldopa and hydrochlorothiazide TABLET ORAL 19860123 ANDA ANDA070265 Mylan Pharmaceuticals Inc. METHYLDOPA; HYDROCHLOROTHIAZIDE 250; 15 mg/1; mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0512_9e38fa7f-fb48-46a2-9222-7cede5a349a3 0378-0512 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED ORAL 20091228 ANDA ANDA071483 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-0523_04392b3e-3ca2-44b9-9efa-b37a7ca48243 0378-0523 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate bisoprolol fumarate TABLET, FILM COATED ORAL 20120924 ANDA ANDA075831 Mylan Pharmaceuticals Inc. BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 0378-0524_04392b3e-3ca2-44b9-9efa-b37a7ca48243 0378-0524 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate bisoprolol fumarate TABLET, FILM COATED ORAL 20120924 ANDA ANDA075831 Mylan Pharmaceuticals Inc. BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 0378-0525_9dfb72a7-8a81-402c-959c-5e33f45d829c 0378-0525 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19920316 ANDA ANDA072838 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0378-0531_8b546507-d63f-47c6-b0b3-24d854c03583 0378-0531 HUMAN PRESCRIPTION DRUG Sulindac sulindac TABLET ORAL 19930622 ANDA ANDA073039 Mylan Pharmaceuticals Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-0541_f45db833-cec2-45d8-8b5f-ca1e820b8f48 0378-0541 HUMAN PRESCRIPTION DRUG Cimetidine cimetidine TABLET, FILM COATED ORAL 19940517 ANDA ANDA074246 Mylan Pharmaceuticals Inc. CIMETIDINE 800 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0378-0551_e55c3303-e629-490e-b2f7-650b99099e74 0378-0551 HUMAN PRESCRIPTION DRUG Tolazamide tolazamide TABLET ORAL 20130118 ANDA ANDA070259 Mylan Pharmaceuticals Inc. TOLAZAMIDE 500 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-0572_7439aed5-77bd-45d8-aaba-7ea4ea721b5e 0378-0572 HUMAN PRESCRIPTION DRUG Albuterol albuterol sulfate TABLET ORAL 19910117 ANDA ANDA072894 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0378-0574_2adf5b79-2f12-42d7-a4ac-910e7cb3ce71 0378-0574 HUMAN PRESCRIPTION DRUG Perphenazine and Amitriptyline Hydrochloride perphenazine and amitriptyline hydrochloride TABLET, FILM COATED ORAL 19881110 ANDA ANDA071443 Mylan Pharmaceuticals Inc. PERPHENAZINE; AMITRIPTYLINE HYDROCHLORIDE 4; 25 mg/1; mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] N 20181231 0378-0577_bc568ed8-6312-4d66-9ea5-80ca9424343e 0378-0577 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride and Hydrochlorothiazide amiloride hydrochloride and hydrochlorothiazide TABLET ORAL 19911031 ANDA ANDA073209 Mylan Pharmaceuticals Inc. AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0611_052afe2d-f46c-495c-b4ac-71879e20766c 0378-0611 HUMAN PRESCRIPTION DRUG Methyldopa methyldopa TABLET ORAL 19850418 ANDA ANDA070076 Mylan Pharmaceuticals Inc. METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-0612_4527699e-346e-4aaa-9484-a9c9c4205588 0378-0612 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 19830315 ANDA ANDA088004 Mylan Pharmaceuticals Inc. THIORIDAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-0614_4527699e-346e-4aaa-9484-a9c9c4205588 0378-0614 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 19830315 ANDA ANDA088004 Mylan Pharmaceuticals Inc. THIORIDAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-0616_4527699e-346e-4aaa-9484-a9c9c4205588 0378-0616 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 19830315 ANDA ANDA088004 Mylan Pharmaceuticals Inc. THIORIDAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-0618_4527699e-346e-4aaa-9484-a9c9c4205588 0378-0618 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 19831118 ANDA ANDA088004 Mylan Pharmaceuticals Inc. THIORIDAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-0630_9e1900e4-eae1-4295-826c-d598e3486e5a 0378-0630 HUMAN PRESCRIPTION DRUG Iloperidone Iloperidone TABLET ORAL 20170320 ANDA ANDA207231 Mylan Pharmaceuticals Inc. ILOPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-0631_9e1900e4-eae1-4295-826c-d598e3486e5a 0378-0631 HUMAN PRESCRIPTION DRUG Iloperidone Iloperidone TABLET ORAL 20170320 ANDA ANDA207231 Mylan Pharmaceuticals Inc. ILOPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-0632_9e1900e4-eae1-4295-826c-d598e3486e5a 0378-0632 HUMAN PRESCRIPTION DRUG Iloperidone Iloperidone TABLET ORAL 20170320 ANDA ANDA207231 Mylan Pharmaceuticals Inc. ILOPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-0633_9e1900e4-eae1-4295-826c-d598e3486e5a 0378-0633 HUMAN PRESCRIPTION DRUG Iloperidone Iloperidone TABLET ORAL 20170320 ANDA ANDA207231 Mylan Pharmaceuticals Inc. ILOPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-0634_9e1900e4-eae1-4295-826c-d598e3486e5a 0378-0634 HUMAN PRESCRIPTION DRUG Iloperidone Iloperidone TABLET ORAL 20170320 ANDA ANDA207231 Mylan Pharmaceuticals Inc. ILOPERIDONE 8 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-0635_9e1900e4-eae1-4295-826c-d598e3486e5a 0378-0635 HUMAN PRESCRIPTION DRUG Iloperidone Iloperidone TABLET ORAL 20170320 ANDA ANDA207231 Mylan Pharmaceuticals Inc. ILOPERIDONE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-0636_9e1900e4-eae1-4295-826c-d598e3486e5a 0378-0636 HUMAN PRESCRIPTION DRUG Iloperidone Iloperidone TABLET ORAL 20170320 ANDA ANDA207231 Mylan Pharmaceuticals Inc. ILOPERIDONE 12 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-0711_939cd970-6d0d-4403-a7fa-21a2b87555df 0378-0711 HUMAN PRESCRIPTION DRUG Methyldopa and Hydrochlorothiazide methyldopa and hydrochlorothiazide TABLET ORAL 19860123 ANDA ANDA070265 Mylan Pharmaceuticals Inc. METHYLDOPA; HYDROCHLOROTHIAZIDE 250; 25 mg/1; mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0712_fc29bbe8-c7db-4343-90af-88d68e408901 0378-0712 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide enalapril maleate and hydrochlorothiazide TABLET ORAL 20010919 ANDA ANDA075624 Mylan Pharmaceuticals Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0715_cb884a5e-bc13-43d8-9b2f-f3ee50db896c 0378-0715 HUMAN PRESCRIPTION DRUG Timolol Maleate timolol maleate TABLET ORAL 19900608 ANDA ANDA072668 Mylan Pharmaceuticals Inc. TIMOLOL MALEATE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0722_3f2c9c8c-06af-422f-b456-54531c88501b 0378-0722 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20030506 ANDA ANDA076354 Mylan Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-0723_fc29bbe8-c7db-4343-90af-88d68e408901 0378-0723 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide enalapril maleate and hydrochlorothiazide TABLET ORAL 20010919 ANDA ANDA075624 Mylan Pharmaceuticals Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0724_3f2c9c8c-06af-422f-b456-54531c88501b 0378-0724 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20030506 ANDA ANDA076354 Mylan Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-0731_fa0d6a3f-e297-45e5-ad1f-f08787db0227 0378-0731 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride and Hydrochlorothiazide propranolol hydrochloride and hydrochlorothiazide TABLET ORAL 19870304 ANDA ANDA070947 Mylan Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0734_820affcf-5f5e-4267-ac44-597cd1276a7e 0378-0734 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine TABLET, FILM COATED ORAL 20131223 ANDA ANDA075755 Mylan Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-0735_820affcf-5f5e-4267-ac44-597cd1276a7e 0378-0735 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine TABLET, FILM COATED ORAL 20131223 ANDA ANDA075755 Mylan Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-0751_abd9169a-7b62-4d64-9aa4-e9b007fc4b1d 0378-0751 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 19910530 ANDA ANDA073144 Mylan Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0378-0757_9490c5a5-bbf7-4ee7-9615-9d94f9f51029 0378-0757 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 19920124 ANDA ANDA073457 Mylan Pharmaceuticals Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-0761_abd9169a-7b62-4d64-9aa4-e9b007fc4b1d 0378-0761 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20130424 ANDA ANDA073144 Mylan Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0378-0771_abd9169a-7b62-4d64-9aa4-e9b007fc4b1d 0378-0771 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20060203 ANDA ANDA073144 Mylan Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0378-0772_9e38fa7f-fb48-46a2-9222-7cede5a349a3 0378-0772 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED ORAL 19890215 ANDA ANDA071483 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-0781_57066b1f-65bb-428b-9c5b-ae88d15c6acf 0378-0781 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine TABLET, FILM COATED ORAL 20110825 ANDA ANDA077081 Mylan Pharmaceuticals Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 0378-0782_57066b1f-65bb-428b-9c5b-ae88d15c6acf 0378-0782 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine TABLET, FILM COATED ORAL 20110825 ANDA ANDA077081 Mylan Pharmaceuticals Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 0378-0810_c5b422d3-3207-4489-9b1d-527dd89f4667 0378-0810 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20000207 ANDA ANDA075640 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-0825_cfaa0d0b-602c-4411-bba7-be0073ba99ea 0378-0825 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 19990708 ANDA ANDA075417 Mylan Pharmaceuticals Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-0830_1dd21a75-ff42-4ad5-9eab-9ec129c59a3e 0378-0830 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20160602 20180331 ANDA ANDA065064 Mylan Pharmaceuticals Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0378-0831_1dd21a75-ff42-4ad5-9eab-9ec129c59a3e 0378-0831 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20160602 20180430 ANDA ANDA065063 Mylan Pharmaceuticals Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0378-0832_fb0d7e43-d00f-49b4-b689-5aa647e0672a 0378-0832 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20160602 20180228 ANDA ANDA065093 Mylan Pharmaceuticals Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0378-0835_79964d5c-9117-4912-8e6a-bf68a84eca06 0378-0835 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20160610 20180228 ANDA ANDA065358 Mylan Pharmaceuticals Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0378-0836_a4aab143-7a65-4965-8e4f-a4c6f8ccf18b 0378-0836 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20160610 20180430 ANDA ANDA065098 Mylan Pharmaceuticals Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0378-0860_cfaa0d0b-602c-4411-bba7-be0073ba99ea 0378-0860 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 19990708 ANDA ANDA075417 Mylan Pharmaceuticals Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-0871_017e8de4-474d-42cb-b8ef-a6b1577ae995 0378-0871 HUMAN PRESCRIPTION DRUG Clonidine clonidine PATCH TRANSDERMAL 20130208 ANDA ANDA076166 Mylan Pharmaceuticals Inc. CLONIDINE .1 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-0872_017e8de4-474d-42cb-b8ef-a6b1577ae995 0378-0872 HUMAN PRESCRIPTION DRUG Clonidine clonidine PATCH TRANSDERMAL 20130208 ANDA ANDA076166 Mylan Pharmaceuticals Inc. CLONIDINE .2 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-0873_017e8de4-474d-42cb-b8ef-a6b1577ae995 0378-0873 HUMAN PRESCRIPTION DRUG Clonidine clonidine PATCH TRANSDERMAL 20130208 ANDA ANDA076166 Mylan Pharmaceuticals Inc. CLONIDINE .3 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-0923_851b6cdb-4be1-4b33-84e6-1e7af5fcd1aa 0378-0923 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Sublingual buprenorphine hydrochloride sublingual TABLET SUBLINGUAL 20150306 ANDA ANDA201066 Mylan Pharmaceuticals Inc. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 0378-0924_851b6cdb-4be1-4b33-84e6-1e7af5fcd1aa 0378-0924 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Sublingual buprenorphine hydrochloride sublingual TABLET SUBLINGUAL 20150306 ANDA ANDA201066 Mylan Pharmaceuticals Inc. BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 0378-0972_cfaa0d0b-602c-4411-bba7-be0073ba99ea 0378-0972 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 20100420 ANDA ANDA075417 Mylan Pharmaceuticals Inc. CLOZAPINE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-0973_cfaa0d0b-602c-4411-bba7-be0073ba99ea 0378-0973 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 20100420 ANDA ANDA075417 Mylan Pharmaceuticals Inc. CLOZAPINE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-1001_942272de-0dad-4718-bdce-b745dff16e9e 0378-1001 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19870623 ANDA ANDA071093 Mylan Pharmaceuticals Inc. THIOTHIXENE 1 mg/1 Typical Antipsychotic [EPC] N 20181231 0378-1005_afda53e1-de44-4125-8f00-8f8e3b3f0220 0378-1005 HUMAN PRESCRIPTION DRUG Azathioprine azathioprine TABLET ORAL 20091228 ANDA ANDA075568 Mylan Pharmaceuticals Inc. AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 0378-1012_8d0a4642-f635-4781-b6e9-ae08bed99b96 0378-1012 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20140904 ANDA ANDA076113 Mylan Pharmaceuticals Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-1020_4fa78e79-6bda-4fe6-ad6f-319afb539744 0378-1020 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride nicardipine hydrochloride CAPSULE ORAL 19960719 ANDA ANDA074642 Mylan Pharmaceuticals Inc. NICARDIPINE HYDROCHLORIDE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0378-1025_a1b7b500-dd04-4ae5-96cf-474a450c8f7d 0378-1025 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20151211 ANDA ANDA202656 Mylan Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0378-1030_a3f4afdc-0620-4899-ab4f-168fbfa446a8 0378-1030 HUMAN PRESCRIPTION DRUG Eplerenone eplerenone TABLET, FILM COATED ORAL 20171003 ANDA ANDA203896 Mylan Pharmaceuticals Inc. EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0378-1031_a3f4afdc-0620-4899-ab4f-168fbfa446a8 0378-1031 HUMAN PRESCRIPTION DRUG Eplerenone eplerenone TABLET, FILM COATED ORAL 20171003 ANDA ANDA203896 Mylan Pharmaceuticals Inc. EPLERENONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0378-1049_573022de-0245-4b68-8341-c3ebf11031cb 0378-1049 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Mylan Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20191231 0378-1051_5568a4ba-14d6-4f09-80f8-e71409c5d315 0378-1051 HUMAN PRESCRIPTION DRUG Enalapril Maleate enalapril maleate TABLET ORAL 20000822 ANDA ANDA075480 Mylan Pharmaceuticals Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-1052_5568a4ba-14d6-4f09-80f8-e71409c5d315 0378-1052 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000822 ANDA ANDA075480 Mylan Pharmaceuticals Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-1053_5568a4ba-14d6-4f09-80f8-e71409c5d315 0378-1053 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000822 ANDA ANDA075480 Mylan Pharmaceuticals Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-1054_5568a4ba-14d6-4f09-80f8-e71409c5d315 0378-1054 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000822 ANDA ANDA075480 Mylan Pharmaceuticals Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-1061_7be16328-fb16-46fb-9449-ccff32ebe86b 0378-1061 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride guanfacine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150602 ANDA ANDA202578 Mylan Pharmaceuticals Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-1062_7be16328-fb16-46fb-9449-ccff32ebe86b 0378-1062 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride guanfacine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150602 ANDA ANDA202578 Mylan Pharmaceuticals Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-1063_7be16328-fb16-46fb-9449-ccff32ebe86b 0378-1063 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride guanfacine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150602 ANDA ANDA202578 Mylan Pharmaceuticals Inc. GUANFACINE HYDROCHLORIDE 3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-1065_7be16328-fb16-46fb-9449-ccff32ebe86b 0378-1065 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride guanfacine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150602 ANDA ANDA202578 Mylan Pharmaceuticals Inc. GUANFACINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-1070_3ed54a71-2e00-46ad-9ba0-21f7516a41fa 0378-1070 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine CAPSULE, EXTENDED RELEASE ORAL 20160720 ANDA ANDA206735 Mylan Pharmaceuticals Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-1071_3ed54a71-2e00-46ad-9ba0-21f7516a41fa 0378-1071 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine CAPSULE, EXTENDED RELEASE ORAL 20160720 ANDA ANDA206735 Mylan Pharmaceuticals Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-1072_3ed54a71-2e00-46ad-9ba0-21f7516a41fa 0378-1072 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine CAPSULE, EXTENDED RELEASE ORAL 20160720 ANDA ANDA206735 Mylan Pharmaceuticals Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-1075_db72c3a6-976f-4546-8705-86bb96902842 0378-1075 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine telmisartan and amlodipine TABLET ORAL 20140919 ANDA ANDA202516 Mylan Pharmaceuticals Inc. TELMISARTAN; AMLODIPINE BESYLATE 40; 5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-1076_db72c3a6-976f-4546-8705-86bb96902842 0378-1076 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine telmisartan and amlodipine TABLET ORAL 20140919 ANDA ANDA202516 Mylan Pharmaceuticals Inc. TELMISARTAN; AMLODIPINE BESYLATE 40; 10 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-1077_db72c3a6-976f-4546-8705-86bb96902842 0378-1077 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine telmisartan and amlodipine TABLET ORAL 20140919 ANDA ANDA202516 Mylan Pharmaceuticals Inc. TELMISARTAN; AMLODIPINE BESYLATE 80; 5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-1078_db72c3a6-976f-4546-8705-86bb96902842 0378-1078 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine telmisartan and amlodipine TABLET ORAL 20140919 ANDA ANDA202516 Mylan Pharmaceuticals Inc. TELMISARTAN; AMLODIPINE BESYLATE 80; 10 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-1101_fc3761eb-16d8-4c67-bc71-5436c393efac 0378-1101 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19890228 ANDA ANDA072575 Mylan Pharmaceuticals Inc. PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-1103_be032f1e-c123-45a0-a345-a56be6fa43a6 0378-1103 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine TABLET ORAL 20150711 ANDA ANDA079225 Mylan Pharmaceuticals Inc. MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0378-1104_be032f1e-c123-45a0-a345-a56be6fa43a6 0378-1104 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine TABLET ORAL 20150711 ANDA ANDA079225 Mylan Pharmaceuticals Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0378-1105_a5456831-c5fa-4273-9144-8a49a5650cd1 0378-1105 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 19940510 ANDA ANDA074226 Mylan Pharmaceuticals Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-1110_a5456831-c5fa-4273-9144-8a49a5650cd1 0378-1110 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 19940510 ANDA ANDA074226 Mylan Pharmaceuticals Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-1113_a0deca4a-86db-4825-b5b9-37e3ed7a7ddd 0378-1113 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19990917 ANDA ANDA074792 Mylan Pharmaceuticals Inc. GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-1125_a0deca4a-86db-4825-b5b9-37e3ed7a7ddd 0378-1125 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19990917 ANDA ANDA074792 Mylan Pharmaceuticals Inc. GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-1132_af74832c-d5c4-4c96-ad1c-5f6c228f09ce 0378-1132 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 19931031 ANDA ANDA074172 Mylan Pharmaceuticals Inc. NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-1133_56660a35-e86a-4eb1-bed4-9f7689182c67 0378-1133 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20110516 ANDA ANDA090324 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0378-1134_b442477a-48ad-4e2b-9c14-2db7375f02a2 0378-1134 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20130516 ANDA ANDA074761 Mylan Pharmaceuticals Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0378-1140_4af9659d-c8ff-4a91-9db8-ea91fc736042 0378-1140 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020301 ANDA ANDA076008 Mylan Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 0378-1142_a0deca4a-86db-4825-b5b9-37e3ed7a7ddd 0378-1142 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19990917 ANDA ANDA074792 Mylan Pharmaceuticals Inc. GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-1145_4af9659d-c8ff-4a91-9db8-ea91fc736042 0378-1145 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20130708 ANDA ANDA076008 Mylan Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 7.5 mg/1 N 20181231 0378-1150_4af9659d-c8ff-4a91-9db8-ea91fc736042 0378-1150 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020301 ANDA ANDA076008 Mylan Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 0378-1160_12a428d9-d64e-412a-b9ec-60fe29ce15b4 0378-1160 HUMAN PRESCRIPTION DRUG Guanfacine guanfacine Hydrochloride TABLET ORAL 19970127 ANDA ANDA074796 Mylan Pharmaceuticals Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-1165_4af9659d-c8ff-4a91-9db8-ea91fc736042 0378-1165 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA076008 Mylan Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 0378-1171_af74832c-d5c4-4c96-ad1c-5f6c228f09ce 0378-1171 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 19931031 ANDA ANDA074172 Mylan Pharmaceuticals Inc. NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-1175_4af9659d-c8ff-4a91-9db8-ea91fc736042 0378-1175 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20010628 ANDA ANDA076008 Mylan Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 0378-1190_12a428d9-d64e-412a-b9ec-60fe29ce15b4 0378-1190 HUMAN PRESCRIPTION DRUG Guanfacine guanfacine Hydrochloride TABLET ORAL 19970127 ANDA ANDA074796 Mylan Pharmaceuticals Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0378-1200_a419d720-1686-40ba-bb56-a823aa9caa3a 0378-1200 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride acebutolol hydrochloride CAPSULE ORAL 19950424 ANDA ANDA074288 Mylan Pharmaceuticals Inc. ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-1258_33252974-23ce-40b7-9607-79220e063b90 0378-1258 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone CAPSULE, EXTENDED RELEASE ORAL 20160523 ANDA ANDA203803 Mylan Pharmaceuticals Inc. PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] N 20181231 0378-1259_33252974-23ce-40b7-9607-79220e063b90 0378-1259 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone CAPSULE, EXTENDED RELEASE ORAL 20160523 ANDA ANDA203803 Mylan Pharmaceuticals Inc. PROPAFENONE HYDROCHLORIDE 325 mg/1 Antiarrhythmic [EPC] N 20181231 0378-1261_33252974-23ce-40b7-9607-79220e063b90 0378-1261 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone CAPSULE, EXTENDED RELEASE ORAL 20160523 ANDA ANDA203803 Mylan Pharmaceuticals Inc. PROPAFENONE HYDROCHLORIDE 425 mg/1 Antiarrhythmic [EPC] N 20181231 0378-1270_45e010f2-7e6b-41f5-b043-727bbda2232e 0378-1270 HUMAN PRESCRIPTION DRUG Rasagiline Mesylate rasagiline mesylate TABLET ORAL 20170526 ANDA ANDA201971 Mylan Pharmaceuticals Inc. RASAGILINE MESYLATE .5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 0378-1271_45e010f2-7e6b-41f5-b043-727bbda2232e 0378-1271 HUMAN PRESCRIPTION DRUG Rasagiline Mesylate rasagiline mesylate TABLET ORAL 20170526 ANDA ANDA201971 Mylan Pharmaceuticals Inc. RASAGILINE MESYLATE 1 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 0378-1300_c5fac285-f8a7-4b1f-a51c-3662e66805a0 0378-1300 HUMAN PRESCRIPTION DRUG Lithium Carbonate lithium carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120702 ANDA ANDA202288 Mylan Pharmaceuticals Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 0378-1352_74dfd590-5c5d-4aad-bbb0-f109616741f3 0378-1352 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19960916 NDA NDA019129 Mylan Pharmaceuticals Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-1355_74dfd590-5c5d-4aad-bbb0-f109616741f3 0378-1355 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19960916 NDA NDA019129 Mylan Pharmaceuticals Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-1400_a419d720-1686-40ba-bb56-a823aa9caa3a 0378-1400 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride acebutolol hydrochloride CAPSULE ORAL 19950424 ANDA ANDA074288 Mylan Pharmaceuticals Inc. ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-1403_92884feb-23d0-4e1e-b1a4-392d2538c869 0378-1403 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET ORAL 20121231 ANDA ANDA201993 Mylan Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-1404_92884feb-23d0-4e1e-b1a4-392d2538c869 0378-1404 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET ORAL 20121231 ANDA ANDA201993 Mylan Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-1411_5906117a-d3cb-419b-b4b5-18d1f8de0db6 0378-1411 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960325 ANDA ANDA074587 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-1413_ec08bf7f-f878-4dc3-b704-cc6ec236cd59 0378-1413 HUMAN PRESCRIPTION DRUG Olmesartan Medoxmil and Hydrochlorothiazide olmesartan medoxmil and hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 ANDA ANDA078827 Mylan Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-1422_ec08bf7f-f878-4dc3-b704-cc6ec236cd59 0378-1422 HUMAN PRESCRIPTION DRUG Olmesartan Medoxmil and Hydrochlorothiazide olmesartan medoxmil and hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 ANDA ANDA078827 Mylan Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-1425_ec08bf7f-f878-4dc3-b704-cc6ec236cd59 0378-1425 HUMAN PRESCRIPTION DRUG Olmesartan Medoxmil and Hydrochlorothiazide olmesartan medoxmil and hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 ANDA ANDA078827 Mylan Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-1430_4fa78e79-6bda-4fe6-ad6f-319afb539744 0378-1430 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride nicardipine hydrochloride CAPSULE ORAL 19960719 ANDA ANDA074642 Mylan Pharmaceuticals Inc. NICARDIPINE HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0378-1450_51e9de3f-07c7-4dcb-8d46-ef8ad8d08af1 0378-1450 HUMAN PRESCRIPTION DRUG Lithium Carbonate lithium carbonate TABLET, EXTENDED RELEASE ORAL 20120809 ANDA ANDA202219 Mylan Pharmaceuticals Inc. LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] N 20181231 0378-1452_8cae2472-c4df-478d-9dbf-30fe8b10b37f 0378-1452 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 19990617 ANDA ANDA040326 Mylan Pharmaceuticals Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-1454_8cae2472-c4df-478d-9dbf-30fe8b10b37f 0378-1454 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 19990617 ANDA ANDA040326 Mylan Pharmaceuticals Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-1458_8cae2472-c4df-478d-9dbf-30fe8b10b37f 0378-1458 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 19990617 ANDA ANDA040326 Mylan Pharmaceuticals Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-1550_b9408e39-6789-4754-b774-9b84f8fd1ee7 0378-1550 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride and Metformin Hydrochloride pioglitazone hydrochloride and metformin hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA090406 Mylan Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 500 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0378-1560_2f6ab992-d9f4-4486-b6b0-72772d88339c 0378-1560 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 19990105 ANDA ANDA040298 Mylan Pharmaceuticals Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0378-1570_2ef2542c-d0fa-429d-9c96-cc3273586888 0378-1570 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous terazosin hydrochloride anhydrous CAPSULE ORAL 20000222 ANDA ANDA075140 Mylan Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-1575_b9408e39-6789-4754-b774-9b84f8fd1ee7 0378-1575 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride and Metformin Hydrochloride pioglitazone hydrochloride and metformin hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA090406 Mylan Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 850 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0378-1610_cbea3213-fd90-46f3-b145-21700c6ab692 0378-1610 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride CAPSULE ORAL 19991103 ANDA ANDA040319 Mylan Pharmaceuticals Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0378-1620_cbea3213-fd90-46f3-b145-21700c6ab692 0378-1620 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 19991103 ANDA ANDA040317 Mylan Pharmaceuticals Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0378-1626_1fcfe5e8-76b1-48a0-9ed2-e935d4f19bb3 0378-1626 HUMAN PRESCRIPTION DRUG Voriconazole voriconazole TABLET, FILM COATED ORAL 20110215 ANDA ANDA090547 Mylan Pharmaceuticals Inc. VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0378-1640_1fcfe5e8-76b1-48a0-9ed2-e935d4f19bb3 0378-1640 HUMAN PRESCRIPTION DRUG Voriconazole voriconazole TABLET, FILM COATED ORAL 20110215 ANDA ANDA090547 Mylan Pharmaceuticals Inc. VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0378-1650_815a9bdb-9a40-42bb-bc39-b44f20880747 0378-1650 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 19970909 ANDA ANDA074967 Mylan Pharmaceuticals Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0378-1657_c6f166e2-b325-4760-959d-227e79de78b6 0378-1657 HUMAN PRESCRIPTION DRUG Sildenafil sildinafil TABLET, FILM COATED ORAL 20121109 ANDA ANDA201150 Mylan Pharmaceuticals Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0378-1700_815a9bdb-9a40-42bb-bc39-b44f20880747 0378-1700 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 20040921 ANDA ANDA077025 Mylan Pharmaceuticals Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0378-1721_88f4149a-0aa4-4127-a1de-4762dc9c55fc 0378-1721 HUMAN PRESCRIPTION DRUG AMLODIPINE AND VALSARTAN AMLODIPINE AND VALSARTAN TABLET, FILM COATED ORAL 20150330 ANDA ANDA090483 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-1722_88f4149a-0aa4-4127-a1de-4762dc9c55fc 0378-1722 HUMAN PRESCRIPTION DRUG AMLODIPINE AND VALSARTAN AMLODIPINE AND VALSARTAN TABLET, FILM COATED ORAL 20150330 ANDA ANDA090483 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-1723_88f4149a-0aa4-4127-a1de-4762dc9c55fc 0378-1723 HUMAN PRESCRIPTION DRUG AMLODIPINE AND VALSARTAN AMLODIPINE AND VALSARTAN TABLET, FILM COATED ORAL 20150330 ANDA ANDA090483 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-1724_88f4149a-0aa4-4127-a1de-4762dc9c55fc 0378-1724 HUMAN PRESCRIPTION DRUG AMLODIPINE AND VALSARTAN AMLODIPINE AND VALSARTAN TABLET, FILM COATED ORAL 20150330 ANDA ANDA090483 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-1730_dd2ea7ee-d663-4bc8-ad5f-99c676da8ad1 0378-1730 HUMAN PRESCRIPTION DRUG Ursodiol ursodiol CAPSULE ORAL 20160105 ANDA ANDA090530 Mylan Pharmaceuticals Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 0378-1743_0e09ac50-3bcd-47e4-8fcc-3e60941a717d 0378-1743 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070322 ANDA ANDA078183 Mylan Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE; CIPROFLOXACIN 287.5; 212.6 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 0378-1745_0e09ac50-3bcd-47e4-8fcc-3e60941a717d 0378-1745 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070322 ANDA ANDA078183 Mylan Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE; CIPROFLOXACIN 574.9; 425.2 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 0378-1800_3995dbbc-92f8-4c99-b51f-6fb0b64aef5d 0378-1800 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0378-1803_3995dbbc-92f8-4c99-b51f-6fb0b64aef5d 0378-1803 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0378-1805_3995dbbc-92f8-4c99-b51f-6fb0b64aef5d 0378-1805 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0378-1807_3995dbbc-92f8-4c99-b51f-6fb0b64aef5d 0378-1807 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0378-1809_3995dbbc-92f8-4c99-b51f-6fb0b64aef5d 0378-1809 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0378-1811_3995dbbc-92f8-4c99-b51f-6fb0b64aef5d 0378-1811 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0378-1813_3995dbbc-92f8-4c99-b51f-6fb0b64aef5d 0378-1813 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0378-1815_3995dbbc-92f8-4c99-b51f-6fb0b64aef5d 0378-1815 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0378-1817_3995dbbc-92f8-4c99-b51f-6fb0b64aef5d 0378-1817 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0378-1819_3995dbbc-92f8-4c99-b51f-6fb0b64aef5d 0378-1819 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0378-1821_3995dbbc-92f8-4c99-b51f-6fb0b64aef5d 0378-1821 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 300 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0378-1823_3995dbbc-92f8-4c99-b51f-6fb0b64aef5d 0378-1823 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20061215 ANDA ANDA076187 Mylan Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0378-1901_c373301c-6d82-4f37-9ec1-7a9662c3c388 0378-1901 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20030911 ANDA ANDA076577 Mylan Pharmaceuticals Inc. MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0378-1902_c373301c-6d82-4f37-9ec1-7a9662c3c388 0378-1902 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20030911 ANDA ANDA076577 Mylan Pharmaceuticals Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0378-1903_c373301c-6d82-4f37-9ec1-7a9662c3c388 0378-1903 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20030911 ANDA ANDA076577 Mylan Pharmaceuticals Inc. MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0378-1910_6d5e11ff-2d93-420d-96c6-60bef55333ac 0378-1910 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 19981020 ANDA ANDA075150 Mylan Pharmaceuticals Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-1912_6d5e11ff-2d93-420d-96c6-60bef55333ac 0378-1912 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 19981020 ANDA ANDA075150 Mylan Pharmaceuticals Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-1914_6d5e11ff-2d93-420d-96c6-60bef55333ac 0378-1914 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 19981020 ANDA ANDA075150 Mylan Pharmaceuticals Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-2002_942272de-0dad-4718-bdce-b745dff16e9e 0378-2002 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19870623 ANDA ANDA071093 Mylan Pharmaceuticals Inc. THIOTHIXENE 2 mg/1 Typical Antipsychotic [EPC] N 20181231 0378-2003_57436765-0ac7-4028-91bc-2bde0f2a787a 0378-2003 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080514 ANDA ANDA077873 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-2004_57436765-0ac7-4028-91bc-2bde0f2a787a 0378-2004 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080514 ANDA ANDA077873 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-2005_57436765-0ac7-4028-91bc-2bde0f2a787a 0378-2005 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110505 ANDA ANDA091427 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-2008_3778e5e8-e10f-4273-acc5-eb6733c987dc 0378-2008 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100928 ANDA ANDA090942 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0378-2009_3778e5e8-e10f-4273-acc5-eb6733c987dc 0378-2009 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100928 ANDA ANDA090942 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0378-2012_8d0a4642-f635-4781-b6e9-ae08bed99b96 0378-2012 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20140904 ANDA ANDA076113 Mylan Pharmaceuticals Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-2025_8d0a4642-f635-4781-b6e9-ae08bed99b96 0378-2025 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20140904 ANDA ANDA076113 Mylan Pharmaceuticals Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-2042_4af5d2ca-f09e-4311-9db9-a9457d8bf01b 0378-2042 HUMAN PRESCRIPTION DRUG Bromocriptine Mesylate bromocriptine mesylate TABLET ORAL 20130605 ANDA ANDA076962 Mylan Pharmaceuticals Inc. BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 0378-2045_34cc978e-e6eb-4fd4-a186-e335612ca902 0378-2045 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100917 ANDA ANDA090596 Mylan Pharmaceuticals Inc. TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 0378-2046_34cc978e-e6eb-4fd4-a186-e335612ca902 0378-2046 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100917 ANDA ANDA090596 Mylan Pharmaceuticals Inc. TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 0378-2047_34cc978e-e6eb-4fd4-a186-e335612ca902 0378-2047 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100917 ANDA ANDA090596 Mylan Pharmaceuticals Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 0378-2063_b5a8175b-6ceb-4b38-ab56-39b8793f48a0 0378-2063 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone atenolol and chlorthalidone TABLET ORAL 19931031 ANDA ANDA074203 Mylan Pharmaceuticals Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0378-2064_b5a8175b-6ceb-4b38-ab56-39b8793f48a0 0378-2064 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone atenolol and chlorthalidone TABLET ORAL 19931031 ANDA ANDA074203 Mylan Pharmaceuticals Inc. ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0378-2072_7503cecb-d4a2-43be-b4c7-cf932c99de12 0378-2072 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Mylan Pharmaceuticals Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0378-2073_7503cecb-d4a2-43be-b4c7-cf932c99de12 0378-2073 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Mylan Pharmaceuticals Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0378-2074_7503cecb-d4a2-43be-b4c7-cf932c99de12 0378-2074 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Mylan Pharmaceuticals Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0378-2075_7503cecb-d4a2-43be-b4c7-cf932c99de12 0378-2075 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Mylan Pharmaceuticals Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0378-2076_7503cecb-d4a2-43be-b4c7-cf932c99de12 0378-2076 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Mylan Pharmaceuticals Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0378-2077_7503cecb-d4a2-43be-b4c7-cf932c99de12 0378-2077 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA076071 Mylan Pharmaceuticals Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0378-2096_2d6fd17f-3c2c-4337-9a66-b789f5711d3f 0378-2096 HUMAN PRESCRIPTION DRUG Nisoldipine nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110128 ANDA ANDA091001 Mylan Pharmaceuticals Inc. NISOLDIPINE 8.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 0378-2097_2d6fd17f-3c2c-4337-9a66-b789f5711d3f 0378-2097 HUMAN PRESCRIPTION DRUG Nisoldipine nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110128 ANDA ANDA091001 Mylan Pharmaceuticals Inc. NISOLDIPINE 17 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 0378-2098_2d6fd17f-3c2c-4337-9a66-b789f5711d3f 0378-2098 HUMAN PRESCRIPTION DRUG Nisoldipine nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110128 ANDA ANDA091001 Mylan Pharmaceuticals Inc. NISOLDIPINE 25.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 0378-2099_2d6fd17f-3c2c-4337-9a66-b789f5711d3f 0378-2099 HUMAN PRESCRIPTION DRUG Nisoldipine nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110128 ANDA ANDA091001 Mylan Pharmaceuticals Inc. NISOLDIPINE 34 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 0378-2100_f196ca68-7850-45b5-805c-064b6f8d8310 0378-2100 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 19910918 ANDA ANDA072741 Mylan Pharmaceuticals Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 0378-2120_5906117a-d3cb-419b-b4b5-18d1f8de0db6 0378-2120 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970225 ANDA ANDA074587 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-2146_58035cf5-f25a-4e9b-92ba-e4f8622822aa 0378-2146 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19810203 ANDA ANDA040424 Mylan Pharmaceuticals Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0378-2150_939c7a2c-483f-4b5b-87a1-52e26fd4e469 0378-2150 HUMAN PRESCRIPTION DRUG Meclofenamate Sodium meclofenamate sodium CAPSULE ORAL 19860903 ANDA ANDA071081 Mylan Pharmaceuticals Inc. MECLOFENAMATE SODIUM 50 mg/1 N 20181231 0378-2180_5906117a-d3cb-419b-b4b5-18d1f8de0db6 0378-2180 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970922 ANDA ANDA074587 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-2201_3d188248-270e-4922-bf98-7004658602fe 0378-2201 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079161 Mylan Pharmaceuticals Inc. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-2203_3d188248-270e-4922-bf98-7004658602fe 0378-2203 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079161 Mylan Pharmaceuticals Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-2204_3d188248-270e-4922-bf98-7004658602fe 0378-2204 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079161 Mylan Pharmaceuticals Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-2222_a88f1e80-606e-4c39-a053-718d7537ef01 0378-2222 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080725 ANDA ANDA079051 Mylan Pharmaceuticals Inc. NISOLDIPINE 20 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 0378-2223_a88f1e80-606e-4c39-a053-718d7537ef01 0378-2223 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080725 ANDA ANDA079051 Mylan Pharmaceuticals Inc. NISOLDIPINE 30 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 0378-2224_a88f1e80-606e-4c39-a053-718d7537ef01 0378-2224 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080725 ANDA ANDA079051 Mylan Pharmaceuticals Inc. NISOLDIPINE 40 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 0378-2232_3d188248-270e-4922-bf98-7004658602fe 0378-2232 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079161 Mylan Pharmaceuticals Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-2233_8172caa9-22bf-4be5-8cce-2e874e7c28e2 0378-2233 HUMAN PRESCRIPTION DRUG Efavirenz efavirenz TABLET, FILM COATED ORAL 20180130 ANDA ANDA091471 Mylan Pharmaceuticals Inc. EFAVIRENZ 600 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20191231 0378-2245_32fad80d-3320-49fc-b6bd-9f60ad92b219 0378-2245 HUMAN PRESCRIPTION DRUG Imatinib Mesylate imatinib TABLET, FILM COATED ORAL 20170928 ANDA ANDA204644 Mylan Pharmaceuticals Inc. IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 0378-2246_32fad80d-3320-49fc-b6bd-9f60ad92b219 0378-2246 HUMAN PRESCRIPTION DRUG Imatinib Mesylate imatinib TABLET, FILM COATED ORAL 20170928 ANDA ANDA204644 Mylan Pharmaceuticals Inc. IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 0378-2250_b8acb6e8-c850-4a10-946f-05901c4be829 0378-2250 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil CAPSULE ORAL 20090504 ANDA ANDA065520 Mylan Pharmaceuticals Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 0378-2260_2ef2542c-d0fa-429d-9c96-cc3273586888 0378-2260 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous terazosin hydrochloride anhydrous CAPSULE ORAL 20000222 ANDA ANDA075140 Mylan Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-2264_2ef2542c-d0fa-429d-9c96-cc3273586888 0378-2264 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous terazosin hydrochloride anhydrous CAPSULE ORAL 20000222 ANDA ANDA075140 Mylan Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-2268_2ef2542c-d0fa-429d-9c96-cc3273586888 0378-2268 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous terazosin hydrochloride anhydrous CAPSULE ORAL 20000222 ANDA ANDA075140 Mylan Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-2302_fc3761eb-16d8-4c67-bc71-5436c393efac 0378-2302 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19890228 ANDA ANDA072575 Mylan Pharmaceuticals Inc. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-2321_a1e15bdb-ca3c-4de2-9086-43f8c09a0e25 0378-2321 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061227 ANDA ANDA077657 Mylan Pharmaceuticals Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-2350_0c70be17-0c7a-4101-afd4-817ab3c205b9 0378-2350 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE PELLETS ORAL 20150803 ANDA ANDA078936 Mylan Pharmaceuticals Inc. ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0378-2351_0c70be17-0c7a-4101-afd4-817ab3c205b9 0378-2351 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE PELLETS ORAL 20150803 ANDA ANDA078936 Mylan Pharmaceuticals Inc. ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0378-2401_0c5ea8c4-76d9-496a-b769-b238b9b6b0c6 0378-2401 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA040209 Mylan Pharmaceuticals Inc. TRIFLUOPERAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-2402_0c5ea8c4-76d9-496a-b769-b238b9b6b0c6 0378-2402 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA040209 Mylan Pharmaceuticals Inc. TRIFLUOPERAZINE HYDROCHLORIDE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-2405_0c5ea8c4-76d9-496a-b769-b238b9b6b0c6 0378-2405 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA040209 Mylan Pharmaceuticals Inc. TRIFLUOPERAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-2410_0c5ea8c4-76d9-496a-b769-b238b9b6b0c6 0378-2410 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA040209 Mylan Pharmaceuticals Inc. TRIFLUOPERAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-2457_a1e15bdb-ca3c-4de2-9086-43f8c09a0e25 0378-2457 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061227 ANDA ANDA077657 Mylan Pharmaceuticals Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-2474_5dad4936-6e19-419a-b923-7ee139a8e031 0378-2474 HUMAN PRESCRIPTION DRUG Diclofenac Potassium diclofenac potassium TABLET, FILM COATED ORAL 19990917 ANDA ANDA075463 Mylan Pharmaceuticals Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-2500_588de909-c680-4cc5-93ed-ceadaa30f0bd 0378-2500 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA090408 Mylan Pharmaceuticals Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-2511_069199ca-5268-4f7c-9334-859b392feb3a 0378-2511 HUMAN PRESCRIPTION DRUG Capecitabine capecitabine TABLET, FILM COATED ORAL 20140808 ANDA ANDA090943 Mylan Pharmaceuticals Inc. CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0378-2512_069199ca-5268-4f7c-9334-859b392feb3a 0378-2512 HUMAN PRESCRIPTION DRUG Capecitabine capecitabine TABLET, FILM COATED ORAL 20140808 ANDA ANDA090943 Mylan Pharmaceuticals Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0378-2537_9641f4e0-df7d-4f95-9b2c-1fad2c9ee089 0378-2537 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide triamterene and hydrochlorothiazide CAPSULE ORAL 19960607 ANDA ANDA074701 Mylan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 0378-2586_4f04ec91-1fe9-4048-8e50-e58a25c9c70a 0378-2586 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100723 ANDA ANDA091176 Mylan Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0378-2587_4f04ec91-1fe9-4048-8e50-e58a25c9c70a 0378-2587 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100723 ANDA ANDA091176 Mylan Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0378-2588_4f04ec91-1fe9-4048-8e50-e58a25c9c70a 0378-2588 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100723 ANDA ANDA091176 Mylan Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0378-2589_b1502483-d3af-4083-b0a5-1cd9a9b3237e 0378-2589 HUMAN PRESCRIPTION DRUG Fenofibric Acid fenofibric acid CAPSULE, DELAYED RELEASE PELLETS ORAL 20130715 ANDA ANDA200913 Mylan Pharmaceuticals Inc. FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-2590_b1502483-d3af-4083-b0a5-1cd9a9b3237e 0378-2590 HUMAN PRESCRIPTION DRUG Fenofibric Acid fenofibric acid CAPSULE, DELAYED RELEASE PELLETS ORAL 20130715 ANDA ANDA200913 Mylan Pharmaceuticals Inc. FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-2610_5f45450d-bc51-4769-a679-982feb8e2f35 0378-2610 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0378-2625_5f45450d-bc51-4769-a679-982feb8e2f35 0378-2625 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0378-2650_5f45450d-bc51-4769-a679-982feb8e2f35 0378-2650 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0378-2658_03432fb4-47fa-4b87-9887-02a46d58fd43 0378-2658 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141118 ANDA ANDA200824 Mylan Pharmaceuticals Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-2659_03432fb4-47fa-4b87-9887-02a46d58fd43 0378-2659 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141118 ANDA ANDA200824 Mylan Pharmaceuticals Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-2660_03432fb4-47fa-4b87-9887-02a46d58fd43 0378-2660 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141118 ANDA ANDA200824 Mylan Pharmaceuticals Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-2661_03432fb4-47fa-4b87-9887-02a46d58fd43 0378-2661 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141118 ANDA ANDA200824 Mylan Pharmaceuticals Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-2662_03432fb4-47fa-4b87-9887-02a46d58fd43 0378-2662 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141118 ANDA ANDA200824 Mylan Pharmaceuticals Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-2670_4fd43b6f-ad08-4ca3-94ef-966a3c7d5fa6 0378-2670 HUMAN PRESCRIPTION DRUG Phenytek extended phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20011210 ANDA ANDA040298 Mylan Pharmaceuticals Inc. PHENYTOIN SODIUM 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0378-2675_5f45450d-bc51-4769-a679-982feb8e2f35 0378-2675 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0378-2685_5f45450d-bc51-4769-a679-982feb8e2f35 0378-2685 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0378-2695_5f45450d-bc51-4769-a679-982feb8e2f35 0378-2695 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Mylan Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0378-2721_260cccc7-5e3f-4baf-875f-85fdf8389719 0378-2721 HUMAN PRESCRIPTION DRUG Galantamine galantamine TABLET, FILM COATED ORAL 20080829 ANDA ANDA077590 Mylan Pharmaceuticals Inc. GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0378-2722_260cccc7-5e3f-4baf-875f-85fdf8389719 0378-2722 HUMAN PRESCRIPTION DRUG Galantamine galantamine TABLET, FILM COATED ORAL 20080829 ANDA ANDA077590 Mylan Pharmaceuticals Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0378-2723_260cccc7-5e3f-4baf-875f-85fdf8389719 0378-2723 HUMAN PRESCRIPTION DRUG Galantamine galantamine TABLET, FILM COATED ORAL 20080829 ANDA ANDA077590 Mylan Pharmaceuticals Inc. GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0378-2777_a1e15bdb-ca3c-4de2-9086-43f8c09a0e25 0378-2777 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061227 ANDA ANDA077657 Mylan Pharmaceuticals Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-2920_0e045d1e-b705-4b7d-b752-1d0e8283be4f 0378-2920 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20140707 ANDA ANDA202397 Mylan Pharmaceuticals Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-2921_0e045d1e-b705-4b7d-b752-1d0e8283be4f 0378-2921 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20140707 ANDA ANDA202397 Mylan Pharmaceuticals Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-2922_0e045d1e-b705-4b7d-b752-1d0e8283be4f 0378-2922 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20140707 ANDA ANDA202397 Mylan Pharmaceuticals Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-3000_939c7a2c-483f-4b5b-87a1-52e26fd4e469 0378-3000 HUMAN PRESCRIPTION DRUG Meclofenamate Sodium meclofenamate sodium CAPSULE ORAL 19860903 ANDA ANDA071081 Mylan Pharmaceuticals Inc. MECLOFENAMATE SODIUM 100 mg/1 N 20181231 0378-3001_a3322b47-0cfc-49b4-8a5a-9b5e3c2ac9fc 0378-3001 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide candesartan cilexetil and hydrochlorothiazide TABLET ORAL 20121204 ANDA ANDA090704 Mylan Pharmaceuticals Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-3002_a3322b47-0cfc-49b4-8a5a-9b5e3c2ac9fc 0378-3002 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide candesartan cilexetil and hydrochlorothiazide TABLET ORAL 20121204 ANDA ANDA090704 Mylan Pharmaceuticals Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-3003_a3322b47-0cfc-49b4-8a5a-9b5e3c2ac9fc 0378-3003 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide candesartan cilexetil and hydrochlorothiazide TABLET ORAL 20121204 ANDA ANDA090704 Mylan Pharmaceuticals Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-3005_942272de-0dad-4718-bdce-b745dff16e9e 0378-3005 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19870623 ANDA ANDA071093 Mylan Pharmaceuticals Inc. THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] N 20181231 0378-3007_10ce69aa-eb93-4745-96b8-96a72f324dcc 0378-3007 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 19960213 ANDA ANDA074434 Mylan Pharmaceuticals Inc. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0378-3012_10ce69aa-eb93-4745-96b8-96a72f324dcc 0378-3012 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 19960213 ANDA ANDA074434 Mylan Pharmaceuticals Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0378-3017_10ce69aa-eb93-4745-96b8-96a72f324dcc 0378-3017 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 19960213 ANDA ANDA074434 Mylan Pharmaceuticals Inc. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0378-3020_fc450645-ec1e-4334-a423-f8f77cf720f3 0378-3020 HUMAN PRESCRIPTION DRUG Famotidine famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075704 Mylan Pharmaceuticals Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0378-3022_10ce69aa-eb93-4745-96b8-96a72f324dcc 0378-3022 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 19960213 ANDA ANDA074434 Mylan Pharmaceuticals Inc. CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0378-3025_d08e85dc-1e5e-40c2-92e8-b97cd3b7fef8 0378-3025 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride clomipramine hydrochloride CAPSULE ORAL 19980511 ANDA ANDA074947 Mylan Pharmaceuticals Inc. CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0378-3030_e6945d56-c48e-4274-b0bc-67ce4ae2b0c6 0378-3030 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20120430 ANDA ANDA091052 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 150 mg/1 N 20191231 0378-3040_fc450645-ec1e-4334-a423-f8f77cf720f3 0378-3040 HUMAN PRESCRIPTION DRUG Famotidine famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075704 Mylan Pharmaceuticals Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0378-3050_d08e85dc-1e5e-40c2-92e8-b97cd3b7fef8 0378-3050 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride clomipramine hydrochloride CAPSULE ORAL 19980511 ANDA ANDA074947 Mylan Pharmaceuticals Inc. CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0378-3065_de84c172-5279-477a-8d5b-4a9ad5885389 0378-3065 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20130514 ANDA ANDA202856 Mylan Pharmaceuticals Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-3066_de84c172-5279-477a-8d5b-4a9ad5885389 0378-3066 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20130514 ANDA ANDA202856 Mylan Pharmaceuticals Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-3075_d08e85dc-1e5e-40c2-92e8-b97cd3b7fef8 0378-3075 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride clomipramine hydrochloride CAPSULE ORAL 19980511 ANDA ANDA074947 Mylan Pharmaceuticals Inc. CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0378-3110_1bdfcd1e-6e57-4d5a-9940-2fd81d487cfb 0378-3110 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20100518 ANDA ANDA070920 Mylan Pharmaceuticals Inc. TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-3120_1bdfcd1e-6e57-4d5a-9940-2fd81d487cfb 0378-3120 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20090615 ANDA ANDA070920 Mylan Pharmaceuticals Inc. TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-3121_5d82267a-40dc-459f-877d-1d840097247e 0378-3121 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20130827 ANDA ANDA090252 Mylan Pharmaceuticals Inc. REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0378-3122_5d82267a-40dc-459f-877d-1d840097247e 0378-3122 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20140122 ANDA ANDA090252 Mylan Pharmaceuticals Inc. REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0378-3123_5d82267a-40dc-459f-877d-1d840097247e 0378-3123 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20140122 ANDA ANDA090252 Mylan Pharmaceuticals Inc. REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0378-3125_573022de-0245-4b68-8341-c3ebf11031cb 0378-3125 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Mylan Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 0378-3131_fb213b03-0e74-4397-989c-bfa56da7f90e 0378-3131 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride glipizide and metformin hydrochloride TABLET, FILM COATED ORAL 20070412 ANDA ANDA078083 Mylan Pharmaceuticals Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0378-3132_fb213b03-0e74-4397-989c-bfa56da7f90e 0378-3132 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride glipizide and metformin hydrochloride TABLET, FILM COATED ORAL 20070412 ANDA ANDA078083 Mylan Pharmaceuticals Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0378-3133_fb213b03-0e74-4397-989c-bfa56da7f90e 0378-3133 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride glipizide and metformin hydrochloride TABLET, FILM COATED ORAL 20070412 ANDA ANDA078083 Mylan Pharmaceuticals Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0378-3140_626483a8-a543-4183-99bd-7293767881ad 0378-3140 HUMAN PRESCRIPTION DRUG Frovatriptan frovatriptan TABLET, FILM COATED ORAL 20160429 ANDA ANDA202931 Mylan Pharmaceuticals Inc. FROVATRIPTAN SUCCINATE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-3205_fc3761eb-16d8-4c67-bc71-5436c393efac 0378-3205 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19890228 ANDA ANDA072575 Mylan Pharmaceuticals Inc. PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-3266_a91c86a3-28dc-4ffd-894d-3b7740ae4e42 0378-3266 HUMAN PRESCRIPTION DRUG Etoposide etoposide CAPSULE ORAL 20011022 ANDA ANDA075635 Mylan Pharmaceuticals Inc. ETOPOSIDE 50 mg/1 Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0378-3286_1c3be377-d59d-4424-b7bd-649e3133b8cd 0378-3286 HUMAN PRESCRIPTION DRUG Etidronate Disodium etidronate disodium TABLET ORAL 20080102 20191130 ANDA ANDA075800 Mylan Pharmaceuticals Inc. ETIDRONATE DISODIUM 200 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0378-3288_1c3be377-d59d-4424-b7bd-649e3133b8cd 0378-3288 HUMAN PRESCRIPTION DRUG Etidronate Disodium etidronate disodium TABLET ORAL 20080102 ANDA ANDA075800 Mylan Pharmaceuticals Inc. ETIDRONATE DISODIUM 400 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0378-3340_d7a91bd6-f521-4093-8211-05c7a446c3c6 0378-3340 HUMAN PRESCRIPTION DRUG XULANE norelgestromin and ethinyl estradiol PATCH TRANSDERMAL 20140416 ANDA ANDA200910 Mylan Pharmaceuticals Inc. NORELGESTROMIN; ETHINYL ESTRADIOL 150; 35 ug/d; ug/d Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-3349_afc96721-01f4-4a2b-99e0-b5f0c62e1127 0378-3349 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20050407 ANDA ANDA075182 Mylan Pharmaceuticals Inc. ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-3350_afc96721-01f4-4a2b-99e0-b5f0c62e1127 0378-3350 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20000301 ANDA ANDA075182 Mylan Pharmaceuticals Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-3351_afc96721-01f4-4a2b-99e0-b5f0c62e1127 0378-3351 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20050407 ANDA ANDA075182 Mylan Pharmaceuticals Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-3352_afc96721-01f4-4a2b-99e0-b5f0c62e1127 0378-3352 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20000301 ANDA ANDA075182 Mylan Pharmaceuticals Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-3360_afc96721-01f4-4a2b-99e0-b5f0c62e1127 0378-3360 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20060809 ANDA ANDA075182 Mylan Pharmaceuticals Inc. ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-3361_afc96721-01f4-4a2b-99e0-b5f0c62e1127 0378-3361 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20060809 ANDA ANDA075182 Mylan Pharmaceuticals Inc. ESTRADIOL .06 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-3402_de3acfaf-9bf1-4812-a56c-1cc92e316dc2 0378-3402 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20131031 ANDA ANDA201486 Mylan Pharmaceuticals Inc. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0378-3404_de3acfaf-9bf1-4812-a56c-1cc92e316dc2 0378-3404 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20131031 ANDA ANDA201486 Mylan Pharmaceuticals Inc. TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0378-3411_d2897220-f6fd-4219-be81-702aa69f1544 0378-3411 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100409 ANDA ANDA090325 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0378-3412_d2897220-f6fd-4219-be81-702aa69f1544 0378-3412 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100409 ANDA ANDA090325 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0378-3413_d2897220-f6fd-4219-be81-702aa69f1544 0378-3413 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100409 ANDA ANDA090325 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0378-3422_578d94ef-3668-4c7a-8c56-e17195b3eeca 0378-3422 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/Macrocrystals Nitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline CAPSULE ORAL 20040323 ANDA ANDA076648 Mylan Pharmaceuticals Inc. NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0378-3431_de0799f7-7644-4057-a7da-75436f978c61 0378-3431 HUMAN PRESCRIPTION DRUG Armodafinil armodafinil TABLET ORAL 20160601 ANDA ANDA200043 Mylan Pharmaceuticals Inc. ARMODAFINIL 50 mg/1 CIV N 20181231 0378-3432_de0799f7-7644-4057-a7da-75436f978c61 0378-3432 HUMAN PRESCRIPTION DRUG Armodafinil armodafinil TABLET ORAL 20160601 ANDA ANDA200043 Mylan Pharmaceuticals Inc. ARMODAFINIL 150 mg/1 CIV N 20181231 0378-3433_de0799f7-7644-4057-a7da-75436f978c61 0378-3433 HUMAN PRESCRIPTION DRUG Armodafinil armodafinil TABLET ORAL 20160601 ANDA ANDA200043 Mylan Pharmaceuticals Inc. ARMODAFINIL 250 mg/1 CIV N 20181231 0378-3502_72e8485c-3d64-463a-b025-fedc067f65e0 0378-3502 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Mylan Pharmaceuticals Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-3505_72e8485c-3d64-463a-b025-fedc067f65e0 0378-3505 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Mylan Pharmaceuticals Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-3511_72e8485c-3d64-463a-b025-fedc067f65e0 0378-3511 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Mylan Pharmaceuticals Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-3512_72e8485c-3d64-463a-b025-fedc067f65e0 0378-3512 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Mylan Pharmaceuticals Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-3513_72e8485c-3d64-463a-b025-fedc067f65e0 0378-3513 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Mylan Pharmaceuticals Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-3514_72e8485c-3d64-463a-b025-fedc067f65e0 0378-3514 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Mylan Pharmaceuticals Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-3515_be24919d-dd45-4060-a3d0-01b5985fdacb 0378-3515 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20121228 ANDA ANDA076122 Mylan Pharmaceuticals Inc. MIRTAZAPINE 15 mg/1 N 20181231 0378-3520_2c4936b2-9279-4c57-ba9d-2e942d6e81ae 0378-3520 HUMAN PRESCRIPTION DRUG Fosamprenavir Calcium fosamprenavir calcium TABLET, FILM COATED ORAL 20170918 ANDA ANDA204060 Mylan Pharmaceuticals Inc. FOSAMPRENAVIR CALCIUM 700 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],P-Glycoprotein Inducers [MoA] N 20181231 0378-3530_be24919d-dd45-4060-a3d0-01b5985fdacb 0378-3530 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20121228 ANDA ANDA076122 Mylan Pharmaceuticals Inc. MIRTAZAPINE 30 mg/1 N 20181231 0378-3545_be24919d-dd45-4060-a3d0-01b5985fdacb 0378-3545 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20121228 ANDA ANDA076122 Mylan Pharmaceuticals Inc. MIRTAZAPINE 45 mg/1 N 20181231 0378-3547_a9a03c08-a7c7-4f45-b2f8-f059d55e8b01 0378-3547 HUMAN PRESCRIPTION DRUG Mercaptopurine mercaptopurine TABLET ORAL 20050714 ANDA ANDA040594 Mylan Pharmaceuticals Inc. MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0378-3566_4b61694c-8214-4402-967e-fb26b952adcb 0378-3566 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080804 20190331 ANDA ANDA076584 Mylan Pharmaceuticals Inc. ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0378-3567_4b61694c-8214-4402-967e-fb26b952adcb 0378-3567 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080804 20181031 ANDA ANDA076584 Mylan Pharmaceuticals Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0378-3568_4b61694c-8214-4402-967e-fb26b952adcb 0378-3568 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20110325 20180331 ANDA ANDA076584 Mylan Pharmaceuticals Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0378-3569_4b61694c-8214-4402-967e-fb26b952adcb 0378-3569 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20110325 20180331 ANDA ANDA076584 Mylan Pharmaceuticals Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0378-3611_d8488d16-e67b-4c02-9ab0-7e99e81e6aa0 0378-3611 HUMAN PRESCRIPTION DRUG Liothyronine sodium Liothyronine sodium TABLET ORAL 20161003 ANDA ANDA090326 Mylan Pharmaceuticals Inc. LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20191231 0378-3612_d8488d16-e67b-4c02-9ab0-7e99e81e6aa0 0378-3612 HUMAN PRESCRIPTION DRUG Liothyronine sodium Liothyronine sodium TABLET ORAL 20161003 ANDA ANDA090326 Mylan Pharmaceuticals Inc. LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20191231 0378-3613_d8488d16-e67b-4c02-9ab0-7e99e81e6aa0 0378-3613 HUMAN PRESCRIPTION DRUG Liothyronine sodium Liothyronine sodium TABLET ORAL 20161003 ANDA ANDA090326 Mylan Pharmaceuticals Inc. LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20191231 0378-3627_e1f02ffb-2541-4340-b64b-5b6b2fb302f5 0378-3627 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate clopidogrel TABLET, FILM COATED ORAL 20150414 ANDA ANDA077665 Mylan Pharmaceuticals Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 0378-3628_e1f02ffb-2541-4340-b64b-5b6b2fb302f5 0378-3628 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate clopidogrel TABLET, FILM COATED ORAL 20160128 ANDA ANDA077665 Mylan Pharmaceuticals Inc. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 0378-3631_fbf3fd92-0b62-44dd-b3ce-b43d9189046f 0378-3631 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Mylan Pharmaceuticals Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0378-3632_fbf3fd92-0b62-44dd-b3ce-b43d9189046f 0378-3632 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Mylan Pharmaceuticals Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0378-3633_fbf3fd92-0b62-44dd-b3ce-b43d9189046f 0378-3633 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Mylan Pharmaceuticals Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0378-3634_fbf3fd92-0b62-44dd-b3ce-b43d9189046f 0378-3634 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Mylan Pharmaceuticals Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0378-3635_0ba0160c-3b23-4aea-97dc-b4938c906b47 0378-3635 HUMAN OTC DRUG Cetirizine Hydrochloride cetirizine hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA076677 Mylan Pharmaceuticals Inc. CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 0378-3637_0ba0160c-3b23-4aea-97dc-b4938c906b47 0378-3637 HUMAN OTC DRUG Cetirizine Hydrochloride cetirizine hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA076677 Mylan Pharmaceuticals Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0378-3701_b529a376-fec9-4668-adfb-084d8d7927d9 0378-3701 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20121231 ANDA ANDA078173 Mylan Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-3702_b529a376-fec9-4668-adfb-084d8d7927d9 0378-3702 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20121231 ANDA ANDA078173 Mylan Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-3750_4fd43b6f-ad08-4ca3-94ef-966a3c7d5fa6 0378-3750 HUMAN PRESCRIPTION DRUG Phenytek phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20011210 ANDA ANDA040298 Mylan Pharmaceuticals Inc. PHENYTOIN SODIUM 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0378-3813_92ccf261-8444-4f7c-b6ec-5019b657b38d 0378-3813 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET, ORALLY DISINTEGRATING ORAL 20151102 ANDA ANDA201824 Mylan Pharmaceuticals Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-3815_92ccf261-8444-4f7c-b6ec-5019b657b38d 0378-3815 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET, ORALLY DISINTEGRATING ORAL 20151102 ANDA ANDA201824 Mylan Pharmaceuticals Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-3850_3017715a-7371-44f4-895a-504a34124566 0378-3850 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin TABLET, CHEWABLE ORAL 20121226 ANDA ANDA200691 Mylan Pharmaceuticals Inc. PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0378-3855_e4bded39-6d62-4e4f-b9c2-ca5566902d5c 0378-3855 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20120229 NDA NDA021323 Mylan Pharmaceuticals Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-3856_e4bded39-6d62-4e4f-b9c2-ca5566902d5c 0378-3856 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20120229 NDA NDA021323 Mylan Pharmaceuticals Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-3857_e4bded39-6d62-4e4f-b9c2-ca5566902d5c 0378-3857 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20120229 NDA NDA021323 Mylan Pharmaceuticals Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-3950_e383292d-e077-4332-9b4e-4d9157d11a03 0378-3950 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20130919 ANDA ANDA091226 Mylan Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-3951_e383292d-e077-4332-9b4e-4d9157d11a03 0378-3951 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20130919 ANDA ANDA091226 Mylan Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-3952_e383292d-e077-4332-9b4e-4d9157d11a03 0378-3952 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20130919 ANDA ANDA091226 Mylan Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-3953_e383292d-e077-4332-9b4e-4d9157d11a03 0378-3953 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20130919 ANDA ANDA091226 Mylan Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-3978_c0cdc0cb-7b3f-48d5-ab5a-770fa08d1c30 0378-3978 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150924 ANDA ANDA203802 Mylan Pharmaceuticals Inc. PALIPERIDONE 1.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-3979_c0cdc0cb-7b3f-48d5-ab5a-770fa08d1c30 0378-3979 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150924 ANDA ANDA203802 Mylan Pharmaceuticals Inc. PALIPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-3980_c0cdc0cb-7b3f-48d5-ab5a-770fa08d1c30 0378-3980 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150924 ANDA ANDA203802 Mylan Pharmaceuticals Inc. PALIPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-3981_c0cdc0cb-7b3f-48d5-ab5a-770fa08d1c30 0378-3981 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150924 ANDA ANDA203802 Mylan Pharmaceuticals Inc. PALIPERIDONE 9 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-4001_aa68fb72-3799-4450-986b-588dd79693d4 0378-4001 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120723 ANDA ANDA074215 Mylan Pharmaceuticals Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-4003_aa68fb72-3799-4450-986b-588dd79693d4 0378-4003 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120723 ANDA ANDA074215 Mylan Pharmaceuticals Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-4005_aa68fb72-3799-4450-986b-588dd79693d4 0378-4005 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19940128 ANDA ANDA074215 Mylan Pharmaceuticals Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-4007_aa68fb72-3799-4450-986b-588dd79693d4 0378-4007 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19940128 ANDA ANDA074215 Mylan Pharmaceuticals Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-4010_1bdfcd1e-6e57-4d5a-9940-2fd81d487cfb 0378-4010 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19860710 ANDA ANDA070920 Mylan Pharmaceuticals Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-4011_30616b3c-93fd-4c54-abfa-7c9a5cfbdd40 0378-4011 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20060301 ANDA ANDA077624 Mylan Pharmaceuticals Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-4012_30616b3c-93fd-4c54-abfa-7c9a5cfbdd40 0378-4012 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20060301 ANDA ANDA077624 Mylan Pharmaceuticals Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-4013_30616b3c-93fd-4c54-abfa-7c9a5cfbdd40 0378-4013 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20060301 ANDA ANDA077624 Mylan Pharmaceuticals Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0378-4017_d9d8cf4c-ba73-402c-b8fe-5733cc45c7ba 0378-4017 HUMAN PRESCRIPTION DRUG Desloratadine desloratadine TABLET, FILM COATED ORAL 20120702 ANDA ANDA078351 Mylan Pharmaceuticals Inc. DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 0378-4021_8b3846a5-03b2-4742-bf0d-9954a632ed52 0378-4021 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Mylan Pharmaceuticals Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-4022_8b3846a5-03b2-4742-bf0d-9954a632ed52 0378-4022 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Mylan Pharmaceuticals Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-4024_8b3846a5-03b2-4742-bf0d-9954a632ed52 0378-4024 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Mylan Pharmaceuticals Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-4028_8b3846a5-03b2-4742-bf0d-9954a632ed52 0378-4028 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Mylan Pharmaceuticals Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-4044_923ad8d1-63d9-407e-8083-abfd685a1658 0378-4044 HUMAN PRESCRIPTION DRUG Risedronate Sodium risedronate sodium TABLET, FILM COATED ORAL 20151130 ANDA ANDA200477 Mylan Pharmaceuticals Inc. RISEDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0378-4050_591086ff-1bd4-4c1d-a5b0-b92582dc90c6 0378-4050 HUMAN PRESCRIPTION DRUG Nevirapine nevirapine TABLET ORAL 20120522 ANDA ANDA202523 Mylan Pharmaceuticals Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0378-4067_f360fa13-53fd-4fe4-bf49-f90f9f2566ed 0378-4067 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 20180331 NDA AUTHORIZED GENERIC NDA020998 Mylan Pharmaceuticals Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-4080_1967814f-cc1f-4fc5-85d9-1a44a602d1b1 0378-4080 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150826 ANDA ANDA204266 Mylan Pharmaceuticals Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4081_1967814f-cc1f-4fc5-85d9-1a44a602d1b1 0378-4081 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150826 ANDA ANDA204266 Mylan Pharmaceuticals Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4082_1967814f-cc1f-4fc5-85d9-1a44a602d1b1 0378-4082 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150826 ANDA ANDA204266 Mylan Pharmaceuticals Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4083_1967814f-cc1f-4fc5-85d9-1a44a602d1b1 0378-4083 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20151221 ANDA ANDA204266 Mylan Pharmaceuticals Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4084_1967814f-cc1f-4fc5-85d9-1a44a602d1b1 0378-4084 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20131118 ANDA ANDA202580 Mylan Pharmaceuticals Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4085_1967814f-cc1f-4fc5-85d9-1a44a602d1b1 0378-4085 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150826 ANDA ANDA204266 Mylan Pharmaceuticals Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4091_21222830-980f-4dc2-a275-bbf0d88fc084 0378-4091 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121016 20180831 ANDA ANDA200462 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0378-4093_21222830-980f-4dc2-a275-bbf0d88fc084 0378-4093 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121016 20180831 ANDA ANDA200462 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0378-4094_21222830-980f-4dc2-a275-bbf0d88fc084 0378-4094 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121016 20180831 ANDA ANDA200462 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0378-4105_17fde9d3-7eae-4969-b659-5dbcf512a298 0378-4105 HUMAN PRESCRIPTION DRUG Abacavir Sulfate abacavir sulfate TABLET, FILM COATED ORAL 20120619 ANDA ANDA091294 Mylan Pharmaceuticals Inc. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0378-4110_f05ebe8e-8143-406b-b28a-2acfb1cc029d 0378-4110 HUMAN PRESCRIPTION DRUG Felbamate felbamate TABLET ORAL 20160112 20180331 ANDA ANDA204595 Mylan Pharmaceuticals Inc. FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 0378-4111_f05ebe8e-8143-406b-b28a-2acfb1cc029d 0378-4111 HUMAN PRESCRIPTION DRUG Felbamate felbamate TABLET ORAL 20160112 20180331 ANDA ANDA204595 Mylan Pharmaceuticals Inc. FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 0378-4114_923ad8d1-63d9-407e-8083-abfd685a1658 0378-4114 HUMAN PRESCRIPTION DRUG Risedronate Sodium risedronate sodium TABLET, FILM COATED ORAL 20151130 ANDA ANDA200477 Mylan Pharmaceuticals Inc. RISEDRONATE SODIUM 30 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0378-4122_aa7abfb7-9d11-484a-801e-0ba1505e19e4 0378-4122 HUMAN PRESCRIPTION DRUG Albuterol Sulfate albuterol sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070130 ANDA ANDA078092 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0378-4124_aa7abfb7-9d11-484a-801e-0ba1505e19e4 0378-4124 HUMAN PRESCRIPTION DRUG Albuterol Sulfate albuterol sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070130 ANDA ANDA078092 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE 8 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0378-4140_a9035c66-b318-4cb1-b69d-6d3356cb9e1f 0378-4140 HUMAN PRESCRIPTION DRUG Disulfiram disulfiram TABLET ORAL 20150304 ANDA ANDA203916 Mylan Pharmaceuticals Inc. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 0378-4141_a9035c66-b318-4cb1-b69d-6d3356cb9e1f 0378-4141 HUMAN PRESCRIPTION DRUG Disulfiram disulfiram TABLET ORAL 20150304 ANDA ANDA203916 Mylan Pharmaceuticals Inc. DISULFIRAM 500 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 0378-4145_75702b86-50cd-45e7-9884-355e02aa8c8a 0378-4145 HUMAN PRESCRIPTION DRUG Riluzole riluzole TABLET, FILM COATED ORAL 20130722 ANDA ANDA203042 Mylan Pharmaceuticals Inc. RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] N 20181231 0378-4150_923ad8d1-63d9-407e-8083-abfd685a1658 0378-4150 HUMAN PRESCRIPTION DRUG Risedronate Sodium risedronate sodium TABLET, FILM COATED ORAL 20140610 ANDA ANDA200477 Mylan Pharmaceuticals Inc. RISEDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0378-4151_3c87e040-9eb2-42e1-bf38-4aaea852e2f8 0378-4151 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride tramadol hydrochloride TABLET, FILM COATED ORAL 20020621 ANDA ANDA075986 Mylan Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 0378-4152_d9972654-15ce-4359-89f1-d8a74315adb3 0378-4152 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20160316 ANDA ANDA205257 Mylan Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 0378-4153_d9972654-15ce-4359-89f1-d8a74315adb3 0378-4153 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20160316 ANDA ANDA205257 Mylan Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 0378-4154_d9972654-15ce-4359-89f1-d8a74315adb3 0378-4154 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20160316 ANDA ANDA205257 Mylan Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 0378-4160_ef47f2d2-ac21-478b-b619-b46a60781a7d 0378-4160 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20140528 ANDA ANDA202362 Mylan Pharmaceuticals Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5; 25 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 0378-4162_ef47f2d2-ac21-478b-b619-b46a60781a7d 0378-4162 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20140528 ANDA ANDA202362 Mylan Pharmaceuticals Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 0378-4201_d53e58bb-a512-4055-b4a3-8e2ac427a2ca 0378-4201 HUMAN PRESCRIPTION DRUG Mycophenolic Acid mycophenilic acid TABLET, DELAYED RELEASE ORAL 20140108 ANDA ANDA091248 Mylan Pharmaceuticals Inc. MYCOPHENOLIC ACID 180 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 0378-4202_d53e58bb-a512-4055-b4a3-8e2ac427a2ca 0378-4202 HUMAN PRESCRIPTION DRUG Mycophenolic Acid mycophenilic acid TABLET, DELAYED RELEASE ORAL 20140108 ANDA ANDA091248 Mylan Pharmaceuticals Inc. MYCOPHENOLIC ACID 360 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 0378-4230_4ea0691f-09c8-4f3c-97ce-3c3d30f01ea2 0378-4230 HUMAN PRESCRIPTION DRUG Desvenlafaxine desvenlafaxine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204095 Mylan Pharmaceuticals Inc. DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0378-4231_4ea0691f-09c8-4f3c-97ce-3c3d30f01ea2 0378-4231 HUMAN PRESCRIPTION DRUG Desvenlafaxine desvenlafaxine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204095 Mylan Pharmaceuticals Inc. DESVENLAFAXINE SUCCINATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0378-4250_573022de-0245-4b68-8341-c3ebf11031cb 0378-4250 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Mylan Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 0378-4251_2ca77e6b-7119-4c0b-b3c5-d1e23296d75d 0378-4251 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20090127 ANDA ANDA077420 Mylan Pharmaceuticals Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0378-4252_2ca77e6b-7119-4c0b-b3c5-d1e23296d75d 0378-4252 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20090127 ANDA ANDA077420 Mylan Pharmaceuticals Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0378-4253_2ca77e6b-7119-4c0b-b3c5-d1e23296d75d 0378-4253 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20090127 ANDA ANDA077420 Mylan Pharmaceuticals Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0378-4254_2ca77e6b-7119-4c0b-b3c5-d1e23296d75d 0378-4254 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20090127 ANDA ANDA077420 Mylan Pharmaceuticals Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0378-4260_55f8ba9b-7b62-45eb-9e33-2f8fc4dee996 0378-4260 HUMAN PRESCRIPTION DRUG Zolmitriptan zolmitriptan TABLET, FILM COATED ORAL 20130514 20180630 ANDA ANDA203186 Mylan Pharmaceuticals Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-4275_3115fbe1-8e08-4ca3-abd4-6ef96ae6606e 0378-4275 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA078518 Mylan Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0378-4276_3115fbe1-8e08-4ca3-abd4-6ef96ae6606e 0378-4276 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA078518 Mylan Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0378-4287_20276f5c-f2d6-469f-9a1b-aa254a1db21c 0378-4287 HUMAN PRESCRIPTION DRUG Eletriptan Hydrobromide eletriptan hydrobromide TABLET, FILM COATED ORAL 20170815 ANDA ANDA205152 Mylan Pharmaceuticals Inc. ELETRIPTAN HYDROBROMIDE 20 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-4288_20276f5c-f2d6-469f-9a1b-aa254a1db21c 0378-4288 HUMAN PRESCRIPTION DRUG Eletriptan Hydrobromide eletriptan hydrobromide TABLET, FILM COATED ORAL 20170815 ANDA ANDA205152 Mylan Pharmaceuticals Inc. ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-4390_e7ac4367-1e07-478e-9ed5-b0a77473b3ee 0378-4390 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET ORAL 20160623 ANDA ANDA204475 Mylan Pharmaceuticals Inc. FENOFIBRATE 40 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-4391_e7ac4367-1e07-478e-9ed5-b0a77473b3ee 0378-4391 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET ORAL 20160623 ANDA ANDA204475 Mylan Pharmaceuticals Inc. FENOFIBRATE 120 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-4415_cd94deec-bd31-481d-b2e5-54e98f61654a 0378-4415 HUMAN PRESCRIPTION DRUG Flurazepam Hydrochloride flurazepam hydrochloride CAPSULE ORAL 19851127 ANDA ANDA070345 Mylan Pharmaceuticals Inc. FLURAZEPAM HYDROCHLORIDE 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-4430_cd94deec-bd31-481d-b2e5-54e98f61654a 0378-4430 HUMAN PRESCRIPTION DRUG Flurazepam Hydrochloride flurazepam hydrochloride CAPSULE ORAL 19851127 ANDA ANDA070345 Mylan Pharmaceuticals Inc. FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-4472_b8acb6e8-c850-4a10-946f-05901c4be829 0378-4472 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil TABLET, FILM COATED ORAL 20090504 ANDA ANDA065521 Mylan Pharmaceuticals Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 0378-4510_f6c7aee9-febe-41e0-b83e-810e46156b28 0378-4510 HUMAN PRESCRIPTION DRUG Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140624 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-4511_f6c7aee9-febe-41e0-b83e-810e46156b28 0378-4511 HUMAN PRESCRIPTION DRUG Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140619 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-4512_f6c7aee9-febe-41e0-b83e-810e46156b28 0378-4512 HUMAN PRESCRIPTION DRUG Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20130214 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-4513_f6c7aee9-febe-41e0-b83e-810e46156b28 0378-4513 HUMAN PRESCRIPTION DRUG Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20150402 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-4514_f6c7aee9-febe-41e0-b83e-810e46156b28 0378-4514 HUMAN PRESCRIPTION DRUG Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140521 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-4515_f6c7aee9-febe-41e0-b83e-810e46156b28 0378-4515 HUMAN PRESCRIPTION DRUG Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20141016 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-4516_f6c7aee9-febe-41e0-b83e-810e46156b28 0378-4516 HUMAN PRESCRIPTION DRUG Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20141010 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 80 mg/1; mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-4517_f6c7aee9-febe-41e0-b83e-810e46156b28 0378-4517 HUMAN PRESCRIPTION DRUG Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20141106 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-4518_f6c7aee9-febe-41e0-b83e-810e46156b28 0378-4518 HUMAN PRESCRIPTION DRUG Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-4519_f6c7aee9-febe-41e0-b83e-810e46156b28 0378-4519 HUMAN PRESCRIPTION DRUG Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140211 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-4520_f6c7aee9-febe-41e0-b83e-810e46156b28 0378-4520 HUMAN PRESCRIPTION DRUG Amlodipine besylate and atorvastatin calcium Amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140521 ANDA ANDA200465 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-4531_dc54fe42-f3a2-42da-87a0-a9d529d7e313 0378-4531 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20101230 ANDA ANDA090431 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 75 mg/1 N 20181231 0378-4532_dc54fe42-f3a2-42da-87a0-a9d529d7e313 0378-4532 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20101230 ANDA ANDA090431 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0378-4533_dc54fe42-f3a2-42da-87a0-a9d529d7e313 0378-4533 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20160519 ANDA ANDA090431 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 200 mg/1 N 20181231 0378-4535_82d0b0a0-11c5-4800-ab68-f668a4781531 0378-4535 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20160523 ANDA ANDA090431 Mylan Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 0378-4541_40ccf824-cd4b-4f21-b2e5-6b233e5f6241 0378-4541 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate (monohydrate), Dextroamphetamine Sulfate, Amphetamine Sulfate dextroamphetamine, amphetamine, dextroamphetamine, amphetamine TABLET ORAL 20151110 ANDA ANDA206721 Mylan Pharmaceuticals Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4542_40ccf824-cd4b-4f21-b2e5-6b233e5f6241 0378-4542 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate (monohydrate), Dextroamphetamine Sulfate, Amphetamine Sulfate dextroamphetamine, amphetamine, dextroamphetamine, amphetamine TABLET ORAL 20151110 ANDA ANDA206721 Mylan Pharmaceuticals Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4543_40ccf824-cd4b-4f21-b2e5-6b233e5f6241 0378-4543 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate (monohydrate), Dextroamphetamine Sulfate, Amphetamine Sulfate dextroamphetamine, amphetamine, dextroamphetamine, amphetamine TABLET ORAL 20151110 ANDA ANDA206721 Mylan Pharmaceuticals Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4544_40ccf824-cd4b-4f21-b2e5-6b233e5f6241 0378-4544 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate (monohydrate), Dextroamphetamine Sulfate, Amphetamine Sulfate dextroamphetamine, amphetamine, dextroamphetamine, amphetamine TABLET ORAL 20151110 ANDA ANDA206721 Mylan Pharmaceuticals Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4545_40ccf824-cd4b-4f21-b2e5-6b233e5f6241 0378-4545 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate (monohydrate), Dextroamphetamine Sulfate, Amphetamine Sulfate dextroamphetamine, amphetamine, dextroamphetamine, amphetamine TABLET ORAL 20151110 ANDA ANDA206721 Mylan Pharmaceuticals Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4546_40ccf824-cd4b-4f21-b2e5-6b233e5f6241 0378-4546 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate (monohydrate), Dextroamphetamine Sulfate, Amphetamine Sulfate dextroamphetamine, amphetamine, dextroamphetamine, amphetamine TABLET ORAL 20151110 ANDA ANDA206721 Mylan Pharmaceuticals Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4547_40ccf824-cd4b-4f21-b2e5-6b233e5f6241 0378-4547 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate (monohydrate), Dextroamphetamine Sulfate, Amphetamine Sulfate dextroamphetamine, amphetamine, dextroamphetamine, amphetamine TABLET ORAL 20151110 ANDA ANDA206721 Mylan Pharmaceuticals Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-4560_810116bf-b10d-4fb3-b61f-09d9b072116d 0378-4560 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161109 ANDA ANDA204662 Mylan Pharmaceuticals Inc. POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0378-4561_810116bf-b10d-4fb3-b61f-09d9b072116d 0378-4561 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161109 ANDA ANDA204662 Mylan Pharmaceuticals Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0378-4593_e478b6e4-7c6c-4a8f-a68d-a00507008ef7 0378-4593 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20160329 ANDA ANDA076704 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE 37.5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-4594_e478b6e4-7c6c-4a8f-a68d-a00507008ef7 0378-4594 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20160329 ANDA ANDA076704 Mylan Pharmaceuticals Inc. METOPROLOL TARTRATE 75 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0378-4640_9e7edfd5-00cf-40c6-aefc-f564a605cd1b 0378-4640 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20141219 ANDA ANDA201675 Mylan Pharmaceuticals Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-4641_9e7edfd5-00cf-40c6-aefc-f564a605cd1b 0378-4641 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20141219 ANDA ANDA201675 Mylan Pharmaceuticals Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-4642_9e7edfd5-00cf-40c6-aefc-f564a605cd1b 0378-4642 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20141219 ANDA ANDA201675 Mylan Pharmaceuticals Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-4643_9e7edfd5-00cf-40c6-aefc-f564a605cd1b 0378-4643 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20141219 ANDA ANDA201675 Mylan Pharmaceuticals Inc. ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-4644_9e7edfd5-00cf-40c6-aefc-f564a605cd1b 0378-4644 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20141219 ANDA ANDA201675 Mylan Pharmaceuticals Inc. ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0378-4710_f6581324-a1dc-4e2e-be05-871798920dea 0378-4710 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate prednisolone TABLET, ORALLY DISINTEGRATING ORAL 20141208 ANDA ANDA202179 Mylan Pharmaceuticals Inc. PREDNISOLONE SODIUM PHOSPHATE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0378-4714_923ad8d1-63d9-407e-8083-abfd685a1658 0378-4714 HUMAN PRESCRIPTION DRUG Risedronate Sodium risedronate sodium TABLET, FILM COATED ORAL 20151130 ANDA ANDA200477 Mylan Pharmaceuticals Inc. RISEDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0378-4715_f6581324-a1dc-4e2e-be05-871798920dea 0378-4715 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate prednisolone TABLET, ORALLY DISINTEGRATING ORAL 20141208 ANDA ANDA202179 Mylan Pharmaceuticals Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0378-4725_5b743a7d-e3a9-4524-8928-c3eec397922c 0378-4725 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076688 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-4730_f6581324-a1dc-4e2e-be05-871798920dea 0378-4730 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate prednisolone TABLET, ORALLY DISINTEGRATING ORAL 20141208 ANDA ANDA202179 Mylan Pharmaceuticals Inc. PREDNISOLONE SODIUM PHOSPHATE 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0378-4735_5b743a7d-e3a9-4524-8928-c3eec397922c 0378-4735 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076688 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-4745_5b743a7d-e3a9-4524-8928-c3eec397922c 0378-4745 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076688 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-4775_5b743a7d-e3a9-4524-8928-c3eec397922c 0378-4775 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076688 Mylan Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-4791_5238fda5-c3a3-4049-8f93-323833e391eb 0378-4791 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil CREAM TOPICAL 20130723 NDA NDA016831 Mylan Pharmaceuticals Inc. FLUOROURACIL 5 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 0378-4881_a7db9b7e-8b7e-4945-a655-aad6000b7558 0378-4881 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20080614 ANDA ANDA077166 Mylan Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-4882_a7db9b7e-8b7e-4945-a655-aad6000b7558 0378-4882 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20080614 ANDA ANDA077166 Mylan Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-4883_a7db9b7e-8b7e-4945-a655-aad6000b7558 0378-4883 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20080614 ANDA ANDA077166 Mylan Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-4884_a7db9b7e-8b7e-4945-a655-aad6000b7558 0378-4884 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20080614 ANDA ANDA077166 Mylan Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-4885_a7db9b7e-8b7e-4945-a655-aad6000b7558 0378-4885 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20080614 ANDA ANDA077166 Mylan Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-4890_a6453277-4648-4b31-b8ef-4bcb452918dd 0378-4890 HUMAN PRESCRIPTION DRUG Nevirapine nevirapine TABLET, EXTENDED RELEASE ORAL 20141029 ANDA ANDA205651 Mylan Pharmaceuticals Inc. NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20191231 0378-5001_3573e3c9-ca05-413f-909f-93607a2ccb79 0378-5001 HUMAN PRESCRIPTION DRUG Exemestane exemestane TABLET, FILM COATED ORAL 20170310 ANDA ANDA203315 Mylan Pharmaceuticals Inc. EXEMESTANE 25 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0378-5005_9e59a08d-3f92-4e5e-ba66-13c7137fd683 0378-5005 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride alfuzosin TABLET, EXTENDED RELEASE ORAL 20110809 ANDA ANDA079014 Mylan Pharmaceuticals Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0378-5010_942272de-0dad-4718-bdce-b745dff16e9e 0378-5010 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19870623 ANDA ANDA071093 Mylan Pharmaceuticals Inc. THIOTHIXENE 10 mg/1 Typical Antipsychotic [EPC] N 20181231 0378-5011_7704e56c-2121-4abd-b737-162271b878c6 0378-5011 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080418 ANDA ANDA078855 Mylan Pharmaceuticals Inc. FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-5012_7704e56c-2121-4abd-b737-162271b878c6 0378-5012 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080418 ANDA ANDA078855 Mylan Pharmaceuticals Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-5013_7704e56c-2121-4abd-b737-162271b878c6 0378-5013 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080418 ANDA ANDA078855 Mylan Pharmaceuticals Inc. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-5035_e6eeb65f-daf5-4752-9d9e-108afe729aec 0378-5035 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20160725 ANDA ANDA078161 Mylan Pharmaceuticals Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 0378-5036_fe876511-c177-4f33-b5d0-f0e8177e435c 0378-5036 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20151020 ANDA ANDA077578 Mylan Pharmaceuticals Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20191231 0378-5040_b18d0296-33fa-447b-9321-8f0a48c8e5e9 0378-5040 HUMAN PRESCRIPTION DRUG Stavudine stavudine CAPSULE ORAL 20110824 ANDA ANDA079069 Mylan Pharmaceuticals Inc. STAVUDINE 15 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0378-5041_b18d0296-33fa-447b-9321-8f0a48c8e5e9 0378-5041 HUMAN PRESCRIPTION DRUG Stavudine stavudine CAPSULE ORAL 20110824 ANDA ANDA079069 Mylan Pharmaceuticals Inc. STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0378-5042_b18d0296-33fa-447b-9321-8f0a48c8e5e9 0378-5042 HUMAN PRESCRIPTION DRUG Stavudine stavudine CAPSULE ORAL 20110824 ANDA ANDA079069 Mylan Pharmaceuticals Inc. STAVUDINE 30 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0378-5043_b18d0296-33fa-447b-9321-8f0a48c8e5e9 0378-5043 HUMAN PRESCRIPTION DRUG Stavudine stavudine CAPSULE ORAL 20110824 ANDA ANDA079069 Mylan Pharmaceuticals Inc. STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0378-5050_1bdfcd1e-6e57-4d5a-9940-2fd81d487cfb 0378-5050 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19860710 ANDA ANDA070920 Mylan Pharmaceuticals Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0378-5051_88b7f8e6-c76b-4d65-b0c1-4cf8b66834dd 0378-5051 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, ORALLY DISINTEGRATING ORAL 20080918 ANDA ANDA078893 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0378-5052_88b7f8e6-c76b-4d65-b0c1-4cf8b66834dd 0378-5052 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, ORALLY DISINTEGRATING ORAL 20080918 ANDA ANDA078893 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0378-5053_88b7f8e6-c76b-4d65-b0c1-4cf8b66834dd 0378-5053 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, ORALLY DISINTEGRATING ORAL 20080918 ANDA ANDA078893 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0378-5100_ea7b6a64-baf7-4c1e-b87f-f5b2ba5ed701 0378-5100 HUMAN PRESCRIPTION DRUG Itraconazole itraconazole CAPSULE ORAL 20120726 ANDA ANDA200463 Mylan Pharmaceuticals Inc. ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-5105_fa483143-4134-428a-8379-2195b7b4787a 0378-5105 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 19961118 ANDA ANDA040185 Mylan Pharmaceuticals Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-5110_fa483143-4134-428a-8379-2195b7b4787a 0378-5110 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 19961118 ANDA ANDA040185 Mylan Pharmaceuticals Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-5121_6c7ddc97-a8f0-4043-8176-f4b25572bf1f 0378-5121 HUMAN PRESCRIPTION DRUG Fluvastatin Sodium fluvastatin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150911 ANDA ANDA202458 Mylan Pharmaceuticals Inc. FLUVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-5123_34a02845-f72e-4944-90ab-b069e10c2e59 0378-5123 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride sotalol hydrochloride TABLET ORAL 20070220 ANDA ANDA077616 Mylan Pharmaceuticals Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0378-5124_34a02845-f72e-4944-90ab-b069e10c2e59 0378-5124 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride sotalol hydrochloride TABLET ORAL 20070220 ANDA ANDA077616 Mylan Pharmaceuticals Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0378-5125_34a02845-f72e-4944-90ab-b069e10c2e59 0378-5125 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride sotalol hydrochloride TABLET ORAL 20070220 ANDA ANDA077616 Mylan Pharmaceuticals Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0378-5150_33f217b5-71b8-4773-936b-c6046b78e2a7 0378-5150 HUMAN PRESCRIPTION DRUG Nizatidine nizatidine CAPSULE ORAL 20020710 ANDA ANDA075806 Mylan Pharmaceuticals Inc. NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0378-5168_298c5026-01b0-4cd3-a144-d81bf14c0087 0378-5168 HUMAN PRESCRIPTION DRUG Lamivudine lamivudine TABLET, FILM COATED ORAL 20150109 ANDA ANDA204002 Mylan Pharmaceuticals Inc. LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0378-5169_034184e6-5084-4955-a7f6-33ada5b890ba 0378-5169 HUMAN PRESCRIPTION DRUG Lamivudine lamivudine TABLET, FILM COATED ORAL 20160328 ANDA ANDA204528 Mylan Pharmaceuticals Inc. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 0378-5170_034184e6-5084-4955-a7f6-33ada5b890ba 0378-5170 HUMAN PRESCRIPTION DRUG Lamivudine lamivudine TABLET, FILM COATED ORAL 20160328 ANDA ANDA204528 Mylan Pharmaceuticals Inc. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 0378-5180_237e7b79-e8e9-4346-b31a-9066dd18c2c0 0378-5180 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine lamivudine and zidovudine TABLET, FILM COATED ORAL 20140930 ANDA ANDA204005 Mylan Pharmaceuticals Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0378-5185_41a4e332-6725-4cb7-940a-8291cf56cfe4 0378-5185 HUMAN PRESCRIPTION DRUG Prasugrel Prasugrel TABLET, FILM COATED ORAL 20170815 ANDA ANDA205927 Mylan Pharmaceuticals Inc. PRASUGREL HYDROCHLORIDE 5 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 0378-5186_41a4e332-6725-4cb7-940a-8291cf56cfe4 0378-5186 HUMAN PRESCRIPTION DRUG Prasugrel Prasugrel TABLET, FILM COATED ORAL 20170815 ANDA ANDA205927 Mylan Pharmaceuticals Inc. PRASUGREL HYDROCHLORIDE 10 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 0378-5200_4e35b99b-6c93-47db-8fbd-f993b65daa94 0378-5200 HUMAN PRESCRIPTION DRUG Tolmetin Sodium tolmetin Sodium CAPSULE ORAL 19930527 ANDA ANDA073393 Mylan Pharmaceuticals Inc. TOLMETIN SODIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-5201_89276a38-3599-4c08-b4e7-94d54224af8a 0378-5201 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA079103 Mylan Pharmaceuticals Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0378-5204_89276a38-3599-4c08-b4e7-94d54224af8a 0378-5204 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, CHEWABLE ORAL 20120803 20190331 ANDA ANDA079142 Mylan Pharmaceuticals Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0378-5205_89276a38-3599-4c08-b4e7-94d54224af8a 0378-5205 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, CHEWABLE ORAL 20120803 20190331 ANDA ANDA079142 Mylan Pharmaceuticals Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0378-5208_7bca235f-6ada-44a6-be42-859a59b46e0c 0378-5208 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20051003 ANDA ANDA076418 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-5209_7bca235f-6ada-44a6-be42-859a59b46e0c 0378-5209 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20051003 ANDA ANDA076418 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-5210_7bca235f-6ada-44a6-be42-859a59b46e0c 0378-5210 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20051003 ANDA ANDA076418 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0378-5211_70dc5c5a-4e7e-4b1a-a440-cbedaf501e71 0378-5211 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20030804 ANDA ANDA075876 Mylan Pharmaceuticals Inc. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0378-5220_91624640-455d-4674-80e1-45f0c3acff93 0378-5220 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19980324 ANDA ANDA075124 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0378-5222_70dc5c5a-4e7e-4b1a-a440-cbedaf501e71 0378-5222 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090122 ANDA ANDA075876 Mylan Pharmaceuticals Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0378-5245_6d4a9cd4-c3e7-4fa2-ac49-b3e850a72600 0378-5245 HUMAN PRESCRIPTION DRUG Almotriptan Malate Almotriptan TABLET, FILM COATED ORAL 20151110 ANDA ANDA205171 Mylan Pharmaceuticals Inc. ALMOTRIPTAN MALATE 6.25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-5246_6d4a9cd4-c3e7-4fa2-ac49-b3e850a72600 0378-5246 HUMAN PRESCRIPTION DRUG Almotriptan Malate Almotriptan TABLET, FILM COATED ORAL 20151110 ANDA ANDA205171 Mylan Pharmaceuticals Inc. ALMOTRIPTAN MALATE 12.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-5260_a388a2cb-a70a-4299-93ac-eb59e32f4a49 0378-5260 HUMAN PRESCRIPTION DRUG Temozolomide temozolomide CAPSULE ORAL 20160629 ANDA ANDA205227 Mylan Pharmaceuticals Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0378-5261_a388a2cb-a70a-4299-93ac-eb59e32f4a49 0378-5261 HUMAN PRESCRIPTION DRUG Temozolomide temozolomide CAPSULE ORAL 20160629 ANDA ANDA205227 Mylan Pharmaceuticals Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0378-5262_a388a2cb-a70a-4299-93ac-eb59e32f4a49 0378-5262 HUMAN PRESCRIPTION DRUG Temozolomide temozolomide CAPSULE ORAL 20160629 ANDA ANDA205227 Mylan Pharmaceuticals Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0378-5263_a388a2cb-a70a-4299-93ac-eb59e32f4a49 0378-5263 HUMAN PRESCRIPTION DRUG Temozolomide temozolomide CAPSULE ORAL 20160629 ANDA ANDA205227 Mylan Pharmaceuticals Inc. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0378-5264_a388a2cb-a70a-4299-93ac-eb59e32f4a49 0378-5264 HUMAN PRESCRIPTION DRUG Temozolomide temozolomide CAPSULE ORAL 20160629 ANDA ANDA205227 Mylan Pharmaceuticals Inc. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0378-5265_a388a2cb-a70a-4299-93ac-eb59e32f4a49 0378-5265 HUMAN PRESCRIPTION DRUG Temozolomide temozolomide CAPSULE ORAL 20160629 ANDA ANDA205227 Mylan Pharmaceuticals Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0378-5270_cd31a81f-49a4-4625-baa6-6fd3ac6ff823 0378-5270 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20130326 ANDA ANDA091151 Mylan Pharmaceuticals Inc. ESZOPICLONE 1 mg/1 CIV N 20181231 0378-5271_cd31a81f-49a4-4625-baa6-6fd3ac6ff823 0378-5271 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20130326 ANDA ANDA091151 Mylan Pharmaceuticals Inc. ESZOPICLONE 2 mg/1 CIV N 20181231 0378-5272_cd31a81f-49a4-4625-baa6-6fd3ac6ff823 0378-5272 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20130326 ANDA ANDA091151 Mylan Pharmaceuticals Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 0378-5280_91624640-455d-4674-80e1-45f0c3acff93 0378-5280 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19980324 ANDA ANDA075124 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0378-5300_33f217b5-71b8-4773-936b-c6046b78e2a7 0378-5300 HUMAN PRESCRIPTION DRUG Nizatidine nizatidine CAPSULE ORAL 20020710 ANDA ANDA075806 Mylan Pharmaceuticals Inc. NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0378-5305_c56727be-2fe5-4049-b371-129b90958f5f 0378-5305 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076578 Mylan Pharmaceuticals Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0378-5310_c56727be-2fe5-4049-b371-129b90958f5f 0378-5310 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076578 Mylan Pharmaceuticals Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0378-5340_91624640-455d-4674-80e1-45f0c3acff93 0378-5340 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19980324 ANDA ANDA075124 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0378-5350_7d76d87b-47fc-4689-a118-792a15b3b940 0378-5350 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20170818 ANDA ANDA206691 Mylan Pharmaceuticals Inc. PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-5351_7d76d87b-47fc-4689-a118-792a15b3b940 0378-5351 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20170818 ANDA ANDA206691 Mylan Pharmaceuticals Inc. PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-5352_7d76d87b-47fc-4689-a118-792a15b3b940 0378-5352 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20170818 ANDA ANDA206691 Mylan Pharmaceuticals Inc. PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-5353_7d76d87b-47fc-4689-a118-792a15b3b940 0378-5353 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20170818 ANDA ANDA206691 Mylan Pharmaceuticals Inc. PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-5375_573022de-0245-4b68-8341-c3ebf11031cb 0378-5375 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Mylan Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20191231 0378-5410_3a470135-f5cd-4787-a440-034c9bf9bbf7 0378-5410 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride CAPSULE ORAL 20081117 ANDA ANDA078045 Mylan Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-5420_3a470135-f5cd-4787-a440-034c9bf9bbf7 0378-5420 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride CAPSULE ORAL 20081117 ANDA ANDA078045 Mylan Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-5475_da640701-66f8-463f-ac41-54fb80d8e447 0378-5475 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20120612 ANDA ANDA202778 Mylan Pharmaceuticals Inc. DOXYCYCLINE 150 mg/1 N 20181231 0378-5485_eb1a9eb6-a26f-4f26-aee6-1d06a4674433 0378-5485 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20120919 ANDA ANDA202640 Mylan Pharmaceuticals Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 0378-5486_eb1a9eb6-a26f-4f26-aee6-1d06a4674433 0378-5486 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20120919 ANDA ANDA202640 Mylan Pharmaceuticals Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 0378-5501_fa159fba-536d-4d23-a924-7513a81beb3c 0378-5501 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0378-5502_fa159fba-536d-4d23-a924-7513a81beb3c 0378-5502 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0378-5503_fa159fba-536d-4d23-a924-7513a81beb3c 0378-5503 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0378-5504_fa159fba-536d-4d23-a924-7513a81beb3c 0378-5504 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0378-5505_fa159fba-536d-4d23-a924-7513a81beb3c 0378-5505 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0378-5510_19413e00-ecc4-4202-9d46-de07fa3f3b4e 0378-5510 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140512 ANDA ANDA202285 Mylan Pharmaceuticals Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-5511_19413e00-ecc4-4202-9d46-de07fa3f3b4e 0378-5511 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140512 ANDA ANDA202285 Mylan Pharmaceuticals Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-5512_19413e00-ecc4-4202-9d46-de07fa3f3b4e 0378-5512 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140512 ANDA ANDA202285 Mylan Pharmaceuticals Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-5513_19413e00-ecc4-4202-9d46-de07fa3f3b4e 0378-5513 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140512 ANDA ANDA202285 Mylan Pharmaceuticals Inc. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-5521_9cef1ad9-2030-4c19-9ed8-42befa6c1b35 0378-5521 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100514 ANDA ANDA090941 Mylan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0378-5525_fa159fba-536d-4d23-a924-7513a81beb3c 0378-5525 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0378-5550_fa159fba-536d-4d23-a924-7513a81beb3c 0378-5550 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20080505 ANDA ANDA078881 Mylan Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0378-5573_a625499b-73a0-4edf-9eef-2e87e472e3fc 0378-5573 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20120810 ANDA ANDA076594 Mylan Pharmaceuticals Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 0378-5575_a625499b-73a0-4edf-9eef-2e87e472e3fc 0378-5575 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20120810 ANDA ANDA076594 Mylan Pharmaceuticals Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 0378-5613_9682b418-9e5b-4278-bca6-075b86a86f1b 0378-5613 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 Mylan Pharmaceuticals Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0378-5615_9682b418-9e5b-4278-bca6-075b86a86f1b 0378-5615 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 Mylan Pharmaceuticals Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0378-5617_9682b418-9e5b-4278-bca6-075b86a86f1b 0378-5617 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 Mylan Pharmaceuticals Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0378-5619_9682b418-9e5b-4278-bca6-075b86a86f1b 0378-5619 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20091210 ANDA ANDA090261 Mylan Pharmaceuticals Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0378-5630_dba5f450-5cff-4704-80a5-8bf815ce2a14 0378-5630 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA077744 Mylan Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-5631_dba5f450-5cff-4704-80a5-8bf815ce2a14 0378-5631 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA077744 Mylan Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-5632_dba5f450-5cff-4704-80a5-8bf815ce2a14 0378-5632 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA077744 Mylan Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0378-5807_cc739d2c-2d37-4a79-9fc0-5da9ca763b5f 0378-5807 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA090866 Mylan Pharmaceuticals Inc. VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-5813_cc739d2c-2d37-4a79-9fc0-5da9ca763b5f 0378-5813 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA090866 Mylan Pharmaceuticals Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-5814_cc739d2c-2d37-4a79-9fc0-5da9ca763b5f 0378-5814 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA090866 Mylan Pharmaceuticals Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-5815_cc739d2c-2d37-4a79-9fc0-5da9ca763b5f 0378-5815 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA090866 Mylan Pharmaceuticals Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-6001_20e236bb-e297-4f7a-9179-380f1044060e 0378-6001 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160823 ANDA ANDA200690 Mylan Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0378-6002_20e236bb-e297-4f7a-9179-380f1044060e 0378-6002 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160823 ANDA ANDA200690 Mylan Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0378-6004_215db6cf-00b7-4d20-bd54-0081ab05168e 0378-6004 HUMAN PRESCRIPTION DRUG Fluphenazine hydrochloride Fluphenazine hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 Mylan Pharmaceuticals Inc. FLUPHENAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-6009_215db6cf-00b7-4d20-bd54-0081ab05168e 0378-6009 HUMAN PRESCRIPTION DRUG Fluphenazine hydrochloride Fluphenazine hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 Mylan Pharmaceuticals Inc. FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-6021_bac100ac-2a48-470d-9320-26f1af3f31ff 0378-6021 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061117 ANDA ANDA065377 Mylan Pharmaceuticals Inc. DOXYCYCLINE 50 mg/1 N 20181231 0378-6022_bac100ac-2a48-470d-9320-26f1af3f31ff 0378-6022 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061117 ANDA ANDA065377 Mylan Pharmaceuticals Inc. DOXYCYCLINE 75 mg/1 N 20181231 0378-6023_bac100ac-2a48-470d-9320-26f1af3f31ff 0378-6023 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061117 ANDA ANDA065377 Mylan Pharmaceuticals Inc. DOXYCYCLINE 100 mg/1 N 20181231 0378-6040_89276a38-3599-4c08-b4e7-94d54224af8a 0378-6040 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium GRANULE ORAL 20130918 20180831 ANDA ANDA202776 Mylan Pharmaceuticals Inc. MONTELUKAST SODIUM 4 mg/500mg Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0378-6060_5d57c2f5-1287-4d58-98d5-b441c78e6d82 0378-6060 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19970502 ANDA ANDA074910 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0378-6074_215db6cf-00b7-4d20-bd54-0081ab05168e 0378-6074 HUMAN PRESCRIPTION DRUG Fluphenazine hydrochloride Fluphenazine hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 Mylan Pharmaceuticals Inc. FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-6088_82a8b7cb-952c-426a-b8b4-a4451c7a9fa4 0378-6088 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20130222 ANDA ANDA202579 Mylan Pharmaceuticals Inc. FENOFIBRATE 43 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-6089_82a8b7cb-952c-426a-b8b4-a4451c7a9fa4 0378-6089 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20130222 ANDA ANDA202579 Mylan Pharmaceuticals Inc. FENOFIBRATE 130 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-6090_5d57c2f5-1287-4d58-98d5-b441c78e6d82 0378-6090 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19970502 ANDA ANDA074910 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0378-6097_215db6cf-00b7-4d20-bd54-0081ab05168e 0378-6097 HUMAN PRESCRIPTION DRUG Fluphenazine hydrochloride Fluphenazine hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 Mylan Pharmaceuticals Inc. FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0378-6106_eb92f670-ccf2-428e-bc4a-8e61b472b8b4 0378-6106 HUMAN PRESCRIPTION DRUG Zidovudine zidovudine TABLET, FILM COATED ORAL 20081219 ANDA ANDA078922 Mylan Pharmaceuticals Inc. ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0378-6112_474e810b-e09a-49b9-95cd-93c23c2ca27c 0378-6112 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 20180831 ANDA ANDA091313 Mylan Pharmaceuticals Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0378-6113_474e810b-e09a-49b9-95cd-93c23c2ca27c 0378-6113 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 20180430 ANDA ANDA091313 Mylan Pharmaceuticals Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0378-6114_474e810b-e09a-49b9-95cd-93c23c2ca27c 0378-6114 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 20180531 ANDA ANDA091313 Mylan Pharmaceuticals Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0378-6120_5d57c2f5-1287-4d58-98d5-b441c78e6d82 0378-6120 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19970502 ANDA ANDA074910 Mylan Pharmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0378-6124_bac100ac-2a48-470d-9320-26f1af3f31ff 0378-6124 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20070608 ANDA ANDA065427 Mylan Pharmaceuticals Inc. DOXYCYCLINE 150 mg/1 N 20181231 0378-6140_db336b40-77d4-48d7-902e-6a2203975173 0378-6140 HUMAN PRESCRIPTION DRUG Avita Tretinoin GEL TOPICAL 19980318 NDA NDA020400 Mylan Pharmaceuticals Inc. TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0378-6141_be86af6d-9e7e-42ca-9bb2-5571c256d1f4 0378-6141 HUMAN PRESCRIPTION DRUG Avita tretinoin CREAM TOPICAL 19970601 NDA NDA020404 Mylan Pharmaceuticals Inc. TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0378-6150_70dc5c5a-4e7e-4b1a-a440-cbedaf501e71 0378-6150 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20030804 ANDA ANDA075876 Mylan Pharmaceuticals Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0378-6151_b856f519-0749-4f1d-9846-a90ff5ad0e5f 0378-6151 HUMAN PRESCRIPTION DRUG MENTAX butenafine hydrochloride CREAM TOPICAL 19961231 NDA NDA020524 Mylan Pharmaceuticals Inc. BUTENAFINE HYDROCHLORIDE 10 mg/g Benzylamine Antifungal [EPC],Benzylamines [Chemical/Ingredient] N 20181231 0378-6155_d7bc033e-9bb9-4659-9a21-a10a461cad9b 0378-6155 HUMAN PRESCRIPTION DRUG DIGITEK digoxin TABLET ORAL 20141117 ANDA ANDA040282 Mylan Pharmaceuticals Inc. DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0378-6156_d7bc033e-9bb9-4659-9a21-a10a461cad9b 0378-6156 HUMAN PRESCRIPTION DRUG DIGITEK digoxin TABLET ORAL 20141117 ANDA ANDA040282 Mylan Pharmaceuticals Inc. DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0378-6172_f967979e-13aa-4ff1-95de-df2ef507f2be 0378-6172 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20040106 ANDA ANDA076698 Mylan Pharmaceuticals Inc. METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0378-6173_f967979e-13aa-4ff1-95de-df2ef507f2be 0378-6173 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20041019 ANDA ANDA076698 Mylan Pharmaceuticals Inc. METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0378-6174_f967979e-13aa-4ff1-95de-df2ef507f2be 0378-6174 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20041019 ANDA ANDA076698 Mylan Pharmaceuticals Inc. METOLAZONE 10 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0378-6201_f92b1ec8-8247-4b1a-966e-e3e894f3414e 0378-6201 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070809 ANDA ANDA078306 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 100 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-6202_f92b1ec8-8247-4b1a-966e-e3e894f3414e 0378-6202 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070809 ANDA ANDA078306 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 200 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-6203_f92b1ec8-8247-4b1a-966e-e3e894f3414e 0378-6203 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070809 ANDA ANDA078306 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-6231_c6ab2cf3-45d6-482d-a750-a6fbbd1741d4 0378-6231 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20080728 ANDA ANDA077042 Mylan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-6232_c6ab2cf3-45d6-482d-a750-a6fbbd1741d4 0378-6232 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20080728 ANDA ANDA077042 Mylan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-6233_c6ab2cf3-45d6-482d-a750-a6fbbd1741d4 0378-6233 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20080728 ANDA ANDA077042 Mylan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-6270_a657abcb-00c2-4bea-8822-d165c6bd0871 0378-6270 HUMAN PRESCRIPTION DRUG Voriconazole voriconazole POWDER, FOR SUSPENSION ORAL 20130925 20181031 ANDA ANDA202361 Mylan Pharmaceuticals Inc. VORICONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0378-6280_ec827554-eee2-48ca-98a9-8cd0ffec44ad 0378-6280 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 20100518 ANDA ANDA075281 Mylan Pharmaceuticals Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-6281_ec827554-eee2-48ca-98a9-8cd0ffec44ad 0378-6281 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 20100518 ANDA ANDA075281 Mylan Pharmaceuticals Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-6320_5237550b-492e-45af-9be7-c0779b242356 0378-6320 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19990520 ANDA ANDA075138 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-6321_ddf1db2f-8dcb-4221-90d5-2bbb7ed2d189 0378-6321 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 ANDA ANDA078020 Mylan Pharmaceuticals Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-6322_ddf1db2f-8dcb-4221-90d5-2bbb7ed2d189 0378-6322 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 ANDA ANDA078020 Mylan Pharmaceuticals Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-6323_ddf1db2f-8dcb-4221-90d5-2bbb7ed2d189 0378-6323 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 ANDA ANDA078020 Mylan Pharmaceuticals Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-6324_ddf1db2f-8dcb-4221-90d5-2bbb7ed2d189 0378-6324 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 ANDA ANDA078020 Mylan Pharmaceuticals Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-6325_ddf1db2f-8dcb-4221-90d5-2bbb7ed2d189 0378-6325 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 ANDA ANDA078020 Mylan Pharmaceuticals Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0378-6333_68e8bb7d-f8d1-464b-9471-78ea43732c99 0378-6333 HUMAN PRESCRIPTION DRUG Acamprosate Calcium acamprosate calcium enteric-coated TABLET, DELAYED RELEASE ORAL 20140924 ANDA ANDA200142 Mylan Pharmaceuticals Inc. ACAMPROSATE CALCIUM 333 mg/1 N 20181231 0378-6380_5237550b-492e-45af-9be7-c0779b242356 0378-6380 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19990520 ANDA ANDA075138 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-6410_573022de-0245-4b68-8341-c3ebf11031cb 0378-6410 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Mylan Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20191231 0378-6440_5237550b-492e-45af-9be7-c0779b242356 0378-6440 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19990520 ANDA ANDA075138 Mylan Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-6510_530f8ec6-4dd5-4343-90ef-a407e3bac6f7 0378-6510 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075451 Mylan Pharmaceuticals Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-6520_530f8ec6-4dd5-4343-90ef-a407e3bac6f7 0378-6520 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075451 Mylan Pharmaceuticals Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-6540_530f8ec6-4dd5-4343-90ef-a407e3bac6f7 0378-6540 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075451 Mylan Pharmaceuticals Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-6550_0b48cd13-4eaa-472e-93c9-344220448779 0378-6550 HUMAN PRESCRIPTION DRUG LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol and levonorgestrel KIT 20130816 ANDA ANDA091663 Mylan Pharmaceuticals Inc. N 20181231 0378-6605_094c94ab-63ba-4ff2-9f83-6f6134153517 0378-6605 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061110 ANDA ANDA076702 Mylan Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0378-6610_094c94ab-63ba-4ff2-9f83-6f6134153517 0378-6610 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061110 ANDA ANDA076644 Mylan Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0378-6611_4776ee01-d684-4ca5-861c-7a1c303fad59 0378-6611 HUMAN PRESCRIPTION DRUG Amnesteem isotretinoin CAPSULE ORAL 20170630 ANDA ANDA075945 Mylan Pharmaceuticals Inc. ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0378-6612_4776ee01-d684-4ca5-861c-7a1c303fad59 0378-6612 HUMAN PRESCRIPTION DRUG Amnesteem isotretinoin CAPSULE ORAL 20170630 ANDA ANDA075945 Mylan Pharmaceuticals Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0378-6614_4776ee01-d684-4ca5-861c-7a1c303fad59 0378-6614 HUMAN PRESCRIPTION DRUG Amnesteem isotretinoin CAPSULE ORAL 20170630 ANDA ANDA075945 Mylan Pharmaceuticals Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0378-6615_094c94ab-63ba-4ff2-9f83-6f6134153517 0378-6615 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151203 ANDA ANDA076644 Mylan Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0378-6629_e7c67baa-202a-416c-8938-43f542027c56 0378-6629 HUMAN PRESCRIPTION DRUG Eprosartan Mesylate eprosartan mesylate TABLET, FILM COATED ORAL 20111220 ANDA ANDA202012 Mylan Pharmaceuticals Inc. EPROSARTAN MESYLATE 600 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-6688_5ac97761-7b00-4cf1-8b93-36c77ff4d57a 0378-6688 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA090970 Mylan Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 0378-6689_5ac97761-7b00-4cf1-8b93-36c77ff4d57a 0378-6689 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA090970 Mylan Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 0378-6709_470eca6b-3701-4a9b-97f3-abdee3226d12 0378-6709 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium rabeprazole TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA076885 Mylan Pharmaceuticals Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 0378-6725_50416dc6-95f2-44e4-a109-c7992580e978 0378-6725 HUMAN PRESCRIPTION DRUG Zonisamide zonisamide CAPSULE ORAL 20051223 ANDA ANDA077637 Mylan Pharmaceuticals Inc. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-6726_50416dc6-95f2-44e4-a109-c7992580e978 0378-6726 HUMAN PRESCRIPTION DRUG Zonisamide zonisamide CAPSULE ORAL 20051223 ANDA ANDA077637 Mylan Pharmaceuticals Inc. ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-6727_50416dc6-95f2-44e4-a109-c7992580e978 0378-6727 HUMAN PRESCRIPTION DRUG Zonisamide zonisamide CAPSULE ORAL 20051223 ANDA ANDA077637 Mylan Pharmaceuticals Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0378-6895_8106621c-b8f9-4603-b5b0-3d1375d8ee39 0378-6895 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride amlodipine and benazepril hydrochloride CAPSULE ORAL 20120220 ANDA ANDA077375 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-6896_8106621c-b8f9-4603-b5b0-3d1375d8ee39 0378-6896 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride amlodipine and benazepril hydrochloride CAPSULE ORAL 20120220 ANDA ANDA077375 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-6897_8106621c-b8f9-4603-b5b0-3d1375d8ee39 0378-6897 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride amlodipine benazepril hydrochloride CAPSULE ORAL 20120220 ANDA ANDA077375 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-6898_8106621c-b8f9-4603-b5b0-3d1375d8ee39 0378-6898 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride amlodipine and benazepril hydrochloride CAPSULE ORAL 20120220 ANDA ANDA077375 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-6899_8106621c-b8f9-4603-b5b0-3d1375d8ee39 0378-6899 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride amlodipine and benazepril hydrochloride CAPSULE ORAL 20120220 ANDA ANDA079047 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-6900_8106621c-b8f9-4603-b5b0-3d1375d8ee39 0378-6900 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride amlodipine and benazepril hydrochloride CAPSULE ORAL 20120220 ANDA ANDA079047 Mylan Pharmaceuticals Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0378-6950_a6453277-4648-4b31-b8ef-4bcb452918dd 0378-6950 HUMAN PRESCRIPTION DRUG Nevirapine nevirapine TABLET, EXTENDED RELEASE ORAL 20151109 ANDA ANDA206271 Mylan Pharmaceuticals Inc. NEVIRAPINE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20191231 0378-6955_2d1eb4bd-51f9-4c9b-9fb1-0be5e30a3dc5 0378-6955 HUMAN PRESCRIPTION DRUG Bexarotene Bexarotene CAPSULE, LIQUID FILLED ORAL 20150709 ANDA ANDA203174 Mylan Pharmaceuticals Inc. BEXAROTENE 75 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0378-6960_f38b5606-d2d7-44ec-912f-46882aa2fa7b 0378-6960 HUMAN PRESCRIPTION DRUG Glatiramer Acetate glatiramer acetate INJECTION, SOLUTION SUBCUTANEOUS 20171004 ANDA ANDA091646 Mylan Pharmaceuticals Inc. GLATIRAMER ACETATE 20 mg/mL N 20181231 0378-6961_456a34c7-8511-4000-99a7-ad8f8de6d35e 0378-6961 HUMAN PRESCRIPTION DRUG Glatiramer Acetate Glatiramer INJECTION, SOLUTION SUBCUTANEOUS 20171004 ANDA ANDA206936 Mylan Pharmaceuticals Inc. GLATIRAMER ACETATE 40 mg/mL N 20181231 0378-6991_c1b43b4b-6687-4473-bae3-95f927675910 0378-6991 HUMAN PRESCRIPTION DRUG Albuterol Sulfate albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20091030 NDA AUTHORIZED GENERIC NDA020949 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE .75 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0378-6992_c1b43b4b-6687-4473-bae3-95f927675910 0378-6992 HUMAN PRESCRIPTION DRUG Albuterol Sulfate albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20091030 NDA AUTHORIZED GENERIC NDA020949 Mylan Pharmaceuticals Inc. ALBUTEROL SULFATE 1.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0378-6993_a0043338-b518-4a01-aa5b-c7bb6e34ddf4 0378-6993 HUMAN PRESCRIPTION DRUG Levalbuterol levalbuterol SOLUTION, CONCENTRATE RESPIRATORY (INHALATION) 20090828 ANDA ANDA078309 Mylan Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0378-7001_9b2128cf-3650-4f24-9d95-522355a63f0d 0378-7001 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-7002_9b2128cf-3650-4f24-9d95-522355a63f0d 0378-7002 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-7003_9b2128cf-3650-4f24-9d95-522355a63f0d 0378-7003 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-7004_9b2128cf-3650-4f24-9d95-522355a63f0d 0378-7004 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 Mylan Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0378-7005_5aa3ffc7-efc7-42e8-8cfc-b154721474ff 0378-7005 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041103 ANDA ANDA076762 Mylan Pharmaceuticals Inc. LOXAPINE SUCCINATE 5 mg/1 N 20181231 0378-7010_5aa3ffc7-efc7-42e8-8cfc-b154721474ff 0378-7010 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041103 ANDA ANDA076762 Mylan Pharmaceuticals Inc. LOXAPINE SUCCINATE 10 mg/1 N 20181231 0378-7012_95d7a7f9-42b0-447a-b976-39f6e6a4a716 0378-7012 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20161026 ANDA ANDA078276 Mylan Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-7020_5e79418b-d55f-473c-b8b7-afc59aa6772e 0378-7020 HUMAN PRESCRIPTION DRUG Acitretin acitretin CAPSULE ORAL 20160310 ANDA ANDA202148 Mylan Pharmaceuticals Inc. ACITRETIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0378-7023_5e79418b-d55f-473c-b8b7-afc59aa6772e 0378-7023 HUMAN PRESCRIPTION DRUG Acitretin acitretin CAPSULE ORAL 20160310 ANDA ANDA202148 Mylan Pharmaceuticals Inc. ACITRETIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0378-7025_5aa3ffc7-efc7-42e8-8cfc-b154721474ff 0378-7025 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041103 ANDA ANDA076762 Mylan Pharmaceuticals Inc. LOXAPINE SUCCINATE 25 mg/1 N 20181231 0378-7050_5aa3ffc7-efc7-42e8-8cfc-b154721474ff 0378-7050 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041103 ANDA ANDA076762 Mylan Pharmaceuticals Inc. LOXAPINE SUCCINATE 50 mg/1 N 20181231 0378-7077_746beaa1-9f99-4c94-8cf8-fd327e02e12c 0378-7077 HUMAN PRESCRIPTION DRUG Linezolid linezolid TABLET, FILM COATED ORAL 20151221 ANDA ANDA078845 Mylan Pharmaceuticals Inc. LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0378-7096_4af5d2ca-f09e-4311-9db9-a9457d8bf01b 0378-7096 HUMAN PRESCRIPTION DRUG Bromocriptine Mesylate bromocriptine mesylate CAPSULE ORAL 20130617 ANDA ANDA077226 Mylan Pharmaceuticals Inc. BROMOCRIPTINE MESYLATE 5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 0378-7098_6900e31e-17bc-47d4-bf20-42e090a1e23f 0378-7098 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20090309 20211231 ANDA ANDA075817 Mylan Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0378-7100_e5c692b2-ce20-4f46-83bc-fac05e7cf058 0378-7100 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20091222 ANDA ANDA076520 Mylan Pharmaceuticals Inc. FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-7101_e5c692b2-ce20-4f46-83bc-fac05e7cf058 0378-7101 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20091222 ANDA ANDA076520 Mylan Pharmaceuticals Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-7103_ec908615-d7bb-4d96-ae0b-e4639f6ee842 0378-7103 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20081216 20180731 ANDA ANDA090177 Mylan Pharmaceuticals Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-7104_ec908615-d7bb-4d96-ae0b-e4639f6ee842 0378-7104 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20081216 20181231 ANDA ANDA090177 Mylan Pharmaceuticals Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-7105_ec908615-d7bb-4d96-ae0b-e4639f6ee842 0378-7105 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20081216 20180930 ANDA ANDA090177 Mylan Pharmaceuticals Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-7106_ec908615-d7bb-4d96-ae0b-e4639f6ee842 0378-7106 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20081216 20180331 ANDA ANDA090177 Mylan Pharmaceuticals Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-7112_95d7a7f9-42b0-447a-b976-39f6e6a4a716 0378-7112 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20161026 ANDA ANDA078276 Mylan Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-7124_95d7a7f9-42b0-447a-b976-39f6e6a4a716 0378-7124 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20161026 ANDA ANDA078276 Mylan Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0378-7150_812e9727-86b6-4276-8668-61dfe5c60700 0378-7150 HUMAN PRESCRIPTION DRUG Celecoxib celecoxib CAPSULE ORAL 20150415 ANDA ANDA078857 Mylan Pharmaceuticals Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-7155_4e74dbbe-8634-447b-8a93-ce18defbaf32 0378-7155 HUMAN PRESCRIPTION DRUG Budesonide budesonide CAPSULE ORAL 20110516 ANDA ANDA090410 Mylan Pharmaceuticals Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0378-7160_812e9727-86b6-4276-8668-61dfe5c60700 0378-7160 HUMAN PRESCRIPTION DRUG Celecoxib celecoxib CAPSULE ORAL 20151123 ANDA ANDA078857 Mylan Pharmaceuticals Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-7165_812e9727-86b6-4276-8668-61dfe5c60700 0378-7165 HUMAN PRESCRIPTION DRUG Celecoxib celecoxib CAPSULE ORAL 20150623 ANDA ANDA078857 Mylan Pharmaceuticals Inc. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-7170_812e9727-86b6-4276-8668-61dfe5c60700 0378-7170 HUMAN PRESCRIPTION DRUG Celecoxib celecoxib CAPSULE ORAL 20151123 ANDA ANDA078857 Mylan Pharmaceuticals Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0378-7180_c70efdc7-584b-4cb6-ac22-32f0b5637530 0378-7180 HUMAN PRESCRIPTION DRUG Quinine Sulfate quinine sulfate CAPSULE ORAL 20121214 ANDA ANDA202581 Mylan Pharmaceuticals Inc. QUININE SULFATE 324 mg/1 Antimalarial [EPC] N 20181231 0378-7185_d41a85a9-3765-4b46-b3c5-355946754455 0378-7185 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20100603 ANDA ANDA075973 Mylan Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0378-7186_d41a85a9-3765-4b46-b3c5-355946754455 0378-7186 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20100603 ANDA ANDA075973 Mylan Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0378-7187_d41a85a9-3765-4b46-b3c5-355946754455 0378-7187 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20100603 ANDA ANDA075973 Mylan Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0378-7272_dcc81f04-856f-46a8-998a-288a394d0092 0378-7272 HUMAN PRESCRIPTION DRUG Norethindrone Norethindrone TABLET ORAL 20130624 ANDA ANDA200980 Mylan Pharmaceuticals Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0378-7277_d3700234-3f76-4dd5-b91c-b88411cb4d89 0378-7277 HUMAN PRESCRIPTION DRUG NORGESTIMATE AND ETHINYL ESTRADIOL norgestimate and ethinyl estradiol KIT 20151231 ANDA ANDA202132 Mylan Pharmaceuticals Inc. N 20181231 0378-7280_f3e1605d-89b7-49c7-aa16-ed49efb1a005 0378-7280 HUMAN PRESCRIPTION DRUG NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL norethindrone acetate and ethinyl estradiol TABLET ORAL 20140711 ANDA ANDA202771 Mylan Pharmaceuticals Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .02; 1 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0378-7281_07e83b96-aad7-480e-abe8-0ef238d1c09a 0378-7281 HUMAN PRESCRIPTION DRUG LEVONORGESTREL AND ETHINYL ESTRADIOL Levonorgestrel and Ethinyl Estradiol KIT 20150427 ANDA ANDA200490 Mylan Pharmaceuticals Inc. N 20181231 0378-7282_f5961b26-22c7-46c4-b25e-3ad508d722ba 0378-7282 HUMAN PRESCRIPTION DRUG DESOGESTREL AND ETHINYL ESTRADIOL desogestrel and ethinyl estradiol KIT 20170629 ANDA ANDA202085 Mylan Pharmaceuticals Inc. N 20181231 0378-7283_d272ef38-bb6d-4687-801f-92874f750666 0378-7283 HUMAN PRESCRIPTION DRUG NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL norethindrone acetate and ethinyl estradiol KIT 20140716 ANDA ANDA202772 Mylan Pharmaceuticals Inc. N 20181231 0378-7284_63d834c5-3601-41a9-89cd-c1a3df4428d2 0378-7284 HUMAN PRESCRIPTION DRUG LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol KIT 20161107 ANDA ANDA200493 Mylan Pharmaceuticals Inc. N 20181231 0378-7285_06764d28-4bb7-41d3-b692-6d1bc783a14a 0378-7285 HUMAN PRESCRIPTION DRUG LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL levonorgestrel and ethinyl estradiol and ethinyl estradiol KIT 20150528 ANDA ANDA200492 Mylan Pharmaceuticals Inc. N 20181231 0378-7287_2468ec54-fc78-493a-86b6-5da9823867f4 0378-7287 HUMAN PRESCRIPTION DRUG LEVONORGESTREL AND ETHINYL ESTRADIOL Levonorgestrel and Ethinyl Estradiol KIT 20140626 ANDA ANDA200245 Mylan Pharmaceuticals Inc. N 20181231 0378-7292_60a13d29-ae6d-48f9-83b3-b686f61d11c9 0378-7292 HUMAN PRESCRIPTION DRUG Norethindrone Norethindrone TABLET ORAL 20130712 ANDA ANDA201483 Mylan Pharmaceuticals Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0378-7296_e7af9ce2-8b4d-4ae6-b2bd-5d8f4da21a46 0378-7296 HUMAN PRESCRIPTION DRUG DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL desogestrel and ethinyl estradiol and ethinyl estradiol KIT 20140716 ANDA ANDA202296 Mylan Pharmaceuticals Inc. N 20181231 0378-7297_7458d31b-41a3-44f9-8940-2f8833af0ae8 0378-7297 HUMAN PRESCRIPTION DRUG NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE norethindrone and ethinyl estradiol and ferrous fumarate KIT 20161028 ANDA ANDA202086 Mylan Pharmaceuticals Inc. N 20181231 0378-7298_9cb65de9-87a7-4e9e-b756-25049628c299 0378-7298 HUMAN PRESCRIPTION DRUG LEVONORGESTREL AND ETHINYL ESTRADIOL levonorgestrel and ethinyl estradiol KIT 20150420 ANDA ANDA202247 Mylan Pharmaceuticals Inc. N 20181231 0378-7300_b44c68b5-d0be-48b7-9cb8-8b91944326a8 0378-7300 HUMAN PRESCRIPTION DRUG DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone and ethinyl estradiol KIT 20150828 ANDA ANDA202131 Mylan Pharmaceuticals Inc. N 20181231 0378-7301_6ab67aec-82b5-41fb-bde3-442b79142703 0378-7301 HUMAN PRESCRIPTION DRUG NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE norethindrone acetate and ethinyl estradiol and ferrous fumarate KIT 20141030 ANDA ANDA202742 Mylan Pharmaceuticals Inc. N 20181231 0378-7306_e5d0f9b2-7099-4302-9e80-4f2f2d9d7b03 0378-7306 HUMAN PRESCRIPTION DRUG ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ethynodiol diacetate and ethinyl estradiol KIT 20161130 ANDA ANDA204704 Mylan Pharmaceuticals Inc. N 20181231 0378-7307_2c2aaa2f-85cf-4a37-82da-1e076443ad43 0378-7307 HUMAN PRESCRIPTION DRUG ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ethynodiol diacetate and ethinyl estradiol KIT 20170919 ANDA ANDA204703 Mylan Pharmaceuticals Inc. N 20181231 0378-7308_ec18a584-38a3-4704-a575-c710cc7a262e 0378-7308 HUMAN PRESCRIPTION DRUG NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE norethindrone and ethinyl estradiol and ferrous fumarate KIT 20150401 ANDA ANDA203371 Mylan Pharmaceuticals Inc. N 20181231 0378-7315_7971f9b1-2234-4d63-85c8-bdf5e95351b4 0378-7315 HUMAN PRESCRIPTION DRUG NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE norethindrone acetate and ethinyl estradiol and ferrous fumarate KIT 20170913 ANDA ANDA206120 Mylan Pharmaceuticals Inc. N 20181231 0378-7316_291a3a95-0356-4b9b-94f3-33066d4bf183 0378-7316 HUMAN PRESCRIPTION DRUG LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL levonorgestrel and ethinyl estradiol and ethinyl estradiol KIT 20171002 ANDA ANDA206053 Mylan Pharmaceuticals Inc. N 20181231 0378-7351_6279bfee-a9a4-4dd8-a226-c0b96a350158 0378-7351 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140624 20180228 ANDA ANDA202395 Mylan Pharmaceuticals Inc. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-7352_6279bfee-a9a4-4dd8-a226-c0b96a350158 0378-7352 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140624 20180228 ANDA ANDA202395 Mylan Pharmaceuticals Inc. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-7353_6279bfee-a9a4-4dd8-a226-c0b96a350158 0378-7353 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140624 20180630 ANDA ANDA202395 Mylan Pharmaceuticals Inc. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 0378-7732_f785ac33-9648-432a-b875-6fceb3fb7f6b 0378-7732 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070625 ANDA ANDA078139 Mylan Pharmaceuticals Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0378-7734_f785ac33-9648-432a-b875-6fceb3fb7f6b 0378-7734 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070625 ANDA ANDA078139 Mylan Pharmaceuticals Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0378-7970_041ea50d-a1ff-422a-af3a-fff0e2a483c5 0378-7970 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20101109 ANDA ANDA075693 Mylan Pharmaceuticals, Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0378-8011_1e8362ef-eb43-40bf-87a7-cd27865117da 0378-8011 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20130529 ANDA ANDA078626 Mylan Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0378-8015_23205516-de4e-47a3-94ff-dd44fa946773 0378-8015 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20091110 ANDA ANDA090763 Mylan Pharmaceuticals Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 0378-8020_1c1a4abe-9621-49ae-a0e7-a35ae390532c 0378-8020 HUMAN PRESCRIPTION DRUG Fluvastatin Sodium fluvastatin CAPSULE ORAL 20130319 ANDA ANDA090595 Mylan Pharmaceuticals Inc. FLUVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-8021_1c1a4abe-9621-49ae-a0e7-a35ae390532c 0378-8021 HUMAN PRESCRIPTION DRUG Fluvastatin Sodium fluvastatin CAPSULE ORAL 20130319 ANDA ANDA090595 Mylan Pharmaceuticals Inc. FLUVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0378-8030_23205516-de4e-47a3-94ff-dd44fa946773 0378-8030 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20091110 ANDA ANDA090763 Mylan Pharmaceuticals Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 0378-8088_a037348d-17e8-4c9d-9d31-475e0cbf7d1d 0378-8088 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen tramadol hydrochloride and acetaminophen TABLET, FILM COATED ORAL 20081124 ANDA ANDA077858 Mylan Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 0378-8115_8c2758c7-b7fa-435c-935d-3bad88e2fb9c 0378-8115 HUMAN PRESCRIPTION DRUG Methamphetamine Hydrochloride Methamphetamine Hydrochloride TABLET ORAL 20100426 20181031 ANDA ANDA091189 Mylan Pharmaceuticals Inc. METHAMPHETAMINE HYDROCHLORIDE 5 mg/1 Amphetamine Anorectic [EPC],Amphetamines [Chemical/Ingredient],Appetite Suppression [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE] CII N 20181231 0378-8121_1e8362ef-eb43-40bf-87a7-cd27865117da 0378-8121 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20130529 ANDA ANDA078626 Mylan Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0378-8127_1e8362ef-eb43-40bf-87a7-cd27865117da 0378-8127 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20120518 ANDA ANDA078626 Mylan Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0378-8155_d00434e0-62ef-4cb6-8e15-f31e3da7a170 0378-8155 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161229 ANDA ANDA206726 Mylan Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-8156_d00434e0-62ef-4cb6-8e15-f31e3da7a170 0378-8156 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161229 ANDA ANDA206726 Mylan Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-8157_d00434e0-62ef-4cb6-8e15-f31e3da7a170 0378-8157 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161229 ANDA ANDA206726 Mylan Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-8158_d00434e0-62ef-4cb6-8e15-f31e3da7a170 0378-8158 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161229 ANDA ANDA206726 Mylan Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0378-8180_1faf8d75-af60-4438-b6d5-c1b06d5ac703 0378-8180 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate AEROSOL, FOAM TOPICAL 20170425 NDA AUTHORIZED GENERIC NDA020934 Mylan Pharmaceuticals Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0378-8190_9efa7854-0ad6-401e-a4dd-b2f88e5182f4 0378-8190 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20170913 ANDA ANDA075057 Mylan Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0378-8200_7dfae966-a583-41d9-b867-1bb6981af597 0378-8200 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE, EXTENDED RELEASE ORAL 20030904 ANDA ANDA075679 Mylan Pharmaceuticals Inc. KETOPROFEN 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 0378-8270_e4a10741-a10f-4d9f-a98c-c8c168cf433a 0378-8270 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20121015 ANDA ANDA077839 Mylan Pharmaceuticals, Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0378-8300_6e07ee7a-b1ab-464f-89cf-594799b7cd97 0378-8300 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20150212 NDA AUTHORIZED GENERIC NDA021485 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA; ENTACAPONE 12.5; 50; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0378-8301_6e07ee7a-b1ab-464f-89cf-594799b7cd97 0378-8301 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20131028 NDA AUTHORIZED GENERIC NDA021485 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA; ENTACAPONE 18.75; 75; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0378-8302_6e07ee7a-b1ab-464f-89cf-594799b7cd97 0378-8302 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20131028 NDA AUTHORIZED GENERIC NDA021485 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA; ENTACAPONE 25; 100; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0378-8303_6e07ee7a-b1ab-464f-89cf-594799b7cd97 0378-8303 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20131028 NDA AUTHORIZED GENERIC NDA021485 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA; ENTACAPONE 31.25; 125; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0378-8304_6e07ee7a-b1ab-464f-89cf-594799b7cd97 0378-8304 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20131028 NDA AUTHORIZED GENERIC NDA021485 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA; ENTACAPONE 37.5; 150; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0378-8305_6e07ee7a-b1ab-464f-89cf-594799b7cd97 0378-8305 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa and Entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20131028 NDA AUTHORIZED GENERIC NDA021485 Mylan Pharmaceuticals Inc. CARBIDOPA; LEVODOPA; ENTACAPONE 50; 200; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0378-8628_3f489a2f-b57f-4aad-9002-235af7422f80 0378-8628 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20121023 ANDA ANDA202676 Mylan Pharmaceuticals Inc. FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-8629_3f489a2f-b57f-4aad-9002-235af7422f80 0378-8629 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20121023 ANDA ANDA202676 Mylan Pharmaceuticals Inc. FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-8630_3f489a2f-b57f-4aad-9002-235af7422f80 0378-8630 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20121023 ANDA ANDA202676 Mylan Pharmaceuticals Inc. FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 0378-8688_8a8675ae-261d-4f90-853e-fb1022d72202 0378-8688 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate and Benzoyl Peroxide clindamycin phosphate and benzoyl peroxide KIT 20090825 ANDA ANDA065443 Mylan Pharmaceuticals Inc. N 20181231 0378-8700_e5277128-206b-4562-9513-c208f490bea8 0378-8700 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir OINTMENT TOPICAL 20130403 ANDA ANDA202459 Mylan Pharmaceuticals Inc. ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0378-8730_9a4280ee-f5a0-4a6e-8571-16d421dafc7a 0378-8730 HUMAN PRESCRIPTION DRUG Clindamycin Palmitate Hydrochloride Clindamycin GRANULE, FOR SOLUTION ORAL 20160526 20181130 ANDA ANDA203063 Mylan Pharmaceuticals Inc. CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0378-8770_98770987-b313-4f2a-9aac-db0ab2068cc6 0378-8770 HUMAN PRESCRIPTION DRUG Estradiol Estradiol CREAM VAGINAL 20171229 ANDA ANDA208788 Mylan Pharmaceuticals Inc. ESTRADIOL .1 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20191231 0378-8880_14378bd7-cc09-44a5-8db7-5690926b8b9b 0378-8880 HUMAN OTC DRUG Loratadine loratadine TABLET ORAL 20130327 ANDA ANDA076154 Mylan Pharmaceuticals Inc. LORATADINE 10 mg/1 N 20181231 0378-9040_af3df753-5346-4c68-869a-eac79a887e39 0378-9040 HUMAN PRESCRIPTION DRUG Cystagon cysteamine bitartrate CAPSULE ORAL 19940815 NDA NDA020392 Mylan Pharmaceuticals Inc. CYSTEAMINE BITARTRATE 50 mg/1 Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] N 20181231 0378-9045_af3df753-5346-4c68-869a-eac79a887e39 0378-9045 HUMAN PRESCRIPTION DRUG Cystagon cysteamine bitartrate CAPSULE ORAL 19940815 NDA NDA020392 Mylan Pharmaceuticals Inc. CYSTEAMINE BITARTRATE 150 mg/1 Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] N 20181231 0378-9055_349ac48c-adc8-4343-8b52-b18bf2a37969 0378-9055 HUMAN PRESCRIPTION DRUG Lidocaine lidocaine PATCH CUTANEOUS 20150807 ANDA ANDA202346 Mylan Pharmaceuticals Inc. LIDOCAINE 140 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0378-9080_f8949e0c-d4c8-4c4b-9cc6-8fa9462462bf 0378-9080 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20130626 NDA AUTHORIZED GENERIC NDA020796 Mylan Pharmaceuticals Inc. ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0378-9102_c911b5fd-1cf0-4196-b0dd-4a4c245dc8a9 0378-9102 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin PATCH TRANSDERMAL 19980618 ANDA ANDA074559 Mylan Pharmaceuticals Inc. NITROGLYCERIN .1 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0378-9104_c911b5fd-1cf0-4196-b0dd-4a4c245dc8a9 0378-9104 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin PATCH TRANSDERMAL 19960830 ANDA ANDA074559 Mylan Pharmaceuticals Inc. NITROGLYCERIN .2 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0378-9112_c911b5fd-1cf0-4196-b0dd-4a4c245dc8a9 0378-9112 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin PATCH TRANSDERMAL 19960830 ANDA ANDA074559 Mylan Pharmaceuticals Inc. NITROGLYCERIN .4 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0378-9116_c911b5fd-1cf0-4196-b0dd-4a4c245dc8a9 0378-9116 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin PATCH TRANSDERMAL 19960830 ANDA ANDA074559 Mylan Pharmaceuticals Inc. NITROGLYCERIN .6 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0378-9119_b701ea25-1009-46f1-9609-37cd2dacef3f 0378-9119 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20070123 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 12 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-9121_b701ea25-1009-46f1-9609-37cd2dacef3f 0378-9121 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20050131 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-9122_b701ea25-1009-46f1-9609-37cd2dacef3f 0378-9122 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20050131 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-9123_b701ea25-1009-46f1-9609-37cd2dacef3f 0378-9123 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20050131 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-9124_b701ea25-1009-46f1-9609-37cd2dacef3f 0378-9124 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20050131 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-9125_b701ea25-1009-46f1-9609-37cd2dacef3f 0378-9125 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20150226 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 37.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-9126_b701ea25-1009-46f1-9609-37cd2dacef3f 0378-9126 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20150226 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 62.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-9127_b701ea25-1009-46f1-9609-37cd2dacef3f 0378-9127 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20150226 ANDA ANDA076258 Mylan Pharmaceuticals Inc. FENTANYL 87.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0378-9290_d70a70e6-f87c-46ef-9667-e86ad8d60a09 0378-9290 HUMAN PRESCRIPTION DRUG Selegiline Hydrochloride selegiline hydrochloride TABLET ORAL 20100308 ANDA ANDA074866 Mylan Pharmaceuticals Inc. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 0378-9639_3d68b3d8-82c8-417f-9453-2ec617db936a 0378-9639 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate butorphanol tartrate SPRAY NASAL 20110121 ANDA ANDA075759 Mylan Pharmaceuticals Inc. BUTORPHANOL TARTRATE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV N 20181231 0378-9671_5fb07c03-37cf-5192-e053-2a91aa0a4775 0378-9671 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20130301 ANDA ANDA202496 Mylan Pharmaceuticals, Inc. IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 2.5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0378-9680_fef5b01c-618e-4a12-8435-dfd818a0d22a 0378-9680 HUMAN PRESCRIPTION DRUG Levalbuterol levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130315 ANDA ANDA077800 Mylan Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0378-9681_fef5b01c-618e-4a12-8435-dfd818a0d22a 0378-9681 HUMAN PRESCRIPTION DRUG Levalbuterol levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130315 ANDA ANDA077800 Mylan Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0378-9682_fef5b01c-618e-4a12-8435-dfd818a0d22a 0378-9682 HUMAN PRESCRIPTION DRUG Levalbuterol levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130315 ANDA ANDA077800 Mylan Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0389-0486_28e9a429-d774-42bc-be06-b4c74f71627c 0389-0486 HUMAN PRESCRIPTION DRUG Ascorbic Acid Ascorbic Acid INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19990601 UNAPPROVED DRUG OTHER The Torrance Company ASCORBIC ACID 500 mg/mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20191231 0395-0040_619286c6-8295-8c29-e053-2a91aa0abc80 0395-0040 HUMAN OTC DRUG Ethyl Rubbing Alcohol Alcohol LIQUID TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. ALCOHOL 700 mg/mL N 20181231 0395-0073_5d925912-6594-18f2-e053-2a91aa0aa1bf 0395-0073 HUMAN OTC DRUG Humco Aromatic Ammonia Spirit Ammonia 2% LIQUID TOPICAL 20080101 UNAPPROVED DRUG OTHER Humco Holding Group, Inc. AMMONIA 20 mg/mL N 20181231 0395-0098_5d92a7f4-81a0-4489-e053-2991aa0a0b5d 0395-0098 HUMAN OTC DRUG HUMCO Ear Drops for Swimmers Isopropyl Alcohol LIQUID AURICULAR (OTIC) 20080101 OTC MONOGRAPH FINAL part344 Humco Holding Group, Inc. ISOPROPYL ALCOHOL 950 mg/mL N 20181231 0395-0115_5d92d3b2-ee4a-51fb-e053-2a91aa0add63 0395-0115 HUMAN OTC DRUG Arnica Arnica LIQUID TOPICAL 19970101 UNAPPROVED HOMEOPATHIC Humco Holding Group, Inc. ARNICA MONTANA FLOWER 200 mg/mL N 20181231 0395-0119_604fda97-cb16-13eb-e053-2991aa0aa452 0395-0119 HUMAN OTC DRUG Ivy Wash Pramoxine Hydrochloride LOTION TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Humco Holding Group, Inc. PRAMOXINE HYDROCHLORIDE 10 1/mL N 20181231 0395-0127_5d92e31e-b87f-969b-e053-2991aa0a5cd3 0395-0127 HUMAN OTC DRUG Asafetida Asafetida LIQUID TOPICAL 19970101 UNAPPROVED HOMEOPATHIC Humco Holding Group, Inc. ASAFETIDA 200 mg/mL N 20181231 0395-0129_5d92e69a-6047-639d-e053-2a91aa0a096e 0395-0129 HUMAN OTC DRUG Castiva Cooling Menthol and Methyl Salicylate CREAM TOPICAL 20061201 OTC MONOGRAPH NOT FINAL part348 Humco Holding Group, Inc. MENTHOL; METHYL SALICYLATE 50; 140 mg/g; mg/g N 20181231 0395-0130_5d932670-f691-073e-e053-2991aa0ae091 0395-0130 HUMAN OTC DRUG Castiva Warming Capsaicin CREAM TOPICAL 20061201 OTC MONOGRAPH NOT FINAL part348 Humco Holding Group, Inc. CAPSAICIN .35 mg/g N 20181231 0395-0243_5fd84834-2e92-4745-e053-2991aa0a1c15 0395-0243 HUMAN OTC DRUG Benzoin Compound Tincture Benzoin Resin LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part356 Humco Holding Group, Inc. BENZOIN RESIN 1000 mg/mL N 20181231 0395-0247_5da677d2-7842-2dca-e053-2991aa0a94c1 0395-0247 HUMAN OTC DRUG Benzoin Tincture Benzoin Resin LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part356 Humco Holding Group, Inc. BENZOIN RESIN 1000 mg/mL N 20181231 0395-0400_5da68878-c8a5-c27f-e053-2a91aa0a9e3a 0395-0400 HUMAN OTC DRUG Humco Calaclear Pramoxine Hydrochloride and Zinc Acetate LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Humco Holding Group, Inc. PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 0395-0407_5dde5fde-424d-4349-e053-2a91aa0a82e5 0395-0407 HUMAN OTC DRUG Calamine Phenolated Topical Suspension Calamine and Zinc Oxide and Phenol LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Humco Holding Group, Inc ZINC OXIDE; PHENOL 160; 10 mg/mL; mg/mL N 20181231 0395-0413_5e097970-de50-d9cf-e053-2991aa0a2dd0 0395-0413 HUMAN OTC DRUG Humco Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Humco holding Group, Inc. ZINC OXIDE 160 mg/mL N 20181231 0395-0420_5dde91ea-345d-7d99-e053-2a91aa0a8ed3 0395-0420 HUMAN OTC DRUG Humco Calagesic Calamine and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Humco Holding Group, Inc. ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 0395-0431_5dde91ea-346c-7d99-e053-2a91aa0a8ed3 0395-0431 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate POWDER ORAL 20080101 OTC MONOGRAPH FINAL part331 Humco Holding Group, Inc. CALCIUM CARBONATE 1 g/g N 20181231 0395-0467_d1c1b1a8-979a-464a-b355-263a0942356c 0395-0467 HUMAN OTC DRUG HUMCO Camphor Spirit Camphor 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Humco Holding Group, Inc. CAMPHOR (NATURAL) 100 mg/mL N 20181231 0395-0513_5a8c8534-ade0-452b-a178-029ef78dfad7 0395-0513 HUMAN OTC DRUG Humco Castor Oil (Regular) Castor Oil LIQUID ORAL 20130101 OTC MONOGRAPH NOT FINAL part334 Humco Holding Group, Inc. CASTOR OIL 1 mg/mL N 20181231 0395-0515_5ddedd5b-211d-5a18-e053-2a91aa0affbe 0395-0515 HUMAN OTC DRUG Humco Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 Humco holding Group, Inc. CASTOR OIL 1 mg/mL N 20181231 0395-0527_5dded11d-b5bb-39ce-e053-2991aa0a3116 0395-0527 HUMAN OTC DRUG Humco Charcoal Activated Activated Charcoal POWDER ORAL 20080101 UNAPPROVED DRUG OTHER Humco Holding Group. Inc. ACTIVATED CHARCOAL 1000 mg/g N 20181231 0395-0713_5fc791ef-167a-f4e7-e053-2a91aa0acad1 0395-0713 HUMAN OTC DRUG Humco Dewees Carminative Magnesium Carbonate SUSPENSION ORAL 19980325 OTC MONOGRAPH FINAL part331 Humco Holding Group, inc. MAGNESIUM CARBONATE 50 mg/mL N 20181231 0395-0807_5de38a03-3a62-2bcc-e053-2a91aa0a3ba6 0395-0807 HUMAN OTC DRUG Humco Epson Salt Magnesium Sulfate POWDER, FOR SOLUTION ORAL 19980325 OTC MONOGRAPH NOT FINAL part334 Humco Holding Group, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 1000 mg/g N 20181231 0395-1003_5de3b05e-9855-64ec-e053-2a91aa0a7636 0395-1003 HUMAN OTC DRUG Humco Gentian Violet 1% Gentian Violet 1% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. GENTIAN VIOLET 10 mg/mL N 20181231 0395-1005_5de3b05e-9871-64ec-e053-2a91aa0a7636 0395-1005 HUMAN OTC DRUG Humco Gentian Violet 2% Gentian Violet 2% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. GENTIAN VIOLET 20 mg/mL N 20181231 0395-1037_5de3d4b3-2697-94b0-e053-2a91aa0a56f0 0395-1037 HUMAN OTC DRUG Humco Glycerin and Artificial Rose Water Glycerin LIQUID TOPICAL 19980325 OTC MONOGRAPH FINAL part346 Humco Holding Group, Inc. GLYCERIN 100 mg/mL N 20181231 0395-1113_5d9579bf-101a-a41e-e053-2a91aa0ab9ac 0395-1113 HUMAN OTC DRUG Humco Hydrogen Peroxide Hydrogen Peroxide 3% LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. HYDROGEN PEROXIDE 30 mg/mL N 20181231 0395-1207_5f9b8853-f8c3-3326-e053-2991aa0aa54d 0395-1207 HUMAN OTC DRUG Humco Iodides Tincture Ethyl Alcohol LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. ALCOHOL .45 mL/mL N 20181231 0395-1211_5de3ef99-cdc1-b650-e053-2a91aa0a4799 0395-1211 HUMAN OTC DRUG HUMCO 1 Percent Iodine Isopropyl Alcohol LIQUID TOPICAL 20170608 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. ISOPROPYL ALCOHOL 700 mg/mL N 20181231 0395-1213_609e8d07-6af3-2ad3-e053-2a91aa0aa876 0395-1213 HUMAN OTC DRUG Iodine Tincture Mild Iodine and Sodium Iodide and Alcohol LIQUID TOPICAL 19790101 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 0395-1219_5d93562d-f691-c699-e053-2a91aa0aec3b 0395-1219 HUMAN OTC DRUG Humco Strong Iodine Tincture Iodine Tincture LIQUID TOPICAL 19980325 20210731 OTC MONOGRAPH NOT FINAL part333A Humo Holding Group, Inc. IODINE; POTASSIUM IODIDE; ALCOHOL 70; 50; 850 mg/mL; mg/mL; mg/mL N 20181231 0395-1220_5d9340bf-91fc-7f15-e053-2a91aa0a1195 0395-1220 HUMAN OTC DRUG Strong Iodine Tincture Iodine Tincture LIQUID TOPICAL 20171109 OTC MONOGRAPH NOT FINAL part333A Humo Holding Group, Inc. ALCOHOL 850 mg/mL N 20181231 0395-1249_5df235cd-ff11-b3e3-e053-2a91aa0af4da 0395-1249 HUMAN OTC DRUG HUMCO Isopropyl Rubbing Alcohol 70% Isopropyl Alcohol LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. ISOPROPYL ALCOHOL 700 mg/mL N 20181231 0395-1667_5df25635-32b4-d6f3-e053-2a91aa0a3c21 0395-1667 HUMAN OTC DRUG Humco Wintergreen Oil Methyl Salicylate LIQUID TOPICAL 19980325 20211031 OTC MONOGRAPH NOT FINAL part348 Humco Holding Group, Inc. METHYL SALICYLATE 980 mg/mL N 20181231 0395-1670_5df235cd-ff23-b3e3-e053-2a91aa0af4da 0395-1670 HUMAN OTC DRUG Humco Milk of Magnesia Magnesium Hydroxide SUSPENSION ORAL 19980325 OTC MONOGRAPH FINAL part331 Humco Holding Group, Inc. MAGNESIUM HYDROXIDE 80 mg/mL N 20181231 0395-1673_5df2a968-77b5-0424-e053-2a91aa0af507 0395-1673 HUMAN OTC DRUG Humco Mineral Oil Light Mineral Oil LIQUID TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Humco Holding Group, Inc. MINERAL OIL 1000 mg/mL N 20181231 0395-1685_5df2b7bc-b81f-2de0-e053-2a91aa0a010a 0395-1685 HUMAN OTC DRUG Humco Mineral Oil Heavy Mineral Oil LIQUID ORAL 19980325 OTC MONOGRAPH NOT FINAL part334 Humco Holding Group, Inc. MINERAL OIL 1000 mg/mL N 20181231 0395-2075_aeddb109-a2ba-4c20-a04c-b67351846eac 0395-2075 HUMAN OTC DRUG Humco Turpentine Oil Rectified Turpentine LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part348 Humco Holding Group, Inc. TURPENTINE 1000 mg/mL N 20181231 0395-2325_61922977-4bfb-680b-e053-2a91aa0afcc7 0395-2325 HUMAN OTC DRUG Humco Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. POVIDONE-IODINE 100 mg/mL N 20181231 0395-2649_5df319f7-6108-7ae1-e053-2a91aa0a7671 0395-2649 HUMAN OTC DRUG Humco Senna Leaves Senna Leaves EXTRACT ORAL 19980325 OTC MONOGRAPH NOT FINAL part334 Humco Holding Group, Inc. SENNOSIDES A AND B 1000 mg/g N 20181231 0395-2685_5fb43cce-7777-4775-e053-2991aa0a44a1 0395-2685 HUMAN OTC DRUG Humco Sodium Bicarbonate Sodium Bicarbonate POWDER ORAL 19980325 OTC MONOGRAPH FINAL part331 Humco Holding Group, Inc. SODIUM BICARBONATE 1000 mg/g N 20181231 0395-2775_402598c4-5e96-4f2c-9469-6f07d988956b 0395-2775 HUMAN PRESCRIPTION DRUG HUMCO Strong Iodine Iodine and potassium iodide LIQUID ORAL 20080101 UNAPPROVED DRUG OTHER Humco Holding Group, Inc IODINE; POTASSIUM IODIDE 50; 100 mg/mL; mg/mL N 20181231 0395-3213_5df3d019-925c-41e4-e053-2a91aa0a190f 0395-3213 HUMAN OTC DRUG Humco Witch Hazel Witch Hazel LIQUID TOPICAL 20120201 OTC MONOGRAPH FINAL part347 Humco Holding Group, Inc. WITCH HAZEL 884 mg/mL N 20181231 0395-4202_60505adb-14d6-1bb6-e053-2a91aa0a3494 0395-4202 HUMAN OTC DRUG HUMCO Isopropyl Rubbing Alcohol 70% Professional Pack Isopropyl Alcohol LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. ISOPROPYL ALCOHOL 700 mg/mL N 20181231 0395-4209_6050143b-def5-65eb-e053-2a91aa0ad999 0395-4209 HUMAN OTC DRUG Benzoin Compound Tincture Professional Pack Benzoin Resin LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part356 Humco Holding Group, Inc. BENZOIN RESIN 1000 mg/mL N 20181231 0395-6110_238e4311-81cd-47d9-e054-00144ff8d46c 0395-6110 HUMAN PRESCRIPTION DRUG Lidocaine-Prilocaine-Cream Base Lidocaine-Prilocaine-Cream Base CREAM TOPICAL 20151020 UNAPPROVED DRUG OTHER Humco Holding Group, Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0395-6120_29e55730-b8da-4e38-8d1a-670fa1721249 0395-6120 HUMAN PRESCRIPTION DRUG Diclofenac Sodium 3 Percent diclofenac sodium CREAM TOPICAL 20160601 UNAPPROVED DRUG OTHER Humco Holding Group, Inc DICLOFENAC SODIUM 300 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0395-8010_5df2da99-bd59-1679-e053-2a91aa0a98cc 0395-8010 HUMAN OTC DRUG HUMCO Merthiolate Benzalkonium Chloride LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 0395-9112_6053abc4-06a7-5dcd-e053-2991aa0ac318 0395-9112 HUMAN OTC DRUG Camphor Spirit Camphor 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Humco Holding Group, Inc. CAMPHOR (NATURAL) 100 mg/mL N 20181231 0395-9113_6053d4d2-5966-19e0-e053-2991aa0a819a 0395-9113 HUMAN OTC DRUG Humco Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 Humco Holding Group, Inc. CASTOR OIL 1 mg/mL N 20181231 0395-9117_6062fd98-7662-f4b5-e053-2a91aa0acbc3 0395-9117 HUMAN OTC DRUG Iodides Tincture Ethyl Alcohol LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. ALCOHOL .45 mL/mL N 20181231 0395-9119_6063e651-b307-c671-e053-2a91aa0adbd0 0395-9119 HUMAN OTC DRUG Isopropyl Alcohol 91 Percent isopropyl alcohol LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Humco Holding Group, Inc. ISOPROPYL ALCOHOL 910 mg/mL N 20181231 0404-0001_bf12f971-9147-4044-b1e4-da087e63672e 0404-0001 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Henry Schein Inc. HYDROGEN PEROXIDE 30 mg/mL N 20181231 0404-0002_6e948da5-b176-42a8-9e8f-e2f598670248 0404-0002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Henry Schein Inc. ISOPROPYL ALCOHOL 700 mg/mL N 20181231 0404-0007_885fa69c-b578-4ab6-9927-f3c0ba4e8e8b 0404-0007 HUMAN OTC DRUG Alcohol Prep Pads Isopropyl Alcohol SWAB TOPICAL 20151027 OTC MONOGRAPH NOT FINAL part333A Henry Schein, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 0404-0008_8ad5d54c-9700-45b9-b205-51afbaeaf010 0404-0008 HUMAN OTC DRUG Henry Schein Flexible Unna Boot Zinc Oxide DRESSING TOPICAL 20160606 OTC MONOGRAPH FINAL part347 Henry Schein, Inc. ZINC OXIDE 25 g/1 E 20171231 0404-0009_eb044a42-2791-40ab-8863-408b92f168aa 0404-0009 HUMAN OTC DRUG Henry Schein Flexible Unna Boot Zinc Oxide DRESSING TOPICAL 20160606 OTC MONOGRAPH FINAL part347 Henry Schein, Inc. ZINC OXIDE 25 g/1 E 20171231 0404-0010_fbab769b-31f3-4d23-9b3e-56195ef423f6 0404-0010 HUMAN OTC DRUG Henry Schein Flexible Unna Boot with Calamine Zinc Oxide, Calamine DRESSING TOPICAL 20160727 OTC MONOGRAPH FINAL part347 Henry Schein, Inc. ZINC OXIDE; FERRIC OXIDE RED 25.985; .015 g/1; g/1 E 20171231 0404-0011_9bc69799-0327-4c8c-9db4-0f47bb14c684 0404-0011 HUMAN OTC DRUG Henry Schein Flexible Unna Boot with Calamine Zinc Oxide, Calamine DRESSING TOPICAL 20160727 OTC MONOGRAPH FINAL part347 Henry Schein, Inc. ZINC OXIDE; FERRIC OXIDE RED 25.985; .015 g/1; g/1 E 20171231 0404-0017_4a65ef18-0ed6-0789-e054-00144ff88e88 0404-0017 HUMAN OTC DRUG Henry Schein Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151215 ANDA ANDA075010 Henry Schein Inc. IBUPROFEN 200 mg/1 N 20181231 0404-0018_1d9c6f83-3ffd-4b59-af3f-ccb805178d9f 0404-0018 HUMAN OTC DRUG Benzo Jel Benzocaine SPRAY, METERED DENTAL 20160201 OTC MONOGRAPH NOT FINAL part356 Henry Schein Inc. BENZOCAINE 11.4 g/57g N 20181231 0404-0032_131ff05e-120a-406f-ae3a-68e3a4e09c94 0404-0032 HUMAN OTC DRUG Benzo-Jel Benzocaine GEL DENTAL 20160501 OTC MONOGRAPH NOT FINAL part356 Henry Schein Inc. BENZOCAINE 200 mg/g N 20181231 0404-0033_5fc7bd21-fe28-4d16-a47c-b23c47e24b51 0404-0033 HUMAN OTC DRUG Benzo-Jel Benzocaine GEL DENTAL 20160501 OTC MONOGRAPH NOT FINAL part356 Henry Schein Inc. BENZOCAINE 200 mg/g N 20181231 0404-0034_2aca8c95-1b77-4d32-8814-a38d68670a98 0404-0034 HUMAN OTC DRUG Benzo-Jel Benzocaine GEL DENTAL 20160501 OTC MONOGRAPH NOT FINAL part356 Henry Schein Inc. BENZOCAINE 200 mg/g N 20181231 0404-0035_33162e8a-6494-40fd-aa3e-ec8c8eb49b71 0404-0035 HUMAN OTC DRUG Benzo-Jel Benzocaine GEL DENTAL 20160501 OTC MONOGRAPH NOT FINAL part356 Henry Schein Inc. BENZOCAINE 200 mg/g N 20181231 0404-0036_fa4cc55a-d4de-4b98-befc-89486047031d 0404-0036 HUMAN OTC DRUG Benzo-Jel Benzocaine GEL DENTAL 20160501 OTC MONOGRAPH NOT FINAL part356 Henry Schein Inc. BENZOCAINE 200 mg/g N 20181231 0404-0037_739ea740-9f93-4fa7-a986-9856fe480d15 0404-0037 HUMAN OTC DRUG Benzo-Jel Benzocaine GEL DENTAL 20160501 OTC MONOGRAPH NOT FINAL part356 Henry Schein Inc. BENZOCAINE 200 mg/g N 20181231 0404-0038_c0b9d21e-e3bd-415f-99fd-fc10e76abdeb 0404-0038 HUMAN OTC DRUG Benzo-Jel Benzocaine GEL DENTAL 20160501 OTC MONOGRAPH NOT FINAL part356 Henry Schein Inc. BENZOCAINE 200 mg/g N 20181231 0404-0039_467c495d-4316-4752-8a83-97dc7930eafd 0404-0039 HUMAN OTC DRUG Benzo-Jel Benzocaine GEL DENTAL 20160501 OTC MONOGRAPH NOT FINAL part356 Henry Schein Inc. BENZOCAINE 200 mg/g N 20181231 0404-0042_37c42290-1d38-4da2-b86d-985046e52072 0404-0042 HUMAN OTC DRUG Petrolatum petrolatum OINTMENT TOPICAL 20110405 OTC MONOGRAPH FINAL part347 Henry Schein, Inc. PETROLATUM 1 g/g N 20181231 0404-0360_1709e179-b561-49d2-90cb-ceb54f090179 0404-0360 HUMAN OTC DRUG Schein Triple Antibiotic neomycin sulfate, polymyxin b Sulfate, bacitracin zinc OINTMENT TOPICAL 20150421 OTC MONOGRAPH FINAL part333B Henry Schein, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 5000; 400 mg/g; [iU]/g; [iU]/g N 20181231 0404-0370_1d183479-6c18-45b2-aa12-0fd741738bfa 0404-0370 HUMAN OTC DRUG Schein Hydrocortisone hydrocortisone CREAM TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part348 Henry Schein, Inc. HYDROCORTISONE 10 mg/g N 20181231 0404-0375_a23245c6-1a41-4ca5-930b-d4c394e4d112 0404-0375 HUMAN OTC DRUG A and D Petrolatum OINTMENT TOPICAL 20111204 OTC MONOGRAPH FINAL part347 Henry Schein, Inc. PETROLATUM 937.5 mg/g N 20181231 0404-0400_17d4fb4e-4b19-4817-b84e-9178258361dd 0404-0400 HUMAN OTC DRUG Schein Bacitracin BACITRACIN ZINC OINTMENT TOPICAL 20111204 OTC MONOGRAPH FINAL part333B Henry Schein, Inc. BACITRACIN ZINC 500 [iU]/g N 20181231 0404-0436_2020a3e0-1a75-49fa-bd1a-8a43ae879cc2 0404-0436 HUMAN PRESCRIPTION DRUG Benzo-Jel Mint Benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER Henry Schein Inc BENZOCAINE 230 mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 0404-0712_4aa04c7a-e4c2-6082-e054-00144ff8d46c 0404-0712 HUMAN OTC DRUG Henry Schein Aspirin Aspirin TABLET, FILM COATED ORAL 20110725 OTC MONOGRAPH FINAL part343 Henry Schein, Inc. ASPIRIN 325 mg/1 N 20181231 0404-0714_1003d693-0141-6183-e054-00144ff88e88 0404-0714 HUMAN OTC DRUG Henry Schein Acetaminophen Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Henry Schein, Inc. ACETAMINOPHEN 325 mg/1 N 20181231 0404-0716_139d28d6-e179-2ca4-e054-00144ff8d46c 0404-0716 HUMAN OTC DRUG Henry Schein Acetaminophen Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Henry Schein, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 0404-0741_b8ecf21f-3c0c-2144-9964-b688cdcd2e10 0404-0741 HUMAN PRESCRIPTION DRUG Benzo-Jel Benzocaine GEL TOPICAL 20150703 UNAPPROVED DRUG OTHER Henry Schein, Inc. BENZOCAINE 200 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 0404-0742_b8ecf21f-3c0c-2144-9964-b688cdcd2e10 0404-0742 HUMAN PRESCRIPTION DRUG Benzo-Jel Benzocaine GEL TOPICAL 20150703 UNAPPROVED DRUG OTHER Henry Schein, Inc. BENZOCAINE 200 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 0404-0743_b8ecf21f-3c0c-2144-9964-b688cdcd2e10 0404-0743 HUMAN PRESCRIPTION DRUG Benzo-Jel Benzocaine GEL TOPICAL 20150703 UNAPPROVED DRUG OTHER Henry Schein, Inc. BENZOCAINE 200 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 0404-1000_b9103fda-8d7d-4b59-9fa1-64e32ac66575 0404-1000 HUMAN PRESCRIPTION DRUG STYPTSTIX SILVER NITRATE APPLICATOR STICK TOPICAL 20140601 UNAPPROVED DRUG OTHER Henry Schein Inc. SILVER NITRATE; POTASSIUM NITRATE 38.21; 12.74 mg/1; mg/1 N 20181231 0404-1080_bac98ca9-ab1e-4867-9ef6-236642898675 0404-1080 HUMAN PRESCRIPTION DRUG Topical Hemo-Stat Aluminum Chloride SOLUTION DENTAL 19630219 UNAPPROVED DRUG OTHER Henry Schein ALUMINUM CHLORIDE 250 mg/g E 20171231 0404-1993_2918a715-2869-41bd-8165-56d3eafba9f2 0404-1993 HUMAN PRESCRIPTION DRUG Benzo-Jel STRAWBERRY Benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER Henry Schein Inc BENZOCAINE 230 mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 0404-3099_5c35bbaf-1e02-4f90-9a38-1d78b15feb3a 0404-3099 HUMAN PRESCRIPTION DRUG Benzo-Jel Pina Colada Benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER Henry Schein Inc BENZOCAINE 230 mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 0404-3339_4967da0b-eb48-279b-e054-00144ff8d46c 0404-3339 HUMAN PRESCRIPTION DRUG Acclean 60 Second Fluoride Treatment Fluoride GEL DENTAL 20170303 UNAPPROVED DRUG OTHER Henry Schein Inc. SODIUM FLUORIDE .0272 g/mL N 20181231 0404-3416_75566fd9-461f-4f06-bb64-2ef6bca44f74 0404-3416 HUMAN PRESCRIPTION DRUG Benzo-Jel Raspberry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Henry Schein, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 0404-3963_496786d3-5280-104d-e054-00144ff88e88 0404-3963 HUMAN PRESCRIPTION DRUG Acclean 60 Second Fluoride Treatment Fluoride GEL DENTAL 20170303 UNAPPROVED DRUG OTHER Henry Schein Inc. SODIUM FLUORIDE .0272 g/mL N 20181231 0404-4075_466078d0-f4b0-2c07-e054-00144ff8d46c 0404-4075 HUMAN PRESCRIPTION DRUG Acclean Chlorhexidine Gluconate 0.12% Oral Rinse Chlorhexidine Gluconate 0.12% Oral Rinse LIQUID ORAL 20091001 ANDA ANDA077789 Henry Schein, Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 0404-4438_8d0f604a-b9ef-4c01-85c3-5f7d6d93528e 0404-4438 HUMAN OTC DRUG Antibacterial Hand chloroxylenol SOAP TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part333A Henry Schein, Inc. CHLOROXYLENOL 6.1 g/L N 20181231 0404-4441_bc93fdd6-b5d2-46f7-a0b5-fe49d5ce4b7f 0404-4441 HUMAN OTC DRUG Antibacterial chloroxylenol LIQUID TOPICAL 20130131 OTC MONOGRAPH NOT FINAL part333A Henry Schein, Inc. CHLOROXYLENOL 6.046 g/L N 20181231 0404-4445_1a133c7c-aba0-4011-8213-3d889737d502 0404-4445 HUMAN OTC DRUG Hand Sanitizer benzalkonium chloride LIQUID TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part333E Henry Schein, Inc. BENZALKONIUM CHLORIDE 7.49 g/L N 20181231 0404-4447_4967da0b-eb4c-279b-e054-00144ff8d46c 0404-4447 HUMAN PRESCRIPTION DRUG Acclean 60 Second Fluoride Treatment Fluoride GEL DENTAL 20170303 UNAPPROVED DRUG OTHER Henry Schein Inc. SODIUM FLUORIDE .0272 g/mL N 20181231 0404-4448_4967da0b-eb4a-279b-e054-00144ff8d46c 0404-4448 HUMAN PRESCRIPTION DRUG Acclean 60 Second Fluoride Treatment 1.23% APF Fluoride GEL DENTAL 20170303 UNAPPROVED DRUG OTHER Henry Schein Inc SODIUM FLUORIDE .0272 g/mL N 20181231 0404-5637_66e953a6-6da4-4aad-8758-4a020abaad56 0404-5637 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20110317 OTC MONOGRAPH FINAL part333C Henry Schein Inc POVIDONE-IODINE 10 mL/100mL N 20181231 0404-5638_481480de-fc66-4fdf-9b12-76341d0e1974 0404-5638 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20110317 OTC MONOGRAPH FINAL part333C Henry Schein Inc POVIDONE-IODINE 10 mL/100mL N 20181231 0404-5639_490c1272-43db-4fe6-88f7-27f83e75ea59 0404-5639 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20110317 OTC MONOGRAPH FINAL part333C Henry Schein Inc POVIDONE-IODINE 10 mL/100mL N 20181231 0404-5676_4967cd4a-3763-4e18-e054-00144ff8d46c 0404-5676 HUMAN PRESCRIPTION DRUG Acclean 60 Second Fluoride Treatment Fluoride GEL DENTAL 20170303 UNAPPROVED DRUG OTHER Henry Schein Inc. SODIUM FLUORIDE .0272 g/mL N 20181231 0404-5824_47424e29-8f84-450e-9f13-89a130394660 0404-5824 HUMAN OTC DRUG BZK Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20111005 OTC MONOGRAPH NOT FINAL part333A Henry Schein Inc. BENZALKONIUM CHLORIDE .001 mL/1.4mL N 20181231 0404-5987_46177116-56b5-4d6a-aaa7-d32954b4270c 0404-5987 HUMAN OTC DRUG Antimicrobial Hand Wash Chloroxylenol SOAP TOPICAL 20120207 OTC MONOGRAPH NOT FINAL part333A Henry Schein, Inc. CHLOROXYLENOL 6 mg/1000mL N 20181231 0404-5988_380f0f50-a4fe-44f5-b48f-b9879212fd22 0404-5988 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20120207 OTC MONOGRAPH NOT FINAL part333E Henry Schein, Inc. ALCOHOL 665 mL/1000mL N 20181231 0404-5990_2175033d-2201-4e33-86ee-600fac438d58 0404-5990 HUMAN OTC DRUG Antimicrobial Hand Wash Chloroxylenol SOAP TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333A Henry Schein, Inc. CHLOROXYLENOL 6 mg/1000mL N 20181231 0404-5991_cdf7e25f-de59-4638-823f-119e20890f21 0404-5991 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Henry Schein, Inc. ALCOHOL 665 mL/1000mL N 20181231 0404-6500_b2934ce0-fcfb-4c29-a489-cceb86dd4edf 0404-6500 HUMAN PRESCRIPTION DRUG LIDOCAINE Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088389 Henry Schein Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .02 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0404-6512_5850f34f-ae95-4d1b-bc5f-eb9d0fe410df 0404-6512 HUMAN PRESCRIPTION DRUG LIDOCAINE Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20170915 ANDA ANDA088390 Henry Schein LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0404-6512_df1e14c9-1cd7-4d5f-8a82-45eb96c0df12 0404-6512 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 Henry Scein Inc LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0404-6620_1a4721e9-5240-4d30-9d80-c16763ec6fec 0404-6620 HUMAN PRESCRIPTION DRUG Articaine Hydrochloride and Epinephrine Articaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20150128 NDA NDA020971 Henry Schein ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0404-6620_fa9cdde9-8336-4c87-a787-ff62a5b4ecd5 0404-6620 HUMAN PRESCRIPTION DRUG Articaine Hydrochloride and Epinephrine Articaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20161212 NDA NDA020971 Henry Schein ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0404-6625_1a4721e9-5240-4d30-9d80-c16763ec6fec 0404-6625 HUMAN PRESCRIPTION DRUG Articaine Hydrochloride and Epinephrine Articaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20140128 NDA NDA020971 Henry Schein ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0404-6720_3cf34d92-6f0a-4650-e054-00144ff8d46c 0404-6720 HUMAN PRESCRIPTION DRUG Acclean Chlorhexidine Gluconate 0.12% Oral Rinse Chlorhexidine Gluconate 0.12% Oral Rinse LIQUID ORAL 20130201 ANDA ANDA077789 Henry Schein, Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 0404-6730_281b81d6-0255-4f98-b3c4-05caa7faaa7f 0404-6730 HUMAN PRESCRIPTION DRUG Mepivacaine Hydrochloride Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088387 Henry Schein Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0404-6730_dc674c9d-25db-4f73-b200-0d55ab8c4fe4 0404-6730 HUMAN PRESCRIPTION DRUG Mepivacaine Hydrochloride Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20170915 ANDA ANDA088387 Henry Schein Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0404-6735_c41742ae-2bb7-4014-9448-000665a033d4 0404-6735 HUMAN OTC DRUG BZK benzalkonium chloride LIQUID TOPICAL 20130107 OTC MONOGRAPH NOT FINAL part333E Henry Schein Inc. BENZALKONIUM CHLORIDE .0013 g/g N 20181231 0404-6740_281b81d6-0255-4f98-b3c4-05caa7faaa7f 0404-6740 HUMAN PRESCRIPTION DRUG Mepivacaine Hydrochloride with Levonordefrin Mepivacaine Hydrochloride and Levonordefrin INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088388 Henry Schein Inc. MEPIVACAINE HYDROCHLORIDE; LEVONORDEFRIN 20; .05 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0404-6918_f7d139dc-8c9f-a925-0dc7-3249a02dd555 0404-6918 HUMAN PRESCRIPTION DRUG Acclean Plus Sodium Flouride GEL, DENTIFRICE ORAL 20140415 UNAPPROVED DRUG OTHER Henry Schein, Inc. SODIUM FLUORIDE 11 mg/g E 20171231 0404-6919_f7d139dc-8c9f-a925-0dc7-3249a02dd555 0404-6919 HUMAN PRESCRIPTION DRUG Acclean Plus Sodium Flouride GEL, DENTIFRICE ORAL 20140415 UNAPPROVED DRUG OTHER Henry Schein, Inc. SODIUM FLUORIDE 11 mg/g E 20171231 0404-7187_99ab15f2-4805-4468-bef6-b97d73c621a6 0404-7187 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20150513 ANDA ANDA076555 Henry Schein Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0404-7189_3fc21b59-1737-4e42-8e35-98eb9256a4d3 0404-7189 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20150513 ANDA ANDA076407 Henry Schein Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0404-7191_01fcaba9-df08-41d6-9b5d-6888a2d4cc9d 0404-7191 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20150513 ANDA ANDA064030 Henry Schein Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0404-7192_e1d00465-8d56-434b-8dde-10315c979f7f 0404-7192 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 20150513 ANDA ANDA040315 Henry Schein Inc. TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0404-7194_bfccc073-978b-4584-bdc2-852eb9920249 0404-7194 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 20150513 ANDA ANDA065088 Henry Schein Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] N 20181231 0404-7195_aeaeeb70-1c3d-42f1-ab90-42ca296c627e 0404-7195 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 20150513 ANDA ANDA065213 Henry Schein Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE 3.5; 10000; 400; 10 mg/g; [USP'U]/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0404-7196_32d30b1f-8d8a-4318-a66b-d288ae81baa6 0404-7196 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC 20150513 ANDA ANDA064096 Henry Schein Inc. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0404-7198_53db10ac-442f-4efd-8475-56c46a508f78 0404-7198 HUMAN OTC DRUG Eyewash Water SOLUTION OPHTHALMIC 20150323 NDA NDA022305 Henry Schein, Inc. WATER 929 g/946mL E 20171231 0404-7199_5ae8fcae-060b-4911-8714-376ce56693f3 0404-7199 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20150513 ANDA ANDA040277 Henry Schein Inc. PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] N 20181231 0404-7804_c30ac908-4fa3-4f74-9e7a-b3dd789bc6bf 0404-7804 HUMAN PRESCRIPTION DRUG Benzo-Jel Cherry Benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER Henry Schein Inc BENZOCAINE 230 mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 0404-8016_4b579b08-3519-42f2-92fc-110fda9ff281 0404-8016 HUMAN PRESCRIPTION DRUG Acclean Sodium Flouride GEL, DENTIFRICE ORAL 19970101 UNAPPROVED DRUG OTHER Henry Schein Inc. SODIUM FLUORIDE 5 mg/g E 20171231 0404-9034_49c7e202-2f5e-4747-e054-00144ff88e88 0404-9034 HUMAN PRESCRIPTION DRUG Acclean Dual Fluoride Rinse Part B 1.24% Mint Fluoride LIQUID DENTAL 20170303 UNAPPROVED DRUG OTHER Henry Schein SODIUM FLUORIDE .02522 g/mL N 20181231 0404-9035_4bfc5f9d-bb04-47fe-e054-00144ff88e88 0404-9035 HUMAN PRESCRIPTION DRUG Acclean Dual Fluoride Rinse 1.24% APF Bubblegum Fluoride LIQUID DENTAL 20170303 UNAPPROVED DRUG OTHER Henry Schein SODIUM FLUORIDE .02522 g/mL N 20181231 0404-9405_4967da0b-eb46-279b-e054-00144ff8d46c 0404-9405 HUMAN PRESCRIPTION DRUG Acclean 60 Second Fluoride Treatment Fluoride GEL DENTAL 20170303 UNAPPROVED DRUG OTHER Henry Schein Inc. SODIUM FLUORIDE .0272 g/mL N 20181231 0404-9442_cd456b40-4086-4be4-9253-f11a1f2d8a24 0404-9442 HUMAN PRESCRIPTION DRUG Benzo-Jel Bubble Gum Benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER Henry Schein Inc BENZOCAINE 230 mg/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 0406-0123_82533875-c2b9-4f0f-9b91-dc1e25755e22 0406-0123 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20140901 ANDA ANDA040409 SpecGx LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0406-0124_82533875-c2b9-4f0f-9b91-dc1e25755e22 0406-0124 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20140901 ANDA ANDA040405 SpecGx LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0406-0125_82533875-c2b9-4f0f-9b91-dc1e25755e22 0406-0125 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20140901 ANDA ANDA040400 SpecGx LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0406-0127_54f07cde-514e-4935-bdf3-4fcdea02e0dc 0406-0127 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Extended-Release Methylphenidate Hydrochloride TABLET ORAL 20121228 ANDA ANDA202608 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0406-0136_54f07cde-514e-4935-bdf3-4fcdea02e0dc 0406-0136 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Extended-Release Methylphenidate Hydrochloride TABLET ORAL 20130313 ANDA ANDA202608 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0406-0154_54f07cde-514e-4935-bdf3-4fcdea02e0dc 0406-0154 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Extended-Release Methylphenidate Hydrochloride TABLET ORAL 20130325 ANDA ANDA202608 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0406-0358_82533875-c2b9-4f0f-9b91-dc1e25755e22 0406-0358 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20180930 ANDA ANDA040201 SpecGx LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0406-0365_82533875-c2b9-4f0f-9b91-dc1e25755e22 0406-0365 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 20180730 ANDA ANDA040409 SpecGx LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0406-0376_84f9a8cd-c6b9-4563-95c4-be9d88a18c8b 0406-0376 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20131125 ANDA ANDA206718 Mallinckrodt, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0406-0377_84f9a8cd-c6b9-4563-95c4-be9d88a18c8b 0406-0377 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20131125 ANDA ANDA206718 Mallinckrodt, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0406-0378_84f9a8cd-c6b9-4563-95c4-be9d88a18c8b 0406-0378 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20131125 ANDA ANDA206718 Mallinckrodt, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0406-0483_40fe6b56-de26-4f52-ab17-45d4d48e461a 0406-0483 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 SpecGx LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 0406-0484_40fe6b56-de26-4f52-ab17-45d4d48e461a 0406-0484 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 SpecGx LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 0406-0485_40fe6b56-de26-4f52-ab17-45d4d48e461a 0406-0485 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 SpecGx LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 0406-0512_528e07c0-6680-46a1-8314-23945a76da71 0406-0512 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20110308 ANDA ANDA087463 SpecGx LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-0522_528e07c0-6680-46a1-8314-23945a76da71 0406-0522 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20110308 ANDA ANDA040545 SpecGx LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-0523_528e07c0-6680-46a1-8314-23945a76da71 0406-0523 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20110308 ANDA ANDA040545 SpecGx LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-0527_e37fc76d-f8f9-40dd-be8b-f461813da087 0406-0527 HUMAN PRESCRIPTION DRUG METHADOSE methadone hydrochloride CONCENTRATE ORAL 20100310 NDA NDA017116 SpecGx LLC METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-0540_01e5f1c4-56b1-421e-9b22-2e05ba6b7f4b 0406-0540 HUMAN PRESCRIPTION DRUG METHADOSE DISPERSIBLE Methadone Hydrochloride TABLET ORAL 20100831 ANDA ANDA074184 SpecGx LLC METHADONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-0552_9af65f8a-ebd3-4530-9e74-e7d0ca7cc790 0406-0552 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20090730 ANDA ANDA076758 SpecGx LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-1009_90d68db7-f105-49b8-b4e7-39be3fe2314c 0406-1009 HUMAN PRESCRIPTION DRUG OXYMORPHONE HYDROCHLORIDE Oxymorphone Hydrochloride TABLET ORAL 20130723 ANDA ANDA202321 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-1010_90d68db7-f105-49b8-b4e7-39be3fe2314c 0406-1010 HUMAN PRESCRIPTION DRUG OXYMORPHONE HYDROCHLORIDE Oxymorphone Hydrochloride TABLET ORAL 20130723 ANDA ANDA202321 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-1142_ab555e98-b99f-44be-9b38-0a2c2a0ad8b1 0406-1142 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20110318 ANDA ANDA040300 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0406-1144_ab555e98-b99f-44be-9b38-0a2c2a0ad8b1 0406-1144 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20110318 ANDA ANDA040300 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0406-1146_ab555e98-b99f-44be-9b38-0a2c2a0ad8b1 0406-1146 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20110318 ANDA ANDA040300 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0406-1170_1f64bfb4-6360-4346-81a8-0adcb13b0fcf 0406-1170 HUMAN PRESCRIPTION DRUG NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET, FILM COATED ORAL 20090729 ANDA ANDA076264 SpecGx LLC NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20191231 0406-1180_35ca1c6f-c06c-4844-bea0-f9c569a80c66 0406-1180 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended-Release Quetiapine Fumarate TABLET, EXTENDED RELEASE ORAL 20170515 ANDA ANDA202939 MALLINCKRODT INC QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0406-1181_35ca1c6f-c06c-4844-bea0-f9c569a80c66 0406-1181 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended-Release Quetiapine Fumarate TABLET, EXTENDED RELEASE ORAL 20170515 ANDA ANDA202939 MALLINCKRODT INC QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 0406-1182_35ca1c6f-c06c-4844-bea0-f9c569a80c66 0406-1182 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended-Release Quetiapine Fumarate TABLET, EXTENDED RELEASE ORAL 20170515 ANDA ANDA202939 MALLINCKRODT INC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0406-1183_35ca1c6f-c06c-4844-bea0-f9c569a80c66 0406-1183 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended-Release Quetiapine Fumarate TABLET, EXTENDED RELEASE ORAL 20170515 ANDA ANDA202939 MALLINCKRODT INC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 0406-1184_35ca1c6f-c06c-4844-bea0-f9c569a80c66 0406-1184 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended-Release Quetiapine Fumarate TABLET, EXTENDED RELEASE ORAL 20170515 ANDA ANDA202939 MALLINCKRODT INC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 0406-1445_ab555e98-b99f-44be-9b38-0a2c2a0ad8b1 0406-1445 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110318 ANDA ANDA075629 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0406-1473_ab555e98-b99f-44be-9b38-0a2c2a0ad8b1 0406-1473 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110318 ANDA ANDA075629 Mallinckrodt, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0406-1510_fb536c3e-1f0b-4364-b83a-a83d190f59db 0406-1510 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride POWDER ORAL 20120430 20230531 NDA NDA006383 Mallinckrodt, Inc. METHADONE HYDROCHLORIDE 1 g/g Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-1810_21b09bf5-0a20-404a-9185-75499e7765d4 0406-1810 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Extended-Release methylphenidate hydrochloride CAPSULE ORAL 20150929 ANDA ANDA203583 SpecGx LLC METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-1820_21b09bf5-0a20-404a-9185-75499e7765d4 0406-1820 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Extended-Release methylphenidate hydrochloride CAPSULE ORAL 20150929 ANDA ANDA203583 SpecGx LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-1830_21b09bf5-0a20-404a-9185-75499e7765d4 0406-1830 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Extended-Release methylphenidate hydrochloride CAPSULE ORAL 20150929 ANDA ANDA203583 SpecGx LLC METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-1840_21b09bf5-0a20-404a-9185-75499e7765d4 0406-1840 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Extended-Release methylphenidate hydrochloride CAPSULE ORAL 20150929 ANDA ANDA203583 SpecGx LLC METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-1850_21b09bf5-0a20-404a-9185-75499e7765d4 0406-1850 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Extended-Release methylphenidate hydrochloride CAPSULE ORAL 20150929 ANDA ANDA203583 SpecGx LLC METHYLPHENIDATE HYDROCHLORIDE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-1860_21b09bf5-0a20-404a-9185-75499e7765d4 0406-1860 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Extended-Release methylphenidate hydrochloride CAPSULE ORAL 20150929 ANDA ANDA203583 SpecGx LLC METHYLPHENIDATE HYDROCHLORIDE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-1923_0070df14-2e60-47ac-887f-37333fb185f7 0406-1923 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 Mallinckrodt, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 0406-1924_0070df14-2e60-47ac-887f-37333fb185f7 0406-1924 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 Mallinckrodt, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 0406-2540_01e5f1c4-56b1-421e-9b22-2e05ba6b7f4b 0406-2540 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20100831 ANDA ANDA077142 SpecGx LLC METHADONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-3005_d50a2bae-56d6-40eb-b757-d47c12e8a2ca 0406-3005 HUMAN PRESCRIPTION DRUG Methylphenidate HCl Oral Solution Methylphenidate Hydrochloride SOLUTION ORAL 20130801 NDA AUTHORIZED GENERIC NDA021419 SpecGx LLC METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-3010_d50a2bae-56d6-40eb-b757-d47c12e8a2ca 0406-3010 HUMAN PRESCRIPTION DRUG Methylphenidate HCl Oral Solution Methylphenidate Hydrochloride SOLUTION ORAL 20130801 NDA AUTHORIZED GENERIC NDA021419 SpecGx LLC METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-3243_f900b15c-8078-4390-b1ce-e1b299b26b1b 0406-3243 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride hydromorphone hydrochloride TABLET ORAL 20170514 ANDA ANDA076855 SpecGx LLC HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-3244_f900b15c-8078-4390-b1ce-e1b299b26b1b 0406-3244 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride hydromorphone hydrochloride TABLET ORAL 20170514 ANDA ANDA076855 SpecGx LLC HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-3249_f900b15c-8078-4390-b1ce-e1b299b26b1b 0406-3249 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride hydromorphone hydrochloride TABLET ORAL 20170514 ANDA ANDA076855 SpecGx LLC HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-3308_6876e232-c26a-4f41-b09d-163776a66774 0406-3308 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Extended-Release Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140612 NDA AUTHORIZED GENERIC NDA021217 Mallinckrodt, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-3312_6876e232-c26a-4f41-b09d-163776a66774 0406-3312 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Extended-Release Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140612 NDA AUTHORIZED GENERIC NDA021217 Mallinckrodt, Inc. HYDROMORPHONE HYDROCHLORIDE 12 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-3316_6876e232-c26a-4f41-b09d-163776a66774 0406-3316 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Extended-Release Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140612 NDA AUTHORIZED GENERIC NDA021217 Mallinckrodt, Inc. HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-3332_6876e232-c26a-4f41-b09d-163776a66774 0406-3332 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Extended-Release Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140612 NDA AUTHORIZED GENERIC NDA021217 Mallinckrodt, Inc. HYDROMORPHONE HYDROCHLORIDE 32 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-5755_a16e4062-ff75-4330-a1fe-5f27c104ae39 0406-5755 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 SpecGx LLC METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-5771_a16e4062-ff75-4330-a1fe-5f27c104ae39 0406-5771 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 SpecGx LLC METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-8003_f801c3e6-6416-41dc-8977-4d4c3b950b5d 0406-8003 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate SOLUTION ORAL 20111003 ANDA ANDA202348 Mallinckrodt, Inc. MORPHINE SULFATE 20 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-8005_a5638960-0061-4409-9600-6b00fd8b4902 0406-8005 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate TABLET SUBLINGUAL 20131202 ANDA ANDA207000 SpecGx LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA],Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 0406-8020_a5638960-0061-4409-9600-6b00fd8b4902 0406-8020 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate TABLET SUBLINGUAL 20131202 ANDA ANDA207000 SpecGx LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 0406-8091_15b2adca-13dd-44b9-8e3f-d2bf0a1aed89 0406-8091 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-8092_15b2adca-13dd-44b9-8e3f-d2bf0a1aed89 0406-8092 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-8093_15b2adca-13dd-44b9-8e3f-d2bf0a1aed89 0406-8093 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-8094_15b2adca-13dd-44b9-8e3f-d2bf0a1aed89 0406-8094 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-8095_15b2adca-13dd-44b9-8e3f-d2bf0a1aed89 0406-8095 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-8096_15b2adca-13dd-44b9-8e3f-d2bf0a1aed89 0406-8096 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-8097_15b2adca-13dd-44b9-8e3f-d2bf0a1aed89 0406-8097 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Extended-Release Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140627 ANDA ANDA202946 Mallinckrodt, Inc. OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-8315_321e6df6-6304-4433-b6d8-1a413f4d3db3 0406-8315 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076412 SpecGx LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-8320_321e6df6-6304-4433-b6d8-1a413f4d3db3 0406-8320 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076438 SpecGx LLC MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-8330_321e6df6-6304-4433-b6d8-1a413f4d3db3 0406-8330 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076412 SpecGx LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-8380_321e6df6-6304-4433-b6d8-1a413f4d3db3 0406-8380 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076412 SpecGx LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-8390_321e6df6-6304-4433-b6d8-1a413f4d3db3 0406-8390 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076438 SpecGx LLC MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-8515_9af65f8a-ebd3-4530-9e74-e7d0ca7cc790 0406-8515 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20090730 ANDA ANDA076758 SpecGx LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-8530_9af65f8a-ebd3-4530-9e74-e7d0ca7cc790 0406-8530 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20090730 ANDA ANDA076758 SpecGx LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-8553_fdd3e474-2f71-4824-a215-8ef5aeaee719 0406-8553 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone and acetaminophen SOLUTION ORAL 20110310 ANDA ANDA040680 Mallinckrodt, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-8725_e37fc76d-f8f9-40dd-be8b-f461813da087 0406-8725 HUMAN PRESCRIPTION DRUG METHADOSE SUGAR-FREE methadone hydrochloride CONCENTRATE ORAL 20100310 NDA NDA017116 SpecGx LLC METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-8806_cc69bd7a-8db4-4ccb-bb12-b51ce75397cc 0406-8806 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CAPSULE ORAL 20150601 NDA NDA019906 Mallinckrodt, Inc. CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0406-8807_cc69bd7a-8db4-4ccb-bb12-b51ce75397cc 0406-8807 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CAPSULE ORAL 20150601 NDA NDA019906 Mallinckrodt, Inc. CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0406-8808_cc69bd7a-8db4-4ccb-bb12-b51ce75397cc 0406-8808 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CAPSULE ORAL 20150601 NDA NDA019906 Mallinckrodt, Inc. CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0406-8884_2222b1ac-be13-44ca-8242-d21798fe13fc 0406-8884 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20100218 ANDA ANDA040440 SpecGx LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-8885_2222b1ac-be13-44ca-8242-d21798fe13fc 0406-8885 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20100218 ANDA ANDA040440 SpecGx LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-8891_2222b1ac-be13-44ca-8242-d21798fe13fc 0406-8891 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20100218 ANDA ANDA040440 SpecGx LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-8892_2222b1ac-be13-44ca-8242-d21798fe13fc 0406-8892 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20100218 ANDA ANDA040440 SpecGx LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-8893_2222b1ac-be13-44ca-8242-d21798fe13fc 0406-8893 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20100218 ANDA ANDA040440 SpecGx LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-8894_2222b1ac-be13-44ca-8242-d21798fe13fc 0406-8894 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20100218 ANDA ANDA040440 SpecGx LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-8958_5c0b9a73-d602-4b72-8226-4bd0f31f7370 0406-8958 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET ORAL 20100205 ANDA ANDA040436 SpecGx LLC DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-8959_5c0b9a73-d602-4b72-8226-4bd0f31f7370 0406-8959 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET ORAL 20100205 ANDA ANDA040436 SpecGx LLC DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-8960_20dbb7f7-a1db-4b1c-a8d7-15b0c92cea19 0406-8960 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111007 ANDA ANDA076353 SpecGx LLC DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-8961_20dbb7f7-a1db-4b1c-a8d7-15b0c92cea19 0406-8961 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111007 ANDA ANDA076353 SpecGx LLC DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-8962_20dbb7f7-a1db-4b1c-a8d7-15b0c92cea19 0406-8962 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111007 ANDA ANDA076353 SpecGx LLC DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 0406-9000_1707ce83-fe0f-4416-b877-08cee8a5a01e 0406-9000 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Mallinckrodt, Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-9012_1707ce83-fe0f-4416-b877-08cee8a5a01e 0406-9012 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Mallinckrodt, Inc. FENTANYL 12.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-9025_1707ce83-fe0f-4416-b877-08cee8a5a01e 0406-9025 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Mallinckrodt, Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-9050_1707ce83-fe0f-4416-b877-08cee8a5a01e 0406-9050 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Mallinckrodt, Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-9075_1707ce83-fe0f-4416-b877-08cee8a5a01e 0406-9075 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Mallinckrodt, Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0406-9202_35959e1c-80ea-40d1-9558-83bb9bf4ac72 0406-9202 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE LOZENGE TRANSMUCOSAL 20100115 ANDA ANDA078907 SpecGx LLC FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-9204_35959e1c-80ea-40d1-9558-83bb9bf4ac72 0406-9204 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE LOZENGE TRANSMUCOSAL 20100115 ANDA ANDA078907 SpecGx LLC FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-9206_35959e1c-80ea-40d1-9558-83bb9bf4ac72 0406-9206 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE LOZENGE TRANSMUCOSAL 20100115 ANDA ANDA078907 SpecGx LLC FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-9208_35959e1c-80ea-40d1-9558-83bb9bf4ac72 0406-9208 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE LOZENGE TRANSMUCOSAL 20100115 ANDA ANDA078907 SpecGx LLC FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-9212_35959e1c-80ea-40d1-9558-83bb9bf4ac72 0406-9212 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE LOZENGE TRANSMUCOSAL 20100115 ANDA ANDA078907 SpecGx LLC FENTANYL CITRATE 1200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-9216_35959e1c-80ea-40d1-9558-83bb9bf4ac72 0406-9216 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE LOZENGE TRANSMUCOSAL 20100115 ANDA ANDA078907 SpecGx LLC FENTANYL CITRATE 1600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0406-9906_554b5dba-dea9-41ef-9302-fdfd35496f3c 0406-9906 HUMAN PRESCRIPTION DRUG ANAFRANIL clomipramine hydrochloride CAPSULE ORAL 20110318 NDA NDA019906 Mallinckrodt, Inc. CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0406-9907_554b5dba-dea9-41ef-9302-fdfd35496f3c 0406-9907 HUMAN PRESCRIPTION DRUG ANAFRANIL clomipramine hydrochloride CAPSULE ORAL 20110318 NDA NDA019906 Mallinckrodt, Inc. CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0406-9908_554b5dba-dea9-41ef-9302-fdfd35496f3c 0406-9908 HUMAN PRESCRIPTION DRUG ANAFRANIL clomipramine hydrochloride CAPSULE ORAL 20110318 NDA NDA019906 Mallinckrodt, Inc. CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0406-9910_91025b46-a47a-4657-9204-cead9e26924e 0406-9910 HUMAN PRESCRIPTION DRUG PAMELOR nortriptyline hydrochloride CAPSULE ORAL 20100803 NDA NDA018013 Mallinckrodt, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0406-9911_91025b46-a47a-4657-9204-cead9e26924e 0406-9911 HUMAN PRESCRIPTION DRUG PAMELOR nortriptyline hydrochloride CAPSULE ORAL 20100803 NDA NDA018013 Mallinckrodt, Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0406-9912_91025b46-a47a-4657-9204-cead9e26924e 0406-9912 HUMAN PRESCRIPTION DRUG PAMELOR nortriptyline hydrochloride CAPSULE ORAL 20100803 NDA NDA018013 Mallinckrodt, Inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0406-9913_91025b46-a47a-4657-9204-cead9e26924e 0406-9913 HUMAN PRESCRIPTION DRUG PAMELOR nortriptyline hydrochloride CAPSULE ORAL 20100803 NDA NDA018013 Mallinckrodt, Inc. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0406-9914_d9de4a42-2642-48fc-93dc-a63109255ab6 0406-9914 HUMAN PRESCRIPTION DRUG RESTORIL temazepam CAPSULE ORAL 20110707 NDA NDA018163 SpecGx LLC TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0406-9915_d9de4a42-2642-48fc-93dc-a63109255ab6 0406-9915 HUMAN PRESCRIPTION DRUG RESTORIL temazepam CAPSULE ORAL 20110707 NDA NDA018163 SpecGx LLC TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0406-9916_d9de4a42-2642-48fc-93dc-a63109255ab6 0406-9916 HUMAN PRESCRIPTION DRUG RESTORIL temazepam CAPSULE ORAL 20110707 NDA NDA018163 SpecGx LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0406-9917_d9de4a42-2642-48fc-93dc-a63109255ab6 0406-9917 HUMAN PRESCRIPTION DRUG RESTORIL temazepam CAPSULE ORAL 20110707 NDA NDA018163 SpecGx LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0406-9920_261f0236-8f31-47dd-9c3d-62a39a7488e5 0406-9920 HUMAN PRESCRIPTION DRUG TOFRANIL imipramine hydrochloride TABLET, SUGAR COATED ORAL 20110124 ANDA ANDA087846 SpecGx LLC IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20191231 0406-9921_261f0236-8f31-47dd-9c3d-62a39a7488e5 0406-9921 HUMAN PRESCRIPTION DRUG TOFRANIL imipramine hydrochloride TABLET, SUGAR COATED ORAL 20110124 ANDA ANDA087846 SpecGx LLC IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 0406-9922_261f0236-8f31-47dd-9c3d-62a39a7488e5 0406-9922 HUMAN PRESCRIPTION DRUG TOFRANIL imipramine hydrochloride TABLET, SUGAR COATED ORAL 20110124 ANDA ANDA087846 SpecGx LLC IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 0406-9959_cb778eca-7338-4ff0-9929-ffa5f68e3900 0406-9959 HUMAN PRESCRIPTION DRUG TEMAZEPAM temazepam CAPSULE ORAL 20100223 NDA NDA018163 SpecGx LLC TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0406-9960_cb778eca-7338-4ff0-9929-ffa5f68e3900 0406-9960 HUMAN PRESCRIPTION DRUG TEMAZEPAM temazepam CAPSULE ORAL 20100223 NDA NDA018163 SpecGx LLC TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0407-0690_39df0de4-7294-4155-8c97-5ab64b384613 0407-0690 HUMAN PRESCRIPTION DRUG OMNISCAN gadodiamide INJECTION INTRAVENOUS 20020419 NDA NDA020123 GE Healthcare Inc. GADODIAMIDE 287 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0407-0690_875569ec-4bbb-4b65-992e-3e679445b185 0407-0690 HUMAN PRESCRIPTION DRUG OMNISCAN gadodiamide INJECTION INTRAVENOUS 20100601 NDA NDA020123 GE Healthcare Inc. GADODIAMIDE 287 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0407-0690_c6462558-0a56-4503-9a87-ccf4c808f353 0407-0690 HUMAN PRESCRIPTION DRUG OMNISCAN gadodiamide INJECTION INTRAVENOUS 20071002 NDA NDA022066 GE Healthcare Inc. GADODIAMIDE 287 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0407-0691_39df0de4-7294-4155-8c97-5ab64b384613 0407-0691 HUMAN PRESCRIPTION DRUG OMNISCAN gadodiamide INJECTION INTRAVENOUS 20060921 NDA NDA020123 GE Healthcare Inc. GADODIAMIDE 287 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0407-0691_875569ec-4bbb-4b65-992e-3e679445b185 0407-0691 HUMAN PRESCRIPTION DRUG OMNISCAN gadodiamide INJECTION INTRAVENOUS 20050729 NDA NDA020123 GE Healthcare Inc. GADODIAMIDE 287 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0407-1401_9fc26d9b-dfdd-4f05-a9a7-b7cd5e872f99 0407-1401 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRAVENOUS 20040525 NDA NDA018956 GE Healthcare Inc. IOHEXOL 140 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1411_9fc26d9b-dfdd-4f05-a9a7-b7cd5e872f99 0407-1411 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRAVENOUS 20040715 NDA NDA018956 GE Healthcare Inc. IOHEXOL 180 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1412_8189551d-c91e-4031-88d9-3dd0f2ab8c97 0407-1412 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL 20050811 NDA NDA018956 GE Healthcare Inc. IOHEXOL 518 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1412_9fc26d9b-dfdd-4f05-a9a7-b7cd5e872f99 0407-1412 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRAVENOUS 19851226 NDA NDA018956 GE Healthcare Inc. IOHEXOL 240 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1413_0bf3b4b7-a235-448f-a7ab-f2ec305501d7 0407-1413 HUMAN PRESCRIPTION DRUG Omnipaque Iohexol INJECTION, SOLUTION INTRAVENOUS 20161221 NDA NDA020608 GE Healthcare IOHEXOL 300 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1413_27a68f8e-7563-4b6c-b6a4-dd265137de06 0407-1413 HUMAN PRESCRIPTION DRUG Omnipaque Iohexol INJECTION, SOLUTION INTRAVENOUS 20161221 NDA NDA020608 GE Healthcare IOHEXOL 300 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1413_8189551d-c91e-4031-88d9-3dd0f2ab8c97 0407-1413 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL 20060921 NDA NDA018956 GE Healthcare Inc. IOHEXOL 647 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1413_8a4511e4-21bc-4d1a-8876-14b52b282a3a 0407-1413 HUMAN PRESCRIPTION DRUG Omnipaque Iohexol INJECTION INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL 20050803 NDA NDA020608 GE Healthcare Inc. IOHEXOL 300 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1413_9fc26d9b-dfdd-4f05-a9a7-b7cd5e872f99 0407-1413 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRAVENOUS 19851226 NDA NDA018956 GE Healthcare Inc. IOHEXOL 300 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1413_a091b941-18ca-47cf-a8b1-96d6d82c2c9c 0407-1413 HUMAN PRESCRIPTION DRUG Omnipaque Iohexol INJECTION, SOLUTION INTRAVENOUS 20040903 NDA NDA020608 GE Healthcare Inc. IOHEXOL 300 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1414_0bf3b4b7-a235-448f-a7ab-f2ec305501d7 0407-1414 HUMAN PRESCRIPTION DRUG Omnipaque Iohexol INJECTION, SOLUTION INTRAVENOUS 20161221 NDA NDA020608 GE Healthcare IOHEXOL 350 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1414_27a68f8e-7563-4b6c-b6a4-dd265137de06 0407-1414 HUMAN PRESCRIPTION DRUG Omnipaque Iohexol INJECTION, SOLUTION INTRAVENOUS 20161221 NDA NDA020608 GE Healthcare IOHEXOL 350 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1414_8189551d-c91e-4031-88d9-3dd0f2ab8c97 0407-1414 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRAVASCULAR; INTRAVENOUS; ORAL 20060721 NDA NDA018956 GE Healthcare Inc. IOHEXOL 755 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1414_8a4511e4-21bc-4d1a-8876-14b52b282a3a 0407-1414 HUMAN PRESCRIPTION DRUG Omnipaque Iohexol INJECTION INTRAVASCULAR; INTRAVENOUS; ORAL 20050803 NDA NDA020608 GE Healthcare Inc. IOHEXOL 350 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1414_9fc26d9b-dfdd-4f05-a9a7-b7cd5e872f99 0407-1414 HUMAN PRESCRIPTION DRUG OMNIPAQUE Iohexol INJECTION INTRAVENOUS 19851226 NDA NDA018956 GE Healthcare Inc. IOHEXOL 350 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-1414_a091b941-18ca-47cf-a8b1-96d6d82c2c9c 0407-1414 HUMAN PRESCRIPTION DRUG Omnipaque Iohexol INJECTION, SOLUTION INTRAVENOUS 20040903 NDA NDA020608 GE Healthcare Inc. IOHEXOL 350 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-2222_53130b10-9dc3-44a0-863d-1b773b126d2a 0407-2222 HUMAN PRESCRIPTION DRUG Visipaque Iodixanol INJECTION, SOLUTION INTRAVASCULAR 20090301 NDA NDA020808 GE Healthcare Inc. IODIXANOL 270 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-2222_89cd1e3f-8d43-4a49-ac86-0cee1235cd1f 0407-2222 HUMAN PRESCRIPTION DRUG Visipaque Iodixanol INJECTION, SOLUTION INTRAVASCULAR 20021213 NDA NDA020351 GE Healthcare Inc. IODIXANOL 270 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-2223_53130b10-9dc3-44a0-863d-1b773b126d2a 0407-2223 HUMAN PRESCRIPTION DRUG Visipaque Iodixanol INJECTION, SOLUTION INTRAVASCULAR 20060501 NDA NDA020808 GE Healthcare Inc. IODIXANOL 320 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-2223_89cd1e3f-8d43-4a49-ac86-0cee1235cd1f 0407-2223 HUMAN PRESCRIPTION DRUG Visipaque Iodixanol INJECTION, SOLUTION INTRAVASCULAR 20030909 NDA NDA020351 GE Healthcare Inc. IODIXANOL 320 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-2223_a160e528-11c2-4f0c-9db8-6f3f6535f35e 0407-2223 HUMAN PRESCRIPTION DRUG Visipaque Iodixanol INJECTION, SOLUTION INTRAVASCULAR 20100601 NDA NDA020351 GE Healthcare Inc. IODIXANOL 320 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 0407-2707_57599101-7540-42e9-ba28-b71ddd19bfa6 0407-2707 HUMAN PRESCRIPTION DRUG Optison Perflutren Protein-Type A Microspheres Human Albumin Microspheres and Perflutren INJECTION, SOLUTION INTRAVENOUS 20020102 NDA NDA020899 GE Healthcare Inc. HUMAN ALBUMIN MICROSPHERES; PERFLUTREN 10; .22 mg/mL; mg/mL Contrast Agent for Ultrasound Imaging [EPC],Ultrasound Contrast Activity [MoA],Contrast Agent for Ultrasound Imaging [EPC],Ultrasound Contrast Activity [MoA] N 20181231 0409-0106_884cd3c5-3246-4e9a-8d27-64f41e50cb3b 0409-0106 HUMAN PRESCRIPTION DRUG Daptomycin DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170104 ANDA ANDA202857 Hospira, Inc. DAPTOMYCIN 500 mg/10mL Lipopeptide Antibacterial [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 0409-0144_0428048a-0d8b-4d08-8af4-a9ae4b7ff52d 0409-0144 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090626 ANDA ANDA065500 Hospira, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0409-0144_58b209bc-63ac-4de9-aa04-7f36327ba9c4 0409-0144 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111230 ANDA ANDA065511 Hospira, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0409-0181_695ba2a9-02bc-4b66-867d-aa2dd21ee588 0409-0181 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE INJECTION, SOLUTION INTRAVENOUS 20130709 NDA NDA200795 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 0409-0181_b77a607d-f5e2-42f0-bfd5-64362e293fbf 0409-0181 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE INJECTION, SOLUTION INTRAVENOUS 20110826 NDA NDA200795 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 0409-0182_695ba2a9-02bc-4b66-867d-aa2dd21ee588 0409-0182 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE INJECTION, SOLUTION INTRAVENOUS 20130729 NDA NDA200795 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 0409-0182_b77a607d-f5e2-42f0-bfd5-64362e293fbf 0409-0182 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE INJECTION, SOLUTION INTRAVENOUS 20110822 NDA NDA200795 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 0409-0183_695ba2a9-02bc-4b66-867d-aa2dd21ee588 0409-0183 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE INJECTION, SOLUTION INTRAVENOUS 20130709 NDA NDA200795 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 0409-0183_b77a607d-f5e2-42f0-bfd5-64362e293fbf 0409-0183 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE INJECTION, SOLUTION INTRAVENOUS 20110824 NDA NDA200795 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 0409-0185_26123b18-8db8-472e-b014-d3ee9af82b1d 0409-0185 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110726 ANDA ANDA078339 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0409-0186_26123b18-8db8-472e-b014-d3ee9af82b1d 0409-0186 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110726 ANDA ANDA078339 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0409-0187_c7827741-4e9e-4065-a0e3-3e9e033e9f95 0409-0187 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20101115 ANDA ANDA079183 Hospira, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0409-0201_4302270d-579f-4f7f-9ec1-892caeb236ee 0409-0201 HUMAN PRESCRIPTION DRUG Docetaxel DOCETAXEL ANHYDROUS INJECTION, SOLUTION INTRAVENOUS 20110317 NDA NDA022234 Hospira, Inc. DOCETAXEL ANHYDROUS 10 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0409-0212_2f802f2e-7bd8-41f3-a9c3-c64379deaeb4 0409-0212 HUMAN PRESCRIPTION DRUG MILRINONE LACTATE MILRINONE LACTATE INJECTION, SOLUTION INTRAVENOUS 20140903 ANDA ANDA203280 Hospira, Inc. MILRINONE LACTATE 1 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0409-0217_e7b17358-ff09-4a0c-b94a-e08462dee95c 0409-0217 HUMAN PRESCRIPTION DRUG MAXIPIME Cefepime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130218 NDA NDA050679 Hospira, Inc. CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-0218_e7b17358-ff09-4a0c-b94a-e08462dee95c 0409-0218 HUMAN PRESCRIPTION DRUG MAXIPIME Cefepime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130218 NDA NDA050679 Hospira, Inc. CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-0219_e7b17358-ff09-4a0c-b94a-e08462dee95c 0409-0219 HUMAN PRESCRIPTION DRUG MAXIPIME Cefepime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130218 NDA NDA050679 Hospira, Inc. CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-0220_e7b17358-ff09-4a0c-b94a-e08462dee95c 0409-0220 HUMAN PRESCRIPTION DRUG MAXIPIME Cefepime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130218 NDA NDA050679 Hospira, Inc. CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-0221_e7b17358-ff09-4a0c-b94a-e08462dee95c 0409-0221 HUMAN PRESCRIPTION DRUG MAXIPIME Cefepime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19960118 NDA NDA050679 Hospira, Inc. CEFEPIME HYDROCHLORIDE 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-0302_b5b2e022-38f2-489a-b050-9278f7e56b7f 0409-0302 HUMAN PRESCRIPTION DRUG Topotecan TOPOTECAN INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20110202 NDA NDA200582 Hospira, Inc. TOPOTECAN HYDROCHLORIDE 1 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20191231 0409-0366_183489ad-70e9-43eb-b9a7-3098ab662d0f 0409-0366 HUMAN PRESCRIPTION DRUG Docetaxel DOCETAXEL INJECTION, SOLUTION INTRAVENOUS 20160824 NDA NDA022234 Hospira, Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20191231 0409-0367_183489ad-70e9-43eb-b9a7-3098ab662d0f 0409-0367 HUMAN PRESCRIPTION DRUG Docetaxel DOCETAXEL INJECTION, SOLUTION INTRAVENOUS 20160824 NDA NDA022234 Hospira, Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20191231 0409-0368_183489ad-70e9-43eb-b9a7-3098ab662d0f 0409-0368 HUMAN PRESCRIPTION DRUG Docetaxel DOCETAXEL INJECTION, SOLUTION INTRAVENOUS 20180109 NDA NDA022234 Hospira, Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20191231 0409-0468_a78532c7-f1b4-446b-9b2a-103e51590629 0409-0468 HUMAN PRESCRIPTION DRUG Novamine LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20111122 NDA NDA017957 Hospira, Inc. LYSINE ACETATE; LEUCINE; PHENYLALANINE; VALINE; ISOLEUCINE; METHIONINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; HISTIDINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE 1.18; 1.04; 1.04; 960; 749; 749; 749; 250; 2.17; 1.47; 1.04; 894; 894; 749; 592; 434; 39 g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0409-0528_b47bed93-ae28-48a2-93ee-7dcd8f9e027d 0409-0528 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN INJECTION, SOLUTION INTRAVENOUS 20170612 ANDA ANDA078579 Hospira, Inc. LEVOFLOXACIN 5 mg/mL N 20181231 0409-0801_df105027-8876-467a-b2e9-43c1be90764f 0409-0801 HUMAN PRESCRIPTION DRUG Nipent PENTOSTATIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20070815 NDA NDA020122 Hospira, Inc. PENTOSTATIN 2 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 0409-0805_c71b4076-b7ce-474f-8705-b2edd7e4f590 0409-0805 HUMAN PRESCRIPTION DRUG Cefazolin CEFAZOLIN INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090327 ANDA ANDA065226 Hospira, Inc. CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 0409-0806_3e5886e9-cd52-49b2-b14e-ec6fa6ef5e27 0409-0806 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090327 ANDA ANDA065247 Hospira, Inc. CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-1007_0acd0290-8b34-4545-a538-8b47797dabdd 0409-1007 HUMAN PRESCRIPTION DRUG Paricalcitol PARICALCITOL INJECTION, SOLUTION INTRAVENOUS 20141201 NDA NDA201657 Hospira, Inc. PARICALCITOL 2 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0409-1008_0acd0290-8b34-4545-a538-8b47797dabdd 0409-1008 HUMAN PRESCRIPTION DRUG Paricalcitol PARICALCITOL INJECTION, SOLUTION INTRAVENOUS 20141101 NDA NDA201657 Hospira, Inc. PARICALCITOL 5 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 0409-1029_4cf79958-bba6-4ab0-b970-92b80ce04439 0409-1029 HUMAN PRESCRIPTION DRUG Voluven HYDROXYETHYL STARCH 130/0.4 INJECTION, SOLUTION INTRAVENOUS 20100625 NDA BN070012 Hospira Inc. HYDROXYETHYL STARCH 130/0.4 6 g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient] N 20181231 0409-1036_a309b6ad-094e-49d5-ab55-7de9dc8814ae 0409-1036 HUMAN PRESCRIPTION DRUG Carbocaine Mepivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20060323 NDA NDA012250 Hospira, Inc. MEPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1038_a309b6ad-094e-49d5-ab55-7de9dc8814ae 0409-1038 HUMAN PRESCRIPTION DRUG Carbocaine Mepivacaine Hydrochloride INJECTION, SOLUTION INFILTRATION 20071010 NDA NDA012250 Hospira, Inc. MEPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1041_a309b6ad-094e-49d5-ab55-7de9dc8814ae 0409-1041 HUMAN PRESCRIPTION DRUG Carbocaine Mepivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20060428 NDA NDA012250 Hospira, Inc. MEPIVACAINE HYDROCHLORIDE 15 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1067_a309b6ad-094e-49d5-ab55-7de9dc8814ae 0409-1067 HUMAN PRESCRIPTION DRUG Carbocaine Mepivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20070131 NDA NDA012250 Hospira, Inc. MEPIVACAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1068_b30e807c-a824-4412-b641-ff1991075bfc 0409-1068 HUMAN PRESCRIPTION DRUG Dyloject DICLOFENAC SODIUM INJECTION, SOLUTION INTRAVENOUS 20150720 NDA NDA022396 Hospira, Inc. DICLOFENAC SODIUM 37.5 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0409-1105_2099bd9f-feff-4fb4-95f7-c05f591c145f 0409-1105 HUMAN PRESCRIPTION DRUG Atracurium Besylate ATRACURIUM BESYLATE INJECTION, SOLUTION INTRAVENOUS 20121018 ANDA ANDA090761 Hospira, Inc. ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0409-1109_2099bd9f-feff-4fb4-95f7-c05f591c145f 0409-1109 HUMAN PRESCRIPTION DRUG Atracurium Besylate ATRACURIUM BESYLATE INJECTION, SOLUTION INTRAVENOUS 20121018 ANDA ANDA090782 Hospira, Inc. ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0409-1113_da3ebb1a-f478-4cd5-9f63-799d55e5bde4 0409-1113 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170131 ANDA ANDA204118 Hospira, Inc. INDOMETHACIN SODIUM 1 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0409-1120_8354d0fe-94ba-4720-835a-70ec06ca25e0 0409-1120 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111014 ANDA ANDA077840 Hospira, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0409-1134_edf46633-836f-49d7-9163-bd85537832a9 0409-1134 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19960314 UNAPPROVED DRUG OTHER Hospira, Inc. MORPHINE SULFATE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1135_edf46633-836f-49d7-9163-bd85537832a9 0409-1135 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19960314 UNAPPROVED DRUG OTHER Hospira, Inc. MORPHINE SULFATE 25 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1140_3095452d-febc-4fb6-9460-30e3bfe329c5 0409-1140 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION, SOLUTION INTRAVENOUS 20170306 ANDA ANDA204120 Hospira, Inc. ARGATROBAN 100 mg/mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20191231 0409-1141_99f294df-6aff-40e7-98d5-994b0bd4899e 0409-1141 HUMAN PRESCRIPTION DRUG SODIUM CHLORIDE SODIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170619 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM CHLORIDE 234 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-1141_e5ea67f2-c000-448c-a1b7-b9546491d311 0409-1141 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050430 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM CHLORIDE 234 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-1144_f3995079-7b9f-4ca7-9e3a-1d93b645e558 0409-1144 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050331 ANDA ANDA070737 Hospira, Inc. VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0409-1159_434761e6-ce15-44c4-a40d-15d3afd5cb03 0409-1159 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050506 ANDA ANDA070583 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1159_60a521fb-5c7d-4d75-93ff-4335f2a01ae8 0409-1159 HUMAN PRESCRIPTION DRUG BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20150811 ANDA ANDA070583 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1160_434761e6-ce15-44c4-a40d-15d3afd5cb03 0409-1160 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20050430 ANDA ANDA070590 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1161_434761e6-ce15-44c4-a40d-15d3afd5cb03 0409-1161 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL; PERINEURAL 20041130 20180601 ANDA ANDA070609 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1162_434761e6-ce15-44c4-a40d-15d3afd5cb03 0409-1162 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL; PERINEURAL 20051122 ANDA ANDA070584 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1162_60a521fb-5c7d-4d75-93ff-4335f2a01ae8 0409-1162 HUMAN PRESCRIPTION DRUG BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTION, SOLUTION EPIDURAL; INTRACAUDAL; PERINEURAL 20170207 ANDA ANDA070584 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1163_434761e6-ce15-44c4-a40d-15d3afd5cb03 0409-1163 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION PERINEURAL 20050331 ANDA ANDA070597 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1165_434761e6-ce15-44c4-a40d-15d3afd5cb03 0409-1165 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; RETROBULBAR 20050608 ANDA ANDA070585 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1171_2b11f984-77c0-4377-a8e8-7d3d2986d139 0409-1171 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20060505 ANDA ANDA074941 Hospira, Inc. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 0409-1176_4c752f8d-beb7-4e3e-bb0d-b9dd493eaff9 0409-1176 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050825 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 25 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1178_4c752f8d-beb7-4e3e-bb0d-b9dd493eaff9 0409-1178 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050913 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1179_4c752f8d-beb7-4e3e-bb0d-b9dd493eaff9 0409-1179 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20051012 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 75 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1180_4c752f8d-beb7-4e3e-bb0d-b9dd493eaff9 0409-1180 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050915 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 100 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1181_4c752f8d-beb7-4e3e-bb0d-b9dd493eaff9 0409-1181 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20060224 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1187_31537bf9-be05-44c1-88b0-da2009b849ad 0409-1187 HUMAN PRESCRIPTION DRUG Droperidol DROPERIDOL INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19880229 ANDA ANDA071981 Hospira, Inc. DROPERIDOL 2.5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20191231 0409-1201_4c752f8d-beb7-4e3e-bb0d-b9dd493eaff9 0409-1201 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20060315 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 100 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1203_4c752f8d-beb7-4e3e-bb0d-b9dd493eaff9 0409-1203 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20051229 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 25 mg/.5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1207_d568aba3-afb0-4b39-bc23-4818c881b421 0409-1207 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140701 ANDA ANDA062420 Hospira, Inc. GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0409-1207_f3099a02-ceed-43b7-bc87-fb639343d83e 0409-1207 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050829 ANDA ANDA062420 Hospira, Inc. GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0409-1209_301b290f-31ad-495b-85d4-16b59d8b0a65 0409-1209 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE INJECTION, SOLUTION EPIDURAL 19850913 ANDA ANDA088571 Hospira, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 15; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-1215_839c05f7-0050-4954-a087-a21923b63c7a 0409-1215 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140501 ANDA ANDA070256 Hospira, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20191231 0409-1215_f2183ead-bb44-4961-a714-17cb538ec3cc 0409-1215 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050712 ANDA ANDA070256 Hospira, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20191231 0409-1219_839c05f7-0050-4954-a087-a21923b63c7a 0409-1219 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140409 ANDA ANDA070257 Hospira, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20191231 0409-1219_f2183ead-bb44-4961-a714-17cb538ec3cc 0409-1219 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050902 ANDA ANDA070257 Hospira, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20191231 0409-1253_4c752f8d-beb7-4e3e-bb0d-b9dd493eaff9 0409-1253 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20060104 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1254_4c752f8d-beb7-4e3e-bb0d-b9dd493eaff9 0409-1254 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20060322 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 75 mg/1.5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1255_4c752f8d-beb7-4e3e-bb0d-b9dd493eaff9 0409-1255 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20051212 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 100 mg/2mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1256_4c752f8d-beb7-4e3e-bb0d-b9dd493eaff9 0409-1256 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20060208 NDA NDA021171 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 100 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1273_05500f91-4c1d-4c6a-87a9-684b2cfef4e8 0409-1273 HUMAN PRESCRIPTION DRUG Diazepam DIAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050823 ANDA ANDA072079 Hospira, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 0409-1276_c237f8c4-0f09-4905-aadb-86c3a9b000b9 0409-1276 HUMAN PRESCRIPTION DRUG Fentanyl Citrate FENTANYL CITRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050720 ANDA ANDA072786 Hospira, Inc. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0409-1283_e06a7c74-0af2-4fc7-8a55-0cccd949bdaa 0409-1283 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1304_e06a7c74-0af2-4fc7-8a55-0cccd949bdaa 0409-1304 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1312_e06a7c74-0af2-4fc7-8a55-0cccd949bdaa 0409-1312 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1316_15074707-3bd6-4bbd-9c13-0c34dc4fab9d 0409-1316 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050228 ANDA ANDA089522 Hospira, Inc. HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0409-1323_14fbd3bf-15ff-4c70-9cb3-3f7239bfc1a1 0409-1323 HUMAN PRESCRIPTION DRUG LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20051209 ANDA ANDA040302 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-1402_15074707-3bd6-4bbd-9c13-0c34dc4fab9d 0409-1402 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050131 ANDA ANDA088100 Hospira, Inc. HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0409-1412_3b8bcc6b-8a49-419a-b420-ed4d5200dd78 0409-1412 HUMAN PRESCRIPTION DRUG Bumetanide BUMETANIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060706 ANDA ANDA074332 Hospira, Inc. BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0409-1442_ccb8f8a1-d89f-46d9-a5d1-0e8bafca27fb 0409-1442 HUMAN PRESCRIPTION DRUG Isuprel ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20130321 NDA NDA010515 Hospira, Inc. ISOPROTERENOL HYDROCHLORIDE .2 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20181231 0409-1443_60484401-eb13-4cc3-91e8-8a0b30e02122 0409-1443 HUMAN PRESCRIPTION DRUG Levophed Norepinephrine bitartrate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130701 NDA NDA007513 Hospira, Inc. NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-1443_981cbe7e-9b31-4933-bd33-8842112fa5fd 0409-1443 HUMAN PRESCRIPTION DRUG Levophed Norepinephrine bitartrate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050430 NDA NDA007513 Hospira, Inc. NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-1463_b51c097c-567a-44ad-bd30-ced09525a7da 0409-1463 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050331 ANDA ANDA070914 Hospira, Inc. NALBUPHINE HYDROCHLORIDE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] N 20181231 0409-1463_fbd38839-b2cd-46d6-815e-1e04d8147fe7 0409-1463 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20080627 ANDA ANDA070914 Hospira, Inc. NALBUPHINE HYDROCHLORIDE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] N 20181231 0409-1464_b51c097c-567a-44ad-bd30-ced09525a7da 0409-1464 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050719 ANDA ANDA070915 Hospira, Inc. NALBUPHINE HYDROCHLORIDE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] N 20181231 0409-1465_b51c097c-567a-44ad-bd30-ced09525a7da 0409-1465 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20041231 ANDA ANDA070916 Hospira, Inc. NALBUPHINE HYDROCHLORIDE 20 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] N 20181231 0409-1467_b51c097c-567a-44ad-bd30-ced09525a7da 0409-1467 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride NALBUPHINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050516 ANDA ANDA070918 Hospira, Inc. NALBUPHINE HYDROCHLORIDE 20 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] N 20181231 0409-1539_b7370a5d-135f-4bdc-894e-81472dc89198 0409-1539 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051228 ANDA ANDA074243 Hospira, Inc. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-1555_aea5152b-6373-4a47-84f5-d9d499eaf7d3 0409-1555 HUMAN PRESCRIPTION DRUG Hextend HETASTARCH INJECTION, SOLUTION INTRAVENOUS 19990331 NDA BN200952 Hospira, Inc. HETASTARCH 6 g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient] N 20181231 0409-1559_97221408-bacb-4cbc-bb09-7b9fec7fa3f9 0409-1559 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050823 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 0409-1560_97221408-bacb-4cbc-bb09-7b9fec7fa3f9 0409-1560 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL; PERINEURAL 20050816 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 0409-1582_97221408-bacb-4cbc-bb09-7b9fec7fa3f9 0409-1582 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; RETROBULBAR 20050727 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 0409-1587_97221408-bacb-4cbc-bb09-7b9fec7fa3f9 0409-1587 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20060117 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 0409-1590_5cf21128-2bd9-4e95-9bd1-27631b5451a1 0409-1590 HUMAN PRESCRIPTION DRUG Sterile Water WATER LIQUID INTRAVENOUS 19710623 UNAPPROVED DRUG OTHER Hospira, Inc. WATER 1 mL/mL N 20181231 0409-1610_97221408-bacb-4cbc-bb09-7b9fec7fa3f9 0409-1610 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION PERINEURAL 20051130 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 0409-1623_5b7f62ee-abac-4d4e-bcbd-748d58641243 0409-1623 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050923 ANDA ANDA074626 Hospira, Inc. BUTORPHANOL TARTRATE 1 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV N 20181231 0409-1626_3fe9c151-1006-4c62-9f83-1288431262cf 0409-1626 HUMAN PRESCRIPTION DRUG BUTORPHANOL TARTRATE butorphanol tartrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160211 ANDA ANDA074626 Hospira, Inc. BUTORPHANOL TARTRATE 2 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV N 20181231 0409-1626_5b7f62ee-abac-4d4e-bcbd-748d58641243 0409-1626 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051220 ANDA ANDA074626 Hospira, Inc. BUTORPHANOL TARTRATE 2 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV N 20181231 0409-1630_6bebaa22-3877-4406-91a7-0aec17ac07a9 0409-1630 HUMAN PRESCRIPTION DRUG Atropine Sulfate ATROPINE SULFATE INJECTION, SOLUTION ENDOTRACHEAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20060119 NDA NDA021146 Hospira, Inc. ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0409-1631_9ee2f8c2-9dd1-4ce8-b58a-05bb25618f01 0409-1631 HUMAN PRESCRIPTION DRUG Calcium Chloride CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050914 NDA NDA021117 Hospira, Inc. CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0409-1632_ea43d6c8-bbe6-4ef7-a7cd-3eb59e221628 0409-1632 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060228 ANDA ANDA075164 Hospira, Inc. VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0409-1634_ea43d6c8-bbe6-4ef7-a7cd-3eb59e221628 0409-1634 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060303 ANDA ANDA075164 Hospira, Inc. VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0409-1638_72a75b3c-bc8d-47c3-b571-3376506799e5 0409-1638 HUMAN PRESCRIPTION DRUG Precedex DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20041130 NDA NDA021038 Hospira, Inc. DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 0409-1639_a5ce1cc0-9a24-4ffb-9c13-03fed1baa019 0409-1639 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060131 ANDA ANDA075241 Hospira, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0409-1660_72a75b3c-bc8d-47c3-b571-3376506799e5 0409-1660 HUMAN PRESCRIPTION DRUG Precedex DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20130408 NDA NDA021038 Hospira, Inc. DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 0409-1746_97221408-bacb-4cbc-bb09-7b9fec7fa3f9 0409-1746 HUMAN PRESCRIPTION DRUG Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050912 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 0409-1749_97221408-bacb-4cbc-bb09-7b9fec7fa3f9 0409-1749 HUMAN PRESCRIPTION DRUG Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL; PERINEURAL 20050912 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 0409-1752_97221408-bacb-4cbc-bb09-7b9fec7fa3f9 0409-1752 HUMAN PRESCRIPTION DRUG Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20060206 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 0409-1754_26c189d2-603e-4ca4-bef1-7178faa57c13 0409-1754 HUMAN PRESCRIPTION DRUG Magnesium Sulfate magnesium sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061128 ANDA ANDA075151 Hospira, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 0409-1755_97221408-bacb-4cbc-bb09-7b9fec7fa3f9 0409-1755 HUMAN PRESCRIPTION DRUG Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION PERINEURAL 20060322 NDA NDA016964 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 0409-1761_2292e626-adbf-492f-ab35-343b42c04be3 0409-1761 HUMAN PRESCRIPTION DRUG Marcaine Spinal Bupivacaine Hydrochloride in Dextrose INJECTION, SOLUTION SUBARACHNOID 20050519 NDA NDA018692 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-1775_e3b8bf71-2e60-439f-8475-458d0b6aa900 0409-1775 HUMAN PRESCRIPTION DRUG Dextrose Dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 20060222 NDA NDA019445 Hospira, Inc. DEXTROSE MONOHYDRATE 250 mg/mL N 20181231 0409-1778_6d3cc3cb-16bd-4689-a25b-8c76efb59550 0409-1778 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate METOPROLOL TARTRATE INJECTION, SOLUTION INTRAVENOUS 20080724 ANDA ANDA078085 Hospira, Inc. METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0409-1778_bf887179-1c71-4264-8227-e9cb10bbd82b 0409-1778 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate METOPROLOL TARTRATE INJECTION, SOLUTION INTRAVENOUS 20051012 ANDA ANDA074133 Hospira, Inc. METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0409-1782_708cb6a9-c27c-403b-89f5-a34934472ebf 0409-1782 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050923 ANDA ANDA070172 Hospira, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 0409-1886_365f040e-44c9-4553-b8d3-a83008ac9294 0409-1886 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM INJECTION, SOLUTION INTRAVENOUS 20121102 ANDA ANDA202869 Hospira, Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 0409-1890_507ed206-cf6e-4666-8fa9-d4970cf4867a 0409-1890 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120823 NDA NDA202515 Hospira, Inc. MORPHINE SULFATE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1891_507ed206-cf6e-4666-8fa9-d4970cf4867a 0409-1891 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120807 NDA NDA202515 Hospira, Inc. MORPHINE SULFATE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1892_507ed206-cf6e-4666-8fa9-d4970cf4867a 0409-1892 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120924 NDA NDA202515 Hospira, Inc. MORPHINE SULFATE 8 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1893_507ed206-cf6e-4666-8fa9-d4970cf4867a 0409-1893 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120820 NDA NDA202515 Hospira, Inc. MORPHINE SULFATE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-1902_57fd8c16-b3b2-466e-98ea-2c2ca12da21c 0409-1902 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060308 ANDA ANDA089069 Hospira, Inc. PROCAINAMIDE HYDROCHLORIDE 100 mg/mL Antiarrhythmic [EPC] N 20181231 0409-1902_d676ae3e-a0ba-4860-8824-b11c5a5d2c5c 0409-1902 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140701 ANDA ANDA089069 Hospira, Inc. PROCAINAMIDE HYDROCHLORIDE 100 mg/mL Antiarrhythmic [EPC] N 20181231 0409-1903_57fd8c16-b3b2-466e-98ea-2c2ca12da21c 0409-1903 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050829 ANDA ANDA089070 Hospira, Inc. PROCAINAMIDE HYDROCHLORIDE 500 mg/mL Antiarrhythmic [EPC] N 20181231 0409-1903_d676ae3e-a0ba-4860-8824-b11c5a5d2c5c 0409-1903 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141223 ANDA ANDA089070 Hospira, Inc. PROCAINAMIDE HYDROCHLORIDE 500 mg/mL Antiarrhythmic [EPC] N 20181231 0409-1918_3566d9fc-aad1-47e2-a562-fdc3718b978b 0409-1918 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050228 NDA NDA018803 Hospira, Inc. SODIUM CHLORIDE 9 mg/mL N 20181231 0409-1932_c800c118-aa5e-48db-ad6b-5f8113980b97 0409-1932 HUMAN PRESCRIPTION DRUG Adenosine ADENOSINE INJECTION, SOLUTION INTRAVENOUS 20140402 ANDA ANDA203883 Hospira, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 0409-1941_f28dd0b1-f8a9-44fa-b7b1-89a4e7bc93a6 0409-1941 HUMAN PRESCRIPTION DRUG Talwin PENTAZOCINE LACTATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20051118 NDA NDA016194 Hospira, Inc. PENTAZOCINE LACTATE 30 mg/mL Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV N 20191231 0409-1966_d487d87b-0490-421a-a73f-8e1977c79441 0409-1966 HUMAN PRESCRIPTION DRUG BACTERIOSTATIC SODIUM CHLORIDE SODIUM CHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050430 NDA NDA018800 Hospira, Inc. SODIUM CHLORIDE 9 mg/mL N 20181231 0409-1985_b7370a5d-135f-4bdc-894e-81472dc89198 0409-1985 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050606 ANDA ANDA074243 Hospira, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-2012_3f59ad84-8359-4e75-854d-0e6d641590f4 0409-2012 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Buprenorphine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050614 ANDA ANDA074137 Hospira, Inc. BUPRENORPHINE HYDROCHLORIDE .3 mg/mL Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 0409-2025_2a5bc36a-2778-42de-844b-9e9c5e218075 0409-2025 HUMAN PRESCRIPTION DRUG DOBUTamine DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20051117 ANDA ANDA074292 Hospira, Inc. DOBUTAMINE HYDROCHLORIDE 12.5 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20181231 0409-2028_ee99d46c-362a-44d7-9ea3-6bfdb1068845 0409-2028 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20061128 NDA NDA019917 Hospira, Inc. MORPHINE SULFATE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-2029_ee99d46c-362a-44d7-9ea3-6bfdb1068845 0409-2029 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20061128 NDA NDA019916 Hospira, Inc. MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-2047_a309b6ad-094e-49d5-ab55-7de9dc8814ae 0409-2047 HUMAN PRESCRIPTION DRUG Carbocaine Mepivacaine Hydrochloride INJECTION, SOLUTION INFILTRATION 20060927 NDA NDA012250 Hospira, Inc. MEPIVACAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-2051_80dbd0eb-8c4d-4b1b-8722-497177d58ec7 0409-2051 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA074549 Hospira, Inc. KETAMINE HYDROCHLORIDE 100 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 0409-2053_80dbd0eb-8c4d-4b1b-8722-497177d58ec7 0409-2053 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride KETAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA074549 Hospira, Inc. KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 0409-2066_c71dfd94-7f98-4bed-92bf-e7ca96cb1f78 0409-2066 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050907 ANDA ANDA040078 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-2122_e6dc115e-1410-428b-8b85-e96d191f2f71 0409-2122 HUMAN PRESCRIPTION DRUG ENALAPRILAT ENALAPRILAT INJECTION, SOLUTION INTRAVENOUS 20050824 ANDA ANDA075458 Hospira, Inc. ENALAPRILAT 1.25 mg/mL Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0409-2168_260da94a-a8ad-463e-b787-df38bb306d95 0409-2168 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050331 ANDA ANDA202411 Hospira, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0409-2265_72245812-5df9-43dd-bcc6-91ded8d829a4 0409-2265 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20000828 ANDA ANDA075220 Hospira, Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 0409-2265_e2133b89-2a7d-4da7-a2ba-d2965275ae7e 0409-2265 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20150101 ANDA ANDA075220 Hospira, Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 0409-2266_bcbe32e9-5795-4a2b-b3df-53340c34390a 0409-2266 HUMAN PRESCRIPTION DRUG Alfentanil Hydrochloride Alfentanil Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20060220 ANDA ANDA075221 Hospira, Inc. ALFENTANIL HYDROCHLORIDE 500 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-2267_4ded6eb1-795f-4611-9430-8b90fe5199d3 0409-2267 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20051230 ANDA ANDA075240 Hospira, Inc. LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0409-2267_fec24c53-7807-4bc0-ab9a-4246921468f0 0409-2267 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130722 ANDA ANDA075240 Hospira, Inc. LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0409-2285_bf887179-1c71-4264-8227-e9cb10bbd82b 0409-2285 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate METOPROLOL TARTRATE INJECTION, SOLUTION INTRAVENOUS 20060201 ANDA ANDA075160 Hospira, Inc. METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0409-2287_2dc1ae28-b110-408c-a374-aa56c2962146 0409-2287 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050428 ANDA ANDA074993 Hospira, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0409-2287_cfe37dfd-34af-48c5-b0d8-870ba671c959 0409-2287 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19990127 ANDA ANDA074993 Hospira, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0409-2290_a843be56-ee30-41ff-945b-021b76fad0fa 0409-2290 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050505 ANDA ANDA040140 Hospira, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0409-2304_9d4afc95-f504-417b-aa34-e789fe790cf2 0409-2304 HUMAN PRESCRIPTION DRUG Corlopam FENOLDOPAM MESYLATE INJECTION, SOLUTION INTRAVENOUS 20050228 NDA NDA019922 Hospira, Inc. FENOLDOPAM MESYLATE 10 mg/mL Dopamine Agonists [MoA],Dopaminergic Agonist [EPC] N 20181231 0409-2305_18c3f314-6d8d-4a84-b8b3-19b41cd7ff9b 0409-2305 HUMAN PRESCRIPTION DRUG MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050803 ANDA ANDA075857 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-2305_770f7698-e023-46ad-b6d8-eb1949d1cfe7 0409-2305 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050817 ANDA ANDA075857 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-2306_2503b569-5214-473a-b0b9-22645d8f7a85 0409-2306 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110118 ANDA ANDA075856 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-2306_bdc23e65-ab3a-434d-b4bf-b805db874ca4 0409-2306 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050331 ANDA ANDA075856 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-2307_bdc23e65-ab3a-434d-b4bf-b805db874ca4 0409-2307 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050503 ANDA ANDA075856 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-2308_18c3f314-6d8d-4a84-b8b3-19b41cd7ff9b 0409-2308 HUMAN PRESCRIPTION DRUG MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051121 ANDA ANDA075857 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-2308_770f7698-e023-46ad-b6d8-eb1949d1cfe7 0409-2308 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050614 ANDA ANDA075857 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-2336_6780d57f-ba00-4928-9203-2877b414467f 0409-2336 HUMAN PRESCRIPTION DRUG Deferoxamine Mesylate Deferoxamine Mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050430 ANDA ANDA076019 Hospira, Inc. DEFEROXAMINE MESYLATE 500 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] N 20181231 0409-2336_c0bdb051-84ce-427f-ad15-4b5d5cd56798 0409-2336 HUMAN PRESCRIPTION DRUG Deferoxamine Mesylate Deferoxamine Mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20040317 ANDA ANDA076019 Hospira, Inc. DEFEROXAMINE MESYLATE 500 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] N 20181231 0409-2337_6780d57f-ba00-4928-9203-2877b414467f 0409-2337 HUMAN PRESCRIPTION DRUG Deferoxamine Mesylate Deferoxamine Mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050331 ANDA ANDA076019 Hospira, Inc. DEFEROXAMINE MESYLATE 2 g/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] N 20181231 0409-2337_c0bdb051-84ce-427f-ad15-4b5d5cd56798 0409-2337 HUMAN PRESCRIPTION DRUG Deferoxamine Mesylate Deferoxamine Mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20040317 ANDA ANDA076019 Hospira, Inc. DEFEROXAMINE MESYLATE 2 g/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] N 20181231 0409-2339_3efd816a-4e42-4bb4-9800-e1cf20254e41 0409-2339 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20051018 ANDA ANDA075239 Hospira, Inc. LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0409-2344_76192b3f-794c-4923-8cbf-07a308832763 0409-2344 HUMAN PRESCRIPTION DRUG DOBUTAMINE DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050430 ANDA ANDA074086 Hospira, Inc. DOBUTAMINE HYDROCHLORIDE 12.5 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20191231 0409-2344_b5dec858-ad56-4691-8c7c-8fc236bfd894 0409-2344 HUMAN PRESCRIPTION DRUG DOBUTAMINE DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050629 ANDA ANDA074086 Hospira, Inc. DOBUTAMINE HYDROCHLORIDE 12.5 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20191231 0409-2346_2c7c70f4-b7f8-4936-9374-03eb3679eb1f 0409-2346 HUMAN PRESCRIPTION DRUG DOBUTamine Hydrochloride in Dextrose DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050812 NDA NDA020201 Hospira, Inc. DOBUTAMINE HYDROCHLORIDE 100 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20181231 0409-2347_2c7c70f4-b7f8-4936-9374-03eb3679eb1f 0409-2347 HUMAN PRESCRIPTION DRUG DOBUTamine Hydrochloride in Dextrose DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20060120 NDA NDA020201 Hospira, Inc. DOBUTAMINE HYDROCHLORIDE 200 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20181231 0409-2540_e06a7c74-0af2-4fc7-8a55-0cccd949bdaa 0409-2540 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-2552_e06a7c74-0af2-4fc7-8a55-0cccd949bdaa 0409-2552 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-2585_54c4ca00-3209-4c18-b475-2bf50e57e73e 0409-2585 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20070509 ANDA ANDA065345 Hospira, Inc CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-2587_5f4771b8-097c-48ca-b9b0-007598940e78 0409-2587 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060202 ANDA ANDA075293 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-2587_8afb1d5f-08b7-40e9-9f52-f665ef1c5d10 0409-2587 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060309 ANDA ANDA075293 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-2596_5f4771b8-097c-48ca-b9b0-007598940e78 0409-2596 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051103 ANDA ANDA075293 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-2596_8afb1d5f-08b7-40e9-9f52-f665ef1c5d10 0409-2596 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050930 ANDA ANDA075293 Hospira, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-2634_77e90af1-257e-47b9-9ec0-ffcc3d02299b 0409-2634 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20080731 ANDA ANDA078591 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-2689_3c56585c-efc1-4795-97b7-7b65f60d0e59 0409-2689 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060725 ANDA ANDA065310 Hospira, Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0409-2720_d00e37b1-ca1f-42fc-a027-e31d4e399085 0409-2720 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090831 ANDA ANDA090571 Hospira, Inc. HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20191231 0409-2721_d00e37b1-ca1f-42fc-a027-e31d4e399085 0409-2721 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090831 ANDA ANDA090571 Hospira, Inc. HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20191231 0409-2723_d00e37b1-ca1f-42fc-a027-e31d4e399085 0409-2723 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090831 ANDA ANDA090571 Hospira, Inc. HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20191231 0409-2776_54b38f92-f26b-4a52-bbeb-0ef650a296cc 0409-2776 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION, SOLUTION INTRAVENOUS 20050624 ANDA ANDA075885 Hospira, Inc. MILRINONE LACTATE 200 ug/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0409-2987_3c56585c-efc1-4795-97b7-7b65f60d0e59 0409-2987 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060725 ANDA ANDA065310 Hospira, Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0409-2988_f4539aaa-197c-479a-be29-c9821fc60db0 0409-2988 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060725 ANDA ANDA065241 Hospira, Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/4mL; g/4mL beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 0409-2998_f4539aaa-197c-479a-be29-c9821fc60db0 0409-2998 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060725 ANDA ANDA065241 Hospira, Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/8mL; g/8mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20191231 0409-2999_7cdd286c-3d70-4774-99ef-9e716b994850 0409-2999 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20161214 ANDA ANDA203557 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 12; 1.5 g/60mL; g/60mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0409-3177_301b290f-31ad-495b-85d4-16b59d8b0a65 0409-3177 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20051101 ANDA ANDA089635 Hospira, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-3178_301b290f-31ad-495b-85d4-16b59d8b0a65 0409-3178 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20050916 ANDA ANDA089644 Hospira, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 10; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-3181_301b290f-31ad-495b-85d4-16b59d8b0a65 0409-3181 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050131 ANDA ANDA089645 Hospira, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 15; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-3182_301b290f-31ad-495b-85d4-16b59d8b0a65 0409-3182 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20050623 ANDA ANDA089646 Hospira, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 20; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-3183_301b290f-31ad-495b-85d4-16b59d8b0a65 0409-3183 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050706 ANDA ANDA089651 Hospira, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 20; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-3213_400895b6-77e0-4f8f-b0f7-9e2069888777 0409-3213 HUMAN PRESCRIPTION DRUG Diazepam DIAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20071005 ANDA ANDA071583 Hospira, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-3213_8a7061d0-20a9-4751-bc77-b0479b069b79 0409-3213 HUMAN PRESCRIPTION DRUG Diazepam DIAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160211 ANDA ANDA071583 Hospira, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-3294_535a901b-2ddb-4b2f-9428-3e62388801c2 0409-3294 HUMAN PRESCRIPTION DRUG Potassium Acetate POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20131223 NDA NDA018896 Hospira, Inc. POTASSIUM ACETATE 196.3 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-3294_cd46bac2-f70a-4b18-b2cc-d5c19b01ac60 0409-3294 HUMAN PRESCRIPTION DRUG Potassium Acetate POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050705 NDA NDA018896 Hospira, Inc. POTASSIUM ACETATE 196.3 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-3299_0561a64f-a146-4a1c-be64-dea50e4ac856 0409-3299 HUMAN PRESCRIPTION DRUG Sodium Acetate sodium acetate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20131119 NDA NDA018893 Hospira, Inc. SODIUM ACETATE ANHYDROUS 164 mg/mL N 20181231 0409-3299_53ae2c3c-c98c-40a1-be29-2ccdfe730849 0409-3299 HUMAN PRESCRIPTION DRUG Sodium Acetate sodium acetate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050430 NDA NDA018893 Hospira, Inc. SODIUM ACETATE ANHYDROUS 164 mg/mL N 20181231 0409-3307_b77ce5ce-2a84-42ec-a066-aec1b4b3e8a4 0409-3307 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20050430 ANDA ANDA073664 Hospira, Inc. ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 0409-3308_b77ce5ce-2a84-42ec-a066-aec1b4b3e8a4 0409-3308 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20050601 ANDA ANDA074037 Hospira, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 0409-3356_e06a7c74-0af2-4fc7-8a55-0cccd949bdaa 0409-3356 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-3365_e06a7c74-0af2-4fc7-8a55-0cccd949bdaa 0409-3365 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20111201 NDA NDA200403 Hospira, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-3374_9713c063-02eb-4b40-8fcd-a77343426801 0409-3374 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065363 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0409-3375_4991ee2d-32a9-4827-850f-4c799d9320f2 0409-3375 HUMAN PRESCRIPTION DRUG LEVOPHED NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130628 NDA NDA007513 Hospira, Inc. NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-3375_62843afc-9ddd-4087-aeea-43f6fb198f7b 0409-3375 HUMAN PRESCRIPTION DRUG LEVOPHED NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090427 NDA NDA007513 Hospira, Inc. NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-3378_9713c063-02eb-4b40-8fcd-a77343426801 0409-3378 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065363 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0409-3379_9713c063-02eb-4b40-8fcd-a77343426801 0409-3379 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065363 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0409-3380_a2d5e728-44a4-47c6-be77-8cd5a21591b6 0409-3380 HUMAN PRESCRIPTION DRUG Sufentanil Citrate SUFENTANIL CITRATE INJECTION, SOLUTION EPIDURAL; INTRAVENOUS 20050907 ANDA ANDA074534 Hospira, Inc. SUFENTANIL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0409-3382_a2d5e728-44a4-47c6-be77-8cd5a21591b6 0409-3382 HUMAN PRESCRIPTION DRUG Sufentanil Citrate SUFENTANIL CITRATE INJECTION, SOLUTION EPIDURAL; INTRAVENOUS 20050726 ANDA ANDA074534 Hospira, Inc. SUFENTANIL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0409-3382_cf5ba77b-d9cd-4cc3-8380-55c1c5ace585 0409-3382 HUMAN PRESCRIPTION DRUG Sufentanil Citrate SUFENTANIL CITRATE INJECTION, SOLUTION EPIDURAL; INTRAVENOUS 20050726 ANDA ANDA074534 Hospira, Inc. SUFENTANIL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0409-3383_15dbfd27-16ea-48dc-b24c-d1b837479b84 0409-3383 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0409-3385_15dbfd27-16ea-48dc-b24c-d1b837479b84 0409-3385 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0409-3390_15dbfd27-16ea-48dc-b24c-d1b837479b84 0409-3390 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Hospira, Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0409-3400_d816e357-f397-4dad-b84e-5754ac530b44 0409-3400 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19860220 ANDA ANDA062612 Hospira, Inc. GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0409-3401_d816e357-f397-4dad-b84e-5754ac530b44 0409-3401 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19860220 ANDA ANDA062612 Hospira, Inc. GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0409-3402_d816e357-f397-4dad-b84e-5754ac530b44 0409-3402 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate GENTAMICIN SULFATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19860220 ANDA ANDA062612 Hospira, Inc. GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0409-3414_1524af3d-8d40-4301-a361-11018f15da1b 0409-3414 HUMAN PRESCRIPTION DRUG Metoclopramide metoclopramide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19910117 ANDA ANDA073118 Hospira, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20191231 0409-3505_8b533a87-dd9d-475f-96c7-834332588431 0409-3505 HUMAN PRESCRIPTION DRUG Meropenem MEROPENEM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100624 ANDA ANDA090940 Hospira, Inc. MEROPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 0409-3506_8b533a87-dd9d-475f-96c7-834332588431 0409-3506 HUMAN PRESCRIPTION DRUG Meropenem MEROPENEM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100624 ANDA ANDA090940 Hospira, Inc. MEROPENEM 1 g/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 0409-3507_aaeaafc1-33ae-438f-822c-3ce25f725aaa 0409-3507 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin Imipenem and Cilastatin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111117 ANDA ANDA090825 Hospira, Inc. IMIPENEM; CILASTATIN SODIUM 500; 500 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] N 20191231 0409-3508_aaeaafc1-33ae-438f-822c-3ce25f725aaa 0409-3508 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin Imipenem and Cilastatin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111116 ANDA ANDA090825 Hospira, Inc. IMIPENEM; CILASTATIN SODIUM 250; 250 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] N 20191231 0409-3578_55b0de88-5336-4cd3-baea-9b26157237af 0409-3578 HUMAN PRESCRIPTION DRUG Tobramycin TOBRAMYCIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050505 ANDA ANDA063111 Hospira, Inc. TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 0409-3613_ad9d6166-f51e-4507-b416-ef491132c89f 0409-3613 HUMAN PRESCRIPTION DRUG Bupivacaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION SUBARACHNOID 20050131 ANDA ANDA071810 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-3713_d769861b-c994-4a5a-857a-585d00f919d9 0409-3713 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19840802 ANDA ANDA062527 Hospira, Inc NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0409-3714_d769861b-c994-4a5a-857a-585d00f919d9 0409-3714 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19840802 ANDA ANDA062527 Hospira, Inc NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0409-3715_018842f5-294e-44fe-aeeb-86920faf1a58 0409-3715 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19840802 ANDA ANDA062527 Hospira, Inc NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0409-3718_3d1c4b4d-18e2-4e8f-9701-badaa462c733 0409-3718 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Hospira, Inc AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0409-3719_3d1c4b4d-18e2-4e8f-9701-badaa462c733 0409-3719 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Hospira, Inc AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0409-3720_3d1c4b4d-18e2-4e8f-9701-badaa462c733 0409-3720 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Hospira, Inc AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0409-3724_2c7c70f4-b7f8-4936-9374-03eb3679eb1f 0409-3724 HUMAN PRESCRIPTION DRUG DOBUTamine Hydrochloride in Dextrose DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20051012 NDA NDA020201 Hospira, Inc. DOBUTAMINE HYDROCHLORIDE 400 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20181231 0409-3725_2fdfe288-f851-4c3d-a542-9f20d6af2b1d 0409-3725 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Hospira, Inc AMPICILLIN SODIUM 10 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0409-3726_3d1c4b4d-18e2-4e8f-9701-badaa462c733 0409-3726 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Hospira, Inc AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0409-3793_73fa0f7c-e974-4378-922b-ba8bfe789fc2 0409-3793 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050606 ANDA ANDA074802 Hospira, Inc. KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0409-3795_73fa0f7c-e974-4378-922b-ba8bfe789fc2 0409-3795 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060119 ANDA ANDA074802 Hospira, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0409-3796_73fa0f7c-e974-4378-922b-ba8bfe789fc2 0409-3796 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20151030 ANDA ANDA074802 Hospira, Inc. KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0409-3814_817aba2b-0e4c-4f08-a52a-decc3f11e6ef 0409-3814 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL; INTRAVENOUS 20050810 ANDA ANDA073509 Hospira, Inc. MORPHINE SULFATE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-3815_817aba2b-0e4c-4f08-a52a-decc3f11e6ef 0409-3815 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL; INTRAVENOUS 20050629 ANDA ANDA073510 Hospira, Inc. MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-3977_630729df-2593-497e-9fd4-9ce7e93bed5d 0409-3977 HUMAN PRESCRIPTION DRUG Bacteriostatic Water WATER SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050430 NDA NDA018802 Hospira, Inc. WATER 1 mL/mL N 20181231 0409-4011_f3995079-7b9f-4ca7-9e3a-1d93b645e558 0409-4011 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050228 ANDA ANDA070738 Hospira, Inc. VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0409-4031_48bfb4b7-7f48-479e-8f0f-09e746e34fa6 0409-4031 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 20041130 NDA NDA016269 Hospira, Inc. MANNITOL 12.5 g/50mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] N 20181231 0409-4090_c6418e26-4e62-49bc-b3c8-f027e5815bc4 0409-4090 HUMAN PRESCRIPTION DRUG ZINC ZINC CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19900930 NDA NDA018959 Hospira, Inc. ZINC CHLORIDE 1 mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 0409-4091_0419e899-0d30-481f-be21-116372e0c22b 0409-4091 HUMAN PRESCRIPTION DRUG MANGANESE MANGANESE CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050131 NDA NDA018962 Hospira, Inc. MANGANESE CHLORIDE .1 mg/mL Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20191231 0409-4092_830d3311-f51e-48ab-818e-86195f0748a5 0409-4092 HUMAN PRESCRIPTION DRUG COPPER CUPRIC CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19860626 NDA NDA018960 Hospira, Inc. CUPRIC CHLORIDE .4 mg/mL N 20181231 0409-4093_18f76470-71f2-4a35-912a-cd923bfa6520 0409-4093 HUMAN PRESCRIPTION DRUG Chromium Chromic Chloride INJECTION, SOLUTION INTRAVENOUS 20160427 NDA NDA018961 Hospira, Inc. CHROMIC CHLORIDE 4 ug/mL N 20181231 0409-4093_d374ba41-6d10-4127-9626-fb18ff934866 0409-4093 HUMAN PRESCRIPTION DRUG CHROMIUM CHROMIC CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050630 NDA NDA018961 Hospira, Inc. CHROMIC CHLORIDE 4 ug/mL N 20181231 0409-4162_035eb1a0-d767-4dbf-8f4a-6ea72f9a3cb5 0409-4162 HUMAN PRESCRIPTION DRUG Aminosyn II ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYL-TYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 20050729 NDA NDA019438 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE 561; 850; 893; 146; 253; 340; 170; 425; 844; 865; 595; 627; 255; 614; 450; 230; 425 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0409-4164_035eb1a0-d767-4dbf-8f4a-6ea72f9a3cb5 0409-4164 HUMAN PRESCRIPTION DRUG Aminosyn II ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYL-TYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 20050901 NDA NDA019438 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE 660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0409-4166_7106cc84-ca68-4b75-a5f2-e3682ecec1fe 0409-4166 HUMAN PRESCRIPTION DRUG Aminosyn RF ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ARGININE, and HISTIDINE INJECTION, SOLUTION INTRAVENOUS 20110218 NDA NDA018429 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ARGININE; HISTIDINE 462; 726; 535; 726; 726; 330; 165; 528; 600; 429 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 0409-4168_2ab1b1d5-3dc8-4b14-8730-b21bc0f9c845 0409-4168 HUMAN PRESCRIPTION DRUG Aminosyn Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, And Glycine INJECTION, SOLUTION INTRAVENOUS 20100819 NDA NDA019374 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE 789; 1576; 265; 206; 228; 272; 88; 789; 660; 507; 154; 448; 221; 33; 660 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0409-4171_22b05e52-f67f-4820-958a-e017032194aa 0409-4171 HUMAN PRESCRIPTION DRUG Aminosyn II with Electrolytes ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, VALINE, ASPARTIC ACID, N-ACETYL-TYROSINE, GLUTAMIC ACID, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19860403 NDA NDA019437 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; GLYCINE; VALINE; ASPARTIC ACID; N-ACETYLTYROSINE; GLUTAMIC ACID; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM CHLORIDE; POTASSIUM CHLORIDE 561; 850; 893; 146; 253; 340; 170; 844; 865; 255; 614; 450; 425; 425; 595; 230; 627; 102; 425; 60; 492 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-4178_1b15a302-faa0-41b3-b8f8-1f4966707211 0409-4178 HUMAN PRESCRIPTION DRUG Aminosyn-PF ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE INJECTION, SOLUTION INTRAVENOUS 19850906 NDA NDA019398 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; PROLINE; SERINE; TAURINE; TYROSINE 534; 831; 475; 125; 300; 360; 125; 452; 490; 861; 370; 576; 270; 220; 570; 347; 50; 44 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0409-4179_c6bb7871-42d5-4393-98fe-bcc1454dd6aa 0409-4179 HUMAN PRESCRIPTION DRUG Aminosyn-PF ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, and TYROSINE INJECTION, SOLUTION INTRAVENOUS 19861017 NDA NDA019492 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; PROLINE; SERINE; TAURINE; TYROSINE 760; 1200; 677; 180; 427; 512; 180; 673; 698; 1227; 527; 820; 385; 312; 812; 495; 70; 44 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0409-4187_dad76e26-0274-4501-abaf-216a4165a2ae 0409-4187 HUMAN PRESCRIPTION DRUG Aminosyn ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 20120306 NDA NDA017673 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE 620; 810; 624; 340; 380; 460; 150; 680; 1100; 850; 260; 750; 370; 44; 1100 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0409-4191_dad76e26-0274-4501-abaf-216a4165a2ae 0409-4191 HUMAN PRESCRIPTION DRUG Aminosyn ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 20120306 NDA NDA017673 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE 720; 940; 720; 400; 440; 520; 160; 800; 1280; 980; 300; 860; 420; 44; 1280 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0409-4192_87246041-7204-4de1-862f-856e646b37e5 0409-4192 HUMAN PRESCRIPTION DRUG Aminosyn Sulfite Free ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 20111027 NDA NDA017673 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE 720; 940; 720; 400; 440; 520; 160; 800; 1280; 980; 300; 860; 420; 44; 1280 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] E 20171231 0409-4196_3d4922c0-c757-4756-88b0-c02ce8a66743 0409-4196 HUMAN PRESCRIPTION DRUG Aminosyn ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, GLYCINE, SODIUM CHLORIDE, POTASSIUM ACETATE, PHOSPHORIC ACID, and MAGNESIUM ACETATE INJECTION, SOLUTION INTRAVENOUS 20110323 NDA NDA017789 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; POTASSIUM ACETATE; PHOSPHORIC ACID; MAGNESIUM ACETATE 252; 329; 252; 140; 154; 182; 56; 280; 448; 343; 105; 300; 147; 31; 448; 234; 128; 40; 21 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0409-4200_3d4922c0-c757-4756-88b0-c02ce8a66743 0409-4200 HUMAN PRESCRIPTION DRUG Aminosyn ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, GLYCINE, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110323 NDA NDA017789 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM CHLORIDE 510; 660; 510; 280; 310; 370; 120; 560; 900; 690; 210; 610; 300; 44; 900; 28; 102; 425; 487 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-4203_3d4922c0-c757-4756-88b0-c02ce8a66743 0409-4203 HUMAN PRESCRIPTION DRUG Aminosyn ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, GLYCINE, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110323 NDA NDA017673 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM CHLORIDE 620; 810; 624; 340; 380; 460; 150; 680; 1100; 850; 260; 750; 370; 44; 1100; 28; 102; 425; 487 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-4215_cdaad3f9-4f38-4a37-9c09-b8d4ff76c5e4 0409-4215 HUMAN PRESCRIPTION DRUG ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20171019 ANDA ANDA090621 Hospira, Inc. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0409-4228_f861b22c-53af-4f6a-97c1-fac17b4dbdf3 0409-4228 HUMAN PRESCRIPTION DRUG ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTION, SOLUTION INTRAVENOUS 20171019 ANDA ANDA202837 Hospira, Inc. ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0409-4229_530ce577-bfc3-4c22-934f-9be798876cfe 0409-4229 HUMAN PRESCRIPTION DRUG Zoledronic Acid ZOLEDRONIC ACID INJECTION, SOLUTION INTRAVENOUS 20171019 NDA NDA204016 Hospira, Inc. ZOLEDRONIC ACID 4 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0409-4265_6055eb0c-5c9f-423c-b36e-d3e96738e3bb 0409-4265 HUMAN PRESCRIPTION DRUG DOPamine Hydrochloride Dopamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19810519 NDA NDA018132 Hospira, Inc. DOPAMINE HYDROCHLORIDE 80 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-4275_7ec395d4-2494-4831-8a67-c2ac8d200506 0409-4275 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20060104 ANDA ANDA088325 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-4276_7ec395d4-2494-4831-8a67-c2ac8d200506 0409-4276 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20050712 ANDA ANDA088299 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-4277_7ec395d4-2494-4831-8a67-c2ac8d200506 0409-4277 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20050615 ANDA ANDA088327 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-4278_7ec395d4-2494-4831-8a67-c2ac8d200506 0409-4278 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; INTRAVENOUS 20050630 ANDA ANDA088328 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-4279_7ec395d4-2494-4831-8a67-c2ac8d200506 0409-4279 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050830 ANDA ANDA088329 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-4282_7ec395d4-2494-4831-8a67-c2ac8d200506 0409-4282 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050914 ANDA ANDA088294 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-4283_09648df1-b16d-42a1-9548-7808e3143db6 0409-4283 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION RETROBULBAR; TOPICAL 20050609 ANDA ANDA088295 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-4332_a4c6bab2-855d-4938-b176-bbd8f53be11c 0409-4332 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050430 ANDA ANDA062911 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0409-4346_379e13e8-8775-4b06-bbf9-1473b7cb7cfd 0409-4346 HUMAN PRESCRIPTION DRUG Aminocaproic Acid AMINOCAPROIC ACID INJECTION, SOLUTION INTRAVENOUS 20100512 ANDA ANDA070010 Hospira, Inc. AMINOCAPROIC ACID 250 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 0409-4346_7cdf4748-f8de-4db1-9a0f-115dac658c7d 0409-4346 HUMAN PRESCRIPTION DRUG AMINOCAPROIC ACID aminocaproic acid INJECTION, SOLUTION INTRAVENOUS 20141104 ANDA ANDA070010 Hospira, Inc. AMINOCAPROIC ACID 250 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 0409-4350_2b11f984-77c0-4377-a8e8-7d3d2986d139 0409-4350 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050430 ANDA ANDA075853 Hospira, Inc. DILTIAZEM HYDROCHLORIDE 100 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 0409-4646_6e93c25d-3750-46d3-8954-b9489db7c1be 0409-4646 HUMAN PRESCRIPTION DRUG Pancuronium Bromide Pancuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20051011 ANDA ANDA072320 Hospira, Inc. PANCURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0409-4646_9344c9f7-5707-44a4-a7eb-00c58ef11639 0409-4646 HUMAN PRESCRIPTION DRUG Pancuronium Bromide Pancuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20051011 ANDA ANDA072320 Hospira, Inc. PANCURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0409-4684_4bca19c6-6394-4751-87c3-80199e1eaa36 0409-4684 HUMAN PRESCRIPTION DRUG Fluconazole in Dextrose Fluconazole in Dextrose INJECTION, SOLUTION INTRAVENOUS 20060419 ANDA ANDA076304 Hospira, Inc. FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 0409-4688_159c8aff-99e7-4051-946a-36c6d5ad7023 0409-4688 HUMAN PRESCRIPTION DRUG Fluconazole in Sodium Chloride Fluconazole in Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20060417 ANDA ANDA076303 Hospira, Inc. FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 0409-4699_2479b268-34ce-493b-aa23-ebfe27d922aa 0409-4699 HUMAN PRESCRIPTION DRUG PROPOFOL PROPOFOL INJECTION, EMULSION INTRAVENOUS 20060403 ANDA ANDA077908 Hospira, Inc. PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 0409-4712_a074d6ac-4ba9-44d2-8e52-5f1684de9cf7 0409-4712 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Dextrose lidocaine hydrochloride and dextrose INJECTION, SOLUTION INTRASPINAL 20050622 ANDA ANDA083914 Hospira, Inc. LIDOCAINE HYDROCHLORIDE; DEXTROSE MONOHYDRATE 50; 75 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0409-4713_7ec395d4-2494-4831-8a67-c2ac8d200506 0409-4713 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050708 ANDA ANDA080408 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-4755_dad98bf5-2f37-49f1-a732-69973048bc00 0409-4755 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20081016 ANDA ANDA077548 Hospira, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 0409-4759_dad98bf5-2f37-49f1-a732-69973048bc00 0409-4759 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061107 ANDA ANDA077473 Hospira, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 0409-4776_7ec395d4-2494-4831-8a67-c2ac8d200506 0409-4776 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20060106 ANDA ANDA080408 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 15 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-4777_901e314b-facb-4342-842e-d65bc0aa2217 0409-4777 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN INJECTION, SOLUTION INTRAVENOUS 20080319 ANDA ANDA077753 Hospira, Inc. CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 0409-4777_93b7b313-e89e-4ac6-b636-3d6d953e6e5f 0409-4777 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN INJECTION, SOLUTION INTRAVENOUS 20080703 ANDA ANDA077753 Hospira, Inc. CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 0409-4882_e9bf09df-54a5-4bfe-a1ed-101fea5ead5f 0409-4882 HUMAN PRESCRIPTION DRUG Linezolid LINEZOLID INJECTION, SOLUTION INTRAVENOUS 20150707 20180701 ANDA ANDA205442 Hospira, Inc. LINEZOLID 2 mg/mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0409-4883_14b348af-66ee-4e95-a824-c6768235228f 0409-4883 HUMAN PRESCRIPTION DRUG Linezolid LINEZOLID INJECTION, SOLUTION INTRAVENOUS 20150618 NDA NDA206473 Hospira, Inc. LINEZOLID 2 mg/mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0409-4887_002cbef2-e839-4ecd-b18c-a83f51cf955b 0409-4887 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050616 NDA NDA018801 Hospira, Inc. WATER 1 mL/mL N 20181231 0409-4888_3566d9fc-aad1-47e2-a562-fdc3718b978b 0409-4888 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050228 NDA NDA018803 Hospira, Inc. SODIUM CHLORIDE 9 mg/mL N 20181231 0409-4900_2b8db15d-a1e6-4d9f-bcfa-f9ee73283339 0409-4900 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20060221 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE 84 mg/mL N 20191231 0409-4902_38dc9311-1046-4644-9e55-e7c342c5746f 0409-4902 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20051207 UNAPPROVED DRUG OTHER Hospira, Inc. DEXTROSE MONOHYDRATE 25 g/50mL N 20191231 0409-4903_14fbd3bf-15ff-4c70-9cb3-3f7239bfc1a1 0409-4903 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20051201 ANDA ANDA083158 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-4904_14fbd3bf-15ff-4c70-9cb3-3f7239bfc1a1 0409-4904 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050830 ANDA ANDA083158 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-4910_9991bebb-7a72-470a-9df4-4c227d285190 0409-4910 HUMAN PRESCRIPTION DRUG ATROPINE SULFATE ATROPINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20050825 UNAPPROVED DRUG OTHER Hospira, Inc. ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 0409-4911_9991bebb-7a72-470a-9df4-4c227d285190 0409-4911 HUMAN PRESCRIPTION DRUG ATROPINE SULFATE ATROPINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20051025 UNAPPROVED DRUG OTHER Hospira, Inc. ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 0409-4916_2b8db15d-a1e6-4d9f-bcfa-f9ee73283339 0409-4916 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20060216 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE 75 mg/mL N 20191231 0409-4921_0dfc1cb4-8ea6-4a26-986e-05b63d4ebd86 0409-4921 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION ENDOTRACHEAL; INTRACARDIAC; INTRAVENOUS 20051222 UNAPPROVED DRUG OTHER Hospira, Inc. EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-4928_5c645cd9-1eff-4918-b7ea-a8f12e7f7e41 0409-4928 HUMAN PRESCRIPTION DRUG Calcium Chloride CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS; INTRAVENTRICULAR 20060124 UNAPPROVED DRUG OTHER Hospira, Inc. CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20191231 0409-5082_8202f0e8-9c89-426e-8dc7-fec2160a50f7 0409-5082 HUMAN PRESCRIPTION DRUG TAZICEF CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051102 ANDA ANDA062662 Hospira, Inc. CEFTAZIDIME 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-5084_8202f0e8-9c89-426e-8dc7-fec2160a50f7 0409-5084 HUMAN PRESCRIPTION DRUG TAZICEF CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20051216 ANDA ANDA062662 Hospira, Inc. CEFTAZIDIME 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-5086_da199712-23c0-4c96-92dd-bf837ed0ff83 0409-5086 HUMAN PRESCRIPTION DRUG TAZICEF CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060420 ANDA ANDA062662 Hospira, Inc. CEFTAZIDIME 6 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-5092_b6d2d567-72d5-4287-94e5-f63e8683f0ce 0409-5092 HUMAN PRESCRIPTION DRUG TAZICEF CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060508 ANDA ANDA064032 Hospira, Inc. CEFTAZIDIME 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-5093_b6d2d567-72d5-4287-94e5-f63e8683f0ce 0409-5093 HUMAN PRESCRIPTION DRUG TAZICEF CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060405 ANDA ANDA064032 Hospira, Inc. CEFTAZIDIME 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-5534_2b8db15d-a1e6-4d9f-bcfa-f9ee73283339 0409-5534 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20051212 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE 42 mg/mL N 20191231 0409-5779_b5792e3c-3774-4099-a5e9-3523f66f3d08 0409-5779 HUMAN PRESCRIPTION DRUG TPN Electrolytes SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, and SODIUM ACETATE ANHYDROUS INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050228 NDA NDA018895 Hospira, Inc. SODIUM CHLORIDE; CALCIUM CHLORIDE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE ANHYDROUS 321; 331; 1491; 508; 2420 mg/20mL; mg/20mL; mg/20mL; mg/20mL; mg/20mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-5820_6055eb0c-5c9f-423c-b36e-d3e96738e3bb 0409-5820 HUMAN PRESCRIPTION DRUG DOPamine Hydrochloride Dopamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19810519 NDA NDA018132 Hospira, Inc. DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-5921_a232763a-3f57-43e0-acfc-7572ac207797 0409-5921 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline INJECTION, SOLUTION INTRAVENOUS 20050510 ANDA ANDA087242 Hospira, Inc. AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0409-5921_b6cd15a3-a4d5-444b-9dfc-19f4b1d46de1 0409-5921 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline INJECTION, SOLUTION INTRAVENOUS 20150624 ANDA ANDA087242 Hospira, Inc. AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0409-5922_a232763a-3f57-43e0-acfc-7572ac207797 0409-5922 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline INJECTION, SOLUTION INTRAVENOUS 20050228 ANDA ANDA087242 Hospira, Inc. AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0409-6028_ee99d46c-362a-44d7-9ea3-6bfdb1068845 0409-6028 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20060502 NDA NDA019916 Hospira, Inc. MORPHINE SULFATE 5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-6030_8c6e7b1a-3ee2-4ece-a862-5c94098e52c4 0409-6030 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20050902 ANDA ANDA088432 Hospira, Inc. MEPERIDINE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0409-6102_8f46a25d-ad0d-48ff-911b-9d28cc288e37 0409-6102 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131119 NDA NDA018667 Hospira, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0409-6102_a5ce1cc0-9a24-4ffb-9c13-03fed1baa019 0409-6102 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050228 NDA NDA018667 Hospira, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0409-6138_348d1f2b-9945-4323-8c8f-dfef6eee78be 0409-6138 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE IRRIGANT IRRIGATION 20050523 NDA NDA017514 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-6139_ccbd6241-bd51-4895-8461-c77904a0867b 0409-6139 HUMAN PRESCRIPTION DRUG Sterile Water water IRRIGANT IRRIGATION 20050430 NDA NDA017513 Hospira, Inc. WATER 1 mL/mL N 20181231 0409-6140_7a6d4e9b-bdfb-4d3a-a2b0-7666dea0f682 0409-6140 HUMAN PRESCRIPTION DRUG Ringers SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE IRRIGANT IRRIGATION 20100621 NDA NDA017635 Hospira, Inc. SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE 860; 30; 33 mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0409-6141_9a44d861-5d5c-460e-8457-c91a7a419adc 0409-6141 HUMAN PRESCRIPTION DRUG Physiosol SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE IRRIGANT IRRIGATION 20110211 NDA NDA017637 Hospira, Inc. SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE 526; 222; 502; 37; 30 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0409-6143_dd9a3c93-1bfb-4d8d-9668-5533098af0fa 0409-6143 HUMAN PRESCRIPTION DRUG Acetic Acid Acetic Acid IRRIGANT IRRIGATION 19800101 NDA NDA017656 Hospira, Inc. ACETIC ACID 250 mg/100mL N 20181231 0409-6476_ace29818-99a3-4aa4-b08f-a96fd3e0a8d2 0409-6476 HUMAN PRESCRIPTION DRUG Erythrocin Lactobionate ERYTHROMYCIN LACTOBIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060316 ANDA ANDA062638 Hospira, Inc. ERYTHROMYCIN LACTOBIONATE 500 mg/100mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 0409-6482_30b5f10e-c498-4ffd-86b8-f5228f892461 0409-6482 HUMAN PRESCRIPTION DRUG Erythrocin Lactobionate ERYTHROMYCIN LACTOBIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050525 NDA NDA050609 Hospira, Inc. ERYTHROMYCIN LACTOBIONATE 500 mg/10mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0409-6509_44e1fb49-2a7f-4149-acc9-27d362047c71 0409-6509 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050606 ANDA ANDA063076 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0409-6510_21a3a6dc-dc41-47b5-9b00-1d6e0d4d60e3 0409-6510 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090506 ANDA ANDA065455 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 100 mg/mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0409-6531_5a34277b-c23d-4754-95b7-1b9aeed75c39 0409-6531 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120323 ANDA ANDA062933 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 750 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0409-6531_a4c6bab2-855d-4938-b176-bbd8f53be11c 0409-6531 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090327 ANDA ANDA062912 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 750 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0409-6533_a4c6bab2-855d-4938-b176-bbd8f53be11c 0409-6533 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050331 ANDA ANDA062912 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 1 g/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0409-6534_5a34277b-c23d-4754-95b7-1b9aeed75c39 0409-6534 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050616 ANDA ANDA062931 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0409-6535_5a34277b-c23d-4754-95b7-1b9aeed75c39 0409-6535 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050430 ANDA ANDA062933 Hospira, Inc. VANCOMYCIN HYDROCHLORIDE 1 g/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0409-6557_007ae1d0-2b44-4f14-88c5-9d511e62d2e5 0409-6557 HUMAN PRESCRIPTION DRUG Testosterone Cypionate testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 20160801 ANDA ANDA085635 Hospira, Inc. TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0409-6562_007ae1d0-2b44-4f14-88c5-9d511e62d2e5 0409-6562 HUMAN PRESCRIPTION DRUG Testosterone Cypionate testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 20160801 ANDA ANDA085635 Hospira, Inc. TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20191231 0409-6562_4f0336d6-2753-47ea-84d0-d31b46d60bff 0409-6562 HUMAN PRESCRIPTION DRUG Testosterone Cypionate testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 20180117 ANDA ANDA085635 Hospira, Inc. TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20191231 0409-6609_34d7b582-1a3c-4908-b411-73517bf9c99d 0409-6609 HUMAN PRESCRIPTION DRUG Neut Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20050822 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE .2 g/5mL N 20181231 0409-6609_3b35b803-2487-4eab-af90-787df8bf445a 0409-6609 HUMAN PRESCRIPTION DRUG Neut Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20140503 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE .2 g/5mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-6625_2b8db15d-a1e6-4d9f-bcfa-f9ee73283339 0409-6625 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20050331 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE 84 mg/mL N 20191231 0409-6625_e91511e1-8b96-4786-8e10-001d9be56333 0409-6625 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20140313 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE 84 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0409-6629_8ae66f81-311d-41c1-9a8b-0d8c27e7ac69 0409-6629 HUMAN PRESCRIPTION DRUG Quelicin Succinylcholine Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050430 NDA NDA008845 Hospira, Inc. SUCCINYLCHOLINE CHLORIDE 20 mg/mL Depolarizing Neuromuscular Blocker [EPC],Neuromuscular Depolarizing Blockade [PE] N 20181231 0409-6629_c59c7284-e212-43b8-8c02-808a11bfbed0 0409-6629 HUMAN PRESCRIPTION DRUG Quelicin Succinylcholine Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140331 NDA NDA008845 Hospira, Inc. SUCCINYLCHOLINE CHLORIDE 20 mg/mL Depolarizing Neuromuscular Blocker [EPC],Neuromuscular Depolarizing Blockade [PE] N 20181231 0409-6635_57ba080c-cc7b-4e02-8c83-7510e039bbf1 0409-6635 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050919 ANDA ANDA080205 Hospira, Inc. POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-6637_2b8db15d-a1e6-4d9f-bcfa-f9ee73283339 0409-6637 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20060117 UNAPPROVED DRUG OTHER Hospira, Inc. SODIUM BICARBONATE 84 mg/mL N 20191231 0409-6648_38dc9311-1046-4644-9e55-e7c342c5746f 0409-6648 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20050331 NDA NDA019445 Hospira, Inc. DEXTROSE MONOHYDRATE 25 g/50mL N 20191231 0409-6651_57ba080c-cc7b-4e02-8c83-7510e039bbf1 0409-6651 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20051110 ANDA ANDA080205 Hospira, Inc. POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-6653_57ba080c-cc7b-4e02-8c83-7510e039bbf1 0409-6653 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050808 ANDA ANDA080205 Hospira, Inc. POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-6657_0939f986-7d52-4894-b631-970ddcacd465 0409-6657 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20051018 NDA NDA018897 Hospira, Inc. SODIUM CHLORIDE 2.92 g/20mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-6660_0939f986-7d52-4894-b631-970ddcacd465 0409-6660 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050729 NDA NDA018897 Hospira, Inc. SODIUM CHLORIDE 5.84 g/40mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-6664_3acebc84-6521-4fe2-a9a2-52c2b2cb2b26 0409-6664 HUMAN PRESCRIPTION DRUG Sodium Lactate SODIUM LACTATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060628 NDA NDA018947 Hospira, Inc. SODIUM LACTATE 5.6 g/10mL N 20181231 0409-6695_58043cb4-ccb1-425a-8c49-d491218013dc 0409-6695 HUMAN PRESCRIPTION DRUG AMIDATE etomidate INJECTION, SOLUTION INTRAVENOUS 20160128 NDA NDA018227 Hospira, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 0409-6695_5f448664-0779-46c3-8594-270244861174 0409-6695 HUMAN PRESCRIPTION DRUG Amidate ETOMIDATE INJECTION, SOLUTION INTRAVENOUS 20050726 NDA NDA018227 Hospira, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 0409-6727_605ae33d-aea5-49da-b236-42f55a915e7c 0409-6727 HUMAN PRESCRIPTION DRUG Magnesium Sulfate in Dextrose MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAVENOUS 20050927 NDA NDA020488 Hospira, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 10 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0409-6729_4c6a5714-4c0b-47a1-acdd-3e179a67a670 0409-6729 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAVENOUS 20050822 NDA NDA020309 Hospira, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 4 g/100mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 0409-6730_4c6a5714-4c0b-47a1-acdd-3e179a67a670 0409-6730 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAVENOUS 20060331 NDA NDA020309 Hospira, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 4 g/50mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 0409-6778_ea125121-c52b-4c46-96b8-4c1c4d2d0a28 0409-6778 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060131 ANDA ANDA074282 Hospira, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-6779_ea125121-c52b-4c46-96b8-4c1c4d2d0a28 0409-6779 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060104 ANDA ANDA074282 Hospira, Inc. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-6780_ea125121-c52b-4c46-96b8-4c1c4d2d0a28 0409-6780 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060103 ANDA ANDA074282 Hospira, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-6781_ea125121-c52b-4c46-96b8-4c1c4d2d0a28 0409-6781 HUMAN PRESCRIPTION DRUG Lorazepam LORAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060130 20180401 ANDA ANDA074282 Hospira, Inc. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0409-7074_04ef4884-2c4e-4dfa-95bf-b0bb9ca56dcd 0409-7074 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19921130 NDA NDA020161 Hospira, Inc. POTASSIUM CHLORIDE 10 meq/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7075_04ef4884-2c4e-4dfa-95bf-b0bb9ca56dcd 0409-7075 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19921130 NDA NDA020161 Hospira, Inc. POTASSIUM CHLORIDE 200 meq/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7076_04ef4884-2c4e-4dfa-95bf-b0bb9ca56dcd 0409-7076 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19921130 NDA NDA020161 Hospira, Inc. POTASSIUM CHLORIDE 30 meq/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7077_04ef4884-2c4e-4dfa-95bf-b0bb9ca56dcd 0409-7077 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19921130 NDA NDA020161 Hospira, Inc. POTASSIUM CHLORIDE 400 meq/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7100_c3a9890f-2c87-4e8a-9243-817fee89d626 0409-7100 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 20050627 NDA NDA019466 Hospira, Inc. DEXTROSE MONOHYDRATE 50 mg/mL N 20181231 0409-7101_0b86c10b-0268-47cb-8278-05d48a2d09fa 0409-7101 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20050630 NDA NDA019465 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7107_634f8071-e3a8-4962-a225-a70be07759ad 0409-7107 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20041231 NDA NDA019691 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 50; 9; 1.49 g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7109_634f8071-e3a8-4962-a225-a70be07759ad 0409-7109 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050331 NDA NDA019691 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 50; 9; 2.98 g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7111_693e1e2d-8a3c-4983-8e21-80a490935d94 0409-7111 HUMAN PRESCRIPTION DRUG Potassium Chloride in Lactated Ringers and Dextrose POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19881017 NDA NDA019685 Hospira, Inc. POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; SODIUM LACTATE; DEXTROSE MONOHYDRATE 1.79; 6; .2; 3.1; 50 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7113_693e1e2d-8a3c-4983-8e21-80a490935d94 0409-7113 HUMAN PRESCRIPTION DRUG Potassium Chloride in Lactated Ringers and Dextrose POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19881017 NDA NDA019685 Hospira, Inc. POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; SODIUM LACTATE; DEXTROSE MONOHYDRATE 3.28; 6; .2; 3.1; 50 g/mL; g/mL; g/mL; g/mL; g/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7115_9b7424a1-6632-4609-a7dd-b4ed8703c3af 0409-7115 HUMAN PRESCRIPTION DRUG Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19881017 NDA NDA019686 Hospira, Inc. SODIUM CHLORIDE; POTASSIUM CHLORIDE 9; 1.49 g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7116_9b7424a1-6632-4609-a7dd-b4ed8703c3af 0409-7116 HUMAN PRESCRIPTION DRUG Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19881017 NDA NDA019686 Hospira, Inc. SODIUM CHLORIDE; POTASSIUM CHLORIDE 9; 2.98 g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7118_17b6e9f7-966a-4ff7-9403-d26f759a44c0 0409-7118 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION, SOLUTION INTRAVENOUS 20050803 NDA NDA019869 Hospira, Inc. WATER 1 mL/mL N 20181231 0409-7120_20e71f82-6a07-4b0e-92cf-677ee720bc09 0409-7120 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 20050701 NDA NDA019893 Hospira, Inc. DEXTROSE MONOHYDRATE 70 g/100mL N 20181231 0409-7121_d35d54e3-7e26-4c98-8fee-f88ce2eac095 0409-7121 HUMAN PRESCRIPTION DRUG Aminosyn II ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 19911219 NDA NDA020015 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE 660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] E 20171231 0409-7132_0b86c10b-0268-47cb-8278-05d48a2d09fa 0409-7132 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20050913 NDA NDA019759 Hospira, Inc. SODIUM CHLORIDE 450 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7138_348d1f2b-9945-4323-8c8f-dfef6eee78be 0409-7138 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE IRRIGANT IRRIGATION 20050513 NDA NDA017514 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7139_ccbd6241-bd51-4895-8461-c77904a0867b 0409-7139 HUMAN PRESCRIPTION DRUG Sterile Water water IRRIGANT IRRIGATION 20050331 NDA NDA017513 Hospira, Inc. WATER 1 mL/mL N 20181231 0409-7171_9072c9b0-4ce9-45ce-8510-8df848da63bd 0409-7171 HUMAN PRESCRIPTION DRUG Aminosyn II ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 19911219 NDA NDA020041 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE 990; 1500; 1575; 258; 447; 600; 300; 750; 1490; 1527; 1050; 1107; 450; 1083; 795; 405; 750 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0409-7172_9072c9b0-4ce9-45ce-8510-8df848da63bd 0409-7172 HUMAN PRESCRIPTION DRUG Aminosyn II ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE INJECTION, SOLUTION INTRAVENOUS 19911219 NDA NDA020015 Hospira, Inc. ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE 660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 0409-7241_00bcc0aa-15a5-4d78-ae86-2bd42cf9e228 0409-7241 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20130812 UNAPPROVED DRUG OTHER Hospira, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-7241_091ebde6-57a2-44ab-8cc5-30c4831005bf 0409-7241 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20060501 UNAPPROVED DRUG OTHER Hospira, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-7241_2a0b5490-8091-41af-8d88-822aa38ca767 0409-7241 HUMAN PRESCRIPTION DRUG EPINEPHRINE epinephrine INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20050901 UNAPPROVED DRUG OTHER Hospira, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-7248_25e5dcb2-4a6b-4d84-b4f1-da17f0931bff 0409-7248 HUMAN PRESCRIPTION DRUG HETASTARCH IN SODIUM CHLORIDE HETASTARCH INJECTION, SOLUTION INTRAVENOUS 20050526 ANDA BA740193 Hospira, Inc. HETASTARCH 6 g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient] N 20181231 0409-7248_dc530441-b645-4afa-9e3c-375409664b7f 0409-7248 HUMAN PRESCRIPTION DRUG Hetastarch in Sodium Chloride HETASTARCH INJECTION, SOLUTION INTRAVENOUS 19950130 ANDA BA740193 Hospira, Inc. HETASTARCH 6 g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [Chemical/Ingredient] N 20181231 0409-7295_a5a805c5-d00a-43c3-bc2b-c87caf9f3d89 0409-7295 HUMAN PRESCRIPTION DRUG Potassium Phosphates POTASSIUM PHOSPHATE, MONOBASIC and POTASSIUM PHOSPHATE, DIBASIC INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19840917 UNAPPROVED DRUG OTHER Hospira, Inc. POTASSIUM PHOSPHATE, MONOBASIC; DIBASIC POTASSIUM PHOSPHATE 224; 236 mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7295_b8049560-cb4b-414f-8311-30589575e414 0409-7295 HUMAN PRESCRIPTION DRUG Potassium Phosphates POTASSIUM PHOSPHATE, MONOBASIC and POTASSIUM PHOSPHATE, DIBASIC INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140701 UNAPPROVED DRUG OTHER Hospira, Inc. POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC 224; 236 mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7299_ca69a615-a5a3-4a4b-ad96-64c9fd2b94c8 0409-7299 HUMAN PRESCRIPTION DRUG Sodium Acetate SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140305 NDA NDA018893 Hospira, Inc. SODIUM ACETATE ANHYDROUS 3.28 g/20mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7299_e1cb21bf-b5d7-4d26-9a4f-ccb3ddb63da4 0409-7299 HUMAN PRESCRIPTION DRUG Sodium Acetate SODIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050331 NDA NDA018893 Hospira, Inc. SODIUM ACETATE ANHYDROUS 3.28 g/20mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7332_a44f6acb-1875-436b-bcac-b7e1ef68b30c 0409-7332 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Hospira, Inc CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-7333_076769b8-6ef7-446f-9a5a-00cacbccb203 0409-7333 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050503 ANDA ANDA065204 Hospira, Inc CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-7333_1d8e23b8-f5ce-44da-b1d0-e5a5afb38d9a 0409-7333 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050503 ANDA ANDA065204 Hospira, Inc CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-7334_f908f8b6-7649-4346-a221-a3e94299cf54 0409-7334 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050517 ANDA ANDA065168 Hospira, Inc CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-7335_a44f6acb-1875-436b-bcac-b7e1ef68b30c 0409-7335 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Hospira, Inc CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-7336_076769b8-6ef7-446f-9a5a-00cacbccb203 0409-7336 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050503 ANDA ANDA065204 Hospira, Inc CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-7336_1d8e23b8-f5ce-44da-b1d0-e5a5afb38d9a 0409-7336 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050503 ANDA ANDA065204 Hospira, Inc CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-7337_a44f6acb-1875-436b-bcac-b7e1ef68b30c 0409-7337 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Hospira, Inc CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-7338_a44f6acb-1875-436b-bcac-b7e1ef68b30c 0409-7338 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Hospira, Inc CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0409-7372_95fb784f-3181-451c-9747-0c9bbd356be3 0409-7372 HUMAN PRESCRIPTION DRUG Ionosol MB and Dextrose DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, and SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20050430 NDA NDA019513 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 5; 260; 141; 30; 15; 25 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7385_a232763a-3f57-43e0-acfc-7572ac207797 0409-7385 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline INJECTION, SOLUTION INTRAVENOUS 20060110 ANDA ANDA087242 Hospira, Inc. AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0409-7386_a232763a-3f57-43e0-acfc-7572ac207797 0409-7386 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline INJECTION, SOLUTION INTRAVENOUS 20051213 ANDA ANDA087242 Hospira, Inc. AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0409-7391_c8cbcd2d-9d3a-470e-8201-00c24e7b85c7 0409-7391 HUMAN PRESCRIPTION DRUG Sodium Phosphates SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE and SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INJECTION, SOLUTION INTRAVENOUS 20050602 NDA NDA018892 Hospira, Inc. SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 276; 142 mg/mL; mg/mL N 20181231 0409-7418_d73450a5-90e4-4fd4-aa0e-44d4dcbd6c17 0409-7418 HUMAN PRESCRIPTION DRUG LMD in Dextrose DEXTRAN 40 INJECTION, SOLUTION INTRAVENOUS 19921030 ANDA BA720563 Hospira, Inc. DEXTRAN 40 10 g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA] N 20181231 0409-7419_d73450a5-90e4-4fd4-aa0e-44d4dcbd6c17 0409-7419 HUMAN PRESCRIPTION DRUG LMD in Sodium Chloride DEXTRAN 40 INJECTION, SOLUTION INTRAVENOUS 19921030 ANDA BA720562 Hospira, Inc. DEXTRAN 40 10 g/100mL Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA] N 20181231 0409-7517_38dc9311-1046-4644-9e55-e7c342c5746f 0409-7517 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20050801 NDA NDA019445 Hospira, Inc. DEXTROSE MONOHYDRATE 25 g/50mL N 20191231 0409-7620_e588f69a-85db-46fe-afc8-ad0010f18774 0409-7620 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20050331 NDA NDA018916 Hospira, Inc. HEPARIN SODIUM 200 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0409-7650_6bd740e2-3e40-4007-b47b-9b7747a74cb8 0409-7650 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20050630 NDA NDA018916 Hospira, Inc. HEPARIN SODIUM 10000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0409-7651_6bd740e2-3e40-4007-b47b-9b7747a74cb8 0409-7651 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20050621 NDA NDA018916 Hospira, Inc. HEPARIN SODIUM 5000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0409-7670_1ddca328-933a-4812-a4e0-70b69a11a7bd 0409-7670 HUMAN PRESCRIPTION DRUG Normosol-R SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20101004 NDA NDA017586 Hospira, Inc. SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE 526; 222; 502; 37; 30 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0409-7714_48bfb4b7-7f48-479e-8f0f-09e746e34fa6 0409-7714 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 20050831 NDA NDA019603 Hospira, Inc. MANNITOL 15 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] N 20181231 0409-7715_48bfb4b7-7f48-479e-8f0f-09e746e34fa6 0409-7715 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 20050919 NDA NDA019603 Hospira, Inc. MANNITOL 20 g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] N 20181231 0409-7730_5cfe5cca-4976-44bd-b091-3365da10adef 0409-7730 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19790404 NDA NDA018090 Hospira, Inc. SODIUM CHLORIDE 450 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7793_70447183-3217-458a-bac1-833708589864 0409-7793 HUMAN PRESCRIPTION DRUG Heparin Sodium and Dextrose HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20051025 NDA NDA019339 Hospira, Inc. HEPARIN SODIUM 10000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0409-7809_92bb6656-1755-415e-8153-35a506866876 0409-7809 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride and Dextrose DOPAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050430 NDA NDA018826 Hospira, Inc. DOPAMINE HYDROCHLORIDE 1.6 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-7810_92bb6656-1755-415e-8153-35a506866876 0409-7810 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride and Dextrose DOPAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050808 NDA NDA018826 Hospira, Inc. DOPAMINE HYDROCHLORIDE 3.2 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-7811_3b645a32-8541-4f85-83f1-8cb0d157abd7 0409-7811 HUMAN PRESCRIPTION DRUG Metronidazole METRONIDAZOLE INJECTION, SOLUTION INTRAVENOUS 20050907 NDA NDA018890 Hospira, Inc. METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0409-7811_be0d659b-f924-4c2e-87a0-dad2d2532606 0409-7811 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE INJECTION, SOLUTION INTRAVENOUS 20160316 NDA NDA018890 Hospira, Inc. METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0409-7828_ba0a32de-8521-49e7-aaf0-b84648dddb4f 0409-7828 HUMAN PRESCRIPTION DRUG Lactated Ringers SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE IRRIGANT IRRIGATION 20050516 NDA NDA019416 Hospira, Inc. SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE 600; 310; 30; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0409-7901_634f8071-e3a8-4962-a225-a70be07759ad 0409-7901 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050330 NDA NDA018365 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 50; 2.25; 1.49 g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7902_634f8071-e3a8-4962-a225-a70be07759ad 0409-7902 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050131 NDA NDA018362 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 50; 4.5; 1.49 g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7903_634f8071-e3a8-4962-a225-a70be07759ad 0409-7903 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20051101 NDA NDA018362 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 50; 4.5; 2.24 g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7904_634f8071-e3a8-4962-a225-a70be07759ad 0409-7904 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050603 NDA NDA018362 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 50; 4.5; 2.98 g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7905_43152199-496d-4be2-bf34-5b82b6240dc6 0409-7905 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose DEXTROSE MONOHYDRATE and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018371 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE 5; .149 g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7906_43152199-496d-4be2-bf34-5b82b6240dc6 0409-7906 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose DEXTROSE MONOHYDRATE and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018371 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE 5; .298 g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 0409-7918_cd548e8c-30ec-454b-8342-f746660d9064 0409-7918 HUMAN PRESCRIPTION DRUG Dextrose dextrose INJECTION, SOLUTION INTRAVENOUS 20050714 NDA NDA018561 Hospira, Inc. DEXTROSE MONOHYDRATE 70 g/100mL N 20181231 0409-7922_cf8cc343-d0b0-4f33-af86-045c9c647b18 0409-7922 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 20050909 NDA NDA016367 Hospira, Inc. DEXTROSE MONOHYDRATE 5 g/100mL N 20181231 0409-7922_eaa3f466-6a43-40bb-a09e-36ab9b3685c3 0409-7922 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 20050228 NDA NDA016367 Hospira, Inc. DEXTROSE MONOHYDRATE 5 g/100mL N 20181231 0409-7923_cf8cc343-d0b0-4f33-af86-045c9c647b18 0409-7923 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 20050909 NDA NDA016367 Hospira, Inc. DEXTROSE MONOHYDRATE 5 g/100mL N 20181231 0409-7923_eaa3f466-6a43-40bb-a09e-36ab9b3685c3 0409-7923 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 20050331 NDA NDA016367 Hospira, Inc. DEXTROSE MONOHYDRATE 5 g/100mL N 20181231 0409-7924_8f538220-c2e5-43fb-96fc-a1747de11978 0409-7924 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050606 NDA NDA017606 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; .225 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7925_8f538220-c2e5-43fb-96fc-a1747de11978 0409-7925 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050608 NDA NDA017799 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; .3 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7926_8f538220-c2e5-43fb-96fc-a1747de11978 0409-7926 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050516 NDA NDA017607 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; .45 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7929_3b563647-dcc1-45ac-ab6a-14aefa2879e1 0409-7929 HUMAN PRESCRIPTION DRUG Lactated Ringers and Dextrose SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, and DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20050228 NDA NDA017608 Hospira, Inc. SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE 600; 310; 30; 20; 5 mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0409-7930_eaa3f466-6a43-40bb-a09e-36ab9b3685c3 0409-7930 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION, SOLUTION INTRAVENOUS 20050131 NDA NDA018080 Hospira, Inc. DEXTROSE MONOHYDRATE 10 g/100mL N 20181231 0409-7935_cd548e8c-30ec-454b-8342-f746660d9064 0409-7935 HUMAN PRESCRIPTION DRUG Dextrose dextrose INJECTION, SOLUTION INTRAVENOUS 20050912 NDA NDA018564 Hospira, Inc. DEXTROSE MONOHYDRATE 20 g/100mL N 20181231 0409-7936_cd548e8c-30ec-454b-8342-f746660d9064 0409-7936 HUMAN PRESCRIPTION DRUG Dextrose dextrose INJECTION, SOLUTION INTRAVENOUS 20050627 NDA NDA018563 Hospira, Inc. DEXTROSE MONOHYDRATE 50 g/100mL N 20181231 0409-7937_cd548e8c-30ec-454b-8342-f746660d9064 0409-7937 HUMAN PRESCRIPTION DRUG Dextrose dextrose INJECTION, SOLUTION INTRAVENOUS 20050822 NDA NDA018562 Hospira, Inc. DEXTROSE MONOHYDRATE 40 g/100mL N 20181231 0409-7938_df3681dd-0369-425d-8c1e-475d4b4862db 0409-7938 HUMAN PRESCRIPTION DRUG Dextrose dextrose monohydrate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050930 NDA NDA018080 Hospira, Inc. DEXTROSE MONOHYDRATE 10 g/100mL N 20181231 0409-7941_8f538220-c2e5-43fb-96fc-a1747de11978 0409-7941 HUMAN PRESCRIPTION DRUG Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE and SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050804 NDA NDA017585 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE 5; .9 g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7953_3b563647-dcc1-45ac-ab6a-14aefa2879e1 0409-7953 HUMAN PRESCRIPTION DRUG Lactated Ringers SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, and CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050331 NDA NDA017641 Hospira, Inc. SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE 600; 310; 30; 20 mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0409-7965_b028e290-8116-4fee-a7f1-f43cd0dc1eab 0409-7965 HUMAN PRESCRIPTION DRUG Normosol-M and Dextrose DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, and MAGNESIUM ACETATE INJECTION, SOLUTION INTRAVENOUS 19750813 NDA NDA017610 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM ACETATE; MAGNESIUM ACETATE 5; 234; 128; 21 g/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0409-7967_21b6f3b6-8ebe-4b6e-a58f-707cf77cf704 0409-7967 HUMAN PRESCRIPTION DRUG Normosol-R SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20100920 NDA NDA017586 Hospira, Inc. SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE 526; 222; 502; 37; 30 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0409-7968_c4dc9f87-79d3-4a95-b16e-27e02342a5a2 0409-7968 HUMAN PRESCRIPTION DRUG Normosol-R and Dextrose Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride INJECTION, SOLUTION INTRAVENOUS 20100916 NDA NDA017609 Hospira, Inc. DEXTROSE; SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE 5; 526; 222; 502; 37; 30 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0409-7969_049578a4-c148-4831-a3f1-9591e825923e 0409-7969 HUMAN PRESCRIPTION DRUG Plegisol POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE INJECTION, SOLUTION INTRA-ARTERIAL 20050728 NDA NDA018608 Hospira, Inc. POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 119.3; 643; 17.6; 325.3 mg/100mL; mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0409-7972_052bfca9-91e9-4d0e-baa7-adfd006d830f 0409-7972 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE IRRIGANT IRRIGATION 20050510 NDA NDA018314 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7972_348d1f2b-9945-4323-8c8f-dfef6eee78be 0409-7972 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE IRRIGANT IRRIGATION 20050328 NDA NDA018314 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7973_ccbd6241-bd51-4895-8461-c77904a0867b 0409-7973 HUMAN PRESCRIPTION DRUG Sterile Water water IRRIGANT IRRIGATION 20050331 NDA NDA018313 Hospira, Inc. WATER 1 mL/mL N 20181231 0409-7974_59b17b67-16c3-4e38-9862-f50b9975de8f 0409-7974 HUMAN PRESCRIPTION DRUG Glycine GLYCINE IRRIGANT IRRIGATION 20050727 NDA NDA018315 Hospira, Inc. GLYCINE 1.5 g/100mL N 20181231 0409-7981_21ea390d-ede6-449c-a4e6-e2756f6ca2ee 0409-7981 HUMAN PRESCRIPTION DRUG Sorbitol-Mannitol SORBITOL and MANNITOL IRRIGANT URETHRAL 20050524 NDA NDA018316 Hospira, Inc. SORBITOL; MANNITOL 2.7; .54 g/100mL; g/100mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] N 20181231 0409-7982_c1916a1b-6b4b-450c-8ce6-ab05556cb979 0409-7982 HUMAN PRESCRIPTION DRUG Ringers SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800516 NDA NDA018251 Hospira, Inc. POTASSIUM CHLORIDE; CALCIUM CHLORIDE; SODIUM CHLORIDE 30; 33; 860 mg/100mL; mg/100mL; mg/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7983_5cfe5cca-4976-44bd-b091-3365da10adef 0409-7983 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19720224 NDA NDA016366 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7983_ca013908-6d2b-4938-8ddb-f0eb8776ce30 0409-7983 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19720224 NDA NDA016366 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7984_5cfe5cca-4976-44bd-b091-3365da10adef 0409-7984 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19720224 NDA NDA016366 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7984_7069f07d-7c49-4738-9d89-8bf69505504a 0409-7984 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19720224 NDA NDA016366 Hospira, Inc. SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7985_5cfe5cca-4976-44bd-b091-3365da10adef 0409-7985 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19790404 NDA NDA018090 Hospira, Inc. SODIUM CHLORIDE 450 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7985_f950fafd-7856-4356-ae1b-b2d1a8926a7e 0409-7985 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19790404 NDA NDA018090 Hospira, Inc. SODIUM CHLORIDE 450 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7990_c9f9903d-36df-492b-b70f-9b065bf5ef3d 0409-7990 HUMAN PRESCRIPTION DRUG Sterile Water water INJECTION, SOLUTION INTRAVENOUS 20050830 NDA NDA018233 Hospira, Inc. WATER 1000 mL/1000mL N 20181231 0409-7991_634f8071-e3a8-4962-a225-a70be07759ad 0409-7991 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050929 NDA NDA018365 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 50; 2.25; 2.24 g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7992_634f8071-e3a8-4962-a225-a70be07759ad 0409-7992 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050929 NDA NDA018365 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 50; 2.25; 2.98 g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7993_634f8071-e3a8-4962-a225-a70be07759ad 0409-7993 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050228 NDA NDA018362 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 50; 4.5; .745 g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-7996_43152199-496d-4be2-bf34-5b82b6240dc6 0409-7996 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose DEXTROSE MONOHYDRATE and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 19800529 NDA NDA018371 Hospira, Inc. DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE 5; .224 g/100mL; g/100mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 0409-7998_634f8071-e3a8-4962-a225-a70be07759ad 0409-7998 HUMAN PRESCRIPTION DRUG Potassium Chloride in Dextrose and Sodium Chloride DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050228 NDA NDA018876 Hospira, Inc. DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 50; 3; 1.49 g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-8004_cd548e8c-30ec-454b-8342-f746660d9064 0409-8004 HUMAN PRESCRIPTION DRUG Dextrose dextrose INJECTION, SOLUTION INTRAVENOUS 20050728 NDA NDA019345 Hospira, Inc. DEXTROSE MONOHYDRATE 30 g/100mL N 20181231 0409-8060_5f448664-0779-46c3-8594-270244861174 0409-8060 HUMAN PRESCRIPTION DRUG Amidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20051007 NDA NDA018227 Hospira, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 0409-8183_7947cbf4-723d-4115-92a2-94a89ccea0e3 0409-8183 HUMAN PRESCRIPTION DRUG Potassium Acetate POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050707 NDA NDA018896 Hospira, Inc. POTASSIUM ACETATE 3.93 g/20mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-8183_ebea55c4-fcd1-4872-bd89-287c859b5c2d 0409-8183 HUMAN PRESCRIPTION DRUG Potassium Acetate POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140327 NDA NDA018896 Hospira, Inc. POTASSIUM ACETATE 3.93 g/20mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-8300_264eb68f-64f7-4d47-b158-c1544f3bbe29 0409-8300 HUMAN PRESCRIPTION DRUG Bivalirudin BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150730 ANDA ANDA090811 Hospira, Inc. BIVALIRUDIN 250 mg/1 Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 0409-8300_ff3a6b27-39c5-400a-8d83-3554b925cdba 0409-8300 HUMAN PRESCRIPTION DRUG Bivalirudin BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20151005 ANDA ANDA090816 Hospira, Inc. BIVALIRUDIN 250 mg/1 Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 0409-9042_434761e6-ce15-44c4-a40d-15d3afd5cb03 0409-9042 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050615 ANDA ANDA071165 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-9042_60a521fb-5c7d-4d75-93ff-4335f2a01ae8 0409-9042 HUMAN PRESCRIPTION DRUG BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE bupivacaine hydrochloride and epinephrine INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20151007 ANDA ANDA071165 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-9043_434761e6-ce15-44c4-a40d-15d3afd5cb03 0409-9043 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20051129 ANDA ANDA071167 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-9045_434761e6-ce15-44c4-a40d-15d3afd5cb03 0409-9045 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL; PERINEURAL 20050518 ANDA ANDA071168 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-9046_434761e6-ce15-44c4-a40d-15d3afd5cb03 0409-9046 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION PERINEURAL 20050726 ANDA ANDA071170 Hospira, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-9093_3d38fa81-2f15-48e7-9dcd-51a717791d9c 0409-9093 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE fentanyl citrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161206 NDA NDA019115 Hospira, Inc. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0409-9093_a8386c8b-4c0b-4834-87d0-47aa1213e97f 0409-9093 HUMAN PRESCRIPTION DRUG Fentanyl Citrate FENTANYL CITRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051115 NDA NDA019115 Hospira, Inc. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0409-9094_3d38fa81-2f15-48e7-9dcd-51a717791d9c 0409-9094 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE fentanyl citrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161206 NDA NDA019115 Hospira, Inc. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0409-9094_a8386c8b-4c0b-4834-87d0-47aa1213e97f 0409-9094 HUMAN PRESCRIPTION DRUG Fentanyl Citrate FENTANYL CITRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050927 NDA NDA019115 Hospira, Inc. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0409-9104_6055eb0c-5c9f-423c-b36e-d3e96738e3bb 0409-9104 HUMAN PRESCRIPTION DRUG DOPamine Hydrochloride Dopamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19810519 NDA NDA018132 Hospira, Inc. DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0409-9137_14fbd3bf-15ff-4c70-9cb3-3f7239bfc1a1 0409-9137 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20050706 ANDA ANDA040302 Hospira, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0409-9157_46520bb9-40c9-4901-99bc-4c76f5d924f4 0409-9157 HUMAN PRESCRIPTION DRUG Vitamin K1 PHYTONADIONE INJECTION, EMULSION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050622 ANDA ANDA087954 Hospira, Inc. PHYTONADIONE 2 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 0409-9157_e2fc84b2-0860-494b-b0c9-7585706f6dd9 0409-9157 HUMAN PRESCRIPTION DRUG Vitamin K1 PHYTONADIONE INJECTION, EMULSION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140626 ANDA ANDA087954 Hospira, Inc. PHYTONADIONE 2 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 0409-9158_46520bb9-40c9-4901-99bc-4c76f5d924f4 0409-9158 HUMAN PRESCRIPTION DRUG Vitamin K1 PHYTONADIONE INJECTION, EMULSION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050727 ANDA ANDA087955 Hospira, Inc. PHYTONADIONE 10 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 0409-9158_e2fc84b2-0860-494b-b0c9-7585706f6dd9 0409-9158 HUMAN PRESCRIPTION DRUG Vitamin K1 PHYTONADIONE INJECTION, EMULSION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140321 ANDA ANDA087955 Hospira, Inc. PHYTONADIONE 10 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 0409-9257_0d90e23e-cccf-49df-ac59-c9b90227337a 0409-9257 HUMAN PRESCRIPTION DRUG Potassium Chloride in Sodium Chloride SODIUM CHLORIDE and POTASSIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20081205 ANDA ANDA078446 Hospira, Inc. SODIUM CHLORIDE; POTASSIUM CHLORIDE 4.5; 1.49 g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0409-9300_128e32dc-9a4b-452c-8b49-a8dd57bf81e7 0409-9300 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20141107 ANDA ANDA090194 Hospira, Inc. ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-9301_128e32dc-9a4b-452c-8b49-a8dd57bf81e7 0409-9301 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20140923 ANDA ANDA090194 Hospira, Inc. ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-9302_128e32dc-9a4b-452c-8b49-a8dd57bf81e7 0409-9302 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; PERINEURAL 20140923 ANDA ANDA090194 Hospira, Inc. ROPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-9303_128e32dc-9a4b-452c-8b49-a8dd57bf81e7 0409-9303 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20140923 ANDA ANDA090194 Hospira, Inc. ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0409-9558_63912135-499a-4e11-ba3f-2f1da23af8b9 0409-9558 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20081201 ANDA ANDA078519 Hospira, Inc. ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0409-9558_e1b40e78-e408-4b91-9d04-4216035a29f9 0409-9558 HUMAN PRESCRIPTION DRUG ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTION, SOLUTION INTRAVENOUS 20081215 ANDA ANDA078519 Hospira, Inc. ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0409-9630_6bebaa22-3877-4406-91a7-0aec17ac07a9 0409-9630 HUMAN PRESCRIPTION DRUG Atropine Sulfate ATROPINE SULFATE INJECTION, SOLUTION ENDOTRACHEAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20041231 NDA NDA021146 Hospira, Inc. ATROPINE SULFATE .05 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0409-9631_a5ce1cc0-9a24-4ffb-9c13-03fed1baa019 0409-9631 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060420 ANDA ANDA075241 Hospira, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0409-9633_f3995079-7b9f-4ca7-9e3a-1d93b645e558 0409-9633 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20051202 ANDA ANDA075136 Hospira, Inc. VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0430-0005_fa9d3141-a8a8-409c-b158-0aa9e82beeb9 0430-0005 HUMAN PRESCRIPTION DRUG ESTROSTEP Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20050419 NDA NDA020130 Allergan, Inc. N 20181231 0430-0145_6619e651-5c17-4dd5-a641-83c0f329d828 0430-0145 HUMAN PRESCRIPTION DRUG femhrt norethindrone acetate/ethinyl estradiol TABLET ORAL 20091001 NDA NDA021065 Allergan, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL .5; 2.5 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0430-0170_130a7af0-15c9-478c-a8bb-938f608a0863 0430-0170 HUMAN PRESCRIPTION DRUG Enablex darifenacin TABLET, EXTENDED RELEASE ORAL 20041222 NDA NDA021513 Allergan, Inc. DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 0430-0171_130a7af0-15c9-478c-a8bb-938f608a0863 0430-0171 HUMAN PRESCRIPTION DRUG Enablex darifenacin TABLET, EXTENDED RELEASE ORAL 20041222 NDA NDA021513 Allergan, Inc. DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 0430-0210_456ef6d0-e4d9-47d1-9643-0e3984910d3b 0430-0210 HUMAN PRESCRIPTION DRUG SARAFEM fluoxetine hydrochloride TABLET ORAL 20080624 NDA NDA021860 Allergan, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0430-0220_456ef6d0-e4d9-47d1-9643-0e3984910d3b 0430-0220 HUMAN PRESCRIPTION DRUG SARAFEM fluoxetine hydrochloride TABLET ORAL 20080624 NDA NDA021860 Allergan, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0430-0420_97355bee-81c8-4f9a-8a33-67f798ae56f3 0430-0420 HUMAN PRESCRIPTION DRUG Lo Loestrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate KIT 20101201 NDA NDA022501 Allergan, Inc. N 20181231 0430-0470_6601a365-a4ea-430b-903b-b3139a944fa2 0430-0470 HUMAN PRESCRIPTION DRUG Actonel Risedronate Sodium TABLET, FILM COATED ORAL 19980327 NDA NDA020835 Allergan, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 25.8; 4.2 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0430-0471_6601a365-a4ea-430b-903b-b3139a944fa2 0430-0471 HUMAN PRESCRIPTION DRUG Actonel Risedronate Sodium TABLET, FILM COATED ORAL 20000414 NDA NDA020835 Allergan, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 4.3; .7 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0430-0472_6601a365-a4ea-430b-903b-b3139a944fa2 0430-0472 HUMAN PRESCRIPTION DRUG Actonel Risedronate Sodium TABLET, FILM COATED ORAL 20020517 NDA NDA020835 Allergan, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 30.1; 4.9 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0430-0478_6601a365-a4ea-430b-903b-b3139a944fa2 0430-0478 HUMAN PRESCRIPTION DRUG Actonel Risedronate Sodium TABLET, FILM COATED ORAL 20080422 NDA NDA020835 Allergan, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 129; 21 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0430-0530_19c0d56b-55e4-43df-a5a5-73b9777ae4c5 0430-0530 HUMAN PRESCRIPTION DRUG Loestrin 24 Fe norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20060301 NDA NDA021871 Allergan, Inc. N 20181231 0430-0535_0820f903-6d48-48c0-a257-db20dc3af83f 0430-0535 HUMAN PRESCRIPTION DRUG Minastrin 24 Fe norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20130614 NDA NDA203667 Warner Chilcott (US), LLC E 20171231 0430-0537_4daf2d43-3a7e-446e-acf5-c8c6e3b3f016 0430-0537 HUMAN PRESCRIPTION DRUG Lo Minastrin Fe norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate KIT 20130812 NDA NDA204654 Allergan, Inc. N 20181231 0430-0539_185f3a87-1c64-4025-877d-4f4aad6f774f 0430-0539 HUMAN PRESCRIPTION DRUG norethindrone acetate and ethinyl estradiol and ferrous fumarate norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20160501 NDA NDA204426 Warner Chilcott (US), LLC N 20181231 0430-0540_9144b1b5-34ed-460c-804a-6aeee9f01f2f 0430-0540 HUMAN PRESCRIPTION DRUG Minastrin 24 Fe norethindrone acetate and ethinyl estradiol and ferrous fumarate KIT 20130614 NDA NDA203667 Allergan, Inc. N 20181231 0430-0570_0275b156-948c-418e-8c46-d5f5e69557aa 0430-0570 HUMAN PRESCRIPTION DRUG ESTROSTEP Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20050419 NDA NDA020130 Warner Chilcott (US), LLC E 20171231 0430-0720_8013ad12-2f08-4821-a63c-5d504c624215 0430-0720 HUMAN PRESCRIPTION DRUG Estrace Estradiol TABLET ORAL 20111226 ANDA ANDA040197 Allergan, Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0430-0721_8013ad12-2f08-4821-a63c-5d504c624215 0430-0721 HUMAN PRESCRIPTION DRUG Estrace Estradiol TABLET ORAL 20111226 ANDA ANDA040197 Allergan, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0430-0722_8013ad12-2f08-4821-a63c-5d504c624215 0430-0722 HUMAN PRESCRIPTION DRUG Estrace Estradiol TABLET ORAL 20111226 ANDA ANDA040197 Allergan, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0430-0753_a56e2c5e-ae4a-44a9-a931-7550ec225e09 0430-0753 HUMAN PRESCRIPTION DRUG Delzicol mesalamine CAPSULE, DELAYED RELEASE ORAL 20130301 20180531 NDA NDA204412 Allergan, Inc. MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0430-0783_3712f360-d3ac-407d-85bf-48e0d7f298cf 0430-0783 HUMAN PRESCRIPTION DRUG ASACOL HD mesalamine TABLET, DELAYED RELEASE ORAL 20080528 20190331 NDA NDA021830 Allergan, Inc. MESALAMINE 800 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0430-0979_9fc64dd0-15af-45f8-8fa5-9ac8f37783a4 0430-0979 HUMAN PRESCRIPTION DRUG Atelvia risedronate sodium TABLET, DELAYED RELEASE ORAL 20101201 NDA NDA022560 Warner Chilcott (US), LLC RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 30.1; 4.9 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0430-3100_994e466d-9089-42c8-ad80-c43f6aefa415 0430-3100 HUMAN OTC DRUG Moisturel Dimethicone LOTION TOPICAL 20020822 OTC MONOGRAPH FINAL part347 Allergan, Inc. DIMETHICONE 30 g/g N 20181231 0430-3754_e7f51fb7-04e4-439d-bf5c-e23fc04e4e25 0430-3754 HUMAN PRESCRIPTION DRUG ESTRACE estradiol CREAM VAGINAL 20010701 ANDA ANDA086069 Allergan, Inc. ESTRADIOL .1 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0430-6201_8ec7d3ad-a3fd-452e-a2e5-40666ce5646b 0430-6201 HUMAN PRESCRIPTION DRUG Femring estradiol acetate RING VAGINAL 20030701 NDA NDA021367 Allergan, Inc. ESTRADIOL ACETATE .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0430-6202_8ec7d3ad-a3fd-452e-a2e5-40666ce5646b 0430-6202 HUMAN PRESCRIPTION DRUG Femring estradiol acetate RING VAGINAL 20030701 NDA NDA021367 Allergan, Inc. ESTRADIOL ACETATE .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0436-0669_616a2a4a-195e-48af-a1d9-191826b1d6ca 0436-0669 HUMAN OTC DRUG Di-Dak-Sol Sodium Hypochlorite SOLUTION TOPICAL 20010205 UNAPPROVED DRUG OTHER Century Pharmaceuticals, Inc. SODIUM HYPOCHLORITE .125 mg/mL N 20181231 0436-0672_539dacdb-5ff0-4f52-a89b-4e2e46686339 0436-0672 HUMAN OTC DRUG Dakins Quarter Sodium Hypochlorite SOLUTION TOPICAL 20060524 UNAPPROVED DRUG OTHER Century Pharmaceuticals, Inc. SODIUM HYPOCHLORITE 1.25 mg/mL N 20181231 0436-0936_3324001d-8341-47b0-8e0a-3109c72ecb78 0436-0936 HUMAN OTC DRUG Dakins Half Sodium Hypochlorite SOLUTION TOPICAL 19860609 UNAPPROVED DRUG OTHER Century Pharmaceuticals, Inc. SODIUM HYPOCHLORITE 2.5 mg/mL N 20181231 0436-0946_606e5293-a2f3-48e3-8de4-269f86a72447 0436-0946 HUMAN OTC DRUG Dakins Full Sodium Hypochlorite SOLUTION TOPICAL 19831208 UNAPPROVED DRUG OTHER Century Pharmaceuticals, Inc. SODIUM HYPOCHLORITE 5 mg/mL N 20181231 0440-0124_83f4743b-bae1-458c-aa2d-c1e0d6c511b3 0440-0124 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 Liberty Pharmaceuticals, Inc. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0440-0251_4a41d462-748c-40f1-8fd6-c000959a00cd 0440-0251 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Liberty Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0440-0317_9a555e48-c21e-4bc0-a7c3-ec22b5a40f63 0440-0317 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Liberty Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0440-0318_ff93bbad-2bf6-495e-838c-e0fa3f9b6faa 0440-0318 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Liberty Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0440-1130_c2183561-837b-447a-8f41-8d9ac3457188 0440-1130 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, COATED ORAL 20120418 OTC MONOGRAPH NOT FINAL part343 Liberty Pharmaceuticals, Inc. ASPIRIN 325 ng/1 N 20181231 0440-1185_b93d2bc9-4b61-4b20-a036-0fca0e866e25 0440-1185 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Liberty Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 0440-1243_0ee1d6e4-614a-44d4-9778-03c54a635092 0440-1243 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 Liberty Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0440-1282_e5d17d5a-fa9a-4175-bee8-97060d5338f1 0440-1282 HUMAN PRESCRIPTION DRUG CIMETIDINE CIMETIDINE TABLET ORAL 20101124 ANDA ANDA074890 Liberty Pharmaceuticals, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0440-1350_1ee65ac1-c6be-403f-bd22-0e3d72227937 0440-1350 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19890503 ANDA ANDA071611 Liberty Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0440-1380_b2770457-2c9e-4bf3-8846-96dd44eaa88d 0440-1380 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19710401 ANDA ANDA061454 Liberty Pharmaceuticals, Inc. DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0440-1466_2e3a1562-3641-4281-b681-5a7e9fcaf508 0440-1466 HUMAN OTC DRUG DOK EXTRA STRENGTH STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20020827 OTC MONOGRAPH NOT FINAL part334 Liberty Pharmaceuticals, Inc. DOCUSATE SODIUM 250 mg/1 N 20181231 0440-1481_20f0f4d8-a304-4cf7-af56-b8cd169d2e6f 0440-1481 HUMAN PRESCRIPTION DRUG Doxycyclate Hyclate Doxycycline Hyclate CAPSULE ORAL 19900901 ANDA ANDA062396 Liberty Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0440-1595_d329bf4c-fe7a-4a86-aa7d-f80b29ac5d6f 0440-1595 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20080129 ANDA ANDA040774 Liberty Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0440-1617_5c7814c1-de25-4959-9ac2-6be8c8e5e9c3 0440-1617 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040787 Liberty Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0440-1652_8b106d6e-765c-47b5-8195-1f27ddda49d7 0440-1652 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20130423 NDA NDA018858 Liberty Pharmaceuticals, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0440-1655_fd12cd86-bbb2-4a3d-81e3-6b46e5f11e37 0440-1655 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 Liberty Pharmaceuticals, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 0440-1736_52fa42cf-efc4-4a01-ab61-2376c59799bb 0440-1736 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 Liberty Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 0440-1740_818d8de8-3e05-4714-882a-f68f6fc6e563 0440-1740 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Liberty Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0440-1771_b120cbd9-1ea1-4972-ab81-7c1385c734f2 0440-1771 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Liberty Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0440-1795_fd60fa16-9bd2-4337-b52f-bf71d6e14714 0440-1795 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 Liberty Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0440-1796_fd60fa16-9bd2-4337-b52f-bf71d6e14714 0440-1796 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 Liberty Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0440-1852_8b3464cb-28f6-4c1c-be4a-6e3957c1e44b 0440-1852 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Liberty Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0440-1866_079d1cdd-ac23-48d6-b2ea-e19287ff77fd 0440-1866 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20070308 ANDA ANDA073652 Liberty Pharmaceuticals, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0440-2055_28f9d832-d025-4b3f-8f7e-8248acdbed11 0440-2055 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062936 Liberty Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0440-2070_90c23d3e-e53e-4773-b23c-6e1eef33c73e 0440-2070 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Liberty Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 0440-2300_96b79fbb-56cb-4338-8c37-3150d381782e 0440-2300 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20130715 ANDA ANDA200172 Liberty Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 0440-2406_c552a71f-3a46-4281-a26f-1f503b7c90e2 0440-2406 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Liberty Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0440-5000_a588f193-6be7-4048-bb99-970d8925c760 0440-5000 HUMAN PRESCRIPTION DRUG Alfuzosin hydrochloride Alfuzosin hydrochloride TABLET, EXTENDED RELEASE ORAL 20121002 ANDA ANDA090284 Liberty Pharmaceuticals, Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0440-5195_080af3ed-50a9-4216-9c16-66fc9280a330 0440-5195 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Liberty Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0440-5295_3a9a9dae-0c0a-465f-887a-bd7454e4c79c 0440-5295 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20141112 ANDA ANDA090842 Liberty Pharmaceuticals, Inc. RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0440-5562_29c0c23b-f87d-4a94-a411-4091f399ecd1 0440-5562 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 20121102 ANDA ANDA202764 Liberty Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0440-5563_29c0c23b-f87d-4a94-a411-4091f399ecd1 0440-5563 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 20121102 ANDA ANDA202764 Liberty Pharmaceuticals, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0440-5739_0602af11-dfe8-45b7-991f-5496b08cc0da 0440-5739 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20160331 ANDA ANDA091184 Liberty Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0440-5745_0602af11-dfe8-45b7-991f-5496b08cc0da 0440-5745 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20160331 ANDA ANDA091184 Liberty Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0440-5746_0602af11-dfe8-45b7-991f-5496b08cc0da 0440-5746 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20160331 ANDA ANDA091184 Liberty Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0440-5841_ef53c2fe-295d-48ca-bb35-09349971907d 0440-5841 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20150414 ANDA ANDA077927 Liberty Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0440-5843_19c8dd72-b1a7-45bf-9d92-e756974a7b1c 0440-5843 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20150414 ANDA ANDA078671 Liberty Pharmaceuticals, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0440-5844_19c8dd72-b1a7-45bf-9d92-e756974a7b1c 0440-5844 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20150414 ANDA ANDA078671 Liberty Pharmaceuticals, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0440-6564_76103feb-57d5-4cd1-b6fc-ac8825733909 0440-6564 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120101 ANDA ANDA077911 Liberty Pharmaceuticals, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0440-6565_e1dc8450-aa93-42af-8aba-aa447493bf17 0440-6565 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120101 ANDA ANDA077911 Liberty Pharmaceuticals, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0440-6566_e54a10e9-29e4-4386-9eba-a05559c96bcd 0440-6566 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120101 ANDA ANDA077911 Liberty Pharmaceuticals, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0440-7026_c688f809-80eb-4375-b1d5-1826d83c3c27 0440-7026 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Liberty Pharmaceuticals, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0440-7027_c688f809-80eb-4375-b1d5-1826d83c3c27 0440-7027 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089828 Liberty Pharmaceuticals, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 60; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0440-7033_cdbd882b-80ec-4d72-85b2-835650f08146 0440-7033 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20060313 ANDA ANDA077309 Liberty Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0440-7100_9d821181-fd97-4057-8fca-f7dc12ac89ad 0440-7100 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19880225 ANDA ANDA062884 Liberty Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0440-7128_6bd17203-4f17-48d0-a5c9-b80e0df8cdf5 0440-7128 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Liberty Pharmaceuticals, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0440-7135_184e3741-fc36-42fa-ac4f-05cb36c8e2ed 0440-7135 HUMAN OTC DRUG Adult Low Dose Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20070112 OTC MONOGRAPH FINAL part343 Liberty Pharmaceuticals, Inc. ASPIRIN 81 mg/1 N 20181231 0440-7183_4042eea7-af27-4571-997d-1f0cf5c516a9 0440-7183 HUMAN PRESCRIPTION DRUG Belladonna Alkaloids with Phenobartbital Belladonna Alkaloids with Phenobartbital TABLET ORAL 20001201 UNAPPROVED DRUG OTHER Liberty Pharmaceuticals, Inc. ATROPINE SULFATE; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; PHENOBARBITAL .0194; .1037; .0065; 16.2 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0440-7185_807df50c-c211-475e-9270-b21d4c56df5a 0440-7185 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Liberty Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 0440-7186_807df50c-c211-475e-9270-b21d4c56df5a 0440-7186 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Liberty Pharmaceuticals, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 0440-7200_f8a183f3-d5a0-4d7f-9a81-20f9157db48d 0440-7200 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080312 ANDA ANDA077455 Liberty Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0440-7244_54407902-38cc-4020-bddc-0a67659edc33 0440-7244 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Liberty Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0440-7300_214768a2-e7b6-43b9-9a21-c4168f08eccf 0440-7300 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Liberty Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0440-7350_1324757d-3074-4293-b4b6-1338abaee8ad 0440-7350 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19890503 ANDA ANDA071611 Liberty Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0440-7380_1f007574-56f1-4695-be3a-aeb85c41d466 0440-7380 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 Liberty Pharmaceuticals, Inc. DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0440-7384_6a458cdc-7859-4a91-bb5f-25e7bd91da7a 0440-7384 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 Liberty Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0440-7465_8424afc4-24c5-458f-accc-e2f199a63e3e 0440-7465 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 Liberty Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 0440-7481_64b77fa9-3d66-4be9-a041-9cc0c6cffa09 0440-7481 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840507 ANDA ANDA062396 Liberty Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0440-7482_a26216f9-5683-4404-8e92-9ccacb952695 0440-7482 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19830202 ANDA ANDA062421 Liberty Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0440-7483_a4ba92ff-e219-432b-b118-aba5737ce6b2 0440-7483 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 Liberty Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0440-7559_93784027-63c0-413d-abfc-5c19aa23f06f 0440-7559 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Liberty Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0440-7605_bc3ce0e1-9a5d-42e2-8f7b-1002e8a29a3c 0440-7605 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Liberty Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 0440-7610_87ccd1a9-a92e-4d0d-9088-a011266af1a1 0440-7610 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA089160 Liberty Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 0440-7655_295934bd-dc1c-463b-8daa-f653d6e95174 0440-7655 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19810714 ANDA ANDA087425 Liberty Pharmaceuticals, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 0440-7674_5882cbb4-7d17-4c90-aff3-db64a7831f94 0440-7674 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Liberty Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0440-7805_bfa210b4-ad7a-48c0-9724-ee990117fef4 0440-7805 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Liberty Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0440-7852_89ada3cc-d634-43fd-a873-a912d2c9ecd1 0440-7852 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Liberty Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0440-8055_dcd88916-a5bc-4735-badc-9b0d3cbff2ad 0440-8055 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062936 Liberty Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0440-8056_65771c7d-2af2-40bc-a504-0e4ee8affc07 0440-8056 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 Liberty Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0440-8065_5a4f76e9-f914-4e6f-b218-abf3ab5460c6 0440-8065 HUMAN OTC DRUG UristatUTI Relief Pak UTI Relief Pak Phenazopyridine Hydrochloride TABLET ORAL 20150429 UNAPPROVED DRUG OTHER Liberty Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 0440-8067_da51b9f5-e1c7-4764-adb3-993437cfc8fb 0440-8067 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Liberty Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 0440-8069_da51b9f5-e1c7-4764-adb3-993437cfc8fb 0440-8069 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Liberty Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 0440-8110_e6380429-d874-4ac1-adab-f2c25e94fd66 0440-8110 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Liberty Pharmaceuticals, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0440-8165_79e65904-d281-4e17-9ef2-640b731046a0 0440-8165 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA080356 Liberty Pharmaceuticals, Inc. PREDNISONE 5 mg/1 N 20181231 0440-8167_10fdf7d3-6572-4254-985c-acc1915c9dff 0440-8167 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 Liberty Pharmaceuticals, Inc. PREDNISONE 20 mg/1 N 20181231 0440-8187_98e8b237-6fc9-4206-b648-15d9a3261d86 0440-8187 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET ORAL 20140801 ANDA ANDA204476 Liberty Pharmaceuticals, Inc. PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] N 20181231 0440-8190_dcc3673b-3133-410d-9cac-598f2ba01f43 0440-8190 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 19980301 ANDA ANDA040268 Liberty Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0440-8195_6bf024ef-c46e-4f79-91a3-70f0e2927660 0440-8195 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20120717 ANDA ANDA040712 Liberty Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0440-8300_72a1666b-a50d-4ea5-9492-1b28ecc4bf70 0440-8300 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Liberty Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0440-8305_3410c954-c270-42cc-975d-90d9a0a9e315 0440-8305 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Liberty Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0440-8474_95f07422-9703-4240-8b74-6c1d9429604f 0440-8474 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120628 ANDA ANDA071457 Liberty Pharmaceuticals, Inc. TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0440-8475_95f07422-9703-4240-8b74-6c1d9429604f 0440-8475 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 Liberty Pharmaceuticals, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0440-8476_95f07422-9703-4240-8b74-6c1d9429604f 0440-8476 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 Liberty Pharmaceuticals, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0440-8477_95f07422-9703-4240-8b74-6c1d9429604f 0440-8477 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120628 ANDA ANDA071457 Liberty Pharmaceuticals, Inc. TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0440-8505_6900fe26-43eb-4ef1-ad0b-52eaabee63aa 0440-8505 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20000131 ANDA ANDA060704 Liberty Pharmaceuticals, Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0440-9715_28d23a11-2cd9-4400-a879-5c258f5f7fc6 0440-9715 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20170310 ANDA ANDA207810 Liberty Pharmaceuticals, Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0456-0040_8456e8bf-b833-4c68-ab7a-21685b46c4ab 0456-0040 HUMAN PRESCRIPTION DRUG Thyrolar liothyronine sodium, LEVOTHYROXINE SODIUM TABLET ORAL 19691121 NDA NDA016807 Allergan, Inc. LIOTHYRONINE SODIUM; LEVOTHYROXINE SODIUM 3.1; 12.5 ug/1; ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0456-0045_8456e8bf-b833-4c68-ab7a-21685b46c4ab 0456-0045 HUMAN PRESCRIPTION DRUG Thyrolar liothyronine sodium, LEVOTHYROXINE SODIUM TABLET ORAL 19691121 NDA NDA016807 Allergan, Inc. LIOTHYRONINE SODIUM; LEVOTHYROXINE SODIUM 6.25; 25 ug/1; ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0456-0050_8456e8bf-b833-4c68-ab7a-21685b46c4ab 0456-0050 HUMAN PRESCRIPTION DRUG Thyrolar liothyronine sodium, LEVOTHYROXINE SODIUM TABLET ORAL 19691121 NDA NDA016807 Allergan, Inc. LIOTHYRONINE SODIUM; LEVOTHYROXINE SODIUM 12.5; 50 ug/1; ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0456-0055_8456e8bf-b833-4c68-ab7a-21685b46c4ab 0456-0055 HUMAN PRESCRIPTION DRUG Thyrolar liothyronine sodium, LEVOTHYROXINE SODIUM TABLET ORAL 19691121 NDA NDA016807 Allergan, Inc. LIOTHYRONINE SODIUM; LEVOTHYROXINE SODIUM 25; 100 ug/1; ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0456-0060_8456e8bf-b833-4c68-ab7a-21685b46c4ab 0456-0060 HUMAN PRESCRIPTION DRUG Thyrolar liothyronine sodium, LEVOTHYROXINE SODIUM TABLET ORAL 19691121 NDA NDA016807 Allergan, Inc. LIOTHYRONINE SODIUM; LEVOTHYROXINE SODIUM 37.5; 150 ug/1; ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0456-0400_daab397d-50f1-4633-bdc7-9c46f48132e1 0456-0400 HUMAN PRESCRIPTION DRUG Teflaro ceftaroline fosamil POWDER, FOR SOLUTION INTRAVENOUS 20101029 NDA NDA200327 Allergan, Inc. CEFTAROLINE FOSAMIL 400 mg/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0456-0457_ddab4b01-0e21-4e03-8d18-bac29c8ee12b 0456-0457 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Allergan, Inc. THYROID, PORCINE 15 mg/1 N 20181231 0456-0458_ddab4b01-0e21-4e03-8d18-bac29c8ee12b 0456-0458 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Allergan, Inc. THYROID, PORCINE 30 mg/1 N 20181231 0456-0459_ddab4b01-0e21-4e03-8d18-bac29c8ee12b 0456-0459 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Allergan, Inc. THYROID, PORCINE 60 mg/1 N 20181231 0456-0460_ddab4b01-0e21-4e03-8d18-bac29c8ee12b 0456-0460 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Allergan, Inc. THYROID, PORCINE 90 mg/1 N 20181231 0456-0461_ddab4b01-0e21-4e03-8d18-bac29c8ee12b 0456-0461 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Allergan, Inc. THYROID, PORCINE 120 mg/1 N 20181231 0456-0462_ddab4b01-0e21-4e03-8d18-bac29c8ee12b 0456-0462 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Allergan, Inc. THYROID, PORCINE 180 mg/1 N 20181231 0456-0463_ddab4b01-0e21-4e03-8d18-bac29c8ee12b 0456-0463 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Allergan, Inc. THYROID, PORCINE 240 mg/1 N 20181231 0456-0464_ddab4b01-0e21-4e03-8d18-bac29c8ee12b 0456-0464 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Allergan, Inc. THYROID, PORCINE 300 mg/1 N 20181231 0456-0600_daab397d-50f1-4633-bdc7-9c46f48132e1 0456-0600 HUMAN PRESCRIPTION DRUG Teflaro ceftaroline fosamil POWDER, FOR SOLUTION INTRAVENOUS 20101029 NDA NDA200327 Allergan, Inc. CEFTAROLINE FOSAMIL 600 mg/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0456-1100_f180b475-4aa3-4c3d-965e-c7e2e41ad8bb 0456-1100 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride KIT ORAL 20110429 NDA NDA022567 Allergan, Inc. N 20181231 0456-1101_f180b475-4aa3-4c3d-965e-c7e2e41ad8bb 0456-1101 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride KIT ORAL 20110429 NDA NDA022567 Allergan, Inc. N 20181231 0456-1110_f180b475-4aa3-4c3d-965e-c7e2e41ad8bb 0456-1110 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride TABLET ORAL 20110429 NDA NDA022567 Allergan, Inc. VILAZODONE HYDROCHLORIDE 10 mg/1 N 20181231 0456-1120_f180b475-4aa3-4c3d-965e-c7e2e41ad8bb 0456-1120 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride TABLET ORAL 20110429 NDA NDA022567 Allergan, Inc. VILAZODONE HYDROCHLORIDE 20 mg/1 N 20181231 0456-1140_f180b475-4aa3-4c3d-965e-c7e2e41ad8bb 0456-1140 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride TABLET ORAL 20110429 NDA NDA022567 Allergan, Inc. VILAZODONE HYDROCHLORIDE 40 mg/1 N 20181231 0456-1201_063e5e81-d821-4bc3-853c-95f5dca1546a 0456-1201 HUMAN PRESCRIPTION DRUG Linzess linaclotide CAPSULE, GELATIN COATED ORAL 20120908 NDA NDA202811 Allergan, Inc LINACLOTIDE 145 ug/1 Guanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA] N 20181231 0456-1202_063e5e81-d821-4bc3-853c-95f5dca1546a 0456-1202 HUMAN PRESCRIPTION DRUG Linzess linaclotide CAPSULE, GELATIN COATED ORAL 20120908 NDA NDA202811 Allergan, Inc LINACLOTIDE 290 ug/1 Guanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA] N 20181231 0456-1203_063e5e81-d821-4bc3-853c-95f5dca1546a 0456-1203 HUMAN PRESCRIPTION DRUG Linzess linaclotide CAPSULE, GELATIN COATED ORAL 20170130 NDA NDA202811 Allergan, Inc LINACLOTIDE 72 ug/1 Guanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA] N 20181231 0456-1207_d695cdc0-7d22-4eb1-947e-c7c4005473e7 0456-1207 HUMAN PRESCRIPTION DRUG Namzaric memantine hydrochloride and donepezil hydrochloride CAPSULE ORAL 20160718 NDA NDA206439 Allergan, Inc. MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE 7; 10 mg/1; mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC],Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0456-1214_d695cdc0-7d22-4eb1-947e-c7c4005473e7 0456-1214 HUMAN PRESCRIPTION DRUG Namzaric memantine hydrochloride and donepezil hydrochloride CAPSULE ORAL 20141224 NDA NDA206439 Allergan, Inc. MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE 14; 10 mg/1; mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC],Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0456-1221_d695cdc0-7d22-4eb1-947e-c7c4005473e7 0456-1221 HUMAN PRESCRIPTION DRUG Namzaric memantine hydrochloride and donepezil hydrochloride CAPSULE ORAL 20160718 NDA NDA206439 Allergan, Inc. MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE 21; 10 mg/1; mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC],Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0456-1228_d695cdc0-7d22-4eb1-947e-c7c4005473e7 0456-1228 HUMAN PRESCRIPTION DRUG Namzaric memantine hydrochloride and donepezil hydrochloride CAPSULE ORAL 20141224 NDA NDA206439 Allergan, Inc. MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE 28; 10 mg/1; mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC],Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0456-1229_d695cdc0-7d22-4eb1-947e-c7c4005473e7 0456-1229 HUMAN PRESCRIPTION DRUG Namzaric memantine hydrochloride and donepezil hydrochloride KIT ORAL 20161128 NDA NDA206439 Allergan, Inc. N 20181231 0456-1402_fa7e18d9-6637-4b42-87e0-8ea16c4c67aa 0456-1402 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Allergan USA, Inc. NEBIVOLOL HYDROCHLORIDE 2.5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0456-1405_fa7e18d9-6637-4b42-87e0-8ea16c4c67aa 0456-1405 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Allergan USA, Inc. NEBIVOLOL HYDROCHLORIDE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0456-1410_fa7e18d9-6637-4b42-87e0-8ea16c4c67aa 0456-1410 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Allergan USA, Inc. NEBIVOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0456-1420_fa7e18d9-6637-4b42-87e0-8ea16c4c67aa 0456-1420 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Allergan USA, Inc. NEBIVOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0456-1500_4c015261-22d5-4d64-9c4a-6cfea647f0c1 0456-1500 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride KIT ORAL 20090417 NDA NDA022256 Allergan, Inc. N 20191231 0456-1510_4c015261-22d5-4d64-9c4a-6cfea647f0c1 0456-1510 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Allergan, Inc. MILNACIPRAN HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0456-1512_4c015261-22d5-4d64-9c4a-6cfea647f0c1 0456-1512 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Allergan, Inc. MILNACIPRAN HYDROCHLORIDE 12.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0456-1525_4c015261-22d5-4d64-9c4a-6cfea647f0c1 0456-1525 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Allergan, Inc. MILNACIPRAN HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0456-1550_4c015261-22d5-4d64-9c4a-6cfea647f0c1 0456-1550 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Allergan, Inc. MILNACIPRAN HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0456-2005_34017541-fa92-4f3b-a4db-c8d3de31c5be 0456-2005 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Allergan, Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0456-2010_34017541-fa92-4f3b-a4db-c8d3de31c5be 0456-2010 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Allergan, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0456-2020_34017541-fa92-4f3b-a4db-c8d3de31c5be 0456-2020 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Allergan, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0456-2101_34017541-fa92-4f3b-a4db-c8d3de31c5be 0456-2101 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE SOLUTION ORAL 20021126 NDA NDA021365 Allergan, Inc. ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0456-2202_d31fefb7-725f-4dab-a073-6000a3de5136 0456-2202 HUMAN PRESCRIPTION DRUG Fetzima LEVOMILNACIPRAN HYDROCHLORIDE KIT ORAL 20130725 NDA NDA204168 Allergan USA, Inc. N 20191231 0456-2212_d31fefb7-725f-4dab-a073-6000a3de5136 0456-2212 HUMAN PRESCRIPTION DRUG Fetzima LEVOMILNACIPRAN HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20130725 NDA NDA204168 Allergan USA, Inc. LEVOMILNACIPRAN HYDROCHLORIDE 120 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0456-2220_d31fefb7-725f-4dab-a073-6000a3de5136 0456-2220 HUMAN PRESCRIPTION DRUG Fetzima LEVOMILNACIPRAN HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20130725 NDA NDA204168 Allergan USA, Inc. LEVOMILNACIPRAN HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0456-2240_d31fefb7-725f-4dab-a073-6000a3de5136 0456-2240 HUMAN PRESCRIPTION DRUG Fetzima LEVOMILNACIPRAN HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20130725 NDA NDA204168 Allergan USA, Inc. LEVOMILNACIPRAN HYDROCHLORIDE 40 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0456-2280_d31fefb7-725f-4dab-a073-6000a3de5136 0456-2280 HUMAN PRESCRIPTION DRUG Fetzima LEVOMILNACIPRAN HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20130725 NDA NDA204168 Allergan USA, Inc. LEVOMILNACIPRAN HYDROCHLORIDE 80 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0456-2402_c1f3ccc5-d890-466c-9284-f844947f2e44 0456-2402 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20141230 NDA NDA022117 Allergan USA, Inc. ASENAPINE MALEATE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0456-2405_c1f3ccc5-d890-466c-9284-f844947f2e44 0456-2405 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20130930 NDA NDA022117 Allergan USA, Inc. ASENAPINE MALEATE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0456-2410_c1f3ccc5-d890-466c-9284-f844947f2e44 0456-2410 HUMAN PRESCRIPTION DRUG SAPHRIS Asenapine Maleate TABLET SUBLINGUAL 20130930 NDA NDA022117 Allergan USA, Inc. ASENAPINE MALEATE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 0456-2700_349d9154-9fdb-41d9-a176-ea943c5e3c1c 0456-2700 HUMAN PRESCRIPTION DRUG AVYCAZ ceftazidime, avibactam POWDER, FOR SOLUTION INTRAVENOUS 20141226 NDA NDA206494 Allergan, Inc. CEFTAZIDIME; AVIBACTAM SODIUM 2; .5 g/1; g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 0456-3200_e1b7d73a-c004-4a83-95e3-585806dc1c2c 0456-3200 HUMAN PRESCRIPTION DRUG Namenda Memantine Hydrochloride KIT ORAL 20031016 NDA NDA021487 Allergan, Inc N 20181231 0456-3205_e1b7d73a-c004-4a83-95e3-585806dc1c2c 0456-3205 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20031016 NDA NDA021487 Allergan, Inc MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0456-3210_e1b7d73a-c004-4a83-95e3-585806dc1c2c 0456-3210 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20031016 NDA NDA021487 Allergan, Inc MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0456-3400_a08c165d-3a25-4076-8e1a-bf009512727d 0456-3400 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride KIT ORAL 20110915 NDA NDA022525 Allergan, Inc. N 20181231 0456-3407_a08c165d-3a25-4076-8e1a-bf009512727d 0456-3407 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 NDA NDA022525 Allergan, Inc. MEMANTINE HYDROCHLORIDE 7 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0456-3414_a08c165d-3a25-4076-8e1a-bf009512727d 0456-3414 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 NDA NDA022525 Allergan, Inc. MEMANTINE HYDROCHLORIDE 14 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0456-3421_a08c165d-3a25-4076-8e1a-bf009512727d 0456-3421 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 NDA NDA022525 Allergan, Inc. MEMANTINE HYDROCHLORIDE 21 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0456-3428_a08c165d-3a25-4076-8e1a-bf009512727d 0456-3428 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 NDA NDA022525 Allergan, Inc. MEMANTINE HYDROCHLORIDE 28 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0456-4010_067191ae-0734-4593-8f01-d70a085b9f5b 0456-4010 HUMAN PRESCRIPTION DRUG Celexa citalopram hydrobromide TABLET, FILM COATED ORAL 19980717 NDA NDA020822 Allergan USA, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0456-4020_067191ae-0734-4593-8f01-d70a085b9f5b 0456-4020 HUMAN PRESCRIPTION DRUG Celexa citalopram hydrobromide TABLET, FILM COATED ORAL 19980717 NDA NDA020822 Allergan USA, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0456-4040_067191ae-0734-4593-8f01-d70a085b9f5b 0456-4040 HUMAN PRESCRIPTION DRUG Celexa citalopram hydrobromide TABLET, FILM COATED ORAL 19980717 NDA NDA020822 Allergan USA, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0456-4300_ca71d296-dffe-4ae6-a03c-e28cb9f44094 0456-4300 HUMAN PRESCRIPTION DRUG Monurol Fosfomycin tromethamine POWDER ORAL 19961219 NDA NDA050717 Allergan, Inc. FOSFOMYCIN TROMETHAMINE 3 g/1 N 20181231 0462-0263_fe620bc3-2873-4439-aa92-442fd0313940 0462-0263 HUMAN PRESCRIPTION DRUG Aclovate alclometasone dipropionate CREAM TOPICAL 20090901 ANDA ANDA076973 Pharmaderm, A division of Nycomed US Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g N 20181231 0462-0264_fe620bc3-2873-4439-aa92-442fd0313940 0462-0264 HUMAN PRESCRIPTION DRUG Aclovate alclometasone dipropionate OINTMENT TOPICAL 20091001 ANDA ANDA076884 Pharmaderm, A division of Nycomed US Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g N 20181231 0462-0269_20bdd08b-0d3d-4ad0-8da8-179111d45ecd 0462-0269 HUMAN PRESCRIPTION DRUG Temovate Scalp Application Clobetasol Propionate SOLUTION TOPICAL 19900222 NDA NDA019966 PharmaDerm, A division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0462-0277_c45df254-3691-4e8c-adb6-3bb3c8039472 0462-0277 HUMAN PRESCRIPTION DRUG Clindamax Clindamycin Phosphate CREAM VAGINAL 20091029 ANDA ANDA065139 PHARMADERM. A division of Nycomed US Inc. CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0462-0293_7675b274-767c-48c5-97ef-a53cbd5be28a 0462-0293 HUMAN PRESCRIPTION DRUG Temovate clobetasol propionate GEL TOPICAL 19940429 NDA NDA020337 PharmaDerm, A division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0462-0346_424093cd-d1df-4c1d-ab48-e4305214a65e 0462-0346 HUMAN PRESCRIPTION DRUG Zazole terconazole CREAM VAGINAL 20050218 ANDA ANDA076712 PharmaDerm A division of Fougera Pharmaceuticals Inc. TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0462-0347_f06b64ca-9308-41b5-b164-508e4c94191b 0462-0347 HUMAN PRESCRIPTION DRUG Zazole terconazole CREAM VAGINAL 20091002 NDA NDA021735 Pharmaderm, A division of Nycomed US Inc. TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0462-0348_cfbfbc98-a8e5-42fa-b83f-85719d109aa4 0462-0348 HUMAN PRESCRIPTION DRUG Zazole TERCONAZOLE SUPPOSITORY VAGINAL 20060712 ANDA ANDA076850 PharmaDerm a division of Fougera Pharmaceuticals Inc. TERCONAZOLE 80 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0462-0390_7dad7945-9f1c-46c1-8ecf-1bd81cd918bc 0462-0390 HUMAN PRESCRIPTION DRUG ClindaMax clindamycin phosphate GEL TOPICAL 20091001 ANDA ANDA064160 PharmaDerm, A division of Nycomed US Inc. CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0462-0391_0ebfdc10-471e-41d8-9396-b1e2a0760b7e 0462-0391 HUMAN PRESCRIPTION DRUG ClindaMax Lotion clindamycin phosphate SUSPENSION TOPICAL 20020131 ANDA ANDA065067 PharmaDerm, A division of Nycomed US Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0462-0392_8e63984c-c59a-4c5c-b52f-465fb6e17a67 0462-0392 HUMAN PRESCRIPTION DRUG LoKara desonide LOTION TOPICAL 20020319 ANDA ANDA075860 E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. DESONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0462-0394_e1ccac89-bea8-426a-87f6-164f1046e238 0462-0394 HUMAN PRESCRIPTION DRUG ApexiCon diflorasone diacetate ointment OINTMENT TOPICAL 20090930 ANDA ANDA075374 Pharmaderm, A division of Nycomed US Inc. DIFLORASONE DIACETATE .5 mg/g N 20181231 0462-0434_edc17b37-0b6f-417f-88fd-79f0bbf6c46e 0462-0434 HUMAN PRESCRIPTION DRUG Cutivate fluticasone propionate LOTION TOPICAL 20091005 NDA NDA021152 PharmaDerm, A division of Nycomed US Inc. FLUTICASONE PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0463-1118_dc744432-86ed-48ad-b4a2-3c54a37a1543 0463-1118 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091228 ANDA ANDA090354 C.O. Truxton, Inc. AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 0463-2013_7267994f-589b-407f-ba8b-7971a0d07a58 0463-2013 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130114 ANDA ANDA065103 C.O. Truxton, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0463-6000_e5733d31-1d4a-46b5-9131-4ef99f7b6a84 0463-6000 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20131125 ANDA ANDA062269 C.O. Truxton, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0463-6080_d8b9cc7c-7d73-47ae-868d-436039bb6794 0463-6080 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20100615 ANDA ANDA040644 C.O. Truxton, Inc. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 E 20171231 0463-6141_7f7b221e-0c33-4295-8d8e-cec1cda84c59 0463-6141 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 C.O. Truxton, Inc. PREDNISONE 20 mg/1 E 20171231 0463-6145_ba250e94-ae3b-47ab-bf2e-cf7ea3a47d0a 0463-6145 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER C.O. Truxton, Inc. PHENOBARBITAL 30 mg/1 CIV N 20181231 0463-6151_ba250e94-ae3b-47ab-bf2e-cf7ea3a47d0a 0463-6151 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER C.O. Truxton, Inc. PHENOBARBITAL 60 mg/1 CIV N 20181231 0463-6155_7f7b221e-0c33-4295-8d8e-cec1cda84c59 0463-6155 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 C.O. Truxton, Inc. PREDNISONE 5 mg/1 N 20181231 0463-6160_ba250e94-ae3b-47ab-bf2e-cf7ea3a47d0a 0463-6160 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER C.O. Truxton, Inc. PHENOBARBITAL 15 mg/1 CIV N 20181231 0463-6170_ba250e94-ae3b-47ab-bf2e-cf7ea3a47d0a 0463-6170 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120301 UNAPPROVED DRUG OTHER C.O. Truxton, Inc. PHENOBARBITAL 100 mg/1 CIV N 20181231 0463-6351_b66b20e0-3490-4e85-b626-b5c50d677c8f 0463-6351 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 C.O. Truxton, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0463-6352_b66b20e0-3490-4e85-b626-b5c50d677c8f 0463-6352 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 C.O. Truxton, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0463-6354_b66b20e0-3490-4e85-b626-b5c50d677c8f 0463-6354 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 C.O. Truxton, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0463-7500_cd472295-183d-400a-89eb-77d03c943c94 0463-7500 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20000329 ANDA ANDA089452 C.O. Truxton, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 0463-8000_b06b1320-d88d-4fd3-bf08-613d44d26504 0463-8000 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20000406 ANDA ANDA089452 C.O. Truxton, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 0463-8500_d34a4bba-1c0c-41dc-9c54-36fbb6960339 0463-8500 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20010726 ANDA ANDA089452 C.O. Truxton, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 0469-0125_fe99d292-cd9a-43c9-8d4d-7ded3c461767 0469-0125 HUMAN PRESCRIPTION DRUG Xtandi enzalutamide CAPSULE ORAL 20120831 NDA NDA203415 Astellas Pharma US, Inc. ENZALUTAMIDE 40 mg/1 Androgen Receptor Inhibitor [EPC],Androgen Receptor Antagonists [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0469-0420_f988c363-dca8-4ab7-b675-beae85041472 0469-0420 HUMAN PRESCRIPTION DRUG CRESEMBA isavuconazonium sulfate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150306 NDA NDA207501 Astellas Pharma US, Inc. ISAVUCONAZONIUM SULFATE 74.4 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0469-0520_f988c363-dca8-4ab7-b675-beae85041472 0469-0520 HUMAN PRESCRIPTION DRUG CRESEMBA isavuconazonium sulfate CAPSULE ORAL 20151104 NDA NDA207500 Astellas Pharma US, Inc. ISAVUCONAZONIUM SULFATE 186 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0469-0607_426e5fca-bc45-400f-9d6e-355559f7554e 0469-0607 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus CAPSULE, GELATIN COATED ORAL 19980824 NDA NDA050708 Astellas Pharma US, Inc. TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0469-0617_426e5fca-bc45-400f-9d6e-355559f7554e 0469-0617 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus CAPSULE, GELATIN COATED ORAL 19940408 NDA NDA050708 Astellas Pharma US, Inc. TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0469-0647_0efc0fec-ca65-4b14-ac98-40be39d5ac27 0469-0647 HUMAN PRESCRIPTION DRUG ASTAGRAF XL tacrolimus extended-release capsules CAPSULE, COATED, EXTENDED RELEASE ORAL 20130719 NDA NDA204096 Astellas Pharma US, Inc. TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0469-0657_426e5fca-bc45-400f-9d6e-355559f7554e 0469-0657 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus CAPSULE, GELATIN COATED ORAL 19940408 NDA NDA050708 Astellas Pharma US, Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0469-0677_0efc0fec-ca65-4b14-ac98-40be39d5ac27 0469-0677 HUMAN PRESCRIPTION DRUG ASTAGRAF XL tacrolimus extended-release capsules CAPSULE, COATED, EXTENDED RELEASE ORAL 20130719 NDA NDA204096 Astellas Pharma US, Inc. TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0469-0687_0efc0fec-ca65-4b14-ac98-40be39d5ac27 0469-0687 HUMAN PRESCRIPTION DRUG ASTAGRAF XL tacrolimus extended-release capsules CAPSULE, COATED, EXTENDED RELEASE ORAL 20130719 NDA NDA204096 Astellas Pharma US, Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0469-0871_08f24e07-c578-4b8b-af70-c8a0926ba91c 0469-0871 HUMAN PRESCRIPTION DRUG Adenoscan adenosine SOLUTION INTRAVENOUS 19950518 NDA NDA020059 Astellas Pharma US, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 0469-2601_6f94d8df-e362-49bc-b45e-da23f12f216c 0469-2601 HUMAN PRESCRIPTION DRUG Myrbetriq mirabegron TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120628 NDA NDA202611 Astellas Pharma US, Inc. MIRABEGRON 25 mg/1 beta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0469-2602_6f94d8df-e362-49bc-b45e-da23f12f216c 0469-2602 HUMAN PRESCRIPTION DRUG Myrbetriq mirabegron TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120628 NDA NDA202611 Astellas Pharma US, Inc. MIRABEGRON 50 mg/1 beta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0469-3016_426e5fca-bc45-400f-9d6e-355559f7554e 0469-3016 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus INJECTION, SOLUTION INTRAVENOUS 19940408 NDA NDA050709 Astellas Pharma US, Inc. TACROLIMUS 5 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0469-3051_3ab7fe3b-149e-4ff5-826a-1e23a6d39b55 0469-3051 HUMAN PRESCRIPTION DRUG AmBisome amphotericin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19970811 NDA NDA050740 Astellas Pharma US, Inc. AMPHOTERICIN B 50 mg/12.5mL Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0469-3211_e337975a-4446-437a-b333-470c20e44f1a 0469-3211 HUMAN PRESCRIPTION DRUG Mycamine Micafungin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060627 NDA NDA021506 Astellas Pharma US, Inc. MICAFUNGIN SODIUM 20 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 0469-3211_ee524f16-ce23-454f-8180-722dc2dbd093 0469-3211 HUMAN PRESCRIPTION DRUG Mycamine Micafungin Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141201 NDA NDA021506 Astellas Pharma US, Inc. MICAFUNGIN SODIUM 20 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 0469-3250_e337975a-4446-437a-b333-470c20e44f1a 0469-3250 HUMAN PRESCRIPTION DRUG Mycamine Micafungin sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20050316 NDA NDA021506 Astellas Pharma US, Inc. MICAFUNGIN SODIUM 10 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 0469-3250_ee524f16-ce23-454f-8180-722dc2dbd093 0469-3250 HUMAN PRESCRIPTION DRUG Mycamine Micafungin Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141201 NDA NDA021506 Astellas Pharma US, Inc. MICAFUNGIN SODIUM 10 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 0469-5201_17cc7208-9df0-4f45-921c-54b8c16882d7 0469-5201 HUMAN PRESCRIPTION DRUG Protopic Tacrolimus OINTMENT TOPICAL 20001208 NDA NDA050777 Astellas Pharma US Inc. TACROLIMUS .3 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0469-5202_17cc7208-9df0-4f45-921c-54b8c16882d7 0469-5202 HUMAN PRESCRIPTION DRUG Protopic Tacrolimus OINTMENT TOPICAL 20001208 NDA NDA050777 Astellas Pharma US Inc. TACROLIMUS 1 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0469-6501_c66f773a-3cee-4175-aff5-ad5185641ec3 0469-6501 HUMAN PRESCRIPTION DRUG LEXISCAN regadenoson INJECTION, SOLUTION INTRAVENOUS 20080410 NDA NDA022161 Astellas Pharma US, Inc. REGADENOSON .08 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 0469-8234_c617444d-edaf-4b37-8ea1-de8d411c9f44 0469-8234 HUMAN PRESCRIPTION DRUG Adenocard adenosine SOLUTION INTRAVENOUS 19891030 NDA NDA019937 Astellas Pharma US, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 0472-0013_4dd2648a-15b4-496d-b3b8-e2d9680ae23e 0472-0013 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin SUSPENSION ORAL 20070726 ANDA ANDA065394 Actavis Pharma, Inc. GRISEOFULVIN 125 mg/5mL Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 0472-0066_976b21dd-cbd2-4a9f-95c8-c8c6ee8f9951 0472-0066 HUMAN OTC DRUG Hair Regrowth Treatment minoxidil SOLUTION TOPICAL 19960405 ANDA ANDA074588 Actavis Pharma, Inc. MINOXIDIL 2 g/100mL N 20181231 0472-0082_ff6e3feb-c061-47e4-b8f1-9a89a25adc1b 0472-0082 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir SUSPENSION ORAL 20020903 ANDA ANDA074738 Actavis Pharma, Inc. ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0472-0094_fd2bdfcd-2d7b-4bd8-b6fe-d1591bfa374a 0472-0094 HUMAN OTC DRUG Hair Regrowth Treatment For Men minoxidil SOLUTION TOPICAL 20001120 ANDA ANDA075518 Actavis Pharma, Inc. MINOXIDIL 50 mg/mL N 20181231 0472-0117_3387538d-2517-4a2c-96f5-1344f952dcc2 0472-0117 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 19980420 NDA AUTHORIZED GENERIC NDA020404 Actavis Pharma, Inc. TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0472-0126_289262f9-e6b9-452f-a8cf-2622825d89ef 0472-0126 HUMAN PRESCRIPTION DRUG adapalene adapalene GEL TOPICAL 20141027 ANDA ANDA201000 Actavis Pharma, Inc. ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0472-0150_f7533670-b136-9aea-76ed-d3ac5b5c09ac 0472-0150 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 20150619 ANDA ANDA062367 Actavis Pharma, Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0155_d9f74907-56ac-4fdb-acd4-5ba0a56aac5b 0472-0155 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide OINTMENT TOPICAL 20150605 ANDA ANDA062733 Actavis Pharma, Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0163_f2e76afb-c2e2-4186-afe4-8cd40d53ec0c 0472-0163 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 20100721 ANDA ANDA062949 Actavis Pharma, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0472-0166_441f2c80-8b8f-40b5-b8e2-811bb05fef3e 0472-0166 HUMAN PRESCRIPTION DRUG Nystatin Nystatin OINTMENT TOPICAL 20020903 ANDA ANDA062840 Actavis Pharma, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0472-0179_cbd14924-f4ff-40ea-9f59-779e9c4e5958 0472-0179 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate OINTMENT TOPICAL 19970501 OTC MONOGRAPH FINAL part333B Actavis Pharma, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 0472-0220_1ef0ebef-3226-46aa-9c27-1c04149afd24 0472-0220 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 20030701 ANDA ANDA074165 Actavis Pharma, Inc. CLOTRIMAZOLE 10 mg/g N 20181231 0472-0235_1a3f7194-959d-4ec4-9534-ad92dee83928 0472-0235 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090115 ANDA ANDA078976 Actavis Pharma, Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 0472-0242_a311dfe3-ee03-4163-962f-66e63545afa4 0472-0242 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20041130 ANDA ANDA074806 Actavis Pharma, Inc. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] N 20181231 0472-0310_655b4068-b5a0-4f1c-aa0d-b3ae336e3131 0472-0310 HUMAN PRESCRIPTION DRUG Adapalene and Benzoyl Peroxide Adapalene and Benzoyl Peroxide GEL TOPICAL 20170727 ANDA ANDA203790 Actavis Pharma, Inc. ADAPALENE; BENZOYL PEROXIDE 1; 25 mg/g; mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0472-0321_c7b02f52-625d-4e77-8cc8-c57d52e0a898 0472-0321 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20020103 ANDA ANDA087795 Actavis Pharma, Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0337_7ac46865-5221-40e6-87bb-cb192651619e 0472-0337 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20020930 ANDA ANDA089682 Actavis Pharma, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0339_538686df-9720-48fc-b653-6d97ffbd3832 0472-0339 HUMAN OTC DRUG Hydrocortisone with Aloe Maximum Strength Hydrocortisone CREAM TOPICAL 19970901 OTC MONOGRAPH NOT FINAL part348 Actavis Pharma, Inc. HYDROCORTISONE 1 g/100g N 20181231 0472-0343_d2e7f361-1848-4137-b872-a25d610ec91d 0472-0343 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 19970701 OTC MONOGRAPH NOT FINAL part348 Actavis Pharma, Inc. HYDROCORTISONE 1 g/100g N 20181231 0472-0345_2f8462fe-b250-4d2f-a2af-7d2e2e2bd0e8 0472-0345 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone OINTMENT TOPICAL 19980721 OTC MONOGRAPH NOT FINAL part348 Actavis Pharma, Inc. HYDROCORTISONE 1 g/100g N 20181231 0472-0350_271ea4cf-46c4-434c-a88b-4109f05d7aab 0472-0350 HUMAN OTC DRUG Clotrimazole Antifungal Clotrimazole CREAM TOPICAL 20170103 OTC MONOGRAPH FINAL part333C Actavis Pharma, Inc. CLOTRIMAZOLE 10 mg/g N 20181231 0472-0370_ac3a57d4-d3f8-4dff-8a77-5024436a9df6 0472-0370 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate CREAM TOPICAL 19970901 ANDA ANDA070050 Actavis Pharma, Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0371_ac3a57d4-d3f8-4dff-8a77-5024436a9df6 0472-0371 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate OINTMENT TOPICAL 19971001 ANDA ANDA070051 Actavis Pharma, Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0379_164c81c3-f40f-4c9e-8664-c15865be41cb 0472-0379 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20031216 ANDA ANDA076002 Actavis Pharma, Inc. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0380_2b902b79-df27-43cf-b475-421a533a61cc 0472-0380 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20020903 ANDA ANDA070885 Actavis Pharma, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0381_25180426-b9b7-44fa-b537-7e4057100e63 0472-0381 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 19970201 ANDA ANDA071012 Actavis Pharma, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0382_8253bcc5-6e1f-4c55-88e5-9a60a5d6c686 0472-0382 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT, AUGMENTED TOPICAL 19950901 ANDA ANDA074304 Actavis Pharma, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0400_af78c339-0b78-7520-908b-4448462986c8 0472-0400 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20140203 ANDA ANDA074139 Actavis Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0402_eee4fcb4-6eb0-4f44-996a-e002d7968f91 0472-0402 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SOLUTION TOPICAL 20150529 ANDA ANDA074331 Actavis Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0403_31b9c41b-98cc-497c-b574-72a882d9b836 0472-0403 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SHAMPOO TOPICAL 20120103 ANDA ANDA078854 Actavis Pharma, Inc. CLOBETASOL PROPIONATE .05 g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0404_806b2800-3593-4832-88e7-3c14522e2bcb 0472-0404 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate LOTION TOPICAL 20120102 ANDA ANDA078223 Actavis Pharma, Inc. CLOBETASOL PROPIONATE .05 g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0478_252cb9dd-5b37-4d73-8b77-dab487c88138 0472-0478 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 20160331 ANDA ANDA205082 Actavis Pharma, Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0479_2fb163eb-4db1-491f-91e8-09c3485af7ce 0472-0479 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20161121 ANDA ANDA204965 Actavis Pharma, Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0525_8d91a230-54cd-45a6-9dec-817837050c3e 0472-0525 HUMAN OTC DRUG Anti-Itch Extra Strength Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20170419 OTC MONOGRAPH NOT FINAL part348 Actavis Pharma, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 0472-0527_cf8aab9d-9fd6-4572-869d-b7d16443f7ac 0472-0527 HUMAN OTC DRUG Childrens Allergy Fexofenadine Hydrochloride Fexofenadine Hydrochloride SUSPENSION ORAL 20150105 ANDA ANDA203330 Actavis Pharma, Inc. FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 0472-0730_65f9bf58-ac1e-4f7d-8205-2b6df014003a 0472-0730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 19970401 ANDA ANDA074164 Actavis Pharma, Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 0472-0735_5065cadf-eae6-41c8-8165-26517dd7815f 0472-0735 HUMAN OTC DRUG Antifungal Miconazole Nitrate CREAM TOPICAL 19970601 OTC MONOGRAPH FINAL part333C Actavis Pharma, Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 0472-0803_20fd1c76-feaa-4e56-bbbb-8bb0acc560e2 0472-0803 HUMAN PRESCRIPTION DRUG Desonide desonide LOTION TOPICAL 20090528 ANDA ANDA072354 Actavis Pharma, Inc. DESONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0804_20fd1c76-feaa-4e56-bbbb-8bb0acc560e2 0472-0804 HUMAN PRESCRIPTION DRUG Desonide desonide CREAM TOPICAL 20130801 NDA AUTHORIZED GENERIC NDA019048 Actavis Pharma, Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0825_06c1cc6b-1d47-4c9e-87bf-d990a6eea146 0472-0825 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 20160219 ANDA ANDA074454 Actavis Pharma, Inc. ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0472-0829_3f3100d4-1983-7032-d364-f84ec652c1df 0472-0829 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide SOLUTION TOPICAL 20130512 ANDA ANDA071535 Actavis Pharma, Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0882_57031a0b-801c-4b5c-90ae-adcfe0fcdca0 0472-0882 HUMAN PRESCRIPTION DRUG Acetasol HC Hydrocortisone and Acetic Acid SOLUTION AURICULAR (OTIC) 20020910 ANDA ANDA087143 Actavis Pharma, Inc. HYDROCORTISONE; ACETIC ACID 1.1; 2.41 g/100mL; g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0472-0911_d7b40d68-8679-442f-89fb-b3361b2f094b 0472-0911 HUMAN PRESCRIPTION DRUG Metronidazole Topical Cream, 0.75% Metronidazole Topical Cream, 0.75% CREAM TOPICAL 20090618 NDA NDA020531 Actavis Pharma, Inc METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0472-0987_5c319f58-c163-4649-a406-108847e1ea2f 0472-0987 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin Phosphate SOLUTION TOPICAL 20150115 ANDA ANDA062811 Actavis Pharma, Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 0472-1030_585c10f4-05d7-4eb8-b29f-33d2eb090ed2 0472-1030 HUMAN PRESCRIPTION DRUG Hydromet hydrocodone bitartrate and homatropine methylbromide SOLUTION ORAL 20020930 ANDA ANDA088017 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0472-1105_92caa664-9f47-4230-a84c-462c656d57e4 0472-1105 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 19970601 OTC MONOGRAPH FINAL part333B Actavis Pharma, Inc. BACITRACIN ZINC 500 [USP'U]/g N 20181231 0472-1200_107ec71c-fe08-4ea0-92a7-244b5386b353 0472-1200 HUMAN OTC DRUG FeverALL Infants acetaminophen SUPPOSITORY RECTAL 19800401 NDA NDA018337 Actavis Mid Atlantic LLC ACETAMINOPHEN 80 mg/1 E 20171231 0472-1201_0ed6eb34-ecf3-410e-8bed-1e8def9aff6a 0472-1201 HUMAN OTC DRUG FeverALL Children acetaminophen SUPPOSITORY RECTAL 19800401 NDA NDA018337 Actavis Mid Atlantic LLC ACETAMINOPHEN 120 mg/1 E 20171231 0472-1202_6c35e0be-0e9e-4315-991c-353a41bde71a 0472-1202 HUMAN OTC DRUG FeverALL Junior acetaminophen SUPPOSITORY RECTAL 19800401 NDA NDA018337 Actavis Mid Atlantic LLC ACETAMINOPHEN 325 mg/1 E 20171231 0472-1203_6ba5d432-2db2-47f4-a549-751aa562da09 0472-1203 HUMAN OTC DRUG FeverALL Adults acetaminophen SUPPOSITORY RECTAL 19800401 NDA NDA018337 Actavis Mid Atlantic LLC ACETAMINOPHEN 650 mg/1 E 20171231 0472-1255_5f65b862-72db-4e91-a336-89da0c6c36e0 0472-1255 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 19990430 ANDA ANDA074916 Actavis Pharma, Inc. IBUPROFEN 100 mg/5mL N 20181231 0472-1261_5f65b862-72db-4e91-a336-89da0c6c36e0 0472-1261 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080711 ANDA ANDA074916 Actavis Pharma, Inc. IBUPROFEN 100 mg/5mL N 20181231 0472-1263_5f65b862-72db-4e91-a336-89da0c6c36e0 0472-1263 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080701 ANDA ANDA074916 Actavis Pharma, Inc. IBUPROFEN 100 mg/5mL N 20181231 0472-1270_909ac59c-2991-4a25-9bfe-4c88069f8de6 0472-1270 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 19980327 ANDA ANDA074978 Actavis Pharma, Inc. IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0472-1400_1f18da82-08a9-408e-9ffa-7808b996cffc 0472-1400 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride SYRUP ORAL 20090731 ANDA ANDA040668 Actavis Mid Atlantic LLC CYPROHEPTADINE HYDROCHLORIDE 2 mg/5mL E 20171231 0472-1736_d2069ace-ac8d-4723-8510-d0e1e6fda8a1 0472-1736 HUMAN OTC DRUG Miconazole 7 miconazole nitrate SUPPOSITORY VAGINAL 19970301 ANDA ANDA073507 Actavis Pharma, Inc. MICONAZOLE NITRATE 100 mg/1 N 20181231 0472-1738_153fe6fd-80a8-422c-beb5-376457ffb314 0472-1738 HUMAN PRESCRIPTION DRUG Miconazole Nitrate Miconazole Nitrate SUPPOSITORY VAGINAL 19950118 ANDA ANDA073508 Actavis Pharma, Inc. MICONAZOLE NITRATE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0472-1760_e906e367-7798-44e0-bcd6-7c830eb0ec9a 0472-1760 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20180112 ANDA ANDA074916 Actavis Pharma, Inc. IBUPROFEN 100 mg/5mL N 20191231 0472-1764_e906e367-7798-44e0-bcd6-7c830eb0ec9a 0472-1764 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20160913 ANDA ANDA074916 Actavis Pharma, Inc. IBUPROFEN 100 mg/5mL N 20191231 0472-1783_af0242ab-62b8-4cd5-bdea-5ddf14d4422e 0472-1783 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium GEL TOPICAL 20160519 ANDA ANDA206493 Actavis Pharma, Inc. DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0472-1790_c0688fd4-2d8d-4b5a-ada2-c93edd4bd1bf 0472-1790 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate and Tretinoin Clindamycin Phosphate and Tretinoin GEL TOPICAL 20160705 ANDA ANDA202564 Actavis Pharma, Inc. CLINDAMYCIN PHOSPHATE; TRETINOIN 12; .25 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient],Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0472-1992_9f6f9ced-e617-44d1-9494-16e72f1ca81d 0472-1992 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin SUSPENSION ORAL 20161007 ANDA ANDA205180 Actavis Pharma, Inc. NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0472-3901_08f99b3d-5341-5fe5-0b9b-24f9f46cf366 0472-3901 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140409 ANDA ANDA073085 Actavis Pharma, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0485-0057_9d2f2fbf-0dd3-414f-9747-23dd7e7a7408 0485-0057 HUMAN OTC DRUG ED APAP ACETAMINOPHEN LIQUID ORAL 20120307 OTC MONOGRAPH NOT FINAL part343 EDWARDS PHARMACEUTICALS, INC. ACETAMINOPHEN 160 mg/5mL N 20181231 0485-0080_5649f4a1-21c1-469f-9406-28a843596476 0485-0080 HUMAN OTC DRUG RYMED DEXCHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20111115 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. DEXCHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 10 mg/1; mg/1 N 20181231 0485-0082_61698d95-9cbf-7582-e053-2a91aa0a06a8 0485-0082 HUMAN PRESCRIPTION DRUG ED-SPAZ HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING ORAL 20100512 UNAPPROVED DRUG OTHER EDWARDS PHARMACEUTICALS, INC. HYOSCYAMINE SULFATE .125 mg/1 N 20181231 0485-0094_f10138b7-8948-4e8d-9d83-5eb2ec52fd93 0485-0094 HUMAN OTC DRUG ED CHLORPED CHLORPHENIRAMINE MALEATE LIQUID ORAL 20110428 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. CHLORPHENIRAMINE MALEATE 2 mL/mL N 20181231 0485-0096_be992722-c10f-4c64-9eb0-4c6ab9cb33e6 0485-0096 HUMAN OTC DRUG ED CHLORPED D CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20110601 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/mL; mg/mL N 20181231 0485-0098_8d20e21a-3e3c-4bc5-90b8-bb1e724bd511 0485-0098 HUMAN OTC DRUG ED CHLORPED JR CHLORPHENIRAMINE MALEATE LIQUID ORAL 20110304 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. CHLORPHENIRAMINE MALEATE 2 mg/5mL N 20181231 0485-0151_10109075-6a32-4562-9dc8-c148a61d5d58 0485-0151 HUMAN PRESCRIPTION DRUG UROGESIC BLUE METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, and HYOSCYAMINE SULFATE TABLET, COATED ORAL 20101119 UNAPPROVED DRUG OTHER EDWARDS PHARMACEUTICALS, INC. METHENAMINE; SODIUM PHOSPHATE, MONOBASIC; METHYLENE BLUE; HYOSCYAMINE SULFATE 81.6; 40.8; 10.8; .12 mg/1; mg/1; mg/1; mg/1 Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 0485-0151_5b62621a-a846-4475-bceb-d02bff5632a6 0485-0151 HUMAN PRESCRIPTION DRUG UROGESIC BLUE METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, and HYOSCYAMINE SULFATE TABLET, COATED ORAL 20101119 UNAPPROVED DRUG OTHER EDWARDS PHARMACEUTICALS, INC. METHENAMINE; SODIUM PHOSPHATE, MONOBASIC; METHYLENE BLUE; HYOSCYAMINE SULFATE 81.6; 40.8; 10.8; .12 mg/1; mg/1; mg/1; mg/1 Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 0485-0155_302e2918-16aa-45a1-b87b-2feda0e0297d 0485-0155 HUMAN OTC DRUG ED A-HIST Chlorpheniramine/Phenylephrine LIQUID ORAL 20110111 OTC MONOGRAPH FINAL part341 Edwards Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/5mL; mg/5mL E 20171231 0485-0171_1a30fe48-2898-4051-9341-93170a267371 0485-0171 HUMAN OTC DRUG ED A-HIST DM DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120911 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 15; 4; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 0485-0202_02e9a349-1fc1-4121-a8ea-4b0f8ef8dc78 0485-0202 HUMAN OTC DRUG RYNEX PE BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20110307 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15 mg/5mL; mg/5mL N 20181231 0485-0204_26c24b35-d227-4552-827c-a2ebf71658a3 0485-0204 HUMAN OTC DRUG Rynex DM Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20110314 OTC MONOGRAPH FINAL part341 Edwards Pharmaceuticals, Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 0485-0206_7a2f6dd4-7d1d-4058-a2f0-126327eb557f 0485-0206 HUMAN OTC DRUG RYNEX PSE BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20110307 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15 mg/5mL; mg/5mL N 20181231 0485-0208_fea45bff-6e84-492c-b9f0-eae03248536f 0485-0208 HUMAN OTC DRUG ED BRON GP GUAIFENESIN and PHENYLEPHRINE LIQUID ORAL 20120601 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. GUAIFENESIN; PHENYLEPHRINE 100; 5 mg/5mL; mg/5mL N 20181231 0485-0210_5a2b4ef1-6705-433d-aeb3-6ddd1c204d9c 0485-0210 HUMAN OTC DRUG ED-A-HIST PSE PSEUDOEPHEDRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORIDE TABLET, COATED ORAL 20111008 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 60; 2.5 mg/1; mg/1 N 20181231 0485-0240_0b56f57d-6a1b-4c9a-b28b-0fca8064c739 0485-0240 HUMAN OTC DRUG ED-A-HIST DM CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141027 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 10; 10 mg/1; mg/1; mg/1 N 20181231 0485-0254_f2ad5fe9-9dfc-4cfa-8504-9ecfa39c0ad2 0485-0254 HUMAN OTC DRUG ED A-HIST CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20111008 OTC MONOGRAPH FINAL part341 EDWARDS PHARMACEUTICALS, INC. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 0486-0771_0a8d376c-6ccd-4f17-a291-46d367d8db83 0486-0771 HUMAN PRESCRIPTION DRUG Zamicet HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20150318 ANDA ANDA040834 Pharmaceutical Associates, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0486-1111_1c2ceda2-0bfa-4637-bb0c-1df7609be153 0486-1111 HUMAN PRESCRIPTION DRUG K Phos Original Potassium Phosphate, Monobasic TABLET, SOLUBLE ORAL 19770329 UNAPPROVED DRUG OTHER Beach Products, Inc. POTASSIUM PHOSPHATE, MONOBASIC 500 mg/1 N 20181231 0486-1125_e7ead2c5-afb2-4d45-a4e9-71ba4c25752b 0486-1125 HUMAN PRESCRIPTION DRUG K Phos Neutral Sodium Phosphate, Dibasic, Anhydrous, Potassium Phosphate, Monobasic, and Sodium Phosphate, Monobasic, Monohydrate TABLET, COATED ORAL 19770411 UNAPPROVED DRUG OTHER Beach Productsd, Inc. SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 852; 155; 130 mg/1; mg/1; mg/1 N 20181231 0486-1134_b359f863-2f6e-4884-8714-e34585df1fa1 0486-1134 HUMAN PRESCRIPTION DRUG K-Phos No. 2 Potassium Phosphate, Monobasic and Sodium Phosphate, Monobasic, Anhydrous TABLET, COATED ORAL 19780509 UNAPPROVED DRUG OTHER Beach Products, Inc. POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS 305; 700 mg/1; mg/1 N 20181231 0486-4771_0a8d376c-6ccd-4f17-a291-46d367d8db83 0486-4771 HUMAN PRESCRIPTION DRUG Zamicet HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20150318 ANDA ANDA040834 Pharmaceutical Associates, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 163 mg/7.5mL; mg/7.5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0487-0201_562e30f6-dda6-6165-e054-00144ff88e88 0487-0201 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20071231 ANDA ANDA076749 Nephron SC Inc. IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 3 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0487-0301_f269bd00-7c57-4c03-b5ab-77eb0d9d2d34 0487-0301 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20100331 ANDA ANDA076355 Nephron Pharmaceuticals Corporation ALBUTEROL SULFATE .75 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 0487-2784_53a928ec-1b34-6cf1-e054-00144ff8d46c 0487-2784 HUMAN OTC DRUG Asthmanefrin racepinephrine hydrochloride SOLUTION RESPIRATORY (INHALATION) 20120801 OTC MONOGRAPH FINAL part341 Nephron SC, Inc. RACEPINEPHRINE HYDROCHLORIDE 11.25 mg/.5mL N 20181231 0487-5901_53996ffa-4705-1497-e054-00144ff88e88 0487-5901 HUMAN OTC DRUG S2 racepinephrine hydrochloride SOLUTION RESPIRATORY (INHALATION) 20000101 OTC MONOGRAPH FINAL part341 Nephron SC, Inc. RACEPINEPHRINE HYDROCHLORIDE 11.25 mg/.5mL N 20181231 0487-9301_00451b25-f4c3-4c61-a8ce-bee22074a3bd 0487-9301 HUMAN OTC DRUG Sodium Chloride ISodium Chloride SOLUTION RESPIRATORY (INHALATION) 20020718 UNAPPROVED DRUG OTHER Nephron Pharmaceuticals Corporation SODIUM CHLORIDE .027 mg/3mL E 20171231 0487-9501_5489235a-0640-18ca-e054-00144ff8d46c 0487-9501 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 Nephron SC Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0487-9601_56e01843-e01b-0268-e054-00144ff8d46c 0487-9601 HUMAN PRESCRIPTION DRUG Budesonide BUDESONIDE INHALANT RESPIRATORY (INHALATION) 20131001 ANDA ANDA078202 Nephron SC Inc. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0487-9701_56e01843-e01b-0268-e054-00144ff8d46c 0487-9701 HUMAN PRESCRIPTION DRUG Budesonide BUDESONIDE INHALANT RESPIRATORY (INHALATION) 20131001 ANDA ANDA078202 Nephron SC Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0487-9801_562d5361-1a5e-07e2-e054-00144ff8d46c 0487-9801 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20010927 ANDA ANDA075562 Nephron SC Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0487-9901_562e5b48-d28d-441b-e054-00144ff8d46c 0487-9901 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20010626 ANDA ANDA075664 Nephron SC Inc. ALBUTEROL SULFATE 2.5 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0487-9904_f269bd00-7c57-4c03-b5ab-77eb0d9d2d34 0487-9904 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20040628 ANDA ANDA076355 Nephron Pharmaceuticals Corporation ALBUTEROL SULFATE 1.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 0496-0586_48814a87-ee9c-2e5b-e054-00144ff8d46c 0496-0586 HUMAN OTC DRUG DerMend Moisturizing Anti-Itch pramoxine hydrochloride LOTION TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part348 Ferndale Laboratories, Inc. PRAMOXINE HYDROCHLORIDE 10 mg/mL N 20181231 0496-0741_2b08d90e-47e9-7023-e054-00144ff8d46c 0496-0741 HUMAN OTC DRUG PRAX pramoxine hydrochloride 1% CLOTH TOPICAL 20160201 OTC MONOGRAPH FINAL part346 Ferndale Laboratories, Inc. PRAMOXINE HYDROCHLORIDE 10 mg/g N 20181231 0496-0748_2aa37fc5-2b08-4c13-b473-30d7ffe92fc1 0496-0748 HUMAN OTC DRUG PRAX pramoxine hydrochloride LOTION TOPICAL 20120401 OTC MONOGRAPH FINAL part346 Ferndale Laboratories, Inc. PRAMOXINE HYDROCHLORIDE 10 mg/mL N 20181231 0496-0882_3a0301c3-5f27-4d51-a75b-57fa969f35cf 0496-0882 HUMAN OTC DRUG LMX4 lidocaine CREAM TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part348 Ferndale Laboratories, Inc. LIDOCAINE 40 mg/g N 20181231 0496-0883_4ecf1dbb-8a0f-462b-b50f-767fe1f5ad66 0496-0883 HUMAN OTC DRUG LMX5 lidocaine CREAM TOPICAL 20031001 OTC MONOGRAPH FINAL part346 Ferndale Laboratories, Inc. LIDOCAINE 50 mg/g N 20181231 0496-0892_30ffbbfe-65a5-4129-e054-00144ff8d46c 0496-0892 HUMAN OTC DRUG RECTICARE lidocaine CREAM TOPICAL 20120309 OTC MONOGRAPH FINAL part346 Ferndale Laboratories, Inc. LIDOCAINE 50 mg/g N 20181231 0496-0973_c1739b9d-8680-4f5a-9686-00ba2c7b2ef2 0496-0973 HUMAN OTC DRUG OC8 benzoyl peroxide GEL TOPICAL 20120813 OTC MONOGRAPH NOT FINAL part333D Ferndale Laboratories, Inc. BENZOYL PEROXIDE 7 mg/g N 20181231 0496-0978_2e4387b2-02e4-5543-e054-00144ff8d46c 0496-0978 HUMAN OTC DRUG Recticare Advanced lidocaine and mineral oil and phenylephrine HCl and white petrolatum CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part346 Ferndale Laboratories, Inc. LIDOCAINE; MINERAL OIL; PHENYLEPHRINE HYDROCHLORIDE; PETROLATUM 50; 170; 2.5; 390 mg/g; mg/g; mg/g; mg/g N 20181231 0496-0979_2e432238-1604-4f50-e054-00144ff88e88 0496-0979 HUMAN OTC DRUG RECTICARE ADVANCED glycerin and lidocaine and phenylephrine HCl CLOTH TOPICAL 20160401 OTC MONOGRAPH FINAL part346 Ferndale Laboratories, Inc. GLYCERIN; LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE 200; 50; 2.5 mg/g; mg/g; mg/g N 20181231 0496-0980_2b94136a-496a-2925-e054-00144ff88e88 0496-0980 HUMAN OTC DRUG RECTICARE lidocaine and glycerin CLOTH TOPICAL 20160101 OTC MONOGRAPH FINAL part346 Ferndale Laboratories, Inc. LIDOCAINE; GLYCERIN 50; 200 mg/g; mg/g N 20181231 0496-0985_2e43cdc5-5e78-57ae-e054-00144ff8d46c 0496-0985 HUMAN OTC DRUG RectiCare Complete lidocaine and phenylephrine HCl and glycerin and mineral oil and white petrolatum KIT 20160401 OTC MONOGRAPH FINAL part346 Ferndale Laboratories, Inc. N 20181231 0498-0010_42252bad-05ea-40fe-89c1-66d9aad8ef64 0498-0010 HUMAN OTC DRUG Pyrocaine Burn Benzocaine, Benzethonium Chloride AEROSOL, SPRAY TOPICAL 20130320 OTC MONOGRAPH NOT FINAL part348 North Safety Products BENZOCAINE; BENZETHONIUM CHLORIDE 20; .2 g/100g; g/100g E 20171231 0498-0015_4a402e6c-8fae-479e-962f-6a4922fa2a81 0498-0015 HUMAN OTC DRUG North First Aid Antiseptic Benzalkonium Chloride, Benzocaine SPRAY TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part348 North Safety Products BENZOCAINE; BENZETHONIUM CHLORIDE 10; .2 g/100g; g/100g E 20171231 0498-0016_b73cf3ac-a97a-4cae-b0c5-d84687a8c604 0498-0016 HUMAN OTC DRUG NORTH Antiseptic First Aid benzalkonium chloride and lidocaine SPRAY, METERED TOPICAL 20140429 OTC MONOGRAPH NOT FINAL part348 North Safety Products, LLC. LIDOCAINE; BENZALKONIUM CHLORIDE 1912.5; 107.1 mg/90mL; mg/90mL E 20171231 0498-0020_616cb04a-7c02-c0b9-e053-2a91aa0a2498 0498-0020 HUMAN OTC DRUG North Burn Benzocaine, Benzethonium chloride, Menthol SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 North Safety Products BENZOCAINE; BENZETHONIUM CHLORIDE; MENTHOL 10; .2; .33 g/100g; g/100g; g/100g N 20181231 0498-0030_615cb711-cb19-4bfe-e053-2a91aa0ae7e7 0498-0030 HUMAN OTC DRUG North First Aid Antiseptic Water Soluble Benzethonium chloride, Benzocaine SPRAY TOPICAL 20171223 OTC MONOGRAPH NOT FINAL part333E North Safety Products BENZOCAINE; BENZETHONIUM CHLORIDE 10; .2 g/100g; g/100g N 20181231 0498-0097_394ccab2-8ddf-4248-adda-97a3c676b16d 0498-0097 HUMAN OTC DRUG North Antihistamine DIPHENHYDRAMINE TABLET ORAL 20111202 OTC MONOGRAPH FINAL part341 North Safety Products DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0498-0113_60b6278b-ff08-7716-e053-2a91aa0a103a 0498-0113 HUMAN OTC DRUG North Aspirin Aspirin TABLET ORAL 20111107 OTC MONOGRAPH FINAL part343 North Safety Products ASPIRIN 325 1/1 N 20181231 0498-0118_605279a6-df38-6d7f-e053-2a91aa0a2f70 0498-0118 HUMAN OTC DRUG North PVP Iodine Swabs Povidone-iodine SOLUTION TOPICAL 20120912 UNAPPROVED DRUG OTHER North Safety Products POVIDONE-IODINE .006 g/.6mL N 20181231 0498-0120_6094b9fe-46bd-24f9-e053-2a91aa0acb11 0498-0120 HUMAN OTC DRUG North PVP Iodine Wipe Povidone-iodine 10% SWAB TOPICAL 20171207 UNAPPROVED DRUG OTHER North Safety Products POVIDONE-IODINE 10 mg/mL N 20191231 0498-0140_c18da62e-0dba-4749-9dd7-f0ef20568397 0498-0140 HUMAN OTC DRUG North Alcohol Wipe Isopropyl alcohol SWAB TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part333A North Safety Products ISOPROPYL ALCOHOL .7 mL/mL E 20171231 0498-0141_61040741-c860-1ad5-e053-2991aa0a3ab4 0498-0141 HUMAN OTC DRUG North Alcohol Wipe Isopropyl alcohol SWAB TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part333A North Safety Products ISOPROPYL ALCOHOL .7 mL/mL N 20181231 0498-0142_61040741-c860-1ad5-e053-2991aa0a3ab4 0498-0142 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl alcohol SWAB TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part333A North Safety Products ISOPROPYL ALCOHOL .7 mL/mL N 20181231 0498-0160_d2a4e6e3-5f80-476d-adf1-bdd94ee12dfd 0498-0160 HUMAN OTC DRUG Buffered Eye-Lert Water LIQUID OPHTHALMIC 20100606 OTC MONOGRAPH FINAL part349 North Safety Products WATER 98 mL/100mL E 20171231 0498-0200_6093d88e-179c-6ea8-e053-2a91aa0a0127 0498-0200 HUMAN OTC DRUG North Burn Jel Gel for Burns GEL TOPICAL 20171208 OTC MONOGRAPH NOT FINAL part348 North Safety Products LIDOCAINE HYDROCHLORIDE 2 g/100mL N 20181231 0498-0201_60957f68-e611-ce2d-e053-2a91aa0aac60 0498-0201 HUMAN OTC DRUG North Burn Relief Lidocaine Hydrochloride SPRAY TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 North Safety Products LIDOCAINE HYDROCHLORIDE 24.64 mg/mL N 20181231 0498-0303_609dea2e-592f-c262-e053-2991aa0a2eb3 0498-0303 HUMAN OTC DRUG Miralac CALCIUM CARBONATE TABLET ORAL 20120222 OTC MONOGRAPH FINAL part331 North Safety Products CALCIUM CARBONATE 420 mg/1 N 20181231 0498-0401_6002c37b-74fd-1754-e053-2991aa0af12e 0498-0401 HUMAN OTC DRUG North Antiseptic Benzalkonium chloride SPRAY TOPICAL 20130224 OTC MONOGRAPH NOT FINAL part333E North Safety Products BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 0498-0501_60e6893d-5dd4-a991-e053-2a91aa0ab844 0498-0501 HUMAN OTC DRUG Antiseptic Towelette Benzalkonium chloride LIQUID TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part333E North Safety Products BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 0498-0730_603f76a3-d724-0289-e053-2a91aa0ae599 0498-0730 HUMAN OTC DRUG Neomycin Antibiotic OINTMENT TOPICAL 20100331 OTC MONOGRAPH FINAL part333B North Safety Products NEOMYCIN SULFATE 3.5 mg/g N 20181231 0498-0733_615cf439-1022-2988-e053-2991aa0ab8a6 0498-0733 HUMAN OTC DRUG STING RELIEF PAD ethyl alcohol, lidocaine SWAB TOPICAL 20171223 OTC MONOGRAPH NOT FINAL part348 North Safety Product LLC LIDOCAINE HYDROCHLORIDE; ALCOHOL 20; .5 mg/mL; mL/mL N 20181231 0498-0740_60cee881-41a4-10bb-e053-2a91aa0afce7 0498-0740 HUMAN OTC DRUG North Triple Antibiotic Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate OINTMENT TOPICAL 20130307 OTC MONOGRAPH FINAL part333B North Safety Products BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE 400; 5000; 3.5 [iU]/g; [iU]/g; mg/g N 20181231 0498-0800_6052ce52-a090-6483-e053-2991aa0ae881 0498-0800 HUMAN OTC DRUG HYDROCORTISONE Anti-itch cream OINTMENT TOPICAL 20130306 OTC MONOGRAPH NOT FINAL part348 North Safety Products HYDROCORTISONE ACETATE 1 g/100g N 20181231 0498-0903_60dac908-afd0-5df2-e053-2a91aa0ae14b 0498-0903 HUMAN OTC DRUG First Aid Burn Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20171220 OTC MONOGRAPH NOT FINAL part333A North Safety Products LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE .5; .13 g/100g; g/100g N 20181231 0498-1041_60b6ffdd-f1ac-4654-e053-2991aa0a4360 0498-1041 HUMAN OTC DRUG Sinus Pain Acetaminophen, Phenylephrine HCl TABLET ORAL 20170102 OTC MONOGRAPH FINAL part341 North Safety Products LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 0498-1071_9732d758-679f-43df-848e-d3dd0a617fbb 0498-1071 HUMAN OTC DRUG Antidiarrheal Relief Loperamide HCl TABLET ORAL 20130429 ANDA ANDA074091 North Safety Products LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 0498-1119_60a8def6-96bc-1870-e053-2a91aa0a465d 0498-1119 HUMAN OTC DRUG North Cough Drop Menthol LOZENGE ORAL 20130824 OTC MONOGRAPH FINAL part341 North Safety Products MENTHOL 7 mg/1 N 20181231 0498-1170_6051e2b2-910e-602d-e053-2991aa0af163 0498-1170 HUMAN OTC DRUG Multi Symptom Cold Acetaminophen, Dextromethorphan, Phenylephrine, Guaifenesin TABLET ORAL 20170102 OTC MONOGRAPH NOT FINAL part343 North Safety Products LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 325; 162; 200; 15 mg/1; mg/1; mg/1; mg/1 N 20181231 0498-1733_615cf439-1022-2988-e053-2991aa0ab8a6 0498-1733 HUMAN OTC DRUG Nox-A-Sting ethyl alcohol, lidocaine SWAB TOPICAL 20171223 OTC MONOGRAPH NOT FINAL part348 North Safety Product LLC LIDOCAINE HYDROCHLORIDE; ALCOHOL 20; .5 mg/mL; mL/mL N 20181231 0498-2001_6053375b-d719-5eed-e053-2a91aa0a849c 0498-2001 HUMAN OTC DRUG Aypanal Non-Aspirin acetaminophen TABLET ORAL 20170102 OTC MONOGRAPH NOT FINAL part343 North Safety Products ACETAMINOPHEN 325 mg/1 N 20181231 0498-2102_615d3955-988a-fb03-e053-2991aa0a0785 0498-2102 HUMAN OTC DRUG BACK RELIEF ACETAMINOPHEN, MAGNESIUM SALICYLATE TABLET ORAL 20171220 OTC MONOGRAPH NOT FINAL part343 North Safety Products LLC ACETAMINOPHEN; MAGNESIUM SALICYLATE 200; 200 mg/1; mg/1 N 20181231 0498-2110_60b6b384-e450-bd8c-e053-2991aa0a0c92 0498-2110 HUMAN OTC DRUG Aypanal EX Acetaminophen TABLET ORAL 20170102 OTC MONOGRAPH NOT FINAL part343 North Safety Products ACETAMINOPHEN 500 mg/1 N 20181231 0498-2422_60b6b7a7-2e93-a6da-e053-2a91aa0a792e 0498-2422 HUMAN OTC DRUG Pain Stoppers Acetaminophen, Caffeine, Aspirin, Salicylamide TABLET ORAL 20170102 OTC MONOGRAPH NOT FINAL part343 North Safety Products LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE; SALICYLAMIDE 110; 162; 32.4; 152 mg/1; mg/1; mg/1; mg/1 N 20181231 0498-2521_60d03412-336b-668b-e053-2a91aa0aafaf 0498-2521 HUMAN OTC DRUG Pain Stoppers EX Acetaminophen, Caffeine, Aspirin TABLET, COATED ORAL 20170102 OTC MONOGRAPH NOT FINAL part343 North Safety Products LLC ACETAMINOPHEN; CAFFEINE; ASPIRIN 250; 65; 250 mg/1; mg/1; mg/1 N 20181231 0498-3111_60dc17a2-afd8-2d5f-e053-2a91aa0a3cf5 0498-3111 HUMAN OTC DRUG PAWS Ethyl alcohol LIQUID TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part333E North Safety Products ALCOHOL 665 mL/L N 20181231 0498-3330_60b670bc-bed4-53ff-e053-2a91aa0a3d1d 0498-3330 HUMAN OTC DRUG North Sinus Decongestant Phenylephrine TABLET ORAL 20120610 OTC MONOGRAPH FINAL part341 North Safety Products LLC PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 N 20181231 0498-3333_609dfffe-ee0c-c218-e053-2a91aa0ace1c 0498-3333 HUMAN OTC DRUG North Ammonia Inhalent Ammonia Inhalent INHALANT RESPIRATORY (INHALATION) 20171208 UNAPPROVED DRUG OTHER North Safety Products AMMONIA .045 g/.3mL N 20181231 0498-7001_60b3caaa-e6c7-515e-e053-2a91aa0aa671 0498-7001 HUMAN OTC DRUG Fem Relief Acetaminophen Pamabrom TABLET ORAL 20170101 OTC MONOGRAPH NOT FINAL part343 North Safety Products LLC ACETAMINOPHEN; PAMABROM 325; 25 mg/1; mg/1 N 20181231 0498-7501_609d7158-042d-0dca-e053-2a91aa0aa8bf 0498-7501 HUMAN OTC DRUG Cedaprin Ibuprofen TABLET ORAL 20170102 ANDA ANDA079129 North Safety Products LLC IBUPROFEN 200 mg/1 N 20181231 0498-8035_5b4a841e-f63f-bd52-e053-2a91aa0afcee 0498-8035 HUMAN OTC DRUG North Safety First Aid Kit 553001 Ethyl Alcohol KIT TOPICAL 20080922 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8036_5b5da3d4-8401-8632-e053-2a91aa0aa23f 0498-8036 HUMAN OTC DRUG North Safety First Aid Kit 35P10BBK Benzalkonium Chloride, Ethyl Alcohol KIT TOPICAL 20080922 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8037_5b60aec8-82a3-b5e0-e053-2a91aa0a3b61 0498-8037 HUMAN OTC DRUG North Safety First Aid Kit Z63157978 Ethyl Alcohol KIT TOPICAL 20110301 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8039_59b557cf-4292-a59f-e053-2991aa0ae663 0498-8039 HUMAN OTC DRUG North Safety First Aid Kit Z63158027 Ethyl Alcohol KIT TOPICAL 20110301 OTC MONOGRAPH NOT FINAL 333E North Safety Products LLC N 20181231 0498-8040_5b6075d4-fb21-c398-e053-2991aa0ad747 0498-8040 HUMAN OTC DRUG North Safety First Aid Kit SF00003588 Ethyl Alcohol KIT TOPICAL 20131119 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8041_5b603459-63e8-207f-e053-2991aa0ac729 0498-8041 HUMAN OTC DRUG North Safety First Aid Kit 554001 Ethyl Alcohol KIT TOPICAL 20080922 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8042_5b3b70ca-9c07-4f4a-e053-2991aa0a42b8 0498-8042 HUMAN OTC DRUG North Safety First Aid Kit 019746-0032L Benzalkonium Chloride KIT TOPICAL 20040401 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8043_5b3518c6-f389-4814-e053-2991aa0a2bfb 0498-8043 HUMAN OTC DRUG North Safety First Aid Kit 019740-0027L/Z019740-0027L Benzalkonium Chloride KIT TOPICAL 20040401 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8044_5b71f459-2608-7b6b-e053-2a91aa0afda6 0498-8044 HUMAN OTC DRUG North Safety First Aid Kit Z42750 Ethyl Alcohol KIT TOPICAL 20090312 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8046_5b3b5b14-5efd-e594-e053-2a91aa0ab66d 0498-8046 HUMAN OTC DRUG North Safety First Aid Kit 019740-4526 Benzalkonium Chloride KIT TOPICAL 20040713 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8047_5b3b5b14-5f15-e594-e053-2a91aa0ab66d 0498-8047 HUMAN OTC DRUG North Safety First Aid Kit SF00002054 Benzalkonium Chloride KIT TOPICAL 20101015 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8048_5b3b5b14-5f16-e594-e053-2a91aa0ab66d 0498-8048 HUMAN OTC DRUG North Safety First Aid Kit 019745-0032L Benzalkonium Chloride KIT TOPICAL 20040401 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8051_5b46a32d-f060-5d78-e053-2991aa0a7c84 0498-8051 HUMAN OTC DRUG North Safety First Aid Kit Z130023L Benzalkonium Chloride KIT TOPICAL 20060619 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8053_5bfd6377-a66d-2e04-e053-2991aa0a9ceb 0498-8053 HUMAN OTC DRUG North Safety First Aid Kit Z019846 Benzalkonium Chloride KIT TOPICAL 20130326 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8054_59a0c339-2613-7941-e053-2a91aa0ad5f1 0498-8054 HUMAN OTC DRUG North Safety First Aid Kit SF00004415 Benzalkonium Chloride KIT TOPICAL 20161101 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8055_593d673d-5e1d-2756-e053-2a91aa0a31e6 0498-8055 HUMAN OTC DRUG North Safety First Aid Kit 685533T13 Benzalkonium chloride, Water, Ammonia KIT OPHTHALMIC; RESPIRATORY (INHALATION); TOPICAL 20080922 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8056_5b71ddd8-2084-68c1-e053-2a91aa0a314f 0498-8056 HUMAN OTC DRUG North Safety First Aid Kit Z42500MG Ethyl Alcohol KIT TOPICAL 20130621 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8057_5b720973-1e0b-2409-e053-2a91aa0a01f8 0498-8057 HUMAN OTC DRUG North Safety First Aid Kit Z019814 Ethyl Alcohol KIT TOPICAL 20121212 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8059_5b72357e-6c83-99f6-e053-2991aa0aab9c 0498-8059 HUMAN OTC DRUG North Safety First Aid Kit 68G100 Ethyl Alcohol KIT TOPICAL 20080922 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8060_5b72357e-6cf7-99f6-e053-2991aa0aab9c 0498-8060 HUMAN OTC DRUG North Safety First Aid Kit Z130023S Benzalkonium Chloride KIT TOPICAL 20060619 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8061_5bec8bc8-6469-3fa1-e053-2991aa0a633d 0498-8061 HUMAN OTC DRUG North Safety First Aid Kit SF00000669 Ethyl Alcohol, Benzalkonium Chloride KIT TOPICAL 20090731 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-8062_5bfca527-6f2a-df82-e053-2a91aa0a8202 0498-8062 HUMAN OTC DRUG North Safety First Aid Kit SF00003284 Benzalkonium Chloride KIT TOPICAL 20130405 UNAPPROVED DRUG OTHER North Safety Products LLC N 20181231 0498-9000_61057c72-0928-7dff-e053-2a91aa0aac0b 0498-9000 HUMAN OTC DRUG Rescue Breather Kit isopropyl alcohol KIT TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part333A North Safety Products N 20181231 0498-9001_615cebfa-ae4d-346b-e053-2a91aa0af564 0498-9001 HUMAN OTC DRUG Biohazard Bag, Antiseptic Towelettes and Towels Benzalkonium chloride KIT TOPICAL 20171222 OTC MONOGRAPH NOT FINAL part333E North Safety Products N 20181231 0498-9002_61e1497d-40f2-0c87-e053-2991aa0a2943 0498-9002 HUMAN OTC DRUG Splinter First Aid Kit Povidone iodine, KIT TOPICAL 20171229 UNAPPROVED DRUG OTHER North Safety Products N 20191231 0517-0020_f5f24c21-235b-4346-a08c-aa68238a109d 0517-0020 HUMAN PRESCRIPTION DRUG Caffeine Citrate Caffeine Citrate INJECTION, SOLUTION INTRAVENOUS 20070910 ANDA ANDA077906 American Regent, Inc. CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0517-0031_05386eaa-75b6-44a2-afb6-4fe04e38e67a 0517-0031 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR 19900930 ANDA ANDA080737 American Regent, Inc. CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 0517-0032_05386eaa-75b6-44a2-afb6-4fe04e38e67a 0517-0032 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR 19961107 ANDA ANDA080737 American Regent, Inc. CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 0517-0130_05386eaa-75b6-44a2-afb6-4fe04e38e67a 0517-0130 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR 20030529 ANDA ANDA080737 American Regent, Inc. CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 0517-0134_af01fdb8-d3d7-4186-a58f-f58839f1ceb8 0517-0134 HUMAN PRESCRIPTION DRUG Dexferrum iron dextran INJECTION, SOLUTION INTRAVENOUS 19981001 NDA NDA040024 American Regent, Inc. IRON DEXTRAN 50 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0517-0234_af01fdb8-d3d7-4186-a58f-f58839f1ceb8 0517-0234 HUMAN PRESCRIPTION DRUG Dexferrum iron dextran INJECTION, SOLUTION INTRAVENOUS 19960301 NDA NDA040024 American Regent, Inc. IRON DEXTRAN 50 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0517-0374_60f0632c-ab45-c3c3-e053-2a91aa0a5f81 0517-0374 HUMAN PRESCRIPTION DRUG PROVAYBLUE methylene blue INJECTION INTRAVENOUS 20160408 NDA NDA204630 American Regent, Inc. METHYLENE BLUE 5 mg/mL Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 0517-0375_9b1f07e8-9cc5-4c8e-9a9c-d6f4670dbf42 0517-0375 HUMAN PRESCRIPTION DRUG Indigo Carmine Indigo Carmine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. INDIGOTINDISULFONATE SODIUM 8 mg/mL N 20181231 0517-0401_8d37f8e3-26c6-4500-8360-f1f4b146c0a3 0517-0401 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19921101 UNAPPROVED DRUG OTHER American Regent, Inc. ATROPINE SULFATE .4 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0517-0601_75dc1361-b8f8-44ac-980d-47c08d7307cf 0517-0601 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080530 ANDA ANDA078145 American Regent, Inc. KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0517-0650_33fd0936-5b19-4cc5-bb74-a2789a8cfb88 0517-0650 HUMAN PRESCRIPTION DRUG Injectafer Ferric Carboxymaltose Injection INJECTION, SOLUTION INTRAVENOUS 20130812 NDA NDA203565 American Regent, Inc. FERRIC CARBOXYMALTOSE 50 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0517-0720_0deadaca-96c5-4759-ae1f-d76b44120507 0517-0720 HUMAN PRESCRIPTION DRUG Betamethasone Sodium Phosphate and Betamethasone Acetate Betamethasone Sodium Phosphate and Betamethasone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR 20100428 ANDA ANDA090747 American Regent, Inc. BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0517-0725_c6e9adac-87ad-4916-ade6-bc8e26c9144a 0517-0725 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Buprenorphine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100813 ANDA ANDA078331 American Regent, Inc. BUPRENORPHINE HYDROCHLORIDE .324 mg/mL Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 0517-0730_bfdf5529-ee6b-4d6a-b1c7-e5b2b3827579 0517-0730 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride INJECTION, SOLUTION EPIDURAL 20100415 ANDA ANDA091104 American Regent, Inc. CLONIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0517-0731_bfdf5529-ee6b-4d6a-b1c7-e5b2b3827579 0517-0731 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride INJECTION, SOLUTION EPIDURAL 20100415 ANDA ANDA091104 American Regent, Inc. CLONIDINE HYDROCHLORIDE 500 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0517-0735_32b24699-3461-4e45-9567-7eb856aff5dc 0517-0735 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 20091117 ANDA ANDA090534 American Regent, Inc. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0517-0740_f7ab2221-907c-44cc-ba69-5e3528a18de0 0517-0740 HUMAN PRESCRIPTION DRUG Methylergonovine Maleate Methylergonovine Maleate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100621 ANDA ANDA090193 American Regent, Inc. METHYLERGONOVINE MALEATE .2 mg/mL Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 0517-0745_dad40790-a202-4522-bda4-49195ef86bca 0517-0745 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20100716 ANDA ANDA078942 American Regent, Inc. PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0517-0746_dad40790-a202-4522-bda4-49195ef86bca 0517-0746 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20100809 ANDA ANDA078942 American Regent, Inc. PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0517-0750_67cbd1da-38b6-498e-a721-6fb2f4528a68 0517-0750 HUMAN PRESCRIPTION DRUG Progesterone Progesterone INJECTION, SOLUTION INTRAMUSCULAR 20100929 ANDA ANDA090845 American Regent, Inc. PROGESTERONE 50 mg/mL Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 0517-0760_e4abdf47-d651-478c-be0b-88b2f256023c 0517-0760 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20100701 ANDA ANDA076830 American Regent, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 0517-0770_a6fcba37-f7d9-4d9e-bf45-c8f7af4261e3 0517-0770 HUMAN PRESCRIPTION DRUG Torsemide Torsemide INJECTION, SOLUTION INTRAVENOUS 20100521 ANDA ANDA090656 American Regent, Inc. TORSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0517-0771_a6fcba37-f7d9-4d9e-bf45-c8f7af4261e3 0517-0771 HUMAN PRESCRIPTION DRUG Torsemide Torsemide INJECTION, SOLUTION INTRAVENOUS 20100526 ANDA ANDA090656 American Regent, Inc. TORSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0517-0780_6229ff97-532b-4c62-9d19-ed22c952f5f8 0517-0780 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20100630 ANDA ANDA078867 American Regent, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 0517-0781_6229ff97-532b-4c62-9d19-ed22c952f5f8 0517-0781 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20100630 ANDA ANDA078867 American Regent, Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 0517-0785_38afd657-1aed-43d6-aad3-9e75fc025e57 0517-0785 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110204 ANDA ANDA091152 American Regent, Inc. BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 0517-0790_a5bf7ff6-bba0-4e86-92d1-9f929fd4794b 0517-0790 HUMAN PRESCRIPTION DRUG Nandrolone Decanoate Nandrolone Decanoate INJECTION, SOLUTION INTRAMUSCULAR 20000101 ANDA ANDA091252 American Regent, Inc. NANDROLONE DECANOATE 200 mg/mL Androgen [EPC] CIII E 20171231 0517-0801_75dc1361-b8f8-44ac-980d-47c08d7307cf 0517-0801 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080530 ANDA ANDA078145 American Regent, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0517-0830_2db770c5-97b0-40dd-a442-d4d1be4f5df9 0517-0830 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION OPHTHALMIC 20110802 ANDA ANDA200925 American Regent, Inc. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 0517-0901_2e4ecf15-03d9-4e8c-9826-e5392cea3e10 0517-0901 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970630 ANDA ANDA040136 American Regent, Inc. HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 0517-0902_75dc1361-b8f8-44ac-980d-47c08d7307cf 0517-0902 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20080530 ANDA ANDA078145 American Regent, Inc. KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0517-0920_a4944e7c-0a07-4788-943a-6972a960a5d3 0517-0920 HUMAN PRESCRIPTION DRUG N/A busulfan INJECTION INTRAVENOUS 20170401 ANDA ANDA202259 American Regent, Inc. BUSULFAN 6 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0517-0955_8f786cd4-0d03-4184-be04-2934aeb02c21 0517-0955 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20120627 ANDA ANDA201741 American Regent, Inc. OLANZAPINE 10 mg/2mL Atypical Antipsychotic [EPC] N 20181231 0517-0960_bc5f76e7-15df-4516-a314-9c9c524a19ea 0517-0960 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20111115 ANDA ANDA201885 American Regent, Inc. TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 0517-1010_8d37f8e3-26c6-4500-8360-f1f4b146c0a3 0517-1010 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19921201 UNAPPROVED DRUG OTHER American Regent, Inc. ATROPINE SULFATE 1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0517-1045_404f8751-8303-4169-9eaf-63bde3f356b0 0517-1045 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine INJECTION, SOLUTION INTRAVENOUS 20011008 ANDA ANDA075861 American Regent, Inc. LEVOCARNITINE 200 mg/mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] N 20181231 0517-1071_68b1bf4a-ca90-47f6-99b8-939e75f14601 0517-1071 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 0517-1130_9c0aad7a-46d5-4185-bfbd-ec11897d4bd8 0517-1130 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19940301 UNAPPROVED DRUG OTHER American Regent, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 0517-1305_4e31c773-2498-4e91-b270-3dd8b13da21b 0517-1305 HUMAN PRESCRIPTION DRUG Dopamine HCl Dopamine HCl INJECTION, SOLUTION INTRAVENOUS 19900930 ANDA ANDA070826 American Regent, Inc. DOPAMINE HYDROCHLORIDE 160 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0517-1805_4e31c773-2498-4e91-b270-3dd8b13da21b 0517-1805 HUMAN PRESCRIPTION DRUG Dopamine HCl Dopamine HCl INJECTION, SOLUTION INTRAVENOUS 19900930 ANDA ANDA070799 American Regent, Inc. DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0517-1810_d8a28019-3c7c-4b60-9f6e-a667fb543abc 0517-1810 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20160101 ANDA ANDA201126 American Regent, Inc. ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0517-1820_614c7c90-6d95-436f-ac98-0281f03f01ff 0517-1820 HUMAN PRESCRIPTION DRUG Chlorothiazide Sodium Chlorothiazide Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150401 ANDA ANDA202561 American Regent, Inc. CHLOROTHIAZIDE SODIUM 500 mg/18mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0517-1825_212cd91b-43b6-438a-817c-ae189dead6d9 0517-1825 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol INJECTION INTRAMUSCULAR; INTRAVENOUS 20180115 ANDA ANDA207496 American Regent, Inc. METHOCARBAMOL 100 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0517-1905_4e31c773-2498-4e91-b270-3dd8b13da21b 0517-1905 HUMAN PRESCRIPTION DRUG Dopamine HCl Dopamine HCl INJECTION, SOLUTION INTRAVENOUS 19900930 ANDA ANDA070820 American Regent, Inc. DOPAMINE HYDROCHLORIDE 80 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0517-1980_bdb8f297-a67f-4e0e-afc5-ce18f2ec9896 0517-1980 HUMAN PRESCRIPTION DRUG Dicyclomine hydrochloride Dicyclomine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 20170901 ANDA ANDA208353 American Regent, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/2mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0517-2310_cfd3d692-06bb-4ab4-b2c5-374e9d5ed2ba 0517-2310 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20070612 NDA NDA021135 American Regent, Inc. IRON SUCROSE 20 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0517-2325_cfd3d692-06bb-4ab4-b2c5-374e9d5ed2ba 0517-2325 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20110127 NDA NDA021135 American Regent, Inc. IRON SUCROSE 20 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0517-2340_cfd3d692-06bb-4ab4-b2c5-374e9d5ed2ba 0517-2340 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20001110 NDA NDA021135 American Regent, Inc. IRON SUCROSE 20 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0517-2502_cc74fb4c-d783-43a8-8151-925d9a40524b 0517-2502 HUMAN PRESCRIPTION DRUG Caffeine and Sodium Benzoate Caffeine and Sodium Benzoate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19930201 UNAPPROVED DRUG OTHER American Regent, Inc. CAFFEINE 125 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 0517-2710_e989de82-5b4a-4342-8af9-011a86cdfd7c 0517-2710 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION, SOLUTION INTRAVENOUS 20170705 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE American Regent, Inc. CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0517-2810_0859ec99-9f2f-4523-9c03-2655e8517abd 0517-2810 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0517-3005_612d00c0-cf9f-4254-8f3e-84550222e11d 0517-3005 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. WATER 1 mL/mL N 20181231 0517-3120_551b56da-71af-4777-8a2b-3bfd7a391f1b 0517-3120 HUMAN PRESCRIPTION DRUG Nutrilyte Multi-Electrolyte INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLUCONATE; MAGNESIUM ACETATE; POTASSIUM ACETATE; CALCIUM ACETATE 135; 125; 55; 43; 34.5; 22 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0517-3605_851d4b5a-6477-4af3-9cb6-ada4b9335b40 0517-3605 HUMAN PRESCRIPTION DRUG levetiracetam levetiracetam INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20120221 ANDA ANDA202143 American Regent, Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0517-3900_5178d569-7ff6-46de-a8ce-498e9608ef3f 0517-3900 HUMAN PRESCRIPTION DRUG Calcium Gluconate Calcium Gluconate INJECTION, SOLUTION INTRAVENOUS 19921201 UNAPPROVED DRUG OTHER American Regent, Inc. CALCIUM GLUCONATE MONOHYDRATE 98 mg/mL Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] E 20171231 0517-3950_5178d569-7ff6-46de-a8ce-498e9608ef3f 0517-3950 HUMAN PRESCRIPTION DRUG Calcium Gluconate Calcium Gluconate INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. CALCIUM GLUCONATE MONOHYDRATE 98 mg/mL Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] E 20171231 0517-4002_9ec8ef2a-4468-4e2a-bcbd-c6e943a9c7ae 0517-4002 HUMAN PRESCRIPTION DRUG Papaverine Hydrochloride Papaverine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19950901 UNAPPROVED DRUG OTHER American Regent, Inc. PAPAVERINE HYDROCHLORIDE 30 mg/mL N 20181231 0517-4050_560eaf50-0d23-4df6-9068-eebba66634d4 0517-4050 HUMAN PRESCRIPTION DRUG Mannitol mannitol INJECTION, SOLUTION INTRAVENOUS 19900930 ANDA ANDA087409 American Regent, Inc. MANNITOL 250 mg/mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] E 20171231 0517-4201_68339db9-39d6-4dec-bc8b-0db49cf22223 0517-4201 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 19900930 ANDA ANDA087408 American Regent, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20191231 0517-4601_81a62644-6090-48ee-b6b1-391c9525a10e 0517-4601 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 ANDA ANDA089335 American Regent, Inc. GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0517-4602_81a62644-6090-48ee-b6b1-391c9525a10e 0517-4602 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 ANDA ANDA089335 American Regent, Inc. GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0517-4605_81a62644-6090-48ee-b6b1-391c9525a10e 0517-4605 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 ANDA ANDA089335 American Regent, Inc. GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0517-4620_81a62644-6090-48ee-b6b1-391c9525a10e 0517-4620 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 ANDA ANDA089335 American Regent, Inc. GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0517-4810_49464440-b35f-429f-a97e-90230af9ee10 0517-4810 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin INJECTION, SOLUTION INTRAVENOUS 20030304 ANDA ANDA072034 American Regent, Inc. NITROGLYCERIN 5 mg/mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0517-5023_0954629f-ef6f-42d1-b3c9-409597fb8a24 0517-5023 HUMAN PRESCRIPTION DRUG Sodum Acetate Sodium Acetate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. SODIUM ACETATE ANHYDROUS 328 mg/mL N 20181231 0517-5601_68339db9-39d6-4dec-bc8b-0db49cf22223 0517-5601 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 19900930 ANDA ANDA087408 American Regent, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20191231 0517-5602_68339db9-39d6-4dec-bc8b-0db49cf22223 0517-5602 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 19900930 ANDA ANDA087408 American Regent, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20191231 0517-6110_aa7dac70-f497-4191-b52a-a96cf25872a8 0517-6110 HUMAN PRESCRIPTION DRUG Zinc Sulfate Zinc Sulfate INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE ANHYDROUS 1 mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 0517-6202_c8aa6a43-0e1f-43e5-a042-e3b3a3e931dd 0517-6202 HUMAN PRESCRIPTION DRUG Multitrace-4 Neonatal Trace Elements 4 INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE HEPTAHYDRATE; CUPRIC SULFATE; MANGANESE SULFATE; CHROMIC CHLORIDE 6.6; .39; 77; 4.36 mg/mL; mg/mL; mg/mL; ug/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0517-6510_51f40bae-9b0e-4937-8f15-4e3e8dbeddd0 0517-6510 HUMAN PRESCRIPTION DRUG Selenium Selenium INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. SELENIOUS ACID 65.4 ug/mL N 20181231 0517-7201_1363db61-0998-419e-b305-a6a26538c2f8 0517-7201 HUMAN PRESCRIPTION DRUG Multitrace -4 Trace Elements 4 INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19931207 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE HEPTAHYDRATE; CUPRIC SULFATE; MANGANESE SULFATE; CHROMIC CHLORIDE 22; 3.93; 1.54; 51.3 mg/mL; mg/mL; mg/mL; ug/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0517-7210_1363db61-0998-419e-b305-a6a26538c2f8 0517-7210 HUMAN PRESCRIPTION DRUG Multitrace -4 Trace Elements 4 INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19931129 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE HEPTAHYDRATE; CUPRIC SULFATE; MANGANESE SULFATE; CHROMIC CHLORIDE 22; 3.93; 1.54; 51.3 mg/mL; mg/mL; mg/mL; ug/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0517-7410_6817d524-2100-4c8e-91c2-d1d2d999f31a 0517-7410 HUMAN PRESCRIPTION DRUG Multitrace-4 Trace Elements 4 INJECTION, SOLUTION INTRAVENOUS 19940217 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE HEPTAHYDRATE; CUPRIC SULFATE; MANGANESE SULFATE; CHROMIC CHLORIDE 4.39; 1.57; .308; 20.5 mg/mL; mg/mL; mg/mL; ug/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0517-7504_2fdbe3e6-e9ee-4f6f-b2f8-391bf741bc5f 0517-7504 HUMAN PRESCRIPTION DRUG Acetylcysteine acetylcysteine INHALANT RESPIRATORY (INHALATION) 19951001 ANDA ANDA072489 American Regent, Inc. ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 0517-7510_2fdbe3e6-e9ee-4f6f-b2f8-391bf741bc5f 0517-7510 HUMAN PRESCRIPTION DRUG Acetylcysteine acetylcysteine INHALANT RESPIRATORY (INHALATION) 19951001 ANDA ANDA072489 American Regent, Inc. ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 0517-7604_2fdbe3e6-e9ee-4f6f-b2f8-391bf741bc5f 0517-7604 HUMAN PRESCRIPTION DRUG Acetylcysteine acetylcysteine INHALANT RESPIRATORY (INHALATION) 19951001 ANDA ANDA072547 American Regent, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 0517-7610_2fdbe3e6-e9ee-4f6f-b2f8-391bf741bc5f 0517-7610 HUMAN PRESCRIPTION DRUG Acetylcysteine acetylcysteine INHALANT RESPIRATORY (INHALATION) 19951001 ANDA ANDA072547 American Regent, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 0517-7630_2fdbe3e6-e9ee-4f6f-b2f8-391bf741bc5f 0517-7630 HUMAN PRESCRIPTION DRUG Acetylcysteine acetylcysteine INHALANT RESPIRATORY (INHALATION) 19951001 ANDA ANDA072547 American Regent, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 0517-8105_2b34b312-43d0-460e-bd9e-5b35fea122e4 0517-8105 HUMAN PRESCRIPTION DRUG Zinc Sulfate Zinc Sulfate INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE ANHYDROUS 5 mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 0517-8201_dc0753e4-a17a-4020-bba8-8e78a40e031b 0517-8201 HUMAN PRESCRIPTION DRUG Multitrace-5 Trace Elements 5 INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19931217 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE HEPTAHYDRATE; CUPRIC SULFATE; MANGANESE SULFATE; CHROMIC CHLORIDE; SELENIOUS ACID 22; 3.93; 1.54; 51.3; 98 mg/mL; mg/mL; mg/mL; ug/mL; ug/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0517-8210_dc0753e4-a17a-4020-bba8-8e78a40e031b 0517-8210 HUMAN PRESCRIPTION DRUG Multitrace-5 Trace Elements 5 INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19930914 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE HEPTAHYDRATE; CUPRIC SULFATE; MANGANESE SULFATE; CHROMIC CHLORIDE; SELENIOUS ACID 22; 3.93; 1.54; 51.3; 98 mg/mL; mg/mL; mg/mL; ug/mL; ug/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0517-8510_9a7f5368-6696-4835-83da-b2358179720c 0517-8510 HUMAN PRESCRIPTION DRUG Multitrace-5 Trace Elements 5 INJECTION, SOLUTION INTRAVENOUS 19940217 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE HEPTAHYDRATE; CUPRIC SULFATE; MANGANESE SULFATE; CHROMIC CHLORIDE; SELENIOUS ACID 4.39; 1.57; .308; 20.5; 32.7 mg/mL; mg/mL; mg/mL; ug/mL; ug/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0517-8575_7731f98e-6263-4e1d-bba4-2ffd5c46a54f 0517-8575 HUMAN PRESCRIPTION DRUG Dehydrated Alcohol Dehydrated Alcohol INJECTION, SOLUTION INTRASPINAL 19900930 UNAPPROVED DRUG OTHER American Regent, Inc. ALCOHOL .98 mL/mL N 20181231 0517-8905_2627d4f7-5db1-49e0-bf19-0027ab27197b 0517-8905 HUMAN PRESCRIPTION DRUG Methyldopate Hydrochloride Methyldopate Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19950930 ANDA ANDA071279 American Regent, Inc. METHYLDOPATE HYDROCHLORIDE 50 mg/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0517-9120_a34e920d-92fc-4a62-9a35-fb19b35a116f 0517-9120 HUMAN PRESCRIPTION DRUG Aminocaproic Acid Aminocaproic Acid INJECTION, SOLUTION INTRAVENOUS 19900930 ANDA ANDA071192 American Regent, Inc. AMINOCAPROIC ACID 250 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 0517-9203_bf116d1d-8143-4ba5-a987-4dbfd2a695de 0517-9203 HUMAN PRESCRIPTION DRUG Multitrace -4 Pediatric Trace Elements 4 INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19931209 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE HEPTAHYDRATE; CUPRIC SULFATE; MANGANESE SULFATE; CHROMIC CHLORIDE 4.39; .4; 77; 5.12 mg/mL; mg/mL; ug/mL; ug/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0517-9310_0f5d052e-392d-4538-b2ff-c802bff561d2 0517-9310 HUMAN PRESCRIPTION DRUG Trace Elements 4 Trace Elements 4 INJECTION, SOLUTION INTRAVENOUS 19940224 UNAPPROVED DRUG OTHER American Regent, Inc. ZINC SULFATE HEPTAHYDRATE; CUPRIC SULFATE; MANGANESE SULFATE; CHROMIC CHLORIDE 2.2; .4; 92.3; 5.12 mg/mL; mg/mL; ug/mL; ug/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0517-9702_b135de7c-8def-431a-a5cc-1c1d98cc6161 0517-9702 HUMAN PRESCRIPTION DRUG Droperidol Droperidol INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19900930 ANDA ANDA072123 American Regent, Inc. DROPERIDOL 2.5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0519-1181_26901dd5-03af-431f-a4f9-e988a4423dc4 0519-1181 HUMAN OTC DRUG Cal Stat Plus Antiseptic Handrub with Enhanced Emollients Isopropyl Alcohol LIQUID TOPICAL 20110318 OTC MONOGRAPH NOT FINAL part333A STERIS Corporation ISOPROPYL ALCOHOL 63 mL/100mL N 20181231 0519-1206_2c7d53a4-cdfa-41b3-a224-4ff0d122e5f2 0519-1206 HUMAN OTC DRUG Acute-Kare Healthcare Personnel Handwash CHLOROXYLENOL SOAP TOPICAL 19950117 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation CHLOROXYLENOL 1 g/100mL N 20181231 0519-1229_9440d943-3cbb-45fb-8d0d-1b2e9e5e7d89 0519-1229 HUMAN OTC DRUG Medicated Soft N Sure Healthcare Personnel Handwash Triclosan LIQUID TOPICAL 19951101 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation TRICLOSAN .5 g/1000mL N 20181231 0519-1322_2e52fa58-76f0-40cb-8b1d-671fcd35b7c8 0519-1322 HUMAN OTC DRUG Bactoshield CHG Chlorhexidine Gluconate SOLUTION TOPICAL 19991004 NDA NDA019422 STERIS Corporation CHLORHEXIDINE GLUCONATE 20 mg/mL N 20181231 0519-1344_01ab5f17-2ccf-41d6-bd83-56c9a9b9f717 0519-1344 HUMAN OTC DRUG Bactoshield CHG CHLORHEXIDINE GLUCONATE SOLUTION TOPICAL 19991004 NDA NDA019125 STERIS Corporation CHLORHEXIDINE GLUCONATE 40 mg/mL N 20181231 0519-1357_5c05a90c-4289-4dc7-9b05-e3aa2b204030 0519-1357 HUMAN OTC DRUG Septisol NPD with Triclosan Antiseptic Triclosan LIQUID TOPICAL 20110325 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation TRICLOSAN .25 mL/100mL N 20181231 0519-1364_4f1c215d-d050-414c-b5d4-1f3173c265db 0519-1364 HUMAN OTC DRUG Bactoshield CHLORHEXIDINE GLUCONATE SPONGE TOPICAL 20030327 NDA NDA019822 STERIS Corporation CHLORHEXIDINE GLUCONATE 40 mg/mL N 20181231 0519-1381_4022b015-4653-413a-8435-5c59ca027a93 0519-1381 HUMAN OTC DRUG Soft N Sure Foamed Antiseptic Handrub ALCOHOL AEROSOL, FOAM TOPICAL 20060411 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 62 g/100g N 20181231 0519-1440_fb60bc84-0db8-4052-8d80-1f88b8240487 0519-1440 HUMAN OTC DRUG Soft N Sure Antiseptic Alcohol GEL TOPICAL 20110316 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 65 mL/100mL N 20181231 0519-1452_de18f0b8-6eb1-4750-917d-da97fe2d95fc 0519-1452 HUMAN OTC DRUG Kindest Kare Antimicrobial Foaming Handwash Healthcare Personnel Handwash Triclosan LIQUID TOPICAL 20060314 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation TRICLOSAN .75 g/100mL N 20181231 0519-1458_1299ad44-99e2-432d-9820-de048eff0b8f 0519-1458 HUMAN OTC DRUG Kindest Kare Air-Infused Foam Antiseptic Handrub ALCOHOL LIQUID TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 62 mg/100mL N 20181231 0519-6262_c88e37f9-0980-4f24-b95a-43749b193521 0519-6262 HUMAN OTC DRUG CV Medicated TRICLOSAN SOAP TOPICAL 20030327 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation TRICLOSAN .5 g/100mL N 20181231 0519-6264_78fc580f-7def-4088-8f77-5c8ec680e006 0519-6264 HUMAN OTC DRUG Kindest Kare Advanced Antimicrobial Foam Handwash BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160615 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation BENZALKONIUM CHLORIDE .5 mg/100mL N 20181231 0519-6267_e0428fac-1348-4d65-b4c1-4b719f1b44ac 0519-6267 HUMAN OTC DRUG Kindest Kare Advanced Antimicrobial Handwash BENZALKONIUM CHLORIDE LIQUID TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation BENZALKONIUM CHLORIDE .7 mg/100mL N 20181231 0519-6395_6e8bb5ff-c2e7-4b4b-98df-eb4b29719788 0519-6395 HUMAN OTC DRUG Alcare Foamed Antiseptic Handrub ALCOHOL AEROSOL, FOAM TOPICAL 19980120 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 62 g/100g N 20181231 0519-6396_222427a6-625d-4c4d-b014-c240e5cc2d57 0519-6396 HUMAN OTC DRUG Alcare OR Foamed Antiseptic Handrub ALCOHOL AEROSOL, FOAM TOPICAL 20050208 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 62 g/100g N 20181231 0519-6399_2f31f26b-f9c4-424e-b23a-01ab2a6d1edc 0519-6399 HUMAN OTC DRUG Alcare Plus Foamed Antiseptic Handrub alcohol AEROSOL, FOAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333E STERIS Corporation ALCOHOL 62 g/100g N 20181231 0519-8802_60037006-7a09-4108-b6b8-ad6d06bb054a 0519-8802 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140908 OTC MONOGRAPH NOT FINAL part333A Steris Corporation ALCOHOL 578 mg/mL N 20181231 0527-0586_2f2b6c5f-86cd-40a2-831b-96a4dda168a1 0527-0586 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 Lannett Company, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0527-0597_fdd1f6a6-0420-441f-af5c-cf85eb213a62 0527-0597 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0527-1050_84acb9aa-f9d1-442a-90f8-45e698638769 0527-1050 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE Acetazolamide TABLET ORAL 19780331 ANDA ANDA084840 Lannett Company, Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 0527-1109_027aaa02-785c-4eec-811a-0b555f987b95 0527-1109 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL; ORAL 20131010 ANDA ANDA089776 Lannett Company, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 0527-1170_438208a6-4c38-4c1f-a804-243b6a76bc60 0527-1170 HUMAN PRESCRIPTION DRUG DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET ORAL 19780221 ANDA ANDA085372 Lannett Company, Inc. DIPHENOXYLATE; ATROPINE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 0527-1210_fa845556-f91b-4526-baa0-f914b2a4ac02 0527-1210 HUMAN PRESCRIPTION DRUG Neomycin Sulfate Neomycin Sulfate TABLET ORAL 20160610 ANDA ANDA204435 Lannett Company, Inc. NEOMYCIN SULFATE 500 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0527-1221_73b8b0a6-e196-4d55-9b59-12b9a5342974 0527-1221 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20161110 ANDA ANDA207236 Lannett Company, Inc. MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0527-1222_73b8b0a6-e196-4d55-9b59-12b9a5342974 0527-1222 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20161110 ANDA ANDA207236 Lannett Company, Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0527-1231_e86f4a99-d4d9-4ef7-9a1b-7461530d470d 0527-1231 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 19781201 ANDA ANDA084903 Lannett Company, Inc. PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0527-1282_2f2b6c5f-86cd-40a2-831b-96a4dda168a1 0527-1282 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19990226 ANDA ANDA040230 Lannett Company, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0527-1301_e86f4a99-d4d9-4ef7-9a1b-7461530d470d 0527-1301 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20010524 ANDA ANDA084903 Lannett Company, Inc. PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0527-1308_fdd1f6a6-0420-441f-af5c-cf85eb213a62 0527-1308 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0527-1310_fdd1f6a6-0420-441f-af5c-cf85eb213a62 0527-1310 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0527-1311_ff66b251-a861-4a6b-945d-4478b2bbaae9 0527-1311 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20050325 ANDA ANDA077152 Lannett Company, Inc. TERBUTALINE SULFATE 5 mg/1 N 20181231 0527-1312_2226a799-64cc-4e4d-8f4c-2045afd00063 0527-1312 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE ORAL 19980831 ANDA ANDA074951 Lannett Company, Inc. BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0527-1313_3ad20698-d8de-4b6e-8154-ab98a92ed0dc 0527-1313 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET, FILM COATED ORAL 20060131 ANDA ANDA077220 Lannett Company, Inc. PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 0527-1315_07b57d52-3172-4651-85ad-348bc7db3a81 0527-1315 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20080420 ANDA ANDA065390 Lannett Company, Inc. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20191231 0527-1318_ff66b251-a861-4a6b-945d-4478b2bbaae9 0527-1318 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20050325 ANDA ANDA077152 Lannett Company, Inc. TERBUTALINE SULFATE 2.5 mg/1 N 20181231 0527-1324_c240d91d-2c25-4fd4-a900-d01b4df045d0 0527-1324 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Lannett Company, Inc. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0527-1325_c240d91d-2c25-4fd4-a900-d01b4df045d0 0527-1325 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Lannett Company, Inc. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0527-1326_ad833237-5e8a-4391-87e7-fcb7b89d7614 0527-1326 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20090101 ANDA ANDA079082 Lannett Company, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 0527-1329_e612c3eb-e7f8-4aa8-babf-14bbe08794f8 0527-1329 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20080327 ANDA ANDA040677 Lannett Company, Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0527-1330_5b140638-ebd7-41c6-a920-603c05b1bf8d 0527-1330 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20070701 ANDA ANDA078220 Lannett Company, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 0527-1332_e612c3eb-e7f8-4aa8-babf-14bbe08794f8 0527-1332 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20080327 ANDA ANDA040703 Lannett Company, Inc. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0527-1335_a02cb4f0-f517-48ef-8a91-e2a795b539ff 0527-1335 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20051208 ANDA ANDA065285 Lannett Company, Inc. DOXYCYCLINE 50 mg/1 N 20191231 0527-1336_d909806c-cdd0-4860-b68f-cd5a8b72815d 0527-1336 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20051110 ANDA ANDA065277 Lannett Company, Inc. DOXYCYCLINE HYCLATE 20 mg/1 N 20181231 0527-1337_5b140638-ebd7-41c6-a920-603c05b1bf8d 0527-1337 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20051201 ANDA ANDA077241 Lannett Company, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 0527-1338_a02cb4f0-f517-48ef-8a91-e2a795b539ff 0527-1338 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20051208 ANDA ANDA065285 Lannett Company, Inc. DOXYCYCLINE 100 mg/1 N 20191231 0527-1340_e612c3eb-e7f8-4aa8-babf-14bbe08794f8 0527-1340 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20080327 ANDA ANDA040704 Lannett Company, Inc. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0527-1341_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1341 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1342_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1342 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1343_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1343 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1344_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1344 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1345_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1345 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1346_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1346 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1347_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1347 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1349_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1349 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1350_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1350 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1351_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1351 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1352_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1352 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .3 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1353_70263d8a-1f22-4fb0-85cf-7888ddc12113 0527-1353 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA077471 Lannett Company, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0527-1354_70263d8a-1f22-4fb0-85cf-7888ddc12113 0527-1354 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA077471 Lannett Company, Inc. HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0527-1355_70263d8a-1f22-4fb0-85cf-7888ddc12113 0527-1355 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA077471 Lannett Company, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0527-1356_e612c3eb-e7f8-4aa8-babf-14bbe08794f8 0527-1356 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20080327 ANDA ANDA040678 Lannett Company, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0527-1366_7bbef403-d696-4690-a1b1-8fd2d48eb52e 0527-1366 HUMAN PRESCRIPTION DRUG Phentermine Resin ER Phentermine Resin CAPSULE, EXTENDED RELEASE ORAL 20110728 ANDA ANDA040872 Lannett Company, Inc. PHENTERMINE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0527-1367_c2d5b0b5-a59e-41e4-9e11-4fa9e1da7f5c 0527-1367 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 19760729 ANDA ANDA080966 Lannett Company, Inc. PROBENECID 500 mg/1 N 20181231 0527-1368_e539f0cd-a2bb-4089-95a3-7679f6d1245f 0527-1368 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20070419 ANDA ANDA078214 Lannett Company, Inc. DANAZOL 100 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 0527-1369_e539f0cd-a2bb-4089-95a3-7679f6d1245f 0527-1369 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20050928 ANDA ANDA077246 Lannett Company, Inc. DANAZOL 200 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 0527-1370_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1370 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1371_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1371 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1372_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1372 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1373_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1373 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1374_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1374 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1375_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1375 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1376_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1376 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1377_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1377 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1378_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1378 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1379_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1379 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1380_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1380 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20000821 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .3 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1381_0aa564fb-f783-4f4a-8233-f6bbab21e00f 0527-1381 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20050812 ANDA ANDA065242 Lannett Company, Inc. CLINDAMYCIN HYDROCHLORIDE 75 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0527-1382_0aa564fb-f783-4f4a-8233-f6bbab21e00f 0527-1382 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20050812 ANDA ANDA065242 Lannett Company, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0527-1383_0aa564fb-f783-4f4a-8233-f6bbab21e00f 0527-1383 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20050812 ANDA ANDA065243 Lannett Company, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0527-1392_e539f0cd-a2bb-4089-95a3-7679f6d1245f 0527-1392 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20070419 ANDA ANDA078214 Lannett Company, Inc. DANAZOL 50 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 0527-1393_07b57d52-3172-4651-85ad-348bc7db3a81 0527-1393 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20080420 ANDA ANDA065390 Lannett Company, Inc. RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20191231 0527-1394_b09ee13f-c5b2-4708-a640-69012b180a86 0527-1394 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20110926 ANDA ANDA090695 Lannett Company, Inc. LOXAPINE SUCCINATE 5 mg/1 N 20181231 0527-1395_b09ee13f-c5b2-4708-a640-69012b180a86 0527-1395 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20110926 ANDA ANDA090695 Lannett Company, Inc. LOXAPINE SUCCINATE 10 mg/1 N 20181231 0527-1396_b09ee13f-c5b2-4708-a640-69012b180a86 0527-1396 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20110926 ANDA ANDA090695 Lannett Company, Inc. LOXAPINE SUCCINATE 25 mg/1 N 20181231 0527-1397_b09ee13f-c5b2-4708-a640-69012b180a86 0527-1397 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20110926 ANDA ANDA090695 Lannett Company, Inc. LOXAPINE SUCCINATE 50 mg/1 N 20181231 0527-1398_7bbef403-d696-4690-a1b1-8fd2d48eb52e 0527-1398 HUMAN PRESCRIPTION DRUG Phentermine Resin ER Phentermine Resin CAPSULE, EXTENDED RELEASE ORAL 20110728 ANDA ANDA040872 Lannett Company, Inc. PHENTERMINE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0527-1407_3ad20698-d8de-4b6e-8154-ab98a92ed0dc 0527-1407 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077220 Lannett Company, Inc. PILOCARPINE HYDROCHLORIDE 7.5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 0527-1413_23da94e7-00ec-465e-9ab5-82e3e411f194 0527-1413 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070501 ANDA ANDA084325 Lannett Company, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0527-1414_23da94e7-00ec-465e-9ab5-82e3e411f194 0527-1414 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070501 ANDA ANDA084324 Lannett Company, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0527-1425_925dd207-8960-4417-be8d-fce01ca7e7e8 0527-1425 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION, CONCENTRATE ORAL 20110623 NDA NDA201517 Lannett Company, Inc. MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0527-1426_ce2892ff-d5cb-4973-a141-f1c5c765fa7e 0527-1426 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20140910 ANDA ANDA204085 Lannett Company, Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0527-1435_8a6bb975-77d1-42ce-918d-f3c0df60ff5f 0527-1435 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20161122 ANDA ANDA204770 Lannett Company, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 0527-1438_fdd1f6a6-0420-441f-af5c-cf85eb213a62 0527-1438 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20100719 ANDA ANDA091359 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0527-1445_5c4936c8-8072-4ba1-8bc1-6392cfd21d80 0527-1445 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20050415 ANDA ANDA040555 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0527-1461_2210856e-0bac-4af3-89cd-238b46efe6e2 0527-1461 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080423 ANDA ANDA040898 Lannett Company, Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0527-1462_2210856e-0bac-4af3-89cd-238b46efe6e2 0527-1462 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080423 ANDA ANDA040898 Lannett Company, Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0527-1463_2210856e-0bac-4af3-89cd-238b46efe6e2 0527-1463 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080423 ANDA ANDA040898 Lannett Company, Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0527-1475_51364fcd-6cfb-4283-b9b0-1be485315782 0527-1475 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride Diethylpropion Hydrochloride TABLET ORAL 20110718 ANDA ANDA200177 Lannett Company, Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0527-1477_b35ce34e-d9fa-42ea-b9a5-e6225dc9a980 0527-1477 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride ER Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111024 ANDA ANDA091680 Lannett Company, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0527-1535_a02cb4f0-f517-48ef-8a91-e2a795b539ff 0527-1535 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20080825 ANDA ANDA065285 Lannett Company, Inc. DOXYCYCLINE 75 mg/1 N 20191231 0527-1537_a02cb4f0-f517-48ef-8a91-e2a795b539ff 0527-1537 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20080825 ANDA ANDA065285 Lannett Company, Inc. DOXYCYCLINE 150 mg/1 N 20191231 0527-1552_d4fb7c25-43e8-46ca-be21-c99550d1483d 0527-1552 HUMAN PRESCRIPTION DRUG Butalbital, aspirin, and caffeine Butalbital, aspirin, and caffeine CAPSULE ORAL 19851011 ANDA ANDA086996 Lannett Company, Inc. BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 0527-1632_1faaf6d1-03a5-48ab-bb03-726ed3f0e4ef 0527-1632 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20111212 ANDA ANDA201407 Lannett Company, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0527-1635_1d8e77d7-2c00-4f9a-bea8-245641d3cd4a 0527-1635 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20120127 ANDA ANDA091662 Lannett Company, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0527-1638_26a25b2e-75a8-4a96-8dad-e10ea25e6d72 0527-1638 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1639_e9482dd8-6ffe-46f7-a58e-9efbb32ff4ee 0527-1639 HUMAN PRESCRIPTION DRUG UNITHROID levothyroxine sodium TABLET ORAL 20071001 NDA NDA021210 Lannett Company, Inc. LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0527-1646_33f695bb-1ab0-4e2d-a0f9-cd183abb33ce 0527-1646 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170620 ANDA ANDA207171 Lannett Company, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0527-1647_33f695bb-1ab0-4e2d-a0f9-cd183abb33ce 0527-1647 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170620 ANDA ANDA207171 Lannett Company, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0527-1648_33f695bb-1ab0-4e2d-a0f9-cd183abb33ce 0527-1648 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170620 ANDA ANDA207171 Lannett Company, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0527-1649_ffebc600-5e38-4551-98ad-7cd93c1dcada 0527-1649 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170622 ANDA ANDA207172 Lannett Company, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0527-1650_ffebc600-5e38-4551-98ad-7cd93c1dcada 0527-1650 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170622 ANDA ANDA207172 Lannett Company, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0527-1651_ffebc600-5e38-4551-98ad-7cd93c1dcada 0527-1651 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170622 ANDA ANDA207172 Lannett Company, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0527-1669_c4867748-4e98-494b-94eb-6e416eca427a 0527-1669 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20170925 ANDA ANDA207333 Lannett Company, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0527-1671_c4867748-4e98-494b-94eb-6e416eca427a 0527-1671 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20170925 ANDA ANDA207333 Lannett Company, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0527-1695_255f4f08-3a2f-4f11-a8c6-eda3345f6a7f 0527-1695 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20120913 ANDA ANDA200243 Lannett Company, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0527-1698_2133b788-41c2-4fe0-9d4c-18942e9212ab 0527-1698 HUMAN PRESCRIPTION DRUG Codeine Sulfate Codeine Sulfate TABLET ORAL 20140613 ANDA ANDA203046 Lannett Company, Inc. CODEINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0527-1699_2133b788-41c2-4fe0-9d4c-18942e9212ab 0527-1699 HUMAN PRESCRIPTION DRUG Codeine Sulfate Codeine Sulfate TABLET ORAL 20140613 ANDA ANDA203046 Lannett Company, Inc. CODEINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0527-1704_64f41f85-5e90-45e6-b0c1-b05ec665ea68 0527-1704 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 20081101 ANDA ANDA078720 Lannett Company, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 0527-1726_b20b17b3-0df1-4773-96a5-67ba52bf23d1 0527-1726 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20100701 ANDA ANDA090116 Lannett Company, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0527-1727_2133b788-41c2-4fe0-9d4c-18942e9212ab 0527-1727 HUMAN PRESCRIPTION DRUG Codeine Sulfate Codeine Sulfate TABLET ORAL 20140613 ANDA ANDA203046 Lannett Company, Inc. CODEINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0527-1728_904467d4-a159-4e26-95b5-0d677a96e385 0527-1728 HUMAN PRESCRIPTION DRUG Cocaine Hydrochloride Cocaine Hydrochloride SOLUTION TOPICAL 20081201 UNAPPROVED DRUG OTHER Lannett Company, Inc. COCAINE HYDROCHLORIDE 40 mg/mL CII N 20181231 0527-1729_904467d4-a159-4e26-95b5-0d677a96e385 0527-1729 HUMAN PRESCRIPTION DRUG Cocaine Hydrochloride Cocaine Hydrochloride SOLUTION TOPICAL 20081201 UNAPPROVED DRUG OTHER Lannett Company, Inc. COCAINE HYDROCHLORIDE 100 mg/mL CII N 20181231 0527-1742_fdd1f6a6-0420-441f-af5c-cf85eb213a62 0527-1742 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120120 ANDA ANDA087022 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0527-1743_d59212b2-dcee-43c4-9b2d-18eb2edddc9b 0527-1743 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20110720 ANDA ANDA201961 Lannett Company, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0527-1763_b981255a-fe82-4953-9f3c-04977df0d9d2 0527-1763 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride-Timolol Maleate Dorzolamide Hydrochloride-Timolol Maleate SOLUTION OPHTHALMIC 20141217 ANDA ANDA201998 Lannett Company, Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0527-1767_2a8b59ea-d846-4e66-b449-f2522a6f2e4e 0527-1767 HUMAN PRESCRIPTION DRUG Diazepam Diazepam SOLUTION ORAL 20160624 ANDA ANDA206477 Lannett Company, Inc. DIAZEPAM 5 mg/5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0527-1768_2a8b59ea-d846-4e66-b449-f2522a6f2e4e 0527-1768 HUMAN PRESCRIPTION DRUG Diazepam Diazepam SOLUTION, CONCENTRATE ORAL 20140414 ANDA ANDA204433 Lannett Company, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0527-1774_2d019e36-8f61-429d-bed0-5f127a2b7d10 0527-1774 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20140801 ANDA ANDA203823 Lannett Company, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0527-1777_c06a20ea-8ac5-4611-a90b-00265e84f497 0527-1777 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160323 ANDA ANDA202750 Lannett Company, Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0527-1778_c06a20ea-8ac5-4611-a90b-00265e84f497 0527-1778 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160323 ANDA ANDA202750 Lannett Company, Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0527-1779_c06a20ea-8ac5-4611-a90b-00265e84f497 0527-1779 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160323 ANDA ANDA202750 Lannett Company, Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0527-1780_c06a20ea-8ac5-4611-a90b-00265e84f497 0527-1780 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160323 ANDA ANDA202750 Lannett Company, Inc. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0527-1781_c06a20ea-8ac5-4611-a90b-00265e84f497 0527-1781 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160323 ANDA ANDA202750 Lannett Company, Inc. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0527-1782_c06a20ea-8ac5-4611-a90b-00265e84f497 0527-1782 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160323 ANDA ANDA202750 Lannett Company, Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0527-1788_375e4b05-a5c1-4679-9520-b50e78f3e865 0527-1788 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20100927 ANDA ANDA089740 Lannett Company, Inc. FLUPHENAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0527-1789_375e4b05-a5c1-4679-9520-b50e78f3e865 0527-1789 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20100927 ANDA ANDA089741 Lannett Company, Inc. FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0527-1790_375e4b05-a5c1-4679-9520-b50e78f3e865 0527-1790 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20100927 ANDA ANDA089742 Lannett Company, Inc. FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0527-1791_375e4b05-a5c1-4679-9520-b50e78f3e865 0527-1791 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20100927 ANDA ANDA089743 Lannett Company, Inc. FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0527-1818_04733454-0f9f-4bd7-912f-fde83f0b8051 0527-1818 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan SPRAY NASAL 20160219 ANDA ANDA204841 Lannett Company, Inc. SUMATRIPTAN 5 mg/.1mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0527-1859_04733454-0f9f-4bd7-912f-fde83f0b8051 0527-1859 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan SPRAY NASAL 20160219 ANDA ANDA204841 Lannett Company, Inc. SUMATRIPTAN 20 mg/.1mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0527-1868_aac34664-21c1-4d1f-81ba-3f3309efbe2f 0527-1868 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 20170615 ANDA ANDA209221 Lannett Company, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 0527-1905_3a55f8ca-3601-494f-e054-00144ff8d46c 0527-1905 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20140325 ANDA ANDA202058 Lannett Company, Inc. ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0527-1906_925dd207-8960-4417-be8d-fce01ca7e7e8 0527-1906 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION, CONCENTRATE ORAL 20110623 NDA NDA201517 Lannett Company, Inc. MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0527-1917_e19a23a5-a145-4dba-a184-9a0791cb71fd 0527-1917 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride SOLUTION ORAL 20170515 ANDA ANDA204599 Lannett Company, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0527-1919_3c07919a-a38c-4a38-a761-65196c8c7883 0527-1919 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20141001 NDA NDA020184 Lannett Company, Inc. PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0527-1920_3c07919a-a38c-4a38-a761-65196c8c7883 0527-1920 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20141001 NDA NDA020184 Lannett Company, Inc. PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0527-1931_6057cede-64d5-7fdc-e053-2a91aa0a0bd3 0527-1931 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20151204 ANDA ANDA203584 Lannett Company, Inc. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0527-1932_6057cede-64d5-7fdc-e053-2a91aa0a0bd3 0527-1932 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20151204 ANDA ANDA203584 Lannett Company, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0527-1943_2ca0e176-e7dc-4582-8e35-ea7ce1da991d 0527-1943 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride SOLUTION ORAL 20151013 ANDA ANDA204033 Lannett Company, Inc. MEMANTINE HYDROCHLORIDE 2 mg/mL NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0527-1947_3d8b49db-9ffb-471f-a227-73afa30f6f3d 0527-1947 HUMAN PRESCRIPTION DRUG Lopinavir-Ritonavir Lopinavir-Ritonavir SOLUTION ORAL 20161227 ANDA ANDA207407 Lannett Company, Inc. LOPINAVIR; RITONAVIR 80; 20 mg/mL; mg/mL HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0527-1949_5dd5dcf6-6a9c-4ac8-a124-7d7ec54f3cb5 0527-1949 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride SOLUTION ORAL 20170713 ANDA ANDA203191 Lannett Company, Inc. CYPROHEPTADINE HYDROCHLORIDE 2 mg/5mL N 20181231 0527-2600_fdf4f86e-ef56-42a4-85f1-5c5a5e21a0d2 0527-2600 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20180101 NDA AUTHORIZED GENERIC NDA019962 Lannett Company, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 0527-2601_fdf4f86e-ef56-42a4-85f1-5c5a5e21a0d2 0527-2601 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20180101 NDA AUTHORIZED GENERIC NDA019962 Lannett Company, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 0527-2602_fdf4f86e-ef56-42a4-85f1-5c5a5e21a0d2 0527-2602 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20180101 NDA AUTHORIZED GENERIC NDA019962 Lannett Company, Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 0527-2603_fdf4f86e-ef56-42a4-85f1-5c5a5e21a0d2 0527-2603 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20180101 NDA AUTHORIZED GENERIC NDA019962 Lannett Company, Inc. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 0536-0015_60cc8607-b24b-f358-e053-2a91aa0a5e5b 0536-0015 HUMAN OTC DRUG ALMACONE DOUBLE STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110105 OTC MONOGRAPH FINAL part331 RUGBY LABORATORIES ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 0536-0025_60cc56d0-ee4f-e1dd-e053-2991aa0a104a 0536-0025 HUMAN OTC DRUG ALMACONE ANTACID ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110105 OTC MONOGRAPH FINAL part331 RUGBY LABORATORIES ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 0536-0091_5e0c3967-d2b0-4acb-e053-2a91aa0af2bf 0536-0091 HUMAN OTC DRUG Aluminum Hydroxide aluminum hydroxide LIQUID ORAL 20050201 OTC MONOGRAPH FINAL part331 Rugby Laboratories ALUMINUM HYDROXIDE 320 mg/5mL N 20181231 0536-0122_3975b232-cd30-4076-a3ce-1bbc323e1891 0536-0122 HUMAN OTC DRUG Rugby Acetaminophen Acetaminophen LIQUID ORAL 20110428 OTC MONOGRAPH NOT FINAL part343 Rugby Laboratories, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 0536-0355_75e5bef2-e044-4d11-8a79-29d039a50f35 0536-0355 HUMAN OTC DRUG Docusate Sodium and Senna Docusate Sodium and Senna TABLET, FILM COATED ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 0536-0370_3065bc51-c210-483b-876d-14a4d060bdec 0536-0370 HUMAN OTC DRUG Aller-Chlor Chlorpheniramine Maleate SYRUP ORAL 20030117 OTC MONOGRAPH FINAL part341 Rugby Laboratories, Inc. CHLORPHENIRAMINE MALEATE 2 mg/5mL E 20171231 0536-0590_6278090d-1a6a-4085-bc4a-a2e2ed3a2662 0536-0590 HUMAN OTC DRUG Diocto Docusate Sodium LIQUID ORAL 20130301 20190930 OTC MONOGRAPH NOT FINAL part334 The Harvard Drug Group, LLC DOCUSATE SODIUM 50 mg/5mL N 20191231 0536-0600_afac6c3d-a513-4655-9545-3e489f26558a 0536-0600 HUMAN OTC DRUG Diocto docusate sodium SYRUP ORAL 19991001 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc. DOCUSATE SODIUM 60 mg/15mL E 20171231 0536-0770_3e10772a-5853-43e5-b8b6-93e4dcfd0da4 0536-0770 HUMAN OTC DRUG Diphenhist Diphenhydramine Hydrochloride LIQUID ORAL 20090926 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 0536-0810_57391419-7fdf-49d8-bac7-0ce353f0a835 0536-0810 HUMAN OTC DRUG ACNE MEDICATION 5 BENZOYL PEROXIDE LOTION TOPICAL 20121029 OTC MONOGRAPH FINAL part333D Rugby Laboratories BENZOYL PEROXIDE 50 mg/1000mL E 20171231 0536-0815_d4e80132-a7d9-453c-813b-fbcf883f198e 0536-0815 HUMAN OTC DRUG ACNE MEDICATION 10 BENZOYL PEROXIDE LOTION TOPICAL 20121029 OTC MONOGRAPH FINAL part333D Rugby Laboratories BENZOYL PEROXIDE 100 mg/1000mL E 20171231 0536-0825_c0c9a2b6-745b-406a-94ac-81d3fb6c62ed 0536-0825 HUMAN OTC DRUG Cough Guaifenesin LIQUID ORAL 20091204 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. GUAIFENESIN 100 mg/5mL N 20181231 0536-0901_dfe515f7-90d3-46f1-988c-ce5d9f083d4b 0536-0901 HUMAN OTC DRUG Eye Irrigating Purified Water SOLUTION OPHTHALMIC 20111007 UNAPPROVED DRUG OTHER Rugby Laboratories Inc. WATER 99.05 mL/100mL E 20171231 0536-0940_7f4b0600-8d8c-40e1-bd95-27020894995e 0536-0940 HUMAN OTC DRUG Eye Drops Tetrahydrozoline HCl SOLUTION/ DROPS OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 Rugby Laboratories Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 0536-0970_d1e79e3e-5ea5-451d-b2e3-8f1477c6079f 0536-0970 HUMAN OTC DRUG Extra action Cough Guaifenesin and DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20110203 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20191231 0536-1000_5f6f41df-7a68-4cd2-a1c4-2b1bde5bd2fe 0536-1000 HUMAN OTC DRUG Senexon Sennosides A and B SYRUP ORAL 20130215 OTC MONOGRAPH NOT FINAL part334 The Harvard Drug Group, LLC SENNOSIDES A AND B 8.8 mg/5mL E 20171231 0536-1001_65d6d66a-bdaf-4cba-93e3-e73f3029b102 0536-1001 HUMAN OTC DRUG Diocto Docusate Sodium SYRUP ORAL 20130601 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories DOCUSATE SODIUM 60 mg/15mL E 20171231 0536-1002_39ed24f0-4a60-4db4-8831-9a9edf1c2321 0536-1002 HUMAN OTC DRUG Rugby Eye Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20130630 OTC MONOGRAPH FINAL part349 Rugby Laboratories, Inc. TETRAHYDROZOLINE HYDROCHLORIDE .05 mg/mg N 20181231 0536-1003_d22db5f2-49d3-409e-a460-4e09b53f90f8 0536-1003 HUMAN OTC DRUG ACETA-GESIC ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20140630 OTC MONOGRAPH FINAL part341 Rugby Laboratories ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 325; 12.5 mg/1; mg/1 N 20181231 0536-1004_18d9ecaa-7be6-419c-9aa2-231b2e55c82a 0536-1004 HUMAN OTC DRUG Aspirin aspirin TABLET, COATED ORAL 20140114 OTC MONOGRAPH FINAL part343 RUGBY LABORATORIES, INC ASPIRIN 81 mg/1 N 20181231 0536-1005_aae97a60-526e-44f7-bdd8-62f918f65f6d 0536-1005 HUMAN OTC DRUG Childrens Allergy Fexofenadine Hydrochloride Fexofenadine Hydrochloride SUSPENSION ORAL 20141219 ANDA ANDA203330 Rugby Laboratories FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 0536-1006_077f9fc7-c054-4bfd-b40b-e627dacafea4 0536-1006 HUMAN OTC DRUG Aller-chlor Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Rugby Laboratories CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 0536-1007_a43184c4-d225-4539-b651-4d96535f208f 0536-1007 HUMAN OTC DRUG Rugby Cal-Gest Antacid Assorted Flavors Antacid Tablets TABLET, CHEWABLE ORAL 20140812 OTC MONOGRAPH FINAL part331 Rugby Laboratories, Inc. CALCIUM CARBONATE 500 mg/1 N 20181231 0536-1008_76332fcf-2513-420b-b956-d7fc5bcc8eb3 0536-1008 HUMAN OTC DRUG Rugby Aspirin Aspirin TABLET, CHEWABLE ORAL 20140321 OTC MONOGRAPH NOT FINAL part343 Rugby Laboratories ASPIRIN 81 mg/1 N 20181231 0536-1010_1d1911ca-3dea-4f3a-a604-01b8999d9d7e 0536-1010 HUMAN OTC DRUG Diphenhist Diphenhydramine HCl CAPSULE ORAL 20140317 OTC MONOGRAPH FINAL part336 Rugby Laboratories DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0536-1011_7f64a217-9842-4b13-8df1-e62753d1dfe4 0536-1011 HUMAN OTC DRUG Almacone Aluminum hydroxide, Magnesium hydroxide, Simethicone TABLET, CHEWABLE ORAL 20140123 OTC MONOGRAPH FINAL part332 Rugby Laboratories ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 25 mg/1; mg/1; mg/1 N 20181231 0536-1012_418035e3-fbb6-470a-983b-27a1c4d83d31 0536-1012 HUMAN OTC DRUG Earwax Treatment Drops Carbamide Peroxide SOLUTION AURICULAR (OTIC) 20141210 OTC MONOGRAPH FINAL part344 Rugby Laboratories CARBAMIDE PEROXIDE 81.86 mg/mL E 20171231 0536-1013_67ba2cc8-fb6a-4c5b-bfe2-e755742eabb3 0536-1013 HUMAN OTC DRUG Nasal Relief Oxymetazoline Hydrochloride SPRAY NASAL 20140714 OTC MONOGRAPH FINAL part341 Rugby Laboratories OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 0536-1014_5ed1b9e0-5d76-52ed-e053-2991aa0ac4b7 0536-1014 HUMAN OTC DRUG Pain and Fever Acetaminophen TABLET, CHEWABLE ORAL 20131201 OTC MONOGRAPH NOT FINAL part343 RUGBY LABORATORIES ACETAMINOPHEN 80 mg/1 N 20181231 0536-1015_53ab8a94-d2bd-6d1e-e054-00144ff8d46c 0536-1015 HUMAN OTC DRUG Rugby Acetaminophen 500 mg and Diphenhydramine HCl 25 mg Pain Reliever/Sleep Aid Acetaminophen,Diphenhydramine HCl TABLET, FILM COATED ORAL 20140826 OTC MONOGRAPH NOT FINAL part343 RUGBY LABORATORIES ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0536-1016_45ec77c5-5ec7-0e51-e054-00144ff8d46c 0536-1016 HUMAN OTC DRUG Rugby Diphenhist Diphenhydramine HCl TABLET, FILM COATED ORAL 20141213 OTC MONOGRAPH FINAL part341 RUGBY LABORATORIES DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0536-1017_45ebd205-f739-251c-e054-00144ff88e88 0536-1017 HUMAN OTC DRUG Rugby Meclizine HCl, 12.5 mg Each Antiemetic Meclizine HCl TABLET ORAL 20140307 OTC MONOGRAPH FINAL part336 RUGBY LABORATORIES MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 0536-1018_45eb5078-cb5c-1441-e054-00144ff88e88 0536-1018 HUMAN OTC DRUG Rugby Travel Sickness Meclizine HCl, 25 mg Each (Antiemetic) Meclizine HCl TABLET, CHEWABLE ORAL 20140819 OTC MONOGRAPH FINAL part336 RUGBY LABORATORIES MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 0536-1019_52f57529-53ef-60be-e054-00144ff8d46c 0536-1019 HUMAN OTC DRUG Rugby Gas Relief ANTIFLATULENT 80 mg each Simethicone TABLET, CHEWABLE ORAL 20140825 OTC MONOGRAPH FINAL part332 RUGBY LABORATORIES DIMETHICONE 80 mg/1 N 20181231 0536-1020_52f61301-c4f4-5cf9-e054-00144ff88e88 0536-1020 HUMAN OTC DRUG Maximum Strength Gas Relief ANTIFLATULENT Simethicone TABLET, CHEWABLE ORAL 20140527 OTC MONOGRAPH FINAL part332 RUGBY LABORATORIES DIMETHICONE 125 mg/1 N 20181231 0536-1021_22a1a88e-6128-49d5-a147-2484186f640b 0536-1021 HUMAN OTC DRUG Peptic Relief Peptic Relief TABLET ORAL 20140220 OTC MONOGRAPH FINAL part335 Rugby Laboratories BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 0536-1022_8b0b968a-70e3-4f6d-af0e-6e78345d4545 0536-1022 HUMAN OTC DRUG All Day Relief Naproxen Sodium, Coated Tablets TABLET ORAL 20140310 ANDA ANDA090545 Rugby Laboratories NAPROXEN SODIUM 220 mg/1 N 20181231 0536-1023_8b0b968a-70e3-4f6d-af0e-6e78345d4545 0536-1023 HUMAN OTC DRUG All Day Relief Naproxen Sodium Tablet, coated TABLET ORAL 20140310 ANDA ANDA090545 Rugby Laboratories NAPROXEN SODIUM 220 mg/1 N 20181231 0536-1024_50ab4f92-e9ac-4b06-89c3-37d521198b55 0536-1024 HUMAN OTC DRUG Rugby Calcium Carbonate 10 gr Antacid Tablets TABLET, CHEWABLE ORAL 20140207 OTC MONOGRAPH FINAL part331 Rugby Laboratories, Inc. CALCIUM CARBONATE 648 mg/1 N 20181231 0536-1025_a33242a3-2b57-4cff-92c5-7c81a33f441b 0536-1025 HUMAN OTC DRUG Aller-chlor Chlorpheniramine Maleate SYRUP ORAL 20140320 OTC MONOGRAPH FINAL part341 Rugby Laboratories CHLORPHENIRAMINE MALEATE 2 mg/5mL E 20171231 0536-1034_6ff64139-08b2-4f3f-a135-767b312b80c7 0536-1034 HUMAN OTC DRUG Rugby Heartburn Treatment Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20140505 ANDA ANDA202319 Rugby Laboratories LANSOPRAZOLE 15 mg/1 N 20181231 0536-1041_e447723b-6d4c-484a-8674-273e078e771b 0536-1041 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA078317 Rugby Laboratories CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 0536-1044_bc89d087-683c-4c9d-b1b5-220a46912e34 0536-1044 HUMAN OTC DRUG Rugby Congestion Relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20141006 ANDA ANDA203200 Rugby Laboratories IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20181231 0536-1045_54fcd3ed-3334-4231-9d0e-ef623b4da257 0536-1045 HUMAN OTC DRUG Sore Throat and Cough benzocaine and dextromethorphan hydrobromide LOZENGE ORAL 20141104 OTC MONOGRAPH NOT FINAL part356 Rugby Laboratories BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20181231 0536-1046_60df26bc-5968-5d60-e053-2a91aa0a37d7 0536-1046 HUMAN OTC DRUG Sodium Bicarbonate Antacid Sodium Bicarbonate TABLET ORAL 20150325 OTC MONOGRAPH FINAL part331 Rugby Laboratories SODIUM BICARBONATE 325 mg/1 N 20181231 0536-1047_60df5791-6a2b-d303-e053-2a91aa0adff9 0536-1047 HUMAN OTC DRUG Sodium Bicarbonate Antacid Sodium Bicarbonate TABLET ORAL 20150325 OTC MONOGRAPH FINAL part331 Rugby Laboratories SODIUM BICARBONATE 650 mg/1 N 20181231 0536-1048_af05054d-cbc8-4268-b9a5-038ad3d05f1f 0536-1048 HUMAN OTC DRUG Rugby Antacid Tablets TABLET, CHEWABLE ORAL 20121224 OTC MONOGRAPH FINAL part331 Rugby Laboratories CALCIUM CARBONATE 500 mg/1 N 20181231 0536-1049_d546c63b-64f4-48b5-b790-5c3f73e5f903 0536-1049 HUMAN OTC DRUG calcium antacidextra strength extra strength Calcium carbonate TABLET, CHEWABLE ORAL 20150315 OTC MONOGRAPH FINAL part331 Rugby Laboratories CALCIUM CARBONATE 750 mg/1 N 20181231 0536-1050_b0fcfd66-276e-4741-9aee-915b6364f25c 0536-1050 HUMAN OTC DRUG Rugby Extra Strength Assorted Berries Antacid Tablets TABLET, CHEWABLE ORAL 20150123 OTC MONOGRAPH FINAL part331 Rugby Laboratories CALCIUM CARBONATE 500 mg/1 N 20181231 0536-1052_2f00b967-a04c-4ff4-bd41-20c688023dd5 0536-1052 HUMAN OTC DRUG PEG 3350 POLYETHYLENE GLYCOL 3350 POWDER ORAL 20150105 ANDA ANDA091077 Rugby Laboratories POLYETHYLENE GLYCOL 3350 17 g/17g E 20171231 0536-1053_8f86c3a7-4292-47b3-8ee6-884844bf0324 0536-1053 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH NOT FINAL part343 Rugby Laboratories ASPIRIN 325 mg/1 N 20181231 0536-1054_7143e0b1-f31d-4ac1-8b4f-ef4f21b93554 0536-1054 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 Rugby Laboratories ASPIRIN 325 mg/1 N 20181231 0536-1055_61951e7e-f7c1-4b3e-98b0-cf16e02f09c2 0536-1055 HUMAN OTC DRUG Rugby Benzoyl Peroxide Acne Medication Benzoyl Peroxide GEL TOPICAL 20150120 OTC MONOGRAPH FINAL part333D Rugby Laboratories, Inc. BENZOYL PEROXIDE 50 mg/mL N 20181231 0536-1056_69186872-f969-434c-b3bb-7f4c61f9a784 0536-1056 HUMAN OTC DRUG Rugby Benzoyl Peroxide Acne Medication Benzoyl Peroxide GEL TOPICAL 20150120 OTC MONOGRAPH FINAL part333D Rugby Laboratories, Inc. BENZOYL PEROXIDE 100 mg/mL N 20181231 0536-1057_397656dc-498d-4c57-a17e-54fa7a951e6c 0536-1057 HUMAN OTC DRUG Rugby Benzoyl Peroxide Acne Medication Benzoyl Peroxide LOTION TOPICAL 20150120 OTC MONOGRAPH FINAL part333D Rugby Laboratories, Inc. BENZOYL PEROXIDE 50 mg/mL N 20181231 0536-1058_4c7d0f25-959a-4ab8-822f-bdb6a2fba05e 0536-1058 HUMAN OTC DRUG Rugby Benzoyl Peroxide Acne Medication Benzoyl Peroxide LOTION TOPICAL 20150120 OTC MONOGRAPH FINAL part333D Rugby Laboratories, Inc. BENZOYL PEROXIDE 100 mg/mL N 20181231 0536-1061_8699d1e9-49e0-441e-9eaa-3946e5830b8a 0536-1061 HUMAN OTC DRUG Rugby Ice Blue External Analgesic MENTHOL GEL TOPICAL 20150120 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories, Inc. MENTHOL 20 mg/mL N 20181231 0536-1062_bd69e937-328a-410d-8811-1cb09f143883 0536-1062 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 0536-1064_2cb4460f-a863-4066-9f9b-dab6919b8c70 0536-1064 HUMAN OTC DRUG Stool Softener Extra Strength Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc. DOCUSATE SODIUM 250 mg/1 N 20181231 0536-1065_3ae543b2-47a3-43df-abf3-9e7d4a85ebd6 0536-1065 HUMAN OTC DRUG Stool Softener Docusate calcium CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc. DOCUSATE CALCIUM 240 mg/1 N 20181231 0536-1066_e87e0753-3902-4a46-9aa1-515d75965396 0536-1066 HUMAN OTC DRUG rugby fexofenadine hydrochloride fexofenadine hcl TABLET, FILM COATED ORAL 20150128 ANDA ANDA076447 Rugby Laboratories FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 0536-1068_44b09f98-f793-4e19-9afb-beccc4c3bd27 0536-1068 HUMAN OTC DRUG Robafen Cough Non-Drowsy Formula Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Rugby Laboratories DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 0536-1069_5fa240c5-0a1c-45a9-e053-2a91aa0a4ae8 0536-1069 HUMAN OTC DRUG RUGBY HYDROSKIN HYDROCORTISONE CREAM TOPICAL 20150715 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories HYDROCORTISONE 1 g/100g N 20181231 0536-1079_5f8d08bd-140b-5416-e053-2a91aa0a3a35 0536-1079 HUMAN OTC DRUG HydroSKIN HYDROCORTISONE LOTION TOPICAL 20150825 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories HYDROCORTISONE 1 g/100mL N 20181231 0536-1081_58dcda5f-699a-4757-8d2a-8cde7e90ff7f 0536-1081 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20150915 20180531 ANDA ANDA074916 Rugby Laboratories IBUPROFEN 100 mg/5mL N 20181231 0536-1082_eaa8b361-8c0a-4118-b7b8-1e0a73eb89e2 0536-1082 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 20180430 ANDA ANDA074916 Rugby Laboratories IBUPROFEN 100 mg/5mL N 20181231 0536-1083_3ba51301-d13b-4014-bdb7-45d401a10a8e 0536-1083 HUMAN OTC DRUG Rugby Eye Irrigating Purified Water SOLUTION/ DROPS OPHTHALMIC 20150904 OTC MONOGRAPH FINAL part349 Rugby Laboratories, Inc. WATER 99.05 mL/100mL E 20171231 0536-1084_409478ce-c85e-4ab9-aa0e-77222f4ff15c 0536-1084 HUMAN OTC DRUG Rugby Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20150910 OTC MONOGRAPH FINAL part349 Rugby Laboratories, Inc. POLYVINYL ALCOHOL 14 mg/mL N 20181231 0536-1086_f47615b2-ea66-415c-a161-4b9366efff1b 0536-1086 HUMAN OTC DRUG Rugby Artificial Tears Mineral oil and White petrolatum OINTMENT OPHTHALMIC 20150910 OTC MONOGRAPH FINAL part349 Rugby Laboratories, Inc. MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g N 20181231 0536-1087_5a1a6634-dee0-4c8e-a012-f4b2a500aa38 0536-1087 HUMAN OTC DRUG Rugby Natures Tears Dextran 70 and Hypromellose 2910 SOLUTION/ DROPS OPHTHALMIC 20150910 OTC MONOGRAPH FINAL part349 Rugby Laboratories, Inc. DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) 1; 3 mg/mL; mg/mL N 20181231 0536-1088_a760bdd0-2095-4b30-8c5c-71d83946780b 0536-1088 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Rugby Laboratories IBUPROFEN 200 mg/1 N 20181231 0536-1089_5eb85eac-5703-4c3b-bcb6-df9469c6a870 0536-1089 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Rugby Laboratories IBUPROFEN 200 mg/1 N 20181231 0536-1091_167be802-2477-a159-0db7-75cc766492b2 0536-1091 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160229 ANDA ANDA208150 Rugby Laboratories FLUTICASONE PROPIONATE 50 ug/1 N 20181231 0536-1092_5021e4eb-3ff7-b6a1-0ed2-68ad43462ac7 0536-1092 HUMAN OTC DRUG LORATADINE Loratadine TABLET ORAL 20160622 ANDA ANDA076471 Rugby Laboratories LORATADINE 10 mg/1 N 20181231 0536-1093_16e107f0-45a3-428f-b849-0f20a848a602 0536-1093 HUMAN OTC DRUG Rugby All Day Relief Naproxen Sodium TABLET, FILM COATED ORAL 20150902 ANDA ANDA074661 Rugby Laboratories NAPROXEN SODIUM 220 mg/1 N 20181231 0536-1094_f587a428-291c-4c54-80fe-244a961b0521 0536-1094 HUMAN OTC DRUG rugby all day relief Naproxen Sodium TABLET ORAL 20150902 ANDA ANDA074661 Rugby Laboratories NAPROXEN SODIUM 220 mg/1 N 20181231 0536-1095_0d5e390d-d5e0-45ab-a48d-31c321b5b151 0536-1095 HUMAN OTC DRUG Rugby Cough Syrup Guaifenesin Guaifenesin LIQUID ORAL 20160420 OTC MONOGRAPH FINAL part341 Rugby Laboratories GUAIFENESIN 200 mg/10mL N 20181231 0536-1096_1fc31d3d-b50a-4698-83e1-2689dbeb652b 0536-1096 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20160120 ANDA ANDA077958 Rugby Laboratories KETOTIFEN FUMARATE .35 mg/mL N 20181231 0536-1099_45c0178f-6881-4807-abc3-fd973c934fac 0536-1099 HUMAN OTC DRUG Rugby Lubricant Eye Polyethylene Glycol 400, and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20160427 OTC MONOGRAPH FINAL part349 Rugby Laboratories POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 0536-1101_0ed9e187-3b77-410e-b713-9e68f5c943b1 0536-1101 HUMAN OTC DRUG Rugby Pain Relieving Analgesic Menthol, Unspecified Form and Methyl Salicylate CREAM TOPICAL 20160511 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 10; 150 mg/mL; mg/mL N 20181231 0536-1102_47a39009-90c5-5a35-e054-00144ff8d46c 0536-1102 HUMAN OTC DRUG Rugby Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% LIQUID TOPICAL 20160701 NDA NDA019125 Rugby Laboratories CHLORHEXIDINE GLUCONATE 2 g/100mL N 20181231 0536-1104_7ad08586-cf67-4500-ab3b-93a544f4c788 0536-1104 HUMAN OTC DRUG Rugby Ultra Lubricant Eye Polyethylene Glycol 400, and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20160427 OTC MONOGRAPH FINAL part349 Rugby Laboratories POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 0536-1106_8406f632-bcb6-c401-3673-9d12bfa45cd1 0536-1106 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20160401 NDA NDA020076 Rugby Laboratories NICOTINE 7 mg/24h N 20181231 0536-1107_8406f632-bcb6-c401-3673-9d12bfa45cd1 0536-1107 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20160401 NDA NDA020076 Rugby Laboratories NICOTINE 14 mg/24h N 20181231 0536-1108_8406f632-bcb6-c401-3673-9d12bfa45cd1 0536-1108 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20160401 NDA NDA020076 Rugby Laboratories NICOTINE 21 mg/24h N 20181231 0536-1111_68b095c7-7e74-4a6f-bbb0-5ed24488f7e2 0536-1111 HUMAN OTC DRUG Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20160430 OTC MONOGRAPH NOT FINAL part343 Rugby Laboratories, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 0536-1112_57d22727-323a-34c8-09ba-5cf74b7be037 0536-1112 HUMAN OTC DRUG Budesonide Budesonide SPRAY, METERED NASAL 20160713 ANDA ANDA078949 Rugby Laboratories BUDESONIDE 32 ug/1 N 20181231 0536-1117_514d300d-b329-495e-991e-7c0c4b164443 0536-1117 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Rugby Laboratories, Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 0536-1118_c2e43f36-46f6-4947-8ef1-00919f706979 0536-1118 HUMAN OTC DRUG Rugby Arthritis Pain Relieving Topical Analgesic Capsaicin CREAM TOPICAL 20170524 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories CAPSAICIN .75 mg/g N 20181231 0536-1121_52684dc0-ae29-743a-e054-00144ff88e88 0536-1121 HUMAN OTC DRUG Rugby Cooling Pain MENTHOL GEL TOPICAL 20170610 OTC MONOGRAPH NOT FINAL part348 RUGBY LABORATORIES MENTHOL 40 mg/mL N 20181231 0536-1124_64f382b8-7002-4c3b-9021-7672db060ea3 0536-1124 HUMAN OTC DRUG Earwax Treatment Drops Rugby Carbamide Peroxide 6.5% LIQUID AURICULAR (OTIC) 20170201 OTC MONOGRAPH FINAL part344 Rugby Laboratories CARBAMIDE PEROXIDE 6.5 g/100mL N 20181231 0536-1126_5641250e-cf31-6a42-e054-00144ff8d46c 0536-1126 HUMAN OTC DRUG Eye Irrigating purified water SOLUTION OPHTHALMIC 20170501 OTC MONOGRAPH FINAL part349 Rugby Laboratories WATER 99.05 mL/100mL N 20181231 0536-1131_6f51d889-398f-4bc4-a288-369c6ce48595 0536-1131 HUMAN OTC DRUG rugby esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170831 ANDA ANDA207193 Rugby Laboratories ESOMEPRAZOLE 20 mg/1 N 20181231 0536-1134_bbac48c4-ed9c-4713-ae82-def7e66d1316 0536-1134 HUMAN OTC DRUG Miconazole Nitrate MICONAZOLE NITRATE CREAM TOPICAL 19911001 OTC MONOGRAPH FINAL part333C Rugby Laboratories, Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 0536-1275_81ce24a5-b01f-435a-bf9a-b3df2cb24d60 0536-1275 HUMAN OTC DRUG Senexon Standardized Senna Concentrate LIQUID ORAL 20121023 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories SENNOSIDES 8.8 mg/5mL E 20171231 0536-1355_47bfcafb-ac36-40d4-bba9-be40948977da 0536-1355 HUMAN OTC DRUG Biscolax Bisacodyl SUPPOSITORY RECTAL 20020903 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc. BISACODYL 10 mg/1 N 20181231 0536-1362_947d2d77-2b64-4ae5-801c-2cbec5346c58 0536-1362 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20040729 ANDA ANDA076569 Rugby Laboratories NICOTINE 2 mg/1 N 20181231 0536-1372_947d2d77-2b64-4ae5-801c-2cbec5346c58 0536-1372 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20040729 ANDA ANDA076568 Rugby Laboratories NICOTINE 4 mg/1 N 20181231 0536-1389_77915433-713a-46c6-a220-d63aca2a248c 0536-1389 HUMAN OTC DRUG Rugby Hemorrhoidal Phenylephrine Hydrochloride and Fat, Hard SUPPOSITORY RECTAL 20010423 OTC MONOGRAPH FINAL part346 Rugby Laboratories PHENYLEPHRINE HYDROCHLORIDE; FAT, HARD .00525; 1.86 g/1; g/1 N 20181231 0536-1500_60c7ea7a-59ef-5feb-e053-2991aa0a698e 0536-1500 HUMAN OTC DRUG Reguloid Psyllium CAPSULE ORAL 20100428 20191130 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories PSYLLIUM HUSK .52 g/1 N 20181231 0536-1810_306a6ce0-995e-4731-be24-213447448d1f 0536-1810 HUMAN OTC DRUG PINK BISMUTH bismuth subsalicylate LIQUID ORAL 20120401 OTC MONOGRAPH FINAL part335 Rugby Laboratories, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 0536-1850_4cbbd522-2d99-4834-afcf-8d428dcafb82 0536-1850 HUMAN OTC DRUG Rugby Nasal Decongestant Pseudoephedrine Hydrochloride LIQUID ORAL 19990726 OTC MONOGRAPH FINAL part341 Rugby Laboratories, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5mL N 20181231 0536-1875_60df7601-4cc7-f562-e053-2a91aa0a51f7 0536-1875 HUMAN OTC DRUG Reguloid Psyllium Husks POWDER, FOR SOLUTION ORAL 20090612 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories PSYLLIUM HUSK 3.4 g/5.8g N 20181231 0536-1881_60df6c4d-fc11-eb49-e053-2a91aa0a61a2 0536-1881 HUMAN OTC DRUG Reguloid Psyllium POWDER, FOR SOLUTION ORAL 20121029 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories PSYLLIUM HUSK 3.4 g/5g N 20181231 0536-1945_60ccbdf2-9419-3f1e-e053-2a91aa0ac993 0536-1945 HUMAN OTC DRUG RULOX REGULAR aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110105 OTC MONOGRAPH FINAL part331 RUGBY LABORATORIES ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 0536-1962_8555f7dc-82d1-49c1-b68a-69cde8b12b55 0536-1962 HUMAN OTC DRUG Sebex Salicylic Acid, Colloidal Sulfur SHAMPOO TOPICAL 20121029 OTC MONOGRAPH FINAL part333D Rugby Laboratories SALICYLIC ACID; SULFUR 20; 20 mg/1000mL; mg/1000mL N 20181231 0536-1970_f748f053-ba30-4b5b-acb8-e7d81e72c43e 0536-1970 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 Rugby Laboratories Inc. POLYVINYL ALCOHOL 14 mg/mL E 20171231 0536-1995_7dc73cf8-3e47-4b91-8b05-f9ce4a2dd460 0536-1995 HUMAN OTC DRUG Rugby Anti-Dandruff Selenium Sulfide SHAMPOO TOPICAL 20120501 OTC MONOGRAPH FINAL part358H Rugby Laboratories, Inc. SELENIUM SULFIDE 10 mg/mL N 20181231 0536-2220_5e0aed4e-5cd9-1214-e053-2991aa0a09fa 0536-2220 HUMAN OTC DRUG GAS RELIEF Simethicone SUSPENSION/ DROPS ORAL 20101201 OTC MONOGRAPH FINAL part332 Rugby Laboratories DIMETHICONE 20 mg/.3mL N 20181231 0536-2302_a4e2f2f5-533e-4bc5-87ba-80838d193bd5 0536-2302 HUMAN OTC DRUG Blue Gel Pain Relieving Menthol GEL TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories MENTHOL .02 g/g E 20171231 0536-2310_4cd3127a-237a-4ae6-b10f-a0b19da13328 0536-2310 HUMAN OTC DRUG Kidkare cough/cold Chlorpheniramine, Dextromethorphan Hydrobromide, and Pseudoephedrine Hydrochloride LIQUID ORAL 20110113 OTC MONOGRAPH FINAL part341 Rugby Laboratories, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 5; 15 mg/5mL; mg/5mL; mg/5mL N 20181231 0536-2470_5e0833f4-00cd-13de-e053-2a91aa0a577f 0536-2470 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20110128 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0536-2525_9baba6ad-a694-4cf3-b86e-65bffa7d460b 0536-2525 HUMAN OTC DRUG Rugby Capsaicin External Analgesic Capsaicin CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories, Inc. CAPSAICIN .025 g/100g N 20191231 0536-3000_a5201162-9f58-4d51-8318-68ffd474d961 0536-3000 HUMAN OTC DRUG Ear Wax Treatment Carbamide Peroxide SOLUTION/ DROPS AURICULAR (OTIC) 20091026 OTC MONOGRAPH FINAL part344 Rugby Laboratories Inc. CARBAMIDE PEROXIDE 81.86 mg/mL E 20171231 0536-3029_0de78685-6e47-47f3-bcea-e7d492bfa5cc 0536-3029 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Original Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 19990315 ANDA ANDA074507 Rugby Laboratories NICOTINE 2 mg/1 N 20181231 0536-3030_0de78685-6e47-47f3-bcea-e7d492bfa5cc 0536-3030 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Original Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 19990319 ANDA ANDA074707 Rugby Laboratories NICOTINE 4 mg/1 N 20181231 0536-3086_1f9f38c5-31bd-4254-8fbe-6bd1d5f4a9b5 0536-3086 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20080428 OTC MONOGRAPH FINAL part343 Rugby Laboratories Inc. ASPIRIN 81 mg/1 N 20181231 0536-3112_e3bb0c42-05ed-48cd-bb85-3f66129dbf50 0536-3112 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Coated Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20081229 ANDA ANDA078699 Rugby Laboratories NICOTINE 2 mg/1 N 20181231 0536-3113_e3bb0c42-05ed-48cd-bb85-3f66129dbf50 0536-3113 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Coated Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20081229 ANDA ANDA078697 Rugby Laboratories NICOTINE 4 mg/1 N 20181231 0536-3218_45fd7284-bf06-30c3-e054-00144ff88e88 0536-3218 HUMAN OTC DRUG Pain and Fever ACETAMINOPHEN TABLET, COATED ORAL 20110223 OTC MONOGRAPH NOT FINAL part343 RUGBY LABORATORIES ACETAMINOPHEN 500 mg/1 N 20181231 0536-3222_45fd7284-bf19-30c3-e054-00144ff88e88 0536-3222 HUMAN OTC DRUG Pain and Fever ACETAMINOPHEN TABLET ORAL 20110223 OTC MONOGRAPH NOT FINAL part343 RUGBY LABORATORIES ACETAMINOPHEN 325 mg/1 N 20181231 0536-3231_45fd7ae4-d88c-34bc-e054-00144ff8d46c 0536-3231 HUMAN OTC DRUG Pain and Fever ACETAMINOPHEN TABLET ORAL 20110223 OTC MONOGRAPH NOT FINAL part343 RUGBY LABORATORIES ACETAMINOPHEN 500 mg/1 N 20181231 0536-3233_e27f3e6e-9692-4775-b5d9-fc686919af50 0536-3233 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20020812 OTC MONOGRAPH FINAL part343 Rugby Laboratories Inc. ACETAMINOPHEN 80 mg/1 N 20181231 0536-3297_cb1c37d3-f4a3-4733-bb24-63c835f0c940 0536-3297 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19980123 OTC MONOGRAPH FINAL part343 Rugby Laboratories Inc. ASPIRIN 81 mg/1 N 20181231 0536-3305_d23ea51a-b3ca-432a-b060-33f96a570488 0536-3305 HUMAN OTC DRUG Micro-Coated Aspirin Aspirin TABLET, COATED ORAL 20110921 OTC MONOGRAPH FINAL part343 Rugby Laboratories, Inc ASPIRIN 325 mg/1 N 20181231 0536-3313_92e6edd3-1afe-4223-a2a8-fd538088c718 0536-3313 HUMAN OTC DRUG Enteric Coated Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20110920 OTC MONOGRAPH FINAL part343 Rugby Laboratories, Inc ASPIRIN 325 mg/1 N 20181231 0536-3381_28a65991-a53d-4e04-8253-9a9d0c49bf57 0536-3381 HUMAN OTC DRUG Enteric Coated Stimulant Laxative Bisacodyl TABLET, DELAYED RELEASE ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc BISACODYL 5 mg/1 N 20181231 0536-3386_2c28291c-e389-46af-b788-e9464120895d 0536-3386 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20090708 ANDA ANDA079044 Rugby Laboratories NICOTINE 2 mg/1 N 20181231 0536-3387_2c28291c-e389-46af-b788-e9464120895d 0536-3387 HUMAN OTC DRUG Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20090708 ANDA ANDA079038 Rugby Laboratories NICOTINE 4 mg/1 N 20181231 0536-3404_9ce0c9b3-ff77-4669-94cf-91c729f799ee 0536-3404 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING BUCCAL 20090708 ANDA ANDA079216 Rugby Laboratories NICOTINE 2 mg/1 N 20191231 0536-3405_9ce0c9b3-ff77-4669-94cf-91c729f799ee 0536-3405 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING BUCCAL 20090708 ANDA ANDA079219 Rugby Laboratories NICOTINE 4 mg/1 N 20191231 0536-3414_072d6298-0d2b-476e-bb53-eee6dac12127 0536-3414 HUMAN OTC DRUG Calcium carbonate Calcium carbonate TABLET ORAL 19990412 OTC MONOGRAPH FINAL part331 Rugby Laboratories Inc. CALCIUM CARBONATE 648 mg/1 N 20181231 0536-3467_8000b4af-e604-4aa5-b62a-66c902a934ad 0536-3467 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20000530 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 0536-3479_74cea4c6-8712-428c-96af-dd9d85c77962 0536-3479 HUMAN OTC DRUG Acetaminophen and Diphenhydramine HCl Acetaminophen and Diphenhydramine HCl TABLET ORAL 20101006 OTC MONOGRAPH FINAL part343 Rugby Laboratories Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0536-3504_9830a852-c0a7-4ac9-9848-4cf86dd07013 0536-3504 HUMAN OTC DRUG Almacone Aluminum hydroxide, Magnesium hydroxide, Simethicone TABLET, CHEWABLE ORAL 20100823 OTC MONOGRAPH FINAL part332 Rugby Laboratories, Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/1; mg/1; mg/1 E 20171231 0536-3587_3cb379dd-b4d5-4f2f-9da9-c11979317cd3 0536-3587 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110301 ANDA ANDA079174 Rugby Laboratories Inc IBUPROFEN 200 mg/1 N 20181231 0536-3594_b77e622c-70c1-4360-b360-8aca012cd838 0536-3594 HUMAN OTC DRUG Diphenhist Diphenhydramine HCl CAPSULE ORAL 20060530 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0536-3597_f95ca994-1117-4c92-adf1-3f6825d7bf5f 0536-3597 HUMAN OTC DRUG Diphenhist Diphenhydramine HCl TABLET ORAL 20060926 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0536-3603_a9e31638-7a95-4173-b204-daed7aa0f700 0536-3603 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20120326 ANDA ANDA078682 Rugby Laboratories, Inc. IBUPROFEN 200 mg/1 N 20181231 0536-3604_788872f2-1673-42b3-bc0d-ece417bbe721 0536-3604 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20120509 OTC MONOGRAPH FINAL part332 Rugby Laboratories, Inc. DIMETHICONE 180 mg/1 N 20181231 0536-3605_411070bc-dca5-4c0a-a574-7d098c0cbefd 0536-3605 HUMAN OTC DRUG Acetaminophen and Diphenhydramine HCl Acetagesic TABLET ORAL 20120612 OTC MONOGRAPH FINAL part343 Rugby Laboratories Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN 12.5; 325 mg/1; mg/1 N 20181231 0536-3606_94679ccd-44e7-4903-841d-fdc9e998fa26 0536-3606 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen Acetaminophen SUSPENSION ORAL 20160316 OTC MONOGRAPH NOT FINAL part343 Rugby ACETAMINOPHEN 160 mg/5mL E 20171231 0536-3607_60df683a-1511-0e24-e053-2991aa0adb13 0536-3607 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET ORAL 20121029 OTC MONOGRAPH FINAL part341 Rugby Laboratories PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 0536-3755_7f7f83e2-b04d-44d0-84cb-f2a85cac8e35 0536-3755 HUMAN OTC DRUG Stool Softener DC Laxative DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20111201 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories Inc DOCUSATE CALCIUM 240 mg/1 N 20181231 0536-3756_ab17427e-4079-4c76-91f9-53af9b508b7e 0536-3756 HUMAN OTC DRUG Non-Habit Forming Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories Inc DOCUSATE SODIUM 100 mg/1 N 20181231 0536-3757_291d6bae-4c24-4ead-b075-0a671f905ed4 0536-3757 HUMAN OTC DRUG EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories Inc DOCUSATE SODIUM 250 mg/1 N 20181231 0536-3772_08ece8f0-64f9-4738-9423-2e7b2ca420ee 0536-3772 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl TABLET ORAL 20070713 OTC MONOGRAPH FINAL part341 Rugby Laboratories Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 0536-3985_746b935f-de20-4070-af96-aacc71f44079 0536-3985 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20060714 OTC MONOGRAPH FINAL part336 Rugby Laboratories Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 0536-3990_c500c05e-d501-4e0a-b01d-c0223ae05191 0536-3990 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20080722 OTC MONOGRAPH FINAL part336 Rugby Laboratories Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 0536-4086_e6f3e8a2-567b-495f-832a-c7c8ae1f7ba9 0536-4086 HUMAN OTC DRUG SENEXON-S DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20110316 OTC MONOGRAPH NOT FINAL part334 RUGBY LABORATORIES, INC. DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 N 20181231 0536-4088_71c2d2d8-9c05-4b2a-826a-25d6300a9fd8 0536-4088 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine hydrochloride TABLET ORAL 20120323 ANDA ANDA078780 Rugby Laboratories, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0536-4089_f3c1bcd1-625f-4a8f-807e-9d46edd216b0 0536-4089 HUMAN OTC DRUG Acne Medication 5 Benzoyl Peroxide GEL TOPICAL 20121029 OTC MONOGRAPH FINAL part333D Rugby Laboratories BENZOYL PEROXIDE 50 mg/g E 20171231 0536-4092_03b94e6c-f864-48ad-94c1-f08ddc2c2de0 0536-4092 HUMAN OTC DRUG Acne Medication 10 Benzoyl Peroxide GEL TOPICAL 20121029 OTC MONOGRAPH FINAL part333D Rugby Laboratories BENZOYL PEROXIDE 100 mg/g E 20171231 0536-4113_2d53fc65-83b2-4cc0-aa31-1b35bd26ea62 0536-4113 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20091125 ANDA ANDA079096 Rugby Laboratories Inc NAPROXEN SODIUM 220 mg/1 N 20181231 0536-4301_22b0e4d5-985d-4ba4-a028-9883c069d01f 0536-4301 HUMAN OTC DRUG Bismuth subsalicylate Bismuth subsalicylate TABLET ORAL 19960123 OTC MONOGRAPH FINAL part335 Rugby Laboratories Inc. BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 0536-4306_e691924b-76e8-4339-8f2e-faa2caf14e47 0536-4306 HUMAN OTC DRUG Fiber Lax Calcium Polycarbophil TABLET, FILM COATED ORAL 20100901 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 0536-4391_26ba1486-871c-47fa-9790-328a9d3bdf5d 0536-4391 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, SUGAR COATED ORAL 20110922 OTC MONOGRAPH FINAL part341 Rugby Laboratories, Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 0536-4444_60df7601-4cd6-f562-e053-2a91aa0a51f7 0536-4444 HUMAN OTC DRUG Reguloid Psyllium POWDER, FOR SOLUTION ORAL 20090622 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories PSYLLIUM HUSK 3.4 g/7g N 20181231 0536-4445_60df7601-4ce5-f562-e053-2a91aa0a51f7 0536-4445 HUMAN OTC DRUG Reguloid Psyllium POWDER, FOR SOLUTION ORAL 20090622 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories PSYLLIUM HUSK 3.4 g/12g N 20181231 0536-4533_30e4ab62-a058-4dc8-ac41-a45b5c8dc59c 0536-4533 HUMAN OTC DRUG Gas Relief Simethicone TABLET, CHEWABLE ORAL 19950101 OTC MONOGRAPH FINAL part332 Rugby Laboratories Inc. DIMETHICONE 80 mg/1 N 20181231 0536-4534_e76fb40a-e9df-4267-9529-635516390eb7 0536-4534 HUMAN OTC DRUG Gas Relief Simethicone TABLET, CHEWABLE ORAL 19951016 OTC MONOGRAPH FINAL part332 Rugby Laboratories Inc. DIMETHICONE 125 mg/1 N 20181231 0536-4540_2f621fcf-b08c-4e0a-8a15-11a1894d7b1f 0536-4540 HUMAN OTC DRUG Sodium Bicarbonate Sodium Bicarbonate TABLET ORAL 20100421 OTC MONOGRAPH FINAL part331 Rugby Laboratories, Inc. SODIUM BICARBONATE 325 mg/1 E 20171231 0536-4544_d8850588-2337-462e-bc3b-c94d82792284 0536-4544 HUMAN OTC DRUG Sodium Bicarbonate Sodium Bicarbonate TABLET ORAL 20100308 OTC MONOGRAPH FINAL part331 Rugby Laboratories, Inc. SODIUM BICARBONATE 650 mg/1 E 20171231 0536-4742_654ee499-29b8-464e-8190-459cf75d25ab 0536-4742 HUMAN OTC DRUG Calgest Calgest TABLET ORAL 19960123 OTC MONOGRAPH FINAL part331 Rugby Laboratories Inc. CALCIUM CARBONATE 500 mg/1 N 20181231 0536-5005_bad09514-ea1b-4d6d-8489-8898136037ce 0536-5005 HUMAN OTC DRUG Nasal Relief 12-Hour Oxymetazoline Hydrochloride SPRAY NASAL 20121029 OTC MONOGRAPH FINAL part341 Rugby Laboratories OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL E 20171231 0536-5105_b92989a1-d34d-46cf-bb22-1ac92bd209b5 0536-5105 HUMAN OTC DRUG Hydro Skin HYDROCORTISONE LOTION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories HYDROCORTISONE 1 g/mL E 20171231 0536-5108_3143369a-e265-4bf0-86c4-5e2b43f75b85 0536-5108 HUMAN OTC DRUG HydroSkin Hydrocortisone CREAM TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part348 Rugby Laboratories HYDROCORTISONE 1 g/100g E 20171231 0536-5150_5df792df-f5bf-3e0a-e053-2a91aa0a1320 0536-5150 HUMAN OTC DRUG Anti-Fungal TOLNAFTATE POWDER TOPICAL 20111101 OTC MONOGRAPH FINAL part333C Rugby Laboratories TOLNAFTATE 1 g/100g N 20181231 0536-5700_01586357-6c74-4180-96a4-9a78840f6f2f 0536-5700 HUMAN OTC DRUG Rugby Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20040323 OTC MONOGRAPH FINAL part347 Rugby Laboratories ZINC OXIDE 200 mg/g N 20181231 0536-5894_25ce29cf-b8df-8197-b02c-6990ec6b43ff 0536-5894 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 19971020 ANDA ANDA074612 Rugby Laboratories NICOTINE 7 mg/24h N 20181231 0536-5895_25ce29cf-b8df-8197-b02c-6990ec6b43ff 0536-5895 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 19971020 ANDA ANDA074612 Rugby Laboratories NICOTINE 14 mg/24h N 20181231 0536-5896_25ce29cf-b8df-8197-b02c-6990ec6b43ff 0536-5896 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 19971020 ANDA ANDA074612 Rugby Laboratories NICOTINE 21 mg/24h N 20181231 0536-5904_186d75c7-7b10-464d-a94d-f48d12db4c0b 0536-5904 HUMAN OTC DRUG SENEXON SENNA TABLET, COATED ORAL 20060209 OTC MONOGRAPH NOT FINAL part334 RUGBY LABORATORIES, INC. SENNOSIDES A AND B 8.6 mg/1 N 20181231 0536-6237_3bb70d72-f763-4486-8f6a-d37ece21292b 0536-6237 HUMAN OTC DRUG Natures Tears Hypromellose SOLUTION/ DROPS OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 Rugby Laboratories Inc. HYPROMELLOSE 2910 (3 MPA.S) 4 mg/mL E 20171231 0536-6550_71876336-83de-4baa-a82d-4b056b41bbeb 0536-6550 HUMAN OTC DRUG Artificial Tears white petrolatum mineral oil OINTMENT OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 Rugby Laboratories Inc. MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g E 20171231 0536-7415_a2797325-b60b-4e79-a866-cf5a710baa28 0536-7415 HUMAN OTC DRUG Ready-to-Use Sodium Phosphate ENEMA RECTAL 20110901 OTC MONOGRAPH NOT FINAL part334 Rugby Laboratories, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL N 20181231 0536-7500_3e0c1ce8-c980-46cd-b817-2a0b9fa86e2a 0536-7500 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20150102 OTC MONOGRAPH NOT FINAL part333A Rugby Laboratories ISOPROPYL ALCOHOL .7 mL/mL E 20171231 0548-5400_41d1fc3e-b61a-46c9-8eb4-a401f6d23ee6 0548-5400 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone acetate INJECTION, SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 20171128 ANDA ANDA077235 Amphastar Pharmaceuticals, Inc. MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20191231 0548-5601_b3c1914d-5633-45a5-a1b1-952a5665ae58 0548-5601 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5602_b3c1914d-5633-45a5-a1b1-952a5665ae58 0548-5602 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5603_b3c1914d-5633-45a5-a1b1-952a5665ae58 0548-5603 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5604_b3c1914d-5633-45a5-a1b1-952a5665ae58 0548-5604 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5605_b3c1914d-5633-45a5-a1b1-952a5665ae58 0548-5605 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5606_b3c1914d-5633-45a5-a1b1-952a5665ae58 0548-5606 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5607_b3c1914d-5633-45a5-a1b1-952a5665ae58 0548-5607 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5631_4233e11f-d190-4096-98c7-fc13d59fd0e2 0548-5631 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5632_4233e11f-d190-4096-98c7-fc13d59fd0e2 0548-5632 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5633_4233e11f-d190-4096-98c7-fc13d59fd0e2 0548-5633 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5634_4233e11f-d190-4096-98c7-fc13d59fd0e2 0548-5634 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5635_4233e11f-d190-4096-98c7-fc13d59fd0e2 0548-5635 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5636_4233e11f-d190-4096-98c7-fc13d59fd0e2 0548-5636 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5637_4233e11f-d190-4096-98c7-fc13d59fd0e2 0548-5637 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin sodium INJECTION SUBCUTANEOUS 20110919 ANDA ANDA076684 Amphastar Pharmaceuticals, Inc. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0548-5701_41d1fc3e-b61a-46c9-8eb4-a401f6d23ee6 0548-5701 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone acetate INJECTION, SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 20171128 ANDA ANDA077334 Amphastar Pharmaceuticals, Inc. MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20191231 0548-5900_2116f568-69bb-4ed8-92ed-bd80ee412946 0548-5900 HUMAN PRESCRIPTION DRUG Cortrosyn Cosyntropin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20030801 NDA NDA016750 Amphastar Pharmaceuticals, Inc. COSYNTROPIN .25 mg/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] N 20181231 0548-9021_75c9126f-500c-48a1-acab-7467d4ce39ef 0548-9021 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION INTRAMUSCULAR; INTRAVENOUS 20160311 ANDA ANDA076209 Amphastar Pharmaceuticals, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0548-9090_9d798dca-17f4-4ab4-9c1e-7d6f4f1bfa40 0548-9090 HUMAN PRESCRIPTION DRUG AMPHADASE hyaluronidase INJECTION SUBCUTANEOUS 20041026 NDA NDA021665 Amphastar Pharmaceuticals, Inc. HYALURONIDASE 150 [USP'U]/mL Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] N 20181231 0548-9401_de280771-8cac-4c03-a8c0-cfdbe3d12a0a 0548-9401 HUMAN PRESCRIPTION DRUG Sodium Nitroprusside Sodium Nitroprusside INJECTION INTRAVENOUS 20171218 ANDA ANDA209832 Amphastar Pharmaceuticals, Inc. SODIUM NITROPRUSSIDE 50 mg/2mL Vasodilation [PE],Vasodilator [EPC] N 20181231 0548-9601_10cdd0ff-353d-4308-99a0-8df8e845d0fb 0548-9601 HUMAN PRESCRIPTION DRUG NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate INJECTION INTRAVENOUS 20170925 ANDA ANDA209933 Amphastar Pharmaceuticals, Inc. NEOSTIGMINE METHYLSULFATE .5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0548-9602_10cdd0ff-353d-4308-99a0-8df8e845d0fb 0548-9602 HUMAN PRESCRIPTION DRUG NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate INJECTION INTRAVENOUS 20170925 ANDA ANDA209933 Amphastar Pharmaceuticals, Inc. NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0555-0033_49e4e213-197e-49ec-9a95-1b5f67a3a623 0555-0033 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19900930 ANDA ANDA083116 Teva Pharmaceuticals USA, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0555-0066_2816cff9-562f-4174-85c6-35e813dc51e2 0555-0066 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080936 Teva Pharmaceuticals USA, Inc. ISONIAZID 100 mg/1 Antimycobacterial [EPC] N 20181231 0555-0071_2816cff9-562f-4174-85c6-35e813dc51e2 0555-0071 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 Teva Pharmaceuticals USA, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 0555-0094_2457e324-f6a7-47cf-bacd-6cc83a4b0d18 0555-0094 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050810 ANDA ANDA077194 Teva Pharmaceuticals USA, Inc CLONAZEPAM .125 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0555-0095_2457e324-f6a7-47cf-bacd-6cc83a4b0d18 0555-0095 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050810 ANDA ANDA077194 Teva Pharmaceuticals USA, Inc CLONAZEPAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0555-0096_2457e324-f6a7-47cf-bacd-6cc83a4b0d18 0555-0096 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050811 ANDA ANDA077194 Teva Pharmaceuticals USA, Inc CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0555-0097_2457e324-f6a7-47cf-bacd-6cc83a4b0d18 0555-0097 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050811 ANDA ANDA077194 Teva Pharmaceuticals USA, Inc CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0555-0098_2457e324-f6a7-47cf-bacd-6cc83a4b0d18 0555-0098 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050811 ANDA ANDA077194 Teva Pharmaceuticals USA, Inc CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0555-0140_86a1c2ed-fde6-483a-802f-386cb134ad40 0555-0140 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20080828 20180331 ANDA ANDA077605 Teva Pharmaceuticals USA, Inc. GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0555-0158_49e4e213-197e-49ec-9a95-1b5f67a3a623 0555-0158 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760701 ANDA ANDA084768 Teva Pharmaceuticals USA, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0555-0159_49e4e213-197e-49ec-9a95-1b5f67a3a623 0555-0159 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760701 ANDA ANDA084769 Teva Pharmaceuticals USA, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0555-0171_227a741e-1fd8-4c53-9f02-42068033ecc5 0555-0171 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride TABLET ORAL 20040106 ANDA ANDA076392 Teva Pharmaceuticals USA, Inc. MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] N 20181231 0555-0211_91cc7e15-8266-4020-a3f0-652dca1cab68 0555-0211 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone Acetate TABLET ORAL 20010629 ANDA ANDA075951 Barr Laboratories Inc. NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0555-0252_57db5607-0284-4439-9844-c8d764de13f9 0555-0252 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 19801001 ANDA ANDA087184 Teva Pharmaceuticals USA, Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0555-0285_57db5607-0284-4439-9844-c8d764de13f9 0555-0285 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 19820101 ANDA ANDA087716 Teva Pharmaceuticals USA, Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0555-0286_57db5607-0284-4439-9844-c8d764de13f9 0555-0286 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 19820101 ANDA ANDA087717 Teva Pharmaceuticals USA, Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0555-0302_75901fb4-c031-446a-9e29-c1e0bf142612 0555-0302 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19840701 ANDA ANDA088487 Teva Pharmaceuticals USA, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0555-0323_75901fb4-c031-446a-9e29-c1e0bf142612 0555-0323 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19840701 ANDA ANDA088496 Teva Pharmaceuticals USA, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0555-0324_75901fb4-c031-446a-9e29-c1e0bf142612 0555-0324 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19840701 ANDA ANDA088488 Teva Pharmaceuticals USA, Inc. HYDROXYZINE PAMOATE 100 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0555-0344_df13aefb-57d1-43e7-8a26-fe0a28081314 0555-0344 HUMAN PRESCRIPTION DRUG Errin Norethindrone TABLET ORAL 20030108 20190331 ANDA ANDA076225 Teva Pharmaceuticals USA, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0555-0381_7aac04b4-4adc-4c05-9892-23c13bf5fdb3 0555-0381 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19970203 ANDA ANDA088639 Teva Pharmaceuticals USA, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0555-0392_7aac04b4-4adc-4c05-9892-23c13bf5fdb3 0555-0392 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 20150224 ANDA ANDA088640 Teva Pharmaceuticals USA, Inc. MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0555-0483_47b3a210-2bb2-4b68-9e8a-4b8bfbede882 0555-0483 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride and Hydrochlorothiazide Amiloride Hydrochloride and Hydrochlorothiazide TABLET ORAL 19891201 ANDA ANDA071111 Teva Pharmaceuticals USA, Inc. AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0555-0484_ad0b4095-d91f-4bb9-be70-78ebbbffc57c 0555-0484 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19900630 ANDA ANDA071198 Teva Pharmaceuticals USA, Inc. LEUCOVORIN CALCIUM 5 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0555-0485_ad0b4095-d91f-4bb9-be70-78ebbbffc57c 0555-0485 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19900630 ANDA ANDA071199 Teva Pharmaceuticals USA, Inc. LEUCOVORIN CALCIUM 25 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0555-0513_09606cfc-6929-4556-8751-94485d57484c 0555-0513 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20000222 NDA AUTHORIZED GENERIC NDA012945 Barr Laboratories Inc. ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 0555-0572_a4b13a9b-832c-4c8b-9338-7105e993e6c7 0555-0572 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate TABLET ORAL 19901101 ANDA ANDA081099 Barr Laboratories Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 0555-0588_9afede1b-4832-4807-8b8d-0533f057987f 0555-0588 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE PELLETS ORAL 20041215 ANDA ANDA077167 Teva Pharmaceuticals USA, Inc. DIDANOSINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0555-0589_9afede1b-4832-4807-8b8d-0533f057987f 0555-0589 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE PELLETS ORAL 20041215 ANDA ANDA077167 Teva Pharmaceuticals USA, Inc. DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0555-0590_9afede1b-4832-4807-8b8d-0533f057987f 0555-0590 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE PELLETS ORAL 20041215 ANDA ANDA077167 Teva Pharmaceuticals USA, Inc. DIDANOSINE 400 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0555-0606_e75922a8-70c6-42a9-b33b-4a64d721fd46 0555-0606 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19961025 ANDA ANDA074621 Teva Pharmaceuticals USA, Inc. MEGESTROL ACETATE 20 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0555-0607_e75922a8-70c6-42a9-b33b-4a64d721fd46 0555-0607 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19951130 ANDA ANDA074621 Teva Pharmaceuticals USA, Inc. MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0555-0633_4eb76ac7-9ce0-43aa-bc8e-06e6b7dafea4 0555-0633 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 19980625 ANDA ANDA074582 Teva Pharmaceuticals USA, Inc. DANAZOL 50 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 0555-0634_4eb76ac7-9ce0-43aa-bc8e-06e6b7dafea4 0555-0634 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 19980625 ANDA ANDA074582 Teva Pharmaceuticals USA, Inc. DANAZOL 100 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 0555-0635_4eb76ac7-9ce0-43aa-bc8e-06e6b7dafea4 0555-0635 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 19960809 ANDA ANDA074582 Teva Pharmaceuticals USA, Inc. DANAZOL 200 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 0555-0701_ff96f87e-f9c0-42a7-b3e4-874fa2ef8792 0555-0701 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20050104 ANDA ANDA065171 Teva Pharmaceuticals USA, Inc. DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0555-0702_ff96f87e-f9c0-42a7-b3e4-874fa2ef8792 0555-0702 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20050104 ANDA ANDA065171 Teva Pharmaceuticals USA, Inc. DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0555-0715_0d404223-5201-44ef-b515-e1705876fde2 0555-0715 HUMAN PRESCRIPTION DRUG Camila Norethindrone TABLET ORAL 20021030 20180228 ANDA ANDA076177 Teva Pharmaceuticals USA, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0555-0733_fc1f4209-93e5-4663-8660-17e008ae3e0f 0555-0733 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19990503 ANDA ANDA071196 Teva Pharmaceuticals USA, Inc.. TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 0555-0775_0ef41c2d-39d2-4434-8710-87cd1b0f63de 0555-0775 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20030319 ANDA ANDA040422 Teva Pharmaceuticals USA, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0776_0ef41c2d-39d2-4434-8710-87cd1b0f63de 0555-0776 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20030319 ANDA ANDA040422 Teva Pharmaceuticals USA, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0777_0ef41c2d-39d2-4434-8710-87cd1b0f63de 0555-0777 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20030319 ANDA ANDA040422 Teva Pharmaceuticals USA, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0779_3b414081-f215-4441-abcf-8e936918c3b4 0555-0779 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Teva Pharmaceuticals USA, Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0555-0787_5f335b95-dc0c-40a5-815a-b8277b80d751 0555-0787 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Barr Laboratories Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0788_5f335b95-dc0c-40a5-815a-b8277b80d751 0555-0788 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Barr Laboratories Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0789_5f335b95-dc0c-40a5-815a-b8277b80d751 0555-0789 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Barr Laboratories Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0790_5f335b95-dc0c-40a5-815a-b8277b80d751 0555-0790 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Barr Laboratories Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0791_5f335b95-dc0c-40a5-815a-b8277b80d751 0555-0791 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Barr Laboratories Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0792_5f335b95-dc0c-40a5-815a-b8277b80d751 0555-0792 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Barr Laboratories Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0808_bfc050ad-9055-4226-b30d-acc79c66fa29 0555-0808 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CAPSULE, LIQUID FILLED ORAL 20070626 ANDA ANDA077684 Barr Laboratories Inc. TRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0555-0834_dec7e276-c012-481a-a426-e2eb277afed3 0555-0834 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0555-0835_dec7e276-c012-481a-a426-e2eb277afed3 0555-0835 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 20180228 ANDA ANDA040145 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0555-0869_dec7e276-c012-481a-a426-e2eb277afed3 0555-0869 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 20180228 ANDA ANDA040145 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0555-0872_3b414081-f215-4441-abcf-8e936918c3b4 0555-0872 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Teva Pharmaceuticals USA, Inc. MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0555-0873_3b414081-f215-4441-abcf-8e936918c3b4 0555-0873 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961203 ANDA ANDA040159 Teva Pharmaceuticals USA, Inc. MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0555-0874_dec7e276-c012-481a-a426-e2eb277afed3 0555-0874 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 20180228 ANDA ANDA040145 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0555-0882_3b9c9ccf-3d3b-4208-89b9-7bdfc6e6b577 0555-0882 HUMAN PRESCRIPTION DRUG HYDROXYUREA Hydroxyurea CAPSULE ORAL 19981019 ANDA ANDA075143 Teva Pharmaceuticals USA Inc HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] N 20181231 0555-0886_573a09ec-a698-4a7f-92f5-e46232af61fd 0555-0886 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Teva Pharmaceuticals USA, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0555-0887_573a09ec-a698-4a7f-92f5-e46232af61fd 0555-0887 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Teva Pharmaceuticals USA, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0555-0899_573a09ec-a698-4a7f-92f5-e46232af61fd 0555-0899 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Teva Pharmaceuticals USA, Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0555-0923_cf48a525-8122-4ec4-bb2f-eebbed4a4707 0555-0923 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20011127 ANDA ANDA076057 Barr Laboratories Inc. ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] N 20181231 0555-0926_dec7e276-c012-481a-a426-e2eb277afed3 0555-0926 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19981116 20180228 ANDA ANDA040145 Teva Pharmaceuticals USA, Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0555-0952_b2762f45-0be8-44e6-ad8e-e645109592af 0555-0952 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate TABLET ORAL 20010212 ANDA ANDA040361 Teva Pharmaceuticals USA, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0953_b2762f45-0be8-44e6-ad8e-e645109592af 0555-0953 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate TABLET ORAL 20010212 ANDA ANDA040361 Teva Pharmaceuticals USA, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0955_a713d3ed-0eb3-4dcc-be8e-d03a954a8d95 0555-0955 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20020226 20180731 ANDA ANDA076137 Teva Pharmaceuticals, USA, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0956_a713d3ed-0eb3-4dcc-be8e-d03a954a8d95 0555-0956 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20020226 20180731 ANDA ANDA076137 Teva Pharmaceuticals, USA, Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0971_0ef41c2d-39d2-4434-8710-87cd1b0f63de 0555-0971 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020211 ANDA ANDA040422 Teva Pharmaceuticals USA, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0972_0ef41c2d-39d2-4434-8710-87cd1b0f63de 0555-0972 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020211 ANDA ANDA040422 Teva Pharmaceuticals USA, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0973_0ef41c2d-39d2-4434-8710-87cd1b0f63de 0555-0973 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020211 ANDA ANDA040422 Teva Pharmaceuticals USA, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0974_0ef41c2d-39d2-4434-8710-87cd1b0f63de 0555-0974 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020211 ANDA ANDA040422 Teva Pharmaceuticals USA, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0555-0997_b61dc31b-5cf1-4fd7-8a8d-4fd6c33a383c 0555-0997 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate Fludrocortisone Acetate TABLET ORAL 20030214 ANDA ANDA040425 Teva Pharmaceuticals USA, Inc. FLUDROCORTISONE ACETATE .1 mg/1 N 20181231 0555-1009_585b8cf0-6b31-4919-8a10-eeef2887bf38 0555-1009 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 20100825 20180430 ANDA ANDA079090 Teva Pharmaceuticals USA, Inc. CLONIDINE .1 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0555-1011_585b8cf0-6b31-4919-8a10-eeef2887bf38 0555-1011 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 20100825 20180331 ANDA ANDA079090 Teva Pharmaceuticals USA, Inc. CLONIDINE .3 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0555-1021_86a1c2ed-fde6-483a-802f-386cb134ad40 0555-1021 HUMAN PRESCRIPTION DRUG Galantamine Galantamine CAPSULE, EXTENDED RELEASE ORAL 20081015 20180531 ANDA ANDA078189 Teva Pharmaceuticals USA, Inc. GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0555-1022_86a1c2ed-fde6-483a-802f-386cb134ad40 0555-1022 HUMAN PRESCRIPTION DRUG Galantamine Galantamine CAPSULE, EXTENDED RELEASE ORAL 20081015 20180531 ANDA ANDA078189 Teva Pharmaceuticals USA, Inc. GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0555-1054_adc9c058-accf-49e6-b5e2-80c3daa2ad72 0555-1054 HUMAN PRESCRIPTION DRUG Claravis Isotretinoin CAPSULE, LIQUID FILLED ORAL 20030509 ANDA ANDA076356 Teva Pharmaceuticals USA, Inc. ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0555-1055_adc9c058-accf-49e6-b5e2-80c3daa2ad72 0555-1055 HUMAN PRESCRIPTION DRUG Claravis Isotretinoin CAPSULE, LIQUID FILLED ORAL 20030509 ANDA ANDA076135 Teva Pharmaceuticals USA, Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0555-1056_adc9c058-accf-49e6-b5e2-80c3daa2ad72 0555-1056 HUMAN PRESCRIPTION DRUG Claravis Isotretinoin CAPSULE, LIQUID FILLED ORAL 20060518 ANDA ANDA076135 Teva Pharmaceuticals USA, Inc. ISOTRETINOIN 30 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0555-1057_adc9c058-accf-49e6-b5e2-80c3daa2ad72 0555-1057 HUMAN PRESCRIPTION DRUG Claravis Isotretinoin CAPSULE, LIQUID FILLED ORAL 20030509 ANDA ANDA076135 Teva Pharmaceuticals USA, Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0555-9008_3029b7f8-3cf5-474a-928c-e6b992af1e0d 0555-9008 HUMAN PRESCRIPTION DRUG Nortrel 28 Day Norethindrone and Ethinyl Estradiol KIT 20010606 ANDA ANDA072695 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9009_3029b7f8-3cf5-474a-928c-e6b992af1e0d 0555-9009 HUMAN PRESCRIPTION DRUG Nortrel 21 Day Norethindrone and Ethinyl Estradiol TABLET ORAL 20010613 ANDA ANDA072693 Teva Pharmaceuticals USA, Inc. NORETHINDRONE; ETHINYL ESTRADIOL 1; .035 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0555-9010_3029b7f8-3cf5-474a-928c-e6b992af1e0d 0555-9010 HUMAN PRESCRIPTION DRUG Nortrel 28 Day Norethindrone and Ethinyl Estradiol KIT 20010606 ANDA ANDA072696 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9012_df204887-5230-4c22-bc67-11691781152a 0555-9012 HUMAN PRESCRIPTION DRUG Nortrel 7/7/7 (28 Day Regimen) Norethindrone and Ethinyl Estradiol KIT 20030102 ANDA ANDA075478 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9014_3efda9e9-bd79-4fc1-9d20-305b613ae48c 0555-9014 HUMAN PRESCRIPTION DRUG Lessina Levonorgestrel and Ethinyl Estradiol KIT 20020422 ANDA ANDA075803 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9016_f6c7ad7f-0d67-42e3-9367-fe91b313ec16 0555-9016 HUMAN PRESCRIPTION DRUG Sprintec Norgestimate and Ethinyl Estradiol KIT 20020926 ANDA ANDA075804 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9018_996150d4-3f11-4bfc-8bf2-53fcdd96f5cd 0555-9018 HUMAN PRESCRIPTION DRUG Tri-Sprintec norgestimate and ethinyl estradiol KIT 20031229 ANDA ANDA075808 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9020_a8242c9e-f06c-480a-a77a-c273d44c06c3 0555-9020 HUMAN PRESCRIPTION DRUG Portia Levonorgestrel and Ethinyl Estradiol KIT 20020627 ANDA ANDA075866 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9025_ce80cf16-82a1-49dc-bdd1-ddd1d10e69c8 0555-9025 HUMAN PRESCRIPTION DRUG Junel 21 Day Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20030918 ANDA ANDA076380 Teva Pharmaceuticals USA, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; 20 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0555-9026_ce80cf16-82a1-49dc-bdd1-ddd1d10e69c8 0555-9026 HUMAN PRESCRIPTION DRUG Junel Fe 28 Day Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20030918 ANDA ANDA076081 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9027_ce80cf16-82a1-49dc-bdd1-ddd1d10e69c8 0555-9027 HUMAN PRESCRIPTION DRUG Junel 21 Day Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20030918 ANDA ANDA076381 Teva Pharmaceuticals USA, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1.5; 30 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0555-9028_ce80cf16-82a1-49dc-bdd1-ddd1d10e69c8 0555-9028 HUMAN PRESCRIPTION DRUG Junel Fe 28 Day Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20030918 ANDA ANDA076064 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9032_31309c3b-236e-40fa-a93d-373323f07cb7 0555-9032 HUMAN PRESCRIPTION DRUG Tri-Legest Fe 28 Day Norethindrone Acetate and Ethinyl Estradiol KIT 20071026 ANDA ANDA076105 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9034_d86fb321-9930-4445-b162-dd225e1871e6 0555-9034 HUMAN PRESCRIPTION DRUG Balziva Norethindrone and Ethinyl Estradiol KIT 20061016 ANDA ANDA076238 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9043_1b519cda-9a4d-4c90-9974-7b06b1fcc4a7 0555-9043 HUMAN PRESCRIPTION DRUG Apri 28 Day Desogestrel and Ethinyl Estradiol KIT 19991022 ANDA ANDA075256 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9045_f4c68be8-e82d-4ecc-aa57-c449976d51d2 0555-9045 HUMAN PRESCRIPTION DRUG Aviane Levonorgestrel and Ethinyl Estradiol KIT 20010402 ANDA ANDA075796 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9047_61009853-39fd-48ab-8db6-fee1c05b0269 0555-9047 HUMAN PRESCRIPTION DRUG Enpresse Levonorgestrel and Ethinyl Estradiol KIT 20020627 ANDA ANDA075809 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9049_d175d354-983d-4170-80e5-7c4c31ede16d 0555-9049 HUMAN PRESCRIPTION DRUG Cryselle Norgestrel and Ethinyl Estradiol KIT 20020724 ANDA ANDA075840 Teva Pharmaceuticals USA, Inc. N 20191231 0555-9050_7a391c35-2de9-467a-a835-de4bf3342feb 0555-9050 HUMAN PRESCRIPTION DRUG Kariva Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20020408 ANDA ANDA075863 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9051_79855437-35e7-459e-8f48-ce03f60102ae 0555-9051 HUMAN PRESCRIPTION DRUG Velivet Triphasic Regimen Desogestrel and Ethinyl Estradiol KIT 20040301 ANDA ANDA076455 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9064_c62a7bc3-928a-4bb3-a0ac-ebe4050e8ef6 0555-9064 HUMAN PRESCRIPTION DRUG Kelnor 1/35 Ethynodiol Diacetate and Ethinyl Estradiol KIT 20050620 ANDA ANDA076785 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9066_108b556d-6279-4127-96e8-e3e142c3530f 0555-9066 HUMAN PRESCRIPTION DRUG Aranelle norethindrone and ethinyl estradiol KIT 20041004 ANDA ANDA076783 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9123_f51e16dc-1618-45f2-964b-1e0856adc2df 0555-9123 HUMAN PRESCRIPTION DRUG Jolessa Levonorgestrel / Ethinyl Estradiol KIT 20031013 NDA AUTHORIZED GENERIC NDA021544 Teva Pharmaceuticals USA, Inc. N 20181231 0555-9131_6daee173-c467-4f50-8cdb-ffd88500e543 0555-9131 HUMAN PRESCRIPTION DRUG OCELLA drospirenone and ethinyl estradiol KIT 20010611 NDA AUTHORIZED GENERIC NDA021098 TEVA PHARMACEUTICALS USA, INC. N 20181231 0562-7805_7dbec001-faf6-4bfb-acb9-2a25b4aef01a 0562-7805 PLASMA DERIVATIVE RhoGAM Ultra-Filtered PLUS HUMAN RHO(D) IMMUNE GLOBULIN INJECTION, SOLUTION INTRAMUSCULAR 20070309 BLA BLA103777 Kedrion Melville Inc. HUMAN RHO(D) IMMUNE GLOBULIN 300 ug/1 Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 0562-7806_7dbec001-faf6-4bfb-acb9-2a25b4aef01a 0562-7806 PLASMA DERIVATIVE MICRhoGAM Ultra-Filtered PLUS HUMAN RHO(D) IMMUNE GLOBULIN INJECTION, SOLUTION INTRAMUSCULAR 20070309 BLA BLA103777 Kedrion Melville Inc. HUMAN RHO(D) IMMUNE GLOBULIN 50 ug/1 Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 0573-0133_6ecda182-4a36-469e-a47a-09f12655d5cc 0573-0133 HUMAN OTC DRUG Advil ibuprofen sodium TABLET, COATED ORAL 20130708 NDA NDA201803 Pfizer Consumer Healthcare IBUPROFEN SODIUM 256 mg/1 N 20181231 0573-0134_6ecda182-4a36-469e-a47a-09f12655d5cc 0573-0134 HUMAN OTC DRUG Advil ibuprofen sodium TABLET, COATED ORAL 20130708 NDA NDA201803 Pfizer Consumer Healthcare IBUPROFEN SODIUM 256 mg/1 N 20181231 0573-0149_5abb3d89-eed1-49b0-b8de-97171a47e610 0573-0149 HUMAN OTC DRUG Advil ibuprofen CAPSULE, LIQUID FILLED ORAL 19950410 NDA NDA020402 Wyeth Consumer Healthcare LLC IBUPROFEN 200 mg/1 N 20181231 0573-0150_8445213a-10c9-4124-b01e-0ebd6858aa57 0573-0150 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Wyeth Consumer Healthcare LLC IBUPROFEN 200 mg/1 N 20181231 0573-0151_8445213a-10c9-4124-b01e-0ebd6858aa57 0573-0151 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Wyeth Consumer Healthcare LLC IBUPROFEN 200 mg/1 N 20181231 0573-0154_8445213a-10c9-4124-b01e-0ebd6858aa57 0573-0154 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Wyeth Consumer Healthcare LLC IBUPROFEN 200 mg/1 N 20181231 0573-0160_8445213a-10c9-4124-b01e-0ebd6858aa57 0573-0160 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Wyeth Consumer Healthcare LLC IBUPROFEN 200 mg/1 N 20181231 0573-0161_8445213a-10c9-4124-b01e-0ebd6858aa57 0573-0161 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Wyeth Consumer Healthcare LLC IBUPROFEN 200 mg/1 N 20181231 0573-0164_2d70aefd-1387-40ff-bfc5-5aae97c9ff3d 0573-0164 HUMAN OTC DRUG ADVIL PM diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20051221 NDA NDA021394 Wyeth Consumer Healthcare LLC DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 0573-0165_8445213a-10c9-4124-b01e-0ebd6858aa57 0573-0165 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Wyeth Consumer Healthcare LLC IBUPROFEN 200 mg/1 N 20181231 0573-0166_8445213a-10c9-4124-b01e-0ebd6858aa57 0573-0166 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Wyeth Consumer Healthcare LLC IBUPROFEN 200 mg/1 N 20181231 0573-0167_61822ea5-d629-442f-bedb-b77115a427d4 0573-0167 HUMAN OTC DRUG ADVIL PM diphenhydramine HCl, ibuprofen CAPSULE, LIQUID FILLED ORAL 20051220 NDA NDA021393 Pfizer Consumer Healthcare DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 N 20181231 0573-0168_7eeeb4c5-d43e-4641-97df-f5ab624ef4fd 0573-0168 HUMAN OTC DRUG ADVIL MIGRAINE ibuprofen CAPSULE, LIQUID FILLED ORAL 20000316 NDA NDA020402 Pfizer Consumer Healthcare IBUPROFEN 200 mg/1 N 20181231 0573-0169_5abb3d89-eed1-49b0-b8de-97171a47e610 0573-0169 HUMAN OTC DRUG Advil ibuprofen CAPSULE, LIQUID FILLED ORAL 19950410 NDA NDA020402 Wyeth Consumer Healthcare LLC IBUPROFEN 200 mg/1 N 20181231 0573-0170_f3e560cd-36bc-4762-8e45-5112053dcdb9 0573-0170 HUMAN OTC DRUG CHILDRENS ADVIL ibuprofen SUSPENSION ORAL 19960627 NDA NDA020589 Pfizer Consumer Healthcare IBUPROFEN 100 mg/5mL N 20181231 0573-0171_f3e560cd-36bc-4762-8e45-5112053dcdb9 0573-0171 HUMAN OTC DRUG CHILDRENS ADVIL ibuprofen SUSPENSION ORAL 19960627 NDA NDA020589 Pfizer Consumer Healthcare IBUPROFEN 100 mg/5mL N 20181231 0573-0174_f3e560cd-36bc-4762-8e45-5112053dcdb9 0573-0174 HUMAN OTC DRUG CHILDRENS ADVIL ibuprofen SUSPENSION ORAL 19960627 NDA NDA020589 Pfizer Consumer Healthcare IBUPROFEN 100 mg/5mL N 20181231 0573-0175_aa90a891-147e-4e7b-a9f0-cf94f226f948 0573-0175 HUMAN OTC DRUG JUNIOR STRENGTH ADVIL ibuprofen TABLET, COATED ORAL 20110621 NDA NDA020267 Wyeth Consumer Healthcare LLC IBUPROFEN 100 mg/1 N 20181231 0573-0179_886c4258-15d2-4591-a70d-2fd46c6e09f5 0573-0179 HUMAN OTC DRUG JUNIOR STRENGTH ADVIL ibuprofen TABLET, CHEWABLE ORAL 20110601 NDA NDA020944 Pfizer Consumer Healthcare IBUPROFEN 100 mg/1 N 20181231 0573-0180_cd38175a-0c56-41b1-9a1f-7b4453ed4a13 0573-0180 HUMAN OTC DRUG ADVIL COLD AND SINUS IBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED ORAL 19890919 NDA NDA019771 Pfizer Consumer Healthcare IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 0573-0184_c6344230-a3ce-479b-bf12-7208c77a99e8 0573-0184 HUMAN OTC DRUG ADVIL COLD AND SINUS ibuprofen, pseudoephedrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20020530 NDA NDA021374 Wyeth Consumer Healthcare LLC IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 0573-0188_98903037-c65a-4428-af29-adb5fca52b56 0573-0188 HUMAN OTC DRUG ADVIL ALLERGY SINUS chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl TABLET, COATED ORAL 20021220 NDA NDA021441 Pfizer Consumer Healthcare CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 200; 30 mg/1; mg/1; mg/1 N 20181231 0573-0191_a0a0452a-6744-4e1c-8b15-5482a3bfb058 0573-0191 HUMAN OTC DRUG INFANTS ADVIL ibuprofen SUSPENSION/ DROPS ORAL 19980130 NDA NDA020812 Pfizer Consumer Healthcare IBUPROFEN 50 mg/1.25mL N 20181231 0573-0195_914f2d32-16a8-467c-bf3a-3977625486b8 0573-0195 HUMAN OTC DRUG ADVIL CONGESTION RELIEF ibuprofen and phenylephrine hydrochloride TABLET, FILM COATED ORAL 20101004 20180331 NDA NDA022565 Wyeth Consumer Healthcare LLC IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20181231 0573-0196_e43ec3c7-bb5b-4a51-9595-97d99713bda7 0573-0196 HUMAN OTC DRUG Advil Allergy and Congestion Relief chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride TABLET, COATED ORAL 20120723 NDA NDA022113 Pfizer Consumer Healthcare CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 4; 200; 10 mg/1; mg/1; mg/1 N 20181231 0573-0199_748195af-921e-4c45-8926-2b5dbfe59990 0573-0199 HUMAN OTC DRUG ADVIL SINUS CONGESTION AND PAIN ibuprofen, phenylephrine hydrochloride TABLET, COATED ORAL 20150701 NDA NDA022565 Pfizer Consumer Healthcare IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20181231 0573-0207_f3e560cd-36bc-4762-8e45-5112053dcdb9 0573-0207 HUMAN OTC DRUG CHILDRENS ADVIL ibuprofen SUSPENSION ORAL 20120904 NDA NDA020589 Pfizer Consumer Healthcare IBUPROFEN 100 mg/5mL N 20181231 0573-0213_d6cc3971-cf43-499f-a05a-fb301f4612a2 0573-0213 HUMAN OTC DRUG ANBESOL REGULAR STRENGTH benzocaine SOLUTION TOPICAL 20050511 OTC MONOGRAPH NOT FINAL part356 Wyeth Consumer Healthcare LLC BENZOCAINE 100 mg/mL N 20181231 0573-0215_d6cc3971-cf43-499f-a05a-fb301f4612a2 0573-0215 HUMAN OTC DRUG ANBESOL MAXIMUM STRENGTH benzocaine SOLUTION TOPICAL 20050511 OTC MONOGRAPH NOT FINAL part356 Wyeth Consumer Healthcare LLC BENZOCAINE 200 mg/mL N 20181231 0573-0218_d6cc3971-cf43-499f-a05a-fb301f4612a2 0573-0218 HUMAN OTC DRUG ANBESOL REGULAR STRENGTH benzocaine GEL TOPICAL 20050511 OTC MONOGRAPH NOT FINAL part356 Wyeth Consumer Healthcare LLC BENZOCAINE 100 mg/g N 20181231 0573-0225_d6cc3971-cf43-499f-a05a-fb301f4612a2 0573-0225 HUMAN OTC DRUG ANBESOL MAXIMUM STRENGTH benzocaine GEL TOPICAL 20050511 OTC MONOGRAPH NOT FINAL part356 Wyeth Consumer Healthcare LLC BENZOCAINE 200 mg/g N 20181231 0573-0230_ab38e773-2e41-42fc-8253-4acd2785b19c 0573-0230 HUMAN OTC DRUG Advil Menstrual Pain ibuprofen sodium TABLET, COATED ORAL 20160630 NDA NDA201803 Pfizer Consumer Healthcare IBUPROFEN SODIUM 256 mg/1 N 20181231 0573-0232_f3e560cd-36bc-4762-8e45-5112053dcdb9 0573-0232 HUMAN OTC DRUG CHILDRENS ADVIL ibuprofen SUSPENSION ORAL 20131220 NDA NDA020589 Pfizer Consumer Healthcare IBUPROFEN 100 mg/5mL N 20181231 0573-0246_b6232e81-a230-4969-9025-7aace921aca5 0573-0246 HUMAN OTC DRUG ANBESOL COLD SORE THERAPY allantion, benzocaine, camphor, petrolatum OINTMENT TOPICAL 20060509 OTC MONOGRAPH NOT FINAL part348 Wyeth Consumer Healthcare LLC ALLANTOIN; BENZOCAINE; CAMPHOR (SYNTHETIC); PETROLATUM 10; 200; 30; 649 mg/g; mg/g; mg/g; mg/g N 20181231 0573-0290_f3e560cd-36bc-4762-8e45-5112053dcdb9 0573-0290 HUMAN OTC DRUG CHILDRENS ADVIL ibuprofen SUSPENSION ORAL 20101201 NDA NDA020589 Pfizer Consumer Healthcare IBUPROFEN 100 mg/5mL N 20181231 0573-0556_7113425f-f3a7-081c-378a-d45a89b78ee8 0573-0556 HUMAN OTC DRUG PREPARATION H MEDICATED WIPES witch hazel CLOTH TOPICAL 20040202 OTC MONOGRAPH FINAL part346 Wyeth Consumer Healthcare WITCH HAZEL 5 g/1 N 20181231 0573-0558_a65d471b-ba8d-4fa9-8cf8-08c1066ded58 0573-0558 HUMAN OTC DRUG PREPARATION H TOTABLES IRRITATION RELIEF WIPES witch hazel CLOTH TOPICAL 20101121 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare WITCH HAZEL 5 g/1 N 20181231 0573-0559_58491366-3283-4207-961c-1867e13bc866 0573-0559 HUMAN OTC DRUG PREPARATION H FOR WOMEN witch hazel CLOTH TOPICAL 20140401 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare WITCH HAZEL 2 g/1 N 20181231 0573-1191_a610b9a8-110e-46aa-b8ed-58d7bb16db7f 0573-1191 HUMAN OTC DRUG DRISTAN 12 HR OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20040101 OTC MONOGRAPH FINAL part341 Pfizer Consumer Healthcare OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 0573-1238_05c0b326-1265-4e96-8408-3e03fa999b62 0573-1238 HUMAN OTC DRUG DRISTAN COLD MULTISYMPTOM acetaminophen, chlorpheniramine maleate, phenylephrine HCl TABLET ORAL 20050505 OTC MONOGRAPH FINAL part341 Pfizer Consumer Healthcare ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 0573-1711_8445213a-10c9-4124-b01e-0ebd6858aa57 0573-1711 HUMAN OTC DRUG ADVIL ibuprofen TABLET, COATED ORAL 19840518 NDA NDA018989 Wyeth Consumer Healthcare LLC IBUPROFEN 200 mg/1 N 20181231 0573-1769_5abb3d89-eed1-49b0-b8de-97171a47e610 0573-1769 HUMAN OTC DRUG Advil ibuprofen CAPSULE, LIQUID FILLED ORAL 20170308 NDA NDA020402 Wyeth Consumer Healthcare LLC IBUPROFEN 200 mg/1 N 20181231 0573-1900_e105cd3c-5b48-6959-16be-4e2c44008c68 0573-1900 HUMAN OTC DRUG CHAPSTICK CLASSICS ORIGINAL padimate O, petrolatum STICK TOPICAL 20040101 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PADIMATE O; PETROLATUM 15; 440 mg/g; mg/g N 20181231 0573-1901_4cf3a99e-92cc-444c-91f2-08d3cb2d8e3e 0573-1901 HUMAN OTC DRUG ChapStick Classic Original PETROLATUM STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PETROLATUM 450 mg/g N 20181231 0573-1905_e105cd3c-5b48-6959-16be-4e2c44008c68 0573-1905 HUMAN OTC DRUG CHAPSTICK CLASSICS CHERRY padimate O, petrolatum STICK TOPICAL 20040128 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PADIMATE O; PETROLATUM 15; 440 mg/g; mg/g N 20181231 0573-1906_cf44f7c7-4cfa-4c63-9140-0bc8c890cc4d 0573-1906 HUMAN OTC DRUG ChapStick Classic Cherry PETROLATUM STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PETROLATUM 450 mg/g N 20181231 0573-1911_e105cd3c-5b48-6959-16be-4e2c44008c68 0573-1911 HUMAN OTC DRUG CHAPSTICK CLASSICS SPEARMINT padimate O, petrolatum STICK TOPICAL 20040101 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PADIMATE O; PETROLATUM 15; 440 mg/g; mg/g N 20181231 0573-1912_82ea8570-03fb-4418-bcba-aeeab3c47ec9 0573-1912 HUMAN OTC DRUG ChapStick Classic Spearmint PETROLATUM STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PETROLATUM 450 mg/g N 20181231 0573-1915_e105cd3c-5b48-6959-16be-4e2c44008c68 0573-1915 HUMAN OTC DRUG CHAPSTICK CLASSICS STRAWBERRY padimate O, petrolatum STICK TOPICAL 20040101 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PADIMATE O; PETROLATUM 15; 440 mg/g; mg/g N 20181231 0573-1916_854fbc99-caed-4f95-b0ff-643a21a2249c 0573-1916 HUMAN OTC DRUG ChapStick Classic Strawberry PETROLATUM STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare PETROLATUM 450 mg/g N 20181231 0573-1920_d8f09f7f-08a6-4989-8c44-18f3ef89917a 0573-1920 HUMAN OTC DRUG CHAPSTICK MEDICATED camphor, menthol, petrolatum, phenol STICK TOPICAL 20040501 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare CAMPHOR (SYNTHETIC); MENTHOL; PETROLATUM; PHENOL 10; 6; 410; 5 mg/g; mg/g; mg/g; mg/g N 20181231 0573-1925_ad5635f7-d78e-4b04-8b77-080f042c2346 0573-1925 HUMAN OTC DRUG CHAPSTICK MOISTURIZER octinoxate, oxybenzone, petrolatum STICK TOPICAL 20041101 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 407 mg/g; mg/g; mg/g N 20181231 0573-1926_109022e9-7bd1-e5c2-1fc7-d9c978a6c603 0573-1926 HUMAN OTC DRUG CHAPSTICK MOISTURIZER octinoxate, oxybenzone, petrolatum GEL TOPICAL 20040101 OTC MONOGRAPH FINAL part347 Wyeth Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 330 mg/g; mg/g; mg/g N 20181231 0573-1927_51c60a46-fcde-4b17-97da-804b05cc994a 0573-1927 HUMAN OTC DRUG Chapstick Moisturizer OCTINOXATE, OXYBENZONE, and PETROLATUM STICK ORAL 20120803 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 387 mg/g; mg/g; mg/g N 20181231 0573-1928_ad5635f7-d78e-4b04-8b77-080f042c2346 0573-1928 HUMAN OTC DRUG CHAPSTICK MOISTURIZER GREEN APPLE octinoxate, oxybenzone, petrolatum STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 334 mg/g; mg/g; mg/g N 20181231 0573-1929_d7c411cd-a901-027f-124b-87c44860e9cc 0573-1929 HUMAN OTC DRUG CHAPSTICK LIPSHIELD 365 avobenzone, dimethicone, homosalate, octinoxate, octisalate, oxybenzone STICK TOPICAL 20110701 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare AVOBENZONE; DIMETHICONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 15; 60; 65; 45; 50 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 0573-1930_ad5635f7-d78e-4b04-8b77-080f042c2346 0573-1930 HUMAN OTC DRUG CHAPSTICK MOISTURIZER VANILLA MINT octinoxate, oxybenzone, petrolatum STICK TOPICAL 20040723 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 387 mg/g; mg/g; mg/g N 20181231 0573-1934_ab6d1370-c05d-4f6c-91af-8a525b8a6bd3 0573-1934 HUMAN OTC DRUG Chapstick Moisturizer Raspberry Creme octinoxate, oxybenzone and petrolatum STICK TOPICAL 20120803 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 387 mg/4g; mg/4g; mg/4g N 20181231 0573-1935_bb9f917d-0fb9-755b-4a99-e4892dbfc2f3 0573-1935 HUMAN OTC DRUG CHAPSTICK OVERNIGHT dimethicone GEL TOPICAL 20040101 OTC MONOGRAPH FINAL part347 Pfizer Consumer Healthcare DIMETHICONE 20 mg/g N 20181231 0573-1940_507b4f1b-dac0-4949-bb29-6e49438a2b83 0573-1940 HUMAN OTC DRUG CHAPSTICK ULTRA SPF 30 OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, PETROLATUM STICK TOPICAL 20040130 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; PETROLATUM 75; 50; 70; 50; 300 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 0573-1945_5780e0a2-e9af-4f9b-af6c-dea115bdb5a8 0573-1945 HUMAN OTC DRUG CHAPSTICK FLAVA CRAZE petrolatum KIT 20060714 OTC MONOGRAPH FINAL part347 Pfizer Consumer HealthCare N 20181231 0573-1961_af68c94c-e624-4cf4-8f37-f03159116519 0573-1961 HUMAN OTC DRUG ChapStick Hydration Lock Day and Night white petrolatum, octinoxate, oxybenzone KIT 20140801 OTC MONOGRAPH FINAL part352 Wyeth Consumer Healthcare LLC N 20181231 0573-1993_99c72544-0aa3-179b-4b74-3d74b7ed539d 0573-1993 HUMAN OTC DRUG CHAPSTICK ULTRA MOISTURE octinoxate, oxybenzone, petrolatum GEL TOPICAL 20101209 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 330 mg/g; mg/g; mg/g N 20181231 0573-1999_ff6541c7-e508-4672-8d11-11aa0594e285 0573-1999 HUMAN OTC DRUG ChapStick Active Sport Ready AVOBENZONE, DIMETHICONE 100, HOMOSALATE, OCTINOXATE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20120730 OTC MONOGRAPH FINAL part352 Pfizer Consumer Healthcare AVOBENZONE; DIMETHICONE 100; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 15; 60; 65; 45; 50 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 0573-2450_cb5e72e3-fe55-4ebf-8ca7-812e51084ef4 0573-2450 HUMAN OTC DRUG Nexium 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20140527 NDA NDA204655 Wyeth Consumer Healthcare LLC ESOMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 0573-2451_14360867-4c81-4e33-b2ba-8c9b481fc6ab 0573-2451 HUMAN OTC DRUG Nexium 24HR esomeprazole magnesium TABLET ORAL 20160206 NDA NDA207920 Wyeth Consumer Healthcare LLC ESOMEPRAZOLE MAGNESIUM 20 mg/1 N 20191231 0573-2452_cb5e72e3-fe55-4ebf-8ca7-812e51084ef4 0573-2452 HUMAN OTC DRUG Nexium 24HR ClearMinis esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20170301 NDA NDA204655 Wyeth Consumer Healthcare LLC ESOMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 0573-2620_1b2a55bb-e219-4eff-a425-e7bddd079b04 0573-2620 HUMAN OTC DRUG ALAVERT ALLERGY loratadine TABLET, ORALLY DISINTEGRATING ORAL 20021219 NDA NDA021375 Wyeth Consumer Healthcare LLC LORATADINE 10 mg/1 N 20181231 0573-2621_1b2a55bb-e219-4eff-a425-e7bddd079b04 0573-2621 HUMAN OTC DRUG ALAVERT ALLERGY loratadine TABLET, ORALLY DISINTEGRATING ORAL 20021219 NDA NDA021375 Wyeth Consumer Healthcare LLC LORATADINE 10 mg/1 N 20181231 0573-2660_91ed3e9a-e637-bfd9-e403-eef89c2c6816 0573-2660 HUMAN OTC DRUG ALAVERT ALLERGY SINUS D-12 loratadine, pseudoephedrine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040130 ANDA ANDA076050 Wyeth Consumer Healthcare LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 0573-2830_b1db6c15-2f10-abed-12ef-0f0318ea8047 0573-2830 HUMAN OTC DRUG PREPARATION H HYDROCORTISONE hydrocortisone CREAM TOPICAL 20040101 OTC MONOGRAPH FINAL part348 Pfizer Consumer Healthcare HYDROCORTISONE 10 mg/g N 20181231 0573-2840_e14f1f6b-339f-6928-f126-f4bc95000499 0573-2840 HUMAN OTC DRUG PREPARATION H COOLING GEL phenylephrine HCl, witch hazel GEL TOPICAL 20040101 OTC MONOGRAPH FINAL part346 Wyeth Consumer Healthcare PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 2.5; 500 mg/g; mg/g N 20181231 0573-2841_a887d291-38d1-4115-8e20-1b51aa97af9c 0573-2841 HUMAN OTC DRUG Preparation H Totables Burning Relief phenylephrine hydrochloride and witch hazel GEL TOPICAL 20101010 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 2.5; 500 mg/g; mg/g N 20181231 0573-2842_9e9c1f88-fece-4605-96f8-2c87d51bafea 0573-2842 HUMAN OTC DRUG Preparation H Rapid Relief Glycerin, Lidocaine CREAM TOPICAL 20170118 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare GLYCERIN; LIDOCAINE 144; 50 mg/g; mg/g N 20181231 0573-2868_eded91a5-e3e3-4513-8754-2f2dfb8e168a 0573-2868 HUMAN OTC DRUG PREPARATION H MAXIMUM STRENGTH glycerin, petrolatum, phenylephrine HCl, pramoxine HCl CREAM TOPICAL 20040701 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 144; 2.5; 10; 150 mg/g; mg/g; mg/g; mg/g N 20181231 0573-2869_201803ec-aa3d-4627-914c-44a8f2463c88 0573-2869 HUMAN OTC DRUG Preparation H Totables Pain Relief GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, and PETROLATUM CREAM TOPICAL 20101010 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 144; 2.5; 10; 150 mg/g; mg/g; mg/g; mg/g N 20181231 0573-2871_2c7d0a4e-d12e-4e98-9ec3-57164beabc8b 0573-2871 HUMAN OTC DRUG PREPARATION H mineral oil, petrolatum, phenylephrine HCl OINTMENT TOPICAL 20040301 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL; PETROLATUM 2.5; 140; 749 mg/g; mg/g; mg/g N 20181231 0573-2880_65655b15-a3aa-4e0f-910f-641b9813086d 0573-2880 HUMAN OTC DRUG PREPARATION H cocoa butter, phenylephrine hydrochloride SUPPOSITORY RECTAL 20040105 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.25 mg/1; mg/1 N 20181231 0573-2883_65655b15-a3aa-4e0f-910f-641b9813086d 0573-2883 HUMAN OTC DRUG PREPARATION H cocoa butter, phenylephrine hydrochloride SUPPOSITORY RECTAL 20040105 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.25 mg/1; mg/1 N 20181231 0573-2884_052f579c-8739-4cac-972d-89d2758579d7 0573-2884 HUMAN OTC DRUG Preparation H cocoa butter, phenylephrine hydrochloride, and witch hazel KIT 20150701 OTC MONOGRAPH FINAL part346 Pfizer Consumer Healthcare N 20181231 0573-2952_983b7623-b288-48db-961c-64dcc6a758c1 0573-2952 HUMAN OTC DRUG PRIMATENE ephedrine hcl, guaifenesin TABLET ORAL 20040106 OTC MONOGRAPH FINAL part341 Pfizer Consumer Healthcare EPHEDRINE HYDROCHLORIDE; GUAIFENESIN 12.5; 200 mg/1; mg/1 N 20181231 0574-0067_cba29e3c-d446-4a70-928a-c98ed8eedcc6 0574-0067 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part333A Paddock Laboratories, LLC ISOPROPYL ALCOHOL 500 mg/mL N 20181231 0574-0106_3aee936d-1278-49f1-b09a-083245f07530 0574-0106 HUMAN PRESCRIPTION DRUG Bromocriptine mesylate Bromocriptine mesylate TABLET ORAL 20140401 ANDA ANDA077646 Paddock Laboratories, LLC BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 0574-0107_75b943d4-1bd4-49f5-bc42-f435d6d02a38 0574-0107 HUMAN PRESCRIPTION DRUG Clotrimazole clotrimazole LOZENGE ORAL 20051201 ANDA ANDA076763 Paddock Laboratories, LLC CLOTRIMAZOLE 10 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0574-0113_17f89d5a-4a9f-4f36-b8c6-b89f3d084df8 0574-0113 HUMAN PRESCRIPTION DRUG Calcium Acetate CALCIUM ACETATE TABLET ORAL 20110913 ANDA ANDA091561 Paddock Laboratories, LLC CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0574-0115_f0cab6ed-5ce0-4216-8877-3b1fe082254e 0574-0115 HUMAN PRESCRIPTION DRUG FLAVOXATE HYDROCHLORIDE FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED ORAL 20041222 ANDA ANDA076831 Paddock Laboratories, LLC FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0574-0118_1655a4b9-45e5-4771-9e21-02042be7ada5 0574-0118 HUMAN PRESCRIPTION DRUG Trospium Chloride ER Trospium Chloride CAPSULE, EXTENDED RELEASE ORAL 20130607 ANDA ANDA201291 Paddock Laboratories, LLC TROSPIUM CHLORIDE 60 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0574-0120_a003785a-602c-4ac1-aa71-fa56b4329a6c 0574-0120 HUMAN PRESCRIPTION DRUG Actidose Activated Charcoal SUSPENSION ORAL 19831001 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC ACTIVATED CHARCOAL 208 mg/mL N 20181231 0574-0121_a003785a-602c-4ac1-aa71-fa56b4329a6c 0574-0121 HUMAN PRESCRIPTION DRUG Actidose Aqua activated charcoal SUSPENSION ORAL 19840101 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC ACTIVATED CHARCOAL 208 mg/mL N 20181231 0574-0122_ff6811b0-d845-4d77-8edd-aaaa3d62ce99 0574-0122 HUMAN OTC DRUG EZ Char Activated charcoal PELLET ORAL 20020114 OTC MONOGRAPH NOT FINAL part357A Paddock Laboratories, LLC ACTIVATED CHARCOAL 25 g/25g N 20181231 0574-0129_69595a2e-bbc0-4c4b-8481-a1eb0872b9a5 0574-0129 HUMAN PRESCRIPTION DRUG Clindamycin Palmitate Hydrochloride Clindamycin Palmitate Hydrochloride GRANULE, FOR SOLUTION ORAL 20100121 ANDA ANDA090902 Paddock Laboratories, LLC CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0574-0145_e2b59be1-78b2-4d8d-88c9-7edfbcb3ce1f 0574-0145 HUMAN PRESCRIPTION DRUG TROSPIUM CHLORIDE TROSPIUM CHLORIDE TABLET, FILM COATED ORAL 20101117 ANDA ANDA091573 Paddock Laboratories, LLC TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0574-0150_e6db6b77-7aae-4d5c-8c3f-0ccc13a63b37 0574-0150 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL 20050502 ANDA ANDA076379 Paddock Laboratories, LLC MIDAZOLAM HYDROCHLORIDE 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0574-0153_62240c03-35ba-44df-99e7-2db8acbc20f1 0574-0153 HUMAN PRESCRIPTION DRUG morphine sulfate Morphine Sulfate SOLUTION ORAL 20120817 ANDA ANDA201574 Paddock Laboratories, LLC MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 0574-0180_2c824a0e-afca-4959-b09b-279f518864ca 0574-0180 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200185 Paddock Laboratories, LLC POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0574-0181_2c824a0e-afca-4959-b09b-279f518864ca 0574-0181 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200185 Paddock Laboratories, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0574-0214_ff4c0d67-2618-4bd5-a8e2-9c2dbab0a710 0574-0214 HUMAN PRESCRIPTION DRUG Naratriptan Hydrochloride Naratriptan Hydrochloride TABLET, FILM COATED ORAL 20100708 ANDA ANDA091326 Paddock Laboratories, LLC NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0574-0215_ff4c0d67-2618-4bd5-a8e2-9c2dbab0a710 0574-0215 HUMAN PRESCRIPTION DRUG Naratriptan Hydrochloride Naratriptan Hydrochloride TABLET, FILM COATED ORAL 20100708 20180331 ANDA ANDA091326 Paddock Laboratories, LLC NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0574-0220_8b472802-4d0a-478b-96d1-1d03ac7d9b2a 0574-0220 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Paddock Laboratories, LLC LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 0574-0222_8b472802-4d0a-478b-96d1-1d03ac7d9b2a 0574-0222 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Paddock Laboratories, LLC LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 0574-0223_8b472802-4d0a-478b-96d1-1d03ac7d9b2a 0574-0223 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Paddock Laboratories, LLC LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 0574-0240_e5bfb401-a51b-4a08-9a43-a9b640250323 0574-0240 HUMAN PRESCRIPTION DRUG Repaglinide REPAGLINIDE TABLET ORAL 20130809 ANDA ANDA201189 Paddock Laboratories, LLC REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0574-0241_e5bfb401-a51b-4a08-9a43-a9b640250323 0574-0241 HUMAN PRESCRIPTION DRUG Repaglinide REPAGLINIDE TABLET ORAL 20140122 ANDA ANDA201189 Paddock Laboratories, LLC REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0574-0242_e5bfb401-a51b-4a08-9a43-a9b640250323 0574-0242 HUMAN PRESCRIPTION DRUG Repaglinide REPAGLINIDE TABLET ORAL 20140122 ANDA ANDA201189 Paddock Laboratories, LLC REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0574-0274_1d6de7b6-5dc1-4077-9a4b-95e11e346cf4 0574-0274 HUMAN PRESCRIPTION DRUG Potassium chloride extended release Potassium chloride TABLET, EXTENDED RELEASE ORAL 20151211 ANDA ANDA205993 Paddock Laboratories, LLC POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0574-0275_1d6de7b6-5dc1-4077-9a4b-95e11e346cf4 0574-0275 HUMAN PRESCRIPTION DRUG Potassium chloride extended release Potassium chloride TABLET, EXTENDED RELEASE ORAL 20151211 ANDA ANDA205993 Paddock Laboratories, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0574-0279_1383d713-79b9-45bd-bd06-65707f28bc99 0574-0279 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine CAPSULE ORAL 20171003 NDA NDA204516 Paddock Laboratories, LLC PAROXETINE MESYLATE 7.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0574-0292_8f143a75-f765-4eb8-9bc5-e93fb0d0d647 0574-0292 HUMAN PRESCRIPTION DRUG amiloride hydrocloride amiloride hydrocloride TABLET ORAL 20090406 NDA NDA018200 Paddock Laboratories, LLC AMILORIDE HYDROCHLORIDE 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 0574-0293_1b421681-6a29-4b72-9e35-186556e11636 0574-0293 HUMAN PRESCRIPTION DRUG hydromorphone hydrochloride hydromorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20150522 ANDA ANDA204278 Paddock Laboratories, LLC HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0574-0294_1b421681-6a29-4b72-9e35-186556e11636 0574-0294 HUMAN PRESCRIPTION DRUG hydromorphone hydrochloride hydromorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20150522 ANDA ANDA204278 Paddock Laboratories, LLC HYDROMORPHONE HYDROCHLORIDE 12 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0574-0295_1b421681-6a29-4b72-9e35-186556e11636 0574-0295 HUMAN PRESCRIPTION DRUG hydromorphone hydrochloride hydromorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20150522 ANDA ANDA204278 Paddock Laboratories, LLC HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0574-0297_1b421681-6a29-4b72-9e35-186556e11636 0574-0297 HUMAN PRESCRIPTION DRUG hydromorphone hydrochloride hydromorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20170929 ANDA ANDA204278 Paddock Laboratories, LLC HYDROMORPHONE HYDROCHLORIDE 32 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0574-0412_9bdadbdd-e5d9-4783-976f-9ca5161408ab 0574-0412 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20060524 ANDA ANDA077893 Paddock Laboratories, LLC POLYETHYLENE GLYCOL 3350 17 g/17g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 0574-0601_de96dc6e-e6d1-4383-9ce1-4d06bac08e00 0574-0601 HUMAN PRESCRIPTION DRUG Podocon 25 Podophyllum resin TINCTURE TOPICAL 19900901 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC PODOPHYLLUM RESIN 1 mg/4mL N 20181231 0574-0611_0374a375-639c-439d-914c-538b1e790c07 0574-0611 HUMAN PRESCRIPTION DRUG PODOFILOX PODOFILOX SOLUTION TOPICAL 20020129 ANDA ANDA075600 Paddock Laboratories, LLC PODOFILOX 5 mg/mL Decreased Mitosis [PE] N 20181231 0574-0786_7731560b-dbe7-4912-814e-ef60629e5f07 0574-0786 HUMAN PRESCRIPTION DRUG Neptazane methazolamide TABLET ORAL 20150112 ANDA ANDA040062 Paddock Laboratories, LLC METHAZOLAMIDE 25 mg/1 N 20181231 0574-0787_7731560b-dbe7-4912-814e-ef60629e5f07 0574-0787 HUMAN PRESCRIPTION DRUG Neptazane methazolamide TABLET ORAL 20150112 ANDA ANDA040062 Paddock Laboratories, LLC METHAZOLAMIDE 50 mg/1 N 20181231 0574-0790_a08256f9-af80-445e-9b01-23f99222324e 0574-0790 HUMAN PRESCRIPTION DRUG methazolamide methazolamide TABLET ORAL 20140930 ANDA ANDA040062 Paddock Laboratories, LLC METHAZOLAMIDE 25 mg/1 N 20181231 0574-0791_a08256f9-af80-445e-9b01-23f99222324e 0574-0791 HUMAN PRESCRIPTION DRUG methazolamide methazolamide TABLET ORAL 20140930 ANDA ANDA040062 Paddock Laboratories, LLC METHAZOLAMIDE 50 mg/1 N 20181231 0574-0805_fb11459b-cf70-4627-baa7-681358a5815f 0574-0805 HUMAN PRESCRIPTION DRUG acetylcysteine Acetylcysteine INJECTION INTRAVENOUS 20121220 NDA NDA021539 Paddock Laboratories, LLC ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 0574-0815_c6b870bb-ec25-4aad-9d93-a73fff0d11ea 0574-0815 HUMAN PRESCRIPTION DRUG Acetylcysteine acetylcysteine INJECTION INTRAVENOUS 20131015 NDA NDA021539 Paddock Laboratories, LLC ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 0574-0820_4110fcac-23c5-4295-9dd5-29b2b6c90b9a 0574-0820 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20071221 ANDA ANDA040530 Paddock Laboratories, LLC TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0574-0850_50d789bd-18ce-420d-8410-960394341433 0574-0850 HUMAN PRESCRIPTION DRUG Dihydroergotamine Mesylate Dihydroergotamine Mesylate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20030429 ANDA ANDA040475 Paddock Laboratories, LLC DIHYDROERGOTAMINE MESYLATE 1 mg/mL Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient] N 20181231 0574-0858_c89342c3-133c-4860-ac05-46c96d765a41 0574-0858 HUMAN PRESCRIPTION DRUG Colistimethate COLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140415 20180630 ANDA ANDA065177 Paddock Laboratories, LLC COLISTIMETHATE SODIUM 150 mg/2mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 0574-0866_ec477b0e-d071-41b9-8bbf-215b89fa8f8e 0574-0866 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine INJECTION, SOLUTION INTRAVENOUS 20031007 ANDA ANDA065151 Perrigo Company CYCLOSPORINE 50 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0574-0870_6dc38a6a-64c2-4af0-8a3f-dcf00bb3afb7 0574-0870 HUMAN PRESCRIPTION DRUG ESTRADIOL VALERATE ESTRADIOL VALERATE INJECTION, SOLUTION INTRAMUSCULAR 20100331 ANDA ANDA090920 Perrigo Company ESTRADIOL VALERATE 20 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0574-0872_6dc38a6a-64c2-4af0-8a3f-dcf00bb3afb7 0574-0872 HUMAN PRESCRIPTION DRUG ESTRADIOL VALERATE ESTRADIOL VALERATE INJECTION, SOLUTION INTRAMUSCULAR 20100331 ANDA ANDA090920 Perrigo Company ESTRADIOL VALERATE 40 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0574-1103_5f5fd864-8453-4ada-88a8-c4843edd1178 0574-1103 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride SOLUTION ORAL 20140826 ANDA ANDA204627 Paddock Laboratories, LLC HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 4; 60 mg/5mL; mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CII N 20181231 0574-1104_f09aa877-65ee-46b2-aadc-efeca0be3712 0574-1104 HUMAN PRESCRIPTION DRUG Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide SYRUP ORAL 20150206 ANDA ANDA205292 Paddock Laboratories, LLC BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 2; 30; 10 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] N 20181231 0574-1105_4c732e54-76ba-4b28-bbde-a45a02c760c6 0574-1105 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone bitartrate, homatropine methylbromide SOLUTION ORAL 20170616 ANDA ANDA205731 Paddock Laboratories, LLC HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0574-2002_19bd0782-e6da-4894-9fad-5831aed1d25f 0574-2002 HUMAN PRESCRIPTION DRUG Kionex Sodium Polystyrene Sulfonate SUSPENSION ORAL; RECTAL 20081230 ANDA ANDA040028 Paddock Laboratories, LLC SODIUM POLYSTYRENE SULFONATE 15 g/60mL N 20181231 0574-2003_aed1e5a5-104b-4074-8184-e4c680390383 0574-2003 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate SUSPENSION ORAL; RECTAL 20110921 ANDA ANDA090590 Paddock Laboratories, LLC SODIUM POLYSTYRENE SULFONATE 15 g/60mL N 20181231 0574-2004_856c5cd8-008f-43e5-aad3-42f2c260749f 0574-2004 HUMAN PRESCRIPTION DRUG Kionex SODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION ORAL; RECTAL 19980201 20180731 ANDA ANDA040029 Paddock Laboratories, LLC SODIUM POLYSTYRENE SULFONATE 4.1 meq/g N 20181231 0574-2008_233f198b-cf3d-41ed-8094-60315dc46919 0574-2008 HUMAN PRESCRIPTION DRUG Nystop Nystatin POWDER TOPICAL 19960816 ANDA ANDA064118 Paddock Laboratories, LLC NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0574-2020_5032a76b-2dae-498b-83d5-2752a6920c61 0574-2020 HUMAN PRESCRIPTION DRUG Colocort Hydrocortisone SUSPENSION RECTAL 19991231 ANDA ANDA075172 Paddock Laboratories, LLC HYDROCORTISONE 100 mg/60mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0574-2061_27e71fda-56ba-447e-9f40-ae4963d9c1c8 0574-2061 HUMAN PRESCRIPTION DRUG CICLOPIROX CICLOPIROX GEL TOPICAL 20090107 ANDA ANDA078266 Paddock Laboratories, LLC CICLOPIROX 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 0574-2063_5dba38a2-3d70-4305-bedf-1ad448ef845a 0574-2063 HUMAN PRESCRIPTION DRUG Clobetasol Propionate CLOBETASOL PROPIONATE SPRAY TOPICAL 20150102 ANDA ANDA090898 Paddock Laboratories, LLC CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0574-2067_b88bf95e-fde7-44b1-870b-fdffc4a71aba 0574-2067 HUMAN PRESCRIPTION DRUG Evamist Estradiol SPRAY TRANSDERMAL 20150411 NDA NDA022014 Paddock Laboratories, LLC ESTRADIOL 1.53 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0574-2103_6cb5d2c9-29be-4ddd-ab67-e8e8a25a0a8d 0574-2103 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate LOTION TOPICAL 20120103 NDA AUTHORIZED GENERIC NDA021535 Paddock Laboratories, LLC CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0574-2201_20eca11e-3225-430d-9f28-bc108d05e3ae 0574-2201 HUMAN PRESCRIPTION DRUG TRETINOIN tretinoin CREAM TOPICAL 20170330 ANDA ANDA075213 Paddock Laboratories, LLC TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0574-2205_20eca11e-3225-430d-9f28-bc108d05e3ae 0574-2205 HUMAN PRESCRIPTION DRUG TRETINOIN tretinoin CREAM TOPICAL 20170426 ANDA ANDA075265 Paddock Laboratories, LLC TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0574-2225_20eca11e-3225-430d-9f28-bc108d05e3ae 0574-2225 HUMAN PRESCRIPTION DRUG TRETINOIN tretinoin CREAM TOPICAL 20170615 ANDA ANDA075264 Paddock Laboratories, LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0574-2301_20eca11e-3225-430d-9f28-bc108d05e3ae 0574-2301 HUMAN PRESCRIPTION DRUG TRETINOIN tretinoin GEL TOPICAL 20170330 ANDA ANDA075589 Paddock Laboratories, LLC TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0574-2325_20eca11e-3225-430d-9f28-bc108d05e3ae 0574-2325 HUMAN PRESCRIPTION DRUG TRETINOIN tretinoin GEL TOPICAL 20170307 ANDA ANDA075529 Paddock Laboratories, LLC TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0574-4021_3abbfb58-26d1-460d-a60f-db63c0193a0d 0574-4021 HUMAN PRESCRIPTION DRUG polycin bacitracin zinc and polymyxin b sulfates OINTMENT OPHTHALMIC 20141112 ANDA ANDA065022 Paddock Laboratories, LLC BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 0574-4022_6ed2f2bd-9d2f-46af-a44c-95a02ca034de 0574-4022 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin OINTMENT OPHTHALMIC 20140310 ANDA ANDA061212 Paddock Laboratories, LLC BACITRACIN 500 [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE] N 20181231 0574-4024_87b45f99-a4d1-47e0-bbb6-50ca19c10010 0574-4024 HUMAN PRESCRIPTION DRUG erythromycin erythromycin OINTMENT OPHTHALMIC 20140508 ANDA ANDA062447 Paddock Laboratories, LLC ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0574-4025_4b8ca103-c863-492b-adc5-9691f01e795b 0574-4025 HUMAN OTC DRUG Puralube Light mineral oil, white petrolatum OINTMENT OPHTHALMIC 20140728 OTC MONOGRAPH FINAL part349 Paddock Laboratories, LLC LIGHT MINERAL OIL; PETROLATUM 150; 850 mg/g; mg/g N 20181231 0574-4144_c9996e7a-36f0-4e2e-b887-91d1d06b326e 0574-4144 HUMAN PRESCRIPTION DRUG Neo Polycin HC neomycin and polymyxin b sulfates, bacitracin zinc and hydrocortisone acetate OINTMENT OPHTHALMIC 20150107 ANDA ANDA062166 Paddock Laboratories, LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE ACETATE 3.5; 10000; 400; 10 mg/g; [USP'U]/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0574-4160_c8ae4afe-4f06-4441-9c5b-52f485f8f2f5 0574-4160 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin, Polymyxin B Sulfates, Dexamethasone OINTMENT OPHTHALMIC 20140703 ANDA ANDA062938 Paddock Laboratories, LLC DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 0574-4190_558280c6-893e-4645-9018-40c69be936d3 0574-4190 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium OINTMENT OPHTHALMIC 20140813 ANDA ANDA080029 Paddock Laboratories, LLC SULFACETAMIDE SODIUM 100 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0574-4250_cf18b051-b656-4f46-8b69-a1df6f5d8d29 0574-4250 HUMAN PRESCRIPTION DRUG Neo Polycin neomycin and polymyxin B sulfates and bacitracin zinc OINTMENT OPHTHALMIC 20150105 ANDA ANDA060764 Paddock Laboratories, LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] N 20181231 0574-7034_cce244aa-cd79-49c8-b68e-267f2bd0ef67 0574-7034 HUMAN OTC DRUG aspirin aspirin SUPPOSITORY RECTAL 19900901 OTC MONOGRAPH NOT FINAL part343 Paddock Laboratories, LLC ASPIRIN 300 mg/1 N 20181231 0574-7036_cce244aa-cd79-49c8-b68e-267f2bd0ef67 0574-7036 HUMAN OTC DRUG aspirin aspirin SUPPOSITORY RECTAL 19900901 OTC MONOGRAPH NOT FINAL part343 Paddock Laboratories, LLC ASPIRIN 600 mg/1 N 20181231 0574-7040_e1cad66c-88a7-487f-88a4-d5cab33dc3d0 0574-7040 HUMAN PRESCRIPTION DRUG Belladonna and Opium ATROPA BELLADONNA and OPIUM SUPPOSITORY RECTAL 19970422 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC ATROPA BELLADONNA; OPIUM 16.2; 60 mg/1; mg/1 CII N 20181231 0574-7045_e1cad66c-88a7-487f-88a4-d5cab33dc3d0 0574-7045 HUMAN PRESCRIPTION DRUG Belladonna and Opium ATROPA BELLADONNA and OPIUM SUPPOSITORY RECTAL 19940501 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC ATROPA BELLADONNA; OPIUM 16.2; 30 mg/1; mg/1 CII N 20181231 0574-7050_7eada0fc-5f83-43da-a56f-b0f537298208 0574-7050 HUMAN OTC DRUG Bisacodyl bisacodyl SUPPOSITORY RECTAL 19900901 OTC MONOGRAPH NOT FINAL part334 Paddock Laboratories, LLC BISACODYL 10 mg/1 N 20181231 0574-7090_7c7b684f-b42d-4f50-bb0e-dee5b13941ab 0574-7090 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 19900701 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0574-7093_c47f2d23-f2d7-43ad-899c-356d3b3dabfd 0574-7093 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20030707 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC HYDROCORTISONE ACETATE 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0574-7110_0ff975fb-7a12-4e52-a018-bffe1e32f41a 0574-7110 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE SUPPOSITORY RECTAL 19900901 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC MORPHINE SULFATE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0574-7112_0ff975fb-7a12-4e52-a018-bffe1e32f41a 0574-7112 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE SUPPOSITORY RECTAL 19900901 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0574-7114_0ff975fb-7a12-4e52-a018-bffe1e32f41a 0574-7114 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE SUPPOSITORY RECTAL 19900901 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0574-7116_0ff975fb-7a12-4e52-a018-bffe1e32f41a 0574-7116 HUMAN PRESCRIPTION DRUG Morphine Sulfate MORPHINE SULFATE SUPPOSITORY RECTAL 19900901 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0574-7224_79b1bf83-3bae-4aee-bca6-51cb698f4eb5 0574-7224 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE SUPPOSITORY RECTAL 19960131 UNAPPROVED DRUG OTHER Paddock Laboratories, LLC HYDROMORPHONE HYDROCHLORIDE 3 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0574-7226_f4970f78-235a-4e31-b31c-96e1f61a201f 0574-7226 HUMAN PRESCRIPTION DRUG Compro PROCHLORPERAZINE SUPPOSITORY RECTAL 20000901 ANDA ANDA040246 Paddock Laboratories, LLC PROCHLORPERAZINE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0574-9119_5fb3a51b-9964-d696-e053-2991aa0a1dfb 0574-9119 HUMAN OTC DRUG compound benzoin compound benzoin TINCTURE TOPICAL 20140402 20210731 OTC MONOGRAPH NOT FINAL part356 Paddock Laboratories, LLC BENZOIN RESIN 100 mg/mL N 20181231 0574-9850_a21c0cfa-827b-4abd-b873-5f3a65819357 0574-9850 HUMAN PRESCRIPTION DRUG Entocort EC Budesonide CAPSULE ORAL 20011029 NDA NDA021324 Paddock Laboratories, LLC BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0575-6200_a2410f90-c096-4421-8f1b-04c136018cea 0575-6200 HUMAN PRESCRIPTION DRUG Proglycem diazoxide SUSPENSION ORAL 19900930 NDA NDA017453 Teva Branded Pharmaceutical Products R&D, Inc. DIAZOXIDE 50 mg/mL N 20181231 0591-0149_db7709cd-0c50-4650-80e6-3c9c38e77d55 0591-0149 HUMAN PRESCRIPTION DRUG Sodium Ferric Gluconate Complex Sodium Ferric Gluconate Complex INJECTION INTRAVENOUS 20110331 ANDA ANDA078215 Actavis Pharma, Inc. SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0591-0240_41c32122-a2f6-4deb-a539-cefbf69bfba7 0591-0240 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072926 Actavis Pharma, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0591-0241_41c32122-a2f6-4deb-a539-cefbf69bfba7 0591-0241 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 Actavis Pharma, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0591-0242_41c32122-a2f6-4deb-a539-cefbf69bfba7 0591-0242 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072928 Actavis Pharma, Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0591-0343_8d5ed236-6a1e-4277-b033-82e9de0aff62 0591-0343 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070995 Actavis Pharma, Inc. VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0591-0345_8d5ed236-6a1e-4277-b033-82e9de0aff62 0591-0345 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 Actavis Pharma, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0591-0347_3f7de35c-7887-4ddb-bec8-cee6a97c9857 0591-0347 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 Actavis Pharma, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0591-0348_4ffe6e02-c27f-448d-b321-a32ab4d68109 0591-0348 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA071851 Actavis Pharma, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0591-0369_d096e64b-b773-4ef8-9cbf-8f0dc02236d8 0591-0369 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072204 Actavis Pharma, Inc. LOXAPINE SUCCINATE 5 mg/1 N 20181231 0591-0370_d096e64b-b773-4ef8-9cbf-8f0dc02236d8 0591-0370 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072205 Actavis Pharma, Inc. LOXAPINE SUCCINATE 10 mg/1 N 20181231 0591-0371_d096e64b-b773-4ef8-9cbf-8f0dc02236d8 0591-0371 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072206 Actavis Pharma, Inc. LOXAPINE SUCCINATE 25 mg/1 N 20181231 0591-0372_d096e64b-b773-4ef8-9cbf-8f0dc02236d8 0591-0372 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072062 Actavis Pharma, Inc. LOXAPINE SUCCINATE 50 mg/1 N 20181231 0591-0395_025d3a30-5810-4df0-a3e7-a95969511b62 0591-0395 HUMAN PRESCRIPTION DRUG Pentazocine and naloxone Pentazocine hydrochloride and naloxone hydrochloride TABLET ORAL 19970521 ANDA ANDA074736 Actavis Pharma, Inc. PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 50; .5 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV N 20181231 0591-0397_16751923-92ec-41d0-9f74-d7d01fcf3b2f 0591-0397 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121101 ANDA ANDA201089 Actavis Pharma, Inc. DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 0591-0398_16751923-92ec-41d0-9f74-d7d01fcf3b2f 0591-0398 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121101 ANDA ANDA201089 Actavis Pharma, Inc. DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 0591-0404_8d5ed236-6a1e-4277-b033-82e9de0aff62 0591-0404 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19930629 ANDA ANDA072924 Actavis Pharma, Inc. VERAPAMIL HYDROCHLORIDE 40 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0591-0405_9d743bf3-9404-4e9f-a24c-3e0475b37e72 0591-0405 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Actavis Pharma, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0591-0406_9d743bf3-9404-4e9f-a24c-3e0475b37e72 0591-0406 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Actavis Pharma, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0591-0407_9d743bf3-9404-4e9f-a24c-3e0475b37e72 0591-0407 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Actavis Pharma, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0591-0408_9d743bf3-9404-4e9f-a24c-3e0475b37e72 0591-0408 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Actavis Pharma, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0591-0409_9d743bf3-9404-4e9f-a24c-3e0475b37e72 0591-0409 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Actavis Pharma, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0591-0410_7a3feb35-7b33-474b-9203-69ab06847494 0591-0410 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20050207 NDA AUTHORIZED GENERIC NDA050641 Actavis Pharma, Inc. DOXYCYCLINE 50 mg/1 N 20181231 0591-0411_7a3feb35-7b33-474b-9203-69ab06847494 0591-0411 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20050207 NDA AUTHORIZED GENERIC NDA050641 Actavis Pharma, Inc. DOXYCYCLINE 100 mg/1 N 20181231 0591-0414_0cd4e8ed-b807-47d4-9926-d22d80ff1c33 0591-0414 HUMAN PRESCRIPTION DRUG Estropipate Estropipate TABLET ORAL 19930923 ANDA ANDA081213 Actavis Pharma, Inc. ESTROPIPATE .75 mg/1 N 20181231 0591-0415_0cd4e8ed-b807-47d4-9926-d22d80ff1c33 0591-0415 HUMAN PRESCRIPTION DRUG Estropipate Estropipate TABLET ORAL 19930923 ANDA ANDA081214 Actavis Pharma, Inc. ESTROPIPATE 1.5 mg/1 N 20181231 0591-0416_0cd4e8ed-b807-47d4-9926-d22d80ff1c33 0591-0416 HUMAN PRESCRIPTION DRUG Estropipate Estropipate TABLET ORAL 19930923 ANDA ANDA081215 Actavis Pharma, Inc. ESTROPIPATE 3 mg/1 N 20181231 0591-0424_4ffe6e02-c27f-448d-b321-a32ab4d68109 0591-0424 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA073449 Actavis Pharma, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0591-0426_16a6aedf-0bb5-493b-ac9e-7146f4ae51fd 0591-0426 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 19950113 ANDA ANDA074060 Watson Laboratories, Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 0591-0444_47afb346-9839-4597-ae9f-730a07a9c841 0591-0444 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 19951017 ANDA ANDA074145 Actavis Pharma, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0591-0453_47afb346-9839-4597-ae9f-730a07a9c841 0591-0453 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 19951017 ANDA ANDA074145 Actavis Pharma, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0591-0460_8bf7f582-46bf-4c4c-92cc-27873c87d20f 0591-0460 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Actavis Pharma, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0591-0461_8bf7f582-46bf-4c4c-92cc-27873c87d20f 0591-0461 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Actavis Pharma, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0591-0462_f7f5221f-4f38-48e8-a4aa-7d9681f1dbe4 0591-0462 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 Actavis Pharma, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0591-0463_f7f5221f-4f38-48e8-a4aa-7d9681f1dbe4 0591-0463 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 Actavis Pharma, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0591-0487_35b5b33c-65a9-45bd-92fe-a4634ea16c02 0591-0487 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Actavis Pharma, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0591-0488_35b5b33c-65a9-45bd-92fe-a4634ea16c02 0591-0488 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Actavis Pharma, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0591-0528_35b5b33c-65a9-45bd-92fe-a4634ea16c02 0591-0528 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Actavis Pharma, Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0591-0582_c6e01387-a042-4c87-83db-9262bea7e999 0591-0582 HUMAN PRESCRIPTION DRUG Propafenone HCl Propafenone hydrochloride TABLET, FILM COATED ORAL 20001024 ANDA ANDA075203 Actavis Pharma, Inc. PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] N 20181231 0591-0583_c6e01387-a042-4c87-83db-9262bea7e999 0591-0583 HUMAN PRESCRIPTION DRUG Propafenone HCl Propafenone hydrochloride TABLET, FILM COATED ORAL 20001024 ANDA ANDA075203 Actavis Pharma, Inc. PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] N 20181231 0591-0605_3e789b1e-2def-442c-833c-f0c260852bb3 0591-0605 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Actavis Pharma, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0591-0606_3e789b1e-2def-442c-833c-f0c260852bb3 0591-0606 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Actavis Pharma, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0591-0607_3e789b1e-2def-442c-833c-f0c260852bb3 0591-0607 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Actavis Pharma, Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0591-0657_71a042fc-d5d4-4190-b309-81bc1b95be02 0591-0657 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 20181231 ANDA ANDA074253 Actavis Pharma, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20191231 0591-0658_71a042fc-d5d4-4190-b309-81bc1b95be02 0591-0658 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 20190331 ANDA ANDA074253 Actavis Pharma, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20191231 0591-0676_c0349b9e-b614-4a9e-9cb0-8e9992d340e4 0591-0676 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021106 ANDA ANDA076201 Actavis Pharma, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0591-0718_71a042fc-d5d4-4190-b309-81bc1b95be02 0591-0718 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20020313 20190331 ANDA ANDA074253 Actavis Pharma, Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20191231 0591-0744_100e2435-e992-4c07-a770-d86ac5efe0c0 0591-0744 HUMAN PRESCRIPTION DRUG Estazolam Estazolam TABLET ORAL 19971001 ANDA ANDA074818 Actavis Pharma, Inc. ESTAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0591-0745_100e2435-e992-4c07-a770-d86ac5efe0c0 0591-0745 HUMAN PRESCRIPTION DRUG Estazolam Estazolam TABLET ORAL 19971001 ANDA ANDA074818 Actavis Pharma, Inc. ESTAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0591-0780_e1dabe8a-41e6-4d91-8051-a8d0557f9834 0591-0780 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961101 20200331 NDA AUTHORIZED GENERIC NDA018333 Actavis Pharma, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 0591-0781_0151a977-c309-4653-bad4-9def75862f1e 0591-0781 HUMAN PRESCRIPTION DRUG Clomiphene Citrate Clomiphene Citrate TABLET ORAL 19901001 20180630 NDA NDA016131 Actavis Pharma, Inc. CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20191231 0591-0782_ea48e26c-bc0f-4834-b60a-525a1f9b4647 0591-0782 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 19601117 NDA NDA012546 Actavis Pharma, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0591-0783_ea48e26c-bc0f-4834-b60a-525a1f9b4647 0591-0783 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 19590806 NDA NDA011722 Actavis Pharma, Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 0591-0790_92df17fa-33bb-4cfe-bfdb-dd2848fb4015 0591-0790 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20160526 ANDA ANDA040232 Actavis Pharma, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0591-0794_5357bfc6-3362-4588-aad3-37e421d959ee 0591-0794 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 Actavis Pharma, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0591-0795_5357bfc6-3362-4588-aad3-37e421d959ee 0591-0795 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 Actavis Pharma, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0591-0796_75c7b76e-187b-4179-b784-f0652e1ed0b3 0591-0796 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 19821001 ANDA ANDA085828 Actavis Pharma, Inc. SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0591-0800_1916ebeb-20e2-401a-b32c-62ce8627ba8a 0591-0800 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Actavis Pharma, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0591-0801_1916ebeb-20e2-401a-b32c-62ce8627ba8a 0591-0801 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960615 ANDA ANDA040156 Actavis Pharma, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0591-0810_866ab234-aa3d-47fe-85a6-84b0339f8dbb 0591-0810 HUMAN PRESCRIPTION DRUG Silver Sulfadiazene Silver Sulfadiazine CREAM TOPICAL 19820225 NDA NDA018578 Actavis Pharma, Inc. SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 0591-0844_3d5f3117-24e2-4719-a762-b81615b8c8c4 0591-0844 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031119 ANDA ANDA076467 Actavis Pharma, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0591-0845_3d5f3117-24e2-4719-a762-b81615b8c8c4 0591-0845 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031119 ANDA ANDA076467 Actavis Pharma, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0591-0860_e1f597dc-6476-4161-b3e3-efef70669085 0591-0860 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA076194 Actavis Pharma, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0591-0861_e1f597dc-6476-4161-b3e3-efef70669085 0591-0861 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20030304 ANDA ANDA076194 Actavis Pharma, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0591-0862_e1f597dc-6476-4161-b3e3-efef70669085 0591-0862 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20030304 ANDA ANDA076194 Actavis Pharma, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0591-0885_9d743bf3-9404-4e9f-a24c-3e0475b37e72 0591-0885 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Actavis Pharma, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0591-0900_3d5f3117-24e2-4719-a762-b81615b8c8c4 0591-0900 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060403 ANDA ANDA076467 Actavis Pharma, Inc. GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0591-1117_29e37ef4-ecc0-46fb-a495-aa77b9d6509d 0591-1117 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Actavis Pharma, Inc. MIRTAZAPINE 15 mg/1 N 20181231 0591-1118_29e37ef4-ecc0-46fb-a495-aa77b9d6509d 0591-1118 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Actavis Pharma, Inc. MIRTAZAPINE 30 mg/1 N 20181231 0591-1119_29e37ef4-ecc0-46fb-a495-aa77b9d6509d 0591-1119 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Actavis Pharma, Inc. MIRTAZAPINE 45 mg/1 N 20181231 0591-1159_a11515dc-17ad-4cef-a9c6-8a3a750fe185 0591-1159 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir OINTMENT TOPICAL 20140411 NDA AUTHORIZED GENERIC NDA018604 Actavis Pharma, Inc. ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0591-2044_7a248a22-542a-4581-8b00-1f87a2febea5 0591-2044 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140611 NDA AUTHORIZED GENERIC NDA020835 Actavis Pharma, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 129; 21 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0591-2067_7a248a22-542a-4581-8b00-1f87a2febea5 0591-2067 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140627 NDA AUTHORIZED GENERIC NDA020835 Actavis Pharma, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 64.5; 10.5 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0591-2070_e885b52f-3acc-45b9-8a44-4c6e675150b5 0591-2070 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine lidocaine and prilocaine CREAM TOPICAL 20121112 NDA AUTHORIZED GENERIC NDA019941 Actavis Pharma, Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0591-2075_7a248a22-542a-4581-8b00-1f87a2febea5 0591-2075 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140627 NDA AUTHORIZED GENERIC NDA020835 Actavis Pharma, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 30.1; 4.9 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0591-2102_7a248a22-542a-4581-8b00-1f87a2febea5 0591-2102 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140627 NDA AUTHORIZED GENERIC NDA020835 Actavis Pharma, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 4.3; .7 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0591-2109_7a248a22-542a-4581-8b00-1f87a2febea5 0591-2109 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140627 NDA AUTHORIZED GENERIC NDA020835 Actavis Pharma, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 25.8; 4.2 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0591-2114_9273be5e-32f2-4c3f-a477-670a612aa93a 0591-2114 HUMAN PRESCRIPTION DRUG Testosterone Testosterone SOLUTION TOPICAL 20170818 ANDA ANDA205328 Actavis Pharma, Inc. TESTOSTERONE 30 mg/1.5mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0591-2136_e49a578a-5ee1-4160-8657-92767d76cffa 0591-2136 HUMAN PRESCRIPTION DRUG Propofol Propofol INJECTION, EMULSION INTRAVENOUS 20160107 ANDA ANDA205307 Actavis Pharma, Inc. PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 0591-2140_4ded993f-0a1f-46ac-b92a-6db66962b2d5 0591-2140 HUMAN PRESCRIPTION DRUG Diclofenac sodium Diclofenac sodium SOLUTION TOPICAL 20150406 ANDA ANDA202852 Actavis Pharma, Inc. DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0591-2157_df534055-c02c-41e9-a81c-72ed70eff9e4 0591-2157 HUMAN PRESCRIPTION DRUG AMMONIUM LACTATE AMMONIUM LACTATE CREAM TOPICAL 20120605 ANDA ANDA075774 Watson Laboratories, Inc. AMMONIUM LACTATE 12 g/100g N 20181231 0591-2158_08a1e7fb-3d1d-462f-ae8e-299f4733cfc5 0591-2158 HUMAN PRESCRIPTION DRUG Ammonium Lactate Ammonium Lactate LOTION TOPICAL 20120605 ANDA ANDA075570 Watson Laboratories, Inc. AMMONIUM LACTATE 12 g/100g N 20181231 0591-2159_58c2fdd4-7489-47d9-9213-8f85b504b0c0 0591-2159 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SHAMPOO TOPICAL 20121212 ANDA ANDA090490 Actavis Pharma, Inc. CICLOPIROX 10 mg/.96mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 0591-2167_811d1dd9-fc06-4bef-8e5b-538956291c78 0591-2167 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA090642 Actavis Pharma, Inc. VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0591-2168_811d1dd9-fc06-4bef-8e5b-538956291c78 0591-2168 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA090642 Actavis Pharma, Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0591-2169_811d1dd9-fc06-4bef-8e5b-538956291c78 0591-2169 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA090642 Actavis Pharma, Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0591-2170_811d1dd9-fc06-4bef-8e5b-538956291c78 0591-2170 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA090642 Actavis Pharma, Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0591-2171_e981a684-cf7e-41f6-8788-2a571881e0ef 0591-2171 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141118 ANDA ANDA040148 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0591-2172_e981a684-cf7e-41f6-8788-2a571881e0ef 0591-2172 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160526 ANDA ANDA040148 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0591-2174_b727c3d1-a826-4d02-bea8-0abf6dba9855 0591-2174 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20160728 ANDA ANDA206470 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0591-2175_b727c3d1-a826-4d02-bea8-0abf6dba9855 0591-2175 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20160728 ANDA ANDA206470 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0591-2176_b727c3d1-a826-4d02-bea8-0abf6dba9855 0591-2176 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20160728 ANDA ANDA206470 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0591-2190_54271419-473c-425b-b5da-14009afcd2fa 0591-2190 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates Neomycin and Polymyxin B Sulfates IRRIGANT IRRIGATION 20101025 ANDA ANDA062664 Actavis Pharma, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE 40; 200000 mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 0591-2222_c4cfcf36-a22d-4304-9900-c662e1e07ac0 0591-2222 HUMAN PRESCRIPTION DRUG CycloSPORINE CycloSPORINE CAPSULE, LIQUID FILLED ORAL 20081201 ANDA ANDA065044 Actavis Pharma, Inc. CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0591-2223_c4cfcf36-a22d-4304-9900-c662e1e07ac0 0591-2223 HUMAN PRESCRIPTION DRUG CycloSPORINE CycloSPORINE CAPSULE, LIQUID FILLED ORAL 20081201 ANDA ANDA065044 Actavis Pharma, Inc. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0591-2224_c4cfcf36-a22d-4304-9900-c662e1e07ac0 0591-2224 HUMAN PRESCRIPTION DRUG CycloSPORINE CycloSPORINE SOLUTION ORAL 20081201 ANDA ANDA065054 Actavis Pharma, Inc. CYCLOSPORINE 100 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0591-2263_05d0e3d1-fe9a-442d-b3dd-683e723135bf 0591-2263 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20160211 20180531 ANDA ANDA202552 Actavis Pharma, Inc. ACITRETIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0591-2264_05d0e3d1-fe9a-442d-b3dd-683e723135bf 0591-2264 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20160321 20180531 ANDA ANDA202552 Actavis Pharma, Inc. ACITRETIN 17.5 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0591-2266_05d0e3d1-fe9a-442d-b3dd-683e723135bf 0591-2266 HUMAN PRESCRIPTION DRUG Acitretin Acitretin CAPSULE ORAL 20160112 20180531 ANDA ANDA202552 Actavis Pharma, Inc. ACITRETIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0591-2281_7be9addd-3cd3-4180-9593-6b9dc11d4a6b 0591-2281 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130325 ANDA ANDA090153 Actavis Pharma, Inc. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0591-2282_7be9addd-3cd3-4180-9593-6b9dc11d4a6b 0591-2282 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130325 ANDA ANDA090153 Actavis Pharma, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0591-2285_9e8d630e-5cb7-4e91-a8ba-1a47934016f0 0591-2285 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20151015 ANDA ANDA202688 Actavis Pharma, Inc. PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] N 20181231 0591-2286_9e8d630e-5cb7-4e91-a8ba-1a47934016f0 0591-2286 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20151015 ANDA ANDA202688 Actavis Pharma, Inc. PROPAFENONE HYDROCHLORIDE 325 mg/1 Antiarrhythmic [EPC] N 20181231 0591-2287_9e8d630e-5cb7-4e91-a8ba-1a47934016f0 0591-2287 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20151015 ANDA ANDA202688 Actavis Pharma, Inc. PROPAFENONE HYDROCHLORIDE 425 mg/1 Antiarrhythmic [EPC] N 20181231 0591-2292_283c4cc5-3dfc-410a-b2a2-84588b155dcc 0591-2292 HUMAN PRESCRIPTION DRUG Dutasteride Dutasteride CAPSULE ORAL 20151120 ANDA ANDA202808 Actavis Pharma, Inc. DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 0591-2315_654be6e3-2b8a-439d-ba04-401f0610d263 0591-2315 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA091519 Actavis Pharma, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0591-2316_654be6e3-2b8a-439d-ba04-401f0610d263 0591-2316 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA091519 Actavis Pharma, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0591-2317_654be6e3-2b8a-439d-ba04-401f0610d263 0591-2317 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA091519 Actavis Pharma, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0591-2318_654be6e3-2b8a-439d-ba04-401f0610d263 0591-2318 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA091519 Actavis Pharma, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0591-2319_654be6e3-2b8a-439d-ba04-401f0610d263 0591-2319 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA091519 Actavis Pharma, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0591-2341_30a1eb02-6adf-4e9e-91d8-d60d6df82ce9 0591-2341 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20170619 ANDA ANDA203695 Actavis Pharma, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 0591-2367_bb127fe1-dc9a-46fb-ac3e-87a5ba96f656 0591-2367 HUMAN PRESCRIPTION DRUG Raloxifene Raloxifene hydrochloride TABLET, FILM COATED ORAL 20150618 ANDA ANDA200825 Actavis Pharma, Inc. RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0591-2368_53372d83-ff6f-4f84-ad18-9212b5b36d34 0591-2368 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20111223 ANDA ANDA200826 Actavis Pharma, Inc. URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 0591-2369_53372d83-ff6f-4f84-ad18-9212b5b36d34 0591-2369 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20111223 ANDA ANDA200826 Actavis Pharma, Inc. URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 0591-2404_7a3feb35-7b33-474b-9203-69ab06847494 0591-2404 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20110207 NDA AUTHORIZED GENERIC NDA050641 Actavis Pharma, Inc. DOXYCYCLINE 75 mg/1 N 20181231 0591-2411_844c3567-c359-4f96-9adb-2fb48f0f965f 0591-2411 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170515 ANDA ANDA203755 Actavis Pharma, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0591-2412_844c3567-c359-4f96-9adb-2fb48f0f965f 0591-2412 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170515 ANDA ANDA203755 Actavis Pharma, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0591-2448_91629ecf-4480-4aec-ae36-5718ec8c35ae 0591-2448 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20160113 ANDA ANDA203306 Actavis Pharma, Inc. LANSOPRAZOLE 15 mg/1 N 20181231 0591-2464_a4091fa6-ac7b-440f-8286-46df62b02e5e 0591-2464 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20110815 ANDA ANDA076470 Actavis Pharma, Inc. DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 0591-2465_a4091fa6-ac7b-440f-8286-46df62b02e5e 0591-2465 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20110815 ANDA ANDA076470 Actavis Pharma, Inc. DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 0591-2466_98bf306e-5ac1-4ddc-927c-951b1aa3aa83 0591-2466 HUMAN PRESCRIPTION DRUG Flutamide Flutamide CAPSULE ORAL 20110728 ANDA ANDA075820 Actavis Pharma, Inc. FLUTAMIDE 125 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 0591-2467_3f9129f3-fbe1-4a95-8c95-7862d4bd9ce0 0591-2467 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA072750 Actavis Pharma, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0591-2468_3f9129f3-fbe1-4a95-8c95-7862d4bd9ce0 0591-2468 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 Actavis Pharma, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0591-2469_cc2ee78a-3f59-4e86-b3bb-fe0aa539739e 0591-2469 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20140211 ANDA ANDA076307 Actavis Pharma, Inc. MIRTAZAPINE 15 mg/1 N 20181231 0591-2470_cc2ee78a-3f59-4e86-b3bb-fe0aa539739e 0591-2470 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20140211 ANDA ANDA076307 Actavis Pharma, Inc. MIRTAZAPINE 30 mg/1 N 20181231 0591-2471_cc2ee78a-3f59-4e86-b3bb-fe0aa539739e 0591-2471 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20111001 ANDA ANDA076307 Actavis Pharma, Inc. MIRTAZAPINE 45 mg/1 N 20181231 0591-2472_9edb57a6-23a2-4fb2-bf7f-a08dc06624c4 0591-2472 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20110815 ANDA ANDA070929 Actavis Pharma, Inc. TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0591-2473_9edb57a6-23a2-4fb2-bf7f-a08dc06624c4 0591-2473 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20110815 ANDA ANDA070929 Actavis Pharma, Inc. TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 0591-2474_5f733be9-db63-45c3-9468-742bb15d13f3 0591-2474 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20110815 ANDA ANDA061837 Actavis Pharma, Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0591-2475_5f733be9-db63-45c3-9468-742bb15d13f3 0591-2475 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20110815 ANDA ANDA061837 Actavis Pharma, Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0591-2481_3ff594dd-b9d6-4206-954a-5a90bbfdefee 0591-2481 HUMAN PRESCRIPTION DRUG Dorzolamide HCl Dorzolamide Hydrochloride SOLUTION OPHTHALMIC 20150217 ANDA ANDA202053 Actavis Pharma, Inc. DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] N 20181231 0591-2482_0b87f210-22b7-4cf0-b39a-9cc1320e0b25 0591-2482 HUMAN PRESCRIPTION DRUG Dorzolamide HCl and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION OPHTHALMIC 20150217 ANDA ANDA202054 Actavis Pharma, Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0591-2508_08bd1969-3fde-4ead-8e07-9dbf077447e4 0591-2508 HUMAN PRESCRIPTION DRUG Sodium Ferric Gluconate Complex in Sucrose Sodium Ferric Gluconate Complex INJECTION INTRAVENOUS 20120823 ANDA ANDA078215 Actavis Pharma, Inc. SODIUM FERRIC GLUCONATE COMPLEX 12.5 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0591-2520_fbf8dd6b-2948-4373-8f57-e21a329f81ab 0591-2520 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 Actavis Pharma, Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0591-2521_d5faaf0d-ebf2-4a27-84a6-fe3719bfdef6 0591-2521 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20111117 ANDA ANDA070035 Actavis Pharma, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20191231 0591-2528_2290ded2-c51c-43bd-981b-a55d1f2c0c15 0591-2528 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20151222 ANDA ANDA203807 Actavis Pharma, Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0591-2529_2290ded2-c51c-43bd-981b-a55d1f2c0c15 0591-2529 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20151222 ANDA ANDA203807 Actavis Pharma, Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0591-2579_be82ea85-904e-4167-b081-d256df64c1cf 0591-2579 HUMAN PRESCRIPTION DRUG Valganciclovir hydrochloride for Oral Valganciclovir hydrochloride POWDER, FOR SOLUTION ORAL 20160826 ANDA ANDA205220 Actavis Pharma, Inc. VALGANCICLOVIR HYDROCHLORIDE 50 mg/mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 0591-2605_e981a684-cf7e-41f6-8788-2a571881e0ef 0591-2605 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130314 ANDA ANDA040148 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0591-2612_e981a684-cf7e-41f6-8788-2a571881e0ef 0591-2612 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130307 ANDA ANDA040148 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0591-2640_0396be1a-8177-4c0c-a635-49d5523843c5 0591-2640 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine CAPSULE ORAL 20130729 ANDA ANDA040885 Actavis Pharma, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 300; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20191231 0591-2641_5cbba5c1-e037-46bf-a4ed-6cc01c5154da 0591-2641 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20130729 ANDA ANDA076560 Actavis Pharma, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE 50; 300; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0591-2693_d7c03c97-505c-4ec9-ab36-365102b3eda9 0591-2693 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140903 NDA AUTHORIZED GENERIC NDA022272 Actavis Pharma, Inc. OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-2708_d7c03c97-505c-4ec9-ab36-365102b3eda9 0591-2708 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140903 NDA AUTHORIZED GENERIC NDA022272 Actavis Pharma, Inc. OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-2715_2e3d97ca-a17a-46bd-bd6c-dafbbbab1f4a 0591-2715 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20110401 NDA AUTHORIZED GENERIC NDA021121 Actavis Pharma, Inc. METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0591-2716_2e3d97ca-a17a-46bd-bd6c-dafbbbab1f4a 0591-2716 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20110401 NDA AUTHORIZED GENERIC NDA021121 Actavis Pharma, Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0591-2717_2e3d97ca-a17a-46bd-bd6c-dafbbbab1f4a 0591-2717 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20110401 NDA AUTHORIZED GENERIC NDA021121 Actavis Pharma, Inc. METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0591-2718_2e3d97ca-a17a-46bd-bd6c-dafbbbab1f4a 0591-2718 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20110401 NDA AUTHORIZED GENERIC NDA021121 Actavis Pharma, Inc. METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0591-2719_a650ebe1-bfe7-406d-af68-cefbb8c257d4 0591-2719 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120418 NDA AUTHORIZED GENERIC NDA021574 Actavis Pharma, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0591-2720_a650ebe1-bfe7-406d-af68-cefbb8c257d4 0591-2720 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120418 NDA AUTHORIZED GENERIC NDA021574 Actavis Pharma, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0591-2736_ef253998-d6d0-468b-b77c-35a122b6aab9 0591-2736 HUMAN PRESCRIPTION DRUG levalbuterol hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20140610 ANDA ANDA077756 Actavis Pharma, Inc. LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0591-2737_ef253998-d6d0-468b-b77c-35a122b6aab9 0591-2737 HUMAN PRESCRIPTION DRUG levalbuterol hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20140610 ANDA ANDA077756 Actavis Pharma, Inc. LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0591-2738_ef253998-d6d0-468b-b77c-35a122b6aab9 0591-2738 HUMAN PRESCRIPTION DRUG levalbuterol hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20140610 ANDA ANDA077756 Actavis Pharma, Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0591-2788_27de8563-dca6-44bb-b0a1-85f0454c0821 0591-2788 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 NDA NDA021447 Actavis Pharma, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0591-2789_27de8563-dca6-44bb-b0a1-85f0454c0821 0591-2789 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 NDA NDA021447 Actavis Pharma, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0591-2790_27de8563-dca6-44bb-b0a1-85f0454c0821 0591-2790 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 NDA NDA021447 Actavis Pharma, Inc. TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0591-2805_79db5226-6f5a-49de-80ab-411ff83ab6bb 0591-2805 HUMAN PRESCRIPTION DRUG clarithromycin clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140227 ANDA ANDA065145 Actavis Pharma, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0591-2820_b727047e-cb97-4ecb-ad09-ca03f4021a33 0591-2820 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 20180531 NDA AUTHORIZED GENERIC NDA020998 Actavis Pharma, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0591-2825_b727047e-cb97-4ecb-ad09-ca03f4021a33 0591-2825 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 20180430 NDA AUTHORIZED GENERIC NDA020998 Actavis Pharma, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0591-2880_c247566a-4c1c-45b8-b7e5-fd33859eaeb5 0591-2880 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Actavis Pharma, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0591-2882_c247566a-4c1c-45b8-b7e5-fd33859eaeb5 0591-2882 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Actavis Pharma, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0591-2884_c247566a-4c1c-45b8-b7e5-fd33859eaeb5 0591-2884 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Actavis Pharma, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0591-2886_c247566a-4c1c-45b8-b7e5-fd33859eaeb5 0591-2886 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Actavis Pharma, Inc. VERAPAMIL HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0591-2888_72f82956-ab4c-41f3-9a3e-ff39ccfb7f5a 0591-2888 HUMAN PRESCRIPTION DRUG Hydroxocobalamin Hydroxocobalamin INJECTION, SOLUTION INTRAMUSCULAR 20101112 ANDA ANDA085998 Actavis Pharma, Inc. HYDROXOCOBALAMIN ACETATE 1000 ug/mL Antidote [EPC] N 20181231 0591-2897_ba887c6a-ff20-4683-b210-c673928060b8 0591-2897 HUMAN PRESCRIPTION DRUG Azacitidine Azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20160922 NDA NDA208216 Actavis Pharma, Inc. AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0591-2921_c18dc71a-0f59-47c3-a131-7eb6cc8fe23a 0591-2921 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL TOPICAL 20151214 ANDA ANDA076737 Actavis Pharma, Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0591-2927_8d1ddc6b-a1b5-41dc-9ee5-ee577ad62144 0591-2927 HUMAN PRESCRIPTION DRUG Levalbuterol tartrate HFA inhalation levalbuterol tartrate AEROSOL, METERED ORAL 20161003 NDA AUTHORIZED GENERIC NDA021730 Actavis Pharma, Inc. LEVALBUTEROL TARTRATE 45 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 0591-2932_f3c03f1c-fc3a-4d67-a0f0-791918955623 0591-2932 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140909 ANDA ANDA063083 Actavis Pharma, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0591-2985_ab30ea9f-1b34-47f9-adbf-7556eff37825 0591-2985 HUMAN PRESCRIPTION DRUG PHENADOZ Promethazine Hydrochloride SUPPOSITORY RECTAL 20150316 ANDA ANDA040428 Actavis Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0591-2990_c2fa39f0-85ee-4bb4-b709-27f51796a393 0591-2990 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Topical Fluocinolone Acetonide Topical SOLUTION TOPICAL 20161207 ANDA ANDA208386 Actavis Pharma, Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0591-2992_ab30ea9f-1b34-47f9-adbf-7556eff37825 0591-2992 HUMAN PRESCRIPTION DRUG PHENADOZ Promethazine Hydrochloride SUPPOSITORY RECTAL 20150217 ANDA ANDA040428 Actavis Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0591-2998_17a5c36f-f0fa-4f33-b9a5-5e26f17bd6a5 0591-2998 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET ORAL 19971210 NDA AUTHORIZED GENERIC NDA020675 Actavis Pharma, Inc. URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 0591-3005_17a5c36f-f0fa-4f33-b9a5-5e26f17bd6a5 0591-3005 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET ORAL 19971210 NDA AUTHORIZED GENERIC NDA020675 Actavis Pharma, Inc. URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 0591-3011_8bfb83c3-e896-456f-a95d-a56e97d5e906 0591-3011 HUMAN PRESCRIPTION DRUG memantine hydrochloride memantine hydrochloride SOLUTION ORAL 20150401 NDA NDA021487 Actavis Pharma, Inc MEMANTINE HYDROCHLORIDE 2 mg/mL NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 0591-3012_876d6327-3c2c-42bc-bc7d-33a45d549b91 0591-3012 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride JELLY TOPICAL 20150615 ANDA ANDA040837 Actavis Pharma, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0591-3041_c9d3ac7a-3325-4ec4-9a8e-be7188d186d4 0591-3041 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20160330 ANDA ANDA040133 Actavis Pharma, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 0591-3128_639ed3f2-0c98-4b40-8f7e-f164d2ac2fa7 0591-3128 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE INJECTION, SOLUTION INTRAMUSCULAR 19780511 NDA NDA017362 Actavis Pharma, Inc. PROGESTERONE 50 mg/mL Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 0591-3137_7d05b7ea-69d2-4c06-b985-762f2684798e 0591-3137 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 Actavis Pharma, Inc. NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0591-3138_7d05b7ea-69d2-4c06-b985-762f2684798e 0591-3138 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 Actavis Pharma, Inc. NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0591-3153_54e21205-366f-47ac-a758-7d6dcd07782c 0591-3153 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20020917 ANDA ANDA063065 Actavis Pharma, Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0591-3159_500fe328-06de-4158-9229-517cfd30f1c6 0591-3159 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 19871231 NDA AUTHORIZED GENERIC NDA019594 Actavis Pharma, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 0591-3169_ab66c2e4-ca55-4e7a-a30e-ab5fd970398f 0591-3169 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA076768 Actavis Pharma, Inc. ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0591-3170_ab66c2e4-ca55-4e7a-a30e-ab5fd970398f 0591-3170 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA076768 Actavis Pharma, Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0591-3171_ab66c2e4-ca55-4e7a-a30e-ab5fd970398f 0591-3171 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA076768 Actavis Pharma, Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0591-3172_ab66c2e4-ca55-4e7a-a30e-ab5fd970398f 0591-3172 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA076768 Actavis Pharma, Inc. ALENDRONATE SODIUM 40 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0591-3173_ab66c2e4-ca55-4e7a-a30e-ab5fd970398f 0591-3173 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA076768 Actavis Pharma, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0591-3193_713d36fd-1843-4eb7-80cf-c8a640c181ed 0591-3193 HUMAN PRESCRIPTION DRUG Afeditab CR Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021101 ANDA ANDA075128 Actavis Pharma, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0591-3194_713d36fd-1843-4eb7-80cf-c8a640c181ed 0591-3194 HUMAN PRESCRIPTION DRUG Afeditab CR Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021101 ANDA ANDA075659 Actavis Pharma, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0591-3196_f0617705-38d2-460b-a329-e916ca655e33 0591-3196 HUMAN PRESCRIPTION DRUG TERCONAZOLE TERCONAZOLE CREAM VAGINAL 20040401 NDA AUTHORIZED GENERIC NDA019579 Actavis Pharma, Inc TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0591-3197_f0617705-38d2-460b-a329-e916ca655e33 0591-3197 HUMAN PRESCRIPTION DRUG TERCONAZOLE TERCONAZOLE CREAM VAGINAL 20040401 NDA AUTHORIZED GENERIC NDA019964 Actavis Pharma, Inc TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0591-3198_896ff514-8b5f-4b02-80d8-96b603ed6845 0591-3198 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Actavis Pharma, Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3202_6ede15a7-7832-456f-b3f4-3e5bf4f5c9e8 0591-3202 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen Hydrocodone Bitartate and Acetaminophen TABLET ORAL 20030224 20190131 ANDA ANDA040099 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0591-3204_ac1ad39a-ecdf-419e-830b-c1727a7514a9 0591-3204 HUMAN PRESCRIPTION DRUG Podofilox Podofilox SOLUTION TOPICAL 19901213 NDA AUTHORIZED GENERIC NDA019795 Actavis Pharma, Inc. PODOFILOX 5 mg/mL Decreased Mitosis [PE] N 20181231 0591-3205_beb8ba88-e77c-44a0-9ba0-c46866e15091 0591-3205 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20121026 ANDA ANDA076798 Actavis Pharma, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 0591-3206_beb8ba88-e77c-44a0-9ba0-c46866e15091 0591-3206 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20121026 ANDA ANDA076798 Actavis Pharma, Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 0591-3207_beb8ba88-e77c-44a0-9ba0-c46866e15091 0591-3207 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20121026 ANDA ANDA076798 Actavis Pharma, Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 0591-3208_a4e0cc73-97ba-4efc-8862-d054c1b6eca4 0591-3208 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077129 Actavis Pharma, Inc. RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0591-3209_a4e0cc73-97ba-4efc-8862-d054c1b6eca4 0591-3209 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077129 Actavis Pharma, Inc. RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0591-3210_a4e0cc73-97ba-4efc-8862-d054c1b6eca4 0591-3210 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077129 Actavis Pharma, Inc. RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0591-3211_a4e0cc73-97ba-4efc-8862-d054c1b6eca4 0591-3211 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077129 Actavis Pharma, Inc. RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0591-3212_896ff514-8b5f-4b02-80d8-96b603ed6845 0591-3212 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Actavis Pharma, Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3213_896ff514-8b5f-4b02-80d8-96b603ed6845 0591-3213 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Actavis Pharma, Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3214_896ff514-8b5f-4b02-80d8-96b603ed6845 0591-3214 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Actavis Pharma, Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3216_c18dc71a-0f59-47c3-a131-7eb6cc8fe23a 0591-3216 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL TOPICAL 20151204 ANDA ANDA076737 Actavis Pharma, Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0591-3217_c18dc71a-0f59-47c3-a131-7eb6cc8fe23a 0591-3217 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL TOPICAL 20151204 ANDA ANDA076737 Actavis Pharma, Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0591-3219_10523773-dbe4-4d10-818d-fe2794dbd31f 0591-3219 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, and Caffeine butalbital, aspirin, and caffeine CAPSULE ORAL 20031006 NDA AUTHORIZED GENERIC NDA017534 Actavis Pharma, Inc. BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 0591-3220_d2127a92-427c-4c7e-96a7-decb6c1c25c8 0591-3220 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20030918 NDA AUTHORIZED GENERIC NDA020232 Actavis Pharma, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0591-3221_4847dc32-e00f-4190-b430-b3df89f80f79 0591-3221 HUMAN PRESCRIPTION DRUG Testosterone Enanthate Testosterone Enanthate INJECTION, SOLUTION INTRAMUSCULAR 19900903 ANDA ANDA085598 Actavis Pharma, Inc. TESTOSTERONE ENANTHATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0591-3222_39c38f33-5b9a-45d3-af39-b9542bbb8c18 0591-3222 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 20100708 ANDA ANDA084779 Actavis Pharma, Inc. ORPHENADRINE CITRATE 30 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0591-3248_8c5efdea-c4b9-440e-95f8-95ca9bd0501e 0591-3248 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA077135 Actavis Pharma, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0591-3249_8c5efdea-c4b9-440e-95f8-95ca9bd0501e 0591-3249 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA077135 Actavis Pharma, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0591-3256_2676e20d-0030-42ec-8d88-79c3c40fe9ba 0591-3256 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20060203 ANDA ANDA071611 Actavis Pharma, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0591-3271_6a4a7cd7-28e9-4381-a27d-badb5d5083d8 0591-3271 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA078278 Actavis Pharma, Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0591-3272_6a4a7cd7-28e9-4381-a27d-badb5d5083d8 0591-3272 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA078278 Actavis Pharma, Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0591-3273_6a4a7cd7-28e9-4381-a27d-badb5d5083d8 0591-3273 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA078278 Actavis Pharma, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0591-3292_d1d1de1c-f5fc-4745-8f04-73f00db617d8 0591-3292 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20140108 ANDA ANDA078710 Actavis Pharma, Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0591-3293_d1d1de1c-f5fc-4745-8f04-73f00db617d8 0591-3293 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20140108 ANDA ANDA078710 Actavis Pharma, Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0591-3294_d1d1de1c-f5fc-4745-8f04-73f00db617d8 0591-3294 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20140108 ANDA ANDA078710 Actavis Pharma, Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0591-3330_2676e20d-0030-42ec-8d88-79c3c40fe9ba 0591-3330 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20060203 ANDA ANDA071611 Actavis Pharma, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0591-3331_4493faf6-f362-4d54-a099-3d574ecdbcd6 0591-3331 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081126 ANDA ANDA077715 Actavis Pharma, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0591-3354_1c803a85-66c4-410e-abb3-1585a2b0964d 0591-3354 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET ORAL 20110518 ANDA ANDA077462 Actavis Pharma, Inc. NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0591-3355_1c803a85-66c4-410e-abb3-1585a2b0964d 0591-3355 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET ORAL 20110518 ANDA ANDA077462 Actavis Pharma, Inc. NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0591-3369_6058aebb-772b-4e39-8626-9d435e4a6a2e 0591-3369 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20071213 ANDA ANDA088616 Actavis Pharma, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0591-3449_6e1cb452-4764-4040-b6f0-b312ff686f39 0591-3449 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Watson Laboratories, Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3450_6e1cb452-4764-4040-b6f0-b312ff686f39 0591-3450 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Watson Laboratories, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3451_6e1cb452-4764-4040-b6f0-b312ff686f39 0591-3451 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Watson Laboratories, Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3452_6e1cb452-4764-4040-b6f0-b312ff686f39 0591-3452 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Watson Laboratories, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3453_6e1cb452-4764-4040-b6f0-b312ff686f39 0591-3453 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Watson Laboratories, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3467_b2d0d0ec-71d4-41c4-8403-52487c9a73b8 0591-3467 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20070925 ANDA ANDA077772 Actavis Pharma, Inc. ALBUTEROL SULFATE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0591-3468_b2d0d0ec-71d4-41c4-8403-52487c9a73b8 0591-3468 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20070925 ANDA ANDA077772 Actavis Pharma, Inc. ALBUTEROL SULFATE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0591-3496_5a570f5c-e48c-4238-ae28-108ad86a54cf 0591-3496 HUMAN PRESCRIPTION DRUG Galantamine Galantamine CAPSULE, EXTENDED RELEASE ORAL 20081215 ANDA ANDA079028 Actavis Pharma, Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0591-3497_5a570f5c-e48c-4238-ae28-108ad86a54cf 0591-3497 HUMAN PRESCRIPTION DRUG Galantamine Galantamine CAPSULE, EXTENDED RELEASE ORAL 20081215 ANDA ANDA079028 Actavis Pharma, Inc. GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0591-3498_5a570f5c-e48c-4238-ae28-108ad86a54cf 0591-3498 HUMAN PRESCRIPTION DRUG Galantamine Galantamine CAPSULE, EXTENDED RELEASE ORAL 20081215 ANDA ANDA079028 Actavis Pharma, Inc. GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0591-3499_a81c9731-0641-4601-b50e-cfcbf73b70e0 0591-3499 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130403 ANDA ANDA076715 Actavis Pharma, Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 0591-3500_a81c9731-0641-4601-b50e-cfcbf73b70e0 0591-3500 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130403 ANDA ANDA076715 Actavis Pharma, Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 0591-3508_7c40121c-8149-4608-8874-8bd5878a7132 0591-3508 HUMAN PRESCRIPTION DRUG Clonidine transdermal system Clonidine PATCH TRANSDERMAL 20140506 ANDA ANDA090873 Actavis Pharma, Inc. CLONIDINE .1 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0591-3509_7c40121c-8149-4608-8874-8bd5878a7132 0591-3509 HUMAN PRESCRIPTION DRUG Clonidine transdermal system Clonidine PATCH TRANSDERMAL 20140506 ANDA ANDA090873 Actavis Pharma, Inc. CLONIDINE .2 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0591-3510_7c40121c-8149-4608-8874-8bd5878a7132 0591-3510 HUMAN PRESCRIPTION DRUG Clonidine transdermal system Clonidine PATCH TRANSDERMAL 20140506 ANDA ANDA090873 Actavis Pharma, Inc. CLONIDINE .3 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0591-3524_35c991bd-ea12-43ec-8b4b-d0bcaa89f948 0591-3524 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL TRANSDERMAL 20171012 ANDA ANDA091073 Actavis Pharma, Inc. TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0591-3525_79bb30ba-8dc9-4bb8-8e21-c9527bde0ede 0591-3525 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine PATCH TOPICAL 20130915 ANDA ANDA200675 Actavis Pharma, Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0591-3540_eff580f8-0072-4fa5-9ba3-145da6bf8122 0591-3540 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090324 ANDA ANDA079095 Actavis Pharma, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0591-3541_eff580f8-0072-4fa5-9ba3-145da6bf8122 0591-3541 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090324 ANDA ANDA079095 Actavis Pharma, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0591-3542_eff580f8-0072-4fa5-9ba3-145da6bf8122 0591-3542 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090324 ANDA ANDA079095 Actavis Pharma, Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0591-3543_5ef6f50e-1098-45b2-b099-ebafce9b73b3 0591-3543 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090611 ANDA ANDA079094 Actavis Pharma, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0591-3546_1cc04a68-82a1-4926-95c2-ba719c503c1f 0591-3546 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE ORAL 20061026 NDA AUTHORIZED GENERIC NDA019429 Actavis Pharma, Inc. CODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ASPIRIN 30; 50; 40; 325 mg/1; mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE] CIII N 20181231 0591-3551_ac57e32d-d9fb-444b-892c-8698db732de7 0591-3551 HUMAN PRESCRIPTION DRUG Oxycodone and Aspirin Oxycodone and Aspirin TABLET ORAL 20111018 ANDA ANDA090084 Actavis Pharma, Inc. OXYCODONE HYDROCHLORIDE; ASPIRIN 4.8355; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE] CII N 20181231 0591-3562_cd20b1d6-481b-4840-b36b-9933555d8e4b 0591-3562 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA078759 Watson Laboratories, Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0591-3563_cd20b1d6-481b-4840-b36b-9933555d8e4b 0591-3563 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA078759 Watson Laboratories, Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0591-3571_f04c0c97-bfc3-475b-bf37-ff637578ed90 0591-3571 HUMAN PRESCRIPTION DRUG Fentanyl Buccal Fentanyl Citrate TABLET BUCCAL; ORAL; TRANSMUCOSAL 20130101 ANDA ANDA079075 Actavis Pharma, Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3572_f04c0c97-bfc3-475b-bf37-ff637578ed90 0591-3572 HUMAN PRESCRIPTION DRUG Fentanyl Buccal Fentanyl Citrate TABLET BUCCAL; ORAL; TRANSMUCOSAL 20130101 ANDA ANDA079075 Actavis Pharma, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3573_f04c0c97-bfc3-475b-bf37-ff637578ed90 0591-3573 HUMAN PRESCRIPTION DRUG Fentanyl Buccal Fentanyl Citrate TABLET BUCCAL; ORAL; TRANSMUCOSAL 20130101 ANDA ANDA079075 Actavis Pharma, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3574_f04c0c97-bfc3-475b-bf37-ff637578ed90 0591-3574 HUMAN PRESCRIPTION DRUG Fentanyl Buccal Fentanyl Citrate TABLET BUCCAL; ORAL; TRANSMUCOSAL 20130101 ANDA ANDA079075 Actavis Pharma, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3575_f04c0c97-bfc3-475b-bf37-ff637578ed90 0591-3575 HUMAN PRESCRIPTION DRUG Fentanyl Buccal Fentanyl Citrate TABLET BUCCAL; ORAL; TRANSMUCOSAL 20130101 ANDA ANDA079075 Actavis Pharma, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3576_6e1cb452-4764-4040-b6f0-b312ff686f39 0591-3576 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Watson Laboratories, Inc. MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3591_cb54738f-c43b-07ed-1bfd-9e64fdc726e8 0591-3591 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 19940811 NDA NDA018651 Actavis Pharma, Inc. DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 0591-3592_cb54738f-c43b-07ed-1bfd-9e64fdc726e8 0591-3592 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20050607 NDA NDA018651 Actavis Pharma, Inc. DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 0591-3593_cb54738f-c43b-07ed-1bfd-9e64fdc726e8 0591-3593 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 19940811 NDA NDA018651 Actavis Pharma, Inc. DRONABINOL 10 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 0591-3600_301f2266-e379-437b-83d1-a7de0f903b0f 0591-3600 HUMAN PRESCRIPTION DRUG Fentanyl - NOVAPLUS Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Actavis Pharma, Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3601_301f2266-e379-437b-83d1-a7de0f903b0f 0591-3601 HUMAN PRESCRIPTION DRUG Fentanyl - NOVAPLUS Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Actavis Pharma, Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3602_301f2266-e379-437b-83d1-a7de0f903b0f 0591-3602 HUMAN PRESCRIPTION DRUG Fentanyl - NOVAPLUS Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Actavis Pharma, Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3603_301f2266-e379-437b-83d1-a7de0f903b0f 0591-3603 HUMAN PRESCRIPTION DRUG Fentanyl - NOVAPLUS Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20070901 ANDA ANDA076709 Actavis Pharma, Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3629_894e3b49-085a-4880-8753-5e39a23853b7 0591-3629 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140521 ANDA ANDA202144 Actavis Pharma, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 0591-3630_894e3b49-085a-4880-8753-5e39a23853b7 0591-3630 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140521 ANDA ANDA202144 Actavis Pharma, Inc. HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 0591-3631_e1794878-9ed7-4c2d-99db-3d7bd084f48d 0591-3631 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20161010 ANDA ANDA202144 Actavis Pharma, Inc. HYDROMORPHONE HYDROCHLORIDE 32 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0591-3635_1a76b3ce-6d76-4672-b9ec-a928969ca4e3 0591-3635 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091093 Actavis Pharma, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 0591-3636_506bc96c-bc6c-47aa-b410-9e331dad1e11 0591-3636 HUMAN PRESCRIPTION DRUG Trospium Chloride Trospium Chloride CAPSULE, EXTENDED RELEASE ORAL 20121012 ANDA ANDA091289 Actavis Pharma, Inc. TROSPIUM CHLORIDE 60 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0591-3658_b7105a36-f0b0-46e6-a638-555903e3bfd1 0591-3658 HUMAN PRESCRIPTION DRUG Nitrofurantoin monohydrate macrocrystals Nitrofurantoin monohydrate macrocrystals CAPSULE ORAL 20151113 ANDA ANDA202250 Actavis Pharma, Inc. NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0591-3659_423973f5-97cc-40a3-a099-853cdb3a9b70 0591-3659 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204065 Actavis Pharma, Inc. DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0591-3660_423973f5-97cc-40a3-a099-853cdb3a9b70 0591-3660 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204065 Actavis Pharma, Inc. DESVENLAFAXINE SUCCINATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0591-3670_08a4264e-5a71-4aa1-9533-6e28aae6a1ca 0591-3670 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 Actavis Pharma, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0591-3671_08a4264e-5a71-4aa1-9533-6e28aae6a1ca 0591-3671 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 Actavis Pharma, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0591-3684_262e04c9-590f-4f68-8d59-52d65506fef6 0591-3684 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin CAPSULE ORAL 20151001 ANDA ANDA091095 Actavis Pharma, Inc. NITROFURANTOIN 25 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0591-3685_262e04c9-590f-4f68-8d59-52d65506fef6 0591-3685 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin CAPSULE ORAL 20151001 ANDA ANDA091095 Actavis Pharma, Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0591-3686_262e04c9-590f-4f68-8d59-52d65506fef6 0591-3686 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin CAPSULE ORAL 20151001 ANDA ANDA091095 Actavis Pharma, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0591-3692_19b45011-1911-4a24-be57-783b91e365b3 0591-3692 HUMAN PRESCRIPTION DRUG Paliperidone Paliperidone TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150923 ANDA ANDA202645 Actavis Pharma, Inc. PALIPERIDONE 1.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0591-3693_19b45011-1911-4a24-be57-783b91e365b3 0591-3693 HUMAN PRESCRIPTION DRUG Paliperidone Paliperidone TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150923 ANDA ANDA202645 Actavis Pharma, Inc. PALIPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 0591-3694_19b45011-1911-4a24-be57-783b91e365b3 0591-3694 HUMAN PRESCRIPTION DRUG Paliperidone Paliperidone TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150923 ANDA ANDA202645 Actavis Pharma, Inc. PALIPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] N 20181231 0591-3695_19b45011-1911-4a24-be57-783b91e365b3 0591-3695 HUMAN PRESCRIPTION DRUG Paliperidone Paliperidone TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150923 ANDA ANDA202645 Actavis Pharma, Inc. PALIPERIDONE 9 mg/1 Atypical Antipsychotic [EPC] N 20181231 0591-3699_1a76b3ce-6d76-4672-b9ec-a928969ca4e3 0591-3699 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091093 Actavis Pharma, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 0591-3703_a9aa7b52-0cc6-4330-9b91-b723c95eec24 0591-3703 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20120828 ANDA ANDA200156 Watson Laboratories, Inc. ARMODAFINIL 100 mg/1 CIV E 20171231 0591-3704_a9aa7b52-0cc6-4330-9b91-b723c95eec24 0591-3704 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20120828 ANDA ANDA200156 Watson Laboratories, Inc. ARMODAFINIL 200 mg/1 CIV E 20171231 0591-3713_8e147856-b3b4-44e9-bbf4-43d67f86e42c 0591-3713 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20170612 ANDA ANDA200831 Actavis Pharma, Inc. EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 0591-3720_5fa1143e-0104-44eb-ada5-0aaa809c3d9d 0591-3720 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid TABLET, FILM COATED ORAL 20130103 ANDA ANDA202093 Actavis Pharma, Inc. TRANEXAMIC ACID 650 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 0591-3739_894e3b49-085a-4880-8753-5e39a23853b7 0591-3739 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140521 ANDA ANDA202144 Actavis Pharma, Inc. HYDROMORPHONE HYDROCHLORIDE 12 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 0591-3740_9611cc53-15f8-4dd7-af24-7f6990d183cd 0591-3740 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 Watson Laboratories, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0591-3741_9611cc53-15f8-4dd7-af24-7f6990d183cd 0591-3741 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 Watson Laboratories, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0591-3742_9611cc53-15f8-4dd7-af24-7f6990d183cd 0591-3742 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 Watson Laboratories, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0591-3743_9611cc53-15f8-4dd7-af24-7f6990d183cd 0591-3743 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074769 Watson Laboratories, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0591-3744_9611cc53-15f8-4dd7-af24-7f6990d183cd 0591-3744 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074769 Watson Laboratories, Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0591-3745_958cd302-2043-4362-ad37-4e0b41fd7bf1 0591-3745 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110222 ANDA ANDA091129 Actavis Pharma, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0591-3746_958cd302-2043-4362-ad37-4e0b41fd7bf1 0591-3746 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110222 ANDA ANDA091129 Actavis Pharma, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0591-3747_958cd302-2043-4362-ad37-4e0b41fd7bf1 0591-3747 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110222 ANDA ANDA091129 Actavis Pharma, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0591-3748_9353db75-51d5-444d-977d-de910fd6d72d 0591-3748 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20110112 ANDA ANDA200180 Watson Laboratories, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 0591-3749_9353db75-51d5-444d-977d-de910fd6d72d 0591-3749 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20110112 ANDA ANDA200180 Watson Laboratories, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 0591-3750_9353db75-51d5-444d-977d-de910fd6d72d 0591-3750 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20110112 ANDA ANDA200180 Watson Laboratories, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 0591-3757_7204079b-b212-4f9e-a6d7-a9c7ab7d37f2 0591-3757 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20101015 ANDA ANDA077890 Actavis Pharma, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0591-3758_7204079b-b212-4f9e-a6d7-a9c7ab7d37f2 0591-3758 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20101015 ANDA ANDA077890 Actavis Pharma, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0591-3759_7204079b-b212-4f9e-a6d7-a9c7ab7d37f2 0591-3759 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20101015 ANDA ANDA077890 Actavis Pharma, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0591-3760_7204079b-b212-4f9e-a6d7-a9c7ab7d37f2 0591-3760 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20101015 ANDA ANDA077890 Actavis Pharma, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0591-3761_47c2bcaf-aebf-4af0-b929-4b00807f7a5d 0591-3761 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090364 Actavis Pharma, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0591-3762_47c2bcaf-aebf-4af0-b929-4b00807f7a5d 0591-3762 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090364 Actavis Pharma, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0591-3767_1e0fe902-6fdb-4464-be47-607ff9551734 0591-3767 HUMAN PRESCRIPTION DRUG Budesonide Inhalation Budesonide SUSPENSION RESPIRATORY (INHALATION) 20151217 20180531 ANDA ANDA078404 Actavis Pharma, Inc. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0591-3768_1e0fe902-6fdb-4464-be47-607ff9551734 0591-3768 HUMAN PRESCRIPTION DRUG Budesonide Inhalation Budesonide SUSPENSION RESPIRATORY (INHALATION) 20150217 20180531 ANDA ANDA078404 Actavis Pharma, Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0591-3770_611c339c-262f-4801-9222-ee4498304303 0591-3770 HUMAN PRESCRIPTION DRUG Ibandronate Sodium ibandronate sodium TABLET ORAL 20120320 ANDA ANDA079003 Actavis Pharma, Inc. IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0591-3771_bdad5408-8b8a-493e-93ec-62adea4f2606 0591-3771 HUMAN PRESCRIPTION DRUG Dutasteride and tamsulosin hydrochloride Dutasteride and tamsulosin hydrochloride CAPSULE ORAL 20160413 ANDA ANDA202975 Actavis Pharma, Inc. DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE .5; .4 mg/1; mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA],Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0591-3774_ea563d25-0c19-4285-bb0c-095c8e461aae 0591-3774 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Watson Laboratories, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0591-3775_ea563d25-0c19-4285-bb0c-095c8e461aae 0591-3775 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Watson Laboratories, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0591-3776_ea563d25-0c19-4285-bb0c-095c8e461aae 0591-3776 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Watson Laboratories, Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0591-3777_ea563d25-0c19-4285-bb0c-095c8e461aae 0591-3777 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Watson Laboratories, Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0591-3780_83707c92-9b0c-4cc1-ba44-f932656d174d 0591-3780 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil Citrate TABLET, FILM COATED ORAL 20121119 20180228 ANDA ANDA202503 Actavis Pharma, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 0591-3797_7292f617-ec77-4ff8-b680-fc9419e2ec2f 0591-3797 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20101104 ANDA ANDA077839 Actavis Pharma, Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0591-3798_80ba0b16-1597-4dbb-9cbe-4b35c1e43c84 0591-3798 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110301 ANDA ANDA075693 Actavis Pharma, Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0591-3817_9da55243-75d7-4e8b-83a3-434f7b71d2be 0591-3817 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate ipratropium bromide and albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20130513 ANDA ANDA202496 Actavis Pharma, Inc. IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 2.5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0591-3856_cfa0ae8e-1c94-42e8-a19c-7278cc5cf634 0591-3856 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20160601 NDA AUTHORIZED GENERIC NDA021875 Actavis Pharma, Inc. ARMODAFINIL 200 mg/1 CIV N 20181231 0591-3870_8bfb83c3-e896-456f-a95d-a56e97d5e906 0591-3870 HUMAN PRESCRIPTION DRUG memantine hydrochloride memantine hydrochloride TABLET ORAL 20150401 NDA NDA021487 Actavis Pharma, Inc MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 0591-3875_8bfb83c3-e896-456f-a95d-a56e97d5e906 0591-3875 HUMAN PRESCRIPTION DRUG memantine hydrochloride memantine hydrochloride TABLET ORAL 20150401 NDA NDA021487 Actavis Pharma, Inc MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 0591-3876_aa3e091a-7bfe-4e74-9aa1-0cbfa9ab7e23 0591-3876 HUMAN PRESCRIPTION DRUG Risedronate Sodium risedronate sodium TABLET, DELAYED RELEASE ORAL 20101201 NDA NDA022560 Actavis Pharma, Inc. RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE 30.1; 4.9 mg/1; mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0591-3892_d9e0c2a0-22fc-46d6-873d-808d54213613 0591-3892 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20161205 ANDA ANDA070848 Actavis Pharma, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 0591-3900_8bfb83c3-e896-456f-a95d-a56e97d5e906 0591-3900 HUMAN PRESCRIPTION DRUG memantine hydrochloride memantine hydrochloride KIT ORAL 20150401 NDA NDA021487 Actavis Pharma, Inc N 20191231 0591-3964_eec80006-e7f9-db9d-e69f-7a266a573e61 0591-3964 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20100730 20180430 NDA NDA019781 Actavis Pharma, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 0591-3965_eec80006-e7f9-db9d-e69f-7a266a573e61 0591-3965 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20100730 20180831 NDA NDA019781 Actavis Pharma, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 0591-3982_ff264066-dad7-47ff-98bd-74f26bc983fb 0591-3982 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150312 ANDA ANDA200562 Actavis Pharma, Inc. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0591-3983_ff264066-dad7-47ff-98bd-74f26bc983fb 0591-3983 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150312 ANDA ANDA200562 Actavis Pharma, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0591-3984_ff264066-dad7-47ff-98bd-74f26bc983fb 0591-3984 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150312 ANDA ANDA200562 Actavis Pharma, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0591-3985_ff264066-dad7-47ff-98bd-74f26bc983fb 0591-3985 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150312 ANDA ANDA200562 Actavis Pharma, Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0591-4012_bc826123-d958-41d8-b19a-00c36f782e6a 0591-4012 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 20090908 ANDA ANDA073229 Actavis Pharma, Inc. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0591-4039_caebba55-a8f2-41c5-a3ce-ab94cdccdc5f 0591-4039 HUMAN PRESCRIPTION DRUG CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SPRAY TOPICAL 20150828 NDA AUTHORIZED GENERIC NDA021835 Actavis Pharma, Inc. CLOBETASOL PROPIONATE .05 g/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0591-4060_423973f5-97cc-40a3-a099-853cdb3a9b70 0591-4060 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204065 Actavis Pharma, Inc. DESVENLAFAXINE SUCCINATE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0591-4101_c30c8f89-6b6c-40a5-897e-785f760ff59b 0591-4101 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20170530 ANDA ANDA207582 Actavis Pharma, Inc. PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0591-4102_c30c8f89-6b6c-40a5-897e-785f760ff59b 0591-4102 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20170530 ANDA ANDA207582 Actavis Pharma, Inc. PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0591-4103_c30c8f89-6b6c-40a5-897e-785f760ff59b 0591-4103 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20170530 ANDA ANDA207582 Actavis Pharma, Inc. PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0591-4104_c30c8f89-6b6c-40a5-897e-785f760ff59b 0591-4104 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20170530 ANDA ANDA207582 Actavis Pharma, Inc. PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0591-4128_c1571ed2-8fc6-4f5f-ba48-bbb76ea75dfc 0591-4128 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION INTRAMUSCULAR 20150305 ANDA ANDA091244 Actavis Pharma, Inc. TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0591-4130_e681ee9e-e794-45e9-8033-5fc913efbb2a 0591-4130 HUMAN PRESCRIPTION DRUG Levoleucovorin Levoleucovorin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170206 NDA NDA208723 Actavis Pharma, Inc. LEVOLEUCOVORIN CALCIUM 10 mg/mL N 20181231 0591-4375_ed88ca2a-2d88-497f-99d4-2c48bfa0ebba 0591-4375 HUMAN PRESCRIPTION DRUG Darifenacin darifenacin TABLET, EXTENDED RELEASE ORAL 20160315 NDA NDA021513 Actavis Pharma, Inc. DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0591-4380_ed88ca2a-2d88-497f-99d4-2c48bfa0ebba 0591-4380 HUMAN PRESCRIPTION DRUG Darifenacin darifenacin TABLET, EXTENDED RELEASE ORAL 20160315 NDA NDA021513 Actavis Pharma, Inc. DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0591-4920_5c88d7b4-7709-462a-b647-f01e29567d39 0591-4920 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride TABLET ORAL 20170103 ANDA ANDA208096 Actavis Pharma, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 0591-4930_90959e9e-2da9-4cfc-8ad8-6cb3f58bdc37 0591-4930 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 20170125 ANDA ANDA208107 Actavis Pharma, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 0591-5052_f73c7473-037d-421a-826c-42faba54bb81 0591-5052 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19900101 ANDA ANDA080356 Actavis Pharma, Inc. PREDNISONE 5 mg/1 N 20181231 0591-5215_d5faaf0d-ebf2-4a27-84a6-fe3719bfdef6 0591-5215 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20141124 ANDA ANDA070044 Actavis Pharma, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20191231 0591-5238_cdc0fb08-c4ae-4e0b-bf7b-087cd8dfbe43 0591-5238 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 19730503 ANDA ANDA083308 Actavis Pharma, Inc. MEPROBAMATE 400 mg/1 CIV N 20181231 0591-5239_cdc0fb08-c4ae-4e0b-bf7b-087cd8dfbe43 0591-5239 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 19730423 ANDA ANDA083304 Actavis Pharma, Inc. MEPROBAMATE 200 mg/1 CIV N 20181231 0591-5307_8456fa5f-5ff8-49a6-8cb9-7fe4169e09b1 0591-5307 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 Actavis Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0591-5319_8456fa5f-5ff8-49a6-8cb9-7fe4169e09b1 0591-5319 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730921 ANDA ANDA083711 Actavis Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0591-5321_3f9acf99-162b-4c97-b494-c37038523dc0 0591-5321 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20100619 ANDA ANDA083551 Actavis Pharma, Inc. PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0591-5325_280fb835-a785-4735-b010-741d74a6793e 0591-5325 HUMAN PRESCRIPTION DRUG Probenecid and Colchicine Probenecid and Colchicine TABLET ORAL 19821001 ANDA ANDA084279 Actavis Pharma, Inc. PROBENECID; COLCHICINE 500; .5 mg/1; mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20181231 0591-5335_cbcbdba5-82b1-4adf-9c5c-63033c3524b0 0591-5335 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 19871101 ANDA ANDA084363 Actavis Pharma, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 0591-5337_cbcbdba5-82b1-4adf-9c5c-63033c3524b0 0591-5337 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 19871101 ANDA ANDA084364 Actavis Pharma, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 N 20181231 0591-5347_0e69d46c-0752-4c73-963a-c6caf9a7dd37 0591-5347 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 19830701 ANDA ANDA084442 Actavis Pharma, Inc. PROBENECID 500 mg/1 N 20181231 0591-5381_1d17af0a-b48a-4f73-a1a6-98581d817e9a 0591-5381 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19871101 ANDA ANDA084277 Actavis Pharma, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0591-5382_1d17af0a-b48a-4f73-a1a6-98581d817e9a 0591-5382 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19871101 ANDA ANDA084276 Actavis Pharma, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0591-5438_89d03d0f-7d8c-4f38-a310-9a9739a03397 0591-5438 HUMAN PRESCRIPTION DRUG Quinidine Sulfate Quinidine Sulfate TABLET ORAL 19761124 ANDA ANDA083288 Watson Laboratories, Inc. QUINIDINE SULFATE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0591-5440_930598d9-ea11-4a50-9c08-8d9eda83559e 0591-5440 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19900101 ANDA ANDA062031 Actavis Pharma, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0591-5442_f73c7473-037d-421a-826c-42faba54bb81 0591-5442 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19900101 ANDA ANDA085162 Actavis Pharma, Inc. PREDNISONE 10 mg/1 N 20181231 0591-5443_f73c7473-037d-421a-826c-42faba54bb81 0591-5443 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19900101 ANDA ANDA085161 Actavis Pharma, Inc. PREDNISONE 20 mg/1 N 20181231 0591-5454_89d03d0f-7d8c-4f38-a310-9a9739a03397 0591-5454 HUMAN PRESCRIPTION DRUG Quinidine Sulfate Quinidine Sulfate TABLET ORAL 19810609 ANDA ANDA085583 Watson Laboratories, Inc. QUINIDINE SULFATE 300 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0591-5513_267605a9-95b8-4eb6-9aec-db9f690dd523 0591-5513 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19871101 ANDA ANDA087499 Actavis Pharma, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 0591-5535_930598d9-ea11-4a50-9c08-8d9eda83559e 0591-5535 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19900101 ANDA ANDA062031 Actavis Pharma, Inc. DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 0591-5543_cd502087-26ea-45d3-8923-847f032ea5e4 0591-5543 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018832 Actavis Pharma, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0591-5544_cd502087-26ea-45d3-8923-847f032ea5e4 0591-5544 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018877 Actavis Pharma, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0591-5553_930598d9-ea11-4a50-9c08-8d9eda83559e 0591-5553 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19900101 ANDA ANDA062421 Actavis Pharma, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0591-5554_d7059e2a-de27-4d12-becd-8dc8f6b12fc8 0591-5554 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070175 Actavis Pharma, Inc. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0591-5555_d7059e2a-de27-4d12-becd-8dc8f6b12fc8 0591-5555 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070176 Actavis Pharma, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0591-5556_d7059e2a-de27-4d12-becd-8dc8f6b12fc8 0591-5556 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070177 Actavis Pharma, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0591-5557_d7059e2a-de27-4d12-becd-8dc8f6b12fc8 0591-5557 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070178 Actavis Pharma, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0591-5560_83302efb-279c-4a7e-bc97-69c640dce449 0591-5560 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 19850531 ANDA ANDA070173 Actavis Pharma, Inc. DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 0591-5561_83302efb-279c-4a7e-bc97-69c640dce449 0591-5561 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 19850531 ANDA ANDA070174 Actavis Pharma, Inc. DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 0591-5571_0510dff2-f392-4fb0-a6c6-f07f6d7716a7 0591-5571 HUMAN PRESCRIPTION DRUG Trimethoprim Trimethoprim TABLET ORAL 20100404 ANDA ANDA070049 Actavis Pharma, Inc. TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0591-5590_2ef7f5de-ac6c-4a75-a81a-fef08ff757b1 0591-5590 HUMAN PRESCRIPTION DRUG Tranylcypromine Sulfate tranylcypromine sulfate TABLET, FILM COATED ORAL 20160205 NDA AUTHORIZED GENERIC NDA012342 Actavis Pharma, Inc. TRANYLCYPROMINE SULFATE 10 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20191231 0591-5619_bfdcdb4e-a264-46c1-822e-a925696a1125 0591-5619 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071135 Actavis Pharma, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0591-5620_bfdcdb4e-a264-46c1-822e-a925696a1125 0591-5620 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071136 Actavis Pharma, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0591-5621_bfdcdb4e-a264-46c1-822e-a925696a1125 0591-5621 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071134 Actavis Pharma, Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0591-5642_fb04425b-d72a-42a6-aae1-60c111f26b49 0591-5642 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20091026 ANDA ANDA071344 Actavis Pharma, Inc. MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 0591-5643_fb04425b-d72a-42a6-aae1-60c111f26b49 0591-5643 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20091026 ANDA ANDA071345 Actavis Pharma, Inc. MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 0591-5658_2676e20d-0030-42ec-8d88-79c3c40fe9ba 0591-5658 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19890503 ANDA ANDA071611 Actavis Pharma, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0591-5660_258c3677-db23-4355-88e9-fb468b573c98 0591-5660 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071795 Actavis Pharma, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0591-5661_258c3677-db23-4355-88e9-fb468b573c98 0591-5661 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071891 Actavis Pharma, Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0591-5694_54e21205-366f-47ac-a758-7d6dcd07782c 0591-5694 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19920201 ANDA ANDA063181 Actavis Pharma, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0591-5695_54e21205-366f-47ac-a758-7d6dcd07782c 0591-5695 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA063065 Actavis Pharma, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0591-5708_f3c03f1c-fc3a-4d67-a0f0-791918955623 0591-5708 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19900101 ANDA ANDA063083 Actavis Pharma, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0591-5713_ecac4131-425f-405f-834f-3744410d316c 0591-5713 HUMAN PRESCRIPTION DRUG Amoxapine Amoxapine TABLET ORAL 19920828 ANDA ANDA072688 Actavis Pharma, Inc. AMOXAPINE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0591-5714_ecac4131-425f-405f-834f-3744410d316c 0591-5714 HUMAN PRESCRIPTION DRUG Amoxapine Amoxapine TABLET ORAL 19920828 ANDA ANDA072689 Actavis Pharma, Inc. AMOXAPINE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0591-5715_ecac4131-425f-405f-834f-3744410d316c 0591-5715 HUMAN PRESCRIPTION DRUG Amoxapine Amoxapine TABLET ORAL 19920828 ANDA ANDA072690 Actavis Pharma, Inc. AMOXAPINE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0591-5716_ecac4131-425f-405f-834f-3744410d316c 0591-5716 HUMAN PRESCRIPTION DRUG Amoxapine Amoxapine TABLET ORAL 19920828 ANDA ANDA072691 Actavis Pharma, Inc. AMOXAPINE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0591-5782_41bf9ab0-859a-4b0f-911b-e9b55c60ac49 0591-5782 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Actavis Pharma, Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0591-5783_41bf9ab0-859a-4b0f-911b-e9b55c60ac49 0591-5783 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Actavis Pharma, Inc. ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0591-5786_2a021427-d29d-4d2e-b9a1-6ef32ffc1c55 0591-5786 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073553 Watson Laboratories, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0591-5787_2a021427-d29d-4d2e-b9a1-6ef32ffc1c55 0591-5787 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073554 Watson Laboratories, Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0591-5788_2a021427-d29d-4d2e-b9a1-6ef32ffc1c55 0591-5788 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073555 Watson Laboratories, Inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0591-5789_2a021427-d29d-4d2e-b9a1-6ef32ffc1c55 0591-5789 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073556 Watson Laboratories, Inc. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0591-5882_965dc04a-016a-4893-bac4-7b4035dfa3f9 0591-5882 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 19900101 ANDA ANDA040220 Actavis Pharma, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0591-5883_965dc04a-016a-4893-bac4-7b4035dfa3f9 0591-5883 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 19900101 ANDA ANDA040220 Actavis Pharma, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0591-5884_965dc04a-016a-4893-bac4-7b4035dfa3f9 0591-5884 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 19900101 ANDA ANDA040220 Actavis Pharma, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0591-6100_24c3a9cf-d2b4-4247-8517-ddb33fba3bf9 0591-6100 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20170619 NDA NDA205931 Actavis Pharma, Inc. DOXYCYCLINE HYCLATE 75 mg/1 N 20181231 0591-6125_24c3a9cf-d2b4-4247-8517-ddb33fba3bf9 0591-6125 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20170619 NDA NDA205931 Actavis Pharma, Inc. DOXYCYCLINE HYCLATE 150 mg/1 N 20181231 0597-0001_f0a7d9c9-c119-aae0-ae19-4e96ffadff01 0597-0001 HUMAN PRESCRIPTION DRUG Aggrenox aspirin and dipyridamole CAPSULE, EXTENDED RELEASE ORAL 19991219 NDA NDA020884 Boehringer Ingelheim Pharmaceuticals, Inc. ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0597-0002_6d6ce478-4464-9f6c-8933-8da6daee05fe 0597-0002 HUMAN PRESCRIPTION DRUG Aptivus tipranavir SOLUTION ORAL 20080901 NDA NDA022292 Boehringer Ingelheim Pharmaceuticals, Inc. TIPRANAVIR 100 mg/mL HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] N 20181231 0597-0003_6d6ce478-4464-9f6c-8933-8da6daee05fe 0597-0003 HUMAN PRESCRIPTION DRUG Aptivus tipranavir CAPSULE, LIQUID FILLED ORAL 20050701 NDA NDA021814 Boehringer Ingelheim Pharmaceuticals, Inc. TIPRANAVIR 250 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC] N 20181231 0597-0006_3c3a0d4a-3a9c-ae92-f28a-aa1714ffeb0f 0597-0006 HUMAN PRESCRIPTION DRUG Catapres clonidine hydrochloride TABLET ORAL 19990501 NDA NDA017407 Boehringer Ingelheim Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0597-0007_3c3a0d4a-3a9c-ae92-f28a-aa1714ffeb0f 0597-0007 HUMAN PRESCRIPTION DRUG Catapres clonidine hydrochloride TABLET ORAL 19990501 NDA NDA017407 Boehringer Ingelheim Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0597-0011_3c3a0d4a-3a9c-ae92-f28a-aa1714ffeb0f 0597-0011 HUMAN PRESCRIPTION DRUG Catapres clonidine hydrochloride TABLET ORAL 19990501 NDA NDA017407 Boehringer Ingelheim Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0597-0012_c19de20b-31cd-d123-f954-199e1499b941 0597-0012 HUMAN OTC DRUG Dulcolax bisacodyl TABLET, COATED ORAL 20011001 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals, Inc. BISACODYL 5 mg/1 N 20181231 0597-0016_ac8d5286-b70b-d2b0-3526-79e42a106581 0597-0016 HUMAN OTC DRUG Dulcolax Docusate sodium CAPSULE, LIQUID FILLED ORAL 20021001 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 0597-0017_64df3878-9783-4fe3-86c0-ae13b29af8ab 0597-0017 HUMAN PRESCRIPTION DRUG Persantine dipyridamole TABLET, COATED ORAL 19990601 NDA NDA012836 Boehringer Ingelheim Pharmaceuticals, Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0597-0018_64df3878-9783-4fe3-86c0-ae13b29af8ab 0597-0018 HUMAN PRESCRIPTION DRUG Persantine dipyridamole TABLET, COATED ORAL 19990601 NDA NDA012836 Boehringer Ingelheim Pharmaceuticals, Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0597-0019_64df3878-9783-4fe3-86c0-ae13b29af8ab 0597-0019 HUMAN PRESCRIPTION DRUG Persantine dipyridamole TABLET, COATED ORAL 19990601 NDA NDA012836 Boehringer Ingelheim Pharmaceuticals, Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0597-0024_7ee08565-596d-951a-c695-831c58545f09 0597-0024 HUMAN PRESCRIPTION DRUG Combivent Respimat ipratropium bromide and albuterol SPRAY, METERED RESPIRATORY (INHALATION) 20120701 NDA NDA021747 Boehringer Ingelheim Pharmaceuticals Inc. IPRATROPIUM BROMIDE; ALBUTEROL SULFATE 20; 120 ug/1; ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0597-0029_87081d5a-ac6a-dab7-2c9e-aed1a56776cf 0597-0029 HUMAN PRESCRIPTION DRUG Mobic meloxicam TABLET ORAL 20010625 NDA NDA020938 Boehringer Ingelheim Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 0597-0030_87081d5a-ac6a-dab7-2c9e-aed1a56776cf 0597-0030 HUMAN PRESCRIPTION DRUG Mobic meloxicam TABLET ORAL 20001001 NDA NDA020938 Boehringer Ingelheim Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 0597-0031_5b22f8cb-2f48-4f70-b996-f9ab65e758c4 0597-0031 HUMAN PRESCRIPTION DRUG Catapres clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 19851001 NDA NDA018891 Boehringer Ingelheim Pharmaceuticals Inc. CLONIDINE .1 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0597-0032_5b22f8cb-2f48-4f70-b996-f9ab65e758c4 0597-0032 HUMAN PRESCRIPTION DRUG Catapres clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 19851001 NDA NDA018891 Boehringer Ingelheim Pharmaceuticals Inc. CLONIDINE .2 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0597-0033_5b22f8cb-2f48-4f70-b996-f9ab65e758c4 0597-0033 HUMAN PRESCRIPTION DRUG Catapres clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 19851001 NDA NDA018891 Boehringer Ingelheim Pharmaceuticals Inc. CLONIDINE .3 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0597-0034_9dfac843-a839-01ee-a80c-6face28bccc6 0597-0034 HUMAN PRESCRIPTION DRUG Mobic meloxicam SUSPENSION ORAL 20051101 NDA NDA021530 Boehringer Ingelheim Pharmaceuticals, Inc. MELOXICAM 7.5 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0597-0039_62800d44-ab86-4d73-ca98-900b5c060848 0597-0039 HUMAN PRESCRIPTION DRUG Micardis telmisartan TABLET ORAL 20001201 NDA NDA020850 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0597-0040_62800d44-ab86-4d73-ca98-900b5c060848 0597-0040 HUMAN PRESCRIPTION DRUG Micardis telmisartan TABLET ORAL 20001201 NDA NDA020850 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0597-0041_62800d44-ab86-4d73-ca98-900b5c060848 0597-0041 HUMAN PRESCRIPTION DRUG Micardis telmisartan TABLET ORAL 20001201 NDA NDA020850 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0597-0042_65efa704-8f9c-4086-5c36-a8e1ad0bb9ec 0597-0042 HUMAN PRESCRIPTION DRUG Micardis HCT telmisartan and hydrochlorothiazide TABLET ORAL 20001201 NDA NDA021162 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0597-0043_65efa704-8f9c-4086-5c36-a8e1ad0bb9ec 0597-0043 HUMAN PRESCRIPTION DRUG Micardis HCT telmisartan and hydrochlorothiazide TABLET ORAL 20001201 NDA NDA021162 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0597-0044_65efa704-8f9c-4086-5c36-a8e1ad0bb9ec 0597-0044 HUMAN PRESCRIPTION DRUG Micardis HCT telmisartan and hydrochlorothiazide TABLET ORAL 20001201 NDA NDA021162 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0597-0046_554913e8-f01f-4bdb-ccb0-772852a7424b 0597-0046 HUMAN PRESCRIPTION DRUG Viramune nevirapine TABLET ORAL 20010801 NDA NDA020636 Boehringer Ingelheim Pharmaceuticals Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0597-0047_554913e8-f01f-4bdb-ccb0-772852a7424b 0597-0047 HUMAN PRESCRIPTION DRUG Viramune nevirapine SUSPENSION ORAL 20011001 NDA NDA020933 Boehringer Ingelheim Pharmaceuticals Inc. NEVIRAPINE 50 mg/5mL Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0597-0051_8c58de13-78c0-a5b4-eb63-3f5263cc2b56 0597-0051 HUMAN OTC DRUG Dulcolax Pink bisacodyl TABLET, COATED ORAL 20140701 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals Inc. BISACODYL 5 mg/1 N 20181231 0597-0052_82b92aa8-1b74-abcc-b5aa-c8d8a8cf5472 0597-0052 HUMAN OTC DRUG Dulcolax Bisacodyl SUPPOSITORY RECTAL 20020401 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals, Inc. BISACODYL 10 mg/1 N 20181231 0597-0053_ddb60ccd-e41c-4a52-a84d-f164073f3fec 0597-0053 HUMAN PRESCRIPTION DRUG GlucaGen glucagon hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050622 NDA NDA020918 Boehringer Ingelheim Pharmaceuticals, Inc. GLUCAGON HYDROCHLORIDE 1 mg/mL Antihypoglycemic Agent [EPC],Gastrointestinal Motility Inhibitor [EPC],Increased Gluconeogenesis [PE],Increased Glycogenolysis [PE],Decreased GI Smooth Muscle Tone [PE],Decreased GI Motility [PE],Decreased Glycolysis [PE] N 20181231 0597-0058_870e6747-469f-d4c7-89d9-8e2616d05681 0597-0058 HUMAN PRESCRIPTION DRUG Flomax tamsulosin hydrochloride CAPSULE ORAL 19970912 NDA NDA020579 Boehringer Ingelheim Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0597-0075_f04140bc-0901-9ca2-0cb7-3e774c8afca1 0597-0075 HUMAN PRESCRIPTION DRUG Spiriva TIOTROPIUM BROMIDE CAPSULE ORAL; RESPIRATORY (INHALATION) 20051011 NDA NDA021395 Boehringer Ingelheim Pharmaceuticals Inc. TIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0597-0081_325c9dc4-1c32-7586-a637-6cbe38d05914 0597-0081 HUMAN PRESCRIPTION DRUG Atrovent ipratropium bromide SPRAY, METERED NASAL 19960101 NDA NDA020393 Boehringer Ingelheim Pharmaceuticals, Inc. IPRATROPIUM BROMIDE 21 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0597-0086_ab0c4007-d975-e11c-61ab-ae129f6f0d90 0597-0086 HUMAN PRESCRIPTION DRUG Atrovent ipratropium bromide SPRAY, METERED NASAL 19960101 NDA NDA020394 Boehringer Ingelheim Pharmaceuticals, Inc. IPRATROPIUM BROMIDE 42 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0597-0087_c0d25051-33ec-3859-52e4-8d00f29411a0 0597-0087 HUMAN PRESCRIPTION DRUG Atrovent HFA ipratropium bromide AEROSOL, METERED RESPIRATORY (INHALATION) 20050501 NDA NDA021527 Boehringer Ingelheim Pharmaceuticals Inc. IPRATROPIUM BROMIDE 17 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0597-0100_7c99bf78-d9e2-1b8e-e5ec-d56593430923 0597-0100 HUMAN PRESCRIPTION DRUG Spiriva Respimat tiotropium bromide inhalation spray SPRAY, METERED RESPIRATORY (INHALATION) 20140930 NDA NDA021936 Boehringer Ingelheim Pharmaceuticals, Inc. TIOTROPIUM BROMIDE 3.124 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0597-0101_f045dd1f-c273-4427-6b3b-0c64011f30d1 0597-0101 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20071001 NDA NDA020667 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0108_cc1eb28e-8ad7-ba33-594a-8ca2cc1768f0 0597-0108 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20151123 NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 110 mg/1 N 20181231 0597-0109_b69ea7f6-1c60-801c-1e34-e61a9f28c559 0597-0109 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20100222 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .375 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0113_b69ea7f6-1c60-801c-1e34-e61a9f28c559 0597-0113 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20100222 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0115_b69ea7f6-1c60-801c-1e34-e61a9f28c559 0597-0115 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20100222 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0116_b69ea7f6-1c60-801c-1e34-e61a9f28c559 0597-0116 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20100222 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 4.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0120_c68afd90-d12b-cd99-812f-61482df5c24c 0597-0120 HUMAN OTC DRUG Zantac Maximum Strength 150 Cool Mint ranitidine TABLET, COATED ORAL 20061221 NDA NDA021698 Boehringer Ingelheim Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 0597-0121_75260c56-23f1-66dd-10ba-4728a73e5bf9 0597-0121 HUMAN OTC DRUG Maximum Strength Zantac ranitidine TABLET, COATED ORAL 20061221 NDA NDA021698 Boehringer Ingelheim Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 0597-0122_4bc42463-66dd-ea6e-379c-d319c60fa4dc 0597-0122 HUMAN OTC DRUG Zantac 75 ranitidine TABLET, COATED ORAL 20061221 NDA NDA020520 Boehringer Ingelheim Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 0597-0123_ac202b30-c476-6df3-5639-5d26165c4820 0597-0123 HUMAN PRESCRIPTION DRUG Viramune nevirapine TABLET, EXTENDED RELEASE ORAL 20110411 NDA NDA201152 Boehringer Ingelheim Pharmaceuticals, Inc. NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0597-0124_7c71ba01-79b3-2b3d-66e7-d12219ecc617 0597-0124 HUMAN PRESCRIPTION DRUG Twynsta telmisartan/amlodipine TABLET, MULTILAYER ORAL 20091102 NDA NDA022401 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN; AMLODIPINE BESYLATE 40; 5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0597-0125_7c71ba01-79b3-2b3d-66e7-d12219ecc617 0597-0125 HUMAN PRESCRIPTION DRUG Twynsta telmisartan/amlodipine TABLET, MULTILAYER ORAL 20091102 NDA NDA022401 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN; AMLODIPINE BESYLATE 40; 10 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0597-0126_7c71ba01-79b3-2b3d-66e7-d12219ecc617 0597-0126 HUMAN PRESCRIPTION DRUG Twynsta telmisartan/amlodipine TABLET, MULTILAYER ORAL 20091102 NDA NDA022401 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN; AMLODIPINE BESYLATE 80; 5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0597-0127_7c71ba01-79b3-2b3d-66e7-d12219ecc617 0597-0127 HUMAN PRESCRIPTION DRUG Twynsta telmisartan/amlodipine TABLET, MULTILAYER ORAL 20091102 NDA NDA022401 Boehringer Ingelheim Pharmaceuticals, Inc. TELMISARTAN; AMLODIPINE BESYLATE 80; 10 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0597-0129_ac202b30-c476-6df3-5639-5d26165c4820 0597-0129 HUMAN PRESCRIPTION DRUG Viramune nevirapine TABLET, EXTENDED RELEASE ORAL 20130301 NDA NDA201152 Boehringer Ingelheim Pharmaceuticals, Inc. NEVIRAPINE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0597-0135_cc1eb28e-8ad7-ba33-594a-8ca2cc1768f0 0597-0135 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20101026 NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 150 mg/1 N 20181231 0597-0137_548f8e65-34ea-674d-e748-dbc8f4aae0d4 0597-0137 HUMAN PRESCRIPTION DRUG Gilotrif afatinib TABLET, FILM COATED ORAL 20130712 NDA NDA201292 Boehringer Ingelheim Pharmaceuticals, Inc. AFATINIB 30 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0597-0138_548f8e65-34ea-674d-e748-dbc8f4aae0d4 0597-0138 HUMAN PRESCRIPTION DRUG Gilotrif afatinib TABLET, FILM COATED ORAL 20130712 NDA NDA201292 Boehringer Ingelheim Pharmaceuticals, Inc. AFATINIB 40 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0597-0140_1135e6c8-c2ae-d958-20ba-6c1eda889aa2 0597-0140 HUMAN PRESCRIPTION DRUG Tradjenta linagliptin TABLET, FILM COATED ORAL 20110509 NDA NDA201280 Boehringer Ingelheim Pharmaceuticals, Inc. LINAGLIPTIN 5 mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] N 20181231 0597-0141_548f8e65-34ea-674d-e748-dbc8f4aae0d4 0597-0141 HUMAN PRESCRIPTION DRUG Gilotrif afatinib TABLET, FILM COATED ORAL 20130712 NDA NDA201292 Boehringer Ingelheim Pharmaceuticals, Inc. AFATINIB 20 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0597-0143_9d3e6840-8fda-f171-00df-345f7d3ec38b 0597-0143 HUMAN PRESCRIPTION DRUG Ofev nintedanib CAPSULE ORAL 20141015 NDA NDA205832 Boehringer Ingelheim Pharmaceuticals, Inc. NINTEDANIB 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0597-0145_9d3e6840-8fda-f171-00df-345f7d3ec38b 0597-0145 HUMAN PRESCRIPTION DRUG Ofev nintedanib CAPSULE ORAL 20141015 NDA NDA205832 Boehringer Ingelheim Pharmaceuticals, Inc. NINTEDANIB 150 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 0597-0146_7cae1141-a2b5-f43a-8839-bf4642303c68 0597-0146 HUMAN PRESCRIPTION DRUG Jentadueto linagliptin and metformin hydrochloride TABLET, FILM COATED ORAL 20120213 NDA NDA201281 Boehringer Ingelheim Pharmaceuticals, Inc. LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] N 20181231 0597-0147_7cae1141-a2b5-f43a-8839-bf4642303c68 0597-0147 HUMAN PRESCRIPTION DRUG Jentadueto linagliptin and metformin hydrochloride TABLET, FILM COATED ORAL 20120213 NDA NDA201281 Boehringer Ingelheim Pharmaceuticals, Inc. LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5; 850 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0597-0148_7cae1141-a2b5-f43a-8839-bf4642303c68 0597-0148 HUMAN PRESCRIPTION DRUG Jentadueto linagliptin and metformin hydrochloride TABLET, FILM COATED ORAL 20120213 NDA NDA201281 Boehringer Ingelheim Pharmaceuticals, Inc. LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0597-0149_cc1eb28e-8ad7-ba33-594a-8ca2cc1768f0 0597-0149 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20110808 NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 75 mg/1 N 20181231 0597-0151_6a1d9279-c9b6-6c16-8842-05b95b85f773 0597-0151 HUMAN OTC DRUG DulcoEase Pink docusate sodium CAPSULE, LIQUID FILLED ORAL 20130201 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 0597-0152_2390b4d5-f72b-3356-27e3-c07d7daa9d4e 0597-0152 HUMAN PRESCRIPTION DRUG Jardiance Empagliflozin TABLET, FILM COATED ORAL 20140801 NDA NDA204629 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN 10 mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] N 20181231 0597-0153_2390b4d5-f72b-3356-27e3-c07d7daa9d4e 0597-0153 HUMAN PRESCRIPTION DRUG Jardiance Empagliflozin TABLET, FILM COATED ORAL 20140801 NDA NDA204629 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN 25 mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] N 20181231 0597-0155_a7181c67-0e79-017a-eaf1-960e233edfac 0597-0155 HUMAN PRESCRIPTION DRUG Stiolto Respimat tiotropium bromide and olodaterol SPRAY, METERED RESPIRATORY (INHALATION) 20150521 NDA NDA206756 Boehringer Ingelheim Pharmaceuticals Inc. TIOTROPIUM BROMIDE MONOHYDRATE; OLODATEROL HYDROCHLORIDE 3.124; 2.736 ug/1; ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],beta2-Adrenergic Agonist [EPC],Adrenergic beta2-Agonists [MoA] N 20181231 0597-0159_1aa66ec7-2ae0-8ea3-5f20-2da7c33245c6 0597-0159 HUMAN PRESCRIPTION DRUG Synjardy empagliflozin and metformin hydrochloride TABLET ORAL 20150826 NDA NDA206111 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0597-0160_7c99bf78-d9e2-1b8e-e5ec-d56593430923 0597-0160 HUMAN PRESCRIPTION DRUG Spiriva Respimat tiotropium bromide inhalation spray SPRAY, METERED RESPIRATORY (INHALATION) 20150915 NDA NDA207070 Boehringer Ingelheim Pharmaceuticals, Inc. TIOTROPIUM BROMIDE 1.562 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0597-0162_eee652f0-fe73-1fe6-563f-91385b21bce1 0597-0162 HUMAN OTC DRUG Dulcolax Bisacodyl SUPPOSITORY RECTAL 20130805 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals, Inc. BISACODYL 10 mg/1 N 20181231 0597-0164_18607943-d85c-5f83-72de-c73c8236eb37 0597-0164 HUMAN PRESCRIPTION DRUG Glyxambi empagliflozin and linagliptin TABLET, FILM COATED ORAL 20150130 NDA NDA206073 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN; LINAGLIPTIN 25; 5 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] N 20191231 0597-0165_a16ccb30-ea57-b5fa-985c-cc0fe546d19d 0597-0165 HUMAN OTC DRUG DulcoGas simethicone TABLET, CHEWABLE ORAL 20140228 OTC MONOGRAPH FINAL part332 Boehringer Ingelheim Pharmaceuticals, Inc. DIMETHICONE 125 mg/1 N 20181231 0597-0168_1aa66ec7-2ae0-8ea3-5f20-2da7c33245c6 0597-0168 HUMAN PRESCRIPTION DRUG Synjardy empagliflozin and metformin hydrochloride TABLET ORAL 20150826 NDA NDA206111 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 12.5; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0597-0169_8c58de13-78c0-a5b4-eb63-3f5263cc2b56 0597-0169 HUMAN OTC DRUG Dulcolax Pink bisacodyl TABLET, COATED ORAL 20120623 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals Inc. BISACODYL 5 mg/1 N 20181231 0597-0170_a16ccb30-ea57-b5fa-985c-cc0fe546d19d 0597-0170 HUMAN OTC DRUG DulcoGas simethicone TABLET, CHEWABLE ORAL 20140228 OTC MONOGRAPH FINAL part332 Boehringer Ingelheim Pharmaceuticals, Inc. DIMETHICONE 125 mg/1 N 20181231 0597-0175_1aa66ec7-2ae0-8ea3-5f20-2da7c33245c6 0597-0175 HUMAN PRESCRIPTION DRUG Synjardy empagliflozin and metformin hydrochloride TABLET ORAL 20150826 NDA NDA206111 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0597-0180_1aa66ec7-2ae0-8ea3-5f20-2da7c33245c6 0597-0180 HUMAN PRESCRIPTION DRUG Synjardy empagliflozin and metformin hydrochloride TABLET ORAL 20150826 NDA NDA206111 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 12.5; 500 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0597-0182_18607943-d85c-5f83-72de-c73c8236eb37 0597-0182 HUMAN PRESCRIPTION DRUG Glyxambi empagliflozin and linagliptin TABLET, FILM COATED ORAL 20150130 NDA NDA206073 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN; LINAGLIPTIN 10; 5 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] N 20191231 0597-0183_f045dd1f-c273-4427-6b3b-0c64011f30d1 0597-0183 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0184_f045dd1f-c273-4427-6b3b-0c64011f30d1 0597-0184 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0185_f045dd1f-c273-4427-6b3b-0c64011f30d1 0597-0185 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0186_a16ccb30-ea57-b5fa-985c-cc0fe546d19d 0597-0186 HUMAN OTC DRUG DulcoGas simethicone TABLET, CHEWABLE ORAL 20140410 OTC MONOGRAPH FINAL part332 Boehringer Ingelheim Pharmaceuticals, Inc. DIMETHICONE 125 mg/1 N 20181231 0597-0190_f045dd1f-c273-4427-6b3b-0c64011f30d1 0597-0190 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0191_f045dd1f-c273-4427-6b3b-0c64011f30d1 0597-0191 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0192_8f0d33cf-7cb8-0605-7f82-ce46e453d103 0597-0192 HUMAN PRESCRIPTION DRUG Striverdi Respimat olodaterol respimat inhalation spray SPRAY, METERED RESPIRATORY (INHALATION) 20140801 NDA NDA203108 Boehringer Ingelheim Pharmaceuticals, Inc. OLODATEROL HYDROCHLORIDE 2.5 ug/1 beta2-Adrenergic Agonist [EPC],Adrenergic beta2-Agonists [MoA] N 20181231 0597-0197_979be189-6765-fb1a-e1a2-933fd93c3c3b 0597-0197 HUMAN PRESCRIPTION DRUG Praxbind idarucizumab INJECTION INTRAVENOUS 20151021 BLA BLA761025 Boehringer Ingelheim Pharmaceuticals, Inc. IDARUCIZUMAB 50 mg/mL Humanized Monoclonal Antibody Fragment [EPC],Antibodies, Monoclonal, Humanized [Chemical/Ingredient] N 20181231 0597-0260_ddb60ccd-e41c-4a52-a84d-f164073f3fec 0597-0260 HUMAN PRESCRIPTION DRUG GlucaGen glucagon hydrochloride KIT 20050622 NDA NDA020918 Boehringer Ingelheim Pharmaceuticals, Inc. N 20181231 0597-0270_7d0a946d-453b-82b9-3613-6b21ab5987fa 0597-0270 HUMAN PRESCRIPTION DRUG Jentadueto XR linagliptin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160527 NDA NDA208026 Boehringer Ingelheim Pharmaceuticals, Inc. LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0597-0275_7d0a946d-453b-82b9-3613-6b21ab5987fa 0597-0275 HUMAN PRESCRIPTION DRUG Jentadueto XR linagliptin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160527 NDA NDA208026 Boehringer Ingelheim Pharmaceuticals, Inc. LINAGLIPTIN; METFORMIN HYDROCHLORIDE 5; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0597-0280_284a12b9-ccd6-44a7-a1a1-ad8cd46d2782 0597-0280 HUMAN PRESCRIPTION DRUG Synjardy XR empagliflozin, metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20161210 NDA NDA208658 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 10; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0597-0285_b69ea7f6-1c60-801c-1e34-e61a9f28c559 0597-0285 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20100222 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0286_b69ea7f6-1c60-801c-1e34-e61a9f28c559 0597-0286 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20110618 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 2.25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0287_b69ea7f6-1c60-801c-1e34-e61a9f28c559 0597-0287 HUMAN PRESCRIPTION DRUG Mirapex ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20110618 NDA NDA022421 Boehringer Ingelheim Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 3.75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0597-0290_284a12b9-ccd6-44a7-a1a1-ad8cd46d2782 0597-0290 HUMAN PRESCRIPTION DRUG Synjardy XR empagliflozin, metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20161210 NDA NDA208658 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 5; 1000 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] N 20181231 0597-0295_284a12b9-ccd6-44a7-a1a1-ad8cd46d2782 0597-0295 HUMAN PRESCRIPTION DRUG Synjardy XR empagliflozin, metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20161210 NDA NDA208658 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 25; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0597-0300_284a12b9-ccd6-44a7-a1a1-ad8cd46d2782 0597-0300 HUMAN PRESCRIPTION DRUG Synjardy XR empagliflozin, metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20161210 NDA NDA208658 Boehringer Ingelheim Pharmaceuticals, Inc. EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE 12.5; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0597-0315_f8d3d1af-f0af-6e4b-32df-44813c642a46 0597-0315 HUMAN OTC DRUG DUO Fusion Famotidine, Calcium carbonate, Magnesium hydroxide TABLET, CHEWABLE ORAL 20160301 ANDA ANDA077355 Boehringer Ingelheim Pharmaceuticals, Inc. FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 0597-0320_f4b7ba25-e6fd-9cd9-707a-6526ae37e96b 0597-0320 HUMAN OTC DRUG DUO Fusion Famotidine, Calcium carbonate, Magnesium hydroxide TABLET, CHEWABLE ORAL 20160301 ANDA ANDA077355 Boehringer Ingelheim Pharmaceuticals, Inc. FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 0597-0330_4ecfae3d-e883-5663-6ea6-046e92916247 0597-0330 HUMAN OTC DRUG DulcoEase Docusate sodium CAPSULE, LIQUID FILLED ORAL 20160701 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 0597-0335_8c58de13-78c0-a5b4-eb63-3f5263cc2b56 0597-0335 HUMAN OTC DRUG Dulcolax Pink bisacodyl TABLET, COATED ORAL 20160225 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals Inc. BISACODYL 5 mg/1 N 20181231 0597-0340_c19de20b-31cd-d123-f954-199e1499b941 0597-0340 HUMAN OTC DRUG Dulcolax bisacodyl TABLET, COATED ORAL 20130801 OTC MONOGRAPH NOT FINAL part334 Boehringer Ingelheim Pharmaceuticals, Inc. BISACODYL 5 mg/1 N 20181231 0597-0355_cc1eb28e-8ad7-ba33-594a-8ca2cc1768f0 0597-0355 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20110808 NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 75 mg/1 N 20181231 0597-0360_cc1eb28e-8ad7-ba33-594a-8ca2cc1768f0 0597-0360 HUMAN PRESCRIPTION DRUG Pradaxa dabigatran etexilate mesylate CAPSULE ORAL 20170728 NDA NDA022512 Boehringer Ingelheim Pharmaceuticals Inc. DABIGATRAN ETEXILATE MESYLATE 150 mg/1 N 20181231 0603-0024_4552c7db-7a5e-4d25-b09b-a13c26cef7f8 0603-0024 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH FINAL part343 Qualitest Pharmaceutical, Inc. ASPIRIN 81 mg/1 E 20171231 0603-0026_5f6d89ef-0c30-4eb3-afda-34550ce4783b 0603-0026 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH FINAL part343 Qualitest Pharmaceuticals ASPIRIN 81 mg/1 N 20181231 0603-0149_1178f066-6616-4f14-8fec-86b14b1b026f 0603-0149 HUMAN OTC DRUG DocQLax senna and docusate sodium TABLET, FILM COATED ORAL 20070726 20200531 OTC MONOGRAPH NOT FINAL part334 Par Pharmaceutical DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 0603-0150_97fd49a9-3242-4dc7-b676-bf4b9f547dad 0603-0150 HUMAN OTC DRUG DocQLace docusate sodium CAPSULE ORAL 20110801 OTC MONOGRAPH NOT FINAL part334 Qualitest Pharmaceuticals DOCUSATE SODIUM 100 mg/1 E 20171231 0603-0168_1edfbcc1-db1b-47b3-9d05-20027155097b 0603-0168 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceutical, Inc. ASPIRIN 325 mg/1 E 20171231 0603-0169_9230731c-88c6-4fb4-9546-b67d67ccf78f 0603-0169 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength TABLET ORAL 20110204 OTC MONOGRAPH FINAL part343 Qualitest Pharmaceuticals ASPIRIN 325 mg/1 N 20181231 0603-0179_ea79d1ca-3e31-42da-967b-bfd4e0948d58 0603-0179 HUMAN OTC DRUG FERROUS SULFATE IRON SUPPLEMENT TABLET ORAL 20010219 20200330 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals FERROUS SULFATE 325 mg/1 N 20181231 0603-0209_84235f82-3b3d-4c50-af24-942c9dc7ca68 0603-0209 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20031203 OTC MONOGRAPH FINAL part331 Qualitest Pharmaceuticals MAGNESIUM OXIDE 400 mg/1 N 20181231 0603-0210_03c6cf11-6d9a-4571-852c-16dda04b3bf8 0603-0210 HUMAN OTC DRUG MYTAB For GAS Simethicone TABLET, CHEWABLE ORAL 19990312 OTC MONOGRAPH FINAL part332 Qualitest Pharmaceuticals DIMETHICONE 80 mg/1 N 20181231 0603-0211_1ba7aeb2-42fc-4a99-a7cc-c2b3ac4efd6d 0603-0211 HUMAN OTC DRUG MAXIMUM STRENGTH MYTAB For GAS Simethicone TABLET, CHEWABLE ORAL 19990312 OTC MONOGRAPH FINAL part332 Qualitest Pharmaceuticals DIMETHICONE 125 mg/1 N 20181231 0603-0213_2d97b2b3-e1ad-498f-8f7c-69b2d7cc073d 0603-0213 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20031006 OTC MONOGRAPH FINAL part331 Qualitest Pharmaceuticals MAGNESIUM OXIDE 253 mg/1 E 20171231 0603-0235_69d8744b-aab2-439c-977a-29e5f435b55a 0603-0235 HUMAN OTC DRUG Pink Bismuth bismuth subsalicylate TABLET, CHEWABLE ORAL 20030428 OTC MONOGRAPH FINAL part335 Qualitest Pharmaceuticals BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 0603-0241_1963b638-e889-422a-8be7-6ae205e0d27d 0603-0241 HUMAN OTC DRUG Q-DRYL Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 20180531 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0603-0263_94cb48cf-3750-4a86-bee9-81365114776c 0603-0263 HUMAN OTC DRUG Regular Strength QPAP Acetaminophen TABLET ORAL 20110602 20180731 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 325 mg/1 N 20181231 0603-0268_02e28975-0a1e-49fb-9d67-1cb229f7d4ce 0603-0268 HUMAN OTC DRUG Extra Strength QPAP Acetaminophen TABLET ORAL 20110602 20180731 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 500 mg/1 N 20181231 0603-0282_05d87232-ca08-4577-aa26-3be40f6b9381 0603-0282 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 19960127 20220228 OTC MONOGRAPH NOT FINAL part334 Par Pharmaceutical SENNOSIDES A AND B 8.6 mg/1 N 20181231 0603-0283_8ae458b5-3454-4c80-89b3-fbb6773d06e6 0603-0283 HUMAN OTC DRUG SennaLax-S senna and docusate sodium TABLET, FILM COATED ORAL 20070726 20200630 OTC MONOGRAPH NOT FINAL part334 Par Pharmaceutical DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 0603-0441_d02212b1-668c-4601-b980-56e5772074ae 0603-0441 HUMAN OTC DRUG Bacitracin zinc bacitracin zinc OINTMENT TOPICAL 20010901 20180531 OTC MONOGRAPH FINAL part333B Qualitest Pharmaceuticals BACITRACIN ZINC 500 [USP'U]/g N 20181231 0603-0535_51e57f41-25cf-4884-9633-7d7cd6e11d79 0603-0535 HUMAN OTC DRUG Hydrocortisone hydrocortisone CREAM TOPICAL 20011001 20201031 OTC MONOGRAPH NOT FINAL part348 Par Pharmaceutical HYDROCORTISONE 10 mg/g N 20181231 0603-0599_29af6442-541e-44a5-97bc-d85572e9d81b 0603-0599 HUMAN OTC DRUG Povidone-Iodine povidone-iodine OINTMENT TOPICAL 19970801 20180315 OTC MONOGRAPH NOT FINAL part333A Qualitest Pharmaceuticals POVIDONE-IODINE 1 g/100g N 20181231 0603-0648_d732853e-3aa6-4f36-b5dc-960e3b472001 0603-0648 HUMAN OTC DRUG Trixaicin Capsicum oleoresin CREAM TOPICAL 19951201 20180228 OTC MONOGRAPH NOT FINAL part348 Qualitest Pharmaceuticals CAPSICUM OLEORESIN .25 mg/g N 20181231 0603-0823_471320f5-eccd-4c05-886c-28e9c0a1f67a 0603-0823 HUMAN OTC DRUG Qdryl Allergy Diphenhydramine Hydrochloride SOLUTION ORAL 19971201 20191031 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 0603-0841_3db4239a-1928-49ec-985e-7ffb0a4d8e7a 0603-0841 HUMAN OTC DRUG Childrens QPAP acetaminophen SUSPENSION ORAL 20000901 20180430 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 160 mg/5mL N 20181231 0603-0842_1e346f31-eab0-49a8-b6a3-2a3c036532f6 0603-0842 HUMAN OTC DRUG Childrens QPAP acetaminophen SUSPENSION ORAL 20000901 20180430 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 160 mg/5mL N 20181231 0603-0843_0af79ad8-db5f-42c8-8922-5d42a67b4862 0603-0843 HUMAN OTC DRUG Childrens QPAP acetaminophen SUSPENSION ORAL 20000901 20180531 OTC MONOGRAPH NOT FINAL part343 Qualitest Pharmaceuticals ACETAMINOPHEN 160 mg/5mL N 20181231 0603-0855_e541b053-fa12-48d5-931d-547184cce6b2 0603-0855 HUMAN OTC DRUG Q Tussin DM Dextromethorphan HBr and Guaifenesin SYRUP ORAL 19950401 20180331 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 0603-0857_05d150a8-736c-4555-bac7-9d3feb6b2dc8 0603-0857 HUMAN OTC DRUG QTussin Guaifenesin SOLUTION ORAL 19971001 20180720 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals GUAIFENESIN 100 mg/5mL N 20181231 0603-1075_6f71ed18-ad57-4497-b647-35c847320e8e 0603-1075 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 19960901 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV N 20181231 0603-1161_5fb2b33b-da29-118b-e053-2991aa0a46bc 0603-1161 HUMAN PRESCRIPTION DRUG dicyclomine hydrochloride dicyclomine hydrochloride SOLUTION ORAL 20050623 ANDA ANDA040169 Par Pharmaceutical DICYCLOMINE HYDROCHLORIDE 10 mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0603-1328_94078a95-0888-4263-adc0-1a6c80097f20 0603-1328 HUMAN OTC DRUG Iophen NR guaifenesin LIQUID ORAL 19970501 20180720 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals GUAIFENESIN 100 mg/5mL N 20181231 0603-1330_9d402429-5743-4457-9d53-1a0c1a0a1a5e 0603-1330 HUMAN OTC DRUG Iophen DM NR dextromethorphan and guaifenesin SOLUTION ORAL 19970501 20180829 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 0603-1378_0568b62a-29fb-4f3c-a74a-da6bcd9eb0e7 0603-1378 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20010726 ANDA ANDA075993 Qualitest Pharmaceuticals LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 0603-1384_f6f1e411-e832-4ba1-9a92-c451b802c3c5 0603-1384 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20120411 20190531 ANDA ANDA090079 Par Pharmaceutical LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0603-1393_b4677290-b60f-4f8f-848e-224cac2d993e 0603-1393 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION OROPHARYNGEAL 20070227 20180531 ANDA ANDA040708 Par Pharmaceutical LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 0603-1449_7a0a4256-7b4b-44ac-b91b-279335cdc280 0603-1449 HUMAN PRESCRIPTION DRUG Multi-Vit with Fluoride dl-alpha-tocopheryl acetate and ascorbic acid and cholecalciferol and cyanocobalamin and niacinamide and pyridoxine hydrochloride and riboflavin and fluoride and thiamine hydrochloride and vitamin A palmitate SOLUTION ORAL 19970418 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 8; .4; 2; .25 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 0603-1450_4f521e00-8cad-4143-8780-453bfcc5fd9f 0603-1450 HUMAN PRESCRIPTION DRUG Multi-Vit with Fluoride vitamin a palmitate and ascorbic acid and cholecalciferol and .alpha.-tocopherol acetate, dl- and thiamine hydrochloride and riboflavin and niacinamide and pyridoxine hydrochloride and cyanocobalamin and sodium fluoride SOLUTION ORAL 19970619 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 8; .4; 2; .5 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 0603-1452_90b27785-61ef-48a9-ab54-57df9af6c097 0603-1452 HUMAN PRESCRIPTION DRUG Multi-Vit with Fluoride and Iron vitamin a palmitate and ascorbic acid and cholecalciferol and .alpha.-tocopherol acetate, dl- and thiamine hydrochloride and riboflavin and niacinamide and pyridoxine hydrochloride and ferrous sulfate and sodium fluoride SOLUTION ORAL 19980107 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FERROUS SULFATE; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 8; .4; 10; .25 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 0603-1481_e3f1f5b7-50bb-4ce8-b785-168ed186c5f0 0603-1481 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20050628 ANDA ANDA065148 Qualitest Pharmaceuticals NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0603-1508_d1d6e3c1-841b-481a-92c9-b0b542410e48 0603-1508 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital ELIXIR ORAL 19970101 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals PHENOBARBITAL 20 mg/5mL CIV N 20181231 0603-1520_f53e4bac-9013-4c02-995f-a8b281b0ca6e 0603-1520 HUMAN OTC DRUG Phenylhistine DH chlorpheniramine maleate and codeine phosphate and pseudoephedrine hcl LIQUID ORAL 19961001 20180430 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 10; 30 mg/5mL; mg/5mL; mg/5mL CV N 20181231 0603-1542_57e4a2d2-6468-45f3-a6d8-f97f82b7a005 0603-1542 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride SOLUTION ORAL 20150504 NDA NDA206814 Par Pharmaceutical POTASSIUM CHLORIDE 20 meq/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0603-1543_57e4a2d2-6468-45f3-a6d8-f97f82b7a005 0603-1543 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride SOLUTION ORAL 20150504 NDA NDA206814 Par Pharmaceutical POTASSIUM CHLORIDE 40 meq/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0603-1554_79f47238-b8c3-4c3f-937b-fd155fc6672f 0603-1554 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride POWDER, FOR SOLUTION ORAL 20150918 NDA NDA208019 Par Pharmaceutical POTASSIUM CHLORIDE 1.5 g/1.58g Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0603-1567_318f21d5-6414-4804-ae2f-d97de6cfde6a 0603-1567 HUMAN PRESCRIPTION DRUG PrednisoLONE Prednisolone SYRUP ORAL 20070921 ANDA ANDA040775 Qualitest Pharmaceuticals PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0603-1584_0a48cffc-ba6c-4110-a330-5034e143175f 0603-1584 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SOLUTION ORAL 20060426 ANDA ANDA040643 Par Pharmaceutical PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0603-1585_d558875f-0a36-412a-b465-eacffddf3d58 0603-1585 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SOLUTION ORAL 20060131 ANDA ANDA040650 Par Pharmaceutical PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 0603-1586_8ede559f-a4bd-4b8a-a10b-970a142b7b08 0603-1586 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SOLUTION ORAL 20060214 ANDA ANDA040649 Par Pharmaceutical DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0603-1587_c7b5c14c-d0e4-4c68-94f0-d847a0405162 0603-1587 HUMAN PRESCRIPTION DRUG Promethazine VC Promethazine hydrochloride and phenylephrine hydrochloride SOLUTION ORAL 20061207 ANDA ANDA040654 Par Pharmaceutical PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 5 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] N 20181231 0603-1588_35c405f0-dcf0-4bb6-a773-86c79921d17f 0603-1588 HUMAN PRESCRIPTION DRUG Promethazine VC with Codeine Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate SOLUTION ORAL 20061207 ANDA ANDA040660 Par Pharmaceutical CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 10; 6.25; 5 mg/5mL; mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CV N 20181231 0603-1785_178dadf1-d460-4015-bc7a-7f260a231599 0603-1785 HUMAN PRESCRIPTION DRUG Tri-Vit with Fluoride Drops ascorbic acid and cholecalciferol and sodium fluoride and vitamin A palmitate SOLUTION ORAL 19950401 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; SODIUM FLUORIDE 1500; 35; 400; .25 [iU]/mL; mg/mL; [iU]/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 0603-1786_95ab821b-157c-4d83-b5e0-82d01d2362a6 0603-1786 HUMAN PRESCRIPTION DRUG Tri-Vit with Fluoride Drops ascorbic acid and cholecalciferol and sodium fluoride and vitamin A palmitate SOLUTION ORAL 19950401 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; SODIUM FLUORIDE 1500; 35; 400; .5 [iU]/mL; mg/mL; [iU]/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 0603-1787_383a57ec-c5ae-4886-9923-bd34cf53c932 0603-1787 HUMAN PRESCRIPTION DRUG Tri-Vit With Fluoride And Iron Drops vitamin a palmitate and ascorbic acid and cholecalciferol and ferrous sulfate and sodium fluoride SOLUTION ORAL 19971117 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; FERROUS SULFATE; SODIUM FLUORIDE 1500; 35; 400; 10; .25 [iU]/mL; mg/mL; [iU]/mL; mg/mL; mg/mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] N 20181231 0603-1841_a6f07b55-4bfb-46d3-9f9b-c4a1392ac752 0603-1841 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 20061013 ANDA ANDA077960 Par Pharmaceutical VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0603-1880_18437651-970f-4137-a60e-9db82bd7d780 0603-1880 HUMAN PRESCRIPTION DRUG Lidocaine lidocaine PATCH CUTANEOUS 20140502 NDA AUTHORIZED GENERIC NDA020612 Par Pharmaceutical LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 0603-2108_a55667bc-dbfc-4185-b677-49f762bdd3c3 0603-2108 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Par Pharmaceutical AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0603-2109_a55667bc-dbfc-4185-b677-49f762bdd3c3 0603-2109 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Par Pharmaceutical AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0603-2110_a55667bc-dbfc-4185-b677-49f762bdd3c3 0603-2110 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Par Pharmaceutical AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0603-2115_d2dad2a8-9be7-4119-b731-5c92568feda3 0603-2115 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Par Pharmaceutical ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0603-2116_d2dad2a8-9be7-4119-b731-5c92568feda3 0603-2116 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Par Pharmaceutical ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0603-2212_545c52cd-672f-45f5-a53d-80060719fd1f 0603-2212 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Par Pharmaceutical AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0603-2213_545c52cd-672f-45f5-a53d-80060719fd1f 0603-2213 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Par Pharmaceutical AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0603-2214_545c52cd-672f-45f5-a53d-80060719fd1f 0603-2214 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Par Pharmaceutical AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0603-2215_545c52cd-672f-45f5-a53d-80060719fd1f 0603-2215 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Par Pharmaceutical AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0603-2216_545c52cd-672f-45f5-a53d-80060719fd1f 0603-2216 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Par Pharmaceutical AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0603-2217_545c52cd-672f-45f5-a53d-80060719fd1f 0603-2217 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Par Pharmaceutical AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0603-2337_bc276c5d-f9af-46ff-bc83-a2640555ef77 0603-2337 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089990 Par Pharmaceutical CODEINE PHOSPHATE; ACETAMINOPHEN 15; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0603-2338_65df0dbd-a46e-4cfa-9786-8322c3db28d6 0603-2338 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Par Pharmaceutical CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0603-2339_65df0dbd-a46e-4cfa-9786-8322c3db28d6 0603-2339 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089828 Par Pharmaceutical CODEINE PHOSPHATE; ACETAMINOPHEN 60; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0603-2406_4b5db9c5-933a-48c5-9b1c-434c2d5d8720 0603-2406 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077156 Par Pharmaceutical BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 0603-2407_4b5db9c5-933a-48c5-9b1c-434c2d5d8720 0603-2407 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077068 Par Pharmaceutical BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 0603-2433_3128a42c-ccf2-4d1c-a32f-873035d3be50 0603-2433 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040738 Qualitest Pharmaceuticals BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0603-2434_3128a42c-ccf2-4d1c-a32f-873035d3be50 0603-2434 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040742 Qualitest Pharmaceuticals BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0603-2435_3128a42c-ccf2-4d1c-a32f-873035d3be50 0603-2435 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040715 Qualitest Pharmaceuticals BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0603-2437_3928aaa7-027c-483d-aec9-e70715ba6706 0603-2437 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20170515 ANDA ANDA204713 Par Pharmaceutical BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0603-2438_3928aaa7-027c-483d-aec9-e70715ba6706 0603-2438 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20170515 ANDA ANDA204713 Par Pharmaceutical BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0603-2439_3928aaa7-027c-483d-aec9-e70715ba6706 0603-2439 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20170515 ANDA ANDA204713 Par Pharmaceutical BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0603-2540_dd3452e3-ab9f-4bca-a961-ce6c4e1a8475 0603-2540 HUMAN PRESCRIPTION DRUG butalbital and acetaminophen butalbital and acetaminophen TABLET ORAL 19990603 ANDA ANDA089987 Par Pharmaceutical BUTALBITAL; ACETAMINOPHEN 50; 325 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20191231 0603-2544_71ba1572-1e3d-4136-a948-d1bbc4e518a4 0603-2544 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 Par Pharmaceutical BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0603-2553_b4cd8d4f-4941-4fa5-916d-3dbbf8c77fff 0603-2553 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20020422 ANDA ANDA075929 Par Pharmaceutical BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0603-2582_0932ad07-f38b-41b6-b475-4c803a8c66d1 0603-2582 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Par Pharmaceutical CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 0603-2948_1f4b636f-6584-4050-a74f-1af44eab10c7 0603-2948 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 20190930 ANDA ANDA077856 Qualitest Pharmaceuticals CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0603-2949_1f4b636f-6584-4050-a74f-1af44eab10c7 0603-2949 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 20180228 ANDA ANDA077856 Qualitest Pharmaceuticals CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0603-2950_1f4b636f-6584-4050-a74f-1af44eab10c7 0603-2950 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 20180430 ANDA ANDA077856 Qualitest Pharmaceuticals CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0603-2957_612ff712-bec7-42a3-949e-ad67167087ee 0603-2957 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 20180923 ANDA ANDA077901 Qualitest Pharmaceuticals CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0603-3078_ca664865-1628-4ec2-b95b-2cbe1ae6c2d5 0603-3078 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 20180731 ANDA ANDA077797 Qualitest Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0603-3079_ca664865-1628-4ec2-b95b-2cbe1ae6c2d5 0603-3079 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 20181031 ANDA ANDA077797 Qualitest Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0603-3162_5388184f-b372-47e2-b255-0aafc8232bdb 0603-3162 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100604 ANDA ANDA040756 Par Pharmaceutical FOLIC ACID 1 mg/1 N 20181231 0603-3213_a958507e-7d1f-4f85-87c4-d8a68b8f37a4 0603-3213 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 20180331 ANDA ANDA077749 Qualitest Pharmaceuticals DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0603-3215_a958507e-7d1f-4f85-87c4-d8a68b8f37a4 0603-3215 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 20190831 ANDA ANDA077749 Qualitest Pharmaceuticals DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0603-3339_005c82c4-4e5e-40dc-bf7c-81d6dd3eef0d 0603-3339 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 20200330 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0603-3340_18b7f80f-2c4a-4ba6-9334-87a03f6211c9 0603-3340 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 20180630 OTC MONOGRAPH FINAL part341 Qualitest Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 0603-3508_60e0812c-717b-5551-e053-2991aa0a2f68 0603-3508 HUMAN PRESCRIPTION DRUG Effervescent Potassium Chloride Potassium Bicarbonate and Potassium Chloride Effervescent Tablets for Oral Solution TABLET, EFFERVESCENT ORAL 20060106 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals POTASSIUM CHLORIDE; POTASSIUM BICARBONATE; LYSINE HYDROCHLORIDE 1.25; .7; 1.5 g/1; g/1; g/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0603-3581_caa21eb5-24a9-444a-82e4-230a9eb24794 0603-3581 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20090331 ANDA ANDA200815 Qualitest Pharmaceuticals FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0603-3582_caa21eb5-24a9-444a-82e4-230a9eb24794 0603-3582 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20111215 ANDA ANDA200815 Qualitest Pharmaceuticals FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0603-3583_caa21eb5-24a9-444a-82e4-230a9eb24794 0603-3583 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111215 ANDA ANDA200815 Qualitest Pharmaceuticals FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0603-3584_65d30eb3-08a0-4fb2-9c42-83658a35f915 0603-3584 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20061106 ANDA ANDA077727 Par Pharmaceutical HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 0603-3586_65d30eb3-08a0-4fb2-9c42-83658a35f915 0603-3586 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20061106 ANDA ANDA077723 Par Pharmaceutical HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 0603-3590_bb80395c-704c-473d-9b22-1e5ee6ce0adc 0603-3590 HUMAN PRESCRIPTION DRUG Gildagia norethindrone and ethinyl estradiol KIT 20121223 ANDA ANDA078376 Par Pharmaceutical N 20181231 0603-3609_f46bace1-6957-4556-bc31-e3a08fa47238 0603-3609 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20160429 20190131 ANDA ANDA040355 Par Pharmaceutical HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0603-3633_5a76ad5c-6af1-4040-ad7d-a66f61168eca 0603-3633 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20061222 20180228 ANDA ANDA077251 Qualitest Pharmaceuticals FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 0603-3718_7a23bb88-5dcc-489f-a63e-fb986730414f 0603-3718 HUMAN PRESCRIPTION DRUG Frovatriptan Succinate frovatriptan succinate TABLET, FILM COATED ORAL 20151005 NDA NDA021006 Qualitest Pharmaceuticals FROVATRIPTAN SUCCINATE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0603-3739_d458aacc-128c-4f5c-ad1a-badb983f8895 0603-3739 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 20180930 ANDA ANDA076796 Qualitest Pharmaceuticals FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0603-3740_d458aacc-128c-4f5c-ad1a-badb983f8895 0603-3740 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 20180930 ANDA ANDA076796 Qualitest Pharmaceuticals FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0603-3741_d458aacc-128c-4f5c-ad1a-badb983f8895 0603-3741 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 20180731 ANDA ANDA076796 Qualitest Pharmaceuticals FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0603-3744_4de65ece-39be-451a-baa0-824cb807f827 0603-3744 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20101014 20180922 ANDA ANDA077370 Qualitest Pharmaceuticals GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0603-3745_4de65ece-39be-451a-baa0-824cb807f827 0603-3745 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20101014 20180430 ANDA ANDA077370 Qualitest Pharmaceuticals GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0603-3746_4de65ece-39be-451a-baa0-824cb807f827 0603-3746 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20101014 20180922 ANDA ANDA077370 Qualitest Pharmaceuticals GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0603-3855_5875068a-1d62-4290-8a8b-ebd0f84c1d79 0603-3855 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20020917 20180331 ANDA ANDA075907 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0603-3856_5a90dc91-61da-42fb-b37a-8cfc28549dad 0603-3856 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 20180926 ANDA ANDA040412 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0603-3857_5a90dc91-61da-42fb-b37a-8cfc28549dad 0603-3857 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 20180922 ANDA ANDA040412 Qualitest Pharmaceuticals HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0603-3887_ab81dc5f-e71c-4071-8bfa-f8c8597b9a18 0603-3887 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Par Pharmaceutical HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0603-3890_ab81dc5f-e71c-4071-8bfa-f8c8597b9a18 0603-3890 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Par Pharmaceutical HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0603-3891_ab81dc5f-e71c-4071-8bfa-f8c8597b9a18 0603-3891 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Par Pharmaceutical HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0603-3897_65d30eb3-08a0-4fb2-9c42-83658a35f915 0603-3897 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20061106 ANDA ANDA077723 Par Pharmaceutical HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 0603-3899_ac4f3f02-c0a1-4cab-ae2f-5f0c33bdcea7 0603-3899 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20070716 ANDA ANDA040761 Par Pharmaceutical HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0603-3900_ac4f3f02-c0a1-4cab-ae2f-5f0c33bdcea7 0603-3900 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20070716 ANDA ANDA040761 Par Pharmaceutical HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0603-3901_ac4f3f02-c0a1-4cab-ae2f-5f0c33bdcea7 0603-3901 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20070716 ANDA ANDA040761 Par Pharmaceutical HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0603-4110_778bf261-3e7b-41b2-b62b-c80c670f0d92 0603-4110 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 Par Pharmaceutical ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0603-4111_778bf261-3e7b-41b2-b62b-c80c670f0d92 0603-4111 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 Par Pharmaceutical ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0603-4112_778bf261-3e7b-41b2-b62b-c80c670f0d92 0603-4112 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 Par Pharmaceutical ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0603-4170_ecdd65cd-25d6-401a-b925-fb1652999167 0603-4170 HUMAN PRESCRIPTION DRUG K-EFFERVESCENT POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20060106 UNAPPROVED DRUG OTHER Qualitest Pharmaceuticals POTASSIUM BICARBONATE 25 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0603-4209_4d4ec08c-e47b-4141-8802-cadeb46c8078 0603-4209 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Par Pharmaceutical LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0603-4210_4d4ec08c-e47b-4141-8802-cadeb46c8078 0603-4210 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Par Pharmaceutical LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0603-4211_4d4ec08c-e47b-4141-8802-cadeb46c8078 0603-4211 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Par Pharmaceutical LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0603-4212_4d4ec08c-e47b-4141-8802-cadeb46c8078 0603-4212 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Par Pharmaceutical LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0603-4213_4d4ec08c-e47b-4141-8802-cadeb46c8078 0603-4213 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Par Pharmaceutical LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0603-4214_4d4ec08c-e47b-4141-8802-cadeb46c8078 0603-4214 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Par Pharmaceutical LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0603-4246_edb6bd5c-c008-48f6-abf3-cdcec988190c 0603-4246 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20060510 20200530 ANDA ANDA077754 Qualitest Pharmaceuticals LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0603-4247_edb6bd5c-c008-48f6-abf3-cdcec988190c 0603-4247 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 20180719 ANDA ANDA077754 Qualitest Pharmaceuticals LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0603-4248_edb6bd5c-c008-48f6-abf3-cdcec988190c 0603-4248 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 20180531 ANDA ANDA077754 Qualitest Pharmaceuticals LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0603-4415_ffa7869a-37c0-4e04-b4ba-0dad72d59fab 0603-4415 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19981217 20180228 ANDA ANDA040191 Qualitest Pharmaceuticals MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0603-4485_96ed63b7-bc1b-442a-8a00-2ce5cc484b55 0603-4485 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Par Pharmaceutical METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0603-4486_96ed63b7-bc1b-442a-8a00-2ce5cc484b55 0603-4486 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Par Pharmaceutical METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0603-4576_dcb99344-cb01-4e7d-a2cc-f6a3043748f3 0603-4576 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 20140923 ANDA ANDA202892 Par Pharmaceutical METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0603-4577_dcb99344-cb01-4e7d-a2cc-f6a3043748f3 0603-4577 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 20140923 ANDA ANDA202892 Par Pharmaceutical METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0603-4578_dcb99344-cb01-4e7d-a2cc-f6a3043748f3 0603-4578 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 20140923 ANDA ANDA202892 Par Pharmaceutical METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0603-4593_6e0ce2e3-b2f4-4111-9fe8-268e1a0f1a32 0603-4593 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 19981222 ANDA ANDA040183 Par Pharmaceutical METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0603-4653_cd4e5cea-b0b3-4d3f-ad8c-84b4c98690ad 0603-4653 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA091588 Par Pharmaceutical MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0603-4654_cd4e5cea-b0b3-4d3f-ad8c-84b4c98690ad 0603-4654 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA091588 Par Pharmaceutical MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0603-4655_cd4e5cea-b0b3-4d3f-ad8c-84b4c98690ad 0603-4655 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA091576 Par Pharmaceutical MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0603-4890_205c7bd5-da9a-4e8e-8f3c-62de90a2bdb4 0603-4890 HUMAN OTC DRUG ORGAN I NR Guaifenesin TABLET ORAL 20150427 20181231 OTC MONOGRAPH FINAL part341 Par Pharmaceutical GUAIFENESIN 200 mg/1 N 20181231 0603-4975_f099fddd-bd9f-4b6b-96fc-9cc794dd93d2 0603-4975 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 Par Pharmaceutical OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0603-4978_4f089405-0777-48f3-9bea-d848c916cb6e 0603-4978 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20130711 ANDA ANDA090733 Par Pharmaceutical OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0603-4979_ed9c9356-1e34-49da-bca7-e70b6106b98c 0603-4979 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20130711 ANDA ANDA090734 Par Pharmaceutical OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0603-4982_ed9c9356-1e34-49da-bca7-e70b6106b98c 0603-4982 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20130711 ANDA ANDA090734 Par Pharmaceutical OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0603-4990_57aec2fb-b161-422a-9426-ddda461aea4b 0603-4990 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20090302 ANDA ANDA077712 Par Pharmaceutical OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0603-4991_57aec2fb-b161-422a-9426-ddda461aea4b 0603-4991 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20070131 ANDA ANDA077712 Par Pharmaceutical OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0603-4992_57aec2fb-b161-422a-9426-ddda461aea4b 0603-4992 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20070131 ANDA ANDA077712 Par Pharmaceutical OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0603-4993_57aec2fb-b161-422a-9426-ddda461aea4b 0603-4993 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20150413 ANDA ANDA077712 Par Pharmaceutical OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0603-4994_57aec2fb-b161-422a-9426-ddda461aea4b 0603-4994 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20150413 ANDA ANDA077712 Par Pharmaceutical OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0603-4998_7611c14d-6af5-466e-bd2c-2047295c20b7 0603-4998 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 19960730 ANDA ANDA040105 Par Pharmaceutical OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0603-5060_a7fde5ce-5777-45ab-be84-00ed52c689a7 0603-5060 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Par Pharmaceutical PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0603-5061_a7fde5ce-5777-45ab-be84-00ed52c689a7 0603-5061 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Par Pharmaceutical PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0603-5062_a7fde5ce-5777-45ab-be84-00ed52c689a7 0603-5062 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Par Pharmaceutical PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0603-5063_a7fde5ce-5777-45ab-be84-00ed52c689a7 0603-5063 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Par Pharmaceutical PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0603-5165_782740a3-0a3a-48f5-a1c8-ac77c18bb750 0603-5165 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20020301 UNAPPROVED DRUG OTHER Par Pharmaceutical PHENOBARBITAL 16.2 mg/1 CIV N 20181231 0603-5166_782740a3-0a3a-48f5-a1c8-ac77c18bb750 0603-5166 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20030201 UNAPPROVED DRUG OTHER Par Pharmaceutical PHENOBARBITAL 32.4 mg/1 CIV N 20181231 0603-5167_782740a3-0a3a-48f5-a1c8-ac77c18bb750 0603-5167 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20011201 UNAPPROVED DRUG OTHER Par Pharmaceutical PHENOBARBITAL 64.8 mg/1 CIV N 20181231 0603-5168_782740a3-0a3a-48f5-a1c8-ac77c18bb750 0603-5168 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20011201 UNAPPROVED DRUG OTHER Par Pharmaceutical PHENOBARBITAL 97.2 mg/1 CIV N 20181231 0603-5335_475278bd-63cf-4ce1-9869-f5dc833bf8fb 0603-5335 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20041221 ANDA ANDA040584 Par Pharmaceutical PREDNISONE 1 mg/1 N 20181231 0603-5336_475278bd-63cf-4ce1-9869-f5dc833bf8fb 0603-5336 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20041221 ANDA ANDA040581 Par Pharmaceutical PREDNISONE 2.5 mg/1 N 20181231 0603-5337_475278bd-63cf-4ce1-9869-f5dc833bf8fb 0603-5337 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Par Pharmaceutical PREDNISONE 5 mg/1 N 20181231 0603-5338_475278bd-63cf-4ce1-9869-f5dc833bf8fb 0603-5338 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Par Pharmaceutical PREDNISONE 10 mg/1 N 20181231 0603-5339_475278bd-63cf-4ce1-9869-f5dc833bf8fb 0603-5339 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 Par Pharmaceutical PREDNISONE 20 mg/1 N 20181231 0603-5371_2260f305-65aa-4d97-bd2d-9974dc3f3572 0603-5371 HUMAN PRESCRIPTION DRUG Primidone primidone TABLET ORAL 20050224 ANDA ANDA040586 Par Pharmaceutical PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0603-5372_2260f305-65aa-4d97-bd2d-9974dc3f3572 0603-5372 HUMAN PRESCRIPTION DRUG Primidone primidone TABLET ORAL 20050224 ANDA ANDA040586 Par Pharmaceutical PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0603-5437_a0c79862-2b12-4dcc-a69b-72800d08b597 0603-5437 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060718 20180531 ANDA ANDA040622 Qualitest Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0603-5438_a0c79862-2b12-4dcc-a69b-72800d08b597 0603-5438 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060718 20180430 ANDA ANDA040622 Qualitest Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0603-5439_a0c79862-2b12-4dcc-a69b-72800d08b597 0603-5439 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060718 20180928 ANDA ANDA040622 Qualitest Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0603-5448_99389c61-2175-4fd3-8dbc-61644a4e3099 0603-5448 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride TABLET, FILM COATED ORAL 20021017 ANDA ANDA075938 Par Pharmaceutical PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] N 20181231 0603-5449_99389c61-2175-4fd3-8dbc-61644a4e3099 0603-5449 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride TABLET, FILM COATED ORAL 20021017 ANDA ANDA075938 Par Pharmaceutical PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] N 20181231 0603-5450_99389c61-2175-4fd3-8dbc-61644a4e3099 0603-5450 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride TABLET, FILM COATED ORAL 20021017 ANDA ANDA075938 Par Pharmaceutical PROPAFENONE HYDROCHLORIDE 300 mg/1 Antiarrhythmic [EPC] N 20181231 0603-5482_79b1602c-1153-4791-9b1e-4744d88cb95c 0603-5482 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070217 Par Pharmaceutical PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0603-5483_79b1602c-1153-4791-9b1e-4744d88cb95c 0603-5483 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070218 Par Pharmaceutical PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0603-5484_79b1602c-1153-4791-9b1e-4744d88cb95c 0603-5484 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070219 Par Pharmaceutical PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0603-5485_79b1602c-1153-4791-9b1e-4744d88cb95c 0603-5485 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070220 Par Pharmaceutical PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0603-5486_79b1602c-1153-4791-9b1e-4744d88cb95c 0603-5486 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070221 Par Pharmaceutical PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0603-5763_3f67bfee-57f1-4c32-a0e0-5b4e375a5a64 0603-5763 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Par Pharmaceutical SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0603-5764_3f67bfee-57f1-4c32-a0e0-5b4e375a5a64 0603-5764 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Par Pharmaceutical SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0603-5765_3f67bfee-57f1-4c32-a0e0-5b4e375a5a64 0603-5765 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Par Pharmaceutical SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0603-5769_edee4670-3d56-40ea-b3a0-9dc9489089b0 0603-5769 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Qualitest Pharmaceuticals SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0603-5770_edee4670-3d56-40ea-b3a0-9dc9489089b0 0603-5770 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Qualitest Pharmaceuticals SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0603-5771_edee4670-3d56-40ea-b3a0-9dc9489089b0 0603-5771 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Qualitest Pharmaceuticals SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0603-5772_edee4670-3d56-40ea-b3a0-9dc9489089b0 0603-5772 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Qualitest Pharmaceuticals SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0603-5801_ffd0c2fa-4b84-4ab3-8694-9d555d446bae 0603-5801 HUMAN PRESCRIPTION DRUG Sulfasalazine sulfasalazine TABLET ORAL 20020111 20190731 ANDA ANDA040349 Qualitest Pharmaceuticals SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0603-5803_f57fe9ed-d8e8-45b6-8174-c8f1f3bb8b4d 0603-5803 HUMAN PRESCRIPTION DRUG Sulfasalazine Delayed-Release sulfasalazine TABLET, DELAYED RELEASE ORAL 20020111 20180930 ANDA ANDA075339 Qualitest Pharmaceuticals SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 0603-5892_d912ca54-6569-4e58-a8ef-620eddd03163 0603-5892 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20150731 20180430 ANDA ANDA201781 Qualitest Pharmaceuticals TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0603-5894_d912ca54-6569-4e58-a8ef-620eddd03163 0603-5894 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20150731 20180331 ANDA ANDA201781 Qualitest Pharmaceuticals TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0603-6160_44580dac-153d-4d76-b5b3-f0860f24f9fd 0603-6160 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072192 Par Pharmaceutical TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 0603-6161_44580dac-153d-4d76-b5b3-f0860f24f9fd 0603-6161 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072193 Par Pharmaceutical TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 0603-6240_804d513a-9772-4925-92a3-b6f0462b7d86 0603-6240 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 19981224 20191231 ANDA ANDA040254 Qualitest Pharmaceuticals TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 0603-6241_804d513a-9772-4925-92a3-b6f0462b7d86 0603-6241 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 19981224 20180228 ANDA ANDA040254 Qualitest Pharmaceuticals TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 N 20181231 0603-6330_31edb5ce-5732-4f44-af59-7940cac2f0cd 0603-6330 HUMAN PRESCRIPTION DRUG Valganciclovir Valganciclovir hydrochloride TABLET, FILM COATED ORAL 20141104 ANDA ANDA200790 Qualitest Pharmaceuticals VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 0603-7512_f4f6c8c3-011a-4a7c-919c-99aedc2e4021 0603-7512 HUMAN PRESCRIPTION DRUG Kimidess desogestrel and ethinyl estradiol KIT 20150608 ANDA ANDA076681 Par Pharmaceutical N 20181231 0603-7521_27f1c896-c517-4fba-bc56-960e48c0f4f6 0603-7521 HUMAN PRESCRIPTION DRUG Cyclafem 1/35 norethindrone and ethinyl estradiol KIT 20101112 ANDA ANDA076337 Par Pharmaceutical N 20181231 0603-7525_7a50f41f-e832-406d-ac78-12f6bf458d10 0603-7525 HUMAN PRESCRIPTION DRUG Cyclafem 7/7/7 norethindrone and ethinyl estradiol KIT 20101116 ANDA ANDA076338 Par Pharmaceutical N 20181231 0603-7540_41b0a4eb-acf3-46fc-9e77-b4f106bf9ea6 0603-7540 HUMAN PRESCRIPTION DRUG Emoquette desogestrel and ethinyl estradiol KIT 20110225 ANDA ANDA076675 Par Pharmaceutical N 20181231 0603-7606_2f9ea569-030d-49fc-9181-0594d07bab53 0603-7606 HUMAN PRESCRIPTION DRUG Gildess 1.5/30 norethindrone acetate and ethinyl estradiol TABLET, FILM COATED ORAL 20120724 20180331 ANDA ANDA077075 Par Pharmaceutical NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1.5; .03 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0603-7607_7c07d958-3b0c-4de7-92a5-5b2b11df152a 0603-7607 HUMAN PRESCRIPTION DRUG Gildess 1/20 norethindrone acetate and ethinyl estradiol TABLET, FILM COATED ORAL 20120724 20180331 ANDA ANDA077077 Par Pharmaceutical NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; .02 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0603-7625_a6704385-24e6-412c-a02c-7c39521a3145 0603-7625 HUMAN PRESCRIPTION DRUG Myzilra Levonorgestrel and Ethinyl Estradiol KIT 20120112 ANDA ANDA077502 Par Pharmaceutical N 20181231 0603-7634_f01765d0-0f2d-481b-90cc-b643e641a294 0603-7634 HUMAN PRESCRIPTION DRUG Orsythia levonorgestrel and ethinyl estradiol KIT ORAL 20110511 ANDA ANDA077099 Par Pharmaceutical N 20181231 0603-7642_96c9eb17-287d-449d-aff6-72ec749d288a 0603-7642 HUMAN PRESCRIPTION DRUG Previfem norgestimate and ethinyl estradiol KIT 20040109 ANDA ANDA076334 Par Pharmaceutical N 20181231 0603-7663_d022dc91-a37f-4c29-8e94-3364156f3c66 0603-7663 HUMAN PRESCRIPTION DRUG Tri Previfem norgestimate and ethinyl estradiol KIT 20040326 ANDA ANDA076335 Par Pharmaceutical N 20181231 0603-7781_b4a01027-d3c9-4c70-aab7-d5de322d92ff 0603-7781 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone CREAM TOPICAL 20040312 20200831 ANDA ANDA040503 Par Pharmaceutical HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0603-7785_8ccb19ce-f50d-4d56-9cc9-30b13554ab1c 0603-7785 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone LOTION TOPICAL 20030730 20181231 ANDA ANDA040417 Par Pharmaceutical HYDROCORTISONE 25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0603-7818_030dbc84-588f-477f-99e3-4f6cac5b3de1 0603-7818 HUMAN PRESCRIPTION DRUG Nystatin nystatin CREAM TOPICAL 20060531 ANDA ANDA065315 Qualitest Pharmaceuticals NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0603-7831_df004aec-f611-421c-8016-35492ded1ab3 0603-7831 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL, METERED TOPICAL 20140825 NDA AUTHORIZED GENERIC NDA021463 Par Pharmaceutical TESTOSTERONE 10 mg/.5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0603-7861_e883d95f-c8aa-46f2-8fe0-a3b74cbbd6ff 0603-7861 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide CREAM TOPICAL 20060609 ANDA ANDA040671 Qualitest Pharmaceuticals TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0603-7862_e883d95f-c8aa-46f2-8fe0-a3b74cbbd6ff 0603-7862 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide CREAM TOPICAL 20060609 ANDA ANDA040671 Qualitest Pharmaceuticals TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0603-7864_ceaf475f-68ea-42b1-9de4-fed34eade160 0603-7864 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide LOTION TOPICAL 20061213 ANDA ANDA040672 Qualitest Pharmaceuticals TRIAMCINOLONE ACETONIDE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0603-9171_edba0d01-d72e-48de-9528-9ddf9fd1a838 0603-9171 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin SUSPENSION ORAL 20101008 20180228 ANDA ANDA065438 Qualitest Pharmaceuticals GRISEOFULVIN 125 mg/5mL Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 0603-9418_55bd4292-85c8-418c-9e36-452b455adb0c 0603-9418 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SOLUTION ORAL 20100701 20180331 ANDA ANDA078890 Par Pharmaceutical RANITIDINE HYDROCHLORIDE 75 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0603-9424_846bc4c8-74ce-4730-b44b-53abeeb7e077 0603-9424 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20101203 20190731 ANDA ANDA079158 Par Pharmaceutical RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 0615-0170_e4d076e6-157c-4596-b575-ae4a6b9bda4e 0615-0170 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 NCS HealthCare of KY, Inc dba Vangard Labs SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0615-0326_1e900e41-8b74-41fe-b99e-88dd030c11b7 0615-0326 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 NCS HealthCare of KY, Inc dba Vangard Labs AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 0615-0327_a539d618-2eae-41d6-8e00-b48d001c00fa 0615-0327 HUMAN PRESCRIPTION DRUG Dicyclomine dicyclomine hydrochloride CAPSULE ORAL 19970228 ANDA ANDA040204 NCS HealthCare of KY, Inc dba Vangard Labs DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0615-0331_45db7593-81bf-4a29-ba13-c86cd4fb3d8f 0615-0331 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA087479 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0615-0332_b075d1a9-8d2b-4a0b-96a4-95841830e2bf 0615-0332 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0615-0362_e656793c-1438-4803-a636-95feb2546c3c 0615-0362 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20121012 ANDA ANDA072741 NCS HealthCare of KY, Inc dba Vangard Labs LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 0615-0378_9328e83b-c249-40bd-82fb-376b8ccd9739 0615-0378 HUMAN OTC DRUG Docusate Calcium Docusate Calcium CAPSULE ORAL 20111201 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE CALCIUM 240 mg/1 N 20181231 0615-0446_7c5111c8-7a8c-4e90-b257-4379b7d469de 0615-0446 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831130 NDA NDA018413 NCS HealthCare of KY, Inc dba Vangard Labs FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0615-0516_1cce9fcb-74f7-4f96-a546-5572b96d4d7c 0615-0516 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19821005 ANDA ANDA087836 NCS HealthCare of KY, Inc dba Vangard Labs HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 0615-0518_794757db-646d-414a-9faa-d444e7116780 0615-0518 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 NCS HealthCare of KY, Inc dba Vangard Labs DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0615-0522_5c38d339-bd06-4c99-b177-c7addf73557f 0615-0522 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20090930 OTC MONOGRAPH FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ASPIRIN 325 mg/1 N 20181231 0615-0531_1cce9fcb-74f7-4f96-a546-5572b96d4d7c 0615-0531 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19800227 ANDA ANDA086961 NCS HealthCare of KY, Inc dba Vangard Labs HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 0615-0532_1cce9fcb-74f7-4f96-a546-5572b96d4d7c 0615-0532 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19800227 ANDA ANDA086962 NCS HealthCare of KY, Inc dba Vangard Labs HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 0615-0536_979dbb63-0414-4a5c-9451-cbc196e87f4c 0615-0536 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 NCS HealthCare of KY, Inc dba Vangard Labs PREDNISONE 5 mg/1 N 20181231 0615-0547_f002a62a-bf93-4ec8-b88a-91683b3e19ce 0615-0547 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 NCS HealthCare of KY, Inc dba Vangard Labs DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0615-0564_1e23707d-f41d-486e-b4b3-c0d3dec32a55 0615-0564 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ASPIRIN 325 mg/1 N 20181231 0615-0585_058f0cf7-469c-4aa0-a95f-4f53de559d45 0615-0585 HUMAN OTC DRUG Docusate Sodium DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100423 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE SODIUM 100 mg/1 N 20181231 0615-0586_fbf5de0e-45c0-4ba9-8557-70d82de4e3ae 0615-0586 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE SODIUM 250 mg/1 N 20181231 0615-0591_9407a884-50af-4df0-9102-ef2cfd1ec259 0615-0591 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110421 OTC MONOGRAPH NOT FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN 325 mg/1 N 20181231 0615-0598_8f2fa151-2171-45dc-bd2a-6e7ae4248156 0615-0598 HUMAN OTC DRUG Bisacodyl Bisacodyl Enteric Coated TABLET, COATED ORAL 19930902 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs BISACODYL 5 mg/1 N 20181231 0615-0675_8a4dc266-81f7-46aa-8c90-24cece8f55af 0615-0675 HUMAN PRESCRIPTION DRUG Trihexyphenidyl hydrochloride Trihexyphenidyl hydrochloride TABLET ORAL 19980206 ANDA ANDA040184 NCS HealthCare of KY, Inc dba Vangard Labs TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 0615-0676_8a4dc266-81f7-46aa-8c90-24cece8f55af 0615-0676 HUMAN PRESCRIPTION DRUG Trihexyphenidyl hydrochloride Trihexyphenidyl hydrochloride TABLET ORAL 19980206 ANDA ANDA040184 NCS HealthCare of KY, Inc dba Vangard Labs TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 N 20181231 0615-0828_ac604638-a8d2-4925-b940-8387dc27d488 0615-0828 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 NCS HealthCare of KY, Inc dba Vangard Labs AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0615-0829_ac604638-a8d2-4925-b940-8387dc27d488 0615-0829 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 NCS HealthCare of KY, Inc dba Vangard Labs AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0615-0830_ac604638-a8d2-4925-b940-8387dc27d488 0615-0830 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 NCS HealthCare of KY, Inc dba Vangard Labs AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0615-1308_c8974e25-2da4-4113-b7ef-4707587488c3 0615-1308 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin CAPSULE ORAL 19970709 ANDA ANDA074967 NCS HealthCare of KY, Inc dba Vangard Labs NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 0615-1311_332d9499-f831-4d29-9270-43370119d957 0615-1311 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19801126 NDA NDA017812 NCS HealthCare of KY, Inc dba Vangard Labs LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 0615-1318_d281058f-5ff7-40d2-a872-03dc73896ec8 0615-1318 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium CAPSULE ORAL 20080602 ANDA ANDA077419 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 N 20181231 0615-1324_c5453821-e9e9-4ae2-a3e1-9d1b51b420b5 0615-1324 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-1325_bd2301b2-796e-4c1b-a18d-dfd03bc22fef 0615-1325 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE ORAL 19911029 ANDA ANDA073229 NCS HealthCare of KY, Inc dba Vangard Labs VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-1333_194a19cf-d20f-43f0-b279-e23b8e23f540 0615-1333 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide triamterene and hydrochlorothiazide CAPSULE ORAL 20110504 ANDA ANDA074701 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 0615-1337_c93083f1-b1e9-42cb-8c53-f715c70297c6 0615-1337 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin CAPSULE ORAL 19980330 ANDA ANDA074823 NCS HealthCare of KY, Inc dba Vangard Labs TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0615-1338_8dcbb073-d3d6-4c00-9e59-6edb07d2c144 0615-1338 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 19980330 ANDA ANDA074823 NCS HealthCare of KY, Inc dba Vangard Labs TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0615-1339_8dcbb073-d3d6-4c00-9e59-6edb07d2c144 0615-1339 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 19980303 ANDA ANDA074823 NCS HealthCare of KY, Inc dba Vangard Labs TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0615-1341_c5453821-e9e9-4ae2-a3e1-9d1b51b420b5 0615-1341 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-1342_c5453821-e9e9-4ae2-a3e1-9d1b51b420b5 0615-1342 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-1343_963929bb-80d0-4b86-a6e1-555f6985af57 0615-1343 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20091120 ANDA ANDA040298 NCS HealthCare of KY, Inc dba Vangard Labs PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0615-1349_af8036bf-eecc-4e91-a66c-e6bf5dbb8f79 0615-1349 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20101114 ANDA ANDA081297 NCS HealthCare of KY, Inc dba Vangard Labs BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 0615-1354_06184a4a-2e68-4ec7-93b0-637d75ea1d1d 0615-1354 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 19971022 ANDA ANDA074655 NCS HealthCare of KY, Inc dba Vangard Labs RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0615-1355_c5453821-e9e9-4ae2-a3e1-9d1b51b420b5 0615-1355 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-1357_22cc492e-e9ec-4d88-baf7-e6f81fa597d5 0615-1357 HUMAN PRESCRIPTION DRUG fluoxetine fluoxetine hydrochloride CAPSULE ORAL 20100429 ANDA ANDA075245 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-1358_96e5457c-c9e8-47f9-bcec-a530cf80969a 0615-1358 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0615-1359_d8c173e5-5cd0-4243-8599-e9fc0bd57acc 0615-1359 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20030128 ANDA ANDA075757 NCS HealthCare of KY, Inc dba Vangard Labs OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0615-1374_d56397c5-a066-4e2d-bc5a-11b61057db4c 0615-1374 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 19871231 NDA NDA019594 NCS HealthCare of KY, Inc dba Vangard Labs URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 0615-1376_d8df25f8-fbd2-41e4-b5b2-a4b10ddd67b2 0615-1376 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20030912 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-1377_d8df25f8-fbd2-41e4-b5b2-a4b10ddd67b2 0615-1377 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20030912 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-1378_d8df25f8-fbd2-41e4-b5b2-a4b10ddd67b2 0615-1378 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20030912 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-1379_b15b9eb1-288c-49b6-bc25-520791b5f6fb 0615-1379 HUMAN PRESCRIPTION DRUG Zonisamide zonisamide CAPSULE ORAL 20121022 ANDA ANDA077637 NCS HealthCare of KY, Inc dba Vangard Labs ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0615-1384_58fe7d20-4803-4761-9098-d859806b0564 0615-1384 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080520 ANDA ANDA076287 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-1387_8e35dc0e-bf0e-49d8-b5a7-7b76d5829795 0615-1387 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20020129 ANDA ANDA075049 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-1393_cffab85a-db8d-4087-b840-e54fc19aad6b 0615-1393 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium CAPSULE ORAL 20090123 ANDA ANDA078979 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-1397_d9910f83-8c88-4269-a518-60d97c2d4ff2 0615-1397 HUMAN PRESCRIPTION DRUG amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0615-1398_d9910f83-8c88-4269-a518-60d97c2d4ff2 0615-1398 HUMAN PRESCRIPTION DRUG amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0615-1399_d9910f83-8c88-4269-a518-60d97c2d4ff2 0615-1399 HUMAN PRESCRIPTION DRUG amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0615-1501_6209ef07-f7bc-49f1-a034-d6900275db01 0615-1501 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 NCS HealthCare of KY, Inc dba Vangard Labs FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-1504_06ca0dcb-5a5c-4104-b38f-b964fbcca08c 0615-1504 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110718 ANDA ANDA074201 NCS HealthCare of KY, Inc dba Vangard Labs NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-1511_7a721f27-95ce-4e0b-9a93-8cc3d8f6e188 0615-1511 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE AcetaZOLAMIDE TABLET ORAL 19970528 ANDA ANDA040195 NCS HealthCare of KY, Inc dba Vangard Labs ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 0615-1516_fb4f04ea-4c2b-4f25-aa59-22ff246ee2a3 0615-1516 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 NCS HealthCare of KY, Inc dba Vangard Labs DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0615-1525_b6d71446-c2be-4930-8dcf-bb6690512c2a 0615-1525 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070320 ANDA ANDA040786 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0615-1526_b6d71446-c2be-4930-8dcf-bb6690512c2a 0615-1526 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070320 ANDA ANDA040786 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0615-1527_b6d71446-c2be-4930-8dcf-bb6690512c2a 0615-1527 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070320 ANDA ANDA040786 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0615-1535_c811c81f-84d9-4d55-bbd4-2b30a6e5a32d 0615-1535 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20010820 ANDA ANDA040424 NCS HealthCare of KY, Inc dba Vangard Labs SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0615-1536_4a02f757-be72-4d37-b1a1-a6d8fd716fd7 0615-1536 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20100108 ANDA ANDA087056 NCS HealthCare of KY, Inc dba Vangard Labs CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 0615-1539_909a1473-2a2f-4ee1-94aa-a4b62a7fafdc 0615-1539 HUMAN PRESCRIPTION DRUG Promethazine Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 NCS HealthCare of KY, Inc dba Vangard Labs PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-1542_bff5ebfc-cfba-4130-b971-26b98a38e026 0615-1542 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 NCS HealthCare of KY, Inc dba Vangard Labs PREDNISONE 20 mg/1 N 20181231 0615-1546_4d95826c-dfb7-4752-86ea-54f4b83e04aa 0615-1546 HUMAN PRESCRIPTION DRUG Chlorpromazine Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 NCS HealthCare of KY, Inc dba Vangard Labs CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-1547_4d95826c-dfb7-4752-86ea-54f4b83e04aa 0615-1547 HUMAN PRESCRIPTION DRUG Chlorpromazine Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 NCS HealthCare of KY, Inc dba Vangard Labs CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-1548_4d95826c-dfb7-4752-86ea-54f4b83e04aa 0615-1548 HUMAN PRESCRIPTION DRUG Chlorpromazine Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 NCS HealthCare of KY, Inc dba Vangard Labs CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-1553_9ad2f9a6-2561-4c9a-b258-893596dfdfa8 0615-1553 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087127 NCS HealthCare of KY, Inc dba Vangard Labs MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 0615-1554_9ad2f9a6-2561-4c9a-b258-893596dfdfa8 0615-1554 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 NCS HealthCare of KY, Inc dba Vangard Labs MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 0615-1556_b1041447-db42-4ca8-b2e6-287caf24c7f2 0615-1556 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 NCS HealthCare of KY, Inc dba Vangard Labs GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0615-1560_4b8ba147-c2a9-42df-b4f5-d76295409703 0615-1560 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086066 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-1561_e4155f64-58c6-43d2-a944-cad2b13e78ae 0615-1561 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0615-1562_e4155f64-58c6-43d2-a944-cad2b13e78ae 0615-1562 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0615-1569_7c5111c8-7a8c-4e90-b257-4379b7d469de 0615-1569 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831130 NDA NDA018413 NCS HealthCare of KY, Inc dba Vangard Labs FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0615-1571_60c97f84-e500-4de9-9e26-e5b2b9bf14e5 0615-1571 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 NCS HealthCare of KY, Inc dba Vangard Labs FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0615-1573_f26e686a-aa0a-4e50-a492-d25a3fe8c201 0615-1573 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20110123 ANDA ANDA087716 NCS HealthCare of KY, Inc dba Vangard Labs DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0615-1575_4b8ba147-c2a9-42df-b4f5-d76295409703 0615-1575 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19830426 ANDA ANDA088088 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-1576_d320471c-96fe-4559-83cd-333a6b2f3315 0615-1576 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19841220 ANDA ANDA070035 NCS HealthCare of KY, Inc dba Vangard Labs METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0615-1577_d320471c-96fe-4559-83cd-333a6b2f3315 0615-1577 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19841220 ANDA ANDA070035 NCS HealthCare of KY, Inc dba Vangard Labs METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0615-1590_9864e22b-201f-455d-9361-786fad14bb2f 0615-1590 HUMAN PRESCRIPTION DRUG Theophylline Extended Release Theophylline, anhydrous TABLET, EXTENDED RELEASE ORAL 19900430 ANDA ANDA089763 NCS HealthCare of KY, Inc dba Vangard Labs THEOPHYLLINE 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0615-1592_e35992df-3f72-4a3f-9a91-8987be959fad 0615-1592 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19861024 ANDA ANDA018659 NCS HealthCare of KY, Inc dba Vangard Labs ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0615-1593_e35992df-3f72-4a3f-9a91-8987be959fad 0615-1593 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19861024 ANDA ANDA018659 NCS HealthCare of KY, Inc dba Vangard Labs ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0615-2302_e3144ea7-4181-4efd-b95b-6fe3c6440cbf 0615-2302 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20071022 ANDA ANDA075576 NCS HealthCare of KY, Inc dba Vangard Labs OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0615-2303_938c3471-0c2e-43c2-88ba-ff5eb2e38fc3 0615-2303 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20080226 ANDA ANDA077728 NCS HealthCare of KY, Inc dba Vangard Labs CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0615-2304_332d9499-f831-4d29-9270-43370119d957 0615-2304 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870128 NDA NDA017812 NCS HealthCare of KY, Inc dba Vangard Labs LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] N 20181231 0615-2305_e3144ea7-4181-4efd-b95b-6fe3c6440cbf 0615-2305 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20071022 ANDA ANDA075576 NCS HealthCare of KY, Inc dba Vangard Labs OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0615-2503_282f24d5-31de-4b2e-8262-361119501b12 0615-2503 HUMAN PRESCRIPTION DRUG Theophylline Extended Release Theophylline, anhydrous TABLET, EXTENDED RELEASE ORAL 19900430 ANDA ANDA089808 NCS HealthCare of KY, Inc dba Vangard Labs THEOPHYLLINE 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0615-2513_bff5ebfc-cfba-4130-b971-26b98a38e026 0615-2513 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087801 NCS HealthCare of KY, Inc dba Vangard Labs PREDNISONE 2.5 mg/1 N 20181231 0615-2519_d7adb695-e703-4ec9-8517-b759d3bd3cf0 0615-2519 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20101213 ANDA ANDA040185 NCS HealthCare of KY, Inc dba Vangard Labs PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-2520_d7adb695-e703-4ec9-8517-b759d3bd3cf0 0615-2520 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20101213 ANDA ANDA040185 NCS HealthCare of KY, Inc dba Vangard Labs PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-2521_8757a56a-c01b-4d1d-93e1-3e18ec381daf 0615-2521 HUMAN PRESCRIPTION DRUG Primidone primidone TABLET ORAL 20060701 ANDA ANDA040667 NCS HealthCare of KY, Inc dba Vangard Labs PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-2525_c475ada9-5948-45e4-934f-571e46b9a38d 0615-2525 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 NCS HealthCare of KY, Inc dba Vangard Labs IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-2526_c475ada9-5948-45e4-934f-571e46b9a38d 0615-2526 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 NCS HealthCare of KY, Inc dba Vangard Labs IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-2528_c475ada9-5948-45e4-934f-571e46b9a38d 0615-2528 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 NCS HealthCare of KY, Inc dba Vangard Labs IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-2536_fa8e7ef1-a49a-4ab6-a158-11ef3dc1e583 0615-2536 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19851017 ANDA ANDA070581 NCS HealthCare of KY, Inc dba Vangard Labs METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0615-2542_caf8ff07-80d7-4722-a882-ad2a2e4e6ef4 0615-2542 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN 500 mg/1 N 20181231 0615-2547_727070e9-1e14-4aab-b015-75abd66cd910 0615-2547 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20100228 ANDA ANDA089058 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0615-2548_727070e9-1e14-4aab-b015-75abd66cd910 0615-2548 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20100228 ANDA ANDA089059 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0615-2549_727070e9-1e14-4aab-b015-75abd66cd910 0615-2549 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20100228 ANDA ANDA089060 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0615-2557_048ea5dc-4eeb-4bce-8047-a0eade2ae885 0615-2557 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20030929 ANDA ANDA040533 NCS HealthCare of KY, Inc dba Vangard Labs BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0615-2558_048ea5dc-4eeb-4bce-8047-a0eade2ae885 0615-2558 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20030929 ANDA ANDA040533 NCS HealthCare of KY, Inc dba Vangard Labs BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0615-2561_631fbd02-ac53-4b98-bda2-827ee4438c0d 0615-2561 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 NCS HealthCare of KY, Inc dba Vangard Labs PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-2562_631fbd02-ac53-4b98-bda2-827ee4438c0d 0615-2562 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 NCS HealthCare of KY, Inc dba Vangard Labs PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-2563_631fbd02-ac53-4b98-bda2-827ee4438c0d 0615-2563 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 NCS HealthCare of KY, Inc dba Vangard Labs PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-2572_72e958d1-cbc6-4c81-9ae0-7490e1908c0a 0615-2572 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19861216 ANDA ANDA070974 NCS HealthCare of KY, Inc dba Vangard Labs CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0615-2573_72e958d1-cbc6-4c81-9ae0-7490e1908c0a 0615-2573 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19861216 ANDA ANDA070975 NCS HealthCare of KY, Inc dba Vangard Labs CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0615-2574_72e958d1-cbc6-4c81-9ae0-7490e1908c0a 0615-2574 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19861216 ANDA ANDA070976 NCS HealthCare of KY, Inc dba Vangard Labs CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0615-2578_0ff7d0a2-f27f-4383-8736-bf6e9934c993 0615-2578 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071523 NCS HealthCare of KY, Inc dba Vangard Labs TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 0615-2579_0ff7d0a2-f27f-4383-8736-bf6e9934c993 0615-2579 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071524 NCS HealthCare of KY, Inc dba Vangard Labs TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 0615-2594_eff4b566-4acb-4f8b-8697-cdb78d7790f0 0615-2594 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20110113 ANDA ANDA070278 NCS HealthCare of KY, Inc dba Vangard Labs HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] N 20181231 0615-2595_eff4b566-4acb-4f8b-8697-cdb78d7790f0 0615-2595 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20110113 ANDA ANDA070278 NCS HealthCare of KY, Inc dba Vangard Labs HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] N 20181231 0615-2596_eff4b566-4acb-4f8b-8697-cdb78d7790f0 0615-2596 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20110113 ANDA ANDA070278 NCS HealthCare of KY, Inc dba Vangard Labs HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] N 20181231 0615-2597_eff4b566-4acb-4f8b-8697-cdb78d7790f0 0615-2597 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20110113 ANDA ANDA070278 NCS HealthCare of KY, Inc dba Vangard Labs HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 0615-2598_bbaf5f11-91e6-45ce-a15f-b26d498e456d 0615-2598 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19880311 ANDA ANDA071210 NCS HealthCare of KY, Inc dba Vangard Labs HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] N 20181231 0615-3505_067e666f-2b47-4b1d-8852-3e2737ae42ff 0615-3505 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19900930 ANDA ANDA070541 NCS HealthCare of KY, Inc dba Vangard Labs CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0615-3508_1eb5b95f-feda-47c6-aabe-b3376f9cf84f 0615-3508 HUMAN OTC DRUG Aspirin Chewable Aspirin Chewable TABLET ORAL 20071212 OTC MONOGRAPH NOT FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ASPIRIN 81 mg/1 N 20181231 0615-3512_a2906a86-446f-473d-b8b8-f720b6c5c661 0615-3512 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20121030 ANDA ANDA075079 NCS HealthCare of KY, Inc dba Vangard Labs OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0615-3520_3cdef1be-879c-49a7-817e-e4fdc171168c 0615-3520 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 NCS HealthCare of KY, Inc dba Vangard Labs CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0615-3527_bcd9b0c4-449c-4ccd-ab35-a9418e30625b 0615-3527 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20091216 ANDA ANDA071333 NCS HealthCare of KY, Inc dba Vangard Labs IBUPROFEN 200 mg/1 N 20181231 0615-3532_3159bdfa-9386-4eb9-8186-43788920c39c 0615-3532 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20130218 ANDA ANDA073457 NCS HealthCare of KY, Inc dba Vangard Labs ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-3533_2c9479d8-ddb7-4d42-93bb-cdc7be1ba8b1 0615-3533 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20120430 ANDA ANDA073457 NCS HealthCare of KY, Inc dba Vangard Labs ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-3537_bb5685d7-f3b0-4865-a525-c797b92977bd 0615-3537 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0615-3541_a97f4edc-c113-4f38-807c-4c832893d966 0615-3541 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072234 NCS HealthCare of KY, Inc dba Vangard Labs BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 0615-3542_a97f4edc-c113-4f38-807c-4c832893d966 0615-3542 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072235 NCS HealthCare of KY, Inc dba Vangard Labs BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 0615-3544_a340ebdc-4eb9-4ee2-8f14-5fb61bb9356e 0615-3544 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 NCS HealthCare of KY, Inc dba Vangard Labs ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-3548_65056a10-2b8a-422d-9c01-daf103203ed2 0615-3548 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20121204 ANDA ANDA072838 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-3549_65056a10-2b8a-422d-9c01-daf103203ed2 0615-3549 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20121204 ANDA ANDA072838 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-3550_65056a10-2b8a-422d-9c01-daf103203ed2 0615-3550 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20121204 ANDA ANDA072838 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-3551_65056a10-2b8a-422d-9c01-daf103203ed2 0615-3551 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20121204 ANDA ANDA072838 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-3552_2f6b97a8-7121-4bc7-9cd5-72d7f8ec8ef3 0615-3552 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-3553_2f6b97a8-7121-4bc7-9cd5-72d7f8ec8ef3 0615-3553 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-3559_26fa7a1a-4426-4f35-aeea-af695b8beb27 0615-3559 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19931124 ANDA ANDA074256 NCS HealthCare of KY, Inc dba Vangard Labs GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 0615-3561_bb5685d7-f3b0-4865-a525-c797b92977bd 0615-3561 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0615-3562_06ca0dcb-5a5c-4104-b38f-b964fbcca08c 0615-3562 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110718 ANDA ANDA074201 NCS HealthCare of KY, Inc dba Vangard Labs NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-3563_5a73a2a0-8ccf-4c23-8bc8-d7a2903ab7d5 0615-3563 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20101213 ANDA ANDA074201 NCS HealthCare of KY, Inc dba Vangard Labs NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-3568_8749bde6-9a51-4e60-93b8-d2e893e112b4 0615-3568 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20100805 OTC MONOGRAPH FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ASPIRIN 81 mg/1 N 20181231 0615-3570_32213700-b200-4a92-bb79-17291ff6ed18 0615-3570 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19880808 ANDA ANDA072423 NCS HealthCare of KY, Inc dba Vangard Labs MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0615-3574_6209ef07-f7bc-49f1-a034-d6900275db01 0615-3574 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 NCS HealthCare of KY, Inc dba Vangard Labs FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-3583_e1b364bf-91ef-4712-8b5e-a6dd86033d68 0615-3583 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19920430 ANDA ANDA073281 NCS HealthCare of KY, Inc dba Vangard Labs TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0615-3584_1a2048f4-f9ed-49e6-ab7d-c968120ff4e1 0615-3584 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089683 NCS HealthCare of KY, Inc dba Vangard Labs PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-3585_1a2048f4-f9ed-49e6-ab7d-c968120ff4e1 0615-3585 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089683 NCS HealthCare of KY, Inc dba Vangard Labs PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-3588_a6d634a2-1c0f-447e-b3fd-6b210acab42f 0615-3588 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120223 ANDA ANDA074330 NCS HealthCare of KY, Inc dba Vangard Labs VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0615-3589_a6d634a2-1c0f-447e-b3fd-6b210acab42f 0615-3589 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120223 ANDA ANDA073568 NCS HealthCare of KY, Inc dba Vangard Labs VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0615-3593_979dbb63-0414-4a5c-9451-cbc196e87f4c 0615-3593 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030213 ANDA ANDA084122 NCS HealthCare of KY, Inc dba Vangard Labs PREDNISONE 10 mg/1 N 20181231 0615-3595_792a3d71-8cb9-4c4c-84e8-9e1376787005 0615-3595 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19940510 ANDA ANDA074226 NCS HealthCare of KY, Inc dba Vangard Labs GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0615-3596_792a3d71-8cb9-4c4c-84e8-9e1376787005 0615-3596 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19940510 ANDA ANDA074226 NCS HealthCare of KY, Inc dba Vangard Labs GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0615-3599_f4616553-a74b-44cc-89f1-7772bb2c7bac 0615-3599 HUMAN PRESCRIPTION DRUG Klor Con M potassium chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0615-4504_bb5685d7-f3b0-4865-a525-c797b92977bd 0615-4504 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0615-4506_4d48eca9-541a-43b1-9345-23eeb66ca022 0615-4506 HUMAN PRESCRIPTION DRUG diclofenac sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 NCS HealthCare of KY, Inc dba Vangard Labs DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-4507_4d48eca9-541a-43b1-9345-23eeb66ca022 0615-4507 HUMAN PRESCRIPTION DRUG diclofenac sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 NCS HealthCare of KY, Inc dba Vangard Labs DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-4509_e12c79fb-5bd5-4310-81c2-2f4f9af0e160 0615-4509 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 NCS HealthCare of KY, Inc dba Vangard Labs GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0615-4510_4b359540-bccb-4df6-8321-1edbd2bf5acd 0615-4510 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN 500 mg/1 N 20191231 0615-4511_1a2048f4-f9ed-49e6-ab7d-c968120ff4e1 0615-4511 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089683 NCS HealthCare of KY, Inc dba Vangard Labs PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-4513_40dc2a98-5890-49c8-8299-be9225d8fc8b 0615-4513 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20091106 ANDA ANDA075165 NCS HealthCare of KY, Inc dba Vangard Labs RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0615-4514_40dc2a98-5890-49c8-8299-be9225d8fc8b 0615-4514 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20091106 ANDA ANDA075165 NCS HealthCare of KY, Inc dba Vangard Labs RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0615-4515_05a19461-16b8-443f-ab47-ff5c96e3694a 0615-4515 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20051207 ANDA ANDA077272 NCS HealthCare of KY, Inc dba Vangard Labs CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0615-4517_8ee62c16-abf6-426e-953e-dc06600b8deb 0615-4517 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20100108 ANDA ANDA070848 NCS HealthCare of KY, Inc dba Vangard Labs SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 0615-4519_84a4b2a6-23a5-411f-82ab-c1a8a5683ed9 0615-4519 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19970328 ANDA ANDA074532 NCS HealthCare of KY, Inc dba Vangard Labs CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-4520_84a4b2a6-23a5-411f-82ab-c1a8a5683ed9 0615-4520 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19970328 ANDA ANDA074532 NCS HealthCare of KY, Inc dba Vangard Labs CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-4521_84a4b2a6-23a5-411f-82ab-c1a8a5683ed9 0615-4521 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19970328 ANDA ANDA074532 NCS HealthCare of KY, Inc dba Vangard Labs CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-4523_e71a3614-e3ae-4979-b6d9-1556c2ca2161 0615-4523 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090921 ANDA ANDA074425 NCS HealthCare of KY, Inc dba Vangard Labs PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 0615-4529_365635c1-79ca-4322-a0d8-c232988dc965 0615-4529 HUMAN OTC DRUG Senna Laxative Sennosides TABLET, COATED ORAL 20110504 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs SENNOSIDES A AND B 8.6 mg/1 N 20181231 0615-4536_21a6d2e6-8373-4f3f-8274-84e888b1dd6d 0615-4536 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 NCS HealthCare of KY, Inc dba Vangard Labs BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0615-4539_923bfb04-e1ec-4651-8d15-a7f93a8e8b1c 0615-4539 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20100114 ANDA ANDA074787 NCS HealthCare of KY, Inc dba Vangard Labs LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-4544_80c1d483-2717-4090-a8ac-a2f9c85fbc5f 0615-4544 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060330 ANDA ANDA076813 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-4545_de784be2-7b76-4d45-81d0-624e80cffbee 0615-4545 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 19981223 ANDA ANDA075315 NCS HealthCare of KY, Inc dba Vangard Labs AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0615-4546_80c1d483-2717-4090-a8ac-a2f9c85fbc5f 0615-4546 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060330 ANDA ANDA076813 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-4554_7b855173-241d-4b52-8deb-520d3468bcd7 0615-4554 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110421 OTC MONOGRAPH NOT FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN 325 mg/1 N 20181231 0615-4568_5b049995-c25b-40e5-8750-739125ad1b51 0615-4568 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20111018 ANDA ANDA075091 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0615-4569_5b049995-c25b-40e5-8750-739125ad1b51 0615-4569 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20111018 ANDA ANDA075091 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0615-4575_f747d011-89e1-4729-9abf-9df3eed35894 0615-4575 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075385 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 0615-4582_8e053d18-4ca3-4aa7-a11b-07fe99f1c2cf 0615-4582 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100430 ANDA ANDA075511 NCS HealthCare of KY, Inc dba Vangard Labs FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0615-4589_759e0a98-9e32-4caf-936c-873ddf8b85b7 0615-4589 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NCS HealthCare of KY, Inc dba Vangard Labs ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0615-4590_759e0a98-9e32-4caf-936c-873ddf8b85b7 0615-4590 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NCS HealthCare of KY, Inc dba Vangard Labs ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0615-4591_759e0a98-9e32-4caf-936c-873ddf8b85b7 0615-4591 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NCS HealthCare of KY, Inc dba Vangard Labs ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0615-4593_759e0a98-9e32-4caf-936c-873ddf8b85b7 0615-4593 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NCS HealthCare of KY, Inc dba Vangard Labs ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0615-4594_c007c1bf-9f5c-4c09-a5bd-e2346d756998 0615-4594 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100430 ANDA ANDA075511 NCS HealthCare of KY, Inc dba Vangard Labs FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0615-4595_f747d011-89e1-4729-9abf-9df3eed35894 0615-4595 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075385 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 0615-4596_f747d011-89e1-4729-9abf-9df3eed35894 0615-4596 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075385 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 0615-5501_fb0613bf-4712-4563-aba8-a741a0e3f732 0615-5501 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine TABLET, FILM COATED ORAL 20100113 ANDA ANDA075755 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-5502_fb0613bf-4712-4563-aba8-a741a0e3f732 0615-5502 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine TABLET, FILM COATED ORAL 20100113 ANDA ANDA075755 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-5521_5b5d0c35-25e8-4b6f-ae4d-76374421cd74 0615-5521 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100420 ANDA ANDA075752 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-5527_a5ffabf4-205f-4770-b3e3-2b8e0d2d1371 0615-5527 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20121228 ANDA ANDA076122 NCS HealthCare of KY, Inc dba Vangard Labs MIRTAZAPINE 45 mg/1 N 20181231 0615-5530_5b5d0c35-25e8-4b6f-ae4d-76374421cd74 0615-5530 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100420 ANDA ANDA075752 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-5531_5b5d0c35-25e8-4b6f-ae4d-76374421cd74 0615-5531 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100420 ANDA ANDA075752 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-5532_8563c9ce-6096-413d-a45b-b3090d1f115c 0615-5532 HUMAN OTC DRUG Fiber Lax CALCIUM POLYCARBOPHIL TABLET, FILM COATED ORAL 20100901 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 0615-5533_e9986c17-4f29-4207-a82d-3f7323012bdc 0615-5533 HUMAN OTC DRUG Senna Plus Sennosides and Docusate Sodium TABLET ORAL 20110616 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 0615-5534_21a6d2e6-8373-4f3f-8274-84e888b1dd6d 0615-5534 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 NCS HealthCare of KY, Inc dba Vangard Labs BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0615-5535_be424ba7-c9ec-4eb0-853c-f56665fe0b9c 0615-5535 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-5536_ace11116-05af-4378-99bd-ee2f4b2aee75 0615-5536 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin mesylate TABLET ORAL 20001019 ANDA ANDA075509 NCS HealthCare of KY, Inc dba Vangard Labs DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0615-5537_ace11116-05af-4378-99bd-ee2f4b2aee75 0615-5537 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin mesylate TABLET ORAL 20001019 ANDA ANDA075509 NCS HealthCare of KY, Inc dba Vangard Labs DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0615-5538_5b5d0c35-25e8-4b6f-ae4d-76374421cd74 0615-5538 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100420 ANDA ANDA075752 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-5539_5b5d0c35-25e8-4b6f-ae4d-76374421cd74 0615-5539 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100420 ANDA ANDA075752 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-5540_5b5d0c35-25e8-4b6f-ae4d-76374421cd74 0615-5540 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100420 ANDA ANDA075752 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-5541_a90a7ddb-457e-4ab4-b63e-c9f3b186f26a 0615-5541 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100630 ANDA ANDA090649 NCS HealthCare of KY, Inc dba Vangard Labs NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0615-5548_8b1f1f00-8f73-4036-899d-4eb445910cb4 0615-5548 HUMAN PRESCRIPTION DRUG BusPIRone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20050601 ANDA ANDA075467 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 7.5 mg/1 N 20181231 0615-5549_20147b6e-d77f-4031-a5de-3f62383c7c14 0615-5549 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 19981030 ANDA ANDA075037 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-5550_20147b6e-d77f-4031-a5de-3f62383c7c14 0615-5550 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 19981030 ANDA ANDA075037 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-5552_7d61f28c-fe77-46c1-ace4-34b701ce4e5f 0615-5552 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 NCS HealthCare of KY, Inc dba Vangard Labs SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] E 20171231 0615-5554_be424ba7-c9ec-4eb0-853c-f56665fe0b9c 0615-5554 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-5559_f4616553-a74b-44cc-89f1-7772bb2c7bac 0615-5559 HUMAN PRESCRIPTION DRUG Klor Con M potassium chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0615-5572_561c8634-5635-4b66-a51a-b42da6817a07 0615-5572 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20121228 ANDA ANDA076122 NCS HealthCare of KY, Inc dba Vangard Labs MIRTAZAPINE 15 mg/1 N 20181231 0615-5573_561c8634-5635-4b66-a51a-b42da6817a07 0615-5573 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20121228 ANDA ANDA076122 NCS HealthCare of KY, Inc dba Vangard Labs MIRTAZAPINE 30 mg/1 N 20181231 0615-5574_7787774c-62ab-444e-82f1-aac29452ab8e 0615-5574 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 NCS HealthCare of KY, Inc dba Vangard Labs TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0615-5575_4d358ce1-40ae-4753-867e-b48d23dba2ef 0615-5575 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110719 ANDA ANDA076346 NCS HealthCare of KY, Inc dba Vangard Labs TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0615-5576_641d859d-3a27-4b7d-9c9f-e2b0cbb3a449 0615-5576 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070307 ANDA ANDA077584 NCS HealthCare of KY, Inc dba Vangard Labs PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-5577_641d859d-3a27-4b7d-9c9f-e2b0cbb3a449 0615-5577 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070307 ANDA ANDA077584 NCS HealthCare of KY, Inc dba Vangard Labs PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-5578_641d859d-3a27-4b7d-9c9f-e2b0cbb3a449 0615-5578 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070307 ANDA ANDA077584 NCS HealthCare of KY, Inc dba Vangard Labs PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-5579_641d859d-3a27-4b7d-9c9f-e2b0cbb3a449 0615-5579 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070307 ANDA ANDA077584 NCS HealthCare of KY, Inc dba Vangard Labs PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-5583_eb42803c-ac3f-418a-a5d7-cf81e479f8b1 0615-5583 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100611 ANDA ANDA076269 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0615-5584_04f7ce27-0809-4974-9850-7d1c10dd1ad5 0615-5584 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, EXTENDED RELEASE ORAL 20030908 ANDA ANDA076467 NCS HealthCare of KY, Inc dba Vangard Labs GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0615-5585_04f7ce27-0809-4974-9850-7d1c10dd1ad5 0615-5585 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, EXTENDED RELEASE ORAL 20030908 ANDA ANDA076467 NCS HealthCare of KY, Inc dba Vangard Labs GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0615-5586_4bd4aebe-5d12-43a7-b079-26bc93cebb63 0615-5586 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030121 ANDA ANDA075209 NCS HealthCare of KY, Inc dba Vangard Labs LORATADINE 10 mg/1 N 20181231 0615-5589_0466fea6-e576-4c71-943e-9ec5038f79a2 0615-5589 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-5591_4bd1672f-54df-4a23-a7cd-dd63d302abdc 0615-5591 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20010524 ANDA ANDA084903 NCS HealthCare of KY, Inc dba Vangard Labs PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-5592_c811c81f-84d9-4d55-bbd4-2b30a6e5a32d 0615-5592 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20010820 ANDA ANDA040424 NCS HealthCare of KY, Inc dba Vangard Labs SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0615-5593_5392708b-ded5-44c8-87cd-afe79564794b 0615-5593 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041028 ANDA ANDA076832 NCS HealthCare of KY, Inc dba Vangard Labs LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 0615-5619_cbebe8fd-aaea-4564-8e6d-0d35fcda8ac1 0615-5619 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20000225 NDA NDA020872 NCS HealthCare of KY, Inc dba Vangard Labs FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0615-5620_cbebe8fd-aaea-4564-8e6d-0d35fcda8ac1 0615-5620 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20000225 NDA NDA020872 NCS HealthCare of KY, Inc dba Vangard Labs FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0615-5647_8da8c36d-8167-4eeb-a788-4d777bcff619 0615-5647 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20030910 ANDA ANDA076577 NCS HealthCare of KY, Inc dba Vangard Labs MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0615-5649_1cce9fcb-74f7-4f96-a546-5572b96d4d7c 0615-5649 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19830927 ANDA ANDA088391 NCS HealthCare of KY, Inc dba Vangard Labs HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 0615-6500_e897d664-2a02-4d94-ab61-93252204ccd7 0615-6500 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20010327 ANDA ANDA040411 NCS HealthCare of KY, Inc dba Vangard Labs METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 0615-6501_b7334070-8c15-4dee-ae49-8664f3d0f8fb 0615-6501 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20031219 ANDA ANDA076732 NCS HealthCare of KY, Inc dba Vangard Labs METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0615-6502_b7334070-8c15-4dee-ae49-8664f3d0f8fb 0615-6502 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20031219 ANDA ANDA076732 NCS HealthCare of KY, Inc dba Vangard Labs METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0615-6510_7d3a4bb2-fce0-43f1-88e3-e52ccf8133ec 0615-6510 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20070222 ANDA ANDA077048 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-6511_6515adfa-9620-4a60-b07b-4d106828bfe8 0615-6511 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20070222 ANDA ANDA077048 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-6512_7d3a4bb2-fce0-43f1-88e3-e52ccf8133ec 0615-6512 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20071108 ANDA ANDA077048 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-6516_bff5ebfc-cfba-4130-b971-26b98a38e026 0615-6516 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087800 NCS HealthCare of KY, Inc dba Vangard Labs PREDNISONE 1 mg/1 N 20181231 0615-6547_2da86c1e-e661-4cf7-a884-aea372cedf45 0615-6547 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110505 ANDA ANDA076704 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-6548_6da77939-92f1-4a80-97d5-a282f50c0de6 0615-6548 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20040214 ANDA ANDA075694 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-6551_0466fea6-e576-4c71-943e-9ec5038f79a2 0615-6551 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-6553_6368546a-d551-4e72-8949-8647e8416903 0615-6553 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-6554_10e4f6c8-1929-4ef3-8dfc-8026dea48ae1 0615-6554 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20041021 ANDA ANDA075694 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-6556_18862fca-d643-474b-b1af-6af180f2c45f 0615-6556 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20110722 ANDA ANDA076056 NCS HealthCare of KY, Inc dba Vangard Labs PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-6557_18862fca-d643-474b-b1af-6af180f2c45f 0615-6557 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastain Sodium TABLET ORAL 20110722 ANDA ANDA076056 NCS HealthCare of KY, Inc dba Vangard Labs PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-6558_6cbf0268-58a8-48d6-8f3b-6089a0922ed4 0615-6558 HUMAN PRESCRIPTION DRUG Sertraline Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 NCS HealthCare of KY, Inc dba Vangard Labs SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-6559_6cbf0268-58a8-48d6-8f3b-6089a0922ed4 0615-6559 HUMAN PRESCRIPTION DRUG Sertraline Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 NCS HealthCare of KY, Inc dba Vangard Labs SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-6560_6cbf0268-58a8-48d6-8f3b-6089a0922ed4 0615-6560 HUMAN PRESCRIPTION DRUG Sertraline Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 NCS HealthCare of KY, Inc dba Vangard Labs SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-6561_6368546a-d551-4e72-8949-8647e8416903 0615-6561 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-6562_fe7acbb8-148a-4932-ac78-514cc7d17729 0615-6562 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate FLUDROCORTISONE ACETATE TABLET ORAL 20020330 ANDA ANDA040431 NCS HealthCare of KY, Inc dba Vangard Labs FLUDROCORTISONE ACETATE .1 mg/1 N 20181231 0615-6563_a90a7ddb-457e-4ab4-b63e-c9f3b186f26a 0615-6563 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100630 ANDA ANDA090649 NCS HealthCare of KY, Inc dba Vangard Labs NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0615-6564_7787774c-62ab-444e-82f1-aac29452ab8e 0615-6564 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 NCS HealthCare of KY, Inc dba Vangard Labs TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0615-6566_f116f679-6ab0-4aec-9837-01b9acbffba4 0615-6566 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 NCS HealthCare of KY, Inc dba Vangard Labs VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-6567_4cf939f3-8eda-42c2-84f4-45405768fa97 0615-6567 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 NCS HealthCare of KY, Inc dba Vangard Labs VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-6568_c8f02542-79b2-4dc0-95b3-ccc60a3200c6 0615-6568 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060720 ANDA ANDA077936 NCS HealthCare of KY, Inc dba Vangard Labs MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-6569_c8f02542-79b2-4dc0-95b3-ccc60a3200c6 0615-6569 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060720 ANDA ANDA077936 NCS HealthCare of KY, Inc dba Vangard Labs MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-6570_ace11116-05af-4378-99bd-ee2f4b2aee75 0615-6570 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin mesylate TABLET ORAL 20001019 ANDA ANDA075509 NCS HealthCare of KY, Inc dba Vangard Labs DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0615-6571_ace11116-05af-4378-99bd-ee2f4b2aee75 0615-6571 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin mesylate TABLET ORAL 20001019 ANDA ANDA075509 NCS HealthCare of KY, Inc dba Vangard Labs DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0615-6572_1b5decaf-f1c9-44b7-9b2d-de3fc5b7cc99 0615-6572 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091116 ANDA ANDA078855 NCS HealthCare of KY, Inc dba Vangard Labs FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0615-6573_1b5decaf-f1c9-44b7-9b2d-de3fc5b7cc99 0615-6573 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091116 ANDA ANDA078855 NCS HealthCare of KY, Inc dba Vangard Labs FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0615-6575_9b447065-35ee-4312-9f1e-ac4b4739254b 0615-6575 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 NCS HealthCare of KY, Inc dba Vangard Labs GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0615-6576_9b447065-35ee-4312-9f1e-ac4b4739254b 0615-6576 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 NCS HealthCare of KY, Inc dba Vangard Labs GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0615-6577_789f7015-8b9c-4c80-98ea-71acdf80581c 0615-6577 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20110311 ANDA ANDA076418 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0615-6578_789f7015-8b9c-4c80-98ea-71acdf80581c 0615-6578 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20110311 ANDA ANDA076418 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0615-6579_f18ea5e0-cf1d-491d-8a03-9149e3bd2940 0615-6579 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-6580_f18ea5e0-cf1d-491d-8a03-9149e3bd2940 0615-6580 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-6581_f18ea5e0-cf1d-491d-8a03-9149e3bd2940 0615-6581 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-6582_789f7015-8b9c-4c80-98ea-71acdf80581c 0615-6582 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine TABLET ORAL 20110311 ANDA ANDA076418 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0615-6583_18a4aebe-4391-46e5-b9ed-29ac99ad269c 0615-6583 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 NCS HealthCare of KY, Inc dba Vangard Labs CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0615-6584_18a4aebe-4391-46e5-b9ed-29ac99ad269c 0615-6584 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 NCS HealthCare of KY, Inc dba Vangard Labs CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0615-6585_18a4aebe-4391-46e5-b9ed-29ac99ad269c 0615-6585 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 NCS HealthCare of KY, Inc dba Vangard Labs CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0615-6586_18a4aebe-4391-46e5-b9ed-29ac99ad269c 0615-6586 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA078227 NCS HealthCare of KY, Inc dba Vangard Labs CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0615-6587_f18ea5e0-cf1d-491d-8a03-9149e3bd2940 0615-6587 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20070816 ANDA ANDA078425 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-6588_f18ea5e0-cf1d-491d-8a03-9149e3bd2940 0615-6588 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-6589_e6754ab2-e9e5-4537-a853-a40a77b8b4b0 0615-6589 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-6590_0466fea6-e576-4c71-943e-9ec5038f79a2 0615-6590 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-6591_c811c81f-84d9-4d55-bbd4-2b30a6e5a32d 0615-6591 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20010820 ANDA ANDA040424 NCS HealthCare of KY, Inc dba Vangard Labs SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0615-6593_ec0eb04b-6d9d-4336-952b-376b19535d8e 0615-6593 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 NCS HealthCare of KY, Inc dba Vangard Labs OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-6594_91255d9d-4ef6-474b-a073-286fa6e6e5e3 0615-6594 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 NCS HealthCare of KY, Inc dba Vangard Labs OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-6595_ec0eb04b-6d9d-4336-952b-376b19535d8e 0615-6595 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 NCS HealthCare of KY, Inc dba Vangard Labs OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-6596_04f7ce27-0809-4974-9850-7d1c10dd1ad5 0615-6596 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, EXTENDED RELEASE ORAL 20030908 ANDA ANDA076467 NCS HealthCare of KY, Inc dba Vangard Labs GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0615-6597_e6754ab2-e9e5-4537-a853-a40a77b8b4b0 0615-6597 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-6598_e6754ab2-e9e5-4537-a853-a40a77b8b4b0 0615-6598 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-7505_cb1c057c-97ba-43a2-aceb-b2d096af0f6d 0615-7505 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 NCS HealthCare of KY, Inc dba Vangard Labs RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7506_cb1c057c-97ba-43a2-aceb-b2d096af0f6d 0615-7506 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 NCS HealthCare of KY, Inc dba Vangard Labs RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7507_cb1c057c-97ba-43a2-aceb-b2d096af0f6d 0615-7507 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 NCS HealthCare of KY, Inc dba Vangard Labs RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7519_093399a6-3baa-4122-9800-b5c45b2b9e11 0615-7519 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061110 ANDA ANDA076702 NCS HealthCare of KY, Inc dba Vangard Labs OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0615-7520_093399a6-3baa-4122-9800-b5c45b2b9e11 0615-7520 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061110 ANDA ANDA076644 NCS HealthCare of KY, Inc dba Vangard Labs OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0615-7521_e53fc330-b0d8-4441-8c1e-8562042d3bb4 0615-7521 HUMAN PRESCRIPTION DRUG oxybutynin chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20070510 NDA NDA020897 NCS HealthCare of KY, Inc dba Vangard Labs OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0615-7522_bf7c6a83-25d3-4f08-b4d1-60e3e444a18d 0615-7522 HUMAN OTC DRUG Cetirizine Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077946 NCS HealthCare of KY, Inc dba Vangard Labs CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0615-7523_9b447065-35ee-4312-9f1e-ac4b4739254b 0615-7523 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 NCS HealthCare of KY, Inc dba Vangard Labs GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0615-7528_3cdef1be-879c-49a7-817e-e4fdc171168c 0615-7528 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 NCS HealthCare of KY, Inc dba Vangard Labs CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0615-7530_e6754ab2-e9e5-4537-a853-a40a77b8b4b0 0615-7530 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-7531_1fbb3a5a-960b-45f5-8fe2-2cea7685617a 0615-7531 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110121 ANDA ANDA078182 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7532_1fbb3a5a-960b-45f5-8fe2-2cea7685617a 0615-7532 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110121 ANDA ANDA078182 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7533_1fbb3a5a-960b-45f5-8fe2-2cea7685617a 0615-7533 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110121 ANDA ANDA078182 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7536_5774cadb-5f61-47a2-95f8-cc73146016de 0615-7536 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET ORAL 20111027 ANDA ANDA078881 NCS HealthCare of KY, Inc dba Vangard Labs ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0615-7537_5774cadb-5f61-47a2-95f8-cc73146016de 0615-7537 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET ORAL 20111027 ANDA ANDA078881 NCS HealthCare of KY, Inc dba Vangard Labs ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0615-7538_5774cadb-5f61-47a2-95f8-cc73146016de 0615-7538 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET ORAL 20111027 ANDA ANDA078881 NCS HealthCare of KY, Inc dba Vangard Labs ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0615-7539_5774cadb-5f61-47a2-95f8-cc73146016de 0615-7539 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET ORAL 20111027 ANDA ANDA078881 NCS HealthCare of KY, Inc dba Vangard Labs ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0615-7541_0d8bcf2c-16eb-4813-90a6-99ae712f1d5c 0615-7541 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20090529 ANDA ANDA077590 NCS HealthCare of KY, Inc dba Vangard Labs GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0615-7542_0d8bcf2c-16eb-4813-90a6-99ae712f1d5c 0615-7542 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20090529 ANDA ANDA077590 NCS HealthCare of KY, Inc dba Vangard Labs GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0615-7543_0d8bcf2c-16eb-4813-90a6-99ae712f1d5c 0615-7543 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20090529 ANDA ANDA077590 NCS HealthCare of KY, Inc dba Vangard Labs GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0615-7544_6bf9a99a-7d36-4e31-b6b5-5ea65b5e942e 0615-7544 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080722 ANDA ANDA076388 NCS HealthCare of KY, Inc dba Vangard Labs LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7545_6bf9a99a-7d36-4e31-b6b5-5ea65b5e942e 0615-7545 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080722 ANDA ANDA076388 NCS HealthCare of KY, Inc dba Vangard Labs LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7546_6bf9a99a-7d36-4e31-b6b5-5ea65b5e942e 0615-7546 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080722 ANDA ANDA076388 NCS HealthCare of KY, Inc dba Vangard Labs LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7547_7a5b0e87-7214-4de4-990b-dfa0ba17348e 0615-7547 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080722 ANDA ANDA076388 NCS HealthCare of KY, Inc dba Vangard Labs LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7548_bdda5eba-bfcc-42e3-834f-860e08d72d82 0615-7548 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 NCS HealthCare of KY, Inc dba Vangard Labs FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 0615-7549_321617aa-3c20-4330-8c8c-7d964d5cab39 0615-7549 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20110117 ANDA ANDA077122 NCS HealthCare of KY, Inc dba Vangard Labs DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 0615-7550_933e9d4b-2db9-4310-a3bb-adb88d870edc 0615-7550 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7551_5432c206-0345-452f-a65c-6950d90b156b 0615-7551 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20130206 ANDA ANDA076919 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7552_5432c206-0345-452f-a65c-6950d90b156b 0615-7552 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20130206 ANDA ANDA076919 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7553_e76ae452-aa4d-4a81-b15a-6821e7473bb6 0615-7553 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078904 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7554_ed74b944-f906-4663-81b6-b5ecee869c78 0615-7554 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100208 ANDA ANDA077567 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7555_ed74b944-f906-4663-81b6-b5ecee869c78 0615-7555 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100208 ANDA ANDA077567 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7557_4cf939f3-8eda-42c2-84f4-45405768fa97 0615-7557 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 NCS HealthCare of KY, Inc dba Vangard Labs VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7558_4cf939f3-8eda-42c2-84f4-45405768fa97 0615-7558 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 NCS HealthCare of KY, Inc dba Vangard Labs VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7559_8da8c36d-8167-4eeb-a788-4d777bcff619 0615-7559 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20030910 ANDA ANDA076577 NCS HealthCare of KY, Inc dba Vangard Labs MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0615-7560_ce742cde-f442-4923-9dc8-2b33d5affa00 0615-7560 HUMAN PRESCRIPTION DRUG BUDEPRION XL XL BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061214 ANDA ANDA077284 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-7562_d8d1e518-2b20-4a4b-bd1d-f13c9f762d7a 0615-7562 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 NCS HealthCare of KY, Inc dba Vangard Labs TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0615-7563_d8d1e518-2b20-4a4b-bd1d-f13c9f762d7a 0615-7563 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 NCS HealthCare of KY, Inc dba Vangard Labs TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0615-7564_d8d1e518-2b20-4a4b-bd1d-f13c9f762d7a 0615-7564 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 NCS HealthCare of KY, Inc dba Vangard Labs TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0615-7565_d8d1e518-2b20-4a4b-bd1d-f13c9f762d7a 0615-7565 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 NCS HealthCare of KY, Inc dba Vangard Labs TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0615-7566_8da8c36d-8167-4eeb-a788-4d777bcff619 0615-7566 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20030910 ANDA ANDA076577 NCS HealthCare of KY, Inc dba Vangard Labs MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 0615-7567_5774cadb-5f61-47a2-95f8-cc73146016de 0615-7567 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET ORAL 20111027 ANDA ANDA078881 NCS HealthCare of KY, Inc dba Vangard Labs ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0615-7568_011f3ad5-2b31-4560-9aad-ae158eff396d 0615-7568 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 19960216 ANDA ANDA074069 NCS HealthCare of KY, Inc dba Vangard Labs AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 0615-7569_37c5c6bd-6df6-4f8c-b7f1-c19bb8d8243e 0615-7569 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET, FILM COATED ORAL 20100312 ANDA ANDA075893 NCS HealthCare of KY, Inc dba Vangard Labs FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7570_a6771890-b58f-4154-b584-9a145c6fd77c 0615-7570 HUMAN PRESCRIPTION DRUG Pravastatin Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076714 NCS HealthCare of KY, Inc dba Vangard Labs PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7571_a90a7ddb-457e-4ab4-b63e-c9f3b186f26a 0615-7571 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110628 ANDA ANDA090649 NCS HealthCare of KY, Inc dba Vangard Labs NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0615-7572_2be7be6a-2ca6-4388-85e4-81623d9cbc4a 0615-7572 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030109 ANDA ANDA040489 NCS HealthCare of KY, Inc dba Vangard Labs METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0615-7573_2be7be6a-2ca6-4388-85e4-81623d9cbc4a 0615-7573 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 NCS HealthCare of KY, Inc dba Vangard Labs METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0615-7574_a3a897b6-f45b-404d-a7f2-1b1811002b98 0615-7574 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride TABLET, FILM COATED ORAL 20021017 ANDA ANDA075938 NCS HealthCare of KY, Inc dba Vangard Labs PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] N 20181231 0615-7575_3e34809d-5f18-4445-b885-e1cea1c6e322 0615-7575 HUMAN PRESCRIPTION DRUG Folbic Pyridoxine and Cyanocobalamin and Folic Acid TABLET ORAL 20100219 UNAPPROVED DRUG OTHER NCS HealthCare of KY, Inc dba Vangard Labs PYRIDOXINE; CYANOCOBALAMIN; FOLIC ACID 25; 2; 2.5 mg/1; mg/1; mg/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 0615-7577_73ba838d-7be2-4fbf-b307-3ce8f6db4210 0615-7577 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20110913 ANDA ANDA075776 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0615-7581_73ba838d-7be2-4fbf-b307-3ce8f6db4210 0615-7581 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20110913 ANDA ANDA075776 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0615-7582_73ba838d-7be2-4fbf-b307-3ce8f6db4210 0615-7582 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20110913 ANDA ANDA075776 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0615-7583_193d716d-402c-400b-86c7-12ca86a280dc 0615-7583 HUMAN PRESCRIPTION DRUG propylthiouracil propylthiouracil TABLET ORAL 19730109 ANDA ANDA080172 NCS HealthCare of KY, Inc dba Vangard Labs PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 0615-7584_81519143-1c49-47d7-9924-51e22063ae6a 0615-7584 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19830210 ANDA ANDA087946 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE DINITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-7585_9edae1d0-63c3-4a88-9902-d07722f1e930 0615-7585 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20090908 ANDA ANDA077463 NCS HealthCare of KY, Inc dba Vangard Labs NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0615-7586_9edae1d0-63c3-4a88-9902-d07722f1e930 0615-7586 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20090908 ANDA ANDA077463 NCS HealthCare of KY, Inc dba Vangard Labs NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0615-7590_b9ca1eb1-3d54-46aa-b24a-33fa7bad687d 0615-7590 HUMAN OTC DRUG Acetaminophen Extended Release Acetaminophen TABLET ORAL 20000225 ANDA ANDA075077 NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN 650 mg/1 N 20181231 0615-7591_bbe3424d-45e4-44f9-80a8-730e08049483 0615-7591 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 NCS HealthCare of KY, Inc dba Vangard Labs CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0615-7593_4fe14aa2-eafb-4a3f-b04c-c0d9cb90b5e4 0615-7593 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 19881114 ANDA ANDA071826 NCS HealthCare of KY, Inc dba Vangard Labs MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 0615-7597_9a8d5c03-8596-491b-8cc0-89b7acfdfca5 0615-7597 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100101 ANDA ANDA077724 NCS HealthCare of KY, Inc dba Vangard Labs PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0615-7604_21e68075-8d82-4bd8-be9c-05ef2647dc20 0615-7604 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 NCS HealthCare of KY, Inc dba Vangard Labs LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0615-7605_21e68075-8d82-4bd8-be9c-05ef2647dc20 0615-7605 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 NCS HealthCare of KY, Inc dba Vangard Labs LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0615-7606_21e68075-8d82-4bd8-be9c-05ef2647dc20 0615-7606 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 NCS HealthCare of KY, Inc dba Vangard Labs LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0615-7607_484d179f-c1d7-4b8e-a3df-d22ece88e497 0615-7607 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100429 ANDA ANDA090408 NCS HealthCare of KY, Inc dba Vangard Labs TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0615-7613_e897d664-2a02-4d94-ab61-93252204ccd7 0615-7613 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20010327 ANDA ANDA040411 NCS HealthCare of KY, Inc dba Vangard Labs METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 0615-7618_4ca4589b-28bd-4f8d-b1e8-3a4ba4323253 0615-7618 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070995 NCS HealthCare of KY, Inc dba Vangard Labs VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0615-7619_4ca4589b-28bd-4f8d-b1e8-3a4ba4323253 0615-7619 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 NCS HealthCare of KY, Inc dba Vangard Labs VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0615-7620_f591294f-281e-4211-babd-e62a4bc1b2fe 0615-7620 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 NCS HealthCare of KY, Inc dba Vangard Labs VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7621_f591294f-281e-4211-babd-e62a4bc1b2fe 0615-7621 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 NCS HealthCare of KY, Inc dba Vangard Labs VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7622_f591294f-281e-4211-babd-e62a4bc1b2fe 0615-7622 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 NCS HealthCare of KY, Inc dba Vangard Labs VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7623_012959a5-397a-4d92-8758-656327a64ed6 0615-7623 HUMAN PRESCRIPTION DRUG donepezil hydrochloride DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 19961126 NDA NDA020690 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0615-7624_012959a5-397a-4d92-8758-656327a64ed6 0615-7624 HUMAN PRESCRIPTION DRUG donepezil hydrochloride DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 19961126 NDA NDA020690 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0615-7625_ae147621-61cb-4303-b340-23500a18f0f5 0615-7625 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7626_68c525af-34dc-4bc3-b392-faa98017e24f 0615-7626 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0615-7627_68c525af-34dc-4bc3-b392-faa98017e24f 0615-7627 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0615-7628_68c525af-34dc-4bc3-b392-faa98017e24f 0615-7628 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0615-7629_f044d90f-9012-488d-9f9d-b9fe779d4f4c 0615-7629 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20120123 ANDA ANDA090970 NCS HealthCare of KY, Inc dba Vangard Labs PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 0615-7630_37f76c65-fba3-458e-9029-b48ee61a11c8 0615-7630 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 NCS HealthCare of KY, Inc dba Vangard Labs NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-7631_bbeedc69-56c3-44e2-b594-0c05d1f08942 0615-7631 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-7632_bbeedc69-56c3-44e2-b594-0c05d1f08942 0615-7632 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-7633_68145eef-7e8e-4817-bab3-8ca8d579ce85 0615-7633 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 0615-7634_68145eef-7e8e-4817-bab3-8ca8d579ce85 0615-7634 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 0615-7635_68145eef-7e8e-4817-bab3-8ca8d579ce85 0615-7635 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 0615-7636_d2c9e88a-df18-4ba7-be45-13cf14b0d6c9 0615-7636 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20100701 ANDA ANDA076447 NCS HealthCare of KY, Inc dba Vangard Labs FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0615-7638_406263e7-eb74-4746-a864-cdd225b38748 0615-7638 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7639_35e2befc-faf9-486b-97d3-71f98e7e6982 0615-7639 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET, FILM COATED ORAL 20070419 ANDA ANDA078402 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7640_35e2befc-faf9-486b-97d3-71f98e7e6982 0615-7640 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET, FILM COATED ORAL 20070419 ANDA ANDA078402 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7641_35e2befc-faf9-486b-97d3-71f98e7e6982 0615-7641 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET, FILM COATED ORAL 20070419 ANDA ANDA078402 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7642_35e2befc-faf9-486b-97d3-71f98e7e6982 0615-7642 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET, FILM COATED ORAL 20070419 ANDA ANDA078402 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7643_35e2befc-faf9-486b-97d3-71f98e7e6982 0615-7643 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET, FILM COATED ORAL 20070419 ANDA ANDA078402 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7644_35e2befc-faf9-486b-97d3-71f98e7e6982 0615-7644 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET, FILM COATED ORAL 20070419 ANDA ANDA078402 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7645_37f76c65-fba3-458e-9029-b48ee61a11c8 0615-7645 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 NCS HealthCare of KY, Inc dba Vangard Labs NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-7646_d2518f4d-eafc-4107-ba76-5453bb220927 0615-7646 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20101025 NDA AUTHORIZED GENERIC NDA018238 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0615-7653_7879f700-695d-4ab5-b3b3-dfbb349853a7 0615-7653 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0615-7654_7879f700-695d-4ab5-b3b3-dfbb349853a7 0615-7654 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0615-7655_c8974e25-2da4-4113-b7ef-4707587488c3 0615-7655 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin CAPSULE ORAL 20110506 ANDA ANDA074967 NCS HealthCare of KY, Inc dba Vangard Labs NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 0615-7656_0e08d748-79fa-40fd-baea-e3d219a82c35 0615-7656 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20090102 OTC MONOGRAPH FINAL part341 NCS HealthCare of KY, Inc dba Vangard Labs DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0615-7657_9060e29c-a706-4d3b-8f12-cfa811d7350c 0615-7657 HUMAN OTC DRUG DIPHENDYDRAMINE HYDROCHLORIDE DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20090102 OTC MONOGRAPH FINAL part336 NCS HealthCare of KY, Inc dba Vangard Labs DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 0615-7659_cd644ad1-e040-47b2-962c-a7c00803498c 0615-7659 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100719 ANDA ANDA077455 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-7660_cd644ad1-e040-47b2-962c-a7c00803498c 0615-7660 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080312 ANDA ANDA077455 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-7661_1b4b6eee-b98c-4ea1-809c-25b65ea83449 0615-7661 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20100727 ANDA ANDA075978 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0615-7662_1b4b6eee-b98c-4ea1-809c-25b65ea83449 0615-7662 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20100727 ANDA ANDA075978 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0615-7663_1b4b6eee-b98c-4ea1-809c-25b65ea83449 0615-7663 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20100727 ANDA ANDA075978 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0615-7666_e76bd28e-31d6-4de4-bec4-4f5049c5a5da 0615-7666 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20100122 ANDA ANDA075189 NCS HealthCare of KY, Inc dba Vangard Labs NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-7667_54a6ebca-d297-4ebe-b9b0-0c8d2b446a77 0615-7667 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20100122 ANDA ANDA075189 NCS HealthCare of KY, Inc dba Vangard Labs NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-7668_757a7821-47f3-469a-b72d-40f3c0fb84c2 0615-7668 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 NCS HealthCare of KY, Inc dba Vangard Labs PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-7670_f1f82ae5-53d2-4cb5-a4bc-682d66082524 0615-7670 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 NCS HealthCare of KY, Inc dba Vangard Labs OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7671_71e74828-a499-44ae-96ad-a4500460a7a6 0615-7671 HUMAN PRESCRIPTION DRUG olanzapine olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 NCS HealthCare of KY, Inc dba Vangard Labs OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7672_71e74828-a499-44ae-96ad-a4500460a7a6 0615-7672 HUMAN PRESCRIPTION DRUG olanzapine olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 NCS HealthCare of KY, Inc dba Vangard Labs OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7673_f8640667-468a-4ad3-892b-9ccd40f6a591 0615-7673 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076133 NCS HealthCare of KY, Inc dba Vangard Labs OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7674_c2f40cba-8a84-475a-a74b-12e722d8e9ae 0615-7674 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20111101 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7675_a56bcb74-de50-4c37-9c79-dd33abe04687 0615-7675 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 19961212 ANDA ANDA040103 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0615-7676_a56bcb74-de50-4c37-9c79-dd33abe04687 0615-7676 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 19961212 ANDA ANDA040103 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0615-7677_a56bcb74-de50-4c37-9c79-dd33abe04687 0615-7677 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 19961212 ANDA ANDA040103 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0615-7678_5477b3da-5999-430b-815b-394cfd786d19 0615-7678 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070904 ANDA ANDA040597 NCS HealthCare of KY, Inc dba Vangard Labs BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 0615-7679_495dfca9-c3e6-4efe-a30a-e99906e735a2 0615-7679 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7683_19dd962f-55d9-47a7-8c00-e91bf0d66f5c 0615-7683 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084113 NCS HealthCare of KY, Inc dba Vangard Labs CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-7684_5866e047-f439-4133-9216-87ac2db690ae 0615-7684 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078858 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7685_d7461921-fd95-4d44-80cb-b966dbf5e2eb 0615-7685 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7686_130580ab-9628-452b-b05f-2bd1781b2097 0615-7686 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20110101 ANDA ANDA074787 NCS HealthCare of KY, Inc dba Vangard Labs LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-7687_130580ab-9628-452b-b05f-2bd1781b2097 0615-7687 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20110101 ANDA ANDA074787 NCS HealthCare of KY, Inc dba Vangard Labs LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-7688_130580ab-9628-452b-b05f-2bd1781b2097 0615-7688 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20110101 ANDA ANDA074787 NCS HealthCare of KY, Inc dba Vangard Labs LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-7689_91a26576-340e-4699-856f-42510bcb2b1d 0615-7689 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 0615-7690_495dfca9-c3e6-4efe-a30a-e99906e735a2 0615-7690 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NCS HealthCare of KY, Inc dba Vangard Labs LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7691_32150874-4c83-4ce9-a4ad-f26ce6549e42 0615-7691 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20100118 ANDA ANDA076698 NCS HealthCare of KY, Inc dba Vangard Labs METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0615-7692_32150874-4c83-4ce9-a4ad-f26ce6549e42 0615-7692 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20100118 ANDA ANDA076698 NCS HealthCare of KY, Inc dba Vangard Labs METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 0615-7693_eede9a6a-6d1b-451c-8d84-eb49b01aae36 0615-7693 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070033 NCS HealthCare of KY, Inc dba Vangard Labs METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0615-7694_a151ff6f-6153-47d1-bb81-e4756c7eb80f 0615-7694 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20101025 NDA AUTHORIZED GENERIC NDA018238 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0615-7695_cb572295-e78c-40b8-8a9b-d5d1b36e7b07 0615-7695 HUMAN OTC DRUG Fexofenodine Hydrochloride Fexofenadine TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 NCS HealthCare of KY, Inc dba Vangard Labs FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 0615-7696_c556a3da-dd66-4f9c-9514-98c68e2d6e75 0615-7696 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 NCS HealthCare of KY, Inc dba Vangard Labs FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 0615-7698_32cbd5c0-b8bc-4dc1-9d78-3bccba3f65d9 0615-7698 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20111118 ANDA ANDA072801 NCS HealthCare of KY, Inc dba Vangard Labs METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0615-7699_71e74828-a499-44ae-96ad-a4500460a7a6 0615-7699 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 NCS HealthCare of KY, Inc dba Vangard Labs OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7703_31523ae2-b4b1-4691-bb0c-f581782a33b2 0615-7703 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 NCS HealthCare of KY, Inc dba Vangard Labs ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7704_169bb12d-2533-41f1-a1e0-891b1c5bcdf1 0615-7704 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7705_169bb12d-2533-41f1-a1e0-891b1c5bcdf1 0615-7705 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7706_169bb12d-2533-41f1-a1e0-891b1c5bcdf1 0615-7706 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7707_169bb12d-2533-41f1-a1e0-891b1c5bcdf1 0615-7707 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20120614 ANDA ANDA077691 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7709_06ca0dcb-5a5c-4104-b38f-b964fbcca08c 0615-7709 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110718 ANDA ANDA074201 NCS HealthCare of KY, Inc dba Vangard Labs NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-7712_3e214e7d-8263-4eb7-8b2a-a8937e80fb24 0615-7712 HUMAN OTC DRUG Guaifenesin Extended Release Extended Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20120328 ANDA ANDA078912 NCS HealthCare of KY, Inc dba Vangard Labs GUAIFENESIN 600 mg/1 N 20181231 0615-7713_de2d67e7-bf27-4764-bbc6-aef1db4f7ea2 0615-7713 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20120323 ANDA ANDA077027 NCS HealthCare of KY, Inc dba Vangard Labs CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0615-7714_91a26576-340e-4699-856f-42510bcb2b1d 0615-7714 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120423 ANDA ANDA075022 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 0615-7716_84fd20f2-c938-45d9-8550-20c350d3f631 0615-7716 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20120626 ANDA ANDA077027 NCS HealthCare of KY, Inc dba Vangard Labs CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0615-7717_19dd962f-55d9-47a7-8c00-e91bf0d66f5c 0615-7717 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084114 NCS HealthCare of KY, Inc dba Vangard Labs CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-7718_91a26576-340e-4699-856f-42510bcb2b1d 0615-7718 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 NCS HealthCare of KY, Inc dba Vangard Labs BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 0615-7719_ce3c1707-95ff-4004-961e-95e9bba43b5f 0615-7719 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA076999 NCS HealthCare of KY, Inc dba Vangard Labs CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 0615-7720_2b4cd7d7-bdf7-4e7d-aeb5-d6d6fe04d8cc 0615-7720 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 NCS HealthCare of KY, Inc dba Vangard Labs ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7721_2b4cd7d7-bdf7-4e7d-aeb5-d6d6fe04d8cc 0615-7721 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 NCS HealthCare of KY, Inc dba Vangard Labs ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7722_2b4cd7d7-bdf7-4e7d-aeb5-d6d6fe04d8cc 0615-7722 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 NCS HealthCare of KY, Inc dba Vangard Labs ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7724_7fe8a652-3689-4f34-857c-fedb58123b03 0615-7724 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 NCS HealthCare of KY, Inc dba Vangard Labs QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7725_9259cf91-0894-4e2b-8565-aa808fbd3824 0615-7725 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 NCS HealthCare of KY, Inc dba Vangard Labs QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7726_9259cf91-0894-4e2b-8565-aa808fbd3824 0615-7726 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 NCS HealthCare of KY, Inc dba Vangard Labs QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7727_9259cf91-0894-4e2b-8565-aa808fbd3824 0615-7727 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 NCS HealthCare of KY, Inc dba Vangard Labs QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7728_7fe8a652-3689-4f34-857c-fedb58123b03 0615-7728 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 NCS HealthCare of KY, Inc dba Vangard Labs QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7729_6a0b6ef4-ba1d-4f1a-8620-94ac85e48179 0615-7729 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 NCS HealthCare of KY, Inc dba Vangard Labs DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0615-7730_6a0b6ef4-ba1d-4f1a-8620-94ac85e48179 0615-7730 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 NCS HealthCare of KY, Inc dba Vangard Labs DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0615-7737_19dd962f-55d9-47a7-8c00-e91bf0d66f5c 0615-7737 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084112 NCS HealthCare of KY, Inc dba Vangard Labs CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0615-7738_4bd1672f-54df-4a23-a7cd-dd63d302abdc 0615-7738 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 19781201 ANDA ANDA084903 NCS HealthCare of KY, Inc dba Vangard Labs PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7740_1978b2f3-3a16-42fa-9837-ab786ea267b1 0615-7740 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20080929 ANDA ANDA077793 NCS HealthCare of KY, Inc dba Vangard Labs PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7747_84fd20f2-c938-45d9-8550-20c350d3f631 0615-7747 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20120323 ANDA ANDA077027 NCS HealthCare of KY, Inc dba Vangard Labs CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0615-7748_508c39f3-66a8-4db2-b1ec-87533ab2ca03 0615-7748 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA078605 NCS HealthCare of KY, Inc dba Vangard Labs MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0615-7749_fc028060-53ef-4b79-8767-8a446e53a066 0615-7749 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-7750_fc028060-53ef-4b79-8767-8a446e53a066 0615-7750 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-7751_fc028060-53ef-4b79-8767-8a446e53a066 0615-7751 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-7752_e3f3de04-1c4f-4af6-836d-06cbebc6b63c 0615-7752 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19851017 ANDA ANDA070581 NCS HealthCare of KY, Inc dba Vangard Labs METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0615-7753_fc028060-53ef-4b79-8767-8a446e53a066 0615-7753 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-7754_57bc249e-bc84-43d0-a294-4fd8f55f2c2d 0615-7754 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 NCS HealthCare of KY, Inc dba Vangard Labs DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0615-7755_1b09fce6-6835-48ad-a2d3-aae80b549579 0615-7755 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 NCS HealthCare of KY, Inc dba Vangard Labs DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0615-7756_f6d7be3e-a108-4617-8864-352d233e85b0 0615-7756 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-7757_f6d7be3e-a108-4617-8864-352d233e85b0 0615-7757 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-7761_767c21f7-8cfc-42fa-8426-8baa18752ab1 0615-7761 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071972 NCS HealthCare of KY, Inc dba Vangard Labs PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-7762_3f9d516c-c418-46d6-a229-550abfc9efec 0615-7762 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7764_72ca248c-2b35-4319-b081-855f3ce1b5d3 0615-7764 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin TABLET, CHEWABLE ORAL 20121226 ANDA ANDA200691 NCS HealthCare of KY, Inc dba Vangard Labs PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0615-7767_f8254d44-b47a-4e83-bbb9-c99f6fc3ce52 0615-7767 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200270 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-7768_f8254d44-b47a-4e83-bbb9-c99f6fc3ce52 0615-7768 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200495 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-7769_f2542d36-8358-4746-b9ae-9c193aa65d09 0615-7769 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 NCS HealthCare of KY, Inc dba Vangard Labs ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7770_f2542d36-8358-4746-b9ae-9c193aa65d09 0615-7770 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 NCS HealthCare of KY, Inc dba Vangard Labs ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7771_f2542d36-8358-4746-b9ae-9c193aa65d09 0615-7771 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 NCS HealthCare of KY, Inc dba Vangard Labs ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7772_438c5c78-d15c-4b74-abbc-7485aba00c69 0615-7772 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA202357 NCS HealthCare of KY, Inc dba Vangard Labs ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7773_7769018d-0184-4e86-b09b-e7ae38addfe5 0615-7773 HUMAN OTC DRUG SENEXON-S docusate sodium-sennosides tablet TABLET, COATED ORAL 20060209 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs SENNOSIDES A AND B; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 0615-7774_487b2c2b-c0e3-4857-8e5f-fa030201ca27 0615-7774 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020702 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7775_487b2c2b-c0e3-4857-8e5f-fa030201ca27 0615-7775 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7776_487b2c2b-c0e3-4857-8e5f-fa030201ca27 0615-7776 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7777_487b2c2b-c0e3-4857-8e5f-fa030201ca27 0615-7777 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7778_4be2e25b-e1f2-4a4c-8914-72981474b736 0615-7778 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7779_487b2c2b-c0e3-4857-8e5f-fa030201ca27 0615-7779 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7792_4292ed78-29d8-4b2c-8e5c-5e29d8017077 0615-7792 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19900930 ANDA ANDA088628 NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0615-7793_b93e42d9-bd05-4dcb-9294-1a98e8c09f60 0615-7793 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19950103 ANDA ANDA074342 NCS HealthCare of KY, Inc dba Vangard Labs ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-7794_0195815a-f289-40cd-b48a-baaede030dc0 0615-7794 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19950103 ANDA ANDA074342 NCS HealthCare of KY, Inc dba Vangard Labs ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-7795_b93e42d9-bd05-4dcb-9294-1a98e8c09f60 0615-7795 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19950103 ANDA ANDA074342 NCS HealthCare of KY, Inc dba Vangard Labs ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-7796_3eff95cc-0d53-4ac1-8702-82f253a49119 0615-7796 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 NCS HealthCare of KY, Inc dba Vangard Labs CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-7800_ee5d29de-6881-4840-a05e-581716b7ed1f 0615-7800 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071322 NCS HealthCare of KY, Inc dba Vangard Labs DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-7801_2e43a2b5-8ec9-4b4c-839f-9958899e33a0 0615-7801 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 NCS HealthCare of KY, Inc dba Vangard Labs DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 0615-7805_0f587f74-2bea-44ca-ad8f-c09fe1ded306 0615-7805 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061227 ANDA ANDA077657 NCS HealthCare of KY, Inc dba Vangard Labs LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-7808_56ed9aa6-1170-468e-b80e-7b5a46d7601c 0615-7808 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071427 NCS HealthCare of KY, Inc dba Vangard Labs TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-7809_56ed9aa6-1170-468e-b80e-7b5a46d7601c 0615-7809 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071428 NCS HealthCare of KY, Inc dba Vangard Labs TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-7810_b33f3503-1b4c-4fbb-8b63-04971b39b554 0615-7810 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride tramadol hydrochloride TABLET, FILM COATED ORAL 20020621 ANDA ANDA075986 NCS HealthCare of KY, Inc dba Vangard Labs TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 0615-7814_cef1cb71-78ce-424e-a1e4-82d60474a126 0615-7814 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 NCS HealthCare of KY, Inc dba Vangard Labs FOLIC ACID 1 mg/1 N 20181231 0615-7823_55c9cdcc-cf52-4b8b-a1af-9351c7c2e8ab 0615-7823 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-7824_55c9cdcc-cf52-4b8b-a1af-9351c7c2e8ab 0615-7824 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-7825_35a8ee96-5a0f-4455-baec-840e545a75ab 0615-7825 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-7830_7353a8af-3bcd-4ecb-9b66-22521aa6a29d 0615-7830 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7831_7353a8af-3bcd-4ecb-9b66-22521aa6a29d 0615-7831 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7832_7353a8af-3bcd-4ecb-9b66-22521aa6a29d 0615-7832 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7839_c3586460-82ea-406c-9cf8-326d3147ad04 0615-7839 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7840_0f5cd26d-1274-444a-bdfd-eb8f7476d1f1 0615-7840 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 20090908 ANDA ANDA073229 NCS HealthCare of KY, Inc dba Vangard Labs VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7842_fa9aef3f-7b23-4e91-9328-3ddf51ed4f35 0615-7842 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0615-7843_fa9aef3f-7b23-4e91-9328-3ddf51ed4f35 0615-7843 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET ORAL 20110528 ANDA ANDA090686 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0615-7844_c3586460-82ea-406c-9cf8-326d3147ad04 0615-7844 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7845_c3586460-82ea-406c-9cf8-326d3147ad04 0615-7845 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7846_9259cf91-0894-4e2b-8565-aa808fbd3824 0615-7846 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140312 ANDA ANDA077745 NCS HealthCare of KY, Inc dba Vangard Labs QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7847_64e767dc-f4a7-42c7-83f3-4be9aef2dca9 0615-7847 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0615-7848_a00f2937-f508-4267-9614-dd74b06e139b 0615-7848 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7849_a02d04f2-7ff7-43cc-b949-17a055c6861e 0615-7849 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7850_a02d04f2-7ff7-43cc-b949-17a055c6861e 0615-7850 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7860_ff991d00-b2c8-4957-afdb-e4ede4d35f1e 0615-7860 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20140627 ANDA ANDA087479 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0615-7861_3feec88c-4dcc-44a9-ab04-393b53edd92b 0615-7861 HUMAN PRESCRIPTION DRUG KLOR-CON M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20140901 ANDA ANDA074726 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0615-7862_3feec88c-4dcc-44a9-ab04-393b53edd92b 0615-7862 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20140901 ANDA ANDA074726 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0615-7863_ba2b41ea-c414-4551-bc72-6bed930ef947 0615-7863 HUMAN OTC DRUG aspirin aspirin TABLET ORAL 20100716 OTC MONOGRAPH FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ASPIRIN 81 mg/1 N 20181231 0615-7864_34555b87-bc4c-43ef-99b6-661a438e04ca 0615-7864 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-7865_34555b87-bc4c-43ef-99b6-661a438e04ca 0615-7865 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-7867_dfb286b1-ce07-47e4-b62d-04e97d056d42 0615-7867 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140821 ANDA ANDA204662 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0615-7868_01ed1c4e-2e41-416b-8864-827f0680b760 0615-7868 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20140428 ANDA ANDA076397 NCS HealthCare of KY, Inc dba Vangard Labs PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7869_01ed1c4e-2e41-416b-8864-827f0680b760 0615-7869 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20140428 ANDA ANDA076397 NCS HealthCare of KY, Inc dba Vangard Labs PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7870_582b2e37-842e-47ac-8911-c527b7ce4270 0615-7870 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 NCS HealthCare of KY, Inc dba Vangard Labs MIRTAZAPINE 7.5 mg/1 N 20181231 0615-7885_396ff0a6-7950-4371-941e-8448e0033ab3 0615-7885 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060719 ANDA ANDA077921 NCS HealthCare of KY, Inc dba Vangard Labs MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-7886_396ff0a6-7950-4371-941e-8448e0033ab3 0615-7886 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 NCS HealthCare of KY, Inc dba Vangard Labs MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-7887_9c9dcbcb-0310-4533-8208-d2322ddee34f 0615-7887 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 NCS HealthCare of KY, Inc dba Vangard Labs BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 0615-7888_2aa92b1f-aaaa-421b-89d2-7391191d307e 0615-7888 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 NCS HealthCare of KY, Inc dba Vangard Labs SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 0615-7892_ad07b458-6559-4469-b1e1-34fe79f227d9 0615-7892 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 NCS HealthCare of KY, Inc dba Vangard Labs NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-7894_33f15a34-eeda-412e-b53a-a184922e0676 0615-7894 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 NCS HealthCare of KY, Inc dba Vangard Labs DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7895_33f15a34-eeda-412e-b53a-a184922e0676 0615-7895 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 NCS HealthCare of KY, Inc dba Vangard Labs DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7901_92f818aa-8da3-46bf-b6c3-224a40a4d5ac 0615-7901 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE ORAL 20150228 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE SODIUM 100 mg/1 N 20181231 0615-7902_df3075a4-cf74-45f7-8564-34adf69cff7a 0615-7902 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880107 ANDA ANDA086223 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-7903_df3075a4-cf74-45f7-8564-34adf69cff7a 0615-7903 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880407 ANDA ANDA089367 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-7904_0992df8c-3270-4e85-8dec-011d525f4dcf 0615-7904 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040322 ANDA ANDA075932 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-7907_1091af5d-b6b0-4de5-a7dc-a63dc2aba17b 0615-7907 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000822 ANDA ANDA075480 NCS HealthCare of KY, Inc dba Vangard Labs ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0615-7908_1091af5d-b6b0-4de5-a7dc-a63dc2aba17b 0615-7908 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000822 ANDA ANDA075480 NCS HealthCare of KY, Inc dba Vangard Labs ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0615-7909_1091af5d-b6b0-4de5-a7dc-a63dc2aba17b 0615-7909 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000822 ANDA ANDA075480 NCS HealthCare of KY, Inc dba Vangard Labs ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0615-7912_fb7feddf-f05f-4544-9960-e9f70ee199c6 0615-7912 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20071121 ANDA ANDA040855 NCS HealthCare of KY, Inc dba Vangard Labs BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0615-7915_986d7395-1848-4336-ad31-66ba3045ed99 0615-7915 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 NCS HealthCare of KY, Inc dba Vangard Labs BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0615-7916_c0d42cf9-78d2-40c6-ab6f-59ce0dd2f695 0615-7916 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071221 ANDA ANDA077056 NCS HealthCare of KY, Inc dba Vangard Labs PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 0615-7917_bf385b2f-0da6-4145-a1c0-5d16c0fe91a8 0615-7917 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20150521 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7918_bf385b2f-0da6-4145-a1c0-5d16c0fe91a8 0615-7918 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150523 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7923_ec95d7f0-2320-4ac7-b27a-5be5d65e7f39 0615-7923 HUMAN OTC DRUG SENNA SENNA TABLET, COATED ORAL 20150609 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs SENNOSIDES A AND B 8.6 mg/1 N 20181231 0615-7925_41f4f2f6-0158-4b16-bc4f-c35f79f951db 0615-7925 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE SODIUM 250 mg/1 N 20181231 0615-7932_91e54b09-04f2-46ae-92f3-949498ef91c1 0615-7932 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19851017 ANDA ANDA070581 NCS HealthCare of KY, Inc dba Vangard Labs METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0615-7933_b9dbd4f9-1044-4c84-a422-c3b46e8b210a 0615-7933 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20030128 ANDA ANDA075757 NCS HealthCare of KY, Inc dba Vangard Labs OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0615-7934_bf385b2f-0da6-4145-a1c0-5d16c0fe91a8 0615-7934 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20150609 ANDA ANDA075994 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7935_1e632ed8-c688-4617-bd91-298fc030b2c1 0615-7935 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20140114 NDA AUTHORIZED GENERIC NDA020405 NCS HealthCare of KY, Inc dba Vangard Labs DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0615-7936_e1f9f4bc-adee-4f7b-aafe-226d4a3b5971 0615-7936 HUMAN PRESCRIPTION DRUG Primidone primidone TABLET ORAL 20050224 ANDA ANDA040586 NCS HealthCare of KY, Inc dba Vangard Labs PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7937_c693cbff-6147-4273-9304-3de9002bae6d 0615-7937 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 NCS HealthCare of KY, Inc dba Vangard Labs FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0615-7938_8ba3abd1-abc2-4e13-9ac7-5e1fbbc87bcd 0615-7938 HUMAN PRESCRIPTION DRUG Fuosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 NCS HealthCare of KY, Inc dba Vangard Labs FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0615-7939_b1704f51-8080-4f2d-8ef8-1e01464b783c 0615-7939 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070926 ANDA ANDA077073 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0615-7940_46aa64c0-e30f-408a-bcdd-380f7f444d1e 0615-7940 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0615-7941_b1704f51-8080-4f2d-8ef8-1e01464b783c 0615-7941 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0615-7942_b1704f51-8080-4f2d-8ef8-1e01464b783c 0615-7942 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070926 ANDA ANDA077073 NCS HealthCare of KY, Inc dba Vangard Labs AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0615-7944_ccdabefe-92c2-48c1-b690-2f721af7612c 0615-7944 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 NCS HealthCare of KY, Inc dba Vangard Labs CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0615-7945_ccdabefe-92c2-48c1-b690-2f721af7612c 0615-7945 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 NCS HealthCare of KY, Inc dba Vangard Labs CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0615-7946_ccdabefe-92c2-48c1-b690-2f721af7612c 0615-7946 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 NCS HealthCare of KY, Inc dba Vangard Labs CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0615-7947_2772d193-ef73-4a10-8172-536c3325d100 0615-7947 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 NCS HealthCare of KY, Inc dba Vangard Labs CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0615-7948_2772d193-ef73-4a10-8172-536c3325d100 0615-7948 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 NCS HealthCare of KY, Inc dba Vangard Labs CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0615-7949_383dea35-5e99-42c4-a684-e14c82e2fefb 0615-7949 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7950_383dea35-5e99-42c4-a684-e14c82e2fefb 0615-7950 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7951_e5ccb368-7db5-4289-8a07-c870330a365e 0615-7951 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA201146 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0615-7952_e5ccb368-7db5-4289-8a07-c870330a365e 0615-7952 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA201146 NCS HealthCare of KY, Inc dba Vangard Labs DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0615-7953_737f0a7d-6277-4d9b-94e1-1be724f779d6 0615-7953 HUMAN PRESCRIPTION DRUG Escitalopram Escitslopram TABLET ORAL 20120910 ANDA ANDA078169 NCS HealthCare of KY, Inc dba Vangard Labs ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7954_737f0a7d-6277-4d9b-94e1-1be724f779d6 0615-7954 HUMAN PRESCRIPTION DRUG Escitalopram Escitslopram TABLET ORAL 20120910 ANDA ANDA078169 NCS HealthCare of KY, Inc dba Vangard Labs ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7955_737f0a7d-6277-4d9b-94e1-1be724f779d6 0615-7955 HUMAN PRESCRIPTION DRUG Escitalopram Escitslopram TABLET ORAL 20120910 ANDA ANDA078169 NCS HealthCare of KY, Inc dba Vangard Labs ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7956_383dea35-5e99-42c4-a684-e14c82e2fefb 0615-7956 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 NCS HealthCare of KY, Inc dba Vangard Labs DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7957_8ba3abd1-abc2-4e13-9ac7-5e1fbbc87bcd 0615-7957 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19910313 ANDA ANDA070086 NCS HealthCare of KY, Inc dba Vangard Labs FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0615-7958_40f12a79-ba2a-4548-96bd-6b80bcb2839c 0615-7958 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 NCS HealthCare of KY, Inc dba Vangard Labs LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0615-7959_40f12a79-ba2a-4548-96bd-6b80bcb2839c 0615-7959 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 NCS HealthCare of KY, Inc dba Vangard Labs LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0615-7960_40f12a79-ba2a-4548-96bd-6b80bcb2839c 0615-7960 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 NCS HealthCare of KY, Inc dba Vangard Labs LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0615-7961_a876f9a1-9bc6-4417-b17d-42780b05b084 0615-7961 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7962_95f621eb-2e7f-4c67-87b8-d29e2cd494df 0615-7962 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7963_a876f9a1-9bc6-4417-b17d-42780b05b084 0615-7963 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7964_c6e145d0-9521-431c-a3dc-ae85ca68cf17 0615-7964 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 NCS HealthCare of KY, Inc dba Vangard Labs LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7966_46d6d8f9-0cfc-43ee-a635-fcfac319715b 0615-7966 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20130915 ANDA ANDA202554 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7968_cbcaf310-2931-49e6-a918-be96139ea01b 0615-7968 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 NCS HealthCare of KY, Inc dba Vangard Labs GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0615-7969_cbcaf310-2931-49e6-a918-be96139ea01b 0615-7969 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 NCS HealthCare of KY, Inc dba Vangard Labs GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0615-7973_f23a6b50-cd2b-4b63-9279-c9f1154bb768 0615-7973 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 NCS HealthCare of KY, Inc dba Vangard Labs HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 0615-7974_103cb1a3-4972-4866-a1e5-1d18840315c5 0615-7974 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0615-7975_c6e145d0-9521-431c-a3dc-ae85ca68cf17 0615-7975 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 NCS HealthCare of KY, Inc dba Vangard Labs LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0615-7976_6f880a8a-39e1-4cad-b171-feeae8f924bb 0615-7976 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120109 ANDA ANDA090515 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7977_843c8de1-f7ad-4f5f-9bd1-a75a48da12fe 0615-7977 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120109 ANDA ANDA090515 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7978_6f880a8a-39e1-4cad-b171-feeae8f924bb 0615-7978 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120109 ANDA ANDA090515 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7979_af166088-3fb3-4ce3-80fd-a578d108107f 0615-7979 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA090025 NCS HealthCare of KY, Inc dba Vangard Labs LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-7980_46d6d8f9-0cfc-43ee-a635-fcfac319715b 0615-7980 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20130915 ANDA ANDA202554 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7981_46d6d8f9-0cfc-43ee-a635-fcfac319715b 0615-7981 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20130915 ANDA ANDA202554 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-7982_1a29ed1e-73ae-4cf3-8b42-de81a2d922b2 0615-7982 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0615-7983_e36d02c8-d5a3-4067-b85e-3a25e97972bf 0615-7983 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20120803 ANDA ANDA090655 NCS HealthCare of KY, Inc dba Vangard Labs MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0615-7985_ddcfbb53-7e1d-4b49-b09a-c93d1977dc56 0615-7985 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 NCS HealthCare of KY, Inc dba Vangard Labs PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7986_087b49e9-6968-4472-8a97-fa2d71f8a001 0615-7986 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 NCS HealthCare of KY, Inc dba Vangard Labs QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7987_087b49e9-6968-4472-8a97-fa2d71f8a001 0615-7987 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 NCS HealthCare of KY, Inc dba Vangard Labs QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7988_087b49e9-6968-4472-8a97-fa2d71f8a001 0615-7988 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 NCS HealthCare of KY, Inc dba Vangard Labs QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0615-7989_e6ec8718-1f3a-458c-a898-24abacd500b7 0615-7989 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 NCS HealthCare of KY, Inc dba Vangard Labs SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7990_e6ec8718-1f3a-458c-a898-24abacd500b7 0615-7990 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 NCS HealthCare of KY, Inc dba Vangard Labs SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7991_e6ec8718-1f3a-458c-a898-24abacd500b7 0615-7991 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 NCS HealthCare of KY, Inc dba Vangard Labs SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-7992_24333c18-52ab-4e87-98a9-c75ca42161ed 0615-7992 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070612 ANDA ANDA078103 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7993_24333c18-52ab-4e87-98a9-c75ca42161ed 0615-7993 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070614 ANDA ANDA078103 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-7995_65c21206-956c-489d-bb9a-e9c33c95eeb4 0615-7995 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078225 NCS HealthCare of KY, Inc dba Vangard Labs TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0615-7996_ebc924ad-e1dc-4018-9498-b4de257b30e8 0615-7996 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130401 ANDA ANDA091283 NCS HealthCare of KY, Inc dba Vangard Labs TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0615-7997_2eef53ea-f847-4bf9-bfa2-bf2f056800af 0615-7997 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 NCS HealthCare of KY, Inc dba Vangard Labs TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0615-7998_0cb61e77-99a9-4eec-b08d-20147df462f9 0615-7998 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071219 ANDA ANDA077056 NCS HealthCare of KY, Inc dba Vangard Labs PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 0615-7999_4dd3df34-112d-446f-b7cb-a05e623c489a 0615-7999 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 NCS HealthCare of KY, Inc dba Vangard Labs ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-8000_4dd3df34-112d-446f-b7cb-a05e623c489a 0615-8000 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 NCS HealthCare of KY, Inc dba Vangard Labs ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-8001_4a6e41cc-7c10-411b-81fa-fc8e791b7d72 0615-8001 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960918 ANDA ANDA074569 NCS HealthCare of KY, Inc dba Vangard Labs CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-8002_4a6e41cc-7c10-411b-81fa-fc8e791b7d72 0615-8002 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960917 ANDA ANDA074569 NCS HealthCare of KY, Inc dba Vangard Labs CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-8003_8c995d4f-2a20-4210-bfff-08c9183db168 0615-8003 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20060510 ANDA ANDA077754 NCS HealthCare of KY, Inc dba Vangard Labs LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-8004_8c995d4f-2a20-4210-bfff-08c9183db168 0615-8004 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 ANDA ANDA077754 NCS HealthCare of KY, Inc dba Vangard Labs LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-8005_979ed22f-1878-46d0-ae82-a873536c7ff4 0615-8005 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 NCS HealthCare of KY, Inc dba Vangard Labs TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 0615-8006_49d3fb85-9149-4f2c-973b-fb86f55824ae 0615-8006 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 NCS HealthCare of KY, Inc dba Vangard Labs ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-8007_611aa19e-b0d3-4cb5-ac19-03a70c15c482 0615-8007 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 NCS HealthCare of KY, Inc dba Vangard Labs ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-8008_611aa19e-b0d3-4cb5-ac19-03a70c15c482 0615-8008 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 NCS HealthCare of KY, Inc dba Vangard Labs ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-8009_611aa19e-b0d3-4cb5-ac19-03a70c15c482 0615-8009 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 NCS HealthCare of KY, Inc dba Vangard Labs ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-8010_9cf5c2a0-7641-4fc7-952d-3e003cc8519f 0615-8010 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930401 ANDA ANDA073589 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0615-8011_9cf5c2a0-7641-4fc7-952d-3e003cc8519f 0615-8011 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930101 ANDA ANDA073607 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0615-8012_a3144695-63d5-44bb-88f8-3d838baa075d 0615-8012 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 NCS HealthCare of KY, Inc dba Vangard Labs LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 0615-8013_15eddc5d-c1a4-41d8-aabb-3055908d6257 0615-8013 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0615-8014_05145126-ca1e-409b-b854-7c40b8802f52 0615-8014 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076274 NCS HealthCare of KY, Inc dba Vangard Labs CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 0615-8015_1a29ed1e-73ae-4cf3-8b42-de81a2d922b2 0615-8015 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 NCS HealthCare of KY, Inc dba Vangard Labs METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0615-8016_9eaad06c-f698-4651-b539-555808271337 0615-8016 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19931223 ANDA ANDA076704 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-8017_9eaad06c-f698-4651-b539-555808271337 0615-8017 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19931223 ANDA ANDA076704 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-8018_ccdabefe-92c2-48c1-b690-2f721af7612c 0615-8018 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 NCS HealthCare of KY, Inc dba Vangard Labs CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0615-8019_fe11b422-811b-4de4-8d2f-2b8961de9b4b 0615-8019 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-8020_57041ea1-a14e-483e-a41b-1bea65bb87ed 0615-8020 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20060905 ANDA ANDA040684 NCS HealthCare of KY, Inc dba Vangard Labs PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0615-8021_1a187934-2a23-4073-a35a-9cad6d25a741 0615-8021 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 NCS HealthCare of KY, Inc dba Vangard Labs RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0615-8022_91dcfd9a-bd71-4263-b458-6aa00e678e98 0615-8022 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-8023_91dcfd9a-bd71-4263-b458-6aa00e678e98 0615-8023 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 NCS HealthCare of KY, Inc dba Vangard Labs CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-8024_0841bbbb-efc2-4b73-a28c-e8ffa11a6a92 0615-8024 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20061121 NDA AUTHORIZED GENERIC NDA019962 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-8025_0841bbbb-efc2-4b73-a28c-e8ffa11a6a92 0615-8025 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20070802 NDA AUTHORIZED GENERIC NDA019962 NCS HealthCare of KY, Inc dba Vangard Labs METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-8026_c7f285c4-d72e-4dce-b11e-13179d6816c5 0615-8026 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 NCS HealthCare of KY, Inc dba Vangard Labs ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-8027_c7f285c4-d72e-4dce-b11e-13179d6816c5 0615-8027 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 NCS HealthCare of KY, Inc dba Vangard Labs ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0615-8029_35ecd4cc-5449-46ac-9088-c7beea5eff36 0615-8029 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 NCS HealthCare of KY, Inc dba Vangard Labs PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-8030_35ecd4cc-5449-46ac-9088-c7beea5eff36 0615-8030 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 NCS HealthCare of KY, Inc dba Vangard Labs PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-8031_a15f61fe-129d-49ef-a8bc-ca570308ff2d 0615-8031 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 NCS HealthCare of KY, Inc dba Vangard Labs SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0615-8032_2941a8d2-71af-4a56-96c5-8bfd1f893811 0615-8032 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-8033_2941a8d2-71af-4a56-96c5-8bfd1f893811 0615-8033 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 NCS HealthCare of KY, Inc dba Vangard Labs DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0615-8034_a445e86b-e120-4b61-96b6-bb49075a7057 0615-8034 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 NCS HealthCare of KY, Inc dba Vangard Labs DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-8035_a445e86b-e120-4b61-96b6-bb49075a7057 0615-8035 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 NCS HealthCare of KY, Inc dba Vangard Labs DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-8036_e5cb6f09-292f-4f13-bcdf-4365affa0b6f 0615-8036 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20120807 ANDA ANDA075640 NCS HealthCare of KY, Inc dba Vangard Labs HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0615-8037_120a6264-0f31-4536-884a-1ce5a1805331 0615-8037 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0615-8038_312eea20-ed53-41d0-8250-893f907b93ad 0615-8038 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 NCS HealthCare of KY, Inc dba Vangard Labs METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0615-8040_b08aff5e-0144-439b-9aa2-934e010874a4 0615-8040 HUMAN PRESCRIPTION DRUG MELOXICAM meloxicam TABLET ORAL 20060719 ANDA ANDA077929 NCS HealthCare of KY, Inc dba Vangard Labs MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-8041_56fe6868-6bbc-4110-a86a-710da2e1f85b 0615-8041 HUMAN OTC DRUG Docusate Sodium Docusate sodium CAPSULE, LIQUID FILLED ORAL 20081028 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE SODIUM 100 mg/1 N 20181231 0615-8043_d2fa087f-42a8-40a0-80af-616447be1c95 0615-8043 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET ORAL 20131219 ANDA ANDA075395 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-8044_d2fa087f-42a8-40a0-80af-616447be1c95 0615-8044 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET ORAL 20131219 ANDA ANDA075395 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0615-8045_5e2ec8ab-4f3d-4ab6-ae6f-875e9e9866b3 0615-8045 HUMAN PRESCRIPTION DRUG KLOR-CON potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140901 NDA NDA019123 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0615-8046_2be598d6-8a01-4fa5-a5d1-12af11f15747 0615-8046 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076410 NCS HealthCare of KY, Inc dba Vangard Labs ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0615-8047_2be598d6-8a01-4fa5-a5d1-12af11f15747 0615-8047 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076410 NCS HealthCare of KY, Inc dba Vangard Labs ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0615-8048_4a6e41cc-7c10-411b-81fa-fc8e791b7d72 0615-8048 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960918 ANDA ANDA074569 NCS HealthCare of KY, Inc dba Vangard Labs CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-8049_da629ad2-fe6d-40fd-8c3a-8f9e82a75750 0615-8049 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 19850904 ANDA ANDA070325 NCS HealthCare of KY, Inc dba Vangard Labs DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-8050_8c995d4f-2a20-4210-bfff-08c9183db168 0615-8050 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 ANDA ANDA077754 NCS HealthCare of KY, Inc dba Vangard Labs LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-8051_d6519dc3-d200-46c4-bc6b-238b6d78b221 0615-8051 HUMAN OTC DRUG Aspir Low Aspirin TABLET ORAL 20110524 OTC MONOGRAPH FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ASPIRIN 81 mg/1 N 20181231 0615-8052_81e651f0-e1b5-4384-90b2-ce4be6c19bd7 0615-8052 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 NCS HealthCare of KY, Inc dba Vangard Labs MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 0615-8053_00da8cd8-1651-4a65-9bb6-1a2d66772ca9 0615-8053 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20160321 ANDA ANDA202554 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-8054_00da8cd8-1651-4a65-9bb6-1a2d66772ca9 0615-8054 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160321 ANDA ANDA202554 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-8055_01d3ec05-a1ad-4ad6-b001-51e76751164d 0615-8055 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 NCS HealthCare of KY, Inc dba Vangard Labs TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0615-8056_c0f564ec-ed49-42ec-bf86-5be366d57adb 0615-8056 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20151202 ANDA ANDA078103 NCS HealthCare of KY, Inc dba Vangard Labs SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0615-8057_00da8cd8-1651-4a65-9bb6-1a2d66772ca9 0615-8057 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20160321 ANDA ANDA202554 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-8058_8f19f56d-8f19-48e7-8965-ca33e84278d3 0615-8058 HUMAN OTC DRUG Aspirin aspirin TABLET, COATED ORAL 20140114 OTC MONOGRAPH FINAL part343 NCS HealthCare of KY, Inc dba Vangard Labs ASPIRIN 81 mg/1 N 20181231 0615-8061_28034e7d-eb5f-48d6-80e8-c6e71ca84fb2 0615-8061 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-8062_28034e7d-eb5f-48d6-80e8-c6e71ca84fb2 0615-8062 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-8063_28034e7d-eb5f-48d6-80e8-c6e71ca84fb2 0615-8063 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-8064_28034e7d-eb5f-48d6-80e8-c6e71ca84fb2 0615-8064 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-8065_28034e7d-eb5f-48d6-80e8-c6e71ca84fb2 0615-8065 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 NCS HealthCare of KY, Inc dba Vangard Labs LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0615-8066_1a227bd2-1848-41f2-a570-26385d493c72 0615-8066 HUMAN PRESCRIPTION DRUG Klor-Con Sprinkle Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20150710 ANDA ANDA203106 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0615-8067_ca2c5f0d-b947-424f-ba20-124b86532bdc 0615-8067 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20160718 ANDA ANDA074260 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0615-8068_ca2c5f0d-b947-424f-ba20-124b86532bdc 0615-8068 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20160718 ANDA ANDA074260 NCS HealthCare of KY, Inc dba Vangard Labs CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0615-8071_48b203da-2af0-43f7-8364-6c522c917f92 0615-8071 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 NCS HealthCare of KY, Inc dba Vangard Labs METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0615-8075_8a2102e0-8e0a-470d-a4e1-55c3ce985715 0615-8075 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 NCS HealthCare of KY, Inc dba Vangard Labs LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-8076_8a2102e0-8e0a-470d-a4e1-55c3ce985715 0615-8076 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 NCS HealthCare of KY, Inc dba Vangard Labs LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-8077_8a2102e0-8e0a-470d-a4e1-55c3ce985715 0615-8077 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 NCS HealthCare of KY, Inc dba Vangard Labs LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0615-8078_b37781a2-b985-45d2-aa9b-027f45af4c99 0615-8078 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20040422 ANDA ANDA076541 NCS HealthCare of KY, Inc dba Vangard Labs MIRTAZAPINE 7.5 mg/1 N 20181231 0615-8079_fb409783-31ea-4618-a1b7-68ca2db8ecc7 0615-8079 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 NCS HealthCare of KY, Inc dba Vangard Labs OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0615-8082_399f7c41-92f1-407d-ba79-d79e63a122d2 0615-8082 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 NCS HealthCare of KY, Inc dba Vangard Labs HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0615-8083_8a0a7cfe-4de4-4f12-b923-1dbc917a1847 0615-8083 HUMAN OTC DRUG SENEXON-S DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20110316 OTC MONOGRAPH NOT FINAL part334 NCS HealthCare of KY, Inc dba Vangard Labs DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 N 20181231 0615-8084_52e4f18d-44e2-4548-bff4-188939ef7eac 0615-8084 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 NCS HealthCare of KY, Inc dba Vangard Labs CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0615-8085_854ea2c4-ffab-4087-a119-1030a9b0fee0 0615-8085 HUMAN PRESCRIPTION DRUG Klor-Con Sprinkle Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20150710 ANDA ANDA203106 NCS HealthCare of KY, Inc dba Vangard Labs POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0615-8087_091e9385-faad-4436-a762-7f00e025c61f 0615-8087 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 19910918 ANDA ANDA072741 NCS HealthCare of KY, Inc dba Vangard Labs LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 0615-8088_1a17a9d8-e17e-4ca3-a903-07d700a4a3a0 0615-8088 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20121128 ANDA ANDA090168 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0615-8089_1a17a9d8-e17e-4ca3-a903-07d700a4a3a0 0615-8089 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20121128 ANDA ANDA090168 NCS HealthCare of KY, Inc dba Vangard Labs BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0615-8090_4de41b32-aa63-4cb9-bd9c-fdc65887fa73 0615-8090 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20141008 ANDA ANDA201658 NCS HealthCare of KY, Inc dba Vangard Labs CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0615-8093_ae147621-61cb-4303-b340-23500a18f0f5 0615-8093 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 NCS HealthCare of KY, Inc dba Vangard Labs FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0615-8094_0aa460fe-3ac9-4b38-8e2b-8a59e5cb3563 0615-8094 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 NCS HealthCare of KY, Inc dba Vangard Labs NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0615-8095_55042210-a61c-4abe-b9fc-420a23c6c123 0615-8095 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-8096_55042210-a61c-4abe-b9fc-420a23c6c123 0615-8096 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-8097_55042210-a61c-4abe-b9fc-420a23c6c123 0615-8097 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-8098_839ad42c-4c4d-4937-ac42-0e4488bbd29a 0615-8098 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 NCS HealthCare of KY, Inc dba Vangard Labs GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0615-8100_6d81d2c0-bedf-4ea7-99f9-b579f4d6abdf 0615-8100 HUMAN PRESCRIPTION DRUG Memantine Memantine TABLET ORAL 20150711 ANDA ANDA090048 NCS HealthCare of KY, Inc dba Vangard Labs MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0615-8102_36007ccd-229c-410c-877a-00d6c3b5f898 0615-8102 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170105 ANDA ANDA202800 NCS HealthCare of KY, Inc dba Vangard Labs ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0615-8103_e96b8bfd-5d0b-49f9-80a7-49bebf7cad4b 0615-8103 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 20170420 ANDA ANDA073281 NCS HealthCare of KY, Inc dba Vangard Labs TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0615-8143_2aa7ba67-45e7-44cd-89ca-856e356ffd9e 0615-8143 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 NCS HealthCare of KY, Inc dba Vangard Labs BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 0615-8178_ec30bfb1-a855-4a0d-9ee4-31ab6dc8ca4f 0615-8178 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170602 ANDA ANDA203512 NCS HealthCare of KY, Inc dba Vangard Labs SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0615-8193_26373e72-d9e2-4ee9-ae3b-925344a3bfcd 0615-8193 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19830210 ANDA ANDA087946 NCS HealthCare of KY, Inc dba Vangard Labs ISOSORBIDE DINITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 0615-8194_db403a97-6c30-4577-b601-4d4b48320a6e 0615-8194 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040627 NCS HealthCare of KY, Inc dba Vangard Labs BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 0641-0121_5995b5b5-abb9-4d8b-ae0c-d7ff7888ee9e 0641-0121 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19720101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-0367_6f0dbcab-275d-4c82-8702-44508a85e5ac 0641-0367 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION INTRAMUSCULAR; INTRAVENOUS 19820907 ANDA ANDA087702 West-Ward Pharmaceuticals Corp. DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0641-0376_be14178b-bc59-44f5-b793-45bac461eb4c 0641-0376 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19721127 ANDA ANDA080817 West-ward Pharmaceutical Corp. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0641-0391_d641533c-2999-4ef1-9955-3e8d0a6328e9 0641-0391 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19720322 NDA NDA017037 West-Ward Pharmaceuticals Corp. HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0641-0400_d641533c-2999-4ef1-9955-3e8d0a6328e9 0641-0400 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19720322 NDA NDA017037 West-Ward Pharmaceuticals Corp. HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0641-0410_d641533c-2999-4ef1-9955-3e8d0a6328e9 0641-0410 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19720322 NDA NDA017037 West-Ward Pharmaceuticals Corp. HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0641-0476_78aecf93-f2bf-4179-a68c-8f25be4d1d4c 0641-0476 HUMAN PRESCRIPTION DRUG Phenobarbital Sodium Phenobarbital Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. PHENOBARBITAL SODIUM 65 mg/mL CIV N 20181231 0641-0477_78aecf93-f2bf-4179-a68c-8f25be4d1d4c 0641-0477 HUMAN PRESCRIPTION DRUG Phenobarbital Sodium Phenobarbital Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. PHENOBARBITAL SODIUM 130 mg/mL CIV N 20181231 0641-0491_7b251584-d98e-459b-9a71-8574bd5733d1 0641-0491 HUMAN PRESCRIPTION DRUG Prochlorperazine Edisylate Prochlorperazine Edisylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110114 ANDA ANDA089903 Baxter Healthcare Corporation PROCHLORPERAZINE EDISYLATE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 0641-0493_b6363020-7bf8-4eb0-a810-3f93858651f3 0641-0493 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19750716 ANDA ANDA084307 West-Ward Pharmaceuticals Corp. PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20191231 0641-0497_f899c3cf-cf97-4c42-84e9-2c3cf788c8d5 0641-0497 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20130924 ANDA ANDA201833 West-Ward Pharmaceutical Corp. SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0641-0928_d224d3b9-d5c2-40a7-8e1b-333a5362ba01 0641-0928 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-0929_d224d3b9-d5c2-40a7-8e1b-333a5362ba01 0641-0929 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-0948_fe649048-d0d1-448a-8c52-0aff4f672d19 0641-0948 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-0949_fe649048-d0d1-448a-8c52-0aff4f672d19 0641-0949 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-0955_2cd5722b-7cf2-4460-bcb7-50221dec5372 0641-0955 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-0956_2cd5722b-7cf2-4460-bcb7-50221dec5372 0641-0956 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-1397_d63e4be9-112e-4efc-b1cc-1c3081c01647 0641-1397 HUMAN PRESCRIPTION DRUG Chlorpromazine hydrochloride Chlorpromazine hydrochloride INJECTION INTRAMUSCULAR 19740725 ANDA ANDA083329 West-Ward Pharmaceuticals Corp. CHLORPROMAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-1398_d63e4be9-112e-4efc-b1cc-1c3081c01647 0641-1398 HUMAN PRESCRIPTION DRUG Chlorpromazine hydrochloride Chlorpromazine hydrochloride INJECTION INTRAMUSCULAR 19740725 ANDA ANDA083329 West-Ward Pharmaceuticals Corp. CHLORPROMAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-1410_4c5ebfb9-b6b6-4184-9b8c-641be7484328 0641-1410 HUMAN PRESCRIPTION DRUG Digoxin Digoxin INJECTION INTRAMUSCULAR; INTRAVENOUS 19751024 ANDA ANDA083391 West-Ward Pharmaceuticals Corp. DIGOXIN .25 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0641-1495_f9a92eee-c65d-461e-94b9-ac19c6529854 0641-1495 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-1496_f9a92eee-c65d-461e-94b9-ac19c6529854 0641-1496 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-1512_87112666-5d03-4e58-996e-bd2eecf8d5d7 0641-1512 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120120 ANDA ANDA201850 West-ward Pharmaceutical Corp. SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0641-2341_5995b5b5-abb9-4d8b-ae0c-d7ff7888ee9e 0641-2341 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19720101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-2450_d641533c-2999-4ef1-9955-3e8d0a6328e9 0641-2450 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19720322 NDA NDA017037 West-Ward Pharmaceuticals Corp. HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0641-2460_d641533c-2999-4ef1-9955-3e8d0a6328e9 0641-2460 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19720322 NDA NDA017037 West-Ward Pharmaceuticals Corp. HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0641-2555_b6363020-7bf8-4eb0-a810-3f93858651f3 0641-2555 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19750716 ANDA ANDA084307 West-Ward Pharmaceuticals Corp. PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20191231 0641-2569_2d18d851-d842-476c-b1c4-8b1b332e6c76 0641-2569 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole INJECTION INTRAVENOUS 19961018 ANDA ANDA074521 West-ward Pharmaceutical Corp. DIPYRIDAMOLE 5 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0641-2965_9adad150-da57-4281-bfab-7780c25f26a6 0641-2965 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE INJECTION INTRAVENOUS 19861231 NDA NDA019386 West Ward Pharmaceutical Corporation ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 0641-6000_434be84c-76e8-436c-b8d5-e734a6ec359c 0641-6000 HUMAN PRESCRIPTION DRUG Ativan Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6001_434be84c-76e8-436c-b8d5-e734a6ec359c 0641-6001 HUMAN PRESCRIPTION DRUG Ativan Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6002_434be84c-76e8-436c-b8d5-e734a6ec359c 0641-6002 HUMAN PRESCRIPTION DRUG Ativan Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6003_434be84c-76e8-436c-b8d5-e734a6ec359c 0641-6003 HUMAN PRESCRIPTION DRUG Ativan Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6006_b5db2b41-ad60-4a44-927c-c260e56c4cdc 0641-6006 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19710101 UNAPPROVED DRUG OTHER West-ward Pharmaceutical Corp. ATROPINE SULFATE .4 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0641-6007_ec8f38ae-3812-4540-aac6-b2df8f528f5d 0641-6007 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20080430 ANDA ANDA079196 West-ward Pharmaceutical Corp. BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0641-6008_ec8f38ae-3812-4540-aac6-b2df8f528f5d 0641-6008 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20080430 ANDA ANDA079196 West-ward Pharmaceutical Corp. BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0641-6013_832970c9-88cb-4694-9e32-380135b9f5c8 0641-6013 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20081217 ANDA ANDA078538 West-ward Pharmaceutical Corp. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0641-6014_832970c9-88cb-4694-9e32-380135b9f5c8 0641-6014 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20081217 ANDA ANDA078538 West-ward Pharmaceutical Corp. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0641-6015_832970c9-88cb-4694-9e32-380135b9f5c8 0641-6015 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20081217 ANDA ANDA078538 West-ward Pharmaceutical Corp. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0641-6018_7c74602f-5167-4f3d-8912-f6016b2eb99e 0641-6018 HUMAN PRESCRIPTION DRUG Dopram Doxapram hydrochloride INJECTION INTRAVENOUS 19650623 NDA NDA014879 West-ward Pharmaceutical Corp. DOXAPRAM HYDROCHLORIDE 20 mg/mL Increased Medullary Respiratory Drive [PE],Respiratory Stimulant [EPC] N 20181231 0641-6019_c233fb1e-05e1-4265-a0fe-473b1c3446ae 0641-6019 HUMAN PRESCRIPTION DRUG Duramorph morphine sulfate INJECTION EPIDURAL; INTRATHECAL; INTRAVENOUS 19840918 NDA NDA018565 West-Ward Pharmaceuticals Corp. MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6020_c233fb1e-05e1-4265-a0fe-473b1c3446ae 0641-6020 HUMAN PRESCRIPTION DRUG Duramorph morphine sulfate INJECTION EPIDURAL; INTRATHECAL; INTRAVENOUS 19840918 NDA NDA018565 West-Ward Pharmaceuticals Corp. MORPHINE SULFATE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6021_08840114-5001-4779-9471-1957a73d7961 0641-6021 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION INTRAVENOUS 20010416 ANDA ANDA075488 West-ward Pharmaceutical Corp. FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0641-6022_08840114-5001-4779-9471-1957a73d7961 0641-6022 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION INTRAVENOUS 20010416 ANDA ANDA075486 West-ward Pharmaceutical Corp. FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0641-6023_08840114-5001-4779-9471-1957a73d7961 0641-6023 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION INTRAVENOUS 20010416 ANDA ANDA075488 West-ward Pharmaceutical Corp. FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0641-6024_700c7373-b1ba-4e64-a89c-d164dc3f38e1 0641-6024 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 19840711 NDA NDA019101 West-Ward Pharmaceuticals Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6025_700c7373-b1ba-4e64-a89c-d164dc3f38e1 0641-6025 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 19840711 NDA NDA019101 West-Ward Pharmaceuticals Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6026_700c7373-b1ba-4e64-a89c-d164dc3f38e1 0641-6026 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAVENOUS 19840711 NDA NDA019101 West-Ward Pharmaceuticals Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6027_700c7373-b1ba-4e64-a89c-d164dc3f38e1 0641-6027 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 19840711 NDA NDA019101 West-Ward Pharmaceuticals Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6028_700c7373-b1ba-4e64-a89c-d164dc3f38e1 0641-6028 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 19840711 NDA NDA019101 West-Ward Pharmaceuticals Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6029_700c7373-b1ba-4e64-a89c-d164dc3f38e1 0641-6029 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAVENOUS 19840711 NDA NDA019101 West-Ward Pharmaceuticals Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6030_700c7373-b1ba-4e64-a89c-d164dc3f38e1 0641-6030 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION INTRAVENOUS 19840711 NDA NDA019101 West-Ward Pharmaceuticals Corp. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6031_d441809f-34f5-4ad8-ad17-9f224aa329ff 0641-6031 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20041012 ANDA ANDA076787 West-ward Pharmaceutical Corp. FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 0641-6032_d441809f-34f5-4ad8-ad17-9f224aa329ff 0641-6032 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20041012 ANDA ANDA076787 West-ward Pharmaceutical Corp. FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 0641-6033_d2cb6514-ba29-4b95-b9a1-6cd21a5e2371 0641-6033 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-ward Pharmaceutical Corp. GLYCOPYRROLATE .2 mg/mL N 20181231 0641-6034_d2cb6514-ba29-4b95-b9a1-6cd21a5e2371 0641-6034 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-ward Pharmaceutical Corp. GLYCOPYRROLATE .2 mg/mL N 20181231 0641-6035_d2cb6514-ba29-4b95-b9a1-6cd21a5e2371 0641-6035 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-ward Pharmaceutical Corp. GLYCOPYRROLATE .2 mg/mL N 20181231 0641-6036_d2cb6514-ba29-4b95-b9a1-6cd21a5e2371 0641-6036 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-ward Pharmaceutical Corp. GLYCOPYRROLATE .2 mg/mL N 20181231 0641-6039_1657bd36-00a4-417a-ae7e-3406670b4a2e 0641-6039 HUMAN PRESCRIPTION DRUG INFUMORPH 200 morphine sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL 19840918 NDA NDA018565 West-Ward Pharmaceuticals Corp. MORPHINE SULFATE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6040_1657bd36-00a4-417a-ae7e-3406670b4a2e 0641-6040 HUMAN PRESCRIPTION DRUG INFUMORPH 500 morphine sulfate INJECTION, SOLUTION EPIDURAL; INTRATHECAL 19840918 NDA NDA018565 West-Ward Pharmaceuticals Corp. MORPHINE SULFATE 25 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6042_2f4d6291-cdb3-4928-9e62-2da4d179b72e 0641-6042 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION INTRAMUSCULAR; INTRAVENOUS 20040721 ANDA ANDA075772 West-Ward Pharmaceuticals Corp. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0641-6043_2f4d6291-cdb3-4928-9e62-2da4d179b72e 0641-6043 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION INTRAMUSCULAR 20040721 ANDA ANDA075772 West-Ward Pharmaceuticals Corp. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 0641-6044_f7e4a0a2-ad12-4925-a942-89a7a16b4156 0641-6044 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6045_f7e4a0a2-ad12-4925-a942-89a7a16b4156 0641-6045 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6046_f7e4a0a2-ad12-4925-a942-89a7a16b4156 0641-6046 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6047_f7e4a0a2-ad12-4925-a942-89a7a16b4156 0641-6047 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6048_43a82cce-6939-4e56-ab2d-fd5510e0414b 0641-6048 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6049_43a82cce-6939-4e56-ab2d-fd5510e0414b 0641-6049 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6050_43a82cce-6939-4e56-ab2d-fd5510e0414b 0641-6050 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6051_43a82cce-6939-4e56-ab2d-fd5510e0414b 0641-6051 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 4 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6052_d88c088a-4e6b-4a75-a2d7-99babc5ce32b 0641-6052 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19750122 ANDA ANDA080445 West-ward Pharmaceutical Corp. MEPERIDINE HYDROCHLORIDE 25 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6053_d88c088a-4e6b-4a75-a2d7-99babc5ce32b 0641-6053 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19750122 ANDA ANDA080445 West-ward Pharmaceutical Corp. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6054_d88c088a-4e6b-4a75-a2d7-99babc5ce32b 0641-6054 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19750122 ANDA ANDA080445 West-ward Pharmaceutical Corp. MEPERIDINE HYDROCHLORIDE 100 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6056_d19cd22b-7293-4542-845a-36c372370bda 0641-6056 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-Ward Pharmaceuticals Corp. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6057_d19cd22b-7293-4542-845a-36c372370bda 0641-6057 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-Ward Pharmaceuticals Corp. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6059_d19cd22b-7293-4542-845a-36c372370bda 0641-6059 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-Ward Pharmaceuticals Corp. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6060_d19cd22b-7293-4542-845a-36c372370bda 0641-6060 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-Ward Pharmaceuticals Corp. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6061_d19cd22b-7293-4542-845a-36c372370bda 0641-6061 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-Ward Pharmaceuticals Corp. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6063_d19cd22b-7293-4542-845a-36c372370bda 0641-6063 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-Ward Pharmaceuticals Corp. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6065_7fdfbdfe-52fe-48c5-a44a-a4f09cd415ea 0641-6065 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION INTRAVENOUS 20020528 ANDA ANDA075530 West-ward Pharmaceutical Corp. MILRINONE LACTATE 1 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0641-6067_7fdfbdfe-52fe-48c5-a44a-a4f09cd415ea 0641-6067 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION INTRAVENOUS 20020528 ANDA ANDA075530 West-ward Pharmaceutical Corp. MILRINONE LACTATE 1 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 0641-6078_2d43f53b-d7ab-42dd-a380-c81cf9261816 0641-6078 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077541 West-Ward Pharmaceuticals Corp. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0641-6079_2d43f53b-d7ab-42dd-a380-c81cf9261816 0641-6079 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077365 West-Ward Pharmaceuticals Corp. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0641-6080_77af358e-f094-4451-9d29-f6d69823c83d 0641-6080 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077541 West-Ward Pharmaceuticals Corp. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0641-6082_1cee9794-5b56-4d41-a27e-86ba9cbf831d 0641-6082 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-6083_1cee9794-5b56-4d41-a27e-86ba9cbf831d 0641-6083 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-6084_d04e641a-8b8a-4756-9946-3a2664f66562 0641-6084 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-6085_d04e641a-8b8a-4756-9946-3a2664f66562 0641-6085 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride INJECTION INTRAMUSCULAR 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-6099_42359b1f-53f4-499c-871f-1c0485d56d2c 0641-6099 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-ward Pharmaceutical Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-6103_3d89bb2e-84a2-4c45-a03f-89ac79f15c21 0641-6103 HUMAN PRESCRIPTION DRUG ROBAXIN methocarbamol INJECTION INTRAMUSCULAR; INTRAVENOUS 19590616 NDA NDA011790 West-Ward Pharmaceuticals Corp. METHOCARBAMOL 100 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0641-6104_e4a973a8-5fc7-43d8-9bbe-14ce4cb7ded2 0641-6104 HUMAN PRESCRIPTION DRUG Robinul Robinul INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-Ward Pharmaceuticals Corp. GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0641-6105_e4a973a8-5fc7-43d8-9bbe-14ce4cb7ded2 0641-6105 HUMAN PRESCRIPTION DRUG Robinul Robinul INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-Ward Pharmaceuticals Corp. GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0641-6106_e4a973a8-5fc7-43d8-9bbe-14ce4cb7ded2 0641-6106 HUMAN PRESCRIPTION DRUG Robinul Robinul INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-Ward Pharmaceuticals Corp. GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0641-6107_e4a973a8-5fc7-43d8-9bbe-14ce4cb7ded2 0641-6107 HUMAN PRESCRIPTION DRUG Robinul Robinul INJECTION INTRAMUSCULAR; INTRAVENOUS 19750206 NDA NDA017558 West-Ward Pharmaceuticals Corp. GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0641-6110_665e04c2-df92-4967-a8d9-0717eaf9d279 0641-6110 HUMAN PRESCRIPTION DRUG Sufentanil Citrate Sufentanil Citrate INJECTION EPIDURAL; INTRAVENOUS 19951215 ANDA ANDA074413 West-ward Pharmaceutical Corp. SUFENTANIL CITRATE .05 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6111_665e04c2-df92-4967-a8d9-0717eaf9d279 0641-6111 HUMAN PRESCRIPTION DRUG Sufentanil Citrate Sufentanil Citrate INJECTION EPIDURAL; INTRAVENOUS 19951215 ANDA ANDA074413 West-ward Pharmaceutical Corp. SUFENTANIL CITRATE .05 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6112_665e04c2-df92-4967-a8d9-0717eaf9d279 0641-6112 HUMAN PRESCRIPTION DRUG Sufentanil Citrate Sufentanil Citrate INJECTION EPIDURAL; INTRAVENOUS 19951215 ANDA ANDA074413 West-ward Pharmaceutical Corp. SUFENTANIL CITRATE .05 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6113_b1d995ba-93ec-4d06-b459-9545f2a1b3f6 0641-6113 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION INTRAVENOUS 20040616 ANDA ANDA076500 West-ward Pharmaceutical Corp. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 0641-6114_58b5f701-ca81-4dad-8f1e-33caf7d5ebf9 0641-6114 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION INTRAMUSCULAR; INTRAVENOUS 19800429 NDA NDA018243 West-Ward Pharmaceutical Corp. OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] N 20181231 0641-6115_58b5f701-ca81-4dad-8f1e-33caf7d5ebf9 0641-6115 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION INTRAMUSCULAR; INTRAVENOUS 19800429 NDA NDA018243 West-Ward Pharmaceutical Corp. OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] N 20181231 0641-6116_a011bf6f-3749-4bb2-8f97-555e535a19b6 0641-6116 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091222 ANDA ANDA065406 West-Ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1.5g; g/1.5g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0641-6117_a011bf6f-3749-4bb2-8f97-555e535a19b6 0641-6117 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091222 ANDA ANDA065406 West-Ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/3g; g/3g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0641-6118_d74b6e81-a28f-4f3e-855d-bbcb4842fa4a 0641-6118 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091203 ANDA ANDA065403 West-Ward Pharmaceuticals Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0641-6119_64f98f79-9446-46c3-b57c-0e671ce9abc3 0641-6119 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091222 ANDA ANDA065406 West-Ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1.5g; g/1.5g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] E 20171231 0641-6120_64f98f79-9446-46c3-b57c-0e671ce9abc3 0641-6120 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091222 ANDA ANDA065406 West-Ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/3g; g/3g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] E 20171231 0641-6121_68fc19c6-3431-4c1d-bd50-b685aae800d6 0641-6121 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091203 ANDA ANDA065403 West-Ward Pharmaceuticals Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0641-6122_d04b9c2b-a783-4713-ba8d-8bbc513499a8 0641-6122 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091222 ANDA ANDA065406 West-ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0641-6123_d04b9c2b-a783-4713-ba8d-8bbc513499a8 0641-6123 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091222 ANDA ANDA065406 West-ward Pharmaceutical Corp. AMPICILLIN SODIUM; SULBACTAM SODIUM 250; 125 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0641-6125_a5957925-ce8b-4bbc-97ff-99600bbda304 0641-6125 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAVENOUS 20150603 ANDA ANDA205758 West-Ward Pharmaceuticals Corp. MORPHINE SULFATE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6126_a5957925-ce8b-4bbc-97ff-99600bbda304 0641-6126 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAVENOUS 20150603 ANDA ANDA205758 West-Ward Pharmaceuticals Corp. MORPHINE SULFATE 8 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6127_a5957925-ce8b-4bbc-97ff-99600bbda304 0641-6127 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAVENOUS 20150603 ANDA ANDA205758 West-Ward Pharmaceuticals Corp. MORPHINE SULFATE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0641-6132_a90bbd23-5ec8-4755-86c9-67b1dbee75e7 0641-6132 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Nalxone Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19860924 ANDA ANDA070299 West-Ward Pharmaceuticals Corp. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 0641-6135_3ee80419-d693-4b47-a46e-a585ce8883df 0641-6135 HUMAN PRESCRIPTION DRUG Prochlorperazine Edisylate Prochlorperazine Edisylate INJECTION INTRAMUSCULAR; INTRAVENOUS 19890829 ANDA ANDA089903 West-Ward Pharmaceuticals Corp. PROCHLORPERAZINE EDISYLATE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-6136_e71c0044-1981-47bc-bf88-9836161b5034 0641-6136 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20070806 ANDA ANDA077989 West-Ward Pharmaceuticals Corp. FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0641-6137_e71c0044-1981-47bc-bf88-9836161b5034 0641-6137 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20070806 ANDA ANDA077989 West-Ward Pharmaceuticals Corp. FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0641-6138_4d601e0c-bee1-4e7a-a03a-cae39f54bcd2 0641-6138 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19750716 ANDA ANDA084307 West-Ward Pharmaceuticals Corp. PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20191231 0641-6139_4d601e0c-bee1-4e7a-a03a-cae39f54bcd2 0641-6139 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19750716 ANDA ANDA084307 West-Ward Pharmaceuticals Corp. PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20191231 0641-6142_1b182a73-a7a5-46d5-ab15-d960db190445 0641-6142 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride INJECTION INTRAVENOUS 20121218 NDA NDA203826 West-Ward Pharmaceutical Corp. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] N 20181231 0641-6144_f899c3cf-cf97-4c42-84e9-2c3cf788c8d5 0641-6144 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20130924 ANDA ANDA201833 West-Ward Pharmaceutical Corp. SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0641-6145_6f0dbcab-275d-4c82-8702-44508a85e5ac 0641-6145 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 19750715 ANDA ANDA084282 West-Ward Pharmaceuticals Corp. DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0641-6146_6f0dbcab-275d-4c82-8702-44508a85e5ac 0641-6146 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 19750715 ANDA ANDA084282 West-Ward Pharmaceuticals Corp. DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0641-6147_563b8faf-1a3a-446a-9ee9-2c3597ebf6e2 0641-6147 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20150903 ANDA ANDA206369 West-Ward Pharmaceuticals Corp. WATER 1 mL/mL N 20181231 0641-6149_fe9a09f7-6c45-4f71-bbcb-297ed0dc5af4 0641-6149 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate INJECTION INTRAVENOUS 20151228 ANDA ANDA207042 West-Ward Pharmaceuticals Corp. NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0641-6150_fe9a09f7-6c45-4f71-bbcb-297ed0dc5af4 0641-6150 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate INJECTION INTRAVENOUS 20151228 ANDA ANDA207042 West-Ward Pharmaceuticals Corp. NEOSTIGMINE METHYLSULFATE .5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0641-6154_c65184c7-48fb-41f7-aee9-aa431715403b 0641-6154 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol INJECTION INTRAVENOUS 20130830 ANDA ANDA091101 West-Ward Pharmaceutical Corp. DOXERCALCIFEROL 2 ug/mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 0641-6161_6df1303a-9cae-4b06-8f06-c1a7bc5371ce 0641-6161 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20080430 ANDA ANDA079196 West-Ward Pharmaceutical Corp. BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0641-6162_6df1303a-9cae-4b06-8f06-c1a7bc5371ce 0641-6162 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide INJECTION INTRAMUSCULAR; INTRAVENOUS 20080430 ANDA ANDA079196 West-Ward Pharmaceutical Corp. BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0641-6164_014f46e9-ee4f-48a8-a7b3-e70caa30084d 0641-6164 HUMAN PRESCRIPTION DRUG CAFCIT caffeine citrate INJECTION INTRAVENOUS 20081104 NDA NDA020793 West-Ward Pharmaceutical Corp. CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0641-6166_2c1889aa-ed85-4ed1-a4de-de804d41198a 0641-6166 HUMAN PRESCRIPTION DRUG Amikacin Sulfate Amikacin Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS 20150801 ANDA ANDA063315 West-Ward Pharmaceuticals Corp. AMIKACIN SULFATE 250 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0641-6167_2c1889aa-ed85-4ed1-a4de-de804d41198a 0641-6167 HUMAN PRESCRIPTION DRUG Amikacin Sulfate Amikacin Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS 20150801 ANDA ANDA063315 West-Ward Pharmaceuticals Corp. AMIKACIN SULFATE 250 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0641-6173_c1e0601b-692e-418d-a4af-a9e6a3a6ec37 0641-6173 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride INJECTION INTRAMUSCULAR 20151230 ANDA ANDA040465 West-Ward Pharmaceuticals Corp. DICYCLOMINE HYDROCHLORIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0641-6174_42fc483e-63ad-487d-9cfe-d1d9e85a73ad 0641-6174 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050404 ANDA ANDA076313 West-Ward Pharmaceuticals Corp. OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 0641-6175_42fc483e-63ad-487d-9cfe-d1d9e85a73ad 0641-6175 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050404 ANDA ANDA076313 West-Ward Pharmaceuticals Corp. OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 0641-6176_42fc483e-63ad-487d-9cfe-d1d9e85a73ad 0641-6176 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050404 ANDA ANDA076313 West-Ward Pharmaceuticals Corp. OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 0641-6177_42fc483e-63ad-487d-9cfe-d1d9e85a73ad 0641-6177 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050408 ANDA ANDA076330 West-Ward Pharmaceuticals Corp. OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 0641-6178_42fc483e-63ad-487d-9cfe-d1d9e85a73ad 0641-6178 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050408 ANDA ANDA076330 West-Ward Pharmaceuticals Corp. OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 0641-6182_470d2fa3-0d35-4fb2-9ec5-687a43b3a5af 0641-6182 HUMAN PRESCRIPTION DRUG Orphenadrine citrate Orphenadrine citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 20030428 ANDA ANDA040463 West-Ward Pharmaceuticals Corp. ORPHENADRINE CITRATE 60 mg/2mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0641-6184_33aff83d-657d-463d-9992-7dde3de0debc 0641-6184 HUMAN PRESCRIPTION DRUG Digoxin Digoxin INJECTION INTRAMUSCULAR; INTRAVENOUS 19751024 ANDA ANDA083391 West-Ward Pharmaceuticals Corp. DIGOXIN .25 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0641-6190_eb5fe22c-cc23-4d6d-bfb7-59a7df354ae3 0641-6190 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-Ward Pharmaceuticals Corp. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6207_3278accd-3636-48b4-b570-60af027807f4 0641-6207 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 West-Ward Pharmaceuticals Corp. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6208_daff41af-ced3-45c2-9f92-7bcf9e83feef 0641-6208 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 West-Ward Pharmaceuticals Corp. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0641-6209_76443368-91dc-49d9-b91e-753ed4e8852a 0641-6209 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-Ward Pharmaceuticals Corp. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6210_76443368-91dc-49d9-b91e-753ed4e8852a 0641-6210 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-Ward Pharmaceuticals Corp. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6211_76443368-91dc-49d9-b91e-753ed4e8852a 0641-6211 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 West-Ward Pharmaceuticals Corp. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0641-6217_66da57a1-bc7c-48d4-a47f-c3d58692dae9 0641-6217 HUMAN PRESCRIPTION DRUG ROBAXIN methocarbamol INJECTION INTRAMUSCULAR; INTRAVENOUS 20171017 NDA NDA011790 West-Ward Pharmaceuticals Corp. METHOCARBAMOL 100 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0641-9217_dc27760d-6f90-470c-9e81-34a0bbf4bb97 0641-9217 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20081217 ANDA ANDA078538 West-Ward Pharmaceuticals Corp. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0641-9218_dc27760d-6f90-470c-9e81-34a0bbf4bb97 0641-9218 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20081217 ANDA ANDA078538 West-Ward Pharmaceuticals Corp. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0641-9219_dc27760d-6f90-470c-9e81-34a0bbf4bb97 0641-9219 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20081217 ANDA ANDA078538 West-Ward Pharmaceuticals Corp. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0642-0070_e6535f53-9b25-48ed-817f-9dc637598612 0642-0070 HUMAN PRESCRIPTION DRUG Vitafol One Prenatal Supplement with DHA CAPSULE, GELATIN COATED ORAL 20110613 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; IODINE; MAGNESIUM; ZINC; COPPER; VITAMIN D; OMEGA-3 FATTY ACIDS; VITAMIN E; IRON 1100; 30; 1.6; 1.8; 15; 2.5; .012; 1; .15; 20; 25; 2; 1000; 200; 20; 29 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 0642-0072_667440e5-a115-41f7-91a7-8acf0edc115f 0642-0072 HUMAN PRESCRIPTION DRUG Vitafol Caplet Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, and Iron CAPSULE ORAL 19850501 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM; IRON 6000; 60; 400; 10; 1.1; 1.8; 15; 15; 1; 5; 125; 27 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] E 20171231 0642-0075_1fb44ddb-b983-4153-b015-3b0bf7a3dfde 0642-0075 HUMAN PRESCRIPTION DRUG Select-OB Plus DHA Prenatal Supplement Plus DHA .BETA.-CAROTENE, VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, Thiamine Mononitrate, Riboflavin, NIACINAMIDE, Pyridoxine Hydrochloride, Folic Acid, LEVOMEFOLATE CALCIUM, Cobalamin, Iron, MAGNESIUM OXIDE, ZINC OXIDE, and DOCONEXANT KIT 20090408 UNAPPROVED DRUG OTHER Exeltis USA, Inc. N 20181231 0642-0076_5475e78f-94ac-4e4f-8553-7636abd4a7b5 0642-0076 HUMAN PRESCRIPTION DRUG Vitafol-OB Plus DHA Prenatal Supplement Plus DHA Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, Copper, and Doconexent KIT 20070216 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. N 20181231 0642-0077_9a1a22a6-f13d-46fb-bde3-c2372feebddb 0642-0077 HUMAN PRESCRIPTION DRUG Select OB .Beta.-Carotene, VITAMIN A ACETATE, Ascorbic Acid, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, LEVOMEFOLATE CALCIUM, Cobalamin, Iron, Magnesium, and Zinc TABLET, CHEWABLE ORAL 20051004 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. .BETA.-CAROTENE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM; COBALAMIN; IRON; MAGNESIUM; ZINC 600; 1100; 60; 400; 30; 1.6; 1.8; 15; 2.5; .4; .6; 5; 29; 25; 15 [iU]/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 0642-0079_92aec517-af55-4c0f-ae74-34fd7e414e54 0642-0079 HUMAN PRESCRIPTION DRUG Vitafol OB Caplet Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium, Iron, Magnesium, Zinc, and Copper TABLET ORAL 20021202 UNAPPROVED DRUG OTHER Exeltis USA, Inc. VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM; IRON; MAGNESIUM; ZINC; COPPER 2700; 70; 400; 30; 1.6; 1.8; 18; 2.5; 1; 12; 100; 65; 25; 25; 2 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] N 20181231 0642-0092_bb1edb09-09b6-48dc-9acb-1592639035e6 0642-0092 HUMAN PRESCRIPTION DRUG Vitafol Plus Omega-3 Fatty Acids, Niacin, .Alpha.-Tocopherol, Vitamin D, Lauric Acid, Vitamin A, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc, Copper, Iodine, Magnesium, and Folic Acid CAPSULE, LIQUID FILLED ORAL 20120423 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. OMEGA-3 FATTY ACIDS; NIACIN; .ALPHA.-TOCOPHEROL; VITAMIN D; LAURIC ACID; VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC; COPPER; IODINE; MAGNESIUM; FOLIC ACID 200; 15; 10; 1000; 60; 1100; 12; 1.6; 1.8; 2.5; 12; 27; 15; 2; 200; 5; 1 mg/1; mg/1; [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 0642-0093_042a594f-b2d4-4381-bdcb-ddcb9b34eda0 0642-0093 HUMAN PRESCRIPTION DRUG Vitafol Ultra Doconexent, Niacinamide, .Alpha.-Tocopherol Acetate, DL-, Cholecalciferol, .Beta.-Carotene, Ascorbic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Iron, Zinc Oxide, Cupric Oxide, Potassium Iodide, Magnesium Oxide, Folic Acid, and Levomefolate Calcium CAPSULE, LIQUID FILLED ORAL 20130923 UNAPPROVED DRUG OTHER Exeltis USA, Inc. DOCONEXENT; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; CHOLECALCIFEROL; .BETA.-CAROTENE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON; ZINC OXIDE; CUPRIC OXIDE; POTASSIUM IODIDE; MAGNESIUM OXIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM 200; 15; 20; 1000; 1100; 30; 1.6; 1.8; 2.5; 12; 29; 25; 2; 150; 20; .4; .6 mg/1; mg/1; [iU]/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0642-0094_5a2ce476-27d7-421b-932b-a401f0fb9e22 0642-0094 HUMAN PRESCRIPTION DRUG Vitafol Nano CHOLECALCIFEROL, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, and Iodine TABLET, COATED ORAL 20140714 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; IRON; IODINE 1000; 2.5; .4; .6; 12; 18; 150 [iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 0642-0096_0b5e21c3-371b-409d-ba8a-0cf85f69d242 0642-0096 HUMAN PRESCRIPTION DRUG Vitafol Fe Plus Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Iodine, Iron, Magnesium, Zinc, Copper, Doconexent, and Docusate Sodium KIT 20151001 UNAPPROVED DRUG OTHER Exeltis USA, Inc. N 20181231 0642-0096_5ef6b2b5-a915-4328-b59d-cdf523207b22 0642-0096 HUMAN PRESCRIPTION DRUG Vitafol Fe Plus Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Iodine, Iron, Magnesium, Zinc, Copper, Doconexent, and Docusate Sodium KIT 20151001 UNAPPROVED DRUG OTHER Exeltis USA, Inc. N 20181231 0642-0120_13fcc1c1-c176-4500-937e-be35b285c7c8 0642-0120 HUMAN PRESCRIPTION DRUG Select OB .BETA.-CAROTENE, VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, COBALAMIN, IRON, MAGNESIUM OXIDE, and ZINC OXIDE TABLET, CHEWABLE ORAL 20140714 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. .BETA.-CAROTENE; VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM; COBALAMIN; IRON; MAGNESIUM OXIDE; ZINC OXIDE 600; 1100; 60; 400; 30; 1.6; 1.8; 15; 2.5; .4; .6; 5; 29; 25; 15 [iU]/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 0642-0204_13d4ddf2-f701-441b-87d6-010bc26f677d 0642-0204 HUMAN PRESCRIPTION DRUG Strovite Forte Caplet Vitamin A, Ascorbic Acid, Vitamin D, .Alpha.-Tocopherol, Thiamine Mononitrate, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Biotin, Pantothenic Acid, Magnesium, Zinc, Selenium, Copper, Chromium, Molybdenum, and Iron TABLET, COATED ORAL 19961001 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; MAGNESIUM; ZINC; SELENIUM; COPPER; CHROMIUM; MOLYBDENUM; IRON 4000; 500; 400; 60; 20; 20; 100; 25; 1; 50; .15; 25; 50; 15; 50; 3; 50; 20; 10 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 0642-0207_754ade54-910c-4419-9887-c63a63efeb47 0642-0207 HUMAN PRESCRIPTION DRUG Strovite One Caplets Vitamin A, Calcium Pantothenate, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Succinate, D-, Thiamine, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Biotin, Cyanocobalamin, Selenium, Magnesium Oxide, Zinc Oxide, Cupric Sulfate, Manganese, Chromium, .Alpha.-Lipoic Acid, and Lutein TABLET ORAL 20010504 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. VITAMIN A; CALCIUM PANTOTHENATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN; SELENIUM; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC SULFATE; MANGANESE; CHROMIUM; .ALPHA.-LIPOIC ACID; LUTEIN 3000; 15; 300; 1000; 100; 20; 5; 25; 25; 1; 100; 50; 100; 50; 25; 1.5; 1.5; 50; 15; 5 [iU]/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 0642-3010_37359587-129b-461f-a82f-b4461eeff080 0642-3010 HUMAN PRESCRIPTION DRUG Reaphirm Plant Source DHA Prenatal Supplement CAPSULE, GELATIN COATED ORAL 20111205 UNAPPROVED DRUG OTHER Everett Laboratories, Inc. VITAMIN A; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; IODINE; MAGNESIUM; ZINC; COPPER; VITAMIN D; OMEGA-3 FATTY ACIDS; VITAMIN E; IRON 1100; 30; 1.6; 1.8; 15; 2.5; .012; 1; .15; 20; 25; 2; 1000; 200; 20; 29 [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 0642-7463_c03407a0-762a-4ee3-b0db-bd5f93ceb08c 0642-7463 HUMAN PRESCRIPTION DRUG Benznidazole benznidazole TABLET ORAL 20171229 NDA NDA209570 Exeltis USA, Inc. BENZNIDAZOLE 12.5 mg/1 N 20181231 0642-7464_c03407a0-762a-4ee3-b0db-bd5f93ceb08c 0642-7464 HUMAN PRESCRIPTION DRUG Benznidazole benznidazole TABLET ORAL 20171229 NDA NDA209570 Exeltis USA, Inc. BENZNIDAZOLE 100 mg/1 N 20181231 0677-1978_64a32a66-e695-4fa9-b0e3-df33d91ffc4f 0677-1978 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090901 NDA AUTHORIZED GENERIC NDA020356 United Research Laboratories, Inc. NISOLDIPINE 8.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] E 20171231 0677-1979_64a32a66-e695-4fa9-b0e3-df33d91ffc4f 0677-1979 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090901 NDA AUTHORIZED GENERIC NDA020356 United Research Laboratories, Inc. NISOLDIPINE 17 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] E 20171231 0677-1980_64a32a66-e695-4fa9-b0e3-df33d91ffc4f 0677-1980 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090901 NDA AUTHORIZED GENERIC NDA020356 United Research Laboratories, Inc. NISOLDIPINE 25.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] E 20171231 0677-1981_64a32a66-e695-4fa9-b0e3-df33d91ffc4f 0677-1981 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090901 NDA AUTHORIZED GENERIC NDA020356 United Research Laboratories, Inc. NISOLDIPINE 34 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] E 20171231 0682-0334_205a4d78-8faa-4feb-a3aa-d014aeccf92c 0682-0334 HUMAN PRESCRIPTION DRUG Urimar-T Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate TABLET ORAL 20050722 UNAPPROVED DRUG OTHER Marnel Pharmaceuticals, LLC METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE 120; 40.8; 36.2; 10.8; .12 mg/1; mg/1; mg/1; mg/1; mg/1 Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 0682-0475_53bf9e22-efac-41bd-aed4-5f01ba9244b3 0682-0475 HUMAN OTC DRUG MAR-COF CG Expectorant CODEINE PHOSPHATE and GUAIFENESIN SYRUP ORAL 20081201 OTC MONOGRAPH FINAL part341 Marnel Pharmaceuticals, LLC CODEINE PHOSPHATE; GUAIFENESIN 7.5; 225 mg/5mL; mg/5mL CV N 20181231 0682-0480_11f3111b-84c1-4f5a-8257-d36ef7cca2c0 0682-0480 HUMAN OTC DRUG Mar-cof BP BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, and PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP ORAL 20091001 OTC MONOGRAPH FINAL part341 Marnel Pharmaceutcals, Inc. BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 7.5; 30 mg/5mL; mg/5mL; mg/5mL CV E 20171231 0682-0804_45e5829d-8800-4cff-8c5b-c881c2a9db39 0682-0804 HUMAN PRESCRIPTION DRUG Margesic butalbital, acetaminophen and caffeine CAPSULE ORAL 19940601 ANDA ANDA089007 Marnel Pharmaceuticals, LLC BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0682-1570_127a3123-c560-4dc6-bebf-8a5d71f73880 0682-1570 HUMAN PRESCRIPTION DRUG Marnatal F ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON SUCROSE, MAGNESIUM OXIDE, and CUPRIC OXIDE CAPSULE ORAL 20100108 UNAPPROVED DRUG OTHER Marnel Pharmaceuticals, Inc. ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; IRON SUCROSE; MAGNESIUM OXIDE; CUPRIC OXIDE 100; 400; 30; 3; 3.4; 20; 5; 1000; 12; 150; 60; 25; 2 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 0682-3001_ed775d39-46ec-4014-a727-232ab02b6f10 0682-3001 HUMAN PRESCRIPTION DRUG BACMIN VITAMIN A ACETATE, .ALPHA.-TOCOPHEROL ACETATE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, BIOTIN, CALCIUM PANTOTHENATE, FOLIC ACID, CYANOCOBALAMIN, FLAVONE, FERROUS FUMARATE, CHROMIC CHLORIDE CR-51, MAGNESIUM OXIDE, MANGANESE GLUCONATE, CUPRIC OXIDE, SELENOMETHIONINE, and ZINC OXIDE TABLET, COATED ORAL 20000401 UNAPPROVED DRUG OTHER Marnel Pharmaceuticals, Inc. VITAMIN A ACETATE; .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; BIOTIN; CALCIUM PANTOTHENATE; FOLIC ACID; CYANOCOBALAMIN; FLAVONE; FERROUS FUMARATE; CHROMIC CHLORIDE CR-51; MAGNESIUM OXIDE; MANGANESE GLUCONATE; CUPRIC OXIDE; SELENOMETHIONINE; ZINC OXIDE 2000; 30; 500; 20; 20; 100; 25; 150; 25; 1; 50; 50; 27; .1; 50; 5; 3; 50; 22.5 [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 0699-0001_b2917c26-a3fc-48a9-b5f0-1d62fe15af74 0699-0001 HUMAN PRESCRIPTION DRUG Formo Cresol Cresol LIQUID DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare CRESOL 485 mg/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] E 20171231 0699-0150_60dca200-d978-5662-e053-2991aa0ade04 0699-0150 HUMAN PRESCRIPTION DRUG Topex 60 Second Fluoride Foam Strawberry sodium fluoride AEROSOL, FOAM DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" SODIUM FLUORIDE 27.3 mg/g N 20181231 0699-0151_60dca200-d978-5662-e053-2991aa0ade04 0699-0151 HUMAN PRESCRIPTION DRUG Topex 60 Second Fluoride Foam Spearmint sodium fluoride AEROSOL, FOAM DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" SODIUM FLUORIDE 27.3 mg/g N 20181231 0699-0152_60dca200-d978-5662-e053-2991aa0ade04 0699-0152 HUMAN PRESCRIPTION DRUG Topex 60 Second Fluoride Foam Bubble Fun sodium fluoride AEROSOL, FOAM DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" SODIUM FLUORIDE 27.3 mg/g N 20181231 0699-0153_60dca200-d978-5662-e053-2991aa0ade04 0699-0153 HUMAN PRESCRIPTION DRUG Topex 60 Second Fluoride Foam Grape sodium fluoride AEROSOL, FOAM DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" SODIUM FLUORIDE 27.3 mg/g N 20181231 0699-0154_60dca200-d978-5662-e053-2991aa0ade04 0699-0154 HUMAN PRESCRIPTION DRUG Topex 60 Second Fluoride Foam Orange Cream sodium fluoride AEROSOL, FOAM DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" SODIUM FLUORIDE 27.3 mg/g N 20181231 0699-0155_60f08fe4-aacf-c815-e053-2991aa0a3ded 0699-0155 HUMAN PRESCRIPTION DRUG Topex Neutral Fluoride Foam sodium fluoride AEROSOL, FOAM DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" SODIUM FLUORIDE .02 g/g N 20181231 0699-0203_609f8926-f3c3-ad52-e053-2991aa0adedd 0699-0203 HUMAN PRESCRIPTION DRUG Buckleys Formo Cresol Cresol LIQUID DENTAL 19630219 UNAPPROVED DRUG OTHER Dentsply LLC, Professional Division Trading as "Sultan Healthcare" CRESOL 350 mg/g N 20181231 0699-0311_59039cf6-9008-7367-e053-2a91aa0a2fe9 0699-0311 HUMAN PRESCRIPTION DRUG Topex 60 Second Fluoride Gel Sodium Fluoride GEL DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" SODIUM FLUORIDE 25.9 mg/g N 20181231 0699-0312_59039cf6-9008-7367-e053-2a91aa0a2fe9 0699-0312 HUMAN PRESCRIPTION DRUG Topex 60 Second Fluoride Gel Sodium Fluoride GEL DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" SODIUM FLUORIDE 25.9 mg/g N 20181231 0699-0317_59039cf6-9008-7367-e053-2a91aa0a2fe9 0699-0317 HUMAN PRESCRIPTION DRUG Topex 60 Second Fluoride Gel Sodium Fluoride GEL DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" SODIUM FLUORIDE 25.9 mg/g N 20181231 0699-0404_5bc1c974-e7b8-094c-e053-2991aa0ab726 0699-0404 HUMAN PRESCRIPTION DRUG Dry Socket Guaiacol and Eugenol PASTE DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC, Professional Division, trading as "Sultan Healthcare" GUAIACOL; EUGENOL .0416; .0416 g/g; g/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-0412_b2917c26-a3fc-48a9-b5f0-1d62fe15af74 0699-0412 HUMAN PRESCRIPTION DRUG Formo Cresol Cresol LIQUID DENTAL 19630219 UNAPPROVED DRUG OTHER DSHealthcare CRESOL 485 mg/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] E 20171231 0699-0701_60ccbdf2-9441-3f1e-e053-2a91aa0ac993 0699-0701 HUMAN PRESCRIPTION DRUG Topex Neutral pH Fluoride Gel Mint sodium fluoride GEL DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" FLUORIDE ION 9 mg/g N 20181231 0699-0702_60ccbdf2-9441-3f1e-e053-2a91aa0ac993 0699-0702 HUMAN PRESCRIPTION DRUG Topex Neutral pH Fluoride Gel Strawberry sodium fluoride GEL DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" FLUORIDE ION 9 mg/g N 20181231 0699-0957_b9b49f4f-db22-44ae-b199-be45bb33c142 0699-0957 HUMAN OTC DRUG InstaFresh Alcohol LIQUID TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part333A DSHealthcare ALCOHOL 70 mL/100mL N 20181231 0699-1081_609f3d0c-89a5-06b5-e053-2991aa0a87a1 0699-1081 HUMAN PRESCRIPTION DRUG Hemoban Aluminum Chloride SOLUTION DENTAL 19630219 UNAPPROVED DRUG OTHER Dentsply LLC, Professional Division Trading as "Sultan Healthcare" ALUMINUM CHLORIDE ANHYDROUS 250 mg/g N 20181231 0699-3100_60c87af2-1dc6-2daf-e053-2a91aa0a7555 0699-3100 HUMAN PRESCRIPTION DRUG Topex benzocaine SPRAY, METERED PERIODONTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-3111_60cbe11b-eefd-448a-e053-2991aa0a2d09 0699-3111 HUMAN PRESCRIPTION DRUG Topex Cherry benzocaine GEL DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-3112_60cbe11b-eefd-448a-e053-2991aa0a2d09 0699-3112 HUMAN PRESCRIPTION DRUG Topex Pina Colada benzocaine GEL DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-5720_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5720 HUMAN OTC DRUG Moist SURE Triclosan LIQUID TOPICAL 20060306 OTC MONOGRAPH FINAL part333E DSHealthcare TRICLOSAN 7.5 mg/g N 20181231 0699-5725_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5725 HUMAN OTC DRUG Moist SURE Triclosan LIQUID TOPICAL 19920102 OTC MONOGRAPH FINAL part333E DSHealthcare TRICLOSAN 5 mg/g E 20171231 0699-5726_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5726 HUMAN OTC DRUG Moist SURE Triclosan LIQUID TOPICAL 19920102 OTC MONOGRAPH FINAL part333E DSHealthcare TRICLOSAN 5 mg/g N 20181231 0699-5727_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5727 HUMAN OTC DRUG Moist SURE Triclosan LIQUID TOPICAL 19920102 OTC MONOGRAPH FINAL part333E DSHealthcare TRICLOSAN 5 mg/g N 20181231 0699-5728_5bc1cc32-5d02-00a8-e053-2991aa0a0c81 0699-5728 HUMAN OTC DRUG Moist SURE Triclosan LIQUID TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part333E DENTSPLY LLC, Professional Division trading as Sultan Healthcare TRICLOSAN 5 g/L N 20181231 0699-5740_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5740 HUMAN OTC DRUG Moist SURE Isopropyl Alcohol LIQUID TOPICAL 20040501 OTC MONOGRAPH FINAL part333E DSHealthcare ISOPROPYL ALCOHOL 630 mg/g E 20171231 0699-5741_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5741 HUMAN OTC DRUG Moist SURE Isopropyl Alcohol LIQUID TOPICAL 20040501 OTC MONOGRAPH FINAL part333E DSHealthcare ISOPROPYL ALCOHOL 630 mg/g N 20181231 0699-5742_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5742 HUMAN OTC DRUG Moist SURE Isopropyl Alcohol LIQUID TOPICAL 20040501 OTC MONOGRAPH FINAL part333E DSHealthcare ISOPROPYL ALCOHOL 630 mg/g N 20181231 0699-5743_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5743 HUMAN OTC DRUG Moist SURE Isopropyl Alcohol LIQUID TOPICAL 20040501 OTC MONOGRAPH FINAL part333E DSHealthcare ISOPROPYL ALCOHOL 630 mg/g E 20171231 0699-5750_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5750 HUMAN OTC DRUG Moist SURE Alcohol LIQUID TOPICAL 19880102 OTC MONOGRAPH FINAL part333E DSHealthcare ALCOHOL 620 mg/g E 20171231 0699-5751_b7869a5e-318b-4189-a3ba-773d9b068969 0699-5751 HUMAN OTC DRUG Moist SURE Alcohol LIQUID TOPICAL 19880102 OTC MONOGRAPH FINAL part333E DSHealthcare ALCOHOL 620 mg/g N 20181231 0699-7001_60a45d64-acb5-f579-e053-2991aa0aacb4 0699-7001 HUMAN PRESCRIPTION DRUG Topex Pina Colada Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-7011_60a45d64-acb5-f579-e053-2991aa0aacb4 0699-7011 HUMAN PRESCRIPTION DRUG Topex Mint Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-7021_60a45d64-acb5-f579-e053-2991aa0aacb4 0699-7021 HUMAN PRESCRIPTION DRUG Topex Cherry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-7031_60a45d64-acb5-f579-e053-2991aa0aacb4 0699-7031 HUMAN PRESCRIPTION DRUG Topex Bubble Gum Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-7051_60a45d64-acb5-f579-e053-2991aa0aacb4 0699-7051 HUMAN PRESCRIPTION DRUG Topex Strawberry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-7061_60a45d64-acb5-f579-e053-2991aa0aacb4 0699-7061 HUMAN PRESCRIPTION DRUG Topex Raspberry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-7071_60a45d64-acb5-f579-e053-2991aa0aacb4 0699-7071 HUMAN PRESCRIPTION DRUG Topex Cherry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-7081_60a45d64-acb5-f579-e053-2991aa0aacb4 0699-7081 HUMAN PRESCRIPTION DRUG Topex Mint Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-7091_60a45d64-acb5-f579-e053-2991aa0aacb4 0699-7091 HUMAN PRESCRIPTION DRUG Topex Pina Colada Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0699-7100_60a45d64-acb5-f579-e053-2991aa0aacb4 0699-7100 HUMAN PRESCRIPTION DRUG Topex Bubble Gum Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "Sultan Healthcare" BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 0703-0018_eb089bca-81d7-4c69-aefd-b50c7de724a4 0703-0018 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110118 ANDA ANDA078591 Teva Parenteral Medicines, Inc. HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0703-0020_5052f4ca-c297-4fc4-85b1-821351875c20 0703-0020 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION, SOLUTION INTRAVENOUS 20150427 NDA NDA206769 Teva Parenteral Medicines, Inc. ARGATROBAN 1 mg/mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 0703-0031_83734c44-eaf9-4393-915c-07a5adbcb7f2 0703-0031 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20050308 ANDA ANDA040557 Teva Parenteral Medicines, Inc. METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0703-0043_5b4f3ede-6b2c-406a-9fb2-138c75aaeef1 0703-0043 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 20061031 ANDA ANDA040620 Teva Parenteral Medicines, Inc. METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0703-0045_5b4f3ede-6b2c-406a-9fb2-138c75aaeef1 0703-0045 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 20061031 ANDA ANDA040620 Teva Parenteral Medicines, Inc. METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0703-0051_83734c44-eaf9-4393-915c-07a5adbcb7f2 0703-0051 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20050308 ANDA ANDA040557 Teva Parenteral Medicines, Inc. METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0703-0063_5b4f3ede-6b2c-406a-9fb2-138c75aaeef1 0703-0063 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 20061031 ANDA ANDA040620 Teva Parenteral Medicines, Inc. METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0703-0110_eb089bca-81d7-4c69-aefd-b50c7de724a4 0703-0110 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110118 ANDA ANDA078591 Teva Parenteral Medicines, Inc. HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0703-0113_eb089bca-81d7-4c69-aefd-b50c7de724a4 0703-0113 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110118 ANDA ANDA078591 Teva Parenteral Medicines, Inc. HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0703-0125_15a46a51-6c09-47d9-a62a-c7512766e717 0703-0125 HUMAN PRESCRIPTION DRUG Daptomycin Daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160615 NDA AUTHORIZED GENERIC NDA021572 Teva Parenteral Medicines, Inc. DAPTOMYCIN 500 mg/10mL Lipopeptide Antibacterial [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 0703-1153_7a8a77f9-3a9d-4cec-ab9b-dc7aa16645a9 0703-1153 HUMAN PRESCRIPTION DRUG Norepinephrine Bitartrate Norepinephrine Bitartrate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20030401 ANDA ANDA040455 Teva Parenteral Medicines, Inc. NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 0703-1165_bd9c2668-0e91-44b2-8205-bdd8f82fa5c3 0703-1165 HUMAN PRESCRIPTION DRUG Eptifibatide Eptifibatide INJECTION, SOLUTION INTRAVENOUS 20160706 ANDA ANDA090854 Teva Parenteral Medicines, Inc. EPTIFIBATIDE 2 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0703-1179_e147e52b-0a2c-4669-aeca-175f4d7028a6 0703-1179 HUMAN PRESCRIPTION DRUG Eptifibatide Eptifibatide INJECTION, SOLUTION INTRAVENOUS 20151214 ANDA ANDA091555 Teva Parenteral Medicines, Inc. EPTIFIBATIDE .75 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 0703-1501_aff8c1fa-b88c-449f-af23-896d74fcdeb2 0703-1501 HUMAN PRESCRIPTION DRUG Alprostadil Alprostadil INJECTION, SOLUTION, CONCENTRATE INTRAVASCULAR 19990430 ANDA ANDA075196 Teva Parenteral Medicines, Inc. ALPROSTADIL 500 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 0703-1985_45b8b475-ff2a-40c1-b330-0db3934d3e43 0703-1985 HUMAN PRESCRIPTION DRUG Epoprostenol Sodium Epoprostenol Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080423 ANDA ANDA078396 Teva Parenteral Medicines, Inc. EPOPROSTENOL SODIUM .5 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 0703-1995_45b8b475-ff2a-40c1-b330-0db3934d3e43 0703-1995 HUMAN PRESCRIPTION DRUG Epoprostenol Sodium Epoprostenol Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080423 ANDA ANDA078396 Teva Parenteral Medicines, Inc. EPOPROSTENOL SODIUM 1.5 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 0703-2394_5f3aa05d-26c6-48fc-9a2c-dc0118d020a4 0703-2394 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20081201 ANDA ANDA078717 Teva Parenteral Medicines, Inc. ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0703-2395_5f3aa05d-26c6-48fc-9a2c-dc0118d020a4 0703-2395 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20081201 ANDA ANDA078717 Teva Parenteral Medicines, Inc. ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0703-2914_811bb1bf-9798-40c0-ad9e-560bbbe6ae28 0703-2914 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20021114 ANDA ANDA074688 Teva Parenteral Medicines, Inc. VECURONIUM BROMIDE 10 mg/10mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0703-2925_811bb1bf-9798-40c0-ad9e-560bbbe6ae28 0703-2925 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20021114 ANDA ANDA074688 Teva Parenteral Medicines, Inc. VECURONIUM BROMIDE 20 mg/20mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0703-3015_45d40871-0880-4995-83a4-14355bb7833f 0703-3015 HUMAN PRESCRIPTION DRUG Adrucil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20031001 ANDA ANDA040333 Teva Parenteral Medicines, Inc. FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0703-3018_467a0319-3bcf-457d-9170-ff78516b81bd 0703-3018 HUMAN PRESCRIPTION DRUG Adrucil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20031001 ANDA ANDA040334 Teva Parenteral Medicines, Inc. FLUOROURACIL 2.5 g/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0703-3019_467a0319-3bcf-457d-9170-ff78516b81bd 0703-3019 HUMAN PRESCRIPTION DRUG Adrucil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20031001 ANDA ANDA040334 Teva Parenteral Medicines, Inc. FLUOROURACIL 5 g/100mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0703-3154_936bdb17-3077-4f45-af03-7d1fc331e258 0703-3154 HUMAN PRESCRIPTION DRUG Bleomycin Bleomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20000630 ANDA ANDA065033 Teva Parenteral Medicines, Inc. BLEOMYCIN SULFATE 15 [USP'U]/1 Cytoprotective Agent [EPC] N 20181231 0703-3155_936bdb17-3077-4f45-af03-7d1fc331e258 0703-3155 HUMAN PRESCRIPTION DRUG Bleomycin Bleomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20000630 ANDA ANDA065033 Teva Parenteral Medicines, Inc. BLEOMYCIN SULFATE 30 [USP'U]/1 Cytoprotective Agent [EPC] N 20181231 0703-3301_bfb154d8-b9fc-4a06-9f79-d5f3ee882fd7 0703-3301 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20051114 ANDA ANDA075957 Teva Parenteral Medicines, Inc. OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0703-3311_bfb154d8-b9fc-4a06-9f79-d5f3ee882fd7 0703-3311 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20051114 ANDA ANDA075957 Teva Parenteral Medicines, Inc. OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0703-3321_bfb154d8-b9fc-4a06-9f79-d5f3ee882fd7 0703-3321 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20051114 ANDA ANDA075957 Teva Parenteral Medicines, Inc. OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0703-3333_bfb154d8-b9fc-4a06-9f79-d5f3ee882fd7 0703-3333 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20051123 ANDA ANDA075959 Teva Parenteral Medicines, Inc. OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0703-3343_bfb154d8-b9fc-4a06-9f79-d5f3ee882fd7 0703-3343 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20051123 ANDA ANDA075959 Teva Parenteral Medicines, Inc. OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0703-3427_1d6d2ca3-4792-470a-9576-752720b32a7c 0703-3427 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION, SOLUTION INTRAVENOUS 20070726 ANDA ANDA076657 Teva Parenteral Medicines, Inc. IFOSFAMIDE 1 g/20mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0703-3429_1d6d2ca3-4792-470a-9576-752720b32a7c 0703-3429 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION, SOLUTION INTRAVENOUS 20070726 ANDA ANDA076657 Teva Parenteral Medicines, Inc. IFOSFAMIDE 3 g/60mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0703-3671_327342db-3929-4db7-9b2a-b5f966e84974 0703-3671 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20130130 ANDA ANDA040843 Teva Parenteral Medicines, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20191231 0703-3671_5e02ac37-77ac-4221-b99e-2a976c593fc3 0703-3671 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120731 ANDA ANDA040843 Teva Parenteral Medicines, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20191231 0703-3675_327342db-3929-4db7-9b2a-b5f966e84974 0703-3675 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20130130 ANDA ANDA040843 Teva Parenteral Medicines, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20191231 0703-3675_5e02ac37-77ac-4221-b99e-2a976c593fc3 0703-3675 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120801 ANDA ANDA040843 Teva Parenteral Medicines, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20191231 0703-3678_5e02ac37-77ac-4221-b99e-2a976c593fc3 0703-3678 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120801 ANDA ANDA040843 Teva Parenteral Medicines, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20191231 0703-3678_e58a6c2c-e26d-490b-abc2-83a198e0c126 0703-3678 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20151214 ANDA ANDA040843 Teva Parenteral Medicines, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20191231 0703-3985_6f8583cd-b0e9-4b2b-8739-158760ff0559 0703-3985 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090811 NDA NDA022160 Teva Parenteral Medicines, Inc. OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-3986_6f8583cd-b0e9-4b2b-8739-158760ff0559 0703-3986 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090811 NDA NDA022160 Teva Parenteral Medicines, Inc. OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-4075_9e58ba7b-c5fa-4e1f-8920-38e5cf1bcea8 0703-4075 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20020401 ANDA ANDA076153 Teva Parenteral Medicines, Inc. PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0703-4085_9e58ba7b-c5fa-4e1f-8920-38e5cf1bcea8 0703-4085 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, SOLUTION INTRAVENOUS 20020401 ANDA ANDA076153 Teva Parenteral Medicines, Inc. PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 0703-4154_903278ff-4613-4b29-9b22-97bbe312ecbd 0703-4154 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20021001 ANDA ANDA065036 Teva Parenteral Medicines, Inc. IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0703-4155_903278ff-4613-4b29-9b22-97bbe312ecbd 0703-4155 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20021001 ANDA ANDA065036 Teva Parenteral Medicines, Inc. IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0703-4156_903278ff-4613-4b29-9b22-97bbe312ecbd 0703-4156 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20021001 ANDA ANDA065036 Teva Parenteral Medicines, Inc. IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0703-4239_73460167-8005-4ffc-a885-d7b57c173317 0703-4239 HUMAN PRESCRIPTION DRUG CARBOplatin CARBOplatin INJECTION, SOLUTION INTRAVENOUS 20141023 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-4239_9579cc9e-f4a2-471f-a405-4a209b517b5e 0703-4239 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20160119 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-4244_73460167-8005-4ffc-a885-d7b57c173317 0703-4244 HUMAN PRESCRIPTION DRUG CARBOplatin CARBOplatin INJECTION, SOLUTION INTRAVENOUS 20060504 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-4244_9579cc9e-f4a2-471f-a405-4a209b517b5e 0703-4244 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20160115 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-4246_73460167-8005-4ffc-a885-d7b57c173317 0703-4246 HUMAN PRESCRIPTION DRUG CARBOplatin CARBOplatin INJECTION, SOLUTION INTRAVENOUS 20060501 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-4246_9579cc9e-f4a2-471f-a405-4a209b517b5e 0703-4246 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20151125 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-4248_73460167-8005-4ffc-a885-d7b57c173317 0703-4248 HUMAN PRESCRIPTION DRUG CARBOplatin CARBOplatin INJECTION, SOLUTION INTRAVENOUS 20060201 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-4248_9579cc9e-f4a2-471f-a405-4a209b517b5e 0703-4248 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20151209 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-4248_e6104a65-f20b-4e99-9119-0960fa812904 0703-4248 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20150604 ANDA ANDA077269 Teva Parenteral Medicines, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-4402_4d1d8a60-ce2e-412b-a814-b033382bccc1 0703-4402 HUMAN PRESCRIPTION DRUG Vincasar PFS vinCRIStine sulfate INJECTION, SOLUTION INTRAVENOUS 20000501 ANDA ANDA075493 Teva Parenteral Medicines, Inc. VINCRISTINE SULFATE 1 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] N 20181231 0703-4412_4d1d8a60-ce2e-412b-a814-b033382bccc1 0703-4412 HUMAN PRESCRIPTION DRUG Vincasar PFS vinCRIStine sulfate INJECTION, SOLUTION INTRAVENOUS 20000501 ANDA ANDA075493 Teva Parenteral Medicines, Inc. VINCRISTINE SULFATE 1 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] N 20181231 0703-4432_1f9a3c6d-91bd-4862-a27c-ecc1f10426b6 0703-4432 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20150701 ANDA ANDA090101 Teva Parenteral Medicines, Inc. IRINOTECAN HYDROCHLORIDE 40 mg/2mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0703-4432_7527ea3d-bc76-468f-beff-d141a57ecf37 0703-4432 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20080228 ANDA ANDA090101 Teva Parenteral Medicines, Inc. IRINOTECAN HYDROCHLORIDE 40 mg/2mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0703-4434_1f9a3c6d-91bd-4862-a27c-ecc1f10426b6 0703-4434 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20150701 ANDA ANDA090101 Teva Parenteral Medicines, Inc. IRINOTECAN HYDROCHLORIDE 100 mg/5mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0703-4434_7527ea3d-bc76-468f-beff-d141a57ecf37 0703-4434 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20080227 ANDA ANDA090101 Teva Parenteral Medicines, Inc. IRINOTECAN HYDROCHLORIDE 100 mg/5mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0703-4502_191cdc9f-5d64-4e25-a0a1-a66327a87bc1 0703-4502 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19911201 ANDA ANDA073135 Teva Parenteral Medicines, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0703-4502_8df9be0c-2efb-449e-a82b-ed4b1abf7ed3 0703-4502 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150209 ANDA ANDA073135 Teva Parenteral Medicines, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0703-4502_f18e7463-4497-4d0a-a6f9-c272cba6600c 0703-4502 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150817 ANDA ANDA073135 Teva Parenteral Medicines, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 0703-4636_3ea01059-8c39-431c-a1c4-c03315b083e1 0703-4636 HUMAN PRESCRIPTION DRUG Zanosar streptozocin POWDER, FOR SOLUTION INTRAVENOUS 20031203 NDA NDA050577 Teva Parenteral Medicines, Inc. STREPTOZOCIN 100 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0703-4680_ee1455df-d7a3-448a-86d4-8f28c910a09b 0703-4680 HUMAN PRESCRIPTION DRUG mitoXANTRONE mitoXANTRONE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060411 ANDA ANDA077356 Teva Parenteral Medicines, Inc. MITOXANTRONE HYDROCHLORIDE 2 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0703-4685_ee1455df-d7a3-448a-86d4-8f28c910a09b 0703-4685 HUMAN PRESCRIPTION DRUG mitoXANTRONE mitoXANTRONE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060411 ANDA ANDA077356 Teva Parenteral Medicines, Inc. MITOXANTRONE HYDROCHLORIDE 2 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0703-4686_ee1455df-d7a3-448a-86d4-8f28c910a09b 0703-4686 HUMAN PRESCRIPTION DRUG mitoXANTRONE mitoXANTRONE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060411 ANDA ANDA077356 Teva Parenteral Medicines, Inc. MITOXANTRONE HYDROCHLORIDE 2 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0703-4714_ae304685-a4f5-43fe-8ea1-84ccd123b5c5 0703-4714 HUMAN PRESCRIPTION DRUG Topotecan Topotecan INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130521 NDA NDA022453 Teva Parenteral Medicines, Inc. TOPOTECAN HYDROCHLORIDE 1 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20191231 0703-4764_4cb4199b-9340-4cf9-a271-be7233cb2803 0703-4764 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160303 ANDA ANDA075184 Teva Parenteral Medicines, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0703-4764_8e059cef-4e91-4995-9485-2349cf8a29a1 0703-4764 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20091103 ANDA ANDA075184 Teva Parenteral Medicines, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0703-4766_4cb4199b-9340-4cf9-a271-be7233cb2803 0703-4766 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160303 ANDA ANDA075184 Teva Parenteral Medicines, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0703-4766_8e059cef-4e91-4995-9485-2349cf8a29a1 0703-4766 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20080924 ANDA ANDA075184 Teva Parenteral Medicines, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0703-4767_8e059cef-4e91-4995-9485-2349cf8a29a1 0703-4767 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20081023 ANDA ANDA075184 Teva Parenteral Medicines, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0703-4768_4cb4199b-9340-4cf9-a271-be7233cb2803 0703-4768 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160303 ANDA ANDA075184 Teva Parenteral Medicines, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0703-4768_8e059cef-4e91-4995-9485-2349cf8a29a1 0703-4768 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090916 ANDA ANDA075184 Teva Parenteral Medicines, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0703-4805_2e848533-f4e3-4e3d-a29f-b39f3b5831bf 0703-4805 HUMAN PRESCRIPTION DRUG Mesna Mesna INJECTION, SOLUTION INTRAVENOUS 20020501 ANDA ANDA075764 Teva Parenteral Medicines, Inc. MESNA 100 mg/mL Cytoprotective Agent [EPC] N 20181231 0703-5040_0f82f5ce-e1c2-4ae5-a1c3-e35d1a4b52cf 0703-5040 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride doxorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19960901 ANDA ANDA064140 Teva Parenteral Medicines, Inc. DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0703-5043_0f82f5ce-e1c2-4ae5-a1c3-e35d1a4b52cf 0703-5043 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride doxorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19950901 ANDA ANDA064140 Teva Parenteral Medicines, Inc. DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0703-5046_0f82f5ce-e1c2-4ae5-a1c3-e35d1a4b52cf 0703-5046 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride doxorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19950901 ANDA ANDA064140 Teva Parenteral Medicines, Inc. DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0703-5051_47e15d08-5324-4d03-8ba2-1edc0e5137e6 0703-5051 HUMAN PRESCRIPTION DRUG Desmopressin acetate Desmopressin acetate INJECTION INTRAVENOUS 19971101 ANDA ANDA074888 Teva Parenteral Medicines, Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 0703-5054_47e15d08-5324-4d03-8ba2-1edc0e5137e6 0703-5054 HUMAN PRESCRIPTION DRUG Desmopressin acetate Desmopressin acetate INJECTION INTRAVENOUS 19971101 ANDA ANDA074888 Teva Parenteral Medicines, Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 0703-5075_308fc8a0-221e-4c2f-8c88-b20ae3846f89 0703-5075 HUMAN PRESCRIPTION DRUG Dacarbazine Dacarbazine INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19980827 ANDA ANDA075259 Teva Parenteral Medicines, Inc. DACARBAZINE 200 mg/20mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0703-5140_f7ee4005-2916-4fb2-bbc2-fe6fe9953c75 0703-5140 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19940201 ANDA ANDA081277 Teva Parenteral Medicines, Inc. LEUCOVORIN CALCIUM 100 mg/10mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0703-5145_2b65fe3e-05e3-4063-8232-31e434f1ccc8 0703-5145 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130513 ANDA ANDA040174 Teva Parenteral Medicines, Inc. LEUCOVORIN CALCIUM 350 mg/17.5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0703-5145_f7ee4005-2916-4fb2-bbc2-fe6fe9953c75 0703-5145 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970612 ANDA ANDA040174 Teva Parenteral Medicines, Inc. LEUCOVORIN CALCIUM 350 mg/17.5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 0703-5233_7b50db67-621a-4022-a9d1-186683a1a52d 0703-5233 HUMAN PRESCRIPTION DRUG daunorubicin hydrochloride daunorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20040401 ANDA ANDA065035 Teva Parenteral Medicines, Inc. DAUNORUBICIN HYDROCHLORIDE 5 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0703-5233_b4f2e95a-37fb-41f9-b8be-c96c884a5498 0703-5233 HUMAN PRESCRIPTION DRUG daunorubicin hydrochloride daunorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20040401 ANDA ANDA065035 Teva Parenteral Medicines, Inc. DAUNORUBICIN HYDROCHLORIDE 5 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 0703-5653_7e4d6274-b5fc-4d26-8911-78214a237a04 0703-5653 HUMAN PRESCRIPTION DRUG Toposar Etoposide INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19960801 ANDA ANDA074529 Teva Parenteral Medicines, Inc. ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0703-5656_7e4d6274-b5fc-4d26-8911-78214a237a04 0703-5656 HUMAN PRESCRIPTION DRUG Toposar Etoposide INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19960801 ANDA ANDA074529 Teva Parenteral Medicines, Inc. ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0703-5657_7e4d6274-b5fc-4d26-8911-78214a237a04 0703-5657 HUMAN PRESCRIPTION DRUG Toposar Etoposide INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19970501 ANDA ANDA074529 Teva Parenteral Medicines, Inc. ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 0703-5720_041cf665-2c3c-4c18-b7c8-d774e00d5aea 0703-5720 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160211 ANDA ANDA203877 Teva Parenteral Medicines, Inc. DOCETAXEL ANHYDROUS 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0703-5730_041cf665-2c3c-4c18-b7c8-d774e00d5aea 0703-5730 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160211 ANDA ANDA203877 Teva Parenteral Medicines, Inc. DOCETAXEL ANHYDROUS 80 mg/4mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0703-5747_c4677a91-9ae8-437d-b812-b7d63093b94a 0703-5747 HUMAN PRESCRIPTION DRUG Cisplatin Cisplatin INJECTION, SOLUTION INTRAVENOUS 20000601 ANDA ANDA074656 Teva Parenteral Medicines, Inc. CISPLATIN 50 mg/50mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-5748_c4677a91-9ae8-437d-b812-b7d63093b94a 0703-5748 HUMAN PRESCRIPTION DRUG Cisplatin Cisplatin INJECTION, SOLUTION INTRAVENOUS 20000601 ANDA ANDA074656 Teva Parenteral Medicines, Inc. CISPLATIN 100 mg/100mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0703-5854_e138bb88-2459-440d-ac50-fbb561c4b4b3 0703-5854 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20030912 20181231 ANDA ANDA076349 Teva Parenteral Medicines, Inc. FLUDARABINE PHOSPHATE 50 mg/2mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0703-6801_bc46b725-27f7-4c7f-bd30-e40610bac905 0703-6801 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate INJECTION, SUSPENSION INTRAMUSCULAR 20040914 ANDA ANDA076553 Teva Parenteral Medicines, Inc. MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 0703-7011_875bb30b-6b36-4fe9-bd5d-5ee6296047c7 0703-7011 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 19990604 ANDA ANDA075393 Teva Parenteral Medicines, Inc. HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] N 20181231 0703-7013_875bb30b-6b36-4fe9-bd5d-5ee6296047c7 0703-7013 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 19990701 ANDA ANDA075393 Teva Parenteral Medicines, Inc. HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] N 20181231 0703-7021_875bb30b-6b36-4fe9-bd5d-5ee6296047c7 0703-7021 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 19990604 ANDA ANDA075393 Teva Parenteral Medicines, Inc. HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] N 20181231 0703-7023_875bb30b-6b36-4fe9-bd5d-5ee6296047c7 0703-7023 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 19990701 ANDA ANDA075393 Teva Parenteral Medicines, Inc. HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] N 20181231 0703-7221_5c91291c-3ea7-4207-92c0-162a896842d1 0703-7221 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061122 ANDA ANDA076759 Teva Parenteral Medicines, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0703-7226_d0e92775-d227-4e79-993d-c987654d74af 0703-7226 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061122 ANDA ANDA076876 Teva Parenteral Medicines, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0703-7351_81f4fdb8-f33a-42bb-a2bf-cd5a38c4c40f 0703-7351 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate INJECTION, SOLUTION SUBCUTANEOUS 20090206 ANDA ANDA077907 Teva Parenteral Medicines, Inc. SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0703-8401_d3b2d6be-40c0-4e47-a762-9289fee37617 0703-8401 HUMAN PRESCRIPTION DRUG Enalaprilat Enalaprilat INJECTION, SOLUTION INTRAVENOUS 20051006 ANDA ANDA075578 Teva Parenteral Medicines, Inc. ENALAPRILAT 1.25 mg/mL Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0703-8411_d3b2d6be-40c0-4e47-a762-9289fee37617 0703-8411 HUMAN PRESCRIPTION DRUG Enalaprilat Enalaprilat INJECTION, SOLUTION INTRAVENOUS 20051006 ANDA ANDA075578 Teva Parenteral Medicines, Inc. ENALAPRILAT 1.25 mg/mL Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0703-8510_be8aaa0a-dd91-4f55-a5d5-c0290230a228 0703-8510 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20150219 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0703-8530_be8aaa0a-dd91-4f55-a5d5-c0290230a228 0703-8530 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20141219 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0703-8540_be8aaa0a-dd91-4f55-a5d5-c0290230a228 0703-8540 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20141117 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0703-8560_be8aaa0a-dd91-4f55-a5d5-c0290230a228 0703-8560 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20141117 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0703-8580_be8aaa0a-dd91-4f55-a5d5-c0290230a228 0703-8580 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20150220 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0703-8610_be8aaa0a-dd91-4f55-a5d5-c0290230a228 0703-8610 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20141222 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0703-8680_be8aaa0a-dd91-4f55-a5d5-c0290230a228 0703-8680 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20141219 ANDA ANDA076726 Teva Parenteral Medicines, Inc. ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0703-8776_b691afe0-adcf-452f-a4c4-939c1c779c62 0703-8776 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20130923 ANDA ANDA077425 Teva Parenteral Medicines, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 0703-8777_b691afe0-adcf-452f-a4c4-939c1c779c62 0703-8777 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20130923 ANDA ANDA077425 Teva Parenteral Medicines, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 0703-9032_dd2f3ab2-99d0-44a2-b870-c858a49b4ba4 0703-9032 HUMAN PRESCRIPTION DRUG Amikacin Sulfate Amikacin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19931001 ANDA ANDA064045 Teva Parenteral Medicines, Inc. AMIKACIN SULFATE 500 mg/2mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 0703-9040_dd2f3ab2-99d0-44a2-b870-c858a49b4ba4 0703-9040 HUMAN PRESCRIPTION DRUG Amikacin Sulfate Amikacin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19931001 ANDA ANDA064045 Teva Parenteral Medicines, Inc. AMIKACIN SULFATE 1 g/4mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 0703-9060_98940317-0415-4bc1-92b6-2001838b5583 0703-9060 HUMAN PRESCRIPTION DRUG Linezolid Linezolid INJECTION, SOLUTION INTRAVENOUS 20150105 ANDA ANDA200222 Teva Parenteral Medicines, Inc. LINEZOLID 2 mg/mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0703-9258_45b8b475-ff2a-40c1-b330-0db3934d3e43 0703-9258 HUMAN PRESCRIPTION DRUG Sterile Diluent Sterile Diluent INJECTION INTRAVENOUS 20080423 ANDA ANDA078396 Teva Parenteral Medicines, Inc. WATER 1 mL/mL N 20181231 0703-9402_e4da8c2a-f317-4ba5-a63c-85d20fcef8be 0703-9402 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19920201 ANDA ANDA063100 Teva Parenteral Medicines, Inc. TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 0703-9416_e4da8c2a-f317-4ba5-a63c-85d20fcef8be 0703-9416 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19920201 ANDA ANDA063100 Teva Parenteral Medicines, Inc. TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 0703-9503_c2adb83b-6c7c-4afe-a41b-5f9a51bdbdb8 0703-9503 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19911101 ANDA ANDA073303 Teva Parenteral Medicines, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 80; 16 mg/mL; mg/mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0703-9514_c2adb83b-6c7c-4afe-a41b-5f9a51bdbdb8 0703-9514 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19911101 ANDA ANDA073303 Teva Parenteral Medicines, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 80; 16 mg/mL; mg/mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0703-9514_e6bc69ba-8e15-4c79-8740-69a26ee0cda5 0703-9514 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20151201 ANDA ANDA073303 Teva Parenteral Medicines, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 80; 16 mg/mL; mg/mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0703-9526_c2adb83b-6c7c-4afe-a41b-5f9a51bdbdb8 0703-9526 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19911101 ANDA ANDA073303 Teva Parenteral Medicines, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 80; 16 mg/mL; mg/mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 0713-0101_2d1c5464-7c85-4e78-42aa-f0d4a2b7fe93 0713-0101 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 19870608 OTC MONOGRAPH NOT FINAL part334 G&W Laboratories, Inc. GLYCERIN 2.1 g/1 N 20181231 0713-0102_e73c87dc-b94c-fe96-7d7d-e40b5b795546 0713-0102 HUMAN OTC DRUG Pediatric Glycerin Glycerin SUPPOSITORY RECTAL 19870608 OTC MONOGRAPH NOT FINAL part334 G&W Laboratories, Inc. GLYCERIN 1.2 g/1 N 20181231 0713-0109_84c0edcc-0771-f286-abc7-d6be0300629f 0713-0109 HUMAN OTC DRUG BISAC-EVAC Bisacodyl SUPPOSITORY RECTAL 19910522 OTC MONOGRAPH NOT FINAL part334 G&W Laboratories, Inc. BISACODYL 10 mg/1 N 20181231 0713-0118_04f1e98d-9a5c-2a09-bccf-aff5a842623d 0713-0118 HUMAN OTC DRUG ACEPHEN Acetaminophen SUPPOSITORY RECTAL 19820101 NDA NDA018060 G&W Laboratories, Inc. ACETAMINOPHEN 120 mg/1 N 20181231 0713-0132_1dd4b532-7463-f8db-f082-c1430016279d 0713-0132 HUMAN PRESCRIPTION DRUG PROMETHEGAN promethazine hydrochloride SUPPOSITORY RECTAL 19870831 ANDA ANDA087165 G&W Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0713-0135_9b40b2be-7999-65e4-7923-4fd9afe64284 0713-0135 HUMAN PRESCRIPTION DRUG Prochlorperazine Prochlorperazine SUPPOSITORY RECTAL 19931130 ANDA ANDA040058 G&W Laboratories, Inc. PROCHLORPERAZINE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0713-0164_40b9001f-28e5-4087-b83f-0c80c91fa938 0713-0164 HUMAN OTC DRUG ACEPHEN Acetaminophen SUPPOSITORY RECTAL 19920327 ANDA ANDA072344 G&W Laboratories, Inc. ACETAMINOPHEN 325 mg/1 N 20181231 0713-0165_c06a3b1d-c77a-0f88-0758-a87c4975d1ae 0713-0165 HUMAN OTC DRUG ACEPHEN Acetaminophen SUPPOSITORY RECTAL 19920327 ANDA ANDA072237 G&W Laboratories, Inc. ACETAMINOPHEN 650 mg/1 N 20181231 0713-0166_1ebbee1f-aae8-d341-f36b-c8b4609a5fc5 0713-0166 HUMAN PRESCRIPTION DRUG MIGERGOT Ergotamine Tartrate and Caffeine SUPPOSITORY RECTAL 19831030 ANDA ANDA086557 G&W Laboratories, Inc. ERGOTAMINE TARTRATE; CAFFEINE 2; 100 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0713-0176_0c313fa9-19f8-7f06-76a8-214170309857 0713-0176 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN SUPPOSITORY RECTAL 19920831 ANDA ANDA073314 G & W LABORATORIES, INC. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0713-0197_b7df48ff-f359-cea4-bef2-39f7974f034c 0713-0197 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate SUPPOSITORY VAGINAL 19970430 ANDA ANDA074414 G&W Laboratories, Inc. MICONAZOLE NITRATE 100 ug/1 N 20181231 0713-0222_f6d67cc2-8c66-44da-aa0c-058abda11169 0713-0222 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide CREAM TOPICAL 19880726 ANDA ANDA089525 G&W Laboratories, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0223_f6d67cc2-8c66-44da-aa0c-058abda11169 0713-0223 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide CREAM TOPICAL 19880726 ANDA ANDA089526 G&W Laboratories, Inc. FLUOCINOLONE ACETONIDE .1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0224_f6d67cc2-8c66-44da-aa0c-058abda11169 0713-0224 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OINTMENT TOPICAL 19880726 ANDA ANDA089524 G&W Laboratories, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0225_f4e86be7-5703-1805-ff09-4fa2acb433d8 0713-0225 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20150414 ANDA ANDA089798 G&W Laboratories, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0226_f4e86be7-5703-1805-ff09-4fa2acb433d8 0713-0226 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20150414 ANDA ANDA089797 G&W Laboratories, Inc. TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0228_15010f3d-f8aa-df30-e0d9-46df45d88325 0713-0228 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20150910 ANDA ANDA089796 G&W Laboratories, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0229_15010f3d-f8aa-df30-e0d9-46df45d88325 0713-0229 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20150910 ANDA ANDA089795 G&W Laboratories, Inc. TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0252_5c0d3219-91fe-6138-744d-822e707ac2e2 0713-0252 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM VAGINAL 19960222 ANDA ANDA074366 G&W Laboratories, Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 0713-0268_ee288720-fd49-aef3-fda4-761060ad08bb 0713-0268 HUMAN OTC DRUG Triple Antibiotic Ointment Polymyxin B Sulfate, Bacitracin Zinc, Neomycin Sulfate OINTMENT TOPICAL 19950111 OTC MONOGRAPH FINAL part333B G&W Laboratories, Inc. POLYMYXIN B SULFATE; NEOMYCIN; BACITRACIN ZINC 5000; 3.5; 400 [USP'U]/g; mg/g; [USP'U]/g N 20181231 0713-0280_e4a0e5d7-66d3-73fc-8a2a-c49b4b521989 0713-0280 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 19950110 OTC MONOGRAPH FINAL part333B G&W Laboratories, Inc. BACITRACIN 500 [USP'U]/g N 20181231 0713-0317_a1288bbb-ed71-0849-cb04-aa92afc0b49a 0713-0317 HUMAN PRESCRIPTION DRUG Ciclopirox CICLOPIROX SOLUTION TOPICAL 20070522 ANDA ANDA078233 G&W Laboratories, Inc. CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 0713-0318_59f3e723-78ce-e85b-222c-b8399c833056 0713-0318 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene SOLUTION TOPICAL 20110404 ANDA ANDA078468 G&W Laboratories, Inc. CALCIPOTRIENE .05 mg/mL Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 0713-0324_93c16f2e-294c-1605-b02d-2b385c17cea0 0713-0324 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide CREAM TOPICAL 20131220 ANDA ANDA089525 G&W Laboratories, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0325_63dd4e14-d729-f63b-aafa-3be2beca9781 0713-0325 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide SOLUTION TOPICAL 20160928 ANDA ANDA207441 G&W Laboratories, Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0326_74a4ab8a-50a1-4b55-8066-46045440df96 0713-0326 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate CREAM TOPICAL 20160331 NDA NDA018642 G&W Laboratories, Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0327_74a4ab8a-50a1-4b55-8066-46045440df96 0713-0327 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate OINTMENT TOPICAL 20151016 ANDA ANDA070069 G&W Laboratories, Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0427_bb45f3c4-8c7f-4319-9fd4-ed2ea64501df 0713-0427 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20160429 ANDA ANDA204446 G&W Laboratories, Inc. DOXYCYCLINE 50 mg/1 N 20181231 0713-0428_bb45f3c4-8c7f-4319-9fd4-ed2ea64501df 0713-0428 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20160429 ANDA ANDA204446 G&W Laboratories, Inc. DOXYCYCLINE 75 mg/1 N 20181231 0713-0429_bb45f3c4-8c7f-4319-9fd4-ed2ea64501df 0713-0429 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20160429 ANDA ANDA204446 G&W Laboratories, Inc. DOXYCYCLINE 100 mg/1 N 20181231 0713-0503_f8125ab3-1dc4-ba10-718c-8263821efe67 0713-0503 HUMAN PRESCRIPTION DRUG ANUCORT-HC Hydrocortisone Acetate SUPPOSITORY RECTAL 19900115 UNAPPROVED DRUG OTHER G&W Laboratories, Inc. HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0526_571ff6f4-47e4-5491-b6da-13a653960a6d 0713-0526 HUMAN PRESCRIPTION DRUG PROMETHEGAN Promethazine Hydrochloride SUPPOSITORY RECTAL 20020228 ANDA ANDA040428 G&W Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0713-0535_17cecb0a-0c16-cdda-744e-a3dea9333e1e 0713-0535 HUMAN OTC DRUG Formulation R Phenylephrine Hydrochloride, Hydrogenate Palm Kernel Oil SUPPOSITORY RECTAL 20020624 OTC MONOGRAPH FINAL part346 G&W Laboratories, Inc. PHENYLEPHRINE HYDROCHLORIDE; HYDROGENATED PALM KERNEL OIL 2.5; 855 mg/1; mg/1 N 20181231 0713-0536_571ff6f4-47e4-5491-b6da-13a653960a6d 0713-0536 HUMAN PRESCRIPTION DRUG PROMETHEGAN promethazine hydrochloride SUPPOSITORY RECTAL 20040228 ANDA ANDA040428 G&W Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0713-0552_c256e979-3d0c-4368-a22f-6a86f866ec25 0713-0552 HUMAN PRESCRIPTION DRUG Terconazole Terconazole SUPPOSITORY VAGINAL 20150925 ANDA ANDA077553 G & W Laboratories, Inc. TERCONAZOLE 80 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 0713-0622_cc87a9af-8a9f-5a57-b08c-f97b773ab743 0713-0622 HUMAN OTC DRUG Triple Antibiotic Plus Polymyxin B Sulfate, Bacitracin Zinc, Neomycin Sulfate, Pramoxine HCl OINTMENT TOPICAL 19980228 OTC MONOGRAPH FINAL part333B G&W Laboratories, Inc. POLYMYXIN B SULFATE; BACITRACIN ZINC; NEOMYCIN; PRAMOXINE HYDROCHLORIDE 10000; 500; 3.5; 10 [USP'U]/g; [USP'U]/g; mg/g; mg/g N 20181231 0713-0623_7e5dc3de-e933-327d-a055-625b921c46a1 0713-0623 HUMAN OTC DRUG Carlesta Dimethicone, Zinc Oxide OINTMENT TOPICAL 19990908 OTC MONOGRAPH FINAL part347 G&W Laboratories, Inc. DIMETHICONE; ZINC OXIDE 20; 260 mg/g; mg/g N 20181231 0713-0630_8df4fee3-8582-431c-b91e-c03786a5cb7c 0713-0630 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir OINTMENT TOPICAL 20171113 ANDA ANDA205591 G&W Laboratories, Inc. ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0713-0631_6135426e-2ac6-cfb2-3d47-d97cb3383408 0713-0631 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate CREAM TOPICAL 20060630 ANDA ANDA077055 G&W Laboratories, Inc. FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0632_81471be5-5571-41fa-a984-7fe51501f2e4 0713-0632 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate OINTMENT TOPICAL 20060531 ANDA ANDA077168 G&W Laboratories, Inc. FLUTICASONE PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0633_20b3f84b-df00-d5c0-6dd1-fa2b58a2bf7e 0713-0633 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole CREAM TOPICAL 20080313 ANDA ANDA077549 G&W Laboratories, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0713-0634_2ea8dd4d-b886-b60e-c959-0b5ebe75f12f 0713-0634 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20060823 ANDA ANDA077447 G&W Laboratories, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0635_08d630fc-ab92-0bac-b696-3ec08d1cecf1 0713-0635 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20140304 ANDA ANDA077401 G&W Laboratories, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0637_6a5e6116-c487-a25d-69bb-1da0de3bc5d0 0713-0637 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20110401 ANDA ANDA078178 G&W Laboratories, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0713-0638_016fc036-89b0-4c3b-865a-ac5d4656fc6d 0713-0638 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine Ciclopirox Olamine CREAM TOPICAL 20070522 ANDA ANDA078463 G&W Laboratories, Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 0713-0639_e4c88e9b-efa7-13a5-f1c3-675bec987e1d 0713-0639 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate OINTMENT TOPICAL 20160921 ANDA ANDA077721 G&W Laboratories, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0640_a96f24b2-9109-fbb2-5940-0ff02dfc6509 0713-0640 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate CREAM TOPICAL 20070716 ANDA ANDA078162 G&W Laboratories, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0655_e5ec00b4-b082-47e3-8009-a4a9106bc81a 0713-0655 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE DENTAL 20170113 ANDA ANDA205592 G&W Laboratories, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0656_5492f828-1879-53d1-b598-d18ee31f749b 0713-0656 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate Ointment OINTMENT TOPICAL 20160104 ANDA ANDA074089 G&W Laboratories, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0657_6f07d477-865d-1cd1-a65d-1e2614c1c6a5 0713-0657 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20160901 ANDA ANDA206740 G&W Laboratories, Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0661_90a1c83b-0258-2f4b-e740-8c81cc2916c7 0713-0661 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 20160819 ANDA ANDA074027 G&W Laboratories, Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0668_5f36b217-e55c-4f33-811e-534eb67eb00d 0713-0668 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate CREAM TOPICAL 19980825 ANDA ANDA075042 G&W Laboratories, Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0669_fda91acf-8a29-4094-9f52-2c1d61ee1420 0713-0669 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate HYDROCORTISONE VALERATE OINTMENT TOPICAL 19980825 ANDA ANDA075043 G&W Laboratories, Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0670_61f9d2b4-6687-1ad1-e053-2991aa0a88a1 0713-0670 HUMAN PRESCRIPTION DRUG Tazarotene Tazarotene CREAM TOPICAL 20171222 ANDA ANDA208662 G&W Laboratories, Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 0713-0671_6f17892d-bcf0-4173-9090-67c5a9bedcfe 0713-0671 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20150615 ANDA ANDA075581 G&W Laboratories, Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0713-0676_82c1efdd-243b-eba5-a456-81694185dd74 0713-0676 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide LOTION TOPICAL 20160913 ANDA ANDA089129 G&W Laboratories, Inc. TRIAMCINOLONE ACETONIDE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0678_5337115c-1f84-e2ea-863e-31458b8b53f9 0713-0678 HUMAN PRESCRIPTION DRUG Nystatin Nystatin Cream CREAM TOPICAL 20150401 ANDA ANDA061966 G&W Laboratories, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0713-0679_83e78ba3-7c48-4081-a1e6-6f9c5aea677d 0713-0679 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20171031 ANDA ANDA208925 G&W Laboratories, Inc. TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0683_d1b960f3-18bf-9574-0569-1affdb4e5279 0713-0683 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate CREAM TOPICAL 20161111 ANDA ANDA064056 G&W Laboratories, Inc. GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0713-0686_13ac403a-0f59-4049-b784-6127d1e05320 0713-0686 HUMAN PRESCRIPTION DRUG Nystatin Nystatin Ointment OINTMENT TOPICAL 20171006 ANDA ANDA209114 G&W Laboratories, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0713-0701_7bd77dac-ec3b-5ba3-5814-9521bcc6ee83 0713-0701 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate SOLUTION TOPICAL 20140304 ANDA ANDA077678 G&W Laboratories, Inc. MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0703_3bb57616-ce87-5a68-17d7-8dc7f2963a1f 0713-0703 HUMAN PRESCRIPTION DRUG Hycet Hydrocodone bitartrate and acetaminophen SOLUTION ORAL 20110201 ANDA ANDA040482 G&W Laboratories, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0713-0704_7068bb40-bcc8-1d45-09e7-5dac7f01fe4a 0713-0704 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone bitartrate and acetaminophen SOLUTION ORAL 20110201 ANDA ANDA040482 G&W Laboratories, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 0713-0803_1c6c6b8d-0e0e-4360-81e7-ae58693e81e2 0713-0803 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide GEL TOPICAL 20151218 ANDA ANDA072537 G&W Laboratories, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-0807_fdbc9c21-fd48-3ed6-3758-f52a62ccf34c 0713-0807 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate LOTION TOPICAL 20160905 ANDA ANDA071467 G&W Laboratories, Inc. BETAMETHASONE DIPROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0713-1044_fdf382f6-83a4-435c-aec9-a6a26dee23a6 0713-1044 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20160331 ANDA ANDA075727 G&W Laboratories, Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0713-1052_fdf382f6-83a4-435c-aec9-a6a26dee23a6 0713-1052 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20160331 ANDA ANDA075727 G&W Laboratories, Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0713-3171_7279d2ac-27ee-48bc-8081-5862e1a74f11 0713-3171 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20160314 ANDA ANDA063029 G&W Laboratories, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0713-4740_71ef9642-ff70-453e-a7ae-27bf5c281f83 0713-4740 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Tablets TABLET ORAL 20151202 ANDA ANDA077048 G&W Laboratories, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0713-4741_71ef9642-ff70-453e-a7ae-27bf5c281f83 0713-4741 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Tablet TABLET ORAL 20151202 ANDA ANDA077048 G&W Laboratories, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0713-4742_71ef9642-ff70-453e-a7ae-27bf5c281f83 0713-4742 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Tablet TABLET ORAL 20151202 ANDA ANDA077048 G&W Laboratories, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0713-5256_7279d2ac-27ee-48bc-8081-5862e1a74f11 0713-5256 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20160314 ANDA ANDA063029 G&W Laboratories, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0722-6094_1b17ad8e-0cfb-458a-bb16-bc397376bcf9 0722-6094 HUMAN PRESCRIPTION DRUG Ascomp with Codeine Butalbital, Aspirin, Cafeine, and Codeine Phosphate CAPSULE ORAL 20011130 ANDA ANDA075231 Nexgen Pharma, Inc. BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0722-6670_1f2035cb-8e9c-4be7-a565-44cd7a1b3d05 0722-6670 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20040610 ANDA ANDA076560 Nexgen Pharma, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0722-6920_71508b14-3d59-408c-b43c-aff2f47b8b3d 0722-6920 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20060927 ANDA ANDA077706 Nexgen Pharma, Inc. POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 0722-6921_d0d2f068-4453-4ea2-8282-339b6e497a9a 0722-6921 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20060927 ANDA ANDA077706 Nexgen Pharma, Inc. POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 0722-7028_acba0f97-402d-41d4-82d3-37f3f7da8ac0 0722-7028 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20120720 ANDA ANDA076560 Nexgen Pharma, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE 50; 300; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 0722-7029_3d819ef5-f676-4d0d-b2d4-256136842750 0722-7029 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine Capsules CAPSULE ORAL 20091116 ANDA ANDA040885 Nexgen Pharma, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 300; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 0722-7075_0feca9fa-fde3-4d5d-bb6a-2886572933a0 0722-7075 HUMAN PRESCRIPTION DRUG Butalbital and Acetaminophen Butalbital and Acetaminophen TABLET ORAL 20110401 ANDA ANDA090956 Nexgen Pharma, Inc. BUTALBITAL; ACETAMINOPHEN 50; 300 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] CIII E 20171231 0722-7097_06bb6f89-4694-4aaa-8bff-f7f3c81d3add 0722-7097 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20120312 ANDA ANDA091522 Nexgen Pharma, Inc. GLYCOPYRROLATE 1.5 mg/1 N 20181231 0722-7116_d6218f65-1b41-417e-b928-56ac6db411af 0722-7116 HUMAN OTC DRUG Polyethylene Glycol 3350, NF Powder for Solution, Laxative Polyethylene Glycol 3350, NF Powder for Solution, Laxative POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090812 Nexgen Pharma, Inc. POLYETHYLENE GLYCOL 3350 17 g/d E 20171231 0722-7121_8ba63d22-cb7b-4185-b212-fa1d6b295c8a 0722-7121 HUMAN PRESCRIPTION DRUG Chenodiol Chenodiol TABLET, FILM COATED ORAL 20091001 ANDA ANDA091019 Nexgen Pharma, Inc. CHENODIOL 250 mg/1 E 20171231 0722-7183_b87994ee-26a5-4d00-99e7-796bc17961f1 0722-7183 HUMAN PRESCRIPTION DRUG Mecamylamine Hydrochloride Mecamylamine Hydrochloride TABLET ORAL 20130319 ANDA ANDA204054 Nexgen Pharma, Inc. MECAMYLAMINE HYDROCHLORIDE 2.5 mg/1 Autonomic Ganglionic Blocker [EPC],Decreased Autonomic Ganglionic Activity [PE] N 20181231 0722-7184_6feb059d-5153-42a5-9306-6b05429ca86d 0722-7184 HUMAN PRESCRIPTION DRUG CODEINE AND CHLORPHENIRAMINE MALEATE ER CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE ORAL 20150901 NDA NDA206323 Nexgen Pharma, Inc. CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE 54.3; 8 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII N 20181231 0761-0414_5d571284-2251-6466-e053-2a91aa0aa9ef 0761-0414 HUMAN OTC DRUG Laxa-basic 100 Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20120101 OTC MONOGRAPH NOT FINAL part334 Basic Drugs, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 0777-3104_69810581-decb-4cd6-8a1b-d6d83e75d17f 0777-3104 HUMAN PRESCRIPTION DRUG Prozac Fluoxetine hydrochloride CAPSULE ORAL 19930113 NDA NDA018936 Dista Products Company FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0777-3105_69810581-decb-4cd6-8a1b-d6d83e75d17f 0777-3105 HUMAN PRESCRIPTION DRUG Prozac Fluoxetine hydrochloride CAPSULE ORAL 19880201 NDA NDA018936 Dista Products Company FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0777-3107_69810581-decb-4cd6-8a1b-d6d83e75d17f 0777-3107 HUMAN PRESCRIPTION DRUG Prozac Fluoxetine hydrochloride CAPSULE ORAL 19990615 NDA NDA018936 Dista Products Company FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0781-1008_2817a13e-1e33-4429-8eca-78dc1191aa3d 0781-1008 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19880617 ANDA ANDA072011 Sandoz Inc TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-1030_abc79c69-2f26-47df-8ead-b5ffadb62b7c 0781-1030 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET, FILM COATED ORAL 19811120 ANDA ANDA085785 Sandoz Inc TRIFLUOPERAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1032_abc79c69-2f26-47df-8ead-b5ffadb62b7c 0781-1032 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET, FILM COATED ORAL 19811120 ANDA ANDA085786 Sandoz Inc TRIFLUOPERAZINE HYDROCHLORIDE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1034_abc79c69-2f26-47df-8ead-b5ffadb62b7c 0781-1034 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET, FILM COATED ORAL 19811120 ANDA ANDA085789 Sandoz Inc TRIFLUOPERAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1036_abc79c69-2f26-47df-8ead-b5ffadb62b7c 0781-1036 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET, FILM COATED ORAL 19811120 ANDA ANDA085788 Sandoz Inc TRIFLUOPERAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1046_5cb4ac95-dceb-4e57-9634-56203af3c534 0781-1046 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089683 Sandoz Inc PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1047_5cb4ac95-dceb-4e57-9634-56203af3c534 0781-1047 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089684 Sandoz Inc PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1048_5cb4ac95-dceb-4e57-9634-56203af3c534 0781-1048 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089685 Sandoz Inc PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1049_5cb4ac95-dceb-4e57-9634-56203af3c534 0781-1049 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089686 Sandoz Inc PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1053_b411f4b8-890b-4e62-932e-52aea9ef6c76 0781-1053 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Sandoz Inc BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0781-1061_b1a5ac7c-71d0-4e53-bc06-9597f08d1dad 0781-1061 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Sandoz Inc ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-1064_b411f4b8-890b-4e62-932e-52aea9ef6c76 0781-1064 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Sandoz Inc BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0781-1071_4474945b-2d10-494c-92e3-d783943d2080 0781-1071 HUMAN PRESCRIPTION DRUG Methazolamide Methazolamide TABLET ORAL 19930630 ANDA ANDA040036 Sandoz Inc METHAZOLAMIDE 50 mg/1 N 20181231 0781-1072_4474945b-2d10-494c-92e3-d783943d2080 0781-1072 HUMAN PRESCRIPTION DRUG Methazolamide Methazolamide TABLET ORAL 19930630 ANDA ANDA040036 Sandoz Inc METHAZOLAMIDE 25 mg/1 N 20181231 0781-1077_b1a5ac7c-71d0-4e53-bc06-9597f08d1dad 0781-1077 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Sandoz Inc ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-1078_0711521b-a3f3-4f99-ac53-9238774b2db7 0781-1078 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 Sandoz Inc ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0781-1079_b1a5ac7c-71d0-4e53-bc06-9597f08d1dad 0781-1079 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Sandoz Inc ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-1089_b1a5ac7c-71d0-4e53-bc06-9597f08d1dad 0781-1089 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19980325 ANDA ANDA074909 Sandoz Inc ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-1123_2817a13e-1e33-4429-8eca-78dc1191aa3d 0781-1123 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19920430 ANDA ANDA073281 Sandoz Inc TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-1181_ed2ee5af-c827-4a41-a12e-f9ec3e6a9005 0781-1181 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Sandoz Inc NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0781-1182_ed2ee5af-c827-4a41-a12e-f9ec3e6a9005 0781-1182 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Sandoz Inc NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0781-1183_ed2ee5af-c827-4a41-a12e-f9ec3e6a9005 0781-1183 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Sandoz Inc NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0781-1205_b9e9003b-80ec-4cba-9344-6b53bc7a5684 0781-1205 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 19951130 ANDA ANDA064071 Sandoz Inc PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-1223_bc5385c0-9f93-4415-8f56-b0d2c63ad3e5 0781-1223 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19940325 ANDA ANDA073288 Sandoz Inc METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 0781-1228_bc5385c0-9f93-4415-8f56-b0d2c63ad3e5 0781-1228 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19940325 ANDA ANDA073289 Sandoz Inc METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 0781-1345_9250c587-1a02-418b-9f3f-31e9fe00fc5f 0781-1345 HUMAN OTC DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 19890522 OTC MONOGRAPH FINAL part336 Sandoz Inc MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 0781-1375_9250c587-1a02-418b-9f3f-31e9fe00fc5f 0781-1375 HUMAN OTC DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 19890522 OTC MONOGRAPH FINAL part336 Sandoz Inc MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 0781-1381_aa6f4f2a-5e51-46b2-8e6d-7846bb84611f 0781-1381 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960308 NDA AUTHORIZED GENERIC NDA020254 Sandoz Inc DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0781-1391_3f068b6c-a8b3-4214-9bd8-0e7d8e3f2a27 0781-1391 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071206 Sandoz Inc HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] N 20181231 0781-1392_3f068b6c-a8b3-4214-9bd8-0e7d8e3f2a27 0781-1392 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071207 Sandoz Inc HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] N 20181231 0781-1393_3f068b6c-a8b3-4214-9bd8-0e7d8e3f2a27 0781-1393 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071208 Sandoz Inc HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] N 20181231 0781-1396_3f068b6c-a8b3-4214-9bd8-0e7d8e3f2a27 0781-1396 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071209 Sandoz Inc HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 0781-1397_3f068b6c-a8b3-4214-9bd8-0e7d8e3f2a27 0781-1397 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19880311 ANDA ANDA071210 Sandoz Inc HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] N 20181231 0781-1398_3f068b6c-a8b3-4214-9bd8-0e7d8e3f2a27 0781-1398 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19880311 ANDA ANDA071211 Sandoz Inc HALOPERIDOL 20 mg/1 Typical Antipsychotic [EPC] N 20181231 0781-1407_9f44bec8-a0de-42a5-b207-355f274afd08 0781-1407 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 19951130 ANDA ANDA040104 Sandoz Inc HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 0781-1407_e12a3f5a-6819-4b7d-852e-9283155f6d56 0781-1407 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 19951130 ANDA ANDA040104 Sandoz Inc HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 0781-1436_3b0ecdab-005c-4df2-949a-a4f78dedebb1 0781-1436 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 Sandoz Inc FLUPHENAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1437_3b0ecdab-005c-4df2-949a-a4f78dedebb1 0781-1437 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 Sandoz Inc FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1438_3b0ecdab-005c-4df2-949a-a4f78dedebb1 0781-1438 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 Sandoz Inc FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1439_3b0ecdab-005c-4df2-949a-a4f78dedebb1 0781-1439 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 Sandoz Inc FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1446_41a5ae29-e9a4-4890-83de-61b9dda9188e 0781-1446 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 Sandoz Inc FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0781-1452_9418c9fb-e591-4338-a5ee-1efbe2bca21c 0781-1452 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Sandoz Inc GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0781-1453_9418c9fb-e591-4338-a5ee-1efbe2bca21c 0781-1453 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Sandoz Inc GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0781-1486_3c0c501c-99f7-4597-93c1-9f688e762eaa 0781-1486 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 Sandoz Inc AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1487_3c0c501c-99f7-4597-93c1-9f688e762eaa 0781-1487 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 Sandoz Inc AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1488_3c0c501c-99f7-4597-93c1-9f688e762eaa 0781-1488 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 Sandoz Inc AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1489_3c0c501c-99f7-4597-93c1-9f688e762eaa 0781-1489 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085971 Sandoz Inc AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1490_3c0c501c-99f7-4597-93c1-9f688e762eaa 0781-1490 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085967 Sandoz Inc AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1491_3c0c501c-99f7-4597-93c1-9f688e762eaa 0781-1491 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085970 Sandoz Inc AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1496_9d2b4fce-fdd4-4a16-b0e5-d97626beb546 0781-1496 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Sandoz Inc AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0781-1497_7b73fb88-a008-4961-b1c1-776487487ea0 0781-1497 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065209 Sandoz Inc AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0781-1506_0711521b-a3f3-4f99-ac53-9238774b2db7 0781-1506 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073025 Sandoz Inc ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0781-1507_0711521b-a3f3-4f99-ac53-9238774b2db7 0781-1507 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073026 Sandoz Inc ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0781-1516_46ed530a-fefa-4fb3-b6de-fa081b668712 0781-1516 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Sandoz Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0781-1526_46ed530a-fefa-4fb3-b6de-fa081b668712 0781-1526 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Sandoz Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0781-1556_8a48e28c-5a72-4744-9a58-2586a3d52135 0781-1556 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880107 ANDA ANDA086223 Sandoz Inc ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0781-1599_aa7e15c6-aa9b-43d3-9dbe-a17310edb5df 0781-1599 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 19820101 ANDA ANDA086809 Sandoz Inc SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0781-1619_2b1119d6-06a8-4e5f-a577-a0a3cf2b5f88 0781-1619 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20020418 ANDA ANDA065065 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-1635_8a48e28c-5a72-4744-9a58-2586a3d52135 0781-1635 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880107 ANDA ANDA086221 Sandoz Inc ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0781-1643_2b1119d6-06a8-4e5f-a577-a0a3cf2b5f88 0781-1643 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20020418 ANDA ANDA065065 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-1655_b9e9003b-80ec-4cba-9344-6b53bc7a5684 0781-1655 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 19951130 ANDA ANDA064071 Sandoz Inc PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-1679_55ea3833-08d6-4672-b0c6-2dd8f88f288f 0781-1679 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077517 Sandoz Inc ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0781-1681_55ea3833-08d6-4672-b0c6-2dd8f88f288f 0781-1681 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077517 Sandoz Inc ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0781-1683_abb8f747-037b-410c-8bdf-7115cfa741e9 0781-1683 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077946 Sandoz Inc CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 0781-1684_9b27ceca-79b8-4bab-be48-e0e4197d9a1e 0781-1684 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077946 Sandoz Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0781-1695_8a48e28c-5a72-4744-9a58-2586a3d52135 0781-1695 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880407 ANDA ANDA089367 Sandoz Inc ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0781-1762_86146bcb-0692-4179-9a5c-e730be23841f 0781-1762 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19760420 ANDA ANDA084936 Sandoz Inc IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1764_86146bcb-0692-4179-9a5c-e730be23841f 0781-1764 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19760420 ANDA ANDA083745 Sandoz Inc IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1766_86146bcb-0692-4179-9a5c-e730be23841f 0781-1766 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19760420 ANDA ANDA084937 Sandoz Inc IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1785_3977fc76-2962-42c8-95be-c5c002c516e1 0781-1785 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19950928 ANDA ANDA074376 Sandoz Inc DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0781-1787_3977fc76-2962-42c8-95be-c5c002c516e1 0781-1787 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19950928 ANDA ANDA074376 Sandoz Inc DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0781-1789_3977fc76-2962-42c8-95be-c5c002c516e1 0781-1789 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19951130 ANDA ANDA074394 Sandoz Inc DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0781-1818_41a5ae29-e9a4-4890-83de-61b9dda9188e 0781-1818 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 Sandoz Inc FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0781-1830_307623c2-cfde-453e-9e76-59349d909a26 0781-1830 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19751219 ANDA ANDA084176 Sandoz Inc PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1831_2b1119d6-06a8-4e5f-a577-a0a3cf2b5f88 0781-1831 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20020315 ANDA ANDA065064 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-1832_307623c2-cfde-453e-9e76-59349d909a26 0781-1832 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19750218 ANDA ANDA084176 Sandoz Inc PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-1852_2b1119d6-06a8-4e5f-a577-a0a3cf2b5f88 0781-1852 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20020314 ANDA ANDA065063 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-1874_2b1119d6-06a8-4e5f-a577-a0a3cf2b5f88 0781-1874 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20050823 ANDA ANDA065189 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-1883_97c5cff1-e9a3-420d-a34c-118758ef2a14 0781-1883 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA074467 Sandoz Inc RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0781-1884_97c5cff1-e9a3-420d-a34c-118758ef2a14 0781-1884 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 19970829 ANDA ANDA074467 Sandoz Inc RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0781-1941_9d2b4fce-fdd4-4a16-b0e5-d97626beb546 0781-1941 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065212 Sandoz Inc AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0781-1943_a12dd927-8482-4874-b8d2-a1ecc3c4aa1b 0781-1943 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, MULTILAYER, EXTENDED RELEASE ORAL 20100421 ANDA ANDA090227 Sandoz Inc AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM 562.5; 437.5; 62.5 mg/1; mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-1961_fda7939e-6a15-493c-96f1-b13db5152294 0781-1961 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20051018 ANDA ANDA065144 Sandoz Inc CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0781-1962_fda7939e-6a15-493c-96f1-b13db5152294 0781-1962 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20050825 ANDA ANDA065136 Sandoz Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0781-1966_41a5ae29-e9a4-4890-83de-61b9dda9188e 0781-1966 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 Sandoz Inc FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0781-1972_b29100b1-2813-4e85-ba28-d99df85aa522 0781-1972 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880524 ANDA ANDA072100 Sandoz Inc DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1973_b29100b1-2813-4e85-ba28-d99df85aa522 0781-1973 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880524 ANDA ANDA072101 Sandoz Inc DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1974_b29100b1-2813-4e85-ba28-d99df85aa522 0781-1974 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880620 ANDA ANDA072102 Sandoz Inc DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1975_b29100b1-2813-4e85-ba28-d99df85aa522 0781-1975 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880620 ANDA ANDA072103 Sandoz Inc DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-1976_b29100b1-2813-4e85-ba28-d99df85aa522 0781-1976 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880620 ANDA ANDA072104 Sandoz Inc DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-2020_d1babc2f-36e2-4270-8904-e5a0817d94c7 0781-2020 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Sandoz Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-2027_ca1865db-d006-4946-af3f-7ffbd9f840a8 0781-2027 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19960329 ANDA ANDA074364 Sandoz Inc CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-2037_ca1865db-d006-4946-af3f-7ffbd9f840a8 0781-2037 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19960329 ANDA ANDA074364 Sandoz Inc CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-2043_52ecf3bd-6c80-4361-804c-dac97bd735cb 0781-2043 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20040406 ANDA ANDA076192 Sandoz Inc RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 0781-2047_ca1865db-d006-4946-af3f-7ffbd9f840a8 0781-2047 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19960329 ANDA ANDA074364 Sandoz Inc CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-2048_f5c8b746-f578-4890-8c5d-775dd2a7f42f 0781-2048 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 Sandoz Inc AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 0781-2051_b8cbeb41-7cc5-4a47-b905-bc0a973d9478 0781-2051 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 19980330 ANDA ANDA074823 Sandoz Inc TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0781-2052_b8cbeb41-7cc5-4a47-b905-bc0a973d9478 0781-2052 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 19980330 ANDA ANDA074823 Sandoz Inc TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0781-2053_b8cbeb41-7cc5-4a47-b905-bc0a973d9478 0781-2053 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 19980330 ANDA ANDA074823 Sandoz Inc TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0781-2054_b8cbeb41-7cc5-4a47-b905-bc0a973d9478 0781-2054 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 19980330 ANDA ANDA074823 Sandoz Inc TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0781-2067_089ce0d0-3ead-489e-9911-6ce543f56c3c 0781-2067 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20081015 ANDA ANDA065379 Sandoz Inc MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 0781-2074_a8c9ccef-b3b6-4ba1-9dab-d889ec7a1f16 0781-2074 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19970605 ANDA ANDA074821 Sandoz Inc TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-2076_b0673b4e-ba08-4fa5-9052-ebe3b5449cc9 0781-2076 HUMAN PRESCRIPTION DRUG tamsulosin hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078015 Sandoz Inc TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0781-2081_5f87abb7-0e6d-6369-e053-2a91aa0a2411 0781-2081 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20120314 NDA AUTHORIZED GENERIC NDA021160 Sandoz Inc CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0781-2102_cd87c0ca-41e9-42ce-94fb-fec2563a8a9b 0781-2102 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20090810 ANDA ANDA065461 Sandoz Inc TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0781-2103_cd87c0ca-41e9-42ce-94fb-fec2563a8a9b 0781-2103 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20090810 ANDA ANDA065461 Sandoz Inc TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0781-2104_cd87c0ca-41e9-42ce-94fb-fec2563a8a9b 0781-2104 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20090810 ANDA ANDA065461 Sandoz Inc TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0781-2144_b8ee4974-d097-4537-875c-b164227dce5c 0781-2144 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19950829 ANDA ANDA064082 Sandoz Inc AMPICILLIN TRIHYDRATE 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-2145_b8ee4974-d097-4537-875c-b164227dce5c 0781-2145 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19950829 ANDA ANDA064082 Sandoz Inc AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-2147_586127c6-b9be-41ca-bd18-f7f513becd28 0781-2147 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20100423 ANDA ANDA090331 Sandoz Inc LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 0781-2148_586127c6-b9be-41ca-bd18-f7f513becd28 0781-2148 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20100423 ANDA ANDA090331 Sandoz Inc LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 0781-2164_3229e39f-4271-4075-981b-c68a56940e3a 0781-2164 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 Sandoz Inc ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-2166_3229e39f-4271-4075-981b-c68a56940e3a 0781-2166 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 Sandoz Inc ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-2167_3229e39f-4271-4075-981b-c68a56940e3a 0781-2167 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 Sandoz Inc ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-2168_3229e39f-4271-4075-981b-c68a56940e3a 0781-2168 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 Sandoz Inc ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-2176_2c919086-5a7b-4985-b2bd-14aeb60fce30 0781-2176 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070406 ANDA ANDA065330 Sandoz Inc CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-2191_a6017870-fd17-4b1f-91e6-9418d11b6d8b 0781-2191 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20121130 ANDA ANDA078901 Sandoz Inc OLANZAPINE; FLUOXETINE HYDROCHLORIDE 6; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0781-2192_a6017870-fd17-4b1f-91e6-9418d11b6d8b 0781-2192 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20121130 ANDA ANDA078901 Sandoz Inc OLANZAPINE; FLUOXETINE HYDROCHLORIDE 12; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0781-2193_a6017870-fd17-4b1f-91e6-9418d11b6d8b 0781-2193 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20121130 ANDA ANDA078901 Sandoz Inc OLANZAPINE; FLUOXETINE HYDROCHLORIDE 6; 50 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0781-2194_a6017870-fd17-4b1f-91e6-9418d11b6d8b 0781-2194 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20121130 ANDA ANDA078901 Sandoz Inc OLANZAPINE; FLUOXETINE HYDROCHLORIDE 12; 50 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0781-2195_a6017870-fd17-4b1f-91e6-9418d11b6d8b 0781-2195 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20121130 ANDA ANDA078901 Sandoz Inc OLANZAPINE; FLUOXETINE HYDROCHLORIDE 3; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0781-2201_bc88e0a5-2953-4860-aa15-ff13b7d25c03 0781-2201 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071427 Sandoz Inc TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-2202_bc88e0a5-2953-4860-aa15-ff13b7d25c03 0781-2202 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071428 Sandoz Inc TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-2226_b8c56a07-4ca0-48d2-9834-784c85b60fc2 0781-2226 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 19870624 ANDA ANDA071610 Sandoz Inc THIOTHIXENE 1 mg/1 Typical Antipsychotic [EPC] N 20181231 0781-2227_b8c56a07-4ca0-48d2-9834-784c85b60fc2 0781-2227 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 19870624 ANDA ANDA071570 Sandoz Inc THIOTHIXENE 2 mg/1 Typical Antipsychotic [EPC] N 20181231 0781-2228_b8c56a07-4ca0-48d2-9834-784c85b60fc2 0781-2228 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 19870624 ANDA ANDA071529 Sandoz Inc THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] N 20181231 0781-2229_b8c56a07-4ca0-48d2-9834-784c85b60fc2 0781-2229 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 19870624 ANDA ANDA071530 Sandoz Inc THIOTHIXENE 10 mg/1 Typical Antipsychotic [EPC] N 20181231 0781-2234_3d2e143b-4e17-4ca3-9c77-464fdbd0e58a 0781-2234 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA076515 Sandoz Inc OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0781-2243_b3e471f7-a645-7bfd-b05b-4f9e9107d33f 0781-2243 HUMAN PRESCRIPTION DRUG Divalproex Sodium Delayed Release (Sprinkle) Divalproex Sodium CAPSULE ORAL 20150831 NDA AUTHORIZED GENERIC NDA019680 Sandoz Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0781-2248_ed4f5e8c-609e-4689-813a-d6bb560e34b3 0781-2248 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19710401 ANDA ANDA061454 Sandoz Inc DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-2258_ed4f5e8c-609e-4689-813a-d6bb560e34b3 0781-2258 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19710401 ANDA ANDA061454 Sandoz Inc DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-2260_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2260 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0781-2261_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2261 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0781-2262_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2262 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0781-2263_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2263 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0781-2264_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2264 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0781-2265_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2265 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0781-2266_6b194d5b-7326-4baf-9e5a-d9ada2f369ca 0781-2266 HUMAN PRESCRIPTION DRUG Atomoxetine hydrochloride Atomoxetine hydrochloride CAPSULE ORAL 20101215 ANDA ANDA079018 Sandoz Inc ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0781-2271_ee885922-cc1f-4cf5-89ff-43714520d1fa 0781-2271 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Sandoz Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0781-2272_ee885922-cc1f-4cf5-89ff-43714520d1fa 0781-2272 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Sandoz Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0781-2273_ee885922-cc1f-4cf5-89ff-43714520d1fa 0781-2273 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Sandoz Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0781-2274_ee885922-cc1f-4cf5-89ff-43714520d1fa 0781-2274 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Sandoz Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0781-2277_ee885922-cc1f-4cf5-89ff-43714520d1fa 0781-2277 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Sandoz Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0781-2279_ee885922-cc1f-4cf5-89ff-43714520d1fa 0781-2279 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Sandoz Inc AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0781-2321_bd32527e-b2df-44ac-a6bb-21be96d47906 0781-2321 HUMAN PRESCRIPTION DRUG Aprepitant aprepitant CAPSULE ORAL 20161227 ANDA ANDA090999 Sandoz Inc APREPITANT 40 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 0781-2322_bd32527e-b2df-44ac-a6bb-21be96d47906 0781-2322 HUMAN PRESCRIPTION DRUG Aprepitant aprepitant CAPSULE ORAL 20161227 ANDA ANDA090999 Sandoz Inc APREPITANT 80 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 0781-2323_bd32527e-b2df-44ac-a6bb-21be96d47906 0781-2323 HUMAN PRESCRIPTION DRUG Aprepitant aprepitant CAPSULE ORAL 20161227 ANDA ANDA090999 Sandoz Inc APREPITANT 125 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 0781-2325_ccc1eb42-7478-4b16-b21b-7b7be3871172 0781-2325 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 19870429 20180630 ANDA ANDA070673 Sandoz Inc INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0781-2329_1a162e22-30bb-44c9-8e72-ac4413902b37 0781-2329 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Sandoz Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2335_1a162e22-30bb-44c9-8e72-ac4413902b37 0781-2335 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Sandoz Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2343_1a162e22-30bb-44c9-8e72-ac4413902b37 0781-2343 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Sandoz Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2352_1a162e22-30bb-44c9-8e72-ac4413902b37 0781-2352 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Sandoz Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2362_1f8983ce-71b8-4c62-830d-e4692ddededa 0781-2362 HUMAN PRESCRIPTION DRUG Methylphenidate methylphenidate CAPSULE, EXTENDED RELEASE ORAL 20151124 NDA AUTHORIZED GENERIC NDA021284 Sandoz Inc METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2363_1f8983ce-71b8-4c62-830d-e4692ddededa 0781-2363 HUMAN PRESCRIPTION DRUG Methylphenidate methylphenidate CAPSULE, EXTENDED RELEASE ORAL 20151124 NDA AUTHORIZED GENERIC NDA021284 Sandoz Inc METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2364_1f8983ce-71b8-4c62-830d-e4692ddededa 0781-2364 HUMAN PRESCRIPTION DRUG Methylphenidate methylphenidate CAPSULE, EXTENDED RELEASE ORAL 20151124 NDA AUTHORIZED GENERIC NDA021284 Sandoz Inc METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2368_1a162e22-30bb-44c9-8e72-ac4413902b37 0781-2368 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Sandoz Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2371_1a162e22-30bb-44c9-8e72-ac4413902b37 0781-2371 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Sandoz Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2452_d2349620-b581-47a0-83b8-75f21d6e6fa5 0781-2452 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 20180531 ANDA ANDA091022 Sandoz Inc DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0781-2453_d2349620-b581-47a0-83b8-75f21d6e6fa5 0781-2453 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 20180531 ANDA ANDA091022 Sandoz Inc DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0781-2454_d2349620-b581-47a0-83b8-75f21d6e6fa5 0781-2454 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 20180531 ANDA ANDA091022 Sandoz Inc DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0781-2455_d2349620-b581-47a0-83b8-75f21d6e6fa5 0781-2455 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 20180531 ANDA ANDA091022 Sandoz Inc DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0781-2456_d2349620-b581-47a0-83b8-75f21d6e6fa5 0781-2456 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 20180531 ANDA ANDA091022 Sandoz Inc DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0781-2457_d2349620-b581-47a0-83b8-75f21d6e6fa5 0781-2457 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 20180531 ANDA ANDA091022 Sandoz Inc DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 0781-2613_d1babc2f-36e2-4270-8904-e5a0817d94c7 0781-2613 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Sandoz Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-2614_3375f1a6-a261-4c5c-81ee-674a11cefaf8 0781-2614 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate rivastigmine tartrate CAPSULE ORAL 20000430 NDA AUTHORIZED GENERIC NDA020823 Sandoz Inc RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0781-2615_3375f1a6-a261-4c5c-81ee-674a11cefaf8 0781-2615 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate rivastigmine tartrate CAPSULE ORAL 20000430 NDA AUTHORIZED GENERIC NDA020823 Sandoz Inc RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0781-2616_3375f1a6-a261-4c5c-81ee-674a11cefaf8 0781-2616 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate rivastigmine tartrate CAPSULE ORAL 20000430 NDA AUTHORIZED GENERIC NDA020823 Sandoz Inc RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0781-2617_3375f1a6-a261-4c5c-81ee-674a11cefaf8 0781-2617 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate rivastigmine tartrate CAPSULE ORAL 20000430 NDA AUTHORIZED GENERIC NDA020823 Sandoz Inc RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0781-2672_5f87abb7-0e6d-6369-e053-2a91aa0a2411 0781-2672 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20120314 NDA AUTHORIZED GENERIC NDA021160 Sandoz Inc CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0781-2682_68da6c8c-251c-4250-8393-056caf78fc25 0781-2682 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141112 NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2683_68da6c8c-251c-4250-8393-056caf78fc25 0781-2683 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150203 NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2684_68da6c8c-251c-4250-8393-056caf78fc25 0781-2684 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140128 NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2685_68da6c8c-251c-4250-8393-056caf78fc25 0781-2685 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150622 NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2686_68da6c8c-251c-4250-8393-056caf78fc25 0781-2686 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170105 NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 25 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2687_68da6c8c-251c-4250-8393-056caf78fc25 0781-2687 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140102 NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2688_68da6c8c-251c-4250-8393-056caf78fc25 0781-2688 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170105 NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 35 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2689_68da6c8c-251c-4250-8393-056caf78fc25 0781-2689 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140304 NDA AUTHORIZED GENERIC NDA021802 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-2691_a750842d-b4f8-4569-9b94-e0520a4d21af 0781-2691 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021029 Sandoz Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0781-2692_a750842d-b4f8-4569-9b94-e0520a4d21af 0781-2692 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021029 Sandoz Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0781-2693_a750842d-b4f8-4569-9b94-e0520a4d21af 0781-2693 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021029 Sandoz Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0781-2694_a750842d-b4f8-4569-9b94-e0520a4d21af 0781-2694 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021029 Sandoz Inc. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0781-2695_a750842d-b4f8-4569-9b94-e0520a4d21af 0781-2695 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021029 Sandoz Inc. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0781-2696_a750842d-b4f8-4569-9b94-e0520a4d21af 0781-2696 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021029 Sandoz Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0781-2715_a8c9ccef-b3b6-4ba1-9dab-d889ec7a1f16 0781-2715 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19910731 ANDA ANDA073191 Sandoz Inc TRIAMTERENE; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-2785_e5e793a9-2a8e-4211-b3f7-a153eeeac896 0781-2785 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20030128 ANDA ANDA075757 Sandoz Inc OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0781-2790_e5e793a9-2a8e-4211-b3f7-a153eeeac896 0781-2790 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20030128 ANDA ANDA075757 Sandoz Inc OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0781-2809_bf271f49-af20-4edd-a0d6-f1555b59dbb9 0781-2809 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 19880419 20190831 ANDA ANDA071813 Sandoz Inc OXAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-2810_bf271f49-af20-4edd-a0d6-f1555b59dbb9 0781-2810 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 19880419 20190831 ANDA ANDA071756 Sandoz Inc OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-2811_bf271f49-af20-4edd-a0d6-f1555b59dbb9 0781-2811 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 19880419 20190831 ANDA ANDA071814 Sandoz Inc OXAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-2822_ccad95e7-6a38-4ea7-b3da-54e5a1573987 0781-2822 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20020129 ANDA ANDA075049 Sandoz Inc FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0781-2823_ccad95e7-6a38-4ea7-b3da-54e5a1573987 0781-2823 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20010802 ANDA ANDA075049 Sandoz Inc FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0781-2824_ccad95e7-6a38-4ea7-b3da-54e5a1573987 0781-2824 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20020129 ANDA ANDA075049 Sandoz Inc FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0781-2855_97c5cff1-e9a3-420d-a34c-118758ef2a14 0781-2855 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 19971022 ANDA ANDA074655 Sandoz Inc RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0781-2865_97c5cff1-e9a3-420d-a34c-118758ef2a14 0781-2865 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 19971022 ANDA ANDA074655 Sandoz Inc RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0781-3000_cfe3e636-9804-4240-a79d-d4e998e7efd0 0781-3000 HUMAN PRESCRIPTION DRUG MEROPENEM MEROPENEM INJECTION INTRAVENOUS 20160829 ANDA ANDA206086 Sandoz Inc MEROPENEM 500 mg/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 0781-3001_0684f2d9-9697-4134-aa35-ec180bdd790c 0781-3001 HUMAN PRESCRIPTION DRUG Omnitrope Somatropin INJECTION, SOLUTION SUBCUTANEOUS 20060530 NDA NDA021426 Sandoz Inc SOMATROPIN 5 mg/1.5mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] N 20181231 0781-3003_37418d42-f4fc-4f86-a9d2-4b33b85c4460 0781-3003 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20050503 ANDA ANDA077071 Sandoz Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 0781-3004_0684f2d9-9697-4134-aa35-ec180bdd790c 0781-3004 HUMAN PRESCRIPTION DRUG Omnitrope Somatropin INJECTION, SOLUTION SUBCUTANEOUS 20060530 NDA NDA021426 Sandoz Inc SOMATROPIN 10 mg/1.5mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] N 20181231 0781-3009_086a7742-5f8c-4127-a488-56a1cd245331 0781-3009 HUMAN PRESCRIPTION DRUG Anectine Succinylcholine Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 19520820 NDA NDA008453 Sandoz Inc SUCCINYLCHOLINE CHLORIDE 20 mg/mL Depolarizing Neuromuscular Blocker [EPC],Neuromuscular Depolarizing Blockade [PE] N 20181231 0781-3032_96a49628-ecc7-46d7-928e-d6494ea9387c 0781-3032 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060725 ANDA ANDA065241 Sandoz Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0781-3033_96a49628-ecc7-46d7-928e-d6494ea9387c 0781-3033 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060725 ANDA ANDA065241 Sandoz Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0781-3034_f5b7d78c-6e28-4ecb-ba35-1945ed0dfaf4 0781-3034 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and Sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060725 ANDA ANDA065240 Sandoz Inc AMPICILLIN SODIUM; SULBACTAM SODIUM 10; 5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 0781-3040_44da988e-5709-4647-a578-ad7935601c7e 0781-3040 HUMAN PRESCRIPTION DRUG Regonol Pyridostigmine Bromide INJECTION, SOLUTION INTRAVENOUS; PARENTERAL 20050510 NDA NDA017398 Sandoz Inc PYRIDOSTIGMINE BROMIDE 5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0781-3056_9305e334-9ab5-4db9-86b8-79854843b24a 0781-3056 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid INJECTION, SOLUTION INTRAMUSCULAR 20060119 ANDA ANDA040648 Sandoz Inc ISONIAZID 100 mg/mL Antimycobacterial [EPC] N 20181231 0781-3059_bf2bf5ec-3825-4f7a-91b3-d65e7e8087f6 0781-3059 HUMAN PRESCRIPTION DRUG Digoxin Digoxin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 20030821 ANDA ANDA040481 Sandoz Inc DIGOXIN 250 ug/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0781-3084_c5bf372c-d304-4300-9d94-1211cd723e96 0781-3084 HUMAN PRESCRIPTION DRUG Aristospan Triamcinolone Hexacetonide INJECTION, SUSPENSION INTRALESIONAL; PARENTERAL 19690729 NDA NDA016466 Sandoz Inc TRIAMCINOLONE HEXACETONIDE 5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-3085_ad853754-f9ab-493f-b13d-4e717be20d18 0781-3085 HUMAN PRESCRIPTION DRUG Aristospan Triamcinolone Hexacetonide INJECTION, SUSPENSION INTRA-ARTICULAR; PARENTERAL 19690729 NDA NDA016466 Sandoz Inc TRIAMCINOLONE HEXACETONIDE 20 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-3094_74fa731d-dde1-4036-850e-3464c9dd72be 0781-3094 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19861223 ANDA ANDA062737 Sandoz Inc OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3095_74fa731d-dde1-4036-850e-3464c9dd72be 0781-3095 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19861223 ANDA ANDA062737 Sandoz Inc OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3098_cfe3e636-9804-4240-a79d-d4e998e7efd0 0781-3098 HUMAN PRESCRIPTION DRUG MEROPENEM MEROPENEM INJECTION INTRAVENOUS 20160829 ANDA ANDA206086 Sandoz Inc MEROPENEM 1 g/30mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 0781-3099_85b9177b-c221-461a-8de8-60d3569bd0b1 0781-3099 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19760106 ANDA ANDA061490 Sandoz Inc OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3101_85b9177b-c221-461a-8de8-60d3569bd0b1 0781-3101 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19760106 ANDA ANDA061490 Sandoz Inc OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3103_1e53ce68-4344-4cc6-8297-234c478ed036 0781-3103 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19910509 ANDA ANDA061490 Sandoz Inc OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3110_47afd4c9-e18e-4d65-b894-9da8649a4db5 0781-3110 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-3113_47afd4c9-e18e-4d65-b894-9da8649a4db5 0781-3113 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-3114_47afd4c9-e18e-4d65-b894-9da8649a4db5 0781-3114 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20101021 ANDA ANDA065362 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-3124_f7176557-0f8e-4a45-8144-888f2bde4cc0 0781-3124 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz Inc NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3125_f7176557-0f8e-4a45-8144-888f2bde4cc0 0781-3125 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz Inc NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3126_236e71c3-5426-4dfc-9ea7-1f807da271ac 0781-3126 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170801 ANDA ANDA062527 Sandoz Inc NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3128_2c189773-4d43-41cb-aa3c-03836590c1a0 0781-3128 HUMAN PRESCRIPTION DRUG Nafcillin Sodium Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19861223 ANDA ANDA062732 Sandoz Inc NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3129_2c189773-4d43-41cb-aa3c-03836590c1a0 0781-3129 HUMAN PRESCRIPTION DRUG Nafcillin Sodium Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19861223 ANDA ANDA062732 Sandoz Inc NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3131_7b4e3280-2181-4cde-a5fa-e0caf53417a0 0781-3131 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; PARENTERAL; SOFT TISSUE 20090305 ANDA ANDA040794 Sandoz Inc METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-3132_7b4e3280-2181-4cde-a5fa-e0caf53417a0 0781-3132 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; PARENTERAL; SOFT TISSUE 20090305 ANDA ANDA040794 Sandoz Inc METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-3133_163bc9b9-b926-4437-8a0b-9d17fd30340d 0781-3133 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0781-3136_cf85fb08-0e09-4b6b-b151-7cb8b542d31d 0781-3136 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20090129 ANDA ANDA040719 Sandoz Inc METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-3137_cf85fb08-0e09-4b6b-b151-7cb8b542d31d 0781-3137 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20090129 ANDA ANDA040719 Sandoz Inc METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-3139_0b9599e8-9018-42ee-b247-e2a944c36510 0781-3139 HUMAN PRESCRIPTION DRUG Decitabine Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140828 ANDA ANDA202969 Sandoz Inc DECITABINE 50 mg/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0781-3140_b48c183c-69f9-411c-a27b-9e31b3876ede 0781-3140 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride Ropivacaine Hydrochloride INJECTION, SOLUTION PARENTERAL 20140724 ANDA ANDA078601 Sandoz Inc ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0781-3142_b48c183c-69f9-411c-a27b-9e31b3876ede 0781-3142 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride Ropivacaine Hydrochloride INJECTION, SOLUTION PARENTERAL 20140724 ANDA ANDA078601 Sandoz Inc ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 0781-3150_a82ebf4b-50fe-4bc5-8851-b3cf6d65a99b 0781-3150 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20120716 ANDA ANDA200154 Sandoz Inc CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20191231 0781-3152_31ff1ec2-1f50-4da7-947b-4a8d1803155b 0781-3152 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20120716 ANDA ANDA200159 Sandoz Inc CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0781-3153_a82ebf4b-50fe-4bc5-8851-b3cf6d65a99b 0781-3153 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20120716 ANDA ANDA200154 Sandoz Inc CISATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20191231 0781-3158_1a07a375-7456-4e00-befe-07aaf2cdb4a3 0781-3158 HUMAN PRESCRIPTION DRUG bivalirudin bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150615 NDA AUTHORIZED GENERIC NDA020873 Sandoz BIVALIRUDIN 250 mg/1 Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 0781-3159_fea67385-f97d-436b-8c37-d1603770ecae 0781-3159 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20111024 ANDA ANDA201588 Sandoz Inc OLANZAPINE 10 mg/2mL Atypical Antipsychotic [EPC] N 20181231 0781-3164_b02b276f-9007-4ec7-8bcd-40f14213d7f5 0781-3164 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19881021 NDA NDA019667 Sandoz Inc OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0781-3165_b02b276f-9007-4ec7-8bcd-40f14213d7f5 0781-3165 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19881021 NDA NDA019667 Sandoz Inc OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0781-3166_4e5348ae-d032-4eea-babc-2cc54c66616e 0781-3166 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140204 NDA AUTHORIZED GENERIC NDA019667 Sandoz Inc OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0781-3167_4e5348ae-d032-4eea-babc-2cc54c66616e 0781-3167 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140204 NDA AUTHORIZED GENERIC NDA019667 Sandoz Inc OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0781-3168_4e5348ae-d032-4eea-babc-2cc54c66616e 0781-3168 HUMAN PRESCRIPTION DRUG Octreotide Acetate Octreotide Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140204 NDA AUTHORIZED GENERIC NDA019667 Sandoz Inc OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 0781-3169_4ff04938-34fd-4f5c-8d3f-8a6158b9b804 0781-3169 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTION, SOLUTION SUBCUTANEOUS 20120112 NDA NDA020080 Sandoz Inc SUMATRIPTAN SUCCINATE 4 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-3170_4ff04938-34fd-4f5c-8d3f-8a6158b9b804 0781-3170 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTION, SOLUTION SUBCUTANEOUS 20120112 NDA NDA020080 Sandoz Inc SUMATRIPTAN SUCCINATE 4 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-3172_4ff04938-34fd-4f5c-8d3f-8a6158b9b804 0781-3172 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTION, SOLUTION SUBCUTANEOUS 20120112 NDA NDA020080 Sandoz Inc SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-3173_4ff04938-34fd-4f5c-8d3f-8a6158b9b804 0781-3173 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTION, SOLUTION SUBCUTANEOUS 20080909 NDA NDA020080 Sandoz Inc SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-3174_4ff04938-34fd-4f5c-8d3f-8a6158b9b804 0781-3174 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTION, SOLUTION SUBCUTANEOUS 20080909 NDA NDA020080 Sandoz Inc SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-3177_f855e6f8-527b-4534-94f8-a97ceafdaa31 0781-3177 HUMAN PRESCRIPTION DRUG Ceftazidime Ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080515 ANDA ANDA062640 Sandoz Inc CEFTAZIDIME 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3178_f855e6f8-527b-4534-94f8-a97ceafdaa31 0781-3178 HUMAN PRESCRIPTION DRUG Ceftazidime Ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080515 ANDA ANDA062640 Sandoz Inc CEFTAZIDIME 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3179_5248955e-1665-4c30-bf54-01eb19b5c11a 0781-3179 HUMAN PRESCRIPTION DRUG Ceftazidime Ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080515 ANDA ANDA062640 Sandoz Inc CEFTAZIDIME 200 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3182_a306cd11-9acf-45f1-91ec-9fef2b08fdb1 0781-3182 HUMAN PRESCRIPTION DRUG fomepizole fomepizole INJECTION, SOLUTION INTRAVENOUS 20080306 ANDA ANDA078537 Sandoz Inc. FOMEPIZOLE 1 g/mL Antidote [EPC] E 20171231 0781-3187_a02b7202-b017-44a4-9b7c-ba78a52fe201 0781-3187 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100427 ANDA ANDA090250 Sandoz Inc VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0781-3188_a02b7202-b017-44a4-9b7c-ba78a52fe201 0781-3188 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100427 ANDA ANDA090250 Sandoz Inc VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 0781-3201_646a224b-3380-4e5c-bad8-b70e04e66359 0781-3201 HUMAN PRESCRIPTION DRUG Levoleucovorin Levoleucovorin INJECTION, SOLUTION INTRAVENOUS 20150423 ANDA ANDA203563 Sandoz Inc LEVOLEUCOVORIN CALCIUM PENTAHYDRATE 175 mg/17.5mL N 20181231 0781-3204_547aacb1-dd90-4934-80ff-6b3db422175a 0781-3204 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20091117 ANDA ANDA090125 Sandoz Inc. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 0781-3206_857d6f5d-d928-4420-9ad6-33c3b3e4e9a0 0781-3206 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3207_857d6f5d-d928-4420-9ad6-33c3b3e4e9a0 0781-3207 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3208_857d6f5d-d928-4420-9ad6-33c3b3e4e9a0 0781-3208 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3209_857d6f5d-d928-4420-9ad6-33c3b3e4e9a0 0781-3209 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3210_9a4bda77-9964-47df-b082-bbe96bfaba2e 0781-3210 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050517 ANDA ANDA065168 Sandoz Inc CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3220_3399d4f1-9b1f-4f77-bfde-19a428071629 0781-3220 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20081205 ANDA ANDA079195 Sandoz Inc ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0781-3222_18bf4c29-e238-45aa-b976-d2d600fb0609 0781-3222 HUMAN PRESCRIPTION DRUG Cefepime Hydrochloride Cefepime Hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080501 ANDA ANDA065441 Sandoz Inc CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3223_18bf4c29-e238-45aa-b976-d2d600fb0609 0781-3223 HUMAN PRESCRIPTION DRUG Cefepime Hydrochloride Cefepime Hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080501 ANDA ANDA065441 Sandoz Inc CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3224_163bc9b9-b926-4437-8a0b-9d17fd30340d 0781-3224 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0781-3233_603ab419-0614-188c-e053-2a91aa0a6d36 0781-3233 HUMAN PRESCRIPTION DRUG Cyclophosphamide cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20141031 ANDA ANDA204555 Sandoz Inc. CYCLOPHOSPHAMIDE 500 mg/25mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0781-3234_c8eaa1ab-c679-47fc-a8d7-cb3280843df6 0781-3234 HUMAN PRESCRIPTION DRUG Glatopa Glatiramer Acetate INJECTION, SOLUTION SUBCUTANEOUS 20150618 ANDA ANDA090218 Sandoz Inc GLATIRAMER ACETATE 20 mg/mL N 20181231 0781-3239_ad3c44ea-73db-44d7-b11f-d1fa82d968e3 0781-3239 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION INTRAVENOUS 20080324 ANDA ANDA078252 Sandoz Inc CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0781-3240_ad3c44ea-73db-44d7-b11f-d1fa82d968e3 0781-3240 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION INTRAVENOUS 20080324 ANDA ANDA078252 Sandoz Inc CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0781-3243_8be94992-efea-4654-ae46-0f0e0b1517fd 0781-3243 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRABURSAL; INTRADERMAL; INTRALESIONAL 20090527 ANDA ANDA090166 Sandoz Inc TRIAMCINOLONE ACETONIDE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-3244_603ab419-0614-188c-e053-2a91aa0a6d36 0781-3244 HUMAN PRESCRIPTION DRUG Cyclophosphamide cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20141031 ANDA ANDA204555 Sandoz Inc. CYCLOPHOSPHAMIDE 1 g/50mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0781-3245_14a166c0-4823-4157-8652-829a5e5b4880 0781-3245 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20090527 ANDA ANDA090164 Sandoz Inc TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-3253_c62745c5-18d0-4638-b7e0-0b3fd8eec0a0 0781-3253 HUMAN PRESCRIPTION DRUG Azacitidine azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20130916 NDA AUTHORIZED GENERIC NDA050794 Sandoz Inc AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0781-3255_603ab419-0614-188c-e053-2a91aa0a6d36 0781-3255 HUMAN PRESCRIPTION DRUG Cyclophosphamide cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20141031 ANDA ANDA204555 Sandoz Inc. CYCLOPHOSPHAMIDE 2 g/100mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 0781-3265_50365fe4-70db-487f-8259-42b54e85a2a8 0781-3265 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110329 ANDA ANDA091201 Sandoz Inc MEROPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 0781-3267_50365fe4-70db-487f-8259-42b54e85a2a8 0781-3267 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110329 ANDA ANDA091201 Sandoz Inc MEROPENEM 1 g/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 0781-3269_c8af7bb5-41da-4f8c-8acd-f489892a0d72 0781-3269 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION INTRAVENOUS 20171001 ANDA ANDA209784 Sandoz Inc EPHEDRINE SULFATE 50 mg/mL alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE] N 20181231 0781-3285_1ae496ee-dc66-4bc0-9676-f8c47f7044e6 0781-3285 HUMAN PRESCRIPTION DRUG Argatroban Argatroban SOLUTION INTRAVENOUS 20110509 NDA NDA022485 Sandoz Inc ARGATROBAN 125 mg/125mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 0781-3288_53ba38fd-a222-46f9-a105-91caeffde015 0781-3288 HUMAN PRESCRIPTION DRUG Clindamycin in 5 Percent Dextrose Clindamycin in 5 Percent Dextrose INJECTION, SOLUTION INTRAVENOUS 20130207 ANDA ANDA201692 Sandoz Inc CLINDAMYCIN 6 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0781-3289_53ba38fd-a222-46f9-a105-91caeffde015 0781-3289 HUMAN PRESCRIPTION DRUG Clindamycin in 5 Percent Dextrose Clindamycin in 5 Percent Dextrose INJECTION, SOLUTION INTRAVENOUS 20130207 ANDA ANDA201692 Sandoz Inc CLINDAMYCIN 12 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0781-3290_53ba38fd-a222-46f9-a105-91caeffde015 0781-3290 HUMAN PRESCRIPTION DRUG Clindamycin in 5 Percent Dextrose Clindamycin in 5 Percent Dextrose INJECTION, SOLUTION INTRAVENOUS 20130207 ANDA ANDA201692 Sandoz Inc CLINDAMYCIN 18 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0781-3297_e3c1f948-e7ce-4dfa-af3c-3a7f11eed6db 0781-3297 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20161114 ANDA ANDA091465 Sandoz Inc DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 0781-3305_ff1d9e28-4bb1-485b-b860-446e715019fb 0781-3305 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol INJECTION, SOLUTION INTRAVENOUS 20140204 ANDA ANDA200926 Sandoz Inc DOXERCALCIFEROL 4 ug/2mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 0781-3314_b7e24fcd-1045-468d-a096-8e7288ba0ccd 0781-3314 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20110906 NDA NDA022434 Sandoz Inc ARGATROBAN 1 mg/mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 0781-3315_8f671d16-0a9e-4594-a23d-85d140cb0169 0781-3315 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20150301 ANDA ANDA078817 Sandoz Inc OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0781-3317_8f671d16-0a9e-4594-a23d-85d140cb0169 0781-3317 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20150301 ANDA ANDA078817 Sandoz Inc OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0781-3327_6bfbbf70-320b-4f30-a80b-cbe3ca936dfd 0781-3327 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110608 ANDA ANDA091682 Sandoz Inc HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0781-3331_6bfbbf70-320b-4f30-a80b-cbe3ca936dfd 0781-3331 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110608 ANDA ANDA091682 Sandoz Inc HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0781-3332_6bfbbf70-320b-4f30-a80b-cbe3ca936dfd 0781-3332 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110608 ANDA ANDA091659 Sandoz Inc HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0781-3333_6bfbbf70-320b-4f30-a80b-cbe3ca936dfd 0781-3333 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110608 ANDA ANDA201002 Sandoz Inc HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 0781-3341_ef4ad79a-dcfc-49b0-a3b6-aebe76d5b5a6 0781-3341 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110707 ANDA ANDA090343 Sandoz Inc LEVOFLOXACIN 5 mg/mL N 20181231 0781-3342_ef4ad79a-dcfc-49b0-a3b6-aebe76d5b5a6 0781-3342 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110707 ANDA ANDA090343 Sandoz Inc LEVOFLOXACIN 5 mg/mL N 20181231 0781-3343_ef4ad79a-dcfc-49b0-a3b6-aebe76d5b5a6 0781-3343 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110707 ANDA ANDA090343 Sandoz Inc LEVOFLOXACIN 5 mg/mL N 20181231 0781-3344_822b585b-1db5-42d9-91e3-799693efa647 0781-3344 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110531 ANDA ANDA065523 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-3350_822b585b-1db5-42d9-91e3-799693efa647 0781-3350 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110531 ANDA ANDA065523 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-3356_163bc9b9-b926-4437-8a0b-9d17fd30340d 0781-3356 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0781-3367_822b585b-1db5-42d9-91e3-799693efa647 0781-3367 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110531 ANDA ANDA065523 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-3400_981188dd-d167-431f-9b14-6788f2f9f52c 0781-3400 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 125 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3402_981188dd-d167-431f-9b14-6788f2f9f52c 0781-3402 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3404_981188dd-d167-431f-9b14-6788f2f9f52c 0781-3404 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3407_981188dd-d167-431f-9b14-6788f2f9f52c 0781-3407 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3408_981188dd-d167-431f-9b14-6788f2f9f52c 0781-3408 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3409_c4113510-3bc7-40f2-9c5d-e643047de7ae 0781-3409 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 10 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3411_a1e5d29f-111e-4a44-addf-beeb6ea81711 0781-3411 HUMAN PRESCRIPTION DRUG Anectine Succinylcholine Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 20170622 NDA NDA008453 Sandoz Inc SUCCINYLCHOLINE CHLORIDE 20 mg/mL Depolarizing Neuromuscular Blocker [EPC],Neuromuscular Depolarizing Blockade [PE] N 20181231 0781-3412_a7edb8dc-7b03-497e-a9d9-394a8351a743 0781-3412 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870219 ANDA ANDA062738 Sandoz Inc AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3413_a7edb8dc-7b03-497e-a9d9-394a8351a743 0781-3413 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870219 ANDA ANDA062738 Sandoz Inc AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-3416_2f27d3db-46eb-4305-9cc6-2342c500248f 0781-3416 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120530 ANDA ANDA090862 Sandoz Inc VORICONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0781-3428_163bc9b9-b926-4437-8a0b-9d17fd30340d 0781-3428 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0781-3431_1f776b99-eae6-4b8d-87d6-ffe6ca08fe19 0781-3431 HUMAN PRESCRIPTION DRUG Linezolid Linezolid INJECTION, SOLUTION INTRAVENOUS 20160615 ANDA ANDA200904 Sandoz Inc LINEZOLID 200 mg/100mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0781-3433_1f776b99-eae6-4b8d-87d6-ffe6ca08fe19 0781-3433 HUMAN PRESCRIPTION DRUG Linezolid Linezolid INJECTION, SOLUTION INTRAVENOUS 20160615 ANDA ANDA200904 Sandoz Inc LINEZOLID 600 mg/300mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 0781-3440_1342169c-e214-4f22-8363-1fd45b85d1e8 0781-3440 HUMAN PRESCRIPTION DRUG Cosyntropin Cosyntropin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120629 ANDA ANDA202147 Sandoz Inc COSYNTROPIN .25 mg/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] N 20181231 0781-3450_d5ad4e20-6c86-4fac-8289-c66f8710d519 0781-3450 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 19881209 ANDA ANDA062831 Sandoz Inc CEFAZOLIN SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3451_d5ad4e20-6c86-4fac-8289-c66f8710d519 0781-3451 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 19881209 ANDA ANDA062831 Sandoz Inc CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3452_9a90853b-349e-4a62-a047-fb9190f35845 0781-3452 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; PARENTERAL 19881209 ANDA ANDA062831 Sandoz Inc CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-3481_c09b6ab2-c8d4-43e3-a4fe-fa3297e18d84 0781-3481 HUMAN PRESCRIPTION DRUG Tigecycline Tigecycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; PARENTERAL 20171129 ANDA ANDA091620 Sandoz Inc TIGECYCLINE 50 mg/10mL Tetracycline-class Antibacterial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0781-3500_163bc9b9-b926-4437-8a0b-9d17fd30340d 0781-3500 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0781-3612_163bc9b9-b926-4437-8a0b-9d17fd30340d 0781-3612 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0781-3655_163bc9b9-b926-4437-8a0b-9d17fd30340d 0781-3655 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Sandoz Inc ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20181231 0781-4003_8540b082-d9cd-4821-96ae-de91471acd05 0781-4003 HUMAN PRESCRIPTION DRUG Leuprolide Acetate Leuprolide Acetate KIT 19980804 ANDA ANDA074728 Sandoz Inc N 20181231 0781-4004_0684f2d9-9697-4134-aa35-ec180bdd790c 0781-4004 HUMAN PRESCRIPTION DRUG Omnitrope Somatropin KIT 20060530 NDA NDA021426 Sandoz Inc N 20181231 0781-4040_b0406e06-b384-4f8a-9c2c-e8dba2389c42 0781-4040 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine KIT 20100105 ANDA ANDA078645 Sandoz Inc N 20181231 0781-4054_9a14ae1c-e049-4a5f-938c-5216679afe3b 0781-4054 HUMAN PRESCRIPTION DRUG Lansoprazole, Amoxicillin and Clarithromycin Lansoprazole, Amoxicillin and Clarithromycin KIT 20140304 ANDA ANDA202588 Sandoz Inc N 20181231 0781-4058_13f99f65-1c63-a7fd-3bfa-de2b5ee2891e 0781-4058 HUMAN PRESCRIPTION DRUG Estarylla Norgestimate and ethinyl estradiol KIT 20130201 ANDA ANDA090794 Sandoz Inc N 20181231 0781-4060_bcf47853-6415-b85e-f240-d5be6e5b522d 0781-4060 HUMAN PRESCRIPTION DRUG Tri-Estarylla norgestimate and ethinyl estradiol KIT 20130201 ANDA ANDA090793 Sandoz Inc N 20191231 0781-4062_09688713-1ca7-e96d-9d8b-96541a58a494 0781-4062 HUMAN PRESCRIPTION DRUG Tri-Lo- Estarylla norgestimate and ethinyl estradiol KIT 20151125 ANDA ANDA091232 Sandoz Inc N 20181231 0781-4063_bd32527e-b2df-44ac-a6bb-21be96d47906 0781-4063 HUMAN PRESCRIPTION DRUG Aprepitant aprepitant KIT 20161227 ANDA ANDA090999 Sandoz Inc N 20181231 0781-4066_be86c7c8-a5d7-4392-b288-cbe506c4caf3 0781-4066 HUMAN PRESCRIPTION DRUG Isibloom desogestrel and ethinyl estradiol KIT 20170120 ANDA ANDA202789 Sandoz Inc N 20181231 0781-4075_82b8fe04-f493-4ae0-a6e8-95bffdd252d7 0781-4075 HUMAN PRESCRIPTION DRUG Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium KIT 20161012 NDA AUTHORIZED GENERIC NDA022532 Sandoz Inc N 20181231 0781-4103_98ca88c2-f409-4460-be59-d0457734b797 0781-4103 HUMAN PRESCRIPTION DRUG Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium KIT 20150801 NDA AUTHORIZED GENERIC NDA022574 Sandoz Inc N 20181231 0781-4110_68a028c5-88b5-4551-9902-c07e422c7148 0781-4110 HUMAN PRESCRIPTION DRUG Estradiol Valerate and Estradiol Valerate/Dienogest estradiol valerate and estradiol valerate/dienogest KIT 20150805 NDA AUTHORIZED GENERIC NDA022252 Sandoz Inc N 20181231 0781-5017_731f86ee-7751-4dfb-aad6-b367385f3397 0781-5017 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19981120 ANDA ANDA075229 Sandoz Inc DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0781-5020_073eea09-4ffe-41a7-86d8-808b556e389e 0781-5020 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960719 ANDA ANDA040101 Sandoz Inc PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-5021_073eea09-4ffe-41a7-86d8-808b556e389e 0781-5021 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960719 ANDA ANDA040101 Sandoz Inc PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-5022_9744dc0d-5f6f-4388-8ace-dab5d09738f7 0781-5022 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040194 Sandoz Inc METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-5043_f38043a1-48b4-4949-9243-a211523d5449 0781-5043 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20051114 ANDA ANDA065235 Sandoz Inc CEFPROZIL 250 mg/1 N 20181231 0781-5044_f38043a1-48b4-4949-9243-a211523d5449 0781-5044 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20051114 ANDA ANDA065235 Sandoz Inc CEFPROZIL 500 mg/1 N 20181231 0781-5060_d1babc2f-36e2-4270-8904-e5a0817d94c7 0781-5060 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20050713 ANDA ANDA065228 Sandoz Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-5061_d1babc2f-36e2-4270-8904-e5a0817d94c7 0781-5061 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20050713 ANDA ANDA065228 Sandoz Inc AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-5067_63fd0329-cf95-45a9-a515-3cb454fdbeb7 0781-5067 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 20170420 ANDA ANDA072011 Sandoz Inc TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5068_63fd0329-cf95-45a9-a515-3cb454fdbeb7 0781-5068 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 20170420 ANDA ANDA073281 Sandoz Inc TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5077_c6f7e888-750f-4f2f-a1b1-06687e138376 0781-5077 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030121 ANDA ANDA075209 Sandoz Inc LORATADINE 10 mg/1 N 20181231 0781-5122_b0406e06-b384-4f8a-9c2c-e8dba2389c42 0781-5122 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100105 ANDA ANDA078645 Sandoz Inc LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0781-5123_b0406e06-b384-4f8a-9c2c-e8dba2389c42 0781-5123 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100105 ANDA ANDA078645 Sandoz Inc LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0781-5124_b0406e06-b384-4f8a-9c2c-e8dba2389c42 0781-5124 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100105 ANDA ANDA078645 Sandoz Inc LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0781-5125_b0406e06-b384-4f8a-9c2c-e8dba2389c42 0781-5125 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100105 ANDA ANDA078645 Sandoz Inc LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0781-5148_2a5d1f34-37aa-49d2-8f28-73acc5589df9 0781-5148 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20131227 ANDA ANDA078555 Sandoz Inc REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0781-5149_2a5d1f34-37aa-49d2-8f28-73acc5589df9 0781-5149 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA078555 Sandoz Inc REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0781-5150_2a5d1f34-37aa-49d2-8f28-73acc5589df9 0781-5150 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA078555 Sandoz Inc REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 0781-5169_273517ba-6758-412f-854b-a6f724bcd00d 0781-5169 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080312 ANDA ANDA077475 Sandoz Inc BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0781-5175_7ae6a7c8-eeb5-46ad-97a1-6fdca35b8e0e 0781-5175 HUMAN PRESCRIPTION DRUG Mycophenolate mofetil Mycophenolate mofetil TABLET ORAL 20081015 ANDA ANDA065451 Sandoz Inc MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 0781-5177_206ad017-3b96-4732-9366-1906c9dbf957 0781-5177 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20061003 ANDA ANDA077743 Sandoz Inc RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 0781-5180_4b6aba6e-bc0c-22c7-e054-00144ff8d46c 0781-5180 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0781-5181_4b6aba6e-bc0c-22c7-e054-00144ff8d46c 0781-5181 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0781-5182_4b6aba6e-bc0c-22c7-e054-00144ff8d46c 0781-5182 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0781-5183_4b6aba6e-bc0c-22c7-e054-00144ff8d46c 0781-5183 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0781-5184_4b6aba6e-bc0c-22c7-e054-00144ff8d46c 0781-5184 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0781-5185_4b6aba6e-bc0c-22c7-e054-00144ff8d46c 0781-5185 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0781-5186_4b6aba6e-bc0c-22c7-e054-00144ff8d46c 0781-5186 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0781-5187_4b6aba6e-bc0c-22c7-e054-00144ff8d46c 0781-5187 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0781-5188_4b6aba6e-bc0c-22c7-e054-00144ff8d46c 0781-5188 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0781-5189_4b6aba6e-bc0c-22c7-e054-00144ff8d46c 0781-5189 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0781-5190_4b6aba6e-bc0c-22c7-e054-00144ff8d46c 0781-5190 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 300 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0781-5191_4b6aba6e-bc0c-22c7-e054-00144ff8d46c 0781-5191 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Sandoz Inc. LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 0781-5204_a126bf64-2caa-4ca3-8b33-7e848ab5f5a7 0781-5204 HUMAN PRESCRIPTION DRUG Losartan potassium and hydrochlorothiazide Losartan potassium and hydrochlorothiazide tablets TABLET, FILM COATED ORAL 20101006 ANDA ANDA077948 Sandoz Inc LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5206_a126bf64-2caa-4ca3-8b33-7e848ab5f5a7 0781-5206 HUMAN PRESCRIPTION DRUG Losartan potassium and hydrochlorothiazide Losartan potassium and hydrochlorothiazide tablets TABLET, FILM COATED ORAL 20101006 ANDA ANDA077948 Sandoz Inc LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5207_a126bf64-2caa-4ca3-8b33-7e848ab5f5a7 0781-5207 HUMAN PRESCRIPTION DRUG Losartan potassium and hydrochlorothiazide Losartan potassium and hydrochlorothiazide tablets TABLET, FILM COATED ORAL 20101006 ANDA ANDA077948 Sandoz Inc LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5208_06ce1f4b-35ee-450f-bca3-b62f3bb66f04 0781-5208 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET ORAL 20100524 ANDA ANDA077478 Sandoz Inc VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0781-5209_06ce1f4b-35ee-450f-bca3-b62f3bb66f04 0781-5209 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET ORAL 20100524 ANDA ANDA077478 Sandoz Inc VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0781-5218_b29100b1-2813-4e85-ba28-d99df85aa522 0781-5218 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20150624 ANDA ANDA072099 Sandoz Inc DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0781-5220_14beac7f-849f-4b5c-8ec4-dbca0979bd08 0781-5220 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 Sandoz Inc ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0781-5221_68418350-9717-4fc2-9499-1ea016b557c2 0781-5221 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Sandoz Inc CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0781-5222_68418350-9717-4fc2-9499-1ea016b557c2 0781-5222 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Sandoz Inc CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0781-5223_68418350-9717-4fc2-9499-1ea016b557c2 0781-5223 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Sandoz Inc CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0781-5224_68418350-9717-4fc2-9499-1ea016b557c2 0781-5224 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Sandoz Inc CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 0781-5225_14beac7f-849f-4b5c-8ec4-dbca0979bd08 0781-5225 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073025 Sandoz Inc ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0781-5226_7692869b-8464-4927-9dbb-0bebfec2a9ea 0781-5226 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20130701 ANDA ANDA078364 Sandoz Inc DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0781-5229_14beac7f-849f-4b5c-8ec4-dbca0979bd08 0781-5229 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073026 Sandoz Inc ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0781-5231_56c39347-1ea1-4306-bd14-dda785df7143 0781-5231 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20140428 ANDA ANDA076397 Sandoz Inc PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5232_56c39347-1ea1-4306-bd14-dda785df7143 0781-5232 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20140428 ANDA ANDA076397 Sandoz Inc PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5234_56c39347-1ea1-4306-bd14-dda785df7143 0781-5234 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20140428 ANDA ANDA076397 Sandoz Inc PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5235_56c39347-1ea1-4306-bd14-dda785df7143 0781-5235 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20140728 ANDA ANDA077491 Sandoz Inc PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5238_dfabe7b1-6c43-40e7-9355-ab034c323d23 0781-5238 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA078050 Sandoz Inc ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0781-5239_dfabe7b1-6c43-40e7-9355-ab034c323d23 0781-5239 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070813 ANDA ANDA078050 Sandoz Inc ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 0781-5248_57121d70-d083-4862-b4e5-c69e12067089 0781-5248 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0781-5249_57121d70-d083-4862-b4e5-c69e12067089 0781-5249 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0781-5250_57121d70-d083-4862-b4e5-c69e12067089 0781-5250 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0781-5251_57121d70-d083-4862-b4e5-c69e12067089 0781-5251 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0781-5252_57121d70-d083-4862-b4e5-c69e12067089 0781-5252 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0781-5274_a2416636-d799-4ff1-9aa6-00190fd5a276 0781-5274 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET ORAL 20110531 ANDA ANDA090290 Sandoz Inc DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0781-5275_a2416636-d799-4ff1-9aa6-00190fd5a276 0781-5275 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET ORAL 20110531 ANDA ANDA090290 Sandoz Inc DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0781-5276_9abde4ce-52bd-4546-81cb-2370a24416ad 0781-5276 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110510 ANDA ANDA091198 Sandoz Inc DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0781-5277_9abde4ce-52bd-4546-81cb-2370a24416ad 0781-5277 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110510 ANDA ANDA091198 Sandoz Inc DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0781-5281_57121d70-d083-4862-b4e5-c69e12067089 0781-5281 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090190 Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0781-5283_8f721b0d-4ed3-4c25-9666-250d890e665b 0781-5283 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20080214 ANDA ANDA078692 Sandoz Inc CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 0781-5284_5a63af45-f72c-406d-a061-a0b56ca4bffc 0781-5284 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20080214 ANDA ANDA078692 Sandoz Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0781-5310_2aeebcaf-1679-4e0b-bcac-fd2ea343a93c 0781-5310 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091222 ANDA ANDA078116 Sandoz Inc RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5311_2aeebcaf-1679-4e0b-bcac-fd2ea343a93c 0781-5311 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091222 ANDA ANDA078116 Sandoz Inc RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5312_2aeebcaf-1679-4e0b-bcac-fd2ea343a93c 0781-5312 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091222 ANDA ANDA078116 Sandoz Inc RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5313_2aeebcaf-1679-4e0b-bcac-fd2ea343a93c 0781-5313 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091222 ANDA ANDA078116 Sandoz Inc RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5314_2aeebcaf-1679-4e0b-bcac-fd2ea343a93c 0781-5314 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091222 ANDA ANDA078116 Sandoz Inc RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5315_fe92ee30-b8d9-4dc2-bfd5-d0cff00ea1a6 0781-5315 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Sandoz Inc ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0781-5316_fe92ee30-b8d9-4dc2-bfd5-d0cff00ea1a6 0781-5316 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Sandoz Inc ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0781-5317_8b3efa35-9526-4235-81c4-af92f230c44c 0781-5317 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20070423 ANDA ANDA077322 Sandoz Inc ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0781-5318_8b3efa35-9526-4235-81c4-af92f230c44c 0781-5318 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20070423 ANDA ANDA077322 Sandoz Inc ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0781-5325_d8b85ef8-f954-4239-9548-273eaf1efea7 0781-5325 HUMAN PRESCRIPTION DRUG Bromocriptine mesylate Bromocriptine mesylate TABLET ORAL 19980113 ANDA ANDA074631 Sandoz Inc BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 0781-5342_53226d56-80c7-401d-858d-03f2fb20cfeb 0781-5342 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5343_53226d56-80c7-401d-858d-03f2fb20cfeb 0781-5343 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5344_53226d56-80c7-401d-858d-03f2fb20cfeb 0781-5344 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5345_53226d56-80c7-401d-858d-03f2fb20cfeb 0781-5345 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5346_53226d56-80c7-401d-858d-03f2fb20cfeb 0781-5346 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5347_53226d56-80c7-401d-858d-03f2fb20cfeb 0781-5347 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5348_53226d56-80c7-401d-858d-03f2fb20cfeb 0781-5348 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 Sandoz Inc QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5356_b97c8f13-43ad-4130-b6ec-e945cb77d55d 0781-5356 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20100628 ANDA ANDA079007 Sandoz Inc ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0781-5370_c184692f-4afa-47b9-80d3-481fde50a4fa 0781-5370 HUMAN PRESCRIPTION DRUG FLUVASTATIN SODIUM ER fluvastatin sodium TABLET, EXTENDED RELEASE ORAL 20151016 NDA AUTHORIZED GENERIC NDA021192 Sandoz Inc FLUVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5371_1e9f779d-5859-4b11-9b7a-d3efcbe83693 0781-5371 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Sandoz Inc LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-5372_376e33b8-7ee0-4571-804d-9aaaa7b020e8 0781-5372 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20150206 ANDA ANDA203867 Sandoz Inc TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5374_376e33b8-7ee0-4571-804d-9aaaa7b020e8 0781-5374 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20150206 ANDA ANDA203867 Sandoz Inc TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5377_1e9f779d-5859-4b11-9b7a-d3efcbe83693 0781-5377 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Sandoz Inc LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-5378_376e33b8-7ee0-4571-804d-9aaaa7b020e8 0781-5378 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20150206 ANDA ANDA203867 Sandoz Inc TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5379_1e9f779d-5859-4b11-9b7a-d3efcbe83693 0781-5379 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070108 ANDA ANDA071141 Sandoz Inc LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-5381_aff83d49-3d8b-4dba-8b85-77e172bb2fc6 0781-5381 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120529 ANDA ANDA077575 Sandoz Inc ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5382_aff83d49-3d8b-4dba-8b85-77e172bb2fc6 0781-5382 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120529 ANDA ANDA077575 Sandoz Inc ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5384_aff83d49-3d8b-4dba-8b85-77e172bb2fc6 0781-5384 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120529 ANDA ANDA077575 Sandoz Inc ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5385_feb5a83b-3eda-493a-b8ad-f162bf9f5cf3 0781-5385 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090813 ANDA ANDA090422 Sandoz Inc MINOCYCLINE HYDROCHLORIDE 45 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0781-5386_feb5a83b-3eda-493a-b8ad-f162bf9f5cf3 0781-5386 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090813 ANDA ANDA090422 Sandoz Inc MINOCYCLINE HYDROCHLORIDE 90 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0781-5387_feb5a83b-3eda-493a-b8ad-f162bf9f5cf3 0781-5387 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090813 ANDA ANDA090422 Sandoz Inc MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0781-5388_aff83d49-3d8b-4dba-8b85-77e172bb2fc6 0781-5388 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120529 ANDA ANDA077575 Sandoz Inc ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5400_861f5730-9b6a-4d8a-9258-dee552dc3fc0 0781-5400 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079171 Sandoz Inc ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5401_861f5730-9b6a-4d8a-9258-dee552dc3fc0 0781-5401 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079171 Sandoz Inc ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5402_861f5730-9b6a-4d8a-9258-dee552dc3fc0 0781-5402 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079171 Sandoz Inc ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5403_861f5730-9b6a-4d8a-9258-dee552dc3fc0 0781-5403 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079171 Sandoz Inc ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0781-5404_4dd897c7-5492-4d21-be33-2a930821fa17 0781-5404 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Sandoz Inc LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-5405_b4a06de6-f837-43a8-ae7a-aadb38dd2a7d 0781-5405 HUMAN PRESCRIPTION DRUG Cafergot Ergotamine Tartrate and Caffeine TABLET, FILM COATED ORAL 19820101 ANDA ANDA084294 Sandoz Inc ERGOTAMINE TARTRATE; CAFFEINE 1; 100 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0781-5406_4dd897c7-5492-4d21-be33-2a930821fa17 0781-5406 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Sandoz Inc LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-5408_4dd897c7-5492-4d21-be33-2a930821fa17 0781-5408 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070108 ANDA ANDA071141 Sandoz Inc LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-5420_d11097ba-c30d-4015-a0b5-56ef3abe3cbb 0781-5420 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20130301 ANDA ANDA078670 Sandoz Inc PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 0781-5421_d11097ba-c30d-4015-a0b5-56ef3abe3cbb 0781-5421 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20130301 ANDA ANDA078670 Sandoz Inc PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 0781-5422_d11097ba-c30d-4015-a0b5-56ef3abe3cbb 0781-5422 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20130301 ANDA ANDA078670 Sandoz Inc PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 0781-5425_f1d08f03-3125-48cb-ac9c-05a36111f9a5 0781-5425 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130702 ANDA ANDA078739 Sandoz Inc RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-5426_f1d08f03-3125-48cb-ac9c-05a36111f9a5 0781-5426 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130702 ANDA ANDA078739 Sandoz Inc RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-5438_fa487191-4b42-4a56-97f6-4a7cafdc6e93 0781-5438 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil TABLET, FILM COATED ORAL 20080528 ANDA ANDA065462 Sandoz Inc CEFPODOXIME PROXETIL 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-5439_fa487191-4b42-4a56-97f6-4a7cafdc6e93 0781-5439 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil TABLET, FILM COATED ORAL 20080528 ANDA ANDA065462 Sandoz Inc CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-5451_b0ea8a87-f0b7-4bdb-bd80-c1c40d5a213d 0781-5451 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20150603 ANDA ANDA202568 Sandoz Inc GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0781-5452_b0ea8a87-f0b7-4bdb-bd80-c1c40d5a213d 0781-5452 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20150603 ANDA ANDA202568 Sandoz Inc GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0781-5456_b0ea8a87-f0b7-4bdb-bd80-c1c40d5a213d 0781-5456 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20150603 ANDA ANDA202568 Sandoz Inc GUANFACINE HYDROCHLORIDE 3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0781-5457_b0ea8a87-f0b7-4bdb-bd80-c1c40d5a213d 0781-5457 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20150603 ANDA ANDA202568 Sandoz Inc GUANFACINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0781-5485_2978b28c-91e1-4b17-9670-7b03717c1711 0781-5485 HUMAN PRESCRIPTION DRUG Rizatriptan benzoate Rizatriptan benzoate TABLET ORAL 20130211 ANDA ANDA079230 Sandoz Inc RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-5486_2978b28c-91e1-4b17-9670-7b03717c1711 0781-5486 HUMAN PRESCRIPTION DRUG Rizatriptan benzoate Rizatriptan benzoate TABLET ORAL 20130211 ANDA ANDA079230 Sandoz Inc RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-5503_66581aea-f38f-4733-af7d-6fadc1e91ce1 0781-5503 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20161125 ANDA ANDA201991 Sandoz Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0781-5514_27a575d3-76fb-4ade-bcac-7ced178643bb 0781-5514 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET ORAL 20130807 ANDA ANDA091592 Sandoz Inc GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 0781-5515_27a575d3-76fb-4ade-bcac-7ced178643bb 0781-5515 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET ORAL 20130807 ANDA ANDA091592 Sandoz Inc GRISEOFULVIN 500 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 0781-5526_4dda1b06-d3c1-44f4-afb1-b0e31db9e497 0781-5526 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET, COATED ORAL 20100707 ANDA ANDA090288 Sandoz Inc NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-5527_4dda1b06-d3c1-44f4-afb1-b0e31db9e497 0781-5527 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET, COATED ORAL 20100707 ANDA ANDA090288 Sandoz Inc NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-5528_b044a501-44cf-4f1f-b757-0efc30b33d65 0781-5528 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride (XL) Bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20180108 ANDA ANDA208652 Sandoz Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0781-5529_b044a501-44cf-4f1f-b757-0efc30b33d65 0781-5529 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride (XL) Bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20180108 ANDA ANDA208652 Sandoz Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0781-5554_62226384-2c01-4333-9682-248cb3d4b364 0781-5554 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, CHEWABLE ORAL 20120803 ANDA ANDA091414 Sandoz Inc MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0781-5555_62226384-2c01-4333-9682-248cb3d4b364 0781-5555 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, CHEWABLE ORAL 20120803 ANDA ANDA091414 Sandoz Inc MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0781-5560_62226384-2c01-4333-9682-248cb3d4b364 0781-5560 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, FILM COATED ORAL 20120803 ANDA ANDA200889 Sandoz Inc MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 0781-5567_5efa6cc2-1504-4538-98dd-c94d89511767 0781-5567 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20160701 ANDA ANDA074979 Sandoz Inc CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-5569_5efa6cc2-1504-4538-98dd-c94d89511767 0781-5569 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20160701 ANDA ANDA074979 Sandoz Inc CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0781-5575_8bb672a1-c915-41de-9e8c-d607130ec111 0781-5575 HUMAN PRESCRIPTION DRUG Vienva TM Levonorgestrel and Ethinyl Estradiol KIT 20151105 ANDA ANDA201088 Sandoz Inc N 20181231 0781-5578_b5bbb386-1430-4283-934d-d4bdf4268c65 0781-5578 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20140604 NDA AUTHORIZED GENERIC NDA020796 Sandoz Inc ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0781-5583_9b631985-047c-45dd-8d8d-6be86cead9c1 0781-5583 HUMAN PRESCRIPTION DRUG ALTAVERA Levonorgestrel and Ethinyl Estradiol KIT 20100803 ANDA ANDA079102 Sandoz Inc N 20181231 0781-5584_b1f388b2-d62d-1bf2-97ca-638e655bc00b 0781-5584 HUMAN PRESCRIPTION DRUG Introvale Levonorgestrel and Ethinyl Estradiol KIT 20100927 ANDA ANDA079064 Sandoz Inc N 20181231 0781-5607_442afae9-22f0-42f6-b108-c5b711f84eb2 0781-5607 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140707 NDA AUTHORIZED GENERIC NDA021283 Sandoz Inc VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5608_442afae9-22f0-42f6-b108-c5b711f84eb2 0781-5608 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140707 NDA AUTHORIZED GENERIC NDA021283 Sandoz Inc VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5613_4b00e6cb-fd33-4466-8935-f74079b52ee3 0781-5613 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa, and Entacapone Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED ORAL 20140618 NDA AUTHORIZED GENERIC NDA021485 Sandoz Inc CARBIDOPA; LEVODOPA; ENTACAPONE 12.5; 50; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0781-5615_118b6546-95d2-44af-abc3-d4c411bc89e9 0781-5615 HUMAN PRESCRIPTION DRUG AMLODIPINE AND VALSARTAN amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20150330 NDA AUTHORIZED GENERIC NDA021990 Sandoz Inc AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5618_442afae9-22f0-42f6-b108-c5b711f84eb2 0781-5618 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140707 NDA AUTHORIZED GENERIC NDA021283 Sandoz Inc VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5619_442afae9-22f0-42f6-b108-c5b711f84eb2 0781-5619 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140707 NDA AUTHORIZED GENERIC NDA021283 Sandoz Inc VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5625_4b00e6cb-fd33-4466-8935-f74079b52ee3 0781-5625 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa, and Entacapone Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED ORAL 20140618 NDA AUTHORIZED GENERIC NDA021485 Sandoz Inc CARBIDOPA; LEVODOPA; ENTACAPONE 18.75; 75; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0781-5626_0bb13b52-8c46-449d-b0a3-ad45ab410f87 0781-5626 HUMAN PRESCRIPTION DRUG Pioglitazone and metformin Pioglitazone and metformin TABLET, FILM COATED ORAL 20130502 ANDA ANDA091273 Sandoz Inc PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 500 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0781-5627_0bb13b52-8c46-449d-b0a3-ad45ab410f87 0781-5627 HUMAN PRESCRIPTION DRUG Pioglitazone and metformin Pioglitazone and metformin TABLET, FILM COATED ORAL 20130502 ANDA ANDA091273 Sandoz Inc PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 850 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0781-5628_118b6546-95d2-44af-abc3-d4c411bc89e9 0781-5628 HUMAN PRESCRIPTION DRUG AMLODIPINE AND VALSARTAN amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20150330 NDA AUTHORIZED GENERIC NDA021990 Sandoz Inc AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5634_5badfb65-09f0-46fa-a5d1-0c0ead0f7c3b 0781-5634 HUMAN PRESCRIPTION DRUG Pioglitazone hydrochloride and glimepiride Pioglitazone hydrochloride and glimepiride TABLET ORAL 20130108 ANDA ANDA201049 Sandoz Inc PIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE 30; 2 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0781-5635_5badfb65-09f0-46fa-a5d1-0c0ead0f7c3b 0781-5635 HUMAN PRESCRIPTION DRUG Pioglitazone hydrochloride and glimepiride Pioglitazone hydrochloride and glimepiride TABLET ORAL 20130108 ANDA ANDA201049 Sandoz Inc PIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE 30; 4 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0781-5637_4b00e6cb-fd33-4466-8935-f74079b52ee3 0781-5637 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa, and Entacapone Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED ORAL 20140618 NDA AUTHORIZED GENERIC NDA021485 Sandoz Inc CARBIDOPA; LEVODOPA; ENTACAPONE 25; 100; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0781-5639_118b6546-95d2-44af-abc3-d4c411bc89e9 0781-5639 HUMAN PRESCRIPTION DRUG AMLODIPINE AND VALSARTAN amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20150330 NDA AUTHORIZED GENERIC NDA021990 Sandoz Inc AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5641_4b00e6cb-fd33-4466-8935-f74079b52ee3 0781-5641 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa, and Entacapone Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED ORAL 20140618 NDA AUTHORIZED GENERIC NDA021485 Sandoz Inc CARBIDOPA; LEVODOPA; ENTACAPONE 31.25; 125; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0781-5643_118b6546-95d2-44af-abc3-d4c411bc89e9 0781-5643 HUMAN PRESCRIPTION DRUG AMLODIPINE AND VALSARTAN amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20150330 NDA AUTHORIZED GENERIC NDA021990 Sandoz Inc AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5654_4b00e6cb-fd33-4466-8935-f74079b52ee3 0781-5654 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa, and Entacapone Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED ORAL 20140618 NDA AUTHORIZED GENERIC NDA021485 Sandoz Inc CARBIDOPA; LEVODOPA; ENTACAPONE 37.5; 150; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0781-5656_5f692967-f3c5-6a3e-7c8e-e434e2917013 0781-5656 HUMAN PRESCRIPTION DRUG Loryna drospirenone and ethinyl estradiol KIT 20110328 ANDA ANDA079221 Sandoz Inc N 20181231 0781-5658_79314f7d-bacb-1d17-a3a8-79698b5c4b45 0781-5658 HUMAN PRESCRIPTION DRUG Syeda Drospirenone and Ethinyl Estradiol KIT 20110328 ANDA ANDA090114 Sandoz Inc N 20181231 0781-5667_a88549fb-2311-47a3-bf85-3006e5c56274 0781-5667 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20111212 ANDA ANDA200265 Sandoz Inc VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0781-5668_a88549fb-2311-47a3-bf85-3006e5c56274 0781-5668 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20111212 ANDA ANDA200265 Sandoz Inc VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0781-5669_4b00e6cb-fd33-4466-8935-f74079b52ee3 0781-5669 HUMAN PRESCRIPTION DRUG Carbidopa, Levodopa, and Entacapone Carbidopa, Levodopa, and Entacapone TABLET, FILM COATED ORAL 20140618 NDA AUTHORIZED GENERIC NDA021485 Sandoz Inc CARBIDOPA; LEVODOPA; ENTACAPONE 50; 200; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 0781-5676_5dce18f6-7f59-4726-9971-d3fa6e459959 0781-5676 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20150427 NDA AUTHORIZED GENERIC NDA021278 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-5689_5dce18f6-7f59-4726-9971-d3fa6e459959 0781-5689 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20150427 NDA AUTHORIZED GENERIC NDA021278 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-5690_ebcb6655-fd60-4099-8099-be911c5b32ae 0781-5690 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20170612 ANDA ANDA203931 Sandoz Inc EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 0781-5691_5dce18f6-7f59-4726-9971-d3fa6e459959 0781-5691 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20150427 NDA AUTHORIZED GENERIC NDA021278 Sandoz Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 0781-5700_a3d9f659-cac0-47fc-bc25-02fd881edf4a 0781-5700 HUMAN PRESCRIPTION DRUG Losartan potassium losartan potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA077424 Sandoz Inc LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5701_a3d9f659-cac0-47fc-bc25-02fd881edf4a 0781-5701 HUMAN PRESCRIPTION DRUG Losartan potassium losartan potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA077424 Sandoz Inc LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5702_a3d9f659-cac0-47fc-bc25-02fd881edf4a 0781-5702 HUMAN PRESCRIPTION DRUG Losartan potassium losartan potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA077424 Sandoz Inc LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5703_2daac07a-7b11-4e90-bc56-20a4f54fbbf8 0781-5703 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141008 NDA AUTHORIZED GENERIC NDA022272 Sandoz Inc OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0781-5710_c26a060d-7de5-40b2-8469-f26713ee18f5 0781-5710 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 Sandoz Inc POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0781-5720_c26a060d-7de5-40b2-8469-f26713ee18f5 0781-5720 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 Sandoz Inc POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0781-5726_2daac07a-7b11-4e90-bc56-20a4f54fbbf8 0781-5726 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141008 NDA AUTHORIZED GENERIC NDA022272 Sandoz Inc OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0781-5748_880fd193-8fdc-4ba8-9491-0033cb2b7442 0781-5748 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19551231 NDA AUTHORIZED GENERIC NDA010187 Sandoz Inc METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 0781-5749_880fd193-8fdc-4ba8-9491-0033cb2b7442 0781-5749 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19551231 NDA AUTHORIZED GENERIC NDA010187 Sandoz Inc METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 0781-5753_880fd193-8fdc-4ba8-9491-0033cb2b7442 0781-5753 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19551231 NDA AUTHORIZED GENERIC NDA010187 Sandoz Inc METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 0781-5754_880fd193-8fdc-4ba8-9491-0033cb2b7442 0781-5754 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride SR methylphenidate hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19820331 NDA AUTHORIZED GENERIC NDA018029 Sandoz Inc METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 0781-5756_dd311bf0-c5c8-4f0b-9f8f-e855bb32a71e 0781-5756 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 NDA AUTHORIZED GENERIC NDA022314 Sandoz Inc AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5760_dd311bf0-c5c8-4f0b-9f8f-e855bb32a71e 0781-5760 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 NDA AUTHORIZED GENERIC NDA022314 Sandoz Inc AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5767_2daac07a-7b11-4e90-bc56-20a4f54fbbf8 0781-5767 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141008 NDA AUTHORIZED GENERIC NDA022272 Sandoz Inc OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0781-5771_dd311bf0-c5c8-4f0b-9f8f-e855bb32a71e 0781-5771 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 NDA AUTHORIZED GENERIC NDA022314 Sandoz Inc AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5776_7faa040d-c9c0-4c69-a9c2-ad1236b9abc8 0781-5776 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20170302 ANDA ANDA065211 Sandoz Inc AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0781-5780_be3b49e8-16da-42e0-b2c8-8fd6119f34c7 0781-5780 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120901 ANDA ANDA201047 Sandoz Inc ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0781-5782_be3b49e8-16da-42e0-b2c8-8fd6119f34c7 0781-5782 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120901 ANDA ANDA201047 Sandoz Inc ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0781-5784_be3b49e8-16da-42e0-b2c8-8fd6119f34c7 0781-5784 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120901 ANDA ANDA201047 Sandoz Inc ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0781-5785_2daac07a-7b11-4e90-bc56-20a4f54fbbf8 0781-5785 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141008 NDA AUTHORIZED GENERIC NDA022272 Sandoz Inc OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0781-5786_be3b49e8-16da-42e0-b2c8-8fd6119f34c7 0781-5786 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120901 ANDA ANDA201047 Sandoz Inc ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0781-5787_dd311bf0-c5c8-4f0b-9f8f-e855bb32a71e 0781-5787 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 NDA AUTHORIZED GENERIC NDA022314 Sandoz Inc AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5788_be3b49e8-16da-42e0-b2c8-8fd6119f34c7 0781-5788 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120901 ANDA ANDA201047 Sandoz Inc ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0781-5789_7faa040d-c9c0-4c69-a9c2-ad1236b9abc8 0781-5789 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20170302 ANDA ANDA065212 Sandoz Inc AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0781-5790_c5561390-7952-4383-9f66-7c3e13e7edff 0781-5790 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Sandoz Inc LEVOFLOXACIN 250 mg/1 N 20181231 0781-5791_c5561390-7952-4383-9f66-7c3e13e7edff 0781-5791 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Sandoz Inc LEVOFLOXACIN 500 mg/1 N 20181231 0781-5792_c5561390-7952-4383-9f66-7c3e13e7edff 0781-5792 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Sandoz Inc LEVOFLOXACIN 750 mg/1 N 20181231 0781-5793_79e1cfff-c1f6-4651-8d05-38110ec6abeb 0781-5793 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20170302 ANDA ANDA065209 Sandoz Inc AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 0781-5794_dd311bf0-c5c8-4f0b-9f8f-e855bb32a71e 0781-5794 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 NDA AUTHORIZED GENERIC NDA022314 Sandoz Inc AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 320; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5805_ea4a85dd-1f98-48ee-98fe-1f4a09340cbd 0781-5805 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Sandoz Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5806_ea4a85dd-1f98-48ee-98fe-1f4a09340cbd 0781-5806 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Sandoz Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5807_ea4a85dd-1f98-48ee-98fe-1f4a09340cbd 0781-5807 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Sandoz Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5816_83c4f278-a699-41b6-b372-63072cdbc202 0781-5816 HUMAN PRESCRIPTION DRUG losartan potassium and hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Sandoz Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5817_83c4f278-a699-41b6-b372-63072cdbc202 0781-5817 HUMAN PRESCRIPTION DRUG losartan potassium and hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Sandoz Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5818_83c4f278-a699-41b6-b372-63072cdbc202 0781-5818 HUMAN PRESCRIPTION DRUG losartan potassium and hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Sandoz Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5893_15c8f77a-8ebb-40c3-9b55-ef29bb7b71f5 0781-5893 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET, EXTENDED RELEASE ORAL 20140415 ANDA ANDA203411 Sandoz Inc NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 0781-5913_9f26839e-6422-4e34-aaa2-7ebf4dbe1cfa 0781-5913 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA083386 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-5914_9f26839e-6422-4e34-aaa2-7ebf4dbe1cfa 0781-5914 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084112 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-5915_9f26839e-6422-4e34-aaa2-7ebf4dbe1cfa 0781-5915 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084113 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-5916_9f26839e-6422-4e34-aaa2-7ebf4dbe1cfa 0781-5916 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084114 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-5917_9f26839e-6422-4e34-aaa2-7ebf4dbe1cfa 0781-5917 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084115 Sandoz Inc CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0781-5936_1893fdc0-7e0c-434a-b813-6414bc8fcf23 0781-5936 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 ANDA ANDA078702 Sandoz Inc CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5937_1893fdc0-7e0c-434a-b813-6414bc8fcf23 0781-5937 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 ANDA ANDA078702 Sandoz Inc CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5938_1893fdc0-7e0c-434a-b813-6414bc8fcf23 0781-5938 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 ANDA ANDA078702 Sandoz Inc CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5939_1893fdc0-7e0c-434a-b813-6414bc8fcf23 0781-5939 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 ANDA ANDA078702 Sandoz Inc CANDESARTAN CILEXETIL 32 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0781-5948_ff7a21b8-e6b1-4111-a48f-143877db39eb 0781-5948 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Sandoz Inc VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5949_ff7a21b8-e6b1-4111-a48f-143877db39eb 0781-5949 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Sandoz Inc VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5950_ff7a21b8-e6b1-4111-a48f-143877db39eb 0781-5950 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Sandoz Inc VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5951_ff7a21b8-e6b1-4111-a48f-143877db39eb 0781-5951 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Sandoz Inc VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5952_ff7a21b8-e6b1-4111-a48f-143877db39eb 0781-5952 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Sandoz Inc VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0781-5986_cc5c3255-e6a7-4d01-8817-e0b32f4c41ce 0781-5986 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 19960325 NDA AUTHORIZED GENERIC NDA020234 Sandoz Inc CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0781-5987_cc5c3255-e6a7-4d01-8817-e0b32f4c41ce 0781-5987 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 19960325 NDA AUTHORIZED GENERIC NDA020234 Sandoz Inc CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0781-5988_cc5c3255-e6a7-4d01-8817-e0b32f4c41ce 0781-5988 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 19960325 NDA AUTHORIZED GENERIC NDA020234 Sandoz Inc CARBAMAZEPINE 400 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0781-5989_48997fa9-26aa-ead4-f4bb-ac370b9bfc55 0781-5989 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 20160506 NDA NDA019758 Sandoz Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-5992_48997fa9-26aa-ead4-f4bb-ac370b9bfc55 0781-5992 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 20160506 NDA NDA019758 Sandoz Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0781-6022_5ccc8cfa-42c2-4e3f-bc42-086c8b046c1b 0781-6022 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin FOR SUSPENSION ORAL 20070904 ANDA ANDA065283 Sandoz Inc CLARITHROMYCIN 125 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0781-6023_5ccc8cfa-42c2-4e3f-bc42-086c8b046c1b 0781-6023 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin FOR SUSPENSION ORAL 20070904 ANDA ANDA065283 Sandoz Inc CLARITHROMYCIN 250 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0781-6039_d1babc2f-36e2-4270-8904-e5a0817d94c7 0781-6039 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065387 Sandoz Inc AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-6041_d1babc2f-36e2-4270-8904-e5a0817d94c7 0781-6041 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065387 Sandoz Inc AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-6077_eb667482-22de-4e79-b155-c4fb36b7e6a9 0781-6077 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070406 ANDA ANDA065337 Sandoz Inc CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-6078_eb667482-22de-4e79-b155-c4fb36b7e6a9 0781-6078 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070406 ANDA ANDA065337 Sandoz Inc CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-6087_c08234ca-78f9-4e97-a4d4-0fbc4fd45bd1 0781-6087 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SYRUP TOPICAL 20111025 20201025 ANDA ANDA090054 Sandoz Inc. RANITIDINE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 0781-6102_2b1119d6-06a8-4e5f-a577-a0a3cf2b5f88 0781-6102 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20020605 ANDA ANDA065066 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-6104_2b1119d6-06a8-4e5f-a577-a0a3cf2b5f88 0781-6104 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20020605 ANDA ANDA065066 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-6135_fd0c7ac8-c4d3-417c-9b08-0d7c511d2f1a 0781-6135 HUMAN PRESCRIPTION DRUG Penicillin G Potassium Penicillin G Potassium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010830 ANDA ANDA065079 Sandoz Inc PENICILLIN G POTASSIUM 5000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-6136_fd0c7ac8-c4d3-417c-9b08-0d7c511d2f1a 0781-6136 HUMAN PRESCRIPTION DRUG Penicillin G Potassium Penicillin G Potassium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010830 ANDA ANDA065079 Sandoz Inc PENICILLIN G POTASSIUM 20000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-6139_fe790217-fbaa-4bdd-8548-6857f0bb8453 0781-6139 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20070813 ANDA ANDA065358 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-6153_5eb23c35-8871-43b6-8d5f-6e3239a665a7 0781-6153 HUMAN PRESCRIPTION DRUG Penicillin G Sodium Penicillin G Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010226 ANDA ANDA065068 Sandoz Inc PENICILLIN G SODIUM 5000000 [USP'U]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-6156_d1babc2f-36e2-4270-8904-e5a0817d94c7 0781-6156 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065378 Sandoz Inc AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-6157_d1babc2f-36e2-4270-8904-e5a0817d94c7 0781-6157 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065378 Sandoz Inc AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-6160_4f42748c-a03f-31b6-e054-00144ff8d46c 0781-6160 HUMAN PRESCRIPTION DRUG Sevoflurane Sevoflurane LIQUID RESPIRATORY (INHALATION) 20170125 ANDA ANDA203793 Sandoz Inc. SEVOFLURANE 250 mL/250mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 0781-6168_75ef1f0b-f03b-49e3-aeaf-209e8848ddd3 0781-6168 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20090625 ANDA ANDA090031 Sandoz Inc CEFPODOXIME PROXETIL 50 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-6169_75ef1f0b-f03b-49e3-aeaf-209e8848ddd3 0781-6169 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20090625 ANDA ANDA090031 Sandoz Inc CEFPODOXIME PROXETIL 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-6202_f38043a1-48b4-4949-9243-a211523d5449 0781-6202 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20051205 ANDA ANDA065257 Sandoz Inc CEFPROZIL 125 mg/5mL N 20181231 0781-6203_f38043a1-48b4-4949-9243-a211523d5449 0781-6203 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20051205 ANDA ANDA065257 Sandoz Inc CEFPROZIL 250 mg/5mL N 20181231 0781-6206_56915d23-20c4-46bc-9832-cf56186bf006 0781-6206 HUMAN PRESCRIPTION DRUG Bimatoprost Bimatoprost SOLUTION/ DROPS OPHTHALMIC 20161206 ANDA ANDA202719 Sandoz Inc BIMATOPROST .3 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 0781-6270_e3595f5a-dcea-4580-955c-e0dacef9d478 0781-6270 HUMAN PRESCRIPTION DRUG Oxcarbazepine oxcarbazepine SUSPENSION ORAL 20010530 NDA AUTHORIZED GENERIC NDA021285 Sandoz Inc OXCARBAZEPINE 60 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0781-6320_99e9e62b-9796-42ec-8f69-551dabf92ec1 0781-6320 HUMAN PRESCRIPTION DRUG calcitonin salmon calcitonin salmon SPRAY, METERED NASAL 19950801 NDA AUTHORIZED GENERIC NDA020313 Sandoz Inc CALCITONIN SALMON 200 [iU]/1 Calcitonin [Chemical/Ingredient],Calcitonin [EPC] N 20181231 0781-6355_45d004ce-a813-4c68-b805-edd708bf028d 0781-6355 HUMAN PRESCRIPTION DRUG Mometasone Furoate Monohydrate Mometasone Furoate Monohydrate SPRAY, METERED NASAL 20160325 NDA AUTHORIZED GENERIC NDA020762 Sandoz Inc. MOMETASONE FUROATE MONOHYDRATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-6523_8610b426-8a9c-411f-97ae-37bd91bf260c 0781-6523 HUMAN PRESCRIPTION DRUG SUMATRIPTAN sumatriptan SPRAY NASAL 20080911 NDA NDA020626 Sandoz Inc SUMATRIPTAN 20 mg/100uL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-6524_8610b426-8a9c-411f-97ae-37bd91bf260c 0781-6524 HUMAN PRESCRIPTION DRUG SUMATRIPTAN sumatriptan SPRAY NASAL 20080911 NDA NDA020626 Sandoz Inc SUMATRIPTAN 5 mg/100uL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 0781-7054_4c96eef7-1b1a-4458-afa2-4e817e483b9f 0781-7054 HUMAN PRESCRIPTION DRUG Erythromycin and Benzoyl Peroxide Erythromycin and Benzoyl Peroxide KIT TOPICAL 20040329 ANDA ANDA065112 Sandoz Inc. N 20181231 0781-7077_5f77ff7b-f6b5-4bfd-919b-c8949aa2e1f8 0781-7077 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL VAGINAL 20061031 ANDA ANDA077264 Sandoz Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0781-7080_efb30dd0-e2de-4a31-af82-7a0484d137b4 0781-7080 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20130701 ANDA ANDA090903 Sandoz Inc. METRONIDAZOLE 10 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 0781-7090_1924ecb0-b146-4a23-ba62-4035f01970f5 0781-7090 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20051104 ANDA ANDA076942 Sandoz Inc. KETOCONAZOLE 20.5 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 0781-7094_4c96eef7-1b1a-4458-afa2-4e817e483b9f 0781-7094 HUMAN PRESCRIPTION DRUG Erythromycin and Benzoyl Peroxide Erythromycin and Benzoyl Peroxide KIT TOPICAL 20040329 ANDA ANDA065112 Sandoz Inc. N 20181231 0781-7117_0339e6c2-c245-4b9e-8a20-9dbf1b4542b5 0781-7117 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene CREAM TOPICAL 20120727 ANDA ANDA200935 Sandoz Inc. CALCIPOTRIENE .05 mg/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 0781-7129_c4da6de7-9ab1-4fcf-88f3-fe785019e6e7 0781-7129 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20141222 NDA AUTHORIZED GENERIC NDA020538 Sandoz Inc ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0781-7135_fc88791b-24da-48a4-85f5-93a8af3d0b51 0781-7135 HUMAN PRESCRIPTION DRUG Moxifloxacin Ophthalmic Solution moxifloxacin hydrochloride SOLUTION/ DROPS OPHTHALMIC 20030507 NDA AUTHORIZED GENERIC NDA021598 Sandoz Inc MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0781-7137_60a57065-4617-42e6-9d96-342abb2d4851 0781-7137 HUMAN PRESCRIPTION DRUG clobetasol propionate clobetasol propionate SHAMPOO TOPICAL 20111222 NDA AUTHORIZED GENERIC NDA021644 Sandoz Inc. CLOBETASOL PROPIONATE .05 g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-7138_c4da6de7-9ab1-4fcf-88f3-fe785019e6e7 0781-7138 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20141222 NDA AUTHORIZED GENERIC NDA020538 Sandoz Inc ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0781-7142_aca56cb3-c5c6-4b21-b9ed-6c9ae012831e 0781-7142 HUMAN PRESCRIPTION DRUG Adapalene Adapalene GEL TOPICAL 20140428 ANDA ANDA200298 Sandoz Inc. ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 0781-7144_c4da6de7-9ab1-4fcf-88f3-fe785019e6e7 0781-7144 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20141222 NDA AUTHORIZED GENERIC NDA020538 Sandoz Inc ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0781-7146_305bb6c8-61ad-41db-8086-d60792c8ea68 0781-7146 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20130520 ANDA ANDA202496 Sandoz Inc. IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 3 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0781-7155_5fb1a243-8c4d-d584-e053-2991aa0ae1cb 0781-7155 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20110817 ANDA ANDA077839 Sandoz Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 0781-7156_c4da6de7-9ab1-4fcf-88f3-fe785019e6e7 0781-7156 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20141222 NDA AUTHORIZED GENERIC NDA020538 Sandoz Inc ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0781-7157_a76b5f61-64c0-4a1c-85a4-a7f743fb3250 0781-7157 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110901 ANDA ANDA075693 Sandoz Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0781-7161_04dccfaa-3487-42f7-93bd-b4e4dc72b9a2 0781-7161 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl Peroxide GEL TOPICAL 20160825 ANDA ANDA203688 Sandoz Inc. CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE 12; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0781-7165_64689b6b-b529-4a3d-926d-28b6b56b3f35 0781-7165 HUMAN PRESCRIPTION DRUG CALCIPOTRIENE 0.005% AND BETAMETHASONE DIPROPIONATE 0.064% calcipotriene 0.005% and betamethasone dipropionate 0.064% OINTMENT TOPICAL 20140331 ANDA ANDA201615 Sandoz Inc. CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE 50; .5 ug/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 0781-7167_c4da6de7-9ab1-4fcf-88f3-fe785019e6e7 0781-7167 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20141222 NDA AUTHORIZED GENERIC NDA020538 Sandoz Inc ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 0781-7171_b5fe420f-f859-45ed-84e2-24038bed3b7f 0781-7171 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION ORAL 20140709 NDA AUTHORIZED GENERIC NDA050753 Sandoz Inc TOBRAMYCIN 300 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 0781-7240_f1e19f5f-d358-4fc4-9179-0f62cfadb268 0781-7240 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Sandoz,Inc. FENTANYL 12.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0781-7241_f1e19f5f-d358-4fc4-9179-0f62cfadb268 0781-7241 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Sandoz,Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0781-7242_f1e19f5f-d358-4fc4-9179-0f62cfadb268 0781-7242 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Sandoz,Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0781-7243_f1e19f5f-d358-4fc4-9179-0f62cfadb268 0781-7243 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Sandoz,Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0781-7244_f1e19f5f-d358-4fc4-9179-0f62cfadb268 0781-7244 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Sandoz,Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0781-7263_899a8816-fbb5-46b9-9b02-db8d48c43f2f 0781-7263 HUMAN PRESCRIPTION DRUG Clindamycin and Benzoyl Peroxide Clindamycin and Benzoyl Peroxide KIT 20170815 ANDA ANDA204087 Sandoz Inc. N 20181231 0781-7275_899a8816-fbb5-46b9-9b02-db8d48c43f2f 0781-7275 HUMAN PRESCRIPTION DRUG Clindamycin and Benzoyl Peroxide Clindamycin and Benzoyl Peroxide KIT TOPICAL 20170815 ANDA ANDA204087 Sandoz Inc. N 20181231 0781-7287_899a8816-fbb5-46b9-9b02-db8d48c43f2f 0781-7287 HUMAN PRESCRIPTION DRUG Clindamycin and Benzoyl Peroxide Clindamycin and Benzoyl Peroxide KIT TOPICAL 20170815 ANDA ANDA204087 Sandoz Inc. N 20181231 0781-7291_899a8816-fbb5-46b9-9b02-db8d48c43f2f 0781-7291 HUMAN PRESCRIPTION DRUG Clindamycin and Benzoyl Peroxide Clindamycin and Benzoyl Peroxide KIT TOPICAL 20170815 ANDA ANDA204087 Sandoz Inc. N 20181231 0781-7304_92a58ebb-748d-49f4-bf11-ecbcf5424152 0781-7304 HUMAN PRESCRIPTION DRUG Rivastigmine rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20150902 NDA AUTHORIZED GENERIC NDA022083 Sandoz Inc RIVASTIGMINE 4.6 mg/24h Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0781-7309_92a58ebb-748d-49f4-bf11-ecbcf5424152 0781-7309 HUMAN PRESCRIPTION DRUG Rivastigmine rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20150902 NDA AUTHORIZED GENERIC NDA022083 Sandoz Inc RIVASTIGMINE 9.5 mg/24h Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0781-7313_92a58ebb-748d-49f4-bf11-ecbcf5424152 0781-7313 HUMAN PRESCRIPTION DRUG Rivastigmine rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20150902 NDA AUTHORIZED GENERIC NDA022083 Sandoz Inc RIVASTIGMINE 13.3 mg/24h Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0781-7515_9034b788-36de-4714-9614-aef02afed5a9 0781-7515 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20150724 ANDA ANDA201966 Sandoz Inc BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-7516_9034b788-36de-4714-9614-aef02afed5a9 0781-7516 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20150724 ANDA ANDA201966 Sandoz Inc BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-7517_9034b788-36de-4714-9614-aef02afed5a9 0781-7517 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20150724 ANDA ANDA201966 Sandoz Inc BUDESONIDE 1 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0781-8029_b34d3a28-1b4a-4c8f-bafe-fdc534702e88 0781-8029 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161201 NDA AUTHORIZED GENERIC NDA021875 Sandoz Inc. ARMODAFINIL 50 mg/1 CIV N 20181231 0781-8037_b34d3a28-1b4a-4c8f-bafe-fdc534702e88 0781-8037 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161201 NDA AUTHORIZED GENERIC NDA021875 Sandoz Inc. ARMODAFINIL 150 mg/1 CIV N 20181231 0781-8045_b34d3a28-1b4a-4c8f-bafe-fdc534702e88 0781-8045 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161201 NDA AUTHORIZED GENERIC NDA021875 Sandoz Inc. ARMODAFINIL 200 mg/1 CIV N 20181231 0781-8052_d1c80fe3-a933-4221-ac8f-7bd399ee7e47 0781-8052 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20160701 ANDA ANDA074477 SANDOZ INC. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 0781-8053_b34d3a28-1b4a-4c8f-bafe-fdc534702e88 0781-8053 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161201 NDA AUTHORIZED GENERIC NDA021875 Sandoz Inc. ARMODAFINIL 250 mg/1 CIV N 20181231 0781-8061_d1c80fe3-a933-4221-ac8f-7bd399ee7e47 0781-8061 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20160701 ANDA ANDA074477 SANDOZ INC. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 0781-8075_d1c80fe3-a933-4221-ac8f-7bd399ee7e47 0781-8075 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20160701 ANDA ANDA074477 SANDOZ INC. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 0781-8080_d1c80fe3-a933-4221-ac8f-7bd399ee7e47 0781-8080 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20160701 ANDA ANDA074477 SANDOZ INC. CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 0781-8940_40e63e07-1f05-4dd9-af32-d40cbfb463e5 0781-8940 HUMAN PRESCRIPTION DRUG L-Cysteine Hydrochloride L-Cysteine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20160614 UNAPPROVED DRUG OTHER Sandoz Inc CYSTEINE HYDROCHLORIDE 50 mg/mL N 20181231 0781-9037_a78873f7-ff02-4ade-93ca-cd8a353a2123 0781-9037 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20130228 ANDA ANDA200154 Sandoz Inc CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0781-9038_e6202e14-f9d3-49fc-a6a2-14535aea0457 0781-9038 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20130228 ANDA ANDA200159 Sandoz Inc CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0781-9039_a78873f7-ff02-4ade-93ca-cd8a353a2123 0781-9039 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20130228 ANDA ANDA200154 Sandoz Inc CISATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 0781-9105_c44a96cc-817d-4eb5-a13a-00977f76e666 0781-9105 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20111024 ANDA ANDA201588 Sandoz Inc OLANZAPINE 10 mg/2mL Atypical Antipsychotic [EPC] N 20181231 0781-9109_caf8e10f-c7c3-485e-b28d-5a7fe723f34e 0781-9109 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19760106 ANDA ANDA061490 Sandoz Inc OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9110_c501eeb6-476a-4cbe-b502-ab63e4845338 0781-9110 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19861223 ANDA ANDA062737 Sandoz Inc OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9111_caf8e10f-c7c3-485e-b28d-5a7fe723f34e 0781-9111 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19760106 ANDA ANDA061490 Sandoz Inc OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9112_c501eeb6-476a-4cbe-b502-ab63e4845338 0781-9112 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19861223 ANDA ANDA062737 Sandoz Inc OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9113_94d079a4-dd4d-40e8-aa05-fb8c53810612 0781-9113 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19910509 ANDA ANDA061490 Sandoz Inc OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9124_8da265ef-073e-4f2e-9019-ac9c45f12c7f 0781-9124 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz Inc NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9125_8da265ef-073e-4f2e-9019-ac9c45f12c7f 0781-9125 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz Inc NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9126_b7e26e43-3e4b-4579-a75e-50037aec8db4 0781-9126 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz Inc NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9158_a906dc84-d083-4da6-80eb-9e88d09c5bec 0781-9158 HUMAN PRESCRIPTION DRUG bivalirudin bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20151023 NDA AUTHORIZED GENERIC NDA020873 Sandoz BIVALIRUDIN 250 mg/1 Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 0781-9220_e02cbf83-afe3-48da-8bce-9e142c615c7f 0781-9220 HUMAN PRESCRIPTION DRUG Clindamycin in 5 Percent Dextrose Clindamycin in 5 Percent Dextrose INJECTION, SOLUTION INTRAVENOUS 20140301 ANDA ANDA201692 Sandoz Inc CLINDAMYCIN 6 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0781-9221_e02cbf83-afe3-48da-8bce-9e142c615c7f 0781-9221 HUMAN PRESCRIPTION DRUG Clindamycin in 5 Percent Dextrose Clindamycin in 5 Percent Dextrose INJECTION, SOLUTION INTRAVENOUS 20140301 ANDA ANDA201692 Sandoz Inc CLINDAMYCIN 12 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0781-9222_e02cbf83-afe3-48da-8bce-9e142c615c7f 0781-9222 HUMAN PRESCRIPTION DRUG Clindamycin in 5 Percent Dextrose Clindamycin in 5 Percent Dextrose INJECTION, SOLUTION INTRAVENOUS 20140301 ANDA ANDA201692 Sandoz Inc CLINDAMYCIN 18 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0781-9224_e7aaf035-63ce-4a16-87f3-e918f09052d1 0781-9224 HUMAN PRESCRIPTION DRUG Nafcillin Sodium Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19861223 ANDA ANDA062732 Sandoz Inc NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9225_e7aaf035-63ce-4a16-87f3-e918f09052d1 0781-9225 HUMAN PRESCRIPTION DRUG Nafcillin Sodium Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19861223 ANDA ANDA062732 Sandoz Inc NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9242_001568df-2242-4709-ac6e-4d36e2ed1745 0781-9242 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9250_001568df-2242-4709-ac6e-4d36e2ed1745 0781-9250 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9253_4f9486a9-211c-448e-afed-7cfc2eccb447 0781-9253 HUMAN PRESCRIPTION DRUG Azacitidine azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140327 NDA AUTHORIZED GENERIC NDA050794 Sandoz Inc AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0781-9261_001568df-2242-4709-ac6e-4d36e2ed1745 0781-9261 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9273_001568df-2242-4709-ac6e-4d36e2ed1745 0781-9273 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9302_9d5be1ff-0d4e-47a8-92f4-6a359e623045 0781-9302 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20120115 ANDA ANDA065461 Sandoz Inc TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0781-9303_9d5be1ff-0d4e-47a8-92f4-6a359e623045 0781-9303 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20120115 ANDA ANDA065461 Sandoz Inc TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0781-9304_9d5be1ff-0d4e-47a8-92f4-6a359e623045 0781-9304 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20120115 ANDA ANDA065461 Sandoz Inc TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0781-9314_6828ad9e-9584-40bf-8402-6e73e0b46d4c 0781-9314 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20110906 NDA NDA022434 Sandoz Inc ARGATROBAN 1 mg/mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 0781-9315_cddc261b-11bf-4d1d-bc98-2765722738ee 0781-9315 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20160701 ANDA ANDA078817 Sandoz Inc OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0781-9317_cddc261b-11bf-4d1d-bc98-2765722738ee 0781-9317 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20160701 ANDA ANDA078817 Sandoz Inc OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0781-9324_31105e1d-2504-424a-affb-78877470b247 0781-9324 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20100927 ANDA ANDA090125 Sandoz Inc. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 0781-9326_d9662c76-643a-4330-b7c9-9a6c46574dca 0781-9326 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-9327_d9662c76-643a-4330-b7c9-9a6c46574dca 0781-9327 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-9328_d9662c76-643a-4330-b7c9-9a6c46574dca 0781-9328 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-9329_d9662c76-643a-4330-b7c9-9a6c46574dca 0781-9329 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Sandoz Inc CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-9338_4a9f2a75-b3ae-4d98-aedc-1fca6be8e59a 0781-9338 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 19881209 ANDA ANDA062831 Sandoz Inc CEFAZOLIN SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 0781-9344_1abccd91-74a5-4883-b4c2-1d932a72eb30 0781-9344 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160316 ANDA ANDA065523 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-9350_1abccd91-74a5-4883-b4c2-1d932a72eb30 0781-9350 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160316 ANDA ANDA065523 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-9367_1abccd91-74a5-4883-b4c2-1d932a72eb30 0781-9367 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160316 ANDA ANDA065523 Sandoz Inc PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 0781-9401_300efbc5-d29b-4b57-892c-72898d22cd8d 0781-9401 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 125 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9402_300efbc5-d29b-4b57-892c-72898d22cd8d 0781-9402 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9404_300efbc5-d29b-4b57-892c-72898d22cd8d 0781-9404 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9407_300efbc5-d29b-4b57-892c-72898d22cd8d 0781-9407 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9408_300efbc5-d29b-4b57-892c-72898d22cd8d 0781-9408 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9409_11d2bbec-f3f9-41e0-9ec9-073e69b47f70 0781-9409 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz Inc AMPICILLIN SODIUM 10 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9412_beaedac9-8a9f-40b1-8063-9ac3a9946ba0 0781-9412 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870219 ANDA ANDA062738 Sandoz Inc AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0781-9413_beaedac9-8a9f-40b1-8063-9ac3a9946ba0 0781-9413 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870219 ANDA ANDA062738 Sandoz Inc AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 0799-0001_e21864d6-b96d-45f1-8a07-7b6ebb8d5c2b 0799-0001 HUMAN OTC DRUG Calmoseptine Anorectal Ointment OINTMENT TOPICAL 19500801 OTC MONOGRAPH FINAL part346 Calmoseptine Inc. LANOLIN; MENTHOL; PETROLATUM; ZINC OXIDE 15.7; .44; 24; 20.6 g/100g; g/100g; g/100g; g/100g N 20181231 0802-2685_5da31cab-52b0-f458-e053-2991aa0a0ed1 0802-2685 HUMAN OTC DRUG Medis Sodium Bicarbonate Sodium Bicarbonate POWDER ORAL 20171109 20200430 OTC MONOGRAPH FINAL part331 Humco Holding Group, Inc SODIUM BICARBONATE 1000 mg/g N 20181231 0813-0202_9e230010-696b-42ff-af18-768dce0b5c87 0813-0202 HUMAN PRESCRIPTION DRUG O-Cal Prenatal Vitamin Vitamin A, Ascorbic Acid, Cholecalciferol, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, Riboflavin, Niacin, Pyridoxine, Folic Acid, Cyanocobalamin, Calcium, FERROUS FUMARATE, Iodine, Magnesium, Zinc, and Copper TABLET ORAL 20020123 UNAPPROVED DRUG OTHER Pharmics, Inc. VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM; FERROUS FUMARATE; IODINE; MAGNESIUM; ZINC; COPPER 2500; 70; 400; 30; 1.5; 1.6; 17; 12; 1; 12; 200; 15; 150; 100; 15; 2 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 0813-0799_226ac5f4-e05a-4b52-9f66-aa2a2a7009f3 0813-0799 HUMAN PRESCRIPTION DRUG Fem pH Acetic Acid and Oxyquinoline sulfate JELLY VAGINAL 19990715 UNAPPROVED DRUG OTHER Pharmics, Inc. ACETIC ACID; OXYQUINOLINE SULFATE .009; .00025 g/g; g/g E 20171231 0813-9616_507a2816-6da4-4b00-af8f-8be0178cb698 0813-9616 HUMAN PRESCRIPTION DRUG O-Cal FA multivitamin VITAMIN A ACETATE, Ascorbic Acid, Cholecalciferol, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, Riboflavin, Niacin, Pyridoxine, Folic Acid, Cyanocobalamin, CALCIUM CARBONATE, FERROUS FUMARATE, Iodine, Magnesium, Zinc, Copper, and Sodium Fluoride TABLET ORAL 19700115 UNAPPROVED DRUG OTHER Pharmics, Inc. VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; IODINE; MAGNESIUM; ZINC; COPPER; SODIUM FLUORIDE 2500; 90; 400; 30; 3; 3; 20; 4; 1; 12; 200; 27; 150; 100; 15; 2; .5 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 0832-0038_9bf3813d-c56e-4ea9-9c7f-2368206098df 0832-0038 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20111107 ANDA ANDA074625 Upsher-Smith Laboratories, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 0832-0042_6271d2d0-8bf2-475d-8591-ca65740993ce 0832-0042 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070709 ANDA ANDA077759 Upsher-Smith Laboratories, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0832-0043_6271d2d0-8bf2-475d-8591-ca65740993ce 0832-0043 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070709 ANDA ANDA077759 Upsher-Smith Laboratories, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0832-0044_6271d2d0-8bf2-475d-8591-ca65740993ce 0832-0044 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070709 ANDA ANDA077759 Upsher-Smith Laboratories, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0832-0086_c3b32092-fa7d-421c-85ea-03e2b79269a9 0832-0086 HUMAN PRESCRIPTION DRUG Androxy fluoxymesterone TABLET ORAL 19831021 ANDA ANDA088342 Upsher-Smith Laboratories, LLC FLUOXYMESTERONE 10 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0832-0111_fba2628a-bd79-4546-88b1-80a9f5e98d97 0832-0111 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride amantadine hydrochloride TABLET ORAL 20111215 ANDA ANDA076186 Upsher-Smith Laboratories, LLC AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 0832-0225_1fbd044d-4a32-4a1d-a9c6-f2da92d27c8c 0832-0225 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, LLC MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0832-0226_1fbd044d-4a32-4a1d-a9c6-f2da92d27c8c 0832-0226 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, LLC MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0832-0227_1fbd044d-4a32-4a1d-a9c6-f2da92d27c8c 0832-0227 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0832-0228_1fbd044d-4a32-4a1d-a9c6-f2da92d27c8c 0832-0228 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, LLC MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0832-0229_1fbd044d-4a32-4a1d-a9c6-f2da92d27c8c 0832-0229 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0832-0230_1fbd044d-4a32-4a1d-a9c6-f2da92d27c8c 0832-0230 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, LLC MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0832-0233_1fbd044d-4a32-4a1d-a9c6-f2da92d27c8c 0832-0233 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Upsher-Smith Laboratories, LLC MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0832-0290_d5581ffe-d48a-46f5-8303-691f5195d4a2 0832-0290 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine Hydrochloride SPRAY NASAL 20170317 ANDA ANDA202609 Upsher-Smith Laboratories, Inc. AZELASTINE HYDROCHLORIDE 137 ug/.137mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0832-0300_2c5dc351-a381-4b22-93ec-4bc93b4bb3a6 0832-0300 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110808 ANDA ANDA083386 Upsher-Smith Laboratories, Inc. CHLORPROMAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0832-0301_2c5dc351-a381-4b22-93ec-4bc93b4bb3a6 0832-0301 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084112 Upsher-Smith Laboratories, Inc. CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0832-0302_2c5dc351-a381-4b22-93ec-4bc93b4bb3a6 0832-0302 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084113 Upsher-Smith Laboratories, Inc. CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0832-0303_2c5dc351-a381-4b22-93ec-4bc93b4bb3a6 0832-0303 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084114 Upsher-Smith Laboratories, Inc. CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0832-0304_2c5dc351-a381-4b22-93ec-4bc93b4bb3a6 0832-0304 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084115 Upsher-Smith Laboratories, Inc. CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0832-0310_32b9e520-f184-4d6b-a5a5-3a8833a0c2c6 0832-0310 HUMAN PRESCRIPTION DRUG valproic acid valproic acid CAPSULE ORAL 20111029 ANDA ANDA073229 Upsher-Smith Laboratories, LLC VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 0832-0465_3d37d5e6-797e-4852-87be-6d06732c5f75 0832-0465 HUMAN PRESCRIPTION DRUG Nyamyc Nystatin POWDER TOPICAL 20050503 ANDA ANDA065183 Upsher-Smith Laboratories Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 0832-0480_12f0b9e4-6c64-4749-b441-e2750647cdac 0832-0480 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20150316 ANDA ANDA078510 Upsher-Smith Laboratories, Inc. EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0832-0481_12f0b9e4-6c64-4749-b441-e2750647cdac 0832-0481 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20150316 ANDA ANDA078510 Upsher-Smith Laboratories, Inc. EPLERENONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0832-0483_7794a7af-1e84-43f3-986f-ccc523ef654c 0832-0483 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150316 ANDA ANDA076631 Upsher-Smith Laboratories, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0832-0484_7794a7af-1e84-43f3-986f-ccc523ef654c 0832-0484 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150316 ANDA ANDA076631 Upsher-Smith Laboratories, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0832-0485_7794a7af-1e84-43f3-986f-ccc523ef654c 0832-0485 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150316 ANDA ANDA076631 Upsher-Smith Laboratories, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 0832-0494_09dc7f6a-cc69-4de8-8e13-b837ce144b4a 0832-0494 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET, FILM COATED ORAL 20150309 ANDA ANDA085785 Upsher-Smith Laboratories, Inc. TRIFLUOPERAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 0832-0495_09dc7f6a-cc69-4de8-8e13-b837ce144b4a 0832-0495 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET, FILM COATED ORAL 20150309 ANDA ANDA085786 Upsher-Smith Laboratories, Inc. TRIFLUOPERAZINE HYDROCHLORIDE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 0832-0496_09dc7f6a-cc69-4de8-8e13-b837ce144b4a 0832-0496 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET, FILM COATED ORAL 20150309 ANDA ANDA085789 Upsher-Smith Laboratories, Inc. TRIFLUOPERAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 0832-0497_09dc7f6a-cc69-4de8-8e13-b837ce144b4a 0832-0497 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride Trifluoperazine Hydrochloride TABLET, FILM COATED ORAL 20150309 ANDA ANDA085788 Upsher-Smith Laboratories, Inc. TRIFLUOPERAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 0832-0510_8813ae33-f2f0-4ffe-aa56-6bdb91247d73 0832-0510 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100124 ANDA ANDA040633 Upsher-Smith Laboratories, LLC BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0832-0511_8813ae33-f2f0-4ffe-aa56-6bdb91247d73 0832-0511 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100124 ANDA ANDA040634 Upsher-Smith Laboratories, LLC BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0832-0512_8813ae33-f2f0-4ffe-aa56-6bdb91247d73 0832-0512 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100124 ANDA ANDA040635 Upsher-Smith Laboratories, LLC BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0832-0513_8813ae33-f2f0-4ffe-aa56-6bdb91247d73 0832-0513 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100124 ANDA ANDA040636 Upsher-Smith Laboratories, LLC BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0832-0540_72c149e1-eaa1-4c71-975f-0c7706f3bbe3 0832-0540 HUMAN PRESCRIPTION DRUG Bumetanide BUMETANIDE TABLET ORAL 20180130 ANDA ANDA209916 Upsher-Smith Laboratories, LLC BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 0832-0541_72c149e1-eaa1-4c71-975f-0c7706f3bbe3 0832-0541 HUMAN PRESCRIPTION DRUG Bumetanide BUMETANIDE TABLET ORAL 20180130 ANDA ANDA209916 Upsher-Smith Laboratories, LLC BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 0832-0542_72c149e1-eaa1-4c71-975f-0c7706f3bbe3 0832-0542 HUMAN PRESCRIPTION DRUG Bumetanide BUMETANIDE TABLET ORAL 20180130 ANDA ANDA209916 Upsher-Smith Laboratories, LLC BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 0832-0595_8a5f2b0b-943d-4012-8c72-2fae01e18b60 0832-0595 HUMAN PRESCRIPTION DRUG Exemestane Exemestane TABLET ORAL 20170727 ANDA ANDA209208 Upsher-Smith Laboratories, Inc. EXEMESTANE 25 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 0832-0630_05efab58-ba3c-4e54-bf18-1e66e1b0e41a 0832-0630 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 20170321 ANDA ANDA074953 Upsher-Smith Laboratories, Inc. CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0832-0631_05efab58-ba3c-4e54-bf18-1e66e1b0e41a 0832-0631 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 20170321 ANDA ANDA074953 Upsher-Smith Laboratories, Inc. CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0832-0632_05efab58-ba3c-4e54-bf18-1e66e1b0e41a 0832-0632 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 20170321 ANDA ANDA074953 Upsher-Smith Laboratories, Inc. CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0832-1015_18d6b1e6-c6b6-4c03-aae9-b7d8bd0279c7 0832-1015 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride amantadine hydrochloride CAPSULE, GELATIN COATED ORAL 20110915 ANDA ANDA070589 Upsher-Smith Laboratories, Inc AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 0832-1024_b84f3ae8-1c33-4cdd-85eb-a5ef0370b312 0832-1024 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20101020 ANDA ANDA074584 Upsher-Smith Laboratories, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20191231 0832-1025_b84f3ae8-1c33-4cdd-85eb-a5ef0370b312 0832-1025 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20101020 ANDA ANDA074584 Upsher-Smith Laboratories, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20191231 0832-1071_4a7609df-3738-4577-8a66-c6ed37128811 0832-1071 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140707 NDA AUTHORIZED GENERIC NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0832-1072_4a7609df-3738-4577-8a66-c6ed37128811 0832-1072 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140707 NDA AUTHORIZED GENERIC NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0832-1073_4a7609df-3738-4577-8a66-c6ed37128811 0832-1073 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140707 NDA AUTHORIZED GENERIC NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0832-1074_4a7609df-3738-4577-8a66-c6ed37128811 0832-1074 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140707 NDA AUTHORIZED GENERIC NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0832-1075_4a7609df-3738-4577-8a66-c6ed37128811 0832-1075 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, EXTENDED RELEASE ORAL 20140707 NDA AUTHORIZED GENERIC NDA205122 Upsher-Smith Laboratories, Inc. TOPIRAMATE 150 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0832-1080_52fc088c-f019-4227-8e96-6c73f3025fac 0832-1080 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 19961212 ANDA ANDA040103 Upsher-Smith Laboratories, Inc. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20191231 0832-1081_52fc088c-f019-4227-8e96-6c73f3025fac 0832-1081 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 19961212 ANDA ANDA040103 Upsher-Smith Laboratories, Inc. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20191231 0832-1082_52fc088c-f019-4227-8e96-6c73f3025fac 0832-1082 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 19961212 ANDA ANDA040103 Upsher-Smith Laboratories, Inc. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20191231 0832-1112_38c9c982-916f-4fce-bd93-be2ef3f9728a 0832-1112 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20150731 ANDA ANDA090043 Upsher-Smith Laboratories, Inc MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 0832-1113_38c9c982-916f-4fce-bd93-be2ef3f9728a 0832-1113 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20150731 ANDA ANDA090043 Upsher-Smith Laboratories, Inc MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 0832-1120_f5dd0c68-9c39-440d-959c-02ba2a5aa37b 0832-1120 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL TOPICAL 20140616 NDA AUTHORIZED GENERIC NDA204399 Upsher-Smith Laboratories, Inc. TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0832-1121_f5dd0c68-9c39-440d-959c-02ba2a5aa37b 0832-1121 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL, METERED TOPICAL 20140616 NDA AUTHORIZED GENERIC NDA204399 Upsher-Smith Laboratories, Inc. TESTOSTERONE 12.5 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 0832-1211_c53792d1-2f38-4285-bca6-f9c40565e4cb 0832-1211 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0832-1212_c53792d1-2f38-4285-bca6-f9c40565e4cb 0832-1212 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0832-1213_c53792d1-2f38-4285-bca6-f9c40565e4cb 0832-1213 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0832-1214_c53792d1-2f38-4285-bca6-f9c40565e4cb 0832-1214 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, LLC WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0832-1215_c53792d1-2f38-4285-bca6-f9c40565e4cb 0832-1215 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, LLC WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0832-1216_c53792d1-2f38-4285-bca6-f9c40565e4cb 0832-1216 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0832-1217_c53792d1-2f38-4285-bca6-f9c40565e4cb 0832-1217 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, LLC WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0832-1218_c53792d1-2f38-4285-bca6-f9c40565e4cb 0832-1218 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, LLC WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0832-1219_c53792d1-2f38-4285-bca6-f9c40565e4cb 0832-1219 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Upsher-Smith Laboratories, LLC WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 0832-2012_dc5841ec-abee-4031-96bb-b9693ab0b211 0832-2012 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 Upsher-Smith Laboratories, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 0832-7122_4ec0bef5-4044-4595-a145-881187ab665b 0832-7122 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20140321 ANDA ANDA078182 Upsher-Smith Laboratories, Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0832-7123_4ec0bef5-4044-4595-a145-881187ab665b 0832-7123 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20140321 ANDA ANDA078182 Upsher-Smith Laboratories, Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0832-7124_4ec0bef5-4044-4595-a145-881187ab665b 0832-7124 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20140321 ANDA ANDA078182 Upsher-Smith Laboratories, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0869-0004_724d9a87-09d3-4025-b0a5-82635039cf16 0869-0004 HUMAN OTC DRUG Kids Anticavity Kids Anticavity MOUTHWASH ORAL 20040406 OTC MONOGRAPH FINAL part355 Vi Jon SODIUM FLUORIDE .02 kg/100L N 20181231 0869-0005_27a6670d-f623-43a9-a20e-197cce8386f5 0869-0005 HUMAN OTC DRUG Sunburn Relief Gel Lidocaine HCl GEL TOPICAL 20170110 OTC MONOGRAPH NOT FINAL part348 Vi-Jon, Inc LIDOCAINE HYDROCHLORIDE 5.05 g/g N 20181231 0869-0013_23544951-3006-47aa-9a97-6393f6800820 0869-0013 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20150206 OTC MONOGRAPH FINAL part347 Sound Body LANOLIN; PETROLATUM 133; 459 mg/g; mg/g N 20181231 0869-0041_a08a6992-92b7-4fb9-b344-d4b2285634d4 0869-0041 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20080917 OTC MONOGRAPH FINAL part333D Vi-Jon SALICYLIC ACID 19.8 mg/g N 20181231 0869-0041_f8c47776-597e-456f-95c5-fb3371e7f758 0869-0041 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20150113 OTC MONOGRAPH FINAL part333D Vi-Jon SALICYLIC ACID 19.8 mg/g N 20181231 0869-0050_0757fa7d-2b25-4715-985b-45277522d439 0869-0050 HUMAN OTC DRUG Povidone Iodine Solution First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20090507 OTC MONOGRAPH NOT FINAL part333E Vi Jon POVIDONE-IODINE 10.34 mg/mL N 20191231 0869-0063_5c11c9fa-2950-4625-b48f-f0cfd1b3e63e 0869-0063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Vi Jon FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 0869-0072_f15b1a0f-9d52-4cda-8ca9-04699032d7d3 0869-0072 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Methyl salicylate, thymol MOUTHWASH ORAL 19880720 OTC MONOGRAPH NOT FINAL part356 Vi Jon, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 0869-0078_616665ac-8cb8-44ec-8a6e-ecc8e309a7fe 0869-0078 HUMAN OTC DRUG Castor Oil Castor Oil LIQUID ORAL 19890715 OTC MONOGRAPH NOT FINAL part334 Vi-Jon CASTOR OIL 1 g/mL N 20181231 0869-0088_3684e840-1421-4899-b649-18244941d6e5 0869-0088 HUMAN OTC DRUG Iodine Iodine LIQUID TOPICAL 20170807 OTC MONOGRAPH NOT FINAL part333A Vi-Jon IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 0869-0104_5a1a12d7-5375-427e-938b-fed7d610e192 0869-0104 HUMAN OTC DRUG Oil-Free Astringent Salicylic acid LIQUID TOPICAL 20160803 OTC MONOGRAPH FINAL part333D Vi-Jon SALICYLIC ACID 18 mg/mL N 20191231 0869-0153_ba24fb7f-fbf1-437b-9032-1b09a0c79dfd 0869-0153 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090113 OTC MONOGRAPH FINAL part358H Vi-Jon PYRITHIONE ZINC 10 mg/mL N 20191231 0869-0163_f72d827f-1561-490d-95ac-a672850feeaf 0869-0163 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20060513 OTC MONOGRAPH FINAL part355 Swan SODIUM FLUORIDE 999.5 mL/100L N 20181231 0869-0211_d3100ee0-233c-44ec-abee-4ab31bd00aa5 0869-0211 HUMAN OTC DRUG Isopropyl ISOPROPYL ALCOHOL LIQUID TOPICAL 20040930 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ISOPROPYL ALCOHOL 924 mg/mL N 20181231 0869-0213_79249f1b-3aad-434a-b306-a6c7f896e35f 0869-0213 HUMAN OTC DRUG Anticavity Sodium Fluoride RINSE ORAL 20010621 OTC MONOGRAPH FINAL part355 Vi Jon SODIUM FLUORIDE .05 kg/100L N 20181231 0869-0218_3a9be7a6-6c2a-495d-a10a-661ba7ea203d 0869-0218 HUMAN OTC DRUG Clear Anti Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 19940507 OTC MONOGRAPH FINAL part347 /Vi-Jon PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 0869-0219_d981c865-b6e2-496b-8173-003b29fd933e 0869-0219 HUMAN OTC DRUG Blackhead Clearing Scrub Salicylic acid GEL TOPICAL 20070813 OTC MONOGRAPH FINAL part333D Vi-Jon SALICYLIC ACID 19.4 mg/g N 20181231 0869-0226_b1e820cd-f4e9-4efe-8108-3fb15d318bba 0869-0226 HUMAN OTC DRUG Diaper Rash Zinc oxide CREAM TOPICAL 20150707 OTC MONOGRAPH NOT FINAL part348 Vi-Jon ZINC OXIDE 130 mg/g N 20181231 0869-0247_c8e5e518-d8c7-4db1-a717-760f4ca4bb5e 0869-0247 HUMAN OTC DRUG Advanced Healing Petrolatum OINTMENT TOPICAL 20170320 OTC MONOGRAPH FINAL part347 Vi-Jon PETROLATUM 340 mg/100g N 20191231 0869-0295_ee39cf11-4d8e-4b92-9454-113129e72312 0869-0295 HUMAN OTC DRUG Itch Relief Diphenhydramine HCl, Zinc Acetate SPRAY TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part348 Vi-Jon DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 18; 882 mg/mL; mg/mL N 20181231 0869-0299_7da4afe3-bfcc-48aa-b2d2-763f9e3d7332 0869-0299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 19950105 OTC MONOGRAPH NOT FINAL part356 Vi-Jon CETYLPYRIDINIUM CHLORIDE .07 kg/100L N 20181231 0869-0318_12793dd5-ef29-4633-ae5f-fb6216af66aa 0869-0318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 19890715 OTC MONOGRAPH NOT FINAL part356 Vi-Jon EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 0869-0338_8541c615-3285-46b0-95de-01ccb5b4b9ee 0869-0338 HUMAN OTC DRUG daily moisturizer Avobenzone, Octinoxate, Octisalate LOTION TOPICAL 20170806 OTC MONOGRAPH FINAL part352 Vi-Jon AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL N 20191231 0869-0353_2a1b86da-bf2a-4b6f-a177-67c75050ce0e 0869-0353 HUMAN OTC DRUG Body Wash Salicylic Acid GEL TOPICAL 20150115 OTC MONOGRAPH FINAL part333D Vi-Jon, Inc SALICYLIC ACID 25 mg/mL N 20181231 0869-0354_dc653ded-0920-454f-b9a4-b0a099c8bcea 0869-0354 HUMAN OTC DRUG Daily Baby Dimethicone LOTION TOPICAL 20170915 OTC MONOGRAPH FINAL part347 Vi-Jon, Inc DIMETHICONE 13.1 mg/g N 20181231 0869-0370_04725abb-8671-49ed-8fc7-438c65eab8aa 0869-0370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20140804 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 70 mL/100mL N 20181231 0869-0434_dd59e732-afc3-41f9-bbd6-516614ac7473 0869-0434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130610 OTC MONOGRAPH NOT FINAL part356 Vi-Jon EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0869-0435_a032ce20-8ed9-43e3-bbad-cb0e9d2f3f42 0869-0435 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20150909 OTC MONOGRAPH FINAL part355 Vi-Jon, Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 0869-0462_5d138053-6a84-4830-a30b-128f897e06fb 0869-0462 HUMAN OTC DRUG Sore Mouth Cleanser Hydrogen Peroxide MOUTHWASH TOPICAL 20170502 OTC MONOGRAPH NOT FINAL part333A Vi-Jon HYDROGEN PEROXIDE 1588 mg/mL N 20181231 0869-0482_f72fcec6-1e16-486f-8ab8-158f8ceb4adf 0869-0482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20130201 OTC MONOGRAPH FINAL part355 Vi-Jon SODIUM FLUORIDE 219 mg/mL N 20181231 0869-0492_62a8623b-6501-4af9-94d1-9fb3f0b724a6 0869-0492 HUMAN OTC DRUG Foaming Hand Sanitizer Benzalkonium chloride LIQUID TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333A Vi-Jon BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 0869-0494_56e97cc4-8cc3-4739-83c8-e7c7877c2d4f 0869-0494 HUMAN OTC DRUG Cooling Epsom Rub Menthol GRANULE, FOR SOLUTION TOPICAL 20170324 OTC MONOGRAPH NOT FINAL part348 Vi-Jon, Inc MENTHOL 11.7 mg/mL N 20181231 0869-0496_eabbd078-8bb0-46cd-b69b-1925410dbff2 0869-0496 HUMAN OTC DRUG Daily Baby Dimethicone LOTION TOPICAL 20160428 OTC MONOGRAPH FINAL part347 Vi-Jon DIMETHICONE 12.12 mg/mL N 20181231 0869-0551_20f4595b-1c25-4945-9953-6b5c3381557f 0869-0551 HUMAN OTC DRUG Medicated menthol, zinc oxide POWDER TOPICAL 20030812 OTC MONOGRAPH NOT FINAL part348 Vi-Jon MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g N 20181231 0869-0576_bcf70fc0-4708-49fe-ada6-d18ecd1dbf30 0869-0576 HUMAN OTC DRUG Alcohol Free Refreshing Mint Sodium fluoride MOUTHWASH ORAL 20170315 OTC MONOGRAPH FINAL part355 Vi-Jon SODIUM FLUORIDE 10.41 mg/mL N 20181231 0869-0602_9cde77d1-ac7a-4d92-a0e4-9b01d8ba8cae 0869-0602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 19980715 OTC MONOGRAPH NOT FINAL part334 Vi-Jon MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 0869-0615_f535d975-3063-46f6-9374-8bff500aa617 0869-0615 HUMAN OTC DRUG Daily Moisturizer Salicylic acid CREAM TOPICAL 20170602 OTC MONOGRAPH FINAL part333D Vi-Jon, Inc SALICYLIC ACID 5.05 mg/mL N 20191231 0869-0619_0cfe2aef-befd-454f-b53b-1d68c1f7b596 0869-0619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20150601 OTC MONOGRAPH FINAL part347 Vi-Jon DIMETHICONE 13 mg/mL N 20191231 0869-0664_d51db73c-5048-4b7b-a95b-07e12be2e00f 0869-0664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19920715 OTC MONOGRAPH NOT FINAL part356 Vi-Jon EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0869-0667_cdaa364a-7289-43a1-89ff-270ea60662e7 0869-0667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 19890715 OTC MONOGRAPH FINAL part334 Vi Jon, Inc MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 0869-0672_68ec5246-e3ad-4342-98db-2b019970c6be 0869-0672 HUMAN OTC DRUG Warming Epsom Rub Menthol GRANULE, FOR SOLUTION TOPICAL 20170330 OTC MONOGRAPH NOT FINAL part348 Vi-Jon, Inc MENTHOL 11.7 mg/mL N 20181231 0869-0686_bb9c06db-2244-408b-a8eb-528350e7702c 0869-0686 HUMAN OTC DRUG Citroma Magnesium Citrate Citroma Magnesium Citrate LIQUID ORAL 19790619 OTC MONOGRAPH NOT FINAL part334 Vi-Jon MAGNESIUM CITRATE 1.745 g/29.6mL N 20191231 0869-0693_fe1e98a1-2ffe-40fd-abaf-2b1546393850 0869-0693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19890715 OTC MONOGRAPH NOT FINAL part334 Vi-Jon MAGNESIUM CITRATE 1.745 g/29.6mL N 20191231 0869-0706_8996cd86-72a1-4e57-ba1c-3e9a85bbd130 0869-0706 HUMAN OTC DRUG Active Sport Avobenzone, Homosalate, Octisalate. Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Vi-Jon, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.3; 101; 50.5; 101 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0869-0711_876624e4-da25-424c-a7d8-8d9601f5293d 0869-0711 HUMAN OTC DRUG Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160112 OTC MONOGRAPH FINAL part352 Vi-Jon, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 72.1; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; 1/mL N 20181231 0869-0714_b9ec2533-d7bc-4ebc-8313-d730e16ed67b 0869-0714 HUMAN OTC DRUG Avobenzone, Homosalate, Octisalate, Octocrylene Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20161128 OTC MONOGRAPH FINAL part352 Vi-Jon, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.3; 101; 50.5; 101 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 0869-0722_62b52c05-975e-48cd-ac59-f51f625bbc79 0869-0722 HUMAN OTC DRUG Sheer Touch Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20170920 OTC MONOGRAPH NOT FINAL part352 Vi-Jon AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0869-0727_2d226e01-1b25-477d-9bd9-4a30c83dcdf8 0869-0727 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Vi-Jon AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 26.49; 132.45; 44.15; 52.98 mg/g; mg/g; mg/g; mg/g N 20181231 0869-0729_19d6d2fa-6624-4836-9966-0557f6ca7703 0869-0729 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Vi-Jon AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 26.49; 132.45; 43.45; 52.98 mg/g; mg/g; mg/g; mg/g N 20181231 0869-0730_8c75e210-6825-4810-a643-06c3d66ca734 0869-0730 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Vi-Jon AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 20; 150; 50; 40 mg/g; mg/g; mg/g; mg/g N 20181231 0869-0752_5c487c2e-db85-4c56-9835-154e4318f6ed 0869-0752 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Vi-Jon AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 72.1; 41.2 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 0869-0760_229e960b-b606-4605-95b8-8ad9cd88117d 0869-0760 HUMAN OTC DRUG Sheer Touch Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20170920 OTC MONOGRAPH NOT FINAL part352 Vi-Jon AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0869-0787_4038f395-d2db-4d88-bc30-2caa7b6f9d84 0869-0787 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Vi-Jon AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 26.49; 132.45; 44.15; 52.98 mg/g; mg/g; mg/g; mg/g N 20181231 0869-0788_5f9936a1-3693-43c0-bed8-ed48efbd3911 0869-0788 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Vi-Jon AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27.03; 135.15; 45.05; 90.1; 54.06 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 0869-0789_ddf6c8da-6f5c-41fe-a70e-4be028e11369 0869-0789 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Vi-Jon AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.07; 86.9; 43.45; 34.76; 43.45 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 0869-0790_6c67d65d-6aeb-4760-a66e-8deb394f349b 0869-0790 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Vi-Jon AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.95; 86.5; 43.25; 17.3; 34.6 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 0869-0792_39c4ca21-474c-4535-bbad-fc6307b2c1b1 0869-0792 HUMAN OTC DRUG Sheer Touch Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20170920 OTC MONOGRAPH NOT FINAL part352 Vi-Jon AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0869-0793_b6728348-e080-4863-81dd-b8500bcd97e2 0869-0793 HUMAN OTC DRUG Active Sport Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Vi-Jon, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.6; 30.6; 45.9; 45.9; 55.08 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 0869-0804_7e31360d-c184-46a3-8a69-4261101de4ba 0869-0804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ISOPROPYL ALCOHOL 91 kg/100L N 20181231 0869-0810_b8afd6d2-0959-43ee-80fc-b4bf9e3af677 0869-0810 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ISOPROPYL ALCOHOL 700 mg/mL N 20191231 0869-0816_995e218d-f4ab-427b-b027-32411d0df50c 0869-0816 HUMAN OTC DRUG Dandruff Selenium sulfide SHAMPOO TOPICAL 20160925 OTC MONOGRAPH FINAL part358H Vi-Jon SELENIUM SULFIDE 10 mg/mL N 20181231 0869-0821_b8a620d3-bd67-4692-9dfb-2ac0c462302e 0869-0821 HUMAN OTC DRUG Acne Scrub Salicylic Acid GEL TOPICAL 20171214 OTC MONOGRAPH FINAL part333D Vi-Jon, Inc SALICYLIC ACID 21 mg/mL N 20191231 0869-0822_840b931a-500c-4ed9-93d0-9ed3c2f80f46 0869-0822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19980129 OTC MONOGRAPH FINAL part347 Vi-Jon WITCH HAZEL 86 kg/100L N 20191231 0869-0831_200bd330-5899-40e4-8644-4adc97ef033f 0869-0831 HUMAN OTC DRUG oil Mineral Oil OIL ORAL 19890715 OTC MONOGRAPH NOT FINAL part334 Vi-Jon MINERAL OIL 1 mg/mL N 20181231 0869-0845_2b7efaa3-e72c-485e-825a-ad01a433dca8 0869-0845 HUMAN OTC DRUG 70% Rubbing Isopropyl Alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ISOPROPYL ALCOHOL 500 mg/mL N 20191231 0869-0850_3524c491-6efc-4f3d-9561-111288dab729 0869-0850 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20171201 OTC MONOGRAPH FINAL part358H Vi-Jon, Inc. COAL TAR 1.02 mg/mL N 20181231 0869-0861_9e4e5fb5-a42b-41ca-9bd0-16d3fc65775c 0869-0861 HUMAN OTC DRUG Oil Free Moisturizer Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20160225 OTC MONOGRAPH FINAL part352 Vi-Jon OCTINOXATE; OCTISALATE; AVOBENZONE 76.5; 51; 30.6 mg/mL; mg/mL; mg/mL N 20191231 0869-0864_2c2d6130-d9c1-499c-83d0-9061162a5337 0869-0864 HUMAN OTC DRUG 50% Rubbing Isopropyl Alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ISOPROPYL ALCOHOL 500 mg/mL N 20181231 0869-0864_d7237de8-ae66-433d-91ec-2790cc6ac6e8 0869-0864 HUMAN OTC DRUG 50% Rubbing Isopropyl Alcohol LIQUID TOPICAL 20170320 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ISOPROPYL ALCOHOL 500 mg/mL N 20181231 0869-0871_4cf8be55-3d11-41c0-a8a3-0fb0779b6622 0869-0871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20170709 OTC MONOGRAPH NOT FINAL part333A Vi-Jon HYDROGEN PEROXIDE 30 mg/mL N 20181231 0869-0875_edc3e89f-22ce-4ff8-b283-2b2154d3b5b4 0869-0875 HUMAN OTC DRUG Salicylic Acid Astringent LIQUID TOPICAL 20170318 OTC MONOGRAPH FINAL part333D Vi-Jon SALICYLIC ACID 5 mg/mL N 20181231 0869-0876_aac6892b-834e-4d10-b51f-40536209fdff 0869-0876 HUMAN OTC DRUG Rubbing Ethyl Alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 610 mg/mL N 20191231 0869-0893_973a46bd-2640-4b6b-8627-6fb47048ddb9 0869-0893 HUMAN OTC DRUG Anticavity Fluoride Rinse Anticavity Fluoride MOUTHWASH ORAL 20090916 OTC MONOGRAPH FINAL part355 Vi Jon SODIUM FLUORIDE .0221 kg/100L N 20181231 0869-0910_4165e028-4635-417a-b952-ce7406b4278c 0869-0910 HUMAN OTC DRUG Salicylic Acid Salicylic Acid CREAM TOPICAL 20160301 OTC MONOGRAPH FINAL part333D Vi-Jon SALICYLIC ACID 20.6 mg/mL N 20181231 0869-0947_d764fdaa-8b3f-4f15-8ef3-8a7919ce628f 0869-0947 HUMAN OTC DRUG Oil Free Acne Wash Salicylic acid 2% LOTION TOPICAL 20170320 OTC MONOGRAPH FINAL part333D Vi-Jon SALICYLIC ACID 20.6 mg/mL N 20181231 0869-0965_a5dfa511-749a-47ad-8995-c6df390b7d73 0869-0965 HUMAN OTC DRUG Colloidal oatmeal Colloidal oatmeal CREAM TOPICAL 20140422 OTC MONOGRAPH FINAL part347 Vi-Jon OATMEAL 10.4 mg/g N 20191231 0869-0995_a21973f0-e896-49bd-b25a-a0eaaa62ef4a 0869-0995 HUMAN OTC DRUG Octinoxate, Octisalate, Avobenzone Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20160225 OTC MONOGRAPH FINAL part352 Vi-Jon OCTINOXATE; OCTISALATE; AVOBENZONE 76.5; 51; 30.6 mg/mL; mg/mL; mg/mL N 20191231 0884-0293_cae66912-e0bf-4861-b4a5-3a6e02b53cd6 0884-0293 HUMAN OTC DRUG fungoid tincture miconazole nitrate TINCTURE TOPICAL 19940101 OTC MONOGRAPH FINAL part333C Pedinol Pharmacal, Inc. MICONAZOLE NITRATE 20 mg/mL N 20181231 0884-0763_d3d67926-0727-496e-b54c-d6c8770f84d6 0884-0763 HUMAN PRESCRIPTION DRUG Gris-PEG griseofulvin TABLET, FILM COATED ORAL 20160726 NDA NDA050475 Pedinol Pharmacal, Inc. GRISEOFULVIN 125 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 0884-0773_d3d67926-0727-496e-b54c-d6c8770f84d6 0884-0773 HUMAN PRESCRIPTION DRUG Gris-PEG griseofulvin TABLET, FILM COATED ORAL 20160726 NDA NDA050475 Pedinol Pharmacal, Inc. GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 0884-1706_a59ce8b4-9cf3-46a2-b60d-27468a44b565 0884-1706 HUMAN OTC DRUG Pedi-Boro Soak Paks aluminum sulfate tetradecahydrate, calcium acetate monohydrate POWDER, FOR SOLUTION TOPICAL 20130115 OTC MONOGRAPH FINAL part347 Pedinol Pharmacal, Inc. ALUMINUM ACETATE 615 mg/1 N 20181231 0884-2592_1f3cb470-be48-4b11-859d-d451643663b9 0884-2592 HUMAN OTC DRUG Salactic Film salicylic acid LIQUID TOPICAL 19910101 OTC MONOGRAPH FINAL part358B Pedinol Pharmacal, Inc. SALICYLIC ACID 170 mg/mL N 20181231 0884-2893_6e6a9ca2-8d96-4bfc-9ab9-cfbb30021da8 0884-2893 HUMAN OTC DRUG Castellani Paint Phenol LIQUID TOPICAL 19720101 OTC MONOGRAPH NOT FINAL part333A Pedinol Pharmacal, Inc. PHENOL 15 mg/mL N 20181231 0884-2993_608a9b35-b37e-4011-985b-cf57c92cc566 0884-2993 HUMAN OTC DRUG Castellani Paint Phenol LIQUID TOPICAL 19720101 OTC MONOGRAPH NOT FINAL part333A Pedinol Pharmacal, Inc. PHENOL 15 mg/mL N 20181231 0884-5192_9b258d23-fbf5-4e82-a6ca-213c9e8f836e 0884-5192 HUMAN OTC DRUG Sal-Plant Gel salicylic acid GEL TOPICAL 19910101 OTC MONOGRAPH FINAL part358B Pedinol Pharmacal, Inc. SALICYLIC ACID .17 g/g N 20181231 0884-5493_b250f4a4-6fdf-4a91-b214-4447aec3bb33 0884-5493 HUMAN OTC DRUG Fungoid Tincture Treatment Kit miconazole nitrate KIT 19940101 OTC MONOGRAPH FINAL part333C Pedinol Pharmacal, Inc. N 20181231 0884-8211_5de36643-df2b-45b2-a6b1-b4b9b0d93446 0884-8211 HUMAN OTC DRUG Fungoid-D TOLNAFTATE CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part333C Pedinol Pharmacal, Inc. TOLNAFTATE 1 g/100g N 20181231 0904-0004_a1af3bde-c2d1-41bd-affd-6926bedefd1c 0904-0004 HUMAN OTC DRUG MI-ACID REGULAR STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 MAJOR Pharmaceuticals Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 0904-0005_5de3f791-9357-94f7-e053-2991aa0a5b4e 0904-0005 HUMAN OTC DRUG MI-ACID MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 MAJOR Pharmaceuticals Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 0904-0012_859ea651-8ab7-4821-bc28-d65fc5f43131 0904-0012 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 0904-0049_5fc4a55f-3f72-4ed3-83bd-2d14219013c9 0904-0049 HUMAN OTC DRUG formula em Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 19940415 UNAPPROVED DRUG OTHER Major Pharmaceuticals DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 0904-0053_ab3c88c9-c759-4b55-af47-73121f177693 0904-0053 HUMAN OTC DRUG Rabofen DM Guaifenesin and Dextromethorphan Hydrobromide SOLUTION ORAL 20040101 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 0904-0201_05aada83-daf5-4031-a0ea-a0ca3caeeb24 0904-0201 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA085968 Major Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0904-0202_05aada83-daf5-4031-a0ea-a0ca3caeeb24 0904-0202 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA085968 Major Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 0904-0250_86bbb917-1726-473e-a444-e3b5551f0c1a 0904-0250 HUMAN OTC DRUG Aprodine Pseudoephedrine HCl and Tripolidine TABLET, FILM COATED ORAL 19930109 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 60; 2.5 mg/1; mg/1 N 20181231 0904-0357_4b87e9e9-9736-4918-8780-fa7448b39fb2 0904-0357 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070320 ANDA ANDA040786 Major Pharmaceuticals HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0904-0358_4b87e9e9-9736-4918-8780-fa7448b39fb2 0904-0358 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070320 ANDA ANDA040787 Major Pharmaceuticals HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0904-0359_4b87e9e9-9736-4918-8780-fa7448b39fb2 0904-0359 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070320 ANDA ANDA040788 Major Pharmaceuticals HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0904-0427_b8fe4603-402a-415e-9269-5542977991e2 0904-0427 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19841101 ANDA ANDA062396 Major Pharmaceuticals DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 0904-0428_92c31d61-513e-4d0b-9bbf-0fd3d41ffef9 0904-0428 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20080805 ANDA ANDA062396 Major Pharmaceuticals DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0904-0430_0a8551b6-ba90-4978-90a0-5cd72c1cc236 0904-0430 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 Major Pharmaceuticals DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 0904-0478_37d4b88e-89ba-48fa-aba3-302fe6b3c91f 0904-0478 HUMAN OTC DRUG Mintox Plus Tabs Aluminum Hydroxide, Magnesium Hydroxide, Simethicone TABLET, CHEWABLE ORAL 20070314 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 25 mg/1; mg/1; mg/1 N 20181231 0904-0560_053f068b-2362-41e7-886c-488fb9111011 0904-0560 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20050407 20190111 ANDA ANDA084903 Major Pharmaceuticals PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0904-0643_83d386b4-cc36-454e-8208-8fe4bf1d2883 0904-0643 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20040129 UNAPPROVED DRUG OTHER Major Pharmaceuticals NITROGLYCERIN 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0904-0644_83d386b4-cc36-454e-8208-8fe4bf1d2883 0904-0644 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20040129 UNAPPROVED DRUG OTHER Major Pharmaceuticals NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0904-0647_83d386b4-cc36-454e-8208-8fe4bf1d2883 0904-0647 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20040129 UNAPPROVED DRUG OTHER Major Pharmaceuticals NITROGLYCERIN 9 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 0904-0722_11969a53-61da-436b-853d-f0f2a9f1495d 0904-0722 HUMAN OTC DRUG Tolnaftate TOLNAFTATE CREAM TOPICAL 20100211 OTC MONOGRAPH FINAL part333C Major Pharmaceuticals TOLNAFTATE 10 mg/g N 20181231 0904-0726_5de17274-3858-7d24-e053-2991aa0acede 0904-0726 HUMAN OTC DRUG TOLNAFTATE ANTIFUNGAL TOLNAFTATE POWDER TOPICAL 20111101 OTC MONOGRAPH FINAL part333C Major Pharmaceuticals TOLNAFTATE 1 g/100g N 20181231 0904-0734_fcd39065-1522-4489-bed2-219140c4463f 0904-0734 HUMAN OTC DRUG TRIPLE ANTIBIOTIC Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate OINTMENT TOPICAL 20110601 OTC MONOGRAPH FINAL part333B Major Pharmaceuticals BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 0904-0788_5de3b05e-9882-64ec-e053-2a91aa0a7636 0904-0788 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20101208 OTC MONOGRAPH NOT FINAL part334 MAJOR Pharmaceuticals Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0904-0789_5de22a88-989a-7476-e053-2a91aa0adc96 0904-0789 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20110606 OTC MONOGRAPH NOT FINAL part334 MAJOR Pharmaceuticals Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 0904-1055_73677741-10d7-4abe-95c9-1b498485d1fd 0904-1055 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20060223 ANDA ANDA072264 Major Pharmaceuticals BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0904-1056_73677741-10d7-4abe-95c9-1b498485d1fd 0904-1056 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20060216 ANDA ANDA072265 Major Pharmaceuticals BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0904-1057_73677741-10d7-4abe-95c9-1b498485d1fd 0904-1057 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20060216 ANDA ANDA072266 Major Pharmaceuticals BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0904-1102_75921260-fe19-4670-8c2f-988f0c3bd13e 0904-1102 HUMAN OTC DRUG Major Povidone Iodine POVIDONE-IODINE OINTMENT TOPICAL 20060814 OTC MONOGRAPH FINAL part333C Major Pharmaceuticals POVIDONE-IODINE 100 mg/g N 20181231 0904-1103_91be52a6-3202-4628-a3b0-7bdaf920cbf8 0904-1103 HUMAN OTC DRUG povidone iodine povidone iodine SOLUTION TOPICAL 20111221 OTC MONOGRAPH FINAL part333C Major Pharmaceuticals POVIDONE-IODINE 100 mg/mL N 20181231 0904-1228_c279c6ce-bd87-4ffe-a709-6721a53ba364 0904-1228 HUMAN OTC DRUG banophen Diphenhydramine HCl LIQUID ORAL 20061120 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 0904-1313_9ce71b9b-524c-4f9e-b5da-4c057b1421a6 0904-1313 HUMAN OTC DRUG Bismatrol Bismuth Subsalicylate LIQUID ORAL 20080530 OTC MONOGRAPH FINAL part335 Major Pharmaceuticals BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 0904-1314_24699930-4a45-423e-8a4d-1f23804c2e6e 0904-1314 HUMAN OTC DRUG Bismatrol Bismuth Subsalicylate LIQUID ORAL 20090105 OTC MONOGRAPH FINAL part335 Major Pharmaceuticals BISMUTH SUBSALICYLATE 525 mg/15mL N 20181231 0904-1315_3fb4129f-1a84-4de8-8d78-439fa9af91f8 0904-1315 HUMAN OTC DRUG Bismatrol Bismuth subsalicylate TABLET, CHEWABLE ORAL 20030103 OTC MONOGRAPH FINAL part335 Major Pharmaceuticals BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 0904-1453_3d4ac4d3-d028-477a-aa5b-8d2829cd30b7 0904-1453 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19980808 ANDA ANDA070027 Major Pharmaceuticals METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20191231 0904-1982_ec14964a-9b19-415c-8e62-bb685323b089 0904-1982 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20110421 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 325 mg/1 N 20181231 0904-1983_46002352-2e0d-184d-e054-00144ff88e88 0904-1983 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET, FILM COATED ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 500 mg/1 N 20181231 0904-1985_712f4359-c7f3-4e47-a50c-c435bd6dd594 0904-1985 HUMAN OTC DRUG Childrens MAPAP Acetaminophen LIQUID ORAL 20150301 OTC MONOGRAPH NOT FINAL part343 Major ACETAMINOPHEN 160 mg/5mL N 20181231 0904-1987_60df41d6-9541-a6d9-e053-2991aa0a5198 0904-1987 HUMAN OTC DRUG MAPAP Extra Strength Acetaminophen CAPSULE ORAL 19971222 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 500 mg/1 N 20181231 0904-1988_1d89e7c8-51b6-465a-9a09-cc9be70c3f4b 0904-1988 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 500 mg/1 N 20181231 0904-2009_aa02bafc-1043-4f8c-bb09-88b76bf2bb2a 0904-2009 HUMAN OTC DRUG aspirin regular strength regular strength Aspirin TABLET ORAL 20060524 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ASPIRIN 325 mg/1 E 20171231 0904-2011_d54c9736-fb05-4d11-bf4a-b7ff6367bde6 0904-2011 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals Inc ASPIRIN 325 mg/1 N 20181231 0904-2013_c5ad5f7c-8f63-4453-b66f-b962a0e1f5ed 0904-2013 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals Inc ASPIRIN 325 mg/1 N 20181231 0904-2015_717d8652-7c1b-488b-9a5c-7a7588389d60 0904-2015 HUMAN OTC DRUG Tri-Buffered Aspirin Aspirin TABLET, FILM COATED ORAL 19900330 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ASPIRIN 325 mg/1 N 20181231 0904-2019_181e1c0c-02ce-40d7-bee0-5aa9c89d3d15 0904-2019 HUMAN OTC DRUG Aspirin Thin coated Aspirin TABLET ORAL 20140507 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ASPIRIN 325 mg/1 N 20181231 0904-2035_3a5c8263-bc88-43f8-817f-3508867d4442 0904-2035 HUMAN OTC DRUG Banophen Diphenhydramine HCl CAPSULE ORAL 19900315 20200915 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0904-2051_eb26ccbd-b1cb-4502-9af5-53c3b98a0f1a 0904-2051 HUMAN OTC DRUG Driminate Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Major Pharmaceuticals DIMENHYDRINATE 50 mg/1 N 20181231 0904-2056_0d915615-47e3-462a-aaf5-cc557a711f10 0904-2056 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20090102 OTC MONOGRAPH FINAL part336 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 0904-2151_cf0214ec-ad52-4ea3-bfab-28df6af1c6b2 0904-2151 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20040203 ANDA ANDA086066 Major Pharmaceuticals ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 0904-2154_cf0214ec-ad52-4ea3-bfab-28df6af1c6b2 0904-2154 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20040203 ANDA ANDA088088 Major Pharmaceuticals ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 0904-2244_0f781141-46a6-4297-952f-cf72110c776d 0904-2244 HUMAN OTC DRUG DOK DOCUSATE SODIUM TABLET, FILM COATED ORAL 20110421 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM 100 mg/1 N 20181231 0904-2364_a87623d5-599d-44b1-ae44-b16570649e17 0904-2364 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19760811 ANDA ANDA085159 Major Pharmaceuticals METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0904-2365_a87623d5-599d-44b1-ae44-b16570649e17 0904-2365 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19760818 ANDA ANDA085123 Major Pharmaceuticals METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0904-2500_e8b969b2-4eec-4635-bc74-f2136193e35e 0904-2500 HUMAN OTC DRUG FIBER TABS calcium polycarbophil TABLET ORAL 20100909 OTC MONOGRAPH FINAL part334 Major Pharmaceuticals CALCIUM POLYCARBOPHIL 500 mg/1 N 20181231 0904-2528_d03486cb-f635-4ba0-b0bc-65835862bc16 0904-2528 HUMAN OTC DRUG lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070816 OTC MONOGRAPH FINAL part358G Major Pharmaceuticals PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL N 20181231 0904-2533_b80628c5-62a4-4c62-a066-52695e3dbcad 0904-2533 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20130107 OTC MONOGRAPH FINAL part347 Major Pharmaceuticals FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 0904-2666_57a5115d-182a-4bc2-a970-a02abd89bf38 0904-2666 HUMAN OTC DRUG Infant Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20070501 OTC MONOGRAPH FINAL part334 Major Pharmaceuticals GLYCERIN 1.3 g/1 E 20171231 0904-2667_cd049527-3bfc-4c6c-86c0-3f67f68539d1 0904-2667 HUMAN OTC DRUG Adult Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20070501 OTC MONOGRAPH FINAL part334 Major Pharmaceuticals GLYCERIN 1.614 g/1 E 20171231 0904-2674_79c73b09-cff8-4376-9416-a581447f00c1 0904-2674 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 19730618 ANDA ANDA083365 Major Pharmaceuticals HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0904-2720_60f0eb5e-9087-7d0a-e053-2a91aa0a7d12 0904-2720 HUMAN PRESCRIPTION DRUG K-Vescent Efffervescent Potassium Bicarbonate TABLET, EFFERVESCENT ORAL 20050422 UNAPPROVED DRUG OTHER Major Pharmaceuticals POTASSIUM BICARBONATE 25 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0904-2725_98e895d6-717d-4f81-9376-ebf3ad0c39e2 0904-2725 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20090811 ANDA ANDA076899 Major Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 0904-2728_296bc895-21c6-4d94-8e8b-6d1be836d713 0904-2728 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfaccetamide Sodium SOLUTION/ DROPS OPHTHALMIC 20040701 ANDA ANDA040066 Major Pharmaceuticals SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 0904-2821_9e3cd6fc-1a81-4805-b640-6d4ceab0e041 0904-2821 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20040203 ANDA ANDA071655 Major Pharmaceuticals OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 0904-2920_728d84e6-e446-4fc6-a016-e3cb6e3509f2 0904-2920 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070995 Major Pharmaceuticals VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 0904-2924_728d84e6-e446-4fc6-a016-e3cb6e3509f2 0904-2924 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 Major Pharmaceuticals VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 0904-2992_03f51762-e9ed-4020-a9d0-9938987fa656 0904-2992 HUMAN OTC DRUG OptiClear Tetrahydrozoline HCl SOLUTION/ DROPS OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 0904-2995_7c50e7f2-1208-4f19-9807-4ab0dd314d3b 0904-2995 HUMAN PRESCRIPTION DRUG Cortomycin Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 19951030 ANDA ANDA064068 Major Pharmaceuticals NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE 3.5; 10000; 400; 10 mg/g; [USP'U]/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0904-3006_e1866f0d-e163-4fb5-a988-080ce6179535 0904-3006 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19960726 ANDA ANDA040069 Major Pharmaceuticals DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0904-3012_0ea2cee7-197e-405b-a7d4-f470a69a5178 0904-3012 HUMAN PRESCRIPTION DRUG NEOCIDIN Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 Major Pharmaceuticals NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] E 20171231 0904-3016_b7aa0bae-255b-4792-a963-6606370a175f 0904-3016 HUMAN PRESCRIPTION DRUG Neocidin Neomycin and Polymyxin B Sulfates and Gramicidin SOLUTION/ DROPS OPHTHALMIC 20040607 ANDA ANDA064047 Major Pharmaceuticals NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN 1.75; 10000; .025 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 0904-3017_41cfa382-d4ae-43c5-83a5-1ecc635d109b 0904-3017 HUMAN PRESCRIPTION DRUG Cortomycin Neomycin and Polymyxin B Sulfates and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 Major Pharmaceuticals HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 0904-3141_559b3666-096b-4a96-9396-3305c552fb1a 0904-3141 HUMAN PRESCRIPTION DRUG Cortomycin Neomycin and Polymyxin B Sulfates and Hydrocortisone SOLUTION/ DROPS OPHTHALMIC 20040601 ANDA ANDA064053 Major Pharmaceuticals NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 0904-3365_0e5b53f6-c4a1-4112-93a2-99920c39fb99 0904-3365 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19980721 ANDA ANDA072234 Major Pharmaceuticals BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 0904-3524_040850b0-68c0-4160-b3a8-271e7ec4cde9 0904-3524 HUMAN PRESCRIPTION DRUG Borofair Acetic Acid in Aqueous Aluminum Acetate SOLUTION/ DROPS AURICULAR (OTIC) 19940225 ANDA ANDA040063 Major Pharmaceuticals ACETIC ACID 2 mg/mL E 20171231 0904-3571_93b29266-3726-425a-9f64-c99601594fab 0904-3571 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20040216 ANDA ANDA072423 Major Pharmaceuticals MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 0904-3854_d917d769-cd71-4b65-83c4-a1430aee2ce5 0904-3854 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET, CHEWABLE ORAL 20100322 ANDA ANDA075712 Major Pharmaceuticals CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0904-4040_ec4d7f14-c319-4d95-9fe2-93f6cd133652 0904-4040 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 20071212 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ASPIRIN 81 mg/1 N 20181231 0904-4062_e083f340-a1d1-4c81-ba7c-e3c0968be3f8 0904-4062 HUMAN OTC DRUG Oral Peroxide carbamide peroxide LIQUID ORAL 20111125 OTC MONOGRAPH NOT FINAL part356 Major Pharmaceuticals CARBAMIDE PEROXIDE .1 mg/mL E 20171231 0904-4274_0a096e0b-80fc-438e-98c0-530b511114ae 0904-4274 HUMAN OTC DRUG Sleep Tabs Diphenhydramine HCl TABLET ORAL 19900410 OTC MONOGRAPH FINAL part338 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0904-4277_5c3afc2b-6725-4d45-b543-74ac4073cd25 0904-4277 HUMAN OTC DRUG Isopropyl alcohol Prep Pad isopropyl alcohol SWAB TOPICAL 20010901 OTC MONOGRAPH NOT FINAL part333 Major Pharmaceuticals ISOPROPYL ALCOHOL .7 mL/1 E 20171231 0904-5017_d639b093-9907-4b20-a3a1-c19bfcedb5d7 0904-5017 HUMAN OTC DRUG LiquiTears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20111209 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals POLYVINYL ALCOHOL 14 mg/mL E 20171231 0904-5018_fca5080f-e23d-40d5-861a-fe53b8d96028 0904-5018 HUMAN OTC DRUG Natural Balance Tears Hypromellose SOLUTION/ DROPS OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals HYPROMELLOSE 2910 (3 MPA.S) 4 mg/mL E 20171231 0904-5050_c7564dfb-f771-40dc-ad3e-f05364eba7d7 0904-5050 HUMAN OTC DRUG Pedia Relief Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID ORAL 19970105 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals, Inc CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 1; 15; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 0904-5053_e008f9d9-da2d-4aaa-9b78-bb7919e8004a 0904-5053 HUMAN OTC DRUG SudoGest Pseudoephedrine HCl TABLET, FILM COATED ORAL 19810825 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 0904-5058_facb8f98-cce8-47cb-a12b-868e5874240f 0904-5058 HUMAN OTC DRUG Biscolax Laxative Bisacodyl SUPPOSITORY RECTAL 20120824 OTC MONOGRAPH NOT FINAL part334 Major BISACODYL 10 mg/1 N 20181231 0904-5059_55dcc7c5-f1dc-430c-8ada-49ba8ff593a4 0904-5059 HUMAN OTC DRUG Medi-Pads witch hazel SOLUTION RECTAL; TOPICAL 20111025 OTC MONOGRAPH FINAL part346 Major Pharmaceuticals WITCH HAZEL 500 mg/1 N 20181231 0904-5068_aac82831-b806-4a59-a81c-c4c3c6e43564 0904-5068 HUMAN OTC DRUG Mi-Acid Gas Relief Simethicone TABLET, CHEWABLE ORAL 20110302 OTC MONOGRAPH FINAL part332 Major Pharmaceuticals DIMETHICONE 80 mg/1 N 20181231 0904-5098_71230489-6c89-4660-b18a-747699ec6e7c 0904-5098 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20030821 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g N 20181231 0904-5115_c2910f8d-6036-4893-b1e2-337d7ead85cb 0904-5115 HUMAN OTC DRUG Mi Acid Calcium carbonate, Magnesium hydroxide TABLET, CHEWABLE ORAL 20030103 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 700; 300 mg/1; mg/1 N 20181231 0904-5125_60d561a4-e749-4242-b000-b72d4a7969e6 0904-5125 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19841207 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 N 20181231 0904-5135_ebb15a86-4795-4d6d-9eca-435db45be3d8 0904-5135 HUMAN OTC DRUG Pain Reliever Plus Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0904-5154_7c0717aa-a8a4-47fe-9065-28167aba1cd1 0904-5154 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET ORAL 20091005 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals GUAIFENESIN 200 mg/1 N 20181231 0904-5165_5df49a61-0334-b972-e053-2a91aa0ad5ed 0904-5165 HUMAN OTC DRUG Senna-Lax SENNOSIDES A AND B TABLET, FILM COATED ORAL 20110504 20180531 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals SENNOSIDES A AND B 8.6 mg/1 N 20181231 0904-5168_a9f844af-6887-4496-8c64-721357a4a5bb 0904-5168 HUMAN OTC DRUG LubriFresh P.M. white petrolatum mineral oil OINTMENT OPHTHALMIC 20111209 OTC MONOGRAPH FINAL part349 Major Pharaceuticals MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g E 20171231 0904-5174_039a6fb0-a4b8-4ed0-a6d9-ef58f0b43fe5 0904-5174 HUMAN OTC DRUG Banophen diphenhydramine hydrochloride LIQUID ORAL 20120824 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 0904-5180_6e32a54e-da29-47b1-b0fd-c0828aadb9a2 0904-5180 HUMAN OTC DRUG Tussin Sugar Free Cough Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090107 20190601 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 0904-5199_60df683a-1503-0e24-e053-2991aa0adb13 0904-5199 HUMAN OTC DRUG Natural Fiber Therapy Natural Laxative Natural Laxative Psyllium Husk POWDER, FOR SOLUTION ORAL 20110802 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals PSYLLIUM HUSK 3.4 g/7g N 20181231 0904-5200_60df53a6-889f-cdaa-e053-2a91aa0a15c3 0904-5200 HUMAN OTC DRUG Natural Fiber Therapy Natural Laxative Psyllium Husk POWDER, FOR SOLUTION ORAL 20110802 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals PSYLLIUM HUSK 3.4 g/7g N 20181231 0904-5222_0e5b53f6-c4a1-4112-93a2-99920c39fb99 0904-5222 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19980721 ANDA ANDA072235 Major Pharmaceuticals BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 0904-5256_5df654b7-01ef-4e5a-e053-2a91aa0a8063 0904-5256 HUMAN OTC DRUG Childrens Chewable Mapap Acetaminophen TABLET, CHEWABLE ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 80 mg/1 N 20181231 0904-5259_87106483-2d4b-4d98-b080-2840a1934eca 0904-5259 HUMAN OTC DRUG Major Thera-Gel Therapeutic Anti-Dandruff Coal Tar SHAMPOO TOPICAL 20070901 OTC MONOGRAPH FINAL part358H Major Pharmaceuticals COAL TAR .5 mL/100mL E 20171231 0904-5282_3e7ad34e-a072-4f54-8f77-82aab925ef3d 0904-5282 HUMAN PRESCRIPTION DRUG RIFAMPIN RIFAMPIN CAPSULE ORAL 20091007 ANDA ANDA064150 Major Pharmaceuticals RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20191231 0904-5304_9aee4d17-7248-4dcf-b797-c3080530f139 0904-5304 HUMAN OTC DRUG Major Prep Hemorrhoidal hard fat, phenylephrine HCl SUPPOSITORY RECTAL 20080328 OTC MONOGRAPH FINAL part346 Major Pharmaceuticals PHENYLEPHRINE HYDROCHLORIDE; FAT, HARD 74; 2 mg/2.5g; g/2.5g N 20181231 0904-5306_0d915615-47e3-462a-aaf5-cc557a711f10 0904-5306 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20090102 OTC MONOGRAPH FINAL part336 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0904-5307_7a250718-793e-44e1-8000-14869551f8e4 0904-5307 HUMAN OTC DRUG Banophen diphenhydramine hcl CAPSULE ORAL 20091102 OTC MONOGRAPH FINAL part336 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 0904-5309_c6ba5eb6-ed9e-4577-b846-e6382ad96f99 0904-5309 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 19990207 ANDA ANDA074937 Major Pharmaceuticals IBUPROFEN 100 mg/5mL N 20181231 0904-5314_03f42d2a-cedc-4913-bced-3766cbf176e1 0904-5314 HUMAN OTC DRUG Sodium Chloride Hypertonicity sodium chloride SOLUTION OPHTHALMIC 20110101 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals SODIUM CHLORIDE 50 mg/mL E 20171231 0904-5315_09891c58-857b-4041-8033-46675e6ea9db 0904-5315 HUMAN OTC DRUG Sodium Chloride Hypertonicity sodium chloride OINTMENT OPHTHALMIC 20110101 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals SODIUM CHLORIDE 50 mg/g E 20171231 0904-5351_ddc848b7-bea5-4cce-9a13-638598e0250b 0904-5351 HUMAN OTC DRUG SudoGest Chlorpheniramine maleate, pseudoephedrine HCl TABLET ORAL 19921216 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 4; 60 mg/1; mg/1 N 20181231 0904-5354_9758d886-bd58-4eb2-a827-fa8e7fee2b7c 0904-5354 HUMAN OTC DRUG Banophen Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 0904-5365_4498104a-e41d-41d9-9aed-01904d91af87 0904-5365 HUMAN OTC DRUG Acid Gone Antacid Extra Strength aluminum hydroxide and magnesium carbonate TABLET, CHEWABLE ORAL 20140606 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 N 20181231 0904-5377_e3f4d92c-13e4-4c91-804b-c805f6f5830d 0904-5377 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals WATER 99.05 mL/100mL N 20181231 0904-5392_dc040fcb-feb5-4101-b9eb-7cc464111d05 0904-5392 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 20190531 ANDA ANDA074052 Major Pharmaceuticals ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 0904-5415_83bc46df-fd3c-4997-a530-e0f985289433 0904-5415 HUMAN OTC DRUG Miconazole 3 Combination Pack miconazole nitrate KIT VAGINAL 20021202 ANDA ANDA074926 Major Pharmaceuticals N 20181231 0904-5448_0dae62f5-6987-4e66-b1af-e91a5d6a5f3b 0904-5448 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 19990610 ANDA ANDA075191 Major Pharmaceuticals PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20191231 0904-5458_5c251b09-f330-4c6e-ad8f-0322912be09a 0904-5458 HUMAN OTC DRUG MAJOR Extra Strength Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 19980916 OTC MONOGRAPH FINAL part332 Major Pharmaceuticals DIMETHICONE 125 mg/1 E 20171231 0904-5463_30293465-3322-46e1-b3e1-b1d0055624e6 0904-5463 HUMAN OTC DRUG ibuprofen ibuprofen SUSPENSION ORAL 20000108 ANDA ANDA075217 Major Pharmaceuticals IBUPROFEN 50 mg/1.25mL N 20181231 0904-5495_7ed1f92c-577a-4354-8b59-8b97e09299d3 0904-5495 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089884 Harvard Drug Group, LLC NITROGLYCERIN .2 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 0904-5496_7ed1f92c-577a-4354-8b59-8b97e09299d3 0904-5496 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089885 Harvard Drug Group, LLC NITROGLYCERIN .4 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 0904-5497_7ed1f92c-577a-4354-8b59-8b97e09299d3 0904-5497 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089886 Harvard Drug Group, LLC NITROGLYCERIN .6 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 0904-5502_3d9081b5-56cf-4ec3-989a-e05a25a764d4 0904-5502 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Major Pharmaceuticals ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 0904-5512_a68f4aa3-d072-49f2-9782-c41d116e8323 0904-5512 HUMAN OTC DRUG Senna/Docusate Sodium Docusate sodium and Sennosides TABLET, FILM COATED ORAL 20110616 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 0904-5522_a9c99f33-c97e-47fc-862e-df92a831808f 0904-5522 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Major Pharmaceuticals DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0904-5523_a9c99f33-c97e-47fc-862e-df92a831808f 0904-5523 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Major Pharmaceuticals DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0904-5524_a9c99f33-c97e-47fc-862e-df92a831808f 0904-5524 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Major Pharmaceuticals DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0904-5529_5f5734ab-5010-48d3-85c2-87e374f24079 0904-5529 HUMAN OTC DRUG heartburn relief original strength Famotidine TABLET ORAL 20090909 ANDA ANDA075400 Major Pharmaceuticals FAMOTIDINE 10 mg/1 N 20181231 0904-5532_9857e24e-871d-445d-8b52-c18643aa32bd 0904-5532 HUMAN OTC DRUG Cromolyn Sodium Cromolyn Sodium SPRAY, METERED NASAL 20010703 ANDA ANDA075702 Major Pharmaceuticals CROMOLYN SODIUM 5.2 mg/mL N 20181231 0904-5535_208389e6-ebbc-4e23-8312-e68bb6f697f0 0904-5535 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20081108 ANDA ANDA074410 Major Pharmaceuticals NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-5536_208389e6-ebbc-4e23-8312-e68bb6f697f0 0904-5536 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20081108 ANDA ANDA074410 Major Pharmaceuticals NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-5537_208389e6-ebbc-4e23-8312-e68bb6f697f0 0904-5537 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20091120 ANDA ANDA074410 Major Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-5551_aded0249-dd62-40f3-81de-e2da676d1b0a 0904-5551 HUMAN OTC DRUG Banophen Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0904-5553_c6d5b9f7-9528-4343-97ae-05410097f85e 0904-5553 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET, FILM COATED ORAL 20090610 ANDA ANDA075718 Major Pharmaceuticals FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0904-5554_c6d5b9f7-9528-4343-97ae-05410097f85e 0904-5554 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET, FILM COATED ORAL 20090610 ANDA ANDA075718 Major Pharmaceuticals FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0904-5559_053f068b-2362-41e7-886c-488fb9111011 0904-5559 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20050407 ANDA ANDA084903 Major Pharmaceuticals PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0904-5572_c47beec2-11c2-4e30-a78c-d61b14c9dea0 0904-5572 HUMAN OTC DRUG MAJOR ULTRA STRENGTH GAS RELIEF Simethicone CAPSULE, LIQUID FILLED ORAL 20100712 OTC MONOGRAPH FINAL part332 Major Pharmaceuticals DIMETHICONE 180 mg/1 E 20171231 0904-5577_82073b75-e8b7-4abb-a92a-74226987e7e6 0904-5577 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20020403 ANDA ANDA074937 Major Pharmaceuticals IBUPROFEN 100 mg/5mL N 20181231 0904-5590_208389e6-ebbc-4e23-8312-e68bb6f697f0 0904-5590 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040401 ANDA ANDA076494 Major Pharmaceuticals NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-5591_208389e6-ebbc-4e23-8312-e68bb6f697f0 0904-5591 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040401 ANDA ANDA076494 Major Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-5609_3d9081b5-56cf-4ec3-989a-e05a25a764d4 0904-5609 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Major Pharmaceuticals ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 0904-5610_3d9081b5-56cf-4ec3-989a-e05a25a764d4 0904-5610 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Major Pharmaceuticals ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 0904-5611_3d9081b5-56cf-4ec3-989a-e05a25a764d4 0904-5611 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Major Pharmaceuticals ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 0904-5631_56cd6f1a-efd6-416a-8473-7e9fb73c08d0 0904-5631 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Major Pharmaceuticals GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0904-5632_56cd6f1a-efd6-416a-8473-7e9fb73c08d0 0904-5632 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Major Pharmaceuticals GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0904-5633_56cd6f1a-efd6-416a-8473-7e9fb73c08d0 0904-5633 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Major Pharmaceuticals GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0904-5643_98fe9ad9-4f5b-4c55-8ef8-456511bdf0bb 0904-5643 HUMAN OTC DRUG Senna/Docusate Sodium Docusate sodium and Sennosides TABLET, FILM COATED ORAL 20100101 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 0904-5656_2084dea3-f599-4f1b-b4a8-0445493f760f 0904-5656 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20061120 ANDA ANDA070974 Major Pharmaceuticals CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 0904-5657_2084dea3-f599-4f1b-b4a8-0445493f760f 0904-5657 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20061120 ANDA ANDA070975 Major Pharmaceuticals CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 0904-5658_2084dea3-f599-4f1b-b4a8-0445493f760f 0904-5658 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20061120 ANDA ANDA070976 Major Pharmaceuticals CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 0904-5666_80110b85-6709-44b9-95c0-ba82f0e82871 0904-5666 HUMAN OTC DRUG phosphate dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20100602 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.9; 7.2 g/15mL; g/15mL E 20171231 0904-5675_4c187a13-b71e-4735-ac17-c62f8c9a2f8c 0904-5675 HUMAN OTC DRUG FIBER THERAPY methylcellulose POWDER, FOR SOLUTION ORAL 20080418 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals METHYLCELLULOSE (4000 MPA.S) 2 g/19g N 20181231 0904-5676_43ead0ce-1382-4b10-9a1e-04c62599696a 0904-5676 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Major Pharmaceuticals PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0904-5677_43ead0ce-1382-4b10-9a1e-04c62599696a 0904-5677 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Major Pharmaceuticals PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0904-5678_43ead0ce-1382-4b10-9a1e-04c62599696a 0904-5678 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Major Pharmaceuticals PAROXETINE HYDROCHLORIDE ANHYDROUS 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0904-5679_43ead0ce-1382-4b10-9a1e-04c62599696a 0904-5679 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Major Pharmaceuticals PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0904-5684_e89644a9-c46f-40d7-8bc3-85e33535ffe7 0904-5684 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20080228 ANDA ANDA076048 Major Pharmaceuticals OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 0904-5694_5f8d597b-7afa-1c26-e053-2991aa0a6bc1 0904-5694 HUMAN OTC DRUG Major Extra Strength Cold and Hot Pain Relief Therapy Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals MENTHOL 750 mg/1 N 20181231 0904-5709_f45cb097-f6f9-4a76-812c-e09a6cc01b90 0904-5709 HUMAN OTC DRUG KAO-TIN PEPPERMINT FLAVOR bismuth subsalicylate LIQUID ORAL 20110214 OTC MONOGRAPH FINAL part335 MAJOR Pharmaceuticals Inc. BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 0904-5711_864595a4-57c4-4de8-b19b-e00a6eea9e40 0904-5711 HUMAN OTC DRUG Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20090317 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals OXYMETAZOLINE HYDROCHLORIDE 5 g/100mL N 20181231 0904-5721_991a0bb2-ca05-45cd-b3fd-71a6638b5f73 0904-5721 HUMAN OTC DRUG MINTOX aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 MAJOR Pharmaceuticals Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 0904-5725_5df4a067-3a3e-5576-e053-2991aa0a2ec1 0904-5725 HUMAN OTC DRUG MINTOX MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 MAJOR Pharmaceuticals Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 0904-5728_002809bf-72cd-4a72-9002-828b2c2be77b 0904-5728 HUMAN OTC DRUG allergy Loratadine TABLET ORAL 20050221 ANDA ANDA076301 Major Pharmaceuticals LORATADINE 10 mg/1 N 20181231 0904-5731_f1496185-0d89-428c-92cd-24441a00868e 0904-5731 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20070711 OTC MONOGRAPH FINAL part347 Major PETROLATUM 1 g/g N 20181231 0904-5733_8fa741a5-ac43-464c-bcea-883c231ffa81 0904-5733 HUMAN OTC DRUG Sudogest PE Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 0904-5734_50109864-8d76-4c91-aa03-7b15c4fcd090 0904-5734 HUMAN OTC DRUG nicorelief Nicotine Polacrilex GUM, CHEWING ORAL 20050412 ANDA ANDA076775 Major Pharmaceuticals NICOTINE 2 mg/1 N 20181231 0904-5735_45bd4e09-7ca9-45b0-9ab0-7671ca9357f5 0904-5735 HUMAN OTC DRUG nicorelief Nicotine Polacrilex GUM, CHEWING ORAL 20050412 ANDA ANDA076789 Major Pharmaceuticals NICOTINE 4 mg/1 N 20181231 0904-5736_ba6ace63-0747-492a-abb1-bf27f1fcc208 0904-5736 HUMAN OTC DRUG Nicorelief Nicotine Polacrilex GUM, CHEWING ORAL 20050412 ANDA ANDA078325 Major Pharmaceuticals NICOTINE 2 mg/1 N 20181231 0904-5737_b60d8cbd-8c3d-416d-a7c9-ca04b9ef90d6 0904-5737 HUMAN OTC DRUG Nicorelief Nicotine Polacrilex GUM, CHEWING ORAL 20050412 ANDA ANDA078326 Major Pharmaceuticals NICOTINE 4 mg/1 N 20181231 0904-5751_c225e53b-f8ca-431c-8674-96557a523e32 0904-5751 HUMAN OTC DRUG Mapap Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050203 20201128 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 80 mg/1 N 20191231 0904-5752_031b9e82-80a6-46f7-893b-26678845d3a8 0904-5752 HUMAN OTC DRUG Robafen Cough Liquidgels Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20041001 20180827 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 E 20171231 0904-5754_410533a1-c88f-44a0-b3ef-f4d89751c696 0904-5754 HUMAN OTC DRUG Junior Mapap Acetaminophen TABLET, CHEWABLE ORAL 20050225 20201018 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 160 mg/1 N 20181231 0904-5758_a8123548-48a7-4b2d-9d19-74388b11ad95 0904-5758 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20051222 20181104 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals GUAIFENESIN 400 mg/1 E 20171231 0904-5763_f3ddec84-8e55-4918-bf79-300c17bf0bdb 0904-5763 HUMAN OTC DRUG Day Time Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20110325 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0904-5764_58c2fc45-cb2b-4d6a-85f7-b493f731174d 0904-5764 HUMAN OTC DRUG Major Night Time Multi Symptom cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120301 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 0904-5769_b7714dd9-99fd-4b7d-9892-5d2c9aac9d6d 0904-5769 HUMAN OTC DRUG mapap arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060216 ANDA ANDA075077 Major Pharmaceuticals ACETAMINOPHEN 650 mg/1 N 20181231 0904-5777_109dbef7-84b1-4be2-8d7e-c9ba4f6871ed 0904-5777 HUMAN OTC DRUG All-Nite Cold and Flu acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090218 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 0904-5779_33449f96-aa53-43d6-a772-33fe0af04601 0904-5779 HUMAN OTC DRUG KAO- TIN DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20111201 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE CALCIUM 240 mg/1 N 20181231 0904-5780_0e4e6213-8767-4f50-900c-ef27d159ca0a 0904-5780 HUMAN OTC DRUG Major Heartburn Relief Maximum Strength Famotidine TABLET ORAL 20060929 ANDA ANDA077351 Major Pharmaceuticals FAMOTIDINE 20 mg/1 N 20181231 0904-5781_71c45891-4c6c-4c27-ab75-18e4e5f0308d 0904-5781 HUMAN OTC DRUG DIBROMM with PE BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090107 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL E 20171231 0904-5782_96182b09-1204-4497-bd3d-696f73e8646c 0904-5782 HUMAN OTC DRUG DIBROMM DM BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20091107 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 1; 2.5; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 0904-5783_baae1600-7f4d-4de9-9a6e-6cf629a49600 0904-5783 HUMAN OTC DRUG Mapap Sinus Congestion and Pain Maximum Strength Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 0904-5784_7fa63cbc-7c74-48e3-934a-91045785ac05 0904-5784 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20070216 ANDA ANDA076001 Major Pharmaceuticals FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0904-5785_7fa63cbc-7c74-48e3-934a-91045785ac05 0904-5785 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20070216 ANDA ANDA076001 Major Pharmaceuticals FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0904-5786_c4054258-cc65-40ae-be1b-b142964cec20 0904-5786 HUMAN OTC DRUG Multi-Symptom Mapap Cold Formula Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0904-5788_1d1689cb-baa1-4e59-ab72-c25a6c8d1549 0904-5788 HUMAN OTC DRUG Natural Fiber Therapy Natural Laxative Natural Laxative Psyllium Husk POWDER, FOR SOLUTION ORAL 20110802 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals PSYLLIUM HUSK 3.4 g/7g N 20181231 0904-5789_684853a1-b3d0-4e00-b43a-b81128ec9164 0904-5789 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20070419 ANDA ANDA075677 Major Pharmaceuticals ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0904-5790_d0d83326-8d85-4d79-be82-75eafd5e4832 0904-5790 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20070209 ANDA ANDA077309 Major Pharmaceuticals ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 0904-5791_85db89b4-3aed-4c55-9f24-c765f516b631 0904-5791 HUMAN OTC DRUG Childrens Mapap Acetaminophen TABLET, CHEWABLE ORAL 20041206 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 80 mg/1 N 20181231 0904-5792_f982a2b5-19d2-4566-b5f9-e3bc459e03b3 0904-5792 HUMAN OTC DRUG Mucus Relief Sinus Guaifenesin and Phenylephrine HCl TABLET, FILM COATED ORAL 20060415 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 0904-5793_1b1d8e1d-f318-46d5-931a-36ff911308b0 0904-5793 HUMAN OTC DRUG LORATADINE Loratadine TABLET ORAL 20160622 ANDA ANDA076471 Major Pharmaceuticals LORATADINE 10 mg/1 N 20191231 0904-5794_0cfa0079-8df3-432a-a5ae-f0bec7d2aad9 0904-5794 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Extended Release metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20090610 ANDA ANDA076706 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 0904-5796_666e0fba-7739-49c7-b36a-52c9409cb755 0904-5796 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20080326 NDA NDA018569 Major Pharmaceuticals FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0904-5797_666e0fba-7739-49c7-b36a-52c9409cb755 0904-5797 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20080326 NDA NDA018569 Major Pharmaceuticals FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0904-5798_666e0fba-7739-49c7-b36a-52c9409cb755 0904-5798 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20080326 NDA NDA018569 Major Pharmaceuticals FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 0904-5800_7309e48c-6bd1-4535-94d2-f897a8585d0b 0904-5800 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 20190425 ANDA ANDA077752 Major Pharmaceuticals SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0904-5801_7309e48c-6bd1-4535-94d2-f897a8585d0b 0904-5801 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 20180630 ANDA ANDA077752 Major Pharmaceuticals SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0904-5802_7309e48c-6bd1-4535-94d2-f897a8585d0b 0904-5802 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 20190425 ANDA ANDA077752 Major Pharmaceuticals SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0904-5803_aa0c7100-9352-4990-9bd6-57bef533c1c7 0904-5803 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Major Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 0904-5806_d634e4e1-7b35-4f89-96ac-97d74cd36b0e 0904-5806 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Major Pharmaceuticals LORATADINE 10 mg/1 N 20181231 0904-5808_250b07d8-9392-4f87-98b0-1525201986d2 0904-5808 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 20180228 ANDA ANDA075994 Major Pharmaceuticals LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 0904-5809_250b07d8-9392-4f87-98b0-1525201986d2 0904-5809 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 20180331 ANDA ANDA075994 Major Pharmaceuticals LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 0904-5810_250b07d8-9392-4f87-98b0-1525201986d2 0904-5810 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 20180331 ANDA ANDA075994 Major Pharmaceuticals LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 0904-5811_250b07d8-9392-4f87-98b0-1525201986d2 0904-5811 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 20191130 ANDA ANDA075994 Major Pharmaceuticals LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 0904-5816_283236c6-59e6-4c97-a98f-6eaf1901297b 0904-5816 HUMAN OTC DRUG Mapap Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 500 mg/1 N 20181231 0904-5817_902ba955-1bd1-4000-9a22-ab85164bc1df 0904-5817 HUMAN OTC DRUG Cough and Cold Chlorpheniramine maleate, Dextromethorphan HBr TABLET, SUGAR COATED ORAL 20030503 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 0904-5831_7a4ac903-0cb0-446f-8506-baf7eef16093 0904-5831 HUMAN OTC DRUG All day Allergy d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080506 ANDA ANDA077170 Major Pharmaceuticals CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 0904-5832_f50650f9-fce0-464f-b537-178dd2f68f59 0904-5832 HUMAN OTC DRUG Major Ranitidine Maximum Strength Ranitidine TABLET ORAL 20080218 ANDA ANDA078653 Major Pharmaceuticals RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 0904-5833_af1334c2-c43b-4928-ba05-6a1f3def529e 0904-5833 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Major Pharmaceuticals LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 0904-5834_46101732-04cd-4c6f-992f-b90f56464368 0904-5834 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080229 NDA NDA022032 Major Pharmaceuticals OMEPRAZOLE 20 mg/1 N 20181231 0904-5836_fa0aeecc-6363-4567-96c7-1c76cbbe6b30 0904-5836 HUMAN OTC DRUG Alcohol Prep Pad with Benzocaine benzocaine SWAB TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 E 20171231 0904-5840_9c535488-a878-4ffd-aca4-49c461ccaea8 0904-5840 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20080509 ANDA ANDA040712 Major Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0904-5843_1874b9fb-ea3f-4444-a4b7-b20366a2a97a 0904-5843 HUMAN OTC DRUG Major Vitamin A and D Skin Protectant Petrolatum and Lanolin OINTMENT TOPICAL 20070901 OTC MONOGRAPH FINAL part347 Major Pharmaceuticals PETROLATUM; LANOLIN 53.4; 15.5 mL/100g; mL/100g N 20181231 0904-5847_7e260f1b-cc12-4df2-95b2-0d15216da083 0904-5847 HUMAN OTC DRUG Extra Strength Acetaminohpen Adult Rapid Burst Cherry Acetaminophen LIQUID ORAL 20090702 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 500 mg/5mL N 20181231 0904-5849_f633cec7-1625-47b5-8729-e8aa80ac1756 0904-5849 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0904-5850_f633cec7-1625-47b5-8729-e8aa80ac1756 0904-5850 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0904-5851_f633cec7-1625-47b5-8729-e8aa80ac1756 0904-5851 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0904-5852_0f66b9e4-7d52-a09f-2227-0f011022dc3f 0904-5852 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160622 ANDA ANDA078317 Major Pharmaceuticals CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0904-5852_a1a5e148-04ea-47a5-9202-b582b525b705 0904-5852 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA078317 Major Pharmaceuticals CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0904-5853_05291658-daac-4901-8061-db2172387ce4 0904-5853 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Major Pharmaceuticals IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-5854_05291658-daac-4901-8061-db2172387ce4 0904-5854 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Major Pharmaceuticals IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-5855_05291658-daac-4901-8061-db2172387ce4 0904-5855 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Major Pharmaceuticals IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-5857_a1631071-3e88-44d8-b74f-56a4821062ee 0904-5857 HUMAN OTC DRUG Analgesic Creme Rub Trolamine Salicylate 10% CREAM TOPICAL 20140510 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals TROLAMINE SALICYLATE 100 mg/g N 20181231 0904-5858_6df18e79-478d-472c-8023-584346248ca2 0904-5858 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Major Pharmaceuticals ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-5859_6df18e79-478d-472c-8023-584346248ca2 0904-5859 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Major Pharmaceuticals ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-5860_6df18e79-478d-472c-8023-584346248ca2 0904-5860 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Major Pharmaceuticals ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-5869_5df792df-f5af-3e0a-e053-2a91aa0a1320 0904-5869 HUMAN OTC DRUG DOK DOCUSATE SODIUM TABLET, FILM COATED ORAL 20110421 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM 100 mg/1 N 20181231 0904-5879_924ccf88-24b4-47d1-8b90-9bd7be3ac917 0904-5879 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20080214 ANDA ANDA078692 Major Pharmaceuticals CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 0904-5880_e7d640b7-e7f3-4c2e-a7eb-db7b3dc36bd6 0904-5880 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20080605 ANDA ANDA071135 Major Pharmaceuticals DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-5887_713c8681-71cd-4ac8-b94d-9ef33ca0378a 0904-5887 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20081113 ANDA ANDA089807 Major Pharmaceuticals THEOPHYLLINE ANHYDROUS 100 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 0904-5888_713c8681-71cd-4ac8-b94d-9ef33ca0378a 0904-5888 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20081113 ANDA ANDA089808 Major Pharmaceuticals THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 0904-5889_713c8681-71cd-4ac8-b94d-9ef33ca0378a 0904-5889 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20081113 ANDA ANDA089763 Major Pharmaceuticals THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 0904-5891_e8ebaec5-3f56-4626-8b01-43a532e222aa 0904-5891 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Major Pharmaceuticals PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0904-5892_e8ebaec5-3f56-4626-8b01-43a532e222aa 0904-5892 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Major Pharmaceuticals PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0904-5893_e8ebaec5-3f56-4626-8b01-43a532e222aa 0904-5893 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Major Pharmaceuticals PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0904-5894_5de14759-c5ac-817a-e053-2a91aa0ad770 0904-5894 HUMAN OTC DRUG INFANTS GAS RELIEF Simethicone SUSPENSION/ DROPS ORAL 20101207 OTC MONOGRAPH FINAL part332 MAJOR Pharmaceuticals Inc. DIMETHICONE 20 mg/.3mL N 20181231 0904-5904_a9c19d0e-4ea4-4fb4-a060-b41e4c614af3 0904-5904 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 MAJOR PHARMACEUTICALS INC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 0904-5905_a9c19d0e-4ea4-4fb4-a060-b41e4c614af3 0904-5905 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 MAJOR PHARMACEUTICALS INC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 0904-5921_07b29251-8d93-4ea2-8545-7b9063e97ce2 0904-5921 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20090610 ANDA ANDA077002 Major Pharmaceuticals DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0904-5922_07b29251-8d93-4ea2-8545-7b9063e97ce2 0904-5922 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20090610 ANDA ANDA077002 Major Pharmaceuticals DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 0904-5923_a2de6f88-0bdc-442a-8027-112700271cf3 0904-5923 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20090219 ANDA ANDA071207 Major Pharmaceuticals HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] E 20171231 0904-5924_a2de6f88-0bdc-442a-8027-112700271cf3 0904-5924 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20090219 ANDA ANDA071208 Major Pharmaceuticals HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] E 20171231 0904-5925_a2de6f88-0bdc-442a-8027-112700271cf3 0904-5925 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20090219 ANDA ANDA071209 Major Pharmaceuticals HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] E 20171231 0904-5928_45568cb7-a5c6-4d40-a5fd-834c870353b1 0904-5928 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA075133 Major Pharmaceuticals LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0904-5929_45568cb7-a5c6-4d40-a5fd-834c870353b1 0904-5929 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA075133 Major Pharmaceuticals LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0904-5930_45568cb7-a5c6-4d40-a5fd-834c870353b1 0904-5930 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA075133 Major Pharmaceuticals LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0904-5939_8193201f-4b27-4b07-b416-8124817eb0c9 0904-5939 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20090610 ANDA ANDA076009 Major Pharmaceuticals NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 0904-5940_8193201f-4b27-4b07-b416-8124817eb0c9 0904-5940 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20090610 ANDA ANDA076009 Major Pharmaceuticals NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 0904-5941_2597f884-d20a-40b7-9dd3-147462a04c47 0904-5941 HUMAN PRESCRIPTION DRUG Neomycin Sulfate Neomycin Sulfate TABLET ORAL 20090914 ANDA ANDA060304 Major Pharmaceuticals NEOMYCIN SULFATE 500 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 0904-5951_4fb01776-e2fe-47c5-a579-f56923a092e0 0904-5951 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20091102 ANDA ANDA040353 Major Pharmaceuticals SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 0904-5959_01575ac7-4967-40d8-b3fb-9fb33c424fb6 0904-5959 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20090410 ANDA ANDA065061 Major Pharmaceuticals CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 0904-5961_42579609-eccc-473c-8dd9-a94b94a74832 0904-5961 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA076502 Major Pharmaceuticals FEXOFENADINE HYDROCHLORIDE 30 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0904-5962_42579609-eccc-473c-8dd9-a94b94a74832 0904-5962 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA076502 Major Pharmaceuticals FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0904-5963_42579609-eccc-473c-8dd9-a94b94a74832 0904-5963 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA076502 Major Pharmaceuticals FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 0904-5980_0a415c46-7e3b-41f7-a64b-814fe08053ed 0904-5980 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100324 ANDA ANDA076045 Major Pharmaceuticals LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-5981_0a415c46-7e3b-41f7-a64b-814fe08053ed 0904-5981 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100324 ANDA ANDA076045 Major Pharmaceuticals LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-5982_0a415c46-7e3b-41f7-a64b-814fe08053ed 0904-5982 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100324 ANDA ANDA076045 Major Pharmaceuticals LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-5988_300272b1-8b53-4c43-b72d-f2820e1d0b38 0904-5988 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20100312 ANDA ANDA077836 Major Pharmaceuticals GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 0904-5990_3a88f295-bd1a-4252-9f9b-cff4c76e26cb 0904-5990 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090820 ANDA ANDA078705 Major Pharmaceuticals DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 0904-6004_4a92ffca-a913-4569-b088-5db685b557de 0904-6004 HUMAN OTC DRUG Ear Wax Remover CARBAMIDE PEROXIDE LIQUID AURICULAR (OTIC) 20090527 OTC MONOGRAPH FINAL part344 Major Pharmaceuticals CARBAMIDE PEROXIDE 65 mg/mL E 20171231 0904-6007_1beea6e1-bbd4-4a6e-9a73-be317956923d 0904-6007 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Major Pharmaceuticals LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-6008_1beea6e1-bbd4-4a6e-9a73-be317956923d 0904-6008 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Major Pharmaceuticals LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-6009_1beea6e1-bbd4-4a6e-9a73-be317956923d 0904-6009 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Major Pharmaceuticals LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-6010_55779dab-c6c4-4e25-8b06-aeb10c07b6a3 0904-6010 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20090610 ANDA ANDA065404 Major Pharmaceuticals AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 0904-6013_773ff83d-7806-4b4b-8ab4-ead208e187ce 0904-6013 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr and Guiafenesin TABLET, FILM COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 0904-6016_68d6091e-fb3f-419f-b279-11f240825b07 0904-6016 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20090610 ANDA ANDA076311 Major Pharmaceuticals TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 0904-6017_68d6091e-fb3f-419f-b279-11f240825b07 0904-6017 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20090610 ANDA ANDA076311 Major Pharmaceuticals TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 0904-6018_68d6091e-fb3f-419f-b279-11f240825b07 0904-6018 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20090610 ANDA ANDA076311 Major Pharmaceuticals TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 0904-6019_90209428-5187-45a1-b9af-ed8e83633c3a 0904-6019 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET ORAL 20100511 ANDA ANDA078917 Major Pharmaceuticals BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] E 20171231 0904-6021_5816d435-7b89-44b4-a012-d64adf02749c 0904-6021 HUMAN OTC DRUG Oral Pain Relief Anesthetic Anesthetic Benzocaine GEL ORAL 20090819 OTC MONOGRAPH NOT FINAL part356 Major Pharmaceuticals BENZOCAINE 200 mg/g N 20181231 0904-6025_fc5ffc2c-976e-4997-b856-9acffe62eb8d 0904-6025 HUMAN OTC DRUG peg 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091008 ANDA ANDA090685 Major Pharmaceuticals POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 0904-6041_93b20fd7-0d02-4ba4-bb38-bd11eab007be 0904-6041 HUMAN PRESCRIPTION DRUG sodium polystyrene sulfonate sodium polystyrene sulfonate POWDER ORAL 20091118 ANDA ANDA040905 Major Pharmaceuticals SODIUM POLYSTYRENE SULFONATE 1 g/g N 20181231 0904-6045_c432457b-9aaa-4fb0-9489-6c1e0804715c 0904-6045 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20141130 OTC MONOGRAPH FINAL part344 Major Pharmaceuticals ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 0904-6051_65a6b795-f38f-4a3c-84ba-446c79aad455 0904-6051 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20130802 ANDA ANDA078858 Major Pharmaceuticals LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 0904-6052_65a6b795-f38f-4a3c-84ba-446c79aad455 0904-6052 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090731 ANDA ANDA078858 Major Pharmaceuticals LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 0904-6053_65a6b795-f38f-4a3c-84ba-446c79aad455 0904-6053 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20130802 ANDA ANDA078858 Major Pharmaceuticals LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 0904-6061_dd6f3db2-1424-42b9-8ac5-e7fcf3089758 0904-6061 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20090809 ANDA ANDA075022 Major Pharmaceuticals BUSPIRONE HYDROCHLORIDE 15 mg/1 E 20171231 0904-6068_03983b59-0059-453a-bd84-9f6f102d8d63 0904-6068 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20090825 ANDA ANDA075604 Major Pharmaceuticals POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0904-6069_208389e6-ebbc-4e23-8312-e68bb6f697f0 0904-6069 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090810 ANDA ANDA075927 Major Pharmaceuticals NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-6073_3a88f295-bd1a-4252-9f9b-cff4c76e26cb 0904-6073 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090820 ANDA ANDA078705 Major Pharmaceuticals DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 0904-6074_15a8d9a9-ad90-462b-ad09-0e6336a342d1 0904-6074 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20100615 ANDA ANDA076134 Major Pharmaceuticals LORATADINE 10 mg/1 N 20181231 0904-6074_18ddf7c7-655e-46df-9d2f-400e453cb47a 0904-6074 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030828 ANDA ANDA076134 Major Pharmaceuticals LORATADINE 10 mg/1 N 20181231 0904-6078_1fe1f09c-85b9-491f-b3aa-78359448d004 0904-6078 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100510 ANDA ANDA078428 Major Pharmaceuticals GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 0904-6079_1fe1f09c-85b9-491f-b3aa-78359448d004 0904-6079 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100510 ANDA ANDA078428 Major Pharmaceuticals GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 0904-6080_e91ce413-8f8f-40a6-b78e-1c64b0c1bae4 0904-6080 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20100723 ANDA ANDA077824 Major Pharmaceuticals RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0904-6082_fe4aadd6-5f41-4501-b130-bc7be75e97c4 0904-6082 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Major Pharmaceuticals ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0904-6083_fe4aadd6-5f41-4501-b130-bc7be75e97c4 0904-6083 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Major Pharmaceuticals ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0904-6084_8937c071-6408-4a43-a887-eddf73b8aa04 0904-6084 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20091102 ANDA ANDA078216 Major Pharmaceuticals CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0904-6085_8937c071-6408-4a43-a887-eddf73b8aa04 0904-6085 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20091102 ANDA ANDA078216 Major Pharmaceuticals CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0904-6086_8937c071-6408-4a43-a887-eddf73b8aa04 0904-6086 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20091102 ANDA ANDA078216 Major Pharmaceuticals CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 0904-6087_01315e8f-278d-42cc-af60-b9bf55bc5713 0904-6087 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Tablets sertraline hydrochloride TABLET, FILM COATED ORAL 20091110 ANDA ANDA077397 Major Pharmaceuticals SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6088_01315e8f-278d-42cc-af60-b9bf55bc5713 0904-6088 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Tablets sertraline hydrochloride TABLET, FILM COATED ORAL 20091110 ANDA ANDA077397 Major Pharmaceuticals SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6089_01315e8f-278d-42cc-af60-b9bf55bc5713 0904-6089 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Tablets sertraline hydrochloride TABLET, FILM COATED ORAL 20091110 ANDA ANDA077397 Major Pharmaceuticals SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6090_a4300850-de1e-4e1c-bada-87ebe5ba2fe8 0904-6090 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100111 ANDA ANDA077880 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0904-6091_a4300850-de1e-4e1c-bada-87ebe5ba2fe8 0904-6091 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100111 ANDA ANDA077880 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0904-6092_a4300850-de1e-4e1c-bada-87ebe5ba2fe8 0904-6092 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100111 ANDA ANDA077880 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0904-6093_3c8682d6-b8f2-47b6-8fb1-22195e3323c9 0904-6093 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20100426 ANDA ANDA075584 Major Pharmaceuticals BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 0904-6096_f04109ce-7086-4026-9ce2-6912293925b8 0904-6096 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20100618 ANDA ANDA078251 Major Pharmaceuticals CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 0904-6097_f04109ce-7086-4026-9ce2-6912293925b8 0904-6097 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20100604 ANDA ANDA078251 Major Pharmaceuticals CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 0904-6098_f04109ce-7086-4026-9ce2-6912293925b8 0904-6098 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20100607 ANDA ANDA078251 Major Pharmaceuticals CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 0904-6099_f04109ce-7086-4026-9ce2-6912293925b8 0904-6099 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20100618 ANDA ANDA078251 Major Pharmaceuticals CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 0904-6100_f92d08e7-e530-4fbd-b196-287a9483467d 0904-6100 HUMAN OTC DRUG Cetirizine hydrochloride Cetirizine hydrochloride TABLET ORAL 20100625 ANDA ANDA077498 Major Pharmaceuticals CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 0904-6101_4dc1e02e-fa27-4fd7-97f8-58d1f78a10eb 0904-6101 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20100514 ANDA ANDA074979 Major Pharmaceuticals CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-6102_4dc1e02e-fa27-4fd7-97f8-58d1f78a10eb 0904-6102 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20100514 ANDA ANDA074979 Major Pharmaceuticals CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-6103_4dc1e02e-fa27-4fd7-97f8-58d1f78a10eb 0904-6103 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20100617 ANDA ANDA074979 Major Pharmaceuticals CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-6105_1fe1f09c-85b9-491f-b3aa-78359448d004 0904-6105 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100510 ANDA ANDA078428 Major Pharmaceuticals GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 0904-6117_e91ce413-8f8f-40a6-b78e-1c64b0c1bae4 0904-6117 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20100723 ANDA ANDA077824 Major Pharmaceuticals RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 0904-6119_8235cb6b-6696-4e8f-a195-e1cf39dbf3f7 0904-6119 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100301 ANDA ANDA076003 Major Pharmaceuticals TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 0904-6126_4c7a03f4-7f4e-49ca-92ea-da3921ccb569 0904-6126 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20091102 ANDA ANDA074823 Major Pharmaceuticals TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0904-6127_4c7a03f4-7f4e-49ca-92ea-da3921ccb569 0904-6127 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20091102 ANDA ANDA074823 Major Pharmaceuticals TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0904-6128_4c7a03f4-7f4e-49ca-92ea-da3921ccb569 0904-6128 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20091102 ANDA ANDA074823 Major Pharmaceuticals TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0904-6129_3c8682d6-b8f2-47b6-8fb1-22195e3323c9 0904-6129 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20100426 ANDA ANDA075584 Major Pharmaceuticals BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 0904-6136_f9aea785-f0a1-4716-8bb4-dfe4d9900f4e 0904-6136 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20030224 ANDA ANDA076243 Major Pharmaceuticals LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 0904-6140_9bbfe817-0d84-4926-8e76-1c67dc557682 0904-6140 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20100506 ANDA ANDA076161 Major Pharmaceuticals DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 0904-6141_9bbfe817-0d84-4926-8e76-1c67dc557682 0904-6141 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20100428 ANDA ANDA076161 Major Pharmaceuticals DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 0904-6142_9bbfe817-0d84-4926-8e76-1c67dc557682 0904-6142 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20100428 ANDA ANDA076161 Major Pharmaceuticals DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 0904-6143_9bbfe817-0d84-4926-8e76-1c67dc557682 0904-6143 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20100428 ANDA ANDA076161 Major Pharmaceuticals DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 0904-6144_aa78b362-b24f-4187-a8c1-37cd05f9b9c3 0904-6144 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20100716 ANDA ANDA076515 Major Pharmaceuticals OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 0904-6162_1c6741c5-84ec-4510-92a3-b0ed527a2e74 0904-6162 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100517 ANDA ANDA078459 Major Pharmaceuticals METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 0904-6169_be3256af-2378-4907-b218-c4fe1057a0a3 0904-6169 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101005 ANDA ANDA090615 Major Pharmaceuticals METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 0904-6170_be3256af-2378-4907-b218-c4fe1057a0a3 0904-6170 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101005 ANDA ANDA090615 Major Pharmaceuticals METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 0904-6171_be3256af-2378-4907-b218-c4fe1057a0a3 0904-6171 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101005 ANDA ANDA090615 Major Pharmaceuticals METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 0904-6172_d917d769-cd71-4b65-83c4-a1430aee2ce5 0904-6172 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20100920 ANDA ANDA077272 Major Pharmaceuticals CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 0904-6173_b24d3d60-0118-43f6-b428-76121b27de9a 0904-6173 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091201 ANDA ANDA075047 Major Pharmaceuticals ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0904-6174_54e05bc8-8609-4fb0-9a62-7dba80691b9a 0904-6174 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20101203 ANDA ANDA078477 Major Pharmaceuticals AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0904-6175_54e05bc8-8609-4fb0-9a62-7dba80691b9a 0904-6175 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20101203 ANDA ANDA078477 Major Pharmaceuticals AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0904-6176_0bd93751-f0f9-4871-9e43-19accbb5d74a 0904-6176 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 Major Pharmaceuticals BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0904-6177_0bd93751-f0f9-4871-9e43-19accbb5d74a 0904-6177 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 Major Pharmaceuticals BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0904-6178_0bd93751-f0f9-4871-9e43-19accbb5d74a 0904-6178 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 Major Pharmaceuticals BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 0904-6180_a48d51e5-9ace-485c-bcb9-a92cf09a4951 0904-6180 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline TABLET ORAL 20080227 ANDA ANDA065425 Major Pharmaceuticals DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 0904-6181_6cb34dc8-c9b6-4f4c-bd37-a88122990730 0904-6181 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET ORAL 20101119 ANDA ANDA065425 Major Pharmaceuticals DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0904-6183_79926161-4e38-4adc-9598-681ba1309568 0904-6183 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 19981125 ANDA ANDA075109 Major Pharmaceuticals GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0904-6184_79926161-4e38-4adc-9598-681ba1309568 0904-6184 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 19981125 ANDA ANDA075109 Major Pharmaceuticals GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0904-6185_2e56c449-21cf-47b1-8b7c-d561ddf86e49 0904-6185 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Major Pharmaceuticals NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-6186_2e56c449-21cf-47b1-8b7c-d561ddf86e49 0904-6186 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Major Pharmaceuticals NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-6187_e1a7ac45-56bb-4a25-9d84-af9e9af5a81d 0904-6187 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20091216 ANDA ANDA040765 Major Pharmaceuticals PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 0904-6188_54e05bc8-8609-4fb0-9a62-7dba80691b9a 0904-6188 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20101203 ANDA ANDA078477 Major Pharmaceuticals AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0904-6189_d243a93c-d2f3-426d-90f0-e30ff512a356 0904-6189 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Major Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0904-6190_d243a93c-d2f3-426d-90f0-e30ff512a356 0904-6190 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Major Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0904-6191_d243a93c-d2f3-426d-90f0-e30ff512a356 0904-6191 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Major Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0904-6192_d243a93c-d2f3-426d-90f0-e30ff512a356 0904-6192 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Major Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 0904-6193_eac173d6-c684-48e5-bc3b-b8badd965442 0904-6193 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20100716 ANDA ANDA076280 Major Pharmaceuticals TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 0904-6195_66105673-c65f-412c-9c1c-09580fc7b6b2 0904-6195 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100615 ANDA ANDA090568 Major Pharmaceuticals ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20191231 0904-6200_4cef3e31-982e-4f7c-8ade-0006a586d74e 0904-6200 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19930429 ANDA ANDA073582 Major Pharmaceutical ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 0904-6201_22ba7057-8d8a-45d3-8969-19908e78ebe4 0904-6201 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040765 Major Pharmaceuticals FOLIC ACID 1 mg/1 E 20171231 0904-6205_f9aea785-f0a1-4716-8bb4-dfe4d9900f4e 0904-6205 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20030224 ANDA ANDA076243 Major Pharmaceuticals LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] N 20181231 0904-6207_b6d13c1d-6e1b-4d12-be38-d7378eb4c73b 0904-6207 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20091224 ANDA ANDA040866 Major Pharmaceuticals PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0904-6214_c93a9479-02ba-4b5e-a013-9cc826dc3c3b 0904-6214 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Major Pharmaceuticals FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 0904-6216_5e221329-f318-4bca-a583-2d59e033d812 0904-6216 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20101130 ANDA ANDA072711 Major Pharmaceuticals SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-6217_5e221329-f318-4bca-a583-2d59e033d812 0904-6217 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20101130 ANDA ANDA072711 Major Pharmaceuticals SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-6221_968e568d-97dc-4f16-bacc-595887442280 0904-6221 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20110401 ANDA ANDA075517 Major Pharmaceuticals URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 0904-6232_9c563802-d9ca-4cc8-9df2-9712a409850b 0904-6232 HUMAN OTC DRUG MUCUS RELIEF GUAIFENESIN TABLET ORAL 20120723 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals GUAIFENESIN 400 mg/1 N 20181231 0904-6233_98770781-a4cb-48f7-ab08-1495f75c5acb 0904-6233 HUMAN OTC DRUG MUCUS RELIEF DM GUAIFENESIN, DEXTROMETHORPHAN HBr TABLET ORAL 20120723 OTC MONOGRAPH FINAL part341 MAJOR PHARMACEUTICALS INC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 0904-6234_cbc33bcc-7963-47c9-a772-d303fe771c41 0904-6234 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20110217 ANDA ANDA077421 Major Pharmaceuticals, Inc LORATADINE 5 mg/5mL E 20171231 0904-6235_a1488673-599d-4980-8816-8a53a2b41515 0904-6235 HUMAN PRESCRIPTION DRUG Pantoprazole Pantoprazole TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA077619 Major Pharmaceuticals PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 0904-6237_8a291e61-d23c-4afc-820c-bc0262b3061b 0904-6237 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110211 ANDA ANDA074260 Major Pharmaceuticals CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0904-6238_8a291e61-d23c-4afc-820c-bc0262b3061b 0904-6238 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110211 ANDA ANDA074260 Major Pharmaceuticals CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 0904-6245_89390611-265d-4f18-8b01-700e1bdc0788 0904-6245 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part333A Major Pharmaceuticals ISOPROPYL ALCOHOL 1.4 mL/1 N 20181231 0904-6246_7828978f-4109-4a7b-8199-98ed2017239d 0904-6246 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078865 Major Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6247_7828978f-4109-4a7b-8199-98ed2017239d 0904-6247 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078865 Major Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6248_7828978f-4109-4a7b-8199-98ed2017239d 0904-6248 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078865 Major Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6249_7854cf56-ffc0-4692-8c80-b966b49b7029 0904-6249 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110623 ANDA ANDA090367 Major Pharmaceuticals LEVOFLOXACIN 250 mg/1 N 20181231 0904-6250_7854cf56-ffc0-4692-8c80-b966b49b7029 0904-6250 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110623 ANDA ANDA090367 Major Pharmaceuticals LEVOFLOXACIN 500 mg/1 N 20181231 0904-6251_7854cf56-ffc0-4692-8c80-b966b49b7029 0904-6251 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110623 ANDA ANDA090367 Major Pharmaceuticals LEVOFLOXACIN 750 mg/1 N 20181231 0904-6252_031b5443-aae9-463f-9f63-8a8c9c6edb34 0904-6252 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110714 ANDA ANDA091179 Major Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0904-6254_8e20e385-99a1-4ead-8964-fa9fe18a0374 0904-6254 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Major Pharmaceuticals BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 0904-6255_c656fe47-8ea0-46a8-9e31-ff0a5719d28d 0904-6255 HUMAN OTC DRUG Sore Throat Logenzes Sore Throat Benzocaine and Menthol LOZENGE ORAL 20121228 OTC MONOGRAPH NOT FINAL part356 Major Pharmaceuticals BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 0904-6256_e9546f52-c2d3-4e9b-b716-c42195978f9b 0904-6256 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl LIQUID ORAL 20120314 ANDA ANDA091292 Major Pharmaceuticals LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 0904-6266_e487c98e-a33f-4ad1-be35-e121ed0d194d 0904-6266 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET, COATED ORAL 20111201 ANDA ANDA071586 Major Pharmaceuticals ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0904-6267_e487c98e-a33f-4ad1-be35-e121ed0d194d 0904-6267 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET, COATED ORAL 20111201 ANDA ANDA071587 Major Pharmaceuticals ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0904-6269_8bc8a69d-0441-46bf-b05e-32b92b9584ad 0904-6269 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Major Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6270_8bc8a69d-0441-46bf-b05e-32b92b9584ad 0904-6270 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Major Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6271_8bc8a69d-0441-46bf-b05e-32b92b9584ad 0904-6271 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Major Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6272_8bc8a69d-0441-46bf-b05e-32b92b9584ad 0904-6272 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Major Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6277_2358a9bc-5466-42fd-b00e-2d70e4566d37 0904-6277 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Major Pharmaceuticals QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6278_2358a9bc-5466-42fd-b00e-2d70e4566d37 0904-6278 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Major Pharmaceuticals QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6279_2358a9bc-5466-42fd-b00e-2d70e4566d37 0904-6279 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Major Pharmaceuticals QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6280_2358a9bc-5466-42fd-b00e-2d70e4566d37 0904-6280 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 20180630 ANDA ANDA077380 Major Pharmaceuticals QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6281_2358a9bc-5466-42fd-b00e-2d70e4566d37 0904-6281 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Major Pharmaceuticals QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6282_6ac27ac4-7056-469c-a5ee-046eddc79e54 0904-6282 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120329 ANDA ANDA202727 Major Pharmaceuticals LANSOPRAZOLE 15 mg/1 N 20181231 0904-6283_01785358-259f-4a34-a541-c10bd75b6eee 0904-6283 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Major Pharmaceuticals OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 0904-6283_5105c37a-3bb7-4831-b7bb-98e91b196059 0904-6283 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Major Pharmaceuticals OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 0904-6284_5105c37a-3bb7-4831-b7bb-98e91b196059 0904-6284 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Major Pharmaceuticals OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 0904-6285_5105c37a-3bb7-4831-b7bb-98e91b196059 0904-6285 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Major Pharmaceuticals OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 0904-6286_4530c210-e39b-41e9-b751-7edb9dd4eb8a 0904-6286 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076133 Major Pharmaceuticals OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6287_4530c210-e39b-41e9-b751-7edb9dd4eb8a 0904-6287 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076133 Major Pharmaceuticals OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6288_5cf8aaf6-ed79-48f5-9b05-cd2a3bda16d5 0904-6288 HUMAN OTC DRUG aspirin aspirin TABLET, CHEWABLE ORAL 20100716 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ASPIRIN 81 mg/1 N 20181231 0904-6289_5406ae9f-e1bf-4a65-bf8b-327e80c93dfd 0904-6289 HUMAN OTC DRUG Senna Sennosides A and B SYRUP ORAL 20120423 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals SENNOSIDES A AND B 8.8 mg/5mL E 20171231 0904-6290_69b13148-27f4-46fe-b6a3-8a668b059116 0904-6290 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Major Pharmaceuticals ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 0904-6291_69b13148-27f4-46fe-b6a3-8a668b059116 0904-6291 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Major Pharmaceuticals ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 0904-6292_b820f9d0-b8d6-42b2-b6f7-d78cc4a15d6c 0904-6292 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20141031 ANDA ANDA090548 Major Pharmaceuticals ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 0904-6293_b820f9d0-b8d6-42b2-b6f7-d78cc4a15d6c 0904-6293 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20141031 ANDA ANDA090548 Major Pharmaceuticals ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 0904-6294_725d2dd0-46a7-4d4e-8d94-d91c7c6d3316 0904-6294 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET ORAL 20120517 ANDA ANDA090844 Major Pharmaceuticals CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 0904-6295_c8280b83-ec9e-480a-99b4-53a84e931060 0904-6295 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110228 ANDA ANDA091416 Major Pharmaceuticals NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-6296_c8280b83-ec9e-480a-99b4-53a84e931060 0904-6296 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110228 ANDA ANDA091416 Major Pharmaceuticals NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-6297_c8280b83-ec9e-480a-99b4-53a84e931060 0904-6297 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110228 ANDA ANDA091416 Major Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 0904-6300_00caa63f-dd60-475c-ba6e-513d6e8440af 0904-6300 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20121114 ANDA ANDA078227 Major Pharmaceuticals CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 0904-6301_00caa63f-dd60-475c-ba6e-513d6e8440af 0904-6301 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20121114 ANDA ANDA078227 Major Pharmaceuticals CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 0904-6302_00caa63f-dd60-475c-ba6e-513d6e8440af 0904-6302 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20121114 ANDA ANDA078227 Major Pharmaceuticals CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 0904-6303_00caa63f-dd60-475c-ba6e-513d6e8440af 0904-6303 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20121114 ANDA ANDA078227 Major Pharmaceuticals CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 0904-6304_65c19f22-d0bb-4766-aa55-63a8afced2be 0904-6304 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20120827 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 0904-6305_5a4240a9-84f1-442d-b8ec-060a1678cd51 0904-6305 HUMAN OTC DRUG Sore Throat Cherry Phenol LIQUID ORAL 20120901 OTC MONOGRAPH NOT FINAL part356 Major Pharmaceuticals PHENOL 1.5 g/100mL N 20181231 0904-6306_40f1ea2a-208c-4e23-9e94-23a166eeb2f4 0904-6306 HUMAN OTC DRUG Robafen DM Cough Sugar Free Clear Guaifenesin and Dextromethorphan Hydrobromide SOLUTION ORAL 20121220 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 0904-6307_fa48e413-2429-4a66-8e7a-03e6facdccbd 0904-6307 HUMAN OTC DRUG Infants MAPAP Acetaminophen SUSPENSION ORAL 20120601 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 160 mg/5mL E 20171231 0904-6308_257c32d7-84d8-4727-8705-97bb1ba65a43 0904-6308 HUMAN OTC DRUG Childrens MAPAP Acetaminophen SUSPENSION ORAL 20150301 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 160 mg/5mL E 20171231 0904-6309_3f0ca421-52ee-4fd7-9a1b-284394476185 0904-6309 HUMAN OTC DRUG Robafen CF Cough and cold Guaifenesin, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride SOLUTION ORAL 20130305 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 100; 10; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 0904-6310_2fd38014-f01f-4385-8775-985cb1224bfe 0904-6310 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20120803 ANDA ANDA201515 Major Pharmaceuticals MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 0904-6311_596109bc-877d-4748-ac2d-1d554a3b8515 0904-6311 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET ORAL 20120904 ANDA ANDA079112 Major Pharmaceuticals FEXOFENADINE HYDROCHLORIDE 180 mg/1 E 20171231 0904-6312_2395661f-993d-444c-8a3e-89abe8fc301f 0904-6312 HUMAN OTC DRUG cough dm dextromethorphan polistirex SUSPENSION ORAL 20120906 ANDA ANDA091135 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 0904-6314_5cf8303e-7237-424f-973f-519e6681713a 0904-6314 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Major Pharmaceuticals ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6315_5cf8303e-7237-424f-973f-519e6681713a 0904-6315 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Major Pharmaceuticals ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6316_94d5036e-8f15-44f2-9820-a5eceb573e9b 0904-6316 HUMAN OTC DRUG Earwax Removal Aid CARBAMIDE PEROXIDE LIQUID AURICULAR (OTIC) 20110523 OTC MONOGRAPH FINAL part344 Major Pharmaceuticals CARBAMIDE PEROXIDE 65 mg/mL E 20171231 0904-6319_2ad9974c-efd5-476b-bc11-c978c3400ed4 0904-6319 HUMAN OTC DRUG Major Prep Hemorrhoidal Mineral Oil, Petrolatum, Phenylephrine Hydrochloride OINTMENT RECTAL; TOPICAL 20130630 OTC MONOGRAPH FINAL part346 Major Pharmaceuticals MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/g; mg/g; mg/g E 20171231 0904-6320_ebbf25fb-dd7f-4155-a04b-feb4ccfb8d0e 0904-6320 HUMAN OTC DRUG Saline Laxative Saline Laxative ENEMA RECTAL 20130711 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/133mL; g/133mL N 20181231 0904-6322_7a108a92-0510-48e3-bc8c-efd5a3b4ae60 0904-6322 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Major Pharmaceuticals METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0904-6323_7a108a92-0510-48e3-bc8c-efd5a3b4ae60 0904-6323 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Major Pharmaceuticals METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0904-6324_261424c1-6c59-4f07-bbc5-f3e63d5541d3 0904-6324 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 Major Pharmaceuticals METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0904-6326_748a6574-4f0f-48c5-bd90-68f5930356ca 0904-6326 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0904-6327_748a6574-4f0f-48c5-bd90-68f5930356ca 0904-6327 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0904-6328_748a6574-4f0f-48c5-bd90-68f5930356ca 0904-6328 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0904-6329_65c35a85-4732-4669-8ede-ed8c0610b846 0904-6329 HUMAN OTC DRUG lubricating plus carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20130509 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM .5 g/100mL N 20181231 0904-6331_6c120728-527e-4e79-9951-5af61f9e3480 0904-6331 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130515 ANDA ANDA077397 Major Pharmaceuticals SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6332_6c120728-527e-4e79-9951-5af61f9e3480 0904-6332 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130515 ANDA ANDA077397 Major Pharmaceuticals SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6333_6c120728-527e-4e79-9951-5af61f9e3480 0904-6333 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130515 ANDA ANDA077397 Major Pharmaceuticals SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6334_c91bada6-602e-4407-9fb7-b32734e9996e 0904-6334 HUMAN OTC DRUG Major Redness Reliever Eye Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mg N 20181231 0904-6337_828e5b5f-9e1d-4c68-bb6a-64793a6c8459 0904-6337 HUMAN OTC DRUG SudoGest Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19910910 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 0904-6338_bb1c802a-496a-4de6-a8fa-ff0fb4f09255 0904-6338 HUMAN OTC DRUG SudoGest PSEUDOEPHEDRINE HCL TABLET, COATED ORAL 20140217 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 0904-6339_9a880e33-65ac-4bd3-8189-c68b67526b38 0904-6339 HUMAN OTC DRUG Senna Plus standardized senna concentrate and docusate sodium TABLET ORAL 20100114 UNAPPROVED DRUG OTHER Major Pharmaceuticals SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 E 20171231 0904-6340_b9a593db-edab-4c5c-ac3b-8d471fc99175 0904-6340 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20140314 ANDA ANDA202871 Major Pharmaceuticals METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0904-6341_b9a593db-edab-4c5c-ac3b-8d471fc99175 0904-6341 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20140314 ANDA ANDA202871 Major Pharmaceuticals METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0904-6342_b9a593db-edab-4c5c-ac3b-8d471fc99175 0904-6342 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20140314 ANDA ANDA202871 Major Pharmaceuticals METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0904-6343_3aafbfb9-9b08-448f-a611-a67af13f1388 0904-6343 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20140203 ANDA ANDA075965 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0904-6344_3aafbfb9-9b08-448f-a611-a67af13f1388 0904-6344 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20140203 ANDA ANDA075965 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0904-6345_3aafbfb9-9b08-448f-a611-a67af13f1388 0904-6345 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20140203 ANDA ANDA075965 Major Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 0904-6346_d13bb64e-c8db-43d9-b7d7-7b2197eb6d87 0904-6346 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880107 ANDA ANDA086223 Major Pharmaceuticals ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 0904-6347_d13bb64e-c8db-43d9-b7d7-7b2197eb6d87 0904-6347 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880407 ANDA ANDA089367 Major Pharmaceuticals ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 0904-6348_0c34860a-cff1-49a2-b4eb-68fc76a6c309 0904-6348 HUMAN OTC DRUG Body Menthol POWDER TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals MENTHOL 1.5 mg/g N 20181231 0904-6349_9ebd3eac-89f9-4868-8130-88d82f1af3d8 0904-6349 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20131001 ANDA ANDA201745 Major Pharmaceuticals RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 0904-6350_9ebbf8cc-e795-42a8-a210-de72db118f05 0904-6350 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20131001 ANDA ANDA200536 Major Pharmaceuticals RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 0904-6351_a79a62f8-e966-4427-be52-23f7c8ffdcb6 0904-6351 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131201 ANDA ANDA076710 Major Pharmaceuticals LEVOFLOXACIN 250 mg/1 N 20181231 0904-6352_a79a62f8-e966-4427-be52-23f7c8ffdcb6 0904-6352 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131201 ANDA ANDA076710 Major Pharmaceuticals LEVOFLOXACIN 500 mg/1 N 20181231 0904-6353_a79a62f8-e966-4427-be52-23f7c8ffdcb6 0904-6353 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131201 ANDA ANDA076710 Major Pharmaceuticals LEVOFLOXACIN 750 mg/1 N 20181231 0904-6354_6151d334-68c8-4b69-ab71-9dba58d10a11 0904-6354 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 Major Pharmaceuticals DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 0904-6355_6151d334-68c8-4b69-ab71-9dba58d10a11 0904-6355 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 Major Pharmaceuticals DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 0904-6356_daf43ce5-e0d1-4309-8490-fe08bf628c77 0904-6356 HUMAN OTC DRUG Major Prep Hemorrhoidal Mineral Oil, Petrolatum, Phenylephrine Hydrochloride OINTMENT RECTAL; TOPICAL 20140603 OTC MONOGRAPH FINAL part346 Major Pharmaceuticals MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/g; mg/g; mg/g N 20181231 0904-6357_9097e76f-0263-4037-b514-d222dbc487a2 0904-6357 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Major Pharmaceuticals RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20191231 0904-6358_9097e76f-0263-4037-b514-d222dbc487a2 0904-6358 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Major Pharmaceuticals RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20191231 0904-6359_9097e76f-0263-4037-b514-d222dbc487a2 0904-6359 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Major Pharmaceuticals RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20191231 0904-6360_9097e76f-0263-4037-b514-d222dbc487a2 0904-6360 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Major Pharmaceuticals RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20191231 0904-6361_9097e76f-0263-4037-b514-d222dbc487a2 0904-6361 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Major Pharmaceuticals RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20191231 0904-6362_9097e76f-0263-4037-b514-d222dbc487a2 0904-6362 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Major Pharmaceuticals RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20191231 0904-6363_2e3c6e7d-ccea-4e31-998c-909b870d4392 0904-6363 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130811 ANDA ANDA090161 Major Pharmaceuticals DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0904-6364_a9aeb198-1467-4335-989d-998a7a923951 0904-6364 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130811 ANDA ANDA090070 Major Pharmaceuticals DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 0904-6365_63c68f1f-fab6-4f32-badd-869507e5573f 0904-6365 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20140226 ANDA ANDA090404 Major Pharmaceuticals TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 0904-6366_de4a95bb-f756-4fce-a7de-bec264c8a15d 0904-6366 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Major Pharmaceuticals DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6367_de4a95bb-f756-4fce-a7de-bec264c8a15d 0904-6367 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Major Pharmaceuticals DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6368_de4a95bb-f756-4fce-a7de-bec264c8a15d 0904-6368 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Major Pharmaceuticals DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6369_7626aeb8-de80-490b-aafe-559cebbfa486 0904-6369 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130120 ANDA ANDA078226 Major Pharmaceuticals AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 0904-6370_7626aeb8-de80-490b-aafe-559cebbfa486 0904-6370 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130120 ANDA ANDA078226 Major Pharmaceuticals AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 0904-6371_7626aeb8-de80-490b-aafe-559cebbfa486 0904-6371 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130120 ANDA ANDA078226 Major Pharmaceuticals AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 0904-6372_ce432dd3-5c69-41ad-b40d-0dbf90e6abec 0904-6372 HUMAN OTC DRUG Cetrizine Hydrochloride CETIRIZINE HYDROCHLORIDE SOLUTION ORAL 20140224 ANDA ANDA090474 Major Pharmaceuticals CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 0904-6373_b5b704e8-aea3-47fb-8fd0-bb78cb1273a3 0904-6373 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141001 ANDA ANDA090429 Major Pharmaceuticals ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0904-6374_b5b704e8-aea3-47fb-8fd0-bb78cb1273a3 0904-6374 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141001 ANDA ANDA090429 Major Pharmaceuticals ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 0904-6375_bc099f91-611c-49e2-adab-011ac5062b23 0904-6375 HUMAN PRESCRIPTION DRUG Rabeprazole sodium Rabeprazole sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA202376 Major Pharmaceuticals RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 0904-6376_01785358-259f-4a34-a541-c10bd75b6eee 0904-6376 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Major Pharmaceuticals OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 0904-6377_01785358-259f-4a34-a541-c10bd75b6eee 0904-6377 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Major Pharmaceuticals OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 0904-6378_c98c3633-be15-47c7-a5eb-4c11ecf0b530 0904-6378 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20140609 ANDA ANDA075593 Major Pharmaceuticals CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 0904-6389_2873e899-f729-437e-818f-9063202e3f6a 0904-6389 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Major Pharmaceuticals LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 0904-6390_2873e899-f729-437e-818f-9063202e3f6a 0904-6390 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Major Pharmaceuticals LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 0904-6391_2873e899-f729-437e-818f-9063202e3f6a 0904-6391 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Major Pharmaceuticals LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 0904-6398_2aa512e7-4833-4c09-b616-229559975828 0904-6398 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20140616 ANDA ANDA077380 Major Pharmaceuticals QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6401_a4626492-035e-4b15-9c29-c809da7c19c2 0904-6401 HUMAN PRESCRIPTION DRUG tamsulosin hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20150105 ANDA ANDA078015 Major Pharmaceuticals TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 0904-6405_c48c1b4b-62c1-4429-89a2-5d97036ade65 0904-6405 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110718 ANDA ANDA065507 Major Pharmaceuticals AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 0904-6406_5d8ef130-27b1-4151-8f5d-598e606afbab 0904-6406 HUMAN PRESCRIPTION DRUG Moxifloxacin Moxifloxacin TABLET, FILM COATED ORAL 20140305 ANDA ANDA076938 Major Pharmaceuticals MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 0904-6407_b25d728e-1d68-465c-8a69-01a0df1946c7 0904-6407 HUMAN OTC DRUG Unit Dose Bisacodyl Bisacodyl TABLET, COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals BISACODYL 5 mg/1 N 20181231 0904-6408_86a17f3c-5e3d-42ed-8d8c-dc07e5ee2695 0904-6408 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20160129 ANDA ANDA201724 Major Pharmaceuticals DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0904-6409_86a17f3c-5e3d-42ed-8d8c-dc07e5ee2695 0904-6409 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20160129 ANDA ANDA201724 Major Pharmaceuticals DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0904-6410_466b3f8c-37d6-45a3-ab59-96d2229e4ef9 0904-6410 HUMAN PRESCRIPTION DRUG Dehydrated Alcohol Dehydrated alcohol INJECTION INTRASPINAL 20140801 UNAPPROVED DRUG OTHER Major Pharmaceuticals ALCOHOL .98 mL/mL E 20171231 0904-6412_2ba0eeb2-7048-4259-83d5-9f4ec1c92d32 0904-6412 HUMAN OTC DRUG Major Regular Strength Assorted Flavors Antacid Tablets TABLET, CHEWABLE ORAL 20140812 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals CALCIUM CARBONATE 500 mg/1 N 20181231 0904-6413_27532e49-4226-414c-86be-ae66d3a19cde 0904-6413 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20150325 ANDA ANDA071210 Major Pharmaceuticals HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] E 20171231 0904-6418_81aa5d00-ff61-4dd5-b6e4-ccd093f35d3c 0904-6418 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20141001 ANDA ANDA076533 Major Pharmaceuticals TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 0904-6419_0720c952-aba8-4c71-90ee-d0081cabeae6 0904-6419 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen Hydrocodone Bitartate and Acetaminophen TABLET ORAL 20150205 ANDA ANDA040099 Major Pharmaceuticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 0904-6420_5c77d15c-40e8-41d7-9d57-7c9b553b6c0b 0904-6420 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130314 ANDA ANDA040148 Major Pharmaceuticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 0904-6421_5c77d15c-40e8-41d7-9d57-7c9b553b6c0b 0904-6421 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130307 ANDA ANDA040148 Major Pharmaceuticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 0904-6422_533dc195-559d-44eb-993c-bbbe183b5b7b 0904-6422 HUMAN OTC DRUG PEG 3350 POLYETHYLENE GLYCOL 3350 POWDER ORAL 20150304 ANDA ANDA091077 Major Pharmaceuticals POLYETHYLENE GLYCOL 3350 17 g/17g E 20171231 0904-6423_cebdc039-c233-46b7-984a-fe9cf4dba092 0904-6423 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130403 ANDA ANDA076715 Major Pharmaceuticals MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 0904-6424_cebdc039-c233-46b7-984a-fe9cf4dba092 0904-6424 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130403 ANDA ANDA076715 Major Pharmaceuticals MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 0904-6425_75d85599-3344-4c27-b395-7e0fdd3e993d 0904-6425 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20150105 ANDA ANDA091195 Major Pharmaceuticals TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0904-6426_5e63fbb1-f709-47ed-bd66-a018fec021f6 0904-6426 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20141015 ANDA ANDA090939 Major Pharmaceuticals ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6427_5e63fbb1-f709-47ed-bd66-a018fec021f6 0904-6427 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20141015 ANDA ANDA090939 Major Pharmaceuticals ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 0904-6434_0c7d896f-a9c8-40f9-ac8a-db3fe55ccd1e 0904-6434 HUMAN OTC DRUG SENNA SENNA TABLET, COATED ORAL 20150609 OTC MONOGRAPH NOT FINAL part334 MAJOR PHARMACEUTICALS SENNOSIDES A AND B 8.6 mg/1 N 20181231 0904-6436_1a909bfb-f125-46a0-813d-535c983278d1 0904-6436 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20150325 ANDA ANDA071457 Major Pharmaceuticals TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 0904-6437_c78371fe-2555-4ef4-82d3-578b5da23aa3 0904-6437 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20150325 ANDA ANDA040105 Major Pharmaceuticals OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0904-6438_9ee3d821-0bec-43bb-9723-3437e070d60f 0904-6438 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20150325 ANDA ANDA090734 Major Pharmaceuticals OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0904-6439_9ee3d821-0bec-43bb-9723-3437e070d60f 0904-6439 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20150325 ANDA ANDA090734 Major Pharmaceuticals OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0904-6440_31100717-d692-4ce7-b364-95b85018fbc9 0904-6440 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20150514 ANDA ANDA086242 Major Pharmaceuticals HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 0904-6441_31100717-d692-4ce7-b364-95b85018fbc9 0904-6441 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20150514 ANDA ANDA086242 Major Pharmaceuticals HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 0904-6442_31100717-d692-4ce7-b364-95b85018fbc9 0904-6442 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20150514 ANDA ANDA086242 Major Pharmaceuticals HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 0904-6443_31100717-d692-4ce7-b364-95b85018fbc9 0904-6443 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20150514 ANDA ANDA086242 Major Pharmaceuticals HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 0904-6444_d33cb8a0-3f5b-42d6-8985-79d5a1a1f798 0904-6444 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20150205 ANDA ANDA077290 Major Pharmaceuticals OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0904-6445_8f1ac509-0c25-41e6-82cc-b4854656e5e4 0904-6445 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20150601 ANDA ANDA077290 Major Pharmaceuticals OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 0904-6449_476da661-b1f6-4f61-876e-b829cfbc50fc 0904-6449 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20150105 ANDA ANDA200270 Major Pharmaceuticals ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 0904-6450_476da661-b1f6-4f61-876e-b829cfbc50fc 0904-6450 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20150105 ANDA ANDA200495 Major Pharmaceuticals ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 0904-6451_476da661-b1f6-4f61-876e-b829cfbc50fc 0904-6451 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20150105 ANDA ANDA200495 Major Pharmaceuticals ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 0904-6452_fa1c61e3-bbfb-402b-8dc9-beaf88abecde 0904-6452 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Major Pharmaceuticals DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0904-6453_fa1c61e3-bbfb-402b-8dc9-beaf88abecde 0904-6453 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Major Pharmaceuticals DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0904-6454_fa1c61e3-bbfb-402b-8dc9-beaf88abecde 0904-6454 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Major Pharmaceuticals DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0904-6455_674181a6-05b4-463c-98d5-cccea6a113e2 0904-6455 HUMAN OTC DRUG DOK Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM 100 mg/1 N 20181231 0904-6456_5a2c307d-04b2-46a5-ac58-c6f901f2a5e8 0904-6456 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20150215 ANDA ANDA065138 Major Pharmaceuticals NYSTATIN 100000 U/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 0904-6457_12b0f8c7-d195-4853-a3fb-c34dfd8db74b 0904-6457 HUMAN OTC DRUG DOK DOCUSATE SODIUM CAPSULE ORAL 20150228 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM 100 mg/1 N 20181231 0904-6458_f1bd5e14-e629-4399-b5d3-63727c408d25 0904-6458 HUMAN OTC DRUG DOK DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM 250 mg/1 N 20181231 0904-6459_a5127681-3c29-4756-b673-b35a23510a10 0904-6459 HUMAN OTC DRUG Kao Tin Docusate calcium CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE CALCIUM 240 mg/1 N 20181231 0904-6460_21a6b63b-6040-4b0c-9487-ef3863b63e00 0904-6460 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH FINAL part347 Major Pharmaceuticals DIMETHICONE 125 mg/1 N 20181231 0904-6461_2c7c909f-efc0-46fa-9981-1446a0dc42c6 0904-6461 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20150315 ANDA ANDA084176 Major Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 0904-6462_d88c967e-9655-436c-a6fd-c20dbf9e8ac6 0904-6462 HUMAN OTC DRUG dimaphen phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20060911 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 0904-6463_178da05d-549e-4203-b6e6-4a539986cdfc 0904-6463 HUMAN OTC DRUG dimaphen dm Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20060911 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 0904-6464_aae6280b-5f85-4ec3-ae01-84c9877d35b7 0904-6464 HUMAN OTC DRUG robafen Dextromethorphan HBr, Guaifenesin SYRUP ORAL 19910315 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 0904-6465_e7eab851-0431-48b2-92a2-71e5f46dd4e4 0904-6465 HUMAN OTC DRUG all nite Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20121119 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 0904-6467_e6e53076-2d34-4792-8597-ef3de97bc95b 0904-6467 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel bisulfate TABLET, FILM COATED ORAL 20150406 ANDA ANDA076274 Major Pharmaceuticals CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20191231 0904-6468_0f608fa5-9dbc-465e-bc3d-aa9b21257331 0904-6468 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150406 ANDA ANDA090899 Major Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0904-6469_0f608fa5-9dbc-465e-bc3d-aa9b21257331 0904-6469 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150406 ANDA ANDA090899 Major Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0904-6470_0f608fa5-9dbc-465e-bc3d-aa9b21257331 0904-6470 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150406 ANDA ANDA090899 Major Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 0904-6471_be5e33f6-b6d2-4661-9bcf-e20a472b5a5f 0904-6471 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20150325 ANDA ANDA200265 Major Pharmaceuticals VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 0904-6474_dd3499fb-9dc3-4ef5-a445-56b408f0b162 0904-6474 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20150601 ANDA ANDA090074 Major Pharmaceuticals PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 0904-6475_4e09f593-bf6a-4737-b104-6d13abd56e98 0904-6475 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20150715 ANDA ANDA078220 Major Pharmaceuticals BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 0904-6476_4e09f593-bf6a-4737-b104-6d13abd56e98 0904-6476 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20150715 ANDA ANDA077241 Major Pharmaceuticals BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 0904-6477_c777ddc9-0b61-4d6f-95d6-818ba1861d62 0904-6477 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Major Pharmaceuticals DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20191231 0904-6478_c777ddc9-0b61-4d6f-95d6-818ba1861d62 0904-6478 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Major Pharmaceuticals DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20191231 0904-6479_a807e19e-0d41-4ef2-9c7a-2c6327ca469f 0904-6479 HUMAN OTC DRUG Robafen AC Guaifenesin and Codeine Phosphate SYRUP ORAL 20171214 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals GUAIFENESIN; CODEINE PHOSPHATE 100; 10 mg/5mL; mg/5mL CV N 20191231 0904-6483_e2f94356-58b3-477c-bfc5-a0d9a01d9499 0904-6483 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20090101 ANDA ANDA079082 Major Pharmaceuticals URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] E 20171231 0904-6484_eb2f0c87-1529-4ba6-82ff-14b615cc373b 0904-6484 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150615 ANDA ANDA075994 Major Pharmaceuticals LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0904-6485_eb2f0c87-1529-4ba6-82ff-14b615cc373b 0904-6485 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150615 ANDA ANDA075994 Major Pharmaceuticals LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0904-6486_eb2f0c87-1529-4ba6-82ff-14b615cc373b 0904-6486 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150615 ANDA ANDA075994 Major Pharmaceuticals LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0904-6487_eb2f0c87-1529-4ba6-82ff-14b615cc373b 0904-6487 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150615 ANDA ANDA075994 Major Pharmaceuticals LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 0904-6488_f82a43f5-bde0-41e3-8669-f2fd74244663 0904-6488 HUMAN OTC DRUG Major LubriFresh PM Mineral oil and White petrolatum OINTMENT OPHTHALMIC 20150911 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g N 20181231 0904-6489_d8db73cb-55a1-4b4d-8c70-17fc388df779 0904-6489 HUMAN OTC DRUG Major Hypertonicity Ophthalmic Sodium chloride OINTMENT OPHTHALMIC 20150914 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals SODIUM CHLORIDE 50 mg/g N 20181231 0904-6490_5559acf5-7cdc-4895-97c4-ae72f42c0074 0904-6490 HUMAN OTC DRUG Major Hypertonicity Sodium chloride SOLUTION/ DROPS OPHTHALMIC 20150917 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals SODIUM CHLORIDE 50 mg/mL N 20181231 0904-6491_795f138e-7f7c-489f-b64c-2899a82aa9d2 0904-6491 HUMAN OTC DRUG Major Eye Wash Purified water SOLUTION OPHTHALMIC 20150917 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals WATER 99.05 mL/100mL E 20171231 0904-6492_5138c46b-b70c-4605-8521-3f5b2149458f 0904-6492 HUMAN OTC DRUG Major LiquiTears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20150917 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals POLYVINYL ALCOHOL 14 mg/mL N 20181231 0904-6493_6237a285-b290-4365-a60c-5db731cb10f1 0904-6493 HUMAN OTC DRUG Major Natural Balance Dextran 70, and Hypromellose 2910 SOLUTION/ DROPS OPHTHALMIC 20150917 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) 1; 3 mg/mL; mg/mL N 20181231 0904-6500_ee690b2b-e5cf-4ad5-ac89-504311eacb9c 0904-6500 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20150625 ANDA ANDA076658 Major Pharmaceuticals FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0904-6501_ee690b2b-e5cf-4ad5-ac89-504311eacb9c 0904-6501 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20150625 ANDA ANDA076658 Major Pharmaceuticals FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0904-6502_a683f3fc-6401-47c0-9643-db76aef4d48b 0904-6502 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150625 ANDA ANDA204197 Major Pharmaceuticals CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 0904-6503_a683f3fc-6401-47c0-9643-db76aef4d48b 0904-6503 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150625 ANDA ANDA204197 Major Pharmaceuticals CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 0904-6505_6a6fe913-31da-400d-a7d8-f701e580ae62 0904-6505 HUMAN PRESCRIPTION DRUG Memantine Memantine TABLET ORAL 20150720 ANDA ANDA090048 Major Pharmaceuticals MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0904-6506_6a6fe913-31da-400d-a7d8-f701e580ae62 0904-6506 HUMAN PRESCRIPTION DRUG Memantine Memantine TABLET ORAL 20150720 ANDA ANDA090048 Major Pharmaceuticals MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 0904-6507_084de6dc-7339-48de-a2fd-a14410026483 0904-6507 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140116 NDA AUTHORIZED GENERIC NDA018279 Major Pharmaceuticals POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 0904-6508_cbcf32dd-e40d-4340-8e28-67d947dd3b33 0904-6508 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 19951130 ANDA ANDA040104 Major Pharmaceuticals HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20191231 0904-6509_7c5644e4-4a56-4cfb-85b8-7715cfee6d6b 0904-6509 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150825 ANDA ANDA078583 Major Pharmaceuticals ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20191231 0904-6510_7c5644e4-4a56-4cfb-85b8-7715cfee6d6b 0904-6510 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150825 ANDA ANDA078583 Major Pharmaceuticals ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20191231 0904-6511_7c5644e4-4a56-4cfb-85b8-7715cfee6d6b 0904-6511 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150825 ANDA ANDA078583 Major Pharmaceuticals ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20191231 0904-6512_7c5644e4-4a56-4cfb-85b8-7715cfee6d6b 0904-6512 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150825 ANDA ANDA078583 Major Pharmaceuticals ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20191231 0904-6513_7c5644e4-4a56-4cfb-85b8-7715cfee6d6b 0904-6513 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150825 ANDA ANDA078583 Major Pharmaceuticals ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20191231 0904-6514_7c5644e4-4a56-4cfb-85b8-7715cfee6d6b 0904-6514 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150825 ANDA ANDA078583 Major Pharmaceuticals ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20191231 0904-6516_2dba8d25-02d3-4ea0-9861-f65b9d3168bb 0904-6516 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20100212 ANDA ANDA201451 Major Pharmaceuticals MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 0904-6517_2dba8d25-02d3-4ea0-9861-f65b9d3168bb 0904-6517 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20100212 ANDA ANDA201451 Major Pharmaceuticals MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 0904-6519_1b299adf-51a9-4bf5-95f0-2c0a017dd031 0904-6519 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Major Pharmaceuticals MIRTAZAPINE 15 mg/1 N 20181231 0904-6521_b7ad3b08-48a4-486a-a2d7-960104d6af34 0904-6521 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20160318 ANDA ANDA090195 Major Pharmaceuticals GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0904-6522_60df6b3a-c9ff-4ddd-e053-2991aa0a40fd 0904-6522 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 20010124 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals SENNOSIDES A AND B 8.6 mg/1 N 20181231 0904-6523_1c588af2-3239-4c81-9337-0c3ba5d261f0 0904-6523 HUMAN PRESCRIPTION DRUG Abacavir Sulfate Abacavir Sulfate TABLET, FILM COATED ORAL 20121217 ANDA ANDA201570 Major Pharmaceuticals ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 0904-6529_bc19872b-109d-4f0d-a363-36f9a82e1eca 0904-6529 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA091576 Major Pharmaceuticals MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 0904-6530_df394ea1-003f-4fb3-b59d-f51c5937d004 0904-6530 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20120116 ANDA ANDA090635 Major Pharmaceuticals METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 0904-6536_567bc05c-e609-40aa-a302-75d9a0a63106 0904-6536 HUMAN OTC DRUG Mapap Childrens Acetaminophen SUSPENSION ORAL 20151031 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 160 mg/5mL N 20181231 0904-6537_7e818e44-1100-4b68-b6ea-29670e28bddf 0904-6537 HUMAN OTC DRUG Tussin Multi Symptom Cold CF Adult Dextromethorphan HBr, Guaifenesin, Phenylephrine LIQUID ORAL 20151130 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 0904-6538_0745ddc6-93a5-40a1-aea4-dd93fec49a50 0904-6538 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 Major Pharmaceuticals BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 0904-6539_fbf677fa-206a-471f-b4e8-93dc3b9bd4ae 0904-6539 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040738 Major Pharmaceuticals BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0904-6540_fbf677fa-206a-471f-b4e8-93dc3b9bd4ae 0904-6540 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040742 Major Pharmaceuticals BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0904-6541_fbf677fa-206a-471f-b4e8-93dc3b9bd4ae 0904-6541 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040715 Major Pharmaceuticals BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 0904-6544_ee37b27f-0477-4fe1-bd82-4bd4cafbbaf6 0904-6544 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20070622 ANDA ANDA077899 Major Pharmaceuticals NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0904-6545_ee37b27f-0477-4fe1-bd82-4bd4cafbbaf6 0904-6545 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20070622 ANDA ANDA077899 Major Pharmaceuticals NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 0904-6546_9d9a4fe4-a745-4aa6-8ae0-c51454340a88 0904-6546 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20141008 ANDA ANDA201658 Major Pharmaceuticals CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 0904-6550_4623f12b-406a-4971-b48f-cce67ea07b9d 0904-6550 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070217 Major Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 0904-6551_a9ee55d1-922c-464f-a9b5-733aac1aabb2 0904-6551 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20061226 ANDA ANDA076183 Major Pharmaceuticals ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 0904-6552_a9ee55d1-922c-464f-a9b5-733aac1aabb2 0904-6552 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20061226 ANDA ANDA076183 Major Pharmaceuticals ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 0904-6553_bef116a8-427d-4855-86de-0017e01430b0 0904-6553 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20151221 ANDA ANDA205517 Major Pharmaceuticals LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] E 20171231 0904-6554_3fc6bfae-9f56-43b4-8d71-cc42cfdc166a 0904-6554 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071258 Major Pharmaceuticals TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 0904-6555_3fc6bfae-9f56-43b4-8d71-cc42cfdc166a 0904-6555 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Major Pharmaceuticals TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 0904-6556_a28206ce-d91e-4bb6-9b07-2188059f9d26 0904-6556 HUMAN PRESCRIPTION DRUG Amiodarone hydrochloride Amiodarone hydrochloride TABLET ORAL 20090810 ANDA ANDA079029 Major Pharmaceuticals AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 0904-6557_dbb37dfd-0196-45f7-b9ca-393f56cf1d28 0904-6557 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Major Pharmaceuticals MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0904-6558_dbb37dfd-0196-45f7-b9ca-393f56cf1d28 0904-6558 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Major Pharmaceuticals MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0904-6559_dbb37dfd-0196-45f7-b9ca-393f56cf1d28 0904-6559 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Major Pharmaceuticals MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0904-6560_dbb37dfd-0196-45f7-b9ca-393f56cf1d28 0904-6560 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074769 Major Pharmaceuticals MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0904-6564_1b94f975-2b82-473b-be98-02996139c524 0904-6564 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070904 ANDA ANDA040597 Major Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 0904-6565_058cbd0a-d994-4fda-811b-b211eab469a0 0904-6565 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Major Pharmaceuticals VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 0904-6566_e9718369-9fb6-4ac2-8fc3-7902845a6b69 0904-6566 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE, LIQUID FILLED ORAL 20150101 ANDA ANDA090103 Major Pharmaceuticals NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 0904-6567_a44dd7e2-401b-4f4b-9be9-d3693bb6d263 0904-6567 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160526 ANDA ANDA040148 Major Pharmaceuticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 0904-6568_5d8de1a5-9b14-401d-a134-d04cba21d383 0904-6568 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20141124 ANDA ANDA070044 Major Pharmaceuticals METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20191231 0904-6570_b3c4f54b-8e61-45d4-aaf1-7e8eb4085bd1 0904-6570 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20151102 ANDA ANDA204010 Major Pharmaceuticals OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0904-6571_c5d51b35-1eea-40de-8a3e-6ac6cf245c53 0904-6571 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Major Pharamceuticals ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0904-6572_c5d51b35-1eea-40de-8a3e-6ac6cf245c53 0904-6572 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Major Pharamceuticals ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 0904-6573_0f97dd02-bee7-4fa9-89de-b0817fbc8167 0904-6573 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 Major Pharmaceuticals BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0904-6574_4ce349cb-a6d1-4d6c-a1e9-4d6fdaadcadd 0904-6574 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 19981222 ANDA ANDA040183 Major Pharmaceuticals METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 0904-6575_b809563f-da45-41a6-91ae-5e3a925ed441 0904-6575 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20030201 UNAPPROVED DRUG OTHER Major Pharmaceuticals PHENOBARBITAL 32.4 mg/1 CIV N 20181231 0904-6580_efe891ab-d211-4d46-900a-109550bd9925 0904-6580 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20151210 ANDA ANDA078279 Major Pharmaceuticals ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0904-6581_efe891ab-d211-4d46-900a-109550bd9925 0904-6581 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20151210 ANDA ANDA078279 Major Pharmaceuticals ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 0904-6582_f15af180-8b03-4512-b1b7-e03273c00d32 0904-6582 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100604 ANDA ANDA040756 Major Pharmaceuticals FOLIC ACID 1 mg/1 N 20181231 0904-6583_6fd4d6b9-65ea-4988-8d6f-dd220ec5052d 0904-6583 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20111202 ANDA ANDA091606 Major Pharmaceuticals LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 0904-6585_65f1fb11-bf77-4eb3-aa7d-b2800fcac35f 0904-6585 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040322 ANDA ANDA075932 Major Pharmaceuticals BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 0904-6586_ddbaa9ed-f4d9-4451-9ca8-9e755a58dd78 0904-6586 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20040214 ANDA ANDA075694 Major Pharmaceuticals GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 0904-6587_235ed234-6f38-4825-bcea-94914bbd7486 0904-6587 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077129 Major Pharmaceuticals RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0904-6590_c40e1ec4-5dd1-4d9d-b051-3bb96b72fff3 0904-6590 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20150413 ANDA ANDA077712 Major Pharmaceuticals OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0904-6591_c40e1ec4-5dd1-4d9d-b051-3bb96b72fff3 0904-6591 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20070131 ANDA ANDA077712 Major Pharmaceuticals OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 0904-6592_da9423b5-00ab-46fc-8959-3db3c0a0bc6d 0904-6592 HUMAN PRESCRIPTION DRUG TOLTERODINE TARTRATE TOLTERODINE CAPSULE, EXTENDED RELEASE ORAL 20150811 ANDA ANDA203016 Major Pharmaceuticals TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0904-6593_da9423b5-00ab-46fc-8959-3db3c0a0bc6d 0904-6593 HUMAN PRESCRIPTION DRUG TOLTERODINE TARTRATE TOLTERODINE CAPSULE, EXTENDED RELEASE ORAL 20150811 ANDA ANDA203016 Major Pharmaceuticals TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 0904-6594_411e42b1-2bab-49bb-9239-536134b458bf 0904-6594 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA090642 Major Pharmaceuticals VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0904-6595_411e42b1-2bab-49bb-9239-536134b458bf 0904-6595 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA090642 Major Pharmaceuticals VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 0904-6596_49dcf3ae-6d6b-46fe-a88e-ec65f2de332e 0904-6596 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET ORAL 20160525 ANDA ANDA206747 Major Pharmaceuticals VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 0904-6597_255a2c61-0602-4427-9515-2e39bb22575f 0904-6597 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20080627 ANDA ANDA078292 Major Pharmaceuticals DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 0904-6598_255a2c61-0602-4427-9515-2e39bb22575f 0904-6598 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20080627 ANDA ANDA078292 Major Pharmaceuticals DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 0904-6599_1e24bfa8-f4c8-44e1-aa03-693f16f5bc8d 0904-6599 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Major Pharmaceuticals PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0904-6600_1e24bfa8-f4c8-44e1-aa03-693f16f5bc8d 0904-6600 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Major Pharmaceuticals PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0904-6601_1e24bfa8-f4c8-44e1-aa03-693f16f5bc8d 0904-6601 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Major Pharmaceuticals PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 0904-6602_17ec73da-6926-49f1-bfef-cc6ae6872637 0904-6602 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20160502 ANDA ANDA079167 Major Pharmaceuticals ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0904-6603_17ec73da-6926-49f1-bfef-cc6ae6872637 0904-6603 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20160502 ANDA ANDA079167 Major Pharmaceuticals ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0904-6604_17ec73da-6926-49f1-bfef-cc6ae6872637 0904-6604 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20160502 ANDA ANDA079167 Major Pharmaceuticals ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0904-6605_17ec73da-6926-49f1-bfef-cc6ae6872637 0904-6605 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20160502 ANDA ANDA079167 Major Pharmaceuticals ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 0904-6606_b35b1d7b-0b41-4a95-92be-af60cf884bff 0904-6606 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part332 Major Pharmaceuticals DIMETHICONE 125 mg/1 N 20181231 0904-6607_2216844c-9f87-4ca9-a05f-60914fb95b41 0904-6607 HUMAN OTC DRUG Day Time Multi-Symptom Cold/Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 0904-6617_7534a3bb-b4cd-415f-8612-53b37dc6d55f 0904-6617 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20150331 ANDA ANDA040602 Major Pharmaceuticals HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0904-6618_7534a3bb-b4cd-415f-8612-53b37dc6d55f 0904-6618 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20150331 ANDA ANDA040604 Major Pharmaceuticals HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 0904-6622_36284496-e56e-466c-9b56-6007bb5bb699 0904-6622 HUMAN PRESCRIPTION DRUG pyridostigmine bromide pyridostigmine bromide TABLET ORAL 20150807 ANDA ANDA205650 Major Pharmaceuticals PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 0904-6623_0addf3f5-9bd5-4ef3-8c7f-52be20c16cf9 0904-6623 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100514 ANDA ANDA090509 Major Pharmaceuticals TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0904-6624_0addf3f5-9bd5-4ef3-8c7f-52be20c16cf9 0904-6624 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100514 ANDA ANDA090509 Major Pharmaceuticals TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 0904-6627_584401f6-642f-403f-90ce-acdd7b120799 0904-6627 HUMAN OTC DRUG Ear Drops Major Carbamide Peroxide 6.5% LIQUID AURICULAR (OTIC) 20170201 OTC MONOGRAPH FINAL part344 Major Pharmaceuticals CARBAMIDE PEROXIDE 6.5 g/100mL N 20181231 0904-6630_03afce7c-48fd-4798-818a-d778684a2154 0904-6630 HUMAN PRESCRIPTION DRUG amantadine hydrochloride amantadine hydrochloride CAPSULE ORAL 20160804 ANDA ANDA208278 Major Pharmaceuticals AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 0904-6632_9a7894e9-758b-4a37-b4e3-29e3c3cedea9 0904-6632 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Major Pharmaceuticals LORATADINE 5 mg/5mL N 20181231 0904-6633_5640b7c1-067e-56a7-e054-00144ff8d46c 0904-6633 HUMAN OTC DRUG Eye Wash purified water SOLUTION OPHTHALMIC 20170501 OTC MONOGRAPH FINAL part349 Major Pharmaceuticals WATER 99.05 mL/100mL N 20181231 0904-6634_990496b1-7b75-44ca-8b7a-61cf9ca3da11 0904-6634 HUMAN OTC DRUG Cough and Cold Chlorpheniramine maleate, Dextromethorphan HBr TABLET, COATED ORAL 20170331 OTC MONOGRAPH FINAL part341 Major Pharmaceuticals CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 0904-6637_d3b5677c-2265-47c8-beeb-bf12106056ba 0904-6637 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 Major Pharmaceuticals GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 0904-6638_f9447739-9e21-4232-950f-174c0496ab66 0904-6638 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Major Pharmaceuticals QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6639_f9447739-9e21-4232-950f-174c0496ab66 0904-6639 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Major Pharmaceuticals QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6640_f9447739-9e21-4232-950f-174c0496ab66 0904-6640 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Major Pharmaceuticals QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6641_f9447739-9e21-4232-950f-174c0496ab66 0904-6641 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Major Pharmaceuticals QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6642_f9447739-9e21-4232-950f-174c0496ab66 0904-6642 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Major Pharmaceuticals QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6643_f9447739-9e21-4232-950f-174c0496ab66 0904-6643 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Major Pharmaceuticals QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6645_fbdd5a08-5627-4b13-b50f-57b8259ce67e 0904-6645 HUMAN OTC DRUG childrens mapap Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN 160 mg/1 N 20191231 0904-6649_7e5e8669-876e-4d25-bd9c-a68e2b0c038b 0904-6649 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline TABLET ORAL 20080227 ANDA ANDA065425 Major Pharmaceuticals DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 0904-6655_969c17aa-6abc-413c-8561-f1ad8fdde3e5 0904-6655 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 Major Pharmaceuticals ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6656_969c17aa-6abc-413c-8561-f1ad8fdde3e5 0904-6656 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 Major Pharmaceuticals ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 0904-6657_8b0024a3-7b24-454f-aa05-36357595c312 0904-6657 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040627 Major Pharmaceuticals BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 0904-7623_8780c2a6-db8a-4f3c-a411-571deb09e060 0904-7623 HUMAN OTC DRUG Hydrocortisone with Aloe Maximum Strength Hydrocortisone CREAM TOPICAL 20090421 OTC MONOGRAPH NOT FINAL part348 Major Pharmaceuticals HYDROCORTISONE 1 g/100g N 20181231 0904-7651_52f62450-f97a-0607-e054-00144ff8d46c 0904-7651 HUMAN OTC DRUG Extra Strength Mapap PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 0904-7688_aace5eab-0f89-402e-a765-4641060773b6 0904-7688 HUMAN OTC DRUG Anu-Med Phenylephrine Hydrochloride and Fat, Hard SUPPOSITORY RECTAL 19960401 UNAPPROVED DRUG OTHER Major Pharmaceuticals PHENYLEPHRINE HYDROCHLORIDE; FAT, HARD 5; 1.77 mg/1; g/1 N 20181231 0904-7704_9af49ae9-cd69-4eb3-80a7-5cd25cf61861 0904-7704 HUMAN OTC DRUG Aspir Low Aspirin TABLET ORAL 20110524 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ASPIRIN 81 mg/1 N 20181231 0904-7718_83d65fd9-8ac2-48de-8167-bd315f65a329 0904-7718 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110519 ANDA ANDA073618 Major Pharmaceuticals CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 0904-7719_83d65fd9-8ac2-48de-8167-bd315f65a329 0904-7719 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110519 ANDA ANDA073589 Major Pharmaceuticals CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 0904-7720_83d65fd9-8ac2-48de-8167-bd315f65a329 0904-7720 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20110519 ANDA ANDA073607 Major Pharmaceuticals CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 0904-7725_9d36ffe2-6470-4b73-853a-783a091af916 0904-7725 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030224 ANDA ANDA075232 Major Pharmaceuticals LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 0904-7727_5de1ec81-f047-13a4-e053-2a91aa0a7fad 0904-7727 HUMAN OTC DRUG ACID GONE ANTACID aluminum hydroxide and magnesium carbonate LIQUID ORAL 20041230 OTC MONOGRAPH FINAL part331 Major Pharmaceuticals ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 95; 358 mg/15mL; mg/15mL N 20181231 0904-7734_fdb85570-3ed2-4d3b-bbf8-05ea3c89ea1c 0904-7734 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20090421 ANDA ANDA074164 Major Pharmaceuticals MICONAZOLE NITRATE 20 mg/g N 20181231 0904-7760_e3581de3-4f4a-42d6-92da-ef7a8506907b 0904-7760 HUMAN OTC DRUG Clear Anti Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 19950418 OTC MONOGRAPH FINAL part347 Major Pharmaceuticals PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 0904-7809_2d00633a-9a54-433d-ab97-016fe92b409f 0904-7809 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19880229 ANDA ANDA071611 Major Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 0904-7822_6367cfe3-f896-4a3a-8f15-e0a081522419 0904-7822 HUMAN OTC DRUG Major Clotrimazole CLOTRIMAZOLE CREAM TOPICAL 20041004 OTC MONOGRAPH FINAL part333C Major Pharmaceuticals CLOTRIMAZOLE 10 mg/g N 20181231 0904-7889_4c709dfd-49c7-419c-93ce-0a069aba1bba 0904-7889 HUMAN OTC DRUG MAJOR DOK Docusate Sodium DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100423 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM 100 mg/1 N 20181231 0904-7891_8629c164-ed24-4a91-967f-f9c761f59ccc 0904-7891 HUMAN OTC DRUG DOK EXTRA STRENGTH STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20020827 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals DOCUSATE SODIUM 250 mg/1 N 20181231 0904-7912_9468fef9-235a-4d85-9af3-cadd138a18ce 0904-7912 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 19940816 ANDA ANDA072096 Major Pharmaceuticals IBUPROFEN 200 mg/1 N 20181231 0904-7914_f123079b-31d8-4b86-a4e5-3ecdedde4650 0904-7914 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Major Pharmaceuticals IBUPROFEN 200 mg/1 N 20181231 0904-7915_bcc97278-e335-4140-bd5e-fd21bbbbf77f 0904-7915 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 Major Pharmaceuticals IBUPROFEN 200 mg/1 N 20181231 0904-7927_fb1b1f1a-49ad-47e7-b170-e20ca8e4aeb9 0904-7927 HUMAN OTC DRUG Bisacodyl Enteric Coated Bisacodyl TABLET, COATED ORAL 20081024 OTC MONOGRAPH NOT FINAL part334 Major Pharmaceuticals BISACODYL 5 mg/1 N 20181231 0904-7948_352162a3-03dc-4297-ae34-a334d21541ec 0904-7948 HUMAN OTC DRUG Effervescent Pain Relief Fast Relief Fast Relief Aspirin, Citric Acid Anhydrous, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 19960426 OTC MONOGRAPH FINAL part343 Major Pharmaceuticals ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 E 20171231 0904-7955_65443f92-b487-48d4-9ab0-fc1ae5da168b 0904-7955 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 Major Pharmaceuticals CAFFEINE 200 mg/1 N 20181231 0924-0009_55421010-d807-4ca4-e054-00144ff88e88 0924-0009 HUMAN OTC DRUG First Aid Only Alcohol Antiseptic Pad Alcohol Pad SWAB TOPICAL 20170726 OTC MONOGRAPH NOT FINAL part333A Acme United Corporation ISOPROPYL ALCOHOL 70 g/100g N 20181231 0924-0011_915b4e91-de53-4701-ab54-ebd3ec5a216e 0924-0011 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20140708 OTC MONOGRAPH NOT FINAL part333A Acme United Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 0924-0012_ee8eb736-7441-4e06-96dc-0ab27e935dd1 0924-0012 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20160115 OTC MONOGRAPH NOT FINAL part333A Acme United Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 0924-0014_6c9c094f-19b3-4930-ae56-b31b7681c701 0924-0014 HUMAN OTC DRUG Pac-Kit Motion Sickness Dimenhydrinate TABLET, COATED ORAL 20131021 OTC MONOGRAPH FINAL part336 Acme United Corporation DIMENHYDRINATE 50 mg/1 N 20181231 0924-0036_5e31b1ff-2920-7b8c-e053-2a91aa0aedbc 0924-0036 HUMAN OTC DRUG PhysiciansCare Allergy Antihistamine Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20171101 OTC MONOGRAPH FINAL part341 Acme United Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0924-0056_5e31b1ff-2920-7b8c-e053-2a91aa0aedbc 0924-0056 HUMAN OTC DRUG PhysiciansCare Allergy Antihistamine Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20171101 OTC MONOGRAPH FINAL part341 Acme United Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 0924-0075_49978dee-3f71-2532-e054-00144ff88e88 0924-0075 HUMAN OTC DRUG Physicians Care Ibuprofen Ibuprofen 200mg TABLET, COATED ORAL 20160201 ANDA ANDA075010 Acme United Corporation IBUPROFEN 200 mg/1 N 20181231 0924-0076_49978dee-3f5d-2532-e054-00144ff88e88 0924-0076 HUMAN OTC DRUG Physicians Care Ibuprofen Ibuprofen 200mg TABLET, FILM COATED ORAL 20160201 ANDA ANDA079174 Acme United Corporation IBUPROFEN 200 mg/1 N 20181231 0924-0086_49253228-5aad-6ddc-e054-00144ff8d46c 0924-0086 HUMAN OTC DRUG PhysiciansCare Antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20111128 OTC MONOGRAPH FINAL part331 Acme United Corporation CALCIUM CARBONATE 420 mg/1 N 20181231 0924-0087_4a135762-a8e8-4140-e054-00144ff8d46c 0924-0087 HUMAN OTC DRUG PhysiciansCare Antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20120118 OTC MONOGRAPH FINAL part331 Acme United Corporation CALCIUM CARBONATE 420 mg/1 N 20181231 0924-0091_46f0a687-79d5-1d0a-e054-00144ff88e88 0924-0091 HUMAN OTC DRUG PhysiciansCare Allergy Multi-Symptom Relief Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20111223 OTC MONOGRAPH FINAL part341 Acme United Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 0924-0092_49978dee-3f84-2532-e054-00144ff88e88 0924-0092 HUMAN OTC DRUG Physicians Care Allergy Plus acetaminophen 325mg, chlorpheniramine maleate 2mg,phenylephrine HCl 5mg TABLET, FILM COATED ORAL 20111223 OTC MONOGRAPH FINAL part341 Acme United Corporation PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 5; 325; 2 mg/1; mg/1; mg/1 N 20181231 0924-0104_49979756-45d0-25eb-e054-00144ff88e88 0924-0104 HUMAN OTC DRUG Physicians Care Aspirin Aspirin 325mg TABLET, COATED ORAL 20150224 OTC MONOGRAPH FINAL part343 Acme United Corporation ASPIRIN 325 mg/1 N 20181231 0924-0123_499827c6-f21d-631e-e054-00144ff8d46c 0924-0123 HUMAN OTC DRUG PhysiciansCare Non Aspirin Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20120120 OTC MONOGRAPH NOT FINAL part343 Acme United Corporation ACETAMINOPHEN 500 mg/1 N 20181231 0924-0128_4989ecf0-d771-4cc8-e054-00144ff88e88 0924-0128 HUMAN OTC DRUG PhysiciansCare Non Aspirin Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20120120 OTC MONOGRAPH NOT FINAL part343 Acme United Corporation ACETAMINOPHEN 500 mg/1 N 20181231 0924-0130_4dee6551-817e-3aa1-e054-00144ff8d46c 0924-0130 HUMAN OTC DRUG Physicians Care Extra Strength Pain Reliever Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20130927 OTC MONOGRAPH NOT FINAL part343 Acme United Corporation ASPIRIN; ACETAMINOPHEN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 0924-0133_49978dee-3fd4-2532-e054-00144ff88e88 0924-0133 HUMAN OTC DRUG PhysiciansCare Sinus Non-Drowsy Phenylephrine HCL TABLET, FILM COATED ORAL 20120129 OTC MONOGRAPH FINAL part341 Acme United Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 0924-0134_49978dee-3f96-2532-e054-00144ff88e88 0924-0134 HUMAN OTC DRUG Physicians Care Sinus Phenykephrine HCl 10mg TABLET, COATED ORAL 20150602 OTC MONOGRAPH FINAL part341 Acme United PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 0924-0141_4e2b6881-58bb-6963-e054-00144ff88e88 0924-0141 HUMAN OTC DRUG Physicians Care Cold Cough Acetaminophen, Dextromethorphan Hydrbromide, Guaifenesin, Phenylephrine Hydrochloride TABLET ORAL 20130513 OTC MONOGRAPH FINAL part341 Acme United Corporation GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 200; 5; 325; 15 mg/1; mg/1; mg/1; mg/1 N 20181231 0924-0150_4e02223d-f34c-333e-e054-00144ff8d46c 0924-0150 HUMAN OTC DRUG Physicians Care Cough and Sore Throat Menthol LOZENGE ORAL 20150105 OTC MONOGRAPH FINAL part341 Acme United Corporation MENTHOL 7.6 mg/1 N 20181231 0924-0160_c55a1e12-9562-4af6-9fbc-152e2a0e8e03 0924-0160 HUMAN OTC DRUG PhysiciansCare Ophthalmic Solution Eyewash Purified Water 98.3% SOLUTION OPHTHALMIC 20130624 NDA NDA022305 Acme United Corporation WATER 929 g/946mL N 20181231 0924-0162_41a6cb62-68f6-4cad-92f4-236fa573dfcf 0924-0162 HUMAN OTC DRUG PhysiciansCare Ophthalmic Solution Eyewash Purified Water 98.3% SOLUTION OPHTHALMIC 20130624 NDA NDA022305 Acme United Corporation WATER 929 g/946mL N 20181231 0924-0165_29ca5d06-b6e2-4db0-e054-00144ff88e88 0924-0165 HUMAN OTC DRUG PhysiciansCare Eye Wash Water SOLUTION OPHTHALMIC 20141205 OTC MONOGRAPH FINAL part349 Acme United Corporation WATER .98 mL/mL N 20181231 0924-0167_f1e14684-f01a-49e4-8b54-6349ffb209fb 0924-0167 HUMAN OTC DRUG Physicians Care Eye Wash Sterile Buffered Isotonic Water SOLUTION OPHTHALMIC 20160229 OTC MONOGRAPH FINAL part349 Acme United Corporation WATER .98 mL/mL E 20171231 0924-0168_0d6a80bf-b969-6bbf-e054-00144ff88e88 0924-0168 HUMAN OTC DRUG PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3% Purified Water 98.3% SOLUTION OPHTHALMIC 20150124 NDA NDA022305 Acme United Corporation WATER 929 g/946mL E 20171231 0924-0169_2a3eaefd-e6b6-4655-e054-00144ff88e88 0924-0169 HUMAN OTC DRUG PhysiciansCare Eyewash Station Additive Concentrate chlorhexidine gluconate and propylene glycol liquid SOLUTION OPHTHALMIC 20160126 OTC MONOGRAPH NOT FINAL part349 Acme United Corporation PROPYLENE GLYCOL; CHLORHEXIDINE GLUCONATE 280; 145.6 kg/2800L; kg/2800L N 20181231 0924-0170_8b0216cb-84c1-4726-b900-c3b53a567ae6 0924-0170 HUMAN OTC DRUG First Aid Only Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20141126 OTC MONOGRAPH FINAL part344 Acme United Corp. ISOPROPYL ALCOHOL 700 mL/L N 20181231 0924-0171_f70a3e23-ca61-43ee-8f95-9c58261de24d 0924-0171 HUMAN OTC DRUG First Aid Only Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20141126 OTC MONOGRAPH NOT FINAL part333A Acme United Corp. HYDROGEN PEROXIDE 30 mL/L N 20181231 0924-0930_b47d713f-dded-4ae9-b4ce-0611370b2f41 0924-0930 HUMAN OTC DRUG Burn Lidocaine Hydrochloride SPRAY TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part348 Acme United Corp LIDOCAINE HYDROCHLORIDE 20 mg/L N 20181231 0924-0931_805d6309-6f3b-4fe1-847e-875f392edbf3 0924-0931 HUMAN OTC DRUG Antiseptic First Aid benzalkonium chloride and benzocaine SPRAY TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333A Acme United Corp BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/g; mg/g N 20181231 0924-0932_01b556c0-ed33-48e0-9b07-5ce6502d09c2 0924-0932 HUMAN OTC DRUG Hydrogen Peroxide Antiseptic Hydrogen Peroxide SPRAY TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333A Acme United Corp HYDROGEN PEROXIDE 30 mL/L N 20181231 0924-0933_45d5fe73-17f5-4979-aa01-592667cb20e5 0924-0933 HUMAN OTC DRUG Isopropyl Alcohol Antiseptic Isopropyl Alcohol SPRAY TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333A Acme United Corp ISOPROPYL ALCOHOL 700 mL/L N 20181231 0924-1006_3568bc0f-c8c4-4bee-a5ef-27fc4bfa4784 0924-1006 HUMAN OTC DRUG PhysiciansCare Dimenhydrinate Motion Sickness Relief Dimenhydrinate TABLET, COATED ORAL 20131005 OTC MONOGRAPH FINAL part336 Acme United Corporation DIMENHYDRINATE 50 mg/1 N 20181231 0924-1132_47fbceb4-3309-4cba-8a7d-62fb4f7d7b6b 0924-1132 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20151106 OTC MONOGRAPH NOT FINAL part348 Acme United Corp HYDROCORTISONE 10 mg/g N 20181231 0924-1805_3b31e3d8-a8aa-4329-8a06-3292db39dfca 0924-1805 HUMAN OTC DRUG ACME Small Cuts and Burns BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20100430 OTC MONOGRAPH FINAL part333 Acme United Corp. N 20181231 0924-1806_9f71f835-9965-4409-9cbe-44b04a0b0022 0924-1806 HUMAN OTC DRUG ACME FIRST AID Contains 404 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN, BENZOCAINE, ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20100427 OTC MONOGRAPH FINAL part333 Acme United Corp. N 20181231 0924-1807_bbe4198a-e8fb-4d98-b197-0dbeee82e056 0924-1807 HUMAN OTC DRUG BLUE ACME SLEEVE FIRST AID Contains 1000 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, BENZALKONIUM CHLORIDE, WATER, ISOPROPYL ALCOHOL, ASPIRIN, BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE KIT 20100427 OTC MONOGRAPH FINAL part333 Acme United Corp. N 20181231 0924-5000_9d1b4838-a709-49ca-a44a-5bd62a4e88e2 0924-5000 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride GEL TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part348 Acme United Corporation LIDOCAINE HYDROCHLORIDE 20 mg/g N 20181231 0924-5200_938711b2-8c6b-4a29-8770-d29ecf1693ed 0924-5200 HUMAN OTC DRUG Sting Relief alcohol, lidocaine hydrochloride CLOTH TOPICAL 20120306 OTC MONOGRAPH NOT FINAL part333E Acme United Corporation ALCOHOL; LIDOCAINE HYDROCHLORIDE .5; 20 mL/mL; mg/mL N 20181231 0924-5201_5087cbbd-1bbf-62ed-e054-00144ff8d46c 0924-5201 HUMAN OTC DRUG First Aid Only Sting Relief Pad Benzocaine PATCH TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part348 Acme United Corporation BENZOCAINE 6 g/100g N 20181231 0924-5603_29d034b8-1c10-4319-894e-67abf6507cb8 0924-5603 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20120127 OTC MONOGRAPH FINAL part333B Acme United Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 0924-5603_589803b1-7e58-4e60-9ac5-b17fe07d0474 0924-5603 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Acme United Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 0924-5603_88a6e851-4ee2-49e8-a918-546cf5f17797 0924-5603 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Acme United Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 0924-5607_60a1dbf8-c3ba-105f-e053-2991aa0aa5c7 0924-5607 HUMAN OTC DRUG First Aid Only Antibiotic Neomycin Sulfate Antibiotic Ointment OINTMENT TOPICAL 20171218 OTC MONOGRAPH FINAL part333B Acme United Corporation NEOMYCIN SULFATE 3.5 mg/g N 20181231 0924-5701_13a4cc55-fca1-4da7-8eeb-656331653b58 0924-5701 HUMAN OTC DRUG First Aid and Burn Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20120127 OTC MONOGRAPH NOT FINAL part333A Acme United Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g N 20181231 0924-5701_3a6943c0-276c-4e76-a2a8-948163263d18 0924-5701 HUMAN OTC DRUG First Aid and Burn Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20120127 OTC MONOGRAPH NOT FINAL part333A Acme United Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g N 20181231 0924-5701_f71543e8-a6fb-4d21-9e89-f77005322002 0924-5701 HUMAN OTC DRUG First Aid and Burn Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20120127 OTC MONOGRAPH NOT FINAL part333A Acme United Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g N 20181231 0924-7110_38524256-4667-42db-85b9-d88cbc359dbe 0924-7110 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E Acme United Corporation BENZALKONIUM CHLORIDE 1.2478 g/L N 20181231 0924-7111_504b7eca-eec7-31f2-e054-00144ff8d46c 0924-7111 HUMAN OTC DRUG First Aid Only BZK Antiseptic Towelette Benzalkonium Chloride PATCH TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part333A Acme United Corporation BENZALKONIUM CHLORIDE .13 g/100g N 20181231 0924-8110_509b6c8e-6aa0-2656-e054-00144ff8d46c 0924-8110 HUMAN OTC DRUG First Aid Only Povidone-Iodine Prep Pad Povidone-Iodine PATCH TOPICAL 20170724 OTC MONOGRAPH NOT FINAL part333A Acme United Corporation POVIDONE-IODINE 10 g/100g N 20181231 0927-0086_453fc814-196d-4e5c-9cdb-90278039a4c1 0927-0086 HUMAN OTC DRUG Dri-Ear Drops isopropyl alcohol LIQUID AURICULAR (OTIC) 19960930 OTC MONOGRAPH FINAL part344 Pfeiffer Pharmaceuticals, Inc ISOPROPYL ALCOHOL .76 g/mL N 20181231 0941-0409_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0409 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 538; 448; 18.3; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0411_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0411 HUMAN PRESCRIPTION DRUG DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 538; 448; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0413_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0413 HUMAN PRESCRIPTION DRUG DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 538; 448; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0415_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0415 HUMAN PRESCRIPTION DRUG DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 538; 448; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0424_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0424 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19921204 NDA NDA020183 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 538; 448; 18.3; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0426_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0426 HUMAN PRESCRIPTION DRUG DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19921204 NDA NDA020163 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 538; 448; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0427_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0427 HUMAN PRESCRIPTION DRUG DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19921204 NDA NDA020163 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 538; 448; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0429_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0429 HUMAN PRESCRIPTION DRUG DIANEAL PD-2 with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19921204 NDA NDA020163 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 538; 448; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 0941-0430_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0430 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19921204 NDA NDA020183 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 538; 448; 18.3; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0433_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0433 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19921204 NDA NDA020183 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 538; 448; 18.3; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0457_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0457 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 538; 448; 18.3; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0459_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0459 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 538; 448; 18.3; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0464_88728f52-a9ba-497c-b8c6-889f6bb35fe7 0941-0464 HUMAN PRESCRIPTION DRUG DIANEAL FOR PERITONEAL DIALYSIS anhydrouse dextrose, sodium chloride, sodium lactate, calcium chloride, magnesium chloride INJECTION, SOLUTION INTRAPERITONEAL 20141027 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation ANHYDROUS DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 13.6; 5.38; 4.48; .184; .051 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0465_88728f52-a9ba-497c-b8c6-889f6bb35fe7 0941-0465 HUMAN PRESCRIPTION DRUG DIANEAL FOR PERITONEAL DIALYSIS anhydrous dextrose, sodium chloride, sodium lactate, calcium chloride, magnesium chloride INJECTION, SOLUTION INTRAPERITONEAL 20141027 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation ANHYDROUS DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 22.7; 5.38; 4.48; .184; .051 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0466_88728f52-a9ba-497c-b8c6-889f6bb35fe7 0941-0466 HUMAN PRESCRIPTION DRUG DIANEAL FOR PERITONEAL DIALYSIS anhydrous dextrose, sodium chloride, sodium lactate, calcium chloride, magnesium chloride INJECTION, SOLUTION INTRAPERITONEAL 20141027 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Baxter Healthcare Corporation ANHYDROUS DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 38.6; 5.38; 4.48; .184; .051 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0472_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0472 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 538; 448; 18.3; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0475_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0475 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 538; 448; 18.3; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0484_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0484 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 538; 448; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0487_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0487 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 538; 448; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0490_6d9fd6ae-32fd-4d62-910d-dd2f4f6fa9b4 0941-0490 HUMAN PRESCRIPTION DRUG DIANEAL Low Calcium with Dextrose sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose INJECTION, SOLUTION INTRAPERITONEAL 19780927 NDA NDA017512 Baxter Healthcare Corporation DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 538; 448; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0941-0679_3ab6f82d-5a8d-4eaf-82b8-15be5ec3a1df 0941-0679 HUMAN PRESCRIPTION DRUG EXTRANEAL icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride INJECTION, SOLUTION INTRAPERITONEAL 20021220 NDA NDA021321 Baxter Healthcare Corporation ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 7.5; 535; 448; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 0942-0641_1f546c80-456a-4fd7-984a-902a0a4305f6 0942-0641 HUMAN PRESCRIPTION DRUG ACD-A Anticoagulant Citrate Dextrose Solution Formula A SOLUTION INTRAVENOUS 20070301 NDA BN160918 Fenwal Inc DEXTROSE MONOHYDRATE; SODIUM CITRATE; ANHYDROUS CITRIC ACID 24.5; 22; 7.3 g/1000mL; g/1000mL; g/1000mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 0942-0641_35ba5cb0-f707-4b7d-bb85-0ebc46ba0a5e 0942-0641 HUMAN PRESCRIPTION DRUG ACD-A Anticoagulant Citrate Dextrose Solution Formula A SOLUTION INTRAVENOUS 20070301 NDA BN160918 Fenwal Inc DEXTROSE MONOHYDRATE; SODIUM CITRATE; ANHYDROUS CITRIC ACID 12.25; 11; 3.65 g/500mL; g/500mL; g/500mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 0942-6301_b702ab32-f32a-46fd-81d5-04280102a994 0942-6301 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; 209; 155; 19.3 g/70mL; g/70mL; mg/70mL; mg/70mL; mg/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6305_bb15753f-ec9d-4fa5-b63b-7d3b429ba031 0942-6305 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2; 1.66; 188; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6307_2b4d29fd-6ed3-47d8-b63b-18d960f6d274 0942-6307 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; 209; 155; 19.3 g/70mL; g/70mL; mg/70mL; mg/70mL; mg/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6308_7b79aac0-9151-4559-beac-b30bbff5de1b 0942-6308 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; 209; 155; 19.3 g/70mL; g/70mL; mg/70mL; mg/70mL; mg/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6309_29199a9b-0778-4344-ac42-690ac41fc3dd 0942-6309 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2; 1.66; 188; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6312_7664c2b2-9088-414c-93b8-28924a076a9a 0942-6312 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; 209; 155; 19.3 g/70mL; g/70mL; mg/70mL; mg/70mL; mg/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6316_44716649-800d-4404-b6fa-7ec9981f3cbf 0942-6316 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070620 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; 209; 155; 19.3 g/70mL; g/70mL; mg/70mL; mg/70mL; mg/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6317_78c745fb-0230-4c14-9b58-6c22b97e7a7a 0942-6317 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2; 1.66; 188; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6319_c57c487a-57cf-4366-a4a8-0674ea5b1717 0942-6319 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2; 1.66; 188; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6320_cf77e2c0-343e-4a1e-9479-f90bf3246707 0942-6320 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070604 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; 209; 155; 19.3 g/70mL; g/70mL; mg/70mL; mg/70mL; mg/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6321_41e6b368-ce10-4a6b-a25c-42ce690b0eb0 0942-6321 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070601 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 1.12; 921; 105; 78; 9.6 g/35mL; mg/35mL; mg/35mL; mg/35mL; mg/35mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6322_c225c6cc-620c-43c1-8ad2-777c82aacd87 0942-6322 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070624 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2; 1.66; 188; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6326_dfb7c531-0785-4adf-a6aa-c8872b9e8ad9 0942-6326 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20081215 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; 209; 155; 19.3 g/70mL; g/70mL; mg/70mL; mg/70mL; mg/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6327_d3367c79-636e-4386-933e-440ab2d74378 0942-6327 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100517 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2; 1.66; 188; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6328_b673b012-03f7-4da2-b81b-596b828df0bd 0942-6328 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100525 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 1.56; 1.29; 147; 109; 13.5 g/49mL; g/49mL; mg/49mL; mg/49mL; mg/49mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6329_5a9b3a98-86e3-487f-8c3a-cff931ac5bf7 0942-6329 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100525 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 1.56; 1.29; 147; 109; 13.5 g/49mL; g/49mL; mg/49mL; mg/49mL; mg/49mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6330_a62e19c3-f02b-4e27-9778-77431dd40a5c 0942-6330 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100525 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2; 1.66; 188; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6331_6dd6db7b-c92c-4a7c-89e1-af9ec514e4f8 0942-6331 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100525 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 1.56; 1.29; 160; 109; 13.5 g/49mL; g/49mL; mg/49mL; mg/49mL; mg/49mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6332_8fed2b42-6fe4-4119-84bf-6bd944c3e174 0942-6332 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100621 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 1.56; 1.29; 160; 109; 13.5 g/49mL; g/49mL; mg/49mL; mg/49mL; mg/49mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6336_32795354-94c1-4d58-a2c9-7d863f3a42ee 0942-6336 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100621 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.01; 1.66; 206; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6343_eeccc690-f8b2-4466-aa12-084e339e91e9 0942-6343 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20100819 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.01; 1.66; 206; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6344_5b78ea45-7fff-4978-9a94-1dd1ae1699d9 0942-6344 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20121204 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.01; 1.66; 206; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-6430_cd3be06b-eb6d-4942-b2c2-315fa4058e11 0942-6430 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6431_839203f8-d96e-4f25-a295-766f368117d1 0942-6431 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6436_91c480ae-9f42-4f58-b06f-da6b95d189f5 0942-6436 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6439_d3789974-14dd-4b5d-93a8-444ec2358a88 0942-6439 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6444_2df5ff68-5ed7-4578-8852-f0016318a1db 0942-6444 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6445_d34e2f5a-48ce-416b-8267-bfdb5f02af28 0942-6445 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6449_b2c36152-4942-42e6-b404-e4675e11882c 0942-6449 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6453_20d8ae2c-e075-4258-81c4-1da40ecdd7a1 0942-6453 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6457_fd6894fd-7522-4bfa-b2bc-9b1af4efbbc4 0942-6457 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6458_c9be865c-0e28-44a3-a666-9f8b6c71a4d2 0942-6458 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6459_f3ff7291-f1a6-4fb4-a122-4d724a8daae5 0942-6459 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6461_33585755-27e9-467b-867c-5e56938ad0a2 0942-6461 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6462_c0c6647a-351f-40e3-b236-68eb4c3fb77e 0942-6462 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6464_09dc1b38-828d-42e1-8ee7-2f2268a93e60 0942-6464 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6466_0ca1dfd7-8b95-4ddd-a675-fd1006290369 0942-6466 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6470_ea24df0e-4e26-4f08-9c8e-282863b9d2a3 0942-6470 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6475_8263b939-c2f9-421f-adbd-72d1cb51c368 0942-6475 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070301 NDA BN811104 Fenwal, Inc. N 20181231 0942-6476_77135eb2-a981-409d-a019-b1a7e12846b3 0942-6476 HUMAN PRESCRIPTION DRUG CPD/ADSOL Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20071001 NDA BN811104 Fenwal, Inc. N 20181231 0942-6477_0b4d6e7d-be79-46f6-8ab1-ffbd4ec87951 0942-6477 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20071001 NDA BN811104 Fenwal, Inc. N 20181231 0942-6478_ff4ecfbc-eec7-4940-ba47-214d6248e5fc 0942-6478 HUMAN PRESCRIPTION DRUG CPD/ADSOL Red Cell Preservation Solution System (PL 2209) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20080131 NDA BN900223 Fenwal, Inc. N 20181231 0942-6479_fc791891-11a8-45ab-9c7b-44fc43bb0c2d 0942-6479 HUMAN PRESCRIPTION DRUG CPD/ADSOL Red Cell Preservation Solution System (PL 2209) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20080131 NDA BN900223 Fenwal, Inc. N 20181231 0942-6481_4c43203c-7cec-4dfc-bf43-a0a8d958de28 0942-6481 HUMAN PRESCRIPTION DRUG CPD/ADSOL Red Cell Preservation Solution System (PL 2209) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20080201 NDA BN900223 Fenwal, Inc. N 20181231 0942-6482_d9b89fdf-0cdc-49a1-9eeb-0848750e4ac5 0942-6482 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070611 NDA BN811104 Fenwal, Inc. N 20181231 0942-6483_5c032f20-266e-4c2c-bfd5-f9b1ed1d7ece 0942-6483 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20080210 NDA BN811104 Fenwal, Inc. N 20181231 0942-6484_3da271c8-622f-42aa-a2cf-2b00223a5279 0942-6484 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070606 NDA BN811104 Fenwal, Inc. N 20181231 0942-6485_2ba48b17-3344-44bf-a44b-6a8026387ac1 0942-6485 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070606 NDA BN811104 Fenwal, Inc. N 20181231 0942-6486_7a894247-b4da-4fd7-88c1-18d397ed6265 0942-6486 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070501 NDA BN811104 Fenwal, Inc. N 20181231 0942-6487_698a0a7c-93c7-428e-8ba9-0e063c9099ba 0942-6487 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070606 NDA BN811104 Fenwal, Inc. N 20181231 0942-6488_1b16d05f-7318-410a-9fcf-5c171e5bae92 0942-6488 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070604 NDA BN811104 Fenwal, Inc. N 20181231 0942-6489_e018a5fd-77a9-426c-8aba-c45c00237323 0942-6489 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20070604 NDA BN811104 Fenwal, Inc. N 20181231 0942-6492_639c54e4-313b-4027-8c83-b40558b221ee 0942-6492 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20090515 NDA BN811104 Fenwal, Inc. N 20181231 0942-6493_c6da1be0-f33f-4d03-a055-34b7bd4d68b8 0942-6493 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20090515 NDA BN811104 Fenwal, Inc. N 20181231 0942-6494_f7d4932d-4267-441f-b8dc-992620eeacd4 0942-6494 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20100525 NDA BN811104 Fenwal, Inc. N 20181231 0942-6495_e3030250-8359-49f3-8048-6708924b5958 0942-6495 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20100525 NDA BN811104 Fenwal, Inc. N 20181231 0942-6496_148024cd-1131-447e-8c77-afa887fe1446 0942-6496 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20100621 NDA BN811104 Fenwal, Inc. N 20181231 0942-6499_f5e14917-85c8-4de7-aff1-9263044d10af 0942-6499 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20100928 NDA BN811104 Fenwal, Inc. N 20181231 0942-6501_248a7ecc-47e9-406b-9e16-35118c062cbb 0942-6501 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20110304 NDA BN811104 Fenwal, Inc. N 20181231 0942-6502_eb50456b-336d-4c24-85f4-3e1d86336add 0942-6502 HUMAN PRESCRIPTION DRUG ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20110111 NDA BN811104 Fenwal, Inc. N 20181231 0942-6503_50b163ad-1bdf-4f3c-990b-2c45131845f0 0942-6503 HUMAN PRESCRIPTION DRUG CPD/ADSOL Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution KIT 20130213 NDA BN811104 Fenwal, Inc. N 20181231 0942-6504_85d64c9a-de03-4601-84a9-15894fd6aa70 0942-6504 HUMAN PRESCRIPTION DRUG ADSOL RED CELL PRESERVATION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC) anticoagulant citrate phosphate dextrose (cpd) and adsol preservation kit KIT 20170228 NDA BN811104 Fenwal, Inc. N 20181231 0942-6505_7640b8c6-58fa-4392-959a-d324ec17e0df 0942-6505 HUMAN PRESCRIPTION DRUG CPD/ADSOL anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution kit KIT 20170228 NDA BN811104 Fenwal, Inc. N 20181231 0942-6506_d376e9af-75bc-4156-9d19-f840bcab8b05 0942-6506 HUMAN PRESCRIPTION DRUG ADSOL RED CELL PRESERVATION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC) anticoagulant citrate phosphate dextrose (cpd) and adsol preservation kit KIT 20170228 NDA BN811104 Fenwal, Inc. N 20181231 0942-6507_e8ddb2b6-1939-4641-91bd-5de3abfdab82 0942-6507 HUMAN PRESCRIPTION DRUG ADSOL RED CELL PRESERVATION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC) anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution kit KIT 20170228 NDA BN811104 Fenwal, Inc. N 20181231 0942-6508_60925039-1b6f-4211-9363-655f9c7eda9f 0942-6508 HUMAN PRESCRIPTION DRUG ADSOL RED CELL PRESERVATION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC) anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution kit KIT 20170228 NDA BN811104 Fenwal, Inc. N 20181231 0942-9001_8a8c6bd9-c20b-4960-9314-7c9be34605c7 0942-9001 HUMAN PRESCRIPTION DRUG ACD Blood-Pack Units (PL 146 Plastic) Anticoagulant Citrate Dextrose (ACD) SOLUTION INTRAVENOUS 20070301 NDA BN160918 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID 1.65; 1.48; 493 g/67.5mL; g/67.5mL; mg/67.5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-9005_bf4444ef-bff1-46c8-b11d-99091f14262d 0942-9005 HUMAN PRESCRIPTION DRUG ACD-A Antiocoagulant Citrate Dextrose Solution, Formula A SOLUTION INTRAVENOUS 20121024 NDA BN160918 Fenwal Inc. DEXTROSE MONOHYDRATE; SODIUM CITRATE; ANHYDROUS CITRIC ACID 2.45; 2.2; 730 g/100mL; g/100mL; mg/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-9201_d1a26b01-7b75-4adb-b72c-9eff5976324a 0942-9201 HUMAN PRESCRIPTION DRUG Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic Anticoagulant Citrate Phosphate Dextrose (CPD) Solution SOLUTION INTRAVENOUS 20070301 NDA BN170401 Fenwal, Inc. TRISODIUM CITRATE DIHYDRATE; DEXTROSE MONOHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 921; 893; 105; 78 mg/35mL; mg/35mL; mg/35mL; mg/35mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-9202_3875335e-b6f8-4d53-98bf-e9c3b09f56d9 0942-9202 HUMAN PRESCRIPTION DRUG Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 Plastic Anticoagulant Citrate Phosphate Dextrose (CPD) SOLUTION INTRAVENOUS 20070331 NDA BN170401 Fenwal, Inc. TRISODIUM CITRATE DIHYDRATE; DEXTROSE MONOHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.66; 1.61; 188; 140 g/63mL; g/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-9206_78fada3f-c891-4ffa-b78b-3cb9b83595ca 0942-9206 HUMAN PRESCRIPTION DRUG CPD Anticoagulant Citrate Phosphate Dextrose (CPD) SOLUTION INTRAVENOUS 20070301 NDA BN170401 Fenwal, Inc. TRISODIUM CITRATE DIHYDRATE; DEXTROSE MONOHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.66; 1.61; 188; 140 g/63mL; g/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-9304_895c186e-a6c3-4a0e-b5a8-f373ae0ca6b4 0942-9304 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2; 1.66; 188; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-9393_429b6520-df50-4ba8-8051-8ae84f929f9a 0942-9393 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; 209; 155; 19.3 g/70mL; g/70mL; mg/70mL; mg/70mL; mg/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-9394_40490799-1495-4496-b770-ad4ab5cc4874 0942-9394 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Solution SOLUTION INTRAVENOUS 20070301 NDA BN077420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2; 1.66; 188; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-9395_8836720c-9b27-4cc7-a25f-9f7e69258dd3 0942-9395 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; 209; 155; 19.3 g/70mL; g/70mL; mg/70mL; mg/70mL; mg/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-9398_18724dde-3988-4f3f-8df6-2e00478c4089 0942-9398 HUMAN PRESCRIPTION DRUG CPDA-1 Anticoagulant Citrate Phosphate Dextrose Adenine SOLUTION INTRAVENOUS 20070301 NDA BN770420 Fenwal, Inc. DEXTROSE MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; ANHYDROUS CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2; 1.66; 188; 140; 17.3 g/63mL; g/63mL; mg/63mL; mg/63mL; mg/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-9502_b1211b76-47e8-4d6f-bbcd-d63327328977 0942-9502 HUMAN PRESCRIPTION DRUG Sodium Citrate Blood-Pack Units, (PL 146 Plastic) Anticoagulant Sodium Citrate Solution SOLUTION INTRAVENOUS 20070301 NDA BN770923 Fenwal, Inc. TRISODIUM CITRATE DIHYDRATE 2 g/50mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0942-9504_578a66d5-9489-497e-953e-66d9ed7d991b 0942-9504 HUMAN PRESCRIPTION DRUG Sodium Citrate Blood-Pack Units, (PL 146 Plastic) Anticoagulant Sodium Citrate Solution SOLUTION INTRAVENOUS 20070301 NDA BN770923 Fenwal, Inc. TRISODIUM CITRATE DIHYDRATE 4 g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 0942-9505_2376bc6e-1255-474f-a5cd-0dd934ecd50b 0942-9505 HUMAN PRESCRIPTION DRUG Sodium Citrate Blood-Pack Units, (PL 146 Plastic) Anticoagulant Sodium Citrate Solution SOLUTION INTRAVENOUS 20070301 NDA BN770923 Fenwal, Inc. TRISODIUM CITRATE DIHYDRATE 4 g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 0942-9601_8f548120-da1d-4bcd-bcbe-2fed425d842c 0942-9601 HUMAN PRESCRIPTION DRUG InterSol Platelet Additive 3 SOLUTION INTRAVENOUS 20121025 NDA BN080041 Fenwal, Inc. SODIUM CHLORIDE; SODIUM ACETATE; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 452; 442; 318; 305; 93 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 0944-0490_2d4ce1ae-31d8-495e-855b-e1a587631e67 0944-0490 PLASMA DERIVATIVE Buminate Albumin Human INJECTION, SOLUTION INTRAVENOUS 19540317 BLA BLA101452 Baxalta US Inc. ALBUMIN HUMAN .25 g/mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 0944-0491_57c9a4db-97c6-40bf-81a1-b1ce7174f27c 0944-0491 PLASMA DERIVATIVE BUMINATE Albumin Human INJECTION, SOLUTION INTRAVENOUS 19550616 BLA BLA101452 Baxalta US Inc. ALBUMIN HUMAN .05 g/mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 0944-0493_70257164-41dd-45da-ae6b-a011a4b21be6 0944-0493 PLASMA DERIVATIVE FLEXBUMIN Albumin Human SOLUTION INTRAVENOUS 20020809 BLA BLA101452 Baxalta US Inc. ALBUMIN HUMAN .25 g/mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 0944-0495_eb67169a-753a-473f-9478-dc79ad32af30 0944-0495 PLASMA DERIVATIVE Flexbumin Albumin Human INJECTION, SOLUTION INTRAVENOUS 20140731 BLA BLA101452 Baxalta US Inc. ALBUMIN HUMAN .05 g/mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 0944-2510_70e8128c-e8ec-407e-bc4a-f2bd279101af 0944-2510 PLASMA DERIVATIVE HYQVIA Immune Globulin 10 percent (Human) with Recombinant Human Hyaluronidase KIT 20140912 BLA BLA125402 Baxalta US Inc. N 20191231 0944-2511_70e8128c-e8ec-407e-bc4a-f2bd279101af 0944-2511 PLASMA DERIVATIVE HYQVIA Immune Globulin 10 percent (Human) with Recombinant Human Hyaluronidase KIT 20140912 BLA BLA125402 Baxalta US Inc. N 20191231 0944-2512_70e8128c-e8ec-407e-bc4a-f2bd279101af 0944-2512 PLASMA DERIVATIVE HYQVIA Immune Globulin 10 percent (Human) with Recombinant Human Hyaluronidase KIT 20140912 BLA BLA125402 Baxalta US Inc. N 20191231 0944-2513_70e8128c-e8ec-407e-bc4a-f2bd279101af 0944-2513 PLASMA DERIVATIVE HYQVIA Immune Globulin 10 percent (Human) with Recombinant Human Hyaluronidase KIT 20140912 BLA BLA125402 Baxalta US Inc. N 20191231 0944-2514_70e8128c-e8ec-407e-bc4a-f2bd279101af 0944-2514 PLASMA DERIVATIVE HYQVIA Immune Globulin 10 percent (Human) with Recombinant Human Hyaluronidase KIT 20140912 BLA BLA125402 Baxalta US Inc. N 20191231 0944-2620_2046ae55-1613-427f-9e0f-d677b8cf8fd5 0944-2620 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation E 20171231 0944-2620_26d73f6e-25b7-42b4-bf2e-903bc4c9f2f7 0944-2620 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation E 20171231 0944-2620_84bf3b45-f329-408d-a971-55c098f92cb0 0944-2620 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation E 20171231 0944-2620_edde1d5d-4162-4749-ae3f-691b19d16456 0944-2620 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19980501 BLA BLA103133 Baxalta US Inc. E 20171231 0944-2623_b178c06a-655b-4dc0-a0d0-a99278a1d014 0944-2623 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation E 20171231 0944-2625_b178c06a-655b-4dc0-a0d0-a99278a1d014 0944-2625 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation E 20171231 0944-2627_b178c06a-655b-4dc0-a0d0-a99278a1d014 0944-2627 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation E 20171231 0944-2655_9b7b09f9-1232-4ca1-a7cd-f3a37eafd2eb 0944-2655 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxalta US Inc. E 20171231 0944-2655_ac8b6376-290c-43df-b560-c2182bf9b029 0944-2655 PLASMA DERIVATIVE GAMMAGARD S/D HUMAN IMMUNOGLOBULIN G KIT 20110103 BLA BLA103133 Baxter Healthcare Corporation E 20171231 0944-2656_56452f6e-47f6-4b37-b68d-3619f33fe717 0944-2656 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation E 20171231 0944-2658_56452f6e-47f6-4b37-b68d-3619f33fe717 0944-2658 PLASMA DERIVATIVE GAMMAGARD S/D Human Immunoglobulin G KIT 19940510 BLA BLA103133 Baxter Healthcare Corporation E 20171231 0944-2700_76e55346-6849-4560-bd2b-e38719ab2f73 0944-2700 PLASMA DERIVATIVE GAMMAGARD Liquid Immune Globulin Infusion (Human) INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050427 BLA BLA125105 Baxalta US Inc. HUMAN IMMUNOGLOBULIN G 100 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 0944-2814_b4a79907-28d8-4859-af23-33ffb83823f3 0944-2814 PLASMA DERIVATIVE Aralast NP Alpha-1-Proteinase Inhibitor (Human) KIT 20021223 BLA BLA125039 Baxalta U.S. Inc. N 20181231 0944-2815_b4a79907-28d8-4859-af23-33ffb83823f3 0944-2815 PLASMA DERIVATIVE Aralast NP Alpha-1-Proteinase Inhibitor (Human) KIT 20021223 BLA BLA125039 Baxalta U.S. Inc. N 20181231 0944-2831_6eb61ecd-d264-4163-ba11-26d4816062f3 0944-2831 HUMAN PRESCRIPTION DRUG Recombinate Antihemophilic Factor Recombinant KIT 20100208 BLA BLA103375 Baxter Healthcare Corporation N 20181231 0944-2831_cf92d5c9-abd7-4d3d-95c8-687d966bd747 0944-2831 HUMAN PRESCRIPTION DRUG Recombinate Antihemophilic Factor Recombinant KIT 20100208 BLA BLA103375 Baxter Healthcare Corporation N 20181231 0944-2832_6eb61ecd-d264-4163-ba11-26d4816062f3 0944-2832 HUMAN PRESCRIPTION DRUG Recombinate Antihemophilic Factor Recombinant KIT 20100208 BLA BLA103375 Baxter Healthcare Corporation N 20181231 0944-2832_cf92d5c9-abd7-4d3d-95c8-687d966bd747 0944-2832 HUMAN PRESCRIPTION DRUG Recombinate Antihemophilic Factor Recombinant KIT 20100208 BLA BLA103375 Baxter Healthcare Corporation N 20181231 0944-2833_6eb61ecd-d264-4163-ba11-26d4816062f3 0944-2833 HUMAN PRESCRIPTION DRUG Recombinate Antihemophilic Factor Recombinant KIT 20100208 BLA BLA103375 Baxter Healthcare Corporation N 20181231 0944-2833_cf92d5c9-abd7-4d3d-95c8-687d966bd747 0944-2833 HUMAN PRESCRIPTION DRUG Recombinate Antihemophilic Factor Recombinant KIT 20100208 BLA BLA103375 Baxter Healthcare Corporation N 20181231 0944-2841_b921870b-dbf7-406d-bc59-5b40d85fe011 0944-2841 PLASMA DERIVATIVE RECOMBINATE antihemophilic factor recombinant KIT 20090410 BLA BLA103375 Baxalta US Inc. N 20181231 0944-2842_b921870b-dbf7-406d-bc59-5b40d85fe011 0944-2842 PLASMA DERIVATIVE RECOMBINATE antihemophilic factor recombinant KIT 20090410 BLA BLA103375 Baxalta US Inc. N 20181231 0944-2843_b921870b-dbf7-406d-bc59-5b40d85fe011 0944-2843 PLASMA DERIVATIVE RECOMBINATE antihemophilic factor recombinant KIT 20090410 BLA BLA103375 Baxalta US Inc. N 20181231 0944-2844_b921870b-dbf7-406d-bc59-5b40d85fe011 0944-2844 PLASMA DERIVATIVE RECOMBINATE antihemophilic factor recombinant KIT 20100315 BLA BLA103375 Baxalta US Inc. N 20181231 0944-2845_b921870b-dbf7-406d-bc59-5b40d85fe011 0944-2845 PLASMA DERIVATIVE RECOMBINATE antihemophilic factor recombinant KIT 20100315 BLA BLA103375 Baxalta US Inc. N 20181231 0944-2850_a75cce13-0654-4513-bdd0-a3f50a36d47b 0944-2850 PLASMA DERIVATIVE CUVITRU Human Immunoglobulin G INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20161018 BLA BLA125596 Baxalta US Inc. HUMAN IMMUNOGLOBULIN G 1 g/5mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 0944-2884_f4f45338-0292-4ce0-877d-8bdb7d4b1e38 0944-2884 PLASMA DERIVATIVE GLASSIA .ALPHA.1-PROTEINASE INHIBITOR HUMAN INJECTION, SOLUTION INTRAVENOUS 20100701 BLA BLA125325 Baxalta USA Inc. .ALPHA.1-PROTEINASE INHIBITOR HUMAN 1 g/50mL Human alpha-1 Proteinase Inhibitor [EPC],Trypsin Inhibitors [MoA] N 20181231 0944-2921_608d779c-a215-4425-92d3-1b626c641922 0944-2921 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20030725 BLA BLA125063 Baxalta US Inc. N 20191231 0944-2922_608d779c-a215-4425-92d3-1b626c641922 0944-2922 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20120712 BLA BLA125063 Baxalta US Inc. N 20191231 0944-2923_608d779c-a215-4425-92d3-1b626c641922 0944-2923 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20120712 BLA BLA125063 Baxalta US Inc. N 20191231 0944-2924_608d779c-a215-4425-92d3-1b626c641922 0944-2924 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20120712 BLA BLA125063 Baxalta US Inc. N 20191231 0944-2948_608d779c-a215-4425-92d3-1b626c641922 0944-2948 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20120712 BLA BLA125063 Baxalta US Inc. N 20191231 0944-2964_608d779c-a215-4425-92d3-1b626c641922 0944-2964 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20060412 BLA BLA125063 Baxalta US Inc. N 20191231 0944-2965_608d779c-a215-4425-92d3-1b626c641922 0944-2965 PLASMA DERIVATIVE ADVATE Antihemophilic Factor, Human Recombinant KIT 20070703 BLA BLA125063 Baxalta US Inc. N 20191231 0944-3026_bcc558e5-86e2-42f2-933c-97e6bbab8fb2 0944-3026 PLASMA DERIVATIVE RIXUBIS COAGULATION FACTOR IX (RECOMBINANT) KIT 20131004 BLA BLA125446 BAXALTA US INC. N 20181231 0944-3028_bcc558e5-86e2-42f2-933c-97e6bbab8fb2 0944-3028 PLASMA DERIVATIVE RIXUBIS COAGULATION FACTOR IX (RECOMBINANT) KIT 20131004 BLA BLA125446 BAXALTA US INC. N 20181231 0944-3030_bcc558e5-86e2-42f2-933c-97e6bbab8fb2 0944-3030 PLASMA DERIVATIVE RIXUBIS COAGULATION FACTOR IX (RECOMBINANT) KIT 20131004 BLA BLA125446 BAXALTA US INC. N 20181231 0944-3032_bcc558e5-86e2-42f2-933c-97e6bbab8fb2 0944-3032 PLASMA DERIVATIVE RIXUBIS COAGULATION FACTOR IX (RECOMBINANT) KIT 20131004 BLA BLA125446 BAXALTA US INC. N 20181231 0944-3034_bcc558e5-86e2-42f2-933c-97e6bbab8fb2 0944-3034 PLASMA DERIVATIVE RIXUBIS COAGULATION FACTOR IX (RECOMBINANT) KIT 20131004 BLA BLA125446 BAXALTA US INC. N 20181231 0944-3045_24f21d80-294c-4c89-b3f8-29715a254ed9 0944-3045 PLASMA DERIVATIVE ADVATE Antihemophilic Factor (Recombinant) KIT 20060412 BLA BLA125063 Baxalta US Inc. N 20191231 0944-3046_24f21d80-294c-4c89-b3f8-29715a254ed9 0944-3046 PLASMA DERIVATIVE ADVATE Antihemophilic Factor (Recombinant) KIT 20070703 BLA BLA125063 Baxalta US Inc. N 20191231 0944-3047_24f21d80-294c-4c89-b3f8-29715a254ed9 0944-3047 PLASMA DERIVATIVE ADVATE Antihemophilic Factor (Recombinant) KIT 20120712 BLA BLA125063 Baxalta US Inc. N 20191231 0944-3051_24f21d80-294c-4c89-b3f8-29715a254ed9 0944-3051 PLASMA DERIVATIVE ADVATE Antihemophilic Factor (Recombinant) KIT 20111215 BLA BLA125063 Baxalta US Inc. N 20191231 0944-3052_24f21d80-294c-4c89-b3f8-29715a254ed9 0944-3052 PLASMA DERIVATIVE ADVATE Antihemophilic Factor (Recombinant) KIT 20111215 BLA BLA125063 Baxalta US Inc. N 20191231 0944-3053_24f21d80-294c-4c89-b3f8-29715a254ed9 0944-3053 PLASMA DERIVATIVE ADVATE Antihemophilic Factor (Recombinant) KIT 20111215 BLA BLA125063 Baxalta US Inc. N 20191231 0944-3054_24f21d80-294c-4c89-b3f8-29715a254ed9 0944-3054 PLASMA DERIVATIVE ADVATE Antihemophilic Factor (Recombinant) KIT 20111215 BLA BLA125063 Baxalta US Inc. N 20191231 0944-3810_1139a1c4-b773-44c5-a97d-9f53c51df142 0944-3810 HUMAN PRESCRIPTION DRUG ONCASPAR Pegaspargase INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19940201 BLA BLA103411 Baxalta US Inc. PEGASPARGASE 750 [iU]/mL Asparaginase [Chemical/Ingredient],Asparagine-specific Enzyme [EPC] N 20181231 0944-3940_db4ab540-f22d-407e-98c6-0a4260073226 0944-3940 PLASMA DERIVATIVE HEMOFIL M antihemophilic factor human KIT 19880223 BLA BLA101448 BAXALTA US Inc. N 20181231 0944-3942_db4ab540-f22d-407e-98c6-0a4260073226 0944-3942 PLASMA DERIVATIVE HEMOFIL M antihemophilic factor human KIT 19880223 BLA BLA101448 BAXALTA US Inc. N 20181231 0944-3944_db4ab540-f22d-407e-98c6-0a4260073226 0944-3944 PLASMA DERIVATIVE HEMOFIL M antihemophilic factor human KIT 19880223 BLA BLA101448 BAXALTA US Inc. N 20181231 0944-3946_db4ab540-f22d-407e-98c6-0a4260073226 0944-3946 PLASMA DERIVATIVE HEMOFIL M antihemophilic factor human KIT 19880223 BLA BLA101448 BAXALTA US Inc. N 20181231 0944-4175_8d79a18f-cca1-4a81-8564-b839a645063c 0944-4175 HUMAN PRESCRIPTION DRUG CEPROTIN Protein C Concentrate Human KIT 20100809 BLA BLA125234 Baxter Healthcare Corporation E 20171231 0944-4177_a07435c1-3d81-4e6e-b8ae-0107a44ffe81 0944-4177 PLASMA DERIVATIVE CEPROTIN Protein C Concentrate Human KIT 20100809 BLA BLA125234 Baxalta US Inc. N 20181231 0944-4179_a07435c1-3d81-4e6e-b8ae-0107a44ffe81 0944-4179 PLASMA DERIVATIVE CEPROTIN Protein C Concentrate Human KIT 20100809 BLA BLA125234 Baxalta US Inc. N 20181231 0944-4201_106365cb-71aa-4c20-af32-5bbfe8cbf191 0944-4201 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 20110218 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4201_c21e996f-e555-4b27-9da7-cf0600953646 0944-4201 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 20110218 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4201_dc1d15c7-757f-470f-83c2-14b3d6512483 0944-4201 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 20110218 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4201_e1aca067-0c96-4025-88bc-bd2345a46a30 0944-4201 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 20110218 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4210_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-4210 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4210_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-4210 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4211_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-4211 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4211_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-4211 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4212_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-4212 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4212_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-4212 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4252_5f31090d-4f4d-4bff-99ee-14ee21867f37 0944-4252 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20151113 BLA BLA125566 Baxalta US Inc. N 20181231 0944-4254_5f31090d-4f4d-4bff-99ee-14ee21867f37 0944-4254 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20151113 BLA BLA125566 Baxalta US Inc. N 20181231 0944-4256_5f31090d-4f4d-4bff-99ee-14ee21867f37 0944-4256 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20161025 BLA BLA125566 Baxalta US Inc. N 20181231 0944-4258_5f31090d-4f4d-4bff-99ee-14ee21867f37 0944-4258 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20151113 BLA BLA125566 Baxalta US Inc. N 20181231 0944-4260_5f31090d-4f4d-4bff-99ee-14ee21867f37 0944-4260 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20161025 BLA BLA125566 Baxalta US Inc. N 20181231 0944-4262_5f31090d-4f4d-4bff-99ee-14ee21867f37 0944-4262 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20151113 BLA BLA125566 Baxalta US Inc. N 20181231 0944-4301_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-4301 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4301_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-4301 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4302_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-4302 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4302_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-4302 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4303_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-4303 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4303_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-4303 PLASMA DERIVATIVE TISSEEL fibrinogen human and thrombin human KIT 19980501 BLA BLA103980 Baxter Healthcare Corporation N 20181231 0944-4351_77e8fcef-6033-431a-bccd-361bd193a379 0944-4351 PLASMA DERIVATIVE ARTISS Fibrinogen human Thrombin human KIT 20080319 BLA BLA125266 Baxter Healthcare Corporation N 20191231 0944-4351_906c38fb-0400-4440-8cc8-de27b2836640 0944-4351 PLASMA DERIVATIVE ARTISS Fibrinogen Human Thrombin Human KIT 20080319 BLA BLA125266 Baxter Healthcare Corporation N 20191231 0944-4351_91150c14-6245-43ba-9915-00e61b8fca97 0944-4351 PLASMA DERIVATIVE ARTISS Fibrinogen Human Thrombin Human KIT 20080319 BLA BLA125266 Baxter Healthcare Corporation N 20191231 0944-4351_bc16500a-1363-4468-a475-79345e4ad77a 0944-4351 PLASMA DERIVATIVE ARTISS Fibrinogen Human Thrombin Human KIT 20080319 BLA BLA125266 Baxter Healthcare Corporation N 20191231 0944-4622_f5422fec-dce2-4218-8a95-d882d7db5cd7 0944-4622 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20151113 BLA BLA125566 Baxalta US Inc. N 20181231 0944-4623_f5422fec-dce2-4218-8a95-d882d7db5cd7 0944-4623 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20151113 BLA BLA125566 Baxalta US Inc. N 20181231 0944-4624_f5422fec-dce2-4218-8a95-d882d7db5cd7 0944-4624 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20161025 BLA BLA125566 Baxalta US Inc. N 20181231 0944-4625_f5422fec-dce2-4218-8a95-d882d7db5cd7 0944-4625 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20151113 BLA BLA125566 Baxalta US Inc. N 20181231 0944-4626_f5422fec-dce2-4218-8a95-d882d7db5cd7 0944-4626 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20161025 BLA BLA125566 Baxalta US Inc. N 20181231 0944-4627_f5422fec-dce2-4218-8a95-d882d7db5cd7 0944-4627 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20151113 BLA BLA125566 Baxalta US Inc. N 20181231 0944-4628_f5422fec-dce2-4218-8a95-d882d7db5cd7 0944-4628 PLASMA DERIVATIVE ADYNOVATE Antihemophilic Factor (Recombinant) PEGylated KIT 20161025 BLA BLA125566 Baxalta US Inc. N 20181231 0944-5001_c1c14e68-540b-4230-9726-5a0250e4917a 0944-5001 PLASMA DERIVATIVE OBIZUR Antihemophilic Factor (Recombinant), Porcine Sequence KIT 20141023 BLA BLA125512 Baxalta US Inc. N 20191231 0944-7551_fb63e49c-e86b-4163-adf3-4d22d4c69fe1 0944-7551 PLASMA DERIVATIVE VONVENDI von Willebrand Factor (Recombinant) KIT 20151208 BLA BLA125577 Baxalta US Inc. N 20191231 0944-7553_fb63e49c-e86b-4163-adf3-4d22d4c69fe1 0944-7553 PLASMA DERIVATIVE VONVENDI von Willebrand Factor (Recombinant) KIT 20151208 BLA BLA125577 Baxalta US Inc. N 20191231 0944-8402_60e8272e-2a7d-42a5-af4b-3dbf727dd68f 0944-8402 PLASMA DERIVATIVE TISSEEL Frozen fibrinogen human and thrombin human SOLUTION TOPICAL 19980501 BLA BLA103980 Baxter Healthcare Corporation FIBRINOGEN HUMAN; THROMBIN HUMAN 90; 500 [iU]/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 0944-8402_7d7abda1-9b76-43b2-8f74-0e376d9fe264 0944-8402 PLASMA DERIVATIVE TISSEEL Frozen fibrinogen human and thrombin human SOLUTION TOPICAL 19980501 BLA BLA103980 Baxter Healthcare Corporation FIBRINOGEN HUMAN; THROMBIN HUMAN 90; 500 [iU]/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 0944-8402_c21e996f-e555-4b27-9da7-cf0600953646 0944-8402 PLASMA DERIVATIVE TISSEEL Frozen fibrinogen human and thrombin human SOLUTION TOPICAL 20110218 BLA BLA103980 Baxter Healthcare Corporation FIBRINOGEN; THROMBIN HUMAN 90; 500 [iU]/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 0944-8503_183b59f6-1e19-4a35-86f2-b2e77fdb2709 0944-8503 HUMAN PRESCRIPTION DRUG ARTISS Frozen Fibrinogen human Thrombin human SOLUTION TOPICAL 20110111 20190630 BLA BLA125266 Baxalta US Inc. FIBRINOGEN HUMAN; HUMAN THROMBIN 90; 4 mg/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20191231 0944-8503_77e8fcef-6033-431a-bccd-361bd193a379 0944-8503 PLASMA DERIVATIVE ARTISS Frozen Fibrinogen Human Thrombin Human SOLUTION TOPICAL 20090319 BLA BLA125266 Baxter Healthcare Corporation FIBRINOGEN HUMAN; THROMBIN HUMAN 90; 4 mg/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20191231 0944-8503_93219f6d-1ea7-45cc-9ecf-c3dd92c7db9d 0944-8503 HUMAN PRESCRIPTION DRUG ARTISS Frozen Fibrinogen Human Thrombin Human SOLUTION TOPICAL 20080308 20190731 BLA BLA125266 Baxalta US Inc. FIBRINOGEN HUMAN; HUMAN THROMBIN 90; 4 mg/mL; [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20191231 0944-8701_e7ac607f-3b8c-4e7f-aaec-e9421b020e62 0944-8701 HUMAN PRESCRIPTION DRUG TachoSil THROMBIN HUMAN and FIBRINOGEN PATCH TOPICAL 20100405 20200531 BLA BLA125351 Baxalta US Inc. HUMAN THROMBIN; FIBRINOGEN HUMAN 2; 5.5 [USP'U]/1; mg/1 Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 0944-8702_e7ac607f-3b8c-4e7f-aaec-e9421b020e62 0944-8702 HUMAN PRESCRIPTION DRUG TachoSil THROMBIN HUMAN and FIBRINOGEN PATCH TOPICAL 20100405 20200531 BLA BLA125351 Baxalta US Inc. HUMAN THROMBIN; FIBRINOGEN HUMAN 2; 5.5 [USP'U]/1; mg/1 Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 0944-8703_e7ac607f-3b8c-4e7f-aaec-e9421b020e62 0944-8703 HUMAN PRESCRIPTION DRUG TachoSil THROMBIN HUMAN and FIBRINOGEN PATCH TOPICAL 20100405 20200531 BLA BLA125351 Baxalta US Inc. HUMAN THROMBIN; FIBRINOGEN HUMAN 2; 5.5 [USP'U]/1; mg/1 Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 0955-0251_5da66115-88b5-43e0-8a3b-69b71c65b4dc 0955-0251 HUMAN PRESCRIPTION DRUG Ergocalciferol ergocalciferol CAPSULE, LIQUID FILLED ORAL 20091110 NDA AUTHORIZED GENERIC NDA003444 Winthrop U.S. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] E 20171231 0955-1003_474de5fb-0bb7-4939-8189-5ff9352dd7c8 0955-1003 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 0955-1004_474de5fb-0bb7-4939-8189-5ff9352dd7c8 0955-1004 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 0955-1006_474de5fb-0bb7-4939-8189-5ff9352dd7c8 0955-1006 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 0955-1008_474de5fb-0bb7-4939-8189-5ff9352dd7c8 0955-1008 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 0955-1010_474de5fb-0bb7-4939-8189-5ff9352dd7c8 0955-1010 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 0955-1012_474de5fb-0bb7-4939-8189-5ff9352dd7c8 0955-1012 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 0955-1015_474de5fb-0bb7-4939-8189-5ff9352dd7c8 0955-1015 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 0955-1016_474de5fb-0bb7-4939-8189-5ff9352dd7c8 0955-1016 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20111003 NDA AUTHORIZED GENERIC NDA020164 Winthrop U.S. ENOXAPARIN SODIUM 300 mg/3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 0955-1020_ea887537-d6ab-45f3-8b8c-447e14f2722a 0955-1020 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20101021 NDA AUTHORIZED GENERIC NDA020449 Winthrop U.S. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0955-1021_ea887537-d6ab-45f3-8b8c-447e14f2722a 0955-1021 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20101021 NDA AUTHORIZED GENERIC NDA020449 Winthrop U.S. DOCETAXEL 80 mg/4mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0955-1022_ea887537-d6ab-45f3-8b8c-447e14f2722a 0955-1022 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20161023 NDA AUTHORIZED GENERIC NDA020449 Winthrop U.S. DOCETAXEL 160 mg/8mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 0955-1025_1be09629-8df0-4a8a-998b-fc6d651f5409 0955-1025 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride levocetirizine dihydrochloride TABLET, FILM COATED ORAL 20070809 NDA NDA022064 Winthrop U.S. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 0955-1026_1be09629-8df0-4a8a-998b-fc6d651f5409 0955-1026 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride levocetirizine dihydrochloride SOLUTION ORAL 20080402 NDA NDA022157 Winthrop U.S. LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 0955-1030_374a094f-5f1b-49a8-86a9-06780b524679 0955-1030 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, SUGAR COATED ORAL 20140401 NDA AUTHORIZED GENERIC NDA014399 Winthrop U.S. DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 0955-1031_374a094f-5f1b-49a8-86a9-06780b524679 0955-1031 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, SUGAR COATED ORAL 20140401 NDA AUTHORIZED GENERIC NDA014399 Winthrop U.S. DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 0955-1032_374a094f-5f1b-49a8-86a9-06780b524679 0955-1032 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, SUGAR COATED ORAL 20140401 NDA AUTHORIZED GENERIC NDA014399 Winthrop U.S. DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 0955-1033_374a094f-5f1b-49a8-86a9-06780b524679 0955-1033 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, SUGAR COATED ORAL 20140401 NDA AUTHORIZED GENERIC NDA014399 Winthrop U.S. DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 0955-1034_374a094f-5f1b-49a8-86a9-06780b524679 0955-1034 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, SUGAR COATED ORAL 20140401 NDA AUTHORIZED GENERIC NDA014399 Winthrop U.S. DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 0955-1035_374a094f-5f1b-49a8-86a9-06780b524679 0955-1035 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, SUGAR COATED ORAL 20140401 NDA AUTHORIZED GENERIC NDA014399 Winthrop U.S. DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] E 20171231 0955-1037_9188940f-72bf-428e-8c6a-789e0fe24a78 0955-1037 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20120123 NDA NDA017681 Winthrop U.S. METHENAMINE HIPPURATE 1 g/1 E 20171231 0955-1050_19b271b9-e09d-43db-88b8-abc9fe274feb 0955-1050 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate Sevelamer Carbonate TABLET, FILM COATED ORAL 20171018 NDA AUTHORIZED GENERIC NDA022127 Winthrop U.S. SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0955-1052_19b271b9-e09d-43db-88b8-abc9fe274feb 0955-1052 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate Sevelamer Carbonate POWDER, FOR SUSPENSION ORAL 20180101 NDA AUTHORIZED GENERIC NDA022318 Winthrop U.S. SEVELAMER CARBONATE .8 g/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0955-1054_19b271b9-e09d-43db-88b8-abc9fe274feb 0955-1054 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate Sevelamer Carbonate POWDER, FOR SUSPENSION ORAL 20180101 NDA AUTHORIZED GENERIC NDA022318 Winthrop U.S. SEVELAMER CARBONATE 2.4 g/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 0955-1702_cd146c74-b304-4135-90d1-0c50fbb6490c 0955-1702 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101014 NDA AUTHORIZED GENERIC NDA021774 Winthrop U.S, a business of sanofi-aventis U.S. LLC ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0955-1703_cd146c74-b304-4135-90d1-0c50fbb6490c 0955-1703 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101206 NDA AUTHORIZED GENERIC NDA021774 Winthrop U.S, a business of sanofi-aventis U.S. LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 0955-1710_d163acd6-53cc-4c6c-b2bc-e11af28f7181 0955-1710 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE SPRAY, METERED NASAL 20110615 NDA AUTHORIZED GENERIC NDA020468 Winthrop U.S. TRIAMCINOLONE ACETONIDE 55 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0955-1720_a8dd3bc5-71e9-45d7-9efb-7106495c1167 0955-1720 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20170417 NDA NDA020862 Winthrop U.S. DOXERCALCIFEROL .5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 0955-1721_a8dd3bc5-71e9-45d7-9efb-7106495c1167 0955-1721 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20170417 NDA NDA020862 Winthrop U.S. DOXERCALCIFEROL 1 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 0955-1722_a8dd3bc5-71e9-45d7-9efb-7106495c1167 0955-1722 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20170417 NDA NDA020862 Winthrop U.S. DOXERCALCIFEROL 2.5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 0955-1725_d8acf0f4-9a54-4b7d-86bb-848ea24e2b39 0955-1725 HUMAN PRESCRIPTION DRUG OXALIPLATIN oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140707 NDA AUTHORIZED GENERIC NDA021759 Winthrop U.S. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0955-1727_d8acf0f4-9a54-4b7d-86bb-848ea24e2b39 0955-1727 HUMAN PRESCRIPTION DRUG OXALIPLATIN oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140707 NDA AUTHORIZED GENERIC NDA021759 Winthrop U.S. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 0955-1731_904a6f96-4bdc-4cef-b169-48f9c227e5e6 0955-1731 HUMAN PRESCRIPTION DRUG OXALIPLATIN oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20150901 NDA AUTHORIZED GENERIC NDA021759 Winthrop U.S. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20191231 0955-1733_904a6f96-4bdc-4cef-b169-48f9c227e5e6 0955-1733 HUMAN PRESCRIPTION DRUG OXALIPLATIN oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20150901 NDA AUTHORIZED GENERIC NDA021759 Winthrop U.S. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20191231 0955-1735_520bebc4-8d69-4cb0-9404-7595e710b0d6 0955-1735 HUMAN PRESCRIPTION DRUG Leflunomide leflunomide TABLET, FILM COATED ORAL 20150907 NDA NDA020905 Winthrop U.S. LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] N 20181231 0955-1737_520bebc4-8d69-4cb0-9404-7595e710b0d6 0955-1737 HUMAN PRESCRIPTION DRUG Leflunomide leflunomide TABLET, FILM COATED ORAL 20150907 NDA NDA020905 Winthrop U.S. LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] N 20181231 0955-1746_d5edb873-461d-47ce-8337-ce24d6151828 0955-1746 HUMAN PRESCRIPTION DRUG clofarabine clofarabine INJECTION INTRAVENOUS 20170511 NDA AUTHORIZED GENERIC NDA021673 sanofi-aventis U.S. LLC CLOFARABINE 1 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 0998-0016_44fe0982-e65d-4ecb-baaf-9b48aaa95e54 0998-0016 HUMAN PRESCRIPTION DRUG Alcaine proparacaine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19731019 ANDA ANDA080027 Alcon Laboratories, Inc. PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] N 20181231 0998-0203_33ab98d9-0195-46a9-9eb7-92f55eff616e 0998-0203 HUMAN PRESCRIPTION DRUG ISOPTO CARPINE pilocarpine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19740101 NDA NDA200890 Alcon Laboratories, Inc. PILOCARPINE HYDROCHLORIDE 10 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 0998-0204_33ab98d9-0195-46a9-9eb7-92f55eff616e 0998-0204 HUMAN PRESCRIPTION DRUG ISOPTO CARPINE pilocarpine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19740101 NDA NDA200890 Alcon Laboratories, Inc. PILOCARPINE HYDROCHLORIDE 20 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 0998-0206_33ab98d9-0195-46a9-9eb7-92f55eff616e 0998-0206 HUMAN PRESCRIPTION DRUG ISOPTO CARPINE pilocarpine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19740101 NDA NDA200890 Alcon Laboratories, Inc. PILOCARPINE HYDROCHLORIDE 40 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 0998-0355_4a30f1ba-24c7-4e89-8293-4d33c64e69ab 0998-0355 HUMAN PRESCRIPTION DRUG Mydriacyl tropicamide SOLUTION/ DROPS OPHTHALMIC 19590401 ANDA ANDA084306 Alcon Laboratories, Inc. TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 0998-0408_7887de8a-760d-4394-8d0e-79cfcd122656 0998-0408 HUMAN OTC DRUG Isopto Tears Hypromellose 2910 SOLUTION OPHTHALMIC 19900930 OTC MONOGRAPH FINAL part349 Alcon Laboratories, Inc. HYPROMELLOSE 2910 (4000 MPA.S) 5 mg/mL N 20181231 0998-0615_7a8d8c4e-c8a9-4dc6-8290-d259f6d438f5 0998-0615 HUMAN PRESCRIPTION DRUG Maxidex dexamethasone SUSPENSION OPHTHALMIC 19660515 NDA NDA013422 Alcon Laboratories, Inc. DEXAMETHASONE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 0998-0630_557bddc5-13ca-4f3f-92cc-df4767029748 0998-0630 HUMAN PRESCRIPTION DRUG Maxitrol neomycin sulfate, polymyxin b sulfate and dexamethasone SUSPENSION OPHTHALMIC 19641115 NDA NDA050023 Alcon Laboratories, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10006-001_b8f5cc28-1546-47a9-9bc0-d60fa9745df9 10006-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company OXYGEN 99 L/100L E 20171231 10006-002_c4065ed6-237f-4545-bad2-a51e95a70949 10006-002 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company NITROUS OXIDE 99 L/100L E 20171231 10006-003_90f9a709-879d-4308-9287-862c93c0f12b 10006-003 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company CARBON DIOXIDE 99 kg/100kg Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 10006-004_a8b5c8ac-a3f7-4184-8ccf-020926d48fe0 10006-004 HUMAN PRESCRIPTION DRUG MEDICAL AIR AIR GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company OXYGEN 21 L/100L E 20171231 10006-005_8bed956b-282d-414d-95fb-d33d0693800a 10006-005 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company NITROGEN 99 L/100L E 20171231 10006-008_73d34d59-69b0-4bc0-b31d-617aa0d5b3fc 10006-008 HUMAN PRESCRIPTION DRUG HELIUM HELIUM GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company HELIUM 99 L/100L E 20171231 10006-009_1366bd51-4f64-48d6-baa1-1fb402553331 10006-009 HUMAN PRESCRIPTION DRUG HELIOX HELIOX GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company OXYGEN 20 L/100L E 20171231 10006-010_1366bd51-4f64-48d6-baa1-1fb402553331 10006-010 HUMAN PRESCRIPTION DRUG HELIOX HELIOX GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company OXYGEN 25 L/100L E 20171231 10006-011_1366bd51-4f64-48d6-baa1-1fb402553331 10006-011 HUMAN PRESCRIPTION DRUG HELIOX HELIOX GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Acetylene Oxygen Company OXYGEN 30 L/100L E 20171231 10014-001_60a3db4d-390b-df46-e053-2a91aa0a39c0 10014-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19721006 NDA NDA205840 Aero All Gas Company OXYGEN 990 mL/L N 20181231 10014-002_60a4387c-f32a-a80a-e053-2991aa0a4a84 10014-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19721006 NDA NDA205839 Aero All Gas Company NITROGEN 990 mL/L N 20181231 10014-003_60a48699-d1cd-4a18-e053-2991aa0a4109 10014-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19721006 NDA NDA206009 Aero All Gas Company NITROUS OXIDE 990 mL/L N 20181231 10014-004_33a96071-5ca7-4b61-bdea-547ba3e2c7d3 10014-004 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19721006 NDA NDA206826 Aero All Gas Company HELIUM 990 mL/L N 20181231 10014-005_4f12824d-2513-45d2-b1c0-f389b973a3a2 10014-005 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19721006 NDA NDA205846 Aero All Gas Company CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 10014-006_94c04484-ab76-4efe-a49b-7477cb935446 10014-006 HUMAN PRESCRIPTION DRUG Oxygen Helium Mixture Oxygen Helium Mixture GAS RESPIRATORY (INHALATION) 19721006 UNAPPROVED MEDICAL GAS Aero All Gas Company OXYGEN; HELIUM 200; 800 mL/L; mL/L E 20171231 10014-007_0b1b75b5-757c-4382-8811-01a71f648641 10014-007 HUMAN PRESCRIPTION DRUG Oxygen Helium Mixture 40/60 Oxygen Helium Mixture 40/60 GAS RESPIRATORY (INHALATION) 19721006 UNAPPROVED MEDICAL GAS Aero All Gas Company OXYGEN; HELIUM 400; 600 mL/L; mL/L E 20171231 10014-008_60ceae28-235b-19a0-e053-2a91aa0a2a24 10014-008 HUMAN PRESCRIPTION DRUG Oxygen Helium Mixture 40/60 Oxygen Helium Mixture 40/60 GAS RESPIRATORY (INHALATION) 19721006 NDA NDA205840 Aero All Gas Company OXYGEN 400 mL/L N 20181231 10014-009_60ced542-19d4-57d5-e053-2a91aa0a49be 10014-009 HUMAN PRESCRIPTION DRUG Oxygen Helium Mixture Oxygen Helium Mixture GAS RESPIRATORY (INHALATION) 19721006 NDA NDA205840 Aero All Gas Company OXYGEN 200 mL/L N 20181231 10014-018_60cee881-419a-10bb-e053-2a91aa0afce7 10014-018 HUMAN PRESCRIPTION DRUG Oxygen Helium Mixture 30/70 Oxygen Helium Mixture 30/70 GAS RESPIRATORY (INHALATION) 19721006 NDA NDA205840 Aero All Gas Company OXYGEN 300 mL/L N 20181231 10018-8999_48d0d09a-35bd-4501-b481-5bb4aaaaacb2 10018-8999 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20050101 NDA NDA205865 Air Products and Chemicals, Inc. OXYGEN 990 mL/L N 20181231 10018-9502_3af5f7cf-fe0a-4b44-8acd-b5c48286d500 10018-9502 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20050101 NDA NDA205866 Air Products and Chemicals, Inc. NITROGEN 990 mL/L N 20181231 10018-9505_6bbe6aca-7f15-4823-9440-abba441bcbe0 10018-9505 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 20050101 NDA NDA205864 Air Products and Chemicals, Inc. HELIUM 990 mL/L N 20181231 10019-055_b12ea3fc-85e7-4ab6-a8db-54f5ebaebd6e 10019-055 HUMAN PRESCRIPTION DRUG Brevibloc Esmolol Hydrochloride INJECTION INTRAVENOUS 19861231 NDA NDA019386 Baxter Healthcare Corporation ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 10019-063_5bca8860-de02-4c7f-bb43-01dfe4aea139 10019-063 HUMAN PRESCRIPTION DRUG Adenosine ADENOSINE INJECTION, SOLUTION INTRAVENOUS 20100420 ANDA ANDA076501 Baxter Healthcare Corporation ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 10019-075_b12ea3fc-85e7-4ab6-a8db-54f5ebaebd6e 10019-075 HUMAN PRESCRIPTION DRUG Brevibloc Esmolol Hydrochloride INJECTION INTRAVENOUS 19861231 NDA NDA019386 Baxter Healthcare Corporation ESMOLOL HYDROCHLORIDE 20 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 10019-098_b53894b3-fbe7-4acd-bf50-9d14c47ee3c8 10019-098 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20030930 ANDA ANDA065125 BAXTER HEALTHCARE CORPORATION CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10019-115_b12ea3fc-85e7-4ab6-a8db-54f5ebaebd6e 10019-115 HUMAN PRESCRIPTION DRUG Brevibloc Esmolol Hydrochloride INJECTION INTRAVENOUS 19861231 NDA NDA019386 Baxter Healthcare Corporation ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 10019-120_55688c8d-46e2-4e5f-ace5-2a12b878c719 10019-120 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride Esmolol Hydrochloride INJECTION INTRAVENOUS 19861231 NDA NDA019386 Baxter Healthcare Corporation ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 10019-360_eab990cb-4961-4fd5-ae64-e5e9beffdb65 10019-360 HUMAN PRESCRIPTION DRUG FORANE isoflurane INHALANT RESPIRATORY (INHALATION) 19791218 NDA NDA017624 Baxter Healthcare Corporation ISOFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 10019-553_9caea3f4-e7e2-4d24-b3b6-5e62f37b3ec8 10019-553 HUMAN PRESCRIPTION DRUG Transderm Scop Scopalamine PATCH, EXTENDED RELEASE TRANSDERMAL 20030101 NDA NDA017874 Baxter Healthcare Corporation SCOPOLAMINE 1 mg/3d Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 10019-553_a2ac9eb6-6e0e-4342-a7b9-9fbca31570f6 10019-553 HUMAN PRESCRIPTION DRUG Transderm Scop Scopalamine PATCH, EXTENDED RELEASE TRANSDERMAL 20161201 NDA NDA017874 Baxter Healthcare Corporation SCOPOLAMINE 1 mg/3d Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 10019-641_b4793a92-d7a0-4276-b5a5-21ac74a0c0bc 10019-641 HUMAN PRESCRIPTION DRUG SUPRANE desflurane LIQUID RESPIRATORY (INHALATION) 19920918 NDA NDA020118 Baxter Healthcare Corporation DESFLURANE 240 mL/240mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 10019-644_c897e830-83b1-4920-a19f-98349acf0b91 10019-644 HUMAN PRESCRIPTION DRUG Suprane DESFLURANE LIQUID RESPIRATORY (INHALATION) 19920918 NDA NDA020118 Baxter Healthcare Corporation DESFLURANE 240 mL/240mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 10019-646_cd79a147-ba96-40b8-87a6-4ee5942012e0 10019-646 HUMAN PRESCRIPTION DRUG SUPRANE DESFLURANE LIQUID RESPIRATORY (INHALATION) 19920918 NDA NDA020118 Baxter Healthcare Corporation DESFLURANE 240 mL/240mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 10019-648_c9cf5e72-5b34-4ed4-9fe0-fda76921fd89 10019-648 HUMAN PRESCRIPTION DRUG azithromycin azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19970101 NDA AUTHORIZED GENERIC NDA050733 Baxter Healthcare Corporation AZITHROMYCIN DIHYDRATE 100 mg/mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 10019-651_9a00c3c1-ed6a-4e4e-a1f8-13c3483fea9c 10019-651 HUMAN PRESCRIPTION DRUG Sevoflurane Sevoflurane LIQUID RESPIRATORY (INHALATION) 20020702 ANDA ANDA075895 Baxter Healthcare Corporation SEVOFLURANE 250 mL/250mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 10019-653_f674c714-4253-4bef-b30e-242d78bdb533 10019-653 HUMAN PRESCRIPTION DRUG SEVOFLURANE Sevoflurane LIQUID RESPIRATORY (INHALATION) 20020707 ANDA ANDA075895 Baxter Healthcare Corporation SEVOFLURANE 250 mL/250mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 10019-925_b439664d-6a47-42ff-87af-9f409281852b 10019-925 HUMAN PRESCRIPTION DRUG IFOSFAMIDE IFOSFAMIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19881230 NDA NDA019763 Baxter Healthcare Corporation IFOSFAMIDE 1 g/20mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-926_b439664d-6a47-42ff-87af-9f409281852b 10019-926 HUMAN PRESCRIPTION DRUG IFOSFAMIDE IFOSFAMIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19881230 NDA NDA019763 Baxter Healthcare Corporation IFOSFAMIDE 3 g/60mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-935_0a2772a2-ebba-4872-93c6-72a48f3c258d 10019-935 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 500 mg/25mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-936_0a2772a2-ebba-4872-93c6-72a48f3c258d 10019-936 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 1 g/50mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-937_0a2772a2-ebba-4872-93c6-72a48f3c258d 10019-937 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 2 g/100mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-938_1d1bb7ca-dd54-4126-8c4c-9a30b3d7cf50 10019-938 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 500 mg/25mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-939_1d1bb7ca-dd54-4126-8c4c-9a30b3d7cf50 10019-939 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 1 g/50mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-942_1d1bb7ca-dd54-4126-8c4c-9a30b3d7cf50 10019-942 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 2 g/100mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-943_4c96bf67-0915-4a74-a849-a7d8888ad10d 10019-943 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 500 mg/25mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-944_4c96bf67-0915-4a74-a849-a7d8888ad10d 10019-944 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 1 g/50mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-945_4c96bf67-0915-4a74-a849-a7d8888ad10d 10019-945 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 2 g/100mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-953_1b78dcff-5f4e-4d38-b0e9-33fedacbceb8 10019-953 HUMAN PRESCRIPTION DRUG MESNA MESNA INJECTION, SOLUTION INTRAVENOUS 19881230 NDA NDA019884 Baxter Healthcare Corporation MESNA 100 mg/mL Cytoprotective Agent [EPC] N 20181231 10019-955_f05f65fe-79f4-490c-8b2f-f903a85b5eb1 10019-955 HUMAN PRESCRIPTION DRUG Cyclophosphamide cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 500 mg/25mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-956_f05f65fe-79f4-490c-8b2f-f903a85b5eb1 10019-956 HUMAN PRESCRIPTION DRUG Cyclophosphamide cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 1 g/50mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-957_f05f65fe-79f4-490c-8b2f-f903a85b5eb1 10019-957 HUMAN PRESCRIPTION DRUG Cyclophosphamide cyclophosphamide INJECTION, POWDER, FOR SOLUTION INTRAVENOUS; ORAL 20080521 ANDA ANDA040745 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 2 g/100mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-988_4ca23a64-94b0-4317-b647-37dd263c8ea8 10019-988 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE Cyclophosphamide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; ORAL 19591116 NDA NDA012142 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 500 mg/25mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-989_4ca23a64-94b0-4317-b647-37dd263c8ea8 10019-989 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE Cyclophosphamide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; ORAL 19591116 NDA NDA012142 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 1 g/50mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10019-990_4ca23a64-94b0-4317-b647-37dd263c8ea8 10019-990 HUMAN PRESCRIPTION DRUG CYCLOPHOSPHAMIDE Cyclophosphamide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; ORAL 19591116 NDA NDA012142 Baxter Healthcare Corporation CYCLOPHOSPHAMIDE 2 g/100mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 10031-001_3fcaf604-b944-11e4-e054-00144ff8d46c 10031-001 HUMAN OTC DRUG medpak(TM) Derma Guard ZINC OXIDE OINTMENT TOPICAL 20161026 OTC MONOGRAPH FINAL part347 Elba, Inc. ZINC OXIDE 9.6 g/100g N 20181231 10031-006_617d6f4f-97f8-12ae-e053-2991aa0ad247 10031-006 HUMAN OTC DRUG Diaprex ZINC OXIDE CREAM TOPICAL 20170215 OTC MONOGRAPH FINAL part347 Elba, Inc. ZINC OXIDE 96 mg/g N 20181231 10031-008_4b2a349b-93bc-5ef5-e054-00144ff8d46c 10031-008 HUMAN OTC DRUG MedPak Peroxide Oral Rinse HYDROGEN PEROXIDE LIQUID ORAL 20170318 OTC MONOGRAPH NOT FINAL part356 Elba, Inc. HYDROGEN PEROXIDE 15 mg/mL N 20181231 10031-010_567bf60a-eff7-703d-e054-00144ff8d46c 10031-010 HUMAN OTC DRUG MedPak Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20170811 OTC MONOGRAPH NOT FINAL part333E Elba, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 10031-011_567c559f-9c1f-0b35-e054-00144ff8d46c 10031-011 HUMAN OTC DRUG MedPak Derma Guard ZINC OXIDE OINTMENT TOPICAL 20170811 OTC MONOGRAPH FINAL part347 Elba, Inc. ZINC OXIDE 96 mg/g N 20181231 10031-015_61f45fe6-8a56-7ade-e053-2a91aa0a46b5 10031-015 HUMAN OTC DRUG Diaprex ZINC OXIDE OINTMENT TOPICAL 20180104 OTC MONOGRAPH FINAL part347 Elba, Inc. ZINC OXIDE; PETROLATUM 9.6; 67.6 g/100g; g/100g N 20191231 10038-250_b009a672-63ac-45f5-93ea-1a251e03dcde 10038-250 HUMAN OTC DRUG Ambix First Aid DYCLONINE HYDROCHLORIDE and Phenol CREAM TOPICAL 20130822 OTC MONOGRAPH NOT FINAL part333A Organics Corporation of America dba Ambix Laboratories DYCLONINE HYDROCHLORIDE; PHENOL .005; .005 g/g; g/g N 20181231 10056-004_4be3cd9b-7bc8-334e-e054-00144ff8d46c 10056-004 HUMAN OTC DRUG Tolsom Skin Protective SPF 15 Sunscreen OCTINOXATE, OXYBENZONE, OCTISALATE LOTION TOPICAL 20170328 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC OCTINOXATE; OXYBENZONE; OCTISALATE 75; 40; 48 mg/mL; mg/mL; mg/mL N 20181231 10056-005_61ce8dd4-1e8e-0e8f-e053-2991aa0af391 10056-005 HUMAN OTC DRUG Artistry Essentials Hand Treatment AVOBENZONE, OCTINOXATE CREAM TOPICAL 20170328 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC AVOBENZONE; OCTINOXATE 30; 75 mg/mL; mg/mL N 20191231 10056-006_61ce8dd4-1e9d-0e8f-e053-2991aa0af391 10056-006 HUMAN OTC DRUG Satinique Anti Dandruff PYRITHIONE ZINC CREAM TOPICAL 20170329 OTC MONOGRAPH FINAL part358H Access Business Group LLC PYRITHIONE ZINC 95 mg/mL N 20191231 10056-007_61ceb7b5-8404-1166-e053-2a91aa0a3982 10056-007 HUMAN OTC DRUG Essential By Artistry Anti Acne Treatment SALICYLIC ACID GEL TOPICAL 20170329 OTC MONOGRAPH FINAL part358H Access Business Group LLC SALICYLIC ACID 10 mg/mL N 20191231 10056-008_61ceb6f4-3e90-4675-e053-2991aa0a086e 10056-008 HUMAN OTC DRUG Essential by Artistry Anti Acne Pore Refresher SALICYLIC ACID GEL TOPICAL 20170329 OTC MONOGRAPH FINAL part358H Access Business Group LLC SALICYLIC ACID 50 mg/mL N 20191231 10056-030_61ce33c3-c009-52bf-e053-2a91aa0a1221 10056-030 HUMAN OTC DRUG Artistry Ideal Radiance Illuminating CC SPF50 Broad Spectrum Sunscreen - Light ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20151211 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC ENSULIZOLE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 20; 55; 5; 8.8; 98 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 10056-031_61ceb6f4-3eea-4675-e053-2991aa0a086e 10056-031 HUMAN OTC DRUG G AND H PROTECT DEODORANT AND ANTIPERSPIRANT ROLL ON Aluminum Chlorohydrate LIQUID TOPICAL 20160829 OTC MONOGRAPH FINAL part350 Access Business Group LLC ALUMINUM CHLOROHYDRATE .25 g/mL N 20191231 10056-134_4215a09f-f8ad-409d-b7be-914f08368863 10056-134 HUMAN OTC DRUG Artistry Essentials Anti-Blemish Acne Treatment SALICYLIC ACID LOTION TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part333D Access Business Group SALICYLIC ACID 1.1 mL/100mL E 20171231 10056-135_6a7a09bb-45bb-4b8b-8a73-7279b6756271 10056-135 HUMAN OTC DRUG QuickFlex Menthol CREAM TOPICAL 20100530 OTC MONOGRAPH NOT FINAL part348 Access Business Group International LLC MENTHOL 1.25 g/100g E 20171231 10056-175_618e7c73-400c-767a-e053-2991aa0a640a 10056-175 HUMAN OTC DRUG Body Essentials Hand and Body Moisturizing Formula SPF 8 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC OCTINOXATE; OXYBENZONE 70; 30 mg/mL; mg/mL N 20191231 10056-178_eae04a2e-02b2-4fe2-bbf7-8b73f3b0d09f 10056-178 HUMAN OTC DRUG Body Series Deodorant and Antiperspirant Roll-On Regular Scent ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20110411 OTC MONOGRAPH FINAL part350 Access Business Group, Inc. ALUMINUM CHLOROHYDRATE 25 mL/100mL E 20171231 10056-276_996fdb69-57e0-4b39-8d0c-1a65fbae0f10 10056-276 HUMAN OTC DRUG Body Series Invisible Solid Deodorant and Antiperspirant Clean Scent ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY CREAM TOPICAL 20110405 OTC MONOGRAPH FINAL part350 Access Business Group ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g E 20171231 10056-530_7be2b3d8-c34a-4750-8e04-d19b2f43e60f 10056-530 HUMAN OTC DRUG Glister Multi-Action Fluoride Toothpaste SODIUM FLUORIDE PASTE, DENTIFRICE TOPICAL 20110411 OTC MONOGRAPH FINAL part355 Access Business Group, LLC SODIUM FLUORIDE .21 g/100g E 20171231 10056-700_d05f1836-0df0-41e5-b505-9e928741f012 10056-700 HUMAN OTC DRUG Peter Island Sunscreen SPF 50 OCTOCRYLENE OXYBENZONE ZINC OXIDE LOTION TOPICAL 20121120 OTC MONOGRAPH NOT FINAL part352 ACCESS BUSINESS GROUP INTERNATIONAL LLC OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 2; 3.9 g/100g; g/100g; g/100g N 20181231 10056-701_17e0c695-9b3b-4059-b74b-699f976ebc85 10056-701 HUMAN OTC DRUG Peter Island Continuous Sport Sunscreen SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE SPRAY TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 15; 6; 3; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 10056-702_7538b626-5241-431d-87a9-ee3b90de32d6 10056-702 HUMAN OTC DRUG Peter Island SunscreenSPF 50 SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 13; 4; 3; 5; 7 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 10056-704_e21eeba7-b3f9-44da-90da-9b86ed1e87a3 10056-704 HUMAN OTC DRUG Peter Island Sunscreen SPF 70 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 15; 6; 3; 5; 10 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 10056-705_295f3a7c-6aaa-4590-beb9-2aa29f2149cf 10056-705 HUMAN OTC DRUG Peter Island Sunscreen SPF 30 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 10; 2; 2; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 10056-706_19074ee2-ff90-4503-a321-cda59d247638 10056-706 HUMAN OTC DRUG Peter Island Baby Sunscreen SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 13; 4; 3; 5; 7 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 10056-707_fe852b93-a70b-4af4-a0ee-0860a6279f3b 10056-707 HUMAN OTC DRUG Peter Island Ultimate Sheer Dry Touch Sunscreen SPF 70 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 15; 6; 3; 5; 2.8 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 10056-708_118f62aa-85b4-4032-9ce6-0e5ba6c16414 10056-708 HUMAN OTC DRUG PETER ISLAND NATURAL MINERALSPF 60 SPF 60 TITANIUM DIOXIDE ZINC OXIDE LOTION TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC TITANIUM DIOXIDE; ZINC OXIDE 2.8; 4 g/100g; g/100g N 20181231 10056-709_e24f1373-26a6-4256-a654-418a56a691f2 10056-709 HUMAN OTC DRUG Peter Island Continous sunscreen SPF 50 OXYBENZONE, AVOBENZONE, OCTOCRYLENE SPRAY TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC OXYBENZONE; AVOBENZONE; OCTISALATE 5; 3; 5 g/100g; g/100g; g/100g N 20181231 10056-710_2c389c71-920b-4711-af22-26eb2cd168e3 10056-710 HUMAN OTC DRUG Peter Island Continous sunscreen kids SPF 50 OXYBENZONE, AVOBENZONE, OCTOCRYLENE SPRAY TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC OXYBENZONE; AVOBENZONE; OCTISALATE 5; 3; 5 g/100g; g/100g; g/100g N 20181231 10056-711_54a41877-7106-4442-a228-1afd818ca525 10056-711 HUMAN OTC DRUG Peter Island Continous sunscreen SPF 30 OCTOCRYLENE AVOBENZONE OCTISALATE HOMOSALATE LOTION TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part352 Access Business Group LLC OCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE 10; 3; 5; 10 g/100g; g/100g; g/100g; 1/100g N 20181231 10073-111_4259841b-f118-47ce-9d23-487d20453bfb 10073-111 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 19640101 NDA NDA205767 Oz Arc/gas Equipment & Supply, Inc. OXYGEN 992 mL/L N 20181231 10095-001_898632e8-9d4e-4a68-a5c7-ec62e33ca6ff 10095-001 HUMAN OTC DRUG Anesgerm Benzocaine GEL ORAL 20150430 OTC MONOGRAPH NOT FINAL part356 World Perfumes, Inc BENZOCAINE .2 g/100g E 20171231 10095-002_83cb365a-f757-4aae-bf59-c52a5cf5bd35 10095-002 HUMAN OTC DRUG Artico Ice menthol GEL TOPICAL 20150504 OTC MONOGRAPH NOT FINAL part348 World Perfumes, Inc MENTHOL 1 g/100g E 20171231 10095-003_08aaff6a-1d51-41a6-bec2-072826cf5085 10095-003 HUMAN OTC DRUG Camphor Camphor OINTMENT TOPICAL 20150505 OTC MONOGRAPH NOT FINAL part348 World Perfumes, Inc CAMPHOR (NATURAL) 10 g/100g E 20171231 10095-004_3f2e12a9-ebec-4437-9572-68aaff820287 10095-004 HUMAN OTC DRUG Mercurochrome Benzalkonium Chloride CREAM TOPICAL 20150505 OTC MONOGRAPH NOT FINAL part333A World Perfumes, Inc BENZALKONIUM CHLORIDE .13 g/100g E 20171231 10095-005_4f120502-67fb-46d2-b663-1fe06160c619 10095-005 HUMAN OTC DRUG Merthiolate Benzalkonium Chloride CREAM TOPICAL 20150505 OTC MONOGRAPH NOT FINAL part333A World Perfumes, Inc BENZALKONIUM CHLORIDE .13 g/100g E 20171231 10095-006_165fad22-2a1e-4536-8a7f-ebdba31477de 10095-006 HUMAN OTC DRUG QuitaCallos salicylic acid CREAM TOPICAL 20150505 OTC MONOGRAPH FINAL part358F World Perfumes, Inc SALICYLIC ACID 17 g/100g E 20171231 10095-007_dd0840bd-3c0e-4709-9715-e2f1bb6631fa 10095-007 HUMAN OTC DRUG Sulfur Sulfur OINTMENT TOPICAL 20150505 OTC MONOGRAPH FINAL part333D World Perfumes, Inc SULFUR 10 g/100g E 20171231 10095-008_61c0ee3f-e4e7-4cd5-b5a5-46493efe3b31 10095-008 HUMAN OTC DRUG Verruguin Salicylic Acid GEL TOPICAL 20150505 OTC MONOGRAPH FINAL part358B World Perfumes, Inc SALICYLIC ACID 17 g/100g E 20171231 10096-0004_5f975aeb-016e-4e82-af02-38fa7bc6a7de 10096-0004 HUMAN OTC DRUG foot works arthritis achy foot and muscle Methyl Salicylate CREAM TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part348 New Avon LLC METHYL SALICYLATE 250 mg/mL E 20171231 10096-0038_568ca901-73be-4fef-a1f3-8d0cc004f79e 10096-0038 HUMAN OTC DRUG Beyond Color Plumping Lipcolor OCTINOXATE LIPSTICK TOPICAL 20130209 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE 75 mg/g E 20171231 10096-0071_954c462b-a2ae-4ff7-9c50-92b7d5cc80bd 10096-0071 HUMAN OTC DRUG Skin So Soft Bug Guard Plus IR3535 Cool N Fabulous Disappearing Color Insect Repellent Sunscreen Octinoxate, Oxybenzone, Octisalate LOTION TOPICAL 20130212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OXYBENZONE; OCTISALATE 75; 60; 50 mg/mL; mg/mL; mg/mL E 20171231 10096-0081_e3cb22a4-f35e-422c-a0e5-b995e5d11f82 10096-0081 HUMAN OTC DRUG On Duty Original Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121116 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 207 mg/mL E 20171231 10096-0082_922ebc35-48a9-465a-9b5f-622ee8d926b7 10096-0082 HUMAN OTC DRUG Feelin Fresh Original Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121116 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 207 mg/mL E 20171231 10096-0103_5488b68d-dd86-405c-baa2-6efcc2a3365e 10096-0103 HUMAN OTC DRUG moisture therapy intensive healing and repair lip Octinoxate, Oxybenzone OINTMENT TOPICAL 20120522 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; OXYBENZONE 75; 30 mg/mL; mg/mL E 20171231 10096-0121_3c29d5b3-de93-4d66-9654-14a6a3c3b54a 10096-0121 HUMAN OTC DRUG Skin So Soft Bug Guard Plus IR3535 Expedition Insect Repellent Sunscreen Octocrylene, Octinoxate, Oxybenzone, Octisalate SPRAY TOPICAL 20130212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTOCRYLENE; OCTINOXATE; OXYBENZONE; OCTISALATE 100; 75; 60; 50 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0138_a58da81d-3292-4471-b3a3-39d8a1beee5a 10096-0138 HUMAN OTC DRUG Anew Age-Transforming Concealer Titanium Dioxide, Octinoxate CREAM TOPICAL 20130209 OTC MONOGRAPH NOT FINAL part352 New Avon LLC TITANIUM DIOXIDE; OCTINOXATE 66.2; 25 mg/g; mg/g E 20171231 10096-0144_3bb52643-1d5c-423f-8b4f-b7409f7443b3 10096-0144 HUMAN OTC DRUG mark. For Gooness Face Antioxidant Skin Moisturizing Homosalate, Octinoxate, Octisalate, Oxybenzone, Avobenzone LOTION TOPICAL 20130308 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 80; 75; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0146_2d0a0183-73a9-40a9-87e5-719b6989b434 10096-0146 HUMAN OTC DRUG Moisture Therapy Anti-Itch menthol SPRAY TOPICAL 20120926 OTC MONOGRAPH NOT FINAL part348 Avon Products, Inc. MENTHOL 5 mg/mL E 20171231 10096-0149_59ab0592-cb79-434c-83b5-7e41efac7394 10096-0149 HUMAN OTC DRUG Anew Rejuvenate 24 hour Eye Moisturizer OCTINOXATE, OCTISALATE, AVOBENZONE, HOMOSALATE CREAM TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE; AVOBENZONE; HOMOSALATE 75; 50; 20; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0152_898cc617-e642-4d8f-96f5-0eb4c29b503d 10096-0152 HUMAN OTC DRUG Skin So Soft Bug Guard Plus IR3535 Expedition Insect Repellent Sunscreen Octocrylene, Octinoxate, Oxybenzone, Octisalate AEROSOL TOPICAL 20130212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTOCRYLENE; OCTINOXATE; OXYBENZONE; OCTISALATE 90; 68; 54; 45 mg/g; mg/g; mg/g; mg/g N 20181231 10096-0153_8fd6a82f-087b-4250-9d14-fd2683517241 10096-0153 HUMAN OTC DRUG Skin So Soft Firm and Restore Age Defying Corrective Neck and Chest Octinoxate, Oxybenzone, Octisalate, Avobenzone CREAM TOPICAL 20120417 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE 7.5; 3; 3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 10096-0154_106ec01b-10f1-469e-91db-54c7cd33edeb 10096-0154 HUMAN OTC DRUG Clearskin Professional Daily Correcting Salicylic Acid LOTION TOPICAL 20111109 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 5 mg/mL E 20171231 10096-0155_247a0a14-9f9c-4744-ba38-390ca89f761f 10096-0155 HUMAN OTC DRUG Clearskin Professional Deep Pore Cleansing Scrub Salicylic Acid GEL TOPICAL 20121111 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 5 mg/mL E 20171231 10096-0158_208d37f0-8214-4aa4-88cb-66d7d40d6350 10096-0158 HUMAN OTC DRUG Magix Face Perfector OCTINOXATE, OCTISALATE LOTION TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE 75; 40 mg/mL; mg/mL E 20171231 10096-0168_084a9c9c-d070-4b8a-a5af-cde88b052bf1 10096-0168 HUMAN OTC DRUG Solutions A.M. Total Radiance OCTINOXATE, OCTISALATE, AVOBENZONE LOTION TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE; AVOBENZONE 75; 50; 20 mg/mL; mg/mL; mg/mL E 20171231 10096-0171_9554a117-bcb6-4731-ba4f-f162245e5024 10096-0171 HUMAN OTC DRUG Anew Age-Transforming Foundation Octinoxate, Titanium Dioxide LOTION TOPICAL 20130209 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; TITANIUM DIOXIDE 75; 40 mg/mL; mg/mL E 20171231 10096-0173_9a4aa372-2642-4132-9024-4cdb368fe869 10096-0173 HUMAN OTC DRUG mark. get a tint tinted moisturizer Octinoxate, Titanium Dioxide LOTION TOPICAL 20120523 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; TITANIUM DIOXIDE 2.995; 2.905 mL/50mL; mL/50mL E 20171231 10096-0178_ef0f74ed-7936-4385-ae60-51ab0691f2a6 10096-0178 HUMAN OTC DRUG Solutions Ageless Results Day OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 75; 50; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0180_a36f28b1-d9f7-4020-b43f-18e20902e095 10096-0180 HUMAN OTC DRUG CLEARSKIN PROFESSIONAL INVISIBLE BLEMISH TREATMENT Salicylic Acid GEL TOPICAL 20091210 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID .3 mL/15mL E 20171231 10096-0181_efa124d3-d775-4ddf-b7ff-1be2581d72c0 10096-0181 HUMAN OTC DRUG Anew Reversalist Day Renewal OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20091215 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 71.1; 47.5; 40; 28.5 mg/g; mg/g; mg/g; mg/g E 20171231 10096-0182_7d1304a2-edfb-4187-a6b2-5e618c4882a1 10096-0182 HUMAN OTC DRUG Clearskin Blackhead Eliminating Cleanser Salicylic Acid GEL TOPICAL 20091216 OTC MONOGRAPH FINAL part333D New Avon LLC SALICYLIC ACID 20 mg/mL E 20171231 10096-0183_104763f9-1e49-4be7-8927-300be484023b 10096-0183 HUMAN OTC DRUG Clearskin Blackhead Eliminating Daily Astringent Salicylic Acid LIQUID TOPICAL 20091216 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID 5 mL/250mL E 20171231 10096-0184_a67393dd-273c-486f-83c4-97448020873b 10096-0184 HUMAN OTC DRUG Clearskin Blackhead Eliminating Deep Treatment Mask Salicylic Acid PASTE TOPICAL 20091216 OTC MONOGRAPH FINAL part333D New Avon LLC SALICYLIC ACID 5 mg/mL E 20171231 10096-0185_322f9e62-5cec-4e4e-b97a-73f80e891cd8 10096-0185 HUMAN OTC DRUG Clearskin Professional Oil Free OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE LOTION TOPICAL 20091221 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 71.1; 45; 30; 25 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0186_db8fe33f-1f5a-41d6-8799-1aaf0355ed16 10096-0186 HUMAN OTC DRUG Clearskin Blemish Clearing Acne Pads Salicylic acid LIQUID TOPICAL 20091221 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID 300 mg/30g E 20171231 10096-0188_ae64975b-ac6a-45b7-831c-4c003032bcca 10096-0188 HUMAN OTC DRUG Ultra Color Rich Mega Impact OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20091222 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE 150; 90 mg/3g; mg/3g E 20171231 10096-0189_acb0ee1d-4140-4c73-bba8-0a0dde0e587b 10096-0189 HUMAN OTC DRUG magix Cashmere Finish Liquid Foundation Titanium Dioxide LOTION TOPICAL 20091229 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc TITANIUM DIOXIDE 33.9 mg/mL E 20171231 10096-0191_55c26acc-351a-40d5-b8ab-a80c326a350c 10096-0191 HUMAN OTC DRUG Ultra Color Rich Cool Bliss OCTINOXATE LIPSTICK TOPICAL 20091229 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE 210 mg/3g E 20171231 10096-0192_3c8a938b-ce64-4fd7-a955-be6ca9ab0731 10096-0192 HUMAN OTC DRUG mark. back up plan Anti-Acne Back Treatment Salicylic Acid SPRAY TOPICAL 20091229 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID 4.72 mL/118mL E 20171231 10096-0193_a4b058f6-4452-4d8c-9819-dc10fff61aef 10096-0193 HUMAN OTC DRUG True Force Roll-On Antiperspirant Deoderant Aluminum Chlorohydrate GEL TOPICAL 20091229 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL E 20171231 10096-0194_37626f3a-17af-4bd3-a3d1-b6d42a05c32f 10096-0194 HUMAN OTC DRUG MARK. BLEMISH BANISHER Anti-Acne Body Treatment Pads Salicylic Acid CLOTH TOPICAL 20091229 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID .6 mL/60mL E 20171231 10096-0195_42816e46-aaec-483d-8e12-2a01051bf501 10096-0195 HUMAN OTC DRUG MARK. Break Out Plan Salicylic Acid GEL TOPICAL 20091229 OTC MONOGRAPH FINAL part333 Avon Products Inc. SALICYLIC ACID .75 mL/50mL E 20171231 10096-0196_0180ddf0-a656-48ab-8a05-46d5203f6049 10096-0196 HUMAN OTC DRUG Imari Seduction Roll-On Anti-Perspirant Deoderant Aluminum Chlorohydrate GEL TOPICAL 20091229 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL E 20171231 10096-0199_0c26c839-a5d7-4cd7-82d6-7f4675996daf 10096-0199 HUMAN OTC DRUG Clearskin Pore Penetrating Cleanser TRICLOSAN GEL TOPICAL 20100602 OTC MONOGRAPH NOT FINAL part333 Avon Products, Inc. TRICLOSAN .5 mL/125mL E 20171231 10096-0200_9487022c-0402-42c1-a37e-a3a06944bc2a 10096-0200 HUMAN OTC DRUG Clearskin Blemish Clearing Foaming Cleanser Salicylic acid GEL TOPICAL 20100602 OTC MONOGRAPH FINAL part333D New Avon LLC SALICYLIC ACID 20 mg/mL E 20171231 10096-0201_1a4c6245-bd7f-450d-8d75-b1cbe2974fec 10096-0201 HUMAN OTC DRUG mark Totally Balmed OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE LIPSTICK TOPICAL 20100602 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE 294; 199.5; 199.5; 84 mg/4.2g; mg/4.2g; mg/4.2g; mg/4.2g E 20171231 10096-0203_0f7c7dc1-daf7-4cc0-a875-b26c43056139 10096-0203 HUMAN OTC DRUG mark. save the day Anti-Acne Concealer Salicylic Acid STICK TOPICAL 20100603 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 36 mg/1.8g E 20171231 10096-0206_1d0a0ed5-02f6-4d6d-bfb0-a82f805230fb 10096-0206 HUMAN OTC DRUG Solutions Neck and Chest Perfector OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20100607 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE 75; 30; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0208_390889e2-bfe6-4902-a747-6cc4d9e83c39 10096-0208 HUMAN OTC DRUG Naturals Cucumber and Melon Anti Bacterial Hand TRICLOSAN LIQUID TOPICAL 20100609 OTC MONOGRAPH NOT FINAL part333E New Avon LLC TRICLOSAN 2 mg/mL E 20171231 10096-0209_c3f62feb-a5e0-4e9b-bd5e-b0d3f7b32313 10096-0209 HUMAN OTC DRUG Naturals Pomegranate and Mango Anti-Bacterial Hand TRICLOSAN LIQUID TOPICAL 20100609 OTC MONOGRAPH NOT FINAL part333E New Avon LLC TRICLOSAN 2 mg/mL E 20171231 10096-0210_027fb56e-34df-4fd2-b074-f2aac20c7716 10096-0210 HUMAN OTC DRUG Far Away Dreams Roll-On Antiperspirant Deoderant Aluminum Chlorohydrate GEL TOPICAL 20100609 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL E 20171231 10096-0212_10cbc80c-e5f8-468b-b78a-e6f428eea8ac 10096-0212 HUMAN OTC DRUG Naturals Antibacterial Liquid Soap Vanilla TRICLOSAN LIQUID TOPICAL 20100609 OTC MONOGRAPH NOT FINAL part333 Avon Products, Inc. TRICLOSAN .5 mL/250mL E 20171231 10096-0214_e7e7899a-29af-4410-bfef-a4239477be10 10096-0214 HUMAN OTC DRUG Healthy Makeup Cream-to-Powder Foundation TITANIUM DIOXIDE CREAM TOPICAL 20100609 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. TITANIUM DIOXIDE 765 mg/9g E 20171231 10096-0215_f2550015-df2c-441a-9a5f-be5c70c2a574 10096-0215 HUMAN OTC DRUG Healthy Makeup Lip Conditioner OCTINOXATE LIPSTICK TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE 225 mg/3g E 20171231 10096-0216_8ec212b5-92c1-4bda-8ed9-3f5aa44a7dfe 10096-0216 HUMAN OTC DRUG Healthy Makeup OCTINOXATE LIPSTICK TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE 225 mg/3g E 20171231 10096-0217_2d7176bc-35f2-4365-9bad-1378673c387f 10096-0217 HUMAN OTC DRUG Naturals Vanilla Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20100611 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL E 20171231 10096-0219_6d951e00-c148-40c6-bdd7-296bdf82a247 10096-0219 HUMAN OTC DRUG Naturals Cucumber Melon Anti-perspirant Deoderant Aluminum Chlorohydrate GEL TOPICAL 20100611 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL E 20171231 10096-0220_001f9823-68ce-4dcb-bc55-603e6f1a7c68 10096-0220 HUMAN OTC DRUG Advance Techniques Keep Clear Anti-Dandruff Treatment PYRITHIONE ZINC LOTION TOPICAL 20100611 OTC MONOGRAPH FINAL part358 Avon Products, Inc. PYRITHIONE ZINC .15 mL/150mL E 20171231 10096-0221_92293452-8e03-4327-a710-75e27a780c26 10096-0221 HUMAN OTC DRUG Advance Techniques Keep Clear 2-in-1 Anti-Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20100614 OTC MONOGRAPH FINAL part358H Avon Products, Inc. PYRITHIONE ZINC 10 mg/mL E 20171231 10096-0223_562eb5ea-4da6-4862-bd39-c54ffedbd89e 10096-0223 HUMAN OTC DRUG Clearskin Blemish Clearing Spot Treatment Salicylic acid GEL TOPICAL 20100614 OTC MONOGRAPH FINAL part333 Avon Products, Inc. SALICYLIC ACID .3 mL/15mL E 20171231 10096-0224_dab9e138-7923-484b-9637-3ff050307bc2 10096-0224 HUMAN OTC DRUG ANEW Platinum Day OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20100907 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 75; 47.5; 40; 28.5 mg/g; mg/g; mg/g; mg/g E 20171231 10096-0225_971ff91d-fb30-4fbd-a1dd-2ba36a1c1287 10096-0225 HUMAN OTC DRUG Rare Diamonds Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20100907 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-0226_4a74b611-6d04-4298-a1ae-22b047488f0f 10096-0226 HUMAN OTC DRUG Clearskin Professional Clear Pore Thermal Mask Salicylic acid GEL TOPICAL 20100917 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID .375 mL/75mL E 20171231 10096-0227_5889492c-1505-496f-a7e5-cc2759e30be5 10096-0227 HUMAN OTC DRUG IMARI Mystique Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20100917 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL E 20171231 10096-0228_f292780e-524a-4a00-b306-db9087e7ce83 10096-0228 HUMAN OTC DRUG Moisture Therapy Ultra Skin Renewal Petrolatum OINTMENT TOPICAL 20100917 OTC MONOGRAPH FINAL part347 Avon Products, Inc. PETROLATUM 60.3 mL/100mL E 20171231 10096-0229_acc165fb-a26e-4db6-99d1-b22b776ed04f 10096-0229 HUMAN OTC DRUG Ultra Color Rich Moisture Seduction OCTINOXATE LIPSTICK TOPICAL 20101214 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE .225 g/3g E 20171231 10096-0231_5b393da2-d964-4722-8e37-cf01d8b1e229 10096-0231 HUMAN OTC DRUG Extralasting Cream-to-Powder Foundation OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; TITANIUM DIOXIDE 63.4; 30 mg/g; mg/g E 20171231 10096-0232_767bd3c0-cde1-46fc-854d-12894f168a47 10096-0232 HUMAN OTC DRUG Extralasting Liquid Foundation TITANIUM DIOXIDE LOTION TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part352 New Avon LLC TITANIUM DIOXIDE 53.9 mg/mL E 20171231 10096-0233_ce770504-10b9-4155-a415-570e465b94ad 10096-0233 HUMAN OTC DRUG Musk Marine Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20101215 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-0234_fb5d4ccb-1f32-4cd5-a074-1a0102013e2e 10096-0234 HUMAN OTC DRUG mark. Get Treatment Anti-Acne Overnight Treatment Salicylic Acid GEL TOPICAL 20101216 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID .425 mL/25mL E 20171231 10096-0236_4ba5c6ef-7bcf-4f7a-ae05-e31da847397b 10096-0236 HUMAN OTC DRUG mark. Lipclick SPF 15 Color Shine Octinoxate, Oxybenzone LIPSTICK TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE .15; .09 g/3g; g/3g E 20171231 10096-0237_5f7394a9-b67b-43ec-b132-26d555cab7ce 10096-0237 HUMAN OTC DRUG mark. Help Wanted Anti-Acne Exfoliating Cleanser Salicylic Acid PASTE TOPICAL 20101220 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID .75 mL/150mL E 20171231 10096-0238_220d4af4-4397-4a95-be8d-5dd7f4fd57bf 10096-0238 HUMAN OTC DRUG Mommy Tillia Antibacterial Hand ALCOHOL GEL TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part333E Avon Products, Inc. ALCOHOL 153.34 mL/237mL E 20171231 10096-0241_cf4480fc-662d-40d3-94d4-e1e50559e63a 10096-0241 HUMAN OTC DRUG Anew Solar Advance Eye and Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20101221 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. TITANIUM DIOXIDE; ZINC OXIDE; TITANIUM DIOXIDE; ZINC OXIDE .155; .345; .165; .36 g/5g; g/5g; g/5g; g/5g E 20171231 10096-0242_fe1fdfa1-6cc5-4b17-98f0-5531d1f8ad03 10096-0242 HUMAN OTC DRUG Tiny Tillia ZINC OXIDE CREAM TOPICAL 20110126 OTC MONOGRAPH FINAL part347 Avon Products, Inc. ZINC OXIDE 10 g/100g E 20171231 10096-0243_0be590d9-57e5-4415-ad25-fadd41ad56ce 10096-0243 HUMAN OTC DRUG On Duty 24 Hours Clear Protection Roll-On Anti-Perspirant Deodorant ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE GEL TOPICAL 20110223 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE 105 mg/mL E 20171231 10096-0246_bd3268b4-1a48-44c1-9c54-7eeb98791da1 10096-0246 HUMAN OTC DRUG Skin So Soft Ultra Even Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20110411 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-0249_fb0e485d-e4ce-4d62-b6b2-2454337b11ed 10096-0249 HUMAN OTC DRUG Moisture Therapy Intensive Healing and Repair Body OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 10 mg/mL; mg/mL; mg/mL E 20171231 10096-0250_f3dc62a1-19d7-4f39-96a6-211f14f5fa0b 10096-0250 HUMAN OTC DRUG Clearskin Blemish Clearing Acne Body Wash Salicylic Acid GEL TOPICAL 20110412 OTC MONOGRAPH FINAL part333D New Avon LLC SALICYLIC ACID 20 mg/mL E 20171231 10096-0251_2fe00e0d-e134-4a3d-adce-c8627c1f22cd 10096-0251 HUMAN OTC DRUG Naturals Vanilla Antibacterial Hand Alcohol GEL TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part333E New Avon LLC ALCOHOL 19.428 mL/30mL E 20171231 10096-0252_e6a0e1c1-7f61-4e86-933b-83f89eae93fb 10096-0252 HUMAN OTC DRUG Naturals Pomegranate and Mango Antibacterial Hand Alcohol GEL TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part333E Avon Products, Inc. ALCOHOL 19.428 mL/30mL E 20171231 10096-0253_52bab874-9772-4753-915f-60100e5b8d30 10096-0253 HUMAN OTC DRUG Naturals Cucumber Melon Antibacterial Hand Alcohol GEL TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part333E New Avon LLC ALCOHOL 19.428 mL/30mL E 20171231 10096-0254_f5a972d7-1350-4aa1-bf3d-f677a828886d 10096-0254 HUMAN OTC DRUG ANEW Solar Advance Sunscreen Body Mist HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE SPRAY TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 12; 11.25; 7.125; 7.125; 4.275; 3.84 mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL N 20181231 10096-0255_cfbc6073-9282-4088-ad2c-dfa027e9568c 10096-0255 HUMAN OTC DRUG mark. Get Defensive SPF 15 Eye Octinoxate, Oxybenzone, Octisalate, Avobenzone CREAM TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE 1.125; .45; .45; .3 mL/15mL; mL/15mL; mL/15mL; mL/15mL E 20171231 10096-0257_2626340a-330d-476d-9013-c5518c6a044f 10096-0257 HUMAN OTC DRUG Ideal Flawless Invisible Coverage Liquid Foundation Titantium Dioxide LOTION TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc TITANIUM DIOXIDE 25.8 mg/mL E 20171231 10096-0258_51a7f2c0-fea0-4432-92a4-717f8e9750cb 10096-0258 HUMAN OTC DRUG superSHOCK Liquid Lip Shine OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20110419 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE .525; .315 g/10.5g; g/10.5g E 20171231 10096-0259_1fd95a73-5901-4928-9269-333dee4cb846 10096-0259 HUMAN OTC DRUG Musk Fire Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20110419 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM CHLOROHYDRATE 7.25 mL/50mL E 20171231 10096-0260_df80c035-9e6a-4179-a110-c7d996a4743b 10096-0260 HUMAN OTC DRUG Avon Extralasting Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20110422 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. TITANIUM DIOXIDE; ZINC OXIDE .936; .8232 g/12g; g/12g E 20171231 10096-0261_50030cc2-75cc-4cef-aee9-f8ae31d1da64 10096-0261 HUMAN OTC DRUG Satin Satisfaction Lip Color OCTINOXATE LIPSTICK TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE .28 g/4g E 20171231 10096-0262_28cc6760-6dee-406a-8573-a4b18e07ca84 10096-0262 HUMAN OTC DRUG Avon Care Moisture Replenish Daily Hydrating OCTINOXATE, OXYBENZONE CREAM TOPICAL 20110713 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTINOXATE; OXYBENZONE 75; 35 mg/mL; mg/mL E 20171231 10096-0264_8703eef1-0559-471c-bc70-834965172d13 10096-0264 HUMAN OTC DRUG Clearskin Professional Acne Mark Treatment Salicylic Acid CREAM TOPICAL 20110928 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 1 mL/50mL E 20171231 10096-0265_0e22311b-fc82-4244-b50b-5e6335fe8e41 10096-0265 HUMAN OTC DRUG magiX Illuminating Face Perfector Octisalate, Titanium Dioxide CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. OCTISALATE; TITANIUM DIOXIDE .9; .657 mL/30mL; mL/30mL E 20171231 10096-0266_c9edc5e4-b478-4485-9f95-4c25d44c9720 10096-0266 HUMAN OTC DRUG Anew Ultimate 7S Day HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE 4; 2.5; 2; 1.425 g/50g; g/50g; g/50g; g/50g E 20171231 10096-0267_0f737667-a96e-4df2-8cc6-877da00dc01c 10096-0267 HUMAN OTC DRUG Clearskin Clear Emergency Intensive Treatment Salicylic Acid GEL TOPICAL 20111220 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID .022 mL/1.1mL E 20171231 10096-0268_b4d091e6-c165-4e2f-81cf-c3c2d2e160ac 10096-0268 HUMAN OTC DRUG Far Away Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20120213 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-0269_f4a2bae2-bd9e-4936-bff1-31bf50e2b1dc 10096-0269 HUMAN OTC DRUG Rare Gold Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20120213 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-0270_38222506-fb83-4647-ade3-0a3295c28e28 10096-0270 HUMAN OTC DRUG Rare Pearls Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20120213 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-0271_fb16b3e1-5952-476e-b42d-004a7f081bee 10096-0271 HUMAN OTC DRUG Skin So Soft Soft and Sensual Anti-Perspirant Deodorant ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE GEL TOPICAL 20120402 OTC MONOGRAPH FINAL part350 Avon Products, Inc. ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE 105 mg/mL E 20171231 10096-0272_b85fd11a-637f-44ce-93e8-a3181ee5dede 10096-0272 HUMAN OTC DRUG Foot Works Healthy Antifungal TOLNAFTATE SPRAY TOPICAL 20111219 OTC MONOGRAPH FINAL part333C New Avon LLC TOLNAFTATE 10 mg/mL E 20171231 10096-0273_b104fa60-1672-4201-817e-143dc04b9ed8 10096-0273 HUMAN OTC DRUG Skin So Soft Signature Silk Anti-Perspirant Deodorant aluminum zirconium pentachlorohydrate GEL TOPICAL 20120417 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE 105 mg/mL E 20171231 10096-0274_db98cfa8-bbef-4be7-b0f0-e155680c2c95 10096-0274 HUMAN OTC DRUG Skin So Soft Fresh and Smooth Moisturizing Hair Minimizing Anti-Perspirant Deodorant aluminum zirconium pentachlorohydrate GEL TOPICAL 20120417 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE 105 mg/mL E 20171231 10096-0275_282b8c50-60e0-4fee-9304-d0e59beb2cfb 10096-0275 HUMAN OTC DRUG Skin So Soft Original Anti-Perspirant Deodorant aluminum zirconium pentachlorohydrate GEL TOPICAL 20120417 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM ZIRCONIUM PENTACHLOROHYDRATE 105 mg/mL E 20171231 10096-0276_e55e62c6-811b-4dc8-a62b-5c8ede250f91 10096-0276 HUMAN OTC DRUG clearskin clear emergency instant spot treatment salicylic acid GEL TOPICAL 20120420 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID .3 mL/15mL E 20171231 10096-0277_7a271cc3-7392-4416-b88f-ff9e889118ae 10096-0277 HUMAN OTC DRUG clearskin clear emergency intensive cream cleanser salicylic acid CREAM TOPICAL 20120420 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 1.5 mL/75mL E 20171231 10096-0278_77bf275b-269e-408c-9f86-9fbd822a3e01 10096-0278 HUMAN OTC DRUG clearskin blemish clearing 2-in-1 treatment and hydrator salicylic acid LOTION TOPICAL 20120423 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID .6 mL/30mL E 20171231 10096-0279_1df5d2b6-828d-4dd2-aa9e-9f3a7e6249b4 10096-0279 HUMAN OTC DRUG ideal flawless invisible coverage cream to powder foundation Octinoxate, Titanium Dioxide CREAM TOPICAL 20120423 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; TITANIUM DIOXIDE 63.1; 31.6 mg/g; mg/g E 20171231 10096-0280_1187f950-0c25-474e-8f57-838edd8a90dd 10096-0280 HUMAN OTC DRUG Ironman Glory Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20120522 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-0281_aec97a2d-6d9b-43fd-9548-0d54d488985b 10096-0281 HUMAN OTC DRUG mark got the goods multi-benefit foundation Octinoxate, Titanium Dioxide, Oxybenzone LOTION TOPICAL 20120522 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE 74.9; 26; 20 mg/mL; mg/mL; mg/mL E 20171231 10096-0282_b601fe98-ecf1-47f4-9c80-1a41555d3b48 10096-0282 HUMAN OTC DRUG skin so soft bug guard plusitch relief itch relief menthol SPRAY TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part348 Avon Products, Inc. MENTHOL 5 mg/mL E 20171231 10096-0284_0c53e5c8-9248-445c-84d1-6f904501c67c 10096-0284 HUMAN OTC DRUG Footworks Maximum Strength Cracked Heel Benzalkonium Chloride, Lidocaine CREAM TOPICAL 20121016 OTC MONOGRAPH NOT FINAL part333A New Avon LLC BENZALKONIUM CHLORIDE; LIDOCAINE 1.3; 40 mg/mL; mg/mL E 20171231 10096-0285_439e6c0e-fce9-4fd5-921c-c497e5cfa5cf 10096-0285 HUMAN OTC DRUG Musk Wood Roll-on Anti-perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121017 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-0286_e3f82075-c54f-4ded-ae1b-562849dba2d0 10096-0286 HUMAN OTC DRUG Imari Blossom Roll-on Anti-perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121022 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-0287_6c0dbaa2-b53c-4a73-9e88-fd2630e74814 10096-0287 HUMAN OTC DRUG Black Suede Essential Roll-on Anti-perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121022 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-0288_21dd8408-fcdd-429c-9ef4-f9fc2a10d0b3 10096-0288 HUMAN OTC DRUG Foot Works Achy Foot Massager Pain Relieving Menthol LOTION TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part348 New Avon LLC MENTHOL 13.5 mg/mL E 20171231 10096-0289_1d5b4cb0-0bfb-4dce-bf5a-d29a68b66c5f 10096-0289 HUMAN OTC DRUG Clearskin Pore Penetrating Cooling Toner Salicylic Acid LIQUID TOPICAL 20121106 OTC MONOGRAPH FINAL part333D Avon Products, Inc. SALICYLIC ACID 5 mg/mL E 20171231 10096-0290_f103ab6a-a5a4-4e0d-bd3e-420b0ecc3d7a 10096-0290 HUMAN OTC DRUG Anew Clinical Absolute Even Spot Correcting Hand OCTINOXATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20121111 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; OXYBENZONE; AVOBENZONE 75; 40; 20 mg/g; mg/g; mg/g E 20171231 10096-0291_9baffd63-26a9-4a6e-8e1b-95b02edba76b 10096-0291 HUMAN OTC DRUG Moisture Therapy Daily Skin Defense Body Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130227 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 10 mg/mL; mg/mL; mg/mL E 20171231 10096-0292_4334664a-aeec-48d6-a673-c41d83d86caf 10096-0292 HUMAN OTC DRUG Moisture Therapy Intensive Healing and Repair Skin Protectant Petrolatum OINTMENT TOPICAL 20100917 OTC MONOGRAPH FINAL part347 New Avon LLC PETROLATUM 604 mg/mL E 20171231 10096-0293_8420437c-807f-4298-8737-149a917a438a 10096-0293 HUMAN OTC DRUG Ideal Flawless Beauty Balm Titantium Dioxide CREAM TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part352 New Avon LLC TITANIUM DIOXIDE 54 mg/mL E 20171231 10096-0294_017eb0fc-896b-44a7-998f-d494e7a844e8 10096-0294 HUMAN OTC DRUG Avon Sun Sunscreen Face Homosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene LOTION TOPICAL 20130326 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc HOMOSALATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 95; 60; 47.5; 30; 28 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0295_62b9048a-7373-4a95-af81-2621e4537097 10096-0295 HUMAN OTC DRUG Avon Sun Sunscreen Homosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene LOTION TOPICAL 20130326 OTC MONOGRAPH NOT FINAL part352 New Avon LLC HOMOSALATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 80; 47.5; 47.5; 28; 25 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0296_340b9d54-984a-46d1-ba40-1ad4fc5c6393 10096-0296 HUMAN OTC DRUG Avon Sun Sunscreen Homosalate, Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene AEROSOL, SPRAY TOPICAL 20130326 OTC MONOGRAPH NOT FINAL part352 New Avon LLC HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 80; 75; 47.5; 47.5; 28.5; 25.6 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10096-0297_d3bc70f0-5c34-48a5-bf91-1a1897ba9bb0 10096-0297 HUMAN OTC DRUG Clearskin Pore Penetrating Black Mineral Mask Salicylic Acid PASTE TOPICAL 20130327 OTC MONOGRAPH FINAL part333D New Avon LLC SALICYLIC ACID 5 mg/mL E 20171231 10096-0298_d43b3c91-84e0-44a0-9b88-03e38256b256 10096-0298 HUMAN OTC DRUG mark Glossworks Lip Gloss Octinoxate, Avobenzone, Octisalate LIPSTICK TOPICAL 20130329 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; AVOBENZONE; OCTISALATE 10; 5; 5 mg/g; mg/g; mg/g N 20181231 10096-0299_728237be-b094-4313-a3e4-d6db37c22b0e 10096-0299 HUMAN OTC DRUG Avon Elements Youth-Restoring Anti-Wrinkle Moisture Octinoxate, Octisalate, Oxybenzone, Avobenzone CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 71.2; 47.5; 20; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0300_88ec6d3b-e646-48ff-b6ae-a2f57bb91ab7 10096-0300 HUMAN OTC DRUG Avon Elements Moisture Boost Daily Moisture Octinoxate, Octisalate, Avobenzone CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; OCTISALATE; AVOBENZONE 71.1; 47.5; 20 mg/mL; mg/mL; mg/mL E 20171231 10096-0301_f2f7d55d-0c02-4c0f-b5b8-a9b574cdcf5c 10096-0301 HUMAN OTC DRUG Avon Elements Moisture Boost Daily Moisture Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; OCTISALATE; AVOBENZONE 75; 47.5; 28.5 mg/mL; mg/mL; mg/mL E 20171231 10096-0302_28fe7a74-58e6-4856-849d-b7f641cf283c 10096-0302 HUMAN OTC DRUG Avon Elements Skin Revitalize Instant Radiance Octinoxate, Oxybenzone, Homosalate, Avobenzone LOTION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; OXYBENZONE; HOMOSALATE; AVOBENZONE 75; 35; 30; 25 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0303_67d65ab5-7ea9-4c15-9b12-7ca0cf1b202d 10096-0303 HUMAN OTC DRUG Foot Works Healthy Antifungal TOLNAFTATE POWDER TOPICAL 20130424 OTC MONOGRAPH FINAL part333C New Avon LLC TOLNAFTATE 10 mg/g E 20171231 10096-0304_3150a12f-22f5-4b10-bfda-1e9b6b62b436 10096-0304 HUMAN OTC DRUG Anew Clinical Skinvincible Multi-Shield Avobenzone, Homosalate, Octinoxate, Octocrylene, Oxybenzone LOTION TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part352 New Avon LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 28; 95; 75; 25.6; 47.5 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 10096-0305_05085a6a-6871-42c8-a09d-9daa66b996fc 10096-0305 HUMAN OTC DRUG Anew Rejuvenate Day Revitalizing OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20130209 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 75; 50; 47.5; 30 mg/g; mg/g; mg/g; mg/g E 20171231 10096-0306_9e466f01-ca92-4baf-a8e8-88d3a94d8993 10096-0306 HUMAN OTC DRUG Magix Face Perfector OCTINOXATE, OCTISALATE LOTION TOPICAL 20130530 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; OCTISALATE 75; 40 mg/mL; mg/mL E 20171231 10096-0307_fcf7cf19-76e6-4447-8bda-42413bba5f13 10096-0307 HUMAN OTC DRUG Ideal Flawless CC Color Corrector Homosalate, Octinoxate, Oxybenzone, Titanium Dioxide, Octocrylene CREAM TOPICAL 20130906 OTC MONOGRAPH NOT FINAL part352 New Avon LLC HOMOSALATE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; OCTOCRYLENE 70; 70; 47; 21.5; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0311_163233b0-590c-4e77-a05a-eb8c2376f769 10096-0311 HUMAN OTC DRUG Anew Reversalist Complete Renewal Day Homosalate, Octinoxate, Oxybenzone, Avobenzone LOTION TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 New Avon LLC HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE 80; 50; 40; 28.5 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0312_3f1da342-8974-4def-a769-b0b120cf8863 10096-0312 HUMAN OTC DRUG Anew Reversalist Complete Renewal Day Homosalate, Octinoxate, Oxybenzone, Avobenzone CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 New Avon LLC HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE 70; 70; 40; 28.5 mg/g; mg/g; mg/g; mg/g E 20171231 10096-0313_d7c8a380-8f0e-4334-81b4-5c7303427318 10096-0313 HUMAN OTC DRUG Avon Sun Sport Refresh Sunscreen Homosalate, Oxybenzone, Octisalate, Avobenzone, Octocrylene LOTION TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 New Avon LLC HOMOSALATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 95; 60; 47.5; 30; 28 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0314_149ed356-93cc-4b48-9e6c-c796577c154b 10096-0314 HUMAN OTC DRUG Avon Sun Sport Refresh Sunscreen Homosalate, Octinoxate, Octisalate, Oxybenzone, Avobenzone LOTION TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 New Avon LLC HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 80; 75; 47.5; 45; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0315_a6afbcad-c50f-4836-b6c1-8a694e838e59 10096-0315 HUMAN OTC DRUG Avon Sun Sport Refresh Sunscreen Homosalate, Octinoxate, Oxybenzone, Octisalate, Avobenzone LOTION TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 New Avon LLC HOMOSALATE; OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE 80; 75; 60; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0316_ace216b8-0c37-4564-b7ca-128ff2849ab6 10096-0316 HUMAN OTC DRUG Ideal Flawless Tinted Moisturizer Octinoxate, Titanium Dioxide LOTION TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; TITANIUM DIOXIDE 75; 54 mg/mL; mg/mL E 20171231 10096-0317_56f15d7e-2645-489b-8985-456e44bd7fe0 10096-0317 HUMAN OTC DRUG Skin So Soft DD Body Octisalate, Oxybenzone, Avobenzone, Octocrylene CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 47.5; 40; 28; 25 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0318_1159b9cb-9c60-40a2-a464-cf895bfef5b0 10096-0318 HUMAN OTC DRUG Avon Elements Youth Restoring Multi-Purpose Homosalate, Octinoxate, Oxybenzone, Avobenzone LOTION TOPICAL 20140317 OTC MONOGRAPH NOT FINAL part352 New Avon LLC HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE 80; 50; 40; 29 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0319_341b91e8-d897-4333-8561-481bf28e34ac 10096-0319 HUMAN OTC DRUG Anew Vitale Day Octinoxate, Octisalate, Oxybenzone, Avobenzone CREAM TOPICAL 20140317 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 70; 45; 40; 28 mg/g; mg/g; mg/g; mg/g E 20171231 10096-0320_1208738f-722f-420f-a324-8a819546715b 10096-0320 HUMAN OTC DRUG Clearskin Blackhead Eliminating Daily Astringent Salicylic Acid LIQUID TOPICAL 20140317 OTC MONOGRAPH FINAL part333D New Avon LLC SALICYLIC ACID 20 mg/mL E 20171231 10096-0321_5efc67c4-6bd4-4e4c-90d9-1bcfeef41add 10096-0321 HUMAN OTC DRUG Beyond Color Plumping Lip Conditioner OCTINOXATE LIPSTICK TOPICAL 20140926 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE 75 mg/g E 20171231 10096-0322_85288e77-67f9-470b-a7be-77929a2ee08f 10096-0322 HUMAN OTC DRUG Anew Vitale Day Homosalate, Octinoxate, Oxybenzone, Avobenzone LOTION TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part352 New Avon LLC HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE 80; 50; 40; 28.5 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0323_6ce98dc4-7c18-4e19-8e8c-9c0549715505 10096-0323 HUMAN OTC DRUG Anew Ultimate Day Multi-Performance Homosalate, Octinoxate, Oxybenzone, Avobenzone CREAM TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part352 New Avon LLC HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE 80; 50; 40; 29 mg/g; mg/g; mg/g; mg/g E 20171231 10096-0324_dfccc996-1ddd-4bcc-9677-d19ce5266456 10096-0324 HUMAN OTC DRUG Anew Age-Transforming Foundation Octinoxate, Titanium Dioxide LOTION TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; TITANIUM DIOXIDE 75; 40 mg/mL; mg/mL E 20171231 10096-0325_00b51523-cb2d-4242-aae7-345da33161a3 10096-0325 HUMAN OTC DRUG ultra color absolute Octinoxate LIPSTICK TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE 75 mg/g E 20171231 10096-0326_bccdaff7-2a1e-4890-b3a7-ded2c4701691 10096-0326 HUMAN OTC DRUG Anew Men Daily Moisturizer Avobenzone, Homosalate, Octinoxate, Octocrylene, Oxybenzone LOTION TOPICAL 20150420 OTC MONOGRAPH NOT FINAL part352 New Avon LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 28; 95; 75; 25.6; 47.5 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 10096-0327_8fc875bc-3fbf-4021-ad7d-dbab8a1edd9a 10096-0327 HUMAN OTC DRUG Clearskin Blemish Clearing Overnight Treatment Salicylic Acid CREAM TOPICAL 20150420 OTC MONOGRAPH FINAL part333D New Avon LLC SALICYLIC ACID 20 mg/mL E 20171231 10096-0328_7866327d-4030-423b-b438-bb25fa6d49ff 10096-0328 HUMAN OTC DRUG Beyond Color Lip Conditioner OCTINOXATE LIPSTICK TOPICAL 20150420 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE 75 mg/g E 20171231 10096-0329_30974b3c-5280-4bfc-bd46-b48bc8481f6d 10096-0329 HUMAN OTC DRUG Beyond Color Lipcolor OCTINOXATE LIPSTICK TOPICAL 20150420 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE 75 mg/g E 20171231 10096-0330_293613a3-5a83-4f01-91b6-4900658b3baa 10096-0330 HUMAN OTC DRUG Ideal Flawless Invisible Coverage Liquid Foundation Titantium Dioxide LOTION TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part352 New Avon LLC TITANIUM DIOXIDE 37.4 mg/mL E 20171231 10096-0331_e8d9cbe0-2ed9-436e-a7c9-39bd038f7829 10096-0331 HUMAN OTC DRUG Skin So Soft Firm and Restore Neck and Chest Treatment Octinoxate, Oxybenzone, Octisalate, Avobenzone CREAM TOPICAL 20151218 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE 75; 30; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10096-0868_d7908a25-d0d4-4bf2-b3bc-5af9e9897977 10096-0868 HUMAN OTC DRUG Haiku Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20121114 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-4423_d16052fb-5197-4680-b1fa-6dc03084fc53 10096-4423 HUMAN OTC DRUG Foot Works Cracked Heel Lidocaine, BENZALKONIUM CHLORIDE CREAM TOPICAL 20120530 OTC MONOGRAPH FINAL part348 Avon Products, Inc. LIDOCAINE; BENZALKONIUM CHLORIDE 1; .065 mL/50mL; mL/50mL E 20171231 10096-5214_94767a0b-d968-45e9-8124-45360a31fd43 10096-5214 HUMAN OTC DRUG Cool Confidence Baby Powder Scent Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121111 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 207 mg/mL E 20171231 10096-5218_9e5d21c8-284e-4f06-9423-e6d388ad9aca 10096-5218 HUMAN OTC DRUG On Duty Sport Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121116 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 207 mg/mL E 20171231 10096-5219_075dd70d-c070-4b81-a451-6fc37cfd4222 10096-5219 HUMAN OTC DRUG On Duty Unscented Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121116 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 207 mg/mL E 20171231 10096-7817_1bb188dd-8105-4cdf-b2b9-dea487d79f13 10096-7817 HUMAN OTC DRUG Mesmerize for Men Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20121114 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-8026_2ac69725-5eea-41bf-9d1a-e24651e76f8c 10096-8026 HUMAN OTC DRUG Skin So Soft Bug Guard Plus IR3535 Gentle Breeze Insect Repellent Sunscreen Octinoxate, Oxybenzone, Octisalate LOTION TOPICAL 20130212 OTC MONOGRAPH NOT FINAL part352 Avon Products, Inc OCTINOXATE; OXYBENZONE; OCTISALATE 75; 60; 50 mg/mL; mg/mL; mg/mL E 20171231 10096-8811_bf7ddce3-df77-4b67-aca8-667b00f4e6cf 10096-8811 HUMAN OTC DRUG Cool Confidence Original Scent Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121111 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 207 mg/mL E 20171231 10096-9182_0e80f451-9f09-4943-b63d-ad0fa25b6720 10096-9182 HUMAN OTC DRUG Black Suede Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20110128 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-9298_567458eb-cb20-46c8-8e14-4eba11dcf0a6 10096-9298 HUMAN OTC DRUG Wild Country Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20121114 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-9357_f23b7e56-61f6-4104-b8a8-fbf756c80acb 10096-9357 HUMAN OTC DRUG Sweet Honesty Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121112 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-9360_50745553-fe68-4bc8-84e4-341f49f500ba 10096-9360 HUMAN OTC DRUG Odyssey Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121112 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-9363_7e6d272f-4f4d-492c-aa14-435babd65b41 10096-9363 HUMAN OTC DRUG Candid Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121112 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-9468_be557436-2cac-4c31-be10-b720ec0c7a32 10096-9468 HUMAN OTC DRUG Night Magic Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121112 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-9475_dd80dbb6-d0f9-40e9-8971-fbc8f71e69de 10096-9475 HUMAN OTC DRUG Imari Roll-On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20121114 OTC MONOGRAPH FINAL part350 New Avon LLC ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-9488_71b3b455-5813-4d93-acb0-fd8f80a50730 10096-9488 HUMAN OTC DRUG Timeless Roll-On Anti-Perspirant Deodorant Aluminum Chlorohydrate GEL TOPICAL 20121112 OTC MONOGRAPH FINAL part350 Avon Products, Inc ALUMINUM CHLOROHYDRATE 145 mg/mL E 20171231 10096-9500_639fc95f-d0dd-1f72-e053-2991aa0a703e 10096-9500 HUMAN OTC DRUG Nutra Effects Radiance Day Cream SPF20 Nutra Effects Radiance Day Cream SPF20 CREAM TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 New Avon LLC OCTINOXATE; OXYBENZONE; HOMOSALATE; AVOBENZONE 7.5; 3.5; 3; 2.5 g/100g; g/100g; g/100g; g/100g N 20191231 10100-117_f5babfb8-9c58-4ece-9bea-34103f864483 10100-117 HUMAN OTC DRUG Lil Goats Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20111216 OTC MONOGRAPH FINAL part347 Canus Vermont LLC ZINC OXIDE 113.6 g/284g E 20171231 10100-119_d49d434c-73fe-42d8-9b06-a3bec3457e5c 10100-119 HUMAN OTC DRUG Lil Goats Zinc Oxide Zinc Oxide CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part347 Canus Vermont LLC ZINC OXIDE; PETROLATUM 40; 49.5 g/142g; g/142g E 20171231 10109-1234_c9c395e1-b240-4d6c-987c-ba42915a6e30 10109-1234 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20040101 UNAPPROVED MEDICAL GAS ACS Medical LLC OXYGEN 99 L/100L E 20171231 10122-141_966dcb73-29d5-4119-ba97-3298e384b83a 10122-141 HUMAN PRESCRIPTION DRUG Retavase reteplase KIT 19961030 BLA BLA103786 Chiesi USA, Inc. N 20181231 10122-143_966dcb73-29d5-4119-ba97-3298e384b83a 10122-143 HUMAN PRESCRIPTION DRUG Retavase reteplase KIT 19961030 BLA BLA103786 Chiesi USA, Inc. N 20181231 10122-313_6ebcdeb5-6d83-4f0e-97b2-016cd30b6c9d 10122-313 HUMAN PRESCRIPTION DRUG Cardene IV nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 19920130 NDA NDA019734 Chiesi USA, Inc. NICARDIPINE HYDROCHLORIDE .1 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 10122-314_6ebcdeb5-6d83-4f0e-97b2-016cd30b6c9d 10122-314 HUMAN PRESCRIPTION DRUG Cardene IV nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 19920130 NDA NDA019734 Chiesi USA, Inc. NICARDIPINE HYDROCHLORIDE .1 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 10122-325_18149071-f37a-4f8e-956d-a243b308680e 10122-325 HUMAN PRESCRIPTION DRUG Cardene IV nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 19920130 NDA NDA019734 Chiesi USA, Inc. NICARDIPINE HYDROCHLORIDE .2 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 10122-326_18149071-f37a-4f8e-956d-a243b308680e 10122-326 HUMAN PRESCRIPTION DRUG Cardene IV nicardipine hydrochloride INJECTION, SOLUTION INTRAVENOUS 19920130 NDA NDA019734 Chiesi USA, Inc. NICARDIPINE HYDROCHLORIDE .2 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 10122-510_7877d4dd-0042-4fb6-b467-dfd4f0d4e31e 10122-510 HUMAN PRESCRIPTION DRUG Curosurf poractant alfa SUSPENSION ENDOTRACHEAL 19991118 NDA NDA020744 Chiesi USA, Inc. PORACTANT ALFA 80 mg/mL Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfactant Activity [MoA] N 20181231 10122-610_448009fa-7a43-4902-8ebb-d569754f9378 10122-610 HUMAN PRESCRIPTION DRUG Cleviprex clevipidine EMULSION INTRAVENOUS 20080915 NDA NDA022156 Chiesi USA, Inc. CLEVIDIPINE .5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 10122-611_448009fa-7a43-4902-8ebb-d569754f9378 10122-611 HUMAN PRESCRIPTION DRUG Cleviprex clevipidine EMULSION INTRAVENOUS 20080915 NDA NDA022156 Chiesi USA, Inc. CLEVIDIPINE .5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 10122-612_448009fa-7a43-4902-8ebb-d569754f9378 10122-612 HUMAN PRESCRIPTION DRUG Cleviprex clevipidine EMULSION INTRAVENOUS 20080915 NDA NDA022156 Chiesi USA, Inc. CLEVIDIPINE .5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 10122-620_17ff4f7d-5a56-4086-ad85-09918cce3dd0 10122-620 HUMAN PRESCRIPTION DRUG KENGREAL cangrelor INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150708 NDA NDA204958 Chiesi USA, Inc. CANGRELOR 50 mg/1 P2Y12 Platelet Inhibitor [EPC],Decreased Platelet Aggregation [PE],P2Y12 Receptor Antagonists [MoA] N 20181231 10122-820_76030f93-09fc-43b6-b86c-6f710bc9c922 10122-820 HUMAN PRESCRIPTION DRUG BETHKIS tobramycin SOLUTION RESPIRATORY (INHALATION) 20130415 NDA NDA201820 Chiesi USA, Inc. TOBRAMYCIN 300 mg/4mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 10122-901_2ca0eba1-1472-455f-95d2-d96cf271565e 10122-901 HUMAN PRESCRIPTION DRUG ZYFLO zileuton TABLET ORAL 19961206 NDA NDA020471 Chiesi USA, Inc. ZILEUTON 600 mg/1 5-Lipoxygenase Inhibitor [EPC],5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE] N 20181231 10122-902_73d2e42b-eba3-40fa-b1f8-2159cf49e41a 10122-902 HUMAN PRESCRIPTION DRUG ZYFLO CR zileuton TABLET, MULTILAYER, EXTENDED RELEASE ORAL 20070530 NDA NDA022052 Chiesi USA, Inc. ZILEUTON 600 mg/1 5-Lipoxygenase Inhibitor [EPC],5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE] N 20181231 10129-033_6284e1fe-be34-69bf-e053-2991aa0a90ab 10129-033 HUMAN OTC DRUG GingiCaine Gel, Pina Colada GingiCaine Gel, Pina Colada Flavor GEL DENTAL; ORAL; PERIODONTAL 19930706 OTC MONOGRAPH NOT FINAL part356 Gingi-Pak a Division of the Belport BENZOCAINE 200 mg/1 N 20191231 10129-034_6285c4f2-c13a-49a9-e053-2991aa0a2b03 10129-034 HUMAN OTC DRUG GingiCaine Gel, Chocolate Mint GingiCaine Gel, Chocolate Mint Flavor GEL DENTAL; ORAL; PERIODONTAL 19930706 OTC MONOGRAPH NOT FINAL part356 Gingi-Pak a Division of the Belport BENZOCAINE 200 mg/1 N 20191231 10129-035_62857d06-a82a-4efa-e053-2991aa0a6d15 10129-035 HUMAN OTC DRUG GingiCaine Gel GingiCaine Gel Banana flavor GEL DENTAL; ORAL; PERIODONTAL 19930706 OTC MONOGRAPH NOT FINAL part356 Gingi-Pak a Division of the Belport BENZOCAINE 200 mg/1 N 20191231 10129-036_6379213e-67fc-9650-e053-2991aa0a04ba 10129-036 HUMAN OTC DRUG Gingicaine Gel Strawberry Gingicaine Gel Strawberry Flavor GEL DENTAL; ORAL; PERIODONTAL 19930706 OTC MONOGRAPH NOT FINAL part356 Gingi-Pak a Division of the Belport BENZOCAINE 200 mg/1 N 20191231 10129-037_628515a5-1760-ac2c-e053-2991aa0a19ce 10129-037 HUMAN OTC DRUG GingiCaine Gel, Cotton Candy Flavor GingiCaine Gel, Cotton Candy Flavor GEL DENTAL; ORAL; PERIODONTAL 19930326 OTC MONOGRAPH NOT FINAL part356 Gingi-Pak a Division of the Belport BENZOCAINE 200 mg/1 N 20191231 10129-059_638dbc25-481e-3d56-e053-2a91aa0a9554 10129-059 HUMAN OTC DRUG Gingi-Aid MAX Z-Twist 00 Gingi-Aid MAX Z-Twist 00 SOLUTION DENTAL; ORAL; PERIODONTAL; SUBGINGIVAL 19950113 OTC MONOGRAPH FINAL part347 Gingi-Pak a Division of the Belport ALUMINUM SULFATE 54 mg/1 N 20191231 10129-060_638dbc25-481e-3d56-e053-2a91aa0a9554 10129-060 HUMAN OTC DRUG Gingi-Aid MAX Z-Twist 1 Gingi-Aid MAX Z-Twist 1 SOLUTION DENTAL; ORAL; PERIODONTAL; SUBGINGIVAL 19950113 OTC MONOGRAPH FINAL part347 Gingi-Pak a Division of the Belport ALUMINUM SULFATE 54 mg/1 N 20191231 10129-061_638dbc25-481e-3d56-e053-2a91aa0a9554 10129-061 HUMAN OTC DRUG Gingi-Aid MAX Z-Twist 2 Gingi-Aid MAX Z-Twist 2 SOLUTION DENTAL; ORAL; PERIODONTAL; SUBGINGIVAL 19950113 OTC MONOGRAPH FINAL part347 Gingi-Pak a Division of the Belport ALUMINUM SULFATE 54 mg/1 N 20191231 10129-062_638dbc25-481e-3d56-e053-2a91aa0a9554 10129-062 HUMAN OTC DRUG Gingi-Aid MAX Z-Twist 3 Gingi-Aid MAX Z-Twist 3 SOLUTION DENTAL; ORAL; PERIODONTAL; SUBGINGIVAL 19980731 OTC MONOGRAPH FINAL part347 Gingi-Pak a Division of the Belport ALUMINUM SULFATE 54 mg/1 N 20191231 10129-063_6285fe10-08bb-8044-e053-2991aa0a8e8b 10129-063 HUMAN OTC DRUG GingiCaine Gel, Mint Julep GingiCaine Gel, Mint Julep Flabvor GEL DENTAL; ORAL; PERIODONTAL 19980713 OTC MONOGRAPH NOT FINAL part356 Gingi-Pak a Division of the Belport BENZOCAINE 200 mg/1 N 20191231 10129-070_62ed4ff3-18f7-5c67-e053-2991aa0a7792 10129-070 HUMAN OTC DRUG Gingicaine Gel Variety Pak Gingicaine Gel Variety Pak GEL DENTAL; ORAL; PERIODONTAL 20140609 OTC MONOGRAPH NOT FINAL part356 Gingi-Pak a Division of the Belport BENZOCAINE 200 mg/1 N 20191231 10129-715_6274d92e-c4ea-34fd-e053-2991aa0ae604 10129-715 HUMAN OTC DRUG GingiCaine gel, Cherry Gingicaine Gel, Cherry flavor GEL DENTAL; ORAL; PERIODONTAL 19990621 OTC MONOGRAPH NOT FINAL part356 Gingi-Pak a Division of the Belport BENZOCAINE 200 mg/1 N 20191231 10129-720_6285d8ce-e484-289a-e053-2991aa0a42a7 10129-720 HUMAN OTC DRUG GingiCaine Liquid, Cherry GingiCaine Liquid, Cherry flavor LIQUID DENTAL; ORAL; PERIODONTAL 19990719 OTC MONOGRAPH NOT FINAL part356 Gingi-Pak a Division of the Belport BENZOCAINE 200 mg/1 N 20191231 10135-106_33298615-aa50-40d5-8be9-9ba7db16e0b8 10135-106 HUMAN OTC DRUG Isopropyl Alcohol 70 Percent isopropyl alcohol LIQUID TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part333A Marlex Pharmaceuticals Inc ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 10135-146_215c89fd-d1a0-4b06-b403-09ea5fdf214e 10135-146 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate sodium polystyrene sulfonate POWDER, FOR SUSPENSION ORAL; RECTAL 20160301 ANDA ANDA204071 Marlex Pharmaceuticals Inc SODIUM POLYSTYRENE SULFONATE 4.1 meq/g E 20171231 10135-152_43084792-7000-4264-818a-d0d0036a8b2c 10135-152 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 19970101 OTC MONOGRAPH NOT FINAL part343 Marlex Pharmaceuticals Inc ACETAMINOPHEN 500 mg/1 E 20171231 10135-182_0710a2b4-2148-4550-a961-83247573896f 10135-182 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20160201 ANDA ANDA204418 Marlex Pharmaceuticals Inc FOLIC ACID 1 mg/1 E 20171231 10135-492_e44a7e8d-c493-46cd-b2cd-fd515a62fda5 10135-492 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20070401 UNAPPROVED DRUG OTHER Marlex Pharmaceuticals Inc SALSALATE 500 mg/1 E 20171231 10135-493_e44a7e8d-c493-46cd-b2cd-fd515a62fda5 10135-493 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20070401 UNAPPROVED DRUG OTHER Marlex Pharmaceuticals Inc SALSALATE 750 mg/1 E 20171231 10135-495_3e129796-33ec-4744-954a-299f89fa1685 10135-495 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride promethazine hydrochloride TABLET ORAL 20161001 ANDA ANDA091179 Marlex Pharmaceuticals Inc PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 10135-516_399efa61-e065-4cd0-a328-8fde48741122 10135-516 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20150401 ANDA ANDA040704 Marlex Pharmaceuticals Inc BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] E 20171231 10135-517_399efa61-e065-4cd0-a328-8fde48741122 10135-517 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20150401 ANDA ANDA040678 Marlex Pharmaceuticals Inc BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] E 20171231 10135-518_399efa61-e065-4cd0-a328-8fde48741122 10135-518 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20150401 ANDA ANDA040677 Marlex Pharmaceuticals Inc BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] E 20171231 10135-522_e8f1288c-c57c-49a1-b143-bf754ab957c8 10135-522 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20150501 ANDA ANDA084903 Marlex Pharmaceuticals Inc PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 10135-524_6fc90578-2c9f-43a7-9c05-a6bc8adc859f 10135-524 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20170915 ANDA ANDA078552 Marlex Pharmaceuticals Inc AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 10135-525_6fc90578-2c9f-43a7-9c05-a6bc8adc859f 10135-525 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20170915 ANDA ANDA078552 Marlex Pharmaceuticals Inc AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 10135-526_6fc90578-2c9f-43a7-9c05-a6bc8adc859f 10135-526 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20170915 ANDA ANDA078552 Marlex Pharmaceuticals Inc AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 10135-532_5dfc1af4-fc19-4d35-9c44-b3381d2d603c 10135-532 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20141201 ANDA ANDA078220 Marlex Pharmaceuticals Inc BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 10135-533_5dfc1af4-fc19-4d35-9c44-b3381d2d603c 10135-533 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20141201 ANDA ANDA077241 Marlex Pharmaceuticals Inc BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 10135-540_e8f1288c-c57c-49a1-b143-bf754ab957c8 10135-540 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20150501 ANDA ANDA084903 Marlex Pharmaceuticals Inc PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 10135-541_3c246752-b856-470e-80c2-34731d535cec 10135-541 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 19760729 ANDA ANDA080966 Marlex Pharmaceuticals Inc PROBENECID 500 mg/1 N 20181231 10135-543_445ce602-e08a-4b6d-abfb-9e7f51ff711a 10135-543 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20141001 ANDA ANDA079082 Marlex Pharmaceuticals Inc URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] E 20171231 10135-567_d8b3a1fb-87c6-45f8-ad6b-58046ecf9eb6 10135-567 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE Acetazolamide TABLET ORAL 20141001 ANDA ANDA084840 Marlex Pharmaceuticals Inc ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] E 20171231 10135-569_252ab443-71b1-442b-b990-73794cec49f4 10135-569 HUMAN PRESCRIPTION DRUG Clindamycin Palmitate Hydrochloride Clindamycin Palmitate Hydrochloride SOLUTION ORAL 20150801 ANDA ANDA203513 Marlex Pharmaceuticals Inc CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 10135-579_80f88338-59e8-48fa-aa41-484d951d9deb 10135-579 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20141001 ANDA ANDA077152 Marlex Pharmaceuticals Inc TERBUTALINE SULFATE 2.5 mg/1 N 20181231 10135-580_80f88338-59e8-48fa-aa41-484d951d9deb 10135-580 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20141001 ANDA ANDA077152 Marlex Pharmaceuticals Inc TERBUTALINE SULFATE 5 mg/1 N 20181231 10135-581_07f22797-b1c9-417f-901f-9fe40e09d109 10135-581 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20141001 ANDA ANDA201407 Marlex Pharmaceuticals Inc TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 10135-584_f8a56779-f03a-45a6-a237-7a55a7c149a8 10135-584 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20141001 ANDA ANDA089776 Marlex Pharmaceuticals Inc ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 10135-585_42bcc296-c005-416f-b0ad-2dccc0c8fe46 10135-585 HUMAN PRESCRIPTION DRUG Loxapine Loxapine succinate TABLET ORAL 20141001 ANDA ANDA090695 Marlex Pharmaceuticals Inc LOXAPINE SUCCINATE 5 mg/1 N 20181231 10135-586_42bcc296-c005-416f-b0ad-2dccc0c8fe46 10135-586 HUMAN PRESCRIPTION DRUG Loxapine Loxapine succinate TABLET ORAL 20141001 ANDA ANDA090695 Marlex Pharmaceuticals Inc LOXAPINE SUCCINATE 10 mg/1 N 20181231 10135-587_42bcc296-c005-416f-b0ad-2dccc0c8fe46 10135-587 HUMAN PRESCRIPTION DRUG Loxapine Loxapine succinate TABLET ORAL 20141001 ANDA ANDA090695 Marlex Pharmaceuticals Inc LOXAPINE SUCCINATE 25 mg/1 N 20181231 10135-588_42bcc296-c005-416f-b0ad-2dccc0c8fe46 10135-588 HUMAN PRESCRIPTION DRUG Loxapine Loxapine succinate TABLET ORAL 20141001 ANDA ANDA090695 Marlex Pharmaceuticals Inc LOXAPINE SUCCINATE 50 mg/1 N 20181231 10135-589_a522e84d-00fe-458d-ad94-0c46d9f2ecf1 10135-589 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET, FILM COATED ORAL 20141001 ANDA ANDA077220 Marlex Pharmaceuticals Inc PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 10135-590_a522e84d-00fe-458d-ad94-0c46d9f2ecf1 10135-590 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET, FILM COATED ORAL 20141001 ANDA ANDA077220 Marlex Pharmaceuticals Inc PILOCARPINE HYDROCHLORIDE 7.5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 10135-599_f6d77e99-70a9-442d-be76-c344d4a3856b 10135-599 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20150501 NDA NDA020184 Marlex Pharmaceuticals Inc PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 10135-600_f6d77e99-70a9-442d-be76-c344d4a3856b 10135-600 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20150501 NDA NDA020184 Marlex Pharmaceuticals Inc PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 10135-601_247f89ef-aefa-4eac-bb2c-bc6257880305 10135-601 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20150801 ANDA ANDA201680 Marlex Pharmaceuticals Inc FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 10135-602_247f89ef-aefa-4eac-bb2c-bc6257880305 10135-602 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20150801 ANDA ANDA201680 Marlex Pharmaceuticals Inc FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 10135-603_13643d1e-4b4d-4e27-9726-59cf52269778 10135-603 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20150801 ANDA ANDA040765 Marlex Pharmaceuticals Inc PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 10135-604_e61bc1f4-5263-463f-86b4-5237f679312d 10135-604 HUMAN PRESCRIPTION DRUG Theophylline Theophylline Anhydrous SOLUTION ORAL 20160201 ANDA ANDA091156 Marlex Pharmaceuticals Inc THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 10135-605_66559dc6-afcc-4f79-b94f-6f7fc7333175 10135-605 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine SOLUTION ORAL 20160201 ANDA ANDA203564 Marlex Pharmaceuticals Inc LAMIVUDINE 10 mg/mL Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 10135-609_90d17152-5214-4fa9-af11-e86974412a50 10135-609 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20160201 ANDA ANDA204010 Marlex Pharmaceuticals Inc OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 10135-610_90d17152-5214-4fa9-af11-e86974412a50 10135-610 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20160201 ANDA ANDA204010 Marlex Pharmaceuticals Inc OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 10135-611_90d17152-5214-4fa9-af11-e86974412a50 10135-611 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20160201 ANDA ANDA204010 Marlex Pharmaceuticals Inc OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 10135-612_33e9a963-426b-48fe-ac2a-34ec6e2151bd 10135-612 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20160201 ANDA ANDA203578 Marlex Pharmaceuticals Inc NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 10135-613_33e9a963-426b-48fe-ac2a-34ec6e2151bd 10135-613 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20160201 ANDA ANDA203578 Marlex Pharmaceuticals Inc NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 10135-614_33e9a963-426b-48fe-ac2a-34ec6e2151bd 10135-614 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20160201 ANDA ANDA203578 Marlex Pharmaceuticals Inc NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 10135-615_ba3e8d2f-b611-4242-9b6b-e0fbc57e64a6 10135-615 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20160301 ANDA ANDA206652 Marlex Pharmaceuticals Inc ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 10135-616_ba3e8d2f-b611-4242-9b6b-e0fbc57e64a6 10135-616 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20160301 ANDA ANDA206652 Marlex Pharmaceuticals Inc ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 10135-620_661b8298-2ec0-4ec0-af74-f05e5e0804e6 10135-620 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, FILM COATED ORAL 20161001 UNAPPROVED DRUG OTHER Marlex Pharmaceuticals Inc PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 10135-621_661b8298-2ec0-4ec0-af74-f05e5e0804e6 10135-621 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, FILM COATED ORAL 20161001 UNAPPROVED DRUG OTHER Marlex Pharmaceuticals Inc PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 10135-622_f8f6572f-2f7c-4dee-a93e-da3c493e16f7 10135-622 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20160701 UNAPPROVED DRUG OTHER Marlex Pharmaceuticals Inc CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] E 20171231 10135-623_57968420-5df5-4b0c-ab16-5bb526a908e5 10135-623 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20160701 ANDA ANDA075541 Marlex Pharmaceuticals Inc BETAXOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10135-624_57968420-5df5-4b0c-ab16-5bb526a908e5 10135-624 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20160701 ANDA ANDA075541 Marlex Pharmaceuticals Inc BETAXOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10135-625_5862ef81-aa7c-4331-96d5-ebc9bc9458d4 10135-625 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20160701 ANDA ANDA065447 Marlex Pharmaceuticals Inc DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 10135-626_5862ef81-aa7c-4331-96d5-ebc9bc9458d4 10135-626 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20160701 ANDA ANDA065447 Marlex Pharmaceuticals Inc DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 10135-628_09ec7682-a3a0-4ca1-a6e8-a55e201fcfb9 10135-628 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine CAPSULE ORAL 20170401 ANDA ANDA207118 Marlex Pharmaceuticals Inc ACETAMINOPHEN; CAFFEINE; BUTALBITAL 300; 40; 50 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 10135-629_6ef27d67-02aa-40af-af68-5053ca6b8a3a 10135-629 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20170501 ANDA ANDA203298 Marlex Pharmaceuticals Inc CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 10135-630_66c709a0-85f5-4c8c-81cf-62bc7752f282 10135-630 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20171020 ANDA ANDA075047 Marlex Pharmaceuticals Inc ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 10135-631_66c709a0-85f5-4c8c-81cf-62bc7752f282 10135-631 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20171020 ANDA ANDA075047 Marlex Pharmaceuticals Inc ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 10135-632_c9329297-281a-48fc-a372-b24facbe1c32 10135-632 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20171020 ANDA ANDA040682 Marlex Pharmaceuticals Inc BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 10135-633_e08aad68-e943-4f29-8f61-ae760954eae0 10135-633 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20171228 ANDA ANDA078384 Marlex Pharmaceuticals Inc CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 10135-634_e08aad68-e943-4f29-8f61-ae760954eae0 10135-634 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20171228 ANDA ANDA078384 Marlex Pharmaceuticals Inc CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 10135-635_e08aad68-e943-4f29-8f61-ae760954eae0 10135-635 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20171228 ANDA ANDA078384 Marlex Pharmaceuticals Inc CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 10135-636_931e979e-ca0f-4a7f-a735-ea37286def27 10135-636 HUMAN PRESCRIPTION DRUG Acamprosate Calcium Acamprosate Calcium TABLET, DELAYED RELEASE ORAL 20160801 ANDA ANDA202229 Marlex Pharmaceuticals Inc ACAMPROSATE CALCIUM 333 mg/1 N 20181231 10135-637_e08aad68-e943-4f29-8f61-ae760954eae0 10135-637 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20171228 ANDA ANDA078384 Marlex Pharmaceuticals Inc CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 10135-638_c3f0f666-fe8d-4350-875e-b00783fa3f03 10135-638 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20180101 ANDA ANDA207555 Marlex Pharmaceuticals Inc CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20191231 10139-321_e77d77f3-3e96-4ff3-a42d-8bd67dfcf58b 10139-321 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride KIT 20091027 ANDA ANDA090299 GeneraMedix Inc. E 20171231 10139-705_2c833457-0409-4fb8-9363-d465bc5ee2fe 10139-705 HUMAN PRESCRIPTION DRUG Ibutilide Fumarate Ibutilide Fumarate INJECTION, SOLUTION INTRAVENOUS 20100112 ANDA ANDA090924 GeneraMedix Inc. IBUTILIDE FUMARATE .1 mg/mL Antiarrhythmic [EPC] E 20171231 10144-427_5a970cb6-fb01-1f85-e053-2a91aa0a4608 10144-427 HUMAN PRESCRIPTION DRUG AMPYRA Dalfampridine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100301 NDA NDA022250 Acorda Therapeutics, Inc. DALFAMPRIDINE 10 mg/1 Potassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA] N 20181231 10144-594_53060d47-c2ff-4066-e054-00144ff8d46c 10144-594 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride TABLET ORAL 19970101 NDA NDA020397 Acorda Therapeutics, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 10144-602_53060d47-c2ff-4066-e054-00144ff8d46c 10144-602 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL 20050404 NDA NDA021447 Acorda Therapeutics, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 10144-604_53060d47-c2ff-4066-e054-00144ff8d46c 10144-604 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL 20050404 NDA NDA021447 Acorda Therapeutics, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 10144-606_53060d47-c2ff-4066-e054-00144ff8d46c 10144-606 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL 20050404 NDA NDA021447 Acorda Therapeutics, Inc. TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 10144-928_004a7b0e-8564-4f7b-b7bb-13ff5ef72af8 10144-928 HUMAN PRESCRIPTION DRUG Qutenza capsaicin KIT 20130812 NDA NDA022395 Acorda Therapeutics, Inc. N 20181231 10144-929_004a7b0e-8564-4f7b-b7bb-13ff5ef72af8 10144-929 HUMAN PRESCRIPTION DRUG Qutenza capsaicin KIT 20130812 NDA NDA022395 Acorda Therapeutics, Inc. N 20181231 10147-0750_0872fc93-fe3c-4be8-9d87-16dd26fb940f 10147-0750 HUMAN PRESCRIPTION DRUG KETOCONAZOLE ketoconazole SHAMPOO TOPICAL 20050701 NDA AUTHORIZED GENERIC NDA019927 Patriot Pharmaceuticals, LLC KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 10147-0761_9eaa0056-756d-4de4-918c-55a3b08d89db 10147-0761 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 19990626 NDA NDA020897 Patriot Pharmaceuticals, LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 10147-0771_9eaa0056-756d-4de4-918c-55a3b08d89db 10147-0771 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 19990626 NDA NDA020897 Patriot Pharmaceuticals, LLC OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 10147-0781_9eaa0056-756d-4de4-918c-55a3b08d89db 10147-0781 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 19990626 NDA NDA020897 Patriot Pharmaceuticals, LLC OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 10147-0881_2f115eec-4211-43a6-97c1-9b618c40aa9a 10147-0881 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide TABLET, FILM COATED ORAL 20010228 NDA NDA021169 Patriot Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 10147-0882_2f115eec-4211-43a6-97c1-9b618c40aa9a 10147-0882 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide TABLET, FILM COATED ORAL 20010228 NDA NDA021169 Patriot Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 10147-0883_2f115eec-4211-43a6-97c1-9b618c40aa9a 10147-0883 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide TABLET, FILM COATED ORAL 20010228 NDA NDA021169 Patriot Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 10147-0891_2f115eec-4211-43a6-97c1-9b618c40aa9a 10147-0891 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20041222 NDA NDA021615 Patriot Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 10147-0892_2f115eec-4211-43a6-97c1-9b618c40aa9a 10147-0892 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20041222 NDA NDA021615 Patriot Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 10147-0893_2f115eec-4211-43a6-97c1-9b618c40aa9a 10147-0893 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20041222 NDA NDA021615 Patriot Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 10147-0901_d2af68e8-c7e8-4adb-b1d9-6f25f32aba8a 10147-0901 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060116 NDA AUTHORIZED GENERIC NDA021692 Patriot Pharmaceuticals, LLC TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 10147-0902_d2af68e8-c7e8-4adb-b1d9-6f25f32aba8a 10147-0902 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060116 NDA AUTHORIZED GENERIC NDA021692 Patriot Pharmaceuticals, LLC TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 10147-0903_d2af68e8-c7e8-4adb-b1d9-6f25f32aba8a 10147-0903 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060116 NDA AUTHORIZED GENERIC NDA021692 Patriot Pharmaceuticals, LLC TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 10147-0911_5631dac4-9dc5-42bb-9fa0-ee800208ce2b 10147-0911 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol INJECTION INTRAMUSCULAR 20110629 NDA AUTHORIZED GENERIC NDA015923 Patriot Pharmaceuticals LLC HALOPERIDOL 5 mg/mL Typical Antipsychotic [EPC] N 20191231 10147-0921_68326e70-45ca-4ace-ada9-0fb50b590212 10147-0921 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20110617 NDA AUTHORIZED GENERIC NDA018701 Patriot Pharmaceuticals LLC HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] N 20191231 10147-0922_68326e70-45ca-4ace-ada9-0fb50b590212 10147-0922 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20110617 NDA AUTHORIZED GENERIC NDA018701 Patriot Pharmaceuticals LLC HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] N 20191231 10147-0951_a1e314bc-7a4c-41fa-83f2-d92c0aedc472 10147-0951 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, EXTENDED RELEASE ORAL 20150924 NDA NDA021999 Patriot Pharmaceuticals, LLC PALIPERIDONE 1.5 mg/1 Atypical Antipsychotic [EPC] N 20191231 10147-0952_a1e314bc-7a4c-41fa-83f2-d92c0aedc472 10147-0952 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, EXTENDED RELEASE ORAL 20150924 NDA NDA021999 Patriot Pharmaceuticals, LLC PALIPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20191231 10147-0953_a1e314bc-7a4c-41fa-83f2-d92c0aedc472 10147-0953 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, EXTENDED RELEASE ORAL 20150924 NDA NDA021999 Patriot Pharmaceuticals, LLC PALIPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] N 20191231 10147-0954_a1e314bc-7a4c-41fa-83f2-d92c0aedc472 10147-0954 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, EXTENDED RELEASE ORAL 20150924 NDA NDA021999 Patriot Pharmaceuticals, LLC PALIPERIDONE 9 mg/1 Atypical Antipsychotic [EPC] N 20191231 10147-0961_707e2788-b375-4bf3-b494-0b4f2929c54e 10147-0961 HUMAN PRESCRIPTION DRUG Almotriptan Malate Almotriptan Malate TABLET, COATED ORAL 20150707 NDA NDA021001 Patriot Pharmaceuticals, LLC ALMOTRIPTAN MALATE 12.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 10147-0962_707e2788-b375-4bf3-b494-0b4f2929c54e 10147-0962 HUMAN PRESCRIPTION DRUG Almotriptan Malate Almotriptan Malate TABLET, COATED ORAL 20150707 NDA NDA021001 Patriot Pharmaceuticals, LLC ALMOTRIPTAN MALATE 6.25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 10147-1700_62108648-9070-4a94-a1a4-25b7aae5461a 10147-1700 HUMAN PRESCRIPTION DRUG itraconazole ITRACONAZOLE CAPSULE ORAL 20050201 NDA NDA020083 Patriot Pharmaceuticals ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 10148-201_ccb0d89e-0258-4244-98e0-2b33b3ac66f0 10148-201 HUMAN PRESCRIPTION DRUG Miglustat miglustat CAPSULE ORAL 20161209 NDA AUTHORIZED GENERIC NDA021348 CoTherix, Inc. MIGLUSTAT 100 mg/1 Glucosylceramide Synthase Inhibitor [EPC],Glucosylceramide Synthase Inhibitors [MoA] N 20181231 10157-1006_d5c84ce1-b166-454e-94af-dddf79b08247 10157-1006 HUMAN OTC DRUG Stridex Maximum Salicylic Acid LIQUID TOPICAL 20121201 OTC MONOGRAPH FINAL part333D Blistex Inc SALICYLIC ACID 2 g/100mL N 20181231 10157-1007_facaed27-a380-4764-9a53-c0279844b22f 10157-1007 HUMAN OTC DRUG Stridex Sensitive Salicylic Acid LIQUID TOPICAL 20121201 OTC MONOGRAPH FINAL part333D Blistex Inc SALICYLIC ACID .5 g/100mL N 20181231 10157-1010_07b69b4f-e710-427e-890f-ff4a3cd3259d 10157-1010 HUMAN OTC DRUG Stridex Essential Salicylic Acid LIQUID TOPICAL 20121201 OTC MONOGRAPH FINAL part333D Blistex Inc SALICYLIC ACID 1 g/100mL N 20181231 10157-1042_d0953407-9274-4f98-af74-c1704a425a7b 10157-1042 HUMAN OTC DRUG Stridex Conditioning Acne Scrub Salicylic Acid GEL TOPICAL 20121231 OTC MONOGRAPH FINAL part333D Blistex Inc SALICYLIC ACID 2 g/100mL E 20171231 10157-1070_eb9d76fe-ae97-4cf4-9efe-95613109df1b 10157-1070 HUMAN OTC DRUG STRIDEX Naturally Clear Stridex naturally clear LIQUID TOPICAL 20091123 OTC MONOGRAPH FINAL part333 Blistex inc SALICYLIC ACID .1 g/1 E 20171231 10157-1100_8b987e1f-1ed5-4a87-99ae-b087bc557624 10157-1100 HUMAN OTC DRUG Blistex Soft and Lush Dimethicone, Octinoxate, and Oxybenzone STICK TOPICAL 20150701 OTC MONOGRAPH FINAL part347 Blistex Inc. DIMETHICONE; OCTINOXATE; OXYBENZONE 2; 6.6; 3 g/100g; g/100g; g/100g N 20181231 10157-1104_313e484f-5360-4433-9589-ad533d2023fa 10157-1104 HUMAN OTC DRUG Blistex Blissful Butters Dimethicone, Octinoxate, and Oxybenzone STICK TOPICAL 20150701 OTC MONOGRAPH FINAL part347 Blistex Inc. DIMETHICONE; OCTINOXATE; OXYBENZONE 2; 6.6; 3 g/100g; g/100g; g/100g N 20181231 10157-1107_43ac8aed-2813-4ee0-8af1-f65ea33480c5 10157-1107 HUMAN OTC DRUG Blistex Five Star Lip Protection Broad Spectrum Dimethicone, Avobenzone, Homosalate, Octinoxate, and Octisalate STICK TOPICAL 20160501 OTC MONOGRAPH FINAL part347 Blistex Inc DIMETHICONE; AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 2; 3; 10; 7.5; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 10157-1108_e9351014-c85c-41c7-aad4-20a7e333d2da 10157-1108 HUMAN OTC DRUG Blistex Deep Renewal Broad Spectrum DIMETHICONE, AVOBENZONE, OCTINOXATE, and OCTISALATE STICK TOPICAL 20160501 OTC MONOGRAPH FINAL part347 Blistex Inc DIMETHICONE; AVOBENZONE; OCTINOXATE; OCTISALATE 2; 3; 6.6; 4.4 g/100g; g/100g; g/100g; g/100g N 20181231 10157-1118_dcca2199-d178-4c5e-b815-f1cac798f776 10157-1118 HUMAN OTC DRUG Blistex Triple Essentials Octinoxate, Octisalate, and Dimethicone STICK TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Blistex Inc OCTINOXATE; OCTISALATE; DIMETHICONE 6.6; 4.4; 2 g/100g; g/100g; g/100g N 20181231 10157-1119_a4ca51de-2dac-4428-856d-2baf2315d661 10157-1119 HUMAN OTC DRUG Blistex Medicated Lip Balm DIMETHICONE, OCTINOXATE, and OCTISALATE STICK TOPICAL 20180115 OTC MONOGRAPH FINAL part347 Blistex Inc DIMETHICONE; OCTINOXATE; OCTISALATE 2; 6.6; 4.4 g/100g; g/100g; g/100g N 20191231 10157-1120_63020956-e6d1-47fc-92c9-4cedf08edc36 10157-1120 HUMAN OTC DRUG Blistex Medicated Mint Balm DIMETHICONE, OCTINOXATE, and OCTISALATE STICK TOPICAL 20180115 OTC MONOGRAPH FINAL part347 Blistex Inc DIMETHICONE; OCTINOXATE; OCTISALATE 2; 6.6; 4.4 g/100g; g/100g; g/100g N 20191231 10157-1121_d2363d10-bfa9-4f53-b36e-cd737eea5e17 10157-1121 HUMAN OTC DRUG Blistex Medicated Berry Balm Dimethicone, Octinoxate, and Octisalate STICK TOPICAL 20180115 OTC MONOGRAPH FINAL part347 Blistex Inc DIMETHICONE; OCTINOXATE; OCTISALATE 2; 6.6; 4.4 g/100g; g/100g; g/100g N 20191231 10157-2100_f6873980-e6b1-4920-b15a-bb7a49ce7e3e 10157-2100 HUMAN OTC DRUG Blistex Ivarest Poison Ivy Itch Zinc Acetate and PRAMOXINE HYDROCHLORIDE SPRAY TOPICAL 20150202 OTC MONOGRAPH FINAL part347 Blistex Inc. ZINC ACETATE; PRAMOXINE HYDROCHLORIDE .12; 1 g/100mL; g/100mL N 20181231 10157-2101_be0c53be-99a3-442f-a3d3-9ffa8b959bd1 10157-2101 HUMAN OTC DRUG Blistex Stridex Spot and T-Zone Acne ClearGel Salicylic Acid GEL TOPICAL 20160104 OTC MONOGRAPH FINAL part333D Blistex Inc SALICYLIC ACID 2 g/100g N 20181231 10157-2103_5c9867e4-1997-4845-addf-dba0e2f41e81 10157-2103 HUMAN OTC DRUG Tucks Medicated Cooling Pads WITCH HAZEL SOLUTION TOPICAL 20160830 OTC MONOGRAPH FINAL part346 Blistex Inc WITCH HAZEL 500 mg/mL N 20181231 10157-3101_770ba925-b4be-4d8d-ab3c-e82f781ba248 10157-3101 HUMAN OTC DRUG Blistex Odor Eaters Medicated Foot MENTHOL, UNSPECIFIED FORM POWDER TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part348 Blistex Inc. MENTHOL, UNSPECIFIED FORM 1 g/100g N 20181231 10157-4645_e629b2da-2c0b-41a4-a45e-780890e07fcf 10157-4645 HUMAN OTC DRUG Blistex Odor-Eaters Powder Tolnaftate SPRAY TOPICAL 20131209 OTC MONOGRAPH FINAL part333C Blistex Inc TOLNAFTATE 1 g/100g N 20181231 10157-8008_c4e81536-9e92-48cf-9e69-8cdf57ec2b37 10157-8008 HUMAN OTC DRUG Blistex Orange Mango Blast Dimethicone, Octinoxate, and Oxybenzone STICK TOPICAL 20140214 OTC MONOGRAPH FINAL part347 Blistex Inc. DIMETHICONE; OCTINOXATE; OXYBENZONE 1; 7.5; 2.5 g/100g; g/100g; g/100g N 20181231 10157-8009_b1492fa2-6f92-4bf8-8270-e5b01d5217af 10157-8009 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20130901 OTC MONOGRAPH FINAL part347 Blistex Inc. N 20181231 10157-8010_7107e665-a422-4711-bd67-01b0d082c5cd 10157-8010 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20130901 OTC MONOGRAPH FINAL part347 Blistex Inc. N 20181231 10157-8012_a883fdbb-b812-4e85-b24f-81e861430683 10157-8012 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20130901 OTC MONOGRAPH FINAL part347 Blistex Inc. N 20181231 10157-8013_e6d98c13-2069-4777-82a0-a92d17ffb466 10157-8013 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20130901 OTC MONOGRAPH FINAL part347 Blistex Inc. N 20181231 10157-8014_8a58af07-0eaa-4522-b8f1-a5ee7ae7d530 10157-8014 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20140701 OTC MONOGRAPH FINAL part347 Blistex Inc. N 20181231 10157-8015_07932d6e-8b02-4207-b680-f0a008693c65 10157-8015 HUMAN OTC DRUG Blistex Ultra Rich Hydration Octinoxate, Oxybenzone, and Dimethicone STICK TOPICAL 20140530 OTC MONOGRAPH FINAL part347 Blistex Inc. OCTINOXATE; OXYBENZONE; DIMETHICONE 6.8; 3; 2 g/100g; g/100g; g/100g N 20181231 10157-8407_8cf7754f-d295-46c3-80c6-5c023e7abbcd 10157-8407 HUMAN OTC DRUG Blistex Lip Medex PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), and PHENOL PASTE TOPICAL 20170328 OTC MONOGRAPH NOT FINAL part348 Blistex Inc. PETROLATUM; MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC); PHENOL 59.14; 1; 1; .6 g/100g; g/100g; g/100g; g/100g N 20181231 10157-9012_c88c222a-c422-45e1-8617-8f938051a1a5 10157-9012 HUMAN OTC DRUG Blistex Ivarest Medicated Poison Ivy Cleansing Foam Menthol SOAP TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part348 Blistex Inc MENTHOL 1 g/100mL E 20171231 10157-9077_10c5d833-2e0b-424e-9bb8-856cf40c3ca0 10157-9077 HUMAN OTC DRUG Ivarest Zinc Oxide, Benzyl Alcohol, and Diphenhydramine Hydrochloride CREAM TOPICAL 20071231 OTC MONOGRAPH FINAL part347 Blistex Inc ZINC OXIDE; BENZYL ALCOHOL; DIPHENHYDRAMINE HYDROCHLORIDE 14; 10.5; 2 g/100g; g/100g; g/100g N 20181231 10157-9302_896d85c5-3190-4ba4-9996-49fd46b1c0a5 10157-9302 HUMAN OTC DRUG Blistex Foille Medicated First Aid Benzocaine and Chloroxylenol OINTMENT TOPICAL 20130305 OTC MONOGRAPH NOT FINAL part348 Blistex Inc. BENZOCAINE; CHLOROXYLENOL 5; .1 g/100g; g/100g N 20181231 10157-9477_8175b23b-e3c5-47c0-867a-38368d2ae84c 10157-9477 HUMAN OTC DRUG Kank-A Mouth Pain Benzocaine LIQUID BUCCAL 20111201 OTC MONOGRAPH FINAL part346 Blistex Inc. BENZOCAINE 200 mg/mL N 20181231 10157-9493_407edd7d-5c54-4120-856b-c6e0e9891a67 10157-9493 HUMAN OTC DRUG KANKA SoftBrush Benzocaine and Zinc Chloride GEL ORAL 20090501 OTC MONOGRAPH NOT FINAL part356 Blistex Inc. BENZOCAINE; ZINC CHLORIDE 20; .1 mL/100g; g/100g N 20181231 10157-9535_5be791fc-5bae-46e8-a7d4-99e84de3a087 10157-9535 HUMAN OTC DRUG Blistex Daily Conditioning Treatment Petrolatum, Octinoxate, and Oxybenzone PASTE TOPICAL 20140214 OTC MONOGRAPH FINAL part347 Blistex Inc. PETROLATUM; OCTINOXATE; OXYBENZONE 54.86; 7.3; 4.5 g/100g; g/100g; g/100g N 20181231 10157-9539_374e1e4e-e5c2-4089-a86c-a86ed39d67c9 10157-9539 HUMAN OTC DRUG Blistex European Formula Lanolin, Octinoxate, and Oxybenzone PASTE TOPICAL 20110701 OTC MONOGRAPH FINAL part352 Blistex Inc. LANOLIN; OCTINOXATE; OXYBENZONE 13; 7.5; 2.5 g/100g; g/100g; g/100g E 20171231 10157-9608_97e6706e-e3cf-4a80-b873-36d61c13ccbb 10157-9608 HUMAN OTC DRUG Blistex Medicated Mint Lip Balm Dimethicone, Oxybenzone, and Padimate O STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part347 Blistex Inc. DIMETHICONE; OXYBENZONE; PADIMATE O 2; 2.5; 6.6 g/100g; g/100g; g/100g N 20181231 10157-9713_0b49344c-a36c-44ed-8ee1-222f6b260f92 10157-9713 HUMAN OTC DRUG Blistex Medicated Berry Balm Dimethicone, Padimate O, and Oxybenzone STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part352 Blistex Inc DIMETHICONE; PADIMATE O; OXYBENZONE 2; 6.6; 2.5 g/100g; g/100g; g/100g N 20181231 10157-9800_dc72ce14-fe53-427a-b293-de9e03c20501 10157-9800 HUMAN OTC DRUG Blistex Raspberry Lemonade Blast Dimethicone, Octinoxate, and Oxybenzone STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part352 Blistex Inc DIMETHICONE; OCTINOXATE; OXYBENZONE 1; 7.5; 2.5 g/100g; g/100g; g/100g N 20181231 10157-9822_377a8067-847a-42cc-b504-2cd07e95a936 10157-9822 HUMAN OTC DRUG Blistex Medicated Lip Balm Dimethicone, Oxybenzone, and Padimate O STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part347 Blistex Inc. DIMETHICONE; OXYBENZONE; PADIMATE O 2; 2.5; 6.6 g/100g; g/100g; g/100g N 20181231 10157-9825_d143602c-e404-4b9d-9401-458a1d395076 10157-9825 HUMAN OTC DRUG Blistex FIVE STAR Lip Protection STICK TOPICAL 20100501 OTC MONOGRAPH FINAL part347 Blistex Inc PETROLATUM; HOMOSALATE; OCTISALATE; OCTINOXATE; OXYBENZONE 30.1; 9.6; 5; 7.5; 5 g/1; g/1; g/1; g/1; g/1 E 20171231 10157-9826_c30bc026-884c-4ded-9798-07390a44cdb9 10157-9826 HUMAN OTC DRUG Blistex Nurture and Nourish Octinoxate, Oxybenzone, and Dimethicone STICK TOPICAL 20130531 OTC MONOGRAPH FINAL part347 Blistex Inc. OCTINOXATE; OXYBENZONE; DIMETHICONE 7.5; 2.5; 2 g/100g; g/100g; g/100g N 20181231 10157-9831_4365e238-9de4-4d27-98ce-c684f33b61bd 10157-9831 HUMAN OTC DRUG Blistex Lip Vibrance Octinoxate, Oxybenzone, and Dimethicone STICK TOPICAL 20130531 OTC MONOGRAPH FINAL part347 Blistex Inc. OCTINOXATE; OXYBENZONE; DIMETHICONE 7.5; 2.5; 2 g/100g; g/100g; g/100g N 20181231 10157-9848_28606dc7-5e71-49ce-84ae-5cc90249c18a 10157-9848 HUMAN OTC DRUG Blistex Revive and Restore Dimethicone, Octinoxate, Oxybenzone, and Lanolin KIT 20110613 OTC MONOGRAPH FINAL part352 Blistex Inc. E 20171231 10157-9858_78ad38e1-bf7d-43dd-8c57-e37864ce7334 10157-9858 HUMAN OTC DRUG Blistex Enhancement Series Dimethicone, Octinoxate, Oxybenzone, Avobenzone, and Octocrylene KIT 20140515 OTC MONOGRAPH FINAL part347 Blistex Inc. N 20181231 10157-9860_20506778-89f2-4641-ab94-a4d9a3744b98 10157-9860 HUMAN OTC DRUG Blistex Cold and Allergy Lip Soother Dimethicone and Pramoxine Hydrochloride STICK TOPICAL 20110701 OTC MONOGRAPH FINAL part347 Blistex Inc DIMETHICONE; PRAMOXINE HYDROCHLORIDE 2; 1 g/100g; g/100g E 20171231 10157-9861_1ca96f35-dd94-4839-8985-76c0fe6b9b38 10157-9861 HUMAN OTC DRUG Blistex Enhancement Series (Lip Vibrance, Deep Renewal and Ultra-Rich Hydration) Dimethicone, Octinoxate, Oxybenzone, Avobenzone, and Octocrylene KIT 20140901 OTC MONOGRAPH FINAL part347 Blistex Inc. N 20181231 10157-9865_0cd06a11-ddec-4cab-91de-086cdbbb1b73 10157-9865 HUMAN OTC DRUG Blistex Enhancement Series (Deep Renewal and Silk and Shine) Avobenzone, Dimethicone, Octinoxate, Octocrylene and Oxybenzone KIT 20150201 OTC MONOGRAPH FINAL part347 Blistex Inc. N 20181231 10157-9866_650478de-15c3-4326-b2f3-1582c4e8a731 10157-9866 HUMAN OTC DRUG Blistex Enhancement Series (Ultra-Rich Hydration and Lip Vibrance) Dimethicone, Octinoxate and Oxybenzone KIT 20150201 OTC MONOGRAPH FINAL part347 Blistex Inc. N 20181231 10157-9867_99cd258c-beda-478e-b99b-75b9f41ffa78 10157-9867 HUMAN OTC DRUG Blistex Enhancement Series (Soft and Lush, Deep Renewal and Ultra-Rich Hydration) Dimethicone, Octinoxate, Oxybenzone, Avobenzone and Octocrylene KIT 20150701 OTC MONOGRAPH FINAL part347 Blistex Inc. N 20181231 10157-9868_efa038bb-8a42-440a-bd74-4351ed77d071 10157-9868 HUMAN OTC DRUG Blistex Herbal Answer Octinoxate, Oxybenzone, and petrolatum STICK TOPICAL 19990601 OTC MONOGRAPH FINAL part347 Blistex Inc. OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 2.5; 43 g/100g; g/100g; g/100g N 20181231 10157-9875_81639730-91a5-4631-8eed-f94dea37d21d 10157-9875 HUMAN OTC DRUG Blistex Lip Massage Blistex Lip Massage GEL TOPICAL 20091215 OTC MONOGRAPH FINAL part352 Blistex Inc PETROLATUM; OCTINOXATE; AVOBENZONE; OCTOCRYLENE; OXYBENZONE 43.33; 7.5; 3; 2.7; 2.5 g/1; g/1; g/1; g/1; g/1 E 20171231 10157-9877_223035cd-996b-4645-9889-4cf8234b93a9 10157-9877 HUMAN OTC DRUG Blistex Complete Moisture Octinoxate, Oxybenzone, and Dimethicone STICK TOPICAL 20030305 OTC MONOGRAPH FINAL part347 Blistex Inc. OCTINOXATE; OXYBENZONE; DIMETHICONE 7.5; 2.5; 2 g/100g; g/100g; g/100g N 20181231 10157-9882_9b06adb6-9147-4183-ae9b-93c1cfb81179 10157-9882 HUMAN OTC DRUG Silk and Shine Dimethicone, Octinoxate, and Oxybenzone STICK TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Blistex Inc DIMETHICONE; OCTINOXATE; OXYBENZONE 2; 7.5; 2.5 g/100g; g/100g; g/100g N 20181231 10157-9883_73563d35-3cbd-49b1-810d-87a09ce849ef 10157-9883 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20130614 OTC MONOGRAPH FINAL part347 Blistex Inc. E 20171231 10157-9883_9c9521cb-2296-4468-8213-ca0a50b6ed1a 10157-9883 HUMAN OTC DRUG Fruit Smoothies Dimethicone, Octinoxate, and Oxybenzone KIT 20120601 OTC MONOGRAPH FINAL part347 Blistex Inc. E 20171231 10157-9951_c5c1e928-a838-4667-9914-438c24bb1a01 10157-9951 HUMAN OTC DRUG Blistex Medicated Dimethicone, Camphor (synthetic), Menthol, and Phenol OINTMENT TOPICAL 20001201 OTC MONOGRAPH NOT FINAL part348 Blistex Inc. DIMETHICONE; CAMPHOR (SYNTHETIC); MENTHOL; PHENOL 1.1; .5; .625; .5 g/100g; g/100g; g/100g; g/100g N 20181231 10157-9955_5ba87baa-5a03-4297-a245-e1d426eda7b4 10157-9955 HUMAN OTC DRUG Moisture Melt Octinoxate, Oxybenzone, and Petrolatum GEL TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Blistex Inc OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 2.5; 31.7 g/100g; g/100g; g/100g N 20181231 10163-0202_1f4aed11-6fbc-4e8a-8363-b4a2334d3233 10163-0202 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040810 UNAPPROVED MEDICAL GAS Quality Home Medical, Inc. OXYGEN 99 L/100L E 20171231 10167-100_43499383-a325-4817-93ae-92c037764233 10167-100 HUMAN PRESCRIPTION DRUG OXYGEN 0XYGEN GAS RESPIRATORY (INHALATION) 19920101 NDA NDA205865 Air Source Industries Inc OXYGEN 99 L/100L N 20181231 10167-200_d11f376d-61f9-4037-be1c-84094d200e70 10167-200 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19920101 NDA NDA206009 Air Source Industries NITROUS OXIDE 99 L/100L N 20191231 10167-300_f43d88bd-7467-4255-9b55-43b7e0e42bb7 10167-300 HUMAN PRESCRIPTION DRUG HELIUM HELIUM GAS RESPIRATORY (INHALATION) 19920101 NDA NDA205843 Air Source Industries Inc HELIUM 99 L/100L N 20181231 10167-400_8bfe8c14-cf53-4610-bdd5-95477b951bc0 10167-400 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19920101 NDA NDA205866 Air Source Industries Inc NITROGEN 99 L/100L N 20181231 10167-500_1bc6da90-1aff-44db-af51-c67f1ba48080 10167-500 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 19920101 NDA NDA205764 Air Source Industries Inc CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 10167-600_229c69ff-9414-498b-86ba-22b6a15ae2cc 10167-600 HUMAN PRESCRIPTION DRUG AIR COMPRESSED AIR COMPRESSED GAS RESPIRATORY (INHALATION) 19920101 NDA NDA205865 Air Source Industries OXYGEN 20 L/100L N 20181231 10189-001_531f9f5e-c53b-4082-a53d-0fc180537704 10189-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19730601 NDA NDA205767 Butler Gas Products Company OXYGEN 990 mL/L N 20181231 10191-1001_1c6d882b-4f2d-2cfb-e054-00144ff88e88 10191-1001 HUMAN PRESCRIPTION DRUG MORPHINUM MORPHINE PELLET SUBLINGUAL 20150722 UNAPPROVED HOMEOPATHIC Remedy Makers ABT-925 ANHYDROUS FREE BASE 3 [hp_X]/1 CII E 20171231 10191-1002_1d858c8b-9798-209b-e054-00144ff8d46c 10191-1002 HUMAN PRESCRIPTION DRUG MORPHINUM MORPHINE PELLET SUBLINGUAL 20150723 UNAPPROVED HOMEOPATHIC Remedy Makers ABT-925 ANHYDROUS FREE BASE 6 [hp_X]/1 CII E 20171231 10191-1003_1d87ae72-46e3-343b-e054-00144ff88e88 10191-1003 HUMAN PRESCRIPTION DRUG MORPHINUM MORPHINE PELLET SUBLINGUAL 20150730 UNAPPROVED HOMEOPATHIC REMEDY MAKERS ABT-925 ANHYDROUS FREE BASE 9 [hp_X]/1 CII E 20171231 10191-1004_1d9a7065-45c3-0e3f-e054-00144ff8d46c 10191-1004 HUMAN PRESCRIPTION DRUG MORPHINUM MORPHINE PELLET SUBLINGUAL 20150803 UNAPPROVED HOMEOPATHIC REMEDY MAKERS ABT-925 ANHYDROUS FREE BASE 12 [hp_X]/1 CII E 20171231 10191-1005_1dac198e-49bc-725b-e054-00144ff8d46c 10191-1005 HUMAN PRESCRIPTION DRUG MORPHINUM MORPHINE PELLET SUBLINGUAL 20150806 UNAPPROVED HOMEOPATHIC REMEDY MAKERS ABT-925 ANHYDROUS FREE BASE 15 [hp_X]/1 CII E 20171231 10191-1013_cab6232e-4cd9-4c73-989e-13a5246869c5 10191-1013 HUMAN PRESCRIPTION DRUG MORPHINUM MORPHINE BASE PELLET SUBLINGUAL 20010427 UNAPPROVED HOMEOPATHIC Remedy Makers MORPHINE 30 [hp_C]/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10191-1029_26d4e1a1-94cf-44b8-b83a-8be26c36376e 10191-1029 HUMAN PRESCRIPTION DRUG Morphinum Muriaticum Morphine Hydrochloride PELLET SUBLINGUAL 20020409 UNAPPROVED HOMEOPATHIC Remedy Makers MORPHINE HYDROCHLORIDE 30 [hp_C]/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10191-1033_1b1625b8-9ebc-4f1a-e054-00144ff8d46c 10191-1033 HUMAN PRESCRIPTION DRUG CODEINUM CODEINE PELLET SUBLINGUAL 20150716 UNAPPROVED HOMEOPATHIC Remedy Makers CODEINE ANHYDROUS 3 [hp_X]/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10191-1034_1a896d55-3108-478c-e054-00144ff88e88 10191-1034 HUMAN PRESCRIPTION DRUG CODEINUM CODEINE PELLET SUBLINGUAL 20150710 UNAPPROVED HOMEOPATHIC Remedy Makers CODEINE ANHYDROUS 6 [hp_X]/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10191-1035_1b04bb5f-aaa5-12ed-e054-00144ff8d46c 10191-1035 HUMAN PRESCRIPTION DRUG CODEINUM CODEINE PELLET SUBLINGUAL 20150714 UNAPPROVED HOMEOPATHIC Remedy Makers CODEINE ANHYDROUS 9 [hp_X]/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10191-1036_1b151ea0-5b6d-1bd1-e054-00144ff88e88 10191-1036 HUMAN PRESCRIPTION DRUG CODEINUM CODEINE PELLET SUBLINGUAL 20150715 UNAPPROVED HOMEOPATHIC Remedy Makers CODEINE ANHYDROUS 12 [hp_X]/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10191-1037_1b175928-adc1-0c5d-e054-00144ff8d46c 10191-1037 HUMAN PRESCRIPTION DRUG CODEINUM CODEINE PELLET SUBLINGUAL 20150716 UNAPPROVED HOMEOPATHIC Remedy Makers CODEINE ANHYDROUS 15 [hp_X]/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10191-1038_1b189bdc-118a-2aca-e054-00144ff8d46c 10191-1038 HUMAN PRESCRIPTION DRUG CODEINUM CODEINE PELLET SUBLINGUAL 20150717 UNAPPROVED HOMEOPATHIC Remedy Makers CODEINE ANHYDROUS 30 [hp_X]/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10191-1045_5028f2db-f788-47d7-9afa-315c37a51cca 10191-1045 HUMAN PRESCRIPTION DRUG CODEINUM CODEINE BASE PELLET SUBLINGUAL 20080423 UNAPPROVED HOMEOPATHIC Remedy Makers CODEINE 100 [hp_C]/1 CII E 20171231 10191-1081_19af6116-0298-3cfb-e054-00144ff8d46c 10191-1081 HUMAN PRESCRIPTION DRUG OPIUM Raw Opium Gum PELLET SUBLINGUAL 20150521 UNAPPROVED HOMEOPATHIC Remedy Makers OPIUM 3 [hp_X]/1 CII E 20171231 10191-1082_19eb9717-94a1-2fd5-e054-00144ff8d46c 10191-1082 HUMAN PRESCRIPTION DRUG OPIUM Raw Opium Gum PELLET SUBLINGUAL 20150706 UNAPPROVED HOMEOPATHIC Remedy Makers OPIUM 6 [hp_X]/1 CII E 20171231 10191-1086_1a61a75c-19ff-462e-e054-00144ff8d46c 10191-1086 HUMAN PRESCRIPTION DRUG OPIUM Raw Opium Gum PELLET SUBLINGUAL 20150708 UNAPPROVED HOMEOPATHIC Remedy Makers OPIUM 30 [hp_X]/1 CII E 20171231 10191-1089_1a7658ae-18ff-0bca-e054-00144ff88e88 10191-1089 HUMAN PRESCRIPTION DRUG OPIUM Raw Opium Gum PELLET SUBLINGUAL 20150709 UNAPPROVED HOMEOPATHIC Remedy Makers OPIUM 6 [hp_C]/1 CII E 20171231 10191-1093_c01f3bdf-9010-4318-9513-a9eeedbaf260 10191-1093 HUMAN PRESCRIPTION DRUG OPIUM RAW OPIUM GUM PELLET SUBLINGUAL 20011121 UNAPPROVED HOMEOPATHIC Remedy Makers OPIUM 30 [hp_C]/1 CII E 20171231 10191-1177_67f493a4-72e1-4c84-8230-ac298d890d12 10191-1177 HUMAN PRESCRIPTION DRUG CHLORALUM CHLORAL HYDRATE PELLET SUBLINGUAL 20000204 UNAPPROVED HOMEOPATHIC Remedy Makers CHLORAL HYDRATE 3 [hp_X]/1 CIV E 20171231 10191-1201_61541ca1-bc53-49d7-9dc8-2e59830df11c 10191-1201 HUMAN OTC DRUG ALLIUM CEPA ONION PELLET SUBLINGUAL 20091216 UNAPPROVED HOMEOPATHIC Remedy Makers ONION 6 [hp_C]/1 E 20171231 10191-1203_82a05dc1-943a-45ea-b6ac-0f32e4693aa9 10191-1203 HUMAN OTC DRUG ALLIUM CEPA ONION PELLET SUBLINGUAL 20030512 UNAPPROVED HOMEOPATHIC Remedy Makers ONION 12 [hp_C]/1 E 20171231 10191-1204_aff8b8b6-ae65-408b-a3ef-a1e5c9e1760d 10191-1204 HUMAN OTC DRUG ALLIUM CEPA ONION PELLET SUBLINGUAL 20040929 UNAPPROVED HOMEOPATHIC Remedy Makers ONION 15 [hp_C]/1 E 20171231 10191-1205_b204f304-8b48-48fb-9484-4bd41c34fbf9 10191-1205 HUMAN OTC DRUG ALLIUM CEPA ONION PELLET SUBLINGUAL 20040811 UNAPPROVED HOMEOPATHIC Remedy Makers ONION 30 [hp_C]/1 E 20171231 10191-1225_1cd90a1d-3598-4430-b7b6-e5406454b2c9 10191-1225 HUMAN PRESCRIPTION DRUG APOMORPHINUM MURIATICUM APOMORPHINE HYDROCHLORIDE PELLET SUBLINGUAL 20020318 UNAPPROVED HOMEOPATHIC Remedy Makers APOMORPHINE HYDROCHLORIDE 3 [hp_X]/1 Dopamine Agonists [MoA],Dopaminergic Agonist [EPC] E 20171231 10191-1242_e0bfd9dc-cb3f-46cf-8ea0-b7293e7fab99 10191-1242 HUMAN OTC DRUG ARNICA MONTANA WHOLE ARNICA PLANT PELLET SUBLINGUAL 20030806 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 6 [hp_X]/1 E 20171231 10191-1243_29feaf50-1b47-4b80-97a5-2cd63f2bf129 10191-1243 HUMAN OTC DRUG ARNICA MONTANA WHOLE ARNICA PLANT PELLET SUBLINGUAL 20080424 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 9 [hp_X]/1 E 20171231 10191-1244_c811fcf9-f8bf-4a2c-bf8a-f43112ebf73c 10191-1244 HUMAN OTC DRUG ARNICA MONTANA WHOLE ARNICA PLANT PELLET SUBLINGUAL 20050328 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 12 [hp_X]/1 E 20171231 10191-1245_3165f866-4839-4d3a-8fb8-ea78d31f7cda 10191-1245 HUMAN OTC DRUG ARNICA MONTANA WHOLE ARNICA PLANT PELLET SUBLINGUAL 20080424 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 15 [hp_X]/1 E 20171231 10191-1246_e424ca5f-bb7e-4a54-8202-7161025b0323 10191-1246 HUMAN OTC DRUG ARNICA MONTANA WHOLE ARNICA PLANT PELLET SUBLINGUAL 20020821 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 30 [hp_X]/1 E 20171231 10191-1248_a4ba17ab-c3b2-473d-8cc0-e78b94858f0b 10191-1248 HUMAN OTC DRUG ARNICA MONTANA ARNICA WHOLE PLANT PELLET SUBLINGUAL 20080424 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 3 [hp_C]/1 E 20171231 10191-1249_78abcbc1-e124-46c1-9402-4c16650a05ef 10191-1249 HUMAN OTC DRUG ARNICA MONTANA WHOLE PLANT (WHOLE PLANT) PELLET SUBLINGUAL 20050824 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 6 [hp_C]/1 E 20171231 10191-1250_0fbe445b-ec09-4695-80de-c6cefbd82e2a 10191-1250 HUMAN OTC DRUG ARNICA MONTANA (WHOLE PLANT) WHOLE ARNICA PLANT PELLET SUBLINGUAL 20050824 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 9 [hp_C]/1 E 20171231 10191-1251_ef8744d8-8e76-4916-aea1-064f51cdc2af 10191-1251 HUMAN OTC DRUG ARNICA MONTANA (WHOLE PLANT) ARNICA WHOLE PLANT PELLET SUBLINGUAL 20030108 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 12 [hp_C]/1 E 20171231 10191-1252_2c4f2489-0baa-408c-a17e-6081755ef4e0 10191-1252 HUMAN OTC DRUG ARNICA MONTANA WHOLE ARNICA PLANT PELLET SUBLINGUAL 20030109 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 150 [hp_C]/1 E 20171231 10191-1253_5e48e261-ef6d-4019-9590-a36fbab3ae03 10191-1253 HUMAN OTC DRUG ARNICA MONTANA WHOLE PLANT WHOLE ARNICA PLANT PELLET SUBLINGUAL 20040706 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 30 [hp_C]/1 E 20171231 10191-1254_1b98a3c1-32ed-4e81-82e3-5ab30736ddc5 10191-1254 HUMAN OTC DRUG ARNICA MONTANA (WHOLE PLANT) ARNICA WHOLE PLANT PELLET SUBLINGUAL 20030109 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 100 [hp_C]/1 E 20171231 10191-1255_5ffbdaa5-43e0-4740-88a7-43a589dcaa8b 10191-1255 HUMAN OTC DRUG ARNICA MONTANA (Whole Plant) ARNICA WHOLE PLANT PELLET SUBLINGUAL 20020821 UNAPPROVED HOMEOPATHIC Remedy Makers ARNICA MONTANA 20 [hp_M]/1 E 20171231 10191-1361_1243c2c1-6a92-4123-8f19-b2af111e71b8 10191-1361 HUMAN OTC DRUG CHAMOMILLA CHAMOMILE PLANT PELLET SUBLINGUAL 20041015 UNAPPROVED HOMEOPATHIC Remedy Makers MATRICARIA RECUTITA 6 [hp_C]/1 E 20171231 10191-1365_15f1cebd-5148-4255-ad63-eaed30cb509c 10191-1365 HUMAN OTC DRUG CHAMOMILLA CHAMOMILLA PLANT PELLET SUBLINGUAL 20050913 UNAPPROVED HOMEOPATHIC Remedy Makers MATRICARIA RECUTITA 30 [hp_C]/1 E 20171231 10191-1411_e7238368-0c10-421a-a99c-84e3851d92cd 10191-1411 HUMAN OTC DRUG CUPRUM METALLICUM COPPER PELLET SUBLINGUAL 20030618 UNAPPROVED HOMEOPATHIC REMEDY MAKERS COPPER 12 [hp_C]/1 E 20171231 10191-1413_9e72b0d3-48b8-4c17-9cdc-1fbfc9a77a4e 10191-1413 HUMAN OTC DRUG CUPRUM METALLICUM COPPER PELLET SUBLINGUAL 20030625 UNAPPROVED HOMEOPATHIC Remedy Makers COPPER 30 [hp_C]/1 E 20171231 10191-1425_747a7374-e139-4c85-8c91-8e023ae0f81d 10191-1425 HUMAN OTC DRUG HYPERICUM PERFORATUM ST JOHNS WORT PELLET SUBLINGUAL 20041015 UNAPPROVED HOMEOPATHIC Remedy Makers HYPERICUM PERFORATUM 6 [hp_C]/1 E 20171231 10191-1429_eafaef57-3e92-4b2f-86d5-55a1408e6684 10191-1429 HUMAN OTC DRUG HYPERICUM PERFORATUM ST JOHNS WORT PELLET SUBLINGUAL 20080416 UNAPPROVED HOMEOPATHIC Remedy Makers HYPERICUM PERFORATUM 30 [hp_C]/1 E 20171231 10191-1445_3be8d685-3dba-4fd8-a68f-61fae50ef834 10191-1445 HUMAN OTC DRUG KALI BICHROMICUM POTASSIUM DICHROMATE PELLET SUBLINGUAL 20030521 UNAPPROVED HOMEOPATHIC Remedy Makers POTASSIUM DICHROMATE 30 [hp_C]/1 E 20171231 10191-1457_841e844b-e071-4fc9-92a6-794a78dff30d 10191-1457 HUMAN OTC DRUG LACHESIS MUTUS BUSHMASTER VENOM PELLET SUBLINGUAL 20061031 UNAPPROVED HOMEOPATHIC REMEDY MAKERS LACHESIS MUTA VENOM 6 [hp_C]/1 E 20171231 10191-1458_c756a2e9-f37f-4c4e-994e-e868e0b2e44a 10191-1458 HUMAN OTC DRUG LACHESIS MUTUS BUSHMASTER VENOM PELLET SUBLINGUAL 20030502 UNAPPROVED HOMEOPATHIC REMEDY MAKERS LACHESIS MUTA VENOM 9 [hp_C]/1 E 20171231 10191-1459_b37faf2d-22b7-4196-a794-0c33cf226a6e 10191-1459 HUMAN OTC DRUG LACHESIS MUTUS BUSHMASTER VENOM PELLET SUBLINGUAL 20030505 UNAPPROVED HOMEOPATHIC REMEDY MAKERS LACHESIS MUTA VENOM 12 [hp_C]/1 E 20171231 10191-1460_bf95049e-7013-4b80-9856-fec85f7e7d9b 10191-1460 HUMAN OTC DRUG LACHESIS MUTUS BUSHMASTER VENOM PELLET SUBLINGUAL 20030507 UNAPPROVED HOMEOPATHIC REMEDY MAKERS LACHESIS MUTA VENOM 15 [hp_C]/1 E 20171231 10191-1461_5c14f901-fe85-4f0d-8fab-2d3e1a6f3b12 10191-1461 HUMAN OTC DRUG LACHESIS MUTUS BUSHMASTER SNAKE VENOM PELLET SUBLINGUAL 19990203 UNAPPROVED HOMEOPATHIC Remedy Makers LACHESIS MUTA VENOM 30 [hp_C]/1 E 20171231 10191-1562_b7b8928d-dc4d-4b20-92fb-a685855114be 10191-1562 HUMAN OTC DRUG SEPIA OFFICINALIS CUTTLEFISH PELLET SUBLINGUAL 20000221 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SEPIA OFFICINALIS JUICE 6 [hp_X]/1 E 20171231 10191-1566_3c2e96aa-70fb-4a33-8509-34c03ac22548 10191-1566 HUMAN OTC DRUG SEPIA OFFICINALIS CUTTLEFISH PELLET SUBLINGUAL 20000221 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SEPIA OFFICINALIS JUICE 30 [hp_X]/1 E 20171231 10191-1569_b04dce81-b665-4370-a101-b36fa43850c4 10191-1569 HUMAN OTC DRUG SEPIA OFFICINALIS CUTTLEFISH PELLET SUBLINGUAL 20030507 UNAPPROVED HOMEOPATHIC Remedy Makers CUTTLEFISH 6 [hp_C]/1 E 20171231 10191-1570_ff12e18c-235a-42fd-8241-e886d0c3e1c4 10191-1570 HUMAN OTC DRUG SEPIA OFFICINALIS CUTTLEFISH PELLET SUBLINGUAL 20040428 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SEPIA OFFICINALIS JUICE 9 [hp_C]/1 E 20171231 10191-1571_47facc8a-4782-402d-ae23-4fa442287240 10191-1571 HUMAN OTC DRUG SEPIA OFFICINALIS CUTTLEFISH PELLET SUBLINGUAL 20030423 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SEPIA OFFICINALIS JUICE 12 [hp_C]/1 E 20171231 10191-1573_5be95f06-5af7-4678-8814-ea88925858ec 10191-1573 HUMAN OTC DRUG SEPIA OFFICINALIS CUTTLEFISH PELLET SUBLINGUAL 20020821 UNAPPROVED HOMEOPATHIC Remedy Makers CUTTLEFISH 30 [hp_C]/1 E 20171231 10191-1578_b47d449e-7bb3-4708-8ece-fd498725f9a7 10191-1578 HUMAN OTC DRUG SULPHUR SULFUR PELLET SUBLINGUAL 19981208 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SULFUR 6 [hp_X]/1 E 20171231 10191-1585_21ccc2d5-c363-443e-9b43-2c5e1ae04e28 10191-1585 HUMAN OTC DRUG SULPHUR SULFUR PELLET SUBLINGUAL 19981215 UNAPPROVED HOMEOPATHIC Remedy Makers SULFUR 6 [hp_C]/1 E 20171231 10191-1587_0d2d80ef-904d-4cf4-8e71-46c0ea48e117 10191-1587 HUMAN OTC DRUG SULPHUR SULFUR PELLET SUBLINGUAL 20030430 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SULFUR 12 [hp_C]/1 E 20171231 10191-1589_63494dd2-60c5-422a-bc8d-dbf498cd16fa 10191-1589 HUMAN OTC DRUG SULPHUR SULFUR PELLET SUBLINGUAL 20020909 UNAPPROVED HOMEOPATHIC Remedy Makers SULFUR 30 [hp_C]/1 E 20171231 10191-1602_08966ee7-b423-4606-826b-0b4858a5f73b 10191-1602 HUMAN OTC DRUG SYMPHYTUM OFFICINALE COMFREY PLANT PELLET SUBLINGUAL 20040204 UNAPPROVED HOMEOPATHIC REMEDY MAKERS COMFREY LEAF 9 [hp_C]/1 E 20171231 10191-1603_07c407e9-1537-402a-8360-95d7c4ec7502 10191-1603 HUMAN OTC DRUG SYMPHYTUM OFFICINALE COMFREY PLANT PELLET SUBLINGUAL 20040204 UNAPPROVED HOMEOPATHIC REMEDY MAKERS COMFREY LEAF 12 [hp_C]/1 E 20171231 10191-1637_48fdb5e3-a586-48c2-b086-6f5c75ba2dd4 10191-1637 HUMAN OTC DRUG MERCURIUS SOLUBILIS SOLUBLE MERCURY PELLET SUBLINGUAL 20011116 UNAPPROVED HOMEOPATHIC Remedy Makers MERCURIUS SOLUBILIS 30 [hp_C]/1 E 20171231 10191-1653_57938a50-32d7-45e6-814b-3afa5e4ce636 10191-1653 HUMAN OTC DRUG CALCAREA CARBONICA CALCIUM CARBONATE PELLET SUBLINGUAL 20040824 UNAPPROVED HOMEOPATHIC Remedy Makers CALCIUM CARBONATE 30 [hp_C]/1 E 20171231 10191-1665_beff73bc-c5b8-4b95-8c8e-2c61a2067cb6 10191-1665 HUMAN OTC DRUG KALI CARBONICUM POTASSIUM CARBONATE PELLET SUBLINGUAL 20111208 UNAPPROVED HOMEOPATHIC REMEDY MAKERS POTASSIUM CARBONATE 6 [hp_C]/1 E 20171231 10191-1714_171c3166-36b7-406d-9de6-bb94d8e89423 10191-1714 HUMAN OTC DRUG HEPAR SULPHURIS CALCAREUM CRUDE CALCIUM SULFIDE PELLET SUBLINGUAL 20030514 UNAPPROVED HOMEOPATHIC REMEDY MAKERS CALCIUM SULFIDE 9 [hp_C]/1 E 20171231 10191-1717_caba5ea3-2a91-4d46-8b40-ae04fd2fa16d 10191-1717 HUMAN OTC DRUG HEPAR SULPHURIS CALCAREUM CRUDE CALCIUM SULFIDE PELLET SUBLINGUAL 20040708 UNAPPROVED HOMEOPATHIC REMEDY MAKERS CALCIUM SULFIDE 30 [hp_C]/1 E 20171231 10191-1761_bcb3aa74-3fad-403c-9caf-7b796a37eaa6 10191-1761 HUMAN OTC DRUG CARBO VEGETABILIS ACTIVATED CHARCOAL PELLET SUBLINGUAL 20100224 UNAPPROVED HOMEOPATHIC Remedy Makers ACTIVATED CHARCOAL 6 [hp_C]/1 E 20171231 10191-1763_ad4f6532-0c31-4fe2-84c2-773a8b1f0657 10191-1763 HUMAN OTC DRUG CARBO VEGETABILIS ACTIVATED CHARCOAL PELLET SUBLINGUAL 20041014 UNAPPROVED HOMEOPATHIC REMEDY MAKERS ACTIVATED CHARCOAL 12 [hp_C]/1 E 20171231 10191-1765_40d22783-eabc-4b99-be58-dad2327bf632 10191-1765 HUMAN OTC DRUG CARBO VEGETABILIS ACTIVATED CHARCOAL PELLET SUBLINGUAL 20020821 UNAPPROVED HOMEOPATHIC Remedy Makers ACTIVATED CHARCOAL 30 [hp_C]/1 E 20171231 10191-1794_d32457a2-8cff-4c4b-9677-cdd4349cf15a 10191-1794 HUMAN OTC DRUG GRAPHITE GRAPHITES PELLET SUBLINGUAL 20040826 UNAPPROVED HOMEOPATHIC REMEDY MAKERS GRAPHITE 9 [hp_C]/1 E 20171231 10191-1795_47579a47-b9fe-40ff-b366-f24ac5fe5d29 10191-1795 HUMAN OTC DRUG GRAPHITES GRAPHITE PELLET SUBLINGUAL 20030514 UNAPPROVED HOMEOPATHIC REMEDY MAKERS GRAPHITE 12 [hp_C]/1 E 20171231 10191-1797_5cca3e35-d449-4dbd-b47f-f6be94098451 10191-1797 HUMAN OTC DRUG GRAPHITES GRAPHITE PELLET SUBLINGUAL 20041014 UNAPPROVED HOMEOPATHIC Remedy Makers GRAPHITE 30 [hp_C]/1 E 20171231 10191-1822_62bd5094-6e66-4e44-bd46-8692cee24304 10191-1822 HUMAN OTC DRUG SILICEA SILICON DIOXIDE PELLET SUBLINGUAL 20040811 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SILICON DIOXIDE 30 [hp_X]/1 E 20171231 10191-1825_6c9df045-2bfb-4347-835e-ad2563e2441a 10191-1825 HUMAN OTC DRUG SILICEA SILICON DIOXIDE PELLET SUBLINGUAL 20040811 UNAPPROVED HOMEOPATHIC Remedy Makers SILICON DIOXIDE 6 [hp_C]/1 E 20171231 10191-1826_90e5ec15-5ed3-4090-8806-b303e751b2c4 10191-1826 HUMAN OTC DRUG SILICEA SILICON DIOXIDE PELLET SUBLINGUAL 20020821 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SILICON DIOXIDE 9 [hp_C]/1 E 20171231 10191-1828_e664b84f-706a-4ff1-a69b-24dcc32e71c2 10191-1828 HUMAN OTC DRUG SILICEA SILICON DIOXIDE PELLET SUBLINGUAL 20030430 UNAPPROVED HOMEOPATHIC REMEDY MAKERS SILICON DIOXIDE 15 [hp_C]/1 E 20171231 10191-1829_c426c8db-eb06-4203-87fa-06ea7c0f0fcf 10191-1829 HUMAN OTC DRUG SILICEA SILICA PELLET SUBLINGUAL 20020821 UNAPPROVED HOMEOPATHIC Remedy Makers SILICON DIOXIDE 30 [hp_C]/1 E 20171231 10191-1841_e952cbaa-1420-49af-8d3c-a05c704c46a9 10191-1841 HUMAN OTC DRUG ANTIMONIUM TARTARICUM ANTIMONY POTASSIUM TARTRATE PELLET SUBLINGUAL 20100106 UNAPPROVED HOMEOPATHIC Remedy Makers ANTIMONY POTASSIUM TARTRATE 6 [hp_C]/1 E 20171231 10191-1842_1c8ee4c3-f0df-4bfe-aa6a-6e6857dfcb44 10191-1842 HUMAN OTC DRUG ANTIMONIUM TARTARICUM Antimony Potassium Tartrate PELLET SUBLINGUAL 20020909 UNAPPROVED HOMEOPATHIC Remedy Makers ANTIMONY POTASSIUM TARTRATE 9 [hp_C]/1 E 20171231 10191-1843_883f3dcd-2714-4d76-82af-24bc6e7e98b3 10191-1843 HUMAN OTC DRUG ANTIMONIUM TARTARICUM ANTIMONY POTASSIUM TARTRATE PELLET SUBLINGUAL 20040929 UNAPPROVED HOMEOPATHIC Remedy Makers ANTIMONY POTASSIUM TARTRATE 12 [hp_C]/1 E 20171231 10191-1844_303af7ac-5b7c-48de-b9a2-a3040f50c965 10191-1844 HUMAN OTC DRUG ANTIMONIUM TARTARICUM ANTIMONY POTASSIUM TARTRATE PELLET SUBLINGUAL 20041011 UNAPPROVED HOMEOPATHIC Remedy Makers ANTIMONY POTASSIUM TARTRATE 15 [hp_C]/1 E 20171231 10191-1845_dd13a759-7821-43e7-b8a5-81ddb86ed320 10191-1845 HUMAN OTC DRUG ANTIMONIUM TARTARICUM ANTIMONY POTASSIUM TARTRATE PELLET SUBLINGUAL 20030423 UNAPPROVED HOMEOPATHIC Remedy Makers ANTIMONY POTASSIUM TARTRATE 30 [hp_C]/1 E 20171231 10191-1857_db300b0e-6a18-4f56-9282-ac61c4e1232a 10191-1857 HUMAN OTC DRUG KALI IODATUM POTASSIUM IODIDE PELLET SUBLINGUAL 20040812 UNAPPROVED HOMEOPATHIC REMEDY MAKERS POTASSIUM IODIDE 6 [hp_C]/1 E 20171231 10191-1873_e0a1b426-94b1-4305-a571-cd778fa310df 10191-1873 HUMAN OTC DRUG CALCAREA FLUORICA CALCIUM FLUORIDE PELLET SUBLINGUAL 20040813 UNAPPROVED HOMEOPATHIC Remedy Makers CALCIUM FLUORIDE 6 [hp_C]/1 E 20171231 10191-1877_23143135-96a1-4c5c-9edf-d930ea4ce278 10191-1877 HUMAN OTC DRUG CALCAREA FLUORICA CALCIUM FLUORIDE PELLET SUBLINGUAL 20080409 UNAPPROVED HOMEOPATHIC Remedy Makers CALCIUM FLUORIDE 30 [hp_C]/1 E 20171231 10191-1889_32006b06-1cb2-4973-b4e8-3487a5537d88 10191-1889 HUMAN OTC DRUG CALCAREA SULPHURICA CALCIUM SULFATE PELLET SUBLINGUAL 20030423 UNAPPROVED HOMEOPATHIC Remedy Makers CALCIUM SULFATE 6 [hp_C]/1 E 20171231 10191-1893_1a46da00-a627-4998-8a2b-1d93958e173c 10191-1893 HUMAN OTC DRUG CALCAREA SULPHURICA CALCIUM SULFATE PELLET SUBLINGUAL 20050728 UNAPPROVED HOMEOPATHIC Remedy Makers CALCIUM SULFATE 30 [hp_C]/1 E 20171231 10191-1905_8ac22923-6867-4a22-8ea7-0bfd666336ed 10191-1905 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERROSOFERRIC PHOSPHATE PELLET SUBLINGUAL 20041014 UNAPPROVED HOMEOPATHIC Remedy Makers FERRUM PHOSPHORICUM 6 [hp_C]/1 E 20171231 10191-1909_38e4050d-3ff6-4653-8508-c66f7fb8693a 10191-1909 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERROSOFERRIC PHOSPHATE PELLET SUBLINGUAL 20040713 UNAPPROVED HOMEOPATHIC Remedy Makers FERRUM PHOSPHORICUM 30 [hp_C]/1 E 20171231 10191-1929_891b6875-6592-4f63-a0b8-f19dbca17ed8 10191-1929 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20040928 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 3 [hp_X]/1 E 20171231 10191-1930_5d0b80b2-46b3-4362-96d3-7693881adf66 10191-1930 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20040928 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 6 [hp_X]/1 E 20171231 10191-1932_a1e43089-21cc-4827-91dc-9d0b1ad2dd20 10191-1932 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20030109 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 12 [hp_X]/1 E 20171231 10191-1934_3719d3a0-da81-4f0a-ab21-2a43156e6846 10191-1934 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20040928 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 30 [hp_X]/1 E 20171231 10191-1937_15bebddc-958c-4ef3-82a5-fd76d7452304 10191-1937 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20040928 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 6 [hp_C]/1 E 20171231 10191-1938_5881ffa6-8e1e-45d5-91c6-d8fd178801d9 10191-1938 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20040928 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 9 [hp_C]/1 E 20171231 10191-1940_c0287ee7-37ed-453f-acb5-ffd596f4c0f7 10191-1940 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20040928 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 15 [hp_C]/1 E 20171231 10191-1941_911e6b31-d62e-4641-b5be-ecf40cc2cf5e 10191-1941 HUMAN OTC DRUG APIS MELLIFICA BEE VENOM PELLET SUBLINGUAL 20050329 UNAPPROVED HOMEOPATHIC Remedy Makers APIS MELLIFERA 30 [hp_C]/1 E 20171231 10191-1973_5ea2ca3b-e142-4f90-be80-00ce41f2f894 10191-1973 HUMAN OTC DRUG MAGNESIA MURIATICA MAGNESIUM CHLORIDE PELLET SUBLINGUAL 20060428 UNAPPROVED HOMEOPATHIC REMEDY MAKERS MAGNESIUM CHLORIDE 30 [hp_C]/1 E 20171231 10191-1989_8027c863-e82c-44a6-8117-72b2c9081277 10191-1989 HUMAN OTC DRUG ARSENICUM ALBUM ARSENIC TRIOXIDE PELLET SUBLINGUAL 20040712 UNAPPROVED HOMEOPATHIC Remedy Makers ARSENIC TRIOXIDE 30 [hp_C]/1 E 20171231 10191-2034_a47a3b8c-fe3d-47d6-9601-9d57b9b8cf6f 10191-2034 HUMAN OTC DRUG LYCOPODIUM CLAVATUM CLUBMOSS PELLET SUBLINGUAL 20030507 UNAPPROVED HOMEOPATHIC REMEDY MAKERS LYCOPODIUM CLAVATUM SPORE 9 [hp_C]/1 E 20171231 10202-020_4984d588-87df-535a-e054-00144ff8d46c 10202-020 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20160728 OTC MONOGRAPH FINAL part341 7-Eleven Inc. MENTHOL 5.4 mg/1 N 20181231 10202-021_562c69ea-e1d9-51de-e054-00144ff8d46c 10202-021 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20150804 OTC MONOGRAPH FINAL part341 7-Eleven Inc. MENTHOL 5.8 mg/1 N 20181231 10202-022_562cc06a-a33e-5d73-e054-00144ff8d46c 10202-022 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20150804 OTC MONOGRAPH FINAL part341 7-Eleven Inc. MENTHOL 7.5 mg/1 N 20181231 10202-050_86957618-6230-4b31-8d3b-74ef6598e85d 10202-050 HUMAN OTC DRUG 7 Select Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, FILM COATED ORAL 20140805 ANDA ANDA079113 7-Eleven DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 10202-056_8de0a039-9d88-4e3e-8e38-6172b4875d41 10202-056 HUMAN OTC DRUG 7 select night time relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140417 OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 10202-085_f3b7863e-bd27-4e16-a16c-04e44bd16055 10202-085 HUMAN OTC DRUG 7-11 Instant Hand Sanitizer With Aloe And Vitamin E ALCOHOL LIQUID TOPICAL 20111102 OTC MONOGRAPH NOT FINAL part333E 7-11 ALCOHOL 62 mL/100mL E 20171231 10202-094_7e4094aa-93e0-4a88-9744-00ce8d97bdbc 10202-094 HUMAN OTC DRUG 7 Select Nasal Decongestant PE Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20161007 OTC MONOGRAPH FINAL part341 7-Eleven PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 10202-100_3fc81cfb-c334-51d3-e054-00144ff8d46c 10202-100 HUMAN OTC DRUG 7 Select Instant Hand Sanitizer with Vitamin E and Moisturizers Alcohol LIQUID TOPICAL 20161014 OTC MONOGRAPH NOT FINAL part333E 7-Eleven Inc ALCOHOL 70 mL/100mL N 20181231 10202-130_95c2456d-93e1-4b08-90b2-b20f33addc5f 10202-130 HUMAN OTC DRUG 7 Select Childrens Pain Relief Acetaminophen SUSPENSION ORAL 20140813 OTC MONOGRAPH NOT FINAL part343 7-Eleven ACETAMINOPHEN 160 mg/5mL N 20181231 10202-186_94383eae-9e0e-4298-a964-842fab1260b2 10202-186 HUMAN OTC DRUG 7 Select Night Time Sleep Aid Diphenhydramine HCl SOLUTION ORAL 20140422 OTC MONOGRAPH FINAL part338 7-Eleven DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 10202-194_67cbf0ac-e7c5-441c-afa4-467363bc43af 10202-194 HUMAN OTC DRUG 7 Select Acid Controller Famotidine TABLET ORAL 20140805 ANDA ANDA077351 7-Eleven FAMOTIDINE 20 mg/1 N 20181231 10202-224_706da376-60af-457e-bb87-d238a20ed358 10202-224 HUMAN OTC DRUG 7 Select Anti Diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20140805 ANDA ANDA075232 7-Eleven LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 10202-259_9b694189-6e16-4814-a797-ce3fb4d41dcd 10202-259 HUMAN OTC DRUG 7 Select Adult Chewable Aspirin Aspirin TABLET, CHEWABLE ORAL 20140805 OTC MONOGRAPH NOT FINAL part343 7-Eleven ASPIRIN 81 mg/1 N 20181231 10202-304_2922d79a-5a3a-4bb0-be0f-9c7cc8a68cf8 10202-304 HUMAN OTC DRUG 7 Select Nasal oxymetazoline hydrochloride SPRAY NASAL 20140805 OTC MONOGRAPH FINAL part341 7-Eleven OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 10202-335_8c148d0f-5805-48df-803a-be6a7848c891 10202-335 HUMAN OTC DRUG 7 select night time relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20140805 OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 10202-337_7577f9e7-b03d-4ae5-8916-c66f0893b075 10202-337 HUMAN OTC DRUG 7 Select Pink Bismuth Bismuth subsalicylate SUSPENSION ORAL 20140417 OTC MONOGRAPH FINAL part335 7-Eleven BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 10202-359_803a218a-25d5-4234-ac5e-d864d8223f6e 10202-359 HUMAN OTC DRUG 7 select Tussin DM Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20160531 OTC MONOGRAPH FINAL part341 7-Eleven DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 10202-374_a17475b8-a4a4-4a2c-afa8-5bd0d797681f 10202-374 HUMAN OTC DRUG 7 Select Migraine Formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20140509 ANDA ANDA075794 7-Eleven ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 10202-379_732d96f9-af1e-4d4d-bcd5-399ca4e336cf 10202-379 HUMAN OTC DRUG 7 select allergy childrens Diphenhydramine HCl SOLUTION ORAL 20140805 OTC MONOGRAPH FINAL part341 7-Eleven DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 10202-416_3c60c115-37d2-44cf-bcb5-7691f8af8867 10202-416 HUMAN OTC DRUG 7 Select Aspirin Aspirin TABLET ORAL 20140805 OTC MONOGRAPH NOT FINAL part343 7-Eleven ASPIRIN 325 mg/1 N 20181231 10202-441_055f8a66-fc42-4ef2-b4b7-bc0f85dc9b24 10202-441 HUMAN OTC DRUG 7 Select Sleep Aid Doxylamine succinate TABLET ORAL 20140805 ANDA ANDA040167 7-Eleven DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 10202-445_1bb1f68b-b1ee-4f18-8542-cc2f2176d353 10202-445 HUMAN OTC DRUG 7 Select Night Time severe cold, cough and flu Acetaminophen, diphenhydramine HCl, phenylephrine HCl POWDER, FOR SOLUTION ORAL 20151112 OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 10202-458_9831decc-17b5-4a3e-82b6-afbe3fc7edbb 10202-458 HUMAN OTC DRUG 7 select all day allergy Cetirizine Hydrochloride TABLET ORAL 20140429 ANDA ANDA078336 7-Eleven CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 10202-479_ad59f81b-77de-41d7-a445-326ddd7fc7d6 10202-479 HUMAN OTC DRUG 7 Select Allergy Diphenhydramine Hydrochloride TABLET ORAL 20140422 OTC MONOGRAPH FINAL part341 7-Eleven DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 10202-484_8434aa89-5cb9-412e-a440-5f79d6684f2e 10202-484 HUMAN OTC DRUG 7 select acetaminophen Acetaminophen TABLET ORAL 20140514 OTC MONOGRAPH NOT FINAL part343 7-Eleven ACETAMINOPHEN 500 mg/1 N 20181231 10202-489_e5d3e74d-c6d5-4ecc-927e-d81b9aac7ece 10202-489 HUMAN OTC DRUG 7 Select Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20140911 OTC MONOGRAPH FINAL part331 7-Eleven CALCIUM CARBONATE 750 mg/1 N 20181231 10202-490_c76c983e-d680-4908-b79d-968a2e4b1246 10202-490 HUMAN OTC DRUG 7 Select Naproxen Sodium Naproxen Sodium TABLET ORAL 20140811 ANDA ANDA074661 7-Eleven NAPROXEN SODIUM 220 mg/1 N 20181231 10202-498_46949861-f48b-47ae-acad-9ac8c97ea77d 10202-498 HUMAN OTC DRUG 7 select mucus relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20141026 ANDA ANDA078912 7-Eleven GUAIFENESIN 600 mg/1 N 20181231 10202-526_98ed9925-0dcb-45f3-b27d-9188d433b9bb 10202-526 HUMAN OTC DRUG 7 Select Hemorrhoidal Original Strength Mineral oil, Petrolatum, and Phenylephrine HCl OINTMENT TOPICAL 20161207 OTC MONOGRAPH FINAL part346 7-ELEVEN, INC. PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL; PETROLATUM 2.5; 140; 749 mg/g; mg/g; mg/g N 20181231 10202-571_f2a69f9c-6467-4fa8-a969-736a39beb142 10202-571 HUMAN OTC DRUG 7 Select Allergy Relief fexofenadine hcl TABLET, FILM COATED ORAL 20140417 ANDA ANDA076447 7-Eleven FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 10202-604_52caed9e-acce-4e25-af7a-fd61264fede0 10202-604 HUMAN OTC DRUG 7 select ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20140807 ANDA ANDA072096 7-Eleven IBUPROFEN 200 mg/1 N 20181231 10202-612_9231e23a-00c0-4214-9a61-9eb04b0f415d 10202-612 HUMAN OTC DRUG 7 Select Allergy Relief Loratadine TABLET ORAL 20140514 ANDA ANDA076301 7-Eleven LORATADINE 10 mg/1 N 20181231 10202-647_66e2a92c-2827-413f-9349-898cc7dc009a 10202-647 HUMAN OTC DRUG 7 Select Ibuprofen Ibuprofen TABLET, COATED ORAL 20140513 ANDA ANDA072096 7-Eleven IBUPROFEN 200 mg/1 N 20181231 10202-656_ba57bfae-d224-4afb-9345-3ff1e566bdf7 10202-656 HUMAN OTC DRUG 7 select day time relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20140805 OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 10202-664_35512b9e-2d9f-4401-96bb-4567ecbe7e4f 10202-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20160413 OTC MONOGRAPH NOT FINAL part356 7-Eleven EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10202-849_5f8d597b-7b0d-1c26-e053-2991aa0a6bc1 10202-849 HUMAN OTC DRUG 7 Select Original Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20161004 OTC MONOGRAPH FINAL part341 7-ELEVEN, INC. OXYMETAZOLINE HYDROCHLORIDE .05 g/mL N 20181231 10202-850_5eff766f-8309-4cd6-e053-2a91aa0a4782 10202-850 HUMAN OTC DRUG 7 Select Redness Relief Glycerin and Naphazoline HCI SOLUTION/ DROPS OPHTHALMIC 20170328 OTC MONOGRAPH FINAL part349 7-Select, Inc NAPHAZOLINE HYDROCHLORIDE; GLYCERIN .00012; .0025 mg/mL; mg/mL N 20181231 10202-851_2505a788-39bc-4588-a35c-15dfb7b8e9a7 10202-851 HUMAN OTC DRUG 7 Select First Aid Triple Antibiotic Bacitracin, Neomycin, and Polymyxin B OINTMENT TOPICAL 20161208 OTC MONOGRAPH FINAL part333B 7-ELEVEN, INC. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 10202-852_0d516a31-4469-4aaa-96c1-d72b78d63bac 10202-852 HUMAN OTC DRUG 7 Select Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20140422 ANDA ANDA091429 7-Eleven RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 10202-853_e09d2585-f840-427c-968b-b8e74b7d4da7 10202-853 HUMAN OTC DRUG 7 Select Oral Pain Maximum Strength Relief Benzocaine GEL TOPICAL 20161208 OTC MONOGRAPH NOT FINAL part356 7-ELEVEN, INC. BENZOCAINE 200 mg/g N 20181231 10202-897_c779adae-1e67-48f1-9197-769baebe6178 10202-897 HUMAN OTC DRUG 7 Select Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20140805 ANDA ANDA074937 7-Eleven IBUPROFEN 100 mg/5mL N 20181231 10202-945_43ec6e0a-9404-4ede-a874-289db87b6cb1 10202-945 HUMAN OTC DRUG DAYTIME SEVERE COLD AND COUGH acetaminophen, dextromethorphan hbr and phenylephrine hcl SYRUP ORAL 20171130 OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 10202-946_4c2a99fa-17e0-48c6-b9a3-460da5b5ab4b 10202-946 HUMAN OTC DRUG Pain Away plus Sleep aid acetaminophen, diphenhydramine hydrochloride LIQUID ORAL 20171201 OTC MONOGRAPH NOT FINAL part343 7-Eleven ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/15mL; mg/15mL N 20181231 10202-947_e13e5624-dfd1-4694-8bc5-c721b4a512a0 10202-947 HUMAN OTC DRUG Fast Maximum Night Time Cold and Flu Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl SOLUTION ORAL 20171201 OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 10202-964_625964d4-fe10-43c2-a895-510f60e0d53c 10202-964 HUMAN OTC DRUG 7 select night time severe cold cough and flu Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20160125 OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 10202-974_079d0796-8970-4046-8fa5-ebbaccbdb98f 10202-974 HUMAN OTC DRUG 7 Select Childrens Allergy Relief cetirizine hydrochloride SOLUTION ORAL 20140805 ANDA ANDA090254 7-Eleven CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 10202-994_6ba6ea9b-cbe8-4258-8f24-5f81724ee2f2 10202-994 HUMAN OTC DRUG 7 select day time relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20140422 OTC MONOGRAPH FINAL part341 7-Eleven ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 10210-0002_01c444c1-e986-4ab6-995a-0aff1502e3d7 10210-0002 HUMAN OTC DRUG CARMEX strawberry lip balm BROAD SPECTRUM SPF 15 SUNSCREEN AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 2.5; 3; 5; 4 g/100g; g/100g; g/100g; g/100g E 20171231 10210-0004_3a931fb7-4df7-45d2-bab5-516ba9b7de5b 10210-0004 HUMAN OTC DRUG CARMEX Pomegranate BROAD SPECTRUM SPF 15 SUNSCREEN AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 2.5; 3; 5; 4 g/100g; g/100g; g/100g; g/100g E 20171231 10210-0005_6b7f4bb5-ede8-47cd-b03b-58d781366a56 10210-0005 HUMAN OTC DRUG CARMEX Lime twist BROAD SPECTRUM SPF 15 SUNSCREEN AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 2.5; 3; 5; 4 g/100g; g/100g; g/100g; g/100g E 20171231 10210-0006_178917c6-9ca9-4a18-a9e1-2f72e43465ea 10210-0006 HUMAN OTC DRUG CARMEX Vanilla BROAD SPECTRUM SPF 15 SUNSCREEN AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 2.5; 3; 5; 4 g/100g; g/100g; g/100g; g/100g E 20171231 10210-0007_2a78fea0-405b-4c54-af07-1d6b8728f511 10210-0007 HUMAN OTC DRUG CARMEX moisture Plus Ultra Hydrating Lip Balm Broad Spectrum SPF 15 Sunscreen AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE TOPICAL 20131002 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 2.5; 3.3; 5.5; 4.4 g/100g; g/100g; g/100g; g/100g E 20171231 10210-0012_77e300b9-1682-4fe6-8c29-0a6b3693b6f8 10210-0012 HUMAN OTC DRUG CARMEX COLD SORE treatment External Analgesic BENZOCAINE CREAM TOPICAL 20140528 OTC MONOGRAPH NOT FINAL part348 Carma Laboratories, Inc. BENZOCAINE 10 g/100g E 20171231 10210-0013_3fdb4062-cb89-65e8-e054-00144ff8d46c 10210-0013 HUMAN OTC DRUG Carmex Daily Care Moisturizing Lip Balm Orange Dream SPF 15 OCTINOXATE, OXYBENZONE SALVE TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. OCTINOXATE; OXYBENZONE 7.5; 4 g/100g; g/100g N 20181231 10210-0014_3fdb949c-85ad-724d-e054-00144ff8d46c 10210-0014 HUMAN OTC DRUG Carmex Daily Care Moisturizing Lip Balm Tropical Colada SPF 15 OCTINOXATE, OXYBENZONE SALVE TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. OCTINOXATE; OXYBENZONE 7.5; 4 g/100g; g/100g N 20181231 10210-0015_3fdba3ac-69c5-155f-e054-00144ff88e88 10210-0015 HUMAN OTC DRUG Carmex Daily Care Moisturizing Lip Balm Honey Dew Melon SPF 15 OCTINOXATE, OXYBENZONE SALVE TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. OCTINOXATE; OXYBENZONE 7.5; 4 g/100g; g/100g N 20181231 10210-0016_3fdb7c1f-df33-0f50-e054-00144ff88e88 10210-0016 HUMAN OTC DRUG Carmex Daily Care moisturizing Lip Balm Winter Mint SPF 15 OCTINOXATE, OXYBENZONE SALVE TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. OCTINOXATE; OXYBENZONE 7.5; 4 g/100g; g/100g N 20181231 10210-0017_6182580e-3c5b-1eae-e053-2a91aa0af7f4 10210-0017 HUMAN OTC DRUG Carmex Daily Care Moisturizing Lip Balm SPF 15 OCTINOXATE, PETROLATUM KIT 20160926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. N 20181231 10210-0022_3fdb949c-85dc-724d-e054-00144ff8d46c 10210-0022 HUMAN OTC DRUG Carmex Classic Lip Balm Medicated CAMPHOR (SYNTHETIC), PETROLATUM SALVE TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part348 Carma Laboratories, Inc. CAMPHOR (SYNTHETIC); PETROLATUM 1.77; 45.3 g/100g; g/100g N 20181231 10210-0023_3fdba3ac-69de-155f-e054-00144ff88e88 10210-0023 HUMAN OTC DRUG Carmex Classic Lip Balm Medicated SPF 15 OCTINOXATE, OXYBENZONE, PETROLATUM SALVE TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 4; 35 g/100g; g/100g; g/100g N 20181231 10210-0024_3fdbf9dd-0a48-1eae-e054-00144ff88e88 10210-0024 HUMAN OTC DRUG Carmex Classic Lip Balm Cherry SPF 15 OCTINOXATE, OXYBENZONE, PETROLATUM SALVE TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 4; 35 g/100g; g/100g; g/100g N 20181231 10210-0025_3fdba3ac-69ef-155f-e054-00144ff88e88 10210-0025 HUMAN OTC DRUG Carmex Classic Lip Balm Strawberry SPF 15 OCTINOXATE, OXYBENZONE, PETROLATUM SALVE TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part352 Carma Laboratories, Inc. OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 4; 35 g/100g; g/100g; g/100g N 20181231 10216-3071_983a1364-6118-4d7e-9b80-5011306c0b7d 10216-3071 HUMAN PRESCRIPTION DRUG Topex Cherry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DENTSPLY Caulk BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 10216-3081_983a1364-6118-4d7e-9b80-5011306c0b7d 10216-3081 HUMAN PRESCRIPTION DRUG Topex Mint Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DENTSPLY Caulk BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 10216-3091_983a1364-6118-4d7e-9b80-5011306c0b7d 10216-3091 HUMAN PRESCRIPTION DRUG Topex Pina Colada Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DENTSPLY Caulk BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 10216-3110_983a1364-6118-4d7e-9b80-5011306c0b7d 10216-3110 HUMAN PRESCRIPTION DRUG Topex BUBBLE GUM Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER DENTSPLY Caulk BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 10218-001_bd9596f6-e486-4b65-b34e-83ed2e83230e 10218-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19970405 NDA NDA205767 CEE-KAY SUPPLY, INC. OXYGEN 995 mL/L N 20181231 10218-003_a56d0953-3917-4c8a-a513-cd8aef7d2c8b 10218-003 HUMAN PRESCRIPTION DRUG AIR BREATHING AIR GAS RESPIRATORY (INHALATION) 20050801 UNAPPROVED MEDICAL GAS CEE-KAY SUPPLY, INC. AIR 100 L/100L E 20171231 10218-102_6353c22e-636e-4c4c-80e4-5a1a728e7e81 10218-102 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19970405 NDA NDA205766 CEE-KAY SUPPLY, INC. NITROGEN 995 mL/L N 20181231 10221-001_397f6e25-5f97-48d9-a773-4de84d66dc55 10221-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19690101 NDA NDA205849 Central McGowan Inc OXYGEN 992 mL/L N 20181231 10221-002_567168af-08f3-48ae-967c-02788488c248 10221-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20140201 NDA NDA205850 Central-McGowan, Inc. NITROGEN 99 L/100L N 20181231 10223-0201_54cdf552-81f5-49ad-a5c3-1987f6ea1990 10223-0201 HUMAN PRESCRIPTION DRUG Cetacaine Anesthetic Benzocaine, Butamben, and Tetracaine Hydrochloride AEROSOL, SPRAY TOPICAL 19580101 UNAPPROVED DRUG OTHER Cetylite Industries, Inc. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE .028; .004; .004 g/.2g; g/.2g; g/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 10223-0202_422cbbb5-4532-4d2f-9e49-67593eb1c5f2 10223-0202 HUMAN PRESCRIPTION DRUG Cetacaine Anesthetic Benzocaine, Butamben, and Tetracaine Hydrochloride SOLUTION TOPICAL 19600101 UNAPPROVED DRUG OTHER Cetylite Industries, Inc. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE .028; .004; .004 g/.2g; g/.2g; g/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 10223-0217_ce0162c6-6b25-4f0f-b0c6-dff4824cbe19 10223-0217 HUMAN PRESCRIPTION DRUG Cetacaine Topical Anesthetic Benzocaine, Butamben, and Tetracaine Hydrochloride GEL TOPICAL 19600101 UNAPPROVED DRUG OTHER Cetylite Industries, Inc. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE .028; .004; .004 g/.2g; g/.2g; g/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 10223-0221_ce0162c6-6b25-4f0f-b0c6-dff4824cbe19 10223-0221 HUMAN PRESCRIPTION DRUG Cetacaine Topical Anesthetic Benzocaine, Butamben, and Tetracaine Hydrochloride GEL TOPICAL 19600101 UNAPPROVED DRUG OTHER Cetylite Industries, Inc. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE .028; .004; .004 g/.2g; g/.2g; g/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 10237-589_0e3bb3f3-d622-4b1a-920a-ada8a53e9886 10237-589 HUMAN OTC DRUG Arm and Hammer Baking Soda Sodium Bicarbonate POWDER, FOR SOLUTION ORAL 20000101 OTC MONOGRAPH FINAL part331 Church & Dwight Co., Inc. SODIUM BICARBONATE 1 g/g N 20181231 10237-614_09340da6-1a71-41ee-b854-e4d871939909 10237-614 HUMAN OTC DRUG Mentadent Advanced Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20040401 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-616_c1490cc6-b712-4f7b-b1c7-ef5b74a2fef7 10237-616 HUMAN OTC DRUG Mentadent Advanced Breath Freshening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20040401 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-625_aa218d12-9987-4516-a9ac-57f328e636e1 10237-625 HUMAN OTC DRUG AIM Bubble Berry Sodium Fluoride GEL, DENTIFRICE DENTAL 20080101 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-626_d36d9769-317c-42e1-b7ab-789e2f44ece3 10237-626 HUMAN OTC DRUG AIM CAVITY PROTECTION Multi Benefit Sodium Fluoride GEL, DENTIFRICE DENTAL 20040301 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-628_c7d49659-efab-4313-963a-dd5ef70c6920 10237-628 HUMAN OTC DRUG AIM TARTAR CONTROL Plus Mouthwash and Whitening Sodium Fluoride GEL, DENTIFRICE DENTAL 20040301 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-629_44c80941-3a75-4676-a134-eab0752f450b 10237-629 HUMAN OTC DRUG AIM Whitening with Baking Soda Sodium Fluoride GEL, DENTIFRICE DENTAL 20040714 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-630_9b4596f6-0098-4683-94c6-614c872c069a 10237-630 HUMAN OTC DRUG AIM Cavity Protection with Whitening Sodium Fluoride GEL, DENTIFRICE DENTAL 20101110 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-631_2ef7e48b-dc5b-4285-ab76-6e4ae9921417 10237-631 HUMAN OTC DRUG AIM Cavity Protection Multi Benefit Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110804 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-632_1222bc2f-6e78-6cbc-e054-00144ff8d46c 10237-632 HUMAN OTC DRUG Aim Sensitive Cavity Protection Potassium nitrate, Sodium Fluoride GEL, DENTIFRICE DENTAL 20150325 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.4 mg/g; mg/g N 20181231 10237-633_1d0f8a33-0b02-40e2-e054-00144ff88e88 10237-633 HUMAN OTC DRUG AIM CAVITY PROTECTION Multi Benefit Sodium Fluoride GEL, DENTIFRICE DENTAL 20040301 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-635_1d0fc71c-d28d-4afa-e054-00144ff8d46c 10237-635 HUMAN OTC DRUG AIM TARTAR CONTROL Plus Mouthwash and Whitening Sodium Fluoride GEL, DENTIFRICE DENTAL 20040301 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-636_1d0fd0b4-33bb-5764-e054-00144ff88e88 10237-636 HUMAN OTC DRUG AIM Whitening with Baking Soda Sodium Fluoride GEL, DENTIFRICE DENTAL 20040714 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-637_1d475e82-2331-5b8a-e054-00144ff8d46c 10237-637 HUMAN OTC DRUG AIM Cavity Protection with Whitening Sodium Fluoride GEL, DENTIFRICE DENTAL 20101110 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-638_1d47c34b-55d3-6b6a-e054-00144ff8d46c 10237-638 HUMAN OTC DRUG AIM Cavity Protection Multi Benefit Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110804 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-644_056bb79a-fe0a-4076-aeb7-a39591c7036d 10237-644 HUMAN OTC DRUG CLOSE UP Freshening with Mouthwash Sodium Fluoride GEL, DENTIFRICE DENTAL 20010301 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-645_3c739677-f7a8-4ce8-8c3a-b8365a77dd8d 10237-645 HUMAN OTC DRUG CLOSE UP Whitening with Mouthwash Sodium Fluoride GEL, DENTIFRICE DENTAL 20101026 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-646_fa6d06a4-c39d-41c9-876d-b2c020413ba0 10237-646 HUMAN OTC DRUG CLOSE UP Freshening with Mouthwash Sodium Fluoride PASTE, DENTIFRICE DENTAL 20101026 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-650_1f808f59-48cb-4895-abf1-57bec3ddc0ac 10237-650 HUMAN OTC DRUG Pepsodent Complete Care Enamel-Safe WHITENING Sodium Fluoride PASTE, DENTIFRICE DENTAL 20040301 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-651_322d957f-fa9b-4450-9541-4a04134eea1c 10237-651 HUMAN OTC DRUG Pepsodent Complete Care Original Sodium Fluoride PASTE, DENTIFRICE DENTAL 20040301 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-652_5ef4a28a-5399-4fbc-a541-8c8ea1f52c59 10237-652 HUMAN OTC DRUG Dental Care Advance Cleaning Maximun Baking Soda Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-653_bb54412b-618b-4227-84fa-b8f7560c8a7f 10237-653 HUMAN OTC DRUG Complete Care Tartar Control Plus Whitening Baking Soda and Peroxide Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-654_a3723f80-2466-4fe3-a0c1-860a5d3743f5 10237-654 HUMAN OTC DRUG Complete Care Plus Enamel Strengthening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-655_9473282b-a873-46fa-8c6a-0575338e89e8 10237-655 HUMAN OTC DRUG Peroxie Care Tartar Control Healthy Gums Baking Soda and Peroxide Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-656_d3e8e7ba-5bee-4cda-b2f0-70dd9ad2c8ac 10237-656 HUMAN OTC DRUG Advance White Tartar Control Breath Freshening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-657_f11c7825-4f1c-437d-a2ed-9e06edb09f0e 10237-657 HUMAN OTC DRUG Advance White Breath Freshening Tartar Control Sodium Fluoride GEL, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-658_520c8392-00f6-4fda-b3b4-879f803d6744 10237-658 HUMAN OTC DRUG Advance White Extreme Whitening Tartar Control Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-659_47e415a8-8b9a-4be4-ae9d-59170afd4b1e 10237-659 HUMAN OTC DRUG Sensitive MultiProtection with Tartar Control Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE; POTASSIUM NITRATE 2.43; 50 mg/g; mg/g N 20181231 10237-660_f707731f-161a-4b4c-b81e-f55c0024f358 10237-660 HUMAN OTC DRUG Sensitive Whitening with Baking Soda Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE; POTASSIUM NITRATE 2.43; 50 mg/g; mg/g N 20181231 10237-661_f20a5fcf-a743-4885-b573-3673e0a3def0 10237-661 HUMAN OTC DRUG Arm and Hammer Orajel Sensitive Freshening with Flavor Burst Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120129 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE; POTASSIUM NITRATE 1.1; 50 mg/g; mg/g N 20181231 10237-662_2719e106-d776-1baa-e054-00144ff88e88 10237-662 HUMAN OTC DRUG Truly Radiant Whitening and Strengthening Rinse Sodium Fluoride 0.02% LIQUID ORAL 20141023 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 10237-663_0e21c699-7486-5f56-e054-00144ff88e88 10237-663 HUMAN OTC DRUG Truly Radiant Whitening and Enamel Strengthening Sodium Fluoride 0.243% PASTE, DENTIFRICE DENTAL 20140101 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE .243 mg/g N 20181231 10237-664_4f18de32-f8ed-4972-e054-00144ff88e88 10237-664 HUMAN OTC DRUG Truly Radiant Rejuvenating Whitening Sodium Fluoride 0.243% PASTE, DENTIFRICE DENTAL 20150101 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE .243 mg/g N 20181231 10237-665_2121c3b3-e681-41fb-e054-00144ff8d46c 10237-665 HUMAN OTC DRUG Truly Radiant Clean and Fresh Fluoride Rinse Sodium Fluoride 0.02% LIQUID ORAL 20151002 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 10237-667_4f2c162f-2e39-2bc6-e054-00144ff8d46c 10237-667 HUMAN OTC DRUG Truly Radiant Bright and Strong Sodium fluoride PASTE, DENTIFRICE DENTAL 20151116 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE .243 mg/g N 20181231 10237-668_4f2dd884-42b3-0c29-e054-00144ff8d46c 10237-668 HUMAN OTC DRUG Truly Radiant Clean and Fresh Sodium Monofluorophosphate 0.833% PASTE, DENTIFRICE DENTAL 20151215 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM MONOFLUOROPHOSPHATE .833 mg/g N 20181231 10237-694_284b6a0f-7c77-424e-a2b8-d0569fe16afa 10237-694 HUMAN OTC DRUG Simply Saline Plus Wound Wash Antibacterial First Aid Antiseptic Benzethonium Chloride SPRAY TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333A Church & Dwight Co., Inc. BENZETHONIUM CHLORIDE .13 mL/mL N 20181231 10237-695_8e5918a5-9a08-493d-9089-31ded025dd7d 10237-695 HUMAN OTC DRUG Simple Saline Cold Formula plus Menthol Luffa operculata, Sabadilla SPRAY NASAL 20110512 UNAPPROVED HOMEOPATHIC Church & Dwight Co., Inc. LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 6; 6 [hp_X]/30mL; [hp_X]/30mL N 20181231 10237-696_0dc80cd5-cde6-45b4-8393-ebde6bf0abed 10237-696 HUMAN OTC DRUG Simple Saline plus Childrens Cold Formula plus Moisturizers Luffa operculata, Sabadilla SPRAY NASAL 20110512 UNAPPROVED HOMEOPATHIC Church & Dwight Co., Inc. LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 6; 6 [hp_X]/30mL; [hp_X]/30mL N 20181231 10237-697_e6f02d9a-f1b3-492c-8ad9-c53fa7e6458a 10237-697 HUMAN OTC DRUG Simply Saline Wound Wash Benzethonium Chloride 0.13% SPRAY TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333A Church & Dwight Co., Inc. BENZETHONIUM CHLORIDE 1 mg/13mL N 20181231 10237-703_52266132-3a1c-471d-96a3-a8e1c0c4bdaf 10237-703 HUMAN OTC DRUG Orajel Maximum Strength Benzocaine LIQUID TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE .2 mL/mL N 20181231 10237-704_f0b25a23-829e-41c4-8cdc-58faaf3c243f 10237-704 HUMAN OTC DRUG Orajel Instant Pain Relief Regular Strength Benzocaine GEL TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 100 mg/g N 20181231 10237-705_32eb752d-6253-4768-980f-b1e215becf89 10237-705 HUMAN OTC DRUG Orajel for Toothache Maximum Strength Benzocaine SWAB TOPICAL 20100811 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE .2 mL/mL N 20181231 10237-707_2c093d64-6433-4712-b639-90adc8cb8372 10237-707 HUMAN OTC DRUG Orajel Instant Pain Reliver for Canker Sores Extra Strength Pain Relief Benzocaine, Menthol GEL TOPICAL 20100729 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; MENTHOL 150; 20 mg/g; mg/g N 20181231 10237-708_2334b033-51b1-4f69-921d-d546aaf3638a 10237-708 HUMAN OTC DRUG Orajel Instant Pain Relief Maximum Strength Benzocaine GEL TOPICAL 20100611 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZALKONIUM CHLORIDE; BENZOCAINE; ZINC CHLORIDE .4; 200; 1 mg/g; mg/g; mg/g N 20181231 10237-709_655a1dc1-321e-4202-a8b8-d657c7b5732a 10237-709 HUMAN OTC DRUG Orajel for All Mouth Sores Maximum Strength Benzocaine SWAB TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE .2 mL/mL N 20181231 10237-714_a189bb64-5de9-4a9d-b140-0476cbab2e1b 10237-714 HUMAN OTC DRUG Orajel Instant Relief for Teething Pain Cooling Cucumber Benzocaine GEL TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 75 mg/g N 20181231 10237-719_5be76374-91b7-4f74-86e0-16a07ca17968 10237-719 HUMAN OTC DRUG Orajel Dry Mouth Moistruizing Glycerin GEL TOPICAL 20100721 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. GLYCERIN 180 mg/g N 20181231 10237-720_9d4e6d0a-1b2d-4861-8952-3a7bbbdadbe6 10237-720 HUMAN OTC DRUG Orajel Antiseptic Rinse for Mouth Sores Hydrogen peroxide LIQUID ORAL 20100729 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. HYDROGEN PEROXIDE .015 mL/mL N 20181231 10237-721_2f044f4a-9999-4b27-b7e7-645d4627ff3c 10237-721 HUMAN OTC DRUG Orajle Anti-Bacterial Rinse for Bleeding Gums Cetylpyridinium chloride LIQUID ORAL 20100730 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. CETYLPYRIDINIUM CHLORIDE .001 mL/mL N 20181231 10237-722_2c22ca26-28f5-417c-ab47-69470dbf4c58 10237-722 HUMAN OTC DRUG Orajel Severe Toothache Maximum Strength Fast-Acting Formula Benzocaine LIQUID TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE .2 mL/mL N 20181231 10237-726_ca4b753c-3809-41ac-8a88-eb295743dda0 10237-726 HUMAN OTC DRUG Orajel for Codl Sores Relief and Concealer Allantoin Benzocaine Camphor CREAM TOPICAL 20100719 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; CAMPHOR (NATURAL); ALLANTOIN; DIMETHICONE; MENTHOL; PETROLATUM 200; 30; 5; 20; 10; 640 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10237-727_9e107187-a29c-4e1c-8b4a-93d1d6f44e76 10237-727 HUMAN OTC DRUG Orajel Anticavity Sodium Fluoride GEL, DENTIFRICE DENTAL 20140101 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-728_493f60ce-a42c-4ce5-9970-9f50c2a57ae2 10237-728 HUMAN OTC DRUG Orajel Kids My Way Anticavity Toothpaste Sodium Fluoride GEL, DENTIFRICE DENTAL 20110201 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-735_0dccd6e6-ed89-4a49-8602-af731c6ef123 10237-735 HUMAN OTC DRUG Orajel Instant Relief for Teething Pain Longer Lasting Benzocaine GEL TOPICAL 20110322 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 75 mg/g N 20181231 10237-736_3355fb23-7837-4fa5-961f-76bed90b676c 10237-736 HUMAN OTC DRUG Orajel Instant Relief for Teething Pain Benzocaine SWAB TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE .075 mL/mL N 20181231 10237-738_6ffc29ea-0ac2-4370-990c-dfcc08185f90 10237-738 HUMAN OTC DRUG Orajel Nighttime Instant Relief for Teething Pain Longer Lasting Extra Strength Benzocaine GEL TOPICAL 20100618 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 100 mg/g N 20181231 10237-739_1c8ff394-f120-4377-8c63-897eadcaddb6 10237-739 HUMAN OTC DRUG Orajel Instant Relief for Teething Pain Daytime Nighttime Twin Pack Benzocaine KIT 20110322 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. N 20181231 10237-740_c3fbca88-f485-41b0-9efc-7b08d18dd51f 10237-740 HUMAN OTC DRUG Orajel Kids My Way Anticavity Toothpaste Sodium Fluoride GEL, DENTIFRICE DENTAL 20120201 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-741_8a56db8c-0ec2-455e-8e83-fe1ebd6a5d7e 10237-741 HUMAN OTC DRUG Orajel for Cold Sores Single Dose Benzalkonium Chloride, Benzocaine LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZALKONIUM CHLORIDE; BENZOCAINE .13; .5 mg/mL; mg/mL N 20181231 10237-742_40bd06e5-57be-6d5c-e054-00144ff8d46c 10237-742 HUMAN OTC DRUG Baby Orajel Naturals for Teething Pain Relief Calcarea phosphorica, Chamomilla, Coffea cruda GEL TOPICAL 20121201 UNAPPROVED HOMEOPATHIC Church & Dwight Co., Inc. TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; ARABICA COFFEE BEAN 12; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 10237-743_5fda924c-842e-43af-98c2-a547150d514c 10237-743 HUMAN OTC DRUG Orajel Kids My Way Anticavity Sodium Fluoride GEL, DENTIFRICE DENTAL 20130201 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 10237-744_40cbe40f-ce58-16ba-e054-00144ff88e88 10237-744 HUMAN OTC DRUG Baby Orajel Naturals for Teething Pain Relief Nighttime Formula Calcarea phosphorica, Chamomilla, Coffea cruda,Passiflora incarnata GEL TOPICAL 20131202 UNAPPROVED HOMEOPATHIC Church & Dwight Co., Inc. TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; PASSIFLORA INCARNATA FLOWER 12; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 10237-745_3fec0c2f-12a8-4e59-85f2-561838078fa2 10237-745 HUMAN OTC DRUG Orajel Instant Pain Relief Regular Benzocaine 10% GEL TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZOCAINE 100 mg/g N 20181231 10237-746_62aa9807-d15c-45c8-a8c3-50a08d96123c 10237-746 HUMAN OTC DRUG Orajel Instant Pain Relief Maximum Benzocaine 20%, Benzalkonium Chloride GEL TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZOCAINE; BENZALKONIUM CHLORIDE 200; 1 mg/g; mg/g N 20181231 10237-747_4c6ea515-ad26-3d66-e054-00144ff8d46c 10237-747 HUMAN OTC DRUG Orajel Instant Pain Relief Severe Benzocaine 20%, Menthol, Benzalkonium Chloride CREAM TOPICAL 20170227 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZOCAINE; BENZALKONIUM CHLORIDE; MENTHOL 200; 1; 25 mg/g; mg/g; mg/g N 20181231 10237-747_4ce932f7-46fe-2caf-e054-00144ff88e88 10237-747 HUMAN OTC DRUG Orajel Instant Pain Relief Severe Benzocaine 20%, Menthol, Benzalkonium Chloride CREAM TOPICAL 20170227 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZOCAINE; BENZALKONIUM CHLORIDE; MENTHOL 200; 1; 25 mg/g; mg/g; mg/g N 20181231 10237-748_319151fb-fce6-4103-8301-f8e4dabc2543 10237-748 HUMAN OTC DRUG Orajel Instant Pain Relief Severe PM Benzocaine 20%, Menthol, Benzalkonium Chloride CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZOCAINE; BENZALKONIUM CHLORIDE; MENTHOL 200; 1; 25 mg/g; mg/g; mg/g N 20181231 10237-750_5fb1d5b1-9752-3314-e053-2991aa0a2f86 10237-750 HUMAN OTC DRUG Orajel for Cold Sores Benzocaine CREAM TOPICAL 20100727 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; PETROLATUM 200; 744.4 mg/g; mg/g N 20181231 10237-752_4c58c53b-a18f-2953-e054-00144ff8d46c 10237-752 HUMAN OTC DRUG Orajel Instant Pain Relief Severe Benzocaine 20%, Menthol, Benzalkonium Chloride GEL TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZOCAINE; BENZALKONIUM CHLORIDE; MENTHOL 200; 1; 50 mg/g; mg/g; mg/g N 20181231 10237-753_30928a98-5e42-446a-8bbd-f97a46560711 10237-753 HUMAN OTC DRUG Orajel Instant Pain Relief SEVERE Benzocaine 20% LIQUID TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 200 mg/g N 20181231 10237-755_e26a1ff7-ea87-4359-b9ab-14127bc9802d 10237-755 HUMAN OTC DRUG Orajel Instant Pain Relief MAXIMUM Benzocaine 20% LIQUID TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE 200 mg/g N 20181231 10237-756_3918a62f-ac14-19aa-e054-00144ff8d46c 10237-756 HUMAN OTC DRUG Orajel for Cold Sores Single Dose Benzalkonium Chloride, Benzocaine LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZALKONIUM CHLORIDE; BENZOCAINE .13; .5 mg/g; mg/g N 20181231 10237-757_40f4cc70-674b-44ef-e054-00144ff88e88 10237-757 HUMAN OTC DRUG Baby Orajel Naturals Twin Pack Orajel Naturals GEL TOPICAL 20150101 UNAPPROVED HOMEOPATHIC Church & Dwight Co., Inc. TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWER; ARABICA COFFEE BEAN 12; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 10237-759_0607f088-d44f-2961-e054-00144ff8d46c 10237-759 HUMAN OTC DRUG Orajel Alcohol Free Antiseptic Rinse For All Mouth Sores Hydrogen Peroxide 1.5%, Menthol 0.1% LIQUID ORAL 20141101 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. HYDROGEN PEROXIDE; MENTHOL 1.5; 1 mL/mL; mg/mL N 20181231 10237-760_06188d36-0d61-6ae6-e054-00144ff8d46c 10237-760 HUMAN OTC DRUG Orajel Antiseptic Rinse For All Mouth Sores Hydrogen Peroxide 1.5%, Menthol 0.1% LIQUID ORAL 20141101 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. HYDROGEN PEROXIDE; MENTHOL 1.5; 1 mL/mL; mg/mL N 20181231 10237-761_3761c7b3-053c-0f50-e054-00144ff88e88 10237-761 HUMAN OTC DRUG Orajel Cold Sore Moisturelock Benzocaine CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; ALLANTOIN; CAMPHOR (NATURAL); DIMETHICONE; MENTHOL; PETROLATUM 200; 5; 30; 20; 10; 640 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10237-762_505a73f5-fc6e-738c-e054-00144ff88e88 10237-762 HUMAN OTC DRUG Orajel Instant Pain Relief Maximum Benzocaine 20%, Benzalkonium Chloride GEL TOPICAL 20160727 OTC MONOGRAPH NOT FINAL part356 Church Dwight Co., Inc. BENZOCAINE; MENTHOL 200; 26 mg/g; mg/g N 20181231 10237-763_438ae02a-dcf5-38c9-e054-00144ff8d46c 10237-763 HUMAN OTC DRUG Orajel Fluoride Sodium Fluoride GEL, DENTIFRICE DENTAL 20161210 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 6 mg/g N 20181231 10237-764_41709710-5393-3119-e054-00144ff88e88 10237-764 HUMAN OTC DRUG Orajel Toothache Rinse Benzyl Alcohol, Zinc Chloride LIQUID TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZYL ALCOHOL; ZINC CHLORIDE 2.91; 1.62 mg/mL; mg/mL N 20181231 10237-765_43cb4a9f-974f-4243-e054-00144ff8d46c 10237-765 HUMAN OTC DRUG Orajel Denture Pain Relief Benzocaine, Benzalkonium Chloride, Menthol GEL TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. MENTHOL; BENZOCAINE 26; 200 mg/g; mg/g N 20181231 10237-766_4c0b14de-da1f-4c43-e054-00144ff88e88 10237-766 HUMAN OTC DRUG Benzocaine, Menthol, Zinc Chloride Orajel Instant Pain Relief Severe CREAM TOPICAL 20170220 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; MENTHOL; ZINC CHLORIDE 200; 25; 100 mg/g; mg/g; mg/g N 20181231 10237-767_4bcd575f-d77b-10d8-e054-00144ff88e88 10237-767 HUMAN OTC DRUG Benzocaine Orajel Severe Toothache LIQUID TOPICAL 20170324 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; MENTHOL 200; 10 g/mg; g/mg N 20181231 10237-768_4c71b852-793b-4e8d-e054-00144ff8d46c 10237-768 HUMAN OTC DRUG Benzocaine, Menthol, Zinc Chloride Orajel Instant Pain Relief Severe CREAM TOPICAL 20170220 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; ZINC CHLORIDE; MENTHOL 200; 1.5; 2.5 mg/g; mg/g; mg/g N 20181231 10237-769_4e1278e8-d182-05bf-e054-00144ff88e88 10237-769 HUMAN OTC DRUG Benzocaine, Menthol, Zinc Chloride Orajel Instant Pain Relief Severe GEL TOPICAL 20170426 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; ZINC CHLORIDE; MENTHOL 200; 2.5; 50 mg/g; mg/g; mg/g N 20181231 10237-770_4ce8bcab-6d59-6b12-e054-00144ff8d46c 10237-770 HUMAN OTC DRUG Benzocaine, Menthol, Zinc Chloride Orajel Instant Pain Relief Severe CREAM TOPICAL 20170220 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. ZINC CHLORIDE; MENTHOL; BENZOCAINE 1.5; 2.5; 200 mg/g; mg/g; mg/g N 20181231 10237-771_4e27ab57-7c3c-6725-e054-00144ff88e88 10237-771 HUMAN OTC DRUG Benzocaine, Menthol, Zinc Chloride Orajel Severe PM Toothache and Gum Relief CREAM TOPICAL 20170427 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; ZINC CHLORIDE; MENTHOL 200; 1.5; 25 mg/g; mg/g; mg/g N 20181231 10237-772_552511b1-101d-7212-e054-00144ff88e88 10237-772 HUMAN OTC DRUG Orajel Denture Pain Relief Benzocaine, Menthol, Zinc Chloride GEL TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Co., Inc. BENZOCAINE; MENTHOL; ZINC CHLORIDE 200; 26; 1.5 mg/g; mg/g; mg/g N 20181231 10237-773_5c4ff036-711b-373a-e053-2a91aa0a756a 10237-773 HUMAN OTC DRUG Orajel Fluoride Sodium Fluoride GEL, DENTIFRICE DENTAL 20171024 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE 6 mg/g N 20181231 10237-800_0755a1d7-6ae8-4a83-aa0a-b63fc50c1d16 10237-800 HUMAN OTC DRUG UltraMax Invisible Solid Antiperspirant Deodorant Powder Fresh Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20030619 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 10237-801_c32f8836-4bfb-4edd-8bdd-b87cdf418d48 10237-801 HUMAN OTC DRUG UltraMax Invisible Solid Antiperspirant Deodorant Unscented Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20030619 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 10237-802_898b6d1f-0435-455b-8541-0cd67b3f2b3e 10237-802 HUMAN OTC DRUG UltraMax Invisible Solid Antiperspirant Deodorant Fresh Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20030619 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 10237-803_da474de7-cca2-4d79-9fb8-177370a5bf13 10237-803 HUMAN OTC DRUG UltraMax Invisible Solid Antiperspirant Deodorant Active Sport Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20030619 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 10237-804_4d57cf44-f441-44f4-9cd9-816138e3f1d1 10237-804 HUMAN OTC DRUG UltraMax Invisible Solid Antiperspirant Deodorant Cool Blast Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20030619 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 10237-805_23dcba0c-a991-4e60-ae82-459364e23618 10237-805 HUMAN OTC DRUG UltraMax Antiperspirant Deodorant Cool Blast Aluminum Zirconium Tetrachlorohydrex Gly GEL TOPICAL 20031201 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 10237-806_2229c23b-6799-4793-e054-00144ff8d46c 10237-806 HUMAN OTC DRUG Ultra Max Tropical Sunset Aluminum Zirconium STICK TOPICAL 20141201 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g E 20171231 10237-813_b8139fde-d2ba-4345-aa43-71803de9dd48 10237-813 HUMAN OTC DRUG Arrid XX Extra Extra Dry Antiperspirant Deodorant Cool Shower Aluminum Zirconium Tetrachlorohydrex Gly 19% STICK TOPICAL 20011001 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g E 20171231 10237-814_e454dc48-e287-4a48-84ba-92bfc66bd278 10237-814 HUMAN OTC DRUG ARRID EXTRA DRY Regular Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20110422 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 246 mg/g N 20181231 10237-815_63ee7a78-971f-44bc-88e4-5b05f7b1fbb4 10237-815 HUMAN OTC DRUG ARRID EXTRA EXTRA DRY XX Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20110422 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 246 mg/g N 20181231 10237-817_02d280c5-c677-4660-831f-edb792cfd8f4 10237-817 HUMAN OTC DRUG ARRID EXTRA EXTRA DRY XX Morning Clean Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20110422 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 246 mg/g N 20181231 10237-818_1a978675-7cc3-4d63-9742-b9193525513f 10237-818 HUMAN OTC DRUG ARRID EXTRA EXTRA DRY XX Cool Shower Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20110422 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 246 mg/g E 20171231 10237-820_6869b920-6195-424c-986c-4495f3ce69cf 10237-820 HUMAN OTC DRUG ARRID EXTRA EXTRA DRY XX Ultra Clear Ultra Fresh Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20110422 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 246 mg/g N 20181231 10237-825_27e1ada3-cf5f-439b-a25f-7102aaa85235 10237-825 HUMAN OTC DRUG ARRID EXTRA DRY Antiperspirant Deodorant Ultra Fresh Aluminum Zirconium Tetrachlorohydrex Gly GEL TOPICAL 20040928 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g E 20171231 10237-826_0494194d-2fa6-4ba7-ab3e-e6d8f821aed6 10237-826 HUMAN OTC DRUG ARRID EXTRA DRY Antiperspirant Deodorant Morning Clean Aluminum Zirconium Tetrachlorohydrex Gly GEL TOPICAL 20040928 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 10237-827_3ead8364-b220-431b-941d-ca391cec014a 10237-827 HUMAN OTC DRUG ARRID EXTRA DRY Antiperspirant Deodorant Cool Shower Aluminum Zirconium Tetrachlorohydrex Gly GEL TOPICAL 20040928 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 10237-828_1159db31-6a86-4d0a-9558-4a3d0e5e8644 10237-828 HUMAN OTC DRUG ARRID XX Extra Extra Dry Invisible Solid Antiperspirant Deodorant Cool Blast Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20040928 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g E 20171231 10237-831_4830a42f-6389-49a6-86d8-c27fe12dd3b3 10237-831 HUMAN OTC DRUG Ladys Choice Invisible Solid Antiperspirant Deodorant Powder Fresh Aluminum Chlorohydrate STICK TOPICAL 20020601 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 20 g/100g E 20171231 10237-832_47ada0a5-875f-4642-a018-76306dd29809 10237-832 HUMAN OTC DRUG Ladys Choice Invisible Solid Antiperspirant Deodorant Shower Fresh Aluminum Chlorohydrate STICK TOPICAL 20020601 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 20 g/100g E 20171231 10237-833_1fb6abed-bbca-4922-b0e0-d855a3ba7aa9 10237-833 HUMAN OTC DRUG Ladys Choice Invisible Solid Antiperspirant Deodorant Cucumber Melon Aluminum Chlorohydrate STICK TOPICAL 20030601 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 20 g/100g E 20171231 10237-834_751da331-3679-4c5e-908b-1f7667c66852 10237-834 HUMAN OTC DRUG Ladys Choice Invisible Solid Antiperspirant Deodorant Coconut Lime Aluminum Chlorohydrate STICK TOPICAL 20040201 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 20 g/100g E 20171231 10237-852_5fb22720-aaa9-3fee-e053-2991aa0abbbd 10237-852 HUMAN OTC DRUG Arrid Extra Extra Dry Regular Aluminum Zirconium STICK TOPICAL 20150109 OTC MONOGRAPH FINAL part350 Arrid Extra Extra Dry ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g N 20181231 10237-855_232f599d-2a8c-07e4-e054-00144ff88e88 10237-855 HUMAN OTC DRUG Arrid Extra Extra Unscented Solid Aluminum Zirconium STICK TOPICAL 20151029 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g N 20181231 10237-856_23944a14-ba97-0fb8-e054-00144ff88e88 10237-856 HUMAN OTC DRUG Arrid Extra Extra Dry Ultra Fresh Aluminum Zirconium STICK TOPICAL 20151102 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g N 20181231 10237-857_23cd3815-9b72-4be1-e054-00144ff88e88 10237-857 HUMAN OTC DRUG Arrid Extra Extra Dry Cool Shower Aluminum Zirconium STICK TOPICAL 20151105 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g N 20181231 10237-859_241ec636-763f-1ae9-e054-00144ff8d46c 10237-859 HUMAN OTC DRUG Arrid Extra Extra Dry Ultra Fresh Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151109 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE .246 g/g E 20171231 10237-864_28c56827-dd1a-2762-e054-00144ff8d46c 10237-864 HUMAN OTC DRUG Arrid Extra Extra Dry Sport Aluminum Chlorohydrate 24.6% AEROSOL, SPRAY TOPICAL 20160108 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 24.6 g/g N 20181231 10237-900_3c8fd1f1-f2f1-40ca-9403-3f231a40ca97 10237-900 HUMAN OTC DRUG UltraMax Roll On Antiperspirant Deodorant Powder Fresh Aluminum Zirconium Tetrachlorohydrex Gly LIQUID TOPICAL 20000728 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 21 g/100mL E 20171231 10237-901_de45822e-ad74-4c22-8580-f91678082a83 10237-901 HUMAN OTC DRUG ARRID XX Roll On Antiperspirant Deodorant Regular Aluminum Chlorohydrate LIQUID TOPICAL 19960716 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE 16 mL/100mL N 20181231 10237-902_730ac944-ab19-44cd-bb1e-84ee655679f2 10237-902 HUMAN OTC DRUG ARRID Extra Dry Antiperspirant Deodorant Aluminum Sesquichlorohydrate 17% CREAM TOPICAL 19951108 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM SESQUICHLOROHYDRATE 170 mg/g N 20181231 10237-903_f026645d-01bd-4737-a70c-c9f67a8cac4c 10237-903 HUMAN OTC DRUG Baby Orajel Naturals for Teething Pain Relief Calcarea phosphorica, Coffea cruda, Chamomilla TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20110615 UNAPPROVED HOMEOPATHIC Church & Dwight Co., Inc. TRIBASIC CALCIUM PHOSPHATE; ARABICA COFFEE BEAN; MATRICARIA RECUTITA 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 10237-906_cf00d122-5e7c-4efd-8446-0c5b22f51f19 10237-906 HUMAN OTC DRUG Carters Little Pills Sodium-Free Bisacodyl TABLET, DELAYED RELEASE ORAL 20110601 OTC MONOGRAPH NOT FINAL part334 Church & Dwight Co., Inc. BISACODYL 5 mg/1 E 20171231 10237-907_58b11150-fa0f-37b7-e053-2991aa0aba39 10237-907 HUMAN OTC DRUG Legatrin PM Acetaminophen, Diphenhydramine HCI TABLET ORAL 20141001 OTC MONOGRAPH NOT FINAL part343 Church & Dwight Co., Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 50 1/1; 1/1 N 20181231 10237-908_26545e80-8c0d-2424-e054-00144ff88e88 10237-908 HUMAN OTC DRUG Baby Orajel Naturals Calceria carbonica, Calceria phosphorica, Chamomilla, Coffea cruda, Passiflora incarnata, Terebinthina TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20160118 UNAPPROVED HOMEOPATHIC Church & Dwight Co., Inc. PASSIFLORA INCARNATA FLOWERING TOP; TURPENTINE OIL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; TRIBASIC CALCIUM PHOSPHATE 6; 7; 12; 6; 6; 12 1/[hp_X]; 1/[hp_X]; 1/[hp_X]; 1/[hp_X]; 1/[hp_X]; 1/[hp_X] N 20181231 10237-909_21714d36-5b8c-3124-e054-00144ff8d46c 10237-909 HUMAN OTC DRUG Orajel Anticavity Fluoride Rinse Alcohol and Sugar Free Sodium Fluoride LIQUID DENTAL 20151005 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 10237-910_3100479f-d488-6052-e054-00144ff8d46c 10237-910 HUMAN OTC DRUG Orajel Anticavity Fluoride Rinse Alcohol and Sugar Free Sodium Fluoride LIQUID DENTAL 20151005 OTC MONOGRAPH FINAL part355 Church & Dwight Co., Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 10237-920_6153cd89-4239-93ed-e053-2991aa0a8085 10237-920 HUMAN OTC DRUG ARRID Dry invigorate Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151009 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE .194 g/g N 20181231 10237-921_6153cd89-4239-93ed-e053-2991aa0a8085 10237-921 HUMAN OTC DRUG ARRID Dry Renew Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151009 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE .194 g/g N 20181231 10237-922_6153cd89-4246-93ed-e053-2991aa0a8085 10237-922 HUMAN OTC DRUG Ultra Max Dry Confidence Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151009 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE .194 g/g N 20181231 10237-923_6153cd89-4246-93ed-e053-2991aa0a8085 10237-923 HUMAN OTC DRUG Ultra Max Dry Peak Performance Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151009 OTC MONOGRAPH FINAL part350 Church & Dwight Co., Inc. ALUMINUM CHLOROHYDRATE .194 g/g N 20181231 10252-001_331324e1-f63e-42ed-b6b2-c0620b37da6c 10252-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205849 Coastal Welding Supply, Inc. OXYGEN 990 mL/L N 20181231 10252-002_19f5a929-7328-42fe-b616-d4b4a08996fc 10252-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205850 Coastal Welding Supply, Inc. NITROGEN 990 mL/L N 20181231 10258-101_4b6ee5cf-1250-4206-98ca-ee227fa9af4d 10258-101 HUMAN OTC DRUG OXYGENETIX OXYGENATING FOUNDATION ACNE CONTROL SALICYLIC ACID LOTION TOPICAL 20141221 OTC MONOGRAPH FINAL part333D COLONIAL DAMES CO LTD SALICYLIC ACID 2 g/100mL E 20171231 10258-102_2b59d156-929b-47fc-aa3e-1a094e9d656e 10258-102 HUMAN OTC DRUG DR. KARRS ACNE-STATIN SALICYLIC ACID CREAM TOPICAL 20141221 OTC MONOGRAPH FINAL part333D COLONIAL DAMES CO LTD SALICYLIC ACID .5 g/100mL E 20171231 10267-0617_389e925e-b973-4bfb-91fb-c06312ccf0e9 10267-0617 HUMAN OTC DRUG APAP Extra Strength Acetaminophen CAPSULE ORAL 20010129 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacal Corp ACETAMINOPHEN 500 mg/1 N 20181231 10267-0835_5fa1d326-c82a-4f60-b204-b209e082f862 10267-0835 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl TABLET ORAL 20040101 OTC MONOGRAPH NOT FINAL part336 Contract Pharmacal Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 10267-0836_5fa1d326-c82a-4f60-b204-b209e082f862 10267-0836 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl TABLET ORAL 20040101 OTC MONOGRAPH NOT FINAL part336 Contract Pharmacal Corp DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 10267-3846_5fb24a6e-8575-93cd-e053-2a91aa0a7eaf 10267-3846 HUMAN OTC DRUG ibuprofen ibuprofen TABLET ORAL 20140115 ANDA ANDA071265 Contract Pharmacal Corp. IBUPROFEN 200 mg/1 N 20181231 10267-3852_5fb24a6e-8575-93cd-e053-2a91aa0a7eaf 10267-3852 HUMAN OTC DRUG ibuprofen ibuprofen TABLET ORAL 20140115 ANDA ANDA071265 Contract Pharmacal Corp. IBUPROFEN 200 mg/1 N 20181231 10267-3909_5fb24a6e-8575-93cd-e053-2a91aa0a7eaf 10267-3909 HUMAN OTC DRUG ibuprofen ibuprofen TABLET ORAL 20140115 ANDA ANDA071265 Contract Pharmacal Corp. IBUPROFEN 200 mg/1 N 20181231 10271-101_2a4be57a-a3df-4aa5-be52-845b75e78b3b 10271-101 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate INJECTION SUBCUTANEOUS 20141215 ANDA ANDA200122 United Biomedical Inc., Asia TERBUTALINE SULFATE 1 mg/mL N 20181231 10279-160_3ec5ac31-4b53-3be7-e054-00144ff88e88 10279-160 HUMAN OTC DRUG KORRES SUNCARE YOGHURT NOURISHING FLUID VEIL FACE SUNSCREEN BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20141224 20180831 OTC MONOGRAPH NOT FINAL part352 Korres S.A. - Natural Products AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 150; 65; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 10297-001_502b6481-b065-4e32-9ea5-9bf99897bebd 10297-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19780102 NDA NDA205737 A OX Welding Supply Company Inc. OXYGEN 990 mL/L N 20181231 10297-002_bcaa144b-8b99-4ebf-93d6-c935d8b7d18f 10297-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20120109 NDA NDA205738 A OX Welding Supply Company Inc. NITROGEN 990 mL/L N 20181231 10297-003_f4cc8fe9-cdf0-4527-9010-09869f03118b 10297-003 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20150311 UNAPPROVED MEDICAL GAS A OX Welding Supply Company Inc. AIR 1000 mL/L E 20171231 10297-004_7eca84e7-775b-4c22-b3a9-1ae936fa64ef 10297-004 HUMAN PRESCRIPTION DRUG Air 90% Carbon Dioxide 10% Air 90% Carbon Dioxide 10% GAS RESPIRATORY (INHALATION) 20150311 NDA NDA205846 A-OX WELDING SUPPLY CO., INC. CARBON DIOXIDE 100 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 10297-005_60c7b379-d05a-bd4e-e053-2a91aa0afbfd 10297-005 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20150311 NDA NDA205889 A-OX Welding Supply Co., Inc. OXYGEN 210 mL/L N 20181231 10304-463_41b1e400-ee5d-48b6-9132-afe97a155f74 10304-463 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000612 NDA NDA205865 Delille Oxygen Company OXYGEN 995 mL/L N 20181231 10304-601_a9e5f633-cf30-4e0b-898e-22f7a927aa93 10304-601 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20000612 NDA NDA205866 Delille Oxygen Company NITROGEN 999 mL/L N 20181231 10337-061_af011455-7a16-46eb-9823-42ca3abdbc98 10337-061 HUMAN PRESCRIPTION DRUG Pamine methscopolamine bromide TABLET ORAL 19530409 NDA NDA008848 PharmaDerm a division of Fougera Pharmaceuticals Inc. METHSCOPOLAMINE BROMIDE 2.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 10337-062_af011455-7a16-46eb-9823-42ca3abdbc98 10337-062 HUMAN PRESCRIPTION DRUG Pamine Forte methscopolamine bromide TABLET ORAL 20030325 NDA NDA008848 PharmaDerm a division of Fougera Pharmaceuticals Inc. METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 10337-153_05460f8a-bc79-428d-a26a-7470df536d3e 10337-153 HUMAN PRESCRIPTION DRUG PANDEL HYDROCORTISONE PROBUTATE CREAM TOPICAL 19970228 NDA NDA020453 PharmaDerm a division of Fougera Pharmaceuticals Inc. HYDROCORTISONE PROBUTATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10337-162_d53bf693-775c-4856-a086-63b17657754c 10337-162 HUMAN PRESCRIPTION DRUG Temovate clobetasol propionate OINTMENT TOPICAL 19960223 ANDA ANDA074407 PharmaDerm, A division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 10337-163_d53bf693-775c-4856-a086-63b17657754c 10337-163 HUMAN PRESCRIPTION DRUG Temovate clobetasol propionate CREAM TOPICAL 19960930 ANDA ANDA074392 PharmaDerm, A division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 10337-301_ee16de89-1d93-43cb-9c93-2eab26bf180e 10337-301 HUMAN PRESCRIPTION DRUG TEMOVATE E clobetasol propionate CREAM TOPICAL 19990526 ANDA ANDA075430 PharmaDerm a division of Fougera Pharmaceuticals Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10337-311_645d51d4-1785-48e1-8aff-53a6e69ec06a 10337-311 HUMAN OTC DRUG ENTSOL Sodium Chloride SPRAY NASAL 20000901 UNAPPROVED DRUG OTHER PharmaDerm, A division of Fougera Pharmaceuticals Inc. SODIUM CHLORIDE 30 mg/mL N 20181231 10337-332_f7aca819-cbbd-46c5-8010-340396035a8e 10337-332 HUMAN PRESCRIPTION DRUG Cutivate fluticasone propionate CREAM TOPICAL 19901218 NDA NDA019958 PharmaDerm a division of Fougera Pharmaceuticals Inc. FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10337-333_70117b00-bf59-4e0f-a0e6-262355ecf637 10337-333 HUMAN PRESCRIPTION DRUG Cutivate fluticasone propionate OINTMENT TOPICAL 20091214 NDA NDA019957 PharmaDerm, A division of Fougera Pharmaceuticals Inc. FLUTICASONE PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10337-358_7db1fb44-d057-4eb9-8036-ad323de3ee08 10337-358 HUMAN PRESCRIPTION DRUG Oxistat oxiconazole nitrate CREAM TOPICAL 19881230 NDA NDA019828 PharmaDerm a division of Fougera Pharmaceuticals Inc. OXICONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 10337-359_7db1fb44-d057-4eb9-8036-ad323de3ee08 10337-359 HUMAN PRESCRIPTION DRUG Oxistat oxiconazole nitrate LOTION TOPICAL 19920930 NDA NDA020209 PharmaDerm a division of Fougera Pharmaceuticals Inc. OXICONAZOLE NITRATE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 10337-395_d7085534-294c-4523-b961-ca3adc4ecad8 10337-395 HUMAN PRESCRIPTION DRUG ApexiCon E diflorasone diacetate CREAM TOPICAL 20021220 ANDA ANDA076263 PharmaDerm a division of Fougera Pharmaceuticals Inc. DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10337-434_001229b5-d94e-403b-b145-f94a6d13354c 10337-434 HUMAN PRESCRIPTION DRUG Cutivate fluticasone propionate LOTION TOPICAL 20091005 NDA NDA021152 PharmaDerm a division of Fougera Pharmaceuticals Inc. FLUTICASONE PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10337-450_d34b239e-d49e-4008-bfaa-4fc78c8998bd 10337-450 HUMAN PRESCRIPTION DRUG Veregen sinecatechins OINTMENT TOPICAL 20071214 NDA NDA021902 PharmaDerm a division of Fougera Pharmaceuticals Inc. SINECATECHINS 150 mg/g N 20181231 10337-803_1b521631-02df-447f-bfcc-1556606b652e 10337-803 HUMAN PRESCRIPTION DRUG Solaraze diclofenac sodium GEL TOPICAL 20001016 NDA NDA021005 PharmaDerm a division of Fougera Pharmaceuticals Inc. DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 10337-804_6c476a28-fba8-4e11-9f39-ceca33f3a76c 10337-804 HUMAN PRESCRIPTION DRUG Zonalon doxepin hydrochloride CREAM TOPICAL 19940401 NDA NDA020126 PharmaDerm A division of Fougera Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE 50 mg/g Tricyclic Antidepressant [EPC] N 20181231 10337-815_26b9e8bd-a1aa-4293-aacc-927cc75149c5 10337-815 HUMAN PRESCRIPTION DRUG Adoxa doxycycline CAPSULE ORAL 20110601 ANDA ANDA065055 PharmaDerm a division of Fougera Pharmaceuticals Inc. DOXYCYCLINE 150 mg/1 N 20181231 10337-844_61b24af9-65f4-4bd4-a777-35681d684f3a 10337-844 HUMAN PRESCRIPTION DRUG Solaraze diclofenac sodium GEL TOPICAL 20001016 NDA NDA021005 PharmaDerm a division of Fougera Pharmaceuticals Inc. DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 10337-905_f5cf95a3-df25-4518-8609-95b45aa3711f 10337-905 HUMAN PRESCRIPTION DRUG Kerydin Tavaborole SOLUTION TOPICAL 20140707 NDA NDA204427 PharmaDerm, A division of Fougera Pharmaceuticals Inc. TAVABOROLE 43.5 mg/mL Oxaborole Antifungal [EPC],Protein Synthesis Inhibitors [MoA],Boron Compounds [Chemical/Ingredient] N 20181231 10345-900_60e015a1-88de-49e5-e053-2a91aa0a2ed0 10345-900 HUMAN OTC DRUG ERBORIAN - BB CREME AU GINSENG CLAIR SPF 20 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150206 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 30; 62.8; 19.2 mg/mL; mg/mL; mg/mL N 20181231 10345-901_60e00496-3a8a-32af-e053-2a91aa0a99d2 10345-901 HUMAN OTC DRUG ERBORIAN - BB CREME AU GINSENG DORE SPF 20 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150206 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 30; 62.8; 19.2 mg/mL; mg/mL; mg/mL N 20181231 10345-902_60dffcff-2c79-02bc-e053-2991aa0afbf2 10345-902 HUMAN OTC DRUG ERBORIAN - BB CREME NUDE SPF20 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 30; 62.8; 19.2 mg/mL; mg/mL; mg/mL N 20181231 10345-903_60e015a1-88f1-49e5-e053-2a91aa0a2ed0 10345-903 HUMAN OTC DRUG ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20161216 OTC MONOGRAPH FINAL part352 LABORATOIRES M&L OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 30; 62.8; 19.2 mg/mL; mg/mL; mg/mL N 20181231 10345-910_5fc20848-3a93-0e95-e053-2991aa0a3ee4 10345-910 HUMAN OTC DRUG ERBORIAN - CC CREME HIGH DEFINITION SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150206 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 60; 20; 49.7; 19.2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10345-911_6051c98e-a376-1543-e053-2a91aa0aa019 10345-911 HUMAN OTC DRUG ERBORIAN - CC CREME HIGH DEFINITION SPF25 CLAIR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20160713 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 60; 20; 43.3; 19.2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10345-921_60e0141f-178f-20b8-e053-2991aa0a596f 10345-921 HUMAN OTC DRUG ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE KIT 20171203 OTC MONOGRAPH NOT FINAL part352 LABORATOIRES M&L N 20181231 10348-001_06fd9e72-8f61-423f-9d3b-91044b198794 10348-001 HUMAN OTC DRUG STUDIO SKIN 15 HOUR WEAR FOUNDATION SPF10 TITANIUM DIOXIDE LIQUID TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC TITANIUM DIOXIDE 4.7 mL/100mL E 20171231 10348-002_94e364ba-9e7c-41f8-864d-dd3d70b2f24b 10348-002 HUMAN OTC DRUG CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 OCTINOXlATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 4; 2.5; 1.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 10348-003_886d9244-2d86-4538-9d4a-e799f7e19dc4 10348-003 HUMAN OTC DRUG SHEER FOCUS TINTED MOISTURIZER OCTINOXATE and ZINC OXIDE LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; ZINC OXIDE 7; 2.8 mL/100mL; mL/100mL N 20181231 10348-004_914e2639-b8ad-40a3-9843-035cfab7f440 10348-004 HUMAN OTC DRUG smashbox PHOTO FINISH SPF 15 FOUNDATION PRIMER OCTINOXATE and OCTISALATE LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; OCTISALATE 7.5; 5 mL/100mL; mL/100mL N 20181231 10348-005_bef1a480-50b1-4c28-aa23-20a828184a76 10348-005 HUMAN OTC DRUG SMASHBOX HIGH DEFINITION HEALTHY FX FOUNDATION SPF 15 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; TITANIUM DIOXIDE 5; 3.2 mL/100mL; mL/100mL N 20181231 10348-006_aadd2583-2171-45f4-84b9-72aba03a4569 10348-006 HUMAN OTC DRUG SMASHBOX PHOTO FINISH FOUNDATION PRIMER SPF 20 AVOBENZONE, HOMOSALATE, and OCTISALATE LIQUID TOPICAL 20120527 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC AVOBENZONE; HOMOSALATE; OCTISALATE 2; 15; 5 mL/100mL; mL/100mL; mL/100mL N 20181231 10348-008_ad8f88b4-d06b-4d59-9e5d-c7abe28a8e51 10348-008 HUMAN OTC DRUG PHOTO FINISH MORE THAN PRIMER BLEMISH CONTROL SALICYLIC ACID CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part333D SMASHBOX BEAUTY COSMETICS, INC SALICYLIC ACID .02 g/mL N 20181231 10348-010_5dc69a7f-688f-4fd7-b156-e0f4a4ea54b6 10348-010 HUMAN OTC DRUG HALO HD FOUNDATION BROAD SPECTRUM SPF 15 OIL FREE OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; TITANIUM DIOXIDE .05635; .03335 g/100mL; g/100mL N 20181231 10348-011_33cabee0-6adc-4cd9-9e14-c8b161e806ec 10348-011 HUMAN OTC DRUG CAMERA READY BB EYES BS SPF 15 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130920 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .04592; .01568; .0168 g/100mL; g/100mL; g/100mL N 20181231 10348-012_4f3dc900-9320-44fd-8824-d5de52d795fb 10348-012 HUMAN OTC DRUG CAMERA READY BB WATER BROAD SPECTRUM SPF 30 Octinoxate, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20150406 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .056; .03472; .02352 g/100mL; g/100mL; g/100mL N 20181231 10348-014_cd65cbe2-2569-4506-bf9e-0ada0a9e280b 10348-014 HUMAN OTC DRUG CAMERA READY CC BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SMASHBOX BEAUTY COSMETICS, INC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .08175; .0436; .02725; .0119 g/mL; g/mL; g/mL; g/mL N 20181231 10356-100_5c7575ea-6e07-6194-e053-2a91aa0a2bed 10356-100 HUMAN OTC DRUG Aquaphor Original Petrolatum OINTMENT TOPICAL 19750601 OTC MONOGRAPH FINAL part347 Beiersdorf Inc PETROLATUM 41 g/100g N 20181231 10356-101_63f13861-33c6-2103-e053-2a91aa0a139f 10356-101 HUMAN OTC DRUG Aquaphor Healing Petrolatum OINTMENT TOPICAL 19910101 OTC MONOGRAPH FINAL part347 Beiersdorf Inc PETROLATUM 41 g/100g N 20191231 10356-105_4288afe8-5252-1386-e054-00144ff8d46c 10356-105 HUMAN OTC DRUG Aquaphor Healing Diaper Rash Zinc Oxide CREAM TOPICAL 20150130 OTC MONOGRAPH FINAL part347 Beiersdorf Inc ZINC OXIDE 15 g/100g N 20181231 10356-111_63f6df7f-911e-02d8-e053-2991aa0a97af 10356-111 HUMAN OTC DRUG Aquaphor Lip Protectant and Sunscreen Petrolatum, Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20150630 OTC MONOGRAPH FINAL part347 Beiersdorf Inc PETROLATUM; AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 31; 3; 6.75; 4.5; 2; 5.4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20191231 10356-115_4a702736-f8cf-1cf2-e054-00144ff8d46c 10356-115 HUMAN OTC DRUG Aquaphor Healing Fast Relief Diaper Rash Zinc Oxide OINTMENT TOPICAL 20170331 OTC MONOGRAPH FINAL part347 Beiersdorf Inc ZINC OXIDE 40 g/100g N 20181231 10356-323_8a9ff747-afce-4c48-9ac6-5c77d0aeafcf 10356-323 HUMAN OTC DRUG Eucerin Daily Protection Face Ensulizole, Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20150812 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc ENSULIZOLE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2; 7.5; 4.5; 2.4; 4.8 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 10356-327_cdbf9a73-0fa8-4a9d-83b5-3477df231c79 10356-327 HUMAN OTC DRUG Eucerin Daily Protection Body Homosalate, Octinoxate, Octisalate, Titanium Dioxide LOTION TOPICAL 20090104 20180930 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc HOMOSALATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 5; 5; 4; 1 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 10356-328_24c1918b-3f9a-4cba-95ae-21681a66e171 10356-328 HUMAN OTC DRUG Eucerin Daily Hydration Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 3.4; 3.4; 4.7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 10356-331_f84b7bbb-b0ba-43fa-928a-313ebc263b3c 10356-331 HUMAN OTC DRUG Eucerin Daily Hydration Hand Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 3; 4; 9 g/100g; g/100g; g/100g; g/100g N 20181231 10356-335_672209f2-b502-4e00-aeb1-1cc6aa7cc22d 10356-335 HUMAN OTC DRUG Eucerin Daily Hydration Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 9 g/100g; g/100g; g/100g; g/100g N 20181231 10356-340_cfc70156-fffd-4538-9811-0e5add3e687e 10356-340 HUMAN OTC DRUG Eucerin Q10 Anti-Wrinkle Sensitive Skin Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20010102 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 3; 3 g/100mL; g/100mL; g/100mL N 20181231 10356-352_6ea1617c-87be-4678-97a7-2724c90bc82d 10356-352 HUMAN OTC DRUG Eucerin Redness Relief Daily Perfecting Octinoxate, Octisalate, Titanium Dioxide LOTION TOPICAL 20090102 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 5; 4 g/100mL; g/100mL; g/100mL N 20181231 10356-353_4b7fa7a4-8fe3-15c1-e054-00144ff88e88 10356-353 HUMAN OTC DRUG Eucerin Redness Relief Daily Perfecting Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20170330 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE 4.5; 3.5; 2; 3.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 10356-355_437e16b6-7010-4684-e054-00144ff8d46c 10356-355 HUMAN OTC DRUG Eucerin Calming Itch Relief Treatment Menthol LOTION TOPICAL 20070102 20181130 OTC MONOGRAPH NOT FINAL part348 Beiersdorf Inc MENTHOL .1 g/100mL N 20181231 10356-356_43082dcb-3f01-6857-e054-00144ff88e88 10356-356 HUMAN OTC DRUG Eucerin Skin Calming Menthol LOTION TOPICAL 20161115 OTC MONOGRAPH NOT FINAL part348 Beiersdorf Inc MENTHOL .1 g/100mL N 20181231 10356-365_5df7d5f1-9926-b245-e053-2991aa0a0d24 10356-365 HUMAN OTC DRUG Eucerin Eczema Relief Body Oatmeal CREAM TOPICAL 20130715 OTC MONOGRAPH FINAL part347 Beiersdorf Inc OATMEAL 1 g/100g N 20181231 10356-371_5df8ea40-e299-dff6-e053-2991aa0aa09a 10356-371 HUMAN OTC DRUG Eucerin Eczema Relief Flare Up Treatment Oatmeal CREAM TOPICAL 20150608 OTC MONOGRAPH FINAL part347 Beiersdorf Inc OATMEAL 1 g/100g N 20181231 10356-375_4b68565d-4c17-16d8-e054-00144ff88e88 10356-375 HUMAN OTC DRUG Eucerin Eczema Relief Hand Oatmeal CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part347 Beiersdorf Inc OATMEAL 1 g/100g N 20181231 10356-566_49256e44-4e5b-133f-e054-00144ff88e88 10356-566 HUMAN OTC DRUG Nivea Men Protective Avobenzone, Octisalate, Octocrylene LOTION TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 4.7; 8.4 g/100mL; g/100mL; g/100mL N 20181231 10356-572_5e07f26f-cfa8-57f9-e053-2991aa0a2008 10356-572 HUMAN OTC DRUG Nivea Men Energy Revitalizing Avobenzone, Octisalate, Octocrylene LOTION TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 4.7; 8.4 g/100mL; g/100mL; g/100mL N 20181231 10356-575_9e584e9c-d64a-490a-b6db-aae53d3454b5 10356-575 HUMAN OTC DRUG Nivea Men Sensitive Protective Avobenzone, Octisalate, Octocrylene LOTION TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 4.7; 8.4 g/100mL; g/100mL; g/100mL N 20181231 10356-818_64282cf8-0f18-15a2-e053-2991aa0a2644 10356-818 HUMAN OTC DRUG Nivea Smoothness Lip Care Avobenzone, Octinoxate, Octocrylene STICK TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE; OCTOCRYLENE 2.5; 6; 1.8 g/100g; g/100g; g/100g N 20191231 10356-823_5df97283-7941-895f-e053-2991aa0a8ca3 10356-823 HUMAN OTC DRUG Nivea Recovery Medicated Lip Care Dimethicone, Avobenzone, Octinoxate, Octocrylene STICK TOPICAL 20151101 OTC MONOGRAPH FINAL part347 Beiersdorf Inc DIMETHICONE; AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.2; 2.5; 6; 1.8 g/100g; g/100g; g/100g; g/100g N 20181231 10356-845_a667b1d6-561d-4723-9815-cf186f75547f 10356-845 HUMAN OTC DRUG Nivea A Kiss of Shine Natural Look Glossy Lip Care Avobenzone, Octinoxate LOTION TOPICAL 20110204 OTC MONOGRAPH NOT FINAL part352 Beiersdorf Inc AVOBENZONE; OCTINOXATE .027; .0675 mL/mL; mL/mL E 20171231 10356-855_5d8749de-9484-484f-b96b-23160f798a70 10356-855 HUMAN OTC DRUG Nivea A Kiss of Intense Moisture Healing Medicated Lip Care Menthol, Petrolatum LOTION TOPICAL 20110214 OTC MONOGRAPH FINAL part347 Beiersdorf Inc MENTHOL; PETROLATUM .006; .31 mL/mL; mL/mL E 20171231 10358-1417_20df91c8-0e11-465a-b810-0e7a5c9a2785 10358-1417 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS NASAL; RESPIRATORY (INHALATION) 20040818 UNAPPROVED MEDICAL GAS AIRSENSE INC OXYGEN 995 mL/L E 20171231 10361-778_f8b4bb0b-dadf-7c61-51dd-6c4e0e98ade1 10361-778 HUMAN PRESCRIPTION DRUG E-Z-Disk barium sulfate TABLET ORAL 20090201 UNAPPROVED DRUG OTHER E-Z-EM, INC. BARIUM SULFATE 700 mg/1 Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 10370-101_ec0aeb2e-8ba4-4189-aec3-318b8ee49378 10370-101 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 Par Pharmaceutical, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 10370-102_ec0aeb2e-8ba4-4189-aec3-318b8ee49378 10370-102 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 Par Pharmaceutical, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 10370-116_f4f1dd2f-8493-46b6-97b8-223704b7c105 10370-116 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Extended-Release Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111206 ANDA ANDA078148 Par Pharmaceutical, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 10370-117_f4f1dd2f-8493-46b6-97b8-223704b7c105 10370-117 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Extended-Release Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078148 Par Pharmaceutical, Inc. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 10370-169_2a77502d-c2bf-4f3d-81c0-7f227ef4bfa1 10370-169 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130319 ANDA ANDA202010 Par Pharmaceutical, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 10370-170_0b87676b-9f51-437e-af66-edb1cba050ab 10370-170 HUMAN PRESCRIPTION DRUG Darifenacin Hydrobromide Extended-Release Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20160315 ANDA ANDA091190 Par Pharmaceutical, Inc. DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 10370-171_0b87676b-9f51-437e-af66-edb1cba050ab 10370-171 HUMAN PRESCRIPTION DRUG Darifenacin Hydrobromide Extended-Release Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20160315 ANDA ANDA091190 Par Pharmaceutical, Inc. DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 10370-175_727c807e-27de-4403-843d-417c2013993c 10370-175 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE ORAL 20130313 ANDA ANDA091476 Par Pharmaceutical, Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 10370-176_727c807e-27de-4403-843d-417c2013993c 10370-176 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE ORAL 20130313 ANDA ANDA091476 Par Pharmaceutical, Inc. FLUVOXAMINE MALEATE 150 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 10370-190_03dd4cc0-9f63-4ba2-94e5-3c3abd214e52 10370-190 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150702 20190131 ANDA ANDA076467 Par Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 10370-191_03dd4cc0-9f63-4ba2-94e5-3c3abd214e52 10370-191 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150702 20190131 ANDA ANDA076467 Par Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 10370-195_397470a1-b152-488d-bdd6-a582a0256c82 10370-195 HUMAN PRESCRIPTION DRUG levetiracetam extended-release levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111004 ANDA ANDA091360 Anchen Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 10370-209_c67613ea-a237-4e5b-bb68-b511d023d1da 10370-209 HUMAN PRESCRIPTION DRUG Fenofibric Acid Delayed-Release Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20130718 ANDA ANDA201573 Par Pharmaceutical, Inc. CHOLINE FENOFIBRATE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 10370-210_c67613ea-a237-4e5b-bb68-b511d023d1da 10370-210 HUMAN PRESCRIPTION DRUG Fenofibric Acid Delayed-Release Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20130718 ANDA ANDA201573 Par Pharmaceutical, Inc. CHOLINE FENOFIBRATE 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 10370-214_397470a1-b152-488d-bdd6-a582a0256c82 10370-214 HUMAN PRESCRIPTION DRUG levetiracetam extended-release levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111004 ANDA ANDA091360 Anchen Pharmaceuticals, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 10370-219_4f4bc944-e9f3-46bf-919e-0bdd4bb9b34a 10370-219 HUMAN PRESCRIPTION DRUG Potassium Chloride Extended-Release Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20131226 20190930 ANDA ANDA202886 Par Pharmaceutical, Inc. POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 10370-220_4f4bc944-e9f3-46bf-919e-0bdd4bb9b34a 10370-220 HUMAN PRESCRIPTION DRUG Potassium Chloride Extended-Release Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20131226 20200131 ANDA ANDA202886 Par Pharmaceutical, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 10370-221_b2f7dc6f-1fd2-4300-8453-aadbe1c6cbf0 10370-221 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride tramadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120627 ANDA ANDA200491 Par Pharmaceutical, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 10370-222_b2f7dc6f-1fd2-4300-8453-aadbe1c6cbf0 10370-222 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120627 ANDA ANDA200491 Par Pharmaceutical, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 10370-223_b2f7dc6f-1fd2-4300-8453-aadbe1c6cbf0 10370-223 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120627 ANDA ANDA200491 Par Pharmaceutical, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 10370-251_69f84050-3b0b-41f4-8f19-73e3671b9971 10370-251 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole TABLET, EXTENDED RELEASE ORAL 20150422 ANDA ANDA202206 Par Pharmaceutical, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .375 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 10370-252_69f84050-3b0b-41f4-8f19-73e3671b9971 10370-252 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole TABLET, EXTENDED RELEASE ORAL 20150209 ANDA ANDA202206 Par Pharmaceutical, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 10370-253_69f84050-3b0b-41f4-8f19-73e3671b9971 10370-253 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole TABLET, EXTENDED RELEASE ORAL 20150209 ANDA ANDA202206 Par Pharmaceutical, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 10370-254_69f84050-3b0b-41f4-8f19-73e3671b9971 10370-254 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole TABLET, EXTENDED RELEASE ORAL 20150720 ANDA ANDA202206 Par Pharmaceutical, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 10370-255_69f84050-3b0b-41f4-8f19-73e3671b9971 10370-255 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole TABLET, EXTENDED RELEASE ORAL 20160705 ANDA ANDA202206 Par Pharmaceutical, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 4.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 10370-257_97fe07e4-729a-4538-a6be-adee45d97596 10370-257 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Extended-Release Clonidine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130930 ANDA ANDA202984 Par Pharmaceutical, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 10370-268_a3f53b5e-8c97-4d1d-be93-f09c740cc803 10370-268 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CAPSULE ORAL 20121024 ANDA ANDA201687 Par Pharmaceutical, Inc. TRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 10370-280_73c8738d-9856-4fd0-80a9-4a2f371341df 10370-280 HUMAN PRESCRIPTION DRUG Dutasteride and Tamsulosin Hydrochloride Dutasteride and Tamsulosin Hydrochloride Capsules CAPSULE ORAL 20151118 ANDA ANDA202509 Par Pharmaceutical, Inc. DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE .5; .4 mg/1; mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA],Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 10370-302_97fe07e4-729a-4538-a6be-adee45d97596 10370-302 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Extended-Release Clonidine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130930 ANDA ANDA202984 Par Pharmaceutical, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 10370-305_69f84050-3b0b-41f4-8f19-73e3671b9971 10370-305 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole TABLET, EXTENDED RELEASE ORAL 20151120 ANDA ANDA202206 Par Pharmaceutical, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 2.25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 10370-306_69f84050-3b0b-41f4-8f19-73e3671b9971 10370-306 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole TABLET, EXTENDED RELEASE ORAL 20160705 ANDA ANDA202206 Par Pharmaceutical, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 3.75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 10370-510_1b395fed-8b7e-4d91-8d26-95035df22999 10370-510 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20090226 ANDA ANDA078445 Par Pharmaceutical, Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 10370-511_1b395fed-8b7e-4d91-8d26-95035df22999 10370-511 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078445 Par Pharmaceutical, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 10370-533_43019d8e-f710-491d-8fe6-3681c75b6d76 10370-533 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20150602 ANDA ANDA201408 Par Pharmaceutical Inc. GUANFACINE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 10370-534_43019d8e-f710-491d-8fe6-3681c75b6d76 10370-534 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20150602 ANDA ANDA201408 Par Pharmaceutical Inc. GUANFACINE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 10370-536_43019d8e-f710-491d-8fe6-3681c75b6d76 10370-536 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20150602 ANDA ANDA201408 Par Pharmaceutical Inc. GUANFACINE 3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 10370-538_43019d8e-f710-491d-8fe6-3681c75b6d76 10370-538 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20150602 ANDA ANDA201408 Par Pharmaceutical Inc. GUANFACINE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 10370-677_1e116ab3-4b77-4815-a9b6-0593dba5fc56 10370-677 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160302 ANDA ANDA077899 Par Pharmaceutical, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 10370-678_1e116ab3-4b77-4815-a9b6-0593dba5fc56 10370-678 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160302 ANDA ANDA077899 Par Pharmaceutical, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 10370-679_1e116ab3-4b77-4815-a9b6-0593dba5fc56 10370-679 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160302 ANDA ANDA077899 Par Pharmaceutical, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 10370-745_a69666d6-6655-4648-a8fc-12ca0f62bd73 10370-745 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161221 ANDA ANDA076159 Par Pharmaceutical, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 10370-746_a69666d6-6655-4648-a8fc-12ca0f62bd73 10370-746 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161221 ANDA ANDA076159 Par Pharmaceutical, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 10370-829_e5159efb-83fe-4a1f-9583-ae3a4709c1ff 10370-829 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 Par Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 10370-830_e5159efb-83fe-4a1f-9583-ae3a4709c1ff 10370-830 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 Par Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 10370-831_e5159efb-83fe-4a1f-9583-ae3a4709c1ff 10370-831 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 Par Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 10370-832_e5159efb-83fe-4a1f-9583-ae3a4709c1ff 10370-832 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 Par Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 10412-0001_c40cbcf6-a060-4bd0-b6b2-1972a3c76b8b 10412-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Flint Welding Supply Company OXYGEN 99 L/100L E 20171231 10412-0095_0042d2f1-4460-48af-a52a-cc0af1aa87b6 10412-0095 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19630101 UNAPPROVED MEDICAL GAS Flint Welding Supply Company NITROGEN 99.5 L/100L E 20171231 10424-101_fb193dd0-996d-4a58-ad6f-3354555963a4 10424-101 HUMAN OTC DRUG SyAllgen PENICILLIUM GLABRUM TABLET ORAL 20150215 20191130 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM GLABRUM 250 mg/1 E 20171231 10424-102_861e2c25-c73c-44fb-9e9d-9b3350686981 10424-102 HUMAN OTC DRUG SyCircue MUCOR RACEMOSUS TABLET ORAL 20150215 20191130 UNAPPROVED HOMEOPATHIC Syntrion GmbH MUCOR RACEMOSUS 250 mg/1 E 20171231 10424-104_8e08eb24-0ac8-4fe1-b112-20f47a19e99f 10424-104 HUMAN OTC DRUG SyDetox ALOE, ACTIVATED CHARCOAL, GOLDENSEAL, STRYCHNOS NUX-VOMICA SEED, and OKOUBAKA AUBREVILLEI BARK TABLET ORAL 20141015 20190930 UNAPPROVED HOMEOPATHIC Syntrion GmbH ALOE; ACTIVATED CHARCOAL; GOLDENSEAL; STRYCHNOS NUX-VOMICA SEED; OKOUBAKA AUBREVILLEI BARK 20; 20; 20; 20; 20 mg/1; mg/1; mg/1; mg/1; mg/1 E 20171231 10424-105_20fab166-f103-4749-94a5-e3e909ac2ed8 10424-105 HUMAN OTC DRUG SyFungin CANDIDA PARAPSILOSIS TABLET ORAL 20141015 20190930 UNAPPROVED HOMEOPATHIC Syntrion GmbH CANDIDA PARAPSILOSIS 250 mg/1 E 20171231 10424-106_273c4e0b-eba4-46bc-959c-8d8bf0e57bc3 10424-106 HUMAN OTC DRUG SyGest CANDIDA PARAPSILOSIS and PENICILLIUM GLABRUM TABLET ORAL 20140110 20190831 UNAPPROVED HOMEOPATHIC Syntrion GmbH CANDIDA PARAPSILOSIS; PENICILLIUM GLABRUM 125; 125 mg/1; mg/1 E 20171231 10424-107_152bd7e9-28cc-44b1-96de-2af85d873b83 10424-107 HUMAN OTC DRUG SyImmune PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM TABLET ORAL 20140110 20190831 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 250 mg/1 E 20171231 10424-108_267c52af-4ce8-4bfa-9d16-ff5122ae5e4f 10424-108 HUMAN OTC DRUG SyInfect PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM and PENICILLIUM GLABRUM TABLET ORAL 20150215 20191130 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM 125; 125 mg/1; mg/1 E 20171231 10424-109_294b5c0a-b16c-4adb-b0f1-ce8214bd163d 10424-109 HUMAN OTC DRUG SyReflux PENICILLIUM ROQUEFORTI TABLET ORAL 20150211 20200831 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM ROQUEFORTI 250 mg/1 E 20171231 10424-110_5f644c1a-3765-4126-9d41-2bd2c7b7f4b2 10424-110 HUMAN OTC DRUG SyResp ASPERGILLUS NIGER VAR. NIGER TABLET ORAL 20150211 20200831 UNAPPROVED HOMEOPATHIC Syntrion GmbH ASPERGILLUS NIGER VAR. NIGER 250 mg/1 E 20171231 10424-156_e94b8d4b-bc32-4b56-a3b7-af768233b5d6 10424-156 HUMAN OTC DRUG SyAllgen Penicillium Glabrum TABLET ORAL 20060518 UNAPPROVED HOMEOPATHIC Syntrion GmbH PENICILLIUM GLABRUM 4 [hp_X]/1 E 20171231 10451-001_58da33d6-9b7a-47cf-b6ee-c2c51a9e3491 10451-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19690101 NDA NDA205889 General Distributing Co. OXYGEN 992 mL/L N 20181231 10451-002_f49d450e-3373-47a7-a556-1c17a1f55fc8 10451-002 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS General Distributing Company AIR 1000 mL/L E 20171231 10451-003_91003474-f2ba-4c0b-b417-b02484319d82 10451-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205891 General Distributing Company NITROGEN 992 mL/L N 20181231 10451-004_60cf5bca-1a04-fae4-e053-2a91aa0a0657 10451-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205889 General Distributing Company OXYGEN 210 mL/L N 20181231 10453-0123_fca3b6b5-3861-4869-a131-75197ae68b7e 10453-0123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040814 UNAPPROVED MEDICAL GAS Sunrise Medical Supply, Inc. dba American Medical Oxygen OXYGEN 99 L/100L E 20171231 10454-710_fe96358c-e490-47bd-b992-3783022b7aff 10454-710 HUMAN PRESCRIPTION DRUG Myobloc rimabotulinumtoxinB INJECTION, SOLUTION INTRAMUSCULAR 20001208 BLA BLA103846 Solstice Neurosciences, LLC RIMABOTULINUMTOXINB 2500 [USP'U]/.5mL Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 10454-711_fe96358c-e490-47bd-b992-3783022b7aff 10454-711 HUMAN PRESCRIPTION DRUG Myobloc rimabotulinumtoxinB INJECTION, SOLUTION INTRAMUSCULAR 20001208 BLA BLA103846 Solstice Neurosciences, LLC RIMABOTULINUMTOXINB 5000 [USP'U]/mL Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 10454-712_fe96358c-e490-47bd-b992-3783022b7aff 10454-712 HUMAN PRESCRIPTION DRUG Myobloc rimabotulinumtoxinB INJECTION, SOLUTION INTRAMUSCULAR 20001208 BLA BLA103846 Solstice Neurosciences, LLC RIMABOTULINUMTOXINB 10000 [USP'U]/2mL Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 10477-0063_972a525f-5ebd-4eff-a9f4-eded72e25687 10477-0063 HUMAN OTC DRUG Daily SPF 20 Oleander Face Cream Zinc Oxide CREAM TOPICAL 20171117 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics ZINC OXIDE 12.5 g/100g N 20181231 10477-2627_cfc06532-2c88-4de7-9c63-2cbba8f59817 10477-2627 HUMAN OTC DRUG Tinted SPF 45 Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics, LP OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 2 g/100g; g/100g; g/100g E 20171231 10477-7603_dbc52bc6-a04f-4b43-9706-aa43283c89af 10477-7603 HUMAN OTC DRUG Tinted Moisturizer Matte Broad Spectrum SPF 45 octinoxate, octisalate, titanium dioxide, zinc oxide CREAM TOPICAL 20130622 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics LP OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 5.5; 3.5; 4; 3 g/100g; g/100g; g/100g; g/100g N 20181231 10477-7720_48f59516-2997-49bb-876c-22d4bca23012 10477-7720 HUMAN OTC DRUG Daily Moisturizing Antioxidant SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate CREAM TOPICAL 20130626 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics LP AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 3; 3; 7.5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 10477-7749_32a44afd-0085-44ef-85ab-c515228837bd 10477-7749 HUMAN OTC DRUG Tinted Moisturizer Broad-Spectrum SPF 45 Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part352 Goodier Cosmetics LP OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 3.5; 3 g/100g; g/100g; g/100g; g/100g N 20181231 10477-9697_ac47ecc6-f858-4273-ae5b-632df1c87933 10477-9697 HUMAN OTC DRUG Salicylic Acid Salicylic Acid GEL TOPICAL 20160905 OTC MONOGRAPH FINAL part333D Goodier Cosmetics LLC SALICYLIC ACID 2 g/100mL N 20181231 10481-0111_48e2e8d2-dbcc-46b8-8e30-15931d5240d7 10481-0111 HUMAN PRESCRIPTION DRUG LUGOLS SOLUTION LUGOLS LIQUID TOPICAL 20100201 UNAPPROVED DRUG OTHER Gordon Laboratories IODINE .4 g/g E 20171231 10481-0112_49a2555d-073f-4c02-8dc1-fdd42396cad4 10481-0112 HUMAN PRESCRIPTION DRUG MONSELS SOLUTION FERRIC SUBSULFATE LIQUID TOPICAL 20111207 UNAPPROVED DRUG OTHER Gordon Laboratories FERRIC SUBSULFATE .21 g/g E 20171231 10481-0112_4e54728c-f319-4f6a-8c99-dd9969a4ab41 10481-0112 HUMAN PRESCRIPTION DRUG MONSELS SOLUTION FERRIC SUBSULFATE LIQUID TOPICAL 20100209 UNAPPROVED DRUG OTHER Gordon Laboratories FERRIC SUBSULFATE .21 g/g E 20171231 10481-1050_01307296-8964-41c1-b39e-1f5b66649e43 10481-1050 HUMAN PRESCRIPTION DRUG Formadon Formaldehyde LIQUID TOPICAL 20100621 UNAPPROVED DRUG OTHER Gordon Laboratories FORMALDEHYDE .1 mL/59mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] E 20171231 10481-1050_cfef96d7-7c09-46f3-8b72-aefbd135d632 10481-1050 HUMAN PRESCRIPTION DRUG Formadon Formaldehyde LIQUID TOPICAL 20100621 UNAPPROVED DRUG OTHER Gordon Laboratories FORMALDEHYDE .1 mL/59mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] E 20171231 10481-1051_1c1a2895-4cac-0580-e054-00144ff8d46c 10481-1051 HUMAN PRESCRIPTION DRUG Silver Nitrate SILVER NITRATE LIQUID TOPICAL 20100714 UNAPPROVED DRUG OTHER Gordon Laboratories SILVER NITRATE .1 g/10g E 20171231 10481-1052_1c189c75-4928-14a8-e054-00144ff88e88 10481-1052 HUMAN PRESCRIPTION DRUG Silver Nitrate Silver Nitrate LIQUID TOPICAL 20100715 UNAPPROVED DRUG OTHER Gordon Laboratories SILVER NITRATE .025 g/g E 20171231 10481-1053_1bf3eb0c-d1dd-3e4d-e054-00144ff8d46c 10481-1053 HUMAN PRESCRIPTION DRUG Silver Nitrate Silver Nitrate LIQUID TOPICAL 20100714 UNAPPROVED DRUG OTHER Gordon Laboratories SILVER NITRATE .25 g/10g E 20171231 10481-3005_9d73475d-b995-402e-b64e-3811735604bb 10481-3005 HUMAN PRESCRIPTION DRUG GORDONS UREA 40 UREA OINTMENT TOPICAL 20100716 UNAPPROVED DRUG OTHER Gordon Laboratories UREA .4 g/g E 20171231 10481-3006_b92631c2-5e63-4526-acdc-a2940145407b 10481-3006 HUMAN PRESCRIPTION DRUG SODIUM HYDROXIDE SODIUM HYDROXIDE LIQUID TOPICAL 20100716 UNAPPROVED DRUG OTHER Gordon Laboratories SODIUM HYDROXIDE .01 g/g Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 10481-3008_0e395df5-9282-4c8f-8452-f3e9d8e1f315 10481-3008 HUMAN PRESCRIPTION DRUG TRI-CHLOR Trichloroacetic Acid LIQUID TOPICAL 20100712 UNAPPROVED DRUG OTHER Gordon Laboratories TRICHLOROACETIC ACID .8 g/g E 20171231 10481-3012_fdb68978-98c7-4814-abd3-df3d329a77d5 10481-3012 HUMAN PRESCRIPTION DRUG POTASSIUM HYDROXIDE POTASSIUM HYDROXIDE LIQUID TOPICAL 20100716 UNAPPROVED DRUG OTHER Gordon Laboratories POTASSIUM HYDROXIDE .05 g/g E 20171231 10481-3015_223583ec-b53c-4191-8efe-03b177a2b5c4 10481-3015 HUMAN PRESCRIPTION DRUG Forma-Ray FORMALDEHYDE LIQUID TOPICAL 20100715 UNAPPROVED DRUG OTHER Gordon Laboratories FORMALDEHYDE .2 mL/59mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] E 20171231 10481-3015_ae86e612-b396-4f7b-8832-cfa367876e9a 10481-3015 HUMAN PRESCRIPTION DRUG Forma-Ray Formaldehyde LIQUID TOPICAL 20100715 UNAPPROVED DRUG OTHER Gordon Laboratories FORMALDEHYDE .2 mL/59mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] E 20171231 10482-001_abdace73-1b5c-4b4c-9a78-0a702c59f34e 10482-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19750101 NDA NDA205865 R. N. Goss Gas Products Company OXYGEN 995 L/L N 20181231 10492-001_c6989392-6f17-4f3a-903d-a49cd02d6734 10492-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800101 NDA NDA205865 Greco Gas Inc OXYGEN 995 mL/L N 20181231 10511-3001_5a205a4a-456c-4bb6-9c9a-11d053effe4c 10511-3001 HUMAN PRESCRIPTION DRUG Cysview Hexaminolevulinate hydrochloride KIT 20101001 NDA NDA022555 Photocure ASA N 20181231 10515-140_d0a2f64e-e474-4dd0-be29-35fce160db72 10515-140 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080215 ANDA ANDA063140 GC Hanford Manufacturing Company AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 10515-142_f8f11211-7284-4ca9-85e2-6a069f89c5b8 10515-142 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080215 ANDA ANDA063142 GC Hanford Manufacturing Company AMPICILLIN SODIUM 10 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 10515-145_d0a2f64e-e474-4dd0-be29-35fce160db72 10515-145 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100917 ANDA ANDA063145 GC Hanford Manufacturing Company AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 10515-146_d0a2f64e-e474-4dd0-be29-35fce160db72 10515-146 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080215 ANDA ANDA063146 GC Hanford Manufacturing Company AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 10515-772_d0a2f64e-e474-4dd0-be29-35fce160db72 10515-772 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080215 ANDA ANDA062772 GC Hanford Manufacturing Company AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 10526-001_4eae141a-d361-4fc3-94cd-9ce6f5452e90 10526-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900101 NDA NDA205767 Haun Welding Supply, Inc. OXYGEN 990 L/L N 20181231 10526-003_db94d061-c5c7-4480-a907-6e23233e5616 10526-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen LIQUID RESPIRATORY (INHALATION) 19900101 NDA NDA205766 Haun Welding Supply, Inc. NITROGEN 990 L/L N 20181231 10530-128_8c7aa135-509f-4263-8897-fc80eff2c05a 10530-128 HUMAN OTC DRUG Nexco Cream 75 Echinacea angustifolia, Glycyrrhiza Glabra. CREAM TOPICAL 20160329 UNAPPROVED HOMEOPATHIC Nexco Pharma ECHINACEA ANGUSTIFOLIA; GLYCYRRHIZA GLABRA 3; 3 [hp_X]/mL; [hp_X]/mL N 20181231 10542-009_c4809618-5cdf-4840-8d23-78e110d43adc 10542-009 HUMAN PRESCRIPTION DRUG Dialyvite Supreme D Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium TABLET, COATED ORAL 20100908 UNAPPROVED DRUG OTHER Hillestad Pharmaceuticals USA ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; COBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; ZINC CITRATE; SELENOCYSTEINE 100; 2000; 30; 1.5; 1.7; 20; 25; 3; 1; 300; 10; 15; 70 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 10542-010_dfb4645a-c0b5-4470-9281-12179a8fac45 10542-010 HUMAN PRESCRIPTION DRUG Dialyvite Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid TABLET, COATED ORAL 19880801 UNAPPROVED DRUG OTHER Hillestad Pharmaceuticals USA ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; COBALAMIN; BIOTIN; CALCIUM PANTOTHENATE 100; 1.5; 1.7; 20; 10; 1; 6; 300; 10 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 10542-011_ab594f28-a30b-4af4-b117-66433562b2d5 10542-011 HUMAN PRESCRIPTION DRUG Dialyvite 5000 Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium TABLET, COATED ORAL 20080501 UNAPPROVED DRUG OTHER Hillestad Pharmaceuticals USA ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; COBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; ZINC CITRATE; .ALPHA.-TOCOPHEROL SUCCINATE, D-; SELENOCYSTEINE 100; 1.5; 1.7; 20; 50; 5; 2; 300; 10; 25; 30; 70 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 10542-012_b7086cae-4036-4108-a854-cb1427969d3d 10542-012 HUMAN PRESCRIPTION DRUG Dialyvite with Zinc Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc TABLET, COATED ORAL 20021001 UNAPPROVED DRUG OTHER Hillestad Pharmaceuticals USA ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; COBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; ZINC CITRATE 100; 1.5; 1.7; 20; 10; 1; 6; 300; 10; 50 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 10542-014_346217d9-9eff-4ff8-8e06-5cbc545881d0 10542-014 HUMAN PRESCRIPTION DRUG Dialyvite 3000 Ascorbic Acid, Tocopheryl Acid Succinate, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid, Zinc, Selenium TABLET, COATED ORAL 20040201 UNAPPROVED DRUG OTHER Hillestad Pharmaceuticals USA ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; COBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; ZINC CITRATE; .ALPHA.-TOCOPHEROL SUCCINATE, D-; SELENOCYSTEINE 100; 1.5; 1.7; 20; 25; 3; 1; 300; 10; 15; 30; 70 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 10544-001_11b99f8b-d06a-50c3-e054-00144ff88e88 10544-001 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20100520 ANDA ANDA040159 Blenheim Pharmacal, Inc. MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 10544-002_17b18994-0790-4262-8680-8167fd7f88fc 10544-002 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20100520 NDA NDA013217 Blenheim Pharmacal, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 10544-003_17114c5d-e704-0cbc-e054-00144ff88e88 10544-003 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20100611 ANDA ANDA078671 Blenheim Pharmacal, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-004_1109c5be-5749-398c-e054-00144ff8d46c 10544-004 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100611 ANDA ANDA065253 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-005_26de9cce-3b1f-4a5f-b2b7-0ac5584d793a 10544-005 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20100616 ANDA ANDA076636 Blenheim Pharmacal, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10544-006_d9785b1d-f224-42cc-9f46-402feb3f9b15 10544-006 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100706 ANDA ANDA077031 Blenheim Pharmacal, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-007_7b0ae531-214a-42ed-b55b-9ad6f7d3cc59 10544-007 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100720 20190228 ANDA ANDA065271 Blenheim Pharmacal, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 10544-009_39619a05-3d1b-454b-9356-3465c63735f6 10544-009 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100813 ANDA ANDA076003 Blenheim Pharmacal, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV E 20171231 10544-010_fdd1e667-81eb-4023-b70b-5037015f905b 10544-010 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100819 ANDA ANDA074201 Blenheim Pharmacal, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-011_c8544f93-feab-405c-ab46-61803b486e99 10544-011 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100820 ANDA ANDA090705 Blenheim Pharmacal, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 10544-013_443e66c6-a144-4910-a175-db140d15ac20 10544-013 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100908 ANDA ANDA065229 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-014_e4370315-e6c1-40b7-a529-33f79ff1d819 10544-014 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100908 ANDA ANDA078558 Blenheim Pharmacal, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-015_8576a1a3-c3c0-4a5e-8b8a-b55d1999fdd1 10544-015 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100915 ANDA ANDA078558 Blenheim Pharmacal, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-016_ba7d1b7d-2922-4f13-a0d6-df49e336d10e 10544-016 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100915 ANDA ANDA075927 Blenheim Pharmacal, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-017_11bb8608-b5bd-63e9-e054-00144ff8d46c 10544-017 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20100915 ANDA ANDA040804 Blenheim Pharmacal, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 10544-019_38f4b146-eddb-4c0f-8e9a-2200ba0b756d 10544-019 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100924 ANDA ANDA075927 Blenheim Pharmacal, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-020_9fc0b42f-ecb7-4070-a18c-e57d5a53778a 10544-020 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100928 ANDA ANDA062702 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 E 20171231 10544-021_82ccb8d4-ea91-428c-a1f2-9c7c5bc31cd9 10544-021 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101004 ANDA ANDA065229 Blenheim Pharmacal, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-024_8576a1a3-c3c0-4a5e-8b8a-b55d1999fdd1 10544-024 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20101103 ANDA ANDA078558 Blenheim Pharmacal, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-025_bb6ce0ee-0d20-43d0-b3b7-78518fec1cf3 10544-025 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101105 ANDA ANDA065152 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-028_c66d2f72-9a5d-43ac-a837-0cb66042f6b2 10544-028 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20101201 ANDA ANDA040702 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-029_c1221ecf-31fc-453d-8f6c-3a97db853a05 10544-029 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20101210 ANDA ANDA074342 Blenheim Pharmacal, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 10544-030_8576a1a3-c3c0-4a5e-8b8a-b55d1999fdd1 10544-030 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20101220 ANDA ANDA078558 Blenheim Pharmacal, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-031_c16f2d09-e719-4846-94a6-d38ccdb8c9b1 10544-031 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100107 ANDA ANDA076900 Blenheim Pharmacal, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-032_3f30a7c7-5db4-426a-b96e-966d03fec82a 10544-032 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110131 ANDA ANDA040419 Blenheim Pharmacal, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII E 20171231 10544-033_9ffdab20-bd56-47c8-813e-41c746538677 10544-033 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20110202 ANDA ANDA040245 Blenheim Pharmacal, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV E 20171231 10544-035_cbf00b1c-4767-4d3d-b590-6dfe7425d282 10544-035 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110215 ANDA ANDA078906 Blenheim Pharmacal, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 10544-036_9f0a21b7-570c-4c18-a512-071d9d67b74a 10544-036 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20110215 ANDA ANDA075593 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-039_f41aa20a-8824-477e-8f04-69760ba1197e 10544-039 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20110302 ANDA ANDA074980 Blenheim Pharmacal, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 10544-040_7a7c3ee5-d811-4f21-a783-fe5796097f0f 10544-040 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20110311 ANDA ANDA078426 Blenheim Pharmacal, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 10544-041_112cbc20-15ac-5ac1-e054-00144ff8d46c 10544-041 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20110315 ANDA ANDA091042 Blenheim Pharmacal, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII E 20171231 10544-042_112db91e-a6bb-42b6-e054-00144ff88e88 10544-042 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20110401 ANDA ANDA070976 Blenheim Pharmacal, Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 10544-043_11bb8608-b5bd-63e9-e054-00144ff8d46c 10544-043 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20110418 ANDA ANDA040804 Blenheim Pharmacal, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 10544-044_8eb3883b-e794-4d59-aa00-a870df172b97 10544-044 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110504 ANDA ANDA075927 Blenheim Pharmacal, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-045_112a16d0-4ac7-164d-e054-00144ff88e88 10544-045 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20110615 ANDA ANDA085161 Blenheim Pharmacal, Inc. PREDNISONE 20 mg/1 E 20171231 10544-046_112a16d0-4ac7-164d-e054-00144ff88e88 10544-046 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20110615 ANDA ANDA085162 Blenheim Pharmacal, Inc. PREDNISONE 10 mg/1 E 20171231 10544-047_d4424cb8-19eb-48b6-bfbd-08beb0e7c67b 10544-047 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110615 ANDA ANDA040807 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-048_11bd20df-7fd4-2a51-e054-00144ff8d46c 10544-048 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20110705 ANDA ANDA085162 Blenheim Pharmacal, Inc. PREDNISONE 10 mg/1 E 20171231 10544-049_11a7210e-67ae-67ac-e054-00144ff8d46c 10544-049 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20110705 ANDA ANDA073449 Blenheim Pharmacal, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-051_0f60819b-0015-42fb-e054-00144ff88e88 10544-051 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET ORAL 20110825 ANDA ANDA040712 Blenheim Pharmacal, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 10544-052_03382d4b-f5bf-4f32-bb6b-fdd8e348cd3b 10544-052 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20110902 ANDA ANDA077918 Blenheim Pharmacal, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-053_112f3db2-aa31-4559-e054-00144ff8d46c 10544-053 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110909 ANDA ANDA090624 Blenheim Pharmacal, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 10544-054_11bc4b3c-970f-0b24-e054-00144ff8d46c 10544-054 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20110914 ANDA ANDA074342 Blenheim Pharmacal, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 10544-055_112f6f15-abfa-07a7-e054-00144ff88e88 10544-055 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL 20110914 UNAPPROVED DRUG OTHER Blenheim Pharmacal, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 E 20171231 10544-056_11befb08-9e41-7500-e054-00144ff8d46c 10544-056 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20110930 ANDA ANDA077824 Blenheim Pharmacal, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 10544-057_11f3b578-7076-4b9c-e054-00144ff8d46c 10544-057 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20120627 ANDA ANDA062791 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-058_112e1e53-1ced-0f7e-e054-00144ff8d46c 10544-058 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20030417 ANDA ANDA075978 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-060_112f3db2-aab3-4559-e054-00144ff8d46c 10544-060 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20111115 ANDA ANDA062676 Blenheim Pharmacal, Inc. DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 10544-061_112fdec3-882c-14df-e054-00144ff88e88 10544-061 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120215 ANDA ANDA076494 Blenheim Pharmacal, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-062_11b99f8b-d06a-50c3-e054-00144ff88e88 10544-062 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20100520 ANDA ANDA040159 Blenheim Pharmacal, Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 10544-063_ef68a8ac-c8ad-47cd-88dc-1aa2c31601e8 10544-063 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20120112 ANDA ANDA078314 Blenheim Pharmacal, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-065_11813bd5-169f-0fa5-e054-00144ff88e88 10544-065 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20120118 ANDA ANDA078619 Blenheim Pharmacal, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-066_945a7bfa-11b3-4903-9875-365ecf31f184 10544-066 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120119 ANDA ANDA065215 Blenheim Pharmacal, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-067_11319112-6ec6-32e7-e054-00144ff8d46c 10544-067 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120213 ANDA ANDA075978 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-068_11319112-6ec6-32e7-e054-00144ff8d46c 10544-068 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120213 ANDA ANDA075978 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-069_1131085d-d458-1e3a-e054-00144ff8d46c 10544-069 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20120214 ANDA ANDA040114 Blenheim Pharmacal, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 10544-070_1131085d-d458-1e3a-e054-00144ff8d46c 10544-070 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20120305 ANDA ANDA040114 Blenheim Pharmacal, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 10544-071_0f7b92ea-a829-70a9-e054-00144ff8d46c 10544-071 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20120323 ANDA ANDA075682 Blenheim Pharmacal, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-072_1313f0dc-5975-5ec7-e054-00144ff8d46c 10544-072 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20120330 ANDA ANDA071611 Blenheim Pharmacal, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 10544-073_11319112-6eca-32e7-e054-00144ff8d46c 10544-073 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20120509 ANDA ANDA065095 Blenheim Pharmacal, Inc. DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 10544-075_11319112-6ee1-32e7-e054-00144ff8d46c 10544-075 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20120524 ANDA ANDA065435 Blenheim Pharmacal, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 10544-076_11322d75-10c5-6db4-e054-00144ff88e88 10544-076 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20120524 NDA NDA019129 Blenheim Pharmacal, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-077_112f6f15-abfa-07a7-e054-00144ff88e88 10544-077 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL 20120606 UNAPPROVED DRUG OTHER Blenheim Pharmacal, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 E 20171231 10544-079_fc393ceb-1bfa-4554-9f83-358af3853e94 10544-079 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20120627 ANDA ANDA076639 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-080_1167b13c-5b2c-2193-e054-00144ff88e88 10544-080 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 20120801 ANDA ANDA072011 Blenheim Pharmacal, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-081_1169212a-8191-5337-e054-00144ff88e88 10544-081 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20120801 ANDA ANDA040659 Blenheim Pharmacal, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 10544-082_134a8f8c-7fb1-4033-e054-00144ff88e88 10544-082 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120801 ANDA ANDA062713 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-083_106f49e0-fdf7-4596-a3d3-c3c0ce363b8f 10544-083 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20120813 ANDA ANDA091276 Blenheim Pharmacal, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-084_e702b20c-01e7-40b4-89eb-e8bd065844c0 10544-084 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120823 ANDA ANDA078329 Blenheim Pharmacal, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-085_b9265fa0-135e-487b-a5e0-537ec64890f9 10544-085 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20120904 ANDA ANDA076045 Blenheim Pharmacal, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 10544-086_1168f072-08bf-485c-e054-00144ff8d46c 10544-086 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20120906 NDA NDA020064 Blenheim Pharmacal, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 10544-087_1169212a-8193-5337-e054-00144ff88e88 10544-087 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20120914 ANDA ANDA087425 Blenheim Pharmacal, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] E 20171231 10544-088_116968c7-c19d-4858-e054-00144ff8d46c 10544-088 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20121015 ANDA ANDA040823 Blenheim Pharmacal, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 10544-089_f41aa20a-8824-477e-8f04-69760ba1197e 10544-089 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir CAPSULE ORAL 20121024 ANDA ANDA074975 Blenheim Pharmacal, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 10544-090_87c6d3e2-7c66-479b-abe8-551cb8913921 10544-090 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20121024 ANDA ANDA077918 Blenheim Pharmacal, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-091_11bc07bb-a79c-00f3-e054-00144ff8d46c 10544-091 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20121116 ANDA ANDA040804 Blenheim Pharmacal, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 10544-092_57ab565c-87af-4732-a757-09ae9f42cd7c 10544-092 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20121205 ANDA ANDA090828 Blenheim Pharmacal, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 10544-093_116acf2b-e611-0e90-e054-00144ff88e88 10544-093 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20121218 ANDA ANDA084122 Blenheim Pharmacal, Inc. PREDNISONE 10 mg/1 E 20171231 10544-094_11f47c1a-98c2-28eb-e054-00144ff88e88 10544-094 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20130114 ANDA ANDA040749 Blenheim Pharmacal, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 10544-095_1362b9a3-135e-7402-e054-00144ff8d46c 10544-095 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130114 ANDA ANDA062396 Blenheim Pharmacal, Inc. DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 10544-096_9d8e8cc9-6ddc-400f-aeed-b7e2db293f4d 10544-096 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20130116 ANDA ANDA062058 Blenheim Pharmacal, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 10544-098_134a89f6-cf71-3ffb-e054-00144ff88e88 10544-098 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20130311 ANDA ANDA087022 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 10544-099_1314a031-867b-718d-e054-00144ff88e88 10544-099 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20130318 ANDA ANDA040886 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 10544-100_21c498e0-47f1-4958-9126-86ddde5f2d78 10544-100 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine acetaminophen and codeine phosphate TABLET ORAL 20131111 ANDA ANDA089805 Blenheim Pharmacal, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 10544-101_dd572eaf-b4d5-4bc9-b9b9-a648dd36402e 10544-101 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20110215 ANDA ANDA074578 Blenheim Pharmacal, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 10544-102_1217cc75-15cd-4c1b-8147-125d7db61bd7 10544-102 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20100311 ANDA ANDA074556 Blenheim Pharmacal, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 10544-103_134b910d-0729-33ec-e054-00144ff8d46c 10544-103 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20100720 ANDA ANDA074556 Blenheim Pharmacal, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 10544-104_116b82c7-e1d2-222a-e054-00144ff8d46c 10544-104 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20091216 ANDA ANDA074112 Blenheim Pharmacal, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 10544-105_1364d959-1f7e-582c-e054-00144ff8d46c 10544-105 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130328 ANDA ANDA040412 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-106_c1221ecf-31fc-453d-8f6c-3a97db853a05 10544-106 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100413 ANDA ANDA074342 Blenheim Pharmacal, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 10544-107_c1221ecf-31fc-453d-8f6c-3a97db853a05 10544-107 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100423 ANDA ANDA074342 Blenheim Pharmacal, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 10544-108_e3fa8c4d-8fd6-4742-b8cc-5518f9b48cb2 10544-108 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 20091216 ANDA ANDA087128 Blenheim Pharmacal, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 10544-109_44ed0507-a6e1-48ac-bd34-2b5ced777e4b 10544-109 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100804 ANDA ANDA085966 Blenheim Pharmacal, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 10544-110_8f689b85-94ab-423e-94b6-de77fc212ea1 10544-110 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100303 ANDA ANDA085968 Blenheim Pharmacal, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 10544-111_cfb04bc4-c90a-4896-bd78-413854190d45 10544-111 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20130328 ANDA ANDA091416 Blenheim Pharmacal, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-112_fbeeafae-b466-42d3-8e1a-27a4626cc0c2 10544-112 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20120118 ANDA ANDA077955 Blenheim Pharmacal, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 10544-113_fbeeafae-b466-42d3-8e1a-27a4626cc0c2 10544-113 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20120118 ANDA ANDA077955 Blenheim Pharmacal, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 10544-114_17151304-01b8-1bed-e054-00144ff8d46c 10544-114 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20130328 ANDA ANDA074514 Blenheim Pharmacal, Inc DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-115_0f7c3734-dfa6-7082-e054-00144ff88e88 10544-115 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20100520 UNAPPROVED DRUG OTHER Blenheim Pharmacal, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 E 20171231 10544-116_cd3179bd-28a3-4fb0-ba34-d8c8ba3b7267 10544-116 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20091221 ANDA ANDA040876 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 10544-118_448fb15d-452a-47e2-bc3f-21ec85a6a5c6 10544-118 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20130522 ANDA ANDA074174 Blenheim Pharmacal, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 10544-120_b68c4f58-fe32-4d3b-998a-12e80a1d8432 10544-120 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20130522 ANDA ANDA091083 Blenheim Pharmacal, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-121_116d86ea-6a9e-00f3-e054-00144ff88e88 10544-121 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20130628 ANDA ANDA087425 Blenheim Pharmacal, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] E 20171231 10544-122_116d482a-f6e9-6130-e054-00144ff88e88 10544-122 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 20100330 ANDA ANDA062882 Blenheim Pharmacal, Inc. AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 10544-123_0ff56761-89ec-5239-e054-00144ff88e88 10544-123 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20130710 ANDA ANDA040749 Blenheim Pharmacal, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 10544-124_eb4b7a1e-97c5-4b21-af68-485735bebb69 10544-124 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20130710 ANDA ANDA074644 Blenheim Pharmacal, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-125_116acf2b-e611-0e90-e054-00144ff88e88 10544-125 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20130731 ANDA ANDA087342 Blenheim Pharmacal, Inc. PREDNISONE 20 mg/1 E 20171231 10544-126_c16f2d09-e719-4846-94a6-d38ccdb8c9b1 10544-126 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20120119 ANDA ANDA076900 Blenheim Pharmacal, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-127_101dd20f-f505-0837-e054-00144ff88e88 10544-127 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20101021 ANDA ANDA077877 Blenheim Pharmacal, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-128_117b20fa-6ccd-5852-e054-00144ff88e88 10544-128 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20130826 ANDA ANDA078432 Blenheim Pharmacal, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-129_0ff56761-89ec-5239-e054-00144ff88e88 10544-129 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20101101 ANDA ANDA040749 Blenheim Pharmacal, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 10544-130_117c74e5-7084-543d-e054-00144ff88e88 10544-130 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20130826 OTC MONOGRAPH NOT FINAL part334 Blenheim Pharmacal, Inc. DOCUSATE SODIUM 100 mg/1 E 20171231 10544-131_c47fbc0b-c7c7-4002-8e0e-bb5b25be363e 10544-131 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130830 ANDA ANDA078010 Blenheim Pharmacal, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 10544-132_117c82a6-2095-566b-e054-00144ff88e88 10544-132 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20110131 ANDA ANDA040124 Blenheim Pharmacal, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 10544-133_1d11c75b-0119-4e1c-9748-83feb2ebe3f2 10544-133 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20130830 ANDA ANDA090564 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-134_101dd20f-f505-0837-e054-00144ff88e88 10544-134 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130903 ANDA ANDA077877 Blenheim Pharmacal, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-135_11e2a86f-0d12-4eda-8472-9b94efe2ef58 10544-135 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20110711 ANDA ANDA065392 Blenheim Pharmacal, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-136_d4424cb8-19eb-48b6-bfbd-08beb0e7c67b 10544-136 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20131001 ANDA ANDA040807 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-142_1109c5be-5749-398c-e054-00144ff8d46c 10544-142 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100908 ANDA ANDA065253 Blenheim Pharmacal, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-143_2b486d6b-3dc3-4542-e054-00144ff88e88 10544-143 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20130905 ANDA ANDA200839 Blenheim Pharmacal, Inc. LEVOFLOXACIN 500 mg/1 E 20171231 10544-144_1ec86d05-f8ad-684f-e054-00144ff88e88 10544-144 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20130911 ANDA ANDA203399 Blenheim Pharmacal, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 10544-147_6d03f411-82a3-4198-b5b8-bd57793716db 10544-147 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20100203 ANDA ANDA076794 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-149_6f0602c1-3369-44c5-a3d3-140bc191d96d 10544-149 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100104 ANDA ANDA077048 Blenheim Pharmacal, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-150_134caaf3-2e01-5f42-e054-00144ff8d46c 10544-150 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100104 ANDA ANDA077048 Blenheim Pharmacal, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-153_deed27f1-99b9-4393-ae8b-3f1b7b6f31bf 10544-153 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20101101 ANDA ANDA065061 Blenheim Pharmacal, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 10544-154_117f2906-2c9a-3c0e-e054-00144ff88e88 10544-154 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20121102 ANDA ANDA063083 Blenheim Pharmacal, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 10544-155_11f616bd-5f65-554a-e054-00144ff88e88 10544-155 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20131115 ANDA ANDA074174 Blenheim Pharmacal, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 10544-158_065d29b4-d5c2-4ae2-bdb7-d32f1b1ea405 10544-158 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20100408 ANDA ANDA070924 Blenheim Pharmacal, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 10544-159_df94605b-0121-4285-8b97-7aa349c28d93 10544-159 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100125 ANDA ANDA078218 Blenheim Pharmacal, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 10544-161_7785e1b6-c121-4f46-a591-7ddd09a2aeda 10544-161 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20100413 ANDA ANDA077749 Blenheim Pharmacal, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 10544-165_ffabdb16-54db-4f3e-a818-4fc1162637a6 10544-165 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 20131115 ANDA ANDA064013 Blenheim Pharmacal, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 10544-166_11a88159-9fdc-1983-e054-00144ff8d46c 10544-166 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100512 OTC MONOGRAPH FINAL part341 Blenheim Pharmacal, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 10544-167_101ced94-a656-0123-e054-00144ff8d46c 10544-167 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20131115 ANDA ANDA077443 Blenheim Pharmacal, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-168_117ffce1-c52d-3684-e054-00144ff8d46c 10544-168 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100426 OTC MONOGRAPH NOT FINAL part334 Blenheim Pharmacal, Inc. DOCUSATE SODIUM 100 mg/1 E 20171231 10544-169_11f1bd08-cc5f-4b96-96ea-d97fc3102a39 10544-169 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20091222 ANDA ANDA062396 Blenheim Pharmacal, Inc. DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 10544-170_dd2b32b3-a1c6-49ea-8d7c-3407966584a1 10544-170 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20110418 ANDA ANDA075483 Blenheim Pharmacal, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 10544-171_101dd20f-f505-0837-e054-00144ff88e88 10544-171 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20131115 ANDA ANDA077877 Blenheim Pharmacal, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-172_134e5cb0-98bc-39e1-e054-00144ff88e88 10544-172 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20131115 ANDA ANDA077156 Blenheim Pharmacal, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 10544-173_7e310381-d7dd-410f-9064-31bcea2dcc87 10544-173 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20131115 ANDA ANDA079106 Blenheim Pharmacal, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-174_7e310381-d7dd-410f-9064-31bcea2dcc87 10544-174 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20131115 ANDA ANDA079106 Blenheim Pharmacal, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-175_9d16dfdc-91bb-49cb-b34b-fe37b0e7faea 10544-175 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 20131115 ANDA ANDA074532 Blenheim Pharmacal, Inc. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 10544-176_0f67e593-2c34-54d5-e054-00144ff88e88 10544-176 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20131115 ANDA ANDA074253 Blenheim Pharmacal, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 E 20171231 10544-178_118114cb-a199-63e8-e054-00144ff8d46c 10544-178 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20091209 ANDA ANDA076077 Blenheim Pharmacal, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 10544-179_1360de1e-16e6-131a-e054-00144ff8d46c 10544-179 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET, FILM COATED ORAL 20130930 ANDA ANDA077045 Blenheim Pharmacal, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-180_11813bd5-169f-0fa5-e054-00144ff88e88 10544-180 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20120118 ANDA ANDA078619 Blenheim Pharmacal, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-181_1f231e13-c279-45a0-8e5e-c6a21996b69a 10544-181 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20091222 ANDA ANDA076001 Blenheim Pharmacal, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-182_1360de1e-16e6-131a-e054-00144ff8d46c 10544-182 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET, FILM COATED ORAL 20110520 ANDA ANDA077045 Blenheim Pharmacal, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-184_1da0dc6d-1f09-4888-a04f-c6a8170e2b7b 10544-184 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20131115 ANDA ANDA078332 Blenheim Pharmacal, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 10544-185_1ec1a2d2-81a8-4b6d-ab02-62881d82facf 10544-185 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20101008 ANDA ANDA078787 Blenheim Pharmacal, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 10544-186_c3f02a0b-b418-438c-b25c-bfe17cda0848 10544-186 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100104 ANDA ANDA078428 Blenheim Pharmacal, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 10544-187_1da0dc6d-1f09-4888-a04f-c6a8170e2b7b 10544-187 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20131115 ANDA ANDA078332 Blenheim Pharmacal, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 10544-188_cc715a60-32e0-4d31-a1df-2a591a56d4e5 10544-188 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20131130 ANDA ANDA075185 Blenheim Pharmacal, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-189_df595412-7b9d-4fa2-a12d-e01f843abf4e 10544-189 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20130930 ANDA ANDA075185 Blenheim Pharmacal, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-190_1da0dc6d-1f09-4888-a04f-c6a8170e2b7b 10544-190 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20131115 ANDA ANDA078332 Blenheim Pharmacal, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 10544-191_1da0dc6d-1f09-4888-a04f-c6a8170e2b7b 10544-191 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20131115 ANDA ANDA078332 Blenheim Pharmacal, Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 10544-192_11f93c9c-792a-3add-e054-00144ff88e88 10544-192 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20100909 ANDA ANDA074223 Blenheim Pharmacal, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 10544-193_11f93c9c-792a-3add-e054-00144ff88e88 10544-193 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20120118 ANDA ANDA074223 Blenheim Pharmacal, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 10544-194_1181a59e-a434-20d0-e054-00144ff88e88 10544-194 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20131115 ANDA ANDA065434 Blenheim Pharmacal, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-195_1044ee11-1d9d-5435-e054-00144ff88e88 10544-195 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20131125 ANDA ANDA075657 Blenheim Pharmacal, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 10544-196_104fea5c-cb2d-16c3-e054-00144ff88e88 10544-196 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20131115 ANDA ANDA077901 Blenheim Pharmacal, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 10544-197_118f7c88-dd51-25d5-e054-00144ff88e88 10544-197 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20111220 NDA AUTHORIZED GENERIC NDA020504 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-198_118f7c88-dd6f-25d5-e054-00144ff88e88 10544-198 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100408 NDA AUTHORIZED GENERIC NDA020504 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-199_104fea5c-cb2d-16c3-e054-00144ff88e88 10544-199 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20131115 ANDA ANDA077901 Blenheim Pharmacal, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 10544-200_119094a0-1c9b-49cf-e054-00144ff88e88 10544-200 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20131115 ANDA ANDA078048 Blenheim Pharmacal, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 10544-201_37a7a356-bd9e-4dd8-98cc-bd3650a09105 10544-201 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20140204 ANDA ANDA090796 Blenheim Pharmacal, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-209_d360cdb2-78e7-45b3-a06a-6f19e2224a58 10544-209 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine TABLET, FILM COATED ORAL 20091228 ANDA ANDA088617 Blenheim Pharmacal, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 10544-210_52b17351-bfe0-406f-9569-990cc7f00422 10544-210 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine TABLET, FILM COATED ORAL 20100517 ANDA ANDA088618 Blenheim Pharmacal, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 10544-211_3e485ce7-a865-45b1-96c1-cdeed9ec40e0 10544-211 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 20131210 ANDA ANDA088237 Blenheim Pharmacal, Inc. DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 10544-212_3e485ce7-a865-45b1-96c1-cdeed9ec40e0 10544-212 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 20131115 ANDA ANDA088238 Blenheim Pharmacal, Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 10544-213_134f38e1-34f0-040e-e054-00144ff8d46c 10544-213 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100310 ANDA ANDA078558 Blenheim Pharmacal, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-214_1360d60f-2459-734a-e054-00144ff8d46c 10544-214 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100428 ANDA ANDA078558 Blenheim Pharmacal, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-216_119174f1-af30-355d-e054-00144ff8d46c 10544-216 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20101108 ANDA ANDA070624 Blenheim Pharmacal, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-217_10797255-7883-4f66-e054-00144ff8d46c 10544-217 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20131008 ANDA ANDA077091 Blenheim Pharmacal, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 10544-218_9a0bdb14-7e19-4e87-b4f1-70017d60e234 10544-218 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20100309 ANDA ANDA087425 Blenheim Pharmacal, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] E 20171231 10544-219_10797255-7883-4f66-e054-00144ff8d46c 10544-219 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20131008 ANDA ANDA077091 Blenheim Pharmacal, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 10544-220_119174f1-af66-355d-e054-00144ff8d46c 10544-220 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20130930 ANDA ANDA075795 Blenheim Pharmacal, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 10544-221_119174f1-af66-355d-e054-00144ff8d46c 10544-221 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20130930 ANDA ANDA075795 Blenheim Pharmacal, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 10544-222_17c86caa-1c3f-5c6c-e054-00144ff88e88 10544-222 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20110715 ANDA ANDA074754 Blenheim Pharmacal, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 10544-224_ec5c6a1e-a9e8-4b74-8175-960063bcd1a2 10544-224 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20131115 ANDA ANDA090939 Blenheim Pharmacal, Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-225_ec5c6a1e-a9e8-4b74-8175-960063bcd1a2 10544-225 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20131115 ANDA ANDA090939 Blenheim Pharmacal, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-226_31a005d8-7b61-4cac-bac5-78b0c09d46ca 10544-226 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20131118 ANDA ANDA040808 Blenheim Pharmacal, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 10544-227_31a005d8-7b61-4cac-bac5-78b0c09d46ca 10544-227 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20131118 ANDA ANDA040808 Blenheim Pharmacal, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 10544-228_1221a437-07b0-291f-e054-00144ff88e88 10544-228 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20101220 NDA NDA021210 Blenheim Pharmacal, Inc. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 10544-229_1221a437-07b0-291f-e054-00144ff88e88 10544-229 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20120213 NDA NDA021210 Blenheim Pharmacal, Inc. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 10544-230_ec5c6a1e-a9e8-4b74-8175-960063bcd1a2 10544-230 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20131115 ANDA ANDA090939 Blenheim Pharmacal, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-231_11926194-a657-2bfb-e054-00144ff88e88 10544-231 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20131113 ANDA ANDA076447 Blenheim Pharmacal, Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 E 20171231 10544-232_11925cb1-aa2a-2f64-e054-00144ff88e88 10544-232 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20131115 ANDA ANDA090937 Blenheim Pharmacal, Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 10544-234_1193ebb6-26bc-646c-e054-00144ff88e88 10544-234 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20131115 NDA NDA018858 Blenheim Pharmacal, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-235_0f88a46a-8488-3f5b-e054-00144ff88e88 10544-235 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20131009 ANDA ANDA075991 Blenheim Pharmacal, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 10544-236_468e33d9-bd82-4193-9270-c819f20b6b0f 10544-236 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20120430 ANDA ANDA077912 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 10544-237_468e33d9-bd82-4193-9270-c819f20b6b0f 10544-237 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20101220 ANDA ANDA077912 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 10544-238_52dfc887-7e11-4507-8182-2118284d2402 10544-238 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20091216 ANDA ANDA077321 Blenheim Pharmacal, Inc. LISINOPRIL 10 mg/1 E 20171231 10544-239_ba16b206-e57f-4593-997b-4856244c5400 10544-239 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20091216 ANDA ANDA077321 Blenheim Pharmacal, Inc. LISINOPRIL 20 mg/1 E 20171231 10544-240_9d64a851-28b2-4006-b2a9-4f523b565c59 10544-240 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20100520 ANDA ANDA077321 Blenheim Pharmacal, Inc. LISINOPRIL 40 mg/1 E 20171231 10544-241_0f88a46a-8488-3f5b-e054-00144ff88e88 10544-241 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20131009 ANDA ANDA075991 Blenheim Pharmacal, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 10544-242_0f88a46a-8488-3f5b-e054-00144ff88e88 10544-242 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20131009 ANDA ANDA075991 Blenheim Pharmacal, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 10544-243_364aab7b-d1f8-4cb1-ad8d-163dcf723c6e 10544-243 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20131115 ANDA ANDA200495 Blenheim Pharmacal, Inc. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 10544-244_119415c4-86cd-1626-e054-00144ff8d46c 10544-244 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110112 ANDA ANDA072927 Blenheim Pharmacal, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 10544-245_ecc5ff4e-9ce4-4778-9b92-c84f6b82b5b4 10544-245 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131115 ANDA ANDA076710 Blenheim Pharmacal, Inc. LEVOFLOXACIN 750 mg/1 E 20171231 10544-246_531d78b5-f3ba-4430-b6ad-85cabeb7d058 10544-246 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20100622 ANDA ANDA075828 Blenheim Pharmacal, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 10544-247_1221a437-07b0-291f-e054-00144ff88e88 10544-247 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20131115 NDA NDA021210 Blenheim Pharmacal, Inc. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 10544-248_101ced94-a6e4-0123-e054-00144ff8d46c 10544-248 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130930 ANDA ANDA076172 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-249_119415c4-86db-1626-e054-00144ff8d46c 10544-249 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20100611 OTC MONOGRAPH FINAL part336 Blenheim Pharmacal, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 E 20171231 10544-250_11f47c1a-992e-28eb-e054-00144ff88e88 10544-250 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20111005 ANDA ANDA085969 Blenheim Pharmacal, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 10544-251_ddfead24-bddd-4d4c-be92-1e6913ce5e0b 10544-251 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100423 ANDA ANDA077944 Blenheim Pharmacal, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-252_d89d204c-cb62-4b4f-9692-6243a1526f07 10544-252 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100413 ANDA ANDA077944 Blenheim Pharmacal, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-253_fefb4ed6-219a-4dd2-a6dc-59e767dba7d1 10544-253 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20110321 ANDA ANDA079148 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-254_20f8bc72-14ed-5e23-e054-00144ff8d46c 10544-254 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Blenheim Pharmacal Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-255_fefb4ed6-219a-4dd2-a6dc-59e767dba7d1 10544-255 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20100720 ANDA ANDA079148 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-256_1221646b-ea76-1ce9-e054-00144ff8d46c 10544-256 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20131115 NDA NDA021210 Blenheim Pharmacal, Inc. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 10544-257_1221646b-ea76-1ce9-e054-00144ff8d46c 10544-257 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20131118 NDA NDA021210 Blenheim Pharmacal, Inc. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 10544-258_1221a437-07b0-291f-e054-00144ff88e88 10544-258 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20131118 NDA NDA021210 Blenheim Pharmacal, Inc. LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 10544-259_21742a02-2fe3-2b9d-e054-00144ff88e88 10544-259 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Blenheim Pharmacal, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 10544-260_1221a437-07b0-291f-e054-00144ff88e88 10544-260 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20131118 NDA NDA021210 Blenheim Pharmacal, Inc. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 10544-261_1221a437-07b0-291f-e054-00144ff88e88 10544-261 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20131118 NDA NDA021210 Blenheim Pharmacal, Inc. LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 10544-262_1221a437-07b0-291f-e054-00144ff88e88 10544-262 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20131118 NDA NDA021210 Blenheim Pharmacal, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 10544-263_11960f64-9ad5-394f-e054-00144ff88e88 10544-263 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20101008 ANDA ANDA074141 Blenheim Pharmacal, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-264_1221a437-07b0-291f-e054-00144ff88e88 10544-264 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20131118 NDA NDA021210 Blenheim Pharmacal, Inc. LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 10544-265_2f319de6-79f0-454a-b9f8-9f9049ae898f 10544-265 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100414 ANDA ANDA070033 Blenheim Pharmacal, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 10544-266_1221a437-07b0-291f-e054-00144ff88e88 10544-266 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20131118 NDA NDA021210 Blenheim Pharmacal, Inc. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 10544-267_61b2fabf-ddef-4c5e-91f0-d6e78a96eb5a 10544-267 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20131118 NDA NDA021210 Blenheim Pharmacal, Inc. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 10544-269_4d903d0d-d3ba-43c1-a454-501d0c9e8846 10544-269 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20131118 ANDA ANDA078203 Blenheim Pharmacal, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 10544-270_0ff3b187-4774-1d14-e054-00144ff88e88 10544-270 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131220 ANDA ANDA070044 Blenheim Pharmacal, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 10544-271_17114c5d-e704-0cbc-e054-00144ff88e88 10544-271 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20131008 ANDA ANDA078671 Blenheim Pharmacal, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-273_c54513d2-ddbd-4ace-a48b-a4fd2d8f6bec 10544-273 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20100324 ANDA ANDA076009 Blenheim Pharmacal, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-274_0effd72e-4693-2bfa-e054-00144ff8d46c 10544-274 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20131115 ANDA ANDA040584 Blenheim Pharmacal, Inc. PREDNISONE 1 mg/1 E 20171231 10544-275_8f1f748d-b9e7-4b2c-a778-ee36ff4712d3 10544-275 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20100322 ANDA ANDA078314 Blenheim Pharmacal, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-276_8f1f748d-b9e7-4b2c-a778-ee36ff4712d3 10544-276 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20100317 ANDA ANDA078314 Blenheim Pharmacal, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-277_8f1f748d-b9e7-4b2c-a778-ee36ff4712d3 10544-277 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20091214 ANDA ANDA078250 Blenheim Pharmacal, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-278_8f1f748d-b9e7-4b2c-a778-ee36ff4712d3 10544-278 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100317 ANDA ANDA078250 Blenheim Pharmacal, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-280_0f553cbe-ba5f-283e-e054-00144ff88e88 10544-280 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20130930 ANDA ANDA078801 Blenheim Pharmacal, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 10544-281_0ff320ac-60f4-4b75-e054-00144ff88e88 10544-281 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 20131118 ANDA ANDA040268 Blenheim Pharmacal, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 10544-282_abd3ef23-cc2e-4cdd-a1fc-10faf361c414 10544-282 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20131118 ANDA ANDA078955 Blenheim Pharmacal, Inc. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-283_11a33d71-ca39-2da0-e054-00144ff8d46c 10544-283 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 20110810 ANDA ANDA040284 Blenheim Pharmacal, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 10544-284_abd3ef23-cc2e-4cdd-a1fc-10faf361c414 10544-284 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20131118 ANDA ANDA078955 Blenheim Pharmacal, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-285_abd3ef23-cc2e-4cdd-a1fc-10faf361c414 10544-285 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20131118 ANDA ANDA078955 Blenheim Pharmacal, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-286_1350786d-28a6-3b80-e054-00144ff8d46c 10544-286 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20131118 NDA AUTHORIZED GENERIC NDA018553 Blenheim Pharmacal, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-287_a2968165-848e-4000-9cad-c71e251a07bf 10544-287 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20091208 ANDA ANDA087463 Blenheim Pharmacal, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10544-288_0ff320ac-60e2-4b75-e054-00144ff88e88 10544-288 HUMAN PRESCRIPTION DRUG Sulfasalazine sulfasalazine TABLET ORAL 20131118 ANDA ANDA040349 Blenheim Pharmacal, Inc. SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 10544-289_0f547137-d43b-15f6-e054-00144ff8d46c 10544-289 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20131118 ANDA ANDA075498 Blenheim Pharmacal, Inc. TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 10544-292_2892f3c2-bff6-4411-adf3-fa065ac7c362 10544-292 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20131210 ANDA ANDA076161 Blenheim Pharmacal, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 10544-293_1044ee11-1d9d-5435-e054-00144ff88e88 10544-293 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20131210 ANDA ANDA075657 Blenheim Pharmacal, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 10544-295_11a46141-f467-0131-e054-00144ff88e88 10544-295 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20130930 ANDA ANDA075876 Blenheim Pharmacal, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 10544-296_10694145-3d30-1fbf-e054-00144ff8d46c 10544-296 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20100909 ANDA ANDA062936 Blenheim Pharmacal, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 10544-297_10694145-3d30-1fbf-e054-00144ff8d46c 10544-297 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20091229 ANDA ANDA062935 Blenheim Pharmacal, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 10544-298_11a4f560-2af2-187e-e054-00144ff8d46c 10544-298 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20131220 ANDA ANDA077739 Blenheim Pharmacal, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-299_11a46141-f467-0131-e054-00144ff88e88 10544-299 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20130930 ANDA ANDA075876 Blenheim Pharmacal, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 10544-300_11925cb1-aa2a-2f64-e054-00144ff88e88 10544-300 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20131001 ANDA ANDA090937 Blenheim Pharmacal, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 10544-430_37a7a356-bd9e-4dd8-98cc-bd3650a09105 10544-430 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20140204 ANDA ANDA090796 Blenheim Pharmacal, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-431_37a7a356-bd9e-4dd8-98cc-bd3650a09105 10544-431 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20140204 ANDA ANDA090796 Blenheim Pharmacal, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-432_31dc9892-0ea2-6511-e054-00144ff8d46c 10544-432 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-433_857595e2-e58f-4537-a629-7cc85cdc9897 10544-433 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20140206 ANDA ANDA075356 Blenheim Pharmacal, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-434_1ec9a16b-d696-1d4e-e054-00144ff88e88 10544-434 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20140207 ANDA ANDA065255 Blenheim Pharmacal, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 10544-436_a58e76e8-0645-4c40-a738-5015e88bd68c 10544-436 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140404 ANDA ANDA075360 Blenheim Pharmacal, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 10544-438_0fc48144-666e-0baf-e054-00144ff8d46c 10544-438 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20140225 ANDA ANDA078542 Blenheim Pharmacal, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 10544-439_2adeb324-8a46-15aa-e054-00144ff88e88 10544-439 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20140207 ANDA ANDA077662 Blenheim Pharmacal, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 10544-440_10673998-0ad1-3907-e054-00144ff8d46c 10544-440 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140219 ANDA ANDA077987 Blenheim Pharmacal, Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 10544-447_a58e76e8-0645-4c40-a738-5015e88bd68c 10544-447 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140404 ANDA ANDA075360 Blenheim Pharmacal, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 10544-448_2adeb324-8a46-15aa-e054-00144ff88e88 10544-448 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Blenheim Pharmacal, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 10544-451_0c78fe35-97dd-4d37-be95-27ed6c14e312 10544-451 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20150715 ANDA ANDA077652 Blenheim Pharmacal, Inc. LEVOFLOXACIN 500 mg/1 E 20171231 10544-455_0fc465dc-f0d9-06dc-e054-00144ff8d46c 10544-455 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20140209 ANDA ANDA076471 Blenheim Pharmacal, Inc. LORATADINE 10 mg/1 E 20171231 10544-464_23cd352d-9463-4cbe-e054-00144ff88e88 10544-464 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20140122 ANDA ANDA086988 Blenheim Pharmacal, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 10544-473_1b8eb062-6cc0-17fe-e054-00144ff88e88 10544-473 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140225 ANDA ANDA083677 Blenheim Pharmacal, Inc. PREDNISONE 20 mg/1 E 20171231 10544-481_1221646b-ea72-1ce9-e054-00144ff8d46c 10544-481 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20150325 ANDA ANDA075805 Blenheim Pharmacal, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 10544-486_46615c70-6322-4bcb-a8bb-c76e79f8bcff 10544-486 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20140210 ANDA ANDA077837 Blenheim Pharmacal, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 10544-487_46615c70-6322-4bcb-a8bb-c76e79f8bcff 10544-487 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20150227 ANDA ANDA077837 Blenheim Pharmacal, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 10544-489_e2a38cca-ce0e-4344-9fa1-11279c9f1aea 10544-489 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20131008 ANDA ANDA077627 Blenheim Pharmacal, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 10544-499_10538860-d9ae-6cfd-e054-00144ff8d46c 10544-499 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20140212 ANDA ANDA091426 Blenheim Pharmacal, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 10544-500_11a55a01-8ba4-21e5-e054-00144ff8d46c 10544-500 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20100908 ANDA ANDA060711 Blenheim Pharmacal, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 10544-503_7d7a65bd-ef86-4b09-94c2-a26c1aa2b227 10544-503 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20091222 ANDA ANDA065248 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-505_10673998-0ad1-3907-e054-00144ff8d46c 10544-505 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20120213 ANDA ANDA077987 Blenheim Pharmacal, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 10544-507_10673998-0ad1-3907-e054-00144ff8d46c 10544-507 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20120213 ANDA ANDA077987 Blenheim Pharmacal, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 10544-508_e14b112a-d01a-4d96-ae6a-7c6466245809 10544-508 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20091216 ANDA ANDA088832 Blenheim Pharmacal, Inc. PREDNISONE 10 mg/1 E 20171231 10544-509_e14b112a-d01a-4d96-ae6a-7c6466245809 10544-509 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20100317 ANDA ANDA083677 Blenheim Pharmacal, Inc. PREDNISONE 20 mg/1 E 20171231 10544-511_0ff320ac-60f4-4b75-e054-00144ff88e88 10544-511 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 20110401 ANDA ANDA040268 Blenheim Pharmacal, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 10544-512_cbbdb28c-bca7-4fc8-827b-1af408e34c05 10544-512 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20100330 ANDA ANDA040596 Blenheim Pharmacal, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 10544-516_11f47301-cec6-1516-e054-00144ff88e88 10544-516 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20101021 ANDA ANDA077824 Blenheim Pharmacal, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 10544-518_9afc1b0f-641b-4d14-9354-4d54f00bda9d 10544-518 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 20131002 ANDA ANDA075079 Blenheim Pharmacal, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 10544-521_101ced94-a6e4-0123-e054-00144ff8d46c 10544-521 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20131217 ANDA ANDA076869 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-522_f6a47a9e-897d-4982-9ee5-fd39f07e3922 10544-522 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20121005 ANDA ANDA065266 Blenheim Pharmacal, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 10544-523_0efe0854-7a72-10cd-e054-00144ff88e88 10544-523 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20131002 ANDA ANDA091426 Blenheim Pharmacal, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 10544-524_11a55d5f-72ba-0b65-e054-00144ff88e88 10544-524 HUMAN PRESCRIPTION DRUG SKELAXIN metaxalone TABLET ORAL 20100315 NDA NDA013217 Blenheim Pharmacal, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 10544-525_18932962-88a2-63d3-e054-00144ff88e88 10544-525 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20091216 ANDA ANDA076899 Blenheim Pharmacal, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 10544-527_0fefb3a2-f0c7-0544-e054-00144ff8d46c 10544-527 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20131002 ANDA ANDA040833 Blenheim Pharmacal, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] E 20171231 10544-528_0fecc82b-5d8d-1a19-e054-00144ff8d46c 10544-528 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20131002 ANDA ANDA076368 Blenhiem Pharmacal, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 10544-529_23e69fbd-7086-509e-e054-00144ff88e88 10544-529 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20131003 ANDA ANDA090836 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-531_e273cf85-8544-4ea3-8019-057611a85f55 10544-531 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100407 ANDA ANDA076003 Blenheim Pharmacal, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV E 20171231 10544-532_28d39d55-0689-4193-b87d-713272e01d2c 10544-532 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20120118 ANDA ANDA071524 Blenheim Pharmacal, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 10544-533_004ddf52-9e87-44a4-97e2-3c3293f7cf8c 10544-533 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20100303 ANDA ANDA071525 Blenheim Pharmacal, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 10544-534_83166335-99a1-4df0-9c95-5f31e9979a36 10544-534 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110401 ANDA ANDA071523 Blenheim Pharmacal, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 10544-535_11a60f9d-e508-424c-e054-00144ff8d46c 10544-535 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20131003 ANDA ANDA078596 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-536_1167b13c-5b2c-2193-e054-00144ff88e88 10544-536 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 20100408 ANDA ANDA073281 Blenheim Pharmacal, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-537_11a7210e-67ae-67ac-e054-00144ff8d46c 10544-537 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20100607 ANDA ANDA071851 Blenheim Pharmacal, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-538_1b8eb062-6cc0-17fe-e054-00144ff88e88 10544-538 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20131003 ANDA ANDA088832 Blenheim Pharmacal, Inc. PREDNISONE 10 mg/1 E 20171231 10544-539_11a76fc1-5a20-0509-e054-00144ff88e88 10544-539 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20131003 ANDA ANDA078616 Blenheim Pharmacal, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 10544-540_11a76fc1-5a20-0509-e054-00144ff88e88 10544-540 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20131003 ANDA ANDA078616 Blenheim Pharmacal, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 10544-541_3035088e-c702-4fbc-a024-16121a2f9b8a 10544-541 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100820 ANDA ANDA073568 Blenheim Pharmacal, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 10544-543_915057b6-5cd2-4b42-a897-e14aad53561e 10544-543 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20131004 ANDA ANDA078216 Blenheim Pharmacal, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-544_d19b12e4-5227-4b67-99a7-2a255d0fdf53 10544-544 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20131007 ANDA ANDA079237 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-545_810ae025-4953-474a-99a6-a0af36f1fe90 10544-545 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20131007 ANDA ANDA090637 Blenheim Pharmacal, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 10544-547_810ae025-4953-474a-99a6-a0af36f1fe90 10544-547 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20131007 ANDA ANDA090637 Blenheim Pharmacal, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 10544-548_11a91b50-63b6-457b-e054-00144ff88e88 10544-548 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20110107 ANDA ANDA078616 Blenheim Pharmacal, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 10544-549_2f1cd314-1433-43a7-be55-816675849d2f 10544-549 HUMAN PRESCRIPTION DRUG PRENATAL PLUS VITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, TABLET, FILM COATED ORAL 20101209 UNAPPROVED DRUG OTHER Blenheim Pharmacal, Inc. VITAMIN A ACETATE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE 3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 10544-550_84e4e4aa-fd78-42af-b677-c0d921033059 10544-550 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20131007 ANDA ANDA078938 Blenheim Pharmacal, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 10544-552_bb5ec995-bb58-47d2-a9f3-5cc29abe5d1a 10544-552 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20131021 ANDA ANDA040526 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 10544-553_eb4b7a1e-97c5-4b21-af68-485735bebb69 10544-553 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20131021 ANDA ANDA074644 Blenheim Pharmacal, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-554_0f553cbe-ba72-283e-e054-00144ff88e88 10544-554 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20131108 ANDA ANDA076820 Blenheim Pharmacal, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 10544-555_0c070fe3-2804-4f2d-8763-2458f0612604 10544-555 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20131108 ANDA ANDA077927 Blenheim Pharmacal, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-556_11aab8b5-dcc9-0d4a-e054-00144ff88e88 10544-556 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20131111 ANDA ANDA040156 Blenheim Pharmacal, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 10544-557_274b8f9f-9208-440f-bc63-34a52022f874 10544-557 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Blenheim Pharmacal, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 10544-558_ecc5ff4e-9ce4-4778-9b92-c84f6b82b5b4 10544-558 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131113 ANDA ANDA076710 Blenheim Pharmacal, Inc. LEVOFLOXACIN 500 mg/1 E 20171231 10544-559_0fed0008-656a-3728-e054-00144ff88e88 10544-559 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20131113 ANDA ANDA071655 Blenheim Pharmacal, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 10544-560_0fecc9b6-076c-148b-e054-00144ff88e88 10544-560 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20131113 ANDA ANDA040230 Blenheim Pharmacal, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 10544-561_4d8f36dc-b1c3-42dc-aae7-bc8c18db7073 10544-561 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20131113 ANDA ANDA076118 Blenheim Pharmacal, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 10544-562_0ff3b187-4774-1d14-e054-00144ff88e88 10544-562 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131113 ANDA ANDA070035 Blenheim Pharmacal, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 10544-563_7e310381-d7dd-410f-9064-31bcea2dcc87 10544-563 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20131115 ANDA ANDA079106 Blenheim Pharmacal, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-564_c5ca3b2d-1d53-4be1-899c-49b398cdacb3 10544-564 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20100504 ANDA ANDA077912 Blenheim Pharmacal, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-565_c4c5fe65-b476-482a-8e53-36f7be4748dc 10544-565 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131113 NDA AUTHORIZED GENERIC NDA018279 Blenheim Pharmacal, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 10544-566_0f553cbe-ba72-283e-e054-00144ff88e88 10544-566 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20131114 ANDA ANDA076820 Blenheim Pharmacal, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 10544-567_11b89d5f-c5c7-37b8-e054-00144ff88e88 10544-567 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20131114 ANDA ANDA073553 Blenheim Pharmacal, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 10544-569_0fda7dc5-ae1f-6ba0-e054-00144ff88e88 10544-569 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20131217 ANDA ANDA074270 Blenheim Pharmacal, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 10544-570_0fcd8102-2377-2adf-e054-00144ff88e88 10544-570 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 20131217 ANDA ANDA070994 Blenheim Pharmacal, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 10544-571_0f7c3734-dfa6-7082-e054-00144ff88e88 10544-571 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20100512 UNAPPROVED DRUG OTHER Blenheim Pharmacal, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 E 20171231 10544-575_0fd95943-e484-3fea-e054-00144ff88e88 10544-575 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20131217 ANDA ANDA078539 Blenheim Pharmacal, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 10544-576_9eb17a92-feec-42ce-b7ca-86367e164cc8 10544-576 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20140122 ANDA ANDA076533 Blenheim Pharmacal, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 10544-578_0fd8c46a-b0cd-52b3-e054-00144ff8d46c 10544-578 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20131220 ANDA ANDA040766 Blenheim Pharmacal, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] E 20171231 10544-579_0f5e4bb2-193d-3a95-e054-00144ff8d46c 10544-579 HUMAN PRESCRIPTION DRUG Glyburide-Metformin Hydrochloride Glyburide-Metformin Hydrochloride TABLET ORAL 20131220 ANDA ANDA079009 Blenheim Pharmacal, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-580_0f5e4bb2-193d-3a95-e054-00144ff8d46c 10544-580 HUMAN PRESCRIPTION DRUG Glyburide-Metformin Hydrochloride Glyburide-Metformin Hydrochloride TABLET ORAL 20131220 ANDA ANDA079009 Blenheim Pharmacal, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-582_1f231e13-c279-45a0-8e5e-c6a21996b69a 10544-582 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20091222 ANDA ANDA076001 Blenheim Pharmacal, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-583_11813bd5-169f-0fa5-e054-00144ff88e88 10544-583 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20120118 ANDA ANDA078619 Blenheim Pharmacal, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-584_c47fbc0b-c7c7-4002-8e0e-bb5b25be363e 10544-584 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20131220 ANDA ANDA078010 Blenheim Pharmacal, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 10544-585_10ddc30d-bacc-1c74-e054-00144ff8d46c 10544-585 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140228 ANDA ANDA075743 Blenheim Pharmacal, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 10544-586_101ced94-a656-0123-e054-00144ff8d46c 10544-586 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20140106 ANDA ANDA077443 Blenheim Pharmacal, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-587_1466fd7c-7f9c-548b-e054-00144ff8d46c 10544-587 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20140113 ANDA ANDA076533 Blenheim Pharmacal, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 10544-588_0fd762c0-ff4d-1f25-e054-00144ff8d46c 10544-588 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140113 ANDA ANDA091604 Blenheim Pharmacal, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 10544-589_20f8bc72-14ed-5e23-e054-00144ff8d46c 10544-589 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Blenheim Pharmacal Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-590_d10c81e5-ccfe-4977-9cb9-c7edcdda6dc8 10544-590 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100303 ANDA ANDA060704 Blenheim Pharmacal, Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 10544-592_cd3179bd-28a3-4fb0-ba34-d8c8ba3b7267 10544-592 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20100304 ANDA ANDA040887 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 10544-593_4035c0a2-7dc1-4bc3-9446-e05614d0c38b 10544-593 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20100304 ANDA ANDA087022 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 10544-594_3106c828-9c18-4530-89ae-b1c99ab6aa22 10544-594 HUMAN PRESCRIPTION DRUG Erythrocin Stearate Erythromycin Stearate TABLET, FILM COATED ORAL 20100309 ANDA ANDA060359 Blenheim Pharmacal, Inc. ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 10544-595_3106c828-9c18-4530-89ae-b1c99ab6aa22 10544-595 HUMAN PRESCRIPTION DRUG Erythrocin Stearate Erythromycin Stearate TABLET, FILM COATED ORAL 20100914 ANDA ANDA060359 Blenheim Pharmacal, Inc. ERYTHROMYCIN STEARATE 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 10544-597_fbeea6f8-f60a-494c-8bdf-093e48be509e 10544-597 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 20110401 ANDA ANDA040161 Blenheim Pharmacal, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 10544-598_12317209-2043-63dc-e054-00144ff8d46c 10544-598 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 20100330 ANDA ANDA011722 Blenheim Pharmacal, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 10544-599_4bae713c-47eb-4cdd-b727-3b4ec81825ae 10544-599 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20100406 ANDA ANDA076758 Blenheim Pharmacal, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10544-600_4bae713c-47eb-4cdd-b727-3b4ec81825ae 10544-600 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20100406 ANDA ANDA076758 Blenheim Pharmacal, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10544-601_2027c67a-6460-4013-bc09-0b2fe84ba35a 10544-601 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20100423 ANDA ANDA073652 Blenheim Pharmacal, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 10544-602_adbf74c6-22f0-4951-aa7f-80c3677705ca 10544-602 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20091230 ANDA ANDA040527 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 10544-603_a36b1389-0b15-4b35-a934-9702069d5314 10544-603 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET ORAL 20100517 ANDA ANDA076639 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-604_2d70eace-cfbd-433f-a0cc-4c39f4c1d926 10544-604 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN Ciprofloxacin TABLET, FILM COATED ORAL 20100517 ANDA ANDA075593 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-605_2d12d7b7-73ae-41b9-9a03-cecc9f4a5e97 10544-605 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20100517 ANDA ANDA075817 Blenheim Pharmacal, Inc. CIPROFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-606_025bb816-e2c4-416d-bba4-fb833f8496d5 10544-606 HUMAN PRESCRIPTION DRUG Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride TABLET ORAL 20100517 ANDA ANDA076089 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-607_c496b063-27b8-4675-aafc-6b65dd5aee3e 10544-607 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN Ciprofloxacin TABLET, FILM COATED ORAL 20100517 ANDA ANDA075593 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-608_912163f2-9b33-46ff-8357-a6bd69eedd75 10544-608 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET ORAL 20100517 ANDA ANDA076639 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-609_ed4145ff-111d-4248-a490-3bed1c24005c 10544-609 HUMAN PRESCRIPTION DRUG PRENATAL PLUS IRON MULTIVITAMIN/MULTIMINERAL SUPPLEMENT TABLET, FILM COATED ORAL 20100517 UNAPPROVED DRUG OTHER Blenheim Pharmacal, Inc. VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; IRON PENTACARBONYL; ZINC OXIDE; CUPRIC OXIDE 3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 29; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 10544-610_c65bc1a8-0487-4442-ac14-2efbac887d15 10544-610 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20100517 ANDA ANDA077253 Blenheim Pharmacal, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 10544-613_10457e1d-06ae-7071-e054-00144ff8d46c 10544-613 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100517 ANDA ANDA078558 Blenheim Pharmacal, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-614_11b938f8-f1df-4d63-e054-00144ff88e88 10544-614 HUMAN PRESCRIPTION DRUG NAPROXEN naproxen sodium TABLET, FILM COATED ORAL 20100517 ANDA ANDA074480 Blenheim Pharmacal, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-617_0d70804f-e1b8-4acf-8a65-fcadbd1f87b4 10544-617 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100517 ANDA ANDA065215 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 E 20171231 10544-618_18417b93-cfe9-4f53-86ab-afc912d0d06b 10544-618 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20100517 ANDA ANDA083426 Blenheim Pharmacal, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 10544-619_aeab7666-d9ce-47bd-92b2-b71112076fb2 10544-619 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100517 ANDA ANDA065291 Blenheim Pharmacal, Inc. AMOXICILLIN 500 mg/1 E 20171231 10544-620_1314a031-867b-718d-e054-00144ff88e88 10544-620 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20100517 ANDA ANDA040875 Blenheim Pharmacal, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 10544-621_b93cc1aa-1a9a-4e1a-9f2e-a02bf14c4ff1 10544-621 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20100517 ANDA ANDA040777 Blenheim Pharmacal, Inc. OXYCODONE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 10544-622_0fcdba6b-b72f-32cc-e054-00144ff88e88 10544-622 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20140113 ANDA ANDA090200 Blenheim Pharmacal, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 10544-623_10ddc30d-bacc-1c74-e054-00144ff8d46c 10544-623 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140114 ANDA ANDA075743 Blenheim Pharmacal, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 10544-624_b5c98fac-012c-4b12-a9c4-c1f1062887dc 10544-624 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20140114 ANDA ANDA201043 Blenheim Pharmacal, Inc. LEVOFLOXACIN 500 mg/1 E 20171231 10544-625_0f7b92ea-a829-70a9-e054-00144ff8d46c 10544-625 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20140114 ANDA ANDA075682 Blenheim Pharmacal, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-626_105668c7-5439-63fc-e054-00144ff8d46c 10544-626 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20140114 ANDA ANDA074151 Blenheim Pharmacal, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 10544-627_105668c7-5439-63fc-e054-00144ff8d46c 10544-627 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20140114 ANDA ANDA074151 Blenheim Pharmacal, Inc. CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 10544-628_98f178c8-7659-4b64-afcd-755a7387addd 10544-628 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20140122 ANDA ANDA079162 Blenheim Pharmacal, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 10544-629_2892f3c2-bff6-4411-adf3-fa065ac7c362 10544-629 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20131210 ANDA ANDA076161 Blenheim Pharmacal, Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 10544-630_f619faa6-4128-4bd9-a7f1-dace0d1f2f04 10544-630 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20140130 ANDA ANDA203769 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-631_0c070fe3-2804-4f2d-8763-2458f0612604 10544-631 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20140219 ANDA ANDA077927 Blenheim Pharmacal, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-632_0f7c3734-e05c-7082-e054-00144ff88e88 10544-632 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20140220 ANDA ANDA075657 Blenheim Pharmacal, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 10544-633_0f7c3734-e05c-7082-e054-00144ff88e88 10544-633 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20140220 ANDA ANDA075657 Blenheim Pharmacal, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 10544-653_13f0f08b-8311-2949-e054-00144ff88e88 10544-653 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20070919 ANDA ANDA077538 Blenheim Pharmacal, Inc. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 10544-670_14b4967f-6f33-4ade-e054-00144ff88e88 10544-670 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Blenheim Pharmacal, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 10544-673_31dc9892-0ea2-6511-e054-00144ff8d46c 10544-673 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-773_23cd352d-9463-4cbe-e054-00144ff88e88 10544-773 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20140122 ANDA ANDA086989 Blenheim Pharmacal, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 10544-809_857595e2-e58f-4537-a629-7cc85cdc9897 10544-809 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20140206 ANDA ANDA075356 Blenheim Pharmacal, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-847_e2a38cca-ce0e-4344-9fa1-11279c9f1aea 10544-847 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20131008 ANDA ANDA077627 Blenheim Pharmacal, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 10544-855_1467b4ed-05ef-6147-e054-00144ff8d46c 10544-855 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20150422 ANDA ANDA077253 Blenheim Pharmacal, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 10544-862_7382e434-9524-4a1d-b70f-86df3421daf6 10544-862 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20131008 ANDA ANDA075074 Blenheim Pharmacal, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-863_1fe204a5-8ca9-1fa1-e054-00144ff8d46c 10544-863 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20140408 ANDA ANDA076533 Blenheim Pharmacal, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 10544-867_0f7d09d5-3e32-07a7-e054-00144ff8d46c 10544-867 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20140522 ANDA ANDA071196 Blenheim Pharmacal, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 10544-868_34878bc2-1a24-4a65-b613-50a73930da66 10544-868 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140818 ANDA ANDA062713 Blenheim Pharmacal, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-874_6484b054-ceef-4b5c-a600-8df1646e65ac 10544-874 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20150420 ANDA ANDA090548 Blenheim Pharmacal, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 10544-878_135ea587-5c79-0ec7-e054-00144ff8d46c 10544-878 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141015 ANDA ANDA076048 Blenheim Pharmacal, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 10544-879_1eb06538-0a13-0db4-e054-00144ff88e88 10544-879 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 Blenheim Pharmacal, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 10544-883_1622f31d-3a6a-2887-e054-00144ff8d46c 10544-883 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC 20150515 ANDA ANDA064096 Blenheim Pharmacal, Inc. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 10544-884_0f5670ff-3e71-01b4-e054-00144ff8d46c 10544-884 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20141024 ANDA ANDA076558 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-890_0edb4ada-614a-2f85-e054-00144ff8d46c 10544-890 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20141218 ANDA ANDA076286 Blenheim Pharmacal, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 10544-895_135ea587-5c79-0ec7-e054-00144ff8d46c 10544-895 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150225 ANDA ANDA076048 Blenheim Pharmacal, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 10544-898_11a91ce7-8c58-4264-e054-00144ff88e88 10544-898 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150310 ANDA ANDA076048 Blenheim Pharmacal, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 10544-900_47a26958-3156-473b-952c-7a6eb8420cb9 10544-900 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20150406 ANDA ANDA040907 Blenheim Pharmacal, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 10544-901_17bc2c66-4093-4893-8623-c12f837028bf 10544-901 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20150327 ANDA ANDA077064 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-903_132542d2-a736-2043-e054-00144ff88e88 10544-903 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150219 ANDA ANDA075994 Blenheim Pharmacal, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 10544-904_132542d2-a736-2043-e054-00144ff88e88 10544-904 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150219 ANDA ANDA075994 Blenheim Pharmacal, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 10544-905_132542d2-a736-2043-e054-00144ff88e88 10544-905 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150219 ANDA ANDA075994 Blenheim Pharmacal, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 10544-906_2b486d6b-3dc3-4542-e054-00144ff88e88 10544-906 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150326 ANDA ANDA200839 Blenheim Pharmacal, Inc. LEVOFLOXACIN 750 mg/1 E 20171231 10544-907_2421553d-ef12-4bab-95ba-30c7924a652a 10544-907 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20150326 ANDA ANDA078155 Blenheim Pharmacal, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 10544-908_2421553d-ef12-4bab-95ba-30c7924a652a 10544-908 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20150326 ANDA ANDA078155 Blenheim Pharmacal, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 10544-909_13eef6e5-4535-3009-e054-00144ff8d46c 10544-909 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20150319 ANDA ANDA091211 Blenheim Pharmacal, Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] E 20171231 10544-911_147e8c8b-4884-1e43-e054-00144ff8d46c 10544-911 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20150421 ANDA ANDA071587 Blenheim Pharmacal, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 10544-912_169e4bef-3d2b-3be7-e054-00144ff88e88 10544-912 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 20150521 ANDA ANDA064053 Blenheim Pharmacal, Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 10544-913_74343126-7c09-4265-a3be-e67636278cb0 10544-913 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20150518 ANDA ANDA040362 Blenheim Pharmacal, Inc. PREDNISONE 5 mg/1 E 20171231 10544-914_74343126-7c09-4265-a3be-e67636278cb0 10544-914 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20150518 ANDA ANDA040362 Blenheim Pharmacal, Inc. PREDNISONE 10 mg/1 E 20171231 10544-915_74343126-7c09-4265-a3be-e67636278cb0 10544-915 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20150520 ANDA ANDA040362 Blenheim Pharmacal, Inc. PREDNISONE 20 mg/1 E 20171231 10544-917_17125c3e-c283-274c-e054-00144ff88e88 10544-917 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150519 NDA AUTHORIZED GENERIC NDA020998 Blenheim Pharmacal, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-918_17395669-5982-4536-e054-00144ff8d46c 10544-918 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150527 NDA AUTHORIZED GENERIC NDA020998 Blenheim Pharmcal, Inc CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-919_17c9214f-0ebb-0088-e054-00144ff88e88 10544-919 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20150601 ANDA ANDA091549 Blenheim Pharmacal, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-920_17c8f200-7f6f-6e6b-e054-00144ff88e88 10544-920 HUMAN PRESCRIPTION DRUG Naproxen delayed release Naproxen TABLET ORAL 20150604 ANDA ANDA091432 Blenheim Pharmacal, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-921_17151304-01b8-1bed-e054-00144ff8d46c 10544-921 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20150527 ANDA ANDA074514 Blenheim Pharmacal, Inc DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-922_171430d5-15dc-0511-e054-00144ff8d46c 10544-922 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20150527 ANDA ANDA075927 Blenheim Pharmacal,Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-923_7d011916-630b-4edc-9173-a70e6ad6d808 10544-923 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20150518 ANDA ANDA074514 Blenheim Pharmacal, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-924_17c83898-37aa-4cf9-e054-00144ff88e88 10544-924 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20150603 ANDA ANDA090796 Blenheim Pharmacal, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-925_d8d3e316-d33e-46e7-a7ae-02a86c39f2f9 10544-925 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Blenheim Pharmacal, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-926_17c7ace2-6f07-4111-e054-00144ff88e88 10544-926 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20150602 ANDA ANDA076817 Blenheim Pharmacal, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 10544-928_219d225c-a0fb-748a-e054-00144ff88e88 10544-928 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150602 ANDA ANDA076201 Blenheim Pharmacal, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-929_1b53f099-4eaf-2ee2-e054-00144ff88e88 10544-929 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150720 NDA AUTHORIZED GENERIC NDA020998 Blenheim Pharmacal, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-931_31a4aaf9-1795-02e7-e054-00144ff88e88 10544-931 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20150528 ANDA ANDA091568 Blenheim Pharmacal, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 10544-933_1ed81758-3e5f-46d2-e054-00144ff88e88 10544-933 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Blenheim Pharmacal, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-934_1ea0a3ac-88ac-48c1-e054-00144ff8d46c 10544-934 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20150715 ANDA ANDA090066 Blenheim Pharmacal, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-935_fe8ac746-b33c-4e12-aaa8-87773a42877f 10544-935 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20150714 ANDA ANDA201807 Blenheim Pharmacal, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-937_1ea0a3ac-8877-48c1-e054-00144ff8d46c 10544-937 HUMAN PRESCRIPTION DRUG valacyclovir hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120405 ANDA ANDA201506 Blenheim Pharmacal, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 10544-938_1bf3b606-e931-5233-e054-00144ff88e88 10544-938 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150727 ANDA ANDA070044 Blenheim Pharmacal, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 10544-939_26a262b0-d022-1e35-e054-00144ff8d46c 10544-939 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20150706 ANDA ANDA091305 Blenheim Pharmacal, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-940_2939404a-596a-02d1-e054-00144ff8d46c 10544-940 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20150908 ANDA ANDA071017 Blenheim Pharmacal, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 10544-941_1ed81758-3e3b-46d2-e054-00144ff88e88 10544-941 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20150901 ANDA ANDA040863 Blenheim Pharmacal, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 10544-943_205a2d2c-5631-10a9-e054-00144ff88e88 10544-943 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 10544-944_1ec86d05-f8ab-684f-e054-00144ff88e88 10544-944 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20150827 ANDA ANDA201991 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-945_1ff373df-bc3c-70d8-e054-00144ff88e88 10544-945 HUMAN PRESCRIPTION DRUG Cephalexin cephalexin CAPSULE ORAL 20150914 ANDA ANDA062713 Blenheim Pharmacal, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-946_1ff373df-bc3c-70d8-e054-00144ff88e88 10544-946 HUMAN PRESCRIPTION DRUG Cephalexin cephalexin CAPSULE ORAL 20150915 ANDA ANDA062713 Blenheim Pharmacal, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10544-947_20f8bc72-14ed-5e23-e054-00144ff8d46c 10544-947 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Blenheim Pharmacal Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-949_219cc0f7-1a9c-689c-e054-00144ff88e88 10544-949 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20151007 ANDA ANDA201089 Blenheim Pharmacal, Inc. DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 10544-950_31a57dee-71d7-1b8f-e054-00144ff88e88 10544-950 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20151007 ANDA ANDA065256 Blenheim Pharmacal, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 10544-951_2173024e-a54c-3521-e054-00144ff8d46c 10544-951 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20151006 ANDA ANDA065093 Blenheim Pharmacal, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 10544-952_dfe82e04-8bae-40a0-b179-5e1f0edaafc9 10544-952 HUMAN PRESCRIPTION DRUG Clarithromycin clarithromycin TABLET, COATED ORAL 20151202 ANDA ANDA065178 Blenheim Pharmacal, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 10544-953_31028c97-a033-6635-e054-00144ff88e88 10544-953 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20151105 ANDA ANDA204197 Blenheim Pharmacal, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-955_3282624b-6a8a-16b4-e054-00144ff8d46c 10544-955 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Delayed-Release Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20140715 ANDA ANDA200540 Blenheim Pharmacal, Inc. DICLOFENAC SODIUM; MISOPROSTOL 75; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 10544-956_5eb54c7b-2566-4570-95db-b39bfaf47d64 10544-956 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20160107 ANDA ANDA040489 Blenheim Pharmacal, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 10544-957_62bf430f-d6f8-440d-a8bf-901e2eaf90c8 10544-957 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20160107 ANDA ANDA203686 Blenheim Pharmacal, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 10544-958_32949847-4166-404f-e054-00144ff88e88 10544-958 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20160115 ANDA ANDA064076 Blenheim Pharmacal, Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 10544-959_32949847-4166-404f-e054-00144ff88e88 10544-959 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20160316 ANDA ANDA064076 Blenheim Pharmacal, Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 10544-967_2b998f03-ab78-0cb6-e054-00144ff8d46c 10544-967 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20160212 NDA AUTHORIZED GENERIC NDA020998 Blenheim Pharmacal, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 10544-968_2b9905c8-1bf2-6d8e-e054-00144ff8d46c 10544-968 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20160211 NDA AUTHORIZED GENERIC NDA021323 Blenheim Pharmacal, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-969_2b9905c8-1bf2-6d8e-e054-00144ff8d46c 10544-969 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20160211 NDA AUTHORIZED GENERIC NDA021323 Blenheim Pharmacal, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 10544-972_2b5cc18d-4358-40dd-e054-00144ff88e88 10544-972 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20160209 ANDA ANDA091672 Blenheim Pharmacal, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 10544-975_3089264e-e4f4-094a-e054-00144ff88e88 10544-975 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 20160412 ANDA ANDA064071 Blenheim Pharmacal, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 10544-979_35f8330a-ab32-13d3-e054-00144ff8d46c 10544-979 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20160623 ANDA ANDA090836 Blenheim Phamacal, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 10546-100_d4255df9-25b6-4373-9b04-827605029434 10546-100 HUMAN OTC DRUG NUMOTIZINE MENTHOL OINTMENT TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part348 Hobart Laboratories, Inc. MENTHOL 1.25 g/100g N 20181231 10565-001_98dbcd61-8221-4f56-8840-49ca765ade3a 10565-001 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 19930901 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories HYDROGEN PEROXIDE 3 mL/100mL N 20191231 10565-002_d5b6e260-c1a9-4de4-802b-69fd4de18e2b 10565-002 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20170505 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ISOPROPYL ALCOHOL 70 mL/100mL N 20191231 10565-040_7d64f306-d35d-4147-9388-56e048aaeaec 10565-040 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20111221 OTC MONOGRAPH FINAL part347 Hydrox Laboratories WITCH HAZEL 86 mg/100mL N 20181231 10565-051_219f3363-a280-499d-b414-ef113693bf5a 10565-051 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20170817 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 10565-066_5452c747-1bfb-46d8-b786-937073fc63e5 10565-066 HUMAN OTC DRUG Roll On Anti Perspirant Alcohol Free ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20111026 OTC MONOGRAPH FINAL part350 Hydrox Laboratories ALUMINUM CHLOROHYDRATE 10 mg/100mL N 20181231 10565-067_a67621b7-30dd-4147-b86c-d3585a96bdc9 10565-067 HUMAN OTC DRUG Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SPRAY TOPICAL 20111111 OTC MONOGRAPH FINAL part350 Hydrox Laboratories ALUMINUM CHLOROHYDRATE 13 mg/100mL N 20181231 10565-071_9002e9b4-bb83-49ed-8b87-ed7aef9fdb21 10565-071 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20170519 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ISOPROPYL ALCOHOL 91 mL/100mL N 20191231 10565-072_aace49a0-c249-4b77-8c1b-3e265e6976eb 10565-072 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol GEL TOPICAL 20111129 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ALCOHOL 62 mL/100mL N 20181231 10565-074_eb5a59f6-7a68-4308-bc8a-b22abc2376c9 10565-074 HUMAN OTC DRUG Anti-Perspirant Deodorant Roll-On Unscented Aluminum Chlorohydrate LIQUID TOPICAL 20120320 OTC MONOGRAPH FINAL part350 Hydrox Laboratories ALUMINUM CHLOROHYDRATE 10 mg/100mL N 20181231 10565-075_924b6ba0-7fa1-414b-add6-aba13a45b7b3 10565-075 HUMAN OTC DRUG Instant Hand Sanitizer Unscented Alcohol GEL TOPICAL 20120321 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ALCOHOL 62 mL/100mL N 20181231 10565-076_aa552217-7b00-49d7-a16b-f330edd36647 10565-076 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol GEL TOPICAL 20120109 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ALCOHOL 62 mL/100mL N 20181231 10565-099_59d93cc1-6778-4b52-b421-8825d994388a 10565-099 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20170616 OTC MONOGRAPH FINAL part347 Hydrox Laboratories WITCH HAZEL 855 mg/mL N 20181231 10565-461_ef9e1303-6037-470f-b339-144d55b86368 10565-461 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic ehtyl alcohol GEL TOPICAL 20170622 OTC MONOGRAPH NOT FINAL part333A Hydrox Laboratories ALCOHOL 70 mL/100mL N 20181231 10565-467_ae0a43f1-fa98-4ccc-a07c-4f62d6116b89 10565-467 HUMAN OTC DRUG Instant Hand Sanitizer Kuretek Alcohol GEL TOPICAL 20120612 OTC MONOGRAPH FINAL part333A Hydrox Laboratories ALCOHOL 62 mL/100mL E 20171231 10565-467_f0fb9e9e-3fc6-4b2a-a0a7-9f2954c098cc 10565-467 HUMAN OTC DRUG Instant Hand Sanitizer Kuretek Alcohol GEL TOPICAL 20120612 OTC MONOGRAPH FINAL part333A Hydrox Laboratories ALCOHOL 62 mL/100mL E 20171231 10565-604_59b72908-fbff-4837-b6ba-3de0aa97ab7e 10565-604 HUMAN OTC DRUG Anti-Perspirant Deodorant Aluminum Chlorohydrate SOLUTION TOPICAL 20170816 20181229 OTC MONOGRAPH FINAL part350 Hydrox Laboratories ALUMINUM CHLOROHYDRATE 10 mg/100mL N 20191231 10565-752_0dea1f5c-557f-42b5-bcbf-74bc39e1890e 10565-752 HUMAN OTC DRUG Roll On Anti Perspirant Alcohol Free ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20171114 OTC MONOGRAPH FINAL part350 Hydrox Laboratories ALUMINUM CHLOROHYDRATE 10 mg/100mL N 20181231 10572-100_907b9c8d-6c74-4a60-8f34-c6447319834a 10572-100 HUMAN PRESCRIPTION DRUG PEG-3350 and Electrolytes Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride POWDER, FOR SOLUTION ORAL 20090701 NDA AUTHORIZED GENERIC NDA019011 Affordable Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 236; 22.74; 6.74; 5.86; 2.97 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 10572-101_907b9c8d-6c74-4a60-8f34-c6447319834a 10572-101 HUMAN PRESCRIPTION DRUG PEG-3350 and Electrolytes Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride POWDER, FOR SOLUTION ORAL 20090701 NDA AUTHORIZED GENERIC NDA019011 Affordable Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 236; 22.74; 6.74; 5.86; 2.97 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 10572-302_dcd1e641-9925-4e25-a1f8-3c30f0839775 10572-302 HUMAN PRESCRIPTION DRUG PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride POWDER, FOR SOLUTION ORAL 20130208 NDA AUTHORIZED GENERIC NDA019797 Affordable Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE 420; 11.2; 5.72; 1.48 g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 10572-400_16fd321d-f891-4083-99f7-26e2e122619c 10572-400 HUMAN PRESCRIPTION DRUG PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride POWDER, FOR SOLUTION ORAL 20130208 NDA AUTHORIZED GENERIC NDA019797 Affordable Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE 420; 11.2; 5.72; 1.48 g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 10578-001_48026595-03db-4b04-94cb-ee6b7d7b59bc 10578-001 HUMAN OTC DRUG Eucamint menthol, camphor OINTMENT TOPICAL 19950101 OTC MONOGRAPH FINAL part341 Indiana Botanic Gardens MENTHOL; CAMPHOR (SYNTHETIC) 2.61; 4.35 g/100g; g/100g E 20171231 10578-002_59617214-dcaf-4695-888d-bd516b3fa743 10578-002 HUMAN OTC DRUG Aloemint Skin Aid menthol OINTMENT TOPICAL 19950101 OTC MONOGRAPH FINAL part348 Indiana Botanic Gardens MENTHOL .31 g/100g E 20171231 10578-003_bedaaf40-3496-4029-8f7e-fd2747f71008 10578-003 HUMAN OTC DRUG Homeopathic Burn White oxide of arsenic, pot marigold, spanish fly, stinging nettle CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARSENIC TRIOXIDE; CALENDULA OFFICINALIS FLOWER; LYTTA VESICATORIA; URTICA URENS 10; 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g E 20171231 10578-004_1a91f2bb-35c0-4a5b-82c5-02a04be2aaaa 10578-004 HUMAN OTC DRUG Homeopathic Bruise Leopards bane, daisy, st. johns wort CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g E 20171231 10578-005_feb71f1b-b24b-4bac-8b1f-5a45b108be36 10578-005 HUMAN OTC DRUG Homeopathic Eczema White oxide of arsenic, barberry, club moss, arbor vitae CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; LYCOPODIUM CLAVATUM SPORE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g E 20171231 10578-006_299016a0-9df9-4224-b8fb-8d3964480801 10578-006 HUMAN OTC DRUG Homeopathic Scar Pot marigold, bushmaster snake, black lead, oil of mustard seed CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CALENDULA OFFICINALIS FLOWER; LACHESIS MUTA VENOM; GRAPHITE; ALLYLTHIOUREA 10; 16; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g E 20171231 10578-007_6e3d019e-006a-41e3-bd99-3ccbd938fd75 10578-007 HUMAN OTC DRUG Homeopathic Acne Potassium hydrate, calcium sulphide, poison nut, cuttlefish ink CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CAUSTICUM; CALCIUM SULFIDE; STRYCHNOS NUX-VOMICA SEED; SEPIA OFFICINALIS JUICE 10; 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g E 20171231 10578-008_a6072d70-8a38-4af3-bb50-69ef78d4fb2d 10578-008 HUMAN OTC DRUG Homeopathic Athletes Foot Carbonate of barium, black lead, pure flint, arbor vitae CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens BARIUM CARBONATE; GRAPHITE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g E 20171231 10578-009_b47f0974-039f-4e18-b1a5-72b4fe282c58 10578-009 HUMAN OTC DRUG Undesine undecylenic acid, zinc undecylenate OINTMENT TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Indiana Botanic Gardens UNDECYLENIC ACID; ZINC UNDECYLENATE 5; 20 g/100g; g/100g E 20171231 10578-010_cb45796c-2421-4d74-856b-5aa253f34d50 10578-010 HUMAN OTC DRUG Homeopathic Weight Loss Formula Betula alba, Cimicifuga racemosa, Cratageus oxycantha, Equisetum hyemale, Rhamnus frangula, Solidago virgaurea, Adonis vernalis, Apocynum androsaemifolium, Chelidonium majus, Lycopodium clavatum, Scil TABLET ORAL 19970401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens BETULA PUBESCENS LEAF; BLACK COHOSH; CRATAEGUS LAEVIGATA FRUIT; EQUISETUM HYEMALE; FRANGULA ALNUS BARK; SOLIDAGO VIRGAUREA FLOWERING TOP; ADONIS VERNALIS; APOCYNUM ANDROSAEMIFOLIUM ROOT; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; DRIMIA MARITIMA BULB 2; 2; 2; 2; 2; 2; 3; 3; 3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-011_59a3d87a-3074-45f0-86fe-bcf0a154c9ba 10578-011 HUMAN OTC DRUG Homeopathic Joint Formula Benzoic acid, Bryonia alba, Ruta graveolens, Rhus toxicodendron, Causticum, Formic acid, Lithium carbonicum TABLET ORAL 20030101 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens BENZOIC ACID; BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; CAUSTICUM; FORMIC ACID; LITHIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 6; 6; 6; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-012_108bf8ba-d8a4-49ea-850d-9a60d6fa01d6 10578-012 HUMAN OTC DRUG Homeopathic Leg Cramp Formula Anacardium orientale, Cocculus indicus, Gelsemium sempervirens, Lycopodium clavatum, Causticum, Cuprum metallicum, Magnesia phosphorica TABLET ORAL 19980201 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens SEMECARPUS ANACARDIUM JUICE; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; CAUSTICUM; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 2; 2; 3; 3; 4; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-013_dfb9c3be-7005-4847-a9e6-12ae5ae3c76d 10578-013 HUMAN OTC DRUG Homeopathic Sciatica Formula Arnica montana, Hypericum perforatum, Gnaphalium, Kali iodatum, Magnesia phosphorica, Rhus toxicodendron TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; HYPERICUM PERFORATUM; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; POTASSIUM IODIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 4; 5; 6; 5; 5; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-014_44819e40-1ce9-42f7-8be7-6a75f30279bb 10578-014 HUMAN OTC DRUG Homeopathic Ringing Ear Formula China sulphuricum, Thiosinaminum, Petroselinum, Salicylic acid, Kali phosphoricum TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens QUININE SULFATE; SALICYLIC ACID; ALLYLTHIOUREA; PETROSELINUM CRISPUM; POTASSIUM PHOSPHATE, DIBASIC 6; 5; 3; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-015_5d99ee48-c2d2-4ebc-8daf-747dbbc13117 10578-015 HUMAN OTC DRUG Homeopathic Bladder Confidence Formula Belladonna, Canthris, Apis mellifica, Arnica montana, Allium cepa, Rhus aromatica, Equisetum hyemale TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ATROPA BELLADONNA; APIS MELLIFERA; LYTTA VESICATORIA; ARNICA MONTANA; ONION; RHUS AROMATICA ROOT BARK; EQUISETUM HYEMALE 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-016_b2522c50-e13a-487b-aef9-113ce3b13da9 10578-016 HUMAN OTC DRUG Homeopathic Allergy Formula allium cepa, apis mellifica, arsenicum album, euphrasia officinalis, Nux vomica TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ONION; APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED 4; 4; 4; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-017_b3c4748e-71c2-42cc-aa29-d0dbc9b8df34 10578-017 HUMAN OTC DRUG Homeopathic Hemorrhoid Horse chestnut, potassium hydrate, witch hazel, cramp bark CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens HORSE CHESTNUT; CAUSTICUM; WITCH HAZEL; VIBURNUM OPULUS BARK 10; 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g E 20171231 10578-018_9600f376-9f01-4818-a140-f605aa1df579 10578-018 HUMAN OTC DRUG Homeopathic Gas Relief Formula Carduus marianus, Chelidonium majus, Solidago virgaurea, Taraxacum officinalis, Chinchona officinalis, Hydrastis canadensis, Nux vomica TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens MILK THISTLE; CHELIDONIUM MAJUS; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; CINCHONA OFFICINALIS BARK; GOLDENSEAL; STRYCHNOS NUX-VOMICA SEED 3; 3; 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-019_16079903-ee27-4084-9ddd-ddd74d82de2d 10578-019 HUMAN OTC DRUG Homeopathic Low Back Pain Formula Colocynthis, Antimonium tartrate, Kali carbonate, Bryonia, Nux vomica TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CITRULLUS COLOCYNTHIS FRUIT PULP; ANTIMONY POTASSIUM TARTRATE; POTASSIUM CARBONATE; BRYONIA ALBA ROOT; STRYCHNOS NUX-VOMICA SEED 3; 3; 6; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-020_3a5c0f68-badd-4ef2-b411-8ff5e2864f7c 10578-020 HUMAN OTC DRUG Homeopathic Rheumatism Barberry, potassium hydrate, buttercup, poison oak CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens BERBERIS VULGARIS ROOT BARK; CAUSTICUM; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g E 20171231 10578-021_5abadf50-37ae-4fa7-aa36-84e194a69e1a 10578-021 HUMAN OTC DRUG Homeopathic Wart Sulphide of antimony, potassium hydrate, woody nightshade, arbor vitae CREAM TOPICAL 20120427 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ANTIMONY TRISULFIDE; CAUSTICUM; SOLANUM DULCAMARA TOP; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g; [hp_X]/28g E 20171231 10578-022_f5e75b25-9668-4cd0-8fe5-5fd9b5257255 10578-022 HUMAN OTC DRUG Homeopathic Sinus Relief Formula Allium cepa, Belladonna, Euphrasia officinale, Hydrastis canadensis, Kali bechromate, Sambucus niger, Mercurius dulcis TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ONION; ATROPA BELLADONNA; EUPHRASIA STRICTA; GOLDENSEAL; POTASSIUM DICHROMATE; SAMBUCUS NIGRA FLOWERING TOP; CALOMEL 3; 3; 3; 3; 3; 3; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-023_2338bdac-73af-4096-9a4f-bb7c6f0c04ad 10578-023 HUMAN OTC DRUG Homeopathic Stop Smoking Formula Daphne indica, Eugenia jambosa, Caladium seguinum, Staphysagria, Anacardium orientale, Nux vomica, Tabaccum TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens DAPHNE ODORA BARK; SYZYGIUM JAMBOS SEED; DIEFFENBACHIA SEGUINE; DELPHINIUM STAPHISAGRIA SEED; SEMECARPUS ANACARDIUM JUICE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 4; 3; 4; 4; 4; 4; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-024_e843efa5-359a-4cf2-9576-b44d590e682e 10578-024 HUMAN OTC DRUG Homeopathic Sleep Formula Avena sativa, Chamomilla vulgaris, Humulus lupulus, Passiflora incarnata, Coffea cruda, Ignatia amara TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; HOPS; PASSIFLORA INCARNATA TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED 3; 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-025_483fc475-935a-4d1d-99e7-b5b283f34aa0 10578-025 HUMAN OTC DRUG Homeopathic Acne Formula Arsenicum album, Nitricum acidum, Hepar sulfuris calcarea, Eugenia jambosa, Aurum metallicum, Calcarea suflruica, Solidago virgaurea, Hydrastis canadensis TABLET ORAL 20030101 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARSENIC TRIOXIDE; NITRIC ACID; CALCIUM SULFIDE; SYZYGIUM JAMBOS SEED; GOLD; CALCIUM SULFATE ANHYDROUS; SOLIDAGO VIRGAUREA FLOWERING TOP; GOLDENSEAL 4; 4; 6; 3; 6; 5; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-026_3c0a8311-994b-4e77-a47f-1be1f659c5a3 10578-026 HUMAN OTC DRUG Homeopathic Tension Headache Formula Yellow jasmine, st ignatius bean, carbonate of sodium, poison nut, phosphoric acid TABLET ORAL 20120630 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 5; 5; 5; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-027_1958acdd-61d7-4040-849f-225303a70bc1 10578-027 HUMAN OTC DRUG Homeopathic Diarrhea Formula Aloe socotrina, Antimonium cruda, Arsenicum album, Belladonna, Bryonia album, Chamomilla, Colocynthis, Podophyllum peltatum, Veratrum album TABLET ORAL 20030101 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ALOE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; PODOPHYLLUM; VERATRUM ALBUM ROOT 3; 3; 3; 3; 4; 4; 4; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-028_ab4649f2-fcb1-49b3-8163-943ee481b005 10578-028 HUMAN OTC DRUG Homeopathic Nerve Pain Leopards bane, deadly nightshade, wild hops, yellow jasmine, poison oak TABLET ORAL 20130401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-029_ba42e456-d62e-41dc-a555-747d8b7d3b9f 10578-029 HUMAN OTC DRUG Homeopathic Constipation Relief Oxide of aluminum, wild hops, goldenseal root, magnesium chloride, poison nut TABLET ORAL 20130401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ALUMINUM OXIDE; BRYONIA ALBA ROOT; GOLDENSEAL; MAGNESIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-030_457beec8-26b0-4625-b690-ec1e46047118 10578-030 HUMAN OTC DRUG Homeopathic Motion Sickness Deadly nightshade, indian cockle, ipecac root, poison nut, crude rock-oil TABLET ORAL 20130401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ATROPA BELLADONNA; ANAMIRTA COCCULUS SEED; IPECAC; STRYCHNOS NUX-VOMICA SEED; LIQUID PETROLEUM 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-031_ab73212e-fcb0-42c3-a63d-feb19c92a488 10578-031 HUMAN OTC DRUG Homeopathic Fatigue Formula leopards bane, oat straw, st ignatius bean, phosphoric acid TABLET ORAL 20131001 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; PHOSPHORIC ACID 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-032_01710fb2-7d14-457b-9a81-d4c9da51bd29 10578-032 HUMAN OTC DRUG Homeopathic Mental Alertness Formula Agnus castus, Ambra grisea, Nux vomica, Phosphoricum acidum, Zincum metallicum TABLET ORAL 20030101 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CHASTE TREE; AMBERGRIS; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; ZINC 4; 4; 4; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-033_e20548b6-c45b-40ff-9f2d-7b01c6b9ecea 10578-033 HUMAN OTC DRUG Homeopathic Eye Strain silver nitrate, eyebright, carbonate of potassium, garden rue TABLET ORAL 20131001 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens SILVER NITRATE; EUPHRASIA STRICTA; POTASSIUM CARBONATE; RUTA GRAVEOLENS FLOWERING TOP 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-034_688015aa-c274-4bf4-b700-3e68931d87d7 10578-034 HUMAN OTC DRUG Homeopathic Sore Throat Formula purple cone flower, honey bee, deadly nightshade, sundew, wormseed TABLET ORAL 20140401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ECHINACEA ANGUSTIFOLIA; APIS MELLIFERA; ATROPA BELLADONNA; DROSERA ROTUNDIFOLIA; ARTEMISIA CINA PRE-FLOWERING TOP 6; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-035_62d551fd-f9f3-4b00-a07a-db2556661003 10578-035 HUMAN OTC DRUG Dr. Blue menthol GEL TOPICAL 20030401 OTC MONOGRAPH NOT FINAL part348 Indiana Botanic Gardens MENTHOL 3.89 g/100g E 20171231 10578-036_c59a2ce6-48cb-4370-bc68-29019fbdefda 10578-036 HUMAN OTC DRUG Homeopathic Bronchitis Formula Asclepias tuberose, Drosera rotundifolia, Hepar sulphuris calcareum, Silicea, Stannum metallicum TABLET ORAL 20100630 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ASCLEPIAS TUBEROSA FLOWERING TOP; DROSERA ROTUNDIFOLIA; CALCIUM SULFIDE; SILICON DIOXIDE; TIN 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-037_b30c203c-0ebf-4157-bc86-f45f33cf871a 10578-037 HUMAN OTC DRUG Homeopathic Yeast Relief Formula Candida albicans, Pulsatilla, Sepia, Thuja occidentalis TABLET ORAL 20090401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CANDIDA ALBICANS; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG; SEPIA OFFICINALIS JUICE 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-038_78289343-a6ab-487c-bdfb-86aef8727d43 10578-038 HUMAN OTC DRUG Homeopathic Skin Solutions Formula Nux vomica, Kali arsenicum, Berberis vulgaris, Graphites, Arsenicum album, Hepar sulphuris calcareum, Arsenicum sulphuratum rubrum TABLET ORAL 20030901 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens STRYCHNOS NUX-VOMICA SEED; POTASSIUM ARSENITE ANHYDROUS; BERBERIS VULGARIS ROOT BARK; GRAPHITE; ARSENIC TRIOXIDE; CALCIUM SULFIDE; TETRAARSENIC TETRASULFIDE 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-039_a9b6e512-6179-489c-a067-78ce0f3eaaed 10578-039 HUMAN OTC DRUG Homeopathic Cold and Flu Formula Aconitium napellus, Belladonna, Echinacea angustifolia, Eupatorium perfoliatum, Gelsemium sempervirens, Ferrum phosphoricum, Influenzinum TABLET ORAL 20010101 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ACONITUM NAPELLUS; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; FERRUM PHOSPHORICUM; HAEMOPHILUS INFLUENZAE TYPE B 6; 6; 6; 6; 6; 8; 200 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 E 20171231 10578-040_8d60f5aa-a709-4ed6-b468-3909c54daefa 10578-040 HUMAN OTC DRUG Painzaway Balm camphor OINTMENT TOPICAL 20011201 OTC MONOGRAPH NOT FINAL part348 Indiana Botanic Gardens CAMPHOR (SYNTHETIC) 4 g/100g E 20171231 10578-041_c258b145-2b4c-427a-b312-825bb27e459a 10578-041 HUMAN OTC DRUG Homeopathic Lymphatic Clear Formula Calcarea carbonica, Conium maculatum, Hepar sulphuris calcareum, Rhus toxicodendron, Silicea TABLET ORAL 20090401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; CALCIUM SULFIDE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-042_270a632a-01d6-444b-b025-930ad317cb6f 10578-042 HUMAN OTC DRUG Homeopathic Fear and Anxiety Formula Aconite napellus, Argentums nitricum, Gelsemium sempervirens, Hyoscyamus niger, Ignatia amara, Lycopodium clavatum, Phosphorus TABLET ORAL 20100630 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ACONITUM NAPELLUS; SILVER NITRATE; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-043_12ceaacd-96a1-41b6-9b23-a50f614a65d8 10578-043 HUMAN OTC DRUG Homeopathic Yeast Relief Formula Candida albicans, Pulsatilla, Sepia, Thuja occidentalis TABLET ORAL 20090401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CANDIDA ALBICANS; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG; SEPIA OFFICINALIS JUICE 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-044_c59ed3ec-f800-49c1-a52d-c794a1705726 10578-044 HUMAN OTC DRUG Homeopathic Trauma Formula Arnica montana, Belladonna, Calendula officinalis, Echinacea angustafolia, Hypericum perforatum, Ruta graveolens, Symphytum officinalis TABLET ORAL 20010301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-045_4edf2cbe-07e6-43dd-ba59-0b086af6ff98 10578-045 HUMAN OTC DRUG Homeopathic Facial Redness Formula Belladonna, Calcarea silicate, Lachesis mutus, Phophorus, Nux vomica, Sepia, Sulphuricum acidum TABLET ORAL 20090401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CALCIUM SILICATE; ATROPA BELLADONNA; LACHESIS MUTA VENOM; PHOSPHORUS; STRYCHNOS NUX-VOMICA SEED; SEPIA OFFICINALIS JUICE; SULFURIC ACID 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-046_78652264-87c0-454e-ad13-2c321a04e6c1 10578-046 HUMAN OTC DRUG Homeopathic Periodontal Gum Relief Formula Belladonna, Sodium borate, Hepar sulphuris calcareum, Nitricum acidum TABLET ORAL 20090401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ATROPA BELLADONNA; SODIUM BORATE; CALCIUM SULFIDE; NITRIC ACID 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-047_5e08ba82-4dfa-48c2-8acf-b4bea9da6d90 10578-047 HUMAN OTC DRUG Homeopathic Hangover Formula Antimonium crudum, Bryonia alba, Nux vomica, Ranunculus bulbosus, Zincum metallicum TABLET ORAL 20030101 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; STRYCHNOS NUX-VOMICA SEED; RANUNCULUS BULBOSUS; ZINC 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-048_59de25fc-e58f-47a8-9bba-58af1626b760 10578-048 HUMAN OTC DRUG Homeopathic Ear Ache Formula Aconitum napellus, Belladonna, Capsicum, Chamomile, Ferrum phosphoricum, Kali muriaticum TABLET ORAL 20090401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ACONITUM NAPELLUS; ATROPA BELLADONNA; CAPSICUM; CHAMOMILE; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-050_09647e2a-8e8c-4bb6-9890-72bf64bc6c7b 10578-050 HUMAN OTC DRUG Homeopathic Thyroid Formula Fucus vesiculosus, Lycopodium clavatum, Natrum muriaticum, Spongia tosta, Thyroidinum TABLET ORAL 20100630 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens FUCUS VESICULOSUS; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID 30; 30; 30; 30; 7 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-051_e1d59cb3-2489-4299-b1e9-57f46230feca 10578-051 HUMAN OTC DRUG Homeopathic Muscle Pain and Stiffness Formula Arnica montana, Badiaga, Bellis perennis, Bryonia, Causticum, Rhus toxicodendron TABLET ORAL 20100630 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; SPONGILLA LACUSTRIS; BELLIS PERENNIS; BRYONIA ALBA ROOT; CAUSTICUM; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-052_aacb3393-ee2d-475c-925f-79a9fa2c015e 10578-052 HUMAN OTC DRUG Homeopathic Cold and Canker Sore Formula Antimonum crudum, Apis mellifica, Cuprum metallicum, Euphorbia lathyris, Rhus toxicodendron TABLET ORAL 20100707 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ANTIMONY TRISULFIDE; APIS MELLIFERA; COPPER; EUPHORBIA LATHYRIS; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-053_f09d90bd-3447-4db8-8fa0-d6ddd74375f0 10578-053 HUMAN OTC DRUG Homeopathic Perspiration Formula Tartaremetic, carbonate lime, vegetable charcoal, pure flint, sulphur TABLET ORAL 20140401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ANTIMONY POTASSIUM TARTRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; SILICON DIOXIDE; SULFUR 8; 8; 8; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-054_3e840f9d-16f7-4a50-8f33-1724550faaf6 10578-054 HUMAN OTC DRUG Homeopathic Womens Libido chastetree, oatstraw, potassium hydrate, common salt, cuttle fish TABLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CHASTE TREE; AVENA SATIVA FLOWERING TOP; CAUSTICUM; SODIUM CHLORIDE; SEPIA OFFICINALIS JUICE 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-055_a2203138-3770-4445-9b4d-ca444aa75897 10578-055 HUMAN OTC DRUG Neuro Support Plus Foot Balm camphor OINTMENT TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part348 Indiana Botanic Gardens CAMPHOR (SYNTHETIC) 4 g/100g E 20171231 10578-100_fc58122e-be15-451b-9250-297658bca8eb 10578-100 HUMAN OTC DRUG Homeopathic Nerve Pain Leopards bane, deadly nightshade, wild hops, yellow jasmine, poison oak TABLET ORAL 20150608 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-101_9b6c18d3-49aa-4811-ab82-4337e2efe16f 10578-101 HUMAN OTC DRUG Homeopathic Allergy Relief red onion, honeybee, arsenic trioxide, eyebright, poison nut TABLET ORAL 20150812 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ONION; APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED 4; 4; 4; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-102_0fd2f907-a2c3-4662-a6b3-e33652c9d0ce 10578-102 HUMAN OTC DRUG Homeopathic Bladder Confidence Deadly nightshade, Spanish fly, Honeybee, Mountain arnica, Red onion, Fragrant sumac, Horsetail TABLET ORAL 20150810 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ATROPA BELLADONNA; LYTTA VESICATORIA; APIS MELLIFERA; ARNICA MONTANA; ONION; RHUS AROMATICA ROOT BARK; EQUISETUM HYEMALE 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-103_c225b587-b6f2-4ba9-a330-10e621a2180f 10578-103 HUMAN OTC DRUG Homeopathic Cold and Flu Aconite, Deadly nightshade, Purple cone flower, Boneset, Yellow jasmine, Phosphate of iron, Influenza virus vaccine TABLET ORAL 20160118 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ACONITUM NAPELLUS; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; FERROSOFERRIC PHOSPHATE; HAEMOPHILUS INFLUENZAE TYPE B 6; 6; 6; 6; 6; 8; 200 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 E 20171231 10578-104_7d4b222f-8c4c-4810-82ff-5b53e3b5d4d0 10578-104 HUMAN OTC DRUG Homeopathic Fear and Anxiety Formula Aconite, Silver nitrate, Yellow jasmine, Henbane, Ignatius bean, Clubmoss, Phosphorus TABLET ORAL 20150818 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ACONITUM NAPELLUS; SILVER NITRATE; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-105_bc35ee0c-3440-41ad-ba55-5ea741aa4aea 10578-105 HUMAN OTC DRUG Homeopathic Gas/Bloating Milk Thistle, Greater celandine, Goldenrod, Dandelion, Cinchona, Goldenseal, Poison nut TABLET ORAL 20150817 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens MILK THISTLE; CHELIDONIUM MAJUS; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; CINCHONA OFFICINALIS BARK; GOLDENSEAL; STRYCHNOS NUX-VOMICA SEED 3; 3; 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-106_3330ff31-e398-4f2f-8b8e-bcd4ef371955 10578-106 HUMAN OTC DRUG Homeopathic Leg Cramp Formula Marking nut, Fish berry, Yellow jasmine, Clubmoss, Hahnemanns causticum, Copper, Magnesium phosphate TABLET ORAL 20150720 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens SEMECARPUS ANACARDIUM JUICE; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; CAUSTICUM; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 2; 2; 3; 3; 4; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-107_e8d7647f-0b9d-45cb-97b0-0474fb9153a0 10578-107 HUMAN OTC DRUG Homeopathic Mental Alertness Wild lavender, Ambrergris, Poison nut, Phosphoric Acid, Zinc TABLET ORAL 20150901 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CHASTE TREE; AMBERGRIS; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; ZINC 4; 4; 4; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-108_6b4b218f-7cce-4d94-8616-fbb06135fc85 10578-108 HUMAN OTC DRUG Homeopathic Ringing Ear Formula Oil of mustard seed, Parsley, Potassium phosphate, Salicylic acid, Quinine sulphate TABLET ORAL 20150930 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ALLYLTHIOUREA; PETROSELINUM CRISPUM; POTASSIUM PHOSPHATE, DIBASIC; SALICYLIC ACID; QUININE SULFATE 3; 3; 3; 5; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-109_1a34744f-e377-4976-9cf3-159eafa53785 10578-109 HUMAN OTC DRUG Homeopathic Sciatica Mountain tobacco, St johns wort, old balsam, potassium iodide, Magnesium phosphate, poison oak TABLET ORAL 20150901 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; HYPERICUM PERFORATUM; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; POTASSIUM IODIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 4; 5; 6; 5; 5; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-110_1c7b31e5-9d9a-4b30-bed2-3b6ba3cf4ab2 10578-110 HUMAN OTC DRUG Homeopathic Sleep Oatstraw, Chamomile, Hops, Passion flower, Green coffee, Ignatius bean TABLET ORAL 20150810 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; HOPS; PASSIFLORA INCARNATA FLOWERING TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED 3; 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-111_3b843c98-9c2c-4acc-a160-e72c0dc0419c 10578-111 HUMAN OTC DRUG Homeopathic Constipation Relief Formula Oxide of aluminum, wild hops, goldenseal root, magnesium chloride, poison nut TABLET ORAL 20150819 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ALUMINUM OXIDE; BRYONIA ALBA ROOT; GOLDENSEAL; MAGNESIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-112_0cddcb23-e307-43af-8f51-3afc989204b0 10578-112 HUMAN OTC DRUG Homeopathic Fatigue Formula leopards bane, oat straw, st ignatius bean, phosphoric acid TABLET ORAL 20150820 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; PHOSPHORIC ACID 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-113_27de07b0-223d-490e-b16e-054d8ef131f8 10578-113 HUMAN OTC DRUG Homeopathic Joint Benzoic acid, Wild hops, Rue, Poison ivy, Potassium hydrate, Formic acid, Lithium carbonate TABLET ORAL 20150901 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens BENZOIC ACID; BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; CAUSTICUM; FORMIC ACID; LITHIUM CARBONATE 3; 3; 3; 3; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-114_ff165cb5-1570-40ab-81ed-50ab2dc63228 10578-114 HUMAN OTC DRUG Homeopathic Low Back Pain Bitter cucumber, Antimony potassium tartrate, Wild hops, Poison nut, Anhydrous potassium carbonate TABLET ORAL 20151022 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CITRULLUS COLOCYNTHIS FRUIT PULP; ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; STRYCHNOS NUX-VOMICA SEED; POTASSIUM CARBONATE 3; 3; 4; 4; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-115_83872317-45ff-453a-b2db-8c67f78724c8 10578-115 HUMAN OTC DRUG Homeopathic Cold/Canker Sores Antimony trisulfide, Honeybee, Copper, Gopher plant, Poison oak TABLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ANTIMONY TRISULFIDE; APIS MELLIFERA; COPPER; EUPHORBIA LATHYRIS; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-116_3f084908-a428-4903-958b-69e38282f2cc 10578-116 HUMAN OTC DRUG Homeopathic Womens Libido chastetree, oatstraw, potassium hydrate, common salt, cuttle fish TABLET ORAL 20160224 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CHASTE TREE; AVENA SATIVA FLOWERING TOP; CAUSTICUM; SODIUM CHLORIDE; SEPIA OFFICINALIS JUICE 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-117_ba6a5c3b-b86d-4a85-bcbd-7dbcbd4902a0 10578-117 HUMAN OTC DRUG Homeopathic Sinus Relief Red onion, Deadly nightshade, Eyebright, Goldenseal, Potassium dichromate, Mercurous chloride, European elder TABLET ORAL 20151026 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ONION; ATROPA BELLADONNA; EUPHRASIA STRICTA; GOLDENSEAL; POTASSIUM DICHROMATE; CALOMEL; SAMBUCUS NIGRA FLOWERING TOP 3; 3; 3; 3; 3; 6; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-118_4fc7a51f-667d-4d66-992f-6c00a620a008 10578-118 HUMAN OTC DRUG Homeopathic Yeast Relief Formula Candida albicans, Wind flower, Cuttlefish ink, White cedar TABLET ORAL 20160301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens CANDIDA ALBICANS; ANEMONE PULSATILLA; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 10578-119_6c57b654-1848-461d-92e3-7243baa2c3e6 10578-119 HUMAN OTC DRUG Homeopathic Restless Leg Formula White oxide of arsenic, potassium hydrate, Carbonate of potassium, club moss, poison oak TABLET ORAL 20160301 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARSENIC TRIOXIDE; CAUSTICUM; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF 4; 4; 4; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-121_dfd62568-6293-4913-b993-54f0ebc7045b 10578-121 HUMAN OTC DRUG Painzaway Homeopathic Formula Mountain tobacco, Freshwater sponge, Daisy, Wild hops, Hahnemanns causticum , Poison Ivy TABLET ORAL 20160401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ARNICA MONTANA; SPONGILLA LACUSTRIS; BELLIS PERENNIS; BRYONIA ALBA ROOT; CAUSTICUM; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-122_fe0dbf08-2a51-40aa-bfbd-51890003e2aa 10578-122 HUMAN OTC DRUG Homeopathic Lymphatic Clear Formula Impure calcium carbonate, Poison hemlock, Impure calcium sulfide, Poison oak, Silica TABLET ORAL 20160401 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; CALCIUM SULFIDE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-127_10eb98b0-e889-48b7-819c-2e74ac7b1641 10578-127 HUMAN OTC DRUG Homeopathic Sinus Relief Red onion, Deadly nightshade, Eyebright, Potassium bichromate, Calomel, European elder, Arbor vitae TABLET ORAL 20160825 UNAPPROVED HOMEOPATHIC Indiana Botanic Gardens ONION; ATROPA BELLADONNA; EUPHRASIA STRICTA; POTASSIUM DICHROMATE; CALOMEL; SAMBUCUS NIGRA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 6; 3; 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 10578-131_3b057467-ca8c-48c2-99ad-80a012b5f74b 10578-131 HUMAN OTC DRUG Dr. Blue menthol GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part348 Indiana Botanic Gardens MENTHOL 4.58 g/100g E 20171231 10586-9102_f6ac75f3-5ba0-44cf-bcf3-137eebb04f11 10586-9102 HUMAN OTC DRUG Instant Hand Sanitizer - Vanilla Scented ALCOHOL LIQUID TOPICAL 20111102 OTC MONOGRAPH FINAL part333E Core Brands, Inc. ALCOHOL 62 mL/100mL E 20171231 10586-9103_a0f75b3b-81b1-425b-b65e-bf0b3de6566c 10586-9103 HUMAN OTC DRUG Instant Hand Sanitizer - Original ALCOHOL LIQUID TOPICAL 20111102 OTC MONOGRAPH FINAL part333E Core Brands, Inc. ALCOHOL 62 mL/100mL E 20171231 10586-9104_ada3b9c2-3bb4-423a-9ead-f906d712a05f 10586-9104 HUMAN OTC DRUG Instant Hand Sanitizer - Vanilla Scented ALCOHOL LIQUID TOPICAL 20111102 OTC MONOGRAPH FINAL part333E Core Brands, Inc. ALCOHOL 62 mL/100mL E 20171231 10586-9105_003f51a6-9222-457f-b419-420026a60144 10586-9105 HUMAN OTC DRUG Instant Hand Sanitizer - Strawberry Scented ALCOHOL LIQUID TOPICAL 20111102 OTC MONOGRAPH FINAL part333E Core Brands, Inc. ALCOHOL 62 mL/100mL E 20171231 10586-9106_f3fbfe81-a177-463c-bcff-169aff11bfa4 10586-9106 HUMAN OTC DRUG Instant Hand Sanitizer - Original ALCOHOL LIQUID TOPICAL 20111102 OTC MONOGRAPH FINAL part333E Core Brands, Inc. ALCOHOL 62 mL/100mL E 20171231 10590-0001_86d5624a-5147-48b8-b59f-775591bd01ad 10590-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19440101 UNAPPROVED MEDICAL GAS Jackson Welding Supply Company, Inc OXYGEN 99 L/100L N 20181231 10596-132_5efbf63b-cb74-55f7-e053-2a91aa0a6a05 10596-132 HUMAN OTC DRUG Biore Blemish Treating Astringent SALICYLIC ACID LIQUID TOPICAL 20111109 OTC MONOGRAPH FINAL part333D Kao USA Inc. SALICYLIC ACID 4.56 g/236mL N 20181231 10596-153_3760597f-2c47-3fcc-e054-00144ff88e88 10596-153 HUMAN OTC DRUG Biore Warming Anti-Blackhead Cleanser SALICYLIC ACID LIQUID TOPICAL 20111228 OTC MONOGRAPH FINAL part333D Kao USA Inc. SALICYLIC ACID 2.54 g/127g N 20181231 10596-159_505ee941-2921-35e4-e054-00144ff88e88 10596-159 HUMAN OTC DRUG Biore Blemish Fighting Ice Cleanser SALICYLIC ACID LIQUID TOPICAL 20111228 OTC MONOGRAPH FINAL part333D Kao USA Inc. SALICYLIC ACID 4.3 g/200mL N 20181231 10596-161_5cdd5ea4-94ea-5333-e053-2a91aa0ae9c2 10596-161 HUMAN OTC DRUG Biore Pore Unclogging Scrub SALICYLIC ACID LIQUID TOPICAL 20111228 OTC MONOGRAPH FINAL part333D Kao USA Inc. SALICYLIC ACID 2.8 g/141g N 20181231 10596-162_38dfe051-28f4-246d-e054-00144ff88e88 10596-162 HUMAN OTC DRUG Biore Acne Clearing Scrub SALICYLIC ACID GEL TOPICAL 20120101 OTC MONOGRAPH FINAL part333D Kao USA Inc. SALICYLIC ACID 1.27 g/127g N 20181231 10596-183_5cddf6e9-0d46-4275-e053-2991aa0aa54f 10596-183 HUMAN OTC DRUG Biore Baking Soda Acne Scrub SALICYLIC ACID GEL TOPICAL 20161201 OTC MONOGRAPH FINAL part333D Kao USA Inc. SALICYLIC ACID 2.5 g/127g N 20181231 10596-184_5cde2bc1-d53e-5347-e053-2991aa0a7b6f 10596-184 HUMAN OTC DRUG Biore Charcoal Acne Scrub SALICYLIC ACID GEL TOPICAL 20161201 OTC MONOGRAPH FINAL part333D Kao USA Inc. SALICYLIC ACID 1.3 g/127g N 20181231 10596-185_3d80f2d7-b4ed-2951-e054-00144ff8d46c 10596-185 HUMAN OTC DRUG Biore Charcoal Acne Clearing Cleanser SALICYLIC ACID GEL TOPICAL 20161201 OTC MONOGRAPH FINAL part333D Kao USA Inc. SALICYLIC ACID 2 g/200mL N 20181231 10596-186_5d01a361-0955-f1d7-e053-2991aa0a073f 10596-186 HUMAN OTC DRUG Biore Baking Soda Acne Cleansing Foam SALICYLIC ACID GEL TOPICAL 20171116 OTC MONOGRAPH FINAL part333D Kao USA Inc. SALICYLIC ACID .5 g/100mL N 20181231 10596-331_338457c6-a4d4-1708-e054-00144ff88e88 10596-331 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Powder Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao USA Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g N 20181231 10596-333_5049bf25-2340-5cc6-e054-00144ff8d46c 10596-333 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Shower Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao USA Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g N 20181231 10596-334_33d80a89-6d5e-22e0-e054-00144ff8d46c 10596-334 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Sweet Simplicity ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao USA Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g N 20181231 10596-335_33d96fde-3c36-5110-e054-00144ff8d46c 10596-335 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Unscented ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Kao USA Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g N 20181231 10596-336_50499ec2-b75e-561b-e054-00144ff8d46c 10596-336 HUMAN OTC DRUG Ban Roll-On Antiperspirant Deodorant Regular Aluminum Chlorohydrate LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Kao USA Inc. ALUMINUM CHLOROHYDRATE 20 g/103mL N 20181231 10596-337_3e5fda0e-a6e4-6f1e-e054-00144ff88e88 10596-337 HUMAN OTC DRUG Ban Roll-On Antiperspirant Deodorant Powder Fresh Aluminum Chlorohydrate LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Kao USA Inc. ALUMINUM CHLOROHYDRATE 20 g/103mL N 20181231 10596-338_40803aff-f752-6483-e054-00144ff88e88 10596-338 HUMAN OTC DRUG Ban Roll-On Antiperspirant Deodorant Unscented Aluminum Chlorohydrate LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Kao USA Inc. ALUMINUM CHLOROHYDRATE 20 g/103mL N 20181231 10596-339_3ae971e3-30c7-4aac-e054-00144ff88e88 10596-339 HUMAN OTC DRUG Ban Roll-On Antiperspirant Deodorant Satin Breeze Aluminum Chlorohydrate LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Kao USA Inc. ALUMINUM CHLOROHYDRATE 20 g/103mL N 20181231 10596-340_504a21b2-b30b-1a7f-e054-00144ff88e88 10596-340 HUMAN OTC DRUG Ban Roll-On Antiperspirant Deodorant Fresh Cotton Aluminum Chlorohydrate LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part350 Kao USA Inc. ALUMINUM CHLOROHYDRATE 20 g/103mL N 20181231 10596-400_3aea172c-1b7a-62c2-e054-00144ff88e88 10596-400 HUMAN OTC DRUG Ban Roll-On Antiperspirant Deodorant Simple Clean Aluminum Chlorohydrate LIQUID TOPICAL 20111108 OTC MONOGRAPH FINAL part350 Kao USA Inc ALUMINUM CHLOROHYDRATE 20 g/103mL N 20181231 10596-401_34dc8c79-45d5-7448-e054-00144ff88e88 10596-401 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Simply Clean ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20141020 OTC MONOGRAPH FINAL part350 Kao USA Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g N 20181231 10596-402_5d08ba4d-87c7-eed5-e053-2991aa0acc7d 10596-402 HUMAN OTC DRUG Ban Purely Gentle Roll-On Antiperspirant Deodorant Unscented Aluminum Chlorohydrate LIQUID TOPICAL 20180101 OTC MONOGRAPH FINAL part350 Kao USA Inc. ALUMINUM CHLOROHYDRATE 18 g/100mL N 20181231 10596-710_3478d5b8-70fd-2b42-e054-00144ff88e88 10596-710 HUMAN OTC DRUG Jergens Natural Glow Daily Moisturizer with Sunscreen SPF 20 Avobenzone,Octisalate, Octocrylene LOTION TOPICAL 20150409 OTC MONOGRAPH NOT FINAL part352 Kao USA Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 2.2; 8.8; 1.9 g/177mL; g/177mL; g/177mL N 20181231 10596-714_365a98e0-737c-12b3-e054-00144ff8d46c 10596-714 HUMAN OTC DRUG Jergens Natural Glow Face Daily Moisturizer for Fair/Medium Skin Avobenzone, Octisalate, Octocrylene LOTION TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part352 Kao USA Inc. AVOBENZONE; OCTOCRYLENE; OCTISALATE .74; .65; 2.95 g/59mL; g/59mL; g/59mL N 20181231 10596-715_365bb060-52e8-5324-e054-00144ff88e88 10596-715 HUMAN OTC DRUG Jergens Natural Glow Face Daily Moisturizer for Medium/Tan Skin Avobenzone,Octisalate, Octocrylene LOTION TOPICAL 20150223 OTC MONOGRAPH NOT FINAL part352 Kao USA Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE .74; 2.95; .65 g/59mL; g/59mL; g/59mL N 20181231 10597-559_5108bdca-1454-4353-b55f-e31da8ed4f4f 10597-559 HUMAN OTC DRUG Fasprin Aspirin TABLET, ORALLY DISINTEGRATING ORAL 20060920 OTC MONOGRAPH FINAL part343 Nobel Laboratories, LLC ASPIRIN 81 mg/1 N 20181231 10599-003_2000a4b1-7604-4443-93bc-0a0605d8f280 10599-003 HUMAN PRESCRIPTION DRUG Sinuva mometasone furoate IMPLANT INTRASINAL 20180201 NDA NDA209310 Intersect ENT, Inc. MOMETASONE FUROATE 1350 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10613-000_64431eff-e7a4-2a22-e053-2991aa0aecf9 10613-000 HUMAN PRESCRIPTION DRUG Oxygen OXYGEN GAS RESPIRATORY (INHALATION) 20180202 ANDA ANDA206023 Hospice Management Partners, L.C. OXYGEN 1 L/L N 20191231 10631-091_f87f6e5f-30bc-4658-b7ed-7c2a823522a0 10631-091 HUMAN PRESCRIPTION DRUG Eurax crotamiton CREAM TOPICAL 20081215 NDA NDA006927 Ranbaxy Laboratories Inc. CROTAMITON 100 mg/g N 20181231 10631-092_f87f6e5f-30bc-4658-b7ed-7c2a823522a0 10631-092 HUMAN PRESCRIPTION DRUG Eurax crotamiton LOTION TOPICAL 20081113 NDA NDA009112 Ranbaxy Laboratories Inc. CROTAMITON 100 mg/g N 20181231 10631-093_7c68e69d-0fd0-4c1b-b586-530bfb075538 10631-093 HUMAN PRESCRIPTION DRUG Kenalog Triamcinolone Acetonide AEROSOL, SPRAY TOPICAL 20090519 NDA NDA012104 Sun Pharmaceutical Industries, Inc. TRIAMCINOLONE ACETONIDE .147 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10631-094_0b8a0b2b-13df-4b21-9e3b-efe594959569 10631-094 HUMAN PRESCRIPTION DRUG Halog Halcinonide Cream CREAM TOPICAL 20090210 NDA NDA017556 Sun Pharmaceutical Industries, Inc. HALCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10631-096_3f607c24-8b81-4371-b1e4-5782b94e2149 10631-096 HUMAN PRESCRIPTION DRUG HALOG HALCINONIDE OINTMENT TOPICAL 20090519 NDA NDA017824 Sun Pharmaceutical Industries, Inc. HALCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10631-098_97c531eb-d922-445b-894b-74d644d4f0aa 10631-098 HUMAN PRESCRIPTION DRUG Lac-Hydrin ammonium lactate LOTION TOPICAL 20080815 NDA NDA019155 Ranbaxy Laboratories Inc. AMMONIUM LACTATE 120 mg/g N 20181231 10631-099_807054c6-2dae-4cc2-b790-674ab66cf79b 10631-099 HUMAN PRESCRIPTION DRUG Lac Hydrin Cream ammonium lactate CREAM TOPICAL 20090316 NDA NDA020508 Ranbaxy Laboratories Inc. AMMONIUM LACTATE 120 mg/g N 20181231 10631-100_9941b19b-425c-4689-9f45-30674efc501d 10631-100 HUMAN PRESCRIPTION DRUG Exelderm sulconazole nitrate SOLUTION TOPICAL 20090408 NDA NDA018738 Sun Pharmaceutical Industries, Inc. SULCONAZOLE NITRATE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 10631-101_c3facbe9-14d5-4d1d-bd98-2f13d1ec4120 10631-101 HUMAN PRESCRIPTION DRUG Exelderm sulconazole nitrate CREAM TOPICAL 20100201 NDA NDA018737 Sun Pharmaceutical Industries, Inc. SULCONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 10631-102_cd9a3fc1-f9e4-4ab7-9c75-50ab9c65e270 10631-102 HUMAN PRESCRIPTION DRUG Ultravate halobetasol propionate OINTMENT TOPICAL 20090220 NDA NDA019968 Ranbaxy Laboratories Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10631-103_cd9a3fc1-f9e4-4ab7-9c75-50ab9c65e270 10631-103 HUMAN PRESCRIPTION DRUG Ultravate halobetasol propionate CREAM TOPICAL 20090316 NDA NDA019967 Ranbaxy Laboratories Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10631-105_baabd35a-322c-4245-9a1b-c86c83008047 10631-105 HUMAN PRESCRIPTION DRUG Westcort Hydrocortisone valerate OINTMENT TOPICAL 20081006 NDA NDA018726 Ranbaxy Laboratories Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10631-110_61f90e50-452f-22aa-e053-2a91aa0ad386 10631-110 HUMAN PRESCRIPTION DRUG Ultravate PAC halobetasol propionate OINTMENT TOPICAL 20080513 NDA NDA019968 Sun Pharmaceutical Industries, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 10631-113_61f79003-e0cb-2b7d-e053-2a91aa0a5954 10631-113 HUMAN PRESCRIPTION DRUG Ultravate PAC-Cream halobetasol propionate CREAM TOPICAL 20100210 NDA NDA019967 Sun Pharmaceutical Industries, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 10631-115_d47315a5-6415-45d7-8b17-9fcbd5267e45 10631-115 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 NDA NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 10631-116_d47315a5-6415-45d7-8b17-9fcbd5267e45 10631-116 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 NDA NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 10631-117_d47315a5-6415-45d7-8b17-9fcbd5267e45 10631-117 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 NDA NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 30 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 10631-118_d47315a5-6415-45d7-8b17-9fcbd5267e45 10631-118 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 NDA NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 10631-119_94656dc4-95ad-4d89-9acd-f7a15854127e 10631-119 HUMAN PRESCRIPTION DRUG Ultravate X Halobetasol Propionate KIT 20120701 NDA NDA019968 Ranbaxy Laboratories Inc. E 20171231 10631-121_346cc153-69ac-4e6f-802c-3ba322347598 10631-121 HUMAN PRESCRIPTION DRUG Ultravate X Halobetasol Propionate KIT 20120709 NDA NDA019967 Ranbaxy Laboratories Inc. N 20181231 10631-122_61f770e1-d685-4127-a45b-f01704b58534 10631-122 HUMAN PRESCRIPTION DRUG Ultravate halobetasol propionate LOTION TOPICAL 20160301 NDA NDA208183 Sun Pharmaceutical Industries, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10631-133_d47315a5-6415-45d7-8b17-9fcbd5267e45 10631-133 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 NDA NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 10631-134_d47315a5-6415-45d7-8b17-9fcbd5267e45 10631-134 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 NDA NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 35 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 10631-206_e3052fae-ed34-407c-a117-c7d541a12529 10631-206 HUMAN PRESCRIPTION DRUG Riomet Metformin hydrochloride SOLUTION ORAL 20040104 NDA NDA021591 Ranbaxy Laboratories Inc. METFORMIN HYDROCHLORIDE 500 mg/5mL Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 10631-238_e3052fae-ed34-407c-a117-c7d541a12529 10631-238 HUMAN PRESCRIPTION DRUG Riomet Metformin hydrochloride SOLUTION ORAL 20040104 NDA NDA021591 Ranbaxy Laboratories Inc. METFORMIN HYDROCHLORIDE 500 mg/5mL Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 10631-278_0e775c30-7294-4e99-bcc5-3b3b01a62fc5 10631-278 HUMAN OTC DRUG Desquam-X Wash benzoyl peroxide SOLUTION TOPICAL 20110426 OTC MONOGRAPH FINAL part333D Ranbaxy Laboratories Inc. BENZOYL PEROXIDE 5 mg/g N 20181231 10631-279_0e775c30-7294-4e99-bcc5-3b3b01a62fc5 10631-279 HUMAN OTC DRUG Desquam-X Wash benzoyl peroxide SOLUTION TOPICAL 20110426 OTC MONOGRAPH FINAL part333D Ranbaxy Laboratories Inc. BENZOYL PEROXIDE 10 mg/g N 20181231 10631-284_aaa9dea2-e064-494b-8a69-de5d520594a8 10631-284 HUMAN PRESCRIPTION DRUG Desquam-X wash benzoyl peroxide SOLUTION TOPICAL 20080827 UNAPPROVED DRUG OTHER Ranbaxy Laboratories Inc. BENZOYL PEROXIDE 5 mg/mL N 20181231 10631-285_aaa9dea2-e064-494b-8a69-de5d520594a8 10631-285 HUMAN PRESCRIPTION DRUG Desquam-X wash benzoyl peroxide SOLUTION TOPICAL 20080502 UNAPPROVED DRUG OTHER Ranbaxy Laboratories Inc. BENZOYL PEROXIDE 10 mg/mL N 20181231 10631-330_6e7d2a2f-e4b2-4d12-8d5d-e1c3a832b35c 10631-330 HUMAN PRESCRIPTION DRUG Ximino minocycline hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120901 NDA NDA201922 Ranbaxy Laboratories Inc. MINOCYCLINE HYDROCHLORIDE 45 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 10631-331_6e7d2a2f-e4b2-4d12-8d5d-e1c3a832b35c 10631-331 HUMAN PRESCRIPTION DRUG Ximino minocycline hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120901 NDA NDA201922 Ranbaxy Laboratories Inc. MINOCYCLINE HYDROCHLORIDE 90 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 10631-332_6e7d2a2f-e4b2-4d12-8d5d-e1c3a832b35c 10631-332 HUMAN PRESCRIPTION DRUG Ximino minocycline hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120901 NDA NDA201922 Ranbaxy Laboratories Inc. MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 10631-407_cf451708-70ab-47f1-9b44-bf0cc602e261 10631-407 HUMAN PRESCRIPTION DRUG Proctosol-HC Hydrocortisone CREAM TOPICAL 20050428 ANDA ANDA088799 Ranbaxy Laboratories Inc HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 10641-001_825a16a8-489c-4101-b99c-0f9535a51718 10641-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19530908 UNAPPROVED MEDICAL GAS Lake Welding Supply Company OXYGEN 995 mL/L E 20171231 10655-1944_78e5be58-ba81-429a-914c-882d04c4e67f 10655-1944 HUMAN OTC DRUG Nasosol Saline SODIUM CHLORIDE SPRAY NASAL 20110111 UNAPPROVED DRUG OTHER Benton Therapeutics, Inc. SODIUM CHLORIDE 3 mL/100mL E 20171231 10671-010_e927bccf-3a58-4b04-b59e-438972def701 10671-010 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205827 Air Liquide America L.P. OXYGEN 99 L/100L E 20171231 10671-011_777ed484-a0e9-4e5e-8018-bfcb406ba89d 10671-011 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205827 Air Liquide America L.P. OXYGEN 99 L/100L E 20171231 10671-013_7be08f4d-20f9-43ee-9ee4-2c9d97a8d15d 10671-013 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205827 Air Liquide America L.P. OXYGEN 99 L/100L E 20171231 10671-020_671a2489-fe65-4fdb-9219-87842d9dddd8 10671-020 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205829 Air Liquide America L.P. NITROGEN 99 L/100L E 20171231 10671-021_671a2489-fe65-4fdb-9219-87842d9dddd8 10671-021 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205829 Air Liquide America L.P. NITROGEN 99 L/100L E 20171231 10671-022_671a2489-fe65-4fdb-9219-87842d9dddd8 10671-022 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205829 Air Liquide America L.P. NITROGEN 99 L/100L E 20171231 10671-023_671a2489-fe65-4fdb-9219-87842d9dddd8 10671-023 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION) 19600101 NDA NDA205829 Air Liquide America L.P. NITROGEN 99 L/100L E 20171231 10671-100_7f446b65-78de-4138-8474-d93f14538adb 10671-100 HUMAN PRESCRIPTION DRUG EZ-OX OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205827 Air Liquide America L.P. OXYGEN 99 L/100L E 20171231 10671-101_5e617966-03e2-48f3-b2f9-b5a48087dd54 10671-101 HUMAN PRESCRIPTION DRUG EZ-OX Plus EZ-OX Plus GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205827 Air Liquide America L.P. OXYGEN 99 L/100L E 20171231 10675-002_3f08b518-8975-4eeb-aad6-49c0948fff89 10675-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS America's Healthcare At Home, Inc. OXYGEN 99 L/100L E 20171231 10678-001_87f75b7d-93c7-4f9d-b04b-12505e417a6f 10678-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. OXYGEN 992 mL/L E 20171231 10678-002_110133ca-2e25-4873-a5fe-beaa53a0d166 10678-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. NITROGEN 992 mL/L E 20171231 10678-003_a417c555-9f9a-4ba5-8b0d-87c680fc41e2 10678-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. CARBON DIOXIDE 992 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 10678-004_30a834fa-7c4e-4b5c-9035-523b42035056 10678-004 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. HELIUM 992 mL/L E 20171231 10678-005_04f969ab-32bb-4599-b58d-a03c232f2a89 10678-005 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. AIR 1000 mL/L E 20171231 10678-006_9e4d7ac2-5a05-47ee-9349-87431e028eeb 10678-006 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. NITROUS OXIDE 992 mL/L E 20171231 10678-007_1908fe5a-36f1-4ce3-a458-90154a81025c 10678-007 HUMAN PRESCRIPTION DRUG Helium Oxygen Mix Helium Oxygen Mix GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. HELIUM; OXYGEN 600; 400 mL/L; mL/L E 20171231 10678-008_27ec7dff-f916-46fe-97bd-76e007305446 10678-008 HUMAN PRESCRIPTION DRUG Oxygen Carbon Dioxide Mix Oxygen Carbon Dioxide Mix GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. OXYGEN; CARBON DIOXIDE 950; 50 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 10678-010_e8e2d396-66f6-4ff2-8601-733753b23a42 10678-010 HUMAN PRESCRIPTION DRUG Helium Oxygen Mix 70/30 Helium Oxygen Mix 70/30 GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. HELIUM; OXYGEN 700; 300 mL/L; mL/L E 20171231 10678-011_1155add9-7528-4250-9580-11c42d0c7a2e 10678-011 HUMAN PRESCRIPTION DRUG Helium Oxygen Mix 80/20 Helium Oxygen Mix 80/20 GAS RESPIRATORY (INHALATION) 19470523 UNAPPROVED MEDICAL GAS Airgas-West, Inc. HELIUM; OXYGEN 800; 200 mL/L; mL/L E 20171231 10685-511_6416b514-b61f-d547-e053-2991aa0aaf2f 10685-511 HUMAN OTC DRUG PC511 ANTIMICROBIAL CHLOROXYLENOL SOAP TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part333E CARROLL COMPANY CHLOROXYLENOL 3 g/1000mL N 20191231 10685-520_6416fa98-1653-1068-e053-2a91aa0acdca 10685-520 HUMAN OTC DRUG Clean N Fresh Instant Hand Sanitizer Alcohol SOAP TOPICAL 20001001 OTC MONOGRAPH NOT FINAL part333E Carroll Company ALCOHOL .62 mL/mL N 20191231 10685-529_6416fa98-1660-1068-e053-2a91aa0acdca 10685-529 HUMAN OTC DRUG PC529 ULTREX CHLOROXYLENOL SOAP TOPICAL 20140121 OTC MONOGRAPH NOT FINAL part333E CARROLL COMPANY CHLOROXYLENOL 2.5 g/1000mL N 20191231 10685-537_64141f12-5560-8625-e053-2991aa0a8500 10685-537 HUMAN OTC DRUG PC537 E-2 BRUTE CHLOROXYLENOL SOAP TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part333E CARROLL COMPANY CHLOROXYLENOL 25 g/1000mL N 20191231 10685-557_64141eda-46ae-8480-e053-2991aa0a9d77 10685-557 HUMAN OTC DRUG PC557 PALPON CHLOROXYLENOL SOAP TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E CARROLL COMPANY CHLOROXYLENOL 2.5 g/1000mL N 20191231 10685-681_641704f3-7e7a-73d3-e053-2991aa0af008 10685-681 HUMAN OTC DRUG Carroll Ultrex Antimicrobial Wipes Benzalkonium Chloride CLOTH TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part333E Carroll Company BENZALKONIUM CHLORIDE .01417 g/1 N 20191231 10685-682_6416fa98-1691-1068-e053-2a91aa0acdca 10685-682 HUMAN OTC DRUG Carroll Hand Sanitizer Wipes with Aloe Benzalkonium Chloride CLOTH TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part333E Carroll Company BENZALKONIUM CHLORIDE .0067275 g/1 N 20191231 10685-978_64172e49-c387-6574-e053-2a91aa0ab959 10685-978 HUMAN OTC DRUG NAMICO ANTISEPTIC HAND CLEANER 557 CHLOROXYLENOL SOAP TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E CARROLL COMPANY CHLOROXYLENOL 2.5 g/1000mL N 20191231 10690-001_333a0a64-679c-4839-908f-95e7d89b63d0 10690-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19780101 NDA NDA205865 Depke Welding Supplies, Inc. OXYGEN 995 mL/L N 20181231 10690-002_48b269b7-62d9-400e-97c3-e6a32588927b 10690-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19870101 NDA NDA205866 Depke Welding Supplies, Inc. NITROGEN 990 mL/L N 20181231 10698-0001_5c95353f-ec04-433f-a48a-b5e991d74f8c 10698-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19480101 NDA NDA205849 Mabscott Supply Company OXYGEN 99 L/100L N 20181231 10702-001_31038222-46cf-4887-b756-8b64e8526e26 10702-001 HUMAN PRESCRIPTION DRUG LOMAIRA Phentermine Hydrochloride TABLET ORAL 20160912 ANDA ANDA203495 KVK-TECH, INC. PHENTERMINE HYDROCHLORIDE 8 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 10702-002_0148e8c4-b968-4582-ad96-1f15e0a7635c 10702-002 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET ORAL 20070504 ANDA ANDA040712 KVK-Tech, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 10702-003_0148e8c4-b968-4582-ad96-1f15e0a7635c 10702-003 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET ORAL 20060731 ANDA ANDA040712 KVK-Tech, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 10702-004_0148e8c4-b968-4582-ad96-1f15e0a7635c 10702-004 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET ORAL 20060731 ANDA ANDA040712 KVK-Tech, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 10702-006_bda85150-0a9d-452b-b6f5-0fac7cf001ff 10702-006 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 KVK-TECH, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 10702-007_bda85150-0a9d-452b-b6f5-0fac7cf001ff 10702-007 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 KVK-TECH, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 10702-008_b411c0e2-351e-4aae-893e-c1e9ec384ab4 10702-008 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20090831 ANDA ANDA091393 KVK-TECH,INC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 10702-009_b411c0e2-351e-4aae-893e-c1e9ec384ab4 10702-009 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20090831 ANDA ANDA091393 KVK-TECH,INC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 10702-010_18d9ab50-01a6-492b-97b3-72eca2d93fde 10702-010 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040786 KVK-Tech, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 10702-011_18d9ab50-01a6-492b-97b3-72eca2d93fde 10702-011 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040787 KVK-Tech, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 10702-012_18d9ab50-01a6-492b-97b3-72eca2d93fde 10702-012 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040788 KVK-Tech, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 10702-013_619098b2-7515-433c-b3a9-eeef2852e781 10702-013 HUMAN PRESCRIPTION DRUG BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET, COATED ORAL 20111102 ANDA ANDA078962 KVK-TECH, INC. BETAXOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 10702-014_619098b2-7515-433c-b3a9-eeef2852e781 10702-014 HUMAN PRESCRIPTION DRUG BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET, COATED ORAL 20111102 ANDA ANDA078962 KVK-TECH, INC. BETAXOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 10702-016_020555cc-dbf9-4a88-b2a1-92a0680407ec 10702-016 HUMAN PRESCRIPTION DRUG INDOMETHACIN Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20090306 ANDA ANDA079175 KVK-Tech, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 10702-017_1e77d389-a981-41bb-9e1c-e2684cfc03b0 10702-017 HUMAN OTC DRUG Chlorphen-12 Chlorpheniramine Maleate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100615 ANDA ANDA040829 KVK-Tech, Inc. CHLORPHENIRAMINE MALEATE 12 mg/1 N 20181231 10702-018_b411c0e2-351e-4aae-893e-c1e9ec384ab4 10702-018 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20090831 ANDA ANDA091393 KVK-TECH,INC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 10702-023_fd61deb5-0a98-4f06-8ec4-968a90403df9 10702-023 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20150820 ANDA ANDA202773 KVK-TECH, INC. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 10702-025_75698438-11a0-4dc2-8028-1de81ce23a9a 10702-025 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040876 KVK-TECH, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 10702-026_651cbdb9-b528-4c14-bddf-d7f375a45f16 10702-026 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 KVK-Tech, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 10702-027_651cbdb9-b528-4c14-bddf-d7f375a45f16 10702-027 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 KVK-Tech, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 10702-028_651cbdb9-b528-4c14-bddf-d7f375a45f16 10702-028 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 KVK-Tech, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 10702-029_75698438-11a0-4dc2-8028-1de81ce23a9a 10702-029 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120815 ANDA ANDA040887 KVK-TECH, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 10702-036_e142c279-74a0-410f-9e9f-be9112822fa9 10702-036 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate POWDER ORAL; RECTAL 20090330 ANDA ANDA040905 KVK-Tech, Inc. SODIUM POLYSTYRENE SULFONATE 1 g/g N 20181231 10702-040_c84f6132-97d5-465b-8751-c6c8f167e52b 10702-040 HUMAN PRESCRIPTION DRUG BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET ORAL 20100721 ANDA ANDA090968 KVK-TECH, INC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 10702-044_5cc4380a-e00a-4dc3-b10a-e5e081863209 10702-044 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TABLET ORAL 20101227 ANDA ANDA201212 KVK-TECH, INC DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 10702-045_0001e2a9-d073-4d16-9b45-96d176ec38f4 10702-045 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 KVK-TECH, INC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 10702-055_dadadad9-47b2-4c44-b069-09fcd0903acb 10702-055 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide TABLET ORAL 20170807 ANDA ANDA207176 KVK-Tech, Inc. HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 10702-056_b411c0e2-351e-4aae-893e-c1e9ec384ab4 10702-056 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20090831 ANDA ANDA091393 KVK-TECH,INC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 10702-057_b411c0e2-351e-4aae-893e-c1e9ec384ab4 10702-057 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20090831 ANDA ANDA091393 KVK-TECH,INC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 10702-065_b7dbcda0-c626-4563-830a-de6d14f55722 10702-065 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate TABLET ORAL 20151123 ANDA ANDA203548 KVK-Tech, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 10702-066_b7dbcda0-c626-4563-830a-de6d14f55722 10702-066 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate TABLET ORAL 20151123 ANDA ANDA203548 KVK-Tech, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 10702-070_69cdb4f9-b8f5-4451-aa9b-0f1e8553067c 10702-070 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20130211 ANDA ANDA203601 KVK-Tech, Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 10702-071_69cdb4f9-b8f5-4451-aa9b-0f1e8553067c 10702-071 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20130211 ANDA ANDA203601 KVK-Tech, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 10702-075_98748e08-aeb6-4a38-b4ca-cf4cc6bf775f 10702-075 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE methylphenidate hydrochloride extended release TABLET ORAL 20150609 ANDA ANDA207488 KVK-Tech, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 10702-076_98748e08-aeb6-4a38-b4ca-cf4cc6bf775f 10702-076 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE methylphenidate hydrochloride extended release TABLET ORAL 20150609 ANDA ANDA207488 KVK-Tech, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 10702-077_0001e2a9-d073-4d16-9b45-96d176ec38f4 10702-077 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 KVK-TECH, INC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 10702-078_0001e2a9-d073-4d16-9b45-96d176ec38f4 10702-078 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 KVK-TECH, INC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 10702-100_b4bd8e32-6dfb-41e9-8243-8e17c99f5704 10702-100 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20170511 ANDA ANDA206932 KVK-TECH, INC. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 10702-101_b4bd8e32-6dfb-41e9-8243-8e17c99f5704 10702-101 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20170511 ANDA ANDA206932 KVK-TECH, INC. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 10702-102_b4bd8e32-6dfb-41e9-8243-8e17c99f5704 10702-102 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20170511 ANDA ANDA206932 KVK-TECH, INC. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 10702-106_a3338680-0e87-462b-8cdd-fc141eee3f09 10702-106 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20151204 ANDA ANDA206931 KVK-TECH, INC DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 10702-107_a3338680-0e87-462b-8cdd-fc141eee3f09 10702-107 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20151204 ANDA ANDA206931 KVK-TECH, INC DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 10702-108_a3338680-0e87-462b-8cdd-fc141eee3f09 10702-108 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20151204 ANDA ANDA206931 KVK-TECH, INC DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 10702-150_fae6f102-f619-40e6-9282-200ce2ae9742 10702-150 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide hydrocodone bitartrate and homatropine methylbromide oral solution LIQUID ORAL 20170221 ANDA ANDA207487 KVK-Tech, Inc. HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 10702-163_9b9f394b-5d51-4070-9e15-9e4db8b7449a 10702-163 HUMAN PRESCRIPTION DRUG Methylphenidate Methylphenidate Hydrochloride SOLUTION ORAL 20161121 ANDA ANDA207485 KVK-Tech, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 10702-164_9b9f394b-5d51-4070-9e15-9e4db8b7449a 10702-164 HUMAN PRESCRIPTION DRUG Methylphenidate Methylphenidate Hydrochloride SOLUTION ORAL 20161121 ANDA ANDA207485 KVK-Tech, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 10702-171_b6d52ce3-7e4f-4314-89df-9803b38c2bcf 10702-171 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION ORAL 20170721 ANDA ANDA208593 KVK-Tech, Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 10702-183_b6d52ce3-7e4f-4314-89df-9803b38c2bcf 10702-183 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20170721 ANDA ANDA208593 KVK-Tech, Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 10702-189_a3094bfe-e895-49ca-8ec5-3ed2fc4107fe 10702-189 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170622 ANDA ANDA209037 KVK-Tech, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 10702-190_a3094bfe-e895-49ca-8ec5-3ed2fc4107fe 10702-190 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170622 ANDA ANDA209037 KVK-Tech, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 10702-191_a3094bfe-e895-49ca-8ec5-3ed2fc4107fe 10702-191 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170622 ANDA ANDA209037 KVK-Tech, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 10702-192_a3094bfe-e895-49ca-8ec5-3ed2fc4107fe 10702-192 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170622 ANDA ANDA209036 KVK-Tech, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 10702-193_a3094bfe-e895-49ca-8ec5-3ed2fc4107fe 10702-193 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170622 ANDA ANDA209036 KVK-Tech, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 10702-194_a3094bfe-e895-49ca-8ec5-3ed2fc4107fe 10702-194 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20170622 ANDA ANDA209036 KVK-Tech, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 10702-201_89ac329f-7308-43cf-849d-0556ea531e2f 10702-201 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20171222 ANDA ANDA209335 KVK-Tech, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 10702-283_767105a0-65a5-444a-989f-f766b0851c2a 10702-283 HUMAN PRESCRIPTION DRUG ColPrep Kit sodium sulfate, potassium sulfate, and magnesium sulfate for oral solution POWDER, FOR SOLUTION ORAL 20161227 NDA NDA204553 KVK-Tech, Inc. SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE 17.5; 3.13; 1.6 g/22.7g; g/22.7g; g/22.7g Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 10705-077_d2a5e150-5fe4-483a-a5ca-39b58e42f95f 10705-077 HUMAN OTC DRUG Mandelay Male Genital Desensitizer Benzocaine GEL TOPICAL 19951031 OTC MONOGRAPH FINAL part348 Majestic Drug Co., INC. BENZOCAINE 2.13 g/28.35g N 20181231 10725-0001_6ce0db86-2999-4d52-be7e-1578b481794e 10725-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19730101 UNAPPROVED MEDICAL GAS Red River Welding Supply Co. dba McGinnis Welding Supply Co OXYGEN 99 L/100L E 20171231 10733-130_f025f863-bb6f-49e8-b6d9-5702e933aa29 10733-130 HUMAN PRESCRIPTION DRUG FluoriSHIELD Sodium Fluoride GEL DENTAL 20091129 UNAPPROVED DRUG OTHER Medical Products Laboratories, Inc. SODIUM FLUORIDE 11 mg/g E 20171231 10733-357_629c5273-6b0c-406f-bee8-3a6c485deabb 10733-357 HUMAN PRESCRIPTION DRUG kolorz Sodium Fluoride AEROSOL, FOAM DENTAL 20070101 UNAPPROVED DRUG OTHER Medical Products Laboratories, Inc. SODIUM FLUORIDE 27.2 mg/g E 20171231 10733-372_7d3a5132-76a6-4e74-bc5a-19607cecb30f 10733-372 HUMAN PRESCRIPTION DRUG kolorz Sodium Fluoride AEROSOL, FOAM DENTAL 20070101 UNAPPROVED DRUG OTHER Medical Products Laboratories, Inc. SODIUM FLUORIDE 27.2 mg/g E 20171231 10733-395_b7d0782a-07e2-47df-b118-57902a1eb724 10733-395 HUMAN PRESCRIPTION DRUG kolorz Sodium Fluoride AEROSOL, FOAM DENTAL 20070101 UNAPPROVED DRUG OTHER Medical Products Laboratories, Inc. SODIUM FLUORIDE 27.2 mg/g E 20171231 10733-412_13a2ec4c-8915-4875-a1ef-24395b846eda 10733-412 HUMAN PRESCRIPTION DRUG lumicain Aluminium Chloride Hexahydrate SOLUTION TOPICAL 20100929 UNAPPROVED DRUG OTHER Medical Products Laboratories, Inc. ALUMINUM CHLORIDE 250 mg/g E 20171231 10733-415_f817cb22-d121-ec6c-cdaa-a2719facf0be 10733-415 HUMAN PRESCRIPTION DRUG Salinocaine salicylic acid and benzocaine OINTMENT TOPICAL 19380601 UNAPPROVED DRUG OTHER Medical Products Laboratories, Inc. SALICYLIC ACID; BENZOCAINE 550; 20 mg/g; mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 10736-001_911a4844-03d5-4e44-9dc7-ff3c4a25c4dc 10736-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20120529 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. OXYGEN 99 L/100L N 20181231 10736-002_024d0394-d48a-4b30-a234-7ab72da78c31 10736-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20120529 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. NITROGEN 99 L/100L N 20181231 10736-009_2ef85bec-351c-4043-939b-ce6cf843e9e7 10736-009 HUMAN PRESCRIPTION DRUG COMPRESSED GAS, OXIDIZING, N.O.S. OXYGEN, CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 20120529 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. OXYGEN; CARBON DIOXIDE 95; 5 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 10736-010_3938863f-60c6-498a-82cf-7b786ee1ef81 10736-010 HUMAN PRESCRIPTION DRUG COMPRESSED GAS, OXIDIZING, N.O.S. OXYGEN, CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 20120529 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. OXYGEN; CARBON DIOXIDE 95; 5 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 10736-011_1ffa362c-7cf7-4c60-9ee0-43de0fa84b42 10736-011 HUMAN PRESCRIPTION DRUG COMPRESSED GAS N.O.S. OXYGEN, NITROGEN, CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 20120529 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. OXYGEN; NITROGEN; CARBON DIOXIDE 19.95; 75.05; 5 mL/L; mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 10736-012_8bd8ffb9-e67b-4c0e-845f-5a9df5f799e2 10736-012 HUMAN PRESCRIPTION DRUG Carbon Dioxide Air Mix Carbon Dioxide Air Mix GAS RESPIRATORY (INHALATION) 20120529 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. CARBON DIOXIDE; AIR 10; 990 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 10736-013_72aa1b23-a1e1-43e9-b02b-0a3d99221366 10736-013 HUMAN PRESCRIPTION DRUG Helium Oxygen Mixture Helium Oxygen mixture GAS RESPIRATORY (INHALATION) 20140501 UNAPPROVED MEDICAL GAS Medical-technical Gases, Inc. HELIUM; OXYGEN 800; 200 mL/L; mL/L E 20171231 10736-014_1a42ac0a-0fea-41ed-8289-0affef995c90 10736-014 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 19630101 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. CARBON DIOXIDE 995 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 10736-016_d3dee2f2-6bc1-4622-a0c3-7709f7c77f91 10736-016 HUMAN PRESCRIPTION DRUG AIR AIR GAS RESPIRATORY (INHALATION) 19630101 UNAPPROVED MEDICAL GAS Medical-Technical Gases, Inc. AIR 1000 mL/L N 20181231 10738-014_1efea4d6-e63b-4653-a194-4fcf7ecac15a 10738-014 HUMAN OTC DRUG LIGHT AND DELICATE SUNSCREEN SPF15 AVOBENZONE, BENZOPHENONE-3, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20160801 OTC MONOGRAPH FINAL part352 Genuine Virgin Aloe Corporation AVOBENZONE; OXYBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 7.49; 5; 2.7 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 10738-029_dbb69e69-461d-48e4-a317-64e0b653114f 10738-029 HUMAN OTC DRUG LIGHT AND DELICATE SUNSCREEN SPF30 AVOBENZONE, BENZOPHENONE-3, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20160802 OTC MONOGRAPH FINAL part352 Genuine Virgin Aloe Corporation AVOBENZONE; OXYBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 7.49; 5; 2.7 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 10738-101_fa3baaf8-076f-45d6-b34b-672a75bf63b3 10738-101 HUMAN OTC DRUG PSORIASIS CONTROL SALICYLIC ACID CREAM TOPICAL 20111218 OTC MONOGRAPH FINAL part358H Genuine Virgin Aloe Corporation SALICYLIC ACID 2.5 g/100g E 20171231 10738-102_7cca985b-e941-4369-9fab-7beee482f406 10738-102 HUMAN OTC DRUG ECZEMA FAST HEALING OATMEAL LOTION TOPICAL 20140103 OTC MONOGRAPH FINAL part347 Genuine Virgin Aloe Corporation OATMEAL 1.5 g/100g E 20171231 10738-201_f0c0c44e-e540-4efe-936f-af1eda17d3a0 10738-201 HUMAN OTC DRUG PAIN RELIEF LIDOCAINE AND MENTHOL CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part348 Genuine Virgin Aloe Corporation LIDOCAINE; MENTHOL 4; 1.25 g/100g; g/100g E 20171231 10738-301_13e130c1-4c6e-4cab-b55d-ec77f5afc3c4 10738-301 HUMAN OTC DRUG DIABETIC BRUISE DEFENSE ALLANTOIN CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Genuine Virgin Aloe Corporation ALLANTOIN .5 g/100g E 20171231 10738-302_e717d620-c9ab-4040-a916-344b12e238ea 10738-302 HUMAN OTC DRUG DIABETIC DRY SKIN DEFENSE ALLANTOIN AND DIMETHICONE CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Genuine Virgin Aloe Corporation ALLANTOIN; DIMETHICONE 1.5; 1.5 g/100g; g/100g E 20171231 10738-303_56dd132b-79de-4ca6-8e1f-f6645a86ecf4 10738-303 HUMAN OTC DRUG DIABETIC FOOT DEFENSE ALLANTOIN AND DIMETHICONE CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Genuine Virgin Aloe Corporation ALLANTOIN; DIMETHICONE .5; 2 g/100g; g/100g E 20171231 10738-304_52b3a32b-7f01-4aa2-83fe-19dd939db8df 10738-304 HUMAN OTC DRUG DIABETIC ULCER DEFENSE ALLANTOIN AND DIMETHICONE CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Genuine Virgin Aloe Corporation ALLANTOIN; DIMETHICONE 1.1; 1.5 g/100g; g/100g E 20171231 10742-0002_19e4b812-67c6-49fd-833a-b432100363f5 10742-0002 HUMAN OTC DRUG Mentholatum Original camphor, menthol OINTMENT TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company CAMPHOR (NATURAL); MENTHOL 90; 13 mg/g; mg/g N 20181231 10742-0009_981e5f09-891e-4775-a6ac-539fb73d51fd 10742-0009 HUMAN OTC DRUG Red Cross Toothache eugenol LIQUID TOPICAL 19830621 OTC MONOGRAPH NOT FINAL part356 The Mentholatum Company EUGENOL 850 mg/mL N 20181231 10742-1048_54bc5b4a-a051-4d12-b158-de9b8f7c8213 10742-1048 HUMAN OTC DRUG Mentholatum Natural Ice Cherry dimethicone, octinoxate, octisalate STICK TOPICAL 19990819 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE 10; 75; 50 mg/g; mg/g; mg/g N 20181231 10742-1117_0bb93658-18a8-4e6a-bfe5-56e62bc18f63 10742-1117 HUMAN OTC DRUG Cold and Hot Medicated Menthol PATCH TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL 500 mg/1 N 20181231 10742-1118_0bb93658-18a8-4e6a-bfe5-56e62bc18f63 10742-1118 HUMAN OTC DRUG Cold and Hot Medicated Menthol PATCH TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL 240 mg/1 E 20171231 10742-1233_e7b939bf-2aa4-46f8-b509-8dc2526f5ae2 10742-1233 HUMAN OTC DRUG Phisoderm Clear Confidence Face Scrub Salicylic acid GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/g N 20181231 10742-1301_cc651a15-17d6-4271-a1c1-7ed6ca4e0341 10742-1301 HUMAN OTC DRUG Oxy Rapid Spot Treatment Maximum Action benzoyl peroxide CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 100 mg/g N 20181231 10742-1306_55cb64e5-7e44-43e7-88d3-312d5e226bbc 10742-1306 HUMAN OTC DRUG Oxy Skin Clearing Blackhead Removing Scrub Daily Defense Salicylic acid GEL TOPICAL 20150101 20181030 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/g N 20191231 10742-1308_c87dc63e-583e-40bd-b07f-f05ac1341ec7 10742-1308 HUMAN OTC DRUG Oxy Rapid Treatment Face Wash Sensitive Skin Maximum Action Benzoyl Peroxide CREAM TOPICAL 20150101 20180831 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 50 mg/mL E 20171231 10742-1313_c02ff802-fe48-41fb-a9dd-6a74da334a52 10742-1313 HUMAN OTC DRUG Oxy Sensitive Face Wash Maximum Soothing Benzoyl Peroxide LOTION TOPICAL 20160801 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 50 mg/mL N 20181231 10742-1364_c5d79d04-950f-44ad-b607-dcfed851300f 10742-1364 HUMAN OTC DRUG OXY Skin Clearing 3 Way Use Cleanser Daily Defense Salicylic acid CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/g N 20181231 10742-1365_735c40be-f0ee-464f-a0b7-a22b0cb6d843 10742-1365 HUMAN OTC DRUG Oxy Rapid Treatment Face Wash Maximum Action benzoyl peroxide CREAM TOPICAL 20150101 20180630 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 100 mg/mL E 20171231 10742-1412_accafe6b-d350-4539-a39d-a9ee9a4fee29 10742-1412 HUMAN OTC DRUG Phisoderm Clear Confidence Daily Gel Face Wash Salicylic acid LIQUID TOPICAL 20120501 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/mL N 20181231 10742-1442_e4c88ea1-5311-4e1f-a9ac-facef02b9c04 10742-1442 HUMAN OTC DRUG Phisoderm Clear Confidence Body Wash Salicylic Acid LIQUID TOPICAL 20120501 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/mL N 20181231 10742-2002_d2fcc150-e64a-4598-8c34-cb34c1c641d4 10742-2002 HUMAN OTC DRUG Mentholatum Deep Heating Rub Extra Strength menthol, methyl salicylate CREAM TOPICAL 19921215 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 80; 300 mg/g; mg/g N 20181231 10742-2204_89e071f7-d832-46a9-925a-96fe16884932 10742-2204 HUMAN OTC DRUG OXY Skin Clearing Cleansing Pads Daily Defense Salicylic Acid SWAB TOPICAL 20141201 20180228 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/1 E 20171231 10742-3004_90a3894f-6012-4db8-91e6-1cdb72b1c5c9 10742-3004 HUMAN OTC DRUG Mentholatum Natural Ice Original dimethicone, octinoxate, octisalate OINTMENT TOPICAL 19990119 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE 10; 75; 50 mg/g; mg/g; mg/g N 20181231 10742-3051_1069f411-4a70-4409-905d-2ebc6b9b4ec5 10742-3051 HUMAN OTC DRUG Softlips Vanilla dimethicone, octinoxate, octisalate, oxybenzone OINTMENT TOPICAL 19971119 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g N 20181231 10742-3204_3e7583e5-7510-4ed9-b454-45924a3526b1 10742-3204 HUMAN OTC DRUG OXY Cleansing Pads Daily Defense salicylic acid SWAB TOPICAL 20160801 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/1 N 20181231 10742-3359_6548dd93-b389-4ba6-abec-e246487dcf9d 10742-3359 HUMAN OTC DRUG OXY 3 in 1 Pads Maximum Action salicylic acid SWAB TOPICAL 20160801 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/1 N 20181231 10742-8096_f4675bc1-01cc-4a33-a3bf-bfc99230fe32 10742-8096 HUMAN OTC DRUG Mentholatum No Mess Vaporizing Rub camphor, eucalyptus oil, menthol OINTMENT TOPICAL 20160701 OTC MONOGRAPH FINAL part341 The Mentholatum Company CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL, UNSPECIFIED FORM 53; 13; 28 mg/g; mg/g; mg/g N 20181231 10742-8112_49d54a73-fe4a-4230-8626-0275d81cc6f7 10742-8112 HUMAN OTC DRUG Mentholatum Nighttime Vaporizing Rub camphor, eucalyptus oil, menthol OINTMENT TOPICAL 20140714 OTC MONOGRAPH FINAL part341 The Mentholatum Company CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 48; 12; 26 mg/g; mg/g; mg/g N 20181231 10742-8123_99922a8a-7667-4666-99af-8a733d2ba565 10742-8123 HUMAN OTC DRUG WellPatch Backache Pain Relief Menthol PATCH TOPICAL 20080118 20190630 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL, UNSPECIFIED FORM 50 mg/1 N 20181231 10742-8125_13565b05-ce32-444c-8765-cda23b0036fc 10742-8125 HUMAN OTC DRUG WellPatch Cooling Pain Relief menthol PATCH TOPICAL 20170206 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company MENTHOL, UNSPECIFIED FORM 50 mg/1 N 20181231 10742-8126_da025150-6051-4471-9b7b-f5f981fd11a6 10742-8126 HUMAN OTC DRUG WellPatch Capsaicin Pain Relief Capsaicin PATCH TOPICAL 20080228 20190430 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company CAPSAICIN .25 mg/1 N 20181231 10742-8127_ec583129-55fc-4ab1-94e5-9c900b5d95ef 10742-8127 HUMAN OTC DRUG WellPatch Warming Pain Relief capsaicin PATCH TOPICAL 20161205 OTC MONOGRAPH NOT FINAL part348 The Mentholatum Company CAPSAICIN 25 mg/1 N 20181231 10742-8142_68ee0639-a88b-481f-b972-26944e07623c 10742-8142 HUMAN OTC DRUG Rohto Cool Naphazoline hydrochloride, Polysorbate 80 LIQUID OPHTHALMIC 20010821 OTC MONOGRAPH FINAL part349 The Mentholatum Company NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80 .12; 2 mg/mL; mg/mL N 20181231 10742-8143_1d8434df-49a2-4e20-8b82-6109eff12a92 10742-8143 HUMAN OTC DRUG Rohto Ice Hypromellose, Tetrahydrozoline hydrochloride, Zinc sulfate LIQUID OPHTHALMIC 20050927 OTC MONOGRAPH FINAL part349 The Mentholatum Company HYPROMELLOSES; TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE, UNSPECIFIED FORM 2; .5; 2.5 mg/mL; mg/mL; mg/mL N 20181231 10742-8145_99abceb5-c21f-49dc-9fbd-25369c5cfbf4 10742-8145 HUMAN OTC DRUG Rohto Beauty Secret Naphazoline hydrochloride, Polysorbate 80 LIQUID OPHTHALMIC 20171001 OTC MONOGRAPH FINAL part349 The Mentholatum Company NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80 .12; 2 mg/mL; mg/mL N 20181231 10742-8148_1763f71c-1d47-4399-89db-f999e207e015 10742-8148 HUMAN OTC DRUG Rohto Hydra Hydroxyethyl cellulose LIQUID OPHTHALMIC 20110103 20181031 OTC MONOGRAPH FINAL part349 The Mentholatum Company HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) 6 mg/mL N 20181231 10742-8159_7baf75cb-36a5-4a1b-8ec2-48d511d79db5 10742-8159 HUMAN OTC DRUG Rohto Cool Max Naphazoline hydrochloride, Polysorbate 80 LIQUID OPHTHALMIC 20140505 OTC MONOGRAPH FINAL part349 The Mentholatum Company NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80 .3; 2 mg/mL; mg/mL N 20181231 10742-8162_8ea5c6c9-48f4-406a-a2cb-9280c546d87d 10742-8162 HUMAN OTC DRUG Rohto Dry-Aid povidone, propylene glycol LIQUID OPHTHALMIC 20170101 OTC MONOGRAPH FINAL part349 The Mentholatum Company POVIDONES; PROPYLENE GLYCOL 6.8; 3 mg/mL; mg/mL N 20181231 10742-8177_d9652f3f-bb6e-4d74-88d6-d4dbaa3de22d 10742-8177 HUMAN OTC DRUG OXY Overnight Acne Reducing Patches salicylic acid PATCH TOPICAL 20180101 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 5 mg/1 N 20181231 10742-8189_9228d6c2-719b-4c03-8d1f-60b927fda9a3 10742-8189 HUMAN OTC DRUG Lip Relief French Vanilla white petrolatum, octinoxate, oxybenzone STICK TOPICAL 20160701 20180630 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company PETROLATUM; OCTINOXATE; OXYBENZONE 407; 75; 35 mg/g; mg/g; mg/g N 20181231 10742-8194_0dc29577-6b66-428b-a46b-546973654841 10742-8194 HUMAN OTC DRUG Rohto Jolt Hypromellose LIQUID OPHTHALMIC 20171001 OTC MONOGRAPH FINAL part349 The Mentholatum Company HYPROMELLOSE 2906 (4000 MPA.S) 3.5 mg/mL N 20181231 10742-8293_c73bbe97-2bf3-4ce3-8d4f-3a2b8c31866e 10742-8293 HUMAN OTC DRUG Phisoderm Clear Confidence Spot Treatment benzoyl peroxide CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 25 mg/g N 20181231 10742-8301_4e5e4e0d-f003-4494-b4c2-e0cc25c8ce22 10742-8301 HUMAN OTC DRUG Oxy Maximum Action Spot Treatment benzoyl peroxide CREAM TOPICAL 20130115 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 100 mg/g N 20181231 10742-8304_45fb31ac-55e5-4401-b416-9e0e83fb4d01 10742-8304 HUMAN OTC DRUG Oxy On-The-Go Acne Stick benzoyl peroxide STICK TOPICAL 20161205 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 50 mg/g N 20181231 10742-8338_eb2a0e0b-2ed5-4c14-8607-0b61ca48c495 10742-8338 HUMAN OTC DRUG OXY Volcanic Clay Acne Wash Salicylic acid CREAM TOPICAL 20180101 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/g N 20181231 10742-8353_23a90c7e-6170-4871-8bdd-6b41fc89b571 10742-8353 HUMAN OTC DRUG Oxy 10 Vanishing benzoyl peroxide LOTION TOPICAL 20150701 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 100 mg/g N 20181231 10742-8354_9d27eb99-eabd-4616-bac1-91a987763a1b 10742-8354 HUMAN OTC DRUG Oxy 10 Tinted benzoyl peroxide LOTION TOPICAL 20150701 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 100 mg/g N 20181231 10742-8355_c4aa0fff-6e4a-47a8-9adc-ac2426f8292e 10742-8355 HUMAN OTC DRUG Oxy 5 Vanishing benzoyl peroxide LOTION TOPICAL 20150701 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 50 mg/g N 20181231 10742-8356_94c863f0-711a-4807-ba1f-a56c7e3f8670 10742-8356 HUMAN OTC DRUG Oxy 5 Tinted benzoyl peroxide LOTION TOPICAL 20150701 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 50 mg/g N 20181231 10742-8397_10be40b1-99df-4ee8-8225-f8bc76135ff1 10742-8397 HUMAN OTC DRUG Oxy Face Wash Maximum Aciton benzoyl peroxide LOTION TOPICAL 20160801 OTC MONOGRAPH FINAL part333D The Mentholatum Company BENZOYL PEROXIDE 100 mg/mL N 20181231 10742-8417_9fd851bf-1113-488b-ad16-1a3ce52a87d5 10742-8417 HUMAN OTC DRUG Phisoderm Anti-Blemish Gel Cleanser Salicylic acid GEL TOPICAL 20130901 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/g N 20181231 10742-8451_bba14225-2970-4678-b5a1-78ed94c389d9 10742-8451 HUMAN OTC DRUG Phisoderm Anti Blemish Body Wash Salicylic Acid LIQUID TOPICAL 20130901 OTC MONOGRAPH FINAL part333D The Mentholatum Company SALICYLIC ACID 20 mg/mL N 20181231 10742-8470_f5f2d1ea-a0e1-4913-b1e7-edce96e41a4e 10742-8470 HUMAN OTC DRUG Softlips Raspberry dimethicone, octinoxate, octisalate, oxybenzone OINTMENT TOPICAL 20070112 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g N 20181231 10742-8476_56aaeaec-9f3a-49b7-868b-4ff262fbe811 10742-8476 HUMAN OTC DRUG Softlips Watermelon dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20120416 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; ug/g N 20181231 10742-8508_56551008-a4e0-406f-8403-980d2e6b75a0 10742-8508 HUMAN OTC DRUG Softlips Vanilla dimethicone STICK TOPICAL 20161003 OTC MONOGRAPH FINAL part347 The Mentholatum Company DIMETHICONE 20 mg/g N 20181231 10742-8510_8d55141d-5d6f-4eec-87dc-d3c808cf7a6a 10742-8510 HUMAN OTC DRUG Softlips Marshmallow Ghost dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20121001 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; ug/g N 20181231 10742-8512_7b50fd0c-3e2d-452e-92cb-71b08ee4f59c 10742-8512 HUMAN OTC DRUG Softlips Cherry dimethicone, octinoxate, octisalate, oxybenzone OINTMENT TOPICAL 20000420 OTC MONOGRAPH FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g N 20181231 10742-8517_1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb27 10742-8517 HUMAN OTC DRUG Softlips Peppermint dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20161107 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g N 20181231 10742-8563_93e1cf03-65e6-4a1f-a5bd-7848332dc983 10742-8563 HUMAN OTC DRUG Softlips Pearl octinoxate, octisalate STICK TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company OCTINOXATE; OCTISALATE 75; 50 mg/g; mg/g N 20181231 10742-8644_7675aa47-f3dd-43b2-b100-b5b079eeeef5 10742-8644 HUMAN OTC DRUG Softlips Cube Coconut Cream dimethicone, octinoxate, oxybenzone OINTMENT TOPICAL 20160901 20180916 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g N 20191231 10742-8667_af031977-7a73-4a6f-b665-080988d74df1 10742-8667 HUMAN OTC DRUG Softlips Cube Pomegranate Blueberry dimethicone, octinoxate, oxybenzone OINTMENT TOPICAL 20140224 20190303 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g N 20191231 10742-8668_7da0f6c0-b73a-4135-8fc9-e27a84d3e847 10742-8668 HUMAN OTC DRUG Softlips Cube Vanilla Bean dimethicone, octinoxate, oxybenzone OINTMENT TOPICAL 20140224 20181020 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g N 20191231 10742-8682_27cec66d-87e7-44ae-8ea0-fc73187a9f0e 10742-8682 HUMAN OTC DRUG Softlips Cube Strawberry dimethicone, octinoxate, oxybenzone OINTMENT TOPICAL 20140901 20181123 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g N 20191231 10742-8684_5bbebd21-7a2b-4666-b70f-42f755f2e468 10742-8684 HUMAN OTC DRUG Softlips Cube Peach Mango dimethicone, octinoxate, oxybenzone OINTMENT TOPICAL 20150401 20180309 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g N 20191231 10742-8692_66259a2a-6770-49f2-a29f-04b200a59a7e 10742-8692 HUMAN OTC DRUG Softlips Cube Chocolate Mint dimethicone, octinoxate, oxybenzone OINTMENT TOPICAL 20161101 20180912 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OXYBENZONE 20; 75; 30 mg/g; mg/g; mg/g N 20191231 10742-8731_de01225a-eabb-4972-bf3a-3e5a0e44abef 10742-8731 HUMAN OTC DRUG Mentholatum Cherry Vaporizing Rub camphor, eucalyptus oil, menthol OINTMENT TOPICAL 20150216 OTC MONOGRAPH FINAL part341 The Mentholatum Company CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 47; 12; 26 mg/g; mg/g; mg/g N 20181231 10742-8865_f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1 10742-8865 HUMAN OTC DRUG Mentholatum Medicated Lip Balm Original dimethicone, octinoxate, octisalate OINTMENT TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE 10; 75; 50 mg/g; mg/g; mg/g N 20181231 10742-8893_6edb132d-bb67-4e6c-8e18-db0305073a71 10742-8893 HUMAN OTC DRUG Mentholatum Medicated Lip Balm Cherry dimethicone, octinoxate, octisalate OINTMENT TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company DIMETHICONE; OCTINOXATE; OCTISALATE 10; 75; 50 mg/g; mg/g; mg/g N 20181231 10742-8902_80c28626-9ecd-4840-bf66-fbdd120391f4 10742-8902 HUMAN OTC DRUG Red Cross Oral Pain Relief benzocaine LIQUID TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part356 The Mentholatum Company BENZOCAINE 200 mg/mL N 20181231 10742-8915_54cfff96-6665-4b36-a15d-10bf6cf3a1f9 10742-8915 HUMAN OTC DRUG Red Cross Canker Sore benzocaine OINTMENT TOPICAL 19980819 OTC MONOGRAPH NOT FINAL part356 The Mentholatum Company BENZOCAINE 200 mg/g N 20181231 10742-8980_86460b38-2863-4870-a1ae-7abb554af586 10742-8980 HUMAN OTC DRUG Mentholatum Natural Ice Sport SPF 30 avobenzone, dimethicone, octinoxate, octisalate OINTMENT TOPICAL 20000329 OTC MONOGRAPH NOT FINAL part352 The Mentholatum Company AVOBENZONE; DIMETHICONE; OCTINOXATE; OCTISALATE 30; 10; 75; 50 mg/g; mg/g; mg/g; mg/g N 20181231 10755-006_17ac1766-5878-4589-8483-b0bbade82e3b 10755-006 HUMAN OTC DRUG islander spf6 Octinoxate, Octisalate, Avobenzone, Octocrylene LOTION TOPICAL 20090801 OTC MONOGRAPH FINAL part352 Island Company Lifestyle Products, LLC OCTINOXATE; OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE 50; 30; 20; 20; 15 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10755-015_214866e1-4170-48cb-b415-32edfb50bdd8 10755-015 HUMAN OTC DRUG traveler spf15 Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene LOTION TOPICAL 20090801 OTC MONOGRAPH FINAL part352 Island Company Lifestyle Products, LLC OCTINOXATE; OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE 50; 30; 20; 20; 15 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10755-030_22787fc1-a5d6-49f5-b18c-3b660349922f 10755-030 HUMAN OTC DRUG tourist spf30 Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene LOTION TOPICAL 20090801 OTC MONOGRAPH FINAL part352 Island Company Lifestyle Products, LLC OCTINOXATE; OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE 75; 50; 20; 50; 15 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10802-1202_6ac058ea-d4f4-4fcd-83e1-5f2adb8652e6 10802-1202 HUMAN PRESCRIPTION DRUG Ergomar Ergotamine Tartrate TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20120831 ANDA ANDA087693 Rosedale Therapeutics ERGOTAMINE TARTRATE 2 mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient] N 20181231 10802-8081_6f145cf1-e5d4-4f73-b40e-b7e6ef78456c 10802-8081 HUMAN OTC DRUG Derma CIDOL 2000 Chloroxylenol LIQUID TOPICAL 20150218 OTC MONOGRAPH NOT FINAL part333A Rosedale Therapeutics, LLC CHLOROXYLENOL .5 g/100mL E 20171231 10802-8082_bbd67a43-d0e6-418e-8b8d-8abf8f021f60 10802-8082 HUMAN OTC DRUG Derma Stat Ethyl alcohol AEROSOL, FOAM TOPICAL 20150216 OTC MONOGRAPH NOT FINAL part333A Rosedale Therapeutics, LLC ALCOHOL 65 mL/100mL E 20171231 10812-002_2ec3e819-1d10-47b0-83ac-17222dbb92aa 10812-002 HUMAN OTC DRUG Neutrogena Deep Moisture Day with Sunscreen Broad Spectrum SPF20 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20130501 20180601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/g; mg/g; mg/g; mg/g N 20181231 10812-007_6aaae454-6c8b-41b2-a456-42455775b4b1 10812-007 HUMAN OTC DRUG Neutrogena Healthy Defense SPF50 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20130625 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 50; 30 mg/mL; mg/mL N 20181231 10812-008_2670618d-0e8a-4738-b15f-9351a994783b 10812-008 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Fresh Plum 60 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101201 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g N 20181231 10812-009_c8d805e3-8aae-42c7-91c7-ec02c647bb4f 10812-009 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Sheer Shimmer 10 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101201 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g N 20181231 10812-010_867dd051-6450-4ff5-8b2f-de61ed634b59 10812-010 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Soft Caramel 50 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101201 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g N 20181231 10812-011_6d612490-9cca-4ff5-99b6-0f53db510e68 10812-011 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Healthy Blush 20 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101201 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g N 20181231 10812-012_aaebc088-f8ae-4a3a-b93e-a6ab7781e480 10812-012 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Sunny Berry 30 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101201 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g N 20181231 10812-013_4b6af9b7-f5e1-4ec0-ba16-a634e356f707 10812-013 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Petal Glow 40 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101201 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g N 20181231 10812-014_51fa3711-af7f-4bd0-971e-6701bf4b9189 10812-014 HUMAN OTC DRUG Neutrogena Naturals Acne Foaming Scrub Salicylic Acid LOTION TOPICAL 20121101 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 10 mg/mL N 20181231 10812-024_a49de6ff-a4e0-4eea-ba16-4d9befe431ff 10812-024 HUMAN OTC DRUG Neutrogena Naturals Acne Spot Treatment Salicylic Acid LOTION TOPICAL 20121101 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 10 mg/mL N 20181231 10812-034_c969a41c-2e80-47d9-b6da-9aa47278b6af 10812-034 HUMAN OTC DRUG Neutrogena naturals Acne Cleanser Salicylic Acid LOTION TOPICAL 20121101 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 10 mg/mL N 20181231 10812-036_318e593a-e4f9-483f-bd2b-a32ec40ad44c 10812-036 HUMAN OTC DRUG Neutrogena All-in-1 Acne Control Facial Treatment Salicylic Acid CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 1 mg/g N 20181231 10812-039_5e5ae02b-6ddd-47e6-a87c-6bf1fbe7bf20 10812-039 HUMAN OTC DRUG Neutrogena TGel Therapeutic Conditioner Salicylic Acid GEL TOPICAL 20090601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-041_a0bfc54b-c65b-4c1a-81c1-eb1bfda3f155 10812-041 HUMAN OTC DRUG Neutrogena Body Clear Body Salicylic Acid SPRAY TOPICAL 20120807 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-042_05926033-0961-4628-a1c8-9caff3b9c353 10812-042 HUMAN OTC DRUG Neutrogena Spectrum Plus Face Advanced Oil Free Sunscreen Broad Spectrum SPF100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-043_903aa365-0e25-4dea-9e5b-1c2711b2e74d 10812-043 HUMAN OTC DRUG Neutrogena Spectrum Plus Advanced Sunscreen Broad Spectrum SPF100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-050_4e207b2b-c69c-4f11-9100-85a68ad683ad 10812-050 HUMAN OTC DRUG Neutrogena Age Shield Face Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-068_a8181fa1-f5c4-46a1-9555-cb215a72a318 10812-068 HUMAN OTC DRUG Neutrogena Clear Pore Acne Treatment Benzoyl Peroxide CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part333D Neutrogena Corporation BENZOYL PEROXIDE 50 mg/g N 20181231 10812-091_0297e706-79c7-45f3-aca2-c9b044c9d7a7 10812-091 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF 55 Classic Ivory 10 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 20180901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-092_0297e706-79c7-45f3-aca2-c9b044c9d7a7 10812-092 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF55 Natural Ivory 20 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 20180901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-093_0297e706-79c7-45f3-aca2-c9b044c9d7a7 10812-093 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF 55 Buff 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 20180901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-094_0297e706-79c7-45f3-aca2-c9b044c9d7a7 10812-094 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF Nude 40 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 20180901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-095_0297e706-79c7-45f3-aca2-c9b044c9d7a7 10812-095 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF55 Soft Beige 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 20180901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-096_0297e706-79c7-45f3-aca2-c9b044c9d7a7 10812-096 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF 55 Natural Beige 60 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 20180901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-097_0297e706-79c7-45f3-aca2-c9b044c9d7a7 10812-097 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF55 Fresh Beige 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 20180901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-098_0297e706-79c7-45f3-aca2-c9b044c9d7a7 10812-098 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup SPF 55 Warm Beige 90 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101206 20180901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-106_5db2ea21-9721-4676-928e-d3d5aa5edb78 10812-106 HUMAN OTC DRUG Neutrogena Oil-Free Moisture Sunscreen Broad Spectrum SPF 35 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100601 20181002 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 23.5; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-128_c829450d-fa1a-4162-b675-bc6100bd3f23 10812-128 HUMAN OTC DRUG Neutrogena Rapid Clear 2 in 1 Fight and Fade Toner Salicylic Acid SOLUTION TOPICAL 20100325 20180802 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-129_d2944aff-4d90-4bfa-adc7-dcdff7c92461 10812-129 HUMAN OTC DRUG Neutrogena Blackhead Eliminating Daily Scrub Salicylic Acid LIQUID TOPICAL 20120320 20180601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-130_a8ae89bc-7385-4b61-996f-a153e1259954 10812-130 HUMAN OTC DRUG Neutrogena Clinical Lifting Wrinkle Treatment System Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20100415 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-132_11cb07cd-4cb0-4579-9bd5-d5e89f83a02c 10812-132 HUMAN OTC DRUG Neutrogena Men Triple Protect Face Broad Spectrum SPF20 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20151113 20180801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-152_3c944d47-9654-45a8-8498-8dc20049a9dd 10812-152 HUMAN OTC DRUG Neutrogena Tgel Daily Control 2 in 1 Pyrithione Zinc SHAMPOO TOPICAL 20110221 OTC MONOGRAPH FINAL part358H Neutrogena Corporation PYRITHIONE ZINC 10 mg/mL N 20181231 10812-153_6f974b91-a55a-47cd-9fbc-cd4d6b2d276e 10812-153 HUMAN OTC DRUG Neutrogena Rapid Clear Acne Defense Face Salicylic Acid LOTION TOPICAL 20120330 20180301 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-166_9c1962cd-5c41-4c20-a940-0ac9c58c86a1 10812-166 HUMAN OTC DRUG Neutrogena Healthy Skin Enhancer Sunscreen Broad Spectrum SPF20 - Fair to Light 20 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 51 mg/mL; mg/mL; mg/mL N 20181231 10812-167_9c1962cd-5c41-4c20-a940-0ac9c58c86a1 10812-167 HUMAN OTC DRUG Neutrogena Healthy Skin Enhancer Sunscreen Broad Spectrum SPF20 - Ivory to Fair 10 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 51 mg/mL; mg/mL; mg/mL N 20181231 10812-168_9c1962cd-5c41-4c20-a940-0ac9c58c86a1 10812-168 HUMAN OTC DRUG Neutrogena Healthy Skin Enhancer Sunscreen Broad Spectrum SPF20 - Light to Neutral 30 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 51 mg/mL; mg/mL; mg/mL N 20181231 10812-169_9c1962cd-5c41-4c20-a940-0ac9c58c86a1 10812-169 HUMAN OTC DRUG Neutrogena Healthy Skin Enhancer Sunscreen Broad Spectrum SPF20 - Tan to Medium 50 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 51 mg/mL; mg/mL; mg/mL N 20181231 10812-170_9c1962cd-5c41-4c20-a940-0ac9c58c86a1 10812-170 HUMAN OTC DRUG Neutrogena Healthy Skin Enhancer Sunscreen Broad Spectrum SPF20 - Medium to Olive 60 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 51 mg/mL; mg/mL; mg/mL N 20181231 10812-171_9c1962cd-5c41-4c20-a940-0ac9c58c86a1 10812-171 HUMAN OTC DRUG Neutrogena Healthy Skin Enhancer Sunscreen Broad Spectrum SPF20 - Neutral to Tan 40 Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 70; 30; 51 mg/mL; mg/mL; mg/mL N 20181231 10812-173_2bb78c85-7af4-4f64-844a-4ea29aee2976 10812-173 HUMAN OTC DRUG Neutrogena Clinical Lifting Wrinkle Treatment System Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20100415 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-188_b70f7a65-912a-4727-83af-c2a19ac3d3df 10812-188 HUMAN OTC DRUG Neutrogena Visibly Even Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130618 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-192_fda6cc0a-f744-49db-8a5a-94856479cf7c 10812-192 HUMAN OTC DRUG Neutrogena Fresh Cooling Sunscreen Body Mist Broad Spectrum SPF45 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20121018 20180805 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 23.5; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-198_15977785-a2b5-4b29-93a8-20e81ee3cfbf 10812-198 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Gleam 40 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g N 20181231 10812-201_15977785-a2b5-4b29-93a8-20e81ee3cfbf 10812-201 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Shine 30 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g N 20181231 10812-202_15977785-a2b5-4b29-93a8-20e81ee3cfbf 10812-202 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Glaze 60 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g N 20181231 10812-204_17f5c5e8-dc6c-4617-965a-ba1e0518f50b 10812-204 HUMAN OTC DRUG Neutrogena Rapid Clear Salicylic Acid SWAB TOPICAL 20100209 OTC MONOGRAPH FINAL part333 Neutrogena Corporation SALICYLIC ACID 20 mg/1 N 20181231 10812-205_4a321701-5263-4368-8ad1-ac4f75e24eee 10812-205 HUMAN OTC DRUG Neutrogena Oil-Free Acne Wash Daily Scrub Salicylic acid SUSPENSION TOPICAL 20110315 20180601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-208_3e47cce3-41fb-4cf5-bd7e-f966d2ae2fe2 10812-208 HUMAN OTC DRUG Neutrogena Men Age Fighter Moisturizer Sunscreen SPF15 Ensulizole and Octinoxate CREAM TOPICAL 20121113 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation ENSULIZOLE; OCTINOXATE 10; 60 mg/g; mg/g N 20181231 10812-209_c41dde88-c76e-48b0-9fb0-4d48354e182e 10812-209 HUMAN OTC DRUG Neutrogena Men Age Fighter Face Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20140901 20180601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 15; 50; 30; 40 mg/g; mg/g; mg/g; mg/g N 20181231 10812-227_730d943c-3107-44ac-8135-18d3b21bde10 10812-227 HUMAN OTC DRUG Neutrogena Healthy Skin 3 in 1 Concealer for Eyes Sunscreen Broad Spectrum SPF20 - Medium Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 95 mg/g N 20181231 10812-228_730d943c-3107-44ac-8135-18d3b21bde10 10812-228 HUMAN OTC DRUG Neutrogena Healthy Skin 3 in 1 Concealer for Eyes Sunscreen Broad Spectrum SPF20 - Light Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 95 mg/g N 20181231 10812-229_730d943c-3107-44ac-8135-18d3b21bde10 10812-229 HUMAN OTC DRUG Neutrogena Healthy Skin 3 in 1 Concealer for Eyes Sunscreen Broad Spectrum SPF20 - Fair Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 95 mg/g N 20181231 10812-234_16c3cbce-07db-4dd2-8754-16ad882a60ce 10812-234 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control Power Clear Scrub Salicylic Acid SOLUTION TOPICAL 20110615 20180718 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-236_1e4ef72d-f8d5-46b7-b0fb-812a073be6db 10812-236 HUMAN OTC DRUG Neutrogena Healthy Skin Glow Sheers Illuminating Tinted Moisturizer - Ivory to Fair 10 Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LIQUID TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 75; 50; 40; 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-237_1e4ef72d-f8d5-46b7-b0fb-812a073be6db 10812-237 HUMAN OTC DRUG Neutrogena Healthy Skin Glow Sheers Illuminating Tinted Moisturizer - Fair to Light 20 Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LIQUID TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 75; 50; 40; 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-238_1e4ef72d-f8d5-46b7-b0fb-812a073be6db 10812-238 HUMAN OTC DRUG Neutrogena Healthy Skin Glow Sheers Illuminating Tinted Moisturizer - Light to Medium 30 Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LIQUID TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 75; 50; 40; 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-239_1e4ef72d-f8d5-46b7-b0fb-812a073be6db 10812-239 HUMAN OTC DRUG Neutrogena Healthy Skin Glow Sheers Illuminating Tinted Moisturizer - Medium to Tan 40 Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LIQUID TOPICAL 20130523 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 75; 50; 40; 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-248_997530e0-94d8-4fc4-88c0-3efa3ffafa5b 10812-248 HUMAN OTC DRUG Neutrogena Day Activating SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100401 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-259_ce6eca8b-8ccc-484d-97d4-d4be7826101b 10812-259 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20070211 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 23.5; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-262_5c10ebc8-ecf2-49d6-b071-bd06b090de06 10812-262 HUMAN OTC DRUG Neutrogena Fresh Cooling Sunscreen Body Mist Broad Spectrum SPF70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20121018 20181011 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-265_10305002-7573-4577-b446-537701af8e40 10812-265 HUMAN OTC DRUG Neutrogena Age Shield Anti Oxidant Face Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121019 20180803 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-268_9de4f4aa-fa22-4f9a-aa81-330b1c7f9830 10812-268 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control Salicylic Acid CREAM TOPICAL 20110418 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-270_05fca906-d1c1-4fce-8ecf-901dac6a2545 10812-270 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20071005 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-283_902ad0f6-7b2c-4fcb-92c9-2aad272ecf92 10812-283 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF85 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 45; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-285_7f1afa44-d3f4-4499-82cf-7cde7277177f 10812-285 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control Triple Action Toner Salicylic Acid LIQUID TOPICAL 20080501 20180601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-286_13f5f65e-b137-4077-ace5-54ca308d9c80 10812-286 HUMAN OTC DRUG Neutrogena Rapid Clear 2 in 1 Fight and Fade Salicylic Acid LOTION TOPICAL 20111223 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL N 20181231 10812-287_55155328-ba53-4e58-a43e-6e1c2ea309b2 10812-287 HUMAN OTC DRUG Neutrogena Rapid Clear 7 Day Acne Intervention Salicylic Acid KIT 20091215 OTC MONOGRAPH FINAL part333 Neutrogena Corporation N 20181231 10812-292_15977785-a2b5-4b29-93a8-20e81ee3cfbf 10812-292 HUMAN OTC DRUG Neutrogena MoistureShine Lip Soother Sunscreen SPF20 - Glow 70 Octinoxate and Oxybenzone GEL TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 20 mg/g; mg/g N 20181231 10812-300_4445b74f-fc3a-4b37-9624-266c40674985 10812-300 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Pink Grapefruit Facial Cleanser Salicylic Acid LIQUID TOPICAL 20120329 20180701 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-304_730d943c-3107-44ac-8135-18d3b21bde10 10812-304 HUMAN OTC DRUG Neutrogena Healthy Skin 3 in 1 Concealer for Eyes Sunscreen Broad Spectrum SPF20 - Buff Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 95 mg/g N 20181231 10812-324_1bd63e60-21a2-4a57-9a16-d2c43ae0e4a2 10812-324 HUMAN OTC DRUG Neutrogena Pure and Free Baby Sunscreen Broad Spectrum SPF60 Plus Titanium Dioxide and Zinc Oxide STICK TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 60; 47 mg/g; mg/g N 20181231 10812-326_c3b4de18-c72f-483b-98d9-93de709034b1 10812-326 HUMAN OTC DRUG Neutrogena Ageless Intensive Anti-Wrinkle Instant Radiance Daily Moisturizer SPF25 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100610 OTC MONOGRAPH FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-331_7c6132b6-c91c-471f-8593-128dac981c73 10812-331 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Angels Blush 100 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-332_7c6132b6-c91c-471f-8593-128dac981c73 10812-332 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Think Pink 110 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; ug/g; mg/g N 20181231 10812-333_7c6132b6-c91c-471f-8593-128dac981c73 10812-333 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Tickled Pink 120 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-334_7c6132b6-c91c-471f-8593-128dac981c73 10812-334 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Anything Rose 200 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-335_7c6132b6-c91c-471f-8593-128dac981c73 10812-335 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Just Whisper 210 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-336_7c6132b6-c91c-471f-8593-128dac981c73 10812-336 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Sheer Luck 220 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-337_7c6132b6-c91c-471f-8593-128dac981c73 10812-337 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Caramel Kiss 230 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-338_7c6132b6-c91c-471f-8593-128dac981c73 10812-338 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Nude Blush 240 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-339_7c6132b6-c91c-471f-8593-128dac981c73 10812-339 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Rum Raisin 250 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-340_7c6132b6-c91c-471f-8593-128dac981c73 10812-340 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Pinch of Cinn 260 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-341_7c6132b6-c91c-471f-8593-128dac981c73 10812-341 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Mauve On 300 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-342_7c6132b6-c91c-471f-8593-128dac981c73 10812-342 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Playful Plum 310 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-343_7c6132b6-c91c-471f-8593-128dac981c73 10812-343 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Plum Paradise 320 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-344_7c6132b6-c91c-471f-8593-128dac981c73 10812-344 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Berry Burst 400 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-345_7c6132b6-c91c-471f-8593-128dac981c73 10812-345 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Cherry Twist 410 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-346_7c6132b6-c91c-471f-8593-128dac981c73 10812-346 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Poppy Red 420 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-347_7c6132b6-c91c-471f-8593-128dac981c73 10812-347 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Pomegranite 430 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-348_7c6132b6-c91c-471f-8593-128dac981c73 10812-348 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Electric Currant 440 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-349_7c6132b6-c91c-471f-8593-128dac981c73 10812-349 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Coral Dream 500 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-350_7c6132b6-c91c-471f-8593-128dac981c73 10812-350 HUMAN OTC DRUG Neutrogena MoistureShine SPF20 Peach-A-Boo 510 Octinoxate, Octisalate, and Titanium Dioxide LIPSTICK TOPICAL 20100215 OTC MONOGRAPH FINAL part352 Neutrogena Corporation OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 25; 11 mg/g; mg/g; mg/g N 20181231 10812-351_78c46582-5596-470b-b707-f5d916b06197 10812-351 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Classic Ivory 10 Salicylic Acid LIQUID TOPICAL 20100325 20180307 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-352_78c46582-5596-470b-b707-f5d916b06197 10812-352 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Natural Ivory 20 Salicylic Acid LIQUID TOPICAL 20100325 20180307 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-354_78c46582-5596-470b-b707-f5d916b06197 10812-354 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Nude 40 Salicylic Acid LIQUID TOPICAL 20100325 20180307 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-355_78c46582-5596-470b-b707-f5d916b06197 10812-355 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Soft Beige 50 Salicylic Acid LIQUID TOPICAL 20100325 20180307 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-356_78c46582-5596-470b-b707-f5d916b06197 10812-356 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Fresh Beige 70 Salicylic Acid LIQUID TOPICAL 20100325 20180307 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL E 20171231 10812-357_78c46582-5596-470b-b707-f5d916b06197 10812-357 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Medium Beige 80 Salicylic Acid LIQUID TOPICAL 20100325 20180307 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-358_78c46582-5596-470b-b707-f5d916b06197 10812-358 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Warm Beige 90 Salicylic Acid LIQUID TOPICAL 20100325 20180307 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-359_78c46582-5596-470b-b707-f5d916b06197 10812-359 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Natural Tan 100 Salicylic Acid LIQUID TOPICAL 20100325 20180307 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-360_78c46582-5596-470b-b707-f5d916b06197 10812-360 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Tan 120 Salicylic Acid LIQUID TOPICAL 20100325 20180307 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-361_78c46582-5596-470b-b707-f5d916b06197 10812-361 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Natural Beige 60 Salicylic Acid LIQUID TOPICAL 20100325 20180307 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-362_78c46582-5596-470b-b707-f5d916b06197 10812-362 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Honey Beige 110 Salicylic Acid LIQUID TOPICAL 20100325 20180307 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-365_78c46582-5596-470b-b707-f5d916b06197 10812-365 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Buff 30 Salicylic Acid LIQUID TOPICAL 20100325 20180307 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-366_fd5b5389-5589-4bd2-a3c9-630e0f5f6d34 10812-366 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-367_cabbdca9-d389-417f-8d2e-9f297ee7b84f 10812-367 HUMAN OTC DRUG Neutrogena Men Sensitive Skin Oil Free Moisture Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121015 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-379_64e5a957-bc55-450b-9933-41191529b238 10812-379 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Pink Grapefruit Cleanser Salicylic Acid LOTION TOPICAL 20110401 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-380_bf428d93-d521-4920-96dc-b4eef5070ab3 10812-380 HUMAN OTC DRUG Neutrogena Rapid Tone Repair Sunscreen SPF30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120515 20180401 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-390_5ab72859-11b9-4561-9397-0343f8d858c9 10812-390 HUMAN OTC DRUG Neutrogena Blackhead Eliminating Cleanser Mask Salicylic Acid LOTION TOPICAL 20111001 20180601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-392_56518fbd-1bef-4036-b7bf-862c784d2c44 10812-392 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20090911 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-398_fea37ec8-de21-4c0e-9e3a-c8d6c1fe735d 10812-398 HUMAN OTC DRUG Neutrogena All in 1 Acne Control Daily Scrub Salicylic Acid LIQUID TOPICAL 20111130 20180601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-415_946215d4-9f0c-4366-a31c-a2ca8fa6f52b 10812-415 HUMAN OTC DRUG Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120605 20190215 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-416_480796b8-1870-4e9e-b4d1-07f1056e291e 10812-416 HUMAN OTC DRUG Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 45; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-417_c4bb7c60-24b1-46ea-95b8-6535b4b59a5d 10812-417 HUMAN OTC DRUG Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120601 20190215 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 30; 40; 20; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-418_bce93f7f-6298-4b80-aa5c-8f5de85ea024 10812-418 HUMAN OTC DRUG Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27; 80; 50; 35; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-419_4e5c3e95-7ac2-4fd3-a4fe-62956b52405f 10812-419 HUMAN OTC DRUG Neutrogena Ultra sheer Face and Body Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 20130905 20181026 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 30 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-420_47ddb5cd-9d9f-4699-b332-2255f1d5d70e 10812-420 HUMAN OTC DRUG Neutrogena Pure and Free Baby Faces Ultra Gentle Sunscreen Broad Spectrum SPF45 Plus Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 51; 29 mg/mL; mg/mL N 20181231 10812-422_edfa4538-2d23-44ec-bcd2-60f4c2507d4e 10812-422 HUMAN OTC DRUG Neutrogena Healthy Skin Firming Sunscreen Broad Spectrum SPF15 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120702 20180701 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-423_e295a00d-53da-48d8-b13e-2ff2118bf81a 10812-423 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-424_20cc1598-10ea-49c2-8dfc-1abca1552a24 10812-424 HUMAN OTC DRUG Neutrogena Healthy Skin Radiance Sunscreen Broad Spectrum SPF15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20120802 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL N 20181231 10812-425_fb846e3e-b31c-4403-ba6d-bf50862f256d 10812-425 HUMAN OTC DRUG Neurogena Healthy Defense Moisturizer Sunscreen Broad Spectrum SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120828 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-426_b5408469-39ec-45d2-bb0e-336780e6c818 10812-426 HUMAN OTC DRUG Neutrogena Ageless Intensives Anti Wrinkle Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF20 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20070201 20180701 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 70; 40; 15; 20 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-427_890b8ff9-5400-4430-a1bf-517227ad8466 10812-427 HUMAN OTC DRUG Neutrogena Age Shield Face Oil Free Sunscreen Broad Spectrum SPF110 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121016 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-428_f7445a3a-6669-4f58-84df-7bddecfcee86 10812-428 HUMAN OTC DRUG Neutrogena Clear Face Break Out Free Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121019 20180801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25; 50; 40; 30; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-429_06103981-c599-417f-aca8-149352e13576 10812-429 HUMAN OTC DRUG Neutrogena Clear Face Break Out Free Sunscreen Broad Spectrum SPF55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121019 20180801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27; 40; 45; 60; 45 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-430_2dae76eb-d88c-46bd-b4f9-6e00eeeee431 10812-430 HUMAN OTC DRUG Neutrogena Pure and Free Sunscreen Broad Spectrum SPF50 Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20121016 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 50; 30 mg/mL; mg/mL N 20181231 10812-431_378f7653-de78-48cb-8579-070f4b7ffa21 10812-431 HUMAN OTC DRUG Neutrogena Pure and Free Baby Sunscreen Broad Spectrum SPF60 Plus Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE; ZINC OXIDE 49; 47 mg/mL; mg/mL N 20181231 10812-432_f10d2b7e-bcbb-4972-93a4-533694ce7402 10812-432 HUMAN OTC DRUG Neutrogena Spectrum Plus Advanced Sunscreen Broad Spectrum SPF100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-433_8999da2f-9700-4361-ab4f-13eaa82599f5 10812-433 HUMAN OTC DRUG Neutrogena Sport Face Oil Free Sunscreen Broad Spectrum SPF70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20081101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-434_09beaa1d-2b28-4e31-88b4-e4f0b83f06fd 10812-434 HUMAN OTC DRUG Neutrogena Sensitive Skin Sunscreen Broad Spectrum SPF60 Plus Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE; ZINC OXIDE 49; 47 mg/mL; mg/mL N 20181231 10812-435_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-435 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Classic Ivory10 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL N 20181231 10812-436_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-436 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Natural Ivory20 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL N 20181231 10812-437_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-437 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Buff30 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL N 20181231 10812-438_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-438 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Nude40 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL N 20181231 10812-439_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-439 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Soft Beige50 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL N 20181231 10812-440_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-440 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Natural Beige60 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL N 20181231 10812-441_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-441 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Fresh Beige70 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL N 20181231 10812-442_e1329ece-96a7-43fb-923b-5c988b4a66a8 10812-442 HUMAN OTC DRUG Neutrogena Nourishing Long Wear Makeup Tone Correcting Complex Sunscreen Broad Spectrum SPF20 Warm Beige80 Titanium Dioxide LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 29 mg/mL N 20181231 10812-443_a7d97a45-cda4-40df-a70c-c9b8e9bb8a27 10812-443 HUMAN OTC DRUG Neutrogena Pure and Free Baby Sunscreen Broad Spectrum SPF60 Plus Titanium Dioxide and Zinc Oxide STICK TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE; ZINC OXIDE 80; 68 mg/g; mg/g N 20181231 10812-445_7a26abea-d001-43d0-b1db-65e013b63ceb 10812-445 HUMAN OTC DRUG Neutrogena Beach Defense Sunscreen Broad Spectrum SPF50 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 20130913 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 30 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-448_b6e907b4-9396-4937-996e-bbfff1a6abf4 10812-448 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-449_1cbd5c13-159e-4221-b6f8-005a29a38415 10812-449 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-450_d9953aa6-9af4-4d5a-90aa-5888b6792bc6 10812-450 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20141201 20180310 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-451_b45d2013-3760-4656-9f96-8f2533a813ab 10812-451 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20141201 20180301 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-452_d4cf898f-7970-4d04-8e33-f0ce7e643e53 10812-452 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27; 90; 45; 80; 45 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-456_a7d64f38-bb2d-44ea-91bf-4edae6a0b4be 10812-456 HUMAN OTC DRUG Neutrogena Healthy Skin Brightening Eye Perfector Sunscreen Broad Spectrum SPF25 - Fair 05 Titanium Dioxide CREAM TOPICAL 20130524 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 18.8 mg/g N 20181231 10812-457_a7d64f38-bb2d-44ea-91bf-4edae6a0b4be 10812-457 HUMAN OTC DRUG Neutrogena Healthy Skin Brightening Eye Perfector Sunscreen Broad Spectrum SPF25 - Light 10 Titanium Dioxide CREAM TOPICAL 20130524 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 18.8 mg/g N 20181231 10812-458_a7d64f38-bb2d-44ea-91bf-4edae6a0b4be 10812-458 HUMAN OTC DRUG Neutrogena Healthy Skin Brightening Eye Perfector Sunscreen Broad Spectrum SPF25 - Medium 15 Titanium Dioxide CREAM TOPICAL 20130524 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 18.8 mg/g N 20181231 10812-459_a7d64f38-bb2d-44ea-91bf-4edae6a0b4be 10812-459 HUMAN OTC DRUG Neutrogena Healthy Skin Brightening Eye Perfector Sunscreen Broad Spectrum SPF25 - Buff 09 Titanium Dioxide CREAM TOPICAL 20130524 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 18.8 mg/g N 20181231 10812-460_cf785a55-57de-4ffd-bab8-9ce400fe575b 10812-460 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF50 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 10; 30 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-503_05c45655-25e3-40ff-b8e2-60b439cb8167 10812-503 HUMAN OTC DRUG Neutrogena Ageless Essentials Continuous Hydration Daily Moisturizer SPF25 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 20; 40; 18; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-505_7e7e58ee-e943-48fc-b923-9249d67fe9bd 10812-505 HUMAN OTC DRUG Neutrogena TGel Therapeutic Stubborn Itch Coal Tar SHAMPOO TOPICAL 20081201 OTC MONOGRAPH FINAL part358H Johnson & Johnson Consumer Inc. COAL TAR 5 mg/mL N 20181231 10812-506_8314c7fd-13b1-454b-89f2-1f3aa576f17a 10812-506 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Nude Salicylic Acid POWDER TOPICAL 20091130 20181201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 10812-508_e4ccb1bb-e42d-47da-8a81-47a4b56fe920 10812-508 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Classic Ivory Salicylic Acid POWDER TOPICAL 20091130 20181201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 10812-509_795fcb26-2c9b-42a6-b850-842ea422551c 10812-509 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Natural Ivory Salicylic Acid POWDER TOPICAL 20091130 20181201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 10812-510_1cbb8b00-4cae-4e57-a63e-9b046ef41471 10812-510 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Buff Salicylic Acid POWDER TOPICAL 20091130 20181201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 10812-511_f63a6897-94e4-4272-ad70-5a93184070b5 10812-511 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Soft Beige Salicylic Acid POWDER TOPICAL 20091130 20181201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 10812-512_fdd733e6-03c0-4476-8bfa-130a92051c46 10812-512 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Natural Beige Salicylic Acid POWDER TOPICAL 20091130 20181201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 10812-513_1d156223-c865-4817-b50f-2ca8f0416c82 10812-513 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Honey Beige Salicylic Acid POWDER TOPICAL 20091130 20181201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 10812-514_32875f7e-98e2-43b7-924b-3363bbe09916 10812-514 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Tan Salicylic Acid POWDER TOPICAL 20091130 20181201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 10812-519_e098a961-645b-4fed-a6a3-4eb5a069821d 10812-519 HUMAN OTC DRUG Neutrogena Skin Clearing Blemish Concealer - Fair 05 Salicylic Acid CREAM TOPICAL 20100205 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 5.5 mg/g N 20181231 10812-520_e098a961-645b-4fed-a6a3-4eb5a069821d 10812-520 HUMAN OTC DRUG Neutrogena Skin Clearing Blemish Concealer - Buff 09 Salicylic Acid CREAM TOPICAL 20100205 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 5.5 mg/g N 20181231 10812-521_e098a961-645b-4fed-a6a3-4eb5a069821d 10812-521 HUMAN OTC DRUG Neutrogena Skin Clearing Blemish Concealer - Light 10 Salicylic Acid CREAM TOPICAL 20100205 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 5.5 mg/g N 20181231 10812-522_e098a961-645b-4fed-a6a3-4eb5a069821d 10812-522 HUMAN OTC DRUG Neutrogena Skin Clearing Blemish Concealer - Medium 15 Salicylic Acid CREAM TOPICAL 20100205 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 5.5 mg/g N 20181231 10812-525_81d33914-9138-4acc-baa1-a1874095c93d 10812-525 HUMAN OTC DRUG Neutrogena Wet Skin Swim Humidity Sweat Sunscreen Broad Spectrum SFP45 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120919 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-528_b704d1fd-6b54-43e8-8706-f9cf3df387d8 10812-528 HUMAN OTC DRUG Neutrogena Wet Skin Kids Beach and Pool Sunscreen Broad Spectrum SPF45 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120919 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-529_07f535c9-7186-466e-86cc-5d271200a750 10812-529 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20110601 20180601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-531_a9bcc179-e5ef-44ef-bd47-fd079a1e8302 10812-531 HUMAN OTC DRUG Neutrogena Ultra Gentle Soothing Sunscreen Broad Spectrum SPF15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20120921 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL N 20181231 10812-532_66726a7a-4521-42b0-a892-c965d8f0635e 10812-532 HUMAN OTC DRUG Neutrogena Healthy Defense Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 23.5; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-534_cc4b10a6-9f79-441c-ac1b-0c537040abb5 10812-534 HUMAN OTC DRUG Neutrogena Healthy Defense Daily Moisturizer Sunscreen Broad Spectrum SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 23.5; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-535_2aa44e26-f584-4dfe-91f3-7e697f7e7598 10812-535 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-536_899d9472-9d5d-4fef-90bb-34083fbc2746 10812-536 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121017 20180801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-537_130b0ad9-1a99-4b30-be78-237e52e86536 10812-537 HUMAN OTC DRUG Neutrogena Triple Age Repair Moisturizer Broad Spectrum SPF25 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/g; mg/g; mg/g; mg/g N 20181231 10812-600_884674a1-1a49-4381-831a-025ee6ce76fd 10812-600 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Classic Ivory 10 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL N 20181231 10812-601_884674a1-1a49-4381-831a-025ee6ce76fd 10812-601 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Natural Ivory 20 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL N 20181231 10812-602_884674a1-1a49-4381-831a-025ee6ce76fd 10812-602 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Buff 30 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL N 20181231 10812-603_884674a1-1a49-4381-831a-025ee6ce76fd 10812-603 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Nude 40 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL N 20181231 10812-604_884674a1-1a49-4381-831a-025ee6ce76fd 10812-604 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Soft Beige 50 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL N 20181231 10812-605_884674a1-1a49-4381-831a-025ee6ce76fd 10812-605 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Natural Beige 60 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL N 20181231 10812-606_884674a1-1a49-4381-831a-025ee6ce76fd 10812-606 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Fresh Beige 70 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL N 20181231 10812-607_884674a1-1a49-4381-831a-025ee6ce76fd 10812-607 HUMAN OTC DRUG Neutrogena Shine Control Makeup Broad Spectrum SPF20 - Warm Beige 90 Titanium Dioxide LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation TITANIUM DIOXIDE 32 mg/mL N 20181231 10812-608_9c63214b-0536-49a5-9fbf-b39f3dbf2731 10812-608 HUMAN OTC DRUG Neutrogena Healthy Skin Primer Broad Spectrum SPF15 Avobenzone, Homosalate, and Octinoxate LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTINOXATE 20; 30; 40 mg/mL; mg/mL; mg/mL N 20181231 10812-611_3094abd2-7ff5-49e2-80aa-fa92e3972323 10812-611 HUMAN OTC DRUG Neutrogena Wet Skin Swim Humidity Sweat Sunscreen Broad Spectrum SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101001 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 100; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-612_fe7f84a8-287a-4a82-b492-5d6ed2d7c52c 10812-612 HUMAN OTC DRUG Neutrogena Wet Skin Kids Beach and Pool Sunscreen Broad Spectrum SPF70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 20120108 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 30 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-702_7cad333b-b96c-4374-995b-655253859be1 10812-702 HUMAN OTC DRUG Neutrogena Wet Skin Swim Humidity Sweat Sunscreen Broad Spectrum SPF85 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101016 20181001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-814_a7ad4a63-f8f9-4bbe-993c-aac119572568 10812-814 HUMAN OTC DRUG Neutrogena Ageless Intensives Tone Correcting Daily Moisturizer Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 40; 50; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-818_fc9f885c-7e5b-4c80-b0d5-4a0dccb6014f 10812-818 HUMAN OTC DRUG Neutrogena Ageless Restoratives Anti-Oxidant Daily Moisturizer SPF 20 Helioplex Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 18; 70; 40; 15; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-847_d51de58b-d488-4790-b4c9-edbf965d0f8d 10812-847 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Redness Soothing Cream Cleanser Salicylic Acid LOTION TOPICAL 20120329 20180609 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-848_9d46b526-41d9-4b66-aa0d-1f52e209b8dc 10812-848 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Redness Soothing Facial Cleanser Salicylic Acid SOLUTION TOPICAL 20120330 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-869_89dc4046-70b3-4c1a-baab-d1feb965b16e 10812-869 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control Night Cleansing Pads Salicylic Acid CLOTH TOPICAL 20110927 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/1 N 20181231 10812-872_5ddb685b-70c0-4cca-90d1-cdc6f23966eb 10812-872 HUMAN OTC DRUG Neutrogena Wet Skin Swim Humidity Sweat Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101001 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 80; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-873_10ef23ba-9a22-4ee8-befd-92d3a875d01f 10812-873 HUMAN OTC DRUG Neutrogena Ultra Sheer Sunscreen Broad Spectrum SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LIQUID TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 75; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-874_9d187c42-2892-4e98-b323-2a60d07f3e6c 10812-874 HUMAN OTC DRUG Neutrogena Norwegian Formula Lip Moisturizer SPF15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131017 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 40 mg/g; mg/g N 20181231 10812-900_26d38fce-6263-4024-b09e-a7fde3cc9d5e 10812-900 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Salicylic Acid CREAM TOPICAL 20110215 20180601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-901_d52c7594-0b40-4ff0-b776-451d1325ca4c 10812-901 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Face Oil free Sunscreen Broad Spectrum SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-913_7def4641-bf17-4f74-ba81-d201eaf9505c 10812-913 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Salicylic Acid GEL TOPICAL 20090201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-916_8bc13818-d7eb-41e0-aef4-e52cc25df86d 10812-916 HUMAN OTC DRUG Neutrogena T/Sal Therapeutic Salicylic Acid SHAMPOO TOPICAL 20111012 OTC MONOGRAPH FINAL part358H Neutrogena Corporation SALICYLIC ACID 30 mg/mL N 20181231 10812-920_a35f7298-7b4c-49a2-b358-e1a89e2c88a1 10812-920 HUMAN OTC DRUG Neutrogena TGel Therapeutic Coal Tar SHAMPOO TOPICAL 20120330 OTC MONOGRAPH FINAL part358H Johnson & Johnson Consumer Inc. COAL TAR 5 mg/mL N 20181231 10812-925_d8156bfe-8f0b-49cd-8a64-c3cf3791dc24 10812-925 HUMAN OTC DRUG Neutrogena Healthy Skin Face Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140301 20180501 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 15; 50; 30; 40 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-934_7087f53b-2272-4ac6-bdcf-25308704bc77 10812-934 HUMAN OTC DRUG Neutrogena Healthy Skin Face Sunscreen SPF 15 Octinoxate and Oxybenzone LOTION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/mL; mg/mL N 20181231 10812-945_a5da3e76-d732-476f-a18e-438967a87228 10812-945 HUMAN OTC DRUG Neutrogena T/Gel Therapeutic Extra Strength Coal Tar SHAMPOO TOPICAL 20120314 OTC MONOGRAPH FINAL part358H Neutrogena Corporation COAL TAR 10 mg/mL N 20181231 10812-973_a2da11b8-2b5c-4d4c-aca9-2cb6efd2194d 10812-973 HUMAN OTC DRUG Neutrogena Clear Pore Oil-Eliminating Astringent Salicylic Acid LIQUID TOPICAL 20110915 OTC MONOGRAPH FINAL part333D Neutrogena Corporation SALICYLIC ACID 20 mg/mL N 20181231 10812-975_a59e67d8-2219-4e88-ac25-beed850e0239 10812-975 HUMAN OTC DRUG Neutrogena Acne Control Benzoyl Peroxide LOTION TOPICAL 20140314 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 25 mg/mL N 20181231 10812-976_9b1b4526-465c-44ac-b9be-840b69029983 10812-976 HUMAN OTC DRUG Neutrogena Visibly Even BB Broad Spectrum SPF 30 Light to Medium Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20131015 20190101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-977_232ce1d6-663e-4295-8f6d-de25a7ca3b9a 10812-977 HUMAN OTC DRUG Neutrogena Visibly Even BB Broad Spectrum SPF 30 Fair to Light Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part352 Neutrogena Corporation HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-978_47a1818b-44ad-4d9a-9de4-32b1d980ae7d 10812-978 HUMAN OTC DRUG Neutrogena Healthy Skin Anti Wrinkle Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20140610 20180301 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 15; 50; 30; 40 mg/g; mg/g; mg/g; mg/g N 20181231 10812-979_d2cd6c4e-3aac-42dc-900f-c56575ef6531 10812-979 HUMAN OTC DRUG Neutrogena Oil Free Moisture Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 15; 50; 30; 40 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 10812-980_509f4e4c-39b2-4341-8a19-b397d2ce2d51 10812-980 HUMAN OTC DRUG Neutrogena Oil Free Acne Moisturizer Pink Grapefruit Salicylic Acid LOTION TOPICAL 20141015 20180301 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 10812-981_883ea1b8-3f2d-49d7-960e-8c67583589d9 10812-981 HUMAN OTC DRUG Neutrogena Rapid Clear Stubborn Acne Cleanser Benzoyl Peroxide LOTION TOPICAL 20141201 20180701 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 100 mg/mL N 20181231 10812-982_30cf79d0-4953-450d-80db-37937990c4f1 10812-982 HUMAN OTC DRUG Neutrogena Rapid Clear Stubborn Acne Spot Benzoyl Peroxide GEL TOPICAL 20140905 20180601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 100 mg/g N 20181231 10812-992_0f5027b4-a751-4775-9d38-91db9bc7f1b5 10812-992 HUMAN OTC DRUG Neutrogena Rapid Clear Stubborn Daily Leave On Mask Benzoyl Peroxide GEL TOPICAL 20151001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 25 mg/g N 20181231 10812-993_348641f9-09a0-4cae-8811-c6c1d75c4d03 10812-993 HUMAN OTC DRUG Neutrogena Healthy Skin Anti-Wrinkle System Avobenzone, Octisalate, Octocrylene, and Oxybenzone KIT 20150916 20180701 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. N 20181231 10812-994_794c58ae-4138-44bd-9d85-e11c83a6c920 10812-994 HUMAN OTC DRUG Neutrogena CoolDry Sport Sunscreen SPF 50 with Micromesh Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20150801 20190307 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27; 90; 45; 60; 45 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10812-995_76a80475-3223-40fc-aa2e-5f56d2d95935 10812-995 HUMAN OTC DRUG Neutrogena Complete Acne Therapy Solution Salicylic Acid, Avobenzone, Octisalate, Octocrylene, Oxybenzone, and Benzoyl Peroxide KIT 20151101 20181101 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. N 20181231 10812-996_0d587fa8-161d-4708-b37a-a857264e2478 10812-996 HUMAN OTC DRUG Neutrogena Body Clear Body Scrub Salicylic Acid SUSPENSION TOPICAL 20151114 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-997_04fc79b5-7b6e-45ae-91ca-90e506037d79 10812-997 HUMAN OTC DRUG Neutrogena Body Clear Body Wash Salicylic Acid SOLUTION TOPICAL 20151113 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-998_5d714ba3-bc2a-4ea3-bdf6-ef272ba00261 10812-998 HUMAN OTC DRUG Neutrogena Rapid Clear Acne Eliminating Spot Salicylic Acid GEL TOPICAL 20151201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 10812-999_51e0062d-1cec-45e7-b63b-0ede898cd535 10812-999 HUMAN OTC DRUG Neutrogena Wet Skin Kids Sunscreen Broad Spectrum SPF70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20151101 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 10816-102_104718d1-9ec4-45a7-b8cb-f85cc555d942 10816-102 HUMAN OTC DRUG BOOST REGROWTH FOR WOMEN MINOXIDIL LIQUID TOPICAL 20120301 ANDA ANDA203932 SHELBY PROFESSIONAL, INC. MINOXIDIL 2 g/100mL E 20171231 10819-1080_5bd86876-10ce-81f4-e053-2991aa0aa6cb 10819-1080 HUMAN OTC DRUG Prevantics Swab Chlorhexidine Gluconate and Isopropyl Alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL N 20181231 10819-1080_5beb5992-d25f-cc9f-e053-2991aa0a7393 10819-1080 HUMAN OTC DRUG Prevantics Swab Chlorhexidine Gluconate and Isopropyl Alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL N 20181231 10819-3737_753d76c0-282f-4a7b-b464-9773e5ea0bc1 10819-3737 HUMAN OTC DRUG PDI Benzalkonium Chloride Antiseptic Towelettes BZK CLOTH TOPICAL 19830101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mL/mL N 20181231 10819-3740_4fce67fc-491e-00df-e054-00144ff88e88 10819-3740 HUMAN OTC DRUG Benzalkonium Chloride BENZALKONIUM CHLORIDE SWAB TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .0013 g/mL N 20181231 10819-3883_c68d4786-e37e-4cfe-9db0-4145cfdce92f 10819-3883 HUMAN OTC DRUG PVP Iodine Prep Pad Medium and Large providone iodine SWAB TOPICAL 19780101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 10819-3885_c68d4786-e37e-4cfe-9db0-4145cfdce92f 10819-3885 HUMAN OTC DRUG PVP Iodine Prep Swabstick Ones and Threes providone iodine STICK TOPICAL 19780101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 10819-3890_279308f7-dc08-51b2-e054-00144ff88e88 10819-3890 HUMAN OTC DRUG PDI Duo-Swab Povidone-Iodine Antiseptic Prep and Scrub Swabsticks Ones Povidone Iodine STICK TOPICAL 19780101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 10819-3891_2792bb32-dc15-54f1-e054-00144ff8d46c 10819-3891 HUMAN OTC DRUG Povidone-Iodine Cleaning scrub Swabstick 1 and 3 swabsticks providone iodine STICK TOPICAL 19780101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 10819-3912_49192772-acb0-4f87-9c2e-58f829854881 10819-3912 HUMAN OTC DRUG PDI Alcohol Prep Pad Large and Medium Alcohol CLOTH TOPICAL 19720101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .7 mL/mL N 20181231 10819-3914_59293bb9-0cf1-995c-e053-2991aa0a6fff 10819-3914 HUMAN OTC DRUG PDI Alcohol Prep Pad Sterile Large and Medium Alcohol CLOTH TOPICAL 19720101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International Inc ALCOHOL .7 mL/mL N 20181231 10819-3915_5307869c-98d3-41e0-8881-548da1c25483 10819-3915 HUMAN OTC DRUG PDI Alcohol Swabstick Threes and Ones Alcohol STICK TOPICAL 19720101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .7 mL/mL N 20181231 10819-3916_d7185081-3ae3-47c7-b093-e35a0793aeaf 10819-3916 HUMAN OTC DRUG PDI Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .7 mL/mL N 20181231 10819-3917_0fb98869-69f8-4bf0-8b7a-e37ac423e5bc 10819-3917 HUMAN OTC DRUG PDI Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-3918_2fff2a3d-5eaa-346e-e054-00144ff8d46c 10819-3918 HUMAN OTC DRUG PDI Sani Hands Instant Hand Sanitizing Wipes CLOTH TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International Inc ALCOHOL .7 mL/mL N 20181231 10819-3922_3d0924fb-2e90-6928-e054-00144ff8d46c 10819-3922 HUMAN OTC DRUG Sani-Professional Sani-Hands made with Tencel Sani-hands 1ct SWAB TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International Inc. ALCOHOL .659 mL/mL N 20181231 10819-4075_5bebc80a-6a3d-5671-e053-2a91aa0a23df 10819-4075 HUMAN OTC DRUG Prevantics Maxi Swabstick chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL N 20181231 10819-4075_5bed0d08-e6b6-5b62-e053-2a91aa0a66b3 10819-4075 HUMAN OTC DRUG Prevantics Maxi Swabstick chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL N 20181231 10819-4075_7a2ed78c-adf5-4d09-87fe-4b42d14bbb9b 10819-4075 HUMAN OTC DRUG Prevantics swabstick chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL N 20181231 10819-4075_a3b52e49-df8a-4fdf-9f20-f666b89ac277 10819-4075 HUMAN OTC DRUG Prevantics swabstick chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL N 20181231 10819-4075_ffc1ac7b-117d-44b8-b1e2-e7d1d70fb3dd 10819-4075 HUMAN OTC DRUG Prevantics swabstick chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20130115 NDA NDA021524 Professional Disposables International, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 31.5; .7 mg/mL; mL/mL N 20181231 10819-5000_fb6a434d-52d7-42c2-8c5e-0b65a1c6abe1 10819-5000 HUMAN OTC DRUG PDI Sani-Hands ALC Antimicrobial Alcohol Gel Hand Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/1 N 20181231 10819-5001_b80ca27c-f95d-424b-878c-9b2a7d8b60e6 10819-5001 HUMAN OTC DRUG PDI Sani-Hands ALC Antimicrobial Alcohol Gel Hand Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/1 N 20181231 10819-5002_32e5f231-769f-44a0-842e-58b97b4ee100 10819-5002 HUMAN OTC DRUG PDI Sani-Hands ALC Antimicrobial Alcohol Gel Hand Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-5003_bc42e327-c946-4622-b7f8-b23c64f0a708 10819-5003 HUMAN OTC DRUG PDI Sani-Hands ALC Antimicrobial Alcohol Gel Hand Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-5004_5cfa09ac-47bf-495d-8c2d-72a507828224 10819-5004 HUMAN OTC DRUG PDI Sani-Hands for Kids Antimicrobial Alcohol Gel Hand Wipes Alcohol CLOTH TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-5005_37d819e9-37ed-4ef1-938b-f2e18d894faf 10819-5005 HUMAN OTC DRUG PDI Sani-Hands for Kids Antimicrobial Alcohol Gel Hand Wipes Alcohol CLOTH TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-5802_ad71e347-1a74-4d54-b001-0546f4ca1815 10819-5802 HUMAN OTC DRUG Sani-Hands II Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-5808_2793fa4b-b7bc-1d8d-e054-00144ff8d46c 10819-5808 HUMAN OTC DRUG PDI Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20110825 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-5810_4b82d3a0-4fdf-4846-b590-8a9c458b7a45 10819-5810 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20120208 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/1 N 20181231 10819-5811_591f9ffe-a6e4-4c20-af70-c35be4df4a33 10819-5811 HUMAN OTC DRUG Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20120208 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/1 N 20181231 10819-5812_95f68516-214d-42c4-bfc5-8896d76f0400 10819-5812 HUMAN OTC DRUG Sani Professional Brand Sani-HandsInstant Hand Sani Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-5813_a78a877c-d46c-4a64-9423-593cacd599c7 10819-5813 HUMAN OTC DRUG PDI Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/1 N 20181231 10819-5814_172564ea-80b4-4d36-804b-8e9b541b80bf 10819-5814 HUMAN OTC DRUG PDI Sani-HandsInstant Hand Sani Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-6000_645c9b31-b443-4086-8ea1-1fa5ef6cd1e1 10819-6000 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Alcohol CLOTH TOPICAL 20100525 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/1 N 20181231 10819-6001_2ffab62f-a2fb-3d5c-e054-00144ff8d46c 10819-6001 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International Inc ALCOHOL .659 mL/mL N 20181231 10819-6002_2ffb3d53-3d8c-618b-e054-00144ff8d46c 10819-6002 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International Inc ALCOHOL .659 mL/mL N 20181231 10819-6003_c152f398-5780-48d9-a69c-7a62602fe6ff 10819-6003 HUMAN OTC DRUG Sani-Hands for Kids Alcohol CLOTH TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/1 N 20181231 10819-6004_1746f897-fd7a-48e7-988e-7f72089eb510 10819-6004 HUMAN OTC DRUG Sani Professional Brand Sani-Hands for Kids Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20100525 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-6005_fd097542-b65f-46e5-883c-1e8f58d8abc9 10819-6005 HUMAN OTC DRUG Sani Professional Brand Sani-Hands with Tencel Instant Hand Sanitizing Wipes Alcohol SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-7001_f2871bc2-0c80-4d3a-aba8-1befda4323da 10819-7001 HUMAN OTC DRUG Sani-Hands for Kids Antibacterial Moist Wipes Benzalkonium Chloride CLOTH TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .24 mg/mL N 20181231 10819-7002_1b9a9119-32c9-437b-9570-eab4d75066de 10819-7002 HUMAN OTC DRUG Sani Professional Brand Sanitizing Wipes Benzalkonium Chloride CLOTH TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 10819-7003_df8fc042-2d28-4c61-be03-532359563be4 10819-7003 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-7004_136849bc-ebf3-4fd0-a330-411b2bd14fba 10819-7004 HUMAN OTC DRUG Sani Professional Brand Sani-Hands for Kids Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-7005_59abc4f6-97ce-4582-866f-08891de8d646 10819-7005 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Profesional Disposables International, Inc. ALCOHOL .659 mL/mL N 20181231 10819-7006_e116f741-1c38-4513-a4ea-45a4ff5232a6 10819-7006 HUMAN OTC DRUG Nice and Clean Antibacterial Hand Wipes Benzalkonium Chloride CLOTH TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 10819-7007_276cded9-c8ea-2725-e054-00144ff88e88 10819-7007 HUMAN OTC DRUG Sani Professional Brand Sani-Hands BasicsHand Wipes Hand Wipes Benzalkonium Chloride CLOTH TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 10819-7008_bf33b5de-34c9-4cc7-a4ab-4e84734ccc1e 10819-7008 HUMAN OTC DRUG Sani Professional Brand Sani-Hands Basics BZKHand Wipes Hand Wipes Hand Wipes Hand Wipes Hand Wipes Hand Wipes Benzalkonium Chloride CLOTH TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 10819-7009_f7fff7a8-eb72-41d8-93d4-85f3ea708a1a 10819-7009 HUMAN OTC DRUG Sani Professional Brand Sani-Hands for KidsHand Wipes Hand Wipes Benzalkonium Chloride CLOTH TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 10819-7010_34f254d2-7b23-412a-bacc-69ebdea7fbb8 10819-7010 HUMAN OTC DRUG Sani-Hands for Kids Antibacterial Moist Wipes Benzalkonium Chloride CLOTH TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International, Inc. BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 10819-7011_3ad2e24a-a143-5fd3-e054-00144ff8d46c 10819-7011 HUMAN OTC DRUG Wet Naps Antibacterial Hand Wipes fresh Antibacterial Hand Wipes SWAB TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International Inc. BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 10819-7012_3ad21434-35e8-21e5-e054-00144ff88e88 10819-7012 HUMAN OTC DRUG Wet Nap Antibacterial Hand Wipes Benzalkonium Chloride CLOTH TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International Inc. BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 10819-7013_2bd54a6c-387e-3b2e-e054-00144ff88e88 10819-7013 HUMAN OTC DRUG Nice n clean Antibacterial Hand Wipes Antibacterial Hand Wipes SWAB TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International Inc BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 10819-7014_46eb64d5-38e6-05ce-e054-00144ff8d46c 10819-7014 HUMAN OTC DRUG Sani Pro Sani-Hands Antibacterial Wipe Antibacterial wipe SWAB TOPICAL 20161001 OTC MONOGRAPH NOT FINAL part333A Professional Disposables International Inc BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 10825-001_c9fef923-1bc9-45f8-b5f7-25abcbf73ae0 10825-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19740101 UNAPPROVED MEDICAL GAS Northern Welding Supply OXYGEN 99 L/100L E 20171231 10825-002_85a53027-c9f9-410f-ae5b-e8e970e8f1f6 10825-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19740101 UNAPPROVED MEDICAL GAS Northern Welding Supply OXYGEN 99 L/100L E 20171231 10825-003_25661f79-6d3a-4b03-961b-5c0186242b3e 10825-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20080701 UNAPPROVED MEDICAL GAS Northern Welding Supply NITROGEN 90 L/100L E 20171231 10827-0002_66fbcd67-91ef-4c3c-a973-7e2657d6242a 10827-0002 HUMAN OTC DRUG CLAIRES HAND SANITIZER GEL TOPICAL 20100115 OTC MONOGRAPH NOT FINAL part333 Yusef Manufacturing Laboratories, LLC ALCOHOL .62 g/g E 20171231 10827-0003_2595d684-91d4-4557-bf05-d74b0d7103a1 10827-0003 HUMAN OTC DRUG ICING HAND SANITIZER GEL TOPICAL 20100310 OTC MONOGRAPH NOT FINAL part333 Yusef Manufacturing Laboratories, LLC ALCOHOL .62 g/g E 20171231 10842-100_61fbd737-b243-2b26-e053-2a91aa0a06bd 10842-100 HUMAN OTC DRUG Doctor Hoys Natural Pain Relief menthol, camphor GEL TOPICAL 20050510 OTC MONOGRAPH NOT FINAL part348 DOCTOR HOY'S, LLC MENTHOL; CAMPHOR (NATURAL) 50; 50 mg/mL; mg/mL N 20191231 10842-200_5e4976c9-1b61-154c-e053-2a91aa0afca2 10842-200 HUMAN OTC DRUG DOCTOR HOYS Arnica Boost arnica montana, msm CREAM TOPICAL 20130801 UNAPPROVED DRUG OTHER DOCTOR HOY'S, LLC ARNICA MONTANA FLOWER; DIMETHYL SULFONE 5; 2 g/mL; g/mL N 20181231 10866-0087_1a4c0efc-bcfe-671f-e054-00144ff88e88 10866-0087 HUMAN PRESCRIPTION DRUG Precaine B Benzocaine Topical Anesthetic GEL DENTAL 20090427 UNAPPROVED DRUG OTHER Pascal Company, Inc. BENZOCAINE 221 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 10866-0088_5c8b27ab-3aec-f580-e053-2a91aa0a5919 10866-0088 HUMAN PRESCRIPTION DRUG Precaine B Bubblegum Benzocaine Topical Anesthetic GEL DENTAL 20160127 UNAPPROVED DRUG OTHER Pascal Company, Inc. BENZOCAINE 221 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 10866-0089_5c630601-5061-1d77-e053-2a91aa0a00b7 10866-0089 HUMAN PRESCRIPTION DRUG Precaine B Chocolate Vanilla Benzocaine Topical Anesthetic GEL DENTAL 20170816 UNAPPROVED DRUG OTHER Pascal Company, Inc. BENZOCAINE 221 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 10866-0090_5c63ebaf-c26c-2b92-e053-2991aa0a3a21 10866-0090 HUMAN PRESCRIPTION DRUG Precaine B Chocolate Mint Benzocaine Topical Anesthetic GEL DENTAL 20170816 UNAPPROVED DRUG OTHER Pascal Company, Inc. BENZOCAINE 221 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 10866-0093_12360727-2599-3365-e054-00144ff88e88 10866-0093 HUMAN PRESCRIPTION DRUG pH7 Gel Mint Topical Neutral Fluoride Gel GEL BUCCAL; DENTAL; TOPICAL 19930501 UNAPPROVED DRUG OTHER Pascal Company, Inc. SODIUM FLUORIDE 9.05 mg/g N 20181231 10866-0185_1233853f-01b0-6305-e054-00144ff88e88 10866-0185 HUMAN PRESCRIPTION DRUG 60 Second Taste Bubblegum Topical APF Fluoride Gel GEL BUCCAL; DENTAL; TOPICAL 19880401 UNAPPROVED DRUG OTHER Pascal Company, Inc. SODIUM FLUORIDE 12.3 mg/g N 20181231 10866-0285_129a945b-a007-5bb1-e054-00144ff88e88 10866-0285 HUMAN PRESCRIPTION DRUG 60 Second Taste Groovy Grape Topical APF Fluoride Gel GEL BUCCAL; DENTAL; TOPICAL 19880401 UNAPPROVED DRUG OTHER Pascal Company, Inc. SODIUM FLUORIDE 27.73 mg/g N 20181231 10866-0385_12354ac0-8665-3fdd-e054-00144ff8d46c 10866-0385 HUMAN PRESCRIPTION DRUG 60 Second Taste Mint Topical APF Fluoride Gel GEL BUCCAL; DENTAL; TOPICAL 19880401 UNAPPROVED DRUG OTHER Pascal Company, Inc. SODIUM FLUORIDE 27.73 mg/g N 20181231 10866-0485_15faabc3-34fc-2565-e054-00144ff8d46c 10866-0485 HUMAN PRESCRIPTION DRUG 60 Second Taste Orange Twist Topical APF Fluoride Gel GEL BUCCAL; DENTAL; TOPICAL 19931001 UNAPPROVED DRUG OTHER Pascal Company, Inc. SODIUM FLUORIDE 27.73 mg/g N 20181231 10866-0685_1235c694-a13a-4d07-e054-00144ff8d46c 10866-0685 HUMAN PRESCRIPTION DRUG 60 Second Taste Strawberry Topical APF Fluoride Gel GEL BUCCAL; DENTAL; TOPICAL 19880401 UNAPPROVED DRUG OTHER Pascal Company, Inc. SODIUM FLUORIDE 27.73 mg/g N 20181231 10866-0785_129c407b-49ed-3152-e054-00144ff8d46c 10866-0785 HUMAN PRESCRIPTION DRUG 60 Second Taste Marshmallow Topical APF Fluoride Gel GEL BUCCAL; DENTAL; TOPICAL 19880401 UNAPPROVED DRUG OTHER Pascal Company, Inc. SODIUM FLUORIDE 27.73 mg/g N 20181231 10866-0885_1287d2cd-9109-10cf-e054-00144ff88e88 10866-0885 HUMAN PRESCRIPTION DRUG 60 Second Taste Chocolate Vanilla Topical APF Fluoride Gel GEL BUCCAL; DENTAL; TOPICAL 20070115 UNAPPROVED DRUG OTHER Pascal Company, Inc. SODIUM FLUORIDE 27.73 mg/g N 20181231 10867-001_022623a8-79e7-4466-8931-3f62a6b825a8 10867-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20041001 NDA NDA205889 Mitchell Home Medical, Inc. OXYGEN 990 mL/L N 20181231 10882-527_2d139c48-1fd6-3073-e054-00144ff8d46c 10882-527 HUMAN OTC DRUG Lidopatch lidocaine, menthol PATCH TOPICAL 20160302 OTC MONOGRAPH NOT FINAL part348 J.A.R. Laboratories LIDOCAINE; MENTHOL .036; .0125 mg/1; mg/1 E 20171231 10882-527_4066d15a-ea84-4e54-b8f8-90af7100249d 10882-527 HUMAN OTC DRUG LidoPatch Pain Relief lidocaine and menthol PATCH TRANSDERMAL 20121213 OTC MONOGRAPH NOT FINAL part348 JAR Laboratories LIDOCAINE; MENTHOL 40; 50 mg/1; mg/1 E 20171231 10882-528_234197d4-6d60-0f55-e054-00144ff88e88 10882-528 HUMAN OTC DRUG LidoPatch Lidocaine, Menthol PATCH TOPICAL 20151029 OTC MONOGRAPH NOT FINAL part348 JAR Laboratories LIDOCAINE; MENTHOL 3.6; 1.25 g/1; g/1 E 20171231 10884-2228_8d89ba0f-3578-4071-97be-25386b4dccd7 10884-2228 HUMAN OTC DRUG BF-PARADAC Acetaminophen TABLET ORAL 20010919 OTC MONOGRAPH NOT FINAL part343 Bright Future Pharmaceuticals Factory ACETAMINOPHEN 500 mg/1 N 20181231 10885-002_34cbfcbb-47f1-3b60-e054-00144ff88e88 10885-002 HUMAN PRESCRIPTION DRUG SYNERA lidocaine and tetracaine PATCH CUTANEOUS 20131201 NDA NDA021623 Galen US Incorporated LIDOCAINE; TETRACAINE 70; 70 mg/1; mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 10885-003_c2f7c89c-d29d-4c2c-a2b9-432c3be4eb58 10885-003 HUMAN PRESCRIPTION DRUG Adasuve loxapine AEROSOL, POWDER RESPIRATORY (INHALATION) 20170926 NDA NDA022549 Galen US Incorporated LOXAPINE 10 mg/1 N 20181231 10888-5001_f196725f-4844-4a4e-b5df-40f8b1a2389f 10888-5001 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140327 ANDA ANDA202539 Banner Pharmacaps PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 10888-5002_f196725f-4844-4a4e-b5df-40f8b1a2389f 10888-5002 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140327 ANDA ANDA202539 Banner Pharmacaps PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 10888-5003_f196725f-4844-4a4e-b5df-40f8b1a2389f 10888-5003 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140327 ANDA ANDA202539 Banner Pharmacaps PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 10888-5006_cf6e5d46-d0fc-4708-99e9-c05169606e37 10888-5006 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20121101 ANDA ANDA078720 Banner Pharmacaps Inc AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] E 20171231 10888-7135_cfbb9566-cfae-4fd3-8256-384521cefcf0 10888-7135 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20140101 ANDA ANDA200900 Banner Pharmacaps PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 10888-7136_cfbb9566-cfae-4fd3-8256-384521cefcf0 10888-7136 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20140101 ANDA ANDA200900 Banner Pharmacaps PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 10889-100_705de695-7bac-4c0e-93fd-91fbd1feea2f 10889-100 HUMAN OTC DRUG Dial Gold Bar Antibacterial Deodorant Soap triclocarban SOAP CUTANEOUS 20090714 OTC MONOGRAPH NOT FINAL part333 VVF Kansas Services LLC TRICLOCARBAN .6 1/1 E 20171231 10889-102_e551d7ef-bd4b-4c8a-bfb5-3b734960e15f 10889-102 HUMAN OTC DRUG Family Dollar Celsius Antiperspirant Deodorant 2 oz stick aluminum zirconium tetrachlorohydrex gly STICK CUTANEOUS 20080404 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 1/1 E 20171231 10889-103_92380b63-78da-44ef-b05d-2015a04bd3b0 10889-103 HUMAN OTC DRUG Dead Down Wind ScentPrevent Antiperspirant Aluminum Chlorohydrate STICK CUTANEOUS 20080815 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM CHLOROHYDRATE 14.4 1/1 E 20171231 10889-105_454a03ff-f652-410a-830b-5ba3caf5f8d9 10889-105 HUMAN OTC DRUG Walgreens Original Antiperspirant Deodorant 2.7 oz aluminum zirconium tetrachlorohydrex gly STICK CUTANEOUS 20080404 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 16 1/1 E 20171231 10889-106_b32a37b4-19e7-4f49-a97f-b1cc37982ce8 10889-106 HUMAN OTC DRUG Walgreens Active Stick Antiperspirant Deodorant 3 oz aluminum zirconium tetrachlorohydrex gly STICK CUTANEOUS 20080404 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 1/1 E 20171231 10889-110_e3832b92-a779-488b-97b3-7c23be1d2e4b 10889-110 HUMAN OTC DRUG Lacura Extreme Blast anti-perspirant deodorant ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK CUTANEOUS 20101213 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 250 mg/g E 20171231 10889-111_c899a4f9-dae8-43b2-99de-5c27c1bef855 10889-111 HUMAN OTC DRUG Lacura Ultimate Endurance Pure Sport anti-perspirant deodorant ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK CUTANEOUS 20101213 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 250 mg/g E 20171231 10889-112_cdce1c44-7a77-45aa-959b-803eb29a14de 10889-112 HUMAN OTC DRUG Lacura Invisible Solid Powder Fresh anti-perspirant deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK CUTANEOUS 20101213 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 250 mg/g E 20171231 10889-113_da93fcb2-8155-4e70-b0b5-464faf6d6ba7 10889-113 HUMAN OTC DRUG Lacura Invisible Solid Shower Fresh anti-perspirant deodorant ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK CUTANEOUS 20101213 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 250 mg/g E 20171231 10889-128_5f4ccc11-0b7f-46ac-e053-2991aa0a74bd 10889-128 HUMAN OTC DRUG Modesa Antibacterial Bar Modesa Gold Antibacterial Bar Soap SOAP TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part333E VVF Kansas Services LLC BENZALKONIUM CHLORIDE .1 g/100g N 20181231 10889-129_5f4db6b7-99cd-31e8-e053-2991aa0aadce 10889-129 HUMAN OTC DRUG Modesa Antibacterial Bar Modesa Spring Fresh Antibacterial Bar Soap SOAP TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part333E VVF Kansas Services LLC BENZALKONIUM CHLORIDE .1 g/100g N 20181231 10889-201_5b42a290-b81b-4f66-8b53-b34f7254acef 10889-201 HUMAN OTC DRUG Walgreens Cool N Heat Therapy Pain Relief Stick Methyl Salicylate and Menthol STICK TOPICAL 20080815 OTC MONOGRAPH FINAL part348 VVF Kansas Services LLC METHYL SALICYLATE; MENTHOL 30; 10 1/1; 1/1 E 20171231 10889-202_2a497698-9a99-404c-aac8-cf48ffc43eb3 10889-202 HUMAN OTC DRUG CVS Cold and Hot Pain Relieving Stick Methyl Salicylate and Menthol STICK TOPICAL 20090327 OTC MONOGRAPH FINAL part348 VVF Kansas Services LLC METHYL SALICYLATE; MENTHOL 30; 10 1/1; 1/1 E 20171231 10889-203_5f4a4820-4dac-1715-e053-2991aa0aca5f 10889-203 HUMAN OTC DRUG Assured Menthol Relief Stick Menthol STICK TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part348 VVF Kansas Services LLC MENTHOL 1.34 g/57g N 20181231 10889-301_b3598ec2-9432-4870-bf1b-0f79c301b6ae 10889-301 HUMAN OTC DRUG DG Body Antibacterial Deodorant 3.5 oz bar triclocarban SOAP CUTANEOUS 20090710 OTC MONOGRAPH NOT FINAL part333 VVF Kansas Services LLC TRICLOCARBAN .6 1/1 E 20171231 10889-400_d1b2d809-f354-4956-a88c-86cd0467e554 10889-400 HUMAN OTC DRUG Soft and Dri Clinical Protection Everfresh Blossom Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130901 OTC MONOGRAPH FINAL part350 VVF Kansas Services, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 13 g/65g E 20171231 10889-409_5faecfc2-e7f8-d4c1-e053-2991aa0aeb6c 10889-409 HUMAN OTC DRUG POWER UP for Women Bloom Aluminum Zirconium Trichlorohydrex GLY 19% STICK TOPICAL 20120312 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 10.83 1/57g N 20181231 10889-410_5f8be1fe-7f64-3b6c-e053-2a91aa0ab7a3 10889-410 HUMAN OTC DRUG POWER UP DRIVE Aluminum Zirconium Trichlorohydrex GLY 19% STICK TOPICAL 20120312 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 13.49 g/71g N 20181231 10889-411_5f9c2638-f891-3f62-e053-2991aa0a3038 10889-411 HUMAN OTC DRUG POWER UP FORCE Aluminum Zirconium Trichlorohydrex GLY 19% STICK TOPICAL 20120312 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 13.49 g/71g N 20181231 10889-414_8a3c01e4-c4ec-4978-b5a5-1074000e597a 10889-414 HUMAN OTC DRUG Scent Blocker Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140601 OTC MONOGRAPH FINAL part350 VVF Kansas Services ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 12.8 g/64g N 20181231 10889-415_7afdf1d9-75a1-4e90-bb55-f8e2c2a4fc5f 10889-415 HUMAN OTC DRUG Bone Collector Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140601 OTC MONOGRAPH FINAL part350 VVF Kansas Services ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 12.8 g/64g N 20181231 10889-416_60f41949-03e5-fafa-e053-2a91aa0a20fb 10889-416 HUMAN OTC DRUG Scent Killer Gold Aluminum Zirconium Trichlorohydrex GLY STICK TOPICAL 20140801 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 12.8 g/64g N 20181231 10889-417_4df908bf-742b-4f9f-a0fa-b28b6bd68bd8 10889-417 HUMAN OTC DRUG Scent-A-Way Odor Control Aluminum Zirconium Trichlorohydrex GLY STICK TOPICAL 20120301 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 12.8 g/64g E 20171231 10889-418_ae21a213-250a-4b83-bffc-6a712f7a337d 10889-418 HUMAN OTC DRUG Scent-A-Way Odor Control Max Aluminum Zirconium Trichlorohydrex GLY STICK TOPICAL 20150515 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 12.8 g/64g N 20181231 10889-419_dd519140-b5cc-4d71-9b19-f0e6509ae2d0 10889-419 HUMAN OTC DRUG Control Freak Pit Stick Aluminum Zirconium Trichlorohydrex GLY STICK TOPICAL 20150701 OTC MONOGRAPH FINAL part350 VVF Kansas Services ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 11.65 g/64g N 20181231 10889-420_7d905487-bfcd-4152-9cbc-3052a7925f9e 10889-420 HUMAN OTC DRUG Dead down wind Scent Prevent Antiperspirant Aluminum Chlorohydrate 14.4% STICK TOPICAL 20150706 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM CHLOROHYDRATE 9.2 g/64g E 20171231 10889-421_60f2318c-f9b8-19ff-e053-2a91aa0a84cf 10889-421 HUMAN OTC DRUG Melaleuca Alloy Original Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20160505 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 10889-422_60f14e99-fa0e-6cef-e053-2a91aa0af98b 10889-422 HUMAN OTC DRUG Melaleuca Alloy Sport Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20160321 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 10889-423_60f07529-ef8d-0684-e053-2991aa0a7809 10889-423 HUMAN OTC DRUG Code Blue Scent Elimination Aluminum Zirconium Trichlorohydrex GLY STICK TOPICAL 20160603 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 10889-424_60efb728-13e7-0a34-e053-2a91aa0a6a59 10889-424 HUMAN OTC DRUG Novadore Duradry AM Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20161123 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 10889-425_5fafa80f-b816-3540-e053-2a91aa0a55de 10889-425 HUMAN OTC DRUG Soft and Dri Clinical Protection Fresh Pomegranate Aluminum Zirconium Trichlorohydrex Gly 20% STICK TOPICAL 20161128 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 10889-426_60e1c571-5a1d-badd-e053-2a91aa0ada02 10889-426 HUMAN OTC DRUG Dead Down Wind Antiperspirant Scent Prevent Aluminum Zirconium Trichlorohydrex GLY STICK TOPICAL 20160428 OTC MONOGRAPH FINAL part350 VVF Kansas Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 10893-083_2a3dc882-b840-4447-8e49-ad890292b3f5 10893-083 HUMAN OTC DRUG Naturasil Scabies Sulfur CREAM TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 1 [hp_X]/1 N 20181231 10893-150_fab0ab29-1f86-495f-829e-385594f5352e 10893-150 HUMAN OTC DRUG Naturasil Eczema Natrum Muriaticum LIQUID TOPICAL 20120202 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SODIUM CHLORIDE 6 [hp_X]/10mL N 20181231 10893-199_fbb31336-f8ed-4705-b30a-94f20bb702d4 10893-199 HUMAN OTC DRUG Naturasil Cherry Angiomas Phosphoricum Acidum LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation PHOSPHORIC ACID 6 [hp_X]/1 N 20181231 10893-200_71056361-0f5a-4be3-a98c-f1c74b0026e4 10893-200 HUMAN OTC DRUG Naturasil Jock Itch Sulfur LIQUID TOPICAL 20120202 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 N 20181231 10893-220_f2f3a41b-b9af-41d0-bc1b-6fbb5c8411e4 10893-220 HUMAN OTC DRUG Naturasil Ringworm Sulfur LIQUID TOPICAL 20120202 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 N 20181231 10893-240_bd9efb64-1216-4b37-bbb1-aab3affa2ab5 10893-240 HUMAN OTC DRUG Naturasil Tinea Versicolor Sulfur LIQUID TOPICAL 20120101 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/mL N 20181231 10893-240_e7429d1e-396d-4ebe-9ed9-c0db7e70263a 10893-240 HUMAN OTC DRUG Naturasil Tinea Versicolor Sulfur LIQUID TOPICAL 20120101 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/mL N 20181231 10893-260_5164432e-9195-41d0-b36b-946cabd21ed6 10893-260 HUMAN OTC DRUG Naturasil Athletes Foot Sulfur LIQUID TOPICAL 20120202 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 N 20181231 10893-270_c1045f80-0c15-4184-85b6-efb4c0bb19a3 10893-270 HUMAN OTC DRUG Naturasil Internal Parasites Sulfur LIQUID ORAL 20120111 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/30mL N 20181231 10893-300_14c63157-0582-495f-b8eb-7450b1d49583 10893-300 HUMAN OTC DRUG Naturasil Nail Fungus Thuja Occidentalis LIQUID TOPICAL 20120202 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 N 20181231 10893-335_740ab809-0ebc-430e-ba4d-c6a1e4c1e5f9 10893-335 HUMAN OTC DRUG Naturasil Scabies Sulfur LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 N 20181231 10893-342_2534251c-c25a-43f6-9696-f229e25b1a4c 10893-342 HUMAN OTC DRUG Naturasil Scabies Sulfur LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 N 20181231 10893-350_9b77405c-035e-4c3f-bf7f-9688dd27a875 10893-350 HUMAN OTC DRUG Naturasil Neuropathy Rub Hypericum and Arnica Montana LIQUID TOPICAL 20120111 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ST. JOHN'S WORT; ARNICA MONTANA 6; 1 [hp_X]/30mL; [hp_X]/30mL N 20181231 10893-359_bcfac0db-b3f3-4c67-84f0-6b8f425a7df6 10893-359 HUMAN OTC DRUG Naturasil Acne PHOSPHORIC ACID LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. PHOSPHORIC ACID 6 [hp_X]/1 N 20181231 10893-400_3f996ddf-656e-494a-bf1c-1d9f532752db 10893-400 HUMAN OTC DRUG Naturasil Scabies Sulfur LIQUID TOPICAL 20120202 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 N 20181231 10893-450_50fa61d9-ab73-4d82-8264-a75dd8a0d0b1 10893-450 HUMAN OTC DRUG Dr. Berrys APOTHECARY Muscle and Joint Pain Therapy Hypericum, Capsicum Annuum, Arnica Montana OIL TOPICAL 20120824 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ST. JOHN'S WORT; ARNICA MONTANA; CAPSICUM 6; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 10893-452_1cab59a1-25a1-4f21-bb44-91c0efc86275 10893-452 HUMAN OTC DRUG Naturasil Muscle and Joint Pain Hypericum 6X HPUS, Capsicum Annuum 3X HPUS, Arnica Montana 1X HPUS LIQUID TOPICAL 20121203 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ST. JOHN'S WORT; ARNICA MONTANA; CAPSICUM 6; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 10893-460_aeaab654-d446-4fec-8a7f-5cafa4bb4440 10893-460 HUMAN OTC DRUG Dr. Berrys APOTHECARY Gout Therapy Oil Capsicum Annuum, Arnica Montana, Hypericum OIL TOPICAL 20120822 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ST. JOHN'S WORT; ARNICA MONTANA; CAPSICUM 6; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 10893-462_bf6fe716-4a6e-4800-8633-d0ce06ec03ee 10893-462 HUMAN OTC DRUG Naturasil Gout Capsicum Annuum, Arnica Montana, Hypericum LIQUID TOPICAL 20121203 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. CAPSICUM; ARNICA MONTANA; ST. JOHN'S WORT 3; 1; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 10893-465_a5a04cfd-c1f6-45a0-becb-da23d2074fe7 10893-465 HUMAN OTC DRUG Dr. Berrys APOTHECARY Foot and Ankle Therapy Oil Capsicum Annuum, Hypericum, Arnica Montana OIL TOPICAL 20120822 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ST. JOHN'S WORT; ARNICA MONTANA; CAPSICUM 6; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 10893-470_bf446085-db38-40e4-8a18-16cdd8382950 10893-470 HUMAN OTC DRUG Dr. Berrys APOTHECARY Neuropathy Therapy Hypericum, Arnica Montana OIL TOPICAL 20120822 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ST. JOHN'S WORT; ARNICA MONTANA 6; 1 [hp_X]/mL; [hp_X]/mL N 20181231 10893-500_706a0dcb-90ec-4428-b0b1-49dc18127082 10893-500 HUMAN OTC DRUG Naturasil Molluscum Thuja Occidentalis LIQUID TOPICAL 20120113 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/mL N 20181231 10893-520_93726dd1-ae3f-458e-9dd8-95c1790c65b9 10893-520 HUMAN OTC DRUG Naturasil Skin Tags Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 N 20181231 10893-520_c4fb3f93-eb70-441c-8278-9e4ba4225c8c 10893-520 HUMAN OTC DRUG Naturasil Skin Tags Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 N 20181231 10893-540_ef3b4373-3e37-41e3-b9e1-2fabeda1c62a 10893-540 HUMAN OTC DRUG Naturasil Warts Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/mL N 20181231 10893-600_7aec57e4-7678-49ec-ad0f-768dba449051 10893-600 HUMAN OTC DRUG Naturasil Sulfur-Lavender Sulfur SOAP TOPICAL 20120118 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 1; 6 [hp_X]/g; [hp_X]/g N 20181231 10893-620_3d7be7eb-609b-4955-9356-006609458bfd 10893-620 HUMAN OTC DRUG Naturasil Tinea Versicolor Sulfur-Lavender SOAP TOPICAL 20120101 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 1; 6 [hp_X]/g; [hp_X]/g N 20181231 10893-625_46881a1a-2197-49e6-a5d5-fbb6fffe88e6 10893-625 HUMAN OTC DRUG Naturasil Athletes Foot Sulfur LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 N 20181231 10893-630_37e2533a-e8d5-42dc-9422-895d40648fca 10893-630 HUMAN OTC DRUG Naturasil Nail Fungus Sulfur and Thuja Occidentalis SOAP TOPICAL 20120113 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 1; 6 [hp_X]/127.6g; [hp_X]/127.6g N 20181231 10893-632_5f5dd8c9-231c-4f13-aee8-8acd578d01f1 10893-632 HUMAN OTC DRUG Naturasil Jock Itch Sulfur LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 N 20181231 10893-656_dd377be3-b78b-4dec-8522-41e0dcfe66b5 10893-656 HUMAN OTC DRUG Naturasil Nail Fungus Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 N 20181231 10893-663_d3bb3a3b-a667-4c9d-b434-16db9d49af37 10893-663 HUMAN OTC DRUG Naturasil Nail Fungus Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 N 20181231 10893-687_b4427511-4a39-4051-97ff-b7bdc63ca3a8 10893-687 HUMAN OTC DRUG Dermisil Warts Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 N 20181231 10893-694_98e54644-1a72-4671-b36b-5dc7189d1054 10893-694 HUMAN OTC DRUG Naturasil Warts Thuja Occidentalis LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 N 20181231 10893-710_33071a33-dd65-4517-a48d-fc3f4bb33491 10893-710 HUMAN OTC DRUG Naturasil Scars Silicea LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SILICON DIOXIDE 6 [hp_X]/mL N 20181231 10893-730_17589587-d400-44fc-81b1-6f0ddd0827e2 10893-730 HUMAN OTC DRUG Naturasil Stretch Marks Silicea LIQUID TOPICAL 20120112 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SILICON DIOXIDE 6 [hp_X]/mL N 20181231 10893-750_3e705b35-323e-4665-a498-ce9c51659745 10893-750 HUMAN OTC DRUG Naturasil Shingles Natrum Muriaticum LIQUID TOPICAL 20120112 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SODIUM CHLORIDE 6 [hp_X]/10mL N 20181231 10893-793_3022f4c8-ddf7-4a2f-a9ae-6620baa7717a 10893-793 HUMAN OTC DRUG Naturasil Bite Relief Phosphoricum Acidum LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. PHOSPHORIC ACID 6 [hp_X]/1 N 20181231 10893-892_1647f412-2755-4215-b6a9-828fe7832918 10893-892 HUMAN OTC DRUG Naturasil Ringworm Sulfur LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 N 20181231 10893-900_04f2d19c-40ed-4636-9012-4765e680e8ff 10893-900 HUMAN OTC DRUG CobraZol Arnica montana, Capsicum annum, Crotalus horridus, Lachesis muta, Naja tripudians GEL TOPICAL 20130821 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. ARNICA MONTANA; CAPSICUM; CROTALUS HORRIDUS HORRIDUS VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM 1; 2; 6; 8; 5 [hp_X]/88.721mL; [hp_X]/88.721mL; [hp_X]/88.721mL; [hp_X]/88.721mL; [hp_X]/88.721mL N 20181231 10893-908_3351ef57-59bd-4406-bab3-aa7c65270ac8 10893-908 HUMAN OTC DRUG Naturasil Ringworm SULFUR LIQUID TOPICAL 20111001 UNAPPROVED HOMEOPATHIC Nature's Innovation, Inc. SULFUR 6 [hp_X]/1 N 20181231 10913-001_60f4b344-638b-4c4d-e053-2a91aa0ab386 10913-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19620101 NDA NDA206023 Prest-O-Sales & Service Inc OXYGEN 99 L/100L N 20181231 10913-010_60f4b344-6396-4c4d-e053-2a91aa0ab386 10913-010 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20100101 NDA NDA206024 Prest-O-Sales & Service Inc NITROGEN 99 L/100L N 20181231 10922-825_a7594a20-f46e-4b33-91d5-410cc5e97b8d 10922-825 HUMAN PRESCRIPTION DRUG Finacea azelaic acid GEL TOPICAL 20041224 NDA NDA021470 Intendis Inc. AZELAIC ACID .15 g/g Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] E 20171231 10922-826_a7594a20-f46e-4b33-91d5-410cc5e97b8d 10922-826 HUMAN PRESCRIPTION DRUG Finacea azelaic acid KIT 20110412 NDA NDA021470 Intendis Inc. E 20171231 10922-828_71fcf85b-04ff-4630-872d-cd2df7ba6842 10922-828 HUMAN PRESCRIPTION DRUG DESONATE desonide GEL TOPICAL 20100128 NDA NDA021844 Intendis Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 10927-101_91db8774-345b-43e3-96d9-e303347744b1 10927-101 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19381020 NDA NDA205766 PURITY CYLINDER GASES INC NITROGEN 99 L/100L N 20181231 10927-102_952ddb7f-b486-4eac-84da-2d84580d84b1 10927-102 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19381020 NDA NDA209989 PURITY CYLINDER GASES INC NITROUS OXIDE 99 L/100L N 20181231 10927-103_f6958f43-361e-4c14-8198-fb6574519323 10927-103 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19381020 NDA NDA205767 PURITY CYLINDER GASES INC OXYGEN 99 L/100L N 20181231 10927-104_09de6b39-5b3a-4399-a8a9-5ce4aa737195 10927-104 HUMAN PRESCRIPTION DRUG AIR AIR GAS RESPIRATORY (INHALATION) 19381020 UNAPPROVED MEDICAL GAS PURITY CYLINDER GASES INC AIR 99 L/100L N 20181231 10927-104_97c17f01-770e-4d6e-8b30-ccb2c8a35390 10927-104 HUMAN PRESCRIPTION DRUG AIR AIR GAS RESPIRATORY (INHALATION) 19381020 NDA NDA205804 PURITY CYLINDER GASES INC AIR 99 L/100L N 20181231 10927-105_0e231de6-c60e-4c90-a2db-9f057e3a9319 10927-105 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN LIQUID RESPIRATORY (INHALATION) 19381020 NDA NDA205767 PURITY CYLINDER GASES INC OXYGEN 99 1/100L N 20181231 10927-106_116057e3-618f-4385-b881-7c7a85d955ee 10927-106 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN LIQUID RESPIRATORY (INHALATION) 19381020 NDA NDA205766 PURITY CYLINDER GASES INC NITROGEN 99 L/100L N 20181231 10942-1094_491e8fd8-8c11-46c6-a67c-b29f49cbe759 10942-1094 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19710101 UNAPPROVED MEDICAL GAS Welders Supply - Raimy Corporation OXYGEN 99 L/100L E 20171231 10942-1095_60de398b-c25a-5a8f-e053-2a91aa0aaa99 10942-1095 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930512 NDA NDA205865 Raimy Corporation OXYGEN 99.6 L/L N 20181231 10942-1096_60de787a-ff68-baaa-e053-2a91aa0a9c38 10942-1096 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 19930512 NDA NDA205865 Raimy Corporation OXYGEN 99.6 L/L N 20181231 10956-001_26656bbc-dca5-4c5c-be01-1066b1259382 10956-001 HUMAN OTC DRUG CVS Health Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER Reese Pharmaceutical Co PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 10956-002_f2cf26a0-a184-4dfa-9324-1d1dd20c7ad3 10956-002 HUMAN OTC DRUG CVS HEALTH Chest Congestion Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co GUAIFENESIN 400 mg/1 N 20181231 10956-003_74179880-e043-40b7-ba3a-8a3e7a5cc557 10956-003 HUMAN OTC DRUG CVS Chest Congestion Relief DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20091207 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 10956-004_c20959a2-8617-410c-842a-849c757dbe1a 10956-004 HUMAN OTC DRUG CVS Chest Congestion Relief PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 10956-014_c3ec7d96-290e-45e6-9f2e-4e7fb5420c10 10956-014 HUMAN OTC DRUG Care One Chest Congestion Relief DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20091207 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 10956-020_0a70b5ed-9dd4-43ab-8064-e4a5770b5d3b 10956-020 HUMAN OTC DRUG Premier Value Chest Congestion and cough releif DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20091130 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 10956-333_888aac36-5855-4ac9-8b66-15339f15b354 10956-333 HUMAN OTC DRUG Preferred Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20150115 UNAPPROVED DRUG OTHER Reese Pharmaceutical Co PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 10956-381_50b1e58e-07f2-43be-8795-9f6126928b8a 10956-381 HUMAN OTC DRUG Refenesen Chest Congestion Relief PE Guaifenesin/phenylephrine TABLET ORAL 20140925 OTC MONOGRAPH FINAL part341 REESE PHARMACEUTICAL CO. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 10956-523_c371090f-0d8a-41f8-bb01-ce4bebb2357a 10956-523 HUMAN OTC DRUG CVS Health Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20150115 UNAPPROVED DRUG OTHER Reese Pharmaceutical Co. PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 10956-551_8f84795b-121d-4590-973e-98059aa14995 10956-551 HUMAN OTC DRUG Preferred Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER Reese Pharmaceutical Co PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 10956-599_5fa7ee08-4ab0-49c3-b085-28c19a3261b6 10956-599 HUMAN OTC DRUG Family Wellness Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20150115 UNAPPROVED DRUG OTHER Reese Pharmaceutical Co PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 10956-618_b1025890-f97a-4f33-9000-9dd9de583da5 10956-618 HUMAN OTC DRUG Pinworm Medicine Pyrantal pamoate SUSPENSION ORAL 20070101 OTC MONOGRAPH FINAL part357B Reese Pharmaceutical Company PYRANTEL PAMOATE 144 mg/mL E 20171231 10956-674_bea99183-3189-4191-8d09-0c3cb986abc9 10956-674 HUMAN OTC DRUG Double Tussin Intense Cough Reliever DM Dextromethorphan Hydrobromide / Guaifenesin LIQUID ORAL 20110802 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 300 mg/5mL; mg/5mL N 20181231 10956-761_7a7843e4-292f-4bcf-8dfb-d0973f3407aa 10956-761 HUMAN OTC DRUG Freds Chest Congestion Relief DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20091130 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 10956-762_08c563b1-8efe-428b-bc73-ecc7318ee492 10956-762 HUMAN OTC DRUG Powerful Pain Medicine Acetaminophen TABLET ORAL 19900630 OTC MONOGRAPH NOT FINAL part343 REESE PHARMACEUTICAL CO. ACETAMINOPHEN 650 mg/1 N 20181231 10956-788_8c2f21fe-dc31-4c4d-9350-f80570271bf2 10956-788 HUMAN OTC DRUG Refenesen Chest Congestion Relief Guaifenesin TABLET ORAL 20030923 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co GUAIFENESIN 400 mg/1 N 20181231 10956-791_f6290f7a-6bb6-4686-aaf6-ffc3df8400d4 10956-791 HUMAN OTC DRUG Refenesen Chest Congestion Relief pe Guaifenesin/phenylephrine TABLET ORAL 20060220 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 10956-812_73013d4d-8946-42cc-8234-f56b523c16d0 10956-812 HUMAN OTC DRUG REESES ONETAB ALLERGY AND SINUS ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20100405 OTC MONOGRAPH FINAL part341 REESE PHARMACEUTICAL CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 10956-813_36179e63-1f04-41b1-97a5-90c425259f17 10956-813 HUMAN OTC DRUG REESES ONETAB COLD AND FLU ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20100405 OTC MONOGRAPH FINAL part341 REESE PHARMACEUTICAL CO. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 10956-814_f8f2cbdf-abec-4d20-b1e9-41f66b21dad1 10956-814 HUMAN OTC DRUG Reese ONETAB Congestion and cough Guaifenesin/phenylephrine TABLET ORAL 20100601 OTC MONOGRAPH FINAL part341 Reese Pharmaceutical Co GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 10967-057_3222fd3d-5e0c-40ac-ad46-9bef480bafab 10967-057 HUMAN OTC DRUG HI AND DRI ANTIPERSPIRANT ROLL-ON POWDER FRESH ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 19820101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM CHLOROHYDRATE .18 g/mL E 20171231 10967-100_381404fa-c532-46f5-a3b0-cab352c163dd 10967-100 HUMAN OTC DRUG Hi and Dri Antiperspirant Roll-On Unscented ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 19820101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM CHLOROHYDRATE .18 g/mL E 20171231 10967-582_454080bc-76d0-4b38-a2ec-8215692c9c52 10967-582 HUMAN OTC DRUG Mens Mitchum Advanced Invisible Roll-On Antiperspirant Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY LIQUID TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL E 20171231 10967-583_50ea516c-c1a6-4f98-bce9-ddcec2da99a9 10967-583 HUMAN OTC DRUG Womens Mitchum Advanced Invisible Roll-On Antiperspirant Deodorant Powder Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY LIQUID TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL E 20171231 10967-584_75ef2ef2-cf56-49b6-95c6-0e86d2017273 10967-584 HUMAN OTC DRUG Mens Mitchum Advanced Invisible Roll-On Antiperspirant Deodorant Sport ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY LIQUID TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL E 20171231 10967-586_421de883-5261-49de-a0dc-83fea72bf1e1 10967-586 HUMAN OTC DRUG Womens Mitchum Advanced Invisible Antiperspirant Deodorant Solid Powder Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g E 20171231 10967-587_908669e4-979b-43bf-a63b-e1e2cf160fde 10967-587 HUMAN OTC DRUG Womens Mitchum Advanced Invisible Antiperspirant Deodorant Solid Pure Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g E 20171231 10967-588_dd13ae33-9bab-4eab-8f59-036232b19323 10967-588 HUMAN OTC DRUG Womens Mitchum Advanced Invisible Antiperspirant Deodorant Solid Powder Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g E 20171231 10967-589_2652f533-5dc8-4a43-8164-2ef06ccf3892 10967-589 HUMAN OTC DRUG Womens Mitchum Advanced Invisible Antiperspirant Deodorant Solid Clean Control ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g E 20171231 10967-590_84877bd9-e305-42a3-aa4f-2eafd3825360 10967-590 HUMAN OTC DRUG Womens Mitchum Advanced Invisible Antiperspirant Deodorant Solid Sport ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g E 20171231 10967-595_2da3ebc7-1daa-439c-bbb7-c4fccd513559 10967-595 HUMAN OTC DRUG Womens Mitchum Clinical Antiperspirant Deodorant Soft Solid Powder Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/g N 20181231 10967-600_40f4cc70-6731-44ef-e054-00144ff88e88 10967-600 HUMAN OTC DRUG Hi and Dri Roll On aluminum chlorohydrate liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM CHLOROHYDRATE .18 g/mL N 20181231 10967-601_432b8c49-692a-2801-e054-00144ff88e88 10967-601 HUMAN OTC DRUG Mitchum Roll On Aluminum Zirconium Tetrachlorohydrex Gly LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-602_40f4cc70-6731-44ef-e054-00144ff88e88 10967-602 HUMAN OTC DRUG Hi and Dri Roll On aluminum chlorohydrate liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM CHLOROHYDRATE .18 g/mL N 20181231 10967-603_43186b7c-592d-4a0f-e054-00144ff8d46c 10967-603 HUMAN OTC DRUG Mitchum Clear Gel ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM SESQUICHLOROHYDRATE .25 g/mL N 20181231 10967-604_43186b7c-592d-4a0f-e054-00144ff8d46c 10967-604 HUMAN OTC DRUG Mitchum Clear Gel ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM SESQUICHLOROHYDRATE .25 g/mL N 20181231 10967-605_43186b7c-592d-4a0f-e054-00144ff8d46c 10967-605 HUMAN OTC DRUG Mitchum Clear Gel ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM SESQUICHLOROHYDRATE .25 g/mL N 20181231 10967-606_41487ca2-fce9-0ee3-e054-00144ff88e88 10967-606 HUMAN OTC DRUG Revlon New Complexion One-Step Perfect Make-Up Titanium Dioxide Make-Up PASTE TOPICAL 20140401 OTC MONOGRAPH FINAL part352 Revlon Consumer Products Corp TITANIUM DIOXIDE 4 mg/mL N 20181231 10967-607_43186b7c-592d-4a0f-e054-00144ff8d46c 10967-607 HUMAN OTC DRUG Mitchum Clear Gel ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM SESQUICHLOROHYDRATE .25 g/mL N 20181231 10967-608_43186b7c-592d-4a0f-e054-00144ff8d46c 10967-608 HUMAN OTC DRUG Mitchum Clear Gel ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM SESQUICHLOROHYDRATE .25 g/mL N 20181231 10967-609_432b8c49-692a-2801-e054-00144ff88e88 10967-609 HUMAN OTC DRUG Mitchum Roll On Aluminum Zirconium Tetrachlorohydrex Gly LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-611_43186b7c-592d-4a0f-e054-00144ff8d46c 10967-611 HUMAN OTC DRUG Mitchum Clear Gel ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM SESQUICHLOROHYDRATE .25 g/mL N 20181231 10967-612_43186b7c-592d-4a0f-e054-00144ff8d46c 10967-612 HUMAN OTC DRUG Mitchum Clear Gel ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM SESQUICHLOROHYDRATE .25 g/mL N 20181231 10967-613_4326c368-eae3-2dcb-e054-00144ff8d46c 10967-613 HUMAN OTC DRUG Mitchum Smart Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20091201 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-614_4326c368-eae3-2dcb-e054-00144ff8d46c 10967-614 HUMAN OTC DRUG Mitchum Smart Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20091201 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-616_414a3d61-5d1e-4a4f-e054-00144ff88e88 10967-616 HUMAN OTC DRUG Revlon Age Defying with DNA Advantage SPF 20 Octinoxate, Titanium Dioxide Make-Up LIQUID TOPICAL 20100901 OTC MONOGRAPH FINAL part352 Revlon Consumer Products Corp OCTINOXATE; TITANIUM DIOXIDE 3.5; 9.5 mg/mL; mg/mL N 20181231 10967-617_43152acb-cd94-2de5-e054-00144ff8d46c 10967-617 HUMAN OTC DRUG Mitchum Advanced Control Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-618_43152acb-cd94-2de5-e054-00144ff8d46c 10967-618 HUMAN OTC DRUG Mitchum Advanced Control Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-619_43152acb-cd94-2de5-e054-00144ff8d46c 10967-619 HUMAN OTC DRUG Mitchum Advanced Control Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-620_43152acb-cd94-2de5-e054-00144ff8d46c 10967-620 HUMAN OTC DRUG Mitchum Advanced Control Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-621_42771045-2909-5553-e054-00144ff8d46c 10967-621 HUMAN OTC DRUG REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15 Octinoxate, Titanium Dioxide Make-Up LIQUID TOPICAL 20130930 OTC MONOGRAPH FINAL part352 Revlon Consumer Products Corp OCTINOXATE; TITANIUM DIOXIDE 3.5; 4.3 mg/mL; mg/mL N 20181231 10967-622_42748194-73f1-5470-e054-00144ff8d46c 10967-622 HUMAN OTC DRUG Revlon Nearly Naked Makeup Octinoxate, Titanium Dioxide Make-Up LIQUID TOPICAL 20121119 OTC MONOGRAPH FINAL part352 Revlon Consumer Products Corp OCTINOXATE; TITANIUM DIOXIDE 3.5; 1.9 mg/mL; mg/mL N 20181231 10967-623_410ca372-4692-029d-e054-00144ff8d46c 10967-623 HUMAN OTC DRUG Revlon PhotoReady BB Cream Skin Perfector Octinoxate, Octisalate, Titanium Dioxide Make-Up LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Revlon Consumer Products Corp OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 5; 6.5 mg/mL; mg/mL; mg/mL N 20181231 10967-624_433c1e4f-b772-4eda-e054-00144ff88e88 10967-624 HUMAN OTC DRUG Revlon Mitchum Clinical Strength Soft Solid Aluminum Zirconium Tetrachlorohydrex Gly LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-625_433c1e4f-b772-4eda-e054-00144ff88e88 10967-625 HUMAN OTC DRUG Revlon Mitchum Clinical Strength Soft Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-626_433c1e4f-b772-4eda-e054-00144ff88e88 10967-626 HUMAN OTC DRUG Revlon Mitchum Clinical Strength Soft Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-627_433c1e4f-b772-4eda-e054-00144ff88e88 10967-627 HUMAN OTC DRUG Revlon Mitchum Clinical Strength Soft Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-629_43152acb-cd94-2de5-e054-00144ff8d46c 10967-629 HUMAN OTC DRUG Mitchum Advanced Control Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-630_410ca372-4687-029d-e054-00144ff8d46c 10967-630 HUMAN OTC DRUG Revlon Age Defying DNA Advantage CC Cream Octinoxate, Octisalate, Titanium Dioxide Make-Up LIQUID TOPICAL 20131028 OTC MONOGRAPH FINAL part352 Revlon Consumer Products Corp OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 5; 5.1 mg/mL; mg/mL; mg/mL N 20181231 10967-631_442f2a06-47ba-2522-e054-00144ff88e88 10967-631 HUMAN OTC DRUG REVLON PHOTOREADY INSTA-FIX MAKEUP titanium dioxide, zinc oxide STICK TOPICAL 20140914 OTC MONOGRAPH FINAL part352 Revlon Consumer Products Corp ZINC OXIDE; TITANIUM DIOXIDE 2.1; 4.7 mg/mL; mg/mL N 20181231 10967-632_43287217-d0ae-3229-e054-00144ff88e88 10967-632 HUMAN OTC DRUG Revlon Mitchum Clinical Gel Aluminum Zirconium Octachlorohydrex Gly liquid LIQUID TOPICAL 20151130 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .2 g/mL N 20181231 10967-633_43287217-d0ae-3229-e054-00144ff88e88 10967-633 HUMAN OTC DRUG Revlon Mitchum Clinical Gel Aluminum Zirconium Octachlorohydrex Gly liquid LIQUID TOPICAL 20151130 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .2 g/mL N 20181231 10967-634_432cbf25-d055-63f3-e054-00144ff8d46c 10967-634 HUMAN OTC DRUG Mitchum Sensitive Skin Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20151005 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-635_43158fa6-9a5d-1c85-e054-00144ff88e88 10967-635 HUMAN OTC DRUG Mitchum Advance Control Aluminum Chlorohydrate AEROSOL TOPICAL 20151207 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM CHLOROHYDRATE .25 g/mL N 20181231 10967-636_43158fa6-9a5d-1c85-e054-00144ff88e88 10967-636 HUMAN OTC DRUG Mitchum Advance Control Sport Aluminum Chlorohydrate AEROSOL TOPICAL 20151207 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM CHLOROHYDRATE .25 g/mL N 20181231 10967-637_43158fa6-9a5d-1c85-e054-00144ff88e88 10967-637 HUMAN OTC DRUG Mitchum Advance Control Powder Fresh Aluminum Chlorohydrate AEROSOL TOPICAL 20151207 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM CHLOROHYDRATE .25 g/mL N 20181231 10967-638_43158fa6-9a5d-1c85-e054-00144ff88e88 10967-638 HUMAN OTC DRUG Mitchum Advance Control Aluminum Chlorohydrate AEROSOL TOPICAL 20151207 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM CHLOROHYDRATE .25 g/mL N 20181231 10967-640_410d1cb2-6c8e-1ca3-e054-00144ff8d46c 10967-640 HUMAN OTC DRUG Revlon Kiss Balm SPF 20 Avobenzone, Benzophenone-3, Octinoxate STICK TOPICAL 20160919 OTC MONOGRAPH FINAL part352 Revlon Consumer Products Corp AVOBENZONE; OCTINOXATE; OXYBENZONE 2; 7.5; 3 g/mL; g/mL; g/mL N 20181231 10967-641_433c1e4f-b772-4eda-e054-00144ff88e88 10967-641 HUMAN OTC DRUG Revlon Mitchum Clinical Strength Soft Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-642_410d7127-6ab5-4972-e054-00144ff88e88 10967-642 HUMAN OTC DRUG Revlon Colorstay Liquid Makeup for Oily to Combination Skin Zinc Oxide, Titanium Dioxide Make-Up LIQUID TOPICAL 20141027 OTC MONOGRAPH FINAL part352 Revlon Consumer Products Corp ZINC OXIDE; TITANIUM DIOXIDE 2.1; 4.3 mg/mL; mg/mL N 20181231 10967-643_414538d6-9102-54bf-e054-00144ff8d46c 10967-643 HUMAN OTC DRUG Revlon Colorstay Liquid Makeup for Normal to Dry Skin Zinc Oxide, Titanium Dioxide Make-Up LIQUID TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Revlon Consumer Products Corp ZINC OXIDE; TITANIUM DIOXIDE 2.1; 4.3 mg/mL; mg/mL N 20181231 10967-644_43152acb-cd94-2de5-e054-00144ff8d46c 10967-644 HUMAN OTC DRUG Mitchum Advanced Control Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-645_43152acb-cd94-2de5-e054-00144ff8d46c 10967-645 HUMAN OTC DRUG Mitchum Advanced Control Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-646_433c1e4f-b772-4eda-e054-00144ff88e88 10967-646 HUMAN OTC DRUG Revlon Mitchum Clinical Strength Soft Solid Aluminum Zirconium Tetrachlorohydrex Gly liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .2 g/mL N 20181231 10967-647_43186b7c-592d-4a0f-e054-00144ff8d46c 10967-647 HUMAN OTC DRUG Mitchum Clear Gel ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM SESQUICHLOROHYDRATE .25 g/mL N 20181231 10967-648_43186b7c-592d-4a0f-e054-00144ff8d46c 10967-648 HUMAN OTC DRUG Mitchum Clear Gel ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM SESQUICHLOROHYDRATE .25 g/mL N 20181231 10967-649_43158fa6-9a5d-1c85-e054-00144ff88e88 10967-649 HUMAN OTC DRUG Mitchum Advance Control Pure Fresh Aluminum Chlorohydrate AEROSOL TOPICAL 20151207 OTC MONOGRAPH FINAL part350 Revlon Consumer Products Corp ALUMINUM CHLOROHYDRATE .25 g/mL N 20181231 10967-650_44424aac-cabf-4682-e054-00144ff88e88 10967-650 HUMAN OTC DRUG American Crew Pyrithione Zinc SHAMPOO TOPICAL 20130101 OTC MONOGRAPH FINAL part358H Revlon Consumer Products Corp PYRITHIONE ZINC 1 mg/mL N 20181231 10967-651_49c61db6-71bb-555e-e054-00144ff8d46c 10967-651 HUMAN OTC DRUG American Crew All In One Face Balm Broad Spectrum SPF 15 Octisalate,Homosalate,Avobenzone,Octocrylene LIQUID TOPICAL 20170401 OTC MONOGRAPH FINAL part352 Revlon Consumer Products Corp OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE 5; 5; 2; 2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11023-001_60f4052b-5c98-0fd2-e053-2991aa0a85d6 11023-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030101 NDA NDA206023 Corp Brothers Holdings, LLC OXYGEN 990 mL/L N 20181231 11023-003_60f3df1b-a36b-bc8e-e053-2a91aa0aad46 11023-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19800101 NDA NDA206024 Corp Brothers Holdings, LLC NITROGEN 990 mL/L N 20181231 11026-2639_2b42c80e-66ae-4a04-8fa0-935d164f2584 11026-2639 HUMAN OTC DRUG Kola-Pectin DS Bismuth Subsalicylate LIQUID ORAL 20071001 OTC MONOGRAPH FINAL part335 Seyer Pharmatec, Inc. BISMUTH SUBSALICYLATE 525 mg/15mL E 20171231 11026-2650_9146a6b6-cbaf-4304-b52f-6e6251b3f350 11026-2650 HUMAN OTC DRUG Broncotron S Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20121215 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/5mL; mg/5mL E 20171231 11026-2662_02031407-0572-4c92-92c7-47084ad2da9d 11026-2662 HUMAN OTC DRUG Panatuss Pediatric Drops DXP Dexbrompheniramine Maleate, Dextromethorphan, Phenylephrine LIQUID ORAL 20050901 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE .5; 5; 2.5 mg/mL; mg/mL; mg/mL E 20171231 11026-2675_4de7dbba-7d73-400f-bf64-ea96d8dc5cdd 11026-2675 HUMAN OTC DRUG Panatuss DXP Dexbrompheniramine Maleate, Dextromethorphan, Phenylephrine LIQUID ORAL 20050901 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 20; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 11026-2775_53748220-e18b-47ff-8850-6cecd3f17917 11026-2775 HUMAN OTC DRUG Panatuss PED Chlophedianol Hydrchloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride LIQUID ORAL 20121215 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 25; 2; 60 mg/5mL; mg/5mL; mg/5mL N 20181231 11026-2780_2a832371-f2dd-4fee-960b-4af3cc78b83e 11026-2780 HUMAN OTC DRUG Broncotron PED Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121215 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 350; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 11026-2785_a328acf9-7f88-4073-83f5-c6584b2b78b4 11026-2785 HUMAN OTC DRUG Panatuss PED Chlophedianol Hydrchloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride SOLUTION/ DROPS ORAL 20121215 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 6.25; .5; 15 mg/mL; mg/mL; mg/mL N 20181231 11026-2790_fa918a9a-eb8d-4206-a777-7b5c975101d9 11026-2790 HUMAN OTC DRUG Broncotron PED Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20121215 OTC MONOGRAPH FINAL part341 Seyer Pharmatec, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 11043-001_60ada880-845f-017b-e053-2a91aa0af518 11043-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860101 NDA NDA205767 S. J. Smith Co., Inc. OXYGEN 992 mL/L N 20181231 11043-002_60ad8387-8623-c596-e053-2a91aa0a7b2e 11043-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19860101 NDA NDA205766 S. J. Smith Co., Inc. NITROGEN 990 mL/L N 20181231 11045-0303_fe955d71-6dc5-48ca-9c81-bf990fca3f97 11045-0303 HUMAN OTC DRUG Soleo Organics Sunscreen Zinc Oxide CREAM TOPICAL 20070120 OTC MONOGRAPH NOT FINAL part352 Skin Elements USA, LLC ZINC OXIDE 223 mg/g E 20171231 11054-004_1ed76633-3240-42f0-9d3a-f76848879395 11054-004 HUMAN PRESCRIPTION DRUG HELIUM HELIUM GAS INTRACORONARY; RESPIRATORY (INHALATION) 19971106 NDA NDA205843 AIRGAS USA, LLC HELIUM 992 mL/L N 20181231 11054-005_f1b2c383-7585-4168-8744-64741d1a0042 11054-005 HUMAN PRESCRIPTION DRUG NITROGEN Compressed, NF NITROGEN GAS RESPIRATORY (INHALATION) 19971106 NDA NDA205839 AIRGAS USA, LLC NITROGEN 992 mL/L N 20181231 11054-006_1cfdc001-42c5-413d-9ff4-00852651f70e 11054-006 HUMAN PRESCRIPTION DRUG Nitrogen, Refrigerated Nitrogen, Refrigerated LIQUID CUTANEOUS 19971106 NDA NDA205839 AIRGAS USA, LLC NITROGEN 992 mL/L N 20191231 11054-007_3e7686b5-ea88-498b-b25f-90eaaa417288 11054-007 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19971106 NDA NDA206009 AIRGAS USA, LLC NITROUS OXIDE 992 mL/L N 20191231 11054-009_cf00e799-dd62-4a31-9b48-5e395d888171 11054-009 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS CUTANEOUS; RESPIRATORY (INHALATION) 19971014 NDA NDA205840 AIRGAS USA, LLC OXYGEN 992 mL/L N 20181231 11054-010_3cf05e32-cb8c-4748-bb34-ab586c867594 11054-010 HUMAN PRESCRIPTION DRUG Oxygen, Refrigerated Oxygen, Refrigerated GAS RESPIRATORY (INHALATION) 19971014 NDA NDA205840 AIRGAS USA, LLC OXYGEN 992 mL/L N 20181231 11054-999_44080e69-2564-01cf-e054-00144ff8d46c 11054-999 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20150101 UNAPPROVED MEDICAL GAS Airgas USA, LLC OXYGEN 100 L/99L E 20171231 11056-001_5e9c0ab8-bedc-4bc0-8023-22c498b9636d 11056-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19620101 NDA NDA205849 South Jersey Welding Supply OXYGEN 99 L/100L N 20181231 11056-010_d8d6eedf-412f-4916-bd23-dc3e5fbacce9 11056-010 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20100101 NDA NDA205850 South Jersey Welding Supply NITROGEN 99 L/100L N 20181231 11084-001_8ed0a1a5-1eaa-4c8d-ac44-fab12065044d 11084-001 HUMAN OTC DRUG Deb InstantFOAM Non-Alcohol PURE Benzalkonium Chloride LIQUID TOPICAL 20160907 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 11084-002_cb229328-1453-4cde-b6d7-1bbed3052c7b 11084-002 HUMAN OTC DRUG Deb InstantFOAM Non-Alcohol Benzalkonium Chloride LIQUID TOPICAL 20160907 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 11084-003_abdb4584-098c-49a5-8be5-16d29867d509 11084-003 HUMAN OTC DRUG Refresh ClearBac Fm Chloroxylenol LIQUID TOPICAL 20161012 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. CHLOROXYLENOL .5 g/100mL N 20181231 11084-004_59006d82-0c69-40fd-b1cb-7b49920fc99d 11084-004 HUMAN OTC DRUG AntiBAC FH FOAM Cucumber Aloe with Microhydration Triclosan, 0.7% SOLUTION TOPICAL 20170105 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. TRICLOSAN .7 g/mL N 20181231 11084-006_0f1b952a-fe81-4c01-b4ed-a368a0828980 11084-006 HUMAN OTC DRUG Alcare Extra Hand Sanitizer Alcohol SOLUTION TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 80 mL/100mL N 20181231 11084-007_4d763795-ac7b-485d-a832-9d41228d8bbe 11084-007 HUMAN OTC DRUG Soft N Sure Hand Sanitizer Benzalkonium Chloride SOLUTION TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 11084-010_a325fc72-37cc-4390-bb32-c2a9d8ea0310 11084-010 HUMAN OTC DRUG Refresh AntiBac FOAM Benzalkonium Chloride SOAP TOPICAL 20170612 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 g/L N 20181231 11084-013_8d8678de-b77f-41f5-a74f-4cc8aaeb3470 11084-013 HUMAN OTC DRUG Antibacterial Foam Benzalkonium Chloride SOLUTION TOPICAL 20170612 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 11084-014_9b7c6dde-89c3-431d-8195-675627da77fe 11084-014 HUMAN OTC DRUG Antimicrobial Foam Fragrance and Dye Free Benzalkonium Chloride SOLUTION TOPICAL 20170612 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 11084-015_8c4cc6b9-ad7f-44fe-91c2-e035f2dc9d9e 11084-015 HUMAN OTC DRUG Appeal Antibacterial Hand Wash Benzalkonium Chloride SOLUTION TOPICAL 20170612 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 11084-016_909b9760-32b9-47c3-af58-bf0e374eba57 11084-016 HUMAN OTC DRUG Clear Foaming Antimicrobial Benzalkonium Chloride SOLUTION TOPICAL 20170612 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 11084-017_7c1bda11-b9c7-4aa1-ad2f-3a101bcdced6 11084-017 HUMAN OTC DRUG InstantFOAM alcohol hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20080602 OTC MONOGRAPH NOT FINAL part333 Deb USA, Inc. ALCOHOL 72 mL/100mL E 20171231 11084-018_1eea95f1-995c-4610-900c-a760333513f4 11084-018 HUMAN OTC DRUG Astound Antibacterial Foam Benzalkonium Chloride SOLUTION TOPICAL 20170612 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 11084-019_8c050249-7aaa-4ed5-be82-526d0d9e73a7 11084-019 HUMAN OTC DRUG Frosty Green Antibacterial Foam Hand Benzalkonium Chloride SOLUTION TOPICAL 20170612 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 11084-020_0028140a-9c5f-48b2-b230-29b6eb279a5b 11084-020 HUMAN OTC DRUG Astound Antibacterial Triclosan LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL N 20181231 11084-021_8012c21f-e698-44b8-869a-67daa2c2ffa8 11084-021 HUMAN OTC DRUG Antibacterial Foam Benzalkonium Chloride SOLUTION TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE 1.3 g/L N 20181231 11084-031_9c426bb5-7535-4dd7-8003-43cf3562c16d 11084-031 HUMAN OTC DRUG Stokoderm Sun Protect 30 PURE Suncreen CREAM TOPICAL 20150601 OTC MONOGRAPH FINAL part352 Deb USA, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 10; 7.5; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 11084-040_a6650b96-9a5e-43e6-8bd4-a8d6d4c74815 11084-040 HUMAN OTC DRUG SBS 40 Allantoin LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN .5 mL/100mL E 20171231 11084-042_49cc3124-4c50-41d7-9d72-ad30761c7b9b 11084-042 HUMAN OTC DRUG Cool Melon Allantoin CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN .5 mL/100mL E 20171231 11084-050_398c87c2-15b0-4826-8cb2-273a6c581302 11084-050 HUMAN OTC DRUG Aerogreen Antibacterial Triclosan LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL E 20171231 11084-052_fb4b05a9-b90c-427b-9244-1d2994e4370b 11084-052 HUMAN OTC DRUG Bright Solutions Antibacterial Triclosan LIQUID TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL E 20171231 11084-053_38f523d6-7f8e-43e9-a044-fd62a8d66109 11084-053 HUMAN OTC DRUG AntiBac Foam Wash Triclosan, 0.30% LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL E 20171231 11084-054_0f853846-2a83-4f68-b251-1b9714fba870 11084-054 HUMAN OTC DRUG AgroBac Foam Wash Benzalkonium Chloride LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE 1.3 mL/100mL E 20171231 11084-054_966f10e3-6f96-4e0b-9eb4-74dd132fd80c 11084-054 HUMAN OTC DRUG AgroBac Foam Wash Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE 1.3 mL/100mL E 20171231 11084-057_dbb530e5-1e8e-464d-ad20-13ef30d75724 11084-057 HUMAN OTC DRUG InstantFOAM non-alcohol hand sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 11084-058_d68dd783-0c3e-4718-b9eb-bc7f6801448c 11084-058 HUMAN OTC DRUG InstantFOAM non-alcohol BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 11084-061_35a1c36f-2247-40e0-9c4c-221410452b3f 11084-061 HUMAN OTC DRUG DebMed Antimicrobial Body Wash and Shampoo Triclosan LIQUID TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .7 mL/100mL E 20171231 11084-062_e3bdfdb4-5470-4904-81c7-7de8ef25e0e8 11084-062 HUMAN OTC DRUG Deb Med Antimicrobial Foaming Hand Wash Fresh Grapefruit Triclosan LIQUID TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .7 mL/100mL E 20171231 11084-064_f1c99de9-c9d6-42aa-8035-24373229116b 11084-064 HUMAN OTC DRUG Deb Med Antimicrobial Foaming Hand Wash Cucumber Aloe Triclosan LIQUID TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .7 mL/100mL E 20171231 11084-066_172bdf6b-3c8e-4bc0-9b0b-605d17302e96 11084-066 HUMAN OTC DRUG Deb Med Antimicrobial Foaming Hand Wash Fragrance Free Dye Free Triclosan LIQUID TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .7 mL/100mL E 20171231 11084-068_4cba2741-738b-4fe9-876a-78e7c5791cfe 11084-068 HUMAN OTC DRUG Deb Med InstantFOAM Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20110201 20191101 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 mL/100mL N 20181231 11084-070_56a1cd23-abd5-4f82-a07a-1dec5b4bcb7e 11084-070 HUMAN OTC DRUG Aero IQ Antibacterial Quat Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE 1.3 mL/100mL E 20171231 11084-071_1622775a-6d32-4b42-b6ab-c73acf3463fb 11084-071 HUMAN OTC DRUG Aero CleansE2 Antibacterial Chloroxylenol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. CHLOROXYLENOL 2.1 mL/100mL E 20171231 11084-075_deec68a9-d7ed-4180-8b44-1e6a76ccf3f6 11084-075 HUMAN OTC DRUG SBS UltraGreen Triclosan GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .15 mL/100mL E 20171231 11084-076_e52d0550-98bf-4306-9b4c-0f216ed1e6d9 11084-076 HUMAN OTC DRUG Deb Gold Triclosan LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .15 mL/100mL E 20171231 11084-077_dbd8fc97-dc99-4924-9cc2-8fde2c282c5e 11084-077 HUMAN OTC DRUG SBS UltraPink Triclosan GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .15 mL/100mL E 20171231 11084-089_b746a878-24ad-464d-bc4a-59bc19659c06 11084-089 HUMAN OTC DRUG SBS Care Allantoin LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN .5 mL/100mL E 20171231 11084-100_67849b1a-fa80-4946-b4ba-80b9a9b2d15e 11084-100 HUMAN OTC DRUG Refresh AntiBac Foam Triclosan liquid LIQUID TOPICAL 20150415 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN 3 g/L N 20181231 11084-103_b62015e3-0059-4e51-9057-bcca8835259d 11084-103 HUMAN OTC DRUG ICI Pleasantly Perfumed Antibacterial Foam Handwash Triclosan SOAP TOPICAL 20150827 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .003 g/mL N 20181231 11084-105_30ccaded-fba9-4dd2-95db-b66f36a2b44f 11084-105 HUMAN OTC DRUG Appeal Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL E 20171231 11084-106_596d61fa-d223-4987-b35d-11d4fb982418 11084-106 HUMAN OTC DRUG Appeal Non-Alcohol Foaming Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 11084-107_99e14748-b100-43db-88e0-64da9673eb3e 11084-107 HUMAN OTC DRUG Appeal Alcohol Foaming Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 mL/100mL E 20171231 11084-110_21e3ec5a-de6c-47ab-83cf-a7808feb2c91 11084-110 HUMAN OTC DRUG Deb InstantFOAM Non-Alcohol Hand Sanitizer Benzalkonium Chloride liquid LIQUID TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE 1.3 g/L N 20181231 11084-111_c64412f6-2ed2-423c-8cdf-95577ad13a14 11084-111 HUMAN OTC DRUG Chemstar InstantFOAM NonAlcohol Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11084-112_dbb530e5-1e8e-464d-ad20-13ef30d75724 11084-112 HUMAN OTC DRUG Drummond Aero Instant Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 11084-113_dbb530e5-1e8e-464d-ad20-13ef30d75724 11084-113 HUMAN OTC DRUG United Labs Instant Foam Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL N 20181231 11084-114_92be4efa-bbf5-492d-84ae-f12ee0f302a9 11084-114 HUMAN OTC DRUG ICI Non-Alcohol Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20150827 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .0013 g/mL N 20181231 11084-115_675bfd17-dfae-4e7d-bdac-41674b9e63d4 11084-115 HUMAN OTC DRUG Panache Antibacterial Body Wash Triclosan LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .55 mL/100mL E 20171231 11084-116_59a50f19-4b23-4ff0-aaad-61b1c96bda17 11084-116 HUMAN OTC DRUG Deb Med Antibacterial Foam Hand Wash Triclosan LIQUID TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL E 20171231 11084-125_b9b86f6f-ab31-4cb5-a785-aa694e8db0bc 11084-125 HUMAN OTC DRUG AntiBac Foam Wash Triclosan LIQUID TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mL/100mL E 20171231 11084-129_dbb530e5-1e8e-464d-ad20-13ef30d75724 11084-129 HUMAN OTC DRUG Safe-T-Fresh Alcohol Free Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 11084-130_8305ff75-5ba3-4fae-ad8a-11d02e5a4de9 11084-130 HUMAN OTC DRUG Aero Florafree Antibacterial Chloroxylenol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. CHLOROXYLENOL .5 mL/100mL E 20171231 11084-131_90e910b6-bf3e-4462-a17e-d6c45d85b44c 11084-131 HUMAN OTC DRUG PureBac Foam Wash Chloroxylenol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. CHLOROXYLENOL .5 mL/100mL E 20171231 11084-136_d68dd783-0c3e-4718-b9eb-bc7f6801448c 11084-136 HUMAN OTC DRUG Hy5 Soapopular Aero Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 11084-137_d68dd783-0c3e-4718-b9eb-bc7f6801448c 11084-137 HUMAN OTC DRUG Paragon Aero Instant Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 11084-138_ec998333-5772-4d68-b681-14922737f8b1 11084-138 HUMAN OTC DRUG Hy5 Alcohol Free Fragrance Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 11084-141_3a8d22c9-c86c-42a8-a2cc-5ff84164cc27 11084-141 HUMAN OTC DRUG SBS 41 Medicated Cream Allantoin CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN 5 mg/mL N 20181231 11084-147_e97bd979-a1e4-402d-a836-068f3a9a73ff 11084-147 HUMAN OTC DRUG Action Chemical Antibac Clear Triclosan LIQUID TOPICAL 20130912 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-148_52c0ee4d-b938-4dab-ac44-0e683f17821c 11084-148 HUMAN OTC DRUG Deb Antimicrobial Fragrance and Dye Free Triclosan LIQUID TOPICAL 20130912 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-150_3c488d69-ede3-4582-ad58-f597b517e059 11084-150 HUMAN OTC DRUG Deb InstantFOAM PURE Non-Alcohol Hand Sanitizer Benzalkonium Chloride liquid LIQUID TOPICAL 20150415 20221201 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE 1.3 g/L N 20181231 11084-155_9ae7cf82-3446-4994-9b83-2fc84e235d20 11084-155 HUMAN OTC DRUG ICI Non-Alcohol Hand Sanitizer Dye and Fragrance Free Benzalkonium Chloride LIQUID TOPICAL 20150827 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .0013 g/mL N 20181231 11084-160_75edd0e8-700f-4a75-8ab4-95d22b8a2a17 11084-160 HUMAN OTC DRUG Refresh PureBac Foam Chloroxylenol LIQUID TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. CHLOROXYLENOL 5 g/L N 20181231 11084-161_8d65f87f-7605-4423-8030-c6736f6d46aa 11084-161 HUMAN OTC DRUG Healthy Hands Foaming Instant Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 11084-170_dd2be69f-ea4d-49ad-8f94-666e8d46cae1 11084-170 HUMAN OTC DRUG Deb InstantFOAM Complete Alcohol LIQUID TOPICAL 20150818 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL .8 mL/mL N 20181231 11084-175_6fc3086c-28fa-4df3-b1cd-61e1536fb412 11084-175 HUMAN OTC DRUG SBS UltraGreen Triclosan LIQUID TOPICAL 20130725 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN 1.5 mg/100mL N 20181231 11084-200_ed8e2b7b-bb06-4035-93c9-9b277bd60b99 11084-200 HUMAN OTC DRUG Deb Med InstantFOAM OptiDose Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 mL/100mL N 20181231 11084-215_64dc5381-fa00-4918-931a-2af6ea4a727a 11084-215 HUMAN OTC DRUG Panache Triclosan LIQUID TOPICAL 20130724 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .5 mg/100mL N 20181231 11084-231_09d4ca00-a3e2-4034-ace6-9e61fbd92e17 11084-231 HUMAN OTC DRUG Deb PureBac Foam Wash Chloroxylenol LIQUID TOPICAL 20130903 20180401 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. CHLOROXYLENOL 5 mg/100mL N 20181231 11084-232_8bb5c349-2362-4eda-8bac-dbe35f2a73d7 11084-232 HUMAN OTC DRUG Clean Choice Antibacterial Chloroxylenol LIQUID TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. CHLOROXYLENOL 5 mg/100mL N 20181231 11084-240_d12f476d-35fd-4e9b-a4d7-ad5d26c98b90 11084-240 HUMAN OTC DRUG SBS 40 Allantoin CREAM TOPICAL 20130101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN 5 mg/100mL N 20181231 11084-241_094ca125-4ef9-4c3e-908e-ee6526fc45cb 11084-241 HUMAN OTC DRUG SBS 40 Medicated Cream Allantoin CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Deb USA, Inc. ALLANTOIN 5 mg/100mL N 20181231 11084-253_5106e7f4-cb9e-464b-9051-679b64656d1d 11084-253 HUMAN OTC DRUG AntiBac Foam Wash/Aerogreen Triclosan LIQUID TOPICAL 20130501 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-254_1a7b09d0-1134-42be-9afc-bb0e08ecdced 11084-254 HUMAN OTC DRUG Deb AgroBac Foam Wash Benzalkonium Chloride LIQUID TOPICAL 20130720 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 11084-255_5bcee5c2-6275-41f6-a958-dec1fa301f5a 11084-255 HUMAN OTC DRUG Clean Choice Foodservice Antibacterial Benzalkonium Chloride LIQUID TOPICAL 20130720 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 11084-532_43dc2b55-ef1a-43bb-bf8c-cbbd89e1e674 11084-532 HUMAN OTC DRUG AeroGreen Antibac Triclosan LIQUID TOPICAL 20130705 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-533_92935efc-4d04-41ea-b686-f9b4a1727a73 11084-533 HUMAN OTC DRUG Secure Antibac Triclosan LIQUID TOPICAL 20130705 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-534_9d1e3141-b2ce-40a5-b010-8ffa0aeaef0b 11084-534 HUMAN OTC DRUG Sentry Antibac Triclosan LIQUID TOPICAL 20130705 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-535_7861504e-9d59-4052-8426-7f13ba152fd5 11084-535 HUMAN OTC DRUG United Lab Antibac Triclosan LIQUID TOPICAL 20130705 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-536_c7ee5461-f838-485b-ba33-e330d97e6901 11084-536 HUMAN OTC DRUG Pioneer Antibac Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-537_842ac2c2-e7d9-44fb-b759-876c569bf6e4 11084-537 HUMAN OTC DRUG Delta Foremost Antibac Triclosan LIQUID TOPICAL 20130705 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-539_c5bee1cf-6f77-4a89-b48a-17e4b3fa20bd 11084-539 HUMAN OTC DRUG Chemstar Antibac Triclosan LIQUID TOPICAL 20130705 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-575_17df196c-cd26-4533-83f9-f9e7c55cea03 11084-575 HUMAN OTC DRUG Ultragreen Antibacterial Triclosan LIQUID TOPICAL 20120620 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .15 g/100mL N 20181231 11084-631_ef3261e8-9642-4713-8102-528b4e07e5e3 11084-631 HUMAN OTC DRUG Astound Antibac Triclosan LIQUID TOPICAL 20130705 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-634_4311212d-26df-4369-9a16-5a535492a999 11084-634 HUMAN OTC DRUG Bright Solutions Antibac Triclosan LIQUID TOPICAL 20130705 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-662_e12973c3-21c0-4b7a-9400-431fb4e2ecbe 11084-662 HUMAN OTC DRUG AntiBAC FH Pure FOAM Triclosan liquid LIQUID TOPICAL 20141113 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .7 g/mL N 20181231 11084-663_ea6649f2-ef00-45ef-84c2-5d5a63c75fe8 11084-663 HUMAN OTC DRUG ICI Food Handler Foam Wash Triclosan SOAP TOPICAL 20150827 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .007 g/mL N 20181231 11084-701_17678d6b-57c8-41fa-9131-4b5797467858 11084-701 HUMAN OTC DRUG CTCA Foaming Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20120515 20180801 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 mL/100mL N 20181231 11084-702_c9bf38d9-ec1d-4400-866c-2871fc9faa93 11084-702 HUMAN OTC DRUG Appeal Alcohol Foaming Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 mL/100mL N 20181231 11084-703_310af17d-ffc4-435a-8ccc-7d4bc70d6296 11084-703 HUMAN OTC DRUG Deb InstantFoam Alcohol Sanitizer Ethyl Alcohol LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 L/100L N 20181231 11084-704_4c3a2a52-ebca-48b6-bec8-0a79ec21e8f9 11084-704 HUMAN OTC DRUG Clean Choice Alcohol Sanitizer Ethyl Alcohol LIQUID TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL 70 L/100L N 20181231 11084-705_4205274e-4b84-4eb1-b957-9d9bc758e246 11084-705 HUMAN OTC DRUG ICI Alcohol Hand Sanitizer Alcohol LIQUID TOPICAL 20150827 OTC MONOGRAPH NOT FINAL part333E Deb USA, Inc. ALCOHOL .7 mL/mL N 20181231 11084-732_852d5ed9-b99c-4ac9-910d-3eab1d0ff515 11084-732 HUMAN OTC DRUG Appeal Antibac Triclosan LIQUID TOPICAL 20130705 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .3 mg/100mL N 20181231 11084-910_972e5ae5-aab2-4836-9f9a-3a060e947f1d 11084-910 HUMAN OTC DRUG Stoko Gel Instant Hand Sanitizer Ethyl alcohol LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. ALCOHOL 62 mL/100mL N 20181231 11084-916_83f4c8e4-38d1-4b12-9137-0fab4bacecb9 11084-916 HUMAN OTC DRUG Stoko Gel Free Instant Hand Sanitizer Ethyl alcohol LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. ALCOHOL 60 mL/100mL N 20181231 11084-920_cc0f2362-b8a8-4b33-849b-9e5db8684839 11084-920 HUMAN OTC DRUG Estesol Clear Triclosan LIQUID TOPICAL 20140601 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .5 g/100mL N 20181231 11084-922_430919c0-65e0-466a-a45a-5d2bb96b7f0e 11084-922 HUMAN OTC DRUG Estesol FH Benzalkonium Chloride LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. BENZALKONIUM CHLORIDE 2.5 g/100mL N 20181231 11084-924_3e3217ca-afe5-4672-ba2c-ba5fdbcf6dcb 11084-924 HUMAN OTC DRUG Estesol Gold Triclosan LIQUID TOPICAL 20140601 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .5 g/100mL N 20181231 11084-941_3f21e449-d435-4c6d-a46b-0cbe42b83f81 11084-941 HUMAN OTC DRUG Clinishield Instant Hand Sanitizer Ethyl alcohol LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. ALCOHOL 62 mL/100mL N 20181231 11084-943_b9432d45-2b51-4f87-9a9b-25791950293e 11084-943 HUMAN OTC DRUG CliniShield Health Care Personnel Handwash Triclosan LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN 1 g/100mL N 20181231 11084-950_f7d288c3-7f6b-4d34-aa84-4d5eff8e109d 11084-950 HUMAN OTC DRUG Stoko Refresh Antibacterial Foam Triclosan LIQUID TOPICAL 20140601 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .5 g/100mL N 20181231 11084-954_f0399d9c-7b3f-411f-980e-401697e72750 11084-954 HUMAN OTC DRUG Stoko Refresh Food Handler Foam Triclosan LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .5 g/100mL N 20181231 11084-958_8091592a-7b4e-4014-8cca-f428212a7b40 11084-958 HUMAN OTC DRUG Stoko Refresh Foaming Instant Hand Sanitizer Ethyl alcohol LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. ALCOHOL 68 mL/100mL N 20181231 11084-960_49c9e076-0616-43cd-bcb5-05fb51457ed1 11084-960 HUMAN OTC DRUG Stoko Refresh Foaming Instant Hand Sanitizer Ethyl alcohol LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. ALCOHOL 68 mL/100mL N 20181231 11084-962_cf4a8bcc-bde8-452a-b979-e867da5c62a7 11084-962 HUMAN OTC DRUG Stoko Refresh 4in1 Instant Hand Sanitizer Ethyl alcohol LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. ALCOHOL 62 mL/100mL N 20181231 11084-964_21848126-28f1-4ff3-a3fe-1b58c3bcb987 11084-964 HUMAN OTC DRUG Stoko Refresh 4in1 Instant Hand Sanitizer Sp. Ethyl alcohol LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. ALCOHOL 70 mL/100mL N 20181231 11084-966_902a6454-40c5-483c-ae74-6382be1c3ebf 11084-966 HUMAN OTC DRUG Stoko Refresh 4in1 Antibacterial Foam Wash Triclosan LIQUID TOPICAL 20140601 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .5 g/100mL N 20181231 11084-967_509db2a1-9b48-4986-9e1f-f325bb2b22ef 11084-967 HUMAN OTC DRUG Stoko Refresh 4in1 Food Handler Foam Triclosan LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .5 g/100mL N 20181231 11084-970_0c08c211-bce3-49c9-9961-6a559e06f7dc 11084-970 HUMAN OTC DRUG Stoko Sp. Antibacterial Cleanser Triclosan LIQUID TOPICAL 20140601 20200801 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. TRICLOSAN .5 g/100mL N 20181231 11084-973_bb0c87f5-b109-47e2-ae6c-9e92cc3c7bb0 11084-973 HUMAN OTC DRUG Stoko Sp. Instant Hand Sanitizer Ethyl alcohol LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Deb USA, Inc. ALCOHOL 63 mL/100mL N 20181231 11086-011_36e89b5a-a9ce-4643-a7d5-88ad831403de 11086-011 HUMAN OTC DRUG TARSUM PROFESSIONAL COAL TAR SHAMPOO TOPICAL 20131030 OTC MONOGRAPH FINAL part358H Summers Laboratories Inc COAL TAR 2 g/100mL N 20181231 11086-021_0856e4c5-4113-4fef-9ad8-3fd77cdab983 11086-021 HUMAN OTC DRUG TRIPLE MEDICATED FOR DIAPER RASH ZINC OXIDE PASTE TOPICAL 20131030 OTC MONOGRAPH FINAL part347 Summers Laboratories Inc ZINC OXIDE 12.8 g/100g N 20181231 11086-022_e078c7cb-46c4-4523-8f14-c6f4659ee352 11086-022 HUMAN OTC DRUG REZAMID SULFUR AND RESORCINOL LOTION TOPICAL 20131030 OTC MONOGRAPH FINAL part333D Summers Laboratories Inc SULFUR; RESORCINOL 5; 2 g/100mL; 1/100mL N 20181231 11086-028_7f8420ff-9bb2-4989-8978-7c469701be87 11086-028 HUMAN OTC DRUG LIQUIMAT ACNE TREATMENT AND COVER-UP SULFUR LIQUID TOPICAL 20131030 OTC MONOGRAPH FINAL part333D Summers Laboratories Inc SULFUR 3 g/100mL N 20181231 11086-030_d41f45e9-aebf-454c-a914-973daa886b32 11086-030 HUMAN PRESCRIPTION DRUG Keralyt salicylic acid GEL TOPICAL 20091101 UNAPPROVED DRUG OTHER Summers Laboratories Inc SALICYLIC ACID 6 g/100g N 20181231 11086-032_c0de33e9-17c1-43e2-8859-2805e821c81e 11086-032 HUMAN PRESCRIPTION DRUG VANOXIDE HC BENZOYL PEROXIDE, HYDROCORTISONE LOTION TOPICAL 20091101 UNAPPROVED DRUG OTHER Summers Laboratories Inc BENZOYL PEROXIDE; HYDROCORTISONE 5; .5 g/100g; g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 11086-037_5fb2f5c7-7ea0-42d8-abd5-445636991d1e 11086-037 HUMAN PRESCRIPTION DRUG DRITHO-CREME HP ANTHRALIN CREAM TOPICAL 20130101 UNAPPROVED DRUG OTHER Summers Laboratories Inc ANTHRALIN 1 g/100g N 20181231 11086-038_6e1a2fd6-f29a-4a91-88dd-8c666e8818d1 11086-038 HUMAN OTC DRUG Keralyt 3 PERCENT salicylic acid GEL TOPICAL 20131030 OTC MONOGRAPH FINAL part358H Summers Laboratories Inc SALICYLIC ACID 3 g/100g N 20181231 11086-040_7bf69bac-4bc9-4cd8-8785-10f18b6ce5b5 11086-040 HUMAN OTC DRUG TRIPLE PASTE-AF MICONAZOLE NITRATE OINTMENT TOPICAL 20131030 OTC MONOGRAPH FINAL part333C Summers Laboratories Inc MICONAZOLE NITRATE 2 g/100g E 20171231 11086-043_55632907-8757-11de-8a39-0800200c9a66 11086-043 HUMAN PRESCRIPTION DRUG Keralyt salicylic acid SHAMPOO TOPICAL 20091101 UNAPPROVED DRUG OTHER Summers Laboratories Inc SALICYLIC ACID 6 g/92.6mL N 20181231 11086-047_4fa31a15-8c51-4f53-ac93-b84128e6687f 11086-047 HUMAN PRESCRIPTION DRUG Keralyt salicylic acid KIT 20091101 UNAPPROVED DRUG OTHER SUMMERS LABORATORIES INC N 20181231 11086-105_82e94a1e-fe15-466f-8d00-545947557e16 11086-105 HUMAN OTC DRUG CUTAR COAL TAR LOTION TOPICAL 20131029 OTC MONOGRAPH FINAL part358H Summers Laboratories Inc COAL TAR 1.5 g/100mL E 20171231 11086-152_f4331f68-5d08-4b36-bdfe-84409f7c61ba 11086-152 HUMAN PRESCRIPTION DRUG KERALYT salicylic acid SHAMPOO TOPICAL 20131030 UNAPPROVED DRUG OTHER Summers Laboratories Inc SALICYLIC ACID 5 g/100mL N 20181231 11096-001_4ada891b-86e0-7dfa-5d4a-3f67269a3e7b 11096-001 HUMAN OTC DRUG Vermocks Pyrantel Pamoate SUSPENSION ORAL 20120426 OTC MONOGRAPH FINAL part357B Tarmac Products, Inc. PYRANTEL PAMOATE 144 mg/mL N 20181231 11096-190_017e5335-cec6-47fb-baf1-cee6a54c0bd5 11096-190 HUMAN OTC DRUG SANAFITIL Undecylenic Acid OINTMENT TOPICAL 19660824 OTC MONOGRAPH FINAL part333C Tarmac Products, Inc UNDECYLENIC ACID 100 mg/g E 20171231 11099-0001_9e9f0c2d-c3b4-43fb-9b1b-ec2236270e81 11099-0001 HUMAN OTC DRUG Aloe Vesta Daily Moisturizer 59 ml Dimethicone LOTION TOPICAL 20160609 OTC MONOGRAPH FINAL part347 Guest Packaging LLC. DIMETHICONE 1.77 g/59mL N 20181231 11099-0002_310e3cde-ca64-45e7-8328-82a66fab0d56 11099-0002 HUMAN OTC DRUG Sensi Care Body Cream Petrolatum, Dimethicone CREAM TOPICAL 20160609 OTC MONOGRAPH FINAL part347 Guest Packaging LLC. PETROLATUM; DIMETHICONE 25.5; 850 g/85g; mg/85g N 20181231 11099-0003_ab0fbab0-e4fb-4901-9d65-3e9a2abf07ef 11099-0003 HUMAN OTC DRUG Aloe Vesta Clear Antifungal 56g Miconazole Nitrate OINTMENT TOPICAL 20160609 OTC MONOGRAPH FINAL part333C Guest Packaging LLC. MICONAZOLE NITRATE 1.12 g/56g N 20181231 11099-0004_f2af7d04-297c-4686-aec9-053ec8224d81 11099-0004 HUMAN OTC DRUG Aloe Vesta Daily Moisturizer 118ml Dimethicone LOTION TOPICAL 20160609 OTC MONOGRAPH FINAL part347 Guest Packaging LLC. DIMETHICONE 3.54 g/118mL N 20181231 11099-0005_db3722ff-e3df-481c-97bb-d2dabac4ed25 11099-0005 HUMAN OTC DRUG Aloe Vesta Daily Moisturizer 236 ml Dimethicone LOTION TOPICAL 20160609 OTC MONOGRAPH FINAL part347 Guest Packaging LLC. DIMETHICONE 7.08 g/236mL N 20181231 11099-0006_6eef9827-acec-4b6a-acb9-21b91ad89525 11099-0006 HUMAN OTC DRUG Aloe Vesta Clear Antifungal 141g Miconazole Nitrate OINTMENT TOPICAL 20160609 OTC MONOGRAPH FINAL part333C Guest Packaging LLC. MICONAZOLE NITRATE 2.82 g/141g N 20181231 11103-001_ab0f733c-8f6b-46de-9f78-61f77113c9bc 11103-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140101 NDA NDA205849 Temple Industrial Welding Supply Co OXYGEN 990 mL/L N 20181231 11109-000_3fb2ec90-071e-5c34-e054-00144ff8d46c 11109-000 HUMAN OTC DRUG THAYERS TOPICAL PAIN RELIEVER MEDICATED SUPERHAZEL with ALOE VERA FORMULA CAMPHOR LIQUID TOPICAL 20130918 20180430 OTC MONOGRAPH NOT FINAL part348 Henry Thayer Company CAMPHOR (NATURAL) 1 mg/mL E 20171231 11109-001_3fb33bb3-a393-0940-e054-00144ff88e88 11109-001 HUMAN OTC DRUG THAYERS TOPICAL PAIN RELIEVER SUPERHAZEL with ALOE VERA FORMULA CAMPHOR PATCH TOPICAL 20130918 20180331 OTC MONOGRAPH NOT FINAL part348 Henry Thayer Company CAMPHOR (NATURAL) .1 g/100g E 20171231 11110-0002_60f25837-ddb1-6269-e053-2991aa0ac9d8 11110-0002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040923 NDA NDA206023 Alegent Health OXYGEN 99.1 L/L N 20181231 11118-0073_4ec4fbe8-180e-4068-bd83-61f42e2963c5 11118-0073 HUMAN OTC DRUG Madina Acne SULFUR SOAP TOPICAL 20170501 OTC MONOGRAPH FINAL part333D Bradford Soap Works, Inc. SULFUR 3 g/100g N 20181231 11118-0119_23c71e29-3474-46bc-a42c-bb995b3922c0 11118-0119 HUMAN OTC DRUG X OUT CLEANSING BODY SALICYLIC ACID SOAP TOPICAL 20160601 OTC MONOGRAPH FINAL part358H Bradford Soap Works, Inc. SALICYLIC ACID .001 g/.1g N 20181231 11118-1002_e0501279-b35b-4823-bb81-cf500c388ed8 11118-1002 HUMAN OTC DRUG THYLOX SULFUR SOAP TOPICAL 20160601 OTC MONOGRAPH FINAL part333D Bradford Soap Works, Inc. SULFUR 3 g/100g N 20181231 11118-1209_2f67edc6-c536-4cdd-98ec-b6020c05d560 11118-1209 HUMAN OTC DRUG Proactive Solution Cleaning Bar SALICYLIC ACID SOAP TOPICAL 20100901 OTC MONOGRAPH FINAL part358H Bradford Soap Works, Inc. SALICYLIC ACID 1 g/100g N 20181231 11118-7386_f9e4e80e-aaf8-47c0-8c0d-6a3ae05581d6 11118-7386 HUMAN OTC DRUG PALMERS SKIN SUCCESS SULFUR SOAP TOPICAL 20160615 OTC MONOGRAPH FINAL part333D Bradford Soap Works, Inc. SULFUR 3 g/100g N 20181231 11150-370_f92904ad-7396-40ac-858e-46138f88b9fb 11150-370 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20150223 OTC MONOGRAPH NOT FINAL part333A Roundy's Supermarkets, Inc ALCOHOL 70 mL/100mL N 20181231 11291-070_27ebe620-1449-4e78-ae17-5136b3717c78 11291-070 HUMAN OTC DRUG Dr Tichenors First Aid Antispetic Alcohol GEL TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333E Dr. G. H. Tichenor's Antiseptic Company ALCOHOL 7 mL/10mL N 20181231 11291-243_b3191efa-fc07-4c04-88a6-3cb6b244f57f 11291-243 HUMAN OTC DRUG Dr Tichenors Toothpaste With Extra Whitening and Tartar Control Sodium Fluoride PASTE ORAL 20121024 OTC MONOGRAPH FINAL part355 Dr. G. H. Tichenor's Antiseptic Company SODIUM FLUORIDE 2.43 mg/g N 20181231 11324-001_2f3a2426-06ad-4481-a21d-9bbc7165ffd8 11324-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair, Puerto Rico Inc OXYGEN 990 mL/L N 20181231 11324-002_a86ada72-cdbf-4049-bead-f3ab8290c5ff 11324-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20051001 UNAPPROVED MEDICAL GAS Praxair, Puerto Rico Inc NITROGEN 990 mL/L N 20181231 11324-003_26c76239-8e8f-4fc0-9fac-21030bf9040b 11324-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20051001 UNAPPROVED MEDICAL GAS Praxair, Puerto Rico Inc CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 11324-005_bbf7c5a7-cc8d-491f-b4f0-0f6280bdffc9 11324-005 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 20011207 UNAPPROVED MEDICAL GAS Praxair, Puerto Rico Inc. HELIUM 990 mL/L N 20181231 11324-006_4978cceb-f514-4565-9df2-1416e0150de5 11324-006 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20051001 UNAPPROVED MEDICAL GAS Praxair, Puerto Rico Inc. OXYGEN 210 mL/L N 20181231 11324-498_7c44e1a4-6eab-4eff-ae64-8d1dd48830d5 11324-498 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20130522 NDA NDA205850 Praxair, Puerto Rico Inc NITROGEN 990 mL/L N 20181231 11324-720_7c44e1a4-6eab-4eff-ae64-8d1dd48830d5 11324-720 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130522 NDA NDA205849 Praxair, Puerto Rico Inc OXYGEN 990 mL/L N 20181231 11331-001_0e929bcb-6da3-4dbe-a169-5c12c08d0b27 11331-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091106 UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 99 L/100L E 20171231 11344-001_7cb3ba88-1242-48b7-9f5b-21a6065604db 11344-001 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20141010 OTC MONOGRAPH FINAL part344 Sound Drug ISOPROPYL ALCOHOL 613 mg/mL N 20181231 11344-002_4b6192e8-a8b5-432e-8919-d46f137ad99d 11344-002 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Sound Body HYDROGEN PEROXIDE 30 mg/mL N 20181231 11344-003_7d4f2951-3bb3-49bf-a935-3d6ef38105f2 11344-003 HUMAN OTC DRUG 50% Rubbing Isopropyl Alcohol LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Sound Body ISOPROPYL ALCOHOL 500 mg/mL N 20181231 11344-013_3ec7e7a6-f2c8-4dda-bf80-edaed3e60a14 11344-013 HUMAN OTC DRUG Lanolin, Petrolatum Lanolin, Petrolatum OINTMENT TOPICAL 20171003 OTC MONOGRAPH FINAL part347 Vi-Jon, Inc. LANOLIN; PETROLATUM 133; 459 mg/g; mg/g N 20181231 11344-053_f780e8c7-9d09-42fc-80b7-d67248de039f 11344-053 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20090105 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL N 20181231 11344-069_b3a5a3a3-739a-4941-8531-37b05b5aec14 11344-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Vi-Jon PETROLATUM 1 g/g N 20191231 11344-072_b9be94f9-8391-4ea5-9fc8-9a6fcbefe78e 11344-072 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20090815 OTC MONOGRAPH NOT FINAL part348 Vi Jon EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 11344-078_d9bd5e99-8373-42d1-954b-9f50590206d3 11344-078 HUMAN OTC DRUG Castor Oil Castor Oil LIQUID ORAL 20081209 OTC MONOGRAPH NOT FINAL part334 Vi-Jon, Inc. CASTOR OIL 1 g/mL N 20181231 11344-088_983bb033-337b-445b-b979-352d0a64c36b 11344-088 HUMAN OTC DRUG Iodine Iodine LIQUID TOPICAL 20081108 OTC MONOGRAPH NOT FINAL part333A Vi-Jon IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 11344-089_a3e4a7a1-d73f-4351-a426-33f2533c6002 11344-089 HUMAN OTC DRUG Germ-X Alcohol LIQUID TOPICAL 20160222 OTC MONOGRAPH NOT FINAL part333A Vi Jon, Inc ALCOHOL 62 mg/mL N 20181231 11344-098_b17c387b-8ef5-4202-ac36-daf1a6e9729b 11344-098 HUMAN OTC DRUG Germ-X Alcohol LIQUID TOPICAL 20160222 OTC MONOGRAPH NOT FINAL part333A Vi Jon, Inc ALCOHOL 62 mg/mL N 20181231 11344-118_9ec52af3-c7ea-4b46-bf2a-9ad7e95e0ff0 11344-118 HUMAN OTC DRUG Foaming Hand Sanitizer Benzalkonium Chloride LOTION TOPICAL 20090105 OTC MONOGRAPH NOT FINAL part333A Vi-Jon BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11344-211_31c7b084-08fd-49bb-a94b-2667341555dd 11344-211 HUMAN OTC DRUG Isopropyl ISOPROPYL ALCOHOL LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ISOPROPYL ALCOHOL 924 mg/mL N 20181231 11344-231_1acc2c72-e392-4ffe-9d0d-51b688b36bb3 11344-231 HUMAN OTC DRUG Hand Sanitizing Wipes Ethyl Alcohol CLOTH TOPICAL 20090105 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 620 mg/mL N 20181231 11344-234_60dac5cc-6873-4cd9-aceb-4d24010db645 11344-234 HUMAN OTC DRUG Germ-X Alcohol LIQUID TOPICAL 19990712 OTC MONOGRAPH NOT FINAL part333A Vi Jon, Inc ALCOHOL 63 mg/mL N 20181231 11344-235_fc5cf9f5-f3cb-4a7c-a78f-29dd6b6dec30 11344-235 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20110126 OTC MONOGRAPH FINAL part347 Vi-Jon PETROLATUM 99.8 g/100kg N 20191231 11344-245_0c95482a-aa72-45de-940f-8dc67435136c 11344-245 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20090916 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 837 mg/mL N 20181231 11344-248_7620914c-2764-44d4-86de-43d74393f24a 11344-248 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20170623 OTC MONOGRAPH FINAL part341 Vi-Jon CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/g; kg/g; kg/g N 20181231 11344-253_5db44039-cdbb-443c-88eb-21d9a05f60c0 11344-253 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20160531 OTC MONOGRAPH FINAL part358H Vi-Jon, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 11344-269_9f22e806-22e1-4a9c-8942-f3af254d750b 11344-269 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20131004 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL N 20181231 11344-279_645b60b9-12d3-4c1f-ad38-dde38bcb6ed9 11344-279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20170327 OTC MONOGRAPH NOT FINAL part333A Vi-Jon BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 11344-297_52940621-d386-442d-bc64-7863ae1a813f 11344-297 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140314 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 567 mg/mL N 20181231 11344-318_defbe48f-2b1c-417e-9ccc-1e90988de31f 11344-318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20010104 OTC MONOGRAPH NOT FINAL part356 Vi-Jon EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 11344-379_b8e6c8d0-dafd-4d56-a0ae-1a84bbe3cd15 11344-379 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 19921021 OTC MONOGRAPH NOT FINAL part348 Vi-Jon MENTHOL 1.5 mg/g N 20181231 11344-391_db5cdf02-8421-43ad-b466-533ce413aff7 11344-391 HUMAN OTC DRUG Antibacterial Hand Wash Benzalkonium chloride 0.13% LIQUID TOPICAL 20160728 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc BENZALKONIUM CHLORIDE 1.313 mg/mL N 20181231 11344-396_f5caca83-b8c8-4b67-a10b-ac8567a30465 11344-396 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LOTION TOPICAL 20150206 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ALCOHOL 567 mg/mL N 20181231 11344-397_09c232b8-5ba6-4800-a3f0-b2b600cb3a34 11344-397 HUMAN OTC DRUG Vaporizing Camphor INHALANT RESPIRATORY (INHALATION) 20121003 OTC MONOGRAPH FINAL part341 Vi-Jon CAMPHOR (SYNTHETIC) 62 mg/mL N 20191231 11344-410_95254737-6c2e-4e92-b50e-eba910861dcb 11344-410 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 585 mg/mL N 20181231 11344-416_c803a8b0-8702-40eb-bb18-e94adb7499a1 11344-416 HUMAN OTC DRUG Antibacterial Hand Wash Benzalkonium chloride 0.13% LIQUID TOPICAL 20170327 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc BENZALKONIUM CHLORIDE 1.313 mg/mL N 20181231 11344-437_559add1b-3ad6-4e81-82f7-0e307b8b01d7 11344-437 HUMAN OTC DRUG Hand Sanitizer Alcohol LIQUID TOPICAL 20160613 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 63 mg/mL N 20181231 11344-439_9d374aa9-a152-4a3e-9b58-ea5489e0f481 11344-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120726 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc. ALCOHOL 700 mg/mL N 20191231 11344-443_fce97f61-de14-4056-9adc-84b7daad2246 11344-443 HUMAN OTC DRUG Dandruff pyrthione zinc SHAMPOO TOPICAL 20160617 OTC MONOGRAPH FINAL part358H Vi-Jon, Inc PYRITHIONE ZINC 10.4 mg/mL N 20181231 11344-447_fa6b5d95-9cf4-45fa-b52b-35dd76aad1b9 11344-447 HUMAN OTC DRUG Moisturizing Hand Sanitizer Ethyl Alcohol LOTION TOPICAL 20160503 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ALCOHOL .62 mL/mL N 20181231 11344-456_6ffb1889-2e08-4c3a-abf0-7172e22ee5e8 11344-456 HUMAN OTC DRUG Hand Sanitizer Alcohol LIQUID TOPICAL 20160610 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL .7 mL/mL N 20181231 11344-460_a96fba4b-e97e-4a9b-9f49-e5e88112beef 11344-460 HUMAN OTC DRUG Antibacterial Hand Wash Benzalkonium chloride 0.13% LIQUID TOPICAL 20160527 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc BENZALKONIUM CHLORIDE 1.313 mg/mL N 20181231 11344-461_f429b6f0-7d96-4770-9bb5-efc145aad1c6 11344-461 HUMAN OTC DRUG Dandruff pyrthione zinc SHAMPOO TOPICAL 20160617 OTC MONOGRAPH FINAL part358H Vi-Jon, Inc PYRITHIONE ZINC 1 mg/mL N 20181231 11344-465_94edbb9e-3c5d-4cae-8e91-698cc3c6ba62 11344-465 HUMAN OTC DRUG Antibacterial Hand Wash Ethyl Alcohol LIQUID TOPICAL 20160728 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ALCOHOL 1.313 mg/mL N 20181231 11344-466_7df27eed-49c0-4d48-923c-3b9dad766aa8 11344-466 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20160217 OTC MONOGRAPH NOT FINAL part333A Vi-Jon BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11344-467_ac7b9fff-33c8-402f-8bdd-18fc62d9c2ed 11344-467 HUMAN OTC DRUG Antibacterial Hand Wash Ethyl Alcohol LIQUID TOPICAL 20160728 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ALCOHOL 1.313 mg/mL N 20181231 11344-475_ee712803-de2f-4223-9984-54ce80ffc3ce 11344-475 HUMAN OTC DRUG Dandruff pyrthione zinc SHAMPOO TOPICAL 20160617 OTC MONOGRAPH FINAL part358H Vi-Jon, Inc PYRITHIONE ZINC 1 mg/mL N 20181231 11344-478_c80f9bcb-3958-49ed-8ff4-613626a0a17e 11344-478 HUMAN OTC DRUG Moisturizing Hand Sanitizer Benzethonium Chloride LOTION TOPICAL 20160503 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc BENZETHONIUM CHLORIDE 1.98 mg/g N 20181231 11344-484_54fa4327-48bf-4b52-a0fc-cbd2dae76835 11344-484 HUMAN OTC DRUG Handi Sani ALCOHOL LIQUID TOPICAL 20120402 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 62 mL/100L N 20181231 11344-488_454f79c3-f81a-42e7-9e09-09de1fc83104 11344-488 HUMAN OTC DRUG Antibacterial Hand Wash Benzalkonium chloride 0.13% LIQUID TOPICAL 20160527 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc BENZALKONIUM CHLORIDE 1.313 mg/mL N 20181231 11344-531_5c91c737-5a1b-4995-8f74-869382e7f4ba 11344-531 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 20160316 OTC MONOGRAPH FINAL part358H Vi-Jon, Inc PYRITHIONE ZINC 958 mg/mL N 20181231 11344-538_d6f47167-da4f-4796-9fae-b2bb57fc921e 11344-538 HUMAN OTC DRUG Moisturizing Hand Sanitizer Ethyl alcohol GEL TOPICAL 20090105 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 558 mg/mL N 20181231 11344-541_27db6dbd-7702-4bda-b1ce-53b3c1d438b4 11344-541 HUMAN OTC DRUG Antibacterial Liquid Hand TRICLOSAN LIQUID TOPICAL 20090730 OTC MONOGRAPH NOT FINAL part333A Vi Jon TRICLOSAN .115 kg/100L N 20181231 11344-544_6cf5916c-ec55-470c-9d33-768401ed0222 11344-544 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140314 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 567 mg/mL N 20181231 11344-554_3982d822-122c-4f68-a6ac-6a3a2a5f2be2 11344-554 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL N 20181231 11344-566_dbdf8c9f-22d8-4e9c-b730-0edf5dabb302 11344-566 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20100729 OTC MONOGRAPH FINAL part347 Vi-Jon PETROLATUM 1 g/g N 20181231 11344-575_c5d59851-659e-4f47-9c88-cec3f0a672cf 11344-575 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20170315 OTC MONOGRAPH NOT FINAL part333A Vi-Jon BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 11344-603_462adf6d-cc7a-4c06-93d9-9238ebcae17b 11344-603 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LOTION TOPICAL 20050419 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ALCOHOL 558 mg/mL N 20181231 11344-604_9c82ecfa-8f5e-489f-8898-6809b1b24dd0 11344-604 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140314 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 567 mg/mL N 20181231 11344-612_c588239f-c2ab-436b-8007-21f064bf3b4f 11344-612 HUMAN OTC DRUG 2 in 1 Dandruff Pyrithione zinc SHAMPOO TOPICAL 20161206 OTC MONOGRAPH FINAL part358H Vi-Jon PYRITHIONE ZINC 1 g/mL N 20181231 11344-616_de276c2b-5195-4dbf-aa0b-bb24f336891b 11344-616 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LOTION TOPICAL 20050419 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ALCOHOL .073 mL/100L N 20181231 11344-626_4d414362-170b-4122-ac67-e4775f0796d3 11344-626 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20131004 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL N 20181231 11344-633_481330ae-218c-4a15-8f14-8b4c7a646251 11344-633 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20170319 OTC MONOGRAPH NOT FINAL part333A Vi-Jon BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 11344-644_27168a6c-8ac1-4088-8b1f-fc8a1f72d741 11344-644 HUMAN OTC DRUG Soft Wipes Alcohol Free Antibacterial Benzalkonium Chloride (0.13%) CLOTH TOPICAL 20090105 OTC MONOGRAPH NOT FINAL part333A VI-JON BENZALKONIUM CHLORIDE .0013 mg/100mg N 20181231 11344-646_4b225001-ca41-42d4-8252-bc37674ca93a 11344-646 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140729 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 558 mg/mL N 20181231 11344-663_133defb0-686d-479b-a9aa-58e31d948eef 11344-663 HUMAN OTC DRUG Crisp Apple Hand Sani Ethyl Alcohol LIQUID TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 585 g/mL N 20181231 11344-697_bdc13ead-8542-4576-99e5-9164430a6c65 11344-697 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 558 mg/mL N 20181231 11344-710_523ea793-99ae-4675-b6e0-920f3dd6269f 11344-710 HUMAN OTC DRUG chloroxylenol chloroxylenol LIQUID TOPICAL 20170114 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc CHLOROXYLENOL 3.09 mg/mL N 20191231 11344-717_c3a403df-2086-434d-a0bc-3b8e5ed82546 11344-717 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol SPRAY TOPICAL 20160606 OTC MONOGRAPH NOT FINAL part333A Vi- Jon, Inc ALCOHOL .63 mL/mL N 20181231 11344-746_14413df9-802d-4c1f-b4b5-40e55c4ad025 11344-746 HUMAN OTC DRUG Germ-X Advanced Advanced Hand Sanitizer GEL TOPICAL 20170821 OTC MONOGRAPH NOT FINAL part333A Vi Jon, Inc ALCOHOL 700 mg/mL N 20191231 11344-747_4cb5db4f-2c86-4471-bc78-ae07805bead0 11344-747 HUMAN OTC DRUG Aloe Vera Gel Lidocaine HCl, Menthol GEL TOPICAL 20170324 OTC MONOGRAPH NOT FINAL part348 Vi-Jon LIDOCAINE HYDROCHLORIDE; MENTHOL 7; 2 mg/mL; mg/mL N 20181231 11344-766_8abbeeac-ea78-4fd5-82b1-d89b23970e7f 11344-766 HUMAN OTC DRUG Germ-X Alcohol LIQUID TOPICAL 20170821 OTC MONOGRAPH NOT FINAL part333A Vi Jon, Inc ALCOHOL 616 mg/mL N 20191231 11344-770_2f7717c4-1032-4c92-a912-4390734eebd5 11344-770 HUMAN OTC DRUG Germ-X Everywhere Advanced Hand Sanitizer GEL TOPICAL 20160328 OTC MONOGRAPH NOT FINAL part333A Vi Jon, Inc ALCOHOL 70 mL/100mL N 20181231 11344-775_3c30a342-8a90-45ef-9f56-4b5275cb5c09 11344-775 HUMAN OTC DRUG Germ-X Alcohol LIQUID TOPICAL 20160222 OTC MONOGRAPH NOT FINAL part333A Vi Jon, Inc ALCOHOL 62 mg/mL N 20181231 11344-791_1118bec1-0840-4cb7-b634-f85437651d37 11344-791 HUMAN OTC DRUG Kids Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20170701 OTC MONOGRAPH FINAL part352 Vi-Jon AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11344-801_100ecbd6-4625-407d-8f17-62d90ed8b9e3 11344-801 HUMAN OTC DRUG germ-X Soft Wipes Alcohol Free Antibacterial Benzalkonium Chloride (0.13%) CLOTH TOPICAL 20050401 OTC MONOGRAPH NOT FINAL part333A VI-JON BENZALKONIUM CHLORIDE .0013 mg/100mg N 20181231 11344-804_c0622c74-9f8b-4c35-9af9-ebcf6509c2ab 11344-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20170330 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ISOPROPYL ALCOHOL 91 mg/mL N 20181231 11344-817_257aa52e-8d97-490d-a7bc-a07ac8c3f027 11344-817 HUMAN OTC DRUG Handi Sani ALCOHOL LIQUID TOPICAL 20120402 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 62 mL/100L N 20181231 11344-821_5e881255-ac79-41dd-9614-f0d7fb34339d 11344-821 HUMAN OTC DRUG Acne Scrub Salicylic Acid GEL TOPICAL 20161027 OTC MONOGRAPH FINAL part333D Vi-Jon, Inc SALICYLIC ACID 21 mg/mL N 20181231 11344-905_2797f6e7-f81e-4662-9677-2b1688e87a97 11344-905 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140729 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 558 mg/mL N 20181231 11344-919_929e07f2-4f79-4a7a-8757-331124fd3b77 11344-919 HUMAN OTC DRUG Soft wipes Benzalkonium chloride CLOTH TOPICAL 19981113 OTC MONOGRAPH NOT FINAL part333A Vi-Jon BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 11344-928_6594fc72-7eeb-4e45-a73e-70cdf4139a42 11344-928 HUMAN OTC DRUG pyrithione zinc pyrithione zinc SHAMPOO TOPICAL 20160617 OTC MONOGRAPH FINAL part358H Vi-Jon, Inc PYRITHIONE ZINC 10.4 mg/mL N 20181231 11344-942_64476927-2398-4561-b10f-f6a939f0df21 11344-942 HUMAN OTC DRUG Antibacterial Hand Wash Benzalkonium chloride SOAP TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11344-944_dfa35c2a-21b2-47e8-9ab3-90544dd03174 11344-944 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LOTION TOPICAL 20050419 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc ALCOHOL .073 mL/100L N 20181231 11344-951_9cc5b12d-5aaa-4e84-a192-ea2aed8463dc 11344-951 HUMAN OTC DRUG Ethyl Alcohol Ethyl Alcohol GEL TOPICAL 20140908 OTC MONOGRAPH NOT FINAL part333A Vi-Jon, Inc. ALCOHOL 578 mg/mL N 20181231 11344-961_9773d34d-4dde-4ea5-ae85-88028b8e532c 11344-961 HUMAN OTC DRUG Handi Sani ALCOHOL LIQUID TOPICAL 20120402 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 62 mL/100L N 20181231 11344-975_7f3c928c-53fe-4e50-9613-9a630cddbf8b 11344-975 HUMAN OTC DRUG Therapeutic Dandruff Dandruff Shampoo SHAMPOO TOPICAL 20170801 OTC MONOGRAPH FINAL part358H Vi-Jon SALICYLIC ACID 30 mg/mL N 20181231 11344-980_34797270-84ef-4b16-a936-8aad0399d73b 11344-980 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL N 20181231 11344-984_b02b0b3f-868a-41d4-a439-a0ff57e7d260 11344-984 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140314 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 567 mg/mL N 20181231 11344-989_65b9fa6e-b330-44f7-b43e-5ce87c13541c 11344-989 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL N 20181231 11344-999_75dae112-fd26-408c-bc0d-24b156eb6d93 11344-999 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part333A Vi-Jon ALCOHOL 545 mg/mL N 20181231 11383-151_70453c76-7f71-4edb-9c67-3741dc21d1d1 11383-151 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130517 ANDA ANDA091239 Weeks & Leo Co., Inc. IBUPROFEN 200 mg/1 N 20181231 11383-253_471758a2-9b34-29e8-e054-00144ff88e88 11383-253 HUMAN OTC DRUG Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20110325 OTC MONOGRAPH FINAL part358G Weeks & Leo Co., Inc. PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 11383-255_499bdb9f-c236-3293-e054-00144ff8d46c 11383-255 HUMAN OTC DRUG Weeks and Leo Complete Lice Treatment Piperonyl butoxide, Pyrethrum extract KIT TOPICAL 20101028 OTC MONOGRAPH FINAL part358 Weeks & Leo Co., Inc. N 20181231 11383-256_49c8da08-7be9-6b19-e054-00144ff8d46c 11383-256 HUMAN OTC DRUG Weeks and Leo Medicated Vaporizing Steam camphor (synthetic) LIQUID RESPIRATORY (INHALATION) 20111102 OTC MONOGRAPH FINAL part341 Weeks & Leo Co., Inc. CAMPHOR (SYNTHETIC) .623 g/10mL N 20181231 11383-257_5b04f51e-2b48-492b-84b1-22e988d46720 11383-257 HUMAN OTC DRUG Omeprazole Delayed Release Omeprazole TABLET, DELAYED RELEASE ORAL 20110712 NDA NDA022032 Weeks & Leo Co., Inc. OMEPRAZOLE 20 mg/1 N 20181231 11383-258_4b2a349b-93cf-5ef5-e054-00144ff8d46c 11383-258 HUMAN OTC DRUG Weeks and Leo Extra Strength Itch Stopping Diphenhydramine hydrochloride and Zinc acetate CREAM TOPICAL 20140317 OTC MONOGRAPH NOT FINAL part348 Weeks & Leo Co., Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 11401-6994_85aa9e5a-6458-47cf-b587-eaa024deeefb 11401-6994 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20041101 UNAPPROVED MEDICAL GAS Hawaii Home Infusion Associates, Ltd. OXYGEN 99 L/100L E 20171231 11410-001_0efbb216-e584-4e72-965d-76f3c58d5884 11410-001 HUMAN OTC DRUG Proactiv Solution BB Broad Spectrum SPF 15 (Light, Medium, Dark) OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 g/100mL; mg/100mL; mg/100mL E 20171231 11410-003_95ab6912-c84c-444f-8bef-53989eb3ffca 11410-003 HUMAN OTC DRUG X Out Cleansing Wipes For On The Go Blemish Treatment BENZOYL PEROXIDE SWAB TOPICAL 20121231 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.75 mg/1 N 20181231 11410-004_f5afe82f-2f7c-4bbc-801d-f76d70fe9649 11410-004 HUMAN OTC DRUG X Out Daily Body Scrub SALICYLIC ACID LOTION TOPICAL 20121231 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 2 g/100mL E 20171231 11410-005_9fddd898-13d5-4fd9-8dae-8fd83a5bf18a 11410-005 HUMAN OTC DRUG Proactiv Renewing Cleanser Benzoyl Peroxide GEL TOPICAL 20170307 OTC MONOGRAPH FINAL part333D The Proactiv Company, LLC BENZOYL PEROXIDE 2.5 g/100mL N 20181231 11410-006_57eaad0a-1abf-410d-9654-251a75856d84 11410-006 HUMAN OTC DRUG X Out Spot Corrector SULFUR LOTION TOPICAL 20121231 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR 6 g/100mL E 20171231 11410-007_520aa5ba-87ad-4fe3-907f-02f6a586248f 11410-007 HUMAN OTC DRUG X Out Cleansing Body Bar SALICYLIC ACID SOAP TOPICAL 20121231 OTC MONOGRAPH FINAL part333D THE PROACTIV COMPANY LLC SALICYLIC ACID 1 mg/100g N 20181231 11410-008_25d1536e-cc65-4bfb-8ae7-2c891cd7f87a 11410-008 HUMAN OTC DRUG Proactiv plus Skin Purifying Mask SULFUR LOTION TOPICAL 20121231 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR 6 g/100g N 20181231 11410-009_f41965df-b840-406f-b834-23ecbbfe3dea 11410-009 HUMAN OTC DRUG Proactiv plus Pore Targeting Treatment BENZOYL PEROXIDE GEL TOPICAL 20130103 OTC MONOGRAPH FINAL part333D THE PROACTIV COMPANY LLC BENZOYL PEROXIDE 2.5 mg/100mL N 20181231 11410-010_997f3782-24b1-44f1-8e1b-f6e4a9fe25f7 11410-010 HUMAN OTC DRUG Proactiv Plus Complexion Perfecting Hydrator SALICYLIC ACID LOTION TOPICAL 20130301 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .5 g/100mL N 20181231 11410-011_bd282263-a789-4138-9895-8409bce820c9 11410-011 HUMAN OTC DRUG Proactivplus Skin Smoothing Exfoliator BENZOYL PEROXIDE LOTION TOPICAL 20130125 OTC MONOGRAPH FINAL part333D THE PROACTIV COMPANY LLC BENZOYL PEROXIDE 2.5 mg/100mL N 20181231 11410-012_4f2384c6-c784-416f-aeed-88ab4d2f85db 11410-012 HUMAN OTC DRUG Proactiv Emergency Blemish Relief Benzoyl Peroxide CREAM TOPICAL 20130215 OTC MONOGRAPH FINAL part333D THE PROACTIV COMPANY LLC BENZOYL PEROXIDE 5 g/100g N 20181231 11410-014_e177efe4-1fbb-4438-ad74-b9a333507a78 11410-014 HUMAN OTC DRUG Proactiv Blackhead Dissolving SALICYLIC ACID GEL TOPICAL 20170308 OTC MONOGRAPH FINAL part333D The Proactiv Company, LLC SALICYLIC ACID .5 g/100mL N 20181231 11410-015_2f912a62-898c-4a51-a247-11e5dcc21b64 11410-015 HUMAN OTC DRUG Proactiv Skin Purifying Mask SULFUR LOTION TOPICAL 20160308 OTC MONOGRAPH FINAL part333D The Proactiv Company, LLC SULFUR 6 g/100g N 20181231 11410-017_2c979299-2c65-4f8d-95b3-811f6dd10756 11410-017 HUMAN OTC DRUG Proactiv Solution Oil Free Moisture SPF 15 Moisturizer OCTINOXATE and ZINC OXIDE LOTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; ZINC OXIDE 7.5; 3 mg/100mL; mg/100mL E 20171231 11410-018_96e95cb9-894c-4a07-b973-144d97178bac 11410-018 HUMAN OTC DRUG Proactiv Solution Blackhead Dissolving SALICYLIC ACID GEL TOPICAL 20130501 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .5 g/100mL E 20171231 11410-019_cc495788-ebf3-48eb-82e5-ed7e82415985 11410-019 HUMAN OTC DRUG Proactiv Revitalizing Toner Combination Therapy Acne Treatment SALICYLIC ACID LIQUID TOPICAL 20100801 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 2 mg/100mL N 20181231 11410-020_c9ba6915-6cef-441c-a6e8-5b0fccab9020 11410-020 HUMAN OTC DRUG PRINCIPAL SECRET Reclaim Revolutionary Anti-Aging Day SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, and OCTOCRYLENE LOTION TOPICAL 20070817 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 7.5; 5; 2.75 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 11410-021_71b7c1c3-e593-4c2c-a721-1c1c82b0c16d 11410-021 HUMAN OTC DRUG Proactiv Solution Refining Mask Sulfur CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR 6 g/100g N 20181231 11410-027_da51516d-64cb-4474-a783-aa8887a5acd1 11410-027 HUMAN OTC DRUG Proactiv Plus Cleansing Body Bar SALICYLIC ACID SOAP TOPICAL 20130601 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 1 mg/100g E 20171231 11410-028_7b6c94b3-0894-4a12-b733-c967cf4e4d46 11410-028 HUMAN OTC DRUG Proactiv Cover and Heal Duo Concealer Light and Medium SALICYLIC ACID CREAM TOPICAL 20171025 OTC MONOGRAPH FINAL part333D The Proactiv Company, LLC SALICYLIC ACID 1.5 g/100g N 20181231 11410-031_03c5495a-8a72-4913-a06b-27f125830e22 11410-031 HUMAN OTC DRUG X OUT SHINE CONTROL SALICYLIC ACID CREAM TOPICAL 20130819 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .5 mg/mL E 20171231 11410-033_ed3cedb9-04f0-443c-822b-48360e471e39 11410-033 HUMAN OTC DRUG Proactivplus Repairing Concealer (Light/Medium/Tan/Dark) Salicylic Acid CREAM TOPICAL 20150720 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 1.5 g/100g E 20171231 11410-034_b73ef0d7-4118-44cc-b734-bd3ee5df7c61 11410-034 HUMAN OTC DRUG ProactivPlus SPF Protection SPF 15 Octinoxate, Octisalate, and Octocrylene LIQUID TOPICAL 20150720 OTC MONOGRAPH FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE 6; 4; 2 mg/100mL; mg/100mL; mg/100mL N 20181231 11410-035_36575fd0-7268-422f-b7bf-4de5151001d5 11410-035 HUMAN OTC DRUG Proactiv Plus Clarifying Night Salicylic Acid CREAM TOPICAL 20150601 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 1 mg/100mL E 20171231 11410-036_fbec11fc-3f8c-4e57-8117-e3222fa335bb 11410-036 HUMAN OTC DRUG LASHappeal Eye Results with SPF 15 AVOBENZONE, OCTINOXATE, and OXYBENZONE LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; OCTINOXATE; OXYBENZONE 3; 7.5; 5 mg/100mL; mg/100mL; mg/100mL N 20181231 11410-037_added2df-afb9-4907-9fbb-bddb8aa91ab1 11410-037 HUMAN OTC DRUG X Out Shine Control Salicylic Acid GEL TOPICAL 20171012 OTC MONOGRAPH FINAL part333D THE PROACTIV COMPANY LLC SALICYLIC ACID .5 g/100mL N 20191231 11410-039_57d1f6fc-3e53-4033-8536-b6ff41539c6a 11410-039 HUMAN OTC DRUG Proactiv Deep Cleansing Wash Salicylic Acid LOTION/SHAMPOO TOPICAL 20170310 OTC MONOGRAPH FINAL part333D The Proactiv Company, LLC SALICYLIC ACID .02 g/1000mL N 20181231 11410-040_24aca484-b620-4ea0-a23b-aa69855558b1 11410-040 HUMAN OTC DRUG Proactiv Repairing Treatment Benzoyl Peroxide GEL TOPICAL 20170310 OTC MONOGRAPH FINAL part333D The Proactiv Company, LLC BENZOYL PEROXIDE 2.5 mg/100mL N 20181231 11410-041_b0e97d33-a1c9-4d1e-8c78-c2856593a41a 11410-041 HUMAN OTC DRUG Proactiv Cover and Heal Duo Concealer Tan and Dark SALICYLIC ACID CREAM TOPICAL 20171025 OTC MONOGRAPH FINAL part333D The Proactiv Company, LLC SALICYLIC ACID 1.5 g/100g N 20181231 11410-042_d4456f21-74c5-4497-a461-499aa7614cab 11410-042 HUMAN OTC DRUG Proactiv Emergency Blemish Relief Benzoyl Peroxide CREAM TOPICAL 20170309 OTC MONOGRAPH FINAL part333D The Proactiv Company, LLC BENZOYL PEROXIDE 5 g/100g N 20181231 11410-044_9876ae73-e8b9-46a9-838d-ded28cf48f2a 11410-044 HUMAN OTC DRUG Proactiv Repairing Treatment Benzoyl Peroxide LOTION TOPICAL 20090330 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mg/100mL N 20181231 11410-050_b1a109dd-ef6f-45c7-8c7b-572d1888f028 11410-050 HUMAN OTC DRUG PA Plus Advanced Dark Spot Correcting Serum HYDROQUINONE LIQUID TOPICAL 20150611 OTC MONOGRAPH NOT FINAL part358A Guthy-Renker, LLC HYDROQUINONE 20 mg/mL N 20181231 11410-051_ab826b9b-630f-499e-8363-cec3755abf40 11410-051 HUMAN OTC DRUG Proactiv Plus Retexturizing Toner SALICYLIC ACID CREAM TOPICAL 20140215 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 20 mg/mL E 20171231 11410-053_74d6a01c-19d0-4254-8b5d-4b8e76667cbb 11410-053 HUMAN OTC DRUG Proactiv Solution Dark Spot Corrector HYDROQUINONE LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part358A Guthy-Renker LLC HYDROQUINONE 2 g/100mL E 20171231 11410-101_480df48a-dd10-47ed-882b-0a8d517d16fa 11410-101 HUMAN OTC DRUG Proactiv Concealer Plus SULFUR LOTION TOPICAL 19981201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR 8 mg/100mL N 20181231 11410-106_36b1844a-78dd-4869-ae69-0baee89d5c6a 11410-106 HUMAN OTC DRUG Principal Secret Reclaim Radiance Foundation SPF15 Medium Octinoxate and Oxybenzone CREAM TOPICAL 20090910 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OXYBENZONE 7.5; 3 mL/100mL; mL/100mL E 20171231 11410-113_4c3f855e-1bf9-4000-9ec2-ca0487c4fc37 11410-113 HUMAN OTC DRUG Proactiv Solution Deep Cleansing Wash Salicylic Acid LOTION/SHAMPOO TOPICAL 20101001 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .02 g/1000mL N 20181231 11410-117_929c9f5c-2de7-4444-bbf9-513f2b08a481 11410-117 HUMAN OTC DRUG X-Out Wash-In Treatment Benzoyl Peroxide GEL TOPICAL 20110923 OTC MONOGRAPH FINAL part333D THE PROACTIV COMPANY LLC BENZOYL PEROXIDE 8.5 mg/100g N 20181231 11410-121_341bf298-db6a-4fbd-9942-8bc8895ae2ae 11410-121 HUMAN OTC DRUG Principal Secret Reclaim Oil Control Hydrator SPF8 TITANIUM DIOXIDE LOTION TOPICAL 20070912 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC TITANIUM DIOXIDE 4 mL/100mL E 20171231 11410-125_cc9e9305-f0bb-48bb-b259-3712277b245e 11410-125 HUMAN OTC DRUG Principal Secret Reclaim Radiance Foundation SPF15 Light Medium Octinoxate and OXYBENZONE CREAM TOPICAL 20090910 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OXYBENZONE 7.5; 3 mL/100mL; mL/100mL E 20171231 11410-128_eb2630a1-67e6-4792-879c-6bf8961bcdec 11410-128 HUMAN OTC DRUG Proactiv Solution Medicated Cleansing Bar Salicylic Acid SOAP TOPICAL 20110101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 1 g/100g E 20171231 11410-150_6b1d062f-03bd-4aea-b4ce-fc87fdebb063 11410-150 HUMAN OTC DRUG Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAs Octinoxate, Oxybenzone, and Octisalate CREAM TOPICAL 20050426 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OXYBENZONE; OCTISALATE .075; .04; .035 mL/mL; mg/mL; mL/mL N 20181231 11410-160_6b1d062f-03bd-4aea-b4ce-fc87fdebb063 11410-160 HUMAN OTC DRUG Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAs Octinoxate, Oxybenzone, and Octisalate CREAM TOPICAL 20050426 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OXYBENZONE; OCTISALATE .075; .04; .035 mL/mL; mg/mL; mL/mL N 20181231 11410-162_171559ce-39ab-4a1d-bed1-e9383bc1cfa3 11410-162 HUMAN OTC DRUG Proactiv Soothing Scalp Treatment Antidandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20120301 OTC MONOGRAPH FINAL part358H Guthy-Renker LLC PYRITHIONE ZINC 1 mL/100mL E 20171231 11410-201_27ff5bfd-4a86-4a2c-958d-83dfd2edab13 11410-201 HUMAN OTC DRUG Proactiv Clear Zone Body Pads SALICYLIC ACID CLOTH TOPICAL 20050101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .036 g/1 E 20171231 11410-202_ee8e5504-1eb0-4d53-8f52-1c2b4900ef43 11410-202 HUMAN OTC DRUG Proactiv Gentle Formula Clarifying Day SALICYLIC ACID LOTION TOPICAL 20031201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 2 mg/100mL E 20171231 11410-206_a7c36675-5770-4076-8539-662e7855ea34 11410-206 HUMAN OTC DRUG Proactiv Sheer Tint Moisture SPF 15 OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20020201 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 mL/100mL; mL/100mL; mg/100mL N 20181231 11410-207_34b46efa-9e1c-4f50-a255-9342f713d640 11410-207 HUMAN OTC DRUG Proactiv Repairing Benzoyl Peroxide LOTION TOPICAL 20071025 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mg/100mL N 20181231 11410-210_e3e11236-a457-4cbe-95de-d77811ae9255 11410-210 HUMAN OTC DRUG Blemish Buster SULFUR LIQUID TOPICAL 20100511 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR 10 mL/100mL E 20171231 11410-301_01d088e2-abc3-4fb0-aff4-def004150fcb 11410-301 HUMAN OTC DRUG Proactiv Clear Zone SALICYLIC ACID LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 2 mg/100mL E 20171231 11410-302_eba673d7-7661-4d02-bf61-fd7f69b54e67 11410-302 HUMAN OTC DRUG Proactiv Extra Strength Formula Cleanser BENZOYL PEROXIDE CREAM TOPICAL 20031201 OTC MONOGRAPH FINAL part333D THE PROACTIV COMPANY LLC BENZOYL PEROXIDE 7 mg/100mL N 20181231 11410-303_f1388680-1697-4f57-9329-683698dccb6f 11410-303 HUMAN OTC DRUG Proactiv Solution Extra Strength Formula Toner Acne Treatment Salicylic Acid LIQUID TOPICAL 20030101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 2 mg/100mL E 20171231 11410-304_43dbac64-554a-4c07-adf9-f94fe374029a 11410-304 HUMAN OTC DRUG Proactiv Extra Strength Formula BENZOYL PEROXIDE LOTION TOPICAL 20031201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 7 mg/100mL E 20171231 11410-305_16b9f8a1-ce62-4043-8330-c37de4cc1fc8 11410-305 HUMAN OTC DRUG Proactiv Gentle Formula Clearifying Night SALICYLIC ACID LOTION TOPICAL 20080301 OTC MONOGRAPH FINAL part333D THE PROACTIV COMPANY LLC SALICYLIC ACID 1 mg/100mL N 20181231 11410-309_af3df535-280a-45fc-94d2-670e577aed5b 11410-309 HUMAN OTC DRUG Proactiv Herbal Conditioning Treatment PYRITHIONE ZINC CREAM TOPICAL 19991201 OTC MONOGRAPH FINAL part358A Guthy-Renker LLC PYRITHIONE ZINC 3 mg/1000mL E 20171231 11410-401_3219fe95-09ae-4a1d-b6af-a330390000a7 11410-401 HUMAN OTC DRUG Proactiv Advanced Blemish Treatment Benzoyl Peroxide CREAM TOPICAL 19990101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC. BENZOYL PEROXIDE .06 g/g N 20181231 11410-402_285a5386-2e90-48da-9b7e-bcd2e874715a 11410-402 HUMAN OTC DRUG Proactiv Clarifying Night Acne Treatment Salicylic Acid CREAM TOPICAL 20020101 OTC MONOGRAPH FINAL part333D THE PROACTIV COMPANY LLC SALICYLIC ACID 1 mg/100mL N 20181231 11410-405_f93d0550-9d49-47d8-90c8-43e5d66ebfdd 11410-405 HUMAN OTC DRUG Proactiv Solution Daily Protection Plus Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 5; 7.5; 5; 5 mg/.1g; mg/.1g; mL/.1g; mg/.1g; mg/.1g E 20171231 11410-406_e8e54be3-acfd-450c-9e67-415c4f05df18 11410-406 HUMAN OTC DRUG Proactiv Soothing Scalp Treatment Antidandruff PYRITHIONE ZINC SHAMPOO TOPICAL 19981201 OTC MONOGRAPH FINAL part358A Guthy-Renker LLC PYRITHIONE ZINC 1 mg/100mL E 20171231 11410-407_4f19248d-ab3a-4ff8-bcd7-c939257e71aa 11410-407 HUMAN OTC DRUG Proactiv Pore Cleansing System SALICYLIC ACID SOLUTION TOPICAL 20050201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 5 mg/1000mL E 20171231 11410-408_cf9dca83-cfdf-481a-9148-a68856529718 11410-408 HUMAN OTC DRUG Proactiv Skin Lightening HYDROQUINONE LOTION TOPICAL 19980101 OTC MONOGRAPH FINAL part358A Guthy-Renker LLC HYDROQUINONE 2 mg/100mL E 20171231 11410-409_e4ceb862-d396-499d-849c-280658f58890 11410-409 HUMAN OTC DRUG Proactiv Renewing Cleanser Benzoyl Peroxide CREAM TOPICAL 20090101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE .25 g/1000mL N 20181231 11410-410_6f57ecff-79fa-4c17-89c4-03f6acbe2479 11410-410 HUMAN OTC DRUG Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAs Octinoxate, Oxybenzone, and Octisalate CREAM TOPICAL 20080508 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OXYBENZONE; OCTISALATE .075; .04; .035 mL/mL; mg/mL; mL/mL N 20181231 11410-411_55fd49ea-635d-41e4-b557-83fb894b200b 11410-411 HUMAN OTC DRUG Dr. Evans Oil-Free DEFENSE DAY TINTED MOISTURIZER SPF 55 Homosalate, Octisalate, Oxybenzone, Avobenzone, Octocrylene LIQUID TOPICAL 20110204 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker, LLC. HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 100; 50; 60; 30; 20 uL/mL; uL/mL; uL/mL; uL/mL; uL/mL N 20181231 11410-412_668321a0-1eb9-4843-abb7-f2856225e829 11410-412 HUMAN OTC DRUG Jane Seymour Oil-Free Tinted Moisturizer with SPF 55 Oxybenzone, Octocrylene, Octisalate, Avobenzone, Homosalate LIQUID TOPICAL 20110204 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker, LLC. OXYBENZONE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE 60; 20; 50; 30; 100 uL/mL; uL/mL; uL/mL; uL/mL; uL/mL N 20181231 11410-413_926f5193-628c-4adf-a14b-b90f1bdf101c 11410-413 HUMAN OTC DRUG Natural Advantage SPF 15 All Day Moisture with AHAs octinoxate, oxybenzone, octisalate CREAM TOPICAL 20091102 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OXYBENZONE; OCTISALATE 75; 40; 35 uL/mL; uL/mL; uL/mL N 20181231 11410-420_6f57ecff-79fa-4c17-89c4-03f6acbe2479 11410-420 HUMAN OTC DRUG Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAs Octinoxate, Oxybenzone, and Octisalate CREAM TOPICAL 20080508 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OXYBENZONE; OCTISALATE .075; .04; .035 mL/mL; mg/mL; mL/mL N 20181231 11410-501_26490dbf-edb8-4ad9-a70e-8f2b0abe0ba0 11410-501 HUMAN OTC DRUG Proactiv Gentle Formula Clarifying Cleanser Salicylic Acid CREAM TOPICAL 20030101 OTC MONOGRAPH FINAL part333D THE PROACTIV COMPANY LLC SALICYLIC ACID .02 g/1000mL N 20181231 11410-503_2bd4498b-12e6-47f7-9344-c44db3d9143a 11410-503 HUMAN OTC DRUG Daily Body Moisture Hydrating Complex SPF8 OCTINOXATE and OXYBENZONE LOTION TOPICAL 20050802 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OXYBENZONE 7.5; 1 mL/100mL; mL/100mL N 20181231 11410-507_c57ce3d5-bd2a-4869-ab41-d4238d4421fa 11410-507 HUMAN OTC DRUG Proactiv Refining Mask Sulfur CREAM TOPICAL 19981201 OTC MONOGRAPH FINAL part333D THE PROACTIV COMPANY LLC SULFUR .06 g/g N 20181231 11410-509_cb33c559-2256-4411-a299-53eaaf1f8cb9 11410-509 HUMAN OTC DRUG Proactiv Deep Cleansing Wash Salicylic Acid CREAM TOPICAL 20050101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .02 g/1000mL N 20181231 11410-541_48c30b3c-7c9c-4371-a3b4-1443d9269a4d 11410-541 HUMAN OTC DRUG Principal Secret Advanced with Hydrospheres Continuous Moisture SPF8 Octinoxate and Octisalate CREAM TOPICAL 20020510 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE 7.5; 1 mg/.1g; mg/.1g E 20171231 11410-601_b87657e2-50b7-4401-93b0-def5ee2f2cb1 11410-601 HUMAN OTC DRUG Proactiv Solution Daily Protection Plus Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20110607 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 5; 7.5; 5; 5 mg/100g; mL/100g; mL/100g; mL/100g; mg/100g E 20171231 11410-602_17cf5607-dd7f-4375-a698-b145cfcac43b 11410-602 HUMAN OTC DRUG Proactiv Solution Anti-Itch Scalp HYDROCORTISONE LIQUID TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part348 Guthy-Renker LLC. HYDROCORTISONE .28 mg/100mL E 20171231 11410-603_d7590191-9bcd-4986-9ee5-5e83e7de21e0 11410-603 HUMAN OTC DRUG Proactiv SPF 15 Moisturizer OCTINOXATE and ZINC OXIDE LOTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 THE PROACTIV COMPANY LLC OCTINOXATE; ZINC OXIDE 7.5; 3 mg/100mL; mg/100mL N 20181231 11410-610_33d789b9-0d60-46c9-8c42-eac7da1c7415 11410-610 HUMAN OTC DRUG Proactiv Solution Purifying Botanical Peel SALICYLIC ACID GEL TOPICAL 20120210 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .5 mg/100mL E 20171231 11410-611_58b711c9-e78c-4f3f-81f9-9dbbb08edc14 11410-611 HUMAN OTC DRUG Proactiv Solution Advanced Daily Oil Control SALICYLIC ACID LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID .5 mg/100mL E 20171231 11410-694_4558c407-3ae3-4951-9123-7db29a4abe1d 11410-694 HUMAN OTC DRUG Sheer Cover Nourishing Moisturizer SPF 15 OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20061201 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 mL/100mL; mg/100mL; mg/100mL E 20171231 11410-701_a507069c-33c6-437d-a26a-b2913d5ebe6c 11410-701 HUMAN OTC DRUG Proactiv Mild Exfoliating Peel SALICYLIC ACID GEL TOPICAL 20041201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SALICYLIC ACID 5 mg/1000mL E 20171231 11410-711_85277c02-6748-42c9-b769-9ade509eced9 11410-711 HUMAN OTC DRUG Proactiv Sheer Tint Moisture SPF 15 OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20081101 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 mL/100mL; mL/100mL; mg/100mL N 20181231 11410-749_0e620513-c4d8-4d0f-9eb6-350f8ebafe37 11410-749 HUMAN OTC DRUG In An Instant Daily Tinted Moisturizer SPF 15 Octinoxate, Octisalate, and Avobenzone CREAM TOPICAL 20071025 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC. OCTINOXATE; OCTISALATE; AVOBENZONE .075; .05; .02 mL/mL; mL/mL; mg/mL E 20171231 11410-812_e0690be7-ad05-4f72-95db-6548f59ef567 11410-812 HUMAN OTC DRUG Proactiv Clear Purifying Mask SULFUR GEL TOPICAL 20080201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC SULFUR 6 mg/100mL N 20181231 11410-839_9d42fea4-9151-4bf3-b5bd-be07b1c7c242 11410-839 HUMAN OTC DRUG Ice Elements SPF 15 Moisturizer Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100224 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE .075; .05; .03 mL/mL; mL/mL; mg/mL E 20171231 11410-901_7bd6ba71-47fc-4858-9bcb-52137f624920 11410-901 HUMAN OTC DRUG Proactiv Solution Renewing Cleanser Benzoyl Peroxide LOTION TOPICAL 20120201 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mL/100mL N 20181231 11410-904_854bbec9-d12f-46c0-9ae3-61ea35c40325 11410-904 HUMAN OTC DRUG Proactiv Solution Renewing Cleanser Benzoyl Peroxide GEL TOPICAL 20111021 OTC MONOGRAPH FINAL part333D The Proactiv Company, LLC BENZOYL PEROXIDE 2.5 mg/100mL N 20181231 11410-906_e8730d62-0726-4a4f-bd4a-074a016c174d 11410-906 HUMAN OTC DRUG Proactiv Solution Repairing Treatment Benzoyl Peroxide GEL TOPICAL 20111101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mL/100mL N 20181231 11410-920_ba5bdb57-0bbc-4414-888b-618707484b64 11410-920 HUMAN OTC DRUG Proactiv Repairing Treatment Benzoyl Peroxide LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mg/100mL N 20181231 11410-923_c894dc26-6668-43c8-a24a-b283dd1d9887 11410-923 HUMAN OTC DRUG Proactiv Renewing Cleanser Benzoyl Peroxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE .025 g/1000mL N 20181231 11410-927_c894dc26-6668-43c8-a24a-b283dd1d9887 11410-927 HUMAN OTC DRUG Proactiv Renewing Cleanser Benzoyl Peroxide CREAM TOPICAL 20100801 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE .025 g/1000mL N 20181231 11410-955_5adcadee-dff3-44b7-8b20-8cc106824608 11410-955 HUMAN OTC DRUG Proactiv Solution Repairing Treatment Benzoyl Peroxide GEL TOPICAL 20131101 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 2.5 mg/100mL E 20171231 11410-956_0c886303-dcf9-48f5-970c-83fd62d1a0aa 11410-956 HUMAN OTC DRUG Proactiv MD Adapalene Acne Treatment Adapalene GEL TOPICAL 20170327 NDA AUTHORIZED GENERIC NDA020380 The Proactiv Company, LLC ADAPALENE .1 g/100g N 20181231 11410-957_b36da214-9992-4880-b152-c6ae6f2b025f 11410-957 HUMAN OTC DRUG Proactiv MD Daily Oil Control SPF 30 Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20170522 OTC MONOGRAPH FINAL part352 The Proactiv Company, LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 7 mg/100mL; mg/100mL; mg/100mL N 20181231 11419-001_513a6f8d-e727-4adc-acbc-cfbb97d53bba 11419-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19540101 NDA NDA205865 SheSam, Inc. OXYGEN 995 mL/L N 20181231 11429-1001_27a86598-ccd4-4e1e-a77e-0fe61eae9cf6 11429-1001 HUMAN OTC DRUG FoamFresh Alco-Free Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140416 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 11429-1002_5a798857-9e85-41e1-97c4-700cf373b5aa 11429-1002 HUMAN OTC DRUG FoamFresh E-2 Sanitizer Cleanser BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140226 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11429-1003_6c9b2995-c1df-4483-8eb7-58122b063b04 11429-1003 HUMAN OTC DRUG Alco Hand Sanitizer ALCOHOL GEL TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company ALCOHOL 70 mL/100mL N 20181231 11429-1004_6e3c30ad-bb53-4e4c-9bcd-00d32179d289 11429-1004 HUMAN OTC DRUG FoamFresh Alco-Foam Hand Sanitizer Alcohol LIQUID TOPICAL 20140331 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company ALCOHOL 62 mL/100mL N 20181231 11429-1005_6dbf5d89-79cf-41c6-89af-34148c54f21b 11429-1005 HUMAN OTC DRUG FoamFresh Antibacterial Hand Wash CHLOROXYLENOL LIQUID TOPICAL 20120928 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company CHLOROXYLENOL 2.5 mg/mL N 20181231 11429-1006_f36633fe-f295-438e-a885-7e1286411f64 11429-1006 HUMAN OTC DRUG Lemon Drop Gentle Antiseptic CHLOROXYLENOL LIQUID TOPICAL 20140416 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company CHLOROXYLENOL 3 mg/mL N 20181231 11429-1007_cacb43f0-2b35-4cdf-94e2-234dfb799106 11429-1007 HUMAN OTC DRUG Derma 1 Healthcare Hand Wash CHLOROXYLENOL LIQUID TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company CHLOROXYLENOL 4 mg/mL N 20181231 11429-1008_e56c7abc-8858-4fb6-a7d6-a4e2ec6a3966 11429-1008 HUMAN OTC DRUG FoamFresh Healthcare Hand Wash CHLOROXYLENOL LIQUID TOPICAL 20140418 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company CHLOROXYLENOL 7.5 mg/mL N 20181231 11429-1009_a30a64c2-0f5b-4be9-a571-d85f851327cb 11429-1009 HUMAN OTC DRUG Pink Antibacterial CHLOROXYLENOL LIQUID TOPICAL 20140409 OTC MONOGRAPH NOT FINAL part333A Woodbine Products Company CHLOROXYLENOL 3 mg/mL N 20181231 11444-001_bff49ae3-b1f2-4fbd-be5e-9cfabd144f6c 11444-001 HUMAN OTC DRUG Absorbine Jr. Menthol LIQUID TOPICAL 19010101 20180228 OTC MONOGRAPH NOT FINAL part348 W. F. Young, Inc. MENTHOL .0127 g/mL E 20171231 11446-188_302cae91-dd09-4d47-989d-702f00d31294 11446-188 HUMAN OTC DRUG Easy Menthol PATCH TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 Wong’s Pharmaceutical International MENTHOL 4 g/1 N 20181231 11489-056_bf5c3ef3-12ae-4270-8c6c-b5a9d75b7d78 11489-056 HUMAN OTC DRUG Botanics Daily Hand Therapy Sunscreen SPF 10 Octinoxate and Avobenzone CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 BCM Ltd OCTINOXATE; AVOBENZONE 3; 1.5 mL/75mL; mL/75mL E 20171231 11489-057_2d9d5ee4-d733-40c9-a4c2-2d6107135a4d 11489-057 HUMAN OTC DRUG BOTANICS FACE RENEWAL SUNSCREEN SPF 15 OCTINOXATE AND AVOBENZONE CREAM TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part352 BCM Ltd OCTINOXATE; AVOBENZONE 3; 1.5 mL/50mL; mL/50mL E 20171231 11489-059_43066658-0de0-47e2-95e7-b540d8344c74 11489-059 HUMAN OTC DRUG BOTANICS FACE LIFT FIRMING SUNSCREEN SPF 10 OCTINOXATE, AVOBENZONE AND OCTISALATE CREAM TOPICAL 20100222 OTC MONOGRAPH NOT FINAL part352 BCM Ltd OCTINOXATE; AVOBENZONE; OCTISALATE 3.75; 1.5; 1.25 mL/50mL; mL/50mL; mL/50mL E 20171231 11489-060_873f9dcd-b423-41d7-8349-2d32cc831498 11489-060 HUMAN OTC DRUG Botanics Complexion Refining Day Moisture Sunscreen SPF 12 Octinoxate and Avobenzone LOTION TOPICAL 20100127 OTC MONOGRAPH NOT FINAL part352 BCM Ltd OCTINOXATE; AVOBENZONE 3.75; 2.25 mL/75mL; mL/75mL E 20171231 11489-061_4f934e55-0d31-4901-8c29-c779903e500a 11489-061 HUMAN OTC DRUG No7 Advanced Hydration Day Sunscreen SPF 12 Octinoxate and Avobenzone CREAM TOPICAL 20091203 OTC MONOGRAPH NOT FINAL part352 BCM Ltd OCTINOXATE; AVOBENZONE 2.5; 1.5 mL/50mL; mL/50mL E 20171231 11489-062_9c2f3b99-32b6-4dd9-9faf-d4c7d8a7f83c 11489-062 HUMAN OTC DRUG No7 Time Resisting Day Sunscreen SPF 12 Octinoxate and Avobenzone CREAM TOPICAL 20091208 OTC MONOGRAPH NOT FINAL part352 BCM Ltd OCTINOXATE; AVOBENZONE 2.5; 1.25 mL/50mL; mL/50mL E 20171231 11489-064_70998b82-8fab-4224-b366-065e62fe4a5c 11489-064 HUMAN OTC DRUG No7 Lifting and Firming Day Sunscreen SPF 8 Octinoxate, Avobenzone and Octisalate EMULSION TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 BCM Ltd OCTINOXATE; AVOBENZONE; OCTISALATE 3.75; 1.5; 1 mL/50mL; mL/50mL; mL/50mL E 20171231 11489-066_d9fb9ec5-37a2-4be3-a8fb-6864bb234f9f 11489-066 HUMAN OTC DRUG BOTANICS TRIPLE ACTION DAY MOISTURE SUNSCREEN SPF 15 OCTINOXATE AND AVOBENZONE CREAM TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part352 BCM Ltd OCTINOXATE; AVOBENZONE 2.25; 1.5 mL/50mL; mL/50mL E 20171231 11489-067_66b3c3d3-ed07-41d1-aa58-9e09da24bdd9 11489-067 HUMAN OTC DRUG No7 Protect and Perfect Day Sunscreen SPF 15 Avobenzone , Octinoxate and Octisalate EMULSION TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 BCM Ltd OCTINOXATE; AVOBENZONE; OCTISALATE 3; 1.5; 1.25 mL/50mL; mL/50mL; mL/50mL E 20171231 11489-068_c3d2f3c2-c762-4d6d-9f32-5e6273666193 11489-068 HUMAN OTC DRUG No7 Protect and Perfect Hand Sunscreen SPF 15 Octinoxate, Avobenzone and Octisalate CREAM TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 BCM Ltd OCTINOXATE; AVOBENZONE; OCTISALATE 5.625; 2.25; 1.5 mL/75mL; mL/75mL; mL/75mL E 20171231 11489-069_eff82fba-618b-4299-8245-919d41d08967 11489-069 HUMAN OTC DRUG No7 Rebalancing Day Fluid Sunscreen SPF 15 Octinoxate and Avobenzone and Ensulizole LOTION TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 BCM Ltd OCTINOXATE; AVOBENZONE; ENSULIZOLE 6; 2; 2 mL/100mL; mL/100mL; mL/100mL E 20171231 11489-070_da043113-ae2c-4cc6-8fe9-bcba6baa3df5 11489-070 HUMAN OTC DRUG No7 Beautiful Skin Day Normal Oily Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 mL/50mL; mL/50mL; mL/50mL N 20181231 11489-071_01be9574-b61d-4da4-99e4-14197eb09833 11489-071 HUMAN OTC DRUG No7 Beautiful Skin Day Normal Dry Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 mL/50mL; mL/50mL; mL/50mL N 20181231 11489-072_a51c6e2a-b38f-4c79-bae5-ffb00e2b55d1 11489-072 HUMAN OTC DRUG No7 Beautiful Skin Day Dry Very Dry Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 mL/50mL; mL/50mL; mL/50mL N 20181231 11489-073_cbfbd805-dfe9-4fa5-9e52-ad57341b9a4b 11489-073 HUMAN OTC DRUG No7 Beautiful Skin Oil Free Skin Protector All Skin Types SPF 25 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.75; 3.25 mL/50mL; mL/50mL; mL/50mL N 20181231 11489-074_6d03e6c6-327b-406f-9093-656a9d9ce4e9 11489-074 HUMAN OTC DRUG No7 Protect and Perfect Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3; 1.25 mL/50mL; mL/50mL; mL/50mL E 20171231 11489-075_45a761e9-5754-4011-b8c3-4f31fe74614c 11489-075 HUMAN OTC DRUG No7 Lift and Luminate Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octocrylene CREAM TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5; 2.5; .5 mL/50mL; mL/50mL; mL/50mL E 20171231 11489-076_adc57bae-ddcd-41e2-8319-a1ab88f869c0 11489-076 HUMAN OTC DRUG No7 Protect and Perfect Hand Cream Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTISALATE 2.25; 5.625; 1.5 mL/75mL; mL/75mL; mL/75mL N 20181231 11489-077_0fbaa8b8-2137-423e-8f59-e2057d75e2cb 11489-077 HUMAN OTC DRUG No7 Protect and Perfect Intense Day Cream Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-078_b4aa84e3-5ad6-44a4-83ed-f9784a63c608 11489-078 HUMAN OTC DRUG No7 Restore and Renew Day Sunscreen Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20121210 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g N 20181231 11489-079_15261ca5-1211-4dc5-a35b-47057c94c5c1 11489-079 HUMAN OTC DRUG No7 Men Protect and Perfect Intense Moisturiser Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20121210 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2 g/50g; g/50g; g/50g N 20181231 11489-080_d9325225-4f19-4cf5-92d3-f4cddcb7127c 11489-080 HUMAN OTC DRUG Botanics Hydrating Day All Bright Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g N 20181231 11489-081_cd9a29cc-a2d2-4eed-8da7-952777c2e94a 11489-081 HUMAN OTC DRUG Botanics Skin Calming Day Ultra Calm Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g E 20171231 11489-082_edb33106-2fa3-4db8-afd1-f8e3ae50606c 11489-082 HUMAN OTC DRUG Botanics Mattifying Day All Bright Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g N 20181231 11489-083_17993d11-7f25-46e9-8b3c-86c222ccb4a8 11489-083 HUMAN OTC DRUG Botanics Protecting Day Age Defense Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g N 20181231 11489-084_7f28428c-242d-4f93-98c1-d291185d5576 11489-084 HUMAN OTC DRUG Botanics Triple Age Renewal Day All Bright Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g N 20181231 11489-085_86082a4e-9654-40a2-8770-049bddd9703a 11489-085 HUMAN OTC DRUG No7 Protect and Perfect Intense Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20140926 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-086_6aab8777-94fa-4268-858b-65f138a4b34e 11489-086 HUMAN OTC DRUG No7 Protect and Perfect Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20140926 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-087_bbdd3150-7f98-4dc6-b231-1c483292084a 11489-087 HUMAN OTC DRUG No7 Lift and Luminite Day Cream SPF 15 Avobenzone,Octinoxate, Octocrylene CREAM TOPICAL 20140926 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5; 2.5; .5 g/50g; g/50g; g/50g E 20171231 11489-088_22646bda-8442-4bab-82cd-751ad4db46e4 11489-088 HUMAN OTC DRUG No7 Protect and Perfect Intense Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20140804 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-089_1a4b146c-ef68-4f11-809e-c3894128450f 11489-089 HUMAN OTC DRUG Botanics Hydrating Day All Bright Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g N 20181231 11489-090_09f902a8-396e-4174-ab58-1db608b1a030 11489-090 HUMAN OTC DRUG Botanics Protecting Day Age Defense Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g N 20181231 11489-091_601c6310-8526-4140-bc79-05046f1cccd9 11489-091 HUMAN OTC DRUG No7 Lift and Luminate Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20151010 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-092_0560dcd3-7eab-4f3c-a89e-3a6bfd920e99 11489-092 HUMAN OTC DRUG No7 Protect and Perfect Intense Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20150707 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-093_978eb2f0-0c94-4a17-a481-c2af89423c8e 11489-093 HUMAN OTC DRUG Botanics All Bright Hydrating Day Cream Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g N 20181231 11489-094_8a3e6d1e-ddab-4872-bebf-fffe8fb1c3d1 11489-094 HUMAN OTC DRUG Botanics Radiant Youth Protecting Day Cream Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g N 20181231 11489-095_dd69d898-2c37-465f-a5ca-a83625f70a7c 11489-095 HUMAN OTC DRUG Botanics Triple Age Renewal Day Cream Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g N 20181231 11489-096_ed0ca160-8291-468b-a3ce-fd053d40cb17 11489-096 HUMAN OTC DRUG Botanics Shine Away Mattifying Day Cream Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.5; 2.5 g/50g; g/50g; g/50g N 20181231 11489-097_a5ba8a48-8726-4cc1-a0ea-6ed01dc98430 11489-097 HUMAN OTC DRUG No7 Early Defence Day Cream Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 3.75; 2.5 g/g; g/g; g/g N 20181231 11489-098_6c5e7d11-e5ad-4580-89ee-06a5f171b76b 11489-098 HUMAN OTC DRUG No7 Restore and Renew Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20160316 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-099_c2f43dc2-1b23-4a6e-959e-0f979a3b0661 11489-099 HUMAN OTC DRUG No7 Lift and Luminate Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20151010 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-100_f08dca2f-bbd2-43ec-a0c0-df99624404ac 11489-100 HUMAN OTC DRUG No7 Protect and Perfect Intense Advanced Day Cream SPF 30 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 3.75; 2.5 g/50g; g/50g; g/50g N 20181231 11489-101_736671f1-9db6-44f4-836b-e6add9401257 11489-101 HUMAN OTC DRUG No7 Protect and Perfect Intense Advanced Day Cream SPF 30 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 3.75; 2.5 g/50g; g/50g; g/50g N 20181231 11489-102_0f2cac13-af2c-4b8c-bbaf-01363c67183b 11489-102 HUMAN OTC DRUG No7 Early Defence Day Cream Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20160922 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 3.75; 2.5 g/g; g/g; g/g N 20181231 11489-103_0e4c9682-4f3c-491e-b28d-9c72003a9dd0 11489-103 HUMAN OTC DRUG No7 Lift and Luminate Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20160922 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-104_8f19cd91-f6c0-4d43-8dec-b10d1523e497 11489-104 HUMAN OTC DRUG No7 Beautiful Skin Day Cream Normal Dry SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-105_12be8490-c3a5-48e0-a249-252f784ded19 11489-105 HUMAN OTC DRUG No7 Protect and Perfect Intense Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-107_62ba41ff-e7c6-45ae-8a94-fbe5f636aa81 11489-107 HUMAN OTC DRUG No7 Protect and Perfect Intense Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-108_30f934c7-e45f-43ca-b8b2-d316ad9fceb7 11489-108 HUMAN OTC DRUG No7 Men Protect and Perfect Intense Advanced Day Moisturiser SPF 30 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20160922 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 3.75; 4 g/50g; g/50g; g/50g N 20181231 11489-109_09e7a904-c544-4158-832b-582ec7ffba73 11489-109 HUMAN OTC DRUG No7 Restore and Renew Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20160316 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-111_2b0d923a-8cd5-45c4-8932-7a13f44dd7c9 11489-111 HUMAN OTC DRUG No7 Beautiful Skin Day Cream Normal Dry SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20161011 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-112_88520cb3-8fb6-4e5e-aa96-e548683a1552 11489-112 HUMAN OTC DRUG YourGoodSkin SPF 30 Anti-oxidant Day Sunscreen Broad Spectrum SPF 30 Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20171016 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2.25; .375; 3.75; 5.625 g/75g; g/75g; g/75g; g/75g N 20181231 11489-113_7df59422-ba03-4f4d-a8d6-5d7bd7fe934d 11489-113 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Day Cream SPF 30 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20161205 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 3.75; 2.5 g/50g; g/50g; g/50g N 20181231 11489-114_8e429c8f-b73f-4088-abbf-ca95185c55b5 11489-114 HUMAN OTC DRUG No7 Restore and Renew Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20160316 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-115_eae4c50f-a8c5-4e92-848f-ccfa83ad4a20 11489-115 HUMAN OTC DRUG No7 Restore and Renew Day Cream SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20170428 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g N 20181231 11489-116_068f7ff7-f77c-4324-bac0-3eaa196b7735 11489-116 HUMAN OTC DRUG No7 Beautiful Skin Day Cream Normal Dry SPF 15 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20170707 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE .75; 1; .5 g/25g; g/25g; g/25g N 20181231 11489-117_de4a24a8-9071-46ac-a5fd-8e37e76d6718 11489-117 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Day Cream SPF 30 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20170707 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE .75; 1.875; 1.25 g/25g; g/25g; g/25g N 20181231 11489-118_90eb3fe4-dddb-46b4-b320-4f536bde6757 11489-118 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Day Cream SPF 30 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20170707 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE .75; 1.875; 1.25 g/25g; g/25g; g/25g N 20181231 11489-119_059e4268-0c00-45ae-bfd5-725688689933 11489-119 HUMAN OTC DRUG No7 Protect and Perfect Intense Advanced Day Cream SPF 30 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20170707 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE .75; 1.875; 1.25 g/25g; g/25g; g/25g N 20181231 11489-121_10481e45-b578-4459-89c0-1b333ef20d40 11489-121 HUMAN OTC DRUG No7 Protect and Perfect Intense Advanced Day Cream SPF 30 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20170707 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 3.75; 2.5 g/50g; g/50g; g/50g N 20181231 11489-122_925dc9d2-1c1c-4911-9b52-4fa59d1ef2c7 11489-122 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Day Cream SPF 30 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20170707 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 3.75; 2.5 g/25g; g/25g; g/25g N 20181231 11489-123_a032773f-a988-4ba4-9745-dc524d0c9373 11489-123 HUMAN OTC DRUG No7 Protect and Perfect Intense Advanced Day Cream SPF 30 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20170707 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE .75; 1.875; 1.25 g/25g; g/25g; g/25g N 20181231 11489-124_3c921d88-520f-4dcc-afb6-9e305dae3285 11489-124 HUMAN OTC DRUG No7 Protect and Perfect Intense Advanced Day Cream SPF 30 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20170707 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 3.75; 2.5 g/25g; g/25g; g/25g N 20181231 11489-125_8eb3b637-1772-47a4-b326-a1754c523e94 11489-125 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Day Cream SPF 30 Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 3.75; 2.5 g/50g; g/50g; g/50g N 20181231 11489-126_b6baa02d-1e82-4ae7-9113-4f0f5ae4bb47 11489-126 HUMAN OTC DRUG No7 Early Defence Day Cream Avobenzone,Octisalate, Octocrylene CREAM TOPICAL 20170808 OTC MONOGRAPH NOT FINAL part352 BCM Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 3.75; 2.5 g/g; g/g; g/g N 20181231 11509-0001_7cdaa0d7-dc13-4a92-8a28-47bde51c6ed6 11509-0001 HUMAN OTC DRUG Cepacol Sore Throat Regular Strength menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated MENTHOL 3 mg/1 E 20171231 11509-0003_0062f266-1a0a-46e7-8aa6-8cfcbf2fb3f3 11509-0003 HUMAN OTC DRUG Cepacol Sore Throat from Post Nasal Drip menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated MENTHOL 4.5 mg/1 E 20171231 11509-0011_38509b77-ebd1-47f5-8349-62f2fc92c33a 11509-0011 HUMAN OTC DRUG Cepacol Sore Throat Maximum Numbing Cherry benzocaine and menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 E 20171231 11509-0012_38509b77-ebd1-47f5-8349-62f2fc92c33a 11509-0012 HUMAN OTC DRUG Cepacol Sore Throat Maximum Numbing Honey Lemon benzocaine and menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; MENTHOL 15; 2.6 mg/1; mg/1 E 20171231 11509-0013_38509b77-ebd1-47f5-8349-62f2fc92c33a 11509-0013 HUMAN OTC DRUG Cepacol Sore Throat Maximum Numbing Citrus benzocaine and menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; MENTHOL 15; 2.1 mg/1; mg/1 E 20171231 11509-0014_38509b77-ebd1-47f5-8349-62f2fc92c33a 11509-0014 HUMAN OTC DRUG Cepacol Sore Throat Maximum Numbing Sugar Free Cherry benzocaine and menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; MENTHOL 15; 4 mg/1; mg/1 E 20171231 11509-0020_07b57a6c-4171-490b-a4eb-c61d527c377a 11509-0020 HUMAN OTC DRUG Cepacol Sore Throat Plus Cough benzocaine and dextromethorphan hydrobromide LOZENGE ORAL 20050728 OTC MONOGRAPH FINAL part341 Combe Incorporated BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 E 20171231 11509-0025_afa3437a-b785-4ca0-98e7-0323692d7efd 11509-0025 HUMAN OTC DRUG Cepacol Fizzlers benzocaine TABLET, ORALLY DISINTEGRATING ORAL 20090901 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE 6 mg/1 E 20171231 11509-0031_38509b77-ebd1-47f5-8349-62f2fc92c33a 11509-0031 HUMAN OTC DRUG Cepacol Sore Throat Maximum Numbing Sugar Free Cherry benzocaine and menthol LOZENGE ORAL 20030728 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; MENTHOL 15; 4 mg/1; mg/1 E 20171231 11509-0040_0ec7eaee-d45c-4d05-84e1-d8fb5276511b 11509-0040 HUMAN OTC DRUG Cepacol Sore Throat Plus Coating benzocaine and pectin LOZENGE ORAL 20060831 OTC MONOGRAPH NOT FINAL part356 Combe Incorporated BENZOCAINE; PECTIN 15; 5 mg/1; mg/1 E 20171231 11509-0325_c5f17115-49ef-495f-81be-24edfe190934 11509-0325 HUMAN OTC DRUG Scalpicin Anti Itch Medication salicylic acid LIQUID TOPICAL 19940615 OTC MONOGRAPH FINAL part358 Combe Incorporated SALICYLIC ACID 30 mg/g E 20171231 11509-0360_677f7070-e6b4-4259-9c47-c1458dbb09b6 11509-0360 HUMAN OTC DRUG Vagisil Anti Itch Original Strength Benzocaine and Resorcinol CREAM TOPICAL 19740801 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated BENZOCAINE; RESORCINOL 50; 20 mg/g; mg/g E 20171231 11509-0372_677f7070-e6b4-4259-9c47-c1458dbb09b6 11509-0372 HUMAN OTC DRUG Vagisil Anti Itch Maximum Strength Benzocaine and Resorcinol CREAM TOPICAL 19740801 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated BENZOCAINE; RESORCINOL 200; 30 mg/g; mg/g E 20171231 11509-0375_a8500c39-5a01-4bcc-a1de-e5ac6875b345 11509-0375 HUMAN OTC DRUG Vagisil Medicated Wipes pramoxine hydrochloride CLOTH TOPICAL 20050628 OTC MONOGRAPH NOT FINAL part347 Combe Incorporated PRAMOXINE HYDROCHLORIDE 10 mg/g E 20171231 11509-0376_a8500c39-5a01-4bcc-a1de-e5ac6875b345 11509-0376 HUMAN OTC DRUG Vagisil Medicated Wipes pramoxine hydrochloride CLOTH TOPICAL 20050628 OTC MONOGRAPH NOT FINAL part347 Combe Incorporated PRAMOXINE HYDROCHLORIDE 10 mg/g E 20171231 11509-0381_1d87a0ce-43d3-4422-802c-593004d25c94 11509-0381 HUMAN OTC DRUG Lanacane Maximum Strength Anti Bacterial First Aid Spray benzocaine and benzethonium chloride SPRAY TOPICAL 19931227 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated BENZOCAINE; BENZETHONIUM CHLORIDE 200; 2 mg/g; mg/g E 20171231 11509-0411_00184845-b409-4bad-9867-e5efeb360f02 11509-0411 HUMAN OTC DRUG Odor Eaters Foot and Sneaker tolnaftate SPRAY TOPICAL 20010901 OTC MONOGRAPH FINAL part333 Combe Incorporated TOLNAFTATE 10 mg/g E 20171231 11509-4402_16c6731e-7af0-40d5-ae94-d9289c5ad10a 11509-4402 HUMAN OTC DRUG VAGISIL Anti-Itch Medicated Creme Maximum Strength Benzocaine and Resorcinol CREAM TOPICAL 19740801 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated BENZOCAINE; RESORCINOL 200; 30 mg/g; mg/g N 20191231 11509-5035_e4a7e9d7-34a1-41f4-96f2-25e38dd641e3 11509-5035 HUMAN OTC DRUG VAGISIL Anti-Itch Medicated Wipes Maximum Strength pramoxine hydrochloride CLOTH TOPICAL 20050628 OTC MONOGRAPH NOT FINAL part347 Combe Incorporated PRAMOXINE HYDROCHLORIDE 10 mg/g N 20191231 11509-5058_e4a7e9d7-34a1-41f4-96f2-25e38dd641e3 11509-5058 HUMAN OTC DRUG VAGISIL Anti-Itch Medicated Wipes Maximum Strength pramoxine hydrochloride CLOTH TOPICAL 20050628 OTC MONOGRAPH NOT FINAL part347 Combe Incorporated PRAMOXINE HYDROCHLORIDE 10 mg/g N 20191231 11509-5101_bd509618-9b67-45d4-aca3-94d69448cd8c 11509-5101 HUMAN OTC DRUG Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula Hydrocortisone Acetate CREAM TOPICAL 20160130 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated HYDROCORTISONE ACETATE 280 mg/28g N 20191231 11509-5103_2fefc051-0fd6-45b8-bf55-31e7831857bb 11509-5103 HUMAN OTC DRUG VAGISIL Anti-Itch Creme Regular Strength Benzocaine and Resorcinol CREAM TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated BENZOCAINE; RESORCINOL 50; 20 mg/g; mg/g N 20191231 11509-6940_2fd17d5f-9763-44fa-ba2a-869d259148ee 11509-6940 HUMAN OTC DRUG Benzal Vagisil Creme Regular Strength Benzocaine and Resorcinol CREAM TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part348 Combe Incorporated BENZOCAINE; RESORCINOL 50; 20 mg/g; mg/g E 20171231 11523-0072_562b9637-22f5-2f0b-e054-00144ff8d46c 11523-0072 HUMAN OTC DRUG Tinactin Tolnaftate AEROSOL, POWDER TOPICAL 19930923 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC TOLNAFTATE 10 mg/g N 20181231 11523-0080_4f92239b-e726-5f30-e054-00144ff88e88 11523-0080 HUMAN OTC DRUG Chlor-Trimeton 4Hour Chlorpheniramine Maleate TABLET ORAL 19751231 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 11523-0096_1eb4ea9f-0aae-4854-e054-00144ff88e88 11523-0096 HUMAN OTC DRUG A and D Original Lanolin and Petrolatum OINTMENT TOPICAL 20091225 OTC MONOGRAPH FINAL part346 Bayer HealthCare LLC LANOLIN; PETROLATUM 136.4; 469.9 mg/g; mg/g N 20181231 11523-0096_4d72277d-0c4b-1bc3-e054-00144ff88e88 11523-0096 HUMAN OTC DRUG A and D Original Lanolin and Petrolatum OINTMENT TOPICAL 20030604 OTC MONOGRAPH FINAL part347 Bayer HealthCare LLC. LANOLIN; PETROLATUM 136.4; 469.9 mg/g; mg/g N 20181231 11523-0165_562b6aac-0682-25e9-e054-00144ff8d46c 11523-0165 HUMAN OTC DRUG Tinactin Tolnaftate AEROSOL, SPRAY TOPICAL 19930923 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC TOLNAFTATE 10 mg/g N 20181231 11523-0259_562ae869-63e5-0635-e054-00144ff8d46c 11523-0259 HUMAN OTC DRUG Mexsana Medicated Starch, Corn POWDER TOPICAL 19930923 OTC MONOGRAPH FINAL part347 Bayer HealthCare LLC STARCH, CORN 837 mg/g N 20181231 11523-0404_4fa6437a-8a93-67be-e054-00144ff8d46c 11523-0404 HUMAN OTC DRUG Solarcaine Lidocaine SPRAY TOPICAL 20120406 OTC MONOGRAPH NOT FINAL part348 Bayer HealthCare LLC. LIDOCAINE 5 mg/g N 20181231 11523-0430_60a2f896-82e5-30b8-e053-2a91aa0a60ba 11523-0430 HUMAN OTC DRUG Solarcaine cool aloe Lidocaine hydrochloride GEL TOPICAL 20120313 OTC MONOGRAPH NOT FINAL part348 Bayer HealthCare LLC. LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 11523-0461_531e51c5-a4b8-6e33-e054-00144ff88e88 11523-0461 HUMAN OTC DRUG Coppertone Sport SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 19.98; 79.92; 49.95; 49.95 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-0463_580f2345-12a5-5155-e053-2a91aa0ab013 11523-0463 HUMAN OTC DRUG Dr. Scholls Extra Thick Callus Removers Salicylic Acid DISC TOPICAL 19900814 OTC MONOGRAPH FINAL part358F Bayer HealthCare LLC. SALICYLIC ACID .4 g/1 N 20181231 11523-0464_5fb53c35-4af5-3c75-e053-2a91aa0a017e 11523-0464 HUMAN OTC DRUG Dr. Scholls Corn/Callus Remover Salicylic Acid SOLUTION TOPICAL 19900814 OTC MONOGRAPH FINAL part358F Bayer HealthCare LLC. SALICYLIC ACID 1.7 mg/mL N 20181231 11523-0465_580cff70-2518-b2d2-e053-2a91aa0a823a 11523-0465 HUMAN OTC DRUG Dr. Scholls Callus Removers Salicylic Acid DISC TOPICAL 19900814 20180930 OTC MONOGRAPH FINAL part358F Bayer HealthCare LLC. SALICYLIC ACID .4 g/1 N 20181231 11523-0468_580cf4f9-2c3c-6266-e053-2991aa0a8627 11523-0468 HUMAN OTC DRUG Dr. Scholls Clear Away Wart Remover Ultra Thin Discs Salicylic Acid DISC TOPICAL 20050412 20180331 OTC MONOGRAPH FINAL part358B Bayer Health Care LLC SALICYLIC ACID 4 mg/1 N 20181231 11523-0544_56b88f6d-d157-1499-e054-00144ff88e88 11523-0544 HUMAN OTC DRUG Lotrimin Antifungal Miconazole nitrate AEROSOL, POWDER TOPICAL 19930901 OTC MONOGRAPH FINAL part333C Bayer Healthcare LLC. MICONAZOLE NITRATE 20 mg/g N 20181231 11523-0602_7149c33e-a39d-4008-b3cf-9d919c6edc6f 11523-0602 HUMAN OTC DRUG Coppertone Sport High Performance SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.24; 100.8; 50.4; 100.8 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 11523-0627_580ec553-b77a-61bc-e053-2a91aa0a4aa8 11523-0627 HUMAN OTC DRUG Dr. Scholls Corn Removers Salicylic Acid DISC TOPICAL 19900814 OTC MONOGRAPH FINAL part358F Bayer HealthCare LLC SALICYLIC ACID 4 mg/1 N 20181231 11523-0629_580d5a08-eb60-ebb6-e053-2991aa0a6d3d 11523-0629 HUMAN OTC DRUG Dr. Scholls Ultra Thin Corn Removers Salicylic Acid DISC TOPICAL 19900814 20180831 OTC MONOGRAPH FINAL part358F Bayer Health Care LLC. SALICYLIC ACID .4 g/1 N 20181231 11523-0631_5fc03f05-1904-1bc0-e053-2a91aa0a368f 11523-0631 HUMAN OTC DRUG Dr. Scholls Clear Away Wart Remover Plantar salicylic acid DISC TOPICAL 19900814 OTC MONOGRAPH FINAL part358B Bayer HealthCare LLC. SALICYLIC ACID 4 mg/1 N 20181231 11523-0635_562b09d6-f9af-0e30-e054-00144ff8d46c 11523-0635 HUMAN OTC DRUG DuoFilm Wart Remover Salicylic Acid LIQUID TOPICAL 19900814 OTC MONOGRAPH FINAL part358B Bayer HealthCare LLC SALICYLIC ACID 150.28 mg/mL N 20181231 11523-0638_56b8d6a7-e2ff-213b-e054-00144ff88e88 11523-0638 HUMAN OTC DRUG Dr. Scholls Duragel Corn Removers Salicyclic Acid DISC TOPICAL 20160201 OTC MONOGRAPH FINAL part358F Bayer Health Care LLC. SALICYLIC ACID .4 g/1 N 20181231 11523-0642_56b90177-2c20-2147-e054-00144ff88e88 11523-0642 HUMAN OTC DRUG Dr. Scholls Clear Away Wrt Removers with Duragel Technology Salicylic Acid DISC TOPICAL 20160201 OTC MONOGRAPH FINAL part358B Bayer Health Care LLC. SALICYLIC ACID .4 g/1 N 20181231 11523-0644_56b88f6d-d193-1499-e054-00144ff88e88 11523-0644 HUMAN OTC DRUG Dr. Scholls Duragel Callus Removers Salicyclic Acid DISC TOPICAL 20160201 OTC MONOGRAPH FINAL part358F Bayer Health Care LLC. SALICYLIC ACID .4 g/1 N 20181231 11523-0728_7807d6bb-86a9-4eea-8a8e-053eebd16a83 11523-0728 HUMAN OTC DRUG Chlor-Trimeton 12 Hour Chlorpheniramine Maleate TABLET, EXTENDED RELEASE ORAL 20100104 NDA NDA007638 Schering Plough HealthCare Products CHLORPHENIRAMINE MALEATE 12 mg/1 E 20171231 11523-0753_34d9d885-f6a2-74ee-e054-00144ff8d46c 11523-0753 HUMAN OTC DRUG Dr. Scholls One Step Corn Removers Salicylic Acid DISC TOPICAL 20050412 OTC MONOGRAPH FINAL part358F Bayer HealthCare LLC SALICYLIC ACID .4 g/1 N 20181231 11523-0777_562b3777-560c-04b6-e054-00144ff88e88 11523-0777 HUMAN OTC DRUG Tinactin Tolnaftate AEROSOL, POWDER TOPICAL 19930923 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC. TOLNAFTATE 10 mg/g N 20181231 11523-0919_56b88f6d-d186-1499-e054-00144ff88e88 11523-0919 HUMAN OTC DRUG Lotrimin Antifungal Miconazole nitrate POWDER TOPICAL 19930901 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC. MICONAZOLE NITRATE 20 mg/g N 20181231 11523-0934_56b7d638-a8bc-1d9e-e054-00144ff8d46c 11523-0934 HUMAN OTC DRUG Tinactin Tolnaftate CREAM TOPICAL 19930923 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC. TOLNAFTATE 10 mg/g N 20181231 11523-0963_4d85bdd6-9e23-45d6-e054-00144ff88e88 11523-0963 HUMAN OTC DRUG Lotrimin Clotrimazole CREAM TOPICAL 20020201 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC CLOTRIMAZOLE 10 mg/g N 20181231 11523-1125_4d857861-3932-2899-e054-00144ff8d46c 11523-1125 HUMAN OTC DRUG Lotrimin Antifungal Clotrimazole CREAM TOPICAL 20020201 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC. CLOTRIMAZOLE 10 mg/g N 20181231 11523-1159_5faddf54-ff97-d97d-e053-2991aa0a02b0 11523-1159 HUMAN OTC DRUG Afrin Original Pump Mist Oxymetazoline hydrochloride SPRAY, METERED NASAL 19750714 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 11523-1167_48f397f4-3b06-188f-e054-00144ff8d46c 11523-1167 HUMAN OTC DRUG Afrin Original Oxymetazoline hydrochloride SPRAY NASAL 19750714 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 11523-1190_56b7c5f0-9bc1-0125-e054-00144ff88e88 11523-1190 HUMAN OTC DRUG Tinactin Tolnaftate CREAM TOPICAL 19930923 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC. TOLNAFTATE 10 mg/g N 20181231 11523-1272_56b88f6d-d145-1499-e054-00144ff88e88 11523-1272 HUMAN OTC DRUG Lotrimin Antifungal Miconazole nitrate AEROSOL, POWDER TOPICAL 19930901 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC. MICONAZOLE NITRATE 20 mg/g N 20181231 11523-1305_59847e3d-f900-4b26-839a-6120e82ea8ca 11523-1305 HUMAN OTC DRUG Coricidin HBP Maximum Strength Flu Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide TABLET, FILM COATED ORAL 20000831 OTC MONOGRAPH FINAL part341 MSD Consumer Care, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 500; 2; 15 mg/1; mg/1; mg/1 N 20181231 11523-1314_5174e222-66fd-1bd7-e054-00144ff88e88 11523-1314 HUMAN OTC DRUG A and D Dimethicone and Zinc Oxide CREAM TOPICAL 20091225 OTC MONOGRAPH FINAL part347 Bayer HealthCare LLC. DIMETHICONE; ZINC OXIDE 11.09; 110.09 mg/g; mg/g N 20181231 11523-1350_4e018151-a16b-2b32-e054-00144ff88e88 11523-1350 HUMAN OTC DRUG Afrin No Drip Severe Congestion Oxymetazoline hydrochloride SPRAY, METERED NASAL 20000831 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 11523-1527_5aa882dd-430e-a337-e053-2991aa0a4531 11523-1527 HUMAN OTC DRUG Claritin Loratadine TABLET ORAL 19930412 NDA NDA019658 Bayer HealthCare LLC. LORATADINE 10 mg/1 N 20181231 11523-1702_5bac2cfd-c854-fa1b-e053-2a91aa0aef2b 11523-1702 HUMAN OTC DRUG Afrin No Drip Sinus Pump Mist Oxymetazoline hydrochloride SPRAY, METERED NASAL 20000831 20180601 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 11523-1783_4e0038c8-5fa5-3a28-e054-00144ff8d46c 11523-1783 HUMAN OTC DRUG Afrin No Drip Extra Moisturizing Oxymetazoline hydrochloride SPRAY, METERED NASAL 20000831 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 11523-3142_5faf4114-87cb-255f-e053-2a91aa0a755d 11523-3142 HUMAN OTC DRUG Afrin No Drip Original Pump Mist Oxymetazoline hydrochloride SPRAY, METERED NASAL 19990831 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 11523-3220_4e042f5b-3ef1-1830-e054-00144ff88e88 11523-3220 HUMAN OTC DRUG Afrin No-Drip Allergy Sinus Oxymetazoline hydrochloride SPRAY, METERED NASAL 20160830 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC OXYMETAZOLINE HYDROCHLORIDE .05 mg/mL N 20181231 11523-4112_60664f3c-0738-2cdb-e053-2991aa0ae123 11523-4112 HUMAN OTC DRUG Afrin Sinus Oxymetazoline hydrochloride SPRAY NASAL 19960830 20180401 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 11523-4140_4fa669ce-e385-1ea1-e054-00144ff88e88 11523-4140 HUMAN OTC DRUG Lotrimin Antifungal Miconazole nitrate AEROSOL, POWDER TOPICAL 19930901 OTC MONOGRAPH FINAL part333C Bayer Healthcare LLC. MICONAZOLE NITRATE 20 mg/g N 20181231 11523-4162_562b6aac-0692-25e9-e054-00144ff8d46c 11523-4162 HUMAN OTC DRUG Tinactin Antifungal Tolnaftate AEROSOL, POWDER TOPICAL 20140228 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC TOLNAFTATE 10 mg/g N 20181231 11523-4325_5022019b-ae24-0ce3-e054-00144ff88e88 11523-4325 HUMAN OTC DRUG Coricidin HBP Cold and Flu Acetaminophen and Chlorpheniramine maleate TABLET, FILM COATED ORAL 20131001 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 325; 2 mg/1; mg/1 N 20181231 11523-4326_50467f84-01a6-3db0-e054-00144ff8d46c 11523-4326 HUMAN OTC DRUG Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine Chlorpheniramine maleate and Dextromethorphan hydrobromide TABLET, FILM COATED ORAL 20130501 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 11523-4327_56b88f6d-d168-1499-e054-00144ff88e88 11523-4327 HUMAN OTC DRUG Lotrimin AF Antifungal Miconazole nitrate SPRAY TOPICAL 19930901 OTC MONOGRAPH FINAL part333C Bayer Healthcare LLC. MICONAZOLE NITRATE 20 mg/g N 20181231 11523-4328_51c85292-108e-1bc3-e054-00144ff88e88 11523-4328 HUMAN OTC DRUG Claritin Loratadine TABLET, CHEWABLE ORAL 20060823 NDA NDA021891 Bayer HealthCare LLC. LORATADINE 5 mg/1 N 20181231 11523-4329_3454e6c8-e526-13fd-e054-00144ff88e88 11523-4329 HUMAN OTC DRUG Claritin Reditabs Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20021127 NDA NDA020704 Bayer Healthcare LLC LORATADINE 10 mg/1 N 20181231 11523-4330_56ba8688-6b4e-5719-e054-00144ff88e88 11523-4330 HUMAN OTC DRUG Claritin loratadine TABLET, CHEWABLE ORAL 20150925 NDA NDA021891 Bayer HealthCare LLC. LORATADINE 5 mg/1 N 20181231 11523-4332_54c41112-81a7-1475-e054-00144ff8d46c 11523-4332 HUMAN OTC DRUG Claritin-D 24 Hour Loratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE ORAL 20091201 NDA NDA020470 Bayer HealthCare LLC. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 11523-4336_562b3777-55fa-04b6-e054-00144ff88e88 11523-4336 HUMAN OTC DRUG Dr. Scholls Odor-X Foot and Sneaker Tolnaftate AEROSOL, POWDER TOPICAL 19930923 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC. TOLNAFTATE 10 mg/g N 20181231 11523-4338_5a588707-07e4-11ed-e053-2991aa0a4334 11523-4338 HUMAN OTC DRUG Lotrimin Ultra Athletes Foot Butenafine hydrochloride CREAM TOPICAL 20020222 NDA NDA021307 Bayer Healthcare LLC. BUTENAFINE HYDROCHLORIDE 1 g/100g N 20181231 11523-4339_4d85da2f-67c8-37ab-e054-00144ff8d46c 11523-4339 HUMAN OTC DRUG Lotrimin Ultra Jock Itch Butenafine hydrochloride CREAM TOPICAL 20020222 NDA NDA021307 Bayer Healthcare LLC. BUTENAFINE HYDROCHLORIDE 1 g/100g N 20181231 11523-4357_4b513608-bfb5-44bd-e054-00144ff88e88 11523-4357 HUMAN OTC DRUG MiraLAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20070201 NDA NDA022015 Bayer HealthCare LLC. POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 11523-4358_513ca24f-1263-4a2d-e054-00144ff8d46c 11523-4358 HUMAN OTC DRUG Coricidin HBP Nighttime Multi-Symptom Cold Acetaminophen,Dextromethorphan hydrobromide, doxylamine succinate LIQUID ORAL 20151120 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 6.25; 325; 15 mg/15mL; mg/15mL; mg/15mL N 20181231 11523-4359_5aa882dd-430e-a337-e053-2991aa0a4531 11523-4359 HUMAN OTC DRUG Claritin Loratadine TABLET ORAL 19930412 NDA NDA019658 Bayer HealthCare LLC. LORATADINE 10 mg/1 N 20181231 11523-4360_559d7aba-7aee-6e08-e054-00144ff88e88 11523-4360 HUMAN OTC DRUG Children Claritin Allergy loratadine SOLUTION ORAL 20150526 NDA NDA020641 Bayer HealthCare LLC. LORATADINE 5 mg/5mL N 20181231 11523-4362_56b7d5b4-fdd8-0c40-e054-00144ff8d46c 11523-4362 HUMAN OTC DRUG Tinactin Super Absorbent Tolnaftate POWDER TOPICAL 19930923 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC. TOLNAFTATE 10 mg/g N 20181231 11523-4765_5046c6f5-87e4-4ab7-e054-00144ff8d46c 11523-4765 HUMAN OTC DRUG Coricidin HBP Day and Night Dextromethorphan Hydrobromide, Guaifenesin, Acetaminophen, Chlorpheniramine maleate KIT 20090828 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. N 20181231 11523-6549_4d85da2f-67a9-37ab-e054-00144ff8d46c 11523-6549 HUMAN OTC DRUG Lotrimin Clotrimazole CREAM TOPICAL 20090102 OTC MONOGRAPH FINAL part333C Bayer HealthCare LLC. CLOTRIMAZOLE 10 mg/g N 20181231 11523-6655_55ed2b95-2fbc-1c9f-e054-00144ff8d46c 11523-6655 HUMAN OTC DRUG Claritin Loratadine TABLET ORAL 19930412 NDA NDA019658 Bayer HealthCare LLC LORATADINE 10 mg/1 N 20181231 11523-7020_5faf19f9-4dde-73bd-e053-2991aa0a9773 11523-7020 HUMAN OTC DRUG Afrin Severe Congestion Oxymetazoline hydrochloride SPRAY NASAL 20000831 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 11523-7053_4987f62e-8fac-0d1b-e054-00144ff88e88 11523-7053 HUMAN OTC DRUG Coppertone Sport Sunscreen Lip Balm SPF 30 avobenzone, octisalate, octocrylene, and oxybenzone STICK TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 30; 90.9; 50 mg/g; mg/g; mg/g; mg/g N 20181231 11523-7054_6294c2f4-8a16-60ee-e053-2a91aa0a370f 11523-7054 HUMAN OTC DRUG Coppertone ultraGUARD SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.24; 100.8; 50.4; 100.8 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 11523-7061_df1c625f-5286-4918-a054-f453b32086a9 11523-7061 HUMAN OTC DRUG Coppertone oil free SPF 30 avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20.7; 134.55; 51.75; 20.7; 41.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 11523-7094_5de442f1-fc68-d030-e053-2a91aa0a30fc 11523-7094 HUMAN OTC DRUG Bain de Soleil Mega Tan SPF 4 Octinoxate and Octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. OCTINOXATE; OCTOCRYLENE 35; 10 mg/mL; mg/mL N 20181231 11523-7141_3280a1ac-9645-34b1-e054-00144ff8d46c 11523-7141 HUMAN OTC DRUG Coppertone oil free faces Sunscreen SPF 30 avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20.7; 134.55; 51.75; 20.7; 41.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7154_47e50ab6-5028-0fe0-e054-00144ff8d46c 11523-7154 HUMAN OTC DRUG Lotrimin Ultra Antifungal Butenafine Hydrochloride CREAM TOPICAL 19930923 NDA NDA021307 Bayer HealthCare LLC. BUTENAFINE HYDROCHLORIDE 10 mg/g N 20181231 11523-7155_47e50ab6-503b-0fe0-e054-00144ff8d46c 11523-7155 HUMAN OTC DRUG Lotrimin Ultra Jock Itch Antifungal Butenafine Hydrochloride CREAM TOPICAL 19930923 NDA NDA021307 Bayer HealthCare LLC. BUTENAFINE HYDROCHLORIDE 10 mg/g N 20181231 11523-7157_3454e6c8-e526-13fd-e054-00144ff88e88 11523-7157 HUMAN OTC DRUG Claritin Reditabs Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20021127 NDA NDA020704 Bayer Healthcare LLC LORATADINE 10 mg/1 N 20181231 11523-7158_50214302-540d-5396-e054-00144ff88e88 11523-7158 HUMAN OTC DRUG Coricidin HBP Chest Congestion And Cough Dextromethorphan hydrobromide and Guaifenesin CAPSULE, GELATIN COATED ORAL 20000831 OTC MONOGRAPH FINAL part341 Bayer HealthCare LLC. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 N 20181231 11523-7160_5aa882dd-430e-a337-e053-2991aa0a4531 11523-7160 HUMAN OTC DRUG Claritin Loratadine TABLET ORAL 19930412 NDA NDA019658 Bayer HealthCare LLC. LORATADINE 10 mg/1 N 20181231 11523-7162_54c41112-81bb-1475-e054-00144ff8d46c 11523-7162 HUMAN OTC DRUG Claritin-D 12 Hour Loratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE ORAL 20091201 NDA NDA019670 Bayer HealthCare LLC. LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 11523-7170_49881435-b85d-3bac-e054-00144ff8d46c 11523-7170 HUMAN OTC DRUG Coppertone Tanning Dry Oil SPF 15 Avobenzone, Homosalate, Octisalate, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 16.89; 84.47; 42.23; 25.34 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7183_49888885-06c1-1fcb-e054-00144ff88e88 11523-7183 HUMAN OTC DRUG Coppertone SPORT SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.76; 85.88; 42.94; 17.17; 34.35 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7184_4937a08d-3a7f-6d79-e054-00144ff88e88 11523-7184 HUMAN OTC DRUG Coppertone UltraGuard SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.76; 85.87; 42.94; 17.17; 34.35 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7189_3d9163a0-8c2f-1c3f-e054-00144ff8d46c 11523-7189 HUMAN OTC DRUG Bain de Soleil Orange Gelee SPF 4 Octinoxate GEL TOPICAL 19990521 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC OCTINOXATE 25 mg/g N 20181231 11523-7197_4e89e32f-2c34-5b37-e054-00144ff8d46c 11523-7197 HUMAN OTC DRUG Claritin loratadine SOLUTION ORAL 20110301 NDA NDA020641 Bayer HealthCare LLC. LORATADINE 5 mg/5mL N 20181231 11523-7200_4f449fbb-82aa-2617-e054-00144ff88e88 11523-7200 HUMAN OTC DRUG Claritin Liqui-Gels Loratadine CAPSULE, LIQUID FILLED ORAL 20080616 NDA NDA021952 Bayer HealthCare LLC. LORATADINE 10 mg/1 N 20181231 11523-7202_482ed192-0467-0439-e054-00144ff88e88 11523-7202 HUMAN OTC DRUG Claritin Reditabs Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20061212 NDA NDA021993 Bayer HealthCare LLC LORATADINE 5 mg/1 N 20181231 11523-7204_4d724515-5fbd-1494-e054-00144ff88e88 11523-7204 HUMAN OTC DRUG A and D First Aid Lanolin and petrolatum OINTMENT TOPICAL 20030604 OTC MONOGRAPH FINAL part347 Bayer HealthCare LLC LANOLIN; PETROLATUM 136.4; 469.9 mg/g; mg/g N 20181231 11523-7206_60c7dc1d-6151-6bc6-e053-2a91aa0a39e4 11523-7206 HUMAN OTC DRUG Coppertone ultraGUARD SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 72.1; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 11523-7207_493721ba-ddce-1f4e-e054-00144ff8d46c 11523-7207 HUMAN OTC DRUG Coppertone Water Babies SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19930512 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 72.1; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7214_562b3777-561c-04b6-e054-00144ff88e88 11523-7214 HUMAN OTC DRUG Dr. Scholls Ingrown Toenail Pain Reliever Sodium Sulfide GEL TOPICAL 20030507 OTC MONOGRAPH FINAL part358D Bayer HealthCare LLC. SODIUM SULFIDE 10 mg/g N 20181231 11523-7216_49881435-b86e-3bac-e054-00144ff8d46c 11523-7216 HUMAN OTC DRUG Coppertone Tanning Dry Oil SPF 10 Homosalate, Octinoxate, Octisalate, and Oxybenzone SPRAY TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 42.2; 63.3; 42.2; 25.32 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7218_26f3205d-4445-4296-84b3-e3a0134f77c0 11523-7218 HUMAN OTC DRUG Coppertone UltraGuard SPF 15 Avobenzone, Homosalate, Octisalate, and Oxybenzone AEROSOL, SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 16.89; 84.47; 42.235; 25.34 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 11523-7219_60dc2f2d-d5cf-531e-e053-2a91aa0aaa3d 11523-7219 HUMAN OTC DRUG Coppertone Sport AccuSpray SPF 15 Avobenzone, Homosalate, Octisalate, and Oxybenzone SPRAY TOPICAL 20140131 20181201 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 16.91; 84.55; 42.27; 25.36 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7221_531e4417-1848-5eb5-e054-00144ff88e88 11523-7221 HUMAN OTC DRUG Coppertone Sport High Performance SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.3; 131.3; 50.5; 50.5; 60.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7226_355128d1-e4fe-4c8f-e054-00144ff88e88 11523-7226 HUMAN OTC DRUG Dr. Scholls Clear Away Wart Remover One Step Salicylic Acid DISC TOPICAL 19900814 OTC MONOGRAPH FINAL part358B Bayer Health Care LLC SALICYLIC ACID 4 mg/1 N 20181231 11523-7227_580cf4f9-2c28-6266-e053-2991aa0a8627 11523-7227 HUMAN OTC DRUG Dr. Scholls Clear Away Wart Remover Salicylic Acid SOLUTION TOPICAL 19900814 20190131 OTC MONOGRAPH FINAL part358B Bayer HealthCare LLC. SALICYLIC ACID 150 mg/mL N 20181231 11523-7228_4988672c-5052-39fd-e054-00144ff8d46c 11523-7228 HUMAN OTC DRUG Coppertone Sport SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.03; 86.76; 43.38; 34.7; 43.38 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7231_3e8a193e-fc98-2a9f-e054-00144ff8d46c 11523-7231 HUMAN OTC DRUG Coppertone waterBABIES Sunscreen SPF 50 avobenzone, homosalate, octisalate, octocrylene, and oxybenzone AEROSOL TOPICAL 19930512 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 130; 50; 20; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7234_4b513608-bfb5-44bd-e054-00144ff88e88 11523-7234 HUMAN OTC DRUG MiraLAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20070201 NDA NDA022015 Bayer HealthCare LLC. POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 11523-7237_5aa882dd-430e-a337-e053-2991aa0a4531 11523-7237 HUMAN OTC DRUG Claritin Loratadine TABLET ORAL 19930412 NDA NDA019658 Bayer HealthCare LLC. LORATADINE 10 mg/1 N 20181231 11523-7243_49379ae6-9d93-6a3f-e054-00144ff88e88 11523-7243 HUMAN OTC DRUG Coppertone UltraGuard SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.03; 86.76; 43.38; 34.7; 43.38 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7250_4987e688-4c84-2d5c-e054-00144ff8d46c 11523-7250 HUMAN OTC DRUG Coppertone Tanning Dry Oil SPF 4 Homosalate and Oxybenzone SPRAY TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. HOMOSALATE; OXYBENZONE 82.22; 16.44 mg/mL; mg/mL N 20181231 11523-7258_531dcb97-8bee-277e-e054-00144ff8d46c 11523-7258 HUMAN OTC DRUG Coppertone Sport High Performance Faces SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.3; 131.3; 50.5; 50.5; 60.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7265_602597d1-9aaf-7305-e053-2991aa0a212c 11523-7265 HUMAN OTC DRUG Zegerid OTC Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20100401 NDA NDA022281 Bayer HealthCare LLC OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 N 20191231 11523-7268_4b513608-bfb5-44bd-e054-00144ff88e88 11523-7268 HUMAN OTC DRUG MiraLAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20070201 NDA NDA022015 Bayer HealthCare LLC. POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 11523-7272_49376fa5-93ec-2b78-e054-00144ff8d46c 11523-7272 HUMAN OTC DRUG Coppertone UltraGuard SPF 70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.86; 134.3; 44.77; 89.53; 53.72 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7276_5ad1ca2b-311a-b8c2-e053-2a91aa0a2f77 11523-7276 HUMAN OTC DRUG Zegerid OTC omeprazole and sodium bicarbonate CAPSULE, GELATIN COATED ORAL 20171001 ANDA ANDA201361 Bayer HealthCare LLC. OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 N 20181231 11523-7281_62d2d52e-8227-0847-e053-2a91aa0ad36e 11523-7281 HUMAN OTC DRUG Coppertone Kids SPF 70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 103; 61.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 11523-7283_e39b8d7f-8edf-4573-8217-b4345253e83a 11523-7283 HUMAN OTC DRUG Coppertone Sport SPF 80 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 103; 61.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 11523-7289_a1e89ac9-af2c-41f1-9bb8-6892ce99934f 11523-7289 HUMAN OTC DRUG Coppertone Water Babies Sunscreen SPF 70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19930512 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.63; 153.15; 51.05; 102.1; 61.26 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 11523-7290_5420de56-dfeb-74dd-e054-00144ff8d46c 11523-7290 HUMAN OTC DRUG Coppertone waterBABIES Pure and Simple SPF 50 octinoxate, octisalate, and zinc oxide LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer Healthcare LLC. ZINC OXIDE; OCTINOXATE; OCTISALATE 164.72; 85.2; 56.8 mg/mL; mg/mL; mg/mL N 20181231 11523-7291_11ad1911-e451-4094-9b3a-de933b682dd7 11523-7291 HUMAN OTC DRUG Coppertone SPF 15 avobenzone, homosalate, octisalate, and octocrylene LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20.06; 100.3; 50.15; 50.15 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 11523-7300_5c79ffdb-5bb4-1044-e053-2991aa0a0ee6 11523-7300 HUMAN OTC DRUG Coppertone Sensitive Skin SPF 50 Octinoxate, Octisalate, and Zinc Oxide LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. OCTINOXATE; OCTISALATE; ZINC OXIDE 85.2; 56.8; 164.72 mg/mL; mg/mL; mg/mL N 20181231 11523-7301_62d30e4c-97b8-3d60-e053-2a91aa0a8adf 11523-7301 HUMAN OTC DRUG Coppertone Kids SPF 50 Octinoxate, Octisalate, and Zinc Oxide LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer Healthcare LLC. OCTINOXATE; OCTISALATE; ZINC OXIDE 85.2; 56.8; 164.72 mg/mL; mg/mL; mg/mL N 20191231 11523-7302_3d9163a0-8c66-1c3f-e054-00144ff8d46c 11523-7302 HUMAN OTC DRUG Coppertone KIDS SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.03; 86.76; 43.38; 34.7; 43.38 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7303_38899057-dee4-4137-e054-00144ff8d46c 11523-7303 HUMAN OTC DRUG Coppertone Sensitive Skin SPF 50 Octinoxate, octisalate, and zinc oxide LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC OCTINOXATE; OCTISALATE; ZINC OXIDE 85.2; 56.8; 164.72 mg/mL; mg/mL; mg/mL N 20181231 11523-7306_62d346e4-be47-56ee-e053-2991aa0a0788 11523-7306 HUMAN OTC DRUG Coppertone KIDS SPF 55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20191231 11523-7310_493721ba-ddbe-1f4e-e054-00144ff8d46c 11523-7310 HUMAN OTC DRUG Coppertone Water BABIES SPF 55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7312_60a31cd8-a3aa-5af4-e053-2a91aa0af27c 11523-7312 HUMAN OTC DRUG Coppertone Sport Continuous SPF 100 Plus Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20140811 20201201 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE; OCTINOXATE 137.47; 45.82; 27.49; 54.99; 91.65; 18.33 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7316_3d2eba64-2e57-03f1-e054-00144ff8d46c 11523-7316 HUMAN OTC DRUG Coppertone Kids Sunscreen SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.91; 134.57; 44.86; 89.71; 53.83 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7324_c784357b-e11b-4650-9fce-16e0083cc669 11523-7324 HUMAN OTC DRUG Coppertone Water Babies Foaming Sunscreen SPF 75 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990512 OTC MONOGRAPH NOT FINAL part352 MSD Consumer Care, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 11523-7325_62d272e2-2734-da97-e053-2a91aa0a9eb5 11523-7325 HUMAN OTC DRUG Coppertone Sport SPF 100 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.54; 152.7; 50.9; 101.8; 61.08 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 11523-7341_4b513608-bfb5-44bd-e054-00144ff88e88 11523-7341 HUMAN OTC DRUG MiraLAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20070201 NDA NDA022015 Bayer HealthCare LLC. POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 11523-7350_32805bee-58fd-04cd-e054-00144ff8d46c 11523-7350 HUMAN OTC DRUG Coppertone Oil Free Faces SPF 50 Plus avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.63; 153.15; 51.05; 102.1; 61.26 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7354_49369038-18ee-0860-e054-00144ff8d46c 11523-7354 HUMAN OTC DRUG Coppertone Wet and Clear SPF 50 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.73; 89.11; 40.1; 80.2; 44.56 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7355_5c783852-e664-2de0-e053-2991aa0a67c8 11523-7355 HUMAN OTC DRUG Coppertone Wet and Clear Kids SPF 50 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.73; 89.11; 40.1; 80.2; 44.56 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7357_60dc5b75-9aa0-bbe2-e053-2991aa0ade70 11523-7357 HUMAN OTC DRUG Coppertone KIDS SPF 50 Avobenzone, Homosalate, Octisalate, and Oxybenzone AEROSOL, SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 26; 130.02; 43.34; 52.01 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7360_60dc17a2-afda-2d5f-e053-2a91aa0a3cf5 11523-7360 HUMAN OTC DRUG Coppertone Clearly Sheer For Beach and Pool SPF 30 Avobenzone, octocrylene, and oxybenzone SPRAY TOPICAL 20131202 20181201 OTC MONOGRAPH NOT FINAL part352 Bayer Healthcare LLC. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 20; 90; 30 mg/g; mg/g; mg/g N 20181231 11523-7361_60dc21fa-b283-725e-e053-2991aa0a24f7 11523-7361 HUMAN OTC DRUG Coppertone Clearly Sheer For Beach and Pool SPF 50 Plus Avobenzone, homosalate, octisalate, octocrylene, and oxybenzone SPRAY TOPICAL 20131202 20181201 OTC MONOGRAPH NOT FINAL part352 Bayer Healthcare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 45; 90; 20 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7362_60dc17a2-aff2-2d5f-e053-2a91aa0a3cf5 11523-7362 HUMAN OTC DRUG Coppertone kids SPF 70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, FOAM TOPICAL 20140101 20181201 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7363_4937094e-547e-1220-e054-00144ff8d46c 11523-7363 HUMAN OTC DRUG Coppertone water BABIES SPF 70 plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, FOAM TOPICAL 20140201 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 31.2; 156; 52; 104; 62.4 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7364_531e617e-6d3a-6f25-e054-00144ff88e88 11523-7364 HUMAN OTC DRUG Coppertone Sport SPF 75 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140301 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 103; 61.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7365_60dc21fa-b296-725e-e053-2991aa0a24f7 11523-7365 HUMAN OTC DRUG Coppertone Clearly Sheer For Sunny Days SPF 15 Avobenzone, homosalate, octisalate, and octocrylene LOTION TOPICAL 20140501 20181201 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE 46.27; 50.85; 30.51; 30.51 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7367_60dc10cb-5109-29cc-e053-2a91aa0a57f0 11523-7367 HUMAN OTC DRUG Coppertone Clearly Sheer For Sunny Days SPF 30 Face Avobenzone, homosalate, octisalate, and octocrylene LOTION TOPICAL 20131216 20181201 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.7; 102.5; 46.6; 82 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7370_49369038-18dc-0860-e054-00144ff8d46c 11523-7370 HUMAN OTC DRUG Coppertone wet n clear SPF 30 Avobenzone, Homosalate, Octisalate, octocrylene, and Oxybenzone SPRAY TOPICAL 20130331 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.32; 87.74; 39.48; 43.87; 35.09 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7371_3071343c-6a6e-3738-e054-00144ff88e88 11523-7371 HUMAN OTC DRUG Coppertone kids SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 Bayer Healthcare LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.3; 131.3; 50.5; 50.5; 60.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7372_531e4b6c-66fc-6abe-e054-00144ff88e88 11523-7372 HUMAN OTC DRUG Coppertone Sport High Performance SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.3; 118.1; 45.4; 45.4; 54.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7373_60dc33e2-0e65-58b7-e053-2a91aa0ae8ff 11523-7373 HUMAN OTC DRUG Coppertone Sport AccuSpray SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20140117 20181201 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.76; 85.88; 42.94; 17.17; 34.35 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7377_62080932-0805-34fc-e053-2a91aa0a401b 11523-7377 HUMAN OTC DRUG Coppertone Waterbabies Pure and Simple Mineral SPF 50 Octinoxate, Octisalate, Zinc Oxide LOTION TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer Healthcare LLC. OCTISALATE; OCTINOXATE; ZINC OXIDE 56.8; 85.6; 164.7 mg/mL; mg/mL; mg/mL N 20191231 11523-7378_6280b919-6b15-365e-e053-2991aa0a0b9c 11523-7378 HUMAN OTC DRUG Coppertone Sport Free SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20180201 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.8; 102.8; 46.2; 82.2 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 11523-7379_62942749-9d02-b043-e053-2a91aa0ae5a6 11523-7379 HUMAN OTC DRUG Coppertone Kids Sport SPF 50 avobenzone, octisalate, octocrylene, oxybenzone AEROSOL, SPRAY TOPICAL 20180201 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 23.2; 34.9; 69.8; 46.5 mg/g; mg/g; mg/g; mg/g N 20191231 11523-7385_4988672c-5064-39fd-e054-00144ff8d46c 11523-7385 HUMAN OTC DRUG Coppertone Sport SPF 15 Coppertone Sport SPRAY TOPICAL 20151115 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE 16.52; 37.17; 57.82 mg/mL; mg/mL; mg/mL N 20181231 11523-7386_5bfbe8d5-19a7-3dc6-e053-2a91aa0a1e73 11523-7386 HUMAN OTC DRUG Coppertone Defend and Care Face Oil Free SPF 30 Avobenzone,Homosalate,Octisalate,Octocrylene LOTION TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.2; 80.6; 45.3; 60.4 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7387_5c4d1811-f587-1835-e053-2991aa0a6b96 11523-7387 HUMAN OTC DRUG Coppertone Defend and Care Face Sensitive Skin SPF 50 Octinoxate, Octisalate, Zinc Oxide LOTION TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. OCTINOXATE; OCTISALATE; ZINC OXIDE 85.2; 56.8; 164.72 mg/mL; mg/mL; mg/mL N 20181231 11523-7388_5a2baa54-6650-3bd0-e053-2a91aa0a5f89 11523-7388 HUMAN OTC DRUG Coppertone Defend and Care Ultra Hydrating SPF 50 avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 31.02; 103.4; 47.05; 93.06; 51.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7389_626c47bc-bbc3-d84f-e053-2a91aa0af956 11523-7389 HUMAN OTC DRUG Coppertone Sport SPF 15 Coppertone Sport LOTION TOPICAL 20151101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OCTOCRYLENE; HOMOSALATE; OCTISALATE 20.16; 30.24; 50.4; 45.36 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 11523-7390_48f8b8b0-cfb1-5aee-e054-00144ff8d46c 11523-7390 HUMAN OTC DRUG Coppertone Clearly Sheer SPF 30 Coppertone Clearly Sheer LOTION TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 105.5; 30.7; 46.6; 82 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7394_60c7ea7a-59fe-5feb-e053-2991aa0a698e 11523-7394 HUMAN OTC DRUG Coppertone Sport SPF 30 Copertone Sport SPF 30 LOTION TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE 30.09; 80.24; 60.18; 45.14 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 11523-7395_626cbf3c-d3b9-3088-e053-2991aa0acb15 11523-7395 HUMAN OTC DRUG Coppertone Sport SPF 50 Coppertone Sport LOTION TOPICAL 20151101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.84; 102; 46.26; 82.24 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 11523-7399_48f813f1-7017-3d8f-e054-00144ff8d46c 11523-7399 HUMAN OTC DRUG Coppertone Clearly Sheer Faces SPF 50 Coppertone Clearly Sheer Faces LOTION TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 31.02; 103.4; 47.05; 93.06; 51.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7400_60cbb965-0f04-442a-e053-2a91aa0aa7bf 11523-7400 HUMAN OTC DRUG Coppertone Sport SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 30; 150; 50; 60; 100 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7401_5d6aa758-ffba-e6a2-e053-2991aa0a32ec 11523-7401 HUMAN OTC DRUG Coppertone Water Babies Stick SPF 50 Octinoxate, Octocrylene, Zinc Oxide STICK TOPICAL 20161130 OTC MONOGRAPH FINAL part352 Bayer Healthcare LLC. ZINC OXIDE; OCTINOXATE; OCTOCRYLENE 150; 75; 100 mg/g; mg/g; mg/g N 20181231 11523-7402_49887b46-fddc-4f5c-e054-00144ff8d46c 11523-7402 HUMAN OTC DRUG Coppertone Sport Lip Balm SPF 50 Avobenzone, Homosalate, Octisalate, Oxybenzone, Petrolatum STICK TOPICAL 20161130 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. PETROLATUM; HOMOSALATE; OXYBENZONE; OCTISALATE; AVOBENZONE 300; 150; 60; 50; 30 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7403_5da361b3-dd8c-5256-e053-2a91aa0a37a0 11523-7403 HUMAN OTC DRUG Coppertone Water Babies Pure And Simple Whipped SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20161130 OTC MONOGRAPH FINAL part352 Bayer Healthcare LLC. AVOBENZONE; HOMOSALATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE 30; 100; 60; 45; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7404_5c7810a6-cb7b-108c-e053-2991aa0a1936 11523-7404 HUMAN OTC DRUG Coppertone Clearly Sheer Whipped SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20161116 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE 45; 80; 30; 100 mg/g; mg/g; mg/g; mg/g N 20181231 11523-7405_60a2ee63-4645-3adc-e053-2991aa0a4cce 11523-7405 HUMAN OTC DRUG Coppertone Clearly Sheer Whipped SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20161117 OTC MONOGRAPH FINAL part352 Bayer Healthcare LLC. HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 100; 30; 45; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7406_5c6099e0-682e-f7c3-e053-2991aa0a3859 11523-7406 HUMAN OTC DRUG Coppertone Defend and Care Ultra Hydrate SPF 50 Avobenzone,Homosalate,Octisalate,Octocrylene,Oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; HOMOSALATE 21.9; 32.8; 65.7; 14.6; 73.08 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7407_5cc59ccf-ff5e-0e9b-e053-2991aa0a323d 11523-7407 HUMAN OTC DRUG Coppertone Defend and Care Ultra Hydrate Whipped SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer Healthcare LLC. OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE 45.4; 30.3; 101; 80.8 mg/g; mg/g; mg/g; mg/g N 20181231 11523-7409_626d2233-11d0-2fee-e053-2991aa0a38dc 11523-7409 HUMAN OTC DRUG Coppertone waterBABIES Pure and Simple Free SPF 50 avobenzone, homosalate, octisalate, octocrylene, oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. HOMOSALATE; OCTOCRYLENE; AVOBENZONE; OCTISALATE; OXYBENZONE 153.15; 102.1; 30.63; 51.05; 61.26 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 11523-7410_6245aeee-3091-2ba0-e053-2a91aa0ad426 11523-7410 HUMAN OTC DRUG Coppertone Sport Avobenzone, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. OCTISALATE; OCTOCRYLENE; AVOBENZONE; OXYBENZONE 45; 90; 30; 60 mg/g; mg/g; mg/g; mg/g N 20191231 11523-7411_5c7ac3e7-a6f1-e8da-e053-2a91aa0a0e87 11523-7411 HUMAN OTC DRUG Coppertone Defend and Care Ultra Hydrate Whipped SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene,Oxybenzone LOTION TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 30.3; 101; 45.4; 60.6; 40.4 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7412_5d30f078-3420-46af-e053-2a91aa0ab9ab 11523-7412 HUMAN OTC DRUG Coppertone Defend and Care Face Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 58.8; 29.4; 147; 49; 98 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7413_5acbdd20-69b0-8df5-e053-2a91aa0a6245 11523-7413 HUMAN OTC DRUG Coppertone Defend and Care Face Clear Zinc SPF 50 Octinoxate, Octisalate, Zinc Oxide LOTION TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. OCTINOXATE; OCTISALATE; ZINC OXIDE 79.5; 47.7; 102.8 mg/mL; mg/mL; mg/mL N 20181231 11523-7414_5c4fd2ef-56f3-0bc2-e053-2a91aa0a5dee 11523-7414 HUMAN OTC DRUG Coppertone Defend and Care Face Oil Free SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OCTOCRYLENE; HOMOSALATE; OCTISALATE 30.8; 82.2; 102.8; 46.2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7415_5ccb45ea-4bdb-123c-e053-2991aa0ad3fc 11523-7415 HUMAN OTC DRUG Coppertone Tanning Defend and Glow SPF 10 Homosalate, Octinoxate, Octisalate and Oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. OXYBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 25.32; 42.2; 63.3; 42.2 mg/g; mg/g; mg/g; mg/g N 20181231 11523-7416_5d30d405-4cc9-a736-e053-2a91aa0ad252 11523-7416 HUMAN OTC DRUG Coppertone Tanning Defend and Glow SPF 15 Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OXYBENZONE; HOMOSALATE; OCTISALATE 16.89; 25.34; 84.47; 42.23 mg/g; mg/g; mg/g; mg/g N 20181231 11523-7417_5d2f4b7b-f84e-bd9e-e053-2991aa0ab907 11523-7417 HUMAN OTC DRUG Coppertone Tanning Defend and Glow SPF 8 Octinoxate and Octocrylene LOTION TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. OCTINOXATE; OCTOCRYLENE 70.175; 30.075 mg/mL; mg/mL N 20181231 11523-7418_5d7e4594-4c4a-82fd-e053-2a91aa0a0870 11523-7418 HUMAN OTC DRUG Coppertone Tanning Defend and Glow SPF 15 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20.06; 100.3; 50.15; 50.15 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7419_5de442f1-fc7e-d030-e053-2a91aa0a30fc 11523-7419 HUMAN OTC DRUG Coppertone Water Babies SPF 50 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 30.8; 46.2; 102.8; 82.2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7420_5de0ba2d-10b5-4e5e-e053-2991aa0a25b0 11523-7420 HUMAN OTC DRUG Coppertone Ultra Guard SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer HealthCae LLC. HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 134.3; 26.86; 44.77; 89.53; 53.72 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7421_5f0c01cc-95c2-61e9-e053-2a91aa0a9008 11523-7421 HUMAN OTC DRUG Coppertone Sport SPF 15 Avobenzone, Octisalate, Octocrylene SPRAY TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.52; 37.17; 57.82 mg/g; mg/g; mg/g N 20181231 11523-7422_624694d2-ba2b-7260-e053-2991aa0a2d2b 11523-7422 HUMAN OTC DRUG Coppertone Sport SPF 30 avobenzone, octisalate, octocrylene, oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.25; 37.88; 58.93; 33.67 mg/g; mg/g; mg/g; mg/g N 20191231 11523-7423_5e09603a-508a-6e27-e053-2a91aa0a8f64 11523-7423 HUMAN OTC DRUG Coppertone Ultra Guard SPF 30 avobenzone, homosalate, octisalate, octocrylene and oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OXYBENZONE; OCTISALATE 85.87; 25.76; 17.17; 34.35; 42.94 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7424_5f8665a7-7e33-e152-e053-2a91aa0ab374 11523-7424 HUMAN OTC DRUG Coppertone Sport SPF 70 avobenzone, homosalate, octisalate, octocrylene, oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Bayer HelathCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.9; 134.5; 44.8; 89.7; 53.8 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7425_5e2e2432-1c94-2f1d-e053-2a91aa0a5510 11523-7425 HUMAN OTC DRUG Coppertone Ultra Guard SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.03; 86.76; 43.38; 34.7; 43.38 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7426_5e32fcff-d53f-98ad-e053-2991aa0a96f7 11523-7426 HUMAN OTC DRUG Coppertone Ultra Guard SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OXYBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 23.2; 15.4; 77.3; 34.8; 69.6 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7427_5f88b50e-239a-50c7-e053-2a91aa0acf87 11523-7427 HUMAN OTC DRUG Coppertone Sport SPF 100 avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. HOMOSALATE; OCTISALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 137.4; 45.8; 18.3; 91.6; 54.9; 27.4 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7428_6295715d-2dd9-7681-e053-2a91aa0a9817 11523-7428 HUMAN OTC DRUG Coppertone Kids SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE; OXYBENZONE 26.03; 43.38; 34.7; 86.76; 43.38 mg/g; mg/g; mg/g; mg/g; mg/g N 20191231 11523-7429_6293814b-35c6-5b74-e053-2991aa0a9ecc 11523-7429 HUMAN OTC DRUG Coppertone Kids Sport SPF 50 avobenzone, octisalate, octocrylene, oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 38.4; 76.9; 51.2; 25.6 mg/g; mg/g; mg/g; mg/g N 20191231 11523-7430_5ff2f67c-c8f4-2ba1-e053-2a91aa0a0e53 11523-7430 HUMAN OTC DRUG Coppertone Kids Sport SPF 100 avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; HOMOSALATE; OXYBENZONE 27.4; 18.3; 45.8; 91.6; 137.4; 54.9 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7431_5fc0569b-db1f-5ca6-e053-2a91aa0aba84 11523-7431 HUMAN OTC DRUG Coppertone Kids Wet Protect SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; HOMOSALATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE 26.73; 89.11; 44.56; 40.1; 80.2 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7432_5fc03f05-18f4-1bc0-e053-2a91aa0a368f 11523-7432 HUMAN OTC DRUG Coppertone Sport Wet Protect SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 87.74; 39.48; 43.87; 35.09; 26.32 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7433_5fd3abfe-416a-262a-e053-2991aa0a2655 11523-7433 HUMAN OTC DRUG Coppertone Waterbabies Pure and Simple Light SPF 50 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE 30.1; 45.1; 90.3; 90.3 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-7434_5ff2cd11-6906-634e-e053-2991aa0acca9 11523-7434 HUMAN OTC DRUG Coppertone Kids Sunscreen SPF 50 avobenzone, octocrylene, oxybenzone, octisalate, homosalate STICK TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 134.2; 26.8; 89.5; 44.7; 53.7 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 11523-7435_643e26cb-8cd5-3925-e053-2a91aa0a46b9 11523-7435 HUMAN OTC DRUG Coppertone Waterbabies Pure and Simple SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20180205 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE 45.1; 30.1; 90.3; 90.3 mg/g; mg/g; mg/g; mg/g N 20191231 11523-7436_636342f3-9a9e-ba62-e053-2a91aa0ace17 11523-7436 HUMAN OTC DRUG Coppertone Ultra Guard SPF 70 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 19990521 OTC MONOGRAPH NOT FINAL part352 Bayer HealthCare LLC. HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 153.15; 51.05; 102.1; 61.26; 30.63 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 11523-8002_626c3ee7-74c9-26cf-e053-2a91aa0acf6f 11523-8002 HUMAN OTC DRUG Coppertone Sport SPF 50 Coppertone Sport Aerosol Spray AEROSOL, SPRAY TOPICAL 20151101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. OCTISALATE; AVOBENZONE; OCTOCRYLENE; OXYBENZONE 34.92; 23.28; 69.83; 46.55 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 11523-8003_4987e688-4c61-2d5c-e054-00144ff8d46c 11523-8003 HUMAN OTC DRUG Coppertone Tanning Oil SPF 6 Homosalate, Oxybenzone SPRAY TOPICAL 20151101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. HOMOSALATE; OXYBENZONE 71.54; 26.83 mg/mL; mg/mL N 20181231 11523-8004_4987e688-4c74-2d5c-e054-00144ff8d46c 11523-8004 HUMAN OTC DRUG Coppertone Tanning Oil SPF 15 Avobenzoe, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20151101 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. OCTISALATE; OXYBENZONE; AVOBENZONE; HOMOSALATE 40.93; 27.28; 18.19; 90.95 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11523-8006_626c3ee7-74d7-26cf-e053-2a91aa0acf6f 11523-8006 HUMAN OTC DRUG Coppertone Sport SPF 70 Avobenzone LOTION TOPICAL 20140301 OTC MONOGRAPH FINAL part352 Bayer HealthCare LLC. OXYBENZONE; OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE 61.8; 51.5; 30.9; 133.9; 103 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 11527-016_74ed9f77-794b-4d84-b0d6-4d0bf3b809ee 11527-016 HUMAN OTC DRUG Dr. Sheffield Fluoride Anticavity Fluoride Anticavity Toothpaste PASTE, DENTIFRICE ORAL 20060102 OTC MONOGRAPH FINAL part355 Faria LLC dba Sheffield Pharmaceutcials SODIUM FLUORIDE 2.43 mg/g N 20181231 11527-051_ed1c4da6-6445-4a82-8121-722c2eda06ed 11527-051 HUMAN OTC DRUG Tolnaftate TOLNAFTATE CREAM TOPICAL 20091007 OTC MONOGRAPH FINAL part333C Faria Limited dba Sheffield Pharmaceuticals TOLNAFTATE 10 mg/g N 20181231 11527-052_78f14cb3-e7ae-4566-97e3-b20d030f7ffb 11527-052 HUMAN OTC DRUG Dr. Sheffield Hydrocortisone Anti itch Hydrocortisone CREAM TOPICAL 20070710 OTC MONOGRAPH NOT FINAL part348 Faria LLC dba Sheffield Pharmaceuticals HYDROCORTISONE 10 mg/g N 20181231 11527-056_9d4e21d2-c37a-452e-89bb-622f5fae725a 11527-056 HUMAN OTC DRUG Dr. Sheffield Hemorrhoid Zinc Oxide and Pramoxine Hydrochloride OINTMENT RECTAL 20121221 OTC MONOGRAPH FINAL part346 Sheffield Pharmaceuticals, LLC ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 125; 10 mg/g; mg/g N 20181231 11527-057_ccbdb264-e98c-49ff-89e7-392fc2a21381 11527-057 HUMAN OTC DRUG Dr Sheffield Muscle Rub Cream Muscle Rub Cream CREAM TOPICAL 20020424 OTC MONOGRAPH NOT FINAL part348 Faria LLC dba Sheffield Pharmaceuticals MENTHOL; METHYL SALICYLATE 100; 150 mg/g; mg/g N 20181231 11527-058_d3b3a363-bdea-41eb-b2c7-97035ddcaf49 11527-058 HUMAN OTC DRUG Dr. Sheffield Diaper Rash Zinc Oxide OINTMENT TOPICAL 20020109 OTC MONOGRAPH FINAL part347 Sheffield Pharmaceuticals, LLC ZINC OXIDE 400 mg/g N 20181231 11527-060_530d6170-b09a-40b8-a569-250f5383c0df 11527-060 HUMAN OTC DRUG Clear Zit Acne Treatment CREAM TOPICAL 20030203 OTC MONOGRAPH FINAL part333D Sheffield Pharmaceuticals LLC BENZOYL PEROXIDE 100 mg/g N 20181231 11527-061_b85ffec6-af96-4d35-b529-779cb2906135 11527-061 HUMAN OTC DRUG Sheffield Baby Teething Gel BENZOCAINE GEL ORAL 20030617 OTC MONOGRAPH NOT FINAL part356 Faria LLC dba Sheffield Pharmaceuticals BENZOCAINE 75 mg/g N 20181231 11527-062_597b7ed5-3464-481a-ad76-7db05e91f5f5 11527-062 HUMAN OTC DRUG Sheffield Pain Relief BENZOCAINE GEL ORAL 20060130 OTC MONOGRAPH NOT FINAL part356 Faria LLC dba Sheffield Pharmaceuticals BENZOCAINE 200 mg/g N 20181231 11527-069_630434a1-c9d6-4336-bca4-e1e9631da8ed 11527-069 HUMAN OTC DRUG Dr. Sheffield Anti Itch Cream Anti Itch Cream CREAM TOPICAL 20081111 OTC MONOGRAPH FINAL part347 Faria LLC dba Sheffield Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 11527-071_26002c54-7013-4187-80e3-65907591d9c4 11527-071 HUMAN OTC DRUG Dr Sheffield Athletes Foot CLOTRIMAZOLE CREAM TOPICAL 20041004 OTC MONOGRAPH FINAL part333C Faria Limited dba Sheffield Pharmaceuticals CLOTRIMAZOLE 10 mg/g N 20181231 11527-083_188bd230-d6a8-45b5-b1e7-4dce432f26ab 11527-083 HUMAN OTC DRUG Dr. Sheffield Vapor Cream Vapor Cream CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 Sheffield Pharmaceuticals LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 52; 12; 28 mg/g; mg/g; mg/g N 20181231 11527-089_65d48985-9a9f-47cd-8817-7143581ff38d 11527-089 HUMAN OTC DRUG Sheffield Arthritis and Muscle Pain Relief CAPSICUM OLEORESIN CREAM TOPICAL 20100414 OTC MONOGRAPH NOT FINAL part348 Faria LLC dba Sheffield Pharmaceuticals CAPSICUM OLEORESIN .25 mg/g N 20181231 11527-140_1deba1aa-2d0d-4fa4-b070-a208230007c2 11527-140 HUMAN OTC DRUG 12 Hour Original Nasal Decongestant Nasal Spray LIQUID NASAL 20140530 OTC MONOGRAPH FINAL part341 Faria LLC dba Sheffield Pharmaceutical OXYMETAZOLINE HYDROCHLORIDE 50 mg/100mL N 20181231 11527-161_517e9e9e-e549-4850-a4af-7f5d2d0aebb6 11527-161 HUMAN OTC DRUG Sheffield Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine Hydrochloride OINTMENT TOPICAL 20110123 OTC MONOGRAPH FINAL part333B Faria LLC dba Sheffield Pharmaceuticals BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE 500; 10000; 3.5; 10 [USP'U]/g; [USP'U]/g; mg/g; mg/g N 20181231 11527-162_7d91a3ae-8ede-4476-a349-4e8edae2fa67 11527-162 HUMAN OTC DRUG Sheffield Triple Antibiotic Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate OINTMENT TOPICAL 20110123 OTC MONOGRAPH FINAL part333B Faria LLC dba Sheffield Pharmaceuticals BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE 400; 5000; 3.5 [USP'U]/g; [USP'U]/g; mg/g N 20181231 11527-163_b186de04-6829-411d-9629-e3703f21c15b 11527-163 HUMAN OTC DRUG Sheffield Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20120925 OTC MONOGRAPH FINAL part333B Faria LLC dba Sheffield Pharmaceuticals BACITRACIN ZINC 500 [USP'U]/g N 20181231 11527-213_36d3f4b1-d455-4301-b113-94f910b3f573 11527-213 HUMAN OTC DRUG Dr. Sheffield Barrier Cream Barrier Cream CREAM TOPICAL 20170228 OTC MONOGRAPH FINAL part347 Sheffield Pharmaceuticals, LLC ZINC OXIDE; MENTHOL 200; 4.5 mg/g; mg/g N 20181231 11527-420_3a3eec12-0e1a-4bbf-8fbe-6aee69584593 11527-420 HUMAN OTC DRUG Dr. Sheffield Sensitive Care Sensitive Tooth Paste PASTE, DENTIFRICE ORAL 20170515 OTC MONOGRAPH NOT FINAL part356 Sheffield Pharmaceuticals LLC POTASSIUM NITRATE 50 mg/g N 20191231 11527-478_73e02081-ac53-41b5-b085-9428459deb1e 11527-478 HUMAN OTC DRUG Dr. Sheffield Psoriasis Medicated Moisturizer Psoriasis Medicated Moisturizer LOTION TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Faria LLC dba Sheffield Pharmaceuticals SALICYLIC ACID 20 mg/g N 20181231 11528-010_9f40fca2-0c26-4358-b28a-e2f78eacbed7 11528-010 HUMAN PRESCRIPTION DRUG COVARYX ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE TABLET, COATED ORAL 20070401 UNAPPROVED DRUG OTHER CENTRIX PHARMACEUTICAL, INC, ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE 1.25; 2.5 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 11528-020_9f40fca2-0c26-4358-b28a-e2f78eacbed7 11528-020 HUMAN PRESCRIPTION DRUG COVARYX HS ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE TABLET, COATED ORAL 20070401 UNAPPROVED DRUG OTHER CENTRIX PHARMACEUTICAL, INC, ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 11534-013_6be65bdd-e94a-4682-9977-043741174c59 11534-013 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET, DELAYED RELEASE ORAL 20050708 OTC MONOGRAPH NOT FINAL part334 Sunrise Pharmaceutical Inc BISACODYL 5 mg/1 N 20181231 11534-073_4a9520e4-2015-4055-a4e2-ec077a8b5f30 11534-073 HUMAN OTC DRUG Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20051226 OTC MONOGRAPH FINAL part343 Sunrise Pharmaceutical Inc ASPIRIN 81 mg/1 N 20181231 11534-090_dda29277-e3fb-4563-a038-53838c055ff4 11534-090 HUMAN OTC DRUG Senna and Docusate Sodium Senna and Docusate Sodium TABLET, FILM COATED ORAL 20070726 OTC MONOGRAPH NOT FINAL part334 Sunrise Pharmaceutical Inc DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 11534-134_d08a4708-1de9-4bf4-8444-80d8942995b8 11534-134 HUMAN OTC DRUG Senna and Docusate Sodium Senna and Docusate Sodium TABLET, FILM COATED ORAL 20070726 OTC MONOGRAPH NOT FINAL part334 Sunrise Pharmaceutical Inc DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 11534-155_5fdaba26-4c64-4896-a89a-69fefec6e563 11534-155 HUMAN OTC DRUG Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20100103 OTC MONOGRAPH FINAL part343 Sunrise Pharmaceutical Inc ASPIRIN 81 mg/1 N 20181231 11534-156_8f6065f1-bb7c-4422-8f81-e6da2e56b22d 11534-156 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET, DELAYED RELEASE ORAL 20050708 OTC MONOGRAPH NOT FINAL part334 Sunrise Pharmaceutical Inc BISACODYL 5 mg/1 N 20181231 11534-157_e4edc996-42df-4e94-aeee-69503c9a60e8 11534-157 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride phentermine hydrochloride CAPSULE ORAL 20170124 ANDA ANDA205019 SUNRISE PHARMACEUTICAL, INC. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 11534-159_59600473-2368-424d-9c89-4661a987b105 11534-159 HUMAN PRESCRIPTION DRUG Phentermine hydrochloride phentermine hydrochloride CAPSULE ORAL 20170124 ANDA ANDA205017 SUNRISE PHARMACEUTICAL, INC. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 11534-160_59600473-2368-424d-9c89-4661a987b105 11534-160 HUMAN PRESCRIPTION DRUG Phentermine hydrochloride phentermine hydrochloride TABLET ORAL 20170124 ANDA ANDA205008 SUNRISE PHARMACEUTICAL, INC. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 11534-164_252a4044-8b7f-4d7f-b501-3d089ca4bb5a 11534-164 HUMAN OTC DRUG Guiafenesin Guiafenesin TABLET ORAL 20050708 OTC MONOGRAPH FINAL part341 Sunrise Pharmaceutical Inc GUAIFENESIN 400 mg/1 N 20181231 11534-165_52ed30a7-f0bd-42d0-b581-e499e3bcfe7c 11534-165 HUMAN PRESCRIPTION DRUG FOLIC ACID folic acid TABLET ORAL 20150804 ANDA ANDA204418 SUNRISE PHARMACEUTICAL, INC. FOLIC ACID 1 mg/1 N 20181231 11534-166_6dc643f6-723c-4579-a8aa-f1d6efc48eb0 11534-166 HUMAN PRESCRIPTION DRUG SODIUM POLYSTYRENE SULFONATE sodium polystyrene sulfonate POWDER, FOR SUSPENSION ORAL; RECTAL 20170124 ANDA ANDA204071 SUNRISE PHARMACEUTICAL, INC. SODIUM POLYSTYRENE SULFONATE 4.1 meq/g N 20181231 11534-167_c1789516-29c5-4066-9f22-64ac9b7af355 11534-167 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE benztropine mesylate TABLET ORAL 20150715 ANDA ANDA204713 SUNRISE PHARMACEUTICAL, INC BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 11534-168_c1789516-29c5-4066-9f22-64ac9b7af355 11534-168 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE benztropine mesylate TABLET ORAL 20150715 ANDA ANDA204713 SUNRISE PHARMACEUTICAL, INC BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 11534-169_c1789516-29c5-4066-9f22-64ac9b7af355 11534-169 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE benztropine mesylate TABLET ORAL 20150715 ANDA ANDA204713 SUNRISE PHARMACEUTICAL, INC BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 11534-176_e4edc996-42df-4e94-aeee-69503c9a60e8 11534-176 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride phentermine hydrochloride CAPSULE ORAL 20170124 ANDA ANDA205019 SUNRISE PHARMACEUTICAL, INC. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 11534-180_2ffddd92-f91b-42cd-8fdb-467e5b169b84 11534-180 HUMAN OTC DRUG POLYETHYLENE GLYCOL 3350 NF polyethylene glycol 3350 POWDER, FOR SOLUTION ORAL 20170613 ANDA ANDA206105 SUNRISE PHARMACEUTICAL, INC POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 11534-187_2ae0eed4-d732-4087-a1d0-17684f6077ee 11534-187 HUMAN PRESCRIPTION DRUG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE butalbital, acetaminophen and caffeine CAPSULE ORAL 20170110 ANDA ANDA207118 SUNRISE PHARMACEUTICAL, INC ACETAMINOPHEN; CAFFEINE; BUTALBITAL 300; 40; 50 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 11559-001_64b58032-ce2b-4254-a9fa-8ce90d6d139a 11559-001 HUMAN OTC DRUG YOUTH DEW ROLL-ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 19770401 OTC MONOGRAPH FINAL part350 ESTEE LAUDER INC ALUMINUM CHLOROHYDRATE 20 mL/100mL N 20181231 11559-002_d191c825-628a-4a1f-80ef-8b85fb23166e 11559-002 HUMAN OTC DRUG MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY SPF 15 TITANIUM DIOXIDE CREAM TOPICAL 19990101 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 19.9 mL/100mL N 20181231 11559-003_64f94403-12d6-475a-8c97-fe164f4e2da9 11559-003 HUMAN OTC DRUG FUTURIST AGE RESISTING MAKEUP SPF 15 TITANIUM DIOXIDE LIQUID TOPICAL 19960901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE 2.2 mL/100mL E 20171231 11559-004_6be0a7e4-4ea4-4d4c-b518-bad45782b6fb 11559-004 HUMAN OTC DRUG CYBERWHITE EX EXTRA INTENSIVE BB CREME MULTI ACTION FORMULA SPF35 OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 4; 3.5; 2.5; 1.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 11559-006_143b26b6-7a07-41c3-9265-60128a9fdd20 11559-006 HUMAN OTC DRUG CYBER WHITE BRILLIANT CELLS FULL SPECTRUM BRIGHTENING UV PROTECTOR SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE, OXYBENZONE LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE 5; 5; 3; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 11559-007_05b1a435-8ea7-47b9-8c86-aa9d3f749584 11559-007 HUMAN OTC DRUG DAYWEAR ADVANCED MULTI-PROTECTION ANTIOXIDANT CREME SPF 15 FOR DRY SKIN OCTISALATE, AVOBENZONE, HOMOSALATE CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTISALATE; AVOBENZONE; HOMOSALATE 5; 3; 2 mL/100mL; mL/100mL; mL/100mL N 20181231 11559-008_7ad13077-5665-4406-9884-3aa20f3f2a86 11559-008 HUMAN OTC DRUG DAYWEAR SHEER TINT RELEASE ADVANCED MULTI-PROTECTION ANTI-OXIDANT MOISTURIZER SPF 15 OCTISALATE, AVOBENZONE LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTISALATE; AVOBENZONE 5; 3 mL/100mL; mL/100mL N 20181231 11559-009_7da066f7-4938-49cb-ba94-42268b068ae5 11559-009 HUMAN OTC DRUG DAYWEAR ADVANCED MULTIPROTECTION ANTIOXIDANT CREME SPF 15 FOR NORMAL COMBINATION SKIN OCTISALATE, AVOBENZONE CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTISALATE; AVOBENZONE 5; 3 mL/100mL; mL/100mL N 20181231 11559-010_fd8e22f2-cb7e-4462-8957-ab48e76403d3 11559-010 HUMAN OTC DRUG DAYWEAR ADVANCED MULTI-PROTECTION ANTIOXIDANT SPF 15 OILY SKIN OCTISALATE, AVOBENZONE, HOMOSALATE LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTISALATE; AVOBENZONE; HOMOSALATE 4.9; 3; 2 mL/100mL; mL/100mL; mL/100mL N 20181231 11559-011_61256a00-2974-4f15-977f-47cc7aafb4f7 11559-011 HUMAN OTC DRUG RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK CREME SPF 15 NML COMBO OCTINOXATE, OCTISALATE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE 7.5; 3.5 mL/100mL; mL/100mL E 20171231 11559-012_fa9febfb-6fbc-43a6-b37e-f35d08984f4b 11559-012 HUMAN OTC DRUG RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK SPF15 FOR DRY SKIN OCINOXATE CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE 7.5 mL/100mL E 20171231 11559-013_a5160066-95d9-4184-9452-bd120e3d66fe 11559-013 HUMAN OTC DRUG RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK SPF15 NORMAL COMBO SKIN OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE 7.5; 1.4 mL/100mL; mL/100mL E 20171231 11559-014_b1fe154e-ce61-4912-a867-3cb86894ff4e 11559-014 HUMAN OTC DRUG DOUBLE WEAR MINERAL RICH LOOSE POWDER MAKEUP SPF 12 TITANIUM DIOXIDE POWDER TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 2.2 g/100g N 20181231 11559-015_07be7bfd-5feb-4481-9559-4e6d4b556212 11559-015 HUMAN OTC DRUG DAYWEAR BB ANTI OXIDANT BEAUTY BENEFIT BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 4; 2.5; 1.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 11559-017_041b854b-9555-4aa2-bcca-badf10d5886f 11559-017 HUMAN OTC DRUG RE NUTRIV RADIANT UV BASE BROAD SPECTRUM SPF 50 HOMOSALATE , OCTYL SALICYLATE, AVOBENZONE, OXYBENZONE, OCTOCRYLENE LOTION TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE 5; 5; 3; 3; 2.7 mL/100mL; mL/100mL; mL/100mL; nmol/100mL; mL/100mL N 20181231 11559-018_a37db316-79dd-47d1-a05a-e86643cc9fe7 11559-018 HUMAN OTC DRUG RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20101012 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTISALATE; OCTOCRYLENE .0312; .052; .02808 g/mL; g/mL; g/mL N 20181231 11559-020_525face8-dc5d-4ba4-a682-1beb6322ed5a 11559-020 HUMAN OTC DRUG ADVANCED TIME ZONE AGE REVERSING LINE WRINKLE BROAD SPECTRUM SPF 15 DRY SKIN AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 2.7 mL/100mL; mL/100mL; mL/100mL N 20181231 11559-021_2c8d36a1-5545-4ce8-b066-eb011dba96d0 11559-021 HUMAN OTC DRUG ADVANCED TIME ZONE AGE REVERSING LINE WRINKLE BROAD SPECTRUM SPF 15 NORMAL COMBO SKIN AVOBENZONE, OCTINOXATE, and OCTISALATE CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 mL/100mL; mL/100mL; mL/100mL N 20181231 11559-023_b57817b0-4258-4e1e-8ae8-4d57a2e1e59c 11559-023 HUMAN OTC DRUG DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT OIL-FREE BROAD SPECTRUM SPF 25 AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTISALATE; OCTOCRYLENE .0303; .0505; .02727 g/mL; g/mL; g/mL N 20181231 11559-025_2dbf753b-4b6c-4d0a-96c5-fe63ff27f224 11559-025 HUMAN OTC DRUG RESILIENCE LIFT FIRMING/SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 NML/COMBO OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE .0765; .01734 g/100mL; g/100mL N 20181231 11559-026_ae5066bd-3f04-4c6e-a06a-4897f3de9910 11559-026 HUMAN OTC DRUG DAY WEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT AND UV DEFENSE BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20121107 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0312; .052; .052; .02808; .0312 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 11559-028_df40ee7a-d73a-493a-a7b4-2d4ae1f4c8e2 11559-028 HUMAN OTC DRUG RESILIENCE LIFT FIRMING- SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 FOR DRY SKIN AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTISALATE; OCTOCRYLENE .03; .05; .027 g/mL; g/mL; g/mL N 20181231 11559-029_c96cc1d5-acfd-4ed4-8e0d-584cf3d95bb1 11559-029 HUMAN OTC DRUG RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 NML COMBO AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTISALATE; OCTOCRYLENE .0303; .0505; .2727 g/mL; g/mL; g/mL N 20181231 11559-035_ef289056-5aba-4dec-a870-4add0d46e503 11559-035 HUMAN OTC DRUG ADVANCED TIME ZONE AGE REVERSING LINE/WRINKLE OIL FREE BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN AVOBENZONE, OCTINOXATE, and OCTISALATE CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; OCTINOXATE; OCTISALATE .03; .075; .05 g/mL; g/mL; g/mL N 20181231 11559-036_997ffe0a-d54d-47c4-a5cc-85dee36c725f 11559-036 HUMAN OTC DRUG DOUBLE WEAR STAY IN PLACE HIGH COVER CONCEALER BROAD SPECTRUM SPF 35 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE 4.9; 1.9 g/100g; g/100g N 20181231 11559-037_92fd4bbc-9326-4d73-af81-82a37cdd3b73 11559-037 HUMAN OTC DRUG CYBERWHITE HD UV PROTECTOR BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0309; .0515; .0515; .0278; .0309 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 11559-038_33e1e5b5-c66a-49b4-942c-79f2cb9b9801 11559-038 HUMAN OTC DRUG DOUBLE WEAR ALL DAY GLOW BB MOISTURE MAKEUP BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .085125; .05675; .05902; .03632 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 11559-039_487e60e5-20ff-454a-a3c4-d605c2cc54ef 11559-039 HUMAN OTC DRUG CLEAR DIFFERENCE BB COMPLEXION PERFECTING BB BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .08175; .0436; .02725; .01199 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 11559-040_aaad7c1d-3166-4a2b-9625-6edf325c2d46 11559-040 HUMAN OTC DRUG CYBERWHITE HD BB ADVANCED BRIGHTENING BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0309; .0515; .0515; .0278; .0309 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 11559-041_74e68426-cad7-4cf4-89c7-564e5d95b94a 11559-041 HUMAN OTC DRUG CLEAR DIFFERENCE ADVANCED BLEMISH SERUM SALICYLIC ACID LOTION TOPICAL 20140401 OTC MONOGRAPH FINAL part333D ESTEE LAUDER INC SALICYLIC ACID .0053 g/100mL N 20181231 11559-042_d798293b-82a2-4dd4-9aeb-dd66fae5161b 11559-042 HUMAN OTC DRUG Perfectionist Youth-Infusing Makeup Broad Spectrum SPF 25 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE .0795; .02014 g/100mL; g/100mL N 20181231 11559-043_e770a05f-3e65-4047-9e14-aad256cdc0d8 11559-043 HUMAN OTC DRUG ENLIGHTEN EE EVEN EFFECT SKIN TONE CORRECTOR SPF BROAD SPECTRUM SPF 30 HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, and TITANIUM DIOXIDE LOTION TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .0315; .0315; .02835; .0315; .01995 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 11559-044_8cee12b1-2d09-43dc-964d-92cd6c0cb5e2 11559-044 HUMAN OTC DRUG CLEAR DIFFERENCE TARGETED BLEMISH TREATMENT SALICYLIC ACID LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part333D ESTEE LAUDER INC SALICYLIC ACID .0091 g/100mL N 20181231 11559-045_980434ae-22f8-4a9e-a9a3-28250722b53e 11559-045 HUMAN OTC DRUG CRESCENT WHITE UV PROTECTOR BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20150209 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0309; .0515; .0515; .0278; .0309 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 11559-047_dfed1a7b-a43e-4eda-a73f-24bb5beb8bfd 11559-047 HUMAN OTC DRUG DOUBLE WEAR CUSHION BB ALL DAY WEAR COMPACT BROAD SPECTRUM SPF 50 TITANIUM DIOXIDE and ZINC OXIDE PASTE TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE; ZINC OXIDE 7.6; 5.1 g/100g; g/100g N 20181231 11559-048_b1c69374-229c-4795-b424-a62bcb934b42 11559-048 HUMAN OTC DRUG DOUBLE WEAR NUDE WATER FRESH MAKEUP BROAD SPECTRUM SPF 30 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .056; .035; .025 g/mL; g/mL; g/mL N 20181231 11559-720_7d3ee599-4b0a-470b-a054-99978b5f37c8 11559-720 HUMAN OTC DRUG RESILIENCE LIFT EXTREME CREME COMPACT MAKEUP SPF 15 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE 5; 2 g/100g; g/100g N 20181231 11559-722_aa70c32e-32e4-42f5-86d8-15ed91feab81 11559-722 HUMAN OTC DRUG DOUBLE WEAR LIGHT STAY IN PLACE MAKEUP SPF 10 TITANIUM DIOXIDE LIQUID TOPICAL 20070901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC. TITANIUM DIOXIDE 5 mL/100mL E 20171231 11559-724_32e26906-5a70-461c-81fd-a1b76939df66 11559-724 HUMAN OTC DRUG RE-NUTRIV ULTIMATE LIFTING MAKEUP SPF15 TITANIUM DIOXIDE CREAM TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 1.4 mL/100mL N 20181231 11559-725_ead5a455-5fe0-460e-8e8e-6db71d2d49bd 11559-725 HUMAN OTC DRUG LIP CONDITIONER SPF 15 OCTINOXATE LIPSTICK TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE 3.5 g/100g E 20171231 11559-727_03f45157-ff4a-41c9-9e29-c932aaeac539 11559-727 HUMAN OTC DRUG NUTRITIOUS VITA MINERAL LOOSE POWDER MAKEUP SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 2.1 g/100g E 20171231 11559-728_ad2d5eca-9665-4aec-868a-ab0640843622 11559-728 HUMAN OTC DRUG TIME ZONE LINE AND WRINKLE REDUCING CREME SPF 15 FOR DRY SKIN OCTSALATE, AVOBENZONE CREAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTISALATE; AVOBENZONE 5; 3 mL/100mL; mL/100mL N 20181231 11559-729_d35449cf-3329-4773-980d-4230a255feae 11559-729 HUMAN OTC DRUG DOUBLE WEAR STAY IN PLACE SPF 10 MAKEUP TITANIUM DIOXIDE POWDER TOPICAL 20070301 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 4 g/100g E 20171231 11559-732_12db5263-21be-4350-9165-8e83a41f5067 11559-732 HUMAN OTC DRUG DOUBLE MATTE OIL CONTROL MAKEUP SPF 15 OCTINOXATE LIQUID TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part352 Estee Lauder Inc. OCTINOXATE 2.2 mL/100mL E 20171231 11559-736_57bb13de-f970-4ea2-aa61-d31b15527599 11559-736 HUMAN OTC DRUG EQUALIZER SMART MAKEUP SPF 10 TITANIUM DIOXIDE LOTION TOPICAL 20081226 OTC MONOGRAPH NOT FINAL part352 Estee Lauder Inc. TITANIUM DIOXIDE 2 mL/100mL E 20171231 11559-737_c1f40cf7-0c05-4f20-b8a7-63056e305da7 11559-737 HUMAN OTC DRUG TIME ZONE LINE AND WRINKLE REDUCING CREME SPF 15 NORMAL COMBO SKIN OCTINOXATE, OCTSALATE, AVOBENZONE CREAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 mL/100mL; mL/100mL; mL/100mL N 20181231 11559-739_32c86997-5bf8-416c-b960-c9ec038bef51 11559-739 HUMAN OTC DRUG NUTRITIOUS VITA-MINERAL MAKEUP SPF 10 TITANIUM DIOXIDE LIQUID TOPICAL 20081122 OTC MONOGRAPH NOT FINAL part352 Estee Lauder Inc. TITANIUM DIOXIDE 2.4 mL/100mL E 20171231 11559-746_8a53c88e-f816-48da-b647-13b847afe0fe 11559-746 HUMAN OTC DRUG RENUTRIV ULTIMATE RADIANCE MAKEUP SPF 15 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; TITANIUM DIOXIDE 2.2; 1.4 mL/100mL; mL/100mL N 20181231 11559-754_292e7622-c056-4857-b37e-76ff2a5a86df 11559-754 HUMAN OTC DRUG DAYWEAR PLUS MULTI PROTECTION TINTED MOISTURIZER SPF 15 OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 2 mL/100mL; mL/100mL; mL/100mL E 20171231 11559-769_b15b2cb1-51f7-453d-b500-ea0a00851eec 11559-769 HUMAN OTC DRUG RE-NUTRIV INTENSIVE LIFTNG MAKE UP SPF15 TITANIUM DIOXIDE CREAM TOPICAL 19991201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 1.4 mL/100mL N 20181231 11559-932_3a086eeb-c2ea-4c86-b64d-03da38c5dd89 11559-932 HUMAN OTC DRUG RESILIENCE LIFT EXTREME ULTRA FIRMING SPF 15 OCTINOXATE, OCTISALATE CREAM TOPICAL 20080501 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC OCTINOXATE; OCTISALATE 7.5; 3.5 mL/100mL; mL/100mL E 20171231 11559-945_25abe3f5-42f2-470e-945c-bc5169461477 11559-945 HUMAN OTC DRUG DOUBLE WEAR STAY IN PLACE MAKEUP SPF 10 TITANIUM DIOXIDE LIQUID TOPICAL 19961201 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC. TITANIUM DIOXIDE 1 mL/100mL E 20171231 11559-967_3a358da9-9164-4d82-bfb1-22404908013b 11559-967 HUMAN OTC DRUG Resilience Lift Extreme Radiant Lifting Makeup SPF 15 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20060601 OTC MONOGRAPH NOT FINAL part352 Estee Lauder Inc. OCTINOXATE; TITANIUM DIOXIDE 4.2; 1 mL/100mL; mL/100mL N 20181231 11559-969_2a2f19e4-d8c1-4e3a-bcce-48877f01b078 11559-969 HUMAN OTC DRUG DOUBLE WEAR STAY IN PLACE CONCEALER SPF 10 TITANIUM DIOXIDE LIQUID TOPICAL 19981001 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER INC TITANIUM DIOXIDE 4.2 mL/100mL E 20171231 11564-001_0c1b7250-6222-4f3f-9a21-f7ee9c8f80bc 11564-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830101 NDA NDA205889 Fresno Oxygen & Welding Suppliers Inc OXYGEN 992 mL/L N 20181231 11564-002_36e8541a-78d1-4647-a514-8eaf849c81e0 11564-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20050101 NDA NDA205891 Fresno Oxygen & Welding Suppliers Inc NITROGEN 992 mL/L N 20181231 11564-003_2bf9a5b1-2088-4728-9514-550285744230 11564-003 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20050101 UNAPPROVED MEDICAL GAS Fresno Oxygen and Welding Suppliers AIR 1000 mL/L E 20171231 11564-004_60cc84f6-e43f-e063-e053-2a91aa0a6b85 11564-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20050101 NDA NDA205889 Fresno Oxygen and Welding Suppliers, Inc. OXYGEN 210 mL/L N 20181231 11584-0030_5d5ec2cc-3ef2-4b98-8356-52dee0a73b5a 11584-0030 HUMAN PRESCRIPTION DRUG Tencon butalbital and acetaminophen TABLET ORAL 20131010 ANDA ANDA089987 International Ethical Labs, Inc. BUTALBITAL; ACETAMINOPHEN 50; 325 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 11584-1032_2e6a4425-38e6-4fb4-950c-5769412d8721 11584-1032 HUMAN OTC DRUG DESPEC Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20020402 OTC MONOGRAPH FINAL part341 International Ethical Laboratories, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 100; 5 mg/5mL; mg/5mL E 20171231 11584-1046_aeb2682a-f929-4299-8ba4-195daf73310d 11584-1046 HUMAN OTC DRUG DESPEC DM Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SYRUP ORAL 20140102 OTC MONOGRAPH FINAL part341 International Ethical Laboratories, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 11584-1081_182bf15d-41f8-3651-e054-00144ff8d46c 11584-1081 HUMAN OTC DRUG Despec-Tab Guaifenesin, Pseudoephedrine Hydrochloride TABLET ORAL 20140825 OTC MONOGRAPH FINAL part341 International Ethical Labs GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 11584-1101_18043cd4-1063-6059-e054-00144ff88e88 11584-1101 HUMAN OTC DRUG Despec-DM Tabs Dextromethorphan Hydrobomide, Guaifenesin, Pseudoephedrine Hydrochloride TABLET ORAL 20140825 OTC MONOGRAPH FINAL part341 Internatiional Ethical Labs GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 200; 30; 10 mg/1; mg/1; mg/1 N 20181231 11584-1110_29ff4568-9a18-4e96-8c89-944880bd385e 11584-1110 HUMAN OTC DRUG Despec EDA Drops Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20120119 OTC MONOGRAPH FINAL part341 International Ethical Labs DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/mL; mg/mL; mg/mL E 20171231 11584-4770_bd7da0dd-94d7-43ff-9463-88e68ef09c70 11584-4770 HUMAN OTC DRUG Relagesic Acetaminophen and Phenyltoloxamine Citrate TABLET ORAL 20150215 OTC MONOGRAPH NOT FINAL part343 International Ethical Labs. ACETAMINOPHEN; PHENYLTOLOXAMINE CITRATE 500; 29 mg/1; mg/1 E 20171231 11649-0001_f279668e-7c60-4ba8-b683-0651c02455c3 11649-0001 HUMAN OTC DRUG Epsal Magnesium Sulfate, Unspecified Form OINTMENT TOPICAL 19570115 OTC MONOGRAPH NOT FINAL part334 Press Chemical and Pharmaceutical Laboratories MAGNESIUM SULFATE, UNSPECIFIED FORM 400 mg/g N 20181231 11673-000_f1813b03-bbc3-44d8-b2ae-4d38e5a7d319 11673-000 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20100707 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 11673-001_1649cc23-5365-4509-9ce0-78eafda342a0 11673-001 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20120806 OTC MONOGRAPH NOT FINAL part333A Target Corp TRICLOSAN .46 mg/mL N 20181231 11673-002_73933cde-8b56-4d7d-a277-8d4f037a73fc 11673-002 HUMAN OTC DRUG up and up ready to use enema Dibasic sodium phosphate, Monobasic sodium phosphate ENEMA RECTAL 20120126 OTC MONOGRAPH NOT FINAL part334 Target Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 11673-003_30bfb5d6-ad6e-414b-8b6a-c00eb593ce51 11673-003 HUMAN OTC DRUG First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20120308 OTC MONOGRAPH NOT FINAL part333E Target Corporation POVIDONE-IODINE 10 mg/mL N 20181231 11673-004_2a839450-7d82-455a-a0ef-39906fd2e37d 11673-004 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20110826 OTC MONOGRAPH FINAL part355 Target Corp SODIUM FLUORIDE 10.4 mg/mL N 20191231 11673-005_97e692f0-4a54-4ee5-b72b-7f977b62548f 11673-005 HUMAN OTC DRUG up and up digestive relief Bismuth subsalicylate SUSPENSION ORAL 20150310 OTC MONOGRAPH FINAL part335 Target Corporation BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 11673-006_b8820e65-4591-43c3-b27d-3d9034c9fe97 11673-006 HUMAN OTC DRUG up and up fast mucus relief severe cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20150316 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 11673-007_ac8f0004-08b0-4628-b5dd-74dd76f494b5 11673-007 HUMAN OTC DRUG up and up famotidine complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20150427 ANDA ANDA077355 Target Corporation FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 11673-010_f4aed401-5f10-4d5d-9f96-301bfd5e46ca 11673-010 HUMAN OTC DRUG up and up famotidine complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20150506 ANDA ANDA077355 Target Corporation FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 11673-011_d310642b-fca2-4ac5-a854-2296f8796fd3 11673-011 HUMAN OTC DRUG 2 in 1 Pyrithione zinc SHAMPOO TOPICAL 20130516 OTC MONOGRAPH FINAL part358H Target Corporation PYRITHIONE ZINC 10.4 mg/mL N 20181231 11673-012_d928fc60-4136-4373-b3f0-6d2cb1b35278 11673-012 HUMAN OTC DRUG up and up severe cold and flu nighttime Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20150803 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 11673-012_f98d1d54-8e11-4bb1-825a-ab5447d37847 11673-012 HUMAN OTC DRUG up and up childrens allergy melts Diphenhydramine HCl TABLET, CHEWABLE ORAL 20151110 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20181231 11673-014_d66c836c-4dac-49dd-82d7-303a1dcfe2e3 11673-014 HUMAN OTC DRUG up and up dm max cough plus chest congestion Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20150312 OTC MONOGRAPH FINAL part341 Target Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 11673-015_a2579ed7-4f9b-49ff-86a9-e5606fe1806b 11673-015 HUMAN OTC DRUG Healing petrolatum OINTMENT TOPICAL 20100107 OTC MONOGRAPH FINAL part347 Target Corporation PETROLATUM 340 mg/g N 20181231 11673-016_94be1235-907e-4419-9a7b-0c67f85daaae 11673-016 HUMAN OTC DRUG Athletes Foot Butenafine Hydrochloride CREAM TOPICAL 20171117 ANDA ANDA205181 Target Corporation BUTENAFINE HYDROCHLORIDE 10 mg/g N 20181231 11673-017_2b6e3664-4f5f-4628-b60d-4e7192df659d 11673-017 HUMAN OTC DRUG up and up hydrocortisone hydrocortisone OINTMENT TOPICAL 20150416 OTC MONOGRAPH NOT FINAL part348 Target Corporation HYDROCORTISONE 1 g/100g N 20181231 11673-018_ad559750-6af8-4727-b36c-a8dea5b9a380 11673-018 HUMAN OTC DRUG up and up omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150417 NDA NDA022032 Target Corporation OMEPRAZOLE 20 mg/1 N 20181231 11673-019_a4c1e494-9aba-42b2-932f-69e3ad1e9756 11673-019 HUMAN OTC DRUG up and up nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20150310 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 11673-020_1a07760d-d7a8-4805-bd86-37df6f0b1166 11673-020 HUMAN OTC DRUG Diaper Rash ZINC OXIDE PASTE TOPICAL 20080324 OTC MONOGRAPH FINAL part347 Target Corporation ZINC OXIDE 532 mg/g N 20181231 11673-021_f1fafaf4-70bf-4089-8571-175b83579316 11673-021 HUMAN OTC DRUG Up and Up Daytime Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20150313 OTC MONOGRAPH FINAL part341 Target Corporation N 20181231 11673-023_1b7cae38-6690-432b-a3fc-10dc1e3d920d 11673-023 HUMAN OTC DRUG up and up ranitidine Ranitidine TABLET, FILM COATED ORAL 20150401 ANDA ANDA091429 Target Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 11673-025_d5c644d3-19de-4ab9-910c-c24acb3646c2 11673-025 HUMAN OTC DRUG up and up antibiotic plus pain relief Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20150415 OTC MONOGRAPH FINAL part333B Target Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 11673-027_57e16f70-b23f-4989-b21a-5d1ccdc6409d 11673-027 HUMAN OTC DRUG Aspirin Enteric Safety-Coated Aspirin TABLET ORAL 20130308 OTC MONOGRAPH FINAL part343 TARGET Corporation ASPIRIN 81 mg/1 N 20181231 11673-029_818c15d4-9dfc-4522-a810-16111e6408c2 11673-029 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20100311 ANDA ANDA076775 Target Corporation NICOTINE 2 mg/1 N 20181231 11673-030_ff9c2243-9c95-4a9f-9c67-32015c31579a 11673-030 HUMAN OTC DRUG up and up hydrocortisone one per cent Hydrocortisone CREAM TOPICAL 20150409 OTC MONOGRAPH NOT FINAL part348 Target Corporation HYDROCORTISONE 1 g/100g N 20181231 11673-031_0d6f2ac0-295e-47ce-aedb-8cadc1e66a63 11673-031 HUMAN OTC DRUG up and up famotidine Famotidine TABLET ORAL 20150313 ANDA ANDA075400 Target Corporation FAMOTIDINE 10 mg/1 N 20181231 11673-032_dfc91b7a-ba7d-32f7-8ade-15541094d5ae 11673-032 HUMAN OTC DRUG Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE ORAL 20150327 ANDA ANDA076667 Target Brands Inc. FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 N 20181231 11673-034_3f35fe37-3ba1-4835-bfa0-5e848bea04bc 11673-034 HUMAN OTC DRUG Mineral oil Mineral oil OIL ORAL 20150228 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation MINERAL OIL 100 mg/100mL E 20171231 11673-035_40bb2597-4c27-1cc8-e054-00144ff88e88 11673-035 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20160503 OTC MONOGRAPH FINAL part341 Target MENTHOL 5.8 mg/1 N 20191231 11673-035_63eb6bc6-b443-eb4b-e053-2991aa0a8191 11673-035 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20180129 OTC MONOGRAPH FINAL part341 Target Corporation MENTHOL 5.8 mg/1 N 20191231 11673-036_40bb563e-d4ea-21ad-e054-00144ff88e88 11673-036 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20160503 OTC MONOGRAPH FINAL part341 Target MENTHOL 7.5 mg/1 N 20181231 11673-036_60b6f0b6-fd2e-e8f1-e053-2a91aa0ae52e 11673-036 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20160504 OTC MONOGRAPH FINAL part341 Target Corporation MENTHOL 7.5 mg/1 N 20181231 11673-037_63ee8ac6-5af5-54b3-e053-2a91aa0afb74 11673-037 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20180129 OTC MONOGRAPH FINAL part341 Target Corporation MENTHOL 5.8 mg/1 N 20191231 11673-038_63ecb1d2-bcd0-281f-e053-2a91aa0ac416 11673-038 HUMAN OTC DRUG Cherry Antacid Soft Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20180129 OTC MONOGRAPH FINAL part331 Target CALCIUM CARBONATE 1177 mg/1 N 20191231 11673-039_67d8e4d3-28d5-490e-8d00-3dec298b1ace 11673-039 HUMAN OTC DRUG Childrens Allergy Dye Free Loratadine LIQUID ORAL 20141031 ANDA ANDA077421 TARGET Corporation LORATADINE 5 mg/5mL N 20181231 11673-040_60b77ff7-5ebd-2d5e-e053-2a91aa0a9ac7 11673-040 HUMAN OTC DRUG Assorted Fruit Antacid Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20151204 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 11673-041_4627e47c-7eeb-48b9-9e3f-0517332d7d1b 11673-041 HUMAN OTC DRUG Target Cold/Flu Relief acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090709 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 11673-042_63f05c14-a974-7ca7-e053-2a91aa0a8f1a 11673-042 HUMAN OTC DRUG Antacid Strawberry Relief Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20180129 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 N 20191231 11673-043_63eec93c-16ae-7b0d-e053-2a91aa0a4ec5 11673-043 HUMAN OTC DRUG Antacid Strawberry Relief Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20180129 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 N 20191231 11673-048_29d3b18a-0ed3-4880-83cc-7c9c80b7bc8c 11673-048 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20150228 ANDA ANDA078682 TARGET Corporation IBUPROFEN 200 mg/1 E 20171231 11673-050_4c1f031a-f319-4833-90be-ba6344166c99 11673-050 HUMAN OTC DRUG up and up ibuprofen pm diphenhydramine citrate and ibuprofen TABLET, FILM COATED ORAL 20090710 ANDA ANDA079113 Target Corporation DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 11673-053_ad81377a-986b-4a2e-bacd-7573565700fe 11673-053 HUMAN OTC DRUG Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20170228 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation BISACODYL 5 mg/1 N 20181231 11673-055_0915af59-99e2-43ff-8adc-3fe750ff0f1b 11673-055 HUMAN OTC DRUG moist wipes fresh scent Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Target Corp BENZALKONIUM CHLORIDE .115 g/1 N 20181231 11673-057_37afe6da-17d6-4254-9e22-89db7de236fe 11673-057 HUMAN OTC DRUG up and up hydrocortisone hydrocortisone CREAM TOPICAL 20150407 OTC MONOGRAPH NOT FINAL part348 Target Corporation HYDROCORTISONE 1 g/100g N 20181231 11673-059_4324a07a-bbd1-4270-a0a6-2206266c080d 11673-059 HUMAN OTC DRUG Daytime Cold and Cough and NightTime Cold and Congestion Childrens Brompheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl, Phenylephrine HCl KIT 20150731 OTC MONOGRAPH FINAL part341 TARGET Corporation N 20181231 11673-061_605dc450-aaed-41f2-b2fb-a7a13978024f 11673-061 HUMAN OTC DRUG up and up famotidine Famotidine TABLET ORAL 20120503 ANDA ANDA077351 Target Corporation FAMOTIDINE 20 mg/1 N 20181231 11673-063_e039e35f-1caa-4d31-8c57-1660ff86dc16 11673-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19971126 OTC MONOGRAPH FINAL part347 Target Corporation FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 11673-069_cbbf9fe6-ff1a-4dd4-abd0-8b057070f934 11673-069 HUMAN OTC DRUG Pure petroleum White Petrolatum JELLY TOPICAL 20050602 OTC MONOGRAPH FINAL part347 Target Corp PETROLATUM 1 g/g N 20181231 11673-071_2f72578a-290a-48da-bbc4-647124c93770 11673-071 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part333A target Corp ALCOHOL 567 mg/mL N 20181231 11673-072_4bc7cec0-4c19-4258-8245-82a2f1089e77 11673-072 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19960108 OTC MONOGRAPH NOT FINAL part356 Target Corp EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11673-073_62e951c0-2ea8-4caa-b436-447a6532eef3 11673-073 HUMAN OTC DRUG up and up first aid antibiotic Bacitracin OINTMENT TOPICAL 20150406 OTC MONOGRAPH FINAL part333B Target Corporation BACITRACIN 500 [USP'U]/g N 20181231 11673-077_71984856-fba2-40db-98e6-7b2ce9291309 11673-077 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20180111 OTC MONOGRAPH NOT FINAL part333A TARGET Corporation ISOPROPYL ALCOHOL 91 mL/100mL N 20191231 11673-080_7e501100-85aa-49a4-9d28-24c8627cfb1b 11673-080 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Target Corporation TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 11673-081_9d9fee94-f93d-4d28-bc81-383b584ae961 11673-081 HUMAN OTC DRUG Up and Up Miconazole 3 Miconazole nitrate KIT 20090817 ANDA ANDA075329 Target Corporation N 20181231 11673-084_533abe62-c75f-4fe7-87cd-bb2d90d1c0ec 11673-084 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20141231 OTC MONOGRAPH NOT FINAL part343 TARGET Corporation ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 11673-086_09754896-933a-4277-8059-70ea92c67e53 11673-086 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140314 OTC MONOGRAPH NOT FINAL part333A Target Corp ALCOHOL 567 mg/mL N 20181231 11673-090_41c6aba0-2439-4a0f-9c28-640ee449d98d 11673-090 HUMAN OTC DRUG Up and UP Anticavity Toothpaste Whitening Plus Mouthwash Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110531 OTC MONOGRAPH FINAL part355 Target Corporation SODIUM FLUORIDE 2.43 mg/g E 20171231 11673-092_b5fadc76-6bfe-48ef-97f0-fc8b7b33e524 11673-092 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Target Corporation LORATADINE 5 mg/5mL N 20181231 11673-095_1cf5123e-48f0-4c17-a8ca-5f111d451e94 11673-095 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate Magnesium sulfate GRANULE ORAL; TOPICAL 20170831 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation MAGNESIUM SULFATE, UNSPECIFIED 1 g/g N 20181231 11673-098_2877d530-357e-4c24-836d-2cb996c32457 11673-098 HUMAN OTC DRUG Up and Up Medicated Hemorrhoidal Pads WITCH HAZEL SWAB TOPICAL 20111113 OTC MONOGRAPH FINAL part346 TARGET CORPORATION WITCH HAZEL 1 g/1 E 20171231 11673-099_30a12c7e-0d59-46c2-a104-c835f81bfab9 11673-099 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20140406 OTC MONOGRAPH NOT FINAL part333A Target Corporation BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 11673-102_14692d83-36df-49a7-a2ad-7c9987ef4be1 11673-102 HUMAN OTC DRUG Target Childrens All Day Allergy Relief Sugar Free Grape Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Target Corporation CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 11673-103_df95506b-01e1-4a68-a613-1a9d8fc5be07 11673-103 HUMAN OTC DRUG Up and Up Allergy Relief Nasal Fluticasone propionate SPRAY, METERED NASAL 20160531 ANDA ANDA207957 Target Corporation FLUTICASONE PROPIONATE 50 ug/1 N 20181231 11673-105_977e881d-5bb1-4e7e-b1fc-6f57852550a7 11673-105 HUMAN OTC DRUG Up and Up childrens acetaminophen Acetaminophen SUSPENSION ORAL 20090708 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 11673-106_3d7eb25d-fe73-4084-b859-9e15cde547ba 11673-106 HUMAN OTC DRUG up and up childrens all day allergy relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Target Corporation CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 11673-107_fd24db6f-21d5-4001-a5b3-4dd6e921cf07 11673-107 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20131130 OTC MONOGRAPH FINAL part341 TARGET Corporation GUAIFENESIN 400 mg/1 N 20181231 11673-108_dd9b10fa-539b-427f-bdec-bae5e46de014 11673-108 HUMAN OTC DRUG up and up acetaminophen acetaminophen CAPSULE, LIQUID FILLED ORAL 20160316 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 325 mg/1 N 20181231 11673-109_818ca5eb-50db-4af2-8783-ec8b6da63c16 11673-109 HUMAN OTC DRUG Mucus and Cough Relief Dextromethorphan Hydrobromide and Guaifenesin TABLET ORAL 20131130 OTC MONOGRAPH FINAL part341 TARGET Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 11673-112_f538238e-b54a-4092-9579-f2ff2bf9f420 11673-112 HUMAN OTC DRUG up and up sinus 12 hour Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150313 ANDA ANDA075153 Target Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 11673-113_8e7a26af-db1f-4441-b58c-aebd1324637c 11673-113 HUMAN OTC DRUG up and up nighttime flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 11673-114_4d1d9eb3-f04f-4d08-a7ac-36b21d5ab261 11673-114 HUMAN OTC DRUG up and up 12 hour cough relief dextromethorphan polistirex SUSPENSION ORAL 20121023 ANDA ANDA091135 Target Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 11673-116_4a29dc2b-b68f-471b-a84e-4a5096aa3748 11673-116 HUMAN OTC DRUG up and up gentle laxative Bisacodyl TABLET, COATED ORAL 20150914 OTC MONOGRAPH NOT FINAL part334 Target Corporation BISACODYL 5 mg/1 N 20181231 11673-117_c88f05c0-b62a-4d60-a046-97be6fe085ab 11673-117 HUMAN OTC DRUG up and up lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 Target Corporation LANSOPRAZOLE 15 mg/1 N 20181231 11673-120_7ca3564d-6211-4b37-83c2-3f0c2bb6e1c2 11673-120 HUMAN OTC DRUG WOMENS LAXATIVE Bisacodyl TABLET, COATED ORAL 20100721 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation BISACODYL 5 mg/1 N 20181231 11673-124_f99c792f-2585-45ce-9a2b-08acdd267da3 11673-124 HUMAN OTC DRUG up and up nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20110221 ANDA ANDA090711 Target Corporation NICOTINE 2 mg/1 N 20181231 11673-125_978b54d6-b61e-486e-8c56-8dcf8dbce715 11673-125 HUMAN OTC DRUG up and up 5-symptom digestive relief Bismuth subsalicylate TABLET ORAL 20150907 OTC MONOGRAPH FINAL part335 Target Corporation BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 11673-130_79a0337e-bf4a-4964-a248-13d09466716c 11673-130 HUMAN OTC DRUG Up and Up Childrens acetaminophen Acetaminophen SUSPENSION ORAL 20090708 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 11673-131_975ca696-f70e-a44b-8faf-2892e0fd0b1b 11673-131 HUMAN OTC DRUG Ranitidine 75 Ranitidine Tablets USP, 75mg TABLET ORAL 20131122 ANDA ANDA075294 Target Brands Inc RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 11673-133_c1dd8330-fb6b-4d1f-9484-c199dc69214d 11673-133 HUMAN OTC DRUG up and up acetaminophen infants Acetaminophen SUSPENSION ORAL 20150422 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 11673-141_361ac581-5fcf-43ab-b6a5-15e3bce88169 11673-141 HUMAN OTC DRUG Alcohol Prep Pads benzocaine SWAB TOPICAL 20100219 OTC MONOGRAPH NOT FINAL part348 Target Corporation BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 E 20171231 11673-142_1c65f794-835f-4caa-bcd2-a60de3cac808 11673-142 HUMAN OTC DRUG Up and up vagicaine Benzocaine, Resorcinol CREAM TOPICAL 20090825 OTC MONOGRAPH NOT FINAL part348 Target Corporation BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g N 20181231 11673-153_bcc5e806-c173-4725-b2e6-0c97c7ef83e8 11673-153 HUMAN OTC DRUG Everyday Clean Dandruff pyrithione zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Target Corporation PYRITHIONE ZINC 10 mg/mL N 20181231 11673-154_8229a0f6-6138-4605-8777-2fe37daa286d 11673-154 HUMAN OTC DRUG up and up antifungal tolnaftate SPRAY TOPICAL 20170628 OTC MONOGRAPH FINAL part333C Target Corporation TOLNAFTATE 1 g/100g N 20181231 11673-159_6471c1cc-218b-48a7-a998-dcb9bea97b10 11673-159 HUMAN OTC DRUG Pain Reliever Added Strength Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 20180507 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 11673-160_525c218a-1882-42aa-97ba-2cfa0160fb67 11673-160 HUMAN OTC DRUG up and up juniors acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20151019 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/1 N 20181231 11673-160_72804e03-4043-4188-85ac-9272f13856a3 11673-160 HUMAN OTC DRUG up and up juniors acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20151015 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/1 N 20181231 11673-160_856fd859-1f0c-4ca7-98f8-f151f61bfe5b 11673-160 HUMAN OTC DRUG Senna Laxative plus Stool Softener DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20100317 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 11673-163_54ffbe31-6194-4246-8a63-e51a2b25610b 11673-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 19940406 OTC MONOGRAPH FINAL part355 Target Corporation SODIUM FLUORIDE 1 mg/mL N 20181231 11673-165_96aae740-2b6a-4166-a1ef-badd56b21f3b 11673-165 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Target Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 11673-166_36d41169-095b-42d0-a08f-d9cf62668587 11673-166 HUMAN OTC DRUG Up and Up childrens ibuprofen Ibuprofen SUSPENSION ORAL 20090612 ANDA ANDA074937 Target Corporation IBUPROFEN 100 mg/5mL N 20181231 11673-170_f613da28-9a9c-4beb-9f62-43d5ee6fe22b 11673-170 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20100312 ANDA ANDA076789 Target Corporation NICOTINE 4 mg/1 N 20181231 11673-173_ab133226-a9a8-483a-bd22-31fc1555bf6e 11673-173 HUMAN OTC DRUG up and up lice complete kit 1 2 3 Piperonyl Butoxide, Pyrethrum Extract KIT 20110206 OTC MONOGRAPH FINAL part358G Target Corporation N 20181231 11673-175_dc6338c0-8f7d-41f6-9a67-0f6bbba9c984 11673-175 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141230 NDA NDA021920 TARGET Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 11673-176_a6bd079d-81c9-4f71-87c1-6553f08dc21b 11673-176 HUMAN OTC DRUG Up and Up all day allergy relief d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20090728 ANDA ANDA077170 Target Corporation CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 11673-178_91bdeffa-f120-419a-9bfc-9d6db50afb58 11673-178 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine HCl LIQUID ORAL 20150131 ANDA ANDA090474 TARGET Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL E 20171231 11673-179_0a4dfb35-6c16-415b-abd9-a2476da8d3b2 11673-179 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20171130 OTC MONOGRAPH NOT FINAL part334 Target Corp MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 11673-180_c3184a34-857e-405d-b27c-48a2b6d0f21c 11673-180 HUMAN OTC DRUG Senna Laxative SENNOSIDES TABLET ORAL 20130830 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation SENNOSIDES 8.6 mg/1 N 20181231 11673-183_736c09a6-7b18-4071-8991-a52c1186393f 11673-183 HUMAN OTC DRUG up and up ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20100311 ANDA ANDA077349 Target Corporation IBUPROFEN 200 mg/1 N 20181231 11673-189_ccefe75f-9e22-4916-9f59-1cc6c7ccb271 11673-189 HUMAN OTC DRUG up and up hair regrowth treatment for women Minoxidil SOLUTION TOPICAL 20150831 ANDA ANDA075357 Target Corporation MINOXIDIL 2 g/100mL N 20181231 11673-190_457a6868-cc46-483a-babc-e766ae69290d 11673-190 HUMAN OTC DRUG up and up nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20110312 ANDA ANDA090711 Target Corporation NICOTINE 4 mg/1 N 20181231 11673-194_c1b8799a-c5c8-43fa-9265-8684c5e24316 11673-194 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20000216 NDA NDA020165 Target Corporation NICOTINE 21 mg/24h N 20181231 11673-195_c1b8799a-c5c8-43fa-9265-8684c5e24316 11673-195 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20000216 NDA NDA020165 Target Corporation NICOTINE 14 mg/24h N 20181231 11673-196_c1b8799a-c5c8-43fa-9265-8684c5e24316 11673-196 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20000216 NDA NDA020165 Target Corporation NICOTINE 7 mg/24h N 20181231 11673-197_56366b3c-243e-425b-99f4-07294e9c733d 11673-197 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20100801 ANDA ANDA078682 TARGET Corporation IBUPROFEN 200 mg/1 N 20181231 11673-198_a556a37a-502b-4a46-8afa-5f5afa662f6e 11673-198 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Target Corporation DIMENHYDRINATE 50 mg/1 N 20181231 11673-199_cbde7bce-cb19-486e-a8a2-c7cc43bce2ac 11673-199 HUMAN OTC DRUG up and up miconazole Miconazole nitrate KIT 20100708 ANDA ANDA079114 Target Corporation N 20181231 11673-202_16768538-ae65-415f-9fc6-489bb9fb80ba 11673-202 HUMAN OTC DRUG up and up hydrocortisone Hydrocortisone CREAM TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part348 Target Corporation HYDROCORTISONE 1 g/100g N 20191231 11673-203_eccf77cf-b212-4a94-9c63-43fbaa80ba9e 11673-203 HUMAN OTC DRUG Antiacterial Hand Sanitizer Alcohol GEL TOPICAL 20110907 OTC MONOGRAPH NOT FINAL part333A Target Corp ALCOHOL .65 mL/100L N 20181231 11673-204_07b0b2ac-256c-451d-846c-e63d141c9850 11673-204 HUMAN OTC DRUG up and up sinus pe Phenylephrine Hydrochloride TABLET ORAL 20150312 OTC MONOGRAPH FINAL part341 Target Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 11673-205_444dfd82-7d52-48e0-82d2-0f1f861b35ee 11673-205 HUMAN OTC DRUG Therapeutic T Plus Coal Tar SHAMPOO TOPICAL 20070129 OTC MONOGRAPH FINAL part358H Target Corp COAL TAR 25 mg/mL N 20191231 11673-206_c7eb503f-8cbe-435c-b8a9-03bf73b98ab3 11673-206 HUMAN OTC DRUG up and up nicotine polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20111006 ANDA ANDA078325 Target Corporation NICOTINE 2 mg/1 N 20181231 11673-208_d881cc46-4642-4167-8b1e-dfcb06ce8be4 11673-208 HUMAN OTC DRUG Childrens All Day Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Target Corporation CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 11673-210_23fb5ea1-6d15-4aa4-a985-1e9b42e43689 11673-210 HUMAN OTC DRUG Up and Up Arthritis Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150306 ANDA ANDA075077 Target Corporation ACETAMINOPHEN 650 mg/1 N 20181231 11673-211_e2bf9e57-3fe8-4443-8aaf-391af111483f 11673-211 HUMAN OTC DRUG Allergy Relief Cetirizine HCl CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA022429 TARGET Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 11673-213_34eb710c-ba6b-4bee-a9dd-c055b5b3a0eb 11673-213 HUMAN OTC DRUG Fluoride Mouth Rinse Anticavity Sodium Fluoride MOUTHWASH ORAL 20100817 OTC MONOGRAPH FINAL part355 Target Corp. SODIUM FLUORIDE .2 mg/mL N 20181231 11673-214_05a830d3-a75d-40db-8156-f33ec1c3ce53 11673-214 HUMAN OTC DRUG Smooth and glossy pyrithione zinc SHAMPOO TOPICAL 19991012 OTC MONOGRAPH FINAL part358H Target Corporation PYRITHIONE ZINC 10.4 mg/mL N 20181231 11673-217_bbd37667-9b50-4ca7-84e6-cc65cb1d596e 11673-217 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110914 ANDA ANDA079174 TARGET Corporation IBUPROFEN 200 mg/1 E 20171231 11673-218_4110ed54-131c-44b7-90bc-4c075e8ee176 11673-218 HUMAN OTC DRUG Clear Anti-Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 19960331 OTC MONOGRAPH NOT FINAL part347 Target Cop PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 11673-222_ebd1f81d-8d9e-4e9f-a7ab-b1a8d83b055b 11673-222 HUMAN OTC DRUG Ready-to-Use Enema Sodium Phosphate ENEMA RECTAL 20120823 OTC MONOGRAPH NOT FINAL part334 Target Corporation SODIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC 19; 7 g/118mL; g/118mL E 20171231 11673-224_a21cae61-3861-4123-be10-ccd93a98aea3 11673-224 HUMAN OTC DRUG Up and Up anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20090720 ANDA ANDA075232 Target Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 11673-226_03a482be-5208-4a5e-abd2-6e4f532964aa 11673-226 HUMAN OTC DRUG Diaper Rash Zinc Oxide CREAM TOPICAL 19940808 OTC MONOGRAPH FINAL part347 Target Corporation ZINC OXIDE 130 mg/g N 20181231 11673-229_75b9c108-3726-4a9d-9900-86d6d5ee4635 11673-229 HUMAN OTC DRUG NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING ORAL 20100215 NDA NDA018612 Target Corporation NICOTINE 2 mg/1 N 20181231 11673-230_75b9c108-3726-4a9d-9900-86d6d5ee4635 11673-230 HUMAN OTC DRUG NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING ORAL 20100215 NDA NDA020066 Target Corporation NICOTINE 4 mg/1 N 20181231 11673-236_b67cd68b-e894-47d6-98d3-43572993c369 11673-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 TARGET Corporation DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 E 20171231 11673-238_b4a2a108-3439-4a6d-ad8b-cbd182660c1b 11673-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130715 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation DOCUSATE SODIUM 100 mg/1 E 20171231 11673-245_f48fce97-f3cd-4153-9030-e4f2f156805e 11673-245 HUMAN OTC DRUG Laxative pills Maximum Strength Sennosides TABLET ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation SENNOSIDES 25 mg/1 N 20181231 11673-246_38d52bc1-6fd6-4a21-92a5-1d1d3d19d64c 11673-246 HUMAN OTC DRUG Medicated Dandruff Selenium Sulfide SHAMPOO TOPICAL 19900215 OTC MONOGRAPH FINAL part358H Target Corp SELENIUM SULFIDE 10 mg/mL N 20181231 11673-247_0b45064c-ab69-4273-a634-4859fcefc0a8 11673-247 HUMAN OTC DRUG Headache Relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20141130 OTC MONOGRAPH NOT FINAL part343 TARGET Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 11673-248_90b65589-8b12-4fcc-80cc-d438ebe57d7e 11673-248 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20131130 ANDA ANDA079174 TARGET Corporation IBUPROFEN 200 mg/1 E 20171231 11673-249_07c44dc8-b1bd-491f-9c43-fdf55e6c4cc8 11673-249 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20140328 ANDA ANDA079174 TARGET Corporation IBUPROFEN 200 mg/1 E 20171231 11673-250_ca24a510-e97e-4aed-bb0f-2bcc7545162f 11673-250 HUMAN OTC DRUG up and up cold relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20090731 OTC MONOGRAPH FINAL part341 Target Corporation N 20181231 11673-253_a28e7c0a-c11a-41fc-86c2-051bcf50a321 11673-253 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20141217 OTC MONOGRAPH FINAL part358H Target Corporation PYRITHIONE ZINC 10 mg/mL N 20181231 11673-255_53f82242-8c3c-4e20-95ae-a64a6faa2117 11673-255 HUMAN OTC DRUG up and up dye free infants concentrated ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20090708 ANDA ANDA075217 Target Corporation IBUPROFEN 50 mg/1.25mL N 20181231 11673-259_e3c7d088-1eee-47ec-8118-cf704622f7a5 11673-259 HUMAN OTC DRUG Undecylenic Acid Maximum Strength Antifungal Liquid Solution LIQUID TOPICAL 20140601 OTC MONOGRAPH FINAL part333C Target Corporation UNDECYLENIC ACID 25 mg/30mL N 20181231 11673-260_8eee3b9b-11e8-4b4d-8f5e-24ae11191f9c 11673-260 HUMAN OTC DRUG Undecylenic Acid Maximum Strength Antifungal Pen LIQUID TOPICAL 20140401 OTC MONOGRAPH FINAL part333C Target Corporation UNDECYLENIC ACID 25 mg/1.7mL N 20181231 11673-263_a117bec8-7407-452c-beca-f55fc222ccef 11673-263 HUMAN OTC DRUG PREMIUM HAND SANITIZER NECTARINE MINT ETHYL ALCOHOL GEL TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part333E TARGET ALCOHOL 62 mL/100mL N 20181231 11673-263_ba07932b-800b-44cc-a393-78c17d22343e 11673-263 HUMAN OTC DRUG PREMIUM HAND SANITIZER NECTARINE MINT ETHYL ALCOHOL GEL TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part333E TARGET ALCOHOL 62 mL/100mL N 20181231 11673-264_a9cf7c2f-3811-4304-886a-27fd82df28f0 11673-264 HUMAN OTC DRUG PREMIUM HAND SANITIZER CUCUMBER GREEN TEA ETHYL ALCOHOL GEL TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part333E TARGET ALCOHOL 62 mL/100mL N 20181231 11673-264_ccce270e-928c-4e78-be2e-91d316e6eaf4 11673-264 HUMAN OTC DRUG PREMIUM HAND SANITIZER CUCUMBER GREEN TEA ETHYL ALCOHOL GEL TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part333E TARGET ALCOHOL 62 mL/100mL N 20181231 11673-266_31104956-04d7-41b5-82be-219ded5c02a9 11673-266 HUMAN OTC DRUG up and up infants acetaminophen Acetaminophen SUSPENSION ORAL 20150421 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 11673-268_cc70342c-6fbe-4dfc-9b34-a6102e834c4a 11673-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part356 TARGET Corporation HYDROGEN PEROXIDE 2.65 mL/100mL E 20171231 11673-275_689f7d55-2f7b-4e82-a18b-6cc64cec4272 11673-275 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part333A TARGET Corporation ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 11673-276_e0880b0d-f937-447c-b775-e97d5d8c774b 11673-276 HUMAN OTC DRUG Isopropyl alcohol 70 percent Wintergreen Isopropyl alcohol LIQUID TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part333A TARGET Corporation ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 11673-278_085148a9-0f92-4ea1-82f9-63f280768d08 11673-278 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20150210 OTC MONOGRAPH NOT FINAL part333A Target Corp BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 11673-279_2d3dfcf9-3325-4833-81b5-de671c228904 11673-279 HUMAN OTC DRUG up and up hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140523 OTC MONOGRAPH FINAL part346 Target Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 11673-281_52acb3a5-3cbb-458b-bd8d-a18337b64e09 11673-281 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20020718 OTC MONOGRAPH FINAL part358H Target Corporation PYRITHIONE ZINC 10 mg/mL N 20181231 11673-292_ee60e948-36d6-454d-8d92-bb730c3c8586 11673-292 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride SYRUP ORAL 20160731 OTC MONOGRAPH FINAL part341 TARGET Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 11673-293_227f92e7-301d-4154-b479-2706f2ff41c1 11673-293 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20160318 ANDA ANDA078967 Target Corporation NICOTINE 2 mg/1 N 20181231 11673-297_2e29b258-c7cc-47b5-b6ed-af4145b66316 11673-297 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Target Corporation ALCOHOL 567 mg/mL N 20181231 11673-299_580b39c3-151f-4831-8850-4470775af8fc 11673-299 HUMAN OTC DRUG Antiseptic Cetylpyridinium chloride MOUTHWASH ORAL 20080721 OTC MONOGRAPH NOT FINAL part356 Target Corporation CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 11673-299_cd4e02c6-3fed-4ab5-aee8-1306c4ff5b46 11673-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20080721 OTC MONOGRAPH NOT FINAL part356 Target Corporation CETYLPYRIDINIUM CHLORIDE .07 kg/100L N 20181231 11673-300_c75b50b3-57f6-44eb-8ea2-92330d07f00d 11673-300 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20070308 OTC MONOGRAPH FINAL part347 Target Corp LANOLIN; PETROLATUM 133; 459 mg/g; mg/g N 20181231 11673-301_4b2e30f1-93c8-4613-8c7a-57632703a8dc 11673-301 HUMAN OTC DRUG Up and Up Daytime Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20150226 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 11673-304_d2f62c2f-761d-48b4-b374-52c3c5652ed7 11673-304 HUMAN OTC DRUG Up and up nasal oxymetazoline hydrochloride SPRAY NASAL 20090812 OTC MONOGRAPH FINAL part341 Target Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 11673-306_2f92c1ca-982e-4427-a6ab-532a43fb9db6 11673-306 HUMAN OTC DRUG up and up powderlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Target Corporation POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 11673-309_d59c804f-33ab-4a46-b112-e7752f383f7f 11673-309 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170831 ANDA ANDA206393 Target Corporation NICOTINE 4 mg/1 N 20181231 11673-313_b78cf83a-c4ef-43c4-8fe2-23e46b59eae2 11673-313 HUMAN OTC DRUG up and up antibiotic plus pain relief Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20150409 OTC MONOGRAPH FINAL part333B Target Corporation NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g N 20181231 11673-318_96c82069-1818-493c-986f-59174a83a2ec 11673-318 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19960715 OTC MONOGRAPH NOT FINAL part356 Target Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11673-319_08aa94dd-d703-49a8-8329-8dce00c232c4 11673-319 HUMAN OTC DRUG Up and Up anti itch Hydrocortisone CREAM TOPICAL 20091109 OTC MONOGRAPH NOT FINAL part348 Target Corporation HYDROCORTISONE 1 g/100g N 20181231 11673-325_9c29d93e-6df0-4b2f-a179-deae1f64eaa4 11673-325 HUMAN OTC DRUG Up and Up mucus relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160711 ANDA ANDA091009 Target Corporation GUAIFENESIN 1200 mg/1 N 20181231 11673-329_2ffa6d34-cc66-4b70-b3fc-451321945828 11673-329 HUMAN OTC DRUG Magnesium Citrate Lemon Magnesium citrate LIQUID ORAL 20150131 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation MAGNESIUM CITRATE 1.745 g/29.6mL E 20171231 11673-330_90ffc734-cc35-4d46-9278-6eaf4ccdbc96 11673-330 HUMAN OTC DRUG Healing PETROLATUM JELLY TOPICAL 20120103 OTC MONOGRAPH FINAL part346 TARGET CORPORATION PETROLATUM 41 g/100g N 20181231 11673-330_ab9cb71d-5692-477f-b1b5-f0e7fa064c84 11673-330 HUMAN OTC DRUG Healing PETROLATUM JELLY TOPICAL 20120103 OTC MONOGRAPH FINAL part346 TARGET CORPORATION PETROLATUM 41 g/100g N 20181231 11673-332_586953e8-e15b-415d-b49e-68d71e3473c7 11673-332 HUMAN OTC DRUG UP and UP CREAMY DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20120423 OTC MONOGRAPH FINAL part346 TARGET CORPORATION ZINC OXIDE 13 g/100g N 20181231 11673-334_8f5f8e5f-06da-4888-9bcd-51b216608bf4 11673-334 HUMAN OTC DRUG UP and UP DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20120420 OTC MONOGRAPH FINAL part346 TARGET CORPORATION ZINC OXIDE 40 g/100g N 20181231 11673-336_cf18584d-1e66-439a-9436-1eb4b1086c3d 11673-336 HUMAN OTC DRUG Fast Mucus Relief Cold Flu and Sore Throat Maximum Strength Multi-Symptom Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 TARGET Corporation DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 650; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL E 20171231 11673-337_c43ca2e8-218a-4512-a795-0c38337ac52c 11673-337 HUMAN OTC DRUG Mucus Relief Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI LIQUID ORAL 20160731 OTC MONOGRAPH FINAL part341 TARGET Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL E 20171231 11673-340_89911c15-f5cf-4013-b4da-0fbf0b7383dd 11673-340 HUMAN OTC DRUG UP AND UP DIAPER RASH LANOLIN, PETROLATUM OINTMENT TOPICAL 20120430 OTC MONOGRAPH FINAL part347 TARGET CORPORATION LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g N 20181231 11673-344_efd50c5a-1edd-4d29-ab08-dcc3bbceee45 11673-344 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex LOZENGE ORAL 20090616 ANDA ANDA077007 Target Corporation NICOTINE 2 mg/1 N 20181231 11673-350_8ffe3f78-5eba-44c9-be6e-c57564317d06 11673-350 HUMAN OTC DRUG UP and UP PETROLATUM JELLY TOPICAL 20120103 OTC MONOGRAPH FINAL part346 TARGET CORPORATION PETROLATUM 99.9 g/100g N 20181231 11673-351_351b3079-392d-47ef-b8da-6cab3df04b20 11673-351 HUMAN OTC DRUG UP AND UP PETROLEUM WHITE PETROLATUM JELLY TOPICAL 20120413 OTC MONOGRAPH FINAL part346 TARGET CORPORATION PETROLATUM 99.6 g/100g N 20181231 11673-352_725b8ef5-a6a4-49eb-8d32-9f148e083c9d 11673-352 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20110210 ANDA ANDA078547 Target Corporation NICOTINE 2 mg/1 N 20181231 11673-357_03d60992-6ffe-4d90-8202-28b15ee25dd8 11673-357 HUMAN OTC DRUG up and up antacid anti gas regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20090616 OTC MONOGRAPH FINAL part331 Target Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 11673-358_a64b9929-7939-4a47-8d57-9519a8f424fb 11673-358 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part333A Target Corporation BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 11673-365_39f284c8-f56a-41dc-8501-ac1d6dbc4bf5 11673-365 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20130809 ANDA ANDA091349 Target Corporation NICOTINE 2 mg/1 N 20181231 11673-367_cf5bff48-a3f2-4fce-90ac-e8193f303da1 11673-367 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 11673-368_9a24e869-8d3c-4e08-b231-cd2f2c900c65 11673-368 HUMAN OTC DRUG up and up naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20090624 ANDA ANDA074661 Target Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 11673-370_893f1055-5238-4159-92c9-80dd28543ed2 11673-370 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20121213 OTC MONOGRAPH NOT FINAL part333A Target Corp ALCOHOL 70 mL/100mL N 20181231 11673-371_e98ab33c-08c1-4d55-a0fe-edfc6ecd6d4f 11673-371 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, COATED ORAL 20110405 OTC MONOGRAPH FINAL part343 TARGET Corporation ASPIRIN 325 mg/1 N 20181231 11673-373_79c0df8d-bfab-44fc-84c6-b66d0c594994 11673-373 HUMAN OTC DRUG Pain Relief PM Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 20181104 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 E 20171231 11673-374_2f1b08f1-1eb5-4e03-b133-a31fb404b471 11673-374 HUMAN OTC DRUG Up and Up Migraine Relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20090612 ANDA ANDA075794 Target Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 11673-375_a6784459-fb0c-4488-93e9-df91104cf5cd 11673-375 HUMAN OTC DRUG Sleep Aid NightTime Diphenhydramine HCl LIQUID ORAL 20160731 OTC MONOGRAPH FINAL part338 TARGET Corporation DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL E 20171231 11673-376_a63dc5c3-d1f0-4652-981f-8ae11b1d0278 11673-376 HUMAN OTC DRUG Sore throat cherry Phenol SPRAY ORAL 20160630 OTC MONOGRAPH NOT FINAL part356 TARGET Corporation PHENOL 1.4 g/100mL E 20171231 11673-383_32c2012e-6950-432d-b329-de438fb525b5 11673-383 HUMAN OTC DRUG Foaming Hand Wash Antibacterial Triclosan LIQUID TOPICAL 19930319 OTC MONOGRAPH NOT FINAL part333A Target Corporation TRICLOSAN 6 mg/mL N 20181231 11673-388_d288079c-2c28-47a1-a05f-e10d79d532ee 11673-388 HUMAN OTC DRUG Up and Up allergy relief nasal Fluticasone Propionate SPRAY, METERED NASAL 20161217 ANDA ANDA207957 Target Corporation FLUTICASONE PROPIONATE 50 ug/1 N 20181231 11673-390_c2fbb3ea-a383-4467-af0a-5bd8ee9b312d 11673-390 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20020429 20181104 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 E 20171231 11673-394_92ede62f-582d-4d85-8999-b0ab74932af1 11673-394 HUMAN OTC DRUG phenylephrine hydrochloride phenylephrine hydrochloride SUPPOSITORY RECTAL 20090901 OTC MONOGRAPH FINAL part346 Target Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2077; 6; 73 mg/1; mg/1; mg/1 E 20171231 11673-395_95b7740d-99bb-4dda-910a-0a1e95d62e17 11673-395 HUMAN OTC DRUG COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20110701 OTC MONOGRAPH FINAL part346 Target Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 850; 2.5 mg/g; mg/g E 20171231 11673-397_86d2fc65-c13e-6d7f-3e7e-dd15a610b8a7 11673-397 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium 20.6mg Capsules CAPSULE, DELAYED RELEASE ORAL 20160328 ANDA ANDA078878 Target Corporation OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 11673-400_a640ebe0-9326-45a4-a385-8c41190e8e00 11673-400 HUMAN OTC DRUG Sleep Aid NightTime Diphenhydramine HCL TABLET ORAL 20160731 OTC MONOGRAPH FINAL part338 TARGET Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 11673-401_c0a03ab1-3a10-4e10-85af-c3a8b28bca6e 11673-401 HUMAN OTC DRUG athletes foot terbinafin hydrochloride CREAM TOPICAL 20090831 NDA NDA020980 Target Corporation TERBINAFINE HYDROCHLORIDE 10 mg/g E 20171231 11673-403_250808d7-30aa-40ad-acab-bfde29f13795 11673-403 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 20181104 OTC MONOGRAPH FINAL part336 Target Corporation MECLIZINE HYDROCHLORIDE 25 mg/1 E 20171231 11673-404_59cad05f-4b0b-7aae-e053-2991aa0a0eb9 11673-404 HUMAN OTC DRUG up and up medicated wipes manixim strength gentle hemorrhoidal care SWAB TOPICAL 20150101 OTC MONOGRAPH FINAL part346 Target Corporation WITCH HAZEL .5 g/g N 20181231 11673-405_a6115f22-00c6-4288-938b-c57159721dd4 11673-405 HUMAN OTC DRUG up and up antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140608 OTC MONOGRAPH FINAL part333B Target Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 11673-406_29284788-5676-6f0d-e054-00144ff8d46c 11673-406 HUMAN OTC DRUG Up and up Alcohol prep pad antiseptic SWAB TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part333A Target Corporation ALCOHOL .7 mL/mL N 20181231 11673-407_58d0ac6b-2075-4034-82a5-c0c25578e4af 11673-407 HUMAN OTC DRUG Up and Up Cold Sore Treatment Camphor CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Target CAMPHOR (SYNTHETIC); BENZALKONIUM CHLORIDE 30; 1.3 mg/g; mg/g N 20181231 11673-408_247dec93-8e51-45a5-93bb-0d93f13bbf77 11673-408 HUMAN OTC DRUG Saline Wash Sodium Bicarbonate, Sodium Chloride POWDER, FOR SOLUTION ORAL 20130401 UNAPPROVED DRUG OTHER Target Corporation SODIUM CHLORIDE; SODIUM BICARBONATE 700; 2300 mg/1; mg/1 N 20181231 11673-409_59c9f77d-44e6-bcff-e053-2991aa0a4c31 11673-409 HUMAN OTC DRUG Up and up Oil-free Cleansing wipe pink grapefruit salicylic acid CLOTH TOPICAL 20170101 OTC MONOGRAPH FINAL part333D Target Corporation SALICYLIC ACID 20 mg/mL N 20181231 11673-410_cc2cec32-2366-4e5e-a441-5fd0093d8097 11673-410 HUMAN OTC DRUG Mucus Relief Severe Cold Daytime Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20160831 OTC MONOGRAPH FINAL part341 TARGET Corporation DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 650; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL E 20171231 11673-411_580b1def-25cc-4bdd-b80e-e2035b004808 11673-411 HUMAN OTC DRUG up and up nicotine Nicotine polacrilex GUM, CHEWING ORAL 20170830 ANDA ANDA206394 Target Corporation NICOTINE 2 mg/1 N 20181231 11673-416_afc88619-384a-4367-8759-e53d9cafd8c8 11673-416 HUMAN OTC DRUG Up and Up aspirin Aspirin TABLET ORAL 20090610 OTC MONOGRAPH NOT FINAL part343 Target Corporation ASPIRIN 325 mg/1 N 20181231 11673-417_986cc981-9cce-4e73-b422-d5c4caa93004 11673-417 HUMAN OTC DRUG Up and Up Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130830 ANDA ANDA076518 Target Corporation NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 11673-420_14d88c82-585c-4f95-bae4-c0ab732f1e1d 11673-420 HUMAN OTC DRUG Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI, Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI KIT 20170228 OTC MONOGRAPH FINAL part341 TARGET Corporation N 20181231 11673-422_c59b23e1-34f5-46ef-80b0-e9f47b97e941 11673-422 HUMAN OTC DRUG up and up nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20111006 ANDA ANDA078326 Target Corporation NICOTINE 4 mg/1 N 20181231 11673-423_586f87fc-2225-43d7-b980-335d10e0069b 11673-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, COATED ORAL 20011008 ANDA ANDA074567 Target Corporation IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 11673-426_68961590-7193-49d0-9084-a3482bd2123a 11673-426 HUMAN OTC DRUG Up and up tioconazole 1 Tioconazole OINTMENT VAGINAL 20090708 ANDA ANDA075915 Target Corporation TIOCONAZOLE 6.5 g/100g N 20181231 11673-428_cb3d0ca1-7048-443b-95f2-fea05984b792 11673-428 HUMAN OTC DRUG tension headache relief Acetaminophen, Caffeine TABLET, FILM COATED ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 11673-430_ae0f20a0-2aa7-480a-a20a-cfaf271a65aa 11673-430 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20100831 NDA NDA020065 Target Corporation NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL N 20181231 11673-434_6d6c0b32-9b5a-4499-a7ff-d1b46d2b3015 11673-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 Target Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11673-435_9c1e85c3-3243-4bbe-9e11-70d4f18978eb 11673-435 HUMAN OTC DRUG Sodium fluoride Sodium fluoride SOLUTION ORAL 20150628 OTC MONOGRAPH FINAL part355 Target Corp. SODIUM FLUORIDE .2 mg/mL N 20181231 11673-437_be83d98e-57b4-46a6-912f-bd7cbb17caac 11673-437 HUMAN OTC DRUG up and up acetaminophen pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20090626 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 11673-439_32c0bbd8-61d4-4774-a9d8-9c3c9a7ba338 11673-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20121213 OTC MONOGRAPH NOT FINAL part333A Target Corp ALCOHOL 700 mg/mL N 20181231 11673-442_61a34d76-13f4-4399-9ac6-e3f4e837d2e3 11673-442 HUMAN OTC DRUG Up and Up Nicotine Polacrilex Nicotine polacrilex GUM, CHEWING ORAL 20130809 ANDA ANDA091354 Target Corporation NICOTINE 4 mg/1 N 20181231 11673-443_9a97c862-c50d-4ebb-ab93-00f7e1f902ff 11673-443 HUMAN OTC DRUG Salicylic acid Liquid Wart Remover LIQUID TOPICAL 20081231 OTC MONOGRAPH FINAL part358B Target Corporation SALICYLIC ACID 2.1 g/14.7mL N 20181231 11673-444_ac8c6f16-efa6-4a30-856c-67907f5003a9 11673-444 HUMAN OTC DRUG up and up acetaminophen Acetaminophen TABLET ORAL 20140820 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 325 mg/1 N 20181231 11673-447_388fe582-2bac-46dc-9192-ceab98299703 11673-447 HUMAN OTC DRUG childrens acetaminophen melts Acetaminophen TABLET, ORALLY DISINTEGRATING ORAL 20050203 20181104 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 80 mg/1 E 20171231 11673-449_753cad5c-1e44-4bbd-b2ea-c7d2b95fa85e 11673-449 HUMAN OTC DRUG Junior Strength Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050128 20190804 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/1 E 20171231 11673-450_31f09e3e-ccd8-404d-a691-f5003075a154 11673-450 HUMAN OTC DRUG junior strength acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050225 20180331 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/1 E 20171231 11673-451_f97034b0-a82a-4493-adab-b0765c50e202 11673-451 HUMAN OTC DRUG lubricant and redness reliever Naphazoline Hydrochloride and Polyethylene glycol 300 SOLUTION/ DROPS OPHTHALMIC 20100913 OTC MONOGRAPH FINAL part349 Target Corporation NAPHAZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 300 .1; 2 mg/mL; mg/mL N 20181231 11673-452_5928d5ba-6eee-4ae6-b85b-d525ff2e402f 11673-452 HUMAN OTC DRUG Childrens Acetaminophen Melts Acetaminophen TABLET, CHEWABLE ORAL 20041206 20180416 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 80 mg/1 E 20171231 11673-456_18c4f1c6-2b57-443f-983d-305f840a486d 11673-456 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20090701 ANDA ANDA076777 Target Corporation NICOTINE 2 mg/1 N 20181231 11673-460_ae0176bb-8cd3-46e6-ac24-23c098283dd4 11673-460 HUMAN OTC DRUG Nighttime Cold and Flu Maximum Strength Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI LIQUID ORAL 20160831 OTC MONOGRAPH FINAL part341 TARGET Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL E 20171231 11673-461_832824d2-92c0-4fb0-9b52-2c68cfc29bad 11673-461 HUMAN OTC DRUG Up and Up Ibuprofen Junior Ibuprofen TABLET, CHEWABLE ORAL 20130304 ANDA ANDA076359 Target Corporation IBUPROFEN 100 mg/1 N 20181231 11673-462_e5d553df-3a06-4b9d-ba49-c5222d55f69f 11673-462 HUMAN OTC DRUG up and up allergy relief diphenhydramine hydrochloride CAPSULE ORAL 20090610 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 11673-463_9775d7a3-f121-4dd3-b7fb-8beaa78bcc23 11673-463 HUMAN OTC DRUG DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum Strength Daytime Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI, NightTime Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI KIT 20180111 OTC MONOGRAPH FINAL part341 TARGET Corporation N 20191231 11673-466_352dc2d0-ea8b-4682-877a-1440003793f0 11673-466 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20160217 OTC MONOGRAPH NOT FINAL part333A Target Corp. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11673-467_a7583fd4-3166-439b-aa39-917cd64f73ff 11673-467 HUMAN OTC DRUG Up and Up Aspirin Aspirin TABLET, CHEWABLE ORAL 20090624 OTC MONOGRAPH NOT FINAL part343 Target Corporation ASPIRIN 81 mg/1 N 20181231 11673-470_30df8543-2c0e-4127-933f-f934971eb124 11673-470 HUMAN OTC DRUG Daytime Multi-Symptom Cold Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 20181104 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 11673-475_253a97bc-9c03-4b7b-94d5-8362367e1c06 11673-475 HUMAN OTC DRUG Up and Up Childrens Allergy Relief Cetirizine HCl SOLUTION ORAL 20151015 ANDA ANDA204226 Target Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20191231 11673-479_34b6d61f-17c4-41da-b4a0-6024a80caff7 11673-479 HUMAN OTC DRUG ANTACID extra strength calcium carbonate TABLET, CHEWABLE ORAL 20100215 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 11673-480_34b6d61f-17c4-41da-b4a0-6024a80caff7 11673-480 HUMAN OTC DRUG ANTACID extra strength calcium carbonate TABLET, CHEWABLE ORAL 20100215 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 11673-481_de29d0ac-6dd3-4893-b43e-acca42ec9f8e 11673-481 HUMAN OTC DRUG ANTACID calcium carbonate TABLET ORAL 20100215 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 1000 mg/1 N 20181231 11673-482_81d12995-60b4-4e59-8230-5224087032b7 11673-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20120309 OTC MONOGRAPH FINAL part355 Target Corporation SODIUM FLUORIDE .1 mg/mL N 20181231 11673-484_5060ccde-cf1e-404c-873f-b71289863eb6 11673-484 HUMAN OTC DRUG up and up acetaminophen extra strength Acetaminophen TABLET ORAL 20091202 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 500 mg/1 N 20181231 11673-485_a533014a-8f50-4e5d-b89b-e5f5e50fbe48 11673-485 HUMAN OTC DRUG stool softening senna laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20151130 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 11673-488_261c8855-7249-49cd-9d8c-ed80146820fb 11673-488 HUMAN OTC DRUG maximum strength antifungal nail liquid UNDECYLENIC ACID LIQUID TOPICAL 20171116 OTC MONOGRAPH FINAL part333C Target Corporation UNDECYLENIC ACID 7.5 g/30mL N 20181231 11673-492_19d2dad1-0160-4d5c-baeb-44a1bff5fe21 11673-492 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation SENNOSIDES 25 mg/1 N 20181231 11673-497_13c184ab-ef49-42b6-ba22-614a26abb20b 11673-497 HUMAN OTC DRUG Up and Up Jock Itch Relief Miconazole Nitrate SPRAY TOPICAL 20130925 OTC MONOGRAPH FINAL part333C Target Corporation MICONAZOLE NITRATE 2 g/100g N 20181231 11673-500_7cecab1c-e2c3-483c-9a6f-8bc57a23702a 11673-500 HUMAN OTC DRUG up and up nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20150310 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 11673-502_8ca74ffb-aa41-48da-b3af-3a37366d5597 11673-502 HUMAN OTC DRUG Up and Up Allergy Relief Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20141217 ANDA ANDA078336 Target Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 11673-503_23dae1d6-8748-42c8-b277-acf81e92350b 11673-503 HUMAN OTC DRUG Severe Cold Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Guaifenesin TABLET, FILM COATED ORAL 20060622 20181104 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 11673-504_9b77d64e-6226-4251-baa4-21f0eade6c36 11673-504 HUMAN OTC DRUG Up and Up Jock Itch Relief Clotrimazole CREAM TOPICAL 20130917 OTC MONOGRAPH FINAL part333C Target Corporation CLOTRIMAZOLE 1 g/100g N 20181231 11673-510_f1ef740b-2131-456b-abdc-783e8d90d909 11673-510 HUMAN OTC DRUG Maximum Strength Medicated Foot Powder Medicated Foot Powder POWDER TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part348 Target Corporation MENTHOL .1 g/g N 20181231 11673-511_a7fca7b1-33ba-4508-bb17-702979a29d88 11673-511 HUMAN OTC DRUG Menthol Maximum Strength Medicated Foot Powder Talc Free POWDER TOPICAL 20171127 OTC MONOGRAPH NOT FINAL part348 Target Corporation MENTHOL 2.8 g/283g N 20181231 11673-513_710cd931-0ca1-45b3-a430-14237c2365f4 11673-513 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Target Corporation LORATADINE 10 mg/1 N 20181231 11673-517_eaf9a012-378f-440a-9b53-0bb22e83428f 11673-517 HUMAN OTC DRUG up and up ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA077349 Target Corporation IBUPROFEN 200 mg/1 N 20181231 11673-519_9dcdfa2a-6ee3-4e1d-b989-128740212c2a 11673-519 HUMAN OTC DRUG acetaminophen Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 500 mg/1 N 20181231 11673-520_c3e0c0b6-fb33-4a99-addd-680bd252405c 11673-520 HUMAN OTC DRUG Loperamide HCl LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20111001 NDA NDA021855 TARGET Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 11673-521_82fd7b52-3daa-4353-b330-c58794c4af57 11673-521 HUMAN OTC DRUG up and up junior strength ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20100622 ANDA ANDA076359 Target Corporation IBUPROFEN 100 mg/1 N 20181231 11673-525_d0826035-ee62-4635-8ce6-ac811173b705 11673-525 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20160630 OTC MONOGRAPH NOT FINAL part343 TARGET Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 11673-526_03734d48-d530-47ce-b678-d2ce11b88560 11673-526 HUMAN OTC DRUG Suphedrine PE Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED ORAL 20050621 20181104 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 E 20171231 11673-527_710cd931-0ca1-45b3-a430-14237c2365f4 11673-527 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Target Corporation LORATADINE 10 mg/1 E 20171231 11673-532_4fac4316-f161-454d-ba41-1e8d4fa5a721 11673-532 HUMAN OTC DRUG Up and Up nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20090709 ANDA ANDA076779 Target Corporation NICOTINE 4 mg/1 N 20181231 11673-542_62eec235-431f-4429-b173-d4a9b45a4e36 11673-542 HUMAN OTC DRUG daytime severe cold and cough and nighttime severe cold and cough Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl KIT 20170731 OTC MONOGRAPH FINAL part341 Target Corporation N 20191231 11673-544_f53ee1bf-1ba1-4962-8196-5584ae36e746 11673-544 HUMAN OTC DRUG up and up temporary minor arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090623 ANDA ANDA075077 Target Corporation ACETAMINOPHEN 650 mg/1 N 20181231 11673-545_4d33b0aa-e11a-4a93-88db-b525e0bc8025 11673-545 HUMAN OTC DRUG Instant hand Sanitizer ALCOHOL GEL TOPICAL 20090109 OTC MONOGRAPH NOT FINAL part333A Target Corp. ALCOHOL .62 kg/100L N 20181231 11673-550_774ba2c8-3a9f-405c-b92b-b7aacccf11c5 11673-550 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130830 OTC MONOGRAPH FINAL part347 Target Corporation DIMETHICONE 125 mg/1 E 20171231 11673-551_73149505-a2aa-4f13-bdce-65a4299b5303 11673-551 HUMAN OTC DRUG Medicated menthol, zinc oxide POWDER TOPICAL 20030730 OTC MONOGRAPH NOT FINAL part348 Target Corporation MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g N 20181231 11673-555_b3ca5e87-2542-4c54-8090-38bf191522fa 11673-555 HUMAN OTC DRUG up and up allergy plus congestion relief d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20150312 ANDA ANDA077170 Target Corporation CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 11673-556_9a6b4226-b417-443a-9cb1-e1ddbc3f9da1 11673-556 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 11673-560_a48fd5ee-36f3-4b1e-a765-7d2a63404d00 11673-560 HUMAN OTC DRUG Multi-Symptom Daytime Cold Acetaminophen, Phenylephrine HCl and Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20080329 20181104 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 11673-562_bc1dbe4c-8a41-4547-9915-21238a5914fe 11673-562 HUMAN OTC DRUG Up and Up multi action antibiotic Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20170511 OTC MONOGRAPH FINAL part333B Target Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 11673-563_f8c9a088-57da-42e0-b272-bb18e675a27b 11673-563 HUMAN OTC DRUG coated aspirin low-dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 Target Corporation ASPIRIN 81 mg/1 N 20191231 11673-564_45e85f23-76d8-4daa-a4ee-ce3fca16f27b 11673-564 HUMAN OTC DRUG up and up pain relieving cleansing BENZALKONIUM CHLORIDE, LIDOCAINE SPRAY TOPICAL 20171122 OTC MONOGRAPH NOT FINAL part333A Target Corporation BENZALKONIUM CHLORIDE; LIDOCAINE .192; 3.695 g/147.8mL; g/147.8mL N 20181231 11673-566_2c5fbb9e-8b6d-43de-9312-b6eb34f79504 11673-566 HUMAN OTC DRUG up and up odor-free pain relieving cream TROLAMINE SALICYLATE CREAM TOPICAL 20171129 OTC MONOGRAPH NOT FINAL part348 Target Corporation TROLAMINE SALICYLATE 8.5 g/85g N 20181231 11673-571_2b5287f2-2543-4a5a-968d-3d7cdbbee209 11673-571 HUMAN OTC DRUG up and up allergy relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110413 ANDA ANDA076447 Target Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 11673-572_dc36f647-2d3c-442b-b16d-7c0ac65414c6 11673-572 HUMAN OTC DRUG glycerin, phenylephrine hydrochloride, pramoxine, white petrolatum glycerin, phenylephrine hydrochloride, pramoxine, white petrolatum CREAM RECTAL; TOPICAL 20090401 OTC MONOGRAPH FINAL part346 Target Corporation GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM .144; .0025; .01; .15 mg/g; mg/g; mg/g; mg/g E 20171231 11673-575_c8c23d33-f56c-4cae-b373-cbae4459c0f8 11673-575 HUMAN OTC DRUG Nightime Relief Lubricant Eye Mineral Oil, and White Petrolatum OINTMENT OPHTHALMIC 20150305 OTC MONOGRAPH FINAL part349 Target Corporation MINERAL OIL; PETROLATUM 425; 533 mg/g; mg/g N 20181231 11673-576_78468987-8704-4cf7-aacc-9be173e99241 11673-576 HUMAN OTC DRUG Extreme Relief Lubricant Polyethylene Glycol 400, and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20150304 OTC MONOGRAPH FINAL part349 Target Corporation POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 11673-578_9717aedf-110f-44a0-b481-2d107dda53ad 11673-578 HUMAN OTC DRUG Red Eye Relief Glycerin, and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20150304 OTC MONOGRAPH FINAL part349 Target Corporation GLYCERIN; NAPHAZOLINE HYDROCHLORIDE 500; 30 mg/100mL; mg/100mL N 20181231 11673-583_24a46ec5-3564-4e45-9bb2-03dd673d72a0 11673-583 HUMAN OTC DRUG allergy and cold relief Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl CAPSULE ORAL 20090710 20180610 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 E 20171231 11673-584_77736e32-914a-4eaf-9b25-e40b7d5bbc36 11673-584 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20151031 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 11673-585_a0531919-ea5f-446e-ac5a-9d5ab2230d8d 11673-585 HUMAN OTC DRUG Cinnamon Sugar Ethyl Alcohol GEL TOPICAL 20121213 OTC MONOGRAPH NOT FINAL part333A Target Corp., ALCOHOL 558 mg/mL N 20181231 11673-586_63102f82-0ff6-4223-e053-2991aa0a488a 11673-586 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray with Baking Soda AEROSOL, POWDER TOPICAL 20081231 OTC MONOGRAPH FINAL part333C Target Corporation TOLNAFTATE 1.1 g/113.3g N 20191231 11673-596_5d942f33-8dcf-5537-e053-2991aa0ad7c7 11673-596 HUMAN OTC DRUG UpandUP Salicylic Acid TAPE TOPICAL 20171120 OTC MONOGRAPH FINAL part358H Target Corporation SALICYLIC ACID 4 mg/1 N 20181231 11673-597_a2c0b14c-b6ab-4c41-a7c1-aaaaebc98a87 11673-597 HUMAN OTC DRUG Up and Up severe cold and flu acetaminophen, dextromethorphan HBr, doxylamine succinate, guaifenesin, phenylephrine HCl KIT 20160719 OTC MONOGRAPH FINAL part341 Target Corporation N 20181231 11673-599_ed128653-9e87-42dd-b8cd-25aa79c73a5c 11673-599 HUMAN OTC DRUG Childrens Allergy Melts Diphenhydramine HCl TABLET, CHEWABLE ORAL 20110425 20190804 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 E 20171231 11673-600_112e2e0e-b96b-4753-8df1-800b0e3ca23f 11673-600 HUMAN OTC DRUG Alcohol Prep Pad isopropyl alcohol SWAB TOPICAL 20080701 OTC MONOGRAPH NOT FINAL part333E Target Corporation ISOPROPYL ALCOHOL .7 mL/1 E 20171231 11673-601_ed97b907-6742-4bd0-b685-a06350378f21 11673-601 HUMAN OTC DRUG Up and Up Nighttime Daytime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20150507 OTC MONOGRAPH FINAL part341 Target Corporation N 20181231 11673-602_20ca52e2-7fdd-422c-a578-79fc2b298acf 11673-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 19961212 OTC MONOGRAPH NOT FINAL part334 Target Corporation MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 11673-603_465c924f-f2e1-4046-82c2-4b9ec92380f3 11673-603 HUMAN OTC DRUG Up and Up severe cold and flu daytime acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20150803 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 11673-604_77634dae-8c20-4733-b261-0be703bc55fb 11673-604 HUMAN OTC DRUG up and up ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090528 ANDA ANDA072096 Target Corporation IBUPROFEN 200 mg/1 N 20181231 11673-610_0a015c48-680c-4de1-91e7-1c1145239d8e 11673-610 HUMAN OTC DRUG up and up extra strength gas relief chewables Extra Strength Simethicone TABLET, CHEWABLE ORAL 20150916 OTC MONOGRAPH FINAL part332 Target Corporation DIMETHICONE 125 mg/1 N 20181231 11673-611_d2f5598e-05cf-43ea-ae4b-12651255f7f0 11673-611 HUMAN OTC DRUG mucus relief DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Target Corporation GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 11673-612_20f47d81-85ef-4f39-b432-586dfda0ae74 11673-612 HUMAN OTC DRUG up and up allergy relief Loratadine TABLET ORAL 20120326 ANDA ANDA076301 Target Corporation LORATADINE 10 mg/1 N 20181231 11673-615_10e50d70-213b-4507-800f-fe308d0f7335 11673-615 HUMAN OTC DRUG up and up extra strength smooth dissolving antacid Assorted Fruit Antacid Tablets TABLET, CHEWABLE ORAL 20151109 OTC MONOGRAPH FINAL part331 Target corporation CALCIUM CARBONATE 750 mg/1 N 20181231 11673-615_ac9b73bd-174b-4a41-a3f1-89273d611b5c 11673-615 HUMAN OTC DRUG Severe Sinus Congestion Relief Acetaminophen, Guaifenesin, Phenylephrine TABLET ORAL 20130407 20190708 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 11673-616_25af543f-c8dd-4e07-b677-517848e2814a 11673-616 HUMAN OTC DRUG up and up cold and flu relief multi symptom day and night combo pack Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20121011 OTC MONOGRAPH FINAL part341 Target Corporation N 20181231 11673-618_a6b2603f-4cca-4fb8-9a16-6e4a6e2eec81 11673-618 HUMAN OTC DRUG Up and Up acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170302 ANDA ANDA075077 Target Corporation ACETAMINOPHEN 650 mg/1 N 20181231 11673-619_75b35af5-a050-4216-bfb4-dddff064021b 11673-619 HUMAN OTC DRUG daytime sinus nighttime sinus maximum strength acetaminophen, diphenhydramine, guaifenesin, phenylephrine HCl KIT 20130630 OTC MONOGRAPH FINAL part341 Target Corporation N 20181231 11673-620_2c15788d-e5b4-43f0-85b7-228bf8c60dc2 11673-620 HUMAN OTC DRUG up and up fiber therapy Calcium polycarbophil TABLET ORAL 20151014 OTC MONOGRAPH NOT FINAL part334 Target Corporation. CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 11673-622_70d7fc41-2557-4b07-aaf2-fc4ea0119c7e 11673-622 HUMAN OTC DRUG Up and Up itch relief Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part348 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 11673-624_f2c0f9e5-61bd-4fb0-a29e-d358609c9270 11673-624 HUMAN OTC DRUG up and up extra strength smooth dissolving antacid Assorted Fruit Antacid Tablets TABLET, CHEWABLE ORAL 20170710 OTC MONOGRAPH FINAL part331 Target corporation CALCIUM CARBONATE 750 mg/1 N 20191231 11673-625_9d3d7a6c-5e57-4ad0-9179-0b991b09fcb4 11673-625 HUMAN OTC DRUG up and up extra strength smooth dissolving antacid Assorted berry Antacid Tablets TABLET, CHEWABLE ORAL 20151026 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 N 20191231 11673-625_e78afe7b-a835-4fdb-9ef8-0499d1a83e6e 11673-625 HUMAN OTC DRUG up and up extra strength smooth dissolving antacid Assorted berry Antacid Tablets TABLET, CHEWABLE ORAL 20170612 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 N 20191231 11673-626_53d83dea-ee02-493d-9a44-2fd39e29a682 11673-626 HUMAN OTC DRUG up and up nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20150211 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 11673-628_dd4ff466-d704-4b25-9550-6464c898650c 11673-628 HUMAN OTC DRUG Sinus Pressure and Pain Relief extra strength acetaminophen, guaifenesin, phenylephrine HCl TABLET ORAL 20130503 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 11673-629_489f93d0-66d2-4aba-8a17-a99c4cdc2865 11673-629 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part333A Target Corporation BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/10mL; mg/10mL N 20181231 11673-631_3a4173aa-b57a-49a2-a5e9-77ce3109cc6e 11673-631 HUMAN OTC DRUG Salicylic acid Medicated Callus Removers Extra Thick PATCH TOPICAL 20171201 OTC MONOGRAPH FINAL part358F Target Corporation SALICYLIC ACID 40 mg/41 N 20181231 11673-632_f2c84ed7-5787-44df-a0fa-ec6ff5769ced 11673-632 HUMAN OTC DRUG up and up hair regrowth treatment for men Minoxidil SOLUTION TOPICAL 20150729 ANDA ANDA075598 Target Corporation MINOXIDIL 5 g/100mL N 20181231 11673-633_042a6cdd-fa57-4b15-b052-0bdff8134c61 11673-633 HUMAN OTC DRUG antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part333A Target Corp BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 11673-634_5cbeacb6-e128-45e7-bb60-12bec70ce3b4 11673-634 HUMAN OTC DRUG Undecylenic Acid Antifungal Pen LIQUID TOPICAL 20180201 OTC MONOGRAPH FINAL part333C Target Corporation UNDECYLENIC ACID 25 mg/3mL N 20181231 11673-635_4c358ce2-edc4-4b41-b974-74eb6b4cdbaa 11673-635 HUMAN OTC DRUG Calamine Plus Pramoxine HCl Calamine Plus Spray AEROSOL, SPRAY TOPICAL 20180201 OTC MONOGRAPH NOT FINAL part348 Target Corporation FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE .345; 24.16; 2.72 mg/116g; mg/116g; mg/116g N 20181231 11673-637_2e8cca1f-8eee-4cc2-8d4c-3944135f5ac6 11673-637 HUMAN OTC DRUG up and up antacid anti gas aluminum hydroxide, magnesium hydroxide, simethicone SUSPENSION ORAL 20170831 OTC MONOGRAPH FINAL part331 Target Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 11673-640_e3927bdf-f904-4cdf-93ec-d6beb4360372 11673-640 HUMAN OTC DRUG severe cold and flu daytime acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140227 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 11673-641_837481f5-7454-4d63-9750-d978b021b555 11673-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part333A Target Corporation BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 11673-645_31a2183c-1361-4b89-98aa-af865a98ced6 11673-645 HUMAN OTC DRUG PE multi-stymptom cold and cough relief Acetaminophen, Dextromathorphan HBr, Gauifenesin, Phenylephrine HCl CAPSULE, COATED ORAL 20070222 20181104 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 11673-647_9756e615-e7e8-417b-b89c-2faf4c541a07 11673-647 HUMAN OTC DRUG up and up ibuprofen Ibuprofen TABLET, COATED ORAL 20090528 ANDA ANDA072096 Target Corporation IBUPROFEN 200 mg/1 N 20181231 11673-649_553fd839-55ef-4a24-8cdd-15bc2de1a649 11673-649 HUMAN OTC DRUG severe cold and flu daytime/nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl KIT 20150801 OTC MONOGRAPH FINAL part341 Target Corporation N 20181231 11673-649_7b86e3dd-db4a-4f73-a51e-ec45e0061331 11673-649 HUMAN OTC DRUG severe cold and flu daytime/nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl KIT 20150801 OTC MONOGRAPH FINAL part341 Target Corporation N 20181231 11673-652_96da2b3a-1155-48be-876a-65f4a875d378 11673-652 HUMAN OTC DRUG up and up nicotine Nicotine polacrilex GUM, CHEWING ORAL 20160318 ANDA ANDA078968 Target Corporation NICOTINE 4 mg/1 N 20181231 11673-654_9a272d3c-33b2-4def-a4c8-11b427deab75 11673-654 HUMAN OTC DRUG sleep aid nighttime Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH FINAL part338 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 11673-656_be59e1bb-7448-481c-841d-d2d77e2eca7c 11673-656 HUMAN OTC DRUG Up and Up Cold Flu Relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20090707 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 11673-657_75b9c108-3726-4a9d-9900-86d6d5ee4635 11673-657 HUMAN OTC DRUG NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING ORAL 20100215 NDA NDA018612 Target Corporation NICOTINE 2 mg/1 N 20181231 11673-658_75b9c108-3726-4a9d-9900-86d6d5ee4635 11673-658 HUMAN OTC DRUG NICOTINE POLACRILEX nicotine polacrilex GUM, CHEWING ORAL 20100215 NDA NDA020066 Target Corporation NICOTINE 4 mg/1 N 20181231 11673-660_15b79de8-5488-4166-938a-4b82c9e5bbe4 11673-660 HUMAN OTC DRUG up and up childrens ibuprofen Ibuprofen SUSPENSION ORAL 20090708 ANDA ANDA074937 Target Corporation IBUPROFEN 100 mg/5mL N 20181231 11673-663_cddcd70f-b86f-4d74-82bf-682d3aca0351 11673-663 HUMAN OTC DRUG Crisp Apple Hand Sani Ethyl Alcohol LIQUID TOPICAL 20141005 OTC MONOGRAPH NOT FINAL part333A Target Corporation ALCOHOL 585 g/mL N 20181231 11673-664_9ab2353f-2325-4c85-9590-7e2aea72fabd 11673-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19930811 OTC MONOGRAPH NOT FINAL part356 Target Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11673-666_5f4a34cb-d8fe-47fa-8f48-8dbd665b5def 11673-666 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20171130 OTC MONOGRAPH NOT FINAL part334 Target Corp MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 11673-667_d14480ea-aee9-42cc-a1d7-4ad842a094c7 11673-667 HUMAN OTC DRUG cough suppressant and topical analgesic Camphor, Eucalyptus oil, Menthol OINTMENT TOPICAL 20090127 OTC MONOGRAPH FINAL part341 Target Corporation CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 48; 12; 26 mg/g; mg/g; mg/g N 20191231 11673-668_cd13223a-4b02-4956-84e6-402a72dcf458 11673-668 HUMAN OTC DRUG up and up fiber therapy Natural Fiber Psyllium Husk POWDER ORAL 20151026 OTC MONOGRAPH NOT FINAL part334 Target Corporation PSYLLIUM HUSK 3.4 g/12g N 20181231 11673-669_40ede692-213b-4e01-9a9a-7bf7b12c27bf 11673-669 HUMAN OTC DRUG up and up fiber therapy Psyllium Husk POWDER ORAL 20151026 OTC MONOGRAPH NOT FINAL part334 Target Corporation PSYLLIUM HUSK 3.4 g/5.79g N 20181231 11673-675_8ddeac78-ce53-49a4-979b-ca8403c15b11 11673-675 HUMAN OTC DRUG Medicated Pads witch hazel SOLUTION TOPICAL 20071001 OTC MONOGRAPH FINAL part346 Target Corporation WITCH HAZEL .5 mL/mL E 20171231 11673-677_f1e4650b-4200-4a88-91f9-d900be90b81f 11673-677 HUMAN OTC DRUG Severe Cold and Flu nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl TABLET, FILM COATED ORAL 20150801 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 11673-678_e4979c9f-ea5b-4f62-9f14-442162a84f11 11673-678 HUMAN OTC DRUG Stool Softener Laxative DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170831 OTC MONOGRAPH NOT FINAL part334 TARGET Corporation DOCUSATE SODIUM 100 mg/1 N 20181231 11673-680_5f8d82d2-edfb-4089-e053-2991aa0a3212 11673-680 HUMAN OTC DRUG Up and Up Sensitive Maximum Strength Mint Potassium Nitrate, and Sodium Fluoride PASTE ORAL 20151224 OTC MONOGRAPH NOT FINAL part356 Target Corporation POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 11673-682_5fa2cad9-3ec7-0095-e053-2a91aa0a18f9 11673-682 HUMAN OTC DRUG Up and Up Sensitive Maximum Strength Whitening Potassium nitrate, and Sodium fluoride PASTE ORAL 20151224 OTC MONOGRAPH NOT FINAL part356 Target Corporation POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 11673-685_b99f3447-0a91-4118-92f1-e6fd3f0c9a27 11673-685 HUMAN OTC DRUG up and up ibuprofen Ibuprofen SUSPENSION ORAL 20090710 ANDA ANDA074937 Target Corporation IBUPROFEN 100 mg/5mL N 20181231 11673-690_4fedb6b4-8104-45d5-9104-de1f03575444 11673-690 HUMAN OTC DRUG up and up allergy relief Diphenhydramine Hydrochloride TABLET ORAL 20090612 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 11673-694_32cae022-9c82-414e-9cf7-ea41c14c04e0 11673-694 HUMAN OTC DRUG Daytime Sinus Nighttime Sinus Maximum Strength acetaminophen, diphenhydramine HCl, guaifenesin, phenylephrine HCl KIT 20170701 OTC MONOGRAPH FINAL part341 Target Corporation N 20181231 11673-695_32f9202f-4c78-4dca-9633-819253aef349 11673-695 HUMAN OTC DRUG Up and Up nighttime cough control dextromethorphan hbr, doxylamine succinate SOLUTION ORAL 20160711 OTC MONOGRAPH FINAL part341 Target Corporation DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL N 20181231 11673-701_62dc70ea-1c97-40d3-b1c3-ada85983e670 11673-701 HUMAN OTC DRUG up and up daytime nighttime cold and flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140730 OTC MONOGRAPH FINAL part341 Target Corporation N 20181231 11673-702_d8f4a908-55c1-4629-8273-428c4b64f29e 11673-702 HUMAN OTC DRUG up and up chewable aspirin Aspirin TABLET, CHEWABLE ORAL 20150909 OTC MONOGRAPH NOT FINAL part343 Target Corporation ASPIRIN 81 mg/1 N 20181231 11673-705_1d19d50d-ae45-47ef-b9f9-43f9eb01d0c5 11673-705 HUMAN OTC DRUG up and up allergy relief cetirizine Hydrochloride SOLUTION ORAL 20141223 ANDA ANDA090254 Target Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 11673-707_faa00c30-42cf-4b90-a393-81aaecde5acc 11673-707 HUMAN OTC DRUG up and up hair regrowth treatment for men Minoxidil AEROSOL, FOAM TOPICAL 20150814 ANDA ANDA091344 Target Corporation MINOXIDIL 5 g/100g N 20181231 11673-710_803d661c-5c62-4e07-a850-731443b34804 11673-710 HUMAN OTC DRUG up and up dye-free childrens allergy Diphenhydramine hydrochloride SYRUP ORAL 20150915 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 11673-710_e3a3faf3-0467-44ae-b41d-f9c22c11f74b 11673-710 HUMAN OTC DRUG Up and Up Daytime Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150212 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 11673-717_155eb7fc-e891-4b07-a475-bd7343501898 11673-717 HUMAN OTC DRUG Up and Up Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20170118 ANDA ANDA078104 Target Corporation TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 11673-720_39bd8a94-0e5b-4a57-a032-30d4adb8fca4 11673-720 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150630 OTC MONOGRAPH FINAL part336 TARGET Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 11673-722_de29d0ac-6dd3-4893-b43e-acca42ec9f8e 11673-722 HUMAN OTC DRUG ANTACID calcium carbonate TABLET ORAL 20130308 20180630 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 1000 mg/1 E 20171231 11673-726_34b6d61f-17c4-41da-b4a0-6024a80caff7 11673-726 HUMAN OTC DRUG ANTACID extra strength calcium carbonate TABLET, CHEWABLE ORAL 20140310 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 11673-730_0d1771df-d51c-4da6-b8ca-f8aacce5b9df 11673-730 HUMAN OTC DRUG up and up nighttime sleep-aid DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20151020 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 11673-733_0d8a9f95-982e-4a00-9dc0-49147da27276 11673-733 HUMAN OTC DRUG Up and Up Cold Flu Relief Day Night Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140818 OTC MONOGRAPH FINAL part341 Target Corporation N 20181231 11673-734_edc33e57-143c-4a8c-bbda-67b01cfcdb60 11673-734 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex LOZENGE ORAL 20130313 ANDA ANDA203690 Target Corporation NICOTINE 2 mg/1 N 20181231 11673-735_e8f206ee-22d3-488b-9dc3-65b20b3a7209 11673-735 HUMAN OTC DRUG Up and Up Mucus Relief DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160720 ANDA ANDA091070 Target Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 11673-737_9c9ac383-7da3-4d22-bf51-c1468a17443b 11673-737 HUMAN OTC DRUG Up and Up Miconazole 1 Miconazole nitrate KIT 20170125 ANDA ANDA079114 Target Corporation N 20181231 11673-738_f007beaa-b108-46d5-8a98-853f011a8e2e 11673-738 HUMAN OTC DRUG Up and Up maximum Strength fast mucus relief Severe Congestion and Cough dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride LIQUID ORAL 20151110 OTC MONOGRAPH FINAL part341 Target Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 11673-742_3d01e310-85d4-46a4-b16c-6b236d8951f4 11673-742 HUMAN OTC DRUG Up and Up Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20110105 NDA NDA021920 Target Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 11673-747_38fd3774-1889-41c0-b090-4ab29dc9a2ba 11673-747 HUMAN OTC DRUG Up and Up mucus relief severe congestion and cough Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20170802 OTC MONOGRAPH FINAL part341 Target Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 11673-759_8cac4665-aee1-4c6b-9fd3-719f0861b152 11673-759 HUMAN OTC DRUG up and up childrens acetaminophen Acetaminophen SUSPENSION ORAL 20110716 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 11673-787_ec19c915-8d41-45d4-939c-15baa893fa23 11673-787 HUMAN OTC DRUG Tension Headache Relief Acetaminophen, Caffeine CAPSULE, GELATIN COATED ORAL 20090209 20181104 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 E 20171231 11673-788_f8ba3b90-272e-41a9-ac23-afe7ff0a4fc5 11673-788 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin, Caffeine CAPSULE, GELATIN COATED ORAL 20090109 20181104 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 E 20171231 11673-800_9d68c731-3fa5-4447-8366-c235cab5a096 11673-800 HUMAN OTC DRUG up and up allergy relief Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20150325 ANDA ANDA076447 Target Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 11673-801_5cd5fd09-ae22-434c-a175-2b2e87b7ccf0 11673-801 HUMAN OTC DRUG Antibacterial Body Wash Moisturizing Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E Target Corporation TRICLOSAN .15 mL/100mL N 20181231 11673-803_82108baf-ce6f-477e-9a35-56f83af1ea64 11673-803 HUMAN OTC DRUG Up and Up Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140730 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 11673-804_67930d2e-93ca-4342-872b-4b0678268b23 11673-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19961212 OTC MONOGRAPH NOT FINAL part333A Target Corp ISOPROPYL ALCOHOL .91 mg/mL N 20181231 11673-808_a5521bcd-bbdf-47c4-a125-fede13583432 11673-808 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20120806 OTC MONOGRAPH NOT FINAL part333A Target Corp TRICLOSAN .46 mg/mL N 20181231 11673-809_6d8cc502-22ba-4520-8fcb-2ae21a77413a 11673-809 HUMAN OTC DRUG Up and Up alcohol Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Target Corporation ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 11673-810_fe48f8bd-77f0-487b-b24f-217a3601fd62 11673-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Target Corp., ISOPROPYL ALCOHOL 500 mg/mL N 20181231 11673-811_5e755d65-d36f-4609-9103-45d0c1dbd43b 11673-811 HUMAN OTC DRUG Kids Foaming Hand Sanitizer Alcohol Free Benzalkonium chloride LIQUID TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part333A Target Brands BENZALKONIUM CHLORIDE .13 g/mL E 20171231 11673-812_5e952aa5-76fb-421b-a5dc-5aa2a4b93fe6 11673-812 HUMAN OTC DRUG Kids Foaming Hand Sanitizer Alcohol Free Benzalkonium chloride LIQUID TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part333A Target Brands BENZALKONIUM CHLORIDE .13 g/mL E 20171231 11673-815_d7b15d1f-c21c-4eaa-a2a9-56abe37fd5c2 11673-815 HUMAN OTC DRUG UP AND UP MOISTURIZING BODY WASH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140305 OTC MONOGRAPH NOT FINAL part333E TARGET CORPORATION BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11673-816_dd0587aa-0ba6-4228-b544-f9c1c57c5bd2 11673-816 HUMAN OTC DRUG UP AND UP MOISTURIZING ANTIBACTERIAL BODY WASH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141221 OTC MONOGRAPH NOT FINAL part333E TARGET CORPORATION BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11673-818_5f8ebe0f-d893-93cb-e053-2a91aa0ac9b3 11673-818 HUMAN OTC DRUG Up and Up Hot and Cold Medicated Menthol PATCH TOPICAL 20150223 OTC MONOGRAPH NOT FINAL part348 Target Corp MENTHOL 50 mg/g N 20181231 11673-820_ca5c9f0c-b0ed-49a6-9199-d898cec79ba8 11673-820 HUMAN OTC DRUG Up and Up mucus relief cold, flu and sore throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20170802 OTC MONOGRAPH FINAL part341 Target Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 11673-822_43ed906a-cf46-4baf-8470-a80f6546c076 11673-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19980129 OTC MONOGRAPH FINAL part347 Target Corporation WITCH HAZEL 86 kg/100L N 20181231 11673-825_1a673c72-8de9-4061-9644-fdf46046699c 11673-825 HUMAN OTC DRUG up and up miconazole 7 Miconazole nitrate CREAM VAGINAL 20090826 ANDA ANDA074760 Target Corporation MICONAZOLE NITRATE 2 g/100g N 20181231 11673-831_5cfa4b39-4e75-4f1b-bc65-7c9b5376b4eb 11673-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19961212 OTC MONOGRAPH NOT FINAL part334 Target Corp MINERAL OIL 999 mg/mL N 20181231 11673-835_a619e3e8-4252-445e-82d1-a91bea1ee323 11673-835 HUMAN OTC DRUG Up and Up Ibuprofen Sodium Ibuprofen TABLET, FILM COATED ORAL 20170302 ANDA ANDA206581 Target Corporation IBUPROFEN SODIUM 256 mg/1 N 20181231 11673-836_a7d0fd71-6ed0-4fc5-8025-2035a762646c 11673-836 HUMAN OTC DRUG 2 in 1 Pyrithione zinc SHAMPOO TOPICAL 20130506 OTC MONOGRAPH FINAL part358H Target Corporation PYRITHIONE ZINC 10.3 mg/mL N 20181231 11673-837_f219d765-7ea8-4261-88cc-337c5a5ca84f 11673-837 HUMAN OTC DRUG Up and Up Daytime Severe Cold Nighttime Cold and Flu Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, diphenhydramine HCl KIT 20150325 OTC MONOGRAPH FINAL part341 Target Corporation N 20181231 11673-845_24bf9014-525d-49a9-a196-edebfea02e41 11673-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20070314 OTC MONOGRAPH FINAL part344 Target Corporation ISOPROPYL ALCOHOL 613 mg/mL N 20181231 11673-852_a829b5ad-9478-4514-8e92-f6047d98c7e4 11673-852 HUMAN OTC DRUG Up and Up Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130911 ANDA ANDA091429 Target Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 11673-854_7b4aa796-628e-4e53-9772-6f1102ef0ce6 11673-854 HUMAN OTC DRUG Up and Up Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20110216 ANDA ANDA078546 Target Corporation NICOTINE 4 mg/1 N 20181231 11673-855_db52ba5f-ee36-4de5-b0ab-1360a5f718b9 11673-855 HUMAN OTC DRUG Childrens Allergy Melts Diphenhydramine HCl TABLET, CHEWABLE ORAL 20090320 20190804 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 E 20171231 11673-856_6ade6331-f2df-4edc-9e56-f756998cbe9d 11673-856 HUMAN OTC DRUG Up and Up minoxidil Minoxidil SOLUTION TOPICAL 20090527 ANDA ANDA075357 Target Corporation MINOXIDIL 2 g/100mL N 20181231 11673-857_caaa6b79-98a1-4f9c-ba46-ff1474d09328 11673-857 HUMAN OTC DRUG up and up athletes foot Clotrimazole CREAM TOPICAL 20170606 OTC MONOGRAPH FINAL part333C Target Corporation CLOTRIMAZOLE 1 g/100g N 20181231 11673-866_e8a2025f-3677-4a6d-bb3c-8edc89c87e88 11673-866 HUMAN OTC DRUG Up and up lice killing maximum strength Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20090822 OTC MONOGRAPH FINAL part358G Target Corporation PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL N 20181231 11673-871_f9c36d5d-110f-42be-86b9-c5c4fb775ed1 11673-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Target Corp HYDROGEN PEROXIDE 30 mg/mL N 20181231 11673-873_a5e09a6e-ae04-46fb-bea8-bbf007ee8822 11673-873 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex LOZENGE ORAL 20090701 ANDA ANDA077007 Target Corporation NICOTINE 4 mg/1 N 20181231 11673-876_4f87457d-4ccb-4f6a-8b9c-1129a8455dc5 11673-876 HUMAN OTC DRUG up and up ranitidine Ranitidine TABLET, COATED ORAL 20160502 ANDA ANDA076195 Target Corporation RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 11673-878_6126c47a-0d33-4a86-ba38-9ce48e750ed6 11673-878 HUMAN OTC DRUG Up and Up Anti Itch Hydrocortisone LOTION TOPICAL 20130612 OTC MONOGRAPH NOT FINAL part348 Target Corporation HYDROCORTISONE 1 g/100g N 20181231 11673-882_7613d4a6-78b1-4bf2-bd74-fe1065d5ce93 11673-882 HUMAN OTC DRUG Up and Up Infants Gas Relief Simethicone EMULSION ORAL 20090721 OTC MONOGRAPH FINAL part332 Target Corporation DIMETHICONE 20 mg/.3mL N 20181231 11673-898_717e5d5b-4bf7-415e-b259-44056bc96d8b 11673-898 HUMAN OTC DRUG up and up esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170922 ANDA ANDA207193 Target Corporation ESOMEPRAZOLE 20 mg/1 N 20181231 11673-900_11433034-23e8-4a88-8c59-d3a133be3766 11673-900 HUMAN OTC DRUG Up and Up anti diarrheal loperamide HCl SUSPENSION ORAL 20160226 ANDA ANDA091292 Target Corporation LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 11673-902_4e707a0b-f83e-42de-a0c4-6d18ef96002d 11673-902 HUMAN OTC DRUG up and up extra strength antacid 750 Assorted Berry Antacid Tablets TABLET, CHEWABLE ORAL 20151012 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 N 20191231 11673-902_7b66e95d-fcf1-40ed-b05f-7f72c4167a65 11673-902 HUMAN OTC DRUG up and up extra strength antacid 750 Assorted Berry Antacid Tablets TABLET, CHEWABLE ORAL 20150928 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 N 20191231 11673-902_be5af668-d97e-4c9c-b275-7ad552f4b912 11673-902 HUMAN OTC DRUG up and up extra strength antacid 750 Tropical Fruit Antacid Tablets TABLET, CHEWABLE ORAL 20151026 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 750 mg/1 N 20191231 11673-903_3bd4fc82-ce77-43e6-bc0c-bc9057b571c5 11673-903 HUMAN OTC DRUG up and up ultra strength antacid Assorted Fruit Antacid Tablets TABLET, CHEWABLE ORAL 20151022 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 1000 mg/1 N 20191231 11673-910_36c6710c-af15-418e-a0c8-136638befa47 11673-910 HUMAN OTC DRUG UpandUp Clotrimazole Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Target Corporation CLOTRIMAZOLE 10 mg/g N 20181231 11673-912_6dcc5f0c-a201-4692-8124-ab7a7a9fbf57 11673-912 HUMAN OTC DRUG Target antifungal Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Target Corporation TOLNAFTATE 10 mg/g N 20181231 11673-914_e630c2f5-b0ee-410a-91d2-5d321c925c30 11673-914 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Target Corporation LORATADINE 5 mg/5mL N 20181231 11673-915_2f64b9d9-bcf2-4faf-a113-02c7ab44fa19 11673-915 HUMAN OTC DRUG up and up omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20090714 NDA NDA022032 Target Corporation OMEPRAZOLE 20 mg/1 N 20181231 11673-929_ce672c2d-8395-4ef4-9008-a0c5f7f0076c 11673-929 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, FILM COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 Target Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 11673-932_7907153d-bd99-4854-99ab-b74c1b0f189f 11673-932 HUMAN OTC DRUG mucus relief guaifenesin TABLET, FILM COATED ORAL 20051222 20190708 OTC MONOGRAPH FINAL part341 Target Corporation GUAIFENESIN 400 mg/1 E 20171231 11673-933_2125e81b-23c6-4c5f-a6aa-829f8d3df71f 11673-933 HUMAN OTC DRUG ultra strength antacid Antacid TABLET, CHEWABLE ORAL 20180105 OTC MONOGRAPH FINAL part331 Target Corporation CALCIUM CARBONATE 1000 mg/1 N 20181231 11673-935_c38a6bd8-f27a-4644-87c9-9a230f98b245 11673-935 HUMAN OTC DRUG Up and Up nasal Oxymetazoline hydrochloride SPRAY NASAL 20160711 OTC MONOGRAPH FINAL part341 Target Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 11673-942_ec20ea00-a1d0-4527-b842-e02fba66d31f 11673-942 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20170110 OTC MONOGRAPH NOT FINAL part333A Target Corp BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 11673-944_5f6df381-36d5-4cd5-9a32-f6e6f7374c71 11673-944 HUMAN OTC DRUG Up and Up Hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20140604 OTC MONOGRAPH FINAL part346 Target Corporation GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 11673-951_db1030aa-2cff-42cc-9778-30adc39d6b50 11673-951 HUMAN OTC DRUG Instant Hand sanitizer ALCOHOL GEL TOPICAL 20110513 OTC MONOGRAPH NOT FINAL part333A Target ALCOHOL 65 kg/100L N 20181231 11673-952_78438556-d237-4ae0-b446-836d4f7cff0f 11673-952 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Target Corporation MENTHOL 1.5 mg/g N 20181231 11673-954_9e9627b6-e4b1-44d9-859d-d22119cd3da9 11673-954 HUMAN OTC DRUG Fresh Citrus TRICLOSAN SOAP TOPICAL 20090512 OTC MONOGRAPH NOT FINAL part333A Target Corp. TRICLOSAN .115 kg/100L N 20181231 11673-957_448a92ee-5f5d-467b-acb8-f25d4d5ab70e 11673-957 HUMAN OTC DRUG Up and Up Nicotine Nicotine Polacrilex LOZENGE ORAL 20130313 ANDA ANDA203690 Target Corporation NICOTINE 4 mg/1 N 20191231 11673-962_b2d79e3a-b0e3-4573-8269-fa595cb26a2f 11673-962 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20120210 OTC MONOGRAPH NOT FINAL part333A Target Corp TRICLOSAN .46 mg/mL N 20181231 11673-963_0b4cb3ce-dec5-470c-8640-1d32af75c152 11673-963 HUMAN OTC DRUG Menstrual Relief Multi-Symptom Acetaminophen, Pamabrom and Pyrilamine maleate TABLET, FILM COATED ORAL 20000620 20190119 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 E 20171231 11673-966_842bf57f-cbd0-49c4-8c02-80f970ce0fc3 11673-966 HUMAN OTC DRUG up and up acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150318 ANDA ANDA075077 Target Corporation ACETAMINOPHEN 650 mg/1 N 20181231 11673-967_42ce3e5e-db34-40a2-9d31-4f56176bd1de 11673-967 HUMAN OTC DRUG Menstrual Relief acetaminophen, pamabrom, pyrilamine maleate TABLET, FILM COATED ORAL 20150113 OTC MONOGRAPH NOT FINAL part343 Target Corporation ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 11673-982_fdca8a07-1d93-4f45-b8f3-aaceb9468466 11673-982 HUMAN OTC DRUG Up and Up Miconazole 3 Miconazole nitrate KIT 20090812 ANDA ANDA076357 Target Corporation N 20181231 11695-1403_bf900a90-9ece-4bbb-9a72-6f7e5c04e202 11695-1403 HUMAN PRESCRIPTION DRUG NEO-POLY-DEX Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 Butler Animal Health Supply NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 11695-1405_38ea57fe-ecfd-43d7-b992-0941cfb3f795 11695-1405 HUMAN PRESCRIPTION DRUG NEO-POLY-BAC Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 Butler Animal Health Supply NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] E 20171231 11695-1406_6541631a-6c77-44fc-b6ac-3b91e42e3065 11695-1406 HUMAN PRESCRIPTION DRUG NEO-POLY-BAC HYDRO Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 19951030 ANDA ANDA064068 Butler Animal Health Supply NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE 3.5; 10000; 400; 10 mg/g; [USP'U]/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 11695-1411_0de5bcce-0cc2-4b49-bd0d-714f1c7ec3bf 11695-1411 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19960726 ANDA ANDA040069 Butler Animal Health Supply DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 11695-1431_21092699-6ba7-42d2-b148-66a669084bc6 11695-1431 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS OPHTHALMIC 19940729 ANDA ANDA040070 Butler Animal Health Supply PREDNISOLONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 11695-1436_ca8900f2-cf16-425c-91f3-c41f8296358f 11695-1436 HUMAN PRESCRIPTION DRUG NEO-POLY-DEX Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 19940725 ANDA ANDA064063 Butler Animal Health Supply NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 11697-199_6f7c5e65-6ad1-431f-a801-7aa79fd40926 11697-199 HUMAN OTC DRUG Aloe Sunscreen Homosalate, Octisalate, Avobenzone, Ensulizole and Octocrylene LOTION TOPICAL 20110406 OTC MONOGRAPH NOT FINAL part352 Aloe Vera of America, Inc. HOMOSALATE; OCTISALATE; AVOBENZONE; ENSULIZOLE; OCTOCRYLENE 10; 5; 2.5; 3; 2.79 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 11697-318_47e35750-9678-4cd2-af27-e00fcfd4d3e4 11697-318 HUMAN OTC DRUG Forever Hand Sanitizer Hand Sanitizer Alcohol GEL TOPICAL 20100816 OTC MONOGRAPH NOT FINAL part333E Aloe Vera of America, Inc. ALCOHOL 36.58 mL/59mL N 20181231 11697-318_61304306-da31-5c75-e053-2a91aa0a7c6b 11697-318 HUMAN OTC DRUG Forever Hand Sanitizer Hand Sanitizer Alcohol GEL TOPICAL 20100816 OTC MONOGRAPH NOT FINAL part333E Aloe Vera of America, Inc. ALCOHOL 36.58 mL/59mL N 20181231 11697-319_50c98089-b653-428f-bb12-5cd65b50b9a8 11697-319 HUMAN OTC DRUG Aloe Sunscreen Homosalate, Octisalate, Avobenzone, Ensulizole anf Octocrylene SPRAY TOPICAL 20100816 OTC MONOGRAPH NOT FINAL part352 Aloe Vera of America, Inc. HOMOSALATE; OCTISALATE; ENSULIZOLE; AVOBENZONE; OCTOCRYLENE 10; 5; 4; 3; 2.79 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 11697-371_7b0aee80-cf83-4852-b531-3aba12fcc4b3 11697-371 HUMAN OTC DRUG Flawless by Sonya Aloe BB Creme Nude TITANIUM DIOXIDE CREAM TOPICAL 20140112 OTC MONOGRAPH NOT FINAL part352 Aloe Vera of America, Inc. TITANIUM DIOXIDE 3.15 g/45g E 20171231 11697-372_93e8ed77-99db-4326-9e75-2c1b6a71aa89 11697-372 HUMAN OTC DRUG Flawless by Sonya Aloe BB Creme Sandy Titanium Dioxide CREAM TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Aloe Vera of America, Inc. TITANIUM DIOXIDE 3.168 g/45g E 20171231 11697-373_40f0d8fc-d934-4156-8f49-7ec4e266c6b6 11697-373 HUMAN OTC DRUG Flawless by Sonya Aloe BB Creme Cocoa Titanium Dioxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Aloe Vera of America, Inc. TITANIUM DIOXIDE 1.35 g/45g E 20171231 11697-462_6c629c19-639c-4c7f-a69f-e7fbbce5cee9 11697-462 HUMAN OTC DRUG Forever Sun Lips Sunscreen LIPSTICK TOPICAL 20140425 OTC MONOGRAPH NOT FINAL part352 Aloe Vera of America, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; PETROLATUM .1275; .425; .2125; .1186; 1.615 g/4.25g; g/4.25g; g/4.25g; g/4.25g; g/4.25g E 20171231 11701-018_e1171fb6-2f8f-4a59-af89-255ccc19e56c 11701-018 HUMAN OTC DRUG Gentle Rain Antibacterial Triclosan SHAMPOO TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC TRICLOSAN 3 mL/1000mL E 20171231 11701-020_0c76d9f5-4a95-47ec-92b3-9bff0100478c 11701-020 HUMAN OTC DRUG Bedside-Care Benzethonium chloride SHAMPOO TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC BENZETHONIUM CHLORIDE 1 mL/1000mL E 20171231 11701-025_bae9cdd7-324e-4f1d-a447-e210b4edeaee 11701-025 HUMAN OTC DRUG Isagel B-I-B Alcohol GEL TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC ALCOHOL 600 mL/1000mL E 20171231 11701-025_f8690c82-4c50-42e9-97c8-7121499c436f 11701-025 HUMAN OTC DRUG Isagel Alcohol GEL TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC ALCOHOL 600 mL/1000mL E 20171231 11701-038_07fe298c-cb39-45d8-9544-4ac73e993f22 11701-038 HUMAN OTC DRUG Micro-Guard (AF) Miconazole Nitrate POWDER TOPICAL 20090615 OTC MONOGRAPH FINAL part333C Coloplast Manufacturing US, LLC MICONAZOLE NITRATE 20 mg/g E 20171231 11701-045_b5fc1620-6fa7-4bbf-8f40-9e000c070236 11701-045 HUMAN OTC DRUG Baza Antifungal Miconazole nitrate CREAM TOPICAL 20090615 OTC MONOGRAPH FINAL part333C Coloplast Manufacturing US, LLC MICONAZOLE NITRATE 20 mg/g E 20171231 11701-046_43ad527c-244f-47a7-994c-0378a00df14f 11701-046 HUMAN OTC DRUG Baza Protect Zinc oxide and Dimethicone CREAM TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part347 Coloplast Manufacturing US, LLC ZINC OXIDE; DIMETHICONE 120; 10 mg/g; mg/g E 20171231 11701-047_2401e719-c14a-4821-ad45-646f86a8fb9f 11701-047 HUMAN OTC DRUG Baza Cleanse and Protect Dimethicone LOTION TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part347 Coloplast Manufacturing US, LLC DIMETHICONE 20 mg/g E 20171231 11701-048_b8033d35-4a95-42d0-9c84-43d873aef9a4 11701-048 HUMAN OTC DRUG Baza Clear Petrolatum OINTMENT TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part347 Coloplast Manufacturing US, LLC PETROLATUM 960 mg/g E 20171231 11701-050_39de6937-9de3-4b82-83b1-b4d944ccb363 11701-050 HUMAN OTC DRUG Critic Aid Skin Zinc oxide PASTE TOPICAL 20090615 OTC MONOGRAPH FINAL part346 Coloplast Manufacturing US, LLC ZINC OXIDE 200 mg/g E 20171231 11701-052_bdd5b868-8258-4f8d-8312-fdfb76fd9b31 11701-052 HUMAN OTC DRUG Bedside-Care Foam (Alcohol Free) Benzethonium chloride SHAMPOO TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC BENZETHONIUM CHLORIDE 100 mg/100mL E 20171231 11701-053_20af33a0-4a04-4a6b-83f7-f8bd8edc0d99 11701-053 HUMAN OTC DRUG Bedside-Care Benzethonium chloride SHAMPOO TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC BENZETHONIUM CHLORIDE 100 mg/100mL E 20171231 11701-059_af2cb1f8-f41b-470b-868c-edd654a970af 11701-059 HUMAN OTC DRUG Bedside-Care Perineal Wash Benzethonium chloride LIQUID TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part333E Coloplast Manufacturing US, LLC BENZETHONIUM CHLORIDE 1 mL/L E 20171231 11701-062_58cfa69c-02e4-4e88-bfb2-7fc1ccc9f0b6 11701-062 HUMAN OTC DRUG Baza Cleanse and Protect Odor Control Dimethicone LOTION TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part347 Coloplast Manufacturing US, LLC DIMETHICONE 20 mg/g E 20171231 11701-063_dace7baf-46f4-420e-a4b9-0d264a9606b2 11701-063 HUMAN OTC DRUG Sween 24 DIMETHICONE CREAM TOPICAL 20090615 OTC MONOGRAPH FINAL part347 Coloplast Manufacturing US, LLC DIMETHICONE 60 mg/g E 20171231 11701-066_2659e763-1867-435c-b160-ba3001c034b8 11701-066 HUMAN OTC DRUG Critic Aid Clear Petrolatum OINTMENT TOPICAL 20090615 OTC MONOGRAPH NOT FINAL part347 Coloplast Manufacturing US, LLC PETROLATUM 710 mg/g E 20171231 11701-067_1b526080-40ba-48cf-92fe-216d12a9f224 11701-067 HUMAN OTC DRUG Critic Aid Clear AF Miconazole Nitrate OINTMENT TOPICAL 20090615 OTC MONOGRAPH FINAL part333C Coloplast Manufacturing US, LLC MICONAZOLE NITRATE 20 mg/g E 20171231 11704-104_f3b5bce4-0f86-482c-94a3-8d87f459a541 11704-104 HUMAN PRESCRIPTION DRUG AtroPen Auto-Injector Atropine sulfate INJECTION INTRAMUSCULAR 20030619 NDA NDA017106 Meridian Medical Technologies, Inc. ATROPINE SULFATE .5 mg/.7mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 11704-105_f3b5bce4-0f86-482c-94a3-8d87f459a541 11704-105 HUMAN PRESCRIPTION DRUG AtroPen Auto-Injector Atropine sulfate INJECTION INTRAMUSCULAR 20030619 NDA NDA017106 Meridian Medical Technologies, Inc. ATROPINE SULFATE 1 mg/.7mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 11704-106_f3b5bce4-0f86-482c-94a3-8d87f459a541 11704-106 HUMAN PRESCRIPTION DRUG AtroPen Auto-Injector Atropine sulfate INJECTION INTRAMUSCULAR 20030619 NDA NDA017106 Meridian Medical Technologies, Inc. ATROPINE SULFATE 2 mg/.7mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 11704-107_f3b5bce4-0f86-482c-94a3-8d87f459a541 11704-107 HUMAN PRESCRIPTION DRUG AtroPen Auto-Injector Atropine sulfate INJECTION INTRAMUSCULAR 20040917 NDA NDA017106 Meridian Medical Technologies, Inc. ATROPINE SULFATE .25 mg/.3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 11704-235_9e4564d7-6909-4dd9-add0-693bb45eaa01 11704-235 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAMUSCULAR 19900712 NDA NDA019999 Meridian Medical Technologies, Inc. MORPHINE SULFATE 10 mg/.7mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 11704-251_c7e5b5e2-5de7-4b70-89d8-92fc6c0d7c40 11704-251 HUMAN PRESCRIPTION DRUG Pralidoxime Chloride Pralidoxime Chloride INJECTION INTRAMUSCULAR 19830426 NDA NDA018986 Meridian Medical Technologies, Inc. PRALIDOXIME CHLORIDE 600 mg/2mL Cholinesterase Reactivator [EPC],Cholinesterase Reactivators [MoA] N 20181231 11704-370_f0246c36-f333-4c17-9f59-98e6a19de3e2 11704-370 HUMAN PRESCRIPTION DRUG Cyanokit Hydroxocobalamin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111001 NDA NDA022041 Meridian Medical Technologies, Inc. HYDROXOCOBALAMIN 5 g/250mL Antidote [EPC] N 20181231 11704-600_98929b54-7fad-4c46-a2c5-1619c83f12ad 11704-600 HUMAN PRESCRIPTION DRUG Diazepam diazepam INJECTION INTRAMUSCULAR 19901205 NDA NDA020124 Meridian Medical Technologies, Inc. DIAZEPAM 10 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 11704-620_b9fd2a14-5e73-4b46-aae3-ac2687bb6478 11704-620 HUMAN PRESCRIPTION DRUG DuoDote atropine and pralidoxime chloride KIT INTRAMUSCULAR 20060928 NDA NDA021983 Meridian Medical Technologies, Inc. N 20181231 11704-777_755922b7-5fd0-4d8c-9f4f-75dc63f295c2 11704-777 HUMAN PRESCRIPTION DRUG ATNAA atropine and pralidoxime chloride Auto-Injector atropine and pralidoxime chloride KIT INTRAMUSCULAR 20020117 NDA NDA021175 Meridian Medical Technologies, Inc. N 20181231 11716-0001_00637064-ea23-451f-be9b-73b1f5dcf896 11716-0001 HUMAN OTC DRUG GOODSENSE ARTIFICIAL TEARS POLYVINYL ALCOHOL SOLUTION OPHTHALMIC 20100722 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYVINYL ALCOHOL; POVIDONE 5; 6 mg/mL; mg/mL N 20181231 11716-0002_6bdd2b86-9fee-4d75-a7dd-3c43c65167d6 11716-0002 HUMAN OTC DRUG GOODSENSE ORIGINAL EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20141126 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 11716-0003_f12b0cbb-b8cf-4ce5-aa80-acc950cee090 11716-0003 HUMAN OTC DRUG GOODSENSE IRRITATION RELIEF EYE TETRAHYDROZOLINE HYDROCHLORIDE, AND ZINC SULFATE SOLUTION/ DROPS OPHTHALMIC 20100802 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL N 20181231 11716-0004_21ebdfe6-c527-460e-be39-95b9eb9dae78 11716-0004 HUMAN OTC DRUG GOODSENSE ADVANCED RELIEF EYE DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, AND TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 20100804 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11716-0041_90acc763-c7e6-4281-9e5c-04275289c1e9 11716-0041 HUMAN OTC DRUG GOODSENSE LUBRICATING EYE DROPS CARBOXYMETHYLCELLULOSE SODIUM SOLUTION OPHTHALMIC 20100730 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 11716-0042_ab78481d-d571-42ab-a375-f4421c7f83cd 11716-0042 HUMAN OTC DRUG GOODSENSE LUBRICANT EYE DROPS POLYETHYLENE GLYCOL 400 SOLUTION OPHTHALMIC 20100804 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL N 20181231 11716-0051_3d327878-155d-44c8-903b-c7d2ff227417 11716-0051 HUMAN OTC DRUG DG LUBRICANT EYE DROPS POLYETHYLENE GLYCOL 400 SOLUTION OPHTHALMIC 20100426 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL N 20181231 11716-0053_67fddf3f-80e0-4fda-84fc-c0154c0c2d42 11716-0053 HUMAN OTC DRUG DG HEALTH ORIGINAL TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20100812 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 11716-0101_2383b6cc-a845-4599-b785-d35391f88cbf 11716-0101 HUMAN OTC DRUG PREMIER VALUE ORIGINAL TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20140519 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 11716-0102_a6cd1636-a269-460b-bfb2-d29fb2fb97f0 11716-0102 HUMAN OTC DRUG PREMIER VALUE ADVANCED EYE DROPS DEXTRAN 70 SOLUTION OPHTHALMIC 20100812 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mL/mL; mL/mL; mL/mL; mL/mL N 20181231 11716-0103_f02c0b6e-3369-43fe-b992-0ad9d84f2191 11716-0103 HUMAN OTC DRUG PREMIER VALUE EYE AC TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE SOLUTION OPHTHALMIC 20101102 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL N 20181231 11716-0224_9ee77831-433d-425d-b3cc-f95773f53093 11716-0224 HUMAN OTC DRUG PREMIER VALUE EYE DROPS MT POLYVINYL ALCOHOL AND POVIDONE SOLUTION OPHTHALMIC 20101019 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYVINYL ALCOHOL; POVIDONE 5; 6 mg/mL; mg/mL N 20181231 11716-0458_cf47d75f-6acf-4e22-acd5-88c24d82754d 11716-0458 HUMAN OTC DRUG SHOPKO ADVANCED FORMULA EYE DROPS DEXTRAN 70 SOLUTION OPHTHALMIC 20100812 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mL/mL; mL/mL; mL/mL; mL/mL N 20181231 11716-0460_505ed84a-9943-43b3-9240-f47cb0a6ea3c 11716-0460 HUMAN OTC DRUG SHOPKO RELIEF TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE SOLUTION OPHTHALMIC 20101008 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL N 20181231 11716-1104_ddd93887-104b-4d41-8cdb-bf19ef9154a1 11716-1104 HUMAN OTC DRUG LEADER ADVANCED FORMULA EYE DROPS DEXTRAN 70 SOLUTION OPHTHALMIC 20100506 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mL/mL; mL/mL; mL/mL; mL/mL N 20181231 11716-1163_2fd8e64f-8fa0-43d6-b48d-a1246b7e557a 11716-1163 HUMAN OTC DRUG LEADER EYE ITCH RELIEF DROPS KETOTIFEN FUMARATE SOLUTION/ DROPS OPHTHALMIC 20100421 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. KETOTIFEN FUMARATE .345 mg/mL N 20181231 11716-1167_0fb24097-4d04-4fe4-ab58-da8b3c8cb57e 11716-1167 HUMAN OTC DRUG WALGREENS MAXIMUM RELIEF EYE DROPS DEXTRAN 70 SOLUTION OPHTHALMIC 20100526 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mL/mL; mL/mL; mL/mL; mL/mL N 20181231 11716-1168_b19af045-9365-4310-883d-8ae53c5866cb 11716-1168 HUMAN OTC DRUG WALGREENS ORIGINAL EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20100526 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 11716-1187_cb039152-7e0b-498a-9d68-aabd9a8e4c59 11716-1187 HUMAN OTC DRUG FREDS ORIGINAL EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20100514 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 11716-1188_f77c4ca9-319e-419e-a954-0e2ffa50bfe8 11716-1188 HUMAN OTC DRUG WALGREENS ARTIFICIAL TEARS EYE DROPS DEXTRAN 70 SOLUTION OPHTHALMIC 20100614 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; HYPROMELLOSE 2910 (4000 CPS) .001; .003 mL/mL; mL/mL N 20181231 11716-1189_50ac5f55-488a-4125-988f-86197f43fc01 11716-1189 HUMAN OTC DRUG FREDS DRY EYE RELIEF GLYCERIN SOLUTION OPHTHALMIC 20101206 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. GLYCERIN; POLYETHYLENE GLYCOL 400; HYPROMELLOSES .002; .01; .002 mL/mL; mL/mL; mL/mL N 20181231 11716-1191_9659dafe-c8e5-4bc9-89c7-a7c691cf29d0 11716-1191 HUMAN OTC DRUG LEADER LUBRICATING EYE DROPS CARBOXYMETHYLCELLULOSE SODIUM SOLUTION OPHTHALMIC 20100429 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 11716-1192_8a2dd2b4-e592-41a3-995f-c70427015383 11716-1192 HUMAN OTC DRUG LEADER LUBRICANT EYE DROPS POLYETHYLENE GLYCOL 400 SOLUTION OPHTHALMIC 20100428 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL N 20181231 11716-1609_5fa5becf-c2b7-48cc-a66d-e9f34683b542 11716-1609 HUMAN OTC DRUG SHOPKO ORIGINAL FORMULA EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20100812 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 11716-1629_babce0c4-1715-4831-9a4b-21d0c307e278 11716-1629 HUMAN OTC DRUG SHOPKO DRY EYE RELIEF GLYCERIN SOLUTION OPHTHALMIC 20100812 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. GLYCERIN; HYPROMELLOSE; POLYETHYLENE GLYCOL 400 .002; .002; .01 mL/mL; mL/mL; mL/mL N 20181231 11716-4060_5341e693-0555-4824-94ab-5e86345b231f 11716-4060 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY LUBRICANT EYE DROPS POLYETHYLENE GLYCOL 400 SOLUTION OPHTHALMIC 20100920 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL N 20181231 11716-4708_312b0852-6077-491f-ae04-3a079d9bb885 11716-4708 HUMAN OTC DRUG LEADER ORIGINAL FORMULA EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 20100322 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL CIV N 20181231 11716-7901_0270c386-37e0-4359-8892-16b099e0bad3 11716-7901 HUMAN OTC DRUG MEIJER LUBRICATING EYE DROPS CARBOXYMETHYLCELLULOSE SODIUM SOLUTION OPHTHALMIC 20100513 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 11716-8653_5efe000a-237c-01e9-e053-2a91aa0a48f9 11716-8653 HUMAN OTC DRUG CARE ONE EYE DROPS SEASONAL RELIEF TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE SOLUTION OPHTHALMIC 20101102 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL N 20181231 11716-9637_396900be-73f8-4ccf-ab2f-b188b8e80f5c 11716-9637 HUMAN OTC DRUG LEADER DRY EYE RELIEF DEXTRAN 70 SOLUTION OPHTHALMIC 20100712 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. DEXTRAN 70; HYPROMELLOSE 2910 (4000 CPS) .001; .003 mL/mL; mL/mL N 20181231 11716-9638_7ccb006e-809f-4f34-9695-f4e93fc39f51 11716-9638 HUMAN OTC DRUG LEADER RELIEF TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE SOLUTION OPHTHALMIC 20101008 OTC MONOGRAPH FINAL part349 HANLIM PHARM. CO., LTD. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL N 20181231 11727-006_403e414a-92e2-42a6-9539-aa7a9460e89d 11727-006 HUMAN OTC DRUG X-PEL Anti-Lice Apis Mellifica, Carbolicum Acidum, Ledum Palustre SHAMPOO TOPICAL 20140415 UNAPPROVED HOMEOPATHIC Dermedics Laboratories APIS MELLIFERA; PHENOL; LEDUM PALUSTRE TWIG 15; 15; 15 [hp_X]/170g; [hp_X]/170g; [hp_X]/170g E 20171231 11727-007_96a3db88-ce84-4a4b-b3d5-9151e7c16ca7 11727-007 HUMAN OTC DRUG X-PEL PURE Anti-Lice Apis Mellifica, Carbolicum Acidum, Ledum Palustre SHAMPOO TOPICAL 20140415 UNAPPROVED HOMEOPATHIC Dermedics Laboratories APIS MELLIFERA; PHENOL; LEDUM PALUSTRE TWIG 15; 15; 15 [hp_X]/170g; [hp_X]/170g; [hp_X]/170g E 20171231 11748-010_c031e1df-ccf0-4e9f-a4fd-b0ec0d242136 11748-010 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19880101 UNAPPROVED MEDICAL GAS P and J Oxyfill, LLC OXYGEN 99 L/100L N 20181231 11763-524_3b4d08e8-cc38-4d45-aa46-d326cef91685 11763-524 HUMAN PRESCRIPTION DRUG Fluorbon Drops Sodium Fluoride SOLUTION ORAL 19970716 UNAPPROVED DRUG OTHER KIRKMAN GROUP, INC. SODIUM FLUORIDE .55 mg/.6mL N 20181231 11788-001_5979dceb-aab5-6976-e053-2991aa0a61e5 11788-001 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20130718 ANDA ANDA091145 AiPing Pharmaceutical, Inc. FOLIC ACID 1 mg/1 N 20181231 11788-001_597a4fcf-9a5e-e27c-e053-2991aa0af1ce 11788-001 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20130718 ANDA ANDA091145 AiPing Pharmaceutical, Inc. FOLIC ACID 1 mg/1 N 20181231 11788-003_59b694b2-6f22-f17b-e053-2991aa0ab8b7 11788-003 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170508 ANDA ANDA207095 AiPing Pharmaceutical, Inc. IBUPROFEN 200 mg/1 N 20181231 11788-003_5bd8cf4a-096a-5a2a-e053-2a91aa0ad499 11788-003 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170508 ANDA ANDA207095 AiPing Pharmaceutical, Inc. IBUPROFEN 200 mg/1 N 20181231 11788-005_59b694b2-6f22-f17b-e053-2991aa0ab8b7 11788-005 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170508 ANDA ANDA207095 AiPing Pharmaceutical, Inc. IBUPROFEN 200 mg/1 N 20181231 11788-005_5bd8cf4a-096a-5a2a-e053-2a91aa0ad499 11788-005 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170508 ANDA ANDA207095 AiPing Pharmaceutical, Inc. IBUPROFEN 200 mg/1 N 20181231 11788-007_59b694b2-6f22-f17b-e053-2991aa0ab8b7 11788-007 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170508 ANDA ANDA207095 AiPing Pharmaceutical, Inc. IBUPROFEN 200 mg/1 N 20181231 11788-007_5bd8cf4a-096a-5a2a-e053-2a91aa0ad499 11788-007 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170508 ANDA ANDA207095 AiPing Pharmaceutical, Inc. IBUPROFEN 200 mg/1 N 20181231 11788-008_5ad1dba6-6ab1-5d91-e053-2991aa0a6388 11788-008 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET, FILM COATED ORAL 20161123 ANDA ANDA202413 AiPing Pharmaceutical Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 11788-008_5ad2129b-0fc1-43fb-e053-2991aa0a4d46 11788-008 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET, FILM COATED ORAL 20161123 ANDA ANDA202413 AiPing Pharmaceutical, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 11788-009_5ad1dba6-6ab1-5d91-e053-2991aa0a6388 11788-009 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET, FILM COATED ORAL 20161123 ANDA ANDA202413 AiPing Pharmaceutical Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 11788-009_5ad2129b-0fc1-43fb-e053-2991aa0a4d46 11788-009 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET, FILM COATED ORAL 20161123 ANDA ANDA202413 AiPing Pharmaceutical, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 11788-010_5ad1dba6-6ab1-5d91-e053-2991aa0a6388 11788-010 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET, FILM COATED ORAL 20161123 ANDA ANDA202413 AiPing Pharmaceutical Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 11788-010_5ad2129b-0fc1-43fb-e053-2991aa0a4d46 11788-010 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET, FILM COATED ORAL 20161123 ANDA ANDA202413 AiPing Pharmaceutical, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 11788-015_5a2f1711-e1b9-9ba9-e053-2991aa0a9105 11788-015 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH NOT FINAL part334 AiPing Pharmaceutical, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 11788-015_5d6b2c64-521c-6787-e053-2991aa0a1715 11788-015 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH NOT FINAL part334 AiPing Pharmaceutical, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 11788-016_5ae38bee-49e0-5827-e053-2991aa0ae355 11788-016 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH FINAL part341 AiPing Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 11788-016_63f1c372-2fc4-0318-e053-2991aa0afc80 11788-016 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH FINAL part341 AiPing Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 11788-017_5bd8cb5d-8fd6-0b1c-e053-2991aa0a1823 11788-017 HUMAN OTC DRUG Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH NOT FINAL part343 AiPing Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20191231 11788-017_6401b218-b7b8-2e2d-e053-2991aa0ae9c1 11788-017 HUMAN OTC DRUG Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH NOT FINAL part343 AiPing Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20191231 11788-018_5c649146-0258-0640-e053-2a91aa0a6cf4 11788-018 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH FINAL part341 AiPing Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 11788-018_5e71d180-1e82-e8ff-e053-2991aa0a3f4a 11788-018 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH FINAL part341 AiPing Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 11788-023_5c8aefee-6c77-ba92-e053-2a91aa0a3a82 11788-023 HUMAN OTC DRUG Allergy Softgel Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH FINAL part341 AiPing Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 11788-023_640274a1-324a-0e15-e053-2991aa0a3e06 11788-023 HUMAN OTC DRUG Allergy Softgel Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH FINAL part341 AiPing Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 11788-024_5a07ae7d-e80d-32ae-e053-2991aa0a9048 11788-024 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH NOT FINAL part334 AiPing Pharmaceutical, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 11788-024_5a1bb1fb-12a7-5fd1-e053-2991aa0a628b 11788-024 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH NOT FINAL part334 AiPing Pharmaceutical, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 11788-026_5c8aefee-6c86-ba92-e053-2a91aa0a3a82 11788-026 HUMAN OTC DRUG Nighttime Sleep-Aid Softgel Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH FINAL part338 AiPing Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/21 N 20191231 11788-026_6272e417-c964-0e7d-e053-2a91aa0a977e 11788-026 HUMAN OTC DRUG Nighttime Sleep-Aid Softgel Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH FINAL part338 AiPing Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/21 N 20191231 11788-031_598e9653-9313-3bfe-e053-2a91aa0afcbe 11788-031 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20170901 OTC MONOGRAPH FINAL part332 AiPing Pharmaceutical, Inc. DIMETHICONE 125 mg/1 N 20181231 11788-031_59b68451-1652-7858-e053-2991aa0a0892 11788-031 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20170901 OTC MONOGRAPH FINAL part332 AiPing Pharmaceutical, Inc. DIMETHICONE 125 mg/1 N 20181231 11788-032_598e9653-9312-3bfe-e053-2a91aa0afcbe 11788-032 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20170901 OTC MONOGRAPH FINAL part332 AiPing Pharmaceutical, Inc. DIMETHICONE 180 mg/1 N 20181231 11788-032_59b66cce-c074-6de6-e053-2a91aa0a6243 11788-032 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20170901 OTC MONOGRAPH FINAL part332 AiPing Pharmaceutical, Inc. DIMETHICONE 180 mg/1 N 20181231 11788-301_46c448f9-97b9-4172-8b4b-b1510bdb31a2 11788-301 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140130 OTC MONOGRAPH FINAL part343 AiPing Pharmaceutical Inc. ASPIRIN 81 mg/1 N 20181231 11788-302_e736fb46-fa12-4d81-94c9-3d420eb61b0a 11788-302 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140131 OTC MONOGRAPH FINAL part343 AiPing Pharmaceutical, Inc. ASPIRIN 325 mg/1 N 20181231 11819-282_4db8da08-120b-4098-b938-202075869844 11819-282 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 19830701 ANDA ANDA084442 HHS/Program Support Center/Supply Service Center PROBENECID 500 mg/1 E 20171231 11819-305_99c94f94-7630-4942-9c78-ea6b740e5d2b 11819-305 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20110617 ANDA ANDA062505 HHS/Program Support Center/Supply Service Center DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 11819-311_13c33778-3828-4a64-849a-5346cbeb264a 11819-311 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 HHS/Program Support Center/Supply Service Center DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 11819-323_dc9e0bf6-012f-47c2-8b54-a4a7a2530ed2 11819-323 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 HHS/Program Support Center/Supply Service Center CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 11819-342_ac8d96ed-3661-4b62-b4e2-c42c93042cf3 11819-342 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 HHS/Program Support Center/Supply Service Center LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA] E 20171231 11819-348_668c81b3-613a-4f70-8f9c-1272ca77a6fa 11819-348 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20110617 ANDA ANDA062505 HHS/Program Support Center/Supply Service Center DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 11819-351_29189c63-3b09-495d-bacc-d850da3a1a7e 11819-351 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 HHS/Program Support Center/Supply Service Center CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 11819-357_0e6315f2-49bd-471a-ab04-2949077728d0 11819-357 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 HHS/Program Support Center/Supply Service Center IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 11819-360_dd188c20-9c47-4713-bf17-e13ec7959da6 11819-360 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 HHS/Program Support Center/Supply Service Center CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 11819-363_9f2ae085-ffaf-4287-93f0-0d480c2516fd 11819-363 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20111222 ANDA ANDA075817 HHS/Program Support Center/Supply Service Center CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 11819-365_9ac5ef7b-9810-44b2-a5f6-07eac3feecc1 11819-365 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20110726 ANDA ANDA078139 HHS/Program Support Center/Supply Service Center ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 11822-0000_a1bca860-add9-411f-8c3b-da41faf6210b 11822-0000 HUMAN OTC DRUG Body Menthol POWDER TOPICAL 20131119 OTC MONOGRAPH NOT FINAL part348 Rite Aid MENTHOL 1.5 mg/g N 20181231 11822-0001_5b1b8e3e-02ed-4c80-ba69-4a6f72b1a27f 11822-0001 HUMAN OTC DRUG Rite Aid Anti-Cavity, Anti-Gingivitis Stannous Fluoride PASTE DENTAL 20101208 OTC MONOGRAPH FINAL part355 Rite Aid STANNOUS FLUORIDE 4.54 mg/g E 20171231 11822-0002_d76ff246-dfa0-496d-98e8-b21807eab6a2 11822-0002 HUMAN OTC DRUG Rite Aid Sensitive Mint Potassium Nirtate and Sodium Fluoride PASTE DENTAL 20100719 OTC MONOGRAPH NOT FINAL part356 Rite Aid POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g E 20171231 11822-0003_8f256f85-29b1-4acf-99ef-e7b92390e825 11822-0003 HUMAN OTC DRUG Double Antibiotic Bacitracin Zinc, Polymyxin B Sulfate OINTMENT TOPICAL 20060616 OTC MONOGRAPH FINAL part333B Rite Aid BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 11822-0004_5a97cfe3-9822-4659-9505-3ed087772688 11822-0004 HUMAN OTC DRUG Anticavity Fluoride Rinse Anticavity Fluoride MOUTHWASH ORAL 20040408 OTC MONOGRAPH FINAL part355 Rite Aid SODIUM FLUORIDE .05 mL/L N 20181231 11822-0005_c7ea22f0-9b85-4418-a7b6-08e019443219 11822-0005 HUMAN OTC DRUG hemorrhoidal relief cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20150109 OTC MONOGRAPH FINAL part346 Rite Aid Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 11822-0009_17c95510-947a-4d05-8940-ed7cc71c16f1 11822-0009 HUMAN OTC DRUG nicotine Nicotine Polacrilex LOZENGE ORAL 20150205 ANDA ANDA090711 Rite Aid Corporation NICOTINE 4 mg/1 N 20181231 11822-0010_2b557b22-7efa-409a-8fe7-c1923e41fce8 11822-0010 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20040506 ANDA ANDA076359 Rite Aid Corporation IBUPROFEN 100 mg/1 N 20181231 11822-0012_2c9d467c-675f-4b6e-a6f9-126e83515fb5 11822-0012 HUMAN OTC DRUG junior pain relief acetaminophen TABLET, CHEWABLE ORAL 20050225 20200606 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/1 N 20181231 11822-0013_7ee9a354-0dbe-4f2e-a301-45712d9372da 11822-0013 HUMAN OTC DRUG Allergy and Congestion Relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20130725 ANDA ANDA076050 Rite Aid Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 11822-0018_241b6494-5eff-45ee-a5a9-09c66e7d1b4f 11822-0018 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM Robitussin DM LIQUID ORAL 20131115 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 11822-0018_a6d49d02-4544-4833-8784-2c7313ef4336 11822-0018 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM Robitussin DM LIQUID ORAL 20131115 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 11822-0023_d31f071b-f8b5-4c36-8ded-58deab682fac 11822-0023 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130409 OTC MONOGRAPH NOT FINAL part333A Rite Aid ALCOHOL 700 mg/mL N 20181231 11822-0025_e513eb4e-bbdf-4a2f-a942-24c1faa1f7e8 11822-0025 HUMAN OTC DRUG Childrens Allergy Relief Benadryl LIQUID ORAL 20131118 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 11822-0028_69160de9-3fc0-4e95-bcf9-0455230d5988 11822-0028 HUMAN OTC DRUG UNDECYLENIC ACID UNDECYLENIC ACID LIQUID TOPICAL 20080601 OTC MONOGRAPH FINAL part333C RiteAid UNDECYLENIC ACID 288 mg/mL E 20171231 11822-0029_9506c1e9-791b-498e-b3fe-5034bf8d1bf2 11822-0029 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20160730 ANDA ANDA076775 Rite Aid Corporation NICOTINE 2 mg/1 N 20181231 11822-0030_4a9d9920-c79d-4396-e054-00144ff8d46c 11822-0030 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20130501 OTC MONOGRAPH FINAL part341 Rite Aid Corporation MENTHOL 5.4 mg/1 N 20181231 11822-0031_4aa03876-8a13-55f6-e054-00144ff8d46c 11822-0031 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20130501 OTC MONOGRAPH FINAL part341 Rite Aid MENTHOL 5.8 mg/1 N 20181231 11822-0032_4aa0a001-a63a-0d89-e054-00144ff88e88 11822-0032 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20150424 OTC MONOGRAPH FINAL part341 Rite Aid MENTHOL 5.4 mg/1 N 20181231 11822-0033_4aa166fb-f675-25ed-e054-00144ff88e88 11822-0033 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20150424 OTC MONOGRAPH FINAL part341 Rite Aid MENTHOL 5.8 mg/1 N 20181231 11822-0034_4aa21e89-b1fc-41b7-e054-00144ff8d46c 11822-0034 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20130501 OTC MONOGRAPH FINAL part341 Rite Aid MENTHOL 7.5 mg/1 N 20181231 11822-0035_4ab5c016-1be5-2973-e054-00144ff8d46c 11822-0035 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20150424 OTC MONOGRAPH FINAL part341 Rite Aid MENTHOL 7.5 mg/1 N 20181231 11822-0036_4adb61b3-0498-5810-e054-00144ff8d46c 11822-0036 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20150424 OTC MONOGRAPH FINAL part341 Rite Aid MENTHOL 7.5 mg/1 N 20181231 11822-0037_4b532179-d4e3-0add-e054-00144ff88e88 11822-0037 HUMAN OTC DRUG SF Cherry Cough Drops Menthol LOZENGE ORAL 20120118 OTC MONOGRAPH FINAL part341 Rite Aid MENTHOL 5.8 mg/1 N 20181231 11822-0038_4adbd66a-6b3b-046d-e054-00144ff8d46c 11822-0038 HUMAN OTC DRUG SF Honey Lemon Cough Drop Menthol LOZENGE ORAL 20110728 OTC MONOGRAPH FINAL part341 Rite Aid MENTHOL 7.6 mg/1 N 20181231 11822-0039_4b55307a-a643-4ca3-e054-00144ff88e88 11822-0039 HUMAN OTC DRUG SF Menthol Cough Drop Menthol LOZENGE ORAL 20150424 OTC MONOGRAPH FINAL part341 Rite Aid MENTHOL 5.8 mg/1 N 20181231 11822-0050_d48c0ad1-9ead-4e67-8644-4ea52029ab38 11822-0050 HUMAN OTC DRUG ibuprofen pm Diphenhydramine Citrate, Ibuprofen TABLET, FILM COATED ORAL 20090319 ANDA ANDA079113 Rite Aid Corporation DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 11822-0054_438e1514-a0a5-4d06-8be0-b93fcf1df374 11822-0054 HUMAN OTC DRUG Suphedrine Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020813 ANDA ANDA075153 Rite Aid Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 11822-0056_cc470ff0-824d-417a-a994-ed34f4c35ebe 11822-0056 HUMAN OTC DRUG nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140619 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 11822-0059_10048f16-957f-439c-8654-3d2c73ae3915 11822-0059 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20160715 ANDA ANDA091354 Rite Aid Corporation NICOTINE 4 mg/1 N 20181231 11822-0065_712aa963-f058-4b0a-adee-8124ca6c3344 11822-0065 HUMAN OTC DRUG nasal Oxymetazoline HCl SPRAY NASAL 19961205 OTC MONOGRAPH FINAL part341 Rite Aid Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 11822-0072_848d786b-8386-4855-8b10-7171514b8f08 11822-0072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 19970801 OTC MONOGRAPH NOT FINAL part348 Rite Aid EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 11822-0073_951d592d-9c3c-43b8-ae5a-247dcd58e072 11822-0073 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140625 OTC MONOGRAPH FINAL part333B Rite Aid Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 11822-0081_0a9bbc5a-bc61-439e-b7ea-35247478e10c 11822-0081 HUMAN OTC DRUG ZINC OXIDE ZINC OXIDE OINTMENT TOPICAL 20090519 OTC MONOGRAPH FINAL part347 RiteAid ZINC OXIDE 200 mg/g E 20171231 11822-0086_d3294a07-f5e6-4d77-9b90-a682265fb609 11822-0086 HUMAN OTC DRUG tussin severe multi symptom cough cold plus flu CF MAX Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20170922 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 11822-0091_1cdef16e-1a2c-42a9-a4b9-2659da1129e5 11822-0091 HUMAN OTC DRUG Complete Beauty octinoxate, zinc oxide LOTION TOPICAL 20100313 OTC MONOGRAPH FINAL part352 Rite Aid OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 11822-0096_4c4e9d67-41fc-48ff-8b4f-62a1410ee1ec 11822-0096 HUMAN OTC DRUG severe cold cough and flu relief daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20150805 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 11822-0098_3687f442-6f1b-4144-996b-fff76dd17230 11822-0098 HUMAN OTC DRUG Childrens Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Rite Aid Corporation LORATADINE 5 mg/5mL N 20181231 11822-0100_d8ad2c92-6a35-4e44-8f52-4de8212d1421 11822-0100 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM Sugar Free Robitussin Sugar Free Cough LIQUID ORAL 20131115 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 11822-0101_13993e38-311e-4f1d-a418-d1129208afb8 11822-0101 HUMAN OTC DRUG Multi-Symptom Cold and Cough Daytime Nighttime Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl KIT 20070222 20190415 OTC MONOGRAPH FINAL part341 Rite Aid Corporation N 20181231 11822-0102_26182c3b-af36-069c-e054-00144ff88e88 11822-0102 HUMAN OTC DRUG Renewal Hand Sanitizing Wipes Hand Sanitizing Wipes SWAB TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A rite aid corporation ALCOHOL .659 mL/mL N 20181231 11822-0104_8bec32ba-e24c-4522-87cb-94eb75e334c2 11822-0104 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 325 mg/1 N 20181231 11822-0107_4e72a6f4-1eda-4b64-9534-c24d20bd7409 11822-0107 HUMAN OTC DRUG childrens fever reducer and pain reliever Acetaminophen SUSPENSION ORAL 19970226 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 11822-0110_13854444-3746-4001-9151-f31fa01b3197 11822-0110 HUMAN OTC DRUG Peptic Relief BISMUTH SUBSALICYLATE SUSPENSION ORAL 20091016 OTC MONOGRAPH FINAL part335 Rite Aid Corporation BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 11822-0110_5d51db5f-a744-4e2c-af65-0d096061f9e1 11822-0110 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part335 Rite Aid Corporation BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 11822-0111_f9dc0488-594b-4b1e-8b35-35fdf0a47b79 11822-0111 HUMAN OTC DRUG Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20160730 OTC MONOGRAPH FINAL part331 Rite Aid Corporation CALCIUM CARBONATE 1000 mg/1 N 20181231 11822-0112_ca3aaf3d-4bf2-402d-9863-e39c76d6e155 11822-0112 HUMAN OTC DRUG Sinus Pressure and Congestion Relief Maximum Strength Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 Rite Aid Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 11822-0117_6bc0276e-4db5-422f-903e-ee218dc1c17e 11822-0117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 Rite Aid Corporation LANSOPRAZOLE 15 mg/1 N 20181231 11822-0118_6a3b26e6-d110-42f8-9a8f-f8c2f57689a6 11822-0118 HUMAN OTC DRUG Undecylenic Acid Antifungal Solution LIQUID TOPICAL 20171222 OTC MONOGRAPH FINAL part333C Rite Aid Corporation UNDECYLENIC ACID 7.5 g/30g N 20181231 11822-0119_2eb72136-c537-46d7-9559-3ada12773c58 11822-0119 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20171222 OTC MONOGRAPH FINAL part358F RITE AID CORPORATION SALICYLIC ACID .17 g/9mL N 20181231 11822-0120_f98b637c-d4c4-4ea7-be69-8bfe8c318147 11822-0120 HUMAN OTC DRUG Salicylic Acid Corn and Callus Remover Liquid LIQUID TOPICAL 20171222 OTC MONOGRAPH FINAL part358F Rite Aid Corporation SALICYLIC ACID .17 mg/9.8mL N 20181231 11822-0121_1b2b69fa-4e1a-4385-b4bb-33a3893692cb 11822-0121 HUMAN OTC DRUG Salicylic Acid Wart Remover Gel GEL TOPICAL 20141007 OTC MONOGRAPH FINAL part358B Rite Aid Corporation SALICYLIC ACID .17 g/7g N 20181231 11822-0122_84aa9f58-4182-432f-b8dd-e002e8a0a72a 11822-0122 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20171222 OTC MONOGRAPH FINAL part333C Rite Aid Corporation MICONAZOLE NITRATE 2.6 g/130g N 20181231 11822-0123_22fcdda0-afd8-428f-b901-67e7a4b9b65d 11822-0123 HUMAN OTC DRUG Salicylic Acid Ultra Thin Corn Removers PATCH TOPICAL 20171222 OTC MONOGRAPH FINAL part358F Rite Aid Corporation SALICYLIC ACID 40 mg/181 N 20181231 11822-0124_611181bf-fb54-40ef-ba5d-493658395964 11822-0124 HUMAN OTC DRUG nicotine Nicotine Polacrilex LOZENGE ORAL 20150205 ANDA ANDA090711 Rite Aid Corporation NICOTINE 2 mg/1 N 20181231 11822-0125_6bff0138-bbe4-4da3-a694-a1a561ebd2d3 11822-0125 HUMAN OTC DRUG Salicylic acid Medicated Callus Removers Extra Thick PATCH TOPICAL 20171222 OTC MONOGRAPH FINAL part358F Rite Aid Corporation SALICYLIC ACID 40 mg/41 N 20181231 11822-0126_db1d777d-c879-41fb-a272-0f6dbb68c290 11822-0126 HUMAN OTC DRUG Tussin CF Robitussin CF LIQUID ORAL 20131113 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 11822-0127_fe0939c9-8db1-489b-82a1-92845b634c9b 11822-0127 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20171222 OTC MONOGRAPH FINAL part358F Rite Aid Corporation SALICYLIC ACID 40 mg/91 N 20181231 11822-0128_4c7bc3f1-8b70-4261-adb3-6312c3612b00 11822-0128 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20171222 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/9mL; mg/9mL N 20181231 11822-0129_8f884879-af79-4b1c-a926-abda84e0467f 11822-0129 HUMAN OTC DRUG Minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20170309 ANDA ANDA091344 Rite Aid Corporation MINOXIDIL 50 mg/g N 20181231 11822-0131_3746c3ab-4c89-4b0d-bfc0-7227e0390dfc 11822-0131 HUMAN OTC DRUG ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170616 ANDA ANDA203599 Rite Aid Corporation IBUPROFEN 200 mg/1 N 20181231 11822-0132_f01cc802-6f7d-40dd-ba5e-c5883c388a05 11822-0132 HUMAN OTC DRUG Salicylic Acid Ultra Thin Corn Removers PATCH TOPICAL 20171222 OTC MONOGRAPH FINAL part358F Rite Aid Corporation SALICYLIC ACID 40 mg/91 N 20181231 11822-0133_9d78ebed-71c4-4e75-877b-b574f9d0dbf2 11822-0133 HUMAN OTC DRUG Salicylic Acid One Step Corn Remover PATCH TOPICAL 20171222 OTC MONOGRAPH FINAL part358F Rite Aid Corporation SALICYLIC ACID 40 mg/61 N 20181231 11822-0134_71f5e2b0-ceb0-4157-ba1f-ec30481aa32a 11822-0134 HUMAN OTC DRUG Salicylic acid Wart Remover PLASTER TOPICAL 20171222 OTC MONOGRAPH FINAL part358B Rite Aid Corporation SALICYLIC ACID .4 g/181 N 20181231 11822-0135_e0454118-908a-4811-9adb-e9423a9a453b 11822-0135 HUMAN OTC DRUG Miconazole Nitrate Athletes Foot Powder Spray Talc Free AEROSOL, POWDER TOPICAL 20171222 OTC MONOGRAPH FINAL part333C Rite Aid Corporation MICONAZOLE NITRATE 2.6 g/130g N 20181231 11822-0137_e91f75a9-231c-4a17-abf2-7b12bff69fe1 11822-0137 HUMAN OTC DRUG Gas Relief Regular Strength Simethicone TABLET, CHEWABLE ORAL 19910318 OTC MONOGRAPH FINAL part332 Rite Aid Corporation DIMETHICONE 80 mg/1 N 20181231 11822-0140_c6ebc5e8-eb68-448c-b78c-1ab06c7fa87b 11822-0140 HUMAN OTC DRUG Naproxen Sodium Naproxen sodium TABLET, FILM COATED ORAL 20160701 ANDA ANDA074661 Rite Aid Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 11822-0141_92e51445-1347-45d1-abd2-3e02f4bcd411 11822-0141 HUMAN OTC DRUG acid reducer original strength Famotidine TABLET ORAL 20090910 ANDA ANDA075400 Rite Aid Corporation FAMOTIDINE 10 mg/1 N 20181231 11822-0144_9c9d0771-2cab-4780-a6ef-5e53231b5c56 11822-0144 HUMAN OTC DRUG mucus relief d Guaifenesin, pseudoephedrine hydrochloride TABLET ORAL 20151218 ANDA ANDA091071 Rite Aid Corporation GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 11822-0148_16f7fbee-a0b6-4607-b206-78dae2cc838d 11822-0148 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen Acetaminophen TABLET ORAL 19930121 20180708 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN 500 mg/1 E 20171231 11822-0154_9737ebee-1147-46b1-9475-db24c7db9887 11822-0154 HUMAN OTC DRUG antifungal foot care tolnaftate SPRAY TOPICAL 20040924 OTC MONOGRAPH FINAL part333C Rite Aid Corporation TOLNAFTATE 1 g/100g N 20181231 11822-0157_49bba1aa-9664-4266-8fa8-e49be1b966c0 11822-0157 HUMAN OTC DRUG Pain Relief Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ASPIRIN 325 mg/1 N 20181231 11822-0161_a0b6abcc-54ca-4566-892b-4d4709b33bf7 11822-0161 HUMAN OTC DRUG fever reducer and pain reliever Acetaminophen SUSPENSION ORAL 20111207 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 11822-0166_9bb8e2bf-4c38-487f-a7bb-710b9030be32 11822-0166 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20020510 ANDA ANDA074937 Rite Aid Corporation IBUPROFEN 100 mg/5mL N 20181231 11822-0170_b83918cd-3169-4100-8be0-8d537e806f6e 11822-0170 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20160720 ANDA ANDA076789 Rite Aid Corporation NICOTINE 4 mg/1 N 20181231 11822-0173_d4ab418e-c783-40b0-98dd-d6d2c89b20ca 11822-0173 HUMAN OTC DRUG lice Piperonyl Butoxide, Pyrethrum Extract KIT 20071003 OTC MONOGRAPH FINAL part358G Rite Aid Corporation N 20181231 11822-0179_f7d681ba-db94-4c0f-92ff-8a03953f75b3 11822-0179 HUMAN OTC DRUG First Aid Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate OINTMENT TOPICAL 20060616 20180331 OTC MONOGRAPH FINAL part333B Rite Aid BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 11822-0180_adac1eee-9311-4869-8c8f-7334f5ac7105 11822-0180 HUMAN OTC DRUG Healing for Babies Petrolatum OINTMENT TOPICAL 20110520 OTC MONOGRAPH FINAL part347 Rite Aid PETROLATUM 41 kg/100kg N 20181231 11822-0186_931d4f33-365a-4787-8693-ccef0d031bdb 11822-0186 HUMAN OTC DRUG sleep aid Diphenhydramine HCl SOLUTION ORAL 20160707 OTC MONOGRAPH FINAL part338 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 11822-0188_12f226f8-73d3-48eb-96ac-4a10e26c7e7f 11822-0188 HUMAN OTC DRUG hemorrhoidal relief mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140320 OTC MONOGRAPH FINAL part346 Rite Aid Corporation MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 11822-0189_7dce152c-c3e8-4873-8e29-74234dbb4c7a 11822-0189 HUMAN OTC DRUG sleep aid diphenhydramine HCl TABLET ORAL 19900410 OTC MONOGRAPH FINAL part338 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 11822-0190_f9b22256-5527-4eac-8401-f4d62c6d51bf 11822-0190 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 11822-0194_6c84d923-0ff0-431d-873c-f6188734db24 11822-0194 HUMAN OTC DRUG acid reducer maximum strength Famotidine TABLET ORAL 20060929 ANDA ANDA077351 Rite Aid Corporation FAMOTIDINE 20 mg/1 N 20181231 11822-0198_f8686455-73f4-4ddf-8bbb-e5df1192358e 11822-0198 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Rite Aid Corporation DIMENHYDRINATE 50 mg/1 N 20181231 11822-0199_8901f8ed-8960-4ecd-98ef-26407af9b4a2 11822-0199 HUMAN OTC DRUG miconazole 1 feminine care Miconazole nitrate KIT 20100609 ANDA ANDA079114 Rite Aid Corporation N 20181231 11822-0200_abdde7e6-5eb1-4d25-b4c8-6c5dc4b32b42 11822-0200 HUMAN OTC DRUG Childrens Fever Reducer and Pain Reliever Acetaminophen SUSPENSION ORAL 19960105 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 11822-0202_234e7372-d350-4518-ab12-5ae512d83f4e 11822-0202 HUMAN OTC DRUG Minoxidil minoxidil SOLUTION TOPICAL 20161014 ANDA ANDA075357 Rite Aid Corporation MINOXIDIL 2 g/100mL N 20181231 11822-0207_01d8c276-9c81-4e58-a563-f0416935708a 11822-0207 HUMAN OTC DRUG anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19960612 UNAPPROVED DRUG OTHER Rite Aid Corporation DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 11822-0213_a29ff817-298f-42a8-9757-9c25e33d2a59 11822-0213 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20050225 OTC MONOGRAPH FINAL part355 Rite Aid SODIUM FLUORIDE .05 kg/100L N 20181231 11822-0217_ae227165-9ef4-4d45-b062-5ad7b57a1618 11822-0217 HUMAN OTC DRUG acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130921 ANDA ANDA075077 Rite Aid Corporation ACETAMINOPHEN 650 mg/1 N 20181231 11822-0219_f9f0de68-e1d6-4823-9e5d-e1e868f0fcf5 11822-0219 HUMAN OTC DRUG Clear Anti-Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 19971016 OTC MONOGRAPH NOT FINAL part347 Rite Aid PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 11822-0220_b3a4be72-7967-4a54-b21f-90cfbc6ba581 11822-0220 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 19961122 ANDA ANDA074165 Rite Aid CLOTRIMAZOLE 10 mg/g N 20181231 11822-0226_d3281a6c-88b6-4359-964f-5f51d67c6aaf 11822-0226 HUMAN OTC DRUG Stay Alert Aid Caffeine TABLET ORAL 19921121 20181111 OTC MONOGRAPH FINAL part340 Rite Aid CAFFEINE 200 mg/1 E 20171231 11822-0250_4135e2f1-2c9c-40f9-8455-c6241bb5cddd 11822-0250 HUMAN OTC DRUG Rite Aid Fungal UNDECYLENIC ACID LIQUID TOPICAL 20080601 OTC MONOGRAPH FINAL part333C Rite Aid Corporation UNDECYLENIC ACID 288 mg/mL E 20171231 11822-0279_28b1093f-5138-4a7a-a0b7-4c3810cc447b 11822-0279 HUMAN OTC DRUG Rite Aid Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 11822-0291_8be7eaa7-caee-4173-83b1-cb2ae63bc0ed 11822-0291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Rite Aid Corporation IBUPROFEN 200 mg/1 N 20181231 11822-0292_3ef37188-eb0b-4cff-b1c8-d7e6c06c1862 11822-0292 HUMAN OTC DRUG Pain Relief Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 Rite Aid Corporation IBUPROFEN 200 mg/1 N 20181231 11822-0294_c1d2b7be-0bc1-4308-ae8d-817dcb3787c2 11822-0294 HUMAN OTC DRUG renewal for men Minoxidil AEROSOL, FOAM TOPICAL 20120314 ANDA ANDA091344 Rite Aid Corporation MINOXIDIL 5 g/100g N 20181231 11822-0296_b21876e7-1037-4b8d-982f-4b90aa4725a2 11822-0296 HUMAN OTC DRUG Multi Symptom Cold CF dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20131206 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 11822-0299_b11219a4-324f-466a-b8a6-211071ae1a5e 11822-0299 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20010913 20180727 OTC MONOGRAPH FINAL part336 Rite Aid DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 11822-0300_617d06a0-ed3f-47d8-8af3-79d5a19d78e9 11822-0300 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090918 OTC MONOGRAPH NOT FINAL part356 Rite Aid Corporation HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 11822-0304_e8aeb43a-b14f-43be-9a19-60420ab15f9a 11822-0304 HUMAN OTC DRUG nasal oxymetazoline hydrochloride SPRAY NASAL 20131219 OTC MONOGRAPH FINAL part341 Rite Aid Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 11822-0306_c643fb56-e482-4fa3-8716-d6a7fe28f66f 11822-0306 HUMAN OTC DRUG Laxative Polyethylene Glycol 3350 POWDER ORAL 20091009 ANDA ANDA090685 Rite Aid Corporation POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 11822-0308_b6be6977-db88-459a-a9c0-7f3600b211bc 11822-0308 HUMAN OTC DRUG daytime cold relief multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20071022 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 11822-0309_223e52de-d38d-489a-95f1-a186a4a33877 11822-0309 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170124 ANDA ANDA206393 Rite Aid Corporation NICOTINE 4 mg/1 N 20181231 11822-0316_5b5627f3-7187-4c61-968f-227945897c01 11822-0316 HUMAN OTC DRUG Rite Aid Maximum Strength Benzocaine GEL, DENTIFRICE ORAL 20110120 OTC MONOGRAPH FINAL part333B Rite Aid BENZOCAINE 20 g/100g N 20181231 11822-0317_4f5c75b0-7562-4dda-8418-418587c843a6 11822-0317 HUMAN OTC DRUG Rite Aid Maximum Strength Benzocaine GEL, DENTIFRICE ORAL 20110120 OTC MONOGRAPH NOT FINAL part333A Rite Aid BENZOCAINE; BENZALKONIUM CHLORIDE; ZINC CHLORIDE 20; .04; .1 g/100g; g/100g; g/100g N 20181231 11822-0319_ed47c675-0876-4617-94e2-9b533ca7e097 11822-0319 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate TABLET, CHEWABLE ORAL 19980716 OTC MONOGRAPH FINAL part335 Rite Aid Corporation BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 11822-0321_93d2f86e-948a-4d71-8c0f-379ae1ad4955 11822-0321 HUMAN OTC DRUG acid reducer complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20090515 ANDA ANDA077355 Rite Aid Corporation FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 11822-0323_d4e6092e-d0ea-4674-b92c-66d426a8c9b2 11822-0323 HUMAN OTC DRUG Lubricant Eye Plus carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20130916 OTC MONOGRAPH FINAL part349 Rite Aid Corporation CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM .5 g/100mL N 20181231 11822-0325_89a796b6-ec3c-4428-8541-f53ebc5aabc2 11822-0325 HUMAN OTC DRUG mucus relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160706 ANDA ANDA091009 Rite Aid Corporation GUAIFENESIN 1200 mg/1 N 20181231 11822-0326_7a3c8a71-17e9-4078-b49c-78d711f08fc2 11822-0326 HUMAN OTC DRUG Laxative for Women Bisacodyl TABLET, COATED ORAL 20050212 20181111 OTC MONOGRAPH NOT FINAL part334 Rite Aid BISACODYL 5 mg/1 E 20171231 11822-0327_cd5442b9-9067-43df-89c1-8bc9abf8084d 11822-0327 HUMAN OTC DRUG Laxative Bisacodyl TABLET, SUGAR COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Rite Aid Corporation BISACODYL 5 mg/1 N 20181231 11822-0328_911bcb7f-e974-4308-ae44-146c35b3b551 11822-0328 HUMAN OTC DRUG daytime nighttime severe cold and flu relief Acetaminophen, dextromethorphan HBr, Doxylamine Succinate, Guaifenesin, Phenylephrine HCl KIT 20150724 OTC MONOGRAPH FINAL part341 Rite Aid Corporation N 20181231 11822-0329_ebffee43-1b30-49dd-a5e6-175f84337453 11822-0329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, FILM COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 11822-0334_c01e2bb7-b359-47a0-b7e8-90220cd3c6dc 11822-0334 HUMAN OTC DRUG pain reliever extra strength acetaminophen, aspirin, caffeine TABLET, FILM COATED ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 11822-0335_c73f24da-626b-49f5-b30c-670dee23925e 11822-0335 HUMAN OTC DRUG nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20120907 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 11822-0337_893e5882-454c-4c93-8f82-8f3bf72e3981 11822-0337 HUMAN OTC DRUG stomach relief Bismuth subsalicylate SUSPENSION ORAL 20120711 OTC MONOGRAPH FINAL part335 Rite Aid Corporation BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 11822-0338_222c292d-580a-4ca7-a756-fab1dcdc24af 11822-0338 HUMAN OTC DRUG Backache Relief Magnesium Salicylate Tetrahydrate TABLET, FILM COATED ORAL 19981107 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation MAGNESIUM SALICYLATE 580 mg/1 N 20181231 11822-0340_bee8a0c3-4cc2-4108-883c-5d8403e60377 11822-0340 HUMAN OTC DRUG Arthritis Creme Trolamine Salicylate CREAM TOPICAL 20050723 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation TROLAMINE SALICYLATE 10 g/100g N 20181231 11822-0342_fa2f28f8-85c7-4ddc-be6c-259bd5d8a13d 11822-0342 HUMAN OTC DRUG tussin mucus and chest congestion Guaifenesin SYRUP ORAL 20140729 OTC MONOGRAPH FINAL part341 Rite Aid Corporation GUAIFENESIN 200 mg/10mL N 20181231 11822-0344_239ed168-6ca5-4d23-bf6e-f1e2bff161ae 11822-0344 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20060224 ANDA ANDA077007 Rite Aid Corporation NICOTINE 2 mg/1 N 20181231 11822-0345_84d41161-080a-419d-97c6-02c785829adb 11822-0345 HUMAN OTC DRUG Rite Aid Maximum Strength Benzocaine LIQUID DENTAL 20150101 OTC MONOGRAPH FINAL part333B Rite Aid BENZOCAINE 20 g/100g N 20181231 11822-0346_e3bc543f-616e-410c-8a0d-25004d15366e 11822-0346 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate TABLET ORAL 20110506 OTC MONOGRAPH FINAL part335 Rite Aid Corporation BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 11822-0348_fea1ad8f-cf9f-4145-a8eb-67ca0bd49b29 11822-0348 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET, SUGAR COATED ORAL 20030102 OTC MONOGRAPH NOT FINAL part334 Rite Aid Corporation SENNOSIDES 25 mg/1 N 20181231 11822-0350_a93eb7a1-fcce-4074-aeaf-ecc2d679f6d1 11822-0350 HUMAN OTC DRUG Foot Care Clotrimazole Clotrimazole CREAM TOPICAL 20100312 OTC MONOGRAPH FINAL part333C Rite Aid CLOTRIMAZOLE 10 mg/g N 20181231 11822-0351_c2f2c3c2-c2c4-43b9-9e97-5f143dcce7fd 11822-0351 HUMAN OTC DRUG Antifungal Clotrimazole CREAM TOPICAL 20110415 OTC MONOGRAPH FINAL part333C Rite Aid CLOTRIMAZOLE 10 mg/g N 20181231 11822-0352_026477f2-4e3c-475b-baad-04e7916d3413 11822-0352 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20161007 ANDA ANDA078547 Rite Aid Corporation NICOTINE 2 mg/1 N 20181231 11822-0359_a4c8fbcb-8c03-4ccc-9a6f-ab6166fc1a03 11822-0359 HUMAN OTC DRUG Cough and Chest Congestion DM Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20130921 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 11822-0365_5e25d722-7c79-45e0-90e8-35548fc0ac99 11822-0365 HUMAN OTC DRUG nicotine gum Nicotine Polacrilex GUM, CHEWING ORAL 20160730 ANDA ANDA091349 Rite Aid Corporation NICOTINE 2 mg/1 N 20181231 11822-0368_998a8214-1def-4e35-8339-c631d604dedf 11822-0368 HUMAN OTC DRUG naproxen sodium all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20010516 ANDA ANDA074661 Rite Aid Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 11822-0370_0c4c3c31-edac-4338-92e8-c01a49a2dd46 11822-0370 HUMAN OTC DRUG Rite Aid Maximum Strength Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE GEL TOPICAL 20110810 OTC MONOGRAPH FINAL part336 RITE AID CORPORATION DIPHENHYDRAMINE HYDROCHLORIDE 20.5 mg/mL E 20171231 11822-0371_e1af9632-965f-49a2-9412-deb6e16bd31f 11822-0371 HUMAN OTC DRUG Rite Aid Maximum Strength Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE SPRAY TOPICAL 20110810 OTC MONOGRAPH FINAL part336 RITE AID CORPORATION DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/mL; mg/mL E 20171231 11822-0373_f347c2bf-72b7-4e89-8697-3260886504af 11822-0373 HUMAN OTC DRUG PM pain reliever Acetaminophen and Diphenhydramine Citrate TABLET, FILM COATED ORAL 20040607 20200220 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 N 20181231 11822-0374_9fb84729-2e48-4712-88b4-25b14f0b2cc5 11822-0374 HUMAN OTC DRUG migraine relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20020514 ANDA ANDA075794 Rite Aid Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 11822-0375_447399b2-27e4-4104-9d1b-2ab41ed11731 11822-0375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 Rite Aid Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 11822-0376_c25863db-babb-4b5a-9df5-24c96a7c6a71 11822-0376 HUMAN OTC DRUG Rite Aid Diaper Rash ZINC OXIDE OINTMENT TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part352 RiteAid Corporation ZINC OXIDE 400 mg/g N 20181231 11822-0378_6a04b548-180e-409e-a8c0-6c2f5038fc0b 11822-0378 HUMAN OTC DRUG Advanced Firming and Anti Wrinkle Ensulizole, Octinoxate CREAM TOPICAL 20100210 OTC MONOGRAPH NOT FINAL part352 Rite Aid Corporation OCTINOXATE; ENSULIZOLE 7.5; 2 g/100g; g/100g N 20181231 11822-0384_74f052f2-2216-41e9-805a-d291a035b59d 11822-0384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120827 ANDA ANDA091135 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 11822-0386_e062dc2c-251c-4d09-af79-0ba8571cadab 11822-0386 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 Rite Aid Corporation DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 11822-0390_8af747cb-e6d2-4442-ab8b-e11464ebf70e 11822-0390 HUMAN OTC DRUG Menstrual Complete Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 11822-0391_bf7ec4ef-e6ac-4e6a-a932-e30697a50782 11822-0391 HUMAN OTC DRUG Maximum Strength Menstrual Complete Acetaminophen, Caffeine, Pyrilamine maleate CAPSULE, LIQUID FILLED ORAL 20010614 20181111 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 E 20171231 11822-0392_441ca399-b0b8-4d78-bc7f-57a7fb66cb01 11822-0392 HUMAN OTC DRUG pain relief ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020330 ANDA ANDA075139 Rite Aid Corporation IBUPROFEN 200 mg/1 N 20181231 11822-0393_6d11e72f-1859-45ae-a3b7-085d353205e0 11822-0393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Rite Aid Corporation IBUPROFEN 200 mg/1 N 20181231 11822-0397_2c6df4bb-b41b-4174-ae44-af99a1cc3178 11822-0397 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, CHEWABLE ORAL 20010904 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ASPIRIN 81 mg/1 N 20181231 11822-0399_60284706-4460-f795-e053-2a91aa0a0a12 11822-0399 HUMAN OTC DRUG MILK OF MAGNESIA CHERRY magnesium hydroxide LIQUID ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 RITE AID PHARMACY MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 11822-0401_43a83ce0-048f-4460-a07b-e34172a1999b 11822-0401 HUMAN OTC DRUG nausea relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20141104 UNAPPROVED DRUG OTHER Rite Aid Corporation DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 11822-0403_9bf2a966-c99f-459b-a43b-44e75af6ca95 11822-0403 HUMAN OTC DRUG Night Time Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20091016 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 11822-0404_e92e494e-2264-4f8a-9cad-056b9d16c270 11822-0404 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET, CHEWABLE ORAL 20020529 OTC MONOGRAPH FINAL part336 Rite Aid Corporation MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 11822-0405_39d50907-350c-4068-b4cd-a1d55522fad8 11822-0405 HUMAN OTC DRUG CVS Fragrance Free Anti-Itch PRAMOXINE HYDROCHLORIDE LOTION TOPICAL 20100708 OTC MONOGRAPH NOT FINAL part348 RITE AID CORPORATION PRAMOXINE HYDROCHLORIDE 10 mg/mL E 20171231 11822-0406_7dfafb22-9a79-4cbb-ad09-266755325927 11822-0406 HUMAN OTC DRUG Rite Aid Ultra Strength Muscle Rub MENTHOL, CAMPHOR, AND METHYLSALICYLATE OINTMENT TOPICAL 20110328 OTC MONOGRAPH NOT FINAL part348 RITE AID CORPORATION MENTHOL; CAMPHOR (SYNTHETIC); METHYL SALICYLATE 100; 40; 300 mg/g; mg/g; mg/g E 20171231 11822-0407_a8cb6669-b661-47b2-a7cf-92603354674b 11822-0407 HUMAN OTC DRUG RITEAID HEMORRHOIDAL COOLING WITCH HAZEL, PHENYLEPHRINE HYDROCHLORIDE GEL TOPICAL 20101118 OTC MONOGRAPH FINAL part346 Rite Aid Corporation WITCH HAZEL; PHENYLEPHRINE HYDROCHLORIDE 500; 2.5 mg/g; mg/g E 20171231 11822-0413_3626faa8-e9bc-4a05-b41a-23c4453ac7d9 11822-0413 HUMAN OTC DRUG Tussin Original Guaifenesin LIQUID ORAL 20090716 OTC MONOGRAPH FINAL part341 Rite Aid Corporation GUAIFENESIN 100 mg/5mL N 20181231 11822-0413_c0849511-4784-4f27-8acf-b0ccbfa6f1a1 11822-0413 HUMAN OTC DRUG Tussin Original GUAIFENESIN LIQUID ORAL 20090811 OTC MONOGRAPH FINAL part341 Rite Aid Corporation GUAIFENESIN 100 mg/5mL N 20181231 11822-0414_5c1d24c3-19e0-45ae-b4ec-a1d9d995dc83 11822-0414 HUMAN OTC DRUG Rite Aid Acne Pads, Daily Cleansing Pads SALICYLIC ACID SWAB TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333D Right Aid Corporation SALICYLIC ACID 21 mg/1 E 20171231 11822-0415_6d2e677c-06bd-4d3f-b171-e970ed2a7c90 11822-0415 HUMAN OTC DRUG Rite Aid Soothing Medicated Anit-Itch MENTHOL, PRAMOXINE HYDROCHLORIDE CREAM TOPICAL 20100708 OTC MONOGRAPH FINAL part347 RITE AID CORPORATION PRAMOXINE HYDROCHLORIDE; MENTHOL 10; 10 mg/g; mg/g E 20171231 11822-0416_b86ae8c6-c6dc-42d7-baca-26ea698103d7 11822-0416 HUMAN OTC DRUG Intensive Healing Anti Itch Hydrocortisone CREAM TOPICAL 20140320 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation HYDROCORTISONE 1 g/100g N 20181231 11822-0419_68195bbf-4698-46ec-920f-63f33c3d7ae5 11822-0419 HUMAN OTC DRUG Cough childrens mucus relief Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20070816 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 11822-0426_8709b2d9-05a0-4999-850e-cf7c27b7d09e 11822-0426 HUMAN OTC DRUG tioconazole 1 1 dose treatment Tioconazole OINTMENT VAGINAL 20071213 ANDA ANDA075915 Rite Aid Corporation TIOCONAZOLE 6.5 g/100g N 20181231 11822-0428_33e6f062-60a2-4007-984b-b43a8cbba365 11822-0428 HUMAN OTC DRUG Tension Headache Aspirin-Free Acetaminophen, Caffeine TABLET, FILM COATED ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 11822-0434_d0393b29-db4b-4883-8b0e-17a01bdfeeb3 11822-0434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 Rite Aid EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11822-0440_cdaa9a48-0268-4985-b776-3bf46dd2bf32 11822-0440 HUMAN OTC DRUG Hand Sanitizer Ethyl alcohol GEL TOPICAL 20100712 OTC MONOGRAPH NOT FINAL part333A Rite Aid ALCOHOL 585 mg/mL N 20181231 11822-0442_4582715c-c8d8-4847-b833-6b42e561def4 11822-0442 HUMAN OTC DRUG Long Acting Tussin Cough Gels Dextromethorphan HBr CAPSULE, GELATIN COATED ORAL 20060424 20180827 OTC MONOGRAPH FINAL part341 Rite Aid DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 E 20171231 11822-0443_b4136b1f-0618-42f0-a9e6-28a1852a909a 11822-0443 HUMAN OTC DRUG Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20170615 ANDA ANDA078104 Rite Aid Corporation TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 11822-0444_cd82bf3a-200d-4b94-83f5-699e895fa568 11822-0444 HUMAN OTC DRUG antibiotic and pain relief Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20050817 OTC MONOGRAPH FINAL part333B Rite Aid Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 11822-0447_e17c7d6d-286c-4c96-bbb2-623a5c2a6704 11822-0447 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050203 20200606 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 80 mg/1 N 20181231 11822-0449_cc0b9e14-115a-4430-ae5d-dba867b4924d 11822-0449 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050128 20200606 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/1 N 20181231 11822-0450_11bc7139-9e7a-4ca0-89f8-6f8c662b2c52 11822-0450 HUMAN OTC DRUG HEMORRHOID RELIEF COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20110701 OTC MONOGRAPH FINAL part346 Rite Aid Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE .855; .0025 g/g; g/g E 20171231 11822-0452_258a833d-eec0-4dab-979e-60196ac0c21e 11822-0452 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20041206 20190708 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 80 mg/1 E 20171231 11822-0453_824fe5e8-ef43-4a4a-868c-7928b1f22860 11822-0453 HUMAN OTC DRUG omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150326 NDA NDA022032 Rite Aid Corporation OMEPRAZOLE 20 mg/1 N 20181231 11822-0456_ad059953-71b1-4001-842b-a264646d4ecc 11822-0456 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061026 ANDA ANDA076777 Rite Aid Corporation NICOTINE 2 mg/1 N 20181231 11822-0458_1b27615b-6dcb-4c8e-bd39-7abcec1cbc06 11822-0458 HUMAN OTC DRUG allergy relief Cetirizine Hydrochloride TABLET ORAL 20080116 ANDA ANDA078336 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 11822-0459_c229aab4-5e83-4382-8c91-de75f1914c3b 11822-0459 HUMAN OTC DRUG nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20120907 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 11822-0460_e1068e60-d849-4ada-9946-f21f1a8441ee 11822-0460 HUMAN OTC DRUG Cold and Flu Acetaminophen and Chlorpheniramine Maleate TABLET, COATED ORAL 20050531 20180604 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 325; 2 mg/1; mg/1 E 20171231 11822-0461_85b7790d-2e72-45a5-b70b-d9c2be31d039 11822-0461 HUMAN OTC DRUG Maximum Strength Flu Acetaminophen, Dextromethorphan HBr, Chlorpheniramine maleate TABLET, FILM COATED ORAL 20050601 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE 500; 15; 2 mg/1; mg/1; mg/1 N 20181231 11822-0462_29fb4a0d-fa55-4f87-983b-a246fe08c9f8 11822-0462 HUMAN OTC DRUG Sinus and Allergy Relief PE Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341 Rite Aid Corporation CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 11822-0466_612d1cc2-cee3-42f4-b1b8-c7041233c5ca 11822-0466 HUMAN OTC DRUG Daytime Congestion and Pain Sinus Relief Acetaminophen and Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 20180409 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 11822-0468_ef8049c0-0605-4a6d-8200-e4608017eadc 11822-0468 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160627 OTC MONOGRAPH FINAL part331 Rite Aid Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 11822-0471_deed7581-b8c5-4591-b383-4f01a2165027 11822-0471 HUMAN OTC DRUG anti itch hydrocortisone OINTMENT TOPICAL 20050725 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation HYDROCORTISONE 1 g/100g N 20181231 11822-0475_09474431-cf46-45da-8b20-9551ddea28a7 11822-0475 HUMAN OTC DRUG childrens allergy relief Cetirizine HCl SOLUTION ORAL 20160323 ANDA ANDA204226 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 11822-0478_ea492842-aa85-48ba-81d8-77d20e05b3a0 11822-0478 HUMAN OTC DRUG antacid calcium carbonate TABLET, CHEWABLE ORAL 20160730 OTC MONOGRAPH FINAL part331 Rite Aid Corporation CALCIUM CARBONATE 500 mg/1 N 20181231 11822-0485_4ba377d0-b7d8-4653-b3e7-8922fbe92b68 11822-0485 HUMAN OTC DRUG Allergy Plus Sinus Relief Diphenhydramine HCl and Phenylephrine HCl TABLET ORAL 20050810 20181111 OTC MONOGRAPH FINAL part341 Rite Aid DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 25; 10 mg/1; mg/1 E 20171231 11822-0489_cc40a98b-8b03-4228-80c1-f516c2a117eb 11822-0489 HUMAN OTC DRUG antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160720 OTC MONOGRAPH FINAL part331 Rite Aid Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 11822-0490_2132db7f-0233-4835-a12c-caea6e1d3825 11822-0490 HUMAN OTC DRUG naproxen sodium Naproxen Sodium TABLET ORAL 20010516 ANDA ANDA074661 Rite Aid Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 11822-0493_f6503794-e062-4be5-81cf-806a2735f4b9 11822-0493 HUMAN OTC DRUG Tussin Long Acting Cough Dextromethorphan Hydrobromide LIQUID ORAL 19970819 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL N 20181231 11822-0494_0b92c230-e86f-4e2f-9330-6a85de61eaf0 11822-0494 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150706 ANDA ANDA091135 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 11822-0497_6c9075f4-c38c-4c01-b800-0771e08bb664 11822-0497 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20110214 OTC MONOGRAPH FINAL part358H Rite Aid COAL TAR 1.02 mg/mL N 20181231 11822-0498_8e18bd43-773b-41c5-880d-d34cd0755d1c 11822-0498 HUMAN OTC DRUG mucus relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130320 ANDA ANDA078912 Rite Aid Corporation GUAIFENESIN 600 mg/1 N 20181231 11822-0499_b0c088b8-5dac-4784-8c3b-46978d01fb97 11822-0499 HUMAN OTC DRUG Anti Itch Hydrocortisone CREAM TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation HYDROCORTISONE 1 g/100g N 20181231 11822-0500_779883b0-cd4c-424a-b625-464cb135eebf 11822-0500 HUMAN OTC DRUG Acid Reducer Plus Antacid famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20131108 ANDA ANDA077355 Rite Aid Corporation FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 11822-0503_609c186b-573f-4b09-9cbf-c29a9407d755 11822-0503 HUMAN OTC DRUG head congestion and cold relief daytime Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, FILM COATED ORAL 20050804 20190126 OTC MONOGRAPH FINAL part341 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 11822-0507_388cea43-5410-4999-a364-e8d0241b904e 11822-0507 HUMAN OTC DRUG naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20010516 ANDA ANDA074661 Rite Aid Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 11822-0511_4bf8d17d-d937-4351-98f5-8d3322592c3d 11822-0511 HUMAN OTC DRUG nighttime severe cold and flu relief Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20150723 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 11822-0519_08bd4e42-212b-4973-b811-e3cb48b75952 11822-0519 HUMAN OTC DRUG pain relief acetaminophen Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 500 mg/1 N 20181231 11822-0521_5e526d19-631b-4fb6-b3e1-6e0a76b17226 11822-0521 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20100625 ANDA ANDA076359 Rite Aid Corporation IBUPROFEN 100 mg/1 N 20181231 11822-0523_e3836d31-d547-4568-9540-ff0dd25751f8 11822-0523 HUMAN OTC DRUG lice Piperonyl butoxide, pyrethrum extract KIT 20160511 OTC MONOGRAPH FINAL part358G Rite Aid Corporation N 20181231 11822-0527_ce63bab5-766a-4990-95c4-f74d5e840732 11822-0527 HUMAN OTC DRUG Sinus Congestion and Pain Relief Non-Drowsy/Daytime Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 11822-0528_6ae7a5d6-d4fa-47bf-8821-f984c3588b95 11822-0528 HUMAN OTC DRUG antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20160627 OTC MONOGRAPH FINAL part331 Rite Aid Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 11822-0532_da983e6f-5794-44c5-8bfb-2f6f5af4aeff 11822-0532 HUMAN OTC DRUG Mucus Relief Chest Congestion Guaifenesin TABLET, FILM COATED ORAL 20051222 OTC MONOGRAPH FINAL part341 Rite Aid Corporation GUAIFENESIN 400 mg/1 N 20181231 11822-0539_74bde4d5-0fc5-40cd-8818-d24f9f13455f 11822-0539 HUMAN OTC DRUG antifungal Tolnaftate SPRAY TOPICAL 20160512 OTC MONOGRAPH FINAL part333C Rite Aid Corporation TOLNAFTATE 1 g/100g N 20181231 11822-0542_4e188f73-f818-4492-abb1-27132981ebe6 11822-0542 HUMAN OTC DRUG Sinus Congestion PE Guaifenesin and Phenylephrine HCl TABLET ORAL 20060415 20190708 OTC MONOGRAPH FINAL part341 Rite Aid Corporation GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 E 20171231 11822-0543_6f953445-b89e-4b5d-88ae-b0b493b22048 11822-0543 HUMAN OTC DRUG Severe Allergy And Sinus Headache Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET ORAL 20070627 20190330 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 11822-0544_d255a9e8-83c2-4124-90f8-fbcc42bcd86d 11822-0544 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130930 ANDA ANDA075077 Rite Aid Corporation ACETAMINOPHEN 650 mg/1 N 20181231 11822-0546_2791134b-a073-4843-817a-e9e5d6a0c346 11822-0546 HUMAN OTC DRUG cold and cough sinus relief PE NON-DROWSY Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20070222 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 11822-0548_bab003f9-ba1b-4d0d-a19b-c17214c5a9ea 11822-0548 HUMAN OTC DRUG daytime severe cold and flu relief acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140709 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 11822-0549_fededd3d-42a5-4b86-af2f-0fa1a4601fc8 11822-0549 HUMAN OTC DRUG lice treatment Permethrin LOTION TOPICAL 20110126 ANDA ANDA076090 Rite Aid Corporation PERMETHRIN 1 mg/100mL N 20181231 11822-0551_70783ec8-cf65-480b-bdb5-0e7903368ab5 11822-0551 HUMAN OTC DRUG body Menthol, Zinc Oxide POWDER TOPICAL 20030905 OTC MONOGRAPH NOT FINAL part348 Rite Aid MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g N 20181231 11822-0552_b983229c-9927-4540-9da4-d1430bf21b78 11822-0552 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20150701 NDA NDA020065 Rite Aid Corporation NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL N 20181231 11822-0554_299dee64-65c9-43d8-89fd-7d1fd99f337b 11822-0554 HUMAN OTC DRUG HOME ANTIBACTERIAL Fresh Scent Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation BENZALKONIUM CHLORIDE .115 g/1 N 20181231 11822-0556_d3489f1b-ed6e-4a71-be99-12f7983ba75f 11822-0556 HUMAN OTC DRUG Acetaminophen PM Acetaminophen and Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 11822-0560_3226f242-3d3a-484c-8180-fb89799afc8c 11822-0560 HUMAN OTC DRUG Multi-Symptom Daytime Cold Acetaminophen, Phenylephrine HCl and Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20080329 20181110 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 11822-0566_80ca228c-0901-4c9f-ac37-e3a9bcb47a24 11822-0566 HUMAN OTC DRUG allergy and congestion relief d original prescription strength Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080410 ANDA ANDA077170 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 11822-0571_ec7cffaa-b4ce-4f57-9aca-aef352b2fd8e 11822-0571 HUMAN OTC DRUG allergy relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110415 ANDA ANDA076447 Rite Aid Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 11822-0578_abe9bf40-139a-4d0e-8216-686c027f50a9 11822-0578 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine HCl TABLET, CHEWABLE ORAL 20081031 ANDA ANDA078692 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 11822-0580_df2be495-799b-4a3b-bad3-b9b93f0e3ec0 11822-0580 HUMAN OTC DRUG Daytime Nighttime Cold and Flu Relief Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140613 OTC MONOGRAPH FINAL part341 Rite Aid Corporation N 20181231 11822-0588_8564beea-7535-45f7-8a3e-95aa91d18045 11822-0588 HUMAN OTC DRUG Sinus Congestion and Pain Relief Non-Drowsy, Daytime Acetaminophen and Phenylephrine HCl TABLET ORAL 20080317 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 11822-0590_9f5b6b10-7217-4f5b-86a4-c5d53f615d7a 11822-0590 HUMAN OTC DRUG infants fever reducer and pain reliever acetaminophen SUSPENSION ORAL 19930908 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 11822-0595_c2fb5988-a5f0-41ea-b530-b3c8b59767e4 11822-0595 HUMAN OTC DRUG childrens fever reducer and pain reliever Acetaminophen SUSPENSION ORAL 19970923 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 11822-0599_daf7a11f-9c81-4229-93f2-a32e824f7444 11822-0599 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine HCl TABLET, CHEWABLE ORAL 20110425 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20181231 11822-0600_44eb27e9-1c35-4572-b0d4-a298d4cb6ec7 11822-0600 HUMAN OTC DRUG Pain Relief Aspirin Low Dose Aspirin TABLET, COATED ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ASPIRIN 81 mg/1 N 20181231 11822-0603_0594fed4-c7e7-4a37-9cb7-98e0717c47e2 11822-0603 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090416 OTC MONOGRAPH NOT FINAL part334 Rite Aid Corporation MINERAL OIL 15 mL/15mL N 20181231 11822-0606_004d2158-273f-4f99-b342-e3add375be30 11822-0606 HUMAN OTC DRUG Daylogic For Men Minoxidil AEROSOL, FOAM TOPICAL 20160805 ANDA ANDA091344 Rite Aid Corporation MINOXIDIL 5 g/100g N 20181231 11822-0608_182d41a1-e65f-426c-bbee-373e477d3bd1 11822-0608 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone TABLET, CHEWABLE ORAL 20130701 OTC MONOGRAPH FINAL part332 Rite Aid Corporation DIMETHICONE 125 mg/1 N 20181231 11822-0612_06c31132-7a68-49f4-98bb-099855e213a4 11822-0612 HUMAN OTC DRUG allergy relief Loratadine TABLET ORAL 20041021 ANDA ANDA076301 Rite Aid Corporation LORATADINE 10 mg/1 N 20181231 11822-0617_5e6c48e8-fcaf-436c-a024-0fabebd21ca8 11822-0617 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cold Max Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 11822-0619_133f2a93-1cb6-42db-80be-7abf71569db9 11822-0619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20120423 OTC MONOGRAPH FINAL part347 Rite Aid Corporation DIMETHICONE 1.3 kg/100mL N 20181231 11822-0622_2e6a4b14-3428-4c29-981f-d36d0c893c74 11822-0622 HUMAN OTC DRUG anti itch and skin protectant Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20050730 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 11822-0631_ddeda65b-2d37-40fd-b422-0b7c065a3411 11822-0631 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170201 ANDA ANDA075077 Rite Aid Corporation ACETAMINOPHEN 650 mg/1 N 20181231 11822-0637_39f1366a-d16c-43fb-a4fc-32218b120b52 11822-0637 HUMAN OTC DRUG antibiotic plus pain relief maximum strength Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20050714 OTC MONOGRAPH FINAL part333B Rite Aid Corporation NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g N 20181231 11822-0645_5e0cd1ef-a90b-33c3-e053-2a91aa0a2209 11822-0645 HUMAN OTC DRUG Rite Aid Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 Rite Aid Corporation. CASTOR OIL 1 mg/mL N 20181231 11822-0650_447c9665-a15b-4eb7-a388-680c230616fe 11822-0650 HUMAN OTC DRUG sinus pressure and congestion relief maximum strength Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 19990830 ANDA ANDA075153 Rite Aid Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 11822-0656_6ed3ef31-114b-498d-bfed-840a2e19b9a3 11822-0656 HUMAN OTC DRUG daytime cold and flu relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20120907 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 11822-0660_000687f9-9921-4bf3-a6b6-45d3658507ff 11822-0660 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION ORAL 20020510 ANDA ANDA074937 Rite Aid Corporation IBUPROFEN 100 mg/5mL N 20181231 11822-0662_1dce11c3-ca2c-4223-a92b-f8306473d12a 11822-0662 HUMAN OTC DRUG allergy relief Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Rite Aid Corporation CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 11822-0664_06f91074-69ca-4e19-8f78-1809f75102a6 11822-0664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19950721 OTC MONOGRAPH NOT FINAL part356 Rite Aid EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11822-0667_616cdb9c-4bec-4e0a-8d65-83b0a0da8c20 11822-0667 HUMAN OTC DRUG Hair Regrowth Treatment for Women Minoxidil SOLUTION TOPICAL 20030101 20190630 ANDA ANDA074588 Rite Aid MINOXIDIL 2 g/100mL N 20181231 11822-0668_923a8114-4f1d-441a-9175-9337b1070087 11822-0668 HUMAN OTC DRUG nighttime cough relief Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20020807 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 11822-0669_5f0f5eb5-b8a7-4a61-b56e-5918c4db2e1a 11822-0669 HUMAN OTC DRUG Multi Symptom Cold CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20140724 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 11822-0672_1ed8c188-0db9-43c4-b8be-811c25480baa 11822-0672 HUMAN OTC DRUG sleep aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20150724 OTC MONOGRAPH FINAL part338 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 11822-0676_73f058c2-10d7-4881-8205-ea7c37209e57 11822-0676 HUMAN OTC DRUG laxative for women Bisacodyl TABLET, COATED ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 Rite Aid Corporation BISACODYL 5 mg/1 N 20181231 11822-0680_74af5a5c-5825-410e-aadd-8cc1b036e778 11822-0680 HUMAN OTC DRUG anti itch maximum strength plus hydrocortisone CREAM TOPICAL 20110216 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation HYDROCORTISONE 1 g/100g N 20181231 11822-0684_f399a188-ccc2-46c2-9994-75d183475c67 11822-0684 HUMAN OTC DRUG PETROLATUM and LANOLIN PETROLATUM and LANOLIN OINTMENT TOPICAL 20090519 OTC MONOGRAPH FINAL part347 RiteAid PETROLATUM; LANOLIN .534; .155 g/g; g/g E 20171231 11822-0686_1c7e311c-81f9-4c27-8043-b46cf39e16db 11822-0686 HUMAN OTC DRUG Laxative dye free Bisacodyl TABLET, SUGAR COATED ORAL 20160301 OTC MONOGRAPH NOT FINAL part334 Rite Aid Corporation BISACODYL 5 mg/1 N 20181231 11822-0691_64619a42-5360-46f6-9c8e-eda7ad1a722f 11822-0691 HUMAN OTC DRUG Stay Awake Caffeine TABLET, FILM COATED ORAL 19980414 OTC MONOGRAPH FINAL part340 Rite Aid Corporation CAFFEINE 200 mg/1 N 20181231 11822-0692_e2c9992d-60f8-4a77-b3fe-2d5ddf5993ce 11822-0692 HUMAN OTC DRUG cool heat Menthol, Methyl salicylate CREAM TOPICAL 20050726 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 11822-0695_065a5fa2-e9ce-4f5e-aa6d-62eaef9156f9 11822-0695 HUMAN OTC DRUG jock itch Tolnaftate SPRAY TOPICAL 20041012 OTC MONOGRAPH FINAL part333C Rite Aid Corporation TOLNAFTATE 1 g/100g N 20181231 11822-0699_f872b638-efcf-42d4-9f82-6390f5f47247 11822-0699 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20160728 ANDA ANDA076779 Rite Aid Corporation NICOTINE 4 mg/1 N 20181231 11822-0703_f93a5f69-f2d6-40f8-a8f5-1eedd9586182 11822-0703 HUMAN OTC DRUG first aid triple antibiotic pain and scar Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20170309 OTC MONOGRAPH FINAL part333B Rite Aid Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20191231 11822-0708_f003ab63-199a-423b-972a-cba8a2d0ad6c 11822-0708 HUMAN OTC DRUG Regular Strength Pain Relief Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ASPIRIN 325 mg/1 N 20181231 11822-0710_70e7eacf-21c6-405f-8c35-4be94a345aeb 11822-0710 HUMAN OTC DRUG Daytime Severe Cold and Flu Relief acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20140618 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 11822-0717_aa930ec9-3d37-4ef2-8488-63967370bf79 11822-0717 HUMAN OTC DRUG day severe cold night cold and flu Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, doxylamine succinate KIT 20170628 OTC MONOGRAPH FINAL part341 Rite Aid Corporation N 20181231 11822-0730_d1ee7ad8-fb01-4298-98a5-15787efdab77 11822-0730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20010301 ANDA ANDA074164 Rite Aid MICONAZOLE NITRATE 20 mg/g N 20181231 11822-0734_b941bfce-13df-4b70-b502-f23f1e17a5c7 11822-0734 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130119 ANDA ANDA203690 Rite Aid Corporation NICOTINE 2 mg/1 N 20181231 11822-0735_0a109ecf-80e0-4e13-b824-6aed756e319b 11822-0735 HUMAN OTC DRUG mucus relief DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160706 ANDA ANDA091070 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 11822-0737_a684a6d3-ddb5-42fb-9d5a-0812b3971684 11822-0737 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100609 ANDA ANDA079114 Rite Aid Corporation N 20181231 11822-0751_44f85d04-e248-44f1-b4f9-44e2bf4e7d60 11822-0751 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen, Aspirin, Caffeine CAPSULE, GELATIN COATED ORAL 20090109 20181111 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 E 20171231 11822-0763_865f99f7-7d77-443b-bd5d-83cfa54017a1 11822-0763 HUMAN OTC DRUG severe cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140627 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 11822-0766_67b2e638-604a-4bd3-9048-6e3bcfec55ce 11822-0766 HUMAN OTC DRUG infants fever reducer and pain reliever Acetaminophen SUSPENSION ORAL 20111207 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 11822-0775_6f73dda7-6ecc-4c29-9edb-273186aa40f9 11822-0775 HUMAN OTC DRUG Less Drowsy Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 20181111 OTC MONOGRAPH FINAL part336 Rite Aid MECLIZINE HYDROCHLORIDE 25 mg/1 E 20171231 11822-0798_6da6496e-670e-418b-8416-b18d0d8d2a6c 11822-0798 HUMAN OTC DRUG minoxidil Minoxidil SOLUTION TOPICAL 20160818 ANDA ANDA075598 Rite Aid Corporation MINOXIDIL 3 g/60mL N 20181231 11822-0799_cba8033d-e189-493b-a29f-a398c0aba8cb 11822-0799 HUMAN OTC DRUG cough and chest congestion dm max Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20111007 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 11822-0800_7f3c125e-be12-4b2c-bc4e-9469ae7d9258 11822-0800 HUMAN OTC DRUG Miconazole 3 Miconazole nitrate KIT 20140212 ANDA ANDA076357 Rite Aid Corporation N 20181231 11822-0805_32ac09be-041f-4beb-b911-75124ef73940 11822-0805 HUMAN OTC DRUG severe cold and flu relief nighttime acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl TABLET, FILM COATED ORAL 20150715 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 11822-0812_35e30807-0da8-4815-937f-7890c51ebde9 11822-0812 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 500 mg/1 N 20181231 11822-0821_2bd3226e-ee3f-4a9b-9b3e-f6ebd4cc0284 11822-0821 HUMAN OTC DRUG Rite Aid Sensitive Toothpaste Extra Whitening Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20100830 OTC MONOGRAPH NOT FINAL part356 Rite Aid POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g E 20171231 11822-0822_cd85dae2-0747-4881-ad38-30d30cfcbc11 11822-0822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19890815 OTC MONOGRAPH FINAL part347 Rite Aid WITCH HAZEL 86 kg/100L N 20181231 11822-0823_34ae590c-29ed-434c-9bc4-84c1db0de388 11822-0823 HUMAN OTC DRUG First Aid Antibiotic Plus Pain Relief Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hcl OINTMENT TOPICAL 20060601 OTC MONOGRAPH FINAL part333B Rite Aid BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 11822-0839_3c386ae9-dba9-4750-8e0c-0816dd86e84e 11822-0839 HUMAN OTC DRUG childrens mucus relief multi symptom cold dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20140604 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 11822-0843_953001ef-b856-4e8c-a680-5344a7aca828 11822-0843 HUMAN OTC DRUG hemorrhoidal relief Phenylephrine HCl, Witch hazel GEL TOPICAL 20140511 OTC MONOGRAPH FINAL part346 Rite Aid Corporation PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g N 20181231 11822-0850_b721e740-e60d-492e-86fd-f7b459b76d9c 11822-0850 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Rite Aid Corporation LORATADINE 5 mg/5mL N 20181231 11822-0852_1851bff3-ea72-4da1-9e05-d7c2a51f79b6 11822-0852 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20111026 ANDA ANDA091429 Rite Aid Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 11822-0854_8f05d352-0088-4e66-b896-6a561bfbb121 11822-0854 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20071221 ANDA ANDA078546 Rite Aid Corporation NICOTINE 4 mg/1 N 20181231 11822-0861_f343dc80-fe81-4e60-b89d-a74fe44fbd4a 11822-0861 HUMAN OTC DRUG Oil Free Moisturizer Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20160225 OTC MONOGRAPH FINAL part352 Rite Aid OCTINOXATE; OCTISALATE; AVOBENZONE 76.5; 51; 30.6 mg/mL; mg/mL; mg/mL N 20181231 11822-0866_03769180-6c9e-4d6c-ad0f-43aea9b9ad71 11822-0866 HUMAN OTC DRUG lice Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070725 OTC MONOGRAPH FINAL part358G Rite Aid Corporation PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL N 20181231 11822-0871_75aa26bb-9259-4852-92eb-f99d455cab0b 11822-0871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19930111 OTC MONOGRAPH NOT FINAL part333A Rite Aid HYDROGEN PEROXIDE .3 kg/100L N 20181231 11822-0873_a30fda71-bdc5-4c36-bef4-8176e1bf9903 11822-0873 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20060224 ANDA ANDA077007 Rite Aid Corporation NICOTINE 4 mg/1 N 20181231 11822-0876_10e0a001-93f1-4512-8dd9-dfb58400388f 11822-0876 HUMAN OTC DRUG Ethyl Rubbing Alcohol Ethyl Alcohol LIQUID TOPICAL 20090518 OTC MONOGRAPH NOT FINAL part333A Rite Aid ALCOHOL 610 mg/mL N 20181231 11822-0897_1507abd2-77d4-4a44-99dd-a6e4a7a4663a 11822-0897 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990108 ANDA ANDA074937 Rite Aid Corporation IBUPROFEN 100 mg/5mL N 20181231 11822-0898_6996642f-a63e-4be9-aefd-0634e9914c2b 11822-0898 HUMAN OTC DRUG esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170922 ANDA ANDA207193 Rite Aid Corporation ESOMEPRAZOLE 20 mg/1 N 20181231 11822-0899_8154e93b-2b8b-44ad-a82c-8ecce579d458 11822-0899 HUMAN OTC DRUG Enteric Safety Coated Aspirin Aspirin TABLET, COATED ORAL 20040114 20180527 OTC MONOGRAPH NOT FINAL part343 Rite Aid ASPIRIN 81 mg/1 E 20171231 11822-0900_547e8fa4-33e3-4dd2-8e92-e5095e52e03d 11822-0900 HUMAN OTC DRUG Rite Aid Pharmacy congestion relief vaporizing steam Vaporizing steam LIQUID RESPIRATORY (INHALATION) 20141001 OTC MONOGRAPH FINAL part341 Rite Aid Pharmacy CAMPHOR (SYNTHETIC) 6.2 g/118mL N 20181231 11822-0902_a2bec090-c63c-4f54-b3da-eb8e2af655bd 11822-0902 HUMAN OTC DRUG Isopropyl Alcohol 70 percent Isopropyl Alcohol LIQUID TOPICAL 20090722 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 11822-0904_f507907a-d911-4f26-9b4f-81682ddfe7ef 11822-0904 HUMAN OTC DRUG nictoine gum Nicotine polacrilex GUM, CHEWING ORAL 20170117 ANDA ANDA206394 Rite Aid Corporation NICOTINE 2 mg/1 N 20181231 11822-0909_738757f2-c637-47cd-8544-febeeea4aabd 11822-0909 HUMAN OTC DRUG Ethyl Rubbing Alcohol ALCOHOL LIQUID TOPICAL 20090722 20181231 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation ALCOHOL 70 mL/100mL N 20181231 11822-0912_68491231-f019-4757-abc5-a0b3c4c3dff4 11822-0912 HUMAN OTC DRUG menstrual pain relief Maximum strength Acetaminophen, Pamabrom and Pyrilamine maleate TABLET, FILM COATED ORAL 20000620 20190119 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 E 20171231 11822-0915_da243e3c-fc95-402c-92fc-440da3db6c8f 11822-0915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080225 NDA NDA022032 Rite Aid Corporation OMEPRAZOLE 20 mg/1 N 20181231 11822-0916_d363e04e-d2ef-4df9-85f7-c885476d0671 11822-0916 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100616 ANDA ANDA079114 Rite Aid Corporation N 20181231 11822-0944_b377a485-4594-4f60-98da-ff283ed6c23c 11822-0944 HUMAN OTC DRUG Hemorrhoidal Relief glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20080605 OTC MONOGRAPH FINAL part346 Rite Aid Corporation GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 11822-0950_71b4297a-24ef-4f14-a062-ec427bd4749b 11822-0950 HUMAN OTC DRUG cool mint acid reducer Ranitidine TABLET, FILM COATED ORAL 20111207 ANDA ANDA091429 Rite Aid Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 11822-0957_97a4d26b-288b-45da-a4c1-777a20c6aab6 11822-0957 HUMAN OTC DRUG Mini Nicotine Nicotine Polacrilex LOZENGE ORAL 20130119 ANDA ANDA203690 Rite Aid Corporation NICOTINE 4 mg/1 N 20181231 11822-0958_ad95d7c8-c604-4d1d-9352-1d599b25ed76 11822-0958 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130724 ANDA ANDA091135 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 11822-0962_520dc3c7-e8c0-46e8-b82a-a79cdcd7b74c 11822-0962 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160730 OTC MONOGRAPH FINAL part331 Rite Aid Corporation CALCIUM CARBONATE 1000 mg/1 N 20181231 11822-0964_c06e30e9-0aaf-4a91-a676-d58be5e56229 11822-0964 HUMAN OTC DRUG severe cold cough and flu relief nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20150724 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 11822-0969_e1dc5714-ae13-489e-a7e0-46ca4c76b5f2 11822-0969 HUMAN OTC DRUG antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160720 OTC MONOGRAPH FINAL part331 Rite Aid Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 11822-0974_c0043f89-607f-4c6e-a59f-abfc3ed9447f 11822-0974 HUMAN OTC DRUG childrens allergy relief cetirizine hydrochloride LIQUID ORAL 20080417 ANDA ANDA090254 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 11822-0982_09994988-83b2-41bc-8120-27a6cba7d711 11822-0982 HUMAN OTC DRUG Miconazole 3 miconazole nitrate KIT 20060818 ANDA ANDA076357 Rite Aid Corporation N 20181231 11822-0990_94d69d41-b3e3-4395-a3d6-dec72233eb7f 11822-0990 HUMAN OTC DRUG nose Phenylephrine hydrochloride SOLUTION/ DROPS NASAL 19890815 OTC MONOGRAPH FINAL part341 Rite Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 11822-0994_a7b63f79-5ffc-490d-b92a-b4a5539d423a 11822-0994 HUMAN OTC DRUG cold and flu relief daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20120907 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 11822-1000_09184b06-a315-4c74-abb4-3811a71c6a88 11822-1000 HUMAN OTC DRUG Rite Aid Instant Hand Sanitizer With Moisturizers ALCOHOL GEL TOPICAL 20091210 OTC MONOGRAPH NOT FINAL part333 Rite Aid Corporation ALCOHOL 62 mL/100mL E 20171231 11822-1001_47e1e1cd-a252-55f8-e054-00144ff8d46c 11822-1001 HUMAN OTC DRUG Daylogic Oil-free Cleansing wipe for acne-prone skin pink grapefruit salicylic acid CLOTH TOPICAL 20170101 OTC MONOGRAPH FINAL part333D Rite Aid SALICYLIC ACID 20 mg/mL N 20181231 11822-1020_0f387232-0f83-4afc-83a2-89f96f36fa19 11822-1020 HUMAN OTC DRUG Daylogic White Tea Hand Wash Benzalkonium Chloride SOAP TOPICAL 20170427 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11822-1020_3270c4c0-28e9-463f-8883-c8702b75d9ed 11822-1020 HUMAN OTC DRUG Daylogic White Tea Hand Wash Benzalkonium Chloride SOAP TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11822-1031_c03558fb-184a-40c8-91c5-9b664abfacb4 11822-1031 HUMAN OTC DRUG Rite Aid Baby Care Benzocaine GEL, DENTIFRICE ORAL 20110120 OTC MONOGRAPH FINAL part333B Rite Aid BENZOCAINE 7.5 g/100g N 20181231 11822-1090_0c7e83df-df24-48cd-a45f-f0d11bea6c52 11822-1090 HUMAN OTC DRUG Daylogic Fresh Pear Foaming Benzalkonium Chloride SOAP TOPICAL 20170509 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11822-1090_8393255e-9219-4fb8-ac96-1b54a165198a 11822-1090 HUMAN OTC DRUG Daylogic Fresh Pear Foaming Benzalkonium Chloride SOAP TOPICAL 20160807 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11822-1105_dc44466d-afd9-46fc-bb35-9146490471dc 11822-1105 HUMAN OTC DRUG First Aid Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20120223 OTC MONOGRAPH FINAL part333B Rite Aid BACITRACIN ZINC 500 [USP'U]/g N 20181231 11822-1110_3b874e01-dbfb-460d-bcfb-52be8e4819dd 11822-1110 HUMAN OTC DRUG Rite Aid antifungal ringworm Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C Rite Aid Corporation CLOTRIMAZOLE 1 g/100g N 20181231 11822-1111_4bce0359-73b6-479e-9e20-22989bf75725 11822-1111 HUMAN OTC DRUG Ultimate Sheer Sunscreen SPF 85 Rite Aid Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 4.50% Oxybenzone 6.00% LOTION TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part352 Ride Aid AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 4.5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 11822-1112_4914ba7f-290c-4313-97f9-70d88724cb51 11822-1112 HUMAN OTC DRUG Ultimate Sheer Sunscreen SPF 100 Rite Aid Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 10.00% Oxybenzone 6.00% LOTION TOPICAL 20120525 OTC MONOGRAPH NOT FINAL part352 Rite Aid AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 11822-1113_c0012880-9f76-4a19-9a3d-5dc8c2e9290f 11822-1113 HUMAN OTC DRUG Sunscreen SPF 30 Daylogic Avobenzone 2.00% Homosalate 10.50% Octisalate 5.00% Octocrylene 2.00% Oxybenzone 2.00% LOTION TOPICAL 20161130 OTC MONOGRAPH NOT FINAL part352 Rite Aid AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10.5; 5; 2; 2 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 11822-1120_94f41f72-9a0a-441c-9207-b53f6470dbd5 11822-1120 HUMAN OTC DRUG RITE AID RENEWAL PEAR TRICLOSAN LIQUID TOPICAL 20130325 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 4.6 mg/mL N 20181231 11822-1130_c755d71b-9431-4fd0-85cf-cd00d14fe61a 11822-1130 HUMAN OTC DRUG RITE AID RENEWAL WHITE TEA TRICLOSAN LIQUID TOPICAL 20130325 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 4.6 mg/mL N 20181231 11822-1240_310df6a3-7efb-4c7d-b063-b5e13e444e65 11822-1240 HUMAN OTC DRUG Daylogic Antibacterial Foaming Wash Benzalkonium Chloride SOAP TOPICAL 20160818 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11822-1240_ba0e9a53-e4bd-40cd-91fb-31b97826f785 11822-1240 HUMAN OTC DRUG Daylogic Antibacterial Foaming Wash Benzalkonium Chloride SOAP TOPICAL 20170428 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11822-1243_b6c2bb8b-e3ab-4983-aa3f-c37410bf0c77 11822-1243 HUMAN OTC DRUG Daylogic Antibacterial Foaming Wash Refill Benzalkonium Chloride LIQUID TOPICAL 20170523 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11822-1243_f6ec90d2-9656-43f0-a883-7a1a71645935 11822-1243 HUMAN OTC DRUG Daylogic Antibacterial Foaming Wash Refill Benzalkonium Chloride LIQUID TOPICAL 20161020 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11822-1250_51c19218-5188-485f-a2cb-6ee9704d9e48 11822-1250 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION ORAL 20100517 ANDA ANDA079058 Rite Aid IBUPROFEN 50 mg/1.25mL N 20191231 11822-1261_9223dfb2-e4ed-40b1-b8d8-07725aeb330f 11822-1261 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080320 20190831 ANDA ANDA074916 Rite Aid IBUPROFEN 100 mg/5mL N 20191231 11822-1403_3c3dd86d-d034-4955-a203-168ca2146ae2 11822-1403 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090730 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 11822-1403_7ca972ea-94a8-4ea8-b9f2-aa200726daea 11822-1403 HUMAN OTC DRUG Night Time Cherry Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090730 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 11822-1405_5593f822-8179-4f52-a9b3-2136be90c746 11822-1405 HUMAN OTC DRUG Rite Aid Zinc SPF 50 OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20160107 OTC MONOGRAPH NOT FINAL part352 Rite Aid OCTOCRYLENE; ZINC OXIDE 4; 5 g/100g; g/100g N 20181231 11822-1406_b40449b3-eadd-41e5-a06e-bd49db18633b 11822-1406 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090520 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 11822-1406_db1bfe7b-bc5a-491c-ab46-7fbd3fc54cb5 11822-1406 HUMAN OTC DRUG Night Time Original Pseudo-Free Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20090520 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 11822-1417_0020e055-c814-4bc5-8bd9-93ba51479684 11822-1417 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20090730 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 11822-1434_657981c6-d546-4116-b731-8d74905d0be0 11822-1434 HUMAN OTC DRUG Childrens Plus Multi-Symptom Cold Grape with PE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE SUSPENSION ORAL 20090811 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 11822-1536_70994e7c-ee0d-4aa5-98c7-491aa1501d97 11822-1536 HUMAN OTC DRUG Rite Aid Original Sterile Eye Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20160421 OTC MONOGRAPH FINAL part349 Rite Aid Corporation TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 11822-1590_5111c044-dc18-4c0d-a97e-0aabc06cfc87 11822-1590 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 11822-1645_18471e7d-1097-45b9-b9a9-54786fe6097f 11822-1645 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120523 ANDA ANDA091292 Rite Aid Corporation LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 11822-1683_dafaa2be-a718-449a-98a3-38df3e82e469 11822-1683 HUMAN OTC DRUG Rite Aid Foaming Hand TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .6 mL/100mL N 20181231 11822-1770_b1a2b8cb-f071-4bc0-b931-e1f6d6b6e7c4 11822-1770 HUMAN OTC DRUG RITE AID RENEWAL ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20130325 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 4.6 mg/mL N 20181231 11822-1773_e5a62e8d-bca1-4399-a8b7-15bbc1be44d5 11822-1773 HUMAN OTC DRUG RITE AID RENEWAL ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .46 mg/100mL N 20181231 11822-1793_9f287aa6-4b99-4400-9bb7-ba4bfca7ec4b 11822-1793 HUMAN OTC DRUG RITE AID RENEWAL TRICLOSAN LIQUID TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 4.6 mg/mL N 20181231 11822-1809_6b8665cd-aaea-4863-aede-d962bd92a904 11822-1809 HUMAN OTC DRUG Rite Aid Eye Care Lubricant Carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20170518 OTC MONOGRAPH FINAL part349 Rite Aid Corporation CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 11822-1820_1d107bd7-55d0-4f04-ac68-310bbdc34794 11822-1820 HUMAN OTC DRUG Rite Aid Sport Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY TOPICAL 20160303 OTC MONOGRAPH NOT FINAL part352 Rite Aid AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 11822-1830_976bdfb0-2d8b-4f31-b5a6-a2a932a06f21 11822-1830 HUMAN OTC DRUG Rite Aid Sport SPF 30 8 oz Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20160303 OTC MONOGRAPH NOT FINAL part352 Rite Aid AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g N 20181231 11822-1840_d2a2c960-b850-4802-873a-76c325acbaee 11822-1840 HUMAN OTC DRUG Rite Aid Sport SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160304 OTC MONOGRAPH NOT FINAL part352 Rite Aid AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 11.7; 4.5; 4.5; 5.4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-1880_252a7345-2df4-433f-91db-58c7c92601bc 11822-1880 HUMAN OTC DRUG RITE AID RENEWAL WHITE TEA TRICLOSAN LIQUID TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 4.6 mg/mL N 20181231 11822-2004_db4c4ea4-794a-441d-ac80-aa23856008cf 11822-2004 HUMAN OTC DRUG Childrens Allergy Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine HCI LIQUID ORAL 20090904 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 11822-2092_d23a822a-dccf-4193-a79a-06154f3476de 11822-2092 HUMAN OTC DRUG Childrens Allergy Relief Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Rite Aid Corporation LORATADINE 5 mg/5mL N 20181231 11822-2099_28a0ccfa-cecd-400d-8312-72339069e235 11822-2099 HUMAN OTC DRUG Rite Aid anti-itch Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation HYDROCORTISONE 1 g/100g N 20181231 11822-2100_70b93a28-8be8-42d7-b6eb-8d162283b2a8 11822-2100 HUMAN OTC DRUG Athletes Foot Butenafine Hydrochloride CREAM TOPICAL 20171117 ANDA ANDA205181 Rite Aid Corporation BUTENAFINE HYDROCHLORIDE 10 mg/g N 20181231 11822-2102_91d6ab05-f0f4-4779-839e-9c2fc2529709 11822-2102 HUMAN OTC DRUG Rite Aid childrens allergy relief Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 11822-2104_d8e61a79-c69e-4402-abec-2d52ae0c6f7b 11822-2104 HUMAN OTC DRUG Flu Relief Therapy Day Time Acetaminophen, Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride LIQUID ORAL 20090904 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 11822-2106_7e15962f-0507-4474-9504-6fc6c59312b1 11822-2106 HUMAN OTC DRUG Rite Aid childrens allergy relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 11822-2108_4810a985-a9e8-4d09-937d-6d03c966cae7 11822-2108 HUMAN OTC DRUG RENEWAL TRICLOSAN LIQUID TOPICAL 20110318 OTC MONOGRAPH NOT FINAL part333E RITE AID TRICLOSAN .115 L/100L N 20181231 11822-2112_a2d63bad-4e8e-4477-872a-750de9bc7f47 11822-2112 HUMAN OTC DRUG Rite Aid Daytime Severe Cold and Cough Relief Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 11822-2113_9139f9de-61d0-44fa-9324-2e466ec8e1a7 11822-2113 HUMAN OTC DRUG Rite Aid Nighttime Severe Cold and Cough Relief Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 11822-2131_dfebc06e-d648-4ae9-b16d-58e07b9f61dd 11822-2131 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Rite Aid Corporation LORATADINE 5 mg/5mL N 20181231 11822-2160_4b11bec0-6514-40da-a00d-9c36846b373c 11822-2160 HUMAN OTC DRUG RITE AID RENEWAL ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20121221 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 1.5 mg/mL N 20181231 11822-2180_ddeaf3ed-aad5-4c3e-b2a5-b4382efd2d12 11822-2180 HUMAN OTC DRUG Pain Relief Aspirin Low Dose Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ASPIRIN 81 mg/1 N 20181231 11822-2202_a501cb53-ee7e-4807-bfac-dead2a21a347 11822-2202 HUMAN OTC DRUG Rite Aid Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .15 mL/100mL N 20181231 11822-2203_34f0d519-af00-4f55-9079-85d407dcb762 11822-2203 HUMAN OTC DRUG Rite Aid Liquid TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .15 mL/100mL N 20181231 11822-2222_61ce33c3-c000-52bf-e053-2a91aa0a1221 11822-2222 HUMAN OTC DRUG Age Perfecting SPF 15 Sunscreen Daylogic Ensulizole 1.70% Octinoxate 7.50% CREAM TOPICAL 20160830 OTC MONOGRAPH NOT FINAL part352 Rite Aid ENSULIZOLE; OCTINOXATE 1.7; 7.5 g/100g; g/100g N 20191231 11822-2223_61d1776d-8cea-4124-e053-2a91aa0ab222 11822-2223 HUMAN OTC DRUG Sport Sunscreen SPF 50 Daylogic Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 5.00% SPRAY TOPICAL 20160808 OTC MONOGRAPH NOT FINAL part352 Rite Aid AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 5 g/100g; g/100g; g/100g; g/100g N 20191231 11822-2224_61d1df56-a529-e37a-e053-2991aa0a0758 11822-2224 HUMAN OTC DRUG Sport Sunscreen SPF 30 Daylogic Avobenzone 2.00% Homosalate 7.00% Octocrylene 5.00% SPRAY TOPICAL 20161222 OTC MONOGRAPH NOT FINAL part352 Rite Aid AVOBENZONE; HOMOSALATE; OCTOCRYLENE 2; 7; 5 g/100g; g/100g; g/100g N 20191231 11822-2250_12524941-9597-4a6e-b4cb-4641815839ea 11822-2250 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 RITE AID CORPORATION ALCOHOL 62 mL/100mL N 20181231 11822-2253_45920523-9754-4043-a665-613a4e7e2b17 11822-2253 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 RITE AID CORPORATION ALCOHOL 62 mL/100mL N 20181231 11822-2350_c3a21850-8482-42b7-82f3-630831fad10f 11822-2350 HUMAN OTC DRUG Pain Relief Acetaminophen PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 11822-2366_257c0298-301e-4a23-949d-b8916b82448f 11822-2366 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20170228 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 11822-2440_a0ba2be9-681e-4ad4-bc78-e5ac141acee6 11822-2440 HUMAN OTC DRUG Daylogic Foaming Sanitizer Aloe Benzalkonium Chlolride LIQUID TOPICAL 20160209 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 11822-2461_af64b798-7ca5-4372-bb38-c1ba3ead7463 11822-2461 HUMAN OTC DRUG Renewal Eczema Moisturizing Colloidal Oatmeal CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Rite Aid Corporation OATMEAL 1 g/100g N 20181231 11822-2552_67839e88-b6f1-4ab9-a966-dd56a7351c42 11822-2552 HUMAN OTC DRUG Rite Aid Advanced Sterile Eye Dextran 70, Polyethylene Glycol 400, Povidones, and Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20160421 OTC MONOGRAPH FINAL part349 Rite Aid Corporation DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11822-2683_dce46afe-898a-47c9-b72e-2c76455af7f5 11822-2683 HUMAN OTC DRUG RITE AID RENEWAL MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL LIQUID TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION ALCOHOL 620 mg/mL N 20181231 11822-2701_1d8d3b13-27e4-4789-a5ec-c0d8f1b4cfc4 11822-2701 HUMAN OTC DRUG lubricant eye Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20150424 OTC MONOGRAPH FINAL part349 Rite Aid POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 11822-2890_e8b22e2e-5f72-4520-b460-e5b423df3b3e 11822-2890 HUMAN OTC DRUG BENZOCAINE and RESORCINOL BENZOCAINE and RESORCINOL OINTMENT TOPICAL 20090519 OTC MONOGRAPH NOT FINAL part348 RiteAid BENZOCAINE; RESORCINOL 200; 20 mg/g; mg/g E 20171231 11822-2891_eb64015e-ac53-45f0-8c60-97de3570ceaa 11822-2891 HUMAN OTC DRUG Rite Aid Original Strength Vagicaine BENZOCAINE and RESORCINOL CREAM TOPICAL 20100719 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation BENZOCAINE; RESORCINOL 50; 20 mg/g; mg/g E 20171231 11822-2943_e0dd6a2b-5028-4f9e-8b7a-5b791ed73688 11822-2943 HUMAN OTC DRUG RITE AID RENEWAL ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .15 mg/100mL N 20181231 11822-2953_a8333979-72a8-494c-8dd3-2e9f849c4f62 11822-2953 HUMAN OTC DRUG Daylogic Antibacterial Gold Refill Benzalkonium Chloride LIQUID TOPICAL 20161005 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11822-3025_6867702f-c8e3-41cc-806e-4523c7a07543 11822-3025 HUMAN OTC DRUG Lubricant / Redness Reliever Naphazoline Hydrochloride and Hypromellose SOLUTION/ DROPS OPHTHALMIC 20100902 OTC MONOGRAPH FINAL part349 Rite Aid Corporation NAPHAZOLINE HYDROCHLORIDE; HYPROMELLOSES 5; .3 mg/mL; mg/mL N 20181231 11822-3108_d63e1e2f-dbd7-440b-b6f4-3e1493a2e190 11822-3108 HUMAN OTC DRUG Oral Care Antiseptic Eucalyptol, enthol, Methyl salicylate, Thymol MOUTHWASH ORAL 19901015 OTC MONOGRAPH NOT FINAL part356 Rite Aid EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11822-3150_fa9433f8-b098-4c19-a643-4d154846d397 11822-3150 HUMAN OTC DRUG Daylogic baby SPF 60 Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20160308 OTC MONOGRAPH NOT FINAL part352 Rite Aid TITANIUM DIOXIDE; ZINC OXIDE 4.9; 4.7 g/100g; g/100g N 20181231 11822-3201_43643537-8dfa-45d1-a1a3-a280e1465f8b 11822-3201 HUMAN OTC DRUG DAILY MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 RITE AID CORPORATION DIMETHICONE 1.25 mL/100mL N 20181231 11822-3202_c02f699a-9e6c-4789-8fcf-db6c579a83b5 11822-3202 HUMAN OTC DRUG RITE AID RENEWAL DAILY MOISTURIZING DIMETHICONE LIQUID TOPICAL 20120925 OTC MONOGRAPH FINAL part347 RITE AID CORPORATION DIMETHICONE 12.5 mg/mL N 20181231 11822-3207_98fddfdc-e289-4218-8cd7-a188eb8db88c 11822-3207 HUMAN OTC DRUG Renewal 7-in-1 Anti-Aging Vitamin Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120517 OTC MONOGRAPH NOT FINAL part352 Rite Aid Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mL/100mL; mL/100mL; mL/100mL N 20181231 11822-3215_1585a1ae-5be4-4e16-ad06-6b710bb5fedf 11822-3215 HUMAN OTC DRUG Original Redness Reliever Naphazoline Hydrochloride and Polyethylene glycol 300 SOLUTION/ DROPS OPHTHALMIC 20100913 OTC MONOGRAPH FINAL part349 Rite Aid Corporation NAPHAZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 300 .1; 2 mg/mL; mg/mL N 20181231 11822-3271_96838b7f-aa9c-4ac3-ae87-065ae98f419a 11822-3271 HUMAN OTC DRUG Baby Care Vitamins A and D Lanolin OINTMENT TOPICAL 20140305 OTC MONOGRAPH FINAL part347 Rite Aid Corporation LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g N 20181231 11822-3300_38a19499-c16a-41ce-b296-46d8e9294f74 11822-3300 HUMAN OTC DRUG HYDRATING HEALING DAILY THRAPY PETROLATUM OINTMENT TOPICAL 20100719 OTC MONOGRAPH FINAL part347 RITE AID PETROLATUM 41 g/100g N 20181231 11822-3301_a4d67f13-8d9e-411e-a693-1539b240a4e0 11822-3301 HUMAN OTC DRUG HYDRATING HEALING DAILY THRAPY PETROLATUM OINTMENT TOPICAL 20100719 OTC MONOGRAPH FINAL part347 RITE AID PETROLATUM 41 g/100g N 20181231 11822-3303_db573480-8363-4dfb-a968-d58c416f794a 11822-3303 HUMAN OTC DRUG RITE AID RENEWAL PETROLATUM JELLY TOPICAL 20121030 OTC MONOGRAPH FINAL part346 RITE AID CORPORATION PETROLATUM 410 mg/g N 20181231 11822-3312_5da2ea79-f37b-b82b-e053-2a91aa0af0af 11822-3312 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20111014 OTC MONOGRAPH NOT FINAL part334 Rite Aid Corporation GLYCERIN 2 g/1 N 20181231 11822-3321_5da451ac-c799-2af5-e053-2991aa0aa470 11822-3321 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20120216 OTC MONOGRAPH NOT FINAL part334 Rite Aid Corporation GLYCERIN 1 g/1 N 20181231 11822-3324_6027037d-d206-7eab-e053-2991aa0a3f45 11822-3324 HUMAN OTC DRUG REGULAR STRENGTH ANTACID AND GAS RELIEF aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20140401 OTC MONOGRAPH FINAL part331 RITE AID PHARMACY ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 11822-3329_5fb302b7-2e84-7a7b-e053-2991aa0ace8e 11822-3329 HUMAN OTC DRUG MILK OF MAGNESIA magnesium hydroxide SUSPENSION ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 RITE AID PHARMACY MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 11822-3351_dd309d13-5798-415a-968c-845113bc3d6e 11822-3351 HUMAN OTC DRUG RENEWAL MEDICATED MENTHOL - DIMETHICONE LOTION TOPICAL 20100714 OTC MONOGRAPH FINAL part347 RITE AID MENTHOL; DIMETHICONE .5; 5 mL/100mL; mL/100mL N 20181231 11822-3401_9cec1a5c-9771-4b6f-8594-c32a817d9f4a 11822-3401 HUMAN OTC DRUG VITAMINS A AND D DIAPER RASH LANOLIN AND PETROLATUM OINTMENT TOPICAL 20110104 OTC MONOGRAPH FINAL part346 RITE AID LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g N 20181231 11822-3410_960eece5-bd7b-4185-9456-a84039f26e05 11822-3410 HUMAN OTC DRUG RITE AID RENEWAL SUNSCREEN ENSULIZOLE LOTION TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 2; 7.5; 7.5; 1.9 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 11822-3416_ac94969f-0313-44e2-a7ce-e09037c9b920 11822-3416 HUMAN OTC DRUG Day Time with PE Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine HCI LIQUID ORAL 20090813 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 11822-3420_79d76f31-4786-4b95-b6ab-44aa525bcaff 11822-3420 HUMAN OTC DRUG RENEWAL DAILY MOISTURIZER SENSITIVE SKIN ZINCE OXIDE LOTION TOPICAL 20110721 OTC MONOGRAPH FINAL part346 RITE AID CORPORATION TITANIUM DIOXIDE; ZINC OXIDE 5; 3 mL/100mL; mL/100mL N 20181231 11822-3430_5a2d31d9-6369-4b11-b4a6-bb5fcfc1139b 11822-3430 HUMAN OTC DRUG Daylogic Tinted Daily Moisturizer SPF 30 Ensulizole, Octinoxate, Oxybenzone, Zinc Oxide LOTION TOPICAL 20170813 OTC MONOGRAPH NOT FINAL part352 Rite Aid Corporation ENSULIZOLE; OCTINOXATE; OXYBENZONE; ZINC OXIDE 20; 75; 60; 50 mg/mL; mg/mL; mg/mL; 1/mL N 20181231 11822-3540_54aa092c-b4c1-4a0e-bafa-a32af7090603 11822-3540 HUMAN OTC DRUG RITE AID RENEWAL ADVANCED HEALING PETROLATUM OINTMENT TOPICAL 20120622 OTC MONOGRAPH FINAL part346 RITE AID CORPORATION PETROLATUM 41 g/100g N 20181231 11822-3541_b8b9119d-ed4d-4024-a433-e62dcfcc8b48 11822-3541 HUMAN OTC DRUG RITE AID RENEWAL HYDRATING PETROLATUM JELLY TOPICAL 20121015 OTC MONOGRAPH FINAL part346 RITE AID CORPORATION PETROLATUM 410 mg/g N 20181231 11822-3601_50bbb728-80ef-42a3-a1d9-5689944aa06a 11822-3601 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20090416 OTC MONOGRAPH NOT FINAL part334 Rite Aid Corporation MINERAL OIL 15 mL/15mL N 20181231 11822-3644_58f1f79f-f1de-3094-e053-2991aa0ac591 11822-3644 HUMAN OTC DRUG EAR CARE EARACHE DROPS ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, and SULFUR LIQUID AURICULAR (OTIC) 20170803 UNAPPROVED HOMEOPATHIC Rite Aid Corporation ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA CHAMOMILLA; LYCOPODIUM CLAVATUM SPORE; ANEMONE PULSATILLA; SULFUR 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 11822-3670_8a103e2f-bfcb-4688-bd0b-cb78e035a482 11822-3670 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 11822-3678_2b9443fd-8849-2352-e054-00144ff8d46c 11822-3678 HUMAN OTC DRUG Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% LIQUID TOPICAL 20130101 NDA NDA019125 Rite Aid Corporation CHLORHEXIDINE GLUCONATE 4 mg/100mL N 20181231 11822-3698_cdb59ab5-d277-6e78-06a1-b1365467fdc2 11822-3698 HUMAN OTC DRUG Allergy Relief Fexofenadine hydrochloride TABLET ORAL 20110103 ANDA ANDA076502 Rite Aid Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 11822-3700_c912e9b6-8f46-475a-b069-92e187c7f319 11822-3700 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A Rite Aid ALCOHOL 70 mL/100mL N 20181231 11822-3705_1c20cdd2-4e79-4edb-8137-36e7f7d5ee23 11822-3705 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 19940104 OTC MONOGRAPH FINAL part355 Rite Aid SODIUM FLUORIDE .1 mg/mL N 20181231 11822-3720_2bb28094-c080-48af-a8c2-103b3fe9dc09 11822-3720 HUMAN OTC DRUG Mucus Relief Plus Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20020727 20181109 OTC MONOGRAPH NOT FINAL part343 Rite Aid ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 11822-3724_e40e041a-e597-4566-8b6f-ddf20c9d28cf 11822-3724 HUMAN OTC DRUG Antiseptic Night Rinse Cetylpyridinium Chloride MOUTHWASH ORAL 20090317 OTC MONOGRAPH NOT FINAL part356 Rite Aid CETYLPYRIDINIUM CHLORIDE .07 kg/100L N 20181231 11822-3727_6014342d-ad47-ae71-e053-2991aa0a8929 11822-3727 HUMAN OTC DRUG MAXIMUM STRENGTH ANTACID AND GAS RELIEF aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20140401 OTC MONOGRAPH FINAL part331 RITE AID PHARMACY ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 11822-3729_42867de3-3168-4944-bc5f-76aa1f3f8c7c 11822-3729 HUMAN OTC DRUG Rite Aid Cold and Hot Medicated Menthol PATCH TOPICAL 20100629 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation MENTHOL, UNSPECIFIED FORM 50 g/1 N 20181231 11822-3775_5df6fef0-4e0f-9cb8-e053-2a91aa0a21e5 11822-3775 HUMAN OTC DRUG Rite Aid Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation POVIDONE-IODINE 100 mg/mL N 20181231 11822-3801_d988711a-dd00-4316-8885-ac488a8c3499 11822-3801 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090320 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 11822-3865_332d847f-ee44-492a-ad81-2f5bde44ce5e 11822-3865 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20100831 NDA NDA020065 Rite Aid Corporation NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL N 20181231 11822-3904_65ca2c05-efa6-488c-a8c8-5c062f1f86af 11822-3904 HUMAN OTC DRUG Rite Aid Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20091222 OTC MONOGRAPH NOT FINAL part333 Rite Aid Corporation ALCOHOL 62 mL/100mL E 20171231 11822-3950_0273d979-c311-44e0-a2a7-16d1f27ff44e 11822-3950 HUMAN OTC DRUG Rite Aid Liquid Anesthetic Oral Pain Relief BENZOCAINE GEL ORAL 20100708 OTC MONOGRAPH FINAL part356 Rite Aid Corporation BENZOCAINE 200 mg/mL E 20171231 11822-3957_04deebef-abbf-4f24-9f8a-dbafe87835e8 11822-3957 HUMAN OTC DRUG Alcohol Swabs with Benzocaine benzocaine SWAB TOPICAL 20090701 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 E 20171231 11822-4070_1e8e18be-e648-4a46-ac8c-db0ee614de9d 11822-4070 HUMAN OTC DRUG Rite Aid Cold Sore Treatment Camphor CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Rite Aid CAMPHOR (SYNTHETIC); BENZALKONIUM CHLORIDE 30; 1.3 mg/g; mg/g N 20181231 11822-4073_c7caf6f7-6dd1-4527-b91a-2802f03461da 11822-4073 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090819 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 11822-4101_324f90ad-2a4b-4757-b616-aa233856d205 11822-4101 HUMAN OTC DRUG Rite Aid Dandruff 2 in 1 Classic Clean Pyrithione Zinc SHAMPOO TOPICAL 20101020 OTC MONOGRAPH FINAL part358H Rite Aid Corporation PYRITHIONE ZINC 1 mL/100mL N 20181231 11822-4111_8942402b-330a-4cb3-90e0-c06b66e3c39f 11822-4111 HUMAN OTC DRUG Rite Aid Dandruff 2 in 1 Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20101020 OTC MONOGRAPH FINAL part358H Rite Aid Corporation PYRITHIONE ZINC 1 mL/100mL N 20181231 11822-4130_390b5244-b47d-4b23-b9d5-0ff6779bd8f0 11822-4130 HUMAN OTC DRUG pain relief back and body EXTRA STRENGTH Aspirin, Caffeine TABLET, FILM COATED ORAL 20040412 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 N 20181231 11822-4141_e84ba10c-9bb4-4e61-8c89-b3746afa2b66 11822-4141 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090826 OTC MONOGRAPH NOT FINAL part356 Rite Aid Corporation HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 11822-4175_24fa5c4c-1e2d-58bf-e054-00144ff8d46c 11822-4175 HUMAN OTC DRUG Menthol Menthol LOZENGE ORAL 20110701 OTC MONOGRAPH FINAL part341 Rite Aid MENTHOL 5.8 mg/1 N 20181231 11822-4201_492a183a-8adf-4a13-85a5-b35d533d4f25 11822-4201 HUMAN OTC DRUG eye itch relief ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC 20131206 ANDA ANDA077958 Rite Aid Corporation KETOTIFEN FUMARATE .35 mg/mL N 20181231 11822-4202_7ae76b30-68ff-4263-818e-a5d0b48935cb 11822-4202 HUMAN OTC DRUG eye itch relief ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC 20131206 ANDA ANDA077958 Rite Aid Corporation KETOTIFEN FUMARATE .35 mg/mL N 20181231 11822-4242_053f684b-2595-4079-829f-535934ea02e2 11822-4242 HUMAN OTC DRUG Daylogic 2in1 Dandruff Classic Clean Pyrithione Zinc LIQUID TOPICAL 20160209 OTC MONOGRAPH FINAL part358H RITE AID CORPORATION PYRITHIONE ZINC 10 mg/mL N 20181231 11822-4242_8b2388de-6aba-4dc2-ae82-152debf06d8c 11822-4242 HUMAN OTC DRUG Daylogic 2in1 Dandruff Classic Clean Pyrithione Zinc LIQUID TOPICAL 20170409 OTC MONOGRAPH FINAL part358H Rite Aid Corporation PYRITHIONE ZINC 10 mg/mL N 20181231 11822-4251_692ad047-f358-40c9-a5e4-590bc3fd136f 11822-4251 HUMAN OTC DRUG Daylogic 2in1 Dandruff Dry Scalp Care Pyrithione Zinc LIQUID TOPICAL 20170606 OTC MONOGRAPH FINAL part358H Rite Aid Corporation PYRITHIONE ZINC 10 mg/mL N 20181231 11822-4251_76e45790-577d-4e91-bae7-0e8f3b24b57e 11822-4251 HUMAN OTC DRUG Daylogic 2in1 Dandruff Dry Scalp Care Pyrithione Zinc LIQUID TOPICAL 20160209 OTC MONOGRAPH FINAL part358H RITE AID CORPORATION PYRITHIONE ZINC 10 mg/mL N 20181231 11822-4272_081f92c9-1ffb-4173-bd86-66a0eb75447f 11822-4272 HUMAN OTC DRUG Daylogic Dandruff Classic Clean Pyrithione Zinc LIQUID TOPICAL 20160209 OTC MONOGRAPH FINAL part358H RITE AID CORPORATION PYRITHIONE ZINC 10 mg/mL N 20181231 11822-4272_913cafb7-a69e-4180-868b-661ad710c09b 11822-4272 HUMAN OTC DRUG Daylogic Dandruff Classic Clean Pyrithione Zinc LIQUID TOPICAL 20170504 OTC MONOGRAPH FINAL part358H Rite Aid Corporation PYRITHIONE ZINC 10 mg/mL N 20181231 11822-4292_48751c7a-4d11-4518-8711-d6b1f0047a8b 11822-4292 HUMAN OTC DRUG Daylogic Dry Scalp Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20160614 OTC MONOGRAPH FINAL part358H Rite Aid Corporation PYRITHIONE ZINC 10 mg/mL N 20181231 11822-4292_c01fd0e8-182f-42d8-a125-75fe443531c0 11822-4292 HUMAN OTC DRUG Daylogic Dry Scalp Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20170531 OTC MONOGRAPH FINAL part358H Rite Aid Corporation PYRITHIONE ZINC 10 mg/mL N 20181231 11822-4332_3b9ce1ae-7acc-4533-b0c1-34ac416b22a7 11822-4332 HUMAN OTC DRUG Daylogic 2 in 1 Dandruff Classic Scent Pyrithione Zinc SHAMPOO TOPICAL 20170425 OTC MONOGRAPH FINAL part358H Rite Aid Corporation PYRITHIONE ZINC 10 mg/mL N 20181231 11822-4332_45d1aa96-b84c-4279-b339-754ea30ecd1e 11822-4332 HUMAN OTC DRUG Daylogic 2 in 1 Dandruff Classic Scent Pyrithione Zinc SHAMPOO TOPICAL 20160614 OTC MONOGRAPH FINAL part358H Rite Aid Corporation PYRITHIONE ZINC 10 mg/mL N 20181231 11822-4352_5df71189-9b2a-9dee-e053-2a91aa0a9e49 11822-4352 HUMAN OTC DRUG Rite Aid Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Rite Aid Corporation ZINC OXIDE 160 mg/mL N 20181231 11822-4362_dbac77c8-09b3-4be2-abec-5def2a462916 11822-4362 HUMAN OTC DRUG Daylogic Refresh Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20160614 OTC MONOGRAPH FINAL part358H Rite Aid Corporation PYRITHIONE ZINC 10 mg/mL N 20181231 11822-4429_606c5b81-9240-4ed7-8ab4-3a43aa630a98 11822-4429 HUMAN OTC DRUG RITE AID tugaboos OATMEAL CREAM TOPICAL 20150315 OTC MONOGRAPH FINAL part347 Rite Aid OATMEAL 1 g/100g N 20181231 11822-4450_1f30e281-5ab3-49dc-8cea-b66758a8b0e2 11822-4450 HUMAN OTC DRUG pain relief childrens acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/1 N 20181231 11822-4500_b45076fc-e095-498e-8ae1-6a709c01d377 11822-4500 HUMAN OTC DRUG RENEWAL ANTI-DANDRUFF SALICYLIC ACID LIQUID TOPICAL 20141208 OTC MONOGRAPH FINAL part333D RITE AID CORPORATION SALICYLIC ACID 20 mg/mL N 20181231 11822-4530_a1e5ece3-ccaf-43ea-bda8-8d4f6e21bc24 11822-4530 HUMAN OTC DRUG Sinus Pressure and Congestion Relief PE Maximum Strength Phenylephrine HCl TABLET, COATED ORAL 20040616 OTC MONOGRAPH FINAL part341 Rite Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 11822-4591_1b19148a-3d2c-4d1d-b808-3fc39a31f0b7 11822-4591 HUMAN OTC DRUG Renewal Anti-Wrinkle Avobenzone and Octocrylene CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Rite Aid Corporation AVOBENZONE; OCTOCRYLENE 3; 10 g/100g; g/100g N 20181231 11822-4600_f69c5dcb-39e1-4e5a-afd7-27aaf3f9c3ea 11822-4600 HUMAN OTC DRUG Rite Aid fast relief laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20141001 OTC MONOGRAPH NOT FINAL part334 Rite Aid Pharmacy BISACODYL 10 mg/2000mg N 20181231 11822-4601_b06683ca-4cac-4ce6-8390-d5650a43cf92 11822-4601 HUMAN OTC DRUG Rite Aid fast relief laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20141002 OTC MONOGRAPH NOT FINAL part334 Rite Aid Pharmacy BISACODYL 10 mg/2000mg N 20181231 11822-4610_84ad5754-04ff-4a3a-b07c-1714508dbb3a 11822-4610 HUMAN OTC DRUG cold and flu relief hbp MAXIMUM STRENGTH multi-symptom Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr TABLET, FILM COATED ORAL 20050601 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 500; 2; 15 mg/1; mg/1; mg/1 N 20181231 11822-4650_95d28594-88c9-419c-9ab0-395dd8a938bd 11822-4650 HUMAN OTC DRUG PURE SPRING ETHYL ALCOHOL LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E RITE AID ALCOHOL 62 mL/100mL N 20181231 11822-4660_3b1951e6-dd62-478f-872c-0ed6de227620 11822-4660 HUMAN OTC DRUG PURE SPRING STRAWBERRY AND POMEGRANATE ETHYL ALCOHOL LIQUID TOPICAL 20120319 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION ALCOHOL 62 mL/100mL N 20181231 11822-4670_b0b21a3d-876a-41f1-917d-29c1694640a7 11822-4670 HUMAN OTC DRUG PURE SPRING LEMON AND MINT ETHYL ALCOHOL LIQUID TOPICAL 20120319 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION ALCOHOL 62 mL/100mL N 20181231 11822-4703_0cff2c75-7397-4b52-a7d1-fc7769154d7d 11822-4703 HUMAN OTC DRUG multi-symptom cold relief Daytime, Nighttime acetaminophen, chlorpheniramine maleate, dextromethorphan HBr, phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 Rite Aid Corporation N 20181231 11822-4727_24cd4252-5de7-4a8b-9438-17f2efcf413d 11822-4727 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20170626 ANDA ANDA200172 Rite Aid Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 11822-4803_9ac7058d-96bd-41c5-9db9-181b66432370 11822-4803 HUMAN OTC DRUG RITE AID RENEWAL WITH MOISTURIZERS ETHYL ALCOHOL LIQUID TOPICAL 20120318 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION ALCOHOL 700 mg/mL N 20181231 11822-4813_e9ac92d0-0d32-4fb4-80bd-ecabe21c8d8d 11822-4813 HUMAN OTC DRUG Daylogic Advanced Hand Sanitizer Refill Ethyl Alcohol GEL TOPICAL 20170427 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation ALCOHOL 700 mg/mL N 20181231 11822-4973_614cdb3a-13a6-59cf-e781-6680783842de 11822-4973 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150514 NDA NDA020076 Rite Aid Corporation NICOTINE 7 mg/24h N 20181231 11822-4974_614cdb3a-13a6-59cf-e781-6680783842de 11822-4974 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150514 NDA NDA020076 Rite Aid Corporation NICOTINE 14 mg/24h N 20181231 11822-4975_614cdb3a-13a6-59cf-e781-6680783842de 11822-4975 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150514 NDA NDA020076 Rite Aid Corporation NICOTINE 21 mg/24h N 20181231 11822-5000_55f73226-2099-4d91-496e-60385d29c599 11822-5000 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160314 ANDA ANDA208150 Rite Aid Corporation FLUTICASONE PROPIONATE 50 ug/1 N 20181231 11822-5001_3682aef8-6518-753f-062b-795f690e4123 11822-5001 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160918 ANDA ANDA208150 Rite Aid FLUTICASONE PROPIONATE 50 ug/1 N 20181231 11822-5020_2c7f8a0f-0635-40db-b6c8-b8c53f157005 11822-5020 HUMAN OTC DRUG Rite Aid Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20130603 OTC MONOGRAPH NOT FINAL part356 Rite Aid SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 11822-5022_4d4717ec-ceb8-4500-8906-91138a8faa07 11822-5022 HUMAN OTC DRUG Sinus Pressure and Pain PE Maximum Strength Acetaminophen and Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 11822-5030_86599f4a-f78c-423e-b1d1-15e19f1d1adc 11822-5030 HUMAN OTC DRUG cold relief severe, multi-symptom acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 11822-5031_af34eed7-5c72-4e34-9923-e2f9900f8cfd 11822-5031 HUMAN OTC DRUG Cold and Flu Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 11822-5047_ea78395b-e7e9-422f-be74-97b6391165ed 11822-5047 HUMAN OTC DRUG Childrens Plus Multi Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride SUSPENSION ORAL 20150630 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 11822-5156_3ea9112f-7de0-4876-a45b-7e4696a586f8 11822-5156 HUMAN OTC DRUG Alcohol Isopropyl alcohol SWAB TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 11822-5160_8d18fc83-85be-4331-935d-0168c0d185fa 11822-5160 HUMAN OTC DRUG severe sinus congestion relief Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140630 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 11822-5161_3a7dbdef-7ea2-4b64-8e69-96e37514486c 11822-5161 HUMAN OTC DRUG Renewal Hydrating Healing Petrolatum OINTMENT TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Rite Aid PETROLATUM 41 g/100g N 20181231 11822-5211_490b18e8-f5c2-44ee-9c89-8c07d49fd6c2 11822-5211 HUMAN OTC DRUG Rite Aid PETROLATUM CREAM TOPICAL 20160501 OTC MONOGRAPH FINAL part347 Rite Aid Corporation PETROLATUM 41 g/100g N 20181231 11822-5250_3902e5d1-e643-4e82-9c6c-d0c6507a8177 11822-5250 HUMAN OTC DRUG cold and allergy relief Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20020722 20181110 OTC MONOGRAPH FINAL part341 Rite Aid CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 E 20171231 11822-5260_dc1bb26f-8fae-451f-b431-29bc4a672ba9 11822-5260 HUMAN OTC DRUG severe cold and sinus relief PE Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED ORAL 20050621 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 11822-5311_bf5fb20b-08d8-4f14-b44e-9a7dfb80f17c 11822-5311 HUMAN OTC DRUG Extra Strength pain relief Acetaminophen TABLET, FILM COATED ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 500 mg/1 N 20181231 11822-5330_f5ba5e80-e133-4731-9c5b-a9925476f611 11822-5330 HUMAN OTC DRUG Mucus Relief Cough and Congestion DM Guaifenesin and Dextromethorphan HBr TABLET, COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 11822-5334_f5de129f-7994-427c-b85e-083989e93a2f 11822-5334 HUMAN OTC DRUG Rite Aid Oral Pain Reliever Benzocaine LIQUID ORAL 20130801 OTC MONOGRAPH FINAL part333B Rite Aid BENZOCAINE 20 g/100g N 20181231 11822-5340_73013a3e-1e42-4b7e-9e07-f48ad26dfefa 11822-5340 HUMAN OTC DRUG Rite Aid Professional Strength Benzocaine LIQUID ORAL 20140101 OTC MONOGRAPH FINAL part333B Rite Aid BENZOCAINE 20 g/100g N 20181231 11822-5458_ac81ca1f-9c8a-4f77-ba49-9c139bbfb048 11822-5458 HUMAN OTC DRUG Sodium Chloride Sodium Chloride SOLUTION/ DROPS OPHTHALMIC 20130221 OTC MONOGRAPH FINAL part349 Rite Aid Corporation SODIUM CHLORIDE 50 mg/mL N 20181231 11822-5567_55fcc63e-3e93-4908-9e3a-c17782b40559 11822-5567 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20131226 OTC MONOGRAPH FINAL part355 Rite Aid SODIUM FLUORIDE .1 mg/mL N 20181231 11822-5648_60e69586-86a8-4640-a5e1-f1de80e16439 11822-5648 HUMAN OTC DRUG Rite Aid Extra Strength Pain Relief Cold and Hot Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Rite Aid MENTHOL 750 mg/1 N 20181231 11822-5649_2e636405-0db7-4985-8774-eef63369667e 11822-5649 HUMAN OTC DRUG Rite Aid Extra Strength Pain Relief Cold and Hot Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Rite Aid MENTHOL 750 mg/1 N 20181231 11822-5742_60c935d9-15b6-1457-e053-2a91aa0aec23 11822-5742 HUMAN OTC DRUG MAXIMUM STRENGTH ANTACID AND ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part331 RITE AID PHARMACY ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 11822-5744_3953ad5a-6712-4377-9af0-2a6358790909 11822-5744 HUMAN OTC DRUG RITE AID CAPSICUM HOT CAPSAICIN PATCH TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part348 RITE AID CORPORATION CAPSAICIN .6 mg/1 N 20181231 11822-5826_4baf9374-6e29-4d75-81e6-f6df8ba36243 11822-5826 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090513 OTC MONOGRAPH NOT FINAL part333A Rite Aid ISOPROPYL ALCOHOL .91 mg/mL N 20181231 11822-5829_3a565a05-67c5-4092-bf98-7e798a3c211c 11822-5829 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20150209 OTC MONOGRAPH NOT FINAL part356 Rite Aid EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11822-5927_1e16972c-38a0-4403-9241-e12a4ff7ecb5 11822-5927 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20090513 OTC MONOGRAPH FINAL part355 Rite Aid SODIUM FLUORIDE .1 mg/mL N 20181231 11822-6000_4b3e3509-2c5a-f44c-8dce-5f767f3a9a3c 11822-6000 HUMAN OTC DRUG Budesonide Budesonide SPRAY, METERED NASAL 20160713 ANDA ANDA078949 Rite Aid BUDESONIDE 32 ug/1 N 20181231 11822-6010_78429032-6cde-4e0a-99c4-e46eae1bab36 11822-6010 HUMAN OTC DRUG RITE AID DAILY MOISTURIZER SPF 15 AVOBENZONE LOTION TOPICAL 20100804 OTC MONOGRAPH FINAL part352 Rite Aid Corporation AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 2 mL/100mL; mL/100mL; mL/100mL N 20181231 11822-6020_dc2b802d-7583-47ee-96ec-b505c8185c6e 11822-6020 HUMAN OTC DRUG Rite Aid Enamel Guard Fluoride PASTE, DENTIFRICE DENTAL 20130603 OTC MONOGRAPH NOT FINAL part356 Rite Aid SODIUM FLUORIDE; POTASSIUM NITRITE .15; 5 g/100g; g/100g N 20181231 11822-6030_129aaffe-a682-466a-965d-1fabd55d7532 11822-6030 HUMAN OTC DRUG Rite Aid Maximum Strength Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B Rite Aid BENZOCAINE 20 g/100g N 20181231 11822-6051_24cd4252-5de7-4a8b-9438-17f2efcf413d 11822-6051 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20170626 ANDA ANDA200172 Rite Aid Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 11822-6052_24cd4252-5de7-4a8b-9438-17f2efcf413d 11822-6052 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20170626 ANDA ANDA200172 Rite Aid Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 11822-6053_02267eb9-aa23-9df5-620f-78872fbe1407 11822-6053 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170525 ANDA ANDA078317 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 11822-6059_02267eb9-aa23-9df5-620f-78872fbe1407 11822-6059 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170525 ANDA ANDA078317 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 11822-6101_1917fd42-dd64-4a68-b321-b673641ba13e 11822-6101 HUMAN OTC DRUG Rite Aid MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20100929 OTC MONOGRAPH FINAL part358H Rite Aid Corporation SELENIUM SULFIDE 1 mL/100mL N 20181231 11822-6107_61cd0a5b-63a6-3b9d-3519-874f061d32f6 11822-6107 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20170630 ANDA ANDA200172 Rite Aid Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20191231 11822-6111_116402f7-4b54-4c22-8a44-159b613bb9f7 11822-6111 HUMAN OTC DRUG Rite Aid Moisturizing Dandruff Medicated Formula Selenium Sulfide SHAMPOO TOPICAL 20120320 OTC MONOGRAPH FINAL part358H Rite Aid Corporation SELENIUM SULFIDE 1 mL/100mL N 20181231 11822-6150_2b069781-f3a6-4afa-a0db-393a2d0605de 11822-6150 HUMAN OTC DRUG Mucus Relief Cold and SInus Max Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET ORAL 20130630 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 11822-6160_f523cae4-53a9-4be6-b7a0-05e1747a72dd 11822-6160 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Max Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 11822-6181_506b2f61-d636-4e6d-825f-1c642a588ae0 11822-6181 HUMAN OTC DRUG Daylogic Maximum Strength Dandruff Selenium Sulfide LIQUID TOPICAL 20160209 OTC MONOGRAPH FINAL part358H RITE AID CORPORATION SELENIUM SULFIDE 10 mg/mL N 20181231 11822-6181_5a0c253c-a39f-46e0-a7be-65bec449a4a3 11822-6181 HUMAN OTC DRUG RITE AID RENEWAL CLINICAL SELENIUM SULFIDE LIQUID TOPICAL 20130326 OTC MONOGRAPH FINAL part358H RITE AID CORPORATION SELENIUM SULFIDE 10 mg/mL N 20181231 11822-6190_28e38603-36bf-46e4-aaad-ced7991d3146 11822-6190 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130615 20180715 ANDA ANDA200536 Rite Aid RANITIDINE HYDROCHLORIDE 75 mg/1 E 20171231 11822-6191_6df4f5c4-aef7-4a5b-9913-cf903542621b 11822-6191 HUMAN OTC DRUG RENEWAL MEDICATED SELENIUM SULFIDE LIQUID TOPICAL 20140113 OTC MONOGRAPH FINAL part358H RITE AID CORPORATION SELENIUM SULFIDE 10 mg/mL N 20181231 11822-6201_344d4216-82a8-4e87-adde-d2972cc481e9 11822-6201 HUMAN OTC DRUG RITE AID RENEWAL MEDICATED SELENIUM SULFIDE LIQUID TOPICAL 20130715 OTC MONOGRAPH FINAL part358H RITE AID CORPORATION SELENIUM SULFIDE 10 mg/mL N 20181231 11822-6211_ff89aadc-d3ad-4982-9f21-6d1b6472eec3 11822-6211 HUMAN OTC DRUG RITE AID RENEWAL SELENIUM SULFIDE LIQUID TOPICAL 20130620 OTC MONOGRAPH FINAL part358H RITE AID CORPORATION SELENIUM SULFIDE 10 mg/mL N 20181231 11822-6221_bc4fe34a-bd5e-4983-a681-a62e68581259 11822-6221 HUMAN OTC DRUG RENEWAL DANDRUFF MOISTURIZING SELENIUM SULFIDE LIQUID TOPICAL 20150303 OTC MONOGRAPH FINAL part358H RITE AID CORPORATION SELENIUM SULFIDE 10 mg/mL N 20181231 11822-6229_60b8a5ce-7ed6-6afa-e053-2a91aa0a98c4 11822-6229 HUMAN OTC DRUG MAXIMUM STRENGTH ANTACID AND ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part331 RITE AID PHARMACY ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 11822-6280_47fc4e29-2614-4158-9ded-2e66d91921fb 11822-6280 HUMAN OTC DRUG sinus pressure and pain maximum strength acetaminophen, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20130503 20190708 OTC MONOGRAPH FINAL part341 Rite Aid Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 E 20171231 11822-6415_f75a7234-ebd6-695f-42e0-9731346c4800 11822-6415 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160930 OTC MONOGRAPH FINAL part341 Rite Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 11822-6450_5e0d3664-b01c-ba28-e053-2991aa0a8a4c 11822-6450 HUMAN OTC DRUG Rite Aid Decolorized Iodine Ethyl Alcohol LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation ALCOHOL .45 mL/mL N 20181231 11822-6451_bb48b91a-a056-4018-ba5c-ea8ac8c5c974 11822-6451 HUMAN OTC DRUG pain relief aspirin Low Dose Aspirin TABLET, COATED ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ASPIRIN 81 mg/1 N 20181231 11822-6485_be0d345d-cc67-4100-a332-3c14c0156f38 11822-6485 HUMAN OTC DRUG severe congestion and cough/ cold and flu daytime/nighttime dextromethorphan HBr, guaifenesin, phenylephrine HCl, acetaminophen, diphenhydramine HCl KIT 20150720 OTC MONOGRAPH FINAL part341 Rite Aid Corporation N 20181231 11822-6489_e12830bc-4d5c-4859-b425-383f8f58ebc6 11822-6489 HUMAN OTC DRUG severe congestion and cough, cold and flu daytime and nighttime acetaminophen, dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl KIT 20150720 OTC MONOGRAPH FINAL part341 Rite Aid Corporation N 20181231 11822-6790_814c0cc1-0d9a-47f4-88c7-1829e9fd011d 11822-6790 HUMAN OTC DRUG menstrual pain relief maximum strength acetaminophen, pamabrom, pyrilamine maleate TABLET, FILM COATED ORAL 20150103 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 11822-6862_5d8febce-3f96-0275-e053-2991aa0a58f8 11822-6862 HUMAN OTC DRUG EXTRA STRENGTH HEARTBURN RELIEF ANTACID aluminum hydroxide and magnesium carbonate SUSPENSION ORAL 20161201 OTC MONOGRAPH FINAL part331 RITE AID PHARMACY ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 254; 237.5 mg/5mL; mg/5mL N 20181231 11822-6877_d082bcc2-f773-43db-a7c9-1a3d69ec393c 11822-6877 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20171204 OTC MONOGRAPH FINAL part355 Rite Aid SODIUM FLUORIDE .2 mg/mL N 20181231 11822-7001_b08fc5ab-7d69-4c3e-a2a4-3ce4657a00e0 11822-7001 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20111014 OTC MONOGRAPH FINAL part333D Rite Aid SALICYLIC ACID 19.8 mg/g N 20181231 11822-7053_02267eb9-aa23-9df5-620f-78872fbe1407 11822-7053 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170525 ANDA ANDA078317 Rite Aid Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 11822-7156_2dc50fa1-e0ef-4ae0-bc3c-d40c5f61cf09 11822-7156 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20170905 NDA NDA021620 Rite-Aid GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 11822-7200_b55a01bb-f9f6-41be-8e02-9dac2a8c8040 11822-7200 HUMAN OTC DRUG Rite Aid Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .115 mL/100mL N 20181231 11822-7206_949a4330-515d-4f90-889d-3681e199d0d3 11822-7206 HUMAN OTC DRUG Rite Aid Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .115 mL/100mL N 20181231 11822-7208_d76245a5-9e4c-43fb-a3e8-480b32b2a732 11822-7208 HUMAN OTC DRUG RITE AID TRICLOSAN LIQUID TOPICAL 20120221 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN .115 mL/100mL N 20181231 11822-7250_4dbc9bc1-f8f7-4abb-9d3e-d8e5dcc48468 11822-7250 HUMAN OTC DRUG Childrens Allergy Relief Fexofenadine Hydrochloride SUSPENSION ORAL 20141219 ANDA ANDA203330 Rite Aid FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 11822-7310_9e6d74cc-9f22-4fb7-bce0-dfedc18796fc 11822-7310 HUMAN OTC DRUG Miconazole 3 Combination Pack Miconazole Nitrate KIT 20010301 ANDA ANDA074926 Rite Aid N 20181231 11822-7463_fca5b078-8c59-4b66-802a-101dcb3c160f 11822-7463 HUMAN OTC DRUG Alcohol Isopropyl alcohol SWAB TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 11822-7701_fc97c099-208d-4448-a1bd-0d6d88571f0e 11822-7701 HUMAN OTC DRUG Acne Treatment Benzoyl peroxide GEL TOPICAL 20111202 OTC MONOGRAPH FINAL part333D Rite Aid BENZOYL PEROXIDE 1 mg/g N 20181231 11822-7777_f879a43d-90f4-48c3-9cf8-946db0b6637e 11822-7777 HUMAN OTC DRUG MAXIMUM STRENGTH MEDICATED ANTI-ITCH Rite Aid Menthol 1 % Pramoxine Hydrochloride 1 % CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part348 Rite Aid MENTHOL; PRAMOXINE HYDROCHLORIDE 1; 1 g/100g; g/100g N 20181231 11822-7778_9a953d37-9d91-4d64-a1c4-40418dc26331 11822-7778 HUMAN OTC DRUG Ulimate Sheer SPF 85 Rite Aid Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 10.00% Oxybenzone 6.00% SPRAY TOPICAL 20130221 OTC MONOGRAPH NOT FINAL part352 Rite Aid AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-8010_663a3218-8034-47d2-9f5d-e3deb093f0e7 11822-8010 HUMAN OTC DRUG RITE AID RENEWAL ANTIBACTERIAL CLEAR SPRING TRICLOSAN LIQUID TOPICAL 20120925 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 1.5 mg/mL N 20181231 11822-8011_d342c1a7-1353-45c8-83e3-b5ad875aea0d 11822-8011 HUMAN OTC DRUG Body Wash Clear Spring Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation TRICLOSAN .15 mL/100mL N 20181231 11822-8071_b510a182-c672-46dd-aa93-5171c3344df5 11822-8071 HUMAN OTC DRUG RITE AID RENEWAL CLEAR SPRING TRICLOSAN LIQUID TOPICAL 20130702 OTC MONOGRAPH NOT FINAL part333E RITE AID CORPORATION TRICLOSAN 1.5 mg/mL N 20181231 11822-8099_40682755-05eb-49b2-b836-65de37361860 11822-8099 HUMAN OTC DRUG Rite Aid Eye Care Lubricant Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20170518 OTC MONOGRAPH FINAL part349 Rite Aid Corporation POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 11822-8151_481543ab-6558-441a-adb3-89ed0500e08e 11822-8151 HUMAN OTC DRUG Daylogic Refreshing Body Wash Benzalkonium Chloride LIQUID TOPICAL 20160807 OTC MONOGRAPH NOT FINAL part333E Rite Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 11822-8157_2dc50fa1-e0ef-4ae0-bc3c-d40c5f61cf09 11822-8157 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20170905 NDA NDA021620 Rite-Aid GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 11822-8200_b4339c3f-c0db-4d06-9e3d-30b0be59834a 11822-8200 HUMAN OTC DRUG RENEWAL SALICYLIC ACID CREAM TOPICAL 20110728 OTC MONOGRAPH FINAL part333D RITE AID CORPORATION SALICYLIC ACID 2 mL/100mL N 20181231 11822-8210_6860f233-ca92-4867-a484-3b854ba92a45 11822-8210 HUMAN OTC DRUG RITE AID RENEWAL SALICYLIC ACID CREAM TOPICAL 20110803 OTC MONOGRAPH FINAL part333D RITE AID CORPORATION SALICYLIC ACID 2 mL/100mL N 20181231 11822-8220_90c3b346-add8-4e8d-9d74-9208379081c5 11822-8220 HUMAN OTC DRUG Antibiotic Plus Pain Relief Maximum Strength Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride CREAM TOPICAL 20061002 20180307 OTC MONOGRAPH NOT FINAL part347 Rite Aid NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g N 20181231 11822-8270_b7fe9bdd-4111-42f3-b1e2-0de3a28f409b 11822-8270 HUMAN OTC DRUG RITE AID RENEWAL ACNE SALICYLIC ACID LIQUID TOPICAL 20120607 OTC MONOGRAPH FINAL part333D RITE AID SALICYLIC ACID 2 mL/100mL N 20181231 11822-8271_a8272cdf-665e-4e94-87b6-2a128b950510 11822-8271 HUMAN OTC DRUG Quick Relief Creamy Diaper Rash Zinc Oxide CREAM TOPICAL 20140305 OTC MONOGRAPH FINAL part347 Rite Aid Corporation ZINC OXIDE 13 g/100g N 20181231 11822-8453_aee02c3a-3bdc-47cf-a3f4-b86f5408b82c 11822-8453 HUMAN OTC DRUG Rite Aid Renewal Gold Deodorant Triclocarban SOAP TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333A Rite Aid Corporation TRICLOCARBAN .3 g/g E 20171231 11822-8787_8390c1ec-6a5e-4fed-b774-7f2654dc56a3 11822-8787 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130828 OTC MONOGRAPH NOT FINAL part356 Rite Aid EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 11822-9000_82805791-9260-470e-b5f5-cd55c8145338 11822-9000 HUMAN OTC DRUG Rite Aid Sport SunscreenSPF 30 SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9001_e14cf041-7cbc-45e4-bf14-2888078edad5 11822-9001 HUMAN OTC DRUG Rite Aid Sport SunscreenSPF 50 SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9002_1c674517-16f4-4a90-90e3-a569d882acc3 11822-9002 HUMAN OTC DRUG Rite Aid Ear Drops Chamomilla and Mercurius solubilis and Sulphur SOLUTION AURICULAR (OTIC) 20060101 UNAPPROVED HOMEOPATHIC Rite Aid Corporation CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR 10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 11822-9003_965186b9-706c-4e7b-bfbe-d3d70cc36d16 11822-9003 HUMAN OTC DRUG Rite Aid Oil Free Faces Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 8; 5; 5; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9004_9e4000c0-f6b5-4cc0-9ba1-3b8d2017b1aa 11822-9004 HUMAN OTC DRUG Rite Aid Essential Defense SPF 45 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTINOXATE; OXYBENZONE 2; 12; 5; 7.5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9005_b34d203b-cfe3-4113-8f35-4f0a8d26cf61 11822-9005 HUMAN OTC DRUG Rite Aid Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9006_3041da46-b8ea-40f3-81e8-c55a51eb772b 11822-9006 HUMAN OTC DRUG Rite Aid Dark Tanning SPF 4 OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION OCTOCRYLENE; OXYBENZONE 1; .5 g/100g; g/100g N 20181231 11822-9007_17de2183-c966-42c5-99ad-2f8a82e9521f 11822-9007 HUMAN OTC DRUG Rite Aid Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9008_d39b177f-ef26-4ada-9531-1db9272df8d8 11822-9008 HUMAN OTC DRUG Rite Aid Kids Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE SPRAY TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9009_df855d59-886e-4d63-a749-a94d8279b610 11822-9009 HUMAN OTC DRUG Rite Aid Burn Relief LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part348 RITE AID CORPORATION LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 11822-9010_870c8bee-fc44-48c6-b397-886194d11fa2 11822-9010 HUMAN OTC DRUG Rite Aid Baby Sunscreen AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9011_b0f7005b-6635-4c7a-bf25-41ac35393f2f 11822-9011 HUMAN OTC DRUG Rite Aid Sunscreen AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9012_93cb5423-b074-42d2-a425-f8390d2e258c 11822-9012 HUMAN OTC DRUG Rite Aid Ultimate Sheer AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9013_77e38e12-fa60-4f08-b2e4-95733794ac09 11822-9013 HUMAN OTC DRUG Rite Aid Ultimate Sheer AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9014_8939cd6b-5f18-44dd-9429-b130d196add0 11822-9014 HUMAN OTC DRUG Rite Aid Sunscreen OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20121205 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 6 g/100g; g/100g; g/100g N 20181231 11822-9015_5463dfe3-8865-4e03-a0e9-09a8f82e47db 11822-9015 HUMAN OTC DRUG Rite Aid Sport Sunscreen AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121207 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 8; 4 g/100g; g/100g; g/100g N 20181231 11822-9016_f76595c9-9fe1-45f3-aa83-d91884e11c88 11822-9016 HUMAN OTC DRUG Rite Aid Ultimate Sheer AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 4.5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9017_c2c25ee8-8c96-4648-b1ef-58c9325b956a 11822-9017 HUMAN OTC DRUG Rite Aid RENEWAL Sport SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9018_a788a651-540b-4ad7-bbc5-298ce688d862 11822-9018 HUMAN OTC DRUG Rite Aid RENEWALSPF 50 SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9019_adebfb64-7a9f-414f-b551-ce38e5bcf7fe 11822-9019 HUMAN OTC DRUG Rite Aid RENEWAL oil free faces AVOBENZONE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; OXYBENZONE; OCTOCRYLENE 2; 3; 5 g/100g; g/100g; g/100g N 20181231 11822-9020_0c864434-31c6-4e4a-accc-e6717c3b0f9a 11822-9020 HUMAN OTC DRUG Rite Aid RENEWAL essential defense SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9021_c240aff0-5ec3-4f40-a722-174b69c48fe0 11822-9021 HUMAN OTC DRUG Rite Aid RENEWAL SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g N 20181231 11822-9022_01a9a5e5-b1e8-4c5c-988c-6852dc0f80ca 11822-9022 HUMAN OTC DRUG Rite Aid RENEWAL kids SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 11822-9023_89451c8d-0e06-468b-9d20-4c4ba6cc2b27 11822-9023 HUMAN OTC DRUG Rite Aid RENEWAL SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g N 20181231 11822-9024_2861d2a3-81cc-4a04-8518-bc9983451ce6 11822-9024 HUMAN OTC DRUG Rite Aid SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part352 Rite Aid AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3; 10; 6 g/100g; g/100g; g/100g N 20181231 11822-9025_3cb7dcd4-9619-4a5d-bcf2-b6cd896e69eb 11822-9025 HUMAN OTC DRUG Rite Aid RENEWAL SPF 30 AVOBENZONE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; OXYBENZONE; OCTOCRYLENE 2; 3; 5 g/100g; g/100g; g/100g N 20181231 11822-9026_ef641492-b860-4175-8536-5fdd0ae3e940 11822-9026 HUMAN OTC DRUG Rite Aid RENEWAL SPF 50 AVOBENZONE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION AVOBENZONE; OXYBENZONE; OCTOCRYLENE 3; 6; 4 g/100g; g/100g; g/100g N 20181231 11822-9027_37c20b60-857c-4337-925f-d890795f6ffb 11822-9027 HUMAN OTC DRUG Rite Aid RENEWAL baby sunscreen SPF 60 TITANIUM DIOXIDE ZINC OXIDE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 RITE AID CORPORATION TITANIUM DIOXIDE; ZINC OXIDE 2.8; 4 g/100g; g/100g N 20181231 11822-9028_7f7ab6e8-9956-4245-9f1f-b224e7119d73 11822-9028 HUMAN OTC DRUG Rite Aid SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20160531 OTC MONOGRAPH NOT FINAL part352 Rite Aid AVOBENZONE; HOMOSALATE; OCTOCRYLENE 1.8; 7; 5 g/100g; g/100g; g/100g N 20181231 11822-9202_e1187b44-abd6-4a15-81c4-13138e331bf1 11822-9202 HUMAN OTC DRUG RITE AID SPF 30 Avobenzone, Homosalate, Octisalate,Octocrylene LOTION TOPICAL 20160303 OTC MONOGRAPH NOT FINAL part352 Rite Aid AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g N 20181231 11822-9271_69660bdd-6a57-40e9-9dfd-d4ea6020b9a0 11822-9271 HUMAN OTC DRUG Maximum Strength Original Diaper Rash Zinc Oxide CREAM TOPICAL 20140305 OTC MONOGRAPH FINAL part347 Rite Aid Corporation ZINC OXIDE 40 g/100g N 20181231 11822-9440_71b0f707-ff5b-4d73-acf5-bc8de677723b 11822-9440 HUMAN OTC DRUG pain reliefs childrens acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Rite Aid Corporation ACETAMINOPHEN 160 mg/1 N 20181231 11822-9643_24adf15c-670c-64a7-e054-00144ff88e88 11822-9643 HUMAN OTC DRUG Rite Aid Menthol LOZENGE ORAL 20110701 OTC MONOGRAPH FINAL part341 Rite Aid MENTHOL 5.8 mg/1 N 20181231 11822-9650_61305f4e-6dc2-7b4f-e053-2a91aa0a64e2 11822-9650 HUMAN OTC DRUG RIte Aid Maximum Strength Foot Care Anti-fungal Pen Undecylenic Acid LIQUID TOPICAL 20131210 OTC MONOGRAPH FINAL part333C Rite Aid UNDECYLENIC ACID 250 mg/mL N 20181231 11822-9785_40701bec-d348-446d-be4f-728ed3981f8b 11822-9785 HUMAN OTC DRUG Advanced Firming and Anti Wrinkle Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120517 OTC MONOGRAPH NOT FINAL part352 Rite Aid Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g N 20181231 11822-9854_48cef92e-4cbc-4b79-a7fe-1f071945cc9c 11822-9854 HUMAN OTC DRUG Artifical Tears Glycerin and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Rite Aid Corporation GLYCERIN; PROPYLENE GLYCOL .3; 1 g/100mL; g/100mL N 20181231 11822-9860_b0114d22-a48d-4c6c-b384-aeecfd4d8bb7 11822-9860 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Rite Aid Corporation WATER 99.05 mL/100mL N 20181231 11822-9972_1b11e2c5-9653-4bc8-9023-9f107ed4d1ea 11822-9972 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20160502 OTC MONOGRAPH FINAL part358H Rite Aid COAL TAR 1.02 mg/mL N 20181231 11822-9973_7d324811-5d01-4616-a4c7-1267763ef4d9 11822-9973 HUMAN OTC DRUG Therapeutic Dandruff Coal Tar SHAMPOO TOPICAL 20090513 OTC MONOGRAPH FINAL part358H Rite Aid COAL TAR 25 mg/mL N 20181231 11822-9974_3696a19d-1f94-506f-e054-00144ff88e88 11822-9974 HUMAN OTC DRUG Rite Aid Original Strength Vagicaine BENZOCAINE and RESORCINOL CREAM TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part348 Rite Aid Corporation BENZOCAINE; RESORCINOL 5; 2 g/100g; g/100g N 20181231 11853-013_5f74ddf1-3a9c-404d-a307-007a0c3cf279 11853-013 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205737 Air Liquide Large Industries U.S. LP OXYGEN 99 L/100L N 20181231 11853-023_56908ccf-d2e2-4846-bf9e-faf84fb5e3d1 11853-023 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205738 Air Liquide Large Industries U.S. LP NITROGEN 99 L/100L N 20181231 11856-0001_2205bf29-d23d-4ec2-e054-00144ff88e88 11856-0001 HUMAN OTC DRUG Goyescas 7 Syrups Original Cough and Cold Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 19580801 OTC MONOGRAPH FINAL part341 GOYESCAS OF FLA DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 50; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 11856-0016_227cde7b-bd97-27aa-e054-00144ff8d46c 11856-0016 HUMAN OTC DRUG Goyescas Broncovac 1 Cough and Cold Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 19580801 OTC MONOGRAPH FINAL part341 GOYESCAS OF FLA PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 10; 50 mg/5mL; mg/5mL; mg/5mL E 20171231 11856-0017_227d08d5-cade-7118-e054-00144ff88e88 11856-0017 HUMAN OTC DRUG Goyescas Broncovac 2 Cough and Cold Dextromethorphan, Guafenesin, Phenylephrine LIQUID ORAL 20061001 OTC MONOGRAPH FINAL part341 GOYESCAS OF FLA PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 5; 100; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 11856-0025_227d52d3-7001-05b6-e054-00144ff88e88 11856-0025 HUMAN OTC DRUG Goyescas Broncovac 3 Cough and Cold Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20061001 OTC MONOGRAPH FINAL part341 GOYESCAS OF FLA GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 100; 5; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 11856-0026_227ca1a6-3bb6-678b-e054-00144ff88e88 11856-0026 HUMAN OTC DRUG Goyescas 7 Syrups with Bee Honey Cough and Cold Dextrmethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20061001 OTC MONOGRAPH FINAL part341 GOYESCAS OF FLA GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 100; 5; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 11856-0031_227c1f1f-2fd7-547e-e054-00144ff88e88 11856-0031 HUMAN OTC DRUG Goyescas 7 Syrups Alcohol and Sugar Free Cough and Cold Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20061001 OTC MONOGRAPH FINAL part341 GOYESCAS OF FLA GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 100; 5; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 11856-3365_227d9ccb-8783-0f69-e054-00144ff88e88 11856-3365 HUMAN OTC DRUG Pinceladas Goyescas Original Brush on Fungicide Undecylenic Acid LIQUID TOPICAL 19580801 OTC MONOGRAPH FINAL part333C GOYESCAS OF FLA UNDECYLENIC ACID 100 mg/mL E 20171231 11856-3367_227d7f53-d9d4-4298-e054-00144ff8d46c 11856-3367 HUMAN OTC DRUG Pinceladas Goyescas Original Fungicide Undecylenic Acid LIQUID TOPICAL 19580801 OTC MONOGRAPH FINAL part333C GOYESCAS OF FLA UNDECYLENIC ACID 100 mg/mL E 20171231 11856-5001_227e7e75-3e7f-5ec3-e054-00144ff8d46c 11856-5001 HUMAN OTC DRUG Tokisan Sore Throat Relief Benzocaine LIQUID ORAL 19580801 OTC MONOGRAPH FINAL part346 GOYESCAS OF FLA BENZOCAINE 50 mg/mL E 20171231 11856-5002_227e9b92-dbaf-2178-e054-00144ff88e88 11856-5002 HUMAN OTC DRUG Goyescas Broncovac 5 Sore Throat Relief Benzocaine LIQUID ORAL 20061001 OTC MONOGRAPH FINAL part346 GOYESCAS OF FLA BENZOCAINE 50 mg/mL E 20171231 11856-5003_227e9b92-dbb1-2178-e054-00144ff88e88 11856-5003 HUMAN OTC DRUG Goyescas 7 Syrups Sore Throat Relief Benzocaine LIQUID ORAL 20151001 OTC MONOGRAPH FINAL part346 GOYESCAS OF FLA BENZOCAINE 50 mg/mL E 20171231 11868-311_020a55f0-bcb2-4193-9a4c-a993fa54d9e2 11868-311 HUMAN OTC DRUG Cold Preparation Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 New Genesis/Monticello Drug LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 11868-390_db8319e2-0939-4b4d-85e9-ec9d96214865 11868-390 HUMAN OTC DRUG Tronolane Pramoxine HCl CREAM TOPICAL 20111204 OTC MONOGRAPH FINAL part347 New Genesis/Monticello Drug LLC PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 10; 50 mg/g; mg/g N 20191231 11868-466_b7be7dc8-26c1-46c1-92d4-674cb42418c3 11868-466 HUMAN OTC DRUG Cold Preparation For Cough and Sinus Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 New Genesis/Monticello Drug LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 11896-0017_b1216615-78a2-4377-add6-957fd7c781cc 11896-0017 HUMAN PRESCRIPTION DRUG Helium Oxygen Helium Oxygen GAS RESPIRATORY (INHALATION) 19640101 UNAPPROVED MEDICAL GAS Airgas National Welders HELIUM; OXYGEN 800; 200 mL/L; min/L E 20171231 11896-0018_51e6cf36-97ae-4d17-9372-5a3947c2e0bb 11896-0018 HUMAN PRESCRIPTION DRUG Helium Oxygen Helium Oxygen GAS RESPIRATORY (INHALATION) 19640101 UNAPPROVED MEDICAL GAS Airgas National Welders HELIUM; OXYGEN 700; 300 mL/L; mL/L E 20171231 11896-0019_e0ed0937-63ba-409e-a194-6b45ebef5ed6 11896-0019 HUMAN PRESCRIPTION DRUG Helium Oxygen Helium Oxygen GAS RESPIRATORY (INHALATION) 19640101 UNAPPROVED MEDICAL GAS Airgas National Welders HELIUM; OXYGEN 600; 400 mL/L; mL/L E 20171231 11928-004_bd5d58b9-eb45-4688-970f-17175b2b14e9 11928-004 HUMAN OTC DRUG Mada Alcohol GEL TOPICAL 20040401 OTC MONOGRAPH NOT FINAL part333E Mada Medical Products, Inc. ALCOHOL 62 mL/100mL N 20181231 11928-005_d7d50cd0-663e-42b3-8105-437456656a8b 11928-005 HUMAN OTC DRUG Mada 70% Alcohol Alcohol GEL TOPICAL 20171012 OTC MONOGRAPH NOT FINAL part333E Mada Medical Products, Inc. ALCOHOL 72 L/100L N 20191231 11928-682_a3baee18-524b-47f7-a8c3-f904793cbba5 11928-682 HUMAN OTC DRUG Mada Medical Foam Sanitizer Benzethonium Chloride LIQUID TOPICAL 20100102 OTC MONOGRAPH NOT FINAL part333A Mada Medical BENZETHONIUM CHLORIDE .2 mL/100mL E 20171231 11960-0045_ed47d536-da3d-4083-8bef-c81a1c73fabc 11960-0045 HUMAN OTC DRUG Cramergesic menthol, methyl salicylate OINTMENT TOPICAL 19920715 OTC MONOGRAPH NOT FINAL part348 Cramer Products Inc MENTHOL; METHYL SALICYLATE .019; .137 g/g; g/g E 20171231 11960-0049_c18ced39-4afc-4073-b1e7-47363df948ed 11960-0049 HUMAN OTC DRUG Nitrotan isopropyl alcohol, benzyl alcohol, picric acid, tannic acid AEROSOL, SPRAY TOPICAL 19920715 OTC MONOGRAPH NOT FINAL part333A Cramer Products Inc ISOPROPYL ALCOHOL; BENZYL ALCOHOL; PICRIC ACID; TANNIC ACID .62; .061; .002; .015 g/g; g/g; g/g; g/g E 20171231 11960-0550_8f8bc748-6344-4356-b6e2-4b6e82ce7d84 11960-0550 HUMAN OTC DRUG ISO-QUIN Alcohol GEL TOPICAL 20000614 OTC MONOGRAPH NOT FINAL part333E Cramer Products, Inc ALCOHOL .68 mL/mL E 20171231 11960-1201_500a5d33-4a33-4ddf-8ce6-123e670ae590 11960-1201 HUMAN OTC DRUG Coachs First Aid Contains 102 Pieces BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100502 OTC MONOGRAPH FINAL part333 Cramer Sports N 20181231 11980-011_329902a8-1121-4129-ba1f-5e5573f52dd5 11980-011 HUMAN PRESCRIPTION DRUG BLEPH-10 sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 19710601 ANDA ANDA080028 Allergan, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 11980-022_dbc71865-f932-4ad0-8ae5-fd0a6e86b985 11980-022 HUMAN PRESCRIPTION DRUG BLEPHAMIDE sulfacetamide sodium and prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19611001 NDA NDA012813 Allergan, Inc. SULFACETAMIDE SODIUM; PREDNISOLONE ACETATE 100; 2 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 11980-174_590a6d22-934c-431c-bb9a-681cdd37b079 11980-174 HUMAN PRESCRIPTION DRUG PRED MILD prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19721201 NDA NDA017100 Allergan, Inc. PREDNISOLONE ACETATE 1.2 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 11980-180_df110811-3f96-4d72-b90b-11a012ccc2f2 11980-180 HUMAN PRESCRIPTION DRUG PRED FORTE prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19730601 NDA NDA017011 Allergan, Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 11980-211_8642c165-e7b7-4463-b3d6-859518eb312e 11980-211 HUMAN PRESCRIPTION DRUG FML fluorometholone SUSPENSION/ DROPS OPHTHALMIC 19720201 NDA NDA016851 Allergan, Inc. FLUOROMETHOLONE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 11980-228_fedb07a1-73c2-431a-8821-1f960f9d2e2f 11980-228 HUMAN PRESCRIPTION DRUG FML FORTE fluorometholone SUSPENSION/ DROPS OPHTHALMIC 19860501 NDA NDA019216 Allergan, Inc. FLUOROMETHOLONE 2.5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 11980-779_e52b9f28-64ab-4b69-a5a9-340048b59de3 11980-779 HUMAN PRESCRIPTION DRUG OCUFLOX ofloxacin SOLUTION/ DROPS OPHTHALMIC 19930801 NDA NDA019921 Allergan, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 11980-801_476d98a3-b01f-446d-8714-fd6252fdecdb 11980-801 HUMAN PRESCRIPTION DRUG OCUFEN flurbiprofen sodium SOLUTION/ DROPS OPHTHALMIC 19870101 NDA NDA019404 Allergan, Inc. FLURBIPROFEN SODIUM .3 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 11993-001_dbc77d91-1795-45cb-95ee-f1dae0b20e9f 11993-001 HUMAN OTC DRUG ASTRAPHARM CHILLI BRAND EXTERNAL MEDICATED Capsaicin PLASTER TOPICAL 20070501 OTC MONOGRAPH NOT FINAL part348 DERSAN PHARMACEUTICAL CO LTD CAPSAICIN 70 mg/1 N 20181231 11994-001_d554bad8-499f-45ee-9efd-ea28adc946b2 11994-001 HUMAN PRESCRIPTION DRUG Cardiolite TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19901220 NDA NDA019785 Lantheus Medical Imaging, Inc. TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/mL N 20181231 11994-003_929031aa-1664-43e2-a951-a6bc5c27854b 11994-003 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc99m Sestamibi TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19901220 NDA NDA019785 Lantheus Medical Imaging, Inc. TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/mL N 20181231 11994-006_bb7e8ee8-4979-45e7-a361-2bb5f68b6a26 11994-006 HUMAN PRESCRIPTION DRUG NEUROLITE Bicisate dihydrochloride KIT INTRAVENOUS 19941123 NDA NDA020256 Lantheus Medical Imaging, Inc. N 20181231 11994-011_c93d3f05-f26b-4ca7-bfac-0f6b95b96418 11994-011 HUMAN PRESCRIPTION DRUG Definity perflutren INJECTION, SUSPENSION INTRAVENOUS 20010731 NDA NDA021064 Lantheus Medical Imaging, Inc. PERFLUTREN 6.52 mg/mL Contrast Agent for Ultrasound Imaging [EPC],Ultrasound Contrast Activity [MoA] N 20181231 11994-015_69b2d2fe-9837-4421-89c6-c4196eb28f17 11994-015 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F-18 Fludeoxyglucose F-18 INJECTION INTRAVENOUS 20140204 ANDA ANDA203664 Lantheus Medical Imaging, Inc. FLUDEOXYGLUCOSE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 11994-016_fb28f955-edfe-43b6-bdf2-04149bf0dc5a 11994-016 HUMAN PRESCRIPTION DRUG Quadramet samarium Sm 153 lexidronam INJECTION, SOLUTION INTRAVENOUS 19970519 NDA NDA020570 Lantheus Medical Imaging, Inc. SAMARIUM SM-153 LEXIDRONAM PENTASODIUM 50 mCi/mL N 20181231 11994-090_af6987ea-97a0-483f-ba02-7a7202b7da6d 11994-090 HUMAN PRESCRIPTION DRUG TechneLite Technetium Tc99m Generator INJECTION, SOLUTION INTRAVENOUS 19751101 NDA NDA017771 Lantheus Medical Imaging, Inc. TECHNETIUM TC-99M SODIUM PERTECHNETATE 250 mCi/mL N 20181231 11994-091_af6987ea-97a0-483f-ba02-7a7202b7da6d 11994-091 HUMAN PRESCRIPTION DRUG TechneLite Technetium Tc99m Generator INJECTION, SOLUTION INTRAVENOUS 19751101 NDA NDA017771 Lantheus Medical Imaging, Inc. TECHNETIUM TC-99M SODIUM PERTECHNETATE 250 mCi/mL N 20181231 11994-121_96bce1f0-1255-460e-8839-46d494411921 11994-121 HUMAN PRESCRIPTION DRUG Gallium GALLIUM CITRATE GA-67 INJECTION INTRAVENOUS 19760519 NDA NDA017478 Lantheus Medical Imaging, Inc. GALLIUM CITRATE GA-67 2 mCi/mL N 20181231 11994-127_8af3d272-e058-46fd-abad-5bbeec9ceca6 11994-127 HUMAN PRESCRIPTION DRUG Xenon Xenon XE-133 GAS RESPIRATORY (INHALATION) 19741010 NDA NDA017284 Lantheus Medical Imaging, Inc. XENON XE-133 10 mCi/1 Inhalation Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 11994-128_8af3d272-e058-46fd-abad-5bbeec9ceca6 11994-128 HUMAN PRESCRIPTION DRUG Xenon Xenon XE-133 GAS RESPIRATORY (INHALATION) 19741010 NDA NDA017284 Lantheus Medical Imaging, Inc. XENON XE-133 20 mCi/1 Inhalation Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 11994-427_d7457aff-9687-4570-a5dc-120b34bc9686 11994-427 HUMAN PRESCRIPTION DRUG Thallous Chloride Tl 201 THALLOUS CHLORIDE TL-201 INJECTION, SOLUTION INTRAVENOUS 19771219 NDA NDA017806 Lantheus Medical Imaging, Inc. THALLOUS CHLORIDE TL-201 2 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 11999-001_48e07aa6-3870-45bb-ad43-5f740f87eb77 11999-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19730101 NDA NDA205767 Welders Supply Company OXYGEN 992 mL/L N 20181231 11999-002_eb772a71-a22e-46e4-bd81-bf117f8c8ea4 11999-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19730101 UNAPPROVED MEDICAL GAS Welders Supply Company NITROGEN 990 mL/L N 20181231 12022-000_63118834-3cfe-795f-e053-2a91aa0ad67d 12022-000 HUMAN OTC DRUG Artra Skin Tone for Oily Skin Hydroquinone, Homosalate, Oxybenzone CREAM TOPICAL 19901201 OTC MONOGRAPH NOT FINAL part358A J. Strickland & Co. HYDROQUINONE; HOMOSALATE; OXYBENZONE 75; 20; 25 mg/g; mg/g; mg/g N 20191231 12022-001_63118834-3d1d-795f-e053-2a91aa0ad67d 12022-001 HUMAN OTC DRUG Artra Skin Tone for Normal Skin Hydroquinone, Homosalate, Oxybenzone CREAM TOPICAL 19901201 OTC MONOGRAPH NOT FINAL part358A J. Strickland & Co. HOMOSALATE; HYDROQUINONE; OXYBENZONE 75; 20; 25 mg/g; mg/g; mg/g N 20191231 12022-002_63118834-3d3b-795f-e053-2a91aa0ad67d 12022-002 HUMAN OTC DRUG Artra Skin Tone for Dry Skin Hydroquinone, Homosalate, Oxybenzone CREAM TOPICAL 19901201 OTC MONOGRAPH NOT FINAL part358A J. Strickland & Co. HOMOSALATE; HYDROQUINONE; OXYBENZONE 75; 20; 25 mg/g; mg/g; mg/g N 20191231 12022-003_63118834-3d49-795f-e053-2a91aa0ad67d 12022-003 HUMAN OTC DRUG Black and White Skin Bleach Hydroquinone CREAM TOPICAL 19901201 OTC MONOGRAPH NOT FINAL part358A J. Strickland & Co. HYDROQUINONE 20 mg/g N 20191231 12022-004_63118834-3d58-795f-e053-2a91aa0ad67d 12022-004 HUMAN OTC DRUG Black and White Skin Protectant Petrolatum OINTMENT TOPICAL 19901201 OTC MONOGRAPH FINAL part347 J. Strickland & Co. PETROLATUM 620 mg/g N 20191231 12022-005_63241321-195a-7b16-e053-2a91aa0a3b53 12022-005 HUMAN OTC DRUG Doo Gro Anti-Dandruff Vitalizer Pyrithione Zinc CREAM TOPICAL 20150115 OTC MONOGRAPH FINAL part358H J. Strickland & Co. DBA Nature's Protein, Inc. PYRITHIONE ZINC 1 mg/mL N 20191231 12022-007_6323fde5-7aab-73a3-e053-2a91aa0aabe3 12022-007 HUMAN OTC DRUG Glovers Dandruff Control Medicine, Regular Sulfur SUSPENSION TOPICAL 20010924 OTC MONOGRAPH FINAL part358H J. Strickland & Co. SULFUR 25 mg/mL N 20191231 12022-008_6323fde5-7ab7-73a3-e053-2a91aa0aabe3 12022-008 HUMAN OTC DRUG Glovers Dandruff Control Med., Floral Sulfur SUSPENSION TOPICAL 20011105 OTC MONOGRAPH FINAL part358H J. Strickland & Co. SULFUR 25 mg/mL N 20191231 12022-009_63241321-196b-7b16-e053-2a91aa0a3b53 12022-009 HUMAN OTC DRUG Glovers Anti-Dandruff Sulfur, Salicylic Acid OINTMENT TOPICAL 20010920 OTC MONOGRAPH FINAL part358H J. Strickland & Co. SULFUR; SALICYLIC ACID 50; 30 mg/g; mg/g N 20191231 12022-010_63241321-1978-7b16-e053-2a91aa0a3b53 12022-010 HUMAN OTC DRUG Glovers Medicated Anti-Dandruff COAL TAR SHAMPOO TOPICAL 20011031 OTC MONOGRAPH FINAL part358H J. Strickland & Co. COAL TAR 25 mg/mL N 20191231 12022-011_63241321-1985-7b16-e053-2a91aa0a3b53 12022-011 HUMAN OTC DRUG Glovers Medicated Anti-Dandruff Scalp Salicylic Acid SOLUTION TOPICAL 20011105 OTC MONOGRAPH FINAL part358H J. Strickland & Co. SALICYLIC ACID 30 mg/mL N 20191231 12022-012_6324462d-9097-6012-e053-2991aa0a24de 12022-012 HUMAN OTC DRUG Nadinola Skin Fade for Dry Skin Hydroquinone, Octisalate CREAM TOPICAL 19830601 OTC MONOGRAPH NOT FINAL part358A J. Strickland & Co. HYDROQUINONE; OCTISALATE 20; 30 mg/g; mg/g N 20191231 12022-013_6324462d-90a5-6012-e053-2991aa0a24de 12022-013 HUMAN OTC DRUG Nadinola Skin Fade for Oily Skin Hydroquinone, Octisalate CREAM TOPICAL 19830601 OTC MONOGRAPH NOT FINAL part358A J. Strickland & Co. HYDROQUINONE; OCTISALATE 20; 30 mg/g; mg/g N 20191231 12022-014_63244ba2-f452-ea2e-e053-2a91aa0a3d80 12022-014 HUMAN OTC DRUG Nadinola Skin FadeExtra Hydroquinone, Octisalate CREAM TOPICAL 19830601 OTC MONOGRAPH NOT FINAL part358A J. Strickland & Co. HYDROQUINONE; OCTISALATE 30; 30 mg/g; mg/g N 20191231 12022-015_6323d4f6-55c1-3559-e053-2991aa0a43f4 12022-015 HUMAN OTC DRUG Nadinola Skin Fade for Normal Skin Hydroquinone, Octisalate CREAM TOPICAL 19830601 OTC MONOGRAPH NOT FINAL part358A J. Strickland & Co. HYDROQUINONE; OCTISALATE 30; 30 mg/g; mg/g N 20191231 12022-016_6324462d-90c6-6012-e053-2991aa0a24de 12022-016 HUMAN OTC DRUG Othine Skin Bleach Hydroquinone, Octisalate CREAM TOPICAL 19740701 OTC MONOGRAPH NOT FINAL part358A J. Strickland & Co. HYDROQUINONE; OCTISALATE 30; 30 mg/g; mg/g N 20191231 12022-017_63245653-ea83-fcea-e053-2a91aa0a86e6 12022-017 HUMAN OTC DRUG Sulfur 8 Original Anti-Dandruff Hair and Scalp Conditioner Sulfur OINTMENT TOPICAL 19901201 OTC MONOGRAPH FINAL part358H J. Strickland & Co. SULFUR 20 mg/g N 20191231 12022-018_632411c1-a177-1226-e053-2991aa0ace7c 12022-018 HUMAN OTC DRUG Sulfur 8 Light Anti-Dandruff Hair and Scalp Conditioner Sulfur OINTMENT TOPICAL 19901201 OTC MONOGRAPH FINAL part358H J. Strickland & Co. SULFUR 20 mg/g N 20191231 12022-019_63245653-ea93-fcea-e053-2a91aa0a86e6 12022-019 HUMAN OTC DRUG Sulfur 8 Oil Moisturizer Anti-Dandruff Pyrithione Zinc LOTION TOPICAL 20051007 OTC MONOGRAPH FINAL part358H J. Strickland & Co. PYRITHIONE ZINC 1 mg/mL N 20191231 12022-020_63245653-ea9f-fcea-e053-2a91aa0a86e6 12022-020 HUMAN OTC DRUG Sulfur 8 Light Moisturizer Anti-Dandruff Pyrithione Zinc LOTION TOPICAL 19901201 OTC MONOGRAPH FINAL part358H J. Strickland & Co. PYRITHIONE ZINC 1 mg/mL N 20191231 12022-021_6324462d-90e4-6012-e053-2991aa0a24de 12022-021 HUMAN OTC DRUG Sulfur 8 Anti-Dandruff Braid Salicylic Acid SOLUTION TOPICAL 19940714 OTC MONOGRAPH FINAL part358H J. Strickland & Co. SALICYLIC ACID 20 mg/mL N 20191231 12022-022_63245653-eaac-fcea-e053-2a91aa0a86e6 12022-022 HUMAN OTC DRUG Sulur 8 Kids Anti-Dandruff Hair and Scalp Conditioner Sulfur OINTMENT TOPICAL 19970820 OTC MONOGRAPH FINAL part358H J. Strickland & Co. SULFUR 20 mg/g N 20191231 12022-023_63247203-8c5b-b0c8-e053-2991aa0a7813 12022-023 HUMAN OTC DRUG Sulfur 8 Kids Anti-Dandruff Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 19950522 OTC MONOGRAPH FINAL part358H J. Strickland & Co. PYRITHIONE ZINC 10 mg/mL N 20191231 12022-024_63248a6e-d3df-5a50-e053-2a91aa0aadcd 12022-024 HUMAN OTC DRUG Sulfur 8 Aqua Blue Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 20020715 OTC MONOGRAPH FINAL part358H J. Strickland & Co. PYRITHIONE ZINC 10 mg/mL N 20191231 12022-025_632497dc-02fa-deee-e053-2991aa0a34a0 12022-025 HUMAN OTC DRUG Sulfur 8 Loc Twist and Braid Scalp Salicylic Acid SOLUTION TOPICAL 20030519 OTC MONOGRAPH FINAL part358H J. Strickland & Co. SALICYLIC ACID 20 mg/mL N 20191231 12022-026_632497dc-0306-deee-e053-2991aa0a34a0 12022-026 HUMAN OTC DRUG Sulfur 8 Fresh Anti-Dandruff Hair and Scalp Conditioner Salicylic Acid OINTMENT TOPICAL 20080206 OTC MONOGRAPH FINAL part358H J. Strickland & Co. SALICYLIC ACID 20 mg/g N 20191231 12022-027_6324a782-d8f5-0635-e053-2a91aa0aef7e 12022-027 HUMAN OTC DRUG Sulfur 8 Fresh Anti-Dandruff Moisturizing Pyrithione Zinc CREAM TOPICAL 20080206 OTC MONOGRAPH FINAL part358H J. Strickland & Co. PYRITHIONE ZINC 1 mg/g N 20191231 12022-028_6324acc7-9296-00ed-e053-2991aa0a2017 12022-028 HUMAN OTC DRUG Sulfur 8 Fresh Anti-Dandruff Salicylic Acid SOLUTION TOPICAL 20080206 OTC MONOGRAPH FINAL part358H J. Strickland & Co. SALICYLIC ACID 20 mg/mL N 20191231 12022-029_6324acc7-92a2-00ed-e053-2991aa0a2017 12022-029 HUMAN OTC DRUG Sulfur 8 Fresh Anti-Dandruff Oil Moisturizing Pyrithione Zinc LOTION TOPICAL 20080206 OTC MONOGRAPH FINAL part358H J. Strickland & Co. PYRITHIONE ZINC 1 mg/mL N 20191231 12022-030_6324acc7-92ae-00ed-e053-2991aa0a2017 12022-030 HUMAN OTC DRUG Sulfur 8 Five Star Anti-Dandruff Hair Groom Pyrithione Zinc CREAM TOPICAL 20100429 OTC MONOGRAPH FINAL part358H J. Strickland & Co. PYRITHIONE ZINC 1 mg/g N 20191231 12022-031_6324b343-72f8-0da5-e053-2a91aa0a425f 12022-031 HUMAN OTC DRUG White Rose Petroleum Jelly Petrolatum OINTMENT TOPICAL 19380801 OTC MONOGRAPH FINAL part347 J. Strickland & Co. PETROLATUM 1000 mg/g N 20191231 12027-100_5e6388f9-b66f-422b-b90e-5529dae7c68e 12027-100 HUMAN OTC DRUG wet n wild megashield OCTINOXATE OXYBENZONE LIPSTICK TOPICAL 20111201 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 12027-101_f0e754d4-49d2-40d1-b31b-59f3eca75102 12027-101 HUMAN OTC DRUG wet n wild juicy lip balm Octinoxate Octocrylene Oxybenzone LIPSTICK TOPICAL 20111201 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc OCTINOXATE; OCTOCRYLENE; OXYBENZONE 7.5; 7; 2 g/100g; g/100g; g/100g E 20171231 12027-102_a3085dad-4a66-4505-9f09-0030441a6dfe 12027-102 HUMAN OTC DRUG wet n wild Ultimate Match OCTINOXATE OXYBENZONE LIQUID TOPICAL 20111201 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc OCTINOXATE; OXYBENZONE 6; 2 mL/100mL; mL/100mL E 20171231 12027-103_134664ad-3aed-4b22-8bed-3acc3b685030 12027-103 HUMAN OTC DRUG wet n wild coloricon bronzer OCTINOXATE OXYBENZONE POWDER TOPICAL 20111201 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc OCTINOXATE; OXYBENZONE 5; 1.5 g/100g; g/100g E 20171231 12027-104_16cf7f06-07f8-49c6-95a6-0a660a770d53 12027-104 HUMAN OTC DRUG wet n wild Ultimate Sheer OCTINOXATE OXYBENZONE LIQUID TOPICAL 20111201 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc OCTINOXATE; OXYBENZONE 6; 2 mL/100mL; mL/100mL E 20171231 12027-105_8ff3825c-aef3-4cef-a3fb-969cdbc9b71a 12027-105 HUMAN OTC DRUG Wet n Wild Fergie BB Cream SPF 15 Titanium Dioxide CREAM TOPICAL 20130531 OTC MONOGRAPH NOT FINAL part352 Markwins Beauty Products Inc. TITANIUM DIOXIDE 3.8 g/100mL E 20171231 12027-106_23f3d9a0-53cb-4c09-a575-28882775b556 12027-106 HUMAN OTC DRUG Black Radiance True Complexion BB Cream SPF 15 HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130913 OTC MONOGRAPH NOT FINAL part352 Markwins Beauty Products Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE 4; 2; 3 g/100mL; g/100mL; g/100mL E 20171231 12027-107_6289bfcd-e92b-3d6e-e053-2991aa0aadd2 12027-107 HUMAN OTC DRUG MEGACUSHION FOUNDATION SPF 15 Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide LIQUID TOPICAL 20180105 OTC MONOGRAPH NOT FINAL part352 Markwins Beauty Products, Inc. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.96; 6.73; 7; 2.5 g/100g; g/100g; g/100g; g/100g N 20191231 12027-200_378980b8-f615-32f3-e054-00144ff8d46c 12027-200 HUMAN OTC DRUG Lip Smacker Sport SPF Lip Balm Padimate O, Octinoxate, Oxybenzone STICK TOPICAL 20160318 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc. OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 12027-201_2c11bb07-0616-20b1-e054-00144ff8d46c 12027-201 HUMAN OTC DRUG Disney Frozen SPF Lip Smacker Lip Balm Padimate O, Oxybenzone, Octinoxate STICK TOPICAL 20160218 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc PADIMATE O; OCTINOXATE; OXYBENZONE 8; 7.5; 6 g/100g; g/100g; g/100g E 20171231 12027-202_2dba959a-0d62-4317-e054-00144ff8d46c 12027-202 HUMAN OTC DRUG Disney Classic Characters Lip Smacker SPF Lip Balm Padimate O, Oxybenzone, Octinoxate STICK TOPICAL 20160311 OTC MONOGRAPH FINAL part352 Markwins Beauty Products PADIMATE O; OCTINOXATE; OXYBENZONE 8; 7.5; 6 g/100g; g/100g; g/100g E 20171231 12027-203_2dccf452-a895-0bd5-e054-00144ff8d46c 12027-203 HUMAN OTC DRUG Disney Cars Lip Smacker SPF Lip Balm Padimate O, Oxybenzone, Octinoxate STICK TOPICAL 20160311 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc. OCTINOXATE; PADIMATE O; OXYBENZONE 7.5; 8; 6 g/100g; g/100g; g/100g E 20171231 12027-204_2c24d6ab-cc93-6bbd-e054-00144ff8d46c 12027-204 HUMAN OTC DRUG Disney Little Mermaid SPF Lip Smacker Lip Balm Padimate O, Octinoxate, Oxybenzone STICK TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc PADIMATE O; OCTINOXATE; OXYBENZONE 8; 7.5; 6 g/100g; g/100g; g/100g E 20171231 12027-205_588a811b-7208-4ea8-e053-2991aa0a6b24 12027-205 HUMAN OTC DRUG Kiss Therapy SPF 30 Strawberry Avobenzone, Homosalate, Octocrylene STICK TOPICAL 20170906 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc. HOMOSALATE; OCTOCRYLENE; AVOBENZONE 10; 10; 3 g/100g; g/100g; g/100g N 20181231 12027-206_588c7a44-a362-676a-e053-2a91aa0a57b3 12027-206 HUMAN OTC DRUG Kiss Therapy SPF 30 Grapefruit Avobenzone, Homosalate, Octocrylene STICK TOPICAL 20170906 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3; 10; 10 g/100g; g/100g; g/100g N 20181231 12027-207_588da56e-fef8-fde6-e053-2a91aa0a6339 12027-207 HUMAN OTC DRUG Kiss Therapy SPF 30 Superfruit Avobenzone, Homosalate,Octocrylene STICK TOPICAL 20170906 OTC MONOGRAPH FINAL part352 Markwins Beauty Products, Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3; 10; 10 g/100g; g/100g; g/100g N 20181231 12027-208_589e1060-27db-5c4d-e053-2991aa0a1d07 12027-208 HUMAN OTC DRUG Kiss Therapy Medicated Lip Balm Camphor, Menthol, Petrolatum STICK TOPICAL 20170907 OTC MONOGRAPH NOT FINAL part348 Markwins Beauty Products, Inc. MENTHOL; PETROLATUM; CAMPHOR (NATURAL) .8; 30; .8 g/100g; g/100g; g/100g N 20181231 12027-209_61d08802-5890-1c96-e053-2a91aa0a316f 12027-209 HUMAN OTC DRUG Kiss Therapy SPF 30 Blueberry Lime Lip Balm Avobenzone, Homosalate, Octocrylene STICK TOPICAL 20180102 OTC MONOGRAPH FINAL part352 Marwins Beauty Products, Inc. HOMOSALATE; OCTOCRYLENE; AVOBENZONE 10; 10; 3 g/100g; g/100g; g/100g N 20191231 12027-210_61d19d19-7150-0e8c-e053-2a91aa0a10b4 12027-210 HUMAN OTC DRUG Kiss Therapy SPF 30 Watermelon Rosemary Lip Balm Avobenzone, homosalate, octocrylene STICK TOPICAL 20180102 OTC MONOGRAPH FINAL part352 Marwins Beauty Products, Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3; 10; 10 g/100g; g/100g; g/100g N 20191231 12027-211_61d33ad4-2f2a-1544-e053-2991aa0a6886 12027-211 HUMAN OTC DRUG Kiss Therapy SPF 30 Strawberry Mint Lip Balm Avobenzone, Homosalate, Octocrylene STICK TOPICAL 20180102 OTC MONOGRAPH FINAL part352 Marwins Beauty Products, Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3; 10; 10 g/100g; g/100g; g/100g N 20191231 12027-212_624e1d11-66ff-53ea-e053-2991aa0a22d4 12027-212 HUMAN OTC DRUG Kiss Therapy SPF 30 Cucumber Melon Lip Balm Avobenzone, Homosalate, Octocrylene STICK TOPICAL 20180102 OTC MONOGRAPH FINAL part352 Marwins Beauty Products, Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3; 10; 10 g/100g; g/100g; g/100g N 20191231 12090-0015_3995dad7-8000-675d-e054-00144ff8d46c 12090-0015 HUMAN OTC DRUG Creomulsion For Children DEXTROMETHORPHAN HYDROBROMIDE SYRUP ORAL 20091230 20191231 OTC MONOGRAPH FINAL part341 Summit Industries, Inc. DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL E 20171231 12090-0016_451fa655-d1cb-4229-e054-00144ff88e88 12090-0016 HUMAN OTC DRUG Lantiseptic Dry Skin Therapy LANOLIN CREAM TOPICAL 20160302 OTC MONOGRAPH FINAL part347 Santus LLC LANOLIN 300 mg/g N 20181231 12090-0019_451f72df-5ff8-1f2b-e054-00144ff8d46c 12090-0019 HUMAN OTC DRUG Lantiseptic Original Skin Protectant LANOLIN CREAM TOPICAL 20160303 OTC MONOGRAPH FINAL part347 Santus LLC LANOLIN 500 mg/g N 20181231 12090-0024_3995dc7d-5bed-6372-e054-00144ff8d46c 12090-0024 HUMAN OTC DRUG Creomulsion Cough Medicine Adult Formula DEXTROMETHORPHAN HYDROBROMIDE SYRUP ORAL 20091230 20191231 OTC MONOGRAPH FINAL part341 Summit Industries, Inc. DEXTROMETHORPHAN HYDROBROMIDE 20 mg/15mL E 20171231 12090-0032_451fa655-d1d8-4229-e054-00144ff88e88 12090-0032 HUMAN OTC DRUG Lantiseptic CaldaZinc MENTHOL, ZINC OXIDE OINTMENT TOPICAL 20160302 OTC MONOGRAPH FINAL part346 Santus LLC MENTHOL; ZINC OXIDE 4.5; 180 mg/g; mg/g N 20181231 12090-0042_597f599d-ec66-429f-b765-6be4f1b650b2 12090-0042 HUMAN OTC DRUG LanoGuard Dry Skin Therapy LANOLIN CREAM TOPICAL 20091230 OTC MONOGRAPH FINAL part347 Summit Industries, Inc. LANOLIN 370 mg/g E 20171231 12090-0061_0c61edf7-96f9-4f42-9b8a-ea6c95daa8b8 12090-0061 HUMAN OTC DRUG Lanoguard Multi-Purpose MENTHOL, CALAMINE, ZINC OXIDE OINTMENT TOPICAL 20130321 OTC MONOGRAPH FINAL part347 Summit Industries, Inc. MENTHOL; FERRIC OXIDE RED; ZINC OXIDE 4.5; 20; 180 mg/g; mg/g; mg/g E 20171231 12090-0074_d47db560-6292-483f-9705-b2cf8f05efab 12090-0074 HUMAN OTC DRUG LanoGuard Daily Care Skin Protectant LANOLIN OINTMENT TOPICAL 20130321 OTC MONOGRAPH FINAL part347 Summit Industries, Inc. LANOLIN 300 mg/g E 20171231 12090-0083_451fa655-d1bb-4229-e054-00144ff88e88 12090-0083 HUMAN OTC DRUG Lantiseptic Protective PETROLATUM OINTMENT TOPICAL 20160330 OTC MONOGRAPH FINAL part347 Santus LLC PETROLATUM 430 mg/mL N 20181231 12090-1235_47f174e6-641e-5105-e054-00144ff88e88 12090-1235 HUMAN OTC DRUG Boroleum for Nasal Soreness CAMPHOR, MENTHOL, WHITE PETROLATUM OINTMENT TOPICAL 20101210 OTC MONOGRAPH NOT FINAL part348 Santus LLC CAMPHOR (SYNTHETIC); MENTHOL; PETROLATUM 10; 5.4; 979.2 mg/g; mg/g; mg/g N 20181231 12121-001_d5582ab4-4221-41d8-b702-085aee50b906 12121-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19550101 NDA NDA205767 Badger Welding Supplies, Inc OXYGEN 99 L/100L N 20181231 12121-002_be9b801d-c5b0-4274-b065-a0242c6e2f51 12121-002 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19550101 NDA NDA209989 Badger Welding Supplies, Inc NITROUS OXIDE 99 L/100L N 20181231 12121-006_5e07977f-aeac-465c-b22c-1d5555b262fa 12121-006 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19550101 NDA NDA205766 Badger Welding Supplies, Inc NITROGEN 99 L/100L N 20181231 12164-005_ee3f8d18-2657-4588-ba7d-7066c3f47d59 12164-005 HUMAN PRESCRIPTION DRUG Sevoflurane sevoflurane LIQUID RESPIRATORY (INHALATION) 20071119 ANDA ANDA078650 Halocarbon Products Corp. SEVOFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 12164-012_66fe089f-15a3-4f7f-a104-4bef76a25154 12164-012 HUMAN PRESCRIPTION DRUG Isoflurane Isoflurane LIQUID RESPIRATORY (INHALATION) 19991020 ANDA ANDA075225 Halocarbon Products Corp. ISOFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 12165-100_2bf0acb6-5b34-467d-9056-32f3ff0c4c1c 12165-100 HUMAN PRESCRIPTION DRUG GRAFCO APPLICATOR 15 CM Silver Nitrate STICK TOPICAL 19490419 UNAPPROVED DRUG OTHER GF Health Products, Inc. SILVER NITRATE; POTASSIUM NITRATE 38.21; 12.74 mg/1; mg/1 N 20181231 12165-200_9cd7ea9b-f39d-48a9-8654-d655e302a0b7 12165-200 HUMAN PRESCRIPTION DRUG GRAFCO APPLICATOR 30 CM Silver Nitrate STICK TOPICAL 19490419 UNAPPROVED DRUG OTHER GF Health Products, Inc. SILVER NITRATE; POTASSIUM NITRATE 52.451; 17.486 mg/1; mg/1 N 20181231 12165-300_e7751ce9-9078-47a4-86b1-539fff034e67 12165-300 HUMAN PRESCRIPTION DRUG GRAFCO APPLICATOR 45 CM Silver Nitrate STICK TOPICAL 19490419 UNAPPROVED DRUG OTHER GF Health Products, Inc. SILVER NITRATE; POTASSIUM NITRATE 73.4314; 24.4804 mg/1; mg/1 N 20181231 12201-001_6154d08c-6a67-cb39-e053-2991aa0a88a1 12201-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130301 NDA NDA206023 CENTRAL NEBRASKA HOME CARE SERVICES OXYGEN 210 mL/L N 20181231 12213-005_63db097f-6ac9-4df5-a135-d5a52e1754b0 12213-005 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19960601 NDA NDA206025 NexAir, LLC CARBON DIOXIDE 991 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 12213-498_ca130bcf-d56e-4afd-b5fc-348057a47cfa 12213-498 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19960601 NDA NDA205850 NexAir, LLC NITROGEN 990 mL/L N 20181231 12213-593_60dcb44e-3f34-6a9c-e053-2991aa0a174f 12213-593 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19960601 NDA NDA206009 NEXAIR, LLC NITROUS OXIDE 990 mL/L N 20181231 12213-700_d0301b03-b133-415d-ad7c-9344198546f7 12213-700 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19960601 NDA NDA205859 NexAir, LLC AIR 1000 mL/L N 20181231 12213-710_b38b3d40-a6e8-4143-a613-035c99c1e09c 12213-710 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19960601 NDA NDA205851 NexAir, LLC HELIUM 999 mL/L N 20181231 12213-720_67da9293-ce11-4479-8bec-9285a0ce3f61 12213-720 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960601 NDA NDA205849 NexAir, LLC OXYGEN 991 mL/L N 20181231 12213-726_b68ae7f0-e619-42e5-952d-89e136d7f61b 12213-726 HUMAN PRESCRIPTION DRUG Carbon Dioxide/Oxygen Mix Carbon Dioxide/Oxygen Mix GAS RESPIRATORY (INHALATION) 19960601 NDA NDA205849 NexAir, LLC OXYGEN 50 mL/L E 20171231 12213-730_0d52a197-c92c-4c2f-8d9b-7678cd5bf433 12213-730 HUMAN PRESCRIPTION DRUG Helium Oxygen Mix Helium Oxygen Mix GAS RESPIRATORY (INHALATION) 19960601 UNAPPROVED MEDICAL GAS NexAir, LLC HELIUM; OXYGEN 800; 200 mL/L; mL/L E 20171231 12213-733_3141f51c-3bf3-48d1-9f39-7a8bbcc48418 12213-733 HUMAN PRESCRIPTION DRUG Nitrogen Oxygen Mix Nitrogen Oxygen Mix GAS RESPIRATORY (INHALATION) 19960601 NDA NDA205849 NexAir, LLC OXYGEN 210 mL/L N 20181231 12213-800_60dc6454-414a-b0c2-e053-2991aa0a733d 12213-800 HUMAN PRESCRIPTION DRUG Carbon Dioxide/Oxygen Mix Carbon Dioxide/Oxygen Mix GAS RESPIRATORY (INHALATION) 19960601 NDA NDA205849 NEXAIR, LLC OXYGEN 50 mL/L N 20181231 12213-801_60dd4f4b-7133-385e-e053-2a91aa0ad5d6 12213-801 HUMAN PRESCRIPTION DRUG Helium/Oxygen Mix Helium/Oxygen Mix GAS RESPIRATORY (INHALATION) 19960601 NDA NDA205849 NEXAIR, LLC OXYGEN 200 mL/L N 20181231 12258-223_8bef575b-3ae0-41e0-beb2-7769f3ed8cfe 12258-223 HUMAN OTC DRUG Curasore Pramoxine Hydrochloride LIQUID TOPICAL 19950831 OTC MONOGRAPH FINAL part346 S.S.S. Company PRAMOXINE HYDROCHLORIDE 1 g/100mL N 20181231 12258-241_2a15a176-7f7a-4d2c-b9a1-fbbd1175abac 12258-241 HUMAN OTC DRUG Green Tetterine Miconazole Nitrate OINTMENT TOPICAL 19940731 OTC MONOGRAPH FINAL part333C S.S.S. Company MICONAZOLE NITRATE 2 g/100g N 20181231 12258-242_c2dc8551-c4cb-462a-9e9f-11a49f916cfc 12258-242 HUMAN OTC DRUG White Tetterine Miconazole Nitrate OINTMENT TOPICAL 19950228 OTC MONOGRAPH FINAL part333C S.S.S. Company MICONAZOLE NITRATE 2 g/100g N 20181231 12488-0100_3bf5c112-24ca-4ecd-b479-8aff193427c7 12488-0100 HUMAN OTC DRUG St. Ives Blemish and Blackhead Control salicylic acid EMULSION TOPICAL 20090601 OTC MONOGRAPH FINAL part333D Alberto Culver USA Inc. SALICYLIC ACID .02 g/g E 20171231 12488-0200_cd125513-f13b-4ccf-aa0d-f304d79964a0 12488-0200 HUMAN OTC DRUG St. Ives Blemish and Blackhead Facial Salicylic Acid SOAP TOPICAL 20090601 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .02 mL/mL E 20171231 12488-0300_b7674d93-a6bb-44ab-a234-e4c743565cf0 12488-0300 HUMAN OTC DRUG St. Ives Naturally Clear Green Tea Facial Salicylic Acid SOAP TOPICAL 20100131 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .01 mL/mL E 20171231 12488-0400_488df815-5438-42ad-9ff7-7efec1b767d2 12488-0400 HUMAN OTC DRUG St. Ives Naturally Clear Green Tea Facial Salicylic Acid SOAP TOPICAL 20100131 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .02 mL/mL E 20171231 12488-0500_3f4f4eb1-0893-48d3-976b-2a87f35ef053 12488-0500 HUMAN OTC DRUG ST. IVES BODY SCRUB NATURALLY CLEAR SKIN GREEN TEA Salicylic Acid EMULSION TOPICAL 20110214 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .02 mL/mL E 20171231 12488-0600_a87e2ede-d0ec-408f-bcf0-ae3fc949b269 12488-0600 HUMAN OTC DRUG ST. IVES BODY WASH NATURALLY CLEAR SKIN GREEN TEA Salicylic Acid SOAP TOPICAL 20110214 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .02 mL/mL E 20171231 12488-0700_b2a9c916-0244-4fc5-8569-b2aeb7eade7c 12488-0700 HUMAN OTC DRUG ST. IVES NATURALLY CLEAR SKIN GREEN TEA FACIAL Salicylic Acid SOAP TOPICAL 20120101 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .02 g/g E 20171231 12488-1000_0f4cc7e8-4cb6-430e-afb4-9f4cb6e4a742 12488-1000 HUMAN OTC DRUG Noxzema Triple Clean Triclosan SOAP TOPICAL 20090601 OTC MONOGRAPH FINAL part333 Alberto-Culver USA Inc. TRICLOSAN .003 g/g E 20171231 12488-1100_c9527f3e-b936-4d90-b925-5f3c9824f332 12488-1100 HUMAN OTC DRUG Noxzema Triple Clean Salicylic Acid CLOTH TOPICAL 20090601 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .02 g/g E 20171231 12488-1200_344434e7-000a-4c61-9dbf-c95a77f2f308 12488-1200 HUMAN OTC DRUG Noxzema Salicyclic Acid SOAP TOPICAL 20100101 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .01 g/g E 20171231 12488-1300_bb7e45f6-0697-456a-adf1-6b275cc8e512 12488-1300 HUMAN OTC DRUG Noxzema Salicyclic Acid SOAP TOPICAL 20100101 OTC MONOGRAPH FINAL part333D Alberto-Culver USA Inc. SALICYLIC ACID .01 mL/mL E 20171231 12488-1800_aba16eab-dfe7-4370-bf7a-43059ccccf0d 12488-1800 HUMAN OTC DRUG Nu Skin Epoch Alcohol GEL TOPICAL 20090601 OTC MONOGRAPH FINAL part333 Alberto-Culver USA Inc. ALCOHOL 61.9937 mL/100mL N 20181231 12488-2000_ba74ffda-eafa-4d17-838e-c2f4af85227b 12488-2000 HUMAN OTC DRUG Simple Vital Vitamin Day SPF 15 Homosalate, Octisalate, Avobenzone, and Octocrylene EMULSION TOPICAL 20120101 OTC MONOGRAPH FINAL part352 Alberto-Culver USA Inc HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE .12; .05; .03; .027 g/g; g/g; g/g; g/g E 20171231 12496-0757_3837aa5b-dcf5-4c1b-bb37-b20882b9ddf5 12496-0757 HUMAN PRESCRIPTION DRUG Buprenex buprenorphine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19850630 NDA NDA018401 Reckitt Benckiser Pharmaceuticals Inc BUPRENORPHINE HYDROCHLORIDE .3 mg/mL Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 12496-1202_0f5a68db-888c-4348-a497-d657b5bb8888 12496-1202 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride FILM, SOLUBLE SUBLINGUAL 20100913 NDA NDA022410 Indivior Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 12496-1204_0f5a68db-888c-4348-a497-d657b5bb8888 12496-1204 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride FILM, SOLUBLE SUBLINGUAL 20120824 NDA NDA022410 Indivior Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 4; 1 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 12496-1208_0f5a68db-888c-4348-a497-d657b5bb8888 12496-1208 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride FILM, SOLUBLE SUBLINGUAL 20100913 NDA NDA022410 Indivior Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 12496-1212_0f5a68db-888c-4348-a497-d657b5bb8888 12496-1212 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride FILM, SOLUBLE SUBLINGUAL 20120824 NDA NDA022410 Indivior Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 12; 3 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 12516-0592_4057b792-ee8b-46ad-a497-9691e43d362b 12516-0592 HUMAN PRESCRIPTION DRUG ELOXATIN oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090722 NDA NDA021759 Aventis Pharma Ltd. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 12546-101_2e91c84d-84f2-493b-9520-18e043f005e1 12546-101 HUMAN OTC DRUG Halls Ice Peppermint Menthol LOZENGE ORAL 20161121 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 10 mg/1 N 20181231 12546-103_86438c79-3168-4d2d-97ac-6843a8ab7826 12546-103 HUMAN OTC DRUG Halls Sugar Free Black Cherry Menthol LOZENGE ORAL 20131001 20180719 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 6.6 mg/1 N 20181231 12546-104_0c7589e1-7762-4ac3-9d61-eecc4de75370 12546-104 HUMAN OTC DRUG Halls Sugar Free Black Cherry Menthol LOZENGE ORAL 20160613 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5.8 mg/1 N 20181231 12546-105_b6da0e76-e3b4-4a7e-bbfe-807b0cd1caa3 12546-105 HUMAN OTC DRUG Halls Mocha Mint Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5 mg/1 E 20171231 12546-106_5244bae0-f702-40ee-9fc8-77db41ecf51f 12546-106 HUMAN OTC DRUG Halls Apple Cider Menthol LOZENGE ORAL 20130723 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5.7 mg/1 E 20171231 12546-107_2483f468-67d6-49d9-bd46-7b1902908f1f 12546-107 HUMAN OTC DRUG Halls Sugar Free Black Cherry Menthol LOZENGE ORAL 20110701 OTC MONOGRAPH FINAL part341 Kraft Foods Global, Inc. MENTHOL 3.7 mg/1 E 20171231 12546-108_9fec7127-f1bc-445c-a0a9-77cedd87f185 12546-108 HUMAN OTC DRUG Halls Butterscotch Menthol LOZENGE ORAL 20111201 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5 mg/1 E 20171231 12546-109_0f85df43-2804-4a0c-b25c-2c78f9c8e218 12546-109 HUMAN OTC DRUG Halls Cherry Menthol LOZENGE ORAL 20170123 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5.8 mg/1 N 20181231 12546-110_89ae6ec5-0e3e-41a8-9d71-7be9968e1d1c 12546-110 HUMAN OTC DRUG Halls Honey Lemon Menthol LOZENGE ORAL 20170123 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 7.5 mg/1 N 20181231 12546-111_81f68767-1fc1-4d6a-9dea-8516e446fc57 12546-111 HUMAN OTC DRUG Halls Ice Peppermint Menthol LOZENGE ORAL 20161031 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 8.2 mg/1 N 20181231 12546-112_9e3bbda0-a863-4152-94b8-49d012564bf3 12546-112 HUMAN OTC DRUG Halls MENTHO-LYPTUS Menthol LOZENGE ORAL 20161104 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5.4 mg/1 N 20181231 12546-113_bcac7a35-6fb4-4d94-ac35-5547549c43a1 12546-113 HUMAN OTC DRUG Halls Spearmint Menthol LOZENGE ORAL 20161107 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 4.6 mg/1 N 20181231 12546-114_55ce0444-4bcd-4a29-bb92-e511c01ae1d4 12546-114 HUMAN OTC DRUG Halls Strawberry Menthol LOZENGE ORAL 20160826 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.7 mg/1 N 20181231 12546-115_4c0375e2-0c24-4d02-a633-fbf50a3d584d 12546-115 HUMAN OTC DRUG Halls Tropical Fruit Menthol LOZENGE ORAL 20161003 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.7 mg/1 N 20181231 12546-150_66ab6e81-a377-4bce-82a8-e183a25ddcb5 12546-150 HUMAN OTC DRUG Breezers Tropical Chill Pectin LOZENGE ORAL 20161121 OTC MONOGRAPH NOT FINAL part356 Mondelez Global LLC PECTIN 7 mg/1 N 20181231 12546-151_ce2c36d7-0a9d-4742-87b7-10c50e33de24 12546-151 HUMAN OTC DRUG Breezers Cool Berry Pectin LOZENGE ORAL 20160803 OTC MONOGRAPH NOT FINAL part356 Mondelez Global LLC PECTIN 7 mg/1 N 20181231 12546-164_c7fe5351-522d-4db0-aa0e-935733fa0d77 12546-164 HUMAN OTC DRUG Halls Mentholyptus Menthol LOZENGE ORAL 20131001 20180906 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 6.5 mg/1 N 20181231 12546-165_96108f36-1a5f-4981-84d4-67bbd72f8015 12546-165 HUMAN OTC DRUG Halls Cherry Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 7 mg/1 N 20181231 12546-219_95c09aa3-9ff0-489e-8817-be1e56196860 12546-219 HUMAN OTC DRUG Halls Strawberry Menthol LOZENGE ORAL 20170116 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 3.2 mg/1 N 20181231 12546-223_cc931ab7-233c-4b28-905b-1f2e26844f95 12546-223 HUMAN OTC DRUG Halls Sugar Free Honey Berry Menthol LOZENGE ORAL 20161114 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.5 mg/1 N 20181231 12546-224_b55c3f43-cb87-47ff-966b-17aacfd5d273 12546-224 HUMAN OTC DRUG Halls Naturals Honey Lemon Chamomile Menthol LOZENGE ORAL 20130807 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.5 mg/1 E 20171231 12546-310_6fe112da-d799-4278-8339-a976406618be 12546-310 HUMAN OTC DRUG Halls Honey Lemon Menthol LOZENGE ORAL 20131001 20180705 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 9.1 mg/1 N 20181231 12546-311_ac6cc002-b4f2-4194-86e1-fe354352da91 12546-311 HUMAN OTC DRUG Halls Extra Strong Menthol Menthol LOZENGE ORAL 20160808 OTC MONOGRAPH NOT FINAL part356 Mondelez Group LLC MENTHOL 15 mg/1 N 20181231 12546-313_30e3f7ae-d7db-41cc-9d62-519c779f80cf 12546-313 HUMAN OTC DRUG Halls Sugar Free Extra Strong Menthol Menthol LOZENGE ORAL 20160912 OTC MONOGRAPH NOT FINAL part356 Mondelez Global LLC MENTHOL 15 mg/1 N 20181231 12546-314_6ccdfdc8-d6c6-46a0-95c3-c722e1822fe0 12546-314 HUMAN OTC DRUG HallsSugar Free Extra Sugar Free Extra Strong Menthol Menthol LOZENGE ORAL 20140204 OTC MONOGRAPH NOT FINAL part356 Mondelez Global LLC MENTHOL 18 mg/1 E 20171231 12546-315_8ba5679f-52bb-49d8-802f-fbca3ac7d437 12546-315 HUMAN OTC DRUG HallsMelon Splash Melon Splash Menthol LOZENGE ORAL 20140204 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 3.1 mg/1 E 20171231 12546-316_3f2464b7-8488-4411-be2c-7e81df083d9b 12546-316 HUMAN OTC DRUG Halls Melon Splash Menthol LOZENGE ORAL 20171114 20190121 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.7 mg/1 N 20181231 12546-317_f2c1461c-708e-4286-a429-e6416d8392e3 12546-317 HUMAN OTC DRUG Halls Honey Menthol LOZENGE ORAL 20150501 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.7 mg/1 N 20181231 12546-318_42e3fcdd-1b18-416e-85aa-19d8b7d2226d 12546-318 HUMAN OTC DRUG Halls Mint Bliss Menthol LOZENGE ORAL 20160202 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 4.3 mg/1 N 20181231 12546-319_e9e88607-0b5f-45be-aeff-65ea7a987222 12546-319 HUMAN OTC DRUG Halls Honey Lemon Menthol LOZENGE ORAL 20160729 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 7.5 mg/1 N 20181231 12546-320_9fd364e4-fc33-4127-838f-f763fad2f99d 12546-320 HUMAN OTC DRUG Halls Honey Lemon Menthol LOZENGE ORAL 20160926 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 8.8 mg/1 N 20181231 12546-321_0b3f7b1b-9e31-4866-a4b5-b2b713dc91fa 12546-321 HUMAN OTC DRUG Halls Menthol Menthol LOZENGE ORAL 20160812 OTC MONOGRAPH NOT FINAL part356 Mondelez Group LLC MENTHOL 18 mg/1 N 20181231 12546-330_71c091e2-1644-4c3f-b807-bc009e5f3880 12546-330 HUMAN OTC DRUG Halls Sugar Free Black Cherry Menthol LOZENGE ORAL 20161003 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 6.7 mg/1 N 20181231 12546-331_248e3672-8acc-42ed-bc1f-c5e605114298 12546-331 HUMAN OTC DRUG Halls Cherry Menthol LOZENGE ORAL 20161003 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 7.6 mg/1 N 20181231 12546-332_82f80d55-f28c-4b8a-8350-b67436b2b5c1 12546-332 HUMAN OTC DRUG Halls Spearmint Menthol LOZENGE ORAL 20161212 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5.4 mg/1 N 20181231 12546-333_3b7daa28-1684-4b5b-87a5-208235c3ff28 12546-333 HUMAN OTC DRUG Halls Cherry Menthol LOZENGE ORAL 20161121 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 6.8 mg/1 N 20181231 12546-334_77d74a09-2e0f-4a02-939f-5322b9951bbb 12546-334 HUMAN OTC DRUG Halls Mentholyptus Menthol LOZENGE ORAL 20161114 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 6.4 mg/1 N 20181231 12546-335_2138fdb8-a07b-4a07-a089-d00215872f27 12546-335 HUMAN OTC DRUG Halls Orange Menthol LOZENGE ORAL 20170630 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.5 mg/1 N 20181231 12546-336_fcc83f30-942a-4e66-8194-c5228dfa352c 12546-336 HUMAN OTC DRUG Halls Kids Cherry Menthol LOZENGE ORAL 20170421 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5 mg/1 N 20181231 12546-337_c7b8438e-5254-4448-8885-73c471d62bb9 12546-337 HUMAN OTC DRUG Halls Kids Strawberry Menthol LOZENGE ORAL 20170421 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5 mg/1 N 20181231 12546-338_8f9e5098-e049-466c-baff-37425ba20e8d 12546-338 HUMAN OTC DRUG Halls Honey Vanilla Menthol LOZENGE ORAL 20171218 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.5 mg/1 N 20181231 12546-339_d1ed8375-5f79-4c13-acd2-7c86a3537b8d 12546-339 HUMAN OTC DRUG Halls Honey Chamomile Menthol LOZENGE ORAL 20171218 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.5 mg/1 N 20181231 12546-352_a74d850b-528d-469a-8997-415432494d4f 12546-352 HUMAN OTC DRUG Breezers Creamy Strawberry Pectin LOZENGE ORAL 20160803 OTC MONOGRAPH NOT FINAL part356 Mondelez Global LLC PECTIN 7 mg/1 N 20181231 12546-613_09d63fd4-9d48-4bee-a170-417f5baa29e8 12546-613 HUMAN OTC DRUG Halls Sugar Free Citrus Blend Menthol LOZENGE ORAL 20161024 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5 mg/1 N 20181231 12546-640_15c4e180-cc02-444e-9f75-78b25ce9cd03 12546-640 HUMAN OTC DRUG Halls Sugar Free Mountain Menthol Menthol LOZENGE ORAL 20160815 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 5.8 mg/1 N 20181231 12546-642_4c87e206-548c-4c6d-a672-8035c764ae40 12546-642 HUMAN OTC DRUG Halls Sugar Free Honey Lemon Menthol LOZENGE ORAL 20160613 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 7.6 mg/1 N 20181231 12546-692_63864dc3-34da-4310-a98f-a1cb6f5d00f0 12546-692 HUMAN OTC DRUG Halls Sugar Free Assorted Mints Menthol LOZENGE ORAL 20171003 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 9.4 mg/1 N 20181231 12546-720_2efefc10-067d-45d0-8cd8-6d4ef428eb8f 12546-720 HUMAN OTC DRUG Halls Breezers Sugar Free Cool Berry Pectin LOZENGE ORAL 20160926 OTC MONOGRAPH NOT FINAL part356 Mondelez Global LLC PECTIN 7 mg/1 N 20181231 12546-985_08109a1f-5071-4c8c-b7f0-8de7e1dd0f0b 12546-985 HUMAN OTC DRUG Halls Plus Strawberry Menthol LOZENGE ORAL 20131001 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 2.7 mg/1 E 20171231 12546-987_375fa011-1b7d-4ba8-9b59-3947c14a2d0a 12546-987 HUMAN OTC DRUG Halls Plus Honey Menthol LOZENGE ORAL 20140129 20180531 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 7.5 mg/1 N 20181231 12546-988_23623a1e-e523-41f2-b5f0-5e438ec18fc4 12546-988 HUMAN OTC DRUG Halls Plus Cherry Menthol LOZENGE ORAL 20131001 20180802 OTC MONOGRAPH FINAL part341 Mondelez Global LLC MENTHOL 7.5 mg/1 N 20181231 12634-023_357dc373-4314-1e36-e054-00144ff8d46c 12634-023 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Apotheca Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 12634-027_3683a7d1-b1d7-3b08-e054-00144ff8d46c 12634-027 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Apotheca Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 12634-028_375fdeb5-e1ca-1a8e-e054-00144ff8d46c 12634-028 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20000627 ANDA ANDA089452 Apotheca Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 12634-083_35bd4587-6e8b-13a1-e054-00144ff88e88 12634-083 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 Apotheca Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 12634-092_2731607b-69a3-5669-e054-00144ff8d46c 12634-092 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Apotheca Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 12634-111_131d4041-7086-411f-ab71-37c091d1377a 12634-111 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 19960401 OTC MONOGRAPH NOT FINAL part343 Apotheca, Inc ACETAMINOPHEN 325 mg/1 N 20181231 12634-112_27813735-2940-67a5-e054-00144ff88e88 12634-112 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Apotheca Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 12634-118_46efec4f-f86d-0534-e054-00144ff88e88 12634-118 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride TABLET ORAL 20100907 ANDA ANDA040747 Apotheca Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 12634-120_9e5f53d8-1f64-4021-8b6e-7f74694919ab 12634-120 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19830415 OTC MONOGRAPH NOT FINAL part343 Apotheca, Inc ASPIRIN 325 g/1 N 20181231 12634-144_68fe60f5-37c3-4256-9c9d-33d3e3580a90 12634-144 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20090320 ANDA ANDA040746 Apotheca, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 12634-160_543aa8e5-219e-41d8-8ffa-9ae1446d3391 12634-160 HUMAN PRESCRIPTION DRUG INDOMETHACIN ER INDOMETHACIN CAPSULE ORAL 20100304 ANDA ANDA079175 Apotheca, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 12634-169_46dff4c0-9aad-20f9-e054-00144ff8d46c 12634-169 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Apotheca Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 12634-171_36fc14a6-4944-4e90-e054-00144ff8d46c 12634-171 HUMAN PRESCRIPTION DRUG IBUPROFEN Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Apotheca Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 12634-172_2783e34b-384e-04af-e054-00144ff8d46c 12634-172 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 Apotheca Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 12634-177_db550e63-43dc-4126-b857-010383501dd0 12634-177 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim DS Sulfamethoxazole and Trimethoprim DS TABLET ORAL 19940621 ANDA ANDA076899 Apotheca Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 12634-179_0048d662-23c4-4e28-815e-ce094951da05 12634-179 HUMAN PRESCRIPTION DRUG METHERGINE METHYLERGONOVINE MALEATE TABLET, COATED ORAL 20061227 NDA NDA006035 Apotheca, Inc. METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 12634-183_353028af-ec9d-690b-e054-00144ff88e88 12634-183 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Apotheca Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 12634-184_357d7013-18b1-3554-e054-00144ff88e88 12634-184 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19720522 ANDA ANDA080292 Apotheca Inc. PREDNISONE 5 mg/1 N 20181231 12634-185_353028af-ec9d-690b-e054-00144ff88e88 12634-185 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Apotheca Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 12634-188_280c9fe8-339a-177a-e054-00144ff88e88 12634-188 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 Apotheca Inc. PREDNISONE 20 mg/1 N 20181231 12634-189_27fdf443-7545-3879-e054-00144ff88e88 12634-189 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Apotheca Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 12634-191_36fc14a6-4944-4e90-e054-00144ff8d46c 12634-191 HUMAN PRESCRIPTION DRUG IBUPROFEN Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Apotheca Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 12634-193_467cacc2-6470-342c-e054-00144ff8d46c 12634-193 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072192 Apotheca Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 12634-246_280dc4d4-7774-3c13-e054-00144ff8d46c 12634-246 HUMAN OTC DRUG Rugby Travel Sickness Meclizine HCl, 25 mg Each (ANTIEMETIC) Meclizine HCl TABLET, CHEWABLE ORAL 20140819 OTC MONOGRAPH FINAL part336 Apotheca Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 12634-248_27fc49cd-e0df-014c-e054-00144ff88e88 12634-248 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Apotheca Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 12634-260_34f02e3f-cc77-53e4-e054-00144ff88e88 12634-260 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 20090330 ANDA ANDA090118 Apotheca Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 12634-264_357d7f87-1694-2dc5-e054-00144ff88e88 12634-264 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 19970625 ANDA ANDA040099 Apotheca Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 12634-415_27fa784f-085a-0b97-e054-00144ff8d46c 12634-415 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Apotheca Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 12634-416_46675cd8-ad7f-40ae-e054-00144ff8d46c 12634-416 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20160224 ANDA ANDA077293 Apotheca Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 12634-418_ca133ae3-6acb-4d3e-82e0-4946943b7440 12634-418 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19990610 ANDA ANDA091179 Apotheca, Inc PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 12634-424_46f1e0ac-d67e-4419-e054-00144ff88e88 12634-424 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 Apotheca Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 12634-434_273003a5-23c4-21e4-e054-00144ff88e88 12634-434 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20080118 ANDA ANDA065248 Apotheca Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 12634-436_37247772-a8fb-46ba-e054-00144ff88e88 12634-436 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Apotheca Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 12634-437_29dc4824-73b8-600e-e054-00144ff8d46c 12634-437 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19911017 ANDA ANDA089346 Apotheca Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 12634-445_f603db60-428d-470d-96d6-2c9486dfa784 12634-445 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 19961221 ANDA ANDA084325 Apotheca, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 12634-452_35d19524-1c96-64e5-e054-00144ff88e88 12634-452 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20141215 ANDA ANDA090278 Apotheca Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 12634-453_35ba1f4c-d50f-0bd5-e054-00144ff88e88 12634-453 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20141215 ANDA ANDA090278 Apotheca Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 12634-465_91f3b736-ecf5-4517-b8d9-a151308db836 12634-465 HUMAN PRESCRIPTION DRUG Clonidine HYDROCHLORIDE Clonidine HYDROCHLORIDE TABLET ORAL 19961221 ANDA ANDA070974 Apotheca, Inc CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 12634-471_f603db60-428d-470d-96d6-2c9486dfa784 12634-471 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20090630 ANDA ANDA084324 Apotheca, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 12634-498_35b8ec82-7260-5925-e054-00144ff8d46c 12634-498 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Apotheca Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 12634-502_477e9a4a-19a9-6846-e054-00144ff88e88 12634-502 HUMAN PRESCRIPTION DRUG misoprostol MISOPROSTOL TABLET ORAL 20091227 NDA AUTHORIZED GENERIC NDA019268 Apotheca Inc. MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 12634-516_3648073a-ac05-2c76-e054-00144ff8d46c 12634-516 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 Apotheca Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 12634-518_2757f53a-602c-4678-80f5-61c3d9dfd4a3 12634-518 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20140214 ANDA ANDA091239 Apotheca, Inc IBUPROFEN 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 12634-520_34f57b50-d012-2c77-e054-00144ff88e88 12634-520 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 Apotheca Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 12634-525_29b4d4db-2de7-06ee-e054-00144ff88e88 12634-525 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20000118 ANDA ANDA074215 Apotheca, Inc ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 12634-526_29b3e671-afb3-2c71-e054-00144ff8d46c 12634-526 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET ORAL 20020503 ANDA ANDA089805 Apotheca, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 12634-528_27fe4bb9-282f-42ca-e054-00144ff88e88 12634-528 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 ANDA ANDA090478 Apotheca Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 12634-529_7f85d8a7-0144-44d4-9a61-fb24a144d5c8 12634-529 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20091209 ANDA ANDA071321 Apotheca, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 12634-530_46cc3fe9-641c-5efd-e054-00144ff88e88 12634-530 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride Diethylpropion hydrochloride TABLET ORAL 19590806 NDA NDA011722 Apotheca Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 12634-531_2a2ec5f4-ddaa-383d-e054-00144ff8d46c 12634-531 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 Apotheca Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 12634-533_4678cb48-af8b-6ecc-e054-00144ff8d46c 12634-533 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Apotheca Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 12634-539_37b5963b-0bc0-073e-e054-00144ff8d46c 12634-539 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20000705 ANDA ANDA089452 Apotheca Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 12634-547_36970e45-4158-5b83-e054-00144ff88e88 12634-547 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20031023 ANDA ANDA040525 Apotheca Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 12634-552_36d2ea29-459a-6ac9-e054-00144ff88e88 12634-552 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Apotheca Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 12634-562_46cafc45-78b0-38a1-e054-00144ff88e88 12634-562 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 Apotheca Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 12634-599_46c9e361-39e2-6f5e-e054-00144ff8d46c 12634-599 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 Apotheca Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 12634-600_368408e8-87e1-4092-e054-00144ff88e88 12634-600 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Apotheca Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 12634-604_37264962-2416-3a7b-e054-00144ff8d46c 12634-604 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 Apotheca Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 12634-605_36fec1f1-5e74-5764-e054-00144ff8d46c 12634-605 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Apotheca Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 12634-607_60d3cc49-2b2b-4b64-bbfb-32814a6da433 12634-607 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET ORAL 20120630 ANDA ANDA074342 APOTHECA, INC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 12634-616_91924151-259e-4f6b-869c-01ba4a4729ae 12634-616 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen hydrocodone bitartrate and acetaminophen SOLUTION ORAL 20140331 ANDA ANDA040838 Apotheca, Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/120mL; mg/120mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 12634-629_357d9c23-a8fc-3b21-e054-00144ff88e88 12634-629 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Apotheca Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 12634-674_47533163-35dc-00ae-e054-00144ff8d46c 12634-674 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Apotheca Inc. LEVOFLOXACIN 750 mg/1 N 20181231 12634-675_2780a753-41fa-4f9b-e054-00144ff88e88 12634-675 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Apotheca Inc. LEVOFLOXACIN 500 mg/1 N 20181231 12634-682_36fc14a6-4944-4e90-e054-00144ff8d46c 12634-682 HUMAN PRESCRIPTION DRUG IBUPROFEN Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Apotheca Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 12634-684_27fec1d8-54db-4fed-e054-00144ff88e88 12634-684 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Apotheca Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 12634-686_27ff96c5-dc37-1415-e054-00144ff8d46c 12634-686 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Apotheca Inc. PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 12634-687_36713557-ab03-3c88-e054-00144ff88e88 12634-687 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 Apotheca Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 12634-691_46d9dd37-a8c5-4c01-e054-00144ff8d46c 12634-691 HUMAN PRESCRIPTION DRUG diethylpropion hydrochloride er diethylpropion hydrochloride er TABLET ORAL 19601117 NDA NDA012546 Apotheca Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 12634-697_271bf420-cc51-52eb-e054-00144ff8d46c 12634-697 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20060313 ANDA ANDA077309 Apotheca Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 12634-698_7f85d8a7-0144-44d4-9a61-fb24a144d5c8 12634-698 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20090115 ANDA ANDA070154 Apotheca, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 12634-729_463a6f4a-c834-2e89-e054-00144ff8d46c 12634-729 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 Apotheca Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 12634-756_46625c1e-8ee1-4178-e054-00144ff88e88 12634-756 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Apotheca Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 12634-757_46625c1e-8ee1-4178-e054-00144ff88e88 12634-757 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Apotheca Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 12634-769_27310a8d-5bb6-4624-e054-00144ff88e88 12634-769 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Apotheca Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 12634-771_467a6c4f-8634-5686-e054-00144ff8d46c 12634-771 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Apotheca Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 12634-779_51ea5805-beef-4741-a63e-76bf0fe03153 12634-779 HUMAN PRESCRIPTION DRUG SULFAMETHOXAZOLE and TRIMETHOPRIM SULFAMETHOXAZOLE and TRIMETHOPRIM SUSPENSION ORAL 20091103 ANDA ANDA074650 Apotheca, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 12634-780_277154a2-2784-3775-e054-00144ff88e88 12634-780 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Apotheca Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 12634-786_2709bacb-b51c-124d-e054-00144ff88e88 12634-786 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET ORAL 20101115 ANDA ANDA076003 APOTHECA, INC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 12634-789_46625c1e-8ee1-4178-e054-00144ff88e88 12634-789 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Apotheca Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 12634-790_463dc8c9-618d-0759-e054-00144ff88e88 12634-790 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 Apotheca Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 12634-809_69956c5a-014b-4e75-b4c1-6e51d7e80315 12634-809 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET ORAL 20051025 ANDA ANDA074754 Apotheca, Inc KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 12634-826_271eab2b-ed12-39f1-e054-00144ff88e88 12634-826 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Apotheca Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 12634-827_bf8d9912-f32f-41d3-8173-a60c80fddc77 12634-827 HUMAN PRESCRIPTION DRUG DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM TABLET ORAL 20070820 ANDA ANDA075229 APOTHECA, INC DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 12634-833_27800e43-e197-3eed-e054-00144ff88e88 12634-833 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 Apotheca Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 12634-838_543aa8e5-219e-41d8-8ffa-9ae1446d3391 12634-838 HUMAN PRESCRIPTION DRUG INDOMETHACIN ER INDOMETHACIN CAPSULE ORAL 20060502 ANDA ANDA074464 Apotheca, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 12634-860_6e315790-ef94-4772-8e76-2565f8b097d4 12634-860 HUMAN OTC DRUG IBUPROFEN IBUPROFEN TABLET ORAL 20090916 ANDA ANDA071333 Apotheca Inc. IBUPROFEN 200 mg/1 N 20181231 12634-867_5f71530d-599c-4eb7-bbf4-716dfdfd09ed 12634-867 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 Apotheca, Inc LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 12634-874_271ddc63-b31c-2f46-e054-00144ff8d46c 12634-874 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Apotheca Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 12634-907_477cedee-6bcf-2a34-e054-00144ff8d46c 12634-907 HUMAN PRESCRIPTION DRUG promethazine hydrochloride and codeine phosphate promethazine hydrochloride and codeine phosphate SYRUP ORAL 20100317 ANDA ANDA090180 Apotheca Inc. PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 12634-909_49d71d3b-fb89-5738-e054-00144ff8d46c 12634-909 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Codeine Phosphate Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 19970826 ANDA ANDA040151 Apotheca Inc CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV N 20181231 12634-910_366ecdba-3d58-63e5-e054-00144ff88e88 12634-910 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 Apotheca Inc. PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 12634-933_51ae34a7-a5eb-47de-8798-60e55a1db305 12634-933 HUMAN PRESCRIPTION DRUG CYTOTEC MISOPROSTOL TABLET ORAL 20100101 NDA NDA019268 Apotheca, Inc MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 12634-942_07f367ed-e5b9-40ec-b812-f5d5a5f7a774 12634-942 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20070723 ANDA ANDA040330 Apotheca, Inc OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 12634-943_9fd5fff8-1baf-4d32-b4d8-9c6fd1de45d4 12634-943 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20070725 ANDA ANDA077884 APOTHECA, INC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 12634-944_9fd5fff8-1baf-4d32-b4d8-9c6fd1de45d4 12634-944 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20070925 ANDA ANDA077884 APOTHECA, INC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 12634-967_277050eb-3e7f-1919-e054-00144ff88e88 12634-967 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075511 Apotheca Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 12634-969_5a66f7eb-5670-4ee1-b48f-0d0a11b554c6 12634-969 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20110128 OTC MONOGRAPH FINAL part341 Apotheca, Inc GUAIFENESIN; CODEINE PHOSPHATE 100; 10 mg/5mL; mg/5mL CV N 20181231 12634-975_29b417d1-cea5-49da-e054-00144ff88e88 12634-975 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 19960426 ANDA ANDA040119 Apotheca Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 12634-987_4ff5ce14-77ce-4757-a40e-e7099f15a011 12634-987 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET ORAL 20100101 ANDA ANDA076677 Apotheca Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 12745-105_1803a33c-d4b6-4ceb-937a-8ba8cbb612fb 12745-105 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19540615 OTC MONOGRAPH FINAL part344 Medical Chemical Corporation ISOPROPYL ALCOHOL 70.14 g/100mL N 20181231 12745-109_df4721e2-1d2c-4225-9e33-53232065f038 12745-109 HUMAN OTC DRUG Compound Benzoin Tincture Tincture of Benzoin LIQUID TOPICAL 19540615 OTC MONOGRAPH NOT FINAL part356 Medical Chemical Corporation BENZOIN RESIN 10 g/100mL N 20181231 12745-140_6a30d77e-3013-482f-919c-2e48f8115a6d 12745-140 HUMAN OTC DRUG Tincture Green Soap Alcohol LIQUID TOPICAL 19540615 OTC MONOGRAPH NOT FINAL part333A Medical Chemical Corporation ROSIN; POTASSIUM HYDROXIDE; ALCOHOL 2.47; 5.961; 24.93 g/100mL; g/100mL; g/100mL E 20171231 12745-144_abfe61a4-161f-4d6c-b51f-1bba796a25ee 12745-144 HUMAN OTC DRUG Surgicide Povidone Iodine POVIDONE IODINE LIQUID TOPICAL 19770803 OTC MONOGRAPH FINAL part333C Medical Chemical Corporation POVIDONE-IODINE 10.5 g/100mL N 20181231 12745-145_3eed8666-eae7-4680-ba40-5a6d751c6cf6 12745-145 HUMAN OTC DRUG BAK 1 750 Benzalkonium Chloride LIQUID TOPICAL 19540615 OTC MONOGRAPH NOT FINAL part333E Medical Chemical Corporation BENZALKONIUM CHLORIDE .1713 g/100mL N 20181231 12745-146_48df0ce5-a1ef-4c36-bf38-7fa3d3899285 12745-146 HUMAN OTC DRUG Scrubidine Povidone Iodine Surgical Scrub POVIDONE IODINE LIQUID TOPICAL 19770803 OTC MONOGRAPH FINAL part333C Medical Chemical Corporation POVIDONE-IODINE 8.64 g/100mL N 20181231 12745-177_9dcdccca-c675-4eea-bec4-06de715651a8 12745-177 HUMAN OTC DRUG Medi Fect Antiseptic Hand Wash Ethyl Alcohol LIQUID TOPICAL 20010514 OTC MONOGRAPH NOT FINAL part333E Medical Chemical Corporation ALCOHOL; DIAZOLIDINYL UREA 59.86; 1 g/100mL; g/100mL N 20181231 12745-202_b12d6dae-2ef8-4e32-8540-0815dfb2b90d 12745-202 HUMAN OTC DRUG HYDROGEN PEROXIDE HYDROGEN PEROXIDE LIQUID TOPICAL 19800721 OTC MONOGRAPH NOT FINAL part333A Medical Chemical Corporation HYDROGEN PEROXIDE 8.57 g/100mL N 20181231 12745-541_958597e1-b700-4432-92e7-c542f2dd1a76 12745-541 HUMAN OTC DRUG Tinted Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19540615 OTC MONOGRAPH FINAL part344 Medical Chemical Corporation ISOPROPYL ALCOHOL 70.14 g/100mL N 20181231 12753-305_adbcd49c-e0c4-40d9-8595-41c1b4406dee 12753-305 HUMAN OTC DRUG 999 COLD REMEDY Acetaminophen, Chlorpheniramine Maleate, Caffeine CAPSULE ORAL 20030703 OTC MONOGRAPH NOT FINAL part343 China Resources Sanjiu Medical & Pharmaceutical Co Ltd ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 100; 2 mg/6000mg; mg/6000mg E 20171231 12753-307_3638fcd4-3721-4e7d-8b1d-14e1d358e13d 12753-307 HUMAN OTC DRUG 999 COLD REMEDY GRANULAR Acetaminophen, Chlorpheniramine Maleate GRANULE ORAL 20030703 OTC MONOGRAPH NOT FINAL part343 China Resources Sanjiu Medical & Pharmaceutical Co Ltd ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 200; 4 mg/90g; mg/90g E 20171231 12753-930_1a9c76a3-1488-47f4-b75c-14e2bef779f3 12753-930 HUMAN OTC DRUG 999 ITCH RELIEF MENTHOL OINTMENT TOPICAL 20030703 OTC MONOGRAPH NOT FINAL part348 China Resources Sanjiu Medical & Pharmaceutical Co Ltd MENTHOL; CAMPHOR (SYNTHETIC); DEXAMETHASONE 200; 200; 15 mg/20000mg; mg/20000mg; mg/20000mg E 20171231 12823-400_fab5934e-3093-4196-bc00-a74b6c0dc729 12823-400 HUMAN OTC DRUG TENDERWRAP Zinc Oxide DRESSING TOPICAL 20100729 OTC MONOGRAPH FINAL part347 Tyco Healthcare Group LP ZINC OXIDE 25 g/1 E 20171231 12823-401_e0388a81-afc9-4ed4-99d8-32f237a11cab 12823-401 HUMAN OTC DRUG TENDERWRAP Zinc Oxide, Calamine DRESSING TOPICAL 20100729 OTC MONOGRAPH FINAL part347 Tyco Healthcare Group LP ZINC OXIDE; FERRIC OXIDE RED; ZINC OXIDE 25; .015; .985 g/1; g/1; g/1 E 20171231 12830-717_47a84c0f-e632-6860-e054-00144ff8d46c 12830-717 HUMAN OTC DRUG M-CLEAR WC Codeine Phosphate, Guaifenesin LIQUID ORAL 20081030 OTC MONOGRAPH FINAL part341 R.A. McNeil Company CODEINE PHOSPHATE; GUAIFENESIN 6.33; 100 mg/5mL; mg/5mL CV N 20181231 12830-754_61459a8a-846e-521d-e053-2991aa0a0162 12830-754 HUMAN OTC DRUG M-END PE Codeine Phosphate, Phenylephrine Hydrochloride, Brompheniramine Maleate LIQUID ORAL 20081111 OTC MONOGRAPH FINAL part341 R.A. McNeil Company CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 6.33; 3.33; 1.33 mg/5mL; mg/5mL; mg/5mL CV N 20181231 12830-762_47a8f224-1465-0d39-e054-00144ff88e88 12830-762 HUMAN OTC DRUG Chlo Tuss Chlophedianol Hydrochloride, Dexbrompheniramine Maleate, Pseudoephedrine Hydrochloride LIQUID ORAL 20131001 OTC MONOGRAPH FINAL part341 R.A. McNeil Company CHLOPHEDIANOL HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 12.5; 1; 30 mg/5mL; mg/5mL; mg/5mL N 20181231 12830-816_47a8c346-578e-05b1-e054-00144ff88e88 12830-816 HUMAN OTC DRUG M-END DMX Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride LIQUID ORAL 20111013 OTC MONOGRAPH FINAL part341 R. A. McNeil Company DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE .667; 10; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 12830-864_5c50b6e8-cae7-9e78-e053-2a91aa0a7319 12830-864 HUMAN OTC DRUG Chlo Hist Chlophedianol Hydrochloride, Dexbrompheniramine Maleate LIQUID ORAL 20140915 OTC MONOGRAPH FINAL part341 R. A. McNeil Company CHLOPHEDIANOL HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE 12.5; 1 mg/5mL; mg/5mL N 20181231 12870-0001_55b4cfc9-9931-3322-e054-00144ff88e88 12870-0001 HUMAN PRESCRIPTION DRUG Silver Nitrate Applicators Silver Nitrate Applicators STICK TOPICAL 19370101 UNAPPROVED DRUG OTHER Arzol Chemical Company POTASSIUM NITRATE; SILVER NITRATE 25; 75 mg/100mg; mg/100mg N 20181231 13107-001_b45a61f0-6179-45fa-929d-7536bd659190 13107-001 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aurolife Pharma LLC MIRTAZAPINE 7.5 mg/1 N 20181231 13107-003_b45a61f0-6179-45fa-929d-7536bd659190 13107-003 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aurolife Pharma LLC MIRTAZAPINE 30 mg/1 N 20181231 13107-004_b59ce525-ede4-4773-866b-56c03dabd976 13107-004 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20160602 ANDA ANDA204575 Aurolife Pharma, LLC HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 13107-005_2627f188-05c8-44ac-845e-80678a0c2fdd 13107-005 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 Aurolife Pharma LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13107-006_2627f188-05c8-44ac-845e-80678a0c2fdd 13107-006 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 Aurolife Pharma LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13107-007_2627f188-05c8-44ac-845e-80678a0c2fdd 13107-007 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 Aurolife Pharma LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13107-011_966d728e-87ca-4491-9411-2ec253eca632 13107-011 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110315 ANDA ANDA077206 Aurolife Pharma LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 13107-012_966d728e-87ca-4491-9411-2ec253eca632 13107-012 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110315 ANDA ANDA077206 Aurolife Pharma LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 13107-013_966d728e-87ca-4491-9411-2ec253eca632 13107-013 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110315 ANDA ANDA077206 Aurolife Pharma LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 13107-014_4821ae32-1354-4c4a-9cb7-16b12f84f204 13107-014 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20130415 ANDA ANDA202675 Aurolife Pharma, LLC GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 13107-019_e5f8ab85-15a7-4965-a530-b274f810dfa3 13107-019 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120411 ANDA ANDA201013 Aurolife Pharma LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 13107-020_e5f8ab85-15a7-4965-a530-b274f810dfa3 13107-020 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120411 ANDA ANDA201013 Aurolife Pharma LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 13107-021_e5f8ab85-15a7-4965-a530-b274f810dfa3 13107-021 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120411 ANDA ANDA201013 Aurolife Pharma LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 13107-031_b45a61f0-6179-45fa-929d-7536bd659190 13107-031 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aurolife Pharma LLC MIRTAZAPINE 15 mg/1 N 20181231 13107-032_b45a61f0-6179-45fa-929d-7536bd659190 13107-032 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aurolife Pharma LLC MIRTAZAPINE 45 mg/1 N 20181231 13107-035_d7eb561f-426d-4340-b620-2d97b0f48b78 13107-035 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET ORAL 20130731 ANDA ANDA202893 Aurolife Pharma, LLC DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 13107-036_d7eb561f-426d-4340-b620-2d97b0f48b78 13107-036 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET ORAL 20130731 ANDA ANDA202893 Aurolife Pharma, LLC DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 13107-043_320314aa-21eb-430b-968e-d90864cf4ca9 13107-043 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20130715 ANDA ANDA201972 Aurolife Pharma LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13107-044_320314aa-21eb-430b-968e-d90864cf4ca9 13107-044 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20130715 ANDA ANDA201972 Aurolife Pharma LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13107-045_320314aa-21eb-430b-968e-d90864cf4ca9 13107-045 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20130715 ANDA ANDA201972 Aurolife Pharma LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13107-046_320314aa-21eb-430b-968e-d90864cf4ca9 13107-046 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20130715 ANDA ANDA201972 Aurolife Pharma LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13107-050_8a37015f-aa57-4a43-9ff0-2ca5540f357d 13107-050 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20091109 ANDA ANDA077691 Aurolife Pharma LLC SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 13107-051_8a37015f-aa57-4a43-9ff0-2ca5540f357d 13107-051 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20091109 ANDA ANDA077691 Aurolife Pharma LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 13107-052_8a37015f-aa57-4a43-9ff0-2ca5540f357d 13107-052 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20091109 ANDA ANDA077691 Aurolife Pharma LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 13107-053_8a37015f-aa57-4a43-9ff0-2ca5540f357d 13107-053 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20091109 ANDA ANDA077691 Aurolife Pharma LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 13107-054_8a37015f-aa57-4a43-9ff0-2ca5540f357d 13107-054 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20091109 ANDA ANDA077691 Aurolife Pharma LLC SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 13107-055_5176403a-4709-4fc6-b1a9-72198e35bff5 13107-055 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20120712 ANDA ANDA202160 Aurolife Pharma LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13107-056_5176403a-4709-4fc6-b1a9-72198e35bff5 13107-056 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20120712 ANDA ANDA202160 Aurolife Pharma LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13107-057_5176403a-4709-4fc6-b1a9-72198e35bff5 13107-057 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20120712 ANDA ANDA202160 Aurolife Pharma LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13107-058_eec7a80c-d9fa-4b21-a42f-23e69d648c97 13107-058 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170105 ANDA ANDA202800 Aurolife Pharma, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 13107-059_eec7a80c-d9fa-4b21-a42f-23e69d648c97 13107-059 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170105 ANDA ANDA202800 Aurolife Pharma, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 13107-060_eec7a80c-d9fa-4b21-a42f-23e69d648c97 13107-060 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170105 ANDA ANDA202800 Aurolife Pharma, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 13107-061_c0edb836-7bf3-454e-a8d6-a7bedb61e958 13107-061 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20170321 ANDA ANDA203068 Aurolife Pharma, LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 13107-062_88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79 13107-062 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100917 ANDA ANDA077739 Aurolife Pharma LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 13107-063_88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79 13107-063 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100917 ANDA ANDA077739 Aurolife Pharma LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 13107-064_88f1abdc-f53e-4ff9-b4c1-3cfbc2609b79 13107-064 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100917 ANDA ANDA077739 Aurolife Pharma LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 13107-066_536dab2f-7586-4d45-b745-99c6cab47743 13107-066 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20150826 ANDA ANDA202039 Aurolife Pharma, LLC FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 13107-067_536dab2f-7586-4d45-b745-99c6cab47743 13107-067 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20141119 ANDA ANDA202039 Aurolife Pharma, LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 13107-068_50061801-4fa3-4065-9a50-86ea5b9e06c2 13107-068 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 13107-069_50061801-4fa3-4065-9a50-86ea5b9e06c2 13107-069 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 13107-070_50061801-4fa3-4065-9a50-86ea5b9e06c2 13107-070 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 13107-071_50061801-4fa3-4065-9a50-86ea5b9e06c2 13107-071 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 13107-072_50061801-4fa3-4065-9a50-86ea5b9e06c2 13107-072 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 13107-073_50061801-4fa3-4065-9a50-86ea5b9e06c2 13107-073 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 13107-074_50061801-4fa3-4065-9a50-86ea5b9e06c2 13107-074 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20131127 ANDA ANDA202424 Aurolife Pharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 13107-076_c7605785-8db2-41eb-90e2-f12275b7b299 13107-076 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20090801 ANDA ANDA077859 Aurolife Pharma LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 13107-077_c7605785-8db2-41eb-90e2-f12275b7b299 13107-077 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20090801 ANDA ANDA077859 Aurolife Pharma LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 13107-088_8aead993-7e4b-45a7-b377-7807ce778867 13107-088 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20150915 ANDA ANDA203502 Aurolife Pharma, LLC METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13107-089_8aead993-7e4b-45a7-b377-7807ce778867 13107-089 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20150915 ANDA ANDA203502 Aurolife Pharma, LLC METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13107-103_e7784d7b-4add-4fc9-843e-f9adc3361f09 13107-103 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20160426 ANDA ANDA204459 Aurolife Pharma, LLC OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 13107-104_e7784d7b-4add-4fc9-843e-f9adc3361f09 13107-104 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20160426 ANDA ANDA204459 Aurolife Pharma, LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 13107-105_63d5899d-b7d4-4270-85e8-263bf3d363be 13107-105 HUMAN PRESCRIPTION DRUG Phentermine Phentermine Hydrochloride CAPSULE ORAL 20170320 ANDA ANDA204318 Aurolife Pharma, LLC PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 13107-106_63d5899d-b7d4-4270-85e8-263bf3d363be 13107-106 HUMAN PRESCRIPTION DRUG Phentermine Phentermine Hydrochloride CAPSULE ORAL 20170320 ANDA ANDA204318 Aurolife Pharma, LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 13107-107_3fb9b225-0316-4eaa-98d1-1a24b8d2291e 13107-107 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 20160517 ANDA ANDA205814 Aurolife Pharma, LLC HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 13107-108_3fb9b225-0316-4eaa-98d1-1a24b8d2291e 13107-108 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 20160517 ANDA ANDA205814 Aurolife Pharma, LLC HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 13107-109_3fb9b225-0316-4eaa-98d1-1a24b8d2291e 13107-109 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 20160517 ANDA ANDA205814 Aurolife Pharma, LLC HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 13107-115_1e3a3321-fd27-4b56-8690-933d0c8738b9 13107-115 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20161121 ANDA ANDA204922 Aurolife Pharma, LLC OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 13107-116_1e3a3321-fd27-4b56-8690-933d0c8738b9 13107-116 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20161121 ANDA ANDA204922 Aurolife Pharma, LLC OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 13107-117_bfaf1e69-cbe9-4dde-8f65-6e730f47120a 13107-117 HUMAN OTC DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20140930 ANDA ANDA204923 Aurolife Pharma, LLC OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 N 20181231 13107-119_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-119 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 13107-120_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-120 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 13107-121_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-121 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 13107-122_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-122 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 13107-123_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-123 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 13107-124_a8e32e4d-cb0a-491b-acbd-2627068e3a70 13107-124 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091025 ANDA ANDA078269 Aurolife Pharma LLC RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 13107-142_5581f10c-3a75-486e-9c3f-98c2c4df970d 13107-142 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Aurolife Pharma LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 13107-143_5581f10c-3a75-486e-9c3f-98c2c4df970d 13107-143 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Aurolife Pharma LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 13107-144_5581f10c-3a75-486e-9c3f-98c2c4df970d 13107-144 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Aurolife Pharma LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 13107-145_5581f10c-3a75-486e-9c3f-98c2c4df970d 13107-145 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Aurolife Pharma LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 13107-154_74d87221-53e0-4454-b37b-494e2fbc876d 13107-154 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Aurolife Pharma LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13107-155_74d87221-53e0-4454-b37b-494e2fbc876d 13107-155 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Aurolife Pharma LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13107-156_74d87221-53e0-4454-b37b-494e2fbc876d 13107-156 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Aurolife Pharma LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13107-157_74d87221-53e0-4454-b37b-494e2fbc876d 13107-157 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Aurolife Pharma LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13107-168_b72f170e-bfa6-463c-9345-31f8a37e43e2 13107-168 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110620 ANDA ANDA078512 Aurolife Pharma LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 13107-169_b72f170e-bfa6-463c-9345-31f8a37e43e2 13107-169 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110620 ANDA ANDA078512 Aurolife Pharma LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 13107-170_b72f170e-bfa6-463c-9345-31f8a37e43e2 13107-170 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110620 ANDA ANDA078512 Aurolife Pharma LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 13108-111_61839182-b614-6b46-e053-2a91aa0a78e3 13108-111 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20150424 ANDA ANDA203911 Spectron mrc, LLC FLUDEOXYGLUCOSE F-18 500 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 13108-211_61839182-b613-6b46-e053-2a91aa0a78e3 13108-211 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 Sodium Fluoride F 18 INJECTION INTRAVENOUS 20150424 ANDA ANDA203912 Spectron mrc, LLC SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 13108-311_61839182-b602-6b46-e053-2a91aa0a78e3 13108-311 HUMAN PRESCRIPTION DRUG Ammonia N 13 Ammonia N 13 INJECTION INTRAVENOUS 20150424 ANDA ANDA204455 Spectron mrc, LLC AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 13136-001_cb18242d-5906-42e3-8212-d704e92ea43b 13136-001 HUMAN OTC DRUG fiteBac SkinCare Germicidal Hand Softening Benzalkonium Chloride GEL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E fiteBac SkinCare, LLC BENZALKONIUM CHLORIDE .029 mL/29.57mL E 20171231 13267-123_879f8311-2765-43cc-bd7d-9c7292e842fe 13267-123 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20050819 NDA NDA021870 THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 13267-234_e2c7e06a-c2f4-4926-8914-e01d1f9506df 13267-234 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20050819 NDA NDA021870 THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH FLUDEOXYGLUCOSE F-18 400 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 13267-456_fa820045-dae1-41a9-b642-bbbff4547483 13267-456 HUMAN PRESCRIPTION DRUG Ammonia N 13 NH3N13 INJECTION INTRAVENOUS 20070823 NDA NDA022119 THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 13267-542_293ff570-c5de-4d2a-8bae-f6218b0b9559 13267-542 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 Sodium Fluoride F 18 INJECTION INTRAVENOUS 20141202 NDA NDA017042 FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH SODIUM FLUORIDE F-18 600 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 13273-209_f65890ab-7296-4194-972b-98ff9637fc7c 13273-209 HUMAN PRESCRIPTION DRUG Salsalate Rx Salsalate TABLET, FILM COATED ORAL 20150101 UNAPPROVED DRUG OTHER ANDAPharm LLC SALSALATE 500 mg/1 N 20181231 13273-210_f65890ab-7296-4194-972b-98ff9637fc7c 13273-210 HUMAN PRESCRIPTION DRUG Salsalate Rx Salsalate TABLET, FILM COATED ORAL 20150101 UNAPPROVED DRUG OTHER ANDAPharm LLC SALSALATE 750 mg/1 N 20181231 13302-785_e5da40f4-994c-4389-b39d-6fc04ca15bf1 13302-785 HUMAN OTC DRUG QS Plus Hand Sanitizing Wipes BENZETHONIUM CHLORIDE CLOTH TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Romaine Companies BENZETHONIUM CHLORIDE 2 mg/g N 20181231 13310-101_26bcf80c-8314-4e10-b32c-452dbce94f7a 13310-101 HUMAN PRESCRIPTION DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20090814 NDA NDA022418 AR Scientific, Inc. FENOFIBRIC ACID 35 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] E 20171231 13310-102_26bcf80c-8314-4e10-b32c-452dbce94f7a 13310-102 HUMAN PRESCRIPTION DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20090814 NDA NDA022418 AR Scientific, Inc. FENOFIBRIC ACID 105 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] E 20171231 13310-119_d6eb54b7-2050-4449-85b8-1592cec62176 13310-119 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20090901 NDA NDA022352 AR Scientific Inc. COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] E 20171231 13310-145_e4750422-45bb-4e1b-9a27-17d31bb588b2 13310-145 HUMAN PRESCRIPTION DRUG Bactrim Sulfamethoxazole and Trimethoprim TABLET ORAL 20041101 NDA NDA017377 AR Scientific, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 13310-146_e4750422-45bb-4e1b-9a27-17d31bb588b2 13310-146 HUMAN PRESCRIPTION DRUG Bactrim DS Sulfamethoxazole and Trimethoprim TABLET ORAL 20041101 NDA NDA017377 AR Scientific, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 13310-153_d2f8943c-0442-4ddc-a712-5c1c79fed29b 13310-153 HUMAN PRESCRIPTION DRUG Qualaquin Quinine Sulfate CAPSULE ORAL 20050812 NDA NDA021799 AR Scientific Inc. QUININE SULFATE 324 mg/1 Antimalarial [EPC] E 20171231 13340-5624_4e7a3618-3d32-4b77-8a3e-023d4eb65ee6 13340-5624 HUMAN OTC DRUG Throat Coat Menthol PASTILLE ORAL 20050126 OTC MONOGRAPH NOT FINAL part356 Phytoneering Extract Solutions GmbH MENTHOL 2.5 mg/1 E 20171231 13517-110_6158e417-2702-4bd0-e053-2a91aa0a917e 13517-110 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20170224 UNAPPROVED DRUG OTHER e5 Pharma, LLC PHENOBARBITAL 16.2 mg/1 CIV N 20181231 13517-111_6158e417-2702-4bd0-e053-2a91aa0a917e 13517-111 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20170224 UNAPPROVED DRUG OTHER e5 Pharma, LLC PHENOBARBITAL 32.4 mg/1 CIV N 20181231 13517-112_6158e417-2702-4bd0-e053-2a91aa0a917e 13517-112 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20170224 UNAPPROVED DRUG OTHER e5 Pharma, LLC PHENOBARBITAL 64.8 mg/1 CIV N 20181231 13517-113_6158e417-2702-4bd0-e053-2a91aa0a917e 13517-113 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20170224 UNAPPROVED DRUG OTHER e5 Pharma, LLC PHENOBARBITAL 97.2 mg/1 CIV N 20181231 13533-131_3b8eeb90-6af5-4bff-b214-1acd4ea15af3 13533-131 VACCINE Tetanus and Diphtheria Toxoids Adsorbed Tetanus and Diphtheria Toxoids Adsorbed INJECTION INTRAMUSCULAR 20150701 BLA BLA101322 Grifols CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2; 2 [Lf]/.5mL; [Lf]/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient] N 20181231 13533-602_20d8024d-b7e8-4c48-a02f-6f7238ae6c99 13533-602 PLASMA DERIVATIVE THROMBATE III ANTITHROMBIN III (HUMAN) KIT 19911230 BLA BLA103196 GRIFOLS USA, LLC N 20181231 13533-603_20d8024d-b7e8-4c48-a02f-6f7238ae6c99 13533-603 PLASMA DERIVATIVE THROMBATE III ANTITHROMBIN III (HUMAN) KIT 19911230 BLA BLA103196 GRIFOLS USA, LLC N 20181231 13533-613_21e1da7a-a24e-4949-8923-e70f6f490bf8 13533-613 PLASMA DERIVATIVE Plasmanate Plasma Protein Fraction (Human) SOLUTION INTRAVENOUS 19581002 BLA BLA101140 GRIFOLS USA, LLC ALBUMIN HUMAN 2.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 13533-618_9cecb9f3-a123-4051-9dea-d2a39c74c4cf 13533-618 PLASMA DERIVATIVE HYPERRAB S/D RABIES IMMUNE GLOBULIN (HUMAN) INJECTION INTRAMUSCULAR 19960814 BLA BLA101144 GRIFOLS USA, LLC HUMAN RABIES VIRUS IMMUNE GLOBULIN 150 [iU]/mL N 20181231 13533-631_65d07f56-79f5-4dd1-8ded-3687a88770f1 13533-631 PLASMA DERIVATIVE HYPERRHO S/D FULL DOSE RHO(D) IMMUNE GLOBULIN (HUMAN) SOLUTION INTRAMUSCULAR 19960814 BLA BLA101141 GRIFOLS USA, LLC HUMAN RHO(D) IMMUNE GLOBULIN 1500 [iU]/1 Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 13533-634_837a9dc8-28c8-48af-b18b-1620f67c7527 13533-634 PLASMA DERIVATIVE HyperTET S/D Tetanus Immune Globulin (Human) INJECTION INTRAMUSCULAR 19960814 BLA BLA101142 GRIFOLS USA, LLC HUMAN CLOSTRIDIUM TETANI TOXOID IMMUNE GLOBULIN 250 [iU]/mL N 20181231 13533-635_9cd1f1b1-c08c-445d-84bc-367c4640bca2 13533-635 PLASMA DERIVATIVE GAMASTAN S/D IMMUNE GLOBULIN (HUMAN) INJECTION INTRAMUSCULAR 19960814 BLA BLA101134 GRIFOLS USA, LLC HUMAN IMMUNOGLOBULIN G .165 g/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 13533-636_5e516db1-4145-44b5-8152-f884040c1755 13533-636 PLASMA DERIVATIVE HYPERHEP B S/D HEPATITIS B IMMUNE GLOBULIN (HUMAN) INJECTION INTRAMUSCULAR 19961009 BLA BLA101146 GRIFOLS USA, LLC HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 220 [iU]/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] N 20181231 13533-661_b04431ab-dd1f-4bd5-a67e-7e18e39c1168 13533-661 PLASMA DERIVATIVE HYPERRHO S/D MINI-DOSE RHO(D) IMMUNE GLOBULIN (HUMAN) SOLUTION INTRAMUSCULAR 19960814 BLA BLA101141 GRIFOLS USA, LLC HUMAN RHO(D) IMMUNE GLOBULIN 250 [iU]/1 Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 13533-683_2e081a57-052b-4ff3-8cd4-9a2b054da165 13533-683 PLASMA DERIVATIVE Plasbumin Albumin (Human) SOLUTION INTRAVENOUS 19810728 BLA BLA101138 GRIFOLS USA, LLC ALBUMIN HUMAN 10 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 13533-684_c9787b7b-23dc-46e6-9966-92db492eb3d0 13533-684 PLASMA DERIVATIVE Plasbumin Albumin (Human) SOLUTION INTRAVENOUS 19421021 BLA BLA101138 GRIFOLS USA, LLC ALBUMIN HUMAN 5 g/20mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 13533-685_7ac3c83c-8847-48fb-9d8a-2f2cef89e469 13533-685 PLASMA DERIVATIVE Plasbumin Albumin (Human) SOLUTION INTRAVENOUS 19760826 BLA BLA101138 GRIFOLS USA, LLC ALBUMIN HUMAN 2.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 13533-690_caa06a87-3b7b-4250-b435-0d04a3d4559d 13533-690 PLASMA DERIVATIVE Plasbumin Albumin (Human) SOLUTION INTRAVENOUS 19940926 BLA BLA101138 GRIFOLS USA, LLC ALBUMIN HUMAN 2.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 13533-691_586b97e3-77be-4370-ba23-0d1f4045469b 13533-691 PLASMA DERIVATIVE Plasbumin Albumin (Human) SOLUTION INTRAVENOUS 19940926 BLA BLA101138 GRIFOLS USA, LLC ALBUMIN HUMAN 10 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 13533-692_c2341abf-0764-40ea-a2e5-9588a826ca87 13533-692 PLASMA DERIVATIVE Plasbumin Albumin (Human) SOLUTION INTRAVENOUS 19940926 BLA BLA101138 GRIFOLS USA, LLC ALBUMIN HUMAN 5 g/20mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 13533-700_b7dbe931-b17d-4a1a-b053-bae44f4ef3bb 13533-700 PLASMA DERIVATIVE PROLASTIN-C ALPHA-1-PROTEINASE INHIBITOR (HUMAN) KIT 19871202 BLA BLA103174 GRIFOLS USA, LLC N 20181231 13533-701_b7dbe931-b17d-4a1a-b053-bae44f4ef3bb 13533-701 PLASMA DERIVATIVE PROLASTIN-C ALPHA-1-PROTEINASE INHIBITOR (HUMAN) KIT 19871202 BLA BLA103174 GRIFOLS USA, LLC N 20181231 13533-703_b7dbe931-b17d-4a1a-b053-bae44f4ef3bb 13533-703 PLASMA DERIVATIVE PROLASTIN-C ALPHA-1-PROTEINASE INHIBITOR (HUMAN) KIT 19871202 BLA BLA103174 GRIFOLS USA, LLC N 20181231 13533-705_57e956c2-1293-4be3-8758-fb8a7cf34701 13533-705 PLASMA DERIVATIVE Prolastin-C Liquid Alpha1-Proteinase Inhibitor (Human) INJECTION, SOLUTION INTRAVENOUS 19871202 BLA BLA103174 GRIFOLS USA, LLC .ALPHA.1-PROTEINASE INHIBITOR HUMAN 1000 mg/20mL Human alpha-1 Proteinase Inhibitor [EPC],Trypsin Inhibitors [MoA] N 20181231 13533-800_82fd3d40-0366-40f6-a35e-1781e5abe9fa 13533-800 PLASMA DERIVATIVE Gamunex-C Immune Globulin (Human) INJECTION INTRAVENOUS; SUBCUTANEOUS 20101013 BLA BLA125046 GRIFOLS USA, LLC HUMAN IMMUNOGLOBULIN G 10 g/100mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 13537-000_a068bf12-a90e-43ee-b492-c31e25b5a5a0 13537-000 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 CLAIRE 1- BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-001_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-001 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MARRON TOSCANA) - BROWN Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-002_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-002 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD PIMIENTA CALIENTE) - BROWN Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-003_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-003 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD VINO CAUTIVANTE) - RED Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-004_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-004 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSA VIVA) - PINK Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-005_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-005 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CORAL ENSUENO) - RED Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-006_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-006 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROJO GLAM) - RED Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-007_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-007 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CAFE HABANO) - BROWN Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-008_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-008 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FUCSIA VIBRANTE) - PINK Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-009_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-009 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD DURAZNO NUDE) - PINK Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-010_3aa2fe30-92c4-4d82-89d1-b9acf99f31f8 13537-010 HUMAN OTC DRUG CYZONE GIULIA Aluminum sesquichlorohydrate LIQUID TOPICAL 20110419 OTC MONOGRAPH FINAL part350 Ventura Corporation Limited ALUMINUM SESQUICHLOROHYDRATE .17 mL/mL E 20171231 13537-011_0da5028f-027d-401e-8bbb-cbb5ca204e01 13537-011 HUMAN OTC DRUG LBel Effet Parfait Rouge Alissant Octinoxate and Oxybenzone LIPSTICK TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., OCTINOXATE; OXYBENZONE .24; .06 g/4g; g/4g E 20171231 13537-012_764bfb1d-d860-46a5-9120-9cd2b2b9d815 13537-012 HUMAN OTC DRUG CYZONE CY OCTINOXATE and OCTOCRYLENE OINTMENT TOPICAL 20110121 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Limited OCTINOXATE; OCTOCRYLENE .06; .04 g/g; g/g E 20171231 13537-013_764bfb1d-d860-46a5-9120-9cd2b2b9d815 13537-013 HUMAN OTC DRUG CYZONE CY OCTINOXATE and OCTOCRYLENE OINTMENT TOPICAL 20110121 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Limited OCTINOXATE; OCTOCRYLENE .06; .04 g/g; g/g E 20171231 13537-014_764bfb1d-d860-46a5-9120-9cd2b2b9d815 13537-014 HUMAN OTC DRUG CYZONE CY OCTINOXATE and OCTOCRYLENE OINTMENT TOPICAL 20110121 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Limited OCTINOXATE; OCTOCRYLENE .06; .04 g/g; g/g E 20171231 13537-015_764bfb1d-d860-46a5-9120-9cd2b2b9d815 13537-015 HUMAN OTC DRUG CYZONE CY OCTINOXATE and OCTOCRYLENE OINTMENT TOPICAL 20110121 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Limited OCTINOXATE; OCTOCRYLENE .06; .04 g/g; g/g E 20171231 13537-016_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-016 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD NARANJA PROVOCACION) - ORANGE Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-017_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-017 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MELON INTENSE) - PINK Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-018_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-018 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSADO CHIC) - PINK Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-019_0b153b98-72fc-4125-b437-d0fa7fc058c2 13537-019 HUMAN OTC DRUG LBEL COULEUR LUXE ROUGE IRRESISTIBLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-020_8e687625-3c1c-4d25-8932-cf97d19e5587 13537-020 HUMAN OTC DRUG LBEL Couleur Luxe Supreme Laque OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OXYBENZONE .07; .03 mL/mL; mL/mL E 20171231 13537-021_d2f0744c-317a-44c4-b1a7-f23be28e7f12 13537-021 HUMAN OTC DRUG LBEL EFFET PARFAIT OCTINOXATE, OXYBENZONE, and TITANIUM DIOXIDE LIPSTICK TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .03; .008 g/g; g/g; g/g E 20171231 13537-022_57de5149-3025-4753-b084-1be876cb8cd0 13537-022 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL TITANIUM DIOXIDE, OXYBENZONE, ZINC OXIDE, and OCTINOXATE POWDER TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. TITANIUM DIOXIDE; OXYBENZONE; ZINC OXIDE; OCTINOXATE .06; .05; .049; .035 g/g; g/g; g/g; g/g E 20171231 13537-023_906dbbed-59ec-44b0-a595-d67a62452f61 13537-023 HUMAN OTC DRUG EFFET PARFAIT natural finish moisturizing foundation SPF 25 Octinoxate and Titanium Dioxide LOTION TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; TITANIUM DIOXIDE .065; .016 mL/mL; mL/mL E 20171231 13537-024_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-024 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CIRUELA GLAM) - RED Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-025_ac565e8f-4ea5-4a81-a24d-eaff466a0301 13537-025 HUMAN OTC DRUG LBEL REGRESSION JOUR Protective Complex with SPF 15 Facial day normal to dry skin Avobenzone, Ensulizole, Octinoxate, and Oxybenzone CREAM TOPICAL 20120514 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. AVOBENZONE; ENSULIZOLE; OCTINOXATE; OXYBENZONE .02; .01; .075; .02 g/g; g/g; g/g; g/g E 20171231 13537-026_bab857e0-394d-4e26-af70-17e0cac83524 13537-026 HUMAN OTC DRUG LBEL PROTEGE EXPERT Octinoxate, Octisalate, Oxybenzone, and Titanium dioxide LOTION TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .075; .05; .06; .0234 g/mL; g/mL; g/mL; g/mL E 20171231 13537-027_dd5be4e2-fa42-4add-bdb3-a7e27bdf2eb1 13537-027 HUMAN OTC DRUG LBEL PROTEGE EXPERT Ensulizole, Octinoxate, Octisalate, Oxybenzone, and Titanium dioxide LOTION TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. ENSULIZOLE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .03; .075; .05; .06; .039 g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 13537-028_d3ba2700-e939-4eee-b5df-31f75c93327a 13537-028 HUMAN OTC DRUG LBel Protege Expert Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium dioxide CREAM TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .075; .04; .1; .06; .01 g/g; g/g; g/g; g/g; g/g E 20171231 13537-029_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-029 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MAGENTA SWEET) - PURPLE Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-030_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-030 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FRAMBUESA ENCANTO) - RED Octinoxate LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-031_517068e5-4daf-4657-8f88-bd145e6010e0 13537-031 HUMAN OTC DRUG LBEL Hydra Calme SPF 15 Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20110829 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. (San Juan, P.R) OCTINOXATE; OCTISALATE; OXYBENZONE .075; .04; .04 g/mL; g/mL; g/mL E 20171231 13537-032_b95cbc27-afc2-486c-a3ee-38933aad7a58 13537-032 HUMAN OTC DRUG AINNARA Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110923 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-033_4a4ef065-6831-421d-9785-592945752f59 13537-033 HUMAN OTC DRUG ALTHEUS For Men Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110923 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-034_efba0ad0-6770-4e93-9d41-e7df3c9127f2 13537-034 HUMAN OTC DRUG CARDIGAN Roll-On Aluminum Sesquichlorohydrate STICK TOPICAL 20110923 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-035_febae930-324a-4a29-9ed5-abe1628c5651 13537-035 HUMAN OTC DRUG DARIEN Antiperspirant Roll-On Deodorant Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110923 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-036_e7d6e963-61dc-46c1-b81e-89b218f5b5c0 13537-036 HUMAN OTC DRUG ESIKA DANZZIA Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-037_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-037 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g E 20171231 13537-038_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-038 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g E 20171231 13537-039_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-039 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g E 20171231 13537-040_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-040 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g E 20171231 13537-041_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-041 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g E 20171231 13537-042_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-042 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g E 20171231 13537-043_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-043 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g E 20171231 13537-044_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-044 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g E 20171231 13537-045_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-045 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g E 20171231 13537-046_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-046 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g E 20171231 13537-047_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-047 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g E 20171231 13537-048_ecbec6a8-8598-428b-a1e1-ca678ae0cee7 13537-048 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 Titanium Dioxide STICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) TITANIUM DIOXIDE .04 g/g E 20171231 13537-049_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-049 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g E 20171231 13537-050_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-050 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g E 20171231 13537-051_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-051 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g E 20171231 13537-052_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-052 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g E 20171231 13537-053_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-053 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g E 20171231 13537-054_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-054 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g E 20171231 13537-055_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-055 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g E 20171231 13537-056_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-056 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g E 20171231 13537-057_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-057 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g E 20171231 13537-058_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-058 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g E 20171231 13537-059_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-059 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g E 20171231 13537-060_ae986dde-2ea0-43d8-b660-a695436ec75c 13537-060 HUMAN OTC DRUG ESIKA Ultra Softening SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .0182 g/g; g/g E 20171231 13537-061_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-061 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (MARRON GLAMOUR) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-062_d8493cc9-c2ec-4808-aa47-67405295ba7c 13537-062 HUMAN OTC DRUG Esika EXUS Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-063_27978e9c-c623-4f67-979c-d06328160d65 13537-063 HUMAN OTC DRUG ESIKA FLOWERY Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-064_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-064 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO DESEO) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-065_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-065 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO INTRIGANTE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-066_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-066 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO LUJURIA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-067_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-067 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (CORAL CHIC) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-068_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-068 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ENCANTO) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-069_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-069 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (BORGONA SEXY) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-070_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-070 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FUCSIA CAUTIVANTE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-071_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-071 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (GRANATE SEDUCTOR) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-072_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-072 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ROMANTICA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-073_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-073 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (NARANJA PRIMAVERA) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-074_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-074 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FRAMBUESA MANIA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-075_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-075 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA DULZURA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-076_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-076 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (PIMIENTA CALIENTE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-077_1c92023a-0e67-4952-9c17-fdd98467bab6 13537-077 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 Octinoxate and Oxybenzone KIT 20140403 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD E 20171231 13537-078_a068bf12-a90e-43ee-b492-c31e25b5a5a0 13537-078 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 CLAIRE 2- BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-079_a068bf12-a90e-43ee-b492-c31e25b5a5a0 13537-079 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 CLAIRE 3- BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-080_a068bf12-a90e-43ee-b492-c31e25b5a5a0 13537-080 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 CLAIRE 4- BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-081_a068bf12-a90e-43ee-b492-c31e25b5a5a0 13537-081 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 MEDIUM 5- BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-082_a068bf12-a90e-43ee-b492-c31e25b5a5a0 13537-082 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 MEDIUM 6- BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-083_a068bf12-a90e-43ee-b492-c31e25b5a5a0 13537-083 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 MEDIUM 7- BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-084_a068bf12-a90e-43ee-b492-c31e25b5a5a0 13537-084 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 OBSCURE 8- BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-085_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-085 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (MOKA) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-086_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-086 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (ROMANCE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-087_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-087 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (ROSE NATURAL) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-088_c71a5af0-420c-49cf-a28d-46d2224f10cf 13537-088 HUMAN OTC DRUG LBEL Hydra Calme Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTISALATE; OXYBENZONE 2.25; 1.2; 1.2 mg/30mL; mg/30mL; mg/30mL E 20171231 13537-089_c71a5af0-420c-49cf-a28d-46d2224f10cf 13537-089 HUMAN OTC DRUG LBEL Hydra Calme Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTISALATE; OXYBENZONE .075; .04; .04 mg/mL; mg/mL; mg/mL E 20171231 13537-090_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-090 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (ROJO CLASIQUE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-091_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-091 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (ROUGE INTENSE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-092_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-092 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (AMOUR) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-093_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-093 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (CHOCOLAT) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-094_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-094 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (ALMOND) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-095_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-095 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (MALVE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-096_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-096 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (MARRON GLACE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-097_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-097 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (TULIP) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-098_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-098 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (NUDE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-099_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-099 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (LILY BEIGE) - BEIGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-100_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-100 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROSE NATURAL) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-101_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-101 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROJO VIF) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-102_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-102 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (MANDARINE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-103_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-103 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (CAPUCCINO) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-104_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-104 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (VIN) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-105_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-105 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (FUCHSIA INTENSE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-106_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-106 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROUGE BRILLANCE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-107_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-107 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROUGE INTENSE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-108_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-108 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (FUCHSIA BRILLANCE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-109_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-109 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROSE BRILLANCE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-110_29f0150d-79e4-4d74-862e-352c0057e84d 13537-110 HUMAN OTC DRUG CYZONE SUN BY ME Octinoxate, Oxybenzone, Octisalate, and Titanium dioxide LOTION TOPICAL 20110422 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Limited OCTINOXATE; OXYBENZONE; OCTISALATE; TITANIUM DIOXIDE .075; .05; .05; .00948 g/mL; g/mL; g/mL; g/mL E 20171231 13537-111_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-111 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROSE CLASSIQUE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-112_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-112 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (CLAIRE 1) - BEIGE Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE; TITANIUM DIOXIDE .049; .057 g/g; g/g E 20171231 13537-113_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-113 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (CLAIRE 2) - BEIGE Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE; TITANIUM DIOXIDE .049; .057 g/g; g/g E 20171231 13537-114_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-114 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (CLAIRE 4) - BEIGE Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE; TITANIUM DIOXIDE .049; .057 g/g; g/g E 20171231 13537-115_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-115 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (VIOLET POURPRE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-116_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-116 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ORANGE DELIRANT) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-117_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-117 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROSE FEMME) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-118_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-118 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROUGE INTENSE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-119_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-119 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (DORE CHOCOLAT) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-120_86e32f16-b851-4880-8ef3-2f3cfef2cf0a 13537-120 HUMAN OTC DRUG ESIKA IMAGENES Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-121_eb6d5387-ba44-4c48-9b34-a81256ca38f1 13537-121 HUMAN OTC DRUG LBEL Divine Lip Gloss SPF 15 Octinoxate and Oxybenzone LOTION TOPICAL 20111114 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. (San Juan, P.R) OCTINOXATE; OXYBENZONE .075; .03 mL/mL; mL/mL E 20171231 13537-122_2af2c4fe-eefc-4d6f-8087-95b4628a8a09 13537-122 HUMAN OTC DRUG CYZONE Body Manic Aluminum Sesquichlorohydrate LOTION TOPICAL 20111114 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .2 g/mL E 20171231 13537-123_c789fd9b-5e71-480f-bb54-8bd33bef1c4b 13537-123 HUMAN OTC DRUG CYZONE CY Cover Mat Octinoxate and Titanium Dioxide CREAM TOPICAL 20111213 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; TITANIUM DIOXIDE .06; .008 g/g; g/g E 20171231 13537-124_c789fd9b-5e71-480f-bb54-8bd33bef1c4b 13537-124 HUMAN OTC DRUG CYZONE CY Cover Mat Octinoxate and Titanium Dioxide CREAM TOPICAL 20111213 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; TITANIUM DIOXIDE .06; .008 g/g; g/g E 20171231 13537-125_c789fd9b-5e71-480f-bb54-8bd33bef1c4b 13537-125 HUMAN OTC DRUG CYZONE CY Cover Mat Octinoxate and Titanium Dioxide CREAM TOPICAL 20111213 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; TITANIUM DIOXIDE .06; .008 g/g; g/g E 20171231 13537-126_c789fd9b-5e71-480f-bb54-8bd33bef1c4b 13537-126 HUMAN OTC DRUG CYZONE CY Cover Mat Octinoxate and Titanium Dioxide CREAM TOPICAL 20111213 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; TITANIUM DIOXIDE .06; .008 g/g; g/g E 20171231 13537-127_620a4be9-af67-4f5e-8cf2-747117821bf5 13537-127 HUMAN OTC DRUG Cyzone Be Sexy Pyrithione Zinc LOTION TOPICAL 20111213 OTC MONOGRAPH FINAL part358H Ventura Corporation Ltd. PYRITHIONE ZINC .0036 mg/mL E 20171231 13537-128_ffc6eb5a-da91-4b57-bc83-fba1d2bd01ca 13537-128 HUMAN OTC DRUG ESIKA AVENTOUR Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-129_464ba5ee-ef90-4460-b659-8682ef4ac728 13537-129 HUMAN OTC DRUG ESIKA BRAVIO Christian Meier Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-130_72a98634-064c-46a7-99aa-6c7e75b9ea05 13537-130 HUMAN OTC DRUG ESIKA ROMANZI Christian Meier Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-131_dacb8904-2c6b-4914-84fc-075dc17c9145 13537-131 HUMAN OTC DRUG Esika Pulso Christian Meier Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-132_61e5d891-86c8-4fd2-81a3-61a4c6af713f 13537-132 HUMAN OTC DRUG ESIKA SALVAJE Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 mg/mL E 20171231 13537-133_0422116e-2307-4eae-ba2e-c5a0e1d5a868 13537-133 HUMAN OTC DRUG ESIKA STRONG MUSK Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-134_49740eaf-b561-402c-88ec-463ef91e1eff 13537-134 HUMAN OTC DRUG ESIKA VALERUS FOR MEN Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-135_4de8ccf1-d045-486c-bfe9-4d755b320695 13537-135 HUMAN OTC DRUG ESIKA WINNER SPORT Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-136_fc17641f-6e8f-4090-b4a7-f91efb9478c4 13537-136 HUMAN OTC DRUG ESIKA WINNER TONIGHT Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-137_4c522542-f216-4eb0-8327-1603a73cf49f 13537-137 HUMAN OTC DRUG ESIKA ITS YOU Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-138_f6c1ec14-f14d-4c7c-a977-9ee3fd7093e9 13537-138 HUMAN OTC DRUG ESIKA ITS YOU LIVE Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-139_3438acfc-41d6-4a5c-9f09-6ad59c8d3d85 13537-139 HUMAN OTC DRUG ESIKA SECRET MUSK Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-140_0615bc58-6615-4af3-a13c-85548628209d 13537-140 HUMAN OTC DRUG ESIKA VANILLA HOMBRE Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-141_83e69bc3-4652-4459-bfc1-f4d7329bc02d 13537-141 HUMAN OTC DRUG ESIKA VANILLA SCENT Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-142_95ec8aef-349a-4a80-9d00-704219f1d175 13537-142 HUMAN OTC DRUG ESIKA WINNER BLACK Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-143_616b61e0-0680-40d0-92a9-8956c9fb7f77 13537-143 HUMAN OTC DRUG ESIKA VEHEMENCE FOR MEN Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-144_446af6bb-1356-450c-8916-4c1bbba73c78 13537-144 HUMAN OTC DRUG ESIKA FORZE Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 mg/mL E 20171231 13537-145_6dbcb17a-90c4-4fe6-b0b4-e7369961afb5 13537-145 HUMAN OTC DRUG ESIKA VEHEMENCE FOR WOMAN Roll-On Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-146_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-146 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (FUCSIA DESIR) - MAGENTA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-147_cdbf44a7-4c4a-45ff-b1e8-0cdc334d7c3a 13537-147 HUMAN OTC DRUG ESIKA Total Sec Neutral Fragrance 36 ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20120124 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd ALUMINUM SESQUICHLOROHYDRATE .162 g/mL E 20171231 13537-148_92954fd7-301b-4075-8764-25a8430fe7dc 13537-148 HUMAN OTC DRUG LBel EFFET PARFAIT TITANIUM DIOXIDE, OXYBENZONE, and OCTINOXATE POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd TITANIUM DIOXIDE; OXYBENZONE; OCTINOXATE .04425; .03; .04 g/g; g/g; g/g E 20171231 13537-149_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-149 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (MER DE ROSES) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-150_162e9516-8297-4782-a064-57ec823dc473 13537-150 HUMAN OTC DRUG LBel EFFET PARFAIT Loose Extra-Fine Portable TITANIUM DIOXIDE, OXYBENZONE, and OCTINOXATE POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd TITANIUM DIOXIDE; OXYBENZONE; OCTINOXATE .035; .03; .03 g/g; g/g; g/g E 20171231 13537-151_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-151 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROUGE PROVOCATION) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-152_3d0e3123-a464-4af1-ae3d-8d44ad3d7e9e 13537-152 HUMAN OTC DRUG ESIKA NATURAL CARE Octinoxate and Oxybenzone CREAM TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd OCTINOXATE; OXYBENZONE .075; .045 g/g; g/g E 20171231 13537-153_065f261c-4cdf-4c98-abce-66668713b2f5 13537-153 HUMAN OTC DRUG ESIKA PERFECT SUN Avobenzone, Octisalate, Octocrylene, and Oxybenzone LIQUID TOPICAL 20120124 OTC MONOGRAPH FINAL part352 Ventura Corporation, Ltd. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .1; .06 g/mL; g/mL; g/mL; g/mL E 20171231 13537-154_9db5721c-2014-4a3a-b199-8aa88840145c 13537-154 HUMAN OTC DRUG ESIKA MEN MAXIMUM STRENGTH PYRITHIONE ZINC LIQUID TOPICAL 20120124 OTC MONOGRAPH FINAL part358H Ventura Corporation Ltd PYRITHIONE ZINC .00528 g/mL E 20171231 13537-155_91282cc9-1792-4712-807f-fe2f8e53232f 13537-155 HUMAN OTC DRUG Cyzone SUN BY ME Sunblock SPF 50 OCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, TITANIUM DIOXIDE, and ENSULIZOLE CREAM TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd OCTINOXATE; OCTOCRYLENE; OXYBENZONE; OCTISALATE; TITANIUM DIOXIDE; ENSULIZOLE .075; .07; .06; .05; .0468; .03 g/g; g/g; g/g; g/g; g/g; g/g E 20171231 13537-156_15ca348a-baf0-49c1-95be-b737bcb836cf 13537-156 HUMAN OTC DRUG Esika TOTAL SEC ULTRA FRESH ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20120124 OTC MONOGRAPH FINAL part350 Ventura Corporation, Ltd. ALUMINUM SESQUICHLOROHYDRATE .0162 g/mL E 20171231 13537-157_e8993a1e-d0d0-4120-997d-dfe8da088b59 13537-157 HUMAN OTC DRUG ESIKA Total Sec Delicate Skin ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20120124 OTC MONOGRAPH FINAL part350 Ventura Corporation, Ltd. ALUMINUM SESQUICHLOROHYDRATE .162 g/mL E 20171231 13537-158_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-158 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROSE TENTATION) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-159_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-159 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROSE DELICAT) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-160_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-160 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (CARMINE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-161_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-161 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (NOBLESSE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-162_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-162 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (MALBEC) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-163_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-163 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (AMANDIER) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-164_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-164 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (SOBRIETE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-165_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-165 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (FIANCEE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-166_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-166 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROMANCE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-167_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-167 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROSE FUCSIA) - MAGENTA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-168_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-168 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (MIEL ECHANTER) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-169_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-169 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (BLUSH CURE) - PINK Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-170_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-170 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (GET WELL PEACH) - PINK Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-171_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-171 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (PURE OXYGEN) - BEIGE Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-172_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-172 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (SAND LIFE) - YELLOW Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-173_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-173 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (CHOCO THERAPY) - BROWN Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-174_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-174 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (INTENSIVE RED) - RED Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-175_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-175 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (DR. ROSE) - PINK Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-176_fd25b245-ff4a-4b8f-b03f-83f3bca025ce 13537-176 HUMAN OTC DRUG ESIKA Silk Skin Face SPF 9 Octinoxate and Titanium Dioxide POWDER TOPICAL 20161031 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .02; .044 g/g; g/g E 20171231 13537-177_fe2e87bf-e30c-44b8-9bc8-b0ef9207e029 13537-177 HUMAN OTC DRUG LBEL DEFENSE 365 oil-free daily protective facial SPF 50 Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20161031 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .05; .07; .05; .04; .0624; .0392 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 13537-178_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-178 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (MANDARINE) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-179_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-179 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (VIN) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-180_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-180 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (FRESA TENTACION) - RED Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-181_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-181 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (CAFE MISTERIO) - BROWN Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-182_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-182 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (ROSA DESEO) - RED Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-183_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-183 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (DURAZNO AMOR) - ORANGE Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-184_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-184 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (ROSA GOLOSA) - PINK Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-185_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-185 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (CORAL SEDUCTOR) - PINK Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-186_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-186 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (CEREZA SEXY) - PINK Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-187_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-187 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 6) - BEIGE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-188_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-188 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 5) - BEIGE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-189_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-189 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 4) - BEIGE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-190_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-190 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 3) - BEIGE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-191_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-191 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 2) - BEIGE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-192_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-192 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 1) - BEIGE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-193_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-193 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 6) - ROSE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-194_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-194 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 5) - ROSE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-195_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-195 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 4) - ROSE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-196_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-196 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 3) - ROSE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-197_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-197 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 2) - ROSE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-198_70dd741b-bce1-4075-b3a7-03d4c61999af 13537-198 HUMAN OTC DRUG ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 1) - ROSE Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-199_d8c0d739-fedf-497c-9967-21bd5b57f772 13537-199 HUMAN OTC DRUG ESIKA NATURAL CARE CONCHA DE NACAR AND ROSA MOSQUETA facial FPS 15 Octinoxate and Oxybenzone CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .045 g/g; g/g E 20171231 13537-200_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-200 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 1) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL E 20171231 13537-201_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-201 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 2) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL E 20171231 13537-202_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-202 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 3) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL E 20171231 13537-203_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-203 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 4) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL E 20171231 13537-204_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-204 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 5) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL E 20171231 13537-205_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-205 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 6) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL E 20171231 13537-206_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-206 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 7) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL E 20171231 13537-207_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-207 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 8) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL E 20171231 13537-208_c8e141bf-bc98-495f-abd2-11008f5589c9 13537-208 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 9) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/mL E 20171231 13537-209_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-209 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Beige 1) - BEIGE Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g E 20171231 13537-210_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-210 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Beige 2) - BEIGE Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g E 20171231 13537-211_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-211 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Beige 3) - BEIGE Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g E 20171231 13537-212_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-212 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Beige 4) - BEIGE Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g E 20171231 13537-213_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-213 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Beige 5) - BEIGE Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g E 20171231 13537-214_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-214 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Beige 6) - BEIGE Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g E 20171231 13537-215_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-215 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Rosa 1) - PINK Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g E 20171231 13537-216_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-216 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Rosa 2) - PINK Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g E 20171231 13537-217_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-217 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Rosa 3) - PINK Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g E 20171231 13537-218_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-218 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Rosa 4) - PINK Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g E 20171231 13537-219_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-219 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Rosa 5) - PINK Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g E 20171231 13537-220_11ff77dd-09ef-475a-99fb-db685389c6e6 13537-220 HUMAN OTC DRUG LBel Effet Parfait Rouge Volumesse Octinoxate and Oxybenzone LIPSTICK TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., OCTINOXATE; OXYBENZONE .2688; .0896 g/4g; g/4g E 20171231 13537-221_e8fad5e8-2270-48ca-8ddb-45b480577c7f 13537-221 HUMAN OTC DRUG ESIKA PERFECT SKIN COVERAGE CONCEALER SPF 17 (Rosa 6) - PINK Titanium Dioxide STICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE .04 g/g E 20171231 13537-222_34efefdd-923c-46a2-b218-bf9d25b38856 13537-222 HUMAN OTC DRUG Cyzone Rock You Aluminum sesquichlorohydrate LIQUID TOPICAL 20111108 OTC MONOGRAPH FINAL part350 Ventura Corporation Limited ALUMINUM SESQUICHLOROHYDRATE 8.5 g/50mL E 20171231 13537-224_497b3c05-d201-4c65-b76a-eb82e12a2926 13537-224 HUMAN OTC DRUG ESIKA PROTECTOR AGAINST SOLAR RAYS FOR CHILDREN, FACE AND BODY SPF 50 Ensulizole, Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .03; .075; .05; .07; .06; .046 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 13537-226_c7087e21-9827-48ae-a3e6-8d0f73b5755e 13537-226 HUMAN OTC DRUG LBEL LIP MOISTURIZER SPF 18 Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .03; .08 g/g; g/g; g/g E 20171231 13537-230_f1107067-ec96-4c76-9812-fa3ad7d196ce 13537-230 HUMAN OTC DRUG LBel Effet Parfit Octinoxate LOTION TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., OCTINOXATE 2.1 g/30mL E 20171231 13537-236_c809fa7a-c346-4f8c-93fd-85ba6a3ef5b7 13537-236 HUMAN OTC DRUG ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 Octinoxate KIT 20150515 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD E 20171231 13537-237_1de085f7-dee6-4a0c-991f-4f4511cdbd4e 13537-237 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (CLAIRE 3) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150817 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 13537-238_1de085f7-dee6-4a0c-991f-4f4511cdbd4e 13537-238 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (CLAIRE 4) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150817 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 13537-239_1de085f7-dee6-4a0c-991f-4f4511cdbd4e 13537-239 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (MEDIUM 5) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150817 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 13537-240_80943940-f2b2-4589-8b16-ff202240fb7d 13537-240 HUMAN OTC DRUG LBEL EFFET PARFAIT OCTINOXATE and OXYBENZONE POWDER TOPICAL 20100816 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R.) OCTINOXATE; OXYBENZONE .075; .02 g/g; g/g E 20171231 13537-241_4ada0382-be46-4796-9a67-ffdeda74907d 13537-241 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 1) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-242_4ada0382-be46-4796-9a67-ffdeda74907d 13537-242 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 2) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-243_4ada0382-be46-4796-9a67-ffdeda74907d 13537-243 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 3) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-244_4ada0382-be46-4796-9a67-ffdeda74907d 13537-244 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 4) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-245_4ada0382-be46-4796-9a67-ffdeda74907d 13537-245 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 5) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-246_4ada0382-be46-4796-9a67-ffdeda74907d 13537-246 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 6) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-247_4ada0382-be46-4796-9a67-ffdeda74907d 13537-247 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 7) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-248_4ada0382-be46-4796-9a67-ffdeda74907d 13537-248 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-249_4ada0382-be46-4796-9a67-ffdeda74907d 13537-249 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 9) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-250_db7c5e24-7ccc-4eda-9c6e-b2bc4d6e2e2b 13537-250 HUMAN OTC DRUG LBel Effet Parfit Zinc oxide LOTION TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .48 g/30mL E 20171231 13537-251_4ada0382-be46-4796-9a67-ffdeda74907d 13537-251 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 6B) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-252_4ada0382-be46-4796-9a67-ffdeda74907d 13537-252 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8A) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-253_4ada0382-be46-4796-9a67-ffdeda74907d 13537-253 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8B) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-254_4ada0382-be46-4796-9a67-ffdeda74907d 13537-254 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8C) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-255_4ada0382-be46-4796-9a67-ffdeda74907d 13537-255 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 10) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-256_4ada0382-be46-4796-9a67-ffdeda74907d 13537-256 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (DORE 6) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-257_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-257 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 1) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g E 20171231 13537-258_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-258 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 2) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g E 20171231 13537-259_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-259 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 3) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g E 20171231 13537-260_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-260 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 4) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g E 20171231 13537-261_c5dc0cbd-4b27-43dd-ab25-896c012a439a 13537-261 HUMAN OTC DRUG Supremacie NX Jour Ensulizole, Homosalate, Octinoxate, and Oxybenzone CREAM TOPICAL 20100219 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation, LTDA ENSULIZOLE; HOMOSALATE; OCTINOXATE; OXYBENZONE .001; .001; .00375; .002 g/5g; g/5g; g/5g; g/5g E 20171231 13537-262_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-262 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 6) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g E 20171231 13537-263_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-263 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 7) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g E 20171231 13537-264_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-264 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (OBSCURE 8) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g E 20171231 13537-265_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-265 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (OBSCURE 9) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g E 20171231 13537-266_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-266 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 1) - BEIGE Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL E 20171231 13537-267_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-267 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 2) - BEIGE Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL E 20171231 13537-268_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-268 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 3)- BEIGE Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL E 20171231 13537-269_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-269 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 4) - BEIGE Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL E 20171231 13537-270_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-270 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 5) - BROWN Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL E 20171231 13537-271_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-271 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 6) - BROWN Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL E 20171231 13537-272_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-272 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 7) - BROWN Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL E 20171231 13537-273_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-273 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 8) - BROWN Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL E 20171231 13537-274_b48bc642-2c95-4ed8-9ac9-07bd1b810dc6 13537-274 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 9) - BROWN Zinc Oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE .016 g/mL E 20171231 13537-275_97cd7865-4cef-4561-86dd-e0429dbd50a4 13537-275 HUMAN OTC DRUG ESIKA Silk Skin SPF 9 (translucido) - BEIGE Octinoxate and Titanium Dioxide POWDER TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .02; .044 g/g; g/g E 20171231 13537-276_97cd7865-4cef-4561-86dd-e0429dbd50a4 13537-276 HUMAN OTC DRUG ESIKA Silk Skin SPF 9 (terracota) - BEIGE Octinoxate and Titanium Dioxide POWDER TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .02; .044 g/g; g/g E 20171231 13537-277_9e47161d-96ba-471f-8573-edb456612cd2 13537-277 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (BORGONA SEXY) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-278_9e47161d-96ba-471f-8573-edb456612cd2 13537-278 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (CAFE MOCA) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-280_9e47161d-96ba-471f-8573-edb456612cd2 13537-280 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (FUCSIA CAUTIVANTE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-281_9e47161d-96ba-471f-8573-edb456612cd2 13537-281 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (FUCSIA GLAM) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-282_9e47161d-96ba-471f-8573-edb456612cd2 13537-282 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (GRANATE SEDUCTOR) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-283_9e47161d-96ba-471f-8573-edb456612cd2 13537-283 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (MAGENTA TRAVIESA) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-284_9e47161d-96ba-471f-8573-edb456612cd2 13537-284 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (MARRON GLAMOUR) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-285_9e47161d-96ba-471f-8573-edb456612cd2 13537-285 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (MORADO EXUBERANTE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-286_9e47161d-96ba-471f-8573-edb456612cd2 13537-286 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (NARANJA PRIMAVERA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-287_9e47161d-96ba-471f-8573-edb456612cd2 13537-287 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROJO DESEO) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-288_9e47161d-96ba-471f-8573-edb456612cd2 13537-288 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROJO INTRIGANTE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-289_9e47161d-96ba-471f-8573-edb456612cd2 13537-289 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROJO LUJURIA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-290_9e47161d-96ba-471f-8573-edb456612cd2 13537-290 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROSA DIVA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-291_9e47161d-96ba-471f-8573-edb456612cd2 13537-291 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROSA ENCANTO) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-292_9e47161d-96ba-471f-8573-edb456612cd2 13537-292 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROSA ESPLENDOR) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-293_9e47161d-96ba-471f-8573-edb456612cd2 13537-293 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROSA ROMANTICA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-294_9e47161d-96ba-471f-8573-edb456612cd2 13537-294 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (CEREZA HECHIZO) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-295_9e47161d-96ba-471f-8573-edb456612cd2 13537-295 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (FRAMBUESA MANIA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-296_9e47161d-96ba-471f-8573-edb456612cd2 13537-296 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (ROSA DULZURA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-297_9e47161d-96ba-471f-8573-edb456612cd2 13537-297 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (PIMIENTA CALIENTE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-298_5a7e90d6-5692-4e0f-99c1-94f311dad88a 13537-298 HUMAN OTC DRUG LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 5) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD OCTINOXATE .045 g/g E 20171231 13537-299_4ada0382-be46-4796-9a67-ffdeda74907d 13537-299 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 6A) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 13537-300_383c5b05-b1ce-4915-af8d-4e7ca45adb2c 13537-300 HUMAN OTC DRUG Cyzone better lips balm Octinoxate, Oxybenzone, and Zinc Oxide LIPSTICK TOPICAL 20110228 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. OCTINOXATE; OXYBENZONE; ZINC OXIDE 70; 20; 10 mg/g; mg/g; mg/g E 20171231 13537-301_240f3cbb-c4ce-4a40-9d08-4001f9893369 13537-301 HUMAN OTC DRUG Cyzone Trax Coolture Dermo Cool Pyrithione zinc LIQUID TOPICAL 20100815 OTC MONOGRAPH FINAL part358H VENTURA CORPORATION LTDA., PYRITHIONE ZINC 15 g/300mL E 20171231 13537-302_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-302 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (FUCSIA SENSUAL) - PINK Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-303_498ee34c-a160-4d17-867b-4d9bc49314ca 13537-303 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-304_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-304 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (ROJO PASION) - RED Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-305_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-305 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL E 20171231 13537-306_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-306 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL E 20171231 13537-307_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-307 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL E 20171231 13537-308_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-308 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL E 20171231 13537-309_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-309 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL E 20171231 13537-310_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-310 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL E 20171231 13537-311_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-311 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL E 20171231 13537-312_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-312 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL E 20171231 13537-313_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-313 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL E 20171231 13537-314_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-314 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL E 20171231 13537-315_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-315 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL E 20171231 13537-316_fdc926fe-0aac-44f6-b687-b4980f5027f4 13537-316 HUMAN OTC DRUG ESIKA Hydro-Nutrative Foundation SPF 13 Octinoxate and Oxybenzone LOTION TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .05; .02 mg/mL; mg/mL E 20171231 13537-317_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-317 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g E 20171231 13537-318_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-318 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g E 20171231 13537-319_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-319 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g E 20171231 13537-320_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-320 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g E 20171231 13537-321_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-321 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g E 20171231 13537-322_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-322 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g E 20171231 13537-323_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-323 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g E 20171231 13537-324_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-324 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g E 20171231 13537-325_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-325 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g E 20171231 13537-326_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-326 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g E 20171231 13537-327_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-327 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g E 20171231 13537-328_d6c64fef-cbe6-4ccd-92d4-803463c61be2 13537-328 HUMAN OTC DRUG ESIKA Hydrated Face Makeup Foundation SPF 15 OCTINOXATE POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE .06 g/g E 20171231 13537-329_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-329 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-330_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-330 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-331_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-331 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-332_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-332 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-333_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-333 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-334_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-334 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-335_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-335 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-336_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-336 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-337_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-337 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-338_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-338 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-339_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-339 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-340_da7ce050-9728-4e54-8aa9-a0502aceef72 13537-340 HUMAN OTC DRUG ESIKA 3-in-1 Pro Makeup Foundation SPF 20 Octinoxate, Oxybenzone, and Titanium Dioxide POWDER TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .02; .02 g/g; g/g; g/g E 20171231 13537-341_1b7b4e9b-b2a0-4960-b2c4-a725243f27d4 13537-341 HUMAN OTC DRUG ESIKA Men Effective Control Pyrithione Zinc LIQUID TOPICAL 20110517 OTC MONOGRAPH FINAL part358H Ventura Corporation (San Juan, P.R) PYRITHIONE ZINC .0036 mg/mL E 20171231 13537-342_8c2d556d-adaa-401b-a7cb-7fe07e96875f 13537-342 HUMAN OTC DRUG ESIKA Men Multi-Action 2-in-1 Pyrithione Zinc LIQUID TOPICAL 20110517 OTC MONOGRAPH FINAL part358H Ventura Corporation (San Juan, P.R) PYRITHIONE ZINC .011 mg/mL E 20171231 13537-343_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-343 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g E 20171231 13537-344_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-344 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g E 20171231 13537-345_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-345 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g E 20171231 13537-346_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-346 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g E 20171231 13537-347_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-347 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g E 20171231 13537-348_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-348 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g E 20171231 13537-349_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-349 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g E 20171231 13537-350_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-350 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g E 20171231 13537-351_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-351 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g E 20171231 13537-352_8bd62efa-4839-4dd9-816c-5f7a20e615e9 13537-352 HUMAN OTC DRUG ESIKA Maximum Color SPF 18 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g E 20171231 13537-353_0ec8a72b-c0ca-4210-ac5d-14139563b670 13537-353 HUMAN OTC DRUG ESIKA Vital With Active Z 2-in-1 Dandruff Control Pyrithione Zinc LIQUID TOPICAL 20110517 OTC MONOGRAPH FINAL part358H Ventura Corporation (San Juan, P.R) PYRITHIONE ZINC .0034 mg/mL E 20171231 13537-354_96e1af13-e5a8-48c9-95a5-ab705566d9da 13537-354 HUMAN OTC DRUG Esika Silk Skin Translucido OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20110724 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; TITANIUM DIOXIDE .02; .044 g/g; g/g E 20171231 13537-355_96e1af13-e5a8-48c9-95a5-ab705566d9da 13537-355 HUMAN OTC DRUG Esika Silk Skin Terracota OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20110724 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; TITANIUM DIOXIDE .02; .044 g/g; g/g E 20171231 13537-356_02ba31a3-df90-4aa8-904f-ab24c6bc82f2 13537-356 HUMAN OTC DRUG Cyzone Express Your Face Octinoxate and Oxybenzone CREAM TOPICAL 20110527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .055; .04 g/g; g/g E 20171231 13537-357_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-357 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (TEA ROSE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-358_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-358 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (FRENESIE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-359_156122c9-649f-4d7a-b71d-42fe937bf860 13537-359 HUMAN OTC DRUG CYZONE BLUE AND BLUE FOR HER Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110527 OTC MONOGRAPH FINAL part350 Ventura Corporation (San Juan, P.R) ALUMINUM SESQUICHLOROHYDRATE .17 mL/mL E 20171231 13537-360_88945b2c-eaac-4856-b774-1cc588053590 13537-360 HUMAN OTC DRUG CYZONE BLUE AND BLUE FOR HIM Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110527 OTC MONOGRAPH FINAL part350 Ventura Corporation (San Juan, P.R) ALUMINUM SESQUICHLOROHYDRATE .17 mL/mL E 20171231 13537-361_0503c196-a28d-44ef-95ca-86d73a1f8ab6 13537-361 HUMAN OTC DRUG CYZONE GIRLINK Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110527 OTC MONOGRAPH FINAL part350 Ventura Corporation (San Juan, P.R) ALUMINUM SESQUICHLOROHYDRATE .17 mL/mL E 20171231 13537-362_a38898e8-c86e-4018-a386-fba649701ac0 13537-362 HUMAN OTC DRUG CYZONE NITRO DESODORANTE ANTITRANSPIRANTE ROLL ON Aluminum Sesquichlorohydrate LIQUID TOPICAL 20110527 OTC MONOGRAPH FINAL part350 Ventura Corporation (San Juan, P.R) ALUMINUM SESQUICHLOROHYDRATE .17 mL/mL E 20171231 13537-363_cb0de263-166f-4688-a85d-8f7f1418cf95 13537-363 HUMAN OTC DRUG ESIKA Perfect Sun Kids ENSULIZOLE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20110530 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .03; .075; .05; .07; .6; .0468 g/g; g/g; g/g; g/g; g/g; g/g E 20171231 13537-364_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-364 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g E 20171231 13537-365_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-365 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g E 20171231 13537-366_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-366 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g E 20171231 13537-367_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-367 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g E 20171231 13537-368_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-368 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g E 20171231 13537-369_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-369 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g E 20171231 13537-370_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-370 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g E 20171231 13537-371_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-371 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g E 20171231 13537-372_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-372 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g E 20171231 13537-373_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-373 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g E 20171231 13537-374_e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d 13537-374 HUMAN OTC DRUG ESIKA Core Sensations OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation (San Juan, P.R) OCTINOXATE; OXYBENZONE .065; .02 g/g; g/g E 20171231 13537-375_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-375 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (RICHE PINK) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-376_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-376 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (RED EXTASSY) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-377_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-377 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (FUCSIA) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-378_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-378 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (SOLEIL) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-379_9e47161d-96ba-471f-8573-edb456612cd2 13537-379 HUMAN OTC DRUG ESIKA Extreme Moisturizing SPF 16 (CORAL CHIC) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-380_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-380 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (TERRE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-381_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-381 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (CHERRY BLOSSOM) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-382_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-382 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (VIN AMANT) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-383_bbf24f8a-5c12-42b9-a7a8-9a94d56d19ea 13537-383 HUMAN OTC DRUG LBEL Defense Total broad spectrum SPF 50plus sunscreen for face and body Avobenzone, Homosalate, and Octocrylene LOTION TOPICAL 20150522 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; HOMOSALATE; OCTOCRYLENE .03; .1; .08 g/mL; g/mL; g/mL E 20171231 13537-386_5022f409-75b1-4931-85f7-d8e2adbe7ee1 13537-386 HUMAN OTC DRUG NATURAL CARE CONCHA DE NACAR and ROSA MOSQUETA CREMA FACIAL FPS 15 PARA UNA APARIENCIA MAS CLARA FM OCTINOXATE and OXYBENZONE CREAM TOPICAL 20151022 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .045 g/g; g/g E 20171231 13537-387_d4ba2307-39df-41d2-aec8-b8bacb0b7d12 13537-387 HUMAN OTC DRUG Perfect Sun Kids Sunscreen protector against solar rays for children, face and body SPF 50 FM Ensulizole, Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20151022 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .03; .075; .05; .07; .06; .047 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 13537-400_ff56bc19-d229-4169-94ba-c9d62b1b9831 13537-400 HUMAN OTC DRUG Cyzone Be Sexy BS Tech Zinc Pyrithione And Silicones Pyrithione Zinc LOTION TOPICAL 20111213 OTC MONOGRAPH FINAL part358H Ventura Corporation Ltd. PYRITHIONE ZINC .0036 mg/mL E 20171231 13537-401_1369a773-beb9-4ad3-86fa-3f74118d9694 13537-401 HUMAN OTC DRUG Cyzone Trax Coolture Dermo Cool Aluminum sesquichlorohydrate LIQUID TOPICAL 20100815 OTC MONOGRAPH FINAL part350 VENTURA CORPORATION LTDA. ALUMINUM SESQUICHLOROHYDRATE 10 g/50mL E 20171231 13537-402_38b1a1b0-a33d-404c-8214-b9cbf57a478c 13537-402 HUMAN OTC DRUG LBEL UV DEFENSE 365 Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20110829 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. (San Juan, P.R) HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .05; .07; .05; .04; .0624; .0388 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 13537-403_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-403 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (CLAIRE 3) - BEIGE Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE; TITANIUM DIOXIDE .049; .057 g/g; g/g E 20171231 13537-404_7d3d469b-73f4-4516-9a5a-524698888c6f 13537-404 HUMAN OTC DRUG LBEL Dermo Clarite Clarifying and Moisturizing with SPF 30 Avobenzone, Ensulizole, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111213 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .03; .05; .05; .06 g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 13537-405_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-405 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (MEDIUM 5) - BROWN Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE; TITANIUM DIOXIDE .049; .057 g/g; g/g E 20171231 13537-406_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-406 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (MEDIUM 6) - BROWN Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE; TITANIUM DIOXIDE .049; .057 g/g; g/g E 20171231 13537-407_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-407 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (MEDIUM 7) - BROWN Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE; TITANIUM DIOXIDE .049; .057 g/g; g/g E 20171231 13537-408_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-408 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (OBSCURE 8) - BROWN Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE; TITANIUM DIOXIDE .049; .057 g/g; g/g E 20171231 13537-409_8ec6969e-3a81-4cd9-819d-d7cc97b68c6b 13537-409 HUMAN OTC DRUG LBEL EFFET PARFAIT Polvos Compactos de Larga Duracion para rostro FPS 15 /Long Lasting Compact SPF 15 (OBSCURE 9) - BROWN Zinc Oxide and Titanium Dioxide POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE; TITANIUM DIOXIDE .049; .057 g/g; g/g E 20171231 13537-410_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-410 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (MARRON ILLIMITE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-411_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-411 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (CHOCOLAT MAJESTIC) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-412_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-412 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (CORAIL MAXIMUM) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-413_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-413 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (FUCSIA SPLENDIDE) - MAGENTA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-414_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-414 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROUGE PRODIGEUX) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-415_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-415 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROUGE GRANDOISE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-416_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-416 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROSE CHAMPAGNE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-417_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-417 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROSE DAMOUR) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-418_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-418 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (ROUGE RUBI) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-419_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-419 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (SAUMON ESSENTIEL) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-420_b23d5fa1-de9b-408a-aa56-3af65d835f45 13537-420 HUMAN OTC DRUG LBEL Couleur Luxe Rouge Amplifier XP amplifying SPF 15 (BOURGOGNE VIF) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-421_d63b13c9-1bd6-4a48-85f7-bb27666a0d31 13537-421 HUMAN OTC DRUG ESIKA MOMENTOS Libertad Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-422_3eafe939-8cba-456c-a0d3-fdacfd9bdc19 13537-422 HUMAN OTC DRUG ESIKA ELANIE Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-423_eb81fc06-f1b5-4b52-a31a-24260828ab45 13537-423 HUMAN OTC DRUG ESIKA EXPRESSION Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20111213 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .17 g/mL E 20171231 13537-424_3a01ecc4-c9ec-4ea5-a5fa-596243a8a607 13537-424 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (NUDE INTIME) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 13537-425_741fd278-d4b2-4cad-85f5-f0440d22c1e7 13537-425 HUMAN OTC DRUG LBEL DRY EFFECT 48 ROLL-ON Aluminum Sesquichlorohydrate LIQUID TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd. ALUMINUM SESQUICHLOROHYDRATE .18 g/mL E 20171231 13537-426_9122ddf2-99a7-4150-bea1-c2acfac0a2d4 13537-426 HUMAN OTC DRUG LBEL HOMME ANTIDANDRUFF Pyrithione Zinc SHAMPOO TOPICAL 20120120 OTC MONOGRAPH FINAL part358H Ventura Corporation Ltd PYRITHIONE ZINC .00336 g/mL E 20171231 13537-427_288b1855-af20-4d47-adb8-ad8c8c81bb97 13537-427 HUMAN OTC DRUG LBEL DRY EFFECT 48 ALUMINUM CHLOROHYDRATE AEROSOL, SPRAY TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Ventura Corporation Ltd ALUMINUM CHLOROHYDRATE .24 g/mL E 20171231 13537-428_7fffe85d-18fd-4084-bedb-4c1209bacd7b 13537-428 HUMAN OTC DRUG LBEL Effet Parfait maximum comfort and long-lasting foundation spf 10 Zinc Oxide LOTION TOPICAL 20120210 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation Ltd. ZINC OXIDE .0157 g/mL E 20171231 13537-429_0eb84e4a-3045-45d5-9c6c-21451962ca62 13537-429 HUMAN OTC DRUG CYZONE XPRESS YOUR BODY Aluminum Sesquichlorohydrate LIQUID TOPICAL 20120608 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .2 g/mL E 20171231 13537-430_d824f125-45f3-4096-aecc-76467482ba08 13537-430 HUMAN OTC DRUG CYZONE XPRESS YOUR BODY Aluminum Sesquichlorohydrate LIQUID TOPICAL 20120608 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .2 g/mL E 20171231 13537-431_e82a4522-6688-4512-997b-643c769aaf05 13537-431 HUMAN OTC DRUG CYZONE XPRESS YOUR BODY Sensitive Aluminum Sesquichlorohydrate LIQUID TOPICAL 20120608 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .2 g/mL E 20171231 13537-432_bfaef6ff-f605-4ff9-9006-2cc44d48e0ca 13537-432 HUMAN OTC DRUG CYZONE CY PERLIPS Labial Hidratante con perlas de luz y FPS 20 Octinoxate and Oxybenzone CREAM TOPICAL 20120713 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g E 20171231 13537-433_692ca820-02d3-4008-a6d4-d0ee158731c8 13537-433 HUMAN OTC DRUG CYZONE CY SOLUXION desmanchadora FPS 15 Octinoxate and Oxybenzone CREAM TOPICAL 20120713 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .075; .045 g/g; g/g E 20171231 13537-434_928b87c9-da1d-4633-a52f-b0d29642eeef 13537-434 HUMAN OTC DRUG LBEL EFFET PARFAIT Signs of age appearance minimizer foundation SPF 20 Octinoxate and Titanium Dioxide LOTION TOPICAL 20120914 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; TITANIUM DIOXIDE .07; .024 g/mL; g/mL E 20171231 13537-435_b82ef368-8abd-47cf-8a63-40fc66b84bf6 13537-435 HUMAN OTC DRUG CYZONE SUN BY ME FACE SCREEN FPS 50 AMPLIO ESPECTRO Octinoxate, Octocrylene, Oxybenzone, Octisalate, Titanium Dioxide, and Ensulizole CREAM TOPICAL 20120914 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; OCTISALATE; TITANIUM DIOXIDE; ENSULIZOLE .075; .07; .06; .05; .468; .03 g/g; g/g; g/g; g/g; g/g; g/g E 20171231 13537-436_ec45b9a5-94e1-4965-98e6-12d919e49eb1 13537-436 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20120914 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-437_c8a8893b-0e0d-49c6-bdad-19f9f43fc343 13537-437 HUMAN OTC DRUG esika HIGHWAY Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130201 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-438_3c94bf7f-1faa-4327-a7be-ed84946fd04f 13537-438 HUMAN OTC DRUG esika D ARIEN CLASS Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130201 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-439_e1dac717-a94d-417d-97f1-c0414ff62c8f 13537-439 HUMAN OTC DRUG esika BEAUTY RED Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130201 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-440_d62bee35-45db-4f74-b7f7-3697e719d4db 13537-440 HUMAN OTC DRUG esika SPECIAL Roll-on Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130215 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-441_40868e7e-0f20-4be9-b570-391b765a7a99 13537-441 HUMAN OTC DRUG esika MEN Control Fresh Deodorant and Antiperspirant Aluminum Chlorohydrate LIQUID TOPICAL 20121204 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM CHLOROHYDRATE .045 g/mL E 20171231 13537-442_4d4265eb-7fd5-4e3c-9212-d5832bbbba4d 13537-442 HUMAN OTC DRUG esika Maximum Color Lipstick SPF 18 OCTINOXATE and Oxybenzone LIPSTICK TOPICAL 20121206 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .073; .0165 g/g; g/g E 20171231 13537-443_3bd7c666-3e6f-4828-9ea7-c2bdc9b2fdbe 13537-443 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (MOKA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-444_060cde89-bd6f-4fb3-ba3b-d62ac7ec04d3 13537-444 HUMAN OTC DRUG LBEL LEDERM 35plus Jour SPF 15 Facial Treatment Against First Signs of Aging Day - Oily Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g E 20171231 13537-445_a2d166f7-69ae-42e5-9f3c-46c34ec0f739 13537-445 HUMAN OTC DRUG LBEL LEDERM 35plus Jour SPF 15 Facial Treatment Against First Signs of Aging Day - Normal to Dry Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g N 20181231 13537-446_d4b3adc7-bef7-44fa-ba11-c40f23b7fbd5 13537-446 HUMAN OTC DRUG LBEL LEDERM 45plus Jour SPF 15 Facial Treatment Against Noticeable Signs of Aging Day - Oily Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g E 20171231 13537-447_ac3d4876-f64f-4f61-8586-ba18729f7666 13537-447 HUMAN OTC DRUG LBEL LEDERM 45plus Jour SPF 15 Facial Treatment Against Noticeable Signs of Aging Day - Normal to Dry Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g N 20181231 13537-448_4b1995b6-09c5-4828-8f20-3d972ca007d0 13537-448 HUMAN OTC DRUG LBEL LEDERM 55plus Jour SPF 15 Facial Treatment Against Advanced Signs of Aging Day - All Skin Types Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g E 20171231 13537-449_c0d42f77-a9ac-4d0b-967a-91b8d868ed4e 13537-449 HUMAN OTC DRUG CYZONE CY SOLUXION Aclaradora FPS 15 Octinoxate and Oxybenzone CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .075; .045 g/g; g/g E 20171231 13537-450_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-450 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 COFFEE SWEET Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g E 20171231 13537-451_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-451 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 ROSA BELLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g E 20171231 13537-452_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-452 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 DURAZNO GLAM Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g E 20171231 13537-453_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-453 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 ROSA CANDY Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g E 20171231 13537-454_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-454 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 CORAL SEDUCTION Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g E 20171231 13537-455_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-455 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 CHERRY CLASS Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g E 20171231 13537-456_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-456 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 RED SUPREME Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g E 20171231 13537-457_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-457 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 VINO MIDNIGHT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g E 20171231 13537-458_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-458 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 FUCSIA FEMME Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g E 20171231 13537-459_02c32b39-d0e3-42ad-bb09-25fc69a91741 13537-459 HUMAN OTC DRUG ESIKA Perfect Match SPF 20 CEREZA DEEP Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .07; .025 g/g; g/g E 20171231 13537-460_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-460 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (FUXIA DEFENSE) - MAGENTA Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-461_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-461 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (GRAPE CARE) - RED Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-462_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-462 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (FLASHY KARMIN) - RED Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-463_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-463 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (PINK STAR) - PINK Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-464_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-464 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (LILAC ZIMMER) - LILAC Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-465_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-465 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (SHINY BROWN) - BROWN Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-466_56761eca-a1fc-417e-8fd1-4929b9d81cf7 13537-466 HUMAN OTC DRUG CY BETTER LIPS BALM Humectante para Labios con color FPS 18 (SUN LIGHT) - BEIGE Avobenzone, Octisalate, Zinc Oxide, Octinoxate, and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; ZINC OXIDE; OCTINOXATE; OXYBENZONE .0003; .0003; .01; .071; .02 g/g; g/g; g/g; g/g; g/g E 20171231 13537-467_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-467 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (PECHE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-468_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-468 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (GRAPE LUMIERE) - MAGENTA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-469_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-469 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (SWEET FRAMBOISE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-470_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-470 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (DOUCE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-471_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-471 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (VIN) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-472_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-472 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (CARAMEL MELON) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-473_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-473 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (GROSEILLE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-474_2156c7d0-09a6-4f68-84b7-a2442b799fd9 13537-474 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (VIN SENSUELLE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-475_e7011f70-9378-473f-9f18-a36f25a44297 13537-475 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (PIMIENTA CALIENTE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-476_e7011f70-9378-473f-9f18-a36f25a44297 13537-476 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (MARRON GLAMOUR) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-477_e7011f70-9378-473f-9f18-a36f25a44297 13537-477 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (BORGONA SEXY) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-478_e7011f70-9378-473f-9f18-a36f25a44297 13537-478 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROSA DULZURA) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-479_e7011f70-9378-473f-9f18-a36f25a44297 13537-479 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROJO DESEO) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-480_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-480 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (VINO CALIENTE) - PURPLE Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-481_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-481 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (PIMIENTA CALIENTE) - BROWN Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-482_792c819f-2274-4a4f-b536-760af982daa4 13537-482 HUMAN OTC DRUG CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (LIGHT 1) - BEIGE Octinoxate POWDER TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .05 g/g N 20181231 13537-483_792c819f-2274-4a4f-b536-760af982daa4 13537-483 HUMAN OTC DRUG CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (LIGHT 2) - BEIGE Octinoxate POWDER TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .05 g/g N 20181231 13537-484_792c819f-2274-4a4f-b536-760af982daa4 13537-484 HUMAN OTC DRUG CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (MEDIUM 1) - BEIGE Octinoxate POWDER TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .05 g/g N 20181231 13537-485_792c819f-2274-4a4f-b536-760af982daa4 13537-485 HUMAN OTC DRUG CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (MEDIUM 2) - BEIGE Octinoxate POWDER TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .05 g/g N 20181231 13537-486_792c819f-2274-4a4f-b536-760af982daa4 13537-486 HUMAN OTC DRUG CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (MEDIUM 3) - BEIGE Octinoxate POWDER TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .05 g/g N 20181231 13537-487_792c819f-2274-4a4f-b536-760af982daa4 13537-487 HUMAN OTC DRUG CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (MEDIUM 4) - BROWN Octinoxate POWDER TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .05 g/g N 20181231 13537-488_792c819f-2274-4a4f-b536-760af982daa4 13537-488 HUMAN OTC DRUG CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (OBSCURE 1) - BROWN Octinoxate POWDER TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .05 g/g N 20181231 13537-489_811a531d-d633-4068-85ba-92dda4633870 13537-489 HUMAN OTC DRUG CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (LIGHT 1) - BEIGE Octinoxate and Zinc Oxide CREAM TOPICAL 20150826 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .04; .024 g/g; g/g N 20181231 13537-490_e591ae1e-efb0-4f7c-9e19-f2651652caf7 13537-490 HUMAN OTC DRUG esika MAX ANTIPERSPIRANT ROLL-ON DEODORANT Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130527 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-491_d43080da-f846-4bd5-aab7-837c75ea3f4a 13537-491 HUMAN OTC DRUG CYZONE FLIRTY GIRL DESODORANTE ANTITRANSPIRANTE ROLL-ON no contiene alcohol Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130527 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-492_9916ab3c-1ab5-4794-a5f3-4ecb5649899b 13537-492 HUMAN OTC DRUG CYZONE ATTRAK DESODORANTE ANTITRANSPIRANTE ROLL-ON no contiene alcohol Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130527 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-493_d559a821-7a1b-4251-9f9f-c69daf4542d4 13537-493 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Claire 1-2-3 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g E 20171231 13537-494_d559a821-7a1b-4251-9f9f-c69daf4542d4 13537-494 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Claire 4 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g E 20171231 13537-495_d559a821-7a1b-4251-9f9f-c69daf4542d4 13537-495 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Medium 5 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g E 20171231 13537-496_d559a821-7a1b-4251-9f9f-c69daf4542d4 13537-496 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Medium 6 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g E 20171231 13537-497_d559a821-7a1b-4251-9f9f-c69daf4542d4 13537-497 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Medium 7 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g E 20171231 13537-498_d559a821-7a1b-4251-9f9f-c69daf4542d4 13537-498 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Obscure 8-9 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g E 20171231 13537-499_f47034d3-848d-41e3-96c5-e843b3f37367 13537-499 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Claire 1-2-3 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g N 20181231 13537-500_f47034d3-848d-41e3-96c5-e843b3f37367 13537-500 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Claire 4 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g N 20181231 13537-501_f47034d3-848d-41e3-96c5-e843b3f37367 13537-501 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Medium 5 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g N 20181231 13537-502_f47034d3-848d-41e3-96c5-e843b3f37367 13537-502 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Medium 6 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g N 20181231 13537-503_f47034d3-848d-41e3-96c5-e843b3f37367 13537-503 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Medium 7 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g N 20181231 13537-504_f47034d3-848d-41e3-96c5-e843b3f37367 13537-504 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Obscure 8-9 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g N 20181231 13537-505_25e9c97b-57e7-4f2f-b59c-014a106c0712 13537-505 HUMAN OTC DRUG esika total sec DELICATE SKIN Alcohol Free Womens Deodorant and Antiperspirant - All day protection Aluminum Chlorohydrate SPRAY TOPICAL 20130527 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM CHLOROHYDRATE .045 g/mL E 20171231 13537-506_38a0e8f3-e2dc-428e-934d-4e4b0ef303dd 13537-506 HUMAN OTC DRUG esika total sec NEUTRAL FRAGRANCE Alcohol Free Unisex Deodorant and Antiperspirant - All day protection Aluminum Chlorohydrate SPRAY TOPICAL 20130527 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM CHLOROHYDRATE .045 g/mL E 20171231 13537-507_647ffc78-080d-45ce-99e6-ce101e402a2d 13537-507 HUMAN OTC DRUG LBEL ESSENTIAL Deep moisturizing and oxygenating SPF 20 normal to dry skin Avobenzone, Octinoxate, Octisalate, and Octocrylene CREAM TOPICAL 20161025 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .03; .05; .06 g/g; g/g; g/g; g/g E 20171231 13537-508_bf6c4b3a-437f-403b-9e51-9ae741c42e6b 13537-508 HUMAN OTC DRUG LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE PARADISE - PINK Octinoxate and Zinc Oxide LIPSTICK TOPICAL 20161026 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .075; .049 g/g; g/g E 20171231 13537-509_bf6c4b3a-437f-403b-9e51-9ae741c42e6b 13537-509 HUMAN OTC DRUG LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 ROSE COTTON - PINK Octinoxate and Zinc Oxide LIPSTICK TOPICAL 20161026 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .075; .049 g/g; g/g E 20171231 13537-510_bf6c4b3a-437f-403b-9e51-9ae741c42e6b 13537-510 HUMAN OTC DRUG LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CERISE BRISE - PINK Octinoxate and Zinc Oxide LIPSTICK TOPICAL 20161026 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .075; .049 g/g; g/g E 20171231 13537-511_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-511 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MOKA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-512_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-512 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROMANCE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-513_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-513 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROSE NATURAL Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-514_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-514 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROSE CLASIQUE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-515_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-515 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROUGE INTENSE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-516_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-516 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - AMOUR Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-517_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-517 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - CHOCOLAT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-518_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-518 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ALMOND Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-519_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-519 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MALVE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-520_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-520 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MARRON GLACE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-521_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-521 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - TULIP Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-522_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-522 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - NUDE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-523_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-523 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - LILY BEIGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-524_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-524 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MANDARINE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-525_7b8554e1-c69d-48ee-9b18-ec7c0418bc1d 13537-525 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - VIN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-526_a79a2640-f02d-4733-afab-cbe61b2043cc 13537-526 HUMAN OTC DRUG esika JADISS Glam Antiperspirant Roll-on Deodorant Aluminum Sesquichlorohydrate LIQUID TOPICAL 20130527 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD. ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-527_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-527 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE CHAMPAGNE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-528_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-528 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - FUCSIA SPLENDIDE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-529_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-529 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE DAMOUR Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-530_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-530 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE FORMIDABLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-531_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-531 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - NATURAL PERSISTANT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-532_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-532 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MIEL ECHANTER Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-533_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-533 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE PRODIGEUX Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-534_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-534 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MARRON ILLIMITE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-535_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-535 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CHOCOLAT MAJESTIC Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-536_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-536 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CAFE SUCCES Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-537_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-537 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE GRANDOISE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-538_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-538 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE RUBI Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-539_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-539 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - SAUMON ESSENTIEL Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-540_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-540 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - BOURGOGNE VIF Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-541_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-541 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - VIOLET POURPRE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-542_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-542 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CORAIL MAXIMUM Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-543_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-543 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ORANGE DELIRANT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-544_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-544 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE INTENSE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-545_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-545 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE FEMME Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-546_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-546 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - DORE CHOCOLAT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-547_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-547 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MER DE ROSES Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-548_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-548 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE TENTATION Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-549_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-549 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE DELICAT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-550_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-550 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - FUCSIA DESIR Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-551_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-551 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE PROVOCATION Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-552_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-552 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - AMPLIFFIER AMANDIER Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-553_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-553 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - SOBRIETE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-554_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-554 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - FIANCEE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-555_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-555 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROMANCE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-556_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-556 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CARMINE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-557_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-557 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - NOBLESSE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-558_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-558 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MALBEC Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-559_bda95f66-6663-44ca-9320-bc31d6e01a7d 13537-559 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE FUCSIA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 13537-560_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-560 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - CLAIRE 1 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL E 20171231 13537-561_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-561 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - CLAIRE 2 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL E 20171231 13537-562_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-562 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - CLAIRE 3 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL E 20171231 13537-563_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-563 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - CLAIRE 4 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL E 20171231 13537-564_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-564 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - MEDIUM 5 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL E 20171231 13537-565_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-565 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - MEDIUM 6 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL E 20171231 13537-566_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-566 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - MEDIUM 7 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL E 20171231 13537-567_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-567 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - OBSCURE 8 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL E 20171231 13537-568_430fc14d-555e-4bbe-8ba7-c5a43361b62b 13537-568 HUMAN OTC DRUG LBEL EFFET PARFAIT filling effect foundation SPF 10 - OBSCURE 9 Octinoxate LIQUID TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD. OCTINOXATE .07 g/mL E 20171231 13537-569_bf6c4b3a-437f-403b-9e51-9ae741c42e6b 13537-569 HUMAN OTC DRUG LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE CARAMEL - BEIGE Octinoxate and Zinc Oxide LIPSTICK TOPICAL 20161026 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .075; .049 g/g; g/g E 20171231 13537-570_a2aaa07b-d6c5-4f4a-9b5d-0d9c40ae91a5 13537-570 HUMAN OTC DRUG LBEL EFFET PARFAIT DUAL-USE COMPACT YOUTHFUL LOOKING SKIN SPF7 Titanium Dioxide POWDER TOPICAL 20130916 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD. TITANIUM DIOXIDE .05 g/g E 20171231 13537-571_811a531d-d633-4068-85ba-92dda4633870 13537-571 HUMAN OTC DRUG CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (LIGHT 2) - BEIGE Octinoxate and Zinc Oxide CREAM TOPICAL 20150826 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .04; .024 g/g; g/g N 20181231 13537-572_811a531d-d633-4068-85ba-92dda4633870 13537-572 HUMAN OTC DRUG CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (MEDIUM 1) - BEIGE Octinoxate and Zinc Oxide CREAM TOPICAL 20150826 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .04; .024 g/g; g/g N 20181231 13537-573_811a531d-d633-4068-85ba-92dda4633870 13537-573 HUMAN OTC DRUG CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (MEDIUM 2) - BEIGE Octinoxate and Zinc Oxide CREAM TOPICAL 20150826 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .04; .024 g/g; g/g N 20181231 13537-574_811a531d-d633-4068-85ba-92dda4633870 13537-574 HUMAN OTC DRUG CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (MEDIUM 3) - BEIGE Octinoxate and Zinc Oxide CREAM TOPICAL 20150826 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .04; .024 g/g; g/g N 20181231 13537-575_811a531d-d633-4068-85ba-92dda4633870 13537-575 HUMAN OTC DRUG CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (MEDIUM 4) - BROWN Octinoxate and Zinc Oxide CREAM TOPICAL 20150826 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .04; .024 g/g; g/g N 20181231 13537-576_811a531d-d633-4068-85ba-92dda4633870 13537-576 HUMAN OTC DRUG CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 (OBSCURE 1) - BROWN Octinoxate and Zinc Oxide CREAM TOPICAL 20150826 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .04; .024 g/g; g/g N 20181231 13537-577_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-577 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD PIMIENTA CALIENTE) - BROWN OCTINOXATE LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-578_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-578 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD VINO CAUTIVANTE) - BROWN OCTINOXATE LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-579_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-579 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSA VIVA) - PINK OCTINOXATE LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-580_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-580 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CORAL ENSUENO) - RED OCTINOXATE LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-581_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-581 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROJO GLAM) - RED OCTINOXATE LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-582_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-582 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CAFE HABANO) - BROWN OCTINOXATE LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-583_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-583 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FUCSIA VIBRANTE) - PINK OCTINOXATE LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-584_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-584 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MELON INTENSE) - PINK OCTINOXATE LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-585_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-585 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSADO CHIC) - PINK OCTINOXATE LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-586_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-586 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CIRUELA GLAM) - RED OCTINOXATE LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-587_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-587 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FRAMBUESA ENCANTO) - PURPLE OCTINOXATE LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-588_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-588 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MAGENTA SWEET) - PURPLE OCTINOXATE LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-589_43e6be26-2591-47f9-92d5-3dccf3a32ed8 13537-589 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 Octinoxate KIT 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD E 20171231 13537-590_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-590 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON GLAMOUR) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-591_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-591 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO DESEO) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-592_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-592 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO INTRIGANTE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-593_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-593 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO LUJURIA) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-594_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-594 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CORAL CHIC) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-595_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-595 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ENCANTO) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-596_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-596 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (BORGONA SEXY) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-597_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-597 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-598_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-598 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (GRANATE SEDUCTOR) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-599_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-599 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ROMANTICA) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-600_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-600 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 1) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-601_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-601 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 2) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-602_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-602 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 3) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-603_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-603 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 4) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-604_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-604 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 5) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-605_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-605 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 6) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-606_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-606 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 7) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-607_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-607 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (OBSCURE 8) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-608_732972ef-6af2-4fce-ac59-d5cfcc51d9a5 13537-608 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (OBSCURE 9) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-609_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-609 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (NARANJA PRIMAVERA) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-610_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-610 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FRAMBUESA MANIA) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-611_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-611 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA DULZURA) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-612_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-612 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (PIMIENTA CALIENTE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-613_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-613 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CANELA NUDE) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-614_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-614 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MORA GLAM) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-615_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-615 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CORAL INTENSE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-616_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-616 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FRESA COQUETA) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-617_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-617 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (PIMIENTA CALIENTE FEMME) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-618_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-618 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (GRANATE SEDUCTOR FEMME) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-619_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-619 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE FEMME) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-620_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-620 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ROMANTICA FEMME) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-621_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-621 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO INTRIGANTE FEMME) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-622_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-622 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ENCANTO FEMME) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-623_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-623 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA GEOMETRIC) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-624_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-624 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA PRISMA) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-625_cc5a653f-ffc4-41f4-87b2-4622bb3c2086 13537-625 HUMAN OTC DRUG ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 1) - BROWN Octinoxate and Oxybenzone EMULSION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 13537-626_cc5a653f-ffc4-41f4-87b2-4622bb3c2086 13537-626 HUMAN OTC DRUG ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 2) - BROWN Octinoxate and Oxybenzone EMULSION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 13537-627_cc5a653f-ffc4-41f4-87b2-4622bb3c2086 13537-627 HUMAN OTC DRUG ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 3) - BROWN Octinoxate and Oxybenzone EMULSION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 13537-628_cc5a653f-ffc4-41f4-87b2-4622bb3c2086 13537-628 HUMAN OTC DRUG ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 4) - BROWN Octinoxate and Oxybenzone EMULSION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 13537-629_cc5a653f-ffc4-41f4-87b2-4622bb3c2086 13537-629 HUMAN OTC DRUG ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 5) - BROWN Octinoxate and Oxybenzone EMULSION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 13537-630_cc5a653f-ffc4-41f4-87b2-4622bb3c2086 13537-630 HUMAN OTC DRUG ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 6) - BROWN Octinoxate and Oxybenzone EMULSION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 13537-631_cc5a653f-ffc4-41f4-87b2-4622bb3c2086 13537-631 HUMAN OTC DRUG ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 1) - PINK Octinoxate and Oxybenzone EMULSION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 13537-632_cc5a653f-ffc4-41f4-87b2-4622bb3c2086 13537-632 HUMAN OTC DRUG ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 2) - PINK Octinoxate and Oxybenzone EMULSION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 13537-633_cc5a653f-ffc4-41f4-87b2-4622bb3c2086 13537-633 HUMAN OTC DRUG ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 3) - PINK Octinoxate and Oxybenzone EMULSION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 13537-634_cc5a653f-ffc4-41f4-87b2-4622bb3c2086 13537-634 HUMAN OTC DRUG ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 4) - PINK Octinoxate and Oxybenzone EMULSION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 13537-635_cc5a653f-ffc4-41f4-87b2-4622bb3c2086 13537-635 HUMAN OTC DRUG ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 5) - PINK Octinoxate and Oxybenzone EMULSION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 13537-636_cc5a653f-ffc4-41f4-87b2-4622bb3c2086 13537-636 HUMAN OTC DRUG ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 6) - PINK Octinoxate and Oxybenzone EMULSION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 13537-637_6f7530ab-de1f-4e84-a4bb-4fc1bfc61eec 13537-637 HUMAN OTC DRUG LBEL ESSENTIAL deep moisturizing and oxygenating SPF 20 normal to oily skin Avobenzone, Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20150309 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .03; .05; .06 g/mL; g/mL; g/mL; g/mL E 20171231 13537-638_a18be7ad-727e-4429-a843-9924fd65f743 13537-638 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (MARRON HAVANA) - BROWN Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-639_a18be7ad-727e-4429-a843-9924fd65f743 13537-639 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (NATURAL DUNE) - PINK Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-640_a18be7ad-727e-4429-a843-9924fd65f743 13537-640 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (MARRON FANATIC) - RED Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-641_ee91a4e0-e3ee-453a-bfef-85e2f930908e 13537-641 HUMAN OTC DRUG LBEL ESSENTIAL moisturizing and oxygenating SPF 20 normal to dry skin Avobenzone, Octinoxate, Octisalate, and Octocrylene CREAM TOPICAL 20150309 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .03; .05; .06 g/g; g/g; g/g; g/g E 20171231 13537-642_a18be7ad-727e-4429-a843-9924fd65f743 13537-642 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (ROJO FIESTA) - RED Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-643_a18be7ad-727e-4429-a843-9924fd65f743 13537-643 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (MARRON BAMBU) - BROWN Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-644_a18be7ad-727e-4429-a843-9924fd65f743 13537-644 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (FUCSIA DELIRIO) - PINK Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-645_a18be7ad-727e-4429-a843-9924fd65f743 13537-645 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (ROJO PASION) - RED Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-646_a18be7ad-727e-4429-a843-9924fd65f743 13537-646 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (FUCSIA SUBLIME) - PINK Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-647_a18be7ad-727e-4429-a843-9924fd65f743 13537-647 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (ROSA FIORELLE) - PINK Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-648_a18be7ad-727e-4429-a843-9924fd65f743 13537-648 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (NARANJA OBSESION) - ORANGE Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-649_a18be7ad-727e-4429-a843-9924fd65f743 13537-649 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (BORGONA SWEET) - PINK Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-650_a18be7ad-727e-4429-a843-9924fd65f743 13537-650 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (VINO DESEO) - PURPLE Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-651_a18be7ad-727e-4429-a843-9924fd65f743 13537-651 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 (FUCSIA TENTACION) - PINK Octinoxate LIPSTICK TOPICAL 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-652_07202687-0501-4266-b2b2-401d30b7bfc2 13537-652 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS Dual with triple gloss effect SPF 15 (FUCSIA) - PURPLE Octinoxate LIPSTICK TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-653_07202687-0501-4266-b2b2-401d30b7bfc2 13537-653 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS Dual with triple gloss effect SPF 15 (CEREZA) - RED Octinoxate LIPSTICK TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-654_07202687-0501-4266-b2b2-401d30b7bfc2 13537-654 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS Dual with triple gloss effect SPF 15 (ROSA) - RED Octinoxate LIPSTICK TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-655_07202687-0501-4266-b2b2-401d30b7bfc2 13537-655 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS Dual with triple gloss effect SPF 15 (RUBI) - RED Octinoxate LIPSTICK TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-656_07202687-0501-4266-b2b2-401d30b7bfc2 13537-656 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS Dual with triple gloss effect SPF 15 (AMBAR) - BROWN Octinoxate LIPSTICK TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-657_07202687-0501-4266-b2b2-401d30b7bfc2 13537-657 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS Dual with triple gloss effect SPF 15 (FRESA) - RED Octinoxate LIPSTICK TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-658_07202687-0501-4266-b2b2-401d30b7bfc2 13537-658 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS Dual with triple gloss effect SPF 15 (CHAMPAGE) - BEIGE Octinoxate LIPSTICK TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-659_07202687-0501-4266-b2b2-401d30b7bfc2 13537-659 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS Dual with triple gloss effect SPF 15 (COBRE) - ORANGE Octinoxate LIPSTICK TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-660_07202687-0501-4266-b2b2-401d30b7bfc2 13537-660 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS Dual with triple gloss effect SPF 15 (PIMIENTA CALIENTE) - BROWN Octinoxate LIPSTICK TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-661_07202687-0501-4266-b2b2-401d30b7bfc2 13537-661 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS Dual with triple gloss effect SPF 15 (DIAMANTE ROSA) - PINK Octinoxate LIPSTICK TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-662_07202687-0501-4266-b2b2-401d30b7bfc2 13537-662 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS Dual with triple gloss effect SPF 15 (MELON) - PINK Octinoxate LIPSTICK TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-663_07202687-0501-4266-b2b2-401d30b7bfc2 13537-663 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS Dual with triple gloss effect SPF 15 (VINO) - BROWN Octinoxate LIPSTICK TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .07 g/g E 20171231 13537-664_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-664 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (NARANJA ESFERA) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-665_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-665 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (NUDE INFINITO) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-666_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-666 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO ESIKA) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-667_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-667 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON TOPACIO) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-668_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-668 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA AMATISTA) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-669_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-669 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 Octinoxate and Oxybenzone KIT 20150825 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD E 20171231 13537-670_9033566c-3fa7-498b-87e7-7df376215fc3 13537-670 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 CLAIRE 1- BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-671_9033566c-3fa7-498b-87e7-7df376215fc3 13537-671 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 CLAIRE 2- BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-672_9033566c-3fa7-498b-87e7-7df376215fc3 13537-672 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 CLAIRE 3- BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-673_9033566c-3fa7-498b-87e7-7df376215fc3 13537-673 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 CLAIRE 4- BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-674_9033566c-3fa7-498b-87e7-7df376215fc3 13537-674 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 MEDIUM 5- BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-675_9033566c-3fa7-498b-87e7-7df376215fc3 13537-675 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 MEDIUM 6- BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-676_9033566c-3fa7-498b-87e7-7df376215fc3 13537-676 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 MEDIUM 7- BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-677_9033566c-3fa7-498b-87e7-7df376215fc3 13537-677 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 OBSCURE 8- BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-678_9033566c-3fa7-498b-87e7-7df376215fc3 13537-678 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 OBSCURE 9- BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 13537-681_7589969e-b476-421f-9d1c-77aaa50fd8dc 13537-681 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM CLAIRE 1 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 13537-682_7589969e-b476-421f-9d1c-77aaa50fd8dc 13537-682 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM CLAIRE 2 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 13537-683_7589969e-b476-421f-9d1c-77aaa50fd8dc 13537-683 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM CLAIRE 3 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 13537-684_7589969e-b476-421f-9d1c-77aaa50fd8dc 13537-684 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM CLAIRE 4 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 13537-685_7589969e-b476-421f-9d1c-77aaa50fd8dc 13537-685 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM MEDIUM 5 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 13537-686_7589969e-b476-421f-9d1c-77aaa50fd8dc 13537-686 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM MEDIUM 6 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 13537-687_7589969e-b476-421f-9d1c-77aaa50fd8dc 13537-687 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM MEDIUM 7 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 13537-688_a18be7ad-727e-4429-a843-9924fd65f743 13537-688 HUMAN OTC DRUG ESIKA PRO ADVANCE LASTING Long-lasting and comfort SPF 20 Octinoxate KIT 20150417 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD E 20171231 13537-689_7589969e-b476-421f-9d1c-77aaa50fd8dc 13537-689 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM OBSCURE 8 - BROWN Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 13537-690_7589969e-b476-421f-9d1c-77aaa50fd8dc 13537-690 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM OBSCURE 9 - BROWN Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 13537-691_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-691 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CORAL QUARZO) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-692_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-692 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (NUDE PRISMA) - BEIGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-693_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-693 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (DORADO ESENCIAL) - YELLOW OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-694_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-694 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (PIMIENTA CALIENTE EXOTIC) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-695_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-695 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ENCANTO EXOTIC) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-696_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-696 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CORAL CHIC EXOTIC) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-697_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-697 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-698_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-698 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO DESEO EXOTIC) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-699_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-699 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FRAMBUESA MANIA EXOTIC) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-700_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-700 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (BORGONA SEXY EXOTIC) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-701_abc04a70-8b3c-4c57-aaad-41e040947c7f 13537-701 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON GLAMOR EXOTIC) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-702_1de085f7-dee6-4a0c-991f-4f4511cdbd4e 13537-702 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (MEDIUM 6) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150817 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 13537-703_9caf097d-773a-4f9b-b5cc-b38f5881f6f7 13537-703 HUMAN OTC DRUG LBEL EFFET PARFAIT Lip moisturizer SPF 18 FM Hidratante para labios FPS 18 FM Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK TOPICAL 20151208 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .03; .008 g/g; g/g; g/g E 20171231 13537-704_ec6e8395-a148-4675-9c45-fc7ec42e0cfe 13537-704 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM PECHE - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-705_ec6e8395-a148-4675-9c45-fc7ec42e0cfe 13537-705 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM SWEET FRAMBOISE - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-706_ec6e8395-a148-4675-9c45-fc7ec42e0cfe 13537-706 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM DOUCE - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-707_ec6e8395-a148-4675-9c45-fc7ec42e0cfe 13537-707 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM VIN - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-708_ec6e8395-a148-4675-9c45-fc7ec42e0cfe 13537-708 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM GRAPE LUMIERE - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-709_ec6e8395-a148-4675-9c45-fc7ec42e0cfe 13537-709 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM CARAMEL MELON - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-710_ec6e8395-a148-4675-9c45-fc7ec42e0cfe 13537-710 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM GROSEILLE - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-711_ec6e8395-a148-4675-9c45-fc7ec42e0cfe 13537-711 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM VIN SENSUELLE - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 13537-712_7d329a3b-e8e8-47eb-bfdb-56f179407526 13537-712 HUMAN OTC DRUG Esika PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA GALA MATE - PURPLE Octinoxate LIPSTICK TOPICAL 20151214 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-713_7d329a3b-e8e8-47eb-bfdb-56f179407526 13537-713 HUMAN OTC DRUG Esika PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FRAMBUESA GLAM MATE - RED Octinoxate LIPSTICK TOPICAL 20151214 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-714_7d329a3b-e8e8-47eb-bfdb-56f179407526 13537-714 HUMAN OTC DRUG Esika PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROSA DESEO MATE - PINK Octinoxate LIPSTICK TOPICAL 20151214 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-715_7d329a3b-e8e8-47eb-bfdb-56f179407526 13537-715 HUMAN OTC DRUG Esika PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA PINK MATE - PURPLE Octinoxate LIPSTICK TOPICAL 20151214 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-716_7d329a3b-e8e8-47eb-bfdb-56f179407526 13537-716 HUMAN OTC DRUG Esika PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROJO PASION MATE - RED Octinoxate LIPSTICK TOPICAL 20151214 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-717_7d329a3b-e8e8-47eb-bfdb-56f179407526 13537-717 HUMAN OTC DRUG Esika PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 PIMIENTA CALIENTE MATE - BROWN Octinoxate LIPSTICK TOPICAL 20151214 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-718_7d329a3b-e8e8-47eb-bfdb-56f179407526 13537-718 HUMAN OTC DRUG Esika PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FRESA PROFUNDO MATE - RED Octinoxate LIPSTICK TOPICAL 20151214 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-719_7d329a3b-e8e8-47eb-bfdb-56f179407526 13537-719 HUMAN OTC DRUG Esika PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA VIBRANTE MATE - PURPLE Octinoxate LIPSTICK TOPICAL 20151214 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-720_7d329a3b-e8e8-47eb-bfdb-56f179407526 13537-720 HUMAN OTC DRUG Esika PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROSA VIVA MATE - PINK Octinoxate LIPSTICK TOPICAL 20151214 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g E 20171231 13537-721_b1d64ef1-0bfb-4617-abce-da12d354a9f7 13537-721 HUMAN OTC DRUG LBEL EFFET PARFAIT Loose extra-fine portable SPF 15 FM PORCELAINE- BEIGE OCTINOXATE, TITANIUM DIOXIDE, and OXYBENZONE POWDER TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE .03; .0354; .03 g/g; g/g; g/g N 20181231 13537-722_b1d64ef1-0bfb-4617-abce-da12d354a9f7 13537-722 HUMAN OTC DRUG LBEL EFFET PARFAIT Loose extra-fine portable SPF 15 FM TRANSLUCIDE- BEIGE OCTINOXATE, TITANIUM DIOXIDE, and OXYBENZONE POWDER TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE .03; .0354; .03 g/g; g/g; g/g N 20181231 13537-723_b1d64ef1-0bfb-4617-abce-da12d354a9f7 13537-723 HUMAN OTC DRUG LBEL EFFET PARFAIT Loose extra-fine portable SPF 15 FM SANTE- BEIGE OCTINOXATE, TITANIUM DIOXIDE, and OXYBENZONE POWDER TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE .03; .0354; .03 g/g; g/g; g/g N 20181231 13537-724_cb44fc4d-dd66-45e1-afdc-e07acbee2f8b 13537-724 HUMAN OTC DRUG ESIKA PASSION MUSK ANTIPERSPIRANT ROLL-ON DEODORANT FM ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20151222 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-725_6e02dd52-a142-446c-adb6-382de421054f 13537-725 HUMAN OTC DRUG ESIKA BRAVIO CHRISTIAN MEIER ANTIPERSPIRANT ROLL-ON DEODORANT FM ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20151222 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-726_c49300ef-efb5-418d-9948-8716b3c252f3 13537-726 HUMAN OTC DRUG ESIKA WINNER BLACK ANTIPERSPIRANT ROLL-ON DEODORANT FM ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20151223 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-727_df8825ce-3c9e-45f0-acd6-d05ec4745dd4 13537-727 HUMAN OTC DRUG ESIKA DARIEN CLASS ANTIPERSPIRANT ROLL-ON DEODORANT FM ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20151222 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-728_593e07b7-5c15-4c69-8c76-330f7b86fd1d 13537-728 HUMAN OTC DRUG ESIKA PULSO CHRISTIAN MEIER ANTIPERSPIRANT ROLL-ON DEODORANT FM ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20151222 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-729_21aef774-dc85-46cd-a102-7678b5a918db 13537-729 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD PIMIENTA CALIENTE) - BROWN OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-730_21aef774-dc85-46cd-a102-7678b5a918db 13537-730 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD VINO CAUTIVANTE) - BROWN OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-731_21aef774-dc85-46cd-a102-7678b5a918db 13537-731 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSA VIVA) - PINK OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-732_21aef774-dc85-46cd-a102-7678b5a918db 13537-732 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CORAL ENSUENO) - RED OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-733_21aef774-dc85-46cd-a102-7678b5a918db 13537-733 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROJO GLAM) - RED OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-734_21aef774-dc85-46cd-a102-7678b5a918db 13537-734 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CAFE HABANO) - BROWN OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-735_21aef774-dc85-46cd-a102-7678b5a918db 13537-735 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FUCSIA VIBRANTE) - PINK OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-736_21aef774-dc85-46cd-a102-7678b5a918db 13537-736 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MELON INTENSE) - PINK OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-737_21aef774-dc85-46cd-a102-7678b5a918db 13537-737 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSADO CHIC) - PINK OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-738_21aef774-dc85-46cd-a102-7678b5a918db 13537-738 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CIRUELA GLAM) - RED OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-739_21aef774-dc85-46cd-a102-7678b5a918db 13537-739 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FRAMBUESA ENCANTO) - PURPLE OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-740_21aef774-dc85-46cd-a102-7678b5a918db 13537-740 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MAGENTA SWEET) - PURPLE OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-741_21aef774-dc85-46cd-a102-7678b5a918db 13537-741 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD LAVA LIPS) - ORANGE OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-742_21aef774-dc85-46cd-a102-7678b5a918db 13537-742 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FRESA IMPERIAL) - RED OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-743_21aef774-dc85-46cd-a102-7678b5a918db 13537-743 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FUCSIA OPULENTO) - PINK OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-744_21aef774-dc85-46cd-a102-7678b5a918db 13537-744 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD BERRY BALCANIC) - RED OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-745_21aef774-dc85-46cd-a102-7678b5a918db 13537-745 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSA OBSESSION) - PINK OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-746_21aef774-dc85-46cd-a102-7678b5a918db 13537-746 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROJO EXHUBERANTE) - RED OCTINOXATE LIPSTICK TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 13537-747_21aef774-dc85-46cd-a102-7678b5a918db 13537-747 HUMAN OTC DRUG ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 Octinoxate KIT 20160229 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD N 20181231 13537-748_1de085f7-dee6-4a0c-991f-4f4511cdbd4e 13537-748 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (MEDIUM 7) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150817 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 13537-749_1de085f7-dee6-4a0c-991f-4f4511cdbd4e 13537-749 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (OBSCURE 8) - BROWN Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150817 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 13537-750_1de085f7-dee6-4a0c-991f-4f4511cdbd4e 13537-750 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (OBSCURE 9) - BROWN Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150817 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 13537-751_0500d778-7a1b-472b-8171-a6230814c9d6 13537-751 HUMAN OTC DRUG ESIKA MEN 2 EN 1 ANTIDANDRUFF MULTI-ACTION Pyrithione Zinc LIQUID TOPICAL 20150817 OTC MONOGRAPH FINAL part358H Ventura Corporation LTD PYRITHIONE ZINC .05 g/mL E 20171231 13537-752_975bb122-95dd-40bf-b156-07d366105904 13537-752 HUMAN OTC DRUG ESIKA ITS YOU ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160818 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-754_b370c0f4-775e-4b52-9120-18c2a18f7217 13537-754 HUMAN OTC DRUG LBEL LEDERM 55 plus JOUR Facial against advanced signs of aging Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20161024 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/mL; g/mL; g/mL; g/mL N 20181231 13537-755_bf6c4b3a-437f-403b-9e51-9ae741c42e6b 13537-755 HUMAN OTC DRUG LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE TRANSLUCIDE - BEIGE Octinoxate and Zinc Oxide LIPSTICK TOPICAL 20161026 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .075; .049 g/g; g/g E 20171231 13537-756_bf6c4b3a-437f-403b-9e51-9ae741c42e6b 13537-756 HUMAN OTC DRUG LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 CORAL PETALE - PINK Octinoxate and Zinc Oxide LIPSTICK TOPICAL 20161026 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .075; .049 g/g; g/g E 20171231 13537-757_c0cbb88a-9ca3-48f0-b29c-55b1f339701a 13537-757 HUMAN OTC DRUG ESIKA WINNER SPORT ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160818 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-758_51b9a8bd-df36-402d-aa94-caf254c1976d 13537-758 HUMAN OTC DRUG ESIKA VANILLA SCENT ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160818 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-759_0fd22f0d-c3a0-4523-8ddf-07de79cc5281 13537-759 HUMAN OTC DRUG ESIKA MOMENTOS LIBERTAD ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160819 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-760_cd6d1265-5dc6-4c13-8d05-dacbda64e9bf 13537-760 HUMAN OTC DRUG ESIKA STRONG MUSK ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160819 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-761_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-761 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (CAFE PARISO) - BROWN Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-762_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-762 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (ROSE BLOOM) - RED Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-763_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-763 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (FRESA ENERGY) - RED Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-764_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-764 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (BURGUNDY VITAL) - RED Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-765_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-765 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (VINO SUBLIME) - RED Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-766_14f09643-83d3-429d-a7c2-b6244fdc0345 13537-766 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN (ROJO RADIANT) - RED Octinoxate LIPSTICK TOPICAL 20150710 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 13537-800_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-800 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (BELLE NUDE) - BEIGE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-801_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-801 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (FUCSIA PASSION) - PURPLE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-802_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-802 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (VIN CHIC) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-804_e7011f70-9378-473f-9f18-a36f25a44297 13537-804 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROJO LUJURIA) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-805_e7011f70-9378-473f-9f18-a36f25a44297 13537-805 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (CORAL CHIC) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-806_e7011f70-9378-473f-9f18-a36f25a44297 13537-806 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROSA ENCANTO) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-807_e7011f70-9378-473f-9f18-a36f25a44297 13537-807 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (FUCSIA CAUTIVANTE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-808_e7011f70-9378-473f-9f18-a36f25a44297 13537-808 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (GRANATE SEDUCTOR) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-809_e7011f70-9378-473f-9f18-a36f25a44297 13537-809 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROSA ROMANTICA) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-810_e7011f70-9378-473f-9f18-a36f25a44297 13537-810 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (NARANJA PRIMAVERA) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-811_e7011f70-9378-473f-9f18-a36f25a44297 13537-811 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (FRAMBUESA MANIA) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-812_e7011f70-9378-473f-9f18-a36f25a44297 13537-812 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (FRESA COQUETA) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-813_e7011f70-9378-473f-9f18-a36f25a44297 13537-813 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (CANELA NUDE) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-814_e7011f70-9378-473f-9f18-a36f25a44297 13537-814 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (MORA GLAM) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-815_e7011f70-9378-473f-9f18-a36f25a44297 13537-815 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (CORAL INTENSE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-816_e7011f70-9378-473f-9f18-a36f25a44297 13537-816 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROSA GEOMETRIC) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-817_e7011f70-9378-473f-9f18-a36f25a44297 13537-817 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (FUCSIA PRISMA) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-818_e7011f70-9378-473f-9f18-a36f25a44297 13537-818 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (NARANJA ESFERA) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-819_e7011f70-9378-473f-9f18-a36f25a44297 13537-819 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (NUDE INFINITO) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-820_e7011f70-9378-473f-9f18-a36f25a44297 13537-820 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROJO ESIKA) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-821_e7011f70-9378-473f-9f18-a36f25a44297 13537-821 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (MARRON TOPACIO) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-822_e7011f70-9378-473f-9f18-a36f25a44297 13537-822 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (CORAL CUARZO) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-823_e7011f70-9378-473f-9f18-a36f25a44297 13537-823 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (FUCSIA AMATISTA) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-824_e7011f70-9378-473f-9f18-a36f25a44297 13537-824 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (NUDE PRISMA) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-825_e7011f70-9378-473f-9f18-a36f25a44297 13537-825 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (DORADO ESENCIAL) - YELLOW OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-826_e7011f70-9378-473f-9f18-a36f25a44297 13537-826 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROSA ENCANTO FEMME) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-827_e7011f70-9378-473f-9f18-a36f25a44297 13537-827 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (PIMIENTA CALIENTE FEMME) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-828_e7011f70-9378-473f-9f18-a36f25a44297 13537-828 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (GRANATE SEDUCTOR FEMME) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-829_e7011f70-9378-473f-9f18-a36f25a44297 13537-829 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROSA ROMANTICA FEMME) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-830_e7011f70-9378-473f-9f18-a36f25a44297 13537-830 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (FUCSIA CAUTIVANTE FEMME) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-831_e7011f70-9378-473f-9f18-a36f25a44297 13537-831 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROJO INTRIGANTE FEMME) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-832_e7011f70-9378-473f-9f18-a36f25a44297 13537-832 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (PIMIENTA CALIENTE EXOTIC) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-833_e7011f70-9378-473f-9f18-a36f25a44297 13537-833 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROSA ENCANTO EXOTIC) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-834_e7011f70-9378-473f-9f18-a36f25a44297 13537-834 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (CORAL CHIC EXOTIC) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-835_e7011f70-9378-473f-9f18-a36f25a44297 13537-835 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-836_e7011f70-9378-473f-9f18-a36f25a44297 13537-836 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROJO DESEO EXOTIC) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-837_e7011f70-9378-473f-9f18-a36f25a44297 13537-837 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (FRAMBUESA MANIA EXOTIC) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-838_e7011f70-9378-473f-9f18-a36f25a44297 13537-838 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (BORGONA SEXY EXOTIC) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-839_e7011f70-9378-473f-9f18-a36f25a44297 13537-839 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (MARRON GLAMOUR EXOTIC) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-840_e7011f70-9378-473f-9f18-a36f25a44297 13537-840 HUMAN OTC DRUG Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25 Octinoxate and Oxybenzone KIT 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD E 20171231 13537-841_4013dd64-05c4-4cba-b138-6884f4027e5c 13537-841 HUMAN OTC DRUG Esika Expression Antiperspirant Roll-on Deodorant ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20161208 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL N 20181231 13537-842_1020561d-d21f-4d42-9286-bb2e3af6d1c1 13537-842 HUMAN OTC DRUG ESIKA VANILLA SCENT ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20161208 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL N 20181231 13537-843_22776198-69db-4037-b621-906dcae13bca 13537-843 HUMAN OTC DRUG ESIKA PASSION MUSK ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20161208 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL N 20181231 13537-844_f13868dc-ff02-47a2-9de4-56c2275f62ad 13537-844 HUMAN OTC DRUG ESIKA MOMENTOS LIBERTAD ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20161208 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL N 20181231 13537-845_d390ab1f-8ae3-4cca-9d59-023927cd2f40 13537-845 HUMAN OTC DRUG ESIKA ALTHEUS ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20161208 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL N 20181231 13537-846_1a820b0c-4c91-4334-977e-a473cf9c98e0 13537-846 HUMAN OTC DRUG ESIKA BRAVIO CHRISTIAN MEIER ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20161208 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL N 20181231 13537-847_af9d60d1-6e09-4cbd-ad07-2356c41332b8 13537-847 HUMAN OTC DRUG ESIKA WINNER SPORT ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20161208 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL N 20181231 13537-848_f37d9f83-6a8b-46d5-bc52-e4da0cb6c8f3 13537-848 HUMAN OTC DRUG ESIKA PULSO CHRISTIAN MEIER ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20161208 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL N 20181231 13537-849_23bdef86-e8ce-4f73-b32a-c68b3b1e8f96 13537-849 HUMAN OTC DRUG ESIKA STRONG MUSK ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20161208 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL N 20181231 13537-850_b794a1c8-35d6-4062-8f85-5c17e627c171 13537-850 HUMAN OTC DRUG ESIKA WINNER BLACK ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20161209 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL N 20181231 13537-851_c45c7218-ef0d-43ce-b130-b693145f8e1c 13537-851 HUMAN OTC DRUG ESIKA ITS YOU ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20161209 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL N 20181231 13537-852_eb15feb7-06e1-41d7-a166-74c3dd75b35c 13537-852 HUMAN OTC DRUG ESIKA ITS YOU LIVE ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20161209 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL N 20181231 13537-853_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-853 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 1 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-854_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-854 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 2 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-855_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-855 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 1 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-856_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-856 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 2 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-857_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-857 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 3 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-858_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-858 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 4 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-859_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-859 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 5 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-860_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-860 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 1 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-861_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-861 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 2 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-862_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-862 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 1 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-863_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-863 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 2 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-864_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-864 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 3 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-865_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-865 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 4 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-866_94012ebd-f114-41a9-abb0-1c285b7e0b8d 13537-866 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 5 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 13537-870_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-870 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE GRANDIOSE) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-871_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-871 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE RUBI) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-872_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-872 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (SOBRIETE) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-873_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-873 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (MARRON ILIMITEE) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-874_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-874 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (CORAL MAXIMUM) - ORANGE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-875_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-875 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROSE TENTATION) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-876_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-876 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROSE CHAMPAGNE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-877_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-877 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROSE DAMOUR) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-878_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-878 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROMANCE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-879_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-879 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (FUCSIA SPLENDIDE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-880_e7011f70-9378-473f-9f18-a36f25a44297 13537-880 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND Coloring SPF 25 (ROJO INTRIGANTE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20161109 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .0664; .0151 g/g; g/g E 20171231 13537-881_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-881 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (FUCSIA DESIR) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-882_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-882 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE PROVOCATION) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-883_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-883 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (CARMINE) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-884_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-884 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (MALBEC) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-885_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-885 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (SALMON ESSENTIAL) - ORANGE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-887_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-887 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (BOURGOGNE VIF) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-888_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-888 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (GENUINE ROUGE) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-889_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-889 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (VIOLET VELVET) - PURPLE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-890_94f03b52-e9a8-4da2-8693-bab180d27b21 13537-890 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (MYSTIC ROSE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .072 g/g E 20171231 13537-891_1a5fda67-78a1-436c-bf44-42c32031e809 13537-891 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MOKA) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-892_1a5fda67-78a1-436c-bf44-42c32031e809 13537-892 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROMANCE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-893_1a5fda67-78a1-436c-bf44-42c32031e809 13537-893 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE NATURAL) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-894_1a5fda67-78a1-436c-bf44-42c32031e809 13537-894 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE CLASIQUE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-895_1a5fda67-78a1-436c-bf44-42c32031e809 13537-895 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROUGE INTENSE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-896_1a5fda67-78a1-436c-bf44-42c32031e809 13537-896 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (AMOUR) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-897_1a5fda67-78a1-436c-bf44-42c32031e809 13537-897 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHOCOLAT) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-898_1a5fda67-78a1-436c-bf44-42c32031e809 13537-898 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ALMOND) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-899_1a5fda67-78a1-436c-bf44-42c32031e809 13537-899 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MALVE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-900_1a5fda67-78a1-436c-bf44-42c32031e809 13537-900 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MARRON GLACE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-901_f1dbc221-70bf-4d21-96ca-701a487185c6 13537-901 HUMAN OTC DRUG LBEL DEFENSE 365 DAILY PROTECTIVE FACIAL SPF 50 Octinoxate, Titanium Dioxide, Homosalate, Octisalate, Oxybenzone, and Zinc Oxide LOTION TOPICAL 20141014 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; HOMOSALATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .07; .062; .05; .05; .04; .039 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 13537-902_1a5fda67-78a1-436c-bf44-42c32031e809 13537-902 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TULIP) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-903_1a5fda67-78a1-436c-bf44-42c32031e809 13537-903 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (LILY BEIGE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-904_1a5fda67-78a1-436c-bf44-42c32031e809 13537-904 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MANDARINE) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-905_1a5fda67-78a1-436c-bf44-42c32031e809 13537-905 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-906_1a5fda67-78a1-436c-bf44-42c32031e809 13537-906 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TEA ROSE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-907_1a5fda67-78a1-436c-bf44-42c32031e809 13537-907 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (FRENESIE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-908_1a5fda67-78a1-436c-bf44-42c32031e809 13537-908 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (RICHE PINK) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-909_1a5fda67-78a1-436c-bf44-42c32031e809 13537-909 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (RED EXTASSY) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-910_1a5fda67-78a1-436c-bf44-42c32031e809 13537-910 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (FUCSIA) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-911_1a5fda67-78a1-436c-bf44-42c32031e809 13537-911 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (SOLEIL) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-912_1a5fda67-78a1-436c-bf44-42c32031e809 13537-912 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TERRE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-913_1a5fda67-78a1-436c-bf44-42c32031e809 13537-913 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHERRY BLOSSOM) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-914_1a5fda67-78a1-436c-bf44-42c32031e809 13537-914 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN AMANT) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-915_1a5fda67-78a1-436c-bf44-42c32031e809 13537-915 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE INTIME) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-916_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-916 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (MARRON GLAMOUR) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-917_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-917 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROJO DESEO) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-918_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-918 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROJO INTRIGANTE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-919_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-919 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROJO LUJURIA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-920_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-920 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (CORAL CHIC) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-921_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-921 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ENCANTO) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-922_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-922 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (BORGONA SEXY) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-923_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-923 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (FUCSIA CAUTIVANTE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-924_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-924 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (GRANATE SEDUCTOR) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-925_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-925 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-926_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-926 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (NARANJA PRIMAVERA) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-927_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-927 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (FRAMBUESA MANIA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-928_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-928 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA DULZURA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-929_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-929 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (PIMIENTA CALIENTE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-930_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-930 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (CANELA NUDE) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-931_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-931 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (MORA GLAM) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-932_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-932 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (CORAL INTENSE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-933_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-933 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (FRESA COQUETA) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-934_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-934 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (PIMIENTA CALIENTE FEMME) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-935_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-935 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (GRANATE SEDUCTOR FEMME) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-936_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-936 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (FUCSIA CAUTIVANTE FEMME) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-937_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-937 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ROMANTICA FEMME) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-938_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-938 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROJO INTRIGANTE FEMME) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-939_fda58319-21c6-4b1e-a9d8-631890685dfe 13537-939 HUMAN OTC DRUG ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 (ROSA ENCANTO FEMME) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140930 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .066; .015 g/g; g/g E 20171231 13537-940_1a5fda67-78a1-436c-bf44-42c32031e809 13537-940 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 13537-941_ce9adf2b-8b57-4854-a413-a33c555d73d8 13537-941 HUMAN OTC DRUG ESIKA ITS YOU LIVE ANTIPERSPIRANT ROLL-ON DEODORANT FM Aluminum sesquichlorohydrate EMULSION TOPICAL 20160428 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-942_750ebf3d-dc96-471e-a762-5aae74beb082 13537-942 HUMAN OTC DRUG CYZONE GIRLINK DESODORANTE ANTITRANSPIRANTE ROLL-ON FM ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160428 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-943_9b314ad0-a338-4616-99c3-25f0f38d608b 13537-943 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 CLAIRE 1- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 13537-944_9b314ad0-a338-4616-99c3-25f0f38d608b 13537-944 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 CLAIRE 2- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 13537-945_9b314ad0-a338-4616-99c3-25f0f38d608b 13537-945 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 CLAIRE 3- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 13537-946_9b314ad0-a338-4616-99c3-25f0f38d608b 13537-946 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 CLAIRE 4- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 13537-947_9b314ad0-a338-4616-99c3-25f0f38d608b 13537-947 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 MEDIUM 5- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 13537-948_9b314ad0-a338-4616-99c3-25f0f38d608b 13537-948 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 MEDIUM 6- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 13537-949_9b314ad0-a338-4616-99c3-25f0f38d608b 13537-949 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 MEDIUM 7- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 13537-950_9b314ad0-a338-4616-99c3-25f0f38d608b 13537-950 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 OBSCURE 8- BROWN Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 13537-951_9b314ad0-a338-4616-99c3-25f0f38d608b 13537-951 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 OBSCURE 9- BROWN Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 13537-952_9b314ad0-a338-4616-99c3-25f0f38d608b 13537-952 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 Octinoxate, Oxybenzone, and Zinc Oxide KIT 20160606 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD N 20181231 13537-953_cbe04a62-2f86-46e1-b802-310d2bb93936 13537-953 HUMAN OTC DRUG CYZONE NITRO DESODORANTE ANTITRANSPIRANTE ROLL-ON NO CONTIENE ALCOHOL FM ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160614 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-954_8eb32983-beff-4f17-bcb3-4087daf1979c 13537-954 HUMAN OTC DRUG ESIKA ALTHEUS FOR MEN ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160705 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-955_5985bb35-ccab-4f83-867f-6eda4e4b5844 13537-955 HUMAN OTC DRUG ESIKA CARDIGAN ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160705 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-956_46d1a340-88cc-4cad-a6b0-7b6b2f7d3af6 13537-956 HUMAN OTC DRUG LBEL DRY EFFECT 48 ANTIPERSPIRANT DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160705 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .18 g/mL E 20171231 13537-957_d54bc18b-2bf0-4f36-a596-2b81ef4957f7 13537-957 HUMAN OTC DRUG LBEL ESSENTIAL Deep moisturizing and oxygenating SPF 20 normal to oily skin Avobenzone, Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20160708 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .03; .05; .06 g/mL; g/mL; g/mL; g/mL E 20171231 13537-958_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-958 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (PIMIENTA CALIENTE) - BROWN OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-959_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-959 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (ROJO DESEO) - RED OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-960_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-960 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (ROJO ESIKA) - RED OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-961_665f8985-60a6-434b-a97b-64d220f4db02 13537-961 HUMAN OTC DRUG ESIKA EXPRESSION ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160708 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-962_5b55a758-f037-431b-b719-95eb0cf61996 13537-962 HUMAN OTC DRUG ESIKA MAX ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160711 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-963_78c18513-35a6-45df-93cb-ba5c1ab0655a 13537-963 HUMAN OTC DRUG CYZONE NITRO DESODORANTE ANTITRANSPIRANTE ROLL-ON FM ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160711 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .136 g/mL E 20171231 13537-964_65398e34-dec1-4aa1-a4a6-d6533319eca6 13537-964 HUMAN OTC DRUG ESIKA TOTAL SEC NEUTRAL FRAGRANCE ANTIPERSPIRANT AND DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160712 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .16 g/mL N 20181231 13537-965_d67c1ab7-4ddf-4168-8448-bd7a624508ee 13537-965 HUMAN OTC DRUG ESIKA TOTAL SEC DELICATE SKIN ANTIPERSPIRANT AND DEODORANT ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160712 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .16 g/mL N 20181231 13537-966_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-966 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (MARRON TOPACIO) - BROWN OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-967_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-967 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (ROSA GEOMETRIC) - PINK OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-968_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-968 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (ROSA ENCANTO) - PINK OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-969_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-969 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (MORA GLAM) - PURPLE OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-970_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-970 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (GRANATE SEDUCTOR) - PURPLE OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-971_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-971 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (BORGONA SEXY) - PURPLE OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-972_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-972 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (FRESA HOT) - PINK OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-973_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-973 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (FUCSIA CAUTIVANTE) - PINK OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-974_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-974 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (FUCSIA INTENSE) - PINK OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-975_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-975 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (NARANJA ESFERA) - ORANGE OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-976_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-976 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (ROSA NUDE) - PINK OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-977_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-977 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (PEACH NUDE) - BROWN OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-978_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-978 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (CORAL CHIC) - PINK OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-979_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-979 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (ROJO TROPICAL) - RED OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-980_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-980 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (NARANJA CITRICO) - ORANGE OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-981_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-981 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (NUDE PUNCH) - ORANGE OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-982_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-982 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (MORA ATREVIDA) - PURPLE OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-983_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-983 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (NUDE SAVANNA) - ORANGE OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-984_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-984 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (ROJO SENSUAL) - RED OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-985_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-985 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (NUDE MOCCHA) - ORANGE OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-986_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-986 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 (BRONCE METALLIC) - BROWN OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 13537-987_ffd14636-72ae-404b-9d11-cc76415c6e56 13537-987 HUMAN OTC DRUG ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25 OCTINOXATE and ZINC OXIDE KIT 20160712 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD DUNS N 20181231 13537-988_d9a49187-70ae-457f-8bad-3b5512ec3b0a 13537-988 HUMAN OTC DRUG ESIKA PERFECTBLOCK MULTIPROTECTOR SOLAR DE AMPLIO ESPECTRO PARA ROSTRO Y CUERPO FPS 50PLUS Avobenzone, Homosalate, and Octocrylene LOTION TOPICAL 20160713 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; HOMOSALATE; OCTOCRYLENE .03; .1; .08 g/mL; g/mL; g/mL E 20171231 13537-989_31e7036c-7e8a-4562-b2eb-b3999df271e5 13537-989 HUMAN OTC DRUG CYZONE XPRESS YOUR BODY CLARITY ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160809 OTC MONOGRAPH FINAL part350 Ventura Corporation LTD ALUMINUM SESQUICHLOROHYDRATE .16 g/mL E 20171231 13537-990_5a9954a0-5827-4073-b8fd-19f2d8c96769 13537-990 HUMAN OTC DRUG LBEL DEFENSE TOTAL broad spectrum SPF 50plus sunscreen for face and body Avobenzone, Homosalate, and Octocrylene LOTION TOPICAL 20160823 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; HOMOSALATE; OCTOCRYLENE .03; .1; .08 g/mL; g/mL; g/mL N 20181231 13537-991_1de085f7-dee6-4a0c-991f-4f4511cdbd4e 13537-991 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (CLAIRE 1) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150817 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 13537-992_1de085f7-dee6-4a0c-991f-4f4511cdbd4e 13537-992 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (CLAIRE 2) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150817 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 13537-993_83f0a424-ff93-471b-8702-1d8d20f6168b 13537-993 HUMAN OTC DRUG Brightening and moisturizing facial SPF 30 Avobenzone, Ensulizole, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part352 Ventura Corporation LTD AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .03; .05; .05; .06 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 13537-994_afb5e17f-2935-42ff-b935-fcff453ef202 13537-994 HUMAN OTC DRUG LBEL LEDERM 45 plus JOUR Facial against noticeable signs of aging Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20161024 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/mL; g/mL; g/mL; g/mL N 20181231 13537-995_e8214ec2-fda9-4992-b832-42db3bad25f8 13537-995 HUMAN OTC DRUG LBEL LEDERM 35 plus JOUR Facial against first signs of aging Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20161024 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/mL; g/mL; g/mL; g/mL N 20181231 13537-996_b5553845-bce8-4ef6-949f-197db9a9b463 13537-996 HUMAN OTC DRUG ESIKA TRIPLE ACCION MAX BB CREMA FACIAL PERFECCIONADORA CON COLOR FPS 30 6 BENEFICIOS EN 1 CLARO (BEIGE) Octinoxate and Zinc Oxide LOTION TOPICAL 20160823 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .084 g/g; g/g E 20171231 13537-997_b5553845-bce8-4ef6-949f-197db9a9b463 13537-997 HUMAN OTC DRUG ESIKA TRIPLE ACCION MAX BB CREMA FACIAL PERFECCIONADORA CON COLOR FPS 30 6 BENEFICIOS EN 1 MEDIO (BROWN) Octinoxate and Zinc Oxide LOTION TOPICAL 20160823 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .084 g/g; g/g E 20171231 13537-998_30e22a5f-1790-45f5-af6a-7b815b50acf1 13537-998 HUMAN OTC DRUG ESIKA TRIPLE ACCION MAX BB Dark Beige Zinc Oxide and Octinoxate CREAM TOPICAL 20140310 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE; OCTINOXATE .084; .07 g/g; g/g E 20171231 13537-999_30e22a5f-1790-45f5-af6a-7b815b50acf1 13537-999 HUMAN OTC DRUG ESIKA TRIPLE ACCION MAX BB Light Beige Zinc Oxide and Octinoxate CREAM TOPICAL 20140310 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD ZINC OXIDE; OCTINOXATE .084; .07 g/g; g/g E 20171231 13548-010_520ec619-4fd5-433e-b7cd-0265fe16e7cc 13548-010 HUMAN PRESCRIPTION DRUG Salex Salicylic acid CREAM TOPICAL 20040601 UNAPPROVED DRUG OTHER Coria Laboratories SALICYLIC ACID 60 mg/g N 20181231 13548-011_520ec619-4fd5-433e-b7cd-0265fe16e7cc 13548-011 HUMAN PRESCRIPTION DRUG Salex Salicylic acid LOTION TOPICAL 20041001 UNAPPROVED DRUG OTHER Coria Laboratories SALICYLIC ACID 60 mg/mL N 20181231 13548-012_c4a0374e-cc73-4366-866f-1265c14e87fc 13548-012 HUMAN PRESCRIPTION DRUG Salex Salicylic acid SHAMPOO TOPICAL 20041001 UNAPPROVED DRUG OTHER Coria Laboratories SALICYLIC ACID 60 mg/mL N 20181231 13548-070_8a700509-6831-47d2-926a-105ce625ce60 13548-070 HUMAN PRESCRIPTION DRUG Atralin Tretinoin GEL TOPICAL 20070726 NDA NDA022070 Coria Laboratories TRETINOIN .05 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 13548-132_f0ecc3ca-ee50-4cd7-87a0-bd931dc93604 13548-132 HUMAN PRESCRIPTION DRUG ACANYA Clindamycin Phosphate and Benzoyl Peroxide GEL TOPICAL 20100726 NDA NDA050819 Valent Pharmaceuticals North America CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE 10; 25 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 13551-101_536502b7-5e0c-4f0a-a3bd-c0f58979390b 13551-101 HUMAN PRESCRIPTION DRUG Karbinal ER Carbinoxamine Maleate SUSPENSION, EXTENDED RELEASE ORAL 20140103 NDA NDA022556 Avadel Pharmaceuticals (USA), Inc. CARBINOXAMINE MALEATE 4 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 13551-125_bbda1192-3918-458c-9508-6ef2bfa25325 13551-125 HUMAN PRESCRIPTION DRUG Cefaclor cefaclor FOR SUSPENSION ORAL 20151026 ANDA ANDA065412 Avadel Pharmaceuticals (USA), Inc. CEFACLOR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 13551-205_e99f6bdd-778c-4f46-92d2-d448948f2a44 13551-205 HUMAN PRESCRIPTION DRUG AcipHex Sprinkle rabeprazole sodium CAPSULE, DELAYED RELEASE ORAL 20141001 NDA NDA204736 Avadel Pharmaceuticals (USA), Inc. RABEPRAZOLE SODIUM 5 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 13551-210_e99f6bdd-778c-4f46-92d2-d448948f2a44 13551-210 HUMAN PRESCRIPTION DRUG AcipHex Sprinkle rabeprazole sodium CAPSULE, DELAYED RELEASE ORAL 20141001 NDA NDA204736 Avadel Pharmaceuticals (USA), Inc. RABEPRAZOLE SODIUM 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 13551-250_bbda1192-3918-458c-9508-6ef2bfa25325 13551-250 HUMAN PRESCRIPTION DRUG Cefaclor cefaclor FOR SUSPENSION ORAL 20151026 ANDA ANDA065412 Avadel Pharmaceuticals (USA), Inc. CEFACLOR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 13551-375_bbda1192-3918-458c-9508-6ef2bfa25325 13551-375 HUMAN PRESCRIPTION DRUG Cefaclor cefaclor FOR SUSPENSION ORAL 20151026 ANDA ANDA065412 Avadel Pharmaceuticals (USA), Inc. CEFACLOR 375 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 13551-501_0cc7d685-5819-4103-b667-375e23299dd8 13551-501 HUMAN PRESCRIPTION DRUG Primsol trimethoprim hydrochloride SOLUTION ORAL 20000124 NDA NDA074973 FSC Laboratories, Inc TRIMETHOPRIM HYDROCHLORIDE 50 mg/5mL Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 13551-701_fc4bf594-67d6-4daa-8f7a-efc43a964da4 13551-701 HUMAN PRESCRIPTION DRUG ProCentra dextroamphetamine sulfate LIQUID ORAL 20100801 ANDA ANDA040776 FSC Laboratories, Inc DEXTROAMPHETAMINE SULFATE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 13630-0008_9ab6493c-3abe-4c20-aad8-c03c2d403263 13630-0008 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 4 Avobenzone, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120321 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 4.03; 8.06; 4.03 mg/mL; mg/mL; mg/mL N 20181231 13630-0012_79c0062f-91f0-4179-9880-e1ee11c4fa00 13630-0012 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120118 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 16.6; 62.3; 41.6; 22.9; 16.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0013_a6091ccd-8043-4cc1-a285-0f71ee21c422 13630-0013 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120103 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 16.9; 63.3; 42.2; 23.2; 16.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0014_669dfd50-24a4-4bd0-9962-39dc675eaf4f 13630-0014 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120410 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.7; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0015_da5ea691-6561-4c28-9fd4-517e370bd761 13630-0015 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120410 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.7; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0016_d658ea22-6c45-46e6-ba6b-62e181d0d0db 13630-0016 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20111101 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 16.7; 62.6; 41.8; 22.9; 16.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0017_77c86c57-70fe-4aff-b0b5-275e92416947 13630-0017 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20121027 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.2; 40.5; 22.3 mg/mL; mg/mL; mg/mL N 20181231 13630-0018_652e8319-c760-439d-8afc-853bcd04d4dd 13630-0018 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20120614 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.7; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0019_3c05c254-92a5-4470-972e-df2d53f196ca 13630-0019 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 4 Avobenzone, Octocrylene and Oxybenzone SPRAY TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 8.4; 7.1; 4.2 mg/mL; mg/mL; mg/mL N 20181231 13630-0020_da41b578-3338-47c9-86ce-be015c55b740 13630-0020 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20131023 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 8.4; 25.1; 7.2; 8.4 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0021_d3e3c89b-099b-4ea4-8ee8-a6bd56a67c9d 13630-0021 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene SPRAY TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.8; 42; 15.5 mg/mL; mg/mL; mg/mL N 20181231 13630-0022_46ce6a33-7cb7-4921-aeac-0eb3336ced5e 13630-0022 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene SPRAY TOPICAL 20131031 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.3; 40.7; 15 mg/mL; mg/mL; mg/mL N 20181231 13630-0023_96cb63db-bbf3-4315-bd86-d388ef089849 13630-0023 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20131023 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.1; 62.6; 41.7; 23; 16.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0024_6cee9c44-1927-48e6-8cc9-baeae6d6dc5f 13630-0024 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20131106 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.1; 62.7; 41.8; 23; 16.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0025_7b862e51-7fce-45a3-85d4-92b1e22256d7 13630-0025 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20131029 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.2; 84; 42; 23.1; 33.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0026_1efd5beb-ab7c-48d1-a3e6-4095dea58b56 13630-0026 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20131029 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.2; 84; 42; 23.1; 33.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0027_3ec2a7d7-eec6-4b68-986b-b47488ebe394 13630-0027 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20120614 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.8; 86; 43; 23.7; 34.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0028_640ec9fd-2fac-4628-9de5-9ee633464896 13630-0028 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene SPRAY TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.8; 42; 15.5 mg/mL; mg/mL; mg/mL N 20181231 13630-0029_4a571818-e554-4d6b-8fe8-86dd526a0e97 13630-0029 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20111230 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 24.9; 62.3; 41.5; 27.5; 16.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0030_1f409752-03ce-44e6-8943-5cd1cc8f9653 13630-0030 HUMAN OTC DRUG Panama Jack SPF 15 Ocinoxate, Octisalate, and Oxybenzone SPRAY TOPICAL 20111230 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 40.8; 24.5; 16.3 mg/mL; mg/mL; mg/mL N 20181231 13630-0031_6b468065-40b6-4e45-9903-e730e97d8290 13630-0031 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20120104 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 16.7; 62.6; 41.8; 22.9; 16.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0032_b97a4809-4b6c-4745-be62-33d2e9fc7a17 13630-0032 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20120104 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 16.7; 62.6; 41.8; 22.9; 16.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0033_04ce72fa-e390-46f3-a36e-4cc7c06cfcd3 13630-0033 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20120109 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25; 83.4; 41.7; 22.9; 33.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0034_21364fea-0e9d-4f64-bfa7-f9a98a8f3394 13630-0034 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120109 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25; 83.4; 41.7; 22.9; 33.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0035_2a18bbf3-3e26-46d9-bdcd-ed4503988034 13630-0035 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120109 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25; 83.4; 41.7; 22.9; 33.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0036_5f9530b4-df56-451f-90c4-cedb9f1849e8 13630-0036 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120221 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 106.8; 42.7; 23.5; 51.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0037_932c54e9-f5da-410a-b6e4-daf614b83c7f 13630-0037 HUMAN OTC DRUG Aloe Up Broad Spectrum SPF 15 Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20130301 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.1; 40.3; 14.9 mg/mL; mg/mL; mg/mL N 20181231 13630-0038_2a181405-0a45-492c-a0ee-332ad07d9c62 13630-0038 HUMAN OTC DRUG Aloe Up Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130301 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 63.9; 42.7; 23.6; 17.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0039_3ce61a63-446d-4e74-9309-b83444908da9 13630-0039 HUMAN OTC DRUG Aloe Up Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130301 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.8; 85.8; 42.9; 23.6; 34.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0040_cc49aa36-6275-4a23-b776-40bcc6c85cd9 13630-0040 HUMAN OTC DRUG Aloe Up Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130417 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.8; 85.8; 42.9; 23.6; 34.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0041_40bd6bdf-69bd-4818-a584-ee983188e7d6 13630-0041 HUMAN OTC DRUG Aloe Up Dark Tanning Oil SPF 4 Octinoxate and Oxybenzone SPRAY TOPICAL 20090105 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. OCTINOXATE; OXYBENZONE 16.6; 16.6 mg/mL; mg/mL N 20181231 13630-0042_dde71ef8-2dce-483a-a044-30238d9d8623 13630-0042 HUMAN OTC DRUG Ulta SPF30 Homosalate, Octinoxate, Octisalate, and Oxybenzone SPRAY TOPICAL 20070423 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 42; 63; 43; 33.6 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0043_517f1020-02d2-432b-92c1-7ce5b67e2506 13630-0043 HUMAN OTC DRUG Ulta SPF 15 Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20081126 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.7; 41.8; 22.9 mg/mL; mg/mL; mg/mL N 20181231 13630-0044_7d2cbb2c-5a5b-4dd1-b9b6-2dac0865af3d 13630-0044 HUMAN OTC DRUG Ulta Broad Spectrum SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20081126 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.9; 108.1; 43.3; 23.8; 51.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0045_469d41d4-2714-467c-8c95-fbdd1a381313 13630-0045 HUMAN OTC DRUG Sunzen Broad Spectrum SPF 8 Avobenzone, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130321 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 8.2; 24.6; 6.97; 8.2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0046_7142e1f9-f1ff-4a8d-9201-25dffe4678e1 13630-0046 HUMAN OTC DRUG Suntone Broad Spectrum SPF 8 Avobenzone, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130321 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 8.1; 24.3; 6.9; 8.1 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0047_52feb811-b37c-4995-b084-392e22e897c0 13630-0047 HUMAN OTC DRUG Suntone Broad Spectrum SPF 4 Avobenzone, Octocrylene and Oxybenzone SPRAY TOPICAL 20130321 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 8.4; 7.1; 4.2 mg/mL; mg/mL; mg/mL N 20181231 13630-0048_0fa468ab-c6c8-4a63-ac4f-ab0ea2d3abdc 13630-0048 HUMAN OTC DRUG SOLMATE Broad Spectrum SPF 4 Avobenzone, Octocrylene and Oxybenzone SPRAY TOPICAL 20130321 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 8.2; 6.9; 4.1 mg/mL; mg/mL; mg/mL N 20181231 13630-0049_fb837a81-289d-4d1b-8265-60973e91f0da 13630-0049 HUMAN OTC DRUG SUNZEN Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 63.9; 42.7; 23.5; 17.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0050_ad7fd343-9452-4586-b099-ea503c9884f3 13630-0050 HUMAN OTC DRUG SolMate Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 63.9; 42.7; 23.5; 17.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0051_5cf97828-6ea9-41ec-b5b6-1b0ef7003d61 13630-0051 HUMAN OTC DRUG SOLMATE Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 63.9; 42.7; 23.5; 17.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0052_b9529c8e-1110-4d67-a90c-494dc40df3dd 13630-0052 HUMAN OTC DRUG SOLMATE Broad Spectrum SPF 30 Avobenzone, Homsalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 63.9; 42.7; 23.5; 17.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0053_23e74dc6-598e-40b6-a7d9-7c693410a332 13630-0053 HUMAN OTC DRUG SOLMATE Broad Spectrum SPF 30 Avobenzone, Homsalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130430 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 63.9; 42.7; 23.5; 17.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0054_adeb1ebd-ec64-4867-a3a2-2f22b45f505b 13630-0054 HUMAN OTC DRUG SolMate Broad Spectrum SPF 15 Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20130403 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.3; 40.8; 22.4 mg/mL; mg/mL; mg/mL N 20181231 13630-0055_39d5ec55-0b43-4fe4-9fd3-895f07bb1992 13630-0055 HUMAN OTC DRUG Sunzen Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130416 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.5; 85; 42.5; 23.4; 34 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0056_74887c03-7ea2-4ad3-b415-ceaf34b66271 13630-0056 HUMAN OTC DRUG SolMate Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.7; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0057_5bd5b714-cae7-4741-aa36-df0703ebc409 13630-0057 HUMAN OTC DRUG SolMate Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20120423 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.7; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0058_1706f684-458b-4fb5-88e3-4ad42fd275c3 13630-0058 HUMAN OTC DRUG SolMate Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20120416 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.7; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0059_3bdf4b45-49b0-44e3-944d-08f473d08706 13630-0059 HUMAN OTC DRUG Suntone Broad Spectrum SPF 15 Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20130405 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.2; 40.5; 14.9 mg/mL; mg/mL; mg/mL N 20181231 13630-0060_f8efdefb-e18c-4b5f-8f88-e6bb4f69b36d 13630-0060 HUMAN OTC DRUG SolMate Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20120416 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.1; 100.2; 50.1; 27.6; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0061_ad609064-f4d9-4bbf-9be9-072b948c0830 13630-0061 HUMAN OTC DRUG California Tan Broad Spectrum SPF 8 Avobenzone, Octocrylene and Oxybenzone SPRAY TOPICAL 20111128 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 8.1; 22.2; 8.1 mg/mL; mg/mL; mg/mL N 20181231 13630-0062_2b908d4d-4997-4c8c-8563-5432fb762c13 13630-0062 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Octobenzone SPRAY TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 24.8; 62.1; 41.4; 22.8; 16.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0063_af5f8657-96ff-420a-92d1-7bd3e0aa4e0f 13630-0063 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.5; 84.9; 42.5; 23.4; 34 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0064_64d8c602-d820-437f-9c5c-39700e7f90cf 13630-0064 HUMAN OTC DRUG California Tan Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene SPRAY TOPICAL 20111228 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16; 40.3; 22.2 mg/mL; mg/mL; mg/mL N 20181231 13630-0065_dc8daabf-881f-4a71-be54-9c9fb52a60c6 13630-0065 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octocrylene, and Oxybenzone SPRAY TOPICAL 20120425 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 8.2; 22.5; 8.2 mg/mL; mg/mL; mg/mL N 20181231 13630-0066_f80c8ef8-6456-47cd-bfe6-04d3a07de366 13630-0066 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene SPRAY TOPICAL 20120111 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OCTISALATE 16.3; 22.4; 40.8 mg/mL; mg/mL; mg/mL N 20181231 13630-0067_529a0a66-1015-4b76-b59d-57375bf021f9 13630-0067 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene SPRAY TOPICAL 20120103 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OCTISALATE 16.3; 22.4; 40.8 mg/mL; mg/mL; mg/mL N 20181231 13630-0068_eb99d2c3-8bce-4265-8605-ce21750aa8d3 13630-0068 HUMAN OTC DRUG Ulta Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene SPRAY TOPICAL 20131217 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTOCRYLENE; OCTISALATE 16.2; 14.9; 40.5 mg/mL; mg/mL; mg/mL N 20181231 13630-0069_c9074237-6dbf-4257-bee5-68b84cb160a5 13630-0069 HUMAN OTC DRUG Ulta Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20031217 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 16.3; 22.4; 22.4; 22.4; 40.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0070_9ea3962f-2503-40b7-9971-74f26dc131d9 13630-0070 HUMAN OTC DRUG Ulta Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20131217 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.4; 84.8; 42.4; 23.3; 33.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0071_486db467-683f-4c3b-a1b6-a8c2086b3cfe 13630-0071 HUMAN OTC DRUG Australian Gold Broad Spectrum 30 Avobenzone, Homoslate, Octisalate ,Octocrylene and Oxybenzone SPRAY TOPICAL 20131219 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.6; 66.5; 44.4; 24.4; 17.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0072_6ef78b33-abef-4dfa-ac76-be5068731536 13630-0072 HUMAN OTC DRUG Raydiant by Australian Gold Broad Spectrum SPF 30 Vitamin D Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20150131 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 24.9; 62.25; 41.5; 22.825; 16.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0073_46a6788c-947c-4ca7-b832-a8cacc3f0c22 13630-0073 HUMAN OTC DRUG RAYDIANT by Australian Gold BROAD SPECTRUM SPF 50 Vitamin D Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20150131 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.5; 85; 42.5; 23.375; 34 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0074_5527575c-1d9e-4057-9bec-aedf356da228 13630-0074 HUMAN OTC DRUG BLI Holding Miami Beach kids spf 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone AEROSOL, SPRAY TOPICAL 20150301 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.33; 101.1; 50.55; 27.8025; 20.22 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0075_6e7e0a2e-9014-4541-adbe-52111d986bcd 13630-0075 HUMAN OTC DRUG SolMate broad spectrum spf 8 Avobenzone, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20150301 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 8.1; 24.3; 6.885; 8.1 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0076_c16e539f-8869-40e3-ad66-d0374442741d 13630-0076 HUMAN OTC DRUG SolScents flower blast broad spectrum spf 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20150301 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.8; 86; 43; 23.65; 34.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0077_a99b9488-e072-4061-973b-b8cf4def492c 13630-0077 HUMAN OTC DRUG SolScents Deep Love broad spectrum spf 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20150301 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.2; 63; 42; 23.1; 16.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0078_0b90c3ac-cd20-41bb-b275-9c106ece78f9 13630-0078 HUMAN OTC DRUG California Tan SPF 45 Face Sunscreen Avobenzone, Homosalate, Octisalate, and Octocrylene AEROSOL, FOAM TOPICAL 20131230 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 300; 1500; 500; 275 g/g; g/g; g/g; g/g N 20181231 13630-0079_3bb73957-f863-4dd6-91b0-1b1efb57d983 13630-0079 HUMAN OTC DRUG California Tan SPF 30 BROAD SPECTRUM Sunscreen Avobenzone, Homosalate, Octisalate, and Octocrylene AEROSOL, FOAM TOPICAL 20131230 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 300; 1000; 500; 275 g/g; g/g; g/g; g/g N 20181231 13630-0080_c89f207b-03d2-4890-bcd0-355049648652 13630-0080 HUMAN OTC DRUG Fair and Square Ultra Protection Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Oxybenzone AEROSOL, SPRAY TOPICAL 20140228 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 16.1; 80.3; 40.2; 24.1 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0081_9103e9da-a388-42cf-981d-1ea3f76b0bd2 13630-0081 HUMAN OTC DRUG Fair and Square Ultra Protection Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, and Oxybenzone AEROSOL, SPRAY TOPICAL 20140228 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 16.2; 121.8; 40.6; 32.5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0082_b3e3a70e-f850-40db-8eaa-e106ec8146d6 13630-0082 HUMAN OTC DRUG Fair and Square Kids Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, and Oxybenzone AEROSOL, SPRAY TOPICAL 20140228 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 24.7; 123.6; 41.2; 49.4 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0083_b3c83c6a-d67d-4839-afd5-952b2a51c6a8 13630-0083 HUMAN OTC DRUG Fair and Square Sport Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, and Oxybenzone AEROSOL, SPRAY TOPICAL 20140228 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 24.7; 123.6; 41.2; 49.4 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0084_db16a8da-0f46-472f-844f-b122fd4a6b8d 13630-0084 HUMAN OTC DRUG Fair and Square Sport Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, and Oxybenzone AEROSOL, SPRAY TOPICAL 20140228 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 24.7; 81.2; 40.6; 32.5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0085_608bfa34-7594-494b-bcb1-d96c999bc8d4 13630-0085 HUMAN OTC DRUG Panama Jack SPF 8 with instant bronzer Ocinoxate and Oxybenzone AEROSOL, SPRAY TOPICAL 20111229 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. OCTINOXATE; OXYBENZONE 19.6; 19.6 mg/mL; mg/mL N 20181231 13630-0086_2a4a5d19-256c-4773-9b80-69f35aee5608 13630-0086 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 with invisidry Technology Avovenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20121022 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.8; 64.5; 43; 23.7; 17.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0087_506f80d4-fd60-4541-b131-4ec93a0e2ecf 13630-0087 HUMAN OTC DRUG Australian Gold Hello Kitty Broad Spectrum 50 Avobenzone, Homoslate, Octisalate ,Octocrylene and Oxybenzone AEROSOL, SPRAY TOPICAL 20131225 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.7; 89; 44.5; 24.5; 35.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0088_51316aa2-727c-4f71-ae06-75d9bcab6a80 13630-0088 HUMAN OTC DRUG Australian Gold Invisidry Technology Oil-Free Formula Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL TOPICAL 20110617 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 24.9; 62.55; 41.5; 22.83; 16.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0089_7bf8648c-e429-4da7-8218-84e0b1044fe0 13630-0089 HUMAN OTC DRUG Occulus Soloxide 30 Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL TOPICAL 20150801 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75; 50; 275; 20 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 13630-0090_7db423a6-edb6-4998-99c5-e697a9a993b8 13630-0090 HUMAN OTC DRUG Occulus SKIN HYDRATING TOPICAL FOAM CLO-1 ANTIFUNGAL FOAM Clotrimazole AEROSOL, FOAM TOPICAL 20150801 OTC MONOGRAPH FINAL part333C Prime Packaging, Inc. CLOTRIMAZOLE 10 mg/g N 20181231 13630-0091_9fd39563-fb02-4e15-9b36-196bb5c5a18c 13630-0091 HUMAN OTC DRUG MKRS Broad Spectrum SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20150801 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29; 96; 48; 26.4; 38.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0092_21d9db2a-2018-48bb-a97e-0e0cedb6ca42 13630-0092 HUMAN OTC DRUG Occulus Skin Hydrating Topical Foam CLO-1 Clotrimazole AEROSOL, FOAM TOPICAL 20150801 OTC MONOGRAPH FINAL part333C Prime Packaging, Inc. CLOTRIMAZOLE 10 mg/g N 20181231 13630-0093_1fcebe22-28f9-0079-e054-00144ff8d46c 13630-0093 HUMAN OTC DRUG ALOE UP BROAD SPECTRUM SPF 50 avobenzone, homosalate, octisalate and octocrylene SPRAY TOPICAL 20150825 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 24; 120; 40; 22 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0094_1fdddf44-4c57-4760-e054-00144ff8d46c 13630-0094 HUMAN OTC DRUG Aloe Up Broad Spectrum SPF 30 avobenzone, homosalate, octisalate, and octocrylene SPRAY TOPICAL 20150727 OTC MONOGRAPH FINAL part352 Prime Packaging, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 24.9; 83; 41.5; 22.83 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0095_205c42c1-6830-4e70-e054-00144ff88e88 13630-0095 HUMAN OTC DRUG ALOE UP BROAD SPECTRUM SPF 30 avobenzone, homosalate, octisalate and octocrylene SPRAY TOPICAL 20150727 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 24.9; 83; 41.5; 22.8 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0096_205ca3c3-61cf-59e7-e054-00144ff88e88 13630-0096 HUMAN OTC DRUG Prebel Nude Protect SPF 70 Sunscreen avobenzone, homosalate, octisalate, oxybenzone and octocrylene SPRAY TOPICAL 20120307 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.6; 106.5; 42.6; 23.43; 51.12 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0097_27f962fc-fc22-1c6b-e054-00144ff88e88 13630-0097 HUMAN OTC DRUG Aloe Up SPF 30 C/S Sunscreen with Aloe Vera avobenzone, homosalate, octisalate, and octocrylene SPRAY TOPICAL 20151228 OTC MONOGRAPH FINAL part352 Prime Packaging Inc HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 83; 41.5; 22.83; 24.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0098_2885dfb1-dd16-17e5-e054-00144ff88e88 13630-0098 HUMAN OTC DRUG Aloe Up SPF 30 C/S Sunscreen with Aloe Vera avobenzone, homosalate, octisalate, and octocrylene SPRAY TOPICAL 20151228 OTC MONOGRAPH FINAL part352 Prime Packaging Inc HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 127.5; 42.5; 23.38; 25.5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0099_289a99b3-8513-72c7-e054-00144ff8d46c 13630-0099 HUMAN OTC DRUG Solmate Broad Spectrum SPF 50 C/S Sunscreen avobenzone, homosalate, octisalate, oxybenzone and octocrylene SPRAY TOPICAL 20160201 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.5; 85; 42.5; 23.38; 34 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0100_28d6d853-513b-219e-e054-00144ff8d46c 13630-0100 HUMAN OTC DRUG Solmate Broad Spectrum SPF 50 C/S Sunscreen avobenzone, homosalate, octisalate, oxybenzone and octocrylene SPRAY TOPICAL 20160201 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.5; 85; 42.5; 23.38; 34 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0101_28d816e7-3b9b-2014-e054-00144ff88e88 13630-0101 HUMAN OTC DRUG Australian Gold SPF 15 C/S Sunscreen with Bronzer Avobenzone, octisalate, and octocrylene SPRAY TOPICAL 20160201 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.2; 40.5; 15 mg/mL; mg/mL; mg/mL N 20181231 13630-0102_2af9fdbf-1d64-675d-e054-00144ff8d46c 13630-0102 HUMAN OTC DRUG Australian Gold Mermaid SPF 50 Glitter Sunscreen Avobenzone, homosalate, octisalate, octocrylene, and oxybenzone SPRAY TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.04; 86.8; 43.4; 23.87; 34.72 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0103_2bd66d7a-b543-03c3-e054-00144ff88e88 13630-0103 HUMAN OTC DRUG Miami Beach SPF 50 Kids C/S Sunscreen avobenzone, homosalate, octisalate, and octocrylene SPRAY TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.27; 100.9; 50.45; 27.75 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0104_2bd8159f-c382-36b3-e054-00144ff88e88 13630-0104 HUMAN OTC DRUG Miami Beach SPF 50 Kids C/S Sunscreen avobenzone, homosalate, octisalate, and octocrylene SPRAY TOPICAL 20160229 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30.66; 102.2; 51.1; 28.11 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0105_2fe5bc4f-6e86-56ab-e054-00144ff88e88 13630-0105 HUMAN OTC DRUG Australian Gold X-treme Sport SPF 30 C/S Sunscreen Avobenzone, homosalate, octisalate, octocrylene, and oxybenzone SPRAY TOPICAL 20160407 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.2; 63; 42; 23.1; 16.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0106_33469c93-c356-32ef-e054-00144ff8d46c 13630-0106 HUMAN OTC DRUG Defense Zone Sport C/S Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20160509 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 24.6; 123; 41; 49.2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0107_3382ed6a-ebb9-6860-e054-00144ff8d46c 13630-0107 HUMAN OTC DRUG Defense Zone Kids C/S Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20160509 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 24.6; 123; 41; 49.2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0108_3398af9c-c5af-086b-e054-00144ff8d46c 13630-0108 HUMAN OTC DRUG Defense Zone Sport C/S Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20160511 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 24.1; 80.2; 40.1; 32.1 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0109_339a3e2b-b527-5487-e054-00144ff8d46c 13630-0109 HUMAN OTC DRUG Defense Zone C/S Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20160509 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 16.2; 121.8; 40.6; 32.5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0110_36fb1fec-f108-6d2f-e054-00144ff88e88 13630-0110 HUMAN OTC DRUG Australian Gold Botanical Sunscreen Broad Spectrum SPF 30 Natural Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY TOPICAL 20160715 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 26.04; 86.8; 43.4; 23.87 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0111_36fd4a60-710d-1332-e054-00144ff8d46c 13630-0111 HUMAN OTC DRUG Australian Gold Botanical Sunscreen Broad Spectrum SPF 50 Natural Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY TOPICAL 20160715 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 25.83; 129.15; 43.05; 23.68 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0112_37867c19-8fd3-337e-e054-00144ff88e88 13630-0112 HUMAN OTC DRUG California Tan Continuous Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20151230 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 16.5; 62; 41.3; 22.7; 16.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0113_3788e8b6-aba3-1513-e054-00144ff88e88 13630-0113 HUMAN OTC DRUG SolMate Continuous Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20160206 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.2; 40.5; 15 mg/mL; mg/mL; mg/mL N 20181231 13630-0114_39a99995-9149-6a39-e054-00144ff8d46c 13630-0114 HUMAN OTC DRUG KVG Group, Inc. FXP Cracked Heel Formula Dimethicone SPRAY TOPICAL 20140521 OTC MONOGRAPH FINAL part347 Prime Packaging Inc. DIMETHICONE 10.2 mg/mL N 20181231 13630-0115_3a591d66-dd9b-26d7-e054-00144ff8d46c 13630-0115 HUMAN OTC DRUG Soleil Toujours SPF 50 Sheer Sunscreen Mist Avobenzone, Homosalate, Octisalate SPRAY TOPICAL 20160817 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE 25.8; 86.1; 43.1 mg/mL; mg/mL; mg/mL N 20181231 13630-0116_3a5cdb1a-4862-6446-e054-00144ff8d46c 13630-0116 HUMAN OTC DRUG Soleil Toujours SPF 50 Sheer Sunscreen Mist Avobenzone, Homosalate, Octisalate SPRAY TOPICAL 20160817 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE 25.17; 62.93; 41.95 mg/mL; mg/mL; mg/mL N 20181231 13630-0117_406c31f2-4ce5-1371-e054-00144ff8d46c 13630-0117 HUMAN OTC DRUG Soleil Toujours Broad Spectrum SPF 50 Set Protect Micro Mist Avobenzone, Homosalate, Octisalate SPRAY TOPICAL 20160830 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE 25.17; 62.93; 41.95 mg/mL; mg/mL; mg/mL N 20181231 13630-0118_4831cddf-9490-6df8-e054-00144ff8d46c 13630-0118 HUMAN OTC DRUG Ulta Beauty SPF 15 Broad Spectrum Sunscreen Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20161229 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.2; 40.5; 15.73 mg/mL; mg/mL; mg/mL N 20181231 13630-0119_48ad466c-d899-3dd8-e054-00144ff8d46c 13630-0119 HUMAN OTC DRUG Ulta Beauty SPF 30 Broad Spectrum Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and, Oxybenzone SPRAY TOPICAL 20161230 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; HOMOSALATE 25.2; 42; 23.1; 16.8; 63 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0120_4a75ec4b-db7e-15ff-e054-00144ff8d46c 13630-0120 HUMAN OTC DRUG Ulta Beauty SPF 50 Broad Spectrum Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and, Oxybenzone SPRAY TOPICAL 20161230 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; HOMOSALATE 25.5; 42.5; 23.34; 34; 85 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0121_540f4b0c-2d15-1e0b-e054-00144ff88e88 13630-0121 HUMAN OTC DRUG Australian Gold Justice SPF 50 Glitter Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20170228 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.07; 86.9; 43.45; 23.9; 34.76 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13630-0122_56b760d4-f42a-64e8-e054-00144ff88e88 13630-0122 HUMAN OTC DRUG Florida Salt Scrubs Florida Grown Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20170731 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.34; 40.85; 15.11 mg/mL; mg/mL; mg/mL N 20181231 13630-0123_5acdd0b5-eba7-3edc-e053-2a91aa0a69d8 13630-0123 HUMAN OTC DRUG Florida Salt Scrubs Florida Snowbird Sunscreen 30 Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene SPRAY TOPICAL 20170814 OTC MONOGRAPH FINAL part352 Prime Packaging Inc. OCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE 22.61; 24.66; 41.1; 82.2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 13632-123_653917f0-f878-11e1-a21f-0800200c9a66 13632-123 HUMAN PRESCRIPTION DRUG Soltamox tamoxifen citrate LIQUID ORAL 20121001 NDA NDA021807 Rosemont Pharmaceuticals Ltd TAMOXIFEN CITRATE 10 mg/5mL Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 13668-001_75e262e6-6336-4e6a-b6e3-1fa41337628c 13668-001 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20070124 ANDA ANDA077711 Torrent Pharmaceuticals Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 13668-002_75e262e6-6336-4e6a-b6e3-1fa41337628c 13668-002 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20070124 ANDA ANDA077711 Torrent Pharmaceuticals Limited METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 13668-003_75e262e6-6336-4e6a-b6e3-1fa41337628c 13668-003 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20070124 ANDA ANDA077711 Torrent Pharmaceuticals Limited METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 13668-004_89622982-f40f-4553-8506-a8fd3d6cfde7 13668-004 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20070905 ANDA ANDA077765 Torrent Pharmaceuticals Limited SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-005_89622982-f40f-4553-8506-a8fd3d6cfde7 13668-005 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20070905 ANDA ANDA077765 Torrent Pharmaceuticals Limited SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-006_89622982-f40f-4553-8506-a8fd3d6cfde7 13668-006 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20070905 ANDA ANDA077765 Torrent Pharmaceuticals Limited SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-007_7642e1d6-a6bc-4538-8a89-ffbe053d957f 13668-007 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 TORRENT PHARMACEUTICALS LIMITED ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 13668-008_7642e1d6-a6bc-4538-8a89-ffbe053d957f 13668-008 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 TORRENT PHARMACEUTICALS LIMITED ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 13668-009_5788139d-650b-48df-a7dd-15a176506a04 13668-009 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Torrent Pharmaceuticals Limited CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 13668-010_5788139d-650b-48df-a7dd-15a176506a04 13668-010 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Torrent Pharmaceuticals Limited CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 13668-011_5788139d-650b-48df-a7dd-15a176506a04 13668-011 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Torrent Pharmaceuticals Limited CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 13668-012_03e39e4a-a01e-454c-af1f-d1e5ab30fea1 13668-012 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091230 ANDA ANDA090014 Torrent Pharmaceuticals Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 13668-013_03e39e4a-a01e-454c-af1f-d1e5ab30fea1 13668-013 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20100218 ANDA ANDA079226 Torrent Pharmaceuticals Limited METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 13668-014_5300faed-63d0-4119-b662-ff395483038e 13668-014 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078858 Torrent Pharmaceuticals Limited LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 13668-015_5300faed-63d0-4119-b662-ff395483038e 13668-015 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078858 Torrent Pharmaceuticals Limited LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 13668-016_5300faed-63d0-4119-b662-ff395483038e 13668-016 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078858 Torrent Pharmaceuticals Limited LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 13668-017_5300faed-63d0-4119-b662-ff395483038e 13668-017 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078858 Torrent Pharmaceuticals Limited LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 13668-018_8d7fcdfa-587c-40a5-85b9-597420157f19 13668-018 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110106 ANDA ANDA090899 Torrent Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-019_8d7fcdfa-587c-40a5-85b9-597420157f19 13668-019 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110106 ANDA ANDA090899 Torrent Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-020_8d7fcdfa-587c-40a5-85b9-597420157f19 13668-020 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110106 ANDA ANDA090899 Torrent Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-021_47fae4fa-d1f7-4076-90eb-9cdddc6ab8b3 13668-021 HUMAN PRESCRIPTION DRUG ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20110718 ANDA ANDA079054 Torrent Pharmaceuticals Limited ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 13668-022_c0fbe740-30ad-4422-98ad-7529ef878caf 13668-022 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20090205 ANDA ANDA078573 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 13668-023_c0fbe740-30ad-4422-98ad-7529ef878caf 13668-023 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20090205 ANDA ANDA078573 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 13668-024_c0fbe740-30ad-4422-98ad-7529ef878caf 13668-024 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20090205 ANDA ANDA078573 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 13668-029_6ed6ecbe-d11c-463b-81e5-e3da0073106e 13668-029 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20100415 ANDA ANDA079191 Torrent Pharmaceuticals Limited CETIRIZINE HYDROCHLORIDE 5 mg/1 E 20171231 13668-029_e1ce1874-89d5-499f-a042-99224346b87c 13668-029 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20100415 ANDA ANDA079191 Torrent Pharmaceuticals Limited CETIRIZINE HYDROCHLORIDE 5 mg/1 E 20171231 13668-030_881902c5-e6a8-4425-85c0-446b1ff9e0fd 13668-030 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20100415 ANDA ANDA079191 Torrent Pharmaceuticals Limited CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 13668-030_d3a0c14b-0204-40bc-ab0f-a58e0700850d 13668-030 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET ORAL 20100415 ANDA ANDA079191 Torrent Pharmaceuticals Limited CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 13668-031_e67cb5aa-8862-4a96-8c47-3aba09aecc55 13668-031 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 Torrent Pharmaceuticals Limited TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 13668-032_e67cb5aa-8862-4a96-8c47-3aba09aecc55 13668-032 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 Torrent Pharmaceuticals Limited TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 13668-033_e67cb5aa-8862-4a96-8c47-3aba09aecc55 13668-033 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 Torrent Pharmaceuticals Limited TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 13668-034_e67cb5aa-8862-4a96-8c47-3aba09aecc55 13668-034 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 Torrent Pharmaceuticals Limited TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 13668-035_f51ccf3e-ec46-4f7f-905d-51263f9f9fb6 13668-035 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Torrent Pharmaceuticals Limited RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-036_f51ccf3e-ec46-4f7f-905d-51263f9f9fb6 13668-036 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Torrent Pharmaceuticals Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-037_f51ccf3e-ec46-4f7f-905d-51263f9f9fb6 13668-037 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Torrent Pharmaceuticals Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-038_f51ccf3e-ec46-4f7f-905d-51263f9f9fb6 13668-038 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Torrent Pharmaceuticals Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-039_f51ccf3e-ec46-4f7f-905d-51263f9f9fb6 13668-039 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Torrent Pharmaceuticals Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-040_f51ccf3e-ec46-4f7f-905d-51263f9f9fb6 13668-040 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Torrent Pharmaceuticals Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-045_6873c2cf-2dd3-4e2d-8be3-9bb3b69e5022 13668-045 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 Torrent Pharmaceuticals Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 13668-047_6873c2cf-2dd3-4e2d-8be3-9bb3b69e5022 13668-047 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 Torrent Pharmaceuticals Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 13668-048_6873c2cf-2dd3-4e2d-8be3-9bb3b69e5022 13668-048 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 Torrent Pharmaceuticals Limited LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 13668-049_6873c2cf-2dd3-4e2d-8be3-9bb3b69e5022 13668-049 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 Torrent Pharmaceuticals Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 13668-067_498bdf34-c601-42fb-9cdc-8bfca419fd41 13668-067 HUMAN PRESCRIPTION DRUG valsartan valsartan TABLET ORAL 20150105 ANDA ANDA202728 Torrent Pharmaceuticals Limited VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-068_498bdf34-c601-42fb-9cdc-8bfca419fd41 13668-068 HUMAN PRESCRIPTION DRUG valsartan valsartan TABLET ORAL 20150105 ANDA ANDA202728 Torrent Pharmaceuticals Limited VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-069_498bdf34-c601-42fb-9cdc-8bfca419fd41 13668-069 HUMAN PRESCRIPTION DRUG valsartan valsartan TABLET ORAL 20150105 ANDA ANDA202728 Torrent Pharmaceuticals Limited VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-070_498bdf34-c601-42fb-9cdc-8bfca419fd41 13668-070 HUMAN PRESCRIPTION DRUG valsartan valsartan TABLET ORAL 20150105 ANDA ANDA202728 Torrent Pharmaceuticals Limited VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-079_18f88afc-a2c9-4304-a2e0-1e2caeb96222 13668-079 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA090984 Torrent Pharmaceuticals Limited MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 13668-080_18f88afc-a2c9-4304-a2e0-1e2caeb96222 13668-080 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA090984 Torrent Pharmaceuticals Limited MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 13668-081_18f88afc-a2c9-4304-a2e0-1e2caeb96222 13668-081 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20120803 ANDA ANDA201515 Torrent Pharmaceuticals Limited MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 13668-082_19ea3ba2-37ed-4f15-826a-5a6fe185ea6d 13668-082 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET ORAL 20110620 ANDA ANDA090722 Torrent Pharmaceuticals Limited LEVOFLOXACIN 250 mg/1 N 20181231 13668-083_19ea3ba2-37ed-4f15-826a-5a6fe185ea6d 13668-083 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET ORAL 20110620 ANDA ANDA090722 Torrent Pharmaceuticals Limited LEVOFLOXACIN 500 mg/1 N 20181231 13668-084_19ea3ba2-37ed-4f15-826a-5a6fe185ea6d 13668-084 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET ORAL 20110620 ANDA ANDA090722 Torrent Pharmaceuticals Limited LEVOFLOXACIN 750 mg/1 N 20181231 13668-086_28b9a73f-8144-49ed-8cad-ef67a7d23611 13668-086 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20111025 ANDA ANDA091415 TORRENT PHARMACEUTICALS LIMITED OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-088_28b9a73f-8144-49ed-8cad-ef67a7d23611 13668-088 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20111025 ANDA ANDA091415 TORRENT PHARMACEUTICALS LIMITED OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-089_28b9a73f-8144-49ed-8cad-ef67a7d23611 13668-089 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20111025 ANDA ANDA091415 TORRENT PHARMACEUTICALS LIMITED OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-090_28b9a73f-8144-49ed-8cad-ef67a7d23611 13668-090 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET, ORALLY DISINTEGRATING ORAL 20111025 ANDA ANDA091415 TORRENT PHARMACEUTICALS LIMITED OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-091_8f08425c-470b-497b-9f94-ea5dbee6b8df 13668-091 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Torrent Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 13668-092_8f08425c-470b-497b-9f94-ea5dbee6b8df 13668-092 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Torrent Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 13668-093_8f08425c-470b-497b-9f94-ea5dbee6b8df 13668-093 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Torrent Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 13668-094_8f08425c-470b-497b-9f94-ea5dbee6b8df 13668-094 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Torrent Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 13668-095_8f08425c-470b-497b-9f94-ea5dbee6b8df 13668-095 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Torrent Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 13668-096_1843d24f-2e80-4749-becc-9def6c3607c7 13668-096 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 Torrent Pharmaceuticals Limited PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 13668-102_94fb4253-7822-4043-8ef9-0f8d93642feb 13668-102 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Torrent Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 13668-103_94fb4253-7822-4043-8ef9-0f8d93642feb 13668-103 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Torrent Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 13668-104_c90b83a1-043c-40f1-895d-820f8e367381 13668-104 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200270 Torrent Pharmaceuticals Limited ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 13668-105_c90b83a1-043c-40f1-895d-820f8e367381 13668-105 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200495 Torrent Pharmaceuticals Limited ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 13668-106_c90b83a1-043c-40f1-895d-820f8e367381 13668-106 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200495 Torrent Pharmaceuticals Limited ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 13668-107_4d1e141f-24d6-41e0-a671-48ff69147297 13668-107 HUMAN PRESCRIPTION DRUG Rabeprazole sodium Rabeprazole sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA202376 Torrent Pharmaceuticals Limited RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 13668-109_5c9fc0c9-225c-4bce-bd0e-4d13be6fe0a8 13668-109 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Torrent Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 13668-110_5c9fc0c9-225c-4bce-bd0e-4d13be6fe0a8 13668-110 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Torrent Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 13668-111_5c9fc0c9-225c-4bce-bd0e-4d13be6fe0a8 13668-111 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Torrent Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 13668-113_92296151-e507-41b4-a040-c01b87ecb982 13668-113 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Torrent Pharmaceuticals Limited LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-115_92296151-e507-41b4-a040-c01b87ecb982 13668-115 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Torrent Pharmaceuticals Limited LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-116_d879633e-9968-44a2-bfc6-aa867a7fd83c 13668-116 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA090528 Torrent Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-117_d879633e-9968-44a2-bfc6-aa867a7fd83c 13668-117 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA090528 Torrent Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-118_d879633e-9968-44a2-bfc6-aa867a7fd83c 13668-118 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA090528 Torrent Pharmaceuticals Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-119_d2b87278-ffb3-418a-b99e-6a572ea3f0b6 13668-119 HUMAN PRESCRIPTION DRUG PIOGLITAZONEHYDROCHLORIDE PIOGLITAZONEHYDROCHLORIDE TABLET ORAL 20130213 ANDA ANDA091298 TORRENT PHARMACEUTICALS LIMITED PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 13668-120_d2b87278-ffb3-418a-b99e-6a572ea3f0b6 13668-120 HUMAN PRESCRIPTION DRUG PIOGLITAZONEHYDROCHLORIDE PIOGLITAZONEHYDROCHLORIDE TABLET ORAL 20130213 ANDA ANDA091298 TORRENT PHARMACEUTICALS LIMITED PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 13668-132_97983f2f-7a3c-4400-90ae-fe5fc7e09f0c 13668-132 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20111128 ANDA ANDA202170 Torrent Pharmaceuticals Limited FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 13668-133_97983f2f-7a3c-4400-90ae-fe5fc7e09f0c 13668-133 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20111128 ANDA ANDA202170 Torrent Pharmaceuticals Limited FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 13668-134_97983f2f-7a3c-4400-90ae-fe5fc7e09f0c 13668-134 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20111128 ANDA ANDA202170 Torrent Pharmaceuticals Limited FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 13668-135_31e1e1b4-0738-446c-8861-af5c49d08b54 13668-135 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 Torrent Pharmaceuticals Limited ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-136_31e1e1b4-0738-446c-8861-af5c49d08b54 13668-136 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 Torrent Pharmaceuticals Limited ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-137_31e1e1b4-0738-446c-8861-af5c49d08b54 13668-137 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 Torrent Pharmaceuticals Limited ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-140_d2b87278-ffb3-418a-b99e-6a572ea3f0b6 13668-140 HUMAN PRESCRIPTION DRUG PIOGLITAZONEHYDROCHLORIDE PIOGLITAZONEHYDROCHLORIDE TABLET ORAL 20130213 ANDA ANDA091298 TORRENT PHARMACEUTICALS LIMITED PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 13668-141_419e5cec-a6a4-4a37-b3ae-11c04f50556c 13668-141 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET ORAL 20120517 ANDA ANDA090844 Torrent Pharmaceuticals Limited CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 13668-148_150ea789-0a04-4019-9231-9863b8807085 13668-148 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET ORAL 20120327 ANDA ANDA200363 TORRENT PHARMACEUTICALS LIMITED QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-149_150ea789-0a04-4019-9231-9863b8807085 13668-149 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET ORAL 20120327 ANDA ANDA200363 TORRENT PHARMACEUTICALS LIMITED QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-150_150ea789-0a04-4019-9231-9863b8807085 13668-150 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET ORAL 20120327 ANDA ANDA200363 TORRENT PHARMACEUTICALS LIMITED QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-151_150ea789-0a04-4019-9231-9863b8807085 13668-151 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET ORAL 20120327 ANDA ANDA200363 TORRENT PHARMACEUTICALS LIMITED QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-152_150ea789-0a04-4019-9231-9863b8807085 13668-152 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET ORAL 20120327 ANDA ANDA200363 TORRENT PHARMACEUTICALS LIMITED QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-153_150ea789-0a04-4019-9231-9863b8807085 13668-153 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET ORAL 20120327 ANDA ANDA200363 TORRENT PHARMACEUTICALS LIMITED QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-154_20973b5f-8ee5-47e7-bbf6-4ab55db8dd7d 13668-154 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE ORAL 20151019 ANDA ANDA203636 Torrent Pharmaceuticals Limited ESOMEPRAZOLE MAGNESIUM 20 1/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 13668-155_20973b5f-8ee5-47e7-bbf6-4ab55db8dd7d 13668-155 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE ORAL 20151019 ANDA ANDA203636 Torrent Pharmaceuticals Limited ESOMEPRAZOLE MAGNESIUM 40 1/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 13668-156_35dbb934-56eb-4cc2-af29-4cc43d743b0b 13668-156 HUMAN PRESCRIPTION DRUG TELMISARTAN TELMISARTAN TABLET ORAL 20140707 ANDA ANDA203171 Torrent Pharmaceuticals Limited TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-157_35dbb934-56eb-4cc2-af29-4cc43d743b0b 13668-157 HUMAN PRESCRIPTION DRUG TELMISARTAN TELMISARTAN TABLET ORAL 20140707 ANDA ANDA203171 Torrent Pharmaceuticals Limited TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-158_35dbb934-56eb-4cc2-af29-4cc43d743b0b 13668-158 HUMAN PRESCRIPTION DRUG TELMISARTAN TELMISARTAN TABLET ORAL 20140707 ANDA ANDA203171 Torrent Pharmaceuticals Limited TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-159_d27eda8c-8f7a-49d5-82a1-92a1822c5b3b 13668-159 HUMAN PRESCRIPTION DRUG telmisartan and hydrochlorthiazide telmisartan and hydrochlorthiazide TABLET ORAL 20140225 ANDA ANDA201192 TORRENT PHARMACEUTICALS LIMITED TELMISARTAN; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-160_d27eda8c-8f7a-49d5-82a1-92a1822c5b3b 13668-160 HUMAN PRESCRIPTION DRUG telmisartan and hydrochlorthiazide telmisartan and hydrochlorthiazide TABLET ORAL 20140225 ANDA ANDA201192 TORRENT PHARMACEUTICALS LIMITED TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-161_d27eda8c-8f7a-49d5-82a1-92a1822c5b3b 13668-161 HUMAN PRESCRIPTION DRUG telmisartan and hydrochlorthiazide telmisartan and hydrochlorthiazide TABLET ORAL 20140225 ANDA ANDA201192 TORRENT PHARMACEUTICALS LIMITED TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-166_28b9a73f-8144-49ed-8cad-ef67a7d23611 13668-166 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 TORRENT PHARMACEUTICALS LIMITED OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-167_28b9a73f-8144-49ed-8cad-ef67a7d23611 13668-167 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 TORRENT PHARMACEUTICALS LIMITED OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-168_28b9a73f-8144-49ed-8cad-ef67a7d23611 13668-168 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 TORRENT PHARMACEUTICALS LIMITED OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-169_28b9a73f-8144-49ed-8cad-ef67a7d23611 13668-169 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 TORRENT PHARMACEUTICALS LIMITED OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-170_28b9a73f-8144-49ed-8cad-ef67a7d23611 13668-170 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 TORRENT PHARMACEUTICALS LIMITED OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-171_28b9a73f-8144-49ed-8cad-ef67a7d23611 13668-171 HUMAN PRESCRIPTION DRUG OLANZAPINE OLANZAPINE TABLET ORAL 20120423 ANDA ANDA091434 TORRENT PHARMACEUTICALS LIMITED OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-179_cce6c003-e803-4d29-ab95-e874539a7722 13668-179 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, COATED ORAL 20161031 ANDA ANDA201619 Torrent Pharmaceuticals Limited ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 13668-180_cce6c003-e803-4d29-ab95-e874539a7722 13668-180 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, COATED ORAL 20161031 ANDA ANDA201619 Torrent Pharmaceuticals Limited ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 13668-181_cce6c003-e803-4d29-ab95-e874539a7722 13668-181 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, COATED ORAL 20161031 ANDA ANDA201619 Torrent Pharmaceuticals Limited ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 13668-182_cce6c003-e803-4d29-ab95-e874539a7722 13668-182 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, COATED ORAL 20161031 ANDA ANDA201619 Torrent Pharmaceuticals Limited ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 13668-184_8f08425c-470b-497b-9f94-ea5dbee6b8df 13668-184 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Torrent Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 13668-185_55aa9711-6df5-4516-bf00-a1acf7f7a464 13668-185 HUMAN PRESCRIPTION DRUG SILDENAFIL CITRATE SILDENAFIL CITRATE TABLET ORAL 20121106 ANDA ANDA091479 Torrent Pharmaceuticals Limited SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 13668-189_f0077427-85f6-4e73-9dc1-499d54810ed1 13668-189 HUMAN PRESCRIPTION DRUG TOLTERODINE TARTRATE TOLTERODINE CAPSULE, EXTENDED RELEASE ORAL 20150811 ANDA ANDA203016 Torrent Pharmaceuticals Limited TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 13668-190_f0077427-85f6-4e73-9dc1-499d54810ed1 13668-190 HUMAN PRESCRIPTION DRUG TOLTERODINE TARTRATE TOLTERODINE CAPSULE, EXTENDED RELEASE ORAL 20150811 ANDA ANDA203016 Torrent Pharmaceuticals Limited TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 13668-201_a4bf2778-30ca-4294-8f98-fcfd69bdbec2 13668-201 HUMAN PRESCRIPTION DRUG moxifloxacin hydrochloride moxifloxacin hydrochloride TABLET ORAL 20140403 ANDA ANDA200160 TORRENT PHARMACEUTICALS LIMITED MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 13668-202_a13c57b2-8aa5-4263-bbdd-c2ea7b67c417 13668-202 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin TABLET, EXTENDED RELEASE ORAL 20161118 ANDA ANDA205209 Torrent Pharmaceuticals Limited DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 13668-203_a13c57b2-8aa5-4263-bbdd-c2ea7b67c417 13668-203 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin TABLET, EXTENDED RELEASE ORAL 20161118 ANDA ANDA205209 Torrent Pharmaceuticals Limited DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 13668-204_281a04e7-dc71-4417-9dcc-8418193866c5 13668-204 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA202377 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-205_281a04e7-dc71-4417-9dcc-8418193866c5 13668-205 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA202377 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-206_281a04e7-dc71-4417-9dcc-8418193866c5 13668-206 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA202377 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-207_281a04e7-dc71-4417-9dcc-8418193866c5 13668-207 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA202377 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-216_1db872f5-b998-4385-9070-7a85d129c16f 13668-216 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 TORRENT PHARMACEUTICALS LIMITED ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-217_1db872f5-b998-4385-9070-7a85d129c16f 13668-217 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 TORRENT PHARMACEUTICALS LIMITED ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-218_1db872f5-b998-4385-9070-7a85d129c16f 13668-218 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 TORRENT PHARMACEUTICALS LIMITED ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-219_1db872f5-b998-4385-9070-7a85d129c16f 13668-219 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 TORRENT PHARMACEUTICALS LIMITED ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-220_1db872f5-b998-4385-9070-7a85d129c16f 13668-220 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 TORRENT PHARMACEUTICALS LIMITED ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-221_1db872f5-b998-4385-9070-7a85d129c16f 13668-221 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 TORRENT PHARMACEUTICALS LIMITED ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 13668-222_ba59daaa-a0ce-471f-830d-2e3eb9ff04e3 13668-222 HUMAN PRESCRIPTION DRUG Memantine hydrochloride Memantine hydrochloride TABLET ORAL 20151013 ANDA ANDA200155 Torrent Pharmaceuticals Limited MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 13668-223_ba59daaa-a0ce-471f-830d-2e3eb9ff04e3 13668-223 HUMAN PRESCRIPTION DRUG Memantine hydrochloride Memantine hydrochloride TABLET ORAL 20151013 ANDA ANDA200155 Torrent Pharmaceuticals Limited MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 13668-248_d01b3af0-69eb-48fb-9062-a9bc3191273d 13668-248 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET ORAL 20170424 ANDA ANDA202375 TORRENT PHARMACEUTICALS LIMITED OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-249_d01b3af0-69eb-48fb-9062-a9bc3191273d 13668-249 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET ORAL 20170424 ANDA ANDA202375 TORRENT PHARMACEUTICALS LIMITED OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-250_d01b3af0-69eb-48fb-9062-a9bc3191273d 13668-250 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET ORAL 20170424 ANDA ANDA202375 TORRENT PHARMACEUTICALS LIMITED OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-251_541fb57c-f4d8-4980-9994-86fe7ccec177 13668-251 HUMAN PRESCRIPTION DRUG OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 TABLET ORAL 20170424 ANDA ANDA206515 TORRENT PHARMACEUTICALS LIMITED OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-252_541fb57c-f4d8-4980-9994-86fe7ccec177 13668-252 HUMAN PRESCRIPTION DRUG OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/12.5 TABLET ORAL 20170424 ANDA ANDA206515 TORRENT PHARMACEUTICALS LIMITED OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-253_541fb57c-f4d8-4980-9994-86fe7ccec177 13668-253 HUMAN PRESCRIPTION DRUG OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/25 TABLET ORAL 20170424 ANDA ANDA206515 TORRENT PHARMACEUTICALS LIMITED OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-266_6873c2cf-2dd3-4e2d-8be3-9bb3b69e5022 13668-266 HUMAN PRESCRIPTION DRUG LAMOTRIGINE lamotrigine KIT 20090914 ANDA ANDA078947 Torrent Pharmaceuticals Limited N 20181231 13668-268_768c81ff-a569-4b29-9224-76b128f411a2 13668-268 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20091023 ANDA ANDA077272 Torrent Pharmaceuticals Limited CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 13668-271_768c81ff-a569-4b29-9224-76b128f411a2 13668-271 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET, CHEWABLE ORAL 20090826 ANDA ANDA075712 Torrent Pharmaceuticals Limited CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 13668-272_b7c20cee-55ea-495e-8a4d-1f9e4b20c58f 13668-272 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE ORAL 20120529 ANDA ANDA091338 Torrent Pharmaceuticals Limited LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 13668-280_9bccfabb-b440-4c75-aa6e-e4c62705439d 13668-280 HUMAN PRESCRIPTION DRUG Pioglitazone HCL and Metformin HCL Pioglitazone HCL and Metformin HCL TABLET ORAL 20130213 ANDA ANDA202001 TORRENT PHARMACEUTICALS LIMITED METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500; 15 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 13668-281_9bccfabb-b440-4c75-aa6e-e4c62705439d 13668-281 HUMAN PRESCRIPTION DRUG Pioglitazone HCL and Metformin HCL Pioglitazone HCL and Metformin HCL TABLET ORAL 20130213 ANDA ANDA202001 TORRENT PHARMACEUTICALS LIMITED METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850; 15 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 13668-290_cff3806e-48f1-494c-85ab-b37f405840bc 13668-290 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE ORAL 20141031 ANDA ANDA203240 Torrent Pharmaceuticals Limited FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-291_cff3806e-48f1-494c-85ab-b37f405840bc 13668-291 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate CAPSULE, EXTENDED RELEASE ORAL 20141031 ANDA ANDA203240 Torrent Pharmaceuticals Limited FLUVOXAMINE MALEATE 150 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-300_b7c20cee-55ea-495e-8a4d-1f9e4b20c58f 13668-300 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, EXTENDED RELEASE ORAL 20120529 ANDA ANDA091338 Torrent Pharmaceuticals Limited LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 13668-307_157db1c9-1844-4fad-b88c-491dac492884 13668-307 HUMAN PRESCRIPTION DRUG celecoxib celecoxib CAPSULE ORAL 20151223 ANDA ANDA207677 Torrent Pharmaceuticals Limited CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 13668-310_157db1c9-1844-4fad-b88c-491dac492884 13668-310 HUMAN PRESCRIPTION DRUG celecoxib celecoxib CAPSULE ORAL 20151223 ANDA ANDA207677 Torrent Pharmaceuticals Limited CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 13668-311_1bca9c1e-38e8-4119-ad73-3acf95025128 13668-311 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET ORAL 20161125 ANDA ANDA202933 TORRENT PHARMACEUTICALS LIMITED AMLODIPINE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-312_1bca9c1e-38e8-4119-ad73-3acf95025128 13668-312 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET ORAL 20161125 ANDA ANDA202933 TORRENT PHARMACEUTICALS LIMITED AMLODIPINE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-313_1bca9c1e-38e8-4119-ad73-3acf95025128 13668-313 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET ORAL 20161125 ANDA ANDA202933 TORRENT PHARMACEUTICALS LIMITED AMLODIPINE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-324_1bca9c1e-38e8-4119-ad73-3acf95025128 13668-324 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET ORAL 20161125 ANDA ANDA202933 TORRENT PHARMACEUTICALS LIMITED AMLODIPINE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-325_ae1221ac-8ded-489a-8921-6f8549fefbcc 13668-325 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET ORAL 20150603 ANDA ANDA201593 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 320; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-326_ae1221ac-8ded-489a-8921-6f8549fefbcc 13668-326 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET ORAL 20150603 ANDA ANDA201593 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-327_ae1221ac-8ded-489a-8921-6f8549fefbcc 13668-327 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET ORAL 20150603 ANDA ANDA201593 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-328_ae1221ac-8ded-489a-8921-6f8549fefbcc 13668-328 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET ORAL 20150603 ANDA ANDA201593 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-329_ae1221ac-8ded-489a-8921-6f8549fefbcc 13668-329 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET ORAL 20150603 ANDA ANDA201593 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-330_1e27a4d6-e797-4c7d-9666-e81552fd42fa 13668-330 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20131127 ANDA ANDA202180 Torrent Pharmaceuticals Limited TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 13668-331_1e27a4d6-e797-4c7d-9666-e81552fd42fa 13668-331 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20131127 ANDA ANDA202180 Torrent Pharmaceuticals Limited TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 13668-332_1e27a4d6-e797-4c7d-9666-e81552fd42fa 13668-332 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20131127 ANDA ANDA202180 Torrent Pharmaceuticals Limited TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 13668-333_1e27a4d6-e797-4c7d-9666-e81552fd42fa 13668-333 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20131127 ANDA ANDA202180 Torrent Pharmaceuticals Limited TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 13668-339_19e9c244-3354-44d9-bbf9-6b54b255d89f 13668-339 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20131223 ANDA ANDA203370 Torrent Pharmaceuticals Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 13668-340_19e9c244-3354-44d9-bbf9-6b54b255d89f 13668-340 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20131223 ANDA ANDA203370 Torrent Pharmaceuticals Limited LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 13668-341_19e9c244-3354-44d9-bbf9-6b54b255d89f 13668-341 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20131223 ANDA ANDA203370 Torrent Pharmaceuticals Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 13668-342_19e9c244-3354-44d9-bbf9-6b54b255d89f 13668-342 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20131223 ANDA ANDA203370 Torrent Pharmaceuticals Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 13668-343_660cc055-4d9f-4f32-98c5-708480d6b637 13668-343 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA202517 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; TELMISARTAN 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-344_660cc055-4d9f-4f32-98c5-708480d6b637 13668-344 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA202517 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; TELMISARTAN 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-345_660cc055-4d9f-4f32-98c5-708480d6b637 13668-345 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA202517 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; TELMISARTAN 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-346_660cc055-4d9f-4f32-98c5-708480d6b637 13668-346 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA202517 Torrent Pharmaceuticals Limited AMLODIPINE BESYLATE; TELMISARTAN 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-382_7b2f628e-b066-47f3-b5da-d6987ef76a29 13668-382 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/25 mg Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/10/25 mg TABLET ORAL 20161026 ANDA ANDA203580 TORRENT PHARMACEUTICALS LIMITED OLMESARTAN MEDOXOMIL; AMLODIPINE; HYDROCHLOROTHIAZIDE 40; 10; 25 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-383_7b2f628e-b066-47f3-b5da-d6987ef76a29 13668-383 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/10/12.5 mg TABLET ORAL 20161026 ANDA ANDA203580 TORRENT PHARMACEUTICALS LIMITED OLMESARTAN MEDOXOMIL; AMLODIPINE; HYDROCHLOROTHIAZIDE 40; 10; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-385_7b2f628e-b066-47f3-b5da-d6987ef76a29 13668-385 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg TABLET ORAL 20161026 ANDA ANDA203580 TORRENT PHARMACEUTICALS LIMITED OLMESARTAN MEDOXOMIL; AMLODIPINE; HYDROCHLOROTHIAZIDE 40; 5; 25 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-386_7b2f628e-b066-47f3-b5da-d6987ef76a29 13668-386 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/12.5 mg Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/12.5 mg TABLET ORAL 20161026 ANDA ANDA203580 TORRENT PHARMACEUTICALS LIMITED OLMESARTAN MEDOXOMIL; AMLODIPINE; HYDROCHLOROTHIAZIDE 40; 5; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-397_7b2f628e-b066-47f3-b5da-d6987ef76a29 13668-397 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 20/5/12.5 mg Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 20/5/12.5 mg TABLET ORAL 20161026 ANDA ANDA203580 TORRENT PHARMACEUTICALS LIMITED OLMESARTAN MEDOXOMIL; AMLODIPINE; HYDROCHLOROTHIAZIDE 20; 5; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13668-409_92296151-e507-41b4-a040-c01b87ecb982 13668-409 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Torrent Pharmaceuticals Limited LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 13668-429_1843d24f-2e80-4749-becc-9def6c3607c7 13668-429 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 Torrent Pharmaceuticals Limited PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 13668-430_64072372-9900-47b2-a46a-ba216a06cad3 13668-430 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20141031 ANDA ANDA203969 Torrent Pharmaceuticals Limited BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 13668-431_64072372-9900-47b2-a46a-ba216a06cad3 13668-431 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20141031 ANDA ANDA203969 Torrent Pharmaceuticals Limited BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 13668-432_64072372-9900-47b2-a46a-ba216a06cad3 13668-432 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20141031 ANDA ANDA203969 Torrent Pharmaceuticals Limited BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 13668-441_157db1c9-1844-4fad-b88c-491dac492884 13668-441 HUMAN PRESCRIPTION DRUG celecoxib celecoxib CAPSULE ORAL 20151223 ANDA ANDA207677 Torrent Pharmaceuticals Limited CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 13668-442_157db1c9-1844-4fad-b88c-491dac492884 13668-442 HUMAN PRESCRIPTION DRUG celecoxib celecoxib CAPSULE ORAL 20151223 ANDA ANDA207677 Torrent Pharmaceuticals Limited CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 13668-443_cea21cfb-ae0b-47ce-ba8f-9b4ec2b55280 13668-443 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine TABLET ORAL 20161021 ANDA ANDA206937 TORRENT PHARMACEUTICALS LIMITED FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-453_da9106e7-80de-4af7-8d38-c1ac79b6c1ee 13668-453 HUMAN PRESCRIPTION DRUG anagrelide anagrelide CAPSULE ORAL 20170630 ANDA ANDA209151 Torrent Pharmaceuticals Limited ANAGRELIDE HYDROCHLORIDE .5 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 13668-462_da9106e7-80de-4af7-8d38-c1ac79b6c1ee 13668-462 HUMAN PRESCRIPTION DRUG anagrelide anagrelide CAPSULE ORAL 20170630 ANDA ANDA209151 Torrent Pharmaceuticals Limited ANAGRELIDE HYDROCHLORIDE 1 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 13668-473_cea21cfb-ae0b-47ce-ba8f-9b4ec2b55280 13668-473 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine TABLET ORAL 20161021 ANDA ANDA206937 TORRENT PHARMACEUTICALS LIMITED FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13668-482_e08d028b-ffce-49c7-87ea-699186ff3dd8 13668-482 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20150402 ANDA ANDA065062 Torrent Pharmaceuticals Limited MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 13668-483_e08d028b-ffce-49c7-87ea-699186ff3dd8 13668-483 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20150402 ANDA ANDA065062 Torrent Pharmaceuticals Limited MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 13668-484_e08d028b-ffce-49c7-87ea-699186ff3dd8 13668-484 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20150402 ANDA ANDA065062 Torrent Pharmaceuticals Limited MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 13668-485_9b0834df-2c21-4fd9-a3c0-31436fbd8627 13668-485 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET ORAL 20150402 ANDA ANDA065156 Torrent Pharmaceuticals Limited MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 13668-486_9b0834df-2c21-4fd9-a3c0-31436fbd8627 13668-486 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET ORAL 20150402 ANDA ANDA065156 Torrent Pharmaceuticals Limited MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 13668-487_9b0834df-2c21-4fd9-a3c0-31436fbd8627 13668-487 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET ORAL 20150402 ANDA ANDA065156 Torrent Pharmaceuticals Limited MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 13709-230_4c8ccbcb-a74e-414f-aba2-d89cb28776ca 13709-230 HUMAN OTC DRUG ClearCanal NeilMed Ear Wax Removal Complete Kit SOLUTION/ DROPS AURICULAR (OTIC) 20110824 OTC MONOGRAPH FINAL part344 NeilMed Pharmaceuticals, Inc. CARBAMIDE PEROXIDE 65 mg/mL E 20171231 13709-231_23e7762d-8b65-6578-e054-00144ff88e88 13709-231 HUMAN OTC DRUG SinuFrin NeilMed Oxymetazoline Hydrochloride SPRAY NASAL 20120715 OTC MONOGRAPH FINAL part341 NeilMed Pharmaceuticals Inc OXYMETAZOLINE HYDROCHLORIDE 7.5 mg/15mL CII E 20171231 13709-232_23e7762d-8b80-6578-e054-00144ff88e88 13709-232 HUMAN OTC DRUG SinuFrin Plus NeilMed Oxymetazoline Hydrochloride SPRAY NASAL 20120715 OTC MONOGRAPH FINAL part341 NeilMed Pharmaceuticals, Inc. OXYMETAZOLINE HYDROCHLORIDE 7.5 mg/15mL CII E 20171231 13709-235_55a1fc63-2528-4033-e054-00144ff8d46c 13709-235 HUMAN OTC DRUG Wound Wash Antiseptic Saline with Benzalkonium Chloride Wound Wash Antiseptic Saline with Benzalkonium Chloride AEROSOL, SPRAY TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part333A NeilMed Pharmaceuticals, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 13709-281_206a1894-676f-442a-ad54-f78c5c0d8ab6 13709-281 HUMAN OTC DRUG Sinu Inhaler Levmetamfetamine Nasal Decongestant INHALANT NASAL 20140615 OTC MONOGRAPH FINAL part341 NeilMed LEVMETAMFETAMINE 50 mg/1 E 20171231 13710-235_413387c2-15c3-254c-e054-00144ff8d46c 13710-235 HUMAN OTC DRUG Neil cleanse Wound Wash Antiseptic Sterile Saline with Benzalkonium chloride NeilMed Wound Wash Antiseptic Sterile Saline with Benzalkonium chloride AEROSOL, SPRAY TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part333A NeilMed Pharmaceuticals, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 13733-001_2fdd6eb6-eac2-421f-bb89-3915ac84f052 13733-001 HUMAN OTC DRUG MISSHA M WATERY B.B SPF 27 TITANIUM DIOXIDE CREAM CUTANEOUS 20080416 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE 3.57 mL/50mL E 20171231 13733-002_96d871b4-45b8-4e8f-be43-ad3daf881f85 13733-002 HUMAN OTC DRUG MISSHA M PERFECT COVER BB SPF42 ZINC OXIDE CREAM CUTANEOUS 20071024 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. ZINC OXIDE 3.5 mL/50mL E 20171231 13733-003_0f1f9ab4-b703-4dd9-9e36-a0c7dbfc3b9f 13733-003 HUMAN OTC DRUG MISSHA M SHINY BB SPF27 TITANIUM DIOXIDE CREAM CUTANEOUS 20080416 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE 3.77 mL/50mL E 20171231 13733-004_3dfb44a5-ba5c-4d90-a48b-05b3bf5bb92a 13733-004 HUMAN OTC DRUG MISSHA M SIGNATURE RADIANCE FOUNDATION SPF20 TITANIUM DIOXIDE CREAM CUTANEOUS 20090219 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE 3.25 mL/35mL E 20171231 13733-005_d0468086-4f2b-4808-9ae2-3f2cdb72c049 13733-005 HUMAN OTC DRUG MISSHA M SIGNATURE RADIANCE TWO WAY PACT SPF27 TITANIUM DIOXIDE POWDER CUTANEOUS 20090210 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE .98 g/11g E 20171231 13733-006_649dd1c6-0300-4fcb-829a-430e9551b6bc 13733-006 HUMAN OTC DRUG MISSHA M VITA BB SPF20 TITANIUM DIOXIDE CREAM CUTANEOUS 20070502 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE 3.5 mL/50mL E 20171231 13733-010_17b5837d-7f6e-45be-a303-88a400155da6 13733-010 HUMAN OTC DRUG MISSHA M SIGNATURE REAL COMPLETE BB SPF25 PA PLUS PLUS TITANIUM DIOXIDE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 3.24; 1.71 g/45g; g/45g E 20171231 13733-011_61f0aebb-6289-490a-9819-45a1b436e819 13733-011 HUMAN OTC DRUG MISA CHO BO YANG BB SPF30 PA PLUS PLUS NO.1 NATURAL BEIGE TITANIUM DIOXIDE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 5.2; .7 mL/50mL; mL/50mL E 20171231 13733-012_1178386a-35f8-4607-99d9-1dd14ae361c7 13733-012 HUMAN OTC DRUG MISSHA M SWIRL BB SUN BALM SPF50 PLUS PA PLUS PLUS PLUS NO.21 TITANIUM DIOXIDE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 4.46; 1.44 g/20g; g/20g E 20171231 13733-013_ec72eb63-1942-41c8-b8ea-f95b474d51c1 13733-013 HUMAN OTC DRUG MISSHA SIGNATURE WRINKLE FILLER BB SPF37 PA PLUS PLUS NO.23 TITANIUM DIOXIDE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.268; 2.2; 1.276 g/44g; g/44g; g/44g E 20171231 13733-014_8b72633e-c1cd-4722-8c81-f82807e9605c 13733-014 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN SPF45 PA PLUS PLUS PLUS OCTINOXATE CREAM CUTANEOUS 20110601 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; OCTISALATE; ENSULIZOLE 3.5; 2.4; 2 mL/50mL; mL/50mL; mL/50mL E 20171231 13733-015_7074f5d0-8e94-4d19-9f9c-edac53dfa435 13733-015 HUMAN OTC DRUG MISSHA SIGNATURE DRAMATIC WHITENING PACT NO.2 SPF50 PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120301 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.84; .66; .32 g/11g; g/11g; g/11g E 20171231 13733-016_f2544331-3b7b-4777-9680-c6a8218dc300 13733-016 HUMAN OTC DRUG MISSHA GLAM SILKY BODY BALM SPF 27 Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.88; 1.5; .48 g/25g; g/25g; g/25g E 20171231 13733-017_7d4f3728-9ac2-4b6c-9d24-5f22bb430dc9 13733-017 HUMAN OTC DRUG MISSHA M PRISM BRIGHT ON AUTO NO.2 SPF35 PA PLUS PLUS PLUS Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20120301 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .81; .57; .28 g/9.5g; g/9.5g; g/9.5g E 20171231 13733-018_91c50152-9f70-4b21-9ea2-ea30e3ed365e 13733-018 HUMAN OTC DRUG MISSHA SIGNATURE EXTREME COVER CONCEALER NO.23 SPF30 PA PLUS PLUS Titanium Dioxide CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE 2.28 g/10g E 20171231 13733-019_9246f162-13b9-430b-b416-dbf8fa8b87af 13733-019 HUMAN OTC DRUG MISSHA TIME REVOLUTION WHITE CURE UV SUN PROTECTOR SPF50 PLUS PA PLUS PLUS PLUS ZINC OXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 ABLE C&C CO., LTD. ZINC OXIDE; OCTINOXATE; OCTISALATE 3.89; 2.66; .76 g/38g; g/38g; g/38g E 20171231 13733-020_78e09168-48fd-4705-a55c-82d0dea65820 13733-020 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN BROAD SPECTRUM SPF45 OCTINOXATE, OCTISALATE, ENSULIZOLE CREAM TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; OCTISALATE; ENSULIZOLE 3.5; 2.4; 2 mg/50mL; mg/50mL; mg/50mL E 20171231 13733-030_d1d93232-f790-494f-bd75-aaa7f3ceb1c9 13733-030 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK SOFT FINISH SUN MILK BROAD SPECTRUM SPF 50 PLUS OCTINOXATE, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 3; 2.76; .87 mg/40mL; mg/40mL; mg/40mL E 20171231 13733-033_53207f90-e639-3bc4-e054-00144ff8d46c 13733-033 HUMAN OTC DRUG MISSHA M SHINY BB TITANIUM DIOXIDE CREAM CUTANEOUS 20080416 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE 7.5 mg/g N 20181231 13733-040_4f208724-a498-5996-e054-00144ff8d46c 13733-040 HUMAN OTC DRUG MISSHA SIGNATURE COMPLEXION COORDINATING BB BEIGE BROAD SPECTRUM SPF43 Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.96; 3.5; 3.5 mg/50mL; mg/50mL; mg/50mL N 20181231 13733-044_532093d0-9ad2-476d-e054-00144ff8d46c 13733-044 HUMAN OTC DRUG MISSHA M SIGNATURE RADIANCE FOUNDATION TITANIUM DIOXIDE CREAM CUTANEOUS 20090219 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE 9.3 mg/g N 20181231 13733-050_749aa7de-1c90-4ecb-b747-1938f79ad8f8 13733-050 HUMAN OTC DRUG MISSHA SIGNATURE COMPLEXION COORDINATING BB WHITE BROAD SPECTRUM SPF43 Titanium Dioxide, OCTINOXATE, OCTISALATE, Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 4.05; 3.75; 2.5; 2.45 mg/50mL; mg/50mL; mg/50mL; mg/50mL E 20171231 13733-060_4f208724-a4a2-5996-e054-00144ff8d46c 13733-060 HUMAN OTC DRUG MISSHA TIME REVOLUTION WHITE CURE BLANC SUN PROTECTOR NW BROAD SPECTRUM SPF50 PLUS ZINC OXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. ZINC OXIDE; OCTINOXATE; OCTISALATE 3.75; 3.5; 1 g/50g; g/50g; g/50g N 20181231 13733-070_0d5bce0e-8022-4622-a5ad-58cd43f42fcc 13733-070 HUMAN OTC DRUG MISSHA SIGNATURE COMPLEXION COORDINATING BB HONEY BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.55; 1.4; 1.4 mg/20mL; mg/20mL; mg/20mL E 20171231 13733-080_f799c721-ed8a-4188-8102-a4c73973a353 13733-080 HUMAN OTC DRUG MISSHA M SIGNATURE REAL COMPLETE BB Honey Beige Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 ABLE C&C Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.47; 1.73 g/45g; g/45g E 20171231 13733-090_4f0879d0-44cb-59fd-e054-00144ff8d46c 13733-090 HUMAN OTC DRUG MISSHA M Magic Cushion No.21 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 ABLE C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 2; 1; .6 g/15g; g/15g; g/15g N 20181231 13733-100_4f0cb1cb-0e13-2610-e054-00144ff88e88 13733-100 HUMAN OTC DRUG MISSHA M Magic Cushion No.23 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 ABLE C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 2; 1; .6 g/15g; g/15g; g/15g N 20181231 13733-110_4f05981c-4726-33af-e054-00144ff88e88 13733-110 HUMAN OTC DRUG MISSHA Signature Essence Cushion No 21 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.24; .93; .56 g/14g; g/14g; g/14g N 20181231 13733-120_4f0cf9e1-6b6a-39db-e054-00144ff88e88 13733-120 HUMAN OTC DRUG MISSHA Signature Essence Cushion No 23 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.24; .93; .56 g/14g; g/14g; g/14g N 20181231 13733-130_4f0cf9e1-6b58-39db-e054-00144ff88e88 13733-130 HUMAN OTC DRUG MISSHA M Magic Cushion No 27 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.69; 1; .6 g/15g; g/15g; g/15g N 20181231 13733-140_4f0696ea-6626-563a-e054-00144ff88e88 13733-140 HUMAN OTC DRUG MISSHA M Perfect Cover BB No 13 Zinc Oxide, Titanium Dioxide, Octinoxate CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE 3.5; 2.09; 3.75 g/50mL; g/50mL; g/50mL N 20181231 13733-150_4f06e890-9699-0c5a-e054-00144ff8d46c 13733-150 HUMAN OTC DRUG MISSHA M Perfect Cover BB No 21 Zinc Oxide, Titanium Dioxide, Octinoxate CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE 3.5; 2.09; 3.75 g/50mL; g/50mL; g/50mL N 20181231 13733-160_4f072bb7-d5df-68b3-e054-00144ff88e88 13733-160 HUMAN OTC DRUG MISSHA M Perfect Cover BB No 23 Zinc Oxide, Titanium Dioxide, Octinoxate CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE 3.5; 2.09; 3.75 g/50mL; g/50mL; g/50mL N 20181231 13733-165_604e7a49-7987-11ee-e053-2a91aa0a1bee 13733-165 HUMAN OTC DRUG MISSHA M Perfect Cover BB Cream SPF42 (No. 25) Zinc Oxide, Titanium Dioxide, Octinoxate CREAM TOPICAL 20171214 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 2.099; 3.5; 3.75 g/50mL; g/50mL; g/50mL N 20181231 13733-170_4f07e3c7-49ce-1770-e054-00144ff88e88 13733-170 HUMAN OTC DRUG MISSHA M Perfect Cover BB No 27 Zinc Oxide, Titanium Dioxide, Octinoxate CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE 3.5; 2.09; 3.75 g/50mL; g/50mL; g/50mL N 20181231 13733-180_539a3e32-f0df-1bbb-e054-00144ff88e88 13733-180 HUMAN OTC DRUG MISSHA M Perfect Cover BB No 31 Zinc Oxide, Titanium Dioxide, Octinoxate CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE 3.5; 2.09; 3.75 g/50mL; g/50mL; g/50mL N 20181231 13733-190_57459225-d898-6e6b-e053-2991aa0afbb1 13733-190 HUMAN OTC DRUG MISSHA M MAGIC CUSHION MOISTURE NO21 Titanium Dioxide,Octinoxate,Octisalate, CREAM TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.4775; 1.005; .6 g/15g; g/15g; g/15g N 20181231 13733-191_57459225-d8a6-6e6b-e053-2991aa0afbb1 13733-191 HUMAN OTC DRUG MISSHA M Magic Cushion Moisture No23 Titanium Dioxide, Octinoxate, Octisalate CREAM TOPICAL 20160622 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.4775; 1.005; .6 g/15g; g/15g; g/15g N 20181231 13733-192_52937d86-54a4-6e8a-e054-00144ff88e88 13733-192 HUMAN OTC DRUG MISSHA M MAGIC CUSHION COVER NO21 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 ABLE C&C Co., Ltd. TITANIUM DIOXIDE; OCTISALATE; OCTINOXATE 2; .6; 1 g/15g; g/15g; g/15g N 20181231 13733-193_5293abc5-8199-52ea-e054-00144ff8d46c 13733-193 HUMAN OTC DRUG MISSHA M MAGIC CUSHION COVER SPF 50 NO 23 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 ABLE C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 2; 1; .6 g/15g; g/15g; g/15g N 20181231 13733-194_4db4b5ed-2285-3cf9-e054-00144ff8d46c 13733-194 HUMAN OTC DRUG MISSHA SIGNATURE ESSENCE CUSHION INTENSIVE COVER SPF50 NO 21 Titanium Dioxide, Octinoxate, Octisalate CREAM TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.7921; .938; .56 g/14g; g/14g; g/14g N 20181231 13733-195_4db4b5ed-2285-3cf9-e054-00144ff8d46c 13733-195 HUMAN OTC DRUG MISSHA SIGNATURE ESSENCE CUSHION INTENSIVE COVER SPF50 NO 23 Titanium Dioxide, Octinoxate, Octisalate CREAM TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.7921; .938; .56 g/14g; g/14g; g/14g N 20181231 13733-196_4db3ed71-20d4-167e-e054-00144ff8d46c 13733-196 HUMAN OTC DRUG MISSHA SIGNATURE WRINKLE FILL UP BB NO 21 Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.2636; 2.2; 1.2936 g/44g; g/44g; g/44g N 20181231 13733-197_4db3ed71-20d4-167e-e054-00144ff8d46c 13733-197 HUMAN OTC DRUG MISSHA SIGNATURE WRINKLE FILL UP BB NO 23 Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.2636; 2.2; 1.2936 g/44g; g/44g; g/44g N 20181231 13733-201_50253727-5f21-03bd-e054-00144ff88e88 13733-201 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK WATERPROOF SUN MILK SPF50 70ML Titanium Dioxide, OCTINOXATE, Zinc Oxide LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE 4.83; 1.5305; 5.25 g/70g; g/70g; g/70g N 20181231 13733-202_50253727-5f21-03bd-e054-00144ff88e88 13733-202 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK WATERPROOF SUN MILK SPF50 40ML Titanium Dioxide, OCTINOXATE, Zinc Oxide LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3; .8746; 2.76 g/40g; g/40g; g/40g N 20181231 13733-203_50254424-628b-0489-e054-00144ff88e88 13733-203 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK SOFT FINISH SUN MILK 70ML Zinc Oxide, Octinoxate, Octisalate, Titanium Dioxide LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTISALATE; OCTINOXATE; ZINC OXIDE 1.743; 2.1; 2.1; 3.696 g/70g; g/70g; g/70g; g/70g N 20181231 13733-204_50254424-628b-0489-e054-00144ff88e88 13733-204 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK SOFT FINISH SUN MILK 40ML Zinc Oxide, Octinoxate, Octisalate, Titanium Dioxide LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTISALATE; TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.2; .996; 1.2; 2.112 g/40g; g/40g; g/40g; g/40g N 20181231 13733-205_50254c9d-1a67-078d-e054-00144ff88e88 13733-205 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK 70ML Octinoxate, Octocrylene, Octisalate, Avobenzone LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 4.9; 3.5; 3.15; 2.1 g/70g; g/70g; g/70g; g/70g N 20181231 13733-206_50254c9d-1a67-078d-e054-00144ff88e88 13733-206 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK 40ML Octinoxate, Octocrylene, Octisalate, Avobenzone LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 2.8; 2; 1.8; 1.2 g/40g; g/40g; g/40g; g/40g N 20181231 13733-207_4db3ed71-20a9-167e-e054-00144ff8d46c 13733-207 HUMAN OTC DRUG MISSHA CLOSING COVER CONCEALER SPF30 NO21 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 20.24; 1.44 mg/g; mg/g N 20181231 13733-208_4db3ed71-20a9-167e-e054-00144ff8d46c 13733-208 HUMAN OTC DRUG MISSHA CLOSING COVER CONCEALER SPF30 NO23 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 20.24; 1.44 mg/g; mg/g N 20181231 13733-211_4db388ef-6629-6703-e054-00144ff8d46c 13733-211 HUMAN OTC DRUG MISSHA All Around Safe Block Waterproof Sun Zinc Oxide CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 Able C&C ZINC OXIDE 24 mg/g N 20181231 13733-212_4db3ed71-209a-167e-e054-00144ff8d46c 13733-212 HUMAN OTC DRUG MISSHA All Around Safe Block Sebum Zero Sun Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 Able C&C ZINC OXIDE; TITANIUM DIOXIDE 5.28; 4.15 mg/g; mg/g N 20181231 13733-213_4db3ed71-2089-167e-e054-00144ff8d46c 13733-213 HUMAN OTC DRUG MISSHA All Around Safe Block Mild Sun SPF30 Zinc Oxide, Titanium dioxide CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE 4.8; 4.15 mg/g; mg/g N 20181231 13733-214_4db40056-bfab-7329-e054-00144ff88e88 13733-214 HUMAN OTC DRUG MISSHA All Around Safe Block Fresh Sun SPF50 Octinoxate, Octocrylene, Octisalate, Avobenzone STICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd OCTOCRYLENE; OCTISALATE; AVOBENZONE; OCTINOXATE 5; 4.5; 3; 7 mg/g; mg/g; mg/g; mg/g N 20181231 13733-215_4db5476c-9dc5-28fb-e054-00144ff88e88 13733-215 HUMAN OTC DRUG The Sytle Fitting Wear Cashmere SPF15 No.1 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 Able C&C TITANIUM DIOXIDE; OCTINOXATE 1.94; 1.8 mg/g; mg/g N 20181231 13733-216_4db5476c-9dc5-28fb-e054-00144ff88e88 13733-216 HUMAN OTC DRUG The Sytle Fitting Wear Cashmere SPF15 No.2 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 Able C&C TITANIUM DIOXIDE; OCTINOXATE 1.94; 1.8 mg/g; mg/g N 20181231 13733-217_529342cb-b54c-6651-e054-00144ff88e88 13733-217 HUMAN OTC DRUG MISSHA All Around Safe Block Sun Milk For Men SPF50 40ML Zinc Oxide CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.1865; 7.5; 6.9 mg/g; mg/g; mg/g N 20181231 13733-218_529342cb-b54c-6651-e054-00144ff88e88 13733-218 HUMAN OTC DRUG MISSHA All Around Safe Block Sun Milk For Men SPF50 70ML Zinc Oxide CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.1865; 7.5; 6.9 mg/g; mg/g; mg/g N 20181231 13733-220_4db493a9-78d7-3717-e054-00144ff8d46c 13733-220 HUMAN OTC DRUG MISSHA M Perfect Cover BB SPF42 No23 Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20160922 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .075; .042; .07 g/g; g/g; g/g N 20181231 13733-221_4db45f8e-b7de-17f0-e054-00144ff88e88 13733-221 HUMAN OTC DRUG MISSHA Signature Volume Brightening Concealer SPF30 No21 Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 13.2; 4; .98 mg/g; mg/g; mg/g N 20181231 13733-222_4db45f8e-b7de-17f0-e054-00144ff88e88 13733-222 HUMAN OTC DRUG MISSHA Signature Volume Brightening Concealer SPF30 No23 Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 13.2; 4; .98 mg/g; mg/g; mg/g N 20181231 13733-223_4db3ed71-2074-167e-e054-00144ff8d46c 13733-223 HUMAN OTC DRUG MISA Cho Bo Yang BB SPF30 No23 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE 1.44; 10.44 mg/g; mg/g N 20181231 13733-224_4db3ed71-2074-167e-e054-00144ff8d46c 13733-224 HUMAN OTC DRUG MISA Cho Bo Yang BB SPF30 No21 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE 1.44; 10.44 mg/g; mg/g N 20181231 13733-225_4db45f8e-b7d1-17f0-e054-00144ff88e88 13733-225 HUMAN OTC DRUG MISSHA The Style Fitting Wear Foundation SPF30 No21 Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20160921 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .04; .109; .01 g/g; g/g; g/g N 20181231 13733-226_4db45f8e-b7d1-17f0-e054-00144ff88e88 13733-226 HUMAN OTC DRUG MISSHA The Style Fitting Wear Foundation SPF30 No23 Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20160921 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .109; .04; .01 g/g; g/g; g/g N 20181231 13733-230_52934952-1b0c-3edb-e054-00144ff8d46c 13733-230 HUMAN OTC DRUG MISSHA M Magic Cushion Cover SPF50 NO31 Titanium Dioxide, Octinoxate, Octisalate LOTION TOPICAL 20160921 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTISALATE; TITANIUM DIOXIDE; OCTINOXATE .04; .093; .067 g/g; g/g; g/g N 20181231 13733-232_598e9653-931e-3bfe-e053-2a91aa0afcbe 13733-232 HUMAN OTC DRUG MISA Geum Sul Vitalizing Day SPF15 Octinoxate, Titanium Dioxide CREAM TOPICAL 20160921 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE .026; .07 g/g; g/g N 20181231 13733-233_4f0518bb-e818-2d2c-e054-00144ff8d46c 13733-233 HUMAN OTC DRUG Time Revolution White Cure Blanc Tone Up Sun Protector Zinc Oxide, Octinoxate, Octisalate, Titanium Dioxide CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE 7; 10.2; 2; .7 mg/g; mg/g; mg/g; mg/g N 20181231 13733-234_4db375f0-270b-7200-e054-00144ff88e88 13733-234 HUMAN OTC DRUG All Around Safe Block Aqua Sun Gel Octinoxate, Octocrylene, Octisalate, Avobenzone GEL CUTANEOUS 20170301 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTOCRYLENE; OCTINOXATE; OCTISALATE; AVOBENZONE 5; 7; 4.5; 3 mg/g; mg/g; mg/g; mg/g N 20181231 13733-235_4db388ef-6619-6703-e054-00144ff8d46c 13733-235 HUMAN OTC DRUG All Around Safe Block Essence Sun Octinoxate, Octisalate, Ensulizole CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; OCTISALATE; ENSULIZOLE 7; 4.8; 4 mg/g; mg/g; mg/g N 20181231 13733-236_570ea921-807f-3559-e054-00144ff8d46c 13733-236 HUMAN OTC DRUG MISA Geum Sul Vitalizing BB Cake 21 Titanium Dioxide, Octinoxate POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE 5.5; 16.4 mg/g; mg/g N 20181231 13733-237_570ea921-807f-3559-e054-00144ff8d46c 13733-237 HUMAN OTC DRUG MISA Geum Sul Vitalizing BB Cake 23 Titanium Dioxide, Octinoxate POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE 5.5; 16.4 mg/g; mg/g N 20181231 13733-245_4db4b5ed-22a2-3cf9-e054-00144ff8d46c 13733-245 HUMAN OTC DRUG MISSHA M Perfect Cover BB SPF42 No29 Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20161001 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .075; .042; .07 g/g; g/g; g/g N 20181231 13733-270_4db429a6-b07f-224a-e054-00144ff8d46c 13733-270 HUMAN OTC DRUG MISSHA The Original Tension Pact Perfect Cover SPF37 No 13 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 12.6; 2.94 mg/g; mg/g; mg/g N 20181231 13733-271_4db429a6-b07f-224a-e054-00144ff8d46c 13733-271 HUMAN OTC DRUG MISSHA The Original Tension Pact Perfect Cover SPF37 No 21 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 12.6; 2.94 mg/g; mg/g; mg/g N 20181231 13733-272_4db429a6-b07f-224a-e054-00144ff8d46c 13733-272 HUMAN OTC DRUG MISSHA The Original Tension Pact Perfect Cover SPF37 No 23 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 12.6; 2.94 mg/g; mg/g; mg/g N 20181231 13733-276_4fe894e1-078a-5b2e-e054-00144ff8d46c 13733-276 HUMAN OTC DRUG Frida Kahlo Edition Tension Pact Perfect Cover SPF37 No 21 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 12.6; 2.9 mg/g; mg/g; mg/g N 20181231 13733-277_4fe894e1-078a-5b2e-e054-00144ff8d46c 13733-277 HUMAN OTC DRUG Frida Kahlo Edition Tension Pact Perfect Cover SPF37 No 23 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 12.6; 2.94 mg/g; mg/g; mg/g N 20181231 13733-278_4fe80d9b-2869-4e20-e054-00144ff88e88 13733-278 HUMAN OTC DRUG Frida Kahlo Edition Tension Pact Perfect Cover SPF37 No 27 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 10.6; 2.9 mg/g; mg/g; mg/g N 20181231 13733-279_4fe8d593-c19e-5648-e054-00144ff8d46c 13733-279 HUMAN OTC DRUG Frida Kahlo Edition Tension Pact Perfect Cover SPF37 No 29 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 10.2; 2.9 mg/g; mg/g; mg/g N 20181231 13733-283_526c99e4-8c2c-1e52-e054-00144ff88e88 13733-283 HUMAN OTC DRUG Frida Kahlo Edition Tension Pact Perfect Cover SPF37 No 31 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 10.2; 2.9 mg/g; mg/g; mg/g N 20181231 13733-290_4db3270d-e9b1-6436-e054-00144ff88e88 13733-290 HUMAN OTC DRUG MISSHA The Original Tension Pact Intense Moisture SPF37 No13 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 9.69; 2.94 mg/g; mg/g; mg/g N 20181231 13733-291_4db3270d-e9b1-6436-e054-00144ff88e88 13733-291 HUMAN OTC DRUG MISSHA The Original Tension Pact Intense Moisture SPF37 No21 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 9.69; 2.94 mg/g; mg/g; mg/g N 20181231 13733-292_4db3270d-e9b1-6436-e054-00144ff88e88 13733-292 HUMAN OTC DRUG MISSHA The Original Tension Pact Intense Moisture SPF37 No23 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 9.69; 2.94 mg/g; mg/g; mg/g N 20181231 13733-296_4fe8d47a-406b-65cf-e054-00144ff88e88 13733-296 HUMAN OTC DRUG Frida Kahlo Edition Tension Pact Intense Moisture SPF37 No21 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 9.7; 2.9 mg/g; mg/g; mg/g N 20181231 13733-297_4fe8d47a-406b-65cf-e054-00144ff88e88 13733-297 HUMAN OTC DRUG Frida Kahlo Edition Tension Pact Intense Moisture SPF37 No23 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 9.7; 2.9 mg/g; mg/g; mg/g N 20181231 13733-298_4fe916c8-ac0d-03be-e054-00144ff8d46c 13733-298 HUMAN OTC DRUG Frida Kahlo Edition Tension Pact Intense Moisture SPF37 No27 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 10.6; 2.9 mg/g; mg/g; mg/g N 20181231 13733-299_4fe98406-99ae-049b-e054-00144ff88e88 13733-299 HUMAN OTC DRUG Frida Kahlo Edition Tension Pact Intense Moisture SPF37 No29 Titanium Dioxide, Octinoxate, Zinc Oxide, CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 5; 10.2; 2.9 mg/g; mg/g; mg/g N 20181231 13733-301_4db3ed71-20c7-167e-e054-00144ff8d46c 13733-301 HUMAN OTC DRUG Near Skin Dustless Defense Sunblock Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide LOTION CUTANEOUS 20170301 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 7.5; 5; 4.9; 2.9 mg/g; g/g; mg/g; mg/g N 20181231 13733-310_52a7c7e2-b964-3929-e054-00144ff88e88 13733-310 HUMAN OTC DRUG MISSHA M MAGIC CUSHION NO 21 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 ABLE C&C Co., Ltd. TITANIUM DIOXIDE; OCTISALATE; OCTINOXATE 2; .6; 1 g/15g; g/15g; g/15g N 20181231 13733-311_52a7c7e2-b964-3929-e054-00144ff88e88 13733-311 HUMAN OTC DRUG MISSHA M MAGIC CUSHION NO 23 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 ABLE C&C Co., Ltd. TITANIUM DIOXIDE; OCTISALATE; OCTINOXATE 2; .6; 1 g/15g; g/15g; g/15g N 20181231 13733-313_528fd975-f95a-011d-e054-00144ff8d46c 13733-313 HUMAN OTC DRUG MISSHA M Magic Cushion SPF50 NO31 Titanium Dioxide, Octinoxate, Octisalate LOTION TOPICAL 20160921 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTISALATE; TITANIUM DIOXIDE; OCTINOXATE .04; .093; .067 g/g; g/g; g/g N 20181231 13733-316_5347d825-a757-3f48-e054-00144ff88e88 13733-316 HUMAN OTC DRUG All Around Safe Block Essence Sun Octinoxate, Octisalate, Ensulizole CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 ABLE C&C CO., LTD. OCTINOXATE; OCTISALATE; ENSULIZOLE 7; 4.8; 4 mg/g; mg/g; mg/g N 20181231 13733-317_5345dbaf-9551-6d0c-e054-00144ff88e88 13733-317 HUMAN OTC DRUG Missha Signature Aura Tension Deep Moisture No 21 Titanium Dioxide, Octinoxate, Zinc Oxide LOTION TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 96.9; 29.4; 5 mg/g; mg/g; mg/g N 20181231 13733-318_5345dbaf-9551-6d0c-e054-00144ff88e88 13733-318 HUMAN OTC DRUG Missha Signature Aura Tension Deep Moisture No 23 Titanium Dioxide, Octinoxate, Zinc Oxide LOTION TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 96.9; 29.4; 5 mg/g; mg/g; mg/g N 20181231 13733-321_5320b2fc-06e4-48ca-e054-00144ff88e88 13733-321 HUMAN OTC DRUG MISSHA Signature Essence Cushion No 21 Titanium Dioxide, Octinoxate, Octisalate LOTION TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 8.9; 6.7; 4 mg/g; mg/g; mg/g N 20181231 13733-322_5320b2fc-06e4-48ca-e054-00144ff88e88 13733-322 HUMAN OTC DRUG MISSHA Signature Essence Cushion No 23 Titanium Dioxide, Octinoxate, Octisalate LOTION TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 8.9; 6.7; 4 mg/g; mg/g; mg/g N 20181231 13733-323_570e93a1-8e8d-2470-e054-00144ff88e88 13733-323 HUMAN OTC DRUG MISSHA M SIGNATURE REAL COMPLETE BB NO27 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 ABLE C&C Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 7.72; 3.84 mg/g; mg/g N 20181231 13733-324_549b9cba-703f-5a33-e054-00144ff8d46c 13733-324 HUMAN OTC DRUG MISSHA All Around Safe Block Waterproof Sun Zinc Oxide CREAM TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Able C&C ZINC OXIDE 24 mg/g N 20181231 13733-325_548b04a9-6081-0251-e054-00144ff88e88 13733-325 HUMAN OTC DRUG MISSHA All Around Safe Block Sebum Zero Sun Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Able C&C ZINC OXIDE; TITANIUM DIOXIDE 5.28; 4.15 mg/g; mg/g N 20181231 13733-326_5498cd1e-76f7-5223-e054-00144ff88e88 13733-326 HUMAN OTC DRUG All Around Safe Block Aqua Sun Gel Octinoxate, Octocrylene, Octisalate, Avobenzone GEL CUTANEOUS 20170701 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTOCRYLENE; OCTINOXATE; OCTISALATE; AVOBENZONE 5; 7; 4.5; 3 mg/g; mg/g; mg/g; mg/g N 20181231 13733-328_549b9cba-704f-5a33-e054-00144ff8d46c 13733-328 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK SOFT FINISH SUN MILK 70ML Zinc Oxide, Octinoxate, Octisalate, Titanium Dioxide LOTION TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; OCTISALATE; OCTINOXATE; ZINC OXIDE 1.743; 2.1; 2.1; 3.696 g/70g; g/70g; g/70g; g/70g N 20181231 13733-329_549b9cba-704f-5a33-e054-00144ff8d46c 13733-329 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK SOFT FINISH SUN MILK 40ML Zinc Oxide, Octinoxate, Octisalate, Titanium Dioxide LOTION TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTISALATE; TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.2; .996; 1.2; 2.112 g/40g; g/40g; g/40g; g/40g N 20181231 13733-330_549bc21c-6c9a-37f3-e054-00144ff88e88 13733-330 HUMAN OTC DRUG MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK 70ML Octinoxate, Octocrylene, Octisalate, Avobenzone LOTION TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 4.9; 3.5; 3.15; 2.1 g/70g; g/70g; g/70g; g/70g N 20181231 13733-331_5d1c22dc-8ebe-1514-e053-2991aa0a62f3 13733-331 HUMAN OTC DRUG MISSHA All Around Safe Block Toning Sun Tension SPF50 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20171103 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE 2.448; .8466 g/17g; g/17g N 20181231 13733-332_5f25d52c-3334-f3d0-e053-2a91aa0a3a82 13733-332 HUMAN OTC DRUG MISSHA M Signature Real Complete BB Cream SPF25 No.13 Bright Milky Beige Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.252645; 1.728 g/45g; g/45g N 20181231 13733-333_5e81c776-774e-4060-e053-2991aa0a918f 13733-333 HUMAN OTC DRUG MISSHA M Signature Real Complete BB Cream SPF25 No.21 Light Pink Beige Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.4731; 1.728 g/45g; g/45g N 20181231 13733-334_5efe7b9b-4b8e-5040-e053-2991aa0a036b 13733-334 HUMAN OTC DRUG MISSHA M Signature Real Complete BB Cream SPF25 No.23 Natural Yellow Beige Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.4731; 1.728 g/45g; g/45g N 20181231 13733-336_5e808466-e709-7c0b-e053-2991aa0a9142 13733-336 HUMAN OTC DRUG MISSHA Pore-fection BB Cream SPF30 No.1 Light Beige Titanium Dioxide, Octisalate, Zinc Oxide CREAM TOPICAL 20171116 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 1.2; .2942352; 4.125492 g/30mL; g/30mL; g/30mL N 20181231 13733-337_5e80d1e8-4919-5cd1-e053-2991aa0ae44a 13733-337 HUMAN OTC DRUG MISSHA Pore-fection BB Cream SPF30 No.2 Natural Beige Titanium Dioxide, Octisalate, Zinc Oxide CREAM TOPICAL 20171116 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 1.2; .2942352; 4.125492 g/30mL; g/30mL; g/30mL N 20181231 13733-345_5df51314-001d-edd4-e053-2991aa0ab928 13733-345 HUMAN OTC DRUG MISSHA Skin Fit Stick Foundation SPF50 No.21 ZINC OXIDE, TITANIUM DIOXIDE, OCTISALATE, OCTINOXATE, OCTOCRYLENE STICK TOPICAL 20171116 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE; OCTOCRYLENE; OCTINOXATE; OCTISALATE .9408; 3.04185; .42; .98; .63 g/14g; g/14g; g/14g; g/14g; g/14g N 20181231 13733-346_5e81190a-3e5d-1a69-e053-2a91aa0ad620 13733-346 HUMAN OTC DRUG MISSHA Skin Fit Stick Foundation SPF50 No.23 ZINC OXIDE, TITANIUM DIOXIDE, OCTISALATE, OCTINOXATE, OCTOCRYLENE STICK TOPICAL 20171116 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTOCRYLENE; ZINC OXIDE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .42; .9408; .98; .63; 3.04185 g/14g; g/14g; g/14g; g/14g; g/14g N 20181231 13733-350_5df53b9c-c4d0-7006-e053-2a91aa0aeeac 13733-350 HUMAN OTC DRUG MISSHA M Essential Care Lip Treatment SPF15 OCTISALATE, OCTINOXATE LIQUID TOPICAL 20171115 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. OCTISALATE; OCTINOXATE .39; .78 g/13mL; g/13mL N 20181231 13733-360_5f2611e0-54cd-6588-e053-2991aa0a1a5f 13733-360 HUMAN OTC DRUG MISSHA Time Revolution Night Repair Science Activator Ampoule NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20171103 UNAPPROVED DRUG OTHER Able C&C Co., Ltd. ADENOSINE; NIACINAMIDE 20; 1 mg/50mL; g/50mL N 20181231 13733-361_5f271364-3fba-19ea-e053-2a91aa0a8ff5 13733-361 HUMAN OTC DRUG MISSHA TIME REVOLUTION NIGHT REPAIR NEW SCIENCE ACTIVATOR AMPOULE MASK ADENOSINE, NIACINAMIDE PATCH TOPICAL 20171108 UNAPPROVED DRUG OTHER Able C&C Co., Ltd. NIACINAMIDE; ADENOSINE .66; .132 g/33mL; g/33mL N 20181231 13733-370_5f262632-ae94-7953-e053-2a91aa0a6b10 13733-370 HUMAN OTC DRUG MISSHA Time Revolution The First Treatment Essence Intensive NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20171107 UNAPPROVED DRUG OTHER Able C&C Co., Ltd. NIACINAMIDE; ADENOSINE 3; .06 g/150mL; g/150mL N 20181231 13733-371_5f2610d2-9a65-6586-e053-2991aa0ac10e 13733-371 HUMAN OTC DRUG MISSHA Time Revolution The First Treatment Essence Mask ADENOSINE PATCH TOPICAL 20171108 UNAPPROVED DRUG OTHER Able C&C Co., Ltd. ADENOSINE 13.2 mg/33mL N 20181231 13733-380_5f265bec-3bba-3b4f-e053-2991aa0a0f5b 13733-380 HUMAN OTC DRUG MISSHA TIME REVOLUTION VITALITY SERUM ADENOSINE LIQUID TOPICAL 20171103 UNAPPROVED DRUG OTHER Able C&C Co., Ltd. ADENOSINE 16 mg/40mL N 20181231 13733-381_5f26be2c-0036-28c2-e053-2a91aa0aee9b 13733-381 HUMAN OTC DRUG MISSHA Time Revolution Vitality Eye Cream ADENOSINE CREAM TOPICAL 20171103 UNAPPROVED DRUG OTHER Able C&C Co., Ltd. ADENOSINE 10 mg/25mL N 20181231 13733-382_5f260068-68cf-529d-e053-2991aa0a0eea 13733-382 HUMAN OTC DRUG MISSHA Time Revolution Immortal Youth Blue Essence NIACINAMIDE, ADENOSINE EMULSION TOPICAL 20171103 UNAPPROVED DRUG OTHER Able C&C Co., Ltd. NIACINAMIDE; ADENOSINE 1.6; 32 g/80mL; mg/80mL N 20181231 13733-390_5f0e6622-e36a-be9f-e053-2991aa0ae47f 13733-390 HUMAN OTC DRUG MISSHA All Around Safe Block Daily Sun For Men SPF50 Homosalate, Octisalate, Avobenzone, Octocrylene LOTION TOPICAL 20171108 OTC MONOGRAPH NOT FINAL part352 Able C&C Co., Ltd. AVOBENZONE; OCTOCRYLENE; HOMOSALATE; OCTISALATE 1.5; .5; 3.5; 2.25 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 13734-022_cc162aac-e25d-41b3-88f8-707a037ed471 13734-022 HUMAN OTC DRUG PURE SHEER Aurore Octinoxate and Titanium dioxide LIPSTICK TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE .1258; .0544 g/1.7g; g/1.7g E 20171231 13734-023_cc162aac-e25d-41b3-88f8-707a037ed471 13734-023 HUMAN OTC DRUG PURE SHEER Greta Octinoxate and Titanium dioxide LIPSTICK TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE .1258; .0544 g/1.7g; g/1.7g E 20171231 13734-024_cc162aac-e25d-41b3-88f8-707a037ed471 13734-024 HUMAN OTC DRUG PURE SHEER Paloma Octinoxate and Titanium dioxide LIPSTICK TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE .1258; .0544 g/1.7g; g/1.7g E 20171231 13734-025_cc162aac-e25d-41b3-88f8-707a037ed471 13734-025 HUMAN OTC DRUG PURE SHEER Lara Octinoxate and Titanium dioxide LIPSTICK TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE .1258; .0544 g/1.7g; g/1.7g E 20171231 13734-026_cc162aac-e25d-41b3-88f8-707a037ed471 13734-026 HUMAN OTC DRUG PURE SHEER Angelique Octinoxate and Titanium dioxide LIPSTICK TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE .1258; .0544 g/1.7g; g/1.7g E 20171231 13734-027_cc162aac-e25d-41b3-88f8-707a037ed471 13734-027 HUMAN OTC DRUG PURE SHEER Bianca Octinoxate and Titanium dioxide LIPSTICK TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE .1258; .0544 g/1.7g; g/1.7g E 20171231 13734-101_6e8d4e9b-83ee-46b8-8f52-913f8068ace7 13734-101 HUMAN OTC DRUG NARS PRO-PRIME MULTI-PROTECT PRIMER AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 922; 3072; 922; 768; 1229 mg/30.72g; mg/30.72g; mg/30.72g; mg/30.72g; mg/30.72g E 20171231 13734-102_05c3def6-b2ac-4475-a18e-c03bc2d67c31 13734-102 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Finland OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g N 20181231 13734-103_05c3def6-b2ac-4475-a18e-c03bc2d67c31 13734-103 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Alaska OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g N 20181231 13734-104_05c3def6-b2ac-4475-a18e-c03bc2d67c31 13734-104 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Annapurna OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g N 20181231 13734-105_05c3def6-b2ac-4475-a18e-c03bc2d67c31 13734-105 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER St. Moritz OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g N 20181231 13734-106_05c3def6-b2ac-4475-a18e-c03bc2d67c31 13734-106 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Cuba OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g N 20181231 13734-107_05c3def6-b2ac-4475-a18e-c03bc2d67c31 13734-107 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Malaga OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g N 20181231 13734-108_05c3def6-b2ac-4475-a18e-c03bc2d67c31 13734-108 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Seychelles OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g N 20181231 13734-109_05c3def6-b2ac-4475-a18e-c03bc2d67c31 13734-109 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Martinique OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g N 20181231 13734-110_05c3def6-b2ac-4475-a18e-c03bc2d67c31 13734-110 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Polynesia OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g N 20181231 13734-111_05c3def6-b2ac-4475-a18e-c03bc2d67c31 13734-111 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Terre-Neuve OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g N 20181231 13734-112_05c3def6-b2ac-4475-a18e-c03bc2d67c31 13734-112 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Groenland OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g N 20181231 13734-113_410cd3bf-72d2-4dfd-afbd-0e568c354f3b 13734-113 HUMAN OTC DRUG NARS PRO-PRIME LIGHT OPTIMIZING PRIMER OCTINOXATE, AVOBENZONE, and OCTOCRYLENE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; AVOBENZONE; OCTOCRYLENE 63; 27; 21 mg/1.072g; mg/1.072g; mg/1.072g E 20171231 13734-114_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-114 HUMAN OTC DRUG NARS FOUNDATION Barcelona OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-115_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-115 HUMAN OTC DRUG NARS FOUNDATION Benares OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-116_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-116 HUMAN OTC DRUG NARS FOUNDATION Cadiz OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-117_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-117 HUMAN OTC DRUG NARS FOUNDATION Deauville OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-118_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-118 HUMAN OTC DRUG NARS FOUNDATION Fiji OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-119_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-119 HUMAN OTC DRUG NARS FOUNDATION Mont Blanc OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-120_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-120 HUMAN OTC DRUG NARS FOUNDATION New Orleans OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-121_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-121 HUMAN OTC DRUG NARS FOUNDATION Punjab OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-122_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-122 HUMAN OTC DRUG NARS FOUNDATION Santa Fe OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-123_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-123 HUMAN OTC DRUG NARS FOUNDATION Siberia OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-124_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-124 HUMAN OTC DRUG NARS FOUNDATION Stromboli OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-125_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-125 HUMAN OTC DRUG NARS FOUNDATION Syracuse OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-126_a5826ad3-eaa0-4137-9750-4551a2ab704f 13734-126 HUMAN OTC DRUG NARS FOUNDATION Tahoe OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 588; 792 mg/12g; mg/12g E 20171231 13734-127_94c6895d-8079-4e9b-b7a2-f48f9c9579d7 13734-127 HUMAN OTC DRUG NARS PURE SHEER SPF LIP TREATMENT Angelique OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 126; 54 mg/1.7g; mg/1.7g N 20181231 13734-128_0a57497f-0f71-4fa9-8377-d05484978930 13734-128 HUMAN OTC DRUG NARS PURE SHEER SPF LIP TREATMENT Bianca OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 126; 54 mg/1.7g; mg/1.7g N 20181231 13734-129_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-129 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Siberia Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g N 20181231 13734-130_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-130 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Mont Blanc Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g N 20181231 13734-131_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-131 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Deauville Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g N 20181231 13734-132_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-132 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Sweden Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g N 20181231 13734-133_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-133 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Fiji Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g N 20181231 13734-134_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-134 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Punjab Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g N 20181231 13734-135_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-135 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Santa Fe Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g N 20181231 13734-136_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-136 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Barcelona Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g N 20181231 13734-137_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-137 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Laponie Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g N 20181231 13734-138_b1fe28fb-ee26-43b4-973a-846118bf53dd 13734-138 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Vallauris Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 588; 996 mg/12g; mg/12g N 20181231 13734-139_d782efbf-4665-4d7e-872c-c231fcd5d079 13734-139 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Stromboli Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 690; 830 mg/10g; mg/10g N 20181231 13734-140_d782efbf-4665-4d7e-872c-c231fcd5d079 13734-140 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Tahoe Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 690; 830 mg/10g; mg/10g N 20181231 13734-141_d782efbf-4665-4d7e-872c-c231fcd5d079 13734-141 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Syracuse Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 690; 830 mg/10g; mg/10g N 20181231 13734-142_d782efbf-4665-4d7e-872c-c231fcd5d079 13734-142 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Cadiz Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 690; 830 mg/10g; mg/10g N 20181231 13734-143_d782efbf-4665-4d7e-872c-c231fcd5d079 13734-143 HUMAN OTC DRUG NARS ALL DAY LUMINOUS FOUNDATION Macao Octinoxate and Titanium Dioxide POWDER TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 NARS COSMETICS OCTINOXATE; TITANIUM DIOXIDE 690; 830 mg/10g; mg/10g N 20181231 13734-144_d6a5d1ec-2292-42ef-b191-92a4d13b950a 13734-144 HUMAN OTC DRUG NARS VELVET MATTE SKIN TINT TERRE-NEUVE OCTINOXATE and OCTISALATE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; OCTISALATE 3712.5; 1485 mg/50mL; mg/50mL N 20181231 13734-145_d6a5d1ec-2292-42ef-b191-92a4d13b950a 13734-145 HUMAN OTC DRUG NARS VELVET MATTE SKIN TINT FINLAND OCTINOXATE and OCTISALATE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; OCTISALATE 3712.5; 1485 mg/50mL; mg/50mL N 20181231 13734-146_d6a5d1ec-2292-42ef-b191-92a4d13b950a 13734-146 HUMAN OTC DRUG NARS VELVET MATTE SKIN TINT ALASKA OCTINOXATE and OCTISALATE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; OCTISALATE 3712.5; 1485 mg/50mL; mg/50mL N 20181231 13734-147_d6a5d1ec-2292-42ef-b191-92a4d13b950a 13734-147 HUMAN OTC DRUG NARS VELVET MATTE SKIN TINT GROENLAND OCTINOXATE and OCTISALATE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; OCTISALATE 3712.5; 1485 mg/50mL; mg/50mL N 20181231 13734-148_d6a5d1ec-2292-42ef-b191-92a4d13b950a 13734-148 HUMAN OTC DRUG NARS VELVET MATTE SKIN TINT ST. MORITZ OCTINOXATE and OCTISALATE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; OCTISALATE 3712.5; 1485 mg/50mL; mg/50mL N 20181231 13734-149_d6a5d1ec-2292-42ef-b191-92a4d13b950a 13734-149 HUMAN OTC DRUG NARS VELVET MATTE SKIN TINT CUZCO OCTINOXATE and OCTISALATE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; OCTISALATE 3712.5; 1485 mg/50mL; mg/50mL N 20181231 13734-150_d6a5d1ec-2292-42ef-b191-92a4d13b950a 13734-150 HUMAN OTC DRUG NARS VELVET MATTE SKIN TINT ANNAPURNA OCTINOXATE and OCTISALATE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; OCTISALATE 3712.5; 1485 mg/50mL; mg/50mL N 20181231 13734-151_d6a5d1ec-2292-42ef-b191-92a4d13b950a 13734-151 HUMAN OTC DRUG NARS VELVET MATTE SKIN TINT CUBA OCTINOXATE and OCTISALATE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; OCTISALATE 3712.5; 1485 mg/50mL; mg/50mL N 20181231 13734-152_d6a5d1ec-2292-42ef-b191-92a4d13b950a 13734-152 HUMAN OTC DRUG NARS VELVET MATTE SKIN TINT MALAGA OCTINOXATE and OCTISALATE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; OCTISALATE 3712.5; 1485 mg/50mL; mg/50mL N 20181231 13734-153_d6a5d1ec-2292-42ef-b191-92a4d13b950a 13734-153 HUMAN OTC DRUG NARS VELVET MATTE SKIN TINT SEYCHELLES OCTINOXATE and OCTISALATE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; OCTISALATE 3712.5; 1485 mg/50mL; mg/50mL N 20181231 13734-154_d6a5d1ec-2292-42ef-b191-92a4d13b950a 13734-154 HUMAN OTC DRUG NARS VELVET MATTE SKIN TINT MARTINIQUE OCTINOXATE and OCTISALATE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; OCTISALATE 3712.5; 1485 mg/50mL; mg/50mL N 20181231 13734-155_d6a5d1ec-2292-42ef-b191-92a4d13b950a 13734-155 HUMAN OTC DRUG NARS VELVET MATTE SKIN TINT POLYNESIA OCTINOXATE and OCTISALATE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; OCTISALATE 3712.5; 1485 mg/50mL; mg/50mL N 20181231 13734-156_05c3def6-b2ac-4475-a18e-c03bc2d67c31 13734-156 HUMAN OTC DRUG NARS PURE RADIANT TINTED MOISTURIZER Cuzco OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics OCTINOXATE; TITANIUM DIOXIDE 4070; 3355 mg/55g; mg/55g N 20181231 13734-157_3035314c-55f7-4940-ac2f-d42dd3e82f57 13734-157 HUMAN OTC DRUG NARS SMOOTH and PROTECT PRIMER AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 741.7; 2967; 1483.5; 1483.5; 1483.5 mg/30mL; mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 13734-158_c4cc881c-9a4a-48c6-a87f-c13220e87d82 13734-158 HUMAN OTC DRUG NARS RADIANCE PRIMER AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 602.4; 1807.2; 1506; 481.9 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 13734-159_9bf7afd3-936b-46a4-ac61-578ed68f224b 13734-159 HUMAN OTC DRUG NARS LAGUNA BODY TINT AVOBENZONE, HOMOSALATE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20170315 OTC MONOGRAPH NOT FINAL part352 NARS Cosmetics AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3300; 11000; 8140; 5500 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 13811-544_18dad510-8579-43c7-9039-efb6e1d19dce 13811-544 HUMAN PRESCRIPTION DRUG Folivane-PRx DHA Ascorbic Acid, Tribasic Calcium Phosphate, Iron, Cholecalciferol, Alpha-Tocopherol, Pyridoxine Hydrochloride, Folic Acid, Doconexent, and Docusate Sodium CAPSULE ORAL 20100101 UNAPPROVED DRUG OTHER TRIGEN Laboratories, Inc. ASCORBIC ACID; TRIBASIC CALCIUM PHOSPHATE; IRON; CHOLECALCIFEROL; ALPHA-TOCOPHEROL; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; DOCONEXENT; DOCUSATE SODIUM 25; 160; 30; 170; 30; 25; 1.24; 265; 55 mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 13811-598_5f3ba56d-efd2-4361-b40c-045019f0a2cd 13811-598 HUMAN PRESCRIPTION DRUG VemaVite-PRx 2 with Fish-Based DHA Ascorbic Acid, Tribasic Calcium Phosphate, Ferrous Fumarate, Cholecalciferol, Alpha-Tocopherol, Pyridoxine Hydrochloride, Folic Acid, Doconexent, and Docusate Sodium CAPSULE ORAL 20111005 UNAPPROVED DRUG OTHER TRIGEN Laboratories, Inc. ASCORBIC ACID; TRIBASIC CALCIUM PHOSPHATE; FERROUS FUMARATE; CHOLECALCIFEROL; ALPHA-TOCOPHEROL; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; DOCONEXENT; DOCUSATE SODIUM 28; 160; 27; 400; 30; 25; 1.25; 300; 55 mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 13811-606_cc555edb-3499-48b7-a968-c0d54d5be9b0 13811-606 HUMAN PRESCRIPTION DRUG TL-HEM 150 Ascorbic Acid, .Alpha.-Tocopherol Acetate, DL-, Folic Acid, Cyanocobalamin, Biotin, Iron, Cupric Sulfate, and Docusate Sodium TABLET, FILM COATED ORAL 20110101 UNAPPROVED DRUG OTHER TRIGEN Laboratories, Inc. ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, DL-; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; IRON; CUPRIC SULFATE; DOCUSATE SODIUM 500; 30; 1; 60; 150; 150; 3; 50 mg/1; [iU]/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 13811-621_aee7e0ad-d868-4652-be59-ba508d0beacb 13811-621 HUMAN PRESCRIPTION DRUG LEVETIRACETAM Levetiracetam TABLET, FILM COATED ORAL 20120331 ANDA ANDA090906 Trigen Laboratories, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 13811-627_df70c619-a81f-48c3-8ec7-0135dc1fb450 13811-627 HUMAN PRESCRIPTION DRUG benazepril hydrochloride Benazepril hydrochloride TABLET, FILM COATED ORAL 20121115 ANDA ANDA076118 Trigen Laboratories, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 13811-628_df70c619-a81f-48c3-8ec7-0135dc1fb450 13811-628 HUMAN PRESCRIPTION DRUG BENAZEPRIL HYDROCHLORIDE Benazepril hydrochloride TABLET, FILM COATED ORAL 20121115 ANDA ANDA076118 Trigen Laboratories, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 13811-629_df70c619-a81f-48c3-8ec7-0135dc1fb450 13811-629 HUMAN PRESCRIPTION DRUG BENAZEPRIL HYDROCHLORIDE Benazepril hydrochloride TABLET, FILM COATED ORAL 20121115 ANDA ANDA076118 Trigen Laboratories, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 13811-630_df70c619-a81f-48c3-8ec7-0135dc1fb450 13811-630 HUMAN PRESCRIPTION DRUG BENAZEPRIL HYDROCHLORIDE Benazepril hydrochloride TABLET, FILM COATED ORAL 20121115 ANDA ANDA076118 Trigen Laboratories, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 13811-639_91d4097e-1fe7-47db-be29-b4dcc999dfa5 13811-639 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130314 ANDA ANDA202786 Trigen Laboratories, LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 13811-640_91d4097e-1fe7-47db-be29-b4dcc999dfa5 13811-640 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130314 ANDA ANDA202786 Trigen Laboratories, LLC ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 13811-641_91d4097e-1fe7-47db-be29-b4dcc999dfa5 13811-641 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130314 ANDA ANDA202786 Trigen Laboratories, LLC ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 13811-642_91d4097e-1fe7-47db-be29-b4dcc999dfa5 13811-642 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130314 ANDA ANDA202786 Trigen Laboratories, LLC ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 13811-643_91d4097e-1fe7-47db-be29-b4dcc999dfa5 13811-643 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130314 ANDA ANDA202786 Trigen Laboratories, LLC ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 13811-646_a87565d9-fc68-4414-8063-4152d3e3e002 13811-646 HUMAN OTC DRUG Meclizine HCl MECLIZINE HYDROCHLORIDE TABLETS TABLET ORAL 20130923 OTC MONOGRAPH FINAL part336 Trigen Laboratories, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 13811-647_cdc36345-d71d-43f7-bc03-0738c6f1ebaa 13811-647 HUMAN OTC DRUG Meclizine HCl MECLIZINE HYDROCHLORIDE TABLETS TABLET ORAL 20130923 OTC MONOGRAPH FINAL part336 Trigen Laboratories, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 13811-648_79a4bd44-386d-4756-b772-d60c0c3be05c 13811-648 HUMAN OTC DRUG Meclizine HCl MECLIZINE HYDROCHLORIDE CHEWABLE TABLETS TABLET, CHEWABLE ORAL 20130923 OTC MONOGRAPH FINAL part336 Trigen Laboratories, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 13811-656_2938a5e2-8ed7-4b45-b47e-f41482ac40e1 13811-656 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate SUSPENSION ORAL; RECTAL 20150410 ANDA ANDA206815 Trigen Laboratories, LLC SODIUM POLYSTYRENE SULFONATE 4.1 meq/g N 20181231 13811-658_2dbe9396-f205-4443-93b1-d69e9531bd7f 13811-658 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150822 ANDA ANDA204519 Trigen Laboratories, LLC CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 13811-659_2dbe9396-f205-4443-93b1-d69e9531bd7f 13811-659 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150822 ANDA ANDA204519 Trigen Laboratories, LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 13811-660_2dbe9396-f205-4443-93b1-d69e9531bd7f 13811-660 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150822 ANDA ANDA204519 Trigen Laboratories, LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 13811-661_2dbe9396-f205-4443-93b1-d69e9531bd7f 13811-661 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150822 ANDA ANDA204519 Trigen Laboratories, LLC CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 13811-669_18fe1a05-215b-445b-b309-580660325a43 13811-669 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 Trigen Laboratories, LLC METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13811-670_18fe1a05-215b-445b-b309-580660325a43 13811-670 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 Trigen Laboratories, LLC METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13811-671_18fe1a05-215b-445b-b309-580660325a43 13811-671 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 Trigen Laboratories, LLC METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 100; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 13811-677_90bcf9c0-f3ca-4634-a6f7-d24f134aaa14 13811-677 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20110506 ANDA ANDA091369 Trigen Laboratories, LLC LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] N 20181231 13811-678_90bcf9c0-f3ca-4634-a6f7-d24f134aaa14 13811-678 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20110506 ANDA ANDA091369 Trigen Laboratories, LLC LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] N 20181231 13811-679_f07ffa73-6b9b-44fe-873f-88aba0bf2325 13811-679 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Trigen Laboratories, LLC ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 13811-680_f07ffa73-6b9b-44fe-873f-88aba0bf2325 13811-680 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Trigen Laboratories, LLC ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 13811-681_f07ffa73-6b9b-44fe-873f-88aba0bf2325 13811-681 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Trigen Laboratories, LLC ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 13811-682_f07ffa73-6b9b-44fe-873f-88aba0bf2325 13811-682 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Trigen Laboratories, LLC ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 13811-683_f07ffa73-6b9b-44fe-873f-88aba0bf2325 13811-683 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Trigen Laboratories, LLC ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 13811-684_f07ffa73-6b9b-44fe-873f-88aba0bf2325 13811-684 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Trigen Laboratories, LLC ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 13811-689_821b8fd5-556d-4bac-a975-3038357688ee 13811-689 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Extended-Release tramadol hydrochloride CAPSULE ORAL 20150622 NDA AUTHORIZED GENERIC NDA022370 Trigen Laboratories, LLC TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 13811-690_821b8fd5-556d-4bac-a975-3038357688ee 13811-690 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Extended-Release tramadol hydrochloride CAPSULE ORAL 20150622 NDA AUTHORIZED GENERIC NDA022370 Trigen Laboratories, LLC TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 13811-691_821b8fd5-556d-4bac-a975-3038357688ee 13811-691 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Extended-Release tramadol hydrochloride CAPSULE ORAL 20150622 NDA AUTHORIZED GENERIC NDA022370 Trigen Laboratories, LLC TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 13811-692_2dba4ce6-8bae-4e15-85ef-9eb1b90b2d3b 13811-692 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET, ORALLY DISINTEGRATING ORAL 20150521 ANDA ANDA202102 Trigen Laboratories, LLC ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 13811-693_2dba4ce6-8bae-4e15-85ef-9eb1b90b2d3b 13811-693 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET, ORALLY DISINTEGRATING ORAL 20150521 ANDA ANDA202102 Trigen Laboratories, LLC ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 13811-694_5cd0a23f-b65e-46a8-9394-0d6296c40ca1 13811-694 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20170222 ANDA ANDA207555 Trigen Laboratories CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 13811-701_37b2453d-c089-573d-e054-00144ff88e88 13811-701 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160915 ANDA ANDA205629 Trigen Laboratories, LLC HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13811-702_37b2453d-c089-573d-e054-00144ff88e88 13811-702 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160915 ANDA ANDA205629 Trigen Laboratories, LLC HYDROMORPHONE HYDROCHLORIDE 12 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13811-703_37b2453d-c089-573d-e054-00144ff88e88 13811-703 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160915 ANDA ANDA205629 Trigen Laboratories, LLC HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13811-704_37b2453d-c089-573d-e054-00144ff88e88 13811-704 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160915 ANDA ANDA205629 Trigen Laboratories, LLC HYDROMORPHONE HYDROCHLORIDE 32 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13811-705_e1be578c-5a23-4f51-ad3a-c0835561c184 13811-705 HUMAN PRESCRIPTION DRUG SODIUM PHENYLACETATE and SODIUM BENZOATE sodium phenylacetate and sodium benzoate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160224 ANDA ANDA207096 Trigen Laboratories, LLC SODIUM PHENYLACETATE; SODIUM BENZOATE 100; 100 mg/mL; mg/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 13811-706_5e805339-0ca3-1aa2-e053-2991aa0ae684 13811-706 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20170814 ANDA ANDA205327 Trigen Laboratories, LLC METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 13811-707_5e805339-0ca3-1aa2-e053-2991aa0ae684 13811-707 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20170814 ANDA ANDA205327 Trigen Laboratories, LLC METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 13811-708_5e805339-0ca3-1aa2-e053-2991aa0ae684 13811-708 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20170814 ANDA ANDA205327 Trigen Laboratories, LLC METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 13811-709_5e805339-0ca3-1aa2-e053-2991aa0ae684 13811-709 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20170814 ANDA ANDA205327 Trigen Laboratories, LLC METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 13811-712_5d167b1f-e66d-353b-e053-2991aa0a3d1d 13811-712 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA AUTHORIZED GENERIC NDA022104 Trigen Laboratories, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13811-713_5d167b1f-e66d-353b-e053-2991aa0a3d1d 13811-713 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA AUTHORIZED GENERIC NDA022104 Trigen Laboratories, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13811-714_5d167b1f-e66d-353b-e053-2991aa0a3d1d 13811-714 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA AUTHORIZED GENERIC NDA022104 Trigen Laboratories, LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13811-715_5d167b1f-e66d-353b-e053-2991aa0a3d1d 13811-715 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA AUTHORIZED GENERIC NDA022104 Trigen Laboratories, LLC VENLAFAXINE HYDROCHLORIDE 225 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 13811-717_60b6456f-2293-7ea4-e053-2a91aa0a9b37 13811-717 HUMAN PRESCRIPTION DRUG chlorzoxazone chlorzoxazone TABLET ORAL 20180101 ANDA ANDA040861 Trigen Laboratories, LLC CHLORZOXAZONE 375 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 13811-718_60b6456f-2293-7ea4-e053-2a91aa0a9b37 13811-718 HUMAN PRESCRIPTION DRUG chlorzoxazone chlorzoxazone TABLET ORAL 20180101 ANDA ANDA040861 Trigen Laboratories, LLC CHLORZOXAZONE 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 13826-001_831df078-f36f-4ac5-a747-26b6da245cea 13826-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850101 NDA NDA205865 Four Corners Welding OXYGEN 990 mL/L N 20181231 13845-1200_e9dc169f-0f00-411c-9c3e-4ea7b9e85392 13845-1200 HUMAN PRESCRIPTION DRUG SEROMYCIN CYCLOSERINE CAPSULE ORAL 20090301 ANDA ANDA060593 Purdue GMP Center LLC dba The Chao Center CYCLOSERINE 250 mg/250mg N 20181231 13845-1201_af0b4266-147c-4942-aaf9-4d5b8905207c 13845-1201 HUMAN PRESCRIPTION DRUG CYCLOSERINE CYCLOSERINE CAPSULE ORAL 20090301 ANDA ANDA060593 Purdue GMP Center LLC dba The Chao Center CYCLOSERINE 250 mg/250mg N 20181231 13845-1202_b5304a23-d1d2-4c24-a56d-2b424d60bb52 13845-1202 HUMAN PRESCRIPTION DRUG Cycloserine Cycloserine CAPSULE ORAL 19520129 ANDA ANDA060593 Purdue GMP Center LLC CYCLOSERINE 250 1/1 N 20181231 13913-001_916845b4-dd49-4c20-a5e9-9a792a788963 13913-001 HUMAN PRESCRIPTION DRUG Proquin XR ciprofloxacin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051001 NDA NDA021744 Depomed, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 13913-002_121fc3e0-33fe-41af-a7ef-e6b54ee60ef6 13913-002 HUMAN PRESCRIPTION DRUG Glumetza metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060801 NDA NDA021748 Depomed, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 13913-003_121fc3e0-33fe-41af-a7ef-e6b54ee60ef6 13913-003 HUMAN PRESCRIPTION DRUG Glumetza metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080617 NDA NDA021748 Depomed, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 13913-004_56c270b4-fccf-41dc-b69f-b3910033999a 13913-004 HUMAN PRESCRIPTION DRUG Gralise gabapentin TABLET, FILM COATED ORAL 20110128 NDA NDA022544 Depomed, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 13913-005_56c270b4-fccf-41dc-b69f-b3910033999a 13913-005 HUMAN PRESCRIPTION DRUG Gralise gabapentin TABLET, FILM COATED ORAL 20110128 NDA NDA022544 Depomed, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 13913-006_56c270b4-fccf-41dc-b69f-b3910033999a 13913-006 HUMAN PRESCRIPTION DRUG Gralise Starter Pack gabapentin KIT 20110128 NDA NDA022544 Depomed, Inc. N 20181231 13913-008_e7043307-b56a-43cb-b337-877676623865 13913-008 HUMAN PRESCRIPTION DRUG ZIPSOR diclofenac potassium CAPSULE, LIQUID FILLED ORAL 20090616 NDA NDA022202 Depomed, Inc. DICLOFENAC POTASSIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 13913-009_c2b4b455-fd85-4767-baee-4d068f08e4e7 13913-009 HUMAN PRESCRIPTION DRUG Lazanda fentanyl citrate SPRAY NASAL 20111017 NDA NDA022569 Depomed, Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13913-010_c2b4b455-fd85-4767-baee-4d068f08e4e7 13913-010 HUMAN PRESCRIPTION DRUG Lazanda fentanyl citrate SPRAY NASAL 20111017 NDA NDA022569 Depomed, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13913-011_0a369ac4-c2c2-4746-a578-61c992aba209 13913-011 HUMAN PRESCRIPTION DRUG Cambia diclofenac potassium POWDER, FOR SOLUTION ORAL 20100420 NDA NDA022165 Depomed, Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 13913-012_61bcab81-6b31-472f-93ae-73f6e1c59ae0 13913-012 HUMAN PRESCRIPTION DRUG Cambia diclofenac potassium POWDER, FOR SOLUTION ORAL 20160310 NDA NDA022165 Depomed, Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 13913-013_c2b4b455-fd85-4767-baee-4d068f08e4e7 13913-013 HUMAN PRESCRIPTION DRUG Lazanda fentanyl citrate SPRAY NASAL 20160101 NDA NDA022569 Depomed, Inc. FENTANYL CITRATE 300 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 13925-107_d21a1fdb-7111-4038-975f-f93de44d63a7 13925-107 HUMAN PRESCRIPTION DRUG Methenamine Mandelate Methenamine Mandelate TABLET, FILM COATED ORAL 20100201 UNAPPROVED DRUG OTHER Seton Pharmaceuticals METHENAMINE MANDELATE 1000 mg/1 N 20181231 13925-116_f6e296c6-2c66-4306-870e-b5a5b25296b9 13925-116 HUMAN PRESCRIPTION DRUG Se-Natal 19 .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium TABLET ORAL 20090701 UNAPPROVED DRUG OTHER Seton Pharmaceuticals .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; DOCUSATE SODIUM 1000; 100; 400; 30; 3; 3; 15; 20; 1; 12; 7; 200; 29; 20; 25 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 13925-117_c1fbc523-f64b-487e-832b-5ebdb84321b1 13925-117 HUMAN PRESCRIPTION DRUG Se-Natal 19 Chewable Vitamins and Minerals TABLET, CHEWABLE ORAL 20090701 UNAPPROVED DRUG OTHER Seton Pharmaceuticals FOLIC ACID; BETA CAROTENE; CALCIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE 1; 1000; 100; 400; 30; 3; 3; 15; 20; 12; 7; 200; 29; 20 mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 13925-118_56e912df-3a49-4405-8df1-7b80d12bd920 13925-118 HUMAN PRESCRIPTION DRUG Se-Tan PLUS MULTIVITAMIN/MINERAL CAPSULE, GELATIN COATED ORAL 20091001 UNAPPROVED DRUG OTHER Seton Pharmaceuticals FERROUS FUMARATE; IRON DEXTRAN; SODIUM ASCORBATE; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; CALCIUM PANTOTHENATE; ZINC SULFATE; MANGANESE SULFATE; CUPRIC SULFATE 162; 115.2; 200; 10; 6; 5; 15; 1; 30; 10; 18.2; 1.3; .8 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] N 20181231 13925-157_ab11e4ad-696d-453d-99dd-2b1f020d5285 13925-157 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate CREAM RECTAL 20110617 UNAPPROVED DRUG OTHER Seton Pharmaceuticals LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 30; 5 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 13925-159_8451610e-eed9-4857-9171-938d00e307cf 13925-159 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride CREAM TOPICAL 20110620 UNAPPROVED DRUG OTHER Seton Pharmaceuticals LIDOCAINE HYDROCHLORIDE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 13925-160_28229a40-b47c-4ed0-b97f-3f60d8e9bdbc 13925-160 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate CREAM TOPICAL 20110617 UNAPPROVED DRUG OTHER Seton Pharmaceuticals LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 30; 5 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 13925-161_500f0fb5-ba0d-4c3d-9ee3-8b30c5bfddc1 13925-161 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide and Sulfur Sodium Sulfacetamide and Sulfur SOLUTION TOPICAL 20110527 UNAPPROVED DRUG OTHER Seton Pharmaceuticals SULFACETAMIDE; SULFUR 100; 50 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 13925-163_4fae3318-79a9-46c3-bc9b-8adef467749c 13925-163 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate CREAM RECTAL 20110617 UNAPPROVED DRUG OTHER Seton Pharmaceuticals LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 30; 10 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 13925-164_8c41328e-4474-459a-878b-5592f70256bd 13925-164 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate GEL RECTAL 20110617 UNAPPROVED DRUG OTHER Seton Pharmaceuticals LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 30; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 13925-165_be20cf9d-5d76-4f29-a07b-3cd22aedffb9 13925-165 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate CREAM RECTAL 20110617 UNAPPROVED DRUG OTHER Seton Pharmaceuticals LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 30; 5 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 13925-166_26e30a1b-7602-45d8-912f-d61c959e4fca 13925-166 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20131018 NDA NDA019157 Seton Pharmaceuticals, LLC PREDNISOLONE SODIUM PHOSPHATE 5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 13925-174_186f95ea-62bf-4bc5-81e1-bababbaa7bcd 13925-174 HUMAN PRESCRIPTION DRUG Iodoquinol 1% - Hydrocortisone Acetate 2% - Aloe Polysaccharides 1% Iodoquinol 1% - Hydrocortisone Acetate 2% - Aloe Polysaccharides 1% GEL TOPICAL 20170914 UNAPPROVED DRUG OTHER Seton Pharmaceuticals IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF POLYSACCHARIDES 10; 20; 10 mg/g; mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 13925-504_8cb7a26d-fe47-4526-b65b-6202736ad398 13925-504 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20160304 ANDA ANDA086841 Seton Pharmaceuticals DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 13925-505_8cb7a26d-fe47-4526-b65b-6202736ad398 13925-505 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20160310 ANDA ANDA086842 Seton Pharmaceuticals DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 13925-506_a25d66f9-01c4-4520-b134-b1ea7657838a 13925-506 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide OIL TOPICAL 20130820 NDA AUTHORIZED GENERIC NDA019452 Seton Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 13925-507_16e3bb49-35e7-40b9-9004-58f17a71dea6 13925-507 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide OIL TOPICAL 20130801 NDA AUTHORIZED GENERIC NDA019452 Seton Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 13925-508_2c23c6de-fb0a-4146-828a-2f96aef80001 13925-508 HUMAN PRESCRIPTION DRUG Fluocinolone acetonide 0.01% fluocinolone acetonide OIL AURICULAR (OTIC) 20130801 NDA AUTHORIZED GENERIC NDA019452 Seton Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 13925-515_6e8bfef5-266c-480e-a2c2-0ec29db54cce 13925-515 HUMAN PRESCRIPTION DRUG Pentamidine Isethionate Pentamidine Isethionate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130901 ANDA ANDA206666 Seton Pharmaceuticals PENTAMIDINE ISETHIONATE 300 mg/300mg Antiprotozoal [EPC] N 20181231 13925-523_7f99c736-ed7d-4c16-aa22-879cbdac11f1 13925-523 HUMAN PRESCRIPTION DRUG AZACITIDINE azacitidine for INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20170517 ANDA ANDA207518 Seton Pharmaceuticals AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 13985-014_8d55dfcf-788d-4504-aebd-afcc98c81345 13985-014 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 19940725 ANDA ANDA064063 MWI/VetOne NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 13985-016_10195234-e8c4-455a-9e27-0333f454ea3f 13985-016 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 19951030 ANDA ANDA064068 MWI/VetOne NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE 3.5; 10000; 400; 10 mg/g; [USP'U]/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 13985-025_dbcab023-8a71-4c66-ac6b-b98b20a493f9 13985-025 HUMAN PRESCRIPTION DRUG PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS OPHTHALMIC 19940729 ANDA ANDA040070 MWI/VetOne PREDNISOLONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 13985-028_01e58ae0-cdcf-4c1f-bfb9-9d0fc3ebd002 13985-028 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 MWI/VetOne NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 13985-529_06caa424-56ef-4b31-a226-14db9ee4a457 13985-529 HUMAN OTC DRUG Veti-Foam Benzethonium Chloride LIQUID TOPICAL 20100726 OTC MONOGRAPH NOT FINAL part333A MWI/Vet One BENZETHONIUM CHLORIDE 2 g/L E 20171231 13985-600_eac9a17f-4a0a-4166-b39f-1bd20f3cb2f9 13985-600 HUMAN OTC DRUG Artificial Tears Mineral Oil and Petrolatum OINTMENT OPHTHALMIC 20150323 OTC MONOGRAPH FINAL part349 MWI MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g N 20181231 13985-601_7e0088a6-94c5-4f42-9033-27bc12df8269 13985-601 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20150323 OTC MONOGRAPH FINAL part349 MWI POLYVINYL ALCOHOL 14 mg/mL N 20181231 13985-602_30ff9c32-0f8e-4097-b8f2-7a5f6e5c2d60 13985-602 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20150327 ANDA ANDA076407 MWI OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 13985-603_00fbf3bb-1d6f-427d-8ea3-f5ec99d4f434 13985-603 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate OINTMENT OPHTHALMIC 20150323 ANDA ANDA064163 MWI GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 13985-604_06710583-a10e-444d-bc39-f2ee433c45c3 13985-604 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC 20150327 ANDA ANDA064096 MWI TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 13985-605_e6bcdf9f-639c-4bfc-9e78-66c2324c9971 13985-605 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20150323 ANDA ANDA064030 MWI ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 13985-606_dde94271-817f-4e0f-86e6-b138421201b3 13985-606 HUMAN PRESCRIPTION DRUG Atropine Atropine Sulfate SOLUTION/ DROPS OPHTHALMIC 20150323 NDA NDA206289 MWI ATROPINE SULFATE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 13985-607_aa86014c-8e54-4979-99b3-194bac332cdd 13985-607 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 20150323 ANDA ANDA065088 MWI NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] N 20181231 13985-608_de66f743-f823-4181-a181-c3e4a2ca97dc 13985-608 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 20150323 ANDA ANDA065213 MWI NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE 3.5; 10000; 400; 10 mg/g; [USP'U]/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 13985-609_9555d4b2-a2c6-4d80-bd15-03205a9741ad 13985-609 HUMAN OTC DRUG Eyewash Water SOLUTION OPHTHALMIC 20150223 NDA NDA022305 MWI WATER 929 g/946mL E 20171231 13985-610_8066602b-7984-46cc-87b9-660e0addcda9 13985-610 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION/ DROPS OPHTHALMIC 20150408 ANDA ANDA090887 MWI LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 13985-611_0b2e3681-4ed3-44b6-9087-1ec7ccfe160c 13985-611 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20150327 ANDA ANDA040277 MWI PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] N 20181231 13985-706_9eb654f4-48c2-4af4-b676-08f77643aafd 13985-706 HUMAN PRESCRIPTION DRUG Vet one Silver Nitrate Applicator STICK TOPICAL 20100101 UNAPPROVED DRUG OTHER MWI Veterinary Supply SILVER NITRATE; POTASSIUM NITRATE 38.21; 12.74 mg/1; mg/1 N 20181231 13985-743_f27222f8-5c7c-4ba6-848e-e96c3ac7ea87 13985-743 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19931129 ANDA ANDA064052 MWI TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 13985-744_d178cf8f-5bce-43f8-b436-cd963b428bee 13985-744 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 19940725 ANDA ANDA064063 MWI NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/g; [USP'U]/g; mg/g Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 13985-745_724ddfb3-be4c-4da4-bd96-4193981c6cde 13985-745 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 19951030 ANDA ANDA064068 MWI NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE 3.5; 10000; 400; 10 mg/g; [USP'U]/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 13985-746_40e69b46-7ae2-443a-85c8-ebd7693a04ce 13985-746 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 MWI NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] N 20181231 13992-001_a3708c12-8157-4cbe-a957-ba774d15a6fc 13992-001 HUMAN OTC DRUG Colic Calm Aloe Socotrina, Carbo Vegetabilis, Carum Carvi, Chamomilla, Foeniculum Vulgare, Melissa Officinalis, Mentha Piperita, Prunus Spinosa, Zingiber Officinale LIQUID ORAL 20070108 UNAPPROVED HOMEOPATHIC TJL Enterprises Inc. ALOE; ACTIVATED CHARCOAL; CARAWAY OIL; CHAMOMILE; FENNEL SEED; MELISSA OFFICINALIS; MENTHA PIPERITA; PRUNUS SPINOSA FLOWER BUD; GINGER 5; 1; 5; 5; 5; 5; 5; 5; 5 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 13992-002_5ec08922-d24f-4dcb-bce5-f155caf813c0 13992-002 HUMAN OTC DRUG Colic Calm Plus Aloe, Asafoetida, Carbo Vegetabilis, Carum Carvi, Chamomilla, Cinchona Officinalis, Foeniculum Vulgare, Magnesia Phosphorica, Melissa Officinalis, Mentha Piperita, Prunus Spinosa, Zingiber Officinale LIQUID ORAL 20161213 UNAPPROVED HOMEOPATHIC TJL Enterprises Inc. ALOE; FERULA ASSA-FOETIDA RESIN; ACTIVATED CHARCOAL; CARAWAY OIL; CHAMOMILE; CINCHONA OFFICINALIS BARK; FENNEL SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MELISSA OFFICINALIS; MENTHA PIPERITA; PRUNUS SPINOSA FLOWER BUD; GINGER 8; 3; 1; 3; 3; 3; 3; 8; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 13992-005_c2e277e0-d49c-45c1-b879-1d85c6dcbe01 13992-005 HUMAN OTC DRUG Tummy Calm Aloe, Carbo Vegetabilis, Chamomilla, Lycopodium Clavatum, Nux Moschata, Passiflora Incarnata, Raphanus Sativus, Sarsaparilla, Zingiber Officinale LIQUID ORAL 20151120 UNAPPROVED HOMEOPATHIC TJL Enterprises Inc. ALOE; ACTIVATED CHARCOAL; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; NUTMEG; PASSIFLORA INCARNATA FLOWERING TOP; RADISH; SMILAX REGELII ROOT; GINGER 3; 1; 3; 3; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 13992-008_6b91d5bc-96b0-49ed-a508-7ced2474f7f8 13992-008 HUMAN OTC DRUG Colic Calm Aloe, Carbo Vegetabilis, Carum Carvi, Chamomilla, Foeniculum Vulgare, Melissa Officinalis, Mentha Piperita, Prunus Spinosa, Zingiber Officinale LIQUID ORAL 20170104 UNAPPROVED HOMEOPATHIC TJL Enterprises Inc. ALOE; ACTIVATED CHARCOAL; CARAWAY SEED; CHAMOMILE; FENNEL SEED; MELISSA OFFICINALIS; MENTHA PIPERITA; PRUNUS SPINOSA FLOWER BUD; GINGER 3; 1; 3; 3; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 13992-009_df61cff7-49e3-432d-a806-76f4ff3a017f 13992-009 HUMAN OTC DRUG Colic Calm Carbo Vegetabilis, Carum Carvi, Chamomilla, Foeniculum Vulgare, Melissa Officinalis, Mentha Piperita, Prunus Spinosa, Zingiber Officinale LIQUID ORAL 20170314 UNAPPROVED HOMEOPATHIC TJL Enterprises Inc. ACTIVATED CHARCOAL; CARAWAY SEED; CHAMOMILE; FENNEL SEED; MELISSA OFFICINALIS; MENTHA PIPERITA; PRUNUS SPINOSA FLOWER BUD; GINGER 1; 3; 3; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 14051-221_cb21905c-653f-47a4-81c6-ff51f9c0e68f 14051-221 HUMAN OTC DRUG Care ALCOHOL GEL TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part333E Top Chemical Co., Inc. ALCOHOL .7 mL/mL N 20181231 14060-002_5f8cf513-110b-4858-98d9-d46aa71cb064 14060-002 HUMAN PRESCRIPTION DRUG BeeGentle Topical Anesthetic benzocaine GEL TOPICAL 20100901 UNAPPROVED DRUG OTHER CAO Group, Inc. BENZOCAINE 210 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 14060-003_26909161-a24d-4af7-8613-98499621d219 14060-003 HUMAN PRESCRIPTION DRUG SheerDesenZ Desensitizing Treatment potassium nitrate FILM DENTAL 20100901 UNAPPROVED DRUG OTHER CAO Group, Inc. POTASSIUM NITRATE 12 mg/1 E 20171231 14060-005_5792739d-dbf0-494c-aacc-d4cce115ff1e 14060-005 HUMAN PRESCRIPTION DRUG SheerFluorX Fluoride Treatment sodium fluoride FILM DENTAL 20100901 UNAPPROVED DRUG OTHER CAO Group, Inc. SODIUM FLUORIDE 20 mg/1 E 20171231 14060-006_2d80d192-c627-4b95-bb86-dcb5949e6cdc 14060-006 HUMAN PRESCRIPTION DRUG Sheer FluorX PEDO Fluoride Treatment sodium fluoride FILM DENTAL 20110415 UNAPPROVED DRUG OTHER CAO Group, Inc. SODIUM FLUORIDE 20 mg/1 E 20171231 14060-010_0b2fffc7-c223-49c6-9b90-541cedff754e 14060-010 HUMAN PRESCRIPTION DRUG FastStat Topical Hemostat ferric sulfate GEL INTRAGINGIVAL 20100901 UNAPPROVED DRUG OTHER CAO Group, Inc. FERRIC SULFATE 142 mg/g Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] E 20171231 14208-003_5085c73c-8754-4d8a-9024-0c679911ca3a 14208-003 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20170101 NDA NDA205766 California Tool & Welding Supply, LLC NITROGEN 99 L/100L N 20191231 14208-532_4df273df-e62f-4732-a320-bc8011d3fea3 14208-532 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19760101 NDA NDA205767 California Tool and Welding Supply, LLC OXYGEN 99 L/100L N 20191231 14209-585_8d759134-8e80-4cb6-819a-cb0e3dee4cfd 14209-585 HUMAN OTC DRUG Germ Safe ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Original 7, Inc. ALCOHOL .7 mL/mL E 20171231 14209-855_4273876b-6850-4d78-9b44-7299890ed2b1 14209-855 HUMAN OTC DRUG Germ Safe ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333E Original 7, Inc. ALCOHOL .62 mL/mL E 20171231 14214-0123_a5ceacd0-05a2-44a4-a5aa-5dc0e14a8bdf 14214-0123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Leading Respiratory Service Inc. OXYGEN 99 L/100L E 20171231 14222-0000_60ef8923-e10e-4197-e053-2a91aa0acf6e 14222-0000 HUMAN OTC DRUG RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE CREAM TOPICAL 20130603 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields TITANIUM DIOXIDE; ZINC OXIDE 20; 120 mg/mL; mg/mL N 20181231 14222-0001_60f04e6e-4140-c25a-e053-2a91aa0a3291 14222-0001 HUMAN OTC DRUG RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 70; 40; 17 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 14222-0420_60f024da-ab18-7f7a-e053-2991aa0a6c94 14222-0420 HUMAN OTC DRUG RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 14222-0425_0f418e13-4a0e-4ddb-ab68-260a7e6faf22 14222-0425 HUMAN OTC DRUG Rodan and Fields ESSENTIALS Lip Shield Broad Spectrum SPF 25 Avobenzone, Homosalate, Octisalate, Octocrylene STICK TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 8; 5; 2.2 g/100g; g/100g; g/100g; g/100g N 20181231 14222-1005_90685638-eb8d-4425-8322-1ddca75330fe 14222-1005 HUMAN OTC DRUG SOOTHE Sensitive Skin Treatment Allantoin, Dimethicone LOTION TOPICAL 20170601 OTC MONOGRAPH FINAL part347 Rodan & Fields ALLANTOIN; DIMETHICONE .5; 2.9 g/100mL; g/100mL N 20191231 14222-1010_bdbc4300-01ff-4cd6-b492-3c15d3f3ce8f 14222-1010 HUMAN OTC DRUG SOOTHE Regimen for Sensitive Skin Allantoin, Dimethicone, Titanium Dioxide, Zinc Oxide KIT TOPICAL 20170601 UNAPPROVED DRUG OTHER Rodan & Fields N 20181231 14222-1015_2cfa4b92-abf3-4d13-ae9f-56e6cc1e9d3d 14222-1015 HUMAN OTC DRUG SOOTHE Regimen for Sensitive Skin Travel Size Allantoin, Dimethicone, Titanium Dioxide, Zinc Oxide KIT TOPICAL 20170724 UNAPPROVED DRUG OTHER Rodan & Fields N 20191231 14222-1615_c6954fc7-c178-41e7-895d-5b71f8f9b657 14222-1615 HUMAN OTC DRUG Skin Lightening Rodan Fields HYDROQUINONE LIQUID TOPICAL 20110606 OTC MONOGRAPH NOT FINAL part358A Rodan & Fields, LLC. HYDROQUINONE 2 mL/100mL N 20181231 14222-2000_68438a63-4972-4752-9322-27e597047354 14222-2000 HUMAN OTC DRUG Unblemish Benzoyl Peroxide LOTION TOPICAL 20140601 OTC MONOGRAPH FINAL part333D Rodan & Fields, LLC BENZOYL PEROXIDE 50 mg/mL E 20171231 14222-2003_13cef1df-4845-4601-9939-9816d37879ac 14222-2003 HUMAN OTC DRUG Soothe Rodan Fields HYDROCORTISONE LOTION TOPICAL 20110607 OTC MONOGRAPH NOT FINAL part348 Rodan & Fields, LLC. HYDROCORTISONE 1 mL/100mL N 20181231 14222-2020_0351e8dd-ca76-4a5a-83d0-b8e423effd07 14222-2020 HUMAN OTC DRUG Rodan Fields UNBLEMISH Regimen for Acne, Blemishes and Breakouts Sulfur, Benzoyl Peroxide, Titanium Dioxide, Zinc Oxide KIT TOPICAL 20170601 UNAPPROVED DRUG OTHER Rodan & Fields, LLC. N 20181231 14222-2022_44be628e-fe1d-4061-a3b2-5f1b72fb383b 14222-2022 HUMAN OTC DRUG UVA/UVB SPF 15 Rodan and Fields Octinoxate, Zinc Oxide LOTION TOPICAL 20110603 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields LLC. OCTINOXATE; ZINC OXIDE 7.5; 3.4 mL/100mL; mL/100mL N 20181231 14222-2025_c161f48d-345d-4e36-bc4d-b616ffaf8aae 14222-2025 HUMAN OTC DRUG UNBLEMISH Regimen for Acne, Blemishes and Breakouts Travel Size Sulfur, Benzoyl Peroxide, Titanium Dioxide, Zinc Oxide KIT TOPICAL 20170724 UNAPPROVED DRUG OTHER Rodan & Fields, LLC. N 20181231 14222-2050_d6a87ab5-3dea-459a-9c53-f02ce0dc0c44 14222-2050 HUMAN OTC DRUG Acne Treatment Sulfur Wash Rodan and Field SULFUR LIQUID TOPICAL 20110608 OTC MONOGRAPH FINAL part358H Rodan & Fields, LLC. SULFUR 3 g/100mL E 20171231 14222-2060_d8d1087f-b283-4aed-a5da-803fdcda87ac 14222-2060 HUMAN OTC DRUG UNBLEMISH Control Broad Spectrum SPF 20 Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20171006 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields TITANIUM DIOXIDE; ZINC OXIDE .7; 4.75 g/100mL; g/100mL N 20191231 14222-2240_4af7b13a-31d6-48c9-a58e-ed28b208195b 14222-2240 HUMAN OTC DRUG Rodan and Fields Redefine Age Shield Hand Shield Balm SPF30 Octisalate, Avobenzone, Homosalate, Octocrylene EMULSION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Rodan and Fields OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE 5; 3; 2.5; 2.7 g/100g; g/100g; g/100g; g/100g N 20181231 14222-2250_6cdf9159-a740-45c3-b305-530e93175ea8 14222-2250 HUMAN OTC DRUG Rodan and Fields Redefine AM SPF 30 Octisalate, Avobenzone, Octocrylene, Homosalate CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 Rodan and Fields OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE 5; 3; 2.7; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 14222-2260_d04660f8-b67a-4327-ad9d-8cf376f3e59b 14222-2260 HUMAN OTC DRUG Rodan and Fields REDEFINE Regimen for the Appearance of Lines, Pores and Loss of Firmness Octocrylene, Avobenzone, Octisalate, Homosalate KIT TOPICAL 20160310 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields E 20171231 14222-2265_7345cbcf-2bb2-435a-b9fb-3fde22df92b8 14222-2265 HUMAN OTC DRUG REDEFINE Regimen for the Appearance of Lines, Pores and Loss of Firmness Travel Size Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20170724 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 2.5; 5; 2.7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 14222-429_d06c39b2-0fa8-4efb-b067-6f56a03201d7 14222-429 HUMAN OTC DRUG Rodan and Fields Skin Lightening Treatment Hydroquinone CREAM TOPICAL 20110607 OTC MONOGRAPH NOT FINAL part358A Rodan & Fields LLC. HYDROQUINONE 2 mL/100mL E 20171231 14222-5000_7020faca-2eb2-4732-971d-153e71eac89b 14222-5000 HUMAN OTC DRUG Skin Lightening Accelerator Pack Hydroquinone KIT 20150819 OTC MONOGRAPH NOT FINAL part358A Rodan & Fields, LLC. N 20181231 14222-5020_2313418e-2bf8-4236-8d59-74349d8e9d04 14222-5020 HUMAN OTC DRUG REVERSE Regimen for the Appearance of Skin Dullness, Discoloration and Uneven Skin Tone Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 14222-5025_d569d359-6830-4a2d-8cd9-6267a7b40cd1 14222-5025 HUMAN OTC DRUG REVERSE Regimen for the Appearance of Skin Dullness, Discoloration and Uneven Skin Tone Travel Size Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20170724 OTC MONOGRAPH NOT FINAL part352 Rodan & Fields AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 14222-5030_812c31b4-478b-42f9-98fd-1b0d707c9da3 14222-5030 HUMAN OTC DRUG REVERSE Lightening Regimen for the Appearance of Stubborn Dark Marks, Patches and Age Spots Hydroquinone, Avobenzone, Homosalate, Octisalate, Octocrylene KIT TOPICAL 20170601 UNAPPROVED DRUG OTHER Rodan & Fields, LLC. N 20181231 14222-5035_ae048d7b-b135-4117-bb25-218948472aea 14222-5035 HUMAN OTC DRUG REVERS Lightening Regimen for the Appearance of Stubborn Dark Marks, Patches and Age Spots Travel Size Hydroquinone, Avobenzone, Homosalate, Octisalate, Octocrylene KIT TOPICAL 20170724 UNAPPROVED DRUG OTHER Rodan & Fields N 20191231 14222-6000_33d0d813-d1ee-4389-a471-4998f56e5832 14222-6000 HUMAN OTC DRUG BEYOND THE SHAVE For Men Sulfur, Allantoin, Dimethicone, Avobenzone, Homosalate, Octisalate, Octocrylene KIT TOPICAL 20170601 UNAPPROVED DRUG OTHER Rodan & Fields N 20191231 14268-017_6191d2ea-6529-e9f0-e053-2991aa0a5fa1 14268-017 HUMAN OTC DRUG Dr. Perrys Day Thyme SPF 20 Broad Spectrum Sunscreen ZINC OXIDE GEL TOPICAL 20160404 OTC MONOGRAPH NOT FINAL part352 Englewood Lab, Inc. ZINC OXIDE 100 mg/mL N 20181231 14319-3118_a4f660cb-f504-4f9c-9c3b-5cb4faf0d07a 14319-3118 HUMAN OTC DRUG Plaster MandAHerbalPlaster Menthol PATCH TOPICAL 20050425 OTC MONOGRAPH NOT FINAL part348 Dah Wei Chem & Pharm Co., Ltd. MENTHOL; METHYL SALICYLATE; CAMPHOR (SYNTHETIC); MYRRH; SESAME OIL 1.2; 1.5; .24; .9; 3 g/30g; g/30g; g/30g; g/30g; g/30g E 20171231 14324-001_60dc955d-c512-2b9b-e053-2991aa0a70ff 14324-001 HUMAN OTC DRUG Adaptasun Sun Care Face SPF 15 OCTINOXATE, AVOBENZONE CREAM TOPICAL 20151004 OTC MONOGRAPH NOT FINAL part352 NAOS OCTINOXATE; AVOBENZONE 40; 25 mg/mL; mg/mL N 20181231 14324-002_60dc8c6d-6c18-3049-e053-2991aa0af344 14324-002 HUMAN OTC DRUG Adaptasun Sun Care Sea and Tropics Face SPF 25 OCTINOXATE, AVOBENZONE CREAM TOPICAL 20151004 OTC MONOGRAPH NOT FINAL part352 NAOS OCTINOXATE; AVOBENZONE 60; 25.4 mg/mL; mg/mL N 20181231 14324-010_64431eff-e7a7-2a22-e053-2991aa0aecf9 14324-010 HUMAN OTC DRUG ADAPTASUN SUN CARE BODY SPF 15 OCTINOXATE, AVOBENZONE LOTION TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 NAOS OCTINOXATE; AVOBENZONE 45; 25 mg/mL; mg/mL N 20191231 14324-011_64431eff-e7a9-2a22-e053-2991aa0aecf9 14324-011 HUMAN OTC DRUG UV PROTECT FACE SPF 50 ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 NAOS ZINC OXIDE; TITANIUM DIOXIDE 200; 882 mg/mL; mg/mL N 20191231 14324-012_64434256-5f5f-3a23-e053-2991aa0afee2 14324-012 HUMAN OTC DRUG NO SUN FACE SPF 50 ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 NAOS ZINC OXIDE; TITANIUM DIOXIDE 199; 90 mg/mL; mg/mL N 20191231 14324-013_64434256-5f71-3a23-e053-2991aa0afee2 14324-013 HUMAN OTC DRUG SUN ULTIMATE FACE SPF 30 OCTINOXATE, OCTISALATE, HOMOSALATE, AVOBENZONE CREAM TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 NAOS OCTINOXATE; OCTISALATE; HOMOSALATE; AVOBENZONE 70; 50; 40; 25 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 14324-014_64432435-7050-09ba-e053-2991aa0aca13 14324-014 HUMAN OTC DRUG PHOTO REGUL FACE SPF 25 OCTISALATE, OCTINOXATE, HOMOSALATE, AVOBENZONE CREAM TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 NAOS OCTISALATE; OCTINOXATE; HOMOSALATE; AVOBENZONE 50; 49; 40; 30 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 14324-015_64432435-7064-09ba-e053-2991aa0aca13 14324-015 HUMAN OTC DRUG BRONZ REPAIR SEA AND TROPICS FACE SPF 25 OCTINOXATE, AVOBENZONE CREAM TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 NAOS OCTINOXATE; AVOBENZONE 60; 26 mg/mL; mg/mL N 20191231 14362-0111_a88e2e40-6ff0-49f0-a3ca-ed70f3f9e2f2 14362-0111 VACCINE Tetanus and Diphtheria Toxoids Adsorbed Tetanus and Diphtheria Toxoids Adsorbed INJECTION INTRAMUSCULAR 19700727 BLA BLA101322 MassBiologics CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2; 2 [Lf]/.5mL; [Lf]/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient] N 20181231 14498-001_60638975-d7e0-5b95-e053-2a91aa0ae902 14498-001 HUMAN PRESCRIPTION DRUG MTL1 Leucoflex Anticoagulant Citrate Phosphate Dextrose Solution with AS-1 KIT INTRAVENOUS 20051121 NDA BN040083 Maco Productions N 20181231 14498-002_4d87f877-878b-4705-b586-6a554c4fda13 14498-002 HUMAN PRESCRIPTION DRUG Leucoflex CGP Anticoagulant Citrate Phosphate Dextrose Solution with Additive Solution AS-1 KIT 20130531 NDA BN040083 Maco Productions N 20181231 14498-003_034e4d21-9b5d-4316-b465-c7d89148729a 14498-003 HUMAN PRESCRIPTION DRUG Sterile Cord Blood Collection Unit (MSC127D) Anticoagulant Citrate Phosphate Dextrose Solution INJECTION, SOLUTION INTRAVENOUS 20161221 NDA BN125552 Maco Productions SODIUM CITRATE; DEXTROSE MONOHYDRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE .92; .89; 114.5; 87.9 g/35mL; g/35mL; mg/35mL; mg/35mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20191231 14498-004_c62f5860-90d4-4312-ade7-eb22e55910b9 14498-004 HUMAN PRESCRIPTION DRUG Sterile Cord Blood Collection Unit (MSC128D) Anticoagulant Citrate Phosphate Dextrose Solution INJECTION, SOLUTION INTRAVENOUS 20161221 NDA BN125552 Maco Productions SODIUM CITRATE; DEXTROSE MONOHYDRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE .76; .74; 94.8; 72.8 g/29mL; g/29mL; mg/29mL; mg/29mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 14505-398_cb6c6e0c-0ae5-4c15-bbe2-0c2801106723 14505-398 HUMAN OTC DRUG Sanatos Day Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine LIQUID ORAL 20100204 OTC MONOGRAPH FINAL part341 Pharmalab Enterprises Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL E 20171231 14505-399_af1e5459-2fd9-4c0f-af63-bea42e73c14d 14505-399 HUMAN OTC DRUG Sanatos Night Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20100204 OTC MONOGRAPH FINAL part341 Pharmalab Enterprises Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL E 20171231 14505-400_f7ff7fd5-9d0e-465c-8440-c84ab2fd23d1 14505-400 HUMAN OTC DRUG Desempacho Cucharadas Bismuth Subsalicylate LIQUID ORAL 20090109 OTC MONOGRAPH FINAL part335 Pharmalab Enterprises Inc. BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 14505-488_0f4bf76c-85e8-4941-91a8-ef14fedab1b7 14505-488 HUMAN OTC DRUG Bisolvine Child Guaifenesin, Dextromethorphan LIQUID ORAL 20100218 OTC MONOGRAPH FINAL part341 Pharmalab Enterprises Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 100; 10 mg/5mL; mg/5mL N 20181231 14537-408_1ed5707f-53c1-45bb-a580-aff7ae27c8b4 14537-408 HUMAN PRESCRIPTION DRUG Isoplate SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, and POTASSIUM PHOSPHATE, MONOBASIC SOLUTION INTRAVENOUS 20130305 NDA BN090067 Terumo BCT Ltd. SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC .53; .5; .37; .037; .03; .008; .00082 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 14537-966_af4cef32-30bd-4471-baec-21f36bb7b06f 14537-966 HUMAN PRESCRIPTION DRUG AS 3 Dextrose Monohydrate, Sodium Citrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate and Adenine INJECTION, SOLUTION INTRAVENOUS 20020529 NDA BN001214 Terumo BCT Ltd DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; CITRIC ACID MONOHYDRATE; ADENINE 1.1; .588; .41; .276; .042; .03 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 14537-967_66e7629c-27ad-4a39-982d-1c56e38156b6 14537-967 HUMAN PRESCRIPTION DRUG ACD A Dextrose Monohydrate, Sodium Citrate, and Citric Acid Monohydrate INJECTION, SOLUTION INTRAVENOUS 20020225 ANDA BA010228 Terumo BCT Ltd DEXTROSE MONOHYDRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE 2.45; 2.2; .8 g/100mL; g/100mL; g/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 14539-150_ca67721d-0287-46d2-bffe-83748f21f6fd 14539-150 HUMAN PRESCRIPTION DRUG POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20110928 ANDA ANDA202071 Emcure Pharmaceuticals USA Inc. POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 14593-124_17bc96cc-3486-4bc3-84e6-89497789f8f1 14593-124 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20091117 ANDA ANDA090125 Emcure Pharmaceuticals Ltd. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 14720-371_a16a9ff7-c2a9-4f17-bdb5-4bdb2eba1608 14720-371 HUMAN OTC DRUG Double Prawn Rumagon Methyl Salicylate, Turpentine LINIMENT TOPICAL 20010805 OTC MONOGRAPH FINAL part348 Tai Tong Ah Co., Pte. Ltd. METHYL SALICYLATE; TURPENTINE 16.8; 6.72 mL/28mL; mL/28mL E 20171231 14720-372_53601099-5e12-4e1a-82dc-2fc3f08128fa 14720-372 HUMAN OTC DRUG Double Prawn Brand Herbal Oil Benzocaine, Menthol OIL TOPICAL 20041227 OTC MONOGRAPH FINAL part346 Tai Tong Ah Co Pte Ltd MENTHOL 3.5 g/100mL E 20171231 14743-085_c138e606-ccbf-4db3-b5ec-4bd5ea66c706 14743-085 HUMAN OTC DRUG Tahitian Noni TePoema Element Shield SPF 20 Avobenzone, Octinoxate, Octisalate LOTION TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part352 Tahitian Noni International Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 2 g/100mL; g/100mL; g/100mL N 20181231 14743-101_d7b2879c-562e-4afc-a629-ff92273acfa7 14743-101 HUMAN OTC DRUG Tahitian Noni Lip Balm Berry SPF15 Octinoxate, Oxybenzone OINTMENT TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 Tahitian Noni International Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g N 20181231 14743-102_fcfcacf1-3bd4-4f54-aa64-234d2becacd4 14743-102 HUMAN OTC DRUG Tahitian Noni Lip Balm Pineapple SPF15 Octinoxate, Oxybenzone OINTMENT TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 Tahitian Noni International Inc OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g N 20181231 14743-103_cdc4b3d0-379b-44a4-b402-98dafee0ea66 14743-103 HUMAN OTC DRUG Tahitian Noni Original Lip Balm SPF15 Octinoxate, Oxybenzone OINTMENT TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 Tahitian Noni International OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g N 20181231 14743-270_6b82cb4b-9548-45b2-ae75-3eda842dacd2 14743-270 HUMAN OTC DRUG Morinda TruAge Therapy Element Shield SPF 20 OCtinoxate, Ocitsalate, Avobenzone LOTION TOPICAL 20160401 OTC MONOGRAPH FINAL part352 Tahitian Noni International OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 14743-285_4028495e-ceed-4444-a489-b6375901bada 14743-285 HUMAN OTC DRUG TruAge AGE Therapy Lip Balm SPF15 Octinoxate, Octocrylene, Oxybenzone, Avobenzone STICK TOPICAL 20160401 OTC MONOGRAPH FINAL part352 Tahitian Noni International OCTINOXATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 7.5; 4; 3; 2.5 g/100g; g/100g; g/100g; g/100g N 20181231 14743-336_4bf2bfa5-4eba-4a2a-a802-fa25fdeb7fb6 14743-336 HUMAN OTC DRUG TruAge Lip Balm Pink Grapefruit SPF15 Avobenzone, Ocitnoxate, Octocrylene, Oxybenzone LIPSTICK TOPICAL 20161201 OTC MONOGRAPH FINAL part352 Tahitian Noni International AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 2.5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 14743-337_6c92dfb4-accd-40c3-85af-5657f4d7503b 14743-337 HUMAN OTC DRUG TruAge Lip Balm Pomegranate Mint SPF15 Avobenzone, Ocitnoxate, Octocrylene, Oxybenzone LIPSTICK TOPICAL 20161201 OTC MONOGRAPH FINAL part352 Tahitian Noni International AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 2.5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 14743-344_059473d3-194e-47a7-8692-223a22380147 14743-344 HUMAN OTC DRUG TeMana Tahiti Noni Brightening Facial Shield SPF50 Avobenzone, Octinoxate, Ensulizole LOTION TOPICAL 20171213 OTC MONOGRAPH NOT FINAL part352 Tahitian Noni International AVOBENZONE; ENSULIZOLE; OCTINOXATE 7.35; 3; 1.85 g/100g; g/100g; g/100g N 20181231 14743-536_685c76f8-dc8c-4e84-9638-fbd1f81ea7f5 14743-536 HUMAN OTC DRUG Tahitian Noni Sunscreen SPF 30 Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100628 OTC MONOGRAPH NOT FINAL part352 Tahitian Noni International AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 6.5; 7; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 14783-000_862def39-9cee-4c25-901f-8bb8ef25023a 14783-000 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 CLAIRE 1 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-001_862def39-9cee-4c25-901f-8bb8ef25023a 14783-001 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 CLAIRE 2 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-002_862def39-9cee-4c25-901f-8bb8ef25023a 14783-002 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 CLAIRE 3 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-003_862def39-9cee-4c25-901f-8bb8ef25023a 14783-003 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 CLAIRE 4 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-004_862def39-9cee-4c25-901f-8bb8ef25023a 14783-004 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 MEDIUM 5 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-005_862def39-9cee-4c25-901f-8bb8ef25023a 14783-005 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 MEDIUM 6 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-006_862def39-9cee-4c25-901f-8bb8ef25023a 14783-006 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 MEDIUM 7 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-007_862def39-9cee-4c25-901f-8bb8ef25023a 14783-007 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL natural skin effect mousse foundation SPF 16 OBSCURE 8 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20161102 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-008_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-008 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (MALVE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-009_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-009 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (MARRON GLACE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-010_877ec1e1-4c0f-4f81-8e13-6ecd30955e91 14783-010 HUMAN OTC DRUG LBEL EFFET PARFAIT Signs of age appearance minimizer foundation SPF 20 Octinoxate and Titanium Dioxide LOTION TOPICAL 20120914 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; TITANIUM DIOXIDE .07; .024 g/mL; g/mL E 20171231 14783-011_c3d86ea0-9722-4082-9fdf-2d3ac62b60f3 14783-011 HUMAN OTC DRUG LBEL EFFET PARFAIT OCTINOXATE, OXYBENZONE, and TITANIUM DIOXIDE LIPSTICK TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .03; .008 g/g; g/g; g/g E 20171231 14783-012_ddb9f3ce-cb3c-41cb-9b16-db887cdcb0e3 14783-012 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20120914 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-013_40004acb-f09e-4a93-a249-c80242ed8804 14783-013 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL TITANIUM DIOXIDE, OXYBENZONE, ZINC OXIDE, and OCTINOXATE POWDER TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited TITANIUM DIOXIDE; OXYBENZONE; ZINC OXIDE; OCTINOXATE .06; .05; .049; .035 g/g; g/g; g/g; g/g E 20171231 14783-014_964c3114-9322-4965-9d9a-4b9a04fb5ef1 14783-014 HUMAN OTC DRUG LBEL LEDERM 35plus Jour SPF 15 Facial Treatment Against First Signs of Aging Day - Oily Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura International LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g E 20171231 14783-015_33568657-22d1-46b1-873d-fa17bfe7a3af 14783-015 HUMAN OTC DRUG LBEL LEDERM 35plus Jour SPF 15 Facial Treatment Against First Signs of Aging Day - Normal to Dry Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura International LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g N 20181231 14783-016_46183f7d-7b25-4156-a87f-ee6a2a113702 14783-016 HUMAN OTC DRUG LBEL LEDERM 45plus Jour SPF 15 Facial Treatment Against Noticeable Signs of Aging Day - Oily Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura International LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g E 20171231 14783-017_c5c5d096-9509-4435-95e8-8487cf7a12a1 14783-017 HUMAN OTC DRUG LBEL LEDERM 45plus Jour SPF 15 Facial Treatment Against Noticeable Signs of Aging Day - Normal to Dry Skin Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura International LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g N 20181231 14783-018_0c3c71b9-8f8d-4de9-8fe4-04a2cb405093 14783-018 HUMAN OTC DRUG LBel Paris Renovance Jour Octinoxate, Octocrylene, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTOCRYLENE; OXYBENZONE .075; .05; .03 g/g; g/g; g/g E 20171231 14783-019_f5ff921a-c276-4658-9cb2-95333590cd80 14783-019 HUMAN OTC DRUG LBEL LEDERM 55plus Jour SPF 15 Facial Treatment Against Advanced Signs of Aging Day - All Skin Types Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Ventura International LTD. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/g; g/g; g/g; g/g E 20171231 14783-020_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-020 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (TULIP) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-021_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-021 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (NUDE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-022_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-022 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (LILY BEIGE) - BEIGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-023_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-023 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (MANDARINE) - ORANGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-024_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-024 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (VIN) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-025_8bb9e858-d994-4a1a-80d2-777a2dfba3e2 14783-025 HUMAN OTC DRUG LBEL REGRESSION JOUR Protective Complex with SPF 15 Facial day normal to dry skin Avobenzone, Ensulizole, Octinoxate, and Oxybenzone CREAM TOPICAL 20120514 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. AVOBENZONE; ENSULIZOLE; OCTINOXATE; OXYBENZONE .02; .01; .075; .02 g/g; g/g; g/g; g/g E 20171231 14783-026_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-026 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (TEA ROSE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-027_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-027 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (FRENESIE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-028_0c3c71b9-8f8d-4de9-8fe4-04a2cb405093 14783-028 HUMAN OTC DRUG LBel Paris Renovance Jour Octinoxate, Octocrylene, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTOCRYLENE; OXYBENZONE .375; .25; .15 g/5g; g/5g; g/5g E 20171231 14783-029_cc68be31-6278-4868-b80a-c67096627a83 14783-029 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Claire 1-2-3 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g E 20171231 14783-030_cc68be31-6278-4868-b80a-c67096627a83 14783-030 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Claire 4 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g E 20171231 14783-031_cc68be31-6278-4868-b80a-c67096627a83 14783-031 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Medium 5 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g E 20171231 14783-032_cc68be31-6278-4868-b80a-c67096627a83 14783-032 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Medium 6 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g E 20171231 14783-033_cc68be31-6278-4868-b80a-c67096627a83 14783-033 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Medium 7 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g E 20171231 14783-034_cc68be31-6278-4868-b80a-c67096627a83 14783-034 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition Obscure 8-9 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g E 20171231 14783-035_4922ce2e-1697-4239-a440-41c84aa55b30 14783-035 HUMAN OTC DRUG LBel Paris Regression Jour Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTISALATE; OXYBENZONE .75; .04; 2 g/g; g/g; g/g E 20171231 14783-036_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-036 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (RICHE PINK) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-037_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-037 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (RED EXTASSY) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-038_0c3c71b9-8f8d-4de9-8fe4-04a2cb405093 14783-038 HUMAN OTC DRUG LBel Paris Renovance Jour Octinoxate, Octocrylene, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3.75; 2.5; 1.5 g/50g; g/50g; g/50g E 20171231 14783-039_35041b4f-d141-4cf0-91c9-829ff347fe90 14783-039 HUMAN OTC DRUG LBel Paris Regression Jour Avobenzone, Ensulizole, Octinoxate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD AVOBENZONE; ENSULIZOLE; OCTINOXATE; OXYBENZONE .1; .05; .375; .1 g/5g; g/5g; g/5g; g/5g E 20171231 14783-040_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-040 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (FUCSIA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-041_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-041 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (SOLEIL) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-042_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-042 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (TERRE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-043_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-043 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (CHERRY BLOSSOM) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-044_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-044 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (VIN AMANT) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-045_4922ce2e-1697-4239-a440-41c84aa55b30 14783-045 HUMAN OTC DRUG LBel Paris Regression Jour Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTISALATE; OXYBENZONE .375; .2; .2 g/5g; g/5g; g/5g E 20171231 14783-046_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-046 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (NUDE INTIME) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-047_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-047 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (MOKA) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-048_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-048 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (ROMANCE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-049_35041b4f-d141-4cf0-91c9-829ff347fe90 14783-049 HUMAN OTC DRUG LBel Paris Regression Jour Avobenzone, Ensulizole, Octinoxate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD AVOBENZONE; ENSULIZOLE; OCTINOXATE; OXYBENZONE 1; .5; 3.75; 1 g/50g; g/50g; g/50g; g/50g E 20171231 14783-050_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-050 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (ROSE NATURAL) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-051_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-051 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (ROJO CLASIQUE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-052_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-052 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (ROUGE INTENSE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-053_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-053 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (AMOUR) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-054_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-054 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (CHOCOLAT) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-055_4922ce2e-1697-4239-a440-41c84aa55b30 14783-055 HUMAN OTC DRUG LBel Paris Regression Jour Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTISALATE; OXYBENZONE 3.75; 2; 2 g/50g; g/50g; g/50g E 20171231 14783-056_1865a6da-ed21-4419-82a8-f94342252275 14783-056 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Claire 1-2-3 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g N 20181231 14783-057_1865a6da-ed21-4419-82a8-f94342252275 14783-057 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Claire 4 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g N 20181231 14783-058_1865a6da-ed21-4419-82a8-f94342252275 14783-058 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Medium 5 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g N 20181231 14783-059_1865a6da-ed21-4419-82a8-f94342252275 14783-059 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Medium 6 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g N 20181231 14783-060_1865a6da-ed21-4419-82a8-f94342252275 14783-060 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Medium 7 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g N 20181231 14783-061_1865a6da-ed21-4419-82a8-f94342252275 14783-061 HUMAN OTC DRUG LBEL DIVINE Polvos compactos doble uso FPS 15 edicion de lujo dorado/Double use compact SPF 15 gold deluxe edition Obscure 8-9 Titanium Dioxide, Zinc Oxide, and Octinoxate POWDER TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .062393; .049; .03 g/g; g/g; g/g N 20181231 14783-062_f9c27f44-9167-439a-a8bf-0280eabe477e 14783-062 HUMAN OTC DRUG LBel Supremacie Mains Ensulizole, Octinoxate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., ENSULIZOLE; OCTINOXATE; OXYBENZONE .15; .38; .31 g/5mL; g/5mL; g/5mL E 20171231 14783-063_68e7f654-1084-4bb6-bf28-7035076a45b7 14783-063 HUMAN OTC DRUG LBEL EFFET PARFAIT HYDRATESS long-lasting intense moisturizing SPF 20 (ALMOND) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .16 g/g; g/g E 20171231 14783-064_24be275e-f923-4bdf-ac2d-542498633561 14783-064 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 1 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-065_24be275e-f923-4bdf-ac2d-542498633561 14783-065 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 2 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-066_24be275e-f923-4bdf-ac2d-542498633561 14783-066 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 1 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-067_24be275e-f923-4bdf-ac2d-542498633561 14783-067 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 2 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-068_24be275e-f923-4bdf-ac2d-542498633561 14783-068 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 3 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-069_24be275e-f923-4bdf-ac2d-542498633561 14783-069 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 4 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-070_24be275e-f923-4bdf-ac2d-542498633561 14783-070 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 5 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-071_24be275e-f923-4bdf-ac2d-542498633561 14783-071 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 1 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-072_f9c27f44-9167-439a-a8bf-0280eabe477e 14783-072 HUMAN OTC DRUG LBel Supremacie Mains Ensulizole, Octinoxate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., ENSULIZOLE; OCTINOXATE; OXYBENZONE 3; 7.5; 6.2 g/100mL; g/100mL; g/100mL E 20171231 14783-073_24be275e-f923-4bdf-ac2d-542498633561 14783-073 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 2 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-074_24be275e-f923-4bdf-ac2d-542498633561 14783-074 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 1 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-075_24be275e-f923-4bdf-ac2d-542498633561 14783-075 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 2 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-076_24be275e-f923-4bdf-ac2d-542498633561 14783-076 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 3 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-077_41fa1e15-8b5e-45d6-adde-1769e084fa3b 14783-077 HUMAN OTC DRUG LBel Clarifique Dermo Radiance Mains SPF 15 Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 6 g/100g; g/100g; g/100g E 20171231 14783-078_24be275e-f923-4bdf-ac2d-542498633561 14783-078 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 4 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-079_24be275e-f923-4bdf-ac2d-542498633561 14783-079 HUMAN OTC DRUG ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 5 - BEIGE Octinoxate and Zinc Oxide LOTION TOPICAL 20161216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .065; .036 g/g; g/g N 20181231 14783-080_4b86ed3f-f168-4c7c-8aa4-e536ab00d3fe 14783-080 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 CLAIRE 1 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 14783-081_e332c9be-a94b-433d-a793-86454e82dcb1 14783-081 HUMAN OTC DRUG LBel Couleur Luxe Rouge Amplifier XP Octinoxate and Oxybenzone LIPSTICK TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .18; .0036 g/4g; g/4g E 20171231 14783-082_4b86ed3f-f168-4c7c-8aa4-e536ab00d3fe 14783-082 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 CLAIRE 2 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 14783-083_84e83063-f93c-4935-a846-5bb9decb9ebe 14783-083 HUMAN OTC DRUG LBel Couleur Luxe Supreme XP Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .0392; .0188; .0376 g/4g; g/4g; g/4g E 20171231 14783-084_4b86ed3f-f168-4c7c-8aa4-e536ab00d3fe 14783-084 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 CLAIRE 3 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 14783-085_8166e1da-a159-41d9-b097-3c64bbf5ad87 14783-085 HUMAN OTC DRUG LBel Supremacie Teint Octinoxate CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD., OCTINOXATE 1.35 g/30g E 20171231 14783-086_4b86ed3f-f168-4c7c-8aa4-e536ab00d3fe 14783-086 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 CLAIRE 4 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 14783-087_4b86ed3f-f168-4c7c-8aa4-e536ab00d3fe 14783-087 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 MEDIUM 5 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 14783-088_4b86ed3f-f168-4c7c-8aa4-e536ab00d3fe 14783-088 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 MEDIUM 6 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 14783-089_4b86ed3f-f168-4c7c-8aa4-e536ab00d3fe 14783-089 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 MEDIUM 7 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 14783-090_4b86ed3f-f168-4c7c-8aa4-e536ab00d3fe 14783-090 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 OBSCURE 8 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 14783-091_bd919d7b-baa6-4d7d-920a-9a2b3dc49249 14783-091 HUMAN OTC DRUG LBel Effet Parfit Titanium dioxide POWDER TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ventura International LTD TITANIUM DIOXIDE .55 g/11g E 20171231 14783-092_4b86ed3f-f168-4c7c-8aa4-e536ab00d3fe 14783-092 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 OBSCURE 9 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 14783-093_5248e1b3-7ab6-45f9-8e92-91a4432d4c5d 14783-093 HUMAN OTC DRUG Supremacie NX Jour Ensulizole, Homosalate, Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20100104 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD ENSULIZOLE; HOMOSALATE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .00075; .001; .00375; .00225; .000585 g/5mL; g/5mL; g/5mL; g/5mL; g/5mL E 20171231 14783-094_56625705-f317-4a80-9167-edcfacaf5d93 14783-094 HUMAN OTC DRUG LBEL UV DEFENSE 365 Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide LOTION/SHAMPOO TOPICAL 20110829 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. (San Juan, P.R) HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .05; .07; .05; .04; .0624; .0388 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 14783-095_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-095 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MOKA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-096_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-096 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROMANCE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-097_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-097 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROSE NATURAL Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-098_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-098 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROSE CLASIQUE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-099_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-099 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ROUGE INTENSE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-100_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-100 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - AMOUR Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-101_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-101 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - CHOCOLAT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-102_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-102 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - ALMOND Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-103_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-103 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MALVE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-104_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-104 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MARRON GLACE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-105_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-105 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - TULIP Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-106_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-106 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - NUDE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-107_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-107 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - LILY BEIGE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-108_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-108 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - MANDARINE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-109_dd074e49-76ff-4d46-9c81-2ddf3dc05223 14783-109 HUMAN OTC DRUG LBEL HYDRATESS long-lasting intense moisturizing SPF 20 - VIN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-110_4b86ed3f-f168-4c7c-8aa4-e536ab00d3fe 14783-110 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 TONO HUT - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 14783-111_283abfd8-e454-4848-af01-0b9224b4a2bf 14783-111 HUMAN OTC DRUG LBEL Defense Total Compact Suncreen SPF 50 For Face - Matte Finish Octinoxate, Octocrylene, and Zinc Oxide CREAM TOPICAL 20170418 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OCTOCRYLENE; ZINC OXIDE .07; .05; .1666 g/g; g/g; g/g N 20181231 14783-112_a9feb58b-4d37-49d1-a57e-8c61277697b1 14783-112 HUMAN OTC DRUG Esika Pro HIDRACOLOR 3 in 1 Moisturizing, Color and Perfecting Effect SPF 25 OCTINOXATE and ZINC OXIDE LIPSTICK TOPICAL 20170419 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; ZINC OXIDE .075; .0392 g/g; g/g N 20181231 14783-113_f3554855-2b46-4121-8d53-0e44633d736b 14783-113 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (CAFE PARISO) - BROWN Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-114_f3554855-2b46-4121-8d53-0e44633d736b 14783-114 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (ROSE BLOOM) - RED Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-115_f3554855-2b46-4121-8d53-0e44633d736b 14783-115 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (FRESA ENERGY) - RED Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-116_f3554855-2b46-4121-8d53-0e44633d736b 14783-116 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (BURGUNDY VITAL) - RED Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-117_f3554855-2b46-4121-8d53-0e44633d736b 14783-117 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (VINO SUBLIME) - RED Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-118_f3554855-2b46-4121-8d53-0e44633d736b 14783-118 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (ROJO RADIANT) - RED Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-119_257bb9f4-6562-4102-bb5f-1b6983ddf130 14783-119 HUMAN OTC DRUG LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 day facial SPF 15 against noticeable signs of aging all skin types AVOBENZONE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20170915 OTC MONOGRAPH FINAL part352 Ventura International AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 30; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 14783-121_652ed997-a464-4c52-870e-28c8bf3e3083 14783-121 HUMAN OTC DRUG LBEL Divine Lip Gloss SPF 15 Octinoxate and Oxybenzone LOTION TOPICAL 20111114 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. (San Juan, P.R) OCTINOXATE; OXYBENZONE .075; .03 mL/mL; mL/mL E 20171231 14783-140_36f6fbf5-166f-47a3-b864-60de558168e2 14783-140 HUMAN OTC DRUG EFFET PARFAIT natural finish moisturizing foundation SPF 25 Octinoxate and Titanium Dioxide LOTION TOPICAL 20100916 OTC MONOGRAPH NOT FINAL part352 VENTURA INTERNATIONAL LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 mL/mL; mL/mL E 20171231 14783-150_36f6fbf5-166f-47a3-b864-60de558168e2 14783-150 HUMAN OTC DRUG EFFET PARFAIT natural finish moisturizing foundation SPF 25 Octinoxate and Titanium Dioxide LOTION TOPICAL 20100916 OTC MONOGRAPH NOT FINAL part352 VENTURA INTERNATIONAL LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 mL/mL; mL/mL E 20171231 14783-160_36f6fbf5-166f-47a3-b864-60de558168e2 14783-160 HUMAN OTC DRUG EFFET PARFAIT natural finish moisturizing foundation SPF 25 Octinoxate and Titanium Dioxide LOTION TOPICAL 20100916 OTC MONOGRAPH NOT FINAL part352 VENTURA INTERNATIONAL LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 mL/mL; mL/mL E 20171231 14783-170_36f6fbf5-166f-47a3-b864-60de558168e2 14783-170 HUMAN OTC DRUG EFFET PARFAIT natural finish moisturizing foundation SPF 25 Octinoxate and Titanium Dioxide LOTION TOPICAL 20100916 OTC MONOGRAPH NOT FINAL part352 VENTURA INTERNATIONAL LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 mL/mL; mL/mL E 20171231 14783-200_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-200 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 1) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL E 20171231 14783-201_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-201 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 2) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL E 20171231 14783-202_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-202 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 3) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL E 20171231 14783-203_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-203 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 4) - BEIGE Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL E 20171231 14783-204_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-204 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 5) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL E 20171231 14783-205_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-205 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 6) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL E 20171231 14783-206_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-206 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 7) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL E 20171231 14783-207_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-207 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 8) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL E 20171231 14783-208_8ef66f04-ff18-4da3-b355-2cdb4ea2f86c 14783-208 HUMAN OTC DRUG LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 9) - BROWN Octinoxate LIQUID TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE .07 g/mL E 20171231 14783-226_759d0a35-ec8c-4afb-b9c6-fcf30f3499be 14783-226 HUMAN OTC DRUG LBEL Lip Moisturizer SPF 18 Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .03; .08 g/g; g/g; g/g E 20171231 14783-240_063e6e3a-0506-4d86-9401-d37160f2b53d 14783-240 HUMAN OTC DRUG LBEL EFFET PARFAIT OCTINOXATE and OXYBENZONE POWDER TOPICAL 20100816 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. (San Francisco, CA) OCTINOXATE; OXYBENZONE .075; .02 g/g; g/g E 20171231 14783-241_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-241 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 1) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-242_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-242 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 2) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-243_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-243 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 3) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-244_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-244 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 4) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-245_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-245 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 5) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-246_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-246 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 6) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-247_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-247 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 7) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-248_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-248 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-249_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-249 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 9) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-250_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-250 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 6A) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-251_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-251 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (MEDIUM 6B) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-252_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-252 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8A) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-253_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-253 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8B) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-254_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-254 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8C) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-255_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-255 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 10) - BROWN Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-256_df1a63be-d4c1-49a0-978e-c1744c051eb8 14783-256 HUMAN OTC DRUG LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (DORE 6) - BEIGE Octinoxate and Titanium Dioxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .065; .016 g/mL; g/mL E 20171231 14783-266_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-266 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 1) - BEIGE Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL E 20171231 14783-267_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-267 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 2) - BEIGE Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL E 20171231 14783-268_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-268 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 3) - BEIGE Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL E 20171231 14783-269_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-269 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 4) - BEIGE Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL E 20171231 14783-270_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-270 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 5) - BROWN Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL E 20171231 14783-271_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-271 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 6) - BROWN Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL E 20171231 14783-272_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-272 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 7) - BROWN Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL E 20171231 14783-273_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-273 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 8) - BROWN Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL E 20171231 14783-274_c4ffde81-0367-4c19-b79c-e8d255c53798 14783-274 HUMAN OTC DRUG LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 9) - BROWN Zinc oxide LIQUID TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Ventura International LTD ZINC OXIDE .016 g/mL E 20171231 14783-301_723f46da-0a2c-4f0b-94cb-503c5ef931bb 14783-301 HUMAN OTC DRUG LBEL PROTEGE EXPERT Octinoxate, Octisalate, Oxybenzone, and Titanium dioxide LOTION TOPICAL 20110419 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .075; .05; .06; .0234 g/mL; g/mL; g/mL; g/mL E 20171231 14783-302_710facca-d47f-478c-8baf-37d7b5a80fa5 14783-302 HUMAN OTC DRUG Esika Silk Skin OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .02; .044 g/g; g/g E 20171231 14783-304_addec3e3-ea22-46cd-b788-e88efd85c920 14783-304 HUMAN OTC DRUG LBEL PROTEGE EXPERT Ensulizole, Octinoxate, Octisalate, Oxybenzone, and Titanium dioxide LOTION TOPICAL 20110419 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. ENSULIZOLE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .03; .075; .05; .06; .039 g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 14783-305_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-305 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE CHAMPAGNE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-306_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-306 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - FUCSIA SPLENDIDE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-307_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-307 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE DAMOUR Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-308_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-308 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE FORMIDABLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-309_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-309 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - NATURAL PERSISTANT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-310_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-310 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MIEL ECHANTER Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-311_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-311 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE PRODIGEUX Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-312_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-312 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MARRON ILLIMITE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-313_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-313 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CHOCOLAT MAJESTIC Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-314_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-314 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CAFE SUCCES Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-315_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-315 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE GRANDOISE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-316_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-316 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE RUBI Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-317_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-317 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - SAUMON ESSENTIEL Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-318_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-318 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - BOURGOGNE VIF Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-319_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-319 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - VIOLET POURPRE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-320_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-320 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CORAIL MAXIMUM Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-321_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-321 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ORANGE DELIRANT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-322_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-322 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE INTENSE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-323_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-323 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE FEMME Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-324_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-324 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - DORE CHOCOLAT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-325_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-325 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MER DE ROSES Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-326_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-326 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE TENTATION Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-327_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-327 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE DELICAT Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-328_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-328 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - FUCSIA DESIR Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-329_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-329 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROUGE PROVOCATION Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-330_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-330 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - AMPLIFFIER AMANDIER Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-331_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-331 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - SOBRIETE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-332_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-332 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - FIANCEE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-333_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-333 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROMANCE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-334_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-334 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - CARMINE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-335_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-335 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - NOBLESSE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-336_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-336 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - MALBEC Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-337_d2dbc556-fe41-43d2-a7c3-603f3a0ba62a 14783-337 HUMAN OTC DRUG LBEL COULEUR LUXE AMPLIFIER XP amplifying SPF 15 - ROSE FUCSIA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD. OCTINOXATE; OXYBENZONE .047; .009 g/g; g/g E 20171231 14783-383_61a536ec-558e-4699-825a-364c71ef0b6a 14783-383 HUMAN OTC DRUG LBEL Defense Total broad spectrum SPF 50 plus sunscreen for face and body Avobenzone, Homosalate, and Octocrylene LOTION TOPICAL 20150522 OTC MONOGRAPH FINAL part352 Ventura International LTD AVOBENZONE; HOMOSALATE; OCTOCRYLENE .03; .1; .08 g/mL; g/mL; g/mL E 20171231 14783-400_da6ec481-b844-411c-a101-1b8eae6c6c1e 14783-400 HUMAN OTC DRUG LBEL Hydra Calme SPF 15 Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE .075; .04; .04 g/mL; g/mL; g/mL E 20171231 14783-434_3cc7d79e-48a5-440a-a5e7-ca9048ee07f0 14783-434 HUMAN OTC DRUG LBEL Dermo Clarite Avobenzone, Ensulizole, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111126 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .03; .05; .05; .06 g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 14783-435_4fe4cd9a-fdfc-45ae-90e3-17bfb4addb57 14783-435 HUMAN OTC DRUG LBEL DRY EFFECT 48 Aluminum Sesquichlorohydrate LIQUID TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Ventura International Ltd ALUMINUM SESQUICHLOROHYDRATE .18 g/mL E 20171231 14783-436_a8f69d9d-7d56-49a6-8245-6000113f7471 14783-436 HUMAN OTC DRUG LBEL HOMME ANTIDANDRUFF Pyrithione Zinc SHAMPOO TOPICAL 20120120 OTC MONOGRAPH FINAL part358H Ventura International Ltd PYRITHIONE ZINC .00336 g/mL E 20171231 14783-437_fb9bf5e9-4358-4323-a36d-979ab3f7bdf2 14783-437 HUMAN OTC DRUG LBEL DRY EFFECT 48 ALUMINUM CHLOROHYDRATE AEROSOL, SPRAY TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Ventura International Ltd ALUMINUM CHLOROHYDRATE .24 g/mL E 20171231 14783-438_6017bc97-c212-4454-8d1c-06acd24ef425 14783-438 HUMAN OTC DRUG LBEL Effet Parfait maximum comfort and long-lasting foundation spf 10 Zinc Oxide LOTION TOPICAL 20120210 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd. ZINC OXIDE .0157 g/mL E 20171231 14783-441_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-441 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROSE NATURAL) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-442_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-442 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROJO VIF) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-443_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-443 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (MOKA) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-444_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-444 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (MANDARINE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-445_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-445 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (CAPUCCINO) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-446_ca71761d-0b6d-491d-ae64-7f234b1d4428 14783-446 HUMAN OTC DRUG LBel EFFET PARFAIT TITANIUM DIOXIDE, OXYBENZONE, and OCTINOXATE POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd TITANIUM DIOXIDE; OXYBENZONE; OCTINOXATE .04425; .03; .04 g/g; g/g; g/g E 20171231 14783-447_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-447 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (FUCHSIA INTENSE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-448_2b1b12cf-a540-4abd-b6dd-d284d725e067 14783-448 HUMAN OTC DRUG LBel EFFET PARFAIT Loose Extra-Fine Portable TITANIUM DIOXIDE, OXYBENZONE, and OCTINOXATE POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Ventura International Ltd TITANIUM DIOXIDE; OXYBENZONE; OCTINOXATE .035; .03; .03 g/g; g/g; g/g E 20171231 14783-449_5aae0369-5563-45b6-a28f-1a8aa5429107 14783-449 HUMAN OTC DRUG ESIKA MEN MAXIMUM STRENGTH PYRITHIONE ZINC LIQUID TOPICAL 20120124 OTC MONOGRAPH FINAL part358H Ventura International Ltd PYRITHIONE ZINC .00528 g/mL E 20171231 14783-450_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-450 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (FUCHSIA BRILLANCE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-451_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-451 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROSE BRILLANCE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-452_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-452 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROSE CLASSIQUE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-453_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-453 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (VIN) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-454_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-454 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROUGE BRILLANCE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-455_addd969b-5d25-42a9-8ac1-3a6ab4771dfe 14783-455 HUMAN OTC DRUG LBEL Couleur luxe rouge irresistible maximum hydration SPF 17 (ROUGE INTENSE) - PURPLE Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140131 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-467_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-467 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (PECHE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-468_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-468 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (GRAPE LUMIERE) - MAGENTA Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-469_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-469 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (SWEET FRAMBOISE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-470_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-470 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (DOUCE) - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-471_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-471 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (VIN) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-472_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-472 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (CARAMEL MELON) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-473_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-473 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (GROSEILLE) - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-474_f55025ad-f9d9-423a-9f92-2013ea447c85 14783-474 HUMAN OTC DRUG LBEL divine lip gloss SPF 15 (VIN SENSUELLE) - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140127 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-550_43d6cd8f-8279-4775-953c-44fe3a6e0a11 14783-550 HUMAN OTC DRUG LBel Protege Expert Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium dioxide CREAM TOPICAL 20110419 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE .075; .04; .1; .06; .01 g/g; g/g; g/g; g/g; g/g E 20171231 14783-600_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-600 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 1) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-601_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-601 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 2) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-602_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-602 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 3) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-603_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-603 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (CLAIRE 4) - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-604_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-604 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 5) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-605_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-605 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 6) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-606_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-606 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (MEDIUM 7) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-607_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-607 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (OBSCURE 8) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-608_b19e0a7b-0aa8-4641-9496-3676d4954e01 14783-608 HUMAN OTC DRUG LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSSE FOUNDATION SPF 16 (OBSCURE 9) - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20140428 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-660_14e8f5a0-541f-4968-ab49-3717c35559f1 14783-660 HUMAN OTC DRUG LBEL Couler Luxe Supreme XP Rosace, Excentrique, Harmonie Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK TOPICAL 20101126 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .0098; .0047; .0094 g/g; g/g; g/g E 20171231 14783-661_14e8f5a0-541f-4968-ab49-3717c35559f1 14783-661 HUMAN OTC DRUG LBEL Couler Luxe Supreme XP Sublime, Orange, Sobriete Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK TOPICAL 20101126 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .0098; .0047; .0094 g/g; g/g; g/g E 20171231 14783-721_88fae847-09dd-43ac-a478-2dd93d5ccfbe 14783-721 HUMAN OTC DRUG LBEL EFFET PARFAIT Loose extra-fine portable SPF 15 FM PORCELAINE- BEIGE Octinoxate, Titanium Dioxide, and Oxybenzone POWDER TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE .03; .0354; .03 g/g; g/g; g/g N 20181231 14783-722_88fae847-09dd-43ac-a478-2dd93d5ccfbe 14783-722 HUMAN OTC DRUG LBEL EFFET PARFAIT Loose extra-fine portable SPF 15 FM TRANSLUCIDE- BEIGE Octinoxate, Titanium Dioxide, and Oxybenzone POWDER TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE .03; .0354; .03 g/g; g/g; g/g N 20181231 14783-723_88fae847-09dd-43ac-a478-2dd93d5ccfbe 14783-723 HUMAN OTC DRUG LBEL EFFET PARFAIT Loose extra-fine portable SPF 15 FM SANTE- BEIGE Octinoxate, Titanium Dioxide, and Oxybenzone POWDER TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE .03; .0354; .03 g/g; g/g; g/g N 20181231 14783-770_ca7ee1e2-06a6-42f4-8be5-a202b052082d 14783-770 HUMAN OTC DRUG LBEL Effet Parfait Mineral Natural Skin Effect Mouse Foundation OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20101126 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .016 g/g; g/g; g/g E 20171231 14783-800_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-800 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (BELLE NUDE) - BEIGE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-801_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-801 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (FUCSIA PASSION) - PURPLE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-802_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-802 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (VIN CHIC) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-803_912ed4b3-0ad8-4c41-8020-469e753ab147 14783-803 HUMAN OTC DRUG LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20150622 OTC MONOGRAPH FINAL part352 Ventura International LTD AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/mL; g/mL; g/mL; g/mL E 20171231 14783-804_d53107d0-2b40-45aa-a3d6-a2230c93c6bb 14783-804 HUMAN OTC DRUG LBEL LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20150622 OTC MONOGRAPH FINAL part352 Ventura International LTD AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/mL; g/mL; g/mL; g/mL N 20181231 14783-810_cb9315b9-0dd9-4738-82d6-ce8f5813fa5d 14783-810 HUMAN OTC DRUG PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (BEIGE 6) - BROWN OCTINOXATE and OXYBENZONE LOTION TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 14783-811_cb9315b9-0dd9-4738-82d6-ce8f5813fa5d 14783-811 HUMAN OTC DRUG PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (ROSA 1) - PINK OCTINOXATE and OXYBENZONE LOTION TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 14783-812_cb9315b9-0dd9-4738-82d6-ce8f5813fa5d 14783-812 HUMAN OTC DRUG PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (ROSA 2) - PINK OCTINOXATE and OXYBENZONE LOTION TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 14783-813_cb9315b9-0dd9-4738-82d6-ce8f5813fa5d 14783-813 HUMAN OTC DRUG PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (ROSA 3) - PINK OCTINOXATE and OXYBENZONE LOTION TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 14783-814_cb9315b9-0dd9-4738-82d6-ce8f5813fa5d 14783-814 HUMAN OTC DRUG PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (ROSA 4) - PINK OCTINOXATE and OXYBENZONE LOTION TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 14783-815_cb9315b9-0dd9-4738-82d6-ce8f5813fa5d 14783-815 HUMAN OTC DRUG PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (ROSA 5) - PINK OCTINOXATE and OXYBENZONE LOTION TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 14783-816_cb9315b9-0dd9-4738-82d6-ce8f5813fa5d 14783-816 HUMAN OTC DRUG PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (ROSA 6) - PINK OCTINOXATE and OXYBENZONE LOTION TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 14783-817_cb9315b9-0dd9-4738-82d6-ce8f5813fa5d 14783-817 HUMAN OTC DRUG PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (BEIGE 1) - BROWN OCTINOXATE and OXYBENZONE LOTION TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 14783-818_cb9315b9-0dd9-4738-82d6-ce8f5813fa5d 14783-818 HUMAN OTC DRUG PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (BEIGE 2) - BROWN OCTINOXATE and OXYBENZONE LOTION TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 14783-819_cb9315b9-0dd9-4738-82d6-ce8f5813fa5d 14783-819 HUMAN OTC DRUG PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (BEIGE 3) - BROWN OCTINOXATE and OXYBENZONE LOTION TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 14783-820_cb9315b9-0dd9-4738-82d6-ce8f5813fa5d 14783-820 HUMAN OTC DRUG PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (BEIGE 4) - BROWN OCTINOXATE and OXYBENZONE LOTION TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 14783-821_cb9315b9-0dd9-4738-82d6-ce8f5813fa5d 14783-821 HUMAN OTC DRUG PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (BEIGE 5) - BROWN OCTINOXATE and OXYBENZONE LOTION TOPICAL 20150824 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .05; .02 g/mL; g/mL N 20181231 14783-822_f3554855-2b46-4121-8d53-0e44633d736b 14783-822 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (FRESA TENTACION) - RED Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-823_f3554855-2b46-4121-8d53-0e44633d736b 14783-823 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (CAFE MISTERIO) - BROWN Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-824_f3554855-2b46-4121-8d53-0e44633d736b 14783-824 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (ROSA DESEO) - BROWN Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-825_f3554855-2b46-4121-8d53-0e44633d736b 14783-825 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (DURAZNO AMOR) - BROWN Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-826_f3554855-2b46-4121-8d53-0e44633d736b 14783-826 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS -(ROSA GOLOSA) - PINK Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-827_f3554855-2b46-4121-8d53-0e44633d736b 14783-827 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (CORAL SEDUCTOR) - PINK Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-828_f3554855-2b46-4121-8d53-0e44633d736b 14783-828 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (CEREZA SEXY) - PINK Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-829_f3554855-2b46-4121-8d53-0e44633d736b 14783-829 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (FUCSIA SENSUAL) - PINK Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-830_f3554855-2b46-4121-8d53-0e44633d736b 14783-830 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (ROJO PASION) - RED Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-831_f3554855-2b46-4121-8d53-0e44633d736b 14783-831 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (VINO CALIENTE) - PURPLE Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-832_f3554855-2b46-4121-8d53-0e44633d736b 14783-832 HUMAN OTC DRUG ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (PIMIENTA CALIENTE) - RED Octinoxate LIPSTICK TOPICAL 20150828 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .075 g/g N 20181231 14783-833_11ecd0c9-d1b8-42ee-943c-149896bb0623 14783-833 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (FUCSIA) - PINK Octinoxate LIPSTICK TOPICAL 20150831 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .07 g/g E 20171231 14783-834_11ecd0c9-d1b8-42ee-943c-149896bb0623 14783-834 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (CEREZA) - PINK Octinoxate LIPSTICK TOPICAL 20150831 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .07 g/g E 20171231 14783-835_11ecd0c9-d1b8-42ee-943c-149896bb0623 14783-835 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (ROSA) - PINK Octinoxate LIPSTICK TOPICAL 20150831 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .07 g/g E 20171231 14783-836_11ecd0c9-d1b8-42ee-943c-149896bb0623 14783-836 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (RUBI) - PINK Octinoxate LIPSTICK TOPICAL 20150831 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .07 g/g E 20171231 14783-837_11ecd0c9-d1b8-42ee-943c-149896bb0623 14783-837 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (AMBAR) - YELLOW Octinoxate LIPSTICK TOPICAL 20150831 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .07 g/g E 20171231 14783-838_11ecd0c9-d1b8-42ee-943c-149896bb0623 14783-838 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (FRESA) - PINK Octinoxate LIPSTICK TOPICAL 20150831 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .07 g/g E 20171231 14783-839_11ecd0c9-d1b8-42ee-943c-149896bb0623 14783-839 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (CHAMPAGNE) - BEIGE Octinoxate LIPSTICK TOPICAL 20150831 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .07 g/g E 20171231 14783-840_11ecd0c9-d1b8-42ee-943c-149896bb0623 14783-840 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (COBRE) - ORANGE Octinoxate LIPSTICK TOPICAL 20150831 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .07 g/g E 20171231 14783-841_11ecd0c9-d1b8-42ee-943c-149896bb0623 14783-841 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (PIMIENTA CALIENTE) - PINK Octinoxate LIPSTICK TOPICAL 20150831 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .07 g/g E 20171231 14783-842_11ecd0c9-d1b8-42ee-943c-149896bb0623 14783-842 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (DIAMANTE ROSA) - PINK Octinoxate LIPSTICK TOPICAL 20150831 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .07 g/g E 20171231 14783-843_11ecd0c9-d1b8-42ee-943c-149896bb0623 14783-843 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (MELON) - ORANGE Octinoxate LIPSTICK TOPICAL 20150831 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .07 g/g E 20171231 14783-844_11ecd0c9-d1b8-42ee-943c-149896bb0623 14783-844 HUMAN OTC DRUG ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (VINO) - BEIGE Octinoxate LIPSTICK TOPICAL 20150831 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .07 g/g E 20171231 14783-845_477837de-4654-4388-8fba-dda390f71f12 14783-845 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 CLAIRE 1 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-846_477837de-4654-4388-8fba-dda390f71f12 14783-846 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 CLAIRE 2 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-847_477837de-4654-4388-8fba-dda390f71f12 14783-847 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 CLAIRE 3 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-848_477837de-4654-4388-8fba-dda390f71f12 14783-848 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 CLAIRE 4 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-849_477837de-4654-4388-8fba-dda390f71f12 14783-849 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 MEDIUM 5 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-850_477837de-4654-4388-8fba-dda390f71f12 14783-850 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 MEDIUM 6 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-851_477837de-4654-4388-8fba-dda390f71f12 14783-851 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 MEDIUM 7 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-852_477837de-4654-4388-8fba-dda390f71f12 14783-852 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 OBSCURE 8 - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-853_477837de-4654-4388-8fba-dda390f71f12 14783-853 HUMAN OTC DRUG LBEL MOUSSE MATIFFIANT Matte Finish Mousse Foundation SPF 16 Base Textura Mousse Acabado Mate FPS 16 OBSCURE 9 - BROWN Octinoxate, Titanium Dioxide, and Zinc Oxide PASTE TOPICAL 20151120 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .065; .024; .015 g/g; g/g; g/g E 20171231 14783-856_b1538508-0e36-474a-9799-f94d05239102 14783-856 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM CLAIRE 1 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 14783-857_b1538508-0e36-474a-9799-f94d05239102 14783-857 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM CLAIRE 2 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 14783-858_b1538508-0e36-474a-9799-f94d05239102 14783-858 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM CLAIRE 3 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 14783-859_b1538508-0e36-474a-9799-f94d05239102 14783-859 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM CLAIRE 4 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 14783-860_b1538508-0e36-474a-9799-f94d05239102 14783-860 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM MEDIUM 5 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 14783-861_b1538508-0e36-474a-9799-f94d05239102 14783-861 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM MEDIUM 6 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 14783-862_b1538508-0e36-474a-9799-f94d05239102 14783-862 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM MEDIUM 7 - BEIGE Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 14783-863_b1538508-0e36-474a-9799-f94d05239102 14783-863 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM OBSCURE 8 - BROWN Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 14783-864_b1538508-0e36-474a-9799-f94d05239102 14783-864 HUMAN OTC DRUG LBEL EFFET PARFAIT signs of age appearance minimizer foundation SPF 20 FM OBSCURE 9 - BROWN Octinoxate and Titanium Dioxide LOTION TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE .07; .0244 g/mL; g/mL N 20181231 14783-865_94277d00-3c06-4f36-a458-6d5bacdf80d2 14783-865 HUMAN OTC DRUG LBEL EFFET PARFAIT Lip moisturizer SPF 18 FM Hidratante para labios FPS 18 FM Octinoxate, Oxybenzone, and Titanium Dioxide LIPSTICK TOPICAL 20151208 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE .07; .03; .008 g/g; g/g; g/g E 20171231 14783-866_24dd248d-afa4-4948-90bf-07381a67329c 14783-866 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM PECHE - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-867_24dd248d-afa4-4948-90bf-07381a67329c 14783-867 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM SWEET FRAMBOISE - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-868_24dd248d-afa4-4948-90bf-07381a67329c 14783-868 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM DOUCE - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-869_24dd248d-afa4-4948-90bf-07381a67329c 14783-869 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM VIN - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-870_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-870 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE GRANDIOSE) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-871_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-871 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE RUBI) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-872_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-872 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (SOBRIETE) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-873_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-873 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (MARRON ILIMITEE) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-874_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-874 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (CORAL MAXIMUM) - ORANGE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-875_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-875 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROSE TENTATION) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-876_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-876 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROSE CHAMPAGNE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-877_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-877 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROSE DAMOUR) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-878_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-878 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROMANCE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-879_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-879 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (FUCSIA SPLENDIDE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-880_e4b2e969-94ba-46b2-9b07-28df81dd2598 14783-880 HUMAN OTC DRUG LBEL Couleur Luxe Supreme Laque OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20101205 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OXYBENZONE .07; .03 mL/mL; mL/mL E 20171231 14783-881_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-881 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (FUCSIA DESIR) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-882_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-882 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (ROUGE PROVOCATION) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-883_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-883 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (CARMINE) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-884_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-884 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (MALBEC) - BROWN OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-885_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-885 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (SALMON ESSENTIAL) - ORANGE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-886_40ed7e9d-1b75-4c23-a2be-fb6605c51469 14783-886 HUMAN OTC DRUG LBEL EFFET PARFAIT DUAL-USE COMPACT YOUTHFUL LOOKING SKIN SPF7 Titanium Dioxide POWDER TOPICAL 20130916 OTC MONOGRAPH FINAL part352 Ventura International LTD. TITANIUM DIOXIDE .05 g/g E 20171231 14783-887_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-887 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (BOURGOGNE VIF) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-888_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-888 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (GENUINE ROUGE) - RED OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-889_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-889 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (VIOLET VELVET) - PURPLE OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-890_efc91cf8-4e65-494d-a8dc-39fd1d54ffd9 14783-890 HUMAN OTC DRUG EFFET PARFAIT ROUGE AMPLIFIER AMPLIFYING SPF 15 (MYSTIC ROSE) - PINK OCTINOXATE LIPSTICK TOPICAL 20140911 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE .072 g/g E 20171231 14783-891_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-891 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MOKA) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-892_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-892 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROMANCE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-893_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-893 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE NATURAL) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-894_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-894 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROSE CLASIQUE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-895_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-895 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ROUGE INTENSE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-896_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-896 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (AMOUR) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-897_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-897 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHOCOLAT) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-898_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-898 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (ALMOND) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-899_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-899 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MALVE) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-900_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-900 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MARRON GLACE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-901_bfa9d95a-48e7-45c6-ab23-b1f5d92147c3 14783-901 HUMAN OTC DRUG LBEL DEFENSE 365 DAILY PROTECTIVE SPF 50 Octinoxate, Titanium Dioxide, Homosalate, Octisalate, Oxybenzone, and Zinc Oxide LOTION TOPICAL 20141014 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; TITANIUM DIOXIDE; HOMOSALATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .07; .062; .05; .05; .04; .039 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 14783-902_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-902 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TULIP) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-903_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-903 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (LILY BEIGE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-904_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-904 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (MANDARINE) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-905_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-905 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-906_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-906 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TEA ROSE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-907_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-907 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (FRENESIE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-908_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-908 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (RICHE PINK) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-909_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-909 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (RED EXTASSY) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-910_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-910 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (FUCSIA) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-911_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-911 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (SOLEIL) - ORANGE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-912_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-912 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (TERRE) - BROWN OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-913_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-913 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (CHERRY BLOSSOM) - RED OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-914_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-914 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (VIN AMANT) - PURPLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-915_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-915 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE INTIME) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-940_3ecc2159-d00c-4ab8-9354-16bac42fce47 14783-940 HUMAN OTC DRUG EFFET PARFAIT HYDRATESS LONG-LASTING INTENSE MOISTURIZING SPF 20 (NUDE) - PINK OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20140912 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-941_24dd248d-afa4-4948-90bf-07381a67329c 14783-941 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM GRAPE LUMIERE - PINK Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-942_24dd248d-afa4-4948-90bf-07381a67329c 14783-942 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM CARAMEL MELON - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-943_24dd248d-afa4-4948-90bf-07381a67329c 14783-943 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM GROSEILLE - BROWN Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-944_24dd248d-afa4-4948-90bf-07381a67329c 14783-944 HUMAN OTC DRUG LBEL DIVINE LIP GLOSS Lip gloss SPF 15 FM Brillo labial FPS 15 FM VIN SENSUELLE - RED Octinoxate and Oxybenzone LIPSTICK TOPICAL 20151222 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE .075; .03 g/mL; g/mL E 20171231 14783-945_873566cb-f7a0-49c5-9169-9346108b5eb2 14783-945 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 CLAIRE 1- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 14783-946_873566cb-f7a0-49c5-9169-9346108b5eb2 14783-946 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 CLAIRE 2- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 14783-947_873566cb-f7a0-49c5-9169-9346108b5eb2 14783-947 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 CLAIRE 3- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 14783-948_873566cb-f7a0-49c5-9169-9346108b5eb2 14783-948 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 CLAIRE 4- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 14783-949_873566cb-f7a0-49c5-9169-9346108b5eb2 14783-949 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 MEDIUM 5- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 14783-950_873566cb-f7a0-49c5-9169-9346108b5eb2 14783-950 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 MEDIUM 6- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 14783-951_873566cb-f7a0-49c5-9169-9346108b5eb2 14783-951 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 MEDIUM 7- BEIGE Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 14783-952_873566cb-f7a0-49c5-9169-9346108b5eb2 14783-952 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 OBSCURE 8- BROWN Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 14783-953_873566cb-f7a0-49c5-9169-9346108b5eb2 14783-953 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 OBSCURE 9- BROWN Octinoxate, Oxybenzone, and Zinc Oxide SUSPENSION TOPICAL 20160606 OTC MONOGRAPH FINAL part352 Ventura International LTD OCTINOXATE; OXYBENZONE; ZINC OXIDE .075; .02; .0196 g/g; g/g; g/g N 20181231 14783-954_873566cb-f7a0-49c5-9169-9346108b5eb2 14783-954 HUMAN OTC DRUG LBEL CLARITE Clarifying Effect Foundation SPF 30 Octinoxate, Oxybenzone, and Zinc Oxide KIT 20160606 OTC MONOGRAPH FINAL part352 Ventura International LTD N 20181231 14783-955_4edd7434-c886-421b-a78f-092796de2e1d 14783-955 HUMAN OTC DRUG LBEL DRY EFFECT 48 ANTIPERSPIRANT DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE EMULSION TOPICAL 20160705 OTC MONOGRAPH FINAL part350 Ventura International LTD ALUMINUM SESQUICHLOROHYDRATE .18 g/mL E 20171231 14783-956_367326d6-d78d-44da-a93b-c084ced652b4 14783-956 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (CLAIRE 1) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150818 OTC MONOGRAPH FINAL part352 Ventura International LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 14783-957_367326d6-d78d-44da-a93b-c084ced652b4 14783-957 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (CLAIRE 2) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150818 OTC MONOGRAPH FINAL part352 Ventura International LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 14783-958_367326d6-d78d-44da-a93b-c084ced652b4 14783-958 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (CLAIRE 3) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150818 OTC MONOGRAPH FINAL part352 Ventura International LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 14783-959_367326d6-d78d-44da-a93b-c084ced652b4 14783-959 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (CLAIRE 4) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150818 OTC MONOGRAPH FINAL part352 Ventura International LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 14783-960_367326d6-d78d-44da-a93b-c084ced652b4 14783-960 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (MEDIUM 5) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150818 OTC MONOGRAPH FINAL part352 Ventura International LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 14783-961_367326d6-d78d-44da-a93b-c084ced652b4 14783-961 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (MEDIUM 6) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150818 OTC MONOGRAPH FINAL part352 Ventura International LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 14783-962_367326d6-d78d-44da-a93b-c084ced652b4 14783-962 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (MEDIUM 7) - BEIGE Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150818 OTC MONOGRAPH FINAL part352 Ventura International LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 14783-963_367326d6-d78d-44da-a93b-c084ced652b4 14783-963 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (OBSCURE 8) - BROWN Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150818 OTC MONOGRAPH FINAL part352 Ventura International LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 14783-964_367326d6-d78d-44da-a93b-c084ced652b4 14783-964 HUMAN OTC DRUG LBEL EFFET PARFAIT POLVOS COMPACTOS DE LARGA DURACION PARA ROSTRO FPS 15 LONG LASTING COMPACT SPF 15 (OBSCURE 9) - BROWN Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20150818 OTC MONOGRAPH FINAL part352 Ventura International LTD TITANIUM DIOXIDE; ZINC OXIDE .057; .049 g/g; g/g N 20181231 14783-965_d3b30281-4573-4285-a5cd-15751cb6a480 14783-965 HUMAN OTC DRUG LBEL DEFENSE TOTAL broad spectrum SPF 50 plus sunscreen for face and body Avobenzone, Homosalate, and Octocrylene LOTION TOPICAL 20160818 OTC MONOGRAPH FINAL part352 Ventura International LTD AVOBENZONE; HOMOSALATE; OCTOCRYLENE .03; .1; .08 g/mL; g/mL; g/mL N 20181231 14783-971_00fec9ba-6c55-4322-8530-ca6d56917ca6 14783-971 HUMAN OTC DRUG Brightening and moisturizing facial SPF 30 Avobenzone, Ensulizole, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part352 Ventura International LTD AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .03; .05; .05; .06 g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 14783-990_c55866be-7df4-4214-b7c5-3cb3de98d9f2 14783-990 HUMAN OTC DRUG LBEL COULEUR LUXE ROUGE IRRESISTIBLE OCTINOXATE and OXYBENZONE LIPSTICK TOPICAL 20101126 OTC MONOGRAPH NOT FINAL part352 Ventura International, Limited OCTINOXATE; OXYBENZONE .071; .016 g/g; g/g E 20171231 14783-991_d63d4bac-19d6-487f-8f4f-dc01e24bafe3 14783-991 HUMAN OTC DRUG LBEL LEDERM 45 plus JOUR Facial against noticeable signs of aging Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20161024 OTC MONOGRAPH FINAL part352 Ventura International AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .03; .05 g/mL; g/mL; g/mL; g/mL E 20171231 14783-992_e1e17eaf-b424-47e6-be5c-f01a9acba9cf 14783-992 HUMAN OTC DRUG LBEL DEFENSE 365 oil-free daily protective facial SPF 50 Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20161031 OTC MONOGRAPH FINAL part352 Ventura International LTD HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .05; .07; .05; .04; .0624; .0392 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 14785-8117_05dd8b85-f789-4953-b629-53bc9477bd1e 14785-8117 HUMAN OTC DRUG Cold and Hot Medicated Menthol PATCH TOPICAL 20080410 OTC MONOGRAPH NOT FINAL part348 Mentholatum China Pharmaceutical Co. Ltd. MENTHOL 50 mg/1 E 20171231 14785-8123_95bef05e-3aec-4a27-ab4f-24b2567c8305 14785-8123 HUMAN OTC DRUG WellPatch Backache Pain Relief Menthol PATCH TOPICAL 20080118 20190630 OTC MONOGRAPH NOT FINAL part348 Mentholatum China Pharmaceuticals Co Ltd MENTHOL, UNSPECIFIED FORM 50 mg/1 N 20181231 14785-8126_d0268ec9-6850-4c69-b80d-f7b2017725fc 14785-8126 HUMAN OTC DRUG WellPatch Capsaicin Pain Relief Capsaicin PATCH TOPICAL 20080228 20190430 OTC MONOGRAPH NOT FINAL part348 Mentholatum (China) Pharmaceuticals Co Ltd CAPSAICIN .25 mg/1 N 20181231 14789-011_61972ea8-9a94-4748-94ab-358ded59cc9c 14789-011 HUMAN PRESCRIPTION DRUG Isoproterenol Hydrochloride Isoproterenol Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170803 ANDA ANDA206961 Nexus Pharmaceuticals Inc ISOPROTERENOL HYDROCHLORIDE .2 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20181231 14789-012_3718a55c-6a17-478e-a41d-8f605d9534ca 14789-012 HUMAN PRESCRIPTION DRUG Sodium Nitroprusside Sodium Nitroprusside INJECTION INTRAVENOUS 20170529 ANDA ANDA207499 Nexus Pharmaceuticals Inc SODIUM NITROPRUSSIDE 25 mg/mL Vasodilation [PE],Vasodilator [EPC] N 20181231 14789-014_d483665c-4eaf-495f-94ed-c155f5d45f1c 14789-014 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION, SOLUTION INTRAVENOUS 20150608 UNAPPROVED DRUG OTHER Nexus Pharmaceuticals Inc EPHEDRINE SULFATE 50 mg/mL alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE] E 20171231 14789-015_61972ea8-9a94-4748-94ab-358ded59cc9c 14789-015 HUMAN PRESCRIPTION DRUG Isoproterenol Hydrochloride Isoproterenol Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170803 ANDA ANDA206961 Nexus Pharmaceuticals Inc ISOPROTERENOL HYDROCHLORIDE .2 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20181231 14789-300_bbacbb05-2e18-4cf9-b239-6addb60b7533 14789-300 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Injection, USP BENZTROPINE MESYLATE INJECTION PARENTERAL 20090729 ANDA ANDA090233 Nexus Pharmaceuticals Inc BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 14789-500_941ed07d-61f2-4774-8ee6-eafc76c99c5f 14789-500 HUMAN PRESCRIPTION DRUG Tranexamic acid TRANEXAMIC ACID INJECTION, SOLUTION INTRAVENOUS 20120315 ANDA ANDA091596 Nexus Pharmaceuticals Inc TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] E 20171231 14789-900_c500fb74-4285-4756-aa0d-c6da775f72b4 14789-900 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride Procainamide Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20171018 ANDA ANDA206332 Nexus Pharmaceuticals Inc PROCAINAMIDE HYDROCHLORIDE 1000 mg/1 Antiarrhythmic [EPC] N 20181231 14961-001_fed82039-d799-4bb0-80a6-28d9d9de2400 14961-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20050101 NDA NDA205767 Haun Specialty Gases, Inc. OXYGEN 990 L/L N 20181231 14961-003_4a37aab2-d95e-4b82-8db0-2c455efe7cd8 14961-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen LIQUID RESPIRATORY (INHALATION) 20050101 NDA NDA205766 Haun Specialty Gases, Inc. NITROGEN 990 L/L N 20181231 14961-004_3605a89f-b7b9-4d91-ae8f-5bb837796a66 14961-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20050104 NDA NDA205767 Haun Specialty Gases, Inc. OXYGEN 210 mL/L N 20181231 14961-005_4a0b1c79-67a2-4831-b316-5c906a9c6809 14961-005 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 20050104 NDA NDA206826 Haun Specialty Gases, Inc. HELIUM 990 mL/L N 20181231 15014-185_7e3f1f48-49ea-48e6-93c9-7e7a8dedc4ae 15014-185 HUMAN PRESCRIPTION DRUG NuCort Hydrocortisone Acetate LOTION TOPICAL 20100816 UNAPPROVED DRUG OTHER Gentex Pharma HYDROCORTISONE ACETATE 20 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 15054-0043_8d896725-9fc1-48b4-92af-17827bdc663d 15054-0043 HUMAN PRESCRIPTION DRUG Onivyde IRINOTECAN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20151022 NDA NDA207793 Ipsen Biopharmaceuticals, Inc. IRINOTECAN HYDROCHLORIDE 4.3 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 15054-0500_f0cc4070-ca90-4f6f-8846-7f197926e4fc 15054-0500 HUMAN PRESCRIPTION DRUG Dysport Botulinum Toxin Type A INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20091102 BLA BLA125274 Ipsen Biopharmaceuticals, Inc. BOTULINUM TOXIN TYPE A 500 U/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 15054-0530_f0cc4070-ca90-4f6f-8846-7f197926e4fc 15054-0530 HUMAN PRESCRIPTION DRUG Dysport Botulinum Toxin Type A INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20091102 BLA BLA125274 Ipsen Biopharmaceuticals, Inc. BOTULINUM TOXIN TYPE A 300 U/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 15054-1040_29f69973-e6eb-4c41-84c8-53720111f6db 15054-1040 HUMAN PRESCRIPTION DRUG Increlex mecasermin INJECTION, SOLUTION SUBCUTANEOUS 20060103 NDA NDA021839 Ipsen Biopharmaceuticals, Inc. MECASERMIN 40 mg/4mL N 20181231 15054-1060_d6cbf102-1d5a-4a0b-b6e5-f762664c62f7 15054-1060 HUMAN PRESCRIPTION DRUG SOMATULINE DEPOT lanreotide acetate INJECTION SUBCUTANEOUS 20071114 NDA NDA022074 Ipsen Biopharmaceuticals, Inc. LANREOTIDE ACETATE 60 mg/.2mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 15054-1090_d6cbf102-1d5a-4a0b-b6e5-f762664c62f7 15054-1090 HUMAN PRESCRIPTION DRUG SOMATULINE DEPOT lanreotide acetate INJECTION SUBCUTANEOUS 20071114 NDA NDA022074 Ipsen Biopharmaceuticals, Inc. LANREOTIDE ACETATE 90 mg/.3mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 15054-1120_d6cbf102-1d5a-4a0b-b6e5-f762664c62f7 15054-1120 HUMAN PRESCRIPTION DRUG SOMATULINE DEPOT lanreotide acetate INJECTION SUBCUTANEOUS 20071114 NDA NDA022074 Ipsen Biopharmaceuticals, Inc. LANREOTIDE ACETATE 120 mg/.5mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 15062-003_47a46b37-65b4-4699-a4fb-4bd8715619e5 15062-003 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091026 UNAPPROVED MEDICAL GAS Texas Welders Supply Company OXYGEN 996 mL/L E 20171231 15071-604_807982a5-c00f-476e-a20e-3315826756ba 15071-604 HUMAN OTC DRUG Rash Relief Zinc Oxide Dimethicone SPRAY TOPICAL 20050621 OTC MONOGRAPH FINAL part347 Touchless Care Concepts LLC ZINC OXIDE; DIMETHICONE 25; 20 g/100g; g/100g E 20171231 15071-652_129b5c74-29e9-4827-a58a-47b5a9cac8e8 15071-652 HUMAN OTC DRUG Rash Relief Silver Dimethicone Zinc Oxide LIQUID TOPICAL 20081101 OTC MONOGRAPH FINAL part347 Touchless Care Concepts LLC DIMETHICONE; ZINC OXIDE 20; 25 g/100g; g/100g E 20171231 15071-672_24e155fd-dad7-4d37-a12d-0c18fc624481 15071-672 HUMAN OTC DRUG Rash Relief Antibacterial Bacitracin Dimethicone Zinc Oxide LIQUID TOPICAL 20060614 OTC MONOGRAPH FINAL part333B Touchless Care Concepts LLC BACITRACIN; DIMETHICONE; ZINC OXIDE 500; 20; 25 [iU]/g; g/100g; g/100g E 20171231 15071-704_f678f128-0e58-49db-a47d-21ab8f8c74a3 15071-704 HUMAN OTC DRUG Rash Relief Clear Petrolatum Dimethicone LIQUID TOPICAL 20050621 OTC MONOGRAPH FINAL part347 Touchless Care Concepts LLC PETROLATUM; DIMETHICONE 25; 20 g/100g; g/100g E 20171231 15071-804_2d4f02ce-0bf1-4f31-9eb8-ee649af17ec2 15071-804 HUMAN OTC DRUG Rash Relief Antifungal Miconazole LIQUID TOPICAL 20060614 OTC MONOGRAPH FINAL part333C Touchless Care Concepts LLC MICONAZOLE NITRATE; DIMETHICONE; ZINC OXIDE 2; 10; 10 g/100g; g/100g; g/100g E 20171231 15127-000_4a435290-f288-4f91-b731-4c0a6d60950b 15127-000 HUMAN OTC DRUG Select Brand Sunscreen OCTINOXATE, OXYBENZONE LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 Select Brand Distributors OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g N 20181231 15127-001_a9280d60-1ebb-4a34-af95-e9a3b86715dd 15127-001 HUMAN OTC DRUG Select Brand Sport Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part352 Select Brand Distributors AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 15127-002_b3b33a6e-ec28-4c64-ac57-da170dec6eb3 15127-002 HUMAN OTC DRUG Select Brand Burn Relief LIDOCAINE HCL GEL TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part348 Select Brand Distributors LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 15127-003_44e0a3f5-32be-4e8a-9cfd-a9d61ad89737 15127-003 HUMAN OTC DRUG Select Brand Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121120 OTC MONOGRAPH NOT FINAL part352 Select Brand Distributors AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 15127-004_821a79d3-9937-447d-aa4f-e08312760acd 15127-004 HUMAN OTC DRUG Select Brand Baby Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121120 OTC MONOGRAPH NOT FINAL part352 Select Brand Distributors AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 15127-005_4060203f-9a89-487d-b9ad-c80cf8053697 15127-005 HUMAN OTC DRUG Select Brand Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 Select Brand Distributors AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 15127-006_4614cd61-d4b4-4df5-8ea4-3bd0514e7e55 15127-006 HUMAN OTC DRUG Select Brand Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part352 Select Brand Distributors AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 15127-007_122e566d-aa4c-4083-9451-4d4222fbf330 15127-007 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A Select Brand Distributors ALCOHOL 70 mL/100mL N 20181231 15127-010_6a5c5f24-1ba7-4038-90aa-af80e1bef419 15127-010 HUMAN OTC DRUG Womens Gentle Laxative Bisacodyl TABLET, COATED ORAL 20000901 20181214 OTC MONOGRAPH NOT FINAL part334 L&R Distributors, Inc. BISACODYL 5 mg/1 E 20171231 15127-012_c0e1c52f-5c9c-4c96-a1d2-8bb14442b2de 15127-012 HUMAN OTC DRUG Childrens Dibromm Cold and Allergy Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Select Brand Dist. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/10mL; mg/10mL N 20181231 15127-013_4daec9c2-8db6-57d0-e054-00144ff88e88 15127-013 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20130508 OTC MONOGRAPH FINAL part341 L & R Distributors, Inc. MENTHOL 5.4 mg/1 N 20181231 15127-014_4db2857b-8e29-564f-e054-00144ff88e88 15127-014 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20151020 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. MENTHOL 5.8 mg/1 N 20181231 15127-015_4db28298-2932-47dd-e054-00144ff8d46c 15127-015 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20150911 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. MENTHOL 7.5 mg/1 N 20181231 15127-016_4db388ef-6614-6703-e054-00144ff8d46c 15127-016 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20120405 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. MENTHOL 5.8 mg/1 N 20181231 15127-018_14f6b96d-9e3f-45b2-99b0-1721bc7d1cc2 15127-018 HUMAN OTC DRUG Allergy Medicine Diphenhydramine HCl TABLET, FILM COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 15127-033_06c458fc-22de-623a-e054-00144ff88e88 15127-033 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20100816 OTC MONOGRAPH FINAL part341 Select Brand ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 15127-042_0f3c6d9c-2054-42b3-820b-dd2d32e6fe3c 15127-042 HUMAN OTC DRUG Infants Gas Relief Drops simethicone EMULSION ORAL 20130202 OTC MONOGRAPH FINAL part332 Select Brand DIMETHICONE 20 mg/.3mL N 20181231 15127-050_715ab5b0-12b5-4e9a-af74-8764838bf87d 15127-050 HUMAN OTC DRUG Allerfed Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20050722 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 15127-052_602c8d13-0fd4-8143-e053-2a91aa0acb3a 15127-052 HUMAN OTC DRUG Select Brand Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Select Brand Distributors POVIDONE-IODINE 100 mg/mL N 20181231 15127-054_0bc49507-4263-3f8d-e054-00144ff88e88 15127-054 HUMAN OTC DRUG Select Brand Itch Relief Diphenhydramine Hydrochloride and Zinc Acetate SPRAY TOPICAL 20120711 OTC MONOGRAPH FINAL part347 Select Brand DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE .2; .01 g/10mL; g/10mL N 20181231 15127-055_0c2b8c34-67bb-3ae9-e054-00144ff8d46c 15127-055 HUMAN OTC DRUG Select Brand Extra Strength Itch Stopping Diphenhydramine Hydrochloride GEL TOPICAL 20120711 OTC MONOGRAPH NOT FINAL part348 Select Brand DIPHENHYDRAMINE HYDROCHLORIDE .2 g/10mL N 20181231 15127-069_e2645545-3f62-4ad7-8203-883cba3464b9 15127-069 HUMAN OTC DRUG Petrolatum White Petrolatum JELLY TOPICAL 20090313 OTC MONOGRAPH FINAL part347 Select Brand Distributors PETROLATUM 1 g/g N 20181231 15127-072_817bc36d-5263-401c-ae41-4ba5c1b5bd9b 15127-072 HUMAN OTC DRUG Pain Reliever Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN 325 mg/1 N 20181231 15127-081_5ae5cece-504b-463f-9543-d00c155aca74 15127-081 HUMAN OTC DRUG PSEUDO-FREE PE Maximum Strength, Non-Drowsy Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 15127-082_2081b229-beb6-4e0d-af55-40fac0933d17 15127-082 HUMAN OTC DRUG Sinus and Allergy Chlorpheniramine Maleate and Phenylephrine HCl TABLET ORAL 20050615 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 15127-085_70fc42cd-b4eb-43f6-be1d-f8b5644b5942 15127-085 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM Adult Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Select Brand Dist. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 15127-088_be085738-b4fe-484f-8949-da2f026f49bd 15127-088 HUMAN OTC DRUG Pain Reliever Childrens Acetaminophen SUSPENSION ORAL 20150331 OTC MONOGRAPH NOT FINAL part343 Select Brand Dist. ACETAMINOPHEN 160 mg/5mL N 20181231 15127-090_42226f34-1791-4c69-8f75-17740f4bd3a5 15127-090 HUMAN OTC DRUG Lidocaine Burn Relief AEROSOL, SPRAY TOPICAL 20171226 OTC MONOGRAPH NOT FINAL part348 SELECT BRAND DISTRIBUTORS LIDOCAINE .64 g/127g N 20181231 15127-091_210ae5ab-fbb3-499b-8e7e-1ea3c0777832 15127-091 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20171226 OTC MONOGRAPH FINAL part333C SELECT BRANDS DISTRIBUTORS MICONAZOLE NITRATE 2.6 g/130g N 20181231 15127-092_36b0d1b5-2244-4a59-b049-efa5d1a8e318 15127-092 HUMAN OTC DRUG Salicylic Acid One Step Wart Remover Clear Strips PLASTER TOPICAL 20140218 OTC MONOGRAPH FINAL part358B SELECT BRANDS DISTRIBUTORS SALICYLIC ACID 40 mg/141 N 20181231 15127-093_2dcb3bab-e660-494b-9b94-52de63f6ce7f 15127-093 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20171226 OTC MONOGRAPH NOT FINAL part333A SELECT BRAND DISTRIBUTORS BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/9mL; mg/9mL N 20181231 15127-094_ece452c8-3c76-4de3-b54f-7654b624ceed 15127-094 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20171226 OTC MONOGRAPH FINAL part358B SELECT BRANDS DISTRIBUTORS SALICYLIC ACID .17 mg/9.8mL N 20181231 15127-095_fb96814a-0a25-4deb-8414-031e20cb1501 15127-095 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid LIQUID TOPICAL 20171227 OTC MONOGRAPH FINAL part358B SELECT BRANDS DISTRIBUTORS SALICYLIC ACID .17 mg/9mL N 20181231 15127-096_2ee0ff28-7405-4d0b-8c9e-be395d69b972 15127-096 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20171227 OTC MONOGRAPH FINAL part358F SELECT BRAND DISTRIBUTORS SALICYLIC ACID 40 mg/41 N 20181231 15127-097_9af7332c-f746-493d-baa9-295a2e600df4 15127-097 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20171227 OTC MONOGRAPH FINAL part333C SELECT BRANDS DISTRIBUTORS TOLNAFTATE 1.5 g/150g N 20181231 15127-098_3ef4127f-b27a-4875-a35a-21afb8d101b2 15127-098 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20171227 OTC MONOGRAPH FINAL part333C SELECT BRANDS DISTRIBUTORS TOLNAFTATE 1.3 g/130g N 20181231 15127-105_9480268c-da3e-4ab3-b972-f0520496221f 15127-105 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 L&R Distributors, Inc. SENNOSIDES 8.6 mg/1 N 20181231 15127-115_467c35ec-3063-4a34-a7f6-c9a6f8b392dd 15127-115 HUMAN OTC DRUG Select Brand Earwax Removal Drops CARBAMIDE PEROXIDE LIQUID TOPICAL 20141128 OTC MONOGRAPH FINAL part344 Stephen L. LaFrance Pharmacy, Inc. CARBAMIDE PEROXIDE 65 mg/mL N 20181231 15127-122_f1fb18a2-46b8-42e1-bc67-f808ccff0786 15127-122 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate OINTMENT TOPICAL 20050923 OTC MONOGRAPH FINAL part333B L&R Distributors, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 15127-127_c36079e0-6522-4c1b-b3e3-c2841ce4e014 15127-127 HUMAN OTC DRUG Hydrocortisone With Aloe Maximum Strength Hydrocortisone CREAM TOPICAL 20050923 OTC MONOGRAPH NOT FINAL part348 L&R Distributors, Inc. HYDROCORTISONE 1 g/100g N 20181231 15127-128_b5f9ab08-6b2d-4ef6-a194-69b2724b9644 15127-128 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone OINTMENT TOPICAL 20080513 OTC MONOGRAPH NOT FINAL part348 L&R Distributors, Inc. HYDROCORTISONE 1 g/100g N 20181231 15127-129_6bf19556-aebc-4a05-bd55-0a59254e92dc 15127-129 HUMAN OTC DRUG Select Brand Mucus Relief Guaifenesin TABLET ORAL 20140926 OTC MONOGRAPH FINAL part341 Select Brand Distributors GUAIFENESIN 200 mg/1 N 20181231 15127-138_2c4c19d5-705e-4e5e-81bb-e1400cfad21d 15127-138 HUMAN OTC DRUG Select Brand Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20140926 UNAPPROVED DRUG OTHER Select Brand Distributors PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 15127-139_74bd46e1-2a68-4280-860e-0987bd708804 15127-139 HUMAN OTC DRUG Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20141030 OTC MONOGRAPH FINAL part341 Select Brand Dist. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 15127-140_59d14c82-f3cc-4d99-bd58-c42cdd4c69b4 15127-140 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20060201 OTC MONOGRAPH NOT FINAL part348 L&R Distributors, Inc. HYDROCORTISONE 1 g/100g N 20181231 15127-151_c59fcb7a-6b60-4e85-a020-2c65b7ebe284 15127-151 HUMAN OTC DRUG Select Brand Coughtab 400 Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Select Brand Distributors GUAIFENESIN 400 mg/1 N 20181231 15127-157_ce268749-fcb6-4d84-85ad-50952d06c30c 15127-157 HUMAN OTC DRUG gas relief simethicone TABLET, CHEWABLE ORAL 20090202 OTC MONOGRAPH FINAL part332 Select Brand DIMETHICONE 125 mg/1 N 20181231 15127-168_50eb6a06-9337-49a0-bc2a-46c4d4e9074e 15127-168 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20160630 ANDA ANDA079096 Select Brand Dist. NAPROXEN SODIUM 220 mg/1 N 20181231 15127-170_77f0990c-df64-42f6-b291-889049944454 15127-170 HUMAN OTC DRUG Select Brand Mucus Relief DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Select Brand Distributors DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 15127-171_4ce95bba-0bd7-4ee0-96c2-9d9887ec445c 15127-171 HUMAN OTC DRUG Select Brand Mucus Relief PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Select Brand Distributors GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 15127-178_9ff8f193-5e2f-4381-93da-2256a1e4d207 15127-178 HUMAN OTC DRUG Laxative Bisacodyl TABLET, SUGAR COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 L&R Distributors, Inc. BISACODYL 5 mg/1 N 20181231 15127-184_06c458fc-231c-623a-e054-00144ff88e88 15127-184 HUMAN OTC DRUG Severe Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120306 OTC MONOGRAPH FINAL part341 Select Brand ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 15127-185_d5723743-b65a-4142-9391-f396c15333d1 15127-185 HUMAN OTC DRUG Pain Reliever Children Acetaminophen TABLET, CHEWABLE ORAL 20010906 20200829 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN 80 mg/1 N 20181231 15127-207_f8dc6d0f-a563-4b9a-b373-53e490b06e87 15127-207 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20090202 OTC MONOGRAPH FINAL part331 Select Brand CALCIUM CARBONATE 750 mg/1 N 20181231 15127-210_520d029a-5b8a-4bfe-9ef4-c7eb378cb4c2 15127-210 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20081212 OTC MONOGRAPH FINAL part331 Select Brand CALCIUM CARBONATE 500 mg/1 N 20181231 15127-211_db8374db-0a7e-471f-8760-411a2da55d7b 15127-211 HUMAN OTC DRUG Antacid calcium carbonate TABLET, CHEWABLE ORAL 20081212 OTC MONOGRAPH FINAL part331 Select Brand CALCIUM CARBONATE 500 mg/1 N 20181231 15127-212_e80cf9bb-b8b9-46ce-b835-5d512d2b85b7 15127-212 HUMAN OTC DRUG Select Brand Antacid Assorted Berries Calcium carbonate TABLET, CHEWABLE ORAL 20081212 OTC MONOGRAPH FINAL part331 Select Brand CALCIUM CARBONATE 750 mg/1 N 20181231 15127-226_a9215f33-8546-4107-9d29-bfc61c6f07fa 15127-226 HUMAN OTC DRUG Stay Alert Alertness Aid Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 L&R Distributors, Inc. CAFFEINE 200 mg/1 N 20181231 15127-227_35e7d83b-2905-41ac-88ca-1ddd27461f68 15127-227 HUMAN OTC DRUG ENTERIC COATED ASPIRIN Regular Strength Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ASPIRIN 325 mg/1 N 20181231 15127-228_a98af280-8dd3-4b6b-a937-ffebaeaa85ba 15127-228 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ASPIRIN 81 mg/1 N 20181231 15127-241_f5a75d83-8253-46dc-a7ab-0da72d2d4025 15127-241 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ASPIRIN 81 mg/1 N 20181231 15127-258_ce74b5cd-8933-4322-b966-50cc9cdc615b 15127-258 HUMAN OTC DRUG Sleep Tabs Diphenhydramine HCl TABLET ORAL 19900410 OTC MONOGRAPH FINAL part338 L&R Distributors, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 15127-261_4dcc3f12-cedb-428c-8bea-ff23e76669fd 15127-261 HUMAN OTC DRUG Anti-Itch Extra Strength diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20060410 OTC MONOGRAPH NOT FINAL part348 L&R Distributors, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20191231 15127-262_0e73ba44-17fe-4ed8-bf90-ad5c66f38d57 15127-262 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 L&R Distributors, Inc. DIMENHYDRINATE 50 mg/1 N 20181231 15127-268_f190a88b-eca1-4dcf-8c40-f1d57e4e0cca 15127-268 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate and Dextromethorphan Hydrobromide TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 15127-277_54efe8e5-3eda-4ed1-8d9e-b6c4b17b1751 15127-277 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20060802 OTC MONOGRAPH NOT FINAL part333A Select Brand Dist. ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 15127-281_c5dab90d-521b-4067-bd82-fc5b2f0fdc01 15127-281 HUMAN OTC DRUG Pain Reliever Childrens Acetaminophen SUSPENSION ORAL 20150331 OTC MONOGRAPH NOT FINAL part343 Select Brand Dist. ACETAMINOPHEN 160 mg/5mL N 20181231 15127-283_6552a8f9-6712-45c5-8cf4-fa8e53a12f39 15127-283 HUMAN OTC DRUG Allergy Medicine Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 15127-288_43448fd1-b4f4-4b86-9da7-993dc232908c 15127-288 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 19950912 20180727 OTC MONOGRAPH NOT FINAL part334 L&R Distributors, Inc. DOCUSATE SODIUM 100 mg/1 E 20171231 15127-291_dba3eb3e-3271-4f45-aa8d-cfde9ceb96a7 15127-291 HUMAN OTC DRUG Select Brand Anti-Nausea phosphorated carbohydrate SOLUTION ORAL 20080101 UNAPPROVED DRUG OTHER Select Brand Distributors SUCROSE; PHOSPHORIC ACID 3.74; 21.5 g/5mL; mg/5mL N 20181231 15127-292_c5205b56-0f0b-45aa-8a9f-1fc4edbe58a7 15127-292 HUMAN OTC DRUG Childrens Allergy Diphenhydramine HCl LIQUID ORAL 20151231 OTC MONOGRAPH FINAL part341 Select Brand Dist. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 15127-304_6a9c0685-f66a-4fc2-a204-b09245f344f2 15127-304 HUMAN OTC DRUG 12 Hour Nasal oxymetazoline HCl SPRAY NASAL 20000301 OTC MONOGRAPH FINAL part341 Select Brand Distributors OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 15127-309_043bd56c-1a14-4d53-8b82-c4c6d15800cd 15127-309 HUMAN OTC DRUG Cough Relief Adult Dextromethorphan HBr LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Select Brand Dist. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 15127-311_d2ecb04f-b572-40ef-8ca2-ec886c9c0b54 15127-311 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090115 OTC MONOGRAPH FINAL part358H Select Brand Distributors PYRITHIONE ZINC 1 kg/100L N 20181231 15127-312_11826ef8-3ebf-4e0a-9e91-03fedc7d2ce1 15127-312 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 L&R Distributors, Inc. IBUPROFEN 200 mg/1 N 20181231 15127-316_bb8b47b5-2d16-4f98-8b9b-59a736f8c7fe 15127-316 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100313 ANDA ANDA078682 Select Brand Dist. IBUPROFEN 200 mg/1 N 20181231 15127-318_3a0e78a4-fa5a-4282-ab23-73e16e3c39ac 15127-318 HUMAN OTC DRUG Antispetic Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 19911209 OTC MONOGRAPH NOT FINAL part356 Select Brand Distributors EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 15127-319_db84bde1-f132-44cd-a105-9af17efc886c 15127-319 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate TABLET, CHEWABLE ORAL 19980716 OTC MONOGRAPH FINAL part335 L&R Distributors, Inc. BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 15127-322_fc4f1e30-c079-42fc-b654-c8e0e0a37f1e 15127-322 HUMAN OTC DRUG Pain Reliever Infants Acetaminophen SUSPENSION ORAL 20151130 OTC MONOGRAPH NOT FINAL part343 Select Brand Dist. ACETAMINOPHEN 160 mg/5mL N 20181231 15127-324_6c56f908-5eff-4480-b4e0-d9fd7adcab20 15127-324 HUMAN OTC DRUG Pain Relief Infants Acetaminophen SUSPENSION ORAL 20150630 OTC MONOGRAPH NOT FINAL part343 Select Brand Dist. ACETAMINOPHEN 160 mg/5mL N 20181231 15127-325_5ca4723f-6acc-4150-8983-4ac9a5f0ce01 15127-325 HUMAN OTC DRUG Pain Reliever PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 15127-326_f0eddf47-989d-4d56-bf88-31b00ea7cead 15127-326 HUMAN OTC DRUG Magnesium Citrate Cherry Magnesium citrate LIQUID ORAL 20061003 OTC MONOGRAPH NOT FINAL part334 Select Brand Dist. MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 15127-329_9bc1c233-81a6-4945-93f0-710ac6e568b1 15127-329 HUMAN OTC DRUG Magnesium Citrate Lemon Magnesium citrate SOLUTION ORAL 20060626 OTC MONOGRAPH NOT FINAL part334 Select Brand Dist. MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 15127-332_52cde4d1-9930-4d53-9c28-2dcc281867d2 15127-332 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Select Brand ACETAMINOPHEN 650 mg/1 N 20181231 15127-334_002b2a41-aa4b-41ce-9b3a-6656fed08955 15127-334 HUMAN OTC DRUG Mineral oil Mineral oil OIL ORAL 20090925 OTC MONOGRAPH NOT FINAL part334 Select Brand Dist. MINERAL OIL 100 mg/100mL N 20181231 15127-335_a0ad9740-14d9-4fd2-abe2-5bcd4c3ec5df 15127-335 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 L&R Distributors, Inc. IBUPROFEN 200 mg/1 N 20181231 15127-338_e887e062-0b65-4612-b0bf-ea04f01cdbdb 15127-338 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Select Brand LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 15127-340_9d228d53-a9ff-4391-8395-77580924fc26 15127-340 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20120330 ANDA ANDA200536 Select Brand RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 15127-343_252b90b9-14c3-42c4-acd0-444c3344c011 15127-343 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20161031 OTC MONOGRAPH FINAL part341 Select Brand Dist. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 15127-344_6407aa3e-cf39-437c-a8a4-7acb719d5891 15127-344 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20161031 OTC MONOGRAPH FINAL part341 Select Brand Dist. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 15127-346_0ef199f0-ea71-46b1-9a4a-841a72803ef6 15127-346 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 Select Brand Dist. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 15127-370_14f9b3e4-d31d-4e20-a402-a2c84d11a3f1 15127-370 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20120213 ANDA ANDA090283 Select Brand FAMOTIDINE 10 mg/1 N 20181231 15127-371_0bc5f6c2-90bd-6930-e054-00144ff88e88 15127-371 HUMAN OTC DRUG Select Brand Medicated Vaporizing Steam camphor (synthetic) LIQUID RESPIRATORY (INHALATION) 20111102 OTC MONOGRAPH FINAL part341 Select Brand CAMPHOR (SYNTHETIC) .623 g/10mL N 20181231 15127-372_7c219528-3d0c-4ee6-a863-2856d0eab89e 15127-372 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20150131 OTC MONOGRAPH FINAL part335 Select Brand Dist. BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 15127-375_374e7b74-8eba-48e2-abaf-9fd6031fea2f 15127-375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 L&R Distributors, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 15127-382_9049fc22-2caa-4ff4-9269-4fbe3018a40b 15127-382 HUMAN OTC DRUG Tussin Multi Symptom Cold CF Adult Dextromethorphan HBr, Guaifenesin, Phenylephrine LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Select Brand Dist. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 15127-384_5bd56b8c-b04e-4be7-b119-86c3dd3d7eaa 15127-384 HUMAN OTC DRUG Adult Tussin Cough and Chest Congestion DM Sugar Free Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Select Brand Dist. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 15127-385_769d15b1-55a8-45b3-b554-b50b9fa30bfb 15127-385 HUMAN OTC DRUG Allergy Severe Acetaminophen and Diphenhydramine HCl TABLET ORAL 20050606 20180610 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 12.5 mg/1; mg/1 E 20171231 15127-389_3389d36f-62b7-423f-bdad-b5a77f4caafa 15127-389 HUMAN OTC DRUG Tussin Mucus and Chest Congestion Adult Guaifenesin LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Select Brand Dist. GUAIFENESIN 200 mg/10mL N 20181231 15127-412_77e133af-2ef9-41a8-b9dc-be50fb65413c 15127-412 HUMAN OTC DRUG Tussin CF Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Select Brand Dist. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 15127-413_5e0926f8-a022-ffd9-e053-2991aa0a41e4 15127-413 HUMAN OTC DRUG Select Brand Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Select Brand Distributors ZINC OXIDE 160 mg/mL N 20181231 15127-425_5cb3edb4-34af-4297-b281-83ddfb3e3b26 15127-425 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part335 Select Brand Dist. BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 15127-448_cfb33be0-1867-41be-bd4c-19bb83213c03 15127-448 HUMAN OTC DRUG Backache Aid Magnesium Salicylate TABLET, FILM COATED ORAL 19981107 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. MAGNESIUM SALICYLATE 580 mg/1 N 20191231 15127-452_6e4a05c3-0277-4e40-a943-b15d0a549620 15127-452 HUMAN OTC DRUG Blue Ice Analgesic Gel Menthol GEL TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part348 Select Brand Distributors MENTHOL 2 g/100g E 20171231 15127-466_84eb107d-e81b-48d3-8231-9816b8158457 15127-466 HUMAN OTC DRUG Day Time Cold and Flu non drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Select Brand Dist. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 15127-470_6a440624-588f-492b-8fa9-28e169816ae3 15127-470 HUMAN OTC DRUG Select Brand Tab Tussin Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Select Brand Distributors GUAIFENESIN 400 mg/1 N 20181231 15127-471_da4e21a7-1939-4de2-9b07-d76f81899410 15127-471 HUMAN OTC DRUG Select Brand Tab Tussin DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Select Brand Distributors DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 15127-503_21b0e8bf-3ec5-4ed3-a113-ad3ae6da7c48 15127-503 HUMAN OTC DRUG Cold and Flu Severe Acetaminophen, Phenylephrine HCl, Guaifenesin, Dextromethorphan HBr TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 325; 5; 200; 10 mg/1; mg/1; mg/1; mg/1 N 20181231 15127-508_e055b032-2d7a-48d0-82c4-df4812f55c57 15127-508 HUMAN OTC DRUG Childrens Pain Reliever Acetaminophen SUSPENSION ORAL 20140805 OTC MONOGRAPH NOT FINAL part343 Select Brand Dist. ACETAMINOPHEN 160 mg/5mL N 20181231 15127-549_0c7fdea9-6f7d-4177-83c6-61fe85d8e20f 15127-549 HUMAN OTC DRUG Laxative Pills Sennosides PILL ORAL 20081212 OTC MONOGRAPH NOT FINAL part334 Select Brand SENNOSIDES 25 mg/1 N 20181231 15127-590_e9531111-f98c-495e-84a3-9b7275e93edb 15127-590 HUMAN OTC DRUG Select Brand Hemorrhoid Glycerin, Petrolatum, Phenylephrine Hydrochloride, Pramoxine Hydrochloride CREAM RECTAL 20140301 OTC MONOGRAPH FINAL part346 L&R Distributors, Inc. GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 144; 150; 2.5; 10 mg/g; mg/g; mg/g; mg/g N 20191231 15127-594_6e1edfa9-a684-4e91-a311-ce064ea4d36a 15127-594 HUMAN OTC DRUG Sleep Aid Nighttime Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 L&R Distributors, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 15127-595_540773ad-b4ef-48e1-925f-3061fbcf4a6f 15127-595 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140430 OTC MONOGRAPH FINAL part338 Select Brand Dist. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 15127-655_0cc04906-8620-49ee-b455-e9b9e5db010b 15127-655 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH NOT FINAL part334 L&R Distributors, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 15127-659_2483d717-feb2-4b0a-b057-1d5a6c932d18 15127-659 HUMAN OTC DRUG Cold and Flu Non-Drowsy, Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 15127-660_b85aa7bc-d368-4b45-8d34-879d28681a1a 15127-660 HUMAN OTC DRUG Cold and Flu Nighttime Multi Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 15127-661_4a3fb159-4170-45f1-8762-9bffe06fe717 15127-661 HUMAN OTC DRUG Cough Control Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 15127-671_75595457-3e00-42e8-8704-4f94d212fb7d 15127-671 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part335 Select Brand Dist. BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 15127-676_715f1a72-9102-48ef-9a94-933f13bdc1d2 15127-676 HUMAN OTC DRUG Gentle Laxative Womens Bisacodyl TABLET, COATED ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 L&R Distributors, Inc. BISACODYL 5 mg/1 N 20181231 15127-680_0bc2cddc-2876-09cc-e054-00144ff88e88 15127-680 HUMAN OTC DRUG Select Brand Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20101028 OTC MONOGRAPH FINAL part358G Select Brand PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 15127-686_5c72bfd7-26ad-4ea5-8dcf-8be9ead812e8 15127-686 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20110310 OTC MONOGRAPH NOT FINAL part334 Select Brand Distributors MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 15127-689_bb4d77da-d6ae-4236-9c3c-03286d3b7567 15127-689 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphane HBr TABLET, FILM COATED ORAL 20170331 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 15127-693_d83920dd-fb2c-4dc4-a09f-4feb0337ec0f 15127-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19931004 OTC MONOGRAPH NOT FINAL part334 Select Brands distributors MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 15127-711_2b36b3a0-e2a7-4db3-ba87-965e7c8f3086 15127-711 HUMAN OTC DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Select Brand RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 15127-715_73e2a4b3-c024-4b6a-8a92-519df6c3f202 15127-715 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Select Brand LORATADINE 10 mg/1 N 20181231 15127-717_22389ba2-a1fe-4ea1-98a0-b08aa4179eb0 15127-717 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Select Brand LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 15127-721_0bacd190-b119-0df3-e054-00144ff8d46c 15127-721 HUMAN OTC DRUG Select Brand Anti-Itch Menthol and Pramoxine Hydrochloride CREAM TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part348 Select Brand PRAMOXINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM .1; .1 g/10g; g/10g N 20181231 15127-730_f0da780e-6c6c-4526-b3c0-66081ad3b5d2 15127-730 HUMAN OTC DRUG Extra Strength Non-Aspirin Pain Reliever Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 15127-735_b69d071f-dfea-4702-a67a-a570cc48f766 15127-735 HUMAN OTC DRUG Pain Reliever Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 15127-738_7fcc31eb-7ac2-4677-9704-d6ba3f8ad121 15127-738 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ASPIRIN 325 mg/1 N 20181231 15127-804_aeecd5b0-bf5e-47fb-a022-247afbe75ad7 15127-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20110310 OTC MONOGRAPH NOT FINAL part333A Select Brand Distributors ISOPROPYL ALCOHOL .91 mg/mL N 20181231 15127-806_a6737672-6196-4b22-84f5-2bcb031fe5f9 15127-806 HUMAN OTC DRUG Cough Control DM Sugar Free Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100908 OTC MONOGRAPH FINAL part341 Select Brand Dist. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 15127-807_61b2e6ed-87ad-4f3d-b009-6891b08e5690 15127-807 HUMAN OTC DRUG Acetaminophen Extra Strength Rapid Burst Cherry Acetaminophen LIQUID ORAL 20100908 OTC MONOGRAPH NOT FINAL part343 Select Brand Dist. ACETAMINOPHEN 500 mg/15mL N 20181231 15127-821_34138fe6-ae9a-4792-9741-5734b77e7f5b 15127-821 HUMAN OTC DRUG Chlorpheniramine Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 15127-822_5c4f0f69-4f8a-40f2-a249-cb8fc2f563c5 15127-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20110310 OTC MONOGRAPH FINAL part346 Select Brands WITCH HAZEL 86 kg/100L N 20181231 15127-831_906b0b29-93da-4f53-9de4-de69fcbef91a 15127-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19931025 OTC MONOGRAPH NOT FINAL part334 Select Brand MINERAL OIL 999 mg/mL N 20181231 15127-857_18b524f9-d3dd-42e5-a376-1d87e110ef5f 15127-857 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 15127-862_0335131d-c09d-437e-9d05-7ae7811cb284 15127-862 HUMAN OTC DRUG Flu and Sore Throat Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20100908 OTC MONOGRAPH FINAL part341 Select Brand Dist. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 15127-864_5712c2ad-704f-4d29-8e62-a069f9bfa027 15127-864 HUMAN OTC DRUG Cough Control DM Max dextromethorphan HBr, guaifenesin LIQUID ORAL 20100908 OTC MONOGRAPH FINAL part341 Select Brand Dist. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL N 20181231 15127-871_dbaf4b1f-4147-4c2d-a6a1-4ec2dd6df290 15127-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20110921 OTC MONOGRAPH NOT FINAL part333A Select Brand Distributors HYDROGEN PEROXIDE 30 mg/mL N 20181231 15127-872_6f4739fd-b57b-4279-8406-363b44eaad9f 15127-872 HUMAN OTC DRUG Smooth texture Orange flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20100404 OTC MONOGRAPH NOT FINAL part334 Select Brand PSYLLIUM HUSK 3.4 g/12g N 20181231 15127-874_8c40255a-0391-4309-831e-14537e59c2d5 15127-874 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ASPIRIN 81 mg/1 N 20181231 15127-877_c2fb3b18-7816-4091-807f-4a68d5dd8a53 15127-877 HUMAN OTC DRUG Pain Reliever Junior Strength Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN 160 mg/1 N 20181231 15127-881_ced569cd-571f-4f29-9048-90aa2e3c69f1 15127-881 HUMAN OTC DRUG Night Time Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20131206 OTC MONOGRAPH FINAL part341 Select Brand Dist. DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 15127-891_1713ddfd-a6f0-410f-bc5b-30f9bcf561d7 15127-891 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION ORAL 20091002 20181031 ANDA ANDA079058 L&R Distributors, Inc. IBUPROFEN 50 mg/1.25mL N 20181231 15127-898_266e4886-5ca3-479d-a8d8-a6abb576e232 15127-898 HUMAN OTC DRUG Pain Reliever Extra Strength PM Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 15127-900_ce134440-2817-4b4f-96dd-546745d7a914 15127-900 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080213 20180731 ANDA ANDA074916 L&R Distributors, Inc. IBUPROFEN 100 mg/5mL N 20181231 15127-901_848afbf3-b80a-4b9d-8cfc-d6cc251c7083 15127-901 HUMAN OTC DRUG Cold and Flu Daytime Nighttime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate KIT 20070919 20180727 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. E 20171231 15127-902_2c7acb52-fc1f-40f9-8a36-79bf990ffe61 15127-902 HUMAN OTC DRUG Daytime/Nighttime Cold and Flu Multi-Symptom Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate KIT 20150301 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. N 20191231 15127-905_e9ac2bd7-e4d2-4b53-8234-de469c6ba7a3 15127-905 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020330 ANDA ANDA075139 L&R Distributors, Inc. IBUPROFEN 200 mg/1 N 20181231 15127-907_bcf74678-aeb4-4010-bce9-b9f590d62b93 15127-907 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 L&R Distributors, Inc. IBUPROFEN 200 mg/1 N 20181231 15127-909_f37b9fdc-9610-429f-bed4-d74893eda296 15127-909 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Select Brand CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 15127-919_f964ffba-bc68-4dfa-ae09-4edfa61438b1 15127-919 HUMAN OTC DRUG Hydrocortisone Plus 12 Moisturizers Maximum Strength Hydrocortisone CREAM TOPICAL 20100405 OTC MONOGRAPH NOT FINAL part348 L&R Distributors, Inc. HYDROCORTISONE 1 g/100g N 20181231 15127-922_4a237ae1-1063-4c5c-9e7b-e129e539515e 15127-922 HUMAN OTC DRUG Flu Relief Therapy Nighttime Severe Cold Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20111228 OTC MONOGRAPH FINAL part341 Select Brand Dist. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 15127-923_192f751f-90b7-492d-b2cd-81216bd3b6bb 15127-923 HUMAN OTC DRUG Flu Relief Therapy Daytime Severe Cold ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20070822 OTC MONOGRAPH FINAL part341 Select Brand Dist. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 15127-927_b601e051-879c-475a-a456-c9b11c4a8f42 15127-927 HUMAN OTC DRUG Cold Multi-Symptom Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Chlorpheniramine maleate KIT ORAL 20050721 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. N 20181231 15127-931_61ec4820-771f-4915-8373-06b643aecb59 15127-931 HUMAN OTC DRUG Childrens Plus Multi Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride SUSPENSION ORAL 20130510 OTC MONOGRAPH FINAL part341 Select Brand Dist. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 15127-933_bac25e08-dbda-48d5-b339-2c51ae12868f 15127-933 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20050726 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. N 20181231 15127-938_d842048d-53d7-416e-bcec-d43a478052da 15127-938 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 15127-950_c90fc981-3bcf-4f8e-97fc-5679c6710e44 15127-950 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide SUSPENSION ORAL 20130521 OTC MONOGRAPH FINAL part341 Select Brand Dist. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 15127-953_1a50fdc4-7fa3-4cff-b01f-22e50a98416c 15127-953 HUMAN OTC DRUG Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl ELIXIR ORAL 20141003 OTC MONOGRAPH FINAL part341 Select Brand Dist. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 15127-954_79df2e83-6fc6-4d0b-98d0-cc326bbd59ad 15127-954 HUMAN OTC DRUG Childrens Cold and Allergy Brompheniramine maleate, Phenylephrine HCl ELIXIR ORAL 20110711 OTC MONOGRAPH FINAL part341 Select Brand Dist. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL N 20181231 15127-955_0c40d932-b31c-4da3-ae13-d9b6ae7c507f 15127-955 HUMAN OTC DRUG antacid Calcium carbonate TABLET, CHEWABLE ORAL 20081212 OTC MONOGRAPH FINAL part331 Select Brand CALCIUM CARBONATE 1000 mg/1 N 20181231 15127-957_14d663c9-fbc6-4ef6-acdb-fbd3a664662e 15127-957 HUMAN OTC DRUG Cold and Flu BP Acetaminophen and Chlorpheniramine Maleate TABLET, COATED ORAL 20050531 20180604 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 325; 2 mg/1; mg/1 E 20171231 15127-958_5ac91f80-bd07-4f76-bc90-c820dce028bf 15127-958 HUMAN OTC DRUG Flu BP Maximum Strength Acetaminophen, Chlorpheniramine maleate and Dextromethorphan HBr TABLET, FILM COATED ORAL 20050601 20191025 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 500; 2; 15 mg/1; mg/1; mg/1 E 20171231 15127-962_9e891f84-771f-4acf-86d6-7cfced996d55 15127-962 HUMAN OTC DRUG Cold Multi-Symptom Severe Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Guaifenesin TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 15127-963_2e2153f4-95fb-45d1-afd5-fe5f320fa2ef 15127-963 HUMAN OTC DRUG Sinus Congestion and Pain Severe Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 15127-964_a60abefa-2892-4226-aa49-3e640d28939e 15127-964 HUMAN OTC DRUG Cold Head Congestion Severe Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl and Guaifenesin TABLET, FILM COATED ORAL 20060622 20190126 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 15127-965_8895292e-6dc3-4516-85c5-f18f015c7019 15127-965 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen and Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 15127-966_d1feb1c8-23a7-4506-a979-3e93b8ae1dc8 15127-966 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20050628 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 15127-967_8bee3072-42d3-4e0c-96c1-4a36dcfde3b4 15127-967 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20050628 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 15127-968_38d13846-3bb0-4e2b-ad24-052cf9ddc4f1 15127-968 HUMAN OTC DRUG Pain Relief Fast Relief Aspirin, Citric Acid Monohydrate, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20061023 OTC MONOGRAPH FINAL part343 Select Brand ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 E 20171231 15127-972_e16ede14-25aa-4aa5-b8fb-bd182ba0dffe 15127-972 HUMAN OTC DRUG Pain Reliever Extra Strength Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 15127-973_06c458fc-2307-623a-e054-00144ff88e88 15127-973 HUMAN OTC DRUG Allergy and Cold PE ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20081009 OTC MONOGRAPH FINAL part341 Select Brand ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 15127-974_06c458fc-22f2-623a-e054-00144ff88e88 15127-974 HUMAN OTC DRUG Severe Cold PE Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20080924 OTC MONOGRAPH FINAL part341 Select Brand ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 15127-978_ce134440-2817-4b4f-96dd-546745d7a914 15127-978 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060525 20180930 ANDA ANDA074916 L&R Distributors, Inc. IBUPROFEN 100 mg/5mL N 20181231 15127-979_a90cd258-ffa6-44e9-aaa0-04bdae94487e 15127-979 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Select Brand LORATADINE 10 mg/1 N 20181231 15127-984_4eff0877-de14-44ab-84d7-ee0d69245133 15127-984 HUMAN OTC DRUG Cough Control Dextromethorphan HBr CAPSULE, GELATIN COATED ORAL 20060424 20180827 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 E 20171231 15127-985_d8f75d1f-f02d-4483-9bb4-3223cb010564 15127-985 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE ORAL 20070910 20180727 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 E 20171231 15127-987_cddc82b9-6e75-42f8-a6f1-78bb82b74625 15127-987 HUMAN OTC DRUG Nighttime Cold and Flu Cherry Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20131206 OTC MONOGRAPH FINAL part341 Select Brand Dist. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 15127-989_e2adaac2-30c8-4690-828c-ee5dcad30441 15127-989 HUMAN OTC DRUG Cold and Flu Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070919 20180727 OTC MONOGRAPH FINAL part341 L&R Distributors, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 15127-994_5e68cce1-7960-4f46-b52b-714512ac263a 15127-994 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 L&R Distributors, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 15187-004_493ea01e-aa58-4f68-909e-031defb2338e 15187-004 HUMAN OTC DRUG Scot-Tussin Original Multi-Symptom Cold and Allergy Relief Acetominophen, Phenylephrine Hydrochloride and Pheniramine Maleate LIQUID ORAL 20160101 OTC MONOGRAPH FINAL part341 IriSys, LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; PHENIRAMINE MALEATE 160; 4; 4 mg/5mL; mg/5mL; mg/5mL N 20181231 15187-006_d93daa2a-2c8d-46fb-a259-55a3ef44ed3b 15187-006 HUMAN OTC DRUG Scot-Tussin Expectorant Cough Guaifenesin LIQUID ORAL 20160101 OTC MONOGRAPH FINAL part341 IriSys, LLC GUAIFENESIN 100 mg/5mL N 20181231 15187-036_882b1cf4-b14d-424c-9b83-de2924d2565c 15187-036 HUMAN OTC DRUG Scot-Tussin DM Maximum Strength Cough Suppressant and Cold Relief chlorpheniramine maleate and dextromethorphan hydrobromide LIQUID ORAL 20160101 OTC MONOGRAPH FINAL part341 IriSys, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 2; 15 mg/5mL; mg/5mL N 20181231 15187-043_f2fb890d-df88-4612-836d-13bfc55d7d56 15187-043 HUMAN OTC DRUG Scot-Tussin Diabetes Cough Formula with DM dextromethorphan hydrobromide LIQUID ORAL 20160101 OTC MONOGRAPH FINAL part341 IriSys, LLC DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL N 20181231 15187-050_2a0044b3-1b7e-4c01-b9aa-2438c6d2c658 15187-050 HUMAN OTC DRUG Scot-Tussin Senior Maximum Strength Cough Suppressant and Expectorant Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 20160101 OTC MONOGRAPH FINAL part341 IriSys, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 15; 200 mg/5mL; mg/5mL N 20181231 15197-007_b6537332-c86e-4fec-8d8b-568f387277c4 15197-007 HUMAN OTC DRUG Bodyglide anti chafe balm Allantoin STICK TOPICAL 20091124 OTC MONOGRAPH FINAL part347 W STERNOFF LLC ALLANTOIN 5 mg/g E 20171231 15197-008_7f61b268-213a-469d-9014-4cfcf1346779 15197-008 HUMAN OTC DRUG Chamois Glide Allantoin STICK TOPICAL 20091124 OTC MONOGRAPH FINAL part347 W STERNOFF LLC ALLANTOIN 5 mg/g E 20171231 15197-009_6f13950d-4373-49f7-9faf-5de9ec64b0cf 15197-009 HUMAN OTC DRUG Bodyglide For Her Allantoin STICK TOPICAL 20091124 OTC MONOGRAPH FINAL part347 W STERNOFF LLC ALLANTOIN 5 mg/g E 20171231 15231-100_add7f0ba-bb4c-4538-bedc-b1ab76c9199b 15231-100 HUMAN OTC DRUG ETHYL RUBBING ALCOHOL ALCOHOL LIQUID CUTANEOUS 19980209 OTC MONOGRAPH NOT FINAL part333E COMERCIALIZADORA JIQUILPAN S.A. DE C.V. ALCOHOL 70 mL/100mL E 20171231 15231-200_1d89190f-e872-5aea-e054-00144ff88e88 15231-200 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID CUTANEOUS 20150817 OTC MONOGRAPH NOT FINAL part333A COMERCIALIZADORA JIQUILPAN S.A. DE C.V. ISOPROPYL ALCOHOL 350 mL/500mL E 20171231 15240-0001_2861685a-0f67-4b70-9f58-bb7f4566c0aa 15240-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20051005 UNAPPROVED MEDICAL GAS Community Oxygen Services OXYGEN 99 L/100L E 20171231 15304-4085_e80dad36-53a2-4d36-96b0-fd12192cd74b 15304-4085 HUMAN OTC DRUG Mastic Dent Sodium Fluoride, Eucalyptol, Thymol and Menthol MOUTHWASH DENTAL; ORAL 20051122 OTC MONOGRAPH NOT FINAL part356 Chia Gi LTD SODIUM FLUORIDE; EUCALYPTOL; THYMOL; MENTHOL .25; .92; .64; .42 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 15304-4182_3bf69e68-a5be-40b4-9f36-668ac750e0cd 15304-4182 HUMAN OTC DRUG Mastic Dent Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20051122 OTC MONOGRAPH FINAL part355 Chia Gi LTD SODIUM FLUORIDE 2.2 mg/mL E 20171231 15304-4681_ca4990dc-9be6-44e4-9a67-fb0eb0682b2f 15304-4681 HUMAN OTC DRUG Mastic Dent Oulo Action Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20051122 OTC MONOGRAPH FINAL part355 Chia Gi LTD SODIUM FLUORIDE 2.2 mg/mL E 20171231 15310-010_c716eae8-b9a9-4a5d-b153-79898f8ad9af 15310-010 HUMAN PRESCRIPTION DRUG EEMT ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE TABLET, COATED ORAL 20110901 UNAPPROVED DRUG OTHER CREEKWOOD PHARMACEUTICAL, INC, ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE 1.25; 2.5 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 15310-020_c716eae8-b9a9-4a5d-b153-79898f8ad9af 15310-020 HUMAN PRESCRIPTION DRUG EEMT HS ESTROGENS, ESTERIFIED and METHYLTESTOSTERONE TABLET, COATED ORAL 20110901 UNAPPROVED DRUG OTHER CREEKWOOD PHARMACEUTICAL, INC, ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 15338-100_b3fa8d62-cec4-416b-b979-56a945423ae1 15338-100 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 Apace Packaging LLC DOXYCYCLINE HYCLATE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 15338-122_8a9c319f-f300-3f89-5276-116410b86a26 15338-122 HUMAN PRESCRIPTION DRUG Klor-Con M10 Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20000809 ANDA ANDA074726 Apace Packaging LLC POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 15338-133_8a9c319f-f300-3f89-5276-116410b86a26 15338-133 HUMAN PRESCRIPTION DRUG Klor-Con M20 Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20000809 ANDA ANDA074726 Apace Packaging LLC POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 15338-150_31999703-3b31-4820-9319-1e5675c1ad82 15338-150 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20091206 NDA NDA070033 Apace Packaging METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 15338-170_3a1b39df-bc52-4ad7-87f6-ea77cac706f2 15338-170 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091223 NDA NDA080680 Apace Packaging FOLIC ACID 1 mg/1 N 20181231 15338-600_40c97a84-32b2-49cf-8c00-b2485b4e9d5f 15338-600 HUMAN PRESCRIPTION DRUG Belladonna Alkaloids with Phenobartbital Belladonna Alkaloids with Phenobartbital TABLET ORAL 20001201 UNAPPROVED DRUG OTHER Apace Packaging ATROPINE SULFATE; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; PHENOBARBITAL .0194; .1037; .0065; 16.2 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 15343-104_d577c12a-e6b8-4660-ada0-2b62cf8e852a 15343-104 HUMAN OTC DRUG Prime Asthma Relief Epinephrine KIT 20140821 OTC MONOGRAPH FINAL part341 DRNATURALHEALING E 20171231 15343-105_d577c12a-e6b8-4660-ada0-2b62cf8e852a 15343-105 HUMAN OTC DRUG PRIME ASTHMA RELIEF EPINEPHRINE CAPSULE RESPIRATORY (INHALATION) 20140821 OTC MONOGRAPH FINAL part341 DRNATURALHEALING EPINEPHRINE .22 mg/1 E 20171231 15343-125_b547f151-e318-4301-948a-696825bfb00e 15343-125 HUMAN OTC DRUG Epi-Mist RACEPINEPHRINE HYDROCHLORIDE AEROSOL, SPRAY RESPIRATORY (INHALATION) 20150515 OTC MONOGRAPH FINAL part341 DRNATURALHEALING INC RACEPINEPHRINE HYDROCHLORIDE .594 mg/.12mL E 20171231 15370-100_967ee6d0-2450-4fd9-ac7a-992f0ff69b71 15370-100 HUMAN PRESCRIPTION DRUG Quflora Pediatric Drops VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE LIQUID ORAL 20140715 UNAPPROVED DRUG OTHER CarWin Pharmaceutical Associates, LLC VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; CYANOCOBALAMIN; MAGNESIUM OXIDE; CUPRIC SULFATE; SODIUM FLUORIDE 1000; 35; 400; 5; .5; .6; .8; .4; 35; 2; 10; 1; .25 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 15370-101_1db30c36-f26f-48b2-bcf8-060aede3258f 15370-101 HUMAN PRESCRIPTION DRUG Quflora Pediatric Drops VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE LIQUID ORAL 20140715 UNAPPROVED DRUG OTHER CarWin Pharmaceutical Associates, LLC VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; CYANOCOBALAMIN; MAGNESIUM OXIDE; CUPRIC SULFATE; SODIUM FLUORIDE 1100; 45; 400; 12; 1; 1; 2; 1; 81; 3; 12; 1; .5 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 15370-102_a843f709-c7ea-456b-8bdc-48901d1fd2d2 15370-102 HUMAN PRESCRIPTION DRUG Quflora FE Pediatric Drops VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PANTOTHENIC ACID, PYRIDOXINE HYDROCHLORIDE, BIOTIN, LEVOMEFOLATE GLUCOSAMINE, CYANOCOBALAMIN, FERROUS SULFATE, and SODIUM FLUORIDE LIQUID ORAL 20170421 UNAPPROVED DRUG OTHER Carwin Pharmaceutical Associates, LLC VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; BIOTIN; LEVOMEFOLATE GLUCOSAMINE; CYANOCOBALAMIN; FERROUS SULFATE; SODIUM FLUORIDE 1500; 36; 400; 5; .5; .6; 4; 1; .4; 3; 37.5; 2; 9.5; .25 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 15370-103_dbb224b6-9a41-403d-98e5-de06ffd782c8 15370-103 HUMAN PRESCRIPTION DRUG Quflora Pediatric VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20140106 UNAPPROVED DRUG OTHER CarWin Pharmaceutical Associates, LLC VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; MAGNESIUM OXIDE; CUPRIC SULFATE; SODIUM FLUORIDE 1200; 60; 400; 15; 1.2; 1.3; 5; 1.5; 108; 100; 4; 15; 1; .25 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1 Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 15370-104_dbb224b6-9a41-403d-98e5-de06ffd782c8 15370-104 HUMAN PRESCRIPTION DRUG Quflora Pediatric VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20140106 UNAPPROVED DRUG OTHER CarWin Pharmaceutical Associates, LLC VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; MAGNESIUM OXIDE; CUPRIC SULFATE; SODIUM FLUORIDE 1200; 60; 400; 15; 1.2; 1.3; 5; 1.5; 108; 100; 4; 15; 1; .5 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 15370-105_dbb224b6-9a41-403d-98e5-de06ffd782c8 15370-105 HUMAN PRESCRIPTION DRUG Quflora Pediatric VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20140106 UNAPPROVED DRUG OTHER CarWin Pharmaceutical Associates, LLC VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; MAGNESIUM OXIDE; CUPRIC SULFATE; SODIUM FLUORIDE 1200; 60; 400; 15; 1.2; 1.3; 5; 1.5; 108; 100; 4; 15; 1; 1 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 15370-110_b1c39371-c657-41d7-9110-4af33245037a 15370-110 HUMAN OTC DRUG PediaVent DEXBROMPHENIRAMINE MALEATE SYRUP ORAL 20140804 OTC MONOGRAPH FINAL part341 CarWin Pharmaceutical Associates, LLC DEXBROMPHENIRAMINE MALEATE 2 mg/5mL N 20181231 15370-112_ba4c3759-8540-4ccf-a18c-043eae719702 15370-112 HUMAN OTC DRUG PediaVent DEXBROMPHENIRAMINE MALEATE TABLET, CHEWABLE ORAL 20140805 OTC MONOGRAPH FINAL part341 CarWin Pharmaceutical Associates, LLC DEXBROMPHENIRAMINE MALEATE 1 mg/1 N 20181231 15370-130_13ed76c7-49bd-4527-83dc-b4c7d0da9fff 15370-130 HUMAN PRESCRIPTION DRUG RyVent carbinoxamine maleate TABLET ORAL 20170217 ANDA ANDA207484 Carwin Pharmaceutical Associates, LLC CARBINOXAMINE MALEATE 6 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 15370-140_e9f7c794-e2a8-4e30-9344-42152d001e80 15370-140 HUMAN OTC DRUG ATUSS DA CHLOPHEDIANOL HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, and BROMPHENIRAMINE MALEATE LIQUID ORAL 20161025 OTC MONOGRAPH FINAL part341 Carwin Pharmaceutical Associates, LLC CHLOPHEDIANOL HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 12.5; 30; 2 mg/5mL; mg/5mL; mg/5mL N 20181231 15370-250_80999e4b-a99b-4abd-b082-0ac6febebb1d 15370-250 HUMAN PRESCRIPTION DRUG TriStart DHA ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, and ICOSAPENT CAPSULE, LIQUID FILLED ORAL 20150601 UNAPPROVED DRUG OTHER CarWin Pharmaceutical Associates, LLC ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE MAGNESIUM; FOLIC ACID; CYANOCOBALAMIN; IRON PENTACARBONYL; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; ICOSAPENT 55; 1000; 15; 1.3; 1.8; 5; 35; 600; 400; 14; 31; 200; 30; 200; 15 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 15370-265_c5222dfd-a466-4b73-b103-c3ebf8f7777c 15370-265 HUMAN PRESCRIPTION DRUG NuFera ASCORBIC ACID, CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, and IRON PENTACARBONYL TABLET ORAL 20151216 UNAPPROVED DRUG OTHER CarWin Pharmaceutical Associates, LLC ASCORBIC ACID; CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE MAGNESIUM; FOLIC ACID; CYANOCOBALAMIN; IRON PENTACARBONYL 170; 1000; 15; 600; 400; 16; 125 mg/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 15377-002_9162ac36-62de-4d2c-bf16-c84045016264 15377-002 HUMAN OTC DRUG Neuragen PN Aconitum napellus, Hypericum perforatum, Lycopodium clavatum, Phosphorus, Rhus toxicodendron, Secale cornutum SOLUTION TOPICAL 20050801 UNAPPROVED HOMEOPATHIC Origin Biomed Inc HYPERICUM PERFORATUM; ACONITUM NAPELLUS; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM 12; 12; 12; 12; 12; 12 [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL E 20171231 15377-006_10554f30-db0e-4db4-a95a-936c40654e16 15377-006 HUMAN OTC DRUG Neuragen Pain Relief Hypericum, Aconitum Napellus, Lycopodium, Phosphorus, Rhus Toxicodendron GEL TOPICAL 20090501 UNAPPROVED HOMEOPATHIC Origin Biomed Inc HYPERICUM PERFORATUM; ACONITUM NAPELLUS; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM 12; 12; 12; 12; 12; 12 [hp_C]/8g; [hp_C]/8g; [hp_C]/8g; [hp_C]/8g; [hp_C]/8g; [hp_C]/8g E 20171231 15377-008_99127436-1f0a-4bca-8ed1-17707cd0efad 15377-008 HUMAN OTC DRUG Walgreens Nerve Pain Relief Aconitum Napellus, Hypericum Perforatum, Lycopodium clavatum, Phosphorus, Rhus Toxicodendron, Secale Cornutum SOLUTION TOPICAL 20100820 UNAPPROVED HOMEOPATHIC Origin Biomed Inc. ACONITUM NAPELLUS; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM 12; 12; 12; 12; 12; 12 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL E 20171231 15377-010_9ba499c2-c23e-481d-9fa9-8862f043887a 15377-010 HUMAN OTC DRUG Neuragen Pain Relief Aconitum napellus, Hypericum perforatum, Lycopodium clavatum, Phosphorus, Rhus toxicodendron, Secale cornutum CREAM TOPICAL 20110801 UNAPPROVED HOMEOPATHIC Origin Biomed Inc. ACONITUM NAPELLUS; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM; PHOSPHORUS 12; 12; 12; 12; 12; 12 [hp_C]/113g; [hp_C]/113g; [hp_C]/113g; [hp_C]/113g; [hp_C]/113g; [hp_C]/113g E 20171231 15377-012_db8c3872-fe84-46af-b155-9952d9154926 15377-012 HUMAN OTC DRUG Bionica Pain Relieving Gel Arnica, Belladonna, Bellis, Bryonia, Cuprum Acet, Cuprum Sulph, Calendula, Hypericum, Ledum, Rhus Tox, Ruta, Symphytum, Sulphuricum Ac, Calc Fluor, Calc Phos, Calch Sulph, Ferrum Phos, Kali Sulph, Mag Phos, Nat Mur, Nat Phos, Nat Sulphuricum GEL TOPICAL 20131003 UNAPPROVED HOMEOPATHIC Origin BioMed Inc. ARNICA MONTANA FLOWER; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CUPRIC ACETATE; CUPRIC SULFATE; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; SULFURIC ACID; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM SULFATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 30; 30; 30; 12; 12; 12; 12; 30; 12; 30; 30; 12; 6; 12; 10; 6; 12; 6; 6; 6; 30; 12; 12; 6 [hp_C]/85g; [hp_C]/85g; [hp_C]/85g; [hp_C]/85g; [hp_X]/85g; [hp_X]/85g; [hp_C]/85g; [hp_C]/85g; [hp_C]/85g; [hp_C]/85g; [hp_C]/85g; [hp_X]/85g; [hp_X]/85g; [hp_C]/85g; [hp_X]/85g; [hp_X]/85g; [hp_C]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_C]/85g; [hp_C]/85g; [hp_X]/85g; [hp_X]/85g E 20171231 15408-002_bf8375c1-c254-4451-9940-d38070bd4cdf 15408-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Westair Gas & Equipment, LLC NITROGEN 990 mL/L E 20171231 15455-0112_252e44fa-5f9f-1a7a-e054-00144ff88e88 15455-0112 HUMAN PRESCRIPTION DRUG Equipto - Amitriptyline External Cream Compounding Kit Amitriptyline KIT TOPICAL 20150120 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-0610_2564b15a-a516-427c-e054-00144ff88e88 15455-0610 HUMAN PRESCRIPTION DRUG Equipto - Naproxen External Cream Compounding Kit Naproxen KIT TOPICAL 20150120 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-0701_25581be0-23f6-4767-e054-00144ff88e88 15455-0701 HUMAN PRESCRIPTION DRUG Equipto - Baclofen External Cream Compounding Kit Baclofen KIT TOPICAL 20150120 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-0717_23239a86-1128-5377-e054-00144ff88e88 15455-0717 HUMAN PRESCRIPTION DRUG Gapeam Budibac Amantadine HCl, Baclofen, Bupivacaine HCl, Cyclobenzaprine HCl, Diclofenac Sodium, Gabapentin, and Pentoxifylline KIT TOPICAL 20141205 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-7566_25f3fa1d-4355-47db-e054-00144ff88e88 15455-7566 HUMAN PRESCRIPTION DRUG Dipentocaine Topical Cream Compounding Kit Diclofenac Sodium, Gabapentin, and Lidocaine Hydrochloride KIT TOPICAL 20141106 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-9001_1f71d479-9c32-18ac-e054-00144ff88e88 15455-9001 HUMAN PRESCRIPTION DRUG DyNAmic Kit Medicated DNA Sampling Kit KIT ORAL; TOPICAL 20150417 ANDA ANDA040014 Alvix Laboratories, LLC E 20171231 15455-9002_25df3b5b-ddd9-17b8-e054-00144ff88e88 15455-9002 HUMAN PRESCRIPTION DRUG Specimen Collection Kit Speciment Collection Kit KIT ORAL 20150421 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-9006_1b495ec8-aa5e-63a8-e054-00144ff8d46c 15455-9006 STANDARDIZED ALLERGENIC ALLERGEN PACK BERMUDA GRASS allergen pack bermuda grass KIT INTRADERMAL; SUBCUTANEOUS 20150701 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-9007_1b70b3a9-16ea-4644-e054-00144ff8d46c 15455-9007 NON-STANDARDIZED ALLERGENIC ALLERGEN PACK DOG EPITHELIA Allergen Pack Dog Epithelia KIT INTRADERMAL; SUBCUTANEOUS 20150720 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC. N 20181231 15455-9008_1b70b3a9-16e7-4644-e054-00144ff8d46c 15455-9008 NON-STANDARDIZED ALLERGENIC ALLERGEN PACK AMERICAN COCKROACH Allergen Pack American Cockroach KIT INTRADERMAL; SUBCUTANEOUS 20150722 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC. N 20181231 15455-9009_1a6a2362-cd10-67e3-e054-00144ff8d46c 15455-9009 STANDARDIZED ALLERGENIC ALLERGEN PACK CAT DANDER ALLERGEN PACK CAT DANDER SOLUTION INTRADERMAL; SUBCUTANEOUS 20150709 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] N 20181231 15455-9010_1a7dc03f-71e7-04db-e054-00144ff8d46c 15455-9010 STANDARDIZED ALLERGENIC ALLERGEN PACK TIMOTHY GRASS allergen pack timothy grass SOLUTION INTRADERMAL; SUBCUTANEOUS 20150709 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC PHLEUM PRATENSE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 15455-9011_1b70b3a9-16f3-4644-e054-00144ff8d46c 15455-9011 NON-STANDARDIZED ALLERGENIC ALLERGEN PACK JOHNSON GRASS Allergen Pack Johnson Grass KIT INTRADERMAL; SUBCUTANEOUS 20150720 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC. N 20181231 15455-9012_1a6b8f09-449f-0900-e054-00144ff88e88 15455-9012 STANDARDIZED ALLERGENIC ALLERGEN PACK GS RAGWEED MIX ALLERGEN PACK GS RAGWEED MIX KIT INTRADERMAL; SUBCUTANEOUS 20150709 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-9013_1b70b3a9-16f8-4644-e054-00144ff8d46c 15455-9013 NON-STANDARDIZED ALLERGENIC ALLERGEN PACK MOUNTAIN CEDAR Allergen Pack Mountain Cedar KIT INTRADERMAL; SUBCUTANEOUS 20150722 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC. N 20181231 15455-9014_1b481583-ffa3-23ba-e054-00144ff8d46c 15455-9014 NON-STANDARDIZED ALLERGENIC ALLERGEN PACK POST OAK Allergen Pack Post Oak KIT INTRADERMAL; SUBCUTANEOUS 20150720 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC. N 20181231 15455-9015_1b714f6c-e08a-143f-e054-00144ff88e88 15455-9015 NON-STANDARDIZED ALLERGENIC ALLERGEN PACK EASTERN COTTONWOOD Allergen Pack Eastern Cottonwood KIT INTRADERMAL; SUBCUTANEOUS 20150720 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC. N 20181231 15455-9016_1b714f6c-e08f-143f-e054-00144ff88e88 15455-9016 NON-STANDARDIZED ALLERGENIC ALLERGEN PACK AMERICAN ELM Allergen Pack American Elm KIT INTRADERMAL; SUBCUTANEOUS 20150722 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC. N 20181231 15455-9017_1b5bf9c5-189c-4f6a-e054-00144ff88e88 15455-9017 STANDARDIZED ALLERGENIC ALLERGEN PACK DERMATOPHAGOIDES FARINAE ALLERGEN PACK DERMATOPHAGOIDES FARINAE KIT INTRADERMAL; SUBCUTANEOUS 20150721 BLA BLA101834 Alvix Laboratories, LLC N 20181231 15455-9018_1b49b08b-848e-3f71-e054-00144ff88e88 15455-9018 STANDARDIZED ALLERGENIC ALLERGEN PACK DERMATOPHAGOIDES PTERONYSSINUS ALLERGEN PACK DERMATOPHAGOIDES PTERONYSSINUS SOLUTION INTRADERMAL; SUBCUTANEOUS 20150625 BLA BLA101835 Alvix Laboratories, LLC DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 15455-9019_19c790f6-3c15-4b28-e054-00144ff8d46c 15455-9019 STANDARDIZED ALLERGENIC ALLERGEN PACK ASPERGILLUS FUMIGATUS Allergen Pack Aspergillus Fumigatus SOLUTION INTRADERMAL; SUBCUTANEOUS 20150626 BLA BLA101833 Alvix Laboratories, LLC ASPERGILLUS FUMIGATUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 15455-9020_1b7074fb-627e-745f-e054-00144ff88e88 15455-9020 STANDARDIZED ALLERGENIC ALLERGEN PACK ALTERNARIA TENUIS Allergen Pack Alternaria tenuis KIT INTRADERMAL; SUBCUTANEOUS 20150722 BLA BLA101833 Alvix Laboratories, LLC N 20181231 15455-9504_5f4c576f-cc61-ec7d-e053-2991aa0ad164 15455-9504 HUMAN PRESCRIPTION DRUG LIVIXIL PAK lidocaine 2.5% and prilocaine 2.5% KIT TOPICAL 20150722 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-9526_62744381-f746-712e-e053-2991aa0afcd6 15455-9526 HUMAN PRESCRIPTION DRUG CidalEaze Lidocaine Hydrochloride CREAM TOPICAL 20150811 20180930 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC LIDOCAINE HYDROCHLORIDE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 15455-9527_25932820-cfc2-4400-e054-00144ff8d46c 15455-9527 HUMAN PRESCRIPTION DRUG LP Lite PAK lidocaine 2.5% and prilocaine 2.5% KIT TOPICAL 20150910 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-9528_5cb68e27-184e-1595-e053-2991aa0a13ea 15455-9528 HUMAN PRESCRIPTION DRUG AgonEaze lidocaine 2.5% and prilocaine 2.5% KIT TOPICAL 20160112 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-9551_24ffbf1a-ab99-548f-e054-00144ff8d46c 15455-9551 HUMAN PRESCRIPTION DRUG DS Prep PAK Diclofenac Sodium Topical Gel 1% with Gloves and Anticeptic Wipes KIT TOPICAL 20151120 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-9552_5d2158e8-385a-e63c-e053-2991aa0ab97f 15455-9552 HUMAN PRESCRIPTION DRUG RRB Pak Betamethasone Dipropionate Cream and Ross Ru Skin Discontinuities KIT TOPICAL 20151212 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-9553_5cb68e27-18c3-1595-e053-2991aa0a13ea 15455-9553 HUMAN PRESCRIPTION DRUG DyNAmic Plus Pak Kit Medicated DNA Sampling Kit, Urine Specimen Collection Kit KIT BUCCAL; TOPICAL 20151209 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-9557_5cb68e27-187c-1595-e053-2991aa0a13ea 15455-9557 HUMAN PRESCRIPTION DRUG Infla-eze Diclofenac Sodium Topical Gel 1% with Gloves and Anticeptic Wipes KIT TOPICAL 20160111 UNAPPROVED DRUG OTHER Alvix Laboratories, LLC N 20181231 15455-9565_12dd097b-f199-4a63-bbba-3d52ac54fa3c 15455-9565 HUMAN PRESCRIPTION DRUG DST Plus Pak diclofenac sodium and benzalkonium chloride KIT 20160902 NDA NDA022122 Alvix Laboratories, LLC N 20181231 15478-003_1b161612-e50f-413f-a7e2-4764a6f9ad79 15478-003 HUMAN OTC DRUG Throat-Releev (Honey and Lemon) Benzalkonium Chloride LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333A Topical Pharmaceuticals Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 15478-004_f2f8e83d-5bfe-4dc5-bf79-afd18965b833 15478-004 HUMAN OTC DRUG Throat-Releev (Cherry and Pomegranate) Benzalkonium Chloride LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333A Topical Pharmaceuticals Inc. BENZALKONIUM CHLORIDE 1.3 mL/mL E 20171231 15478-005_20dbda91-9eaa-4045-8413-32db362f1644 15478-005 HUMAN OTC DRUG shing-Releev Benzalkonium Chloride LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333A Topical Pharmaceuticals Inc. BENZALKONIUM CHLORIDE; ALLANTOIN; BENZYL ALCOHOL 1.3; 5; 5 mL/mL; mL/mL; mL/mL E 20171231 15579-200_42b2a7a4-9e9d-41d6-e054-00144ff8d46c 15579-200 HUMAN OTC DRUG JET ALERT Double Strength Caffine TABLET, COATED ORAL 20141126 OTC MONOGRAPH FINAL part340 Bell Pharmaceuticals, Inc CAFFEINE 200 mg/1 N 20181231 15579-201_6297ca56-119a-093b-e053-2991aa0a6c5e 15579-201 HUMAN OTC DRUG JET ALERT Regular Strength CAFFEINE TABLET, COATED ORAL 20160727 OTC MONOGRAPH FINAL part340 Bell Pharmaceuticals, Inc CAFFEINE 100 mg/1 N 20191231 15579-826_8d4a6a10-a017-45a2-b6ee-73a6e563a09c 15579-826 HUMAN OTC DRUG TRAV-L-TABS Meclizine Hydrochloride TABLET ORAL 20141201 OTC MONOGRAPH FINAL part336 Bell Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 15579-828_5b1d0797-1bdb-2729-e053-2991aa0a3054 15579-828 HUMAN OTC DRUG Jet-Asleep Double Strength Night Time Sleep Aid DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20171007 OTC MONOGRAPH FINAL part338 Bell Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 15579-837_5b1ce58c-5082-26d3-e053-2991aa0a7e6a 15579-837 HUMAN OTC DRUG Jet-Avert Motion Sickness Aid MECLIZINE HYDROCHLORIDE TABLET ORAL 20171007 OTC MONOGRAPH FINAL part336 Bell Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 15584-0101_3d84e145-928c-461b-86b6-a2994b1f6bee 15584-0101 HUMAN PRESCRIPTION DRUG Atripla efavirenz, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20060720 NDA NDA021937 Gilead Sciences, LLC EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600; 200; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 15631-0000_7d19629a-c89c-47bb-b1f9-fe4338f8b759 15631-0000 HUMAN OTC DRUG ABIES CANADENSIS ABIES CANADENSIS PELLET ORAL 20150827 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TSUGA CANADENSIS BARK 1 [hp_X]/1 N 20181231 15631-0001_ccb6ad3e-7ef1-4c54-97b6-1d7decbec3e7 15631-0001 HUMAN OTC DRUG ABIES NIGRA ABIES NIGRA PELLET ORAL 20150828 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PICEA MARIANA RESIN 1 [hp_X]/1 N 20181231 15631-0002_a37cf0c5-f9b8-4a20-a2db-e3c8a2877ae4 15631-0002 HUMAN OTC DRUG ABROTANUM ABROTANUM PELLET ORAL 20150828 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARTEMISIA ABROTANUM FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0003_565d381e-001e-40f0-83c0-6f0349eacefa 15631-0003 HUMAN OTC DRUG ABSINTHIUM ABSINTHIUM PELLET ORAL 20150828 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc WORMWOOD 3 [hp_X]/1 N 20181231 15631-0004_8fd070d1-a052-4971-a56f-f3bb6adfd3ba 15631-0004 HUMAN OTC DRUG ACETICUM ACIDUM ACETICUM ACIDUM PELLET ORAL 20150828 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ACETIC ACID 3 [hp_X]/1 N 20181231 15631-0005_1d407ada-266d-4d4c-86ac-25bb7634c860 15631-0005 HUMAN OTC DRUG ACONITUM NAPELLUS ACONITUM NAPELLUS PELLET ORAL 20150902 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ACONITUM NAPELLUS 3 [hp_X]/1 N 20181231 15631-0006_c31821f3-7418-4ba5-88b8-f1ecadc66b59 15631-0006 HUMAN OTC DRUG ACTAEA SPICATA ACTAEA SPICATA PELLET ORAL 20151101 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ACTAEA SPICATA ROOT 1 [hp_X]/1 N 20181231 15631-0007_11f0447e-5f03-452c-ab9f-8455296b4708 15631-0007 HUMAN OTC DRUG ADRENALINUM ADRENALINUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EPINEPHRINE 6 [hp_X]/1 N 20181231 15631-0008_9aa7d619-0f6d-4291-a6ee-4d6911215a75 15631-0008 HUMAN OTC DRUG AESCULUS HIPPOCASTANUM AESCULUS HIPPOCASTANUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HORSE CHESTNUT 2 [hp_X]/1 N 20181231 15631-0009_a079f9ca-56fc-4a19-b406-69694e3b0a8e 15631-0009 HUMAN OTC DRUG AETHUSA CYNAPIUM AETHUSA CYNAPIUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AETHUSA CYNAPIUM 3 [hp_X]/1 N 20181231 15631-0010_97d87788-6459-4490-ab2f-7dbe351b2c5d 15631-0010 HUMAN OTC DRUG AGARICUS MUSCARIUS AGARICUS MUSCARIUS PELLET ORAL 20150903 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AMANITA MUSCARIA FRUITING BODY 2 [hp_X]/1 N 20181231 15631-0011_e5cfd042-557e-4392-90e5-7fbd957be443 15631-0011 HUMAN OTC DRUG AGNUS CASTUS AGNUS CASTUS PELLET ORAL 20150903 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHASTE TREE 1 [hp_X]/1 N 20181231 15631-0012_10fb43ba-9516-4441-9ef6-53dae0ce413c 15631-0012 HUMAN OTC DRUG AILANTHUS GLANDULOSUS AILANTHUS GLANDULOSUS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AILANTHUS ALTISSIMA FLOWERING TWIG 1 [hp_X]/1 N 20181231 15631-0013_2362a532-6489-4779-8356-545c46df75a4 15631-0013 HUMAN OTC DRUG ALETRIS FARINOSA ALETRIS FARINOSA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALETRIS FARINOSA ROOT 1 [hp_X]/1 N 20181231 15631-0014_df7ad475-8bfa-4609-ab6b-581f538a4903 15631-0014 HUMAN OTC DRUG ALFALFA ALFALFA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALFALFA 1 [hp_X]/1 N 20181231 15631-0015_9585d5e7-717a-4b55-9fa4-c3377c4d2fc5 15631-0015 HUMAN OTC DRUG ALLIUM CEPA ALLIUM CEPA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ONION 1 [hp_X]/1 N 20181231 15631-0016_429e49f8-698c-4392-91c6-175261161e1a 15631-0016 HUMAN OTC DRUG ALLIUM SATIVUM ALLIUM SATIVUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GARLIC 1 [hp_X]/1 N 20181231 15631-0017_cc7224bc-0c1d-4401-aae3-a16c858e3fc3 15631-0017 HUMAN OTC DRUG ALNUS GLUTINOSA ALNUS GLUTINOSA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALNUS GLUTINOSA BARK 1 [hp_X]/1 N 20181231 15631-0018_04888900-b9a9-4c89-84b7-5edb40683f20 15631-0018 HUMAN OTC DRUG ALOE SOCOTRINA ALOE SOCOTRINA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALOE 1 [hp_X]/1 N 20181231 15631-0019_9d4f8704-ca66-4e59-bc81-796d51a4a476 15631-0019 HUMAN OTC DRUG ALSTONIA CONSTRICTA ALSTONIA CONSTRICTA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALSTONIA CONSTRICTA BARK 1 [hp_X]/1 N 20181231 15631-0020_b2cc735f-b11f-4b73-94cd-5216c245d6cc 15631-0020 HUMAN OTC DRUG ALSTONIA SCHOLARIS ALSTONIA SCHOLARIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALSTONIA SCHOLARIS BARK 1 [hp_X]/1 N 20181231 15631-0021_e0e64d89-d656-402e-90cb-4325c0e312b8 15631-0021 HUMAN OTC DRUG ALUMEN ALUMEN PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM ALUM 3 [hp_X]/1 N 20181231 15631-0022_05637609-b5a7-4314-bfb4-0530a3f64e8f 15631-0022 HUMAN OTC DRUG ALUMINA ALUMINA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALUMINUM OXIDE 3 [hp_X]/1 N 20181231 15631-0023_7b9f4414-7db8-4a59-89c4-4f805022b311 15631-0023 HUMAN OTC DRUG AMBRA GRISEA AMBRA GRISEA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AMBERGRIS 2 [hp_X]/1 N 20181231 15631-0024_b295c8da-ba6a-43b5-b671-5364e0627c5f 15631-0024 HUMAN OTC DRUG AMBROSIA ARTEMISIAEFOLIA AMBROSIA ARTEMISIAEFOLIA PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AMBROSIA ARTEMISIIFOLIA 1 [hp_X]/1 N 20181231 15631-0025_f5e0dd2f-e9af-40d5-9875-0a244f918f62 15631-0025 HUMAN OTC DRUG AMMONIUM BENZOICUM AMMONIUM BENZOICUM PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AMMONIUM BENZOATE 2 [hp_X]/1 N 20181231 15631-0026_0eea2d44-1d67-46cd-b4df-398dd6f56913 15631-0026 HUMAN OTC DRUG AMMONIUM BROMATUM AMMONIUM BROMATUM PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AMMONIUM BROMIDE 2 [hp_X]/1 N 20181231 15631-0027_96b366cf-acee-4839-aca5-94fa089569c0 15631-0027 HUMAN OTC DRUG AMMONIUM CARBONICUM AMMONIUM CARBONICUM PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AMMONIUM CARBONATE 3 [hp_X]/1 N 20181231 15631-0028_6eee3c37-2b00-4e3a-b510-c39485d3aa36 15631-0028 HUMAN OTC DRUG AMMONIUM IODATUM AMMONIUM IODATUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AMMONIUM IODIDE 3 [hp_X]/1 N 20181231 15631-0029_fd38fedb-b216-45d0-9ca2-9ce8d39dfd6e 15631-0029 HUMAN OTC DRUG AMMONIUM MURIATICUM AMMONIUM MURIATICUM PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AMMONIUM CHLORIDE 1 [hp_X]/1 N 20181231 15631-0030_8d429218-2be7-4a38-b890-69901a749551 15631-0030 HUMAN OTC DRUG AMMONIUM PHOSPHORICUM AMMONIUM PHOSPHORICUM PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AMMONIUM PHOSPHATE, DIBASIC 3 [hp_X]/1 N 20181231 15631-0031_d03139b2-214f-4870-80c6-7e4dec224e79 15631-0031 HUMAN OTC DRUG AMYL NITROSUM AMYL NITROSUM PELLET ORAL 20150903 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AMYL NITRITE 6 [hp_X]/1 N 20181231 15631-0032_bdb32457-b5ab-4d7c-8fe9-142db8a6e9bb 15631-0032 HUMAN OTC DRUG ANACARDIUM OCCIDENTALE ANACARDIUM OCCIDENTALE PELLET ORAL 20150903 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ANACARDIUM OCCIDENTALE FRUIT 3 [hp_X]/1 N 20181231 15631-0033_3736756e-b045-4bbf-8c93-143e4111a943 15631-0033 HUMAN OTC DRUG ANACARDIUM ORIENTALE ANACARDIUM ORIENTALE PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SEMECARPUS ANACARDIUM JUICE 3 [hp_X]/1 N 20181231 15631-0034_90eb495f-cdca-4ac5-a2ca-9d48dd9c3fda 15631-0034 HUMAN OTC DRUG ANAGALLIS ARVENSIS ANAGALLIS ARVENSIS PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ANAGALLIS ARVENSIS 1 [hp_X]/1 N 20181231 15631-0035_a72fdb21-121a-4c8e-8f4b-0e569ae46f99 15631-0035 HUMAN OTC DRUG ANTIMONIUM ARSENICICUM ANTIMONIUM ARSENICICUM PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ANTIMONY ARSENATE 6 [hp_X]/1 N 20181231 15631-0036_c80e967a-7973-45e0-9eaa-c16b9aded9a1 15631-0036 HUMAN OTC DRUG ANTIMONIUM CRUDUM ANTIMONIUM CRUDUM PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ANTIMONY TRISULFIDE 3 [hp_X]/1 N 20181231 15631-0037_0b70eac8-1eda-43b3-8dcf-5ef45e1b09ef 15631-0037 HUMAN OTC DRUG ANTIMONIUM IODATUM ANTIMONIUM IODATUM PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ANTIMONY TRIIODIDE 3 [hp_X]/1 N 20181231 15631-0038_66eab3d9-90bd-4299-aba6-c10ff0ec338b 15631-0038 HUMAN OTC DRUG ANTIMONIUM TARTARICUM ANTIMONIUM TARTARICUM PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ANTIMONY POTASSIUM TARTRATE 3 [hp_X]/1 N 20181231 15631-0039_14143cf8-3622-4196-87df-617bb7c45cfb 15631-0039 HUMAN OTC DRUG APIS MELLIFICA APIS MELLIFICA PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc APIS MELLIFERA 1 [hp_X]/1 N 20181231 15631-0040_8ecb291a-ec50-4225-ac3b-20bf96225ff3 15631-0040 HUMAN OTC DRUG APIUM GRAVEOLENS APIUM GRAVEOLENS PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CELERY SEED 1 [hp_X]/1 N 20181231 15631-0041_27a4822a-e97b-42e4-878e-6dac16764d59 15631-0041 HUMAN OTC DRUG APOCYNUM CANNABINUM APOCYNUM CANNABINUM PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc APOCYNUM CANNABINUM ROOT 3 [hp_X]/1 N 20181231 15631-0042_4ddb3d0e-46c2-42dd-9031-21df73d3c2cf 15631-0042 HUMAN OTC DRUG ARALIA RACEMOSA ARALIA RACEMOSA PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARALIA RACEMOSA ROOT 1 [hp_X]/1 N 20181231 15631-0043_8c364bde-aad8-4122-9bf4-339acaec371a 15631-0043 HUMAN OTC DRUG ARANEA DIADEMA ARANEA DIADEMA PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARANEUS DIADEMATUS 2 [hp_X]/1 N 20181231 15631-0044_ee7ccbd1-a5c9-42a2-8fb0-77fb9a60f5ca 15631-0044 HUMAN OTC DRUG ARGENTUM METALLICUM ARGENTUM METALLICUM PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SILVER 3 [hp_X]/1 N 20181231 15631-0045_4f6407fe-9970-4f6e-9f0c-63038220786f 15631-0045 HUMAN OTC DRUG ARGENTUM NITRICUM ARGENTUM NITRICUM PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SILVER NITRATE 6 [hp_X]/1 N 20181231 15631-0046_6cc53f83-dc7d-48d0-b604-f46cb7de5ee7 15631-0046 HUMAN OTC DRUG ARGENTUM OXYDATUM ARGENTUM OXYDATUM PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SILVER OXIDE 3 [hp_X]/1 N 20181231 15631-0047_565ebc4a-d9de-48db-b14f-53ca2bb59343 15631-0047 HUMAN OTC DRUG ARGENTUM PHOSPHORICUM ARGENTUM PHOSPHORICUM PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SILVER PHOSPHATE 3 [hp_X]/1 N 20181231 15631-0048_28afb8f5-409e-4126-bfa8-541aba079e23 15631-0048 HUMAN OTC DRUG ARISTOLOCHIA CLEMATITIS ARISTOLOCHIA CLEMATITIS PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARISTOLOCHIA CLEMATITIS ROOT 6 [hp_X]/1 N 20181231 15631-0049_652280a9-83e6-4118-b6bd-fa87874e970b 15631-0049 HUMAN OTC DRUG ARNICA MONTANA ARNICA MONTANA PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARNICA MONTANA 3 [hp_X]/1 N 20181231 15631-0050_5729a55e-8075-4a3e-aa17-25e17b9d76d7 15631-0050 HUMAN OTC DRUG ARSENICUM ALBUM ARSENICUM ALBUM PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARSENIC TRIOXIDE 6 [hp_X]/1 N 20181231 15631-0051_2ba03734-7d14-48a3-ad7d-2844178141a7 15631-0051 HUMAN OTC DRUG ARSENICUM BROMATUM ARSENICUM BROMATUM PELLET ORAL 20150911 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARSENIC TRIBROMIDE 6 [hp_X]/1 N 20181231 15631-0052_860602dc-0003-4f89-b8f5-ce78421184c6 15631-0052 HUMAN OTC DRUG ARSENICUM IODATUM ARSENICUM IODATUM PELLET ORAL 20150911 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARSENIC TRIIODIDE 6 [hp_X]/1 N 20181231 15631-0053_1d3732c3-8f2c-43d0-84ef-1a8cfd0fdbf7 15631-0053 HUMAN OTC DRUG ARSENICUM METALLICUM ARSENICUM METALLICUM PELLET ORAL 20150911 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARSENIC 8 [hp_X]/1 N 20181231 15631-0054_0bfb911e-9f28-44f0-8432-7e0b2a553702 15631-0054 HUMAN OTC DRUG ARSENICUM SULPHURATUM FLAVUM ARSENICUM SULPHURATUM FLAVUM PELLET ORAL 20150911 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARSENIC TRISULFIDE 6 [hp_X]/1 N 20181231 15631-0055_75d34b5b-ffa0-429d-9c07-619e48ba77ab 15631-0055 HUMAN OTC DRUG ARSENICUM SULPHURATUM RUBRUM ARSENICUM SULPHURATUM RUBRUM PELLET ORAL 20150911 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TETRAARSENIC TETRASULFIDE 6 [hp_X]/1 N 20181231 15631-0056_8a4c12fc-8eab-4b53-b897-8466b1fd7549 15631-0056 HUMAN OTC DRUG ARTEMISIA VULGARIS ARTEMISIA VULGARIS PELLET ORAL 20150911 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARTEMISIA VULGARIS ROOT 1 [hp_X]/1 N 20181231 15631-0057_11b80b4b-b55a-496f-a13a-49333d36b83e 15631-0057 HUMAN OTC DRUG ARUM TRIPHYLLUM ARUM TRIPHYLLUM PELLET ORAL 20150911 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARISAEMA TRIPHYLLUM ROOT 1 [hp_X]/1 N 20181231 15631-0058_972d651e-bd57-4674-bda7-6a3c7ec44769 15631-0058 HUMAN OTC DRUG ASAFOETIDA ASAFOETIDA PELLET ORAL 20150911 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ASAFETIDA 1 [hp_X]/1 N 20181231 15631-0059_bd54e62b-aa15-426b-886c-7bd2fdf77f94 15631-0059 HUMAN OTC DRUG ASARUM EUROPAEUM ASARUM EUROPAEUM PELLET ORAL 20150911 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ASARUM EUROPAEUM 1 [hp_X]/1 N 20181231 15631-0061_e08d0e91-4541-45b3-8760-b0f84975dc36 15631-0061 HUMAN OTC DRUG ASPARAGUS OFFICINALIS ASPARAGUS OFFICINALIS PELLET ORAL 20150911 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ASPARAGUS 2 [hp_X]/1 N 20181231 15631-0062_d48ccab4-0da0-43c6-9d9c-c2aa7b01d6b7 15631-0062 HUMAN OTC DRUG ASTERIAS RUBENS ASTERIAS RUBENS PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ASTERIAS RUBENS 2 [hp_X]/1 N 20181231 15631-0063_700e0ef0-2dc5-4e12-94a3-516259265e8b 15631-0063 HUMAN OTC DRUG AURUM BROMATUM AURUM BROMATUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GOLD TRIBROMIDE 4 [hp_X]/1 N 20181231 15631-0064_9045d1f8-d790-4ab8-aba8-0f907422f4ea 15631-0064 HUMAN OTC DRUG AURUM IODATUM AURUM IODATUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GOLD MONOIODIDE 6 [hp_X]/1 N 20181231 15631-0065_6e2dfcf3-2967-454e-bed6-6abe25deb3ab 15631-0065 HUMAN OTC DRUG AURUM METALLICUM AURUM METALLICUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GOLD 3 [hp_X]/1 N 20181231 15631-0066_908de8b0-f3f8-4983-b7d7-0412abe0a49f 15631-0066 HUMAN OTC DRUG AURUM MURIATICUM AURUM MURIATICUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GOLD TRICHLORIDE 3 [hp_X]/1 N 20181231 15631-0067_5e446de1-fe9a-48b9-a5ad-d731229577ce 15631-0067 HUMAN OTC DRUG AURUM MURIATICUM NATRONATUM AURUM MURIATICUM NATRONATUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM TETRACHLOROAURATE 3 [hp_X]/1 N 20181231 15631-0069_9ec17a38-5e61-4ec7-a5d7-9498ffa9c7ee 15631-0069 HUMAN OTC DRUG AVENA SATIVA AVENA SATIVA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AVENA SATIVA FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0070_8384360e-b34e-4269-af51-610519fe766f 15631-0070 HUMAN OTC DRUG BADIAGA BADIAGA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SPONGILLA LACUSTRIS 2 [hp_X]/1 N 20181231 15631-0071_d8511270-9cb3-4d2d-a690-a37509a8c9a9 15631-0071 HUMAN OTC DRUG BALSAMUM PERUVIANUM BALSAMUM PERUVIANUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BALSAM PERU 1 [hp_X]/1 N 20181231 15631-0072_c91401fb-84af-4e61-bdaf-c939261d7cdd 15631-0072 HUMAN OTC DRUG BAPTISIA TINCTORIA BAPTISIA TINCTORIA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BAPTISIA TINCTORIA ROOT 1 [hp_X]/1 N 20181231 15631-0073_e151da22-1219-4656-ae68-f5aac221020a 15631-0073 HUMAN OTC DRUG BARYTA CARBONICA BARYTA CARBONICA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BARIUM CARBONATE 6 [hp_X]/1 N 20181231 15631-0074_4aa397af-4b55-41fa-a73a-627e2c869921 15631-0074 HUMAN OTC DRUG BARYTA IODATA BARYTA IODATA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BARIUM IODIDE 6 [hp_X]/1 N 20181231 15631-0075_92179b7b-6acc-4969-9533-0e1e785c4376 15631-0075 HUMAN OTC DRUG BARYTA MURIATICA BARYTA MURIATICA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BARIUM CHLORIDE DIHYDRATE 6 [hp_X]/1 N 20181231 15631-0076_4c3e545c-8e33-4e2a-839d-49b46fbb8d23 15631-0076 HUMAN OTC DRUG BELLADONNA BELLADONNA PELLET ORAL 20150903 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ATROPA BELLADONNA 3 [hp_X]/1 N 20181231 15631-0077_008b7aaf-da22-4736-95df-5738396f4ceb 15631-0077 HUMAN OTC DRUG BELLIS PERENNIS BELLIS PERENNIS PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BELLIS PERENNIS 1 [hp_X]/1 N 20181231 15631-0078_79975c51-bdba-4935-a4de-1ff447cf90ee 15631-0078 HUMAN OTC DRUG BENZOICUM ACIDUM BENZOICUM ACIDUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BENZOIC ACID 1 [hp_X]/1 N 20181231 15631-0079_fd366071-3004-49d2-a971-c75bd2f49df8 15631-0079 HUMAN OTC DRUG BERBERIS AQUIFOLIUM BERBERIS AQUIFOLIUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MAHONIA AQUIFOLIUM ROOT BARK 1 [hp_X]/1 N 20181231 15631-0080_c595d4cc-1a08-4e2c-a5fc-312de8a5be15 15631-0080 HUMAN OTC DRUG BERBERIS VULGARIS BERBERIS VULGARIS PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BERBERIS VULGARIS ROOT BARK 1 [hp_X]/1 N 20181231 15631-0081_dca0f9a9-c86e-4bcd-9b6c-ede1ade08b97 15631-0081 HUMAN OTC DRUG BISMUTHUM METALLICUM BISMUTHUM METALLICUM PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BISMUTH 6 [hp_X]/1 N 20181231 15631-0082_30f810ea-f075-4875-8430-f6692f571cfb 15631-0082 HUMAN OTC DRUG BLATTA AMERICANA BLATTA AMERICANA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PERIPLANETA AMERICANA 2 [hp_X]/1 N 20181231 15631-0083_86018e58-6600-4690-a613-b8ad438ecc64 15631-0083 HUMAN OTC DRUG BLATTA ORIENTALIS BLATTA ORIENTALIS PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BLATTA ORIENTALIS 2 [hp_X]/1 N 20181231 15631-0084_470993b5-1151-4839-9243-b652519bb9ca 15631-0084 HUMAN OTC DRUG BORAX BORAX PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM BORATE 1 [hp_X]/1 N 20181231 15631-0085_5097db2d-cdc0-451e-b9e5-652e2c218dd5 15631-0085 HUMAN OTC DRUG BORICUM ACIDUM BORICUM ACIDUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BORIC ACID 3 [hp_X]/1 N 20181231 15631-0086_76568862-4a88-4fdb-8991-368a5ff6b2dc 15631-0086 HUMAN OTC DRUG BROMIUM BROMIUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BROMINE 6 [hp_X]/1 N 20181231 15631-0087_0162c28c-60d5-44ba-9deb-472def251da8 15631-0087 HUMAN OTC DRUG BRYONIA ALBA BRYONIA ALBA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BRYONIA ALBA ROOT 3 [hp_X]/1 N 20181231 15631-0088_131844ca-7642-4c34-a8f6-d39f1f67c82d 15631-0088 HUMAN OTC DRUG CACTUS GRANDIFLORUS CACTUS GRANDIFLORUS PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SELENICEREUS GRANDIFLORUS STEM 3 [hp_X]/1 N 20181231 15631-0089_aba83e75-4ae5-4855-b1fb-436360be1ba3 15631-0089 HUMAN OTC DRUG CADMIUM SULPHURICUM CADMIUM SULPHURICUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CADMIUM SULFATE 6 [hp_X]/1 N 20181231 15631-0090_092b8d34-0044-4b6f-8c7f-37defe4aba70 15631-0090 HUMAN OTC DRUG CALADIUM SEGUINUM CALADIUM SEGUINUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DIEFFENBACHIA SEGUINE 3 [hp_X]/1 N 20181231 15631-0091_f6c812ca-a605-43ff-9cad-47cc0f12e10c 15631-0091 HUMAN OTC DRUG CALCAREA ACETICA CALCAREA ACETICA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM ACETATE 1 [hp_X]/1 N 20181231 15631-0092_17752c82-7774-454e-b8e9-03ce76faa43b 15631-0092 HUMAN OTC DRUG CALCAREA ARSENICICA CALCAREA ARSENICICA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM ARSENATE 6 [hp_X]/1 N 20181231 15631-0093_63b6598c-0e9e-402f-9fc7-cb868c7112b2 15631-0093 HUMAN OTC DRUG CALCAREA CARBONICA CALCAREA CARBONICA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc OYSTER SHELL CALCIUM CARBONATE, CRUDE 1 [hp_X]/1 N 20181231 15631-0094_2364e2ba-d64b-4216-9851-985aeece137c 15631-0094 HUMAN OTC DRUG CALCAREA CAUSTICA CALCAREA CAUSTICA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM HYDROXIDE 6 [hp_X]/1 N 20181231 15631-0095_a90a9633-37b6-4be0-b385-4065621cb016 15631-0095 HUMAN OTC DRUG CALCAREA FLUORICA CALCAREA FLUORICA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM FLUORIDE 3 [hp_X]/1 N 20181231 15631-0096_8e1a692f-973b-40f7-866e-19ac4579d931 15631-0096 HUMAN OTC DRUG CALCAREA IODATA CALCAREA IODATA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM IODIDE 3 [hp_X]/1 N 20181231 15631-0097_05e19c50-3ab2-45ec-b1a1-6200fd49e69d 15631-0097 HUMAN OTC DRUG CALCAREA MURIATICA CALCAREA MURIATICA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM CHLORIDE 3 [hp_X]/1 N 20181231 15631-0098_d4e49f92-8da3-45c6-9dad-4099a1b40cc9 15631-0098 HUMAN OTC DRUG CALCAREA OXALICA CALCAREA OXALICA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM OXALATE MONOHYDRATE 3 [hp_X]/1 N 20181231 15631-0099_5919e2dd-e2fb-4204-b4e4-2b03889e0c30 15631-0099 HUMAN OTC DRUG CALCAREA PHOSPHORICA CALCAREA PHOSPHORICA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE 1 [hp_X]/1 N 20181231 15631-0100_ed3276ee-947e-4601-b96e-beb77d5dde44 15631-0100 HUMAN OTC DRUG CALCAREA SULPHURICA CALCAREA SULPHURICA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM SULFATE ANHYDROUS 1 [hp_X]/1 N 20181231 15631-0101_7b98e6d7-8780-4124-9b77-f1507def01ff 15631-0101 HUMAN OTC DRUG CALENDULA OFFICINALIS CALENDULA OFFICINALIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0102_0d6c809c-c8a7-4096-81a9-a47d2096e267 15631-0102 HUMAN OTC DRUG CALOTROPIS GIGANTEA CALOTROPIS GIGANTEA PELLET ORAL 20151006 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALOTROPIS GIGANTEA ROOT 1 [hp_X]/1 N 20181231 15631-0103_1809ed3a-b684-4c7e-9621-b1867660fb79 15631-0103 HUMAN OTC DRUG CAMPHORA CAMPHORA PELLET ORAL 20151006 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CAMPHOR (NATURAL) 1 [hp_X]/1 N 20181231 15631-0104_b68df27d-b8f9-4ae1-ac92-24b5f2766026 15631-0104 HUMAN OTC DRUG CANTHARIDINUM CANTHARIDINUM PELLET ORAL 20151006 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CANTHARIDIN 8 [hp_X]/1 N 20181231 15631-0105_7180d045-050e-4f0e-ac51-1aaa5eff57c0 15631-0105 HUMAN OTC DRUG CANTHARIS CANTHARIS PELLET ORAL 20151006 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LYTTA VESICATORIA 3 [hp_X]/1 N 20181231 15631-0106_644286cd-7684-478a-8088-592a849a9fb6 15631-0106 HUMAN OTC DRUG CAPSICUM ANNUUM CAPSICUM ANNUUM PELLET ORAL 20151006 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CAPSICUM 3 [hp_X]/1 N 20181231 15631-0107_5baee4e4-95e1-4bec-a12e-a20ad1e9f62c 15631-0107 HUMAN OTC DRUG CARBO ANIMALIS CARBO ANIMALIS PELLET ORAL 20151006 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CARBO ANIMALIS 1 [hp_X]/1 N 20181231 15631-0108_c87f6c05-9050-4cb8-8d55-000bd8aa14a9 15631-0108 HUMAN OTC DRUG CARBO VEGETABILIS CARBO VEGETABILIS PELLET ORAL 20151006 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ACTIVATED CHARCOAL 1 [hp_X]/1 N 20181231 15631-0109_c27bb05c-e18a-40c5-a36c-93c8e6835bd5 15631-0109 HUMAN OTC DRUG CARBOLICUM ACIDUM CARBOLICUM ACIDUM PELLET ORAL 20151006 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PHENOL 6 [hp_X]/1 N 20181231 15631-0110_fab0ed17-e047-452c-bbe0-b4b1fe09ff70 15631-0110 HUMAN OTC DRUG CARBONEUM CARBONEUM PELLET ORAL 20151006 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc D&C BLACK NO. 2 3 [hp_X]/1 N 20181231 15631-0111_0b20b9f1-3905-4052-82b7-7e145797efea 15631-0111 HUMAN OTC DRUG CARBONEUM SULPHURATUM CARBONEUM SULPHURATUM PELLET ORAL 20151006 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CARBON DISULFIDE 6 [hp_X]/1 N 20181231 15631-0112_7f9107d5-fef1-4528-ab48-a2d9f7bba67b 15631-0112 HUMAN OTC DRUG CARDUUS MARIANUS CARDUUS MARIANUS PELLET ORAL 20151006 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MILK THISTLE 1 [hp_X]/1 N 20181231 15631-0113_11c6bd68-40c2-41dd-bb63-8d79f4331897 15631-0113 HUMAN OTC DRUG CASCARILLA CASCARILLA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CROTON ELUTERIA BARK 1 [hp_X]/1 N 20181231 15631-0114_fdf46ede-39b1-49d4-8330-cf1e0f5ca544 15631-0114 HUMAN OTC DRUG CASTANEA VESCA CASTANEA VESCA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CASTANEA SATIVA LEAF 1 [hp_X]/1 N 20181231 15631-0115_2185b575-e1a1-4d7a-9418-3799e35bbfb2 15631-0115 HUMAN OTC DRUG CASTOR EQUI CASTOR EQUI PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EQUUS CABALLUS LEG CALLOUS 3 [hp_X]/1 N 20181231 15631-0116_14b2937f-7e38-4782-915b-7f1b7afdcc47 15631-0116 HUMAN OTC DRUG CASTOREUM (CASTOR CANADENSIS) CASTOREUM (CASTOR CANADENSIS) PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CASTOR CANADENSIS SCENT GLAND SECRETION 2 [hp_X]/1 N 20181231 15631-0117_be932310-4943-4d08-afe0-19abff56c8f1 15631-0117 HUMAN OTC DRUG CAULOPHYLLUM THALICTROIDES CAULOPHYLLUM THALICTROIDES PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CAULOPHYLLUM THALICTROIDES ROOT 3 [hp_X]/1 N 20181231 15631-0118_0a04317f-30e5-4557-b76c-def11140784f 15631-0118 HUMAN OTC DRUG CAUSTICUM CAUSTICUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CAUSTICUM 2 [hp_X]/1 N 20181231 15631-0119_ab999a90-6ad4-4ec8-9cac-6df83cf780cd 15631-0119 HUMAN OTC DRUG CEANOTHUS AMERICANUS CEANOTHUS AMERICANUS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CEANOTHUS AMERICANUS LEAF 1 [hp_X]/1 N 20181231 15631-0120_9184761e-8f38-40e8-9b67-d4b40050813e 15631-0120 HUMAN OTC DRUG CEDRON CEDRON PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SIMABA CEDRON SEED 1 [hp_X]/1 N 20181231 15631-0121_36b3020e-d3cb-4a90-ba99-dc28bcce171d 15631-0121 HUMAN OTC DRUG CENCHRIS CONTORTRIX CENCHRIS CONTORTRIX PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AGKISTRODON CONTORTRIX VENOM 8 [hp_X]/1 N 20181231 15631-0122_11ec4de7-d63c-46b8-964e-c867d289349b 15631-0122 HUMAN OTC DRUG CEPHALANTHUS OCCIDENTALIS CEPHALANTHUS OCCIDENTALIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CEPHALANTHUS OCCIDENTALIS BARK 1 [hp_X]/1 N 20181231 15631-0123_5e24dbbd-2656-4f63-b28a-ba90db591112 15631-0123 HUMAN OTC DRUG CHAMOMILLA CHAMOMILLA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MATRICARIA RECUTITA 1 [hp_X]/1 N 20181231 15631-0124_323e2c5a-7ecc-48a7-aec5-76daf144954c 15631-0124 HUMAN OTC DRUG CHELIDONIUM MAJUS CHELIDONIUM MAJUS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHELIDONIUM MAJUS 1 [hp_X]/1 N 20181231 15631-0125_a491ef1a-ef1a-42b0-af0e-5c5d8683a4e8 15631-0125 HUMAN OTC DRUG CHENOPODIUM ANTHELMINTICUM CHENOPODIUM ANTHELMINTICUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DYSPHANIA AMBROSIOIDES 1 [hp_X]/1 N 20181231 15631-0126_e4fe6765-64ad-414c-9edd-c2d76247b0b0 15631-0126 HUMAN OTC DRUG CHIMAPHILA UMBELLATA CHIMAPHILA UMBELLATA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHIMAPHILA UMBELLATA 1 [hp_X]/1 N 20181231 15631-0127_a66f6781-e245-491c-9b6e-3a5d3ad3f71b 15631-0127 HUMAN OTC DRUG CHININUM ARSENICICUM CHININUM ARSENICICUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc QUININE ARSENATE 6 [hp_X]/1 N 20181231 15631-0128_4cf70437-612d-42d7-a1f5-1ef2e796af56 15631-0128 HUMAN OTC DRUG CHININUM SALICYLICUM CHININUM SALICYLICUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc QUININE SALICYLATE 3 [hp_X]/1 N 20181231 15631-0129_4bb575f8-a81f-4184-9fb3-0550937f5b40 15631-0129 HUMAN OTC DRUG CHININUM SULPHURICUM CHININUM SULPHURICUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc QUININE SULFATE 3 [hp_X]/1 N 20181231 15631-0130_065459ea-76b3-40bb-a05f-e3c4bb2874e8 15631-0130 HUMAN OTC DRUG CHIONANTHUS VIRGINICA CHIONANTHUS VIRGINICA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHIONANTHUS VIRGINICUS BARK 1 [hp_X]/1 N 20181231 15631-0131_a00cc61a-25a5-456b-8581-be4371f83165 15631-0131 HUMAN OTC DRUG CHLORINUM CHLORINUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHLORINE 6 [hp_X]/1 N 20181231 15631-0132_f7fb91dd-e02f-44f8-8c3b-b6b148661f68 15631-0132 HUMAN OTC DRUG CHOLESTERINUM CHOLESTERINUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHOLESTEROL 3 [hp_X]/1 N 20181231 15631-0133_1cd92516-eefe-4054-bb48-3dad0bd8452d 15631-0133 HUMAN OTC DRUG CHROMICUM ACIDUM(CHROMIUM) CHROMICUM ACIDUM(CHROMIUM) PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHROMIUM TRIOXIDE 6 [hp_X]/1 N 20181231 15631-0134_831175bd-507f-498e-b2de-3640bd21198e 15631-0134 HUMAN OTC DRUG CICUTA VIROSA CICUTA VIROSA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CICUTA VIROSA ROOT 3 [hp_X]/1 N 20181231 15631-0135_395dd609-3b1a-4c0d-a3f9-22e96930c639 15631-0135 HUMAN OTC DRUG CIMEX LECTULARIUS CIMEX LECTULARIUS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CIMEX LECTULARIUS 2 [hp_X]/1 N 20181231 15631-0136_ac990d43-ab65-4c83-b288-06ff1ce2e3d4 15631-0136 HUMAN OTC DRUG CIMICIFUGA RACEMOSA CIMICIFUGA RACEMOSA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BLACK COHOSH 1 [hp_X]/1 N 20181231 15631-0137_7f394e2d-1f31-405c-9d78-e76b078bd7c6 15631-0137 HUMAN OTC DRUG CINA CINA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARTEMISIA CINA PRE-FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0138_b5e3de11-f381-4db0-a028-0a6f2dbf3661 15631-0138 HUMAN OTC DRUG CINCHONA OFFICINALIS CINCHONA OFFICINALIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CINCHONA OFFICINALIS BARK 2 [hp_X]/1 N 20181231 15631-0139_20ae10ad-86ef-47e4-b6f3-3b67cf1a6b84 15631-0139 HUMAN OTC DRUG CINERARIA MARITIMA CINERARIA MARITIMA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc JACOBAEA MARITIMA 1 [hp_X]/1 N 20181231 15631-0140_9c8dc483-2704-41dc-9ea5-3a1a75869bc5 15631-0140 HUMAN OTC DRUG CINNAMOMUM CINNAMOMUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CINNAMON 1 [hp_X]/1 N 20181231 15631-0141_ff2add94-fac3-40da-ae62-7e49319c8c70 15631-0141 HUMAN OTC DRUG CISTUS CANADENSIS CISTUS CANADENSIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HELIANTHEMUM CANADENSE 1 [hp_X]/1 N 20181231 15631-0142_7def161c-bcac-4bec-8e3e-251450d74b2d 15631-0142 HUMAN OTC DRUG CITRUS DECUMANA CITRUS DECUMANA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PUMMELO 1 [hp_X]/1 N 20181231 15631-0143_cb25c36f-2835-40ec-9dfb-e0cd4efe67cb 15631-0143 HUMAN OTC DRUG CLEMATIS ERECTA CLEMATIS ERECTA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CLEMATIS RECTA FLOWERING TOP 3 [hp_X]/1 N 20181231 15631-0144_0514e002-a08c-4b46-8cb9-b54659020b68 15631-0144 HUMAN OTC DRUG COBALTUM METALLICUM COBALTUM METALLICUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COBALT 6 [hp_X]/1 N 20181231 15631-0145_d7331b5c-1103-476f-ac86-e69d2900a9c9 15631-0145 HUMAN OTC DRUG COCCULUS INDICUS COCCULUS INDICUS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ANAMIRTA COCCULUS SEED 3 [hp_X]/1 N 20181231 15631-0146_b681d381-a819-4dd8-a389-23593c79664d 15631-0146 HUMAN OTC DRUG COCCUS CACTI COCCUS CACTI PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PROTORTONIA CACTI 1 [hp_X]/1 N 20181231 15631-0147_a790d084-3d91-4c26-8334-dad6b000749e 15631-0147 HUMAN OTC DRUG COFFEA CRUDA COFFEA CRUDA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARABICA COFFEE BEAN 1 [hp_X]/1 N 20181231 15631-0148_ef60477c-3639-41c4-9e12-23a251cfd412 15631-0148 HUMAN OTC DRUG COFFEA TOSTA COFFEA TOSTA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COFFEA ARABICA SEED, ROASTED 1 [hp_X]/1 N 20181231 15631-0149_2d9d75b9-80f7-4744-a02a-9bbcdf9fa434 15631-0149 HUMAN OTC DRUG COLCHICINUM COLCHICINUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COLCHICINE 6 [hp_X]/1 N 20181231 15631-0150_58a19698-59fa-4e81-a01b-b1a6613f5f58 15631-0150 HUMAN OTC DRUG COLCHICUM AUTUMNALE COLCHICUM AUTUMNALE PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COLCHICUM AUTUMNALE BULB 3 [hp_X]/1 N 20181231 15631-0151_d9a51878-88ac-481d-9b6b-0ecde8200576 15631-0151 HUMAN OTC DRUG COLLINSONIA CANADENSIS COLLINSONIA CANADENSIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COLLINSONIA CANADENSIS ROOT 1 [hp_X]/1 N 20181231 15631-0152_ee4c9de6-9553-4797-9486-e0e13a6893b6 15631-0152 HUMAN OTC DRUG COLOCYNTHIS COLOCYNTHIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CITRULLUS COLOCYNTHIS FRUIT PULP 3 [hp_X]/1 N 20181231 15631-0153_5ae169c5-83b5-443c-8b87-bad7ef36f77f 15631-0153 HUMAN OTC DRUG CONDURANGO CONDURANGO PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MARSDENIA CONDURANGO BARK 1 [hp_X]/1 N 20181231 15631-0154_36cc7390-c056-4f2f-9c9a-3c214bf8fe4a 15631-0154 HUMAN OTC DRUG CONIUM MACULATUM CONIUM MACULATUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CONIUM MACULATUM FLOWERING TOP 3 [hp_X]/1 N 20181231 15631-0155_fbc3f853-e55b-4284-b5c3-2067a1eba715 15631-0155 HUMAN OTC DRUG CONVALLARIA MAJALIS CONVALLARIA MAJALIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CONVALLARIA MAJALIS 3 [hp_X]/1 N 20181231 15631-0156_8e28e5d5-74b4-4d48-a907-e0addd15f9de 15631-0156 HUMAN OTC DRUG COPAIVA OFFICINALIS COPAIVA OFFICINALIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COPAIFERA OFFICINALIS RESIN 1 [hp_X]/1 N 20181231 15631-0157_5cea9493-f4d7-471d-b6a4-63030956f298 15631-0157 HUMAN OTC DRUG CORALLIUM RUBRUM CORALLIUM RUBRUM PELLET ORAL 20151006 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CORALLIUM RUBRUM EXOSKELETON 1 [hp_X]/1 N 20181231 15631-0158_09099196-bc37-421a-b3b4-a6ee5ff92613 15631-0158 HUMAN OTC DRUG CROCUS SATIVUS CROCUS SATIVUS PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SAFFRON 3 [hp_X]/1 N 20181231 15631-0159_07bae010-0fb6-44fe-9bcb-604f5c256945 15631-0159 HUMAN OTC DRUG CROTALUS HORRIDUS CROTALUS HORRIDUS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CROTALUS HORRIDUS HORRIDUS VENOM 8 [hp_X]/1 N 20181231 15631-0160_6ee50e7a-59fd-4b34-a003-0ad14ebfcf67 15631-0160 HUMAN OTC DRUG CROTON TIGLIUM CROTON TIGLIUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CROTON TIGLIUM SEED 3 [hp_X]/1 N 20181231 15631-0161_e419e81d-f066-4391-aa0d-19f5de96f6f0 15631-0161 HUMAN OTC DRUG CUBEBA OFFICINALIS CUBEBA OFFICINALIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PIPER CUBEBA FRUIT 1 [hp_X]/1 N 20181231 15631-0162_9b772ec6-f0b7-469d-a525-0037dacd1a11 15631-0162 HUMAN OTC DRUG CUPRUM ACETICUM CUPRUM ACETICUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CUPRIC ACETATE 3 [hp_X]/1 N 20181231 15631-0163_564430df-d3cc-4b3f-94ba-bf4815f750ba 15631-0163 HUMAN OTC DRUG CUPRUM METALLICUM CUPRUM METALLICUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COPPER 3 [hp_X]/1 N 20181231 15631-0164_5c7fbef2-530b-4f90-8286-0d4ad7186d74 15631-0164 HUMAN OTC DRUG CUCURBITA CITRULLUS CUCURBITA CITRULLUS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc WATERMELON SEED 1 [hp_X]/1 N 20181231 15631-0165_d66c0790-aea1-4689-b2c2-5cb68bf4b133 15631-0165 HUMAN OTC DRUG CYCLAMEN EUROPAEUM CYCLAMEN EUROPAEUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CYCLAMEN PURPURASCENS TUBER 3 [hp_X]/1 N 20181231 15631-0166_99f62abd-77c7-4603-9540-bc9bf392e1ca 15631-0166 HUMAN OTC DRUG DAPHNE INDICA DAPHNE INDICA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DAPHNE ODORA BARK 1 [hp_X]/1 N 20181231 15631-0167_b0f94eaa-38ce-43b4-8db8-f6f878f1abaf 15631-0167 HUMAN OTC DRUG DIGITALIS PURPUREA DIGITALIS PURPUREA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DIGITALIS 6 [hp_X]/1 N 20181231 15631-0168_69166991-9ec7-4644-b9fd-c25705efa165 15631-0168 HUMAN OTC DRUG DIOSCOREA VILLOSA DIOSCOREA VILLOSA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DIOSCOREA VILLOSA TUBER 1 [hp_X]/1 N 20181231 15631-0169_1469f2b1-bc20-427f-a5b7-7169243681bd 15631-0169 HUMAN OTC DRUG DIOSCOREINUM DIOSCOREINUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DIOSCORINE 6 [hp_X]/1 N 20181231 15631-0170_ad9bd005-94f1-4f45-9cf3-c72079c3b112 15631-0170 HUMAN OTC DRUG DOLICHOS PRURIENS DOLICHOS PRURIENS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MUCUNA PRURIENS FRUIT TRICHOME 1 [hp_X]/1 N 20181231 15631-0171_7ffbc5b9-1cf5-4716-9bdd-891f257ab9f5 15631-0171 HUMAN OTC DRUG DROSERA ROTUNDIFOLIA DROSERA ROTUNDIFOLIA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DROSERA ROTUNDIFOLIA 1 [hp_X]/1 N 20181231 15631-0172_6906e570-700e-4cca-9371-96c6f8b883e2 15631-0172 HUMAN OTC DRUG DULCAMARA DULCAMARA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SOLANUM DULCAMARA TOP 2 [hp_X]/1 N 20181231 15631-0173_1e54508b-e542-4a63-96ba-2f573cb69a70 15631-0173 HUMAN OTC DRUG ECHINACEA ANGUSTIFOLIA ECHINACEA ANGUSTIFOLIA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ECHINACEA ANGUSTIFOLIA 1 [hp_X]/1 N 20181231 15631-0174_33c19aa8-3fbd-4672-82e2-ffa0e9f66649 15631-0174 HUMAN OTC DRUG ECHINACEA PURPUREA ECHINACEA PURPUREA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ECHINACEA PURPUREA 1 [hp_X]/1 N 20181231 15631-0175_1ab5125e-467a-4179-8aac-633be81813a2 15631-0175 HUMAN OTC DRUG ELAPS CORALLINUS ELAPS CORALLINUS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MICRURUS CORALLINUS VENOM 8 [hp_X]/1 N 20181231 15631-0176_ac1f420e-9bab-4004-a115-56e826064468 15631-0176 HUMAN OTC DRUG EPIGAEA REPENS EPIGAEA REPENS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EPIGAEA REPENS 1 [hp_X]/1 N 20181231 15631-0177_d3172ef8-2bf7-4e7c-90c7-e7a2a9a06a15 15631-0177 HUMAN OTC DRUG EPIPHEGUS VIRGINIANA EPIPHEGUS VIRGINIANA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EPIFAGUS VIRGINIANA 1 [hp_X]/1 N 20181231 15631-0178_b1984d13-342d-47d5-91b8-9caf2347cfda 15631-0178 HUMAN OTC DRUG EQUISETUM ARVENSE EQUISETUM ARVENSE PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EQUISETUM ARVENSE TOP 1 [hp_X]/1 N 20181231 15631-0179_caa5178e-7fce-4dad-bd84-e82cb9085e57 15631-0179 HUMAN OTC DRUG EQUISETUM HYEMALE EQUISETUM HYEMALE PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EQUISETUM HYEMALE 3 [hp_X]/1 N 20181231 15631-0180_58453b1a-0310-4efc-8323-8608bcfe5bcd 15631-0180 HUMAN OTC DRUG ERIGERON CANADENSIS ERIGERON CANADENSIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CONYZA CANADENSIS 1 [hp_X]/1 N 20181231 15631-0181_a7b27e02-81ea-4093-b624-0de900a1ae32 15631-0181 HUMAN OTC DRUG EUCALYPTUS GLOBULUS EUCALYPTUS GLOBULUS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EUCALYPTUS GLOBULUS LEAF 1 [hp_X]/1 N 20181231 15631-0182_a0e49ab2-9adc-4f27-8e14-09b2d0fef1ce 15631-0182 HUMAN OTC DRUG EUPATORIUM PERFOLIATUM EUPATORIUM PERFOLIATUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EUPATORIUM PERFOLIATUM FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0183_fe7a8ba7-0963-40c5-b17b-3810cbf23b15 15631-0183 HUMAN OTC DRUG EUPATORIUM PURPUREUM EUPATORIUM PURPUREUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EUTROCHIUM PURPUREUM ROOT 1 [hp_X]/1 N 20181231 15631-0184_78816cd8-9564-4ee6-b7e1-1db249271e2a 15631-0184 HUMAN OTC DRUG EUPHRASIA OFFICINALIS EUPHRASIA OFFICINALIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EUPHRASIA STRICTA 1 [hp_X]/1 N 20181231 15631-0185_d1444909-4940-4e5e-bb03-43563c29ae1b 15631-0185 HUMAN OTC DRUG FAGOPYRUM ESCULENTUM FAGOPYRUM ESCULENTUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FAGOPYRUM ESCULENTUM 1 [hp_X]/1 N 20181231 15631-0186_576ac655-f747-4201-926c-914e4b2bbd16 15631-0186 HUMAN OTC DRUG FEL TAURI FEL TAURI PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BOS TAURUS BILE 1 [hp_X]/1 N 20181231 15631-0187_9806e0ac-d0d1-4d2f-8fd5-7633701855d8 15631-0187 HUMAN OTC DRUG FERRUM ACETICUM FERRUM ACETICUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERRIC ACETATE, BASIC 2 [hp_X]/1 N 20181231 15631-0188_ac570715-8665-4707-857d-f83468790f2f 15631-0188 HUMAN OTC DRUG FERRUM ARSENICICUM FERRUM ARSENICICUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROUS ARSENATE 6 [hp_X]/1 N 20181231 15631-0189_833c1030-6404-4905-8667-4b82716ac9b5 15631-0189 HUMAN OTC DRUG FERRUM BROMATUM FERRUM BROMATUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROUS BROMIDE 3 [hp_X]/1 N 20181231 15631-0190_6a578d92-1a03-4d50-b5d5-e3f33a119b57 15631-0190 HUMAN OTC DRUG FERRUM METALLICUM FERRUM METALLICUM PELLET ORAL 20151025 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc IRON 1 [hp_X]/1 N 20181231 15631-0191_35423751-167e-4761-9c6c-44ff30f98ccc 15631-0191 HUMAN OTC DRUG FERRUM MURIATICUM FERRUM MURIATICUM PELLET ORAL 20151025 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERRIC CHLORIDE HEXAHYDRATE 2 [hp_X]/1 N 20181231 15631-0192_e93151e0-560a-400d-8842-74fd60db8c03 15631-0192 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERRUM PHOSPHORICUM PELLET ORAL 20151025 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROSOFERRIC PHOSPHATE 1 [hp_X]/1 N 20181231 15631-0193_f0f0b073-cac5-433e-8a56-c5bbb82f0256 15631-0193 HUMAN OTC DRUG FERRUM PICRICUM FERRUM PICRICUM PELLET ORAL 20151025 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERRIC PICRATE 6 [hp_X]/1 N 20181231 15631-0194_ff91d223-a7be-41ef-9b4e-0575d7b4e610 15631-0194 HUMAN OTC DRUG FERRUM SULPHURICUM FERRUM SULPHURICUM PELLET ORAL 20151025 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROUS SULFATE 1 [hp_X]/1 N 20181231 15631-0195_e875331b-c436-4298-b025-c4578c5887cc 15631-0195 HUMAN OTC DRUG FICUS RELIGIOSA FICUS RELIGIOSA PELLET ORAL 20151025 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FICUS RELIGIOSA LEAFY TWIG 1 [hp_X]/1 N 20181231 15631-0196_ed0b198a-3523-47b5-9ad1-ccf94bf9e64b 15631-0196 HUMAN OTC DRUG FILIX MAS FILIX MAS PELLET ORAL 20151025 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DRYOPTERIS FILIX-MAS ROOT 1 [hp_X]/1 N 20181231 15631-0197_206131ac-4216-454c-8b0f-629ee75f2eb4 15631-0197 HUMAN OTC DRUG FORMICA RUFA FORMICA RUFA PELLET ORAL 20151025 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FORMICA RUFA 1 [hp_X]/1 N 20181231 15631-0198_00582ce0-43e4-4bfb-8664-ca8cb9ec3b52 15631-0198 HUMAN OTC DRUG FRAXINUS AMERICANA FRAXINUS AMERICANA PELLET ORAL 20151025 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FRAXINUS AMERICANA BARK 1 [hp_X]/1 N 20181231 15631-0199_94a0fb24-193e-4ce6-8c5b-f5c2f07d9524 15631-0199 HUMAN OTC DRUG FUCUS VESICULOSUS FUCUS VESICULOSUS PELLET ORAL 20151025 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FUCUS VESICULOSUS 1 [hp_X]/1 N 20181231 15631-0200_736cf117-3830-4767-a63f-5e46e3e8446b 15631-0200 HUMAN OTC DRUG GALANTHUS NIVALIS GALANTHUS NIVALIS PELLET ORAL 20151025 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GALANTHUS NIVALIS 1 [hp_X]/1 N 20181231 15631-0201_6fc6f347-6455-485c-92f4-50ec810e79d5 15631-0201 HUMAN OTC DRUG GALLICUM ACIDUM GALLICUM ACIDUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GALLIC ACID MONOHYDRATE 2 [hp_X]/1 N 20181231 15631-0202_9bcb6859-40be-4500-8174-2f980430f002 15631-0202 HUMAN OTC DRUG GAMBOGIA GAMBOGIA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GAMBOGE 1 [hp_X]/1 N 20181231 15631-0203_7ee08ffb-ff39-49a2-ac2b-4fa24c2746ef 15631-0203 HUMAN OTC DRUG GAULTHERIA PROCUMBENS GAULTHERIA PROCUMBENS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GAULTHERIA PROCUMBENS TOP 1 [hp_X]/1 N 20181231 15631-0205_dd05ba01-baf2-466d-8ec7-6dff19ebcc16 15631-0205 HUMAN OTC DRUG GENTIANA QUINQUEFLORA GENTIANA QUINQUEFLORA PELLET ORAL 20151027 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GENTIANELLA QUINQUEFOLIA 1 [hp_X]/1 N 20181231 15631-0206_7cafc25f-6b1e-47d3-8f56-c805b4dc42a2 15631-0206 HUMAN OTC DRUG GERANIUM MACULATUM GERANIUM MACULATUM PELLET ORAL 20151027 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GERANIUM MACULATUM ROOT 1 [hp_X]/1 N 20181231 15631-0207_6b80baed-ec3e-4351-a528-17d7220dd3a4 15631-0207 HUMAN OTC DRUG GLONOINUM GLONOINUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc NITROGLYCERIN 6 [hp_X]/1 N 20181231 15631-0208_c04106a4-c7e4-47f7-aede-e12701afbe92 15631-0208 HUMAN OTC DRUG GNAPHALIUM POLYCEPHALUM GNAPHALIUM POLYCEPHALUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PSEUDOGNAPHALIUM OBTUSIFOLIUM 1 [hp_X]/1 N 20181231 15631-0209_b0bbd0a8-fbf0-483c-9f04-5a7cc78e7aa4 15631-0209 HUMAN OTC DRUG GOSSYPIUM HERBACEUM GOSSYPIUM HERBACEUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GOSSYPIUM HERBACEUM ROOT BARK 1 [hp_X]/1 N 20181231 15631-0210_f62a10c5-e1d7-424b-9625-0cf5a66822c0 15631-0210 HUMAN OTC DRUG GRAPHITES GRAPHITES PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GRAPHITE 1 [hp_X]/1 N 20181231 15631-0211_00302efb-4622-4a50-a437-cc8cfe0b81aa 15631-0211 HUMAN OTC DRUG GRATIOLA OFFICINALIS GRATIOLA OFFICINALIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GRATIOLA OFFICINALIS 1 [hp_X]/1 N 20181231 15631-0213_1772d409-8b28-42f0-b654-83f105cadfc4 15631-0213 HUMAN OTC DRUG GUACO GUACO PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MIKANIA PARVIFLORA LEAF 1 [hp_X]/1 N 20181231 15631-0214_3cdcd82f-c079-4b71-83bb-4b13439fab43 15631-0214 HUMAN OTC DRUG GUAIACUM GUAIACUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GUAIACUM OFFICINALE RESIN 1 [hp_X]/1 N 20181231 15631-0216_f5b9daa1-05b4-429c-9e5b-e897e038ff54 15631-0216 HUMAN OTC DRUG HAMAMELIS VIRGINIANA HAMAMELIS VIRGINIANA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]/1 N 20181231 15631-0217_9ae2f232-556c-4e07-aea1-08357099293c 15631-0217 HUMAN OTC DRUG HEDEOMA PULEGIOIDES HEDEOMA PULEGIOIDES PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HEDEOMA PULEGIOIDES 3 [hp_X]/1 N 20181231 15631-0218_0edf30a1-99f0-446a-90bd-b594b0e93b01 15631-0218 HUMAN OTC DRUG HEKLA LAVA HEKLA LAVA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HEKLA LAVA 1 [hp_X]/1 N 20181231 15631-0219_5a725146-3675-4d5e-9f32-45813a885f46 15631-0219 HUMAN OTC DRUG HELIANTHUS ANNUUS HELIANTHUS ANNUUS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HELIANTHUS ANNUUS FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0220_e12055b5-2a44-4646-89dc-3a7c87f04117 15631-0220 HUMAN OTC DRUG HELLEBORUS FOETIDUS HELLEBORUS FOETIDUS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HELLEBORUS FOETIDUS ROOT 3 [hp_X]/1 N 20181231 15631-0221_5c19e90d-75c4-45c5-bef1-a4a3d8c748bf 15631-0221 HUMAN OTC DRUG HELLEBORUS NIGER HELLEBORUS NIGER PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HELLEBORUS NIGER ROOT 3 [hp_X]/1 N 20181231 15631-0222_e7d9463b-37aa-4162-b5d1-47317f20f690 15631-0222 HUMAN OTC DRUG HELODERMA HORRIDUM VENOM HELODERMA HORRIDUM VENOM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HELODERMA HORRIDUM VENOM 8 [hp_X]/1 N 20181231 15631-0223_9c3ab44b-4b84-4b6e-bcab-0fbd17cf145a 15631-0223 HUMAN OTC DRUG HELONIAS DIOICA HELONIAS DIOICA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHAMAELIRIUM LUTEUM ROOT 1 [hp_X]/1 N 20181231 15631-0224_506bc219-ef95-472b-bdb6-fa982d861787 15631-0224 HUMAN OTC DRUG HEPAR SULPHURIS CALCAREUM HEPAR SULPHURIS CALCAREUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM SULFIDE 1 [hp_X]/1 N 20181231 15631-0225_bfe79861-9a0a-4eba-bc80-96bfa8bfaca1 15631-0225 HUMAN OTC DRUG HYDRANGEA ARBORESCENS HYDRANGEA ARBORESCENS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HYDRANGEA ARBORESCENS ROOT 1 [hp_X]/1 N 20181231 15631-0226_928cb737-45fa-45c6-83b1-7ff05395623d 15631-0226 HUMAN OTC DRUG HYDRASTIS CANADENSIS HYDRASTIS CANADENSIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GOLDENSEAL 1 [hp_X]/1 N 20181231 15631-0227_a2851216-7144-4110-a4ae-66dc8e965b26 15631-0227 HUMAN OTC DRUG HYDROCOTYLE ASIATICA HYDROCOTYLE ASIATICA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CENTELLA ASIATICA 1 [hp_X]/1 N 20181231 15631-0228_22dcf6b6-a65a-4643-910c-890ef5f6c3e6 15631-0228 HUMAN OTC DRUG HYOSCYAMUS NIGER HYOSCYAMUS NIGER PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HYOSCYAMUS NIGER 3 [hp_X]/1 N 20181231 15631-0229_7039c12f-c10f-4965-ab8b-a73bf7cdff14 15631-0229 HUMAN OTC DRUG HYPERICUM PERFORATUM HYPERICUM PERFORATUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HYPERICUM PERFORATUM 3 [hp_X]/1 N 20181231 15631-0230_8bc1ae68-07fa-48a6-aedc-09184bea9118 15631-0230 HUMAN OTC DRUG IBERIS AMARA IBERIS AMARA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc IBERIS AMARA SEED 1 [hp_X]/1 N 20181231 15631-0231_0f1a6e9e-7b9f-4805-b300-1541037342f2 15631-0231 HUMAN OTC DRUG ICHTHYOLUM ICHTHYOLUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ICHTHAMMOL 3 [hp_X]/1 N 20181231 15631-0232_78291f57-44cd-42a6-8b88-dd7fa932544b 15631-0232 HUMAN OTC DRUG IGNATIA AMARA IGNATIA AMARA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc STRYCHNOS IGNATII SEED 3 [hp_X]/1 N 20181231 15631-0233_025b4ba8-a5ca-432d-b91e-26ceafc08538 15631-0233 HUMAN OTC DRUG INDIGO INDIGO PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc D&C BLUE NO. 6 3 [hp_X]/1 N 20181231 15631-0234_e896bfa6-b733-470a-b133-c45c844c2342 15631-0234 HUMAN OTC DRUG INDIUM METALLICUM INDIUM METALLICUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc INDIUM 3 [hp_X]/1 N 20181231 15631-0235_7dd0611a-11a6-497f-84cd-9793c58f7132 15631-0235 HUMAN OTC DRUG INFLUENZINUM INFLUENZINUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc INFLUENZA A VIRUS 8 [hp_X]/1 N 20181231 15631-0236_08031370-d152-409e-91ac-623b06fee32f 15631-0236 HUMAN OTC DRUG IODIUM IODIUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc IODINE 3 [hp_X]/1 N 20181231 15631-0237_028b0ea3-7867-488d-8a6e-d479aa39f527 15631-0237 HUMAN OTC DRUG IPECACUANHA IPECACUANHA PELLET ORAL 20150902 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc IPECAC 3 [hp_X]/1 N 20181231 15631-0238_d0c19ff5-fa0c-452c-9e3f-5a3f9df8064c 15631-0238 HUMAN OTC DRUG IRIDIUM METALLICUM IRIDIUM METALLICUM PELLET ORAL 20150902 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc IRIDIUM 3 [hp_X]/1 N 20181231 15631-0239_4010a564-4526-4082-9efb-dc334b67e2de 15631-0239 HUMAN OTC DRUG IRIS TENAX IRIS TENAX PELLET ORAL 20150902 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc IRIS TENAX 1 [hp_X]/1 N 20181231 15631-0240_cf4faebb-d3f5-4b1a-8e9b-6e4a442e9d8a 15631-0240 HUMAN OTC DRUG IRIS VERSICOLOR IIRIS VERSICOLOR PELLET ORAL 20150902 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc IRIS VERSICOLOR ROOT 1 [hp_X]/1 N 20181231 15631-0241_ce7b2a4d-85d3-4817-822e-57d071607150 15631-0241 HUMAN OTC DRUG JACARANDA CAROBA JACARANDA CAROBA PELLET ORAL 20150902 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc JACARANDA CAROBA FLOWER 1 [hp_X]/1 N 20181231 15631-0242_3cd0756b-afde-46f6-9819-a4a05617229f 15631-0242 HUMAN OTC DRUG JALAPA JJALAPA PELLET ORAL 20150902 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc IPOMOEA PURGA ROOT 1 [hp_X]/1 N 20181231 15631-0243_785422be-e147-419d-9e02-c40dbe44cb6e 15631-0243 HUMAN OTC DRUG JUGLANS REGIA JUGLANS REGIA PELLET ORAL 20150903 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ENGLISH WALNUT 1 [hp_X]/1 N 20181231 15631-0244_9d5536cb-ac55-4db6-92d5-c322ddb3877a 15631-0244 HUMAN OTC DRUG JUNIPERUS COMMUNIS JUNIPERUS COMMUNIS PELLET ORAL 20150903 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc JUNIPER BERRY 1 [hp_X]/1 N 20181231 15631-0245_5bac62aa-b1ca-4243-8962-a108dfb46327 15631-0245 HUMAN OTC DRUG JUNIPERUS VIRGINIANA JUNIPERUS VIRGINIANA PELLET ORAL 20150903 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc JUNIPERUS VIRGINIANA TWIG 1 [hp_X]/1 N 20181231 15631-0246_6eb3145d-fc8b-47f0-abb8-6d1006e07a5f 15631-0246 HUMAN OTC DRUG KALI ARSENICOSUM KALI ARSENICOSUM PELLET ORAL 20150903 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM ARSENITE ANHYDROUS 6 [hp_X]/1 N 20181231 15631-0247_94e3960f-13df-4a66-b49d-71548839a0d7 15631-0247 HUMAN OTC DRUG KALI BICHROMICUM KALI BICHROMICUM PELLET ORAL 20150903 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM DICHROMATE 3 [hp_X]/1 N 20181231 15631-0248_8cd4a8c5-41a9-4c4d-a02b-008080536393 15631-0248 HUMAN OTC DRUG KALI BROMATUM KALI BROMATUM PELLET ORAL 20150903 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM BROMIDE 1 [hp_X]/1 N 20181231 15631-0249_2bce0f82-57bb-4c7f-a235-9f90c9caabfe 15631-0249 HUMAN OTC DRUG KALI CARBONICUM KALI CARBONICUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM CARBONATE 2 [hp_X]/1 N 20181231 15631-0250_5be6ded4-f8cb-4895-8c95-46f8a21a28ab 15631-0250 HUMAN OTC DRUG KALI IODATUM KALI IODATUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM IODIDE 1 [hp_X]/1 N 20181231 15631-0251_954003b2-879d-4819-971c-9c84123cad6f 15631-0251 HUMAN OTC DRUG KALI MURIATICUM KALI MURIATICUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM CHLORIDE 1 [hp_X]/1 N 20181231 15631-0252_92964f5f-332f-4e98-b709-3a3e8a1867ab 15631-0252 HUMAN OTC DRUG KALI NITRICUM KALI NITRICUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM NITRATE 6 [hp_X]/1 N 20181231 15631-0253_7d9ceace-7781-40cf-b686-7b64c7ee97ab 15631-0253 HUMAN OTC DRUG KALI PHOSPHORICUM KALI PHOSPHORICUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM PHOSPHATE, DIBASIC 1 [hp_X]/1 N 20181231 15631-0254_e50e1ed6-81aa-4a3a-83cb-145bd4b1f371 15631-0254 HUMAN OTC DRUG KALI SULPHURICUM KALI SULPHURICUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM SULFATE 1 [hp_X]/1 N 20181231 15631-0255_9b3035da-170a-4a37-8b32-b09e23a0881b 15631-0255 HUMAN OTC DRUG KALMIA LATIFOLIA KALMIA LATIFOLIA PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc KALMIA LATIFOLIA LEAF 3 [hp_X]/1 N 20181231 15631-0256_126d7672-3154-408e-b4e9-860b0ab7ad08 15631-0256 HUMAN OTC DRUG KREOSOTUM KREOSOTUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc WOOD CREOSOTE 3 [hp_X]/1 N 20181231 15631-0257_2a81668d-93e4-4cc0-b52e-bdf92d187276 15631-0257 HUMAN OTC DRUG LAC CANINUM LAC CANINUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CANIS LUPUS FAMILIARIS MILK 3 [hp_X]/1 N 20181231 15631-0258_4c82494f-dea3-4a78-a1ee-ddb981425ff9 15631-0258 HUMAN OTC DRUG LAC DEFLORATUM LAC DEFLORATUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SKIM MILK 3 [hp_X]/1 N 20181231 15631-0259_d4228e75-1e23-4af7-8e7a-17e7ca379341 15631-0259 HUMAN OTC DRUG LAC FELINUM LAC FELINUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FELIS CATUS MILK 3 [hp_X]/1 N 20181231 15631-0260_ae48c5bb-39c1-4955-ba3b-723340e67cac 15631-0260 HUMAN OTC DRUG LAC VACCINUM LAC VACCINUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COW MILK 3 [hp_X]/1 N 20181231 15631-0261_4d3d79ea-b865-4a96-9fcb-2c50caebf59e 15631-0261 HUMAN OTC DRUG LACHESIS MUTUS LACHESIS MUTUS PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LACHESIS MUTA VENOM 8 [hp_X]/1 N 20181231 15631-0262_fcd35bb4-676a-4ecc-ba4d-366cee20c5e8 15631-0262 HUMAN OTC DRUG LACHNANTHES TINCTORIA LACHNANTHES TINCTORIA PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LACHNANTHES CAROLINIANA 1 [hp_X]/1 N 20181231 15631-0263_adb3ef44-8ff5-49c4-af15-24b869af0774 15631-0263 HUMAN OTC DRUG LACTUCA VIROSA LACTUCA VIROSA PELLET ORAL 20150906 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LACTUCA VIROSA 3 [hp_X]/1 N 20181231 15631-0264_d97a1acb-df80-46f6-bce5-bfe724fd2556 15631-0264 HUMAN OTC DRUG LACTICUM ACIDUM LACTICUM ACIDUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LACTIC ACID, DL- 2 [hp_X]/1 N 20181231 15631-0265_60846b38-f413-4dbe-a161-7878f9d138a7 15631-0265 HUMAN OTC DRUG LAMIUM ALBUM LAMIUM ALBUM PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LAMIUM ALBUM 1 [hp_X]/1 N 20181231 15631-0266_952d4ac3-98e4-4010-8435-ac1bdb8a1d19 15631-0266 HUMAN OTC DRUG LAPIS ALBUS LAPIS ALBUS PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM HEXAFLUOROSILICATE 6 [hp_X]/1 N 20181231 15631-0267_8e61d79b-ba15-4cc0-a988-be2001003483 15631-0267 HUMAN OTC DRUG LAPPA MAJOR LAPPA MAJOR PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARCTIUM LAPPA ROOT 1 [hp_X]/1 N 20181231 15631-0268_74fd3d85-9f65-40b1-93d1-2a909c659927 15631-0268 HUMAN OTC DRUG LATHYRUS SATIVUS LATHYRUS SATIVUS PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LATHYRUS SATIVAS SEED 1 [hp_X]/1 N 20181231 15631-0269_fe47adcf-5fd2-4164-88e4-e5606cfce537 15631-0269 HUMAN OTC DRUG LATRODECTUS MACTANS LATRODECTUS MACTANS PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LATRODECTUS MACTANS 8 [hp_X]/1 N 20181231 15631-0270_9935f9a0-fed2-424c-b86b-160353b3c0de 15631-0270 HUMAN OTC DRUG LAUROCERASUS LAUROCERASUS PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PRUNUS LAUROCERASUS LEAF 3 [hp_X]/1 N 20181231 15631-0271_82053a68-4af2-4664-8dd5-504067c53f39 15631-0271 HUMAN OTC DRUG LECITHIN LECITHIN PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EGG PHOSPHOLIPIDS 2 [hp_X]/1 N 20181231 15631-0272_317d828d-f20a-4e49-808f-defb1de1c918 15631-0272 HUMAN OTC DRUG LEDUM PALUSTRE LEDUM PALUSTRE PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LEDUM PALUSTRE TWIG 1 [hp_X]/1 N 20181231 15631-0273_72c70a84-b89c-420d-b794-e4d6e78d04f2 15631-0273 HUMAN OTC DRUG LEMNA MINOR LEMNA MINOR PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LEMNA MINOR 1 [hp_X]/1 N 20181231 15631-0274_762b4773-c588-4bab-8d5a-1fe240ebd0b1 15631-0274 HUMAN OTC DRUG LEPTANDRA VIRGINICA LEPTANDRA VIRGINICA PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VERONICASTRUM VIRGINICUM ROOT 1 [hp_X]/1 N 20181231 15631-0275_5db5acfc-1f74-4174-8157-746377691247 15631-0275 HUMAN OTC DRUG LILIUM TIGRINUM LILIUM TIGRINUM PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LILIUM LANCIFOLIUM WHOLE FLOWERING 1 [hp_X]/1 N 20181231 15631-0276_edaf6c80-b953-4d95-a925-64e6ac9fd884 15631-0276 HUMAN OTC DRUG LITHIUM CARBONICUM LITHIUM CARBONICUM PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LITHIUM CARBONATE 3 [hp_X]/1 N 20181231 15631-0277_8b50efa9-36f5-436e-8c71-514fb808c675 15631-0277 HUMAN OTC DRUG LOBELIA INFLATA LOBELIA INFLATA PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LOBELIA INFLATA 3 [hp_X]/1 N 20181231 15631-0278_3777508c-f752-44ad-a9f6-c71baf036dc2 15631-0278 HUMAN OTC DRUG LYCOPODIUM CLAVATUM LYCOPODIUM CLAVATUM PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LYCOPODIUM CLAVATUM SPORE 1 [hp_X]/1 N 20181231 15631-0279_a88c51b5-d234-4058-b997-dad41bf6b974 15631-0279 HUMAN OTC DRUG LYCOPUS VIRGINICUS LYCOPUS VIRGINICUS PELLET ORAL 20150907 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LYCOPUS VIRGINICUS 1 [hp_X]/1 N 20181231 15631-0280_5457e6dc-e487-4ae5-aef3-5f4237605b7f 15631-0280 HUMAN OTC DRUG MAGNESIA CARBONICA MAGNESIA CARBONICA PELLET ORAL 20150909 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MAGNESIUM CARBONATE 1 [hp_X]/1 N 20181231 15631-0281_63f0c164-1c0e-4144-8248-52ec8b834c29 15631-0281 HUMAN OTC DRUG MAGNESIA MURIATICA MAGNESIA MURIATICA PELLET ORAL 20150909 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MAGNESIUM CHLORIDE 1 [hp_X]/1 N 20181231 15631-0282_b985d55c-b60c-4517-81b5-4f4f0698a6ff 15631-0282 HUMAN OTC DRUG MAGNESIA PHOSPHORICA MAGNESIA PHOSPHORICA PELLET ORAL 20150909 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 1 [hp_X]/1 N 20181231 15631-0283_31c043f5-1d17-49b0-8342-4f585418a48b 15631-0283 HUMAN OTC DRUG MAGNESIA SULPHURICA MAGNESIA SULPHURICA PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MAGNESIUM SULFATE HEPTAHYDRATE 1 [hp_X]/1 N 20181231 15631-0284_70033231-3d9c-43df-b122-27bec2fcaf63 15631-0284 HUMAN OTC DRUG MAGNOLIA GRANDIFLORA MAGNOLIA GRANDIFLORA PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MAGNOLIA GRANDIFLORA FLOWER 1 [hp_X]/1 N 20181231 15631-0285_7f612633-96b8-46d3-87b7-03b8a56e0e0c 15631-0285 HUMAN OTC DRUG MANGANUM ACETICUM MANGANUM ACETICUM PELLET ORAL 20150909 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MANGANESE ACETATE TETRAHYDRATE 3 [hp_X]/1 N 20181231 15631-0286_a28f60cc-0368-4332-a934-ed921363a908 15631-0286 HUMAN OTC DRUG MANGANUM MURIATICUM MANGANUM MURIATICUM PELLET ORAL 20150909 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MANGANESE CHLORIDE 3 [hp_X]/1 N 20181231 15631-0288_1f974da6-2b45-4a75-992e-f858eab445a5 15631-0288 HUMAN OTC DRUG MELILOTUS OFFICINALIS MELILOTUS OFFICINALIS PELLET ORAL 20150909 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MELILOTUS OFFICINALIS TOP 3 [hp_X]/1 N 20181231 15631-0289_e40c70d0-ef9b-403f-aeed-63d95af2ff79 15631-0289 HUMAN OTC DRUG MENYANTHES TRIFOLIATA MENYANTHES TRIFOLIATA PELLET ORAL 20150909 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MENYANTHES TRIFOLIATA 1 [hp_X]/1 N 20181231 15631-0290_7ed75b9b-ad5d-413c-8743-d4bcfba6c517 15631-0290 HUMAN OTC DRUG MEPHITIS MEPHITICA MEPHITIS MEPHITICA PELLET ORAL 20150909 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MEPHITIS MEPHITIS ANAL GLAND FLUID 6 [hp_X]/1 N 20181231 15631-0291_adaae0e6-ba90-43b1-a44e-1a75d68f7446 15631-0291 HUMAN OTC DRUG MERCURIUS CORROSIVUS MERCURIUS CORROSIVUS PELLET ORAL 20150909 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MERCURIC CHLORIDE 6 [hp_X]/1 N 20181231 15631-0292_e744ed1d-b1f0-46e2-aec2-585345fa7e37 15631-0292 HUMAN OTC DRUG MERCURIUS DULCIS MERCURIUS DULCIS PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALOMEL 6 [hp_X]/1 N 20181231 15631-0293_87b0e980-2280-4d2e-a2ed-6f707d385eee 15631-0293 HUMAN OTC DRUG MERCURIUS IODATUS FLAVUS MERCURIUS IODATUS FLAVUS PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MERCUROUS IODIDE 6 [hp_X]/1 N 20181231 15631-0294_9e956a8b-2554-4aa1-921c-af0888b66e7e 15631-0294 HUMAN OTC DRUG MERCURIUS IODATUS RUBER MERCURIUS IODATUS RUBER PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MERCURIC IODIDE 6 [hp_X]/1 N 20181231 15631-0295_31911872-4739-42ac-abf4-b723f6c9bd89 15631-0295 HUMAN OTC DRUG MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MERCURIUS SOLUBILIS 6 [hp_X]/1 N 20181231 15631-0296_ae1a0ebd-64c6-456e-b0be-9d51a3acd72b 15631-0296 HUMAN OTC DRUG MEZEREUM MEZEREUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DAPHNE MEZEREUM BARK 1 [hp_X]/1 N 20181231 15631-0297_0785ca18-5d0f-4fa1-98e4-110b902dc0b7 15631-0297 HUMAN OTC DRUG MILLEFOLIUM MILLEFOLIUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ACHILLEA MILLEFOLIUM 1 [hp_X]/1 N 20181231 15631-0298_7ccafc2c-9214-4a8e-92ff-156f00ae63b9 15631-0298 HUMAN OTC DRUG MOSCHUS MOSCHUS PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MOSCHUS MOSCHIFERUS MUSK SAC RESIN 6 [hp_X]/1 N 20181231 15631-0299_e998422f-6ab9-405f-b5e4-fbb0422aa0f1 15631-0299 HUMAN OTC DRUG MUREX PURPUREA MUREX PURPUREA PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE 2 [hp_X]/1 N 20181231 15631-0300_3f67d7e0-13f3-41e2-b2b1-ba0779aeff0d 15631-0300 HUMAN OTC DRUG MURIATICUM ACIDUM MURIATICUM ACIDUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HYDROCHLORIC ACID 6 [hp_X]/1 N 20181231 15631-0301_854a1557-76fd-4ed2-8dda-46497e24a5bd 15631-0301 HUMAN OTC DRUG MYGALE MYGALE PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AVICULARIA AVICULARIA 8 [hp_X]/1 N 20181231 15631-0302_ee0ef62b-feb0-4454-a1c9-13b8e2e0d6b2 15631-0302 HUMAN OTC DRUG MYRICA CERIFERA MYRICA CERIFERA PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MORELLA CERIFERA ROOT BARK 1 [hp_X]/1 N 20181231 15631-0303_ecdc3932-e490-4894-8206-18bf2929137a 15631-0303 HUMAN OTC DRUG MYRISTICA SEBIFER MYRISTICA SEBIFER PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VIROLA SEBIFERA RESIN 1 [hp_X]/1 N 20181231 15631-0304_a7cd3aa9-e357-4545-a50e-f804f15ea4d6 15631-0304 HUMAN OTC DRUG NAJA TRIPUDIANS NAJA TRIPUDIANS PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc NAJA NAJA VENOM 8 [hp_X]/1 N 20181231 15631-0305_81df9d9b-e982-4db8-a4bb-339b813651db 15631-0305 HUMAN OTC DRUG NAPHTHALINUM NAPHTHALINUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc NAPHTHALENE 3 [hp_X]/1 N 20181231 15631-0306_2f1e9785-6535-401b-ab6a-f1ad719e1a69 15631-0306 HUMAN OTC DRUG NARCISSUS PSEUDO-NARCISSUS NARCISSUS PSEUDO-NARCISSUS PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc NARCISSUS PSEUDONARCISSUS 3 [hp_X]/1 N 20181231 15631-0307_e5ac0ea5-6077-49a8-98b3-2f5ac30a8ef2 15631-0307 HUMAN OTC DRUG NATRUM ARSENICICUM NATRUM ARSENICICUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE 6 [hp_X]/1 N 20181231 15631-0308_fbf7512f-0841-453e-82b5-1e15e69719ee 15631-0308 HUMAN OTC DRUG NATRUM CARBONICUM NATRUM CARBONICUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM CARBONATE 1 [hp_X]/1 N 20181231 15631-0309_9e9c1310-bce6-4b19-afc4-f4d93c286d1f 15631-0309 HUMAN OTC DRUG NATRUM MURIATICUM NATRUM MURIATICUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM CHLORIDE 1 [hp_X]/1 N 20181231 15631-0310_103cad63-6536-411a-a767-661e9bcd16c1 15631-0310 HUMAN OTC DRUG NATRUM PHOSPHORICUM NATRUM PHOSPHORICUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 1 [hp_X]/1 N 20181231 15631-0311_e85f7669-1a86-4172-8f60-318875b340a3 15631-0311 HUMAN OTC DRUG NATRUM SALICYLICUM NATRUM SALICYLICUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM SALICYLATE 2 [hp_X]/1 N 20181231 15631-0312_73ff360d-c607-45c2-bc0c-03a9609773aa 15631-0312 HUMAN OTC DRUG NATRUM SULPHURICUM NATRUM SULPHURICUM PELLET ORAL 20150911 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM SULFATE 1 [hp_X]/1 N 20181231 15631-0313_13826b8e-0b85-4b28-8b48-e4ce212617fc 15631-0313 HUMAN OTC DRUG NICCOLUM METALLICUM NICCOLUM METALLICUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc NICKEL 3 [hp_X]/1 N 20181231 15631-0314_b52dff71-9a0a-4d1e-b752-933e5a9ef012 15631-0314 HUMAN OTC DRUG NICCOLUM SULPHURICUM NICCOLUM SULPHURICUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc NICKEL SULFATE HEXAHYDRATE 3 [hp_X]/1 N 20181231 15631-0315_89a4cc13-f5fe-4170-94bd-b73274f2dd78 15631-0315 HUMAN OTC DRUG NITRICUM ACIDUM NITRICUM ACIDUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc NITRIC ACID 6 [hp_X]/1 N 20181231 15631-0316_35364c8e-49e4-4526-8098-71a09a18cfec 15631-0316 HUMAN OTC DRUG NUX MOSCHATA NUX MOSCHATA PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc NUTMEG 1 [hp_X]/1 N 20181231 15631-0317_04b2e85e-dabe-4af2-912c-bb763b7fee9e 15631-0317 HUMAN OTC DRUG NUX VOMICA NUX VOMICA PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc STRYCHNOS NUX-VOMICA SEED 3 [hp_X]/1 N 20181231 15631-0318_a1fdfcc7-ead2-4440-a810-438f3291644d 15631-0318 HUMAN OTC DRUG OENANTHE CROCATA OENANTHE CROCATA PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc OENANTHE CROCATA ROOT 3 [hp_X]/1 N 20181231 15631-0319_bb265b3b-75b3-4681-8551-e1cdadceadd6 15631-0319 HUMAN OTC DRUG OLEANDER OLEANDER PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc NERIUM OLEANDER LEAF 3 [hp_X]/1 N 20181231 15631-0320_9fdb28b6-7ad8-42cd-9c93-429a89662862 15631-0320 HUMAN OTC DRUG ONOSMODIUM VIRGINIANUM ONOSMODIUM VIRGINIANUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ONOSMODIUM VIRGINIANUM WHOLE 1 [hp_X]/1 N 20181231 15631-0321_75736e7d-7e3d-49f1-b88f-4ded7440779d 15631-0321 HUMAN OTC DRUG OOPHORINUM OOPHORINUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SUS SCROFA OVARY 6 [hp_X]/1 N 20181231 15631-0322_1e743a99-4a34-4f7f-ab4a-256b7517bd71 15631-0322 HUMAN OTC DRUG OPUNTIA VULGARIS OPUNTIA VULGARIS PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc OPUNTIA FICUS-INDICA 1 [hp_X]/1 N 20181231 15631-0323_115a7720-04a5-447c-9d19-cee6d3568d22 15631-0323 HUMAN OTC DRUG OSMIUM METALLICUM OSMIUM METALLICUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc OSMIUM 6 [hp_X]/1 N 20181231 15631-0324_28909331-5605-4d91-adf2-e3811897f567 15631-0324 HUMAN OTC DRUG OVA TOSTA OVA TOSTA PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EGG SHELL, COOKED 1 [hp_X]/1 N 20181231 15631-0325_94ec0897-38d9-4296-a7f6-51a6cedfe312 15631-0325 HUMAN OTC DRUG OXALICUM ACIDUM OXALICUM ACIDUM PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc OXALIC ACID DIHYDRATE 6 [hp_X]/1 N 20181231 15631-0326_11c05266-39b5-4584-a40b-2590505dc971 15631-0326 HUMAN OTC DRUG PAEONIA OFFICINALIS PAEONIA OFFICINALIS PELLET ORAL 20150910 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PAEONIA OFFICINALIS ROOT 1 [hp_X]/1 N 20181231 15631-0327_0e7f2c00-1eef-4e5f-a4dd-a7caa60f3b24 15631-0327 HUMAN OTC DRUG PALLADIUM METALLICUM PALLADIUM METALLICUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PALLADIUM 6 [hp_X]/1 N 20181231 15631-0328_aa9bfc4b-7297-4a90-8c17-975ccbeb85ff 15631-0328 HUMAN OTC DRUG PARAFFINUM PARAFFINUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PARAFFIN 1 [hp_X]/1 N 20181231 15631-0329_631c6447-a9da-417e-83d0-6fefd0a2db6c 15631-0329 HUMAN OTC DRUG PAREIRA BRAVA PAREIRA BRAVA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHONDRODENDRON TOMENTOSUM ROOT 1 [hp_X]/1 N 20181231 15631-0330_47128fa6-2557-41b8-8968-37db79df84f1 15631-0330 HUMAN OTC DRUG PARIS QUADRIFOLIA PARIS QUADRIFOLIA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PARIS QUADRIFOLIA 3 [hp_X]/1 N 20181231 15631-0331_c1d9d3a8-d814-44f1-9710-f3995b75f211 15631-0331 HUMAN OTC DRUG PASSIFLORA INCARNATA PASSIFLORA INCARNATA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PASSIFLORA INCARNATA FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0332_d876fe37-ee99-4b16-b0eb-4fe8405396ff 15631-0332 HUMAN OTC DRUG PETROLEUM PETROLEUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc KEROSENE 1 [hp_X]/1 N 20181231 15631-0333_c878db7d-66dd-4889-9af7-657d5472006d 15631-0333 HUMAN OTC DRUG PETROSELINUM SATIVUM PETROSELINUM SATIVUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PETROSELINUM CRISPUM 1 [hp_X]/1 N 20181231 15631-0334_40ee7f19-ef7e-4a65-9942-a0a143ec3bf1 15631-0334 HUMAN OTC DRUG PHELLANDRIUM AQUATICUM PHELLANDRIUM AQUATICUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc OENANTHE AQUATICA FRUIT 1 [hp_X]/1 N 20181231 15631-0335_b1d976a5-39c2-4c0a-9fc6-b284e55edae8 15631-0335 HUMAN OTC DRUG PHOSPHORICUM ACIDUM PHOSPHORICUM ACIDUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PHOSPHORIC ACID 3 [hp_X]/1 N 20181231 15631-0336_f9436a72-8c87-42e3-ad35-5bc7acbfced2 15631-0336 HUMAN OTC DRUG PHOSPHORUS PHOSPHORUS PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PHOSPHORUS 4 [hp_X]/1 N 20181231 15631-0337_ef168a28-a1fb-4711-9e5e-669766c8e3a4 15631-0337 HUMAN OTC DRUG PHYSALIS ALKEKENGI PHYSALIS ALKEKENGI PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PHYSALIS ALKEKENGI FRUIT 1 [hp_X]/1 N 20181231 15631-0338_eb55ed81-7dce-4a36-bf04-75da12f04e7e 15631-0338 HUMAN OTC DRUG PHYSOSTIGMA VENENOSUM PHYSOSTIGMA VENENOSUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PHYSOSTIGMA VENENOSUM SEED 4 [hp_X]/1 N 20181231 15631-0339_c7f32cea-03ed-4ddb-bb69-a64eac8ef318 15631-0339 HUMAN OTC DRUG PHYTOLACCA DECANDRA PHYTOLACCA DECANDRA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PHYTOLACCA AMERICANA ROOT 2 [hp_X]/1 N 20181231 15631-0340_cf97c457-cbc3-470e-8e13-111676d68478 15631-0340 HUMAN OTC DRUG PICRICUM ACIDUM PICRICUM ACIDUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PICRIC ACID 6 [hp_X]/1 N 20181231 15631-0341_0beb5718-065c-4ba6-b00a-ea551a57bff4 15631-0341 HUMAN OTC DRUG PILOCARPUS PILOCARPUS PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PILOCARPUS JABORANDI LEAF 3 [hp_X]/1 N 20181231 15631-0342_9c955471-079e-46d1-bf92-3b468dd17456 15631-0342 HUMAN OTC DRUG PINUS LAMBERTIANA PINUS LAMBERTIANA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PINUS LAMBERTIANA RESIN 1 [hp_X]/1 N 20181231 15631-0343_d36097d7-3ae4-42cd-b439-fdea27df9ac8 15631-0343 HUMAN OTC DRUG PINUS SYLVESTRIS PINUS SYLVESTRIS PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PINUS SYLVESTRIS LEAFY TWIG 1 [hp_X]/1 N 20181231 15631-0344_613d2dda-4eaf-4371-931b-9e3f8c4fff1c 15631-0344 HUMAN OTC DRUG PIPER METHYSTICUM PIPER METHYSTICUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PIPER METHYSTICUM ROOT 1 [hp_X]/1 N 20181231 15631-0345_dcbd394f-51c8-424c-baa5-7584cf84d740 15631-0345 HUMAN OTC DRUG PIPER NIGRUM PIPER NIGRUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GREEN PEPPERCORN 1 [hp_X]/1 N 20181231 15631-0346_cf0e3751-f964-450b-b778-b51a428eb8cb 15631-0346 HUMAN OTC DRUG Pix Liquida Pix Liquida PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PINE TAR 1 [hp_X]/1 N 20181231 15631-0347_c3534eee-38f9-4f01-ac46-af19b90a98b8 15631-0347 HUMAN OTC DRUG PLANTAGO MAJOR PLANTAGO MAJOR PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PLANTAGO MAJOR 1 [hp_X]/1 N 20181231 15631-0349_96c0046b-dceb-4da9-8fa2-bf75302bfb74 15631-0349 HUMAN OTC DRUG PLATINUM METALLICUM PLATINUM METALLICUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PLATINUM 3 [hp_X]/1 N 20181231 15631-0350_33eb018b-1b83-4732-9199-6246d49b6e65 15631-0350 HUMAN OTC DRUG PLATINUM MURIATICUM PLATINUM MURIATICUM PELLET ORAL 20151106 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PLATINIC CHLORIDE HEXAHYDRATE 3 [hp_X]/1 N 20181231 15631-0351_09ed1b70-f032-45aa-a7e3-54ad7ba2b14c 15631-0351 HUMAN OTC DRUG PLUMBUM ACETICUM PLUMBUM ACETICUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LEAD ACETATE ANHYDROUS 6 [hp_X]/1 N 20181231 15631-0352_c56656c0-2ff0-4968-8e70-94d83b91955b 15631-0352 HUMAN OTC DRUG PLUMBUM IODATUM PLUMBUM IODATUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LEAD IODIDE 1 [hp_X]/1 N 20181231 15631-0353_67d7e25a-72fe-4cf0-9495-5ed466213505 15631-0353 HUMAN OTC DRUG PLUMBUM METALLICUM PLUMBUM METALLICUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LEAD 6 [hp_X]/1 N 20181231 15631-0354_441e0fb1-2904-465f-90f0-fd19895acec2 15631-0354 HUMAN OTC DRUG PODOPHYLLUM PELTATUM PODOPHYLLUM PELTATUM PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PODOPHYLLUM 3 [hp_X]/1 N 20181231 15631-0355_688a7305-2f0b-4a45-8d46-3cc232e3062f 15631-0355 HUMAN OTC DRUG POLYPORUS PINICOLA POLYPORUS PINICOLA PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FOMITOPSIS PINICOLA FRUITING BODY 2 [hp_X]/1 N 20181231 15631-0356_140ee4a6-5373-47e2-a1e8-2f3ed54bb3fb 15631-0356 HUMAN OTC DRUG POTHOS FOETIDUS POTHOS FOETIDUS PELLET ORAL 20150912 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SYMPLOCARPUS FOETIDUS ROOT 1 [hp_X]/1 N 20181231 15631-0357_f0d692b6-ff1b-49de-8713-d655f819a905 15631-0357 HUMAN OTC DRUG PULSATILLA PULSATILLA PELLET ORAL 20150914 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PULSATILLA VULGARIS 1 [hp_X]/1 N 20181231 15631-0358_0ca0776b-0662-4d01-b7da-8c906f1ded26 15631-0358 HUMAN OTC DRUG PYROGENIUM PYROGENIUM PELLET ORAL 20150914 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RANCID BEEF 12 [hp_X]/1 N 20181231 15631-0359_e8381f81-21b4-4e07-8323-bdc599679bb7 15631-0359 HUMAN OTC DRUG QUASSIA AMARA QUASSIA AMARA PELLET ORAL 20151005 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc QUASSIA AMARA WOOD 1 [hp_X]/1 N 20181231 15631-0360_42e3bdcb-630c-4d93-b6e8-5379e1c1eadc 15631-0360 HUMAN OTC DRUG QUEBRACHO QUEBRACHO PELLET ORAL 20151005 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ASPIDOSPERMA QUEBRACHO-BLANCO BARK 1 [hp_X]/1 N 20181231 15631-0361_88e4400b-1fe5-405f-9845-747d27003fbd 15631-0361 HUMAN OTC DRUG QUEBRACHO QUEBRACHO PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ASPIDOSPERMA QUEBRACHO-BLANCO BARK 1 [hp_X]/1 N 20181231 15631-0362_237ae750-3743-4e5b-83e4-cf3670dd2c03 15631-0362 HUMAN OTC DRUG QUERCUS GLANDIUM SPIRITUS QUERCUS GLANDIUM SPIRITUS PELLET ORAL 20151105 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc QUERCUS ROBUR NUT 1 [hp_X]/1 N 20181231 15631-0363_99b200ef-9c01-4f54-903d-75eef04fcb4f 15631-0363 HUMAN OTC DRUG RADIUM BROMATUM RADIUM BROMATUM PELLET ORAL 20151105 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RADIUM BROMIDE 8 [hp_X]/1 N 20181231 15631-0364_7fec3785-2481-44b4-ba85-d533bb9f3746 15631-0364 HUMAN OTC DRUG RANUNCULUS BULBOSUS RANUNCULUS BULBOSUS PELLET ORAL 20151105 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RANUNCULUS BULBOSUS 3 [hp_X]/1 N 20181231 15631-0365_389acc5a-e1ca-4327-b5eb-5c44bba889a8 15631-0365 HUMAN OTC DRUG RAPHANUS SATIVUS RAPHANUS SATIVUS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RADISH 2 [hp_X]/1 N 20181231 15631-0366_c416d1a1-0de8-415d-b422-45390ac424f5 15631-0366 HUMAN OTC DRUG RATANHIA RATANHIA PELLET ORAL 20151105 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc KRAMERIA LAPPACEA ROOT 1 [hp_X]/1 N 20181231 15631-0367_0542004c-1d46-4371-a145-c921d394cdb4 15631-0367 HUMAN OTC DRUG RAUWOLFIA SERPENTINA RAUWOLFIA SERPENTINA PELLET ORAL 20151105 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RAUWOLFIA SERPENTINA 6 [hp_X]/1 N 20181231 15631-0368_9b0545dd-3e40-420a-a21e-7d8e1febd4be 15631-0368 HUMAN OTC DRUG RHAMNUS FRANGULA RHAMNUS FRANGULA PELLET ORAL 20151105 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FRANGULA ALNUS BARK 2 [hp_X]/1 N 20181231 15631-0369_f624e187-a7a6-47d7-a16f-a5945c2ba7f8 15631-0369 HUMAN OTC DRUG RHEUM OFFICINALE RHEUM OFFICINALE PELLET ORAL 20151105 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RHEUM OFFICINALE ROOT 1 [hp_X]/1 N 20181231 15631-0370_06ee7a54-5292-496f-9e93-4ece5bcf5b92 15631-0370 HUMAN OTC DRUG RHODIUM METALLICUM RHODIUM METALLICUM PELLET ORAL 20151029 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RHODIUM 2 [hp_X]/1 N 20181231 15631-0371_91fddaf2-66db-4bfc-b7ce-3f71ff15ed57 15631-0371 HUMAN OTC DRUG RHODODENDRON CHRYSANTHUM RHODODENDRON CHRYSANTHUM PELLET ORAL 20151029 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RHODODENDRON AUREUM LEAF 3 [hp_X]/1 N 20181231 15631-0372_6e5d96c2-2b9c-40c8-a862-29867a0bb58c 15631-0372 HUMAN OTC DRUG RHUS AROMATICA RHUS AROMATICA PELLET ORAL 20151029 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RHUS AROMATICA ROOT BARK 3 [hp_X]/1 N 20181231 15631-0373_b24de158-a7c9-4151-a5db-3a39d5c579a9 15631-0373 HUMAN OTC DRUG RHUS GLABRA RHUS GLABRA PELLET ORAL 20151029 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RHUS GLABRA TOP 3 [hp_X]/1 N 20181231 15631-0374_ab6cb32a-3c64-4958-baeb-ab8c37100884 15631-0374 HUMAN OTC DRUG RHUS TOXICODENDRON RHUS TOXICODENDRON PELLET ORAL 20151030 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TOXICODENDRON PUBESCENS LEAF 3 [hp_X]/1 N 20181231 15631-0375_acf43044-1c9e-4e8f-9c23-36bc0a78848e 15631-0375 HUMAN OTC DRUG RICINUS COMMUNIS RICINUS COMMUNIS PELLET ORAL 20151030 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RICINUS COMMUNIS SEED 1 [hp_X]/1 N 20181231 15631-0376_8e822d9f-4e9e-4ddb-8e1e-7258a340a3cf 15631-0376 HUMAN OTC DRUG ROBINIA PSEUDOACACIA ROBINIA PSEUDOACACIA PELLET ORAL 20151029 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ROBINIA PSEUDOACACIA BARK 1 [hp_X]/1 N 20181231 15631-0377_3f78546a-e6e7-4533-94e7-a09aca731ede 15631-0377 HUMAN OTC DRUG RUMEX ACETOSA RUMEX ACETOSA PELLET ORAL 20151029 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RUMEX ACETOSA LEAF 1 [hp_X]/1 N 20181231 15631-0378_3528b0af-6fe0-4eca-aea8-416ddf06d63b 15631-0378 HUMAN OTC DRUG RUMEX CRISPUS RUMEX CRISPUS PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RUMEX CRISPUS ROOT 1 [hp_X]/1 N 20181231 15631-0379_613b8fe4-b5e2-4d5f-ab56-aa13c2994233 15631-0379 HUMAN OTC DRUG RUTA GRAVEOLENS RUTA GRAVEOLENS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RUTA GRAVEOLENS FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0380_aa714ddf-87b6-4260-b1fa-7d646889141c 15631-0380 HUMAN OTC DRUG SABADILLA SABADILLA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SCHOENOCAULON OFFICINALE SEED 1 [hp_X]/1 N 20181231 15631-0381_af8dee1b-b0ca-47b4-95f8-3c73bb948888 15631-0381 HUMAN OTC DRUG SABAL SERRULATA SABAL SERRULATA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SAW PALMETTO 1 [hp_X]/1 N 20181231 15631-0382_3917db6b-df15-416c-910c-29e7e7cea758 15631-0382 HUMAN OTC DRUG SABINA SABINA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc JUNIPERUS SABINA LEAFY TWIG 3 [hp_X]/1 N 20181231 15631-0383_45d63067-26e1-4b19-aced-a6e43f4e9e88 15631-0383 HUMAN OTC DRUG SACCHARUM LACTIS SACCHARUM LACTIS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LACTOSE, UNSPECIFIED FORM 1 [hp_X]/1 N 20181231 15631-0384_ff5a1036-51d4-41b1-8a3d-a97b35a6d95c 15631-0384 HUMAN OTC DRUG SALICYLICUM ACIDUM SALICYLICUM ACIDUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SALICYLIC ACID 3 [hp_X]/1 N 20181231 15631-0385_f4f612fd-97d2-40aa-a70d-ef71e711b2e2 15631-0385 HUMAN OTC DRUG SALIX NIGRA SALIX NIGRA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SALIX NIGRA BARK 1 [hp_X]/1 N 20181231 15631-0386_09e8f68d-90ea-4d78-aa49-12759bca7768 15631-0386 HUMAN OTC DRUG SALVIA OFFICINALIS SALVIA OFFICINALIS PELLET ORAL 20151030 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SAGE 1 [hp_X]/1 N 20181231 15631-0387_19eecf62-64ac-43f7-bca4-8314719179a7 15631-0387 HUMAN OTC DRUG SAMBUCUS CANADENSIS SAMBUCUS CANADENSIS PELLET ORAL 20150905 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SAMBUCUS CANADENSIS FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0388_f97bf689-5357-478d-8c3a-4b3457c6e221 15631-0388 HUMAN OTC DRUG SAMBUCUS NIGRA SAMBUCUS NIGRA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SAMBUCUS NIGRA FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0389_8dc85a59-a6b0-413b-abe9-149640e7fb82 15631-0389 HUMAN OTC DRUG SANGUINARIA CANADENSIS SANGUINARIA CANADENSIS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SANGUINARIA CANADENSIS ROOT 1 [hp_X]/1 N 20181231 15631-0390_a28f25fd-1b86-4d3d-9747-55b5cfacf0b1 15631-0390 HUMAN OTC DRUG SANTONINUM SANTONINUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SANTONIN 6 [hp_X]/1 N 20181231 15631-0392_13bf55e5-a84b-41d0-8dd9-20b0a8e95e86 15631-0392 HUMAN OTC DRUG SARCOLACTICUM ACIDUM SARCOLACTICUM ACIDUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LACTIC ACID, L- 2 [hp_X]/1 N 20181231 15631-0393_f639d78c-cefc-46e3-b22a-59a09702a51b 15631-0393 HUMAN OTC DRUG SARSAPARILLA SARSAPARILLA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SMILAX REGELII ROOT 1 [hp_X]/1 N 20181231 15631-0394_d8557ac6-1573-4b76-947c-b2a185a3a8b3 15631-0394 HUMAN OTC DRUG SCROPHULARIA NODOSA SCROPHULARIA NODOSA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SCROPHULARIA NODOSA 1 [hp_X]/1 N 20181231 15631-0395_e571a141-eb81-4815-aa9b-d3e2c64cce9a 15631-0395 HUMAN OTC DRUG SCUTELLARIA LATERIFLORA SCUTELLARIA LATERIFLORA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SCUTELLARIA LATERIFLORA 1 [hp_X]/1 N 20181231 15631-0396_69cedcad-5b0d-4010-8d47-372ba810ea9d 15631-0396 HUMAN OTC DRUG SECALE CORNUTUM SECALE CORNUTUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CLAVICEPS PURPUREA SCLEROTIUM 3 [hp_X]/1 N 20181231 15631-0397_08511ac3-be87-40bb-ac2f-a552b0c419dd 15631-0397 HUMAN OTC DRUG SELENIUM METALLICUM SELENIUM METALLICUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SELENIUM 6 [hp_X]/1 N 20181231 15631-0398_8fd5326d-71ec-49d8-b2eb-6b14fbbc7d5a 15631-0398 HUMAN OTC DRUG SENECIO AUREUS SENECIO AUREUS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PACKERA AUREA 1 [hp_X]/1 N 20181231 15631-0399_42ca2cbb-0412-405a-8169-4ecfc97e2818 15631-0399 HUMAN OTC DRUG SENECIO JACOBAEA SENECIO JACOBAEA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc JACOBAEA VULGARIS 1 [hp_X]/1 N 20181231 15631-0400_0dea804f-5846-42ac-8bd7-6521423ff445 15631-0400 HUMAN OTC DRUG SENEGA OFFICINALIS SENEGA OFFICINALIS PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POLYGALA SENEGA ROOT 1 [hp_X]/1 N 20181231 15631-0401_f6b47bb5-2e3d-427c-b860-df7dfbfc436d 15631-0401 HUMAN OTC DRUG SENNA SENNA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SENNA LEAF 1 [hp_X]/1 N 20181231 15631-0402_0c184de0-c65d-4e40-95a2-66e25a4bb40e 15631-0402 HUMAN OTC DRUG SEPIA SEPIA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SEPIA OFFICINALIS JUICE 1 [hp_X]/1 N 20181231 15631-0404_8e9683a0-5608-4cf6-8cdc-13cfc199498f 15631-0404 HUMAN OTC DRUG SILICEA SILICEA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SILICON DIOXIDE 2 [hp_X]/1 N 20181231 15631-0405_80b37293-a0e2-46e7-90f2-2f3e463624b0 15631-0405 HUMAN OTC DRUG SINAPIS NIGRA SINAPIS NIGRA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BLACK MUSTARD SEED 1 [hp_X]/1 N 20181231 15631-0406_7e80246a-dbbc-42d7-aa82-f1f20f76e0a1 15631-0406 HUMAN OTC DRUG SKATOLUM SKATOLUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SKATOLE 4 [hp_X]/1 N 20181231 15631-0407_949d920b-0624-4897-a306-16bf2b70ec3f 15631-0407 HUMAN OTC DRUG SOLANUM NIGRUM SOLANUM NIGRUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SOLANUM NIGRUM WHOLE 3 [hp_X]/1 N 20181231 15631-0408_ddd51f79-6fa3-43e0-a3b9-e1799fb7adf8 15631-0408 HUMAN OTC DRUG SOLIDAGO VIRGAUREA SOLIDAGO VIRGAUREA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SOLIDAGO VIRGAUREA FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0410_9fc9ef0e-517e-4e94-a640-cfae24fe0e02 15631-0410 HUMAN OTC DRUG SPONGIA TOSTA SPONGIA TOSTA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SPONGIA OFFICINALIS SKELETON, ROASTED 1 [hp_X]/1 N 20181231 15631-0411_ce45ba8c-c833-4f9e-aa56-2f2b60bb674e 15631-0411 HUMAN OTC DRUG STANNUM IODATUM STANNUM IODATUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc STANNOUS IODIDE 3 [hp_X]/1 N 20181231 15631-0412_ee9cf763-7bcf-44e6-b58c-5680e6b92b40 15631-0412 HUMAN OTC DRUG STANNUM METALLICUM STANNUM METALLICUM PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TIN 3 [hp_X]/1 N 20181231 15631-0413_f92a52c9-ada6-4872-83c0-d94f4f67258f 15631-0413 HUMAN OTC DRUG STAPHYSAGRIA STAPHYSAGRIA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DELPHINIUM STAPHISAGRIA SEED 3 [hp_X]/1 N 20181231 15631-0414_16f2fe3f-350a-4adc-86b7-045f608c8c41 15631-0414 HUMAN OTC DRUG STELLARIA MEDIA STELLARIA MEDIA PELLET ORAL 20151002 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc STELLARIA MEDIA 1 [hp_X]/1 N 20181231 15631-0415_81a50110-f140-496d-92bf-8f42c8f7b4a3 15631-0415 HUMAN OTC DRUG STICTA PULMONARIA STICTA PULMONARIA PELLET ORAL 20151103 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LOBARIA PULMONARIA 1 [hp_X]/1 N 20181231 15631-0416_2769f606-4c38-4e00-808a-cf731c381593 15631-0416 HUMAN OTC DRUG STIGMATA MAIDIS STIGMATA MAIDIS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CORN SILK 1 [hp_X]/1 N 20181231 15631-0417_2519bc24-e468-4e69-a8c2-4d1693896a82 15631-0417 HUMAN OTC DRUG STRAMONIUM STRAMONIUM PELLET ORAL 20151103 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DATURA STRAMONIUM 6 [hp_X]/1 N 20181231 15631-0418_1075be25-0e67-4479-846d-681826f367f5 15631-0418 HUMAN OTC DRUG STRONTIUM BROMATUM STRONTIUM BROMATUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc STRONTIUM BROMIDE 6 [hp_X]/1 N 20181231 15631-0419_baff9d1c-a2ea-4386-b66a-db502553ee55 15631-0419 HUMAN OTC DRUG STROPHANTHUS HISPIDUS STROPHANTHUS HISPIDUS PELLET ORAL 20151103 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc STROPHANTHUS HISPIDUS SEED 3 [hp_X]/1 N 20181231 15631-0420_3c1405b6-9967-408b-bc62-e648436b7718 15631-0420 HUMAN OTC DRUG SULPHUR SULPHUR PELLET ORAL 20151103 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SULFUR 1 [hp_X]/1 N 20181231 15631-0421_eeed84a6-79e2-4e02-bfb7-594741dfdb31 15631-0421 HUMAN OTC DRUG SULPHUR IODATUM SULPHUR IODATUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SULFUR IODIDE 3 [hp_X]/1 N 20181231 15631-0422_d410bf31-2973-4f8c-8fbf-d27519bab408 15631-0422 HUMAN OTC DRUG SULPHURICUM ACIDUM SULPHURICUM ACIDUM PELLET ORAL 20151103 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SULFURIC ACID 6 [hp_X]/1 N 20181231 15631-0423_f33d4dbd-68ae-4a12-96cd-f468d5977381 15631-0423 HUMAN OTC DRUG SUMBUL SUMBUL PELLET ORAL 20151103 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERULA SUMBUL ROOT 1 [hp_X]/1 N 20181231 15631-0424_c9463cf0-200e-4dde-8778-632eae6d1c34 15631-0424 HUMAN OTC DRUG SYMPHYTUM OFFICINALE SYMPHYTUM OFFICINALE PELLET ORAL 20151103 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COMFREY ROOT 1 [hp_X]/1 N 20181231 15631-0425_a05dd256-0f47-48df-aae1-05048cef75de 15631-0425 HUMAN OTC DRUG SYZYGIUM JAMBOLANUM SYZYGIUM JAMBOLANUM PELLET ORAL 20151103 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc JUNIPERUS SABINA LEAFY TWIG 3 [hp_X]/1 N 20181231 15631-0426_8d65145c-49b7-4020-b98d-0873ed468361 15631-0426 HUMAN OTC DRUG TABACUM TABACUM PELLET ORAL 20151103 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TOBACCO LEAF 3 [hp_X]/1 N 20181231 15631-0427_f3488bc6-b9d8-4d08-a0be-523c0297739d 15631-0427 HUMAN OTC DRUG TANACETUM VULGARE TANACETUM VULGARE PELLET ORAL 20151104 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TANACETUM VULGARE TOP 3 [hp_X]/1 N 20181231 15631-0428_1f84a31f-1d57-42d9-b473-ab1411bd6054 15631-0428 HUMAN OTC DRUG TANNICUM ACIDUM TANNICUM ACIDUM PELLET ORAL 20151104 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TANNIC ACID 3 [hp_X]/1 N 20181231 15631-0429_8351becd-4461-4e5e-800e-dd8c5afbc26b 15631-0429 HUMAN OTC DRUG TARENTULA CUBENSIS TARENTULA CUBENSIS PELLET ORAL 20151106 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CITHARACANTHUS SPINICRUS 8 [hp_X]/1 N 20181231 15631-0430_196c7db4-de5d-4aba-9d0f-594a3d0f1d0d 15631-0430 HUMAN OTC DRUG TARENTULA CUBENSIS TARENTULA CUBENSIS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CITHARACANTHUS SPINICRUS 8 [hp_X]/1 N 20181231 15631-0431_3c83de0e-b6dd-4937-be37-b80580768193 15631-0431 HUMAN OTC DRUG TARENTULA HISPANA TARENTULA HISPANA PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LYCOSA TARANTULA 8 [hp_X]/1 N 20181231 15631-0432_0a59266d-713d-4a3d-9b17-a61cf7f718a2 15631-0432 HUMAN OTC DRUG TARTARICUM ACIDUM TARTARICUM ACIDUM PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TARTARIC ACID 1 [hp_X]/1 N 20181231 15631-0433_efa5c5c4-f4f2-4155-ae34-e6ddbabee3a6 15631-0433 HUMAN OTC DRUG TELLURIUM METALLICUM TELLURIUM METALLICUM PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TELLURIUM 3 [hp_X]/1 N 20181231 15631-0434_56713dce-29e6-4c21-881a-e3e534e90d5b 15631-0434 HUMAN OTC DRUG TEREBINTHINA TEREBINTHINA PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TURPENTINE OIL 2 [hp_X]/1 N 20181231 15631-0435_4aee9a7b-39ba-44ed-af73-ef6358930e66 15631-0435 HUMAN OTC DRUG TEUCRIUM MARUM TEUCRIUM MARUM PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TEUCRIUM MARUM 1 [hp_X]/1 N 20181231 15631-0436_19da3ee5-67e9-46db-bb99-1b235da416cd 15631-0436 HUMAN OTC DRUG THALLIUM METALLICUM THALLIUM METALLICUM PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc THALLIUM 6 [hp_X]/1 N 20181231 15631-0437_adf832d8-481d-4a06-a5a1-45ef0974de52 15631-0437 HUMAN OTC DRUG THASPIUM AUREUM THASPIUM AUREUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ZIZIA AUREA ROOT 1 [hp_X]/1 N 20181231 15631-0438_a63b88e5-6c60-4d0b-ab87-31559d7326d2 15631-0438 HUMAN OTC DRUG THEA SINENSIS THEA SINENSIS PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GREEN TEA LEAF 1 [hp_X]/1 N 20181231 15631-0439_52de63a9-17e3-4c65-bbad-eb421b67ca4c 15631-0439 HUMAN OTC DRUG THERIDION THERIDION PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc THERIDION CURASSAVICUM 8 [hp_X]/1 N 20181231 15631-0440_b1052352-cf66-4fb9-9d64-8cce446c2e1b 15631-0440 HUMAN OTC DRUG THIOSINAMINUM THIOSINAMINUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALLYLTHIOUREA 3 [hp_X]/1 N 20181231 15631-0441_b127e83d-7bb8-4600-81a7-02ab9ec95f15 15631-0441 HUMAN OTC DRUG THLASPI BURSA-PASTORIS THLASPI BURSA-PASTORIS PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CAPSELLA BURSA-PASTORIS 1 [hp_X]/1 N 20181231 15631-0442_feecaf87-d433-48e0-9bdc-80e7fe93bab0 15631-0442 HUMAN OTC DRUG THUJA OCCIDENTALIS THUJA OCCIDENTALIS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc THUJA OCCIDENTALIS LEAFY TWIG 1 [hp_X]/1 N 20181231 15631-0443_18aba704-37af-4d9a-8509-7105587a850d 15631-0443 HUMAN OTC DRUG THYMUS SERPYLLUM THYMUS SERPYLLUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc THYMUS SERPYLLUM 1 [hp_X]/1 N 20181231 15631-0444_ffce582e-4fa8-4dc8-89ad-911c993dacf5 15631-0444 HUMAN OTC DRUG TILIA EUROPAEA TILIA EUROPAEA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TILIA X EUROPAEA FLOWER 1 [hp_X]/1 N 20181231 15631-0445_30a0f262-70d4-4496-adaa-5530df924ddc 15631-0445 HUMAN OTC DRUG TITANIUM METALLICUM TITANIUM METALLICUM PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TITANIUM 3 [hp_X]/1 N 20181231 15631-0446_e178df60-eb30-4196-bcf1-53ccbb3a4f03 15631-0446 HUMAN OTC DRUG TRIFOLIUM PRATENSE TRIFOLIUM PRATENSE PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc JUNIPERUS SABINA LEAFY TWIG 1 [hp_X]/1 N 20181231 15631-0447_fbe7f222-72d1-43ef-b605-1609c32e4f6a 15631-0447 HUMAN OTC DRUG TRIFOLIUM REPENS TRIFOLIUM REPENS PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIFOLIUM REPENS FLOWER 1 [hp_X]/1 N 20181231 15631-0448_586f13ce-6f94-4825-9d6e-e2d105b08848 15631-0448 HUMAN OTC DRUG URANIUM NITRICUM URANIUM NITRICUM PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc URANYL NITRATE HEXAHYDRATE 8 [hp_X]/1 N 20181231 15631-0449_e8d035d7-e8e8-4235-a1a2-31b2124bfacc 15631-0449 HUMAN OTC DRUG UREA UREA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc UREA 1 [hp_X]/1 N 20181231 15631-0450_caaa4338-fb66-427f-a550-7b1b9b845609 15631-0450 HUMAN OTC DRUG URTICA URENS URTICA URENS PELLET ORAL 20151102 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc URTICA URENS 1 [hp_X]/1 N 20181231 15631-0451_8f3404a8-8354-4028-91f5-9670f5dadaf0 15631-0451 HUMAN OTC DRUG USTILAGO MAIDIS USTILAGO MAIDIS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc USTILAGO MAYDIS 3 [hp_X]/1 N 20181231 15631-0452_df17fb41-053b-4567-a147-eebe6e37f1c9 15631-0452 HUMAN OTC DRUG UVA URSI UVA URSI PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARCTOSTAPHYLOS UVA-URSI LEAF 1 [hp_X]/1 N 20181231 15631-0453_e7bd39b9-0502-40b8-be3a-b1de842e9e0b 15631-0453 HUMAN OTC DRUG VALERIANA OFFICINALIS VALERIANA OFFICINALIS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VALERIAN 1 [hp_X]/1 N 20181231 15631-0454_83b45607-dfbf-47e8-a151-7668bfe8fa5c 15631-0454 HUMAN OTC DRUG VANADIUM METALLICUM SABINA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VANADIUM 6 [hp_X]/1 N 20181231 15631-0455_09b37f0e-1d14-4e8d-8591-fd94ce714e14 15631-0455 HUMAN OTC DRUG VERATRUM ALBUM VERATRUM ALBUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VERATRUM ALBUM ROOT 3 [hp_X]/1 N 20181231 15631-0456_22334016-bb73-4578-81fc-19d43b40e040 15631-0456 HUMAN OTC DRUG VERATRUM VIRIDE VERATRUM VIRIDE PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VERATRUM VIRIDE ROOT 2 [hp_X]/1 N 20181231 15631-0457_72e39b81-97ab-4a81-8f54-302c930b7754 15631-0457 HUMAN OTC DRUG VERBASCUM THAPSUS VERBASCUM THAPSUS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VERBASCUM THAPSUS 1 [hp_X]/1 N 20181231 15631-0458_e86fff74-2176-4735-a2e2-0bdafd7bacf9 15631-0458 HUMAN OTC DRUG VERBENA HASTATA VERBENA HASTATA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VERBENA HASTATA TOP 1 [hp_X]/1 N 20181231 15631-0459_b20da31c-b89f-44b3-b9dd-ebc09176531e 15631-0459 HUMAN OTC DRUG VIBURNUM OPULUS VIBURNUM OPULUS PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VIBURNUM OPULUS BARK 1 [hp_X]/1 N 20181231 15631-0460_2b60d608-7f28-4c2e-965e-8af31d078f5f 15631-0460 HUMAN OTC DRUG VINCA MINOR VINCA MINOR PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VINCA MINOR 3 [hp_X]/1 N 20181231 15631-0461_1e098e61-1f00-40d1-a2cd-e4ede33887e8 15631-0461 HUMAN OTC DRUG VIOLA ODORATA VIOLA ODORATA PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VIOLA ODORATA 1 [hp_X]/1 N 20181231 15631-0462_78f560cc-9201-400f-bcef-b79dd18c0007 15631-0462 HUMAN OTC DRUG VIOLA TRICOLOR VIOLA TRICOLOR PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VIOLA TRICOLOR 1 [hp_X]/1 N 20181231 15631-0463_b48f69f4-e0c3-4341-9d1f-31564fe21c19 15631-0463 HUMAN OTC DRUG VISCUM ALBUM VISCUM ALBUM PELLET ORAL 20151031 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VISCUM ALBUM FRUITING TOP 3 [hp_X]/1 N 20181231 15631-0464_342abbfa-587f-48ae-b4c9-0c1b81a62e44 15631-0464 HUMAN OTC DRUG WYETHIA HELENIOIDES WYETHIA HELENIOIDES PELLET ORAL 20151101 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc WYETHIA HELENIOIDES ROOT 1 [hp_X]/1 N 20181231 15631-0465_26624913-a819-4886-9bcc-f7230457915c 15631-0465 HUMAN OTC DRUG XANTHOXYLUM FRAXINEUM XANTHOXYLUM FRAXINEUM PELLET ORAL 20151101 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ZANTHOXYLUM AMERICANUM BARK 1 [hp_X]/1 N 20181231 15631-0466_78d1982a-b321-4eed-9d88-54f26229d3f1 15631-0466 HUMAN OTC DRUG XRAY XRAY PELLET ORAL 20151101 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALCOHOL, X-RAY EXPOSED (1000 RAD) 6 [hp_X]/1 N 20181231 15631-0467_1db3e36b-1139-4225-9edf-9c65b3485cd0 15631-0467 HUMAN OTC DRUG ZINCUM BROMATUM ZINCUM BROMATUM PELLET ORAL 20151101 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ZINC BROMIDE 3 [hp_X]/1 N 20181231 15631-0468_0f8a4eb5-f62e-4381-82da-8a404ad9739b 15631-0468 HUMAN OTC DRUG ZINCUM CARBONICUM ZINCUM CARBONICUM PELLET ORAL 20151101 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ZINC CARBONATE 3 [hp_X]/1 N 20181231 15631-0469_7c8860b3-ed69-4ce9-93b0-5a6d5e18c586 15631-0469 HUMAN OTC DRUG ZINCUM METALLICUM ZINCUM METALLICUM PELLET ORAL 20151101 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ZINC 3 [hp_X]/1 N 20181231 15631-0470_980ea854-4615-414a-aaa9-a8414ed54d49 15631-0470 HUMAN OTC DRUG ZINCUM MURIATICUM ZINCUM MURIATICUM PELLET ORAL 20151101 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ZINC CHLORIDE 6 [hp_X]/1 N 20181231 15631-0471_758da93f-0e42-4f96-815d-45865d58d224 15631-0471 HUMAN OTC DRUG ZINCUM PHOSPHORATUM ZINCUM PHOSPHORATUM PELLET ORAL 20151101 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ZINC PHOSPHIDE 6 [hp_X]/1 N 20181231 15631-0472_01395dc9-d9dc-4b4e-baf9-976e0dd82800 15631-0472 HUMAN OTC DRUG ZINCUM SULPHURICUM ZINCUM SULPHURICUM PELLET ORAL 20151101 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ZINC SULFATE HEPTAHYDRATE 3 [hp_X]/1 N 20181231 15631-0473_e3871dfa-6448-4a99-adfe-9cb68f9c0ff9 15631-0473 HUMAN OTC DRUG ZINGIBER OFFICINALE ZINGIBER OFFICINALE PELLET ORAL 20151101 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GINGER 1 [hp_X]/1 N 20181231 15631-0501_186d600a-4f11-452a-87a1-45d843aee17a 15631-0501 HUMAN OTC DRUG ABIES CANADENSIS ABIES CANADENSIS TABLET ORAL 20151229 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TSUGA CANADENSIS BARK 1 [hp_X]/1 N 20181231 15631-0502_597240d8-13f2-4575-a4a6-1b79c14cf897 15631-0502 HUMAN OTC DRUG ACONITUM NAPELLUS ACONITUM NAPELLUS TABLET ORAL 20151229 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ACONITUM NAPELLUS 3 [hp_X]/1 N 20181231 15631-0503_4eeda2d7-b942-4ac0-bc75-ca3dc7716697 15631-0503 HUMAN OTC DRUG ACTAEA SPICATA ACTAEA SPICATA TABLET ORAL 20151229 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ACTAEA SPICATA ROOT 1 [hp_X]/1 N 20181231 15631-0504_848896c8-1fea-4e9d-9b50-73bf25af69f1 15631-0504 HUMAN OTC DRUG AESCULUS HIPPOCASTANUM AESCULUS HIPPOCASTANUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HORSE CHESTNUT 2 [hp_X]/1 N 20181231 15631-0505_b8667a98-9e87-4bfa-83c1-f05d47cfbd9b 15631-0505 HUMAN OTC DRUG AGARICUS MUSCARIUS AGARICUS MUSCARIUS TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AMANITA MUSCARIA FRUITING BODY 2 [hp_X]/1 N 20181231 15631-0506_9809f8eb-c650-4700-b1c9-49005333aeb5 15631-0506 HUMAN OTC DRUG AGNUS CASTUS AGNUS CASTUS TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHASTE TREE 1 [hp_X]/1 N 20181231 15631-0507_e47dac17-ea46-46ed-b3ae-75cd921afe6e 15631-0507 HUMAN OTC DRUG ALFALFA ALFALFA TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALFALFA 1 [hp_X]/1 N 20181231 15631-0508_06bc77d6-77ba-4911-927e-9a738aa46a9a 15631-0508 HUMAN OTC DRUG ALLIUM CEPA ALLIUM CEPA TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ONION 1 [hp_X]/1 N 20181231 15631-0509_00c9c670-2a64-4f9a-b47e-6762d9f9e97d 15631-0509 HUMAN OTC DRUG ALOE SOCOTRINA ALOE SOCOTRINA TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALOE 1 [hp_X]/1 N 20181231 15631-0510_ae126e71-c464-421c-89f8-85994898fcf5 15631-0510 HUMAN OTC DRUG ALUMINA ALUMINA TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALUMINUM OXIDE 3 [hp_X]/1 N 20181231 15631-0511_dc774477-c03d-4fc5-9005-83e557ee8b4c 15631-0511 HUMAN OTC DRUG ANACARDIUM OCCIDENTALE ANACARDIUM OCCIDENTALE TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ANACARDIUM OCCIDENTALE FRUIT 3 [hp_X]/1 N 20181231 15631-0512_541a3adc-2263-4072-99cb-b5c753ba38d5 15631-0512 HUMAN OTC DRUG ANACARDIUM ORIENTALE ANACARDIUM ORIENTALE TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SEMECARPUS ANACARDIUM JUICE 3 [hp_X]/1 N 20181231 15631-0513_e1d0bd8c-9b58-4486-81b5-48cd84e15db0 15631-0513 HUMAN OTC DRUG ANTIMONIUM CRUDUM ANTIMONIUM CRUDUM TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ANTIMONY TRISULFIDE 3 [hp_X]/1 N 20181231 15631-0514_ce63aa91-0daf-4cf6-a6b3-4dffd8263418 15631-0514 HUMAN OTC DRUG ANTIMONIUM TARTARICUM ANTIMONIUM TARTARICUM TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ANTIMONY POTASSIUM TARTRATE 3 [hp_X]/1 N 20181231 15631-0515_618eec6e-91e2-461b-81c7-4b790eb741fe 15631-0515 HUMAN OTC DRUG APIS MELLIFICA APIS MELLIFICA TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc APIS MELLIFERA 1 [hp_X]/1 N 20181231 15631-0516_0bb3685e-afe2-41ff-8391-8f5e88a54b4b 15631-0516 HUMAN OTC DRUG APOCYNUM CANNABINUM APOCYNUM CANNABINUM TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc APOCYNUM CANNABINUM ROOT 3 [hp_X]/1 N 20181231 15631-0517_dbe2f1cd-fdab-44cc-bfdd-ef16e5b49207 15631-0517 HUMAN OTC DRUG ARALIA QUINQUEFOLIA ARALIA QUINQUEFOLIA TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AMERICAN GINSENG 1 [hp_X]/1 N 20181231 15631-0518_090fabb8-cbc5-4173-9e8c-1ff81de2764e 15631-0518 HUMAN OTC DRUG ARALIA RACEMOSA ARALIA RACEMOSA TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARALIA RACEMOSA ROOT 1 [hp_X]/1 N 20181231 15631-0519_2fe8da5d-7205-412f-a311-01e2470190c0 15631-0519 HUMAN OTC DRUG ARGENTUM METALLICUM ARGENTUM METALLICUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SILVER 3 [hp_X]/1 N 20181231 15631-0520_97ff8fcb-3f02-4211-ad80-d728764823ff 15631-0520 HUMAN OTC DRUG ARGENTUM NITRICUM ARGENTUM NITRICUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SILVER NITRATE 6 [hp_X]/1 N 20181231 15631-0521_625e0a3a-55c7-4a85-a516-606c3ad60ed0 15631-0521 HUMAN OTC DRUG ARNICA MONTANA ARNICA MONTANA TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARNICA MONTANA 3 [hp_X]/1 N 20181231 15631-0522_242a93f0-b237-4835-ad8c-d427ad497b60 15631-0522 HUMAN OTC DRUG ARSENICUM ALBUM ARSENICUM ALBUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARSENIC TRIOXIDE 6 [hp_X]/1 N 20181231 15631-0523_82ae24be-87cb-4a37-ba06-73e08c4284ef 15631-0523 HUMAN OTC DRUG ARSENICUM BROMATUM ARSENICUM BROMATUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARSENIC TRIBROMIDE 6 [hp_X]/1 N 20181231 15631-0524_a817bb4b-b3f3-4205-aeea-3e880504586e 15631-0524 HUMAN OTC DRUG ARSENICUM IODATUN ARSENICUM IODATUN TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARSENIC TRIIODIDE 6 [hp_X]/1 N 20181231 15631-0525_8360e9f7-de06-4268-96f0-f7726e520cd9 15631-0525 HUMAN OTC DRUG ARSENICUM SULPHURATUM FLAVUM ARSENICUM SULPHURATUM FLAVUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARSENIC TRISULFIDE 6 [hp_X]/1 N 20181231 15631-0526_65914c2d-9f2d-4c19-a980-e2247bbeedcd 15631-0526 HUMAN OTC DRUG ARSENICUM SULPHURATUM RUBRUM ARSENICUM SULPHURATUM RUBRUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TETRAARSENIC TETRASULFIDE 6 [hp_X]/1 N 20181231 15631-0527_d3e02196-30a2-41cc-9ca2-1321f0860485 15631-0527 HUMAN OTC DRUG ARUM TRIPHYLLUM ARUM TRIPHYLLUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARISAEMA TRIPHYLLUM ROOT 1 [hp_X]/1 N 20181231 15631-0528_b4c84a39-5be8-4fcb-a39e-ba2db361748a 15631-0528 HUMAN OTC DRUG AURUM METALLICUM AURUM METALLICUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GOLD 3 [hp_X]/1 N 20181231 15631-0529_f4ed2e0a-960b-4a8a-bbd6-df78bb70e15d 15631-0529 HUMAN OTC DRUG AURUM MURIATICUM NATRONATUM AURUM MURIATICUM NATRONATUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM TETRACHLOROAURATE 3 [hp_X]/1 N 20181231 15631-0530_99de5f71-c0cf-40c3-a4c6-65e30437ec30 15631-0530 HUMAN OTC DRUG AVENA SATIVA AVENA SATIVA TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AVENA SATIVA FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0531_9dc18d3f-bfa5-438b-a061-14b43460f463 15631-0531 HUMAN OTC DRUG AZADIRACHTA INDICA AZADIRACHTA INDICA TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc AZADIRACHTA INDICA BARK 1 [hp_X]/1 N 20181231 15631-0532_41e661bd-1448-4d82-9e58-fc1d2cdba360 15631-0532 HUMAN OTC DRUG BADIAGA BADIAGA TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SPONGILLA LACUSTRIS 2 [hp_X]/1 N 20181231 15631-0533_6bb04ecf-f1f7-4379-bc55-1eb0beb4380b 15631-0533 HUMAN OTC DRUG BAPTISIA TINCTORIA BAPTISIA TINCTORIA TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BAPTISIA TINCTORIA ROOT 1 [hp_X]/1 N 20181231 15631-0534_45ff36f4-f845-4d98-b2e7-72889515412e 15631-0534 HUMAN OTC DRUG BARYTA CARBONICA BARYTA CARBONICA TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BARIUM CARBONATE 6 [hp_X]/1 N 20181231 15631-0535_a12ddb81-dcd6-4748-8da5-81663d5ae7af 15631-0535 HUMAN OTC DRUG BARYTA MURIATICA BARYTA MURIATICA TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BARIUM CHLORIDE DIHYDRATE 6 [hp_X]/1 N 20181231 15631-0536_9114357a-54ba-453a-b160-9db26225b347 15631-0536 HUMAN OTC DRUG BELLADONNA BELLADONNA TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ATROPA BELLADONNA 3 [hp_X]/1 N 20181231 15631-0537_df16336a-d3a8-4f3a-9a67-166d79bbed0e 15631-0537 HUMAN OTC DRUG BELLIS PERENNIS BELLIS PERENNIS TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BELLIS PERENNIS 1 [hp_X]/1 N 20181231 15631-0538_31ac8c9d-9b75-4ae8-9fa3-f2af27dc6afc 15631-0538 HUMAN OTC DRUG BERBERIS AQUIFOLIUM BERBERIS AQUIFOLIUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MAHONIA AQUIFOLIUM ROOT BARK 1 [hp_X]/1 N 20181231 15631-0539_6d9431a0-d346-4e94-adee-12b618d242e2 15631-0539 HUMAN OTC DRUG BERBERIS VULGARIS BERBERIS VULGARIS TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BERBERIS VULGARIS ROOT BARK 1 [hp_X]/1 N 20181231 15631-0540_bb0b61dc-fde6-4b59-8fe6-23b53764c7de 15631-0540 HUMAN OTC DRUG BLATTA ORIENTALIS BLATTA ORIENTALIS TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BLATTA ORIENTALIS 2 [hp_X]/1 N 20181231 15631-0541_31e32279-1a8f-46a9-a0f5-2b8b3f1794c1 15631-0541 HUMAN OTC DRUG BORAX BORAX TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM BORATE 1 [hp_X]/1 N 20181231 15631-0542_caac2afe-9588-44be-b8e9-42aa392f801c 15631-0542 HUMAN OTC DRUG BROMIUM BROMIUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BROMINE 6 [hp_X]/1 N 20181231 15631-0543_42218b60-b6eb-4470-ae40-f9cacec74f54 15631-0543 HUMAN OTC DRUG BRYONIA ALBA BRYONIA ALBA TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BRYONIA ALBA ROOT 3 [hp_X]/1 N 20181231 15631-0544_4838607d-dc1f-4efa-8907-c84f887a1951 15631-0544 HUMAN OTC DRUG CACTUS GRANDIFLORUS CACTUS GRANDIFLORUS TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SELENICEREUS GRANDIFLORUS STEM 3 [hp_X]/1 N 20181231 15631-0545_54a66e6b-fca4-4c44-97e3-78be20efbc40 15631-0545 HUMAN OTC DRUG CADMIUM SULPHURICUM CADMIUM SULPHURICUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CADMIUM SULFATE 6 [hp_X]/1 N 20181231 15631-0546_ecfb0f29-393e-4eb3-91a4-074300b248f2 15631-0546 HUMAN OTC DRUG CALADIUM SEGUINUM CALADIUM SEGUINUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DIEFFENBACHIA SEGUINE 3 [hp_X]/1 N 20181231 15631-0547_ed022902-e013-4798-900f-97fd3b22a4a5 15631-0547 HUMAN OTC DRUG CALCAREA CARBONICA CALCAREA CARBONICA TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc OYSTER SHELL CALCIUM CARBONATE, CRUDE 1 [hp_X]/1 N 20181231 15631-0548_300f4396-2869-4ce3-9e2b-c3eaa0915f49 15631-0548 HUMAN OTC DRUG CALCAREA FLUORICA CALCAREA FLUORICA TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM FLUORIDE 3 [hp_X]/1 N 20181231 15631-0549_fa02de0f-10a6-4811-a949-364889791673 15631-0549 HUMAN OTC DRUG CALCAREA PHOSPHORICA CALCAREA PHOSPHORICA TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE 1 [hp_X]/1 N 20181231 15631-0550_a1d9a153-dfdd-4273-9c31-99657e05ef13 15631-0550 HUMAN OTC DRUG CALCAREA SULPHURICA CALCAREA SULPHURICA TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM SULFATE ANHYDROUS 1 [hp_X]/1 N 20181231 15631-0551_23bd2117-f234-47bc-82c4-48b36b6c5b1b 15631-0551 HUMAN OTC DRUG CALENDULA OFFICINALIS CALENDULA OFFICINALIS TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0552_ab10654e-638d-4775-be7e-fe28f576ddc8 15631-0552 HUMAN OTC DRUG CANTHARIS CANTHARIS TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LYTTA VESICATORIA 3 [hp_X]/1 N 20181231 15631-0553_49af1501-0df3-4266-9748-9f100d3067bb 15631-0553 HUMAN OTC DRUG CARBO VEGETABILIS CARBO VEGETABILIS TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ACTIVATED CHARCOAL 1 [hp_X]/1 N 20181231 15631-0554_72b6c1b2-d080-421b-a6bc-808eb977bf0d 15631-0554 HUMAN OTC DRUG CARDUUS MARIANUS CARDUUS MARIANUS TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MILK THISTLE 1 [hp_X]/1 N 20181231 15631-0555_bcfc1f9f-a75c-4c7c-9fa0-632eaa634567 15631-0555 HUMAN OTC DRUG CAULOPHYLLUM THALICTROIDES CAULOPHYLLUM THALICTROIDES TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CAULOPHYLLUM THALICTROIDES ROOT 3 [hp_X]/1 N 20181231 15631-0556_bfbd0af4-e638-4389-a5d6-1b53805e2472 15631-0556 HUMAN OTC DRUG CAUSTICUM CAUSTICUM TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CAUSTICUM 2 [hp_X]/1 N 20181231 15631-0557_488a76fb-2a5f-4d8f-936d-a67a61afbe5d 15631-0557 HUMAN OTC DRUG CEANOTHUS AMERICANUS CEANOTHUS AMERICANUS TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CEANOTHUS AMERICANUS LEAF 1 [hp_X]/1 N 20181231 15631-0558_4d756c92-94d3-4a68-bd4e-109f40b33444 15631-0558 HUMAN OTC DRUG CHAMOMILLA CHAMOMILLA TABLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MATRICARIA RECUTITA 1 [hp_X]/1 N 20181231 15631-0559_2f72cfa9-6507-4887-87e7-86ddf3a188da 15631-0559 HUMAN OTC DRUG CHELIDONIUM MAJUS CHELIDONIUM MAJUS TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHELIDONIUM MAJUS 1 [hp_X]/1 N 20181231 15631-0560_b8c85784-72ef-49cf-92a9-d2aab3751fbf 15631-0560 HUMAN OTC DRUG CHIMAPHILA UMBELLATA CHIMAPHILA UMBELLATA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHIMAPHILA UMBELLATA 1 [hp_X]/1 N 20181231 15631-0561_429c4bd2-1d9d-4230-90a4-62166b2c866c 15631-0561 HUMAN OTC DRUG CHININUM SULPHURICUM CHININUM SULPHURICUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc QUININE SULFATE 3 [hp_X]/1 N 20181231 15631-0562_cbc2fba4-6a8d-44d1-b28e-e49fd4304bd0 15631-0562 HUMAN OTC DRUG CIMICIFUGA RACEMOSA CIMICIFUGA RACEMOSA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BLACK COHOSH 1 [hp_X]/1 N 20181231 15631-0563_102ff27c-58b1-47ce-a21f-fff3aaae4434 15631-0563 HUMAN OTC DRUG CINA CINA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARTEMISIA CINA PRE-FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0564_c38e92b0-2ae5-49b1-935d-9ed4dbdf37d3 15631-0564 HUMAN OTC DRUG CINCHONA OFFICINALIS CINCHONA OFFICINALIS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CINCHONA OFFICINALIS BARK 2 [hp_X]/1 N 20181231 15631-0565_b50abd24-fb59-44d8-91ea-9d493dd524c6 15631-0565 HUMAN OTC DRUG COCCULUS INDICUS COCCULUS INDICUS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ANAMIRTA COCCULUS SEED 3 [hp_X]/1 N 20181231 15631-0566_1d1147de-d732-4bb0-b5c7-64f0082513d5 15631-0566 HUMAN OTC DRUG COCCUS CACTI COCCUS CACTI TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PROTORTONIA CACTI 1 [hp_X]/1 N 20181231 15631-0567_5b0dfeda-9425-422d-87c9-0232ffc4eeb1 15631-0567 HUMAN OTC DRUG COLCHICUM AUTUMNALE COLCHICUM AUTUMNALE TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COLCHICUM AUTUMNALE BULB 3 [hp_X]/1 N 20181231 15631-0568_d525bd64-41c6-4751-979d-586f69efe1f0 15631-0568 HUMAN OTC DRUG COLLINSONIA CANADENSIS COLLINSONIA CANADENSIS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COLLINSONIA CANADENSIS ROOT 1 [hp_X]/1 N 20181231 15631-0569_156ae625-259f-44cd-85fa-c131f5e5b182 15631-0569 HUMAN OTC DRUG COLOCYNTHIS COLOCYNTHIS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CITRULLUS COLOCYNTHIS FRUIT PULP 3 [hp_X]/1 N 20181231 15631-0570_99c6258b-7199-465b-af2d-a54d1ecfbd69 15631-0570 HUMAN OTC DRUG CONIUM MACULATUM CONIUM MACULATUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CONIUM MACULATUM FLOWERING TOP 3 [hp_X]/1 N 20181231 15631-0571_fd119248-cdf2-40a7-bdc6-e136382aee83 15631-0571 HUMAN OTC DRUG CONVALLARIA MAJALIS CONVALLARIA MAJALIS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CONVALLARIA MAJALIS 3 [hp_X]/1 N 20181231 15631-0572_56767de0-9384-405c-8da8-e31bc3672036 15631-0572 HUMAN OTC DRUG CUPRUM METALLICUM CUPRUM METALLICUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COPPER 3 [hp_X]/1 N 20181231 15631-0573_44ff0c17-dac8-4b0b-b1a4-eff0089c07b5 15631-0573 HUMAN OTC DRUG DIGITALIS PURPUREA DIGITALIS PURPUREA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DIGITALIS 6 [hp_X]/1 N 20181231 15631-0574_a1f4d077-3485-4dce-af8f-76a355a6b216 15631-0574 HUMAN OTC DRUG DIOSCOREA VILLOSA DIOSCOREA VILLOSA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DIOSCOREA VILLOSA TUBER 1 [hp_X]/1 N 20181231 15631-0575_070feb38-5117-4d89-b384-8ec811a09562 15631-0575 HUMAN OTC DRUG DROSERA ROTUNDIFOLIA DROSERA ROTUNDIFOLIA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DROSERA ROTUNDIFOLIA 1 [hp_X]/1 N 20181231 15631-0576_330a9176-15ff-4282-a4f1-1b19179d282e 15631-0576 HUMAN OTC DRUG DULCAMARA DULCAMARA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SOLANUM DULCAMARA TOP 2 [hp_X]/1 N 20181231 15631-0577_ecfed7fc-c24e-40a8-8f61-96f5c4afef78 15631-0577 HUMAN OTC DRUG ECHINACEA ANGUSTIFOLIA ECHINACEA ANGUSTIFOLIA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ECHINACEA ANGUSTIFOLIA 1 [hp_X]/1 N 20181231 15631-0578_2237ea37-78bc-4827-9985-725ac6c4b21e 15631-0578 HUMAN OTC DRUG EQUISETUM HYEMALE EQUISETUM HYEMALE TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EQUISETUM HYEMALE 3 [hp_X]/1 N 20181231 15631-0579_37d7978f-42b2-4033-b705-8140b19cc399 15631-0579 HUMAN OTC DRUG EUPATORIUM PERFOLIATUM EUPATORIUM PERFOLIATUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EUPATORIUM PERFOLIATUM FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0580_2b649dc0-5bc1-4346-ad44-f7e4101f4219 15631-0580 HUMAN OTC DRUG EUPATORIUM PURPUREUM EUPATORIUM PURPUREUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EUTROCHIUM PURPUREUM ROOT 1 [hp_X]/1 N 20181231 15631-0581_2328a22c-e57e-4cda-acb9-9d62968606c2 15631-0581 HUMAN OTC DRUG EUPHRASIA OFFICINALIS EUPHRASIA OFFICINALIS TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EUPHRASIA STRICTA 1 [hp_X]/1 N 20181231 15631-0582_d7358da8-efb0-4a61-95eb-f2d8b66d4af9 15631-0582 HUMAN OTC DRUG FEL TAURI FEL TAURI TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc BOS TAURUS BILE 1 [hp_X]/1 N 20181231 15631-0583_0b06241a-8450-448c-9144-bd0730f70016 15631-0583 HUMAN OTC DRUG FERRUM METALLICUM FERRUM METALLICUM TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc IRON 1 [hp_X]/1 N 20181231 15631-0584_841c4e42-1a1a-4d11-9805-28b326774c01 15631-0584 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERRUM PHOSPHORICUM TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROSOFERRIC PHOSPHATE 1 [hp_X]/1 N 20181231 15631-0585_4eda24f0-999b-406b-b372-befcdfa1704e 15631-0585 HUMAN OTC DRUG FERRUM PICRICUM FERRUM PICRICUM TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERRIC PICRATE 6 [hp_X]/1 N 20181231 15631-0586_25449080-d5bd-49e9-ad40-8aa8f0f59164 15631-0586 HUMAN OTC DRUG FRAXINUS AMERICANA FRAXINUS AMERICANA TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FRAXINUS AMERICANA BARK 1 [hp_X]/1 N 20181231 15631-0587_849f370f-27e6-4ee8-a8fc-5a665372a8df 15631-0587 HUMAN OTC DRUG FUCUS VESICULOSUS FUCUS VESICULOSUS TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FUCUS VESICULOSUS 1 [hp_X]/1 N 20181231 15631-0588_8e6d77a1-177e-49d0-8e50-8d77614547e4 15631-0588 HUMAN OTC DRUG GAULTHERIA PROCUMBENS GAULTHERIA PROCUMBENS TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GAULTHERIA PROCUMBENS TOP 1 [hp_X]/1 N 20181231 15631-0590_0bd0f6de-19fd-419e-8a70-c964a091309e 15631-0590 HUMAN OTC DRUG GINKGO BILOBA GINKGO BILOBA TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GINKGO 1 [hp_X]/1 N 20181231 15631-0591_af0e5103-4345-480e-809e-771148175a71 15631-0591 HUMAN OTC DRUG GLONOINUM GLONOINUM TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc NITROGLYCERIN 6 [hp_X]/1 N 20181231 15631-0592_d58d32d0-d18b-42d8-8f14-7253beaf6271 15631-0592 HUMAN OTC DRUG GNAPHALIUM POLYCEPHALUM GNAPHALIUM POLYCEPHALUM TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PSEUDOGNAPHALIUM OBTUSIFOLIUM 1 [hp_X]/1 N 20181231 15631-0593_7015fd9f-5f1e-430d-a119-9862bd19bd18 15631-0593 HUMAN OTC DRUG GOSSYPIUM HERBACEUM GOSSYPIUM HERBACEUM TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GOSSYPIUM HERBACEUM ROOT BARK 1 [hp_X]/1 N 20181231 15631-0594_5ad1469c-1532-4abe-8c69-08282efcfac4 15631-0594 HUMAN OTC DRUG GRAPHITES GRAPHITES TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GRAPHITE 1 [hp_X]/1 N 20181231 15631-0595_cf3312d5-aeda-465b-b507-2a37ca981b59 15631-0595 HUMAN OTC DRUG GUAIACUM GUAIACUM TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GUAIACUM OFFICINALE RESIN 1 [hp_X]/1 N 20181231 15631-0596_25946518-084c-48cd-a09e-3cb964ec7724 15631-0596 HUMAN OTC DRUG HAMAMELIS VIRGINIANA HAMAMELIS VIRGINIANA TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]/1 N 20181231 15631-0597_d46007ad-5840-4e06-838d-ecbcebe3d93a 15631-0597 HUMAN OTC DRUG HEPAR SULPHURIS CALCAREUM HEPAR SULPHURIS CALCAREUM TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM SULFIDE 1 [hp_X]/1 N 20181231 15631-0598_85c2834b-2ba2-4169-8f51-d82c68111545 15631-0598 HUMAN OTC DRUG HYDRANGEA ARBORESCENS HYDRANGEA ARBORESCENS TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HYDRANGEA ARBORESCENS ROOT 1 [hp_X]/1 N 20181231 15631-0599_c2082b04-46f9-4dfa-a2e5-8f71806c97b6 15631-0599 HUMAN OTC DRUG HYDRASTIS CANADENSIS HYDRASTIS CANADENSIS TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GOLDENSEAL 1 [hp_X]/1 N 20181231 15631-0600_5b0b9699-3890-45e3-9a5e-b7553eb41e87 15631-0600 HUMAN OTC DRUG HYDROCOTYLE ASIATICA HYDROCOTYLE ASIATICA TABLET ORAL 20160107 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GOLDENSEAL 1 [hp_X]/1 N 20181231 15631-0601_9057bca3-199e-40f1-ac45-3cf30cd52023 15631-0601 HUMAN OTC DRUG HYOSCYAMUS NIGER HYOSCYAMUS NIGER TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HYOSCYAMUS NIGER 3 [hp_X]/1 N 20181231 15631-0602_80441a42-e281-4e86-9f62-aadd89885d79 15631-0602 HUMAN OTC DRUG HYPERICUM PERFORATUM HYPERICUM PERFORATUM TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HYPERICUM PERFORATUM 3 [hp_X]/1 N 20181231 15631-0603_3ab6f427-fe32-4e3f-aeed-05489e6d2a8d 15631-0603 HUMAN OTC DRUG IGNATIA AMARA IGNATIA AMARA TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc STRYCHNOS IGNATII SEED 3 [hp_X]/1 N 20181231 15631-0605_aadc594c-453b-4852-b70f-a938a752245d 15631-0605 HUMAN OTC DRUG IRIS VERSICOLOR IRIS VERSICOLOR TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc IRIS VERSICOLOR ROOT 1 [hp_X]/1 N 20181231 15631-0606_a729f6bb-3c32-4253-8e4b-c5f835b88182 15631-0606 HUMAN OTC DRUG JUSTICIA ADHATODA JUSTICIA ADHATODA TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc JUSTICIA ADHATODA LEAF 1 [hp_X]/1 N 20181231 15631-0607_f2a33dce-13e7-438e-a1ed-7cddcc918a9a 15631-0607 HUMAN OTC DRUG KALI ARSENICOSUM KALI ARSENICOSUM TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM ARSENITE ANHYDROUS 6 [hp_X]/1 N 20181231 15631-0608_ca8efd19-6b01-410b-a287-541483daf064 15631-0608 HUMAN OTC DRUG KALI BICHROMICUM KALI BICHROMICUM TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM DICHROMATE 3 [hp_X]/1 N 20181231 15631-0609_c656f340-0add-4f8a-b184-d10d035ca76b 15631-0609 HUMAN OTC DRUG KALI CARBONICUM KALI CARBONICUM TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM CARBONATE 2 [hp_X]/1 N 20181231 15631-0610_4dd98180-d251-422c-8b27-1b257e19e703 15631-0610 HUMAN OTC DRUG KALI IODATUM KALI IODATUM TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM IODIDE 1 [hp_X]/1 N 20181231 15631-0611_ede9ce73-6d7f-4438-8e1e-acfec3dcf0cf 15631-0611 HUMAN OTC DRUG KALI MURIATICUM KALI MURIATICUM TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM CHLORIDE 1 [hp_X]/1 N 20181231 15631-0612_89b5adff-6622-4452-b06d-1a9c22dac30e 15631-0612 HUMAN OTC DRUG KALI PHOSPHORICUM KALI PHOSPHORICUM TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM PHOSPHATE, DIBASIC 1 [hp_X]/1 N 20181231 15631-0613_54a1388e-f4d5-4960-ba9a-956b28d0f0ad 15631-0613 HUMAN OTC DRUG KALI SULPHURICUM KALI SULPHURICUM TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM SULFATE 1 [hp_X]/1 N 20181231 15631-0615_1e087225-bccf-4295-aaaf-f9e699cb962e 15631-0615 HUMAN OTC DRUG KREOSOTUM KREOSOTUM TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc WOOD CREOSOTE 3 [hp_X]/1 N 20181231 15631-0616_1d8f664f-2f05-4053-867d-436765f4b316 15631-0616 HUMAN OTC DRUG LAC CANINUM LAC CANINUM TABLET ORAL 20151218 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CANIS LUPUS FAMILIARIS MILK 3 [hp_X]/1 N 20181231 15631-0617_9dc46f32-2206-4aa0-abc5-628adc115ff2 15631-0617 HUMAN OTC DRUG LAC DEFLORATUM LAC DEFLORATUM TABLET ORAL 20151221 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SKIM MILK 3 [hp_X]/1 N 20181231 15631-0618_1df7feb9-f828-4fba-90d1-9b25facb6978 15631-0618 HUMAN OTC DRUG LAC FELINUM LAC FELINUM TABLET ORAL 20151221 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FELIS CATUS MILK 3 [hp_X]/1 N 20181231 15631-0619_f82d451b-cca8-4ea9-862f-7f79f809f9f1 15631-0619 HUMAN OTC DRUG LAC VACCINUM LAC VACCINUM TABLET ORAL 20151224 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COW MILK 3 [hp_X]/1 N 20181231 15631-0620_e8267c6c-2ba3-4ca7-ac86-40c53202ca51 15631-0620 HUMAN OTC DRUG LACHESIS MUTUS LACHESIS MUTUS TABLET ORAL 20151224 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LACHESIS MUTA VENOM 3 [hp_X]/1 N 20181231 15631-0621_c404e545-8f62-41b1-930a-f7d2d7383712 15631-0621 HUMAN OTC DRUG LACTUCA VIROSA LACTUCA VIROSA TABLET ORAL 20151224 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LACTUCA VIROSA 3 [hp_X]/1 N 20181231 15631-0622_989d7eab-7dce-47a4-ab76-38acc748d148 15631-0622 HUMAN OTC DRUG LATHYRUS SATIVUS LATHYRUS SATIVUS TABLET ORAL 20151224 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LATHYRUS SATIVAS SEED 1 [hp_X]/1 N 20181231 15631-0623_23defedc-2e90-4c20-9119-c7a7958d01f6 15631-0623 HUMAN OTC DRUG LECITHIN LECITHIN TABLET ORAL 20151224 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EGG PHOSPHOLIPIDS 2 [hp_X]/1 N 20181231 15631-0624_9da82555-3dee-48f3-9586-eb83deb04a1c 15631-0624 HUMAN OTC DRUG LEDUM PALUSTRE LEDUM PALUSTRE TABLET ORAL 20151228 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LEDUM PALUSTRE TWIG 1 [hp_X]/1 N 20181231 15631-0625_ca5ba62d-0522-4879-8c01-8c465b05003d 15631-0625 HUMAN OTC DRUG LEMNA MINOR LEMNA MINOR TABLET ORAL 20151224 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LEMNA MINOR 1 [hp_X]/1 N 20181231 15631-0626_b09be715-8f2a-46a3-abd3-ddad079ffd0c 15631-0626 HUMAN OTC DRUG LILIUM TIGRINUM LILIUM TIGRINUM TABLET ORAL 20151225 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LILIUM LANCIFOLIUM WHOLE FLOWERING 1 [hp_X]/1 N 20181231 15631-0627_be86bec8-0999-4b79-8f3a-528da2cdec43 15631-0627 HUMAN OTC DRUG LYCOPODIUM CLAVATUM LYCOPODIUM CLAVATUM TABLET ORAL 20151225 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LYCOPODIUM CLAVATUM SPORE 1 [hp_X]/1 N 20181231 15631-0628_3f81744e-3754-465c-9aea-2b403b8ebd21 15631-0628 HUMAN OTC DRUG LYCOPUS VIRGINICUS LYCOPUS VIRGINICUS TABLET ORAL 20151225 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LYCOPUS VIRGINICUS 1 [hp_X]/1 N 20181231 15631-0629_05329aac-cda2-4796-9a6d-76ad0d38b484 15631-0629 HUMAN OTC DRUG MAGNESIA CARBONICA MAGNESIA CARBONICA TABLET ORAL 20151225 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MAGNESIUM CARBONATE 1 [hp_X]/1 N 20181231 15631-0630_c7f1f126-ffc4-4934-bd88-c3b139deefff 15631-0630 HUMAN OTC DRUG MAGNESIA PHOSPHORICA MAGNESIA PHOSPHORICA TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 1 [hp_X]/1 N 20181231 15631-0631_2a322647-663f-4204-b312-9a77f1f9d8c3 15631-0631 HUMAN OTC DRUG MAGNESIA SULPHURICA MAGNESIA SULPHURICA TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MAGNESIUM SULFATE HEPTAHYDRATE 1 [hp_X]/1 N 20181231 15631-0632_63e3a363-f56e-4c95-be00-1fd1a4d33c1b 15631-0632 HUMAN OTC DRUG MERCURIUS CORROSIVUS MERCURIUS CORROSIVUS TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MERCURIC CHLORIDE 6 [hp_X]/1 N 20181231 15631-0633_0f6c0ebd-22c0-41ee-9136-ca3c24b9df62 15631-0633 HUMAN OTC DRUG MERCURIUS IODATUS FLAVUS MERCURIUS IODATUS FLAVUS TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MERCUROUS IODIDE 6 [hp_X]/1 N 20181231 15631-0634_316df70c-c1e4-4ed9-8a11-a204886de208 15631-0634 HUMAN OTC DRUG MERCURIUS IODATUS RUBER MERCURIUS IODATUS RUBER TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MERCURIC IODIDE 6 [hp_X]/1 N 20181231 15631-0635_bebd58dd-49c8-4558-9a0c-2c8f3c1bbc3e 15631-0635 HUMAN OTC DRUG MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MERCURIUS SOLUBILIS 6 [hp_X]/1 N 20181231 15631-0636_0959143a-a377-4b6b-9cdf-832767abb022 15631-0636 HUMAN OTC DRUG MEZEREUM MEZEREUM TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DAPHNE MEZEREUM BARK 1 [hp_X]/1 N 20181231 15631-0637_812f1069-6c9f-42dd-bbf3-1f735172a3c5 15631-0637 HUMAN OTC DRUG MILLEFOLIUM MILLEFOLIUM TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ACHILLEA MILLEFOLIUM 1 [hp_X]/1 N 20181231 15631-0638_561e3182-da75-4e18-83da-6e240d0f74d4 15631-0638 HUMAN OTC DRUG NATRUM CARBONICUM NATRUM CARBONICUM TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM CARBONATE 1 [hp_X]/1 N 20181231 15631-0639_6a68c4fa-9716-4f00-a9b0-3a211ca7b4e0 15631-0639 HUMAN OTC DRUG NATRUM MURIATICUM NATRUM MURIATICUM TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM CHLORIDE 1 [hp_X]/1 N 20181231 15631-0640_82fcee02-c1c5-40b7-97f4-faf599000786 15631-0640 HUMAN OTC DRUG NATRUM PHOSPHORICUM NATRUM PHOSPHORICUM TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 1 [hp_X]/1 N 20181231 15631-0641_c462c10b-7dbf-4d84-8661-015e006e5dcf 15631-0641 HUMAN OTC DRUG NATRUM SULPHURICUM NATRUM SULPHURICUM TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM SULFATE 1 [hp_X]/1 N 20181231 15631-0642_6193fe12-7eec-4898-9072-6f7e1b97c6b8 15631-0642 HUMAN OTC DRUG NUX VOMICA NUX VOMICA TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc STRYCHNOS NUX-VOMICA SEED 3 [hp_X]/1 N 20181231 15631-0644_d8d4f03f-d7e3-4c71-82ad-5ddb9afcdae2 15631-0644 HUMAN OTC DRUG OCIMUM SANCTUM OCIMUM SANCTUM TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc OCIMUM TENUIFLORUM TOP 1 [hp_X]/1 N 20181231 15631-0645_78af4537-acee-47d6-a045-d2e99014d58f 15631-0645 HUMAN OTC DRUG OVA TOSTA OVA TOSTA TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc EGG SHELL, COOKED 1 [hp_X]/1 N 20181231 15631-0646_274ba61a-a70b-4043-9899-9c92ea467ed9 15631-0646 HUMAN OTC DRUG PAEONIA OFFICINALIS PAEONIA OFFICINALIS TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PAEONIA OFFICINALIS ROOT 1 [hp_X]/1 N 20181231 15631-0647_b0cc4aaa-bcbe-4970-85ee-b78b95cc4d02 15631-0647 HUMAN OTC DRUG PAREIRA BRAVA PAREIRA BRAVA TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CHONDRODENDRON TOMENTOSUM ROOT 1 [hp_X]/1 N 20181231 15631-0648_88b616de-61a9-46d3-9e5e-833d29398562 15631-0648 HUMAN OTC DRUG PASSIFLORA INCARNATA PASSIFLORA INCARNATA TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PASSIFLORA INCARNATA FLOWERING TOP 1 [hp_X]/1 N 20181231 15631-0649_7c9fe9f2-cce9-4c8f-94ea-391c882d693f 15631-0649 HUMAN OTC DRUG PETROLEUM PETROLEUM TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc KEROSENE 1 [hp_X]/1 N 20181231 15631-0650_084303f1-86e1-4953-99dd-0a028ed82037 15631-0650 HUMAN OTC DRUG PETROSELINUM SATIVUM PETROSELINUM SATIVUM TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PETROSELINUM CRISPUM 1 [hp_X]/1 N 20181231 15631-0651_3b689cdc-16ff-4fe6-bcdd-717f3109b4e7 15631-0651 HUMAN OTC DRUG PHOSPHORICUM ACIDUM PHOSPHORICUM ACIDUM TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PHOSPHORIC ACID 3 [hp_X]/1 N 20181231 15631-0652_d5049f67-3cc8-4c8a-b4d1-fb2dcab6f755 15631-0652 HUMAN OTC DRUG PHOSPHORUS PHOSPHORUS TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PHOSPHORUS 4 [hp_X]/1 N 20181231 15631-0653_7a653aec-e3e3-4079-b049-844e1abf0b10 15631-0653 HUMAN OTC DRUG PHYSOSTIGMA VENENOSUM PHYSOSTIGMA VENENOSUM TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PHYSOSTIGMA VENENOSUM SEED 4 [hp_X]/41 N 20181231 15631-0654_931e19d2-5cf3-47f4-80a8-27a63cc787dd 15631-0654 HUMAN OTC DRUG PHYTOLACCA DECANDRA PHYTOLACCA DECANDRA TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PHYTOLACCA AMERICANA ROOT 2 [hp_X]/21 N 20181231 15631-0655_d5fae916-1bb6-4d5b-9df6-a86699ea141c 15631-0655 HUMAN OTC DRUG PILOCARPUS PILOCARPUS TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PILOCARPUS JABORANDI LEAF 3 [hp_X]/1 N 20181231 15631-0656_2e838c42-0f35-4a1a-93fa-128cc2dd7db7 15631-0656 HUMAN OTC DRUG PLANTAGO MAJOR PLANTAGO MAJOR TABLET ORAL 20151226 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PLANTAGO MAJOR 1 [hp_X]/1 N 20181231 15631-0658_fff92d21-4818-443c-9866-cc7b59213571 15631-0658 HUMAN OTC DRUG PLUMBUM METALLICUM PLUMBUM METALLICUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LEAD 6 [hp_X]/1 N 20181231 15631-0659_2c3a7b86-9743-4c54-96b6-dd2acdcdecc0 15631-0659 HUMAN OTC DRUG PODOPHYLLUM PELTATUM PODOPHYLLUM PELTATUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PODOPHYLLUM 3 [hp_X]/1 N 20181231 15631-0660_95b3f428-70ee-47bd-a74a-70d11b034507 15631-0660 HUMAN OTC DRUG POTHOS FOETIDUS POTHOS FOETIDUS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SYMPLOCARPUS FOETIDUS ROOT 1 [hp_X]/1 N 20181231 15631-0661_238b9aec-e608-4677-b425-f36c051bcb98 15631-0661 HUMAN OTC DRUG PULSATILLA PULSATILLA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc PULSATILLA VULGARIS 1 [hp_X]/1 N 20181231 15631-0662_4068366b-a483-4336-9916-9a7d12451fd4 15631-0662 HUMAN OTC DRUG PYROGENIUM PYROGENIUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RANCID BEEF 12 [hp_X]/1 N 20181231 15631-0663_ecb9dff2-5774-4acc-b904-779ff210d47c 15631-0663 HUMAN OTC DRUG QUEBRACHO QUEBRACHO TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ASPIDOSPERMA QUEBRACHO-BLANCO BARK 1 [hp_X]/1 N 20181231 15631-0665_fde4dc5d-f178-4a9f-b463-848fc1032fb9 15631-0665 HUMAN OTC DRUG RADIUM BROMATUM RADIUM BROMATUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RADIUM BROMIDE 8 [hp_X]/1 N 20181231 15631-0666_44fdf12a-e3aa-4b37-9eea-9db0fc02e964 15631-0666 HUMAN OTC DRUG RAUWOLFIA SERPENTINA RAUWOLFIA SERPENTINA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RAUWOLFIA SERPENTINA 1 [hp_X]/61 N 20181231 15631-0667_c0708fbd-ee35-4df7-a669-28fbbf55271b 15631-0667 HUMAN OTC DRUG RHODODENDRON CHRYSANTHUM RHODODENDRON CHRYSANTHUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RHODODENDRON AUREUM LEAF 3 [hp_X]/1 N 20181231 15631-0668_720c366c-2e19-4bb0-bd0b-36a4fd798f6b 15631-0668 HUMAN OTC DRUG RHUS AROMATICA RHUS AROMATICA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RHUS AROMATICA ROOT BARK 3 [hp_X]/1 N 20181231 15631-0669_52fdc6f6-bda7-4df6-9bf5-aa0402a2c044 15631-0669 HUMAN OTC DRUG RHUS TOXICODENDRON RHUS TOXICODENDRON TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TOXICODENDRON PUBESCENS LEAF 3 [hp_X]/1 N 20181231 15631-0670_c74d1499-d5e1-44b0-b868-5f78ee78ce8d 15631-0670 HUMAN OTC DRUG RICINUS COMMUNIS RICINUS COMMUNIS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RICINUS COMMUNIS SEED 1 [hp_X]/1 N 20181231 15631-0671_8ed87a30-2232-4df0-9947-370be431d846 15631-0671 HUMAN OTC DRUG ROBINIA PSEUDOACACIA ROBINIA PSEUDOACACIA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ROBINIA PSEUDOACACIA BARK 1 [hp_X]/1 N 20181231 15631-0672_ec0bc9f2-abfb-4753-92e5-9e1fb894aef6 15631-0672 HUMAN OTC DRUG RUMEX CRISPUS RUMEX CRISPUS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RUMEX CRISPUS ROOT 1 [hp_X]/1 N 20181231 15631-0673_6b1f6abe-fa09-4811-ae8a-572e94048a39 15631-0673 HUMAN OTC DRUG RUTA GRAVEOLENS RUTA GRAVEOLENS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/1 N 20181231 15631-0674_2012f40e-8a9a-4ed3-b36a-c99b7aae29c0 15631-0674 HUMAN OTC DRUG SABADILLA SABADILLA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SCHOENOCAULON OFFICINALE SEED 1 [hp_X]/1 N 20181231 15631-0675_2c89f655-31cb-4a3d-a0c1-ea8f86be5694 15631-0675 HUMAN OTC DRUG SABAL SERRULATA SABAL SERRULATA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SAW PALMETTO 1 [hp_X]/1 N 20181231 15631-0676_101ee9ff-95d3-44a1-88e9-e488b8331e07 15631-0676 HUMAN OTC DRUG SABINA SABINA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc JUNIPERUS SABINA LEAFY TWIG 3 [hp_X]/1 N 20181231 15631-0678_1bdd22e3-e2c6-4a17-9670-0a92c0936b83 15631-0678 HUMAN OTC DRUG SALIX NIGRA SALIX NIGRA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SALIX NIGRA BARK 1 [hp_X]/1 N 20181231 15631-0679_d7d3a64d-f22d-4780-97d4-b7945e7b43c6 15631-0679 HUMAN OTC DRUG SANGUINARIA CANADENSIS SANGUINARIA CANADENSIS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SANGUINARIA CANADENSIS ROOT 1 [hp_X]/1 N 20181231 15631-0680_83c16ae2-f81a-4b5a-8a15-da605d67b9e3 15631-0680 HUMAN OTC DRUG SARSAPARILLA SARSAPARILLA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SMILAX REGELII ROOT 1 [hp_X]/1 N 20181231 15631-0681_4e3bef97-9300-4ecb-acb0-4ef46a931c43 15631-0681 HUMAN OTC DRUG SECALE CORNUTUM SECALE CORNUTUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CLAVICEPS PURPUREA SCLEROTIUM 3 [hp_X]/1 N 20181231 15631-0683_83020476-4546-4985-a9d2-d9da0851e44a 15631-0683 HUMAN OTC DRUG SENEGA OFFICINALIS SENEGA OFFICINALIS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POLYGALA SENEGA ROOT 1 [hp_X]/1 N 20181231 15631-0684_7ac310d3-4b23-4289-aa95-8a7d402859bb 15631-0684 HUMAN OTC DRUG SEPIA SEPIA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SEPIA OFFICINALIS JUICE 1 [hp_X]/1 N 20181231 15631-0685_aca3dbaa-4e39-4631-8683-64df5f9c7706 15631-0685 HUMAN OTC DRUG SILICEA SILICEA TABLET ORAL 20151207 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SILICON DIOXIDE 2 [hp_X]/1 N 20181231 15631-0687_f969305e-5ac5-477c-809b-faa87dca92cc 15631-0687 HUMAN OTC DRUG SPONGIA TOSTA SPONGIA TOSTA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SPONGIA OFFICINALIS SKELETON, ROASTED 1 [hp_X]/1 N 20181231 15631-0688_13da4986-4f12-4124-8104-9314a171cb87 15631-0688 HUMAN OTC DRUG STANNUM METALLICUM STANNUM METALLICUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TIN 3 [hp_X]/1 N 20181231 15631-0689_a29d41ae-977c-4fea-b162-79c1d4329fed 15631-0689 HUMAN OTC DRUG STAPHYSAGRIA STAPHYSAGRIA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DELPHINIUM STAPHISAGRIA SEED 3 [hp_X]/1 N 20181231 15631-0690_34e6d4e9-f8f7-497f-adba-7a252056ffae 15631-0690 HUMAN OTC DRUG STICTA PULMONARIA STICTA PULMONARIA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LOBARIA PULMONARIA 1 [hp_X]/1 N 20181231 15631-0691_a67885c3-4f68-496c-940d-f5759cdee394 15631-0691 HUMAN OTC DRUG STRAMONIUM STRAMONIUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc DATURA STRAMONIUM 6 [hp_X]/1 N 20181231 15631-0692_6de71700-bc3d-4889-be61-fa15d57d8232 15631-0692 HUMAN OTC DRUG SULPHUR SULPHUR TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SULFUR 1 [hp_X]/1 N 20181231 15631-0693_ffe2a74c-bb6c-41b3-9062-395573fa2245 15631-0693 HUMAN OTC DRUG SYMPHYTUM OFFICINALE SYMPHYTUM OFFICINALE TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc COMFREY ROOT 1 [hp_X]/1 N 20181231 15631-0694_0aaf385c-17ef-40c4-a3a7-7420a6aa913a 15631-0694 HUMAN OTC DRUG SYZYGIUM JAMBOLANUM SYZYGIUM JAMBOLANUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SYZYGIUM CUMINI SEED 3 [hp_X]/1 N 20181231 15631-0695_c8053ba5-3348-49fe-b9af-d0a1c51ae823 15631-0695 HUMAN OTC DRUG TARENTULA HISPANA TARENTULA HISPANA TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LYCOSA TARANTULA 8 [hp_X]/1 N 20181231 15631-0696_5db4a9c6-7117-480f-ba96-133ac2d34a36 15631-0696 HUMAN OTC DRUG TELLURIUM METALLICUM TELLURIUM METALLICUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TELLURIUM 3 [hp_X]/1 N 20181231 15631-0697_a9560928-321a-4cf9-a5b0-f8d9736a3821 15631-0697 HUMAN OTC DRUG TEUCRIUM MARUM TEUCRIUM MARUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TEUCRIUM MARUM 1 [hp_X]/1 N 20181231 15631-0698_e22a9c2d-bf6d-43b2-85a8-33c6d1aa7fe6 15631-0698 HUMAN OTC DRUG THIOSINAMINUM THIOSINAMINUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALLYLTHIOUREA 3 [hp_X]/1 N 20181231 15631-0699_b1f33736-10a5-4bb4-a3e7-40b59bcdf917 15631-0699 HUMAN OTC DRUG THUJA OCCIDENTALIS THUJA OCCIDENTALIS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc THUJA OCCIDENTALIS LEAFY TWIG 1 [hp_X]/1 N 20181231 15631-0700_0958841b-8d8d-45c8-a6ad-540b59760ab6 15631-0700 HUMAN OTC DRUG URANIUM NITRICUM URANIUM NITRICUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc URANYL NITRATE HEXAHYDRATE 8 [hp_X]/1 N 20181231 15631-0701_056cf141-fbc5-45bb-9aba-e3c3e5b1bf80 15631-0701 HUMAN OTC DRUG URTICA URENS URTICA URENS TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc URTICA URENS 1 [hp_X]/1 N 20181231 15631-0702_c1347650-44d6-40ff-87ce-63a326326c6b 15631-0702 HUMAN OTC DRUG UVA URSI UVA URSI TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARCTOSTAPHYLOS UVA-URSI LEAF 1 [hp_X]/1 N 20181231 15631-0703_7036f4a3-8785-4884-9d61-c8d4dc82afd7 15631-0703 HUMAN OTC DRUG VERATRUM ALBUM VERATRUM ALBUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VERATRUM ALBUM ROOT 3 [hp_X]/1 N 20181231 15631-0704_f80936cb-d023-4bce-9cd8-fdd65445bd13 15631-0704 HUMAN OTC DRUG VINCA MINOR VINCA MINOR TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VINCA MINOR 3 [hp_X]/1 N 20181231 15631-0705_3538b9e7-9683-48ea-baca-303aaceed9ce 15631-0705 HUMAN OTC DRUG VISCUM ALBUM VISCUM ALBUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc VISCUM ALBUM FRUITING TOP 3 [hp_X]/1 N 20181231 15631-0706_4d72af58-d6aa-4ac8-9aba-812ae9c23562 15631-0706 HUMAN OTC DRUG YOHIMBINUM YOHIMBINUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc YOHIMBINE 1 [hp_X]/1 N 20181231 15631-0707_5bf27846-9bcc-4dac-8483-926f7c9c11d2 15631-0707 HUMAN OTC DRUG ZINCUM METALLICUM ZINCUM METALLICUM TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ZINC 3 [hp_X]/1 N 20181231 15631-0708_d7e2d456-5421-460d-bb04-1f655323b0f3 15631-0708 HUMAN OTC DRUG ZINGIBER OFFICINALE ZINGIBER OFFICINALE TABLET ORAL 20151227 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GINGER 1 [hp_X]/1 N 20181231 15631-2301_23743f7b-3e1e-401d-8766-fa0f14bbd8fb 15631-2301 HUMAN OTC DRUG ABROTANUM ABROTANUM GEL TOPICAL 20160322 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARTEMISIA ABROTANUM FLOWERING TOP 1 [hp_Q]/g N 20181231 15631-2303_cc34242a-7a00-459d-8150-b9c256f8950a 15631-2303 HUMAN OTC DRUG AESCULUS HIP AESCULUS HIP GEL TOPICAL 20160322 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HORSE CHESTNUT 1 [hp_X]/g N 20181231 15631-2304_aab2b3b1-6d3c-4e0c-8faf-df83402bb6da 15631-2304 HUMAN OTC DRUG APIS MEL APIS MEL GEL TOPICAL 20160322 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc APIS MELLIFERA 1 [hp_X]/g N 20181231 15631-2305_d971cd8b-cbf7-47da-8668-d4bb371316db 15631-2305 HUMAN OTC DRUG ARNICA ARNICA GEL TOPICAL 20160330 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARNICA MONTANA 1 [hp_X]/g N 20181231 15631-2307_9f9035b3-4caa-4845-81f3-df8f38306cfd 15631-2307 HUMAN OTC DRUG BELLADONNA BELLADONNA GEL TOPICAL 20160330 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ATROPA BELLADONNA 1 [hp_X]/g N 20181231 15631-2308_197342e9-995f-4fd0-a83d-6e4d137c496b 15631-2308 HUMAN OTC DRUG BERBERIS AQUARIUS BERBERIS AQUARIUS GEL TOPICAL 20160519 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc MAHONIA AQUIFOLIUM ROOT BARK 1 [hp_X]/g N 20181231 15631-2309_8b8af820-4d62-4113-bba1-b6816c7d748d 15631-2309 HUMAN OTC DRUG CALCAREA FLOUR CALCAREA FLOUR GEL TOPICAL 20160330 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM FLUORIDE 3 [hp_X]/g N 20181231 15631-2310_de14d02e-c722-4a9a-830c-77627de7bc77 15631-2310 HUMAN OTC DRUG CALENDULA OFF CALENDULA OFF GEL TOPICAL 20160330 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g N 20181231 15631-2311_5acc8005-3454-43bd-b551-4326dbccaba2 15631-2311 HUMAN OTC DRUG CANTHARIS CANTHARIS GEL TOPICAL 20160330 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc LYTTA VESICATORIA 3 [hp_X]/g N 20181231 15631-2312_64fa99f0-876b-4f03-b673-734aebeef0eb 15631-2312 HUMAN OTC DRUG CONIUM CONIUM GEL TOPICAL 20160330 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CONIUM MACULATUM FLOWERING TOP 6 [hp_X]/g N 20181231 15631-2314_43606f52-e869-4a80-aae9-0a38b055d446 15631-2314 HUMAN OTC DRUG FERRUM PHOS FERRUM PHOS GEL TOPICAL 20160330 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROSOFERRIC PHOSPHATE 1 [hp_X]/g N 20181231 15631-2315_26879fd2-40ca-43c2-bca1-acd50281fc38 15631-2315 HUMAN OTC DRUG GRAPHITES GRAPHITES GEL TOPICAL 20160330 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc GRAPHITE 1 [hp_X]/g N 20181231 15631-2316_2b0f07a0-da79-4ece-9bac-fb99fb814a28 15631-2316 HUMAN OTC DRUG HAMAMELIS HAMAMELIS GEL TOPICAL 20160330 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]/g N 20181231 15631-2317_bb24818f-5bad-4d1c-a0b3-cd81415ca4e1 15631-2317 HUMAN OTC DRUG HYPERICUM HYPERICUM GEL TOPICAL 20160426 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc HYPERICUM PERFORATUM 1 [hp_X]/g N 20181231 15631-2318_578b62f3-34ea-457c-b867-59b2f10f3616 15631-2318 HUMAN OTC DRUG PETROLEUM PETROLEUM GEL TOPICAL 20160426 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc KEROSENE 1 [hp_X]/g N 20181231 15631-2319_aff3d400-ef19-4010-bcea-ea4a56b68dbf 15631-2319 HUMAN OTC DRUG RHUS TOX RHUS TOX GEL TOPICAL 20160426 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TOXICODENDRON PUBESCENS LEAF 3 [hp_X]/g N 20181231 15631-2320_a070c051-af1a-4805-8828-f81134e035db 15631-2320 HUMAN OTC DRUG RUTA GRAV RUTA GRAV GEL TOPICAL 20160426 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc RUTA GRAVEOLENS FLOWERING TOP 1 [hp_X]/g N 20181231 15631-2321_87d585b4-b134-4776-b3f4-66a402722486 15631-2321 HUMAN OTC DRUG SILICEA SILICEA GEL TOPICAL 20160426 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SILICON DIOXIDE 1 [hp_X]/g N 20181231 15631-2322_fa4fe270-9cdf-435c-a611-5cf511a5be4f 15631-2322 HUMAN OTC DRUG SULPHUR SULPHUR GEL TOPICAL 20160426 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SULFUR 1 [hp_X]/g N 20181231 15631-2323_ec82d74b-5779-404b-93f9-a61d4546383a 15631-2323 HUMAN OTC DRUG THIOSINAMINUM THIOSINAMINUM GEL TOPICAL 20160426 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ALLYLTHIOUREA 1 [hp_X]/g N 20181231 15631-2324_c5f8acac-8592-4af1-bc58-d74fa3c5c0bd 15631-2324 HUMAN OTC DRUG THUJA OCC THUJA OCC GEL TOPICAL 20160426 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc THUJA OCCIDENTALIS LEAFY TWIG 1 [hp_X]/g N 20181231 15631-2325_d9824b1f-3586-426c-9f02-dda23e067d91 15631-2325 HUMAN OTC DRUG URTICA URENS URTICA URENS GEL TOPICAL 20160426 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc URTICA URENS 1 [hp_X]/g N 20181231 15631-2351_8a640f50-ad4c-4c9f-8cfc-5fc23fafb1fc 15631-2351 HUMAN OTC DRUG Five Phos CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE 3; 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2352_b7a553cb-8815-40a9-8ca3-86ef55efc995 15631-2352 HUMAN OTC DRUG Five Phos CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2353_c827c6ed-f25f-41c8-8127-ac6894c91cae 15631-2353 HUMAN OTC DRUG Five Phos CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2354_3b94f7c9-7a6a-40f6-b400-06ba1791ae34 15631-2354 HUMAN OTC DRUG Five Phos CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2356_aa044b80-175a-4993-9985-fa2dbdf8c191 15631-2356 HUMAN OTC DRUG Bio-Combination 1 CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, KALI PHOSPHORICUM TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC 3; 12; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2357_1dd5ee94-096b-438d-871a-b915b75790f1 15631-2357 HUMAN OTC DRUG Bio-Combination 2 KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM SULPHURICUM TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM SULFATE 3; 6; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2358_aeea0304-d0e9-4695-a06d-4446071cfe36 15631-2358 HUMAN OTC DRUG Bio-Combination 3 CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM SULPHURICUM TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM SULFATE 3; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2359_e5ea271c-fadd-490a-b59c-7f450e336996 15631-2359 HUMAN OTC DRUG Bio-Combination 4 CALCAREA FLUORICA, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM FLUORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SILICON DIOXIDE 3; 3; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2360_99b8bea7-840d-4836-901c-220793f9d962 15631-2360 HUMAN OTC DRUG Bio-Combination 5 FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI SULPHURICUM, NATRUM MURIATICUM TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM CHLORIDE 12; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2361_d8cadba5-2021-4c62-a5c1-c551a432539a 15631-2361 HUMAN OTC DRUG Bio-Combination 6 FERRUM PHOSPHORICUM, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM SULPHURICUM TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM SULFATE 12; 3; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2362_477732d9-08f2-403d-ae10-8b3becd3de45 15631-2362 HUMAN OTC DRUG Bio-Combination 7 CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE 3; 12; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2363_61c99452-5e78-4d44-a6d5-10e1d8d5960a 15631-2363 HUMAN OTC DRUG Bio-Combination 8 CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SODIUM SULFATE 3; 3; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2364_c9a18bb6-4d3e-4d4e-b1b7-d34ceff589f0 15631-2364 HUMAN OTC DRUG Bio-Combination 9 FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12; 6; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2365_307d7918-889f-4f70-ac35-2ba29b03851f 15631-2365 HUMAN OTC DRUG Bio-Combination 10 CALCAREA FLUORICA, CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, KALI MURIATICUM,SILICEA TABLET ORAL 20160318 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; SILICON DIOXIDE 3; 3; 12; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2366_4035c72d-4c22-45ea-b9d6-6c9285f3419f 15631-2366 HUMAN OTC DRUG Bio-Combination 11 FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM SULFATE 12; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2367_36dea673-c024-40a7-a4f8-3bbdfd2f78da 15631-2367 HUMAN OTC DRUG Bio-Combination 12 FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE 12; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2368_1a5fc90b-cde2-4ec1-bf58-68b29d7a8cb7 15631-2368 HUMAN OTC DRUG Bio-Combination 13 CALCAREA PHOSPHORICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM TABLET ORAL 20160326 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SODIUM CHLORIDE 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2369_788d2337-5516-47af-88b1-1fd7ae0093a8 15631-2369 HUMAN OTC DRUG Bio-Combination 14 FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI SULPHURICUM TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM SULFATE 12; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2370_f16995f6-f949-4dc4-a597-e40f29208965 15631-2370 HUMAN OTC DRUG Bio-Combination 15 CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM,KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 3; 12; 6; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2372_5b6d5312-8b28-48d1-9330-48ee84a499dc 15631-2372 HUMAN OTC DRUG Bio-Combination 17 CALCAREA FLUORICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC 6; 3; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2373_4d26e4b9-66c9-4152-828c-87c16c1e9487 15631-2373 HUMAN OTC DRUG Bio-Combination 18 CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, SILICEA TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; SILICON DIOXIDE 6; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2374_55049501-e8b7-41f3-9b0d-b98246b6c6c5 15631-2374 HUMAN OTC DRUG Bio-Combination 19 FERRUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, SILICEA TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc FERROSOFERRIC PHOSPHATE; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE 12; 3; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2375_8d7a69f4-5a33-4546-9da1-fb10e50ee2c6 15631-2375 HUMAN OTC DRUG Bio-Combination 20 CALCAREA FLUORICA, CALCAREA SULPHURICA, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM CHLORIDE; SODIUM SULFATE 3; 3; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2376_07c79d5e-5065-46f3-a1c4-c6504404aa93 15631-2376 HUMAN OTC DRUG Bio-Combination 21 CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, NATRUM MURIATICUM TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE 3; 12; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2377_8e8fa99c-2592-4bf2-b21c-b0234cc98897 15631-2377 HUMAN OTC DRUG Bio-Combination 22 CALCAREA PHOSPHORICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, SILICEA TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; SILICON DIOXIDE 6; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2378_062252a3-c8a3-4424-bac7-c0ce4d6da532 15631-2378 HUMAN OTC DRUG Bio-Combination 23 CALCAREA FLUORICA, FERRUM PHOSPHORICUM, MAGNESIA PHOSPHORICA TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2379_72588a3f-947d-4990-a396-e40b04b7108e 15631-2379 HUMAN OTC DRUG Bio-Combination 24 CALCAREA FLUORICA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM,MAGNESIA PHOSPHORICA,NATRUM PHOSPHORICUM TABLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3; 3; 3; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2380_f4a2d4e6-a0f9-4163-b8fe-3782fcf052f1 15631-2380 HUMAN OTC DRUG Bio-Combination 25 NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SILICON DIOXIDE 3; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2381_fe3ccf97-0b67-4867-b576-b260b39627f9 15631-2381 HUMAN OTC DRUG Bio-Combination 26 CALCAREA FLUORICA, CALCAREA PHOSPHORICA, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA TABLET ORAL 20160324 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2382_65aaced0-c425-4aff-9ce2-c71efcd58a03 15631-2382 HUMAN OTC DRUG Bio-Combination 27 CALCAREA PHOSPHORICA, KALI PHOSPHORICUM, NATRUM MURIATICUM TABLET ORAL 20160411 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc TRIBASIC CALCIUM PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2383_82d460a0-71c8-4b47-822f-7167cdcb2f69 15631-2383 HUMAN OTC DRUG Bio-Combination 28 CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM,KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA TABLET ORAL 20160404 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. Rxhomeo, Inc CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM SULFATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 15631-2451_0be51b2a-0116-418a-a529-8966aacfca71 15631-2451 HUMAN OTC DRUG Rxhomeo Homeopathic Family Kit Rxhomeo Homeopathic Family Kit KIT ORAL 20160601 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2452_f1593464-c998-4ef1-8483-5066d497d41a 15631-2452 HUMAN OTC DRUG Rxhomeo Homeopathic Childrens Kit Rxhomeo Homeopathic Childrens Kit KIT ORAL 20160601 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2453_2614eede-a60b-4a6e-90e7-87f51a30b271 15631-2453 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 3 Rxhomeo Homeopathic Combo 3 KIT ORAL 20161021 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2454_c6dd2790-d727-410a-ba79-f86952e15da4 15631-2454 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 4 Rxhomeo Homeopathic Combo 4 KIT ORAL 20161024 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2457_4ec84e86-b065-4c8c-9b22-225da52dde98 15631-2457 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 7 Rxhomeo Homeopathic Combo 7 KIT ORAL 20161022 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2458_e9cb36e1-f36c-49de-acd1-b4c88af94dde 15631-2458 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 8 Rxhomeo Homeopathic Combo 8 KIT ORAL 20161022 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2459_d2735b8a-3848-4db6-9a0d-6d350a6f91ad 15631-2459 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 9 Rxhomeo Homeopathic Combo 9 KIT ORAL 20161022 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2460_b0f7a9fa-5143-42ff-90a1-4871b95e40a6 15631-2460 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 10 Rxhomeo Homeopathic Combo 10 KIT ORAL 20161022 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2461_e5126233-931c-4416-928b-c3c40c53bc7a 15631-2461 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 11 Rxhomeo Homeopathic Combo 11 KIT ORAL 20161022 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2462_d2702a63-dd54-452e-a873-7a9393aa16ae 15631-2462 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 12 Rxhomeo Homeopathic Combo 12 KIT ORAL 20161022 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2463_bd5f03c3-6816-4974-8970-91412e62624c 15631-2463 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 13 Rxhomeo Homeopathic Combo 13 KIT ORAL 20161022 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2464_fd657d73-db05-47a9-b0ba-ac36faa40d1d 15631-2464 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 14 Rxhomeo Homeopathic Combo 14 KIT ORAL 20161022 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2466_2be406d3-7442-4096-bfa8-88d077711a58 15631-2466 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 16 Rxhomeo Homeopathic Combo 16 KIT ORAL 20161023 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2467_7ec3a104-0a9c-4a4b-bcd6-c11bd98eec66 15631-2467 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 17 Rxhomeo Homeopathic Combo 17 KIT ORAL 20161023 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2468_27832dfa-4c3a-47a7-aea0-d64bb39a925e 15631-2468 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 18 Rxhomeo Homeopathic Combo 18 KIT ORAL 20161024 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2469_a2dc4db0-9222-4f1e-9799-a1483bdb8426 15631-2469 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 19 Rxhomeo Homeopathic Combo 19 KIT ORAL 20161024 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2470_7f91e175-b2a0-4fad-b66c-ca5db65a951e 15631-2470 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 20 Rxhomeo Homeopathic Combo 20 KIT ORAL 20161024 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2471_4c6901c2-0645-419a-aaf6-b21bc06d4821 15631-2471 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 21 Rxhomeo Homeopathic Combo 21 KIT ORAL 20161024 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2472_8f7483aa-d431-4288-85ed-bba61dea899e 15631-2472 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 22 Rxhomeo Homeopathic Combo 22 KIT ORAL 20161024 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2473_493075be-6638-43df-8029-c63f5be8a0a3 15631-2473 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 23 Rxhomeo Homeopathic Combo 23 KIT ORAL 20161024 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2474_0259443b-00bd-4c7b-9d2d-e3d6706a68dc 15631-2474 HUMAN OTC DRUG Rxhomeo Homeopathic Combo 24 Rxhomeo Homeopathic Combo 24 KIT ORAL 20161024 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2478_7c703933-de7b-419d-ba26-dea77b9dcd02 15631-2478 HUMAN OTC DRUG Rxhomeo Homeopathic Combo Rxhomeo Homeopathic Combo KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2479_7390285c-165e-4f1f-b853-cfcb86b8a6ae 15631-2479 HUMAN OTC DRUG Rxhomeo Homeopathic Combo Rxhomeo Homeopathic Combo KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2482_be1d9f07-03b4-4a13-86fb-cffca4ca4da0 15631-2482 HUMAN OTC DRUG Rxhomeo Homeopathic Combo-32 Rxhomeo Homeopathic Combo-32 KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2483_239a2843-dc01-4048-993d-2bd29ddd4180 15631-2483 HUMAN OTC DRUG Rxhomeo Homeopathic Combo Rxhomeo Homeopathic Combo KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2484_10266a3f-3a2c-45be-b967-f718733a45a7 15631-2484 HUMAN OTC DRUG Rxhomeo Homeopathic Combo-34 Rxhomeo Homeopathic Combo-34 KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2485_8da4c93b-5b85-4fcf-bd79-cb1914e04659 15631-2485 HUMAN OTC DRUG Rxhomeo Homeopathic Combo-35 Rxhomeo Homeopathic Combo-35 KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2486_9ae43088-d174-4a1a-a3f0-00930363f898 15631-2486 HUMAN OTC DRUG Rxhomeo Homeopathic Combo-36 Rxhomeo Homeopathic Combo-36 KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2489_547047c6-d4db-4da5-b532-84d065e38095 15631-2489 HUMAN OTC DRUG Rxhomeo Homeopathic Combo-39 Rxhomeo Homeopathic Combo-39 KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2490_0c20bc25-3de2-4b24-bc29-d3c99113a881 15631-2490 HUMAN OTC DRUG Rxhomeo Homeopathic Combo-40 Rxhomeo Homeopathic Combo-40 KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2491_a87a33a7-09b9-4a58-8678-a9ff2bea6567 15631-2491 HUMAN OTC DRUG Rxhomeo Homeopathic Combo-41 Rxhomeo Homeopathic Combo-41 KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2493_01453f60-e379-4175-a563-7d96bbcdced1 15631-2493 HUMAN OTC DRUG Rxhomeo Homeopathic Combo Rxhomeo Homeopathic Combo KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2494_4aae779f-5054-4377-abfc-46ee99173301 15631-2494 HUMAN OTC DRUG Rxhomeo Homeopathic Combo Rxhomeo Homeopathic Combo KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2495_78f5695c-ed41-4ed0-a1a7-ab989a5247d7 15631-2495 HUMAN OTC DRUG Rxhomeo Homeopathic Combo-45 Rxhomeo Homeopathic Combo-45 KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2496_b395f928-5d15-4bf4-ac02-d8a1a688ddc9 15631-2496 HUMAN OTC DRUG Rxhomeo Homeopathic Combo-46 Rxhomeo Homeopathic Combo-46 KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15631-2498_f40ec347-443c-437a-a246-ebe06e5f6d0a 15631-2498 HUMAN OTC DRUG Rxhomeo Homeopathic Combo-48 Rxhomeo Homeopathic Combo-48 KIT ORAL 20161010 UNAPPROVED HOMEOPATHIC Rxhomeo Private Limited d.b.a. N 20181231 15667-5049_a5157e03-c82f-4ce9-9355-6b1e5c078fe4 15667-5049 HUMAN OTC DRUG PAIN GOODBYE MEDICATED CREAM MENTHOL 5% CREAM TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part348 Austin Biotechnology Inc MENTHOL 14 g/280g E 20171231 15667-7396_8c3ae600-4511-4868-a9bd-848f707e7f87 15667-7396 HUMAN OTC DRUG PAIN GOODBYE AQUEOUS PATCH METHYL SALICYLATE PATCH TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part348 Austin Biotechnology Inc METHYL SALICYLATE; 2-(L-MENTHOXY)ETHANOL 50; 80 mg/1000mg; mg/1000mg E 20171231 15687-001_818f61cc-a987-4c3f-b82d-c570cf5e0bba 15687-001 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20050905 NDA NDA205766 Big Branch Breeders Service NITROGEN 990 mL/L N 20181231 15749-801_da2a32ef-7ed4-4a3f-8e0d-326c91b191c6 15749-801 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110615 ANDA ANDA062713 American Antibiotics, Inc CEPHALEXIN 250 mg/1 E 20171231 15749-802_da2a32ef-7ed4-4a3f-8e0d-326c91b191c6 15749-802 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110615 ANDA ANDA062713 American Antibiotics, Inc CEPHALEXIN 500 mg/1 E 20171231 15749-820_60804b94-50f2-44c4-a6bf-871cab5af2f1 15749-820 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20110701 ANDA ANDA062058 American Antibiotics,Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 15749-825_60804b94-50f2-44c4-a6bf-871cab5af2f1 15749-825 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20110701 ANDA ANDA062058 American Antibiotics,Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 15751-0252_63761d78-ca63-512d-e053-2991aa0ae030 15751-0252 HUMAN OTC DRUG Tomato Day Broad Spectrum SPF 16 Sunscreen ZINC OXIDE CREAM TOPICAL 20120318 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care ZINC OXIDE 12 g/100mL N 20191231 15751-1321_61825b2e-895b-6dc3-e053-2a91aa0a1537 15751-1321 HUMAN OTC DRUG Rosehip and Lemongrass Lip SPF 15 ZINC OXIDE STICK TOPICAL 20160427 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care ZINC OXIDE 35 mg/g N 20181231 15751-2222_6182580e-3c4c-1eae-e053-2a91aa0af7f4 15751-2222 HUMAN OTC DRUG Tropical Vanilla Body Sunscreen Broad Spectrum SPF 32 OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120323 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 60; 50 mg/mL; mg/mL N 20181231 15751-2223_643da847-c17e-5e24-e053-2a91aa0ad86f 15751-2223 HUMAN OTC DRUG Tropical Vanilla Sunscreen Broad Spectrum SPF 32 OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120307 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 60; 50 mg/mL; mg/mL N 20191231 15751-2235_643d9208-f037-15da-e053-2a91aa0ac100 15751-2235 HUMAN OTC DRUG Caramel Latte Tinted Moisturizer Broad Spectrum SPF 25 Sunscreen Light To Medium OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120317 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20191231 15751-2236_643d8398-6867-0f90-e053-2a91aa0af1ee 15751-2236 HUMAN OTC DRUG Cocoa Latte Tinted Moisturizer Broad Spectrum SPF 25 Sunscreen Medium To Dark OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120317 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 6; 6 g/100mL; g/100mL N 20191231 15751-2248_643dccb7-c086-67bb-e053-2a91aa0a84c7 15751-2248 HUMAN OTC DRUG Persimmon and Cantaloupe Day Sunscreen Broad Spectrum SPF 32 Oily to Normal OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120323 OTC MONOGRAPH FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 60; 45 mg/mL; mg/mL N 20191231 15751-2259_643d8398-6857-0f90-e053-2a91aa0af1ee 15751-2259 HUMAN OTC DRUG Vanilla Latte Tinted Moisturizer Broad Spectrum SPF 25 Sunscreen Light OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120318 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20191231 15751-2272_618278d5-a428-56e5-e053-2a91aa0aa9f0 15751-2272 HUMAN OTC DRUG EMINENCE Bright Skin Moisturizer BROAD SPECTRUM SPF 30 SUNSCREEN OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120726 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 6; 4.5 g/100g; g/100g N 20181231 15751-2286_6182637d-51e4-7625-e053-2991aa0af682 15751-2286 HUMAN OTC DRUG EMINENCE Red Currant Protective Moisturizer OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20130822 OTC MONOGRAPH NOT FINAL part352 Eminence Organic Skin Care OCTINOXATE; ZINC OXIDE 60; 45 mg/mL; mg/mL N 20181231 15821-101_4d5a3f8a-3826-481e-b928-ff32deb2b593 15821-101 HUMAN OTC DRUG FreshKote Lubricant Eye Drops Povidone/Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20060401 OTC MONOGRAPH FINAL part349 FOCUS Laboratories, Inc. POVIDONE K29/32; POLYVINYL ALCOHOL 20; 27 g/1000mL; g/1000mL N 20181231 15828-206_b70a899e-87d2-4c1e-8872-f5ad189c3f58 15828-206 HUMAN OTC DRUG Zermat Xtreme Roll-On Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20121018 OTC MONOGRAPH FINAL part350 Zermat Internacional S.A. de C.V. ALUMINUM CHLOROHYDRATE 8 g/100g N 20181231 15828-207_6c1f1cd7-ee33-47e2-a05a-2d7603cf7fca 15828-207 HUMAN OTC DRUG Zermat Xtreme Roll-On Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130316 OTC MONOGRAPH FINAL part350 Zermat Internacional S.A. de C.V. ALUMINUM CHLOROHYDRATE 10 g/100g N 20181231 15828-211_6156acdb-897f-072c-e053-2991aa0a4c87 15828-211 HUMAN OTC DRUG eau d amour Antiperspirant Deodorant Roll On for Women ALUMINUM CHLOROHYDRATE CREAM TOPICAL 20160720 20180228 OTC MONOGRAPH FINAL part350 Zermat Internacional S.A. de C.V. ALUMINUM CHLOROHYDRATE 200 mg/g N 20181231 15828-212_3b3a9242-eceb-6664-e054-00144ff8d46c 15828-212 HUMAN OTC DRUG PRECIOUS ANTIPERSPIRANT DEODORANT ROLL ON FOR WOMEN Aluminum Chlorohydrate EMULSION TOPICAL 20160829 OTC MONOGRAPH FINAL part350 Zermat Internacional S.A. de C.V. ALUMINUM CHLOROHYDRATE 200 mg/g N 20181231 15828-213_61574704-d529-8b85-e053-2991aa0aa535 15828-213 HUMAN OTC DRUG AMBICIOUS ANTIPERSPIRANT DEODORANT ROLL ON FOR WOMEN Aluminum Chlorohydrate EMULSION TOPICAL 20160829 20180228 OTC MONOGRAPH FINAL part350 Zermat Internacional S.A. de C.V. ALUMINUM CHLOROHYDRATE 200 mg/g N 20181231 15828-735_4830f52a-e9e3-6a41-e054-00144ff88e88 15828-735 HUMAN OTC DRUG Zermat Skin Platinum Series Cellular Beauty Caviar and Collagen Day SPF 30 OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20160405 OTC MONOGRAPH NOT FINAL part352 Zermat Internacional S.A. de C.V. OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 30; 35 mg/g; mg/g; mg/g N 20181231 15828-737_4830e546-7dcc-3fb5-e054-00144ff8d46c 15828-737 HUMAN OTC DRUG Zermat Skin SPF 50 Broad Spectrum AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20160415 OTC MONOGRAPH NOT FINAL part352 Zermat Internacional S.A. de C.V. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 30; 100; 75; 50 mg/g; mg/g; mg/g; mg/g N 20181231 15828-870_011cb421-2bf3-415e-8a6e-54709b57826b 15828-870 HUMAN OTC DRUG zermat Antiperspirant Deodorant Roll-on for Men ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20131212 OTC MONOGRAPH FINAL part350 Zermat Internacional S.A. de C.V. ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 15828-871_2926a557-724d-4ae2-848f-785ab3fbce3f 15828-871 HUMAN OTC DRUG zermat Antiperspirant Deodorant Roll-on for Women ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20131212 OTC MONOGRAPH FINAL part350 Zermat Internacional S.A. de C.V. ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 15828-880_8bee5c78-d1ca-4c91-904c-246ea4b9b4c3 15828-880 HUMAN OTC DRUG zermat Kiwi ANTIPERSPIRANT DEODORANT ROLL-ON SENSITIVE SKIN Aluminum chlorohydrate LIQUID TOPICAL 20131002 OTC MONOGRAPH FINAL part350 Zermat Internacional ALUMINUM CHLOROHYDRATE 10 g/100g N 20181231 15828-881_2357030f-affb-4a48-9e28-114bec1348cf 15828-881 HUMAN OTC DRUG Zermat Kiwi with Fragrance Aluminum chlorohydrate LIQUID TOPICAL 20131002 OTC MONOGRAPH FINAL part350 Zermat Internacional ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 15955-327_774a39b1-452c-4346-a77e-278f3b0b0db4 15955-327 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM SOLUTION ORAL 20120430 ANDA ANDA203067 Orit Laboratories LLC LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 16047-0020_6d8aeb84-88d4-40e7-827f-718bb8f2c611 16047-0020 HUMAN OTC DRUG Repaskids Facial / Body Broad Spectrum SPF30 ZINC OXIDE, TITANIUM DIOXIDE GEL TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part352 Sesderma USA LLC ZINC OXIDE; TITANIUM DIOXIDE 125; 66 mg/mL; mg/mL N 20181231 16047-0021_49631d4e-9626-4222-9e07-e5df60a97fae 16047-0021 HUMAN OTC DRUG Repaskids Facial / Body Broad Spectrum SPF50 ZINC OXIDE, TITANIUM DIOXIDE GEL TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part352 Sesderma USA LLC ZINC OXIDE; TITANIUM DIOXIDE 170; 111 mg/mL; mg/mL N 20181231 16047-0022_dc9ac18b-6690-4234-a983-459eb0afb0db 16047-0022 HUMAN OTC DRUG Screenses Color Sunscreen Broad Spectrum SPF50 Light OCTINOXATE, TITANIUM DIOXIDE GEL TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part352 Sesderma USA LLC OCTINOXATE; TITANIUM DIOXIDE 75; 74.13 mg/g; mg/g N 20181231 16047-0023_1c0773e9-558b-41c2-8e55-7b87897807a2 16047-0023 HUMAN OTC DRUG REPASKIN FACIAL SUNSCREEN BROAD-SPECTRUM SPF 30 50ml OCTOCRYLENE, OXYBENZONE, OCTISALATE, OCTINOXATE, AVOBENZONE GEL TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part352 Sesderma USA LLC OCTOCRYLENE; OXYBENZONE; OCTISALATE; OCTINOXATE; AVOBENZONE 40; 30; 30; 30; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 16047-0024_6192a647-9fe6-45b9-8ee4-595559acff82 16047-0024 HUMAN OTC DRUG REPASKIN FACIAL SUNSCREEN BROAD-SPECTRUM SPF 50 50ml OCTOCRYLENE, TITANIUM DIOXIDE GEL TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part352 Sesderma USA LLC OCTOCRYLENE; TITANIUM DIOXIDE 70; 20 mg/mL; mg/mL N 20181231 16047-0025_916f4bef-1747-49a8-acfc-8538a1692a30 16047-0025 HUMAN OTC DRUG REPASKIN BODY BROAD-SPECTRUM SPF 30 OCTOCRYLENE, PHENYLBENZIMIDAZOLE SULFONIC ACID GEL TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part352 Sesderma USA LLC OCTOCRYLENE; ENSULIZOLE 50; 20 mg/mL; mg/mL N 20181231 16047-0026_0f137a5a-0170-4e83-87cd-3d2ae59c35b5 16047-0026 HUMAN OTC DRUG REPASKIN BODY BROAD-SPECTRUM SPF 50 OCTOCRYLENE, TITANIUM DIOXIDE GEL TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part352 Sesderma USA LLC OCTOCRYLENE; TITANIUM DIOXIDE 70; 20 mg/mL; mg/mL N 20181231 16047-0027_ed9d3d7b-06e1-48aa-b2b9-a3c90999d140 16047-0027 HUMAN OTC DRUG DRYSES Antiperspirant 100ml ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20150616 OTC MONOGRAPH FINAL part350 Sesderma USA LLC ALUMINUM CHLOROHYDRATE 160 mg/mL N 20181231 16047-0028_580a9000-c526-4831-8bed-b4a7ceb77816 16047-0028 HUMAN OTC DRUG SALISES FACIAL Moisturizing Acne Treatment Gel 50ml SALICYLIC ACID GEL TOPICAL 20150616 OTC MONOGRAPH FINAL part333D Sesderma USA LLC SALICYLIC ACID 15 mg/mL N 20181231 16047-0029_454d6c30-4bd5-43b5-89ee-fcf397b4f95c 16047-0029 HUMAN OTC DRUG DRYSES Deodorant for men Roll-on 75ml ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20150616 OTC MONOGRAPH FINAL part350 Sesderma USA LLC ALUMINUM CHLOROHYDRATE 144 mg/mL N 20181231 16103-347_fb4fbd19-f19a-4dbd-a4e2-c1793bac5fa1 16103-347 HUMAN OTC DRUG Pharbedryl Diphenhydramine HCl CAPSULE ORAL 20061011 OTC MONOGRAPH FINAL part341 Pharbest Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 16103-348_a45391fb-267c-49ca-926b-8a3a2fad7480 16103-348 HUMAN OTC DRUG Pharbedryl Diphenhydramine HCl CAPSULE ORAL 20061011 OTC MONOGRAPH FINAL part341 Pharbest Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 16103-353_5426fd69-dc29-4b56-ae3a-bdab15e938ec 16103-353 HUMAN OTC DRUG Pharbetol Regular strength Acetaminophen TABLET ORAL 20070109 OTC MONOGRAPH NOT FINAL part343 Pharbest Pharmaceuticals, Inc. ACETAMINOPHEN 325 mg/1 N 20181231 16103-356_1a681eca-eaa3-49e6-9677-66824ae8561f 16103-356 HUMAN OTC DRUG Adult Low Dose Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20070112 OTC MONOGRAPH FINAL part343 Pharbest Pharmaceuticals, Inc. ASPIRIN 81 mg/1 N 20181231 16103-357_ab9291bb-f8a1-4e6a-8c67-4a7d004f8ba4 16103-357 HUMAN OTC DRUG Pharbest Aspirin 325mg Aspirin TABLET, DELAYED RELEASE ORAL 20100920 OTC MONOGRAPH FINAL part343 Pharbest Pharmaceuticals, Inc. ASPIRIN 325 mg/1 N 20181231 16103-363_e3ca2712-ae80-405d-b9e6-57ad99c13dd8 16103-363 HUMAN OTC DRUG Senna Tabs Senna TABLET, FILM COATED ORAL 20070124 OTC MONOGRAPH NOT FINAL part334 Pharbest Pharmaceuticals, Inc. SENNOSIDES A AND B 8.6 mg/1 N 20181231 16103-365_0c69cbcf-e43e-4f2a-a18b-db5c8ce04364 16103-365 HUMAN OTC DRUG Pharbest Regular Strength Aspirin Aspirin TABLET ORAL 20070112 OTC MONOGRAPH FINAL part343 Pharbest Pharmaceuticals, Inc ASPIRIN 325 mg/1 N 20181231 16103-366_ccb8eb4d-8e60-4a8c-a1c2-87bc3fca71a9 16103-366 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20070822 OTC MONOGRAPH FINAL part343 Pharbest Pharmaceuticals, Inc. ASPIRIN 81 mg/1 N 20181231 16103-367_a86fbc38-1f71-4abc-aade-e98304763076 16103-367 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET, DELAYED RELEASE ORAL 20060125 OTC MONOGRAPH NOT FINAL part334 Pharbest Pharmaceuticals Inc. BISACODYL 5 mg/1 N 20181231 16103-376_27d87c86-7535-4032-8b57-c200dc5a503d 16103-376 HUMAN OTC DRUG Pharbetol Acetaminophen TABLET ORAL 20060110 OTC MONOGRAPH NOT FINAL part343 Pharbest Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 16103-377_af6b5439-4697-4120-b7d7-a613b8e06714 16103-377 HUMAN OTC DRUG Calcium Carbonate (Antacid) Calcium Carbonate TABLET ORAL 20061129 OTC MONOGRAPH FINAL part331 Pharbest Pharmaceuticals Inc. CALCIUM CARBONATE 648 mg/1 N 20181231 16103-384_53890faa-599b-4959-9eb4-f141abb61a1a 16103-384 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20070122 OTC MONOGRAPH NOT FINAL part334 Pharbest Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 16103-393_b1099e02-e444-4d8a-97d7-1483202114b4 16103-393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20110118 ANDA ANDA079129 Pharbest Pharmaceuticals, Inc. IBUPROFEN 200 mg/1 N 20181231 16110-026_becbd930-ea5f-11e3-ac10-0800200c9a66 16110-026 HUMAN PRESCRIPTION DRUG Cordran flurandrenolide OINTMENT TOPICAL 19651018 NDA NDA012806 Aqua Pharmaceuticals FLURANDRENOLIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16110-035_becbd930-ea5f-11e3-ac10-0800200c9a66 16110-035 HUMAN PRESCRIPTION DRUG Cordran flurandrenolide CREAM TOPICAL 19651018 NDA NDA012806 Aqua Pharmaceuticals FLURANDRENOLIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16110-052_fca8e801-018a-11e4-9191-0800200c9a66 16110-052 HUMAN PRESCRIPTION DRUG Cordran flurandrenolide LOTION TOPICAL 19630319 NDA NDA013790 Aqua Pharmaceuticals FLURANDRENOLIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16110-071_88114d2e-88be-4882-9f73-13ce33156ea5 16110-071 HUMAN PRESCRIPTION DRUG VELTIN clindamycin phosphate and tretinoin GEL TOPICAL 20100729 NDA NDA050803 Aqua Pharmaceuticals CLINDAMYCIN PHOSPHATE; TRETINOIN 10; .25 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient],Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 16110-075_a6d054f6-c27d-4641-ae0e-a6f59a196f54 16110-075 HUMAN PRESCRIPTION DRUG Monodox doxycycline CAPSULE ORAL 20070131 NDA NDA050641 Aqua Pharmaceuticals, LLC DOXYCYCLINE 75 mg/1 N 20181231 16110-080_c04d8acb-3580-4cc6-ba94-7ed9d02d0afc 16110-080 HUMAN PRESCRIPTION DRUG Xolegel ketoconazole GEL TOPICAL 20060728 NDA NDA021946 Aqua Pharmaceuticals KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 16110-111_bd2e5fe6-f274-449f-949a-54d5e50b5df2 16110-111 HUMAN PRESCRIPTION DRUG Verdeso desonide AEROSOL, FOAM TOPICAL 20061006 NDA NDA021978 Aqua Pharmaceuticals DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16110-259_a6d054f6-c27d-4641-ae0e-a6f59a196f54 16110-259 HUMAN PRESCRIPTION DRUG Monodox doxycycline CAPSULE ORAL 19891229 NDA NDA050641 Aqua Pharmaceuticals, LLC DOXYCYCLINE 100 mg/1 N 20181231 16110-260_a6d054f6-c27d-4641-ae0e-a6f59a196f54 16110-260 HUMAN PRESCRIPTION DRUG Monodox doxycycline CAPSULE ORAL 19920210 NDA NDA050641 Aqua Pharmaceuticals, LLC DOXYCYCLINE 50 mg/1 N 20181231 16110-501_156fa864-aff6-49b1-ae79-e0e590a703f5 16110-501 HUMAN PRESCRIPTION DRUG Acticlate doxycycline hyclate TABLET, COATED ORAL 20140728 NDA NDA205931 Aqua Pharmaceuticals DOXYCYCLINE HYCLATE 75 mg/1 N 20181231 16110-502_156fa864-aff6-49b1-ae79-e0e590a703f5 16110-502 HUMAN PRESCRIPTION DRUG Acticlate doxycycline hyclate TABLET, COATED ORAL 20140728 NDA NDA205931 Aqua Pharmaceuticals DOXYCYCLINE HYCLATE 150 mg/1 N 20181231 16110-518_d5a700c8-7d13-4142-99a0-bc1c2c3e646e 16110-518 HUMAN PRESCRIPTION DRUG Altabax retapamulin OINTMENT TOPICAL 20160501 NDA NDA022055 Aqua Pharmaceuticals RETAPAMULIN 10 mg/1 pleuromutilin [Chemical/Ingredient],Pleuromutilin Antibacterial [EPC] E 20171231 16110-812_469b34ec-95ea-4c01-925f-b44c9374a9cb 16110-812 HUMAN PRESCRIPTION DRUG Fluoroplex fluorouracil CREAM TOPICAL 19931203 NDA NDA016988 Aqua Pharmaceuticals, LLC FLUOROURACIL 10 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 16129-001_5d7f637a-24f9-6a3e-e053-2991aa0a6dd6 16129-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F-18 Fludeoxyglucose F-18 INJECTION INTRAVENOUS 20060329 ANDA ANDA204264 Shertech Laboratories, LLC FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 16129-002_5d8041ed-4731-1859-e053-2991aa0abda3 16129-002 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F 18 INJECTION INTRAVENOUS 20110323 ANDA ANDA204315 Shertech Laboratories, LLC SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 16129-003_5d8041ed-475f-1859-e053-2991aa0abda3 16129-003 HUMAN PRESCRIPTION DRUG Ammonia N 13 AMMONIA N-13 INJECTION INTRAVENOUS 20120612 ANDA ANDA204366 Shertech Laboratories, LLC AMMONIA N-13 260 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 16129-101_5ae22440-c757-9199-e053-2991aa0acad8 16129-101 HUMAN PRESCRIPTION DRUG Contrast Allergy PreMed Pack prednisone, diphenhydramine KIT 20160913 UNAPPROVED DRUG OTHER Shertech Laboratories, LLC N 20181231 16175-0001_d9fa4170-13e3-4807-a537-c9967fcfe715 16175-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20080819 UNAPPROVED MEDICAL GAS Calmar dba A&R Medical Supply OXYGEN 99 L/100L N 20181231 16252-506_9039af24-f39c-1b00-d848-5dc4c9c59dc7 16252-506 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16252-507_9039af24-f39c-1b00-d848-5dc4c9c59dc7 16252-507 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16252-508_9039af24-f39c-1b00-d848-5dc4c9c59dc7 16252-508 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16252-509_9039af24-f39c-1b00-d848-5dc4c9c59dc7 16252-509 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20061220 ANDA ANDA076685 Cobalt Laboratories Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16252-514_e8e07d6f-445c-438c-827f-fa20dfedf0c5 16252-514 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20061101 ANDA ANDA076794 Actavis Pharma, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 16252-515_e8e07d6f-445c-438c-827f-fa20dfedf0c5 16252-515 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20061101 ANDA ANDA076794 Actavis Pharma, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 16252-516_e8e07d6f-445c-438c-827f-fa20dfedf0c5 16252-516 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20061101 ANDA ANDA076794 Actavis Pharma, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 16252-523_f4a4fe4c-5ea0-407b-9662-fa312b9ddfea 16252-523 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080508 ANDA ANDA077532 Actavis Pharma, Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 16252-524_f4a4fe4c-5ea0-407b-9662-fa312b9ddfea 16252-524 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080508 ANDA ANDA077532 Actavis Pharma, Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 16252-525_f4a4fe4c-5ea0-407b-9662-fa312b9ddfea 16252-525 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080508 ANDA ANDA077532 Actavis Pharma, Inc. ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 16252-527_645d9865-eafa-40bc-9532-eecaa126acb0 16252-527 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20061023 20181031 ANDA ANDA076939 Actavis Pharma, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16252-528_645d9865-eafa-40bc-9532-eecaa126acb0 16252-528 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20061023 ANDA ANDA076939 Actavis Pharma, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16252-529_645d9865-eafa-40bc-9532-eecaa126acb0 16252-529 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20071231 20180731 ANDA ANDA076939 Actavis Pharma, Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16252-539_88d5bc5d-fecd-401c-8b64-0b3b07a63f0a 16252-539 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20040105 ANDA ANDA077317 Actavis Pharma, Inc. ISRADIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 16252-540_88d5bc5d-fecd-401c-8b64-0b3b07a63f0a 16252-540 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20060105 ANDA ANDA077317 Actavis Pharma, Inc. ISRADIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 16252-541_774a1827-0512-4db5-b788-5404be50dee2 16252-541 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070613 ANDA ANDA077805 Actavis Pharma, Inc. TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16252-542_774a1827-0512-4db5-b788-5404be50dee2 16252-542 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070613 ANDA ANDA077805 Actavis Pharma, Inc. TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16252-543_774a1827-0512-4db5-b788-5404be50dee2 16252-543 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070613 ANDA ANDA077805 Actavis Pharma, Inc. TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16252-570_6946d7ed-fafe-4bc1-80d4-0289b11fc30e 16252-570 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080505 ANDA ANDA076549 Actavis Pharma, Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16252-571_6946d7ed-fafe-4bc1-80d4-0289b11fc30e 16252-571 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080114 ANDA ANDA076549 Actavis Pharma, Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16252-572_6946d7ed-fafe-4bc1-80d4-0289b11fc30e 16252-572 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071224 ANDA ANDA076549 Actavis Pharma, Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16252-573_6946d7ed-fafe-4bc1-80d4-0289b11fc30e 16252-573 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071224 ANDA ANDA076549 Actavis Pharma, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16252-597_587d1570-8361-4502-89fe-c8d35a8724e1 16252-597 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET, CHEWABLE ORAL 20090122 20180731 ANDA ANDA076928 Actavis Pharma, Inc. LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 16252-598_587d1570-8361-4502-89fe-c8d35a8724e1 16252-598 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET, CHEWABLE ORAL 20090122 20180831 ANDA ANDA076928 Actavis Pharma, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 16252-599_4cc07cdd-2fae-4851-aedf-e6088431addd 16252-599 HUMAN PRESCRIPTION DRUG alendronate sodium alendronate sodium TABLET ORAL 20091023 ANDA ANDA076984 Actavis Pharma, Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 16252-601_4cc07cdd-2fae-4851-aedf-e6088431addd 16252-601 HUMAN PRESCRIPTION DRUG alendronate sodium alendronate sodium TABLET ORAL 20080804 ANDA ANDA076984 Actavis Pharma, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 16252-615_81eed905-2084-44d1-97a7-ab7d63690e68 16252-615 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20160502 20181130 ANDA ANDA079167 Actavis Pharma, Inc. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 16252-616_81eed905-2084-44d1-97a7-ab7d63690e68 16252-616 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20160502 20181030 ANDA ANDA079167 Actavis Pharma, Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 16252-617_81eed905-2084-44d1-97a7-ab7d63690e68 16252-617 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20160502 20181031 ANDA ANDA079167 Actavis Pharma, Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 16252-618_81eed905-2084-44d1-97a7-ab7d63690e68 16252-618 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20160502 20181031 ANDA ANDA079167 Actavis Pharma, Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 16408-2714_e7674795-329b-4f38-b0d4-7b3b82181a7a 16408-2714 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20051006 UNAPPROVED MEDICAL GAS Georgia Respiratory HomeCare & Medical Equipment LLC OXYGEN 99 L/100L E 20171231 16477-101_5f234883-e767-c928-e053-2a91aa0a82c7 16477-101 HUMAN OTC DRUG Rondec-D Chlophedianol Hydrochloride,Pseudoephedrine Hydrochloride LIQUID ORAL 20171121 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC PSEUDOEPHEDRINE HYDROCHLORIDE; CHLOPHEDIANOL HYDROCHLORIDE 30; 12.5 mg/5mL; mg/5mL N 20181231 16477-201_7fea5545-ea59-43e0-8a3d-f2f47b3d2d55 16477-201 HUMAN PRESCRIPTION DRUG Hemmorex-HC hydrocortisone acetate SUPPOSITORY RECTAL 20131112 UNAPPROVED DRUG OTHER Laser Pharmaceuticals, LLC HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16477-306_a85a5622-5f5e-486e-9370-0cb738d82d11 16477-306 HUMAN OTC DRUG Respaire-30 GUAIFENESIN CAPSULE ORAL 20080902 OTC MONOGRAPH FINAL part341 Laser Pharmaceuticals, LLC GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 150; 30 mg/1; mg/1 N 20181231 16480-002_47216f1c-13d0-4335-989f-722ef717850c 16480-002 HUMAN OTC DRUG Chan Yat Hing She Kun Wool Lok Medicated Oil Camphor, Menthol, Turpentine Oil OIL TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part348 Chan Yat Hing Medicine Factory CAMPHOR (SYNTHETIC); METHYL SALICYLATE; MENTHOL; TURPENTINE OIL 9; 5; 39; 18 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 16496-544_0d3836dd-d37e-4078-ba92-38a18f314b70 16496-544 HUMAN OTC DRUG Antiseptic Hand CHLOROXYLENOL SOAP TOPICAL 20050930 OTC MONOGRAPH NOT FINAL part333E Image Supply, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 16555-006_0aa154f3-2406-468f-b650-1163e3111890 16555-006 HUMAN OTC DRUG VIALPROTECTION AGE DEFYING PROTECTIVE SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE OXYBENZONE LOTION TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 DARPHIN DIST. HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE 5; 5; 3; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 16555-007_552e5a85-0e3d-427b-b178-0c554c037c91 16555-007 HUMAN OTC DRUG DARPHIN CC INSTANT MULTI-BENEFIT CARE BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 DARPHIN DIST. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .08175; .0436; .02725; .01199 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 16555-008_4d1481f8-a80b-4056-a74c-d0d02cd7e778 16555-008 HUMAN OTC DRUG INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20170715 OTC MONOGRAPH NOT FINAL part352 DARPHIN DIST. TITANIUM DIOXIDE; ZINC OXIDE 66.64; 42.2 mg/mL; mg/mL N 20181231 16555-996_3771b213-03f0-45e5-9423-bff016c95c56 16555-996 HUMAN OTC DRUG DENBLAN WHITENING FORMULA ANTI CAVITY FLUORIDE SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20040801 OTC MONOGRAPH FINAL part355 DARPHIN DIST. SODIUM MONOFLUOROPHOSPHATE .76 mL/100mL E 20171231 16571-011_d3c75f8e-7b30-4536-862a-74e773853575 16571-011 HUMAN PRESCRIPTION DRUG Theophylline(Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20100915 ANDA ANDA040595 PACK Pharmaceuticals, LLC THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 16571-012_e6d3ddb1-784d-420c-a1ef-7f349cf6f55d 16571-012 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20100615 ANDA ANDA074116 PACK Pharmaceuticals, LLC PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 16571-013_e6d3ddb1-784d-420c-a1ef-7f349cf6f55d 16571-013 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20100615 ANDA ANDA074118 PACK Pharmaceuticals, LLC PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 16571-070_309bc345-79d1-4e7a-80fc-cfafd8e1010b 16571-070 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20121025 ANDA ANDA065412 Pack Pharmaceuticals, LLC CEFACLOR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 16571-071_309bc345-79d1-4e7a-80fc-cfafd8e1010b 16571-071 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20121031 ANDA ANDA065412 Pack Pharmaceuticals, LLC CEFACLOR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 16571-072_309bc345-79d1-4e7a-80fc-cfafd8e1010b 16571-072 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20121031 ANDA ANDA065412 Pack Pharmaceuticals, LLC CEFACLOR 375 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 16571-101_c797d26f-a030-43bc-9d6b-130e2d1665c0 16571-101 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20080620 ANDA ANDA078553 Rising Pharmaceuticals, Inc. DICLOFENAC SODIUM 3.5 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 16571-120_223c4ff2-3525-45a2-9c53-e3c2ee6e51cb 16571-120 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20080320 ANDA ANDA077689 Rising Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 16571-135_45ff37cf-bb29-4e8b-99b4-881967ef61b3 16571-135 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20100915 ANDA ANDA077568 Pack Pharmaceuticals, LLC CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 16571-150_4895e1e1-77b3-4e3a-a1c0-429bd410d7fb 16571-150 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN SOLUTION/ DROPS TOPICAL 20101220 ANDA ANDA077700 Rising Pharmaceuticals, Inc. LEVOFLOXACIN 5 mg/mL N 20181231 16571-160_444a065e-f652-4271-8edb-b1c083812c8a 16571-160 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20101117 ANDA ANDA091630 Rising Pharmaceuticals, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 16571-161_444a065e-f652-4271-8edb-b1c083812c8a 16571-161 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20101117 ANDA ANDA091630 Rising Pharmaceuticals, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 N 20181231 16571-201_a8271d7b-1afb-455a-a941-26e88b966e64 16571-201 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Rising Pharmaceuticals, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 16571-202_a8271d7b-1afb-455a-a941-26e88b966e64 16571-202 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20101231 ANDA ANDA090066 Rising Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 16571-203_a8271d7b-1afb-455a-a941-26e88b966e64 16571-203 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20101231 ANDA ANDA090066 Rising Pharmaceuticals, Inc. DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 16571-210_c6266a40-1ceb-4dec-adc2-a118db7cd6e5 16571-210 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140325 ANDA ANDA076957 Rising Pharmaceuticals, Inc. FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 16571-211_c6266a40-1ceb-4dec-adc2-a118db7cd6e5 16571-211 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140325 ANDA ANDA076957 Rising Pharmaceuticals, Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 16571-212_c6266a40-1ceb-4dec-adc2-a118db7cd6e5 16571-212 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20170301 ANDA ANDA076957 Rising Pharmaceuticals, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 16571-213_c6266a40-1ceb-4dec-adc2-a118db7cd6e5 16571-213 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140325 ANDA ANDA076957 Rising Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 16571-214_3a66b537-63a4-41f9-8415-5ed05bd8cbcf 16571-214 HUMAN PRESCRIPTION DRUG Tindazole Tinidazole TABLET, FILM COATED ORAL 20131009 ANDA ANDA202489 Pack Pharmaceuticals, LLC TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 16571-215_3a66b537-63a4-41f9-8415-5ed05bd8cbcf 16571-215 HUMAN PRESCRIPTION DRUG Tindazole Tinidazole TABLET, FILM COATED ORAL 20131009 ANDA ANDA202489 Pack Pharmaceuticals, LLC TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 16571-301_08a574fb-ce43-4859-a5cf-6f62bd0ca09e 16571-301 HUMAN OTC DRUG Guaifenesin DAC Guaifenesin, Codeine Phosphate and Pseudoephedrine Hydrochloride LIQUID ORAL 20160201 UNAPPROVED DRUG OTHER Rising Pharmaceuticals GUAIFENESIN; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 100; 10; 30 mg/5mL; mg/5mL; mg/5mL CV N 20181231 16571-302_65f0bb94-4134-414c-ac80-f7bbbe1f25d4 16571-302 HUMAN OTC DRUG Guaifenesin AC Guaifenesin and Codeine Phosphate SYRUP ORAL 20150301 UNAPPROVED DRUG OTHER Rising Pharmaceuticals GUAIFENESIN; CODEINE PHOSPHATE 100; 10 mg/5mL; mg/5mL CV N 20181231 16571-330_13cb8795-0e0a-4c4c-bd68-9f95dc872660 16571-330 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital LIQUID ORAL 20160610 UNAPPROVED DRUG OTHER Rising Pharmaceuticals PHENOBARBITAL 20 mg/5mL CIV N 20181231 16571-401_21efc28f-c5fc-48f5-ab25-8cfdf623d76b 16571-401 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Rising Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 16571-402_a5b90591-c0b0-4c42-8e15-297d0c338f65 16571-402 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Rising Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 16571-411_f9acde68-bffb-42b3-a389-0a2ed7773247 16571-411 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Rising Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 16571-412_f9acde68-bffb-42b3-a389-0a2ed7773247 16571-412 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Rising Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 16571-413_f9acde68-bffb-42b3-a389-0a2ed7773247 16571-413 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Rising Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 16571-421_16df11e8-bec0-4a5b-a1da-02663f6f27cf 16571-421 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100601 ANDA ANDA079220 Rising Pharmaceuticals, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 16571-430_d5072024-c824-4740-93af-02340db518ff 16571-430 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100610 ANDA ANDA077443 Pack Pharmaceuticals LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 16571-431_d5072024-c824-4740-93af-02340db518ff 16571-431 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100610 ANDA ANDA077443 Pack Pharmaceuticals LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 16571-441_d5072024-c824-4740-93af-02340db518ff 16571-441 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100610 ANDA ANDA077443 Pack Pharmaceuticals LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 16571-500_a1c2686b-bbf3-4afc-aeb5-84a2f64341e3 16571-500 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20110601 ANDA ANDA091497 Rising Pharmaceuticals, Inc LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 16571-501_a1c2686b-bbf3-4afc-aeb5-84a2f64341e3 16571-501 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 Rising Pharmaceuticals, Inc LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 16571-502_a1c2686b-bbf3-4afc-aeb5-84a2f64341e3 16571-502 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 Rising Pharmaceuticals, Inc LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 16571-600_b8b25259-2c45-4312-bc34-5cab0ccead5b 16571-600 HUMAN PRESCRIPTION DRUG CROMOLYN SODIUM CROMOLYN SODIUM SOLUTION, CONCENTRATE ORAL 20111205 ANDA ANDA202583 Rising Pharmaceuticals, Inc. CROMOLYN SODIUM 100 mg/5mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 16571-657_5ad415e6-8a59-4ac6-aaa5-b095de6777b8 16571-657 HUMAN PRESCRIPTION DRUG Cevimeline Hydrochloride Cevimeline Hydrochloride CAPSULE ORAL 20140617 ANDA ANDA203775 Rising Pharmaceuticals, Inc. CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 16597-4873_66006763-1fd4-4279-8a88-f49494a0ff89 16597-4873 HUMAN OTC DRUG Lekon Herbal Patch Green Menthol,Camphor PATCH TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part348 Taiwan Three Mast Pharmaceutical Company Limited MENTHOL; CAMPHOR (SYNTHETIC) 5.1; 3 g/100g; g/100g E 20171231 16638-042_256e7111-d06f-576e-e054-00144ff88e88 16638-042 HUMAN OTC DRUG Balsamic Liniment Castor Birch LINIMENT TOPICAL 20001222 OTC MONOGRAPH NOT FINAL part334 Borisovskiy Zavod Medicinskikh Preparatov JSC CASTOR OIL; BETULA PENDULA TAR OIL 35.6; 1.2 g/40g; g/40g E 20171231 16638-118_3ace0af2-4f14-4140-e054-00144ff8d46c 16638-118 HUMAN OTC DRUG CITRAMON Aspirin Acetaminophen Caffeine TABLET ORAL 19960626 OTC MONOGRAPH NOT FINAL part343 Borisovskiy Zavod Medicinskikh Preparatov JSC ASPIRIN; ACETAMINOPHEN; CAFFEINE 220; 200; 27 mg/550mg; mg/550mg; mg/550mg E 20171231 16638-166_256e7111-d07a-576e-e054-00144ff88e88 16638-166 HUMAN OTC DRUG IODINE Iodine Alcoholic SOLUTION TOPICAL 19991020 OTC MONOGRAPH NOT FINAL part333A Borisovskiy Zavod Medicinskikh Preparatov JSC IODINE; POTASSIUM IODIDE .5; .2 g/10mL; g/10mL E 20171231 16708-001_23e46dbd-61b3-0bd1-e054-00144ff88e88 16708-001 HUMAN OTC DRUG Skin Beautifying Milk Hydroquinone CREAM TOPICAL 20151027 OTC MONOGRAPH NOT FINAL part358A Bluefield Associates, Inc. HYDROQUINONE .02 g/g N 20181231 16708-002_22c9b304-c3c3-04b4-e054-00144ff88e88 16708-002 HUMAN OTC DRUG Medicated Fade Creme with Sunscreen Hydroquinone and Octinoxate CREAM TOPICAL 20151026 OTC MONOGRAPH NOT FINAL part358A Bluefield Associates, Inc. HYDROQUINONE; OCTINOXATE .02; .025 g/g; g/g N 20181231 16714-021_6faa1858-5aec-4fbd-93df-bbb868ce79e7 16714-021 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20091214 ANDA ANDA078213 Northstar RxLLC PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 16714-022_6faa1858-5aec-4fbd-93df-bbb868ce79e7 16714-022 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20091214 ANDA ANDA078213 Northstar RxLLC PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 16714-023_6faa1858-5aec-4fbd-93df-bbb868ce79e7 16714-023 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20091214 ANDA ANDA078213 Northstar RxLLC PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 16714-024_6faa1858-5aec-4fbd-93df-bbb868ce79e7 16714-024 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20091214 ANDA ANDA078213 Northstar RxLLC PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 16714-025_6faa1858-5aec-4fbd-93df-bbb868ce79e7 16714-025 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20091214 ANDA ANDA078213 Northstar RxLLC PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 16714-041_17fafdca-a354-4d96-a077-b5c4ccbc2f80 16714-041 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20091116 ANDA ANDA078253 Northstar RxLLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 16714-042_17fafdca-a354-4d96-a077-b5c4ccbc2f80 16714-042 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20091116 ANDA ANDA078253 Northstar RxLLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 16714-071_4943b3a8-5f12-4630-aacc-046ac5235fb4 16714-071 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110101 ANDA ANDA078504 Northstar RxLLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 16714-072_4943b3a8-5f12-4630-aacc-046ac5235fb4 16714-072 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110101 ANDA ANDA078401 Northstar RxLLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 16714-073_baa3dc62-65f4-487a-9aee-06b1535b5a1b 16714-073 HUMAN PRESCRIPTION DRUG Norethindrone Norethindrone KIT 20130907 ANDA ANDA200961 Northstar Rx LLC N 20181231 16714-081_801a2fa3-b121-4a62-8341-1c870e4f7143 16714-081 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride TABLET ORAL 20091111 ANDA ANDA040840 Northstar RxLLC HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 16714-082_801a2fa3-b121-4a62-8341-1c870e4f7143 16714-082 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride TABLET ORAL 20091111 ANDA ANDA040840 Northstar RxLLC HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 16714-083_801a2fa3-b121-4a62-8341-1c870e4f7143 16714-083 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride TABLET ORAL 20091111 ANDA ANDA040840 Northstar RxLLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 16714-101_4386105e-f3cd-4880-933c-e46457117fd1 16714-101 HUMAN PRESCRIPTION DRUG Gemfibrozil gemfibrozil TABLET ORAL 20101220 ANDA ANDA079072 Northstar RxLLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 16714-221_1193d0e4-4651-42a6-a0ea-21de989a648f 16714-221 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET, FILM COATED ORAL 20080429 ANDA ANDA078678 Northstar Rx LLC GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 16714-221_2a0fee46-257c-45ac-96e9-d32a55c7e95f 16714-221 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET, FILM COATED ORAL 20080429 ANDA ANDA078678 Northstar Rx LLC GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 16714-224_b3ccb962-a69d-4453-988f-282ef62ec38c 16714-224 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 NorthStar Rx LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 16714-225_b3ccb962-a69d-4453-988f-282ef62ec38c 16714-225 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 NorthStar Rx LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 16714-226_b3ccb962-a69d-4453-988f-282ef62ec38c 16714-226 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 NorthStar Rx LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 16714-234_b586f5fd-f5a4-4a25-a246-14a5f668b201 16714-234 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NorthStar Rx LLC PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 16714-235_b586f5fd-f5a4-4a25-a246-14a5f668b201 16714-235 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NorthStar Rx LLC PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 16714-271_dd9c2f66-9d9c-41e9-bdd1-fb1f65dee82b 16714-271 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20091019 ANDA ANDA078862 Northstar Rx LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 16714-292_055ff8ec-9744-40ce-b04c-8a01a12b6ddd 16714-292 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 NorthStar Rx LLC AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 16714-293_055ff8ec-9744-40ce-b04c-8a01a12b6ddd 16714-293 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 NorthStar Rx LLC AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 16714-294_dd6c98b5-aa17-4c0d-b631-d90e8f8348ac 16714-294 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201091 NorthStar Rx LLC AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 16714-295_96aa75df-b838-44d6-a23c-343816d87455 16714-295 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091569 NorthStar Rx LLC AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 16714-296_96aa75df-b838-44d6-a23c-343816d87455 16714-296 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091569 NorthStar Rx LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 16714-297_96aa75df-b838-44d6-a23c-343816d87455 16714-297 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091568 NorthStar Rx LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 16714-298_0cd4b836-2114-4dfe-9018-32d8652522f9 16714-298 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NorthStar Rx LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 16714-299_0cd4b836-2114-4dfe-9018-32d8652522f9 16714-299 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NorthStar Rx LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 16714-300_6dd65f3f-ae1c-4cef-8677-4d5c7569c4ba 16714-300 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 NorthStar Rx LLC FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 16714-304_6dd65f3f-ae1c-4cef-8677-4d5c7569c4ba 16714-304 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 NorthStar Rx LLC FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 16714-305_6dd65f3f-ae1c-4cef-8677-4d5c7569c4ba 16714-305 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 NorthStar Rx LLC FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 16714-311_16f95a4f-2f1f-48c0-8501-c5dc2232a5d7 16714-311 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 NorthStar RxLLC VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-312_16f95a4f-2f1f-48c0-8501-c5dc2232a5d7 16714-312 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 NorthStar RxLLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-313_16f95a4f-2f1f-48c0-8501-c5dc2232a5d7 16714-313 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 NorthStar RxLLC VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-314_16f95a4f-2f1f-48c0-8501-c5dc2232a5d7 16714-314 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 NorthStar RxLLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-315_16f95a4f-2f1f-48c0-8501-c5dc2232a5d7 16714-315 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20101221 ANDA ANDA078932 NorthStar RxLLC VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-321_59f78db7-1569-4058-8c73-04ba75523f81 16714-321 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20110506 ANDA ANDA091369 NorthStar RxLLC LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] N 20181231 16714-330_22484fdb-31bc-467c-9671-f5bd9b00b50e 16714-330 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 NorthStar Rx LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-331_59f78db7-1569-4058-8c73-04ba75523f81 16714-331 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20110506 ANDA ANDA091369 NorthStar RxLLC LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] N 20181231 16714-332_22484fdb-31bc-467c-9671-f5bd9b00b50e 16714-332 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 NorthStar Rx LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-340_27416581-5fc6-4e63-9a68-8a1057181544 16714-340 HUMAN PRESCRIPTION DRUG Levonest levonorgestrel and ethinyl estradiol KIT 20101229 ANDA ANDA090719 Northstar Rx LLC N 20181231 16714-346_a6c260ec-0409-4eae-96fb-49aab7584fc0 16714-346 HUMAN PRESCRIPTION DRUG Dasetta 7/7/7 Norethindrone and Ethinyl Estradiol KIT ORAL 20120601 ANDA ANDA090946 Northstar Rx LLC N 20181231 16714-347_f3ea19d8-a47e-4dbc-badb-4d3cf7d4925c 16714-347 HUMAN PRESCRIPTION DRUG PHILITH Norethindrone and Ethinyl Estradiol Tablets KIT ORAL 20111222 ANDA ANDA090947 Northstar Rx LLC N 20181231 16714-348_dca50141-ad1d-451f-b9fd-89fe4caa24b1 16714-348 HUMAN PRESCRIPTION DRUG Dasetta 1/35 Norethindrone and Ethinyl Estradiol KIT ORAL 20120601 ANDA ANDA090948 Northstar Rx LLC N 20181231 16714-351_127ca6a7-a1a4-40cb-bcc3-05dcd0816514 16714-351 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20090701 ANDA ANDA090223 NorthStar RxLLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-352_127ca6a7-a1a4-40cb-bcc3-05dcd0816514 16714-352 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20090701 ANDA ANDA090223 NorthStar RxLLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-353_127ca6a7-a1a4-40cb-bcc3-05dcd0816514 16714-353 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20090701 ANDA ANDA090223 NorthStar RxLLC FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-354_58cb5fca-cd33-4b3f-93bb-467802bff58c 16714-354 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 NorthStar Rx LLC LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-355_58cb5fca-cd33-4b3f-93bb-467802bff58c 16714-355 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 NorthStar Rx LLC LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-356_58cb5fca-cd33-4b3f-93bb-467802bff58c 16714-356 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 NorthStar Rx LLC LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-357_58cb5fca-cd33-4b3f-93bb-467802bff58c 16714-357 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 NorthStar Rx LLC LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-358_c3eb5c0f-763f-4f63-9bbd-52180f147738 16714-358 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090115 ANDA ANDA079063 NorthStar Rx LLC LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-359_8f8fe8b4-23bc-48f1-a387-f6f8dc1d7bc7 16714-359 HUMAN PRESCRIPTION DRUG Falmina levonorgestrel and ethinyl estradiol KIT 20130913 ANDA ANDA090721 Northstar Rx LLC N 20181231 16714-360_9e380d90-565f-4d43-bdaf-f96ca8c1d9a3 16714-360 HUMAN PRESCRIPTION DRUG Mono-Linyah norgestimate and ethinyl estradiol KIT 20120523 ANDA ANDA090523 Northstar Rx LLC N 20181231 16714-363_82c7c4bf-8bb9-4777-b92a-97f8f6048ec3 16714-363 HUMAN PRESCRIPTION DRUG Tri-Linyah Norgestimate and Ethinyl Estradiol KIT 20120530 ANDA ANDA090524 Northstar Rx LLC N 20181231 16714-365_7bf18078-3e39-4683-b93d-36d319afb241 16714-365 HUMAN PRESCRIPTION DRUG Elinest Norgestrel and Ethinyl Estradiol KIT 20120107 ANDA ANDA091105 Northstar Rx LLC N 20181231 16714-366_fad78cc6-9849-432f-a441-d71529d03041 16714-366 HUMAN PRESCRIPTION DRUG SETLAKIN Levonorgestrel and Ethinyl Estradiol KIT 20150801 ANDA ANDA090716 Northstar Rx LLC N 20181231 16714-367_bb80f02e-e555-486e-b941-a1f1a9279186 16714-367 HUMAN PRESCRIPTION DRUG Desogestrel and Ethinyl Estradiol Desogestrel and Ethinyl Estradiol KIT 20140530 ANDA ANDA091234 Northstar Rx LLC N 20181231 16714-370_eddb3619-4f94-4872-a3e4-09ac31e27937 16714-370 HUMAN PRESCRIPTION DRUG Wera Norethindrone and Ethinyl Estradiol KIT ORAL 20120601 ANDA ANDA091204 Northstar Rx LLC N 20181231 16714-371_9092846a-7e10-4862-b8db-90f9d151162f 16714-371 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130101 ANDA ANDA090607 NorthStar RxLLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-372_9092846a-7e10-4862-b8db-90f9d151162f 16714-372 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130101 ANDA ANDA090607 NorthStar RxLLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-373_9092846a-7e10-4862-b8db-90f9d151162f 16714-373 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130101 ANDA ANDA090607 NorthStar RxLLC LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-374_9092846a-7e10-4862-b8db-90f9d151162f 16714-374 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130101 ANDA ANDA090607 NorthStar RxLLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-388_2961d11e-20e3-447f-8b03-6a479af7bd8a 16714-388 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070125 ANDA ANDA065352 NorthStar Rx LLC CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 16714-389_63ddad42-d307-4da8-9b0b-19bec6de83eb 16714-389 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20130425 ANDA ANDA065349 NorthStar Rx LLC CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 16714-390_63ddad42-d307-4da8-9b0b-19bec6de83eb 16714-390 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20130425 ANDA ANDA065349 NorthStar Rx LLC CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 16714-391_9718e087-526d-4160-a6a9-ec9ee9b53ac9 16714-391 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107 ANDA ANDA065434 NorthStar Rx LLC CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 16714-392_9ea0bf01-79fc-4ea1-b5d2-8edda5684636 16714-392 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 NorthStar Rx LLC CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 16714-393_9ea0bf01-79fc-4ea1-b5d2-8edda5684636 16714-393 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 NorthStar Rx LLC CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 16714-394_a6e3ad82-8d09-4cc3-92f1-6624c8154771 16714-394 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 NorthStar Rx LLC CEFPODOXIME PROXETIL 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 16714-395_a6e3ad82-8d09-4cc3-92f1-6624c8154771 16714-395 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 NorthStar Rx LLC CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 16714-396_138dedfa-5652-4240-ae4c-8b06a9f48964 16714-396 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070130 ANDA ANDA065381 NorthStar Rx LLC CEFPROZIL 125 mg/5mL N 20181231 16714-397_138dedfa-5652-4240-ae4c-8b06a9f48964 16714-397 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070130 ANDA ANDA065381 NorthStar Rx LLC CEFPROZIL 250 mg/5mL N 20181231 16714-398_a1b20b8f-0f7b-45e8-b1b6-adda4d799251 16714-398 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 NorthStar Rx LLC CEFPROZIL 250 mg/1 N 20191231 16714-399_a1b20b8f-0f7b-45e8-b1b6-adda4d799251 16714-399 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 NorthStar Rx LLC CEFPROZIL 500 mg/1 N 20191231 16714-400_d5909167-d375-462f-9862-6417e413ae8e 16714-400 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 NorthStar Rx LLC CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 16714-401_d5909167-d375-462f-9862-6417e413ae8e 16714-401 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 NorthStar Rx LLC CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 16714-402_504422f8-3d4f-4063-9b48-c9e6e85422bc 16714-402 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20070608 ANDA ANDA065409 NorthStar Rx LLC CEFPODOXIME PROXETIL 50 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 16714-403_504422f8-3d4f-4063-9b48-c9e6e85422bc 16714-403 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20070608 ANDA ANDA065409 NorthStar Rx LLC CEFPODOXIME PROXETIL 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 16714-404_e7b53001-2747-4c4f-9780-6768ac410d85 16714-404 HUMAN PRESCRIPTION DRUG PIMTREA desogestrel/ethinyl estradiol and ethinyl estradiol KIT 20130801 ANDA ANDA091247 Northstar Rx LLC N 20181231 16714-405_deb5c5e8-39d2-4809-9043-a2bfcc336ba9 16714-405 HUMAN PRESCRIPTION DRUG Larin Fe 1.5/30 Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate KIT 20130823 ANDA ANDA091453 Northstar Rx LLC N 20181231 16714-406_ecd6556a-5fa8-49db-a262-6b2e9b9d0724 16714-406 HUMAN PRESCRIPTION DRUG Larin Fe 1/20 Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate KIT 20130826 ANDA ANDA091454 Northstar Rx LLC N 20181231 16714-407_a3482b02-4873-4d74-ad69-01d09e974bbe 16714-407 HUMAN PRESCRIPTION DRUG Larin 1.5/30 Norethindrone Acetate/Ethinyl Estradiol KIT 20140320 ANDA ANDA202996 Northstar Rx LLC N 20181231 16714-408_58217efa-7463-4a8e-851b-5661581b66c6 16714-408 HUMAN PRESCRIPTION DRUG Larin 1/20 Norethindrone Acetate/Ethinyl Estradiol KIT 20131204 ANDA ANDA202995 Northstar Rx LLC N 20181231 16714-411_fd2331cc-634f-451e-9982-99974ecc8a0a 16714-411 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20160901 ANDA ANDA207938 Northstar Rx LLC PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 16714-412_fd2331cc-634f-451e-9982-99974ecc8a0a 16714-412 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20160901 ANDA ANDA207938 Northstar Rx LLC PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 16714-413_f7fd1680-b0c7-4e2b-9726-de253a96a2d9 16714-413 HUMAN PRESCRIPTION DRUG Norethindrone Norethindrone KIT 20130910 ANDA ANDA202014 Northstar Rx LLC N 20181231 16714-416_9e370d06-3c85-4f0e-bf6c-08a90e3c6ff1 16714-416 HUMAN PRESCRIPTION DRUG Larin 24 Fe Norethindrone acetate/Ethinyl Estradiol and Ferrous Fumarate KIT 20150218 ANDA ANDA202994 Northstar Rx LLC N 20181231 16714-417_ff0239c9-dacb-4f86-8ad8-7f1a01432227 16714-417 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide 50 mg-25 mg Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 NorthStar RxLLC METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 16714-418_ff0239c9-dacb-4f86-8ad8-7f1a01432227 16714-418 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide 100 mg-25 mg Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 NorthStar RxLLC METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 16714-419_ff0239c9-dacb-4f86-8ad8-7f1a01432227 16714-419 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide 100 mg-50 mg Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 NorthStar RxLLC METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 100; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 16714-439_e52a014f-761d-4ece-8228-6e930484775e 16714-439 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 20141101 ANDA ANDA077066 Northstar RxLLC NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 16714-440_d252f1cc-65a4-40d0-882d-1a229488f702 16714-440 HUMAN PRESCRIPTION DRUG DEBLITANE Norethindrone KIT 20130913 ANDA ANDA202014 Northstar Rx LLC N 20181231 16714-441_db54ab6d-4385-4a55-b77f-34b8551a7803 16714-441 HUMAN PRESCRIPTION DRUG SHAROBEL Norethindrone KIT 20130913 ANDA ANDA200961 Northstar Rx LLC N 20181231 16714-442_30b269f8-3d17-4c59-90d7-7b26e0644f42 16714-442 HUMAN PRESCRIPTION DRUG Enalapril Maleate enalapril maleate TABLET ORAL 20150806 ANDA ANDA075496 Northstar RxLLC ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 16714-443_30b269f8-3d17-4c59-90d7-7b26e0644f42 16714-443 HUMAN PRESCRIPTION DRUG Enalapril Maleate enalapril maleate TABLET ORAL 20150806 ANDA ANDA075496 Northstar RxLLC ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 16714-444_30b269f8-3d17-4c59-90d7-7b26e0644f42 16714-444 HUMAN PRESCRIPTION DRUG Enalapril Maleate enalapril maleate TABLET ORAL 20150806 ANDA ANDA075459 Northstar RxLLC ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 16714-445_30b269f8-3d17-4c59-90d7-7b26e0644f42 16714-445 HUMAN PRESCRIPTION DRUG Enalapril Maleate enalapril maleate TABLET ORAL 20150806 ANDA ANDA075459 Northstar RxLLC ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 16714-446_1262e4f6-13fa-4dc7-9b54-de3c6277137c 16714-446 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20141201 ANDA ANDA085969 Northstar RxLLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20191231 16714-447_1262e4f6-13fa-4dc7-9b54-de3c6277137c 16714-447 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20141201 ANDA ANDA085966 Northstar RxLLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 16714-448_1262e4f6-13fa-4dc7-9b54-de3c6277137c 16714-448 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20141201 ANDA ANDA085968 Northstar RxLLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 16714-449_1262e4f6-13fa-4dc7-9b54-de3c6277137c 16714-449 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20141201 ANDA ANDA085971 Northstar RxLLC AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20191231 16714-450_1262e4f6-13fa-4dc7-9b54-de3c6277137c 16714-450 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20141201 ANDA ANDA085967 Northstar RxLLC AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20191231 16714-451_1262e4f6-13fa-4dc7-9b54-de3c6277137c 16714-451 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20141201 ANDA ANDA085970 Northstar RxLLC AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20191231 16714-452_55d6f57d-a2a6-301c-e054-00144ff88e88 16714-452 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20150112 ANDA ANDA202152 Northstar RxLLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 16714-453_55d6f57d-a2a6-301c-e054-00144ff88e88 16714-453 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20150112 ANDA ANDA202152 Northstar RxLLC QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 16714-454_55d6f57d-a2a6-301c-e054-00144ff88e88 16714-454 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20150112 ANDA ANDA202152 Northstar RxLLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 16714-455_55d6f57d-a2a6-301c-e054-00144ff88e88 16714-455 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20150112 ANDA ANDA202152 Northstar RxLLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 16714-456_55d6f57d-a2a6-301c-e054-00144ff88e88 16714-456 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20150112 ANDA ANDA202152 Northstar RxLLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 16714-457_55d6f57d-a2a6-301c-e054-00144ff88e88 16714-457 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20150112 ANDA ANDA202152 Northstar RxLLC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 16714-463_a85755e6-14e7-42d0-9679-d834e2ed35bb 16714-463 HUMAN OTC DRUG Her style Levonorgestrel TABLET ORAL 20161101 ANDA ANDA207976 Northstar Rx LLC LEVONORGESTREL 1.5 mg/1 N 20181231 16714-464_e5111c68-8f1e-4628-80ce-372c8ffc241b 16714-464 HUMAN PRESCRIPTION DRUG Juleber desogestrel and ethinyl estradiol KIT 20130712 ANDA ANDA091234 Northstar Rx LLC N 20181231 16714-465_413f5320-514e-6fbd-e054-00144ff8d46c 16714-465 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION INTRAVENOUS 20160101 NDA NDA201195 Northstar RxLLC DOCETAXEL ANHYDROUS 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 16714-467_55517295-1215-4930-e054-00144ff8d46c 16714-467 HUMAN PRESCRIPTION DRUG CAPECITABINE CAPECITABINE TABLET, FILM COATED ORAL 20151101 ANDA ANDA202593 Northstar RxLLC CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 16714-468_55517295-1215-4930-e054-00144ff8d46c 16714-468 HUMAN PRESCRIPTION DRUG CAPECITABINE CAPECITABINE TABLET, FILM COATED ORAL 20151101 ANDA ANDA202593 Northstar RxLLC CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 16714-469_ee847314-510d-44d5-90bb-7be0c81724d6 16714-469 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20160701 ANDA ANDA074979 Northstar RxLLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 16714-470_ee847314-510d-44d5-90bb-7be0c81724d6 16714-470 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20160701 ANDA ANDA074979 Northstar RxLLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 16714-471_ee847314-510d-44d5-90bb-7be0c81724d6 16714-471 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20160701 ANDA ANDA074979 Northstar RxLLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 16714-474_0fd6ecfd-3e5d-4553-8609-326ef96b27fb 16714-474 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20151218 ANDA ANDA040104 Northstar RxLLC HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] E 20171231 16714-476_d6bff811-a6ea-4e4e-a4eb-b34b966cdb40 16714-476 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20151101 ANDA ANDA065189 Northstar RxLLC AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 16714-477_d6bff811-a6ea-4e4e-a4eb-b34b966cdb40 16714-477 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20151101 ANDA ANDA065064 Northstar RxLLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 16714-478_bf96bbb1-7106-411d-ad8f-f57acbba207a 16714-478 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20151101 ANDA ANDA065093 Northstar RxLLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 16714-481_07cf4d56-4663-4483-b013-06fc6d9a5241 16714-481 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20160406 ANDA ANDA075964 Northstar Rx LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 16714-482_9a138058-4ed2-425b-af1b-8ef47a7f8104 16714-482 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20160201 ANDA ANDA075209 Northstar RxLLC LORATADINE 10 mg/1 N 20191231 16714-483_0e597f26-318b-4b24-bb90-05abfe2741f8 16714-483 HUMAN PRESCRIPTION DRUG Clindamycin Palmitate Hydrochloride (Pediatric) Clindamycin Palmitate Hydrochloride (Pediatric) SOLUTION ORAL 20130430 ANDA ANDA202409 NorthStar Rx LLC CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 16714-484_5c0fddda-3d9a-4f6e-8100-1c7f49ee76d9 16714-484 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140602 ANDA ANDA202419 NorthStar Rx LLC DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-485_5c0fddda-3d9a-4f6e-8100-1c7f49ee76d9 16714-485 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140602 ANDA ANDA202419 NorthStar Rx LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-494_bf96bbb1-7106-411d-ad8f-f57acbba207a 16714-494 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20160201 ANDA ANDA065117 Northstar RxLLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 16714-496_9b6145a0-926d-4e98-af5e-5a2694f032f3 16714-496 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20010529 ANDA ANDA075673 NORTHSTAR RX LLC CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .64 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16714-497_fe55fa6c-7290-4cc5-9f01-e7610b14343a 16714-497 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 NORTHSTAR RX LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 16714-498_fe55fa6c-7290-4cc5-9f01-e7610b14343a 16714-498 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 NORTHSTAR RX LLC ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 16714-499_fe55fa6c-7290-4cc5-9f01-e7610b14343a 16714-499 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 NORTHSTAR RX LLC ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 16714-500_413f5320-514e-6fbd-e054-00144ff8d46c 16714-500 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION INTRAVENOUS 20160101 NDA NDA201195 Northstar RxLLC DOCETAXEL ANHYDROUS 80 mg/4mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 16714-501_99b48361-427d-420e-ab8e-5f544192b7bd 16714-501 HUMAN PRESCRIPTION DRUG terbinafine hydrochloride terbinafine hydrochloride TABLET ORAL 20090915 ANDA ANDA078163 Northstar Rx LLC TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 16714-502_397ece59-0740-4980-8953-0003b8b35c70 16714-502 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 19990630 ANDA ANDA075008 NORTHSTAR RX LLC FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16714-503_ed396f00-8325-4966-905b-bf5dd69e8284 16714-503 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160506 ANDA ANDA090858 NorthStar RxLLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-504_ed396f00-8325-4966-905b-bf5dd69e8284 16714-504 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160506 ANDA ANDA090858 NorthStar RxLLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-505_ed396f00-8325-4966-905b-bf5dd69e8284 16714-505 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160506 ANDA ANDA090858 NorthStar RxLLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-508_8433f100-73fb-43fd-b726-54f648417e90 16714-508 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20161126 ANDA ANDA204228 Northstar Rx LLC OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 16714-509_8433f100-73fb-43fd-b726-54f648417e90 16714-509 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20161130 ANDA ANDA204228 Northstar Rx LLC OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 16714-510_04d8e8a3-5df5-4598-a886-7cdf874b221b 16714-510 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20170501 ANDA ANDA205085 NorthStar RxLLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 16714-514_e5109ba5-b131-4135-9a5f-a4f9c4f74e17 16714-514 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET ORAL 20160704 ANDA ANDA206181 Northstar Rx LLC VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 16714-515_e5109ba5-b131-4135-9a5f-a4f9c4f74e17 16714-515 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET ORAL 20160704 ANDA ANDA206181 Northstar Rx LLC VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 16714-531_7cda6d22-a1fc-4ef6-9639-00ea7af79f4f 16714-531 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan TABLET, FILM COATED ORAL 20110103 ANDA ANDA078284 Northstar Rx LLC SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 16714-532_7cda6d22-a1fc-4ef6-9639-00ea7af79f4f 16714-532 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan TABLET, FILM COATED ORAL 20110103 ANDA ANDA078284 Northstar Rx LLC SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 16714-533_7cda6d22-a1fc-4ef6-9639-00ea7af79f4f 16714-533 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan TABLET, FILM COATED ORAL 20110103 ANDA ANDA078284 Northstar Rx LLC SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 16714-551_92669eb5-8903-4c92-bb25-65c85d4092df 16714-551 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20100623 ANDA ANDA090374 Northstar Rx LLC ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 16714-561_92669eb5-8903-4c92-bb25-65c85d4092df 16714-561 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20100623 ANDA ANDA090374 Northstar Rx LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 16714-571_047b2495-cc1a-42b2-ab41-987380e6ef15 16714-571 HUMAN PRESCRIPTION DRUG Bicalutamide bicalutamide TABLET, FILM COATED ORAL 20090828 ANDA ANDA078634 Northstar RxLLC BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 16714-590_d962c08b-5796-46ec-b299-17606ba072e4 16714-590 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20160912 ANDA ANDA076363 Northstar Rx LLC DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20191231 16714-591_d962c08b-5796-46ec-b299-17606ba072e4 16714-591 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20160912 ANDA ANDA076363 Northstar Rx LLC DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20191231 16714-601_d1639e97-241f-4e93-beb0-41b605fc977f 16714-601 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride SOLUTION ORAL 20081031 ANDA ANDA078861 NorthStar Rx LLC SERTRALINE HYDROCHLORIDE 20 mg/mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-611_4b58d905-f192-43fd-b542-a7ebc3eaa649 16714-611 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 NorthStar Rx LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-612_4b58d905-f192-43fd-b542-a7ebc3eaa649 16714-612 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 NorthStar Rx LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-613_4b58d905-f192-43fd-b542-a7ebc3eaa649 16714-613 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 NorthStar Rx LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-614_a0944b55-eb75-4a39-bc79-4bf183408604 16714-614 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET ORAL 20170201 ANDA ANDA078278 NorthStar RxLLC FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 16714-615_a0944b55-eb75-4a39-bc79-4bf183408604 16714-615 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET ORAL 20170201 ANDA ANDA078278 NorthStar RxLLC FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 16714-616_a0944b55-eb75-4a39-bc79-4bf183408604 16714-616 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET ORAL 20170201 ANDA ANDA078278 NorthStar RxLLC FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 16714-621_56470688-bb21-4f2d-b506-5644cc805a63 16714-621 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070504 ANDA ANDA078413 NorthStar Rx LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 16714-622_56470688-bb21-4f2d-b506-5644cc805a63 16714-622 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070504 ANDA ANDA078413 NorthStar Rx LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 16714-623_6a8aa571-e79c-d883-2353-c4633faeca41 16714-623 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20170620 ANDA ANDA202383 NorthStar Rx LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-624_6a8aa571-e79c-d883-2353-c4633faeca41 16714-624 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20170620 ANDA ANDA202383 NorthStar Rx LLC LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-625_6a8aa571-e79c-d883-2353-c4633faeca41 16714-625 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20170620 ANDA ANDA202383 NorthStar Rx LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-626_6a8aa571-e79c-d883-2353-c4633faeca41 16714-626 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20170620 ANDA ANDA202383 NorthStar Rx LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-627_6a8aa571-e79c-d883-2353-c4633faeca41 16714-627 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20170620 ANDA ANDA202383 NorthStar Rx LLC LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-631_c247f3fa-3439-492e-8aba-0096fa427fc3 16714-631 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 NorthStar Rx LLC ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 16714-632_c247f3fa-3439-492e-8aba-0096fa427fc3 16714-632 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 NorthStar Rx LLC ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 16714-633_c247f3fa-3439-492e-8aba-0096fa427fc3 16714-633 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 NorthStar Rx LLC ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 16714-651_7ded1056-ddc5-42b9-9f0c-e7506830650b 16714-651 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 NorthStar Rx LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 16714-652_7ded1056-ddc5-42b9-9f0c-e7506830650b 16714-652 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 NorthStar Rx LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 16714-653_7ded1056-ddc5-42b9-9f0c-e7506830650b 16714-653 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 NorthStar Rx LLC CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 16714-655_2b4f3839-4ad4-4b2e-820c-a4c80158c157 16714-655 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20170126 ANDA ANDA078627 Northstar Rx LLC VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-656_2b4f3839-4ad4-4b2e-820c-a4c80158c157 16714-656 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20170126 ANDA ANDA078627 Northstar Rx LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-657_2b4f3839-4ad4-4b2e-820c-a4c80158c157 16714-657 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20170126 ANDA ANDA078627 Northstar Rx LLC VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-658_2b4f3839-4ad4-4b2e-820c-a4c80158c157 16714-658 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20170126 ANDA ANDA078627 Northstar Rx LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-659_2b4f3839-4ad4-4b2e-820c-a4c80158c157 16714-659 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20170126 ANDA ANDA078627 Northstar Rx LLC VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16714-660_6918f560-2c24-44f2-bf38-d22d4d0487cb 16714-660 HUMAN PRESCRIPTION DRUG Omega-3-Acid Ethyl Esters Omega-3-Acid Ethyl Esters CAPSULE, LIQUID FILLED ORAL 20151130 ANDA ANDA204940 NorthStar Rx LLC OMEGA-3-ACID ETHYL ESTERS 1 g/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 16714-661_15b3e567-278e-4f0c-bf12-a484953f3bb9 16714-661 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 NorthStar Rx LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-662_15b3e567-278e-4f0c-bf12-a484953f3bb9 16714-662 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 NorthStar Rx LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-663_15b3e567-278e-4f0c-bf12-a484953f3bb9 16714-663 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 NorthStar Rx LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16714-668_f2b76f0b-02d4-471c-b835-bd37d1844f8f 16714-668 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir OINTMENT TOPICAL 20140103 ANDA ANDA204605 NorthStar Rx LLC ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 16714-671_557490ee-dcf3-4ac5-a3d7-60dd90db3b14 16714-671 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride SOLUTION ORAL 20071128 ANDA ANDA078776 NorthStar Rx LLC ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 16714-681_a1868ae2-0f3d-4f2b-8d2a-ef7056194c18 16714-681 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NorthStar Rx LLC SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16714-682_a1868ae2-0f3d-4f2b-8d2a-ef7056194c18 16714-682 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NorthStar Rx LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16714-683_a1868ae2-0f3d-4f2b-8d2a-ef7056194c18 16714-683 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NorthStar Rx LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16714-684_a1868ae2-0f3d-4f2b-8d2a-ef7056194c18 16714-684 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NorthStar Rx LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16714-685_a1868ae2-0f3d-4f2b-8d2a-ef7056194c18 16714-685 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 NorthStar Rx LLC SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16714-691_362a57d8-a4bd-4e40-9fae-5ab776c6e3bb 16714-691 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 NorthStar Rx LLC FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 16714-692_362a57d8-a4bd-4e40-9fae-5ab776c6e3bb 16714-692 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 NorthStar Rx LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 16714-693_362a57d8-a4bd-4e40-9fae-5ab776c6e3bb 16714-693 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 NorthStar Rx LLC FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 16714-694_362a57d8-a4bd-4e40-9fae-5ab776c6e3bb 16714-694 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 NorthStar Rx LLC FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 16714-695_866cff1d-b75d-4765-aba2-f58d59a078b3 16714-695 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20090918 ANDA ANDA079150 NorthStar Rx LLC FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 16714-696_866cff1d-b75d-4765-aba2-f58d59a078b3 16714-696 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20090918 ANDA ANDA079150 NorthStar Rx LLC FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 16714-697_d4dd2021-8eea-4bd6-b0e5-f30c6637b5c4 16714-697 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 NorthStar Rx LLC VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 16714-698_d4dd2021-8eea-4bd6-b0e5-f30c6637b5c4 16714-698 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 NorthStar Rx LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 16714-700_7462b376-1b99-4e7f-826c-0f35368dd8be 16714-700 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078956 NorthStar Rx LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-701_7462b376-1b99-4e7f-826c-0f35368dd8be 16714-701 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078956 NorthStar Rx LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-702_7462b376-1b99-4e7f-826c-0f35368dd8be 16714-702 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078956 NorthStar Rx LLC LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-703_7462b376-1b99-4e7f-826c-0f35368dd8be 16714-703 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078956 NorthStar Rx LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 16714-704_f27f254e-8d44-4442-84fb-f0745a5342fb 16714-704 HUMAN PRESCRIPTION DRUG imatinib mesylate imatinib mesylate TABLET, FILM COATED ORAL 20171101 ANDA ANDA078340 NorthStar RxLLC IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 16714-705_f27f254e-8d44-4442-84fb-f0745a5342fb 16714-705 HUMAN PRESCRIPTION DRUG imatinib mesylate imatinib mesylate TABLET, FILM COATED ORAL 20171101 ANDA ANDA078340 NorthStar RxLLC IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 16714-706_0039f505-7cd0-4d79-b5dd-bf2d172571a0 16714-706 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20170411 ANDA ANDA076541 Northstar Rx LLC MIRTAZAPINE 7.5 mg/1 N 20181231 16714-707_0039f505-7cd0-4d79-b5dd-bf2d172571a0 16714-707 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20170411 ANDA ANDA076541 Northstar Rx LLC MIRTAZAPINE 15 mg/1 N 20181231 16714-708_0039f505-7cd0-4d79-b5dd-bf2d172571a0 16714-708 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20170411 ANDA ANDA076541 Northstar Rx LLC MIRTAZAPINE 30 mg/1 N 20181231 16714-709_0039f505-7cd0-4d79-b5dd-bf2d172571a0 16714-709 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20170411 ANDA ANDA076541 Northstar Rx LLC MIRTAZAPINE 45 mg/1 N 20181231 16714-713_ffdbcae6-7215-4c74-84c3-466528e20592 16714-713 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20170501 ANDA ANDA090931 NorthStar RxLLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 16714-717_cb02adf4-f5f9-47dd-9f63-349dfc71317a 16714-717 HUMAN PRESCRIPTION DRUG ENTECAVIR ENTECAVIR TABLET, FILM COATED ORAL 20170615 ANDA ANDA206872 NorthStar RxLLC ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 16714-718_cb02adf4-f5f9-47dd-9f63-349dfc71317a 16714-718 HUMAN PRESCRIPTION DRUG ENTECAVIR ENTECAVIR TABLET, FILM COATED ORAL 20170615 ANDA ANDA206872 NorthStar RxLLC ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 16714-725_79f87395-b8a4-4862-8baa-59307def0105 16714-725 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20170615 ANDA ANDA077219 NorthStar RxLLC IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 16714-726_79f87395-b8a4-4862-8baa-59307def0105 16714-726 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20170615 ANDA ANDA077219 NorthStar RxLLC IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 16714-727_433eaccc-94fa-4369-9043-1a120c9faeba 16714-727 HUMAN PRESCRIPTION DRUG oxaliplatin oxaliplatin INJECTION INTRAVENOUS 20170615 ANDA ANDA208523 NorthStar RxLLC OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 16714-728_433eaccc-94fa-4369-9043-1a120c9faeba 16714-728 HUMAN PRESCRIPTION DRUG oxaliplatin oxaliplatin INJECTION INTRAVENOUS 20170615 ANDA ANDA208523 NorthStar RxLLC OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 16714-729_3127629e-9cf0-442d-895f-38d504c2794c 16714-729 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 19920630 ANDA ANDA073548 NORTHSTAR RX LLC DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16714-730_3fbe81a8-c24b-4be8-b8d5-badabe7d8b9c 16714-730 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate CREAM TOPICAL 19960930 ANDA ANDA074392 Northstar RxLLC CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16714-731_1c3c7bab-60c7-4cbf-81b1-e0c22aedfcf7 16714-731 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20170926 ANDA ANDA207446 NorthStar RxLLC CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 16714-732_1c3c7bab-60c7-4cbf-81b1-e0c22aedfcf7 16714-732 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20170926 ANDA ANDA207446 NorthStar RxLLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 16714-733_1c3c7bab-60c7-4cbf-81b1-e0c22aedfcf7 16714-733 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20170926 ANDA ANDA207446 NorthStar RxLLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 16714-734_1c3c7bab-60c7-4cbf-81b1-e0c22aedfcf7 16714-734 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20170926 ANDA ANDA207446 NorthStar RxLLC CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 16714-735_03ddda6d-2ac0-42d3-a329-7e8f05ee9b22 16714-735 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20170814 ANDA ANDA205606 NorthStar Rx LLC ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 16714-736_03ddda6d-2ac0-42d3-a329-7e8f05ee9b22 16714-736 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20170814 ANDA ANDA205606 NorthStar Rx LLC ESOMEPRAZOLE MAGNESIUM DIHYDRATE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 16714-737_5a95677e-61cd-45c4-8794-c1607e763750 16714-737 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, COATED ORAL 20170715 ANDA ANDA205118 NorthStar Rx LLC FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 16714-738_5a95677e-61cd-45c4-8794-c1607e763750 16714-738 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, COATED ORAL 20170715 ANDA ANDA205118 NorthStar Rx LLC FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 16714-739_e1a8b525-4cd7-47a3-9bfa-42834213df2a 16714-739 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20170821 ANDA ANDA207378 Northstar Rx LLC FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 16714-740_e1a8b525-4cd7-47a3-9bfa-42834213df2a 16714-740 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20170821 ANDA ANDA207378 Northstar Rx LLC FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 16714-741_e1a8b525-4cd7-47a3-9bfa-42834213df2a 16714-741 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20170821 ANDA ANDA207378 Northstar Rx LLC FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 16714-742_fcabd5d9-f64f-288d-a079-56f9c8a34d92 16714-742 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL INTRAVENOUS 20170829 ANDA ANDA208657 NorthStar RxLLC DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 16714-743_67e778c6-d9c9-4c13-8213-462855f19f14 16714-743 HUMAN PRESCRIPTION DRUG Itraconazole Itraconazole CAPSULE, COATED PELLETS ORAL 20170901 ANDA ANDA208591 NorthStar RxLLC ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 16714-746_36341291-2d76-47e6-9d61-194ba7f9bd5a 16714-746 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150819 ANDA ANDA203270 NorthStar Rx LLC OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 16714-747_36341291-2d76-47e6-9d61-194ba7f9bd5a 16714-747 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150819 ANDA ANDA203270 NorthStar Rx LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 16714-748_36341291-2d76-47e6-9d61-194ba7f9bd5a 16714-748 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150819 ANDA ANDA203270 NorthStar Rx LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 16714-749_ff2f613b-a351-4ab0-a750-132eeeb44e42 16714-749 HUMAN PRESCRIPTION DRUG Decitabine Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171120 ANDA ANDA208601 NorthStar RxLLC DECITABINE 50 mg/20mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 16714-750_ee847314-510d-44d5-90bb-7be0c81724d6 16714-750 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20160701 ANDA ANDA074979 Northstar RxLLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 16714-751_ee847314-510d-44d5-90bb-7be0c81724d6 16714-751 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20160701 ANDA ANDA074979 Northstar RxLLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 16714-752_ee847314-510d-44d5-90bb-7be0c81724d6 16714-752 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20160701 ANDA ANDA074979 Northstar RxLLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 16714-856_fcabd5d9-f64f-288d-a079-56f9c8a34d92 16714-856 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL INTRAVENOUS 20170829 ANDA ANDA208657 NorthStar RxLLC DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 16729-001_4e172a95-c132-26bf-e054-00144ff88e88 16729-001 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Accord Healthcare Inc GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 16729-002_4e172a95-c132-26bf-e054-00144ff88e88 16729-002 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Accord Healthcare Inc GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 16729-003_4e172a95-c132-26bf-e054-00144ff88e88 16729-003 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Accord Healthcare Inc GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 16729-004_1b114b57-79ea-0e06-e054-00144ff88e88 16729-004 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Accord Healthcare, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-005_1b114b57-79ea-0e06-e054-00144ff88e88 16729-005 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Accord Healthcare, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-006_1b114b57-79ea-0e06-e054-00144ff88e88 16729-006 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Accord Healthcare, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-007_1b114b57-79ea-0e06-e054-00144ff88e88 16729-007 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Accord Healthcare, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-008_487031ba-4f7b-2c1b-e054-00144ff88e88 16729-008 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170216 ANDA ANDA207068 Accord Healthcare Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-009_487031ba-4f7b-2c1b-e054-00144ff88e88 16729-009 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170216 ANDA ANDA207068 Accord Healthcare Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-010_487031ba-4f7b-2c1b-e054-00144ff88e88 16729-010 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170216 ANDA ANDA207068 Accord Healthcare Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-011_487031ba-4f7b-2c1b-e054-00144ff88e88 16729-011 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170216 ANDA ANDA207068 Accord Healthcare Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-019_26692c61-433b-5687-e054-00144ff8d46c 16729-019 HUMAN PRESCRIPTION DRUG mycophenolate mofetil mycophenolate mofetil TABLET ORAL 20090504 ANDA ANDA065416 Accord Healthcare Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 16729-020_614ff999-b7db-a078-e053-2a91aa0abc47 16729-020 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 Accord Healthcare, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 16729-021_614ff999-b7db-a078-e053-2a91aa0abc47 16729-021 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 Accord Healthcare, Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 16729-022_614ff999-b7db-a078-e053-2a91aa0abc47 16729-022 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 Accord Healthcare, Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 16729-023_55d6f57d-a2a8-301c-e054-00144ff88e88 16729-023 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET ORAL 20090706 ANDA ANDA078917 Accord Healthcare Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 16729-030_2603652f-8a49-3eb3-e054-00144ff8d46c 16729-030 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20120724 ANDA ANDA070084 Accord Healthcare Inc. METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 16729-031_2603652f-8a49-3eb3-e054-00144ff8d46c 16729-031 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20120724 ANDA ANDA070085 Accord Healthcare Inc. METHYLDOPA 500 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 16729-034_25fceda8-757c-1fc7-e054-00144ff8d46c 16729-034 HUMAN PRESCRIPTION DRUG Letrozole letrozole TABLET, FILM COATED ORAL 20110602 ANDA ANDA090934 Accord Healthcare, Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 16729-035_5a90447a-38a1-6919-e053-2991aa0a3f17 16729-035 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100622 ANDA ANDA090568 Accord Healthcare Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 16729-041_2e518b1e-dbf3-2f6c-e054-00144ff88e88 16729-041 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20110930 ANDA ANDA091195 Accord Healthcare Inc. TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 16729-042_2e518b1e-dbf3-2f6c-e054-00144ff88e88 16729-042 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20110930 ANDA ANDA091195 Accord Healthcare Inc. TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 16729-043_2e518b1e-dbf3-2f6c-e054-00144ff88e88 16729-043 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20110930 ANDA ANDA091195 Accord Healthcare Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 16729-048_51f0239b-76b7-04f6-e054-00144ff8d46c 16729-048 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170307 ANDA ANDA201528 Accord Healthcare Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 16729-049_51f0239b-76b7-04f6-e054-00144ff8d46c 16729-049 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170307 ANDA ANDA201528 Accord Healthcare Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 16729-050_51f0239b-76b7-04f6-e054-00144ff8d46c 16729-050 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170307 ANDA ANDA201528 Accord Healthcare Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 16729-051_51f0239b-76b7-04f6-e054-00144ff8d46c 16729-051 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170307 ANDA ANDA201528 Accord Healthcare Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 16729-064_58e60eab-098c-1f8d-e053-2a91aa0aeedc 16729-064 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20130523 ANDA ANDA090843 Accord Healthcare Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16729-065_58e60eab-098c-1f8d-e053-2a91aa0aeedc 16729-065 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20130531 ANDA ANDA090843 Accord Healthcare Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16729-066_58e60eab-098c-1f8d-e053-2a91aa0aeedc 16729-066 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20130523 ANDA ANDA090843 Accord Healthcare Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16729-067_58e60eab-098c-1f8d-e053-2a91aa0aeedc 16729-067 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20130531 ANDA ANDA090843 Accord Healthcare Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 16729-072_4ab4c460-f4b8-0b29-e054-00144ff8d46c 16729-072 HUMAN PRESCRIPTION DRUG CAPECITABINE CAPECITABINE TABLET, FILM COATED ORAL 20150609 ANDA ANDA202593 Accord Healthcare Inc. CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 16729-073_4ab4c460-f4b8-0b29-e054-00144ff8d46c 16729-073 HUMAN PRESCRIPTION DRUG CAPECITABINE CAPECITABINE TABLET, FILM COATED ORAL 20150520 ANDA ANDA202593 Accord Healthcare Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 16729-078_255083ad-2323-2d3e-e054-00144ff88e88 16729-078 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20130613 ANDA ANDA202323 Accord Healthcare, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 16729-079_255083ad-2323-2d3e-e054-00144ff88e88 16729-079 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20130613 ANDA ANDA202323 Accord Healthcare, Inc. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 16729-081_4809b267-b0d6-4588-e054-00144ff88e88 16729-081 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20120118 ANDA ANDA091205 Accord Healthcare, Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 16729-089_39dc82ab-9d95-6a7c-e054-00144ff88e88 16729-089 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20131108 ANDA ANDA091643 Accord Healthcare, Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 16729-090_42b255b2-aef5-316e-e054-00144ff8d46c 16729-090 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20100528 ANDA ANDA090121 Accord Healthcare, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 16729-092_3d320325-0b88-4a83-e054-00144ff8d46c 16729-092 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110728 ANDA ANDA091594 Accord Healthcare Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 16729-094_26692c61-433b-5687-e054-00144ff8d46c 16729-094 HUMAN PRESCRIPTION DRUG mycophenolate mofetil mycophenolate mofetil CAPSULE ORAL 20090504 ANDA ANDA090253 Accord Healthcare Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 16729-095_504be875-0543-5871-e054-00144ff88e88 16729-095 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170522 ANDA ANDA090681 Accord Healthcare Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-096_504be875-0543-5871-e054-00144ff88e88 16729-096 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170522 ANDA ANDA090681 Accord Healthcare Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-097_504be875-0543-5871-e054-00144ff88e88 16729-097 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20161101 ANDA ANDA090681 Accord Healthcare Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-108_0a4ea340-dcd4-2b02-e054-00144ff88e88 16729-108 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090610 ANDA ANDA064144 Accord Healthcare Inc MITOMYCIN 20 mg/40mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 16729-109_504be875-0543-5871-e054-00144ff88e88 16729-109 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170523 ANDA ANDA090681 Accord Healthcare Inc. QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-114_5b5fb93c-86f2-b007-e053-2991aa0ad683 16729-114 HUMAN PRESCRIPTION DRUG Etoposide Etoposide INJECTION INTRAVENOUS 20150303 ANDA ANDA074513 Accord Healthcare Inc. ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 16729-115_0a4ea340-dcd4-2b02-e054-00144ff88e88 16729-115 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090618 ANDA ANDA064144 Accord Healthcare Inc MITOMYCIN 5 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 16729-116_0a4ea340-dcd4-2b02-e054-00144ff88e88 16729-116 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110311 ANDA ANDA064144 Accord Healthcare Inc MITOMYCIN 40 mg/80mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 16729-117_3d320325-0b88-4a83-e054-00144ff8d46c 16729-117 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110801 ANDA ANDA091594 Accord Healthcare Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 16729-118_3d320325-0b88-4a83-e054-00144ff8d46c 16729-118 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110831 ANDA ANDA091594 Accord Healthcare Inc. GEMCITABINE HYDROCHLORIDE 2 g/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 16729-119_4e1732d7-ec10-1839-e054-00144ff88e88 16729-119 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20130411 ANDA ANDA202717 Accord Healthcare Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 16729-120_4b7f22ab-2e31-0695-e054-00144ff88e88 16729-120 HUMAN PRESCRIPTION DRUG DOCETAXEL docetaxel KIT 20110630 NDA NDA201195 Accord Healthcare Inc. N 20181231 16729-129_51f0239b-76b7-04f6-e054-00144ff8d46c 16729-129 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170307 ANDA ANDA201528 Accord Healthcare Inc. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 16729-130_51f0239b-76b7-04f6-e054-00144ff8d46c 16729-130 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170307 ANDA ANDA201528 Accord Healthcare Inc. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 16729-132_5f4a2428-1ea0-d9e1-e053-2a91aa0a2ede 16729-132 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20171130 ANDA ANDA206252 Accord Healthcare Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-134_4761bc73-9bd6-6e74-e054-00144ff8d46c 16729-134 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20150429 ANDA ANDA203154 Accord Healthcare Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 16729-135_4761bc73-9bd6-6e74-e054-00144ff8d46c 16729-135 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20150429 ANDA ANDA203154 Accord Healthcare Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 16729-136_5aa32c43-0d11-388c-e053-2991aa0ac54c 16729-136 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 Accord Healthcare Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 16729-137_5aa32c43-0d11-388c-e053-2991aa0ac54c 16729-137 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 Accord Healthcare Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 16729-138_5aa32c43-0d11-388c-e053-2991aa0ac54c 16729-138 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 Accord Healthcare Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 16729-139_4bbb949b-bcca-2868-e054-00144ff88e88 16729-139 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 Accord Healthcare Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 16729-140_4bbb949b-bcca-2868-e054-00144ff88e88 16729-140 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 Accord Healthcare Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 16729-141_53151727-c698-579a-e054-00144ff8d46c 16729-141 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 20170410 ANDA ANDA202873 Accord Healthcare Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-142_53151727-c698-579a-e054-00144ff8d46c 16729-142 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 20170410 ANDA ANDA202873 Accord Healthcare Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-145_53151727-c68c-579a-e054-00144ff8d46c 16729-145 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 Accord Healthcare Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-146_53151727-c68c-579a-e054-00144ff8d46c 16729-146 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 Accord Healthcare Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-147_53151727-c68c-579a-e054-00144ff8d46c 16729-147 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 Accord Healthcare Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-148_53151727-c68c-579a-e054-00144ff8d46c 16729-148 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 Accord Healthcare Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-149_53151727-c68c-579a-e054-00144ff8d46c 16729-149 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 Accord Healthcare Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-150_53151727-c68c-579a-e054-00144ff8d46c 16729-150 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 Accord Healthcare Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-151_256208d7-142f-6105-e054-00144ff88e88 16729-151 HUMAN PRESCRIPTION DRUG topotecan hydrochloride topotecan hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130723 ANDA ANDA202351 Accord Healthcare, Inc. TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 16729-152_3653d3cf-129c-2503-e054-00144ff8d46c 16729-152 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20150212 ANDA ANDA202392 Accord Healthcare Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16729-153_3653d3cf-129c-2503-e054-00144ff8d46c 16729-153 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20150212 ANDA ANDA202392 Accord Healthcare Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16729-154_3653d3cf-129c-2503-e054-00144ff8d46c 16729-154 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20150212 ANDA ANDA202392 Accord Healthcare Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16729-155_3653d3cf-129c-2503-e054-00144ff8d46c 16729-155 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20150212 ANDA ANDA202392 Accord Healthcare Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16729-156_1b114b57-79ea-0e06-e054-00144ff88e88 16729-156 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20130902 ANDA ANDA078155 Accord Healthcare, Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-168_25595ae2-95da-1be6-e054-00144ff88e88 16729-168 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130305 ANDA ANDA202389 Accord Healthcare Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16729-169_25595ae2-95da-1be6-e054-00144ff88e88 16729-169 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130319 ANDA ANDA202389 Accord Healthcare Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16729-170_25595ae2-95da-1be6-e054-00144ff88e88 16729-170 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130321 ANDA ANDA202389 Accord Healthcare Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16729-171_4789e8da-00c8-6896-e054-00144ff8d46c 16729-171 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Accord Healthcare Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 16729-172_4789e8da-00c8-6896-e054-00144ff8d46c 16729-172 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Accord Healthcare Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 16729-173_4789e8da-00c8-6896-e054-00144ff8d46c 16729-173 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Accord Healthcare Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 16729-174_4789e8da-00c8-6896-e054-00144ff8d46c 16729-174 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141226 ANDA ANDA202446 Accord Healthcare Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 16729-175_4789e8da-00c8-6896-e054-00144ff8d46c 16729-175 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Accord Healthcare Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 16729-176_4789e8da-00c8-6896-e054-00144ff8d46c 16729-176 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141226 ANDA ANDA202446 Accord Healthcare Inc. AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 16729-182_2818d0da-c95b-5cc9-e054-00144ff88e88 16729-182 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130418 ANDA ANDA202556 Accord Healthcare Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 16729-183_2818d0da-c95b-5cc9-e054-00144ff88e88 16729-183 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 Accord Healthcare Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 16729-184_2818d0da-c95b-5cc9-e054-00144ff88e88 16729-184 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 Accord Healthcare Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 16729-189_5902a650-722c-3c98-e053-2a91aa0a9549 16729-189 HUMAN PRESCRIPTION DRUG Mycophenolic Acid Mycophenolic Acid TABLET, DELAYED RELEASE ORAL 20170911 ANDA ANDA202555 Accord Healthcare Inc. MYCOPHENOLATE SODIUM 360 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 16729-200_4e184b68-3259-57d3-e054-00144ff88e88 16729-200 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161215 ANDA ANDA202557 Accord Healthcare Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 16729-201_4e184b68-3259-57d3-e054-00144ff88e88 16729-201 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161114 ANDA ANDA202557 Accord Healthcare Inc. BUSPIRONE HYDROCHLORIDE 7.5 mg/1 N 20181231 16729-202_4e184b68-3259-57d3-e054-00144ff88e88 16729-202 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161215 ANDA ANDA202557 Accord Healthcare Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 16729-203_4e184b68-3259-57d3-e054-00144ff88e88 16729-203 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161215 ANDA ANDA202557 Accord Healthcare Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 16729-211_544d549e-a6f3-24a5-e054-00144ff8d46c 16729-211 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150304 ANDA ANDA202824 Accord Healthcare Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 16729-212_544d549e-a6f3-24a5-e054-00144ff8d46c 16729-212 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150429 20181031 ANDA ANDA202824 Accord Healthcare Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 16729-213_544d549e-a6f3-24a5-e054-00144ff8d46c 16729-213 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150422 ANDA ANDA202824 Accord Healthcare Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 16729-214_544d549e-a6f3-24a5-e054-00144ff8d46c 16729-214 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150429 20190131 ANDA ANDA202824 Accord Healthcare Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 16729-215_4aac89bf-439b-3ba9-e054-00144ff8d46c 16729-215 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170209 ANDA ANDA202825 Accord Healthcare, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16729-216_4aac89bf-439b-3ba9-e054-00144ff8d46c 16729-216 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170209 ANDA ANDA202825 Accord Healthcare, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16729-217_4aac89bf-439b-3ba9-e054-00144ff8d46c 16729-217 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170209 ANDA ANDA202825 Accord Healthcare, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 16729-218_4e180cd5-2fd7-5047-e054-00144ff88e88 16729-218 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel bisulphate TABLET, FILM COATED ORAL 20131121 ANDA ANDA202925 Accord Healthcare Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 16729-219_4e180cd5-2fd7-5047-e054-00144ff88e88 16729-219 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel bisulphate TABLET, FILM COATED ORAL 20150108 ANDA ANDA202925 Accord Healthcare Inc. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 16729-224_4a4fdf61-c80b-06db-e054-00144ff88e88 16729-224 HUMAN PRESCRIPTION DRUG Decitabine decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170308 ANDA ANDA203475 Accord Healthcare Inc. DECITABINE 50 mg/20mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 16729-225_5218bee2-0b78-42ce-e054-00144ff8d46c 16729-225 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170602 ANDA ANDA203512 Accord Healthcare, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 16729-226_5218bee2-0b78-42ce-e054-00144ff8d46c 16729-226 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170602 ANDA ANDA203512 Accord Healthcare, Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 16729-227_5218bee2-0b78-42ce-e054-00144ff8d46c 16729-227 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170602 ANDA ANDA203512 Accord Healthcare, Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 16729-228_4b7f22ab-2e31-0695-e054-00144ff88e88 16729-228 HUMAN PRESCRIPTION DRUG DOCETAXEL docetaxel KIT 20110630 NDA NDA201195 Accord Healthcare Inc. N 20181231 16729-231_4b7f22ab-2e31-0695-e054-00144ff88e88 16729-231 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20120701 NDA NDA201195 Accord Healthcare Inc. DOCETAXEL ANHYDROUS 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 16729-239_4e189a51-7716-6122-e054-00144ff88e88 16729-239 HUMAN PRESCRIPTION DRUG Dexmedetomidine hydrochloride Dexmedetomidine hydrochloride INJECTION, SOLUTION INTRAVENOUS 20161221 ANDA ANDA204023 Accord Healthcare Inc. DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 16729-242_5bc218fb-afc8-08ef-e053-2991aa0a01c2 16729-242 HUMAN PRESCRIPTION DRUG Zoledronic acid Zoledronic acid INJECTION INTRAVENOUS 20171016 ANDA ANDA205279 Accord Healthcare Inc. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 16729-246_f3041806-e608-47e0-89ae-3f4125c9ccfe 16729-246 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130503 ANDA ANDA064144 Accord Healthcare Inc MITOMYCIN 5 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 16729-247_e40c2556-f14f-4dc1-a152-89d584dc9ff9 16729-247 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130503 ANDA ANDA064144 Accord Healthcare Inc MITOMYCIN 20 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 16729-248_e40c2556-f14f-4dc1-a152-89d584dc9ff9 16729-248 HUMAN PRESCRIPTION DRUG Mitomycin Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130503 ANDA ANDA064144 Accord Healthcare Inc MITOMYCIN 40 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 16729-252_58f95c88-fece-9d32-e053-2991aa0a53b2 16729-252 HUMAN PRESCRIPTION DRUG Esomeprazole sodium Esomeprazole sodium INJECTION INTRAVENOUS 20161011 ANDA ANDA205379 Accord Healthcare Inc. ESOMEPRAZOLE SODIUM 40 mg/5mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 16729-261_5902a650-722c-3c98-e053-2a91aa0a9549 16729-261 HUMAN PRESCRIPTION DRUG Mycophenolic Acid Mycophenolic Acid TABLET, DELAYED RELEASE ORAL 20170911 ANDA ANDA202555 Accord Healthcare Inc. MYCOPHENOLATE SODIUM 180 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 16729-262_5b5fc65e-1c07-c059-e053-2991aa0ac3ce 16729-262 HUMAN PRESCRIPTION DRUG Etoposide Etoposide INJECTION INTRAVENOUS 20130822 ANDA ANDA074513 Accord Healthcare Inc. ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 16729-267_4b7f22ab-2e31-0695-e054-00144ff88e88 16729-267 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130530 NDA NDA201195 Accord Healthcare Inc. DOCETAXEL ANHYDROUS 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 16729-271_5494da08-60a4-4a1e-e054-00144ff88e88 16729-271 HUMAN PRESCRIPTION DRUG Itraconazole ITRACONAZOLE CAPSULE ORAL 20170530 ANDA ANDA205991 Accord Healthcare Inc. ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 16729-276_492ff0cd-24fe-0b4d-e054-00144ff8d46c 16729-276 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20140314 ANDA ANDA040743 Accord Healthcare, Inc. FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 16729-276_4930358c-89ed-1ac5-e054-00144ff88e88 16729-276 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20140314 ANDA ANDA040798 Accord Healthcare, Inc. FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 16729-277_ffb66c4a-52b1-4088-9a69-2a2cf2437a1c 16729-277 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20140201 ANDA ANDA040716 Accord Healthcare, Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 16729-278_5316a0a5-4f2d-62d1-e054-00144ff88e88 16729-278 HUMAN PRESCRIPTION DRUG ARIPIPRAZOLE ARIPIPRAZOLE TABLET ORAL 20170215 ANDA ANDA206251 Accord Healthcare, Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-279_5316a0a5-4f2d-62d1-e054-00144ff88e88 16729-279 HUMAN PRESCRIPTION DRUG ARIPIPRAZOLE ARIPIPRAZOLE TABLET ORAL 20170215 ANDA ANDA206251 Accord Healthcare, Inc. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-280_5316a0a5-4f2d-62d1-e054-00144ff88e88 16729-280 HUMAN PRESCRIPTION DRUG ARIPIPRAZOLE ARIPIPRAZOLE TABLET ORAL 20170215 ANDA ANDA206251 Accord Healthcare, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-281_5316a0a5-4f2d-62d1-e054-00144ff88e88 16729-281 HUMAN PRESCRIPTION DRUG ARIPIPRAZOLE ARIPIPRAZOLE TABLET ORAL 20170215 ANDA ANDA206251 Accord Healthcare, Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-282_5316a0a5-4f2d-62d1-e054-00144ff88e88 16729-282 HUMAN PRESCRIPTION DRUG ARIPIPRAZOLE ARIPIPRAZOLE TABLET ORAL 20170215 ANDA ANDA206251 Accord Healthcare, Inc. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-283_5316a0a5-4f2d-62d1-e054-00144ff88e88 16729-283 HUMAN PRESCRIPTION DRUG ARIPIPRAZOLE ARIPIPRAZOLE TABLET ORAL 20170214 ANDA ANDA206251 Accord Healthcare, Inc. ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 16729-284_479f524a-aa26-014c-e054-00144ff8d46c 16729-284 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA206434 Accord Healthcare Inc. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-285_479f524a-aa26-014c-e054-00144ff8d46c 16729-285 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA206434 Accord Healthcare Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-286_479f524a-aa26-014c-e054-00144ff8d46c 16729-286 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA206434 Accord Healthcare Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-287_479f524a-aa26-014c-e054-00144ff8d46c 16729-287 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA206434 Accord Healthcare Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 16729-288_43a22af4-12fc-640e-e054-00144ff88e88 16729-288 HUMAN PRESCRIPTION DRUG Cisplatin Cisplatin INJECTION INTRAVENOUS 20161213 ANDA ANDA206774 Accord Healthcare, Inc. CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 16729-289_4e184b68-3259-57d3-e054-00144ff88e88 16729-289 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161215 ANDA ANDA202557 Accord Healthcare Inc. BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 16729-295_5bc235d3-c303-2710-e053-2991aa0a73cb 16729-295 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION INTRAVENOUS 20170919 ANDA ANDA206775 Accord Healthcare, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 16729-297_5cde1c5b-73dc-0687-e053-2a91aa0ac737 16729-297 HUMAN PRESCRIPTION DRUG ondansetron ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20161020 ANDA ANDA206845 Accord Healthcare, Inc. ONDANSETRON 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 16729-298_58fbdc1b-69f5-58f3-e053-2991aa0a1a04 16729-298 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20161020 ANDA ANDA206846 Accord Healthcare, Inc. ONDANSETRON 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 16729-310_3c739fb5-1736-7263-e054-00144ff88e88 16729-310 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION, SOLUTION INTRAVENOUS 20160324 NDA NDA207174 Accord Healthcare, Inc. PARICALCITOL 2 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 16729-311_3c739fb5-1736-7263-e054-00144ff88e88 16729-311 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION, SOLUTION INTRAVENOUS 20160324 NDA NDA207174 Accord Healthcare, Inc. PARICALCITOL 5 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 16729-317_4d77d95f-b747-56f6-e054-00144ff88e88 16729-317 HUMAN PRESCRIPTION DRUG oxybutynin chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20161214 ANDA ANDA207138 Accord Healthcare, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 16729-318_4d77d95f-b747-56f6-e054-00144ff88e88 16729-318 HUMAN PRESCRIPTION DRUG oxybutynin chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20161220 ANDA ANDA207138 Accord Healthcare, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 16729-319_4d77d95f-b747-56f6-e054-00144ff88e88 16729-319 HUMAN PRESCRIPTION DRUG oxybutynin chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20161214 ANDA ANDA207138 Accord Healthcare, Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 16729-321_62df1bcf-010a-9e76-e053-2991aa0a566a 16729-321 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20170427 ANDA ANDA207662 Accord Healthcare Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 16729-322_62df1bcf-010a-9e76-e053-2991aa0a566a 16729-322 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20170427 ANDA ANDA207662 Accord Healthcare Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 16729-375_44a8337d-ed3c-5372-e054-00144ff8d46c 16729-375 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20161222 ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16729-376_44a8337d-ed3c-5372-e054-00144ff8d46c 16729-376 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160602 ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16729-377_44a8337d-ed3c-5372-e054-00144ff8d46c 16729-377 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160425 ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16729-378_44a8337d-ed3c-5372-e054-00144ff8d46c 16729-378 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160427 ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16729-379_44a8337d-ed3c-5372-e054-00144ff8d46c 16729-379 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160520 ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16729-380_44a8337d-ed3c-5372-e054-00144ff8d46c 16729-380 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160429 ANDA ANDA202554 Accord Healthcare Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 16729-391_63f89a24-a098-ecbc-e053-2991aa0ac7d7 16729-391 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE INJECTION, SOLUTION INTRAVENOUS 20180124 NDA NDA209604 Accord Healthcare Inc. GEMCITABINE HYDROCHLORIDE 100 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 16729-414_544d549e-a6f3-24a5-e054-00144ff8d46c 16729-414 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20170614 ANDA ANDA202824 Accord Healthcare Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 16729-415_544d549e-a6f3-24a5-e054-00144ff8d46c 16729-415 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20170710 ANDA ANDA202824 Accord Healthcare Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 16729-419_63f89a24-a098-ecbc-e053-2991aa0ac7d7 16729-419 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE INJECTION, SOLUTION INTRAVENOUS 20180125 NDA NDA209604 Accord Healthcare Inc. GEMCITABINE HYDROCHLORIDE 100 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 16729-423_63f89a24-a098-ecbc-e053-2991aa0ac7d7 16729-423 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE INJECTION, SOLUTION INTRAVENOUS 20180124 NDA NDA209604 Accord Healthcare Inc. GEMCITABINE HYDROCHLORIDE 100 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 16781-382_6ec92ef0-61f0-4aa6-b5d8-8afa39e47b84 16781-382 HUMAN PRESCRIPTION DRUG Locoid HYDROCORTISONE BUTYRATE CREAM TOPICAL 20130703 NDA NDA018514 Onset Dermatologics, LLC HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16781-384_b57e27d2-8476-4b8d-b2db-bfffd94f1e56 16781-384 HUMAN PRESCRIPTION DRUG Locoid Lipocream HYDROCORTISONE BUTYRATE CREAM TOPICAL 20130703 NDA NDA020769 Onset Dermatologics LLC HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16781-389_9538de88-fd0d-4b6d-882b-072c2f7176cf 16781-389 HUMAN PRESCRIPTION DRUG Locoid HYDROCORTISONE BUTYRATE OINTMENT TOPICAL 20130708 NDA NDA018652 Onset Dermatologics, LLC HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16781-391_d5a2110e-af28-40e3-b91f-f543c49f296e 16781-391 HUMAN PRESCRIPTION DRUG Locoid HYDROCORTISONE BUTYRATE SOLUTION TOPICAL 20130702 NDA NDA019116 Onset Dermatologics, LLC HYDROCORTISONE BUTYRATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16781-392_bca0bcaf-9267-4f19-a52c-478464f55b88 16781-392 HUMAN PRESCRIPTION DRUG Locoid HYDROCORTISONE BUTYRATE LOTION TOPICAL 20130703 NDA NDA022076 Onset Dermatologics, LLC HYDROCORTISONE BUTYRATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 16781-400_a763020c-de64-42c1-babd-dd00d35fd75f 16781-400 HUMAN PRESCRIPTION DRUG Minocin minocycline hydrochloride CAPSULE, COATED PELLETS ORAL 19900531 NDA NDA050649 Onset Dermatologics LLC MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 16781-403_a763020c-de64-42c1-babd-dd00d35fd75f 16781-403 HUMAN PRESCRIPTION DRUG Minocin minocycline hydrochloride CAPSULE, COATED PELLETS ORAL 19900531 NDA NDA050649 Onset Dermatologics LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 16781-462_862e8a7c-5be8-439e-a12f-59899681ddc1 16781-462 HUMAN PRESCRIPTION DRUG Clindagel CLINDAMYCIN GEL TOPICAL 20131125 NDA NDA050782 Onset Dermatologics LLC CLINDAMYCIN PHOSPHATE 1 g/10mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 16837-246_c0b84245-f164-4229-bacd-af4784e31141 16837-246 HUMAN OTC DRUG Pepcid Complete Famotidine, Calcium Carbonate, and Magnesium Hydroxide TABLET, CHEWABLE ORAL 20090101 NDA NDA020958 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 16837-298_854fcf06-9eb2-4505-938e-aa4f8c693f27 16837-298 HUMAN OTC DRUG Pepcid Complete Famotidine, Calcium carbonate, and Magnesium hydroxide TABLET, CHEWABLE ORAL 20090301 NDA NDA020958 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 16837-855_29dbfeab-5d96-493c-ad99-69f30a6c8133 16837-855 HUMAN OTC DRUG PEPCID AC Maximum Strength Famotidine TABLET, FILM COATED ORAL 20030901 NDA NDA020325 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division FAMOTIDINE 20 mg/1 N 20181231 16837-872_e0029bf5-7921-43d5-8ddb-c84b2e17a93b 16837-872 HUMAN OTC DRUG Pepcid AC Original Strength Famotidine TABLET, FILM COATED ORAL 19951001 NDA NDA020325 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division FAMOTIDINE 10 mg/1 N 20181231 16837-891_0b479778-0ecb-4ccb-8986-5527dfe34ff9 16837-891 HUMAN OTC DRUG Pepcid Complete famotidine, calcium carbonate, and magnesium hydroxide TABLET, CHEWABLE ORAL 20090301 NDA NDA020958 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 16853-1261_110b051e-8123-4443-b9c3-9e3181a528b2 16853-1261 HUMAN OTC DRUG ALLEROFF Cetirizine Hydrochloride SYRUP ORAL 20100115 NDA NDA022155 Corporacion Infarmasa CETIRIZINE HYDROCHLORIDE 1 mg/1 E 20171231 16853-1305_98661a3c-c95c-4ab1-b62f-87dde7f88296 16853-1305 HUMAN OTC DRUG ALLEROFF Cetirizine Hydrochloride TABLET ORAL 20100101 NDA NDA019835 Corporacion Infarmasa CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 16853-1307_bdd5bed7-9c23-4457-87ab-cfefadfc97bb 16853-1307 HUMAN OTC DRUG ALLEROFF Cetirizine Hydrochloride TABLET ORAL 20100101 NDA NDA019835 Corporacion Infarmasa CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 16853-1308_b16d55b9-70a2-4734-a8f4-bfd1cd108be4 16853-1308 HUMAN OTC DRUG OMESEC Omeprazole CAPSULE, DELAYED RELEASE ORAL 20100228 ANDA ANDA075410 Corporacion Infarmasa OMEPRAZOLE 20 mg/1 E 20171231 16864-001_2bc82f49-c7a0-d1c4-31c6-ba313010212d 16864-001 HUMAN OTC DRUG JointFlex Camphor CREAM TOPICAL 20100416 OTC MONOGRAPH NOT FINAL part348 MOBERG PHARMA NORTH AMERICA LLC CAMPHOR (SYNTHETIC) 3.58 g/114g N 20181231 16864-182_c7c1965c-544c-43d3-ab98-4a4c7acc33ad 16864-182 HUMAN OTC DRUG Kerasal foot and toe Clotrimazole CREAM TOPICAL 20150101 20180531 OTC MONOGRAPH FINAL part333C MOBERG PHARMA NORTH AMERICA LLC CLOTRIMAZOLE 1 g/100g N 20191231 16864-192_c35846dd-56f7-9d77-fbac-91cbac5db673 16864-192 HUMAN OTC DRUG Domeboro Cooling Aluminum Acetate GEL TOPICAL 20160301 OTC MONOGRAPH FINAL part347 MOBERG PHARMA NORTH AMERICA LLC ALUMINUM ACETATE 5 mg/mL N 20181231 16864-201_bbd8b2c5-332a-488b-90e2-1a8bfedeb314 16864-201 HUMAN OTC DRUG Vanquish Acetaminophen, Aspirin, and Caffeine TABLET, COATED ORAL 20120626 20180430 OTC MONOGRAPH NOT FINAL part343 MOBERG PHARMA NORTH AMERICA LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 194; 227; 33 mg/1; mg/1; mg/1 N 20191231 16864-240_5b6f3901-82fb-4b7e-9ee4-34f8eb6db483 16864-240 HUMAN OTC DRUG Domeboro Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate POWDER, FOR SOLUTION TOPICAL 20120626 OTC MONOGRAPH NOT FINAL part347 MOBERG PHARMA NORTH AMERICA LLC ALUMINUM SULFATE TETRADECAHYDRATE; CALCIUM ACETATE MONOHYDRATE 1347; 952 mg/1; mg/1 N 20191231 16864-440_d9c47123-924a-4373-8639-9ebe90310000 16864-440 HUMAN OTC DRUG New Skin Bandage Benzethonium Chloride LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333A Moberg Pharma North America LLC BENZETHONIUM CHLORIDE 1.8 mg/mL N 20181231 16864-450_4c028c0b-29b5-498b-80bf-66b05358d52e 16864-450 HUMAN OTC DRUG New Skin Bandage Benzethonium Chloride SPRAY TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333A Moberg Pharma North America LLC BENZETHONIUM CHLORIDE 60 mg/g N 20181231 16864-540_db2293a8-3e3f-479b-8f18-bbcc96d4aaf1 16864-540 HUMAN OTC DRUG PediaCare Plus Multisymptom Cold ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20100709 20181231 OTC MONOGRAPH FINAL part341 Moberg Pharma North America LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20191231 16864-670_735c48f9-e2a4-48c5-80a2-3822dc7e301f 16864-670 HUMAN OTC DRUG Dermoplast First Aid BENZETHONIUM CHLORIDE and BENZOCAINE SPRAY TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Moberg Pharma North America LLC BENZETHONIUM CHLORIDE; BENZOCAINE 2; 200 mg/g; mg/g N 20181231 16864-680_2e6b2601-b6ad-47a8-a9d2-3df979e40f18 16864-680 HUMAN OTC DRUG Dermoplast Pain Relieving BENZOCAINE and LEVOMENTHOL SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Moberg Pharma North America LLC BENZOCAINE; LEVOMENTHOL 200; 5 mg/g; mg/g N 20181231 16864-902_db8fe0a5-1aef-432e-abb2-a2f109292009 16864-902 HUMAN OTC DRUG Balmex Adult Care Rash Zinc Oxide CREAM TOPICAL 20150427 OTC MONOGRAPH FINAL part347 MOBERG PHARMA NORTH AMERICA LLC ZINC OXIDE .113 g/g N 20181231 16864-903_99288001-1195-4327-9ef7-dd032bc47a9f 16864-903 HUMAN OTC DRUG Balmex MULTI-PURPOSE Petrolatum OINTMENT TOPICAL 20150427 OTC MONOGRAPH FINAL part347 MOBERG PHARMA NORTH AMERICA LLC PETROLATUM 511 mg/g N 20181231 16864-908_246a9aff-22d2-4500-a4f3-d794a2640306 16864-908 HUMAN OTC DRUG Balmex Diaper Rash Zinc Oxide CREAM TOPICAL 20150427 OTC MONOGRAPH FINAL part347 MOBERG PHARMA NORTH AMERICA LLC ZINC OXIDE .113 g/g N 20181231 16903-168_5d9546ec-9b83-69a6-e053-2a91aa0a4e47 16903-168 HUMAN OTC DRUG Theraderm Pain Relieving Patch Methyl Salicylate Menthol Eucalyptus PATCH TOPICAL 20140605 UNAPPROVED DRUG OTHER Manna Omni International Incorporated MENTHOL; METHYL SALICYLATE; EUCALYPTUS OIL 105; 31.5; 105 1/1; 1/1; 1/1 N 20191231 16903-169_5bb21454-3e98-a063-e053-2a91aa0acc8c 16903-169 HUMAN OTC DRUG TheraDerm METHYL SALICYLATE 2-ETHYLBUTYRATE SPRAY TOPICAL 20170317 UNAPPROVED DRUG OTHER Manna Omni International Incorporated PEPPERMINT OIL; METHYL SALICYLATE 2-ETHYLBUTYRATE; MENTHOL; CAMPHOR OIL 12; 24; 12; 5 mg/120mg; mg/120mg; mg/120mg; mg/120mg N 20181231 16903-170_5a5a8ce6-2c7c-e078-e053-2991aa0a0e3a 16903-170 HUMAN OTC DRUG Thera Derm Methyl Salicylate LOTION TOPICAL 20171031 UNAPPROVED DRUG OTHER Manna Omni International Incorporated 7-AMINODESACETOXYCEPHALOSPORANIC ACID; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 2-ETHYLBUTYRATE; PEPPERMINT OIL; CAMPHOR LEAF OIL 450; 13; 28; 13; 6 mg/240mg; mg/240mg; mg/240mg; mg/240mg; mg/240mg N 20181231 16903-171_5bb204f3-90fc-6dee-e053-2a91aa0a2b55 16903-171 HUMAN OTC DRUG Thera Derm Roll On Methyl Salicylate LIQUID TOPICAL 20170731 UNAPPROVED DRUG OTHER Manna Omni International Incorporated METHYL SALICYLATE 2-ETHYLBUTYRATE; CAMPHOR (NATURAL); PEPPERMINT OIL; MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)- 18; 4; 9; 9 mg/90mg; mg/90mg; mg/90mg; mg/90mg N 20181231 16913-0001_125da24d-ad4f-444f-9590-fd221534d345 16913-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060101 UNAPPROVED MEDICAL GAS Advanced Medical Equipment, LLC OXYGEN 99 L/100L E 20171231 16995-001_e4ff216e-e4a8-4c7e-b752-ce1621eba1b5 16995-001 HUMAN OTC DRUG FLORIL REDNESS RELIEF NAPHAZOLINE HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 20051110 OTC MONOGRAPH FINAL part349 VITALINE S.A.C. NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 20 3; 2 mg/10mL; mg/mL E 20171231 16995-002_6becdef5-06d3-4a24-b46b-c8bb682a1339 16995-002 HUMAN OTC DRUG FLORIL TEARS POLYVINYL ALCOHOL SOLUTION/ DROPS OPHTHALMIC 20051110 OTC MONOGRAPH FINAL part349 VITALINE S.A.C. POLYVINYL ALCOHOL; POLYETHYLENE GLYCOL 400 14; 2 mL/mL; mg/mL E 20171231 16995-004_94f2f212-eba2-47a6-96ac-9f9639e2a09d 16995-004 HUMAN OTC DRUG FLORIL TEARS POLYVINYL ALCOHOL SOLUTION/ DROPS OPHTHALMIC 20051110 OTC MONOGRAPH FINAL part349 VITALINE S.A.C. POLYVINYL ALCOHOL 14 mg/mL E 20171231 17089-025_57313e64-76c2-479b-8fec-ebb81c434a41 17089-025 HUMAN OTC DRUG GUNA-FLU ACONITUM NAPELLUS - ASCLEPIAS CURASSAVICA - ATROPA BELLADONNA - CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - COPPER - ECHINACEA ANGUSTIFOLIA - HAEMOPHILUS INFLUENZAE TYPE B - PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ACONITUM NAPELLUS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ASCLEPIAS CURASSAVICA; ATROPA BELLADONNA; COPPER; ECHINACEA ANGUSTIFOLIA; HAEMOPHILUS INFLUENZAE TYPE B 5; 7; 5; 5; 3; 3; 9 [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g E 20171231 17089-046_b48e9662-3a99-4e2f-b83e-c6f46efcda9d 17089-046 HUMAN OTC DRUG ANTI AGE SKIN ALPHA-TOCOPHEROL - ASCOPHYLLUM NODOSUM - BOTRYOGLOSSUM PLATYCARPUM - FUCUS SERRATUS - FUCUS VESICULOSUS - ISOLEUCINE - LEUCINE - RETINOL - SELENIUM - SUS SCROFA CAPILLARY TISSUE - SUS SCROFA COLLAGEN PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ALPHA-TOCOPHEROL; LAMINARIA DIGITATA; BOTRYOGLOSSUM PLATYCARPUM; FUCUS SERRATUS; SUS SCROFA CAPILLARY TISSUE; UBIDECARENONE; SUS SCROFA COLLAGEN; FUCUS VESICULOSUS; ISOLEUCINE; ASCOPHYLLUM NODOSUM; LEUCINE; SUS SCROFA PLACENTA; RETINOL; ULVA LACTUCA EXTRACT; SELENIUM; SUS SCROFA SKIN 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g E 20171231 17089-061_72abcc1d-7658-4bd1-a138-6c12cbe4b09f 17089-061 HUMAN OTC DRUG ANTI AGE FACE ASIAN GINSENG - CANAKINUMAB - ELEUTHERO - GERMANIUM DIOXIDE - ISOLEUCINE - LEUCINE - PROLINE - SUS SCROFA COLLAGEN - SUS SCROFA SKIN - VALINE - WITCH HAZEL - PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa SUS SCROFA COLLAGEN; GERMANIUM DIOXIDE; ASIAN GINSENG; HAMAMELIS VIRGINIANA LEAF; CANAKINUMAB; ISOLEUCINE; LEUCINE; PROLINE; ELEUTHERO; SUS SCROFA SKIN; VALINE 4; 4; 3; 3; 5; 4; 4; 4; 3; 4; 9 [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g E 20171231 17089-067_a34bfc97-6822-47bf-8e2c-1764fc86103d 17089-067 HUMAN OTC DRUG ANTI AGE STRESS ACETYLCYSTEINE - BALLOTA FOETIDA - EPINEPHRINE - GLUTATHIONE - INTERFERON GAMMA-1B - LENOGRASTIM - LITHIUM CARBONATE - MELATONIN - PENICILLIUM GLABRUM - POTASSIUM CARBONATE - PUMMELO - RHODOTORULA RUB PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa EPINEPHRINE; EPINEPHRINE; SILVER NITRATE; BALLOTA FOETIDA; PUMMELO; SUS SCROFA CEREBRAL CORTEX; SUS SCROFA CEREBRAL CORTEX; LENOGRASTIM; GLUTATHIONE; INTERFERON GAMMA-1B; POTASSIUM CARBONATE; LITHIUM CARBONATE; MELATONIN; MELATONIN; ACETYLCYSTEINE; STRYCHNOS NUX-VOMICA SEED; STRYCHNOS NUX-VOMICA SEED; STRYCHNOS NUX-VOMICA SEED; STRYCHNOS NUX-VOMICA SEED; PENICILLIUM GLABRUM; RHODOTORULA RUBRA; SUS SCROFA STOMACH; SUS SCROFA SUPERIOR GASTRIC PLEXUS; SUS SCROFA THALAMUS 9; 15; 9; 3; 3; 4; 7; 4; 4; 5; 9; 8; 4; 15; 4; 5; 7; 9; 15; 8; 8; 7; 7; 7 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g E 20171231 17089-068_2e674588-6493-4b3e-8f51-95c720e44510 17089-068 HUMAN OTC DRUG ANTI AGE VEIN ACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CALCIUM FLUORIDE - CENTELLA ASIATICA - CINCHONA OFFICINALIS BARK - CRANBERRY - HORSE CHESTNUT - IRON - LACH PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ACONITUM NAPELLUS; HORSE CHESTNUT; PINEAPPLE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; SUS SCROFA ARTERY; ATROPA BELLADONNA; CALCIUM FLUORIDE; CINCHONA OFFICINALIS BARK; IRON; WITCH HAZEL; CENTELLA ASIATICA; LACHESIS MUTA VENOM; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MERCURY; CRANBERRY; PULSATILLA VULGARIS; SUS SCROFA VEIN; VISCUM ALBUM FRUIT 10; 3; 3; 10; 10; 12; 4; 10; 8; 10; 10; 3; 3; 10; 7; 10; 3; 10; 4; 3 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g E 20171231 17089-075_c15ed9e7-0fb7-4ea6-829b-3439c05a4760 17089-075 HUMAN OTC DRUG OMEOSPORT .ALPHA.-KETOGLUTARIC ACID - ACONITIC ACID, CIS - ADENOSINE TRIPHOSPHATE - ALPHA LIPOIC ACID - ASCORBIC ACID - ASIAN GINSENG - BARIUM CATION - BEET - CEROUS OXALATE NONAHYDRATE - COENZYME A - CYSTEINE PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ADENOSINE TRIPHOSPHATE; .ALPHA.-KETOGLUTARIC ACID; ALPHA LIPOIC ACID; ASCORBIC ACID; BARIUM OXALOSUCCINATE; BEET; CEROUS OXALATE NONAHYDRATE; ACONITIC ACID, CIS-; COENZYME A; CYSTEINE; SUS SCROFA EMBRYO; FUMARIC ACID; ASIAN GINSENG; SUS SCROFA ADRENAL GLAND; LACTIC ACID; MAGNESIUM CARBONATE; MALIC ACID; MANGANESE PHOSPHATE, DIBASIC; PORK; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SUCCINIC ACID; THIAMINE HYDROCHLORIDE 8; 6; 6; 4; 6; 2; 6; 6; 6; 6; 6; 6; 3; 10; 8; 2; 6; 6; 6; 6; 6; 6; 6; 6; 4 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g E 20171231 17089-076_5101e745-1f5e-473f-b2d2-dd625e9cea96 17089-076 HUMAN OTC DRUG CITOMIX ALDESLEUKIN - BINETRAKIN - CANAKINUMAB - CENTELLA ASIATICA - CRANBERRY - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - LENOGRASTIM - PINEAPPLE - SUS SCROFA BONE MARROW - SUS SCROFA SMA PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa PINEAPPLE; LENOGRASTIM; CENTELLA ASIATICA; INTERFERON GAMMA-1B; CANAKINUMAB; ALDESLEUKIN; BINETRAKIN; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; SUS SCROFA BONE MARROW; CRANBERRY; SUS SCROFA THYMUS 3; 4; 3; 4; 5; 5; 4; 7; 4; 4; 3; 4 [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g E 20171231 17089-231_8ca7517a-9bd7-4e93-945c-4d391a9ef022 17089-231 HUMAN OTC DRUG GUNA-FEM ADENOSINUM CICLOPHOSPHORICUM - LILIUM TIGRINUM - MELATONIN - SUS SCROFA ADRENAL GLAND - SUS SCROFA CORPUS LUTEUM - SUS SCROFA HYPOTHALAMUS - SUS SCROFA OVARY - SUS SCROFA PANCREAS - SUS SCROFA PINEAL SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ADENOSINE CYCLIC 3',5'-PHOSPHATE; SUS SCROFA CORPUS LUTEUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; LILIUM TIGRINUM; MELATONIN; SUS SCROFA OVARY; SUS SCROFA PANCREAS; SUS SCROFA PINEAL GLAND; SUS SCROFA THYMUS; THYROID 6; 30; 30; 30; 30; 6; 200; 6; 30; 30; 30; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-233_fcfa9fde-5872-4e52-ac1e-949aadb2688a 17089-233 HUMAN OTC DRUG GUNA-MALE ADENOSINUM CICLOPHOSPHORICUM - MELATONIN - PHOSPHORUS - SUS SCROFA ADRENAL GLAND - SUS SCROFA HYPOTHALAMUS - SUS SCROFA PANCREAS - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - SUS SCROFA TES SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ADENOSINE CYCLIC 3',5'-PHOSPHATE; TURNERA DIFFUSA TOP; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; MELATONIN; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA PINEAL GLAND; SUS SCROFA THYMUS; THYROID 6; 6; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-235_e307bc6e-8268-4e12-8832-0453194b3b98 17089-235 HUMAN OTC DRUG GUNA-TONSILS ANGELICA SINENSIS ROOT - BINETRAKIN - INTERLEUKIN-3 - LENOGRASTIM - MELATONIN - REISHI - SHIITAKE MUSHROOM - SUS SCROFA BLOOD - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA SPLEEN - I PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ANGELICA SINENSIS ROOT; SUS SCROFA BLOOD; LENOGRASTIM; INTERLEUKIN-11; INTERLEUKIN-3; BINETRAKIN; SHIITAKE MUSHROOM; REISHI; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MELATONIN; SUS SCROFA SPLEEN 3; 7; 4; 5; 5; 4; 8; 8; 4; 4; 4 [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g E 20171231 17089-237_1303b1fe-a794-47f7-a0d1-051071458112 17089-237 HUMAN OTC DRUG GUNA-REACT ANGELICA SINENSIS ROOT - ARNICA MONTANA - ASIAN GINSENG - ECHINACEA ANGUSTIFOLIA - FOMITOPSIS PINICOLA FRUITING BODY - INTERFERON GAMMA-1B - PAEONIA OFFICINALIS ROOT - PORK LIVER - REISHI - SILYBUM MA PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ANGELICA SINENSIS ROOT; ARNICA MONTANA; SILYBUM MARIANUM SEED; ECHINACEA ANGUSTIFOLIA; ASIAN GINSENG; PORK LIVER; INTERFERON GAMMA-1B; REISHI; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; PAEONIA OFFICINALIS ROOT; FOMITOPSIS PINICOLA FRUITING BODY; TURMERIC 3; 4; 3; 3; 1; 4; 4; 8; 4; 3; 8; 3 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g E 20171231 17089-242_6384cbc2-dcb1-be89-e053-2991aa0acd65 17089-242 HUMAN OTC DRUG GUNA-ADDICT 1 CAFFEINE - CHELIDONIUM MAJUS - DIEFFENBACHIA SEGUINE - JUNIPER - MATRICARIA RECUTITA - NICOTINE - PAPAVER RHOEAS FLOWER - PLANTAGO MAJOR - SCROPHULARIA NODOSA - SODIUM CHLORIDE - STRYCHNOS NUX-VOMICA SEED - SUGARCANE - TOBACCO LEAF - SOLUTION/ DROPS ORAL 20060523 20210228 UNAPPROVED HOMEOPATHIC Guna spa CAFFEINE; DIEFFENBACHIA SEGUINE; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; JUNIPER; SODIUM CHLORIDE; NICOTINE; STRYCHNOS NUX-VOMICA SEED; PAPAVER RHOEAS FLOWER; PLANTAGO MAJOR; SUGARCANE; SCROPHULARIA NODOSA; TOBACCO LEAF 6; 4; 1; 1; 1; 9; 6; 9; 12; 1; 6; 1; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20191231 17089-243_65fff701-7e92-4355-9a70-9ae39f5ae64c 17089-243 HUMAN OTC DRUG GUNA-ADDICT 2 ASIAN GINSENG - AVENA SATIVA FLOWERING TOP - BLACK CURRANT - MATRICARIA RECUTITA - ELEUTHERO - ESCHSCHOLZIA CALIFORNICA - HOPS - HYPERICUM PERFORATUM - PASSIFLORA INCARNATA TOP - POTASSIUM PHOSPHATE, SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa AVENA SATIVA FLOWERING TOP; BLACK CURRANT; MATRICARIA RECUTITA; ESCHSCHOLZIA CALIFORNICA; ASIAN GINSENG; HOPS; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; PASSIFLORA INCARNATA TOP; PULSATILLA VULGARIS; PULSATILLA VULGARIS; PULSATILLA VULGARIS; ELEUTHERO; STEVIA LEAF; VALERIAN 1; 1; 3; 1; 2; 1; 3; 8; 1; 6; 9; 12; 1; 1; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-251_8458a94a-0f00-46ba-8deb-7af4ec3a4597 17089-251 HUMAN OTC DRUG GUNA-VIRUS ALDESLEUKIN - EVERLASTING EXTRACT - FOMITOPSIS PINICOLA FRUITING BODY - INTERFERON GAMMA-1B - MELATONIN - METENKEFALIN - REISHI - RICE - SEROTONIN - SOYBEAN - SUS SCROFA BLOOD - SUS SCROFA SMALL INTES PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ALDESLEUKIN; EVERLASTING EXTRACT; FOMITOPSIS PINICOLA FRUITING BODY; INTERFERON GAMMA-1B; METENKEFALIN; REISHI; RICE; SEROTONIN; SOYBEAN; SUS SCROFA BLOOD; SUS SCROFA SPLEEN; MELATONIN; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE 5; 3; 8; 3; 4; 8; 3; 6; 3; 4; 4; 15; 7 [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g E 20171231 17089-259_c9122c19-6294-416c-a56d-f706a8ae8bf3 17089-259 HUMAN OTC DRUG OSTEOBIOS CALCITONIN HUMAN - CALCIUM CARBONATE - CALCIUM FLUORIDE - CALCIUM PHOSPHATE - ISOLEUCINE - LEUCINE - LYSINE - METHIONINE - PHENYLALANINE - SUS SCROFA BONE - SUS SCROFA PARATHYROID GLAND - THREONINE - SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa CALCITONIN HUMAN; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; CALCIUM CARBONATE; CALCIUM FLUORIDE; CALCIUM PHOSPHATE; SUS SCROFA BONE; SUS SCROFA PARATHYROID GLAND 6; 3; 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-260_32e6dc57-b71f-402f-8ae5-d46ab78e1b50 17089-260 HUMAN PRESCRIPTION DRUG GUNA-DIUR AMILORIDE - APIS MELLIFERA - BERBERIS VULGARIS FRUIT - HIERACIUM PILOSELLA FLOWERING TOP - HYDROCHLOROTHIAZIDE - SOLIDAGO VIRGAUREA FLOWERING TOP - SPIRONOLACTONE - SUS SCROFA PITUITARY GLAND - SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa AMILORIDE; APIS MELLIFERA; BERBERIS VULGARIS FRUIT; HYDROCHLOROTHIAZIDE; SUS SCROFA PITUITARY GLAND; HIERACIUM PILOSELLA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; SPIRONOLACTONE 4; 2; .3; 4; 12; .3; .3; 4 [hp_X]/30mL; [hp_X]/30mL; mL/30mL; [hp_X]/30mL; [hp_X]/30mL; mL/30mL; mL/30mL; [hp_X]/30mL Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 17089-265_be6c2c70-9776-4dbc-85b4-c719eb005c6b 17089-265 HUMAN OTC DRUG GUNA-MOOD 5-HYDROXY TRYPTOPHAN,DL - ALFALFA - AVENA SATIVA FLOWERING TOP - LACHESIS MUTA VENOM - PHOSPHORIC ACID - SALIX ALBA BARK - SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI - SEPIA OFFICINALIS JUICE - SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa 5-HYDROXYTRYPTOPHAN, DL-; ALFALFA; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; PHOSPHORIC ACID; SUS SCROFA PINEAL GLAND; SALIX ALBA BARK; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; SEPIA OFFICINALIS JUICE; SEROTONIN; SUS SCROFA THYMUS; TRYPTOPHAN 3; 6; 6; 30; 30; 200; 200; 10; 30; 30; 30; 200; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-269_ad09b988-a13a-4039-918f-90889940221e 17089-269 HUMAN OTC DRUG GUNA-TF HERPES HUMAN HERPESVIRUS 1 - HUMAN HERPESVIRUS 2 - CAPSULE, GELATIN COATED ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2 7; 7 [hp_X]/4600mg; [hp_X]/4600mg E 20171231 17089-280_4a23899d-80e0-447b-9d88-22a9f3ffbe49 17089-280 HUMAN OTC DRUG GUNA-TF CANDIDA CANDIDA ALBICANS CAPSULE, GELATIN COATED ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa CANDIDA ALBICANS 7 [hp_X]/4600mg E 20171231 17089-281_69423426-fa1c-4b19-bbe5-fe63ddb688e4 17089-281 HUMAN OTC DRUG GUNA-TF PAPILLOMA HUMAN PAPILLOMAVIRUS CAPSULE, GELATIN COATED ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa HUMAN PAPILLOMAVIRUS 7 [hp_X]/4600mg E 20171231 17089-290_c1c8fd84-05fd-44ac-bf4d-a7a532bd146a 17089-290 HUMAN OTC DRUG GUNA-PMS ARSENIC TRIOXIDE - ESTRADIOL - GOLDENSEAL - LACHESIS MUTA VENOM - MAGNESIUM PHOSPHATE - MATRICARIA RECUTITA - MELATONIN - PROGESTERONE - STRYCHNOS NUX-VOMICA SEED - SULFUR - SUS SCROFA OVARY - SUS SCR SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ARSENIC TRIOXIDE; ESTRADIOL; GOLDENSEAL; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE; MATRICARIA RECUTITA; MELATONIN; PROGESTERONE; STRYCHNOS NUX-VOMICA SEED; SULFUR; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND 6; 6; 6; 4; 6; 6; 4; 6; 6; 6; 8; 8 [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-291_0e8e6d96-f6d6-4354-8428-5b8e7c136f8c 17089-291 HUMAN OTC DRUG GUNA-LYMPHO APIS MELLIFERA - CALENDULA OFFICINALIS FLOWER - CENTELLA ASIATICA - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - EQUISETUM HYEMALE - FUMARIC ACID - GOLDENSEAL - GRAPHITE - JUGLANS REGIA LEAF - LEVOTHYROXINE - SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa APIS MELLIFERA; CALENDULA OFFICINALIS FLOWER; SUS SCROFA CAPILLARY TISSUE; MALIC ACID; EQUISETUM HYEMALE; FUMARIC ACID; GRAPHITE; GOLDENSEAL; CENTELLA ASIATICA; JUGLANS REGIA LEAF; LEVOTHYROXINE; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MAGNESIUM PHOSPHATE; MYOSOTIS ARVENSIS; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHYTOLACCA AMERICANA ROOT; SARSAPARILLA; TARAXACUM OFFICINALE; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; SUS SCROFA VEIN 8; 1; 6; 6; 3; 6; 30; 1; 1; 3; 12; 6; 6; 3; 6; 6; 3; 3; 1; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-293_e9896bd2-5e01-4cc1-9c6d-90a33898abf2 17089-293 HUMAN OTC DRUG GUNA-BOWEL ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - CHOLECALCIFEROL - COLLINSONIA - FRANGULA ALNUS BARK - NIACIN - PANTOTHENIC ACID - POTASSIUM CARBONATE - RHUBARB - SILYBUM MARIANUM SEED SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CHOLECALCIFEROL; COLLINSONIA; SUS SCROFA COLON; POTASSIUM CARBONATE; SODIUM CARBONATE; NIACIN; STRYCHNOS NUX-VOMICA SEED; PANTOTHENIC ACID; SUS SCROFA RECTUM; FRANGULA ALNUS BARK; RHUBARB; SKATOLE; TARAXACUM OFFICINALE; THIAMINE 2; 6; 6; 2; 2; 2; 2; 12; 6; 6; 2; 6; 2; 12; 2; 2; 10; 2; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-294_7593c032-7ad0-4a59-9725-c8d5eafb6831 17089-294 HUMAN OTC DRUG GUNA-SLEEP AVENA SATIVA FLOWERING TOP - CANAKINUMAB - CHAMOMILE - HELLEBORUS NIGER ROOT - MELATONIN - MELISSA OFFICINALIS - PULSATILLA VULGARIS - SEROTONIN - STRYCHNOS IGNATII SEED - SUS SCROFA PINEAL GLAND - VA SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa AVENA SATIVA FLOWERING TOP; CHAMOMILE; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; CANAKINUMAB; MELATONIN; MELISSA OFFICINALIS; SUS SCROFA PINEAL GLAND; SUS SCROFA PINEAL GLAND; SUS SCROFA PINEAL GLAND; PULSATILLA VULGARIS; SEROTONIN; VALERIAN 6; 6; 6; 6; 4; 4; 6; 6; 12; 30; 6; 6; 6 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 17089-295_defde9e4-8e07-4454-a089-1865c0f5e667 17089-295 HUMAN OTC DRUG GUNA-DERMO ALDESLEUKIN - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CANAKINUMAB - ECHINACEA ANGUSTIFOLIA - GRAPHITE - MELATONIN - PLANTAGO MAJOR - SOLANUM DULCAMARA FLOWER - SULFUR - SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ALDESLEUKIN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CANAKINUMAB; ECHINACEA ANGUSTIFOLIA; GRAPHITE; MELATONIN; PLANTAGO MAJOR; SOLANUM DULCAMARA FLOWER; SULFUR 4; 6; 6; 7; 6; 6; 4; 4; 6; 6 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 17089-296_98275e11-99b5-4311-b697-f522355967cb 17089-296 HUMAN OTC DRUG GUNA-HEMORRHOIDS ACTIVATED CHARCOAL - ARNICA MONTANA - ATROPA BELLADONNA - CANAKINUMAB - HYDROCOTYLE ASIATICA EXTRACT - AESCULUS HIPPOCASTANUM FLOWER - MELISSA OFFICINALIS - PAEONIA OFFICINALIS ROOT - PODOPHYLLUM PELT SOLUTION/ DROPS ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa AESCULUS HIPPOCASTANUM FLOWER; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; CANAKINUMAB; ARNICA MONTANA; ATROPA BELLADONNA; ACTIVATED CHARCOAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; HYDROCOTYLE ASIATICA EXTRACT; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; MELISSA OFFICINALIS; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; PODOPHYLLUM PELTATUM ROOT; SUS SCROFA VEIN 6; 4; 4; 6; 6; 10; 6; 12; 6; 6; 6; 6; 6; 4; 4 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 17089-298_2857ee3a-3a7b-468a-b370-06f4596806ea 17089-298 HUMAN OTC DRUG GUNA-KIDNEY CHONDRODENDRON TOMENTOSUM ROOT - CLERODENDRANTHUS SPICATUS LEAF - EQUISETUM HYEMALE - ESCHERICHIA COLI - HIERACIUM PILOSELLA FLOWERING TOP - METHYLENE BLUE - NITRIC ACID - ONONIS CAMPESTRIS - PLANTAGO SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ESCHERICHIA COLI; EQUISETUM HYEMALE; POTASSIUM NITRATE; PORK KIDNEY; METHYLENE BLUE; HIERACIUM PILOSELLA FLOWERING TOP; NITRIC ACID; ONONIS CAMPESTRIS; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; PLANTAGO MAJOR; PROTEUS VULGARIS; QUINHYDRONE; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; SUCCINIC ACID; SUS SCROFA URETER; SUS SCROFA URINARY BLADDER 12; 3; 12; 8; 8; 1; 12; 2; 2; 2; 2; 12; 8; 2; 1; 6; 8; 8 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-299_8e14ec39-4a98-4fdf-b8d3-a9476a3e5370 17089-299 HUMAN OTC DRUG GUNA-ALLERGY-PREV AMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERF SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa AMBROSIA ARTEMISIIFOLIA; ARUNDO PLINIANA ROOT; ASCLEPIAS CURASSAVICA; BLACK CURRANT; CITRIC ACID MONOHYDRATE; HISTAMINE DIHYDROCHLORIDE; INTERFERON GAMMA-1B; HUMAN INTERLEUKIN 12; MANGANESE GLUCONATE; SODIUM PYRUVATE; SODIUM SULFATE; PARIETARIA OFFICINALIS; PHLEUM PRATENSE; ANGUILLA ROSTRATA BLOOD SERUM; SUCCINIC ACID; SULFUR; URTICA URENS; VIBURNUM OPULUS ROOT; WYETHIA HELENIOIDES ROOT 18; 18; 6; 1; 6; 30; 4; 4; 4; 6; 200; 18; 18; 200; 6; 30; 18; 3; 18 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; mL/30mL; [hp_X]/30mL E 20171231 17089-301_08245f08-3952-4524-89ab-440ee4a6ffb5 17089-301 HUMAN OTC DRUG GUNA-DIGEST ANGELICA ARCHANGELICA ROOT - ANISUM - ARTEMISIA ABROTANUM FLOWERING TOP - ASCORBIC ACID - CITRULLUS COLOCYNTHIS FRUIT PULP - GENTIANA LUTEA ROOT - MELATONIN - NIACIN - PANCRELIPASE AMYLASE - PANCRELIP SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ARTEMISIA ABROTANUM FLOWERING TOP; PANCRELIPASE AMYLASE; ANGELICA ARCHANGELICA ROOT; ANISUM; ASCORBIC ACID; CITRULLUS COLOCYNTHIS FRUIT PULP; SUS SCROFA DIENCEPHALON; SUS SCROFA DUODENUM; SUS SCROFA GALL BLADDER; GENTIANA LUTEA ROOT; PORK LIVER; PANCRELIPASE LIPASE; MELATONIN; NIACIN; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; SUS SCROFA PYLORUS; SEROTONIN; THIAMINE HYDROCHLORIDE; TRYPSIN; TRYPTOPHAN 1; 2; 1; 1; 2; 3; 6; 8; 8; 1; 8; 2; 4; 2; 3; 8; 8; 6; 4; 2; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-302_6197c0b1-e4c3-4206-8b84-6c103a9f5d7b 17089-302 HUMAN OTC DRUG GUNA-STOMACH ACTIVATED CHARCOAL - ANTIMONY TRISULFIDE - BISMUTH SUBNITRATE - DIOSCOREA VILLOSA ROOT - DOPAMINE - HUMAN EPIDERMAL GROWTH FACTOR - IPECAC - OREGANO - PICEA MARIANA RESIN - ROBINIA PSEUDOACACIA BARK - PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa PICEA MARIANA RESIN; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; DIOSCOREA VILLOSA ROOT; DOPAMINE; HUMAN EPIDERMAL GROWTH FACTOR; IPECAC; MOMORDICA BALSAMINA IMMATURE FRUIT; OREGANO; ROBINIA PSEUDOACACIA BARK; SUS SCROFA STOMACH; SUS SCROFA SYMPATHETIC NERVE 3; 30; 30; 30; 6; 6; 3; 6; 4; 30; 3; 10; 2; 30; 6 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g E 20171231 17089-304_9d59a335-db26-44b1-815f-5d603fac7554 17089-304 HUMAN OTC DRUG GUNA-ARTHRO .ALPHA.-KETOGLUTARIC ACID - ALPHA LIPOIC ACID - ASCORBIC ACID - BARIUM OXALOSUCCINATE - BLACK COHOSH - BRYONIA ALBA ROOT - CALCITONIN HUMAN - CHLORINE - COLCHICUM AUTUMNALE BULB - NADIDE - SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa .ALPHA.-KETOGLUTARIC ACID; ALPHA LIPOIC ACID; SUS SCROFA ARTERY; ASCORBIC ACID; BARIUM OXALOSUCCINATE; BRYONIA ALBA ROOT; CALCITONIN HUMAN; SUS SCROFA CARTILAGE; CHLORINE; BLACK COHOSH; COLCHICUM AUTUMNALE BULB; SUS SCROFA CONJUNCTIVA; SOLANUM DULCAMARA FLOWER; VELAFERMIN; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; NADIDE; SODIUM DIETHYL OXALACETATE; NERVE GROWTH FACTOR; SUS SCROFA PARATHYROID GLAND; SUS SCROFA PLACENTA; QUINHYDRONE; TOXICODENDRON PUBESCENS LEAF; STRONTIUM CARBONATE; SULFUR; SUS SCROFA VEIN; PRASTERONE 3; 3; 6; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 4; 6; 6; 3; 3; 4; 6; 6; 3; 6; 6; 3; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-306_de54315b-c73e-4e8b-b35f-79c78a3c3dd0 17089-306 HUMAN OTC DRUG GUNA-DIZZY .ALPHA.-KETOGLUTARIC ACID - AMBERGRIS - ANAMIRTA COCCULUS SEED - CONIUM MACULATUM FLOWERING TOP - EPINEPHRINE - FUMARIC ACID - MALIC ACID - MELATONIN - MINERAL OIL - PTERIDIUM AQUILINUM ROOT - PYRIDOX SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa EPINEPHRINE; .ALPHA.-KETOGLUTARIC ACID; AMBERGRIS; SUS SCROFA ARTERY; SUS SCROFA CEREBELLUM; QUININE SALICYLATE; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; FUMARIC ACID; MALIC ACID; MELATONIN; MINERAL OIL; SUS SCROFA PLACENTA; PTERIDIUM AQUILINUM ROOT; PYRIDOXINE HYDROCHLORIDE; QUINHYDRONE; TOBACCO LEAF; THIAMINE HYDROCHLORIDE 6; 6; 6; 6; 6; 6; 4; 3; 6; 6; 4; 8; 6; 8; 6; 6; 6; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-311_b7c55c65-bd66-4003-8aa2-b8b384b90085 17089-311 HUMAN OTC DRUG GUNA-LIVER CEANOTHUS AMERICANUS LEAF - CHELIDONIUM MAJUS - CHIONANTHUS VIRGINICUS BARK - CHOLINE HYDROXIDE - COBALAMIN - CULVER ROOT - FUMARIC ACID - INOSITOL - LYCOPODIUM CLAVATUM SPORE - NIACIN - PORK LIVER - PELLET ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa SILYBUM MARIANUM SEED; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHOLINE HYDROXIDE; COBALAMIN; FUMARIC ACID; SUS SCROFA GALL BLADDER; PORK LIVER; INOSITOL; SUS SCROFA JEJUNUM; POTASSIUM SULFATE; POTASSIUM SULFATE; POTASSIUM SULFATE; CULVER'S ROOT; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; SODIUM SULFATE; SODIUM SULFATE; NIACIN; SUS SCROFA PANCREAS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SUS SCROFA SPLEEN; TARAXACUM OFFICINALE; THIAMINE HYDROCHLORIDE 2; 6; 2; 6; 4; 4; 4; 8; 6; 4; 8; 6; 8; 12; 6; 6; 4; 4; 6; 8; 12; 6; 8; 6; 6; 8; 2; 6 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g E 20171231 17089-337_3ae5eb9a-7a4f-4c91-92b5-9bf9feb19e6f 17089-337 HUMAN OTC DRUG GUNA-RERIO DANIO RERIO EGG SOLUTION/ DROPS ORAL 20070418 UNAPPROVED HOMEOPATHIC Guna spa DANIO RERIO EGG 4 [hp_X]/30mL E 20171231 17089-346_97ce693a-9c10-4e4c-b8d2-3b7f60f93234 17089-346 HUMAN OTC DRUG GUNA-PROSTATE ALDESLEUKIN - BARIUM CARBONATE - CHASTE TREE - CHIMAPHILA UMBELLATA - CLEMATIS VITALBA - CONIUM MACULATUM FLOWERING TOP - DELPHINIUM STAPHISAGRIA SEED - DIGITALIS - FERRIC PICRATE - HUMAN INTERLEUKIN- SOLUTION/ DROPS ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa CHASTE TREE; BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; FERRIC PICRATE; INTERFERON GAMMA-1B; HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED); ALDESLEUKIN; MELATONIN; SUS SCROFA PROSTATE; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; TRANSFORMING GROWTH FACTOR BETA-1; THUJA OCCIDENTALIS TWIG; ZINC 6; 30; 6; 3; 30; 30; 30; 4; 4; 4; 4; 200; 3; 30; 30; 4; 30; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-347_f572ca8f-fcc7-4d50-aa94-0a23221478f5 17089-347 HUMAN OTC DRUG GUNA-HYPERTENSION ARNICA MONTANA - FUMARIC ACID - GOLD - LEAD - MELATONIN - MELILOTUS - OLEA EUROPAEA FLOWER - PORK KIDNEY - RAUWOLFIA SERPENTINA - SODIUM PYRUVATE - SPIGELIA - SUS SCROFA ADRENAL GLAND - SUS SCROFA DIE SOLUTION/ DROPS ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa ARNICA MONTANA; GOLD; UBIDECARENONE; SUS SCROFA DIENCEPHALON; FUMARIC ACID; SUS SCROFA ADRENAL GLAND; PORK KIDNEY; MELATONIN; MELILOTUS; SODIUM PYRUVATE; OLEA EUROPAEA FLOWER; LEAD; RAUWOLFIA SERPENTINA; SPIGELIA; VISCUM ALBUM FRUIT 12; 12; 3; 6; 3; 200; 6; 4; 6; 3; 3; 12; 6; 6; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-348_6d62d1f8-a3e4-4d9f-83a6-fa9ce116d062 17089-348 HUMAN OTC DRUG GUNA-SPASM ATROPINE SULFATE - BERBERIS VULGARIS ROOT BARK - CHELIDONIUM MAJUS - COBALT - CULTIVATED MUSHROOM - GELSEMIUM SEMPERVIRENS ROOT - INTERLEUKIN-10 - MAGNESIUM - MELATONIN - METENKEFALIN - SUS SCROFA SYM SOLUTION/ DROPS ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa CULTIVATED MUSHROOM; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; METENKEFALIN; CHELIDONIUM MAJUS; COBALT; WATERMELON; GELSEMIUM SEMPERVIRENS ROOT; INTERLEUKIN-10; MAGNESIUM; MELATONIN; SUS SCROFA SYMPATHETIC NERVE; SUS SCROFA VAGUS NERVE 4; 4; 6; 3; 4; 4; 4; 4; 6; 4; 4; 4; 200; 6 [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-349_27ce5a7c-4174-4bf5-9c58-05f2bb74d09a 17089-349 HUMAN OTC DRUG GUNA-GERIATRICS 1,4-BENZOQUINONE - ARNICA MONTANA - OXYTOCIN - BARIUM CARBONATE - BARIUM OXALOSUCCINATE - CORTICOTROPIN - LEAD - LEVOTHYROXINE - LUTRELIN - MALIC ACID - MELATONIN - NEUROTROPHIN-3 - NEUROTROPHIN-4 - P SOLUTION/ DROPS ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa CORTICOTROPIN; ARNICA MONTANA; BARIUM OXALOSUCCINATE; BARIUM CARBONATE; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; MALIC ACID; SUS SCROFA FRONTAL LOBE; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; RINFABATE; LUTRELIN; MELATONIN; NEUROTROPHIN-3; NEUROTROPHIN-4; OXYTOCIN; 1,4-BENZOQUINONE; PHENYLALANINE; LEAD; PYRUVIC ACID; THYROTROPIN ALFA; LEVOTHYROXINE 6; 6; 3; 6; 4; 3; 6; 6; 6; 6; 4; 6; 4; 4; 4; 6; 3; 3; 6; 3; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-350_29d041d6-96e1-4c0d-a94d-33618467c63d 17089-350 HUMAN OTC DRUG GUNA-AWARENESS BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTRO SOLUTION/ DROPS ORAL 20080416 UNAPPROVED HOMEOPATHIC Guna spa GOLD; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BUFO BUFO CUTANEOUS GLAND; CALCIUM CARBONATE; CHROMIC SULFATE; CICUTA VIROSA ROOT; COBALAMIN; UBIDECARENONE; COPPER; IRON; FOLIC ACID; SUS SCROFA FRONTAL LOBE; LACHESIS MUTA VENOM; MELATONIN; MOLYBDENUM; NEUROTROPHIN-3; NEUROTROPHIN-4; OXYTOCIN; SILICON DIOXIDE; SUS SCROFA TEMPORAL LOBE; THYROTROPIN ALFA; BETAINE; VANADIUM; ZINC 12; 4; 12; 3; 3; 12; 3; 3; 12; 3; 3; 6; 12; 4; 3; 4; 4; 6; 12; 6; 3; 3; 6; 3 [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-359_a81d6d6e-1c06-447b-af8d-3b06f2c87ec5 17089-359 HUMAN PRESCRIPTION DRUG GUNA-Beta-ESTRADIOL ESTRADIOL SOLUTION/ DROPS ORAL 20081216 UNAPPROVED HOMEOPATHIC Guna spa ESTRADIOL 6 [hp_X]/30mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 17089-370_7063a3a8-3559-446a-bffd-13ee2eb30cf1 17089-370 HUMAN OTC DRUG GUNA-BDNF BRAIN-DERIVED NEUROTROPHIC FACTOR SOLUTION/ DROPS ORAL 20110331 UNAPPROVED HOMEOPATHIC Guna spa BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN 4 [hp_C]/30mL E 20171231 17089-372_a5188106-8314-491c-a99d-45cb8a06f84e 17089-372 HUMAN OTC DRUG GUNA-EGF EPIDERMAL GROWTH FACTOR SOLUTION/ DROPS ORAL 20110331 UNAPPROVED HOMEOPATHIC Guna spa HUMAN EPIDERMAL GROWTH FACTOR 4 [hp_C]/30mL E 20171231 17089-373_691f8684-b424-449a-9229-de2ae3cc9a50 17089-373 HUMAN OTC DRUG GUNA-FGF FIBROBLAST GROWTH FACTOR SOLUTION/ DROPS ORAL 20110331 UNAPPROVED HOMEOPATHIC Guna spa VELAFERMIN 4 [hp_C]/30mL E 20171231 17089-375_a6da122b-13e5-4631-8109-c4c3528933e4 17089-375 HUMAN OTC DRUG GUNA-GCSF GRANULOCYTE COLONY STIMULATING FACTOR SOLUTION/ DROPS ORAL 20110331 UNAPPROVED HOMEOPATHIC Guna spa LENOGRASTIM 4 [hp_C]/30mL E 20171231 17089-376_4a57751f-8fc6-417c-9065-12d4f919fb9d 17089-376 HUMAN OTC DRUG GUNA-IGF INSULIN-LIKE GROWTH FACTOR-1 SOLUTION/ DROPS ORAL 20110331 UNAPPROVED HOMEOPATHIC Guna spa MECASERMIN 4 [hp_C]/30mL E 20171231 17089-378_ea0105cf-badd-4558-8404-e626f8e54bc3 17089-378 HUMAN OTC DRUG GUNA-INF GAMMA INTERFERON GAMMA-1B SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERFERON GAMMA-1B 4 [hp_C]/30mL E 20171231 17089-380_b7483673-5095-45dd-aa14-99ced01acf0f 17089-380 HUMAN OTC DRUG GUNA-IL 2 ALDESLEUKIN SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa ALDESLEUKIN 4 [hp_C]/30mL E 20171231 17089-381_fa342d07-0ca8-4d86-a78b-6afd6a024393 17089-381 HUMAN OTC DRUG GUNA-IL 3 INTERLEUKIN-3 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-3 4 [hp_C]/30mL E 20171231 17089-382_ec902a0e-7148-4d3f-bd00-da1926618736 17089-382 HUMAN OTC DRUG GUNA-IL 4 BINETRAKIN SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa BINETRAKIN 4 [hp_C]/30mL E 20171231 17089-383_a7689b78-4dec-4280-8985-c228fc5972a4 17089-383 HUMAN OTC DRUG GUNA-IL 5 INTERLEUKIN-5 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-5 4 [hp_C]/30mL E 20171231 17089-385_b0daef11-1480-49ba-92c4-984491d9ffcc 17089-385 HUMAN OTC DRUG GUNA-IL 7 INTERLEUKIN-7 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-7 4 [hp_C]/30mL E 20171231 17089-386_cbb51ffa-772d-4cc6-9f58-69c60c0862ad 17089-386 HUMAN OTC DRUG GUNA-IL 8 INTERLEUKIN-8 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-8 4 [hp_C]/30mL E 20171231 17089-387_1102e964-98be-412b-ad78-85dbb084cbb6 17089-387 HUMAN OTC DRUG GUNA-IL 9 INTERLEUKIN-9 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-9 4 [hp_C]/30mL E 20171231 17089-388_4405c502-6b75-4be9-9bdb-851344dfa0b1 17089-388 HUMAN OTC DRUG GUNA-IL 10 INTERLEUKIN-10 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-10 4 [hp_C]/30mL E 20171231 17089-389_503d0a06-2a91-4590-9367-c5b4c789773b 17089-389 HUMAN OTC DRUG GUNA-IL 11 INTERLEUKIN-11 SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-11 4 [hp_C]/30mL E 20171231 17089-390_41f04aff-a3d1-4ce0-9e50-4b17f1617c4f 17089-390 HUMAN OTC DRUG GUNA-IL 12 INTERLEUKIN-12 HUMAN RECOMBINANT SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa INTERLEUKIN-12 HUMAN RECOMBINANT 4 [hp_C]/30mL E 20171231 17089-395_af732ad2-8563-4e80-8a02-c3585c14cf70 17089-395 HUMAN OTC DRUG GUNA-TGF BETA 1 TRANSFORMING GROWTH FACTOR BETA 1 SOLUTION/ DROPS ORAL 20110331 UNAPPROVED HOMEOPATHIC Guna spa TRANSFORMING GROWTH FACTOR BETA-1 4 [hp_C]/30mL E 20171231 17089-398_9056a1e0-543d-468a-ae9c-cb2cb3322823 17089-398 HUMAN OTC DRUG GUNA-ANTI IL 1 ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT- CANAKINUMAB SOLUTION/ DROPS ORAL 20080617 UNAPPROVED HOMEOPATHIC Guna spa ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; CANAKINUMAB 4; 4 [hp_C]/30mL; [hp_C]/30mL E 20171231 17089-405_147412c4-d624-4d98-ac2b-b66db0b78839 17089-405 HUMAN OTC DRUG GAMMA -12 INTERLEUKIN-12 HUMAN RECOMBINANT - INTERFERON GAMMA-1B - SOLUTION/ DROPS ORAL 20100429 UNAPPROVED HOMEOPATHIC Guna spa INTERFERON GAMMA-1B; INTERLEUKIN-12 HUMAN RECOMBINANT 4; 4 [hp_C]/30mL; [hp_C]/30mL E 20171231 17089-406_cad85703-cb8b-4387-97ef-3e50afd028a0 17089-406 HUMAN OTC DRUG GUNA-REFLUX ACTIVATED CHARCOAL - AETHUSA CYNAPIUM - APOMORPHINE HYDROCHLORIDE - BRYONIA ALBA ROOT - COLCHICUM AUTUMNALE BULB - IPECAC - LYCOPODIUM CLAVATUM SPORE - STRYCHNOS IGNATII SEED - STRYCHNOS NUX-VOMICA SE SOLUTION/ DROPS ORAL 20100512 UNAPPROVED HOMEOPATHIC Guna spa AETHUSA CYNAPIUM; APOMORPHINE HYDROCHLORIDE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; SUS SCROFA STOMACH; COLCHICUM AUTUMNALE BULB; WATERMELON; SUS SCROFA ESOPHAGUS; STRYCHNOS IGNATII SEED; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED 4; 6; 30; 12; 10; 6; 30; 10; 6; 4; 5; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-408_7b63ea98-d031-4283-92ba-b23dac5b98ea 17089-408 HUMAN OTC DRUG GUNA-VENUS ALETRIS FARINOSA ROOT - ALDESLEUKIN - ALPHA LIPOIC ACID - ATOSIBAN - CHASTE TREE - COBALAMIN - COPPER - CORTICOTROPIN - COTTON - CYCLAMEN PURPURASCENS TUBER - DOPAMINE - FOLIC ACID - FOLLICLE STIMULAT PELLET ORAL 20100427 UNAPPROVED HOMEOPATHIC Guna spa CORTICOTROPIN; CHASTE TREE; ALETRIS FARINOSA ROOT; ALPHA LIPOIC ACID; COBALAMIN; COPPER; CYCLAMEN PURPURASCENS TUBER; TURNERA DIFFUSA TOP; PRASTERONE; DOPAMINE; FOLIC ACID; FOLLICLE STIMULATING HORMONE BETA POLYPEPTIDE; LEVANT COTTON OIL; HYDROQUINONE; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; ALDESLEUKIN; LUTROPIN ALFA; LUTRELIN; LYCOPODIUM CLAVATUM SPORE; SUS SCROFA OVARY; ATOSIBAN; SEPIA OFFICINALIS JUICE; SEROTONIN; SUS SCROFA SPLEEN; SUCCINIC ACID; ZINC 6; 4; 4; 4; 4; 4; 4; 4; 6; 6; 4; 6; 4; 4; 6; 6; 4; 6; 6; 30; 6; 6; 30; 6; 6; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g E 20171231 17089-415_605a72af-0afc-40c7-8dac-f4b482d2aeab 17089-415 HUMAN OTC DRUG EUBIOFLOR ACTIVATED CHARCOAL - AETHUSA CYNAPIUM - ALTHAEA OFFICINALIS LEAF - BILBERRY - CANDIDA ALBICANS - UNCARIA TOMENTOSA - ESCHERICHIA COLI - INDOLE - MERCURIUS SOLUBILIS - OKOUBAKA AUBREVILLEI BARK - PORK SOLUTION/ DROPS ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa AETHUSA CYNAPIUM; ALTHAEA OFFICINALIS LEAF; CANDIDA ALBICANS; ACTIVATED CHARCOAL; SILYBUM MARIANUM SEED; CAT'S CLAW; ESCHERICHIA COLI; SUS SCROFA COLON; SUS SCROFA GALL BLADDER; PORK LIVER; INDOLE; STRYCHNOS NUX-VOMICA SEED; OKOUBAKA AUBREVILLEI BARK; SUS SCROFA PANCREAS; TABEBUIA IMPETIGINOSA BARK; PROTEUS VULGARIS; SKATOLE; TARAXACUM OFFICINALE; BILBERRY; VERATRUM ALBUM ROOT; MERCURIUS SOLUBILIS 6; 4; 30; 6; 4; 4; 30; 30; 6; 12; 12; 6; 6; 12; 4; 12; 30; 4; 4; 6; 200 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-416_3563b6ae-c94e-4620-a431-91d49e158784 17089-416 HUMAN OTC DRUG GUNA-MATRIX ASCORBIC ACID - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - FUCUS VESICULOSUS - HISTIDINE MONOHYDROCHLORIDE - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - HYALURONIDASE - LACTIC ACID, DL - MALIC ACID - NADIDE - P SOLUTION/ DROPS ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ASCORBIC ACID; SUS SCROFA CONJUNCTIVA; PRASTERONE; MALIC ACID; FUCUS VESICULOSUS; HISTIDINE MONOHYDROCHLORIDE; HYALURONIDASE; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); LACTIC ACID, DL-; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; NADIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; PHENYLALANINE; PROLACTIN; RANCID BEEF; THUJA OCCIDENTALIS TWIG; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; TYROSINE 4; 6; 6; 6; 4; 4; 6; 4; 4; 6; 6; 6; 6; 12; 4; 6; 12; 12; 6; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-417_1d496774-7395-4864-8518-c669ab743c61 17089-417 HUMAN OTC DRUG GUNA-FLAM ACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENK SOLUTION/ DROPS ORAL 20060523 UNAPPROVED HOMEOPATHIC Guna spa ACONITUM NAPELLUS; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APIS MELLIFERA; ATROPA BELLADONNA; METENKEFALIN; BRYONIA ALBA ROOT; CITRIC ACID MONOHYDRATE; SUS SCROFA CONJUNCTIVA; BASIC CUPRIC CARBONATE; FERRIC PHOSPHATE; CALCIUM SULFIDE; SUS SCROFA PITUITARY GLAND; INTERLEUKIN-10; MELATONIN; SODIUM PYRUVATE; PHYTOLACCA AMERICANA ROOT; SUS SCROFA PINEAL GLAND; RANCID BEEF; TRANSFORMING GROWTH FACTOR BETA-1 6; 4; 6; 6; 6; 6; 3; 12; 4; 6; 6; 200; 4; 4; 3; 6; 6; 30; 4 [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL E 20171231 17089-418_7962d1bb-7762-422f-9440-f7d1223293a2 17089-418 HUMAN OTC DRUG GUNA-ALLERGY T AMMONIUM CARBONATE - APIS MELLIFERA - ARSENIC TRIOXIDE - BLATTA ORIENTALIS - CUPRIC ACETATE - DRIMIA MARITIMA BULB - EPINEPHRINE - GALPHIMIA GLAUCA FLOWERING TOP - HISTAMINE DIHYDROCHLORIDE - LUFFA OP SOLUTION/ DROPS ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa EPINEPHRINE; ONION; AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; BLATTA ORIENTALIS; SUS SCROFA BRONCHUS; CUPRIC ACETATE; GALPHIMIA GLAUCA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; MANGANESE GLUCONATE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; DRIMIA MARITIMA BULB 6; 30; 30; 200; 30; 12; 200; 30; 12; 12; 200; 12; 4; 200; 30; 30; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-419_7c1aea30-21bb-4b15-85da-caccc4b460e5 17089-419 HUMAN OTC DRUG GUNA-RHINO NOSE SPRAY APIS MELLIFERA - ARALIA RACEMOSA ROOT - ASCORBIC ACID - BLACK CURRANT - COPPER - EUPHORBIA RESINIFERA RESIN - EUROPEAN ELDERBERRY - HELIANTHEMUM CANADENSE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUK SPRAY ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; SILVER NITRATE; ASCORBIC ACID; BLACK CURRANT; HELIANTHEMUM CANADENSE; COPPER; EUPHORBIA RESINIFERA RESIN; HISTAMINE DIHYDROCHLORIDE; INTERFERON GAMMA-1B; HUMAN INTERLEUKIN-10 (NONGLYCOSYLATED); HUMAN INTERLEUKIN 12; MANGANESE GLUCONATE; MELILOTUS; PLANTAGO MAJOR; ROSA CANINA FRUIT; EUROPEAN ELDERBERRY 8; 12; 1; 10; 2; 1; 4; 4; 4; 200; 4; 4; 4; 4; 3; 2; 1; 2 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-420_4903dff0-7854-4774-9651-82f0e31bf90b 17089-420 HUMAN OTC DRUG MICOX ASPERGILLUS NIGER VAR. NIGER - CANDIDA ALBICANS - CENTELLA ASIATICA - MALIC ACID - MERCURIC CHLORIDE - RHIZOPUS STOLONIFER - SODIUM DIETHYL OXALACETATE - SULFUR - TABEBUIA IMPETIGINOSA BARK - SOLUTION/ DROPS ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; MALIC ACID; CENTELLA ASIATICA; MERCURIC CHLORIDE; RHIZOPUS STOLONIFER; SODIUM DIETHYL OXALACETATE; TABEBUIA IMPETIGINOSA BARK; SULFUR 30; 30; 12; 6; 6; 30; 12; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-450_40b7699a-43f1-498e-80b0-a432142e78f9 17089-450 HUMAN OTC DRUG GUNA-CELL ACETYLCARNITINE, L-AMPc-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE- SOLUTION/ DROPS ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ACETYLCARNITINE, L-; ADENOSINE CYCLIC 3',5'-PHOSPHATE; ALPHA LIPOIC ACID; .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CALCIUM CARBONATE; CITRIC ACID MONOHYDRATE; COBALAMIN; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; CUPRIC SULFATE; HERRING SPERM DNA; FERROUS FUMARATE; FOLIC ACID; FUMARIC ACID; PYRUVALDEHYDE; POTASSIUM ASPARTATE; MAGNESIUM PHOSPHATE; MANGANESE GLUCONATE; MANGANESE PHOSPHATE, DIBASIC; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; NIACIN; PANTOTHENIC ACID; PHOSPHORUS; PODOPHYLLUM PELTATUM ROOT; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SACCHAROMYCES CEREVISIAE RNA; SELENOMETHIONINE; SUCCINIC ACID; SULFUR; THIAMINE HYDROCHLORIDE; ZINC 3; 6; 3; 3; 3; 3; 3; 3; 6; 6; 3; 6; 3; 3; 3; 10; 3; 3; 3; 6; 3; 3; 3; 3; 4; 6; 6; 6; 6; 3; 3; 3; 4; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-451_39f21e73-19b6-484a-b11d-06db20f60af8 17089-451 HUMAN OTC DRUG GUNA-SINUS NOSE SPRAY ALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ON SPRAY ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ONION; ALTHAEA OFFICINALIS LEAF; SILVER NITRATE; ASCORBIC ACID; BLACK CURRANT; LOBARIA PULMONARIA; COPPER; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MANGANESE; MERCURIC SULFIDE; SUS SCROFA NASAL MUCOSA; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILICON DIOXIDE; SINUSITISINUM; SUS SCROFA THYMUS; SUS SCROFA URINARY BLADDER 8; 2; 10; 2; 1; 2; 3; 3; 8; 8; 8; 30; 3; 8; 12; 2; 8; 8; 30; 12; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-452_01447aa9-556b-4ae9-aa89-f05f15a5f716 17089-452 HUMAN OTC DRUG GUNA-ORAL SPRAY ACHILLEA MILLEFOLIUM - ACONITUM NAPELLUS - ARNICA MONTANA - ATROPA BELLADONNA - CALCIUM SULFIDE - COMFREY ROOT - ECHINACEA ANGUSTIFOLIA - ECHINACEA PURPUREA - HYPERICUM PERFORATUM - SUS SCROFA TOOTH - SPRAY ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; WITCH HAZEL; CALCIUM SULFIDE; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; COMFREY ROOT; SUS SCROFA TOOTH 3; 3; 4; 2; 2; 2; 6; 3; 3; 6; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 17089-453_954bfe17-6d04-4ed2-9a37-a212517107eb 17089-453 HUMAN OTC DRUG GUNA-COUGH ALTHAEA OFFICINALIS LEAF - ANTIMONY POTASSIUM TARTRATE - BRYONIA ALBA ROOT - CETRARIA ISLANDICA SUBSP. ISLANDICA - COCHINEAL - COPPER - DROSERA ROTUNDIFOLIA - ECHINACEA ANGUSTIFOLIA - GARDEN THYME - L SOLUTION/ DROPS ORAL 20100527 UNAPPROVED HOMEOPATHIC Guna spa ALTHAEA OFFICINALIS LEAF; ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; COCHINEAL; COPPER; DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA; PLANTAGO MAJOR; LOBARIA PULMONARIA; THYME 1; 8; 6; 4; 6; 8; 1; 1; 1; 4; 1 [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL E 20171231 17089-454_be73d29d-36bb-4801-a8da-252cfe5d0882 17089-454 HUMAN OTC DRUG GUNA-MARS .ALPHA.-KETOGLUTARIC ACID - CHASTE TREE - CONIUM MACULATUM FLOWERING TOP - CORTICOTROPIN - DOPAMINE - FOLLITROPIN - GOLD - INTERLEUKIN-10 - LUTRELIN - LUTROPIN ALFA - LYCOPODIUM CLAVATUM SPORE - MALIC PELLET ORAL 20100818 UNAPPROVED HOMEOPATHIC Guna spa CORTICOTROPIN; CHASTE TREE; .ALPHA.-KETOGLUTARIC ACID; OVEMOTIDE; GOLD; CONIUM MACULATUM FLOWERING TOP; TURNERA DIFFUSA LEAFY TWIG; PRASTERONE; MALIC ACID; DOPAMINE; FOLLITROPIN; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; RINFABATE; INTERLEUKIN-10; POTASSIUM IODATE; LUTROPIN ALFA; LUTRELIN; LYCOPODIUM CLAVATUM SPORE; SUS SCROFA TESTICLE; PYRUVIC ACID; SEROTONIN; SUS SCROFA SPLEEN; SUS SCROFA URETHRA; SUS SCROFA VEIN; ZINC 6; 4; 4; 6; 6; 4; 4; 6; 4; 6; 6; 6; 6; 4; 4; 4; 6; 6; 30; 6; 4; 6; 6; 6; 6; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g E 20171231 17089-456_338b94d8-da07-4ebb-b464-6264883db1b1 17089-456 HUMAN OTC DRUG GUNA-INF ALPHA INTERFERON ALFA-2A SOLUTION/ DROPS ORAL 20110216 UNAPPROVED HOMEOPATHIC Guna spa INTERFERON ALFA-2A 4 [hp_C]/30mL E 20171231 17089-458_073ce065-7db6-4289-92f2-255f7a0d3ca7 17089-458 HUMAN OTC DRUG GUNA-MELATONIN MELATONIN SOLUTION/ DROPS ORAL 20110523 UNAPPROVED HOMEOPATHIC Guna spa MELATONIN 4 [hp_C]/30mL E 20171231 17089-459_8fd273af-ca0d-4c0c-9987-4d0ddee5c101 17089-459 HUMAN OTC DRUG GUNA-VTL ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT - CANAKINUMAB - BINETRAKIN - INTERLEUKIN-10 - METENKEFALIN SOLUTION/ DROPS ORAL 20141205 UNAPPROVED HOMEOPATHIC Guna spa ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; CANAKINUMAB; BINETRAKIN; INTERLEUKIN-10; METENKEFALIN 4; 4; 4; 4; 4 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 17134-001_2d3b16b6-832a-4bf2-8b7b-d12f3c9834cf 17134-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19770101 UNAPPROVED MEDICAL GAS Roberts Home Medical, Inc. OXYGEN 990 mL/L E 20171231 17139-613_74285ccb-8cb6-4c29-a5ec-1fe1999658b6 17139-613 HUMAN PRESCRIPTION DRUG EstroGel estradiol GEL, METERED TRANSDERMAL 20040209 NDA NDA021166 ASCEND Therapeutics US, LLC ESTRADIOL .75 mg/1.25g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 17139-617_c8b35a38-6c41-4d93-8de8-ab35f093c396 17139-617 HUMAN PRESCRIPTION DRUG EstroGel estradiol GEL, METERED TOPICAL 20040209 NDA NDA021166 ASCEND Therapeutics US, LLC ESTRADIOL .75 mg/1.25g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 17156-021_e5f8fb8d-3a5d-492b-9a1f-8e4e5cf595cf 17156-021 HUMAN PRESCRIPTION DRUG Indium in 111 Oxyquinoline Indium In-111 Oxyquinoline SOLUTION INTRAVENOUS 19851201 NDA NDA019044 Medi-Physics Inc. dba GE Healthcare. INDIUM IN-111 OXYQUINOLINE 1 ug/mL N 20181231 17156-022_a947af02-e821-4d23-a66f-c4d61182d545 17156-022 HUMAN PRESCRIPTION DRUG CERETEC TECHNETIUM TC-99M EXAMETAZIME INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19881230 NDA NDA019829 Medi-Physics Inc. dba GE Healthcare. TECHNETIUM TC-99M EXAMETAZIME .5 mg/5mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 17156-023_a0ad9c36-5223-46cb-883d-3764a0689cd0 17156-023 HUMAN PRESCRIPTION DRUG Ceretec Exametazime KIT 19881230 NDA NDA019829 Medi-Physics Inc. N 20181231 17156-026_aaa8939a-e4f3-4b07-b54b-bd2a86c5c944 17156-026 HUMAN PRESCRIPTION DRUG Myoview Tetrofosmin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090226 NDA NDA020372 Medi-Physics Inc. dba GE Healthcare TETROFOSMIN 1.38 mg/1 N 20181231 17156-067_51d693ac-e841-4d4b-a86d-60ef194d19d8 17156-067 HUMAN PRESCRIPTION DRUG Vizamyl Flutemetamol F-18 SOLUTION INTRAVENOUS 20140101 NDA NDA203137 Medi-Physics Inc. FLUTEMETAMOL F-18 4.05 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 17156-210_db9a31fa-2639-4852-bea8-4e82ca982fc8 17156-210 HUMAN PRESCRIPTION DRUG DaTscan Ioflupane I-123 INJECTION, SOLUTION INTRAVENOUS 20110301 NDA NDA022454 Medi-Physics Inc. dba GE Healthcare. IOFLUPANE I-123 2 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 17156-235_bf3ce582-7976-4708-be4d-4fb30c0336dd 17156-235 HUMAN PRESCRIPTION DRUG AdreView Iobenguane I-123 INJECTION INTRAVENOUS 20080919 NDA NDA022290 Medi-Physics Inc. IOBENGUANE I-123 2 mCi/mL N 20181231 17156-251_7eec6bf3-d492-4cbe-91c9-92ebcbc88e1b 17156-251 HUMAN PRESCRIPTION DRUG Indium DTPA In 111 Indium In-111 Pentetate Disodium SOLUTION INTRATHECAL 19820218 NDA NDA017707 Medi-Physics, Inc. dba GE Healthcare INDIUM IN-111 PENTETATE DISODIUM 1 mCi/mL N 20181231 17156-299_d1490ed9-5cf7-454f-acd1-a2716140dba2 17156-299 HUMAN PRESCRIPTION DRUG THALLOUS CHLORIDE TL 201 Thallous Chloride Tl-201 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19820201 NDA NDA018110 Medi-Physics, Inc. dba GE Healthcare THALLOUS CHLORIDE TL-201 1 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 17156-523_596c20ff-b75c-4a19-aa23-fa8f738f4e59 17156-523 HUMAN PRESCRIPTION DRUG Indiclor Indium Chloride In-111 SOLUTION INTRAVENOUS 19921229 NDA NDA019862 Medi-Physics Inc. INDIUM CHLORIDE IN-111 5 mCi/.5mL N 20181231 17156-524_c91d3a32-be75-48dc-9cb1-c4df19f4ad10 17156-524 HUMAN PRESCRIPTION DRUG Metastron Strontium Chloride Sr-89 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19930618 NDA NDA020134 Medi-Physics Inc. STRONTIUM CHLORIDE SR-89 1 mCi/mL Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 17156-601_2a278230-dac2-4f8b-afb5-498f3827b505 17156-601 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-602_2a278230-dac2-4f8b-afb5-498f3827b505 17156-602 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-603_2a278230-dac2-4f8b-afb5-498f3827b505 17156-603 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-604_2a278230-dac2-4f8b-afb5-498f3827b505 17156-604 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-605_2a278230-dac2-4f8b-afb5-498f3827b505 17156-605 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-606_2a278230-dac2-4f8b-afb5-498f3827b505 17156-606 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-607_2a278230-dac2-4f8b-afb5-498f3827b505 17156-607 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-608_2a278230-dac2-4f8b-afb5-498f3827b505 17156-608 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-609_2a278230-dac2-4f8b-afb5-498f3827b505 17156-609 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-610_2a278230-dac2-4f8b-afb5-498f3827b505 17156-610 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-611_2a278230-dac2-4f8b-afb5-498f3827b505 17156-611 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-612_2a278230-dac2-4f8b-afb5-498f3827b505 17156-612 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-613_2a278230-dac2-4f8b-afb5-498f3827b505 17156-613 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-614_2a278230-dac2-4f8b-afb5-498f3827b505 17156-614 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-615_2a278230-dac2-4f8b-afb5-498f3827b505 17156-615 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-616_2a278230-dac2-4f8b-afb5-498f3827b505 17156-616 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-617_2a278230-dac2-4f8b-afb5-498f3827b505 17156-617 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17156-618_2a278230-dac2-4f8b-afb5-498f3827b505 17156-618 HUMAN PRESCRIPTION DRUG Drytec (Technetium Tc99m Generator) TECHNETIUM TC-99M SODIUM PERTECHNETATE KIT 20140401 NDA NDA017963 Medi-Physics Inc. N 20181231 17238-424_60560818-fd83-aaad-e053-2991aa0ac710 17238-424 HUMAN PRESCRIPTION DRUG Indocyanine Green Indocyanine Green and Water KIT 20080101 ANDA ANDA040811 HUB Pharmaceuticals LLC N 20181231 17238-610_6140e883-8107-44f3-e053-2991aa0a1ba1 17238-610 HUMAN OTC DRUG Goniovisc Ophthalmic Lubricant Hypromellose 2910 (4000 MPA.S) SOLUTION/ DROPS OPHTHALMIC 20111110 OTC MONOGRAPH FINAL part349 HUB Pharmaceuticals, LLC HYPROMELLOSE 2910 (4000 MPA.S) 25 mg/mL N 20181231 17238-625_6040b4ad-a872-004e-e053-2a91aa0ae787 17238-625 HUMAN OTC DRUG Sodium Chloride Sodium Chloride SOLUTION/ DROPS OPHTHALMIC 20130912 OTC MONOGRAPH FINAL part349 HUB Pharmaceuticals SODIUM CHLORIDE 50 mg/mL N 20181231 17238-900_f0179ef4-cf7b-417e-a017-c5f8675dc6d5 17238-900 HUMAN PRESCRIPTION DRUG BioGlo Fluorescein Sodium STRIP OPHTHALMIC 20120401 UNAPPROVED DRUG OTHER HUB Pharmaceuticals, Inc. FLUORESCEIN SODIUM 1 mg/mg Diagnostic Dye [EPC],Dyes [MoA] E 20171231 17238-920_614af764-63c9-437d-e053-2991aa0ad799 17238-920 HUMAN PRESCRIPTION DRUG GreenGlo Lissamine Green STRIP OPHTHALMIC 20120401 UNAPPROVED DRUG OTHER HUB Pharmaceuticals, Inc. LIGHT GREEN SF YELLOWISH 1.5 mg/1.5mg N 20181231 17271-107_e650a5a9-153b-413c-8ced-0d498eb8e8f3 17271-107 HUMAN OTC DRUG BD E-Z Scrub 107 chlorhexidine gluconate SOLUTION TOPICAL 19891024 ANDA ANDA072525 Becton, Dickinson and Company CHLORHEXIDINE GLUCONATE 40 g/1000mL N 20181231 17271-116_44fb59c1-002f-411d-a60c-c2197b5de41a 17271-116 HUMAN OTC DRUG BD E-Z Scrub Chloroxylenol SOLUTION TOPICAL 19890301 OTC MONOGRAPH NOT FINAL part333E Becton Dickinson and Company CHLOROXYLENOL 30 mg/mL E 20171231 17271-205_45a9f803-1d30-4e0a-bead-e984d887ccb0 17271-205 HUMAN OTC DRUG BD E-Z Scrub Povidone-Iodine SOLUTION TOPICAL 19950601 OTC MONOGRAPH NOT FINAL part333E Becton Dickinson and Company POVIDONE-IODINE 100 mg/mL E 20171231 17271-245_866675bf-963c-44e4-8a4b-0ab4262b3c6f 17271-245 HUMAN OTC DRUG BD E-Z Scrub Povidone-Iodine SOLUTION TOPICAL 19950601 OTC MONOGRAPH NOT FINAL part333E Becton Dickinson and Company POVIDONE-IODINE 50 mg/mL E 20171231 17271-501_ddd9d67c-6ab3-4ed8-87c6-82a67e8e9f64 17271-501 HUMAN OTC DRUG BD E-Z Care Alcohol SOLUTION TOPICAL 20040401 OTC MONOGRAPH NOT FINAL part333E Becton Dickinson and Company ALCOHOL 600 mg/mL N 20181231 17271-502_0b7583b0-e92e-4b24-8c47-bb748af4056d 17271-502 HUMAN OTC DRUG BD E-Z Scrub chloroxylenol SOLUTION TOPICAL 20000401 OTC MONOGRAPH NOT FINAL part333E Becton, Dickinson and Company CHLOROXYLENOL 30 mg/mL N 20181231 17271-503_ca453bcb-24a4-4226-8f89-8dd67b46a0d4 17271-503 HUMAN OTC DRUG BD E-Z Scrub Povidone-Iodine SOLUTION TOPICAL 20000401 OTC MONOGRAPH NOT FINAL part333E Becton Dickinson and Company POVIDONE-IODINE 50 mg/mL N 20181231 17271-505_7cf0d958-07c9-4a42-87a0-4ffa74ecaf57 17271-505 HUMAN OTC DRUG BD E-Z Scrub chlorhexidine gluconate SOLUTION TOPICAL 20060101 NDA NDA019127 Becton, Dickinson and Company CHLORHEXIDINE GLUCONATE 40 g/1000mL N 20181231 17271-506_bb6264b8-7f17-48b4-aa28-24d88018248c 17271-506 HUMAN OTC DRUG BD E-Z Scrub chlorhexidine gluconate SOLUTION TOPICAL 20010401 NDA NDA019422 Becton Dickinson and Company CHLORHEXIDINE GLUCONATE 20 mg/mL N 20181231 17271-507_75c8db6f-f2a0-46fc-bf95-1980f7b027c9 17271-507 HUMAN OTC DRUG BD Persist povidone-iodine, alcohol SOLUTION TOPICAL 19960221 OTC MONOGRAPH NOT FINAL part333A Becton Dickinson Infusion Therapy Systems Inc. POVIDONE-IODINE; ALCOHOL 85; 65 mg/mL; mg/mL E 20171231 17271-701_ebc8b008-a8b3-4c41-89e4-b413f7aab89f 17271-701 HUMAN PRESCRIPTION DRUG Sodium chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20170919 ANDA ANDA207310 Becton Dickinson and Company SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 17271-720_a3afd51d-b0e4-4ee4-83f5-eb63f9d5e840 17271-720 HUMAN PRESCRIPTION DRUG Dextrose Dextrose Monohydrate INJECTION, SOLUTION INTRAVENOUS 20161021 ANDA ANDA207449 Becton Dickinson and Company DEXTROSE MONOHYDRATE 50 mg/mL N 20181231 17312-001_40872c05-306c-5acc-e054-00144ff88e88 17312-001 HUMAN OTC DRUG Ring Relief Arnica Montana, Calcium Sulfide, Hypericum Perforatum, Lycopodium Clavatum Spore, Thiosinaminum, Mercurius Solubilis, Salicylic Acid, Silicon Dioxide, Allylthiourea LIQUID AURICULAR (OTIC) 20060601 UNAPPROVED HOMEOPATHIC TRP Company ARNICA MONTANA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE; ALLYLTHIOUREA 6; 13; 6; 12; 13; 6; 13; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 17312-002_40855f1d-2e6f-4355-e054-00144ff8d46c 17312-002 HUMAN OTC DRUG Blur Relief Jacobaea Maritima, Calcium Fluoride, Conium Maculatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, Sodium Chloride, Ruta Graveolens Flowering Top LIQUID INTRAOCULAR 20060601 UNAPPROVED HOMEOPATHIC TRP Company JACOBAEA MARITIMA; CALCIUM FLUORIDE; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; SODIUM CHLORIDE; RUTA GRAVEOLENS FLOWERING TOP 5; 13; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 17312-003_747751c1-49c6-499c-9f28-93806138de11 17312-003 HUMAN OTC DRUG Ring Relief Potassium Sulfate, Salicylic Acid, Silicon Dioxide, Calcium Sulfate Anhydrous, Quinine Sulfate, Allylthiourea TABLET, MULTILAYER ORAL 20060601 UNAPPROVED HOMEOPATHIC TRP Company POTASSIUM SULFATE; SALICYLIC ACID; SILICON DIOXIDE; CALCIUM SULFATE ANHYDROUS; QUININE SULFATE; ALLYLTHIOUREA; CITRUS BIOFLAVONOIDS; GINKGO; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PANTOTHENIC ACID; PYRIDOXINE; CYANOCOBALAMIN; BIOTIN; FOLIC ACID; INOSITOL; ZINC PICOLINATE; ASCORBIC ACID 6; 6; 6; 6; 12; 6; 300; 30; .5; .5; 10; 2.5; .5; 200; 100; 200; 37.5; 7.5; 150 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1 E 20171231 17312-004_dcbfff46-0e86-46be-b01e-b6bf9bf639ba 17312-004 HUMAN OTC DRUG Temporary Fibromyalgia Pain and Discomfort Relief Aconitum Napellus, Atropa Belladonna, Causticum, Magnesium Phosphate, Dibasic, Strychnos Nux-Vomica Seed, Toxicodendron Pubescens Leaf TABLET, MULTILAYER ORAL 20100201 UNAPPROVED HOMEOPATHIC TRP Company ACONITUM NAPELLUS; ATROPA BELLADONNA; CAUSTICUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; MAGNESIUM ASCORBATE; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; MAGNESIUM ASCORBATE; MAGNESIUM OXIDE; SELENIUM; SEDUM ROSEUM ROOT 6; 6; 6; 6; 6; 6; 200; 1; 1; 20; 1; 400; 400; 200; 5; 75; 75; 100; 200 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1 E 20171231 17312-013_5f248416-c8fb-98b2-e053-2991aa0aa855 17312-013 HUMAN OTC DRUG Pink Eye Relief ACONITUM NAPELLUS - APIS MELLIFERA - SILVER NITRATE - EUPHRASIA STRICTA - SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE - LIQUID AURICULAR (OTIC) 20120901 UNAPPROVED HOMEOPATHIC TRP Company EUPHRASIA STRICTA; SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE; ACONITUM NAPELLUS; APIS MELLIFERA; SILVER NITRATE 6; 11; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 17312-014_4665b712-1c23-59c8-e054-00144ff8d46c 17312-014 HUMAN OTC DRUG Stye Relief APIS MELLIFERA - CARBON DISULFIDE - PULSATILLA VULGARIS - SILICON DIOXIDE - DELPHINIUM STAPHISAGRIA SEED - OINTMENT TOPICAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company APIS MELLIFERA; CARBON DISULFIDE; PULSATILLA VULGARIS; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED 6; 6; 6; 6; 6 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 17312-015_e09d6756-b5e0-43b6-90e4-aa1110c435cf 17312-015 HUMAN OTC DRUG Ring Relief ARNICA MONTANA - CALCIUM SULFIDE - HYPERICUM PERFORATUM - LYCOPODIUM CLAVATUM SPORE - MERCURIUS SOLUBILIS - SALICYLIC ACID - SILICON DIOXIDE - ALLYLTHIOUREA - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ARNICA MONTANA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE; ALLYLTHIOUREA 6; 13; 6; 12; 13; 6; 13; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-016_40872c05-305b-5acc-e054-00144ff88e88 17312-016 HUMAN OTC DRUG Temporary Fibromyalgia Pain and Discomfort Relief ATROPA BELLADONNA - BRYONIA ALBA ROOT - CAUSTICUM - PHOSPHORUS - STRYCHNOS NUX-VOMICA SEED - PULSATILLA VULGARIS - TOXICODENDRON PUBESCENS LEAF - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAUSTICUM; PHOSPHORUS; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 17312-017_30283f2a-23ad-4ad0-a11a-48fc4a3deca8 17312-017 HUMAN OTC DRUG Asthma Therapy ARSENIC TRIOXIDE - HISTAMINE DIHYDROCHLORIDE - DERMATOPHAGOIDES PTERONYSSINUS - MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - STRYCHNOS NUX-VOMICA SEED - ASPIDOSPERMA QUEBRACHO-BLANCO BARK - SUPLHUR - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ARSENIC TRIOXIDE; HISTAMINE DIHYDROCHLORIDE; DERMATOPHAGOIDES PTERONYSSINUS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; SULFUR 6; 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 17312-018_14c0c65f-cd47-425c-bba5-faf3f2b5770d 17312-018 HUMAN OTC DRUG Bronchial Cough Therapy ANTIMONY POTASSIUM TARTRATE - PROTORTONIA CACTI - DROSERA ROTUNDIFOLIA - ECHINACEA, UNSPECIFIED - CALCIUM SULFIDE - HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED - SPONGIA OFFICINALIS SKELETON, ROASTED - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ANTIMONY POTASSIUM TARTRATE; PROTORTONIA CACTI; DROSERA ROTUNDIFOLIA; ECHINACEA, UNSPECIFIED; CALCIUM SULFIDE; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 6; 6; 6; 18; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 17312-019_4bfb8ad9-4fdb-6399-e054-00144ff8d46c 17312-019 HUMAN OTC DRUG Irritable Bowel Syndrome Therapy ASAFETIDA - BISMUTH SUBNITRATE - BRYONIA ALBA ROOT - ACTIVATED CHARCOAL - LYCOPODIUM CLAVATUM SPORE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - VERATRUM ALBUM ROOT - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ASAFETIDA; BISMUTH SUBNITRATE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 3; 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-020_e17019f3-d2e9-4920-b6ca-985a89f5e6bf 17312-020 HUMAN OTC DRUG Chronic Fatigue Therapy EPINEPHRINE - GOLD - HUMAN BREAST TUMOR CELL - ECHINACEA, UNSPECIFIED - GELSEMIUM SEMPERVIRENS ROOT - GINKGO - INFLUENZA B VIRUS - PHOSPHORIC ACID - SCUTELLARIA LATERIFLORA TOP - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company EPINEPHRINE; GOLD; HUMAN BREAST TUMOR CELL; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; INFLUENZA B VIRUS; PHOSPHORIC ACID; SCUTELLARIA LATERIFLORA TOP 3; 8; 24; 3; 6; 3; 12; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-021_40872c05-307f-5acc-e054-00144ff88e88 17312-021 HUMAN OTC DRUG Sciatica Therapy ARNICA MONTANA - CITRULLUS COLOCYNTHIS FRUIT PULP - PSEUDOGNAPHALIUM OBTUSIFOLIUM - HYPERICUM PERFORATUM - POTASSIUM IODIDE - MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - TOXICODENDRON PUBESCENS LEAF - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ARNICA MONTANA; CITRULLUS COLOCYNTHIS FRUIT PULP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM IODIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-022_6b682fed-90b0-49c0-b3a0-556568bc68cb 17312-022 HUMAN OTC DRUG Migraine Headache Therapy ATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; BLACK COHOSH; ARABICA COFFEE BEAN; NITROGLYCERIN; IRIS VERSICOLOR ROOT; SODIUM CHLORIDE 6; 6; 6; 3; 12; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-023_193728bf-2579-2d24-e054-00144ff88e88 17312-023 HUMAN OTC DRUG Ring Relief ARNICA MONTANA - CALCIUM SULFIDE - HYPERICUM PERFORATUM - LYCOPODIUM CLAVATUM SPORE - MERCURIUS SOLUBILIS - SALICYLIC ACID - SILICON DIOXIDE - ALLYLTHIOUREA - TABLET, ORALLY DISINTEGRATING ORAL 20111201 UNAPPROVED HOMEOPATHIC TRP Company ARNICA MONTANA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE; ALLYLTHIOUREA 6; 13; 6; 12; 13; 6; 13; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 17312-024_4331d36d-2f6b-4a45-a6ce-d18eb24f76de 17312-024 HUMAN OTC DRUG Pink Eye ACONITUM NAPELLUS - APIS MELLIFERA - SILVER NITRATE - EUPHRASIA STRICTA - SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE - LIQUID INTRAOCULAR 20120901 UNAPPROVED HOMEOPATHIC TRP Company ACONITUM NAPELLUS; APIS MELLIFERA; SILVER NITRATE; EUPHRASIA STRICTA; SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE 6; 6; 12; 6; 11 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 17312-025_58f62ccb-e29a-2b84-e053-2991aa0afe89 17312-025 HUMAN OTC DRUG EarAche Relief APIS MELLIFERA, ARNICA MONTANA, ATROPA BELLADONNA, TRIBASIC CALCIUM PHOSPHATE, ECHINACEA, UNSPECIFIED, CALCIUM SULFIDE, MERCURIUS SOLUBILIS TABLET, ORALLY DISINTEGRATING ORAL 20130905 UNAPPROVED HOMEOPATHIC TRP Company APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; ECHINACEA, UNSPECIFIED; CALCIUM SULFIDE; MERCURIUS SOLUBILIS 6; 6; 6; 6; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-026_45256b30-fcdd-4c14-a9af-6e6c119899fc 17312-026 HUMAN OTC DRUG Arthritis Therapy APIS MELLIFERA, BRYONIA ALBA ROOT, CALCIUM FLUORIDE, LITHIUM CARBONATE, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SALICYLIC ACID TABLET, ORALLY DISINTEGRATING ORAL 20130905 UNAPPROVED HOMEOPATHIC TRP Company APIS MELLIFERA; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; LITHIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID 6; 6; 6; 6; 6; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-027_59b4b696-4d84-7449-e053-2991aa0a3c6d 17312-027 HUMAN OTC DRUG AgingEye Relief TRIBASIC CALCIUM PHOSPHATE, CALENDULA OFFICINALIS FLOWERING TOP, CARBON DISULFIDE, JACOBAEA MARITIMA, CONIUM MACULATUM FLOWERING TOP, EUPHRASIA STRICTA, SELENIUM, ZINC LIQUID OPHTHALMIC 20140501 UNAPPROVED HOMEOPATHIC TRP Company TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; CARBON DISULFIDE; JACOBAEA MARITIMA; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; SELENIUM; ZINC 13; 3; 6; 5; 6; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 17312-029_13f6865e-8410-4c7b-e054-00144ff88e88 17312-029 HUMAN OTC DRUG Diarrhea Relief Aloe, Citrullus Colocynthis, Croton Tiglium, Lycopodium Clavatum, Magnesium Sulfate Heptahydrate, Phosphoric Acid, Thuja Occidentalis TABLET, ORALLY DISINTEGRATING ORAL 20150415 UNAPPROVED HOMEOPATHIC TRP Company LYCOPODIUM CLAVATUM SPORE; CROTON TIGLIUM SEED; CITRULLUS COLOCYNTHIS FRUIT PULP; ALOE; THUJA OCCIDENTALIS LEAFY TWIG; PHOSPHORIC ACID; MAGNESIUM SULFATE HEPTAHYDRATE 6; 6; 6; 5; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-030_14bd30e5-a982-597a-e054-00144ff8d46c 17312-030 HUMAN OTC DRUG Heartburn Relief Carbo MORE TABLET, ORALLY DISINTEGRATING ORAL 20150415 UNAPPROVED HOMEOPATHIC TRP Company POTASSIUM DICHROMATE; CHELIDONIUM MAJUS; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; GINGER; IRIS VERSICOLOR ROOT; ACTIVATED CHARCOAL 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-031_12dea1d1-9502-5aad-e054-00144ff8d46c 17312-031 HUMAN OTC DRUG Constipation Relief Aloe, Potassium Alum, Oyster Shell Calcium Carbonate, Crude Activated Charcoal, Dioscorea Villosa Tuber, Veronicastrum Virginicum Root, Strychnos Nux Vomica Seed TABLET, ORALLY DISINTEGRATING ORAL 20150415 UNAPPROVED HOMEOPATHIC TRP Company DIOSCOREA VILLOSA ROOT; ACTIVATED CHARCOAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM ALUM; ALOE; STRYCHNOS NUX-VOMICA SEED; VERONICASTRUM VIRGINICUM ROOT 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-032_5f25d04d-444d-fa20-e053-2a91aa0a64bb 17312-032 HUMAN OTC DRUG Allergy Eyes Relief Allium cepa, Ambrosia, Apis, Euphrasia, Histamine hydrochloricum, Sabadilla, Sulphur LIQUID OPHTHALMIC 20170803 UNAPPROVED HOMEOPATHIC TRP Company SULFUR; ALLIUM CEPA WHOLE; HISTAMINE; APIS MELLIFERA; EUPHRASIA STRICTA; AMBROSIA ARTEMISIIFOLIA; SCHOENOCAULON OFFICINALE SEED 6; 6; 12; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 17312-034_317ce456-aa6d-0b51-e054-00144ff8d46c 17312-034 HUMAN OTC DRUG Irritable Bowel Syndrome Therapy ASAFETIDA - BISMUTH SUBNITRATE - BRYONIA ALBA ROOT - ACTIVATED CHARCOAL - LYCOPODIUM CLAVATUM SPORE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - VERATRUM ALBUM ROOT - TABLET, ORALLY DISINTEGRATING ORAL 20160401 UNAPPROVED HOMEOPATHIC TRP Company ASAFETIDA; BISMUTH SUBNITRATE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 3; 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 17312-035_11e8fe93-8f89-473a-e054-00144ff88e88 17312-035 HUMAN OTC DRUG Smokers Nicotine Relief aspidosperma quebracho blanco, avena sativa, epinephrine, lobelia inflata, milk thistle, st johns wort, strychnos nux vomica seed, valerian, wood creosote GUM, CHEWING ORAL 20150322 UNAPPROVED HOMEOPATHIC TRP Company MILK THISTLE; ST. JOHN'S WORT; WOOD CREOSOTE; EPINEPHRINE; AVENA SATIVA FLOWERING TOP; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; VALERIAN 6; 18; 18; 18; 9; 12; 18; 18; 18 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-037_4aedd177-53d7-246e-e054-00144ff8d46c 17312-037 HUMAN OTC DRUG Smokers Nicotine Relief aspidosperma quebracho blanco, avena sativa, epinephrine, lobelia inflata, milk thistle, st johns wort, strychnos nux vomica seed, valerian, wood creosote LOZENGE ORAL 20150322 UNAPPROVED HOMEOPATHIC TRP Company AVENA SATIVA FLOWERING TOP; EPINEPHRINE; MILK THISTLE; ST. JOHN'S WORT; WOOD CREOSOTE; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; VALERIAN 9; 18; 6; 18; 18; 12; 18; 18; 18 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-041_317d3f42-783f-02b7-e054-00144ff88e88 17312-041 HUMAN OTC DRUG Migraine Headache Therapy ATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE - TABLET, ORALLY DISINTEGRATING ORAL 20160401 UNAPPROVED HOMEOPATHIC TRP Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; BLACK COHOSH; ARABICA COFFEE BEAN; NITROGLYCERIN; IRIS VERSICOLOR ROOT; SODIUM CHLORIDE 6; 6; 6; 3; 12; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 17312-042_158627e3-70f2-40eb-e054-00144ff88e88 17312-042 HUMAN OTC DRUG Temporary Fibromyalgia Pain and Discomfort Relief ATROPA BELLADONNA - BRYONIA ALBA ROOT - CAUSTICUM - PHOSPHORUS - STRYCHNOS NUX-VOMICA SEED - PULSATILLA VULGARIS - TOXICODENDRON PUBESCENS LEAF - TABLET, ORALLY DISINTEGRATING ORAL 20150507 UNAPPROVED HOMEOPATHIC TRP Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAUSTICUM; PHOSPHORUS; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 17312-043_1936fbed-7290-600e-e054-00144ff8d46c 17312-043 HUMAN OTC DRUG Ring Relief ARNICA MONTANA - CALCIUM SULFIDE - HYPERICUM PERFORATUM - LYCOPODIUM CLAVATUM SPORE - MERCURIUS SOLUBILIS - SALICYLIC ACID - SILICON DIOXIDE - ALLYLTHIOUREA - TABLET, ORALLY DISINTEGRATING ORAL 20150622 UNAPPROVED HOMEOPATHIC TRP Company ARNICA MONTANA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE; ALLYLTHIOUREA 6; 13; 6; 12; 13; 6; 13; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 17312-056_2e91a3de-e900-5d65-e054-00144ff8d46c 17312-056 HUMAN OTC DRUG Apetite Relief Avena sativa, Berberis vulgaris, Calcarea carbonica, Capsicum annuum, Carbo vegetabilis, Fucus vesiculosus, Nux vomica, Thyroidinum LOZENGE ORAL 20160301 UNAPPROVED HOMEOPATHIC TRP Company AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CAPSICUM; THYROID, UNSPECIFIED; FUCUS VESICULOSUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; STRYCHNOS NUX-VOMICA SEED 9; 12; 6; 18; 6; 6; 6; 18 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 17312-203_58f2bf97-875f-5857-e053-2a91aa0a13ff 17312-203 HUMAN OTC DRUG Walgreens EarAche Drops ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, and SULFUR LIQUID AURICULAR (OTIC) 20170803 UNAPPROVED HOMEOPATHIC TRP Company ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA CHAMOMILLA; LYCOPODIUM CLAVATUM SPORE; ANEMONE PULSATILLA; SULFUR 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 17420-1008_08718ab0-765a-63c4-e054-00144ff8d46c 17420-1008 HUMAN OTC DRUG Arnica montana 3C Arnica montana PELLET ORAL 20141122 UNAPPROVED HOMEOPATHIC P. Banerji Mihijam Pharmaceuticals ARNICA MONTANA 3 [hp_C]/1 E 20171231 17429-010_7b1f8c97-aaeb-460d-8882-ba19adb9c76e 17429-010 HUMAN OTC DRUG Yat Tip Xiao External Analgesic Plaster for Removal of Corns and Calluses PLASTER TOPICAL 19770101 OTC MONOGRAPH FINAL part348 Huangshi Hygenic Material Pharmacy Co. Ltd. SALICYLIC ACID; PHENOL 780; 40 mg/1; mg/1 E 20171231 17433-9876_4d7ab8a4-f84a-4e47-a104-ca0e3d7f6785 17433-9876 HUMAN OTC DRUG ENEMEEZ DOCUSATE SODIUM LIQUID RECTAL 20120615 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DBA Summit Pharmaceuticals DOCUSATE SODIUM 283 mg/5mL N 20181231 17433-9877_a385116f-e477-4960-b91e-c15a558ba5d0 17433-9877 HUMAN OTC DRUG ENEMEEZ Plus DOCUSATE SODIUM and BENZOCAINE LIQUID RECTAL 20120615 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DBA Summit Pharmaceuticals DOCUSATE SODIUM; BENZOCAINE 283; 20 mg/5mL; mg/5mL N 20181231 17433-9878_1314f58a-cb0e-1eba-e054-00144ff88e88 17433-9878 HUMAN OTC DRUG Docusol docusate sodium LIQUID RECTAL 20130708 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DBA Summit Pharmaceuticals DOCUSATE SODIUM 283 mg/5mL N 20181231 17433-9878_2a1d1169-b293-4707-be8e-2fb90644e5f2 17433-9878 HUMAN OTC DRUG Docusol docusate sodium LIQUID RECTAL 20130708 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DBA Summit Pharmaceuticals DOCUSATE SODIUM 283 mg/5mL N 20181231 17433-9883_05f5eb41-83d7-4549-e054-00144ff8d46c 17433-9883 HUMAN OTC DRUG Docusol Plus docusate sodium w/benzocaine LIQUID RECTAL 20130712 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DBA Summit Pharmaceuticals DOCUSATE SODIUM; BENZOCAINE 283; 20 mg/5mL; mg/5mL N 20181231 17433-9883_13160f00-7878-53e5-e054-00144ff8d46c 17433-9883 HUMAN OTC DRUG Docusol Plus docusate sodium w/benzocaine LIQUID RECTAL 20150320 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DBA Summit Pharmaceuticals DOCUSATE SODIUM; BENZOCAINE 283; 20 mg/5mL; mg/5mL N 20181231 17433-9884_b1a53f5b-b2b7-45df-bb9a-f68d5e6b77bc 17433-9884 HUMAN OTC DRUG Docusol Kids docusate sodium LIQUID RECTAL 20140114 OTC MONOGRAPH NOT FINAL part334 Enemeez Inc. DBA Summit Pharmaceuticals DOCUSATE SODIUM 100 mg/5mL N 20181231 17433-9990_5fdb61bb-5140-b22a-e053-2a91aa0ab4de 17433-9990 HUMAN OTC DRUG CVS Kids Mini Enema docusate sodium LIQUID RECTAL 20141115 20180531 OTC MONOGRAPH NOT FINAL part334 Summit Pharmaceuticals DOCUSATE SODIUM 100 mg/5mL N 20181231 17433-9991_603cf1a5-0686-b45a-e053-2a91aa0a46ab 17433-9991 HUMAN OTC DRUG CVS Adult Enema docusate sodium w/benzocaine LIQUID RECTAL 20140901 OTC MONOGRAPH NOT FINAL part334 Summit Pharmaceuticals DOCUSATE SODIUM; BENZOCAINE 283; 20 mg/4.6g; mg/4.6g N 20181231 17452-360_c131edbc-8f71-4da5-9029-68405eb218e9 17452-360 HUMAN OTC DRUG MDSolarSciences SPF40 Ultra-Sport Meradimate and Octisalate and Octocrylene and Titanium Dioxide and Zinc Oxide STICK TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Ecometics, Inc MERADIMATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE .35; .35; 1; .135; 1.025 g/10g; g/10g; g/10g; g/10g; g/10g E 20171231 17452-370_26e47ef7-264d-4664-b54c-d67483b0a0e4 17452-370 HUMAN OTC DRUG MDSolarSciences SPF40 No Touch Body Avobenzone and Octisalate and Octocrylene SPRAY TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Ecometics, Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 2.75 g/100mL; g/100mL; g/100mL E 20171231 17452-380_f1e2b580-adac-4eb6-b736-0cfb31f8326b 17452-380 HUMAN OTC DRUG MDSolarSciences SPF50 Plus Ultra Mineral Screen Titanium Dioxide and Zinc Oxide GEL TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Ecometics, Inc TITANIUM DIOXIDE; ZINC OXIDE 10.3; 5.5 g/100g; g/100g E 20171231 17452-390_e0762b81-4af2-4c37-9bb6-76a1b0b21a3f 17452-390 HUMAN OTC DRUG MDSolarSciences SPF30 Plus Mineral Screen Titanium Dioxide and Zinc Oxide GEL TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Ecometics, Inc TITANIUM DIOXIDE; ZINC OXIDE 7.7; 3.8 g/100g; g/100g E 20171231 17452-400_3a8fe4da-d828-4e57-96a6-4bbc0d99e514 17452-400 HUMAN OTC DRUG MDSolarSciences SPF40 Mineral Screen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Ecometics, Inc TITANIUM DIOXIDE; ZINC OXIDE 7.7; 3.8 g/100g; g/100g E 20171231 17452-430_bf08608c-f821-4594-8d03-de3f59c5521c 17452-430 HUMAN OTC DRUG Dr. OH BALM CAMPHOR, CAPSAICIN and MENTHOL CREAM TOPICAL 20120423 OTC MONOGRAPH NOT FINAL part348 Ecometics, Inc. MENTHOL; CAMPHOR (SYNTHETIC); CAPSAICIN 1; 3.5; .015 g/100g; g/100g; g/100g E 20171231 17478-012_92bcdb0e-3234-4cb7-9a35-732156fab340 17478-012 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20120808 NDA AUTHORIZED GENERIC NDA012015 Akorn, Inc. BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 17478-014_03519ae4-0c72-4acf-a759-f992f7b10273 17478-014 HUMAN PRESCRIPTION DRUG Sodium Nitroprusside Sodium Nitroprusside INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170504 ANDA ANDA208635 Akorn, Inc. SODIUM NITROPRUSSIDE 50 mg/2mL Vasodilation [PE],Vasodilator [EPC] N 20181231 17478-017_0bc0553a-b11a-4758-b53f-b61985cf7ef5 17478-017 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20160609 ANDA ANDA206634 Akorn, Inc. TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20191231 17478-018_0b63617b-a1f0-4246-a0be-c6cca7838aa1 17478-018 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20170928 ANDA ANDA206594 Akorn, Inc. TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 17478-030_4467bf8e-38ae-4e88-98a5-27007c753029 17478-030 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120322 NDA NDA016619 Akorn, Inc. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 17478-031_4467bf8e-38ae-4e88-98a5-27007c753029 17478-031 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE FENTANYL CITRATE INJECTION, SOLUTION INTRAVENOUS 20170710 NDA NDA016619 Akorn, Inc. FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 17478-033_97d47532-335f-4063-ba0c-cb25ee138b23 17478-033 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION, SOLUTION INTRAVENOUS 20171017 ANDA ANDA207692 Akorn, Inc. PARICALCITOL 5 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 17478-040_bf3566e9-f17f-43c1-971a-4d127d66e0f1 17478-040 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR 19800701 ANDA ANDA075025 Akorn, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 17478-041_b67ce40b-062a-481b-8dc4-736a17a4eb97 17478-041 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20170228 ANDA ANDA208871 Akorn, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20191231 17478-042_b67ce40b-062a-481b-8dc4-736a17a4eb97 17478-042 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20170314 ANDA ANDA208872 Akorn, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20191231 17478-045_7feb8936-1856-4478-804d-1e2280cb30ee 17478-045 HUMAN PRESCRIPTION DRUG Tetracaine Tetracaine HCl INJECTION SUBARACHNOID 20100601 UNAPPROVED DRUG OTHER Akorn, Inc. TETRACAINE HYDROCHLORIDE 10 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 17478-050_5385efa6-b861-4ff5-ab79-2997eb7abb3e 17478-050 HUMAN PRESCRIPTION DRUG Sufentanil Citrate Sufentanil Citrate INJECTION EPIDURAL; INTRAVENOUS 20101201 NDA NDA019050 Akorn, Inc. SUFENTANIL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 17478-055_3b91bc30-bb9c-43ca-9285-ece1b1058a97 17478-055 HUMAN PRESCRIPTION DRUG Dexmedetomidine Dexmedetomidine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20141124 ANDA ANDA202585 Akorn, Inc. DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 17478-060_0de3d6fa-dab6-4683-bceb-3adc856e5243 17478-060 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 19980301 OTC MONOGRAPH FINAL part349 Akorn, Inc. POLYVINYL ALCOHOL 14 mg/mL N 20181231 17478-062_a8145a3b-1d31-4069-974a-c81998336cb1 17478-062 HUMAN OTC DRUG Artificial Tears Mineral Oil and Petrolatum OINTMENT OPHTHALMIC 19900901 OTC MONOGRAPH FINAL part349 Akorn, Inc. MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g N 20181231 17478-063_1b32e063-96e1-489b-9638-466ea56afc63 17478-063 HUMAN OTC DRUG Lubricant Eye Mineral Oil and Petrolatum OINTMENT OPHTHALMIC 19930401 OTC MONOGRAPH FINAL part349 Akorn, Inc. MINERAL OIL; PETROLATUM 120; 880 mg/g; mg/g N 20181231 17478-064_6dfd4a1e-c9e3-4610-be06-a05ea5a6867b 17478-064 HUMAN PRESCRIPTION DRUG Gonak Hypromellose Hypromellose 2906 (4000 MPA.S) and Hypromellose 2906 (50 MPA.S) SOLUTION OPHTHALMIC 19970101 UNAPPROVED DRUG OTHER Akorn, Inc. HYPROMELLOSE 2906 (4000 MPA.S); HYPROMELLOSE 2906 (50 MPA.S) 25; 25 mg/mL; mg/mL N 20181231 17478-065_c9952204-fb64-42f5-8bb5-c18f325e0f30 17478-065 HUMAN OTC DRUG Naphazoline Hydrochloride and Pheniramine Maleate Naphazoline Hydrochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20130124 ANDA ANDA202795 Akorn, Inc. NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL N 20181231 17478-066_9496f818-72c7-400f-a6ee-77c851f0d320 17478-066 HUMAN PRESCRIPTION DRUG Nedocromil Sodium Nedocromil Sodium SOLUTION/ DROPS OPHTHALMIC 20120910 ANDA ANDA090638 Akorn, Inc. NEDOCROMIL SODIUM 20 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 17478-067_11ba2e00-8126-4e5b-a9b2-aeed654d5c20 17478-067 HUMAN PRESCRIPTION DRUG Alfentanil Hydrochloride Alfentanil Hydrochloride INJECTION INTRAVENOUS 20100201 NDA NDA019353 Akorn, Inc. ALFENTANIL HYDROCHLORIDE 500 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 17478-070_2a512501-d106-43ed-8491-b21824ad318c 17478-070 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 Akorn, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 17478-080_16c739d9-6b91-454e-acfd-b6122375ab5a 17478-080 HUMAN PRESCRIPTION DRUG CAPASTAT SULFATE Capreomycin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090801 NDA NDA050095 Akorn CAPREOMYCIN SULFATE 1 g/1 Antimycobacterial [EPC] N 20181231 17478-081_7fb73557-6021-45c5-9a04-387a2361d5a6 17478-081 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride Ropivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20160411 ANDA ANDA203955 Akorn, Inc. ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 17478-096_8a8f31e6-2216-43c9-8c95-43a52d7e6e4a 17478-096 HUMAN PRESCRIPTION DRUG Cyclopentolate Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20151210 ANDA ANDA205937 Akorn, Inc. CYCLOPENTOLATE HYDROCHLORIDE 5 mg/mL N 20181231 17478-097_4b3e7b47-d9d2-4c12-afb5-d42e2247608e 17478-097 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19970113 ANDA ANDA040165 Akorn, Inc. CYCLOPENTOLATE HYDROCHLORIDE 20 mg/mL N 20181231 17478-100_4b3e7b47-d9d2-4c12-afb5-d42e2247608e 17478-100 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19970113 ANDA ANDA040164 Akorn, Inc. CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL N 20181231 17478-101_42cf2e28-f9df-4dd6-88f9-ecad8522079c 17478-101 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 20000929 ANDA ANDA040314 Akorn, Inc. TROPICAMIDE 5 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 17478-102_42cf2e28-f9df-4dd6-88f9-ecad8522079c 17478-102 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 20000929 ANDA ANDA040315 Akorn, Inc. TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 17478-105_6fae6dd0-f626-456c-941b-730e673b4b5c 17478-105 HUMAN PRESCRIPTION DRUG Olopatadine Olopatadine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20170110 ANDA ANDA204532 Akorn, Inc. OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 17478-106_938be589-db2c-4612-ac1e-b47da326655b 17478-106 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin SOLUTION OPHTHALMIC 20110301 ANDA ANDA090268 Akorn Inc. LEVOFLOXACIN 5 mg/mL N 20181231 17478-107_fd88aa8b-37b6-4766-8cf9-21a9f63c548f 17478-107 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION INTRAVENOUS 20110701 ANDA ANDA091644 Akorn, Inc. LEVOFLOXACIN 25 mg/mL N 20181231 17478-110_f7d2863c-569d-4018-a17a-c0ae6e26cfb2 17478-110 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol Lactate INJECTION INTRAMUSCULAR 20170906 ANDA ANDA204849 Akorn, Inc. HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20191231 17478-114_e193bac8-1fac-4a2d-a13c-3e5336c86e60 17478-114 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140916 ANDA ANDA205179 Akorn, Inc. TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 17478-120_71cbc27c-bc8e-4e03-ba04-93866a22e7f5 17478-120 HUMAN PRESCRIPTION DRUG Clindamycin Clindamycin Phosphate INJECTION INTRAVENOUS 20130405 ANDA ANDA203048 Akorn, Inc. CLINDAMYCIN PHOSPHATE 300 mg/50mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 17478-121_71cbc27c-bc8e-4e03-ba04-93866a22e7f5 17478-121 HUMAN PRESCRIPTION DRUG Clindamycin Clindamycin Phosphate INJECTION INTRAVENOUS 20130405 ANDA ANDA203048 Akorn, Inc. CLINDAMYCIN PHOSPHATE 600 mg/50mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 17478-122_71cbc27c-bc8e-4e03-ba04-93866a22e7f5 17478-122 HUMAN PRESCRIPTION DRUG Clindamycin Clindamycin Phosphate INJECTION INTRAVENOUS 20130405 ANDA ANDA203048 Akorn, Inc. CLINDAMYCIN PHOSPHATE 900 mg/50mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 17478-151_98e1676c-27db-45bc-a592-dc16d19e3e8a 17478-151 HUMAN PRESCRIPTION DRUG Rifampin Rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120601 ANDA ANDA065502 AKORN, Inc. RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 17478-171_2644fc5e-91bd-4ba8-818b-845d5b08f465 17478-171 HUMAN PRESCRIPTION DRUG Xopenex Levalbuterol Hydrochloride SOLUTION, CONCENTRATE RESPIRATORY (INHALATION) 20150226 NDA NDA020837 Akorn, Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 17478-172_02f1a5b7-d560-47be-97b2-c9bc46d312f4 17478-172 HUMAN PRESCRIPTION DRUG Xopenex Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20150227 NDA NDA020837 Akorn, Inc. LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 17478-173_02f1a5b7-d560-47be-97b2-c9bc46d312f4 17478-173 HUMAN PRESCRIPTION DRUG Xopenex Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20150227 NDA NDA020837 Akorn, Inc. LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 17478-174_02f1a5b7-d560-47be-97b2-c9bc46d312f4 17478-174 HUMAN PRESCRIPTION DRUG Xopenex Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20150227 NDA NDA020837 Akorn, Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 17478-201_f541e39a-6a45-4fa1-90fb-69673fd86bb5 17478-201 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20150115 NDA NDA207926 Akorn, Inc. PHENYLEPHRINE HYDROCHLORIDE 25 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] N 20181231 17478-206_f541e39a-6a45-4fa1-90fb-69673fd86bb5 17478-206 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20150115 NDA NDA207926 Akorn, Inc. PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] N 20181231 17478-207_dede95b4-f1a0-476a-85e9-a28c33c8f0c4 17478-207 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION/ DROPS OPHTHALMIC 20140210 ANDA ANDA203376 Akorn KETOROLAC TROMETHAMINE 4.5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 17478-208_60d516c6-231e-43c1-bdd8-7fab0e116f0a 17478-208 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078399 Akorn Inc. KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 17478-209_3796fdae-b84c-4a3f-9b7e-d0d486ddc2fd 17478-209 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078434 Akorn Inc. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 17478-215_b9d7003c-5a44-45d1-bfdd-620fe17ecf9b 17478-215 HUMAN PRESCRIPTION DRUG Atropine Atropine Sulfate SOLUTION/ DROPS OPHTHALMIC 20140718 NDA NDA206289 Akorn, Inc. ATROPINE SULFATE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 17478-217_f2e54c3f-9ec7-4528-af3e-7af4f3c17f78 17478-217 HUMAN PRESCRIPTION DRUG TRANEXAMIC ACID Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20150309 ANDA ANDA202373 Akorn, Inc. TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 17478-221_f1769ef3-01ed-41b8-8b30-5741c4caba39 17478-221 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SOLUTION/ DROPS OPHTHALMIC 20140911 ANDA ANDA040215 Akorn, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 17478-223_6bbc3e5f-e208-4a24-b002-217e2a35c588 17478-223 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20170928 ANDA ANDA204398 Akorn, Inc. PILOCARPINE HYDROCHLORIDE 10 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 17478-224_6bbc3e5f-e208-4a24-b002-217e2a35c588 17478-224 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20170928 ANDA ANDA204398 Akorn, Inc. PILOCARPINE HYDROCHLORIDE 20 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 17478-226_6bbc3e5f-e208-4a24-b002-217e2a35c588 17478-226 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20170928 ANDA ANDA204398 Akorn, Inc. PILOCARPINE HYDROCHLORIDE 40 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 17478-235_4eab8228-b099-42e7-9d54-21bbe174520c 17478-235 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Neomycin Sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19900930 ANDA ANDA065088 Akorn, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] N 20181231 17478-238_966a8af1-d3e1-4bfd-aab8-ebcc1fded510 17478-238 HUMAN PRESCRIPTION DRUG AK-POLY-BAC Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 20060508 ANDA ANDA064028 Akorn, Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 17478-242_f1769ef3-01ed-41b8-8b30-5741c4caba39 17478-242 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SOLUTION/ DROPS OPHTHALMIC 20140911 ANDA ANDA040216 Akorn, Inc. SULFACETAMIDE SODIUM 300 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 17478-250_2e04a625-512e-4c19-a546-f164c363ad19 17478-250 HUMAN PRESCRIPTION DRUG AK-FLUOR fluorescein sodium INJECTION INTRAVENOUS 20081001 NDA NDA022186 Akorn FLUORESCEIN SODIUM 250 mg/mL Diagnostic Dye [EPC],Dyes [MoA] N 20191231 17478-253_2e04a625-512e-4c19-a546-f164c363ad19 17478-253 HUMAN PRESCRIPTION DRUG AK-FLUOR fluorescein sodium INJECTION INTRAVENOUS 20081001 NDA NDA022186 Akorn FLUORESCEIN SODIUM 100 mg/mL Diagnostic Dye [EPC],Dyes [MoA] N 20191231 17478-260_53954d56-d19b-4794-a0db-61ccc3469e3b 17478-260 HUMAN PRESCRIPTION DRUG Norgestimate and Ethinyl Estradiol Norgestimate and Ethinyl Estradiol KIT ORAL 20161115 ANDA ANDA200384 Akorn, Inc. N 20181231 17478-261_53954d56-d19b-4794-a0db-61ccc3469e3b 17478-261 HUMAN PRESCRIPTION DRUG Norgestimate and Ethinyl Estradiol Norgestimate and Ethinyl Estradiol KIT ORAL 20161115 ANDA ANDA200383 Akorn, Inc. N 20181231 17478-263_e3b72beb-a59f-42a3-adc3-a975fd7afd55 17478-263 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20000316 ANDA ANDA040277 Akorn, Inc. PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] N 20181231 17478-283_b7ae8fd7-cbcc-467a-85e8-91d5f194b3bb 17478-283 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20061213 ANDA ANDA064163 Akorn, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 17478-284_53b958b7-3b8f-4254-8a1f-5f61128a441b 17478-284 HUMAN PRESCRIPTION DRUG Gentak Gentamicin Sulfate OINTMENT OPHTHALMIC 20060508 ANDA ANDA064093 Akorn, Inc. GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 17478-288_47c38e05-d470-46fb-8cc0-504bfa275871 17478-288 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20120326 ANDA ANDA074466 Akorn, Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 17478-289_47c38e05-d470-46fb-8cc0-504bfa275871 17478-289 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20120326 ANDA ANDA074465 Akorn, Inc. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 17478-290_056bb631-b252-48a5-bc83-a57c722da426 17478-290 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064096 Akorn, Inc. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 17478-291_0f5882c2-977e-4f57-92a6-021a18152a8d 17478-291 HUMAN PRESCRIPTION DRUG Cromolyn Sodium Cromolyn Sodium SOLUTION/ DROPS OPHTHALMIC 19980429 ANDA ANDA074706 Akorn, Inc. CROMOLYN SODIUM 40 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 17478-305_47ac25fe-e6f0-4fb6-abbb-02f0a3773b55 17478-305 HUMAN PRESCRIPTION DRUG Olopatadine Olopatadine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20171205 ANDA ANDA204723 Akorn, Inc. OLOPATADINE HYDROCHLORIDE 2 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 17478-307_e6fd3055-d577-47d0-8606-1363423c3dca 17478-307 HUMAN PRESCRIPTION DRUG AzaSITE Azithromycin Monohydrate SOLUTION/ DROPS OPHTHALMIC 20140514 NDA NDA050810 Akorn, Inc. AZITHROMYCIN MONOHYDRATE 10 mg/mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 17478-324_4b3a01c5-8195-48d2-9c86-b13d0193381c 17478-324 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid SOLUTION INTRAVENOUS 20140821 ANDA ANDA200918 Akorn, Inc. ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 17478-327_148367aa-45c2-4157-abe8-0f28404b94df 17478-327 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140522 ANDA ANDA202548 Akorn ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 17478-340_a8ed1f64-a845-4803-a6c9-ee7ddc035211 17478-340 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION ORAL 20140529 ANDA ANDA201422 Akorn, Inc. TOBRAMYCIN 300 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 17478-365_b60501f2-7075-4e5a-a196-61a1889ac041 17478-365 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol SOLUTION/ DROPS OPHTHALMIC 20160930 ANDA ANDA205309 Akorn, Inc. TIMOLOL 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 17478-366_b60501f2-7075-4e5a-a196-61a1889ac041 17478-366 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol SOLUTION/ DROPS OPHTHALMIC 20160930 ANDA ANDA205309 Akorn, Inc. TIMOLOL 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 17478-380_44e73838-0213-48df-99fc-14210d9df72d 17478-380 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20171030 ANDA ANDA208306 Akorn, Inc. METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 17478-403_91f37154-901e-404f-9fb2-311bc4077fb5 17478-403 HUMAN PRESCRIPTION DRUG FUL-GLO Fluorescein Sodium STRIP OPHTHALMIC 20040601 UNAPPROVED DRUG OTHER Akorn, Inc. D&C YELLOW NO. 8 .6 mg/1 Diagnostic Dye [EPC],Dyes [MoA] E 20171231 17478-404_77814317-75f7-4b58-87e7-0fb7508b9b07 17478-404 HUMAN PRESCRIPTION DRUG FUL-GLO Fluorescein Sodium STRIP OPHTHALMIC 20040601 UNAPPROVED DRUG OTHER Akorn, Inc. D&C YELLOW NO. 8 1 mg/1 Diagnostic Dye [EPC],Dyes [MoA] E 20171231 17478-415_8e3f1920-591c-4346-815f-7400e173822b 17478-415 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION INTRAVENOUS 20170301 NDA NDA208609 Akorn, Inc. EPHEDRINE SULFATE 50 mg/mL alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE] N 20181231 17478-419_57200180-5ce6-41c8-a45a-d36c89a0760e 17478-419 HUMAN PRESCRIPTION DRUG Chlorothiazide Sodium Chlorothiazide Sodium INJECTION INTRAVENOUS 20120813 NDA AUTHORIZED GENERIC NDA011145 Akorn, Inc. CHLOROTHIAZIDE SODIUM 500 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 17478-420_06e6bcd8-82e4-4321-94cd-4e3eb7fe56e2 17478-420 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20040901 ANDA ANDA075431 Akorn, Inc. LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 17478-422_5b338083-97a7-479e-ab20-fbc9da945c1e 17478-422 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170228 ANDA ANDA204043 Akorn, Inc. MYCOPHENOLATE MOFETIL 500 mg/20mL Antimetabolite Immunosuppressant [EPC] N 20191231 17478-450_f5f39630-e597-4e13-a6a3-e670c7510d42 17478-450 HUMAN PRESCRIPTION DRUG Lortab Hydrocodone Bitartrate and Acetaminophen SYRUP ORAL 20150317 ANDA ANDA040881 Akorn, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 17478-501_5cc8f810-1754-48d0-9e85-c6cc0e734262 17478-501 HUMAN PRESCRIPTION DRUG Methylergonovine Maleate Methylergonovine Maleate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110302 ANDA ANDA040889 Akorn, Inc. METHYLERGONOVINE MALEATE .2 mg/mL Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] E 20171231 17478-503_588e1b45-95bd-4c9f-8295-54fd9aead63d 17478-503 HUMAN PRESCRIPTION DRUG Dehydrated Alcohol Alcohol INJECTION INTRASPINAL 19970201 UNAPPROVED DRUG OTHER Akorn, Inc. ALCOHOL .98 mL/mL N 20181231 17478-504_428b773b-da43-4e6f-830f-c8b83b7bfa3c 17478-504 HUMAN PRESCRIPTION DRUG Methylene Blue Methylene Blue INJECTION INTRAVENOUS 20090401 UNAPPROVED DRUG OTHER Akorn, Inc. METHYLENE BLUE 10 mg/mL Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 17478-510_3a576ece-66b9-4994-9c66-bbfeda96f797 17478-510 HUMAN PRESCRIPTION DRUG Physostigmine Salicylate Physostigmine Salicylate INJECTION INTRAVENOUS 20100810 UNAPPROVED DRUG OTHER Akorn PHYSOSTIGMINE SALICYLATE 1 mg/mL N 20181231 17478-514_2d4c870f-5839-444d-af07-6e9b93c97997 17478-514 HUMAN PRESCRIPTION DRUG Dorzolamide HCl and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20140922 ANDA ANDA203058 Akorn, Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 17478-515_c6d186e1-72f1-44e3-ae53-a45df5bf8f59 17478-515 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20090401 UNAPPROVED DRUG OTHER Akorn, Inc. EPHEDRINE SULFATE 50 mg/mL alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE] N 20181231 17478-517_8e3f1920-591c-4346-815f-7400e173822b 17478-517 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION INTRAVENOUS 20170301 NDA NDA208609 Akorn, Inc. EPHEDRINE SULFATE 50 mg/mL alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE] N 20181231 17478-519_162b4194-dc33-4c1c-88fb-656547e30fa6 17478-519 HUMAN PRESCRIPTION DRUG Moxifloxacin Moxifloxacin SOLUTION/ DROPS OPHTHALMIC 20171109 ANDA ANDA202916 Akorn, Inc. MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 17478-523_c904abad-bfc6-4bd2-b6be-fee22db6b272 17478-523 HUMAN PRESCRIPTION DRUG Midazolam Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20050506 ANDA ANDA075494 Akorn, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 17478-524_c904abad-bfc6-4bd2-b6be-fee22db6b272 17478-524 HUMAN PRESCRIPTION DRUG Midazolam Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20050506 ANDA ANDA075494 Akorn, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 17478-526_0a36b04d-0335-4df3-a700-18f4c29234b3 17478-526 HUMAN PRESCRIPTION DRUG BAL DIMERCAPROL INJECTION INTRAMUSCULAR 20120501 NDA NDA005939 Akorn, Inc. DIMERCAPROL 100 mg/mL Metal Chelating Activity [MoA],Metal Chelator [EPC] N 20181231 17478-538_7ca7bdb4-2a00-4d7a-a049-4b70ec11c8a1 17478-538 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate INJECTION INTRAMUSCULAR; INTRAVENOUS 20061017 ANDA ANDA040484 Akorn, Inc. ORPHENADRINE CITRATE 30 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 17478-540_38bdd5b6-412e-4cb8-b80e-018a12b98b23 17478-540 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride INJECTION PARENTERAL 20100515 ANDA ANDA078228 Akorn, Inc. HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 17478-542_c49e53a3-9b45-4280-8653-26327b678a50 17478-542 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20110315 ANDA ANDA078076 Akorn, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 17478-544_2cd47dfa-7fc9-4e0b-88bb-f825aa3d7ce8 17478-544 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20141002 ANDA ANDA090450 Akorn, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 17478-546_c8bec768-f4ad-4a98-87ef-2ca473dd9c9e 17478-546 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride INJECTION INTRAVENOUS 20091001 ANDA ANDA079078 Akorn, Inc. GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 17478-547_c8bec768-f4ad-4a98-87ef-2ca473dd9c9e 17478-547 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride INJECTION INTRAVENOUS 20091001 ANDA ANDA079119 Akorn, Inc. GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 17478-560_df0f9541-2fbe-4017-a2ea-e5c6f7a3819a 17478-560 HUMAN PRESCRIPTION DRUG Hydase Hyaluronidase INJECTION, SOLUTION INFILTRATION; INTERSTITIAL; INTRAMUSCULAR; INTRAOCULAR; RETROBULBAR; SUBCUTANEOUS 20151105 NDA NDA021716 Akorn, Inc. HYALURONIDASE 150 [USP'U]/mL Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] N 20181231 17478-604_70a066ff-3c89-4a61-9152-e8454e2a411c 17478-604 HUMAN PRESCRIPTION DRUG COSOPT PF Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20140514 NDA NDA202667 Akorn, Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 17478-605_27842f3b-c5c9-4a87-8420-b41d9f921bec 17478-605 HUMAN PRESCRIPTION DRUG COSOPT Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20140430 NDA NDA020869 Akorn DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 17478-608_efc8db91-3470-4efd-8a45-87de528e8860 17478-608 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20171023 ANDA ANDA206719 Akorn, Inc. BACITRACIN A 5000 [USP'U]/mL N 20181231 17478-609_63586097-548c-4a97-b5ad-68f0e5f99b90 17478-609 HUMAN PRESCRIPTION DRUG ZIOPTAN tafluprost SOLUTION/ DROPS OPHTHALMIC 20141126 NDA NDA202514 Akorn, Inc. TAFLUPROST .0045 mg/.3mL Prostaglandin Analog [EPC],Prostaglandin Receptor Agonists [MoA],Increased Prostaglandin Activity [PE],Prostaglandins [Chemical/Ingredient] N 20181231 17478-620_fcc28c0f-36ec-43cb-9f93-bdf0984cc25b 17478-620 HUMAN OTC DRUG Eyewash Water SOLUTION OPHTHALMIC 20140601 NDA NDA022305 Akorn, Inc. WATER 929 g/946mL N 20191231 17478-622_d25c3c66-3424-4404-a969-de7c094b4e0a 17478-622 HUMAN OTC DRUG Sodium Chloride Sodium Chloride OINTMENT OPHTHALMIC 20060508 OTC MONOGRAPH FINAL part349 Akorn, Inc. SODIUM CHLORIDE 50 mg/g N 20181231 17478-623_f4ab05eb-c2f7-4505-975c-8b2d554cfd3a 17478-623 HUMAN OTC DRUG Sodium Chloride Sodium Chloride SOLUTION/ DROPS OPHTHALMIC 19980401 OTC MONOGRAPH FINAL part349 Akorn, Inc. SODIUM CHLORIDE 50 mg/mL N 20181231 17478-625_c5abe6f0-519b-4578-b6a3-d9765d2fb4e9 17478-625 HUMAN PRESCRIPTION DRUG LATANOPROST LATANOPROST SOLUTION/ DROPS OPHTHALMIC 20120701 ANDA ANDA090887 Akorn, Inc. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 17478-640_b63db481-5b90-4817-b2f9-940ba2473d0b 17478-640 HUMAN PRESCRIPTION DRUG FLURESS Fluorescein Sodium and Benoxinate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19950201 UNAPPROVED DRUG OTHER Akorn, Inc. FLUORESCEIN SODIUM; BENOXINATE HYDROCHLORIDE 2.5; 4 mg/mL; mg/mL Diagnostic Dye [EPC],Dyes [MoA] N 20181231 17478-660_ccd5f2d5-5934-49c2-b20a-34aeedaa0d2f 17478-660 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine INJECTION INTRAVENOUS 20150325 ANDA ANDA203173 Akorn, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 17478-701_c9dd326d-1efc-4287-836d-9b8afed9202d 17478-701 HUMAN PRESCRIPTION DRUG IC-Green indocyanine green KIT INTRAVENOUS 20070901 NDA NDA011525 Akorn, Inc. N 20191231 17478-703_8af1c9da-f68d-441f-8835-e1ccc002edbe 17478-703 HUMAN PRESCRIPTION DRUG Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate SOLUTION OPHTHALMIC 19981217 ANDA ANDA065006 Akorn, Inc. TRIMETHOPRIM SULFATE; POLYMYXIN B SULFATE 1; 10000 mg/mL; [USP'U]/mL Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 17478-704_4fbab481-2310-4cd5-ad2b-c5c636065ccc 17478-704 HUMAN PRESCRIPTION DRUG Paremyd Hydroxyamphetamine hydrobromide, tropicamide SOLUTION OPHTHALMIC 19920130 NDA NDA019261 Akorn, Inc. HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE 10; 2.5 mg/mL; mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 17478-705_d614d1d2-4f5e-43bf-bcf6-a5949bc19066 17478-705 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20030401 ANDA ANDA075386 Akorn, Inc. BETAXOLOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 17478-711_b24d5457-92e7-4545-b80b-7c0eb2ed0951 17478-711 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride JELLY TOPICAL 20030801 ANDA ANDA040433 Akorn, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 17478-713_bd2baa03-a145-4320-b7ca-d63f6343e9d6 17478-713 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20080701 ANDA ANDA076407 Akorn, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 17478-714_3fd72e34-a14f-40be-85a6-df3fe02b0441 17478-714 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20090724 ANDA ANDA076555 Akorn Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 17478-715_c2d7435f-8989-4c1f-af7d-b42d52cf952a 17478-715 HUMAN PRESCRIPTION DRUG Brimonidine Brimonidine Tartrate SOLUTION/ DROPS OPHTHALMIC 20060907 ANDA ANDA076439 Akorn, Inc. BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 17478-716_466fef71-8939-411f-abda-b923f4882ed8 17478-716 HUMAN PRESCRIPTION DRUG Apraclonidine Ophthalmic Apraclonidine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20090812 ANDA ANDA077764 Akorn Inc. APRACLONIDINE HYDROCHLORIDE 5 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 17478-717_7ab5cec5-69db-4481-8ea9-40f9cffa63dd 17478-717 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20071001 ANDA ANDA077958 Akorn, Inc. KETOTIFEN FUMARATE .35 mg/mL N 20181231 17478-718_76c2a98c-a4be-4435-9a03-4b663d3861e8 17478-718 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20161108 ANDA ANDA203660 Akorn, Inc. AZELASTINE HYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 17478-719_7287d1bf-efa3-4318-a6c3-857ef1b5455f 17478-719 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone OINTMENT OPHTHALMIC 20120725 ANDA ANDA065213 Akorn, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE 3.5; 10000; 400; 10 mg/g; [USP'U]/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 17478-741_c8b86829-06df-49da-82d9-f205ed284f08 17478-741 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride CAPSULE ORAL 20120409 ANDA ANDA065478 Akorn, Inc. VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 17478-742_c8b86829-06df-49da-82d9-f205ed284f08 17478-742 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride CAPSULE ORAL 20120409 ANDA ANDA065478 Akorn, Inc. VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 17478-761_8c067dc9-5bfd-4c27-bc5d-253f67d59635 17478-761 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20140620 ANDA ANDA079217 Akorn, Inc. DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 17478-762_8c067dc9-5bfd-4c27-bc5d-253f67d59635 17478-762 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20140620 ANDA ANDA079217 Akorn, Inc. DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 17478-763_8c067dc9-5bfd-4c27-bc5d-253f67d59635 17478-763 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20140620 ANDA ANDA079217 Akorn, Inc. DRONABINOL 10 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 17478-766_b02de863-67a1-4f59-a9a5-ddf975a7e955 17478-766 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20121004 ANDA ANDA200456 Akorn, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 17478-767_b02de863-67a1-4f59-a9a5-ddf975a7e955 17478-767 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20121004 ANDA ANDA200456 Akorn, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 17478-792_65e9c091-e6f2-4962-b16f-0f476cf5a93d 17478-792 HUMAN PRESCRIPTION DRUG Akten Lidocaine Hydrochloride GEL OPHTHALMIC 20081008 NDA NDA022221 Akorn, Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS 35 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 17478-811_867285c1-a591-4751-bff9-59aab9e7b820 17478-811 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride JELLY TOPICAL 20030801 ANDA ANDA040433 Akorn, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 17478-817_320e323f-a93c-4113-9793-4e891ede6f56 17478-817 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20131112 ANDA ANDA075086 Akorn, Inc. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 17478-824_545cdb8b-c94d-4cfc-828a-8cee51bbb04d 17478-824 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20130311 ANDA ANDA064030 Akorn, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 17478-826_b867ce0e-b674-4a85-ae00-d5d1ddfdd329 17478-826 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20130311 ANDA ANDA064163 Akorn, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 17478-827_ad8eb2f8-51f4-44a6-8684-159ff03003a7 17478-827 HUMAN PRESCRIPTION DRUG Gentak Gentamicin Sulfate OINTMENT OPHTHALMIC 20130311 ANDA ANDA064093 Akorn, Inc. GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 17478-831_a069917e-6d03-450e-bd37-3b83fd4f0271 17478-831 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol INJECTION INTRAVENOUS 20130322 ANDA ANDA078066 Akorn, Inc. CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 17478-834_1319c78d-4970-4c15-83a9-0e28d4856882 17478-834 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20130221 ANDA ANDA040730 Akorn, Inc. HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 17478-837_a0073823-56c0-4815-bce8-19794558ad2f 17478-837 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20130322 ANDA ANDA075086 Akorn, Inc. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 17478-840_45cffbf5-9212-4c14-9918-9e2a2dfef5d4 17478-840 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride JELLY TOPICAL 20130801 ANDA ANDA040433 Akorn, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 17478-841_ac8f38e3-cc5e-47ae-9118-d6596e69f0f6 17478-841 HUMAN PRESCRIPTION DRUG Alfentanil Alfentanil Hydrochloride INJECTION INTRAVENOUS 20130719 NDA NDA019353 Akorn, Inc. ALFENTANIL HYDROCHLORIDE 500 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 17478-850_b7b457da-a549-4261-8479-3bc22cfad5a2 17478-850 HUMAN PRESCRIPTION DRUG Esomeprazole Sodium Esomeprazole Sodium INJECTION INTRAVENOUS 20170306 ANDA ANDA207181 Akorn, Inc. ESOMEPRAZOLE SODIUM 40 mg/5mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 17478-892_08e78394-f61d-4c74-8e9e-ce8032678349 17478-892 HUMAN PRESCRIPTION DRUG Diclofenac Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20080501 ANDA ANDA077845 Akorn, Inc. DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 17478-902_cfabdc3a-978a-497b-846b-417a7618d94d 17478-902 HUMAN PRESCRIPTION DRUG Eptifibatide Eptifibatide INJECTION, SOLUTION INTRAVENOUS 20170418 ANDA ANDA204589 Akorn, Inc. EPTIFIBATIDE 2 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20191231 17478-903_cfabdc3a-978a-497b-846b-417a7618d94d 17478-903 HUMAN PRESCRIPTION DRUG Eptifibatide Eptifibatide INJECTION, SOLUTION INTRAVENOUS 20170418 ANDA ANDA204589 Akorn, Inc. EPTIFIBATIDE .75 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20191231 17478-911_0239697b-0d90-43f7-92be-4af4f7273c95 17478-911 HUMAN PRESCRIPTION DRUG Epinastine Epinastine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20170505 ANDA ANDA204055 Akorn, Inc. EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 17478-920_7a763507-bb84-469b-985a-f083120a717a 17478-920 HUMAN PRESCRIPTION DRUG BALANCED SALT Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate SOLUTION OPHTHALMIC 20060927 ANDA ANDA075503 Akorn, Inc. CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE .48; .3; .75; 3.9; 6.4; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 17478-921_eb93e983-2121-45e6-a8e0-82ad1ff3ab16 17478-921 HUMAN PRESCRIPTION DRUG Balanced Salt Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate and Trisodium Citrate Dihydrate SOLUTION OPHTHALMIC 20141127 ANDA ANDA075503 Akorn, Inc. SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE; TRISODIUM CITRATE DIHYDRATE 6.4; .75; .48; .3; 3.9; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 17478-931_f6ae2b95-8e3e-40fd-892a-d4a3f6cf7721 17478-931 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol INJECTION INTRAVENOUS 20111014 ANDA ANDA078066 Akorn, Inc. CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 17478-932_f6ae2b95-8e3e-40fd-892a-d4a3f6cf7721 17478-932 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol INJECTION INTRAVENOUS 20111014 ANDA ANDA078066 Akorn, Inc. CALCITRIOL 2 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 17478-933_452dcbc2-05fd-4ede-bb1b-be661eb85b31 17478-933 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate INJECTION SUBCUTANEOUS 20100201 ANDA ANDA078151 Akorn TERBUTALINE SULFATE 1 mg/mL N 20181231 17478-934_48c97360-2f88-4484-8619-34fa29b8dc34 17478-934 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20090501 ANDA ANDA040730 Akorn, Inc. HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 17478-937_9b50fc15-aef0-409d-8b78-7a9af7094df2 17478-937 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20061221 ANDA ANDA075086 Akorn, Inc. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 17478-953_c16710c3-5202-479e-9f2b-35045301c222 17478-953 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20171026 ANDA ANDA078076 Akorn, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 17478-955_2437eaa7-fb94-49f7-a842-ab46fc024ec6 17478-955 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION INTRAVENOUS 20171026 NDA NDA208609 Akorn, Inc. EPHEDRINE SULFATE 50 mg/mL alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE] N 20181231 17478-957_b62b0cbe-b21a-4d99-8ab1-43a3b7496265 17478-957 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171026 ANDA ANDA204043 Akorn, Inc. MYCOPHENOLATE MOFETIL 500 mg/20mL Antimetabolite Immunosuppressant [EPC] N 20181231 17478-987_32eac8c8-fcc9-4906-8e08-f97ca2eeacda 17478-987 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol INJECTION, SOLUTION INTRAVENOUS 20150508 ANDA ANDA203929 Akorn, Inc. DOXERCALCIFEROL 2 ug/mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 17478-988_32eac8c8-fcc9-4906-8e08-f97ca2eeacda 17478-988 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol INJECTION, SOLUTION INTRAVENOUS 20150508 ANDA ANDA203929 Akorn, Inc. DOXERCALCIFEROL 4 ug/2mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 17518-001_d3b72eb4-8b9b-4cbb-b2c4-1002840f3095 17518-001 HUMAN OTC DRUG Hand Sanitizer Ultrathon Ethyl Alcohol GEL TOPICAL 20120409 OTC MONOGRAPH FINAL part333A 3M Health Care ALCOHOL 62 g/100mL N 20181231 17518-002_c4d4dee3-d62c-4bd0-9aaf-57f0d8ff856b 17518-002 HUMAN OTC DRUG SPF 50 Broad Spectrum Ultrathon Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120409 OTC MONOGRAPH FINAL part352 3M Health Care AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 17518-003_2efff4ff-eb1d-4bc0-86d2-673ed3dc5f80 17518-003 HUMAN OTC DRUG Broad Spectrum SPF 30 Ultrathon Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LIQUID TOPICAL 20120425 OTC MONOGRAPH FINAL part352 3M Health Care AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 17518-004_a551fb6c-74b6-4e69-b1e1-133aa5dc9c0a 17518-004 HUMAN OTC DRUG SPF 50 Broad Spectrum Ultrathon Homosalate, Octinoxate, Octisalate, Octocrylene, Zinc Oxide STICK TOPICAL 20120409 OTC MONOGRAPH FINAL part352 3M Health Care ZINC OXIDE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OCTINOXATE 8; 6; 5; 10; 7.5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 17518-011_3119e6ab-190d-4bef-a1c4-5b6939802b9f 17518-011 HUMAN OTC DRUG 3M DuraPrep Surgical Iodine povacrylex and Isopropyl alcohol SOLUTION TOPICAL 20060929 NDA NDA021586 3M Health Care IODINE POVACRYLEX; ISOPROPYL ALCOHOL 6.02; 636.4 mg/mL; mg/mL E 20171231 17518-011_84765393-9ee7-4f2b-86e3-a8f309b29af0 17518-011 HUMAN OTC DRUG 3M DuraPrep Surgical Iodine povacrylex and Isopropyl alcohol SOLUTION TOPICAL 20060929 NDA NDA021586 3M Health Care IODINE POVACRYLEX; ISOPROPYL ALCOHOL 6.02; 636.4 mg/mL; mg/mL E 20171231 17518-028_a6ede7b3-8dc5-4912-be69-c5d69a3759a8 17518-028 HUMAN OTC DRUG 3M Cavilon Durable Barrier Fragrance Free Dimethicone CREAM TOPICAL 20110331 OTC MONOGRAPH FINAL part347 3M Health Care DIMETHICONE 13000 mg/L N 20181231 17518-030_1677d8d8-c4b3-4d21-a26f-b5937e45c23d 17518-030 HUMAN OTC DRUG 3M Cavilon Durable Barrier Dimethicone CREAM TOPICAL 20160601 OTC MONOGRAPH FINAL part347 3M Health Care DIMETHICONE 13000 mg/L N 20181231 17518-050_56177f7e-7f7f-44e7-bd49-bd632b7564a6 17518-050 HUMAN OTC DRUG 3M Avagard D Alcohol LOTION TOPICAL 19991001 OTC MONOGRAPH NOT FINAL part333E 3M Health Care ALCOHOL 530.7 mg/mL E 20171231 17518-051_5d8fee61-b0b2-4ad0-bb6a-cb1a6beb8d20 17518-051 HUMAN OTC DRUG 3M Avagard Chlorhexidine Gluconate and Alcohol LOTION TOPICAL 20010614 NDA NDA021074 3M Health Care CHLORHEXIDINE GLUCONATE; ALCOHOL 8.3; 506.3 mg/mL; mg/mL N 20181231 17518-053_209fa03b-397c-4055-8d1e-8b2fe73ef0a8 17518-053 HUMAN OTC DRUG 3M Avagard Foam Alcohol LIQUID TOPICAL 20070301 OTC MONOGRAPH NOT FINAL part333E 3M Health Care ALCOHOL 496 mg/mL E 20171231 17518-054_993cbe8c-adc5-41be-bfec-e5cdd44319ca 17518-054 HUMAN OTC DRUG 3M Nexcare Cold Sore Treatment 3M Nexcare Cold Sore Treatment OINTMENT TOPICAL 20080220 OTC MONOGRAPH NOT FINAL part348 3M Company BENZOCAINE; ALLANTOIN 50; 10 mg/g; mg/g E 20171231 17518-055_f57ac3ae-7352-4d9f-848e-835335631661 17518-055 HUMAN OTC DRUG 3M Avagard Foaming Instant Hand Antiseptic Alcohol LIQUID TOPICAL 20110527 OTC MONOGRAPH NOT FINAL part333E 3M Health Care ALCOHOL 548 mg/mL E 20171231 17518-056_fb2dd835-995e-432c-8269-8203856ca577 17518-056 HUMAN OTC DRUG 3M Avagard Instant Hand Antiseptic with Moisturizers Alcohol GEL TOPICAL 20130614 OTC MONOGRAPH NOT FINAL part333E 3M Health Care ALCOHOL 577.7 mg/mL E 20171231 17518-060_ddd2db12-e338-45c4-ad62-bb89e5f1a5ad 17518-060 HUMAN OTC DRUG 3M Skin and Nasal Antiseptic Povidone-Iodine SOLUTION TOPICAL 20090701 OTC MONOGRAPH NOT FINAL part333E 3M Health Care POVIDONE-IODINE 5 mg/mL N 20181231 17518-857_5db17e34-f83e-47d1-b04a-2668d105f3b8 17518-857 HUMAN OTC DRUG 3M Cavilon Antifungal miconazole nitrate CREAM TOPICAL 20101130 OTC MONOGRAPH FINAL part333C 3M Health Care MICONAZOLE NITRATE 2 g/1000g E 20171231 17575-001_c8bc75cd-c2d0-4ed4-a1d8-b7d2d525ead8 17575-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19660101 NDA NDA205767 AGL Inhalation Therapy Co. OXYGEN 990 mL/L N 20181231 17575-005_fcc9f3e0-ae8c-4088-a553-b120411b8b46 17575-005 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19660101 NDA NDA205851 AGL Inhalation Therapy Co. HELIUM 990 mL/L N 20181231 17575-006_96464e94-6d93-418e-9345-09e0a1b33e4e 17575-006 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19660101 NDA NDA205766 AGL Inhalation Therapy Co. NITROGEN 990 mL/L N 20181231 17575-007_39b5852e-684e-404b-9581-bb59080012a3 17575-007 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS AGL Inhalation Therapy Co. AIR 1000 mL/L E 20171231 17575-011_60abb053-96b2-4bda-e053-2991aa0a2990 17575-011 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19660101 NDA NDA206009 AGL Welding Supply Co., Inc. NITROUS OXIDE 990 mL/L N 20181231 17575-020_e22ce006-8aa8-47a7-8de8-761da9ada866 17575-020 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture 5/95 Carbon Dioxide Oxygen Mixture 5/95 GAS RESPIRATORY (INHALATION) 19660101 NDA NDA205767 AGL Inhalation Therapy Co. OXYGEN 950 mL/L N 20181231 17575-038_55b1f45d-4bcc-4be4-9c08-15f407af8ab6 17575-038 HUMAN PRESCRIPTION DRUG Oxygen Helium Mixture 30/70 Oxygen Helium Mixture 30/70 GAS RESPIRATORY (INHALATION) 19660101 NDA NDA205767 AGL Inhalation Therapy Co. OXYGEN 300 mL/L N 20181231 17575-104_45e0b79a-98cb-44cd-8a6f-322b31ba5d7c 17575-104 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19660101 NDA NDA205764 AGL Inhalation Therapy Co. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 17575-192_2e7907d8-feba-4982-8061-979c8ca4632e 17575-192 HUMAN PRESCRIPTION DRUG Oxygen Helium Mixture 20/80 Oxygen Helium Mixture 20/80 GAS RESPIRATORY (INHALATION) 19660101 NDA NDA205767 AGL Inhalation Therapy Co. OXYGEN 200 mL/L N 20181231 17575-300_614223a6-06e3-59b3-e053-2991aa0ac66d 17575-300 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19660101 NDA NDA205767 AGL Welding Supply Co., Inc. OXYGEN 210 mL/L N 20181231 17630-2000_3c007a4b-a0cb-4ab6-90e7-e564046c0475 17630-2000 HUMAN OTC DRUG New Hawaiian Tropic Sensitive Skin Lotion Sunscreen Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20091104 OTC MONOGRAPH NOT FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .08; .06 g/g; g/g; g/g N 20181231 17630-2001_d9c18759-a87f-481e-b69a-bbd7079d53f9 17630-2001 HUMAN OTC DRUG Banana Boat Baby Tear Free Sunscreen SPF 60 Homosalate and Octinoxate and Octisalate and Avobenzone and Octocrylene SPRAY TOPICAL 20091022 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE .15; .075; .05; .03; .024 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2002_9f025323-11fe-4dd4-9624-2c4a03815ab9 17630-2002 HUMAN OTC DRUG Banana Boat Kids Tear Free Sunscreen SPF 60 Homosalate and Octinoxate and Octisalate and Avobenzone and Octocrylene SPRAY TOPICAL 20091022 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE .15; .075; .05; .03; .024 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2003_0086e81b-d038-47fa-9d83-782fc54a7c06 17630-2003 HUMAN OTC DRUG Banana Boat UltraMist Baby Tear Free Continuous SPF 50 Avobenzone and Homosalate and Octinoxate and Octisalate and Octocrylene SPRAY TOPICAL 20091022 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .15; .075; .05; .024 g/g; g/g; g/g; g/g; g/g N 20181231 17630-2004_7c7eff48-33f8-4279-a8d2-67988618b4b0 17630-2004 HUMAN OTC DRUG Banana Boat Kids Tear Free Continuous SPF 50 Avobenzone and Homosalate and Octinoxate and Octisalate and Octocrylene SPRAY TOPICAL 20091022 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .03; .15; .075; .05; .024 g/g; g/g; g/g; g/g; g/g N 20181231 17630-2005_9d1cd011-8b7f-4167-8a70-5a6cd917af82 17630-2005 HUMAN OTC DRUG Banana Boat Sport Performance SPF 15 Avobenzone and Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone SPRAY TOPICAL 20061202 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .05; .05; .05; .025; .02 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2006_f665b5cc-971a-42d4-a47b-b91e69d5ab72 17630-2006 HUMAN OTC DRUG Banana Boat Baby Tear Free Lotion SPF 50 Homosalate and Octinoxate and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL 20090723 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE .1; .075; .05; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2007_7902a1cb-8398-4127-8feb-3270158cabed 17630-2007 HUMAN OTC DRUG Banana Boat UltraMist Kids Tear Free Lotion SPF 50 Homosalate and Octinoxate and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL 20090723 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE .1; .075; .05; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2008_615baf42-a82b-404d-a778-6099a96f4172 17630-2008 HUMAN OTC DRUG Banana Boat UltraMist Kids SPF 50 Factor de Proteccion Solar 50 Homosalate and Octinoxate and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL 20090723 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE .1; .075; .05; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2009_1f44e8e0-2175-45c3-9bd3-61aac7fa7f58 17630-2009 HUMAN OTC DRUG Banana Boat Kids Sin Lagrimas Pump SPF 50 Homosalate and Octinoxate and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL 20090723 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE .1; .075; .05; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2010_a602e76c-9dbe-491a-abe9-4178d1257ea8 17630-2010 HUMAN OTC DRUG Banana Boat Baby Sin Lagrimas SPF 50 Pump Homosalate and Octinoxate and Octisalate and Octocrylene and Avobenzone SPRAY TOPICAL 20090723 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE .1; .075; .05; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2011_00b22981-e6f4-43d7-a37e-a7d8ccf73a9b 17630-2011 HUMAN OTC DRUG Banana Boat Kids UltraMist Tear Free SPF 30 Avobenzone and Homosalate and Octisalate and Octocrylene SPRAY TOPICAL 20080618 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .03; .15; .05; .025 g/g; g/g; g/g; g/g N 20181231 17630-2012_c6c46da9-5c2d-4af5-a183-4c3627b93e5c 17630-2012 HUMAN OTC DRUG Banana Boat Protective Dry SPF 10 Homosalate and Octisalate and Octocrylene and Avobenzone OIL TOPICAL 20090701 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE .06; .06; .025; .015 mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2013_9bdf3d53-69c7-42f5-b5e8-21cbcdc40eee 17630-2013 HUMAN OTC DRUG Hawaiian Tropic Tanning Dry SPF 6 Avobenzone and Octocrylene and Oxybenzone OIL TOPICAL 20090520 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .005; .035; .015 mL/mL; mL/mL; mL/mL N 20181231 17630-2014_635e6e02-0003-42ef-882f-01df2ec0f540 17630-2014 HUMAN OTC DRUG Banana Boat Sport Performance SPF 85 Avobenzone and Homosalate and Octocrylene and Oxybenzone SPRAY TOPICAL 20090601 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .1; .06 mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2015_901b758c-9233-4d40-ac15-64487d1ceaca 17630-2015 HUMAN OTC DRUG Banana Boat Ultra Defense SPF 85 Avobenzone and Homosalate and Octocrylene and Oxybenzone SPRAY TOPICAL 20090601 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .1; .06 mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2016_ed38ed68-00e7-4b46-8f04-893bb4e9f4a9 17630-2016 HUMAN OTC DRUG Banana Boat Kids Protect and Play SPF 85 Avobenzone and Homosalate and Octocrylene and Oxybenzone SPRAY TOPICAL 20090601 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .1; .06 mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2017_d2e595d9-629c-4d9d-add3-e9c0d237b8ae 17630-2017 HUMAN OTC DRUG Banana Boat Protective Dry SPF 15 Avobenzone and Octocrylene and Oxybenzone OIL TOPICAL 20080717 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .05; .03 mL/mL; mL/mL; mL/mL N 20181231 17630-2018_2c23f218-5b62-4fee-a22a-b3f043c17ec1 17630-2018 HUMAN OTC DRUG Banana Boat Deep Tanning Dry SPF 8 Avobenzone and Octocrylene and Oxybenzone OIL TOPICAL 20080717 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .03; .03 mL/mL; mL/mL; mL/mL N 20181231 17630-2019_8765dc76-e236-49e9-a99c-de6d2da684b7 17630-2019 HUMAN OTC DRUG Banana Boat Deep Tanning Dry SPF 4 Avobenzone and Octocrylene and Oxybenzone OIL TOPICAL 20090916 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .005; .01; .005 mL/mL; mL/mL; mL/mL N 20181231 17630-2020_6704904c-0a25-438d-bebe-f1f10ad01672 17630-2020 HUMAN OTC DRUG Banana Boat Sport Body and Scalp SPF 30 Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone LOTION TOPICAL 20090609 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE .0878; .05; .05; .025; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2021_f497ea15-b04b-4dab-b492-4dcf2f28bfc2 17630-2021 HUMAN OTC DRUG Banana Boat Sport SPF 30 Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20090609 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE .0878; .05; .05; .025; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2022_fa29e200-6cd5-459e-858d-c04045d0ab04 17630-2022 HUMAN OTC DRUG Banana Boat Ultra Defence SPF 30 for UK Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20090609 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE .0878; .05; .05; .025; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2023_be23fe01-6d34-422a-b7be-33de1c8e4221 17630-2023 HUMAN OTC DRUG Banana Boat Ultra Defense SPF 30 for LATAM Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20090609 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE .0878; .05; .05; .025; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2024_5a121d3c-63ea-4574-a5b5-a7eee3eb6a26 17630-2024 HUMAN OTC DRUG Banana Boat Ultramist Sport Performance SPF 50 Octocrylene and Avobenzone and Octisalate and Oxybenzone and Octinoxate and Homosalate SPRAY TOPICAL 20090209 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE .0878; .075; .05; .025; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2025_ed658d67-77fd-4101-ae80-b31a4cf6b4d8 17630-2025 HUMAN OTC DRUG Banana Boat Aceite Bronceador Seco Tanning Dry SPF 6 Homosalate and Octisalate and Octocrylene and Avobenzone OIL TOPICAL 20090403 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE .04; .04; .025; .01 mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2026_9fdfa6f7-504a-4b57-8db1-e5d7c0667d53 17630-2026 HUMAN OTC DRUG Banana Boat Protective Dry SPF 6 Octocrylene and Oxybenzone and Avobenzone OIL TOPICAL 20090522 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. OCTOCRYLENE; OXYBENZONE; AVOBENZONE .03; .03; .01 mL/mL; mL/mL; mL/mL N 20181231 17630-2027_2142a0e1-ed1a-449e-a352-9f950fe4e792 17630-2027 HUMAN OTC DRUG Banana Boat Sport Performance SPF 30 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20090909 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .077; .03 mL/mL; mL/mL; mL/mL N 20181231 17630-2028_f7696695-e133-4cfe-bc72-4d800139a99f 17630-2028 HUMAN OTC DRUG Banana Boat Quik Dri Sport Body and Scalp SPF 30 Avobenzone and Octocrylene and Oxybenzone LOTION TOPICAL 20090909 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .077; .03 mL/mL; mL/mL; mL/mL N 20181231 17630-2029_a077d77a-717c-475e-b812-2ee0fa43be25 17630-2029 HUMAN OTC DRUG Banana Boat Ultra Defense Sheer Protect SPF 30 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20090909 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .077; .03 mL/mL; mL/mL; mL/mL N 20181231 17630-2030_07b667aa-e5ed-4964-ba8c-ee3ab41f05a5 17630-2030 HUMAN OTC DRUG Banana Boat Sport SPF 60 Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20090915 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. OCTOCRYLENE; OXYBENZONE; AVOBENZONE .1; .05; .03 mg/mL; mL/mL; mL/mL N 20181231 17630-2031_dd4a145a-af97-41bf-934e-0a536d79045e 17630-2031 HUMAN OTC DRUG Banana Boat Ultra Defense SPF 60 Canada Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20090915 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. OCTOCRYLENE; OXYBENZONE; AVOBENZONE .1; .05; .03 mL/mL; mL/mL; mL/mL N 20181231 17630-2032_329a8aca-13b0-4990-89bd-48e69e60ffba 17630-2032 HUMAN OTC DRUG Banana Boat Sport SPF 50 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20090915 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .1; .05 mL/mL; mL/mL; mL/mL N 20181231 17630-2033_7edaa698-1afd-4f83-af48-2895d699c038 17630-2033 HUMAN OTC DRUG Banana Boat Ultra Defense Sheer Protect SPF 50 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20090915 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .1; .05 mL/mL; mL/mL; mL/mL N 20181231 17630-2034_ac21efca-d5d1-4948-946f-91467f008ded 17630-2034 HUMAN OTC DRUG Banana Boat Kids Protect and Play SPF 50 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20090915 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .03; .1; .05 mL/mL; mL/mL; mL/mL N 20181231 17630-2035_a4e3211d-f25b-4e3e-b39d-028de892f165 17630-2035 HUMAN OTC DRUG Hawaiian Tropic Island Sport SPF 30 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20091003 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .077; .03 mL/mL; mL/mL; mL/mL N 20181231 17630-2036_6f5f36d2-72b7-435d-9395-e0b961e19f24 17630-2036 HUMAN OTC DRUG Hawaiian Tropic Kids SPF 30 Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20091003 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE .01; .077; .03 mL/mL; mL/mL; mL/mL N 20181231 17630-2037_8d5b7e87-1323-4ea5-9a9b-434ba6c8f2f2 17630-2037 HUMAN OTC DRUG Hawaiian Tropic Sheer Touch SPF 30 Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20091003 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. OCTOCRYLENE; OXYBENZONE; AVOBENZONE .077; .03; .01 mL/mL; mL/mL; mL/mL N 20181231 17630-2038_e0df89ba-63cb-424c-9ead-a1188320a0ce 17630-2038 HUMAN OTC DRUG Hawaiian Tropic Island Sport SPF 30 for Canada Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20091003 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. OCTOCRYLENE; OXYBENZONE; AVOBENZONE .077; .03; .01 mL/mL; mL/mL; mL/mL N 20181231 17630-2039_eaf7f800-8986-43b1-9a61-ba9e2ed366ed 17630-2039 HUMAN OTC DRUG Hawaiian Tropic Carrot Protective Oil SPF 30 Octocrylene and Oxybenzone and Avobenzone OIL TOPICAL 20091215 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. OCTOCRYLENE; OXYBENZONE; AVOBENZONE .077; .03; .02 mL/mL; mL/mL; mL/mL N 20181231 17630-2040_d7b8f27e-e6c1-49e3-aaf5-89b61baa8a2e 17630-2040 HUMAN OTC DRUG Banana Boat Sport Performance SPF 30 Canada Homosalate and Octinoxate and Octisalate and Oxybenzone and Avobenzone and Octocrylene SPRAY TOPICAL 20100102 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE .0878; .05; .05; .05; .03; .025 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2041_b862a610-f3db-4809-9a68-64e7cb0d2748 17630-2041 HUMAN OTC DRUG Banana Boat Ultra Defense SPF 30 Canada Homosalate and Octinoxate and Octisalate and Oxybenzone and Avobenzone and Octocrylene SPRAY TOPICAL 20100102 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE .0878; .05; .05; .05; .03; .025 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2042_e7ede41e-8d88-4c4f-a3d4-bf313ba4f3d6 17630-2042 HUMAN OTC DRUG Banana Boat Sport Performance SPF 15 Canada Homosalate and Octinoxate and Octisalate and Avobenzone and Octocrylene and Oxybenzone SPRAY TOPICAL 20090914 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE; OXYBENZONE .05; .05; .05; .03; .025; .02 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2043_b4aebf76-9b82-4a6b-9189-fcafdecbd758 17630-2043 HUMAN OTC DRUG Banana Boat Ultra defense SPF 50 Canada Homosalate and Octinoxate and Octisalate and Oxybenzone and Avobenzone and Octocrylene SPRAY TOPICAL 20090914 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE .0878; .075; .05; .05; .03; .025 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2044_48c3ba2a-bd4b-4426-98b4-5622274eab56 17630-2044 HUMAN OTC DRUG Banana Boat Ultra Defense Sheer Protect FPS 50 LATAM Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20100315 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE .0878; .075; .05; .025; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17630-2045_289b4459-15ba-45f6-b571-51559b4b2d2e 17630-2045 HUMAN OTC DRUG Banana Boat Ultra Mist Kids FPS 60 LATAM Homosalate and Octinoxate and Octisalate and Octocrylene and Oxybenzone and Avobenzone SPRAY TOPICAL 20100309 OTC MONOGRAPH FINAL part352 Accra-Pac, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE .1; .075; .05; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL N 20181231 17714-009_655159bb-d283-4504-ad3f-562f8ba85782 17714-009 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19880415 OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ASPIRIN 81 mg/1 N 20181231 17714-010_5cc8b5f1-4ae4-471b-e053-2991aa0a84c1 17714-010 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20020109 OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ASPIRIN 325 mg/1 N 20181231 17714-011_5cc9070d-57cd-a48a-e053-2a91aa0a449e 17714-011 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19900508 OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ASPIRIN 325 mg/1 N 20181231 17714-012_60f41580-e068-faad-e053-2a91aa0a9076 17714-012 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 19890205 OTC MONOGRAPH NOT FINAL part343 Advance Pharmaceutical Inc. ACETAMINOPHEN 325 mg/1 N 20181231 17714-013_60f41580-e099-faad-e053-2a91aa0a9076 17714-013 HUMAN OTC DRUG APAP Acetaminophen TABLET ORAL 19890205 OTC MONOGRAPH NOT FINAL part343 Advance Pharmaceutical Inc. ACETAMINOPHEN 500 mg/1 N 20181231 17714-014_60f41580-e0a5-faad-e053-2a91aa0a9076 17714-014 HUMAN OTC DRUG APAP Acetaminophen TABLET ORAL 19900114 OTC MONOGRAPH NOT FINAL part343 Advance Pharmaceutical Inc. ACETAMINOPHEN 500 mg/1 N 20181231 17714-016_5cc9196c-68c7-c9c1-e053-2a91aa0acd8b 17714-016 HUMAN OTC DRUG Anti Allergy Chlorpheniramine Maleate TABLET ORAL 20020109 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 17714-019_7bf77325-4a8a-4763-89a1-bd82f1838f8f 17714-019 HUMAN OTC DRUG GAS RELIEF Simethicone TABLET, CHEWABLE ORAL 19991104 OTC MONOGRAPH FINAL part332 Advance Pharmaceutical Inc. DIMETHICONE 80 mg/1 N 20181231 17714-020_60f4322f-5ca5-096a-e053-2a91aa0a64eb 17714-020 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 19890912 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 17714-021_60f41580-e0b1-faad-e053-2a91aa0a9076 17714-021 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 19891005 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 17714-023_5cc9196c-68d7-c9c1-e053-2a91aa0acd8b 17714-023 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride TABLET ORAL 20120901 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 17714-025_60f41580-e08d-faad-e053-2a91aa0a9076 17714-025 HUMAN OTC DRUG ANTACID Calcium Carbonate TABLET ORAL 19900406 OTC MONOGRAPH FINAL part331 Advance Pharmaceutical Inc. CALCIUM CARBONATE 648 mg/1 N 20181231 17714-040_60f4322f-5cc1-096a-e053-2a91aa0a64eb 17714-040 HUMAN OTC DRUG Simethicone Simethicone TABLET, CHEWABLE ORAL 20121101 OTC MONOGRAPH FINAL part332 Advance Pharmaceutical Inc. DIMETHICONE 125 mg/1 N 20181231 17714-041_fd016912-6560-449a-bfbc-e5e522b7ceee 17714-041 HUMAN OTC DRUG ANTACID Calcium Carbonate TABLET, CHEWABLE ORAL 20071130 OTC MONOGRAPH FINAL part331 Advance Pharmaceutical Inc. CALCIUM CARBONATE 500 mg/1 N 20181231 17714-043_b43c92b6-7139-4efa-bd71-3c4cc35d3dd8 17714-043 HUMAN OTC DRUG ANTACID Calcium Carbonate TABLET, CHEWABLE ORAL 19960126 OTC MONOGRAPH FINAL part331 Advance Pharmaceutical Inc. CALCIUM CARBONATE 500 mg/1 N 20181231 17714-045_60f4322f-5cb1-096a-e053-2a91aa0a64eb 17714-045 HUMAN OTC DRUG Pepto Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20020109 OTC MONOGRAPH FINAL part335 Advance Pharmaceutical Inc. BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 17714-077_e71c431d-e798-4320-aa9d-5c8da4463c30 17714-077 HUMAN OTC DRUG Polysaccharide-Iron Polysaccharide-Iron CAPSULE ORAL 20150526 UNAPPROVED DRUG OTHER Advance Pharmaceutical Inc. IRON 150 mg/1 N 20181231 17714-115_5cc96295-eaf6-1c2a-e053-2a91aa0a18b3 17714-115 HUMAN OTC DRUG Meclizine HCL Meclizine HCl 25mg Chewable Tablets TABLET, CHEWABLE ORAL 20130701 OTC MONOGRAPH FINAL part336 Advance Pharmaceutical Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 17714-117_5cc9755e-6d41-fa9f-e053-2991aa0afbef 17714-117 HUMAN OTC DRUG Meclizine HCL 12.5 mg Meclizine HCL 12.5 mg TABLET ORAL 20130701 OTC MONOGRAPH FINAL part336 Advance Pharmaceutical Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 17714-121_5cc8bd8c-1d8c-180b-e053-2a91aa0ac490 17714-121 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19990612 OTC MONOGRAPH FINAL part343 Advance Pharmaceutical Inc. ASPIRIN 81 mg/1 N 20181231 17714-122_5cc98885-35c9-38b3-e053-2991aa0a8f76 17714-122 HUMAN OTC DRUG Senna Sennosides TABLET ORAL 20170201 OTC MONOGRAPH NOT FINAL part334 Advance Pharmaceutical Inc. SENNOSIDES A AND B 8.6 mg/1 N 20181231 17714-124_5cc973b8-e563-2f6c-e053-2a91aa0a9ab8 17714-124 HUMAN OTC DRUG SENNA-S Senna and Docusate Sodium Tablets, 8.6 mg and 50 mg TABLET ORAL 20170201 OTC MONOGRAPH NOT FINAL part334 Advance Pharmaceutical Inc. SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 17714-133_60f41580-e074-faad-e053-2a91aa0a9076 17714-133 HUMAN OTC DRUG ACETAMINOPHEN PM ACETAMINOPHEN PM TABLET ORAL 20020109 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 17714-135_60f4322f-5c99-096a-e053-2a91aa0a64eb 17714-135 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride TABLET ORAL 20060926 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 17714-150_5cc973b8-e550-2f6c-e053-2a91aa0a9ab8 17714-150 HUMAN OTC DRUG Mucus Relief Cough and Congestion DM Guaifenesin and Dextromethorphan HBr TABLET ORAL 20170801 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 17714-152_5cc992c7-a1b3-46be-e053-2991aa0a1f8f 17714-152 HUMAN OTC DRUG Mucus Relief Guaifenesin 400 mg TABLET ORAL 20161101 OTC MONOGRAPH FINAL part341 Advance Pharmaceutical Inc. GUAIFENESIN 400 mg/1 N 20181231 17772-101_da26a6be-19b9-41af-b6eb-bd0aca9e287a 17772-101 HUMAN PRESCRIPTION DRUG Trokendi XR topiramate CAPSULE, EXTENDED RELEASE ORAL 20130816 NDA NDA201635 Supernus Pharmaceuticals TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 17772-102_da26a6be-19b9-41af-b6eb-bd0aca9e287a 17772-102 HUMAN PRESCRIPTION DRUG Trokendi XR topiramate CAPSULE, EXTENDED RELEASE ORAL 20130816 NDA NDA201635 Supernus Pharmaceuticals TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 17772-103_da26a6be-19b9-41af-b6eb-bd0aca9e287a 17772-103 HUMAN PRESCRIPTION DRUG Trokendi XR topiramate CAPSULE, EXTENDED RELEASE ORAL 20130816 NDA NDA201635 Supernus Pharmaceuticals TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 17772-104_da26a6be-19b9-41af-b6eb-bd0aca9e287a 17772-104 HUMAN PRESCRIPTION DRUG Trokendi XR topiramate CAPSULE, EXTENDED RELEASE ORAL 20130816 NDA NDA201635 Supernus Pharmaceuticals TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 17772-121_46d7dae0-c6f1-42a1-9607-096368c2bb0f 17772-121 HUMAN PRESCRIPTION DRUG OXTELLAR XR OXCARBAZEPINE TABLET ORAL 20130117 NDA NDA202810 Supernus OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 17772-122_46d7dae0-c6f1-42a1-9607-096368c2bb0f 17772-122 HUMAN PRESCRIPTION DRUG OXTELLAR XR OXCARBAZEPINE TABLET ORAL 20130117 NDA NDA202810 Supernus OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 17772-123_46d7dae0-c6f1-42a1-9607-096368c2bb0f 17772-123 HUMAN PRESCRIPTION DRUG OXTELLAR XR OXCARBAZEPINE TABLET ORAL 20130117 NDA NDA202810 Supernus OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 17819-1066_f7e0a5f7-1b57-4a04-973f-fb4dd2d2ffd9 17819-1066 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19870101 NDA NDA205766 Noble Gas Solutions, Inc. NITROGEN 99 L/100L N 20191231 17819-1072_801f057f-df9d-4d8f-aefb-6f1fba7dbbee 17819-1072 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19870101 NDA NDA205767 Noble Gas Solutions, Inc. OXYGEN 99 L/100L N 20191231 17856-0007_e72be307-9cf4-4f42-8a2a-ae84e625b60e 17856-0007 HUMAN PRESCRIPTION DRUG SULFATRIM Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19830701 NDA NDA018615 Atlantic Biologicals Corps SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 17856-0008_ce62f292-478c-46bc-9538-a3d7465263e4 17856-0008 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20120703 NDA NDA021282 Atlantic Biologicals Corps GUAIFENESIN 600 mg/1 N 20181231 17856-0010_cabe563d-b335-4224-a4e7-8a0c4f877790 17856-0010 HUMAN PRESCRIPTION DRUG Dialyvite Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid TABLET, COATED ORAL 19880801 UNAPPROVED DRUG OTHER Atlantic Biologicals Corps ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; COBALAMIN; BIOTIN; CALCIUM PANTOTHENATE 100; 1.5; 1.7; 20; 10; 1; 6; 300; 10 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 17856-0021_42719fda-d898-4749-b561-f85a5e54cd06 17856-0021 HUMAN PRESCRIPTION DRUG Renagel Renagel TABLET ORAL 20080606 NDA NDA021179 Atlantic Biologicals Corps SEVELAMER HYDROCHLORIDE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 17856-0034_ed627ef8-e335-45e2-b965-b4970f826849 17856-0034 HUMAN PRESCRIPTION DRUG Omega-3-Acid Ethyl Esters Omega-3-Acid Ethyl Esters CAPSULE, LIQUID FILLED ORAL 20151130 ANDA ANDA204940 Atlantic Biologicals Corps OMEGA-3-ACID ETHYL ESTERS 1 g/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 17856-0036_6a72a6a0-8516-499c-bdd3-cdd53e5b246e 17856-0036 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate POWDER ORAL; RECTAL 20120725 ANDA ANDA040905 Atlantic Biologicals Corps SODIUM POLYSTYRENE SULFONATE 1 g/g N 20181231 17856-0037_57320d11-f384-428c-9b3e-e58adc8d919f 17856-0037 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 19950415 ANDA ANDA062512 ATLANTIC BIOLOGICALS CORP. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 17856-0043_19078c90-5ea1-4bcf-bc45-48a98be6f698 17856-0043 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP ORAL 20080208 ANDA ANDA040613 Atlantic Biologicals Corps HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 17856-0056_afef38db-36dc-44c5-a4bd-0adc456aefc8 17856-0056 HUMAN OTC DRUG Mucinex DM Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20120626 NDA NDA021620 ATLANTIC BIOLOGICALS CORP GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 600; 30 mg/1; mg/1 N 20181231 17856-0057_7a0fee6f-de5d-4bf9-8a32-9e61e79d084c 17856-0057 HUMAN PRESCRIPTION DRUG Digoxin Digoxin SOLUTION ORAL 20040826 NDA NDA021648 Atlantic Biologicals Corps DIGOXIN .05 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 17856-0067_82c40b58-dc51-435a-9447-e3041bc921b2 17856-0067 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20020624 ANDA ANDA040420 Atlantic Biologicals Corps PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 17856-0079_028e68f7-7c9f-4704-8269-62bc57a314f7 17856-0079 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 19960426 ANDA ANDA040119 Atlantic Biologicals Corps ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 17856-0082_8057484a-320f-4824-8c2e-977929bce8e4 17856-0082 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir SUSPENSION ORAL 20050607 ANDA ANDA077026 Atlantic Biologicals Corps ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 17856-0084_99a1ceca-cb48-4386-8a0c-6e53c62b4a30 17856-0084 HUMAN PRESCRIPTION DRUG LOVAZA omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20160519 NDA NDA021654 Atlantic Biologicals Corps OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 17856-0088_f41a71be-60fe-4c50-baa0-f8986c6ee99b 17856-0088 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20080226 ANDA ANDA077728 Atlantic Biologicals Corps CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 17856-0090_bc14ff58-4ce4-40f9-ae0e-0d6c6d269661 17856-0090 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20100528 ANDA ANDA090121 Atlantic Biologicals Corps FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 17856-0091_ec413818-72dc-47fe-b41b-1d294620c697 17856-0091 HUMAN OTC DRUG Aluminum Hydroxide aluminum hydroxide LIQUID ORAL 20050201 OTC MONOGRAPH FINAL part331 Atlantic Biologicals Corps ALUMINUM HYDROXIDE 320 mg/5mL N 20181231 17856-0092_3af3e7d0-d309-40e8-98dc-4a133cec5782 17856-0092 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride SYRUP ORAL 19970212 ANDA ANDA074868 Atlantic Biologicals Corps OXYBUTYNIN CHLORIDE 5 mg/5mL Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 17856-0093_37af4053-45d3-4e8b-9c6c-165c1eec10cf 17856-0093 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride AMANTADINE HYDROCHLORIDE SOLUTION ORAL 19981224 ANDA ANDA075060 Atlantic Biologicals Corps AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 17856-0108_a5f6f300-167e-d40a-1071-f035c247c651 17856-0108 HUMAN PRESCRIPTION DRUG RAMIPRIL RAMIPRIL CAPSULE ORAL 20080618 ANDA ANDA077900 Atlantic Biologicals Corps RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 17856-0112_bdfe407c-dd0b-4153-b44c-f18410267fe5 17856-0112 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20091030 ANDA ANDA065123 Atlantic Biologicals Corps MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 17856-0116_1a663219-308a-4d3a-acfa-bb5ef9dc3fff 17856-0116 HUMAN OTC DRUG Silace Docusate sodium LIQUID ORAL 19901005 OTC MONOGRAPH NOT FINAL part334 ATLANTIC BIOLOGICALS CORP. DOCUSATE SODIUM 10 mg/mL N 20181231 17856-0117_d38d0ed7-dc75-4854-b9dd-250209aa12a9 17856-0117 HUMAN OTC DRUG Siltussin SA Guaifenesin LIQUID ORAL 19981005 OTC MONOGRAPH FINAL part341 Atlantic Biologicals Corps GUAIFENESIN 100 mg/5mL N 20181231 17856-0130_73ae51f5-e9bf-4bb3-af90-3434932f46ef 17856-0130 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20090812 NDA NDA022127 Atlantic Biologicals Corps SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 17856-0135_29a73355-ea37-4472-880e-e6f965356f0b 17856-0135 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20160411 ANDA ANDA205101 Atlantic Biologicals Corps GABAPENTIN 800 mg/800mg Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 17856-0145_393e4344-81b1-42b1-9ade-a9abee8975f7 17856-0145 HUMAN OTC DRUG Infants Silapap Acetaminophen SOLUTION/ DROPS ORAL 19970401 OTC MONOGRAPH NOT FINAL part343 Atlantic Biologicals Corps ACETAMINOPHEN 80 mg/.8mL N 20181231 17856-0150_58d4b495-ae78-46bb-acac-341fe816c8fe 17856-0150 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride SYRUP ORAL 19950309 ANDA ANDA087294 Atlantic Biologicals Corps HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 17856-0170_6421a01f-5680-447b-9e8b-482c62671c47 17856-0170 HUMAN PRESCRIPTION DRUG Carafate Sucralfate SUSPENSION ORAL 19931216 NDA NDA019183 Atlantic Biologicals Corps SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 17856-0194_9cd0086c-fa5c-48b5-a58f-afa04e737070 17856-0194 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Atlantic Biologicals Corps NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 17856-0205_8fe8cdc9-104d-4dc7-a2ad-49f6e5894843 17856-0205 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL 20020705 ANDA ANDA076058 Atlantic Biologicals Corps MIDAZOLAM HYDROCHLORIDE 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 17856-0210_8508e19e-ce82-45b6-ba00-a546de72c205 17856-0210 HUMAN PRESCRIPTION DRUG PAROEX Chlorhexidine Gluconate RINSE ORAL 20141031 ANDA ANDA076434 ATLANTIC BIOLOGICALS CORP. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 17856-0211_65059521-b17f-4669-a296-9659e684215b 17856-0211 HUMAN OTC DRUG Good Neighbor Pharmacy childrens pain and fever Acetaminophen SUSPENSION ORAL 20170310 OTC MONOGRAPH NOT FINAL part343 ATLANTIC BIOLOGICALS CORP. ACETAMINOPHEN 160 mg/5mL N 20181231 17856-0235_f75c6ba1-6695-4bcb-88ec-63efd2acdf92 17856-0235 HUMAN PRESCRIPTION DRUG Hydrocodone Polistirex and Chlorpheniramine Polisitrex Hydrocodone Polistirex and Chlorpheniramine Polisitrex SUSPENSION, EXTENDED RELEASE ORAL 20120816 ANDA ANDA091632 Atlantic Biologicals Corps HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE 10; 8 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII N 20181231 17856-0237_b92d2542-a417-422b-9c1d-3da132351ab9 17856-0237 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20080317 NDA NDA022195 Atlantic Biologicals Corps MORPHINE SULFATE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 17856-0238_92017df7-a9dd-4135-907c-777f1287b24f 17856-0238 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20080317 NDA NDA022195 Atlantic Biologicals Corps MORPHINE SULFATE 20 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 17856-0241_40d604b5-14f2-4af4-ab6b-5afbc46d48ed 17856-0241 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam SOLUTION ORAL 20120228 ANDA ANDA090601 Atlantic Biologicals Corps. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 17856-0263_a9985fdf-5b93-4a42-80b5-ad952c24db64 17856-0263 HUMAN OTC DRUG Stool Softener Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH NOT FINAL part334 Atlantic Biologicals Corps DOCUSATE SODIUM 250 mg/1 N 20181231 17856-0276_bdd04e98-34da-44e9-b6e6-5e7eb3d23294 17856-0276 HUMAN OTC DRUG Delsym (Dextromethorphan) Dextromethorphan SUSPENSION, EXTENDED RELEASE ORAL 20110819 NDA NDA018658 Atlantic Biologicals Corps DEXTROMETHORPHAN 30 mg/5mL N 20181231 17856-0301_d6f4aadf-6381-439e-99a3-ac9fdde39a0c 17856-0301 HUMAN PRESCRIPTION DRUG Hydrocodone Polistirex and Chlorpheniramine Polistirex Hydrocodone Polistirex and Chlorpheniramine Polistirex SUSPENSION, EXTENDED RELEASE ORAL 20141023 ANDA ANDA091671 Atlantic Biologicals Corps HYDROCODONE; CHLORPHENIRAMINE 10; 8 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII N 20181231 17856-0311_a85eb3d4-e7d4-4a52-87fd-5d57e2732175 17856-0311 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin SOLUTION ORAL 20110223 ANDA ANDA078974 Atlantic Biologicals Corps GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 17856-0312_c65380f0-bb93-4db9-8166-cde6c5ef97df 17856-0312 HUMAN OTC DRUG GAVILAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091009 ANDA ANDA091077 Atlantic Biologicals Corps POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 17856-0377_c9bef39c-337b-4e5c-b225-43fb689eb50e 17856-0377 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20140203 ANDA ANDA203135 Atlantic Biologicals Corps CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 17856-0380_09287282-1b8e-4c4d-a32f-193630499b8e 17856-0380 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20110531 ANDA ANDA091384 Atlantic Biologicals Corps RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 17856-0393_f2bbcfcb-b0de-413e-aca1-cc786d10b7c1 17856-0393 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20150101 ANDA ANDA203208 Atlantic Biologicals Corps OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 17856-0423_349db5fb-2b6b-4fb8-8beb-7f045c1706ed 17856-0423 HUMAN PRESCRIPTION DRUG Donnatal phenobarbital elixir ELIXIR ORAL 20091101 UNAPPROVED DRUG OTHER Atlantic Biologicals Corps PHENOBARBITAL; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; ATROPINE SULFATE 16.2; .1037; .0065; .0194 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 17856-0443_66f70512-0231-48f7-b4ee-296aa63bd397 17856-0443 HUMAN OTC DRUG STOOL SOFTENER EXTRA STRENGTH DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Atlantic Biologicals Corps DOCUSATE SODIUM 250 mg/1 N 20181231 17856-0450_d6b9770a-ae60-43d7-a611-ab627652d970 17856-0450 HUMAN PRESCRIPTION DRUG Lortab Hydrocodone Bitartrate and Acetaminophen SYRUP ORAL 20150317 ANDA ANDA040881 Atlantic Biologicals Corps HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 17856-0452_95a931aa-0cc9-4304-ad2a-914a270e5ecf 17856-0452 HUMAN OTC DRUG Senna Syrup sennosides LIQUID ORAL 20171201 OTC MONOGRAPH NOT FINAL part334 Atlantic Biologicals Corps SENNOSIDES 8.8 mg/5mL N 20181231 17856-0496_bc565fd4-2574-47d1-9b87-0d179cf34c55 17856-0496 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20171004 ANDA ANDA091348 ATLANTIC BIOLOGICALS CORP. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 17856-0500_d0b4b624-4f53-44ce-b722-63774b4908ca 17856-0500 HUMAN OTC DRUG Codeine-Guaifenesin Codeine Phosphate and Guaifenesin SOLUTION ORAL 20140401 OTC MONOGRAPH FINAL part341 ATLANTIC BIOLOGICALS CORP. CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV N 20181231 17856-0511_ea026c29-7873-4b24-a34f-73bd985d6b49 17856-0511 HUMAN PRESCRIPTION DRUG Hyosyne Hyoscyamine Sulfate ELIXIR ORAL 19971101 UNAPPROVED DRUG OTHER Atlantic Biologicals Corps HYOSCYAMINE SULFATE .125 mg/5mL N 20181231 17856-0514_f9ac6bd5-0f1e-4217-b848-75338f8f8f9f 17856-0514 HUMAN PRESCRIPTION DRUG Hyosyne Hyoscyamine Sulfate ELIXIR ORAL 19971101 UNAPPROVED DRUG OTHER ATLANTIC BIOLOGICALS CORP. HYOSCYAMINE SULFATE .125 mg/5mL N 20181231 17856-0527_197fb88c-2353-4941-984f-fb9384b4b974 17856-0527 HUMAN PRESCRIPTION DRUG METHADOSE methadone hydrochloride CONCENTRATE ORAL 20100310 NDA NDA017116 Atlantic Biologicals Corps METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 17856-0537_4a554ceb-98b8-4c9c-96d6-8b40ec4b4492 17856-0537 HUMAN PRESCRIPTION DRUG Metoclopramide metoclopramide hydrochloride SOLUTION ORAL 19910601 ANDA ANDA072744 Atlantic Biologicals Corps METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 17856-0538_90cce358-aa37-4e60-bba8-1f04aecc647c 17856-0538 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 19950415 ANDA ANDA062512 ATLANTIC BIOLOGICALS CORP. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 17856-0540_1b2649f2-df2e-4fed-a25a-7df9093103db 17856-0540 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide SOLUTION ORAL 20060614 ANDA ANDA077629 Atlantic Biologicals Corps CITALOPRAM HYDROBROMIDE 10 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 17856-0576_9fb7d0f5-15f6-486a-8bac-07a6709172bd 17856-0576 HUMAN PRESCRIPTION DRUG Metoclopramide metoclopramide hydrochloride SOLUTION ORAL 19910601 ANDA ANDA072744 Atlantic Biologicals Corps METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 17856-0581_4e108b29-cccc-4c0f-baa3-9943c65fc801 17856-0581 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol SOLUTION, CONCENTRATE ORAL 20091110 ANDA ANDA073037 Atlantic Biologicals Corps HALOPERIDOL 2 mg/mL Typical Antipsychotic [EPC] N 20181231 17856-0595_159cd997-90a9-484a-8018-f4f63889b190 17856-0595 HUMAN PRESCRIPTION DRUG Sodium Citrate and Citric Acid SODIUM CITRATE and CITRIC ACID MONOHYDRATE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Atlantic Biologicals Corps SODIUM CITRATE; ANHYDROUS CITRIC ACID 500; 334 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 17856-0604_f9917f94-1268-42fb-ba0e-75e11c19ba8a 17856-0604 HUMAN PRESCRIPTION DRUG Dextromethorphan Hydrobromide and Promethazine Hydrochloride Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 19850104 ANDA ANDA088864 Atlantic Biologicals Corps DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 17856-0608_0e49ffbd-9e5a-469b-ba93-379548af10b9 17856-0608 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 19821115 ANDA ANDA087953 Atlantic Biologicals Corps PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 17856-0618_8f9655ba-3bea-4a51-9a5d-4dcd3c34f185 17856-0618 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SOLUTION ORAL 19951117 ANDA ANDA074352 Atlantic Biologicals Corps LOPERAMIDE HYDROCHLORIDE 1 mg/5mL N 20181231 17856-0640_1ac3e745-9f9b-0f7d-e054-00144ff8d46c 17856-0640 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate, Acetaminophen SOLUTION ORAL 20110727 ANDA ANDA040894 Atlantic Biologicals Corps ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 17856-0644_a2be0daf-8d5e-469f-a61b-cfcee7a19c16 17856-0644 HUMAN PRESCRIPTION DRUG ELIXOPHYLLIN THEOPHYLLINE ANHYDROUS LIQUID ORAL 20091001 ANDA ANDA085186 Atlantic Biologicals Corps THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 17856-0664_9d0f743b-84a7-4258-93d6-4ab6b573e400 17856-0664 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SOLUTION ORAL 20100312 ANDA ANDA078312 Atlantic Biologicals Corps RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 17856-0668_53134984-468f-4913-982c-30f895aa6154 17856-0668 HUMAN PRESCRIPTION DRUG PRENATAL PLUS VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE TABLET, FILM COATED ORAL 20091202 UNAPPROVED DRUG OTHER Atlantic Biologicals Corps VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE 3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 17856-0673_11c32f49-4cb0-4ea0-8f96-49c48031ecb4 17856-0673 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20110531 ANDA ANDA091384 Atlantic Biologicals Corps RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 17856-0680_31f47d70-6802-4673-ba13-272903b729f8 17856-0680 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Atlantic Biologicals Corps ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 17856-0685_1b851ea3-1cfb-4477-b72d-e878a3519e16 17856-0685 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20091027 ANDA ANDA090992 Atlantic Biologicals Corps LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 17856-0691_9ed47645-497e-4980-a0b1-6f6276281262 17856-0691 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron SOLUTION ORAL 20101217 ANDA ANDA091483 Atlantic Biologicals Corps ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 17856-0711_e97a0573-7a2a-49b4-a29a-f51f34fc3140 17856-0711 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine TABLET ORAL 19981125 ANDA ANDA075109 Atlantic Biologicals Corps GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 17856-0723_bfc3d12f-6241-407f-b2f1-98290a6cac68 17856-0723 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol 0.25 mcg CAPSULE ORAL 20141212 ANDA ANDA091356 Atlantic Biologicals Corps CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 17856-0727_4ca3b7ed-3b83-4209-916d-99a17dfaab3e 17856-0727 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SOLUTION ORAL 20090919 ANDA ANDA077405 ATLANTIC BIOLOGICALS CORP. RANITIDINE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 17856-0732_8490881d-49e1-48bb-b343-91f373212fdf 17856-0732 HUMAN OTC DRUG Cepacol Extra Strength Sore Throat honey lemon Benzocaine and Menthol LOZENGE ORAL 20130715 OTC MONOGRAPH NOT FINAL part356 Atlantic Biologicals Corps BENZOCAINE; MENTHOL 15; 2.6 mg/1; mg/1 N 20181231 17856-0740_dca8649e-e24a-4944-866d-bcaed7385410 17856-0740 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 19980130 ANDA ANDA074749 Atlantic Biologicals Corps ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 17856-0759_d8500e4d-07fc-4c29-a3f0-f333eeddb846 17856-0759 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20050425 ANDA ANDA076913 Atlantic Biologicals Corps. PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 17856-0775_e12a9816-b5ad-410b-a18c-5ebad0387915 17856-0775 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 Atlantic Biologicals Corps LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 17856-0783_7cc7dd8e-0094-446c-8d32-d3c706b92c78 17856-0783 HUMAN PRESCRIPTION DRUG LOVAZA omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20081021 NDA NDA021654 Atlantic Biologicals Corps OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 17856-0788_88f9cba9-e8a2-4ea7-89ce-dbb906b7d175 17856-0788 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20101208 OTC MONOGRAPH FINAL part334 Atlantic Biologicals Corps MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 17856-0792_ecfe5102-f404-416a-a0c1-a798f9446642 17856-0792 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 19950113 ANDA ANDA074060 Atlantic Biologicals Corps VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 17856-0804_bac94880-a702-43e3-ba7e-0c62928a0c31 17856-0804 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Codeine Phosphate Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 19970826 ANDA ANDA040151 Atlantic Biologicals Corps PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 17856-0823_de628bd1-ab7f-48fa-890a-6ced44979f01 17856-0823 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19971229 ANDA ANDA074650 Atlantic Biologicals Corps SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 17856-0843_2add1cff-3996-413a-ba42-2ad59280f684 17856-0843 HUMAN OTC DRUG Childrens QPAP acetaminophen SUSPENSION ORAL 20000901 20180531 OTC MONOGRAPH NOT FINAL part343 Atlantic Biologicals Corps ACETAMINOPHEN 160 mg/5mL N 20181231 17856-0865_867f210f-d85c-4e78-b8a0-cf5d05416227 17856-0865 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090116 ANDA ANDA079120 Atlantic Biologicals Corps LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 17856-0901_7c874aab-40af-4eb4-9369-dfb742a69ede 17856-0901 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH NOT FINAL part343 Atlantic Biologicals Corps ASPIRIN 325 mg/1 N 20181231 17856-0907_23be6d9b-9f77-413c-aa1a-9e295b5844ca 17856-0907 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20010725 ANDA ANDA075671 Atlantic Biologicals Corps MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 17856-0949_bcb4eb8f-40da-47b5-9061-dbc973467acb 17856-0949 HUMAN PRESCRIPTION DRUG Megace ES megesterol acetate SUSPENSION ORAL 20050702 NDA NDA021778 Atlantic Biologicals Corps MEGESTROL ACETATE 125 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 17856-0985_a5473d40-f98d-4b6c-8b8d-395d4239bffc 17856-0985 HUMAN OTC DRUG Childrens MAPAP Acetaminophen Acetaminophen LIQUID ORAL 20120820 OTC MONOGRAPH NOT FINAL part343 Atlantic Biologicals Corps ACETAMINOPHEN 160 mg/5mL N 20181231 17856-1000_a58b0cb1-90ab-42bd-951c-5c7cbaa01554 17856-1000 HUMAN OTC DRUG Senexon Sennosides A and B SYRUP ORAL 20130215 OTC MONOGRAPH NOT FINAL part334 Atlantic Biologicals Corps SENNOSIDES A AND B 8.8 mg/5mL N 20181231 17856-1024_c033a166-a47c-4971-a9e5-34d8431fd3b0 17856-1024 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20101020 ANDA ANDA074584 Atlantic Biologicals Corps BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 17856-1061_2fd64c85-4b05-4479-ac8a-883c39074539 17856-1061 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20130227 NDA AUTHORIZED GENERIC NDA012462 Atlantic Biologicals Corps DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 17856-1107_6efa2553-21f7-4bad-b36a-f88e1fa59030 17856-1107 HUMAN OTC DRUG SENNA SENNOSIDES A AND B LIQUID ORAL 20120619 OTC MONOGRAPH NOT FINAL part334 ATLANTIC BIOLOGICALS CORP. SENNOSIDES A AND B 415.36 mg/236mL N 20181231 17856-1136_e0f8864e-3fb9-4489-be6f-935e45d5d1e0 17856-1136 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate POWDER ORAL; RECTAL 20120725 ANDA ANDA040905 ATLANTIC BIOLOGICALS CORP SODIUM POLYSTYRENE SULFONATE 1 g/g N 20181231 17856-1150_52093730-4ab4-424c-b57d-b1708efe36ff 17856-1150 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140207 ANDA ANDA065264 Atlantic Biologicals Corps CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 17856-1161_09e3911c-ccf4-4ba2-a753-5779ec47854c 17856-1161 HUMAN PRESCRIPTION DRUG dicyclomine hydrochloride dicyclomine hydrochloride SOLUTION ORAL 20050623 ANDA ANDA040169 Atlantic Biologicals Corps DICYCLOMINE HYDROCHLORIDE 10 mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 17856-1206_c409a22d-9e77-4cf5-b8db-3d2f0d544fa1 17856-1206 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20100813 NDA NDA020725 Atlantic Biologicals Corps PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 6000; 19000; 30000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 17856-1212_a5708817-22eb-45e9-a444-2b28f709201b 17856-1212 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20100813 NDA NDA020725 Atlantic Biologicals Corps PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 12000; 38000; 60000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 17856-1224_c2989de9-dfa7-4470-8d03-cc40b849b3cc 17856-1224 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20100813 NDA NDA020725 Atlantic Biologicals Corps PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 24000; 76000; 120000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 17856-1311_0c5233fb-d333-4fa5-b082-934cb25a6743 17856-1311 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin SOLUTION ORAL 20110223 ANDA ANDA078974 Atlantic Biologicals Corps GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 17856-1313_97277c5f-34bd-4e1b-adee-422d78bb6f03 17856-1313 HUMAN OTC DRUG Bismatrol Bismuth Subsalicylate LIQUID ORAL 20080530 OTC MONOGRAPH FINAL part335 Atlantic Biologicals Corps BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 17856-1378_dda97636-92e3-4623-9bb9-f21599da143d 17856-1378 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20010726 ANDA ANDA075993 Atlantic Biologicals Corps LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 17856-1491_4313b89a-66f8-4d1c-abfe-4e52a7bd1a0b 17856-1491 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride SOLUTION ORAL 20041228 ANDA ANDA076682 Atlantic Biologicals Corps OXYBUTYNIN CHLORIDE 5 mg/5mL Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 17856-1508_0bdcd8b2-ccbb-4148-ba72-d066dbf8f4ca 17856-1508 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital ELIXIR ORAL 19970101 UNAPPROVED DRUG OTHER Atlantic Biologicals Corps PHENOBARBITAL 20 mg/5mL CIV N 20181231 17856-1542_af8cee12-4f7d-412a-bed7-c0274637da29 17856-1542 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride SOLUTION ORAL 20150504 NDA NDA206814 Atlantic Biologicals Corps POTASSIUM CHLORIDE 20 meq/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 17856-1543_a588e0c8-3f79-49f3-a855-dea9318ca697 17856-1543 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride SOLUTION ORAL 20170201 NDA NDA206814 ATLANTIC BIOLOGICALS CORP. POTASSIUM CHLORIDE 20 meq/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 17856-1585_482db043-19a2-486d-9dee-63a1fe4d49fc 17856-1585 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20060131 ANDA ANDA040650 Atlantic Biologicals Corps PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV N 20181231 17856-1787_611b1ca5-83cf-4796-a476-1654d44c04e7 17856-1787 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 Atlantic Biologicals Corps BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 17856-1823_c49d9190-7a83-42a3-a295-b654a8d492f1 17856-1823 HUMAN OTC DRUG Qdryl Allergy Diphenhydramine Hydrochloride SOLUTION ORAL 19971201 OTC MONOGRAPH FINAL part341 ATLANTIC BIOLOGICALS CORP DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 17856-1984_84c6345c-0f3b-4bf5-aa86-7fd8f92b198b 17856-1984 HUMAN OTC DRUG Childrens MAPAP Acetaminophen Acetaminophen LIQUID ORAL 20120820 OTC MONOGRAPH NOT FINAL part343 Atlantic Biologicals Corps ACETAMINOPHEN 160 mg/5mL N 20181231 17856-1985_9b9b8dd0-a96e-42cb-be4d-4632c1cb1893 17856-1985 HUMAN OTC DRUG Childrens MAPAP Acetaminophen Acetaminophen LIQUID ORAL 20160722 OTC MONOGRAPH NOT FINAL part343 Atlantic Biologicals Corps ACETAMINOPHEN 160 mg/5mL N 20181231 17856-1986_118037f0-7325-4bba-8116-5128b3247d14 17856-1986 HUMAN OTC DRUG Childrens MAPAP Acetaminophen Acetaminophen LIQUID ORAL 20120820 OTC MONOGRAPH NOT FINAL part343 Atlantic Biologicals Corps ACETAMINOPHEN 160 mg/5mL N 20181231 17856-2001_26e19b31-6f78-44b0-95ab-d6346a3b77fe 17856-2001 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090801 ANDA ANDA077789 Atlantic Biologicals Corps. CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 17856-3117_50b4b62b-e66d-4b08-b687-8e1667e2608b 17856-3117 HUMAN OTC DRUG Calcium Carbonate Calcium Carbonate SUSPENSION ORAL 20041201 OTC MONOGRAPH FINAL part331 Atlantic Biologicals Corps CALCIUM CARBONATE 1250 mg/5mL N 20181231 17856-3188_42034081-428c-1b3d-5062-ed0c8f970609 17856-3188 HUMAN PRESCRIPTION DRUG Diazepam Diazepam SOLUTION ORAL 19870403 ANDA ANDA070928 Atlantic Biologicals Corps DIAZEPAM 5 mg/5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 17856-3194_3362fdb8-3317-4bec-b42b-db6b54b2768a 17856-3194 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate SOLUTION ORAL 19820503 ANDA ANDA087708 Atlantic Biologicals Corps DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/5mL; mg/5mL Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 17856-3298_19cdde0c-a4f5-47a1-bda1-f4cf9eca53b0 17856-3298 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 19870422 ANDA ANDA070433 Atlantic Biologicals Corps FUROSEMIDE 40 mg/5mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 17856-3555_bb65d8d4-bf3b-4072-8857-b7332578da14 17856-3555 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride SOLUTION ORAL 19810522 ANDA ANDA087393 Atlantic Biologicals Corps METHADONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 17856-3556_bb65d8d4-bf3b-4072-8857-b7332578da14 17856-3556 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride SOLUTION ORAL 19820830 ANDA ANDA087997 Atlantic Biologicals Corps METHADONE HYDROCHLORIDE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 17856-3566_a38755d7-9e22-4333-a386-64eaae615893 17856-3566 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL 20020430 ANDA ANDA075873 Atlantic Biologicals Corps MIDAZOLAM HYDROCHLORIDE 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 17856-3700_32e3b0cb-965a-40f0-b0ce-931b61805e75 17856-3700 HUMAN OTC DRUG Stool Softener DC Laxative DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20130904 OTC MONOGRAPH NOT FINAL part334 ATLANTIC BIOLOGICALS CORP. DOCUSATE CALCIUM 240 mg/1 N 20181231 17856-3722_120e4802-4cac-40a2-beae-24dc3fd4ff11 17856-3722 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE SOLUTION ORAL 19861213 ANDA ANDA088703 Atlantic Biologicals Corps PREDNISONE 5 mg/mL N 20181231 17856-3727_46e61d3f-323b-49e3-9c28-a5ddace56457 17856-3727 HUMAN PRESCRIPTION DRUG Metoclopramide metoclopramide hydrochloride SOLUTION ORAL 19910601 ANDA ANDA072744 Atlantic Biologicals Corps METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 17856-3728_73c1a7e9-2f66-4ca2-80b0-903dd50595f2 17856-3728 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride SOLUTION ORAL 19870515 ANDA ANDA070979 Atlantic Biologicals Corps PROPRANOLOL HYDROCHLORIDE 20 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 17856-3755_dbda651c-a981-4e87-a188-6594565504c2 17856-3755 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 19870422 ANDA ANDA070433 Atlantic Biologicals Corps FUROSEMIDE 40 mg/5mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 17856-4047_15ad793a-cd4d-4a77-9e90-17e1a59d3062 17856-4047 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine SUSPENSION ORAL 20040920 ANDA ANDA076729 Atlantic Biologicals Corps CARBAMAZEPINE 100 mg/5mL Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 17856-4069_ed7c1cbc-6b29-4419-9ca6-e4bf17a41313 17856-4069 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20040408 ANDA ANDA040521 Atlantic Biologicals Corps PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 17856-4091_25fc2f67-72d9-4170-ac0c-5519cfed31bc 17856-4091 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron SOLUTION ORAL 20101217 ANDA ANDA091483 Atlantic Biologicals Corps ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 17856-5174_a6a5ad00-4d5f-42e1-8aa3-1fee285bff1f 17856-5174 HUMAN OTC DRUG Banophen diphenhydramine hydrochloride LIQUID ORAL 20120824 OTC MONOGRAPH NOT FINAL part348 Atlantic Biologicals Corps DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 17856-5180_12eab105-e605-4010-8be9-850f593ac064 17856-5180 HUMAN OTC DRUG Tussin Sugar Free Cough Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090107 OTC MONOGRAPH FINAL part341 Atlantic Biologicals Corps DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 17856-5309_2587f64e-02fd-4abf-99c2-62ceb9098226 17856-5309 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 19990207 ANDA ANDA074937 Atlantic Biologicals Corps IBUPROFEN 100 mg/5mL N 20181231 17856-5721_f944afac-f5ca-45a4-8953-155d0d229789 17856-5721 HUMAN OTC DRUG MINTOX aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 Atlantic Biologicals Corps ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 17856-5725_b67051cf-8977-4df0-8078-7c72000e57c6 17856-5725 HUMAN OTC DRUG MINTOX MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 Atlantic Biologicals Corps ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 17856-5734_f3cb5faa-d29f-478b-9fbf-db98a920ed1e 17856-5734 HUMAN OTC DRUG Nicorelief Nicotine Polacrilex GUM, CHEWING ORAL 20050412 ANDA ANDA078326 ATLANTIC BIOLOGICALS CORP. NICOTINE 4 mg/1 N 20181231 17856-5736_d1078c13-4ad1-45ac-b13e-dc83762dfbb5 17856-5736 HUMAN OTC DRUG Nicorelief Nicotine Polacrilex GUM, CHEWING ORAL 20050412 ANDA ANDA078325 Atlantic Biologicals Corps NICOTINE 2 mg/1 N 20181231 17856-5894_54000df5-2c03-4e34-a035-e951da86c55b 17856-5894 HUMAN OTC DRUG Infants Gas Relief Simethicone SUSPENSION/ DROPS ORAL 20160901 OTC MONOGRAPH FINAL part332 ATLANTIC BIOLOGICALS CORP. DIMETHICONE 20 mg/.3mL N 20181231 17856-6234_ccf9ac38-566e-4fe2-86c7-0b62b52153fc 17856-6234 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20110217 ANDA ANDA077421 Atlantic Biologicals Corps LORATADINE 5 mg/5mL N 20181231 17856-6289_ce268050-83e0-40c8-b349-208c066cd71f 17856-6289 HUMAN OTC DRUG Senna Sennosides A and B SYRUP ORAL 20120423 OTC MONOGRAPH NOT FINAL part334 Atlantic Biologicals Corps SENNOSIDES A AND B 8.8 mg/5mL N 20181231 17856-6306_a7dc60f8-6b87-42c8-9163-26db09d1d72c 17856-6306 HUMAN OTC DRUG Robafen DM Cough Sugar Free Clear Guaifenesin and Dextromethorphan Hydrobromide SOLUTION ORAL 20121220 OTC MONOGRAPH FINAL part341 Atlantic Biologicals Corps GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 17856-6312_6ceebc64-a438-40f2-8d36-6bfa8dec17fb 17856-6312 HUMAN OTC DRUG cough dm dextromethorphan polistirex SUSPENSION ORAL 20120906 ANDA ANDA091135 ATLANTIC BIOLOGICALS CORP. DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 18018-501_2014a18e-f000-461c-9b94-70bd887eb7bf 18018-501 HUMAN OTC DRUG INSTANT HAND SANITIZER HAND SANITIZER KIT 20091101 OTC MONOGRAPH NOT FINAL part333 NINGBO CLEANER DAILY USED PRODUCTS CO. LTD. E 20171231 18018-502_c2b5661f-05af-40c1-9635-42e649b20488 18018-502 HUMAN OTC DRUG ECOSAVE LAVENDER ANTIBACTERIAL HAND SOAP TRICLOSAN KIT 20091201 OTC MONOGRAPH NOT FINAL part333 NINGBO CLEANER DAILY USED PRODUCTS E 20171231 18018-503_e5cd87f5-c81e-401c-8f57-d59e7253135a 18018-503 HUMAN OTC DRUG ECOSAVE GRAPEFRUIT AND LEMONGRASS SOAP ANTIBACTERIAL HAND SOAP TRICLOSAN KIT 20091201 OTC MONOGRAPH NOT FINAL part333 NINGBO CLEANER DAILY USED PRODUCTS E 20171231 18018-504_3a378e5f-7de5-451e-985d-d4335803c756 18018-504 HUMAN OTC DRUG ECOSAVE JAPANESE CHERRY BLOSSOM SOAP ANTIBACTERIAL HAND SOAP TRICLOSAN KIT 20091201 OTC MONOGRAPH NOT FINAL part333 NINGBO CLEANER DAILY USED PRODUCTS E 20171231 18027-002_54c3a2d6-5dfc-2d7b-e054-00144ff88e88 18027-002 HUMAN OTC DRUG 50% Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20170715 OTC MONOGRAPH NOT FINAL part333A AMERICAN CONSUMER PRODUCTS LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 18027-003_54c38462-ff82-32aa-e054-00144ff88e88 18027-003 HUMAN OTC DRUG 50% Isopropyl Rubbing Alcohol with Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20170715 OTC MONOGRAPH NOT FINAL part333A AMERICAN CONSUMER PRODUCTS LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 18027-004_54c38462-ff90-32aa-e054-00144ff88e88 18027-004 HUMAN OTC DRUG 70% Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20170715 OTC MONOGRAPH NOT FINAL part333A AMERICAN CONSUMER PRODUCTS LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 18027-005_54c38462-ff9e-32aa-e054-00144ff88e88 18027-005 HUMAN OTC DRUG 70% Isopropyl Rubbing Alcohol with Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20170715 OTC MONOGRAPH NOT FINAL part333A AMERICAN CONSUMER PRODUCTS LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 18027-030_2d02971d-7620-4383-af56-d44e0fe3620d 18027-030 HUMAN OTC DRUG PHARMACYS PRESCRIPTION ISOPROPYL ALCOHOL LIQUID TOPICAL 20141001 OTC MONOGRAPH FINAL part344 AMERICAN CONSUMER PRODUCTS LLC ISOPROPYL ALCOHOL 70 g/100g N 20181231 18027-033_f40214c2-c0d8-4960-9ad0-4a94ee5d46c4 18027-033 HUMAN OTC DRUG PHARMACYS PRESCRIPTION HYDROGEN PEROXIDE LIQUID TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A AMERICAN CONSUMER PRODUCTS LLC HYDROGEN PEROXIDE 3 g/100g N 20181231 18027-050_32838f19-46c8-4ed1-e054-00144ff8d46c 18027-050 HUMAN OTC DRUG Pharmacys Prescription Isopropyl Alcohol LIQUID TOPICAL 20160510 OTC MONOGRAPH FINAL part344 American Consumer Products, LLC ISOPROPYL ALCOHOL 1 mL/1 N 20181231 18027-268_45f95bfe-8b56-417d-9a50-ed1f3404ace2 18027-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20160731 OTC MONOGRAPH NOT FINAL part356 American Consumer Products, LLC HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 18087-0001_1a2000c1-f84a-4a17-acc4-bff9ee9498a2 18087-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060106 UNAPPROVED MEDICAL GAS Anaconda Oxygen Service OXYGEN 99 L/100L E 20171231 18124-001_77d2be8d-b993-4458-97e7-86a4cb3505c8 18124-001 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 20121210 ANDA ANDA090503 Fresenius Kabi Austria GmbH LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 18124-002_9ec3b13f-47bb-48db-8ef6-7d01291b48c0 18124-002 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL; RECTAL 20121210 ANDA ANDA090502 Fresenius Kabi Austria GmbH LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 18124-011_a6826aa3-fabb-4ff1-a7a3-cd4c34e3a330 18124-011 HUMAN PRESCRIPTION DRUG Cleviprex clevidipine EMULSION INTRAVENOUS 20080915 NDA NDA022156 Fresenius Kabi Austria GmbH CLEVIDIPINE .5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 18472-175_65ee60ad-1906-4d96-9fe8-0203e0890d46 18472-175 HUMAN OTC DRUG Blue Ice Fermented Cod Liver Oil Calm Balm Camphor, Menthol, Eucalyptus Oil rub SALVE TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 ABS Corporation CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 1.3; 1.73; .37 g/49.5g; g/49.5g; g/49.5g E 20171231 18482-002_60ce32de-22c4-6a26-e053-2a91aa0a67f9 18482-002 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20050701 NDA NDA206009 Inland Welding Supply dba A-L Compressed Gases NITROUS OXIDE 995 mL/L N 20181231 18482-003_60f1f3c9-a974-92f4-e053-2991aa0abd65 18482-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20050701 NDA NDA206024 Inland Welding Supply dba A-L Compressed Gases NITROGEN 99.1 L/L N 20181231 18482-004_60f21558-f1d5-796f-e053-2a91aa0af924 18482-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20050701 NDA NDA206023 Inland Welding Supply dba A-L Compressed Gases OXYGEN 210 mL/L N 20181231 18482-018_65002c27-437a-4c4f-aa19-3315591df97a 18482-018 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20050701 NDA NDA206023 Inland Welding Supply dba A-L Compressed Gases OXYGEN 995 mL/L N 20181231 18482-128_51a87023-e1db-4204-8046-dbbc67ab01f9 18482-128 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitroux Oxide GAS RESPIRATORY (INHALATION) 20050701 UNAPPROVED MEDICAL GAS Inland Welding Supply dba A-L Compressed Gases NITROUS OXIDE 995 mL/L E 20171231 18657-117_308df247-a446-4284-8a1a-04410cd25e52 18657-117 HUMAN PRESCRIPTION DRUG HYLENEX Recombinant Hyaluronidase (Human Recombinant) INJECTION, SOLUTION SUBCUTANEOUS 20051202 NDA NDA021859 Halozyme, Inc. HYALURONIDASE (HUMAN RECOMBINANT) 150 [USP'U]/mL Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] N 20181231 18860-101_3439b90c-94db-4504-975f-ffbb6a5d788a 18860-101 HUMAN PRESCRIPTION DRUG FazaClo clozapine TABLET, ORALLY DISINTEGRATING ORAL 20070701 NDA NDA021590 Jazz Pharmaceuticals, Inc. CLOZAPINE 12.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 18860-102_3439b90c-94db-4504-975f-ffbb6a5d788a 18860-102 HUMAN PRESCRIPTION DRUG FazaClo clozapine TABLET, ORALLY DISINTEGRATING ORAL 20080601 NDA NDA021590 Jazz Pharmaceuticals, Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 18860-104_3439b90c-94db-4504-975f-ffbb6a5d788a 18860-104 HUMAN PRESCRIPTION DRUG FazaClo clozapine TABLET, ORALLY DISINTEGRATING ORAL 20080601 NDA NDA021590 Jazz Pharmaceuticals, Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 18860-105_3439b90c-94db-4504-975f-ffbb6a5d788a 18860-105 HUMAN PRESCRIPTION DRUG FazaClo clozapine TABLET, ORALLY DISINTEGRATING ORAL 20100709 NDA NDA021590 Jazz Pharmaceuticals, Inc. CLOZAPINE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 18860-106_3439b90c-94db-4504-975f-ffbb6a5d788a 18860-106 HUMAN PRESCRIPTION DRUG FazaClo clozapine TABLET, ORALLY DISINTEGRATING ORAL 20100709 NDA NDA021590 Jazz Pharmaceuticals, Inc. CLOZAPINE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 18860-121_30bba641-86d0-41a1-85a6-312886ea18dc 18860-121 HUMAN PRESCRIPTION DRUG VERSACLOZ Clozapine SUSPENSION ORAL 20130215 NDA NDA203479 Jazz Pharmaceuticals, Inc. CLOZAPINE 50 mg/mL Atypical Antipsychotic [EPC] N 20191231 18860-253_9ed49bc4-cb2c-409f-84b6-24d9c052df9f 18860-253 HUMAN PRESCRIPTION DRUG Gesticare DHA thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, choline bitartrate, doconexent, and icosapent KIT 20081001 UNAPPROVED DRUG OTHER Jazz Pharmaceuticals Commercial Corp. N 20181231 18860-480_f3f8fca9-1981-471d-89f5-6b7fbb8f49d6 18860-480 HUMAN PRESCRIPTION DRUG Elestrin estradiol GEL TRANSDERMAL 20070601 NDA NDA021813 Jazz Pharmaceuticals Commercial Corp. ESTRADIOL .6 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 18860-490_a580f922-75d0-407e-a47f-2ad79b7f6900 18860-490 HUMAN PRESCRIPTION DRUG Elestrin estradiol GEL TRANSDERMAL 20070601 NDA NDA021813 Jazz Pharmaceuticals Commercial Corp. ESTRADIOL .6 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 18860-678_4b9be863-75cb-4a8c-ba76-4a59ce9d509f 18860-678 HUMAN PRESCRIPTION DRUG Gastrocrom cromolyn sodium SOLUTION, CONCENTRATE ORAL 19961101 NDA NDA020479 Jazz Pharmaceuticals Commercial Corp. CROMOLYN SODIUM 20 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] E 20171231 18860-720_32e2149a-d3f7-4b58-9ea8-6bca739e1576 18860-720 HUMAN PRESCRIPTION DRUG Prialt ziconotide INJECTION, SOLUTION INTRATHECAL 20041228 NDA NDA021060 Jazz Pharmaceuticals, Inc. ZICONOTIDE ACETATE 100 ug/mL N-Calcium Channel Receptor Antagonists [MoA],N-type Calcium Channel Antagonist [EPC] N 20181231 18860-722_32e2149a-d3f7-4b58-9ea8-6bca739e1576 18860-722 HUMAN PRESCRIPTION DRUG Prialt ziconotide INJECTION, SOLUTION INTRATHECAL 20041228 NDA NDA021060 Jazz Pharmaceuticals, Inc. ZICONOTIDE ACETATE 100 ug/mL N-Calcium Channel Receptor Antagonists [MoA],N-type Calcium Channel Antagonist [EPC] N 20181231 18860-723_32e2149a-d3f7-4b58-9ea8-6bca739e1576 18860-723 HUMAN PRESCRIPTION DRUG Prialt ziconotide INJECTION, SOLUTION INTRATHECAL 20041228 NDA NDA021060 Jazz Pharmaceuticals, Inc. ZICONOTIDE ACETATE 25 ug/mL N-Calcium Channel Receptor Antagonists [MoA],N-type Calcium Channel Antagonist [EPC] N 20181231 18860-752_fc886453-4cee-481a-98e7-29f46f65c3dd 18860-752 HUMAN PRESCRIPTION DRUG Natelle One doconexent,icosapent, tricalcium phosphate, ferrous fumarate, ascorbic acid, pyridoxine hydrochloride, alpha-tocopherol, and folic acid CAPSULE, GELATIN COATED ORAL 20100611 UNAPPROVED DRUG OTHER Jazz Pharmaceuticals Commercial Corp. DOCONEXENT; ICOSAPENT; TRICALCIUM PHOSPHATE; FERROUS FUMARATE; ASCORBIC ACID; PYRIDOXINE HYDROCHLORIDE; .ALPHA.-TOCOPHEROL; FOLIC ACID 250; .625; 102; 28; 30; 25; 30; 1 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 18860-852_06b963be-0817-469e-ad3a-8096324fbe94 18860-852 HUMAN PRESCRIPTION DRUG Natelle One Natelle One CAPSULE, GELATIN COATED ORAL 20091109 UNAPPROVED DRUG OTHER na Azur Pharma, Inc. DOCONEXENT; ICOSAPENT; TRICALCIUM PHOSPHATE; FERROUS FUMARATE; ASCORBIC ACID; PYRIDOXINE HYDROCHLORIDE; ALPHA-TOCOPHEROL, D-; FOLIC ACID 250; .625; 100; 27; 30; 25; 30; 1 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 19218-0001_5c3ad5e7-edb0-8be4-e053-2a91aa0a9edd 19218-0001 HUMAN PRESCRIPTION DRUG Oxygen Size B Oxygen GAS RESPIRATORY (INHALATION) 19560101 UNAPPROVED MEDICAL GAS Anesthesia Service, Inc. OXYGEN 196 L/196L N 20181231 19218-0002_5c3ad5e7-edb0-8be4-e053-2a91aa0a9edd 19218-0002 HUMAN PRESCRIPTION DRUG Oxygen Size C Oxygen GAS RESPIRATORY (INHALATION) 19560101 UNAPPROVED MEDICAL GAS Anesthesia Service, Inc. OXYGEN 240 L/240L N 20181231 19218-0003_5c3ad5e7-edb0-8be4-e053-2a91aa0a9edd 19218-0003 HUMAN PRESCRIPTION DRUG Oxygen Size D Oxygen GAS RESPIRATORY (INHALATION) 19560101 UNAPPROVED MEDICAL GAS Anesthesia Service, Inc. OXYGEN 396 L/396L N 20181231 19218-0004_5c3ad5e7-edb0-8be4-e053-2a91aa0a9edd 19218-0004 HUMAN PRESCRIPTION DRUG Oxygen Size E Oxygen GAS RESPIRATORY (INHALATION) 19560101 UNAPPROVED MEDICAL GAS Anesthesia Service, Inc. OXYGEN 659 L/659L N 20181231 19218-0005_5c3ad5e7-edb0-8be4-e053-2a91aa0a9edd 19218-0005 HUMAN PRESCRIPTION DRUG Oxygen Size M Oxygen GAS RESPIRATORY (INHALATION) 19560101 UNAPPROVED MEDICAL GAS Anesthesia Service, Inc. OXYGEN 3453 L/3453L N 20181231 19218-0006_5c3ad5e7-edb0-8be4-e053-2a91aa0a9edd 19218-0006 HUMAN PRESCRIPTION DRUG Oxygen Size F Oxygen GAS RESPIRATORY (INHALATION) 19560101 UNAPPROVED MEDICAL GAS Anesthesia Service, Inc. OXYGEN 1567 L/1567L N 20181231 19218-0007_5c3ad5e7-edb0-8be4-e053-2a91aa0a9edd 19218-0007 HUMAN PRESCRIPTION DRUG Oxygen Size H Oxygen GAS RESPIRATORY (INHALATION) 19560101 UNAPPROVED MEDICAL GAS Anesthesia Service, Inc. OXYGEN 6931 L/6931L N 20181231 19218-0008_5c3ad5e7-edb0-8be4-e053-2a91aa0a9edd 19218-0008 HUMAN PRESCRIPTION DRUG Oxygen Size T Oxygen GAS RESPIRATORY (INHALATION) 19560101 UNAPPROVED MEDICAL GAS Anesthesia Service, Inc. OXYGEN 8688 L/8688L N 20181231 19218-0009_5c3ad5e7-edb0-8be4-e053-2a91aa0a9edd 19218-0009 HUMAN PRESCRIPTION DRUG Oxygen Size 400 Oxygen GAS RESPIRATORY (INHALATION) 19560101 UNAPPROVED MEDICAL GAS Anesthesia Service, Inc. OXYGEN 11321 L/11321L N 20181231 19392-100_04f696ca-35d4-45b8-9ff1-105d35448bb7 19392-100 HUMAN OTC DRUG Hand Sanitizer alcohol LIQUID TOPICAL 20120611 OTC MONOGRAPH NOT FINAL part333E Humphreyline ALCOHOL 710 g/1000mL E 20171231 19392-110_1c2db6f5-c0da-4b41-b417-9f421c8e93c9 19392-110 HUMAN OTC DRUG Hand Sanitizer Alcohol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Humphreyline ALCOHOL 620 mL/1000mL E 20171231 19392-120_cd1e5eb1-6117-47e7-bfae-6e956fd79ede 19392-120 HUMAN OTC DRUG Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part333E Humphreyline BENZALKONIUM CHLORIDE 1.3 g/1000g E 20171231 19392-130_04fcd1c8-c68a-2b16-e054-00144ff8d46c 19392-130 HUMAN OTC DRUG Hand Sanitizer alcohol LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E Humphreyline ALCOHOL 630 mL/1000mL N 20181231 19392-210_f0eaffc2-6fb9-4934-8320-76cbcd938ef4 19392-210 HUMAN OTC DRUG Hand Sanitizer Alcohol LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Humphreyline ALCOHOL 620 mL/1000mL E 20171231 19392-300_82e77db3-26a5-4ea6-a71e-64a319a9cebe 19392-300 HUMAN OTC DRUG sunscreen octinoxate, oxybenzone LIPSTICK TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 Humphreyline OCTINOXATE; OXYBENZONE 75; 40 mg/g; mg/g N 20181231 19392-400_34817253-7264-43a8-bcaa-1258a75ba993 19392-400 HUMAN OTC DRUG sunscreen octinoxate, octisalate, octocrylene, oxybenzone LOTION TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 Humphreyline OCTINOXATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE 65; 55; 40; 70 mg/g; mg/g; mg/g; mg/g E 20171231 19392-500_b4b8dc11-a87f-46d2-924c-cb7cbeec608a 19392-500 HUMAN OTC DRUG hand sanitizer benzalkonium chloride LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part333E Humphreyline BENZALKONIUM CHLORIDE 1.3 g/1000g N 20181231 19515-896_984ad2ee-5274-44b6-a286-ad2095425872 19515-896 VACCINE Flulaval Quadrivalent 2017/2018 influenza virus vaccine SUSPENSION INTRAMUSCULAR 20170707 BLA BLA125163 ID Biomedical Corporation of Quebec INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL N 20181231 19515-912_984ad2ee-5274-44b6-a286-ad2095425872 19515-912 VACCINE Flulaval Quadrivalent 2017/2018 influenza virus vaccine SUSPENSION INTRAMUSCULAR 20170707 BLA BLA125163 ID Biomedical Corporation of Quebec INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (UV, FORMALDEHYDE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL N 20181231 20146-4000_9dcf7331-9e1e-45e2-96d4-24999bf99e0b 20146-4000 HUMAN OTC DRUG Breaze Nasal Moisturizing Oxymetazoline hydrochloride SPRAY NASAL 20150101 OTC MONOGRAPH FINAL part341 Samson Pharmaceuticals, Inc. OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 20146-4006_4b0da189-f60f-4cbf-9b35-fe2e3b6e86a4 20146-4006 HUMAN OTC DRUG Breaze Nasal Sinus Colds and Allergies Oxymetazoline hydrochloride SPRAY NASAL 20150101 OTC MONOGRAPH FINAL part341 Samson Pharmaceuticals, Inc. OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 20146-4007_c04f6c72-d2f4-4be1-980d-3f443d32bb2d 20146-4007 HUMAN OTC DRUG LA Bodies Eclipse Sunscreen SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20150101 OTC MONOGRAPH FINAL part352 SAMSON PHARMACEUTICAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 130; 50; 20; 40 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 20146-4008_deb1f6d5-f007-4cff-8a8e-25f44115f5c7 20146-4008 HUMAN OTC DRUG LA Bodies Eclipse Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20150101 OTC MONOGRAPH FINAL part352 SAMSON PHARMACEUTICAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 24; 60 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 20146-4009_744c9ee6-5927-4d0f-94e9-1b0e32979329 20146-4009 HUMAN OTC DRUG LA Bodies Purita Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A SAMSON PHARMACEUTICAL ALCOHOL 620 mg/mL E 20171231 20146-7000_0080215d-8588-4dec-a2b6-8da2b5cb3c05 20146-7000 HUMAN OTC DRUG Pure Eyes Sterile Eyes Naphazoline Hydrochloride and Glycerin SOLUTION/ DROPS OPHTHALMIC 20150101 OTC MONOGRAPH FINAL part349 SAMSON PHARMACEUTICAL NAPHAZOLINE HYDROCHLORIDE; GLYCERIN .1; 2.5 mg/mL; mg/mL N 20181231 20151-056_4228a0cb-dacb-6765-e054-00144ff8d46c 20151-056 HUMAN OTC DRUG Purifying Oxygenating Serum Glycerin, dimethicone CREAM TOPICAL 20150716 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA DIMETHICONE; GLYCERIN .75; 12 mg/mL; mg/mL E 20171231 20151-063_403911b5-bd35-3734-e054-00144ff8d46c 20151-063 HUMAN OTC DRUG Luxury Revitalizing Serum Glycerin, dimethicone CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part347 CASMARA COSMETICS, SA GLYCERIN; DIMETHICONE 15; .13 mg/mL; mg/mL E 20171231 20151-068_403911b5-bd00-3734-e054-00144ff8d46c 20151-068 HUMAN OTC DRUG Renovating Regenerating Serum Glycerin CREAM TOPICAL 20160513 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN .25 mg/mL E 20171231 20151-069_403911b5-bcf3-3734-e054-00144ff8d46c 20151-069 HUMAN OTC DRUG Cleanser Balancing Glycerin, Dimethicone LIQUID TOPICAL 20160606 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA DIMETHICONE; GLYCERIN .76; 5.35 mg/mL; mg/mL E 20171231 20151-070_403911b5-bce6-3734-e054-00144ff8d46c 20151-070 HUMAN OTC DRUG Cleanser Balancing Glycerin, Dimethicone LIQUID TOPICAL 20160606 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA DIMETHICONE; GLYCERIN .76; 5.35 mg/mL; mg/mL E 20171231 20151-071_403911b5-bcd9-3734-e054-00144ff8d46c 20151-071 HUMAN OTC DRUG Cleanser Sensitive Skin Glycerin, Dimethicone LIQUID TOPICAL 20160606 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA DIMETHICONE; GLYCERIN .95; 6.125 mg/mL; mg/mL E 20171231 20151-072_403911b5-bccc-3734-e054-00144ff8d46c 20151-072 HUMAN OTC DRUG Cleanser Sensitive Skin Glycerin, Dimethicone LIQUID TOPICAL 20160606 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA DIMETHICONE; GLYCERIN .95; 6.125 mg/mL; mg/mL E 20171231 20151-073_403911b5-bcbf-3734-e054-00144ff8d46c 20151-073 HUMAN OTC DRUG Cleanser Dermopurifying Oily Skin Dimethicone LIQUID TOPICAL 20160606 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA DIMETHICONE 1.52 mg/mL E 20171231 20151-074_403911b5-bcb2-3734-e054-00144ff8d46c 20151-074 HUMAN OTC DRUG 3 en 1 Cleanser. Deep Cleansing Glycerin LIQUID TOPICAL 20160606 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN 13 mg/mL E 20171231 20151-075_403911b5-bca5-3734-e054-00144ff8d46c 20151-075 HUMAN OTC DRUG 3 en 1 Cleanser. Deep Cleansing Glycerin LIQUID TOPICAL 20160606 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN 13 mg/mL E 20171231 20151-076_403911b5-bc97-3734-e054-00144ff8d46c 20151-076 HUMAN OTC DRUG Natural Peeling TriActive Acne Salicylic Acid LOTION TOPICAL 20160703 OTC MONOGRAPH FINAL part333D Casmara Cosmetics, SA SALICYLIC ACID .5 mg/mL E 20171231 20151-077_403911b5-bc89-3734-e054-00144ff8d46c 20151-077 HUMAN OTC DRUG Natural Peeling TriActive Acne Salicylic Acid LOTION TOPICAL 20160703 OTC MONOGRAPH FINAL part333D Casmara Cosmetics, SA SALICYLIC ACID .5 mg/mL E 20171231 20151-081_4911f361-c835-6f13-e054-00144ff8d46c 20151-081 HUMAN OTC DRUG Luxury Revitalizing Moisturizing Cream Glycerin, Dimethicone CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN; DIMETHICONE 5; 4.2 mg/mL; mg/mL N 20181231 20151-082_49123659-5489-0fb5-e054-00144ff8d46c 20151-082 HUMAN OTC DRUG Luxury Revitalizing Nourishing Cream Glycerin. Dimethicone CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA DIMETHICONE; GLYCERIN 3.36; 10 mg/mL; mg/mL N 20181231 20151-083_491e73ea-6f30-0b29-e054-00144ff88e88 20151-083 HUMAN OTC DRUG Purifying Oxygenating Moisturizing Cream Mineral Oil, Glycerin CREAM TOPICAL 20170223 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN; MINERAL OIL 6.5; 17 mg/mL; mg/mL N 20181231 20151-084_491e73ea-6f41-0b29-e054-00144ff88e88 20151-084 HUMAN OTC DRUG Nourishing Cream Mineral Oil, Glycerin CREAM TOPICAL 20150702 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA MINERAL OIL; GLYCERIN 20; 6.5 mg/mL; mg/mL N 20181231 20151-085_4932579f-4ecd-143a-e054-00144ff88e88 20151-085 HUMAN OTC DRUG Renovating Regenerating Nourishing Cream Glycerin CREAM TOPICAL 20160512 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN 1.98 mg/mL N 20181231 20151-086_4932579f-4ee4-143a-e054-00144ff88e88 20151-086 HUMAN OTC DRUG Renovating Regenerating Moisturizing Cream Glycerin CREAM TOPICAL 20170223 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN 7.8 mg/mL N 20181231 20151-087_4932dde7-fc4c-38d4-e054-00144ff8d46c 20151-087 HUMAN OTC DRUG Vitalizing Energizing Serum Glycerin, dimethicone CREAM TOPICAL 20161203 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA DIMETHICONE; GLYCERIN .4; 3 mg/mL; mg/mL N 20181231 20151-088_4932dde7-fc63-38d4-e054-00144ff8d46c 20151-088 HUMAN OTC DRUG Vitalizing Energizing Nourishing Cream Glycerin CREAM TOPICAL 20170223 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN 5 mg/mL N 20181231 20151-089_49334f91-f98c-41a1-e054-00144ff88e88 20151-089 HUMAN OTC DRUG Vitalizing Energizing Moisturizing Cream Glycerin, dimethicone CREAM TOPICAL 20170223 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN; DIMETHICONE 3; .4 mg/mL; mg/mL N 20181231 20151-090_49636dc6-144a-4db9-e054-00144ff8d46c 20151-090 HUMAN OTC DRUG Hydra lifting Firming Nourishing Cream Glycerin CREAM TOPICAL 20170225 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN 13 mg/mL N 20181231 20151-091_4963c81f-b31e-12ed-e054-00144ff8d46c 20151-091 HUMAN OTC DRUG Hydra Lifting Firming Moisturizing Cream Glycerin CREAM TOPICAL 20170225 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN 11 mg/mL N 20181231 20151-093_4963c81f-b32f-12ed-e054-00144ff8d46c 20151-093 HUMAN OTC DRUG Hydra Lifting Firming Fresh Serum 24H Glycerin CREAM TOPICAL 20170225 OTC MONOGRAPH FINAL part347 CASMARA COSMETICS, SA GLYCERIN 8 mg/mL N 20181231 20151-094_49647514-456f-2d47-e054-00144ff8d46c 20151-094 HUMAN OTC DRUG Hydra Lifting Firming Plus Serum 24H Glycerin CREAM TOPICAL 20170225 OTC MONOGRAPH FINAL part347 CASMARA COSMETICS, SA GLYCERIN 8 mg/mL N 20181231 20151-095_4973905f-dac0-2cc5-e054-00144ff8d46c 20151-095 HUMAN OTC DRUG Shine Control Sebum Regulating Gel Glycerin GEL TOPICAL 20170225 OTC MONOGRAPH FINAL part347 CASMARA COSMETICS, SA GLYCERIN 5 mg/mL N 20181231 20151-096_4973905f-dad4-2cc5-e054-00144ff8d46c 20151-096 HUMAN OTC DRUG Shine Control Matte Effect Cream Glycerin, dimethicone CREAM TOPICAL 20170225 OTC MONOGRAPH FINAL part347 CASMARA COSMETICS, SA GLYCERIN; DIMETHICONE 1.12; .75 mg/mL; mg/mL N 20181231 20151-097_49c88164-0dc3-529a-e054-00144ff8d46c 20151-097 HUMAN OTC DRUG Shine Control Moisturizing Matte Effect Cream Glycerin, dimethicone CREAM TOPICAL 20170306 OTC MONOGRAPH FINAL part347 CASMARA COSMETICS, SA GLYCERIN; DIMETHICONE 6.25; 2.18 mg/mL; mg/mL N 20181231 20151-098_4bfb8d15-7727-2877-e054-00144ff88e88 20151-098 HUMAN OTC DRUG Longevity Recovery Serum Glycerin CREAM TOPICAL 20170329 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN 10 mg/mL N 20181231 20151-099_4bf3a064-6996-3d59-e054-00144ff8d46c 20151-099 HUMAN OTC DRUG Longevity Recovery Nourishing Glycerin CREAM TOPICAL 20170329 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN; DIMETHICONE 6; 3.36 mg/mL; mg/mL N 20181231 20151-100_4be8dbfa-a040-3ce7-e054-00144ff8d46c 20151-100 HUMAN OTC DRUG Longevity Recovery Moisturizing Glycerin, dimethicone CREAM TOPICAL 20170329 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN; DIMETHICONE 5; .55 mg/mL; mg/mL N 20181231 20151-102_4c7d855a-f586-13c8-e054-00144ff88e88 20151-102 HUMAN OTC DRUG Lightening Brightening Moisturizing Serum Glycerin CREAM TOPICAL 20170329 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN 30 mg/mL N 20181231 20151-103_4c7e2299-75b1-42ec-e054-00144ff8d46c 20151-103 HUMAN OTC DRUG Lightening Clarifying Concentrated Serum Dimethicone CREAM TOPICAL 20170329 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA DIMETHICONE .75 mg/mL N 20181231 20151-104_4cd0895b-26f1-2b99-e054-00144ff8d46c 20151-104 HUMAN OTC DRUG Age Defense Pro Prebiotic Technology Econature Glycerin CREAM TOPICAL 20170329 OTC MONOGRAPH FINAL part347 Casmara Cosmetics, SA GLYCERIN 4 mg/mL N 20181231 20151-105_524e2ab3-be14-5f15-e054-00144ff88e88 20151-105 HUMAN OTC DRUG Lightening High Sun Protection Cream Octocrylene, titanium dioxide, avobenzone CREAM TOPICAL 20170329 OTC MONOGRAPH NOT FINAL part352 Casmara Cosmetics, SA TITANIUM DIOXIDE; AVOBENZONE; OCTOCRYLENE 5.1; 4; 10 mg/mL; mg/mL; mg/mL N 20181231 20276-044_387a6f02-4f35-0888-e054-00144ff8d46c 20276-044 HUMAN OTC DRUG Lucky Daily Moisturizing dimethicone LOTION TOPICAL 20130131 OTC MONOGRAPH FINAL part347 Delta Brands Inc DIMETHICONE 1 g/100mL N 20181231 20276-045_e148135d-5838-4188-9ed9-fbb1ba14106c 20276-045 HUMAN OTC DRUG Lucky Classic pyrithione zinc SHAMPOO TOPICAL 20120630 OTC MONOGRAPH FINAL part358H Delta Brands Inc PYRITHIONE ZINC .3 mL/100mL E 20171231 20276-046_57148bde-b0d5-4920-bb13-ff02420f54c1 20276-046 HUMAN OTC DRUG Lucky 2in1 Classic pyrithione zinc SHAMPOO TOPICAL 20120630 OTC MONOGRAPH FINAL part358H Delta Brands Inc PYRITHIONE ZINC .3 mL/100mL N 20181231 20276-047_2f971ee5-aa40-48df-9fc4-2b8c631907f8 20276-047 HUMAN OTC DRUG Lucky Dry Hair pyrithione zinc SHAMPOO TOPICAL 20120630 OTC MONOGRAPH FINAL part358H Delta Brands Inc PYRITHIONE ZINC .3 mL/100mL E 20171231 20276-048_30c91b5f-3525-6b70-e054-00144ff8d46c 20276-048 HUMAN OTC DRUG Lucky antibacterial deodorant Triclocarban SOAP TOPICAL 20160415 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc. TRICLOCARBAN .3 g/100g E 20171231 20276-049_441e4da8-1368-530a-e054-00144ff88e88 20276-049 HUMAN OTC DRUG Lucky antibacterial deodorant Benzalkonium Chloride SOAP TOPICAL 20161215 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 20276-050_5f5955a9-8b67-43d7-9cf4-c872a4823640 20276-050 HUMAN OTC DRUG Lucky Antibacterial Deodorant Triclosan SOAP TOPICAL 20120621 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc. TRICLOSAN .2 g/100g E 20171231 20276-051_25399e80-18de-0d10-e054-00144ff8d46c 20276-051 HUMAN OTC DRUG Lucky Hand Sanitizer with Vitamin E Ethyl Alcohol LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc. ALCOHOL 70 mL/100mL N 20181231 20276-052_2679d460-2440-6b15-e054-00144ff88e88 20276-052 HUMAN OTC DRUG Lucky Hand Sanitizer with Aloe Vera Ethyl Alcohol LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc. ALCOHOL 70 mL/100mL N 20181231 20276-053_3a8de065-9a88-43e9-969e-620cfccf2c97 20276-053 HUMAN OTC DRUG Lucky Hand Sanitizer Lavender Ethyl Alcohol LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc. ALCOHOL 70 mL/100mL N 20181231 20276-054_73dc9831-bbe5-4fa5-adb2-fd8e258e2866 20276-054 HUMAN OTC DRUG Lucky Hand Sanitizer Citrus Zest Ethyl Alcohol LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc. ALCOHOL 70 mL/100mL E 20171231 20276-100_964a2c4c-9d75-4ca5-8873-63b27161183b 20276-100 HUMAN OTC DRUG Chestrub Camphor Menthol Eucalyptus Oil OINTMENT TOPICAL 20091115 OTC MONOGRAPH NOT FINAL part348 Delta Brands Inc CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.7; 1; 1 g/100g; g/100g; g/100g N 20181231 20276-102_5fe0531e-7caa-49bd-b91b-e6cf1b593c64 20276-102 HUMAN OTC DRUG Lucky SuperSoft MAXIMUM STRENGTH Hydrocortisone CREAM TOPICAL 20150131 OTC MONOGRAPH NOT FINAL part348 Delta Brands, Inc HYDROCORTISONE 1 g/100g N 20181231 20276-103_0dcee094-fce0-4d8c-b05b-86c28b1eaea6 20276-103 HUMAN OTC DRUG Lucky SuperSoft First Aid Bacitracin Neomycin Polymyxin B OINTMENT TOPICAL 20150131 OTC MONOGRAPH FINAL part333B Delta Brands, Inc BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 20276-104_8ff1c953-ec15-429a-b16e-df553d25e3a6 20276-104 HUMAN OTC DRUG Lucky SuperSoft First Aid Bacitracin Zinc OINTMENT TOPICAL 20150131 OTC MONOGRAPH FINAL part333B Delta Brands Inc BACITRACIN ZINC 500 [USP'U]/g N 20181231 20276-105_ef43d198-d049-47da-b996-1cfbcb8ad3ac 20276-105 HUMAN OTC DRUG Lucky SuperSoft Athletes Foot Clotrimazole CREAM TOPICAL 20150131 OTC MONOGRAPH FINAL part333C Delta Brands, Inc CLOTRIMAZOLE 1 g/100g N 20181231 20276-106_2beb218c-40d4-465f-b15f-56dcd03ab0ac 20276-106 HUMAN OTC DRUG Lucky SuperSoft Muscle and Joint Camphor Menthol Methyl Salicylate CREAM TOPICAL 20150131 OTC MONOGRAPH NOT FINAL part348 Delta Brands Inc CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g N 20181231 20276-107_712bffe4-ae73-4659-a2b8-2754bc66e574 20276-107 HUMAN OTC DRUG Lucky SuperSoft Mineral oil Petrolatum Phenylephrine HCl OINTMENT TOPICAL 20150131 OTC MONOGRAPH FINAL part346 Delta Brands Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE .25; .25; .25 g/100g; g/100g; g/100g N 20181231 20276-120_8e694983-812a-471c-b1c8-0b2ad5ded88a 20276-120 HUMAN OTC DRUG LUCKY SUPER SOFT Vitamin E White Petrolatum CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 Delta Brands Inc PETROLATUM 30 g/100g N 20181231 20276-121_9824c6e8-8419-4130-91ad-7f7c545f77a3 20276-121 HUMAN OTC DRUG LUCKY SUPER SOFT Cocoa Butter White Petrolatum CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 Delta Brands Inc PETROLATUM 30 g/100g N 20181231 20276-143_51da6bc6-b5a1-0e7f-e054-00144ff88e88 20276-143 HUMAN OTC DRUG LUCKY antibacterial foaming handwash Benzalkonium chloride LIQUID TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 20276-144_4af3e28d-98db-018c-e054-00144ff88e88 20276-144 HUMAN OTC DRUG LUCKY antibacterial Benzalkonium chloride LIQUID TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 20276-145_4af45594-ccbf-7363-e054-00144ff8d46c 20276-145 HUMAN OTC DRUG LUCKY antibacterial Benzalkonium chloride LIQUID TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 20276-146_4af491ff-c21b-15dd-e054-00144ff88e88 20276-146 HUMAN OTC DRUG LUCKY antibacterial Benzalkonium chloride LIQUID TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 20276-147_3283c8d4-9cc9-5d50-e054-00144ff8d46c 20276-147 HUMAN OTC DRUG LUCKY antibacterial Benzalkonium chloride LIQUID TOPICAL 20160510 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 20276-148_34b627f2-3884-1c38-e054-00144ff8d46c 20276-148 HUMAN OTC DRUG LUCKY SUPER SOFT HAND SANITIZER Benzalkonium chloride LIQUID TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 20276-149_7a9aaeac-cc0c-4199-8dc1-c170e9a41d9b 20276-149 HUMAN OTC DRUG Lucky SuperSoft FOAMING HAND SANITIZER Benzalkonium chloride LIQUID TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 20276-150_353f09bd-67d3-5ced-e054-00144ff88e88 20276-150 HUMAN OTC DRUG Lucky Instant Hand Sanitizer with Vitamin E and Moisturizers Ethyl Alcohol LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333E Delta Brands Inc ALCOHOL 62 mL/100mL N 20181231 20276-152_993a50e3-7948-4ef2-90e5-325fa125965c 20276-152 HUMAN OTC DRUG Lucky Instant Hand Sanitizer with Vitamin E Ethyl Alcohol LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc ALCOHOL 62 mL/100mL E 20171231 20276-154_b3c0a25b-784d-4d73-b2c9-3ba2c38d6125 20276-154 HUMAN OTC DRUG Lucky Instant Hand Sanitizer with Aloe Vera Ethyl Alcohol LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc ALCOHOL 62 mL/100mL E 20171231 20276-155_28834f79-d0be-4ca5-b632-82b7d825a63f 20276-155 HUMAN OTC DRUG Lucky Instant Hand Cleanser with Vitamin E Ethyl Alcohol LIQUID TOPICAL 20091208 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc ALCOHOL 62 mL/100mL E 20171231 20276-156_1305a3e9-82ed-4c4e-aa98-2e905297ece6 20276-156 HUMAN OTC DRUG Lucky Instant Hand Sanitizer Citrus Zest Ethyl Alcohol LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc ALCOHOL 62 mL/100mL E 20171231 20276-157_6fc43064-aa85-4908-9b81-2b9d3b1d2dce 20276-157 HUMAN OTC DRUG Lucky Instant Hand Cleanser with Aloe Vera Ethyl Alcohol LIQUID TOPICAL 20091208 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc ALCOHOL 62 mL/100mL E 20171231 20276-158_270ce0d4-8ede-41be-bbfd-5ee592dff801 20276-158 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL E 20171231 20276-159_b33569e5-e611-42fc-843d-1ef69bede8ba 20276-159 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL E 20171231 20276-160_f3773273-2ffc-473d-b274-883d225540f4 20276-160 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL E 20171231 20276-161_2db0ca67-b0aa-4111-b3b7-ef4a8c33d93e 20276-161 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL E 20171231 20276-162_6ee2584d-05b8-48f0-b48e-be26737cd24f 20276-162 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL E 20171231 20276-163_c4a1aff4-6cd4-4b71-b229-8d1a69f9d481 20276-163 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL E 20171231 20276-164_15cc8f99-1238-4d26-8052-cb32472d09dd 20276-164 HUMAN OTC DRUG Lucky Antibacterial Hand Soap Supersoft Triclosan LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Delta Brands Inc TRICLOSAN .1 mL/100mL E 20171231 20276-165_76768c34-7f97-4cc1-9b28-f843d131045f 20276-165 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan LIQUID TOPICAL 20110930 OTC MONOGRAPH NOT FINAL part333E Delta Brands Inc TRICLOSAN .1 mL/100mL N 20181231 20276-166_dd7c48f4-30b4-4b78-8a69-d35835362795 20276-166 HUMAN OTC DRUG Lucky Supersoft Antibacterial Hand Triclosan SOAP TOPICAL 20140107 OTC MONOGRAPH NOT FINAL part333A Delta Brands Inc TRICLOSAN .15 g/100mL E 20171231 20276-200_3125d08e-05b3-4072-ae53-7f6a4e851fb5 20276-200 HUMAN OTC DRUG Lucky Supersoft Oil Free Acne Wash Salicylic Acid LIQUID TOPICAL 20110815 OTC MONOGRAPH FINAL part333D Delta Brands Inc SALICYLIC ACID 2 mL/100mL N 20181231 20276-210_2b72623f-1647-6613-e054-00144ff8d46c 20276-210 HUMAN OTC DRUG Lucky Blue Ice Menthol Camphor GEL TOPICAL 20091115 OTC MONOGRAPH NOT FINAL part348 Delta Brands Inc MENTHOL; CAMPHOR (SYNTHETIC) 1; .5 g/100g; g/100g N 20181231 20276-321_8d9d0473-ad5b-477f-a172-361241614d4c 20276-321 HUMAN OTC DRUG My Fair Baby Diaper Rash Zinc Oxide CREAM TOPICAL 20110830 OTC MONOGRAPH FINAL part347 Delta Brands Inc ZINC OXIDE 13 g/100g N 20181231 20276-325_4c4c9857-e9b8-4883-aca1-ecdd6f793448 20276-325 HUMAN OTC DRUG Lucky Itch Stopping Diphenhydramine hydrochloride Zinc acetate CREAM TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part348 Delta Brands Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 20276-326_330c47f6-f479-7390-e054-00144ff88e88 20276-326 HUMAN OTC DRUG Lucky SuperSoft with Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20160509 OTC MONOGRAPH FINAL part347 Delta Brands, Inc PETROLATUM; LANOLIN 53.4; 15.5 g/100g; g/100g N 20181231 20276-330_4cd23299-cafa-239b-e054-00144ff88e88 20276-330 HUMAN OTC DRUG Lucky Epsom Salt magnesium sulfate GRANULE ORAL 20160905 OTC MONOGRAPH NOT FINAL part334 Delta Brands Inc MAGNESIUM SULFATE, UNSPECIFIED FORM 100 g/100g N 20181231 20276-430_5cf661ed-5f51-4540-83a5-f8e9b879fefe 20276-430 HUMAN OTC DRUG Lucky Sanitizing Hand Towels Alcohol CLOTH TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc ALCOHOL 62 mg/1 E 20171231 20276-431_5b5b4a07-334a-4b98-e053-2991aa0ae636 20276-431 HUMAN OTC DRUG Wet Wipes Benzalkonium chloride SWAB TOPICAL 20070123 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZALKONIUM CHLORIDE .1 g/1 N 20181231 20276-432_060b5282-99e7-4bc1-b4ce-564a1da0d0ac 20276-432 HUMAN OTC DRUG Wet Wipes Benzethonium chloride SWAB TOPICAL 20110429 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZETHONIUM CHLORIDE .3 mL/1 N 20181231 20276-433_8339d4f6-63fd-44aa-9e88-cc3999488802 20276-433 HUMAN OTC DRUG Wet Wipes Benzethonium chloride SWAB TOPICAL 20110529 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZETHONIUM CHLORIDE .3 mL/1 E 20171231 20276-434_2e592569-4a6a-31f7-e054-00144ff88e88 20276-434 HUMAN OTC DRUG Lucky SuperSoft Wet Wipes Benzalkonium chloride CLOTH TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part333A Delta Brands, Inc BENZALKONIUM CHLORIDE .1 g/1 E 20171231 20276-505_32837937-0db2-09a9-e054-00144ff88e88 20276-505 HUMAN OTC DRUG Petroleum Jelly White Petrolatum OINTMENT TOPICAL 20110530 OTC MONOGRAPH FINAL part347 Delta Brands Inc. PETROLATUM 1 g/g N 20181231 20276-550_53bbd4f8-22fe-09b5-e054-00144ff88e88 20276-550 HUMAN OTC DRUG Lucky Super Soft Sensitive Sodium fluoride Potassium Nitrate PASTE, DENTIFRICE DENTAL 20140227 OTC MONOGRAPH NOT FINAL part356 Delta Brands Inc POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.4 mg/g; mg/g N 20181231 20276-551_53bbd4f8-230b-09b5-e054-00144ff88e88 20276-551 HUMAN OTC DRUG Lucky Super Soft Anti Cavity with Free Toothbrush Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20140227 OTC MONOGRAPH FINAL part355 Delta Brands Inc SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 20276-552_53bbd4f8-2314-09b5-e054-00144ff88e88 20276-552 HUMAN OTC DRUG Lucky Super Soft Whitening Anti Cavity with Free Toothbrush Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20140227 OTC MONOGRAPH FINAL part355 Delta Brands Inc SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 20276-553_53bbe10e-3a1b-106d-e054-00144ff88e88 20276-553 HUMAN OTC DRUG Lucky Super Soft Whitening Anti Cavity Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20170331 OTC MONOGRAPH FINAL part355 Delta Brands Inc SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 20276-554_53bbd4f8-22f3-09b5-e054-00144ff88e88 20276-554 HUMAN OTC DRUG Lucky Super Soft Anti Cavity Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20170331 OTC MONOGRAPH FINAL part355 Delta Brands Inc SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 20276-560_00e02dfa-892d-4095-bcee-a3dd2bca05f5 20276-560 HUMAN OTC DRUG My Fair Baby Instant Pain Relief Benzocaine GEL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part356 Delta Brands Inc BENZOCAINE 7.5 g/100g E 20171231 20276-561_6d3a3406-d5f3-4d7d-8898-79d9a4682776 20276-561 HUMAN OTC DRUG Lucky Oral Pain Relief Benzocaine Benzalkonium Chloride GEL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part356 Delta Brands Inc BENZOCAINE; BENZALKONIUM CHLORIDE 20; .1 g/100g; g/100g N 20181231 20276-700_3fb479a3-ae9a-1b06-e054-00144ff8d46c 20276-700 HUMAN OTC DRUG CLARISSE Antiperspirant Deodorant Daily Protection Aluminum chlorohydrate STICK TOPICAL 20161017 OTC MONOGRAPH FINAL part350 Delta Brands Inc ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 20276-814_a22b3be0-204a-4cd7-a2e7-69deb89d114a 20276-814 HUMAN OTC DRUG Petroleum Jelly Scented White Petrolatum OINTMENT TOPICAL 20110530 OTC MONOGRAPH FINAL part347 Delta Brands Inc. PETROLATUM 99.9 g/100g N 20181231 20276-815_889a4633-7563-4a7a-b464-03e5bca3b7ab 20276-815 HUMAN OTC DRUG Petroleum Jelly Scented White Petrolatum OINTMENT TOPICAL 20130413 OTC MONOGRAPH FINAL part347 Delta Brands Inc. PETROLATUM 99.9 g/100g N 20181231 20276-979_37f1a9b2-eb4f-6b64-e054-00144ff88e88 20276-979 HUMAN OTC DRUG Lucky Supersoft Premium Menthol Zinc Oxide POWDER TOPICAL 20101025 OTC MONOGRAPH NOT FINAL part348 Delta Brands Inc MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g N 20181231 20276-980_603bd721-e4c7-feee-e053-2a91aa0aa315 20276-980 HUMAN OTC DRUG Lucky Supersoft Medicated Body Triple Action Menthol Zinc Oxide POWDER TOPICAL 20171211 OTC MONOGRAPH NOT FINAL part348 Delta Brands Inc MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g N 20181231 20367-111_cdec2548-5700-447b-9398-2bb70ddbd769 20367-111 HUMAN OTC DRUG Rayito de Sol Sunscreen SPF 6 Octisalate Oxybenzone CREAM TOPICAL 20110214 OTC MONOGRAPH FINAL part352 Siscom de Argentina SA OCTISALATE; OXYBENZONE 2.8; .7 g/70g; g/70g E 20171231 20367-113_aa6f3dd2-74ab-4c29-b48d-83e9c1d964a9 20367-113 HUMAN OTC DRUG Rayito de Sol Sunscreen SPF 18 Octisalate Oxybenzone Padimate O CREAM TOPICAL 20110214 OTC MONOGRAPH FINAL part352 Siscom de Argentina SA OCTISALATE; OXYBENZONE; PADIMATE O 2.8; 4.2; 4.2 g/70g; g/70g; g/70g E 20171231 20367-132_a992a8a3-4f24-486c-9243-bdcd6ccf3094 20367-132 HUMAN OTC DRUG Rayito de Sol Ensulizole, Sulisobenzone GEL TOPICAL 20121224 OTC MONOGRAPH FINAL part352 Siscom de Argentina S.A. ENSULIZOLE; SULISOBENZONE 4; 4 g/200g; g/200g E 20171231 20367-133_5dd84112-9478-4dba-8920-4fb47cbcb4fd 20367-133 HUMAN OTC DRUG Rayito de Sol Ensulizole, Sulisobenzone GEL TOPICAL 20121224 OTC MONOGRAPH FINAL part352 Siscom de Argentina S.A. ENSULIZOLE; SULISOBENZONE 4; 4 g/200g; g/200g E 20171231 20367-134_ca16f393-2014-40df-9545-14e5858b16ad 20367-134 HUMAN OTC DRUG Rayito de Sol SPF 35 OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130111 OTC MONOGRAPH FINAL part352 Siscom de Argentina S.A. OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; TITANIUM DIOXIDE 15.04; 9.68; 9.68; 7.21; 1.24 g/200mL; g/200mL; g/200mL; g/200mL; g/200mL E 20171231 20479-0682_44a02913-e60b-465d-b5d7-48561c42825f 20479-0682 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Hometown Medical LLC OXYGEN 99 L/100L E 20171231 20482-001_3477c8ae-1178-4c63-8772-355c7d47f930 20482-001 HUMAN PRESCRIPTION DRUG SUBSYS fentanyl SPRAY SUBLINGUAL 20120313 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .1 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 20482-002_3477c8ae-1178-4c63-8772-355c7d47f930 20482-002 HUMAN PRESCRIPTION DRUG SUBSYS fentanyl SPRAY SUBLINGUAL 20120313 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 20482-004_3477c8ae-1178-4c63-8772-355c7d47f930 20482-004 HUMAN PRESCRIPTION DRUG SUBSYS fentanyl SPRAY SUBLINGUAL 20120313 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 20482-006_3477c8ae-1178-4c63-8772-355c7d47f930 20482-006 HUMAN PRESCRIPTION DRUG SUBSYS fentanyl SPRAY SUBLINGUAL 20120313 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .6 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 20482-008_3477c8ae-1178-4c63-8772-355c7d47f930 20482-008 HUMAN PRESCRIPTION DRUG SUBSYS fentanyl SPRAY SUBLINGUAL 20120313 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 20482-012_3477c8ae-1178-4c63-8772-355c7d47f930 20482-012 HUMAN PRESCRIPTION DRUG SUBSYS fentanyl SPRAY SUBLINGUAL 20120830 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .6 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 20482-016_3477c8ae-1178-4c63-8772-355c7d47f930 20482-016 HUMAN PRESCRIPTION DRUG SUBSYS fentanyl SPRAY SUBLINGUAL 20120830 NDA NDA202788 Insys Therapeutics, Inc. FENTANYL .8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 20482-335_40ab1c64-b842-4a71-baf4-eab1b5e365eb 20482-335 HUMAN PRESCRIPTION DRUG SYNDROS Dronabinol SOLUTION ORAL 20170727 NDA NDA205525 Insys Therapeutics, Inc. DRONABINOL 5 mg/mL Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] N 20181231 20536-322_bd0c0144-cfb7-4ad3-bfcb-7243c636abf4 20536-322 HUMAN PRESCRIPTION DRUG Marqibo Vincristine Sulfate KIT 20130114 NDA NDA202497 Talon Therapeutics, Inc. N 20181231 20703-001_f14ead9b-09cb-41fe-be73-671722c3d274 20703-001 HUMAN PRESCRIPTION DRUG nitrogen nitrogen GAS RESPIRATORY (INHALATION) 19840101 NDA NDA205850 General Welding Supply Corp. NITROGEN 999 mL/L N 20181231 20703-002_320789a7-3287-4a93-a92f-b8939fe9a53b 20703-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19840101 NDA NDA205849 General Welding Supply Corp. OXYGEN 995 mL/L N 20181231 20703-003_cf121717-9575-478a-bef6-61d3f92ffb65 20703-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19840101 NDA NDA209989 General Welding Supply Corp. NITROUS OXIDE 990 mL/L N 20181231 20802-1500_89aaa721-8b3c-4167-8758-d5e41d05a430 20802-1500 HUMAN OTC DRUG Fresh Protect Skin Sanitizer Benzalkonium Chloride LOTION TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333A Omega Tech Labs Inc. BENZALKONIUM CHLORIDE .0013 g/mL E 20171231 20802-1501_f3475182-3cd1-44b2-be07-cbcb554f4b55 20802-1501 HUMAN OTC DRUG Fresh Protect Skin Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333A Omega Tech Labs Inc. BENZALKONIUM CHLORIDE .001 g/mL E 20171231 20802-1502_a7159bc5-8b7a-4763-8c90-3182be730f87 20802-1502 HUMAN OTC DRUG Fresh Protect Skin Sanitizer Benzalkonium Chloride SPRAY TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333A Omega Tech Labs Inc. BENZALKONIUM CHLORIDE .001 g/mL E 20171231 20802-1503_f3475182-3cd1-44b2-be07-cbcb554f4b55 20802-1503 HUMAN OTC DRUG Fresh Protect Skin Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333A Omega Tech Labs Inc. BENZALKONIUM CHLORIDE .001 g/mL E 20171231 20890-0020_6cc082b1-ae18-49ed-a51b-d1c5c28792ee 20890-0020 HUMAN OTC DRUG Lander Polar Ice Menthol GEL TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part356 Abaco Partners LLC DBA Surefil MENTHOL 20 mg/g E 20171231 20890-0040_8751b62e-1db1-4b33-b0e6-3e465b6add20 20890-0040 HUMAN OTC DRUG TopCare Antibacterial Hand Light Moisturizers Benzalkonium Chloride SOAP TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part333E Abaco Partners LLC DBA Surefil BENZALKONIUM CHLORIDE 2.34 mg/1.8mL N 20181231 20890-0050_c151a0dc-d02b-41bd-8aae-55bc2497f6e7 20890-0050 HUMAN OTC DRUG TopCare Amber Antibacterial Hand Benzalkonium Chloride SOAP TOPICAL 20141215 OTC MONOGRAPH NOT FINAL part333E Abaco Partners LLC DBA Surefil BENZALKONIUM CHLORIDE 13 mg/10mL N 20181231 20890-0060_6921d93b-d41e-4643-b2ef-8b159572acb9 20890-0060 HUMAN OTC DRUG TopCare Citrus Antibacterial Hand Benzalkonium Chloride SOAP TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part333E Abaco Partners LLC DBA Surefil BENZALKONIUM CHLORIDE 13 mg/10mL N 20181231 20890-0091_b3bcfa01-4466-4d31-84c8-b85059fd264c 20890-0091 HUMAN OTC DRUG Reeva Green Apple Antibacterial Hand Chloroxylenol SOAP TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part333A Abaco Partners LLC DBA Surefil CHLOROXYLENOL 30 mg/10mL N 20181231 20890-0100_78bd09e9-0143-4865-a87f-fe289baad897 20890-0100 HUMAN OTC DRUG TopCare Antibacterial Berry Blast Foaming Hand Benzalkonium Chloride SOAP TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part333E Abaco Partners LLC DBA Surefil BENZALKONIUM CHLORIDE 13 mg/10mL N 20181231 20890-0110_b8548277-4afa-42ea-a2b0-51a22cc9fffc 20890-0110 HUMAN OTC DRUG TopCare Antibacterial Cucumber Melon Foaming Hand Benzalkonium Chloride SOAP TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part333E Abaco Partners LLC DBA Surefil BENZALKONIUM CHLORIDE 13 mg/10mL N 20181231 20890-0120_b97a24db-e687-488c-9c68-3005d9d105c4 20890-0120 HUMAN OTC DRUG TopCare Antibacterial White Tea Foaming Hand Benzalkonium Chloride SOAP TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part333E Abaco Partners LLC DBA Surefil BENZALKONIUM CHLORIDE 13 mg/10mL N 20181231 20890-0130_ed4dfdc2-f7f1-4b1d-b8b6-b7a8a743032a 20890-0130 HUMAN OTC DRUG TopCare Antibacterial Spring Water Foaming Hand Benzalkonium Chloride SOAP TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part333E Abaco Partners LLC DBA Surefil BENZALKONIUM CHLORIDE 13 mg/10mL N 20181231 20890-0140_bf29879e-d90f-4966-92c8-68bdd4b19bcf 20890-0140 HUMAN OTC DRUG TopCare Antibacterial Complete Foaming Hand Benzalkonium Chloride SOAP TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part333E Abaco Partners LLC DBA Surefil BENZALKONIUM CHLORIDE 13 mg/10mL N 20181231 20890-0150_a6d45c7f-cd87-45ce-ae54-2d640128b48d 20890-0150 HUMAN OTC DRUG TopCare Antibacterial Fresh Pear Foaming Hand Benzalkonium Chloride SOAP TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part333E Abaco Partners LLC DBA Surefil BENZALKONIUM CHLORIDE 13 mg/10mL N 20181231 21130-000_6b5a7263-79a0-4301-b183-a3b3a7121f2e 21130-000 HUMAN OTC DRUG Stool Softener plus Stimulant Laxative Docusate sodium and Sennosides TABLET ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 Safeway, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 21130-003_e4847637-95c0-41a5-a424-dec6a536d2f8 21130-003 HUMAN OTC DRUG Acid Reducer Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20131213 ANDA ANDA201745 SAFEWAY INC. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 21130-004_c29409b7-c8dd-44a1-8ff2-a00e0db5d0d3 21130-004 HUMAN OTC DRUG Nighttime Sleep-Aid Diphenhydramine HCl 25 mg CAPSULE ORAL 20141231 OTC MONOGRAPH FINAL part338 Safeway, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 21130-005_462a4ff2-2ca1-4540-9270-e93abbe29aff 21130-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Safeway SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 21130-007_ccf60557-4463-4111-8e33-0511f42697a0 21130-007 HUMAN OTC DRUG Signature Care Allergy and Congestion Relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20151030 ANDA ANDA076050 Safeway LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 21130-009_78808b6e-34c4-4114-8f98-344e2d38d53a 21130-009 HUMAN OTC DRUG 4 Hour Allergy Relief Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 21130-011_117900ff-eaa4-4a70-aa2a-132d8c1f6abf 21130-011 HUMAN OTC DRUG signature care childrens ibuprofen Ibuprofen SUSPENSION ORAL 20150901 ANDA ANDA074937 Safeway IBUPROFEN 100 mg/5mL N 20181231 21130-014_db17939a-63f9-498a-a244-5412c48fd857 21130-014 HUMAN OTC DRUG EZ Nite Sleep Diphenhydramine HCl LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Safeway, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 21130-015_3b902ece-28dd-47e1-829f-f0a366441a5f 21130-015 HUMAN OTC DRUG signature care infants gas relief Simethicone EMULSION ORAL 20150904 OTC MONOGRAPH FINAL part332 Safeway DIMETHICONE 20 mg/.3mL N 20181231 21130-016_3e7ff599-7504-4277-9970-f64ebef47bc7 21130-016 HUMAN OTC DRUG Signature Care Pain Relief Naproxen Sodium TABLET ORAL 20151024 ANDA ANDA074661 Safeway NAPROXEN SODIUM 220 mg/1 N 20181231 21130-017_9ed927c7-08fe-41a2-91af-324d97a0d2d6 21130-017 HUMAN OTC DRUG Hand wash Benzalkonium chloride SOAP TOPICAL 20150728 OTC MONOGRAPH NOT FINAL part333A Better Living Brands LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 21130-019_ef523ae9-f41b-4faf-8a6f-6cd4538e6be1 21130-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20121231 ANDA ANDA202727 Safeway, Inc. LANSOPRAZOLE 15 mg/1 E 20171231 21130-020_12d58c8b-36a4-447c-ab51-749dce23ecc5 21130-020 HUMAN OTC DRUG Signature Care severe cold cough and flu Nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20151027 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 21130-024_a670f1ec-5a77-437c-be65-0d62f5cd13eb 21130-024 HUMAN OTC DRUG Childrens Mucus Relief DM Dextromethorphan HBr, Guaifensin LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 21130-025_5f22c67c-0862-4cc2-b8c4-ad16cdf08841 21130-025 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20090203 OTC MONOGRAPH FINAL part341 Safeway, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 21130-026_4346814f-4139-4081-9734-4385030907ba 21130-026 HUMAN OTC DRUG Signature Care Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20150929 ANDA ANDA076359 Safeway IBUPROFEN 100 mg/1 N 20181231 21130-030_c97b4111-b64c-4321-901a-8b7d057fb093 21130-030 HUMAN OTC DRUG Signature Care Ibuprofen PM Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20151113 ANDA ANDA079113 Safeway DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 21130-034_eadfa97f-4747-4384-9f69-b414b70e34e6 21130-034 HUMAN OTC DRUG Childrens Plus Multi Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride SUSPENSION ORAL 20150630 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 21130-035_16ba2996-bec0-4caa-82c1-05d01e56fe6d 21130-035 HUMAN OTC DRUG Signature Care Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20150901 ANDA ANDA074937 Safeway IBUPROFEN 100 mg/5mL N 20181231 21130-036_4e14f526-f088-44dd-b6bf-d92bbeb31794 21130-036 HUMAN OTC DRUG Cold Flu and Sore Throat Relief Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 21130-040_59512155-7555-41c7-8aa5-52b733c9001d 21130-040 HUMAN OTC DRUG Signature Care Miconazole 1 Miconazole nitrate KIT 20150928 ANDA ANDA079114 Safeway N 20181231 21130-044_e3792f49-d0dd-40c7-8d12-eae0ece12f8b 21130-044 HUMAN OTC DRUG Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 21130-053_025edd6f-d9d8-4b12-8672-47b1a90b7754 21130-053 HUMAN OTC DRUG SAFEWAY CARE HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20131213 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 650 mg/mL N 20181231 21130-053_c3f61513-d6f4-4e16-a459-df346c7e460f 21130-053 HUMAN OTC DRUG SAFEWAY CARE HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 650 mg/mL N 20181231 21130-053_f8b2384a-c357-42fc-8eeb-99b419acf8af 21130-053 HUMAN OTC DRUG SAFEWAY CARE HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 650 mg/mL N 20181231 21130-060_7370f57a-475a-4188-9b3e-a2f4e5b97f4a 21130-060 HUMAN OTC DRUG signature care tioconazole 1 Tioconazole OINTMENT VAGINAL 20150924 ANDA ANDA075915 Safeway TIOCONAZOLE 6.5 g/100g N 20181231 21130-063_3b2686fe-8679-47af-8fb5-0467f7515713 21130-063 HUMAN OTC DRUG SAFEWAY Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Safeway Inc. HYDROCORTISONE 1 g/100g N 20181231 21130-065_149eb141-f4cf-4cad-a019-b3382758e7b6 21130-065 HUMAN OTC DRUG nasal decongestant Oxymetazoline HCl SPRAY NASAL 19940817 OTC MONOGRAPH FINAL part341 Safeway OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 21130-069_5276f351-dabd-46ba-a5d3-de7ebf34d58f 21130-069 HUMAN OTC DRUG Pure petroleum White Petrolatum JELLY TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Better Living Branes LLC PETROLATUM 1 g/g N 20181231 21130-071_ea94d409-83a2-4d34-b0cb-0729910f3864 21130-071 HUMAN OTC DRUG Cold and Flu Relief Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20160229 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 21130-072_e4d3e716-4fc3-436f-bd18-cc5bca131a1d 21130-072 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19980325 OTC MONOGRAPH NOT FINAL part356 Better Living Brands LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 21130-075_32493b4c-9b11-4fe8-bc92-5c1ff4c2e976 21130-075 HUMAN OTC DRUG Safeway Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Safeway Inc. BACITRACIN ZINC 500 [iU]/g N 20181231 21130-076_73ba9788-7b61-444d-aee1-67b896dc3c57 21130-076 HUMAN OTC DRUG Safeway Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Safeway Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 21130-078_56e2d813-668e-4b5f-b91b-94f344387806 21130-078 HUMAN OTC DRUG Signature Care Castor OIL ORAL 20151116 OTC MONOGRAPH NOT FINAL part334 Better Living Brands, LLC CASTOR OIL 1 g/mL N 20181231 21130-080_696060f2-0fe7-4f4d-a9ed-513c4ec083f3 21130-080 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Safeway Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 21130-081_1d31340b-bec4-44bb-e054-00144ff8d46c 21130-081 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength Aspirin TABLET, DELAYED RELEASE ORAL 20150805 OTC MONOGRAPH NOT FINAL part343 Safeway ASPIRIN 325 mg/1 N 20181231 21130-082_c8e81c0c-5459-4f74-bdb4-9d3cbfc77b28 21130-082 HUMAN OTC DRUG Signature Care Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20160205 OTC MONOGRAPH FINAL part341 Safeway BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 21130-084_028efc97-e5e7-4ddc-8716-4bb4930113c5 21130-084 HUMAN OTC DRUG SAFEWAY CARE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 650 mg/mL N 20181231 21130-084_388d526d-9a60-41a5-abb8-e6a286127193 21130-084 HUMAN OTC DRUG SAFEWAY CARE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20140122 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 650 mg/mL N 20181231 21130-084_e6f38082-ae9c-4fc8-9bc9-5ec1b97f053c 21130-084 HUMAN OTC DRUG SAFEWAY CARE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131124 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 650 mg/mL N 20181231 21130-085_656509ef-db76-4ee7-aef1-34740c53b5b4 21130-085 HUMAN OTC DRUG Signature Care Lice Treatment Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20151111 OTC MONOGRAPH FINAL part358G Safeway PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 21130-086_6530e4c5-ab9f-47ac-b999-6890f27f089b 21130-086 HUMAN OTC DRUG Signature Care Mucus Relief Max Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160812 ANDA ANDA091009 Safeway GUAIFENESIN 1200 mg/1 N 20181231 21130-087_249b19fd-d5b3-4c93-92bb-f277797015b4 21130-087 HUMAN OTC DRUG Signature Care Acid Reducer Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160302 ANDA ANDA077355 Safeway FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 21130-088_238b27e3-6993-4213-b7eb-062309398d1b 21130-088 HUMAN OTC DRUG signature care esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170922 ANDA ANDA207193 Safeway ESOMEPRAZOLE 20 mg/1 N 20181231 21130-089_8242a4be-8a11-4dc8-b31c-dc8da8466b8e 21130-089 HUMAN OTC DRUG Signature Care Allergy Relief Fluticasone propionate SPRAY, METERED NASAL 20160531 ANDA ANDA207957 Safeway FLUTICASONE PROPIONATE 50 ug/1 N 20181231 21130-090_c23ed5f8-ad52-4d2b-92ba-0525e511c8aa 21130-090 HUMAN OTC DRUG signature care allergy relief Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20150917 ANDA ANDA078336 Safeway CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 21130-091_f36098d1-b2e0-436f-82ed-83b66cdb1c0e 21130-091 HUMAN OTC DRUG Signature Care Non drowsy Daytime Severe Cold and Flu Relief acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20160129 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 21130-092_4e144acb-8dbe-4872-8e23-cf277d07a3e1 21130-092 HUMAN OTC DRUG Childrens Non-Drowsy 24-Hour Allergy Relief Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Safeway Inc. LORATADINE 5 mg/5mL N 20181231 21130-094_624c0e56-b21f-4cf4-987e-d40661322a43 21130-094 HUMAN OTC DRUG SAFEWAY CARE REFILL TRICLOSAN LIQUID TOPICAL 20131124 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC TRICLOSAN 1.5 mg/mL N 20181231 21130-102_3c62aea9-2a86-4034-a4ba-1b3b91fb7cba 21130-102 HUMAN OTC DRUG Signature Care Miconazole 3 Miconazole nitrate KIT 20151006 ANDA ANDA075329 Safeway N 20181231 21130-104_52b67e25-e15c-4cd5-98f5-e414f50689ad 21130-104 HUMAN OTC DRUG Aspirin Free Pain Relief Acetaminophen TABLET ORAL 19900713 20181028 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN 325 mg/1 E 20171231 21130-106_b3b19e8f-bb1d-4330-afcc-a9c59d11273d 21130-106 HUMAN OTC DRUG Safeway Children Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Safeway Inc. CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 21130-109_8b40ed11-a547-4970-a047-3a5993d288ef 21130-109 HUMAN OTC DRUG signature care allergy relief fexofenadine hcl TABLET, FILM COATED ORAL 20150811 ANDA ANDA076447 Safeway FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 21130-111_092ae916-4ef9-42c6-9a6f-1bff26264ed7 21130-111 HUMAN OTC DRUG Signature Care Pain Relief Acetaminophen TABLET ORAL 20150901 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 500 mg/1 N 20181231 21130-112_c7f8e3b4-1b33-400c-942f-e76d322f845e 21130-112 HUMAN OTC DRUG Nasal Decongestant Maximum Strength Pseudoephedrine HCl 30 mg TABLET, FILM COATED ORAL 19810825 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 21130-114_659f3859-2f0e-4ce8-9cd0-2064d0d1b332 21130-114 HUMAN OTC DRUG Signature Care Antibacterial Foaming Hand Pear Scent Triclosan SOAP TOPICAL 20160210 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC TRICLOSAN 4.6 mg/mL N 20181231 21130-115_2562b4f8-2bdb-4484-ad0d-bbabba13c06e 21130-115 HUMAN OTC DRUG Signature Care Mucus Relief DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160722 ANDA ANDA091070 Safeway DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 21130-116_cd14a5e9-0079-446c-8fd1-ea91572922bb 21130-116 HUMAN OTC DRUG Signature Care Acid Control Ranitidine TABLET, FILM COATED ORAL 20170120 ANDA ANDA091429 Safeway RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 21130-118_16041643-cd8d-4190-bc8a-285b06b5b646 21130-118 HUMAN OTC DRUG Signature Care Acid Control Ranitidine TABLET, COATED ORAL 20170210 ANDA ANDA076195 Safeway RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 21130-119_4963b197-2493-4743-a914-19e4a1bca0c5 21130-119 HUMAN OTC DRUG signature care stool softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20150904 OTC MONOGRAPH NOT FINAL part334 Safeway DOCUSATE SODIUM 100 mg/1 N 20181231 21130-120_46db4b66-85a2-47fc-a643-df6477e2ddff 21130-120 HUMAN OTC DRUG Signature Care Triple Antibiotic Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20170509 OTC MONOGRAPH FINAL part333B Safeway BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 21130-121_ab7b1901-8aaf-4a6f-bb94-885fb22b941b 21130-121 HUMAN OTC DRUG Signature Care Miconazole 7 Miconazole nitrate CREAM VAGINAL 20151103 ANDA ANDA074760 Safeway MICONAZOLE NITRATE 2 g/100g N 20181231 21130-122_e2e71016-2eb6-4fa9-a647-6185e23f5020 21130-122 HUMAN OTC DRUG signature care childrens allergy relief Fluticasone Propionate SPRAY, METERED NASAL 20170620 ANDA ANDA207957 Safeway FLUTICASONE PROPIONATE 50 ug/1 N 20181231 21130-123_f80b290f-ec60-4a0b-929b-9060ea2c5264 21130-123 HUMAN OTC DRUG Signature Care Allergy Relief Loratadine TABLET ORAL 20160208 ANDA ANDA076301 Safeway LORATADINE 10 mg/1 N 20181231 21130-126_a1e5ce11-81c3-447b-9664-e092ef6a14b6 21130-126 HUMAN OTC DRUG signature care antacid Calcium carbonate TABLET, CHEWABLE ORAL 20171102 OTC MONOGRAPH FINAL part331 Safeway CALCIUM CARBONATE 750 mg/1 N 20181231 21130-127_be3a3e69-ae35-4b09-b006-5c3a7f874982 21130-127 HUMAN OTC DRUG Antacid Relief Extra Strength Assorted Fruit Calcium antacid TABLET, CHEWABLE ORAL 20150808 OTC MONOGRAPH FINAL part331 Safeway CALCIUM CARBONATE 750 mg/1 N 20181231 21130-129_cb91e0e2-4420-4652-91bd-75af3103b105 21130-129 HUMAN OTC DRUG Signature Care Nighttime Severe Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20160124 OTC MONOGRAPH FINAL part341 Safeway ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 21130-130_2ec42acf-0444-4c12-af3b-1bc0636f0dd0 21130-130 HUMAN OTC DRUG Antacid Relief Extra Strength calcium carbonate TABLET, CHEWABLE ORAL 20150808 OTC MONOGRAPH FINAL part331 Safeway CALCIUM CARBONATE 500 mg/1 N 20181231 21130-131_bfcc6ebf-b9c1-4b96-b36e-1668c6f8bb83 21130-131 HUMAN OTC DRUG signature care anti diarrheal loperamide HCl SUSPENSION ORAL 20170927 ANDA ANDA091292 Safeway LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 21130-134_33c7b6f5-441e-47a2-bf74-f804131f528e 21130-134 HUMAN OTC DRUG Gas Relief simethicone TABLET, CHEWABLE ORAL 20150808 OTC MONOGRAPH FINAL part332 Safeway DIMETHICONE 125 mg/1 N 20181231 21130-135_f3c5efc4-6e17-44e8-9bbc-2e2f46a4177a 21130-135 HUMAN OTC DRUG Gas Relief simethicone TABLET, CHEWABLE ORAL 20151111 OTC MONOGRAPH FINAL part332 Safeway DIMETHICONE 125 mg/1 N 20181231 21130-137_6361a492-782f-4608-a20f-1bd86afbd864 21130-137 HUMAN OTC DRUG Signature Care Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20150918 NDA NDA022032 Safeway OMEPRAZOLE 20 mg/1 N 20181231 21130-142_b217491e-56e3-403e-8b73-69b4c7335d0f 21130-142 HUMAN OTC DRUG signature care vagicaine Benzocaine, Resorcinol CREAM TOPICAL 20151014 OTC MONOGRAPH NOT FINAL part348 Safeway BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g N 20181231 21130-147_9f23e74c-875b-4344-8c90-34511a4d5e85 21130-147 HUMAN OTC DRUG Fiber Laxative CALCIUM POLYCARBOPHIL TABLET ORAL 20150505 OTC MONOGRAPH NOT FINAL part334 Safeway CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 21130-148_492733a0-010d-4b0d-9e36-d166237487d9 21130-148 HUMAN OTC DRUG Triacting Day Time with PE DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20090402 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 21130-153_57e3c89f-481d-4b98-85ff-b0c4a7d47618 21130-153 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 19981208 OTC MONOGRAPH FINAL part358H Better Living Brands LLC PYRITHIONE ZINC 10 mg/mL N 20181231 21130-154_3eedcd9f-8312-4d14-a0fe-6b00a00d3e73 21130-154 HUMAN OTC DRUG signature care itch relief Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part348 Safeway DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 21130-157_09fe5369-c857-4ef1-9e7c-2ea5a409c1c5 21130-157 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 20060210 20180715 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ASPIRIN 325 mg/1 E 20171231 21130-159_2ff0de6b-fb39-4e79-a741-806f45fb609f 21130-159 HUMAN OTC DRUG Added Strength Pain Reliever Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 20180720 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 E 20171231 21130-163_0439ba78-fa34-403b-a6ef-41c2cdc0aa34 21130-163 HUMAN OTC DRUG signature care hair regrowth treatment for women Minoxidil AEROSOL, FOAM TOPICAL 20170306 ANDA ANDA091344 Safeway MINOXIDIL 50 mg/g N 20181231 21130-164_fc3ce8eb-fd3e-4f56-aa8e-70e86c9f099c 21130-164 HUMAN OTC DRUG Signature Care daytime nighttime severe cold and flu relief acetaminophen, dextromethorphan HBr, doxylamine succinate, guaifenesin, phenylephrine HCl KIT 20170601 OTC MONOGRAPH FINAL part341 Safeway N 20181231 21130-169_2b569e6d-d250-4e5a-b3ab-d2efd67d5510 21130-169 HUMAN OTC DRUG signature care antacid calcium carbonate TABLET, CHEWABLE ORAL 20171026 OTC MONOGRAPH FINAL part331 Safeway CALCIUM CARBONATE 750 mg/1 N 20181231 21130-171_4172fe9c-9c6d-49b4-8190-a2eb5be75997 21130-171 HUMAN OTC DRUG Ultra Strength Antacid Relief Assorted fruit Calcium Antacid TABLET, CHEWABLE ORAL 20150808 OTC MONOGRAPH FINAL part331 Safeway CALCIUM CARBONATE 1000 mg/1 N 20181231 21130-174_9af8643d-cf43-4e9a-b0bc-ec19d8ea92c6 21130-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20150228 NDA NDA021920 Safeway, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 21130-176_88bb6998-d148-4332-8d72-fd1203f0cb2f 21130-176 HUMAN OTC DRUG Signature Care Allergy Relief D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20151015 ANDA ANDA077170 Safeway CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 21130-177_995792ff-baeb-48cb-b9b3-fc361a545906 21130-177 HUMAN OTC DRUG Signature Care Antibacterial Foaming Moisturizing Triclosan SOAP TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC TRICLOSAN 4.6 mg/mL N 20181231 21130-181_95a7429f-302f-4ae8-bac4-033b14e3bac5 21130-181 HUMAN OTC DRUG signature care acid reducer Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20150927 ANDA ANDA202319 Safeway LANSOPRAZOLE 15 mg/1 N 20181231 21130-184_735a6c80-5923-48c9-be21-117e545deec2 21130-184 HUMAN OTC DRUG Antacid Extra Strength Assorted Berry Calcium carbonate TABLET, CHEWABLE ORAL 20150808 OTC MONOGRAPH FINAL part331 Safeway CALCIUM CARBONATE 750 mg/1 N 20181231 21130-189_c0e2d38a-221f-4ebc-9280-3b39015b4c03 21130-189 HUMAN OTC DRUG Signature Care Childrens Allergy Relief Cetirizine HCl SOLUTION ORAL 20160426 ANDA ANDA204226 Safeway CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 21130-190_5ba14287-44dd-4e48-9206-6cec668dd8ed 21130-190 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 20181113 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 21130-192_1d31340b-bed8-44bb-e054-00144ff8d46c 21130-192 HUMAN OTC DRUG Pain Relief Easy Tabs Extra Strength Acetaminophen TABLET, COATED ORAL 20150805 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 500 mg/1 N 20181231 21130-194_dfe108e6-f652-40c6-b961-74dae5fab0e6 21130-194 HUMAN OTC DRUG Acid Controller Maximum Strength Famotidine TABLET ORAL 20070615 ANDA ANDA077351 Safeway FAMOTIDINE 20 mg/1 N 20181231 21130-197_d9bb89d7-0f82-4cf2-96c7-6d9310f75a2a 21130-197 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100706 ANDA ANDA078682 Safeway, Inc. IBUPROFEN 200 mg/1 N 20181231 21130-198_c4a46ceb-e2a2-41d9-b576-a3103d19f7e6 21130-198 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Better Living Brands, LLC DIMENHYDRINATE 50 mg/1 N 20181231 21130-202_c68abe0f-b07c-445f-bb9b-cb310f4ed77a 21130-202 HUMAN OTC DRUG Antacid Relief Extra Strength Tropical Fruit Calcium antacid TABLET, CHEWABLE ORAL 20150808 OTC MONOGRAPH FINAL part331 Safeway CALCIUM CARBONATE 750 mg/1 N 20181231 21130-204_93cd12bc-4aad-48f1-8d5e-493ce0e07328 21130-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Safeway Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 21130-205_40844181-70f3-4fb3-aa7b-e6686995ad66 21130-205 HUMAN OTC DRUG Signature Care Athletes Foot Tolnaftate SPRAY TOPICAL 20151011 OTC MONOGRAPH FINAL part333C Safeway TOLNAFTATE 1 g/100g N 20181231 21130-218_166c1fa1-6330-4e8f-9b47-a015531e463d 21130-218 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, CHEWABLE ORAL 19900912 20180626 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ASPIRIN 81 mg/1 E 20171231 21130-225_71a41089-11f3-44e5-be4a-10b013b75964 21130-225 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH FINAL part338 Safeway, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 21130-226_7455f5ff-f59c-4a5f-86b5-9fb70864e3ba 21130-226 HUMAN OTC DRUG Stay Awake Maximum Strength Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 Better Living Brands, LLC CAFFEINE 200 mg/1 N 20181231 21130-230_2ca3a112-bf49-4618-a77c-cc6cb1da8668 21130-230 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130430 OTC MONOGRAPH FINAL part341 Safeway, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 21130-235_91e8e027-e9e6-44fc-ae36-079e3e2a0901 21130-235 HUMAN OTC DRUG Extra Strength Pain Relief PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 20181110 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 21130-236_220cca57-2d96-4a7a-b77d-e102ffe7c329 21130-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 Safeway, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 21130-238_e782953c-d0d9-4040-88b9-1ecc94bab6ef 21130-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 Safeway, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 21130-240_a213c774-4879-46ec-8ebc-c6e7283df139 21130-240 HUMAN OTC DRUG FOAMING HAND SANITIZER WITH ALOE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333 SAFEWAY INC BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 21130-242_e5ef1045-83a2-457b-ba52-128075052206 21130-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH FINAL part347 Safeway, Inc. DIMETHICONE 125 mg/1 N 20181231 21130-243_752980bd-4d93-4478-9477-840a765e3d33 21130-243 HUMAN OTC DRUG signature care childrens pain relief Acetaminophen SUSPENSION ORAL 20150928 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 160 mg/5mL N 20181231 21130-247_da7cfa1d-d1f6-48de-9947-c5250d37d8ef 21130-247 HUMAN OTC DRUG Advanced Healing Petrolatum OINTMENT TOPICAL 20150715 OTC MONOGRAPH FINAL part347 Better Living Brands LLC PETROLATUM 340 mg/g N 20181231 21130-248_d6095993-90fc-4a45-8f8f-a924c89ffbe2 21130-248 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090105 OTC MONOGRAPH FINAL part341 Safeway CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 48; 12; 26 mg/g; mg/g; mg/g N 20181231 21130-249_adbf2c58-cd1c-4444-b133-21a18a348931 21130-249 HUMAN OTC DRUG signature care acid controller Famotidine TABLET ORAL 20150904 ANDA ANDA075400 Safeway FAMOTIDINE 10 mg/1 N 20181231 21130-252_276fb7c1-a445-4982-e054-00144ff8d46c 21130-252 HUMAN OTC DRUG Safeway Instant Hand Sanitizing wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Safeway Inc. ALCOHOL .659 mL/mL N 20181231 21130-253_4fd3cfd3-f150-4fce-bec2-52b3367232d1 21130-253 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100202 OTC MONOGRAPH NOT FINAL part333 SAFEWAY INC ALCOHOL 65 mL/100mL N 20181231 21130-254_33300d27-ca28-4c1f-892a-5c2cafea6a4b 21130-254 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 SAFEWAY INC ALCOHOL 65 mL/100mL N 20181231 21130-255_81f1502c-9f9d-4d0a-892d-bed0afcb9d2e 21130-255 HUMAN OTC DRUG SAFEWAY ETHYL ALCOHOL LIQUID TOPICAL 20111213 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC ALCOHOL 65 mL/100mL N 20181231 21130-264_bb842e61-371b-496e-b36e-e718461c0bb6 21130-264 HUMAN OTC DRUG Sinus and Allergy Relief Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 21130-265_4a4f7f82-1b6d-7082-e054-00144ff88e88 21130-265 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20140522 OTC MONOGRAPH FINAL part341 Safeway Inc. MENTHOL 5.4 mg/1 N 20181231 21130-266_4a52c0c2-865a-2819-e054-00144ff8d46c 21130-266 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20140522 OTC MONOGRAPH FINAL part341 Safeway Inc. MENTHOL 5.8 mg/1 N 20181231 21130-267_4a9e4c8b-a2c8-71e5-e054-00144ff8d46c 21130-267 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20140522 OTC MONOGRAPH FINAL part341 SafeWayInc. MENTHOL 7.5 mg/1 N 20181231 21130-268_4a9ed913-1afa-187d-e054-00144ff8d46c 21130-268 HUMAN OTC DRUG SF Menthol Cough Drop Menthol LOZENGE ORAL 20140522 OTC MONOGRAPH FINAL part341 Safeway Inc. MENTHOL 5.8 mg/1 N 20181231 21130-270_1d31340b-beec-44bb-e054-00144ff8d46c 21130-270 HUMAN OTC DRUG Pain Relief Rapid Release Gelcaps Extra Strength Acetaminophen TABLET, COATED ORAL 20150805 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 500 mg/1 N 20181231 21130-273_16f7c593-5e1e-4248-9e62-b6db1eb8ae6f 21130-273 HUMAN OTC DRUG signature care hair regrowth treatment Minoxidil SOLUTION TOPICAL 20150904 ANDA ANDA075598 Safeway MINOXIDIL 3 g/60mL N 20181231 21130-274_50d3fab5-36e6-46a8-e054-00144ff8d46c 21130-274 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20170530 OTC MONOGRAPH FINAL part341 Better Living Brands LLC MENTHOL 5.4 mg/1 N 20181231 21130-275_50c360d3-7681-2b5c-e054-00144ff8d46c 21130-275 HUMAN OTC DRUG Cherry Cough Drop menthol LOZENGE ORAL 20170530 OTC MONOGRAPH FINAL part341 Better Living Brands LLC MENTHOL 5.8 mg/1 N 20181231 21130-276_50c29413-ef94-100d-e054-00144ff88e88 21130-276 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20170530 OTC MONOGRAPH FINAL part341 Better Living Brands LLC MENTHOL 7.5 mg/1 N 20181231 21130-277_50d668d6-8ea3-710b-e054-00144ff88e88 21130-277 HUMAN OTC DRUG SF Menthol Cough Drops Menthol LOZENGE ORAL 20170530 OTC MONOGRAPH FINAL part341 Better Living Brands LLC MENTHOL 5.8 mg/1 N 20181231 21130-278_ed0eb068-3ce6-423d-a7f8-c3456b7f6040 21130-278 HUMAN OTC DRUG Signature Care Anti Itch Hydrocortisone CREAM TOPICAL 20151014 OTC MONOGRAPH NOT FINAL part348 Safeway HYDROCORTISONE 1 g/100g N 20181231 21130-281_48ff5b35-c8e9-4815-8524-c5d4025ed8fb 21130-281 HUMAN OTC DRUG Pain Reliever Childrens Acetaminophen SUSPENSION ORAL 20150630 OTC MONOGRAPH NOT FINAL part343 Safeway, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 21130-283_01dd5109-5d0c-41cf-9bc5-e3c45ac4e400 21130-283 HUMAN OTC DRUG Signature Care Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, FILM COATED ORAL 20150901 ANDA ANDA079113 Safeway DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 21130-285_6bcb8e66-72a0-47a1-8913-f8886730383f 21130-285 HUMAN OTC DRUG Dye Free Pain Reliever Childrens Acetaminophen SUSPENSION ORAL 20150630 OTC MONOGRAPH NOT FINAL part343 Safeway, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 21130-287_e22ebf7c-25e3-4bbf-a856-38f3c38bd393 21130-287 HUMAN OTC DRUG Signature Care Athletes Foot Clotrimazole CREAM TOPICAL 20151016 OTC MONOGRAPH FINAL part333C Safeway CLOTRIMAZOLE 1 g/100g N 20181231 21130-291_9c9e7efb-322c-4212-a790-6032fd18e0f3 21130-291 HUMAN OTC DRUG anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 20070730 UNAPPROVED DRUG OTHER Safeway DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 21130-292_305196c7-1d56-4a02-8770-54015b2d1b76 21130-292 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 20190912 ANDA ANDA075010 Better Living Brands, LLC IBUPROFEN 200 mg/1 N 20181231 21130-294_fbcce930-35ca-4feb-85f5-60986137ccf3 21130-294 HUMAN OTC DRUG SAFEWAY TRICLOSAN LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC. TRICLOSAN .15 mL/100mL N 20181231 21130-296_798df820-1e10-440a-80b1-a491140527f1 21130-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 19981208 OTC MONOGRAPH FINAL part358H Safeway, Inc PYRITHIONE ZINC 14 mg/mL N 20181231 21130-298_7aa90961-39ea-490e-8fc9-541c8ae5d684 21130-298 HUMAN OTC DRUG Vegetable Laxative Sennosides TABLET ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 Better Living Brands, LLC SENNOSIDES 8.6 mg/1 N 20181231 21130-299_dee94394-58da-41fd-967e-47c464e705d8 21130-299 HUMAN OTC DRUG Mint Cetylpyridinium Chloride MOUTHWASH ORAL 20090529 OTC MONOGRAPH NOT FINAL part356 Safeway, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 21130-304_0e0eb1e3-35e4-4211-a10f-1e1f3c31e82c 21130-304 HUMAN OTC DRUG Nasal Decongestant oxymetazoline hydrochloride SPRAY NASAL 20140305 OTC MONOGRAPH FINAL part341 Safeway OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 21130-311_19ce3315-9b44-45d8-9f6f-4b45cf2cb39d 21130-311 HUMAN OTC DRUG Daytime Cold and Flu Relief Non Drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 21130-312_0076888f-1a00-4986-ae90-13943c8d8eb9 21130-312 HUMAN OTC DRUG childrens cold and allergy relief Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/10mL; mg/10mL N 20181231 21130-318_92a93bff-af61-4107-a13b-be98e15ed926 21130-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19900715 OTC MONOGRAPH NOT FINAL part356 Safeway Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 21130-320_27982fb4-6a8d-4fb4-952b-bbc00e923370 21130-320 HUMAN OTC DRUG SAFEWAY DIMETHICONE LOTION TOPICAL 20120103 OTC MONOGRAPH FINAL part347 SAFEWAY INC. DIMETHICONE 1.25 mL/100mL N 20181231 21130-322_95d3272f-ce49-4aac-8325-1e6b75da05b0 21130-322 HUMAN OTC DRUG Pain and Fever Relief Infants Acetaminophen SUSPENSION ORAL 20150630 OTC MONOGRAPH NOT FINAL part343 Safeway, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 21130-323_cd3f1023-8a0c-4ab8-9099-759ef218b529 21130-323 HUMAN OTC DRUG Pain Relief Dye Free Infants Acetaminophen SUSPENSION ORAL 20150630 OTC MONOGRAPH NOT FINAL part343 Safeway, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 21130-326_5360fe23-4ed1-4b82-802b-8daa5f8a482a 21130-326 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20050212 20181214 OTC MONOGRAPH NOT FINAL part334 Better Living Brands, LLC BISACODYL 5 mg/1 E 20171231 21130-327_16e62a24-3f36-432c-bf8c-5a2c9a8a86d0 21130-327 HUMAN OTC DRUG Laxative Bisacodyl TABLET, SUGAR COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Better Living Brands, LLC BISACODYL 5 mg/1 N 20191231 21130-329_bdfcbc01-0b4b-4b1f-b3e6-3d61d23e476e 21130-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 21130-330_327e6873-ba0d-4021-9adc-b356e2b5b538 21130-330 HUMAN OTC DRUG SAFEWAY PETROLATUM JELLY TOPICAL 20120103 OTC MONOGRAPH FINAL part346 SAFEWAY INC. PETROLATUM 41 g/100g N 20181231 21130-336_106ff398-7ae3-4eae-bd7d-a8ac2e0254fd 21130-336 HUMAN OTC DRUG Arthritis 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Safeway Inc. ACETAMINOPHEN 650 mg/1 N 20181231 21130-338_1bf50421-699b-4276-a646-d66b32afec40 21130-338 HUMAN OTC DRUG DM Max Relief Maximum Strength dextromethorphan hydrobromide, guaifenesin LIQUID ORAL 20140731 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 21130-339_057d917a-d5fb-4c6f-bf85-181235a9e6dd 21130-339 HUMAN OTC DRUG Signature Care Cool Heat Menthol, Methyl salicylate CREAM TOPICAL 20151202 OTC MONOGRAPH NOT FINAL part348 Safeway MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 21130-341_2fbe67b0-c961-4599-b543-f966eeee1edc 21130-341 HUMAN OTC DRUG signature care athletes foot Miconazole Nitrate SPRAY TOPICAL 20151009 OTC MONOGRAPH FINAL part333C Safeway MICONAZOLE NITRATE 2 g/100g N 20181231 21130-343_f84ee889-1848-4d97-940b-30ee07ed24d0 21130-343 HUMAN OTC DRUG Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 21130-345_d9511b28-141e-427b-aefd-ccbec0eb35e6 21130-345 HUMAN OTC DRUG Night Time Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 21130-346_b1d4e680-4191-4284-bb56-f8f863f060d9 21130-346 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate TABLET ORAL 20110506 OTC MONOGRAPH FINAL part335 Better Living Brands, LLC BISMUTH SUBSALICYLATE 262 mg/1 N 20191231 21130-348_226d4b10-bf11-468d-bdf2-19616903d9e6 21130-348 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET ORAL 20030102 OTC MONOGRAPH NOT FINAL part334 Better Living Brands, LLC SENNOSIDES 25 mg/1 N 20181231 21130-355_cf216669-224a-4177-8a06-e075e742c0ad 21130-355 HUMAN OTC DRUG Sinus Relief Daytime Acetaminophen, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070822 20181111 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 E 20171231 21130-360_69c1ffc5-162e-4446-9947-af01e9ebd04e 21130-360 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20150531 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 21130-363_92cd98c8-db0b-4add-a894-521761e08326 21130-363 HUMAN OTC DRUG signature care infants ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20150928 ANDA ANDA075217 Safeway IBUPROFEN 50 mg/1.25mL N 20181231 21130-367_a74bf5b9-65cd-4ab4-ab4e-de7ac2e6aaf9 21130-367 HUMAN OTC DRUG Nighttime Sleep Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 20180603 OTC MONOGRAPH FINAL part338 Safeway DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 21130-369_b302145c-11b5-4b1b-bffe-f5c611f482e5 21130-369 HUMAN OTC DRUG Signature Care Hydrocortisone Hydrocortisone CREAM TOPICAL 20151111 OTC MONOGRAPH NOT FINAL part348 Safeway HYDROCORTISONE 1 g/100g N 20181231 21130-370_9c3b982e-ec78-4328-9dca-f902ab84e1b3 21130-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20140906 OTC MONOGRAPH NOT FINAL part333A Safeway Inc. ALCOHOL 700 mg/mL N 20181231 21130-371_82de061a-e1d5-4cbf-81e8-ee346bd7d1e9 21130-371 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part335 Safeway, Inc. BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 21130-372_a32d0678-c188-459f-96f4-2386e5c6d785 21130-372 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part335 Safeway, Inc. BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 21130-373_814d54ec-26f8-45bd-8607-f159d08555da 21130-373 HUMAN OTC DRUG Pain Relief PM Acetaminophen and Diphenhydramine Citrate TABLET, FILM COATED ORAL 20040607 20190808 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 E 20171231 21130-375_aadd07ac-5535-4c96-91b7-d48bfb927327 21130-375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 Better Living Brands, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 21130-376_c813b5b1-768e-4ae3-88fd-cad15a09aaf5 21130-376 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20141130 OTC MONOGRAPH NOT FINAL part356 Safeway, Inc. PHENOL 1.4 g/100mL N 20181231 21130-378_c92fc98a-228e-46f9-8c82-21502663269f 21130-378 HUMAN OTC DRUG Triacting Daytime Cold Cough Childrens Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20150531 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 21130-379_3762c2bd-ed10-474e-be03-10e8b7361aac 21130-379 HUMAN OTC DRUG Childrens Cold and Cough Nighttime Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20151231 OTC MONOGRAPH FINAL part341 Safeway, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 21130-382_b7e598f0-82d6-4b03-b3ef-5d7f73ec6723 21130-382 HUMAN OTC DRUG Multi Symptom Cold Relief CF Non Drowsy Dextromethorphan HBr, Guaifenesin, Phenylephrine LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 21130-383_125df586-bc4c-4f42-a5e2-b58f89613978 21130-383 HUMAN OTC DRUG Adult Cough Relief DM Dextromethorphan HBr LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL N 20181231 21130-384_34c7f7ec-969a-4ce4-a5b7-f1cf433ff32f 21130-384 HUMAN OTC DRUG cough dm dextromethorphan polistirex SUSPENSION ORAL 20120828 ANDA ANDA091135 Safeway DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 21130-385_6101fbf3-dc23-4452-bbd2-394dc064ddc5 21130-385 HUMAN OTC DRUG Adult Cough and Chest Congestion Relief DM Non Drowsy Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 21130-386_7c58bdec-d042-48f8-b880-1adb2a374ee7 21130-386 HUMAN OTC DRUG Nighttime Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 Better Living Brands, LLC DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 21130-392_2ee035d5-6bc3-46a1-bef7-37cf904012b5 21130-392 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020330 ANDA ANDA075139 Better Living Brands, LLC IBUPROFEN 200 mg/1 N 20181231 21130-393_0c4bcc27-0995-46f6-87ce-90a7e8a07bd4 21130-393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Better Living Brands, LLC IBUPROFEN 200 mg/1 N 20181231 21130-395_beefab66-b056-4bf1-b047-0780704ab87e 21130-395 HUMAN OTC DRUG Signature Care Hydrocortisone Hydrocortisone CREAM TOPICAL 20151024 OTC MONOGRAPH NOT FINAL part348 Safeway HYDROCORTISONE 1 g/100g N 20181231 21130-397_25644ccd-9811-43da-b940-a12783df862a 21130-397 HUMAN OTC DRUG Aspirin Low Dose Chewable Aspirin TABLET, CHEWABLE ORAL 20010904 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ASPIRIN 81 mg/1 N 20181231 21130-398_145d7abe-baa9-71f2-8d2a-4fbf965e3e9a 21130-398 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20160201 ANDA ANDA078878 Albertsons Companies OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 21130-404_4387adce-20bf-fcdb-62b2-bb17673cf324 21130-404 HUMAN OTC DRUG Acid Reducer 150 Ranitidine Hydrochloride Tablets 150mg TABLET, COATED ORAL 20120514 ANDA ANDA078192 Safeway Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 21130-407_e1968592-9231-4ff6-a645-199903f582d1 21130-407 HUMAN OTC DRUG Safeway Cold Sore Treatment Camphor CREAM TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part348 Safeway BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 21130-409_f90e4e4e-2fc0-4abb-b269-0b028f5e18ff 21130-409 HUMAN OTC DRUG Signature Care Triple Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20151014 OTC MONOGRAPH FINAL part333B Safeway BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 21130-411_48c9bbe9-5d31-4b58-ac96-7594fc49431f 21130-411 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr TABLET, SUGAR COATED ORAL 20030503 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 21130-412_dfed9355-9be3-4ae0-8426-a924519c2648 21130-412 HUMAN OTC DRUG SAFEWAY DANDRUFF CLASSIC CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20120103 OTC MONOGRAPH FINAL part358H SAFEWAY INC. PYRITHIONE ZINC 1 mL/100mL N 20181231 21130-413_7e54aa57-44b5-4701-82d1-177aba49a3c1 21130-413 HUMAN OTC DRUG SAFEWAY DANDRUFF CLASSIC CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20120413 OTC MONOGRAPH FINAL part358H SAFEWAY INC. PYRITHIONE ZINC 1 mL/100mL N 20181231 21130-414_3daa78d7-f271-48da-8d46-eb3447779fe6 21130-414 HUMAN OTC DRUG Adult Low Strength Aspirin Aspirin TABLET, COATED ORAL 20040114 20180527 OTC MONOGRAPH NOT FINAL part343 Safeway ASPIRIN 81 mg/1 E 20171231 21130-415_5bc78bff-931d-4221-b3af-727e44bc0e59 21130-415 HUMAN OTC DRUG SAFEWAY DANDRUFF PYRITHIONE ZINC LIQUID TOPICAL 20120413 OTC MONOGRAPH FINAL part358H SAFEWAY INC. PYRITHIONE ZINC 1 mL/100mL N 20181231 21130-415_d4adacf4-95b1-4955-9034-82588b195dcf 21130-415 HUMAN OTC DRUG SAFEWAY DANDRUFF PYRITHIONE ZINC LIQUID TOPICAL 20120103 OTC MONOGRAPH FINAL part358H SAFEWAY INC. PYRITHIONE ZINC 1 mL/100mL N 20181231 21130-416_db7d8507-aa48-4ba5-b14a-a907b07c71bc 21130-416 HUMAN OTC DRUG SAFEWAY DANDRUFF DRY SCALP PYRITHIONE ZINC SHAMPOO TOPICAL 20120528 OTC MONOGRAPH FINAL part358H SAFEWAY INC. PYRITHIONE ZINC 1 mL/100mL N 20181231 21130-419_39c0d610-3d9b-48db-9228-488a5268fd38 21130-419 HUMAN OTC DRUG DayTime NightTime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140630 OTC MONOGRAPH FINAL part341 Safeway, Inc. N 20181231 21130-423_4b53d5f0-b910-4280-8034-ac1c95a9dd65 21130-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Safeway Inc. IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 21130-424_c9154821-606d-4c5d-b361-c3b90d42500c 21130-424 HUMAN OTC DRUG SAFEWAY CARE NORMAL TO OILY HAIR PYRITHIONE ZINC LIQUID TOPICAL 20131120 OTC MONOGRAPH FINAL part358H SAFEWAY INC PYRITHIONE ZINC 10 mg/mL N 20181231 21130-426_2d3cb2d4-3a80-4c5c-b205-ee69b277283a 21130-426 HUMAN OTC DRUG SAFEYWAY CARE NORMAL TO OILY HAIR PYRITHIONE ZINC LIQUID TOPICAL 20131126 OTC MONOGRAPH FINAL part358H SAFEWAY INC PYRITHIONE ZINC 10 mg/mL N 20181231 21130-427_2ce24652-a9b2-4f29-8738-d57233e7282e 21130-427 HUMAN OTC DRUG SAFEWAY CARE DANDRUFF PYRITHIONE ZINC LIQUID TOPICAL 20131213 OTC MONOGRAPH FINAL part358H SAFEWAY INC PYRITHIONE ZINC 10 mg/mL N 20181231 21130-429_66b392d7-a781-469d-bf51-d8df87a3627f 21130-429 HUMAN OTC DRUG Signature Care Nasal Decongestant Oxymetazoline Hydrochloride SPRAY NASAL 20150811 OTC MONOGRAPH FINAL part341 Safeway OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 21130-439_01b13e83-6579-425a-9e5f-adcd92a198c7 21130-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140910 OTC MONOGRAPH NOT FINAL part333A Safeway Inc. ALCOHOL 700 mg/mL N 20181231 21130-443_9de55b27-e685-4540-bc13-5a64f8f953dc 21130-443 HUMAN OTC DRUG Signature Care Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20161107 ANDA ANDA078104 Safeway TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 21130-444_a970d373-c0e1-4d56-8379-6bb3a009ac76 21130-444 HUMAN OTC DRUG Signature Care Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 20150904 ANDA ANDA074661 Safeway NAPROXEN SODIUM 220 mg/1 N 20181231 21130-447_9f50bceb-cf4d-49be-baad-829e89e5410d 21130-447 HUMAN OTC DRUG Childrens Aspirin Free Rapid Tabs Acetaminophen TABLET, CHEWABLE ORAL 20050203 20180817 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN 80 mg/1 E 20171231 21130-448_8d5bac6b-98b6-4fc4-983a-ca5292b4c361 21130-448 HUMAN OTC DRUG Signature Care Triple Antibiotic Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20150927 OTC MONOGRAPH FINAL part333B Safeway BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 21130-450_4d2caad6-a7fc-4683-9b0f-06a976790bf1 21130-450 HUMAN OTC DRUG Junior Aspirin Free Rapid Tabs Acetaminophen TABLET, CHEWABLE ORAL 20050225 20180622 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN 160 mg/1 E 20171231 21130-453_ddf4a725-af38-40c9-bc45-207a0336ecbe 21130-453 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 21130-461_48ddd3d8-98bf-444f-b063-275269ce30af 21130-461 HUMAN OTC DRUG FRESH DECOR BASIL GREEN TEA ETHYL ALCOHOL LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC. ALCOHOL 65 mL/100mL N 20181231 21130-462_0e4ef402-2a7c-4af8-81bd-1870958e22f6 21130-462 HUMAN OTC DRUG FRESH DECOR LEMON VERBENA ETHYL ALCOHOL LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC. ALCOHOL 65 mL/100mL N 20181231 21130-463_3ae9b53a-ea2d-4e26-b2d5-231e04f6f9f5 21130-463 HUMAN OTC DRUG FRESH DECOR CITRUS POMEGRANATE ETHYL ALCOHOL LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC. ALCOHOL 65 mL/100mL N 20181231 21130-464_80492ca8-7d73-47ed-95df-d9ddfb3244cf 21130-464 HUMAN OTC DRUG FRESH DECOR COCONUT CREAM ETHYL ALCOHOL LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part333E SAFEWAY INC. ALCOHOL 65 mL/100mL N 20181231 21130-466_4bf320b8-d660-4c9a-acf9-1f5b65453d13 21130-466 HUMAN OTC DRUG Pain Relief Non Drowsy Daytime Acetaminophen, Phenylephrine HCl TABLET ORAL 20050726 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 21130-468_cd81176f-e12d-486e-9eca-83414cef8f51 21130-468 HUMAN OTC DRUG Day time cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20150531 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 21130-469_326953af-b005-46a9-a095-fc046269ef86 21130-469 HUMAN OTC DRUG Upset Stomach Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20150808 OTC MONOGRAPH FINAL part335 Safeway BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 21130-471_eb43120d-f346-4dbd-a526-6d27ccb5b53b 21130-471 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130715 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 21130-472_60f1fdff-c294-47b8-a67f-211f5cd8b3e3 21130-472 HUMAN OTC DRUG Antacid Relief Calcium carbonate TABLET, CHEWABLE ORAL 20151111 OTC MONOGRAPH FINAL part331 Safeway CALCIUM CARBONATE 1000 mg/1 N 20181231 21130-475_b7e7d503-94dd-469a-925f-62ebc16066f7 21130-475 HUMAN OTC DRUG Signature Care Childrens Allergy Relief Cetirizine HCl SOLUTION ORAL 20150928 ANDA ANDA204226 Safeway CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 21130-480_d36770ed-9370-46a8-bae6-20bc2c95ce00 21130-480 HUMAN OTC DRUG Safeway Nighttime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20121129 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 21130-484_acfc3c56-5272-4384-a3ac-8fdd1cf01cab 21130-484 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 20000706 OTC MONOGRAPH NOT FINAL part343 Safeway ACETAMINOPHEN 500 mg/1 N 20181231 21130-485_b1681610-0894-426f-80ea-82a6f85b5933 21130-485 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 Safeway, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 21130-486_d906429f-15b9-462c-8339-b7de408162bd 21130-486 HUMAN OTC DRUG stool softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20050727 OTC MONOGRAPH NOT FINAL part334 Safeway DOCUSATE SODIUM 100 mg/1 N 20181231 21130-490_87498b9e-42ed-492f-9efc-22c38c3248d8 21130-490 HUMAN OTC DRUG Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130715 OTC MONOGRAPH FINAL part341 Safeway, Inc. N 20181231 21130-502_951e0726-5ca5-4a23-ba08-3891231e844c 21130-502 HUMAN OTC DRUG Sinus Relief MAXIMUM STRENGTH Acetaminophen, Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 21130-503_9fe22ba5-7077-4182-99f3-8ae7a2751443 21130-503 HUMAN OTC DRUG Aspirin Free Cold Head Congestion Day Time Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 20190126 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 21130-505_ae7adfa3-45f5-45ad-ad9b-31d1af887a4e 21130-505 HUMAN OTC DRUG Mucus Relief DM Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20160630 OTC MONOGRAPH FINAL part341 Safeway, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 21130-507_6bb5a659-1588-4d0c-ad0a-588aec8c8714 21130-507 HUMAN OTC DRUG signature care pain relief Naproxen sodium TABLET, FILM COATED ORAL 20150929 ANDA ANDA074661 Safeway NAPROXEN SODIUM 220 mg/1 N 20181231 21130-508_ac703a32-8e0f-4dd4-b7b8-5fba72b7cd59 21130-508 HUMAN OTC DRUG Antacid Aluminum Hydroxide, Magnesium Hydroxide and Simethicone SUSPENSION ORAL 20151212 OTC MONOGRAPH FINAL part332 Safeway ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 21130-514_83d25395-9244-4c3f-b084-4d6bb85c24c5 21130-514 HUMAN OTC DRUG signature care antacid plus gas relief aluminum hydroxide, magnesium hydroxide, simethicone SUSPENSION ORAL 20150722 OTC MONOGRAPH FINAL part331 Safeway ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 21130-519_c04f7994-d05f-4223-9183-0ada0a897cd1 21130-519 HUMAN OTC DRUG Extra Strength Aspirin Free Pain Relief Acetaminophen TABLET ORAL 20040510 20180611 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN 500 mg/1 E 20171231 21130-526_75d455cf-14b2-4000-b125-14da7676883d 21130-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20090606 ANDA ANDA076134 SAFEWAY INC. LORATADINE 10 mg/1 N 20181231 21130-527_d5ec9af0-b2a0-47cd-a418-cfc00df2afd8 21130-527 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Safeway Inc. LORATADINE 10 mg/1 N 20181231 21130-529_d6eae395-b048-407a-82c1-7d02aa28f690 21130-529 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 20181015 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC E 20171231 21130-530_ac50bbbc-f6de-45a3-94fa-4b2c48956452 21130-530 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20151231 OTC MONOGRAPH FINAL part332 Safeway, Inc. DIMETHICONE 180 mg/1 N 20181231 21130-533_d7778fc3-67de-41c4-9bc9-5b7d2d50d8c0 21130-533 HUMAN OTC DRUG IMMEDIATE-RELEASE MUCUS RELIEF DM Dextromethorphan HBr, Guaifenesin TABLET, FILM COATED ORAL 20051231 20181110 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 E 20171231 21130-540_8e0257bd-6b19-4a7c-acdf-bf8248c54f7f 21130-540 HUMAN OTC DRUG Pain Relief Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN 160 mg/1 N 20181231 21130-541_437da8bc-b6bd-46ca-bc72-728ecfc6f79e 21130-541 HUMAN OTC DRUG Anti Itch Hydrocortisone CREAM TOPICAL 20050824 OTC MONOGRAPH NOT FINAL part348 Safeway HYDROCORTISONE 1 g/100g N 20181231 21130-542_e6263109-5b5f-4ca1-80be-05dd074e556e 21130-542 HUMAN OTC DRUG Mucus Relief PE Guaifenesin and Phenylephrine HCl TABLET, FILM COATED ORAL 20060415 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 21130-556_1d4414c2-74c8-46da-bd71-6c81f10af6d7 21130-556 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 21130-557_dfda3c7c-4c57-5917-ab77-7b5372ec14d2 21130-557 HUMAN OTC DRUG Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE ORAL 20130205 ANDA ANDA079043 Safeway Inc FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 N 20181231 21130-559_7b064f76-5677-4003-8e52-b5967eff93d5 21130-559 HUMAN OTC DRUG Signature Care First Aid Antibiotic Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20151110 OTC MONOGRAPH FINAL part333B Safeway NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g N 20181231 21130-560_8d4d1f3b-d257-4b98-bd92-63729cd79278 21130-560 HUMAN OTC DRUG Pain Relief Non-Drowsy, Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20080329 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 21130-568_7c8fb144-3d54-4699-a4fa-9e6a3a6bd3c8 21130-568 HUMAN OTC DRUG signature care acid control Ranitidine TABLET, FILM COATED ORAL 20150901 ANDA ANDA091429 Safeway RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 21130-569_6a5a5d85-0c29-4991-a40e-f894a9ddfc2f 21130-569 HUMAN OTC DRUG Signature Care Migraine Relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20150901 ANDA ANDA075794 Safeway ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 21130-575_4d0ba41c-ddde-494b-a318-66ce276c377f 21130-575 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part333A Better Living Brands LLC BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 21130-577_865a0772-ceca-4221-aaf1-7f457c2ea9e0 21130-577 HUMAN OTC DRUG signature care hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20151120 OTC MONOGRAPH FINAL part346 Safeway MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 21130-584_65361fba-e1b7-4ffa-81a2-63aff96bd29c 21130-584 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 Safeway, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 21130-585_29faee73-b682-4458-a4ea-b0042e05560e 21130-585 HUMAN OTC DRUG Signature Care Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20150812 ANDA ANDA072096 Safeway IBUPROFEN 200 mg/1 N 20181231 21130-589_838d2f11-2ee4-4081-98c8-b87e79aa47c4 21130-589 HUMAN OTC DRUG Signature Care Nasal Decongestant oxymetazoline hydrochloride SPRAY NASAL 20150730 OTC MONOGRAPH FINAL part341 Safeway OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 21130-600_108b1547-0d5c-44e0-8688-995bd5d2aa8d 21130-600 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ASPIRIN 81 mg/1 N 20191231 21130-601_406d1f07-7abb-44dd-8105-49bb137c4b56 21130-601 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20140820 NDA NDA021996 Safeway KETOTIFEN FUMARATE .25 mg/mL N 20181231 21130-602_2d10f449-6802-4d44-9965-1423174bee22 21130-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20021112 OTC MONOGRAPH NOT FINAL part334 Safeway Inc MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 21130-604_5a075f32-a49b-40a2-8d3e-7c6d350809ed 21130-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19970814 ANDA ANDA072096 Safeway IBUPROFEN 200 mg/1 N 20181231 21130-606_d94e6e52-9041-4bda-a3d2-c5202e76c23d 21130-606 HUMAN OTC DRUG signature care ibuprofen childrens Ibuprofen SUSPENSION ORAL 20150819 ANDA ANDA074937 Safeway IBUPROFEN 100 mg/5mL N 20181231 21130-610_31e65e9d-35da-4899-91bf-e95e2bd2a8ec 21130-610 HUMAN OTC DRUG ANTIDANDRUFF MEDICATED SELENIUM SULFIDE SHAMPOO TOPICAL 20100805 OTC MONOGRAPH FINAL part358 SAFEWAY INC SELENIUM SULFIDE 1 mL/100mL N 20181231 21130-617_57d116c0-0b01-474e-981c-da18b868d0a4 21130-617 HUMAN OTC DRUG SAFEWAY MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20120604 OTC MONOGRAPH FINAL part358H SAFEWAY INC. SELENIUM SULFIDE 1 mL/100mL N 20181231 21130-619_88cb3c62-7d70-439b-abcd-912c3eadbe75 21130-619 HUMAN OTC DRUG SAFEWAY CARE MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20140225 OTC MONOGRAPH FINAL part358H SAFEWAY INC SELENIUM SULFIDE 10 mg/mL N 20181231 21130-620_a4a72e34-da4e-4ac9-9a86-20fc3092b183 21130-620 HUMAN OTC DRUG SAFEWAY SELENIUM SULFIDE LIQUID TOPICAL 20130620 OTC MONOGRAPH FINAL part358H SAFEWAY INC. SELENIUM SULFIDE 10 mg/mL N 20181231 21130-628_18c2a238-ed79-4aba-a285-bb2a004dd962 21130-628 HUMAN OTC DRUG Signature Care Hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20151103 OTC MONOGRAPH FINAL part346 Safeway COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 21130-635_af041f47-3320-41a7-87f7-0f1152f3bf43 21130-635 HUMAN OTC DRUG Signature Care Daytime Cough Dextromethorphan HBr SOLUTION ORAL 20150928 OTC MONOGRAPH FINAL part341 Safeway DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL N 20181231 21130-645_5b48fa5a-47b5-4bfc-ae71-3a11e8df72c4 21130-645 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ASPIRIN 81 mg/1 N 20181231 21130-651_54006210-e6ae-44b5-90bf-c75052ea53f5 21130-651 HUMAN OTC DRUG Signature Care Athletes foot tolnaftate SPRAY TOPICAL 20151123 OTC MONOGRAPH FINAL part333C Safeway TOLNAFTATE 1 g/100g N 20181231 21130-655_d5dbe95f-5037-4580-8a68-41b0059597f5 21130-655 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH NOT FINAL part334 Better Living Brands, LLC DOCUSATE SODIUM 100 mg/1 N 20191231 21130-663_fddebd0a-4716-4cff-bb60-0ba8773a0a49 21130-663 HUMAN OTC DRUG Sinus Relief Non-Drowsy Daytime Acetaminophen, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 21130-664_73596150-2a89-4862-b41c-f126d70fead8 21130-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19980315 OTC MONOGRAPH NOT FINAL part356 Better Living Brands LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 21130-667_e3a999cf-86a9-471e-a39f-5df87c768c7d 21130-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20030206 OTC MONOGRAPH NOT FINAL part334 Better Living Brands LLC MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 21130-676_26089dff-8b80-4bb1-89d6-b229c13f7e51 21130-676 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 Better Living Brands, LLC BISACODYL 5 mg/1 N 20181231 21130-680_c2689a86-ce79-de80-9a67-db4c229d7d4c 21130-680 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160815 ANDA ANDA208150 Safeway FLUTICASONE PROPIONATE 50 ug/1 N 20181231 21130-689_467c0dba-be05-4912-8fe6-1b249fbd4c8a 21130-689 HUMAN OTC DRUG Cough and Cold HBP chlorpheniramine maleate, dextromethorphan HBr TABLET ORAL 20170331 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 21130-693_031f7f4c-3aa1-44ae-90a8-9cfd40c7bde8 21130-693 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate SOLUTION ORAL 20151120 OTC MONOGRAPH NOT FINAL part334 Better Living Brands LLC MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 21130-694_15315b52-7296-499c-9379-a8ee43ec14e4 21130-694 HUMAN OTC DRUG signature care anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20150901 UNAPPROVED DRUG OTHER Safeway DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 21130-710_ec0274a7-ae36-295b-7139-717483111c4c 21130-710 HUMAN OTC DRUG Budesonide Budesonide SPRAY, METERED NASAL 20160915 ANDA ANDA078949 Safeway BUDESONIDE 32 ug/1 N 20181231 21130-724_2c559299-a50b-46ce-818c-cf99d9edb61c 21130-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Safeway Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 21130-750_9822f801-4198-476f-b9dc-57eda42a06fb 21130-750 HUMAN OTC DRUG Signature Care Hair Regrowth Treatment for men Minoxidil AEROSOL, FOAM TOPICAL 20150904 ANDA ANDA091344 Safeway MINOXIDIL 5 g/100g N 20181231 21130-757_38fc0c5c-e0bc-44d2-acbd-d4d329fef1e1 21130-757 HUMAN OTC DRUG signature care first aid antibiotic Bacitracin OINTMENT TOPICAL 20150914 OTC MONOGRAPH FINAL part333B Safeway BACITRACIN 500 [USP'U]/g N 20181231 21130-760_0a02ebb4-0d21-4159-b143-54662c512451 21130-760 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Safeway Inc. ACETAMINOPHEN 650 mg/1 N 20181231 21130-763_87212bb7-6690-48d9-90e2-9f6dab1da777 21130-763 HUMAN OTC DRUG Sleep Aid Nighttime Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Better Living Brands, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 21130-766_8c6f2602-df1e-47c7-af39-e19c6934d076 21130-766 HUMAN OTC DRUG Sinus Headache PE Maximum Strength Acetaminophen and Phenylephrine HCl TABLET ORAL 20050623 20180623 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 E 20171231 21130-768_aab32069-da55-4b32-9cc9-d20997985083 21130-768 HUMAN OTC DRUG Daytime Cold and Pain Relief Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 20190126 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 21130-777_7dd706f2-d080-460a-93bc-6bccba815551 21130-777 HUMAN OTC DRUG Signature Care Acid Controller maximum strength Famotidine TABLET ORAL 20150904 ANDA ANDA077351 Safeway FAMOTIDINE 20 mg/1 N 20181231 21130-778_10e87a7b-7b1d-4ed3-962e-f6ebc1f3b54c 21130-778 HUMAN OTC DRUG Motion Sickness Relief Less Drowsy Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 Better Living Brands, LLC MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 21130-779_ac71c5e1-ae01-4ef4-bf90-4e68cf5c95b7 21130-779 HUMAN OTC DRUG Pain Relief PM Extra Strength Aspirin Free Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130315 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 21130-784_555a40f9-b701-9f18-3afc-b1c4304e35fa 21130-784 HUMAN OTC DRUG Allergy Relief Fexofenadine hydrochloride TABLET ORAL 20130422 ANDA ANDA076502 Safeway Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 21130-787_b55db1a4-f78b-48aa-8a9d-fce56def3d10 21130-787 HUMAN OTC DRUG Childrens Non-Drowsy 24-Hour Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Safeway Inc. LORATADINE 5 mg/5mL N 20181231 21130-788_273ebb96-8b7f-4fb5-a84f-1336ce6e9727 21130-788 HUMAN OTC DRUG Signature Care Hemorrhoidal Glycerin, Phenylephrine HCI, Pramoxine HCI, and White petrolatum CREAM TOPICAL 20160120 OTC MONOGRAPH FINAL part346 Better Living Brands, LLC GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 144; 2.5; 10; 150 mg/g; mg/g; mg/g; mg/g N 20181231 21130-789_207f78c4-e0b8-4e1f-9864-c34a3d0a7492 21130-789 HUMAN OTC DRUG Signature Care Hemorrhoidal Mineral oil, Petrolatum, and Phenylephrine HCI OINTMENT TOPICAL 20160120 OTC MONOGRAPH FINAL part346 Better Living Brands, LLC PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL; PETROLATUM 2.5; 140; 749 mg/g; mg/g; mg/g N 20181231 21130-795_ecd6833e-7c71-4427-a56a-7905d405c3a4 21130-795 HUMAN OTC DRUG signature care antacid plus gas relief Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20150901 OTC MONOGRAPH FINAL part331 Safeway ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 21130-799_8bbc395c-8a56-4fca-8e5a-974903c3c266 21130-799 HUMAN OTC DRUG Signature Care Tussin Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20150812 OTC MONOGRAPH FINAL part341 Safeway DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 21130-801_23f0a5b3-59ae-4eb3-9b7d-e6a492060337 21130-801 HUMAN OTC DRUG Signature Care Nasal Decongestant Oxymetazoline HCl SPRAY NASAL 20150709 OTC MONOGRAPH FINAL part341 Safeway OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 21130-803_54c554af-f04e-42fb-ae1f-5fa8d571e016 21130-803 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20121112 OTC MONOGRAPH FINAL part347 Lucerne North America LLC LANOLIN; PETROLATUM 133; 459 mg/g; mg/g N 20181231 21130-804_3643813f-97a8-4fea-b3b0-b9ca684c099a 21130-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090513 OTC MONOGRAPH NOT FINAL part333A Better Living Brands LLC ISOPROPYL ALCOHOL .91 mg/mL N 20181231 21130-805_e95ef6dc-f81f-413c-94eb-1c8eb3be3d25 21130-805 HUMAN OTC DRUG Signature Care Antifungal Tolnaftate CREAM TOPICAL 20150826 OTC MONOGRAPH FINAL part333C Better Living Brands LLC TOLNAFTATE 10 mg/g N 20181231 21130-806_0b90f9e2-99a9-4617-82af-d64d97a944d4 21130-806 HUMAN OTC DRUG Signature Care Antifungal Clotrimazole CREAM TOPICAL 20150826 OTC MONOGRAPH FINAL part333C Better Living Brands LLC CLOTRIMAZOLE 10 mg/g N 20181231 21130-810_25f41633-5a3d-49a9-94d1-b77c3ea39caa 21130-810 HUMAN OTC DRUG 70% Isopropyl Rubbing Alcohol Isopropyl Rubbing Alcohol SOLUTION TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part333A Better Living Brands LLC ISOPROPYL ALCOHOL .7 mg/mL N 20181231 21130-817_b5185ed6-8d93-431d-b06f-0476253917d7 21130-817 HUMAN OTC DRUG Severe Congestion and Cough Relief Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20151111 OTC MONOGRAPH FINAL part341 Safeway DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 21130-818_4abeee1b-cdaa-418f-87af-5b56257cc42a 21130-818 HUMAN OTC DRUG Signature Care Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20150914 ANDA ANDA072096 Safeway IBUPROFEN 200 mg/1 N 20191231 21130-822_4bf58414-5313-4f96-b9c2-5c25ed35ba87 21130-822 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20150618 OTC MONOGRAPH FINAL part346 Better Living Brands LLC WITCH HAZEL 979 mg/mL N 20181231 21130-826_886e75dc-00ea-491f-89ed-1c9e5cc13e6a 21130-826 HUMAN OTC DRUG SAFEWAY ACNE TREATMENT BENZOYL PEROXIDE CREAM TOPICAL 20120606 OTC MONOGRAPH NOT FINAL part333D SAFEWAY INC. BENZOYL PEROXIDE 10 g/100g N 20181231 21130-831_76af495a-4f6c-4701-9e2c-4d9c0077b421 21130-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 20021113 OTC MONOGRAPH NOT FINAL part334 Safeway MINERAL OIL 999 mg/mL N 20181231 21130-845_9eb8b873-029c-4457-a10c-e74edccdf593 21130-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20150626 OTC MONOGRAPH FINAL part344 Better Living Brands ISOPROPYL ALCOHOL 613 mg/mL N 20181231 21130-847_35f059d0-e54b-4666-abe4-fdff9aaa5578 21130-847 HUMAN OTC DRUG signature care clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20150901 ANDA ANDA090685 Safeway POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 21130-850_ad119b00-0730-4a54-a092-8035a86b9e44 21130-850 HUMAN OTC DRUG Pain Relief Junior Acetaminophen TABLET, CHEWABLE ORAL 20050225 20211109 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN 160 mg/1 N 20181231 21130-864_0a82224a-d80e-4526-bf76-01f04a1cd5a3 21130-864 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part332 Better Living Brands, LLC DIMETHICONE 125 mg/1 N 20181231 21130-866_7d9b0b4d-0ccc-4376-878c-6c303228d45e 21130-866 HUMAN OTC DRUG Day Time Cold and Flu Relief non drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 21130-868_aa024c7f-aa03-427e-9424-3c86230791a3 21130-868 HUMAN OTC DRUG Cold and Flu DayTime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part341 Safeway, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 21130-871_362f46f3-ccf0-4306-aa36-03bf483f9b22 21130-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20150618 OTC MONOGRAPH NOT FINAL part333A Better Living Brands LLC HYDROGEN PEROXIDE 30 mg/mL N 20181231 21130-877_95904b21-752d-48b4-a882-8d81d2384e1f 21130-877 HUMAN OTC DRUG signature care ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20150914 ANDA ANDA077349 Safeway IBUPROFEN 200 mg/1 N 20181231 21130-898_96152e54-1d86-450c-a036-4d360facc1db 21130-898 HUMAN OTC DRUG Oatmeal Dimethicone LOTION TOPICAL 20160309 OTC MONOGRAPH FINAL part347 Better Living Brands, LLC DIMETHICONE 13 mg/mL N 20181231 21130-904_85810570-3538-4da6-baaa-fc2109aaab63 21130-904 HUMAN OTC DRUG Pain Relief Regular Strength, Aspirin Free Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN 325 mg/1 N 20181231 21130-911_c31455f0-2008-4323-b503-8e8734994826 21130-911 HUMAN OTC DRUG signature care childrens ibuprofen Ibuprofen SUSPENSION ORAL 20150904 ANDA ANDA074937 Safeway IBUPROFEN 100 mg/5mL N 20181231 21130-912_e5c60ed1-29f7-41b4-9a19-a5edbe5ed2a3 21130-912 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20171101 OTC MONOGRAPH FINAL part347 Better Living Brands, LLC LANOLIN; 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GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 21130-918_3beace70-9bc0-467e-89d8-98602709e5ec 21130-918 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ASPIRIN 81 mg/1 N 20181231 21130-919_ce02a386-144c-4074-ab6b-766982fa2b59 21130-919 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN 500 mg/1 N 20181231 21130-921_1a7005f8-44de-488e-b1de-c2805bd8128b 21130-921 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Better Living Brands, LLC IBUPROFEN 200 mg/1 N 20181231 21130-927_b9cf7e86-7a58-41a8-9400-6a602ca817db 21130-927 HUMAN OTC DRUG Sinus PE Pressure, Pain and Mucus Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 21130-928_b213f35a-3bfc-4d2e-bfc1-a5bc1b5e50dd 21130-928 HUMAN OTC DRUG Signature Care Medicated Cooling Witch Hazel CLOTH TOPICAL 20161003 OTC MONOGRAPH FINAL part346 Better Living Brands, LLC WITCH HAZEL 500 mg/1 N 20181231 21130-933_b05776d8-2e27-4c6a-a7fc-8bde789b242a 21130-933 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr TABLET ORAL 20051231 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 21130-941_20d0314f-ae2a-4d41-8ac4-ee7d43b587aa 21130-941 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20150615 OTC MONOGRAPH FINAL part347 Better Living Brands LLC FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 21130-942_937e8f45-b3c7-4eac-b36d-1cdecca898d0 21130-942 HUMAN OTC DRUG 2 in 1 Dandruff Pyrithione zinc SHAMPOO TOPICAL 20061011 OTC MONOGRAPH FINAL part358H Living Better Brands LLC PYRITHIONE ZINC 10 mg/mL N 20181231 21130-944_ffc6ef3a-909b-4907-857c-428b5c42ebbc 21130-944 HUMAN OTC DRUG Awake Maximum Strength Caffeine TABLET, FILM COATED ORAL 19980414 OTC MONOGRAPH FINAL part340 Better Living Brands, LLC CAFFEINE 200 mg/1 N 20181231 21130-952_77ddd753-0982-48ef-a358-6522b01aa322 21130-952 HUMAN OTC DRUG Clear Anti Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 20090428 OTC MONOGRAPH FINAL part347 Better Living Brands LLC PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 21130-955_bd4b8715-71d4-4f14-a1f1-f6c465c57034 21130-955 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, FILM COATED ORAL 20051222 OTC MONOGRAPH FINAL part341 Better Living Brands, LLC GUAIFENESIN 400 mg/1 N 20181231 21130-957_7a6c1ef6-f25b-4250-a7aa-f925f70ff348 21130-957 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ASPIRIN 325 mg/1 N 20181231 21130-959_4fa2792c-e3af-4e79-8475-b616ae21ac79 21130-959 HUMAN OTC DRUG Pain Relief Added Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 21130-971_5f458e1c-0c7c-4521-8b1c-a78e0800755b 21130-971 HUMAN OTC DRUG Ultra Strength Antacid Relief Assorted Berry Calcium carbonate TABLET, CHEWABLE ORAL 20150808 OTC MONOGRAPH FINAL part331 Safeway CALCIUM CARBONATE 1000 mg/1 N 20181231 21130-975_555282b1-6d47-455f-96b1-81200881e942 21130-975 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN 500 mg/1 N 20181231 21130-980_88f59f95-0a7c-458c-949c-0dff16ad94e4 21130-980 HUMAN OTC DRUG Signature Care Cold and Hot Medicated Menthol PATCH TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part348 Safeway MENTHOL, UNSPECIFIED FORM 500 mg/1 N 20181231 21130-982_50bada64-3f27-4412-a9c1-18d2c9755a87 21130-982 HUMAN OTC DRUG signature care miconazole 3 Miconazole nitrate KIT 20151209 ANDA ANDA076357 Safeway N 20181231 21130-990_66c0f251-3577-470a-8240-3d7122532334 21130-990 HUMAN OTC DRUG Menstrual Relief Extra Strength Acetaminophen, Caffeine, Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 Better Living Brands, LLC ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 21130-993_4a7a08c1-8e2e-4d21-8831-0e5ff26d3923 21130-993 HUMAN OTC DRUG Signature Care Hydrocortisone hydrocortisone CREAM TOPICAL 20151110 OTC MONOGRAPH NOT FINAL part348 Safeway HYDROCORTISONE 1 g/100g N 20181231 21130-994_786e7c03-b858-4cc4-aa25-c955f40d843d 21130-994 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide LIQUID ORAL 20160204 OTC MONOGRAPH NOT FINAL part334 Better Living Brands, LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 21130-995_65ef2b3a-168c-4b44-ac0c-7ebb62208648 21130-995 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide LIQUID ORAL 20160204 OTC MONOGRAPH NOT FINAL part334 Better Living Brands, LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 21130-996_857f61bf-4d43-4871-93f9-725352bf6d7a 21130-996 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide LIQUID ORAL 20160204 OTC MONOGRAPH NOT FINAL part334 Better Living Brands, LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 21220-119_63541b08-c5e4-4588-83d4-b67fdc898b73 21220-119 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19720601 NDA NDA205849 General Air Service & Supply Co OXYGEN 995 mL/L N 20181231 21220-120_32de8a2c-7cf5-49b5-add0-f3f9e4af414f 21220-120 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19740801 NDA NDA205850 General Air Service & Supply Co NITROGEN 999 mL/L N 20181231 21220-121_60df2cd6-0dae-6002-e053-2a91aa0ab87b 21220-121 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19580101 NDA NDA205912 General Air Service & Supply Co HELIUM 990 mL/L N 20191231 21220-122_f0301f13-cf0d-435a-9f49-1037e97809a6 21220-122 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19761101 NDA NDA205704 General Air Service & Supply Co NITROUS OXIDE 995 mL/L N 20181231 21220-123_60d85a36-784b-4884-a440-34e1bdf24c4b 21220-123 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19720601 NDA NDA207166 General Air Service & Supply Co. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 21220-124_b857067f-30e2-4b5d-86b2-7729ec75eb27 21220-124 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19740801 UNAPPROVED MEDICAL GAS General Air Service & Supply Co AIR 990 mL/L E 20171231 21220-125_5fd44dc8-d31f-4da0-b534-e38b0e17d2f5 21220-125 HUMAN PRESCRIPTION DRUG Carbon Dioxide Air Mixture Carbon Dioxide Air Mixture GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS General Air Service & Supply Co CARBON DIOXIDE; AIR 50; 950 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 21220-127_36e702f1-4f5d-4286-a650-3d0ccbe2f16d 21220-127 HUMAN PRESCRIPTION DRUG Helium/Oxygen Mixture 80/20 Helium/Oxygen Mixture 80/20 GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS General Air Service & Supply Co HELIUM; OXYGEN 800; 200 mL/L; mL/L E 20171231 21220-128_5f843e2c-2800-4d2f-811b-9b3858be7c2b 21220-128 HUMAN PRESCRIPTION DRUG Helium/Oxygen Mixture 70/30 Helium/Oxygen Mixture 70/30 GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS General Air Service & Supply Co HELIUM; OXYGEN 700; 300 mL/L; mL/L E 20171231 21220-129_0a9fb947-5870-490f-b6b9-be3c36088b14 21220-129 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture Carbon Dioxide Oxygen Mixture GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS General Air Service & Supply Co CARBON DIOXIDE; OXYGEN 200; 800 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 21220-130_d34c48bf-c479-4a96-af20-9cfbefd6b197 21220-130 HUMAN PRESCRIPTION DRUG Oxygen Nitrogen Mixture Oxygen Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19750101 NDA NDA205849 General Air Service & Supply Co. OXYGEN 200 mL/L N 20181231 21220-152_60df0f08-6625-6cb5-e053-2a91aa0a7760 21220-152 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19740801 NDA NDA205849 General Air Service & Supply Co OXYGEN 210 mL/L N 20191231 21220-155_60df34a1-e3fb-6959-e053-2a91aa0a4760 21220-155 HUMAN PRESCRIPTION DRUG Helium/Oxygen Mixture 80/20 Helium/Oxygen Mixture 80/20 GAS RESPIRATORY (INHALATION) 19750101 NDA NDA205849 General Air Service & Supply Co. OXYGEN 200 mL/L N 20181231 21220-156_60df34a1-e3f5-6959-e053-2a91aa0a4760 21220-156 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture Carbon Dioxide Oxygen Mixture GAS RESPIRATORY (INHALATION) 19750101 NDA NDA205849 General Air Service & Supply Co OXYGEN 800 mL/L N 20191231 21220-157_60df204a-1886-5dbc-e053-2a91aa0ae160 21220-157 HUMAN PRESCRIPTION DRUG Carbon Dioxide Air Mixture Carbon Dioxide Air Mixture GAS RESPIRATORY (INHALATION) 19750101 NDA NDA205852 General Air Service & Supply Co CARBON DIOXIDE 50 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20191231 21220-158_60df0f08-6615-6cb5-e053-2a91aa0a7760 21220-158 HUMAN PRESCRIPTION DRUG Helium/Oxygen Mixture 70/30 Helium/Oxygen Mixture 70/30 GAS RESPIRATORY (INHALATION) 19750101 NDA NDA205849 General Air Service & Supply Co OXYGEN 300 mL/L N 20191231 21221-001_df8b9a53-99a9-4a5f-a687-1657f3bce7c8 21221-001 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20060303 NDA NDA205850 General Cryogenic Technologies LLC NITROGEN 990 mL/L N 20181231 21221-002_8ff1ea8e-17fd-49ff-a015-4b7096686d97 21221-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060303 NDA NDA205849 General Cryogenic Technologies LLC OXYGEN 995 mL/L N 20181231 21532-1410_63300bac-56fe-4778-b568-af76a583ba5b 21532-1410 HUMAN OTC DRUG SaniKlean E3 Hand Sanitizer Alcohol LIQUID TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333A Bunzl Processor Distribution LLC ALCOHOL 70 mL/100mL N 20181231 21532-5572_18802008-cc21-46be-8563-23b9474eafb5 21532-5572 HUMAN OTC DRUG SEPTISURGE CHLOROXYLENOL SOAP TOPICAL 20140214 OTC MONOGRAPH NOT FINAL part333E BUNZL DISTRIBUTION CHLOROXYLENOL 2.5 g/1000mL E 20171231 21550-123_4e1451c1-2a63-4318-e054-00144ff88e88 21550-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20161026 UNAPPROVED MEDICAL GAS All Med, LLC OXYGEN 99 L/100L N 20181231 21624-001_44d4452d-bbce-4002-a5d9-02de2e4b6835 21624-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19500101 NDA NDA205889 Island Supply Welding Co Inc OXYGEN 995 mL/L N 20181231 21695-002_217e52b5-3a7b-4bbe-af3c-b18de7d426c3 21695-002 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Rebel Distributors Corp. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-003_217e52b5-3a7b-4bbe-af3c-b18de7d426c3 21695-003 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Rebel Distributors Corp. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-004_217e52b5-3a7b-4bbe-af3c-b18de7d426c3 21695-004 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Rebel Distributors Corp. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-005_217e52b5-3a7b-4bbe-af3c-b18de7d426c3 21695-005 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Rebel Distributors Corp. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-006_76c7e13d-37a0-4131-a1f1-fd5af0f60d3e 21695-006 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20091015 ANDA ANDA078858 Rebel Distributors Corp LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-007_457a2359-e7bc-4d23-a064-439989aa208d 21695-007 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20070101 OTC MONOGRAPH NOT FINAL part343 Rebel Distributors Corp ACETAMINOPHEN 325 mg/1 E 20171231 21695-008_457a2359-e7bc-4d23-a064-439989aa208d 21695-008 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20070101 OTC MONOGRAPH NOT FINAL part343 Rebel Distributors Corp ACETAMINOPHEN 500 mg/1 E 20171231 21695-009_a2db7131-bf31-47bf-bf61-594f919af1f2 21695-009 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir CAPSULE ORAL 19981030 ANDA ANDA074975 Rebel Distributors Corp ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 21695-010_a2db7131-bf31-47bf-bf61-594f919af1f2 21695-010 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 19981030 ANDA ANDA074980 Rebel Distributors Corp ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 21695-011_a2db7131-bf31-47bf-bf61-594f919af1f2 21695-011 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 19981030 NDA AUTHORIZED GENERIC NDA074980 Rebel Distributors Corp ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 21695-012_b9776e0b-8fc5-4d16-a5e2-482b806abb16 21695-012 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Rebel Distributors Corp. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 21695-013_b9776e0b-8fc5-4d16-a5e2-482b806abb16 21695-013 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 Rebel Distributors Corp. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 21695-014_14878615-b39c-477e-b33d-dd9753c7a3cf 21695-014 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20040701 ANDA ANDA072824 Rebel Distributors Corp. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 21695-015_14878615-b39c-477e-b33d-dd9753c7a3cf 21695-015 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20040701 ANDA ANDA072825 Rebel Distributors Corp. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 21695-016_76c7e13d-37a0-4131-a1f1-fd5af0f60d3e 21695-016 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20091015 ANDA ANDA078858 Rebel Distributors Corp LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-017_725b405d-a6e5-4ad6-820f-4fdebcbfe9fe 21695-017 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Rebel Distributors Corp. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 21695-018_725b405d-a6e5-4ad6-820f-4fdebcbfe9fe 21695-018 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Rebel Distributors Corp. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 21695-019_5649e22a-aec5-4bb8-83d7-35623185bd34 21695-019 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090901 ANDA ANDA079095 Rebel Distributors Corp. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 21695-020_5649e22a-aec5-4bb8-83d7-35623185bd34 21695-020 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090901 ANDA ANDA079095 Rebel Distributors Corp. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 21695-022_c4ec3cc2-8574-4134-970e-26a82c5dbc0e 21695-022 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Rebel Distributors Corp. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-023_c4ec3cc2-8574-4134-970e-26a82c5dbc0e 21695-023 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Rebel Distributors Corp. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-024_f82ee9e3-5119-4be0-883c-5831386baef6 21695-024 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Rebel Distributors Corp LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-025_d42b0f1d-8930-4b69-9624-8d6c500caba8 21695-025 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090801 ANDA ANDA077789 Rebel Distributors Corp CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] E 20171231 21695-027_f82ee9e3-5119-4be0-883c-5831386baef6 21695-027 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Rebel Distributors Corp LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-028_a2e793ab-7e78-463d-9bad-312af00f2e88 21695-028 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Rebel Distributors Corp. TADALAFIL 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 21695-029_a2e793ab-7e78-463d-9bad-312af00f2e88 21695-029 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Rebel Distributors Corp. TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 21695-030_a0fdcf12-0e79-4814-910f-5f4cc7463c13 21695-030 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20070327 ANDA ANDA078216 Rebel Distributors Corp. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-031_a0fdcf12-0e79-4814-910f-5f4cc7463c13 21695-031 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20070327 ANDA ANDA078216 Rebel Distributors Corp. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-032_a0fdcf12-0e79-4814-910f-5f4cc7463c13 21695-032 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20070327 ANDA ANDA078216 Rebel Distributors Corp. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-033_da1d371a-5541-468f-985b-6e4e214b7c16 21695-033 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE ORAL 20010202 ANDA ANDA065061 Rebel Distributors Corp CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 21695-034_da1d371a-5541-468f-985b-6e4e214b7c16 21695-034 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE ORAL 20010202 ANDA ANDA065061 Rebel Distributors Corp CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 21695-035_8e1058cf-1bd4-4c81-81a5-3a1754caca3f 21695-035 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C Rebel Distributors Corp CLOTRIMAZOLE 1 g/100g E 20171231 21695-036_caf7ed82-954c-498b-82bc-39fd903ab030 21695-036 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20060419 ANDA ANDA077563 Rebel Distributors CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 21695-037_3290187a-7eb6-4067-ac9e-fc8dfc722e0e 21695-037 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 Rebel Distributors CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 21695-038_6b7fb6b7-2f58-4cb6-b48f-e9b4cf292365 21695-038 HUMAN PRESCRIPTION DRUG diclofenac sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Rebel Distributors Corp DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-039_6b7fb6b7-2f58-4cb6-b48f-e9b4cf292365 21695-039 HUMAN PRESCRIPTION DRUG diclofenac sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Rebel Distributors Corp DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-040_51b4f63e-03fd-40f4-804b-39fd80842fd6 21695-040 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Extended-Release Diclofenac Sodium TABLET, EXTENDED RELEASE ORAL 20020107 ANDA ANDA075910 Rebel Distributors Corp. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-041_f82ee9e3-5119-4be0-883c-5831386baef6 21695-041 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Rebel Distributors Corp LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-043_487b4138-f7db-480f-96d2-8010fd5c0c06 21695-043 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 Rebel Distributors Corp NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 21695-044_d583b8b9-e5c7-45d6-8fc1-d51f51a16181 21695-044 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19841107 ANDA ANDA062396 Rebel Distributors Corp DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 21695-045_8a2302ca-5c25-4d2d-9ffe-320080934aab 21695-045 HUMAN PRESCRIPTION DRUG Effexor XR Extended-Release venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-046_8a2302ca-5c25-4d2d-9ffe-320080934aab 21695-046 HUMAN PRESCRIPTION DRUG Effexor XR Extended-Release venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-047_8a2302ca-5c25-4d2d-9ffe-320080934aab 21695-047 HUMAN PRESCRIPTION DRUG Effexor XR Extended-Release venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-048_96c89e90-4db0-49df-bf0e-62991cc1dadb 21695-048 HUMAN OTC DRUG ORGAN-I NR guaifenesin TABLET ORAL 20020701 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp GUAIFENESIN 200 mg/1 E 20171231 21695-049_db60911a-2bb1-4e8c-baf0-7cf281bf5778 21695-049 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE, GELATIN COATED ORAL 19990916 ANDA ANDA075126 Rebel Distributors Corp ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-050_d7cf7ed9-d7b4-4dcc-8a25-a9177c54f847 21695-050 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Rebel Distributors Corp ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-052_a1575590-4bdd-4f66-91fb-337e5f681747 21695-052 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Rebel Distributors Corp FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-053_a1575590-4bdd-4f66-91fb-337e5f681747 21695-053 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Rebel Distributors Corp FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-054_e6c2595a-1470-4cf4-93ea-0fedf917cf85 21695-054 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Rebel Distributors Corp FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-055_6f3e6391-e711-42bd-9d95-ce15d7a44ed5 21695-055 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20090924 ANDA ANDA075360 Rebel Distributors Corp. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-056_6f3e6391-e711-42bd-9d95-ce15d7a44ed5 21695-056 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20060829 ANDA ANDA075360 Rebel Distributors Corp. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-058_95ceac2d-ce96-4d9d-9fe6-893940f1decb 21695-058 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Rebel Distributors Corp. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-059_95ceac2d-ce96-4d9d-9fe6-893940f1decb 21695-059 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Rebel Distributors Corp. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-060_a3aa96bb-2cc1-4316-b94c-61593e927505 21695-060 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-061_a3aa96bb-2cc1-4316-b94c-61593e927505 21695-061 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-062_a3aa96bb-2cc1-4316-b94c-61593e927505 21695-062 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-063_a3aa96bb-2cc1-4316-b94c-61593e927505 21695-063 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-065_7b4858fc-fea6-4e4c-886e-a2febe1ed2c3 21695-065 HUMAN OTC DRUG Ibuprofen (NSAID) Pain Releiver/ Fever Reducer Ibuprofen (NSAID) TABLET ORAL 20091216 ANDA ANDA071333 Rebel Distributors Corp IBUPROFEN 200 mg/1 E 20171231 21695-066_79505457-733c-4253-ac74-fa864b1a9e55 21695-066 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Rebel Distributors Corp IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-067_79505457-733c-4253-ac74-fa864b1a9e55 21695-067 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Rebel Distributors Corp IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-068_79505457-733c-4253-ac74-fa864b1a9e55 21695-068 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Rebel Distributors Corp IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-069_7997e6da-7e98-4520-9d1b-0b8341bac64a 21695-069 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Rebel Distributors Corp TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 21695-070_d1329893-a8bc-4f31-a31b-76690d111035 21695-070 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET ORAL 20000424 NDA NDA021035 Rebel Distributors Corp LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-071_76c7e13d-37a0-4131-a1f1-fd5af0f60d3e 21695-071 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20091015 ANDA ANDA078858 Rebel Distributors Corp LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-072_2e8fb017-8754-421a-a76a-c41b8f48070b 21695-072 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 Rebel Distributors Corp RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-076_145dbdd2-123e-4b06-ac03-4e08619b50f6 21695-076 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET 20061220 ANDA ANDA077927 Rebel Distributors Corp. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-077_145dbdd2-123e-4b06-ac03-4e08619b50f6 21695-077 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20061220 ANDA ANDA077927 Rebel Distributors Corp. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-078_2e5d447c-a50c-4905-b56f-32fe86824dd9 21695-078 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Rebel Distributors Corp. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 21695-079_2e5d447c-a50c-4905-b56f-32fe86824dd9 21695-079 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19760818 ANDA ANDA085123 Rebel Distributors Corp. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 21695-080_98d480de-4089-477f-a049-0e09c59c5332 21695-080 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 Rebel Distributors Corp. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-081_18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8 21695-081 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Rebel Distributors Corp. MIRTAZAPINE 15 mg/1 E 20171231 21695-082_18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8 21695-082 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Rebel Distributors Corp. MIRTAZAPINE 30 mg/1 E 20171231 21695-083_18fbbcbb-73bd-4d22-8f4e-9a2777f0daf8 21695-083 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Rebel Distributors Corp. MIRTAZAPINE 45 mg/1 E 20171231 21695-084_a04bcc67-1f1a-4669-bb69-77738a939944 21695-084 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Rebel Distributors Corp. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-085_a04bcc67-1f1a-4669-bb69-77738a939944 21695-085 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Rebel Distributors Corp. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-086_a04bcc67-1f1a-4669-bb69-77738a939944 21695-086 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Rebel Distributors Corp. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-087_2e8fb017-8754-421a-a76a-c41b8f48070b 21695-087 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 Rebel Distributors Corp RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-088_456815fd-1e98-43fa-8f20-47cc3b8a15bd 21695-088 HUMAN OTC DRUG Naproxen Pain Relief Naproxen Sodium TABLET ORAL 19980312 ANDA ANDA074661 Rebel Distributors Corp NAPROXEN SODIUM 220 mg/1 E 20171231 21695-089_2e8fb017-8754-421a-a76a-c41b8f48070b 21695-089 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 Rebel Distributors Corp RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-090_0c01cb34-0d6b-4248-afde-82d4d934dabd 21695-090 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Rebel Distributors Corp NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-091_ea79f802-e9ac-480b-91e6-1e3900b11803 21695-091 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20110708 NDA NDA021153 Rebel Distributors Corp ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 21695-092_ea79f802-e9ac-480b-91e6-1e3900b11803 21695-092 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20110708 NDA NDA021153 Rebel Distributors Corp ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 21695-093_03601ccc-4a9a-4cb9-9028-281bbed42182 21695-093 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920330 ANDA ANDA073553 Rebel Distributors Corp NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 21695-094_03601ccc-4a9a-4cb9-9028-281bbed42182 21695-094 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920330 ANDA ANDA073554 Rebel Distributors Corp NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 21695-095_2e8fb017-8754-421a-a76a-c41b8f48070b 21695-095 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 Rebel Distributors Corp RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-096_2e8fb017-8754-421a-a76a-c41b8f48070b 21695-096 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 Rebel Distributors Corp RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-097_b6939539-2d45-4ea0-9744-72d7691e331f 21695-097 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20030903 ANDA ANDA075410 Rebel Distributors Corp. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 21695-098_b6939539-2d45-4ea0-9744-72d7691e331f 21695-098 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 Rebel Distributors Corp. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 21695-099_34769dda-f555-460e-9064-98ab205393c5 21695-099 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Rebel Distributors Corp ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 21695-100_e77d2b9e-84df-4733-b654-16e93618efce 21695-100 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20100908 ANDA ANDA075849 Rebel Distributors Corp OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-101_0d4fb45b-e45b-4519-96a3-a8a106450f87 21695-101 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Rebel Distributors Corp PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-102_0d4fb45b-e45b-4519-96a3-a8a106450f87 21695-102 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077854 Rebel Distributors Corp PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-103_0d4fb45b-e45b-4519-96a3-a8a106450f87 21695-103 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Rebel Distributors Corp PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-104_0d4fb45b-e45b-4519-96a3-a8a106450f87 21695-104 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Rebel Distributors Corp PAROXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-105_23bb4390-7825-4b2c-9dd9-48d2ee90bc6c 21695-105 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080501 NDA NDA020859 Rebel Distributors Corp. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 21695-106_d15c8f36-4dcc-4b28-b03c-4e81b2f9ad2e 21695-106 HUMAN PRESCRIPTION DRUG Prevacid SoluTab lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20020830 NDA NDA021428 Rebel Distributors Corp LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 21695-107_7332e0ea-fbd0-43fb-8d1e-f7068504c61d 21695-107 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 NDA NDA078525 Rebel Distributors Corp LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 21695-108_cfeacb5c-8b1b-48f6-9acf-00044a8179b4 21695-108 HUMAN PRESCRIPTION DRUG Protonix pantoprazoel sodium TABLET, DELAYED RELEASE ORAL 20010828 NDA NDA020987 Rebel Distributors Corp PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 21695-109_dcee67ac-e58c-4050-ad16-f8253a17036b 21695-109 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091217 ANDA ANDA077824 Rebel Distributors RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 21695-110_dcee67ac-e58c-4050-ad16-f8253a17036b 21695-110 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091217 ANDA ANDA077824 Rebel Distributors RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 21695-111_fce17e4f-926c-4b50-8fd6-f415d1a13570 21695-111 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate sodium TABLET ORAL 19901015 ANDA ANDA081099 Rebel Distributors Corp METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 21695-112_77215d87-ad22-4169-bd5f-a453f10b21ef 21695-112 HUMAN PRESCRIPTION DRUG Androgel testosterone GEL TRANSDERMAL 20030605 NDA NDA021015 Rebel Distributors Corp. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 21695-113_fca1c3cd-45f3-45cc-bb1d-656c65e91c8a 21695-113 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Rebel Distributors Corp RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-114_49860a2f-92f2-4da8-b78f-0efc005d725a 21695-114 HUMAN PRESCRIPTION DRUG Clomiphene Citrate Clomiphene Citrate TABLET ORAL 19990830 ANDA ANDA075528 Rebel Distributors Corp CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 21695-115_fca1c3cd-45f3-45cc-bb1d-656c65e91c8a 21695-115 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Rebel Distributors Corp RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-117_3dc79540-2f24-4920-99cd-ef6482f68eb2 21695-117 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Rebel Distributors Corp QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-118_3dc79540-2f24-4920-99cd-ef6482f68eb2 21695-118 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Rebel Distributors Corp QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-119_3dc79540-2f24-4920-99cd-ef6482f68eb2 21695-119 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Rebel Distributors Corp QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-120_3dc79540-2f24-4920-99cd-ef6482f68eb2 21695-120 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Rebel Distributors Corp QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-121_e53a8376-7107-473a-aa89-2cebee415864 21695-121 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20050325 ANDA ANDA077152 Rebel Distributors Corp TERBUTALINE SULFATE 5 mg/1 E 20171231 21695-122_e53a8376-7107-473a-aa89-2cebee415864 21695-122 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20050325 ANDA ANDA077152 Rebel Distributors Corp TERBUTALINE SULFATE 2.5 mg/1 E 20171231 21695-123_cb47d76e-a7e3-4bac-8074-8d7e95c6a6eb 21695-123 HUMAN PRESCRIPTION DRUG Skelaxin Metaxalone TABLET ORAL 19620813 NDA NDA013217 Rebel Distributors Corp METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 21695-124_33434f66-1d36-4506-9b3d-9755c978d9b2 21695-124 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19710401 ANDA ANDA061454 Rebel Distributors Corp DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 21695-125_78b559bd-44e8-45d2-96dc-5827b5f2caec 21695-125 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100225 ANDA ANDA076899 Rebel Distributors Corp. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 21695-126_03fa46db-3676-4e0b-876d-5d226036b73e 21695-126 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20070206 ANDA ANDA076347 Rebel Distributors TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 21695-127_03fa46db-3676-4e0b-876d-5d226036b73e 21695-127 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20070206 ANDA ANDA076347 Rebel Distributors TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 21695-128_202b1a2a-11dc-4c3d-aa53-27512a98a042 21695-128 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Rebel Distributors Corp TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 21695-129_202b1a2a-11dc-4c3d-aa53-27512a98a042 21695-129 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Rebel Distributors Corp TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 21695-130_202b1a2a-11dc-4c3d-aa53-27512a98a042 21695-130 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Rebel Distributors Corp TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 21695-131_8e80f9d8-2577-4fd9-a455-e6c6dc244c3a 21695-131 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Rebel Distributors Corp FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 21695-132_ba1be142-668f-41de-a545-852e1e8ff852 21695-132 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20091123 ANDA ANDA076003 Rebel Distributors Corp. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 21695-133_370453cb-7636-43f2-93f0-e8714884fab4 21695-133 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone TABLET ORAL 19871211 ANDA ANDA071523 Rebel Distributors Corp. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 21695-134_370453cb-7636-43f2-93f0-e8714884fab4 21695-134 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone TABLET ORAL 19871211 ANDA ANDA071524 Rebel Distributors Corp. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 21695-135_370453cb-7636-43f2-93f0-e8714884fab4 21695-135 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone TABLET ORAL 19880309 ANDA ANDA071525 Rebel Distributors Corp. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 21695-136_76c7e13d-37a0-4131-a1f1-fd5af0f60d3e 21695-136 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20091015 ANDA ANDA078858 Rebel Distributors Corp LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-137_fdd1fa5e-9dbf-4951-a8e9-33d06e05bdba 21695-137 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20091223 NDA NDA021515 Rebel Distributors Corp BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 21695-138_fdd1fa5e-9dbf-4951-a8e9-33d06e05bdba 21695-138 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20091223 NDA NDA021515 Rebel Distributors Corp BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 21695-139_aa9bfa49-c3b3-419d-a283-5ea0fd6fc3a0 21695-139 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, and Caffeine butalbital, aspirin, and caffeine CAPSULE ORAL 20030918 ANDA ANDA086231 Rebel Distributors Corp BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII E 20171231 21695-140_a3c9ea17-3793-494a-8b32-44e48f9f4503 21695-140 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Rebel Distributors Corp OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-141_2d821387-4b4f-4fe3-825e-750f49755baf 21695-141 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20100407 ANDA ANDA089684 Rebel Distributors Corp PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 21695-142_a3c9ea17-3793-494a-8b32-44e48f9f4503 21695-142 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Rebel Distributors Corp OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-143_750e7372-022b-454e-86c4-e4b325fb9f42 21695-143 HUMAN PRESCRIPTION DRUG ULTRACET tramadol hydrochloride and acetaminophen TABLET ORAL 20010815 NDA NDA021123 Rebel Distributors Corp TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 21695-144_a3c9ea17-3793-494a-8b32-44e48f9f4503 21695-144 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20010301 NDA NDA020592 Rebel Distributors Corp OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-145_7c38b799-9341-4962-914b-fec751123b29 21695-145 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Rebel Distributors Corp. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-146_7c38b799-9341-4962-914b-fec751123b29 21695-146 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Rebel Distributors Corp. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-147_fd156adc-3174-44da-bff7-eeaef5983f18 21695-147 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 19990715 NDA NDA021073 Rebel Distributors Corp. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 21695-148_fd156adc-3174-44da-bff7-eeaef5983f18 21695-148 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 19990715 NDA NDA021073 Rebel Distributors Corp. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 21695-150_1f35ed70-4947-4d4d-b4c8-71ce520fc445 21695-150 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET ORAL 20060329 ANDA ANDA065308 Rebel Distributors Corp CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 21695-151_b00570ff-4081-4514-b45b-eb6f753450f5 21695-151 HUMAN PRESCRIPTION DRUG Norvasc amlodipine besylate TABLET ORAL 19920731 NDA NDA019787 Rebel Distributors Corp AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 21695-153_35eb525b-72a5-4ef9-a36a-531e9e6b3560 21695-153 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 19990401 NDA NDA020837 Rebel Distributors Corp LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 21695-154_a169b0c0-600f-4072-8ab7-fafc386eab80 21695-154 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate TABLET, FILM COATED ORAL 20031217 NDA NDA020132 Rebel Distributors Corp SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 21695-155_c9c9efaf-983f-4f72-9099-0957fee5396c 21695-155 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060317 ANDA ANDA077634 Rebel Distributors Corp ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 21695-156_dc47903e-8d29-43eb-a647-1e8d28232bb9 21695-156 HUMAN PRESCRIPTION DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 19950130 ANDA ANDA064028 Rebel Distributors Corp. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 21695-157_4d60822d-1c9b-494d-adb3-20fe921d9c58 21695-157 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 20030717 NDA NDA020895 Rebel Distributors Corp SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 21695-158_4d60822d-1c9b-494d-adb3-20fe921d9c58 21695-158 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 20100211 NDA NDA020895 Rebel Distributors Corp SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 21695-159_a73cf8ee-f99b-4972-8939-0d394a527134 21695-159 HUMAN PRESCRIPTION DRUG PAXIL CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020409 NDA NDA020936 Rebel Distributors Corp PAROXETINE HYDROCHLORIDE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-160_a73cf8ee-f99b-4972-8939-0d394a527134 21695-160 HUMAN PRESCRIPTION DRUG PAXIL CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020409 NDA NDA020936 Rebel Distributors Corp PAROXETINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-161_17dbfc4c-d62e-4efa-930d-29df7de69fa3 21695-161 HUMAN PRESCRIPTION DRUG Thiothixene Thiothixene CAPSULE ORAL 19870624 ANDA ANDA071529 Rebel Distributors Corp THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] E 20171231 21695-162_56145d1a-1c0c-4c39-951e-45b9f324abcb 21695-162 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Rebel Distributors Corp TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 21695-163_bfbc2cfb-8e96-4cf2-81c7-d63a1b7365c4 21695-163 HUMAN PRESCRIPTION DRUG Depakote Divalproex sodium TABLET, EXTENDED RELEASE ORAL 20100607 NDA NDA021168 Rebel Distributors Corp DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 21695-164_232a00a4-761e-422f-b62a-1a16de631eb6 21695-164 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077397 Rebel Distributors Corp SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-165_232a00a4-761e-422f-b62a-1a16de631eb6 21695-165 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077397 Rebel Distributors Corp SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-166_232a00a4-761e-422f-b62a-1a16de631eb6 21695-166 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077397 Rebel Distributors Corp SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-167_b7758662-dcd2-4a02-933f-8a3de70cf551 21695-167 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20060905 ANDA ANDA040684 Rebel Distributors Corp PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 21695-168_4150414d-ed40-4055-ab75-7e17627ce7c6 21695-168 HUMAN PRESCRIPTION DRUG MEPHYTON phytonadione TABLET ORAL 19550930 NDA NDA010104 Rebel Distributors Corp PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] E 20171231 21695-169_74ce605d-b493-4b95-9d59-9253f81f4e20 21695-169 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20041117 NDA NDA021487 Rebel Distributors Corp MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 21695-170_f15b043d-fcfa-4ade-a3da-76700c0c5c2a 21695-170 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus CAPSULE, GELATIN COATED ORAL 19940408 NDA NDA050708 Rebel Distributors Corp ANHYDROUS TACROLIMUS 1 mg/1 E 20171231 21695-171_23d74606-134c-464c-8323-9cf52bb3c5fa 21695-171 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil CAPSULE ORAL 19950503 NDA NDA050722 Rebel Distributors Corp MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] E 20171231 21695-172_0eefdd8d-7745-47ae-a204-f35687f3db11 21695-172 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Rebel Distributors Corp. BUSPIRONE HYDROCHLORIDE 15 mg/1 E 20171231 21695-173_d8b0abac-c32c-4bd0-8247-5c6d6a9fd17f 21695-173 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 Rebel Distributors Corp ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 21695-174_4afee435-ae60-4260-a1df-e52abf7a043d 21695-174 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Rebel Distributors Corp NEFAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 21695-175_4afee435-ae60-4260-a1df-e52abf7a043d 21695-175 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Rebel Distributors Corp NEFAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 21695-176_4afee435-ae60-4260-a1df-e52abf7a043d 21695-176 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Rebel Distributors Corp NEFAZODONE HYDROCHLORIDE 200 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 21695-177_4afee435-ae60-4260-a1df-e52abf7a043d 21695-177 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Rebel Distributors Corp NEFAZODONE HYDROCHLORIDE 250 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 21695-178_762daef1-2ad2-444d-958b-f0a69c8ac259 21695-178 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Rebel Distributors Corp PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-179_762daef1-2ad2-444d-958b-f0a69c8ac259 21695-179 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Rebel Distributors Corp PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-180_762daef1-2ad2-444d-958b-f0a69c8ac259 21695-180 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Rebel Distributors Corp PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-181_4a81751e-1c63-4b0d-8f63-bf7c4d155f22 21695-181 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20020702 ANDA ANDA076514 Rebel Distributors Corp MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 21695-182_338f1552-e06e-4a6b-bd67-60737684a617 21695-182 HUMAN PRESCRIPTION DRUG Thermazene Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 Rebel Distributors Corp SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 21695-183_3740dcc6-9ee8-4187-9112-632050043240 21695-183 HUMAN PRESCRIPTION DRUG Rozerem ramelteon TABLET, FILM COATED ORAL 20050722 NDA NDA021782 Rebel Distributors Corp RAMELTEON 8 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] E 20171231 21695-184_ea6968e3-6383-4ff1-8c81-e4a2fdfe749d 21695-184 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide TABLET, FILM COATED ORAL 20010228 NDA NDA021169 Rebel Distributors Corp GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 21695-185_9b245d7c-00c0-472e-b213-13fbe9973ee1 21695-185 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Nystatin and Triamcinolone Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364 Rebel Distributors Corp NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-186_e5a2f3a5-2b9d-4d02-ad5c-e6a890569363 21695-186 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium and Prednisolone Sodium Phosphate sulfacetamide sodium and prednisolone sodium phosphate SOLUTION OPHTHALMIC 19951229 ANDA ANDA074449 Rebel Distributors Corp SULFACETAMIDE SODIUM; PREDNISOLONE SODIUM PHOSPHATE 100; 2.5 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-187_d7a27e38-0553-4d4b-8438-fed235e9b989 21695-187 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION OPHTHALMIC 19841010 ANDA ANDA062452 Rebel Distributors Corp GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 21695-188_a76947bd-0430-4d79-b4c1-9d1746bc7f84 21695-188 HUMAN PRESCRIPTION DRUG Mupirocin mupirocin OINTMENT TOPICAL 20051130 ANDA ANDA065192 Rebel Distributors Corp. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 21695-189_063728a5-87b5-4b53-957a-d8e497fcf8b0 21695-189 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-191_15dd2f41-952b-40d2-a9bb-5e1cb8802e5e 21695-191 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Rebel Distributors Corp BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 21695-192_65b71a14-dcb5-4123-b4c5-033c9e16a22a 21695-192 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 Rebel Distributors Corp NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; mg/g; ug/g Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 21695-193_8e80f9d8-2577-4fd9-a455-e6c6dc244c3a 21695-193 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Rebel Distributors Corp FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 21695-194_75ab9c13-3227-4f20-a8a1-891a4380c085 21695-194 HUMAN OTC DRUG Triple Antibiotic Neomycin and Polymyxin B Sulfates and Bacitracin Zinc OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B Rebel Distributors Corp BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [USP'U]/g; mg/g; [USP'U]/g E 20171231 21695-195_4b044819-2959-4914-b564-d944201246fd 21695-195 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20090909 ANDA ANDA076008 Rebel Distributors Corp BUSPIRONE HYDROCHLORIDE 30 mg/1 E 20171231 21695-196_9e0bdea8-df9b-4873-b24b-919cebff5edd 21695-196 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER ORAL; RESPIRATORY (INHALATION) 20010205 NDA NDA021077 Rebel Distributors Corp. SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 250 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-197_9e0bdea8-df9b-4873-b24b-919cebff5edd 21695-197 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER ORAL; RESPIRATORY (INHALATION) 20010305 NDA NDA021077 Rebel Distributors Corp. SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 500 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-198_29d24a6d-f9c1-4300-97c7-fec26bdbc22b 21695-198 HUMAN PRESCRIPTION DRUG Albuterol Albuterol AEROSOL, METERED ORAL 19960814 ANDA ANDA072273 Rebel Distributors Corp ALBUTEROL 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 21695-201_df79a35c-ce5c-452e-b81e-50a014fc94f4 21695-201 HUMAN PRESCRIPTION DRUG clobetasol propionate clobetasol propionate CREAM TOPICAL 19960930 ANDA ANDA074392 Rebel Distributors Corp CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-202_848653f3-ea81-4416-94a5-9dc0327cd2e3 21695-202 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Rebel Distributors Corp CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 21695-203_330ac1f7-d583-454d-96bf-37c5af31a369 21695-203 HUMAN PRESCRIPTION DRUG TobraDex tobramycin and dexamethasone SUSPENSION OPHTHALMIC 19880818 NDA NDA050592 Rebel Distributors Corp TOBRAMYCIN; DEXAMETHASONE 3; 1 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-204_f54c1882-ca08-47f3-9c02-93551f39905e 21695-204 HUMAN PRESCRIPTION DRUG Tobramycin tobramycin SOLUTION OPHTHALMIC 19940525 ANDA ANDA063176 Rebel Distributors Corp TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 21695-205_56145d1a-1c0c-4c39-951e-45b9f324abcb 21695-205 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Rebel Distributors Corp TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 21695-206_3bff1c25-c6c2-4c7d-a14e-be7c3c3d4ab8 21695-206 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19861216 ANDA ANDA089414 Rebel Distributors Corp HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-208_48b10c63-5d7a-4841-9faa-17ac3d4873d1 21695-208 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Rebel Distributors Corp HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 21695-209_fef4844c-2b44-4e5c-9da3-e5b2214c9e8d 21695-209 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 Rebel Distributors Corp BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 21695-210_b5e00846-c681-472a-a8eb-78215e6d8a1b 21695-210 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 Rebel Distributors Corp. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-211_c298d925-bf40-442d-9041-dea5c50fb60b 21695-211 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 20090630 NDA NDA019908 Rebel Distributors Corp. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 21695-212_c298d925-bf40-442d-9041-dea5c50fb60b 21695-212 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 20090630 NDA NDA019908 Rebel Distributors Corp. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 21695-213_e242ca9c-63bc-44a3-abcf-99632e7703fa 21695-213 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20090630 NDA NDA021774 Rebel Distributors Corp. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 21695-214_6d794bf5-8ce7-449c-9cc5-d3b6b0380cfb 21695-214 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021030 ANDA ANDA065101 Rebel Distributors Corp. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 21695-215_6d794bf5-8ce7-449c-9cc5-d3b6b0380cfb 21695-215 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021029 ANDA ANDA065096 Rebel Distributors Corp. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 21695-217_0eefdd8d-7745-47ae-a204-f35687f3db11 21695-217 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Rebel Distributors Corp. BUSPIRONE HYDROCHLORIDE 10 mg/1 E 20171231 21695-218_1971dce3-875a-43e7-aafc-528600da92b5 21695-218 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine CAPSULE ORAL 19970228 ANDA ANDA040204 Rebel Distributors Corp. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 21695-219_8a8a81a4-6768-4ec0-b6ad-224788bcc59a 21695-219 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19990226 ANDA ANDA040230 Rebel Distributors Corp DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 21695-220_3607bed9-64f3-4b14-9b4d-7cc70dc8b185 21695-220 HUMAN PRESCRIPTION DRUG Estazolam Estazolam TABLET ORAL 19970819 ANDA ANDA074818 Rebel Distributors Corp ESTAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-221_78eea56d-15a6-4ceb-b755-d1a3e9707f32 21695-221 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 19980220 NDA NDA020829 Rebel Distributors Corp MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 21695-222_a8c12387-4b2b-49c2-b9c5-112ffb133950 21695-222 HUMAN PRESCRIPTION DRUG acetic acid acetic acid SOLUTION AURICULAR (OTIC) 20100122 NDA NDA012179 Rebel Distributors Corp ACETIC ACID 20.65 mg/mL E 20171231 21695-223_17a20462-d9d2-43ac-bcad-603e8cc76e3b 21695-223 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19950117 NDA NDA020241 Rebel Distributors Corp LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 21695-224_17a20462-d9d2-43ac-bcad-603e8cc76e3b 21695-224 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19950117 NDA NDA020241 Rebel Distributors Corp LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 21695-225_7b069c49-007c-4f77-878c-0a6c564e2717 21695-225 HUMAN PRESCRIPTION DRUG Lunesta eszopiclone TABLET, COATED ORAL 20090101 NDA NDA021476 Rebel Distributors Corp ESZOPICLONE 2 mg/1 CIV E 20171231 21695-226_7b069c49-007c-4f77-878c-0a6c564e2717 21695-226 HUMAN PRESCRIPTION DRUG Lunesta eszopiclone TABLET, COATED ORAL 20090101 NDA NDA021476 Rebel Distributors Corp ESZOPICLONE 3 mg/1 CIV E 20171231 21695-227_7332e0ea-fbd0-43fb-8d1e-f7068504c61d 21695-227 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 NDA NDA078525 Rebel Distributors Corp LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 21695-228_7332e0ea-fbd0-43fb-8d1e-f7068504c61d 21695-228 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 NDA NDA078525 Rebel Distributors Corp LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 21695-229_7332e0ea-fbd0-43fb-8d1e-f7068504c61d 21695-229 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 NDA NDA078525 Rebel Distributors Corp LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 21695-230_2564fc90-9492-448e-a64f-ee569d7853e6 21695-230 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Rebel Distributors Corp. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-231_2564fc90-9492-448e-a64f-ee569d7853e6 21695-231 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Rebel Distributors Corp. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-232_74ce605d-b493-4b95-9d59-9253f81f4e20 21695-232 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20060809 NDA NDA021487 Rebel Distributors Corp MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 21695-233_89f08066-5ea7-4830-ab8f-8c6a04952604 21695-233 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20110308 ANDA ANDA040545 Rebel Distributors Corp OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 21695-234_8b79d52e-e6e5-4aaf-8835-242c72d6ee38 21695-234 HUMAN PRESCRIPTION DRUG PROVIGIL MODAFINIL TABLET ORAL 20050603 NDA NDA020717 Rebel Distributors Corp MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV E 20171231 21695-235_8b79d52e-e6e5-4aaf-8835-242c72d6ee38 21695-235 HUMAN PRESCRIPTION DRUG PROVIGIL MODAFINIL TABLET ORAL 20040119 NDA NDA020717 Rebel Distributors Corp MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV E 20171231 21695-236_263d7146-791a-49a3-9886-7f4631ecf968 21695-236 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen tramadol hydrochloride and acetaminophen TABLET ORAL 20050421 ANDA ANDA076475 Rebel Distributors Corp TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 21695-237_a7839c4b-6e6e-444f-997e-2dbe28a80eaa 21695-237 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 Rebel Distributors Corp. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 21695-238_90d64ec4-e3af-4e78-bf7e-9d37699c98d2 21695-238 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19880415 ANDA ANDA071193 Rebel Distributors Corp LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-239_90d64ec4-e3af-4e78-bf7e-9d37699c98d2 21695-239 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19880415 ANDA ANDA071194 Rebel Distributors Corp LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-240_90d64ec4-e3af-4e78-bf7e-9d37699c98d2 21695-240 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19880415 ANDA ANDA071195 Rebel Distributors Corp LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-242_b0826efb-e191-4c84-a1cd-79306fe8ddf9 21695-242 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20090629 ANDA ANDA040419 Rebel Distributors Corp. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII E 20171231 21695-243_b0826efb-e191-4c84-a1cd-79306fe8ddf9 21695-243 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20090629 ANDA ANDA040419 Rebel Distributors Corp. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 CIII E 20171231 21695-244_50fca3de-4703-4eb7-8294-1ce8e860a100 21695-244 HUMAN OTC DRUG Childrens Silapap Acetaminophen LIQUID ORAL 19940905 OTC MONOGRAPH NOT FINAL part343 Rebel Distributors Corp ACETAMINOPHEN 160 mg/5mL E 20171231 21695-245_953ab65b-b157-41b3-8f90-98fa9d7f20c5 21695-245 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19980115 ANDA ANDA074543 Rebel Distributors Corp. ALBUTEROL SULFATE 5 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 21695-246_66e300a5-f1de-40e0-9b08-8b86e2394016 21695-246 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090601 ANDA ANDA018832 Rebel Distributors Corp. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 21695-247_4f300492-4080-499d-b872-a8bf9de3cc7c 21695-247 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19991229 ANDA ANDA074112 Rebel Distributors Corp. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-248_4f300492-4080-499d-b872-a8bf9de3cc7c 21695-248 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19991229 ANDA ANDA074112 Rebel Distributors Corp. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-249_4f300492-4080-499d-b872-a8bf9de3cc7c 21695-249 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19991229 ANDA ANDA074112 Rebel Distributors Corp. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-250_4f300492-4080-499d-b872-a8bf9de3cc7c 21695-250 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19980325 ANDA ANDA074909 Rebel Distributors Corp. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-251_a2368fd3-124e-476d-a8db-9c45e7423562 21695-251 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 Rebel Distributors Corp. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 21695-252_a2368fd3-124e-476d-a8db-9c45e7423562 21695-252 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 Rebel Distributors Corp. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 21695-253_a2368fd3-124e-476d-a8db-9c45e7423562 21695-253 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085967 Rebel Distributors Corp. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 21695-254_5721945b-269b-428d-9e99-b9da8dfb534f 21695-254 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20090302 ANDA ANDA077712 Rebel Distributors Corp OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 21695-255_a3c08a6d-f986-4efc-9f96-3f0e652704dc 21695-255 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Rebel Distributors Corp ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-256_0eefdd8d-7745-47ae-a204-f35687f3db11 21695-256 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Rebel Distributors Corp. BUSPIRONE HYDROCHLORIDE 5 mg/1 E 20171231 21695-257_6dd09be6-a345-4a42-9b64-51b7808ff45f 21695-257 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 20091215 ANDA ANDA040336 Rebel Distributors Corp. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 500; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 21695-259_2ef01a91-e73e-46d6-a6f9-d7d6dae91ea2 21695-259 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride ciprofloxacin hydrochloride SOLUTION OPHTHALMIC 19901231 NDA NDA019992 Rebel Distributors Corp CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-260_087a9ced-9e7b-460e-a825-a9c9f60359cf 21695-260 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090622 ANDA ANDA074569 Rebel Distributors CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-261_087a9ced-9e7b-460e-a825-a9c9f60359cf 21695-261 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090622 ANDA ANDA074569 Rebel Distributors CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-262_087a9ced-9e7b-460e-a825-a9c9f60359cf 21695-262 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090622 ANDA ANDA074569 Rebel Distributors CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-263_2d96a6cb-326f-4c04-b5d7-24d7f7c20699 21695-263 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091109 ANDA ANDA071307 Rebel Distributors Corp. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-264_2d96a6cb-326f-4c04-b5d7-24d7f7c20699 21695-264 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091109 ANDA ANDA071321 Rebel Distributors Corp. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-265_2d96a6cb-326f-4c04-b5d7-24d7f7c20699 21695-265 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091109 ANDA ANDA071322 Rebel Distributors Corp. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-268_b935625d-e9e6-4b5b-a40a-3f4e7f01fa45 21695-268 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20090922 ANDA ANDA076642 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 21695-272_64970a9e-6ab7-410d-820f-7e2c0e4dc494 21695-272 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100210 ANDA ANDA040746 Rebel Distributors Corp. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 21695-274_ba7676eb-68b0-4f64-aed9-541f0ad49bc8 21695-274 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040757 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 650 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 21695-276_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-276 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20050610 NDA NDA021724 Rebel Distributors Corp PREGABALIN 25 mg/1 CV E 20171231 21695-277_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-277 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20050610 NDA NDA021724 Rebel Distributors Corp PREGABALIN 50 mg/1 CV E 20171231 21695-278_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-278 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20050610 NDA NDA021724 Rebel Distributors Corp PREGABALIN 75 mg/1 CV E 20171231 21695-279_22009d23-999c-4fa6-bfe7-21395f577236 21695-279 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081126 ANDA ANDA077715 Rebel Distributors Corp BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 21695-282_6979644e-0587-4040-b754-5dce5eda87a4 21695-282 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 Rebel Distributors Corp TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-283_09abc9b1-50fc-4c60-a6a1-9772e35b057a 21695-283 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 Rebel Distributors Corp TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-284_1da7457b-7225-4950-8108-bbbd8f78f883 21695-284 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 19940601 ANDA ANDA074224 Rebel Distributors Corp TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-285_f1f62485-4f0a-4f7e-b450-62f9ce20f13f 21695-285 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20091112 ANDA ANDA074131 Rebel Distributors Corp PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-286_ecb65310-e54e-48f8-a61b-4177bac41252 21695-286 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20020813 ANDA ANDA072266 Rebel Distributors Corp BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 21695-287_3bf80420-7482-44c0-a117-30793ba89544 21695-287 HUMAN PRESCRIPTION DRUG Crestor Rosuvastatin calcium TABLET, FILM COATED ORAL 20031125 NDA NDA021366 Rebel Distributors Corp ROSUVASTATIN CALCIUM 10 mg/1 E 20171231 21695-288_3bf80420-7482-44c0-a117-30793ba89544 21695-288 HUMAN PRESCRIPTION DRUG Crestor Rosuvastatin calcium TABLET, FILM COATED ORAL 20040607 NDA NDA021366 Rebel Distributors Corp ROSUVASTATIN CALCIUM 20 mg/1 E 20171231 21695-290_0372f916-0a26-4115-8075-2d575bfbc15e 21695-290 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603 ANDA ANDA084613 Rebel Distributors Corp DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-291_0950cd08-a48b-4376-9647-da22cf5a8a70 21695-291 HUMAN PRESCRIPTION DRUG PULMICORT FLEXHALER Budesonide AEROSOL, POWDER RESPIRATORY (INHALATION) 20100730 NDA NDA021949 Rebel Distributors Corp BUDESONIDE 90 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-292_2fd193e2-7aa7-4119-b540-7e28e82fbd13 21695-292 HUMAN PRESCRIPTION DRUG ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20050908 NDA NDA021692 Rebel Distributors Corp TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 21695-294_5509ede4-74d3-42af-a1dd-cee95de5d2e6 21695-294 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Rebel Distributors Corp. AMOXICILLIN 400 mg/5mL E 20171231 21695-295_5649e22a-aec5-4bb8-83d7-35623185bd34 21695-295 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090901 ANDA ANDA079095 Rebel Distributors Corp. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 21695-298_8ff18a70-965a-4d3e-ae3e-b599c4e6763c 21695-298 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19961210 ANDA ANDA074644 Rebel Distributors Corp. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-299_8ff18a70-965a-4d3e-ae3e-b599c4e6763c 21695-299 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19961210 ANDA ANDA074644 Rebel Distributors Corp. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-300_047e8b1b-8888-40b7-b593-434e92eb333c 21695-300 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 19701125 ANDA ANDA080043 Rebel Distributors Corp NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 21695-302_5419f5dd-bf20-4eea-982d-33511a022c38 21695-302 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100323 ANDA ANDA060704 Rebel Distributors Corp TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 21695-303_1da7457b-7225-4950-8108-bbbd8f78f883 21695-303 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 20090713 ANDA ANDA074224 Rebel Distributors Corp TRIAZOLAM .125 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-304_c46e1443-dffe-47a9-bc9a-acbe3a8b0b41 21695-304 HUMAN OTC DRUG Diphenhydramine Diphenhydramine CAPSULE ORAL 20070101 OTC MONOGRAPH NOT FINAL part348 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 21695-305_9fde9268-d5e8-4402-a429-df55f075861d 21695-305 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19720522 ANDA ANDA080292 Rebel Distributors Corp PREDNISONE 5 mg/1 E 20171231 21695-306_9fde9268-d5e8-4402-a429-df55f075861d 21695-306 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19851204 ANDA ANDA088832 Rebel Distributors Corp PREDNISONE 10 mg/1 E 20171231 21695-307_9fde9268-d5e8-4402-a429-df55f075861d 21695-307 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 Rebel Distributors Corp PREDNISONE 20 mg/1 E 20171231 21695-308_e8782624-2e60-4fd3-ba49-bf51d314676b 21695-308 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070027 Rebel Distributors Corp METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 21695-309_e8782624-2e60-4fd3-ba49-bf51d314676b 21695-309 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070033 Rebel Distributors Corp METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 21695-310_e1cfadb7-7370-4735-a87a-071c6eedd87a 21695-310 HUMAN OTC DRUG Arthricream with Aloe Trolamine Salicylate CREAM TOPICAL 20060118 OTC MONOGRAPH NOT FINAL part352 Rebel Distributors Corp TROLAMINE SALICYLATE 10 g/100g E 20171231 21695-314_0b675f9b-1724-4d56-8e4a-396680de436d 21695-314 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 Rebel Distributors Corp. AMOXICILLIN 250 mg/1 E 20171231 21695-315_0b675f9b-1724-4d56-8e4a-396680de436d 21695-315 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 Rebel Distributors Corp. AMOXICILLIN 500 mg/1 E 20171231 21695-316_8bae9b61-3264-4cba-ad32-dfdec9259af3 21695-316 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Rebel Distributors Corp. CEPHALEXIN 250 mg/1 E 20171231 21695-317_8bae9b61-3264-4cba-ad32-dfdec9259af3 21695-317 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Rebel Distributors Corp. CEPHALEXIN 500 mg/1 E 20171231 21695-318_4cdff640-870e-4de8-885b-0669bfde518d 21695-318 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 19881123 ANDA ANDA062935 Rebel Distributors Corp PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 21695-319_e242ca9c-63bc-44a3-abcf-99632e7703fa 21695-319 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20090630 NDA NDA021774 Rebel Distributors Corp. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 21695-320_10a49211-025b-4d63-b60c-fadfd9b731c0 21695-320 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride TABLET, FILM COATED ORAL 20100113 ANDA ANDA075755 Rebel Distributors Corp FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-321_10a49211-025b-4d63-b60c-fadfd9b731c0 21695-321 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride TABLET, FILM COATED ORAL 20100113 ANDA ANDA075755 Rebel Distributors Corp FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-322_500ca21e-571b-4fa9-8b62-4914b226bf3e 21695-322 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950719 ANDA ANDA077877 Rebel Distributors Corp. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-323_d3e90e8f-d3c9-4c73-975f-206a28e0b103 21695-323 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19911227 ANDA ANDA073352 Rebel Distributors Corp. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-324_d3e90e8f-d3c9-4c73-975f-206a28e0b103 21695-324 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19911227 ANDA ANDA073352 Rebel Distributors Corp. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-325_65e1c3ae-a462-4345-8a28-c7d2c0388af8 21695-325 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Rebel Distributors Corp EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-326_56ffd662-60a6-4b43-a7ea-f778714dfbbd 21695-326 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Rebel Distributors Corp. D&C YELLOW NO. 10 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 21695-327_56ffd662-60a6-4b43-a7ea-f778714dfbbd 21695-327 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Rebel Distributors Corp. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 21695-328_612dfaac-f178-4880-b38d-2456478d738a 21695-328 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Rebel Distributors Corp LISINOPRIL 5 mg/1 E 20171231 21695-329_612dfaac-f178-4880-b38d-2456478d738a 21695-329 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Rebel Distributors Corp LISINOPRIL 10 mg/1 E 20171231 21695-330_612dfaac-f178-4880-b38d-2456478d738a 21695-330 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Rebel Distributors Corp LISINOPRIL 20 mg/1 E 20171231 21695-331_612dfaac-f178-4880-b38d-2456478d738a 21695-331 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Rebel Distributors Corp LISINOPRIL 40 mg/1 E 20171231 21695-332_fd41a51d-d569-4368-a3b1-a12cb2472754 21695-332 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 Rebel Distributors Corp. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 21695-333_b844e453-78ff-4c5f-b541-37d33f355a3a 21695-333 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20010529 ANDA ANDA075673 Rebel Distributors Corp CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .64 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-334_22b7f3d7-7f3e-437f-9326-3eef737edfbb 21695-334 HUMAN OTC DRUG Ear Wax Treatment Carbamide Peroxide SOLUTION/ DROPS AURICULAR (OTIC) 20091026 OTC MONOGRAPH FINAL part344 Rebel Distributors Corp CARBAMIDE PEROXIDE 81.86 mg/mL E 20171231 21695-335_cf4bd790-291e-4c35-83bb-205fb06753b6 21695-335 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim polymyxin B sulfate and trimethoprim SOLUTION OPHTHALMIC 19980413 ANDA ANDA064211 Rebel Distributors Corp POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 mL/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 21695-336_1b182a47-6803-4b84-882e-544306ab0329 21695-336 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20060131 ANDA ANDA040650 Rebel Distributors Corp CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV E 20171231 21695-337_b6c0ff30-03f5-4c1b-9077-f0918cf40a91 21695-337 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 19971022 ANDA ANDA074655 Rebel Distributors Corp RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 21695-338_b6c0ff30-03f5-4c1b-9077-f0918cf40a91 21695-338 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 19971022 ANDA ANDA074655 Rebel Distributors Corp RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 21695-339_65e1c3ae-a462-4345-8a28-c7d2c0388af8 21695-339 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Rebel Distributors Corp EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-340_9bc31f67-cfce-4ad6-9c07-3845ead3542c 21695-340 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE ORAL 20100420 ANDA ANDA074035 Rebel Distributors Corp KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-341_9bc31f67-cfce-4ad6-9c07-3845ead3542c 21695-341 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE ORAL 20100420 ANDA ANDA074035 Rebel Distributors Corp KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-342_e475d997-09f2-46b7-9750-6f7c8f032f2b 21695-342 HUMAN OTC DRUG LubriFresh P.M. white petrolatum mineral oil OINTMENT OPHTHALMIC 20111209 OTC MONOGRAPH FINAL part349 Rebel Distributors Corp MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g E 20171231 21695-343_afebcc90-e2b5-416d-a041-db2dd593a648 21695-343 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20100602 ANDA ANDA075227 Rebel Distributors Corp NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-344_6f3e6391-e711-42bd-9d95-ce15d7a44ed5 21695-344 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20081107 ANDA ANDA075360 Rebel Distributors Corp. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-345_81210afd-6505-4d38-ab83-e276ee4ce144 21695-345 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 Rebel Distributors Corp LISINOPRIL 2.5 mg/1 E 20171231 21695-346_f32d6e27-5b7b-4b17-af2e-0250447ee560 21695-346 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20060101 ANDA ANDA071250 Rebel Distributors Corp. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 21695-347_4106f9a9-56f2-4c1e-bc52-3151d497c1a9 21695-347 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20100108 OTC MONOGRAPH FINAL part333B Rebel Distributors Corp BACITRACIN ZINC 500 [USP'U]/g E 20171231 21695-348_56145d1a-1c0c-4c39-951e-45b9f324abcb 21695-348 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Rebel Distributors Corp TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 21695-349_56145d1a-1c0c-4c39-951e-45b9f324abcb 21695-349 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Rebel Distributors Corp TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 21695-350_071e819b-43cd-48f7-b63e-c891936dcfc4 21695-350 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 19980130 ANDA ANDA074749 Rebel Distributors Corp ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 21695-352_848653f3-ea81-4416-94a5-9dc0327cd2e3 21695-352 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Rebel Distributors Corp CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 21695-353_d37b05cd-155b-4ac6-9892-7c82d2f65b5f 21695-353 HUMAN OTC DRUG Saline Mist Saline Mist SPRAY NASAL 20090424 OTC MONOGRAPH FINAL part349 Rebel Distributors Corp SODIUM CHLORIDE 6.5 mg/mL E 20171231 21695-354_4e10129b-41a3-4572-9564-6f8366b627dc 21695-354 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 20091215 ANDA ANDA086162 Rebel Distributors Corp BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII E 20171231 21695-356_48b10c63-5d7a-4841-9faa-17ac3d4873d1 21695-356 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Rebel Distributors Corp HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 21695-357_5d7c4d41-2df4-42d4-9a3d-0a567519bf2d 21695-357 HUMAN PRESCRIPTION DRUG Exelon rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20091007 NDA NDA022083 Rebel Distributors Corp RIVASTIGMINE 4.6 mg/24[USP'U] Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 21695-358_8cfa527c-69c5-4722-8246-c3b4ce591a5f 21695-358 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SOLUTION TOPICAL 19981113 ANDA ANDA075205 Rebel Distributors Corp CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-359_bfbc2cfb-8e96-4cf2-81c7-d63a1b7365c4 21695-359 HUMAN PRESCRIPTION DRUG Depakote Divalproex sodium TABLET, EXTENDED RELEASE ORAL 20100607 NDA NDA021168 Rebel Distributors Corp DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 21695-360_656a9b7a-77cc-4fd1-917d-788e046e269c 21695-360 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20090601 NDA NDA014901 Rebel Distributors TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-361_0bfe9d76-1b0e-47a4-831d-097168d66577 21695-361 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010228 NDA NDA021077 Rebel Distributors Corp SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 100 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-362_20f8c35b-bf1c-44cf-bdd7-01b56b85bc0c 21695-362 HUMAN PRESCRIPTION DRUG Kaletra lopinavir and ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 Rebel Distributors Corp LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA] E 20171231 21695-363_16a5de2d-2f89-4fc2-a1cf-2d6fd11f2748 21695-363 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA071108 Rebel Distributors Corp FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-365_8bea1481-939d-4bea-a366-0ea435d81288 21695-365 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Rebel Distributors Corp PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-366_01c5574c-1056-49c6-af20-e950db3f4139 21695-366 HUMAN PRESCRIPTION DRUG CRIXIVAN indinavir sulfate CAPSULE ORAL 19960313 NDA NDA020685 Rebel Distributors Corp INDINAVIR SULFATE 400 mg/1 E 20171231 21695-367_166abd26-675e-4832-9d18-0567f2a9d4e4 21695-367 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 19951121 NDA NDA020564 Rebel Distributors Corp LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 21695-368_d2ded29a-448d-4c4a-9307-403836a67da4 21695-368 HUMAN PRESCRIPTION DRUG PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS CONJUNCTIVAL 20100622 NDA NDA200890 Rebel Distributors Corp PILOCARPINE HYDROCHLORIDE 10 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] E 20171231 21695-369_1b34c6ec-ac27-455e-976e-d22cf9d81950 21695-369 HUMAN PRESCRIPTION DRUG Zidovudine ZIDOVUDINE TABLET, FILM COATED ORAL 20090701 ANDA ANDA077267 Rebel Distributors Corp ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 21695-370_1f35ed70-4947-4d4d-b4c8-71ce520fc445 21695-370 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET ORAL 20060329 ANDA ANDA065308 Rebel Distributors Corp CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 21695-371_c1143cd8-4325-4dcf-a12f-8badfdba682f 21695-371 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 Rebel Distributors Corp CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 21695-372_c1143cd8-4325-4dcf-a12f-8badfdba682f 21695-372 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070924 Rebel Distributors Corp CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 21695-373_b581d63f-61cb-41b6-a7ca-24bd0b32a8ae 21695-373 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE, GELATIN COATED ORAL 20020829 NDA NDA021447 Rebel Distributors Corp TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 21695-375_0131d303-52c4-4ea7-a560-b529bb2c1616 21695-375 HUMAN PRESCRIPTION DRUG nizatidine nizatidine CAPSULE ORAL 20020705 ANDA ANDA076178 Rebel Distributors Corp NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 21695-376_23bb4390-7825-4b2c-9dd9-48d2ee90bc6c 21695-376 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080501 NDA NDA020859 Rebel Distributors Corp. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 21695-377_c1143cd8-4325-4dcf-a12f-8badfdba682f 21695-377 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070923 Rebel Distributors Corp CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 21695-378_48b10c63-5d7a-4841-9faa-17ac3d4873d1 21695-378 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Rebel Distributors Corp HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 21695-380_1648670a-5567-4e17-ba8d-84583b7973c5 21695-380 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070813 ANDA ANDA078050 Rebel Distributors Corp. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 21695-382_77a91c9e-f445-4227-8369-c69837563bb9 21695-382 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 Rebel Distributors Corp DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-383_a7839c4b-6e6e-444f-997e-2dbe28a80eaa 21695-383 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 19810603 ANDA ANDA087127 Rebel Distributors Corp. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 21695-384_61b292ba-a739-444d-896e-be204bfd9a1a 21695-384 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20100201 ANDA ANDA061931 Rebel Distributors Corp. AMOXICILLIN 125 mg/5mL E 20171231 21695-385_61b292ba-a739-444d-896e-be204bfd9a1a 21695-385 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20100201 ANDA ANDA061931 Rebel Distributors Corp. AMOXICILLIN 250 mg/5mL E 20171231 21695-386_5dad6fbc-2e4d-49dc-8810-721a7701f01e 21695-386 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 21695-387_e83ebf1a-2719-4f52-a47d-3d5af9e8d6f4 21695-387 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN Base Filmtab ERYTHROMYCIN TABLET, FILM COATED ORAL 19720711 ANDA ANDA061621 Rebel Distributors Corp ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 21695-388_b61c6a09-7764-4a92-93a9-a1356aeeaa9c 21695-388 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20091106 ANDA ANDA076453 Rebel Distributors Corp LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 21695-389_e83ebf1a-2719-4f52-a47d-3d5af9e8d6f4 21695-389 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN Base Filmtab ERYTHROMYCIN TABLET, FILM COATED ORAL 19720711 ANDA ANDA061621 Rebel Distributors Corp ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 21695-393_0a0aff51-3b61-4cde-a415-0694afec99eb 21695-393 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20100226 ANDA ANDA077690 Rebel Distributors Corp QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 21695-394_0a0aff51-3b61-4cde-a415-0694afec99eb 21695-394 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20100226 ANDA ANDA077690 Rebel Distributors Corp QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 21695-397_6383dc39-15a9-4260-8064-18a8c83004b1 21695-397 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20000501 ANDA ANDA075366 Rebel Distributors Corp SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] E 20171231 21695-399_50630775-7f76-413e-9278-ba298dd7f187 21695-399 HUMAN PRESCRIPTION DRUG Zyvox linezolid TABLET, FILM COATED ORAL 20000418 NDA NDA021130 Rebel Distributors Corp LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] E 20171231 21695-400_5858f7b7-5351-4b38-9850-f5b285dcd6e7 21695-400 HUMAN OTC DRUG Double Antibiotic Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B Rebel Distributors Corp BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 1000 [USP'U]/g; [USP'U]/g E 20171231 21695-401_b58ec5f9-0715-4562-9aeb-915329a4eef8 21695-401 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20070813 ANDA ANDA065358 Rebel Distributors Corp. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 21695-403_a5391476-8480-401d-8bb5-0726d8195770 21695-403 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Rebel Distributors Corp DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 21695-404_a5391476-8480-401d-8bb5-0726d8195770 21695-404 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Rebel Distributors Corp DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 21695-406_876466eb-2e9d-4025-ba4f-359174181986 21695-406 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 Rebel Distributors Corp. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 21695-407_69e66f08-be0b-4120-9a30-333b34ad3507 21695-407 HUMAN PRESCRIPTION DRUG TriNessa Norgestimate and Ethinyl Estradiol KIT 20070817 NDA NDA019697 Rebel Distributors Corp E 20171231 21695-408_dfd30506-59e5-4578-879e-fbd6fdd90515 21695-408 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19921105 ANDA ANDA073186 Rebel Distributors Corp DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 21695-410_dfd30506-59e5-4578-879e-fbd6fdd90515 21695-410 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19921105 ANDA ANDA072838 Rebel Distributors Corp DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 21695-411_313ca4f1-7c05-4c8e-b5dd-69eef717bc3c 21695-411 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET ORAL 20030819 ANDA ANDA076794 Rebel Distributors Corp CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-413_284a3c3d-170c-47af-8880-3273d9fb3872 21695-413 VACCINE Tetanus and Diphtheria Toxoids Adsorbed Tetanus and Diphtheria Toxoids Adsorbed INJECTION INTRAMUSCULAR 19671013 BLA BLA101322 Rebel Distributors CLOSTRIDIUM TETANI; CORYNEBACTERIUM DIPHTHERIAE 2; 2 1/.5mL; 1/.5mL E 20171231 21695-415_2d821387-4b4f-4fe3-825e-750f49755baf 21695-415 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20100407 ANDA ANDA089685 Rebel Distributors Corp PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 21695-416_5dda7621-5438-4522-8be0-bc2e8dc418c5 21695-416 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19880818 NDA NDA050592 Rebel Distributors Corp TOBRAMYCIN; DEXAMETHASONE 3; 1 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-417_4067a52d-c3fa-4531-8e4f-9675e494065f 21695-417 HUMAN PRESCRIPTION DRUG VALPROIC ACID valproic acid CAPSULE, LIQUID FILLED ORAL 19930629 ANDA ANDA073484 Rebel Distributors Corp VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 21695-418_432287dc-6d16-4a64-bc5f-ec1327104f7e 21695-418 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET ORAL 20100128 ANDA ANDA064013 Rebel Distributors Corp. AMOXICILLIN 250 mg/1 E 20171231 21695-420_07f01136-4649-4c5d-93c5-a8a7dbced9a1 21695-420 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20040923 ANDA ANDA076925 Rebel Distributors Corp IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-421_b7aa9721-3d25-417f-a88d-b8b740819487 21695-421 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 19960901 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV E 20171231 21695-422_19df63de-9f44-40ce-9a4f-0c96345b8a23 21695-422 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION INTRAVENOUS 20060828 ANDA ANDA077782 Rebel Distributors Corp CIPROFLOXACIN 10 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-423_537a2996-2607-4ad1-9ce3-36dd8a3f5dfb 21695-423 HUMAN PRESCRIPTION DRUG VENTOLINHFA HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 Rebel Distributors Corp. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 21695-424_6e8f9e57-8376-4ce5-8ef0-50b3dd3e1168 21695-424 HUMAN PRESCRIPTION DRUG Sterile Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065397 Rebel Distributors Corp VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 21695-425_0d527c1c-19c5-4199-a51d-b953798d42a3 21695-425 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 19971224 NDA NDA020607 Rebel Distributors Corp. DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 21695-427_b757af04-e516-4ac7-8a2f-45fffab86c5d 21695-427 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20060207 ANDA ANDA065311 Rebel Distributors Corp CEFADROXIL 500 mg/1 E 20171231 21695-428_f3127fff-2943-424d-8b8b-80aa320a2d07 21695-428 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880524 ANDA ANDA072100 Rebel Distributors Corp DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 21695-432_5914ef00-19b1-4e22-9ad3-2b62b455af9d 21695-432 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 Rebel Distributors Corp KETOROLAC TROMETHAMINE 10 mg/1 E 20171231 21695-433_a6cc08b8-146e-430f-af39-8b866698b997 21695-433 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Rebel Distributors Corp CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-434_a6cc08b8-146e-430f-af39-8b866698b997 21695-434 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Rebel Distributors Corp CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-436_6c268aa1-7777-4065-8fe2-b2dd0d2cbab8 21695-436 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090612 ANDA ANDA040754 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 650 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 21695-437_5d57a327-4bdf-4aaa-88f3-e6754665f330 21695-437 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Rebel Distributors Corp NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-438_595ee3ac-2f33-4459-87ff-be002928059c 21695-438 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Rebel Distributors Corp HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 21695-439_7bfa54ff-9a72-45e1-8fe5-e8411f8c6e71 21695-439 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076622 Rebel Distributors Corp OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-440_5b4c09e6-4228-47d5-b8f2-5959f8aede38 21695-440 HUMAN OTC DRUG Banalg Methyl Salicylate LOTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part348 Rebel Distributors Corp METHYL SALICYLATE; MENTHOL 140; 30 mg/g; mg/g E 20171231 21695-441_f6ffd0d8-3451-425e-921e-faae1c1b8ad3 21695-441 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070789 Rebel Distributors Corp DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 21695-442_44c85649-a82e-4c1e-bf3d-b168296d8d0e 21695-442 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20091105 UNAPPROVED DRUG OTHER Rebel Distributors Corp HYOSCYAMINE SULFATE .125 mg/1 E 20171231 21695-443_42e3227a-73eb-4873-99c9-b2edb195027d 21695-443 HUMAN PRESCRIPTION DRUG NEXT CHOICE Levonorgestrel TABLET ORAL 20090721 ANDA ANDA078666 Rebel Distributors Corp. LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] E 20171231 21695-444_c61229e8-75cb-4776-9883-c5630bc38a32 21695-444 HUMAN PRESCRIPTION DRUG Zmax azithromycin POWDER, FOR SUSPENSION ORAL 19950610 NDA NDA050797 Rebel Distributors Corp AZITHROMYCIN 2 g/60mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 21695-446_a2368fd3-124e-476d-a8db-9c45e7423562 21695-446 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 Rebel Distributors Corp. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 21695-448_c6a941a0-67dd-4c2a-accd-3a4578bc409c 21695-448 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide CAPSULE ORAL 20030828 ANDA ANDA076570 Rebel Distributors Corp. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 21695-449_66091ee0-343a-4a04-a61e-86449943bc36 21695-449 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride TABLET ORAL 20031229 ANDA ANDA076392 Rebel Distributors Corp MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] E 20171231 21695-450_dcb552c1-310a-48af-81ad-a74530531dee 21695-450 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Rebel Distributors Corp NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 21695-453_23a83c87-ad92-46af-aeed-12e93ab3255d 21695-453 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 21695-454_430b8bbe-96e2-4300-af13-a0704ac11076 21695-454 HUMAN PRESCRIPTION DRUG ERTACZO ERTACZO CREAM TOPICAL 20031210 ANDA ANDA021385 Rebel Distributors Corp. SERTACONAZOLE NITRATE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] E 20171231 21695-455_8de6a6eb-9ed8-4e05-9a4c-d657b5634f76 21695-455 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20061219 NDA NDA021999 Rebel Distributors Corp PALIPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] E 20171231 21695-457_e142a363-a8b8-40b9-ae9d-28777367e718 21695-457 HUMAN PRESCRIPTION DRUG ERY-TAB erythromycin TABLET, DELAYED RELEASE ORAL 19720711 ANDA ANDA061621 Rebel Distributors Corp ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 21695-458_3d4be22b-7a8c-4247-ac35-143611342de1 21695-458 HUMAN PRESCRIPTION DRUG Tobrex tobramycin OINTMENT OPHTHALMIC 19811125 NDA NDA050555 Rebel Distributors Corp TOBRAMYCIN 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 21695-459_0b5b9f06-15fc-432d-a891-8d91bf80f2d4 21695-459 HUMAN PRESCRIPTION DRUG Oxistat oxiconazole nitrate LOTION TOPICAL 20060125 NDA NDA020209 Rebel Distributors Corp. OXICONAZOLE NITRATE 30 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] E 20171231 21695-461_2db62c07-21be-4378-82fc-a1bd9dc6e3ba 21695-461 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET ORAL 20091209 ANDA ANDA076502 Rebel Distributors Corp FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 21695-462_2db62c07-21be-4378-82fc-a1bd9dc6e3ba 21695-462 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET ORAL 20091209 ANDA ANDA076502 Rebel Distributors Corp FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 21695-463_8014fa52-6180-4365-8285-0943a036a6f6 21695-463 HUMAN PRESCRIPTION DRUG ACULAR KETOROLAC TROMETHAMINE SOLUTION OPHTHALMIC 19921109 NDA NDA019700 Rebel Distributors Corp. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 21695-464_a23a1cca-bc3e-48c5-abd9-82eddb52e91b 21695-464 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Rebel Distributors Corp LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-466_57964c72-5ffe-4548-bca0-a5b0ca57ecb1 21695-466 HUMAN PRESCRIPTION DRUG XYLOCAINE Lidocaine Hydrochloride INJECTION INFILTRATION 19481119 NDA NDA006488 Rebel Distributors Corp LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 21695-467_60cc988d-4175-4d7b-9021-299c46602a4c 21695-467 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 Rebel Distributors Corp GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 21695-468_60cc988d-4175-4d7b-9021-299c46602a4c 21695-468 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 Rebel Distributors Corp GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 21695-469_e253ec37-78bb-4168-b630-2b7e33607f9d 21695-469 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Rebel Distributors Corp GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 21695-470_e253ec37-78bb-4168-b630-2b7e33607f9d 21695-470 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Rebel Distributors Corp GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 21695-471_495738b9-2511-446b-833c-164c0119035b 21695-471 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Rebel Distributors Corp. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 21695-472_495738b9-2511-446b-833c-164c0119035b 21695-472 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Rebel Distributors Corp. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 21695-473_495738b9-2511-446b-833c-164c0119035b 21695-473 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Rebel Distributors Corp. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 21695-474_c119ed19-5dc6-4c03-b705-2616c65ef041 21695-474 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 NDA NDA020406 Rebel Distributors Corp LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 21695-475_70429bdd-af83-4345-99d5-54fde6f28e5e 21695-475 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20070918 ANDA ANDA078270 Rebel Distributors Corp. CICLOPIROX 71.3 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] E 20171231 21695-477_1893cb9f-bdae-4e17-ac6d-8bef66010d7a 21695-477 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Rebel Distributors Corp CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 21695-478_1893cb9f-bdae-4e17-ac6d-8bef66010d7a 21695-478 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Rebel Distributors Corp CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 21695-483_df79a35c-ce5c-452e-b81e-50a014fc94f4 21695-483 HUMAN PRESCRIPTION DRUG clobetasol propionate clobetasol propionate OINTMENT TOPICAL 19960223 ANDA ANDA074407 Rebel Distributors Corp CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-484_6c692344-4d84-4c92-a917-91e02af1a6c3 21695-484 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20070711 ANDA ANDA077621 Rebel Distributors Corp.. AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] E 20171231 21695-485_f32d6e27-5b7b-4b17-af2e-0250447ee560 21695-485 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20080101 ANDA ANDA072750 Rebel Distributors Corp. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 21695-486_16ea7eee-51c9-4305-9808-358e3ace31bd 21695-486 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 Rebel Distributors Corp HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] E 20171231 21695-487_53ac99fe-8ff3-4a6f-b90e-d602e1019acb 21695-487 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Rebel Distributors Corp ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 21695-488_53ac99fe-8ff3-4a6f-b90e-d602e1019acb 21695-488 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Rebel Distributors Corp ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 21695-489_53ac99fe-8ff3-4a6f-b90e-d602e1019acb 21695-489 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Rebel Distributors Corp ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 21695-490_b116f624-85d5-472a-8209-c80eae8204a6 21695-490 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060918 ANDA ANDA078010 Rebel Distirbutors Corp FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 21695-491_b116f624-85d5-472a-8209-c80eae8204a6 21695-491 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060918 ANDA ANDA078010 Rebel Distirbutors Corp FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 21695-494_8ff18a70-965a-4d3e-ae3e-b599c4e6763c 21695-494 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Rebel Distributors Corp. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-496_1061baaf-53f8-4a92-b90f-bcecdf1d183e 21695-496 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19880617 ANDA ANDA072011 Rebel Distributors Corp TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-497_1061baaf-53f8-4a92-b90f-bcecdf1d183e 21695-497 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19920430 ANDA ANDA073281 Rebel Distributors Corp TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-498_32f9efb1-3ab9-4d3c-a3b3-fd94874bea98 21695-498 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Rebel Distributors Corp LORATADINE 5 mg/5mL E 20171231 21695-499_0cc678d4-5bef-4802-921a-523ba1e617eb 21695-499 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20100121 UNAPPROVED DRUG OTHER Rebel Distributors Corp LORATADINE 10 mg/1 E 20171231 21695-500_c46e1443-dffe-47a9-bc9a-acbe3a8b0b41 21695-500 HUMAN OTC DRUG Diphenhydramine Diphenhydramine CAPSULE ORAL 20070101 OTC MONOGRAPH NOT FINAL part348 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 21695-501_063728a5-87b5-4b53-957a-d8e497fcf8b0 21695-501 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-502_063728a5-87b5-4b53-957a-d8e497fcf8b0 21695-502 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-503_3f33ae63-5653-4a75-9f74-19d40ae20209 21695-503 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide OINTMENT TOPICAL 20091007 ANDA ANDA085691 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-504_3f33ae63-5653-4a75-9f74-19d40ae20209 21695-504 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide OINTMENT TOPICAL 20091007 ANDA ANDA085691 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-506_c25ff551-9b15-4348-8d8b-9aeafe264d16 21695-506 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Rebel Distributors Corp. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 21695-507_c25ff551-9b15-4348-8d8b-9aeafe264d16 21695-507 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Rebel Distributors Corp. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 21695-508_c326aa5c-cf35-4c87-9ed2-502bf9babb90 21695-508 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20030528 ANDA ANDA040495 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 660 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 21695-509_42a2586d-b025-4a42-83a3-747a880ed858 21695-509 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE ORAL 19991108 ANDA ANDA040886 Rebel Distributors Corp PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 21695-510_7f871c5e-02e5-40f3-a60d-c9d2e9f5ce66 21695-510 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 19830203 ANDA ANDA087022 Rebel Distributors Corp PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 21695-511_90841684-4f00-450f-b366-6fc914ca8c54 21695-511 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET ORAL 19950424 ANDA ANDA070855 Rebel Distributors Corp VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 21695-512_90841684-4f00-450f-b366-6fc914ca8c54 21695-512 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET ORAL 19960205 ANDA ANDA070856 Rebel Distributors Corp VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 21695-513_29fce92f-babc-45f6-bc50-f3eb5ce7d9fb 21695-513 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040527 Rebel Distributors Corp. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 21695-515_6795ade9-e06e-4daa-bb45-821901a055f5 21695-515 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Buprenorphine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100712 ANDA ANDA074137 Rebel Distributors Corp BUPRENORPHINE HYDROCHLORIDE .3 mg/mL Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII E 20171231 21695-516_ae1e0d8a-03fc-419b-9d44-afa68fbd5681 21695-516 HUMAN PRESCRIPTION DRUG ULORIC febuxostat TABLET ORAL 20090213 NDA NDA021856 Rebel Distributors Corp FEBUXOSTAT 80 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 21695-517_4abb0813-e080-4bae-b829-e2c29d0a8d4f 21695-517 HUMAN OTC DRUG Delsym Dextromethorphan Polistirex SYRUP ORAL 20090904 NDA NDA018658 Rebel Distributors Corp DEXTROMETHORPHAN 30 mg/5mL E 20171231 21695-518_4abb0813-e080-4bae-b829-e2c29d0a8d4f 21695-518 HUMAN OTC DRUG Delsym Dextromethorphan Polistirex SYRUP ORAL 20090904 NDA NDA018658 Rebel Distributors Corp DEXTROMETHORPHAN 30 mg/5mL E 20171231 21695-519_a23a1cca-bc3e-48c5-abd9-82eddb52e91b 21695-519 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Rebel Distributors Corp LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-520_f1f62485-4f0a-4f7e-b450-62f9ce20f13f 21695-520 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20091112 ANDA ANDA074131 Rebel Distributors Corp PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-521_7ca6552c-bd9f-4630-b202-38dea8b7d994 21695-521 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19840226 ANDA ANDA019137 Rebel Distributors Corp. BETAMETHASONE DIPROPIONATE .64 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-522_622ac159-4d19-4c4a-95e2-c3757abf5102 21695-522 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Rebel Distributors Corp INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-523_4755e174-f5d7-451a-9649-46222a6dfced 21695-523 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 19860212 ANDA ANDA070756 Rebel Distributors Corp INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-524_c40df8f6-8374-4f9b-bfce-94d582470d48 21695-524 HUMAN OTC DRUG Phenylephrine Phenylephrine TABLET ORAL 20100224 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 E 20171231 21695-525_f43da9e1-1ed7-48e6-b6f4-4794ba0644a1 21695-525 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SOLUTION OPHTHALMIC 19881018 ANDA ANDA089560 Rebel Distributors Corp SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 21695-526_31fe1e75-da67-4e6d-a529-8b82905dad45 21695-526 HUMAN PRESCRIPTION DRUG Vivotif-B Vivotif-B CAPSULE ORAL 19891215 BLA BLA103123 Rebel Distributors Corp SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 2 [CFU]/1 E 20171231 21695-527_fe7adfbd-d1dc-4d50-80bc-0cc826a64d86 21695-527 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 19970528 ANDA ANDA064150 Rebel Distributors Corp RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 21695-528_65edc059-0806-4625-b583-0e36f04cf085 21695-528 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Gramicidin Neomycin sulfate, Polymyxin B Sulfate and Gramicidin SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064047 Rebel Distributors Corp NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN 1.75; 10000; .025 mg/mL; mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 21695-529_dd34a5ef-f24d-4e02-a78e-f8b93eae384d 21695-529 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19760430 ANDA ANDA080693 Rebel Distributors Corp HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-530_c1e57227-6c96-4922-973e-74838ab4c795 21695-530 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION OPHTHALMIC 19950929 ANDA ANDA040074 Rebel Distributors Corp PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] E 20171231 21695-534_347c802f-4ea9-41d4-80d6-e4a183f22179 21695-534 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Rebel Distributors Corp LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-535_347c802f-4ea9-41d4-80d6-e4a183f22179 21695-535 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Rebel Distributors Corp LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-536_347c802f-4ea9-41d4-80d6-e4a183f22179 21695-536 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Rebel Distributors Corp LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-537_e66b1c3c-9121-4e2a-a8c8-65b2e8c54f52 21695-537 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070227 ANDA ANDA040707 Rebel Distributors Corp HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-538_256bfee6-3e21-4fdb-a1d0-0ef417b8be86 21695-538 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20060801 ANDA ANDA084878 Rebel Distributors Corp HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-539_256bfee6-3e21-4fdb-a1d0-0ef417b8be86 21695-539 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19770201 ANDA ANDA084878 Rebel Distributors Corp HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-544_ee3875c6-5c49-4386-8ad2-5fe3208ed9e9 21695-544 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20050713 ANDA ANDA065228 Rebel Distributors Corp. AMOXICILLIN 875 mg/1 E 20171231 21695-546_d74e93e5-11c9-434e-a60c-4a4f911dd0f8 21695-546 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20020605 ANDA ANDA065066 Rebel Distributors Corp. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 21695-547_2f92c67b-f324-4c4e-89fd-1e0f8af96fba 21695-547 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 19810821 ANDA ANDA087508 Rebel Distributors Corp. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL CV E 20171231 21695-548_72cd7af3-24c4-4a06-b079-ba47d07d7253 21695-548 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin monohydrate POWDER, FOR SUSPENSION ORAL 20080624 ANDA ANDA065419 Rebel Distributors Corp. AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 21695-549_72cd7af3-24c4-4a06-b079-ba47d07d7253 21695-549 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin monohydrate POWDER, FOR SUSPENSION ORAL 20080624 ANDA ANDA065419 Rebel Distributors Corp. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 21695-551_4e334e50-19c4-449b-b77f-549a461c7f84 21695-551 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20100921 ANDA ANDA062703 Rebel Distributors Corp CEPHALEXIN 250 mg/5mL E 20171231 21695-554_836ebf14-fb11-45c3-9e0c-db1bebcd0f5b 21695-554 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 Rebel Distributors Corp KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 21695-555_836ebf14-fb11-45c3-9e0c-db1bebcd0f5b 21695-555 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 Rebel Distributors Corp KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 21695-556_836ebf14-fb11-45c3-9e0c-db1bebcd0f5b 21695-556 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 Rebel Distributors Corp KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 21695-557_f3a50f13-b028-4135-8f20-bfb62a9bc0a9 21695-557 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20051018 ANDA ANDA065144 Rebel Distributors Corp. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 21695-558_f3a50f13-b028-4135-8f20-bfb62a9bc0a9 21695-558 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20050825 ANDA ANDA065136 Rebel Distributors Corp. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 21695-559_d291f309-1a61-4e32-a684-5b32e7bcb518 21695-559 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19680731 ANDA ANDA060456 Rebel Distributors Corp PENICILLIN V POTASSIUM 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 21695-560_8e80f9d8-2577-4fd9-a455-e6c6dc244c3a 21695-560 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Rebel Distributors Corp FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 21695-561_b6ccbb82-3804-4f02-bf17-f07e22a8b02a 21695-561 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride TABLET ORAL 20100421 ANDA ANDA077699 Rebel Distributors Corp MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] E 20171231 21695-562_ec308fcf-ec39-43af-97e3-98aa8ab997f4 21695-562 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075319 Rebel Distributors Corp KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 21695-563_2fd193e2-7aa7-4119-b540-7e28e82fbd13 21695-563 HUMAN PRESCRIPTION DRUG ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20050908 NDA NDA021692 Rebel Distributors Corp TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 21695-564_c74c9424-278d-4a52-8866-db66f6c3ac67 21695-564 HUMAN PRESCRIPTION DRUG Amantadine HCl Amantadine hydrochloride CAPSULE ORAL 20081101 ANDA ANDA078720 Rebel Distributors Corp. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] E 20171231 21695-565_78eea56d-15a6-4ceb-b755-d1a3e9707f32 21695-565 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Rebel Distributors Corp MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 21695-566_da73cc74-908f-4497-8770-6c1d774f5ce2 21695-566 HUMAN OTC DRUG Clearlax polyethylene glycol POWDER, FOR SOLUTION TOPICAL 20091007 ANDA ANDA090685 Rebel Distributors Corp POLYETHYLENE GLYCOL 3350 17 g/1 E 20171231 21695-567_f4ac82b0-d0fb-4720-a277-5b2b8013cb3f 21695-567 HUMAN PRESCRIPTION DRUG Catapres clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 19851001 NDA NDA018891 Rebel Distributors Corp CLONIDINE .1 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 21695-568_6f90218a-1595-4af4-97cb-859b265babf4 21695-568 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20100122 ANDA ANDA076345 Rebel Distributors Corp GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 21695-569_48945996-e8b9-462f-b454-3b11fd844a6d 21695-569 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 19880504 ANDA ANDA089895 Rebel Distributors Corp CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 21695-570_e4c5e195-e3f1-487a-accd-c2c6fbbd7837 21695-570 HUMAN PRESCRIPTION DRUG Carisoprodol and Aspirin Carisoprodol and Aspirin TABLET ORAL 20091001 ANDA ANDA040116 Rebel Distributors Corp CARISOPRODOL; ASPIRIN 200; 325 mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE] E 20171231 21695-571_a49905cc-dd53-43a2-8113-d8ada3f8cae9 21695-571 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 19980301 ANDA ANDA040268 Rebel Distributors Corp PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 21695-572_a49905cc-dd53-43a2-8113-d8ada3f8cae9 21695-572 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 19980301 ANDA ANDA040268 Rebel Distributors Corp PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 21695-573_92b5435b-eab1-4e4e-a689-18dbc84b9984 21695-573 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Rebel Distributors Corp HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 21695-575_f3516a1d-6f30-42b5-9a7a-07ccff7c58d6 21695-575 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Rebel Distributors Corp ISOSORBIDE MONONITRATE 30 mg/1 E 20171231 21695-576_92c7be7d-8c89-476a-b131-9deef76ed016 21695-576 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20100118 ANDA ANDA074461 Rebel Distributors Corp INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 21695-578_22009d23-999c-4fa6-bfe7-21395f577236 21695-578 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070613 ANDA ANDA077715 Rebel Distributors Corp BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 21695-579_029f39ed-ec6f-4fdc-bc0d-abfb6784cc91 21695-579 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960229 ANDA ANDA040144 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 21695-580_5092299c-3782-4ee5-b3e7-4e80bf378e3b 21695-580 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087800 Rebel Distributors Corp PREDNISONE 1 mg/1 E 20171231 21695-581_3f5f2d28-1053-44dd-8f9a-12bcc1172488 21695-581 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline Hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 Rebel Distributors Corp. DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 21695-584_f242cdf5-6921-431f-8add-4d17887ebc93 21695-584 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate CREAM TOPICAL 19850514 ANDA ANDA070062 Rebel Distributors Corp. BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-585_21618014-77c1-4a35-acca-cd5678d7bb89 21695-585 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20100331 ANDA ANDA040445 Rebel Distributors Corp. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 21695-586_eeb337ba-0d7e-42cd-840a-78783b5688d7 21695-586 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate OINTMENT TOPICAL 20091023 ANDA ANDA018865 Rebel Distributors Corp BETAMETHASONE VALERATE 1 mg/g E 20171231 21695-588_31da4540-1589-492c-8be6-382179e8ece2 21695-588 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19990127 ANDA ANDA074993 Rebel Distributors Corp KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 21695-589_65b2f396-666b-4b08-890f-19429844e74b 21695-589 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 21695-590_7e23b026-fee4-436a-b378-33d31d6d8b40 21695-590 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20070101 OTC MONOGRAPH NOT FINAL part334 Rebel Distributors Corp DOCUSATE SODIUM 100 mg/1 E 20171231 21695-591_ea6968e3-6383-4ff1-8c81-e4a2fdfe749d 21695-591 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide TABLET, FILM COATED ORAL 20010228 NDA NDA021169 Rebel Distributors Corp GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 21695-592_7cdbf66c-9548-47ac-b79a-10a9934c1a29 21695-592 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Rebel Distributors Corp LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-594_4de8df82-23db-421b-8531-c755854b3e5e 21695-594 HUMAN PRESCRIPTION DRUG RE-PB HYOS ELIXIR BELLADONNA ALKALOIDS W/ PHENOBARBITAL ELIXIR ORAL 20091020 UNAPPROVED DRUG OTHER Rebel Distributors Corp PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] CIV E 20171231 21695-595_8060a686-f1e1-4171-9b99-28791e502bdb 21695-595 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone neomycin sulfate, polymyxin B sulfate and dexamethasone SUSPENSION OPHTHALMIC 19861117 ANDA ANDA062721 Rebel Distributors Corp NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-597_f31c768e-4156-4ebe-8dce-763bf940ab1b 21695-597 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20090601 ANDA ANDA085588 Rebel Distributors Corp PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII E 20171231 21695-598_7546518f-b90f-477f-8f94-9ed76f98f1d7 21695-598 HUMAN OTC DRUG Polyethylene Glycol 3350, NF Powder for Solution, Laxative Polyethylene Glycol 3350, NF Powder for Solution, Laxative POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090812 Rebel Distributors Corp POLYETHYLENE GLYCOL 3350 17 g/g E 20171231 21695-599_03601ccc-4a9a-4cb9-9028-281bbed42182 21695-599 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920330 ANDA ANDA073555 Rebel Distributors Corp NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 21695-600_03601ccc-4a9a-4cb9-9028-281bbed42182 21695-600 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920330 ANDA ANDA073556 Rebel Distributors Corp NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 21695-601_f168b0a9-4e9a-47f7-b391-edcea871956e 21695-601 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET ORAL 20060331 ANDA ANDA077248 Rebel Distributors Corp PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] E 20171231 21695-602_1f1c17ab-5bfb-4084-a89e-f0c71a04dfbc 21695-602 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Rebel Distributors Corp. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 21695-603_1f1c17ab-5bfb-4084-a89e-f0c71a04dfbc 21695-603 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Rebel Distributors Corp. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 21695-604_1f1c17ab-5bfb-4084-a89e-f0c71a04dfbc 21695-604 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Rebel Distributors Corp. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 21695-605_1f1c17ab-5bfb-4084-a89e-f0c71a04dfbc 21695-605 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Rebel Distributors Corp. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 21695-606_6543c6ba-852e-40fb-b7ec-1331b9c83656 21695-606 HUMAN PRESCRIPTION DRUG Soma Carisoprodol TABLET ORAL 20070901 NDA NDA011792 Rebel Distributors Corp CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 21695-612_56ffd662-60a6-4b43-a7ea-f778714dfbbd 21695-612 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Rebel Distributors Corp. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 21695-613_c674e1bc-5c8e-4c59-8de5-c7fa5306706d 21695-613 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Rebel Distributors Corp ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 21695-614_389cdebb-55fe-4808-a5b7-0f293d9ee45d 21695-614 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 19870203 ANDA ANDA071012 Rebel Distributors Corp. BETAMETHASONE DIPROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-615_725fb4ac-3bd2-4c0f-829f-a3a40863ebce 21695-615 HUMAN PRESCRIPTION DRUG Flurbiprofen Sodium Flurbiprofen Sodium SOLUTION/ DROPS OPHTHALMIC 19950104 ANDA ANDA074447 Rebel Distributors Corp FLURBIPROFEN SODIUM .242 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-616_b53ab2b3-f8f6-4799-8a8e-221302d975c8 21695-616 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 19960730 ANDA ANDA040105 Rebel Distributors Corp OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 21695-617_d8b466e0-a35e-4fba-9d43-4e6c0122e7ad 21695-617 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE ORAL 20101013 ANDA ANDA075576 Rebel Distributors Corp OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 21695-619_0d0dbb74-4a2c-4a95-b81e-6d008cd88808 21695-619 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040778 Rebel Distributors Corp OXYCODONE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 21695-620_a84712bf-221d-4366-9cf0-b8c19428c276 21695-620 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107 ANDA ANDA065434 Rebel Distributors Corp CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 21695-622_a9c339ac-14a5-465e-a4fe-1d361d017ccf 21695-622 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 Rebel Distributors Corp CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 21695-623_c674e1bc-5c8e-4c59-8de5-c7fa5306706d 21695-623 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Rebel Distributors Corp ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 21695-624_947e29c2-a270-48e0-ba96-c7ed676db871 21695-624 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078399 Rebel Distributors Corp KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 21695-627_31f5280d-bed3-4be9-9e03-6d51cf6d9582 21695-627 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19810714 ANDA ANDA087425 Rebel Distributors Corp ISONIAZID 300 mg/1 Antimycobacterial [EPC] E 20171231 21695-628_fe08bcd5-4d14-4c2d-940c-b7968f9a89f0 21695-628 HUMAN PRESCRIPTION DRUG TobraDex tobramycin and dexamethasone OINTMENT OPHTHALMIC 19880928 NDA NDA050616 Rebel Distributors Corp TOBRAMYCIN; DEXAMETHASONE 3; 1 mg/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-630_dfb8fc2d-4899-4891-a985-755fbdf1d525 21695-630 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20070702 ANDA ANDA077533 Rebel Distributors Corp TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] E 20171231 21695-633_f990eca6-fe6f-4423-a118-4b7b970995a1 21695-633 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Rebel Distributors Corp VARENICLINE TARTRATE .5 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] E 20171231 21695-634_fbb6a064-59a6-4e1c-bbb6-5934c1505c4f 21695-634 HUMAN PRESCRIPTION DRUG Pentazocine HCl and Acetaminophen Pentazocine Hydrochloride and Acetaminophen TABLET ORAL 20000324 ANDA ANDA074699 Rebel Distributors Corp PENTAZOCINE HYDROCHLORIDE; ACETAMINOPHEN 25; 650 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV E 20171231 21695-635_bd2f4e87-e595-4099-acb9-e36803170f72 21695-635 HUMAN PRESCRIPTION DRUG Nitroglycerin Slocaps Nitroglycerin Sustained-release capsules CAPSULE ORAL 19820825 UNAPPROVED DRUG OTHER Rebel Distributors Corp NITROGLYCERIN 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 21695-636_bd2f4e87-e595-4099-acb9-e36803170f72 21695-636 HUMAN PRESCRIPTION DRUG Nitroglycerin Slocaps Nitroglycerin Sustained-release capsules CAPSULE ORAL 19820825 UNAPPROVED DRUG OTHER Rebel Distributors Corp NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 21695-639_39fd1b7e-fac0-4d6f-8bc2-4af6e880a53d 21695-639 HUMAN OTC DRUG Peptic Relief Peptic Relief TABLET ORAL 20111230 OTC MONOGRAPH FINAL part335 Rebel Distributors Corp BISMUTH SUBSALICYLATE 262 mg/1 E 20171231 21695-640_5419f5dd-bf20-4eea-982d-33511a022c38 21695-640 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100323 ANDA ANDA060704 Rebel Distributors Corp TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 21695-641_ea6fac20-4c6b-42bb-8efd-c43458564fe7 21695-641 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE TOPICAL 20100707 ANDA ANDA040771 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-642_79dd238d-87fe-4d89-bb3f-2677cae25993 21695-642 HUMAN OTC DRUG Flexall Pain Relieving Menthol GEL TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part348 Rebel Distributors Corp MENTHOL .16 g/g E 20171231 21695-643_29ccf947-91c1-405a-aba6-5889e3c75d70 21695-643 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20050628 ANDA ANDA065148 Rebel Distributors Corp NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 21695-644_5da8f60f-c809-4161-a802-6fe823d532bb 21695-644 HUMAN PRESCRIPTION DRUG Altabax retapamulin OINTMENT TOPICAL 20100107 NDA NDA022055 Rebel Distributors Corp. RETAPAMULIN 10 mg/g pleuromutilin [Chemical/Ingredient],Pleuromutilin Antibacterial [EPC] E 20171231 21695-649_3087a1cb-fda5-4115-86b6-1cce480a2f8e 21695-649 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20030630 ANDA ANDA040500 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 21695-650_08214b30-3dab-4621-a6c0-6bb68529dee3 21695-650 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Rebel Distributors Corp MILNACIPRAN HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-651_08214b30-3dab-4621-a6c0-6bb68529dee3 21695-651 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Rebel Distributors Corp MILNACIPRAN HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-652_c119ed19-5dc6-4c03-b705-2616c65ef041 21695-652 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 NDA NDA020406 Rebel Distributors Corp LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 21695-653_871fc448-dfa7-492b-813c-c37e93e53cdb 21695-653 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071209 Rebel Distributors Corp HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] E 20171231 21695-654_c9c9efaf-983f-4f72-9099-0957fee5396c 21695-654 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060317 ANDA ANDA077634 Rebel Distributors Corp ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 21695-655_f5ce22e8-1a9b-408c-86ae-4084b7afeca1 21695-655 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 ANDA ANDA075264 Rebel Distributors Corp TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 21695-656_6473563d-b4df-4434-a74e-f8fa3cb9994f 21695-656 HUMAN PRESCRIPTION DRUG Aggrenox aspirin and dipyridamole CAPSULE ORAL 19991219 NDA NDA020884 Rebel Distributors Corp. ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 21695-657_7db112de-473a-4407-bc1c-35d0ab748700 21695-657 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Rebel Distributors Corp DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-659_3bf80420-7482-44c0-a117-30793ba89544 21695-659 HUMAN PRESCRIPTION DRUG Crestor Rosuvastatin calcium TABLET, FILM COATED ORAL 20041101 NDA NDA021366 Rebel Distributors Corp ROSUVASTATIN CALCIUM 40 mg/1 E 20171231 21695-661_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-661 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20050610 NDA NDA021724 Rebel Distributors Corp PREGABALIN 100 mg/1 CV E 20171231 21695-662_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-662 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20050610 NDA NDA021724 Rebel Distributors Corp PREGABALIN 150 mg/1 CV E 20171231 21695-663_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-663 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20050610 NDA NDA021724 Rebel Distributors Corp PREGABALIN 200 mg/1 CV E 20171231 21695-664_8fb45a78-b2d8-45dd-b844-0de21d1fdde9 21695-664 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Rebel Distributors Corp PREGABALIN 300 mg/1 CV E 20171231 21695-665_1086a7b4-b89b-4bee-8120-5f752626c046 21695-665 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 19000101 NDA NDA020839 Rebel Distributors Corp CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 21695-666_3599c90e-4cb0-475e-9d1e-8172c8ce014c 21695-666 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20081107 OTC MONOGRAPH FINAL part343 Rebel Distributors Corp ASPIRIN 325 mg/1 E 20171231 21695-667_d82243b9-3e56-4a2b-8750-cb95ec106885 21695-667 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20090921 ANDA ANDA078635 Rebel Distributors Corp BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-668_9ab4058c-86fa-41c8-8291-e073fd28257f 21695-668 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860101 ANDA ANDA070176 Rebel Distributors Corp PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-669_9ab4058c-86fa-41c8-8291-e073fd28257f 21695-669 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860101 ANDA ANDA070177 Rebel Distributors Corp PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-670_d82243b9-3e56-4a2b-8750-cb95ec106885 21695-670 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20090921 ANDA ANDA078635 Rebel Distributors Corp BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-671_c10e3a16-d94f-442f-9303-4ded0adaecc1 21695-671 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 20091118 ANDA ANDA086831 Rebel Distributors Corp CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 21695-672_e463ea06-12a7-463c-90eb-082d0035b55f 21695-672 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 21695-673_e463ea06-12a7-463c-90eb-082d0035b55f 21695-673 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 21695-674_e463ea06-12a7-463c-90eb-082d0035b55f 21695-674 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 21695-675_e463ea06-12a7-463c-90eb-082d0035b55f 21695-675 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 21695-677_e463ea06-12a7-463c-90eb-082d0035b55f 21695-677 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 21695-679_d0a368ef-a524-4eb4-b984-5ee1d9d5a93d 21695-679 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE Hydralazine Hydrochloride TABLET ORAL 20080912 ANDA ANDA040901 Rebel Distributors Corp HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 21695-680_d0a368ef-a524-4eb4-b984-5ee1d9d5a93d 21695-680 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE Hydralazine Hydrochloride TABLET ORAL 20080912 ANDA ANDA040901 Rebel Distributors Corp HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 21695-681_3f0ec253-6179-4609-8a67-00dbefc55033 21695-681 HUMAN OTC DRUG Mineral Oil Lacri-Lube OINTMENT OPHTHALMIC 20071130 OTC MONOGRAPH FINAL part346 Rebel Distributors Corp MINERAL OIL; PETROLATUM 425; 568 mg/g; mg/g E 20171231 21695-684_ec6b0a04-3fb3-46ab-bca6-1415d2f4e72b 21695-684 HUMAN OTC DRUG Aspirin EC Aspirin TABLET, COATED ORAL 19930101 OTC MONOGRAPH FINAL part343 Rebel Distributors Corp ASPIRIN 81 mg/1 E 20171231 21695-685_3cb9494c-4d70-4ebd-98ec-0e28021c1fee 21695-685 HUMAN PRESCRIPTION DRUG Tilia Fe Norethindrone Acetate and Ethinyl Estradiol KIT 20101201 ANDA ANDA076629 Rebel Distributors Corp E 20171231 21695-688_787f49c7-3726-4eee-87f0-0d6ab8fc5f3c 21695-688 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20091130 ANDA ANDA085762 Rebel Distributors Corp DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV E 20171231 21695-689_717c622c-570e-47d4-be73-041a88e8ebf8 21695-689 HUMAN OTC DRUG Siladryl Allergy Medicine diphenhydramine hydrochloride LIQUID ORAL 19970101 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 21695-690_60d1aea0-f106-4b20-8ef4-7a80e37f8a50 21695-690 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION ORAL 19880520 ANDA ANDA062759 Rebel Distributors Corp ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL 200; 600 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 21695-692_4f359545-2248-4f13-9651-c2aad0153ee6 21695-692 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19920430 ANDA ANDA073192 Rebel Distributors Corp LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] E 20171231 21695-693_a74f9195-8a43-428f-9262-a41313165e0a 21695-693 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20001130 ANDA ANDA065062 Rebel Distributors Corp. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 21695-694_d0a368ef-a524-4eb4-b984-5ee1d9d5a93d 21695-694 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE Hydralazine Hydrochloride TABLET ORAL 20080912 ANDA ANDA040901 Rebel Distributors Corp HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 21695-695_d0a368ef-a524-4eb4-b984-5ee1d9d5a93d 21695-695 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE Hydralazine Hydrochloride TABLET ORAL 20080912 ANDA ANDA040901 Rebel Distributors Corp HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 21695-698_56dfd62c-d386-4e9f-9946-07eda94fa122 21695-698 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Promethazine Hydrochloride and Dextromethorphan Hydrobromide SYRUP ORAL 19850104 ANDA ANDA088864 Rebel Distributors Corp DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 21695-699_f4fdfd83-c078-424b-9b46-d175c8e7f726 21695-699 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20091113 ANDA ANDA078783 Rebel Distributors Corp. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 21695-700_f4fdfd83-c078-424b-9b46-d175c8e7f726 21695-700 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20091113 ANDA ANDA078783 Rebel Distributors Corp. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 21695-701_3e568a2e-421d-4456-a8bf-d983ecee7ad6 21695-701 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19971229 ANDA ANDA074650 Rebel Distributors Corp SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 21695-703_85f183af-6781-4ceb-9c21-c4ee9a06c355 21695-703 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 19821115 ANDA ANDA087953 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 21695-704_155d0f79-86c2-4096-97f3-5d82762ddc2e 21695-704 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20080116 ANDA ANDA077570 Rebel Distributors Corp FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-705_5379a585-584d-45f5-9113-dffc277d5876 21695-705 HUMAN OTC DRUG Cough Guaifenesin LIQUID ORAL 20091204 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp GUAIFENESIN 100 mg/5mL E 20171231 21695-707_3c9f9507-8f72-4850-aa43-9ff5532f1396 21695-707 HUMAN PRESCRIPTION DRUG Flector Diclofenac epolamine PATCH TOPICAL 20081117 NDA NDA021234 Rebel Distributors Corp DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-709_d65cd557-92e1-49b0-9ff5-8479b0ed9f76 21695-709 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077946 Rebel Distributors Corp CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 21695-710_888d7749-bdbc-4788-a215-9c0447aee79a 21695-710 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20071228 ANDA ANDA078792 Rebel Distributors Corp DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-711_aa6d9e02-0ff8-421d-9ddd-8968f41f0af7 21695-711 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 Rebel Distributors Corp POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 21695-712_aa6d9e02-0ff8-421d-9ddd-8968f41f0af7 21695-712 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 Rebel Distributors Corp POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 21695-714_2e1f1640-c6ff-456f-8bec-ec3251065f46 21695-714 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Rebel Distributors Corp LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 21695-715_2016f03e-e7ac-43b6-8244-0389ce057b2b 21695-715 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20090903 ANDA ANDA076690 Rebel Distributors Corp. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-716_2016f03e-e7ac-43b6-8244-0389ce057b2b 21695-716 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20090903 ANDA ANDA076690 Rebel Distributors Corp. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-717_2e1f1640-c6ff-456f-8bec-ec3251065f46 21695-717 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Rebel Distributors Corp LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 21695-719_2016f03e-e7ac-43b6-8244-0389ce057b2b 21695-719 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20090903 ANDA ANDA076690 Rebel Distributors Corp. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-720_2016f03e-e7ac-43b6-8244-0389ce057b2b 21695-720 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20090903 ANDA ANDA076690 Rebel Distributors Corp. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-721_3ec788b9-b851-4022-a3ef-8ec72bc3d258 21695-721 HUMAN PRESCRIPTION DRUG furosemide furosemide INJECTION INTRAMUSCULAR; INTRAVENOUS 19831130 ANDA ANDA018579 Rebel Distributors Corp FUROSEMIDE 10 mg/2mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 21695-722_5b17afd8-de62-4684-b556-d2846eb214b8 21695-722 HUMAN OTC DRUG Senna Plus Senna Plus TABLET ORAL 20090710 OTC MONOGRAPH NOT FINAL part334 Rebel Distributors Corp SENNOSIDES A AND B 8.6 mg/1 E 20171231 21695-723_555ff988-280c-4272-bf1f-a911fe2e584d 21695-723 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071001 NDA NDA021777 Rebel Distributors Corp. CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 21695-724_fc51bad7-8a77-4c0e-9ff8-fa3474796d35 21695-724 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20090701 ANDA ANDA074649 Rebel Distributors Corp CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 21695-725_5d28721d-097f-400e-8690-d133c76e07be 21695-725 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Rebel Distributors Corp ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-726_8e41b33e-f71f-4a5e-b88f-cdfefb2bee20 21695-726 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate, Aspirin and Caffeine Orphenadrine Citrate, Aspirin and Caffeine TABLET, MULTILAYER ORAL 19961231 ANDA ANDA074654 Rebel Distributors Corp ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE 50; 770; 60 mg/1; mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 21695-728_77a91c9e-f445-4227-8369-c69837563bb9 21695-728 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19830915 ANDA ANDA088306 Rebel Distributors Corp DEXAMETHASONE 1 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-729_72335a37-d685-457c-a431-fd81e4ad9168 21695-729 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Rebel Distributors Corp LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 E 20171231 21695-730_be1b30fc-5b34-409e-b396-bc48aefad214 21695-730 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate CREAM TOPICAL 19980825 ANDA ANDA075042 Rebel Distributors Corp HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-732_d709812f-e958-4065-a447-c2c00ddd7677 21695-732 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20101109 ANDA ANDA077836 Rebel Distributors Corp GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 21695-733_63fa5147-fb3e-47ec-bea1-a80e1f551866 21695-733 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Rebel Distributors Corp LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-734_63fa5147-fb3e-47ec-bea1-a80e1f551866 21695-734 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Rebel Distributors Corp LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-735_63fa5147-fb3e-47ec-bea1-a80e1f551866 21695-735 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Rebel Distributors Corp LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-736_bdee074e-e813-4403-897c-1ccb32bd6548 21695-736 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Neomycin sulfate and Polymyxin B Sulfate, Bacitracin zinc and Hydrocortisone Acetate OINTMENT OPHTHALMIC 19810414 ANDA ANDA062166 Rebel Distributors Corp NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE ACETATE 3.5; 10000; 400; 10 mg/g; g/g; g/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-737_a70f8ee5-e9c7-41fa-b45d-69e32cd33cf8 21695-737 HUMAN OTC DRUG Q Tussin DM Dextromethorphan HBr and Guaifenesin SYRUP ORAL 19950401 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 21695-738_364238c7-11b0-442e-acd9-4a6f21b9d783 21695-738 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20090924 ANDA ANDA076685 Rebel Distributors Corp SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-739_364238c7-11b0-442e-acd9-4a6f21b9d783 21695-739 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20070202 ANDA ANDA076685 Rebel Distributors Corp SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-740_364238c7-11b0-442e-acd9-4a6f21b9d783 21695-740 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20080721 ANDA ANDA076685 Rebel Distributors Corp SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-741_364238c7-11b0-442e-acd9-4a6f21b9d783 21695-741 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20080708 ANDA ANDA076685 Rebel Distributors Corp SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-742_364238c7-11b0-442e-acd9-4a6f21b9d783 21695-742 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20070523 ANDA ANDA076685 Rebel Distributors Corp SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-743_cd4f6a14-a2eb-4157-83a7-91ab4e9926e5 21695-743 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Rebel Distributors Corp. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 21695-744_cd4f6a14-a2eb-4157-83a7-91ab4e9926e5 21695-744 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Rebel Distributors Corp. ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 21695-745_77a91c9e-f445-4227-8369-c69837563bb9 21695-745 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19820826 ANDA ANDA087916 Rebel Distributors Corp DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-746_2001c00c-89ba-4d36-b39b-a5374a368427 21695-746 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Rebel Distributors Corp GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 21695-747_2001c00c-89ba-4d36-b39b-a5374a368427 21695-747 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Rebel Distributors Corp GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 21695-748_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-748 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 21695-749_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-749 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 21695-750_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-750 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 21695-751_1f2e9f8f-0662-4fd4-b53c-776b6a395a30 21695-751 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 21695-752_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-752 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 21695-753_1f2e9f8f-0662-4fd4-b53c-776b6a395a30 21695-753 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 21695-754_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-754 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 21695-755_1f2e9f8f-0662-4fd4-b53c-776b6a395a30 21695-755 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021210 Rebel Distributors Corp LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 21695-756_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-756 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 21695-757_1f2e9f8f-0662-4fd4-b53c-776b6a395a30 21695-757 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 21695-758_3d43dfcf-f3b1-48a5-837c-d8010d45e0f0 21695-758 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Rebel Distributors Corp. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 21695-759_3bf80420-7482-44c0-a117-30793ba89544 21695-759 HUMAN PRESCRIPTION DRUG Crestor Rosuvastatin calcium TABLET, FILM COATED ORAL 20050622 NDA NDA021366 Rebel Distributors Corp ROSUVASTATIN CALCIUM 5 mg/1 E 20171231 21695-760_15dd2f41-952b-40d2-a9bb-5e1cb8802e5e 21695-760 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Rebel Distributors Corp BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 21695-761_fb98a6b8-da0c-40f4-9e53-487b541865b5 21695-761 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 19930129 ANDA ANDA064022 Rebel Distributors Corp NYSTATIN 100000 mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 21695-762_29757715-e851-4e9f-b0a9-6fc05dda0205 21695-762 HUMAN OTC DRUG Cepacol Sore Throat Benzocaine and Menthol LOZENGE ORAL 20110804 OTC MONOGRAPH NOT FINAL part356 Rebel Distributors Corp BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 E 20171231 21695-763_f5ce22e8-1a9b-408c-86ae-4084b7afeca1 21695-763 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin GEL TOPICAL 20000222 ANDA ANDA075529 Rebel Distributors Corp TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 21695-764_e99ddb19-8169-4ff4-9e23-16f763e8d7e4 21695-764 HUMAN PRESCRIPTION DRUG Prednisone prednisone TABLET ORAL 20020712 ANDA ANDA040256 Rebel Distributors Corp PREDNISONE 5 mg/1 E 20171231 21695-765_e99ddb19-8169-4ff4-9e23-16f763e8d7e4 21695-765 HUMAN PRESCRIPTION DRUG Prednisone prednisone TABLET ORAL 20020712 ANDA ANDA040256 Rebel Distributors Corp PREDNISONE 10 mg/1 E 20171231 21695-766_90668e5a-0c0d-4941-94cf-8b2fba410ed7 21695-766 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 19860723 ANDA ANDA089424 Rebel Distributors Corp SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 21695-767_2970fe7e-9e1f-47aa-85ad-663ee15c7e06 21695-767 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20020605 ANDA ANDA065066 Rebel Distributors Corp AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 21695-769_e2f5ed4f-dd97-4dda-83d1-f8edd8786c0e 21695-769 HUMAN PRESCRIPTION DRUG Sprintec Norgestimate and Ethinyl Estradiol KIT 20101122 ANDA ANDA075804 Rebel Distributors Corp E 20171231 21695-770_7fd4976d-720c-40ee-8723-a703645d4ff0 21695-770 HUMAN PRESCRIPTION DRUG Tri-Sprintec norgestimate and ethinyl estradiol KIT 20110125 ANDA ANDA075808 Rebel Distributors Corp E 20171231 21695-771_a81dc60e-af42-4d5a-ba21-865fec74ce05 21695-771 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20101012 ANDA ANDA077056 Rebel Distributors Corp PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 21695-772_d291f309-1a61-4e32-a684-5b32e7bcb518 21695-772 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19680731 ANDA ANDA060456 Rebel Distributors Corp PENICILLIN V POTASSIUM 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 21695-773_3d6ce551-6a0a-4d40-8592-cd6d92d55913 21695-773 HUMAN PRESCRIPTION DRUG Xodol Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20040623 ANDA ANDA040658 Rebel Distributors Corp. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 21695-774_3d6ce551-6a0a-4d40-8592-cd6d92d55913 21695-774 HUMAN PRESCRIPTION DRUG Xodol Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20040623 ANDA ANDA040556 Rebel Distributors Corp. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 21695-775_3d6ce551-6a0a-4d40-8592-cd6d92d55913 21695-775 HUMAN PRESCRIPTION DRUG Xodol Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20040623 ANDA ANDA040556 Rebel Distributors Corp. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 21695-777_cc6293ae-1f81-4670-84b2-c00422c690ca 21695-777 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Rebel Distributors Corp ISOSORBIDE MONONITRATE 120 mg/1 E 20171231 21695-778_582e1593-1e6c-4ce8-8bae-134fbc3a66f0 21695-778 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20090727 NDA NDA021445 Rebel Distributors Corp EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] E 20171231 21695-779_fc274f83-4cd6-47bd-b43e-53a0bf345f11 21695-779 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride FOR SUSPENSION ORAL 20100101 NDA NDA022362 Rebel Distributors Corp COLESEVELAM HYDROCHLORIDE 3.75 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] E 20171231 21695-780_c1d62153-8622-40de-a20b-3faecd718736 21695-780 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20010918 ANDA ANDA075788 Rebel Distributors Corp ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-781_fc274f83-4cd6-47bd-b43e-53a0bf345f11 21695-781 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride TABLET, FILM COATED ORAL 20000901 NDA NDA021176 Rebel Distributors Corp COLESEVELAM HYDROCHLORIDE 625 mg/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] E 20171231 21695-782_9e8890f0-e04a-4555-ac8d-d1b792a5c276 21695-782 HUMAN PRESCRIPTION DRUG CEFACLOR CEFACLOR SUSPENSION ORAL 19971002 ANDA ANDA064164 Rebel Distributors Corp CEFACLOR 250 mg/5mL E 20171231 21695-783_8a4c45c0-7eae-4296-ae2e-6d618228dc8b 21695-783 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 Rebel Distributors Corp LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 21695-786_09182072-d05e-4cd4-93c0-d1c0abd6069d 21695-786 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20060823 ANDA ANDA077447 Rebel Distributors Corp MOMETASONE FUROATE 1 mg/g E 20171231 21695-788_1ac2687d-1a70-4a69-b84c-22840925db09 21695-788 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Rebel Distributors Corp LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 21695-789_4e334e50-19c4-449b-b77f-549a461c7f84 21695-789 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20100921 ANDA ANDA062703 Rebel Distributors Corp CEPHALEXIN 125 mg/5mL E 20171231 21695-791_137c4e7a-e671-413e-b687-89490ef98974 21695-791 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20071017 NDA NDA022122 Rebel Distributors Corp DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-792_1cb783ed-5496-4b4d-995b-e81157f9f8d1 21695-792 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20080521 ANDA ANDA078230 Rebel Distributors Corp ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 21695-793_88c5b939-a658-4972-b849-e5c00a447b53 21695-793 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Rebel Distributors Corp ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 21695-794_1cb783ed-5496-4b4d-995b-e81157f9f8d1 21695-794 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20080521 ANDA ANDA078230 Rebel Distributors Corp ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 21695-795_7892fb39-94c6-41cc-b8cd-d9d145180a96 21695-795 HUMAN PRESCRIPTION DRUG LOVAZA omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20081021 NDA NDA021654 Rebel Distributors Corp OMEGA-3-ACID ETHYL ESTERS 1 g/1 E 20171231 21695-796_e1a80191-fcb5-4aab-a972-accabe6ae9c7 21695-796 HUMAN PRESCRIPTION DRUG Amiodarone hydrochloride Amiodarone hydrochloride TABLET ORAL 20090810 ANDA ANDA079029 Rebel Distributors Corp AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 21695-797_c7bc9486-8e61-4ba1-827f-2cd8c304b454 21695-797 HUMAN PRESCRIPTION DRUG Inspra eplerenone TABLET ORAL 20020927 NDA NDA021437 Rebel Distributors Corp EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 21695-798_1cb783ed-5496-4b4d-995b-e81157f9f8d1 21695-798 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20080521 ANDA ANDA078230 Rebel Distributors Corp ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 21695-799_a4fc8ec9-99c6-4739-9f71-0d9062f3ebe9 21695-799 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Rebel Distributors Corp NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-800_a4fc8ec9-99c6-4739-9f71-0d9062f3ebe9 21695-800 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Rebel Distributors Corp NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-801_e463ea06-12a7-463c-90eb-082d0035b55f 21695-801 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 21695-802_a4fc8ec9-99c6-4739-9f71-0d9062f3ebe9 21695-802 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Rebel Distributors Corp NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-803_a5391476-8480-401d-8bb5-0726d8195770 21695-803 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Rebel Distributors Corp DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 21695-804_f5ce22e8-1a9b-408c-86ae-4084b7afeca1 21695-804 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 ANDA ANDA075265 Rebel Distributors Corp TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 21695-805_9e123aad-40bc-45fa-b0ab-5519fd4355b7 21695-805 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 19981224 ANDA ANDA075213 Rebel Distributors Corp TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 21695-806_656726ed-50cd-4f7e-8e51-e242afd1d9c9 21695-806 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET ORAL 19941001 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 E 20171231 21695-807_b10b3eaf-c28d-4d09-93e0-64c3d4090c78 21695-807 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071003 ANDA ANDA077410 Rebel Distributors Corp NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 21695-808_4ae433f5-52bb-4403-984c-32f0fad50dd1 21695-808 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Rebel Distributors Corp BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-809_4ae433f5-52bb-4403-984c-32f0fad50dd1 21695-809 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Rebel Distributors Corp BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-810_85b8863e-b8e0-46f4-94a4-7c8e2c66da3f 21695-810 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET ORAL 20050303 UNAPPROVED DRUG OTHER Rebel Distributors Corp NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 21695-811_9c3fc14a-551c-4957-9074-6b27dfd4a29f 21695-811 HUMAN OTC DRUG Benadryl Allergy Diphenhydramine Hydrochloride TABLET, COATED ORAL 20090101 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 21695-812_a00604ff-041d-4ad4-a3bb-d0911bf0727e 21695-812 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 Rebel Distributors Corp TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 21695-813_a00604ff-041d-4ad4-a3bb-d0911bf0727e 21695-813 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 Rebel Distributors Corp TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 21695-814_e4412a6a-ed4d-410d-8abb-86e1d7b72a3c 21695-814 HUMAN PRESCRIPTION DRUG Propafenone propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110103 ANDA ANDA078540 Rebel Distributors Corp PROPAFENONE 325 mg/1 Antiarrhythmic [EPC] E 20171231 21695-815_b7b0b1a0-2ab3-4697-bee4-0cd7fd5088b9 21695-815 HUMAN PRESCRIPTION DRUG Clarinex Desloratadine TABLET, FILM COATED ORAL 20020208 NDA NDA021297 Rebel Distributors Corp DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 21695-816_923abdb6-1ec5-415a-9269-67e16e8e1fff 21695-816 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 19980313 ANDA ANDA040182 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 167 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 21695-817_9b3db659-f64c-4c48-946a-6b4f1d800eba 21695-817 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 Rebel Distributors Corp DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 21695-818_9b3db659-f64c-4c48-946a-6b4f1d800eba 21695-818 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 Rebel Distributors Corp DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 21695-819_9b3db659-f64c-4c48-946a-6b4f1d800eba 21695-819 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 Rebel Distributors Corp DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 21695-820_e4020ca3-82d0-4668-b4bc-92e4a53c1f4e 21695-820 HUMAN PRESCRIPTION DRUG FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091102 NDA NDA020786 Rebel Distributors Corp FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 21695-821_00bdb48f-8b8f-4cc5-bb63-77213f2279cb 21695-821 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071226 ANDA ANDA076549 Rebel Distributors Corp RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 21695-822_00bdb48f-8b8f-4cc5-bb63-77213f2279cb 21695-822 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071226 ANDA ANDA076529 Rebel Distributors Corp RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 21695-823_00bdb48f-8b8f-4cc5-bb63-77213f2279cb 21695-823 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071226 ANDA ANDA076549 Rebel Distributors Corp RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 21695-826_a1e2c14f-0682-4b19-9159-de0aca1960c6 21695-826 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 19720630 ANDA ANDA080198 Rebel Distributors Corp LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 21695-827_65e1c3ae-a462-4345-8a28-c7d2c0388af8 21695-827 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Rebel Distributors Corp EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 21695-828_52377f5a-0fdc-4ef7-90d1-2fe8c5909286 21695-828 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Rebel Distributors Corp METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 21695-829_4d8f6f8f-a69a-48db-8ee1-3b23989cb11f 21695-829 HUMAN PRESCRIPTION DRUG FLUOROURACIL fluorouracil CREAM TOPICAL 20080411 ANDA ANDA077524 Rebel Distributors Corp FLUOROURACIL 50 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 21695-830_99aca2c3-afe6-4f74-83b8-beb08bb2b502 21695-830 HUMAN PRESCRIPTION DRUG Fexmid cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20081101 ANDA ANDA071611 Rebel Distributors Corp CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 21695-831_27badbda-3635-444e-8005-5d5ee16f8c3c 21695-831 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078385 Rebel Distributors Corp HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 21695-832_796cf6ad-d86a-4c4e-9372-0eb649d3530d 21695-832 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20091203 ANDA ANDA077135 Rebel Distributors Corp VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 21695-834_c5378585-dd35-4123-82b9-91395b56c3eb 21695-834 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Rebel Distributors Corp ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 21695-835_c5378585-dd35-4123-82b9-91395b56c3eb 21695-835 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Rebel Distributors Corp ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 21695-836_66e300a5-f1de-40e0-9b08-8b86e2394016 21695-836 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090601 ANDA ANDA018832 Rebel Distributors Corp. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 21695-837_cc6293ae-1f81-4670-84b2-c00422c690ca 21695-837 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Rebel Distributors Corp ISOSORBIDE MONONITRATE 60 mg/1 E 20171231 21695-838_d751e65a-5086-4303-864b-bd9ed895a239 21695-838 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 20100121 ANDA ANDA075219 Rebel Distributors Corp DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-839_21c7fb80-4f9f-41eb-bebb-eda511980284 21695-839 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19970605 ANDA ANDA074821 Rebel Distributors Corp TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-840_25df52b1-c0b3-49ea-b97f-0763b64db011 21695-840 HUMAN OTC DRUG Almacone Almacone LIQUID ORAL 20081111 OTC MONOGRAPH FINAL part331 Rebel Distributors Corp ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 200; 200 mg/5mL; mg/5mL E 20171231 21695-843_917f576b-ead7-442d-bf90-7fb981210805 21695-843 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 20031223 ANDA ANDA040496 Rebel Distributors Corp BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 750; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 21695-844_5527cd23-567b-4019-8e5c-f71ee7ed2689 21695-844 HUMAN PRESCRIPTION DRUG Terconazole Terconazole CREAM VAGINAL 20050119 ANDA ANDA076043 Rebel Distributors Corp TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] E 20171231 21695-845_3433c754-cc2e-4e72-bd82-16ed4af3144d 21695-845 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 19960209 ANDA ANDA074430 Rebel Distributors Corp DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 21695-846_d8540843-055c-47fb-9cff-81e64b1d41c3 21695-846 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 19970930 NDA NDA020857 Rebel Distributors Corp LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 21695-847_a2c2385e-74a8-4a18-92ec-be8a1380e13a 21695-847 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate dexamethasone sodium phosphate SOLUTION OPHTHALMIC 19850116 ANDA ANDA088771 Rebel Distributors Corp DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-849_faf608f3-a13d-4969-b1a6-bb0bc1de2a8e 21695-849 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; PARENTERAL; SOFT TISSUE 20090305 ANDA ANDA040794 Rebel Distributors Corp METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-850_faf608f3-a13d-4969-b1a6-bb0bc1de2a8e 21695-850 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; PARENTERAL; SOFT TISSUE 20090305 ANDA ANDA040794 Rebel Distributors Corp METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-851_133fb50a-68d3-4d1b-a47a-67d07cc48da5 21695-851 HUMAN PRESCRIPTION DRUG PROAIR HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 19810101 NDA NDA021457 Rebel Distributors Corp ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 21695-852_ccc64ee7-f581-493b-b8c2-6147a0db197e 21695-852 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100310 NDA NDA020381 Rebel Distributors Corp NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 21695-853_97191d37-7c2e-48c6-91bf-0631fd7b1dd8 21695-853 HUMAN PRESCRIPTION DRUG Tigan trimethobenzamide hydrochloride INJECTION INTRAMUSCULAR 20071101 NDA NDA017530 Rebel Distributors Corp TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] E 20171231 21695-854_6791d4f2-c485-4daf-82c7-0cafa9a7a17d 21695-854 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM VAGINAL 20080101 OTC MONOGRAPH FINAL part333C Rebel Distributors Corp MICONAZOLE NITRATE 20 mg/g E 20171231 21695-855_6c095eec-8d92-4b07-8f9e-84bb8c9bc3f8 21695-855 HUMAN PRESCRIPTION DRUG Enpresse levonorgestrel and ethinyl estradiol KIT 20101220 ANDA ANDA075809 Rebel Distributors Corp E 20171231 21695-857_2de68f9e-fa13-4b87-84f9-dbb73883ba40 21695-857 HUMAN PRESCRIPTION DRUG Necon Norethindrone and Ethinyl Estradiol KIT 19870129 ANDA ANDA070687 Rebel Distributors Corp E 20171231 21695-862_e8a485af-a78b-49a0-9bf4-75e1cd5bb740 21695-862 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Rebel Distributors Corp OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-863_e8a485af-a78b-49a0-9bf4-75e1cd5bb740 21695-863 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Rebel Distributors Corp OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-864_e8a485af-a78b-49a0-9bf4-75e1cd5bb740 21695-864 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Rebel Distributors Corp OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 21695-865_ccc64ee7-f581-493b-b8c2-6147a0db197e 21695-865 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970728 NDA NDA020381 Rebel Distributors Corp NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 21695-866_241e7477-ecae-4f84-8410-bbfaa9f57ed0 21695-866 HUMAN PRESCRIPTION DRUG Amlobenz Amlobenz CAPSULE ORAL 20100419 ANDA ANDA077183 Rebel Distributors Corp AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 21695-867_b5504316-3907-444c-b604-ec9a18cdcd6d 21695-867 HUMAN PRESCRIPTION DRUG Mirapex pramipexole dihydrochloride TABLET ORAL 20040101 NDA NDA020667 Rebel Distributors Corp PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 21695-868_98a3ef97-b447-4bfc-b284-13acd00bda5b 21695-868 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100420 ANDA ANDA073568 Rebel Distributors Corp VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 21695-869_95828fad-323e-4510-acbf-6d354b25b887 21695-869 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP ORAL 20080208 ANDA ANDA040613 Rebel Distributors Corp HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] E 20171231 21695-870_fbc8717c-8980-4cab-9518-84eb732df072 21695-870 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20090327 NDA NDA021282 Rebel Distributors Corp GUAIFENESIN 600 mg/1 E 20171231 21695-871_6bb510c8-2ae2-4159-b4c6-0aec5e64b4c9 21695-871 HUMAN PRESCRIPTION DRUG Relpax eletriptan hydrobromide TABLET, FILM COATED ORAL 20021226 NDA NDA021016 Rebel Distributors Corp ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 21695-872_7c960eb1-839d-4d96-ba70-a5068a7b6a67 21695-872 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Rebel Distributors Corp SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 21695-873_7c960eb1-839d-4d96-ba70-a5068a7b6a67 21695-873 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Rebel Distributors Corp SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 21695-874_7c960eb1-839d-4d96-ba70-a5068a7b6a67 21695-874 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Rebel Distributors Corp SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 21695-875_d0da5393-8c1d-48ce-85e6-22213f6a4ba2 21695-875 HUMAN OTC DRUG OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED NASAL 20081211 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 21695-876_f30aa4fe-15ac-4412-afae-fae3b940a74c 21695-876 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 20080101 NDA NDA011722 Rebel Distributors Corp DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 21695-877_56ffd662-60a6-4b43-a7ea-f778714dfbbd 21695-877 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076402 Rebel Distributors Corp. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 21695-878_5e652955-bce3-4b0a-a754-739712725aaf 21695-878 HUMAN OTC DRUG Cetirizine Cetirizine LIQUID ORAL 20080617 ANDA ANDA078398 Rebel Distributors Corp CETIRIZINE HYDROCHLORIDE 5 mg/5mL E 20171231 21695-879_cf051ddf-aca5-4bdc-ac16-27310d5fd59a 21695-879 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 19840220 ANDA ANDA070098 Rebel Distributors Corp METHYLDOPA 250 mg/1 E 20171231 21695-880_cf051ddf-aca5-4bdc-ac16-27310d5fd59a 21695-880 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 19840220 ANDA ANDA070343 Rebel Distributors Corp METHYLDOPA 500 mg/1 E 20171231 21695-881_75d8099b-4e08-43c0-811e-589d4fb52932 21695-881 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxaxin SOLUTION/ DROPS AURICULAR (OTIC) 20080317 ANDA ANDA076616 Rebel Distributors Corp OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-883_1d97ba11-5b69-4ba3-9310-fa000183de43 21695-883 HUMAN PRESCRIPTION DRUG AK-PENTOLATE Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19970113 ANDA ANDA040164 Rebel Distributors Corp. CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL E 20171231 21695-885_65b2f396-666b-4b08-890f-19429844e74b 21695-885 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 21695-888_fdd0e957-a600-40a3-b9c7-2b0fd98a5b12 21695-888 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin Phosphate SOLUTION TOPICAL 19970605 ANDA ANDA064159 Rebel Distributors Corp CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 21695-889_d1b5762f-307c-4c99-977d-d91d7dd22141 21695-889 HUMAN PRESCRIPTION DRUG Diazepam Diazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19871013 ANDA ANDA071583 Rebel Distributors Corp DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 21695-890_04bcee32-714d-4f7c-866d-7872b0808690 21695-890 HUMAN PRESCRIPTION DRUG Belladonna Alkaloids with Phenobartbital Belladonna Alkaloids with Phenobartbital TABLET ORAL 20040831 UNAPPROVED DRUG OTHER Rebel Distributors Corp ATROPINE SULFATE; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; PHENOBARBITAL .0194; .1037; .0065; 16.2 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 21695-892_28e567ca-dd90-45cc-894c-330437497531 21695-892 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20040623 ANDA ANDA076479 Rebel Distributors Corp ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] E 20171231 21695-894_43fb007c-19bb-4a04-b47b-288a4f464c81 21695-894 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20100312 ANDA ANDA077270 Rebel Distributors Corp GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 21695-896_44c1c923-ddcc-41b0-b710-bb61643593e3 21695-896 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19960809 ANDA ANDA040159 Rebel Distributors Corp. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 21695-898_c7eece80-2d36-4aec-89d7-4924ab2aeb92 21695-898 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 E 20171231 21695-899_5db7f199-8752-4d24-85f7-e34ca8f4d02e 21695-899 HUMAN PRESCRIPTION DRUG PRADAXA dabigatran etexilate mesylate CAPSULE ORAL 20101026 NDA NDA022512 Rebel Distributors Corp DABIGATRAN ETEXILATE MESYLATE 150 mg/1 E 20171231 21695-901_eb668bf3-aab0-4529-bf8f-e740a5d5f3b8 21695-901 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080804 ANDA ANDA076768 Rebel Distributors Corp ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 21695-902_eb668bf3-aab0-4529-bf8f-e740a5d5f3b8 21695-902 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080804 ANDA ANDA076768 Rebel Distributors Corp ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 21695-903_c29995d6-e8f2-4e7b-aa03-6ce5aa0e7710 21695-903 HUMAN OTC DRUG Magnesium Hydroxide Magnesium Hydroxide LIQUID ORAL 20100322 OTC MONOGRAPH FINAL part331 Rebel Distributors Corp MAGNESIUM HYDROXIDE 400 mg/5mL E 20171231 21695-905_1f949140-68b5-4602-936f-1936e436d553 21695-905 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960105 NDA NDA020353 Rebel Distributors Corp NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-906_1f949140-68b5-4602-936f-1936e436d553 21695-906 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960105 NDA NDA020353 Rebel Distributors Corp NAPROXEN SODIUM 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-907_aa294be5-9015-4f6a-8a92-a71a2b22d1b2 21695-907 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20030421 ANDA ANDA076369 Rebel Distributors Corp PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] E 20171231 21695-908_1f27bd46-5dde-4b2e-88c0-b450f4b94b84 21695-908 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Rebel Distributors Corp NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 21695-909_6fafbe75-fcae-4afd-9745-02e641cefb31 21695-909 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20061213 ANDA ANDA077899 Rebel Distributors Corp NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 21695-911_46b4392a-47dd-47b5-9f99-13e4c188faa4 21695-911 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20050509 ANDA ANDA076291 Rebel Distributors Corp IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 21695-913_2fd193e2-7aa7-4119-b540-7e28e82fbd13 21695-913 HUMAN PRESCRIPTION DRUG ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20050908 NDA NDA021692 Rebel Distributors Corp TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 21695-914_d4730085-b38e-43ce-bb51-2532da0a3e2b 21695-914 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20091208 ANDA ANDA077245 Rebel Distributors Corp CIPROFLOXACIN 400 mg/40mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-915_297f0888-729c-4ce6-8779-6b239abf3c93 21695-915 HUMAN PRESCRIPTION DRUG AK-Con naphazoline hydrochloride SOLUTION OPHTHALMIC 19740822 ANDA ANDA083590 Rebel Distributors Corp. NAPHAZOLINE HYDROCHLORIDE 1 mg/mL E 20171231 21695-916_43464a6b-a3b8-445b-b020-cf60f0b5e8a4 21695-916 HUMAN PRESCRIPTION DRUG Amlobenz Amlobenz CAPSULE ORAL 20100419 ANDA ANDA077183 Rebel Distributors Corp AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 21695-917_d73a7aa3-5b5f-4532-9936-752366a2430d 21695-917 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Rebel Distributors Corp VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 21695-918_d73a7aa3-5b5f-4532-9936-752366a2430d 21695-918 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Rebel Distributors Corp VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 21695-919_d73a7aa3-5b5f-4532-9936-752366a2430d 21695-919 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Rebel Distributors Corp VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 21695-924_35b99e65-32d3-43bc-89d9-2e7c7838aa14 21695-924 HUMAN PRESCRIPTION DRUG Xolox Oxycodone HCl and Acetaminophen TABLET ORAL 20090301 ANDA ANDA040676 Rebel Distributors Corp OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 500 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 21695-926_843d2e6f-9110-4b0d-894f-63b1b206b5ec 21695-926 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL; SUBLINGUAL 20090921 UNAPPROVED DRUG OTHER Rebel Distributors Corp HYOSCYAMINE SULFATE .125 mg/1 E 20171231 21695-929_e5e84aa0-a99d-47ae-983b-fc03f0f2c754 21695-929 HUMAN OTC DRUG Aprodine Pseudoephedrine HCl and Tripolidine TABLET, FILM COATED ORAL 19930109 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 60; 2.5 mg/1; mg/1 E 20171231 21695-930_785199ea-3bd6-48ea-afd0-e0c4cf39652b 21695-930 HUMAN OTC DRUG Natures Tears Natures Tears SOLUTION/ DROPS OPHTHALMIC 20110329 OTC MONOGRAPH FINAL part349 Rebel Distributors Corp HYPROMELLOSE 2910 (3 MPA.S) 4 mg/mL E 20171231 21695-931_9ab3a26c-a030-43ff-a68d-f40f1e0c2ab1 21695-931 HUMAN OTC DRUG Allegra D 12 Hour Allergy and Congestion fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110303 NDA NDA020786 Rebel Distributors Corp FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 E 20171231 21695-933_472e7b07-83fc-4857-9cc0-50e6aa03f10d 21695-933 HUMAN PRESCRIPTION DRUG TERCONAZOLE terconazole CREAM VAGINAL 20040401 NDA NDA019964 Rebel Distributors Corp TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] E 20171231 21695-934_86c26e3c-27f8-4c59-ac5a-10c6435131bc 21695-934 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20090731 OTC MONOGRAPH NOT FINAL part334 Rebel Distributors Corp MAGNESIUM CITRATE 2.62 g/100mL E 20171231 21695-935_3cd19aeb-0555-44cd-9619-a2490c8c21e1 21695-935 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19930716 ANDA ANDA074165 Rebel Distributors Corp. CLOTRIMAZOLE 50 mg/g E 20171231 21695-939_e463ea06-12a7-463c-90eb-082d0035b55f 21695-939 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 21695-940_e463ea06-12a7-463c-90eb-082d0035b55f 21695-940 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060530 ANDA ANDA040663 Rebel Distributors Corp WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 21695-941_8c9cb953-0995-4f47-83ee-c8c9dfd1b533 21695-941 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Rebel Distributors Corp OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 21695-943_f6ffd0d8-3451-425e-921e-faae1c1b8ad3 21695-943 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Rebel Distributors Corp DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 21695-944_4eff4778-6ae6-4727-821d-66df5683dd9b 21695-944 HUMAN PRESCRIPTION DRUG DESONIDE DESONIDE CREAM TOPICAL 19920630 ANDA ANDA073548 Rebel Distributors Corp DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-945_b1b95503-1c7a-44e8-b5e0-d50b61db99d5 21695-945 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate KIT 20060510 NDA NDA021928 Rebel Distributors Corp E 20171231 21695-946_b1b95503-1c7a-44e8-b5e0-d50b61db99d5 21695-946 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Rebel Distributors Corp VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] E 20171231 21695-947_ad07e9bf-cc81-4736-86c7-2b2de9386eb2 21695-947 HUMAN PRESCRIPTION DRUG epinephrine epinephrine INJECTION SUBCUTANEOUS 20100331 NDA AUTHORIZED GENERIC NDA020800 Rebel Distributors Corp EPINEPHRINE .3 mg/1 Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 21695-948_b639732f-8eb2-4592-aca3-86faf7e5360b 21695-948 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060622 NDA NDA021610 Rebel Distributors Corp OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 21695-949_b639732f-8eb2-4592-aca3-86faf7e5360b 21695-949 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060622 NDA NDA021610 Rebel Distributors Corp OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 21695-950_44a4e8de-0430-48f8-8178-093afcded438 21695-950 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20090803 ANDA ANDA076862 Rebel Distributors Corp METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-951_a1b2e514-b75d-4f01-a9fd-83151f0ce813 21695-951 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Rebel Distributors Corp OXYCODONE HYDROCHLORIDE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 21695-952_41fa78f5-8f41-415e-80f3-7fee7091df5e 21695-952 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Rebel Distributors Corp METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-953_087ae128-1a5d-406e-8bd3-15cb640f6922 21695-953 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071001 NDA NDA021777 Rebel Distributors Corp CYCLOBENZAPRINE HYDROCHLORIDE 30 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 21695-954_e08d5f22-f9c3-4627-8e5a-72c95183cf6a 21695-954 HUMAN PRESCRIPTION DRUG TREXIMET sumatriptan succinate and naproxen sodium TABLET, FILM COATED ORAL 20080425 NDA NDA021926 Rebel Distributors Corp SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM 85; 500 mg/1; mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 21695-955_f2073122-5138-41ba-b791-a9b088bb98b7 21695-955 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan SPRAY, METERED NASAL 20100608 NDA NDA021450 Rebel Distributors Corp ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 21695-956_3f30e6a5-f3c0-4c20-b1a2-142575eb0e24 21695-956 HUMAN PRESCRIPTION DRUG MAXALT rizatriptan benzoate TABLET ORAL 19980629 NDA NDA020864 Rebel Distributors Corp RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 21695-957_5fab494d-cda2-4307-af04-0ce5fce1b2f9 21695-957 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA NDA020699 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-958_5fab494d-cda2-4307-af04-0ce5fce1b2f9 21695-958 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA NDA020699 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-959_c809171c-d424-4a17-a98d-f280a892b410 21695-959 HUMAN PRESCRIPTION DRUG Promethegan promethazine hydrochloride SUPPOSITORY RECTAL 20020205 ANDA ANDA040428 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 21695-960_e5bf608e-c6dd-44e8-96aa-ba4660f64de0 21695-960 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Rebel Distributors Corp SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 21695-961_5fab494d-cda2-4307-af04-0ce5fce1b2f9 21695-961 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA NDA020699 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 21695-965_11d1e166-9577-47b0-a338-d11ab3ba44aa 21695-965 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100611 ANDA ANDA077135 Rebel Distributors Corp VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 21695-966_80ed0406-cf05-423e-b5e7-4e544a88b0ed 21695-966 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA090528 Rebel Distributors Corp LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 21695-967_289bda32-6198-4072-a9f3-283438bda707 21695-967 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060401 ANDA ANDA076467 Rebel Distributors Corp GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 21695-968_68cca7e1-120c-4ac6-8851-15a17e11bd9f 21695-968 HUMAN PRESCRIPTION DRUG VIGAMOX moxifloxacin hydrochloride SOLUTION OPHTHALMIC 20030507 NDA NDA021598 Rebel Distributors Corp MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 21695-969_895c2307-aeeb-49fd-ac3d-750a463fc3ef 21695-969 HUMAN PRESCRIPTION DRUG CIPRODEX ciprofloxacin and dexamethasone SUSPENSION AURICULAR (OTIC) 20030815 NDA NDA021537 Rebel Distributors Corp CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE 3; 1 mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-970_6243f28a-e7ed-4571-beb3-2562c5e033c7 21695-970 HUMAN PRESCRIPTION DRUG QUADRAPAX Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide ELIXIR ORAL 20110506 UNAPPROVED DRUG OTHER Rebel Distributors Corp PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] CIV E 20171231 21695-971_0db4485b-2924-4113-af76-117ad48367b6 21695-971 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate Hydrocortisone Butyrate CREAM TOPICAL 20090901 NDA NDA018514 Rebel Distributors Corp HYDROCORTISONE BUTYRATE 1 mg/g E 20171231 21695-972_7e87a7ee-b16e-464a-a77c-0f7a40e04cf7 21695-972 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Rebel Distributors Corp METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-973_e17b3ec0-7739-4775-b7a2-a262f4f3a836 21695-973 HUMAN PRESCRIPTION DRUG Plan B One-Step levonorgestrel TABLET ORAL 20090710 NDA NDA021998 Rebel Distributors Corp LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] E 20171231 21695-975_67cb9ea4-5adb-4a3a-9568-266b6f472078 21695-975 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110209 ANDA ANDA077154 Rebel Distributors Corp FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 21695-978_4339d964-1997-4c0e-973e-aa69b123b33d 21695-978 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl SOLUTION ORAL 19920713 ANDA ANDA073243 Rebel Distributors Corp LOPERAMIDE HYDROCHLORIDE 1 mg/5mL E 20171231 21695-979_b4b09d4a-dbe9-4f41-ac04-d4f71743722f 21695-979 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 20110120 ANDA ANDA073481 Rebel Distributors Corp FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-980_f5480c36-4401-49f2-b550-912e01527ac8 21695-980 HUMAN OTC DRUG Docusate Calcium Docusate Calcium CAPSULE ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 Rebel Distributors Corp DOCUSATE CALCIUM 240 mg/1 E 20171231 21695-982_14e43813-665c-4cef-b3b1-60eafc880f41 21695-982 HUMAN PRESCRIPTION DRUG Proctofoam HC hydrocortisone acetate and pramoxine hydrochloride AEROSOL, FOAM TOPICAL 19780726 ANDA ANDA086195 Rebel Distributors Corp HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 100; 100 mg/10g; mg/10g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 21695-985_f9b4404c-67bc-4c8a-aa75-1d668a6eed16 21695-985 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA077308 Rebel Distributors Corp KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 21695-986_213a0003-da2b-4b91-9281-c05a73f94e46 21695-986 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION/ DROPS OPHTHALMIC 20110322 ANDA ANDA201006 Rebel Distributors Corp LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] E 20171231 21695-987_047340e3-e6fc-42c7-b552-46b633069bd2 21695-987 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20070223 ANDA ANDA040813 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 21695-988_88ff4e25-bef7-4a8b-a292-23878baac116 21695-988 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Rebel Distributors Corp LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-989_41a61cf1-30a3-472b-a592-b17a610daaba 21695-989 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Rebel Distributors Corp LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 21695-990_611e1f43-1442-4cbb-b7eb-b65de15c6c70 21695-990 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100701 ANDA ANDA079220 Rebel Distributors Corp ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 21695-993_2001c00c-89ba-4d36-b39b-a5374a368427 21695-993 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Rebel Distributors Corp GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 21695-994_88ff4e25-bef7-4a8b-a292-23878baac116 21695-994 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Rebel Distributors Corp LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 21695-995_9e8e429c-1960-4acd-8bc5-5002d4c6a6ac 21695-995 HUMAN PRESCRIPTION DRUG Aviane 28 Day levonorgestrel and ethinyl estradiol KIT 19950824 ANDA ANDA075796 Rebel Distributors Corp E 20171231 21695-996_d346d08d-ebb5-4500-923f-fe111f304876 21695-996 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20111227 ANDA ANDA079081 Rebel Distributors Corp LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 21695-997_a61e6ba8-b342-4815-9623-eb0c319ecc74 21695-997 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20040419 ANDA ANDA074623 Rebel Distributors Corp LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 21724-701_785ab65b-b186-4e0b-bec0-60a920123e2e 21724-701 HUMAN PRESCRIPTION DRUG Procentra dextroamphetamine sulfate SOLUTION ORAL 20140515 ANDA ANDA040776 Independence Pharmaceuticals, LLC DEXTROAMPHETAMINE SULFATE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 21731-647_4d55f840-8daf-45e7-980d-91a1e4087add 21731-647 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20111201 ANDA ANDA204525 Centre for Probe Development and Commercialization FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 21749-022_ee69d167-3e98-4708-a1c1-ba5aeb198a9b 21749-022 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Biobased Content ALCOHOL LIQUID TOPICAL 20170415 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-027_635d36a9-318e-4788-b238-4b4ac798365e 21749-027 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer be Peaceful alcohol GEL TOPICAL 20161222 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-028_e041f4eb-d820-471f-84b4-291aacdd27ba 21749-028 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer be Vibrant alcohol GEL TOPICAL 20161222 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-029_f5fc7233-5ba1-4da7-9a48-963dd0a58cd1 21749-029 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer be Blissful alcohol GEL TOPICAL 20161222 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-050_7ee67b65-fd9a-4666-90f2-9cbb0cb8ade3 21749-050 HUMAN OTC DRUG GOJO Antimicrobial Ltn Sp Chloroxylenol LIQUID TOPICAL 20030713 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-060_e491e751-81f5-48f0-8d05-e872d343d3b8 21749-060 HUMAN OTC DRUG GOJO RICH PINK Antibacterial Ltn Sp Chloroxylenol LIQUID TOPICAL 20030731 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-080_645faecc-1e12-41cd-a77d-a3e0dd88fb26 21749-080 HUMAN OTC DRUG Luxury Foam Antibacterial Chloroxylenol LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-085_723223a9-b8cc-4c77-9dec-0348f12a0264 21749-085 HUMAN OTC DRUG Premium Foam Antibacterial Chloroxylenol LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-090_0a509681-dbda-4e70-83ff-9700c2a73d27 21749-090 HUMAN OTC DRUG PROVON Foaming Antimicrobial Handwash with Moisturizers Chloroxylenol LIQUID TOPICAL 20030713 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-094_8f9a87b8-0d39-41fb-a84d-429d3b160caf 21749-094 HUMAN OTC DRUG PROVON Medicated Foam Handwash with Advanced Moisturizers and Triclosan Triclosan LIQUID TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. TRICLOSAN .003 mg/mL E 20171231 21749-095_53f64ed6-43d0-4d84-a11d-332f2d5fe989 21749-095 HUMAN OTC DRUG MICRELL Antibacterial Foam Handwash CHLOROXYLENOL LIQUID TOPICAL 20060623 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .005 mg/mL N 20181231 21749-096_6636db30-8c87-467c-817c-1c6123c8a3ad 21749-096 HUMAN OTC DRUG PROVON Foaming Medicated Handwash with Moisturizers and Triclosan Triclosan LIQUID TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. TRICLOSAN .003 mg/mL E 20171231 21749-100_2aa30898-5579-4e70-becc-aeabe4139998 21749-100 HUMAN OTC DRUG PURELL Foaming Hand Sanitizer Alcohol AEROSOL, FOAM TOPICAL 20050701 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .625 mL/mL N 20181231 21749-135_f7242210-6e82-46c5-950b-0e6f3946d384 21749-135 HUMAN OTC DRUG GOJO E2 Sanitizing Ltn Sp TRICLOSAN LIQUID TOPICAL 20040917 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. TRICLOSAN .003 mg/mL N 20181231 21749-142_4a2d0c78-5ee5-4613-8af0-5cb2155a2ecf 21749-142 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Moonlit Moments ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-143_b5b99529-2d1a-4a75-a90d-c9b70fe506f5 21749-143 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Tranquil Sunset ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-144_ad6af0f7-a439-47b1-be44-ede5eaeb3809 21749-144 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Revitalizing Rain ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-145_c029e405-764a-439c-9e3f-024dc296c767 21749-145 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Fresh Peach Blossoms ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-146_ba412222-4fd0-4a97-adc6-1b6f3b78b30e 21749-146 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Refreshing Florals ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-147_9ffa8ce8-ec4f-4267-9769-05fd861c7878 21749-147 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Inspiring Island Getaway ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-150_7dc6a64a-302a-4769-a33f-56e75eed6eef 21749-150 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Sweet Plum ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-151_ac14519c-bfcb-42de-a14e-1cb1d55722f2 21749-151 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Wintergreen Mint ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-152_b15f6a5d-704a-43cf-ac1f-fce76ba942b5 21749-152 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer O Christmas Tree Alcohol GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-153_0696705d-05f7-49ee-b510-0e43120e094b 21749-153 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Holiday Spice alcohol GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-205_15eb7df5-de8e-4061-aa6d-bd33bdd2c6be 21749-205 HUMAN OTC DRUG FOMA Antimicrobial Ltn Sp Chloroxylenol LIQUID TOPICAL 20110630 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-211_3e902871-9f17-40e5-bbe3-d66305a83540 21749-211 HUMAN OTC DRUG GOJO Ultra Mild Antimicrobial Ltn Sp with Chloroxylenol Chloroxylenol LIQUID TOPICAL 20000824 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-250_9999b8d5-34c7-41e7-8928-750348009a20 21749-250 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Winterberry Delight ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-251_246654a0-1ff9-4675-906c-95390a1c6e21 21749-251 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Fresh Peppermint Cheer ALCOHOL GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-252_91fbb89b-1d1d-44ec-af30-03d396dcca5c 21749-252 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Aspen Retreat Alcohol GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-253_1365faa3-e359-4135-9dce-7d707f77292a 21749-253 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Winter Wonderland Spice alcohol GEL TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-254_5f8203e3-9e82-4ad2-821d-46a3c3322de9 21749-254 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Oven-Baked Apples ALCOHOL GEL TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-255_7ad30805-11a8-4dca-98bf-343156b4188e 21749-255 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Warm Fireplace Gathering ALCOHOL GEL TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-256_48efe0a4-1bc7-481d-a9c2-71cf7653bfa9 21749-256 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Warm Holiday Treats ALCOHOL GEL TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-291_361527a0-62d1-4f80-8947-d655c4bbd155 21749-291 HUMAN OTC DRUG SIGNATRY Ultra Antimicrobial Ltn Sp Chloroxylenol LIQUID TOPICAL 20010919 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-354_ca28cbfd-2e09-48f0-891b-1267aeed25d9 21749-354 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Grandma s Apple Delight ALCOHOL GEL TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-355_8f158b97-def0-4c4f-8c49-3127dc54066b 21749-355 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Winter Jubilee ALCOHOL GEL TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-356_d74fce10-f36a-4830-ab21-f93d4c29af6a 21749-356 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Coconut Beach Siesta ALCOHOL GEL TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-357_a1ed4e9a-3173-45a9-b34b-7b5d2e2e2e1f 21749-357 HUMAN OTC DRUG PURELL Hand Sanitizing Wipes Fragrance Free Benzalkonium Chloride Wipe LIQUID TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .00013 1/1 N 20181231 21749-358_326ec6ed-9196-4af1-a22f-420aa06794d6 21749-358 HUMAN OTC DRUG PURELL Hand Sanitizing Wipes Fresh Citrus Scent Benzalkonium Chloride Wipe LIQUID TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .00013 1/1 N 20181231 21749-359_0658b4a5-a8eb-4bf7-aff4-8c40c1e79b38 21749-359 HUMAN OTC DRUG PURELL Hand Sanitizing Wipes Clean Refreshing Scent Benzalkonium Chloride Wipe LIQUID TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .00013 1/1 N 20181231 21749-363_b854e527-5e16-4493-b319-0440fb08a3d9 21749-363 HUMAN OTC DRUG Purell Sanitizing Hand Wipes ethyl alcohol CLOTH TOPICAL 20070122 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc ALCOHOL .62 mL/mL E 20171231 21749-364_fc19689f-4826-4adf-8292-ea002cc4ad05 21749-364 HUMAN OTC DRUG PURELL Cottony Soft alcohol SWAB TOPICAL 20120224 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .62 mL/mL E 20171231 21749-366_195f1abe-2cc3-49a9-9e89-fefa7a513f0c 21749-366 HUMAN OTC DRUG Purell Personal Pack Sanitizing alcohol SWAB TOPICAL 20120314 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .62 mL/mL E 20171231 21749-367_d1df10ff-1632-494a-8476-d15b48b79ba5 21749-367 HUMAN OTC DRUG Purell Alcohol Formulation alcohol SWAB TOPICAL 20120224 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .62 mL/mL N 20181231 21749-368_70e0e729-4203-4258-97d3-2ad2eabf41e6 21749-368 HUMAN OTC DRUG PURELL Sanitizing Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20120314 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .0013 1/1 N 20181231 21749-400_9fd11a84-5f6c-4b97-8ff2-fdb91908455e 21749-400 HUMAN OTC DRUG Excelon Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170614 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 21749-405_2fbf30fc-75d0-4c4d-acef-7d555df406a9 21749-405 HUMAN OTC DRUG GOJO Pink Antimicrobial Ltn Sp Chloroxylenol LIQUID TOPICAL 20010626 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-415_6eeacde2-89db-430d-9ca3-0609246891c1 21749-415 HUMAN OTC DRUG TRICLOSAN TRICLOSAN LIQUID TOPICAL 20100310 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. TRICLOSAN .003 mL/mL E 20171231 21749-417_c1313d41-2176-425c-b133-e1f895a00180 21749-417 HUMAN OTC DRUG GOJO Antibacterial Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. TRICLOSAN .003 mg/mL E 20171231 21749-430_45dea601-4b0f-4786-8caf-d778db33a6db 21749-430 HUMAN OTC DRUG PROVON Antibacterial Perineal Wash Triclosan LIQUID TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. TRICLOSAN .0015 mg/mL E 20171231 21749-441_4d894127-eeb1-4c1a-8291-6340494db2ba 21749-441 HUMAN OTC DRUG PROVON Perineal Skin Protectant with 60% Petrolatum PETROLATUM CREAM TOPICAL 20100501 OTC MONOGRAPH FINAL part347 GOJO Industries, Inc. PETROLATUM .6 g/g N 20181231 21749-442_18b774bd-1fde-407c-a5b7-8b48e730fbc7 21749-442 HUMAN OTC DRUG PROVON Perineal Skin Prot with 99 Petrolatum Petrolatum OINTMENT TOPICAL 20100501 OTC MONOGRAPH FINAL part347 GOJO Industries, Inc. PETROLATUM .99 g/g E 20171231 21749-454_94e13ecc-0f72-4ba9-9d58-8311e3c740e9 21749-454 HUMAN OTC DRUG Primory Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170614 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 21749-480_d90acded-e708-4dfb-bd40-c60eb8e94359 21749-480 HUMAN OTC DRUG PURELL Advanced Skin Balancing Hand Sanitizer Alcohol GEL TOPICAL 20161230 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20191231 21749-485_13a1c67f-f805-46c8-9a9c-48c48ce9af38 21749-485 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Nourishing Alcohol GEL TOPICAL 20161230 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20191231 21749-501_c51e8e89-0974-49a0-96bb-f829aae8a988 21749-501 HUMAN OTC DRUG GOJO Gold and Klean Antimicrobial Ltn Sp Chloroxylenol LIQUID TOPICAL 20030713 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-506_a300e028-8c19-4ce4-8901-874cf0b4b1d0 21749-506 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100303 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .62 mL/mL E 20171231 21749-510_86c4f6c5-2ce6-4c17-9bca-056db56c91f9 21749-510 HUMAN OTC DRUG PURELL Instant Hand Sanitizer Ocean Mist ALCOHOL GEL TOPICAL 20070301 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .62 mL/mL N 20181231 21749-515_ccf8fd3f-673e-4668-96e0-1cfad1ed6907 21749-515 HUMAN OTC DRUG PURELL Instant Hand Sanitizer Foam (ETHYL ALCOHOL) ALCOHOL GEL TOPICAL 20101214 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .62 mL/mL E 20171231 21749-520_dd592fe3-1871-4463-a9c2-dedf51aecb85 21749-520 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100304 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .62 mL/mL E 20171231 21749-521_d746a3b9-4ac9-43e6-935f-deff6267bdfa 21749-521 HUMAN OTC DRUG GOJO Antimicrobial Foam Handwash with PCMX CHLOROXYLENOL LIQUID TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .005 mg/mL N 20181231 21749-522_31cf7122-71f5-4ab4-983c-8bf4298a10a6 21749-522 HUMAN OTC DRUG PURELL Healthcare HEALTHY SP 0.5pct PCMX Antimicrobial Foam Chloroxylenol LIQUID TOPICAL 20170714 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .005 mg/mL N 20181231 21749-523_c5b3d13f-e93e-4b31-a0ea-e396e0de8f2d 21749-523 HUMAN OTC DRUG GOJO E2 Foam Handwash with PCMX GOJO E2 Foam Handwash with PCMX LIQUID TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .5 mg/100mL N 20181231 21749-525_98b92452-3201-413a-b29f-d29b788cf891 21749-525 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-526_ecb17e33-4471-4d4b-92b4-8ab4afb85e28 21749-526 HUMAN OTC DRUG PURELL VF481 Hand Sanitizer ALCOHOL GEL TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-527_afcab252-ccd6-45e9-b5c8-74b10ac5bef2 21749-527 HUMAN OTC DRUG Purell Instant Ultra alcohol GEL TOPICAL 20120224 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-528_f339d960-8f11-4017-be6b-c130b9146679 21749-528 HUMAN OTC DRUG PURELL Food Processing HEALTHY SP 0.5pct PCMX Antimicrobial E2 Foam Handwash Chloroxylenol LIQUID TOPICAL 20171015 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .005 mg/mL N 20181231 21749-530_2e43235e-08b5-4d9a-b88a-9f2b60161958 21749-530 HUMAN OTC DRUG PURELL Advanced Instant Hand Sanitizer Fragrance Free ALCOHOL LIQUID TOPICAL 20140214 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20191231 21749-533_db57037d-8827-4438-9729-1c2c49db529c 21749-533 HUMAN OTC DRUG PROVON Antibacterial Foam Handwash Triclosan LIQUID TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. TRICLOSAN .003 mg/mL E 20171231 21749-540_8e51388c-0425-4d51-b1bc-aa45edee9acf 21749-540 HUMAN OTC DRUG Antibacterial Plum Foam Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. TRICLOSAN .003 mg/mL E 20171231 21749-541_d853cc05-288e-42fd-aeca-e3c971be71d0 21749-541 HUMAN OTC DRUG PROVON Foaming Antimicrobial Handwash with PCMX CHLOROXYLENOL LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .005 mg/mL N 20181231 21749-542_74d1743f-585d-44e8-ab94-eac49de581d0 21749-542 HUMAN OTC DRUG PROVON Antibacterial Plum Foam Handwash Triclosan LIQUID TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. TRICLOSAN .003 mg/mL E 20171231 21749-545_820c1daf-6f68-4314-947c-b9c029bbfd1b 21749-545 HUMAN OTC DRUG Signatry Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170614 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 21749-548_efe9fd74-1059-4d97-987b-8290c3aaec5f 21749-548 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Watermelon Splash ALCOHOL GEL TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-549_c35a536b-db2a-4501-8e1c-1389d6bee669 21749-549 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Sweet Papaya Mango ALCOHOL GEL TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-551_f8bcf1f7-5e8c-4baa-9d17-d22c0f5d2d2b 21749-551 HUMAN OTC DRUG ACQUAINT Antibacterial Foam Handwash Chloroxylenol LIQUID TOPICAL 20040909 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-554_4ec70611-a53e-429d-83af-eccaf7101a9b 21749-554 HUMAN OTC DRUG FOMA Antimicrobial Foam Chloroxylenol LIQUID TOPICAL 20040909 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-555_b8c1c780-4fc7-4164-9623-cb8c7a45674f 21749-555 HUMAN OTC DRUG PRIMORY Antimicrobial Foam Chloroxylenol LIQUID TOPICAL 20040909 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-556_793fc835-4af1-4b21-9c16-94a8b22fd1b1 21749-556 HUMAN OTC DRUG Purell Advanced Hand Sanitizer Sprinkled With Love ALCOHOL GEL TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-575_867d8120-b42e-4be6-b0a6-86594334cc8f 21749-575 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Warm Fall Spice Alcohol GEL TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-576_176b91d2-166b-481f-9e5f-47a4604153b7 21749-576 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Pumpkin Delight alcohol GEL TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-577_ab48d5cb-51d5-4895-9300-a84ab8fc5be8 21749-577 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Nightime Winterberry Alcohol GEL TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-578_ccc0d2de-7c0f-493a-a416-09980ea91573 21749-578 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Blushing Pink Orchid Alcohol GEL TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-579_2a2b0472-6095-49ca-97a2-54681b629332 21749-579 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Mandarin Medley Alcohol GEL TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-580_319b7e8f-e38b-455b-a812-6462de49b134 21749-580 HUMAN OTC DRUG EXCELON Antimicrobial Foam Chloroxylenol LIQUID TOPICAL 20040909 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-581_743afcac-495a-4995-93ae-9865efa96119 21749-581 HUMAN OTC DRUG SIGNATRY Antimicrobial Foam Chloroxylenol LIQUID TOPICAL 20040909 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-600_374d438a-f2af-4c3f-b4df-e60bc84f8fcf 21749-600 HUMAN OTC DRUG Primory Clean Skin Antibacterial Ltn Sp Chloroxylenol LIQUID TOPICAL 20130831 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-607_aab02796-7577-48d0-9637-c5ddb8d0b4ff 21749-607 HUMAN OTC DRUG PURELL SF607 Instant Hand Sanitizing BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL E 20171231 21749-625_3910d8de-002f-46ed-8e1b-b9220e8c6dc5 21749-625 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Naturals Gel Alcohol GEL TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-655_d4e12983-90a1-4514-9cd5-118572425d0a 21749-655 HUMAN OTC DRUG PURELL Instant Hand Sanitizer Moisture Therapy ALCOHOL LIQUID TOPICAL 20071001 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .62 mL/mL N 20181231 21749-685_8af22b64-4753-43e0-bd19-5237b8496a46 21749-685 HUMAN OTC DRUG PURELL Professional HEALTHY SP 0.5pct BAK Antimicrobial Foam Benzalkonium Chloride LIQUID TOPICAL 20171015 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 21749-686_6089e457-1db6-4a5a-b07e-ef0e44c2795d 21749-686 HUMAN OTC DRUG PURELL Foodservice HEALTHY SP 0.5pct BAK Antimicrobial Foam Benzalkonium Chloride LIQUID TOPICAL 20171015 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 21749-700_b14587d9-ce77-4b0a-9ba9-11d8663022f3 21749-700 HUMAN OTC DRUG PURELL Advanced Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110510 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-701_99873253-c1e6-4e70-892b-26b991986787 21749-701 HUMAN OTC DRUG PURELL Advanced Skin Nourishing Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-702_b7479baf-1586-4c1a-81c3-110f01a29ee6 21749-702 HUMAN OTC DRUG PURELL Advanced Green Certified Instant Hand Sanitizer alcohol GEL TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-703_dba705d4-6818-48f0-b40e-3a00d1228f52 21749-703 HUMAN OTC DRUG PURELL Advanced with Aloe Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110505 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-704_ffe57332-c058-46b9-9538-6c576ffc31a9 21749-704 HUMAN OTC DRUG Purell Advanced Refreshing alcohol GEL TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-705_efc96b9c-fbda-4386-a766-0e9a08d4d099 21749-705 HUMAN OTC DRUG Purell Advanced Refreshing Aloe alcohol GEL TOPICAL 20120314 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-706_5e168586-fa32-4c15-bb17-f48de8699e29 21749-706 HUMAN OTC DRUG PURELL Advanced E3 Rated Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130331 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-715_ea2e5cf4-06c7-493b-a72a-b5b3497d9dcc 21749-715 HUMAN OTC DRUG PURELL Professional Advanced Hand Sanitizer Gel alcohol GEL TOPICAL 20171015 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-716_b0094f98-bc8d-4cce-8da7-88f9bf64bda4 21749-716 HUMAN OTC DRUG PURELL Healthcare Advanced Hand Sanitizer Gel alcohol GEL TOPICAL 20171015 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-717_d5a135b4-b863-4f33-a9f4-72944b76f80f 21749-717 HUMAN OTC DRUG PURELL Professional Advanced Hand Sanitizer Fragrance Free Gel alcohol GEL TOPICAL 20171015 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-718_0585f0e1-bca1-46f4-bb73-289bf3caa83d 21749-718 HUMAN OTC DRUG PURELL Professional Advanced Hand Sanitizer Fragrance Free Gel alcohol GEL TOPICAL 20171015 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-719_b6e7d766-a399-4e32-b180-6c047bda2e6b 21749-719 HUMAN OTC DRUG PURELL Education Hand Sanitizer SF607 Foam BENZALKONIUM CHLORIDE LIQUID TOPICAL 20171015 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .0013 mg/mL N 20181231 21749-740_48bf3366-706d-46af-8bb7-7c7575a6de9d 21749-740 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Ocean Kiss alcohol GEL TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-745_dfaa6e06-b60a-4ece-9a40-8763832a8965 21749-745 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer SpongeBob Splash alcohol GEL TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-750_8b1c9ef6-a88e-4eea-8d4c-829d15e44f0d 21749-750 HUMAN OTC DRUG PROVON Antimicrobial Ltn Sp with 0.3% PCMX Chloroxylenol LIQUID TOPICAL 20130831 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-801_dfa86bfa-0f6a-4a9a-b968-3c15d4a2b2f4 21749-801 HUMAN OTC DRUG PURELL Advanced Skin Nourishing Instant Hand Sanitizer alcohol LIQUID TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-801_fce7203c-6b00-42d1-acee-9b0dc7a86012 21749-801 HUMAN OTC DRUG PURELL Advanced Skin Nourishing Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-802_6cce0d3d-b7ca-4cb7-8c64-f1a8280b8315 21749-802 HUMAN OTC DRUG PURELL Advanced E3 Rated Instant Hand Sanitizer Foam alcohol LIQUID TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-805_eb2f016e-4d34-4513-9a42-e1f6428eb0dc 21749-805 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Spring Bloom Gel alcohol GEL TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-806_696ee2d2-f1a2-4e60-971d-935d573f101a 21749-806 HUMAN OTC DRUG PURELL Advanced Green Certified Instant Hand Sanitizer alcohol LIQUID TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-807_ae2921c7-2c21-43e9-8a06-9856f7e073ea 21749-807 HUMAN OTC DRUG PURELL Advanced Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-810_2035dca4-1dc4-4806-b1c0-caaa1ecc1cde 21749-810 HUMAN OTC DRUG PURELL Professional Advanced Hand Sanitizer Foam ALCOHOL LIQUID TOPICAL 20170905 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-811_ab45f57c-fe2b-4866-88a4-276e5df27a00 21749-811 HUMAN OTC DRUG PURELL Healthcare Advanced Hand Sanitizer Foam ALCOHOL LIQUID TOPICAL 20170905 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-812_6f2eddd4-1499-4109-8732-682ea7e6758c 21749-812 HUMAN OTC DRUG PURELL Foodservice Advanced Hand Sanitizer Foam ALCOHOL LIQUID TOPICAL 20170905 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-821_b2d1e540-1c96-4d7c-9ed0-8224e1365be2 21749-821 HUMAN OTC DRUG PURELL Professional Advanced Hand Sanitizer Fragrance Free Foam alcohol LIQUID TOPICAL 20170905 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-822_e373c1c4-efc2-4a9a-9b54-d7687e12d735 21749-822 HUMAN OTC DRUG PURELL Healthcare Advanced Hand Sanitizer Gentle and Free Foam alcohol LIQUID TOPICAL 20170905 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-823_4d1ee7da-3487-46f9-9903-129739f7a312 21749-823 HUMAN OTC DRUG PURELL Education Advanced Hand Sanitizer Gentle and Free Foam alcohol LIQUID TOPICAL 20170905 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-824_69525c06-73bd-4434-9a98-14e1168685a9 21749-824 HUMAN OTC DRUG PURELL Food Processing Advanced Hand Sanitizer E3 Foam alcohol LIQUID TOPICAL 20170905 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-825_97334fbe-e0c0-4fee-9fd7-becb7e133702 21749-825 HUMAN OTC DRUG PURELL Foodservice Advanced Hand Sanitizer VF481 Gel ALCOHOL GEL TOPICAL 20171015 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-850_3657d700-8b81-0293-e054-00144ff8d46c 21749-850 HUMAN OTC DRUG Provon Antimicrobial Foam Handwash Chlorhexidine Gluconate 2% SOLUTION TOPICAL 20160501 NDA NDA019422 Gojo Industries, Inc. CHLORHEXIDINE GLUCONATE 20 mg/mL N 20181231 21749-850_3ac039ed-44b9-625c-e054-00144ff8d46c 21749-850 HUMAN OTC DRUG Provon Antimicrobial Foam Handwash Chlorhexidine Gluconate 2% SOLUTION TOPICAL 20160701 NDA NDA019422 Gojo Industries, Inc. CHLORHEXIDINE GLUCONATE 20 mg/mL N 20181231 21749-852_bc904029-aaa2-4446-b082-5363304fedfe 21749-852 HUMAN OTC DRUG PURELL Advanced Hand Sanitizer Ultra Nourishing Foam ALCOHOL LIQUID TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-853_8650f8c6-1a9e-4cf7-936c-1ae2b630d03a 21749-853 HUMAN OTC DRUG GOJO Antibacterial Plum Foam Handwash with Biobased content Benzalkonium Chloride LIQUID TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 21749-854_7b0b0015-edfd-4fa5-9a72-8de38317ec21 21749-854 HUMAN OTC DRUG PURELL Healthcare Advanced Hand Sanitizer ULTRA NOURISHING Foam ALCOHOL LIQUID TOPICAL 20171015 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-911_1e91a2d7-3fab-4eb9-9320-b9fdd7a32978 21749-911 HUMAN OTC DRUG PURELL Sanitizing Wipes Clean Refreshing Scent Benzalkonium Chloride LIQUID TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .00115 1/1 E 20171231 21749-965_f8bb3a71-67d8-435b-9a5b-7649a07b6841 21749-965 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100315 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .62 mL/mL E 20171231 21749-967_c767f6de-9d6a-4f90-bb42-0e4011ca117d 21749-967 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21749-968_07c96f77-c963-4eea-95ea-09ee0744e711 21749-968 HUMAN OTC DRUG GOJO Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170614 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 21749-975_7dfd56fa-1591-40ba-87d4-db48a535e4ae 21749-975 HUMAN OTC DRUG MICRELL Antibacterial Ltn Sp Chloroxylenol LIQUID TOPICAL 19980730 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 21749-987_63d51d38-ccd5-4902-80e4-5e46f81ac5d1 21749-987 HUMAN OTC DRUG PURELL Green Certified Instant Hand Sanitizer Foam (ETHYL ALCOHOL) ALCOHOL LIQUID TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-992_fbeebc0d-12ed-4beb-89d5-c6389398d088 21749-992 HUMAN OTC DRUG PURELL Waterless Surgical Scrub alcohol LIQUID TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333E GOJO Industries, Inc. ALCOHOL .7 mL/mL N 20181231 21749-993_e0ff1078-ae84-446e-8872-db42766dbf9c 21749-993 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 GOJO Industries, Inc. ALCOHOL .7 mL/mL E 20171231 21839-011_377bd4d5-77fd-4361-903f-b974c33aa90b 21839-011 HUMAN OTC DRUG Ultra Sensitive Faceblock SPF 25 Titanium Dioxide LOTION TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 Gordon Laboratories, Inc TITANIUM DIOXIDE 4000 mg/50mL E 20171231 21839-091_6f3d5cc8-cae0-47e5-be32-356236a5613f 21839-091 HUMAN OTC DRUG Waterblock Solar SPF 30 Homosalate, Octinoxate, Octisalate, Octocrylene, and Oxybenzone LIQUID TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part352 Gordon Laboratories, Inc HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 12.5; 9.4; 6.25; 12.5; 6.25 mL/125mL; mL/125mL; mL/125mL; mL/125mL; mL/125mL E 20171231 21839-101_b9f20f8a-78d0-4269-9b4a-43ed1281017a 21839-101 HUMAN OTC DRUG Multivitamin Bodyblock SPF 20 Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part352 Gordon Laboratories, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.5; 9.4; 6.25; 3.75 mL/125mL; mL/125mL; mL/125mL; mL/125mL E 20171231 21839-111_abc25671-26c1-4ed3-a027-8c6e16bb0ec9 21839-111 HUMAN OTC DRUG FACEBLOCK SPF30 SUPER SENSITIVE Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20051109 OTC MONOGRAPH NOT FINAL part352 Gordon Laboratories, Inc TITANIUM DIOXIDE; ZINC OXIDE 3.35; 4.6 mL/50mL; mL/50mL E 20171231 22100-001_fae61354-a16e-4081-9197-646807f03910 22100-001 HUMAN PRESCRIPTION DRUG Healing Waters White Tea Pear Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g E 20171231 22100-002_8ec3b010-6578-4f5a-a7a0-69334d95fb56 22100-002 HUMAN PRESCRIPTION DRUG Healing Waters Peach Nectarine Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g E 20171231 22100-003_8a25c4bf-fc89-4547-b991-f5b9f17f2f89 22100-003 HUMAN PRESCRIPTION DRUG Healing Waters Lemon Verbena Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g E 20171231 22100-004_5c570163-c35d-4697-8224-f4bf3b4296c2 22100-004 HUMAN PRESCRIPTION DRUG Healing Waters Aloe Cucumber Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g E 20171231 22100-005_e6a1ee9b-88ab-4907-a6a5-a4ef0ece5fb6 22100-005 HUMAN PRESCRIPTION DRUG Healing Waters Cotton Blossom Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g E 20171231 22100-006_2922a287-cf69-4207-87c1-61cd12d4512d 22100-006 HUMAN PRESCRIPTION DRUG Healing Waters Violet Rose Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g E 20171231 22100-007_9e20bee7-0480-40a3-b6b9-190360e5562f 22100-007 HUMAN PRESCRIPTION DRUG Healing Waters Sweet Pea Lily Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 Ningbo Meiduo General Products Co., Ltd ALCOHOL 60 g/100g E 20171231 22100-014_a43668a5-02eb-42c4-aab0-ce54ec72a4be 22100-014 HUMAN OTC DRUG Healing Waters Clean Cotton Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20110407 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g E 20171231 22100-015_5880e893-4641-4690-981c-f722ca8a9419 22100-015 HUMAN OTC DRUG Healing Waters Cucumber Melon Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20110507 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g E 20171231 22100-016_a50664f7-474b-47e4-b437-d026c3d50e60 22100-016 HUMAN OTC DRUG Healing Waters Island Nectar Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20110507 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g E 20171231 22100-017_1f047926-ed0f-46c5-afd7-41d6aad9f8f6 22100-017 HUMAN OTC DRUG Healing Waters Sweet Pea Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20110507 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g E 20171231 22100-020_336dbb3c-6980-4614-9a66-821b0615ac84 22100-020 HUMAN OTC DRUG Sweet Pea Waterless Anti-Antibateria Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110407 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g E 20171231 22100-021_de32610a-5b5c-4ec6-b44e-205980fdf206 22100-021 HUMAN OTC DRUG Fresh Lavender Waterless Anti-Antibateria Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110418 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g E 20171231 22100-022_6f1c4f48-3aac-4651-9f71-93b229124f6d 22100-022 HUMAN OTC DRUG Cotton Blossom Waterless Anti-Antibateria Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g E 20171231 22100-023_01cd56a7-d2f7-4d15-858e-569679b08e40 22100-023 HUMAN OTC DRUG Cherry Blossom Waterless Anti-Antibateria Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110407 OTC MONOGRAPH NOT FINAL part333E NINGBO MEIDUO GENERAL PRODUCTS CO., LTD ALCOHOL 62 g/100g E 20171231 22201-1001_ce94e0ae-7ad7-49cf-b1c3-0299d8e9a9c4 22201-1001 HUMAN OTC DRUG Charmzone Natural Skinade BB Cream (SPF20 PA) TITANIUM DIOXIDE ZINC OXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 CHARMZONE CO LTD TITANIUM DIOXIDE; ZINC OXIDE 3.11; .777 mL/50mL; mL/50mL E 20171231 22201-2001_5d7f20ed-e64b-4c80-8695-e27eeaa0c533 22201-2001 HUMAN OTC DRUG Charmzone ALBATROSS Powder Sun (SPF41 PA) OCTINOXATE OCTISALATE ZINC OXIDE TITANIUM DIOXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 CHARMZONE CO LTD OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 4.91; 3.15; 2.33; 1.225 mL/70mL; mL/70mL; mL/70mL; mL/70mL E 20171231 22201-3001_b840d9bc-0eb0-48c8-a387-180e18769754 22201-3001 HUMAN OTC DRUG Charmzone Natural Skinade BB Cream (SPF20 PA) TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 CHARMZONE CO LTD TITANIUM DIOXIDE; ZINC OXIDE 3.11; .777 mL/50mL; mL/50mL E 20171231 22408-000_0d9c3793-0976-42de-bea4-13fd06867737 22408-000 HUMAN OTC DRUG SUKANG Alcohol Prep Pads Medium ALCOHOL LIQUID TOPICAL 20130213 OTC MONOGRAPH FINAL part333E Taizhou Kanglin Health Protection Products Co Ltd ALCOHOL 70 g/100g E 20171231 22408-001_8b7de57c-cb56-4d79-b39b-6b27b845e14f 22408-001 HUMAN OTC DRUG SUKANG BZK Antiseptic Towelette BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130213 OTC MONOGRAPH FINAL part333E Taizhou Kanglin Health Protection Products Co Ltd BENZALKONIUM CHLORIDE .13 g/100g E 20171231 22431-012_85cd46d0-0b2c-45d9-8f65-4658a7a2c952 22431-012 HUMAN OTC DRUG ARCTIC ICE ANALGESIC MENTHOL GEL TOPICAL 20151211 OTC MONOGRAPH NOT FINAL part348 Blue Cross Laboratories, Inc. MENTHOL 1 g/100g N 20181231 22431-014_1f4b81a9-f90d-4f4c-973d-7f54e498ab8d 22431-014 HUMAN OTC DRUG ARCTIC ICE pain relieving MENTHOL GEL TOPICAL 20170223 OTC MONOGRAPH NOT FINAL part348 Blue Cross Laboratories, Inc. MENTHOL 2 g/100g N 20181231 22431-020_605d28cb-3c08-355c-e053-2a91aa0af312 22431-020 HUMAN OTC DRUG 1.8oz Armstrong Hand Sanitizer with Aloe Vera and Vitamin E ALCOHOL GEL TOPICAL 20171025 OTC MONOGRAPH NOT FINAL part333A BLUE CROSS LABORATORIES, INC. ALCOHOL 65 mL/100mL N 20181231 22431-111_6ff08068-2e27-43ca-b148-65721dd5cc2e 22431-111 HUMAN OTC DRUG Blue Cross Laboratories Hand Rx Ethyl Alcohol LIQUID TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part333E Blue Cross Laboratories ALCOHOL 62 mL/100mL N 20181231 22431-123_38a0bf3e-b1d1-3d70-e054-00144ff88e88 22431-123 HUMAN OTC DRUG MED AID CHEST RUB Menthol and Camphor and Eucalyptus Oil OINTMENT TOPICAL 20150811 OTC MONOGRAPH NOT FINAL part348 Blue Cross Laboratories, Inc. MENTHOL; CAMPHOR (SYNTHETIC); EUCALYPTUS OIL 1; 4.7; 1 g/100g; g/100g; g/100g N 20181231 22431-124_feba76fe-cb07-4ded-9536-c3e484a0d35c 22431-124 HUMAN OTC DRUG Epsom Salts Relief Magnesium Sulfate Heptahydrate GRANULE ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Blue Cross Laboratories, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 100 g/100g N 20181231 22431-125_5082eb7e-afcf-44da-846c-a018544262d1 22431-125 HUMAN OTC DRUG Med Aid Chest Rub Menthol,Camphor, Eucalyptus Oil OINTMENT TOPICAL 20120330 OTC MONOGRAPH NOT FINAL part348 Blue Cross Laboratories, Inc. MENTHOL; CAMPHOR (SYNTHETIC); EUCALYPTUS OIL 1; 4.7; 1.2 g/100g; g/100g; g/100g N 20181231 22431-126_d45a3ebb-a36a-416a-8232-737477f6d7c0 22431-126 HUMAN OTC DRUG Med Aid Chest Rub Menthol,Camphor, Eucalyptus Oil OINTMENT TOPICAL 20120330 OTC MONOGRAPH FINAL part341 Blue Cross Laboratories, Inc. MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC); EUCALYPTUS OIL 1; 4.7; 1 g/100g; g/100g; g/100g N 20181231 22431-130_ecc987d3-2c0c-4600-9fae-eac13ff0fc42 22431-130 HUMAN OTC DRUG Assured Vaporizing Chest Rub Menthol, Camphor, Eucalyptus Oil OINTMENT TOPICAL 20120106 OTC MONOGRAPH FINAL part341 Blue Cross Laboratories, Inc. MENTHOL; CAMPHOR (SYNTHETIC); EUCALYPTUS OIL 1; 4.7; 1 g/100g; g/100g; g/100g N 20181231 22431-132_0fc4ce37-bc88-4011-b41d-7fcce9efec50 22431-132 HUMAN OTC DRUG Hand Sanitizer Lemon Scent Hand Rx Ethyl Alcohol GEL TOPICAL 20140819 OTC MONOGRAPH NOT FINAL part333E Blue Cross Laboratories, Inc. ALCOHOL 62 g/100mL N 20181231 22431-248_1b65efdc-a979-4990-ba8c-97b6cb0d4047 22431-248 HUMAN OTC DRUG Relief Epsom Salt Magnesium Sulfate Heptahydrate GRANULE ORAL 20170822 OTC MONOGRAPH NOT FINAL part334 BLUE CROSS LABORATORIES, INC. MAGNESIUM SULFATE HEPTAHYDRATE 3.63 kg/3.63kg N 20181231 22431-328_d9823d03-31e9-4d16-874d-81669bfda604 22431-328 HUMAN OTC DRUG Body Guard Sport Clear Aluminum Zirconium STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Blue Cross Laboratories ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 70 g/100g N 20181231 22431-359_d4177358-a226-4e6d-8472-0c9e6e0414a6 22431-359 HUMAN OTC DRUG Relief Soothing Bath Treatment Colloidal Oatmeal GRANULE, EFFERVESCENT TOPICAL 20100917 OTC MONOGRAPH FINAL part347 Blue Cross Laboratories, Inc. OATMEAL 1 g/g N 20181231 22431-580_ae8accc4-edb4-40c9-9b32-d19b2cb816ad 22431-580 HUMAN OTC DRUG Dry Scalp Care Dandruff MD Pyrithizone Zinc SHAMPOO TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part358H Blue Coss Laboratories, Inc. PYRITHIONE ZINC 1 mL/100mL N 20181231 22431-581_251b4dc4-e66e-44d0-894f-1859473e2e4e 22431-581 HUMAN OTC DRUG Hand Sanitizer Hand Rx Ethyl Alcohol LIQUID TOPICAL 20101012 OTC MONOGRAPH NOT FINAL part333E Blue Cross Laboratories, Inc. ALCOHOL 62 g/100mL N 20181231 22431-582_b2b5bd06-32f8-4ca0-8ee2-075b40a19ff9 22431-582 HUMAN OTC DRUG Clear Antibacterial Hand Triclosan SOAP TOPICAL 20140925 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc TRICLOSAN .15 g/100mL N 20181231 22431-583_8c9e3826-f151-4778-9799-950269a93ac7 22431-583 HUMAN OTC DRUG Safety Gold Antibacterial Hand triclosan LIQUID TOPICAL 20140925 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc TRICLOSAN .15 g/100mL N 20181231 22431-600_267b7d9d-34f5-487b-a40b-f1043e2fa4cd 22431-600 HUMAN OTC DRUG Arctic Ice Analgesic Menthol GEL TOPICAL 20150916 OTC MONOGRAPH FINAL part341 Blue Cross Labs MENTHOL 1 g/100g N 20181231 22431-641_88e9ab59-3b83-47cf-ab1a-50558432f923 22431-641 HUMAN OTC DRUG Antiperspirant Maximum Security Aluminum Zirconium tetrachlorohydrex STICK TOPICAL 20110607 OTC MONOGRAPH FINAL part350 Blue Cross Labs ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 6.02 g/70g N 20181231 22431-700_d63e34f8-d58d-42d0-9024-73bfdd4a5913 22431-700 HUMAN OTC DRUG Stay Dry Deodorant Roll On Aluminum Chlorohydrate STICK TOPICAL 20161202 OTC MONOGRAPH FINAL part350 Blue Cros s Laboratories , Inc. ALUMINUM CHLOROHYDRATE 25 g/100mL N 20181231 22431-701_cc715147-d10a-4ab9-8a0c-ef3534e86f88 22431-701 HUMAN OTC DRUG Antibacterial Bar Blue Cross Chloroxylenol SOAP TOPICAL 20161206 OTC MONOGRAPH NOT FINAL part333A Blue Cross Laboratories, Inc CHLOROXYLENOL .3 g/100g N 20181231 22557-001_5b32633a-55fe-9979-e053-2a91aa0a6671 22557-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020101 NDA NDA205840 AGP LLC OXYGEN 99 L/100L N 20181231 22557-002_5c31ef3f-7498-4b15-8c42-7a6213aad111 22557-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20020101 NDA NDA205839 AGP LLC NITROGEN 99 L/100L N 20181231 22607-012_59c0c9d5-2a0a-4591-984a-039b3fdc6194 22607-012 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170322 ANDA ANDA206996 Mitim S.r.l. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 22607-034_59c0c9d5-2a0a-4591-984a-039b3fdc6194 22607-034 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170322 ANDA ANDA206996 Mitim S.r.l. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 22607-056_59c0c9d5-2a0a-4591-984a-039b3fdc6194 22607-056 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170322 ANDA ANDA206996 Mitim S.r.l. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 22607-679_68e829fe-50ce-4640-908b-2ec4b6ffbe9a 22607-679 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170320 ANDA ANDA207146 Mitim S.r.l. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 36; 4.5 g/180mL; g/180mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 22607-698_9bd988ab-59ea-4274-a17c-308c580692b3 22607-698 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170731 ANDA ANDA207147 Mitim S.r.l. OXACILLIN SODIUM 1 g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 22607-699_9bd988ab-59ea-4274-a17c-308c580692b3 22607-699 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170731 ANDA ANDA207147 Mitim S.r.l. OXACILLIN SODIUM 2 g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 22700-001_c6e0d4d6-efa8-47ef-9d23-099349ce8c95 22700-001 HUMAN OTC DRUG Covergirl cgsmoothers BB Tinted Moisturizer Broad Spectrum SPF 21 (all shades) Octinoxate and Zinc Oxide CREAM TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Noxell Corporation OCTINOXATE; ZINC OXIDE 6; 3 g/100mL; g/100mL N 20181231 22700-002_90acc0e0-a83f-47a9-b22d-2bc1b6979f88 22700-002 HUMAN OTC DRUG Gucci Face Lustrous Glow Foundation Broadspectrum SPF 25 (all shades) Octinoxate and Titanium Dioxide LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Noxell Corporation OCTINOXATE; TITANIUM DIOXIDE 3.49; 2.52 g/100mL; g/100mL N 20181231 22700-084_8ca4be05-d1d8-480d-848b-933391835e62 22700-084 HUMAN OTC DRUG Covergirl Aquasmooth Broadspectrum SPF 20 All shades Titanium Dioxide CREAM TOPICAL 20140315 OTC MONOGRAPH NOT FINAL part352 Noxell Corporation TITANIUM DIOXIDE 9 g/100g N 20181231 22700-098_37c7c24a-80b3-44cd-8372-d31afd1bf1d2 22700-098 HUMAN OTC DRUG Covergirl Advanced Radiance Age Defying Makeup plus Sunscreen SPF 10 (All shades) Octinoxate and Titanium Dioxide LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Noxell OCTINOXATE; TITANIUM DIOXIDE 20; 50 mg/mL; mg/mL N 20181231 22700-111_8e3abe6f-8211-4c83-9b1a-bc5a8e3cc021 22700-111 HUMAN OTC DRUG Covergirl plus Olay SimplyAgeless Foundation Broadspectrum SPF 22 (All shades) Titanium Dioxide CREAM TOPICAL 20120801 20180416 OTC MONOGRAPH NOT FINAL part352 Noxell TITANIUM DIOXIDE 49 mg/g E 20171231 22700-127_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-127 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 805 Ivory Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-128_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-128 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 810 Classic Ivory Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-129_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-129 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 820 Creamy Natural Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-130_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-130 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 825 Buff Beige Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-131_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-131 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 832 Nude Beige Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-132_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-132 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 840 Natural Beige Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-133_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-133 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 842 Medium Beige Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-134_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-134 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 845 Warm Beige Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-135_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-135 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 850 Creamy Beige Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-136_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-136 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 855 Soft Honey Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-137_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-137 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 857 Golden Tan Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-138_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-138 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 860 Classic Tan Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-139_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-139 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 865 Tawny Ensulizole LIQUID TOPICAL 20120625 20191231 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-140_3cea8fca-9642-432a-8c4e-70b8616baa1b 22700-140 HUMAN OTC DRUG Covergirl Outlast Stay Fabulous 3in1 Foundation Broad spectrum SPF 20 - 875 Soft Sable Ensulizole LIQUID TOPICAL 20120625 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-141_c81d08ef-008e-4866-9637-22a192945ca2 22700-141 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q800 Sand Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-142_c81d08ef-008e-4866-9637-22a192945ca2 22700-142 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q805 Amber Glow Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-143_c81d08ef-008e-4866-9637-22a192945ca2 22700-143 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q810 Classic Bronze Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-144_c81d08ef-008e-4866-9637-22a192945ca2 22700-144 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q815 Brulee Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-145_c81d08ef-008e-4866-9637-22a192945ca2 22700-145 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q820 Toffee Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-146_c81d08ef-008e-4866-9637-22a192945ca2 22700-146 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q825 Golden Honey Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-147_c81d08ef-008e-4866-9637-22a192945ca2 22700-147 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q830 Soft Copper Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-148_c81d08ef-008e-4866-9637-22a192945ca2 22700-148 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q835 Mocha Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-149_c81d08ef-008e-4866-9637-22a192945ca2 22700-149 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q840 Almond Glow Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-150_c81d08ef-008e-4866-9637-22a192945ca2 22700-150 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q845 Warm Caramel Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-151_c81d08ef-008e-4866-9637-22a192945ca2 22700-151 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q850 Sheer Espresso Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-152_c81d08ef-008e-4866-9637-22a192945ca2 22700-152 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q855 Spicy Brown Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-153_c81d08ef-008e-4866-9637-22a192945ca2 22700-153 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q860 Rich Mink Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-154_c81d08ef-008e-4866-9637-22a192945ca2 22700-154 HUMAN OTC DRUG Covergirl Queen Collection All Day Flawless 3in1 Foundation Broad Spectrum SPF 20 - Q865 True Ebony Ensulizole LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Noxell ENSULIZOLE .03 mg/mL N 20181231 22700-155_f028392a-7674-4a05-9eac-39cfd9a7eb39 22700-155 HUMAN OTC DRUG Covergirl plus Olay Simply Ageless Foundation plus Titanium Dioxide Sunscreen Broad Spectrum SPF 28 (All shades) Titanium Dioxide CREAM TOPICAL 20150706 OTC MONOGRAPH NOT FINAL part352 Noxell Corporation TITANIUM DIOXIDE 4.9 mg/.1g N 20181231 22700-200_497a0956-ee79-4ff0-b837-72a9aca5a7a8 22700-200 HUMAN OTC DRUG Covergirl Vitalist Healthy Foundation with Vitamins plus Ensulizole Sunscreen Broad Spectrum SPF 20 (All shades) Ensulizole LIQUID TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Noxell Corporation ENSULIZOLE 3 g/100mL N 20181231 22742-003_879690c5-09d0-4b22-9bbf-33408baad48e 22742-003 HUMAN OTC DRUG SHANGHAI SHANG SHI ZHI TONG GAO PAIN RELIEVING CAMPHOR, MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20090309 OTC MONOGRAPH NOT FINAL part348 SHANGHAI LEI YUN SHANG PHARMACEUTICAL CO LTD CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 10.28; 15.43 1/1; 1/1; 1/1 N 20181231 22840-0033_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0033 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides farinae CONCENTRATE INTRADERMAL; SUBCUTANEOUS 20100203 BLA BLA101834 Greer Laboratories, Inc. DERMATOPHAGOIDES FARINAE 5000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 22840-0034_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0034 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides farinae CONCENTRATE INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 20100203 BLA BLA101834 Greer Laboratories, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 22840-0035_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0035 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides pteronyssinus CONCENTRATE INTRADERMAL; SUBCUTANEOUS 20100203 BLA BLA101835 Greer Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 5000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 22840-0036_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0036 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides pteronyssinus CONCENTRATE INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 20100203 BLA BLA101835 Greer Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 22840-0037_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0037 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides farinae and Dermatophagoides pteronyssinus CONCENTRATE INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 20100203 BLA BLA101834 Greer Laboratories, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 5000; 5000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 22840-0038_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0038 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides farinae CONCENTRATE INTRADERMAL; SUBCUTANEOUS 20100203 BLA BLA101834 Greer Laboratories, Inc. DERMATOPHAGOIDES FARINAE 30000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 22840-0039_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0039 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides pteronyssinus CONCENTRATE INTRADERMAL; SUBCUTANEOUS 20100203 BLA BLA101835 Greer Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 30000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 22840-0040_e1d71870-b466-498d-8e9f-292f060d1a92 22840-0040 HUMAN PRESCRIPTION DRUG Allergenic Extracts Standardized Mite Dermatophagoides farinae and Dermatophagoides pteronyssinus CONCENTRATE INTRADERMAL; SUBCUTANEOUS 20100203 BLA BLA101834 Greer Laboratories, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 15000; 15000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 22840-0100_6258b68a-7dfd-1fe5-e053-2991aa0a9b1e 22840-0100 STANDARDIZED ALLERGENIC Standardized Cat Hair Allergenic Extract Felis catus SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19920924 BLA BLA103397 Greer Laboratories, Inc. FELIS CATUS DANDER; FELIS CATUS SKIN 5000; 5000 [BAU]/mL; [BAU]/mL Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0101_6258b68a-7dfd-1fe5-e053-2991aa0a9b1e 22840-0101 STANDARDIZED ALLERGENIC Standardized Cat Hair Allergenic Extract Felis catus SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19920924 BLA BLA103397 Greer Laboratories, Inc. FELIS CATUS DANDER; FELIS CATUS SKIN 10000; 10000 [BAU]/mL; [BAU]/mL Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0200_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0200 STANDARDIZED ALLERGENIC Standardized Bermuda Grass Pollen Cynodon dactylon SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101836 Greer Laboratories, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0201_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0201 STANDARDIZED ALLERGENIC Standardized Kentucky (June) Bluegrass Pollen Poa pratensis SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101837 Greer Laboratories, Inc. POA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0202_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0202 STANDARDIZED ALLERGENIC Standardized Kentucky (June) Bluegrass Pollen Poa pratensis SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101837 Greer Laboratories, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0203_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0203 STANDARDIZED ALLERGENIC Standardized Meadow Fescue Pollen Festuca elatior SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101838 Greer Laboratories, Inc. FESTUCA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0204_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0204 STANDARDIZED ALLERGENIC Standardized Meadow Fescue Pollen Festuca elatior SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101838 Greer Laboratories, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0205_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0205 STANDARDIZED ALLERGENIC Standardized Orchard Grass Pollen Dactylis glomerata SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101839 Greer Laboratories, Inc. DACTYLIS GLOMERATA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0206_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0206 STANDARDIZED ALLERGENIC Standardized Orchard Grass Pollen Dactylis glomerata SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101839 Greer Laboratories, Inc. DACTYLIS GLOMERATA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0207_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0207 STANDARDIZED ALLERGENIC Standardized Redtop Pollen Agrostis alba SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101840 Greer Laboratories, Inc. AGROSTIS GIGANTEA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0208_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0208 STANDARDIZED ALLERGENIC Standardized Redtop Pollen Agrostis alba SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101840 Greer Laboratories, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0209_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0209 STANDARDIZED ALLERGENIC Standardized Perennial Ryegrass Pollen Lolium perenne SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101841 Greer Laboratories, Inc. LOLIUM PERENNE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0210_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0210 STANDARDIZED ALLERGENIC Standardized Perennial Ryegrass Pollen Lolium perenne SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101841 Greer Laboratories, Inc. LOLIUM PERENNE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0211_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0211 STANDARDIZED ALLERGENIC Standardized Sweet Vernal Grass Pollen Anthoxanthum odoratum SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101842 Greer Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0212_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0212 STANDARDIZED ALLERGENIC Standardized Sweet Vernal Grass Pollen Anthoxanthum odoratum SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101842 Greer Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0213_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0213 STANDARDIZED ALLERGENIC Standardized Timothy Pollen Phleum pratense SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101843 Greer Laboratories, Inc. PHLEUM PRATENSE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0214_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0214 STANDARDIZED ALLERGENIC Standardized Timothy Pollen Phleum pratense SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101843 Greer Laboratories, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0215_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0215 STANDARDIZED ALLERGENIC Timothy-Orchard Standardized Grass Pollen Mix Phleum pratense and Dactylis glomerata SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101843 Greer Laboratories, Inc. DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 50000; 50000 [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0216_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0216 STANDARDIZED ALLERGENIC K-O-T Standardized Grass Pollen Mix Poa pratensis, Dactylis glomerata and Phleum pratense SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101837 Greer Laboratories, Inc. POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 3333.333; 3333.333; 3333.333 [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0217_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0217 STANDARDIZED ALLERGENIC K-O-T Standardized Grass Pollen Mix Poa pratensis, Dactylis glomerata and Phleum pratense SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101837 Greer Laboratories, Inc. POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 33333.333; 33333.333; 33333.333 [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0218_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0218 STANDARDIZED ALLERGENIC K-O-R-T Standardized Grass Pollen Mix Poa pratensis, Dactylis glomerata, Agrostis alba and Phleum pratense SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101837 Greer Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 2500; 2500; 2500; 2500 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0219_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0219 STANDARDIZED ALLERGENIC K-O-R-T Standardized Grass Pollen Mix Poa pratensis, Dactylis glomerata, Agrostis alba and Phleum pratense SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101837 Greer Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 25000; 25000; 25000; 25000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0220_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0220 STANDARDIZED ALLERGENIC K-O-R-T and Sweet Vernal Standardized Grass Pollen Mix Poa pratensis, Dactylis glomerata, Agrostis alba, Phleum pratense, and Anthoxanthum odoratum SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101837 Greer Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 2000; 2000; 2000; 2000; 2000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0221_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0221 STANDARDIZED ALLERGENIC K-O-R-T and Sweet Vernal Standardized Grass Pollen Mix Poa pratensis, Dactylis glomerata, Agrostis alba, Phleum pratense, and Anthoxanthum odoratum SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101837 Greer Laboratories, Inc. AGROSTIS GIGANTEA POLLEN; POA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 20000; 20000; 20000; 20000; 20000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0222_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0222 STANDARDIZED ALLERGENIC 7 Standardized Grass Pollen Mix Poa pratensis, Festuca elatior, Dactylis glomerata, Lolium perenne, Agrositis alba, Anthoxanthum odoratum, and Phleum pratense SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101837 Greer Laboratories, Inc. POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM PERENNE POLLEN; FESTUCA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714; 1428.5714 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0223_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0223 STANDARDIZED ALLERGENIC 7 Standardized Grass Pollen Mix Poa pratensis, Festuca elatior, Dactylis glomerata, Lolium perenne, Agrositis alba, Anthoxanthum odoratum, and Phleum pratense SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101837 Greer Laboratories, Inc. POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM PERENNE POLLEN; FESTUCA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 14285.714; 14285.714; 14285.714; 14285.714; 14285.714; 14285.714; 14285.714 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0224_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0224 STANDARDIZED ALLERGENIC T-O-S Standardized Grass Pollen Mix Phleum pratense, Dactylis glomerata and Anthoxanthum odoratum SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101843 Greer Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 3333.333; 3333.333; 3333.333 [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0226_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0226 STANDARDIZED ALLERGENIC Timothy-Orchard Standardized Grass Pollen Mix Phleum pratense and Dactylis glomerata SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101843 Greer Laboratories, Inc. DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 5000; 5000 [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0227_60b8218f-84f1-1acc-e053-2991aa0a2795 22840-0227 STANDARDIZED ALLERGENIC T-O-S Standardized Grass Pollen Mix Phleum pratense, Dactylis glomerata and Anthoxanthum odoratum SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19680915 BLA BLA101843 Greer Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN 33333.333; 33333.333; 33333.333 [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0300_60b52a1c-8f5f-2302-e053-2991aa0a601a 22840-0300 NON-STANDARDIZED ALLERGENIC Short Ragweed Pollen Ambrosia artemisiifolia SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19810915 BLA BLA101844 Greer Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN .05 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22840-0301_60b52a1c-8f5f-2302-e053-2991aa0a601a 22840-0301 NON-STANDARDIZED ALLERGENIC Short and Giant Ragweed Pollen Mix Ambrosia artemisiifolia and Ambrosia trifida SOLUTION INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS 19810915 BLA BLA101844 Greer Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN .025; .025 g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 22884-8103_0332777c-331c-4cfe-b220-6f7315172528 22884-8103 HUMAN OTC DRUG Pre-Scrub II Surgical Hand Scrub Chlorhexidine Gluconate Solution SOLUTION TOPICAL 19890301 NDA NDA019822 BioMed Systems, Inc. CHLORHEXIDINE GLUCONATE 1 mg/25mL E 20171231 22955-012_93390d23-4701-4bcb-8e8a-1abb507368a7 22955-012 HUMAN OTC DRUG Allergy Buster Capsicum annuum, Urtica dioica SPRAY NASAL 20081231 UNAPPROVED HOMEOPATHIC SiCap Industries LLC RED PEPPER; URTICA DIOICA 5; 3 [hp_X]/20mL; [hp_X]/20mL E 20171231 22955-013_7be3b9f3-22c4-460d-82ec-cac81980a20f 22955-013 HUMAN OTC DRUG Headache Buster Capsicum annuum, pyrethrum parthenium, mentholum SPRAY NASAL 20081231 UNAPPROVED HOMEOPATHIC SiCap Industries LLC RED PEPPER; TANACETUM PARTHENIUM; MENTHOL 4; 3; 2 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL E 20171231 22955-014_de4d75dd-fff7-47ff-ba87-a3362f6200c4 22955-014 HUMAN OTC DRUG Sinus Buster Capsicum Annuum SPRAY NASAL 20081231 UNAPPROVED HOMEOPATHIC SiCap Industries LLC RED PEPPER 4 [hp_X]/20mL E 20171231 22955-015_ad41861c-360a-495d-8993-c3ae590c98e3 22955-015 HUMAN OTC DRUG Sinus Buster Mild Formula Capsicum Annuum SPRAY NASAL 20081231 UNAPPROVED HOMEOPATHIC SiCap Industries LLC RED PEPPER 5 [hp_X]/20mL E 20171231 22955-016_40c0a800-3c47-4b8c-9ad1-6e4dbca51a1b 22955-016 HUMAN OTC DRUG Cold Buster Pelargonium sidoides SYRUP ORAL 20100701 UNAPPROVED HOMEOPATHIC SiCap Industries LLC PELARGONIUM SIDOIDES ROOT 24 [hp_X]/120mL E 20171231 23021-001_413ca6ab-9c16-4bc3-9e27-375431ee830a 23021-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19460101 UNAPPROVED MEDICAL GAS Cranston Welding Supply Company OXYGEN 99 L/100L E 20171231 23104-5010_a091b036-988a-4170-a21d-6c003b5b1519 23104-5010 HUMAN OTC DRUG Becca Mineral SPF Primer Zinc Oxide CREAM TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part352 Cosmetic Developments Limited ZINC OXIDE 17 mL/100mL E 20171231 23155-001_24529d80-523d-4287-b281-4c0ae570c22f 23155-001 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Heritage Pharmaceuticals Inc HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 23155-002_24529d80-523d-4287-b281-4c0ae570c22f 23155-002 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Heritage Pharmaceuticals Inc HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 23155-003_24529d80-523d-4287-b281-4c0ae570c22f 23155-003 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Heritage Pharmaceuticals Inc HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 23155-004_24529d80-523d-4287-b281-4c0ae570c22f 23155-004 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Heritage Pharmaceuticals Inc HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 23155-005_d1496e17-f164-4f85-8242-5ff772d25cdb 23155-005 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20070716 ANDA ANDA073262 Heritage Pharmaceuticals Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 23155-006_d1496e17-f164-4f85-8242-5ff772d25cdb 23155-006 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20070716 ANDA ANDA073262 Heritage Pharmaceuticals Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 23155-008_062e5ef0-8604-4b96-8040-cd1e24ed372d 23155-008 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20150115 ANDA ANDA085182 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-008_52e007cf-3e7a-4f14-9ffb-eeb8111b69ce 23155-008 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20150201 ANDA ANDA085182 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-009_062e5ef0-8604-4b96-8040-cd1e24ed372d 23155-009 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20150115 ANDA ANDA085182 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-009_52e007cf-3e7a-4f14-9ffb-eeb8111b69ce 23155-009 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20150201 ANDA ANDA085182 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-010_50cc267d-ae19-4877-8729-97d754e5a497 23155-010 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100710 NDA NDA018851 Heritage Pharmaceuticals Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 23155-011_50cc267d-ae19-4877-8729-97d754e5a497 23155-011 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100730 NDA NDA018851 Heritage Pharmaceuticals Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 23155-013_47fae28b-5ae6-4604-9962-a8bf4f9f9584 23155-013 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20101105 ANDA ANDA040275 Heritage Pharmaceuticals Inc ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 23155-014_47fae28b-5ae6-4604-9962-a8bf4f9f9584 23155-014 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20101105 ANDA ANDA040275 Heritage Pharmaceuticals Inc ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 23155-015_47fae28b-5ae6-4604-9962-a8bf4f9f9584 23155-015 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20101105 ANDA ANDA040275 Heritage Pharmaceuticals Inc ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 23155-017_7361aa76-0341-4018-a1bd-e4d3776a85e1 23155-017 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20131018 NDA NDA050278 Heritage Pharmaceuticals Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 23155-018_7361aa76-0341-4018-a1bd-e4d3776a85e1 23155-018 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20131018 NDA NDA050278 Heritage Pharmaceuticals Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 23155-023_e121bb0f-e808-4afb-9a88-11daf61470ca 23155-023 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120629 ANDA ANDA204582 Heritage Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 23155-024_e121bb0f-e808-4afb-9a88-11daf61470ca 23155-024 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120629 ANDA ANDA204582 Heritage Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 23155-025_e121bb0f-e808-4afb-9a88-11daf61470ca 23155-025 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120629 ANDA ANDA204582 Heritage Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 23155-026_be4d583e-36fb-4cf0-b70c-d675c0b88254 23155-026 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20110107 ANDA ANDA071880 Heritage Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 23155-027_718017ec-d163-4fbe-9561-5fe6bae04db9 23155-027 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20110107 ANDA ANDA071881 Heritage Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 23155-028_50180aa1-ef99-4b28-a192-1f9fbee0c621 23155-028 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20120629 ANDA ANDA201336 Heritage Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 23155-029_50180aa1-ef99-4b28-a192-1f9fbee0c621 23155-029 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20120629 ANDA ANDA201336 Heritage Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 23155-030_50180aa1-ef99-4b28-a192-1f9fbee0c621 23155-030 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20120629 ANDA ANDA201336 Heritage Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 23155-035_e5602b36-0037-4f4d-9e7d-20f21524d2aa 23155-035 HUMAN PRESCRIPTION DRUG Moexipril hydrochloride and hydrochlorothiazide Moexipril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20140320 ANDA ANDA202150 Heritage Pharmaceuticals Inc. MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 7.5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-036_e5602b36-0037-4f4d-9e7d-20f21524d2aa 23155-036 HUMAN PRESCRIPTION DRUG Moexipril hydrochloride and hydrochlorothiazide Moexipril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20140320 ANDA ANDA202150 Heritage Pharmaceuticals Inc. MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 15; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-037_e5602b36-0037-4f4d-9e7d-20f21524d2aa 23155-037 HUMAN PRESCRIPTION DRUG Moexipril hydrochloride and hydrochlorothiazide Moexipril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20140320 ANDA ANDA202150 Heritage Pharmaceuticals Inc. MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 15; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-038_972af693-5b2f-484a-9398-8fd20ade3b43 23155-038 HUMAN PRESCRIPTION DRUG Paromomycin Sulfate Paromomycin Sulfate CAPSULE ORAL 20091022 ANDA ANDA065173 Heritage Pharmaceuticals Inc. PAROMOMYCIN SULFATE 250 mg/1 Antiprotozoal [EPC] N 20181231 23155-043_af1e112b-04b7-496a-8fe3-cca83183e9d9 23155-043 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20091029 ANDA ANDA077086 Heritage Pharmaceuticals Inc LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] N 20181231 23155-044_af1e112b-04b7-496a-8fe3-cca83183e9d9 23155-044 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20091029 ANDA ANDA077086 Heritage Pharmaceuticals Inc LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] N 20181231 23155-045_25cd9999-b321-4ffc-8f40-558a72d346b4 23155-045 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20101210 ANDA ANDA079237 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-046_b13d4f4a-b95a-4593-8a80-953da1df1c56 23155-046 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-046_d2805216-a90f-4695-8597-fdbf92f2d667 23155-046 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110103 ANDA ANDA040807 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-047_b13d4f4a-b95a-4593-8a80-953da1df1c56 23155-047 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-047_d2805216-a90f-4695-8597-fdbf92f2d667 23155-047 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110103 ANDA ANDA040807 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-048_b2a6bfb7-f59e-4b4f-a602-a5204cab248c 23155-048 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20131108 ANDA ANDA201964 HERITAGE PHARMACEUTICALS INC. FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 23155-049_b2a6bfb7-f59e-4b4f-a602-a5204cab248c 23155-049 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20131108 ANDA ANDA201964 HERITAGE PHARMACEUTICALS INC. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 23155-050_b2a6bfb7-f59e-4b4f-a602-a5204cab248c 23155-050 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20131108 ANDA ANDA201964 HERITAGE PHARMACEUTICALS INC. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 23155-051_03b66301-2ddd-4855-96cf-371b179c0810 23155-051 HUMAN PRESCRIPTION DRUG Nystatin Nystatin TABLET, COATED ORAL 20111031 ANDA ANDA062474 Heritage Pharmaceuticals Inc NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 23155-054_40e7d253-d2f4-41ec-bcb0-a01f580f8e86 23155-054 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET ORAL 20110315 ANDA ANDA200502 Heritage Pharmaceuticals Inc. NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 23155-055_40e7d253-d2f4-41ec-bcb0-a01f580f8e86 23155-055 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET ORAL 20110315 ANDA ANDA200502 Heritage Pharmaceuticals Inc. NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 23155-056_0cf7267b-2847-4f64-87c2-7aa21d7f474a 23155-056 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Heritage Pharmaceuticals Inc. GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 23155-057_0cf7267b-2847-4f64-87c2-7aa21d7f474a 23155-057 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Heritage Pharmaceuticals Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 23155-058_0cf7267b-2847-4f64-87c2-7aa21d7f474a 23155-058 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Heritage Pharmaceuticals Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 23155-059_718017ec-d163-4fbe-9561-5fe6bae04db9 23155-059 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20151015 ANDA ANDA071881 Heritage Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 40 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 23155-060_199837fb-147b-4251-a0db-08220c0d9045 23155-060 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide Tablet TABLET ORAL 20111115 ANDA ANDA079025 Heritage Pharmaceuticals Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-061_199837fb-147b-4251-a0db-08220c0d9045 23155-061 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20111115 ANDA ANDA079025 Heritage Pharmaceuticals Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-067_cbb77614-ed72-468a-b2bf-f9efc28a2470 23155-067 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride TABLET ORAL 20130217 ANDA ANDA040673 Heritage Pharmaceuticals Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 23155-068_cbb77614-ed72-468a-b2bf-f9efc28a2470 23155-068 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride TABLET ORAL 20130217 ANDA ANDA040673 Heritage Pharmaceuticals Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 23155-069_cbb77614-ed72-468a-b2bf-f9efc28a2470 23155-069 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride TABLET ORAL 20130217 ANDA ANDA040673 Heritage Pharmaceuticals Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 23155-070_65ec4518-1e51-4c7c-8be9-46fa6c79ac0f 23155-070 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20120115 ANDA ANDA040734 Heritage Pharmaceuticals Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20191231 23155-071_65ec4518-1e51-4c7c-8be9-46fa6c79ac0f 23155-071 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20120115 ANDA ANDA040734 Heritage Pharmaceuticals Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20191231 23155-097_e121bb0f-e808-4afb-9a88-11daf61470ca 23155-097 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120629 ANDA ANDA204582 Heritage Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 23155-102_b1bc2071-04bb-4555-aaa0-84d9b6126406 23155-102 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Heritage Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 23155-103_b1bc2071-04bb-4555-aaa0-84d9b6126406 23155-103 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Heritage Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 23155-104_b1bc2071-04bb-4555-aaa0-84d9b6126406 23155-104 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Heritage Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 23155-105_31945055-e1c9-4ecd-9ab0-944a377beefb 23155-105 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Heritage Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 23155-106_31945055-e1c9-4ecd-9ab0-944a377beefb 23155-106 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Heritage Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 23155-107_31945055-e1c9-4ecd-9ab0-944a377beefb 23155-107 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Heritage Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 23155-108_6fb8ce9c-b4b6-4672-ae31-f6aff6e92447 23155-108 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE, LIQUID FILLED ORAL 20080321 ANDA ANDA076740 Heritage NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 23155-110_a33756cb-a113-4488-be81-2e76c7edc990 23155-110 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Heritage Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 23155-111_a33756cb-a113-4488-be81-2e76c7edc990 23155-111 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Heritage Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 23155-112_a33756cb-a113-4488-be81-2e76c7edc990 23155-112 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Heritage Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 23155-113_a33756cb-a113-4488-be81-2e76c7edc990 23155-113 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Heritage Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 23155-114_a33756cb-a113-4488-be81-2e76c7edc990 23155-114 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Heritage Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 23155-115_0f436d5f-cbb7-4cbe-bdf8-3da3cbcd0430 23155-115 HUMAN PRESCRIPTION DRUG Glipizide and Metformin HCl Glipizide and Metformin HCl TABLET, FILM COATED ORAL 20100629 ANDA ANDA078728 Heritage Pharmaceuticals Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 23155-116_0f436d5f-cbb7-4cbe-bdf8-3da3cbcd0430 23155-116 HUMAN PRESCRIPTION DRUG Glipizide and Metformin HCl Glipizide and Metformin HCl TABLET, FILM COATED ORAL 20100629 ANDA ANDA078728 Heritage Pharmaceuticals Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 23155-117_0f436d5f-cbb7-4cbe-bdf8-3da3cbcd0430 23155-117 HUMAN PRESCRIPTION DRUG Glipizide and Metformin HCl Glipizide and Metformin HCl TABLET, FILM COATED ORAL 20100629 ANDA ANDA078728 Heritage Pharmaceuticals Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 23155-118_2000f2f6-7c00-44f8-8eb5-b7151f268c1e 23155-118 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20130529 ANDA ANDA091174 Heritage Pharmaceuticals Inc CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 23155-119_2000f2f6-7c00-44f8-8eb5-b7151f268c1e 23155-119 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20130529 ANDA ANDA091174 Heritage Pharmaceuticals Inc CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 23155-120_7e384b9b-12eb-40ad-9d0e-61b27c8e40bc 23155-120 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20120924 ANDA ANDA090779 Heritage Pharmaceuticals Inc. ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 23155-133_70752c46-6c7f-4d8a-86f2-501dd1cd4528 23155-133 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20120501 ANDA ANDA091605 Heritage Pharmaceuticals Inc. DOXYCYCLINE 50 mg/1 N 20181231 23155-134_70752c46-6c7f-4d8a-86f2-501dd1cd4528 23155-134 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20120501 ANDA ANDA091605 Heritage Pharmaceuticals Inc. DOXYCYCLINE 75 mg/1 N 20181231 23155-135_70752c46-6c7f-4d8a-86f2-501dd1cd4528 23155-135 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20120501 ANDA ANDA091605 Heritage Pharmaceuticals Inc. DOXYCYCLINE 100 mg/1 N 20181231 23155-136_70752c46-6c7f-4d8a-86f2-501dd1cd4528 23155-136 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20120501 ANDA ANDA091605 Heritage Pharmaceuticals Inc. DOXYCYCLINE 150 mg/1 N 20181231 23155-137_b13d4f4a-b95a-4593-8a80-953da1df1c56 23155-137 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20120629 ANDA ANDA040807 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-137_d2805216-a90f-4695-8597-fdbf92f2d667 23155-137 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110103 ANDA ANDA040807 Heritage Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 23155-140_7a24f8f1-17f8-493a-bede-37314c9681ee 23155-140 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20090620 ANDA ANDA079237 Heritage Pharmaceuticals Inc HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 23155-141_e0de0f9b-da0e-4d46-90a0-84a59434cb34 23155-141 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Delayed release Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20130430 ANDA ANDA200856 Heritage Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 75 mg/1 N 20181231 23155-142_e0de0f9b-da0e-4d46-90a0-84a59434cb34 23155-142 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Delayed release Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20130430 ANDA ANDA200856 Heritage Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 23155-143_e0de0f9b-da0e-4d46-90a0-84a59434cb34 23155-143 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Delayed release Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20130430 ANDA ANDA200856 Heritage Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 150 mg/1 N 20181231 23155-145_6e7d3064-3529-419b-9ed7-ead7dea87a4d 23155-145 HUMAN PRESCRIPTION DRUG Carisoprodol and Aspirin Carisoprodol and Aspirin TABLET ORAL 20110331 ANDA ANDA089594 Heritage Pharmaceuticals Inc. CARISOPRODOL; ASPIRIN 200; 325 mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE] CIV N 20181231 23155-146_38c1be27-f2a5-4381-8f77-b25523b528fc 23155-146 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20100614 ANDA ANDA075090 Heritage Pharmaceuticals, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 23155-147_dd54730a-fd0a-42ca-a857-65b31d6a83f4 23155-147 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20120730 ANDA ANDA202271 Heritage Pharmaceuticals Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 23155-148_dd54730a-fd0a-42ca-a857-65b31d6a83f4 23155-148 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20120730 ANDA ANDA202271 Heritage Pharmaceuticals Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 23155-149_dd54730a-fd0a-42ca-a857-65b31d6a83f4 23155-149 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20120730 ANDA ANDA202271 Heritage Pharmaceuticals Inc. ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 23155-160_4c2e7158-7f73-49c9-90dd-40aedd17ea06 23155-160 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION INTRAVENOUS 20120913 ANDA ANDA204618 Heritage Pharmaceuticals Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 23155-162_b299c33c-d74e-4a97-81d3-a6e6c08f428b 23155-162 HUMAN PRESCRIPTION DRUG Ibandronate sodium Ibandronate sodium INJECTION, SOLUTION INTRAVENOUS 20140904 ANDA ANDA203987 Heritage Pharmaceuticals Inc. IBANDRONATE SODIUM 3 mg/3mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 23155-166_1767c072-5ec5-4782-882b-4220cd546bb0 23155-166 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20140813 ANDA ANDA203521 Heritage Pharmaceuticals Inc. TRANEXAMIC ACID 1 g/10mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 23155-168_625dd101-67c5-40c3-8936-e4261c418611 23155-168 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20121213 ANDA ANDA090424 Heritage Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 23155-170_4dfaeff8-74f6-4675-a5c2-22d324ba5cd3 23155-170 HUMAN PRESCRIPTION DRUG Zoledronic acid Zoledronic acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20121220 ANDA ANDA201783 Heritage Pharmaceuticals Inc. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 23155-174_c8502841-19f1-4cc5-a0b8-44b82bb0636f 23155-174 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride Tablets TABLET, FILM COATED ORAL 20121019 ANDA ANDA202061 Heritage Pharmaceuticals Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 23155-178_4773f833-4d9d-4e7e-80be-2bb01c7a4d46 23155-178 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100607 ANDA ANDA075522 Heritage Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 23155-179_72a0512a-d877-41fe-a5f8-2c403dcd96ac 23155-179 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20120620 ANDA ANDA200771 Heritage Pharmaceuticals Inc. IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 23155-186_9d919ff0-bbe6-4b86-827d-d06d0cf9d68d 23155-186 HUMAN PRESCRIPTION DRUG Zoledronic acid Zoledronic acid INJECTION, SOLUTION INTRAVENOUS 20121220 ANDA ANDA201801 Heritage Pharmaceuticals Inc. ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 23155-191_2a309a73-1df4-406b-8ffa-5687e32726b4 23155-191 HUMAN PRESCRIPTION DRUG bupropion Hydrochloride bupropion Hydrochloride TABLET ORAL 20160819 ANDA ANDA206975 Heritage Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 23155-192_2a309a73-1df4-406b-8ffa-5687e32726b4 23155-192 HUMAN PRESCRIPTION DRUG bupropion Hydrochloride bupropion Hydrochloride TABLET ORAL 20160819 ANDA ANDA206975 Heritage Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 23155-193_1cbd27ea-8ba7-446e-a71f-42702a04c0ea 23155-193 HUMAN PRESCRIPTION DRUG COLISTIMETHATE SODIUM COLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121022 ANDA ANDA202359 Heritage Pharmaceuticals Inc. COLISTIMETHATE SODIUM 150 mg/4mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 23155-194_80edba1e-08f1-469b-9d61-f1123c9f9ab1 23155-194 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20101207 ANDA ANDA202644 Heritage Pharmaceuticals Inc. NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 23155-195_80edba1e-08f1-469b-9d61-f1123c9f9ab1 23155-195 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20101207 ANDA ANDA202644 Heritage Pharmaceuticals Inc. NIFEDIPINE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 23155-196_9bdc47e4-f8f2-41c6-9c9e-972486a498bf 23155-196 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130118 ANDA ANDA078945 Heritage Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 23155-201_f010c054-b43c-4fcd-8e5e-44f0131c37de 23155-201 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION INTRAVENOUS 20130204 ANDA ANDA202590 Heritage Pharmaceuticals Inc. LEVOFLOXACIN 25 mg/mL N 20181231 23155-213_83893525-cf78-4420-8447-07c1665dd000 23155-213 HUMAN PRESCRIPTION DRUG Gemcitabine hydrochloride Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20121022 ANDA ANDA202063 Heritage Pharmaceuticals Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 23155-214_83893525-cf78-4420-8447-07c1665dd000 23155-214 HUMAN PRESCRIPTION DRUG Gemcitabine hydrochloride Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20121022 ANDA ANDA202063 Heritage Pharmaceuticals Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 23155-216_75d8f995-38c9-408d-a217-f0343e4e7ba7 23155-216 HUMAN PRESCRIPTION DRUG CIDOFOVIR DIHYDRATE CIDOFOVIR DIHYDRATE INJECTION, SOLUTION INTRAVENOUS 20120806 ANDA ANDA202501 Heritage Pharmaceuticals Inc. CIDOFOVIR 375 mg/5mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient] N 20181231 23155-217_2ad44777-8786-4d5e-9eaf-547151369932 23155-217 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20131115 ANDA ANDA202275 Heritage Pharmaceuticals Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/4mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 23155-218_2ad44777-8786-4d5e-9eaf-547151369932 23155-218 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20131115 ANDA ANDA202275 Heritage Pharmaceuticals Inc. VANCOMYCIN HYDROCHLORIDE 1 g/8mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 23155-219_c2ef5b75-7bb1-4a61-924a-7530034da7f3 23155-219 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111125 ANDA ANDA202274 Heritage Pharmaceuticals Inc. VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 23155-220_d880e69b-a2fe-40a3-b7ed-8ac31d7363cd 23155-220 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCLORIDE VANCOMYCIN HYDROCLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111129 ANDA ANDA202464 Heritage Pharmaceuticals Inc. VANCOMYCIN HYDROCHLORIDE 10 g/80mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 23155-227_f8e46458-4b1e-409a-9b04-6770e8d85615 23155-227 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20130808 ANDA ANDA074891 Heritage Pharmaceuticals Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 23155-228_f8e46458-4b1e-409a-9b04-6770e8d85615 23155-228 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20130808 ANDA ANDA074891 Heritage Pharmaceuticals Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 23155-229_01f6224d-de9c-4e49-b999-544568ab7089 23155-229 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20140602 ANDA ANDA074889 Heritage Pharmaceuticals Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 23155-233_f70ca58f-363c-4913-bde6-8879fe74cb64 23155-233 HUMAN PRESCRIPTION DRUG Glyburide-Metformin Hydrochloride Glyburide-Metformin Hydrochloride TABLET ORAL 20121101 ANDA ANDA079009 Heritage Pharmaceuticals Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 23155-234_f70ca58f-363c-4913-bde6-8879fe74cb64 23155-234 HUMAN PRESCRIPTION DRUG Glyburide-Metformin Hydrochloride Glyburide-Metformin Hydrochloride TABLET ORAL 20121101 ANDA ANDA079009 Heritage Pharmaceuticals Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 23155-235_f70ca58f-363c-4913-bde6-8879fe74cb64 23155-235 HUMAN PRESCRIPTION DRUG Glyburide-Metformin Hydrochloride Glyburide-Metformin Hydrochloride TABLET ORAL 20121101 ANDA ANDA079009 Heritage Pharmaceuticals Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 23155-240_03ef0a23-4131-41a3-9e26-7a646b27dca1 23155-240 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20140103 ANDA ANDA204756 Heritage Pharmaceuticals Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 23155-244_1edfaf57-4c14-4c44-aa8b-3852b0cc4f22 23155-244 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20131126 ANDA ANDA204090 Heritage Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 23155-245_1edfaf57-4c14-4c44-aa8b-3852b0cc4f22 23155-245 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20131126 ANDA ANDA204090 Heritage Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 23155-246_83ee3359-9898-4ec8-b88c-40eba0e2fede 23155-246 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Heritage Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 23155-247_83ee3359-9898-4ec8-b88c-40eba0e2fede 23155-247 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Heritage Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 23155-248_83ee3359-9898-4ec8-b88c-40eba0e2fede 23155-248 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Heritage Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 23155-249_83ee3359-9898-4ec8-b88c-40eba0e2fede 23155-249 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Heritage Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 23155-250_83ee3359-9898-4ec8-b88c-40eba0e2fede 23155-250 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Heritage Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 23155-258_7a61e785-f066-426f-a887-af42de97d22c 23155-258 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20140801 ANDA ANDA202313 Heritage Pharmaceuticals Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 23155-259_abc7739f-0850-4a8b-a76f-f97a6b8762c3 23155-259 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20140801 ANDA ANDA202313 Heritage Pharmaceuticals Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] E 20171231 23155-261_03f56de6-304f-4d8d-ae0b-162959a0b1c7 23155-261 HUMAN PRESCRIPTION DRUG BiCNU CARMUSTINE KIT 20130404 NDA NDA017422 Heritage Pharmaceuticals Inc. N 20181231 23155-287_2deff184-58c6-4cae-9a90-b8b2b10a22e0 23155-287 HUMAN PRESCRIPTION DRUG acetazolamide acetazolamide TABLET ORAL 20130315 ANDA ANDA205530 Heritage Pharmaceuticals Inc. ACETAZOLAMIDE 125 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 23155-288_2deff184-58c6-4cae-9a90-b8b2b10a22e0 23155-288 HUMAN PRESCRIPTION DRUG acetazolamide acetazolamide TABLET ORAL 20130315 ANDA ANDA205530 Heritage Pharmaceuticals Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 23155-290_9fe655f3-92ce-4a56-96bc-b6c368cb6e28 23155-290 HUMAN PRESCRIPTION DRUG Amikacin Sulfate Amikacin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131224 ANDA ANDA204040 Heritage Pharmaceuticals Inc. AMIKACIN SULFATE 250 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 23155-291_6bf5f8d4-1a53-499c-8ef8-8b6c7383bc62 23155-291 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SYRUP ORAL 20130715 ANDA ANDA090102 Heritage Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 23155-292_80a66276-75fd-4847-a3ad-61effa57f7cf 23155-292 HUMAN PRESCRIPTION DRUG Cetirizine hydrochloride Cetirizine hydrochloride SOLUTION ORAL 20160902 ANDA ANDA078870 Heritage Pharmaceuticals Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 23155-293_7843fc23-96e2-4277-bfac-0bead344908e 23155-293 HUMAN PRESCRIPTION DRUG Lithium carbonate Lithium carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130330 ANDA ANDA205532 Heritage Pharmaceuticals Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 23155-294_55f365c4-482c-4f19-b3f2-ca6a869875cb 23155-294 HUMAN PRESCRIPTION DRUG Prochlorperazine Edisylate Prochlorperazine Edisylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20120326 ANDA ANDA204147 Heritage Pharmaceuticals Inc. PROCHLORPERAZINE EDISYLATE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 23155-313_d3711a9a-8bed-4824-a5f5-e2aba7261b4f 23155-313 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141219 ANDA ANDA202693 Heritage Pharmaceuticals Inc. ACETAZOLAMIDE SODIUM 500 mg/5mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 23155-317_5b0a757a-70cb-4963-8650-fb51955180ce 23155-317 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20160915 ANDA ANDA078909 Heritage Pharmaceuticals Inc. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 23155-340_9eaaccf4-555a-4dd6-ad8f-e946d3f499c8 23155-340 HUMAN PRESCRIPTION DRUG Rifampin Rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140818 ANDA ANDA204101 Heritage Pharmaceuticals Inc. RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 23155-362_bcbb84fe-a129-4e0d-88b7-f7fbddb75308 23155-362 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 20170101 ANDA ANDA209171 Heritage Pharmaceuticals Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 23155-377_aa3c50ec-5e31-4b39-aab2-d42040b31d56 23155-377 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140224 ANDA ANDA090424 Heritage Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 23155-378_4f9386bf-c714-47a0-b2f9-228dc0acb0a2 23155-378 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140219 ANDA ANDA078945 Heritage Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 23155-473_f0f43c51-7e98-4c25-be8c-4df969b83af2 23155-473 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAVENOUS 20140902 ANDA ANDA203428 Heritage Pharmaceuticals Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 23155-483_7e85d62c-003c-4dc5-9ea0-804d2f425546 23155-483 HUMAN PRESCRIPTION DRUG Gemcitabine hydrochloride Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20121022 ANDA ANDA202063 Heritage Pharmaceuticals Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 23155-484_7e85d62c-003c-4dc5-9ea0-804d2f425546 23155-484 HUMAN PRESCRIPTION DRUG Gemcitabine hydrochloride Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20121022 ANDA ANDA202063 Heritage Pharmaceuticals Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 23155-487_d877f7f0-ed9d-48b0-8ea0-11e672d27307 23155-487 HUMAN PRESCRIPTION DRUG Achromycin V Tetracycline HCl CAPSULE ORAL 20131018 NDA NDA050278 Heritage Pharmaceuticals Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 23155-488_d877f7f0-ed9d-48b0-8ea0-11e672d27307 23155-488 HUMAN PRESCRIPTION DRUG Achromycin V Tetracycline HCl CAPSULE ORAL 20131018 NDA NDA050278 Heritage Pharmaceuticals Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 23155-489_311dd740-6596-4128-a37e-d97040bf22fa 23155-489 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20170526 ANDA ANDA207880 Heritage Pharmaceuticals Inc. DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 23155-490_311dd740-6596-4128-a37e-d97040bf22fa 23155-490 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20170526 ANDA ANDA207880 Heritage Pharmaceuticals Inc. DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 23155-497_328bcba6-a2f8-4216-8f6f-c40959fe8779 23155-497 HUMAN PRESCRIPTION DRUG Prochlorperazine Edisylate Prochlorperazine Edisylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20150114 ANDA ANDA204147 Heritage Pharmaceuticals Inc. PROCHLORPERAZINE EDISYLATE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 23155-500_7e141a79-fb9e-41a3-8591-9f537b0b3373 23155-500 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 Heritage Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 23155-501_7e141a79-fb9e-41a3-8591-9f537b0b3373 23155-501 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 Heritage Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 23155-502_7e141a79-fb9e-41a3-8591-9f537b0b3373 23155-502 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 Heritage Pharmaceuticals Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 23155-512_8ae34f95-b90f-46cc-8da5-cc4d8088b6f6 23155-512 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE, LIQUID FILLED ORAL 20171107 ANDA ANDA077811 Heritage Pharmaceuticals Inc. NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 23155-519_4773f833-4d9d-4e7e-80be-2bb01c7a4d46 23155-519 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20170105 ANDA ANDA075522 Heritage Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 23155-521_3b918f05-7bc3-4727-bcd0-d6c718b6efe7 23155-521 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAVENOUS 20150626 ANDA ANDA203428 Heritage Pharmaceuticals Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 23155-522_151cc356-7566-4258-b675-a8219ddb5f29 23155-522 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION INTRAVENOUS 20120913 ANDA ANDA204618 Heritage Pharmaceuticals Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] E 20171231 23155-523_0c5c78bc-d914-40ae-9ca2-cf1c99a94e89 23155-523 HUMAN PRESCRIPTION DRUG Prochlorperazine Edisylate Prochlorperazine Edisylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20150626 ANDA ANDA204147 Heritage Pharmaceuticals Inc. PROCHLORPERAZINE EDISYLATE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 23155-524_bc2b6592-0dbc-46c3-87ec-b3a82c2199f6 23155-524 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20140813 ANDA ANDA203521 Heritage Pharmaceuticals Inc. TRANEXAMIC ACID 1 g/10mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] E 20171231 23155-525_d883e282-bd09-415e-bb0b-caeadca5be2a 23155-525 HUMAN PRESCRIPTION DRUG Zoledronic acid Zoledronic acid INJECTION, SOLUTION INTRAVENOUS 20121220 ANDA ANDA201801 Heritage Pharmaceuticals Inc. ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 23155-528_93e05aa6-1918-41ff-bcda-fb49172a8a0d 23155-528 HUMAN PRESCRIPTION DRUG Gemcitabine hydrochloride Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20121022 ANDA ANDA202063 Heritage Pharmaceuticals Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 23155-529_93e05aa6-1918-41ff-bcda-fb49172a8a0d 23155-529 HUMAN PRESCRIPTION DRUG Gemcitabine hydrochloride Gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20121022 ANDA ANDA202063 Heritage Pharmaceuticals Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 23155-530_ddb698e2-6dc3-40c2-b687-fa640fdb2d2d 23155-530 HUMAN PRESCRIPTION DRUG Trospium Chloride Trospium Chloride TABLET, FILM COATED ORAL 20151116 ANDA ANDA204945 Heritage Pharmaceuticals Inc. TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 23155-531_061791e5-40d3-4589-97cb-9ec05f4d1806 23155-531 HUMAN PRESCRIPTION DRUG CALCIUM ACETATE calcium acetate CAPSULE ORAL 20150707 ANDA ANDA202315 Heritage Pharmaceuticals Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 23155-532_82372638-ecaa-40aa-8357-c72e57547765 23155-532 HUMAN PRESCRIPTION DRUG ETHOSUXIMIDE ETHOSUXIMIDE CAPSULE ORAL 20121010 ANDA ANDA200892 Heritage Pharmaceuticals Inc. ETHOSUXIMIDE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 23155-547_bd9300da-979a-4a06-aace-1abc6b64f12c 23155-547 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON INJECTION INTRAMUSCULAR; INTRAVENOUS 20120615 ANDA ANDA079224 Heritage Pharmaceuticals ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 23155-549_bd9300da-979a-4a06-aace-1abc6b64f12c 23155-549 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON INJECTION INTRAMUSCULAR; INTRAVENOUS 20120615 ANDA ANDA090648 Heritage Pharmaceuticals ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 23155-568_510aa8e6-934e-4895-a047-0573dfa4ec31 23155-568 HUMAN PRESCRIPTION DRUG Metronidazole 250 mg Metronidazole TABLET, FILM COATED ORAL 20160613 ANDA ANDA070040 Heritage Pharmaceuticals Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 23155-569_56644608-a56e-4bad-b2a6-8878be6de8b1 23155-569 HUMAN PRESCRIPTION DRUG Metronidazole 500 mg Metronidazole TABLET, FILM COATED ORAL 20160613 ANDA ANDA070039 Heritage Pharmaceuticals Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 23155-578_23133083-8d17-42dc-850c-290b140f9410 23155-578 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20161101 ANDA ANDA207433 Heritage Pharmaceuticals Inc. DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 23155-579_23133083-8d17-42dc-850c-290b140f9410 23155-579 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20161101 ANDA ANDA207433 Heritage Pharmaceuticals Inc. DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 23155-580_23133083-8d17-42dc-850c-290b140f9410 23155-580 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20161101 ANDA ANDA207433 Heritage Pharmaceuticals Inc. DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 23155-581_23133083-8d17-42dc-850c-290b140f9410 23155-581 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20161101 ANDA ANDA207433 Heritage Pharmaceuticals Inc. DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 23155-582_23133083-8d17-42dc-850c-290b140f9410 23155-582 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20161101 ANDA ANDA207433 Heritage Pharmaceuticals Inc. DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 23155-583_23133083-8d17-42dc-850c-290b140f9410 23155-583 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20161101 ANDA ANDA207433 Heritage Pharmaceuticals Inc. DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 23155-600_09734c3d-5397-4d44-bef1-c26b3aade246 23155-600 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161108 ANDA ANDA090696 Heritage Pharmaceuticals MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 23155-601_c199e9e7-6b0c-4bb9-8813-1425dad7d89e 23155-601 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161107 ANDA ANDA090850 Heritage Pharmaceuticals MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 23155-604_c4722be0-1f6d-49c9-b171-8800eff9ff82 23155-604 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20171101 ANDA ANDA207196 HERITAGE PHARMACEUTICALS INC. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 23155-605_c4722be0-1f6d-49c9-b171-8800eff9ff82 23155-605 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20171101 ANDA ANDA207196 HERITAGE PHARMACEUTICALS INC. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 23155-606_26cdd84d-ffa0-4e52-b359-4acef4bd8093 23155-606 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20170227 ANDA ANDA207201 Heritage Pharmaceuticals Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 23155-607_26cdd84d-ffa0-4e52-b359-4acef4bd8093 23155-607 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20170227 ANDA ANDA207201 Heritage Pharmaceuticals Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 23155-621_2d414373-082e-4a73-a6e4-4fc5f1dd5347 23155-621 HUMAN PRESCRIPTION DRUG CALCIUM ACETATE CALCIUM ACETATE TABLET ORAL 20120223 ANDA ANDA202885 Heritage Pharmaceuticals Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 23155-644_69092b0c-ce00-40b1-b56c-85a27d4c7430 23155-644 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM 25 mg LOSARTAN POTASSIUM TABLET, FILM COATED ORAL 20180104 ANDA ANDA090382 Heritage Pharmaceuticals Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 23155-645_69092b0c-ce00-40b1-b56c-85a27d4c7430 23155-645 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM 50 mg LOSARTAN POTASSIUM TABLET, FILM COATED ORAL 20180104 ANDA ANDA090382 Heritage Pharmaceuticals Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 23155-646_69092b0c-ce00-40b1-b56c-85a27d4c7430 23155-646 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM 100 mg LOSARTAN POTASSIUM TABLET, FILM COATED ORAL 20180104 ANDA ANDA090382 Heritage Pharmaceuticals Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 23155-651_8684670e-63d3-4de8-937b-bc25f51724a9 23155-651 HUMAN PRESCRIPTION DRUG Metronidazole METRONIDAZOLE TABLET ORAL 20150923 ANDA ANDA205245 Heritage Pharmaceuticals Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 23155-652_8684670e-63d3-4de8-937b-bc25f51724a9 23155-652 HUMAN PRESCRIPTION DRUG Metronidazole METRONIDAZOLE TABLET ORAL 20150923 ANDA ANDA205245 Heritage Pharmaceuticals Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 23264-100_44d0bc8a-ec26-43e7-e054-00144ff8d46c 23264-100 HUMAN OTC DRUG Aunt Ks Oatmeal, Collodial POWDER TOPICAL 20141110 OTC MONOGRAPH FINAL part347 Comfy Bottoms, LLC OATMEAL 1.25 g/100g E 20171231 23264-200_44d0bc8a-ec26-43e7-e054-00144ff8d46c 23264-200 HUMAN OTC DRUG Aunt Ks Oatmeal, Colloidal POWDER TOPICAL 20141114 OTC MONOGRAPH FINAL part347 Comfy Bottoms, LLC OATMEAL 1.25 g/100g E 20171231 23264-300_44d0bc8a-ec26-43e7-e054-00144ff8d46c 23264-300 HUMAN OTC DRUG Aunt Ks Oatmeal Colloidal POWDER TOPICAL 20141114 OTC MONOGRAPH FINAL part347 Comfy Bottoms, LLC OATMEAL 1.25 g/100g E 20171231 23359-023_03a0c43b-b783-44a6-a9ff-ad862fb95a82 23359-023 HUMAN OTC DRUG Rydex Brompheniramine Maleate, Codeine Phosphate, Pseudoephedrine Hydrochloride LIQUID ORAL 20100514 OTC MONOGRAPH FINAL part341 Centurion Labs BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1.33; 6.33; 10 mg/5mL; mg/5mL; mg/5mL CV E 20171231 23359-032_47acedfb-4259-40c0-9c81-a68743f298c0 23359-032 HUMAN OTC DRUG Ninjacof chlophedianol hcl and pyrilamine maleate SOLUTION ORAL 20141015 OTC MONOGRAPH FINAL part341 Centurion Labs, LLC CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE 12.5; 12.5 mg/5mL; mg/5mL N 20181231 23359-033_3804bfa6-1470-402f-9577-3f6f2616ff1e 23359-033 HUMAN OTC DRUG Ninjacof-A Ninjacof-A LIQUID ORAL 20141015 OTC MONOGRAPH FINAL part341 Centurion Labs, LLC ACETAMINOPHEN; CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE 160; 12.5; 12.5 mg/5mL; mg/5mL; mg/5mL E 20171231 23359-034_d29c81fd-72cd-4f11-846e-3bead1de5608 23359-034 HUMAN OTC DRUG Ninjacof-D Chlophedianol Hydrochloride, Pyrilamine Maleate, Pseudoephedrine Hydrochloride LIQUID ORAL 20170816 OTC MONOGRAPH FINAL part341 Centurion Labs, LLC CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 12.5; 12.5; 30 mg/5mL; mg/5mL; mg/5mL N 20181231 23359-040_47ba8466-68bc-4b31-89c9-6340dff26e9a 23359-040 HUMAN OTC DRUG Ninjacof-XG Codeine Phosphate LIQUID ORAL 20141120 OTC MONOGRAPH FINAL part341 Centurion Labs, LLC CODEINE PHOSPHATE; GUAIFENESIN 8; 200 mg/5mL; mg/5mL E 20171231 23359-100_00a6e59a-4714-46ab-8119-12db89deff27 23359-100 HUMAN PRESCRIPTION DRUG Centratex Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, a CAPSULE ORAL 20090614 UNAPPROVED DRUG OTHER Centurion Labs IRON; SODIUM ASCORBATE; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; NIACINAMIDE; CALCIUM PANTOTHENATE; ZINC SULFATE; MAGNESIUM SULFATE; MANGANESE SULFATE; CUPRIC SULFATE ANHYDROUS 106; 200; 10; 6; 5; 1; 15; 30; 10; 18.2; 6.9; 1.3; .8 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 23359-105_8c1b2367-cec5-4a18-82a0-e132b4aece3a 23359-105 HUMAN PRESCRIPTION DRUG C-Nate DHA omega-3 fatty acids, icosapent, doconexent, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, .alpha.-tocopherol, d-, cupric sulfate, zinc oxide, ferrous fumarate and magnesium oxide CAPSULE, GELATIN COATED ORAL 20130101 UNAPPROVED DRUG OTHER Centurion Labs, LLC OMEGA-3 FATTY ACIDS; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; CHOLECALCIFEROL; ASCORBIC ACID; .ALPHA.-TOCOPHEROL, D-; CUPRIC SULFATE; ZINC OXIDE; FERROUS FUMARATE; MAGNESIUM 200; 3; 3; 20; 15; 1; 400; 100; 30; 1; 20; 28; 30 mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] E 20171231 23360-160_dd793afb-bc0c-4f56-a925-238e139155c3 23360-160 HUMAN PRESCRIPTION DRUG Vecuronium bromide Vecuronium bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100915 ANDA ANDA090243 Akorn - Strides LLC VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] E 20171231 23390-1020_90c33e01-d809-4ce2-9d16-ab3ac535ebe4 23390-1020 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060505 UNAPPROVED MEDICAL GAS Denman Services, Inc. OXYGEN 99 L/100L E 20171231 23558-0569_094fe364-ed6c-426e-af21-f6df02323d4d 23558-0569 HUMAN OTC DRUG Saline Nasal Sodium Chloride 0.65% SPRAY NASAL 20130701 OTC MONOGRAPH FINAL part349 Lee Pharmaceuticals SODIUM CHLORIDE 6.5 mg/mL E 20171231 23558-5120_988b789b-822f-462a-9ea3-20035d78107e 23558-5120 HUMAN OTC DRUG Sound Body 12 Hour Nasal Original Oxymetazoline Hydrochloride SPRAY NASAL 20080131 OTC MONOGRAPH FINAL part341 Lee Pharmaceuticals OXYMETAZOLINE HYDROCHLORIDE 50 mg/100mL E 20171231 23558-5504_b8f7b5eb-0477-4117-a170-cba92901808a 23558-5504 HUMAN OTC DRUG Cheracol D Cough Formula 4oz Maximum Strength Cough Relief SYRUP ORAL 20111201 OTC MONOGRAPH FINAL part341 Lee Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 23558-6881_7bce1be7-d7a9-44e9-8e84-2c3386c61da0 23558-6881 HUMAN OTC DRUG Saline Nasal 2oz Sodium chloride 0.65% SPRAY NASAL 20131001 OTC MONOGRAPH FINAL part349 Lee Pharmaceuticals SODIUM CHLORIDE 6.5 mg/mL E 20171231 23558-6895_b7d106d2-d409-40f3-a138-8dd341c24bb6 23558-6895 HUMAN OTC DRUG Saline Nasal 3oz Sodium chloride 0.65% SPRAY NASAL 20131001 OTC MONOGRAPH FINAL part349 Lee Pharmaceuticals SODIUM CHLORIDE 6.5 mg/mL E 20171231 23558-6896_bf6a1e44-7365-4717-94aa-25c933408314 23558-6896 HUMAN OTC DRUG Saline Nasal 1.5oz Sodium chloride 0.65% SPRAY NASAL 20131001 OTC MONOGRAPH FINAL part349 Lee Pharmaceuticals SODIUM CHLORIDE 6.5 mg/mL E 20171231 23594-505_38a6556f-16e1-4ed2-b165-545c58d48be2 23594-505 HUMAN PRESCRIPTION DRUG MILLIPRED PREDNISOLONE TABLET ORAL 20140301 ANDA ANDA080354 Zylera Pharmaceuticals, LLC PREDNISOLONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 23594-510_34442114-4a5c-49dd-9198-3d6be5d55f86 23594-510 HUMAN PRESCRIPTION DRUG Millipred PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20140301 ANDA ANDA078465 Zylera Pharmaceuticals, LLC PREDNISOLONE SODIUM PHOSPHATE 10 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 23594-780_8990b8df-95c3-47a6-ab26-cc7224f2cd1e 23594-780 HUMAN PRESCRIPTION DRUG Ulesfia benzyl alcohol LOTION TOPICAL 20140716 NDA NDA022129 Zylera Pharmaceuticals, LLC BENZYL ALCOHOL 50 mg/g Pediculicide [EPC] N 20181231 23594-915_d8f9ca9f-623f-418b-9436-d87570143dfb 23594-915 HUMAN PRESCRIPTION DRUG Veripred 20 PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20140801 ANDA ANDA078988 Zylera Pharmaceuticals, LLC PREDNISOLONE SODIUM PHOSPHATE 20 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 23635-115_66940157-741a-4ef9-aac2-1948da9f7e2b 23635-115 HUMAN PRESCRIPTION DRUG Xartemis XR oxycodone hydrochloride and acetaminophen TABLET, COATED ORAL 20130430 20190531 NDA NDA204031 Mallinckrodt, Inc OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 23635-408_2a51603e-e295-4910-9890-401986f66d29 23635-408 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 Mallinckrodt, Inc HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 23635-412_2a51603e-e295-4910-9890-401986f66d29 23635-412 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 Mallinckrodt, Inc HYDROMORPHONE HYDROCHLORIDE 12 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 23635-416_2a51603e-e295-4910-9890-401986f66d29 23635-416 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 Mallinckrodt, Inc HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 23635-432_2a51603e-e295-4910-9890-401986f66d29 23635-432 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120824 NDA NDA021217 Mallinckrodt, Inc HYDROMORPHONE HYDROCHLORIDE 32 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 23635-580_40f3d68c-7ee0-4ee2-a51f-99ac4ccd35a1 23635-580 HUMAN PRESCRIPTION DRUG Roxicodone oxycodone hydrochloride TABLET ORAL 20090826 NDA NDA021011 SpecGx LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 23635-581_40f3d68c-7ee0-4ee2-a51f-99ac4ccd35a1 23635-581 HUMAN PRESCRIPTION DRUG Roxicodone oxycodone hydrochloride TABLET ORAL 20000831 NDA NDA021011 SpecGx LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 23635-582_40f3d68c-7ee0-4ee2-a51f-99ac4ccd35a1 23635-582 HUMAN PRESCRIPTION DRUG Roxicodone oxycodone hydrochloride TABLET ORAL 20000831 NDA NDA021011 SpecGx LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 23636-1001_c9d5436a-b2fe-4e0f-aaa9-4a584fbd59e9 23636-1001 HUMAN OTC DRUG NBF Gingival SODIUM MONOFLUOROPHOSPHATE GEL DENTAL 20111111 UNAPPROVED DRUG OTHER NanoCureTech SODIUM MONOFLUOROPHOSPHATE .4 g/30g E 20171231 23636-1002_726b7f4d-2a83-4312-89cd-3d955e9b8cdd 23636-1002 HUMAN OTC DRUG New NBF GINGIVAL Gel Glycerin, Menthol GEL DENTAL 20171127 OTC MONOGRAPH NOT FINAL part356 NanoCureTech GLYCERIN; LEVOMENTHOL 9.01; .4 g/100g; g/100g N 20181231 23637-001_ddc612b6-7001-48ed-a724-1e12f932c618 23637-001 HUMAN OTC DRUG Bioxsine Series Pyrithione Zinc SHAMPOO TOPICAL 20120101 OTC MONOGRAPH FINAL part358H B'IOTA Laboratories PYRITHIONE ZINC 4.5 mL/300mL N 20181231 23637-002_75a43019-36aa-4245-bc67-854965b5eada 23637-002 HUMAN OTC DRUG Advanced Herbal Care for thinning-damaged hair Pyrithione Zinc SHAMPOO TOPICAL 20180116 OTC MONOGRAPH FINAL part358H B'IOTA Laboratories PYRITHIONE ZINC .15 g/mL N 20191231 23638-1111_78140cd2-3fad-44a9-b6bc-3cccb1ca6a9e 23638-1111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20111121 OTC MONOGRAPH NOT FINAL part333E Sanear Corporation ALCOHOL 665 mL/L N 20181231 23644-001_1e5414d1-4106-4397-9ad0-53867fd8f9d3 23644-001 HUMAN PRESCRIPTION DRUG Oxygen, Compressed OXYGEN GAS RESPIRATORY (INHALATION) 20111215 UNAPPROVED MEDICAL GAS Home Care Pharmacy of Palm Coast, Inc. OXYGEN 1 L/L E 20171231 23647-001_bc594301-f20a-4074-bddb-74cfef50f17d 23647-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20111030 NDA NDA205712 SYOXSA, Inc. OXYGEN 995 mL/L N 20181231 23647-002_60befc68-d23c-2bdf-e053-2991aa0ab655 23647-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20111030 NDA NDA205829 SYOXSA, Inc. NITROGEN 990 mL/L N 20181231 23650-001_60ad46f1-bf8f-8de4-e053-2a91aa0a277a 23650-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060101 NDA NDA205767 New Bedford Welding Supply, Inc. OXYGEN 990 mL/L N 20181231 23667-002_9db56e9b-efc0-4fb2-8ab6-a5b5ee1ade28 23667-002 HUMAN OTC DRUG Hawaiian Tropic Tanning AVOBENZONE,OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Formulated Solutions AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 2; 1.5 mL/100mL; mL/100mL; mL/100mL N 20181231 23667-800_5fda29d1-591d-0b4a-e053-2991aa0a4419 23667-800 HUMAN OTC DRUG Coppertone Clearly Sheer Whipped Sunscreen Broad Spectrum SPF 50 SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20170209 OTC MONOGRAPH NOT FINAL part352 Formulated Solutions, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 45; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 23667-801_5fda0425-94c0-7d05-e053-2a91aa0a7b1a 23667-801 HUMAN OTC DRUG Coppertone Clearly Sheer Whipped Sunscreen Broad Spectrum SPF 30 SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170209 OTC MONOGRAPH NOT FINAL part352 Formulated Solutions, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 45; 80 mg/g; mg/g; mg/g; mg/g N 20181231 23667-802_5fda2d9d-28a6-74a2-e053-2991aa0ae58f 23667-802 HUMAN OTC DRUG Copperstone Water Babies Pure and Simple Whipped Sunscreen Broad Spectrum SPF 50 SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20170209 OTC MONOGRAPH NOT FINAL part352 Formulated Solutions, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 45; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 23667-803_46c5fa20-1283-272e-e054-00144ff8d46c 23667-803 HUMAN OTC DRUG GoodSense Athletes Foot Antifungal TOLNAFTATE SPRAY TOPICAL 20170120 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23667-804_46c5fa20-1286-272e-e054-00144ff8d46c 23667-804 HUMAN OTC DRUG Good Neighbor Pharmacy Athletes foot Relief Antifungal MICONAZOLE NITRATE SPRAY TOPICAL 20170120 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC MICONAZOLE NITRATE 20 mg/g N 20181231 23667-805_5fda2d9d-28b5-74a2-e053-2991aa0ae58f 23667-805 HUMAN OTC DRUG CVS Health Antifungal Anthletes Foot TOLNAFTATE SPRAY TOPICAL 20170209 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23667-806_46c63728-fa38-2132-e054-00144ff8d46c 23667-806 HUMAN OTC DRUG GoodSense Powder Jock Itch Antifungal TOLNAFTATE SPRAY TOPICAL 20170120 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23667-807_46c5fa20-12a9-272e-e054-00144ff8d46c 23667-807 HUMAN OTC DRUG Walgreens Maximum Strength Jock Itch Antifungal TOLNAFTATE SPRAY TOPICAL 20170120 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23667-808_46c63c9a-d44f-382e-e054-00144ff8d46c 23667-808 HUMAN OTC DRUG Meijer Jock Itch Relief Antifungal MICONAZOLE NITRATE SPRAY TOPICAL 20170120 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC MICONAZOLE NITRATE 20 mg/g N 20181231 23667-809_46c5b9a6-99eb-7343-e054-00144ff88e88 23667-809 HUMAN OTC DRUG Meijer Maximum Strength Jock Itch Relief Antifungal TOLNAFTATE SPRAY TOPICAL 20170121 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23667-810_46c5b9a6-99fd-7343-e054-00144ff88e88 23667-810 HUMAN OTC DRUG Meijer Maximum Strength Anthletes foot Antifungal TOLNAFTATE SPRAY TOPICAL 20170120 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23667-811_46c6362f-2658-36b8-e054-00144ff8d46c 23667-811 HUMAN OTC DRUG Meijer Maximum Strength Athletes Foot Antifungal TOLNAFTATE LIQUID TOPICAL 20170121 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23667-812_46c5fa20-12ab-272e-e054-00144ff8d46c 23667-812 HUMAN OTC DRUG Signature Care Athletes Foot MICONAZOLE NITRATE SPRAY TOPICAL 20170120 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC MICONAZOLE NITRATE 20 mg/g N 20181231 23667-813_46c6362f-265a-36b8-e054-00144ff8d46c 23667-813 HUMAN OTC DRUG Signature Care Athletes Foot Antifungal TOLNAFTATE LIQUID TOPICAL 20170121 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23667-814_46c643a7-c50e-17d4-e054-00144ff88e88 23667-814 HUMAN OTC DRUG Signature Athletes Foot Antifungal TOLNAFTATE POWDER TOPICAL 20170121 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23667-815_46c63c9a-d460-382e-e054-00144ff8d46c 23667-815 HUMAN OTC DRUG SmartSense Maximum Strength Athletes Foot Relief antifungal TOLNAFTATE SPRAY TOPICAL 20170123 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23667-816_46c63728-fa49-2132-e054-00144ff8d46c 23667-816 HUMAN OTC DRUG Up and Up Soothing Antifungal TOLNAFTATE LIQUID TOPICAL 20170123 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23667-817_46c63c9a-d483-382e-e054-00144ff8d46c 23667-817 HUMAN OTC DRUG Walgreens Medicated Antifungal Athletes Foot MICONAZOLE NITRATE SPRAY TOPICAL 20170123 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC MICONAZOLE NITRATE 20 mg/g N 20181231 23667-818_46c63c9a-d485-382e-e054-00144ff8d46c 23667-818 HUMAN OTC DRUG Walgreens Medicated Antifungal Athletes Foot TOLNAFTATE SPRAY TOPICAL 20170123 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23667-819_5fd9e846-89dc-5477-e053-2a91aa0a67ad 23667-819 HUMAN OTC DRUG Good Neighbor Pharmacy Jock Itch Relief Antifungal MICONAZOLE NITRATE SPRAY TOPICAL 20170209 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC MICONAZOLE NITRATE 20 mg/g N 20181231 23667-820_46c63c9a-d499-382e-e054-00144ff8d46c 23667-820 HUMAN OTC DRUG Good Neighbor Pharmacy Maximum Strength Athletes Foot Relief Antifungal TOLNAFTATE SPRAY TOPICAL 20170120 OTC MONOGRAPH FINAL part333C Formulated Solutions, LLC TOLNAFTATE 10 mg/g N 20181231 23710-006_86123a02-9645-4ce1-819b-303e6f8bb6bc 23710-006 HUMAN PRESCRIPTION DRUG Salvax salicylic acid AEROSOL, FOAM TOPICAL 20090101 UNAPPROVED DRUG OTHER Exeltis USA Dermatology, LLC SALICYLIC ACID 3.88 g/70g N 20181231 23710-035_a2ebc605-02a0-4ce1-b4c1-0d752094ad07 23710-035 HUMAN PRESCRIPTION DRUG Hydro 35 Urea in a water and lipid based foam containing lactic acid AEROSOL, FOAM TOPICAL 20090620 UNAPPROVED DRUG OTHER Exeltis USA Dermatology, LLC UREA 35 g/100g N 20181231 23710-052_49f6982f-3855-4aee-bdac-47cf463a7908 23710-052 NON-STANDARDIZED ALLERGENIC Clease and Treat benzoyl peroxide pad and salicylic acid pad CLOTH TOPICAL 20090101 UNAPPROVED DRUG OTHER Quinnova Pharmaceuticals, Inc. BENZOYL PEROXIDE; SELENIUM SULFIDE .8; .5 g/5g; g/5g E 20171231 23710-100_1fa781f0-61fc-4458-b6d2-f363904a67b3 23710-100 HUMAN PRESCRIPTION DRUG ECOZA econazole nitrate AEROSOL, FOAM TOPICAL 20131025 NDA NDA205175 Exeltis USA Dermatology, LLC ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 23710-225_9d2f4f41-7b68-4a0c-addf-7823496e68df 23710-225 NON-STANDARDIZED ALLERGENIC TERSI selenium sulfide AEROSOL, FOAM TOPICAL 20091201 UNAPPROVED DRUG OTHER Quinnova Pharmaceuticals, Inc. SELENIUM SULFIDE 1.44 g/70g E 20171231 23710-900_b9799388-885f-443a-baa5-2adce32f2583 23710-900 HUMAN PRESCRIPTION DRUG REPREXAIN Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20100218 ANDA ANDA076642 Quinnova Pharmaceuticals, LLC HYDROCODONE BITARTRATE; IBUPROFEN 2.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII N 20181231 23710-901_b9799388-885f-443a-baa5-2adce32f2583 23710-901 HUMAN PRESCRIPTION DRUG REPREXAIN Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20100218 ANDA ANDA076642 Quinnova Pharmaceuticals, LLC HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII N 20181231 23710-902_b9799388-885f-443a-baa5-2adce32f2583 23710-902 HUMAN PRESCRIPTION DRUG REPREXAIN Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20100218 ANDA ANDA076642 Quinnova Pharmaceuticals, LLC HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII N 20181231 23731-6030_bec85982-49c5-47ef-b16e-73f61ce4bf81 23731-6030 HUMAN PRESCRIPTION DRUG triCitrasol Trisodium Citrate dihydrate SOLUTION EXTRACORPOREAL 20030710 NDA BN010409 Citra Labs LLC TRISODIUM CITRATE DIHYDRATE .467 g/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 23731-6051_eefbb715-8564-46ed-b82c-b186e2d1d6f5 23731-6051 HUMAN PRESCRIPTION DRUG Anticoagulant Citrate Dextrose A Anhydrous Citric Acid, Dextrose Monohydrate, and Trisodium Citrate Dihydrate SOLUTION EXTRACORPOREAL 20030826 NDA BN020037 Citra Labs DEXTROSE MONOHYDRATE; ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE 24.5; 7.3; 22 mg/mL; mg/mL; mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 23731-7000_39fa60ec-a741-4582-8159-7a4075a7e0ff 23731-7000 HUMAN PRESCRIPTION DRUG Rejuvesol Sodium Pyruvate, Inosine, Adenine, Sodium Phosphate, Dibasic, and Sodium Phosphate, Monobasic, Monohydrate SOLUTION EXTRACORPOREAL 19970226 NDA BN950522 Citra Labs LLC SODIUM PYRUVATE; INOSINE; ADENINE; SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .55; 1.34; .034; .73; .311 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL E 20171231 23916-1234_a84e1e06-1e66-456e-b0db-e492d3fbcde5 23916-1234 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060525 UNAPPROVED MEDICAL GAS Cedar Mountain Respiratory, Inc. OXYGEN 99 L/100L E 20171231 24027-0699_54c2d68b-62d5-40e1-9e7f-a405057b400c 24027-0699 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20001023 UNAPPROVED MEDICAL GAS Broadway Medical Service & Supply, Inc. OXYGEN 99 L/100L E 20171231 24090-410_91415c8b-4318-4716-8c32-05dbb7fcb218 24090-410 HUMAN PRESCRIPTION DRUG NitroMist nitroglycerin AEROSOL, METERED SUBLINGUAL 20100501 20180531 NDA NDA021780 Akrimax Pharmaceuticals, LLC NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 24090-450_8a9095b7-48a2-4920-9b5e-08a05c21d089 24090-450 HUMAN PRESCRIPTION DRUG InnoPran XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130601 20190831 NDA NDA021438 Akrimax Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24090-451_8a9095b7-48a2-4920-9b5e-08a05c21d089 24090-451 HUMAN PRESCRIPTION DRUG InnoPran XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130601 20190831 NDA NDA021438 Akrimax Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24090-490_4fa21864-a3e9-4db6-a4d5-0dd06760e493 24090-490 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA022121 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 13 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 24090-491_4fa21864-a3e9-4db6-a4d5-0dd06760e493 24090-491 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 24090-492_4fa21864-a3e9-4db6-a4d5-0dd06760e493 24090-492 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 24090-493_4fa21864-a3e9-4db6-a4d5-0dd06760e493 24090-493 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 24090-494_4fa21864-a3e9-4db6-a4d5-0dd06760e493 24090-494 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 24090-495_4fa21864-a3e9-4db6-a4d5-0dd06760e493 24090-495 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 24090-496_4fa21864-a3e9-4db6-a4d5-0dd06760e493 24090-496 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 24090-497_4fa21864-a3e9-4db6-a4d5-0dd06760e493 24090-497 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 24090-498_4fa21864-a3e9-4db6-a4d5-0dd06760e493 24090-498 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 24090-499_4fa21864-a3e9-4db6-a4d5-0dd06760e493 24090-499 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 24090-500_4fa21864-a3e9-4db6-a4d5-0dd06760e493 24090-500 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 24090-501_4fa21864-a3e9-4db6-a4d5-0dd06760e493 24090-501 HUMAN PRESCRIPTION DRUG Tirosint Levothyroxine Sodium CAPSULE ORAL 20100401 NDA NDA021924 Akrimax Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 24090-681_5e7f7654-9d66-6b46-e053-2991aa0a2007 24090-681 HUMAN PRESCRIPTION DRUG Primlev oxycodone and acetaminophen TABLET ORAL 20111201 ANDA ANDA040608 Akrimax Pharmaceuticals, LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 24090-682_5e7f7654-9d66-6b46-e053-2991aa0a2007 24090-682 HUMAN PRESCRIPTION DRUG Primlev oxycodone and acetaminophen TABLET ORAL 20111201 ANDA ANDA040608 Akrimax Pharmaceuticals, LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 24090-683_5e7f7654-9d66-6b46-e053-2991aa0a2007 24090-683 HUMAN PRESCRIPTION DRUG Primlev oxycodone and acetaminophen TABLET ORAL 20111201 ANDA ANDA040608 Akrimax Pharmaceuticals, LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 24090-720_07c9de34-2f13-4468-aae9-35cf1098ee74 24090-720 HUMAN PRESCRIPTION DRUG Suprenza phentermine hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20121214 20180930 NDA NDA202088 Akrimax Pharmaceuticals, LLC PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 24090-721_07c9de34-2f13-4468-aae9-35cf1098ee74 24090-721 HUMAN PRESCRIPTION DRUG Suprenza phentermine hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20121214 20180930 NDA NDA202088 Akrimax Pharmaceuticals, LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 24090-722_07c9de34-2f13-4468-aae9-35cf1098ee74 24090-722 HUMAN PRESCRIPTION DRUG Suprenza phentermine hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20121214 20180930 NDA NDA202088 Akrimax Pharmaceuticals, LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 24165-0001_195a2d37-39eb-98c1-8bd3-2759cd2d69d9 24165-0001 HUMAN OTC DRUG Renew Sanicula, Abrotanum, Argentum nitricum, Arsenicum album, Baryta carbonica, Borax, Bryonia, Cactus grandiflorus, Calcarea fluorica, Calcarea phosphorica, Calcarea sulphurica, Chelidonium majus, Cholesterinum, Coffea cruda, Conium maculatum, Dulcamara, Ferrum phosphoricum, Fumaria officinalis, Gratiola officinalis, Helleborus niger, Hepar sulphuris calcareum, Hydrastis canadensis, Hydrofluoricum acidum, Iodium, Kali carbonicum, Kali muriaticum, Kali phosphoricum, Kali sulphuricum, Lilium tigrinum LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Anila, Inc. CALCIUM CHLORIDE; CALCIUM BICARBONATE; POTASSIUM SULFATE; SODIUM BICARBONATE; ARTEMISIA ABROTANUM FLOWERING TOP; SILVER NITRATE; ARSENIC TRIOXIDE; BARIUM CARBONATE; SODIUM BORATE; BRYONIA ALBA ROOT; SELENICEREUS GRANDIFLORUS STEM; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; CHELIDONIUM MAJUS; CHOLESTEROL; ARABICA COFFEE BEAN; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; HYDROFLUORIC ACID; FUMARIA OFFICINALIS FLOWERING TOP; GRATIOLA OFFICINALIS; HELLEBORUS NIGER ROOT; CALCIUM SULFIDE; GOLDENSEAL; IODINE; POTASSIUM CARBONATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; SMILAX REGELII ROOT; CLAVICEPS PURPUREA SCLEROTIUM; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SPIGELIA ANTHELMIA; SULFUR 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 24201-237_bbcd9c21-23b4-4df2-8ce5-eced5d5f366a 24201-237 HUMAN PRESCRIPTION DRUG fludarabine phosphate fludarabine phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141215 ANDA ANDA076349 Leucadia Pharmaceuticals FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 24202-001_38db9a9a-8d68-4f7d-8ef8-9d128a8a394e 24202-001 HUMAN OTC DRUG CALCID ANTACID CALCIUM SUPPLEMENT REGULAR STRENGTH Calcium carbonate TABLET, CHEWABLE ORAL 20111230 OTC MONOGRAPH FINAL part331 Pro-ventas S.A. de C.V. CALCIUM CARBONATE 500 mg/1 E 20171231 24202-002_bd78021d-079f-4bfb-bfce-efff02835f00 24202-002 HUMAN OTC DRUG CALCID ANTACID CALCIUM SUPPLEMENT REGULAR STRENGTH Calcium carbonate TABLET, CHEWABLE ORAL 20111230 OTC MONOGRAPH FINAL part331 Pro-ventas S.A. de C.V. CALCIUM CARBONATE 500 mg/1 E 20171231 24205-080_4e924fa8-cfb0-416d-8330-215a0221d673 24205-080 HUMAN OTC DRUG COMPANIONS Luxury Foam Hand So ap, Antimicrobial Chloroxylenol LIQUID TOPICAL 20051115 OTC MONOGRAPH NOT FINAL part333E UniPro Foodservice, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 24205-400_ad3a227d-b8ec-437b-9132-78b7681a8042 24205-400 HUMAN OTC DRUG COMPANIONS Antibacterial Plum Foam So ap Benzalkonium Chloride LIQUID TOPICAL 20170415 OTC MONOGRAPH NOT FINAL part333E UniPro Foodservice, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 24208-002_cfc2fb7f-feb8-4f8b-ba83-9b666e5cf11d 24208-002 HUMAN PRESCRIPTION DRUG VITRASE hyaluronidase, ovine INJECTION, SOLUTION SUBCUTANEOUS 20050201 NDA NDA021640 Bausch & Lomb Incorporated HYALURONIDASE, OVINE 200 [USP'U]/mL Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] N 20181231 24208-004_9a048c08-a589-43c8-a2a2-89180440d2ea 24208-004 HUMAN PRESCRIPTION DRUG Istalol Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20040802 NDA NDA021516 Bausch & Lomb Incorporated TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24208-070_fb2fec84-9ad6-48aa-930f-8bd5078bb2d9 24208-070 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated WATER 99.05 mL/100mL N 20181231 24208-073_c976819c-1664-447e-8128-d5eb2822e7f0 24208-073 HUMAN OTC DRUG Collyrium for Fresh Eyes - Eye Wash Water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated WATER 99.05 mL/100mL N 20181231 24208-276_2fea8a4a-90db-4d2e-90ad-d982828aa936 24208-276 HUMAN OTC DRUG Muro 128 sodium chloride SOLUTION OPHTHALMIC 20110101 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated SODIUM CHLORIDE 20 mg/mL N 20181231 24208-277_7a1293eb-312e-4d97-9a91-db89506d3c65 24208-277 HUMAN OTC DRUG Muro 128 sodium chloride SOLUTION OPHTHALMIC 20110101 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated SODIUM CHLORIDE 50 mg/mL N 20181231 24208-290_d7d4417a-426d-45b3-a11e-baa680974e42 24208-290 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19931129 ANDA ANDA064052 Bausch & Lomb Incorporated TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 24208-295_234383ce-fde8-44a7-b4ae-cd609ebc2650 24208-295 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19991027 ANDA ANDA064134 Bausch & Lomb Incorporated TOBRAMYCIN; DEXAMETHASONE 3; 1 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-299_ae27f407-c1da-4141-8281-2c89ef9ec1fa 24208-299 HUMAN PRESCRIPTION DRUG LOTEMAX loteprednol etabonate SUSPENSION/ DROPS OPHTHALMIC 19980309 NDA NDA020583 Bausch & Lomb Incorporated LOTEPREDNOL ETABONATE 5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-313_f60e9c37-cf77-4b7d-84bf-a95b878f4b27 24208-313 HUMAN OTC DRUG Soothe Night Time white petrolatum mineral oil OINTMENT OPHTHALMIC 20111115 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated MINERAL OIL; PETROLATUM 200; 800 mg/g; mg/g N 20181231 24208-314_7c184cb2-2bd5-4f24-9a38-92ddf2fad086 24208-314 HUMAN PRESCRIPTION DRUG Flurbiprofen Sodium Flurbiprofen Sodium SOLUTION/ DROPS OPHTHALMIC 19950104 ANDA ANDA074447 Bausch & Lomb Incorporated FLURBIPROFEN SODIUM .3 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 24208-315_936bf9de-2c00-4340-8b42-f9c7d75959d2 24208-315 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 19970214 ANDA ANDA064120 Bausch & Lomb Incorporated POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 24208-317_d35f9de0-e138-440e-83c0-9466963c55b2 24208-317 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium and Prednisolone Sodium Phosphate Sulfacetamide Sodium and Prednisolone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19951229 ANDA ANDA074449 Bausch & Lomb Incoporated SULFACETAMIDE SODIUM; PREDNISOLONE SODIUM PHOSPHATE 100; 2.3 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-342_969a64e3-7310-487d-a1e6-d4fcf106e3d2 24208-342 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate SOLUTION NASAL 19990125 ANDA ANDA074830 Bauch & Lomb Incorporated DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 24208-344_69e7e721-ce22-442c-ac61-e9ca802477a1 24208-344 HUMAN PRESCRIPTION DRUG Flunisolide Flunisolide SOLUTION NASAL 20020220 ANDA ANDA074805 Bausch & Lomb Incorporated FLUNISOLIDE .25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-347_a5bc7a5a-a367-4cd4-bc35-4714f0815ae3 24208-347 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19980618 ANDA ANDA075050 Bausch & Lomb Incorporated ALBUTEROL SULFATE 5 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 24208-349_05d695ef-dc81-42d5-ae69-3d3751d71ea2 24208-349 HUMAN OTC DRUG Advanced Eye Relief/ Redness Instant Relief Naphazoline Hydrochloride and Polyethylene glycol 300 SOLUTION/ DROPS OPHTHALMIC 20100913 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated NAPHAZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 300 .1; 2 mg/mL; mg/mL N 20181231 24208-353_57c78944-babf-4e15-a3d9-b02bcd95ddae 24208-353 HUMAN PRESCRIPTION DRUG ALREX loteprednol etabonate SUSPENSION/ DROPS OPHTHALMIC 19980309 NDA NDA020803 Bausch & Lomb Incorporated LOTEPREDNOL ETABONATE 2 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-358_0e91d40c-b306-46b0-90b2-bc015f0f86c5 24208-358 HUMAN PRESCRIPTION DRUG Zylet loteprednol etabonate and tobramycin SUSPENSION/ DROPS OPHTHALMIC 20041214 NDA NDA050804 Bausch & Lomb Incorporated LOTEPREDNOL ETABONATE; TOBRAMYCIN 5; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 24208-367_daabd401-9354-4153-bbb1-03457739dd63 24208-367 HUMAN PRESCRIPTION DRUG CARTEOLOL HYDROCHLORIDE CARTEOLOL HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 20000120 ANDA ANDA075546 Bausch & Lomb Incorporated CARTEOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24208-385_3280dd10-b4fe-439e-b429-97d8e1802c47 24208-385 HUMAN OTC DRUG Muro 128 sodium chloride OINTMENT OPHTHALMIC 20110101 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated SODIUM CHLORIDE 50 mg/g N 20181231 24208-398_c8027b20-a79e-4be1-b535-9df498a10e71 24208-398 HUMAN PRESCRIPTION DRUG Ipratropium bromide Ipratropium bromide SPRAY, METERED NASAL 20030331 ANDA ANDA076025 Bausch & Lomb Incorporated IPRATROPIUM BROMIDE 21 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 24208-399_0f76fe11-3063-4cc0-87a4-57b78489c651 24208-399 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY, METERED NASAL 20030331 ANDA ANDA076103 Bausch & Lomb Incorporated IPRATROPIUM BROMIDE 42 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 24208-410_df580e2b-f6c3-4ae2-92ba-c8a0dd3fe993 24208-410 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20080317 ANDA ANDA076128 Bausch & Lomb Incorporated OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 24208-411_2d2667d3-3b91-4d0c-80ae-2bf8920a0115 24208-411 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate Brimonidine Tartrate SOLUTION/ DROPS OPHTHALMIC 20030528 ANDA ANDA076260 Bausch & Lomb Incorporated BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 24208-416_8911099a-eb1f-4d34-9c30-ec0b3d452094 24208-416 HUMAN PRESCRIPTION DRUG Retisert Fluocinolone Acetonide IMPLANT INTRAVITREAL 20050408 NDA NDA021737 Bausch & Lomb Incorporated FLUOCINOLONE ACETONIDE .59 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-430_94ec6224-2652-4c81-99b5-aab6379e94ad 24208-430 HUMAN OTC DRUG Opcon-A Naphazoline hydrochloride and Pheniramine maleate SOLUTION/ DROPS OPHTHALMIC 19940608 NDA NDA020065 Bausch & Lomb Incorporated NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL N 20181231 24208-433_b8f16da2-6976-4814-8b61-0b29106b8d6c 24208-433 HUMAN OTC DRUG Soothe Hydration povidone SOLUTION OPHTHALMIC 20110502 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated POVIDONE, UNSPECIFIED 12 mg/mL N 20181231 24208-434_ffd3b686-8151-4ef7-ad8c-62391295ee6e 24208-434 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076622 Bausch & Lomb Incorporated OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 24208-443_ee23e23e-0090-4f4f-95dc-bd90848a626f 24208-443 HUMAN PRESCRIPTION DRUG Lotemax loteprednol etabonate OINTMENT OPHTHALMIC 20110415 NDA NDA200738 Bausch & Lomb Incorporated LOTEPREDNOL ETABONATE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-446_af39e710-49f4-4c0a-83a5-a7b574582d3b 24208-446 HUMAN PRESCRIPTION DRUG Besivance Besifloxacin SUSPENSION OPHTHALMIC 20090528 NDA NDA022308 Bausch & Lomb Incorporated BESIFLOXACIN 6 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 24208-450_332e281a-555d-4d1e-8f6b-47a8219a23af 24208-450 HUMAN OTC DRUG Advanced Eye Relief/ Redness Maximum Relief Naphazoline Hydrochloride and Hypromellose SOLUTION/ DROPS OPHTHALMIC 20100902 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated HYPROMELLOSES; NAPHAZOLINE HYDROCHLORIDE 5; .3 mg/mL; mg/mL N 20181231 24208-454_9f84eb14-5c1e-4d0e-a6aa-83dd22841a9a 24208-454 HUMAN OTC DRUG Advanced Eye Relief Dry Eye Rejuvenation glycerin propylene glycol SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated GLYCERIN; PROPYLENE GLYCOL 3; 10 mg/mL; mg/mL N 20181231 24208-457_744bba0c-c972-439e-a19c-f786cf741eeb 24208-457 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20071228 ANDA ANDA078792 Bausch & Lomb Incorporated DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 24208-463_088e6591-cd85-452e-a404-9ae899da7874 24208-463 HUMAN PRESCRIPTION DRUG Latanoprost latanoprost SOLUTION/ DROPS OPHTHALMIC 20110322 ANDA ANDA201006 Bausch & Lomb Incorporated LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 24208-485_185a8685-cd8b-4e08-b6e8-ec04fc83e405 24208-485 HUMAN PRESCRIPTION DRUG Dorzolamide HCl Dorzolamide HCl SOLUTION/ DROPS OPHTHALMIC 20090625 ANDA ANDA090143 Bausch & Lomb Incorporated DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] N 20181231 24208-486_a641e9b9-6aa0-4e17-a72d-5777fa82e119 24208-486 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20090714 ANDA ANDA090037 Bausch & Lomb Incorporated DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24208-490_cd5f61b8-7a4e-42db-9de6-13a4aeec8035 24208-490 HUMAN OTC DRUG Soothe XP light mineral oil and mineral oil SOLUTION/ DROPS OPHTHALMIC 20100826 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated LIGHT MINERAL OIL; MINERAL OIL 10; 45 mg/mL; mg/mL N 20181231 24208-495_5065fa7a-fb70-4258-8b3b-a5eddd86de10 24208-495 HUMAN OTC DRUG Soothe glycerin and propylene glycol SOLUTION/ DROPS OPHTHALMIC 20100826 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated GLYCERIN; PROPYLENE GLYCOL 6; 6 mg/mL; mg/mL N 20181231 24208-503_ab64187e-7927-497b-ab4d-a0380cf9bca3 24208-503 HUMAN PRESCRIPTION DRUG LOTEMAX loteprednol etabonate GEL OPHTHALMIC 20121012 NDA NDA202872 Bausch & Lomb Incorporated LOTEPREDNOL ETABONATE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-504_940dfbb9-5f81-4838-8277-b7d632115a07 24208-504 HUMAN PRESCRIPTION DRUG Vyzulta latanoprostene bunod SOLUTION/ DROPS OPHTHALMIC 20171102 NDA NDA207795 Bausch & Lomb Incorporated LATANOPROSTENE BUNOD .24 mg/mL N 20181231 24208-505_13f92521-4b0a-4f52-8eaa-836c518098b1 24208-505 HUMAN PRESCRIPTION DRUG Levobunolol Hydrochloride Levobunolol Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19940304 ANDA ANDA074326 Bausch & Lomb Incorporated LEVOBUNOLOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24208-535_adf5012d-1077-42c8-ab9d-49ff64abf4a2 24208-535 HUMAN PRESCRIPTION DRUG ZIRGAN ganciclovir GEL OPHTHALMIC 20100430 NDA NDA022211 Bausch & Lomb Incorporated GANCICLOVIR 1.5 mg/g Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 24208-539_c3bf1cb3-63ae-42dc-a4ef-363937798e2a 24208-539 HUMAN PRESCRIPTION DRUG Miochol E acetylcholine chloride KIT 19930922 NDA NDA020213 Bausch & Lomb Incorporated N 20181231 24208-544_6b4a4000-3917-42c0-be73-aef43faa4bd3 24208-544 HUMAN OTC DRUG Soothe Long Lasting Povidone SOLUTION OPHTHALMIC 20130601 OTC MONOGRAPH FINAL part349 Bausch & Lomb Incorporated POVIDONE, UNSPECIFIED 20 mg/mL N 20181231 24208-555_94e18671-a1e4-4ccd-a32d-1cdca2cd62f5 24208-555 HUMAN PRESCRIPTION DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 20080425 ANDA ANDA064046 Bausch & Lomb Incorporated BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] N 20181231 24208-580_3d87eded-a0e0-4c8d-9229-9c537a47c305 24208-580 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 19940511 ANDA ANDA064048 Bausch & Lomb Incorporated GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 24208-585_26269b6b-4f23-44c8-a8e2-5605651d61d4 24208-585 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 19940727 ANDA ANDA040064 Bausch & Lomb Incorporated TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 24208-590_26269b6b-4f23-44c8-a8e2-5605651d61d4 24208-590 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 19940727 ANDA ANDA040067 Bausch & Lomb Incorporated TROPICAMIDE 5 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 24208-601_435911bf-c5ec-49a7-9e82-9405131e381a 24208-601 HUMAN OTC DRUG Alaway Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20061201 NDA NDA021996 Bausch & Lomb Incorporated KETOTIFEN FUMARATE .25 mg/mL N 20181231 24208-602_7a5adc7f-537b-4b92-a008-206fa9c87700 24208-602 HUMAN PRESCRIPTION DRUG Prolensa Bromfenac Sodium SOLUTION/ DROPS OPHTHALMIC 20130405 NDA NDA203168 Bausch & Lomb Incorporated BROMFENAC SODIUM .7 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 24208-615_f0590655-df17-4681-9ffc-f5f02736c8ea 24208-615 HUMAN PRESCRIPTION DRUG Acetic Acid Acetic Acid SOLUTION/ DROPS AURICULAR (OTIC) 19940225 ANDA ANDA040063 Bausch & Lomb Incorporated ACETIC ACID 2 mg/mL N 20181231 24208-629_edb50e66-e407-4d18-874a-4516802a30ed 24208-629 HUMAN PRESCRIPTION DRUG Bepreve bepotastine besilate SOLUTION/ DROPS OPHTHALMIC 20090908 NDA NDA022288 Bausch & Lomb Incorporated BEPOTASTINE BESILATE 15 mg/mL Histamine-1 Receptor Antagonist [EPC] N 20181231 24208-631_74c06e19-8ceb-46a3-9177-6d19f9a4d5ca 24208-631 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Bausch & Lomb Incoporated NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-635_f2d21f36-bde9-4a98-b531-c0c73171d2e3 24208-635 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 Bausch & Lomb Incorporated HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 24208-670_5e0a2e2f-38d6-4309-aee8-f470b5217382 24208-670 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 19941228 ANDA ANDA040066 Bausch & Lomb Incorporated SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 24208-715_c372a925-f602-462f-a3c3-f5b68a599900 24208-715 HUMAN PRESCRIPTION DRUG PREDNISOLONE SODIUM PHOSPHATE PREDNISOLONE SODIUM PHOSPHATE SOLUTION/ DROPS OPHTHALMIC 19940729 ANDA ANDA040070 Bausch & Lomb Incorporated PREDNISOLONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-720_51923140-c0db-4fb3-923d-df6be072d157 24208-720 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19960726 ANDA ANDA040069 Bausch & Lomb Incorporated DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-730_9841bc9d-5bd2-4d39-a25d-6581aa2677b4 24208-730 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19950929 ANDA ANDA040074 Bausch & Lomb Incorporated PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] N 20181231 24208-732_71938df7-eb38-4a21-9267-ea4b355b8c1e 24208-732 HUMAN PRESCRIPTION DRUG Fluorescein Sodium and Benoxinate Hydrochloride Fluorescein Sodium and Benoxinate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19950101 UNAPPROVED DRUG OTHER Bausch & Lomb Incorporated BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM 4; 2.5 mg/mL; mg/mL Diagnostic Dye [EPC],Dyes [MoA] N 20181231 24208-735_eebb54c8-12ba-4534-8918-93a770b5e67f 24208-735 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19940429 ANDA ANDA040075 Bausch & Lomb Incorporated CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL N 20181231 24208-780_05d85d7e-e3f5-483b-9806-093b47f7d752 24208-780 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 Bausch & Lomb Incorporated NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] N 20181231 24208-785_fb0585e1-e176-4524-929f-df5a3fb87320 24208-785 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 19951030 ANDA ANDA064068 Bausch & Lomb Incorporated NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE 3.5; 10000; 400; 10 mg/g; [USP'U]/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-790_266e83a3-21c6-48e1-9dbe-ea6c7371012d 24208-790 HUMAN PRESCRIPTION DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN neomycin sulfate, polymyxin b sulfate and gramicidin SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064047 Bausch & Lomb Incorporated NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN 1.75; 10000; .025 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 24208-795_b7b5c6a5-1f64-44bf-8390-87bd32e520b1 24208-795 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 19940725 ANDA ANDA064063 Bausch & Lomb Incorporated NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/g; [USP'U]/g; mg/g Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 24208-800_b3714b67-261a-40fd-977b-48c688daace1 24208-800 HUMAN PRESCRIPTION DRUG Lacrisert hydroxypropyl cellulose PELLET OPHTHALMIC 19810601 NDA NDA018771 Bausch & Lomb Incorporated HYDROXYPROPYL CELLULOSE (TYPE H) 5 mg/1 Demulcent [EPC],Demulcent Activity [MoA] N 20181231 24208-812_d94af0a6-3941-4769-bfb6-c66312471a24 24208-812 HUMAN PRESCRIPTION DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC 20161230 NDA NDA018086 Bausch & Lomb Incorporated TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 24208-813_d94af0a6-3941-4769-bfb6-c66312471a24 24208-813 HUMAN PRESCRIPTION DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC 20161230 NDA NDA018086 Bausch & Lomb Incorporated TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 24208-814_5de26a0b-884e-467b-af0d-ecd14cf45c0a 24208-814 HUMAN PRESCRIPTION DRUG Timoptic-XE Timolol Maleate SOLUTION OPHTHALMIC 20160531 NDA NDA020330 Bausch & Lomb Incorporated TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24208-816_5de26a0b-884e-467b-af0d-ecd14cf45c0a 24208-816 HUMAN PRESCRIPTION DRUG Timoptic-XE Timolol Maleate SOLUTION OPHTHALMIC 20160531 NDA NDA020330 Bausch & Lomb Incorporated TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24208-825_ffb60cd8-0e95-42f6-ab77-a836e8af48e5 24208-825 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate OINTMENT OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER Bausch & Lomb Incorporated ATROPINE SULFATE 10 mg/g Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 24208-830_e44b3d23-ce14-4797-a81d-711880bd3f6b 24208-830 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 Bausch & Lomb Incorporated NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24208-901_6c33bbfb-9269-46ff-98be-5c20b72bc034 24208-901 HUMAN OTC DRUG Alaway Ketotifen Fumarate KIT 20061201 NDA NDA021996 Bausch & Lomb Incorporated N 20181231 24208-910_effecb3c-87ca-41b2-ab6a-c21ec27b6cc7 24208-910 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 Bausch & Lomb Incorporated ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24208-920_f85139b2-5902-47b0-b715-d02960f3a32a 24208-920 HUMAN PRESCRIPTION DRUG Tetracaine Hydrochloride Tetracaine Hydrochloride SOLUTION OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER Bausch & Lomb Incorporated TETRACAINE HYDROCHLORIDE 5 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 24208-961_3fc807e4-d67b-46dd-8fb6-4f00fb6906d7 24208-961 HUMAN PRESCRIPTION DRUG Cromolyn Sodium cromolyn sodium SOLUTION/ DROPS OPHTHALMIC 19950130 ANDA ANDA074443 Bausch & Lomb Incorporated CROMOLYN SODIUM 40 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 24236-024_4f4806d5-18c8-131e-e054-00144ff88e88 24236-024 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20080512 ANDA ANDA074649 REMEDYREPACK INC. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 24236-025_3d6fb519-b11c-16a4-e054-00144ff8d46c 24236-025 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 20081027 ANDA ANDA075687 REMEDYREPACK INC. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 24236-027_63f271bb-4f6a-bd08-e053-2a91aa0aebb6 24236-027 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20061108 ANDA ANDA084114 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 24236-029_63f3096c-1e50-1a59-e053-2a91aa0a2205 24236-029 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20061110 ANDA ANDA084113 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 24236-033_64051583-0228-4de8-e053-2a91aa0ae08c 24236-033 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20160329 ANDA ANDA063083 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 24236-037_437cb05e-66b7-2630-e054-00144ff88e88 24236-037 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20161202 ANDA ANDA070317 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 24236-045_3e70e5af-4992-49a4-e054-00144ff88e88 24236-045 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20061124 ANDA ANDA070791 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 24236-048_3e715916-92df-03c2-e054-00144ff8d46c 24236-048 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20061114 ANDA ANDA070791 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 24236-066_5267ccbb-dae4-5124-e054-00144ff8d46c 24236-066 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20170620 ANDA ANDA070278 REMEDYREPACK INC. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 24236-075_641910a7-5e82-7170-e053-2a91aa0a0b6a 24236-075 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 20120712 ANDA ANDA088276 REMEDYREPACK INC. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 24236-081_52696436-a2c5-25b4-e054-00144ff8d46c 24236-081 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 20170620 NDA NDA017812 REMEDYREPACK INC. LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] N 20181231 24236-082_50733d7f-776f-42f6-e054-00144ff8d46c 24236-082 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 20100812 NDA NDA018558 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 24236-112_4aca7f75-5e7c-472c-e054-00144ff88e88 24236-112 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20131011 ANDA ANDA071973 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24236-115_36fb11a6-f0e0-6f17-e054-00144ff88e88 24236-115 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20090928 ANDA ANDA070791 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 24236-127_5278490f-837f-295d-e054-00144ff88e88 24236-127 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20170621 ANDA ANDA071525 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 24236-128_5278a128-41b8-4494-e054-00144ff8d46c 24236-128 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20170621 ANDA ANDA071523 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 24236-170_6378ca96-02bc-5176-e053-2a91aa0aecf8 24236-170 HUMAN OTC DRUG Aspir Low Aspirin TABLET ORAL 20061110 OTC MONOGRAPH FINAL part343 REMEDYREPACK INC. ASPIRIN 81 mg/1 N 20191231 24236-181_64454469-abdb-da31-e053-2991aa0a7075 24236-181 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20070523 ANDA ANDA084112 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 24236-218_36f97c68-6180-3617-e054-00144ff8d46c 24236-218 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20070409 ANDA ANDA071206 REMEDYREPACK INC. HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] E 20171231 24236-225_6481bab4-1018-f99c-e053-2a91aa0a1ccf 24236-225 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20070410 NDA NDA018723 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 24236-253_505ee941-2932-35e4-e054-00144ff88e88 24236-253 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20161020 ANDA ANDA070278 REMEDYREPACK INC. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 24236-258_6364164c-f2f1-d007-e053-2991aa0a0115 24236-258 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20070418 ANDA ANDA084114 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 24236-262_7b5ccd45-650b-4165-9ace-75b3231ca140 24236-262 HUMAN PRESCRIPTION DRUG GEODON ZIPRASIDONE HYDROCHLORIDE CAPSULE ORAL 20101220 NDA NDA020825 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 24236-272_3ada9262-7e85-3dca-e054-00144ff88e88 24236-272 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20070420 ANDA ANDA040209 REMEDYREPACK INC. TRIFLUOPERAZINE HYDROCHLORIDE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 24236-274_505ec046-fdf7-3156-e054-00144ff88e88 24236-274 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20070423 ANDA ANDA071207 REMEDYREPACK INC. HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] N 20181231 24236-278_375e802a-9c5d-1c71-e054-00144ff88e88 24236-278 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 20070424 ANDA ANDA071093 REMEDYREPACK INC. THIOTHIXENE 10 mg/1 Typical Antipsychotic [EPC] E 20171231 24236-313_3c506783-46fd-0395-e054-00144ff88e88 24236-313 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 20160912 NDA NDA020241 REMEDYREPACK INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 24236-323_636486cb-e1e0-a7f2-e053-2991aa0ad17e 24236-323 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20070504 ANDA ANDA084112 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 24236-345_528fd975-f95c-011d-e054-00144ff8d46c 24236-345 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20170622 ANDA ANDA070278 REMEDYREPACK INC. HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] N 20181231 24236-349_3770da64-ae0f-2e4c-e054-00144ff88e88 24236-349 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 20070516 ANDA ANDA071093 REMEDYREPACK INC. THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] E 20171231 24236-354_5073489d-1eae-3e59-e054-00144ff8d46c 24236-354 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20070517 ANDA ANDA080937 REMEDYREPACK INC. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 24236-370_513ec713-f8fd-3cf0-e054-00144ff8d46c 24236-370 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20070601 ANDA ANDA071972 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24236-373_3e8721e8-f403-2201-e054-00144ff8d46c 24236-373 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20070906 ANDA ANDA071136 REMEDYREPACK INC. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 24236-376_528ffc5c-0209-70e0-e054-00144ff88e88 24236-376 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170622 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 24236-403_4e23eb68-9b56-6397-e054-00144ff88e88 24236-403 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20070622 ANDA ANDA071972 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24236-405_529097a3-cd3c-0d1a-e054-00144ff88e88 24236-405 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20170622 ANDA ANDA080352 REMEDYREPACK INC. PREDNISONE 5 mg/1 N 20181231 24236-411_529097a3-cd96-0d1a-e054-00144ff88e88 24236-411 HUMAN PRESCRIPTION DRUG Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20170622 NDA NDA021168 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 24236-417_4aca5a39-f78c-5cb6-e054-00144ff8d46c 24236-417 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 20070627 ANDA ANDA073229 REMEDYREPACK INC. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 24236-449_50ebb5f9-5a35-4df0-e054-00144ff8d46c 24236-449 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070718 ANDA ANDA078250 REMEDYREPACK INC. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 24236-464_63a1e384-01c5-5edb-e053-2991aa0aba64 24236-464 HUMAN OTC DRUG Enteric Coated Stimulant Laxative Bisacodyl TABLET, DELAYED RELEASE ORAL 20180125 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. BISACODYL 5 mg/1 N 20191231 24236-475_3e88092d-15ea-1744-e054-00144ff88e88 24236-475 HUMAN OTC DRUG Fiber Lax Calcium Polycarbophil TABLET, FILM COATED ORAL 20070816 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. CALCIUM POLYCARBOPHIL 625 mg/1 E 20171231 24236-479_50732645-aa18-3bef-e054-00144ff8d46c 24236-479 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20070817 ANDA ANDA086066 REMEDYREPACK INC. ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 24236-504_52914ac0-bf2f-1cdf-e054-00144ff88e88 24236-504 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 20170622 NDA NDA020272 REMEDYREPACK INC. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 24236-517_4fd3a6f1-4bc1-5812-e054-00144ff8d46c 24236-517 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20070906 ANDA ANDA083116 REMEDYREPACK INC. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 24236-523_5f8ab159-7b61-b3f2-e053-2a91aa0ae2d7 24236-523 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070905 ANDA ANDA074342 REMEDYREPACK INC. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 24236-567_3e88301f-eb0e-2095-e054-00144ff88e88 24236-567 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20071009 ANDA ANDA073553 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 24236-601_375d205d-b0d5-6570-e054-00144ff88e88 24236-601 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20071119 ANDA ANDA083745 REMEDYREPACK INC. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 24236-609_9f34fbe6-b2a6-4bd0-8e1f-8243459b14f9 24236-609 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20111205 ANDA ANDA076003 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 24236-609_f626bc03-2b5e-45ee-b06d-6628b7cde087 24236-609 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20130731 ANDA ANDA076003 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 24236-652_36fb05a7-78aa-6b46-e054-00144ff88e88 24236-652 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080429 ANDA ANDA071208 REMEDYREPACK INC. HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] E 20171231 24236-661_3e88eeb7-b97a-73a5-e054-00144ff8d46c 24236-661 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20080506 ANDA ANDA040209 REMEDYREPACK INC. TRIFLUOPERAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 24236-687_513e911a-e17e-336c-e054-00144ff8d46c 24236-687 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 20080521 ANDA ANDA081319 REMEDYREPACK INC. PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] N 20181231 24236-698_4ab77f19-dad3-07b5-e054-00144ff8d46c 24236-698 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20080529 ANDA ANDA070177 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24236-732_3eb11fc8-3aa4-5d77-e054-00144ff88e88 24236-732 HUMAN OTC DRUG Bisacodyl Enteric Coated Bisacodyl TABLET, COATED ORAL 20080630 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. BISACODYL 5 mg/1 E 20171231 24236-734_3ed6bf70-2848-04f8-e054-00144ff8d46c 24236-734 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20150417 OTC MONOGRAPH FINAL part343 REMEDYREPACK INC. ASPIRIN 325 mg/1 E 20171231 24236-735_377268a8-678d-03be-e054-00144ff8d46c 24236-735 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20080630 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. DOCUSATE SODIUM 100 mg/1 E 20171231 24236-771_53188c41-3f18-311b-e054-00144ff88e88 24236-771 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20170629 NDA NDA018723 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 24236-783_59a8bcbc-ecc9-dc3a-e053-2a91aa0a0b4f 24236-783 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20160809 NDA NDA021446 REMEDYREPACK INC. PREGABALIN 50 mg/1 N 20181231 24236-800_4fd34bb1-73d4-3128-e054-00144ff88e88 24236-800 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20080829 ANDA ANDA084768 REMEDYREPACK INC. CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 24236-815_4ce8655c-4b13-546e-e054-00144ff8d46c 24236-815 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20081105 ANDA ANDA076690 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 24236-816_514292bf-6b28-0d33-e054-00144ff88e88 24236-816 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20080918 NDA NDA022047 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 24236-841_531a253b-f26b-358e-e054-00144ff8d46c 24236-841 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20170629 ANDA ANDA071525 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 24236-849_3eaf2fc1-1626-3546-e054-00144ff8d46c 24236-849 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 20081013 ANDA ANDA086831 REMEDYREPACK INC. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 24236-861_532c0685-42da-23ac-e054-00144ff8d46c 24236-861 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20170630 ANDA ANDA072575 REMEDYREPACK INC. PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 24236-870_532d43a7-6caa-11d6-e054-00144ff88e88 24236-870 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20170630 ANDA ANDA077802 REMEDYREPACK INC. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 24236-879_3ead816a-3242-5997-e054-00144ff88e88 24236-879 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20081029 ANDA ANDA089683 REMEDYREPACK INC. PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 24236-885_532d5f23-82ce-2412-e054-00144ff88e88 24236-885 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20170630 ANDA ANDA077802 REMEDYREPACK INC. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 24236-913_532df1d6-0338-7227-e054-00144ff8d46c 24236-913 HUMAN PRESCRIPTION DRUG Effexor XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20170630 NDA NDA020699 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 24236-963_5036e5b2-ac4e-331e-e054-00144ff88e88 24236-963 HUMAN PRESCRIPTION DRUG Effexor XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090119 NDA NDA020699 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 24236-979_5332da47-0dff-610a-e054-00144ff8d46c 24236-979 HUMAN PRESCRIPTION DRUG Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20170630 NDA NDA021168 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 24236-983_4df0c849-dc4b-353e-e054-00144ff8d46c 24236-983 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20090225 ANDA ANDA085762 REMEDYREPACK INC. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 24236-984_53be816b-29c3-622c-e054-00144ff8d46c 24236-984 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 20170707 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 24275-0185_7fd55db9-1362-4b1d-9e2a-8a97c034f7fd 24275-0185 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20111204 ANDA ANDA203902 UCSF Radiopharmaceutical Facility FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24275-0285_338dcd9a-0735-4a35-b8d2-55735114fe6e 24275-0285 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20091101 ANDA ANDA204437 UCSF Radiopharmaceutical Facility SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24275-0385_4b973cd4-37c3-4107-b37c-ccca43795974 24275-0385 HUMAN PRESCRIPTION DRUG Ammonia N 13 NH3N13 INJECTION INTRAVENOUS 20081106 ANDA ANDA204496 UCSF Radiopharmaceutical Facility AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24275-0485_5f4c1a62-fb20-8cdc-e053-2a91aa0a671a 24275-0485 HUMAN PRESCRIPTION DRUG Choline C 11 Choline C-11 INJECTION INTRAVENOUS 20171127 ANDA ANDA208444 UCSF Radiopharmaceutical Facility CHOLINE C-11 33.1 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24286-1520_3a3e8d1f-2a67-426b-9620-ed4484d1b5ce 24286-1520 HUMAN OTC DRUG Bactimicina for Sore Throat BENZOCAINE LOZENGE ORAL 20110524 OTC MONOGRAPH NOT FINAL part356 DLC Laboratories, Inc. BENZOCAINE 15 mg/1 N 20181231 24286-1521_4717b40c-422d-45e7-b366-df2ebb217fd9 24286-1521 HUMAN OTC DRUG De La Cruz Camphor CAMPHOR OINTMENT TOPICAL 20120726 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc. CAMPHOR (SYNTHETIC) 11 g/100g N 20181231 24286-1523_128874bc-53c4-46b9-872e-4b9e7c1ad097 24286-1523 HUMAN OTC DRUG De La Cruz Desempacho SODIUM BICARBONATE LIQUID ORAL 20160315 OTC MONOGRAPH FINAL part331 DLC LABORATORIES, INC. SODIUM BICARBONATE 525 mg/15mL N 20181231 24286-1525_57cdfa02-2f08-4307-86ea-4c5fb5adddf7 24286-1525 HUMAN OTC DRUG De La Cruz Sulfur Acne Medication SULFUR OINTMENT TOPICAL 20140811 OTC MONOGRAPH FINAL part333D DLC Laboratories, Inc. SULFUR 10 g/100g N 20181231 24286-1526_923ac6fc-7f92-4c9a-8fda-e219082074ca 24286-1526 HUMAN OTC DRUG De La Cruz Castor Oil CASTOR OIL OIL ORAL 20120727 OTC MONOGRAPH NOT FINAL part334 DLC Laboratories, Inc. CASTOR OIL 1 g/mL N 20181231 24286-1528_5d8f56c7-3068-88fd-e053-2a91aa0ac73e 24286-1528 HUMAN OTC DRUG De La Cruz Tincture of Iodine Iodine and Sodium Iodide and Alcohol LIQUID TOPICAL 19790101 OTC MONOGRAPH NOT FINAL part333A DLC Laboratories, Inc. IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 24286-1529_0506e2d9-73d3-457a-9992-ca087090c26f 24286-1529 HUMAN OTC DRUG De La Cruz Decolorized Iodine Ethyl Alcohol LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A DLC Laboratories, Inc. ALCOHOL .45 mL/mL N 20191231 24286-1531_60655eed-f305-2247-e053-2a91aa0ae079 24286-1531 HUMAN OTC DRUG DE LA CRUZ GENTIAN VIOLET GENTIAN VIOLET TINCTURE TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E DLC Laboratories, Inc. GENTIAN VIOLET 1 g/100mL N 20181231 24286-1532_603ebb62-04a7-2325-e053-2a91aa0a8696 24286-1532 HUMAN OTC DRUG Tincture Merthiolate BENZALKONIUM CHLORIDE TINCTURE TOPICAL 20130322 OTC MONOGRAPH NOT FINAL part333A DLC Laboratories, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 24286-1533_af97e5eb-3666-46c7-be59-a158127dd385 24286-1533 HUMAN OTC DRUG QUITA COLICOS GAS RELIEF DROPS Simethicone LIQUID ORAL 20140318 OTC MONOGRAPH FINAL part332 DLC Laboratories, Inc. DIMETHICONE 20 mg/.3mL N 20181231 24286-1537_f69fbfa8-a947-4b9b-9186-a37c34563d96 24286-1537 HUMAN OTC DRUG DE LA CRUZ SODIUM BICARBONATE ANTACID SODIUM BICARBONATE POWDER ORAL 20130925 OTC MONOGRAPH FINAL part331 DLC Laboratories, Inc. SODIUM BICARBONATE 2.6 g/2.6g N 20181231 24286-1546_395166d9-fbad-41f0-a96a-1c9f0c0679e5 24286-1546 HUMAN OTC DRUG BACTIMICINA COUGH AND COLD DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE SOLUTION ORAL 20131106 OTC MONOGRAPH FINAL part341 DLC Laboratories, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 24286-1550_9c54914d-137d-4d05-875a-6cf60421e69a 24286-1550 HUMAN OTC DRUG Bactimicina Childrens Pain and Fever ACETAMINOPHEN LIQUID ORAL 20141117 OTC MONOGRAPH NOT FINAL part343 DLC Laboratories, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 24286-1551_e6ea48fa-3488-475a-b8b1-63f76579b136 24286-1551 HUMAN OTC DRUG Bactimicina Childrens Cough and Cold CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20091023 OTC MONOGRAPH FINAL part341 DLC Laboratories, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 1; 7.5 mg/5mL; mg/5mL N 20181231 24286-1552_83f516d6-7aa5-482f-a597-77d527f89bea 24286-1552 HUMAN OTC DRUG PURGASOL Sennosides Docusate Sodium TABLET ORAL 20091116 OTC MONOGRAPH NOT FINAL part334 DLC Laboratories, Inc. SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 24286-1553_2c9e57aa-afcd-4916-be9c-455316e968ba 24286-1553 HUMAN OTC DRUG De La Cruz Mercurochrome BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20110630 OTC MONOGRAPH NOT FINAL part333A DLC Laboratories, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; 2.5 mL/100mL; mL/100mL E 20171231 24286-1554_907250f2-710d-4a33-91d4-ee313c8f2802 24286-1554 HUMAN OTC DRUG Earths Care Pain Relieving CAMPHOR, MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20111129 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 4; 10; 15 g/100g; g/100g; g/100g N 20181231 24286-1555_2e1cf59c-4200-466c-be94-d247392b0c7f 24286-1555 HUMAN OTC DRUG Earths Care Arnica Compound CAMPHOR OINTMENT TOPICAL 20120222 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc. CAMPHOR (NATURAL) 3 g/100g N 20181231 24286-1556_119663ec-04f8-4a8d-9c4b-195e6e513996 24286-1556 HUMAN OTC DRUG Earths Care Acne Treatment Mask SULFUR CREAM TOPICAL 20130118 OTC MONOGRAPH FINAL part333D DLC Laboratories, Inc. SULFUR 5 g/100g N 20181231 24286-1557_ed627ee7-f85b-4b09-8975-43481b80c815 24286-1557 HUMAN OTC DRUG Earths Care Acne Spot Treatment SULFUR CREAM TOPICAL 20130118 OTC MONOGRAPH FINAL part333D DLC Laboratories, Inc. SULFUR 10 g/100g N 20181231 24286-1558_770e3b75-8a06-4297-9baf-9782d98581ce 24286-1558 HUMAN OTC DRUG EARTHS CARE ANTI-ITCH CAMPHOR (NATURAL), MENTHOL CREAM TOPICAL 20131030 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc. CAMPHOR (NATURAL); MENTHOL .5; 1 g/100g; g/100g N 20181231 24286-1559_413352a5-6cc0-4553-be42-05e5ae4b05c9 24286-1559 HUMAN OTC DRUG EARTHS CARE ARTHRITIS CREAM CAPSAICIN CREAM TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc. CAPSAICIN .1 g/100g N 20181231 24286-1560_b1f5b320-98db-4c06-89a6-b0767da14385 24286-1560 HUMAN OTC DRUG Maximum Strength Hydrocortisone HYDROCORTISONE OINTMENT TOPICAL 20130322 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc HYDROCORTISONE 1 g/100g N 20181231 24286-1561_d2b81f9f-5c9a-408e-8a70-ccc5f9925848 24286-1561 HUMAN OTC DRUG Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20110201 OTC MONOGRAPH FINAL part358G DLC Laboratories, Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 24286-1562_336e3903-7466-4904-a0fa-ca0e86fd1489 24286-1562 HUMAN OTC DRUG Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20110201 OTC MONOGRAPH FINAL part358G DLC Laboratories, Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 24286-1563_774a3e7a-2998-42a8-ad97-6508a6c6f265 24286-1563 HUMAN OTC DRUG EARTHS CARE MUSCLE AND JOINT RUB camphor OINTMENT TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part348 DLC Laboratories, Inc. CAMPHOR (NATURAL) 3 g/100g N 20181231 24286-1564_d633f94b-838f-46e0-a89e-8ab65301fe2b 24286-1564 HUMAN OTC DRUG VAPOREX CAMPHOR (SYNTHETIC), EUCALYPTUS Oil, and MENTHOL OINTMENT TOPICAL 20130312 OTC MONOGRAPH FINAL part341 DLC Laboratories, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL, UNSPECIFIED FORM 4.8; 1.2; 2.6 g/100g; g/100g; g/100g N 20181231 24286-1565_f79cf00e-83b8-4739-9ae9-0b753d05ebfc 24286-1565 HUMAN OTC DRUG BACTIMICINA CHILDRENS ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20150617 OTC MONOGRAPH FINAL part341 DLC Laboratories, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 24286-1566_3d0e2299-e239-43ef-b7d6-ffea2116efe1 24286-1566 HUMAN OTC DRUG DE LA CRUZ DIAPER RASH ALLANTOIN, PETROLATUM, and ZINC OXIDE OINTMENT TOPICAL 20150710 OTC MONOGRAPH FINAL part347 DLC Laboratories, Inc. ALLANTOIN; PETROLATUM; ZINC OXIDE 1; 45; 40 g/100g; g/100g; g/100g N 20181231 24286-1567_1e15ca0d-d1a2-1bd0-e054-00144ff8d46c 24286-1567 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20090606 ANDA ANDA076134 DLC Laboratories, Inc LORATADINE 10 mg/1 N 20181231 24286-1568_46dbccd8-549e-3c4a-e054-00144ff8d46c 24286-1568 HUMAN OTC DRUG Allergy Relief Loratadine TABLET ORAL 20160501 ANDA ANDA076471 DLC LABORATORIES, INC LORATADINE 10 mg/1 N 20181231 24286-1569_9e35610a-2d20-45d5-b352-4173c63a3b70 24286-1569 HUMAN OTC DRUG Earths Care Eczema Oatmeal LOTION TOPICAL 20170308 OTC MONOGRAPH FINAL part347 DLC Laboratories, Inc. OATMEAL 1.8 g/100mL N 20191231 24286-1570_1b33170f-6313-4ffb-81c6-ec45a8e9f8a1 24286-1570 HUMAN OTC DRUG Earths Care Hemorrhoid Relief Witch Hazel and Menthol, Unspecified Form CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part347 DLC Laboratories, Inc. WITCH HAZEL; MENTHOL, UNSPECIFIED FORM 10; .8 g/100g; g/100g N 20181231 24286-5191_7374d2b2-bd66-4f23-95bb-4d7e6a3cf71f 24286-5191 HUMAN OTC DRUG Colirio Ocusan Polyethlene glycol 400 Tetrahydrozoline HCl LIQUID OPHTHALMIC 20110831 OTC MONOGRAPH FINAL part349 DLC Laboratories, Inc. POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE 10; .5 mg/mL; mg/mL N 20181231 24286-5292_852c9a13-822a-4990-872f-ba161c1dc56e 24286-5292 HUMAN OTC DRUG Tears lubricant glycerin, hypromellose, polyethylene glycol 400 LIQUID OPHTHALMIC 20110831 OTC MONOGRAPH FINAL part349 DLC Laboratories, Inc. GLYCERIN; POLYETHYLENE GLYCOL 400; HYPROMELLOSES 2; 10; 2 mg/mL; mg/mL; mg/mL N 20181231 24306-123_f633a4e5-92f8-41d9-a71a-01d014e643cc 24306-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Cylinder Maintenabce and Supply, Inc OXYGEN 99 L/100L E 20171231 24312-001_c6d9febc-427e-4ce8-8271-7d3dfa780dc4 24312-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20040101 NDA NDA205712 Airtec Gases, LLC OXYGEN 99 L/100L N 20181231 24312-002_fd02da69-0fac-4076-a854-db54ab005247 24312-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20040101 NDA NDA205713 Airtec Gases, LLC NITROGEN 99 L/100L N 20181231 24312-003_d6b10be4-fdb9-4041-b8e5-f8d28921109f 24312-003 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 20040101 NDA NDA205704 Airtec Gases, LLC NITROUS OXIDE 99 L/100L N 20181231 24319-0001_08a259ad-7b46-49c0-b312-bd8a019bc224 24319-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060201 UNAPPROVED MEDICAL GAS Homeside Healthcare, Inc. OXYGEN 99 L/100L E 20171231 24330-110_778699fa-4226-4ebb-8c47-cde4725e4ddb 24330-110 HUMAN OTC DRUG First Degree Calendula Officinalis, Echinacea Angustifolia, Cantharis Vesicatoria TINCTURE TOPICAL 20070101 UNAPPROVED HOMEOPATHIC Welmedix LLC CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; LYTTA VESICATORIA 1; 1; 3 [hp_Q]/.1g; [hp_Q]/.1g; [hp_X]/.1g N 20181231 24330-111_8bbc5057-7e59-4b84-ab30-b775b1a18dd3 24330-111 HUMAN OTC DRUG First Degree Burn benzocaine, triclosan SPRAY TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part348 The Akshay Wellness Group, Inc. BENZOCAINE; TRICLOSAN 200; 1.3 mg/mL; mg/mL N 20181231 24330-130_cbfe71fd-2d5c-4c98-8caf-68fe49e54b6f 24330-130 HUMAN OTC DRUG First Degree Maximum Strength Burn Pramoxine Hydrochloride CREAM TOPICAL 20170309 OTC MONOGRAPH NOT FINAL part348 Welmedix LLC PRAMOXINE HYDROCHLORIDE 10 mg/g N 20181231 24330-210_ff613184-c8e5-4bad-b32f-dff820f04f9d 24330-210 HUMAN OTC DRUG SUNBURNT Calendula Officinalis, Echinacea Angustifolia, Cantharis Vesicatoria TINCTURE TOPICAL 20070101 UNAPPROVED HOMEOPATHIC Welmedix LLC CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; LYTTA VESICATORIA 1; 1; 3 [hp_Q]/.1g; [hp_Q]/.1g; [hp_X]/.1g E 20171231 24330-410_8bdf914e-ab9b-44b7-b977-e4ef21d652ab 24330-410 HUMAN OTC DRUG Welmedix HomeCare PRO Extra Strength Rapid Rash Relief Petrolatum, Zinc Oxide CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part347 Welmedix Llc PETROLATUM; ZINC OXIDE 49; 15 g/100g; g/100g N 20181231 24330-412_90453774-fb23-4999-bb18-a977c986e6c2 24330-412 HUMAN OTC DRUG Welmedix HomeCare PRO Fragile Skin Protectant Petrolatum OINTMENT TOPICAL 20130401 OTC MONOGRAPH FINAL part347 Welmedix Llc PETROLATUM 42 g/100g N 20181231 24338-010_a73a78ca-104d-4dc3-a508-463b13fe161b 24338-010 HUMAN PRESCRIPTION DRUG BiDil Hydralazine hydrochloride and Isosorbide dinitrate TABLET, FILM COATED ORAL 20121205 NDA NDA020727 Arbor Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE 37.5; 20 mg/1; mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 24338-022_a02475c2-f41e-4268-9c90-a2a2089ed0a0 24338-022 HUMAN PRESCRIPTION DRUG Evekeo Amphetamine Sulfate TABLET ORAL 20151101 ANDA ANDA200166 Arbor Pharmaceuticals AMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24338-026_a02475c2-f41e-4268-9c90-a2a2089ed0a0 24338-026 HUMAN PRESCRIPTION DRUG Evekeo Amphetamine Sulfate TABLET ORAL 20151101 ANDA ANDA200166 Arbor Pharmaceuticals AMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24338-050_69c3cd33-3b38-488f-ac50-e06d96a2a721 24338-050 HUMAN PRESCRIPTION DRUG Gliadel carmustine WAFER INTRACAVITARY 20121213 NDA NDA020637 Arbor Pharmaceuticals CARMUSTINE 7.7 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 24338-080_736bbfd0-1fbd-4615-80f6-3f5f1ae12284 24338-080 HUMAN PRESCRIPTION DRUG OTOVEL (ciprofloxacin and fluocinolone acetonide) FOR SOLUTION AURICULAR (OTIC) 20160429 NDA NDA208251 Arbor Pharmaceuticals CIPROFLOXACIN; FLUOCINOLONE ACETONIDE; POLYSORBATE 80 872.5; 62.5; 6250 ug/.25mL; ug/.25mL; ug/.25mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24338-100_ae8f4e4d-bd07-45ea-80bf-6052d5187d26 24338-100 HUMAN PRESCRIPTION DRUG E.E.S 400 Erythromycin Ethylsuccinate TABLET ORAL 20110503 ANDA ANDA061905 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 400 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-102_32ab725b-87a8-4e5b-92d8-e47863920f75 24338-102 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-104_32ab725b-87a8-4e5b-92d8-e47863920f75 24338-104 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-106_8bb04897-b479-4077-8610-ff24ff4cdbee 24338-106 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET, FILM COATED ORAL 20110801 ANDA ANDA060359 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-110_0e71bd91-7dc4-4245-85c8-bad07d782fba 24338-110 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ETHYLSUCCINATE Erythromycin Ethylsuccinate TABLET ORAL 20111003 ANDA ANDA061904 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 400 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-112_2742a78f-022f-4c97-be6f-f97c4a7c4527 24338-112 HUMAN PRESCRIPTION DRUG PCE ERYTHROMYCIN ETHYLSUCCINATE TABLET ORAL 20111005 NDA NDA050611 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-114_2742a78f-022f-4c97-be6f-f97c4a7c4527 24338-114 HUMAN PRESCRIPTION DRUG PCE ERYTHROMYCIN ETHYLSUCCINATE TABLET ORAL 20111005 NDA NDA050611 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-120_98e41f94-ac95-40e6-b7f5-39dc5e696a9a 24338-120 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN Erythromycin CAPSULE, DELAYED RELEASE ORAL 20120110 ANDA ANDA062746 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-122_ed6a7317-dc35-4f60-a782-efa06d49eac8 24338-122 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-124_ed6a7317-dc35-4f60-a782-efa06d49eac8 24338-124 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-126_ed6a7317-dc35-4f60-a782-efa06d49eac8 24338-126 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-130_97846f49-4484-46c0-9093-ceaaa1a81cc8 24338-130 HUMAN PRESCRIPTION DRUG Ery-Ped Erythromycin Ethylsuccinate SUSPENSION ORAL 20120614 NDA NDA050207 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 400 mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-132_97846f49-4484-46c0-9093-ceaaa1a81cc8 24338-132 HUMAN PRESCRIPTION DRUG Ery-Ped Erythromycin Ethylsuccinate SUSPENSION ORAL 20110705 NDA NDA050207 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-134_ae8f4e4d-bd07-45ea-80bf-6052d5187d26 24338-134 HUMAN PRESCRIPTION DRUG E.E.S Erythromycin Ethylsuccinate GRANULE, FOR SUSPENSION ORAL 20110418 NDA NDA050207 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-136_ae8f4e4d-bd07-45ea-80bf-6052d5187d26 24338-136 HUMAN PRESCRIPTION DRUG E.E.S Erythromycin Ethylsuccinate GRANULE, FOR SUSPENSION ORAL 20110418 NDA NDA050207 Arbor Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 24338-150_d68b309b-41fb-4055-a3f4-4c405ac491df 24338-150 HUMAN PRESCRIPTION DRUG TRIPTODUR triptorelin KIT 20170908 NDA NDA208956 Arbor Pharmaceuticals, LLC N 20181231 24338-183_1b5d3e2e-2d3c-47ab-991b-258942dcf6c4 24338-183 HUMAN PRESCRIPTION DRUG Sklice IVERMECTIN LOTION TOPICAL 20160630 NDA NDA202736 Arbor Pharmaceuticals IVERMECTIN 5 mg/g Antiparasitic [EPC],Pediculicide [EPC] N 20181231 24338-200_c30dff05-7f5d-49ef-8bf1-9d39b09e41b6 24338-200 HUMAN PRESCRIPTION DRUG Nymalize nimodipine SOLUTION ORAL 20130603 NDA NDA203340 Arbor Pharmaceuticals NIMODIPINE 60 mg/20mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 24338-205_c30dff05-7f5d-49ef-8bf1-9d39b09e41b6 24338-205 HUMAN PRESCRIPTION DRUG Nymalize nimodipine SOLUTION ORAL 20170406 NDA NDA203340 Arbor Pharmaceuticals NIMODIPINE 30 mg/10mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 24338-430_6c8f74e8-91c7-4670-8034-a57cb6ea8985 24338-430 HUMAN PRESCRIPTION DRUG Pediaderm TA Triamcinolone Acetonide CREAM TOPICAL 20100901 ANDA ANDA040039 Arbor Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24338-530_d49cb493-9806-4471-b356-48773f423932 24338-530 HUMAN PRESCRIPTION DRUG SOTYLIZE SOTALOL HYDROCHLORIDE SOLUTION ORAL 20150301 NDA NDA205108 Arbor Pharmaceuticals, Inc. SOTALOL HYDROCHLORIDE 5 mg/mL Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 24338-700_6acbc65b-c701-4365-8335-d1ec95dacf31 24338-700 HUMAN PRESCRIPTION DRUG Cetylev acetylcysteine TABLET, EFFERVESCENT ORAL 20160627 NDA NDA207916 Arbor Pharmaceuticals ACETYLCYSTEINE 500 mg/1 Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 24338-707_6acbc65b-c701-4365-8335-d1ec95dacf31 24338-707 HUMAN PRESCRIPTION DRUG Cetylev acetylcysteine TABLET, EFFERVESCENT ORAL 20170213 NDA NDA207916 Arbor Pharmaceuticals ACETYLCYSTEINE 2.5 g/1 Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 24338-725_6acbc65b-c701-4365-8335-d1ec95dacf31 24338-725 HUMAN PRESCRIPTION DRUG Cetylev acetylcysteine TABLET, EFFERVESCENT ORAL 20160627 NDA NDA207916 Arbor Pharmaceuticals ACETYLCYSTEINE 2.5 g/1 Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 24338-850_045657fd-57e6-4baf-bfaf-f3ecd3dfc1c2 24338-850 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20130531 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24338-851_045657fd-57e6-4baf-bfaf-f3ecd3dfc1c2 24338-851 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20130531 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24338-852_045657fd-57e6-4baf-bfaf-f3ecd3dfc1c2 24338-852 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20130531 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 7.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24338-853_045657fd-57e6-4baf-bfaf-f3ecd3dfc1c2 24338-853 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20130531 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24338-854_045657fd-57e6-4baf-bfaf-f3ecd3dfc1c2 24338-854 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20140501 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24338-855_045657fd-57e6-4baf-bfaf-f3ecd3dfc1c2 24338-855 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20140501 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24338-856_045657fd-57e6-4baf-bfaf-f3ecd3dfc1c2 24338-856 HUMAN PRESCRIPTION DRUG Zenzedi Dextroamphetamine Sulfate TABLET ORAL 20140501 ANDA ANDA090533 Arbor Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24357-701_5d90883a-5738-6a0e-e053-2991aa0a3403 24357-701 HUMAN OTC DRUG Anecream Lidocaine 4% CREAM TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part348 Focus Health Group LIDOCAINE 4 g/100g N 20181231 24357-702_5d8f551b-2800-0277-e053-2991aa0ab266 24357-702 HUMAN OTC DRUG Anecream 5 Lidocaine 5% CREAM TOPICAL 20111220 OTC MONOGRAPH FINAL part346 Focus Health Group LIDOCAINE 5 g/100g N 20181231 24357-811_580d1baa-cfde-f3e7-e053-2a91aa0ac059 24357-811 HUMAN PRESCRIPTION DRUG epinephrinesnap-v Epinephrine Convenience Kit KIT 20170505 UNAPPROVED DRUG OTHER FOCUS HEALTH GROUP N 20181231 24357-911_46dd7b1d-5dd0-584b-e054-00144ff88e88 24357-911 HUMAN PRESCRIPTION DRUG EPIsnap Epinephrine Convenience Kit EPIsnap Epinephrine Convenience Kit INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20150901 UNAPPROVED DRUG OTHER Focus Health Group EPINEPHRINE 1 mg/1000mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 24385-003_5d07274f-e849-6c60-e053-2991aa0a40d8 24385-003 HUMAN OTC DRUG GNP Gentian Violet 1% Gentian Violet 1% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Amerrisource Bergen GENTIAN VIOLET 10 mg/mL N 20181231 24385-004_cecc4579-814f-4a23-aa7e-75409621c60d 24385-004 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 20100709 OTC MONOGRAPH FINAL part336 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 DIMENHYDRINATE 50 mg/1 N 20181231 24385-005_9faf81cf-4921-41f7-997e-4372fd1e28ae 24385-005 HUMAN OTC DRUG Good Neighbor Pharmacy Day Time acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20060720 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 24385-006_1f288363-61d8-4b94-9f79-fc7c638f2a52 24385-006 HUMAN OTC DRUG Good Neighbor Pharmacy Artifical Tears Lubricant Eye Drops Polyvinyl alcohol, Povidone SOLUTION/ DROPS INTRAOCULAR 20010129 OTC MONOGRAPH FINAL part349 AmerisourceBergen Drug Corporation POLYVINYL ALCOHOL; POVIDONE .5; .6 g/100mL; g/100mL N 20181231 24385-009_871bd1a6-0e99-40e2-af2f-39e804fa7c74 24385-009 HUMAN OTC DRUG Good Neighbor Pharmacy ibuprofen childrens Ibuprofen SUSPENSION ORAL 19940809 ANDA ANDA074937 Amerisource Bergen IBUPROFEN 100 mg/5mL N 20181231 24385-011_f130ce02-1f83-4eec-9487-bbd2b8195740 24385-011 HUMAN OTC DRUG Good Neighbor pharmacy muscle rub Menthol, Methyl salicylate CREAM TOPICAL 20060117 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g N 20181231 24385-017_0d374fd6-23ac-43ce-82a2-2ad56ab8f392 24385-017 HUMAN OTC DRUG GNP Pink Bismuth Bismuth Subsalicylate TABLET ORAL 20110808 OTC MONOGRAPH FINAL part335 Amerisource Bergen BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 24385-021_a4313d5d-e549-49bf-b4d5-34b2a7d62c8b 24385-021 HUMAN OTC DRUG Good Neighbor Pharmacy Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen HYDROCORTISONE 1 g/100g N 20181231 24385-024_05923478-4d08-48da-9bcb-aae7f2fb5d58 24385-024 HUMAN OTC DRUG GNP Pink Bismuth Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20110707 OTC MONOGRAPH FINAL part335 Amerisource Bergen BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 24385-026_b0a9862d-b084-421e-9038-4a149ce14e30 24385-026 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus Relief DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 24385-028_b6b01b95-6003-4c9d-a7c0-01dc0fc6ad7c 24385-028 HUMAN OTC DRUG Good Neighbor Pharmacy Aspirin Aspirin TABLET, CHEWABLE ORAL 19930319 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ASPIRIN 81 mg/1 N 20181231 24385-032_bd8164cd-c58f-4f72-99a2-5fdb797521a7 24385-032 HUMAN OTC DRUG Tolnaftate Antifungal Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Amerisource Bergen TOLNAFTATE 10 mg/g N 20181231 24385-034_12062dbd-b4fd-4120-b981-8ba86230d82b 24385-034 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141028 OTC MONOGRAPH NOT FINAL part333A AmerisourceBergen ALCOHOL 700 mg/mL N 20181231 24385-036_2134bf70-d573-4060-96f8-b03b12a004ac 24385-036 HUMAN OTC DRUG good neighbor pharmacy day time cold and flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20120802 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 24385-038_5d7bb0a8-c201-55b7-e053-2a91aa0a9570 24385-038 HUMAN OTC DRUG GNP Glycerin and Arificial Rose Water Glycerin LIQUID TOPICAL 20171108 OTC MONOGRAPH FINAL part346 Amerisource Bergen GLYCERIN 100 mg/mL N 20181231 24385-053_49b195d0-00fe-4ea7-9483-0e71f8e9b8b4 24385-053 HUMAN OTC DRUG Povidone Iodine povidone-iodine SOLUTION TOPICAL 20050201 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen POVIDONE-IODINE .1 mg/mL E 20171231 24385-054_2cbf1e9f-f7f7-4bed-a4c6-6b0a7759a95e 24385-054 HUMAN OTC DRUG good neighbor pharmacy nasal decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19990812 ANDA ANDA075153 Amerisource Bergen PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 24385-058_2e29b4cb-ffab-436e-b3af-fc0ee7db8c52 24385-058 HUMAN OTC DRUG Good Neighbor Pharmacy ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060614 ANDA ANDA077349 Amerisource Bergen IBUPROFEN 200 mg/1 N 20181231 24385-060_27da22e1-d204-4a26-b449-873693070dcf 24385-060 HUMAN OTC DRUG Good Neighbor Pharmacy Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B AmerisourceBergen BACITRACIN ZINC 500 [iU]/g N 20181231 24385-065_06c72836-e1f8-4432-914b-7756e1858aeb 24385-065 HUMAN OTC DRUG Alcohol Pad isopropyl alcohol SWAB TOPICAL 19950801 OTC MONOGRAPH NOT FINAL part333E Amerisource Bergen ISOPROPYL ALCOHOL .7 mL/1 E 20171231 24385-066_34de34ae-1036-4652-bc3d-b922dc5a283e 24385-066 HUMAN OTC DRUG good neighbor pharmacy cold multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 19930330 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 24385-067_7c7375e2-9631-41b9-82c8-55dba544ce9d 24385-067 HUMAN OTC DRUG good neighbor pharmacy nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 19950504 OTC MONOGRAPH FINAL part341 Amerisource Bergen OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 24385-070_7b22d6ee-ff45-42b2-96c0-e86718595506 24385-070 HUMAN OTC DRUG Good Neighbor Pharmacy Vitamin A and D Lanolin, Petrolatum OINTMENT TOPICAL 20050823 OTC MONOGRAPH FINAL part347 Amerisource Bergen LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g N 20181231 24385-072_d89008cc-2242-436c-bb1c-865febae8091 24385-072 HUMAN OTC DRUG GNP Caldyphen Calamine and Pramoxine Hydrochloride LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 Amerisource Bergen ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 24385-075_03e15422-9b82-4a92-873c-0b50a906cd33 24385-075 HUMAN OTC DRUG Good Neighbor Pharmacy Eye Drop Tetrahydrozoline HCl 0.05% SOLUTION/ DROPS INTRAOCULAR 20010129 OTC MONOGRAPH FINAL part349 AmerisourceBergen Drug Corporation TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 24385-077_6afb78da-b815-4d49-ba54-082cf3093d34 24385-077 HUMAN OTC DRUG Good Neighbor Pharmacy Eye Drops Advanced Relief DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION/ DROPS INTRAOCULAR 20010129 OTC MONOGRAPH FINAL part349 AmerisourceBergen Drug Corporation DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .1; 1; 1; .05 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 24385-083_97a6327f-e5d9-4227-9f05-934b1f94d826 24385-083 HUMAN OTC DRUG Good Neighbor Pharmacy Aloe Vera Lidocaine Hydrochloride GEL TOPICAL 19881128 OTC MONOGRAPH NOT FINAL part348 Amerisourcebergen Drug Corporation LIDOCAINE HYDROCHLORIDE 500 g/100000mg N 20181231 24385-106_da92a7ff-e3a4-4f41-806b-e02e6ee11090 24385-106 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid Extra Strength Calcium Carbonate TABLET, CHEWABLE ORAL 20100712 OTC MONOGRAPH FINAL part331 AmerisourceBergen Drug Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 24385-110_0eced1bb-3ac5-4de8-b8b6-0b54a4154972 24385-110 HUMAN OTC DRUG Good Neighbor Pharmacy Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 AmerisourceBergen CLOTRIMAZOLE 2 g/100g N 20181231 24385-111_ba74fadd-acd1-432a-956a-0e906512e240 24385-111 HUMAN OTC DRUG Good Neighbor Pharmacy Heartburn Relief Cimetidine TABLET ORAL 20000105 ANDA ANDA075285 Amerisource Bergen CIMETIDINE 200 mg/1 N 20181231 24385-113_fea96792-4e7d-44ba-958c-f13411706a49 24385-113 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part356 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 24385-116_8105e191-1118-4d91-b168-fc42aaa9af47 24385-116 HUMAN OTC DRUG good neighbor pharmacy Lice Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070731 OTC MONOGRAPH FINAL part358G Amerisource Bergen PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL N 20181231 24385-118_ea386085-09bd-4340-8ec7-ce5e9a958dc4 24385-118 HUMAN OTC DRUG GNP Regular Strength Gas Relief DIMETHICONE TABLET, CHEWABLE ORAL 20110808 OTC MONOGRAPH FINAL part332 GNP Gas Relief DIMETHICONE 80 mg/1 N 20181231 24385-125_60eae3dd-db32-4505-ba4f-7132ba763f07 24385-125 HUMAN OTC DRUG Good Neighbor Pharmacy Fiber-Caps Fiber Laxative Stimulant Free Calcium Polycarbophil CAPSULE ORAL 20100713 OTC MONOGRAPH NOT FINAL part334 Amerisourcebergen Drug Corporation CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 24385-133_11dcfcb3-ae62-4fd7-a1c7-d211e8c6038c 24385-133 HUMAN OTC DRUG Soothing Bath Treatment Colloidal Oatmeal POWDER TOPICAL 19941001 OTC MONOGRAPH FINAL part347 Amerisource Bergen OATMEAL 1 g/g E 20171231 24385-135_79e5c7de-6967-41fd-84a2-d1897d436e00 24385-135 HUMAN OTC DRUG good neighbor pharmacy cough and sore throat Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060214 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 24385-141_09ff2eb2-7d4a-468c-8cb1-ffeff0754c97 24385-141 HUMAN OTC DRUG Good Neighbor Pharmacy Muscle Rub Ultra Strength Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20050802 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g N 20181231 24385-143_53270d3d-2d3d-4779-9dd5-54766406de05 24385-143 HUMAN OTC DRUG Good Neighbor Pharmacy Triple Antibiotic Plus Pain Relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Amerisource Bergen BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 24385-145_b4261dd0-6def-4288-a892-57b3012a23dd 24385-145 HUMAN OTC DRUG good neighbor pharmacy pain relief extra strength Acetaminophen TABLET, FILM COATED ORAL 20060105 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 500 mg/1 N 20181231 24385-161_ba155366-479c-4de8-b02f-cc287131a60d 24385-161 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Good Neighbor Pharmacy LORATADINE 10 mg/1 N 20181231 24385-165_ec1ca0fa-5325-41be-a4fb-101cef5abdb5 24385-165 HUMAN OTC DRUG good neighbor pharmacy arthritis pain Trolamine Salicylate CREAM TOPICAL 19900215 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen TROLAMINE SALICYLATE 10 g/100g N 20181231 24385-175_c2054637-65b4-4944-9fe8-253965c19b9a 24385-175 HUMAN OTC DRUG Good Neighbor Pharmacy All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080506 ANDA ANDA077170 Amerisource Bergen CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 24385-183_6cfba0e9-731b-4a34-b4ab-ee91ec6e9e20 24385-183 HUMAN OTC DRUG Good Neighbor Pharmacy Dayhist Allergy Clemastine fumarate TABLET ORAL 19960628 ANDA ANDA074512 Amerisource Bergen CLEMASTINE FUMARATE 1.34 mg/1 N 20181231 24385-190_1bcedd11-81cc-47ed-b23d-416c614b19be 24385-190 HUMAN OTC DRUG Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin Hydrocortisone CREAM TOPICAL 20010913 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen HYDROCORTISONE .5 g/100g N 20181231 24385-193_71b39099-f102-419f-84c1-8e2c6d6d43ae 24385-193 HUMAN OTC DRUG womens laxative Bisacodyl TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 BISACODYL 5 mg/1 N 20181231 24385-200_6d97c9b1-3107-4ef2-b738-1d4c6c21c63b 24385-200 HUMAN OTC DRUG Hygienic Cleansing Pads witch hazel SOLUTION RECTAL; TOPICAL 20030501 OTC MONOGRAPH FINAL part346 Amerisource Bergen WITCH HAZEL .5 mL/mL E 20171231 24385-201_fdf66de5-7d61-4908-ac96-7625c575dbe8 24385-201 HUMAN OTC DRUG good neighbor pharmacy complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080804 ANDA ANDA077355 Amerisource Bergen FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 24385-205_00b4c106-346c-48a1-a62e-19230c73d15e 24385-205 HUMAN OTC DRUG Good Neighbor Pharmacy Clotrimazole Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C AmerisourceBergen CLOTRIMAZOLE 10 mg/g N 20181231 24385-210_a077ddc0-abcb-45ef-8652-65429fda89a5 24385-210 HUMAN OTC DRUG Anti-Itch Diphenhydramine hydrochloride and Zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 24385-213_5e1c4e31-9c21-1113-e053-2a91aa0ae173 24385-213 HUMAN OTC DRUG GNP Idoinde Tincture 2% Mild Iodine and Sodium Iodide and Alcohol LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 24385-225_4b85c355-6532-434a-9598-b2f3403bb3cd 24385-225 HUMAN OTC DRUG Good Neighbor Pharmacy Therapeutic Blue Menthol GEL TOPICAL 19880311 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen Drug Corporation MENTHOL 2 g/100g N 20181231 24385-236_accec0c3-8407-470e-b6a6-8f7bf6d10883 24385-236 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid LIQUID TOPICAL 20120110 OTC MONOGRAPH FINAL part358B AmerisourceBergen Drug Corporation SALICYLIC ACID .17 mg/15mL N 20181231 24385-241_f059c4bc-113e-4eb7-8b7c-8114db95526d 24385-241 HUMAN OTC DRUG Good Neighbor Pharmacy Cold and Hot Therapy Pain Relief Balm Extra Strength MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20000524 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen Drug Corporation MENTHOL; METHYL SALICYLATE 7.6; 29 g/100g; g/100g N 20181231 24385-249_b0f51ce4-6ea6-48f4-b3e8-e2473877eb15 24385-249 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20141231 OTC MONOGRAPH NOT FINAL part333A AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 24385-262_8db8e524-7456-4822-8169-d74a4f3c743a 24385-262 HUMAN OTC DRUG Cough Relief Long Acting Dextromethorphan HBr LIQUID ORAL 20120312 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 24385-263_63e0b8ec-07fd-4ae2-a0a4-2af22f67cbb7 24385-263 HUMAN OTC DRUG Cough Relief Long Acting Dextromethorphan HBr LIQUID ORAL 20140805 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 24385-274_0e83d65a-46b5-44ae-8558-3392fe97a2c5 24385-274 HUMAN OTC DRUG Good Neighbor Pharmacy Hydrocortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen HYDROCORTISONE 1 g/100g N 20181231 24385-276_2e83c8a7-5e89-40d4-86d7-ca9ad23d7516 24385-276 HUMAN OTC DRUG Good Neighbor Pharmacy Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen HYDROCORTISONE 1 g/100g N 20181231 24385-278_a0828f44-e86a-4dc3-a7f4-e8d2e5a50d83 24385-278 HUMAN OTC DRUG good neighbor pharmacy aspirin Aspirin TABLET, CHEWABLE ORAL 19970626 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ASPIRIN 81 mg/1 N 20181231 24385-291_d6a19599-babf-4fe5-8857-157212949242 24385-291 HUMAN OTC DRUG good neighbor pharmacy anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19940401 UNAPPROVED DRUG OTHER Amerisource Bergen DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 24385-302_5b2cb541-3a26-450e-8776-8d74425166f3 24385-302 HUMAN OTC DRUG Stomach Relief Original Strength Bismuth subsalicylate LIQUID ORAL 20130506 OTC MONOGRAPH FINAL part335 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 24385-332_d6e1e68e-07f5-4820-8e3b-467c48967288 24385-332 HUMAN OTC DRUG good neighbor pharmacy milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19900415 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 24385-337_435c1669-2474-4fa6-8f97-7938c21af7bb 24385-337 HUMAN OTC DRUG Peptic Relief Maximum Strength Maximum Strength Pepto Bismol SUSPENSION ORAL 20120101 OTC MONOGRAPH FINAL part335 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 BISMUTH SUBSALICYLATE 525 mg/15mL N 20181231 24385-340_933dd446-73f6-47c6-be99-9130999393c2 24385-340 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 19900915 OTC MONOGRAPH FINAL part331 Amerisource Bergen ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 24385-352_385d8be6-0330-41db-8899-9162a5f1b7bb 24385-352 HUMAN OTC DRUG Good Neighbor Pharmacy Nasal Oxymetazoline HCl SPRAY NASAL 20020306 OTC MONOGRAPH FINAL part341 Amerisource Bergen OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 24385-356_1e9b7b3a-f41b-4223-83e9-88c0478aea67 24385-356 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20021105 OTC MONOGRAPH FINAL part332 Amerisource Bergen ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 24385-357_7837c1a4-cc63-48aa-9813-f6b51f1983e9 24385-357 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 19900615 20190401 OTC MONOGRAPH FINAL part332 Amerisource Bergen ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 24385-359_f2336b38-556c-479b-b3c1-ce0758279912 24385-359 HUMAN OTC DRUG Good Neighbor Pharmacy Tussin dm Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 19910827 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 24385-361_c96018d1-2ef9-47d8-9a82-6b2aef290d24 24385-361 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20020513 ANDA ANDA074937 Amerisource Bergen IBUPROFEN 100 mg/5mL N 20181231 24385-362_be852176-a6c6-4517-91d8-cbe649131f6e 24385-362 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20060823 20190204 OTC MONOGRAPH FINAL part332 Amerisource Bergen ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 24385-364_92594258-bf2a-4756-831e-7552104565a2 24385-364 HUMAN OTC DRUG Good Neighbor Pharmacy aspirin orange flavor chewable Aspirin TABLET, CHEWABLE ORAL 20020220 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ASPIRIN 81 mg/1 N 20181231 24385-365_e516fbef-2483-49b1-8e99-ce6792cb6690 24385-365 HUMAN OTC DRUG good neighbor pharmacy migraine relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20020513 ANDA ANDA075794 Amerisource Bergen ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 24385-369_fe74f894-5335-4e15-8e15-a4614dc99829 24385-369 HUMAN OTC DRUG Laxative pills maximum strength Sennosides TABLET ORAL 20100708 OTC MONOGRAPH NOT FINAL part334 Amerisourcebergen Drug Corporation (Good Neighbour Pharmacy) SENNOSIDES 25 mg/1 N 20181231 24385-370_6e8e4780-b80c-4e5d-8d30-038935f8719c 24385-370 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20141027 OTC MONOGRAPH NOT FINAL part333A Amerisource Begen ALCOHOL 70 mL/100mL N 20181231 24385-372_84dd6346-dbca-487f-88b3-69e701d884da 24385-372 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20020402 ANDA ANDA074937 Amerisource Bergen IBUPROFEN 100 mg/5mL N 20181231 24385-374_5b29d1e4-050f-464e-b95f-87be9d257c31 24385-374 HUMAN OTC DRUG Good Neighbor Pharmacy Tioconazole 1 Tioconazole OINTMENT VAGINAL 20080220 ANDA ANDA075915 Amerisource Bergen TIOCONAZOLE 6.5 g/100g N 20181231 24385-379_fc78542c-1bbb-4af9-8c32-1a2153b6371a 24385-379 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Allergy Diphenhydramine Hydrochloride SOLUTION ORAL 19890815 OTC MONOGRAPH FINAL part341 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 24385-385_ba302e10-a6e2-4a56-9a06-46198776606f 24385-385 HUMAN OTC DRUG Good Neighbor Pharmacy Acid Reducer Maximum Strength Famotidine TABLET ORAL 20061024 ANDA ANDA077351 Amerisource Bergen FAMOTIDINE 20 mg/1 N 20181231 24385-386_8753a5ef-f87b-438a-a3a4-53827e946476 24385-386 HUMAN OTC DRUG good neighbor pharmacy anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20080626 ANDA ANDA075232 Amerisource Bergen LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 24385-388_014f5869-660e-4d6c-8fc0-9f2f0e8b3088 24385-388 HUMAN OTC DRUG Motion sickness Relief Meclizine Hydrochloride TABLET ORAL 20100709 OTC MONOGRAPH FINAL part336 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 24385-390_51574cf1-e80e-4715-8ae5-d994dbd34108 24385-390 HUMAN OTC DRUG good neighbor pharmacy nose Phenylephrine hydrochloride SOLUTION/ DROPS NASAL 19940401 OTC MONOGRAPH FINAL part341 Amerisource Bergen PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 24385-396_5a488885-7913-4b8e-8a44-d2ffea9ad337 24385-396 HUMAN OTC DRUG Good Neighbor Pharmacy milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19900215 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 24385-404_9089757d-2174-4deb-8d40-cd36418ac9b9 24385-404 HUMAN OTC DRUG Good Neighbor Senna Sennosides TABLET ORAL 20121102 OTC MONOGRAPH FINAL part334 AmerisourceBergen SENNOSIDES A AND B 8.6 mg/1 N 20181231 24385-407_5e1b2969-c190-9f73-e053-2991aa0a0c6e 24385-407 HUMAN OTC DRUG Calamine Phenolated Topical Suspension Calamine and Zinc Oxide and Phenol LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 Amerisource Bergen ZINC OXIDE; PHENOL 160; 10 mg/mL; mg/mL N 20181231 24385-413_5e1bbad0-3938-07b3-e053-2991aa0a6009 24385-413 HUMAN OTC DRUG GNP Calamine Topical Suspension Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 Amerisource Bergen ZINC OXIDE 160 mg/mL N 20181231 24385-416_91412263-9c8f-4705-9398-fd503026df21 24385-416 HUMAN OTC DRUG Good Neighbor Pharmacy Aspirin Aspirin TABLET ORAL 19890915 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ASPIRIN 325 mg/1 N 20181231 24385-421_ba83b1fe-23a3-4673-8b31-e47d02cf1cd7 24385-421 HUMAN OTC DRUG Hemorrhoidal Cooling Gel phenylephrine and witch hazel GEL TOPICAL 20060801 OTC MONOGRAPH FINAL part346 Amerisource Bergen PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/g; g/g E 20171231 24385-428_5cfdb985-3fd1-4265-9676-d3612904a75f 24385-428 HUMAN OTC DRUG Good Neighbor Pharmacy Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 19990812 OTC MONOGRAPH FINAL part332 Amerisource Bergen DIMETHICONE 125 mg/1 N 20181231 24385-429_1957f9d8-2d1f-492c-8f6a-db312aba722b 24385-429 HUMAN OTC DRUG Aspirin regular strength Aspirin TABLET, COATED ORAL 20111117 OTC MONOGRAPH FINAL part343 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 ASPIRIN 325 mg/1 N 20181231 24385-431_6e56a62f-67b5-46f6-a3b0-2878481f1be2 24385-431 HUMAN OTC DRUG Good Neighbor Pharmacy Sleep Aid Diphenhydramine Hydrochloride TABLET ORAL 20010414 OTC MONOGRAPH FINAL part338 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 24385-432_c4f31d50-1256-45ef-bfa9-7440435af21a 24385-432 HUMAN OTC DRUG Good Neighbor Pharmacy Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19890815 OTC MONOGRAPH FINAL part341 Amerisource Bergen PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 24385-435_cc99f774-f1e4-4424-abef-809c4564d49f 24385-435 HUMAN OTC DRUG Docusate Calcium stool softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20100712 20191230 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 DOCUSATE CALCIUM 240 mg/1 E 20171231 24385-439_2fbbb4fa-1f07-4adb-b2ba-50a15dd2dec9 24385-439 HUMAN OTC DRUG Caldyphen Clear Pramoxine Hydrochloride and Zinc acetate LOTION TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 24385-441_0c4f7232-4889-4cca-a807-c6d6aaa183e6 24385-441 HUMAN OTC DRUG Good Neighbor Pharmacy Sleep Aid Doxylamine succinate TABLET ORAL 19970626 ANDA ANDA040167 Amerisource Bergen DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 24385-443_52b9a885-edb8-48d4-b130-2b4906a70d12 24385-443 HUMAN OTC DRUG STOOL SOFTENER EXTRA STRENGTH DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100709 20181212 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 DOCUSATE SODIUM 250 mg/1 E 20171231 24385-460_6c3f79ee-9a5a-495a-8757-5b18087e9af6 24385-460 HUMAN OTC DRUG AntiGas ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20100708 OTC MONOGRAPH FINAL part332 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 DIMETHICONE 180 mg/1 N 20181231 24385-461_a9442aee-22d5-4803-a4af-6131a46623ae 24385-461 HUMAN OTC DRUG Good Neighbor Pharmacy night time cough Dextromethorphan Hydrobromide, Doxylamine Succinate SOLUTION ORAL 20030630 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 24385-462_219557a8-2b60-4aea-a56f-b0233db99c4b 24385-462 HUMAN OTC DRUG good neighbor pharmacy allergy diphenhydramine hydrochloride CAPSULE ORAL 19891015 OTC MONOGRAPH FINAL part341 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 24385-463_5db02976-9fac-4a0b-ad40-23a539b958b2 24385-463 HUMAN OTC DRUG Good Neighbor Pharmacy Allergy Chlorpheniramine Maleate TABLET ORAL 19890715 OTC MONOGRAPH FINAL part341 Amerisource Bergen CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 24385-466_61c0e797-cc6e-414d-9205-1eb941118b4d 24385-466 HUMAN OTC DRUG GNP Fiber Therapy Methylcellulose TABLET ORAL 20110909 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen METHYLCELLULOSE (4000 CPS) 500 mg/1 N 20181231 24385-471_46820cf9-920a-4473-954b-5e531e00e91b 24385-471 HUMAN OTC DRUG good neighbor pharmacy loratadine Loratadine TABLET ORAL 20081110 ANDA ANDA076301 Amerisource Bergen LORATADINE 10 mg/1 N 20181231 24385-479_89d9a16a-506f-47da-85f8-b3594a8d3809 24385-479 HUMAN OTC DRUG Good Neighbor Pharmacy allergy Diphenhydramine Hydrochloride TABLET ORAL 19910830 OTC MONOGRAPH FINAL part341 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 24385-484_190814b0-8374-4e81-9d4f-6f4f49da3586 24385-484 HUMAN OTC DRUG Good Neighbor Pharmacy Pain Relief Acetaminophen TABLET ORAL 19891215 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 500 mg/1 N 20181231 24385-485_3d407573-4e87-427a-a1ff-37caa2e72003 24385-485 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid Regular Strength Calcium Carbonate TABLET, CHEWABLE ORAL 20100713 OTC MONOGRAPH FINAL part331 AmerisourceBergen Drug Corporation CALCIUM CARBONATE 500 mg/1 N 20181231 24385-490_0435215a-139d-4af6-8a6e-753886a82169 24385-490 HUMAN OTC DRUG Good Neighbor Pharmacy naproxen sodium Naproxen Sodium TABLET ORAL 19980312 ANDA ANDA074661 Amerisource Bergen NAPROXEN SODIUM 220 mg/1 N 20181231 24385-493_2f97b007-e5ff-479e-bb80-7b47b5aa52f9 24385-493 HUMAN OTC DRUG Good Neighbor Pharmacy Tussin Dextromethorphan Hydrobromide LIQUID ORAL 19920210 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL N 20181231 24385-495_4823a265-7cf4-4491-b40d-1928fc846b7a 24385-495 HUMAN OTC DRUG Docusate sodium and Sennosides Docusate sodium and Sennosides TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 24385-499_f0ec8821-2580-4bc9-9cc8-8f692214f594 24385-499 HUMAN OTC DRUG Ibuprofen softgels Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100708 ANDA ANDA078682 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 IBUPROFEN 200 mg/1 N 20181231 24385-501_664ed3d6-89c2-4336-a34f-d9553ab35cc9 24385-501 HUMAN OTC DRUG Ear System GNP Carbamide Peroxide 6.50% KIT 20031015 OTC MONOGRAPH FINAL part344 Amerisource Bergen N 20181231 24385-503_232937b5-93d7-4d74-b15e-23fdb2a39590 24385-503 HUMAN OTC DRUG Good Neighbor Pharmacy Ear System Carbamide Peroxide SOLUTION/ DROPS TOPICAL 20030415 OTC MONOGRAPH FINAL part344 AmerisourceBergen Drug Corporation CARBAMIDE PEROXIDE 6.5 g/100mL N 20181231 24385-505_447879b9-e0fe-4f63-9765-c8e03b5c13da 24385-505 HUMAN OTC DRUG Senna Plus docusate sodium and sennosides TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 Amerisourcebergen Drug Corporation (Good Neighbour Pharmacy) SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 24385-515_5d06bec6-f1e8-4f0c-e053-2991aa0a8ad8 24385-515 HUMAN OTC DRUG GNP Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen CASTOR OIL 1 mg/mL N 20181231 24385-517_0bd59ad1-cac5-46a5-b612-5db9353cbe86 24385-517 HUMAN OTC DRUG good neighbor pharmacy cold and allergy childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20060919 OTC MONOGRAPH FINAL part341 Amerisource Bergen PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 24385-519_b065bd11-bf16-40e3-b750-ae2cfb2001b2 24385-519 HUMAN OTC DRUG good neighbor pharmacy cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20060911 OTC MONOGRAPH FINAL part341 Amerisource Bergen BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 24385-524_60c3c3ef-8f8c-4650-9c71-c4bb8e7d74be 24385-524 HUMAN OTC DRUG Good Neighbor Pharmacy Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 AmerisourceBergen TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 24385-531_c173efeb-b7ef-4846-b161-7aad21f3a984 24385-531 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 AmerisourceBergen LORATADINE 5 mg/5mL N 20181231 24385-540_ba155366-479c-4de8-b02f-cc287131a60d 24385-540 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Good Neighbor Pharmacy LORATADINE 10 mg/1 N 20181231 24385-543_f87a080d-e3aa-4698-8c65-915d8ea77da2 24385-543 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 AmerisourceBergen LORATADINE 5 mg/5mL N 20181231 24385-546_c02a347d-df05-4191-b506-1b2ad754a014 24385-546 HUMAN OTC DRUG good neighbor pharmacy ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20041012 ANDA ANDA076359 Amerisource Bergen IBUPROFEN 100 mg/1 N 20181231 24385-550_590f8dc7-19ab-4645-bb3c-fb26242c52b0 24385-550 HUMAN OTC DRUG good neighbor pharmacy ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20041012 ANDA ANDA075217 Amerisource Bergen IBUPROFEN 50 mg/1.25mL N 20181231 24385-554_df611849-3009-4352-b630-b322e6e900a8 24385-554 HUMAN OTC DRUG good neighbor pharmacy anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030512 ANDA ANDA075232 Amerisource Bergen LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 24385-578_5731ce7f-4890-4e16-9ffd-6e1bf1685253 24385-578 HUMAN OTC DRUG good neighbor pharmacy tussin dm Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19940919 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 24385-590_8759e7b4-9386-48ed-a027-2e5205767db4 24385-590 HUMAN OTC DRUG Good Neighbor Pharmacy Miconazole 7 Miconazole nitrate CREAM VAGINAL 19991011 ANDA ANDA074760 Amerisource Bergen MICONAZOLE NITRATE 2 g/100g N 20181231 24385-594_4ce88585-c225-42a6-9119-59554549e8de 24385-594 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050831 ANDA ANDA078325 Amerisource Bergen NICOTINE 2 mg/1 N 20181231 24385-598_a9992ee8-f8ae-4416-a960-8d9e70024545 24385-598 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050831 ANDA ANDA078326 Amerisource Bergen NICOTINE 4 mg/1 N 20181231 24385-601_0c74431f-129a-42f5-bdb1-57c327f59b68 24385-601 HUMAN OTC DRUG Good Neighbor Pharmacy Stay Awake Caffeine TABLET ORAL 20010716 OTC MONOGRAPH FINAL part340 Amerisource Bergen CAFFEINE 200 mg/1 N 20181231 24385-602_85ae77c0-f496-4839-8bf7-eb0e0e200979 24385-602 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus Relief Guaifenesin TABLET ORAL 20110915 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corp GUAIFENESIN 400 mg/1 N 20181231 24385-603_a655972d-299a-4a51-979d-48e27d380706 24385-603 HUMAN OTC DRUG good neighbor pharmacy nasal decongestant pe non drowsy Phenylephrine Hydrochloride TABLET ORAL 20050628 OTC MONOGRAPH FINAL part341 Amerisource Bergen PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 24385-604_2853362f-f7da-44f4-84db-5d8017c7df6b 24385-604 HUMAN OTC DRUG good neighbor pharmacy ibuprofen Ibuprofen TABLET ORAL 19900115 ANDA ANDA072096 Amerisource Bergen IBUPROFEN 200 mg/1 N 20181231 24385-606_a709333c-92fd-4015-a15e-cbe19941bfb9 24385-606 HUMAN OTC DRUG Good Neighbor Pharmacy Miconazole Nitrate Miconazole nitrate KIT 20000502 ANDA ANDA075329 Amerisource Bergen N 20181231 24385-608_7aad4cc1-df0e-4bc9-878f-94b681533530 24385-608 HUMAN OTC DRUG good neighbor pharmacy milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20050412 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 24385-619_20a33d42-f9d5-45ee-8212-b2d11d3c39a0 24385-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20100712 OTC MONOGRAPH FINAL part347 Amerisource Bergen DIMETHICONE 13.13 mg/mL N 20181231 24385-629_3d191143-cf7c-4c29-8090-f13072411e09 24385-629 HUMAN OTC DRUG good neighbor pharmacy pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081103 ANDA ANDA075077 Amerisource Bergen ACETAMINOPHEN 650 mg/1 N 20181231 24385-634_8e1085cc-f9d9-4961-b2b1-ef9619ec227a 24385-634 HUMAN OTC DRUG good neighbor pharmacy lice piperonyl butoxide, pyrethrum extract KIT 19940401 OTC MONOGRAPH FINAL part358G Amerisource Bergen N 20181231 24385-647_d1942bb6-9102-4406-a349-953c44d72b27 24385-647 HUMAN OTC DRUG good neighbor pharmacy ibuprofen Ibuprofen TABLET, COATED ORAL 19890915 ANDA ANDA072096 Amerisource Bergen IBUPROFEN 200 mg/1 N 20181231 24385-675_a6842e7c-0369-48fc-b494-3d7330e2e329 24385-675 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150531 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 24385-676_2fcbd99a-70b9-4e41-b469-defc2aaa0e47 24385-676 HUMAN OTC DRUG Good Neighbor Anti-Fungal Undecylenic acid LIQUID TOPICAL 20080801 OTC MONOGRAPH FINAL part333C AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) UNDECYLENIC ACID 250 mg/mL N 20181231 24385-678_a6fc5806-94e1-41a5-9124-65dfe3400c6f 24385-678 HUMAN OTC DRUG Good Neighbor Pharmacy Scalp Relief Salicylic Acid LIQUID TOPICAL 19980202 OTC MONOGRAPH FINAL part358H AmerisourceBergen Drug Corportaion SALICYLIC ACID 3 g/100g N 20181231 24385-803_11d662f9-9fe2-4ddf-9387-81c180345ceb 24385-803 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY FIRST AID Contains 202 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN, BENZOCAINE, ALCOHOL KIT 20100502 OTC MONOGRAPH FINAL part333 AmerisourceBergen N 20181231 24385-804_31fe4b5d-bdbe-4366-b4b6-85fb0b4dba30 24385-804 HUMAN OTC DRUG Good Neighbor Pharmacy Emergency Preparedness and First Aid Contains 167 Pieces BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ASPIRIN, ETHYL ALCOHOL KIT 20100524 OTC MONOGRAPH FINAL part354 AmerisourceBergen N 20181231 24385-903_7a5fa1aa-1a9c-445b-b98e-7faf4eae2931 24385-903 HUMAN OTC DRUG Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20111024 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 BISACODYL 5 mg/1 N 20181231 24385-904_27794d0d-2d92-4fed-87fc-a735f0d1a865 24385-904 HUMAN OTC DRUG Good Neighbor Pharmacy Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060327 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 24385-905_a6babfc3-884b-461c-9f4b-341076b46d2e 24385-905 HUMAN OTC DRUG good neighbor pharmacy ibuprofen Ibuprofen SUSPENSION ORAL 19990128 ANDA ANDA074937 Amerisource Bergen IBUPROFEN 100 mg/5mL N 20181231 24385-910_3897d807-3bbb-496a-8bc2-7e220cedb63d 24385-910 HUMAN OTC DRUG Magnesium Citrate Oral Cherry Flavor Magnesium Citrate LIQUID ORAL 20120101 20180401 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 MAGNESIUM CITRATE 2.65 g/100mL N 20181231 24385-925_19f17707-05ae-42cf-9b2b-f758ff44a62b 24385-925 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus Relief PE PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corp GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 24385-937_6696c885-40c2-459d-9383-9881f04905e7 24385-937 HUMAN OTC DRUG Good Neighbor Pharmacy Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, FILM COATED ORAL 20090223 ANDA ANDA079113 Amerisource Bergen DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20191231 24385-955_e9d8b71c-e35f-44fa-9542-d4d2278c9a7f 24385-955 HUMAN OTC DRUG Ear Drops Earwax Removal Aid Carbamide Peroxide LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part344 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) CARBAMIDE PEROXIDE 65 mg/mL E 20171231 24385-958_5996132f-13c9-49a3-ab9e-751db97484ba 24385-958 HUMAN OTC DRUG good neighbor pharmacy cold remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20080805 UNAPPROVED HOMEOPATHIC Amerisource Bergen ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 24385-980_1652f850-ffd6-46b9-8b37-4d5c0bbbfc81 24385-980 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen BENZALKONIUM CHLORIDE .13 mL/mL E 20171231 24385-981_45801872-4aca-46ef-8f1e-ff34d944552e 24385-981 HUMAN OTC DRUG Triacting Daytime Cold Cough Childrens Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20130506 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 24385-982_ae267fb9-5f23-4f9e-8138-b17d1e37d606 24385-982 HUMAN OTC DRUG Pain Relief Alcohol Swabs benzocaine SWAB TOPICAL 20070501 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 E 20171231 24385-985_38b3d777-2e3c-4946-b5a1-3405390ce7cd 24385-985 HUMAN OTC DRUG Childrens Mucus Relief cough Dextromethorphan HBr, Guaifensin LIQUID ORAL 20120229 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 24385-998_88ff399f-32ad-4260-8207-633c07bf28d6 24385-998 HUMAN OTC DRUG good neighbor pharmacy all day allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20080115 ANDA ANDA078336 Amerisource Bergen CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 24417-001_977772f9-0f6a-46bc-8c49-9c961ab4909d 24417-001 HUMAN PRESCRIPTION DRUG FLUDEOXYGLUCOSE F 18 FLUDEOXYGLUCOSE F-18 INJECTION INTRAVENOUS 20111212 ANDA ANDA203990 UIHC-P E T IMAGING CENTER FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24438-001_fab49a9f-9c0f-4a00-81cf-c9bbd5ef0826 24438-001 HUMAN OTC DRUG Phoenix Balm Pain Relief Rub OINTMENT TOPICAL 20111201 OTC MONOGRAPH FINAL part348 Amazonian Naturals, Inc. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 50; 50; 50 mg/g; mg/g; mg/g E 20171231 24439-321_4f92100f-6738-4fe2-9360-4b5b7e5e6900 24439-321 HUMAN OTC DRUG TopSani Benzalkonium Chloride LIQUID TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part333E United Promotions Inc. BENZALKONIUM CHLORIDE 1.25 mL/1000mL N 20181231 24445-334_c58bb937-3c1c-4651-aac3-18b03439a7c8 24445-334 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20150107 ANDA ANDA204512 NCM-USA Bronx LLC FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24445-623_2a9a67e8-bf1f-4da9-b498-de7ff49c3634 24445-623 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F 18 INJECTION INTRAVENOUS 20141028 ANDA ANDA204513 NCM USA Bronx LLC SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24445-643_de935eec-8632-463a-9229-aabb1f9b89c0 24445-643 HUMAN PRESCRIPTION DRUG Ammonia N 13 N 13 AMMONIA N-13 INJECTION INTRAVENOUS 20150204 ANDA ANDA204515 NCM USA Bronx LLC AMMONIA N-13 260 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24450-113_6fd639ce-dde7-475c-a63b-d5bf3f111a05 24450-113 HUMAN PRESCRIPTION DRUG AMMONIA N-13 AMMONIA N-13 INJECTION INTRAVENOUS 20141030 NDA NDA203783 Brigham and Women's Hospital, Inc., The AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24450-647_9f114496-e309-40c6-b09f-56509525b4bb 24450-647 HUMAN PRESCRIPTION DRUG FLUDEOXYGLUCOSE F-18 FLUDEOXYGLUCOSE F-18 INJECTION INTRAVENOUS 20141030 ANDA ANDA203816 BRIGHAM AND WOMEN`S HOSPITAL, INC., THE FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24451-001_5bc16ba0-117f-4f72-bd0f-43eb5ac3d7f0 24451-001 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20130624 ANDA ANDA077789 LLC Federal Solutions CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] E 20171231 24451-002_38d13c4f-3921-4676-827d-146202172021 24451-002 HUMAN OTC DRUG FERROUS SULFATE FERROUS SULFATE ELIXIR ORAL 20130812 UNAPPROVED DRUG OTHER LLC Federal Solutions FERROUS SULFATE 220 mg/5mL E 20171231 24451-008_46557d9b-ba31-4f41-9012-0f8452a58bfc 24451-008 HUMAN OTC DRUG Multi-Vitamin vitamin A, vitamin C, vitamin D, Vitamin E, thiamine, riboflavin, niacin, pyridoxine, and cyanocobalamin LIQUID ORAL 20130812 UNAPPROVED DRUG OTHER LLC Federal Solutions VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; CYANOCOBALAMIN 2250; 54; 360; 13.5; .842; 1.08; 12.2; .945; .00405 [iU]/5mL; mg/5mL; [iU]/5mL; [iU]/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL E 20171231 24451-091_18de8a4b-df09-498a-ab6b-df914a59e48a 24451-091 HUMAN OTC DRUG Aluminum Hydroxide Aluminum Hydroxide GEL ORAL 20130812 OTC MONOGRAPH FINAL part331 LLC Federal Solutions ALUMINUM HYDROXIDE 320 mg/5mL E 20171231 24451-133_119a9192-39fa-47d6-b277-eb0ff6ce87db 24451-133 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 20130808 OTC MONOGRAPH FINAL part341 LLC Federal Solutions GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL E 20171231 24451-289_15ecc7ae-011e-421f-b315-c6dee70bda0f 24451-289 HUMAN OTC DRUG Senna SENNOSIDES A AND B SYRUP ORAL 20130812 OTC MONOGRAPH NOT FINAL part334 LLC Federal Solutions SENNOSIDES A AND B 8.8 mg/5mL E 20171231 24451-548_1479dec5-5734-433b-898b-83d655c8a345 24451-548 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20130924 ANDA ANDA090263 LLC Federal Solutions LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 24451-725_182d5565-8aa9-493e-a24e-712433bc9302 24451-725 HUMAN OTC DRUG aluminum hydroxide, magnesium hydroxide, simethicone aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20130812 OTC MONOGRAPH FINAL part331 LLC Federal Solutions ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL E 20171231 24451-771_16a7177b-b651-4120-97f1-270295bcfa22 24451-771 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM LIQUID ORAL 20130808 OTC MONOGRAPH NOT FINAL part334 LLC Federal Solutions DOCUSATE SODIUM 50 mg/5mL E 20171231 24451-775_277d0918-d9b2-4ef7-910f-8f700dac851c 24451-775 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL 20130624 ANDA ANDA040014 LLC Federal Solutions LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 24451-788_170fb7bb-356e-41e6-8d35-4515b130cefd 24451-788 HUMAN OTC DRUG Milk of Magnesia MAGNESIUM HYDROXIDE SUSPENSION ORAL 20130812 OTC MONOGRAPH NOT FINAL part334 LLC Federal Solutions MAGNESIUM HYDROXIDE 2400 mg/30mL E 20171231 24453-198_378fcacb-4047-42e7-ab90-7684b345c2dc 24453-198 HUMAN OTC DRUG Flawless Tinted Moisturizer Light SPF 18 Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Anastasia Beverly Hills OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100g; g/100g; g/100g N 20181231 24453-199_e65f0e01-e6d3-446b-8289-19ee8b5504c7 24453-199 HUMAN OTC DRUG Flawless Tinted Moisturizer Medium SPF 18 Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Anastasia Beverly Hills OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100g; g/100g; g/100g N 20181231 24453-200_91ad8208-5910-425a-a994-24b565daf86d 24453-200 HUMAN OTC DRUG Flawless Tinted Moisturizer Dark SPF 18 Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Anastasia Beverly Hills OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100g; g/100g; g/100g N 20181231 24462-200_cc11fdde-5e58-488f-b736-176988e1f745 24462-200 HUMAN OTC DRUG MMA Elite Pain Relief menthol, camphor GEL TOPICAL 20111110 OTC MONOGRAPH NOT FINAL part348 MMA Pain Relief Gel, LLC MENTHOL; CAMPHOR (NATURAL) 5; 5 g/100g; g/100g E 20171231 24463-000_0875c779-9e78-415a-ad52-49894e96173c 24463-000 HUMAN OTC DRUG Brighter By Nature SPF 30 octinoxate, titanium dioxide, octocrylene POWDER TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 JO Cosmetics Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; OCTOCRYLENE .075; .03; .01 g/g; g/g; g/g N 20181231 24463-013_290b15e5-ef15-4153-9e3b-e6c45f240928 24463-013 HUMAN OTC DRUG Laura Mercier Flawless Skin Repair Oil Free Day Broad Spectrum SPF 15 Sunscreen Octinoxate LOTION TOPICAL 20090528 OTC MONOGRAPH NOT FINAL part352 JO Cosmetics Co., Ltd. OCTINOXATE 3.5 g/100mL N 20181231 24463-014_18e23e1c-641c-4bac-a6b0-5528c4d2e37e 24463-014 HUMAN OTC DRUG Laura Mercier Flawless Skin Repair Day Broad Spectrum SPF 15 Sunscreen Octinoxate CREAM TOPICAL 20090528 OTC MONOGRAPH NOT FINAL part352 JO Cosmetics Co., Ltd. OCTINOXATE 3.5 g/100g N 20181231 24463-015_c4d2a525-dbdd-4528-a412-1d358e1d6adc 24463-015 HUMAN OTC DRUG Laura Mercier Flawless Skin Repair Oil Free Day Broad Spectrum SPF 15 Sunscreen Octinoxate, Avobenzone, Oxybenzone LOTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 JO Cosmetics Co., Ltd. OCTINOXATE; AVOBENZONE; OXYBENZONE 3.5; .8; .5 g/100mL; g/100mL; g/100mL N 20181231 24463-016_7c4f729f-98e7-482f-b9df-db130bf56cd5 24463-016 HUMAN OTC DRUG Laura Mercier Flawless Skin Repair Day Broad Spectrum SPF 15 Sunscreen octinoxate, avobenzone, oxybenzone CREAM TOPICAL 20161025 OTC MONOGRAPH NOT FINAL part352 JO Cosmetics Co., Ltd. OCTINOXATE; AVOBENZONE; OXYBENZONE 3.5; .8; .5 g/100g; g/100g; g/100g N 20181231 24468-001_0eb82924-1ce5-680e-e054-00144ff88e88 24468-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F-18 Fludeoxyglucose F-18 Injection INJECTION INTRAVENOUS 20090914 ANDA ANDA203994 University of North Dakota FLUDEOXYGLUCOSE F-18 500 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 24470-900_60b9304f-e3e5-57b4-e053-2991aa0a5b0a 24470-900 HUMAN OTC DRUG BP Wash BENZOYL PEROXIDE EMULSION TOPICAL 20111215 OTC MONOGRAPH FINAL part333D CINTEX SERVICES, LLC BENZOYL PEROXIDE 50 mg/g N 20181231 24470-901_60b9b6c1-ce75-650a-e053-2a91aa0a97d0 24470-901 HUMAN OTC DRUG BP Wash BENZOYL PEROXIDE EMULSION TOPICAL 20120115 OTC MONOGRAPH FINAL part333D CINTEX SERVICES, LLC BENZOYL PEROXIDE 100 mg/g N 20181231 24470-902_5aae5296-49dd-4c43-8216-cfe9dffb1c6a 24470-902 HUMAN OTC DRUG BP Wash BENZOYL PEROXIDE EMULSION TOPICAL 20110115 OTC MONOGRAPH FINAL part333D CINTEX SERVICES, LLC BENZOYL PEROXIDE 70 mg/mL N 20181231 24470-909_2493f01b-183e-4e64-bf3d-487ff2622e5b 24470-909 HUMAN OTC DRUG BENZOYL PEROXIDE BENZOYL PEROXIDE GEL TOPICAL 20120628 OTC MONOGRAPH FINAL part333D Cintex Services, LLC BENZOYL PEROXIDE 50 mg/g N 20181231 24470-910_7f533b59-f276-4437-bb2c-a5a158ba0602 24470-910 HUMAN OTC DRUG BENZOYL PEROXIDE BENZOYL PEROXIDE GEL TOPICAL 20120628 OTC MONOGRAPH FINAL part333D Cintex Services, LLC BENZOYL PEROXIDE 100 mg/g N 20181231 24470-911_cbafdbc7-aa07-44aa-9584-3bf5ad88e153 24470-911 HUMAN OTC DRUG BP Wash BENZOYL PEROXIDE EMULSION TOPICAL 20110815 OTC MONOGRAPH FINAL part333D CINTEX SERVICES, LLC BENZOYL PEROXIDE 25 mg/g N 20181231 24470-912_a99b625d-0fce-4ea3-a9e0-b482bdc6789c 24470-912 HUMAN OTC DRUG Benzoyl Peroxide BENZOYL PEROXIDE AEROSOL, FOAM TOPICAL 20110304 OTC MONOGRAPH FINAL part333D Cintex Services, LLC BENZOYL PEROXIDE 53 mg/g N 20181231 24470-913_0262b130-fa02-403f-ba28-1625ee8d0e75 24470-913 HUMAN OTC DRUG Benzoyl Peroxide BENZOYL PEROXIDE AEROSOL, FOAM TOPICAL 20110304 OTC MONOGRAPH FINAL part333D Cintex Services, LLC BENZOYL PEROXIDE 98 mg/g N 20181231 24470-917_60a18f6b-5d85-29af-e053-2a91aa0ab282 24470-917 HUMAN PRESCRIPTION DRUG ergotamine tartrate and caffeine ergotamine tartrate and caffeine TABLET, FILM COATED ORAL 20161123 ANDA ANDA040590 Cintex Services, LLC ERGOTAMINE TARTRATE; CAFFEINE 1; 100 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 24470-919_63b010b7-a06e-7b0c-e053-2991aa0a04d4 24470-919 HUMAN PRESCRIPTION DRUG Flurandrenolide Cream FLURANDRENOLIDE CREAM TOPICAL 20160418 ANDA ANDA205342 Cintex Services, LLC FLURANDRENOLIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 24470-921_44be0ad9-6b18-2f2e-e054-00144ff88e88 24470-921 HUMAN PRESCRIPTION DRUG Flurandrenolide FLURANDRENOLIDE LOTION TOPICAL 20161222 ANDA ANDA205343 Cintex Services, LLC FLURANDRENOLIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 24471-200_f2d0e844-f3b5-8649-234b-26ca6cb97364 24471-200 HUMAN OTC DRUG Diabecline Tetracycline hydrochloride OINTMENT TOPICAL 20130523 OTC MONOGRAPH FINAL part333B THRU PHARMA, LLC TETRACYCLINE HYDROCHLORIDE 30 mg/mL E 20171231 24474-001_c819ce36-7ffc-4b9f-b359-e90d334a3a5f 24474-001 HUMAN OTC DRUG Run Guard Original ALLANTOIN STICK TOPICAL 20120401 OTC MONOGRAPH FINAL part347 RunGuards LLC ALLANTOIN .5 g/100g E 20171231 24474-002_f4edbc25-fcc0-45cb-a22a-4d2962e49542 24474-002 HUMAN OTC DRUG Run Guard Sensitive ALLANTOIN STICK TOPICAL 20120401 OTC MONOGRAPH FINAL part347 RunGuards LLC ALLANTOIN .5 g/100g E 20171231 24477-030_2d1575a0-f64d-11df-96e3-0002a5d5c51b 24477-030 HUMAN PRESCRIPTION DRUG Cardene I.V. nicardipine hydrochloride INJECTION INTRAVENOUS 19920130 NDA NDA019734 EKR Therapeutics NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 24478-120_4d4df73d-b07e-43e1-ba36-87257435b9b0 24478-120 HUMAN PRESCRIPTION DRUG QuilliChew ER methylphenidate hydrochloride TABLET, CHEWABLE, EXTENDED RELEASE ORAL 20160418 NDA NDA207960 NextWave Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 24478-130_4d4df73d-b07e-43e1-ba36-87257435b9b0 24478-130 HUMAN PRESCRIPTION DRUG QuilliChew ER methylphenidate hydrochloride TABLET, CHEWABLE, EXTENDED RELEASE ORAL 20160418 NDA NDA207960 NextWave Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 24478-140_4d4df73d-b07e-43e1-ba36-87257435b9b0 24478-140 HUMAN PRESCRIPTION DRUG QuilliChew ER methylphenidate hydrochloride TABLET, CHEWABLE, EXTENDED RELEASE ORAL 20160418 NDA NDA207960 NextWave Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 24478-190_e17c98ff-1587-4354-bc86-4a7f90425900 24478-190 HUMAN PRESCRIPTION DRUG Quillivant XR methylphenidate hydrochloride SUSPENSION, EXTENDED RELEASE ORAL 20121001 NDA NDA202100 NextWave Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 300 mg/60mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24478-200_e17c98ff-1587-4354-bc86-4a7f90425900 24478-200 HUMAN PRESCRIPTION DRUG Quillivant XR methylphenidate hydrochloride SUSPENSION, EXTENDED RELEASE ORAL 20121001 NDA NDA202100 NextWave Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 600 mg/120mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24478-205_e17c98ff-1587-4354-bc86-4a7f90425900 24478-205 HUMAN PRESCRIPTION DRUG Quillivant XR methylphenidate hydrochloride SUSPENSION, EXTENDED RELEASE ORAL 20130104 NDA NDA202100 NextWave Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 750 mg/150mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24478-210_e17c98ff-1587-4354-bc86-4a7f90425900 24478-210 HUMAN PRESCRIPTION DRUG Quillivant XR methylphenidate hydrochloride SUSPENSION, EXTENDED RELEASE ORAL 20121001 NDA NDA202100 NextWave Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 900 mg/180mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 24488-001_198d5e56-8559-42c1-a5be-35094578ae7d 24488-001 HUMAN OTC DRUG Pain Relieving Ultra Strength Camphor Menthol Methyl Salicylate CREAM TOPICAL 20100331 UNAPPROVED DRUG OTHER Creation's Garden Natural Products, Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 2.28; 5.7; 9 g/57g; g/57g; g/57g E 20171231 24488-001_9eeb2e24-edb9-446f-93d6-aa1613ccd39a 24488-001 HUMAN OTC DRUG Pain Relieving Ultra Strength Camphor, Menthol and Methyl Salicylate CREAM TOPICAL 20100331 UNAPPROVED DRUG OTHER Creation's Garden Natural Products, Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4.52; 11.3; 33.9 g/113g; g/113g; g/113g E 20171231 24488-001_b2afddf3-47c7-4277-91cc-dcae637ec9f4 24488-001 HUMAN OTC DRUG Pain Relieving Ultra Strength Camphor Menthol Methyl Salicylate CREAM TOPICAL 20100331 UNAPPROVED DRUG OTHER Creation's Garden Natural Products, Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 2.28; 5.7; 9 g/57g; g/57g; g/57g E 20171231 24488-002_2478517e-a395-46f4-805f-81b8de8689d2 24488-002 HUMAN OTC DRUG Pain ReliefRoll On Roll On Methyl Salicylate Mentol Camphor Capsaicin LIQUID TOPICAL 20100310 UNAPPROVED DRUG OTHER Creations Garden Natural Products, Inc. METHYL SALICYLATE; MENTHOL; CAMPHOR, (SYNTHETIC) 21; 7; 2.8 g/70g; g/70g; g/70g E 20171231 24488-003_1d5a462a-a513-44f0-a832-08185e26c922 24488-003 HUMAN OTC DRUG Boy Butter Extreme H2O Desensitizing Lubricant Benzocaine CREAM TOPICAL 20110627 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 4.25 g/85.05g E 20171231 24488-003_65541c40-dd2b-414d-b60b-a8908d3261f5 24488-003 HUMAN OTC DRUG Boy Butter Extreme H2O Desensitizing Lubricant Benzocaine CREAM TOPICAL 20110627 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 34.05 g/454g E 20171231 24488-003_74fda1b5-5bd6-4930-a283-315ca5ab791d 24488-003 HUMAN OTC DRUG Boy Butter Extreme Desensitizing Lubricant Benzocaine CREAM TOPICAL 20110523 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 34.05 g/454g E 20171231 24488-003_b7e1fc03-6123-404b-ad83-03e6e144f0b6 24488-003 HUMAN OTC DRUG Boy Butter Desensitizing Lubricant Benzocaine CREAM TOPICAL 20110523 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 6.39 g/85.2g E 20171231 24488-003_bdf08eb0-ed3d-4ce9-81fc-4e9ec5680603 24488-003 HUMAN OTC DRUG Boy Butter Extreme H2O Desensitizing Lubricant Benzocaine CREAM TOPICAL 20110520 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 7.1 g/142g E 20171231 24488-003_e87bcc36-5037-4afd-b9a8-b8f3cfa78029 24488-003 HUMAN OTC DRUG Boy Butter Desensitizing Lubricant Benzocaine CREAM TOPICAL 20110523 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 10.65 g/142g E 20171231 24488-004_0a03c383-b407-4022-9396-4a5fa1d3397f 24488-004 HUMAN OTC DRUG Revitol Acne Treatment Benzoyl Peroxide CREAM TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part333D Revitol Corporation BENZOYL PEROXIDE 2.95 mL/59mL E 20171231 24488-005_1a1b6bc1-5db5-4580-a83a-d846d3808582 24488-005 HUMAN OTC DRUG Hand Sanitizer Prevail alcohol SPRAY TOPICAL 20100412 UNAPPROVED DRUG OTHER Creation's Garden Natural Products, Inc ALCOHOL 4.58 mL/7.39mL E 20171231 24488-005_9553b10b-47ac-474e-b528-ecfa348d14c2 24488-005 HUMAN OTC DRUG Hand Sanitizer Prevail alcohol SPRAY TOPICAL 20100412 UNAPPROVED DRUG OTHER Creation's Garden Natural Products, Inc ALCOHOL 4.58 mL/7.39mL E 20171231 24488-005_ad1cec60-d57f-4392-b4f4-7b8f223e537b 24488-005 HUMAN OTC DRUG Creations Garden White Tea Quince Hand Sanitizer ethyl alcohol GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E Creations Garden Natural Products, Inc ALCOHOL 36.58 mL/59mL E 20171231 24488-005_c11c6f77-f559-45f1-9c68-182d075b61d9 24488-005 HUMAN OTC DRUG Creations Garden Pomegranate Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20110125 OTC MONOGRAPH NOT FINAL part333A Creations Garden Natural Products, Inc ALCOHOL 36.58 mL/59mL E 20171231 24488-006_321b53ad-4717-40be-ade0-2687c4ddf253 24488-006 HUMAN OTC DRUG True Essentials Hand Sanitizer BENZALKONIUM CHLORIDE LOTION TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part333E Fortune Hi-Tech BENZALKONIUM CHLORIDE .59 mL/59mL E 20171231 24488-008_5d2b1d8d-55c7-4df2-b745-4c233056cfdf 24488-008 HUMAN OTC DRUG Roccos Old School Tattoo Balm Anti Bacterial Wash Triclosan LIQUID TOPICAL 20110228 OTC MONOGRAPH NOT FINAL part333A Rocco's Old School TRICLOSAN 3.54 mL/118mL E 20171231 24488-009_260b397c-fd1e-4038-8e4a-a706ea78183e 24488-009 HUMAN OTC DRUG Roccos Old School Sunscreen SPF 30 Octinoxate CREAM TOPICAL 20110216 OTC MONOGRAPH NOT FINAL part352 Rocco's Old School OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 13.275; 10.62; 2.655 mL/177mL; mL/177mL; mL/177mL E 20171231 24488-010_fe61b4b2-3575-4817-9f7c-166f7e84d82e 24488-010 HUMAN OTC DRUG Roccos Old School Healing Balm Zinc Oxide CREAM TOPICAL 20110217 OTC MONOGRAPH NOT FINAL part348 Roccos Old School ZINC OXIDE .9 mL/30mL E 20171231 24488-011_a015ece3-75aa-45fc-9b3b-219fc87935cd 24488-011 HUMAN OTC DRUG Roccos Old School Peircing Armor Cetylpyridinium Chloride SPRAY TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part356 Rocco's Old School CETYLPYRIDINIUM CHLORIDE .027 mL/60mL E 20171231 24488-013_a45214f1-bbe5-46f8-9de1-2630498ab9f8 24488-013 HUMAN OTC DRUG Wartrol Wart Remover Salicylic Acid LIQUID TOPICAL 20110901 OTC MONOGRAPH FINAL part358B Pacific Naturals SALICYLIC ACID 2.51 mL/14.78mL E 20171231 24488-020_8d1a84b1-6378-43d4-b750-503b4dba43ab 24488-020 HUMAN OTC DRUG Prevail Pomegranate Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20110125 OTC MONOGRAPH NOT FINAL part333A Duane Reade ALCOHOL 36.58 mL/59mL E 20171231 24488-020_cd01b928-4261-42e3-8d69-57dba001822e 24488-020 HUMAN OTC DRUG Prevail Pomegranate Hand Sanitizer ethyl alcohol GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E Duane Reade ALCOHOL 146.32 mL/236mL E 20171231 24488-021_0b340153-fbc0-4b7d-a9e3-436d680ea5f3 24488-021 HUMAN OTC DRUG Prevail Hand Sanitizer Lemongrass alcohol GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E Duane Reade ALCOHOL 146.32 mL/236mL E 20171231 24488-021_97c9f79e-c271-452b-be74-2aa3cd782145 24488-021 HUMAN OTC DRUG Prevail Hand Sanitizer Lemongrass alcohol GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E Creation's Garden Natural Products, Inc ALCOHOL 36.58 mL/59mL E 20171231 24488-022_465710b3-5960-4588-b818-ea93d3296d6d 24488-022 HUMAN OTC DRUG Prevail White Tea Hand Sanitizer ethyl alcohol GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E Duane Reade ALCOHOL 146.32 mL/236mL E 20171231 24488-022_eae1cbb9-a72f-4019-ae49-81e389efaa7f 24488-022 HUMAN OTC DRUG Prevail Hand Sanitizer White Tea alcohol GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E Creation's Garden Natural Products, Inc ALCOHOL 36.58 mL/59mL E 20171231 24488-023_765259a5-6d84-4145-b9e3-3a6dd5206c4a 24488-023 HUMAN OTC DRUG Duane Reade hot and cold balm methyl salicylate and menthol SALVE TOPICAL 20110228 OTC MONOGRAPH NOT FINAL part348 Duane Reade METHYL SALICYLATE; MENTHOL 30.16; 7.9 mL/104mL; mL/104mL E 20171231 24488-023_fcbcce35-b447-4d0e-b5e1-06afaee3f5ea 24488-023 HUMAN OTC DRUG Duane Reade hot and cold roll-on Methyl Salicylate and Menthol GEL TOPICAL 20110228 OTC MONOGRAPH NOT FINAL part348 Duane Reade METHYL SALICYLATE; MENTHOL 21.46; 5.62 mL/74mL; mL/74mL E 20171231 24488-026_5aa64081-e673-49df-b108-26b6d7c9d86c 24488-026 HUMAN OTC DRUG MuscleCare Pain Relieving Camphor and Menthol GEL TOPICAL 20110623 OTC MONOGRAPH FINAL part341 Active and Innovative MENTHOL; CAMPHOR (SYNTHETIC) .17; .068 g/1.7g; g/1.7g E 20171231 24488-026_ad3b4c32-eff7-466a-91de-4b6bf1a0e5a1 24488-026 HUMAN OTC DRUG MuscleCare Professional Therapy Pain Relieving Camphor and Menthol GEL TOPICAL 20110621 OTC MONOGRAPH FINAL part341 Active and Innovative MENTHOL; CAMPHOR (SYNTHETIC) 8.5; 3.4 g/85g; g/85g E 20171231 24488-032_cc3fd08b-fc26-438f-933f-b0f1e508f181 24488-032 HUMAN OTC DRUG Duane Reade hydrocortisone plus 12 moisturizers hydrocortisone CREAM TOPICAL 20110328 OTC MONOGRAPH NOT FINAL part348 Duane Reade HYDROCORTISONE .284 g/287.4g E 20171231 24488-033_c8c131c2-1345-47a0-9ea3-cf08ae04dc1b 24488-033 HUMAN OTC DRUG Duane Reade hydrocortisone hydrocortisone CREAM TOPICAL 20110318 OTC MONOGRAPH NOT FINAL part348 Duane Reade HYDROCORTISONE .284 g/28.4g E 20171231 24488-034_0702c52c-8594-4a9d-8278-e924fa57e2b2 24488-034 HUMAN OTC DRUG Duane Reade hydrocortisone CREAM TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part348 Duane Reade HYDROCORTISONE .284 g/28.4g E 20171231 24488-035_1c45e0f4-9bb6-49f5-929c-e8fc7620e20f 24488-035 HUMAN OTC DRUG Duane Reade anti-itch DIPHENHYDRAMINE HYDROCHLORIDE CREAM TOPICAL 20110201 OTC MONOGRAPH FINAL part336 Duane Reade DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE ANHYDROUS .568; .284 g/28.4g; g/28.4g E 20171231 24488-036_f119c979-2cfc-471d-91df-98a6cf4504fd 24488-036 HUMAN OTC DRUG Bio 2 Brazilian Heat Brazilian Heat Menthol LIQUID TOPICAL 20120315 OTC MONOGRAPH FINAL part341 Bio 2 MENTHOL 4.2 mL/60mL E 20171231 24488-040_ae3fcc4e-4c22-4411-aa31-b6654141cb96 24488-040 HUMAN OTC DRUG KDS Lab Liquid Styptic LIDOCAINE HYDROCHLORIDE, ZINC CHLORIDE, ALCOHOL LIQUID TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part348 KDS Lab LIDOCAINE HYDROCHLORIDE; ZINC CHLORIDE; ALCOHOL 39.9680796; 400.018936; 199.975654 mg/mL; mg/mL; mg/mL E 20171231 24488-042_6d88ae7f-e65b-4922-ad03-e7ee347a7adb 24488-042 HUMAN OTC DRUG Boy Butter Desensitizing Lubricant Benzocaine CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 73.9395789 mg/mL E 20171231 24488-043_975672d1-cc6d-435d-b332-2e2deb94c221 24488-043 HUMAN OTC DRUG Boy Butter Desensitizing Lubricant Benzocaine CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part333B Boy Butter Lubes BENZOCAINE 71.9395789 mg/mL E 20171231 24492-850_bc5148ba-ad0e-46c1-b3d0-caf52b15ad11 24492-850 HUMAN PRESCRIPTION DRUG Kitabis Pak Tobramycin SOLUTION RESPIRATORY (INHALATION) 20150219 NDA NDA205433 Pari Respiratory Equipment TOBRAMYCIN 300 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 24510-110_9670cffb-1222-4756-8a24-c69d5b8dc435 24510-110 HUMAN PRESCRIPTION DRUG XTAMPZA ER OXYCODONE CAPSULE, EXTENDED RELEASE ORAL 20160510 NDA NDA208090 Collegium Pharmaceutical, Inc. OXYCODONE 9 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 24510-115_9670cffb-1222-4756-8a24-c69d5b8dc435 24510-115 HUMAN PRESCRIPTION DRUG XTAMPZA ER OXYCODONE CAPSULE, EXTENDED RELEASE ORAL 20160510 NDA NDA208090 Collegium Pharmaceutical, Inc. OXYCODONE 13.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 24510-120_9670cffb-1222-4756-8a24-c69d5b8dc435 24510-120 HUMAN PRESCRIPTION DRUG XTAMPZA ER OXYCODONE CAPSULE, EXTENDED RELEASE ORAL 20160510 NDA NDA208090 Collegium Pharmaceutical, Inc. OXYCODONE 18 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 24510-130_9670cffb-1222-4756-8a24-c69d5b8dc435 24510-130 HUMAN PRESCRIPTION DRUG XTAMPZA ER OXYCODONE CAPSULE, EXTENDED RELEASE ORAL 20160510 NDA NDA208090 Collegium Pharmaceutical, Inc. OXYCODONE 27 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 24510-140_9670cffb-1222-4756-8a24-c69d5b8dc435 24510-140 HUMAN PRESCRIPTION DRUG XTAMPZA ER OXYCODONE CAPSULE, EXTENDED RELEASE ORAL 20160510 NDA NDA208090 Collegium Pharmaceutical, Inc. OXYCODONE 36 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 24533-001_44459b17-e96b-41be-a0b6-934ea7181797 24533-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20111128 UNAPPROVED MEDICAL GAS Melo's Gas and Gear, Inc. OXYGEN 990 mL/L E 20171231 24533-002_a69fc716-2e2b-4ba8-8415-8ddec912fe45 24533-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20120501 UNAPPROVED MEDICAL GAS Melo's Gas and Gear, Inc. NITROGEN 990 mL/L E 20171231 24535-0801_b826b788-446f-49c9-bca2-2a3e7bbc43eb 24535-0801 HUMAN PRESCRIPTION DRUG LETROZOLE LETROZOLE TABLET, FILM COATED ORAL 20160603 ANDA ANDA203796 Arab Pharmaceutical Manufacturing Co. PSC Ltd LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 24535-0831_8ff7b994-411f-481b-9923-311a1e3505c6 24535-0831 HUMAN PRESCRIPTION DRUG Hydroxyurea Hydroxyurea CAPSULE ORAL 20170820 ANDA ANDA204998 Arab Pharmaceutical Manufacturing Co. PSC Ltd HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] E 20171231 24559-001_60ef3722-015d-7177-e053-2991aa0a9f72 24559-001 HUMAN OTC DRUG INTELLIGENT BEAUTY LABS Age Defying Day Broad Spectrum SPF 20 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20130125 OTC MONOGRAPH NOT FINAL part352 DermStore, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 20; 75; 46 mg/mL; mg/mL; mg/mL N 20181231 24559-080_892ce84c-78f4-4323-a157-fe83fc1e2549 24559-080 HUMAN OTC DRUG After Shave Broad Spectrum SPF 15 Avobenzone, Octocrylene, Phenylbenzimidazole Sulfonic Acid LOTION TOPICAL 20131219 OTC MONOGRAPH NOT FINAL part352 Dermstore, LLC AVOBENZONE; OCTOCRYLENE; ENSULIZOLE 3; 2.7; 4 g/100mL; g/100mL; g/100mL E 20171231 24562-001_96c63d8c-225c-4270-9104-0e48b4b52ad9 24562-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20150514 ANDA ANDA203710 Biomedical Research Foundation of Northwest Louisiana FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24562-002_418b5509-1aa4-4cef-9aaa-5a246ea29f10 24562-002 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION, SOLUTION INTRAVENOUS 20150122 ANDA ANDA204351 Biomedial Research Foundation of Northwest Lousiansa SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24562-003_dd0987dd-95fc-4d68-9d84-edc53ebe0257 24562-003 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20150514 ANDA ANDA203837 Biomedical Research Foundation of Northwest Louisiana FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24562-004_96e9bde0-681a-452c-9514-6e2ec4ab2c0e 24562-004 HUMAN PRESCRIPTION DRUG Ammonia N 13 Ammonia N-13 INJECTION, SOLUTION INTRAVENOUS 20150514 ANDA ANDA204352 Biomedical Research Foundation of Northwest Louisiana AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 24571-102_de471206-dcf9-4219-8282-1d6e48141f93 24571-102 HUMAN PRESCRIPTION DRUG PRISMASOL BGK2/0 magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Baxter Healthcare Corporation MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, L-; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE .102; 1.1; .27; 6.136; 2.688; .149 g/L; g/L; g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 24571-103_de471206-dcf9-4219-8282-1d6e48141f93 24571-103 HUMAN PRESCRIPTION DRUG PRISMASOL BGK2/3.5 calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Baxter Healthcare Corporation CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; LACTIC ACID, L-; SODIUM BICARBONATE; POTASSIUM CHLORIDE .257; .102; 1.1; 6.136; .27; 2.688; .149 g/L; g/L; g/L; g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 24571-104_de471206-dcf9-4219-8282-1d6e48141f93 24571-104 HUMAN PRESCRIPTION DRUG PRISMASOL BGK4/3.5 calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Baxter Healthcare Corporation CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, L-; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE .257; .102; 1.1; .27; 6.136; 2.688; .298 g/L; g/L; g/L; g/L; g/L; g/L; g/L Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 24571-105_de471206-dcf9-4219-8282-1d6e48141f93 24571-105 HUMAN PRESCRIPTION DRUG PRISMASOL BGK4/2.5 calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride sodium bicarbonate, and potassium chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Baxter Healthcare Corporation CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, L-; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE .184; .153; 1.1; .27; 6.136; 2.688; .298 g/L; g/L; g/L; g/L; g/L; g/L; g/L Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 24571-108_de471206-dcf9-4219-8282-1d6e48141f93 24571-108 HUMAN PRESCRIPTION DRUG PRISMASOL BGK0/2.5 calcium chloride, magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride and sodium bicarbonate SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Baxter Healthcare Corporation CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, L-; SODIUM CHLORIDE; SODIUM BICARBONATE .184; .153; 1.1; .27; 6.136; 2.688 g/L; g/L; g/L; g/L; g/L; g/L Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 24571-111_de471206-dcf9-4219-8282-1d6e48141f93 24571-111 HUMAN PRESCRIPTION DRUG PRISMASOL B22GK4/0 magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Baxter Healthcare Corporation MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, L-; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE .153; 1.1; .27; 6.721; 1.848; .298 g/L; g/L; g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 24571-113_de471206-dcf9-4219-8282-1d6e48141f93 24571-113 HUMAN PRESCRIPTION DRUG PRISMASOL BK0/0/1.2 magnesium chloride, lactic acid, sodium chloride and sodium bicarbonate SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Baxter Healthcare Corporation MAGNESIUM CHLORIDE; LACTIC ACID, L-; SODIUM CHLORIDE; SODIUM BICARBONATE .122; .27; 6.136; 2.688 g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 24571-114_de471206-dcf9-4219-8282-1d6e48141f93 24571-114 HUMAN PRESCRIPTION DRUG PRISMASOL BGK4/0/1.2 magnesium chloride, dextrose monohydrate, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride SOLUTION INTRAVENOUS 20061025 NDA NDA021703 Baxter Healthcare Corporation MAGNESIUM CHLORIDE; DEXTROSE MONOHYDRATE; LACTIC ACID, L-; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE .122; 1.1; .27; 6.136; 2.688; .298 g/L; g/L; g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 24571-116_de471206-dcf9-4219-8282-1d6e48141f93 24571-116 HUMAN PRESCRIPTION DRUG PHOXILLUM BK4/2.5 calcium chloride, magnesium chloride, sodium chloride, potassium chloride, sodium phosphate dibasic dihydrate, and sodium bicarbonate SOLUTION INTRAVENOUS 20150113 NDA NDA207026 Baxter Healthcare Corporation CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC DIHYDRATE; SODIUM BICARBONATE .184; .153; 6.019; .298; .178; 2.688 g/L; g/L; g/L; g/L; g/L; g/L Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 24571-117_de471206-dcf9-4219-8282-1d6e48141f93 24571-117 HUMAN PRESCRIPTION DRUG PHOXILLUM B22K4/0 magnesium chloride, sodium chloride, potassium chloride, sodium phosphate dibasic dihydrate and sodium bicarbonate SOLUTION INTRAVENOUS 20150113 NDA NDA207026 Baxter Healthcare Corporation MAGNESIUM CHLORIDE; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC DIHYDRATE; SODIUM BICARBONATE .153; 6.603; .298; .178; 1.848 g/L; g/L; g/L; g/L; g/L Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 24598-0121_9e92ff57-b91e-4604-9f84-7094584dc4fc 24598-0121 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060513 UNAPPROVED MEDICAL GAS Special Care Medical OXYGEN 99 L/100L E 20171231 24600-6407_07c983ae-a9ad-4e5b-b665-c08ddc8b99ef 24600-6407 HUMAN OTC DRUG MORTON Natural Epsom Salt MAGNESIUM SULFATE GRANULE, FOR SOLUTION ORAL; TOPICAL 20120901 OTC MONOGRAPH FINAL part334 Morton Salt, Inc. MAGNESIUM SULFATE 1 kg/kg N 20181231 24623-001_87cf3278-1d2b-4c3c-8fd8-d1ab091b0929 24623-001 HUMAN OTC DRUG Advanced Protection SPF-15 OCTINOXATE and Zinc Oxide CREAM TOPICAL 20010825 OTC MONOGRAPH NOT FINAL part352 CBI Laboratories, Inc OCTINOXATE; ZINC OXIDE .075; .05 g/g; g/g E 20171231 24623-042_bb41140c-ef5b-4c97-96a2-4a0af804f5e1 24623-042 HUMAN OTC DRUG Advanced Lightning OCTINOXATE and HYDROQUINONE CREAM TOPICAL 20050701 OTC MONOGRAPH NOT FINAL part352 CBI Laboratories, Inc OCTINOXATE; HYDROQUINONE .02; .02 g/g; g/g E 20171231 24623-044_5c06014f-55bf-4461-a3b7-1e6f37c84e77 24623-044 HUMAN OTC DRUG R-044 Blemish Fix SALICYLIC ACID LIQUID TOPICAL 20060328 OTC MONOGRAPH FINAL part333D CBI Laboratories, Inc SALICYLIC ACID 2 mg/mL E 20171231 24623-047_d03ca55c-0dd2-43c2-ad09-94238998b2b9 24623-047 HUMAN OTC DRUG Tinted Moisturizer SPF20 Light OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part352 CBI Laboratories, Inc OCTINOXATE; TITANIUM DIOXIDE .05; .037 g/g; g/g E 20171231 24623-048_be6b98e6-a896-4556-a3dc-d372afc70f4a 24623-048 HUMAN OTC DRUG Tinted Moisturizer SPF20 Medium OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part352 CBI Laboratories, Inc OCTINOXATE; TITANIUM DIOXIDE .05; .042 g/g; g/g E 20171231 24623-049_05d0592d-18b2-4f2f-8ac2-476748e97b1d 24623-049 HUMAN OTC DRUG Tinted Moisturizer SPF20 Dark OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part352 CBI Laboratories, Inc OCTINOXATE; TITANIUM DIOXIDE .05; .042 g/g; g/g E 20171231 24653-010_1e615f73-0d43-3ddc-e054-00144ff88e88 24653-010 HUMAN OTC DRUG Rich Nutrient Skin Refiner Octyl methoxycinnamate, octocrylene cream CREAM TOPICAL 20150803 OTC MONOGRAPH FINAL part352 Janssen Cosmetics GmbH OCTINOXATE; OCTOCRYLENE 2.25; .9 g/50mL; g/50mL E 20171231 24653-011_77ae783e-cda1-4c8b-9c25-d3d3a9fd8a3a 24653-011 HUMAN OTC DRUG Optimal Tinted Complexion ethylhexl methoxycinnamate CREAM TOPICAL 20120920 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE 3.5 g/50mL E 20171231 24653-270_17e64293-87d8-42db-a080-5ded3be0d591 24653-270 HUMAN OTC DRUG CC Cream Light Octocrylene and Octinoxate CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTOCRYLENE; OCTINOXATE 3; 2.25 g/30mL; g/30mL E 20171231 24653-271_17e64293-87d8-42db-a080-5ded3be0d591 24653-271 HUMAN OTC DRUG CC Cream Medium Octocrylene and Octinoxate CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTOCRYLENE; OCTINOXATE 3; 2.25 g/30mL; g/30mL E 20171231 24653-282_03f16424-f02a-4ab7-8a1d-f5e9fb0fc870 24653-282 HUMAN OTC DRUG BB Cream Titanium Dioxide CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH TITANIUM DIOXIDE 3.42 g/30mL E 20171231 24653-283_40ce0875-390e-5a23-e054-00144ff88e88 24653-283 HUMAN OTC DRUG Face Guard Advanced Octinoxate, Octocrylene, Titanium Dioxide Cream CREAM TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE .3; 2.248; 1.8 g/30mL; g/30mL; g/30mL E 20171231 24653-286_feced253-c701-418c-a09b-71814671bdc4 24653-286 HUMAN OTC DRUG BB Cream Medium Titanium Dioxide CREAM TOPICAL 20140210 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH TITANIUM DIOXIDE 3.42 g/30mL E 20171231 24653-310_aebad75e-f667-4806-a5aa-e9bd0576fc28 24653-310 HUMAN OTC DRUG Melafadin Day Protection Titanium Dioxide, Octinoxate, Octocrylene CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE .3; 1.8; 2.25 g/50mL; g/50mL; g/50mL E 20171231 24653-800_710340a0-3f2f-4355-8851-03998a2ba8a4 24653-800 HUMAN OTC DRUG Long Last Makeup 00 Octinoxate CREAM TOPICAL 20121005 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE 1.8 g/30mL E 20171231 24653-801_710340a0-3f2f-4355-8851-03998a2ba8a4 24653-801 HUMAN OTC DRUG Long Last Makeup 01 Octinoxate CREAM TOPICAL 20081010 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE 1.8 g/30mL E 20171231 24653-802_710340a0-3f2f-4355-8851-03998a2ba8a4 24653-802 HUMAN OTC DRUG Long Last Makeup 05 Octinoxate CREAM TOPICAL 20120110 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE 1.8 g/30mL E 20171231 24653-803_710340a0-3f2f-4355-8851-03998a2ba8a4 24653-803 HUMAN OTC DRUG Long Last Makeup 03 Octinoxate CREAM TOPICAL 20081010 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE 1.8 g/30mL E 20171231 24653-805_2fe6a69b-2f80-49f0-818c-4912d6302c91 24653-805 HUMAN OTC DRUG Long Last Make UP 02 (Neo Heliopan) Ethylhexyl methoxycinnamate CREAM TOPICAL 20081010 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE 6 mL/30mL E 20171231 24653-816_4b0df926-8098-428f-bea5-8e264cbd5e32 24653-816 HUMAN OTC DRUG FACE GUARD 15 Titanium Dioxide CREAM TOPICAL 20121002 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH TITANIUM DIOXIDE 4.2 g/100mL E 20171231 24653-830_844d4da2-b598-4b01-9703-4cb614ceff28 24653-830 HUMAN OTC DRUG Face Guard 30 SPF Octinoxate and titanium dioxide CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Janssen Cosmetics GmbH OCTINOXATE; TITANIUM DIOXIDE 3.5; .5 g/50mL; g/50mL E 20171231 24658-170_60133fed-34e6-a6d6-e053-2a91aa0a858d 24658-170 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20161101 20200831 NDA AUTHORIZED GENERIC NDA020401 PuraCap Laboratories LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 24658-171_60133fed-34e6-a6d6-e053-2a91aa0a858d 24658-171 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20161101 20200831 NDA AUTHORIZED GENERIC NDA020401 PuraCap Laboratories LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 24658-172_60133fed-34e6-a6d6-e053-2a91aa0a858d 24658-172 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20161101 NDA AUTHORIZED GENERIC NDA020401 PuraCap Laboratories LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 24658-173_60133fed-34e6-a6d6-e053-2a91aa0a858d 24658-173 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20161101 NDA AUTHORIZED GENERIC NDA020401 PuraCap Laboratories LLC DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 24658-174_60133fed-34e6-a6d6-e053-2a91aa0a858d 24658-174 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20161101 NDA AUTHORIZED GENERIC NDA020401 PuraCap Laboratories LLC DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 24658-185_6e6359ca-0152-41a2-b69d-0f6c158d018b 24658-185 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET ORAL 20040910 20200531 ANDA ANDA076639 PuraCap Laboratories LLC dba Blu Pharmaceuticals CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 24658-260_60e2a02c-f95a-6478-e053-2a91aa0a2ddc 24658-260 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20110401 ANDA ANDA078012 PuraCap Laboratories LLC dba Blu Pharmaceuticals GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 24658-312_ff4d8f65-9251-4ce6-a912-cda178b73efa 24658-312 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20131125 ANDA ANDA062269 PuraCap Laboratories LLC dba Blu Pharmaceuticals DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 24658-341_35ba00e6-35c3-4407-9f25-f0a293387671 24658-341 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 PuraCap Laboratories LLC dba Blu Pharmaceuticals DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 24658-342_35ba00e6-35c3-4407-9f25-f0a293387671 24658-342 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 PuraCap Laboratories LLC dba Blu Pharmaceuticals DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 24658-343_35ba00e6-35c3-4407-9f25-f0a293387671 24658-343 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 PuraCap Laboratories LLC dba Blu Pharmaceuticals DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 24658-344_35ba00e6-35c3-4407-9f25-f0a293387671 24658-344 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 PuraCap Laboratories LLC dba Blu Pharmaceuticals DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 24658-345_35ba00e6-35c3-4407-9f25-f0a293387671 24658-345 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 PuraCap Laboratories LLC dba Blu Pharmaceuticals DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 24658-346_60133fed-34e6-a6d6-e053-2a91aa0a858d 24658-346 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20161101 NDA AUTHORIZED GENERIC NDA020401 PuraCap Laboratories LLC DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 24658-700_60e21b93-f927-1fdb-e053-2991aa0ac877 24658-700 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20160822 ANDA ANDA075541 PuraCap Laboratories LLC dba Blu Pharmaceuticals BETAXOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24658-701_60e21b93-f927-1fdb-e053-2991aa0ac877 24658-701 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20160822 ANDA ANDA075541 PuraCap Laboratories LLC dba Blu Pharmaceuticals BETAXOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 24658-710_88e03cb0-25f5-41a5-b77f-58ab8f3be181 24658-710 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20171007 ANDA ANDA065447 PuraCap Laboratories LLC DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 24658-711_88e03cb0-25f5-41a5-b77f-58ab8f3be181 24658-711 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20171007 ANDA ANDA065447 PuraCap Laboratories LLC DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 24658-720_60e23697-5645-5971-e053-2a91aa0ae9a5 24658-720 HUMAN PRESCRIPTION DRUG Flavoxate Hydrochloride Flavoxate Hydrochloride TABLET ORAL 20161215 ANDA ANDA076835 PuraCap Laboratories LLC dba Blu Pharmaceuticals FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 24658-730_60e24f24-7fdf-768a-e053-2a91aa0a7037 24658-730 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 20161114 ANDA ANDA074673 PuraCap Laboratories LLC dba Blu Pharmaceuticals GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 24658-731_60e24f24-7fdf-768a-e053-2a91aa0a7037 24658-731 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 20161114 ANDA ANDA074673 PuraCap Laboratories LLC dba Blu Pharmaceuticals GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 24658-750_60e2746f-7e31-260a-e053-2a91aa0aeea2 24658-750 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride CAPSULE ORAL 20161215 ANDA ANDA074928 PuraCap Laboratories LLC dba Blu Pharmaceuticals NICARDIPINE HYDROCHLORIDE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 24658-751_60e2746f-7e31-260a-e053-2a91aa0aeea2 24658-751 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride CAPSULE ORAL 20161215 ANDA ANDA074928 PuraCap Laboratories LLC dba Blu Pharmaceuticals NICARDIPINE HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 24658-760_60e2746f-7e65-260a-e053-2a91aa0aeea2 24658-760 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate POWDER, FOR SUSPENSION ORAL 20161215 ANDA ANDA202333 PuraCap Laboratories LLC dba Blu Pharmaceuticals SODIUM POLYSTYRENE SULFONATE 4.1 meq/g N 20181231 24658-770_60e2116a-5bd5-312c-e053-2a91aa0a06ef 24658-770 HUMAN PRESCRIPTION DRUG SULINDAC SULINDAC TABLET ORAL 20161114 ANDA ANDA072710 PuraCap Laboratories LLC dba Blu Pharmaceuticals SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 24658-771_60e2116a-5bd5-312c-e053-2a91aa0a06ef 24658-771 HUMAN PRESCRIPTION DRUG SULINDAC SULINDAC TABLET ORAL 20161114 ANDA ANDA072711 PuraCap Laboratories LLC dba Blu Pharmaceuticals SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 24658-780_9d7f26d5-d8a9-4610-8d78-80ca3d442a79 24658-780 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20161215 ANDA ANDA075517 PuraCap Laboratories, LLC URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 24658-790_60e2594f-cf67-8680-e053-2991aa0a535d 24658-790 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20160401 ANDA ANDA075965 PuraCap Laboratories LLC dba Blu Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 24658-791_60e2594f-cf67-8680-e053-2991aa0a535d 24658-791 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20160401 ANDA ANDA075965 PuraCap Laboratories LLC dba Blu Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 24658-792_60e2594f-cf67-8680-e053-2991aa0a535d 24658-792 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20160401 ANDA ANDA075965 PuraCap Laboratories LLC dba Blu Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 24663-000_e74801d8-0dc5-47f1-bb3a-5ed4677bf3ae 24663-000 HUMAN OTC DRUG 29 by LYDIA MONDAVI Napa Valley BROAD SPECTRUM SPF 30 D VINE DAY AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part352 29 Luxury Goods, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 20; 25 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 24670-0001_a4a6564c-9252-46d0-acab-8ba7bc8494d7 24670-0001 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20130211 UNAPPROVED MEDICAL GAS Line Pressure NITROGEN 99 L/100L E 20171231 24673-247_12af8eb4-2905-49d6-bbab-fc5f5f539d29 24673-247 HUMAN OTC DRUG Derma-Glove Triclosan SOAP TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333 RWM TECHNOLOGIES TRICLOSAN .03 g/g E 20171231 24673-248_77453def-d7fa-4cb6-8aaa-58c41de3cb58 24673-248 HUMAN OTC DRUG Derma-Glove Ethanol, Triclosan GEL TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333 RWM TECHNOLOGIES ETHANOL; TRICLOSAN .58; .03 g/g; g/g E 20171231 24673-249_d3894ea4-022f-41b4-b1d2-59e0fcaef923 24673-249 HUMAN OTC DRUG Derma-Glove Ethanol, Triclosan SPRAY TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333 RWM TECHNOLOGIES ETHANOL; TRICLOSAN .58; .003 g/g; g/g E 20171231 24694-001_acbfb24f-e79a-4022-9a86-5acba0c5dbeb 24694-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19980101 NDA NDA205849 Greenville Truck and Welding Supplies LLC OXYGEN 99 L/100L N 20181231 24724-028_9e4deae4-c73a-4d5f-94bf-a7ca02a813ad 24724-028 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL TABLET, FILM COATED ORAL 20110615 ANDA ANDA201634 INDICUS PHARMA LLC DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 24724-029_9e4deae4-c73a-4d5f-94bf-a7ca02a813ad 24724-029 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL TABLET, FILM COATED ORAL 20110615 ANDA ANDA201634 INDICUS PHARMA LLC DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 24724-030_f0d36846-d476-4206-99e7-51c7ae6b650a 24724-030 HUMAN PRESCRIPTION DRUG LETROZOLE LETROZOLE TABLET ORAL 20110615 ANDA ANDA201804 INDICUS PHARMA LLC LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 24724-067_494d7b7e-4fdc-4d1a-8b7e-4a8b163b4ab0 24724-067 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20160801 ANDA ANDA207433 INDICUS PHARMA LLC DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 24724-068_494d7b7e-4fdc-4d1a-8b7e-4a8b163b4ab0 24724-068 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20160801 ANDA ANDA207433 INDICUS PHARMA LLC DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 24724-069_494d7b7e-4fdc-4d1a-8b7e-4a8b163b4ab0 24724-069 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20160801 ANDA ANDA207433 INDICUS PHARMA LLC DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 24724-070_494d7b7e-4fdc-4d1a-8b7e-4a8b163b4ab0 24724-070 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20160801 ANDA ANDA207433 INDICUS PHARMA LLC DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 24724-071_494d7b7e-4fdc-4d1a-8b7e-4a8b163b4ab0 24724-071 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20160801 ANDA ANDA207433 INDICUS PHARMA LLC DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 24724-072_494d7b7e-4fdc-4d1a-8b7e-4a8b163b4ab0 24724-072 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET ORAL 20160801 ANDA ANDA207433 INDICUS PHARMA LLC DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] E 20171231 24765-100_edb22a90-fd3a-4510-aa55-af050daf0220 24765-100 HUMAN OTC DRUG Dental Clear Natural SODIUM FLUORIDE RINSE ORAL 20111201 OTC MONOGRAPH FINAL part355 Pharmacal-International. Co., Ltd. SODIUM FLUORIDE .05 mL/100mL N 20181231 24765-101_5f64d680-59ec-4e76-bcdf-f98d6b55afd5 24765-101 HUMAN OTC DRUG Olidental Check Gargle SODIUM FLUORIDE RINSE ORAL 20111201 OTC MONOGRAPH FINAL part355 Pharmacal-International. Co., Ltd. SODIUM FLUORIDE .0154 g/770mL N 20181231 24765-102_9494bced-35e2-43da-a79a-48b0948103c2 24765-102 HUMAN OTC DRUG Dr. Cellmo NIACINAMIDE SHAMPOO TOPICAL 20160804 UNAPPROVED DRUG OTHER Pharmacal-International. Co., Ltd. NIACINAMIDE .51 mg/510mL N 20181231 24765-103_a8e3fa4e-30ff-4308-8107-8f548a99665f 24765-103 HUMAN OTC DRUG i Cellestin GLYCERIN CREAM TOPICAL 20160804 UNAPPROVED DRUG OTHER Pharmacal-International. Co., Ltd. GLYCERIN .175 mg/5mL N 20181231 24765-104_2bd995a4-6f4f-4e1f-917d-e1ed1c385858 24765-104 HUMAN OTC DRUG Dr. Serse GLYCERIN CREAM TOPICAL 20161007 UNAPPROVED DRUG OTHER Pharmacal-International. Co., Ltd. GLYCERIN .175 mg/5mL N 20181231 24765-105_38faf8c8-f7c0-42ed-8806-16b02bba1377 24765-105 HUMAN OTC DRUG myCellCare GLYCERIN CREAM TOPICAL 20161007 UNAPPROVED DRUG OTHER Pharmacal-International. Co., Ltd. GLYCERIN .175 mg/5mL N 20181231 24765-106_47b0f012-ff07-3800-e054-00144ff8d46c 24765-106 HUMAN OTC DRUG eVESERUM GLYCERIN LOTION TOPICAL 20170129 UNAPPROVED DRUG OTHER Pharmacal-International. Co., Ltd. GLYCERIN 35 mg/mL N 20181231 24765-107_32f8869e-0c98-4b51-b401-966d8fb10bac 24765-107 HUMAN OTC DRUG Mycellcare Feminine Cleanser GLYCERIN,HYDROXYETHYL ETHYLCELLULOSE ,ALLANTOIN LIQUID TOPICAL 20170816 UNAPPROVED DRUG OTHER PHARMACAL-INTERNATIONAL. CO., LTD GLYCERIN; HYDROXYETHYL ETHYLCELLULOSE; ALLANTOIN 4.16; 2.8; .728 g/100mL; g/100mL; g/100mL N 20181231 24765-108_1d81d3f3-55aa-470e-aa4d-86db80515527 24765-108 HUMAN OTC DRUG Mycellcare All in One Serum GLYCERIN,NIACINAMIDE ,GLYCERYL MONOSTEARATE ,ALLANTOIN LIQUID TOPICAL 20170816 UNAPPROVED DRUG OTHER PHARMACAL-INTERNATIONAL. CO., LTD GLYCERIN; NIACINAMIDE; GLYCERYL MONOSTEARATE; ALLANTOIN 4.16; 2.8; .728; .145 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 24765-109_fe419430-2355-4b70-8ede-44fa9e73a37b 24765-109 HUMAN OTC DRUG Cellzyme Secret Therapy GLYCERIN,HYDROXYETHYL ETHYLCELLULOSE ,ALLANTOIN LIQUID TOPICAL 20170816 OTC MONOGRAPH NOT FINAL part334 PHARMACAL-INTERNATIONAL. CO., LTD GLYCERIN; HYDROXYETHYL ETHYLCELLULOSE; ALLANTOIN 5.2; 1.925; .145 g/100mL; g/100mL; g/100mL N 20181231 24765-110_4cd8dd54-a0e6-4176-be25-bcf8c6ea26fa 24765-110 HUMAN OTC DRUG Cellzyme Ampoule Glycerin, Eucalyptus Oil, Allantoin LIQUID TOPICAL 20170816 OTC MONOGRAPH NOT FINAL part348 PHARMACAL-INTERNATIONAL. CO., LTD GLYCERIN; EUCALYPTUS OIL; ALLANTOIN 9.1; .092; .043 g/100mL; g/100mL; g/100mL N 20181231 24765-111_1d7e4cfa-5a48-4d35-8b8b-c10b785e3996 24765-111 HUMAN OTC DRUG Cellzyme ON-TOX Peppermint Oil Eucalyptus Oil Ferric Oxide Red CREAM TOPICAL 20170816 OTC MONOGRAPH NOT FINAL part356 PHARMACAL-INTERNATIONAL. CO., LTD PEPPERMINT OIL; EUCALYPTUS OIL; FERRIC OXIDE RED .089; .092; .084 g/100g; g/100g; g/100g N 20181231 24765-112_4ad67ebc-e808-4b1a-a78e-01c10622add2 24765-112 HUMAN OTC DRUG Cellzyme Secret Therapy 3845 Glycerine, EucalyptusOil, Allantoin CREAM TOPICAL 20170816 OTC MONOGRAPH NOT FINAL part348 PHARMACAL-INTERNATIONAL. CO., LTD GLYCERIN; ALLANTOIN; POWDERED CELLULOSE 5.2; .145; .0015 g/100mL; g/100mL; g/100mL N 20181231 24765-113_44d8c9d9-4e82-47fd-b4d2-e24ac119e30d 24765-113 HUMAN OTC DRUG Cellzyme ON-TOX Peppermint Oil Eucalyptus Oil Ferric Oxide Red CREAM TOPICAL 20170816 OTC MONOGRAPH NOT FINAL part356 PHARMACAL-INTERNATIONAL. CO., LTD PEPPERMINT OIL; EUCALYPTUS OIL; FERRIC OXIDE RED .089; .092; .084 g/100g; g/100g; g/100g N 20181231 24765-114_550832b8-eab5-4cf5-83a9-4cf526e71a28 24765-114 HUMAN OTC DRUG Cellzyme Ampoule Glycerin, Eucalyptus Oil, Allantoin LIQUID TOPICAL 20170816 OTC MONOGRAPH NOT FINAL part348 PHARMACAL-INTERNATIONAL. CO., LTD GLYCERIN; EUCALYPTUS OIL; ALLANTOIN 9.1; .092; .043 g/100mL; g/100mL; g/100mL N 20181231 24765-115_101dfbf5-e488-4971-9b82-2f0c99b195b8 24765-115 HUMAN OTC DRUG Cellzyme ON-TOX Peppermint Oil Eucalyptus Oil Ferric Oxide Red CREAM TOPICAL 20170816 OTC MONOGRAPH NOT FINAL part356 PHARMACAL-INTERNATIONAL. CO., LTD PEPPERMINT OIL; EUCALYPTUS OIL; FERRIC OXIDE RED .089; .092; .084 g/100mL; g/100mL; g/100mL N 20181231 24765-117_9ed793a0-03d3-4ce1-9dca-7d0aa3b77ddb 24765-117 HUMAN OTC DRUG Cellzyme Secret Therapy 3845 Glycerine, EucalyptusOil, Allantoin CREAM TOPICAL 20170816 OTC MONOGRAPH NOT FINAL part348 PHARMACAL-INTERNATIONAL. CO., LTD GLYCERIN; ALLANTOIN; POWDERED CELLULOSE 5.2; .145; .0015 g/100mL; g/100mL; g/100mL N 20181231 24781-0001_7aa76967-8f9f-4d38-8389-1723c0a00212 24781-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060919 UNAPPROVED MEDICAL GAS Apollo Services Inc. OXYGEN 99 L/100L E 20171231 24794-100_e2a3a488-4dec-4b72-86cc-6c6d9ec74eaf 24794-100 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 24794-101_3e777395-fda4-487a-b778-547b939e4885 24794-101 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 24794-102_c919b17f-9910-4ca5-8424-e50d6c674a59 24794-102 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 24794-103_6347b23a-1714-4b3e-af29-e2876014c8bf 24794-103 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 24794-104_e52c559d-0b92-4ae1-a4fc-79ca9493ff5d 24794-104 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 24794-105_5e13e43e-43dc-4f57-a722-4e6a626a8630 24794-105 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 24794-106_e59f812e-e203-4fa9-86b1-f9963a4ff599 24794-106 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 24794-107_f0695154-86a3-44bc-a2fd-18f9527b01f0 24794-107 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 24794-108_9cebdcfa-33f3-4093-ace3-07fe70906223 24794-108 HUMAN PRESCRIPTION DRUG Zap Neutral Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 4.086 g/454g N 20181231 24794-109_3b5dbe97-9afb-4dde-88e3-da48109fa346 24794-109 HUMAN PRESCRIPTION DRUG Zap APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Crosstex International Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 24794-220_390aae59-50b0-4f44-a054-7e6053723894 24794-220 HUMAN OTC DRUG Gumnumb Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Crosstex International Inc. BENZOCAINE 200 mg/g N 20181231 24794-221_8081cf83-a18f-4198-8ece-22d9953dcaf8 24794-221 HUMAN OTC DRUG Gumnumb Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Crosstex International Inc. BENZOCAINE 200 mg/g N 20181231 24794-222_ce24f024-e31f-4a8c-88a2-026fd7ab8de3 24794-222 HUMAN OTC DRUG Gumnumb Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Crosstex International Inc. BENZOCAINE 200 mg/g N 20181231 24794-223_596e8f16-d192-422e-a613-947e1dbaed83 24794-223 HUMAN OTC DRUG Gumnumb Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Crosstex International Inc. BENZOCAINE 200 mg/g N 20181231 24794-224_2471e91a-b1e1-413e-b700-a405cde7171f 24794-224 HUMAN OTC DRUG Gumnumb Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Crosstex International Inc. BENZOCAINE 200 mg/g N 20181231 24794-225_62569de0-30b7-4a82-9393-519b3af0efba 24794-225 HUMAN OTC DRUG Gumnumb Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Crosstex International Inc. BENZOCAINE 200 mg/g N 20181231 24794-300_e4c829ac-fdf0-4d06-8c6f-f71b1febc811 24794-300 HUMAN PRESCRIPTION DRUG Hemostatic Solution Aluminum Chloride SOLUTION DENTAL 20130115 UNAPPROVED DRUG OTHER Crosstex International Inc. ALUMINUM CHLORIDE 7500 mg/30mL N 20181231 24839-699_83b1a11a-dd01-4dc6-aaac-ad33aba4017a 24839-699 HUMAN PRESCRIPTION DRUG UTA Methenamine, Sodium Phosphate Monobasic, Methylene Blue, Hyoscyamine Sulfate CAPSULE ORAL 20140926 UNAPPROVED DRUG OTHER SJ PHARMACEUTICALS, LLC METHENAMINE; METHYLENE BLUE; HYOSCYAMINE SULFATE; SODIUM PHOSPHATE, MONOBASIC 120; 10; .12; 40.8 mg/170.92mg; mg/170.92mg; mg/170.92mg; mg/170.92mg Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] E 20171231 24839-777_0c51a0bb-4771-40ba-916d-e8c6d8596083 24839-777 HUMAN OTC DRUG BIDEX-400 Guaifenesin TABLET ORAL 20121109 OTC MONOGRAPH FINAL part341 SJ Pharmaceuticals GUAIFENESIN 400 mg/1 E 20171231 24846-0001_2de3432f-0284-4ecf-aa1b-19804f017641 24846-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060926 UNAPPROVED MEDICAL GAS Wilkinson Pharmacy, Inc. OXYGEN 99 L/100L E 20171231 24854-300_54e717a9-f442-48a5-8aac-eee89f00746d 24854-300 HUMAN OTC DRUG retrospect day shield broad spectrum SPF 25 octinoxate, avobenzone, and octocrylene LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part352 Keraplast Technologies LLC OCTINOXATE; AVOBENZONE; OCTOCRYLENE .25; .15; .4 g/50mL; g/50mL; g/50mL E 20171231 24854-400_54e717a9-f442-48a5-8aac-eee89f00746d 24854-400 HUMAN OTC DRUG keras day shield broad spectrum SPF 25 octinoxate, avobenzone, and octocrylene LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part352 Keraplast Technologies LLC OCTINOXATE; AVOBENZONE; OCTOCRYLENE .25; .15; .4 g/50mL; g/50mL; g/50mL E 20171231 24856-002_aefdde09-1562-4bb0-bb6e-d4f61d0c4ecb 24856-002 HUMAN PRESCRIPTION DRUG JETREA ocriplasmin INJECTION, SOLUTION INTRAVITREAL 20170918 BLA BLA125422 ThromboGenics Inc. 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[hp_X]/100g N 20181231 24909-509_4d104246-0241-403d-a5bd-f384ca8e1adf 24909-509 HUMAN OTC DRUG Mom of 11 Kids No Time For Cuts, Scrapes and Burns Calendula OINTMENT TOPICAL 20150810 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC CALENDULA OFFICINALIS FLOWER 6 [hp_X]/100g N 20181231 24909-601_6753533a-2405-444f-9bfa-e10eb5ee47e5 24909-601 HUMAN OTC DRUG Fastrin Anti - Fungal Skin Care Clotrimazole OINTMENT TOPICAL 20170601 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g N 20181231 24909-602_cebb07b2-6a19-4e6e-adda-f2a4bf532226 24909-602 HUMAN OTC DRUG Fastrin Infection Control Skin Repair Benzethonium Chloride OINTMENT TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part333A Aidance Skincare & Topical Solutions, LLC BENZETHONIUM CHLORIDE .2 g/100g N 20181231 24909-603_47fa88a4-4774-4a84-a647-05bbde954fff 24909-603 HUMAN OTC DRUG Fastrin Incontinence and Ostomy Rash Care Calendula, Comfrey, Thuja Occidentalis OINTMENT TOPICAL 20170601 UNAPPROVED HOMEOPATHIC Aidance Skincare & Topical Solutions, LLC CALENDULA OFFICINALIS FLOWER; COMFREY; THUJA OCCIDENTALIS WHOLE 1; 1; 3 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g N 20181231 24909-604_f3139a67-458b-49b3-a139-4111250d5a9d 24909-604 HUMAN OTC DRUG Fastrin Aches and Pain Deep Relief Menthol, Camphor OINTMENT TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC MENTHOL; CAMPHOR (SYNTHETIC) 16; 11 g/100g; g/100g N 20181231 24909-605_38b64015-bb2d-4854-aa9b-44df4cf97517 24909-605 HUMAN OTC DRUG Fastrin Aches and Pain Deep Relief Menthol, Camphor CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC MENTHOL; CAMPHOR (SYNTHETIC) 16; 11 g/100g; g/100g N 20181231 24909-606_4c0f30d8-2d5d-4bde-ad2c-4aae4997f2c0 24909-606 HUMAN OTC DRUG Aspiera Anti-Fungal Clotrimazole OINTMENT TOPICAL 20120531 OTC MONOGRAPH FINAL part333C Aidance Skincare & Topical Solutions, LLC CLOTRIMAZOLE 1 g/100g N 20181231 24909-617_8be668f5-9e77-475e-aacd-7a81eb2fa59b 24909-617 HUMAN OTC DRUG Aspiera Wound Care and Antiseptic Allantoin, Benzethonium Chloride OINTMENT TOPICAL 20120531 OTC MONOGRAPH NOT FINAL part347 Aidance Skincare & Topical Solutions, LLC ALLANTOIN; BENZETHONIUM CHLORIDE .5; .1 g/100g; g/100g N 20181231 24909-618_e57a73f6-5be7-48bc-89b2-d982f5909ef6 24909-618 HUMAN OTC DRUG Aspiera Wound Care and Antiseptic Allantoin, Benzethonium Chloride OINTMENT TOPICAL 20120722 OTC MONOGRAPH NOT FINAL part347 Aidance Skincare & Topical Solutions, LLC ALLANTOIN; BENZETHONIUM CHLORIDE 1; .2 g/100g; g/100g N 20181231 24909-701_d90c89dd-d4d1-4f10-b59e-c8cfed463bcf 24909-701 HUMAN OTC DRUG CBD Clinic - Mild Pain Therapy Lidocaine HCL CREAM TOPICAL 20150716 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC LIDOCAINE HYDROCHLORIDE 4 g/100g N 20181231 24909-702_77287004-8048-45b7-8546-d526940793ce 24909-702 HUMAN OTC DRUG CBD Clinic - Mild To Moderate Muscle and Joint Pain Relief Camphor CREAM TOPICAL 20150716 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC CAMPHOR (SYNTHETIC) 3 g/100g N 20181231 24909-703_1e7a9252-681e-4294-b01e-bb0b245cfc2a 24909-703 HUMAN OTC DRUG CBD Clinic - Moderate Muscle and Joint Pain Relief Menthol CREAM TOPICAL 20150718 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC MENTHOL 4 g/100g N 20181231 24909-704_44f48010-8dd3-43a0-8ab1-0063d1f5a3b1 24909-704 HUMAN OTC DRUG CBD Clinic Deep Muscle and Joint Pain Relief Menthol, Camphor OINTMENT TOPICAL 20150718 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC MENTHOL; CAMPHOR (SYNTHETIC) 7; 5 g/100g; g/100g N 20181231 24909-705_d39708c3-eeb9-4e35-ab50-d72a1c2ffad3 24909-705 HUMAN OTC DRUG CBD Clinic Pro Sport - Deep Muscle and Joint Pain Menthol, Camphor OINTMENT TOPICAL 20150718 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC MENTHOL; CAMPHOR (SYNTHETIC) 16; 11 g/100g; g/100g N 20181231 24909-706_e5eb8d78-748b-4c3f-ba5d-5a21b64bfa6a 24909-706 HUMAN OTC DRUG CBD Clinic Pro Sport - Pain Stick Menthol, Camphor STICK TOPICAL 20171207 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC MENTHOL; CAMPHOR (SYNTHETIC) 16; 11 g/100g; g/100g N 20181231 24909-711_bc2d0b90-f2b6-47f2-82ac-f91cf7759098 24909-711 HUMAN OTC DRUG CBD Clinic - Massage Oil - Level 1 Camphor OIL TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC CAMPHOR (SYNTHETIC) .03 kg/kg N 20181231 24909-712_ccc5232d-7ff0-4440-a896-1fabb239538a 24909-712 HUMAN OTC DRUG CBD Clinic - Massage Oil - Level 2 Menthol OIL TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC MENTHOL .08 kg/kg N 20181231 24909-713_e3aa92d4-1040-435c-a14b-c0633db0b77c 24909-713 HUMAN OTC DRUG CBD Clinic - Massage Oil - Level 3 Camphor, Menthol OIL TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC CAMPHOR (SYNTHETIC); MENTHOL .05; .15 kg/kg; kg/kg N 20181231 24909-721_06a77a91-581f-44de-8b86-29ba8c8393a9 24909-721 HUMAN OTC DRUG CBD Medic - Odor-Free Serious Relief Lidocaine HCL CREAM TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC LIDOCAINE HYDROCHLORIDE 4 g/100g N 20181231 24909-722_9dfd53a9-483b-404c-a7b5-a9ea3b269fc2 24909-722 HUMAN OTC DRUG CBD Medic - Arthritis Deep Relief Camphor, Menthol CREAM TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC CAMPHOR (SYNTHETIC); MENTHOL 10; 10 g/100g; g/100g N 20181231 24909-723_59e25766-0622-48ee-a191-883264960512 24909-723 HUMAN OTC DRUG CBD Medic - Intense Powerful Relief Camphor, Menthol OINTMENT TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC CAMPHOR (SYNTHETIC); MENTHOL 10; 10 g/100g; g/100g N 20181231 24909-724_e9073f5d-436a-42bf-b823-1f90bbf171fd 24909-724 HUMAN OTC DRUG CBD Medic - Active Sport Extreme Relief Camphor, Menthol OINTMENT TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC CAMPHOR (SYNTHETIC); MENTHOL 10; 15 g/100g; g/100g N 20181231 24909-901_3c229ba1-d6c0-48ed-b93a-032e7bcca524 24909-901 HUMAN OTC DRUG H2Ocean Nothing Tattoo Glide And Soothing Balm Lidocaine OINTMENT TOPICAL 20150629 OTC MONOGRAPH NOT FINAL part348 Aidance Skincare & Topical Solutions, LLC LIDOCAINE 4 g/100g N 20181231 24913-2234_c10abd2b-6d2c-4793-a2ce-997419f960f8 24913-2234 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19840601 UNAPPROVED MEDICAL GAS DENISON INC OXYGEN 990 mL/L E 20171231 24959-001_5160be3d-d432-6577-e054-00144ff8d46c 24959-001 HUMAN OTC DRUG Bambo Nature Sunny Day Titanium Dioxide CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part352 DermaPharm A/S TITANIUM DIOXIDE 8.46 g/100g N 20181231 24979-004_b8cfc0ab-db49-42db-a337-f20cb7331e38 24979-004 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, EXTENDED RELEASE ORAL 20150301 ANDA ANDA203104 TWi Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 24979-009_4bb170a3-5ba0-4905-e054-00144ff88e88 24979-009 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 TWI Pharmaceuticals, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 24979-009_72be75d7-c9e9-4af8-ae8e-b12fe80df1d4 24979-009 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 TWi Pharmaceuticals, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 24979-010_4bb170a3-5ba0-4905-e054-00144ff88e88 24979-010 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 TWI Pharmaceuticals, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 24979-010_72be75d7-c9e9-4af8-ae8e-b12fe80df1d4 24979-010 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 TWi Pharmaceuticals, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 24979-011_4bb170a3-5ba0-4905-e054-00144ff88e88 24979-011 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 TWI Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 24979-011_72be75d7-c9e9-4af8-ae8e-b12fe80df1d4 24979-011 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 TWi Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 24979-041_3d131c23-d3fd-5317-e054-00144ff8d46c 24979-041 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20150301 ANDA ANDA203139 TWi Pharmaceuticals, Inc. MEGESTROL ACETATE 125 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 24979-141_bfee3168-9b92-4e23-90a1-772998f43aea 24979-141 HUMAN PRESCRIPTION DRUG Hydroquinone Hydroquinone CREAM TOPICAL 20170616 UNAPPROVED DRUG OTHER TWi Pharmaceuticals, Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 24979-144_82175e2e-4bce-4028-8404-30451274d5e8 24979-144 HUMAN PRESCRIPTION DRUG hydroquinone time release hydroquinone CREAM TOPICAL 20170616 UNAPPROVED DRUG OTHER TWi Pharmaceuticals, Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 24979-533_7faa62a0-1010-4ee6-910c-e2ee0e0575d3 24979-533 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20170707 ANDA ANDA201408 TWi Pharmaceuticals, Inc. GUANFACINE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 24979-534_7faa62a0-1010-4ee6-910c-e2ee0e0575d3 24979-534 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20170707 ANDA ANDA201408 TWi Pharmaceuticals, Inc. GUANFACINE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 24979-536_7faa62a0-1010-4ee6-910c-e2ee0e0575d3 24979-536 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20170707 ANDA ANDA201408 TWi Pharmaceuticals, Inc. GUANFACINE 3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 24979-538_7faa62a0-1010-4ee6-910c-e2ee0e0575d3 24979-538 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20170707 ANDA ANDA201408 TWi Pharmaceuticals, Inc. GUANFACINE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 24987-075_8cfc1663-1dd6-44ec-ab4a-86055f85dfb8 24987-075 HUMAN PRESCRIPTION DRUG Kayexalate sodium polystyrene sulfonate POWDER, FOR SUSPENSION ORAL; RECTAL 20130715 20180630 NDA NDA011287 Covis Pharmaceuticals, Inc. SODIUM POLYSTYRENE SULFONATE 4.1 meq/g E 20171231 24987-242_a61953ed-1ef8-458a-b54b-092022a58613 24987-242 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 20181130 NDA NDA020405 Covis Pharmaceuticals, Inc. DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 24987-249_a61953ed-1ef8-458a-b54b-092022a58613 24987-249 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 20181231 NDA NDA020405 Covis Pharmaceuticals, Inc. DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 24987-260_6fcf9eba-52ef-46f2-8538-f29a37aaaa05 24987-260 HUMAN PRESCRIPTION DRUG LANOXIN digoxin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130215 NDA NDA009330 Covis Pharmaceuticals, Inc. DIGOXIN 250 ug/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 24987-262_6fcf9eba-52ef-46f2-8538-f29a37aaaa05 24987-262 HUMAN PRESCRIPTION DRUG LANOXIN digoxin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130114 NDA NDA009330 Covis Pharmaceuticals, Inc. DIGOXIN 100 ug/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 25000-011_b0149996-6130-40ea-9ccb-0ba3c4be3972 25000-011 HUMAN PRESCRIPTION DRUG Dutasteride Dutasteride CAPSULE, LIQUID FILLED ORAL 20170427 ANDA ANDA204376 MARKSANS PHARMA LIMITED DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 25000-012_d2da21f1-d7f6-43c0-b66f-5b7d14774688 25000-012 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20161231 ANDA ANDA204948 MARKSANS PHARMA LIMITED PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 25000-014_d2da21f1-d7f6-43c0-b66f-5b7d14774688 25000-014 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20161231 ANDA ANDA204948 MARKSANS PHARMA LIMITED PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 25000-017_d2da21f1-d7f6-43c0-b66f-5b7d14774688 25000-017 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20161231 ANDA ANDA204948 MARKSANS PHARMA LIMITED PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 25000-021_c30907f9-1761-41e5-bd4e-2613e756e1c6 25000-021 HUMAN OTC DRUG loratadine loratadine CAPSULE, LIQUID FILLED ORAL 20161001 ANDA ANDA206214 MARKSANS PHARMA LIMITED LORATADINE 10 mg/1 N 20181231 25000-101_85c89e54-772d-4ad2-aab6-6232fc6b2830 25000-101 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160512 ANDA ANDA090295 MARKSANS PHARMA LIMITED METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 25000-102_85c89e54-772d-4ad2-aab6-6232fc6b2830 25000-102 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160512 ANDA ANDA090295 MARKSANS PHARMA LIMITED METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 25000-103_c530b412-5ea8-469f-999d-f6db31717d0b 25000-103 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20110228 ANDA ANDA090007 MARKSANS PHARMA LIMITED GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 25000-104_c530b412-5ea8-469f-999d-f6db31717d0b 25000-104 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20110228 ANDA ANDA090007 MARKSANS PHARMA LIMITED GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 25000-105_c530b412-5ea8-469f-999d-f6db31717d0b 25000-105 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20110228 ANDA ANDA090007 MARKSANS PHARMA LIMITED GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 25000-114_75b1074b-d147-410c-8d3a-160587df01b5 25000-114 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110725 ANDA ANDA091239 MARKSANS PHARMA LIMITED IBUPROFEN 200 mg/1 N 20181231 25000-117_75b1074b-d147-410c-8d3a-160587df01b5 25000-117 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110725 ANDA ANDA091239 MARKSANS PHARMA LIMITED IBUPROFEN 200 mg/1 N 20181231 25000-121_08348e6b-8fcf-484f-8074-f11d23eba5b5 25000-121 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110228 ANDA ANDA090796 MARKSANS PHARMA LIMITED IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 25000-122_08348e6b-8fcf-484f-8074-f11d23eba5b5 25000-122 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110228 ANDA ANDA090796 MARKSANS PHARMA LIMITED IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 25000-123_08348e6b-8fcf-484f-8074-f11d23eba5b5 25000-123 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20110228 ANDA ANDA090796 MARKSANS PHARMA LIMITED IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 25000-131_c19bb10f-9fe4-4204-8bd6-3a6fc6622b7e 25000-131 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120601 ANDA ANDA090888 MARKSANS PHARMA LIMITED METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 25000-132_c19bb10f-9fe4-4204-8bd6-3a6fc6622b7e 25000-132 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120601 ANDA ANDA090888 MARKSANS PHARMA LIMITED METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 25000-133_06a544aa-d0db-473c-9a78-5b6d416d707c 25000-133 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170901 ANDA ANDA079205 MARKSANS PHARMA LIMITED IBUPROFEN 200 mg/1 N 20181231 25000-134_c19bb10f-9fe4-4204-8bd6-3a6fc6622b7e 25000-134 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120601 ANDA ANDA090888 MARKSANS PHARMA LIMITED METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 25000-135_fbd36eab-a89e-4d49-885b-e24c16f36b17 25000-135 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20151106 ANDA ANDA091237 MARKSANS PHARMA LIMITED IBUPROFEN 200 mg/1 N 20181231 25000-136_fbd36eab-a89e-4d49-885b-e24c16f36b17 25000-136 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20151106 ANDA ANDA091237 MARKSANS PHARMA LIMITED IBUPROFEN 200 mg/1 N 20181231 25000-138_9d471972-f266-4d08-9b80-2eefe17d3a54 25000-138 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110228 ANDA ANDA091416 MARKSANS PHARMA LIMITED NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 25000-139_9d471972-f266-4d08-9b80-2eefe17d3a54 25000-139 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110228 ANDA ANDA091416 MARKSANS PHARMA LIMITED NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 25000-140_9d471972-f266-4d08-9b80-2eefe17d3a54 25000-140 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20110228 ANDA ANDA091416 MARKSANS PHARMA LIMITED NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 25000-141_90fbd820-8fd1-44cf-a744-a895cde3fb51 25000-141 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium, Coated Tablets TABLET ORAL 20110528 ANDA ANDA090545 MARKSANS PHARMA LIMITED NAPROXEN SODIUM 220 mg/1 N 20181231 25000-144_90fbd820-8fd1-44cf-a744-a895cde3fb51 25000-144 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium Tablet, coated TABLET ORAL 20110504 ANDA ANDA090545 MARKSANS PHARMA LIMITED NAPROXEN SODIUM 220 mg/1 N 20181231 25010-210_4b41bd4b-fe8e-4f75-b883-60e38808e2d5 25010-210 HUMAN PRESCRIPTION DRUG Sodium Edecrin ethacrynate sodium POWDER, FOR SOLUTION INTRAVENOUS 19670110 NDA NDA016093 Aton Pharma, Inc. ETHACRYNATE SODIUM 50 mg/50mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 25010-215_99393879-0ec5-4beb-bc89-cb4af1c33852 25010-215 HUMAN PRESCRIPTION DRUG EDECRIN ethacrynic acid TABLET ORAL 19670110 NDA NDA016092 Aton Pharma, Inc. ETHACRYNIC ACID 25 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 25010-305_00baa448-ed18-4e30-80f5-77b5695e98b7 25010-305 HUMAN PRESCRIPTION DRUG Demser metyrosine CAPSULE ORAL 19791003 NDA NDA017871 Aton Pharma, Inc. METYROSINE 250 mg/1 Catecholamine Synthesis Inhibitor [EPC],Catecholamine Synthesis Inhibitors [MoA] N 20181231 25010-705_ab9e4ced-8667-4755-8af9-41597daa082c 25010-705 HUMAN PRESCRIPTION DRUG Cuprimine Penicillamine CAPSULE ORAL 19701204 NDA NDA019853 Aton Pharma, Inc. PENICILLAMINE 250 mg/1 Antirheumatic Agent [EPC] N 20181231 25010-711_218678a3-a7fd-46ac-92a7-9d0dd870ed54 25010-711 HUMAN PRESCRIPTION DRUG Lodosyn carbidopa TABLET ORAL 20100413 NDA NDA017830 Aton Pharma, Inc CARBIDOPA 25 mg/1 N 20181231 25010-812_2da4053f-96c8-4e40-ad53-c925447ce882 25010-812 HUMAN PRESCRIPTION DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC 19780817 NDA NDA018086 Aton Pharma, Inc. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 25010-813_2da4053f-96c8-4e40-ad53-c925447ce882 25010-813 HUMAN PRESCRIPTION DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC 19780817 NDA NDA018086 Aton Pharma, Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 25010-814_0f32f82b-4e6e-4958-9124-f97451ae3e20 25010-814 HUMAN PRESCRIPTION DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC 19861105 NDA NDA019463 Aton Pharma, Inc. TIMOLOL MALEATE 2.5 mg/mL N 20181231 25010-815_0f32f82b-4e6e-4958-9124-f97451ae3e20 25010-815 HUMAN PRESCRIPTION DRUG Timoptic Timolol Maleate SOLUTION OPHTHALMIC 19861105 NDA NDA019463 Aton Pharma, Inc. TIMOLOL MALEATE 5 mg/mL N 20181231 25021-100_55a6dfac-0fb1-4e64-8e69-ceb5e0c935f6 25021-100 HUMAN PRESCRIPTION DRUG cefazolin cefazolin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090201 ANDA ANDA065303 Sagent Pharmaceuticals CEFAZOLIN SODIUM 500 mg/2.2mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-100_d6c6b222-2caf-4aaa-b947-ff84885cd11f 25021-100 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150701 ANDA ANDA065303 Sagent Pharmaceuticals CEFAZOLIN SODIUM 500 mg/2.2mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-101_55a6dfac-0fb1-4e64-8e69-ceb5e0c935f6 25021-101 HUMAN PRESCRIPTION DRUG cefazolin cefazolin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090201 ANDA ANDA065303 Sagent Pharmaceuticals CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-101_d6c6b222-2caf-4aaa-b947-ff84885cd11f 25021-101 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150701 ANDA ANDA065303 Sagent Pharmaceuticals CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-102_71f62dd3-8c97-4e5f-9657-0811e8a36da6 25021-102 HUMAN PRESCRIPTION DRUG Cefazolin cefazolin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20150701 ANDA ANDA065306 Sagent Pharmaceuticals CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-102_88b68d32-a271-4bd0-b080-355a7b0cd4e2 25021-102 HUMAN PRESCRIPTION DRUG Cefazolin cefazolin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090401 ANDA ANDA065306 Sagent Pharmaceuticals CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-105_94751053-3c9f-4cae-869f-d170d3f9b1a6 25021-105 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150701 ANDA ANDA065329 Sagent Pharmaceuticals CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-105_b7225e90-94cc-4b16-b579-5028d343a644 25021-105 HUMAN PRESCRIPTION DRUG ceftriaxone ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091105 ANDA ANDA065329 Sagent Pharmaceuticals CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-106_94751053-3c9f-4cae-869f-d170d3f9b1a6 25021-106 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150701 ANDA ANDA065329 Sagent Pharmaceuticals CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-106_b7225e90-94cc-4b16-b579-5028d343a644 25021-106 HUMAN PRESCRIPTION DRUG ceftriaxone ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091105 ANDA ANDA065329 Sagent Pharmaceuticals CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-107_94751053-3c9f-4cae-869f-d170d3f9b1a6 25021-107 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150701 ANDA ANDA065329 Sagent Pharmaceuticals CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-107_b7225e90-94cc-4b16-b579-5028d343a644 25021-107 HUMAN PRESCRIPTION DRUG ceftriaxone ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091105 ANDA ANDA065329 Sagent Pharmaceuticals CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-108_06fe06d5-4cdc-48bf-8132-e07fa16800f0 25021-108 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091105 ANDA ANDA065328 Sagent Pharmaceuticals CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-108_8a4b8797-466d-43dc-87c2-ff9f9949fb9f 25021-108 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20150701 ANDA ANDA065328 Sagent Pharmaceuticals CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-109_3b4a705a-34ef-4418-ab86-98ba246224cd 25021-109 HUMAN PRESCRIPTION DRUG Cefoxitin cefoxitin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091105 ANDA ANDA065414 Sagent Pharmaceuticals CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-110_3b4a705a-34ef-4418-ab86-98ba246224cd 25021-110 HUMAN PRESCRIPTION DRUG Cefoxitin cefoxitin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091105 ANDA ANDA065414 Sagent Pharmaceuticals CEFOXITIN SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-111_bcab9840-e07f-4630-9f4a-39f71a7db5e4 25021-111 HUMAN PRESCRIPTION DRUG Cefoxitin cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100812 ANDA ANDA065415 Sagent Pharmaceuticals CEFOXITIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-112_6bf91e95-234b-49da-9cf0-eefef45a1574 25021-112 HUMAN PRESCRIPTION DRUG Azithromycin azithromycin monohydrate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090501 ANDA ANDA065506 Sagent Pharmaceuticals AZITHROMYCIN MONOHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 25021-113_fd52a4da-d9eb-4ef9-bc18-8168fd0ba6f0 25021-113 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION, SOLUTION INTRAVENOUS 20090901 ANDA ANDA079104 Sagent Pharmaceuticals FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 25021-114_191c5f79-5b62-4d93-9a21-efe884ab1d45 25021-114 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20080324 ANDA ANDA078252 Sagent Pharmaceuticals CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 25021-115_661285f7-2782-4389-89b1-f10568958d53 25021-115 HUMAN PRESCRIPTION DRUG Clindamycin Clindamycin Phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120515 ANDA ANDA090108 Sagent Pharmaceuticals CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 25021-115_dfe33479-23cd-4005-a777-be8bd1a4b26e 25021-115 HUMAN PRESCRIPTION DRUG Clindamycin clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 20120515 ANDA ANDA090109 Sagent Pharmaceuticals CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 25021-116_122bae6c-afe4-4992-a915-e3c6490b0f29 25021-116 HUMAN PRESCRIPTION DRUG Bacitracin bacitracin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20100810 ANDA ANDA090211 Sagent Pharmaceuticals BACITRACIN 50000 [iU]/10mL Decreased Cell Wall Synthesis & Repair [PE] N 20181231 25021-118_480790e6-ea62-423e-964d-cfa4e8541c00 25021-118 HUMAN PRESCRIPTION DRUG Cefuroxime Sodium Cefuroxime Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160901 ANDA ANDA064125 Sagent Pharmaceuticals CEFUROXIME SODIUM 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-119_480790e6-ea62-423e-964d-cfa4e8541c00 25021-119 HUMAN PRESCRIPTION DRUG Cefuroxime Sodium Cefuroxime Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160901 ANDA ANDA064125 Sagent Pharmaceuticals CEFUROXIME SODIUM 1.5 g/16mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-121_1013fa85-dc62-4f70-aca6-26c50d7ea9bd 25021-121 HUMAN PRESCRIPTION DRUG cefepime cefepime hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150701 ANDA ANDA065441 Sagent Pharmaceuticals CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-121_40b4deba-2c5c-4c76-a905-4d803eaadea4 25021-121 HUMAN PRESCRIPTION DRUG cefepime cefepime hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080501 ANDA ANDA065441 Sagent Pharmaceuticals CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-122_1013fa85-dc62-4f70-aca6-26c50d7ea9bd 25021-122 HUMAN PRESCRIPTION DRUG cefepime cefepime hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20150701 ANDA ANDA065441 Sagent Pharmaceuticals CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-122_40b4deba-2c5c-4c76-a905-4d803eaadea4 25021-122 HUMAN PRESCRIPTION DRUG cefepime cefepime hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080501 ANDA ANDA065441 Sagent Pharmaceuticals CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-127_55a9adcf-c0fe-489d-88af-eac7e4fb304d 25021-127 HUMAN PRESCRIPTION DRUG Ceftazidime ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080515 ANDA ANDA062640 Sagent Pharmaceuticals CEFTAZIDIME 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 25021-127_731472b1-5df9-4c15-b031-c7e2794ad9c9 25021-127 HUMAN PRESCRIPTION DRUG Ceftazidime ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150701 ANDA ANDA062640 Sagent Pharmaceuticals CEFTAZIDIME 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 25021-128_55a9adcf-c0fe-489d-88af-eac7e4fb304d 25021-128 HUMAN PRESCRIPTION DRUG Ceftazidime ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080515 ANDA ANDA062640 Sagent Pharmaceuticals CEFTAZIDIME 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 25021-128_731472b1-5df9-4c15-b031-c7e2794ad9c9 25021-128 HUMAN PRESCRIPTION DRUG Ceftazidime ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20150701 ANDA ANDA062640 Sagent Pharmaceuticals CEFTAZIDIME 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 25021-129_372da52d-1554-453b-92db-fd5f479e6855 25021-129 HUMAN PRESCRIPTION DRUG Ceftazidime ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080515 ANDA ANDA062640 Sagent Pharmaceuticals CEFTAZIDIME 6 g/30mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-129_5ff1b7e7-ad99-49e3-b2e6-3b3943d9b6d2 25021-129 HUMAN PRESCRIPTION DRUG Ceftazidime ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20150701 ANDA ANDA062640 Sagent Pharmaceuticals CEFTAZIDIME 6 g/30mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-130_4f84c512-9943-4f5d-ab91-a3522cb544c6 25021-130 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20120105 ANDA ANDA200560 Sagent Pharmaceuticals LEVOFLOXACIN 25 mg/mL N 20181231 25021-132_27ba5f96-83b3-4251-b159-9bbe655356e1 25021-132 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20110620 ANDA ANDA090343 Sagent Pharmaceuticals LEVOFLOXACIN 5 mg/mL N 20181231 25021-132_dc52c6d8-20be-4424-9fd1-0faa51a28b39 25021-132 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20130715 ANDA ANDA090343 Sagent Pharmaceuticals LEVOFLOXACIN 5 mg/mL N 20181231 25021-134_d983331f-8c58-421f-b35e-a13f713e4556 25021-134 HUMAN PRESCRIPTION DRUG ampicillin ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140701 ANDA ANDA090354 Sagent Pharmaceuticals AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-135_d983331f-8c58-421f-b35e-a13f713e4556 25021-135 HUMAN PRESCRIPTION DRUG ampicillin ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140701 ANDA ANDA090354 Sagent Pharmaceuticals AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-136_d983331f-8c58-421f-b35e-a13f713e4556 25021-136 HUMAN PRESCRIPTION DRUG ampicillin ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140701 ANDA ANDA090354 Sagent Pharmaceuticals AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-137_d983331f-8c58-421f-b35e-a13f713e4556 25021-137 HUMAN PRESCRIPTION DRUG ampicillin ampicillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140701 ANDA ANDA090354 Sagent Pharmaceuticals AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-138_1869a3f7-3f12-466c-96e9-2a9eef7bad58 25021-138 HUMAN PRESCRIPTION DRUG ampicillin ampicillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100707 ANDA ANDA063142 Sagent Pharmaceuticals AMPICILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-139_819f25b9-b779-4c4d-85f6-977543136d25 25021-139 HUMAN PRESCRIPTION DRUG Nafcillin nafcillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121025 ANDA ANDA090582 Sagent Pharmaceuticals NAFCILLIN SODIUM 1 g/4mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-140_819f25b9-b779-4c4d-85f6-977543136d25 25021-140 HUMAN PRESCRIPTION DRUG Nafcillin nafcillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121025 ANDA ANDA090582 Sagent Pharmaceuticals NAFCILLIN SODIUM 2 g/8mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-141_4081117d-5c1b-4d25-bd24-32a504a28255 25021-141 HUMAN PRESCRIPTION DRUG Nafcillin nafcillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121025 ANDA ANDA090580 Sagent Pharmaceuticals NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-142_43658dc8-ff0d-45ae-aeee-8bfc30411d56 25021-142 HUMAN PRESCRIPTION DRUG ampicillin and sulbactam ampicillin and sulbactam INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100630 ANDA ANDA065406 Sagent Pharmaceuticals AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20191231 25021-143_43658dc8-ff0d-45ae-aeee-8bfc30411d56 25021-143 HUMAN PRESCRIPTION DRUG ampicillin and sulbactam ampicillin and sulbactam INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100630 ANDA ANDA065406 Sagent Pharmaceuticals AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20191231 25021-144_3199f626-116c-4792-b336-8451795c600d 25021-144 HUMAN PRESCRIPTION DRUG ampicillin and sulbactam ampicillin and sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100812 ANDA ANDA065403 Sagent Pharmaceuticals AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20191231 25021-146_41a3d287-1c42-4887-b84c-280d75f2117b 25021-146 HUMAN PRESCRIPTION DRUG Oxacillin oxacillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120601 ANDA ANDA091246 Sagent Pharmaceuticals OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-146_80d55789-735a-44dc-be41-de93e3293ef1 25021-146 HUMAN PRESCRIPTION DRUG Oxacillin oxacillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140615 ANDA ANDA091246 Sagent Pharmaceuticals OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-155_adb5e0f0-cdc2-41eb-998c-7bc2e146fa26 25021-155 HUMAN PRESCRIPTION DRUG Meropenem meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170115 ANDA ANDA204854 Sagent Pharmaceuticals MEROPENEM 500 mg/1 Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 25021-156_adb5e0f0-cdc2-41eb-998c-7bc2e146fa26 25021-156 HUMAN PRESCRIPTION DRUG Meropenem meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170115 ANDA ANDA204854 Sagent Pharmaceuticals MEROPENEM 1 g/1 Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 25021-157_88d897cb-ab1c-46de-b00a-5090d2a02cba 25021-157 HUMAN PRESCRIPTION DRUG Vancomycin vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120920 ANDA ANDA200837 Sagent Pharmaceuticals VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 25021-158_88d897cb-ab1c-46de-b00a-5090d2a02cba 25021-158 HUMAN PRESCRIPTION DRUG Vancomycin vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120920 ANDA ANDA200837 Sagent Pharmaceuticals VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 25021-159_a92060c3-aed5-499c-9639-42e819bc36d5 25021-159 HUMAN PRESCRIPTION DRUG Colistimethate colistimethate sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141229 ANDA ANDA201365 Sagent Pharmaceuticals COLISTIMETHATE SODIUM 150 mg/2mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 25021-162_41a3d287-1c42-4887-b84c-280d75f2117b 25021-162 HUMAN PRESCRIPTION DRUG Oxacillin oxacillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120601 ANDA ANDA091246 Sagent Pharmaceuticals OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-162_80d55789-735a-44dc-be41-de93e3293ef1 25021-162 HUMAN PRESCRIPTION DRUG Oxacillin oxacillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140615 ANDA ANDA091246 Sagent Pharmaceuticals OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-163_137978fb-a614-4c7b-b621-903a95f3a13e 25021-163 HUMAN PRESCRIPTION DRUG Oxacillin oxacillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140615 ANDA ANDA091245 Sagent Pharmaceuticals OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-163_c2d7f256-a958-48f9-8c3b-55e7462a2a7a 25021-163 HUMAN PRESCRIPTION DRUG Oxacillin oxacillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120601 ANDA ANDA091245 Sagent Pharmaceuticals OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 25021-164_dda4715a-3c11-4afa-aeba-d69c03a20452 25021-164 HUMAN PRESCRIPTION DRUG Piperacillin, Tazobactam Piperacillin Sodium, Tazobactam Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110616 ANDA ANDA065498 Sagent Pharmaceuticals PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 25021-165_dda4715a-3c11-4afa-aeba-d69c03a20452 25021-165 HUMAN PRESCRIPTION DRUG Piperacillin, Tazobactam Piperacillin Sodium, Tazobactam Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110616 ANDA ANDA065498 Sagent Pharmaceuticals PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 25021-166_dda4715a-3c11-4afa-aeba-d69c03a20452 25021-166 HUMAN PRESCRIPTION DRUG Piperacillin, Tazobactam Piperacillin Sodium, Tazobactam Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110616 ANDA ANDA065498 Sagent Pharmaceuticals PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 25021-169_a304dd8f-8c97-4ccb-9c46-0dc449f12d58 25021-169 HUMAN PRESCRIPTION DRUG linezolid linezolid INJECTION, SOLUTION INTRAVENOUS 20170815 ANDA ANDA204696 Sagent Pharmaceuticals LINEZOLID 2 mg/mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 25021-173_d77363c1-1f06-4ec3-ab2a-0b7b52d4ad24 25021-173 HUMAN PRESCRIPTION DRUG amikacin sulfate amikacin sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160615 ANDA ANDA203323 Sagent Pharmaceuticals AMIKACIN SULFATE 250 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 25021-179_d6931279-87f3-4a5d-a417-720f5fc1cbfb 25021-179 HUMAN PRESCRIPTION DRUG Daptomycin Daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20180115 NDA NDA208385 Sagent Pharmaceuticals DAPTOMYCIN 350 mg/7mL Lipopeptide Antibacterial [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 25021-182_b21fb0d8-aa73-4ca1-9a72-354a527c5c6f 25021-182 HUMAN PRESCRIPTION DRUG Cefuroxime Sodium Cefuroxime Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160901 ANDA ANDA064125 Sagent Pharmaceuticals CEFUROXIME SODIUM 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-183_b21fb0d8-aa73-4ca1-9a72-354a527c5c6f 25021-183 HUMAN PRESCRIPTION DRUG Cefuroxime Sodium Cefuroxime Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160901 ANDA ANDA064125 Sagent Pharmaceuticals CEFUROXIME SODIUM 1.5 g/16mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 25021-186_d38a0201-b95d-4e80-84f6-29e9877e1bd5 25021-186 HUMAN PRESCRIPTION DRUG ampicillin and sulbactam ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170815 ANDA ANDA090579 Sagent Pharmaceuticals AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 25021-187_d38a0201-b95d-4e80-84f6-29e9877e1bd5 25021-187 HUMAN PRESCRIPTION DRUG ampicillin and sulbactam ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170815 ANDA ANDA090579 Sagent Pharmaceuticals AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 25021-188_8ffa9cb7-7976-46c7-8b3a-75d6d7e45ca4 25021-188 HUMAN PRESCRIPTION DRUG ampicillin and sulbactam ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170815 ANDA ANDA090578 Sagent Pharmaceuticals AMPICILLIN SODIUM; SULBACTAM SODIUM 10; 5 g/100mL; g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 25021-201_a6f2746f-6f3b-435b-bb6b-ec3934624e0e 25021-201 HUMAN PRESCRIPTION DRUG Mesna mesna INJECTION, SOLUTION INTRAVENOUS 20130430 ANDA ANDA090913 Sagent Pharmaceuticals MESNA 100 mg/mL Cytoprotective Agent [EPC] N 20181231 25021-201_d258c8dc-6cd9-4e5d-b24b-8a7f694a4f16 25021-201 HUMAN PRESCRIPTION DRUG Mesna mesna INJECTION, SOLUTION INTRAVENOUS 20101201 ANDA ANDA090913 Sagent Pharmaceuticals MESNA 100 mg/mL Cytoprotective Agent [EPC] N 20181231 25021-201_f43d6f77-8b14-44e0-9776-899373ad5d71 25021-201 HUMAN PRESCRIPTION DRUG mesna mesna INJECTION, SOLUTION INTRAVENOUS 20130430 ANDA ANDA090913 Sagent Pharmaceuticals MESNA 100 mg/mL Cytoprotective Agent [EPC] N 20181231 25021-202_af5fe760-3fad-45d8-9a20-5864215d19d8 25021-202 HUMAN PRESCRIPTION DRUG Carboplatin carboplatin INJECTION, SOLUTION INTRAVENOUS 20131031 ANDA ANDA077096 Sagent Pharmaceuticals CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 25021-203_8b4d4db3-8a78-4b4f-a5c3-bacb101395a0 25021-203 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride epirubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140831 ANDA ANDA065361 Sagent Pharmaceuticals EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 25021-204_753fafca-59aa-454d-979e-9f7feec3bc7a 25021-204 HUMAN PRESCRIPTION DRUG Vinorelbine Vinorelbine INJECTION, SOLUTION INTRAVENOUS 20140915 ANDA ANDA091106 Sagent Pharmaceuticals VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] N 20181231 25021-205_8a25164b-70d9-4160-9b1e-2b665d405587 25021-205 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090201 ANDA ANDA078610 Sagent Pharmaceuticals FLUDARABINE PHOSPHATE 50 mg/2mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 25021-206_cb8783c7-432e-4615-a52b-b0769bb62e00 25021-206 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride topotecan hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20101128 ANDA ANDA091284 Sagent Pharmaceuticals TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 25021-207_7b73261a-2590-441c-bff1-2d08972ee3d4 25021-207 HUMAN PRESCRIPTION DRUG doxorubicin hydrochloride doxorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20131031 ANDA ANDA091495 Sagent Pharmaceuticals DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 25021-213_3473cc55-601b-4925-8cf5-06f1835f9ede 25021-213 HUMAN PRESCRIPTION DRUG Paclitaxel paclitaxel INJECTION, SOLUTION INTRAVENOUS 20110927 ANDA ANDA090130 Sagent Pharmaceuticals PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 25021-215_2fcef624-1d6a-43ad-873b-495048cfc763 25021-215 HUMAN PRESCRIPTION DRUG fluorouracil fluorouracil INJECTION, SOLUTION INTRAVENOUS 20160915 ANDA ANDA203609 Sagent Pharmaceuticals FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 25021-221_777c4ef1-94ff-4a4a-9d58-6b7c090ad756 25021-221 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride KIT INTRAVENOUS 20170315 ANDA ANDA201379 Sagent Pharmaceuticals N 20181231 25021-230_f3029076-6f11-41e6-9ef7-13e511426269 25021-230 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride irinotecan hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140815 ANDA ANDA090675 Sagent Pharmaceuticals IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 25021-233_03e8182d-05ab-495c-a20a-93a28c89b461 25021-233 HUMAN PRESCRIPTION DRUG oxaliplatin oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20140915 ANDA ANDA203869 Sagent Pharmaceuticals OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 25021-234_c1495a10-e662-4e01-8e12-10c45d989ba3 25021-234 HUMAN PRESCRIPTION DRUG gemcitabine gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141229 ANDA ANDA202485 Sagent Pharmaceuticals GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 25021-235_c1495a10-e662-4e01-8e12-10c45d989ba3 25021-235 HUMAN PRESCRIPTION DRUG gemcitabine gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141229 ANDA ANDA202485 Sagent Pharmaceuticals GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 25021-236_0d9ddc95-c952-4822-9bbe-51edc6023f6b 25021-236 HUMAN PRESCRIPTION DRUG topotecan topotecan INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20141215 NDA NDA022453 Sagent Pharmaceuticals TOPOTECAN HYDROCHLORIDE 1 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 25021-237_e2a4aec7-7ba5-4200-a1fe-77904e671ac8 25021-237 HUMAN PRESCRIPTION DRUG fludarabine phosphate fludarabine phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141215 ANDA ANDA076349 Sagent Pharmaceuticals FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 25021-241_fb195d4c-7f7e-442a-b9b6-a51cc7796e00 25021-241 HUMAN PRESCRIPTION DRUG Busulfan Busulfan INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170515 ANDA ANDA207050 Sagent Pharmaceuticals BUSULFAN 6 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 25021-242_7ef2f8ce-c10d-404e-b532-b3f91a4abcd5 25021-242 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION, SOLUTION INTRAVENOUS 20161015 ANDA ANDA076661 Sagent Pharmaceuticals FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 25021-245_b504a8c4-0bcd-42ba-9794-ea0c11b001a1 25021-245 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel Anhydrous INJECTION, SOLUTION INTRAVENOUS 20170915 ANDA ANDA207252 Sagent Pharmaceuticals DOCETAXEL ANHYDROUS 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 25021-246_a3ae11de-edf2-4750-bb92-efd6ae81af70 25021-246 HUMAN PRESCRIPTION DRUG Thiotepa Thiotepa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVITARY; INTRAVENOUS; INTRAVESICAL 20170815 ANDA ANDA209150 Sagent Pharmaceuticals THIOTEPA 15 mg/1.5mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 25021-301_39e660e2-7d39-46c3-804e-5138504cc78a 25021-301 HUMAN PRESCRIPTION DRUG adenosine adenosine INJECTION INTRAVENOUS 20090901 ANDA ANDA078686 Sagent Pharmaceuticals ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 25021-301_4bc1196f-288a-42ee-a47b-465c23f607e5 25021-301 HUMAN PRESCRIPTION DRUG adenosine adenosine INJECTION INTRAVENOUS 20140416 ANDA ANDA077283 Sagent Pharmaceuticals ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 25021-302_95a039ad-5a5f-4851-a5b1-ad6e7e905dd6 25021-302 HUMAN PRESCRIPTION DRUG amiodarone hydrochloride amiodarone hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130715 ANDA ANDA077161 Sagent Pharmaceuticals AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 25021-303_eba58ea6-8964-4bcd-8d97-6049accb888b 25021-303 HUMAN PRESCRIPTION DRUG Metoprolol Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20100510 ANDA ANDA090317 Sagent Pharmaceuticals METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 25021-305_b3297614-fada-4119-86c9-8701a446f6c1 25021-305 HUMAN PRESCRIPTION DRUG chlorothiazide sodium chlorothiazide sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20151012 ANDA ANDA202462 Sagent Pharmaceuticals CHLOROTHIAZIDE SODIUM 500 mg/18mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 25021-307_26ece824-04e8-443e-975c-7f2415c15a44 25021-307 HUMAN PRESCRIPTION DRUG Adenosine adenosine INJECTION, SOLUTION INTRAVENOUS 20140328 ANDA ANDA090212 Sagent Pharmaceuticals ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 25021-307_8b94e1a6-8963-40ff-ad8c-e85ba9235a61 25021-307 HUMAN PRESCRIPTION DRUG Adenosine adenosine INJECTION, SOLUTION INTRAVENOUS 20150901 ANDA ANDA090212 Sagent Pharmaceuticals ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 25021-310_184506f8-f0c2-4c67-b7a2-3125e98201d5 25021-310 HUMAN PRESCRIPTION DRUG Sodium Nitroprusside Sodium Nitroprusside INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20171201 ANDA ANDA207426 Sagent Pharmaceuticals SODIUM NITROPRUSSIDE 25 mg/mL Vasodilation [PE],Vasodilator [EPC] N 20181231 25021-310_d500db35-05f1-4f03-aeb4-b3b04ef4e300 25021-310 HUMAN PRESCRIPTION DRUG Sodium Nitroprusside Sodium Nitroprusside INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20161006 ANDA ANDA207426 Sagent Pharmaceuticals SODIUM NITROPRUSSIDE 25 mg/mL Vasodilation [PE],Vasodilator [EPC] N 20181231 25021-400_56aa303e-9f98-4704-96dc-8863fe5d16d9 25021-400 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140701 ANDA ANDA090808 Sagent Pharmaceticals HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 25021-400_5e78e6b5-8d1c-47c1-aab1-e2fb4eb92ecb 25021-400 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090808 Sagent Pharmaceuticals HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 25021-401_0f2b71dd-89e9-49f4-8626-1a9b99f43bf0 25021-401 HUMAN PRESCRIPTION DRUG Heparin Sodium heparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090810 Sagent Pharmaceticals HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 25021-402_56aa303e-9f98-4704-96dc-8863fe5d16d9 25021-402 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140701 ANDA ANDA090808 Sagent Pharmaceticals HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 25021-402_5e78e6b5-8d1c-47c1-aab1-e2fb4eb92ecb 25021-402 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090808 Sagent Pharmaceuticals HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 25021-403_56aa303e-9f98-4704-96dc-8863fe5d16d9 25021-403 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140701 ANDA ANDA090808 Sagent Pharmaceticals HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 25021-403_5e78e6b5-8d1c-47c1-aab1-e2fb4eb92ecb 25021-403 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090808 Sagent Pharmaceuticals HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 25021-404_fddd1511-2326-4ae6-8818-a41c2e52c89b 25021-404 HUMAN PRESCRIPTION DRUG Heparin Sodium heparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090809 Sagent Pharmaceuticals HEPARIN SODIUM 20000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 25021-405_2f5bb80b-2561-483f-afa2-0acaeb30c28d 25021-405 HUMAN PRESCRIPTION DRUG bivalirudin bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20161001 ANDA ANDA091602 Sagent Pharmaceuticals BIVALIRUDIN 250 mg/1 Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 25021-451_795b1b20-6336-4360-89f7-7d4e4bc1514b 25021-451 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20131215 ANDA ANDA090834 Sagent Pharmaceuticals OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 25021-452_795b1b20-6336-4360-89f7-7d4e4bc1514b 25021-452 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20131215 ANDA ANDA090834 Sagent Pharmaceuticals OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 25021-453_795b1b20-6336-4360-89f7-7d4e4bc1514b 25021-453 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20131215 ANDA ANDA090834 Sagent Pharmaceuticals OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 25021-454_795b1b20-6336-4360-89f7-7d4e4bc1514b 25021-454 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20131215 ANDA ANDA091041 Sagent Pharmaceuticals OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 25021-455_795b1b20-6336-4360-89f7-7d4e4bc1514b 25021-455 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20131215 ANDA ANDA091041 Sagent Pharmaceuticals OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20191231 25021-600_a7ca6c68-27d6-4be2-8850-3513160b5c38 25021-600 HUMAN PRESCRIPTION DRUG Flumazenil flumazenil INJECTION, SOLUTION INTRAVENOUS 20120915 ANDA ANDA090584 Sagent Pharmaceuticals FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 25021-601_b5d3e50c-a55e-49b7-8333-80aa15a181c8 25021-601 HUMAN PRESCRIPTION DRUG caffeine citrate caffeine citrate SOLUTION INTRAVENOUS 20120915 ANDA ANDA090827 Sagent Pharmaceuticals CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 25021-602_b5d3e50c-a55e-49b7-8333-80aa15a181c8 25021-602 HUMAN PRESCRIPTION DRUG caffeine citrate caffeine citrate SOLUTION ORAL 20120915 ANDA ANDA091102 Sagent Pharmaceuticals CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 25021-608_ce151e10-a6fb-4322-ad3a-64f1334b4675 25021-608 HUMAN PRESCRIPTION DRUG propofol propofol INJECTION, EMULSION INTRAVENOUS 20140701 ANDA ANDA075102 Sagent Pharmaceuticals PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 25021-651_fa0fec7b-94eb-4352-bd31-40c3a3e2dfd2 25021-651 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate orphenadrine citrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111001 ANDA ANDA090585 Sagent Pharmaceuticals ORPHENADRINE CITRATE 30 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 25021-652_3ea57cba-ac27-4721-880d-79949a271bf6 25021-652 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ropivacaine hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20140923 ANDA ANDA090318 Sagent Pharmaceuticals ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 25021-653_3ea57cba-ac27-4721-880d-79949a271bf6 25021-653 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ropivacaine hydrochloride INJECTION, SOLUTION EPIDURAL 20140923 ANDA ANDA090318 Sagent Pharmaceuticals ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 25021-654_3ea57cba-ac27-4721-880d-79949a271bf6 25021-654 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ropivacaine hydrochloride INJECTION, SOLUTION EPIDURAL; PERINEURAL 20140923 ANDA ANDA090318 Sagent Pharmaceuticals ROPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 25021-655_b9306ba7-0a2c-4666-87fb-d76e74d30b3b 25021-655 HUMAN PRESCRIPTION DRUG Midazolam midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120319 ANDA ANDA090315 Sagent Pharmaceuticals MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 25021-656_b9306ba7-0a2c-4666-87fb-d76e74d30b3b 25021-656 HUMAN PRESCRIPTION DRUG Midazolam midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120319 ANDA ANDA090315 Sagent Pharmaceuticals MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 25021-657_97234f4c-7033-4a5b-bf1c-6db579cd37bf 25021-657 HUMAN PRESCRIPTION DRUG Vecuronium vecuronium bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110801 ANDA ANDA078274 Sagent Pharmaceuticals VECURONIUM BROMIDE 10 mg/10mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 25021-658_97234f4c-7033-4a5b-bf1c-6db579cd37bf 25021-658 HUMAN PRESCRIPTION DRUG Vecuronium vecuronium bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110801 ANDA ANDA078274 Sagent Pharmaceuticals VECURONIUM BROMIDE 20 mg/20mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 25021-659_2499d6bc-6ece-44f3-b8d7-f68b6d705fd8 25021-659 HUMAN PRESCRIPTION DRUG Atracurium Besylate atracurium besylate INJECTION, SOLUTION INTRAVENOUS 20150731 ANDA ANDA091488 Sagent Pharmaceuticals ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 25021-659_82c1ea14-68eb-4de7-b7aa-9908fa4fbaf6 25021-659 HUMAN PRESCRIPTION DRUG Atracurium Besylate atracurium besylate INJECTION, SOLUTION INTRAVENOUS 20150731 ANDA ANDA091488 Sagent Pharmaceuticals ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 25021-659_b147336d-cde3-42ec-b32c-018dd33e0703 25021-659 HUMAN PRESCRIPTION DRUG Atracurium Besylate atracurium besylate INJECTION, SOLUTION INTRAVENOUS 20120501 ANDA ANDA091488 Sagent Pharmaceuticals ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 25021-660_76599b61-e83b-4d71-987c-3760009dc598 25021-660 HUMAN PRESCRIPTION DRUG Midazolam midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120319 ANDA ANDA090316 Sagent Pharmaceuticals MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 25021-661_76599b61-e83b-4d71-987c-3760009dc598 25021-661 HUMAN PRESCRIPTION DRUG Midazolam midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120319 ANDA ANDA090316 Sagent Pharmaceuticals MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 25021-662_3dacaeb5-617e-4559-8141-2638280591d8 25021-662 HUMAN PRESCRIPTION DRUG rocuronium bromide rocuronium bromide INJECTION, SOLUTION INTRAVENOUS 20111220 ANDA ANDA091458 Sagent Pharmaceuticals ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 25021-671_3ea57cba-ac27-4721-880d-79949a271bf6 25021-671 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride ropivacaine hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20140923 ANDA ANDA090318 Sagent Pharmaceuticals ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 25021-672_2499d6bc-6ece-44f3-b8d7-f68b6d705fd8 25021-672 HUMAN PRESCRIPTION DRUG Atracurium Besylate atracurium besylate INJECTION, SOLUTION INTRAVENOUS 20150731 ANDA ANDA091489 Sagent Pharmaceuticals ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 25021-672_82c1ea14-68eb-4de7-b7aa-9908fa4fbaf6 25021-672 HUMAN PRESCRIPTION DRUG Atracurium Besylate atracurium besylate INJECTION, SOLUTION INTRAVENOUS 20150731 ANDA ANDA091489 Sagent Pharmaceuticals ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 25021-672_b147336d-cde3-42ec-b32c-018dd33e0703 25021-672 HUMAN PRESCRIPTION DRUG Atracurium Besylate atracurium besylate INJECTION, SOLUTION INTRAVENOUS 20120501 ANDA ANDA091489 Sagent Pharmaceuticals ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 25021-673_869af2a0-3d41-4130-9cff-84560599db64 25021-673 HUMAN PRESCRIPTION DRUG glydo lidocaine hydrochloride JELLY TOPICAL 20140915 ANDA ANDA201094 Sagent Pharmaceuticals LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 25021-674_2e4fafc8-5e6f-401c-bf32-4a29c00b6e8d 25021-674 HUMAN PRESCRIPTION DRUG etomidate etomidate INJECTION, SOLUTION INTRAVENOUS 20120810 ANDA ANDA078289 Sagent Pharmaceuticals ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 25021-676_5eb44748-b3d4-4d86-a172-9f03eb804671 25021-676 HUMAN PRESCRIPTION DRUG pentobarbital sodium pentobarbital sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170419 ANDA ANDA206404 Sagent Pharmaceuticals PENTOBARBITAL SODIUM 50 mg/mL CII N 20181231 25021-700_e649a366-3afa-40f1-bdb4-ed7fd0ba40c2 25021-700 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140905 ANDA ANDA091065 Sagent Pharmaceuticals KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 25021-701_e649a366-3afa-40f1-bdb4-ed7fd0ba40c2 25021-701 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140905 ANDA ANDA091065 Sagent Pharmaceuticals KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 25021-703_9a830876-d0b8-437d-9b43-03821f816ae5 25021-703 HUMAN PRESCRIPTION DRUG sumatriptan sumatriptan INJECTION, SOLUTION SUBCUTANEOUS 20131018 ANDA ANDA090314 Sagent Pharmaceuticals SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 25021-703_aadf458c-a289-4ee1-841b-97fa0a38f65d 25021-703 HUMAN PRESCRIPTION DRUG sumatriptan sumatriptan INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA090641 Sagent Pharmaceuticals SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 25021-777_cccc3210-2cf3-47d8-a32c-a9d8cd8d35ff 25021-777 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120830 ANDA ANDA079224 Sagent Pharmaceuticals ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 25021-778_7957939e-e301-41cc-9737-88b0d1bddc84 25021-778 HUMAN PRESCRIPTION DRUG granisetron hydrochloride granisetron hydrochloride INJECTION, SOLUTION INTRAVENOUS 20101201 ANDA ANDA091136 Sagent Pharmaceuticals GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 25021-778_ef34f23f-e35b-4276-a5ec-8c04b6319077 25021-778 HUMAN PRESCRIPTION DRUG granisetron hydrochloride granisetron hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130531 ANDA ANDA091136 Sagent Pharmaceuticals GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 25021-779_7957939e-e301-41cc-9737-88b0d1bddc84 25021-779 HUMAN PRESCRIPTION DRUG granisetron hydrochloride granisetron hydrochloride INJECTION, SOLUTION INTRAVENOUS 20101201 ANDA ANDA091136 Sagent Pharmaceuticals GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 25021-780_ebb64f13-8063-4bcf-a79f-76ab58801dbb 25021-780 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20131101 ANDA ANDA091627 Sagent Pharmaceuticals LEVETIRACETAM 500 mg/5mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 25021-781_2d25ed73-b93e-4d93-9b66-1aa84c5a5849 25021-781 HUMAN PRESCRIPTION DRUG granisetron hydrochloride granisetron hydrochloride INJECTION, SOLUTION INTRAVENOUS 20101201 ANDA ANDA091137 Sagent Pharmaceuticals GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 25021-782_cccc3210-2cf3-47d8-a32c-a9d8cd8d35ff 25021-782 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120830 ANDA ANDA090648 Sagent Pharmaceuticals ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 25021-801_4c05bd56-57ca-4426-9502-d510eb4d8fc7 25021-801 HUMAN PRESCRIPTION DRUG zoledronic acid zoledronic acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20141229 ANDA ANDA091493 Sagent Pharmaceuticals ZOLEDRONIC ACID .8 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 25021-801_9ce8d70f-420d-46fa-86fa-5e07dd11e771 25021-801 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20150901 ANDA ANDA091493 Sagent Pharmaceuticals ZOLEDRONIC ACID .8 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 25021-806_20c4b290-ec53-4fc3-a5ab-4ddca0832f19 25021-806 HUMAN PRESCRIPTION DRUG haloperidol haloperidol lactate INJECTION, SOLUTION INTRAMUSCULAR 20111024 ANDA ANDA091637 Sagent Pharmaceuticals HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20181231 25021-807_0bf9d0ea-b703-4eca-aab3-198f495ce63c 25021-807 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate Methylprednisolone Sodium Succinate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170315 ANDA ANDA040888 Sagent Pharmaceuticals METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 25021-808_0bf9d0ea-b703-4eca-aab3-198f495ce63c 25021-808 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate Methylprednisolone Sodium Succinate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170315 ANDA ANDA040888 Sagent Pharmaceuticals METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 25021-810_0bf9d0ea-b703-4eca-aab3-198f495ce63c 25021-810 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate Methylprednisolone Sodium Succinate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170315 ANDA ANDA040888 Sagent Pharmaceuticals METHYLPREDNISOLONE SODIUM SUCCINATE 1 g/16mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 25021-813_66534ddb-5475-49dd-8b9e-5b00c5e42a46 25021-813 HUMAN PRESCRIPTION DRUG Leucovorin Calcium leucovorin calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131201 ANDA ANDA200753 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 50 mg/5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 25021-813_d2ef5139-ff76-496b-bc14-60ea72916391 25021-813 HUMAN PRESCRIPTION DRUG Leucovorin Calcium leucovorin calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120915 ANDA ANDA200753 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 50 mg/5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 25021-814_66534ddb-5475-49dd-8b9e-5b00c5e42a46 25021-814 HUMAN PRESCRIPTION DRUG Leucovorin Calcium leucovorin calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131201 ANDA ANDA200753 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 100 mg/10mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 25021-814_d2ef5139-ff76-496b-bc14-60ea72916391 25021-814 HUMAN PRESCRIPTION DRUG Leucovorin Calcium leucovorin calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120915 ANDA ANDA200753 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 100 mg/10mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 25021-815_66534ddb-5475-49dd-8b9e-5b00c5e42a46 25021-815 HUMAN PRESCRIPTION DRUG Leucovorin Calcium leucovorin calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131201 ANDA ANDA200753 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 200 mg/20mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 25021-815_d2ef5139-ff76-496b-bc14-60ea72916391 25021-815 HUMAN PRESCRIPTION DRUG Leucovorin Calcium leucovorin calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120915 ANDA ANDA200753 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 200 mg/20mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 25021-816_66534ddb-5475-49dd-8b9e-5b00c5e42a46 25021-816 HUMAN PRESCRIPTION DRUG Leucovorin Calcium leucovorin calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131201 ANDA ANDA200855 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 350 mg/17.5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 25021-816_d2ef5139-ff76-496b-bc14-60ea72916391 25021-816 HUMAN PRESCRIPTION DRUG Leucovorin Calcium leucovorin calcium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120915 ANDA ANDA200855 Sagent Pharmaceuticals LEUCOVORIN CALCIUM 350 mg/17.5mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 25021-817_c4d1a6b3-d119-41ee-8c5f-a4db81ccd269 25021-817 HUMAN PRESCRIPTION DRUG Acetazolamide acetazolamide sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120615 ANDA ANDA200880 Sagent Pharmaceuticals ACETAZOLAMIDE SODIUM 500 mg/5mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 25021-823_20c4b290-ec53-4fc3-a5ab-4ddca0832f19 25021-823 HUMAN PRESCRIPTION DRUG haloperidol haloperidol lactate INJECTION, SOLUTION INTRAMUSCULAR 20111024 ANDA ANDA200742 Sagent Pharmaceuticals HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20181231 25021-824_5ba0c914-789b-4462-9feb-c255cc3a0670 25021-824 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride topotecan hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110627 ANDA ANDA090620 Sagent Pharmaceuticals TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 25021-825_3065128f-3984-4fe1-ab06-91dcedb4b9ec 25021-825 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20111205 ANDA ANDA090343 Sagent Pharmaceuticals LEVOFLOXACIN 5 mg/mL N 20181231 25021-826_68e49abf-c146-4609-b778-d9691ae1fc0b 25021-826 HUMAN PRESCRIPTION DRUG zoledronic acid zoledronic acid INJECTION, SOLUTION INTRAVENOUS 20150901 NDA NDA203231 Sagent Pharmaceuticals ZOLEDRONIC ACID .04 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 25021-826_946934e5-02e2-4173-8b48-cccd203f46cc 25021-826 HUMAN PRESCRIPTION DRUG zoledronic acid zoledronic acid INJECTION, SOLUTION INTRAVENOUS 20150901 NDA NDA203231 Sagent Pharmaceuticals ZOLEDRONIC ACID .04 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 25021-826_ad8928e9-933c-4852-b0b4-97d8f9b05684 25021-826 HUMAN PRESCRIPTION DRUG zoledronic acid zoledronic acid INJECTION, SOLUTION INTRAVENOUS 20130302 NDA NDA203231 Sagent Pharmaceuticals ZOLEDRONIC ACID .04 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 25021-827_3af7be37-c284-47e8-a57a-9f61b7472445 25021-827 HUMAN PRESCRIPTION DRUG ibandronate sodium ibandronate sodium INJECTION, SOLUTION INTRAVENOUS 20140902 ANDA ANDA202235 Sagent Pharmaceuticals IBANDRONATE SODIUM 3 mg/3mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 25021-830_37e15e96-1c39-4add-a00a-6b1933be431f 25021-830 HUMAN PRESCRIPTION DRUG zoledronic acid zoledronic acid INJECTION, SOLUTION INTRAVENOUS 20130302 ANDA ANDA202828 Sagent Pharmaceuticals ZOLEDRONIC ACID .05 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 25021-831_52c9901b-1041-41f8-8a52-5ddaa165cf36 25021-831 HUMAN PRESCRIPTION DRUG haloperidol decanoate haloperidol decanoate INJECTION, SOLUTION INTRAMUSCULAR 20171115 ANDA ANDA205241 Sagent Pharmaceuticals HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] N 20181231 25021-833_52c9901b-1041-41f8-8a52-5ddaa165cf36 25021-833 HUMAN PRESCRIPTION DRUG haloperidol decanoate haloperidol decanoate INJECTION, SOLUTION INTRAMUSCULAR 20171115 ANDA ANDA205241 Sagent Pharmaceuticals HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] N 20181231 25021-834_52c9901b-1041-41f8-8a52-5ddaa165cf36 25021-834 HUMAN PRESCRIPTION DRUG haloperidol decanoate haloperidol decanoate INJECTION, SOLUTION INTRAMUSCULAR 20171115 ANDA ANDA205241 Sagent Pharmaceuticals HALOPERIDOL DECANOATE 500 mg/5mL Typical Antipsychotic [EPC] N 20181231 25113-111_3a23c20b-b279-4a67-b718-acdcf8d4fca5 25113-111 HUMAN OTC DRUG Quiksan Triclosan SOLUTION TOPICAL 20140429 OTC MONOGRAPH NOT FINAL part333E The Dodge Company Inc TRICLOSAN .00025 g/g E 20171231 25113-222_8c42e75e-3cf4-4ed8-9014-db0fee82a1f7 25113-222 HUMAN OTC DRUG Forest Fresh Triclosan SOAP TOPICAL 20140429 OTC MONOGRAPH NOT FINAL part333E The Dodge Company, Inc. TRICLOSAN .004 g/g E 20171231 25113-333_4e11651e-8686-421d-8f58-4befdbb8a2f1 25113-333 HUMAN OTC DRUG Germasidol Triclosan SOAP TOPICAL 20140429 OTC MONOGRAPH NOT FINAL part333A The Dodge Company Inc. TRICLOSAN .0057 g/g E 20171231 25113-444_0e93f7f7-2d34-44c4-8f58-a7b1ff292348 25113-444 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20150203 OTC MONOGRAPH NOT FINAL part333E Dodge ALCOHOL 665 mg/L N 20181231 25208-001_72519bff-80d2-4090-b123-d94df56b1512 25208-001 HUMAN PRESCRIPTION DRUG AGGRASTAT TIROFIBAN INJECTION, SOLUTION INTRAVENOUS 20161015 NDA NDA020912 Medicure International Inc TIROFIBAN HYDROCHLORIDE 3.75 mg/15mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 25208-002_72519bff-80d2-4090-b123-d94df56b1512 25208-002 HUMAN PRESCRIPTION DRUG AGGRASTAT TIROFIBAN INJECTION, SOLUTION INTRAVENOUS 19980514 NDA NDA020913 Medicure International Inc TIROFIBAN HYDROCHLORIDE 5 mg/100mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 25208-100_7ad4ad18-919e-48fe-b630-213ead75a8b6 25208-100 HUMAN PRESCRIPTION DRUG PREXXARTAN PREXXARTAN SOLUTION ORAL 20180102 NDA NDA209139 Medicure International Inc. VALSARTAN 4 mg/mL Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 25225-009_7dc80a3e-3a5a-484f-a99a-641900d8de38 25225-009 HUMAN OTC DRUG Frosted Berry Hand Sanitizer None Frosted Berry Hand Sanitizer LIQUID TOPICAL 20091020 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-010_7ba1230b-8ec2-4f23-9852-55080c87a82d 25225-010 HUMAN OTC DRUG Peppermint Hand Sanitizer None Peppermint Hand Sanitizer LIQUID TOPICAL 20091105 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-011_e58fc07d-5f3a-4956-8d9c-40e36bce36c5 25225-011 HUMAN OTC DRUG Winter Vanilla Hand Sanitizer None Winter Vanilla Hand Sanitizer LIQUID TOPICAL 20091110 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-012_d02476d9-de1a-4540-9152-1b81737ae58e 25225-012 HUMAN OTC DRUG Unscented Hand Sanitizer Alcohol LIQUID TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-013_6e50f16b-808a-40fb-9e32-cdcffaa594f3 25225-013 HUMAN OTC DRUG Citrus Hand Sanitizer Alcohol LIQUID TOPICAL 20100503 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-014_76aa7a03-7510-4442-8954-2ee156582a57 25225-014 HUMAN OTC DRUG Cranberry Hand Sanitizer Alcohol LIQUID TOPICAL 20100503 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-015_b27ce3d7-4792-4b36-91ef-10fcf4d162b1 25225-015 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20100505 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-016_ea062687-2ba6-401a-ab55-a29706669368 25225-016 HUMAN OTC DRUG Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20100503 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 1/1001 E 20171231 25225-017_ca4ff989-8ba7-4485-bbe2-b74ba1e5cf21 25225-017 HUMAN OTC DRUG Strawberry Champagne Hand Sanitizer Alcohol LIQUID TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333 Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-018_644e9c4e-e21a-4319-a1e7-072e856c0c0f 25225-018 HUMAN OTC DRUG Vanilla Fig Hand Sanitizer Alcohol LIQUID TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333E Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-019_623e5ae3-bae8-4739-8d82-d0c5e0f85c97 25225-019 HUMAN OTC DRUG Pomegranate Rose Hand Sanitizer Alcohol LIQUID TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333E Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-020_1bcbf68c-e744-4325-8a63-1ee08a6596f7 25225-020 HUMAN OTC DRUG Honeysuckle Ginger Hand Sanitizer Alcohol LIQUID TOPICAL 20101130 OTC MONOGRAPH NOT FINAL part333E Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-021_b608d672-4c53-444b-bbe3-f6e4753171be 25225-021 HUMAN OTC DRUG Sunkissed Honeydew Hand Sanitizer Alcohol LIQUID TOPICAL 20101113 OTC MONOGRAPH NOT FINAL part333E Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-022_147ae190-584a-4fb9-b7cf-f216b99752aa 25225-022 HUMAN OTC DRUG Coconut Vanilla Hand Sanitizer Alcohol LIQUID TOPICAL 20101113 OTC MONOGRAPH NOT FINAL part333E Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25225-023_24709e22-6de1-4e30-b4cc-8b8be9122b53 25225-023 HUMAN OTC DRUG Aqua Sunset Hand Sanitizer Alcohol LIQUID TOPICAL 20101113 OTC MONOGRAPH NOT FINAL part333E Unique Holding Group Inc ALCOHOL 62 g/100g E 20171231 25237-0515_f41ee57f-b8d5-4801-b8aa-11da4f07d304 25237-0515 HUMAN OTC DRUG Head Remedy Zinc Pyrithione SHAMPOO TOPICAL 20060101 OTC MONOGRAPH FINAL part358H KPSS Inc. PYRITHIONE ZINC 1.5 g/100g E 20171231 25237-0516_c38bb28f-113e-48cb-8e52-509ccb9ecc09 25237-0516 HUMAN OTC DRUG Head Remedy Dandruff Conditioner PYRITHIONE ZINC EMULSION TOPICAL 20060101 OTC MONOGRAPH FINAL part358H KPSS, Inc. PYRITHIONE ZINC 1 g/100g E 20171231 25237-0517_952fd946-e43f-4cea-b306-a5968d001bc4 25237-0517 HUMAN OTC DRUG Dual Senses Scalp Regulation AntiDandruff Shampoo Pyrithione Zinc SHAMPOO TOPICAL 20081028 OTC MONOGRAPH FINAL part358 KPSS Inc. PYRITHIONE ZINC 1.2 g/100g E 20171231 25251-123_23e59ddd-19cb-564c-e054-00144ff8d46c 25251-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030515 UNAPPROVED MEDICAL GAS OxyAir Medical LLC OXYGEN 99 L/100L E 20171231 25280-004_29235929-4425-4b14-b7e1-dcfef5181f86 25280-004 HUMAN OTC DRUG Loesch Anti-Itch Therapy Hydrocortisone LIQUID TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part348 Loesch Laboratory Consultants, Inc. HYDROCORTISONE 5 mg/mL N 20181231 25280-005_cb09aa93-a9c8-473a-8900-878c3b9f677d 25280-005 HUMAN OTC DRUG Loesch Original Kleer-Plex Antimicrobial Face and Body Wash Benzethonium Chloride GEL CUTANEOUS 20140324 OTC MONOGRAPH NOT FINAL part333E Loesch Laboratory Consultants, Inc. BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 25280-006_90e33d83-292f-4724-9336-930dc83eb924 25280-006 HUMAN OTC DRUG Loesch Hair Regrowth Formula Unscented Topical Solution Extra-Strength for Men Minoxidil SOLUTION TOPICAL 20140730 ANDA ANDA075598 Loesch Laboratory Consultants, Inc. MINOXIDIL 3 g/60mL N 20181231 25280-007_c58c6688-e81b-412d-b648-fabd8290ea09 25280-007 HUMAN OTC DRUG Loesch Hair Regrowth Formula Unscented Topical Solution Regular-Strength for Men and Women Minoxidil SOLUTION TOPICAL 20140811 ANDA ANDA075357 Loesch Laboratory Consultants, Inc. MINOXIDIL 2 g/100mL N 20181231 25280-008_5cf21fab-2562-2573-e053-2991aa0a9d67 25280-008 HUMAN OTC DRUG Loesch HC-10 ANTI-ITCH THERAPY Hydrocortisone liquid LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part348 Loesch Laboratory Consultants, INC. HYDROCORTISONE 9 mg/mL N 20181231 25336-5563_b5b673c6-bf0f-4b84-9605-6d3b5d80df0f 25336-5563 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19690101 UNAPPROVED MEDICAL GAS Buffalo Welding Corp OXYGEN 99 L/100L E 20171231 25357-022_36fa4d7a-8038-445c-b8e4-72c1e86e5f43 25357-022 HUMAN PRESCRIPTION DRUG Photrexa Viscous riboflavin 5-phosphate in 20% dextran ophthalmic SOLUTION/ DROPS OPHTHALMIC 20160415 NDA NDA203324 Avedro, Inc. RIBOFLAVIN 5'-PHOSPHATE SODIUM 1.46 mg/mL N 20191231 25357-023_36fa4d7a-8038-445c-b8e4-72c1e86e5f43 25357-023 HUMAN PRESCRIPTION DRUG Photrexa riboflavin 5-phosphate ophthalmic SOLUTION/ DROPS OPHTHALMIC 20160415 NDA NDA203324 Avedro, Inc. RIBOFLAVIN 5'-PHOSPHATE SODIUM 1.46 mg/mL N 20191231 25373-001_26b334d5-39d0-410f-ae52-a26532f7d4e0 25373-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19901119 UNAPPROVED MEDICAL GAS Linde Gas North America LLC OXYGEN 99 L/100L N 20181231 25373-002_a096832c-3e18-41ea-a92c-da855761c089 25373-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19901127 UNAPPROVED MEDICAL GAS Linde Gas North America LLC NITROGEN 99 L/100L N 20181231 25373-003_a7fe6f07-8d2b-4280-b186-b3463272bd4d 25373-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19901127 UNAPPROVED MEDICAL GAS Linde Gas North America LLC NITROUS OXIDE 99 L/100L N 20181231 25373-004_caedeeaf-8934-4eed-8b01-643407036337 25373-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19901128 UNAPPROVED MEDICAL GAS Linde Gas North America LLC CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 25373-006_b50398fd-12c9-4afb-9a88-b73fab19481b 25373-006 HUMAN PRESCRIPTION DRUG Air, Compressed Nitrogen, Oxygen GAS RESPIRATORY (INHALATION) 19891108 NDA NDA205765 Linde Gas North America LLC OXYGEN 21 L/100L N 20181231 25373-010_5b433912-2f79-4743-85b0-2da5d8e7db1d 25373-010 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19901127 NDA NDA206826 Linde Gas North America LLC HELIUM 99 L/100L N 20181231 25373-011_5b5a5544-f5e7-4f3f-86b8-70a477874d34 25373-011 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE AND OXYGEN MIXTURE, COMPRESSED, OXIDIZING, N.O.S. Oxygen, Carbon Dioxide GAS RESPIRATORY (INHALATION) 19980624 UNAPPROVED MEDICAL GAS Linde Gas North America LLC OXYGEN; CARBON DIOXIDE 95; 5 L/100L; L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 25373-012_66fccd6c-8381-4f9c-9a92-f54aae0c263a 25373-012 HUMAN PRESCRIPTION DRUG COMPRESSED, N.O.S. Helium, Oxygen GAS RESPIRATORY (INHALATION) 19980624 UNAPPROVED MEDICAL GAS Linde Gas North America LLC HELIUM; OXYGEN 79; 21 L/100L; L/100L N 20181231 25373-101_a6a5da58-0cb9-4b76-9673-970c1e71a4d8 25373-101 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860616 UNAPPROVED MEDICAL GAS Linde Gas North America LLC OXYGEN 99 L/100L N 20181231 25373-102_943b14ce-af18-49da-9d9a-acc8288c30f5 25373-102 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19860801 UNAPPROVED MEDICAL GAS Linde Gas North America LLC NITROGEN 99 L/100L N 20181231 25373-103_7b3d6144-1a61-4ebb-affd-0d91457c3960 25373-103 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19860616 UNAPPROVED MEDICAL GAS Linde Gas North America LLC NITROUS OXIDE 99 L/100L N 20181231 25373-104_507bcc65-0c76-49fe-a16f-ce3018c0886b 25373-104 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19901127 UNAPPROVED MEDICAL GAS Linde Gas North America LLC CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 25373-703_1c2687bf-10f7-4cca-b5bb-6fd90c52539c 25373-703 HUMAN PRESCRIPTION DRUG Nitrous Oxide Sedara Nitrous Oxide GAS RESPIRATORY (INHALATION) 20120618 UNAPPROVED MEDICAL GAS Linde Gas North America LLC NITROUS OXIDE 990 mL/L N 20181231 25543-001_0f728cea-adcf-4551-83c5-3d9a135d806c 25543-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870813 UNAPPROVED MEDICAL GAS Airgas East, Inc. OXYGEN 995 mL/L E 20171231 25543-004_10690114-2bf9-4ef5-ad9c-c485b58f974c 25543-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19910122 UNAPPROVED MEDICAL GAS Airgas East, Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 25543-005_ef46c79e-1c19-4904-a310-30c085c4b7fc 25543-005 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19910115 UNAPPROVED MEDICAL GAS Airgas East, Inc. AIR 1000 mL/L E 20171231 25543-011_e310afbc-50fa-4883-921e-792b38c6c391 25543-011 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19980217 UNAPPROVED MEDICAL GAS Airgas East, Inc. HELIUM 999 mL/L E 20171231 25543-012_1e8dfa9a-3cc1-4cbe-84c4-12ad149b2027 25543-012 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19910115 UNAPPROVED MEDICAL GAS Airgas East, Inc. NITROUS OXIDE 990 mL/L E 20171231 25543-100_6bfe5cda-a1bf-47fc-ad06-e55e48df8bd0 25543-100 HUMAN PRESCRIPTION DRUG Oxygen, Refrigerated Liquid Oxygen, Refrigerated Liquid GAS RESPIRATORY (INHALATION) 20100416 NDA NDA205840 AirGas East OXYGEN 1 L/L N 20181231 25543-200_471ee79b-38f1-4881-ac24-97a7fffe0a6f 25543-200 HUMAN PRESCRIPTION DRUG Tri-Med Medical Compressed Oxygen GAS RESPIRATORY (INHALATION) 20100422 NDA NDA205840 AirGas East OXYGEN 1 L/L N 20181231 25682-001_0fb572bf-8c29-405e-bdc3-708e2d6d1c36 25682-001 HUMAN PRESCRIPTION DRUG SOLIRIS ECULIZUMAB INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20070402 BLA BLA125166 Alexion Pharmaceuticals Inc. ECULIZUMAB 300 mg/30mL Complement Inhibitor [EPC],Complement Inhibitors [MoA] N 20181231 25682-007_1a7945ac-ac7a-4fd8-920f-ec3aa7ee6ff0 25682-007 HUMAN PRESCRIPTION DRUG KANUMA Sebelipase alfa INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20151208 BLA BLA125561 Alexion Pharmaceuticals, Inc. SEBELIPASE ALFA 2 mg/mL Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC],Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC],Lysosomal Acid Cholesterol Esterase [Chemical/Ingredient] N 20181231 25682-010_82e667d9-dbd1-40df-8a25-10f6e3e58c82 25682-010 HUMAN PRESCRIPTION DRUG Strensiq asfotase alfa SOLUTION SUBCUTANEOUS 20151023 BLA BLA125513 Alexion Pharmaceuticals Inc. ASFOTASE ALFA 18 mg/.45mL Tissue-nonspecific Alkaline Phosphatase [EPC],Alkaline Phosphatase [Chemical/Ingredient] N 20181231 25682-013_82e667d9-dbd1-40df-8a25-10f6e3e58c82 25682-013 HUMAN PRESCRIPTION DRUG Strensiq asfotase alfa SOLUTION SUBCUTANEOUS 20151023 BLA BLA125513 Alexion Pharmaceuticals Inc. ASFOTASE ALFA 28 mg/.7mL Tissue-nonspecific Alkaline Phosphatase [EPC],Alkaline Phosphatase [Chemical/Ingredient] N 20181231 25682-016_82e667d9-dbd1-40df-8a25-10f6e3e58c82 25682-016 HUMAN PRESCRIPTION DRUG Strensiq asfotase alfa SOLUTION SUBCUTANEOUS 20151023 BLA BLA125513 Alexion Pharmaceuticals Inc. ASFOTASE ALFA 40 mg/mL Tissue-nonspecific Alkaline Phosphatase [EPC],Alkaline Phosphatase [Chemical/Ingredient] N 20181231 25682-019_82e667d9-dbd1-40df-8a25-10f6e3e58c82 25682-019 HUMAN PRESCRIPTION DRUG Strensiq asfotase alfa SOLUTION SUBCUTANEOUS 20151023 BLA BLA125513 Alexion Pharmaceuticals Inc. ASFOTASE ALFA 80 mg/.8mL Tissue-nonspecific Alkaline Phosphatase [EPC],Alkaline Phosphatase [Chemical/Ingredient] N 20181231 25685-715_d3d9fdf9-b40f-4768-a1e3-63c13805c145 25685-715 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate brimonidine tartrate SOLUTION/ DROPS OPHTHALMIC 20160303 ANDA ANDA076439 Regimed Medical BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 26050-101_64442e05-8714-2710-e053-2991aa0ae80b 26050-101 HUMAN OTC DRUG Anti Acne Natural Volcanic Sulfur SULFUR SOAP TOPICAL 20121001 OTC MONOGRAPH FINAL part333D Galenium Pharmasia Laboratories, PT SULFUR 10 g/100g N 20191231 26050-101_64448b93-0a1f-dd29-e053-2a91aa0aa0c5 26050-101 HUMAN OTC DRUG Anti Acne Natural Volcanic Sulfur SULFUR SOAP TOPICAL 20121001 OTC MONOGRAPH FINAL part333D Galenium Pharmasia Laboratories, PT SULFUR 10 g/100g N 20191231 26050-112_64448b93-0a2e-dd29-e053-2a91aa0aa0c5 26050-112 HUMAN OTC DRUG Joesoef Skincare Anti Acne Sulfur LOTION TOPICAL 20061001 OTC MONOGRAPH FINAL part333D PT Galenium Pharmasia Laboratories SULFUR 6.3 1/95mL N 20191231 26052-010_3101e252-1530-15d6-e054-00144ff8d46c 26052-010 HUMAN OTC DRUG NAS PURIFYING CLEANSER SALICYLIC ACID GEL TOPICAL 20100201 OTC MONOGRAPH FINAL part333D Burt's Bees, Inc. SALICYLIC ACID 1 g/100mL N 20181231 26052-011_3102f14b-be7d-116f-e054-00144ff88e88 26052-011 HUMAN OTC DRUG NAS Targeted Spot Treatment SALICYLIC ACID LIQUID TOPICAL 20100201 OTC MONOGRAPH FINAL part333D Burt's Bees SALICYLIC ACID .75 g/100g N 20181231 26052-012_318e1519-cc4a-4a17-e054-00144ff8d46c 26052-012 HUMAN OTC DRUG NAS DAILY MOISTURIZING SALICYLIC ACID LOTION TOPICAL 20140102 OTC MONOGRAPH FINAL part333D BURT'S BEES, INC. SALICYLIC ACID 1 g/100g N 20181231 26052-013_310557bf-9f34-6266-e054-00144ff8d46c 26052-013 HUMAN OTC DRUG NAS PORE REFINING SCRUB SALICYLIC ACID EMULSION TOPICAL 20140102 OTC MONOGRAPH FINAL part333D BURT'S BEES, INC. SALICYLIC ACID 1 g/100g N 20181231 26052-017_fe5af802-5290-442f-a715-7b8c54fa2e38 26052-017 HUMAN OTC DRUG Natural Acne Solutions Clarifying Toner salicylic acid LIQUID TOPICAL 20100601 OTC MONOGRAPH FINAL part333 Burt's Bees, Inc. SALICYLIC ACID 1 mL/100mL E 20171231 26052-020_316755ab-b91d-510d-e054-00144ff88e88 26052-020 HUMAN OTC DRUG NATURAL THROAT DROPS HONEY POMEGRANATE MENTHOL LOZENGE ORAL 20111101 OTC MONOGRAPH NOT FINAL part356 BURT'S BEES, INC. MENTHOL 2 mg/3g N 20181231 26052-022_316a2d5e-4c7f-4b61-e054-00144ff88e88 26052-022 HUMAN OTC DRUG NAS MAX STRENGTH SPOT TREATMENT SALICYLIC ACID CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part333D BURT'S BEES, INC. SALICYLIC ACID 2 g/100g N 20181231 26052-023_3168090a-ad37-103f-e054-00144ff8d46c 26052-023 HUMAN OTC DRUG NATURAL THROAT DROPS HONEY MENTHOL LOZENGE ORAL 20111101 OTC MONOGRAPH NOT FINAL part356 BURT'S BEES, INC. MENTHOL 2 mg/3g N 20181231 26052-024_3169d3c3-f604-5cbc-e054-00144ff8d46c 26052-024 HUMAN OTC DRUG NATURAL THROAT DROPS HONEY LEMON MENTHOL LOZENGE ORAL 20111101 OTC MONOGRAPH NOT FINAL part356 BURT'S BEES MENTHOL 2 mg/3g N 20181231 26052-027_307502c3-3de0-3a99-e054-00144ff88e88 26052-027 HUMAN OTC DRUG Renewal Firming Day Broad Spectrum SPF 30 Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20150101 OTC MONOGRAPH FINAL part352 BURT'S BEES, INC. TITANIUM DIOXIDE; ZINC OXIDE 2.53; 11.9 g/100g; g/100g N 20181231 26052-028_318fec04-6386-26ea-e054-00144ff8d46c 26052-028 HUMAN OTC DRUG BURTS BEES BABY BEE DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20150529 OTC MONOGRAPH FINAL part347 BURT'S BEES, INC. ZINC OXIDE 40 g/100g N 20181231 26052-029_319042c8-a855-059d-e054-00144ff88e88 26052-029 HUMAN OTC DRUG MEDICATED LIP BALM MENTHOL AND EUCALYPTUS STICK TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part348 Burt's Bees, Inc. MENTHOL .9 g/100g N 20181231 26052-030_3150ef71-2ea2-25d0-e054-00144ff88e88 26052-030 HUMAN OTC DRUG BB Broad Spectrum SPF 15 Light Zinc Oxide Titanium Dioxide CREAM TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Burt's Bees TITANIUM DIOXIDE; ZINC OXIDE 5.3; 7 g/100g; g/100g N 20181231 26052-031_33ad783f-b630-6a70-e054-00144ff8d46c 26052-031 HUMAN OTC DRUG BB Broad Spectrum SPF 15 Light to Medium Zinc Oxide Titanium Dioxide CREAM TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Burt's Bees TITANIUM DIOXIDE; ZINC OXIDE 4.7; 7 g/100g; g/100g N 20181231 26052-032_3346f41e-32d1-35d0-e054-00144ff88e88 26052-032 HUMAN OTC DRUG BB Broad Spectrum SPF 15 Medium Zinc Oxide Titanium Dioxide CREAM TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Burt's Bees ZINC OXIDE; TITANIUM DIOXIDE 7; 4.7 g/100g; g/100g N 20181231 26052-035_3165a1c3-b39e-0faa-e054-00144ff8d46c 26052-035 HUMAN OTC DRUG Natural Acne Solutions 3 Step Regimen salicylic acid KIT 20140102 OTC MONOGRAPH FINAL part333D Burt's Bees E 20171231 26124-001_77e13180-889a-4be7-b3b5-66fbbf67af0e 26124-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19720110 NDA NDA205889 HELGET, INC. OXYGEN 99.9 L/L N 20181231 26482-0001_82f8c83e-c34f-4198-a96f-11d7520712d7 26482-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20061115 UNAPPROVED MEDICAL GAS Corner Medical OXYGEN 99 L/100L E 20171231 26509-0002_3e1a335c-8dc7-4922-9b68-ea2c715b69e4 26509-0002 HUMAN OTC DRUG Clorox Care Concepts Hand Sanitizer alcohol SOLUTION TOPICAL 20140407 OTC MONOGRAPH NOT FINAL part333A The Clorox Company ALCOHOL 67 mL/100mL E 20171231 26509-0003_07d658ef-7632-4b98-e054-00144ff8d46c 26509-0003 HUMAN OTC DRUG Clorox Care Concepts Antimicrobial benzalkonium chloride SOAP TOPICAL 20140407 OTC MONOGRAPH NOT FINAL part333A The Clorox Company BENZALKONIUM CHLORIDE .12 g/100mL E 20171231 26509-0010_2561abfd-61dc-562c-e054-00144ff8d46c 26509-0010 HUMAN OTC DRUG Clorox Antimicrobial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160125 OTC MONOGRAPH NOT FINAL part333A The Clorox Company ALCOHOL 620 mg/mL E 20171231 26509-0011_25c77b1c-8450-633e-e054-00144ff8d46c 26509-0011 HUMAN OTC DRUG Clorox Antimicrobial Chloroxylenol SOAP TOPICAL 20160125 OTC MONOGRAPH NOT FINAL part333A The Clorox Company CHLOROXYLENOL 5 mg/mL E 20171231 26509-0106_232da59b-b657-4a35-e054-00144ff88e88 26509-0106 HUMAN OTC DRUG Clorox Hand Sanitizer Alcohol SOLUTION TOPICAL 20061106 OTC MONOGRAPH NOT FINAL part333A The Clorox Company ALCOHOL 71 mL/100mL N 20181231 26550-001_402ff70a-1f52-0e6d-e054-00144ff8d46c 26550-001 HUMAN OTC DRUG X3 Clean BENZALKONIUM CHLORIDE AEROSOL, FOAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333A X3 Labs Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 26550-001_e3c9449c-64c1-4964-a1ec-2636c0aeb29c 26550-001 HUMAN OTC DRUG X3 Clean Hand Sanitizer Spray SPRAY TOPICAL 20090901 OTC MONOGRAPH FINAL part333 X3 Labs Inc. BENZALKONIUM CHLORIDE 1.3 uL/mL N 20181231 26550-002_40cc6501-3cef-24cc-e054-00144ff88e88 26550-002 HUMAN OTC DRUG X3 Clean BENZALKONIUM CHLORIDE SPRAY TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333A X3 Labs Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 26637-321_e298e808-5b93-46ab-a2d4-e703bc5c58d7 26637-321 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Putney Inc AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 26637-541_2a96a186-c6ca-46b3-890a-c372c4fbc2fb 26637-541 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20150220 ANDA ANDA062421 Putney, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 26637-711_93444621-5f55-4b90-a427-ef2cc82136ef 26637-711 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil TABLET, FILM COATED ORAL 20080528 ANDA ANDA065462 Putney Inc CEFPODOXIME PROXETIL 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 26637-712_93444621-5f55-4b90-a427-ef2cc82136ef 26637-712 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil TABLET, FILM COATED ORAL 20080528 ANDA ANDA065462 Putney Inc CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 26637-841_76162610-eea2-4d6d-b7f0-c1f6f1702bfd 26637-841 HUMAN PRESCRIPTION DRUG Neomycin and polymyxin B sulfates and bacitracin zinc neomycin sulfate, polymyxin B sulfate, bacitracin zinc OINTMENT OPHTHALMIC 20160111 ANDA ANDA060764 Putney, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] E 20171231 26637-941_681d27fa-de41-43c3-abed-0b70ea286012 26637-941 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Dexamethasone, Neomycin sulfate, Polymysin B sulfate OINTMENT OPHTHALMIC 20160229 ANDA ANDA062938 Putney, Inc. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 26866-001_18438c1a-c5da-4b77-b121-9a0fbca4c63a 26866-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130731 UNAPPROVED MEDICAL GAS Bandy's Pharmacy Inc OXYGEN 99 L/100L E 20171231 27017-019_0d544bcc-babe-40eb-8c51-e5e40142fae9 27017-019 HUMAN OTC DRUG Xlear Max homeopathic nasal spray SPRAY, METERED NASAL 20160713 UNAPPROVED HOMEOPATHIC Xlear Inc CAPSICUM ANNUUM WHOLE .005 g/g E 20171231 27017-054_cfdfec1c-cb1b-42ec-8233-c65ade9025ca 27017-054 HUMAN OTC DRUG Spry Xylitol Cinnamon Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120201 OTC MONOGRAPH FINAL part355 Xlear Inc. SODIUM FLUORIDE .28 g/113g E 20171231 27190-100_15077527-4901-4813-ac6c-0adc304c7976 27190-100 HUMAN PRESCRIPTION DRUG OXYGEN, REFRIGERATED OXYGEN GAS RESPIRATORY (INHALATION) 20100218 UNAPPROVED MEDICAL GAS Patient Aids, Inc. dba Home Respiratory Service OXYGEN 1 L/L E 20171231 27241-001_9f611f1b-7ed0-48b3-a72e-62690f809f32 27241-001 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140328 ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-002_9f611f1b-7ed0-48b3-a72e-62690f809f32 27241-002 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140328 ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-003_9f611f1b-7ed0-48b3-a72e-62690f809f32 27241-003 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140328 ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-004_9f611f1b-7ed0-48b3-a72e-62690f809f32 27241-004 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140328 ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-005_9f611f1b-7ed0-48b3-a72e-62690f809f32 27241-005 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140328 ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-006_9f611f1b-7ed0-48b3-a72e-62690f809f32 27241-006 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140328 ANDA ANDA201003 Ajanta Pharma Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-007_0335364f-0704-41c8-8a1b-3120a7ad414b 27241-007 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, FILM COATED ORAL 20110614 ANDA ANDA201293 Ajanta Pharma Limited LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 27241-008_0335364f-0704-41c8-8a1b-3120a7ad414b 27241-008 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, FILM COATED ORAL 20110614 ANDA ANDA201293 Ajanta Pharma Limited LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 27241-009_0335364f-0704-41c8-8a1b-3120a7ad414b 27241-009 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, FILM COATED ORAL 20110614 ANDA ANDA201293 Ajanta Pharma Limited LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 27241-010_0335364f-0704-41c8-8a1b-3120a7ad414b 27241-010 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, FILM COATED ORAL 20110614 ANDA ANDA201293 Ajanta Pharma Limited LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 27241-015_bd1abe4a-e140-45c4-92df-4a71e08a58f5 27241-015 HUMAN PRESCRIPTION DRUG MONTELUKAST SODIUM MONTELUKAST SODIUM GRANULE ORAL 20150813 ANDA ANDA203438 Ajanta Pharma Limited MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 27241-016_bd1abe4a-e140-45c4-92df-4a71e08a58f5 27241-016 HUMAN PRESCRIPTION DRUG MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET, CHEWABLE ORAL 20150813 ANDA ANDA203328 Ajanta Pharma Limited MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 27241-017_bd1abe4a-e140-45c4-92df-4a71e08a58f5 27241-017 HUMAN PRESCRIPTION DRUG MONTELUKAST SODIUM MONTELUKAST TABLET, CHEWABLE ORAL 20150813 ANDA ANDA203328 Ajanta Pharma Limited MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 27241-018_bd1abe4a-e140-45c4-92df-4a71e08a58f5 27241-018 HUMAN PRESCRIPTION DRUG MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET, COATED ORAL 20150813 ANDA ANDA203432 Ajanta Pharma Limited MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 27241-019_dd3c9820-4edc-4a8f-aede-32cfb9812b80 27241-019 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20161018 ANDA ANDA203957 Ajanta Pharma Limited LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 27241-020_dd3c9820-4edc-4a8f-aede-32cfb9812b80 27241-020 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20161018 ANDA ANDA203957 Ajanta Pharma Limited LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 27241-021_2059c681-fd5b-47f4-89a7-26866eea9982 27241-021 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET ORAL 20160531 ANDA ANDA204041 Ajanta Pharma Limited ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 27241-022_2059c681-fd5b-47f4-89a7-26866eea9982 27241-022 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET ORAL 20160531 ANDA ANDA204041 Ajanta Pharma Limited ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 27241-025_812afc86-1a73-4ed2-81db-adea796b5ccd 27241-025 HUMAN PRESCRIPTION DRUG olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20170310 ANDA ANDA204320 Ajanta Pharma Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-026_812afc86-1a73-4ed2-81db-adea796b5ccd 27241-026 HUMAN PRESCRIPTION DRUG olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20170310 ANDA ANDA204320 Ajanta Pharma Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-027_812afc86-1a73-4ed2-81db-adea796b5ccd 27241-027 HUMAN PRESCRIPTION DRUG olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20170310 ANDA ANDA204320 Ajanta Pharma Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-028_812afc86-1a73-4ed2-81db-adea796b5ccd 27241-028 HUMAN PRESCRIPTION DRUG olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20170310 ANDA ANDA204320 Ajanta Pharma Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-029_1cf29091-886b-417f-98cc-d75b991b6603 27241-029 HUMAN PRESCRIPTION DRUG Omeprazole/Sodium Bicarbonate Omeprazole/Sodium Bicarbonate POWDER, FOR SUSPENSION ORAL 20170105 ANDA ANDA205545 Ajanta Pharma Limited OMEPRAZOLE; SODIUM BICARBONATE 20; 1680 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 27241-030_1cf29091-886b-417f-98cc-d75b991b6603 27241-030 HUMAN PRESCRIPTION DRUG Omeprazole/Sodium Bicarbonate Omeprazole/Sodium Bicarbonate POWDER, FOR SUSPENSION ORAL 20170105 ANDA ANDA205545 Ajanta Pharma Limited OMEPRAZOLE; SODIUM BICARBONATE 40; 1680 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 27241-031_4c84d31a-b9ec-438d-ab28-75a62d0b6a15 27241-031 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20161115 ANDA ANDA204228 Ajanta Pharma Limited OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 27241-032_4c84d31a-b9ec-438d-ab28-75a62d0b6a15 27241-032 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20161115 ANDA ANDA204228 Ajanta Pharma Limited OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 27241-033_4b324e8f-6fc5-477e-b698-11e82fe361aa 27241-033 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20150120 ANDA ANDA203685 Ajanta Pharma Limited IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 27241-035_4b324e8f-6fc5-477e-b698-11e82fe361aa 27241-035 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20150120 ANDA ANDA203685 Ajanta Pharma Limited IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 27241-036_4b324e8f-6fc5-477e-b698-11e82fe361aa 27241-036 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20150120 ANDA ANDA203685 Ajanta Pharma Limited IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 27241-039_e18a3f00-4d8f-4160-9507-4398b4f607f9 27241-039 HUMAN PRESCRIPTION DRUG eletriptan hydrobromide eletriptan hydrobromide TABLET, FILM COATED ORAL 20170829 ANDA ANDA205186 Ajanta Pharma Limited ELETRIPTAN HYDROBROMIDE 20 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 27241-040_e18a3f00-4d8f-4160-9507-4398b4f607f9 27241-040 HUMAN PRESCRIPTION DRUG eletriptan hydrobromide eletriptan hydrobromide TABLET, FILM COATED ORAL 20170829 ANDA ANDA205186 Ajanta Pharma Limited ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 27241-041_a66362aa-a4c0-4b36-b77f-77b5d6826d9d 27241-041 HUMAN PRESCRIPTION DRUG almotriptan almotriptan TABLET, FILM COATED ORAL 20151007 ANDA ANDA205523 Ajanta Pharma Limited ALMOTRIPTAN MALATE 6.25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 27241-042_a66362aa-a4c0-4b36-b77f-77b5d6826d9d 27241-042 HUMAN PRESCRIPTION DRUG almotriptan almotriptan TABLET, FILM COATED ORAL 20151007 ANDA ANDA205523 Ajanta Pharma Limited ALMOTRIPTAN MALATE 12.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 27241-049_d13472d1-46a5-4f53-91c1-c52f6ec423d6 27241-049 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET ORAL 20170831 ANDA ANDA205792 Ajanta Pharma Limited ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 27241-051_bbed48f8-d327-4d38-9970-801483df0472 27241-051 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170530 ANDA ANDA206174 Ajanta Pharma Limited ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20191231 27241-052_bbed48f8-d327-4d38-9970-801483df0472 27241-052 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170530 ANDA ANDA206174 Ajanta Pharma Limited ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20191231 27241-053_bbed48f8-d327-4d38-9970-801483df0472 27241-053 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170530 ANDA ANDA206174 Ajanta Pharma Limited ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20191231 27241-054_bbed48f8-d327-4d38-9970-801483df0472 27241-054 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170530 ANDA ANDA206174 Ajanta Pharma Limited ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20191231 27241-055_bbed48f8-d327-4d38-9970-801483df0472 27241-055 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170530 ANDA ANDA206174 Ajanta Pharma Limited ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20191231 27241-056_bbed48f8-d327-4d38-9970-801483df0472 27241-056 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170530 ANDA ANDA206174 Ajanta Pharma Limited ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20191231 27241-062_97d6a40e-4a29-4e98-937f-4255e2e3194e 27241-062 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET ORAL 20160531 ANDA ANDA206181 Ajanta Pharma Limited VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 27241-063_97d6a40e-4a29-4e98-937f-4255e2e3194e 27241-063 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET ORAL 20160531 ANDA ANDA206181 Ajanta Pharma Limited VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 27241-070_8f22f351-3fb4-45b7-a473-d9dcb43b2ac7 27241-070 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20150827 ANDA ANDA206528 Ajanta Pharma Limited MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 27241-071_8f22f351-3fb4-45b7-a473-d9dcb43b2ac7 27241-071 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20150827 ANDA ANDA206528 Ajanta Pharma Limited MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 27241-076_288c8fdc-78c0-4fb3-b19a-063732ae5093 27241-076 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20170316 ANDA ANDA206711 Ajanta Pharma Limited OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-077_288c8fdc-78c0-4fb3-b19a-063732ae5093 27241-077 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20170316 ANDA ANDA206711 Ajanta Pharma Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-078_288c8fdc-78c0-4fb3-b19a-063732ae5093 27241-078 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20170316 ANDA ANDA206711 Ajanta Pharma Limited OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-079_288c8fdc-78c0-4fb3-b19a-063732ae5093 27241-079 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20170316 ANDA ANDA206711 Ajanta Pharma Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-080_288c8fdc-78c0-4fb3-b19a-063732ae5093 27241-080 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20170316 ANDA ANDA206711 Ajanta Pharma Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-081_288c8fdc-78c0-4fb3-b19a-063732ae5093 27241-081 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20170316 ANDA ANDA206711 Ajanta Pharma Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 27241-083_93635e74-6eca-4188-86e6-b22bf6272345 27241-083 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Olmesartan medoxomil Amlodipine besylate and Olmesartan medoxomil TABLET ORAL 20170202 ANDA ANDA207216 Ajanta Pharma Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 27241-084_93635e74-6eca-4188-86e6-b22bf6272345 27241-084 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Olmesartan medoxomil Amlodipine besylate and Olmesartan medoxomil TABLET ORAL 20170202 ANDA ANDA207216 Ajanta Pharma Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 27241-085_93635e74-6eca-4188-86e6-b22bf6272345 27241-085 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Olmesartan medoxomil Amlodipine besylate and Olmesartan medoxomil TABLET ORAL 20170202 ANDA ANDA207216 Ajanta Pharma Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 27241-086_93635e74-6eca-4188-86e6-b22bf6272345 27241-086 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Olmesartan medoxomil Amlodipine besylate and Olmesartan medoxomil TABLET ORAL 20170202 ANDA ANDA207216 Ajanta Pharma Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 27241-090_4064c8a4-3dba-4a89-9e5f-5693ffa61475 27241-090 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20170928 ANDA ANDA207797 Ajanta Pharma Limited RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 27241-091_4064c8a4-3dba-4a89-9e5f-5693ffa61475 27241-091 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20170928 ANDA ANDA207797 Ajanta Pharma Limited RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 27241-092_4064c8a4-3dba-4a89-9e5f-5693ffa61475 27241-092 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20170928 ANDA ANDA207797 Ajanta Pharma Limited RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 27241-093_4064c8a4-3dba-4a89-9e5f-5693ffa61475 27241-093 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20170928 ANDA ANDA207797 Ajanta Pharma Limited RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 27241-097_52784e10-dcfc-4a6b-831a-a9d5aecf8b55 27241-097 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20170316 ANDA ANDA208706 Ajanta Pharma Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 27241-098_52784e10-dcfc-4a6b-831a-a9d5aecf8b55 27241-098 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20170316 ANDA ANDA208706 Ajanta Pharma Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 27241-099_52784e10-dcfc-4a6b-831a-a9d5aecf8b55 27241-099 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20170316 ANDA ANDA208706 Ajanta Pharma Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 27241-108_be2a5679-b6f4-4763-8c2b-2e16d37222ea 27241-108 HUMAN PRESCRIPTION DRUG Clonidine hydrochloride Clonidine hydrochloride TABLET, EXTENDED RELEASE ORAL 20171121 ANDA ANDA209686 Ajanta Pharma Limited CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 27281-001_56434350-d8b9-4b08-b767-67818f9939bf 27281-001 HUMAN OTC DRUG Brain Power Semecarpus Anacardium Juice, Arnica Montana, Calcium Fluoride, Silybum Marianum Seed, Chincona Officinalis Bark, Herring Sperm DNA, Ginkgo, Egg Phospholipids, Achillea Millefolium, Phosphoric Acid, Saccharomyces Cerevisia RNA, Silicon Dioxide, and Zinc Sulphate Heptahydrate SPRAY ORAL 20131118 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC SEMECARPUS ANACARDIUM JUICE; ARNICA MONTANA; CALCIUM FLUORIDE; SILYBUM MARIANUM SEED OIL; CINCHONA OFFICINALIS BARK; HERRING SPERM DNA; GINKGO; EGG PHOSPHOLIPIDS; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID; SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE; ZINC SULFATE HEPTAHYDRATE 30; 1.5; 30; 1.5; 3; 3; 3; 6; 1.5; 30; 6; 6; 6 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 27281-002_7f5efd40-6f63-46c3-bc14-38b2495ff732 27281-002 HUMAN OTC DRUG Livergen Arnica Montana, Byronia Alba Root, Silybum Marianum Seed, Chelidonium Majus, Herring Sperm DNA, Pork Liver, Cervus Elaphus Horn Oil, Sus Scrofa Pancreas, and Taraxacum Officinale SPRAY ORAL 20131113 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC ARNICA MONTANA; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED OIL; CHELIDONIUM MAJUS; HERRING SPERM DNA; PORK LIVER; CERVUS ELAPHUS HORN OIL; SUS SCROFA PANCREAS; TARAXACUM OFFICINALE 1.5; 200; .5; 200; 3; 3; 4; 4; 1 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 27281-003_82f2f5e1-c82d-4ef9-828b-57ec557750bf 27281-003 HUMAN OTC DRUG Vivacity Alfalfa, Aralia Quinquefolia, Arnica Montana, Avena Sativa, DNA, Galium Aparine, Hypericum Perforatum, Oleum Animale, Pituitarium Posterium, Rhus Toxicodendron, RNA, Thuja Occidentalis, Alcohol, Glycerin, Water SPRAY ORAL 20131113 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC ALFALFA; ARNICA MONTANA; AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; GALIUM APARINE; HERRING SPERM DNA; HYPERICUM PERFORATUM; CERVUS ELAPHUS HORN OIL; SUS SCROFA PITUITARY GLAND; TOXICODENDRON PUBESCENS LEAF; SACCHAROMYCES CEREVISIAE RNA; THUJA OCCIDENTALIS LEAFY TWIG 1; 1.5; 1; 1; 1.5; 3; 200; 3; 4; 200; 3; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 27281-004_9990ab02-44b3-4178-9626-78991a4a4c86 27281-004 HUMAN OTC DRUG Immune Booster Apis Mellifera, Baptisia Tinctoria, Silybum Marianum Seed, Herring Sperm DNA, Echinacea, Galium Aparine, Mercuric Chloride, Mercuric Sulfide, Nitric Acid, Sulfur Iodide, and Thuja Occidentalis Leafy Twig SPRAY ORAL 20131113 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC APIS MELLIFERA; BAPTISIA TINCTORIA; SILYBUM MARIANUM SEED OIL; HERRING SPERM DNA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG 200; 3; 1.5; 3; 3; 1.5; 200; 30; 30; 200; 200 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 27281-007_fae27ff5-6400-440f-80b1-2dc419554f45 27281-007 HUMAN OTC DRUG Diabetigen Arnica Montana, Arsenic Trioxide, Herring Sperm NDA, Echinacea, Unspecified, Hamamelis Virginiana Leaf, Chamaelirium Luteum Root, Pork Liver, Iris Versicolor Root, Sus Scrofa Pancreas, Phosphoric Acid, Rosmarinus Officinalis Flowering Top, Claviceps Purpurea Sclerotium, Syzygium Cumini Seed, and Uranyl Nitrate Hexahydrate SPRAY ORAL 20131209 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC ARNICA MONTANA; ARSENIC TRIOXIDE; HERRING SPERM DNA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA LEAF; CHAMAELIRIUM LUTEUM ROOT; PORK LIVER; IRIS VERSICOLOR ROOT; SUS SCROFA PANCREAS; PHOSPHORIC ACID; ROSMARINUS OFFICINALIS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 1.5; 200; 3; 1.5; 1.5; 1.5; 3; 3; 3; 200; 1.5; 30; 1.5; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 27281-008_d9eb64ba-73ce-4440-9bb8-c2393b77640c 27281-008 HUMAN OTC DRUG Heartery American Ginseng, Arnica Montana, Gold, Barium Carbonate, Atropa Belladonna, Calcium Fluoride, Cholesterol, Herring Sperm DNA, Ginkgo, Saccharomyces Cerevisia RNA, Visbum Album Fruiting Top, and Ginger SPRAY ORAL 20131209 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC AMERICAN GINSENG; ARNICA MONTANA; GOLD; BARIUM CARBONATE; ATROPA BELLADONNA; CALCIUM FLUORIDE; CHOLESTEROL; HERRING SPERM DNA; GINKGO; SACCHAROMYCES CEREVISIAE RNA; VISCUM ALBUM FRUITING TOP; GINGER 1; 1.5; 30; 30; 3; 6; 15; 3; 3; 3; 1.5; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 27281-009_05bde5a5-d4c6-4783-860e-95afbbd19ca8 27281-009 HUMAN OTC DRUG Female Energy Chaste Tree, Arnica Montana, Caulophyllum Thalictroides Root, Cinchona Officinalis Bark, Turnera Diffusa Leafy Twig, Herring Sperm DNA, Lactuca Virosa, Onosmodium Virginianum Whole, Sus Scrofa Ovary, Phosphoric Acid, Sus Scrofa Pituitary Gland, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig SPRAY ORAL 20140807 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC CHASTE TREE; ARNICA MONTANA; CAULOPHYLLUM THALICTROIDES ROOT; CINCHONA OFFICINALIS BARK; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; LACTUCA VIROSA; ONOSMODIUM VIRGINIANUM WHOLE; SUS SCROFA OVARY; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 1.5; 1.5; 3; 1.5; .5; 3; 1.5; 30; 30; 200; 6; 30; 30 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg E 20171231 27281-010_f7d294c4-23f8-488a-b795-d65ec1391cd7 27281-010 HUMAN OTC DRUG Male Tonicity american ginseng, arnica montana, turnera diffusa leafy twig, herring sperm DNA, galium aparine, hamamelis virginiana root bark/stem bark, pork liver, cervus elaphus horn oil, ovis aries testicle, phosphoric acid, sus scrofa pituitary gland, thuja occidentalis leafy twig, thyroid, unspecified, tribulus terrestris, ginger SPRAY ORAL 20140808 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC AMERICAN GINSENG; ARNICA MONTANA; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; CERVUS ELAPHUS HORN OIL; OVIS ARIES TESTICLE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIBULUS TERRESTRIS; GINGER 1.5; 1.5; 1; 3; 1.5; 1.5; 3; 4; 3; 200; 4; 1.5; 6; 1; 1.5 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg E 20171231 27281-011_08a08c96-5fe1-4414-8c60-a839f8762639 27281-011 HUMAN OTC DRUG Lung Detox silver nitrate, arsenic trioxide, activated charcoal, silybum marianum seed, herring sperm DNA, pork liver, mercuric chloride, lead SPRAY ORAL 20140808 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC SILVER NITRATE; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; SILYBUM MARIANUM SEED; HERRING SPERM DNA; PORK LIVER; MERCURIC CHLORIDE; LEAD 200; 200; 200; .5; 3; 3; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg E 20171231 27281-029_ed692e89-82e3-4743-8d2e-d2619b69f2d5 27281-029 HUMAN OTC DRUG Livergen Arnica montana, Bryonia, Carduus marianus, Chelidonium majus, DNA, Hepar suis, Oleum animale, Pancreas suis, Taraxacum officinale. LIQUID ORAL 20131113 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC ARNICA MONTANA; BRYONIA ALBA ROOT; MILK THISTLE; CHELIDONIUM MAJUS; HERRING SPERM DNA; PORK LIVER; CERVUS ELAPHUS HORN OIL; SUS SCROFA PANCREAS; TARAXACUM OFFICINALE 3; 200; 1; 200; 6; 6; 8; 8; 2 [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 27281-049_6670df52-e3b2-4716-b97e-925a6f1044da 27281-049 HUMAN OTC DRUG Immune Booster Apis mellifica, Baptisia tinctoria, Carduus marianus, Echinacea angustifolia, Gallum aparine, Mercurius corrosivus, Mercurius sulphuratus ruber, Nitricum acidum, Sulphur iodatum, Thuja occidentalis. LIQUID ORAL 20131113 UNAPPROVED HOMEOPATHIC Sunway Biotech LLC APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; MILK THISTLE; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG 200; 6; 3; 6; 3; 200; 30; 30; 200; 200 [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL N 20181231 27293-012_6e9a3eb8-fa5b-4c54-a0c0-24fe205b4e23 27293-012 HUMAN OTC DRUG Oral Gel Maximum Strength Benzocaine GEL TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part356 Budpak Inc. BENZOCAINE 20 g/100g E 20171231 27293-013_19366a07-9784-4435-b83b-4882399e3f7b 27293-013 HUMAN OTC DRUG Baby Teething Oral Pain Reliever Benzocaine GEL TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part356 Budpak Inc. BENZOCAINE 7.5 g/100g E 20171231 27293-014_1feefbdd-7a58-4862-a59b-a3263051e67d 27293-014 HUMAN OTC DRUG Triple Antibiotic Maximum Strength Bacitracin Zinc Neomycin Polymyxin B Sulfate OINTMENT TOPICAL 20110819 OTC MONOGRAPH FINAL part333B Budpak Inc. BACITRACIN ZINC; NEOMYCIN; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g E 20171231 27293-015_b9acba3e-b0e4-483c-b273-e05c674499e9 27293-015 HUMAN OTC DRUG Budpak Baby Teething Oral Pain Reliever Benzocaine GEL TOPICAL 20131226 OTC MONOGRAPH NOT FINAL part356 Budpak Inc. BENZOCAINE 7.5 g/100g N 20181231 27293-016_7f9aefd9-47cf-49cf-a1b2-b6a2b60695ea 27293-016 HUMAN OTC DRUG Budpak First Aid Lidocaine HCL and Phenol CREAM TOPICAL 20130612 OTC MONOGRAPH NOT FINAL part348 Budpak Inc. LIDOCAINE HYDROCHLORIDE; PHENOL .005; .005 g/g; g/g N 20181231 27293-017_1d91f27f-8cf0-4af1-a049-c74835d6859b 27293-017 HUMAN OTC DRUG BudPak Anti-Itch Hydrocortisone CREAM TOPICAL 20121217 OTC MONOGRAPH NOT FINAL part348 Budpak Inc. HYDROCORTISONE .01 g/g N 20181231 27293-018_a7f5887e-da34-4842-a601-9aa8e9a398af 27293-018 HUMAN OTC DRUG Budpak Muscle Rub Menthol GEL TOPICAL 20121217 OTC MONOGRAPH FINAL part348 Budpak Inc. MENTHOL .025 g/g N 20181231 27293-019_91a75546-e237-4970-a30c-6af048b0b011 27293-019 HUMAN OTC DRUG Budpak Oral Maximum Strength Benzocaine GEL TOPICAL 20130610 OTC MONOGRAPH NOT FINAL part356 Budpak Inc. BENZOCAINE .2 g/g N 20181231 27293-020_71d5322a-77bd-4bbb-a7be-0a4eb5f84756 27293-020 HUMAN OTC DRUG Budpack Feminine Anti-itch Benzocaine Benzalkonium chloride CREAM TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part348 Budpak Inc. BENZOCAINE; BENZALKONIUM CHLORIDE 5; 130 g/100g; mg/100g E 20171231 27293-022_2723f378-f50f-4606-b0b4-d6b33b7eddf2 27293-022 HUMAN OTC DRUG Budpak Feminine Anti-Itch Benzocaine and Resorcinol CREAM TOPICAL 20130610 OTC MONOGRAPH NOT FINAL part348 Budpak Inc. BENZOCAINE; RESORCINOL .05; .02 g/g; g/g N 20181231 27293-023_37440f2f-0bc8-4799-8a1e-514b8d86a388 27293-023 HUMAN OTC DRUG Budpak Antifungal Miconazole Nitrate Miconazole Nitrate CREAM TOPICAL 20131129 OTC MONOGRAPH FINAL part333C Budpak Inc. MICONAZOLE NITRATE .02 g/g N 20181231 27293-024_668371ff-a1b5-4818-896f-425890f542e3 27293-024 HUMAN OTC DRUG Budpak Triple Antibiotic Maximum Strength Bacitracin Zinc, Neomycin Sulfate and Polymyxin B Sulfate OINTMENT TOPICAL 20130610 OTC MONOGRAPH FINAL part333B Budpak Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 27293-025_4917ddf3-ebec-4149-b6d7-9fd4d59268b3 27293-025 HUMAN OTC DRUG Budpak Antifungal Clotrimazole Clotrimazole CREAM TOPICAL 20121217 OTC MONOGRAPH FINAL part333C Budpak Inc. CLOTRIMAZOLE .01 g/g N 20181231 27293-026_16ef05c6-c8e0-4de4-b4d3-43d408a0fd7b 27293-026 HUMAN OTC DRUG Budpak Hemorrhoid Anesthetic Mineral Oil, Petrolatum, Phenylephrine HCL OINTMENT TOPICAL 20130610 OTC MONOGRAPH FINAL part346 Budpak Inc. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE .14; .749; .0025 g/g; g/g; g/g N 20181231 27293-027_05ece84a-9c76-4fa6-a92c-85bcdf79546d 27293-027 HUMAN OTC DRUG Budpak Medicated Anti Itch Camphor and Menthol CREAM TOPICAL 20121217 OTC MONOGRAPH NOT FINAL part348 Budpak Inc. CAMPHOR (SYNTHETIC); MENTHOL .01; .01 g/g; g/g N 20181231 27293-028_985046ac-f4ae-4c7a-881d-c2491a3a0f6a 27293-028 HUMAN OTC DRUG Budpak Diaper Rash Zinc Oxide CREAM TOPICAL 20140214 OTC MONOGRAPH FINAL part347 Budpak Inc. ZINC OXIDE 13 g/100g N 20181231 27293-029_0db451f5-a019-431a-87db-8c5a59ba5d32 27293-029 HUMAN OTC DRUG Budpak Petroleum Cocoa Butter White Petrolatum JELLY TOPICAL 20140214 OTC MONOGRAPH FINAL part347 Budpak Inc. PETROLATUM 99.9 g/100g N 20181231 27293-030_b2cd9dd8-f8e2-4160-8366-bedb2f9dd25f 27293-030 HUMAN OTC DRUG Budpack Muscle Rub Menthol GEL TOPICAL 20120630 OTC MONOGRAPH NOT FINAL part348 Budpack Inc. MENTHOL 2.5 g/100g E 20171231 27293-033_838d36cc-e9c2-407c-ad94-e8c1cf482ebe 27293-033 HUMAN OTC DRUG Budpak Petroleum Petroleum JELLY TOPICAL 20140707 OTC MONOGRAPH FINAL part347 Budpak Inc. PETROLATUM 100 g/100g N 20181231 27293-035_1299b298-f18b-392e-e054-00144ff8d46c 27293-035 HUMAN OTC DRUG Budpak Bacitracin Bacitracin Zinc OINTMENT TOPICAL 20150330 OTC MONOGRAPH FINAL part333B Budpak Inc. BACITRACIN ZINC 500 [iU]/g N 20181231 27293-036_12c01d3d-a64c-396a-e054-00144ff8d46c 27293-036 HUMAN OTC DRUG Budpak Vitamin A and D Vitamin A and D CREAM TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part347 Budpak Inc. VITAMIN A; VITAMIN D 181.8; 1200 [iU]/g; [iU]/g N 20181231 27437-050_d527abf0-32dd-4187-814c-93d922f7d76b 27437-050 HUMAN PRESCRIPTION DRUG Methergine Methylergonovine maleate TABLET ORAL 20160404 ANDA ANDA091577 Lupin Pharma METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] E 20171231 27437-051_b704f87b-1c40-4775-ae50-df0fccb046a0 27437-051 HUMAN PRESCRIPTION DRUG solosec secnidazole GRANULE ORAL 20171030 NDA NDA209363 LUPIN PHARMA SECNIDAZOLE 2 g/4.8g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 27437-106_5d7a544d-f20c-e58d-e053-2991aa0aeca4 27437-106 HUMAN PRESCRIPTION DRUG Alinia nitazoxanide POWDER, FOR SUSPENSION ORAL 20131009 20180731 NDA NDA021498 Lupin Pharma NITAZOXANIDE 100 mg/5mL Antiprotozoal [EPC] N 20181231 27437-107_f83c4ff6-1491-4880-aacb-a013461ba9a3 27437-107 HUMAN PRESCRIPTION DRUG Antara fenofibrate CAPSULE ORAL 20131101 NDA NDA021695 LUPIN PHARMA FENOFIBRATE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 27437-108_f83c4ff6-1491-4880-aacb-a013461ba9a3 27437-108 HUMAN PRESCRIPTION DRUG Antara fenofibrate CAPSULE ORAL 20131101 NDA NDA021695 LUPIN PHARMA FENOFIBRATE 90 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 27437-109_ab9237aa-f900-4522-9762-c7159e722b24 27437-109 HUMAN PRESCRIPTION DRUG ANTARA FENOFIBRATE CAPSULE ORAL 20090925 NDA NDA021695 LUPIN PHARMA FENOFIBRATE 43 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 27437-110_ab9237aa-f900-4522-9762-c7159e722b24 27437-110 HUMAN PRESCRIPTION DRUG ANTARA FENOFIBRATE CAPSULE ORAL 20090925 NDA NDA021695 LUPIN PHARMA FENOFIBRATE 130 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 27437-143_dbdc8273-3224-4557-b509-f3cf8ce6ccf8 27437-143 HUMAN PRESCRIPTION DRUG AllerNaze Triamcinolone Acetonide SPRAY, METERED NASAL 20110201 NDA NDA020120 Lupin Pharmaceuticals TRIAMCINOLONE ACETONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 27437-201_22f3e77a-8ffd-4647-bfe9-b190738bd289 27437-201 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET ORAL 20080401 ANDA ANDA065130 LUPIN PHARMA CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 27437-203_22f3e77a-8ffd-4647-bfe9-b190738bd289 27437-203 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET, CHEWABLE ORAL 20121205 ANDA ANDA065380 LUPIN PHARMA CEFIXIME 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 27437-205_22f3e77a-8ffd-4647-bfe9-b190738bd289 27437-205 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET, CHEWABLE ORAL 20121205 ANDA ANDA065380 LUPIN PHARMA CEFIXIME 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 27437-206_22f3e77a-8ffd-4647-bfe9-b190738bd289 27437-206 HUMAN PRESCRIPTION DRUG SUPRAX cefixime POWDER, FOR SUSPENSION ORAL 20070601 ANDA ANDA065355 LUPIN PHARMA CEFIXIME 200 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 27437-207_22f3e77a-8ffd-4647-bfe9-b190738bd289 27437-207 HUMAN PRESCRIPTION DRUG SUPRAX cefixime POWDER, FOR SUSPENSION ORAL 20130315 NDA NDA202091 LUPIN PHARMA CEFIXIME 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 27437-208_22f3e77a-8ffd-4647-bfe9-b190738bd289 27437-208 HUMAN PRESCRIPTION DRUG SUPRAX cefixime CAPSULE ORAL 20130315 NDA NDA203195 LUPIN PHARMA CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 27437-298_6a2c635d-32d1-4b42-b258-b0d83305ddd9 27437-298 HUMAN PRESCRIPTION DRUG Irenka Duloxetine CAPSULE, DELAYED RELEASE ORAL 20150601 ANDA ANDA090694 LUPIN PHARMA DULOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 27495-006_77199c68-4209-4ffa-84f0-2ab0103dbce9 27495-006 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part348 Physicians Science & Nature Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 18; 6; .0225 mL/60mL; mL/60mL; mL/60mL N 20181231 27495-008_25fec070-8587-42d1-ba6f-1a9c150acc98 27495-008 HUMAN OTC DRUG Overtime Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part348 Physicians Science & Nature Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 18; 6; .0225 mL/60mL; mL/60mL; mL/60mL N 20181231 27495-010_a08ffd2b-6c78-4a1a-9ca4-08a72900119d 27495-010 HUMAN OTC DRUG ProCoMycin Bacitracin, Neomycin, Polymyxin B and Lidocain Hydrochloride CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part345 Physicians Science & Nature Inc. BACITRACIN; NEOMYCIN; POLYMYXIN B; LIDOCAINE HYDROCHLORIDE 500; .0035; 10000; .04 [iU]/g; g/g; [iU]/g; g/g N 20181231 27495-012_5f259962-fe9d-7d47-e053-2a91aa0ad462 27495-012 HUMAN OTC DRUG Promolaxin Docusate sodium TABLET ORAL 20110415 OTC MONOGRAPH NOT FINAL part334 Physicians Science & Nature Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 27495-014_05742cd5-ece2-4007-bdf0-46b76d23df74 27495-014 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part348 Physicians Science & Nature Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 18; 6; .015 mL/60mL; mL/60mL; mL/60mL N 20181231 27495-018_14b76eca-29f6-4dbd-890b-f72865877ad3 27495-018 HUMAN OTC DRUG Transanosil Methyl Salicylate, Menthol, and Capsaicin LOTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Physicians Science & Nature Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 30; 10; .025 g/100mL; g/100mL; g/100mL N 20181231 27495-019_50f35a6a-982a-4cf8-a371-f66162308d98 27495-019 HUMAN OTC DRUG OVERTIME-X Methyl Salicylate, Menthol, Capsaicin LOTION TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part348 Physician’s Science & Nature Inc. METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAPSAICIN 30; 10; .025 g/100mL; g/100mL; g/100mL N 20181231 27505-003_5c0aa9d6-f52a-470d-acca-0362beb43762 27505-003 HUMAN PRESCRIPTION DRUG Revonto dantrolene sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120604 ANDA ANDA078378 US WorldMeds, LLC DANTROLENE SODIUM 20 mg/60mL Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 27505-004_f4356cec-5223-42f2-b26e-c736ec2c308a 27505-004 HUMAN PRESCRIPTION DRUG APOKYN APOMORPHINE HYDROCHLORIDE INJECTION SUBCUTANEOUS 20040702 NDA NDA021264 US WorldMeds, LLC APOMORPHINE HYDROCHLORIDE 30 mg/3mL Dopamine Agonists [MoA],Dopaminergic Agonist [EPC] N 20181231 27505-100_98046738-6458-4b93-8549-c1b58f23de6b 27505-100 HUMAN PRESCRIPTION DRUG Corgard nadolol TABLET ORAL 20160401 NDA NDA018063 US WorldMeds, LLC NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 27505-101_98046738-6458-4b93-8549-c1b58f23de6b 27505-101 HUMAN PRESCRIPTION DRUG Corgard nadolol TABLET ORAL 20160401 NDA NDA018063 US WorldMeds, LLC NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 27505-102_98046738-6458-4b93-8549-c1b58f23de6b 27505-102 HUMAN PRESCRIPTION DRUG Corgard nadolol TABLET ORAL 20160401 NDA NDA018063 US WorldMeds, LLC NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 27505-110_734de98d-6229-48bd-bde5-480294497235 27505-110 HUMAN PRESCRIPTION DRUG Xadago safinamide mesylate TABLET, FILM COATED ORAL 20170508 NDA NDA207145 US WorldMeds, LLC SAFINAMIDE MESYLATE 50 mg/1 Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 27505-111_734de98d-6229-48bd-bde5-480294497235 27505-111 HUMAN PRESCRIPTION DRUG Xadago safinamide mesylate TABLET, FILM COATED ORAL 20170508 NDA NDA207145 US WorldMeds, LLC SAFINAMIDE MESYLATE 100 mg/1 Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 27789-911_d92d370f-3f7f-4b8f-8a6e-99b9920e5c17 27789-911 HUMAN OTC DRUG Zcaine Fast Acting Anesthetic LIDOCAINE GEL TOPICAL 20120404 OTC MONOGRAPH FINAL part348 PHI, Inc LIDOCAINE 4 g/100g N 20181231 27808-033_15ed2eaa-e627-4e15-b098-686f02466602 27808-033 HUMAN PRESCRIPTION DRUG Theophylline Theophylline SOLUTION ORAL 20120802 ANDA ANDA091586 Tris Pharma Inc THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 27808-035_d495f7ea-05bc-4779-b304-2c21899f1eec 27808-035 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA202214 Tris Pharma Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 27808-036_d495f7ea-05bc-4779-b304-2c21899f1eec 27808-036 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA202214 Tris Pharma Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 27808-037_d495f7ea-05bc-4779-b304-2c21899f1eec 27808-037 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA202214 Tris Pharma Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 27808-051_c73a0c40-fa54-41f6-83c1-72ad839934b7 27808-051 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 20120803 ANDA ANDA091675 Tris Pharma Inc PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 27808-058_55749f6c-e61d-4f84-a842-a6b37e87e90a 27808-058 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20150304 ANDA ANDA091601 Tris Pharma Inc METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 27808-059_55749f6c-e61d-4f84-a842-a6b37e87e90a 27808-059 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20150304 ANDA ANDA091601 Tris Pharma Inc METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 27808-082_3b32f459-9754-42cb-8c39-3ed7cf46bfd4 27808-082 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20150921 ANDA ANDA203518 Tris Pharma Inc MORPHINE SULFATE 20 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 27808-083_ff16183e-73e4-4c84-b82b-dc33054b5e27 27808-083 HUMAN PRESCRIPTION DRUG Morphine sulfate solution Morphine sulfate SOLUTION ORAL 20170615 ANDA ANDA203519 Tris Pharma Inc MORPHINE SULFATE 20 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 27808-084_3b32f459-9754-42cb-8c39-3ed7cf46bfd4 27808-084 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20150921 ANDA ANDA203518 Tris Pharma Inc MORPHINE SULFATE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 27808-085_f35f9661-9066-4298-8aa2-2e16bb187066 27808-085 HUMAN PRESCRIPTION DRUG Dextroamphetamine Dextroamphetamine SOLUTION ORAL 20130531 ANDA ANDA203644 Tris Pharma Inc DEXTROAMPHETAMINE SULFATE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 27808-086_ce1ffc06-5ed5-4eaf-b432-6ce6397d7505 27808-086 HUMAN PRESCRIPTION DRUG Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release Hydrocodone Polistirex and Chlorpheniramine Polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150306 ANDA ANDA091632 Tris Pharma Inc HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE 10; 8 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII N 20181231 27808-091_b6c485a1-af2b-4016-8729-f12e02231277 27808-091 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20161001 ANDA ANDA207901 Tris Pharma Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 27808-092_b6c485a1-af2b-4016-8729-f12e02231277 27808-092 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20161001 ANDA ANDA207901 Tris Pharma Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 27808-093_b6c485a1-af2b-4016-8729-f12e02231277 27808-093 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20161001 ANDA ANDA207901 Tris Pharma Inc DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 27808-102_4b80fde6-331f-4ac9-a21a-1ea0f7213de2 27808-102 HUMAN PRESCRIPTION DRUG Dyanavel XR amphetamine SUSPENSION, EXTENDED RELEASE ORAL 20151001 NDA NDA208147 Tris Pharma Inc AMPHETAMINE 2.5 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 27808-114_30094e04-8a78-4288-ba86-293d12da8a88 27808-114 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen Tablets TABLET ORAL 20160407 ANDA ANDA202214 Tris Pharma Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 27808-115_30094e04-8a78-4288-ba86-293d12da8a88 27808-115 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160407 ANDA ANDA202214 Tris Pharma Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 27808-116_30094e04-8a78-4288-ba86-293d12da8a88 27808-116 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160407 ANDA ANDA202214 Tris Pharma Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 27808-155_ea4fa963-4ac9-48e0-8653-2288e7c978c0 27808-155 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20180108 ANDA ANDA207408 Tris Pharma Inc ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 27808-156_ea4fa963-4ac9-48e0-8653-2288e7c978c0 27808-156 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20180108 ANDA ANDA207408 Tris Pharma Inc ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 27808-157_ea4fa963-4ac9-48e0-8653-2288e7c978c0 27808-157 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20180108 ANDA ANDA207408 Tris Pharma Inc ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 27808-158_ea4fa963-4ac9-48e0-8653-2288e7c978c0 27808-158 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20180108 ANDA ANDA207408 Tris Pharma Inc ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 27854-100_45a544ae-2779-407a-833b-d8a52b38fe8c 27854-100 HUMAN OTC DRUG Flanax Methyl Salicylate, Menthol, and Capsicum Oleoresin LINIMENT TOPICAL 20121206 20181001 OTC MONOGRAPH NOT FINAL part348 Belmora LLC METHYL SALICYLATE; MENTHOL; CAPSICUM OLEORESIN 13.8; 6; .014 g/60mL; g/60mL; g/60mL N 20181231 27854-103_0967fe13-d1e7-4962-89f3-0ba5b82b76d0 27854-103 HUMAN OTC DRUG Flanax Pain Reliever Naproxen Sodium TABLET ORAL 20081216 ANDA ANDA079096 Belmora LLC NAPROXEN SODIUM 220 mg/1 N 20181231 27854-112_60b57724-03a8-a364-e053-2a91aa0ac5f2 27854-112 HUMAN OTC DRUG FLANAX Antacid Anti-gas aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 20160830 OTC MONOGRAPH FINAL part331 Belmora LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 27854-160_b20b8456-fffa-499c-80e3-86bf4cee5e5d 27854-160 HUMAN OTC DRUG Flanax Naproxen Sodium TABLET, COATED ORAL 20180115 ANDA ANDA204872 Belmora LLC NAPROXEN SODIUM 220 mg/1 N 20181231 27854-190_2e9d3a40-1333-471d-b675-2318f0d50002 27854-190 HUMAN PRESCRIPTION DRUG Flanax Naproxen naproxen TABLET ORAL 20150818 ANDA ANDA075927 Belmora LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 27854-205_757480bd-fa0b-4090-a3fe-310311e64b88 27854-205 HUMAN OTC DRUG Flanax Capsaicin, Menthol, Methyl Salicylate LINIMENT TOPICAL 20161027 OTC MONOGRAPH NOT FINAL part348 Belmora LLC CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .025; 10; 23 g/100mL; g/100mL; g/100mL E 20171231 28064-056_aa4c5d83-8ef9-4a9a-b164-9a14b68f4ee0 28064-056 HUMAN OTC DRUG Instant Hand Sanitizer Instant Hand Sanitizer SOLUTION TOPICAL 20131105 OTC MONOGRAPH NOT FINAL part333A Knight Facilities Management, Inc. ALCOHOL 62 mL/100mL E 20171231 28064-515_9c91cc75-b82a-4b33-8221-9551c1a91ad6 28064-515 HUMAN OTC DRUG Facility Maintenance Instant Hand Sanitizer HS-67 ALCOHOL GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Knight Facilities Management, Inc. ALCOHOL 600 mL/1000mL E 20171231 28105-421_676f11b2-e913-40c7-ae42-d1aae73f0c2a 28105-421 HUMAN PRESCRIPTION DRUG TOLAK FLUOROURACIL CREAM TOPICAL 20150918 20190228 NDA NDA022259 HILL DERMACEUTICALS, INC. FLUOROURACIL .04 g/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 28107-002_f7af3c71-1a86-4bdb-9714-3f1b227adeb8 28107-002 HUMAN OTC DRUG CleanWell Natural Original Hand Sanitizer Wipes CleanWell Natural Original Hand Sanitizer Wipes CLOTH TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0005 kg/kg E 20171231 28107-003_d5863fd1-ae47-44c7-a51e-74f4582b7908 28107-003 HUMAN OTC DRUG Ginger Bergamot Natural Antibacterial Foaming Ginger Bergamot Natural Antibacterial Foaming SOAP TOPICAL 20071101 20190529 OTC MONOGRAPH NOT FINAL part356 CleanWell, LLC THYMOL .0004 kg/kg N 20181231 28107-004_cd3ba6d7-6f2a-49d9-a17f-f298a785c488 28107-004 HUMAN OTC DRUG CleanWell Natural Antibacterial Foaming Orange Vanilla CleanWell Natural Antibacterial Foaming Orange Vanilla SOAP TOPICAL 20071101 20190529 OTC MONOGRAPH NOT FINAL part356 CleanWell, LLC THYMOL .0004 1/kg N 20181231 28107-005_db083514-da05-42e4-89ba-76fb7e50edbe 28107-005 HUMAN OTC DRUG CLEANWELL NATURAL ANTIBACTERIAL FOAMING LAVENDER CLEANWELL NATURAL ANTIBACTERIAL FOAMING LAVENDER SOAP TOPICAL 20071101 20190529 OTC MONOGRAPH NOT FINAL part356 CleanWell, LLC THYMOL .0004 kg/kg N 20181231 28107-006_0566efd1-d393-4c2f-af37-ce69b2d5a9ae 28107-006 HUMAN OTC DRUG CleanWell Natural Antibacterial Foaming Spearmint Lime CleanWell Natural Antibacterial Foaming Spearmint Lime SOAP TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0004 kg/kg E 20171231 28107-007_b5dd246d-86d9-4303-9d58-ea521f0601a3 28107-007 HUMAN OTC DRUG CleanWell Natural Orange Vanilla Hand Sanitizing Wipes CleanWell Natural Orange Vanilla Hand Sanitizing Wipes CLOTH TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0005 kg/kg E 20171231 28107-008_7dc09386-5e2b-4b3a-8353-65f207fd854d 28107-008 HUMAN OTC DRUG CleanWell Natural Orange Vanilla Hand Sanitizer CleanWell Natural Orange Vanilla Hand Sanitizer SPRAY TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0005 kg/kg E 20171231 28107-009_0e649a81-48cc-412f-9857-3144b5201391 28107-009 HUMAN OTC DRUG Natures Antibac Orange Vanilla Natures Antibac Orange Vanilla SOAP TOPICAL 20120201 20190529 OTC MONOGRAPH NOT FINAL part356 CleanWell, LLC THYMOL .0024 kg/kg N 20181231 28107-010_c2d4d2c6-de7e-413f-8774-332082967ad8 28107-010 HUMAN OTC DRUG Natures Antibac Peppermint Natures Antibac Peppermint SOAP TOPICAL 20120201 20190529 OTC MONOGRAPH NOT FINAL part356 CleanWell, LLC THYMOL .0024 kg/kg N 20181231 28107-011_56115b9c-78a6-42e5-88a4-a415db109b17 28107-011 HUMAN OTC DRUG Natures Antibac Lavender Natures Antibac Lavender SOAP TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part356 CleanWell THYMOL .0024 kg/kg E 20171231 28109-010_43c8f760-7c5c-407c-91ce-674bd13b4ecd 28109-010 HUMAN OTC DRUG AcneWorx salicylic acid GEL TOPICAL 20080114 OTC MONOGRAPH FINAL part333 DermWorx Incorporated SALICYLIC ACID .6 g/30mL E 20171231 28109-020_e627fee6-666a-4bb0-b0a1-cb6e94df03ee 28109-020 HUMAN OTC DRUG MoistureWorx petrolatum SPRAY TOPICAL 20080527 OTC MONOGRAPH FINAL part347 DermWorx Incorporated PETROLATUM 36 mL/120mL E 20171231 28475-810_43824b60-0dbd-47c9-b1ed-8cf4dc94eff0 28475-810 HUMAN OTC DRUG PrevinC LEMON SOLUTION NASAL 20101010 UNAPPROVED HOMEOPATHIC BioHealth Technologies Inc. LEMON 1 [hp_X]/5mL E 20171231 28595-250_be02ff98-00db-43f9-b383-5e510ebb15d7 28595-250 HUMAN OTC DRUG HISTEX AC CODEINE PHOSPHATE, PHENYLEPHRINE HYDROCHLORIDE, and TRIPROLIDINE HYDROCHLORIDE SYRUP ORAL 20150812 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 10; 10; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 28595-300_be486bc9-6a4f-4c41-8ca9-a2899edbd743 28595-300 HUMAN OTC DRUG Brohist D Brompheniramine Maleate and Phenylephrine Hydrochloride TABLET, COATED ORAL 20120910 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 28595-570_29c217d7-2795-4ed8-878c-9026bd2a6ee8 28595-570 HUMAN PRESCRIPTION DRUG Spinosad spinosad SUSPENSION TOPICAL 20140625 NDA NDA022408 Allegis Pharmaceuticals, LLC SPINOSAD 9 mg/mL Pediculicide [EPC] N 20181231 28595-780_52cf1494-9ab8-4ed1-9061-5d192c204846 28595-780 HUMAN OTC DRUG HistaFlex ACETAMINOPHEN and PYRILAMINE MALEATE TABLET ORAL 20140522 OTC MONOGRAPH NOT FINAL part343 Allegis Pharmaceuticals, LLC ACETAMINOPHEN; PYRILAMINE MALEATE 325; 25 mg/1; mg/1 N 20181231 28595-800_aa07b430-abc9-492f-818b-9fa94c5f7490 28595-800 HUMAN OTC DRUG AP-Hist DM Brompheniramine Maleate, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide LIQUID ORAL 20130415 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 4; 7.5; 15 mg/mL; mg/mL; mg/mL E 20171231 28595-801_41079447-f4b9-4da6-8ed2-f6810eb2346f 28595-801 HUMAN OTC DRUG HISTEX PD Drops TRIPROLIDINE HYDROCHLORIDE SYRUP ORAL 20140306 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC TRIPROLIDINE HYDROCHLORIDE .938 mg/mL N 20181231 28595-802_d54fba80-fcd0-4fc5-9870-1e3e6e7b51ea 28595-802 HUMAN OTC DRUG HISTEX TRIPROLIDINE HYDROCHLORIDE SYRUP ORAL 20140304 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC TRIPROLIDINE HYDROCHLORIDE 2.5 mg/5mL N 20181231 28595-803_660edee9-4a95-4a0b-b951-c5283293c626 28595-803 HUMAN OTC DRUG HISTEX-PE PHENYLEPHRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORIDE SYRUP ORAL 20140317 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 10; 2.5 mg/5mL; mg/5mL N 20181231 28595-804_ac2157ef-390a-4c6d-a304-9e78aae1294d 28595-804 HUMAN OTC DRUG HISTEX-DM DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and TRIPROLIDINE HYDROCHLORIDE SYRUP ORAL 20140319 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 20; 10; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 28595-805_145e5e82-705c-499d-8bf6-863858e2d8f0 28595-805 HUMAN OTC DRUG HISTEX TRIPROLIDINE HYDROCHLORIDE TABLET, CHEWABLE ORAL 20170724 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC TRIPROLIDINE HYDROCHLORIDE 1.25 mg/1 N 20181231 28595-808_612ad2c9-4453-459c-97f6-8565e36b96c9 28595-808 HUMAN OTC DRUG HISTEX PDX Drops TRIPROLIDINE HYDROCHLORIDE SYRUP ORAL 20170622 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC TRIPROLIDINE HYDROCHLORIDE 1.25 mg/mL N 20181231 28595-900_7dcb52dc-f40f-4c24-b866-5d18ef4f3e2c 28595-900 HUMAN OTC DRUG Ru-Hist D Brompheniramine Maleate and Phenylephrine Hydrochloride TABLET, COATED ORAL 20131101 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 28595-905_a8aa7148-a219-4c68-895c-b3753d730526 28595-905 HUMAN OTC DRUG Duravent PE GUAIFENESIN and PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20140227 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 395; 10 mg/1; mg/1 N 20181231 28595-906_505ea130-06ab-47a3-8dde-60987f5089b6 28595-906 HUMAN OTC DRUG Duravent DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20140227 OTC MONOGRAPH FINAL part341 Allegis Pharmaceuticals, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 395; 10 mg/1; mg/1; mg/1 N 20181231 28623-250_59e56496-8403-491a-942c-dfd42cbfa5f7 28623-250 HUMAN OTC DRUG Cough and Cold XL3 Xtra Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130301 OTC MONOGRAPH FINAL part341 Progela, S.A. de C.V. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 250; 5; 2; 10 mg/1; mg/1; mg/1; mg/1 N 20181231 28691-0010_627b6e8e-06f5-4838-bd9f-88c3c730efc5 28691-0010 HUMAN OTC DRUG Antiseptic Bandages Benzalkonium chloride DRESSING TOPICAL 20161007 OTC MONOGRAPH NOT FINAL part333E Pharmaplast SAE BENZALKONIUM CHLORIDE .1 mg/100mg N 20181231 28691-0025_efb3a7b3-935a-47e9-8ee4-bf883d47210c 28691-0025 HUMAN OTC DRUG Capsaicin Capsaicin PATCH TOPICAL 20140111 OTC MONOGRAPH NOT FINAL part348 Pharmaplast SAE CAPSAICIN .6 mg/1 N 20181231 28691-0400_f6ea791c-ddb4-4b13-8fd3-adb2ce7f4b1b 28691-0400 HUMAN OTC DRUG Wart Remover Salicylic Acid PLASTER TOPICAL 20161007 OTC MONOGRAPH FINAL part358B Pharmaplast SAE SALICYLIC ACID .4 g/1 N 20181231 28691-0838_0cdf38fc-3f3b-4c50-8e7f-628f825f33c3 28691-0838 HUMAN OTC DRUG Wart Remover Salicylic Acid PLASTER TOPICAL 20100901 OTC MONOGRAPH FINAL part358B Pharmaplast SAE SALICYLIC ACID 40 mL/1 E 20171231 28691-1000_ddc7ae76-3c15-4fde-bca2-54e49a901896 28691-1000 HUMAN OTC DRUG Cure-Aid POVI Adhesive Bandage Povidone Iodine PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part333C Pharmaplast SAE POVIDONE-IODINE 100 mg/1 N 20181231 28691-1010_f3510d60-9a34-48b4-ba9b-6a286bc2d406 28691-1010 HUMAN OTC DRUG Kemagel Pain Relief Menthol GEL TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part348 Pharmaplast SAE MENTHOL, UNSPECIFIED FORM 10 g/100g N 20181231 28691-2500_78cc9679-bf91-475a-98fe-39dbebb5e92a 28691-2500 HUMAN OTC DRUG UNNAPLAST Zinc Oxide PASTE TOPICAL 20140101 OTC MONOGRAPH FINAL part347 Pharmaplast SAE ZINC OXIDE 5 mg/cm2 N 20181231 28691-2501_431da23b-3183-4fe3-ba7c-d60edae803c6 28691-2501 HUMAN OTC DRUG UNNAPLAST with CALAMINE Zinc Oxide and Calamine PASTE TOPICAL 20140101 OTC MONOGRAPH FINAL part347 Pharmaplast SAE ZINC OXIDE; FERRIC OXIDE RED 5; .2 mg/cm2; mg/cm2 N 20181231 28691-4000_8042f162-d747-41aa-b305-19184c0b4653 28691-4000 HUMAN OTC DRUG Cure-Aid Corn Plasters Salicylic acid PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358B Pharmaplast SAE SALICYLIC ACID 40 mg/1 N 20181231 28691-7000_b87cddd9-5c5e-4c33-a95b-8801b6c1eb2a 28691-7000 HUMAN OTC DRUG Alcohol swab Isopropyl Alcohol SWAB TOPICAL 20161007 OTC MONOGRAPH NOT FINAL part333A Pharmaplast SAE ISOPROPYL ALCOHOL .7 mL/mL N 20181231 28851-690_6fb36050-9f40-461c-87e0-48a3603b4339 28851-690 HUMAN OTC DRUG Kendall 2-in-1 Cleanser Dimethicone LIQUID TOPICAL 20110405 OTC MONOGRAPH FINAL part347 Covidien Inc. DIMETHICONE 1.5 mL/100mL E 20171231 28851-691_dfd328d2-3c26-4e97-8a00-f0429bfaea4a 28851-691 HUMAN OTC DRUG Kendall Antimicrobial Cleanser Benzalkonium Chloride LIQUID TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A Covidien Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 28851-692_c12520f1-5f04-406a-b40e-7234ff61ee61 28851-692 HUMAN OTC DRUG Kendall Antifungal Miconazole nitrate CREAM TOPICAL 20110414 OTC MONOGRAPH FINAL part333C Covidien Inc. MICONAZOLE NITRATE 2 g/100g E 20171231 28851-693_ee8f1c36-5798-43d1-a48a-dec2563ce58b 28851-693 HUMAN OTC DRUG Kendall Moisture Barrier Dimethicone CREAM TOPICAL 20110421 OTC MONOGRAPH FINAL part347 Covidien Inc. DIMETHICONE 5 mL/100mL E 20171231 28851-694_c49f81d4-7fd5-4b90-a790-37c3ba8d1560 28851-694 HUMAN OTC DRUG Kendall Moisturizing Dimethicone LOTION TOPICAL 20110420 OTC MONOGRAPH FINAL part347 Covidien Inc. DIMETHICONE 1.5 mL/100mL E 20171231 28851-695_472d414c-1970-415f-b1ab-85bd657d6e74 28851-695 HUMAN OTC DRUG Kendall Soothing Zinc Oxide OINTMENT TOPICAL 20110422 OTC MONOGRAPH FINAL part347 Covidien Inc. ZINC OXIDE 10 mL/100mL E 20171231 29033-001_122a10ed-d5ad-4806-91b0-df50293c2c63 29033-001 HUMAN PRESCRIPTION DRUG Theophylline (Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20070601 20190930 ANDA ANDA040560 Nostrum Laboratories, Inc. THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 29033-002_122a10ed-d5ad-4806-91b0-df50293c2c63 29033-002 HUMAN PRESCRIPTION DRUG Theophylline (Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20070601 20190531 ANDA ANDA040560 Nostrum Laboratories, Inc. THEOPHYLLINE ANHYDROUS 600 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 29033-004_9ba97403-9d6b-4254-ba8e-b7b7cc15802e 29033-004 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20110520 20180930 ANDA ANDA076697 Nostrum Laboratories, Inc. CARBAMAZEPINE 300 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 29033-012_1325c1e0-0bca-41ec-b1c4-3cfa6968201f 29033-012 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20100105 20181031 ANDA ANDA074116 Nostrum Laboratories, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 29033-013_1325c1e0-0bca-41ec-b1c4-3cfa6968201f 29033-013 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20100105 20181031 ANDA ANDA074118 Nostrum Laboratories, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 29033-018_f967d166-5738-4b5f-89d5-c3223d2345dd 29033-018 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA076756 Nostrum Laboratories Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 29033-019_9ba97403-9d6b-4254-ba8e-b7b7cc15802e 29033-019 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20110520 20180930 ANDA ANDA076697 Nostrum Laboratories, Inc. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 29033-020_9ba97403-9d6b-4254-ba8e-b7b7cc15802e 29033-020 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20110520 20180930 ANDA ANDA076697 Nostrum Laboratories, Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 29033-021_f967d166-5738-4b5f-89d5-c3223d2345dd 29033-021 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA076756 Nostrum Laboratories Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 29033-026_f93235fe-4665-40b5-891c-9e9eec92ba91 29033-026 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20151026 ANDA ANDA203179 Nostrum Laboratories, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 29033-028_809d9764-0924-45d4-bc57-458e9cfc8211 29033-028 HUMAN PRESCRIPTION DRUG Pindolol Pindolol TABLET ORAL 20160201 ANDA ANDA205415 Nostrum Laboratories, Inc. PINDOLOL 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 29033-029_809d9764-0924-45d4-bc57-458e9cfc8211 29033-029 HUMAN PRESCRIPTION DRUG Pindolol Pindolol TABLET ORAL 20160201 ANDA ANDA205415 Nostrum Laboratories, Inc. PINDOLOL 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 29033-030_24e2f670-a120-4ac7-a32a-31cf70a6f07e 29033-030 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20160330 ANDA ANDA204691 Nostrum Laboratories, Inc. ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 29033-031_81f16d1f-2994-4765-a94b-25a39bf9d632 29033-031 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20180102 ANDA ANDA203832 Nostrum Laboratories, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 29033-032_81f16d1f-2994-4765-a94b-25a39bf9d632 29033-032 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20180102 ANDA ANDA203832 Nostrum Laboratories, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 29033-036_4f1d3dc1-e6d3-4a07-89bd-1d552f63ce10 29033-036 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20160509 ANDA ANDA203887 Nostrum Laboratories, Inc. DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 29033-037_4f1d3dc1-e6d3-4a07-89bd-1d552f63ce10 29033-037 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20160509 ANDA ANDA203887 Nostrum Laboratories, Inc. DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 29033-045_7e1f705f-884c-4d9f-abb0-9a6773172d7a 29033-045 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20170327 ANDA ANDA205468 Nostrum Laboratories, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 29033-046_7e1f705f-884c-4d9f-abb0-9a6773172d7a 29033-046 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20170327 ANDA ANDA205468 Nostrum Laboratories, Inc. VENLAFAXINE HYDROCHLORIDE 225 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 29033-207_d79286e8-19ae-4fd5-837f-075729700561 29033-207 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20170511 ANDA ANDA207237 Nostrum Laboratories, Inc. CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 29149-001_60dfb4b2-2e4c-4a3e-e053-2a91aa0a814a 29149-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20080801 NDA NDA206023 Landmark Healthcare, Inc. OXYGEN 990 mL/L N 20181231 29273-401_ca759393-7d6d-42f5-ba46-e16a5b77f022 29273-401 HUMAN PRESCRIPTION DRUG FloLipid Simvastatin SUSPENSION ORAL 20171101 NDA NDA206679 Salerno Pharmaceuticals Co. SIMVASTATIN 20 mg/5mL HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 29273-402_ca759393-7d6d-42f5-ba46-e16a5b77f022 29273-402 HUMAN PRESCRIPTION DRUG FloLipid Simvastatin SUSPENSION ORAL 20171101 NDA NDA206679 Salerno Pharmaceuticals Co. SIMVASTATIN 40 mg/5mL HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 29300-111_b7dbda5f-9601-4d30-b4e7-7c3b1416ca2f 29300-111 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 Unichem Pharmaceuticals (USA), Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 29300-112_b7dbda5f-9601-4d30-b4e7-7c3b1416ca2f 29300-112 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 Unichem Pharmaceuticals (USA), Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 29300-113_b7dbda5f-9601-4d30-b4e7-7c3b1416ca2f 29300-113 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 Unichem Pharmaceuticals (USA), Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 29300-114_b7dbda5f-9601-4d30-b4e7-7c3b1416ca2f 29300-114 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 Unichem Pharmaceuticals (USA), Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 29300-115_b902032c-72c9-4692-a313-d719625f1cc1 29300-115 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090162 Unichem Pharmaceuticals (USA), Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 29300-116_b902032c-72c9-4692-a313-d719625f1cc1 29300-116 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090162 Unichem Pharmaceuticals (USA), Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 29300-117_b902032c-72c9-4692-a313-d719625f1cc1 29300-117 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090162 Unichem Pharmaceuticals (USA), Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 29300-118_b902032c-72c9-4692-a313-d719625f1cc1 29300-118 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090162 Unichem Pharmaceuticals (USA), Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 29300-124_ffc8fd34-b7e2-49fe-aca9-f076e758bda6 29300-124 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Unichem Pharmaceuticals (USA), Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 29300-125_ffc8fd34-b7e2-49fe-aca9-f076e758bda6 29300-125 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Unichem Pharmaceuticals (USA), Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 29300-126_09728b16-9db8-4b4f-91a5-5b7e7597ad1b 29300-126 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20090921 ANDA ANDA078635 Unichem Pharmaceuticals (USA), Inc. BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 29300-127_09728b16-9db8-4b4f-91a5-5b7e7597ad1b 29300-127 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20090921 ANDA ANDA078635 Unichem Pharmaceuticals (USA), Inc. BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 29300-128_f0787d18-0ffa-4fe6-8089-b29b9fbe2322 29300-128 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20090702 ANDA ANDA040907 Unichem Pharmaceuticals (USA), Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 29300-129_f0787d18-0ffa-4fe6-8089-b29b9fbe2322 29300-129 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20090702 ANDA ANDA040907 Unichem Pharmaceuticals (USA), Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 29300-130_6f668a56-bfe7-4893-ad38-787cd55484f9 29300-130 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20100315 ANDA ANDA090510 Unichem Pharmaceuticals (USA), Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 29300-131_91a1ccb7-f6ad-4cd9-8f4e-436a0148f743 29300-131 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Unichem Pharmaceuticals (USA), Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] N 20181231 29300-132_91a1ccb7-f6ad-4cd9-8f4e-436a0148f743 29300-132 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Unichem Pharmaceuticals (USA), Inc. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] N 20181231 29300-133_214c8297-d4f7-49ad-9058-593d5cbfbc84 29300-133 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride TABLET ORAL 20101130 ANDA ANDA078680 Unichem Pharmaceuticals (USA), Inc. CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 29300-134_214c8297-d4f7-49ad-9058-593d5cbfbc84 29300-134 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride TABLET ORAL 20101130 ANDA ANDA078680 Unichem Pharmaceuticals (USA), Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 29300-135_29c511a8-93d8-4873-9ce5-4e3440ee4914 29300-135 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Unichem Pharmaceuticals (USA), Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 29300-136_29c511a8-93d8-4873-9ce5-4e3440ee4914 29300-136 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Unichem Pharmaceuticals (USA), Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 29300-137_29c511a8-93d8-4873-9ce5-4e3440ee4914 29300-137 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Unichem Pharmaceuticals (USA), Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 29300-138_fc91358b-f524-4a5f-a59d-fceec578f59d 29300-138 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Unichem Pharmaceuticals (USA), Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 29300-139_fc91358b-f524-4a5f-a59d-fceec578f59d 29300-139 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Unichem Pharmaceuticals (USA), Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 29300-140_fc91358b-f524-4a5f-a59d-fceec578f59d 29300-140 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Unichem Pharmaceuticals (USA), Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 29300-144_45728851-e68f-46ee-bbab-38e61ba68ac7 29300-144 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20151014 ANDA ANDA203030 Unichem Pharmaceuticals (USA), Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 29300-145_45728851-e68f-46ee-bbab-38e61ba68ac7 29300-145 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20151014 ANDA ANDA203030 Unichem Pharmaceuticals (USA), Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 29300-146_45728851-e68f-46ee-bbab-38e61ba68ac7 29300-146 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20151014 ANDA ANDA203030 Unichem Pharmaceuticals (USA), Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 29300-147_50edfc8a-419e-44de-bbef-b707ff990ea2 29300-147 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20160701 ANDA ANDA202674 Unichem Pharmaceuticals (USA), Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 29300-148_50edfc8a-419e-44de-bbef-b707ff990ea2 29300-148 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20160701 ANDA ANDA202674 Unichem Pharmaceuticals (USA), Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 29300-149_50edfc8a-419e-44de-bbef-b707ff990ea2 29300-149 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20160701 ANDA ANDA202674 Unichem Pharmaceuticals (USA), Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 29300-150_50edfc8a-419e-44de-bbef-b707ff990ea2 29300-150 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20160701 ANDA ANDA202674 Unichem Pharmaceuticals (USA), Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 29300-151_50edfc8a-419e-44de-bbef-b707ff990ea2 29300-151 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20160701 ANDA ANDA202674 Unichem Pharmaceuticals (USA), Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 29300-152_50edfc8a-419e-44de-bbef-b707ff990ea2 29300-152 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20160701 ANDA ANDA202674 Unichem Pharmaceuticals (USA), Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 29300-155_554e633a-ec10-4bac-ae69-13af9bb6466e 29300-155 HUMAN PRESCRIPTION DRUG Alfuzosin hydrochloride Alfuzosin hydrochloride TABLET, EXTENDED RELEASE ORAL 20160315 ANDA ANDA203192 Unichem Pharmaceuticals (USA), Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 29300-168_3d3e6e45-9bae-48e9-b49a-a4457541002e 29300-168 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130401 ANDA ANDA091283 Unichem Pharmaceuticals (USA), Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 29300-169_3d3e6e45-9bae-48e9-b49a-a4457541002e 29300-169 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130401 ANDA ANDA091283 Unichem Pharmaceuticals (USA), Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 29300-171_1397feb7-36be-453d-b09c-d64157a2a08d 29300-171 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine hydrochloride TABLET, FILM COATED ORAL 20151101 ANDA ANDA200022 Unichem Pharmaceuticals (USA), Inc. MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 29300-172_1397feb7-36be-453d-b09c-d64157a2a08d 29300-172 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine hydrochloride TABLET, FILM COATED ORAL 20151101 ANDA ANDA200022 Unichem Pharmaceuticals (USA), Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 29300-187_b84c78cf-9bde-4dd3-8577-77dd297a60ea 29300-187 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 Unichem Pharmaceuticals (USA), Inc. HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE 6.25; 2.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 29300-188_b84c78cf-9bde-4dd3-8577-77dd297a60ea 29300-188 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 Unichem Pharmaceuticals (USA), Inc. HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE 6.25; 5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 29300-189_b84c78cf-9bde-4dd3-8577-77dd297a60ea 29300-189 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 Unichem Pharmaceuticals (USA), Inc. HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE 6.25; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 29300-190_4dc2039c-940b-452b-a68c-e5247186f492 29300-190 HUMAN PRESCRIPTION DRUG losartan potassium and hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20170721 ANDA ANDA204832 Unichem Pharmaceuticals (USA), Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 29300-191_4dc2039c-940b-452b-a68c-e5247186f492 29300-191 HUMAN PRESCRIPTION DRUG losartan potassium and hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20170721 ANDA ANDA204832 Unichem Pharmaceuticals (USA), Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 29300-192_4dc2039c-940b-452b-a68c-e5247186f492 29300-192 HUMAN PRESCRIPTION DRUG losartan potassium and hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20170721 ANDA ANDA204832 Unichem Pharmaceuticals (USA), Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 29300-212_44c0216e-d1c3-4fd6-a745-017009e12919 29300-212 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20151207 ANDA ANDA203020 Unichem Pharmaceuticals (USA), Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 29300-213_44c0216e-d1c3-4fd6-a745-017009e12919 29300-213 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20151207 ANDA ANDA203020 Unichem Pharmaceuticals (USA), Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 29300-214_44c0216e-d1c3-4fd6-a745-017009e12919 29300-214 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20151207 ANDA ANDA203020 Unichem Pharmaceuticals (USA), Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 29300-215_a6e46ad6-9730-4646-bff2-f6d71bcd5ca7 29300-215 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170919 ANDA ANDA207018 Unichem Pharmaceuticals (USA), Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 29300-216_a6e46ad6-9730-4646-bff2-f6d71bcd5ca7 29300-216 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170919 ANDA ANDA207018 Unichem Pharmaceuticals (USA), Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 29300-220_9afb3667-ded0-474c-9844-fd7d3d1eb462 29300-220 HUMAN PRESCRIPTION DRUG montelukast sodium montelukast sodium TABLET, FILM COATED ORAL 20160101 ANDA ANDA204290 Unichem Pharmaceuticals (USA), Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 29300-226_dad5b878-0237-44ed-a7d2-b87a3c8fd60e 29300-226 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 Unichem Pharmaceuticals (USA), Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 29300-227_dad5b878-0237-44ed-a7d2-b87a3c8fd60e 29300-227 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 Unichem Pharmaceuticals (USA), Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 29300-241_75496a09-3e64-4469-8456-4506706d3e83 29300-241 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 Unichem Pharmaceuticals (USA), Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 29300-242_75496a09-3e64-4469-8456-4506706d3e83 29300-242 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 Unichem Pharmaceuticals (USA), Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 29300-243_75496a09-3e64-4469-8456-4506706d3e83 29300-243 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 Unichem Pharmaceuticals (USA), Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 29300-248_7af36a51-8b40-4142-8097-f2487f52ddff 29300-248 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20160623 ANDA ANDA203656 Unichem Pharmaceuticals (USA), Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 29300-249_7af36a51-8b40-4142-8097-f2487f52ddff 29300-249 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20160623 ANDA ANDA203656 Unichem Pharmaceuticals (USA), Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 29300-250_7af36a51-8b40-4142-8097-f2487f52ddff 29300-250 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20161110 ANDA ANDA204831 Unichem Pharmaceuticals (USA), Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 29300-251_7af36a51-8b40-4142-8097-f2487f52ddff 29300-251 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20161110 ANDA ANDA204831 Unichem Pharmaceuticals (USA), Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 29300-255_6a38e4c2-b1e8-4e7e-a4d5-f0d0d4fd6c28 29300-255 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20170801 ANDA ANDA208340 Unichem Pharmaceuticals (USA), Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 29300-256_6a38e4c2-b1e8-4e7e-a4d5-f0d0d4fd6c28 29300-256 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20170801 ANDA ANDA208340 Unichem Pharmaceuticals (USA), Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 29300-268_fe30244b-8c82-4f77-9514-0bdcb412616c 29300-268 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20170307 ANDA ANDA207835 Unichem Pharmaceuticals (USA), Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 29300-269_fe30244b-8c82-4f77-9514-0bdcb412616c 29300-269 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20170307 ANDA ANDA207835 Unichem Pharmaceuticals (USA), Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 29300-316_1601ef33-2f3e-47a9-bf13-76199f7aafc0 29300-316 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20170307 ANDA ANDA207836 Unichem Pharmaceuticals (USA), Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 29300-317_1601ef33-2f3e-47a9-bf13-76199f7aafc0 29300-317 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20170307 ANDA ANDA207836 Unichem Pharmaceuticals (USA), Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 29300-330_1be5f142-059a-45be-8553-058ffd7fa414 29300-330 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride TABLET ORAL 20101130 ANDA ANDA078680 Unichem Pharmaceuticals (USA), Inc. CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 29300-340_1be5f142-059a-45be-8553-058ffd7fa414 29300-340 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride TABLET ORAL 20101130 ANDA ANDA078680 Unichem Pharmaceuticals (USA), Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 29333-0001_18baeaac-60d9-43fb-986b-317a2fedfcc7 29333-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070201 UNAPPROVED MEDICAL GAS O24U OXYGEN 99 L/100L E 20171231 29336-301_d1e0020c-2fd3-920a-f196-2e1079eae8f4 29336-301 HUMAN PRESCRIPTION DRUG Minitran nitroglycerin PATCH TRANSDERMAL 20070401 ANDA ANDA089771 Graceway Pharmaceuticals, LLC NITROGLYCERIN 2.5 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 29336-302_d1e0020c-2fd3-920a-f196-2e1079eae8f4 29336-302 HUMAN PRESCRIPTION DRUG Minitran nitroglycerin PATCH TRANSDERMAL 20070401 ANDA ANDA089772 Graceway Pharmaceuticals, LLC NITROGLYCERIN 5 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 29336-303_d1e0020c-2fd3-920a-f196-2e1079eae8f4 29336-303 HUMAN PRESCRIPTION DRUG Minitran nitroglycerin PATCH TRANSDERMAL 20090810 ANDA ANDA089773 Graceway Pharmaceuticals, LLC NITROGLYCERIN 10 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 29336-304_d1e0020c-2fd3-920a-f196-2e1079eae8f4 29336-304 HUMAN PRESCRIPTION DRUG Minitran nitroglycerin PATCH TRANSDERMAL 20070401 ANDA ANDA089774 Graceway Pharmaceuticals, LLC NITROGLYCERIN 15 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 29336-321_590f4d2a-cb56-0b3e-4301-7bf5c148e3a0 29336-321 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20070401 ANDA ANDA089771 Graceway Pharmaceuticals, LLC NITROGLYCERIN 2.5 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 29336-322_590f4d2a-cb56-0b3e-4301-7bf5c148e3a0 29336-322 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20070401 ANDA ANDA089772 Graceway Pharmaceuticals, LLC NITROGLYCERIN 5 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 29336-323_590f4d2a-cb56-0b3e-4301-7bf5c148e3a0 29336-323 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20070404 ANDA ANDA089773 Graceway Pharmaceuticals, LLC NITROGLYCERIN 10 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 29336-324_590f4d2a-cb56-0b3e-4301-7bf5c148e3a0 29336-324 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20070401 ANDA ANDA089774 Graceway Pharmaceuticals, LLC NITROGLYCERIN 15 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 29485-1007_dd4c6524-182f-4755-be2f-242e9a32c432 29485-1007 HUMAN OTC DRUG Benadryl Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20080901 OTC MONOGRAPH FINAL part341 Mechanical Servants, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 29485-1073_0184b46f-48de-4566-a55d-7ee56b366e08 29485-1073 HUMAN OTC DRUG REFRESH TEARS carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20100101 OTC MONOGRAPH FINAL part349 Mechanical Servants, Inc. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL E 20171231 29485-1465_b5b8d054-f075-426e-b2e7-999ea7f89183 29485-1465 HUMAN OTC DRUG Motrin IB Ibuprofen TABLET, FILM COATED ORAL 20000801 NDA NDA019012 Mechanical Servants, LLC IBUPROFEN 200 mg/1 N 20191231 29485-1887_4fc61f5a-1b7e-4345-a252-bbaa3202eb6d 29485-1887 HUMAN OTC DRUG TYLENOL Acetaminophen Extra Strength Acetaminophen TABLET, COATED ORAL 19840819 OTC MONOGRAPH NOT FINAL part343 Mechanical Servants, LLC ACETAMINOPHEN 500 mg/1 E 20171231 29485-2827_a22863d6-9aef-4758-83cd-beafe91f3bb3 29485-2827 HUMAN OTC DRUG Vicks DayQuil Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100101 OTC MONOGRAPH FINAL part341 Mechanical Servants, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 29485-2828_a4a169f7-c4ae-401c-9dfc-170cbbf7c4a9 29485-2828 HUMAN OTC DRUG Vicks NyQuil Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20100101 OTC MONOGRAPH FINAL part341 Mechanical Servants, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 E 20171231 29485-3000_5b20e8c1-2f52-5fa6-e053-2a91aa0aec4e 29485-3000 HUMAN OTC DRUG Instant Hand Sanitizer HAND SANITIZER BEACH Alcohol LIQUID TOPICAL 20171002 OTC MONOGRAPH NOT FINAL part333A Mechanical Servants LLC ALCOHOL 70 g/100mL N 20181231 29485-6647_cd49e46c-a0ee-4131-a693-661e2d65b508 29485-6647 HUMAN OTC DRUG Mucinex DM DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN TABLET, EXTENDED RELEASE ORAL 20120626 NDA NDA021620 Mechanical Servants LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30; 600 mg/1; mg/1 N 20181231 29485-6741_92448d56-6df2-40f1-9d69-2f42999ae3c0 29485-6741 HUMAN OTC DRUG Dulcolax bisacodyl TABLET, COATED ORAL 20100101 OTC MONOGRAPH NOT FINAL part334 Mechanical Servants, Inc. BISACODYL 5 mg/1 E 20171231 29494-1104_33376694-fcce-6ed5-e054-00144ff8d46c 29494-1104 HUMAN PRESCRIPTION DRUG VividSensiGuard Sodium Flouride GEL, DENTIFRICE DENTAL; ORAL 20160613 UNAPPROVED DRUG OTHER Pearson Dental Supply Co. SODIUM FLUORIDE 11 mg/g E 20171231 29494-1105_33376694-fcce-6ed5-e054-00144ff8d46c 29494-1105 HUMAN PRESCRIPTION DRUG VividSensiGuard Sodium Fluoride GEL, DENTIFRICE DENTAL; ORAL 20160613 UNAPPROVED DRUG OTHER Pearson Dental Supply Co. SODIUM FLUORIDE 11 mg/g E 20171231 29500-0035_07dd9f08-1f2c-4c9f-81b7-644a479c4a83 29500-0035 HUMAN OTC DRUG Personal Care Antifungal TOLNAFTATE SPRAY TOPICAL 20100521 OTC MONOGRAPH FINAL part333C Personal Care Products, Inc. TOLNAFTATE 1 g/100g E 20171231 29500-0177_adc8053d-b1fb-410b-ba7c-f03d1dd5ea33 29500-0177 HUMAN OTC DRUG Oil Free Acne Wash SALICYLIC ACID LIQUID TOPICAL 20100523 OTC MONOGRAPH FINAL part358H Personal Care Products, Inc. SALICYLIC ACID 2 mL/100mL N 20181231 29500-0240_4f6da6b3-1de6-40d4-8ef5-414dc35d0ead 29500-0240 HUMAN OTC DRUG Sensitive Skin Deep Cleaning Astringent Salicylic Acid LIQUID TOPICAL 20100523 OTC MONOGRAPH FINAL part358H Personal Care Productrs SALICYLIC ACID .5 mL/100mL N 20181231 29500-0241_d2e8008f-af55-4820-ac5d-3ebfaee272bb 29500-0241 HUMAN OTC DRUG Oil Free Foaming Facial Cleanser TRICLOSAN LIQUID TOPICAL 20100524 OTC MONOGRAPH NOT FINAL part333 Personal Care Products, Inc. TRICLOSAN .25 mL/100mL N 20181231 29500-0555_08a84a41-00bd-41f5-ab29-cc38c1151fb4 29500-0555 HUMAN OTC DRUG 719 WALNUT AVE HAND fresh aloe BENZALKONIUM CHLORIDE LIQUID TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part333A Personal Care Products BENZALKONIUM CHLORIDE 78 mg/60mL N 20181231 29500-0819_aa6d87e0-cfa1-4cc0-af22-0036fca25bfd 29500-0819 HUMAN OTC DRUG ADVANCED FLUORIDE ANTICAVITY SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110124 OTC MONOGRAPH FINAL part355 Personal Care Products, LLC SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 29500-0864_ee564657-d6de-4e42-84c8-4492e5296389 29500-0864 HUMAN OTC DRUG Personal Care Creamy Petroleum Jelly PETROLATUM CREAM TOPICAL 20110107 OTC MONOGRAPH FINAL part347 PERSONAL CARE PRODUCTS, LLC PETROLATUM 30 g/100g N 20181231 29500-0881_18b9ce7f-e389-419b-b6db-feb9b5a15ec9 29500-0881 HUMAN OTC DRUG Personal Care Antibacterial Foaming Hand Wash TRICLOSAN LIQUID TOPICAL 20110107 OTC MONOGRAPH FINAL part333E Personal Care Products, LLC TRICLOSAN .4 mL/100mL N 20181231 29500-0908_b39f4bec-ac0b-42fc-be77-955ad03c796b 29500-0908 HUMAN OTC DRUG Wet Wipes BENZETHONIUM CHLORIDE CLOTH TOPICAL 20110803 OTC MONOGRAPH NOT FINAL part333A Personal Care Products BENZETHONIUM CHLORIDE .009 g/3g N 20181231 29500-1000_dfd252c8-306f-4bc2-ba7e-9116d27c8b77 29500-1000 HUMAN OTC DRUG Personal Care Alcohol, Benzethonium Chloride KIT 20091101 OTC MONOGRAPH NOT FINAL part333 Personal Care Products, Inc. N 20181231 29500-1497_52b5285e-6a48-4501-baae-fbb6075ad61b 29500-1497 HUMAN OTC DRUG Baby Love Diaper Rash ZINC OXIDE CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part347 Personal Care Products, Inc. ZINC OXIDE 16.51 g/127g E 20171231 29500-2113_d50e08a4-02d9-4f2e-a95d-7caf4e323bde 29500-2113 HUMAN OTC DRUG Personal Care Creamy Petroleum Jelly PETROLATUM CREAM TOPICAL 20110107 OTC MONOGRAPH FINAL part347 PERSONAL CARE PRODUCTS, LLC PETROLATUM 30 g/100g E 20171231 29500-2216_f95c434f-e25d-4cfa-bd7c-ca788e4b458a 29500-2216 HUMAN OTC DRUG Personal Care Pyrithione Zinc Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20110107 OTC MONOGRAPH FINAL part358H Personal Care Products, LLC PYRITHIONE ZINC 4.04 g/400mL N 20181231 29500-2224_47b37f46-1f79-48d9-a884-658056177af4 29500-2224 HUMAN OTC DRUG Creamy Cocoa Butter Petroleum Jelly PETROLATUM CREAM TOPICAL 20110119 OTC MONOGRAPH FINAL part347 Personal Care Products, LLC PETROLATUM 30 g/100g N 20181231 29500-2238_7bd2de97-4d53-4bc1-9e59-f7e94ae892d9 29500-2238 HUMAN OTC DRUG Advanced Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110124 OTC MONOGRAPH FINAL part355 Personal Care Products, LLC SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 29500-2264_23d313be-ba42-4b43-985f-9cade1dfa274 29500-2264 HUMAN OTC DRUG Vagi care Benzocaine, benzalkonium chloride CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Personal Care Products BENZOCAINE; BENZALKONIUM CHLORIDE 1.05; .003 g/21g; g/21g N 20181231 29500-2278_e20a0550-a963-4275-828e-bf41d30374eb 29500-2278 HUMAN OTC DRUG Personal Care Ice Cold Menthol GEL TOPICAL 20100604 OTC MONOGRAPH FINAL part348 Personal Care Products, Inc. MENTHOL 1 g/100g N 20181231 29500-2433_8d9b88cc-7bb7-4532-9a07-201713581ea0 29500-2433 HUMAN OTC DRUG Muscle Rub Ultra Strength Pain Relieving MENTHOL CREAM TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, Inc. MENTHOL 1.05 g/42g N 20181231 29500-2434_69c15fdd-eaf7-480c-a1b1-847830f9c47f 29500-2434 HUMAN OTC DRUG Jock Itch Antifungal CLOTRIMAZOLE CREAM TOPICAL 20130710 OTC MONOGRAPH FINAL part333C Personal Care Products, Inc. CLOTRIMAZOLE 420 mg/42g N 20181231 29500-2435_485c5449-83f7-4988-bac9-ea4fd3745fed 29500-2435 HUMAN OTC DRUG Athletes Foot Antifungal Antifungal CLOTRIMAZOLE CREAM TOPICAL 20130710 OTC MONOGRAPH FINAL part333C Personal Care Products, Inc. CLOTRIMAZOLE 350 mg/35g N 20181231 29500-2436_629d8eeb-d02d-4c7d-87e6-40542a82d989 29500-2436 HUMAN OTC DRUG Triple Antibiotic Extra Strength BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE OINTMENT TOPICAL 20130710 OTC MONOGRAPH FINAL part333B Personal Care Products, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/9.4g; mg/9.4g; [iU]/9.4g N 20181231 29500-2437_69bf5fe2-9930-4fbb-a2d0-6a61f46dbfbf 29500-2437 HUMAN OTC DRUG Anti-Itch Extra Strength DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 700; 35 mg/35g; mg/35g N 20181231 29500-2438_2c095063-30f4-4aba-8ffd-ccd2deab02a8 29500-2438 HUMAN OTC DRUG Anesthetic Hemorrhoidal With Aloe PRAMOXINE HYDROCHLORIDE, ZINC OXIDE OINTMENT TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part347 Personal Care Products, Inc. PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 420; 5.25 mg/42g; g/42g N 20181231 29500-2439_328f2e5f-41e1-474e-8f3a-e44281048e61 29500-2439 HUMAN OTC DRUG Hydrocortisone Ultra Strength HYDROCORTISONE CREAM TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, Inc. HYDROCORTISONE 140 mg/14g N 20181231 29500-2493_654946fc-51d0-47dc-a918-474e7ddfecf8 29500-2493 HUMAN OTC DRUG MUSCLE RUB MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, LLC MENTHOL; METHYL SALICYLATE 3.5; 5.25 g/35g; g/35g E 20171231 29500-6000_55ae3c2c-3a3e-4435-be11-88afb9bc0783 29500-6000 HUMAN OTC DRUG Personal Care Pyrithione Zinc Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20100122 OTC MONOGRAPH FINAL part358H Personal Care Products, Inc. PYRITHIONE ZINC 1 g/100mL N 20181231 29500-7000_ba6c88c0-fbcf-4e3a-8ec4-49b67b63eb48 29500-7000 HUMAN OTC DRUG Personal Care Sensitive Skin Deep Cleaning Astringent SALICYLIC ACID LIQUID TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part333D Personal Care Products, LLC SALICYLIC ACID .5 mL/100mL E 20171231 29500-7010_8ef2c353-ec28-4551-ae58-e724056e8518 29500-7010 HUMAN OTC DRUG Personal Care Oil Free Foaming Facial Cleanser TRICLOSAN LIQUID TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part333A Personal Care Products, Inc TRICLOSAN .25 mL/100mL N 20181231 29500-7020_987eb72d-5dc7-462a-aa42-f9a0da6a9b03 29500-7020 HUMAN OTC DRUG Personal Care Oil-Free Acne Wash SALICYLIC ACID LIQUID TOPICAL 20100120 OTC MONOGRAPH FINAL part358H Personal Care Products, Inc SALICYLIC ACID 2 mL/100mL N 20181231 29500-7820_8ab3ce88-2742-4126-8600-5aed16d490d5 29500-7820 HUMAN OTC DRUG Vagicaine BENZOCAINE, RESORCINOL CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, Inc. BENZOCAINE; RESORCINOL 5.67; .85 g/28g; g/28g E 20171231 29500-8010_8af960fe-20ef-4f21-ac98-1d768e2b2665 29500-8010 HUMAN OTC DRUG Personal Care Petroleum petrolatum JELLY TOPICAL 20120701 OTC MONOGRAPH FINAL part346 PERSONAL CARE PRODUCTS PETROLATUM 170 g/170g N 20181231 29500-8020_31720587-a37f-4a21-b4a0-d8e98a3a0d9d 29500-8020 HUMAN OTC DRUG Personal Care Petroleum petrolatum JELLY TOPICAL 20120701 OTC MONOGRAPH FINAL part346 Personal Care Products PETROLATUM 100 g/100g N 20181231 29500-8030_90036340-e1e3-428f-8a09-632cf3b31a7a 29500-8030 HUMAN OTC DRUG Personal Care Petroleum petrolatum JELLY TOPICAL 20120701 OTC MONOGRAPH FINAL part346 Personal Care Products PETROLATUM 170 g/170g N 20181231 29500-8040_4746fdd0-b393-491c-aaa1-9517c2ecf53c 29500-8040 HUMAN OTC DRUG Petroleum Petrolatum JELLY TOPICAL 20120701 OTC MONOGRAPH FINAL part346 Personal Care Products PETROLATUM 99.9 g/100g N 20181231 29500-8050_2292397c-27b5-4a21-9b18-1412a9978a81 29500-8050 HUMAN OTC DRUG Personal Care Products petroleum petrolatum JELLY TOPICAL 20120629 OTC MONOGRAPH FINAL part346 Personal Care Products PETROLATUM 1 g/g N 20181231 29500-8050_5c4923fd-29b1-4fff-b52c-28249dd39fa1 29500-8050 HUMAN OTC DRUG Personal Care Petroleum petrolatum JELLY TOPICAL 20120701 OTC MONOGRAPH FINAL part346 PERSONAL CARE PRODUCTS PETROLATUM 100 g/100g N 20181231 29500-8060_f683473c-a4f5-411c-9855-2a9cb90127cb 29500-8060 HUMAN OTC DRUG Personal Care Petroleum Jelly Skin Protectant White Petroleum GEL TOPICAL 20100325 OTC MONOGRAPH FINAL part347 Personal Care Products, Inc PETROLATUM 100 g/g N 20181231 29500-9018_f3520653-19b9-4771-adc1-4043e8a0a671 29500-9018 HUMAN OTC DRUG Personal CARE Antibacterial Foaming Hand Fresh Picked Strawberries BENZALKONIUM CHLORIDE LIQUID TOPICAL 20151210 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC BENZALKONIUM CHLORIDE .0002218 mg/221.8mL N 20181231 29500-9020_f3520653-19b9-4771-adc1-4043e8a0a671 29500-9020 HUMAN OTC DRUG Personal CARE Antibacterial Foaming Hand Beach Breeze BENZALKONIUM CHLORIDE LIQUID TOPICAL 20151210 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC BENZALKONIUM CHLORIDE .0002218 mg/221.8mL N 20181231 29500-903_9fc68949-3cb7-4c68-893d-3408a9501a31 29500-903 HUMAN OTC DRUG Antibacterial triclosan SOAP TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC TRICLOSAN .888 mL/444mL E 20171231 29500-9033_163dd1a2-964c-4184-82e2-7f965d81714b 29500-9033 HUMAN OTC DRUG Vaporizing Chest camphor, menthol, eucalyptus SALVE TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part348 Personal Care Products CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 5.31; 1.13; 1.13 g/113g; g/113g; g/113g N 20181231 29500-9034_ce7d5be7-57b3-41d3-a591-5483cab4fbf9 29500-9034 HUMAN OTC DRUG Ice Cold Analgesic Menthol GEL TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part348 Personal Care Products MENTHOL 2.27 g/227g N 20181231 29500-9038_eec8fc4f-bd64-4832-8db4-4ed6b7d1b231 29500-9038 HUMAN OTC DRUG Personal Care Antibacterial Hand TRICLOSAN SOAP TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC TRICLOSAN .2 mL/100mL N 20181231 29500-907_84ac8936-94ff-4305-ad67-db6efa592bdc 29500-907 HUMAN OTC DRUG hand triclosan SOAP TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333A Personal Care Products TRICLOSAN .888 mL/444mL N 20181231 29500-907_8f44f0a7-16a2-42ae-83ad-5f6ca7ae7f1a 29500-907 HUMAN OTC DRUG hand triclosan SOAP TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333A Personal Care Products TRICLOSAN .888 mL/444mL N 20181231 29500-9077_4fea0c74-56e5-4c6c-9537-950c02b40db2 29500-9077 HUMAN OTC DRUG Personal Care Antibacterial Hand - Raspberry TRICLOSAN SOAP TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC TRICLOSAN .2 mL/100mL N 20181231 29500-9077_baceb0f2-d7f2-4bc6-9a89-bb91099e1bc1 29500-9077 HUMAN OTC DRUG antibacterial hand triclosan SOAP TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333A Personal Care Products TRICLOSAN .886 mL/443mL N 20181231 29500-9078_e2865416-b02d-41bc-9daf-b545d1263d9b 29500-9078 HUMAN OTC DRUG Personal Care Antibacterial Hand - Fresh Peach TRICLOSAN SOAP TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC TRICLOSAN .2 mL/100mL N 20181231 29500-9079_46b8352a-6179-4f57-bb48-a37aca3a223f 29500-9079 HUMAN OTC DRUG Personal Care Antibacterial Hand - Fresh Melon TRICLOSAN SOAP TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC TRICLOSAN .2 mL/100mL N 20181231 29500-9080_d99c4926-aa77-4e34-946b-b0de77300541 29500-9080 HUMAN OTC DRUG Personal Care alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333A Personal Care Products, Inc. ALCOHOL .62 mL/mL N 20181231 29500-9082_626d1b00-e213-4cc8-8947-857bb04b7649 29500-9082 HUMAN OTC DRUG Acne Control oil-free Cleansing SALICYLIC ACID LIQUID TOPICAL 20151001 OTC MONOGRAPH FINAL part333D Personal Care Products, LLC SALICYLIC ACID 29.2 mg/1 E 20171231 29500-9083_a5d0297b-7c72-40df-a650-2eca0117dab2 29500-9083 HUMAN OTC DRUG PERSONAL CARE EXTRA STRENGTH COLD HOT MENTHOL PATCH TOPICAL 20110920 OTC MONOGRAPH NOT FINAL part348 PERSONAL CARE PRODUCTS, LLC MENTHOL 50 mg/1 N 20181231 29500-9085_44fb2879-50e7-4501-a3ba-3aa055ef21f9 29500-9085 HUMAN OTC DRUG Hand Sanitizer ethyl alcohol GEL TOPICAL 20120120 OTC MONOGRAPH NOT FINAL part333A Personal Care Products ALCOHOL 9.3 mL/60mL N 20181231 29500-9085_48eca6ed-5470-4e21-ab6e-3ecf598229bb 29500-9085 HUMAN OTC DRUG Personal Care Hand Sanitizer ALCOHOL GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333A Personal Care Products, Inc. ALCOHOL .62 mL/mL N 20181231 29500-9086_5dfc161b-2aab-41cd-8295-0ed3568e2dde 29500-9086 HUMAN OTC DRUG Instant Hand Sanitizer and Moisterizer Ethyl alcohol LIQUID TOPICAL 20111114 OTC MONOGRAPH NOT FINAL part333A Personal Care Products ALCOHOL 146 mL/236mL N 20181231 29500-9087_b635599f-bbdc-4b33-ae77-9d4b761669b8 29500-9087 HUMAN OTC DRUG Powerhouse Fresh Scent Ultra Dish Triclosan SOAP TOPICAL 20111219 OTC MONOGRAPH NOT FINAL part333A Personal Care Products TRICLOSAN .562 mL/562mL N 20181231 29500-9088_f4d8069c-dfdc-4f2a-b0fc-76f61eef85b0 29500-9088 HUMAN OTC DRUG Hand Sanitizer benzalkonium chloride AEROSOL, FOAM TOPICAL 20110705 OTC MONOGRAPH NOT FINAL part333A Personal Care Products BENZALKONIUM CHLORIDE .27 mL/207mL N 20181231 29500-909_1ee5fe86-8677-4380-bfcb-7fa1c55a7202 29500-909 HUMAN OTC DRUG Hand Sanitizer alcohol GEL TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A Personal Care Products ALCOHOL 146.3 mL/236mL E 20171231 29500-9090_deed0020-4c72-499b-90f4-8b8b3bd68ef8 29500-9090 HUMAN OTC DRUG Personal Care Medicated Body Powder POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, Inc. MENTHOL; ZINC OXIDE 3; 20 mg/2g; mg/2g N 20181231 29500-9091_81b6c114-1bac-49de-a7db-cf436fec662a 29500-9091 HUMAN OTC DRUG Personal Care Medicated Foot Powder POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part348 Personal Care Products, Inc. MENTHOL 20 mg/2g N 20181231 29500-910_984705b1-d7e6-4f4f-b090-e4c4e8d6b521 29500-910 HUMAN OTC DRUG Hand Sanitizer alcohol GEL TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A Personal Care Products ALCOHOL 184.6 mL/355mL N 20181231 29500-9132_446558fd-517c-42c2-addd-ec0193d45220 29500-9132 HUMAN OTC DRUG Red Hot Cinnamon ALCOHOL LIQUID TOPICAL 20161123 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9133_446558fd-517c-42c2-addd-ec0193d45220 29500-9133 HUMAN OTC DRUG Cheeky Fresh ALCOHOL LIQUID TOPICAL 20161123 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9134_446558fd-517c-42c2-addd-ec0193d45220 29500-9134 HUMAN OTC DRUG Love You Berry Much ALCOHOL LIQUID TOPICAL 20161123 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9135_446558fd-517c-42c2-addd-ec0193d45220 29500-9135 HUMAN OTC DRUG Sunny Tropicolada ALCOHOL LIQUID TOPICAL 20161123 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9137_446558fd-517c-42c2-addd-ec0193d45220 29500-9137 HUMAN OTC DRUG Fresh Breeze ALCOHOL LIQUID TOPICAL 20161123 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9138_446558fd-517c-42c2-addd-ec0193d45220 29500-9138 HUMAN OTC DRUG Crazy Coconut ALCOHOL LIQUID TOPICAL 20161123 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9139_446558fd-517c-42c2-addd-ec0193d45220 29500-9139 HUMAN OTC DRUG Purrfect Cherry ALCOHOL LIQUID TOPICAL 20161123 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9140_446558fd-517c-42c2-addd-ec0193d45220 29500-9140 HUMAN OTC DRUG Citrus Sparkle ALCOHOL LIQUID TOPICAL 20161123 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9181_3113d887-5ed1-4aa3-8725-913db8c3dfba 29500-9181 HUMAN OTC DRUG ADVANCED FLUORIDE ANTICAVITY SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20170724 OTC MONOGRAPH FINAL part355 Personal Care Products, LLC SODIUM MONOFLUOROPHOSPHATE 1000 mg/181g N 20181231 29500-9208_ec7f2d22-ffc3-4609-b8dc-20934afe30c5 29500-9208 HUMAN OTC DRUG Personal Care Antibacterial Triclocarben SOAP TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC TRICLOCARBAN .67 g/86g N 20181231 29500-9210_107b0b4d-ea99-464d-aea7-40dfbfaa9e0e 29500-9210 HUMAN OTC DRUG Solid anti perspirant aluminum chlorohydrate CREAM TOPICAL 20110727 OTC MONOGRAPH FINAL part350 Personal Care Products ALUMINUM CHLOROHYDRATE 11.4 g/57g N 20181231 29500-9211_74bb0f48-d370-43d0-ad93-ad63ebac61fe 29500-9211 HUMAN OTC DRUG Ultra dry antiperspirant aluminum chlorhydrate CREAM TOPICAL 20110727 OTC MONOGRAPH FINAL part350 Personal Care Products ALUMINUM CHLOROHYDRATE 11.4 g/57g N 20181231 29500-9223_899b6434-3f80-4f56-bf3d-147230a6d0b3 29500-9223 HUMAN OTC DRUG Advanced Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20170724 OTC MONOGRAPH FINAL part355 Personal Care Products, LLC SODIUM MONOFLUOROPHOSPHATE 1000 mg/181g N 20181231 29500-9233_5fd3182a-fac4-4ba7-9c3d-088fcb874b45 29500-9233 HUMAN OTC DRUG Vaporizing Chest camphor, menthol SALVE TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part348 Personal Care Products CAMPHOR (SYNTHETIC); MENTHOL 5.31; 1.13 g/113g; g/113g N 20181231 29500-9280_030c6510-ba89-436b-af32-203199179002 29500-9280 HUMAN OTC DRUG Personal Care Hand Sanitizer Aloe ALCOHOL GEL TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part333 Personal Care Products, Inc. ALCOHOL 62 mL/100mL N 20181231 29500-9301_aae7fe50-4070-48f7-bf98-c7bb5d35043e 29500-9301 HUMAN OTC DRUG Personal Care Antibacterial Hand Coconut Ginger CHLOROXYLENOL LIQUID TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part333A Personal Care Products, LLC CHLOROXYLENOL .6657 mg/221.8mL N 20181231 29500-9309_71032671-4ebe-4cff-9aeb-b39e96342550 29500-9309 HUMAN OTC DRUG Personal CARE Acne Control SALICYLIC ACID LIQUID TOPICAL 20151112 OTC MONOGRAPH FINAL part333D Personal Care Products SALICYLIC ACID .025 g/1 N 20181231 29500-9311_bf049cb6-699c-4487-be72-1d03d2d0c5a0 29500-9311 HUMAN OTC DRUG Penguin Icicles ALCOHOL LIQUID TOPICAL 20160921 OTC MONOGRAPH NOT FINAL part333E Personal Care Products LLC ALCOHOL 17.57 g/30mL N 20181231 29500-9317_bf049cb6-699c-4487-be72-1d03d2d0c5a0 29500-9317 HUMAN OTC DRUG Hootin Pomegranate ALCOHOL LIQUID TOPICAL 20160921 OTC MONOGRAPH NOT FINAL part333E Personal Care Products LLC ALCOHOL 17.57 g/30mL N 20181231 29500-9318_bf049cb6-699c-4487-be72-1d03d2d0c5a0 29500-9318 HUMAN OTC DRUG Gingerbread Jubilee ALCOHOL LIQUID TOPICAL 20160921 OTC MONOGRAPH NOT FINAL part333E Personal Care Products LLC ALCOHOL 17.57 g/30mL N 20181231 29500-9319_f3520653-19b9-4771-adc1-4043e8a0a671 29500-9319 HUMAN OTC DRUG Personal CARE Antibacterial Foaming Hand Citrus Sunshine BENZALKONIUM CHLORIDE LIQUID TOPICAL 20151210 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC BENZALKONIUM CHLORIDE .0002218 mg/221.8mL N 20181231 29500-9354_fb573247-bedd-4dbb-bb32-9f1e7cee5127 29500-9354 HUMAN OTC DRUG Laughing Linen ALCOHOL LIQUID TOPICAL 20170323 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9355_fb573247-bedd-4dbb-bb32-9f1e7cee5127 29500-9355 HUMAN OTC DRUG Citrus Sunshine ALCOHOL LIQUID TOPICAL 20170323 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9356_fb573247-bedd-4dbb-bb32-9f1e7cee5127 29500-9356 HUMAN OTC DRUG Love You Berry Much ALCOHOL LIQUID TOPICAL 20170323 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9357_fb573247-bedd-4dbb-bb32-9f1e7cee5127 29500-9357 HUMAN OTC DRUG Coconut Lime ALCOHOL LIQUID TOPICAL 20170323 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9359_fb573247-bedd-4dbb-bb32-9f1e7cee5127 29500-9359 HUMAN OTC DRUG Frisky Cinnamon ALCOHOL LIQUID TOPICAL 20170323 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9360_fb573247-bedd-4dbb-bb32-9f1e7cee5127 29500-9360 HUMAN OTC DRUG Foxy Citrus ALCOHOL LIQUID TOPICAL 20170323 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9361_fb573247-bedd-4dbb-bb32-9f1e7cee5127 29500-9361 HUMAN OTC DRUG Fresh Breeze ALCOHOL LIQUID TOPICAL 20170323 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9362_fb573247-bedd-4dbb-bb32-9f1e7cee5127 29500-9362 HUMAN OTC DRUG Pretty Punch ALCOHOL LIQUID TOPICAL 20170323 OTC MONOGRAPH NOT FINAL part333A Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9393_c0562994-97d2-4a40-b560-ebaf82c1e51a 29500-9393 HUMAN OTC DRUG Candy Cane ETHYL ALCOHOL LIQUID TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part333E Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9394_c0562994-97d2-4a40-b560-ebaf82c1e51a 29500-9394 HUMAN OTC DRUG Crisp Evergreen ETHYL ALCOHOL LIQUID TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part333E Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9395_c0562994-97d2-4a40-b560-ebaf82c1e51a 29500-9395 HUMAN OTC DRUG Sparkling Snow ETHYL ALCOHOL LIQUID TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part333E Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9396_c0562994-97d2-4a40-b560-ebaf82c1e51a 29500-9396 HUMAN OTC DRUG Lovely Lavender ETHYL ALCOHOL LIQUID TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part333E Personal Care Products LLC ALCOHOL 26.36 g/44mL N 20181231 29500-9399_bf049cb6-699c-4487-be72-1d03d2d0c5a0 29500-9399 HUMAN OTC DRUG Evergreen Snowman ALCOHOL LIQUID TOPICAL 20160921 OTC MONOGRAPH NOT FINAL part333E Personal Care Products LLC ALCOHOL 17.57 g/30mL N 20181231 29500-9409_7d80702c-1175-4be8-890c-8c63ea783ecb 29500-9409 HUMAN OTC DRUG Hootin Pomegranate HAND SANITIZER ALCOHOL LIQUID TOPICAL 20160512 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC ALCOHOL 17.57 g/30mL N 20181231 29500-9410_7d80702c-1175-4be8-890c-8c63ea783ecb 29500-9410 HUMAN OTC DRUG Funky Monkey Hawaiian HAND SANITIZER ALCOHOL LIQUID TOPICAL 20160512 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC ALCOHOL 17.57 g/30mL N 20181231 29500-9411_7d80702c-1175-4be8-890c-8c63ea783ecb 29500-9411 HUMAN OTC DRUG Purrfect Rasberry HAND SANITIZER ALCOHOL LIQUID TOPICAL 20160512 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC ALCOHOL 17.57 g/30mL N 20181231 29500-9412_7d80702c-1175-4be8-890c-8c63ea783ecb 29500-9412 HUMAN OTC DRUG Leap Frog Fresh HAND SANITIZER ALCOHOL LIQUID TOPICAL 20160512 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC ALCOHOL 17.57 g/30mL N 20181231 29500-9710_ef72c22a-4027-44d7-887f-69ebe37ca00f 29500-9710 HUMAN OTC DRUG Touch Free Hand benzethonium chloride SOAP TOPICAL 20110728 OTC MONOGRAPH NOT FINAL part333A Personal Care Products BENZETHONIUM CHLORIDE .33 mL/251mL N 20181231 29500-9711_72e329f5-20f9-4cfc-99e2-a24b393a34ee 29500-9711 HUMAN OTC DRUG Touch Free Hand benzethonium chloride SOAP TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part333A Personal Care Products BENZETHONIUM CHLORIDE .33 mL/251mL N 20181231 29500-9804_29dc36aa-125d-45ae-aadb-ea3108ca8da8 29500-9804 HUMAN OTC DRUG Personal Care Therapeutic T Plus Gel COAL TAR SHAMPOO TOPICAL 20100303 OTC MONOGRAPH FINAL part358H Personal Care Products COAL TAR .5 g/100mL N 20181231 29500-9881_f3520653-19b9-4771-adc1-4043e8a0a671 29500-9881 HUMAN OTC DRUG Personal CARE Antibacterial Foaming Hand Wild Flowers BENZALKONIUM CHLORIDE LIQUID TOPICAL 20151210 OTC MONOGRAPH NOT FINAL part333E Personal Care Products, LLC BENZALKONIUM CHLORIDE .0002218 mg/221.8mL N 20181231 29558-001_46c996c7-1eae-45dc-90b3-9cfc39f2fe49 29558-001 HUMAN OTC DRUG Edge GAMBIR, MUCUNA PRURIENS SEED, ERYTHROXYLUM CATUABA BARK, EPIMEDIUM GRANDIFLORUM TOP, TURNERA DIFFUSA LEAF, GINKGO, ELEUTHERO, PANAX NOTOGINSENG ROOT,TRIBULUS TERRESTRIS FRUIT GEL TOPICAL 20150401 UNAPPROVED DRUG OTHER Aloe Vera Industries Pty Ltd GAMBIR; MUCUNA PRURIENS SEED; ERYTHROXYLUM CATUABA BARK; EPIMEDIUM GRANDIFLORUM TOP; TURNERA DIFFUSA LEAF; GINKGO; ELEUTHERO; PANAX NOTOGINSENG ROOT; TRIBULUS TERRESTRIS FRUIT 2; .025; .025; .012; .124; .124; .124; .018; .124 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 29565-200_3fa25193-21b8-440e-84e8-c8b7a175186d 29565-200 HUMAN OTC DRUG Sunscreen SPF30 Plus Broad Spectrum Zinc oxide LOTION TOPICAL 20060101 OTC MONOGRAPH FINAL part352 UV Natural International Pty Ltd ZINC OXIDE 12.9 mL/52mL E 20171231 29565-300_a25e7ffa-6864-41be-bf98-7523104d1a73 29565-300 HUMAN OTC DRUG Sunscreen Baby SPF30 Plus Broad Spectrum Zinc oxide LOTION TOPICAL 20060101 OTC MONOGRAPH FINAL part352 UV Natural International Pty Ltd ZINC OXIDE 12.9 mL/52mL E 20171231 29565-400_0cb2033f-d54f-4b90-9c62-6f64c12eb163 29565-400 HUMAN OTC DRUG Sunscreen Sport SPF30 Plus Broad Spectrum Zinc oxide LOTION TOPICAL 20060101 OTC MONOGRAPH FINAL part352 UV Natural International Pty Ltd ZINC OXIDE 32.3 mL/130mL E 20171231 29565-500_1984c790-e826-41a0-a8c3-1b666b84a2db 29565-500 HUMAN OTC DRUG Sunscreen Sport Lip SPF30 Plus Broad Spectrum Zinc oxide LOTION TOPICAL 20060101 OTC MONOGRAPH FINAL part352 UV Natural International Pty Ltd ZINC OXIDE 1.24 mL/5mL E 20171231 29784-171_4881c9b1-b9d0-1b48-e054-00144ff88e88 29784-171 HUMAN OTC DRUG ProCure Hydrocortisone Plus Calendula Hydrocortisone CREAM TOPICAL 20170214 OTC MONOGRAPH NOT FINAL part348 Profoot, Inc. HYDROCORTISONE 10 mg/g N 20181231 29784-181_4881001c-c1dd-2033-e054-00144ff8d46c 29784-181 HUMAN OTC DRUG ProClearz Maximum Strength Fungal Shield Brush-on Antifungal Tolnaftate SOLUTION TOPICAL 20121022 OTC MONOGRAPH FINAL part333C Profoot, Inc. TOLNAFTATE 10 mg/mL N 20181231 29784-189_61304306-d9fd-5c75-e053-2a91aa0a7c6b 29784-189 HUMAN OTC DRUG ProClearz Maximum Strength Anti-fungal Pen Tolnaftate LIQUID TOPICAL 20121023 OTC MONOGRAPH FINAL part333C Profoot, Inc. TOLNAFTATE 10 mg/mL N 20181231 29784-191_b361bf0a-9594-4dbf-9c71-c73c53cd5c3f 29784-191 HUMAN OTC DRUG ProClearz Fungi-Cide PM Tolnaftate CREAM TOPICAL 20121010 OTC MONOGRAPH FINAL part333C Profoot, Inc. TOLNAFTATE 1 g/100g N 20181231 29860-002_b5cd8504-28fa-4a1a-8074-78fc20307fa6 29860-002 HUMAN OTC DRUG ANTIBACTERIAL AMBER HAND SOAP TRICLOSAN LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Ningbo United Group Import and Export Co. Ltd. TRICLOSAN .04 mL/100mL E 20171231 29860-200_3f47429d-213c-4e6f-8c48-e42763589c32 29860-200 HUMAN OTC DRUG Virx Instant Hand Sanitizer GEL TOPICAL 20091101 OTC MONOGRAPH FINAL part333 Ningbo United Group Co., Ltd. ALCOHOL 215.14 mL/347mL E 20171231 29860-203_57c78e9b-2171-4627-80b1-e9644c022d83 29860-203 HUMAN OTC DRUG Virx Instant Hand Sanitizer with Security Clip GEL TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Ningbo United Group Co. Ltd. ALCOHOL 74.4 mL/120mL E 20171231 29860-205_733bb21f-ae49-4d01-ac0c-e8463d4b2106 29860-205 HUMAN OTC DRUG Virx Instant Hand Sanitizer GEL TOPICAL 20100201 OTC MONOGRAPH FINAL part333 Ningbo United Group Co., Ltd. ALCOHOL 146.32 mL/236mL E 20171231 29860-209_47284e3e-946d-4c99-a505-dd712725da8c 29860-209 HUMAN OTC DRUG Pacific Antibaceterial Hand Soap Rose SOAP TOPICAL 20100304 OTC MONOGRAPH FINAL part333 Ningbo United TRICLOSAN 318.975 mL/2126.5mL E 20171231 29860-213_d2f3a483-13db-4ccf-a8ac-b47b22b9468c 29860-213 HUMAN OTC DRUG Pacific Antibaceterial Hand Soap Rose SOAP TOPICAL 20100304 OTC MONOGRAPH FINAL part333 Ningbo United TRICLOSAN 318.975 mL/2126.5mL E 20171231 29860-217_ed7ea68f-f5fc-4dec-b78f-5f9bab6c5999 29860-217 HUMAN OTC DRUG Pacific Antibaceterial Hand Soap Lavender SOAP TOPICAL 20100302 OTC MONOGRAPH FINAL part333 Ningbo United TRICLOSAN 318.975 mL/2126.5mL E 20171231 29860-221_05e1b5da-19a2-4f5e-bb1e-6665838e0cfd 29860-221 HUMAN OTC DRUG Pacific Antibaceterial Hand Soap Golden Sunflower SOAP TOPICAL 20100304 OTC MONOGRAPH FINAL part333 Ningbo United TRICLOSAN 318.975 mL/2126.5mL E 20171231 29943-002_b5b15f49-b91a-43c6-b862-4655bc9eaa7f 29943-002 HUMAN OTC DRUG blink tears polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20080201 OTC MONOGRAPH FINAL part349 AMO Hangzhou Co., LTD POLYETHYLENE GLYCOL 400 2.5 mg/mL N 20181231 29943-004_1485b66e-f520-42cc-8aad-0f033ce933d1 29943-004 HUMAN OTC DRUG blink gel tears polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20080501 OTC MONOGRAPH FINAL part349 AMO Hangzhou Co., LTD POLYETHYLENE GLYCOL 400 2.5 mg/mL N 20181231 29978-127_63900fab-b3fe-45fc-84a9-8ca1cd4ea798 29978-127 HUMAN OTC DRUG Capron DM Dextromethorphan HBr and Pyrilamine Maleate LIQUID ORAL 20130620 OTC MONOGRAPH FINAL part341 Capital Pharmaceutical, LLC DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE 7.5; 7.5 mg/5mL; mg/5mL N 20181231 29978-128_50222df4-5c32-1304-e054-00144ff88e88 29978-128 HUMAN OTC DRUG Capron DMT Dextromethorphan HBr and Pyrilamine Maleate TABLET ORAL 20170126 OTC MONOGRAPH FINAL part341 Capital Pharma DEXTROMETHORPHAN HYDROBROMIDE; PYRILAMINE MALEATE 30; 30 mg/1; mg/1 N 20181231 29978-420_61473186-c2f3-780e-e053-2a91aa0a57aa 29978-420 HUMAN OTC DRUG CapCof Codeine Phosphate, Phenylephrine Hydrochloride, Chlorpheniramine Maleate LIQUID ORAL 20101008 OTC MONOGRAPH FINAL part341 Capital Pharmaceutical, LLC CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE 10; 5; 2 mg/5mL; mg/5mL; mg/5mL CV N 20181231 29978-587_5062e6a5-a817-4ef8-9bec-b37b85a385cc 29978-587 HUMAN OTC DRUG Aquanaz Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine Hydrochloride TABLET ORAL 20150310 OTC MONOGRAPH FINAL part341 Capital Pharmaceutical, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 400; 10 mg/1; mg/1; mg/1 E 20171231 29978-601_f1610d30-0f88-41fd-b2ba-901d280af34a 29978-601 HUMAN OTC DRUG Capmist DM Dextromethorphan Hydrobromide, Guaifenesin and Pseudoephedrine Hydrochloride TABLET ORAL 20130620 OTC MONOGRAPH FINAL part341 Capital Pharmaceutical, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 400; 60 mg/1; mg/1; mg/1 N 20181231 29978-606_7b3ee236-d486-4723-833f-205a281f8fb7 29978-606 HUMAN OTC DRUG CAPMIST DM Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride TABLET ORAL 20110727 OTC MONOGRAPH FINAL part341 Capital Pharmaceutical DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 30; 400; 30 mg/1; mg/1; mg/1 E 20171231 29978-918_2422f771-1d31-4a53-b5fe-7c3eeb31e5d4 29978-918 HUMAN OTC DRUG Alevazol Clotrimazole OINTMENT TOPICAL 20140901 OTC MONOGRAPH FINAL part333C Capital Pharmaceutical, LLC CLOTRIMAZOLE 10 mg/g E 20171231 29991-505_999446b3-64c8-48a8-8505-48ec151f795d 29991-505 HUMAN OTC DRUG KSS CLEAN HANDS ANTISEPTIC CLEANER Chloroxylenol LIQUID TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333 KSS Enterprises CHLOROXYLENOL 10.22 g/1000mL E 20171231 30014-102_dde28243-e8e2-4326-9663-70964271974b 30014-102 HUMAN OTC DRUG Tucks Medicated Cooling Pads Witch Hazel CLOTH TOPICAL 20070701 20180501 OTC MONOGRAPH FINAL part346 Johnson & Johnson Consumer Inc. WITCH HAZEL 500 mg/1 N 20181231 30056-002_1e5df8c8-14d6-4e52-8ccc-4294da7e1962 30056-002 HUMAN OTC DRUG Sani-Kleen Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part333A Eco-Logics, Inc. ALCOHOL 620 mL/L E 20171231 30056-004_5c62008e-b82c-6089-e053-2a91aa0a71e1 30056-004 HUMAN OTC DRUG Elgin Pain Relief Menthol GEL TOPICAL 20160711 OTC MONOGRAPH NOT FINAL part348 Eco-Logics, Inc. MENTHOL 35 mg/g N 20181231 30056-004_5c6222ae-ddc8-848a-e053-2991aa0abc5c 30056-004 HUMAN OTC DRUG Elgin Pain Relief Menthol GEL TOPICAL 20160711 OTC MONOGRAPH NOT FINAL part348 Eco-Logics, Inc. MENTHOL 35 mg/g N 20181231 30056-004_5c6222ae-ddca-848a-e053-2991aa0abc5c 30056-004 HUMAN OTC DRUG Elgin Pain Relief Menthol GEL TOPICAL 20160711 OTC MONOGRAPH NOT FINAL part348 Eco-Logics, Inc. MENTHOL 35 mg/g N 20181231 30056-005_10e7a76a-f3cc-4da7-bf7a-49f808c3f564 30056-005 HUMAN OTC DRUG Elgin Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part347 Eco-Logics, Inc. ALCOHOL 620 mg/g E 20171231 30056-006_0c7b08ae-7b24-4f32-bb80-e5205c28097b 30056-006 HUMAN OTC DRUG Advanced Healing Diabetic Skin Care Dimethicone LOTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part347 Eco-Logics, Inc. DIMETHICONE 10 mg/g E 20171231 30056-007_1fdfaf71-3d1d-4512-8070-25a49b229d05 30056-007 HUMAN OTC DRUG Therapeutic Herbal Muscle Calm Capsicum Capsicum LOTION TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part348 Eco-Logics, Inc. CAPSICUM .25 mg/g E 20171231 30142-001_8e76d54a-98c8-46ca-98fa-f536ae805ffe 30142-001 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20110112 OTC MONOGRAPH FINAL part333D Kroger co SALICYLIC ACID 19.8 mg/g N 20181231 30142-003_79b5a2df-319b-4240-be2f-60b6cfad37b5 30142-003 HUMAN OTC DRUG Stool Softener plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 30142-004_50a79c59-f6fc-4bfd-b15e-86bd92c7c6fc 30142-004 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20130118 OTC MONOGRAPH FINAL part355 Kroger Co SODIUM FLUORIDE 10.4 mg/mL N 20191231 30142-005_a42f6689-cee6-4581-a608-de1b7b8b3bbb 30142-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Kroger Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 30142-009_ef8c23e4-39ae-42e0-bbdd-f5300c1a7a42 30142-009 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE ORAL 20100824 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM 100 mg/1 N 20181231 30142-011_00b95acb-1091-4a4f-9a14-0dc6c95119de 30142-011 HUMAN OTC DRUG sinus relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20150408 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 30142-012_952a353b-decf-fc54-4376-9e5626ede8cd 30142-012 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium 20.6mg Capsules CAPSULE, DELAYED RELEASE ORAL 20160101 ANDA ANDA078878 The Kroger Co. OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 30142-013_e27304da-de30-4eda-9025-39672d7b55a7 30142-013 HUMAN OTC DRUG Allergy and congestion relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120406 ANDA ANDA076050 Kroger Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 30142-014_2ef6229a-89bf-4b7b-8159-06ac2ddd050b 30142-014 HUMAN OTC DRUG Laxative pills Maximum Strength Sennosides TABLET ORAL 20130616 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. SENNOSIDES 25 mg/1 N 20181231 30142-015_4364fe9c-95e7-4681-a71d-f3ffe9ac0cc2 30142-015 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19900815 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL N 20181231 30142-017_092f2545-927f-4cb6-8ca0-39f6b21e4305 30142-017 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Kroger Company LORATADINE 5 mg/5mL N 20181231 30142-018_9b81f20f-687c-4e80-920f-4ef02e73454d 30142-018 HUMAN OTC DRUG Acetaminophen acetaminophen CAPSULE, LIQUID FILLED ORAL 20160426 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 325 mg/1 N 20181231 30142-019_669e8a0c-a33e-43dd-944c-2eff4df15c50 30142-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120901 ANDA ANDA202727 The Kroger Co. LANSOPRAZOLE 15 mg/1 N 20181231 30142-020_ec003514-6573-4355-9eba-bf1cec13de6c 30142-020 HUMAN OTC DRUG Diaper Rash ZINC OXIDE PASTE TOPICAL 20090515 OTC MONOGRAPH FINAL part347 Kroger Co ZINC OXIDE 532 mg/g N 20181231 30142-021_96d2897c-2a37-4b38-bda2-2395c01dc835 30142-021 HUMAN OTC DRUG nite time cold and cough childrens Diphenhydramine HCl, Phenylephrine HCl SOLUTION ORAL 20070829 OTC MONOGRAPH FINAL part341 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 30142-022_96e7f198-5dcc-4844-96f6-3ffcf1cf6736 30142-022 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20130701 OTC MONOGRAPH FINAL part347 Krogers LANOLIN; PETROLATUM 133; 459 mg/g; mg/g N 20181231 30142-023_7b356a15-9e4c-4c70-a325-6237b28a1b30 30142-023 HUMAN OTC DRUG Childrens Multi Symptom Fever and Cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20150623 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 30142-027_6f8b0cc6-1b30-4c2f-99be-ec8d34fc82d9 30142-027 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20130308 OTC MONOGRAPH NOT FINAL part343 The Kroger Co. ASPIRIN 81 mg/1 N 20181231 30142-028_4316df6e-3ae7-4ab5-e054-00144ff88e88 30142-028 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20140528 OTC MONOGRAPH FINAL part341 The Kroger Co. MENTHOL 7.5 mg/1 N 20181231 30142-028_4317f952-a229-0281-e054-00144ff88e88 30142-028 HUMAN OTC DRUG Honey Lemon cough drop Menthol LOZENGE ORAL 20140528 OTC MONOGRAPH FINAL part341 The Kroger Co. MENTHOL 7.5 mg/1 N 20181231 30142-028_4318f25a-05da-2208-e054-00144ff88e88 30142-028 HUMAN OTC DRUG Honey Lemon cough drop Menthol LOZENGE ORAL 20140528 OTC MONOGRAPH FINAL part341 The Kroger Co. MENTHOL 7.5 mg/1 N 20181231 30142-029_248b1135-a6b2-4af5-a9a4-f2e06f1088a8 30142-029 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20051215 ANDA ANDA076775 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-030_2be44c62-a9a3-5646-e054-00144ff8d46c 30142-030 HUMAN OTC DRUG Assort Fruit Panned calcium carbonate TABLET, CHEWABLE ORAL 20140718 OTC MONOGRAPH FINAL part331 Kroger CALCIUM CARBONATE 750 mg/1 N 20181231 30142-030_c51eecb0-ea35-4291-a1a0-90f43a36f0b6 30142-030 HUMAN OTC DRUG nausea relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20141209 UNAPPROVED DRUG OTHER Kroger Company DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 30142-031_42b257e9-f45f-32c9-e054-00144ff8d46c 30142-031 HUMAN OTC DRUG Menthol cough drop menthol LOZENGE ORAL 20140528 OTC MONOGRAPH FINAL part341 The Kroger Co. MENTHOL 5.4 mg/1 N 20181231 30142-032_4313a6ce-454e-4c4b-e054-00144ff88e88 30142-032 HUMAN OTC DRUG Cherry cough drop Menthol LOZENGE ORAL 20140528 OTC MONOGRAPH FINAL part341 The Kroget Co. MENTHOL 5.8 mg/1 N 20181231 30142-032_4314d74f-ace4-016f-e054-00144ff88e88 30142-032 HUMAN OTC DRUG Cherry cough drop menthol LOZENGE ORAL 20140528 OTC MONOGRAPH FINAL part341 The Kroger Co. MENTHOL 5.8 mg/1 N 20181231 30142-034_43281bd1-f8a8-02a4-e054-00144ff8d46c 30142-034 HUMAN OTC DRUG SF Honey Lemon Cough Drops Menthol LOZENGE ORAL 20140528 OTC MONOGRAPH FINAL part341 The Kroger Co. MENTHOL 7.6 mg/1 N 20181231 30142-035_432989f9-a2a0-58ef-e054-00144ff88e88 30142-035 HUMAN OTC DRUG Cherry Antacid Soft Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20130606 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 1177 mg/1 N 20181231 30142-036_437854c0-8c9b-6ef0-e054-00144ff8d46c 30142-036 HUMAN OTC DRUG Assorted Fruit Panned Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20151118 OTC MONOGRAPH FINAL part331 The Kroger Company CALCIUM CARBONATE 750 mg/1 N 20181231 30142-037_c531bac4-ab15-4fde-99a7-19e20ce10387 30142-037 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20170503 OTC MONOGRAPH FINAL part333B Kroger Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 30142-040_522a256b-a7c0-4783-bfff-3dc6b5a2b315 30142-040 HUMAN OTC DRUG Dual Action Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160201 ANDA ANDA077355 Kroger Company FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 30142-048_b61ec572-a96c-4896-8018-583535d0aae3 30142-048 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20150131 ANDA ANDA078682 The Kroger Co. IBUPROFEN 200 mg/1 N 20181231 30142-050_e603a218-3349-4f43-a195-ac64f7d9dcda 30142-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate and ibuprofen TABLET, FILM COATED ORAL 20090406 ANDA ANDA079113 Kroger Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 30142-054_7536543a-e4ec-4143-abb6-6b1093a221f5 30142-054 HUMAN OTC DRUG 12 hour decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19991214 ANDA ANDA075153 Kroger Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 30142-055_783e1ad5-3a7e-4291-b63f-99898b00d981 30142-055 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20141109 ANDA ANDA091353 The Kroger Co. NAPROXEN SODIUM 220 mg/1 N 20181231 30142-056_0c6436d8-d06a-42e5-b6b4-9bd38baad95c 30142-056 HUMAN OTC DRUG Nite Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140621 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 30142-057_b8655f7c-483d-4ad5-8a23-cb8e42916b47 30142-057 HUMAN OTC DRUG ibuprofen infants ibuprofen SUSPENSION ORAL 20021120 ANDA ANDA075217 Kroger Company IBUPROFEN 50 mg/1.25mL N 20181231 30142-060_756c6b45-704e-4684-96ba-4df3ef27552c 30142-060 HUMAN OTC DRUG Nicotine Mini Nicotine Polacrilex LOZENGE ORAL 20160212 ANDA ANDA203690 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-061_76bf588f-619d-4aa5-b379-98ba0d865ecb 30142-061 HUMAN OTC DRUG Allergy Relief fexofenadine hcl TABLET, FILM COATED ORAL 20110416 ANDA ANDA076447 Kroger Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 30142-063_b0fe42d7-b30c-4fde-80eb-786add6538d0 30142-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20090504 OTC MONOGRAPH FINAL part347 Kroger CO FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; g/mL N 20181231 30142-065_376218df-9f0a-4181-a1bf-896d51362b43 30142-065 HUMAN OTC DRUG nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 19940617 OTC MONOGRAPH FINAL part341 Kroger Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 30142-067_396ca5b7-01dc-40bf-9ccd-12586769eaaa 30142-067 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20130401 OTC MONOGRAPH NOT FINAL part334 Kroger Company BISACODYL 5 mg/1 N 20181231 30142-069_18828bbb-138f-4494-acc0-df24315d3630 30142-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Kroger Co PETROLATUM 1 g/g N 20191231 30142-070_97de57b2-9753-47b9-b2c3-974166406d00 30142-070 HUMAN OTC DRUG Antacid calcium carbonate TABLET ORAL 20101018 20190228 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 500 mg/1 E 20171231 30142-071_97de57b2-9753-47b9-b2c3-974166406d00 30142-071 HUMAN OTC DRUG Antacid calcium carbonate TABLET ORAL 20101018 20190228 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 500 mg/1 E 20171231 30142-072_5262b7e6-1e9a-4c1d-93dc-5b79f38a8e5c 30142-072 HUMAN OTC DRUG Mouth Rinse EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL MOUTHWASH ORAL 19891111 OTC MONOGRAPH NOT FINAL part356 Kroger EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 30142-073_106b0e48-6641-4974-862b-0e4ba0cff1d1 30142-073 HUMAN OTC DRUG Glazed Pear Ethyl Alcohol GEL TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Kroger, CO., ALCOHOL 62 mg/mL N 20181231 30142-074_946c573d-8d3f-425d-b468-a01ec93fa56b 30142-074 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 20060311 ANDA ANDA077349 Kroger Company IBUPROFEN 200 mg/1 N 20181231 30142-076_97de57b2-9753-47b9-b2c3-974166406d00 30142-076 HUMAN OTC DRUG Antacid calcium carbonate TABLET ORAL 20101018 20190228 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 750 mg/1 E 20171231 30142-078_79c7263b-2e33-4098-9337-5febfae48e79 30142-078 HUMAN OTC DRUG Castor Oil Castor Oil LIQUID ORAL 20010419 OTC MONOGRAPH NOT FINAL part334 Kroger Co CASTOR OIL 1 g/mL N 20181231 30142-079_0c04fed8-6cb0-4ff2-bb5d-5baa4bf4d2af 30142-079 HUMAN OTC DRUG KROGER WATERLESS HAND SANITIZER WITH ALOE ETHYL ALCOHOL LIQUID TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 700 mg/mL N 20181231 30142-079_3c4e13ad-750b-4236-a148-26995b35965d 30142-079 HUMAN OTC DRUG KROGER WATERLESS HAND SANITIZER WITH ALOE ETHYL ALCOHOL LIQUID TOPICAL 20140306 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 700 mg/mL N 20181231 30142-079_70d91270-772d-4271-b954-c6d65d2c87f9 30142-079 HUMAN OTC DRUG Kroger Waterless Hand Sanitizer with Aloe Ethyl Alcohol LIQUID TOPICAL 20170424 OTC MONOGRAPH NOT FINAL part333E The Kroger Company ALCOHOL 700 mg/mL N 20181231 30142-080_dc1c99c4-3f5b-4a8c-91b1-d5ab56cb0d1c 30142-080 HUMAN OTC DRUG Kroger Antifungal Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Kroger Company TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 30142-081_83c62e68-9994-4558-aa81-1c581c068a9d 30142-081 HUMAN OTC DRUG miconazole 3 Miconazole nitrate KIT 20000223 ANDA ANDA075329 Kroger Company N 20181231 30142-082_dfe6f1ef-78fa-4ded-8d8b-47c4bfa19300 30142-082 HUMAN OTC DRUG Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride CREAM TOPICAL 20080708 20180430 OTC MONOGRAPH NOT FINAL part347 Kroger Company NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g N 20181231 30142-084_b82a6322-49ff-481c-9c1b-836352758b6c 30142-084 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20160229 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 30142-085_af7e41bc-29be-4049-8310-fe0a455f7e9f 30142-085 HUMAN OTC DRUG Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Kroger Company LORATADINE 5 mg/5mL N 20181231 30142-088_6ea2f621-bd2e-4351-8f0d-9b01fd4c40bb 30142-088 HUMAN OTC DRUG Iodine Tincture Iodine tincture SOLUTION/ DROPS TOPICAL 20010621 OTC MONOGRAPH NOT FINAL part333A Kroger Co IODINE; SODIUM IODIDE 20; 20.4 mg/mL; mg/mL N 20181231 30142-090_37a8062e-4a8c-4c2d-87c4-1194b120a281 30142-090 HUMAN OTC DRUG DayTime Nite Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20070831 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-090_df8de516-bbf8-493c-ba50-9a918df730fe 30142-090 HUMAN OTC DRUG daytime nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110216 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-090_e002dcf1-5a4d-4412-9c51-5b2078a711fa 30142-090 HUMAN OTC DRUG NITE TIME DAYTIME MULTI SYMPTOM COLD/FLU Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130813 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-092_83c49382-642f-494f-b784-e4513b2c3bbf 30142-092 HUMAN OTC DRUG Childrens Non-Drowsy Allergy Relief 24-Hour Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Kroger Company LORATADINE 5 mg/5mL N 20181231 30142-094_3769c8a0-eb9a-497f-b6d1-30860973da89 30142-094 HUMAN OTC DRUG nasal decongestant pe non drowsy maximum strength Phenylephrine Hydrochloride TABLET ORAL 20050812 OTC MONOGRAPH FINAL part341 Kroger Company PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 30142-096_df0c97f1-c27b-4308-a356-f34feb72c685 30142-096 HUMAN OTC DRUG flu and severe cold and cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120117 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 30142-099_bf6580f4-f8f8-459f-bd64-95f2c12fc783 30142-099 HUMAN OTC DRUG Deep Cleaning Astringent Salicylic acid LIQUID TOPICAL 20150804 OTC MONOGRAPH FINAL part333D Krogers SALICYLIC ACID 18 mg/mL N 20181231 30142-101_df63c4b4-d7d2-4327-ad3d-f06fe59f4447 30142-101 HUMAN OTC DRUG Lice Complete Piperonyl butoxide, pyrethrum extract KIT 20160701 OTC MONOGRAPH FINAL part358G Kroger Company N 20181231 30142-102_db27dfd4-3100-49ea-a268-e6db694d5e24 30142-102 HUMAN OTC DRUG Childrens All Day Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Kroger Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 30142-103_ff27b735-85a3-4b38-98b3-b8a0d64efbfe 30142-103 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20110830 OTC MONOGRAPH NOT FINAL part343 The Kroger Co. ASPIRIN 81 mg/1 N 20181231 30142-104_aed620ff-565b-488a-bcc6-04d31842f76e 30142-104 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 The Kroger Co. ASPIRIN 81 mg/1 N 20181231 30142-105_74d6a62b-72b0-4248-85ee-be8f89f06e4a 30142-105 HUMAN OTC DRUG Pain Relief Childrens Acetaminophen SUSPENSION ORAL 20001214 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL N 20181231 30142-106_d6b4919d-21fa-41bb-ac8e-cf7c70a41104 30142-106 HUMAN OTC DRUG Childrens All Day Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Kroger Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 30142-107_74c52457-0992-4c3f-9227-272bd9d896a1 30142-107 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20100706 OTC MONOGRAPH FINAL part341 The Kroger Co. GUAIFENESIN 400 mg/1 N 20181231 30142-109_440cc9d4-81f6-4dd5-8277-9c3faed4df11 30142-109 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan Hydrobromide and Guaifenesin TABLET, COATED ORAL 20100102 OTC MONOGRAPH FINAL part341 The Kroger Co. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 30142-110_8c619728-0893-4276-86df-3426ea9189d2 30142-110 HUMAN OTC DRUG stool softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100712 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM 100 mg/1 N 20181231 30142-111_7d20996f-f241-444b-91e0-b31ef4d0d542 30142-111 HUMAN OTC DRUG Oral Saline Laxative Ginger Lemon dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120831 OTC MONOGRAPH NOT FINAL part334 The Kroger Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.7; 7.2 g/15mL; g/15mL E 20171231 30142-112_21318d98-c0c0-4d15-9a6f-2dd819f759f3 30142-112 HUMAN OTC DRUG Kroger DayTime Flu plus Severe Cold and Cough Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 30142-113_a63dc57c-8300-4005-a71b-fa059b7d5acb 30142-113 HUMAN OTC DRUG Kroger NiteTime Flu plus Severe Cold and Cough Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 30142-114_344ce783-deda-470c-b71a-8e3be41ba41b 30142-114 HUMAN OTC DRUG EZ Nite Sleep Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20141231 OTC MONOGRAPH FINAL part338 The Kroger Co. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 30142-117_01cd5ab0-de46-4f06-9203-5460f58efe11 30142-117 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 Kroger Company LANSOPRAZOLE 15 mg/1 N 20181231 30142-118_97de57b2-9753-47b9-b2c3-974166406d00 30142-118 HUMAN OTC DRUG Antacid calcium carbonate TABLET ORAL 20101018 20190131 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 1000 mg/1 E 20171231 30142-119_d16ec408-d77e-4a1e-b37d-06d019a16f01 30142-119 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170505 ANDA ANDA075077 Kroger Company ACETAMINOPHEN 650 mg/1 N 20181231 30142-120_e6ab3da6-8962-479b-ba46-ac88594d7e52 30142-120 HUMAN OTC DRUG womens laxative Bisacodyl TABLET, COATED ORAL 20110520 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. BISACODYL 5 mg/1 N 20181231 30142-121_ddd60389-5783-43cc-8734-5b2c6546d5a0 30142-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120511 ANDA ANDA202300 The Kroger Co IBUPROFEN 200 mg/1 N 20181231 30142-122_908222a8-1a7a-4322-ae08-c43042551f3d 30142-122 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120712 ANDA ANDA202300 The Kroger Co. IBUPROFEN 200 mg/1 N 20181231 30142-123_1143f968-8f9d-451a-a14a-b7b12c4d209a 30142-123 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120712 ANDA ANDA202300 The Kroger Co. IBUPROFEN 200 mg/1 N 20181231 30142-124_d5045ebc-f08d-4230-8ba0-1677acd850ba 30142-124 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 19980623 ANDA ANDA090711 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-125_6c87561e-fab9-4a0b-9f22-6e3093199947 30142-125 HUMAN OTC DRUG Tolnafate Foot and Sneaker Spray AEROSOL, SPRAY TOPICAL 20120102 OTC MONOGRAPH FINAL part333C Kroger Co. TOLNAFTATE 1.3 g/113g N 20181231 30142-126_d5e408e8-cccb-487a-a65b-cd62c0ac04e5 30142-126 HUMAN OTC DRUG Salicylic Acid Medicated Plantar Wart Remover PATCH TOPICAL 20120130 OTC MONOGRAPH FINAL part358B Kroger Co. SALICYLIC ACID 40 mg/241 N 20181231 30142-127_5b68d950-4aa4-4c8b-9c7c-b4520a394f23 30142-127 HUMAN OTC DRUG Salicylic Acid Wart Removers PATCH TOPICAL 20120112 OTC MONOGRAPH FINAL part358B Kroger Co. SALICYLIC ACID 40 mg/181 N 20181231 30142-128_934aed5a-ef97-4dd6-ab49-18cf8c507f54 30142-128 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20120112 OTC MONOGRAPH FINAL part358F Kroger Co. SALICYLIC ACID 40 mg/91 N 20181231 30142-129_4c652fd3-f436-43b9-b6f1-891633cd0d36 30142-129 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20120229 OTC MONOGRAPH FINAL part358F Kroger Co. SALICYLIC ACID 40 mg/41 N 20181231 30142-130_0a1dfa56-1eff-4f90-a8dd-5c1e193e13e8 30142-130 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19900815 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL N 20181231 30142-131_b0f0a762-dab2-e466-45bf-2b9e9bbd407d 30142-131 HUMAN OTC DRUG Ranitidine 75 Ranitidine Tablets USP, 75mg TABLET ORAL 20110331 ANDA ANDA075294 The Kroger Co. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 30142-134_493cfb02-b78d-4da3-b5d6-81f30ec47079 30142-134 HUMAN OTC DRUG Diphenhydramine HCl and Zinc Acetate Extra Strength Itch Relief SPRAY TOPICAL 20120229 OTC MONOGRAPH NOT FINAL part348 Kroger Co. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.52; .076 g/76g; g/76g N 20181231 30142-135_edcfaac0-caf4-4e86-98a1-495ef170fd7a 30142-135 HUMAN OTC DRUG Miconazole Nitrate Jock Itch Spray AEROSOL, SPRAY TOPICAL 20120229 OTC MONOGRAPH FINAL part333C Kroger Co. MICONAZOLE NITRATE 1.3 g/131g N 20181231 30142-140_97de57b2-9753-47b9-b2c3-974166406d00 30142-140 HUMAN OTC DRUG Antacid calcium carbonate TABLET ORAL 20101018 20190131 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 750 mg/1 E 20171231 30142-141_d6b7c83b-43d9-47af-a370-37a7f94008f2 30142-141 HUMAN OTC DRUG heartburn prevention original strength Famotidine TABLET ORAL 20091009 ANDA ANDA075400 Kroger Company FAMOTIDINE 10 mg/1 N 20181231 30142-142_4650fff7-f189-40ac-9ee2-29f102aae209 30142-142 HUMAN OTC DRUG Miconazole Nitrate Antifungal Liquid Continuous Spray AEROSOL, SPRAY TOPICAL 20171211 OTC MONOGRAPH FINAL part333C Kroger Co. MICONAZOLE NITRATE 2 g/150g N 20181231 30142-143_f27cf879-14c7-4ce3-8d8e-28819ec05800 30142-143 HUMAN OTC DRUG miconazole 7 Miconazole nitrate CREAM VAGINAL 19990428 ANDA ANDA074760 Kroger Company MICONAZOLE NITRATE 2 g/100g N 20181231 30142-144_23076826-beba-4f56-b298-6efa07adef98 30142-144 HUMAN OTC DRUG Mucus D Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20170420 ANDA ANDA091071 Kroger Company GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 30142-147_ed84305b-ec97-4c7e-a85f-1254070d384e 30142-147 HUMAN OTC DRUG Tolnaftate Antifungal Spray Liquid AEROSOL, SPRAY TOPICAL 20171206 OTC MONOGRAPH FINAL part333C Kroger Co. TOLNAFTATE 150 g/150g N 20181231 30142-148_a1d3315e-db65-4810-8981-bad10cfe47b7 30142-148 HUMAN OTC DRUG Kroger Sensitive Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Kroger Company SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 30142-149_6acdcf94-a2f4-4b74-a1d8-92921914d330 30142-149 HUMAN OTC DRUG Kroger Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Kroger SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 30142-150_91a3fc16-5b24-47d9-a528-e12fa5260ddc 30142-150 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20171206 OTC MONOGRAPH NOT FINAL part333A Kroger Co. BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/9mL; mg/9mL N 20181231 30142-151_95119019-0425-418a-8fb2-5e2412a35f8e 30142-151 HUMAN OTC DRUG Salicylic Acid Corn and Callus Remover Kit LIQUID TOPICAL 20171206 OTC MONOGRAPH FINAL part358F Kroger Co. SALICYLIC ACID .17 mg/9mL N 20181231 30142-152_66be8135-a23e-4740-96b1-6a1d613f191f 30142-152 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid LIQUID TOPICAL 20171206 OTC MONOGRAPH FINAL part358B Kroger Co. SALICYLIC ACID .17 mg/9mL N 20181231 30142-153_a32a31c8-7743-4fb9-ad81-d5b1f6d120b2 30142-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Kroger Co PYRITHIONE ZINC 1 kg/100L N 20181231 30142-156_0a370052-b7e2-406e-b67a-6ddd59f040d3 30142-156 HUMAN OTC DRUG Calamine Plus Pramoxine HCl Calamine Plus Spray AEROSOL, SPRAY TOPICAL 20171206 OTC MONOGRAPH NOT FINAL part348 Kroger Co. FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE .345; 24.16; 2.72 mg/116g; mg/116g; mg/116g N 20181231 30142-158_c5f276c2-f56c-43eb-b9bb-21f323d7f449 30142-158 HUMAN OTC DRUG nighttime sleep aid Doxylamine succinate TABLET ORAL 20140715 ANDA ANDA040167 Kroger Company DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 30142-160_1c03feda-7dfd-43f1-82cb-5e3af55500e6 30142-160 HUMAN OTC DRUG Senna- S docusate sodium and sennosides TABLET ORAL 20100712 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 30142-163_2c8f3138-a70b-4cd9-a8e9-58ea689b205d 30142-163 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20050912 OTC MONOGRAPH FINAL part355 Kroger SODIUM FLUORIDE 999.5 mL/100L N 20181231 30142-166_7ac8ba2e-547d-47ed-8f14-abc9e58bf02c 30142-166 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION ORAL 20021120 ANDA ANDA074937 Kroger Company IBUPROFEN 100 mg/5mL N 20181231 30142-167_4a340196-5385-43cc-98f5-01567d699359 30142-167 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110202 ANDA ANDA072199 The Kroger Co. IBUPROFEN 200 mg/1 N 20181231 30142-168_36453eb0-05da-4b06-8bbc-710693c7ade7 30142-168 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20110202 ANDA ANDA079096 The Kroger Co. NAPROXEN SODIUM 220 mg/1 N 20181231 30142-170_7f247899-e466-471a-a3cc-ae1fcfa51127 30142-170 HUMAN OTC DRUG nicotine polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20051215 ANDA ANDA076789 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-173_55ec8a32-0de0-4eee-8afc-08693790fb0d 30142-173 HUMAN OTC DRUG Lice Complete Kit Piperonyl Butoxide, Pyrethrum Extract KIT 20130726 OTC MONOGRAPH FINAL part358G Kroger Company N 20181231 30142-174_6ad4be8f-b082-46a2-8f80-1d27f4e487a7 30142-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141031 NDA NDA021920 The Kroger Co. NAPROXEN SODIUM 220 mg/1 N 20181231 30142-176_bdbe7bdc-4066-423d-9bc0-6fc3a87905d4 30142-176 HUMAN OTC DRUG all day allergy d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20140219 ANDA ANDA077170 Kroger Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 30142-177_059dffd7-1bea-4d34-9536-8c8afc0f8b92 30142-177 HUMAN OTC DRUG Naproxen Sodium Naproxen sodium TABLET, FILM COATED ORAL 20050208 ANDA ANDA074661 Kroger Company NAPROXEN SODIUM 220 mg/1 N 20181231 30142-178_97de57b2-9753-47b9-b2c3-974166406d00 30142-178 HUMAN OTC DRUG Antacid calcium carbonate TABLET ORAL 20101018 20190131 OTC MONOGRAPH FINAL part331 The Kroger Co. CALCIUM CARBONATE 750 mg/1 E 20171231 30142-179_8a9923e6-81f1-4fd5-b397-2e98af5db223 30142-179 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B sulfate OINTMENT TOPICAL 20080724 20180930 OTC MONOGRAPH FINAL part333B Kroger Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 30142-180_18d6b210-c155-49dd-9a6e-d6b39bce2835 30142-180 HUMAN OTC DRUG Healing petrolatum OINTMENT TOPICAL 19880215 OTC MONOGRAPH FINAL part347 The Kroger CO. PETROLATUM 340 mg/g N 20181231 30142-181_07b82bac-bbd2-4b79-864f-0b30d3c5ff57 30142-181 HUMAN OTC DRUG Menstrual Complete Acetaminophen, Caffeine, Pyrilamine maleate TABLET ORAL 20140328 OTC MONOGRAPH NOT FINAL part343 The Kroger Co. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 30142-182_3691aa6c-3140-4ada-b5a4-4220416ed3d4 30142-182 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 20001214 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL N 20181231 30142-183_779bf16d-2d69-4c9d-8169-dd10895ddc16 30142-183 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19930228 ANDA ANDA077349 Kroger Company IBUPROFEN 200 mg/1 N 20181231 30142-186_7240cf84-432c-40ad-966c-93a9c630f61f 30142-186 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20150630 ANDA ANDA076460 The Kroger Co. IBUPROFEN 200 mg/1 N 20181231 30142-188_0e617e0a-955a-463f-a26b-cc0df467b9e5 30142-188 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131213 OTC MONOGRAPH FINAL part346 Kroger Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 30142-189_85e1bc62-52de-48e5-b079-4b2e4dfc26b3 30142-189 HUMAN OTC DRUG childrens all day allergy Cetirizine HCl SOLUTION ORAL 20160310 ANDA ANDA204226 Kroger Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 30142-190_d50fd74d-a805-442c-b6d7-79cd0be5763c 30142-190 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20100914 ANDA ANDA090711 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-191_e98608f7-4c21-49ca-8a1a-1d61a943dbae 30142-191 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET, COATED ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. BISACODYL 5 mg/1 N 20181231 30142-194_d3fc7ccc-9c91-4581-845d-3d47d4aadb82 30142-194 HUMAN OTC DRUG heartburn prevention Famotidine TABLET ORAL 20150205 ANDA ANDA077351 Kroger Company FAMOTIDINE 20 mg/1 N 20181231 30142-198_d2ca9bf2-7ef7-4c39-bfa6-ba3604a1336f 30142-198 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20100701 ANDA ANDA078682 The Kroger Co. IBUPROFEN 200 mg/1 N 20181231 30142-199_120a2e22-8c72-4c78-a36d-85a3bba2a32f 30142-199 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100608 ANDA ANDA079114 Kroger Company N 20181231 30142-202_15060ca4-d3a2-418d-a51f-1deeb49bd008 30142-202 HUMAN OTC DRUG hair regrowth treatment for women minoxidil SOLUTION TOPICAL 20110205 ANDA ANDA075357 Kroger Company MINOXIDIL 2 g/100mL N 20181231 30142-203_8b379e7b-18ea-4dba-86e0-70c987d3db72 30142-203 HUMAN OTC DRUG Waterless Hand Sanitizer Alcohol GEL TOPICAL 19971212 OTC MONOGRAPH NOT FINAL part333A Kroger ALCOHOL .65 mL/100L N 20181231 30142-205_51f40e49-914b-4541-b763-eae1ae2aa49b 30142-205 HUMAN OTC DRUG Therapeutic T Plus Coal Tar SHAMPOO TOPICAL 20110331 OTC MONOGRAPH FINAL part358H The Kroger Co COAL TAR 5 mg/mL N 20181231 30142-206_540ba7e6-510f-4250-9d82-b74e0ab0bcbd 30142-206 HUMAN OTC DRUG nicotine stop smoking aid Nicotine Polacrilex GUM, CHEWING ORAL 20070129 ANDA ANDA078325 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-208_7295628f-3a9c-4e64-855b-0511aba64175 30142-208 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20170425 ANDA ANDA206394 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-209_965be729-d417-4ae6-a2a9-ed06c2287d42 30142-209 HUMAN OTC DRUG Nicotine Mini Nicotine Polacrilex LOZENGE ORAL 20160419 ANDA ANDA203690 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-211_6ff1092f-18a8-4c57-abbb-37d81b91c10c 30142-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20131230 NDA NDA022429 The Kroger Co. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 30142-213_bf2fcb88-418f-4d5d-85ba-ec165a53ab04 30142-213 HUMAN OTC DRUG Dual Action Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20160203 ANDA ANDA077355 Kroger Company FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 30142-218_db73ece7-34f6-49ea-a721-d4146dd5b21e 30142-218 HUMAN OTC DRUG Clear Anti Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 19940301 OTC MONOGRAPH FINAL part347 Kroger Co PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 30142-219_398e12f7-6d9f-4194-ad11-3acf0bbef3cc 30142-219 HUMAN OTC DRUG Blackhead Clearing Scrub Salicylic acid GEL TOPICAL 20140118 OTC MONOGRAPH FINAL part333D The Kroger Co. SALICYLIC ACID 19.4 mg/g N 20181231 30142-222_1ebf3108-e11c-4ec7-aec9-d8a748b3bc24 30142-222 HUMAN OTC DRUG Daytime Nitetime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20141103 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-225_c28cc203-7c00-47a0-a0ee-6462d3636ea3 30142-225 HUMAN OTC DRUG EZ Nite Sleep Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130411 OTC MONOGRAPH FINAL part338 The Kroger Co. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 30142-226_494710c8-6d9e-46d4-a48c-5f7a530efde3 30142-226 HUMAN OTC DRUG Creamy Diaper Rash Zinc Oxide OINTMENT TOPICAL 19940619 OTC MONOGRAPH FINAL part347 Kroger Co. ZINC OXIDE 13 kg/100kg N 20181231 30142-230_7b7a0cc8-f1e5-4629-9f16-ef8799fc150e 30142-230 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20100712 OTC MONOGRAPH FINAL part341 The Kroger Co DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 30142-231_73040112-231c-46ba-aa6a-0f00672a2055 30142-231 HUMAN OTC DRUG WATERLESS HAND SANITIZER ETHYL ALCOHOL GAS TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 62 mL/100mL N 20181231 30142-235_03a95371-c98c-4754-864a-ecf5e0ad5bce 30142-235 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20150630 ANDA ANDA076460 The Kroger Co. IBUPROFEN 200 mg/1 N 20181231 30142-236_11145a13-b140-42a9-96ea-b12fdf671a05 30142-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 The Kroger Co. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 30142-238_47c38eab-eaba-4248-a1de-1cc926883c14 30142-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM 100 mg/1 N 20181231 30142-242_ab83cff5-1ab5-4b41-b1e3-ad53a896974b 30142-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH FINAL part347 The Kroger Co. DIMETHICONE 125 mg/1 N 20181231 30142-243_6081dc7f-e2b6-4cd4-bf4b-7aa54921654e 30142-243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20090105 OTC MONOGRAPH FINAL part333A Kroger Co TRICLOSAN .15 kg/100L N 20181231 30142-244_f6d4e7e8-e98f-481d-a621-daa203d5050b 30142-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM 100 mg/1 N 20181231 30142-245_9ec31195-6752-4d5d-9f82-37dd97c2ac6c 30142-245 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. SENNOSIDES 25 mg/1 N 20181231 30142-246_60b33eae-34c9-43ad-8621-8066b6f9854e 30142-246 HUMAN OTC DRUG Medicated Dandruff Selenium sulfide SHAMPOO TOPICAL 19900115 OTC MONOGRAPH FINAL part358H KROGER Co SELENIUM SULFIDE 1 kg/100L N 20181231 30142-247_22291d87-6f80-48cc-a4c1-d81245ba32e4 30142-247 HUMAN OTC DRUG Advanced Healing Petrolatum OINTMENT TOPICAL 20121101 OTC MONOGRAPH FINAL part347 Kroger Co PETROLATUM 340 mg/100g N 20181231 30142-248_0132e151-3a66-4fc4-8234-d03f653671d2 30142-248 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090105 OTC MONOGRAPH FINAL part341 Kroger Co CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 48; 12; 26 kg/g; kg/g; kg/g N 20181231 30142-249_65aec907-f3ee-43c2-921e-c4629e5a6686 30142-249 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20140228 ANDA ANDA079174 The Kroger Co. IBUPROFEN 200 mg/1 N 20181231 30142-250_58bb1eb1-0039-498c-9ac3-b63d85d4b753 30142-250 HUMAN OTC DRUG cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20070908 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-251_eee9b174-c297-4e69-a4ed-5f1f01f39c46 30142-251 HUMAN OTC DRUG arthricream Trolamine Salicylate CREAM TOPICAL 19920204 OTC MONOGRAPH NOT FINAL part348 Kroger Company TROLAMINE SALICYLATE 10 g/100g N 20181231 30142-255_84670c6c-6913-4435-8d20-931635def21c 30142-255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20100515 ANDA ANDA075217 Kroger Company IBUPROFEN 50 mg/1.25mL N 20181231 30142-263_aebec369-aae6-4ff1-83e6-a36dca509bb4 30142-263 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20131217 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL N 20181231 30142-264_3ea04571-481a-46ec-bc7f-9c01bce02a04 30142-264 HUMAN OTC DRUG Daily Acne Control Cleanser Benzoyl peroxide CREAM TOPICAL 20140818 OTC MONOGRAPH FINAL part333D Kroger Inc BENZOYL PEROXIDE 104 mg/10g N 20181231 30142-272_e3fa1ff8-171f-433f-b384-e97115dd3bd5 30142-272 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070309 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 30142-274_bf05552d-af41-45a9-9fad-d9217f2e7caf 30142-274 HUMAN OTC DRUG aspirin low dose Aspirin TABLET, CHEWABLE ORAL 19970617 OTC MONOGRAPH NOT FINAL part343 Kroger Company ASPIRIN 81 mg/1 N 20181231 30142-279_c8b15ce4-da4c-4d62-b690-ca472065e8b2 30142-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140823 OTC MONOGRAPH FINAL part346 Kroger Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 30142-291_b8dc39e1-e03e-4db8-a76d-dba72aad9a49 30142-291 HUMAN OTC DRUG anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 20001004 UNAPPROVED DRUG OTHER Kroger Company DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 30142-294_ac7c492d-19cf-4fb2-94c9-98c8bbf66356 30142-294 HUMAN OTC DRUG hair regrowth treatment for men Minoxidil AEROSOL, FOAM TOPICAL 20120410 ANDA ANDA091344 Kroger Company MINOXIDIL 5 g/100g N 20181231 30142-296_8d3c7a20-be84-4afc-ab29-a839a969d599 30142-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20110401 OTC MONOGRAPH FINAL part358H The Kroger Co PYRITHIONE ZINC 10 mg/mL N 20181231 30142-299_5edc6a10-ad2a-4fb6-a6e9-fb3d9af03d5c 30142-299 HUMAN OTC DRUG Alcohol Free Antiseptic cetylpyridinium chloride MOUTHWASH ORAL 20090515 OTC MONOGRAPH NOT FINAL part356 Kroger Co CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 30142-301_82c5a01b-dc21-490f-86e9-1457320ca8aa 30142-301 HUMAN OTC DRUG 24 Hour Allergy Relief nasal Fluticasone propionate SPRAY, METERED NASAL 20160527 ANDA ANDA207957 Kroger Company FLUTICASONE PROPIONATE 50 ug/1 N 20181231 30142-302_cb9d2439-2597-46fb-9c51-055e98ceaa5e 30142-302 HUMAN OTC DRUG stomach relief original strength Bismuth subsalicylate SUSPENSION ORAL 19890115 OTC MONOGRAPH FINAL part335 Kroger Company BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 30142-303_7846dfc5-11e3-4fde-b6e0-ed0bf46f2964 30142-303 HUMAN OTC DRUG nasal Oxymetazoline hydrochloride SPRAY NASAL 20160621 OTC MONOGRAPH FINAL part341 Kroger Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 30142-304_34e78b87-9028-4db2-8e2d-9bb707d923b7 30142-304 HUMAN OTC DRUG Nasal oxymetazoline hydrochloride SPRAY NASAL 19901115 OTC MONOGRAPH FINAL part341 Kroger Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 30142-305_7a407ec8-ef2b-4fe2-836c-01154dcc4225 30142-305 HUMAN OTC DRUG Kroger ATHLETES FOOT Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Kroger Company CLOTRIMAZOLE 10 mg/g N 20181231 30142-306_58871602-ca60-40df-b60c-53b184ff2686 30142-306 HUMAN OTC DRUG gentle lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Kroger Company POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 30142-308_4f01ae48-5f49-49dd-860e-a0eabb6e3d08 30142-308 HUMAN OTC DRUG cold multi symptom severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20080820 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 30142-309_1d55fe3e-9c41-409f-8b1d-3c02688903e9 30142-309 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170425 ANDA ANDA206393 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-310_042aeb84-a11c-4e3a-810d-5b3806a2a8ee 30142-310 HUMAN OTC DRUG tussin adults non drowsy Guaifenesin SOLUTION ORAL 19911212 OTC MONOGRAPH FINAL part341 Kroger Company GUAIFENESIN 200 mg/10mL N 20181231 30142-311_fb6053bd-6070-475c-b080-f827b6c3df5e 30142-311 HUMAN OTC DRUG Everyday Clean Pyrithione Zinc SHAMPOO TOPICAL 20110401 OTC MONOGRAPH FINAL part358H Kroger Co PYRITHIONE ZINC 1 kg/100L N 20181231 30142-313_3c8599af-2ef8-4fad-a6cb-a694c8619018 30142-313 HUMAN OTC DRUG acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140519 ANDA ANDA075077 Kroger Company ACETAMINOPHEN 650 mg/1 N 20181231 30142-315_0712937e-cf2f-4a78-99f9-c885f300909b 30142-315 HUMAN OTC DRUG Flu Relief Cold and Chest Congestion ACETAMINOHPEN, GUAIFENESIN, PHENYLEPHRINE HCL LIQUID ORAL 20160229 OTC MONOGRAPH FINAL part341 The Kroger Co. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN 650; 10; 400 mg/30mL; mg/30mL; mg/30mL N 20181231 30142-317_dca3d19d-cfa2-4e3e-a8cf-f392cbd8eb9f 30142-317 HUMAN OTC DRUG Flu Relief Therapy Severe Cough and Cold Nighttime Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride LIQUID ORAL 20160131 OTC MONOGRAPH FINAL part341 The Kroger Co. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 30142-318_7c9f6b8a-3a91-4152-9276-321eb6971d9d 30142-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19910615 OTC MONOGRAPH NOT FINAL part356 Kroger Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 30142-319_ad24970b-f242-465f-9626-e4ceb2c3d670 30142-319 HUMAN OTC DRUG KROGER DAILY MOISTURIZING DIMETHICONE LIQUID TOPICAL 20150120 OTC MONOGRAPH FINAL part347 THE KROGER COMPANY DIMETHICONE 12 mg/mL N 20181231 30142-320_4d5d97c8-8902-4f50-a922-58fcfe1321ef 30142-320 HUMAN OTC DRUG Kroger Toothache Pain Relief Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B Kroger BENZOCAINE 20 g/100g N 20181231 30142-321_efb93229-06ce-4d2d-a3a3-6545c20f48bf 30142-321 HUMAN OTC DRUG Dual Action Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080909 ANDA ANDA077355 Kroger Company FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 30142-323_539b4b15-a41b-4397-8a59-a77748f4bc19 30142-323 HUMAN OTC DRUG Acid Reducer Cimetidine TABLET ORAL 20151021 ANDA ANDA075285 Kroger Company CIMETIDINE 200 mg/1 N 20181231 30142-325_1e2824f0-0c09-4163-8647-31b44e4ff349 30142-325 HUMAN OTC DRUG mucus er max Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160317 ANDA ANDA091009 Kroger Company GUAIFENESIN 1200 mg/1 N 20181231 30142-326_a62aa421-7286-4d6b-a7dd-65bbfc93509c 30142-326 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130801 OTC MONOGRAPH NOT FINAL part356 Kroger Co. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 30142-327_e0708482-5973-4090-9380-404c9249ca47 30142-327 HUMAN OTC DRUG lubricating relief Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20130222 OTC MONOGRAPH FINAL part349 Kroger Company POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 30142-332_52485af2-4446-4c75-ac63-588a99a2d4d8 30142-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19991020 OTC MONOGRAPH NOT FINAL part334 Kroger Company MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 30142-335_3679289d-f36f-4cd6-937d-bb2c3f15fc98 30142-335 HUMAN OTC DRUG nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110827 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 30142-337_edaf82b0-8b16-4e60-b424-b0ba30432f13 30142-337 HUMAN OTC DRUG stomach relief Bismuth subsalicylate SUSPENSION ORAL 19900915 OTC MONOGRAPH FINAL part335 Kroger Company BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 30142-338_dc02bb58-325a-48c8-aa60-9481bfe78b13 30142-338 HUMAN OTC DRUG moisturizing lubricant Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20130222 OTC MONOGRAPH FINAL part349 Kroger Company CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 30142-340_fe1bfdad-aaa4-4b30-ba18-551b762e3c83 30142-340 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED ORAL 20140211 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 N 20181231 30142-341_c74b72f9-82eb-4773-b81e-cf99122bd959 30142-341 HUMAN OTC DRUG Hydrocortisone Plus 12 Moisturizers Maximum Strength Hydrocortisone CREAM TOPICAL 20080701 20180430 OTC MONOGRAPH NOT FINAL part348 Kroger Company HYDROCORTISONE 1 g/100g N 20181231 30142-343_3410491e-1d1a-47e5-81ca-1287d5a899c6 30142-343 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20080724 20180630 OTC MONOGRAPH NOT FINAL part348 Kroger Company HYDROCORTISONE 1 g/100g N 20181231 30142-344_42124fcb-47b1-4e3a-901f-ae6bd1dd8840 30142-344 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20070427 ANDA ANDA077007 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-345_db52ea55-49f3-4f9d-86de-213ec7fc1c55 30142-345 HUMAN OTC DRUG severe sinus congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140514 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 30142-348_594ecbaa-eb52-4e8b-8616-861cf699f28b 30142-348 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET, SUGAR COATED ORAL 20030102 OTC MONOGRAPH NOT FINAL part334 Kroger Company SENNOSIDES 25 mg/1 N 20181231 30142-352_71f4e8c6-6cc6-4b60-9c8e-22f4be4dc582 30142-352 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070915 ANDA ANDA078547 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-357_ce2057f4-efa5-4195-9b83-80c9afc6e2e1 30142-357 HUMAN OTC DRUG Antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 19870715 OTC MONOGRAPH FINAL part331 Kroger Company ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 30142-358_5d512290-a6d4-499b-a368-878149850ac1 30142-358 HUMAN OTC DRUG sinus and allergy pe maximum strength Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20070406 OTC MONOGRAPH FINAL part341 Kroger Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 30142-359_13d52aaa-7112-485f-83b9-906007b46e41 30142-359 HUMAN OTC DRUG Tussin Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19911104 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 30142-361_96ae1edd-69e4-4650-9fe2-70db12a8e771 30142-361 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 N 20181231 30142-370_07f97c85-6c19-4e94-823d-c0f8e1f93ce7 30142-370 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20110110 OTC MONOGRAPH NOT FINAL part343 The Kroger Co. ASPIRIN 325 mg/1 N 20181231 30142-371_b4235cf4-8578-4803-b432-0a00474633a8 30142-371 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part335 The Kroger Co. BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 30142-372_d9a98fb0-033b-4339-bf1a-5cb89e5f49ef 30142-372 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20151031 OTC MONOGRAPH FINAL part335 The Kroger Co. BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 30142-373_d087343a-fc54-43dc-9cf5-6e8ea94db8eb 30142-373 HUMAN OTC DRUG Lubricant Eye carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20150601 OTC MONOGRAPH FINAL part349 The Kroger Co. CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL E 20171231 30142-374_01e7b7d8-cbb0-478e-9375-a6b0829218ac 30142-374 HUMAN OTC DRUG migraine formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20021120 ANDA ANDA075794 Kroger Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 30142-375_bd1dce2f-255c-4f68-9b6c-2c15c1d5f256 30142-375 HUMAN OTC DRUG EZ Nite Sleep Diphenhydramine HCl LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 The Kroger Co. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 30142-384_9d069cae-efc1-4ab5-bb2e-9cb77698b737 30142-384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120828 ANDA ANDA091135 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 30142-387_84b526a8-57bd-4c0b-a2c7-fadbda9b2c8e 30142-387 HUMAN OTC DRUG Childrens 24 Hour Allergy Relief Nasal Fluticasone Propionate SPRAY, METERED NASAL 20170227 ANDA ANDA207957 Kroger Company FLUTICASONE PROPIONATE 50 ug/1 N 20181231 30142-388_94f07da1-7987-4107-80f5-cef2e9ccba91 30142-388 HUMAN OTC DRUG nasal Oxymetazoline HCl SPRAY NASAL 20021120 OTC MONOGRAPH FINAL part341 Kroger Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 30142-396_39398bd9-5d7d-4518-8512-d4965aab7dd4 30142-396 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 19991020 OTC MONOGRAPH NOT FINAL part334 Kroger Company MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 30142-401_eeca8c38-e167-4f69-88fa-efd7307205d8 30142-401 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET ORAL 20121102 OTC MONOGRAPH FINAL part336 The Kroger Co. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 30142-403_b8503b89-716f-4231-a969-79f5d44fdf37 30142-403 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20140512 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 325 mg/1 N 20181231 30142-404_fa0e3978-e84c-4d2d-b631-0806a7e67167 30142-404 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine HCl SOLUTION ORAL 20140204 OTC MONOGRAPH FINAL part341 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 30142-405_7c4284bd-93b2-48bc-a89b-93a3f1579fac 30142-405 HUMAN OTC DRUG KROGER WATERLESS HAND SANITIZER CITRUS SCENT ETHYL ALCOHOL LIQUID TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 700 mg/mL N 20181231 30142-405_a45ba4fb-65f5-4ae6-a3af-97a2769bb048 30142-405 HUMAN OTC DRUG Kroger Waterless Hand Sanitizer Citrus Scent Ethyl Alcohol LIQUID TOPICAL 20170424 OTC MONOGRAPH NOT FINAL part333E The Kroger Company ALCOHOL 700 mg/mL N 20181231 30142-405_db4fe5ba-09ff-4cfb-914f-b47b2e46ed84 30142-405 HUMAN OTC DRUG KROGER WATERLESS HAND SANITIZER CITRUS SCENT ETHYL ALCOHOL LIQUID TOPICAL 20140325 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 700 mg/mL N 20181231 30142-408_67d96e61-ccb0-439b-84ae-97da50322f06 30142-408 HUMAN OTC DRUG Kroger Cold Sore Treatment Camphor CREAM TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part348 The Kroger Co. BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 30142-409_e1642134-00c1-4e83-aca2-c767d47a5ee9 30142-409 HUMAN OTC DRUG stay awake Caffeine TABLET ORAL 19940617 OTC MONOGRAPH FINAL part340 Kroger Company CAFFEINE 200 mg/1 N 20181231 30142-410_1223a6ea-61bf-4faa-af01-e65a5f43fc35 30142-410 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part333A Kroger Co ALCOHOL 585 mg/mL N 20181231 30142-411_fc1677f2-4078-4ebd-9c3b-86a29a35b489 30142-411 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20170413 OTC MONOGRAPH NOT FINAL part348 Kroger Company HYDROCORTISONE 1 g/100g N 20181231 30142-413_a79ba852-efbb-464f-8a1e-c31be6294979 30142-413 HUMAN OTC DRUG esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170922 ANDA ANDA207193 Kroger Company ESOMEPRAZOLE 20 mg/1 N 20181231 30142-416_49612c93-e8b2-4109-b27f-75fbdc076dd1 30142-416 HUMAN OTC DRUG Aspirin Regular Strength Aspirin TABLET ORAL 19871115 OTC MONOGRAPH NOT FINAL part343 Kroger Company ASPIRIN 325 mg/1 N 20181231 30142-419_c73982b0-252c-4280-8d90-959ecd3e3746 30142-419 HUMAN OTC DRUG childrens mucus relief cough Dextromethorphan hbr, Guaifenesin SOLUTION ORAL 20070926 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 30142-422_76494f6c-cfba-4227-81ac-69fd55de8913 30142-422 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070216 ANDA ANDA078326 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-423_0155c3f0-43e6-4469-b3c3-47262c417f22 30142-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 The Kroger Company IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 30142-430_ebb456a4-f37c-4966-b597-7f13014e33ac 30142-430 HUMAN OTC DRUG headache formula added strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19970130 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 30142-431_50ff17b0-df98-4f17-bb0e-b8dc8f44d75a 30142-431 HUMAN OTC DRUG nighttime sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20010205 OTC MONOGRAPH FINAL part338 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 30142-432_676ff02a-f128-46d1-9b31-bf0e0e2337e2 30142-432 HUMAN OTC DRUG nasal decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19870715 OTC MONOGRAPH FINAL part341 Kroger Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 30142-434_c764f099-86cf-4776-b6f9-8cce376132c3 30142-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130801 OTC MONOGRAPH NOT FINAL part356 Kroger Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 30142-435_99a6099c-26b0-4f8e-9bcf-2cb836cc4481 30142-435 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20150915 OTC MONOGRAPH FINAL part355 Kroger Co SODIUM FLUORIDE .2 mg/mL N 20181231 30142-439_39e66baa-2867-40ff-85e1-51f6779ca55b 30142-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A The Kroger CO. ALCOHOL 700 mg/mL N 20181231 30142-441_b743663b-5df6-4b00-b80f-372707124318 30142-441 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 19970502 ANDA ANDA040167 Kroger Company DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 30142-443_5e3affc2-9f1a-4408-a490-7aae78be3ed3 30142-443 HUMAN OTC DRUG 24 Hour Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20160410 ANDA ANDA078104 Kroger Company TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 30142-445_29055c13-c8bf-4e8c-987a-8a37cc2286d5 30142-445 HUMAN OTC DRUG Flu and Severe Cold and Cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140228 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 30142-447_87210e6e-8312-9d26-4381-b6836b9ab254 30142-447 HUMAN OTC DRUG Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE ORAL 20150422 ANDA ANDA076667 The Kroger Co. FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 N 20181231 30142-455_acc35132-4c6d-4c1f-af5d-3df741abf7f8 30142-455 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 20131214 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL N 20181231 30142-456_d60ad33a-a05e-4c62-9f56-5580febdc94b 30142-456 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070427 ANDA ANDA076777 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-458_76614050-e350-4c3a-b9da-8f1c4caf8081 30142-458 HUMAN OTC DRUG All Day Allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20080108 ANDA ANDA078336 Kroger Company CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20191231 30142-459_891c26d1-749a-492b-a387-59c18c255c22 30142-459 HUMAN OTC DRUG nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110826 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 30142-460_e932a8ed-4a61-42e4-9eb5-cd386bb64e32 30142-460 HUMAN OTC DRUG sinus congestion and pain Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20150610 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 30142-461_65255b22-4fda-4338-aadd-8c6c3c740780 30142-461 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20040510 ANDA ANDA076359 Kroger Company IBUPROFEN 100 mg/1 N 20181231 30142-462_4d660f71-93bc-4283-9e5b-6d8c41f9fc6e 30142-462 HUMAN OTC DRUG allergy diphenhydramine hydrochloride CAPSULE ORAL 19900815 OTC MONOGRAPH FINAL part341 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 30142-467_27e0753f-2d1c-452f-a1c7-25f3743e643d 30142-467 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19921006 OTC MONOGRAPH NOT FINAL part343 Kroger Company ASPIRIN 81 mg/1 N 20181231 30142-469_e3fcaa86-a1d4-41ff-80bf-85bb9e1168bd 30142-469 HUMAN OTC DRUG Stomach relief chewables Bismuth subsalicylate TABLET, CHEWABLE ORAL 19911010 OTC MONOGRAPH FINAL part335 Kroger Company BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 30142-475_9526b509-40fb-4bab-b7b5-13ab600b728a 30142-475 HUMAN OTC DRUG Childrens All Day Allergy Cetirizine HCl SOLUTION ORAL 20151023 ANDA ANDA204226 Kroger Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 30142-476_ee11fbd3-4d95-4e3e-9e43-fd41f30092db 30142-476 HUMAN OTC DRUG allergy multi symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20060821 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 30142-477_65a77997-8ab5-419f-8ed5-7af3972a8b22 30142-477 HUMAN OTC DRUG fiber laxative Calcium polycarbophil TABLET, FILM COATED ORAL 19970207 OTC MONOGRAPH NOT FINAL part334 Kroger Company CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 30142-479_38e5d2f9-51aa-4b17-9bfe-076b4f4f5187 30142-479 HUMAN OTC DRUG Allergy Diphenhydramine Hydrochloride TABLET ORAL 19870915 OTC MONOGRAPH FINAL part341 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 30142-482_57aff23e-bfd5-4014-ba9b-bdcf4803d64d 30142-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20140507 OTC MONOGRAPH FINAL part355 The Kroger Co SODIUM FLUORIDE .1 mg/mL N 20181231 30142-483_aff6f58b-cdc5-476a-9899-42c16f453b13 30142-483 HUMAN OTC DRUG Allergy Relief Dye Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20161231 OTC MONOGRAPH FINAL part341 The Kroger Co. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 30142-485_c024370f-4fc2-447d-b43e-8fde77957332 30142-485 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20160229 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 30142-487_b2e57afd-2777-4b07-a4bc-d4450db790be 30142-487 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20160630 OTC MONOGRAPH FINAL part347 The Kroger Co. DIMETHICONE 125 mg/1 N 20181231 30142-492_03520cd6-3573-4387-a5ce-6ab779325104 30142-492 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20160531 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. SENNOSIDES 25 mg/1 N 20181231 30142-498_64185a96-b80f-4abf-a842-4183dc05619f 30142-498 HUMAN OTC DRUG mucus er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130318 ANDA ANDA078912 Kroger Company GUAIFENESIN 600 mg/1 N 20181231 30142-500_776899ea-0b82-44c7-b277-f3fc2b5f2b6d 30142-500 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140306 ANDA ANDA074661 Kroger Company NAPROXEN SODIUM 220 mg/1 N 20181231 30142-501_de10ad33-22fb-4926-bf8c-1e9fbb66a0ff 30142-501 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20120223 OTC MONOGRAPH FINAL part333B Kroger Company BACITRACIN ZINC 500 [USP'U]/g N 20181231 30142-502_408675a3-a6d7-4ccc-bbbf-e0ee0c270f74 30142-502 HUMAN OTC DRUG Patch Kroger Menthol PATCH TOPICAL 20140808 OTC MONOGRAPH NOT FINAL part348 Kroger MENTHOL 775 mg/1 N 20181231 30142-503_f032d5b2-f323-4d7d-be1d-4d51ad8a6b05 30142-503 HUMAN OTC DRUG Allergy Relief Chlorpheniramine Maleate TABLET ORAL 19870715 OTC MONOGRAPH FINAL part341 Kroger Company CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 30142-505_d6e047f7-2741-7dd6-d18c-ae738cd70f0e 30142-505 HUMAN OTC DRUG Heratburn Relief Ranitidine TABLET, COATED ORAL 20110424 ANDA ANDA078192 The Kroger Co. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 30142-506_8346a794-3a19-4140-9d06-e7642c03dbf4 30142-506 HUMAN OTC DRUG fast cold and flu relief Acetaminophen, dextromethorphan HBr, Guaifenesin, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20170622 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 30142-507_7b71e323-1eb6-4fc2-9597-2f5d576fe568 30142-507 HUMAN OTC DRUG Acetaminophen Acetaminophen CAPSULE, COATED ORAL 20150818 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 N 20181231 30142-510_2ec8f755-9215-40a1-9eaa-6b4b16f827b4 30142-510 HUMAN OTC DRUG Kroger Jock Itch Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Kroger Company CLOTRIMAZOLE 10 mg/g N 20181231 30142-511_c8bd1239-41cf-4cff-97c6-5e1357a8696e 30142-511 HUMAN OTC DRUG fast mucus relief Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20140730 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 30142-516_ed3e75e6-ce9f-4aa7-8582-c0268dddfb76 30142-516 HUMAN OTC DRUG tussin cf non drowsy Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 19890915 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 30142-517_c6cf28ca-16e7-46d4-9ec8-6d4f8f1a25c5 30142-517 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060427 ANDA ANDA077349 Kroger Company IBUPROFEN 200 mg/1 N 20181231 30142-519_f4cb5ad5-c8d8-4c81-a08e-443c00b6178d 30142-519 HUMAN OTC DRUG KROGER MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20140624 OTC MONOGRAPH FINAL part358H THE KROGER COMPANY SELENIUM SULFIDE 10 mg/mL N 20181231 30142-520_07610eca-5576-45b1-b6d6-fd3e51bf6352 30142-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20161231 NDA NDA021855 The Kroger Co. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 30142-521_cc387ca5-44de-48ec-b858-22427aa269b7 30142-521 HUMAN OTC DRUG junior strength ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20170425 ANDA ANDA076359 Kroger Company IBUPROFEN 100 mg/1 N 20181231 30142-525_3442ec31-e623-4909-ae10-7da628d9338e 30142-525 HUMAN OTC DRUG Anti-Itch Extra Strength diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20090126 OTC MONOGRAPH NOT FINAL part348 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 30142-527_cce01c35-4677-45cd-833c-8db241dccdb5 30142-527 HUMAN OTC DRUG Childrens Allergy Relief Fexofenadine Hydrochloride SUSPENSION ORAL 20150701 ANDA ANDA203330 Kroger Company FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 30142-530_9c1d06ba-3788-4719-b4a6-7249f35504af 30142-530 HUMAN OTC DRUG acetaminophen pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20151223 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 30142-532_86f1e4f6-8146-468c-9141-97311d48c46e 30142-532 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070427 ANDA ANDA076779 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-533_dea12fc8-cd7f-407e-8f66-0edbaec4ca3b 30142-533 HUMAN OTC DRUG athletes foot Tolnaftate CREAM TOPICAL 20120126 OTC MONOGRAPH FINAL part333C Kroger Company TOLNAFTATE 1 g/100g N 20181231 30142-536_b1886ad2-c5ac-4815-b836-f421b0a388e9 30142-536 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20170419 OTC MONOGRAPH FINAL part333B Kroger Company BACITRACIN 500 [USP'U]/g N 20181231 30142-539_fe8375f7-ca35-4231-bcab-93474f691a3d 30142-539 HUMAN OTC DRUG nasal Phenylephrine hydrochloride SPRAY NASAL 20140218 OTC MONOGRAPH FINAL part341 Kroger Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 30142-541_27a314f0-c541-4333-9ad7-389b8d9339b3 30142-541 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part348 Kroger Company HYDROCORTISONE 1 g/100g N 20181231 30142-544_37228738-57a4-4d3d-af15-e4525c4589b7 30142-544 HUMAN OTC DRUG arthritis pain relief temporary minor Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000606 ANDA ANDA075077 Kroger Company ACETAMINOPHEN 650 mg/1 N 20181231 30142-546_9cb8d0ea-cb24-4006-95b6-73703f3c8991 30142-546 HUMAN OTC DRUG Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20081009 ANDA ANDA077355 Kroger Company FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 30142-548_17061a42-a04c-4697-84d5-851dc042123f 30142-548 HUMAN OTC DRUG daytime severe cold and flu acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140822 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 30142-550_f6502735-ba3e-4817-94cf-508fd46c7a07 30142-550 HUMAN OTC DRUG Gas Relief SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100313 OTC MONOGRAPH FINAL part332 The Kroger Co DIMETHICONE 125 mg/1 N 20181231 30142-555_6ea5fb69-5e90-49bd-8b99-024e898344dd 30142-555 HUMAN OTC DRUG Allergy Relief Fexofenadine HCl TABLET, FILM COATED ORAL 20131219 ANDA ANDA076447 Kroger Company FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 30142-557_5f801b57-fd31-4228-ad1b-feffa83a298d 30142-557 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080225 NDA NDA022032 Kroger Company OMEPRAZOLE 20 mg/1 N 20181231 30142-561_5028438e-ad14-447e-b51e-f3a029ce2afb 30142-561 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 N 20181231 30142-562_be44b844-ae5e-4314-9dd2-c6d5bf87149d 30142-562 HUMAN OTC DRUG Ultra Chloroxylenol 0.3% LIQUID TOPICAL 20150429 OTC MONOGRAPH NOT FINAL part333A Kroger Co CHLOROXYLENOL 3.09 g/mL N 20181231 30142-563_b37f34ae-da59-455f-b879-83bd0f1adb63 30142-563 HUMAN OTC DRUG Kroger Kids Anticavity Fluoride Mixed Berry Sodium Fluoride LIQUID ORAL 20170120 OTC MONOGRAPH FINAL part355 The Kroger Company SODIUM FLUORIDE .2 mg/mL N 20181231 30142-567_0100f3be-972a-49c1-b6e3-da6d00944540 30142-567 HUMAN OTC DRUG NiteTime DayTime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20111112 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-567_a8641392-70f5-4801-a893-c41ad6970a46 30142-567 HUMAN OTC DRUG Nite Time Day Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130920 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-575_e916cb80-de5f-48a5-b842-474fb4775b8f 30142-575 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part333A The Kroger Co., BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 30142-576_e0731ad2-7c83-4552-9468-dc661fa93b0c 30142-576 HUMAN OTC DRUG Oral Antivavity Sodium fluoride MOUTHWASH ORAL 20150206 OTC MONOGRAPH FINAL part355 Kroger Co SODIUM FLUORIDE 10.41 mg/mL N 20181231 30142-578_a46cb957-a7c2-461d-8ece-a4ef8e300865 30142-578 HUMAN OTC DRUG tussin dm adults Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19941103 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 30142-580_12897e27-df23-4d6d-b6f9-433f354b56fe 30142-580 HUMAN OTC DRUG Daytime Nitetime Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140531 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-582_067e718a-ec0b-4895-8f9f-82d64ab4c7b4 30142-582 HUMAN OTC DRUG anti itch Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20170330 OTC MONOGRAPH NOT FINAL part348 Kroger Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 30142-584_09927ce3-2483-49b5-82a0-b679067bbb94 30142-584 HUMAN OTC DRUG Stool Softener Laxative Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20171031 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM 100 mg/1 N 20181231 30142-588_ce7adaf4-ba93-401e-911a-0bd41549a32b 30142-588 HUMAN OTC DRUG antacid Aluminum Hydroxide, Magnesium Hydroxide, Simethicone SUSPENSION ORAL 20120514 OTC MONOGRAPH FINAL part332 Kroger Company ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 30142-589_99cf27e7-f6f6-4e13-a059-ca2e01f5cfcb 30142-589 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20170110 OTC MONOGRAPH NOT FINAL part333A Krogers ALCOHOL 545 mg/mL N 20181231 30142-590_02b5081c-adec-4dca-bc7a-8b659775342b 30142-590 HUMAN OTC DRUG pain and fever acetaminophen SUSPENSION ORAL 19930331 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL N 20181231 30142-593_236a9447-23ec-44c7-a241-20f9ddc83ab8 30142-593 HUMAN OTC DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20170209 NDA NDA022032 Kroger Company OMEPRAZOLE 20 mg/1 N 20181231 30142-596_fd0f81f6-5b5f-4c27-ad73-3a7dbbd344ee 30142-596 HUMAN OTC DRUG Hand Sanitizer Ethyl alcohol GEL TOPICAL 20120917 OTC MONOGRAPH NOT FINAL part333A The Kroger Co ALCOHOL 700 mg/mL N 20181231 30142-597_d6ac1fb3-3ad6-4bb9-b7d3-7b052a712aad 30142-597 HUMAN OTC DRUG NiteTime DayTime Severe Cold and Flu acetaminophen, dextromethorphan HBr, doxylamine succinate, guaifenesin, phenylephrine HCl KIT 20140924 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-600_3b5ed5ee-4086-478a-be65-736df25fd6c6 30142-600 HUMAN OTC DRUG heartburn relief 150 Ranitidine TABLET, FILM COATED ORAL 20130831 ANDA ANDA091429 Kroger Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 30142-601_7f18ff4d-29da-4c6b-ab50-36c765957d92 30142-601 HUMAN OTC DRUG home sense Benzalkonium chloride CLOTH TOPICAL 20130509 OTC MONOGRAPH NOT FINAL part333A The Kroger Co. BENZALKONIUM CHLORIDE .115 g/1 N 20181231 30142-602_6037ffe0-1c73-4fd6-bede-fb965ecb81b4 30142-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 19931021 OTC MONOGRAPH NOT FINAL part334 Kroger Co. MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 30142-603_059f2aa3-8404-4dea-aeb6-6ee8791c0f7e 30142-603 HUMAN OTC DRUG daytime severe cold and flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20141010 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 30142-604_12af9a00-a7c3-48b4-b18f-8d9462a435f7 30142-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET ORAL 19880115 ANDA ANDA072096 Kroger Company IBUPROFEN 200 mg/1 N 20181231 30142-612_4ecd2582-97c5-45fe-94a6-a0abcce9295a 30142-612 HUMAN OTC DRUG Allergy Relief Loratadine TABLET ORAL 20050822 ANDA ANDA076301 Kroger Company LORATADINE 10 mg/1 N 20191231 30142-617_38f5a11f-3353-4b27-b17a-a64fe3e2eaf5 30142-617 HUMAN OTC DRUG naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 19970116 ANDA ANDA074661 Kroger Company NAPROXEN SODIUM 220 mg/1 N 20181231 30142-619_f6f2167f-0a71-4c22-866c-31e3711aff9a 30142-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 19870715 OTC MONOGRAPH FINAL part347 Kroger DIMETHICONE 13 mg/mL N 20181231 30142-620_803b8c5d-a355-431e-8bbf-4d850127e10c 30142-620 HUMAN OTC DRUG Motion sickness Meclizine HCl TABLET ORAL 20100711 OTC MONOGRAPH FINAL part336 The Kroger Co. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 30142-621_17de1602-1e38-4345-b7b4-4dfc8e962c3f 30142-621 HUMAN OTC DRUG Kroger Company Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20140224 OTC MONOGRAPH FINAL part355 Kroger Company SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 30142-622_2fa96b11-901d-4eba-b603-e2f95bede143 30142-622 HUMAN OTC DRUG Cranberry Garland Ethyl Alcohol GEL TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Kroger, CO., ALCOHOL 62 mg/mL N 20181231 30142-623_29a96d29-99e0-4113-ad0b-9a46af1d6111 30142-623 HUMAN OTC DRUG Cold Multi Symptom Acetaminophen, Dextromethorphan hbr, Phenylephrine hcl TABLET, FILM COATED ORAL 20150904 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 30142-628_c5700773-029e-4db3-981b-67efe3cd4ebb 30142-628 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140826 OTC MONOGRAPH NOT FINAL part333A The Kroger Co., BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 30142-636_da854704-6d93-4736-8fb0-b021455357b6 30142-636 HUMAN OTC DRUG fast cold and flu relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20170622 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 30142-640_32df3a90-d93f-41dc-9a17-f6e2ccafa44f 30142-640 HUMAN OTC DRUG Urinary Pain Relief Phenazopyridine Hydrochloride TABLET ORAL 20120511 UNAPPROVED DRUG OTHER The Kroger Co PHENAZOPYRIDINE 95 mg/1 N 20181231 30142-645_ee44cf26-0908-48cf-8dc8-08c423fbadd7 30142-645 HUMAN OTC DRUG Loperamide Hydrochloride loperamide HCl SUSPENSION ORAL 20130806 ANDA ANDA091292 Kroger Company LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 30142-647_224f17e6-12c0-4749-92dc-7c96596943c0 30142-647 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 19901015 ANDA ANDA072096 Kroger Company IBUPROFEN 200 mg/1 N 20181231 30142-650_2046f5aa-a075-4513-9392-43b7e2f79f3c 30142-650 HUMAN OTC DRUG Allergy Relief Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20140128 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 30142-655_0b93e831-5e46-4f94-a1ae-10f5acb32717 30142-655 HUMAN OTC DRUG KROGER KIDS TEAR FREE SPF50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20160105 OTC MONOGRAPH NOT FINAL part352 Kroger Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 6 g/100g; g/100g; g/100g; g/100g N 20181231 30142-656_61b938bf-6546-4e01-b866-0e1ae438b3b0 30142-656 HUMAN OTC DRUG Day Time acetaminophen, dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20060611 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 30142-657_b14313a8-c3e0-46a2-9cd8-7936af1cfaef 30142-657 HUMAN OTC DRUG gas relief Simethicone CAPSULE, LIQUID FILLED ORAL 20030124 OTC MONOGRAPH FINAL part332 Kroger Company DIMETHICONE 180 mg/1 N 20181231 30142-660_4cead69e-6f0e-4d6a-92f7-a52055b6d4bb 30142-660 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20021120 ANDA ANDA074937 Kroger Company IBUPROFEN 100 mg/5mL N 20181231 30142-663_ea01ada1-d36e-4cab-b1dd-a5356860d175 30142-663 HUMAN OTC DRUG Crisp Apple Hand Sani Ethyl Alcohol LIQUID TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part333A Kroger ALCOHOL 585 g/mL N 20181231 30142-664_fb28ce43-2810-48e2-a6da-2a8e9544e9ca 30142-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19940805 OTC MONOGRAPH NOT FINAL part356 Kroger CO. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 30142-668_454d3431-78d8-42b1-be3f-ed1136e82a25 30142-668 HUMAN OTC DRUG NiteTime Cough Dextromethorphan Hydrobromide, Doxylamine Succinate SOLUTION ORAL 20021120 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 30142-670_3668ae5b-d3c3-4f47-ace9-c7a39f55e1ab 30142-670 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20110202 OTC MONOGRAPH FINAL part341 The Kroger Co. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 30142-679_e31c8d92-bf9f-4b7f-8f81-54199745cd20 30142-679 HUMAN OTC DRUG Triple Antibiotic plus pain relief Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20170427 OTC MONOGRAPH FINAL part333B Kroger Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 30142-685_7e893e32-7cbd-4dc3-8e22-d3bbc4187861 30142-685 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20110425 ANDA ANDA074937 Kroger Company IBUPROFEN 100 mg/5mL N 20181231 30142-686_cd016219-83fa-4c48-b821-287b9157fdef 30142-686 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20120719 OTC MONOGRAPH FINAL part334 Kroger Co MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 30142-688_ac878610-95bd-49fb-89d2-3b718133ded7 30142-688 HUMAN OTC DRUG Sinus Relief Acetaminophen, guaifenesin, diphenhydramine HCl, phenylephrine HCl KIT 20150410 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-690_5023f272-34b2-4cfe-a049-128285349612 30142-690 HUMAN OTC DRUG Kroger Sheer dry-touch SFP 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160308 OTC MONOGRAPH NOT FINAL part352 Krogers AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 8; 5; 4; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-692_29ddce2c-7691-4d48-b243-fde623b220de 30142-692 HUMAN OTC DRUG cool heat Menthol, Methyl salicylate CREAM TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part348 Kroger Company MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 30142-693_6c530c35-5f04-4687-8dfb-45224d54698d 30142-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20010503 OTC MONOGRAPH NOT FINAL part334 The Kroger Co MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 30142-700_785b8665-9c67-4290-ad48-3c43abb1cbab 30142-700 HUMAN OTC DRUG acetaminophen pm Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20140801 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 30142-701_2425be2e-74c4-49b5-88d9-040d53cd355f 30142-701 HUMAN OTC DRUG Mucus Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170907 NDA NDA021282 KROGER COMPANY GUAIFENESIN 600 mg/1 N 20181231 30142-702_11639a38-75b3-4633-8c7d-f0e12f670537 30142-702 HUMAN OTC DRUG Eye Itch Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140122 ANDA ANDA077958 Kroger Company KETOTIFEN FUMARATE .35 mg/mL N 20181231 30142-703_beccd9ea-d8bc-4b86-95ae-a63411604415 30142-703 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170821 NDA NDA021282 KROGER COMPANY GUAIFENESIN 1200 mg/1 N 20181231 30142-704_390d56c2-92dd-4212-afd1-f726d2281074 30142-704 HUMAN OTC DRUG daytime cold and flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20140930 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 30142-705_772bca5f-8075-4564-9cf6-a888d3dfe53a 30142-705 HUMAN OTC DRUG Illuminating Daily Moisturizer Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120517 OTC MONOGRAPH NOT FINAL part352 The Kroger Co. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mL/100mL; mL/100mL; mL/100mL N 20181231 30142-706_4a10dc87-8a4f-435d-aaf4-f2d3902b4e0a 30142-706 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20170905 NDA NDA021620 KROGER COMPANY GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 30142-707_e3b6afef-7f31-43ec-ae74-43957c33b7d3 30142-707 HUMAN OTC DRUG fast mucus relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140923 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 30142-709_e106f743-1ac0-4f10-9b4b-fb6945b70124 30142-709 HUMAN OTC DRUG nausea relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20170130 UNAPPROVED DRUG OTHER Kroger Company DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20191231 30142-711_22de3ff5-6e36-4658-a854-af857e712c9a 30142-711 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160112 OTC MONOGRAPH FINAL part352 The Kroger Co AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 72.1; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; 1/mL N 20181231 30142-724_3f692738-ebdc-41b4-8e04-65db5d12349f 30142-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 The Kroger Company LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 30142-729_607fe7b8-e65f-4285-870c-1d41f29ab31d 30142-729 HUMAN OTC DRUG KROGER DAILY FACE WASH SALICYLIC ACID LIQUID TOPICAL 20140922 OTC MONOGRAPH FINAL part333D THE KROGER COMPANY SALICYLIC ACID 20 mg/mL N 20181231 30142-733_0d505f7e-b1e6-422d-a047-7cfbb2b322f7 30142-733 HUMAN OTC DRUG NiteTime DayTime acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20111112 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-733_5f680d8f-3611-44fc-94a2-881a8e3d8a1c 30142-733 HUMAN OTC DRUG Nite Time Day Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130914 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-734_e738441f-48ae-47c8-9e32-622f98d32045 30142-734 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130509 ANDA ANDA203690 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-735_89bd3b97-f898-486d-b223-cde5e23b2528 30142-735 HUMAN OTC DRUG Mucus DM Max Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160701 ANDA ANDA091070 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 30142-737_ba5a2121-49b4-483f-95e3-2db9071e6881 30142-737 HUMAN OTC DRUG Miconazole 1 Miconazole nitrate KIT 20130723 ANDA ANDA079114 Kroger Company N 20181231 30142-744_754d8962-3990-4096-9ced-7aab57d7bce8 30142-744 HUMAN OTC DRUG Antibiotic Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20170508 OTC MONOGRAPH FINAL part333B Kroger Company NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g N 20191231 30142-763_720198c0-7be8-4dd8-8bdc-1d422a983bdc 30142-763 HUMAN OTC DRUG NiteTime Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140813 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 30142-764_96b99f05-f259-482e-8d41-2124d2847a66 30142-764 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160112 OTC MONOGRAPH FINAL part352 The Kroger Co AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.6; 119; 45.9; 45.9; 55.08 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 30142-766_d32ae616-c8f9-478c-ae0a-8f16df90f1ef 30142-766 HUMAN OTC DRUG infants pain and fever Acetaminophen SUSPENSION ORAL 20120315 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL N 20181231 30142-769_38333a87-dd77-4ffc-bde3-e347aa6be8e1 30142-769 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20160112 OTC MONOGRAPH FINAL part352 The Kroger Co AVOBENZONE; HOMOSALATE; OCTISALATE 30.3; 101; 30.3 mg/mL; mg/mL; mg/mL N 20181231 30142-770_d0ca4f20-a1e6-45ea-ab3c-dc35bec3ef23 30142-770 HUMAN OTC DRUG Itchy Eye Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140122 ANDA ANDA077958 Kroger Company KETOTIFEN FUMARATE .35 mg/mL N 20181231 30142-771_36817db5-4b20-7288-e054-00144ff88e88 30142-771 HUMAN OTC DRUG Kroger Cough Cold and Flu Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20160407 OTC MONOGRAPH FINAL part341 THE KROGER CO CHOLINE SALICYLATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 870; 10; 20; 200 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 30142-772_3685e6fe-e002-103b-e054-00144ff88e88 30142-772 HUMAN OTC DRUG Kroger NiteTime Cold and Flu Choline Salicylate, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride LIQUID ORAL 20160407 OTC MONOGRAPH FINAL part341 THE KROGER CO DIPHENHYDRAMINE HYDROCHLORIDE; CHOLINE SALICYLATE; PHENYLEPHRINE HYDROCHLORIDE 50; 870; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 30142-773_3685d9f3-5ab2-2e0d-e054-00144ff8d46c 30142-773 HUMAN OTC DRUG Kroger Allergy Relief Chlophedianol Hydrochloride, Pyrilamine Maleate LIQUID ORAL 20160407 OTC MONOGRAPH FINAL part341 THE KROGER CO PYRILAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE 50; 25 mg/30mL; mg/30mL N 20181231 30142-774_35f8ebb7-3e0f-6688-e054-00144ff88e88 30142-774 HUMAN OTC DRUG Kroger Sinus Pain and Pressure Choline Salicylate, Guaifenesin, Phenylephrine LIQUID ORAL 20160407 OTC MONOGRAPH FINAL part341 THE KROGER CO GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; CHOLINE SALICYLATE 200; 10; 870 mg/30mL; mg/30mL; mg/30mL N 20181231 30142-778_f6cfe07a-10f1-4e76-a785-44bb3248ba26 30142-778 HUMAN OTC DRUG Stool Softener Laxative DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20171031 OTC MONOGRAPH NOT FINAL part334 The Kroger Co. DOCUSATE SODIUM 100 mg/1 N 20181231 30142-791_4c466a8c-46fc-0a92-e054-00144ff88e88 30142-791 HUMAN OTC DRUG KROGER MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOE witch hazel cloth SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part346 The Kroger Co. WITCH HAZEL .5 g/g N 20181231 30142-798_7f4ce33d-3d70-47ef-bb87-a3f53057fe71 30142-798 HUMAN OTC DRUG Hair Regrowth Treatment Extra Strength for Men Minoxidil SOLUTION TOPICAL 20091205 ANDA ANDA075598 Kroger Company MINOXIDIL 3 g/60mL N 20181231 30142-799_ab33939e-0df3-4d8d-83c4-2ff32253ea74 30142-799 HUMAN OTC DRUG Tussin DM Max non drowsy Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20100804 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 30142-800_514d19c6-c1c5-463c-8583-8fa434325282 30142-800 HUMAN OTC DRUG acetaminophen pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20140805 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 30142-801_df579366-c16d-4ced-b719-98fac5245ee0 30142-801 HUMAN OTC DRUG ANTIBACTERIAL BODY WASH TRICLOSAN LIQUID TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY TRICLOSAN .15 mL/100mL N 20181231 30142-802_0a26c4b7-302a-4cc7-a7a2-2d7ce18811bd 30142-802 HUMAN OTC DRUG K CARE OCEAN MIST BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 30142-803_0bdd5848-8270-4b68-85e6-dcbc938757c7 30142-803 HUMAN OTC DRUG Winter Apple Hand Sanitizer GEL TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Kroger, CO., ALCOHOL 62 mg/mL N 20181231 30142-804_be52513b-90a0-474f-8b7a-fe7ef1b9a276 30142-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A The Kroger Co ISOPROPYL ALCOHOL .91 mg/mL N 20181231 30142-807_4cf180e9-57c5-47a5-b4f3-0110ee2b9619 30142-807 HUMAN OTC DRUG Cold Remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20090805 UNAPPROVED HOMEOPATHIC Kroger Company ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 30142-809_4eca7228-4bfc-4b6c-839e-73b02faa4d54 30142-809 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20100331 OTC MONOGRAPH NOT FINAL part333 The Kroger Company ISOPROPYL ALCOHOL 70 mL/1 N 20181231 30142-809_b2da8a62-6efa-4a35-9388-d861b9732d56 30142-809 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20100331 OTC MONOGRAPH NOT FINAL part333A The Kroger Company ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 30142-810_1761c9f5-d6d5-43bf-b600-a2f0eea50a50 30142-810 HUMAN OTC DRUG 70% Isopropyl Rubbing Alcohol Isopropyl Rubbing Alcohol SOLUTION TOPICAL 20150828 OTC MONOGRAPH NOT FINAL part333A Kroger CO ISOPROPYL ALCOHOL .7 mg/mL N 20181231 30142-811_a558faec-784f-4287-9673-f32ea9a65eff 30142-811 HUMAN OTC DRUG Daytime Fast Severe Cold Relief Nitetime Fast Cold and Flu Relief Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, doxylamine succinate KIT 20170622 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-816_b3ea5c6d-a21c-429c-8295-7efa4d870b49 30142-816 HUMAN OTC DRUG Dandruff Selenium sulfide SHAMPOO TOPICAL 20130601 OTC MONOGRAPH FINAL part358H Kroger SELENIUM SULFIDE 10 mg/mL N 20181231 30142-817_55faa282-2b8d-4185-9e3c-8929ec3647a8 30142-817 HUMAN OTC DRUG Nasal oxymetazoline hydrochloride SPRAY NASAL 20010924 OTC MONOGRAPH FINAL part341 Kroger Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 30142-818_bf878fa2-207e-46a8-bb5a-21c422b6e080 30142-818 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140212 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 160 mg/5mL N 20181231 30142-822_cf64c807-440b-4e1d-b91b-c68d757cac97 30142-822 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 19890715 OTC MONOGRAPH FINAL part346 Kroger Co WITCH HAZEL 979 mg/mL N 20181231 30142-823_f225eff5-42ee-466e-bee9-64ea2a963213 30142-823 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride OINTMENT TOPICAL 20080724 20180831 OTC MONOGRAPH FINAL part333B Kroger Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 30142-825_d4dd1bc9-f8cc-42ca-a0d1-a0dc25deee86 30142-825 HUMAN OTC DRUG Miconazole 7 Miconazole nitrate CREAM VAGINAL 20020715 ANDA ANDA074760 Kroger Company MICONAZOLE NITRATE 2 g/100g N 20181231 30142-826_05fda364-92eb-426c-8e45-bf9444f22bf0 30142-826 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20140909 OTC MONOGRAPH NOT FINAL part333A The Kroger Co., BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 30142-827_2eb1fff5-fe69-4446-9bdf-dd798eb949e4 30142-827 HUMAN OTC DRUG Laxative Gentle Bisacodyl TABLET, COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Kroger Company BISACODYL 5 mg/1 N 20181231 30142-831_4400ff6d-6187-4acb-a191-207db4d38a9b 30142-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part334 Kroger Co MINERAL OIL 999 mg/mL N 20181231 30142-837_bc0108c5-533a-4396-ba61-aa35afd2636d 30142-837 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 19971015 OTC MONOGRAPH FINAL part338 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 30142-839_50598142-7ca5-42b4-80a8-584933ce82f0 30142-839 HUMAN OTC DRUG Childrens Mucus Relief dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20140517 OTC MONOGRAPH FINAL part341 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 30142-845_32c56ef8-d426-458a-89f2-f8b9205b6fe2 30142-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19890715 OTC MONOGRAPH FINAL part344 Kroger Co ISOPROPYL ALCOHOL 613 mg/mL N 20181231 30142-851_7568ee28-7f7d-434e-85ed-03131ca6c5f8 30142-851 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20021210 OTC MONOGRAPH FINAL part332 Kroger Company ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 30142-852_bf2d703a-2cb6-47c3-8f97-bf593d5d1bc9 30142-852 HUMAN OTC DRUG Heartburn Relief Ranitidine TABLET, FILM COATED ORAL 20130831 ANDA ANDA091429 Kroger Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 30142-854_b19e410d-90ba-4dd6-93a5-f989aa43b388 30142-854 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20070915 ANDA ANDA078546 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-861_a3851fd7-4e4f-4851-95f3-89150da995d3 30142-861 HUMAN OTC DRUG Nicotine nicotine polacrilex LOZENGE ORAL 20110811 NDA NDA021330 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-862_a3851fd7-4e4f-4851-95f3-89150da995d3 30142-862 HUMAN OTC DRUG Nicotine nicotine polacrilex LOZENGE ORAL 20110811 NDA NDA021330 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-863_a3851fd7-4e4f-4851-95f3-89150da995d3 30142-863 HUMAN OTC DRUG Nicotine nicotine polacrilex LOZENGE ORAL 20110811 NDA NDA021330 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-864_a3851fd7-4e4f-4851-95f3-89150da995d3 30142-864 HUMAN OTC DRUG Nicotine nicotine polacrilex LOZENGE ORAL 20110811 NDA NDA021330 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-866_ec5cdcd1-ad0c-4be3-8c2e-0eb17f9ff2e9 30142-866 HUMAN OTC DRUG lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070713 OTC MONOGRAPH FINAL part358G Kroger Company PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 30142-871_5064cd5c-aadd-4e32-986b-8feefbe2e88a 30142-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20170709 OTC MONOGRAPH NOT FINAL part333A Kroger Co. HYDROGEN PEROXIDE 30 mg/mL N 20181231 30142-872_0946dc1d-c7db-472b-b910-e383d4ed1b68 30142-872 HUMAN OTC DRUG nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 19900215 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 30142-873_d4ad136f-1bd1-49a0-870d-42cce7de7532 30142-873 HUMAN OTC DRUG Nicotine Nicotine polacrilex LOZENGE ORAL 20070427 ANDA ANDA077007 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-880_54c76d68-a317-47da-814b-401d8557cfdf 30142-880 HUMAN OTC DRUG Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate SOLUTION ORAL 20140227 OTC MONOGRAPH FINAL part341 Kroger Company PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 30142-882_31fdf8b5-cc51-40c6-81a7-8f0fae9df557 30142-882 HUMAN OTC DRUG gas relief infants Simethicone EMULSION ORAL 19990304 OTC MONOGRAPH FINAL part332 Kroger Company DIMETHICONE 20 mg/.3mL N 20181231 30142-884_4ad93de0-4ec9-4078-8fe0-da54a14eec47 30142-884 HUMAN OTC DRUG All Day Allergy cetirizine Hydrochloride SOLUTION ORAL 20110805 ANDA ANDA090254 Kroger Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 30142-886_8b1ca232-f84f-4d8f-9751-b103aa9337fb 30142-886 HUMAN OTC DRUG sinus Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20070908 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-886_8ba430ba-fcb0-4a6e-a431-a485a95f3189 30142-886 HUMAN OTC DRUG sinus congestion and pain daytime night time Acetaminophen,Phenylephrine HCl, Chlorpheniramine maleate KIT 20110416 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-888_e6f0d48c-c3d7-421c-8395-13c6e3fa2ecc 30142-888 HUMAN OTC DRUG Fast Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140728 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 30142-890_a83e7265-9f64-4eb5-ae8c-85fd9f4e703b 30142-890 HUMAN OTC DRUG Cold and Allergy PE Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20110202 OTC MONOGRAPH FINAL part341 The Kroger Co. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 30142-891_7027fdb0-3ad8-44d6-a409-0f0daf4d2451 30142-891 HUMAN OTC DRUG heartburn relief 150 Ranitidine TABLET, FILM COATED ORAL 20150512 ANDA ANDA091429 Kroger Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 30142-892_b85f1f36-9353-473e-8bb0-9a4406341d3f 30142-892 HUMAN OTC DRUG Medicated Pain Relief Patch CAMPHOR, MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20171012 OTC MONOGRAPH NOT FINAL part348 Kroger Company CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 6; 10 g/100g; g/100g; g/100g N 20181231 30142-897_286495bc-34af-4496-8dd2-f8d1d02a8670 30142-897 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990119 ANDA ANDA074937 Kroger Company IBUPROFEN 100 mg/5mL N 20181231 30142-898_6086a12a-7b39-4ce2-86bf-a4390714e0be 30142-898 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160308 OTC MONOGRAPH NOT FINAL part333A The Kroger Co ALCOHOL 567 mg/mL N 20181231 30142-900_948785e9-ff77-4008-abee-7797200390b8 30142-900 HUMAN OTC DRUG Kroger Burn Relief Aloe LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part348 THE KROGER CO LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 30142-901_756a8156-c4d5-4a74-9a1a-2dec6c24634f 30142-901 HUMAN OTC DRUG Kroger Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-902_065976f1-db9d-4851-916a-d6cb74a73d71 30142-902 HUMAN OTC DRUG Kroger Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-904_503d3e83-23dc-4c22-b7cc-695d806d5c72 30142-904 HUMAN OTC DRUG Kroger Dark Tanning Oil SPF 4 OCTINOXATE SPRAY TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO OCTINOXATE 3 g/100g N 20181231 30142-905_e204f640-e55d-42e3-8ba7-5c07b3f9961d 30142-905 HUMAN OTC DRUG Kroger Aloe Vera Pain Relieving LIDOCAINE MENTHOL LOTION TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part348 THE KROGER CO LIDOCAINE; MENTHOL .7; .2 g/100g; g/100g N 20181231 30142-906_259807d0-e992-4541-a0bd-8192c65f4b14 30142-906 HUMAN OTC DRUG Kroger Aloe Vera Pain Relieving LIDOCAINE MENTHOL GEL TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part348 THE KROGER CO LIDOCAINE; MENTHOL .7; .2 g/100g; g/100g N 20181231 30142-907_c6fbaa47-a89e-4501-b286-3cac64761f89 30142-907 HUMAN OTC DRUG Kroger Baby SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-909_aaf8045d-412d-4684-89a7-e724632ae5f8 30142-909 HUMAN OTC DRUG Kroger SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130906 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-910_0a6992df-4d0d-43bc-b2d1-03d9241163a1 30142-910 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110804 NDA NDA018612 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-911_0a6992df-4d0d-43bc-b2d1-03d9241163a1 30142-911 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110804 NDA NDA020066 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-912_0a6992df-4d0d-43bc-b2d1-03d9241163a1 30142-912 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110804 NDA NDA018612 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-913_0a6992df-4d0d-43bc-b2d1-03d9241163a1 30142-913 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110804 NDA NDA020066 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-914_0a6992df-4d0d-43bc-b2d1-03d9241163a1 30142-914 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110804 NDA NDA018612 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-915_0a6992df-4d0d-43bc-b2d1-03d9241163a1 30142-915 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110804 NDA NDA020066 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-916_0a6992df-4d0d-43bc-b2d1-03d9241163a1 30142-916 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110726 NDA NDA018612 Kroger Company NICOTINE 2 mg/1 N 20181231 30142-918_0a6992df-4d0d-43bc-b2d1-03d9241163a1 30142-918 HUMAN OTC DRUG Nicotine polacrilex nicotine polacrilex GUM, CHEWING ORAL 20110817 NDA NDA020066 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-919_651fbd81-8a76-4e15-818f-e56b29d12821 30142-919 HUMAN OTC DRUG Kroger Sport sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-920_1089fee5-a882-4980-ba4a-27197a15d66f 30142-920 HUMAN OTC DRUG Kroger Kroger Kids Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE SPRAY TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-921_b824a52d-99b7-44b0-924c-b33c6e6f82c5 30142-921 HUMAN OTC DRUG Kroger Oil Free Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-922_9a8743f0-ad25-4ff5-a470-d70255d8a07f 30142-922 HUMAN OTC DRUG Kroger Sheer Dry Touch Sunscreen SPF 55 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-924_534e0dac-6c5f-4288-b286-eb2be49b805f 30142-924 HUMAN OTC DRUG Kroger Sheer Dry Touch Sunscreen SPF 70 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-925_dd4e11af-dd4a-4a4d-88ec-fcfc24496be5 30142-925 HUMAN OTC DRUG Kroger Sunscreen SPF 8 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g N 20181231 30142-926_b67e5473-7075-4d17-bb50-ea4ffeb1c23c 30142-926 HUMAN OTC DRUG Daytime NiteTime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20060828 OTC MONOGRAPH FINAL part341 Kroger Company N 20181231 30142-927_129b8e0d-0e49-4151-99a5-d2faf580b24a 30142-927 HUMAN OTC DRUG Kroger Kids Sunscreen SPF 70 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-928_ff16d7e2-816c-47e1-8d05-fd5c6f721813 30142-928 HUMAN OTC DRUG Kroger Baby Sunscreen SPF 70 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-929_74ce61f3-b066-41bb-94fa-c2a1aa792a96 30142-929 HUMAN OTC DRUG KROGER SPF 4 TANNING OIL OCTINOXATE, PADIMATE O SPRAY TOPICAL 20130814 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO OCTINOXATE; PADIMATE O 2; 1.4 g/100g; g/100g N 20181231 30142-930_559abce4-cedf-4385-975e-82e6b3bcceba 30142-930 HUMAN OTC DRUG Kroger Lip Treatment Petrolatum GEL TOPICAL 20130502 OTC MONOGRAPH FINAL part347 Kroger PETROLATUM 99.98 mg/g N 20181231 30142-931_897c8709-e798-4bfd-80f0-1b8831682c13 30142-931 HUMAN OTC DRUG Kroger Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kroger OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g N 20181231 30142-932_ca9df950-d581-4bad-9431-aff5f00bdc98 30142-932 HUMAN OTC DRUG Kroger Kids SPF 50 Sunstick Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20130429 OTC MONOGRAPH NOT FINAL part352 Kroger AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 7.5; 5; 10; 4 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 30142-933_307b1b1c-8277-4883-9ff3-d77d9f67b1f7 30142-933 HUMAN OTC DRUG Kroger Sport SPF 50 Sunstick Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20130429 OTC MONOGRAPH NOT FINAL part352 Kroger AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 7.5; 5; 10; 4 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 30142-936_0df5a49f-b1e9-4d7b-b7f4-4972ec1f44b4 30142-936 HUMAN OTC DRUG Kroger Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20140623 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-937_d2737fad-aaab-44de-a704-919442e19692 30142-937 HUMAN OTC DRUG Kroger Sport Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20140627 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-938_8069eb88-814e-4e03-8ee4-dd94261f18d0 30142-938 HUMAN OTC DRUG Kroger Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20140627 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 30142-939_1df04f44-e9ce-4be8-b639-8568c319acbc 30142-939 HUMAN OTC DRUG KROGER SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140623 OTC MONOGRAPH NOT FINAL part352 THE KROGER CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 30142-941_a3df172d-b802-4389-a85b-67dd9daa2e43 30142-941 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160308 OTC MONOGRAPH NOT FINAL part333A The Kroger Co ALCOHOL 567 mg/mL N 20181231 30142-942_3e7adeea-018b-4925-a673-7dbc10f3e0dd 30142-942 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160308 OTC MONOGRAPH NOT FINAL part333A The Kroger Co ALCOHOL 567 mg/mL N 20181231 30142-944_8596c3c6-077c-4db9-9e17-5f59c759db02 30142-944 HUMAN OTC DRUG hemorrhoidal maximum strength pain relief glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20091007 OTC MONOGRAPH FINAL part346 Kroger Company GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 30142-950_7f94f002-5b13-4d7c-a94d-249814e18692 30142-950 HUMAN OTC DRUG heartburn relief Ranitidine TABLET, FILM COATED ORAL 20110920 ANDA ANDA091429 Kroger Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 30142-951_81ae4d39-e8fc-4c29-b003-1a61cd177772 30142-951 HUMAN OTC DRUG Waterless Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20110228 OTC MONOGRAPH NOT FINAL part333A Kroger Co ALCOHOL 65 kg/100L N 20181231 30142-952_c93613cf-f330-40a3-a0b9-cacbdf84749f 30142-952 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140618 OTC MONOGRAPH NOT FINAL part333A The Kroger Co BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 30142-957_a9d864ac-7c46-4c51-b4d5-74c37ce7f444 30142-957 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130511 ANDA ANDA203690 Kroger Company NICOTINE 4 mg/1 N 20181231 30142-958_8610d995-61ea-4c16-93e9-bd4bfed4e2d1 30142-958 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130815 ANDA ANDA091135 Kroger Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 30142-964_4f12e808-3693-49fb-bab7-c0f91b324184 30142-964 HUMAN OTC DRUG flu and severe cold and cough nite time Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100902 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 30142-966_b9b6d59f-f2b6-4c80-99f0-b3cb48733338 30142-966 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080311 ANDA ANDA075077 Kroger Company ACETAMINOPHEN 650 mg/1 N 20181231 30142-973_68dab606-0385-48b7-9a7b-a2cf83d20393 30142-973 HUMAN OTC DRUG hydrocortisone hydrocortisone CREAM TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part348 Kroger Company HYDROCORTISONE 1 g/100g N 20181231 30142-974_34121dc6-6abb-4a19-b8db-684f8137c5ee 30142-974 HUMAN OTC DRUG all day allergy cetirizine hydrochloride LIQUID ORAL 20080508 ANDA ANDA090254 Kroger Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 30142-975_db1d979b-106b-44fb-8950-2376750e21d6 30142-975 HUMAN OTC DRUG acetaminophen Acetaminophen TABLET ORAL 20140405 OTC MONOGRAPH NOT FINAL part343 Kroger Company ACETAMINOPHEN 500 mg/1 N 20181231 30142-976_f2716fef-d594-43a7-9c82-0c4ba37a7641 30142-976 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160308 OTC MONOGRAPH NOT FINAL part333A The Kroger Co ALCOHOL 567 mg/mL N 20181231 30142-977_76d22e74-5016-40bf-974f-62060157d37a 30142-977 HUMAN OTC DRUG Nite Time multi symptom cold/flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20060509 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 30142-982_74818a54-25a0-45f3-bd8f-192fa35bc0f2 30142-982 HUMAN OTC DRUG miconazole 3 Miconazole nitrate KIT 20040817 ANDA ANDA076357 Kroger Company N 20181231 30142-987_23c1ddea-19cc-468b-8882-bada028c1590 30142-987 HUMAN OTC DRUG Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20070821 OTC MONOGRAPH FINAL part341 Kroger Company BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 30142-993_f5d82d1b-2f75-4af4-8337-a5bd28c26fb7 30142-993 HUMAN OTC DRUG Ultra Strength Antacid Antacid Tablets TABLET, CHEWABLE ORAL 20180105 OTC MONOGRAPH FINAL part331 THE KROGER CO., CALCIUM CARBONATE 1000 mg/1 N 20181231 30142-997_e93499ef-fb7b-4fce-9b66-30bd985ce2e1 30142-997 HUMAN OTC DRUG Sinus Relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20150408 OTC MONOGRAPH FINAL part341 Kroger Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 30142-998_4cbac3c7-3488-451f-baa2-4471c4f76f7c 30142-998 HUMAN OTC DRUG Anti Diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030221 ANDA ANDA075232 Kroger Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 30142-999_e2d22c18-a32a-4bf6-8ee2-78ae3e41ba96 30142-999 HUMAN OTC DRUG Zinc Cold therapy ZINC GLUCONATE TABLET ORAL 20180112 UNAPPROVED HOMEOPATHIC THE KROGER CO., ZINC GLUCONATE 1 [hp_X]/1 N 20181231 30237-8900_c6b38914-e7be-4879-ae4b-db46def55dd4 30237-8900 CELLULAR THERAPY PROVENGE sipuleucel-T INJECTION INTRAVENOUS 20100429 BLA BLA125197 Dendreon Pharmaceuticals LLC SIPULEUCEL-T 50000000 1/1 Autologous Cellular Immunotherapy [EPC],Cell-mediated Immunity [PE],Cells, Cultured, Autologous [Chemical/Ingredient],Peripheral Blood Mononuclear Cells [Chemical/Ingredient] N 20181231 30400-211_7b158cdf-4e11-49b0-bb85-07d6b32de6e5 30400-211 HUMAN OTC DRUG PETROLATUM PETROLATUM JELLY TOPICAL 20140424 OTC MONOGRAPH FINAL part347 Jell Pharmaceuticals Pvt. Ltd. PETROLATUM 1 g/g N 20181231 30400-214_f294a17d-be59-4373-a5ae-109967412358 30400-214 HUMAN OTC DRUG Jell Pharmaceuticals Vitamin A D Petrolatum OINTMENT TOPICAL 20140424 OTC MONOGRAPH FINAL part347 Jell Pharmaceuticals Pvt. Ltd. PETROLATUM .76 g/g N 20181231 30493-001_56ba8688-6b60-5719-e054-00144ff88e88 30493-001 HUMAN OTC DRUG Wet Ones Fresh Scent Benzalkonium chloride CLOTH TOPICAL 20170811 OTC MONOGRAPH NOT FINAL part333A FOSHAN CITY SHUNDE AREA SOSHIO WET TISSUE CO., LTD. BENZALKONIUM CHLORIDE .09 g/1 N 20181231 30698-007_18eb4839-90f7-406d-bd8c-efcef831f228 30698-007 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 Validus Pharmaceuticals LLC DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 30698-011_18eb4839-90f7-406d-bd8c-efcef831f228 30698-011 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 Validus Pharmaceuticals LLC DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 30698-015_18eb4839-90f7-406d-bd8c-efcef831f228 30698-015 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 Validus Pharmaceuticals LLC DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 30698-019_18eb4839-90f7-406d-bd8c-efcef831f228 30698-019 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 Validus Pharmaceuticals LLC DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 30698-020_18eb4839-90f7-406d-bd8c-efcef831f228 30698-020 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 Validus Pharmaceuticals LLC DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 30698-021_18eb4839-90f7-406d-bd8c-efcef831f228 30698-021 HUMAN PRESCRIPTION DRUG Norpramin desipramine hydrochloride TABLET, SUGAR COATED ORAL 19641120 NDA NDA014399 Validus Pharmaceuticals LLC DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] E 20171231 30698-032_756df327-b9e9-4436-bd97-9687e79fddd2 30698-032 HUMAN PRESCRIPTION DRUG Marplan isocarboxazid TABLET ORAL 19590701 NDA NDA011961 Validus Pharmaceuticals LLC ISOCARBOXAZID 10 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 30698-060_82414c57-bd5a-41b4-965d-873397b2a7a6 30698-060 HUMAN PRESCRIPTION DRUG Lasix FUROSEMIDE TABLET ORAL 19660701 NDA NDA016273 Validus Pharmaceuticals LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 30698-066_82414c57-bd5a-41b4-965d-873397b2a7a6 30698-066 HUMAN PRESCRIPTION DRUG Lasix FUROSEMIDE TABLET ORAL 19780424 NDA NDA016273 Validus Pharmaceuticals LLC FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 30698-067_82414c57-bd5a-41b4-965d-873397b2a7a6 30698-067 HUMAN PRESCRIPTION DRUG Lasix FUROSEMIDE TABLET ORAL 19740507 NDA NDA016273 Validus Pharmaceuticals LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 30698-120_290c93ea-741e-4fe8-bf2a-7da24ee1aa87 30698-120 HUMAN PRESCRIPTION DRUG ANZEMET dolasetron mesylate TABLET, FILM COATED ORAL 19970911 NDA NDA020623 Validus Pharmaceuticals LLC DOLASETRON MESYLATE 50 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 30698-121_290c93ea-741e-4fe8-bf2a-7da24ee1aa87 30698-121 HUMAN PRESCRIPTION DRUG ANZEMET dolasetron mesylate TABLET, FILM COATED ORAL 19970911 NDA NDA020623 Validus Pharmaceuticals LLC DOLASETRON MESYLATE 100 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 30698-143_989e933e-3757-4b1f-97af-22f99487e23f 30698-143 HUMAN PRESCRIPTION DRUG Rocaltrol calcitriol CAPSULE, GELATIN COATED ORAL 20090810 NDA NDA018044 Validus Pharmaceuticals LLC CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 30698-144_989e933e-3757-4b1f-97af-22f99487e23f 30698-144 HUMAN PRESCRIPTION DRUG Rocaltrol calcitriol CAPSULE, GELATIN COATED ORAL 20090810 NDA NDA018044 Validus Pharmaceuticals LLC CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 30698-201_4551302c-da8e-4a13-8afa-eb3dafa49be3 30698-201 HUMAN PRESCRIPTION DRUG Parlodel bromocriptine mesylate CAPSULE, GELATIN COATED ORAL 20140428 NDA NDA017962 Validus Pharmaceuticals LLC BROMOCRIPTINE MESYLATE 5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 30698-202_4551302c-da8e-4a13-8afa-eb3dafa49be3 30698-202 HUMAN PRESCRIPTION DRUG Parlodel bromocriptine mesylate TABLET ORAL 20140620 NDA NDA017962 Validus Pharmaceuticals LLC BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 30698-277_413d14b7-d2d6-43cb-a318-76fc0bf8966b 30698-277 HUMAN PRESCRIPTION DRUG HIPREX Methenamine Hippurate TABLET ORAL 19760909 NDA NDA017681 Validus Pharmaceuticals LLC METHENAMINE HIPPURATE 1 g/1 N 20181231 30698-335_12143844-4f57-460b-a405-71051b127e97 30698-335 HUMAN PRESCRIPTION DRUG Demerol Meperidine Hydrochloride TABLET ORAL 19421110 NDA NDA005010 Validus Pharmaceuticals LLC MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 30698-337_12143844-4f57-460b-a405-71051b127e97 30698-337 HUMAN PRESCRIPTION DRUG Demerol Meperidine Hydrochloride TABLET ORAL 19421110 NDA NDA005010 Validus Pharmaceuticals LLC MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 30698-393_4a0b7bf2-cbfc-4da1-9785-d4dd3f0bd807 30698-393 HUMAN PRESCRIPTION DRUG DRISDOL ergocalciferol CAPSULE, LIQUID FILLED ORAL 19740111 NDA NDA003444 Validus Pharmaceuticals LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 30698-419_75b02a2b-0a01-4f27-b7a7-8ec605a677ce 30698-419 HUMAN PRESCRIPTION DRUG EQUETRO Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20041210 NDA NDA021710 Validus Pharmaceuticals LLC CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 30698-421_75b02a2b-0a01-4f27-b7a7-8ec605a677ce 30698-421 HUMAN PRESCRIPTION DRUG EQUETRO Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20041210 NDA NDA021710 Validus Pharmaceuticals LLC CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 30698-423_75b02a2b-0a01-4f27-b7a7-8ec605a677ce 30698-423 HUMAN PRESCRIPTION DRUG EQUETRO Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20041210 NDA NDA021710 Validus Pharmaceuticals LLC CARBAMAZEPINE 300 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 30698-448_6d26b632-1749-45e7-99da-2bb5e1db20d7 30698-448 HUMAN PRESCRIPTION DRUG Lotensin benazepril hydrochloride TABLET ORAL 19910621 NDA NDA019851 Validus Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 30698-449_6d26b632-1749-45e7-99da-2bb5e1db20d7 30698-449 HUMAN PRESCRIPTION DRUG Lotensin benazepril hydrochloride TABLET ORAL 19910621 NDA NDA019851 Validus Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 30698-450_6d26b632-1749-45e7-99da-2bb5e1db20d7 30698-450 HUMAN PRESCRIPTION DRUG Lotensin benazepril hydrochloride TABLET ORAL 19910621 NDA NDA019851 Validus Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 30698-452_294af145-7f9b-4872-b2a4-84fa49494b35 30698-452 HUMAN PRESCRIPTION DRUG Lotensin HCT benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 19920530 NDA NDA020033 Validus Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 30698-453_294af145-7f9b-4872-b2a4-84fa49494b35 30698-453 HUMAN PRESCRIPTION DRUG Lotensin HCT benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 19920530 NDA NDA020033 Validus Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 30698-454_294af145-7f9b-4872-b2a4-84fa49494b35 30698-454 HUMAN PRESCRIPTION DRUG Lotensin HCT benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 19920530 NDA NDA020033 Validus Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 30698-458_6401e230-5a12-4a98-b788-08e9cacb1cb8 30698-458 HUMAN PRESCRIPTION DRUG Lopressor metoprolol tartrate TABLET ORAL 20140505 NDA NDA017963 Validus Pharmaceuticals LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 30698-459_6401e230-5a12-4a98-b788-08e9cacb1cb8 30698-459 HUMAN PRESCRIPTION DRUG Lopressor metoprolol tartrate TABLET ORAL 20140505 NDA NDA017963 Validus Pharmaceuticals LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 30698-460_d8964894-3cd8-41c1-a844-148d2ef38a88 30698-460 HUMAN PRESCRIPTION DRUG Lopressor HCT metoprolol tartrate and hydrochlorothiazide TABLET ORAL 19841231 NDA NDA018303 Validus Pharmaceuticals LLC METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 30698-911_989e933e-3757-4b1f-97af-22f99487e23f 30698-911 HUMAN PRESCRIPTION DRUG Rocaltrol calcitriol SOLUTION ORAL 20090723 NDA NDA021068 Validus Pharmaceuticals LLC CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 30727-300_5e5ca26f-55f8-7e2d-e053-2a91aa0a65c4 30727-300 HUMAN PRESCRIPTION DRUG B-PLEX 100 Thiamine Hydrochloride, Riboflavin 5-Phosphate Sodium, Pyridoxine Hydrochloride, Dexpanthenol, Niacinamide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120101 UNAPPROVED DRUG OTHER Merit Pharmaceutical THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; NIACINAMIDE 100; 2; 2; 2; 100 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 30727-304_14d3177b-f249-4372-9a7b-c9353a85b57a 30727-304 HUMAN PRESCRIPTION DRUG Chloromag Magnesium Chloride INJECTION, SOLUTION INTRAVENOUS 20110611 UNAPPROVED DRUG OTHER Merit Pharmaceutical MAGNESIUM CHLORIDE 200 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 30727-339_5e5ca26f-5605-7e2d-e053-2a91aa0a65c4 30727-339 HUMAN PRESCRIPTION DRUG MEGA-C-ACID PLUS Ascorbic Acid INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100101 UNAPPROVED DRUG OTHER Merit Pharmaceutical ASCORBIC ACID 500 mg/mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20181231 30727-810_5e6d5bf8-8066-06b2-e053-2a91aa0a99bf 30727-810 HUMAN OTC DRUG Mericaine Lidocaine GEL TOPICAL 20150701 UNAPPROVED DRUG OTHER Merit Pharmaceutical LIDOCAINE .04 g/g N 20181231 30803-001_8c7953ed-0a84-48c8-92a7-bfea6d064c55 30803-001 HUMAN OTC DRUG MAYINGLONG BEZORNIL HEMORRHOIDAL CALAMINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE OINTMENT RECTAL; TOPICAL 20130828 OTC MONOGRAPH FINAL part346 MAYINGLONG PHARMACEUTICAL GROUP CO LTD ZINC OXIDE; FERRIC OXIDE RED; PHENYLEPHRINE HYDROCHLORIDE; PETROLATUM 10.4; .05; .25; 79.25 g/100g; g/100g; g/100g; g/100g N 20181231 30805-001_1aee8ffe-6d3c-40c0-a1a5-e7572d4993d6 30805-001 HUMAN OTC DRUG Symmetry Hand Sanitizer Alcohol LIQUID TOPICAL 20071116 OTC MONOGRAPH NOT FINAL part333A Buckeye International, Inc. ALCOHOL 62 mL/100mL N 20181231 30805-003_38b297be-e41f-46ed-9c5f-b534a393f9a5 30805-003 HUMAN OTC DRUG Symmetry Foaming Hand Sanitizer Alcohol LIQUID TOPICAL 20071116 OTC MONOGRAPH NOT FINAL part333A Buckeye International, Inc. ALCOHOL 62 mL/100mL N 20181231 30805-006_50eebc94-9e59-44a2-bfcc-85c5652df7bd 30805-006 HUMAN OTC DRUG Symmetry Antimicrobial Foaming Hand Wash Chloroxylenol LIQUID TOPICAL 20071116 OTC MONOGRAPH NOT FINAL part333A Buckeye International, Inc. CHLOROXYLENOL .3 mL/100mL N 20181231 30805-007_586c3d60-6616-47d7-b143-fe592b78feda 30805-007 HUMAN OTC DRUG Symmetry Non-Alcohol Foaming Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20090609 OTC MONOGRAPH NOT FINAL part333A Buckeye International, Inc. BENZALKONIUM CHLORIDE .24 mL/100mL N 20181231 30805-008_c487349e-ced3-4afd-a24b-7340cc50190f 30805-008 HUMAN OTC DRUG Symmetry Foaming Hand Sanitizer-Unscented Ethyl Alcohol LIQUID TOPICAL 20100712 OTC MONOGRAPH NOT FINAL part333 Buckeye International, Inc. ALCOHOL 62 mL/100mL E 20171231 30805-009_2d078cf9-4e77-4b85-9c2e-14c6b290547f 30805-009 HUMAN OTC DRUG Symmetry Foaming Hand Sanitizer-Fragrance Free with Aloe and Vitamin E Alcohol LIQUID TOPICAL 20111004 OTC MONOGRAPH NOT FINAL part333A Buckeye International, Inc. ALCOHOL 62 mL/100mL N 20181231 30805-010_39935c6b-8456-4166-ba1e-b18b4a79383c 30805-010 HUMAN OTC DRUG Symmetry Non-Alcohol Foaming Hand Sanitizer with Allantoin and Aloe Benzalkonium Chloride SOLUTION TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part333A Buckeye International, Inc. BENZALKONIUM CHLORIDE .12 g/100mL N 20181231 30805-011_8367fb3c-3c54-4cf6-8cda-1c6154cf1d01 30805-011 HUMAN OTC DRUG Symmetry Foaming Hand Sanitizer Alcohol AEROSOL, FOAM TOPICAL 20171214 OTC MONOGRAPH NOT FINAL part333E Buckeye International, Inc. ALCOHOL 62 g/100g N 20181231 30807-2002_da7e8ff8-602e-4287-80a2-b3c155a17bfa 30807-2002 HUMAN OTC DRUG Quit Nits Advance quassia amara CREAM TOPICAL 20080101 UNAPPROVED HOMEOPATHIC Wild Child W A Pty Ltd QUASSIA 2 [HP_X]/60mL E 20171231 30807-3003_d5e22b60-37f8-48e6-88bb-e3eea3efecfd 30807-3003 HUMAN OTC DRUG Quit Nits Preventative eucalyptus globulus SPRAY TOPICAL 20080101 UNAPPROVED HOMEOPATHIC Wild Child W A Pty Ltd EUCALYPTUS GLOBULUS LEAF 1 [HP_X]/125mL E 20171231 30815-0040_a96f4f4a-17d5-48a0-bed5-ea0a6ee0bce2 30815-0040 HUMAN PRESCRIPTION DRUG Hydro-Q Hydroquinone GEL TOPICAL 20081208 UNAPPROVED DRUG OTHER Dermavance Pharmaceuticals HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 31190-100_635267e1-2830-4bd8-ae57-7ca8017be8fa 31190-100 HUMAN OTC DRUG ALCOHOL FREE HAND SANITIZER BENZALKONIUM CHLORIDE AEROSOL, FOAM TOPICAL 20100407 OTC MONOGRAPH FINAL part333 Shanghai Kejing Cleaning Products Co., Ltd. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 31190-101_6a0e462b-dbca-4b9c-b35f-ea3028ebabea 31190-101 HUMAN OTC DRUG Skin protectant SODIUM BICARBONATE LIQUID TOPICAL 20160118 OTC MONOGRAPH FINAL part347 Shanghai Kejing Cleaning Products Co., Ltd. SODIUM BICARBONATE 5 g/100g E 20171231 31190-200_9be4854e-39ac-45ca-91d6-d01576baa281 31190-200 HUMAN OTC DRUG SunScreen SPF30 HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20100415 OTC MONOGRAPH FINAL part352 Shanghai Kejing Cleaning Products Co., Ltd. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 5; 7.5; 5; 4.25 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 31190-210_35f669b1-277a-4833-9f00-8ee0c885f964 31190-210 HUMAN OTC DRUG Sunscreen SPF 30 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part352 Shanghai Kejing Cleaning Products Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 2.5 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 31190-300_2e6b561b-e522-428e-963b-a8907cc2fe2e 31190-300 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE and VITAMIN E ALCOHOL SPRAY TOPICAL 20100415 OTC MONOGRAPH FINAL part333 Shanghai Kejing Cleaning Products Co., Ltd. ALCOHOL 62 mL/100mL E 20171231 31190-320_6fc072cf-c5bc-434a-bd0d-899925cd489d 31190-320 HUMAN OTC DRUG SPF 30 SUNSCREEN OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part352 Shanghai Kejing Cleaning Products Co., Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 4; 2.5 g/100g; g/100g; g/100g; g/100g E 20171231 31190-330_8d9da62d-8fde-4d72-96d3-2e0cffc6ecee 31190-330 HUMAN OTC DRUG SPF 30 SUNSCREEN OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE SPRAY TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part352 Shanghai Kejing Cleaning Products Co., Ltd. OCTINOXATE; SOYBEAN OIL; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 3; 2; 4; 2.5 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 31190-400_15e9feec-571e-4735-96d6-80dd3da1e101 31190-400 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20100415 OTC MONOGRAPH FINAL part333 Shanghai Kejing Cleaning Products Co., Ltd. ALCOHOL 62 mL/100mL E 20171231 31190-500_672bc701-51b5-4c58-875e-75012e3bbf05 31190-500 HUMAN OTC DRUG SunScreen SPF30 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20100422 OTC MONOGRAPH FINAL part352 Shanghai Kejing Cleaning Products Co., Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 4; 2.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 31190-700_f49b3311-e3b2-4616-b1b7-dd64b69f3e37 31190-700 HUMAN OTC DRUG SunScreen SPF 30 AVOBENZONE,OCTINOXATE, OCTISALATE, OXYBENZONE STICK TOPICAL 20110901 OTC MONOGRAPH FINAL part352 Shanghai Kejing Cleaning Products Co., Ltd. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 6 g/100g; g/100g; g/100g; g/100g E 20171231 31190-800_18f704bc-ac5d-452b-94cc-138246717cac 31190-800 HUMAN OTC DRUG ALCOHOL FREE HAND SANITIZER BENZALKONIUM CHLORIDE GEL TOPICAL 20110902 OTC MONOGRAPH FINAL part333E Shanghai Kejing Cleaning Products Co., Ltd. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 31382-262_31b772b2-a127-43d4-9f60-fe6e7460ae63 31382-262 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088389 CareStream Health, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .02 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 31382-557_de328af3-2345-40cd-a393-ab91adc5c9a8 31382-557 HUMAN PRESCRIPTION DRUG Marcaine bupivacaine hydrochloride and epinephrine bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20130601 ANDA ANDA077250 Carestream Health Inc. BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 5; .005 mg/mL; mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 31382-753_b4904927-4a68-47a4-bddf-fc2fa6d83875 31382-753 HUMAN PRESCRIPTION DRUG Carbocaine Mepivacaine hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088387 Caresteam Health, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 31382-830_92cc5ca7-1aaf-4912-802c-80837ddd6e3f 31382-830 HUMAN PRESCRIPTION DRUG Zorcaine Articaine hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20110901 NDA NDA020971 Carestream Health, Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 31382-898_ac668f6a-b837-4dd7-8f5f-3363f560a6be 31382-898 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 CareStream Health, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 31382-931_b4904927-4a68-47a4-bddf-fc2fa6d83875 31382-931 HUMAN PRESCRIPTION DRUG Carbocaine with Neo-Cobefrin Mepivacaine hydrochloride and Levonordefrin INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088388 Caresteam Health, Inc. MEPIVACAINE HYDROCHLORIDE; LEVONORDEFRIN 20; .05 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 31507-576_876f1175-8107-4af4-b39a-b47d2ce06107 31507-576 HUMAN OTC DRUG Hand Guard Foaming Antimicrobial TRICLOSAN SOAP TOPICAL 20120117 OTC MONOGRAPH NOT FINAL part333E Wechem, Inc. TRICLOSAN 3 mg/mL E 20171231 31507-585_c958573b-3c11-47f6-bb6a-99ce8622516c 31507-585 HUMAN OTC DRUG Hand Guard Foaming Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120117 OTC MONOGRAPH NOT FINAL part333E Wechem, Inc. ALCOHOL .62 mL/mL N 20181231 31507-876_f10903fb-9891-4036-a79b-ab5db95d2e33 31507-876 HUMAN OTC DRUG Hand Guard High Foaming Antiseptic Hand and Body Wash CHLOROXYLENOL SOAP TOPICAL 20170104 OTC MONOGRAPH NOT FINAL part333E Wechem, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 31511-007_118badbd-5285-4ce3-81ba-c3963b7d94dc 31511-007 HUMAN OTC DRUG Nobac Plus AB-F Benzalkonium Chloride LIQUID TOPICAL 20111129 OTC MONOGRAPH NOT FINAL part333A Mason Chemical Company BENZALKONIUM CHLORIDE .13 mL/100mL N 20181231 31511-008_368ab37a-3a4d-4829-a896-ea132227a4cc 31511-008 HUMAN OTC DRUG Nobac Plus Benzalkonium Chloride LIQUID TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333A Mason Chemical Company BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 31511-009_6fdb16b2-454e-4a07-8e6c-801922ed6b51 31511-009 HUMAN OTC DRUG Nobac Plus AB-F E2 Benzalkonium Chloride LIQUID TOPICAL 20120210 OTC MONOGRAPH NOT FINAL part333A Mason Chemical Company BENZALKONIUM CHLORIDE .13 mL/100mL N 20181231 31511-010_c4f211af-2100-47cf-9b47-b01b0fbec216 31511-010 HUMAN OTC DRUG Nobac Plus E3 Benzalkonium Chloride LIQUID TOPICAL 20120210 OTC MONOGRAPH NOT FINAL part333A Mason Chemical Company BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 31586-2683_518cb3cf-987a-425f-8679-7f17b710c175 31586-2683 HUMAN OTC DRUG Celadrin Menthol CREAM TOPICAL 20070430 OTC MONOGRAPH NOT FINAL part348 Natural Factors Nutritional Products Ltd MENTHOL 1.5 g/100g E 20171231 31625-001_22009401-a558-2b63-e054-00144ff88e88 31625-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20151001 UNAPPROVED MEDICAL GAS Lighthouse Medical Equipment LLC OXYGEN 99 L/100L E 20171231 31645-129_64b7910d-31f6-47c4-a46f-1b7a1c110b50 31645-129 HUMAN OTC DRUG Le Velvet Film Makeup Refill SPF 15 Octisalate, Titanium Dioxide PASTE TOPICAL 20000101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc OCTISALATE; TITANIUM DIOXIDE 5; 23 g/100g; g/100g E 20171231 31645-140_6a77f09d-f698-4637-98ee-8417fa5c7f99 31645-140 HUMAN OTC DRUG Solar Powder SPF 20 Titanium Dioxide POWDER TOPICAL 20050101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE 3 g/100g E 20171231 31645-142_47ad31b1-0409-43aa-89c0-b4b87faf46fa 31645-142 HUMAN OTC DRUG Mineral Wear Talc-Free Mineral Face Powder SPF 16 Titanium Dioxide, Zince Oxide POWDER TOPICAL 20070101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 6.2; 4.2 g/100g; g/100g E 20171231 31645-145_244f1c74-afb9-4dbd-e054-00144ff8d46c 31645-145 HUMAN OTC DRUG Organic Wear 100% Natural Origin Tinted Moisturizer SPF 15 TITANIUM DIOXIDE CREAM TOPICAL 20090201 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE 3.95 g/100g E 20171231 31645-147_24ecc498-c2c5-1c20-e054-00144ff8d46c 31645-147 HUMAN OTC DRUG Mineral Wear Talc-Free Mineral Loose Powder SPF 16 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20080101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 12; 4.2 g/100g; g/100g N 20181231 31645-149_24ec8e35-615e-6df2-e054-00144ff8d46c 31645-149 HUMAN OTC DRUG MINERAL WEAR TALC FREE MINERAL TINTED MOISTURIZER SPF 15 TITANIUMDIOXIDE CREAM TOPICAL 20090201 OTC MONOGRAPH FINAL part352 PHYSICIANS FORMULA INC TITANIUM DIOXIDE 3.8 g/100g E 20171231 31645-150_ae8b0ed3-3ab2-4eff-b2e1-b03ea04ea60a 31645-150 HUMAN OTC DRUG Healthy Wear Tinted Moisturizer SPF 50 Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20100301 OTC MONOGRAPH FINAL part352 Physicians Formula Inc. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 8.5; 2.94 g/100g; g/100g; g/100g; g/100g E 20171231 31645-151_253ef818-0c3e-0177-e054-00144ff8d46c 31645-151 HUMAN OTC DRUG Healthy Wear Powder Foundation SPF 50 Octinoxate, Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20100301 OTC MONOGRAPH FINAL part352 Physicians Formula Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 21; 3 g/100g; g/100g; g/100g E 20171231 31645-152_a0b97114-8a98-4009-8ba3-ed0243c52699 31645-152 HUMAN OTC DRUG Healthy Wear Pressed Bronzer SPF 50 Octinoxate, Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20100301 OTC MONOGRAPH FINAL part352 Physicians Formula Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 21; 3 g/100g; g/100g; g/100g E 20171231 31645-153_24ae8477-4b12-6e39-e054-00144ff88e88 31645-153 HUMAN OTC DRUG Mineral Wear Talc-Free Illuminating Powder Duo SPF 16 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20100301 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 12; 4.2 g/100g; g/100g E 20171231 31645-154_24ae5ad5-0091-6ec0-e054-00144ff88e88 31645-154 HUMAN OTC DRUG Mineral Wear Talc-Free Illuminating Powder Duo SPF 16 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20100301 OTC MONOGRAPH FINAL part352 Physicians Formula Inc ZINC OXIDE; TITANIUM DIOXIDE 4.2; 12 g/100g; g/100g N 20181231 31645-155_24ea7673-b96f-0d9b-e054-00144ff8d46c 31645-155 HUMAN OTC DRUG Mineral Wear Talc-Free Airbrushing Loose Powder SPF 30 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20110101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g N 20181231 31645-156_24ea7673-b97a-0d9b-e054-00144ff8d46c 31645-156 HUMAN OTC DRUG Mineral Wear Talc-Free Correcting Primer SPF 15 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20110201 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 2.9; 3 g/100g; g/100g E 20171231 31645-157_253ef818-0c49-0177-e054-00144ff8d46c 31645-157 HUMAN OTC DRUG Wrinkle Corrector and Firming Moisturizer SPF 15 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20110715 OTC MONOGRAPH FINAL part352 Physicians Formula Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 3.75; 2.5; 2.75; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 31645-158_0eef79f2-66f6-45d0-8b98-f47b3a5cca48 31645-158 HUMAN OTC DRUG Hydrating and Balancing Moisturizer SPF 15 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20110715 OTC MONOGRAPH FINAL part352 Physicians Formula Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 3.75; 2.5; 2.75; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 31645-159_60b6bc89-53bd-4678-8ff1-e4019be8a477 31645-159 HUMAN OTC DRUG Mineral Wear Talc Free Airbrushing Pressed Powder SPF 30 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120102 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g N 20181231 31645-160_24c7ac99-bc8c-4c16-e054-00144ff88e88 31645-160 HUMAN OTC DRUG Youthful Wear Cosmeceutical Youth Boosting Foundation SPF 15 Zinc Oxide CREAM TOPICAL 20120101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc ZINC OXIDE 1.96 g/100g E 20171231 31645-161_4f7d0fe6-a1bd-4d2c-93de-eefde64eead2 31645-161 HUMAN OTC DRUG MINERAL WEAR TALC FREE MINERAL AIRBRUSHING BRONZER SPF 30 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH FINAL part352 PHYSICIANS FORMULA INC TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g E 20171231 31645-162_d855a506-2567-42f8-ad22-b2b59538f7c4 31645-162 HUMAN OTC DRUG MINERAL WEAR TALC-FREE MINERAL AIRBRUSHING BLUSH SPF 30 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20121201 OTC MONOGRAPH FINAL part352 PHYSICIANS FORMULA INC TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g E 20171231 31645-163_24aea485-5405-1ad3-e054-00144ff8d46c 31645-163 HUMAN OTC DRUG Super BB 10-in-1 Beauty Balm Concealer SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20130105 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 5.814; 6 g/100g; g/100g E 20171231 31645-164_0b08e5f6-7ced-440c-8d3f-c4c79f498f58 31645-164 HUMAN OTC DRUG SUPER BB 10-IN-1 BEAUTY BALM CREAM SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130105 OTC MONOGRAPH FINAL part352 PHYSICIANS FORMULA INC TITANIUM DIOXIDE; ZINC OXIDE 5.76; 2.94 g/100g; g/100g E 20171231 31645-165_23e7762d-8b78-6578-e054-00144ff88e88 31645-165 HUMAN OTC DRUG SUPER BB All-in-1 Beauty Balm Powder SPF 30 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20121227 OTC MONOGRAPH FINAL part352 PHYSICIANS FORMULA INC TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g E 20171231 31645-166_24b24635-6a5c-1182-e054-00144ff88e88 31645-166 HUMAN OTC DRUG Mineral Wear Talc-Free Mineral Liquid Foundation SPF 15 Titanium Dioxide CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE 16 g/100g E 20171231 31645-167_24eaf989-b61f-292a-e054-00144ff8d46c 31645-167 HUMAN OTC DRUG Mineral Wear Oh So Radiant Powder SPF 20 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20131201 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 10; 10 g/100g; g/100g E 20171231 31645-168_24eaf5cc-fddf-3d9a-e054-00144ff8d46c 31645-168 HUMAN OTC DRUG Bronze Booster Beauty Balm BB Bronzer SPF 20 Titanium Dioxide POWDER TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE 6 g/100g E 20171231 31645-169_24b29738-4589-5656-e054-00144ff8d46c 31645-169 HUMAN OTC DRUG Organic Wear CC Cream SPF 20 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20131002 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 3.9; 1 g/100g; g/100g E 20171231 31645-170_24c624a3-e189-5274-e054-00144ff8d46c 31645-170 HUMAN OTC DRUG Super BB All-in-One Compact Cream SPF 30 Titanium Dioxide, Zinc Oxide PASTE TOPICAL 20131201 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 3.52; 4.48 g/100g; g/100g E 20171231 31645-171_24c69901-ea27-247c-e054-00144ff88e88 31645-171 HUMAN OTC DRUG Bronze Booster BB Cream SPF 20 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 3.84; 1.96 g/100g; g/100g E 20171231 31645-172_24c6cfaf-dab3-6220-e054-00144ff8d46c 31645-172 HUMAN OTC DRUG Super CC Plus Concealer SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 5.8; 6 g/100g; g/100g E 20171231 31645-173_24c77b91-604e-0df3-e054-00144ff8d46c 31645-173 HUMAN OTC DRUG Super CC Plus Cream SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 5.76; 2.94 g/100g; g/100g E 20171231 31645-174_24c71ccc-3cbe-01f9-e054-00144ff8d46c 31645-174 HUMAN OTC DRUG Youthful Wear Spotless Concealer SPF 15 Octinoxate LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Physicians Formula Inc OCTINOXATE 3 g/100g E 20171231 31645-175_24c7ac99-bc96-4c16-e054-00144ff88e88 31645-175 HUMAN OTC DRUG Youthful Wear Spotless Foundation SPF 15 octinoxate LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Physicians Formula Inc OCTINOXATE 3 g/100g E 20171231 31645-176_24c71ccc-3cb6-01f9-e054-00144ff8d46c 31645-176 HUMAN OTC DRUG Super CC Plus Powder SPF 30 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Physicians Formula TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g E 20171231 31645-177_244f1c74-afa7-4dbd-e054-00144ff8d46c 31645-177 HUMAN OTC DRUG Youthful Wear Spotless Powder SPF 15 Titanium Dioxide POWDER TOPICAL 20131201 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE 2 g/100g E 20171231 31645-178_23e7fd90-6f5b-42d3-e054-00144ff8d46c 31645-178 HUMAN OTC DRUG Super BB All in One Cheek and Lip Octinoxate, Zinc Oxide STICK TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc OCTINOXATE; ZINC OXIDE 7.5; 3.26 g/100g; g/100g E 20171231 31645-179_2421711a-1ced-081b-e054-00144ff8d46c 31645-179 HUMAN OTC DRUG Super CC Color Correction Care Instant Blurring Eye Cream Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc ZINC OXIDE; TITANIUM DIOXIDE 2.96; 5.4 g/100g; g/100g E 20171231 31645-180_2421ca12-8c19-7274-e054-00144ff88e88 31645-180 HUMAN OTC DRUG Youthful Wear Cosmeceutical Youth Boosting Spotless CC Cream Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc ZINC OXIDE; TITANIUM DIOXIDE 2.96; 5.4 g/100g; g/100g E 20171231 31645-181_2421f253-dd4d-20c5-e054-00144ff8d46c 31645-181 HUMAN OTC DRUG Organic Wear BB All in One Beauty Balm Cream Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc ZINC OXIDE; TITANIUM DIOXIDE 1; 3.9 g/100g; g/100g E 20171231 31645-182_24231959-0629-2f2d-e054-00144ff88e88 31645-182 HUMAN OTC DRUG Super BB All in One Beauty Balm Stick Titanium Dioxide, Zinc Oxide STICK TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 5.76; 2.96 g/100g; g/100g E 20171231 31645-183_24231959-062f-2f2d-e054-00144ff88e88 31645-183 HUMAN OTC DRUG Super BB All in One Beauty Balm Bronzer and Blush Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 15; 10 g/100g; g/100g E 20171231 31645-184_24231959-0632-2f2d-e054-00144ff88e88 31645-184 HUMAN OTC DRUG Super CC Color Correction Care CC Compact Cream Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc ZINC OXIDE; TITANIUM DIOXIDE 4.54; 3.53 g/100g; g/100g E 20171231 31645-185_2421ab1e-bca9-10be-e054-00144ff8d46c 31645-185 HUMAN OTC DRUG Argan Wear Ultra Nourishing Argan Oil BB Cream Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 5.76; 2.96 g/100g; g/100g E 20171231 31645-186_24232fe6-9a32-2f7b-e054-00144ff88e88 31645-186 HUMAN OTC DRUG City Glow Daily Defense Bronzer Titanium Dioxide POWDER TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE 15 g/100g E 20171231 31645-187_2551217f-45cb-4d6b-e054-00144ff88e88 31645-187 HUMAN OTC DRUG Super BB InstaReady Beauty Balm BB Cream Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20151124 OTC MONOGRAPH FINAL part352 Physicians Formula Inc ZINC OXIDE; TITANIUM DIOXIDE 2.96; 5.76 g/100g; g/100g E 20171231 31645-188_255230d8-d791-6e59-e054-00144ff88e88 31645-188 HUMAN OTC DRUG Super BB InstaReady Contour Trio BB Stick Titanium Dioxide, Zinc Oxide STICK TOPICAL 20151124 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE; ZINC OXIDE 5.76; 2.96 g/100g; g/100g E 20171231 31645-189_29c87036-c930-7066-e054-00144ff88e88 31645-189 HUMAN OTC DRUG Super CC Color Correction Care Primer Stick SPF 30 Octinoxate, Octocrylene, Oxybenzone,Titanium Dioxide, Zinc Oxide STICK TOPICAL 20160115 OTC MONOGRAPH FINAL part352 Physicians Formula Inc OXYBENZONE; ZINC OXIDE; OCTOCRYLENE; OCTINOXATE; TITANIUM DIOXIDE 5.1; 4; 4.2; 5.6; 5.2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 31645-190_2a32ad22-ea76-128e-e054-00144ff88e88 31645-190 HUMAN OTC DRUG Super BB InstaReady Filter Trio BB Powder Titanium Dioxide POWDER TOPICAL 20160101 OTC MONOGRAPH FINAL part352 Physicians Formula, Inc. TITANIUM DIOXIDE 12 g/100g E 20171231 31645-191_2a41c321-1dcb-5d38-e054-00144ff8d46c 31645-191 HUMAN OTC DRUG Super BB InstaReady Filter BB Bronzer Titanium Dioxide POWDER TOPICAL 20160101 OTC MONOGRAPH FINAL part352 Physicians Formula Inc TITANIUM DIOXIDE 12 g/100g E 20171231 31645-192_2a41fdd9-9fa8-4e10-e054-00144ff88e88 31645-192 HUMAN OTC DRUG Super CC Color-Corection Care All Over Blur Stick Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide STICK TOPICAL 20160101 OTC MONOGRAPH FINAL part352 Physicians Formula, Inc. OCTOCRYLENE; OXYBENZONE; OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 4.2; 5.1; 5.6; 4; 5.2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 31645-193_2a426e58-22ab-7320-e054-00144ff8d46c 31645-193 HUMAN OTC DRUG Super CC Color-Correction Care All Over Blur CC Cream Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160101 OTC MONOGRAPH FINAL part352 Physicians Formula, Inc TITANIUM DIOXIDE; ZINC OXIDE 2.3; 6.3 g/100g; g/100g E 20171231 31645-194_3e9dd4fc-4daf-2816-e054-00144ff88e88 31645-194 HUMAN OTC DRUG Argan Wear Ultra-Nourishing Argan Oil BB Concealer Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160101 OTC MONOGRAPH FINAL part352 Physicians Formula, Inc ZINC OXIDE; TITANIUM DIOXIDE 2.96; 5.76 g/100g; g/100g E 20171231 31645-195_3e9fa6a6-ac2d-4f81-e054-00144ff8d46c 31645-195 HUMAN OTC DRUG Mineral Wear All-in-1 ABC Cushion Foundation Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160101 OTC MONOGRAPH FINAL part352 Physicians Formula, Inc. TITANIUM DIOXIDE; ZINC OXIDE 8.4; 3.95 g/100g; g/100g E 20171231 31645-196_3ea04f9d-d173-6b7d-e054-00144ff8d46c 31645-196 HUMAN OTC DRUG Organic Wear Work It Marathonista Tinted Moisturizer Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160101 OTC MONOGRAPH FINAL part352 Physicians Formula TITANIUM DIOXIDE; ZINC OXIDE 3.92; 1 g/100g; g/100g N 20181231 31645-197_4031eb5b-baf7-54d4-e054-00144ff88e88 31645-197 HUMAN OTC DRUG Mineral Wear Talc Free Cushion Corrector Primer Duo SPF 20 Titanium Dioxide, Zinc Oxide LIQUID TOPICAL 20161115 OTC MONOGRAPH NOT FINAL part352 Physicians Formula, Inc. ZINC OXIDE; TITANIUM DIOXIDE 4.9; 4.15 g/100g; g/100g N 20181231 31645-198_403236d1-4bae-671a-e054-00144ff88e88 31645-198 HUMAN OTC DRUG InstaReady Full Coverage Concealer SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20161115 OTC MONOGRAPH NOT FINAL part352 Physicians Formula, Inc. ZINC OXIDE; TITANIUM DIOXIDE 3.95; 3.92 g/100g; g/100g N 20181231 31645-199_40332eef-c258-005c-e054-00144ff88e88 31645-199 HUMAN OTC DRUG InstaReady Face Primer SPF 18 Avobenzone, Homosalate, Octisalate, Octocrylene LIQUID TOPICAL 20161115 OTC MONOGRAPH NOT FINAL part352 Physicians Formula, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE 3.5; 4; 2.8; 4 g/100g; g/100g; g/100g; g/100g N 20181231 31645-200_5ad645e0-9947-7f6c-e053-2a91aa0ac690 31645-200 HUMAN OTC DRUG The Healthy Foundation SPF 20 Octinoxate CREAM TOPICAL 20171010 OTC MONOGRAPH NOT FINAL part352 Physicians Formula, Inc. OCTINOXATE 3 g/100mL N 20181231 31720-202_26a42801-7d81-162d-e054-00144ff88e88 31720-202 HUMAN OTC DRUG Sephora 8hr Mattifying Moisturizer Sunscreen Broad Spectrum SPF 20 AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20121119 OTC MONOGRAPH FINAL part352 S+ AVOBENZONE; OCTINOXATE; OCTOCRYLENE 30; 75; 23.7 mg/mL; mg/mL; mg/mL E 20171231 31720-211_aea4a9ea-3caa-4dba-b5e5-b70192098e29 31720-211 HUMAN OTC DRUG SEPHORA Acne-Fighting Mattifying Moisturizer SALICYLIC ACID CREAM TOPICAL 20130117 OTC MONOGRAPH FINAL part333D S+ SALICYLIC ACID 20 mg/mL E 20171231 31720-501_2ee26677-6f6f-3a42-e054-00144ff8d46c 31720-501 HUMAN OTC DRUG SEPHORA ROUGE BALM SUNSCREEN SPF20 B01-Delicate Pink OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20151217 OTC MONOGRAPH FINAL part352 S+ OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.125; 3; 1.83 mg/g; mg/g; mg/g E 20171231 31720-502_2ee14dca-57be-0928-e054-00144ff8d46c 31720-502 HUMAN OTC DRUG SEPHORA ROUGE BALM SUNSCREEN SPF20 B03-Enchanting Blush OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20151217 OTC MONOGRAPH FINAL part352 S+ OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.125; 3; 1.83 mg/g; mg/g; mg/g E 20171231 31720-503_2ee26677-6f70-3a42-e054-00144ff8d46c 31720-503 HUMAN OTC DRUG SEPHORA ROUGE BALM SUNSCREEN SPF20 B04-Sweet Fuchsia OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH FINAL part352 S+ OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.125; 3; 1.83 mg/g; mg/g; mg/g E 20171231 31720-504_2ee14dca-57c1-0928-e054-00144ff8d46c 31720-504 HUMAN OTC DRUG SEPHORA ROUGE BALM SUNSCREEN SPF20 B05-Gentle Coral OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20151219 OTC MONOGRAPH FINAL part352 S+ OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.125; 3; 1.83 mg/g; mg/g; mg/g E 20171231 31720-505_2ee27cb2-e2bc-2293-e054-00144ff88e88 31720-505 HUMAN OTC DRUG SEPHORA ROUGE BALM SUNSCREEN SPF20 B06-Soft Red OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20151219 OTC MONOGRAPH FINAL part352 S+ OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.125; 3; 1.83 mg/g; mg/g; mg/g E 20171231 31720-506_2ee27cb2-e2bd-2293-e054-00144ff88e88 31720-506 HUMAN OTC DRUG SEPHORA ROUGE BALM SUNSCREEN SPF20 B07-Bashful Beige OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20151219 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.125; 3; 1.83 mg/g; mg/g; mg/g E 20171231 31720-507_2ee1adfb-b2d7-6b93-e054-00144ff88e88 31720-507 HUMAN OTC DRUG SEPHORA ROUGE BALM SUNSCREEN SPF20 B08-Subtle Peony OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20151219 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.125; 3; 1.83 mg/g; mg/g; mg/g E 20171231 31720-508_2ee1adfb-b2d8-6b93-e054-00144ff88e88 31720-508 HUMAN OTC DRUG SEPHORA ROUGE BALM SUNSCREEN SPF20 B09-Mild Plum OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.125; 3; 1.83 mg/g; mg/g; mg/g E 20171231 31720-509_27344282-a3c0-2c6f-e054-00144ff88e88 31720-509 HUMAN OTC DRUG TOTAL AGE DEFY SPF 15 SUNSCREEN ENSULIZOLE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20151217 OTC MONOGRAPH NOT FINAL part352 S+ ENSULIZOLE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 17; 74.96; 50; 17; 4.5; 57.75 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 31720-701_57e8fdce-6b5a-bf97-e053-2a91aa0a2d3c 31720-701 HUMAN OTC DRUG Bright future skin tint SPF 25 7 ivoire clair light OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; TITANIUM DIOXIDE 74.9; 22.8 mg/mL; mg/mL N 20181231 31720-702_57e90a19-e2b2-cb7d-e053-2a91aa0a73b5 31720-702 HUMAN OTC DRUG Bright future skin tint SPF 25 11 ivoire pur pure OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; TITANIUM DIOXIDE 74.9; 22.8 mg/mL; mg/mL N 20181231 31720-703_57e7e6e1-5f51-e8ed-e053-2991aa0a1368 31720-703 HUMAN OTC DRUG Bright future skin tint SPF 25 12 ecru Ecru OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; TITANIUM DIOXIDE 74.9; 22.8 mg/mL; mg/mL N 20181231 31720-704_57e92d12-cf9d-f789-e053-2a91aa0a9545 31720-704 HUMAN OTC DRUG Bright future skin tint SPF 25 31 amande Almond OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; TITANIUM DIOXIDE 74.9; 22.8 mg/mL; mg/mL N 20181231 31720-705_57e90a19-e2c1-cb7d-e053-2a91aa0a73b5 31720-705 HUMAN OTC DRUG Bright future skin tint SPF 25 46 noix de pecan Pecan OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; TITANIUM DIOXIDE 74.9; 22.8 mg/mL; mg/mL N 20181231 31720-706_57e7e6e1-5f60-e8ed-e053-2991aa0a1368 31720-706 HUMAN OTC DRUG Bright future skin tint SPF 25 20 creme OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; TITANIUM DIOXIDE 74.9; 22.8 mg/mL; mg/mL N 20181231 31720-707_57e8fdce-6b69-bf97-e053-2a91aa0a2d3c 31720-707 HUMAN OTC DRUG Bright future skin tint SPF 25 25 beige Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; TITANIUM DIOXIDE 74.9; 22.8 mg/mL; mg/mL N 20181231 31720-708_57e90a19-e2d0-cb7d-e053-2a91aa0a73b5 31720-708 HUMAN OTC DRUG Bright future skin tint SPF 25 33 noix Walnut OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; TITANIUM DIOXIDE 74.9; 22.8 mg/mL; mg/mL N 20181231 31720-709_57e7e6e1-5f6f-e8ed-e053-2991aa0a1368 31720-709 HUMAN OTC DRUG Bright future skin tint SPF 25 35 bronze OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; TITANIUM DIOXIDE 74.9; 22.8 mg/mL; mg/mL N 20181231 31720-710_57e90a19-e2df-cb7d-e053-2a91aa0a73b5 31720-710 HUMAN OTC DRUG Bright future skin tint SPF 25 44 Praline OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part352 S+ OCTINOXATE; TITANIUM DIOXIDE 74.9; 22.8 mg/mL; mg/mL N 20181231 31722-131_b3e02091-349c-46f7-8a19-7770f77bed6b 31722-131 HUMAN PRESCRIPTION DRUG Dutasteride Dutasteride CAPSULE, LIQUID FILLED ORAL 20161024 ANDA ANDA206574 Camber Pharmaceuticals, Inc. DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 31722-139_9d688237-1727-46ca-ba3c-efd830b12421 31722-139 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil TABLET, FILM COATED ORAL 20161007 ANDA ANDA203907 Camber Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 31722-140_9d688237-1727-46ca-ba3c-efd830b12421 31722-140 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil TABLET, FILM COATED ORAL 20161007 ANDA ANDA203907 Camber Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 31722-160_0f3408b4-44be-4a92-a59f-9b5a9716bc9a 31722-160 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20161006 ANDA ANDA204774 Camber Pharmaceuticals, Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-161_0f3408b4-44be-4a92-a59f-9b5a9716bc9a 31722-161 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20161006 ANDA ANDA204774 Camber Pharmaceuticals, Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-162_0f3408b4-44be-4a92-a59f-9b5a9716bc9a 31722-162 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20161006 ANDA ANDA204774 Camber Pharmaceuticals, Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-173_9cb89533-5ff1-423e-8fef-bc9ec5d256f2 31722-173 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20151001 ANDA ANDA207416 Camber Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 31722-174_9cb89533-5ff1-423e-8fef-bc9ec5d256f2 31722-174 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20151001 ANDA ANDA207416 Camber Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 31722-175_9cb89533-5ff1-423e-8fef-bc9ec5d256f2 31722-175 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20151001 ANDA ANDA207416 Camber Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 31722-191_fcd26b49-3803-4cae-8d73-67de04de9c3c 31722-191 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20170411 ANDA ANDA207419 Camber Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 31722-192_fcd26b49-3803-4cae-8d73-67de04de9c3c 31722-192 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20170411 ANDA ANDA207419 Camber Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 31722-193_fcd26b49-3803-4cae-8d73-67de04de9c3c 31722-193 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20170411 ANDA ANDA207419 Camber Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 31722-194_fcd26b49-3803-4cae-8d73-67de04de9c3c 31722-194 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20170411 ANDA ANDA207419 Camber Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 31722-200_29914956-c794-4806-b038-f0784b9db3d3 31722-200 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Camber Pharmceuticals Inc. FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-201_29914956-c794-4806-b038-f0784b9db3d3 31722-201 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Camber Pharmceuticals Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-202_29914956-c794-4806-b038-f0784b9db3d3 31722-202 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Camber Pharmceuticals Inc. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-206_d16fcdcc-14b9-430f-9b14-900f8c2d3f84 31722-206 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Camber Pharmaceuticals CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 31722-207_d16fcdcc-14b9-430f-9b14-900f8c2d3f84 31722-207 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Camber Pharmaceuticals CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 31722-208_d16fcdcc-14b9-430f-9b14-900f8c2d3f84 31722-208 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Camber Pharmaceuticals CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 31722-209_f3186a46-2fe9-4e3e-bb0a-f8dc4412ad30 31722-209 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine TABLET ORAL 20110101 ANDA ANDA077533 Camber Pharmaceuticals, Inc. TERBINAFINE HYDROCHLORIDE 250 1/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] E 20171231 31722-212_5616a898-fc8c-4bc5-87eb-62084fea396d 31722-212 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Camber Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 31722-213_5616a898-fc8c-4bc5-87eb-62084fea396d 31722-213 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Camber Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 31722-214_5616a898-fc8c-4bc5-87eb-62084fea396d 31722-214 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Camber Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 31722-218_c91afeb7-1f26-4fdc-b1d2-4a11f2e6a88b 31722-218 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130801 ANDA ANDA090294 Camber Pharmaceutical, Inc. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 31722-219_c91afeb7-1f26-4fdc-b1d2-4a11f2e6a88b 31722-219 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130801 ANDA ANDA090294 Camber Pharmaceutical, Inc. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 31722-220_c91afeb7-1f26-4fdc-b1d2-4a11f2e6a88b 31722-220 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130801 ANDA ANDA090294 Camber Pharmaceutical, Inc. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 31722-221_edc0e13b-6531-4233-a98c-42a06ce94c37 31722-221 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Camber Pharmaceuticals Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 31722-222_edc0e13b-6531-4233-a98c-42a06ce94c37 31722-222 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Camber Pharmaceuticals Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 31722-223_edc0e13b-6531-4233-a98c-42a06ce94c37 31722-223 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Camber Pharmaceuticals Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 31722-225_183f6e6f-ebb2-410e-9181-3558f0d37a4c 31722-225 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110101 ANDA ANDA077836 Camber Pharmaceuticals GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 31722-228_62729c28-3535-4195-9218-33a9039e4eae 31722-228 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20120221 ANDA ANDA077869 Camber Pharmaceuticals ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 31722-237_0cb6772a-957b-4193-bdaa-270ae69f6c1f 31722-237 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Camber Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 31722-238_0cb6772a-957b-4193-bdaa-270ae69f6c1f 31722-238 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Camber Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 31722-239_0cb6772a-957b-4193-bdaa-270ae69f6c1f 31722-239 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Camber Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 31722-249_e280a343-4949-4c92-96f7-5744d8cf52c9 31722-249 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 Camber Pharmaceuticals ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 31722-250_e280a343-4949-4c92-96f7-5744d8cf52c9 31722-250 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 Camber Pharmaceuticals ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 31722-251_e280a343-4949-4c92-96f7-5744d8cf52c9 31722-251 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 Camber Pharmaceuticals ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 31722-256_46a8448f-fd60-4043-ae6a-512d67d50cc2 31722-256 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET ORAL 20140924 ANDA ANDA090842 Camber Pharmaceuticals Inc RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 31722-267_14c61e16-bb9d-4ba9-870a-1c8228f95a2f 31722-267 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120120 ANDA ANDA078457 Camber Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-268_14c61e16-bb9d-4ba9-870a-1c8228f95a2f 31722-268 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120120 ANDA ANDA078457 Camber Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-269_14c61e16-bb9d-4ba9-870a-1c8228f95a2f 31722-269 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120120 ANDA ANDA078457 Camber Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-270_14c61e16-bb9d-4ba9-870a-1c8228f95a2f 31722-270 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120120 ANDA ANDA078457 Camber Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-271_235c5540-0408-43d8-80bb-b8e31ed815e7 31722-271 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110101 ANDA ANDA078745 Camber Pharmaceuticals RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-272_235c5540-0408-43d8-80bb-b8e31ed815e7 31722-272 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110101 ANDA ANDA078745 Camber Pharmaceuticals RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-273_235c5540-0408-43d8-80bb-b8e31ed815e7 31722-273 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110101 ANDA ANDA078745 Camber Pharmaceuticals RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-274_235c5540-0408-43d8-80bb-b8e31ed815e7 31722-274 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110101 ANDA ANDA078745 Camber Pharmaceuticals RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-278_6be89e4b-831c-46d6-a4c0-1c2ab53d2d22 31722-278 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Camber Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 31722-279_6be89e4b-831c-46d6-a4c0-1c2ab53d2d22 31722-279 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Camber Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 31722-280_6be89e4b-831c-46d6-a4c0-1c2ab53d2d22 31722-280 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Camber Pharmaceuticals, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 31722-281_6be89e4b-831c-46d6-a4c0-1c2ab53d2d22 31722-281 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Camber Pharmaceuticals, Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 31722-282_8b931a82-f7b1-4569-aff8-da927068ac39 31722-282 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 ANDA ANDA090478 Camber Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 31722-283_8b931a82-f7b1-4569-aff8-da927068ac39 31722-283 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 ANDA ANDA090478 Camber Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 31722-302_3fb33b8f-9ec4-4a4b-a520-de154673cfb0 31722-302 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride extended release Alfuzosin Hydrochloride TABLET ORAL 20120118 ANDA ANDA090284 Camber Pharmaceuticals ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 31722-327_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-327 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 31722-328_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-328 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 31722-329_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-329 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 31722-330_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-330 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 31722-331_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-331 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 31722-332_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-332 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 31722-333_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-333 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 31722-334_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-334 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 31722-335_36f616b7-36d8-41b0-8dde-8b9007f433a3 31722-335 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Camber Pharmaceuticals WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 31722-338_35bc8579-bca9-46a2-9303-5bcb760470d6 31722-338 HUMAN PRESCRIPTION DRUG Naproxen delayed release Naproxen TABLET ORAL 20120123 ANDA ANDA091432 Camber Pharmaceuticals NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 31722-339_35bc8579-bca9-46a2-9303-5bcb760470d6 31722-339 HUMAN PRESCRIPTION DRUG Naproxen delayed release Naproxen TABLET ORAL 20120123 ANDA ANDA091432 Camber Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 31722-340_3466d710-2b9c-402a-9a88-a15411c974ed 31722-340 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120123 ANDA ANDA091305 Camber Pharmaceuticals NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 31722-341_3466d710-2b9c-402a-9a88-a15411c974ed 31722-341 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120123 ANDA ANDA091305 Camber Pharmaceuticals NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 31722-342_3466d710-2b9c-402a-9a88-a15411c974ed 31722-342 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120123 ANDA ANDA091305 Camber Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 31722-347_32deca47-c3a3-4b1e-80ad-22e4b1500282 31722-347 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20160127 ANDA ANDA203455 Camber, Pharmaceuticals Inc NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 31722-348_32deca47-c3a3-4b1e-80ad-22e4b1500282 31722-348 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20160127 ANDA ANDA203455 Camber, Pharmaceuticals Inc NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 31722-349_32deca47-c3a3-4b1e-80ad-22e4b1500282 31722-349 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20160127 ANDA ANDA203455 Camber, Pharmaceuticals Inc NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 31722-359_f8c27541-e9d7-4045-82f7-db4729db7273 31722-359 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20140402 ANDA ANDA202942 Camber Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 31722-374_d32a5dbc-7a55-421a-bf8d-68dbb6eb8c3d 31722-374 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET ORAL 20111215 ANDA ANDA201356 Camber Pharmaceuticals QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 31722-375_d32a5dbc-7a55-421a-bf8d-68dbb6eb8c3d 31722-375 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET ORAL 20111215 ANDA ANDA201356 Camber Pharmaceuticals QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 31722-376_d32a5dbc-7a55-421a-bf8d-68dbb6eb8c3d 31722-376 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET ORAL 20111215 ANDA ANDA201356 Camber Pharmaceuticals QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 31722-377_0cefa71a-1ab0-4e69-b6b6-b4070dd1e4b8 31722-377 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20140203 ANDA ANDA203135 Camber Pharmaceuticals, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 31722-393_3af1f87c-2e11-47a7-8ace-719dafaac0be 31722-393 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate TABLET ORAL 20140203 ANDA ANDA202420 Camber Pharmaceuticals, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 31722-405_192c9a1b-374e-4ec3-a915-05495365d1d8 31722-405 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20121029 ANDA ANDA202764 Camber Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 31722-406_192c9a1b-374e-4ec3-a915-05495365d1d8 31722-406 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20121029 ANDA ANDA202764 Camber Pharmaceuticals, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 31722-417_059f5795-5de9-4a69-bced-580cf6272799 31722-417 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20131115 ANDA ANDA203508 Camber Pharmaceuticals Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-418_059f5795-5de9-4a69-bced-580cf6272799 31722-418 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20131115 ANDA ANDA203508 Camber Pharmaceuticals Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-419_059f5795-5de9-4a69-bced-580cf6272799 31722-419 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20131115 ANDA ANDA203508 Camber Pharmaceuticals Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-420_059f5795-5de9-4a69-bced-580cf6272799 31722-420 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20131115 ANDA ANDA203508 Camber Pharmaceuticals Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-421_059f5795-5de9-4a69-bced-580cf6272799 31722-421 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20131115 ANDA ANDA203508 Camber Pharmaceuticals Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-422_059f5795-5de9-4a69-bced-580cf6272799 31722-422 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20131115 ANDA ANDA203508 Camber Pharmaceuticals Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 31722-458_117e0844-95dd-4d5c-88b5-e02a2a3a3125 31722-458 HUMAN PRESCRIPTION DRUG ZOLMITRIPTAN ZOLMITRIPTAN TABLET, FILM COATED ORAL 20150105 ANDA ANDA204284 Camber Pharmaceuticals Inc ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 31722-459_117e0844-95dd-4d5c-88b5-e02a2a3a3125 31722-459 HUMAN PRESCRIPTION DRUG ZOLMITRIPTAN ZOLMITRIPTAN TABLET, FILM COATED ORAL 20150105 ANDA ANDA204284 Camber Pharmaceuticals Inc ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 31722-462_0a082c01-3106-4954-9228-dfaf19c6dadb 31722-462 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20150129 ANDA ANDA204339 Camber Pharmaceuticals, Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 31722-463_0a082c01-3106-4954-9228-dfaf19c6dadb 31722-463 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20150129 ANDA ANDA204339 Camber Pharmaceuticals, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 31722-500_f7e527fe-2f67-45ad-a3ec-146ead819514 31722-500 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA040805 Camber Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 31722-501_f7e527fe-2f67-45ad-a3ec-146ead819514 31722-501 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA040805 Camber Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 31722-502_f7e527fe-2f67-45ad-a3ec-146ead819514 31722-502 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA040805 Camber Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 31722-505_8e6a89e9-79ce-4533-bfe4-8c53bb7ec12f 31722-505 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET ORAL 20120523 ANDA ANDA078584 Camber Pharmaceuticals, Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 31722-506_861cbfc7-ae8d-4a31-a284-3d95cfffa69b 31722-506 HUMAN PRESCRIPTION DRUG LAMIVUDINE and ZIDOVUDINE LAMIVUDINE and ZIDOVUDINE TABLET, FILM COATED ORAL 20150918 ANDA ANDA079124 Camber Pharmaceuticals, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 31722-509_17d3e8e2-7532-48ea-aa17-cef1c947e516 31722-509 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET ORAL 20110101 ANDA ANDA090092 Camber Pharmaceuticals ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 31722-510_0f51de61-8914-4482-9e45-15a59a4940e7 31722-510 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141209 ANDA ANDA200895 Camber Pharmaceuticals, Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 31722-511_0f51de61-8914-4482-9e45-15a59a4940e7 31722-511 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141209 ANDA ANDA200895 Camber Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 31722-512_0f51de61-8914-4482-9e45-15a59a4940e7 31722-512 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141209 ANDA ANDA200895 Camber Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 31722-513_0f51de61-8914-4482-9e45-15a59a4940e7 31722-513 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141203 ANDA ANDA200895 Camber Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 31722-514_0f51de61-8914-4482-9e45-15a59a4940e7 31722-514 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141209 ANDA ANDA200895 Camber Pharmaceuticals, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 31722-515_47401c88-8cae-4352-9942-94fbc43e856a 31722-515 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA078957 Camber Pharmaceuticals, Inc. STAVUDINE 15 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 31722-516_47401c88-8cae-4352-9942-94fbc43e856a 31722-516 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA078957 Camber Pharmaceuticals, Inc. STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 31722-517_47401c88-8cae-4352-9942-94fbc43e856a 31722-517 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA078957 Camber Pharmaceuticals, Inc. STAVUDINE 30 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 31722-518_47401c88-8cae-4352-9942-94fbc43e856a 31722-518 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA078957 Camber Pharmaceuticals, Inc. STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 31722-519_0801cbcc-560f-48ae-9b56-86204079df4d 31722-519 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Camber Pharmaceuticals HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 31722-520_0801cbcc-560f-48ae-9b56-86204079df4d 31722-520 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Camber Pharmaceuticals HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 31722-521_0801cbcc-560f-48ae-9b56-86204079df4d 31722-521 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Camber Pharmaceuticals HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 31722-522_0801cbcc-560f-48ae-9b56-86204079df4d 31722-522 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Camber Pharmaceuticals HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 31722-525_509abf9e-c201-4189-9499-01562e8afdd3 31722-525 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20150613 ANDA ANDA090061 Camber Pharmaceuticals, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 31722-526_0ebbabf3-0681-484d-ab8d-58e670d80a0d 31722-526 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130701 ANDA ANDA090060 Camber Pharmaceuticals, Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 31722-529_be7e52d8-efe4-4965-a69f-2b6a71aad296 31722-529 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Camber Pharmaceuticals, Inc. TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 31722-530_be7e52d8-efe4-4965-a69f-2b6a71aad296 31722-530 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Camber Pharmaceuticals, Inc. TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 31722-531_be7e52d8-efe4-4965-a69f-2b6a71aad296 31722-531 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Camber Pharmaceuticals, Inc. TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 31722-532_be7e52d8-efe4-4965-a69f-2b6a71aad296 31722-532 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Camber Pharmaceuticals, Inc. TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 31722-533_12fafa1f-a903-4046-a8f1-8ee030009cba 31722-533 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Camber Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 31722-534_12fafa1f-a903-4046-a8f1-8ee030009cba 31722-534 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Camber Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 31722-536_2cd73426-cb79-46f7-a932-7d8056beb94a 31722-536 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120109 ANDA ANDA090515 Camber Pharmaceuticals LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 31722-537_2cd73426-cb79-46f7-a932-7d8056beb94a 31722-537 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120109 ANDA ANDA090515 Camber Pharmaceuticals LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 31722-538_2cd73426-cb79-46f7-a932-7d8056beb94a 31722-538 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120109 ANDA ANDA090515 Camber Pharmaceuticals LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 31722-539_2cd73426-cb79-46f7-a932-7d8056beb94a 31722-539 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120109 ANDA ANDA090515 Camber Pharmaceuticals LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 31722-542_8c496175-d88e-441f-bfd6-0b179ad0571f 31722-542 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 Camber Pharmaceuticals INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 31722-543_8c496175-d88e-441f-bfd6-0b179ad0571f 31722-543 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 Camber Pharmaceuticals INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 31722-544_646e3c3b-40e9-45bf-983f-e0f157cd3293 31722-544 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 Camber Pharmaceuticals Inc. LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] N 20181231 31722-545_646e3c3b-40e9-45bf-983f-e0f157cd3293 31722-545 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 Camber Pharmaceuticals Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 31722-546_646e3c3b-40e9-45bf-983f-e0f157cd3293 31722-546 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 Camber Pharmaceuticals Inc. LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] N 20181231 31722-551_18537a1c-a3c0-4391-8904-963fc6e90aeb 31722-551 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20120629 ANDA ANDA091264 Camber Pharmaceuticals, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 31722-557_4627e44f-b217-429c-9b36-012de2c729de 31722-557 HUMAN PRESCRIPTION DRUG Abacavir Abacavir TABLET ORAL 20130918 ANDA ANDA091560 Camber Pharmaceuticals, Inc. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 31722-562_34da1f28-8687-4286-a674-ac3cb61440f5 31722-562 HUMAN PRESCRIPTION DRUG Abacavir Abacavir SOLUTION ORAL 20160926 ANDA ANDA201107 Camber Pharmaceuticals, Inc. ABACAVIR SULFATE 20 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 31722-564_dc7b3f88-ee55-4e3e-9ed4-fc06aa7620cc 31722-564 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide SOLUTION ORAL 20151221 ANDA ANDA201450 Camber Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 10 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 31722-565_d48dd7ef-9ed0-4e70-b87e-bd5428cc2b91 31722-565 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20150724 ANDA ANDA201807 Camber Pharmaceuticals, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 31722-569_82d793ee-4039-45fc-ac83-4bd5235f00aa 31722-569 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate SOLUTION ORAL 20120612 ANDA ANDA202221 Camber Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 31722-572_78d1585e-746f-4db7-89f8-24f323853d61 31722-572 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20150921 ANDA ANDA202784 Camber Pharmaceuticals, Inc. ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 31722-573_78d1585e-746f-4db7-89f8-24f323853d61 31722-573 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20150921 ANDA ANDA202784 Camber Pharmaceuticals, Inc. ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 31722-574_26c9d796-7c95-46e2-bd84-84b9816cb9dc 31722-574 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam Levetiracetam SOLUTION ORAL 20150611 ANDA ANDA203052 Camber Pharmaceuticals, Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 31722-581_6ec41372-223f-40e0-b376-a3a4faa0a5d1 31722-581 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20160811 ANDA ANDA204343 Camber Pharmaceuticals, Inc. DULOXETINE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 31722-582_6ec41372-223f-40e0-b376-a3a4faa0a5d1 31722-582 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20160811 ANDA ANDA204343 Camber Pharmaceuticals, Inc. DULOXETINE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 31722-583_6ec41372-223f-40e0-b376-a3a4faa0a5d1 31722-583 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20160811 ANDA ANDA204343 Camber Pharmaceuticals, Inc. DULOXETINE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 31722-595_da9f8c91-31dc-43a9-b3e5-986b46b777ac 31722-595 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20160714 ANDA ANDA204598 Camber Pharmaceuticals, Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 31722-596_da9f8c91-31dc-43a9-b3e5-986b46b777ac 31722-596 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20160714 ANDA ANDA204598 Camber Pharmaceuticals, Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 31722-607_e16012ae-5972-470b-8a22-b0626a029e95 31722-607 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20170602 ANDA ANDA206419 Camber Pharmaceuticals, Inc. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 31722-608_e16012ae-5972-470b-8a22-b0626a029e95 31722-608 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20170602 ANDA ANDA206419 Camber Pharmaceuticals, Inc. TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 31722-700_9dab317a-e810-4e9d-b5cb-bb0181affc10 31722-700 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20150819 ANDA ANDA203835 Camber Pharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-701_9dab317a-e810-4e9d-b5cb-bb0181affc10 31722-701 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20150819 ANDA ANDA203835 Camber Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-702_9dab317a-e810-4e9d-b5cb-bb0181affc10 31722-702 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20150819 ANDA ANDA203835 Camber Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-704_7f5e96e0-534c-47a5-bb79-926088afc73c 31722-704 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20150525 ANDA ANDA203047 Camber Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 31722-705_7f5e96e0-534c-47a5-bb79-926088afc73c 31722-705 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20150525 ANDA ANDA203047 Camber Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 31722-706_934248e2-f32d-4be3-9226-74a153c18ba4 31722-706 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20140910 ANDA ANDA202438 Camber Pharmaceuticals, Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 31722-707_934248e2-f32d-4be3-9226-74a153c18ba4 31722-707 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20140910 ANDA ANDA202438 Camber Pharmaceuticals, Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 31722-708_934248e2-f32d-4be3-9226-74a153c18ba4 31722-708 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20140910 ANDA ANDA202438 Camber Pharmaceuticals, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 31722-712_7a151ddb-edab-4a2a-aa57-ac248d036d18 31722-712 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE TABLET, DELAYED RELEASE ORAL 20140910 ANDA ANDA202882 Camber Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 31722-713_7a151ddb-edab-4a2a-aa57-ac248d036d18 31722-713 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE TABLET, DELAYED RELEASE ORAL 20140910 ANDA ANDA202882 Camber Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 31722-721_29d78d3d-5e60-46b6-9317-6ce3d56a96c3 31722-721 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150109 ANDA ANDA202801 Camber Pharmaceuticals, Inc. LEVOFLOXACIN 250 mg/1 N 20181231 31722-722_29d78d3d-5e60-46b6-9317-6ce3d56a96c3 31722-722 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150109 ANDA ANDA202801 Camber Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 31722-723_29d78d3d-5e60-46b6-9317-6ce3d56a96c3 31722-723 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150109 ANDA ANDA202801 Camber Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 31722-726_43db9635-a979-43a1-817a-6d368a110142 31722-726 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, FILM COATED ORAL 20140910 ANDA ANDA202843 Camber Pharmaceuticals, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 31722-727_cd08fa68-33ec-4627-b399-03d038cc00c2 31722-727 HUMAN PRESCRIPTION DRUG montelukast sodium montelukast sodium TABLET, CHEWABLE ORAL 20150527 ANDA ANDA204093 Camber Pharmaceuticals, Inc. MONTELUKAST 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 31722-728_cd08fa68-33ec-4627-b399-03d038cc00c2 31722-728 HUMAN PRESCRIPTION DRUG montelukast sodium montelukast sodium TABLET, CHEWABLE ORAL 20150527 ANDA ANDA204093 Camber Pharmaceuticals, Inc. MONTELUKAST 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 31722-729_ea56172e-33e4-45a7-932f-549fbbe643c5 31722-729 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120926 ANDA ANDA202910 Camber Pharmaceuticals, Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-730_ea56172e-33e4-45a7-932f-549fbbe643c5 31722-730 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202910 Camber Pharmaceuticals, Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-731_ea56172e-33e4-45a7-932f-549fbbe643c5 31722-731 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202910 Camber Pharmaceuticals, Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-737_a5721a76-5548-4b7e-ac96-21111bf774b6 31722-737 HUMAN PRESCRIPTION DRUG Donepezil Donepezil hydrochloride TABLET ORAL 20150202 ANDA ANDA203034 Camber Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 31722-738_a5721a76-5548-4b7e-ac96-21111bf774b6 31722-738 HUMAN PRESCRIPTION DRUG Donepezil Donepezil hydrochloride TABLET ORAL 20150202 ANDA ANDA203034 Camber Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 31722-739_e816e8f5-1e50-4f49-8bea-92da0121d26e 31722-739 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20140206 ANDA ANDA203259 Camber Pharmaceuticals, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 31722-745_035ec403-ce6f-4a2d-afed-76c5dd91e0b9 31722-745 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA203311 Camber Pharmaceuticals, Inc. VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-746_035ec403-ce6f-4a2d-afed-76c5dd91e0b9 31722-746 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA203311 Camber Pharmaceuticals, Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-747_035ec403-ce6f-4a2d-afed-76c5dd91e0b9 31722-747 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA203311 Camber Pharmaceuticals, Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-748_035ec403-ce6f-4a2d-afed-76c5dd91e0b9 31722-748 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA203311 Camber Pharmaceuticals, Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-749_b239458e-9a3e-49ac-9ac7-a4badc53dff6 31722-749 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20151221 ANDA ANDA204239 Camber Pharmaceuticals, Inc. LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 31722-752_150a3ac2-4c53-4bd4-99c0-d85db1759fda 31722-752 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20140102 ANDA ANDA203260 Camber Pharmaceuticals, Inc. LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 31722-753_92b11dfe-a1fe-47c6-8504-6b00e2c2cf24 31722-753 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20140106 ANDA ANDA203277 Camber Pharmaceuticals, Inc. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 31722-754_92b11dfe-a1fe-47c6-8504-6b00e2c2cf24 31722-754 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20140106 ANDA ANDA203277 Camber Pharmaceuticals, Inc. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 31722-776_d1be5c4f-eff5-4d57-8305-60db2407417d 31722-776 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20141126 ANDA ANDA203623 Camber Pharmaceuticals, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 31722-777_0910335b-6796-459f-b97e-d7ef5439a060 31722-777 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 Camber Pharmaceuticals, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 31722-778_0910335b-6796-459f-b97e-d7ef5439a060 31722-778 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 Camber Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 31722-802_95dc7a73-2c00-4e39-813a-a3f94f5e1b4b 31722-802 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20160425 ANDA ANDA205901 Camber Pharmaceuticals, Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-803_95dc7a73-2c00-4e39-813a-a3f94f5e1b4b 31722-803 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20160425 ANDA ANDA205901 Camber Pharmaceuticals, Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-804_95dc7a73-2c00-4e39-813a-a3f94f5e1b4b 31722-804 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20160425 ANDA ANDA205901 Camber Pharmaceuticals, Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 31722-819_f022c210-1b45-459e-be4f-006e99e92fcb 31722-819 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Camber Pharmaceuticals, Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 31722-820_f022c210-1b45-459e-be4f-006e99e92fcb 31722-820 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Camber Pharmaceuticals, Inc. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 31722-821_3a2ffa8c-f4c5-47e2-8775-5d0edfa55658 31722-821 HUMAN PRESCRIPTION DRUG Tetrabenazine Tetrabenazine TABLET, COATED ORAL 20150817 ANDA ANDA204574 Camber Pharmaceuticals, Inc. TETRABENAZINE 12.5 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20191231 31722-822_3a2ffa8c-f4c5-47e2-8775-5d0edfa55658 31722-822 HUMAN PRESCRIPTION DRUG Tetrabenazine Tetrabenazine TABLET, COATED ORAL 20150817 ANDA ANDA204574 Camber Pharmaceuticals, Inc. TETRABENAZINE 25 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20191231 31722-827_f022c210-1b45-459e-be4f-006e99e92fcb 31722-827 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Camber Pharmaceuticals, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 31722-828_f022c210-1b45-459e-be4f-006e99e92fcb 31722-828 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Camber Pharmaceuticals, Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 31722-829_f022c210-1b45-459e-be4f-006e99e92fcb 31722-829 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Camber Pharmaceuticals, Inc. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 31722-830_f022c210-1b45-459e-be4f-006e99e92fcb 31722-830 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Camber Pharmaceuticals, Inc. ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 31722-832_383e8810-b877-4a4f-abdf-c8c4c8e394f8 31722-832 HUMAN PRESCRIPTION DRUG Valganciclovir Valganciclovir TABLET, FILM COATED ORAL 20160318 ANDA ANDA205166 Camber Pharmaceuticals, Inc. VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 31722-833_b6f5704e-c454-4234-8904-818cd3ed657d 31722-833 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET ORAL 20150821 ANDA ANDA205740 Camber Pharmaceuticals, Inc. ENTECAVIR ANHYDROUS .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 31722-834_b6f5704e-c454-4234-8904-818cd3ed657d 31722-834 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET ORAL 20150821 ANDA ANDA205740 Camber Pharmaceuticals, Inc. ENTECAVIR ANHYDROUS 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 31722-882_2c5c0844-e595-4d1c-b3b6-90f3402365c2 31722-882 HUMAN PRESCRIPTION DRUG Rosuvastatin Rosuvastatin TABLET, FILM COATED ORAL 20161029 ANDA ANDA207616 Camber Pharmaceuticals, Inc. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 31722-883_2c5c0844-e595-4d1c-b3b6-90f3402365c2 31722-883 HUMAN PRESCRIPTION DRUG Rosuvastatin Rosuvastatin TABLET, FILM COATED ORAL 20161029 ANDA ANDA207616 Camber Pharmaceuticals, Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 31722-884_2c5c0844-e595-4d1c-b3b6-90f3402365c2 31722-884 HUMAN PRESCRIPTION DRUG Rosuvastatin Rosuvastatin TABLET, FILM COATED ORAL 20161029 ANDA ANDA207616 Camber Pharmaceuticals, Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 31722-885_2c5c0844-e595-4d1c-b3b6-90f3402365c2 31722-885 HUMAN PRESCRIPTION DRUG Rosuvastatin Rosuvastatin TABLET, FILM COATED ORAL 20161029 ANDA ANDA207616 Camber Pharmaceuticals, Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 31722-901_5ac8bdbe-355f-4271-a45b-cf38522e787d 31722-901 HUMAN PRESCRIPTION DRUG clopidogrel clopidogrel TABLET, FILM COATED ORAL 20160303 ANDA ANDA204165 Camber Pharmaceuticals, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 31722-902_5ac8bdbe-355f-4271-a45b-cf38522e787d 31722-902 HUMAN PRESCRIPTION DRUG clopidogrel clopidogrel TABLET, FILM COATED ORAL 20160303 ANDA ANDA204165 Camber Pharmaceuticals, Inc. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 31722-903_4ed2db42-7efb-4088-b709-b923901e349f 31722-903 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20150730 ANDA ANDA204597 Camber Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 31722-904_4ed2db42-7efb-4088-b709-b923901e349f 31722-904 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20150730 ANDA ANDA204597 Camber Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 31722-905_4ed2db42-7efb-4088-b709-b923901e349f 31722-905 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20150730 ANDA ANDA204597 Camber Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 31722-906_540a17f8-b64d-41e1-a96b-d55bc8c48f3d 31722-906 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE PRAMIPEXOLE TABLET ORAL 20150801 ANDA ANDA203855 Camber Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 31722-907_540a17f8-b64d-41e1-a96b-d55bc8c48f3d 31722-907 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE PRAMIPEXOLE TABLET ORAL 20150801 ANDA ANDA203855 Camber Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 31722-908_540a17f8-b64d-41e1-a96b-d55bc8c48f3d 31722-908 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE PRAMIPEXOLE TABLET ORAL 20150801 ANDA ANDA203855 Camber Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 31722-909_540a17f8-b64d-41e1-a96b-d55bc8c48f3d 31722-909 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE PRAMIPEXOLE TABLET ORAL 20150801 ANDA ANDA203855 Camber Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 31722-910_540a17f8-b64d-41e1-a96b-d55bc8c48f3d 31722-910 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE PRAMIPEXOLE TABLET ORAL 20150801 ANDA ANDA203855 Camber Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 31722-911_540a17f8-b64d-41e1-a96b-d55bc8c48f3d 31722-911 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE PRAMIPEXOLE TABLET ORAL 20150801 ANDA ANDA203855 Camber Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 31722-917_19a4484c-962a-44d2-86e2-2ce06a531901 31722-917 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20170808 ANDA ANDA207418 Camber Pharmaceuticals Inc OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 31722-918_19a4484c-962a-44d2-86e2-2ce06a531901 31722-918 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20170808 ANDA ANDA207418 Camber Pharmaceuticals Inc OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 31774-1001_edd0ca09-7011-496c-b030-af6bc73021bc 31774-1001 HUMAN OTC DRUG SOFT and DRI Soft Scent Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20130102 OTC MONOGRAPH FINAL part350 Golden Sun Inc DBA Newhall Laboratories ALUMINUM CHLOROHYDRATE 200 mg/g N 20181231 31774-1018_fd6f35a4-5c60-4791-8138-ad6f851597ff 31774-1018 HUMAN OTC DRUG Thicker Fuller Hair - Dandruff Sulfate Free Salicylic Acid SHAMPOO TOPICAL 20131216 OTC MONOGRAPH FINAL part358F Golden Sun DBA Newhall Laboratories SALICYLIC ACID 18 mg/mL E 20171231 31774-1046_0440e0d1-c66c-4b04-a6f3-df5d377ee434 31774-1046 HUMAN OTC DRUG SOFT and DRI Clinical Everfresh Blossom Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20140102 OTC MONOGRAPH FINAL part350 Golden Sun Inc DBA Newhall Laboratories ALUMINUM CHLOROHYDRATE 200 mg/g N 20181231 31774-8005_12bf2514-2813-46c3-a3b4-c3425cbeb162 31774-8005 HUMAN OTC DRUG LaBella Linimento Obrero Capsaicin, Menthol, Unspecified Form, and Methyl Salicylate CREAM TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part346 Golden Sun Inc DBA Newhall Laboratories CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .25; 20; 100 mg/mL; mg/mL; mg/mL E 20171231 32267-920_3d8f0f44-ed02-418b-87f9-eff6191df584 32267-920 HUMAN OTC DRUG Gy-Na-Tren Boric Acid, Lactobacillus Acidophilus, Vitamin C KIT 20120430 UNAPPROVED HOMEOPATHIC Natren Inc. N 20181231 32267-940_b3d1e2ee-40f2-4021-9d3c-ba7059040f7b 32267-940 HUMAN OTC DRUG Gy-Na-Tren Boric Acid, Marigold, Coneflower, Arborvitae, Borate of Sodium, Beechwood Kreosote, Wind Flower, Lactobacillus Acidophilus, Vitamin C KIT 20160502 UNAPPROVED HOMEOPATHIC Natren Inc. N 20181231 32472-102_196cb674-64c2-4c81-94bd-ee1f5d1e03ff 32472-102 HUMAN OTC DRUG Analgesic menthol SPRAY TOPICAL 20101228 OTC MONOGRAPH NOT FINAL part348 Premiere Enterprises MENTHOL .07 g/mL N 20181231 32472-102_cb0c0043-d18c-4e3e-8dcd-f5f12be18683 32472-102 HUMAN OTC DRUG Premieres Pain menthol SPRAY TOPICAL 20110307 OTC MONOGRAPH NOT FINAL part348 Premiere Enterprises MENTHOL 7 g/100mL N 20181231 32472-102_d2f4e94d-703d-45e5-9671-49e07835e6dd 32472-102 HUMAN OTC DRUG Premiere Pain Roll On menthol SPRAY TOPICAL 20110112 OTC MONOGRAPH NOT FINAL part348 Premiere Enterprises MENTHOL 7 g/100mL N 20181231 32819-1001_a60ce300-e959-4adf-8ea4-18291070116e 32819-1001 HUMAN OTC DRUG SimmyungSaengMoSu Hair tonic ALPHA-TOCOPHEROL ACETATE LIQUID TOPICAL 20100902 UNAPPROVED DRUG OTHER Simmyung Pharmaceutical Co Ltd ALPHA-TOCOPHEROL ACETATE; SALICYLIC ACID; NIACINAMIDE 3; .75; .45 mL/150mL; mL/150mL; mL/150mL E 20171231 32909-105_6ef787aa-dbd8-a2a8-583b-d2d2c4f50226 32909-105 HUMAN PRESCRIPTION DRUG Varibar Thin Liquid barium sulfate POWDER, FOR SUSPENSION ORAL 20020801 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE .81 g/g Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-115_17640ef6-fbb6-13cb-900f-3fddb845cf6f 32909-115 HUMAN PRESCRIPTION DRUG Varibar Nectar barium sulfate SUSPENSION ORAL 20170717 NDA NDA208143 E-Z-EM Canada Inc BARIUM SULFATE 400 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-121_60643f91-a8b5-9b4c-1e68-2890ec7a617e 32909-121 HUMAN PRESCRIPTION DRUG Varibar Thin Honey barium sulfate SUSPENSION ORAL 20050501 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 400 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-122_0e1f24ff-78f4-4c60-30c8-f4993a7cf59b 32909-122 HUMAN PRESCRIPTION DRUG Varibar Honey barium sulfate SUSPENSION ORAL 20000601 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 400 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-125_650313bf-9f29-f39a-35fb-3dccc9763895 32909-125 HUMAN PRESCRIPTION DRUG Varibar Pudding Barium Sulfate PASTE ORAL 20161014 NDA NDA208844 E-Z-EM Canada Inc BARIUM SULFATE 400 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-145_83a06a8e-93db-a59b-933c-5882127bce7c 32909-145 HUMAN PRESCRIPTION DRUG ENTERO Vu 24% barium sulfate SUSPENSION ORAL 20000930 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 240 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-168_93c5ced0-697d-c165-e54c-b206bddad499 32909-168 HUMAN PRESCRIPTION DRUG Liquid Polibar Plus Barium Sulfate SUSPENSION ORAL; RECTAL 19840801 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 1.05 g/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-186_668f961b-ac91-7847-ddf4-b07bd72dd8e2 32909-186 HUMAN PRESCRIPTION DRUG E-Z-Paque barium sulfate SUSPENSION ORAL 20170301 NDA NDA208143 E-Z-EM Canada Inc BARIUM SULFATE .6 g/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-540_a9555bc1-355f-40da-b8f8-7705e719901f 32909-540 HUMAN PRESCRIPTION DRUG Gastrografin diatrizoate meglumine and diatrizoate sodium LIQUID ORAL; RECTAL 19580226 NDA NDA011245 E-Z-EM Canada Inc DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM 660; 100 mg/mL; mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-652_96e7b801-f8c0-3a19-22c7-62a196b84128 32909-652 HUMAN PRESCRIPTION DRUG E-Z-Dose with Liquid Polibar Plus Barium Sulfate SUSPENSION RECTAL 19841101 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 1.05 g/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-711_d2d293d5-dcc9-0d3f-58ed-686ef0132d7c 32909-711 HUMAN PRESCRIPTION DRUG Readi-Cat 2 Berry Smoothie Barium Sulfate SUSPENSION ORAL 20170327 NDA NDA208143 E-Z-EM Canada Inc BARIUM SULFATE 20 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-715_0839bf21-23c9-b579-28c9-ba5fccf3cecb 32909-715 HUMAN PRESCRIPTION DRUG Readi-Cat2 Berry Smoothie Barium Sulfate SUSPENSION ORAL 20020201 20181231 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 21 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-717_1c8fb588-e29e-4897-a22f-95e16e9bb6cc 32909-717 HUMAN PRESCRIPTION DRUG E-Z-Cat Dry Barium Sulfate POWDER, FOR SUSPENSION ORAL 20170928 NDA NDA208036 E-Z-EM Canada Inc BARIUM SULFATE 400 mg/g Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-722_d2d293d5-dcc9-0d3f-58ed-686ef0132d7c 32909-722 HUMAN PRESCRIPTION DRUG Readi-Cat 2 Banana Smoothie Barium Sulfate SUSPENSION ORAL 20170327 NDA NDA208143 E-Z-EM Canada Inc BARIUM SULFATE 20 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-723_0839bf21-23c9-b579-28c9-ba5fccf3cecb 32909-723 HUMAN PRESCRIPTION DRUG Readi-Cat2 Barium Sulfate SUSPENSION ORAL 19850601 20181130 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 21 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-724_d2d293d5-dcc9-0d3f-58ed-686ef0132d7c 32909-724 HUMAN PRESCRIPTION DRUG Readi-Cat 2 Barium Sulfate SUSPENSION ORAL 20170327 NDA NDA208143 E-Z-EM Canada Inc BARIUM SULFATE 20 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-725_0839bf21-23c9-b579-28c9-ba5fccf3cecb 32909-725 HUMAN PRESCRIPTION DRUG Readi-Cat2 Banana Smoothie Barium Sulfate SUSPENSION ORAL 19980801 20181130 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 21 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-727_7cc5828d-b9af-c211-011d-7557b8892bd7 32909-727 HUMAN PRESCRIPTION DRUG E-Z-Cat Dry Barium Sulfate POWDER, FOR SUSPENSION ORAL 19960101 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 9.5 g/23g Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-750_b49a6021-89bb-6879-5615-f112e037fcc6 32909-750 HUMAN PRESCRIPTION DRUG E-Z-Paque barium sulfate POWDER, FOR SUSPENSION ORAL 20170601 NDA NDA208036 E-Z-EM Canada Inc BARIUM SULFATE 960 mg/g Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-755_0839bf21-23c9-b579-28c9-ba5fccf3cecb 32909-755 HUMAN PRESCRIPTION DRUG Readi-Cat2 Vanilla Smoothie Barium Sulfate SUSPENSION ORAL 20051101 20181231 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 21 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-756_d2d293d5-dcc9-0d3f-58ed-686ef0132d7c 32909-756 HUMAN PRESCRIPTION DRUG Readi-Cat 2 Creamy Vanilla Smoothie Barium Sulfate SUSPENSION ORAL 20170327 NDA NDA208143 E-Z-EM Canada Inc BARIUM SULFATE 20 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-764_6b8b46a8-33bc-950a-e678-3abf8642ed57 32909-764 HUMAN PRESCRIPTION DRUG E-Z-HD barium sulfate POWDER, FOR SUSPENSION ORAL 20160111 NDA NDA208036 E-Z-EM Canada Inc BARIUM SULFATE 980 mg/g Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-770_704132ea-4986-0b2c-2dd4-de89c0282a15 32909-770 HUMAN PRESCRIPTION DRUG E-Z-Paste Barium Sulfate CREAM ORAL 19740601 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE .6 g/g Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-775_0839bf21-23c9-b579-28c9-ba5fccf3cecb 32909-775 HUMAN PRESCRIPTION DRUG Readi-Cat2 Mochaccino Smoothie Barium Sulfate SUSPENSION ORAL 20090331 20181031 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 21 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-777_d2d293d5-dcc9-0d3f-58ed-686ef0132d7c 32909-777 HUMAN PRESCRIPTION DRUG Readi-Cat 2 Mochaccino Smoothie Barium Sulfate SUSPENSION ORAL 20170327 NDA NDA208143 E-Z-EM Canada Inc BARIUM SULFATE 20 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-804_330cbb50-50ca-4251-b9c7-14e5fa89f7a8 32909-804 HUMAN PRESCRIPTION DRUG Polibar ACB BARIUM SULFATE POWDER, FOR SUSPENSION RECTAL 19780415 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 965 mg/g N 20181231 32909-804_c6f9a216-83b2-f20e-c976-17d1b3713016 32909-804 HUMAN PRESCRIPTION DRUG Polibar ACB Barium Sulfate POWDER, FOR SUSPENSION RECTAL 19780415 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 965 mg/g Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-814_35a20d7b-df95-19c3-1ff7-c0cdd113e60c 32909-814 HUMAN PRESCRIPTION DRUG Tagitol V Barium Sulfate SUSPENSION ORAL 20170804 NDA NDA208143 E-Z-EM Canada Inc BARIUM SULFATE 400 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 32909-945_0edb179d-5b32-3596-a25b-39cf996f8076 32909-945 HUMAN PRESCRIPTION DRUG VoLumen Barium Sulfate SUSPENSION ORAL 20031101 UNAPPROVED DRUG OTHER E-Z-EM Canada Inc BARIUM SULFATE 1 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 33217-001_98d24085-4d2d-403c-8d95-2150472774a2 33217-001 HUMAN OTC DRUG CHING WAN HUNG SOOTHING HERBAL BALM MENTHOL OINTMENT TOPICAL 20120812 OTC MONOGRAPH NOT FINAL part348 TIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL CO., LTD. MENTHOL 1 g/100g N 20181231 33237-001_b4c2834f-1963-40af-96d1-ab27840185b5 33237-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070401 NDA NDA205840 Airgas Merchant Gases, LLC OXYGEN 990 mL/L N 20181231 33237-002_d594c5cf-03ae-46e8-b89e-60975cfa6235 33237-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20070401 NDA NDA205839 Airgas Merchant Gases, LLC NITROGEN 990 mL/L N 20181231 33261-001_52b8a439-688c-43db-bfea-a773b81a2157 33261-001 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Aidarex Pharmaceuticals LLC CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 33261-002_52b8a439-688c-43db-bfea-a773b81a2157 33261-002 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089828 Aidarex Pharmaceuticals LLC CODEINE PHOSPHATE; ACETAMINOPHEN 60; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 33261-003_feac2096-3a09-478f-9c0d-349eb3707e57 33261-003 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 Aidarex Pharmaceuticals LLC ACETAMINOPHEN 500 mg/1 N 20181231 33261-004_93729350-108f-4474-811d-9e4ca0294eac 33261-004 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Aidarex Pharmaceuticals LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 33261-005_93729350-108f-4474-811d-9e4ca0294eac 33261-005 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Aidarex Pharmaceuticals LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 33261-007_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-007 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 33261-010_c3489764-d9f9-4d2a-ab7f-3c3bfa652af7 33261-010 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077156 Aidarex Pharmaceuticals LLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 33261-011_c3489764-d9f9-4d2a-ab7f-3c3bfa652af7 33261-011 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077068 Aidarex Pharmaceuticals LLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 33261-012_b5db0a4b-286e-42a7-accc-70fc84efeaa7 33261-012 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 33261-013_b5db0a4b-286e-42a7-accc-70fc84efeaa7 33261-013 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 33261-014_33365e8c-5579-4254-aac1-04601d46cec7 33261-014 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 Aidarex Pharmaceuticals LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 33261-015_33365e8c-5579-4254-aac1-04601d46cec7 33261-015 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075022 Aidarex Pharmaceuticals LLC BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 33261-018_6b12226c-28cd-4448-9b95-242fd0cc761e 33261-018 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080423 ANDA ANDA065392 Aidarex Pharmaceuticals LLC CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 33261-019_bcb89362-3e1a-41ed-ba17-d740662897e0 33261-019 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Aidarex Pharmaceuticals LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-020_9e4f9fd2-cd74-4527-8b28-4688f72cdf6f 33261-020 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Aidarex Pharmaceuticals LLC CEPHALEXIN ANHYDROUS 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 33261-021_a9dbb759-844a-4b12-9fe5-c08c041c49b6 33261-021 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 Aidarex Pharmaceuticals LLC CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 33261-024_d122e35a-08d1-441b-8a9d-b9b99ddcab9e 33261-024 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20040202 ANDA ANDA074151 Aidarex Pharmaceuticals LLC CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 33261-026_11d5faa0-145f-45b8-a386-b17d0ef240d0 33261-026 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Aidarex Pharmaceuticals LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-027_11d5faa0-145f-45b8-a386-b17d0ef240d0 33261-027 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Aidarex Pharmaceuticals LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-028_11d5faa0-145f-45b8-a386-b17d0ef240d0 33261-028 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Aidarex Pharmaceuticals LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-029_8fa29043-847f-4835-b929-70ac0e139880 33261-029 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Aidarex Pharmaceuticals LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 33261-033_1b891b2e-c23a-44cf-8d4e-4d26dd070023 33261-033 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 Aidarex Pharmaceuticals LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 33261-034_1288f851-da84-40fb-9b2c-d50c826fe791 33261-034 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Aidarex Pharmaceuticals LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 33261-035_1288f851-da84-40fb-9b2c-d50c826fe791 33261-035 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Aidarex Pharmaceuticals LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 33261-038_86cb1755-1ee1-46a2-8db0-4c573a5dbc9f 33261-038 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19980811 ANDA ANDA075219 Aidarex Pharmaceuticals LLC DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-039_67a1c308-26ed-4150-8e1e-21c9d07d220f 33261-039 HUMAN OTC DRUG Non-Habit Forming Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Aidarex Pharmaceuticals LLC DOCUSATE SODIUM 100 mg/1 N 20181231 33261-043_f67ac41b-c0aa-4443-8468-fc7e2f975da7 33261-043 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 Aidarex Pharmaceuticals LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-044_f67ac41b-c0aa-4443-8468-fc7e2f975da7 33261-044 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20090909 ANDA ANDA075009 Aidarex Pharmaceuticals LLC ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-045_ca0dc511-15a7-4911-a012-ad975bfc34d3 33261-045 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Aidarex Pharmaceuticals LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-048_aeb1540b-a797-44b1-9964-28ddfba18b4f 33261-048 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Aidarex Pharmaceuticals LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 33261-049_aeb1540b-a797-44b1-9964-28ddfba18b4f 33261-049 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Aidarex Pharmaceuticals LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 33261-050_aeb1540b-a797-44b1-9964-28ddfba18b4f 33261-050 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Aidarex Pharmaceuticals LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 33261-051_0756b645-0741-4473-b777-7ee472358140 33261-051 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 Aidarex Pharmaceuticals LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 33261-053_8f98cf9d-4986-42da-8120-3cf9347a0aa3 33261-053 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Aidarex Pharmaceuticals LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 33261-055_8f98cf9d-4986-42da-8120-3cf9347a0aa3 33261-055 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Aidarex Pharmaceuticals LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 33261-058_8f98cf9d-4986-42da-8120-3cf9347a0aa3 33261-058 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Aidarex Pharmaceuticals LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 33261-060_06f5fb33-7f65-4bc8-bbaf-be11626de267 33261-060 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19940816 ANDA ANDA072096 Aidarex Pharmaceuticals LLC IBUPROFEN 200 mg/1 N 20181231 33261-061_f3c660d7-4795-4f28-bc87-7a97a6b3c256 33261-061 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Aidarex Pharmaceuticals LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-062_f3c660d7-4795-4f28-bc87-7a97a6b3c256 33261-062 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Aidarex Pharmaceuticals LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-064_db694f6b-8c95-4f66-9b6e-5ab64d416abe 33261-064 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073517 Aidarex Pharmaceuticals LLC KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-065_5a527655-75fd-42b8-b724-ff24d527a240 33261-065 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 Aidarex Pharmaceuticals LLC KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 33261-068_42ce3852-92b2-4637-89cf-a85b2e106ccf 33261-068 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Aidarex Pharmaceuticals LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 33261-069_42ce3852-92b2-4637-89cf-a85b2e106ccf 33261-069 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Aidarex Pharmaceuticals LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 33261-070_c077af4d-7cae-43da-8004-768284bda2dd 33261-070 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Aidarex Pharmaceuticals LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-071_c077af4d-7cae-43da-8004-768284bda2dd 33261-071 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Aidarex Pharmaceuticals LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-072_db596a36-5f82-4d41-a563-e583eb355e56 33261-072 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Aidarex Pharmaceuticals LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 33261-073_c25beec4-de6c-4516-a172-f7408248831a 33261-073 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aidarex Pharmaceuticals LLC MIRTAZAPINE 15 mg/1 N 20181231 33261-074_96a2c79d-af3b-44d6-8894-7483dc3e2139 33261-074 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Aidarex Pharmaceuticals LLC MIRTAZAPINE 30 mg/1 N 20181231 33261-076_384c955d-a727-43b5-be9e-3e6f501cf2d3 33261-076 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 Aidarex Pharmaceuticals LLC MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 33261-077_856e729d-1c5e-40d8-96e6-90b1e3cf43c9 33261-077 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 Aidarex Pharmaceuticals LLC NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-078_b3102c1a-a63f-480c-9391-99669c295f7f 33261-078 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Aidarex Pharmaceuticals LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-079_8ec413d7-65e0-4019-a2bc-7b8ebb2e7824 33261-079 HUMAN OTC DRUG good sense all day pain relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Aidarex Pharmaceuticals LLC NAPROXEN SODIUM 220 mg/1 N 20181231 33261-080_7e3dcdf1-4ba5-458d-b4e1-20ab4e9dda2b 33261-080 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aidarex Pharmaceuticals LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-081_4ac8c61d-66f2-49f0-959f-7f2a92137a61 33261-081 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aidarex Pharmaceuticals LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-082_c4e5a877-72fc-4cd7-9492-905e8df337d8 33261-082 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980731 ANDA ANDA075227 Aidarex Pharmaceuticals LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-083_c4e5a877-72fc-4cd7-9492-905e8df337d8 33261-083 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980729 ANDA ANDA075227 Aidarex Pharmaceuticals LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-084_f67ff8f9-fff1-4cd4-abc6-819b577837dc 33261-084 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Aidarex Pharmaceuticals LLC NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-085_f67ff8f9-fff1-4cd4-abc6-819b577837dc 33261-085 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Aidarex Pharmaceuticals LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-087_884283f6-ff17-45e2-8452-731609251271 33261-087 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Aidarex Pharmaceuticals LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 33261-088_2076f538-fb8b-4bbb-aaff-c50a32e92d07 33261-088 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Aidarex Pharmaceuticals LLC ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 33261-090_847c3a3f-7716-462c-a7f3-481e3501876b 33261-090 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Aidarex Pharmaceuticals LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-091_847c3a3f-7716-462c-a7f3-481e3501876b 33261-091 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Aidarex Pharmaceuticals LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-099_99a8f78f-d074-4c2a-8dff-b0637b2a2324 33261-099 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Aidarex Pharmaceuticals LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 33261-100_3aa87574-73f6-487c-9e06-6f5b348b38dc 33261-100 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20100125 ANDA ANDA072711 Aidarex Pharmaceuticals LLC SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-103_9b79e6bb-62f1-473c-ac30-3dba1a23384d 33261-103 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Aidarex Pharmaceuticals LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 33261-104_9b79e6bb-62f1-473c-ac30-3dba1a23384d 33261-104 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Aidarex Pharmaceuticals LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 33261-105_1dcbca44-a8e9-47a2-8c61-2758dd586a83 33261-105 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Aidarex Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 33261-106_e1c475c2-3437-4249-af16-1f9142ff1941 33261-106 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Aidarex Pharmaceuticals LLC TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 33261-107_ed1631ee-9ac0-4936-9749-e6be6ef1aa44 33261-107 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Aidarex Pharmaceuticals LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 33261-109_0a6cb56c-0b44-45d8-8538-ca16e678ab9b 33261-109 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Aidarex Pharmaceuticals LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-110_e65cb52f-902e-46f2-bf7c-05aa73ef281e 33261-110 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Aidarex Pharmaceuticals LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-111_6c362672-6199-4377-a903-2eb110e836fb 33261-111 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 33261-112_6c362672-6199-4377-a903-2eb110e836fb 33261-112 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 33261-116_0756b645-0741-4473-b777-7ee472358140 33261-116 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 Aidarex Pharmaceuticals LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 33261-117_884283f6-ff17-45e2-8452-731609251271 33261-117 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Aidarex Pharmaceuticals LLC OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 33261-128_4ac8c61d-66f2-49f0-959f-7f2a92137a61 33261-128 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aidarex Pharmaceuticals LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-129_3c78a73d-80ef-4a71-8aeb-a101196947e6 33261-129 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 Aidarex Pharmaceuticals LLC PREDNISONE 20 mg/1 N 20181231 33261-130_db596a36-5f82-4d41-a563-e583eb355e56 33261-130 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Aidarex Pharmaceuticals LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 33261-131_e06b299b-b1b6-40db-94b3-30d476196771 33261-131 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20120717 ANDA ANDA040712 Aidarex Pharmaceuticals LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 33261-132_145b4e74-3442-4d9c-81b7-f71fe7401332 33261-132 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 33261-134_65666c2b-4095-4d95-b941-e5ef4956474c 33261-134 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062936 Aidarex Pharmaceuticals LLC PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 33261-137_d4fa5d57-edb5-4dc5-94a0-5cd9bddc9dcd 33261-137 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 Aidarex Pharmaceuticals LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 33261-138_65666c2b-4095-4d95-b941-e5ef4956474c 33261-138 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 Aidarex Pharmaceuticals LLC PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 33261-141_b6201f98-9bd5-4cde-87b6-750478ff74ae 33261-141 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 19980301 ANDA ANDA040268 Aidarex Pharmaceuticals LLC PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 33261-142_186f6ced-01db-464f-99a5-31d586c6fb91 33261-142 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20110421 OTC MONOGRAPH NOT FINAL part343 Aidarex Pharmaceuticals LLC ACETAMINOPHEN 325 mg/1 N 20181231 33261-143_d2bb7fc7-fb5c-4aee-b764-58cbe04933db 33261-143 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 Aidarex Pharmaceuticals LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 33261-144_d4fa5d57-edb5-4dc5-94a0-5cd9bddc9dcd 33261-144 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 Aidarex Pharmaceuticals LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 33261-145_01865cdb-07be-4125-8bd9-6e4c61f5f0f8 33261-145 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Aidarex Pharmaceuticals LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 33261-146_08efe152-6ce2-477a-9b41-0b3fe7abb8eb 33261-146 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19981001 ANDA ANDA075034 Aidarex Pharmaceuticals LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 33261-147_5e2ff1d2-363a-41a0-b6ac-8ced16c6fb7b 33261-147 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Aidarex Pharmaceuticals LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 33261-148_927a9937-2723-496c-ad8d-5b4ddcad446c 33261-148 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Aidarex Pharmaceuticals LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 33261-149_9e4f9fd2-cd74-4527-8b28-4688f72cdf6f 33261-149 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Aidarex Pharmaceuticals LLC CEPHALEXIN ANHYDROUS 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 33261-150_145b4e74-3442-4d9c-81b7-f71fe7401332 33261-150 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 33261-151_72aa6c88-0bac-469c-a1d8-4433c4f926b2 33261-151 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840507 ANDA ANDA062396 Aidarex Pharmaceuticals LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 33261-152_896b0412-3ac7-470f-b96c-b3a6b50cf6a1 33261-152 HUMAN OTC DRUG Adult Low Dose Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20070112 OTC MONOGRAPH FINAL part343 Aidarex Pharmaceuticals LLC ASPIRIN 81 mg/1 N 20181231 33261-153_0d38a94d-5641-4615-96ee-28363bda0515 33261-153 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 Aidarex Pharmaceuticals LLC ASPIRIN 325 mg/1 N 20181231 33261-155_f3c660d7-4795-4f28-bc87-7a97a6b3c256 33261-155 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Aidarex Pharmaceuticals LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33261-157_14425971-c3fa-42df-b5bc-f2406863729b 33261-157 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Aidarex Pharmaceuticals LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 33261-158_be013517-42af-4118-8ae1-b35b8ea34684 33261-158 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33261-159_8eb8b8e7-e935-4074-8a7a-d1e9116fd6f6 33261-159 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Aidarex Pharmaceuticals LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 33261-160_287b7aba-b3e7-4a98-ac8b-474f17157b0e 33261-160 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Aidarex Pharmaceuticals LLC NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 33261-161_378b331a-5db3-40e2-b671-84528f371c2c 33261-161 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 Aidarex Pharmaceuticals LLC HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 33261-163_265be229-6d0b-4ceb-a94a-7f84ca2c3141 33261-163 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19990226 ANDA ANDA040230 Aidarex Pharmaceuticals LLC DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 33261-164_da202d5d-414e-42a2-8a90-e20c90b0afec 33261-164 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Aidarex Pharmaceuticals LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 33261-166_9f5ed975-8bb7-4b71-af13-292cbd830a24 33261-166 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Aidarex Pharmaceuticals LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 33261-167_7fb1334a-5e01-4002-8541-7dd4a3279fa8 33261-167 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 Aidarex Pharmaceuticals LLC DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 33261-170_2e6b8fbe-b434-4564-9587-c81e3a758345 33261-170 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Aidarex Pharmaceuticals LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-171_2e6b8fbe-b434-4564-9587-c81e3a758345 33261-171 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Aidarex Pharmaceuticals LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-172_a1bad093-8e73-403e-a4b7-f7fede4451d9 33261-172 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Aidarex Pharmaceuticals LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 33261-173_a1bad093-8e73-403e-a4b7-f7fede4451d9 33261-173 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Aidarex Pharmaceuticals LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 33261-174_8e5a1b85-9468-4dc3-94b8-06cda657d5b3 33261-174 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Aidarex Pharmaceuticals LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 33261-178_78f88be7-cf2a-457c-b2ab-3a9144283384 33261-178 HUMAN OTC DRUG Enteric Coated Stimulant Laxative Bisacodyl TABLET, DELAYED RELEASE ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Aidarex Pharmaceuticals LLC BISACODYL 5 mg/1 N 20181231 33261-179_2e92a75c-ab99-49b1-8033-efbbcace2d68 33261-179 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Aidarex Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 33261-180_2e92a75c-ab99-49b1-8033-efbbcace2d68 33261-180 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Aidarex Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 33261-182_b01ba900-3657-4093-875f-11c5140561a3 33261-182 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Aidarex Pharmaceuticals LLC CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-183_8b3d55d1-6227-4214-8b25-fa39a072fcc7 33261-183 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Aidarex Pharmaceuticals LLC DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 33261-184_cc89478b-92bc-405d-b618-06906a2e7359 33261-184 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Aidarex Pharmaceuticals LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-185_3a7c6910-e16c-4c50-8028-4f58aca0010b 33261-185 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Aidarex Pharmaceuticals LLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 33261-196_93f3b84a-320d-47d8-ab87-36a51d8da190 33261-196 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20160309 ANDA ANDA202677 Aidarex Pharmaceuticals LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 33261-202_99a8f78f-d074-4c2a-8dff-b0637b2a2324 33261-202 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Aidarex Pharmaceuticals LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 33261-209_fea6f761-235f-4d3d-99c6-6389070ec7d9 33261-209 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Aidarex Pharmaceuticals LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 33261-211_ce7c1472-b399-493e-a419-e71701b04acc 33261-211 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20010412 ANDA ANDA075498 Aidarex Pharmaceuticals LLC TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 33261-212_ce7c1472-b399-493e-a419-e71701b04acc 33261-212 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20010412 ANDA ANDA075498 Aidarex Pharmaceuticals LLC TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 33261-215_2db171f2-8e66-4b37-a0d4-ce781a9f87f7 33261-215 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Aidarex Pharmaceuticals LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 33261-220_e821edd9-cd2c-4f50-92a2-ab13a5823e86 33261-220 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Aidarex Pharmaceuticals LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 33261-222_41a6f20f-8d1b-4f11-9618-d6b70ef073d9 33261-222 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Aidarex Pharmaceuticals LLC CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 33261-224_99e2903e-bc3a-4829-ac6b-f78731ee704f 33261-224 HUMAN OTC DRUG Mi-Acid Gas Relief Simethicone TABLET, CHEWABLE ORAL 20110302 OTC MONOGRAPH FINAL part332 Aidarex Pharmaceuticals LLC DIMETHICONE 80 mg/1 N 20181231 33261-226_9d53dbae-d850-4c5b-b602-365135ceb487 33261-226 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Aidarex Pharmaceuticals LLC NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 33261-227_7a30fb41-2a84-4afb-a155-46dba2cfb76a 33261-227 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970430 ANDA ANDA074556 Aidarex Pharmaceuticals LLC ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 33261-228_733d75a7-5111-47b2-a8c2-879fca5993c6 33261-228 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 Aidarex Pharmaceuticals LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 33261-229_47349194-fbe8-4176-86f2-67454764c301 33261-229 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 Aidarex Pharmaceuticals LLC FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 33261-332_0a6cb56c-0b44-45d8-8538-ca16e678ab9b 33261-332 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Aidarex Pharmaceuticals LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-335_09135c69-fdaa-4452-a8d4-81cff1a36ceb 33261-335 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 Aidarex Pharmaceuticals LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 33261-336_dc4501f9-c70f-46c1-811b-d72fdc4af22c 33261-336 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Aidarex Pharmaceuticals LLC PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 33261-337_44cce19f-c8c1-4ec3-bc37-7d90521f0d99 33261-337 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Aidarex Pharmaceuticals LLC LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 33261-340_8fa29043-847f-4835-b929-70ac0e139880 33261-340 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Aidarex Pharmaceuticals LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 33261-341_2ab0e38c-de77-4f37-a0c5-c99aac1aac78 33261-341 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 Aidarex Pharmaceuticals LLC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 33261-342_3f4d9011-13a0-4ec4-a343-75ff90e9782f 33261-342 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 Aidarex Pharmaceuticals LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 33261-344_c11a6272-a3e1-4962-83ca-17bdb3e966c5 33261-344 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 Aidarex Pharmaceuticals LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 33261-346_c6cd640f-0dd1-4c1c-bd96-6d1aa77a0c63 33261-346 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Aidarex Pharmaceuticals LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-348_7f8fad0a-267b-4284-9de3-14ddd77d9ac0 33261-348 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950406 ANDA ANDA074132 Aidarex Pharmaceuticals LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 33261-349_e821edd9-cd2c-4f50-92a2-ab13a5823e86 33261-349 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Aidarex Pharmaceuticals LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 33261-351_3c78a73d-80ef-4a71-8aeb-a101196947e6 33261-351 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Aidarex Pharmaceuticals LLC PREDNISONE 5 mg/1 N 20181231 33261-352_3c78a73d-80ef-4a71-8aeb-a101196947e6 33261-352 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Aidarex Pharmaceuticals LLC PREDNISONE 10 mg/1 N 20181231 33261-353_9af69fd4-964e-4666-88da-0bc5697e11c1 33261-353 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TABLET ORAL 20101227 ANDA ANDA201212 Aidarex Pharmaceuticals LLC DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 33261-354_55fa3e3c-536a-4fba-8006-86f392a23ce7 33261-354 HUMAN PRESCRIPTION DRUG Diethylpropion HydrochlorideER ER Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111024 ANDA ANDA091680 Aidarex Pharmaceuticals LLC DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 33261-355_fffb5cb3-6568-4027-80b4-8bd01a4769ce 33261-355 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 33261-356_fffb5cb3-6568-4027-80b4-8bd01a4769ce 33261-356 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 33261-357_fffb5cb3-6568-4027-80b4-8bd01a4769ce 33261-357 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 33261-358_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-358 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 33261-361_5f577a31-f2d5-4439-88be-f3cac906776c 33261-361 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Aidarex Pharmaceuticals LLC PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 33261-363_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-363 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 33261-364_42ce3852-92b2-4637-89cf-a85b2e106ccf 33261-364 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Aidarex Pharmaceuticals LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 33261-365_d4fa43fb-d4d3-4a6a-a66e-0b8d02bee478 33261-365 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA071851 Aidarex Pharmaceuticals LLC TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33261-366_5f577a31-f2d5-4439-88be-f3cac906776c 33261-366 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 Aidarex Pharmaceuticals LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 33261-367_da202d5d-414e-42a2-8a90-e20c90b0afec 33261-367 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Aidarex Pharmaceuticals LLC CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 33261-372_7051a1a4-226c-4a41-b5d3-0f666740855b 33261-372 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 Aidarex Pharmaceuticals LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 33261-373_2cddca79-12fd-478f-a173-9f43803be9e1 33261-373 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Aidarex Pharmaceuticals LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-374_8e5a1b85-9468-4dc3-94b8-06cda657d5b3 33261-374 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Aidarex Pharmaceuticals LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 33261-376_2c5e9aab-f400-47be-ab36-e1b3f055f249 33261-376 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 Aidarex Pharmaceuticals LLC POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 33261-378_f16db661-9faa-4340-84f9-acf1497b5d15 33261-378 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED ORAL 20040401 ANDA ANDA076604 Aidarex Pharmaceuticals LLC HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII N 20181231 33261-384_351fe213-7c9c-4d7e-a68e-3d6b84c663ca 33261-384 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070044 Aidarex Pharmaceuticals LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 33261-385_ed1631ee-9ac0-4936-9749-e6be6ef1aa44 33261-385 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 Aidarex Pharmaceuticals LLC TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 33261-386_ed1631ee-9ac0-4936-9749-e6be6ef1aa44 33261-386 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Aidarex Pharmaceuticals LLC TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 33261-387_8b551ae6-9f3a-4ff2-b62d-e74d5e6fe9a0 33261-387 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20100830 ANDA ANDA040124 Aidarex Pharmaceuticals LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 33261-389_055f642c-a10c-4209-812b-d9f3c1a7816e 33261-389 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Aidarex Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 33261-390_a815119a-0cf9-4dfd-9c17-aa9af6e52585 33261-390 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 Aidarex Pharmaceuticals LLC PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 33261-391_bbb202cc-8929-4ad4-bb03-3737038a6e4e 33261-391 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20060131 ANDA ANDA040650 Aidarex Pharmaceuticals LLC PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 33261-393_18da72cf-bc71-46c3-a184-f99740bf8d7d 33261-393 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Aidarex Pharmaceuticals LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 33261-396_a3ab3a35-a130-4804-9ad8-0d733c7a8d48 33261-396 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100225 ANDA ANDA076899 Aidarex Pharmaceuticals LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 33261-397_c5e4b51a-8b09-4030-8221-7de9183d4110 33261-397 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 Aidarex Pharmaceuticals LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 33261-399_da202d5d-414e-42a2-8a90-e20c90b0afec 33261-399 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Aidarex Pharmaceuticals LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 33261-400_bb2afcb1-4412-4841-a449-7feff8f10da0 33261-400 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Aidarex Pharmaceuticals LLC TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 33261-403_335dec43-2c8b-4432-81e1-f9284a7a834f 33261-403 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Aidarex Pharmaceuticals LLC AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 33261-408_de1b0250-3018-48a3-a7f3-49639679a086 33261-408 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120815 ANDA ANDA040887 Aidarex Pharmaceuticals LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 33261-413_433935fb-4377-4c68-9fd8-b127bf281095 33261-413 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20080722 OTC MONOGRAPH FINAL part336 Aidarex Pharmaceuticals LLC MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 33261-416_76932243-b0df-474c-aa58-b41c89d051d7 33261-416 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-417_1156d9cb-4ad2-49c0-b7ee-4b947c5dcc84 33261-417 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Aidarex Pharmaceuticals LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 33261-419_7a30fb41-2a84-4afb-a155-46dba2cfb76a 33261-419 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970423 ANDA ANDA074578 Aidarex Pharmaceuticals LLC ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 33261-433_c5e4b51a-8b09-4030-8221-7de9183d4110 33261-433 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 Aidarex Pharmaceuticals LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 33261-434_b467b2f6-9ecd-45be-a714-664764233d01 33261-434 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Aidarex Pharmaceuticals LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 33261-437_0d247451-52f8-45ba-a1ec-91401605c8d0 33261-437 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 33261-441_69e110c7-961b-433f-ab96-cd1c4c739c78 33261-441 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Aidarex Pharmaceuticals LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 33261-448_8eb8b8e7-e935-4074-8a7a-d1e9116fd6f6 33261-448 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Aidarex Pharmaceuticals LLC CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 33261-449_06831b0d-ae6e-45d0-bd17-955ab16c31d3 33261-449 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120515 ANDA ANDA201331 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 33261-454_102c0c6c-be48-40e6-8299-031e8f3dc843 33261-454 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Aidarex Pharmaceuticals LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 33261-458_9f37c87d-020c-4e5c-b3b9-dfae7d38ae62 33261-458 HUMAN PRESCRIPTION DRUG BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET ORAL 20100721 ANDA ANDA090968 Aidarex Pharmaceuticals LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 33261-459_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-459 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 33261-460_02811f2f-f4d1-44c0-9ba3-f8dcba5c3cf3 33261-460 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Aidarex Pharmaceuticals LLC AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 33261-463_12a87643-479a-4a6c-b307-646c58aa89f6 33261-463 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Aidarex Pharmaceuticals LLC AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 33261-464_7ba622bc-fa2c-4ed8-a06d-c545253f39f5 33261-464 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 33261-470_86859de8-6f89-477b-8e5a-c9634bb99693 33261-470 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEINE PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA087508 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 33261-471_de1b0250-3018-48a3-a7f3-49639679a086 33261-471 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040876 Aidarex Pharmaceuticals LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 33261-475_168364de-3c99-4692-8485-c0a196d3ce18 33261-475 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 19981211 ANDA ANDA089081 Aidarex Pharmaceuticals LLC PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 33261-480_bb2afcb1-4412-4841-a449-7feff8f10da0 33261-480 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Aidarex Pharmaceuticals LLC TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 33261-483_5e9ad922-f27b-413e-9b11-a1a649e4c695 33261-483 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 Aidarex Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 33261-485_9caae802-6283-4387-95dd-82aa5542a22d 33261-485 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20060111 ANDA ANDA065234 Aidarex Pharmaceuticals LLC CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 33261-486_102c0c6c-be48-40e6-8299-031e8f3dc843 33261-486 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Aidarex Pharmaceuticals LLC ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 33261-487_d623665e-8c16-4726-a5ea-69427c124f03 33261-487 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Aidarex Pharmaceuticals LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 33261-488_9abd651c-3fc9-4426-9392-6e2a783d3d8e 33261-488 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Aidarex Pharmaceuticals LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 33261-491_7a30fb41-2a84-4afb-a155-46dba2cfb76a 33261-491 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 Aidarex Pharmaceuticals LLC ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 33261-495_f0ecf791-3c3e-4d4d-8ab8-57d2afc63f0a 33261-495 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 Aidarex Pharmaceuticals LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 33261-500_93729350-108f-4474-811d-9e4ca0294eac 33261-500 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Aidarex Pharmaceuticals LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 33261-517_e821edd9-cd2c-4f50-92a2-ab13a5823e86 33261-517 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Aidarex Pharmaceuticals LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 33261-520_60ad2cb3-c0b0-4bc6-be97-bc62cb405d1e 33261-520 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20050428 ANDA ANDA088799 Aidarex Pharmaceuticals LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 33261-532_fed33441-965f-40ad-af22-e32244a884cd 33261-532 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073553 Aidarex Pharmaceuticals LLC NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 33261-534_625f2552-b7bf-4ee3-a58e-9e22578f2280 33261-534 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Aidarex Pharmaceuticals LLC MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 33261-535_0d247451-52f8-45ba-a1ec-91401605c8d0 33261-535 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 33261-536_b01ba900-3657-4093-875f-11c5140561a3 33261-536 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Aidarex Pharmaceuticals LLC CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-537_381aa246-233f-490b-80cb-91fef3b7bf56 33261-537 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Aidarex Pharmaceuticals LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 33261-541_733c33c5-9968-4f49-9f73-2aab91932134 33261-541 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Aidarex Pharmaceuticals LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 33261-542_733c33c5-9968-4f49-9f73-2aab91932134 33261-542 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Aidarex Pharmaceuticals LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 33261-545_1615bea2-4bef-460c-9bde-65b19531f000 33261-545 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 Aidarex Pharmaceuticals LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 33261-546_733c33c5-9968-4f49-9f73-2aab91932134 33261-546 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Aidarex Pharmaceuticals LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 33261-547_397bf662-ca3a-44ce-a21f-745cf71e15de 33261-547 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Aidarex Pharmaceuticals LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 33261-548_397bf662-ca3a-44ce-a21f-745cf71e15de 33261-548 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Aidarex Pharmaceuticals LLC LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 33261-549_397bf662-ca3a-44ce-a21f-745cf71e15de 33261-549 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Aidarex Pharmaceuticals LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 33261-550_b6201f98-9bd5-4cde-87b6-750478ff74ae 33261-550 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 19980301 ANDA ANDA040268 Aidarex Pharmaceuticals LLC PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 33261-554_533f028c-bba8-491b-9860-bd45f27d352b 33261-554 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Aidarex Pharmaceuticals LLC ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 33261-562_316b2807-6d53-4d3d-9346-064bccd2fd60 33261-562 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Aidarex Pharmaceuticals LLC FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 33261-564_3ad10c0b-4d0f-44dd-a9ca-9ed8289d52ef 33261-564 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 19720630 ANDA ANDA080198 Aidarex Pharmaceuticals LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 33261-591_23d5e33c-26ef-43a2-a88f-5b601eeb126d 33261-591 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20030925 ANDA ANDA076290 Aidarex Pharmaceuticals LLC LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 33261-594_93729350-108f-4474-811d-9e4ca0294eac 33261-594 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Aidarex Pharmaceuticals LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 33261-597_294053a9-959b-49d5-a4e7-f0e4e2061e4e 33261-597 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018877 Aidarex Pharmaceuticals LLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 33261-600_7f5fefc0-1979-45a2-966c-616ca2ccfa7f 33261-600 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20010622 NDA NDA050755 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 33261-602_1135c0be-16b1-4427-aaa6-bd81d53ed2fb 33261-602 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Aidarex Pharmaceuticals LLC AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 33261-604_2323a0e0-63f8-4083-bda3-2f65f374fd40 33261-604 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 19980105 ANDA ANDA062452 Aidarex Pharmaceuticals LLC GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 33261-609_625f2552-b7bf-4ee3-a58e-9e22578f2280 33261-609 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Aidarex Pharmaceuticals LLC MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 33261-618_c32a755e-ce62-4ae6-a581-e1f2f26e65ed 33261-618 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Aidarex Pharmaceuticals LLC CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 33261-621_38af301a-ce6f-4d9e-b36a-a20cd38b8618 33261-621 HUMAN PRESCRIPTION DRUG Divalproex SodiumDelayed-Release Delayed-Release Divalproex Sodium TABLET, FILM COATED ORAL 20091130 ANDA ANDA090210 Aidarex Pharmaceuticals LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 33261-623_1db86484-b07f-4b68-85f0-547d7e723183 33261-623 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Aidarex Pharmaceuticals LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 33261-625_cb55bd60-89dd-4231-a2da-2694ed2973fb 33261-625 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088238 Aidarex Pharmaceuticals LLC DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 33261-626_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-626 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 33261-627_9e647b64-0405-4e32-97bd-0edb09854911 33261-627 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 33261-628_8fa29043-847f-4835-b929-70ac0e139880 33261-628 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Aidarex Pharmaceuticals LLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 33261-631_c32a755e-ce62-4ae6-a581-e1f2f26e65ed 33261-631 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Aidarex Pharmaceuticals LLC CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 33261-634_5e2ff1d2-363a-41a0-b6ac-8ced16c6fb7b 33261-634 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Aidarex Pharmaceuticals LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 33261-641_c587a83e-6bd2-4645-8044-0884fbb2bc4f 33261-641 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Aidarex Pharmaceuticals LLC DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 33261-642_dc4501f9-c70f-46c1-811b-d72fdc4af22c 33261-642 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Aidarex Pharmaceuticals LLC PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 33261-643_dc4501f9-c70f-46c1-811b-d72fdc4af22c 33261-643 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Aidarex Pharmaceuticals LLC PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 33261-644_1e7747a9-6c6e-4026-8be6-5963db67ed61 33261-644 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Aidarex Pharmaceuticals LLC LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 33261-645_1e7747a9-6c6e-4026-8be6-5963db67ed61 33261-645 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Aidarex Pharmaceuticals LLC LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 33261-646_1e7747a9-6c6e-4026-8be6-5963db67ed61 33261-646 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Aidarex Pharmaceuticals LLC LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 33261-647_d62710fe-d3d0-4714-b3bb-e1f6dd916946 33261-647 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Aidarex Pharmaceuticals LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 33261-648_3ccfd582-29b5-4ea0-8f3b-2bd4fca4ace0 33261-648 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 Aidarex Pharmaceuticals LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 33261-651_4733ab54-e3cd-4989-873f-0bba590b2a26 33261-651 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 Aidarex Pharmaceuticals LLC PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 N 20181231 33261-658_8828c164-2572-4b0e-8228-d86a9ca630d0 33261-658 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20111027 ANDA ANDA075509 Aidarex Pharmaceuticals LLC DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 33261-663_c7b7632b-aaaa-41d3-9b3f-dd59e0d4c0e3 33261-663 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aidarex Pharmaceuticals LLC SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 33261-665_8fa5d478-4b57-48f2-80ef-746f8f8953b6 33261-665 HUMAN OTC DRUG Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Aidarex Pharmaceuticals LLC ACETAMINOPHEN 650 mg/1 N 20181231 33261-667_81b5ab1e-b277-43ac-9a7b-d14d60457c12 33261-667 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Aidarex Pharmaceuticals LLC ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 33261-671_fe75c6ea-95b8-41a5-b92d-0332b75d1d38 33261-671 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET ORAL 20140801 ANDA ANDA204476 Aidarex Pharmaceuticals LLC PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] N 20181231 33261-674_39a3e584-a805-427d-8f53-44c2ad215b2f 33261-674 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 Aidarex Pharmaceuticals LLC LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 33261-676_2b8c4ae6-ba9f-43d3-93d1-e731b10a0a4d 33261-676 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 Aidarex Pharmaceuticals LLC CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 33261-677_e4ca368f-2ead-4dd5-bdfb-53644b99e8c9 33261-677 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-679_e4ca368f-2ead-4dd5-bdfb-53644b99e8c9 33261-679 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-680_9e647b64-0405-4e32-97bd-0edb09854911 33261-680 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081125 ANDA ANDA077284 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 33261-683_c52564a5-732a-4f66-803b-4a3d55d53306 33261-683 HUMAN PRESCRIPTION DRUG fluvoxamine maleate Fluvoxamine maleate TABLET, COATED ORAL 20110809 NDA AUTHORIZED GENERIC NDA021519 Aidarex Pharmaceuticals LLC FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-684_c432adf9-17a7-4c67-8488-0c67c6185103 33261-684 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Aidarex Pharmaceuticals LLC OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 33261-685_f88e1600-0e18-433a-90ae-1dcc7817bb59 33261-685 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 Aidarex Pharmaceuticals LLC DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 33261-686_d73d3c7c-5e0c-43b7-992c-105eb90c7103 33261-686 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Aidarex Pharmaceuticals LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-692_7f8fad0a-267b-4284-9de3-14ddd77d9ac0 33261-692 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Aidarex Pharmaceuticals LLC NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 33261-699_d73d3c7c-5e0c-43b7-992c-105eb90c7103 33261-699 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Aidarex Pharmaceuticals LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-707_a9c631b4-b783-4a4b-9b9e-f79bb60a7437 33261-707 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20020301 OTC MONOGRAPH FINAL part333B Aidarex Pharmaceuticals LLC BACITRACIN ZINC 500 [USP'U]/g N 20181231 33261-714_81b5ab1e-b277-43ac-9a7b-d14d60457c12 33261-714 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Aidarex Pharmaceuticals LLC ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 33261-717_1288f851-da84-40fb-9b2c-d50c826fe791 33261-717 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Aidarex Pharmaceuticals LLC DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 33261-718_3c3b0660-703a-49d4-90ae-8b6a71bc049b 33261-718 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20100604 ANDA ANDA040659 Aidarex Pharmaceuticals LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 33261-724_56cf45ce-a692-486e-a961-3d53f18d418a 33261-724 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20130531 ANDA ANDA203399 Aidarex Pharmaceuticals LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 33261-726_2c889e7d-281d-49ad-be10-1d316637583d 33261-726 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Aidarex Pharmaceuticals LLC AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 33261-728_76932243-b0df-474c-aa58-b41c89d051d7 33261-728 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-730_42c39262-6a30-42e7-a2a8-5b1b98a0c851 33261-730 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 Aidarex Pharmaceuticals LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 33261-732_2c926159-2df1-424e-b19f-197833e3dd10 33261-732 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 20060214 ANDA ANDA040649 Aidarex Pharmaceuticals LLC DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 33261-737_716cfc62-96c0-46e2-aa7c-a8093b793195 33261-737 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20080317 ANDA ANDA076128 Aidarex Pharmaceuticals LLC OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 33261-738_e299aa52-24b3-4b98-9ea8-791b5f4c5628 33261-738 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20020917 ANDA ANDA075907 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33261-739_dcbd7cb5-fde6-4c95-b453-0b5c1c8dd069 33261-739 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075319 Aidarex Pharmaceuticals LLC KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 33261-740_625f2552-b7bf-4ee3-a58e-9e22578f2280 33261-740 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961203 ANDA ANDA040159 Aidarex Pharmaceuticals LLC MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 33261-741_25385136-ce02-4fd2-a88e-e27da4b0fc0e 33261-741 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Aidarex Pharmaceuticals LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 33261-745_1156d9cb-4ad2-49c0-b7ee-4b947c5dcc84 33261-745 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Aidarex Pharmaceuticals LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 33261-747_c864bb57-bef4-4d7d-91c7-7e70ce696656 33261-747 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Aidarex Pharmaceuticals LLC ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 33261-748_9c33b6af-82fa-46f5-805d-d2508400e10e 33261-748 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20060714 OTC MONOGRAPH FINAL part336 Aidarex Pharmaceuticals LLC MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 33261-749_99e011cc-0e61-4ecd-87c7-04d397ee15e6 33261-749 HUMAN OTC DRUG SENEXON-S DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20110316 OTC MONOGRAPH NOT FINAL part334 Aidarex Pharmaceuticals LLC DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 N 20181231 33261-754_384c955d-a727-43b5-be9e-3e6f501cf2d3 33261-754 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 Aidarex Pharmaceuticals LLC MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 33261-756_5a387e4b-9fde-43fa-bd07-ac2a369147ba 33261-756 HUMAN PRESCRIPTION DRUG Sulfasalazine sulfasalazine TABLET ORAL 20020111 ANDA ANDA040349 Aidarex Pharmaceuticals LLC SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 33261-758_7e7541d1-017e-4bcc-8ae6-3735c2b5d307 33261-758 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20070711 ANDA ANDA077621 Aidarex Pharmaceuticals LLC AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 33261-761_c864bb57-bef4-4d7d-91c7-7e70ce696656 33261-761 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Aidarex Pharmaceuticals LLC ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 33261-764_b82a7117-a881-4efb-a22a-69842616fbb5 33261-764 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Aidarex Pharmaceuticals LLC SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 33261-766_12a87643-479a-4a6c-b307-646c58aa89f6 33261-766 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Aidarex Pharmaceuticals LLC AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 33261-770_2af6c8f6-8041-421c-943a-7ee745600a9a 33261-770 HUMAN OTC DRUG good sense pain reliefchildrens childrens Acetaminophen SUSPENSION ORAL 19930225 OTC MONOGRAPH NOT FINAL part343 Aidarex Pharmaceuticals LLC ACETAMINOPHEN 160 mg/5mL N 20181231 33261-773_1a42734f-af17-498b-bc15-a3f7e0004fae 33261-773 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 Aidarex Pharmaceuticals LLC AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 33261-780_3eb42c9e-ade5-41e9-8fb2-32551a571d28 33261-780 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Aidarex Pharmaceuticals LLC PREDNISONE 5 mg/1 N 20181231 33261-786_fe04d17d-f5c0-4dc3-b61c-8b8a0c88f0d4 33261-786 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole GEL VAGINAL 20070331 NDA AUTHORIZED GENERIC NDA020208 Aidarex Pharmaceuticals LLC METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 33261-788_096a2ff6-e875-4d62-bad8-3afa55c8fede 33261-788 HUMAN OTC DRUG ProCoMycin Bacitracin, Neomycin, Polymyxin B and Lidocain Hydrochloride CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part348 Aidarex Pharmaceuticals LLC BACITRACIN; NEOMYCIN; POLYMYXIN B; LIDOCAINE HYDROCHLORIDE 500; .0035; 10000; .04 [iU]/g; g/g; [iU]/g; g/g N 20181231 33261-789_4649abda-b4ec-41f8-b1bc-d1ae0aade616 33261-789 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20111205 ANDA ANDA077839 Aidarex Pharmaceuticals LLC ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 33261-793_5de98130-babf-405b-994a-d117eef9ef57 33261-793 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Aidarex Pharmaceuticals LLC LEVOFLOXACIN 500 mg/1 N 20181231 33261-796_df8cbb50-2a88-45c4-8e36-8fdc9813aa17 33261-796 HUMAN OTC DRUG Promolaxin Docusate sodium TABLET ORAL 20110415 OTC MONOGRAPH NOT FINAL part334 Aidarex Pharmaceuticals LLC DOCUSATE SODIUM 100 mg/1 N 20181231 33261-797_7b3d0f95-398a-40f5-8c02-77031cf6de12 33261-797 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 33261-798_86561340-1ee9-44d0-adab-55bc9bbfe66a 33261-798 HUMAN OTC DRUG Acetadryl Acetaminophen and diphenhyramine TABLET, FILM COATED ORAL 20110721 OTC MONOGRAPH NOT FINAL part343 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 33261-804_7f8fad0a-267b-4284-9de3-14ddd77d9ac0 33261-804 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Aidarex Pharmaceuticals LLC NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 33261-810_294053a9-959b-49d5-a4e7-f0e4e2061e4e 33261-810 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018832 Aidarex Pharmaceuticals LLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 33261-811_764aad3f-97f7-4762-84b8-7df245c261b6 33261-811 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20090609 ANDA ANDA090035 Aidarex Pharmaceuticals LLC FOLIC ACID 1 mg/1 N 20181231 33261-813_fea6f761-235f-4d3d-99c6-6389070ec7d9 33261-813 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Aidarex Pharmaceuticals LLC GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 33261-814_8d4746af-7b95-4b44-9010-cc77908c2987 33261-814 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-816_8d4746af-7b95-4b44-9010-cc77908c2987 33261-816 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-817_656e9454-b292-4d3a-95d5-157e26365f3a 33261-817 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090425 Aidarex Pharmaceuticals LLC DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 33261-818_1641b016-62df-4c69-bfa4-e7b378e078bc 33261-818 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Aidarex Pharmaceuticals LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33261-819_1641b016-62df-4c69-bfa4-e7b378e078bc 33261-819 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Aidarex Pharmaceuticals LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33261-820_353a5ff7-34d8-4cb4-aaab-1cba7ed4b4de 33261-820 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Aidarex Pharmaceuticals LLC ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 33261-823_c89c67cd-6934-439f-b064-cab508c1cdda 33261-823 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 33261-824_b544b0fa-d59a-481e-bb83-a5e49e0ad5eb 33261-824 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 33261-825_c89c67cd-6934-439f-b064-cab508c1cdda 33261-825 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 33261-826_0d247451-52f8-45ba-a1ec-91401605c8d0 33261-826 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 33261-828_76932243-b0df-474c-aa58-b41c89d051d7 33261-828 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061004 ANDA ANDA077912 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-829_4da3b18f-eb1c-49ac-8387-07e16931208d 33261-829 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 Aidarex Pharmaceuticals LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 33261-830_3d03c9eb-c4a2-4d2c-9be3-3c18753096ad 33261-830 HUMAN PRESCRIPTION DRUG GlipizideER ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031101 ANDA ANDA076467 Aidarex Pharmaceuticals LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 33261-831_a3716d08-1cdd-4f4b-b463-d0bbca9e1e8a 33261-831 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Aidarex Pharmaceuticals LLC GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 33261-833_7cc09057-0a72-4ba6-9541-b8b5501d885f 33261-833 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20121025 ANDA ANDA090061 Aidarex Pharmaceuticals LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 33261-835_3d03c9eb-c4a2-4d2c-9be3-3c18753096ad 33261-835 HUMAN PRESCRIPTION DRUG GlipizideER ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031107 ANDA ANDA076467 Aidarex Pharmaceuticals LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 33261-838_77aef3a9-ef00-41af-b739-00592f4e3bdc 33261-838 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Aidarex Pharmaceuticals LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33261-839_22df39d3-1e71-4b07-8d0e-9ed581d66142 33261-839 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 Aidarex Pharmaceuticals LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 33261-840_5a9ac93d-ff59-4778-b735-9320d48d1c31 33261-840 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071003 ANDA ANDA077410 Aidarex Pharmaceuticals LLC NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 33261-841_c432adf9-17a7-4c67-8488-0c67c6185103 33261-841 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Aidarex Pharmaceuticals LLC OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 33261-842_c432adf9-17a7-4c67-8488-0c67c6185103 33261-842 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Aidarex Pharmaceuticals LLC OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 33261-843_b3e49f2c-8d6c-4690-863c-9417fb41ed05 33261-843 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20051222 ANDA ANDA077636 Aidarex Pharmaceuticals LLC ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 33261-846_2e92a75c-ab99-49b1-8033-efbbcace2d68 33261-846 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Aidarex Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 33261-847_404f5030-f1b4-4756-bd33-0c2a5e7afd8a 33261-847 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Aidarex Pharmaceuticals LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 33261-848_381aa246-233f-490b-80cb-91fef3b7bf56 33261-848 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Aidarex Pharmaceuticals LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 33261-849_dcae48af-ca48-4448-92b6-4ad661582bf4 33261-849 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Aidarex Pharmaceuticals LLC RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 33261-852_44f34237-4966-4f7f-8b00-873195c81adb 33261-852 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 Aidarex Pharmaceuticals LLC LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 33261-858_b0679889-19c0-4615-968d-a108d2482aeb 33261-858 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 Aidarex Pharmaceuticals LLC HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 33261-859_5a14624a-9938-4d95-b044-68766cf97e78 33261-859 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 Aidarex Pharmaceuticals LLC CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 33261-860_0b789977-c3b1-495d-9dcb-1d7f4295eb08 33261-860 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071994 Aidarex Pharmaceuticals LLC PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 33261-861_0b789977-c3b1-495d-9dcb-1d7f4295eb08 33261-861 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071995 Aidarex Pharmaceuticals LLC PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 33261-865_e06b299b-b1b6-40db-94b3-30d476196771 33261-865 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20120717 ANDA ANDA040712 Aidarex Pharmaceuticals LLC PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 33261-867_74ec5981-fcf7-4164-a03f-2d6656a5f46f 33261-867 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Aidarex Pharmaceuticals LLC PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 33261-868_74ec5981-fcf7-4164-a03f-2d6656a5f46f 33261-868 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Aidarex Pharmaceuticals LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 33261-869_b82a7117-a881-4efb-a22a-69842616fbb5 33261-869 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Aidarex Pharmaceuticals LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 33261-870_ce7c1472-b399-493e-a419-e71701b04acc 33261-870 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20010412 ANDA ANDA075498 Aidarex Pharmaceuticals LLC TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 33261-871_b467b2f6-9ecd-45be-a714-664764233d01 33261-871 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Aidarex Pharmaceuticals LLC MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 33261-873_363f91f4-00cf-461e-b14b-85923fed3331 33261-873 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010228 NDA NDA021077 Aidarex Pharmaceuticals LLC SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 100 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 33261-874_363f91f4-00cf-461e-b14b-85923fed3331 33261-874 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010205 NDA NDA021077 Aidarex Pharmaceuticals LLC SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 250 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 33261-876_5de98130-babf-405b-994a-d117eef9ef57 33261-876 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Aidarex Pharmaceuticals LLC LEVOFLOXACIN 750 mg/1 N 20181231 33261-879_335dec43-2c8b-4432-81e1-f9284a7a834f 33261-879 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 Aidarex Pharmaceuticals LLC AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 33261-880_17c072f1-844b-40b2-b764-bfa7347ffd0b 33261-880 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120314 NDA NDA022370 Aidarex Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 33261-881_a7273cd2-4d7a-4913-834c-dbdc0b9a5283 33261-881 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120517 ANDA ANDA040846 Aidarex Pharmaceuticals LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 33261-883_868cf43c-6ce2-49d0-b94f-039efab76e9c 33261-883 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20130905 ANDA ANDA076990 Aidarex Pharmaceuticals LLC FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-884_c8bbb594-e795-431e-aeb8-800da6a7db1f 33261-884 HUMAN OTC DRUG MEDROX MENTHOL, CAPSAICIN PATCH TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part348 Aidarex Pharmaceuticals LLC MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g N 20181231 33261-888_fdb92d03-2a1a-4b64-ad4f-391f8f977bb8 33261-888 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20051110 ANDA ANDA065277 Aidarex Pharmaceuticals LLC DOXYCYCLINE HYCLATE 20 mg/1 N 20181231 33261-891_5de98130-babf-405b-994a-d117eef9ef57 33261-891 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Aidarex Pharmaceuticals LLC LEVOFLOXACIN 250 mg/1 N 20181231 33261-892_0bbcdb96-76b4-4d74-a385-9ead00baa8ef 33261-892 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Aidarex Pharmaceuticals LLC GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 33261-895_b82a7117-a881-4efb-a22a-69842616fbb5 33261-895 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Aidarex Pharmaceuticals LLC SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 33261-896_a7bdbe31-8699-40f4-b6a1-d30b99cb97ec 33261-896 HUMAN PRESCRIPTION DRUG Nystatin nystatin TABLET, FILM COATED ORAL 19881222 ANDA ANDA062838 Aidarex Pharmaceuticals LLC NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 33261-898_f6787aa2-956b-47da-91fd-cdc7d8695df9 33261-898 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Aidarex Pharmaceuticals LLC METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 33261-899_e1ddd097-1fc0-467c-b770-4e815160bc04 33261-899 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19821013 ANDA ANDA062031 Aidarex Pharmaceuticals LLC DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 33261-900_ca6dd35c-a11d-498f-9086-9fd681470743 33261-900 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 Aidarex Pharmaceuticals LLC ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 33261-903_1ecbc0cc-35c9-46ff-b07d-b7d1ae7a9335 33261-903 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Aidarex Pharmaceuticals LLC RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-904_b125e99c-f968-4ece-9c23-64aa5b1e4986 33261-904 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA077732 Aidarex Pharmaceuticals LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33261-905_bb942e65-f5fb-4d99-801e-79c6b680e217 33261-905 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 Aidarex Pharmaceuticals LLC CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 33261-907_4da79ad0-8d67-4080-82db-8cab5f049213 33261-907 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Extended-Release Hyoscyamine Sulfate Extended-Release TABLET ORAL 20100103 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC HYOSCYAMINE SULFATE .375 mg/1 N 20181231 33261-908_c378686f-8bf4-4fff-9b88-d5a18ce37135 33261-908 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Aidarex Pharmaceuticals LLC LORATADINE 5 mg/5mL N 20181231 33261-918_67b56f89-ea09-427c-95ff-f358b6eb256e 33261-918 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 Aidarex Pharmaceuticals LLC BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33261-922_208b6d91-6e3f-48ac-a86d-767e735dadb8 33261-922 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, and Caffeine butalbital, aspirin, and caffeine CAPSULE ORAL 19760504 NDA AUTHORIZED GENERIC NDA017534 Aidarex Pharmaceuticals LLC BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 33261-933_ba4280ea-864c-4f79-97f9-7438fa0a6105 33261-933 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 Aidarex Pharmaceuticals LLC HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 33261-935_0a6cb56c-0b44-45d8-8538-ca16e678ab9b 33261-935 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Aidarex Pharmaceuticals LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-942_ca7a45f2-b48d-45b1-ab29-53da0dd9cf71 33261-942 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Aidarex Pharmaceuticals LLC ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 33261-944_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7 33261-944 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 33261-946_d62710fe-d3d0-4714-b3bb-e1f6dd916946 33261-946 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Aidarex Pharmaceuticals LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 33261-947_803c7ca1-ccca-4d6f-9365-d0c26530700a 33261-947 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20130205 ANDA ANDA090362 Aidarex Pharmaceuticals LLC LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 33261-950_77aef3a9-ef00-41af-b739-00592f4e3bdc 33261-950 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Aidarex Pharmaceuticals LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33261-951_a87947cb-f21c-4345-a83d-03518b670e9e 33261-951 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951226 ANDA ANDA074185 Aidarex Pharmaceuticals LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 33261-952_6316b11a-923a-4944-b814-31bd8a934db9 33261-952 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20090921 ANDA ANDA071251 Aidarex Pharmaceuticals LLC TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33261-953_74ec5981-fcf7-4164-a03f-2d6656a5f46f 33261-953 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Aidarex Pharmaceuticals LLC PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 33261-954_3c613066-4694-4de8-859a-7061e2a2e7b1 33261-954 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Aidarex Pharmaceuticals LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-955_fff7cc6b-ece8-4ff9-942d-118822b5eae5 33261-955 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 Aidarex Pharmaceuticals LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33261-956_210af85b-9e0f-4bd9-94f9-77ffe42b013f 33261-956 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20021126 ANDA ANDA076005 Aidarex Pharmaceuticals LLC ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 33261-959_9c180770-0e8d-4dde-b049-8b3a615cf105 33261-959 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Aidarex Pharmaceuticals LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 33261-960_d21288f6-b27e-4d24-93ba-2422b08036ba 33261-960 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150701 NDA NDA022370 Aidarex Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 33261-963_265be229-6d0b-4ceb-a94a-7f84ca2c3141 33261-963 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 Aidarex Pharmaceuticals LLC DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 33261-964_2e490478-f34d-4b76-bdac-b9678042bb3a 33261-964 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Aidarex Pharmaceuticals LLC LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 33261-966_7cab8cc1-8128-45fc-87a2-639f07d4d60f 33261-966 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Aidarex Pharmaceuticals LLC FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 33261-967_1ecbc0cc-35c9-46ff-b07d-b7d1ae7a9335 33261-967 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Aidarex Pharmaceuticals LLC RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-969_733ee823-ddd2-45b5-9d27-44105e5bf34c 33261-969 HUMAN PRESCRIPTION DRUG montelukast sodium montelukast sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA090926 Aidarex Pharmaceuticals LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 33261-970_2fce4fed-89a2-4fa9-a1b0-a8dc087ae983 33261-970 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20010622 NDA NDA050755 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 33261-972_4cea1f5c-07d8-4ae8-8d22-5578b510c62d 33261-972 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Aidarex Pharmaceuticals LLC ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 33261-974_b01ba900-3657-4093-875f-11c5140561a3 33261-974 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Aidarex Pharmaceuticals LLC CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 33261-975_725bef53-880f-4402-8b86-b732911c80bf 33261-975 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aidarex Pharmaceuticals LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 33261-982_bbb38451-c948-492b-9998-cebf028a6052 33261-982 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aidarex Pharmaceuticals LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 33261-983_ae72cf6a-bf5f-424c-8d8c-1aaffbb89826 33261-983 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Aidarex Pharmaceuticals LLC BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 33261-986_725bef53-880f-4402-8b86-b732911c80bf 33261-986 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aidarex Pharmaceuticals LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 33261-987_0ea55b0e-a44e-4b1f-be1b-314d92b7ccc2 33261-987 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 Aidarex Pharmaceuticals LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 33261-988_0793439e-5691-4317-b98d-66079435969e 33261-988 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 33261-989_603f002e-7b62-4777-be74-66e0ffffb894 33261-989 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 33261-992_c85bc0c3-d37b-454b-ba21-199a6d33e9ba 33261-992 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 19990610 ANDA ANDA075191 Aidarex Pharmaceuticals LLC PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 33261-993_78a8700b-3eb9-4c00-b274-3bddc6208a34 33261-993 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Aidarex Pharmaceuticals LLC ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 33261-994_49778501-d326-4ead-9fa5-b9d30228ff2d 33261-994 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111122 ANDA ANDA079057 Aidarex Pharmaceuticals LLC ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 33261-996_1641b016-62df-4c69-bfa4-e7b378e078bc 33261-996 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Aidarex Pharmaceuticals LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33332-015_91776d76-04ff-438a-84a8-08d54e161ae0 33332-015 VACCINE AFLURIA INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20110715 BLA BLA125254 bioCSL Pty Ltd. INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 IVR-175 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL Inactivated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient] E 20171231 33332-017_75d0d8d7-6c04-4a34-a305-95b4f89d3e8e 33332-017 VACCINE AFLURIA INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/46/2015 ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20110715 BLA BLA125254 Seqirus Pty Ltd INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/46/2015 ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL N 20181231 33332-115_91776d76-04ff-438a-84a8-08d54e161ae0 33332-115 VACCINE AFLURIA INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20110715 BLA BLA125254 bioCSL Pty Ltd. INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 IVR-175 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL Inactivated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient] E 20171231 33332-117_75d0d8d7-6c04-4a34-a305-95b4f89d3e8e 33332-117 VACCINE AFLURIA INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), AND INFLUENZA B VIRUS B/BRISBANE/46/2015 ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20110715 BLA BLA125254 Seqirus Pty Ltd IINFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/46/2015 ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL N 20181231 33332-317_05e139ee-fc74-481e-be2b-8dbaa34390b0 33332-317 VACCINE AFLURIA QUADRIVALENT INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/BRISBANE/46/2015 ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20160928 BLA BLA125254 Seqirus Pty Ltd INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/46/2015 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL N 20181231 33332-417_05e139ee-fc74-481e-be2b-8dbaa34390b0 33332-417 VACCINE AFLURIA QUADRIVALENT INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/BRISBANE/46/2015 ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20170816 BLA BLA125254 Seqirus Pty Ltd INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/46/2015 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL N 20181231 33335-001_4c549120-6261-429c-87cf-98f264a9925f 33335-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19410101 NDA NDA205767 WELSCO, INC. OXYGEN 995 mL/L N 20181231 33335-002_257ce7f7-9855-4759-be3e-79cb80a75458 33335-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20010101 NDA NDA205766 WELSCO, INC. NITROGEN 990 mL/L N 20181231 33342-015_cf534093-9769-44f3-8570-337fad041447 33342-015 HUMAN PRESCRIPTION DRUG Amlodipine Amlodipine TABLET ORAL 20120413 ANDA ANDA201380 Macleods Pharmaceuticals Limited AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 33342-016_cf534093-9769-44f3-8570-337fad041447 33342-016 HUMAN PRESCRIPTION DRUG Amlodipine Amlodipine TABLET ORAL 20120413 ANDA ANDA201380 Macleods Pharmaceuticals Limited AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 33342-019_50e32ce4-14df-4526-9018-2e98a5960fa0 33342-019 HUMAN PRESCRIPTION DRUG Pantoprazole sodium Pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20111203 ANDA ANDA200821 Macleods Pharmaceuticals Limited PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 33342-020_50e32ce4-14df-4526-9018-2e98a5960fa0 33342-020 HUMAN PRESCRIPTION DRUG Pantoprazole sodium Pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20111203 ANDA ANDA200821 Macleods Pharmaceuticals Limited PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 33342-021_73aaf671-c229-4994-bd0e-2ae38c7248c3 33342-021 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Macleods Pharmaceuticals Limited LEVOFLOXACIN 250 mg/1 N 20181231 33342-022_73aaf671-c229-4994-bd0e-2ae38c7248c3 33342-022 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Macleods Pharmaceuticals Limited LEVOFLOXACIN 500 mg/1 N 20181231 33342-023_73aaf671-c229-4994-bd0e-2ae38c7248c3 33342-023 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Macleods Pharmaceuticals Limited LEVOFLOXACIN 750 mg/1 N 20181231 33342-024_98587b0d-f8d5-4b9c-aa5e-fc845f0dba1c 33342-024 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20111217 ANDA ANDA201022 Macleods Pharmaceuticals Limited FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 33342-025_98587b0d-f8d5-4b9c-aa5e-fc845f0dba1c 33342-025 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20111217 ANDA ANDA201022 Macleods Pharmaceuticals Limited FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 33342-026_98587b0d-f8d5-4b9c-aa5e-fc845f0dba1c 33342-026 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20111217 ANDA ANDA201022 Macleods Pharmaceuticals Limited FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 33342-027_702e6c87-17c6-4377-9172-992468a0e0d2 33342-027 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA201146 Macleods Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 33342-028_702e6c87-17c6-4377-9172-992468a0e0d2 33342-028 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA201146 Macleods Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 33342-029_702e6c87-17c6-4377-9172-992468a0e0d2 33342-029 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20121214 ANDA ANDA201787 Macleods Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 33342-030_702e6c87-17c6-4377-9172-992468a0e0d2 33342-030 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20121214 ANDA ANDA201787 Macleods Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 33342-031_8de66dbe-0d46-441f-90be-ce1901daba6f 33342-031 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20120921 ANDA ANDA202164 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 33342-032_8de66dbe-0d46-441f-90be-ce1901daba6f 33342-032 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20120921 ANDA ANDA202164 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 33342-033_8de66dbe-0d46-441f-90be-ce1901daba6f 33342-033 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20120921 ANDA ANDA202164 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 33342-034_8de66dbe-0d46-441f-90be-ce1901daba6f 33342-034 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20120921 ANDA ANDA202164 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 33342-035_8de66dbe-0d46-441f-90be-ce1901daba6f 33342-035 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20120921 ANDA ANDA202164 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 33342-036_9feaaa52-57e5-45b0-a740-c97292837fe7 33342-036 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA202210 Macleods Pharmaceuticals Limited ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33342-037_9feaaa52-57e5-45b0-a740-c97292837fe7 33342-037 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA202210 Macleods Pharmaceuticals Limited ESCITALOPRAM OXALATE 10 mg/21 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33342-038_9feaaa52-57e5-45b0-a740-c97292837fe7 33342-038 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA202210 Macleods Pharmaceuticals Limited ESCITALOPRAM OXALATE 20 mg/21 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33342-044_4eb8ef62-651d-498a-8c6c-78ddcda2ce9f 33342-044 HUMAN PRESCRIPTION DRUG Losartan potassium Losartan potassium TABLET, FILM COATED ORAL 20120510 ANDA ANDA202230 Macleods Pharmaceuticals Limited LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-045_4eb8ef62-651d-498a-8c6c-78ddcda2ce9f 33342-045 HUMAN PRESCRIPTION DRUG Losartan potassium Losartan potassium TABLET, FILM COATED ORAL 20120601 ANDA ANDA202230 Macleods Pharmaceuticals Limited LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-046_4eb8ef62-651d-498a-8c6c-78ddcda2ce9f 33342-046 HUMAN PRESCRIPTION DRUG Losartan potassium Losartan potassium TABLET, FILM COATED ORAL 20120601 ANDA ANDA202230 Macleods Pharmaceuticals Limited LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-047_6972370d-95b1-4952-af3c-0a03c1f5bcf0 33342-047 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202254 Macleods Pharmaceuticals Limited IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-048_6972370d-95b1-4952-af3c-0a03c1f5bcf0 33342-048 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202254 Macleods Pharmaceuticals Limited IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-049_6972370d-95b1-4952-af3c-0a03c1f5bcf0 33342-049 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202254 Macleods Pharmaceuticals Limited IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-050_ed39cb2d-25a3-40bd-be89-ab63d83e4d62 33342-050 HUMAN PRESCRIPTION DRUG Losartan potassium and Hydrochlorothiazide Losartan potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120503 ANDA ANDA202289 Macleods Pharmaceuticals Limited LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-051_ed39cb2d-25a3-40bd-be89-ab63d83e4d62 33342-051 HUMAN PRESCRIPTION DRUG Losartan potassium and Hydrochlorothiazide Losartan potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120503 ANDA ANDA202289 Macleods Pharmaceuticals Limited LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-052_ed39cb2d-25a3-40bd-be89-ab63d83e4d62 33342-052 HUMAN PRESCRIPTION DRUG Losartan potassium and Hydrochlorothiazide Losartan potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120503 ANDA ANDA202289 Macleods Pharmaceuticals Limited LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-053_88bc86c2-9618-4064-93e0-e1e579e4dc64 33342-053 HUMAN PRESCRIPTION DRUG escitalopram escitalopram SOLUTION ORAL 20160331 ANDA ANDA202754 Macleods Pharmaceuticals Limited ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 33342-054_3f073771-cbe1-4575-9f4c-44a6e5c1f90d 33342-054 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130214 ANDA ANDA202467 Macleods Pharmaceuticals Limited PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 33342-055_3f073771-cbe1-4575-9f4c-44a6e5c1f90d 33342-055 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130214 ANDA ANDA202467 Macleods Pharmaceuticals Limited PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 33342-056_3f073771-cbe1-4575-9f4c-44a6e5c1f90d 33342-056 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130214 ANDA ANDA202467 Macleods Pharmaceuticals Limited PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 33342-057_75593546-cbb2-4213-ab52-96c2dac686f8 33342-057 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120927 ANDA ANDA202414 Macleods Pharmaceuticals Limited IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-058_75593546-cbb2-4213-ab52-96c2dac686f8 33342-058 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120927 ANDA ANDA202414 Macleods Pharmaceuticals Limited IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-060_2c5f8c27-afb7-4677-8426-e7d6ffb103e0 33342-060 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET ORAL 20121016 ANDA ANDA202928 Macleods Pharmaceuticals Limited CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 33342-061_702e6c87-17c6-4377-9172-992468a0e0d2 33342-061 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20140123 ANDA ANDA202631 Macleods Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 33342-062_9108b23d-2bdb-4d1d-9833-8aeb6bce52a6 33342-062 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160829 ANDA ANDA202696 Macleods Pharmaceuticals Limited VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-063_9108b23d-2bdb-4d1d-9833-8aeb6bce52a6 33342-063 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160829 ANDA ANDA202696 Macleods Pharmaceuticals Limited VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-064_9108b23d-2bdb-4d1d-9833-8aeb6bce52a6 33342-064 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160829 ANDA ANDA202696 Macleods Pharmaceuticals Limited VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-065_9108b23d-2bdb-4d1d-9833-8aeb6bce52a6 33342-065 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160829 ANDA ANDA202696 Macleods Pharmaceuticals Limited VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-066_42f0a9f2-4aa4-46fb-bc24-d3df843bb906 33342-066 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride SOLUTION ORAL 20151013 ANDA ANDA202790 Macleods Pharmaceuticals Limited MEMANTINE HYDROCHLORIDE 2 mg/mL NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 33342-067_94c05bab-055a-4bbc-8a23-11e1e9f603b4 33342-067 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Macleods Pharmaceuticals Limited OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-068_94c05bab-055a-4bbc-8a23-11e1e9f603b4 33342-068 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Macleods Pharmaceuticals Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-069_94c05bab-055a-4bbc-8a23-11e1e9f603b4 33342-069 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Macleods Pharmaceuticals Limited OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-070_94c05bab-055a-4bbc-8a23-11e1e9f603b4 33342-070 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Macleods Pharmaceuticals Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-071_94c05bab-055a-4bbc-8a23-11e1e9f603b4 33342-071 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Macleods Pharmaceuticals Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-072_94c05bab-055a-4bbc-8a23-11e1e9f603b4 33342-072 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Macleods Pharmaceuticals Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-074_882aae69-13f2-426b-a4b2-d4b45fc50551 33342-074 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 Macleods Pharmaceuticals Limited VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-075_882aae69-13f2-426b-a4b2-d4b45fc50551 33342-075 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 Macleods Pharmaceuticals Limited VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-076_882aae69-13f2-426b-a4b2-d4b45fc50551 33342-076 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET ORAL 20130419 ANDA ANDA203145 Macleods Pharmaceuticals Limited VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-077_882aae69-13f2-426b-a4b2-d4b45fc50551 33342-077 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 Macleods Pharmaceuticals Limited VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-078_882aae69-13f2-426b-a4b2-d4b45fc50551 33342-078 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 Macleods Pharmaceuticals Limited VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-083_96c16f25-e133-418a-8d64-2a3527d1075f 33342-083 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20150227 ANDA ANDA203044 Macleods Pharmaceuticals Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-084_96c16f25-e133-418a-8d64-2a3527d1075f 33342-084 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20150227 ANDA ANDA203044 Macleods Pharmaceuticals Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-085_96c16f25-e133-418a-8d64-2a3527d1075f 33342-085 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20150227 ANDA ANDA203044 Macleods Pharmaceuticals Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-086_96c16f25-e133-418a-8d64-2a3527d1075f 33342-086 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20150227 ANDA ANDA203044 Macleods Pharmaceuticals Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-087_576def02-7739-487e-a858-ed1e7a9763c4 33342-087 HUMAN PRESCRIPTION DRUG Rizatriptan Rizatriptan TABLET, FILM COATED ORAL 20140311 ANDA ANDA203147 Macleods Pharmaceuticals Limited RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 33342-088_576def02-7739-487e-a858-ed1e7a9763c4 33342-088 HUMAN PRESCRIPTION DRUG Rizatriptan Rizatriptan TABLET, FILM COATED ORAL 20140311 ANDA ANDA203147 Macleods Pharmaceuticals Limited RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 33342-089_9587a49c-2aa2-48f4-af9e-79cdbe95193c 33342-089 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20140902 ANDA ANDA203148 Macleods Pharmaceuticals Limited RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 33342-090_9587a49c-2aa2-48f4-af9e-79cdbe95193c 33342-090 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20140902 ANDA ANDA203148 Macleods Pharmaceuticals Limited RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 33342-091_9587a49c-2aa2-48f4-af9e-79cdbe95193c 33342-091 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20140902 ANDA ANDA203148 Macleods Pharmaceuticals Limited RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 33342-092_9587a49c-2aa2-48f4-af9e-79cdbe95193c 33342-092 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20140902 ANDA ANDA203148 Macleods Pharmaceuticals Limited RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 33342-093_7ec20bbc-1652-4132-a6b9-28a1289439d0 33342-093 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20140923 ANDA ANDA203146 Macleods Pharmaceuticals Limited RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 33342-094_7ec20bbc-1652-4132-a6b9-28a1289439d0 33342-094 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20140923 ANDA ANDA203146 Macleods Pharmaceuticals Limited RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 33342-096_532755cb-1cd3-4774-97af-05a53779b65f 33342-096 HUMAN PRESCRIPTION DRUG tenofovir disproxil fumarate tenofovir disproxil fumarate TABLET ORAL 20180126 ANDA ANDA203232 Macleods Pharmaceuticals Limited TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 33342-097_3f2291c3-7e3c-41be-afa6-ef73ce896e30 33342-097 HUMAN PRESCRIPTION DRUG Tolterodine tartrate Tolterodine tartrate TABLET, FILM COATED ORAL 20151008 ANDA ANDA203409 Macleods Pharmaceuticals Limited TOLTERODINE TARTRATE 1 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 33342-098_3f2291c3-7e3c-41be-afa6-ef73ce896e30 33342-098 HUMAN PRESCRIPTION DRUG Tolterodine tartrate Tolterodine tartrate TABLET, FILM COATED ORAL 20151008 ANDA ANDA203409 Macleods Pharmaceuticals Limited TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 33342-099_e47c33fb-b2fc-4c6c-83e6-1573fa121c6c 33342-099 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20160614 ANDA ANDA203359 Macleods Pharmaceuticals Limited QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-100_e47c33fb-b2fc-4c6c-83e6-1573fa121c6c 33342-100 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20160614 ANDA ANDA203359 Macleods Pharmaceuticals Limited QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-101_e47c33fb-b2fc-4c6c-83e6-1573fa121c6c 33342-101 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20160614 ANDA ANDA203359 Macleods Pharmaceuticals Limited QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-102_e265e1b6-6668-49be-aef6-9df1ef73819f 33342-102 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET ORAL 20120228 ANDA ANDA203366 Macleods Pharmaceuticals Limited MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 33342-103_e47c33fb-b2fc-4c6c-83e6-1573fa121c6c 33342-103 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20160614 ANDA ANDA203359 Macleods Pharmaceuticals Limited QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-104_e47c33fb-b2fc-4c6c-83e6-1573fa121c6c 33342-104 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20160614 ANDA ANDA203359 Macleods Pharmaceuticals Limited QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-105_e47c33fb-b2fc-4c6c-83e6-1573fa121c6c 33342-105 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20160614 ANDA ANDA203359 Macleods Pharmaceuticals Limited QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-107_60fab319-1327-453b-b2b5-f3892766927f 33342-107 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20151209 ANDA ANDA203533 Macleods Pharmaceuticals Limited RISEDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 33342-108_60fab319-1327-453b-b2b5-f3892766927f 33342-108 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20151209 ANDA ANDA203533 Macleods Pharmaceuticals Limited RISEDRONATE SODIUM 30 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 33342-109_60fab319-1327-453b-b2b5-f3892766927f 33342-109 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20151209 ANDA ANDA203533 Macleods Pharmaceuticals Limited RISEDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 33342-110_3d5ccdc5-b890-44b3-9104-baa689e6f33c 33342-110 HUMAN PRESCRIPTION DRUG Montelukast sodium Montelukast sodium TABLET, CHEWABLE ORAL 20140401 ANDA ANDA203582 Macleods Pharmaceuticals Limited MONTELUKAST 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 33342-111_3d5ccdc5-b890-44b3-9104-baa689e6f33c 33342-111 HUMAN PRESCRIPTION DRUG Montelukast sodium Montelukast sodium TABLET, CHEWABLE ORAL 20131227 ANDA ANDA203582 Macleods Pharmaceuticals Limited MONTELUKAST 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 33342-112_e0c26d64-80be-4f1e-a406-bbb1a161a04b 33342-112 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20150930 ANDA ANDA203772 Macleods Pharmaceuticals Limited ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 33342-113_e0c26d64-80be-4f1e-a406-bbb1a161a04b 33342-113 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20150930 ANDA ANDA203772 Macleods Pharmaceuticals Limited ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 33342-114_fef1f83e-fcfb-447d-ab40-1780fab64dc0 33342-114 HUMAN PRESCRIPTION DRUG Candesartan Candesartan TABLET ORAL 20161206 ANDA ANDA203813 Macleods Pharmaceuticals Limited CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-115_fef1f83e-fcfb-447d-ab40-1780fab64dc0 33342-115 HUMAN PRESCRIPTION DRUG Candesartan Candesartan TABLET ORAL 20161206 ANDA ANDA203813 Macleods Pharmaceuticals Limited CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-116_fef1f83e-fcfb-447d-ab40-1780fab64dc0 33342-116 HUMAN PRESCRIPTION DRUG Candesartan Candesartan TABLET ORAL 20161206 ANDA ANDA203813 Macleods Pharmaceuticals Limited CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-117_fef1f83e-fcfb-447d-ab40-1780fab64dc0 33342-117 HUMAN PRESCRIPTION DRUG Candesartan Candesartan TABLET ORAL 20161206 ANDA ANDA203813 Macleods Pharmaceuticals Limited CANDESARTAN CILEXETIL 32 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-121_73a8c909-739e-4b3f-9939-779d59d5ba74 33342-121 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20140103 ANDA ANDA203814 Macleods Pharmaceuticals Limited SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 33342-122_7d3cdb9e-6d1a-4ad2-96f6-83ce8b5b0b50 33342-122 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20161008 ANDA ANDA204111 Macleods Pharmaceuticals Limited ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-123_7d3cdb9e-6d1a-4ad2-96f6-83ce8b5b0b50 33342-123 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20161008 ANDA ANDA204111 Macleods Pharmaceuticals Limited ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-124_7d3cdb9e-6d1a-4ad2-96f6-83ce8b5b0b50 33342-124 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20161008 ANDA ANDA204111 Macleods Pharmaceuticals Limited ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-125_7d3cdb9e-6d1a-4ad2-96f6-83ce8b5b0b50 33342-125 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20161008 ANDA ANDA204111 Macleods Pharmaceuticals Limited ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-126_7d3cdb9e-6d1a-4ad2-96f6-83ce8b5b0b50 33342-126 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20161008 ANDA ANDA204111 Macleods Pharmaceuticals Limited ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-127_7d3cdb9e-6d1a-4ad2-96f6-83ce8b5b0b50 33342-127 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20161008 ANDA ANDA204111 Macleods Pharmaceuticals Limited ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-128_100cc14a-8e79-4f2d-860c-057e28b133ec 33342-128 HUMAN PRESCRIPTION DRUG TELMISARTAN and HYDROCHLOROTHIAZIDE TELMISARTAN and HYDROCHLOROTHIAZIDE TABLET ORAL 20151102 ANDA ANDA204169 Macleods Pharmaceuticals Limited TELMISARTAN; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-129_100cc14a-8e79-4f2d-860c-057e28b133ec 33342-129 HUMAN PRESCRIPTION DRUG TELMISARTAN and HYDROCHLOROTHIAZIDE TELMISARTAN and HYDROCHLOROTHIAZIDE TABLET ORAL 20151102 ANDA ANDA204169 Macleods Pharmaceuticals Limited TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-130_100cc14a-8e79-4f2d-860c-057e28b133ec 33342-130 HUMAN PRESCRIPTION DRUG TELMISARTAN and HYDROCHLOROTHIAZIDE TELMISARTAN and HYDROCHLOROTHIAZIDE TABLET ORAL 20151102 ANDA ANDA204169 Macleods Pharmaceuticals Limited TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 33342-131_e355f53c-0710-4d0c-86e0-152760e11b5c 33342-131 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide TABLET ORAL 20150307 ANDA ANDA204100 Macleods Pharmaceuticals Limited CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 33342-132_e355f53c-0710-4d0c-86e0-152760e11b5c 33342-132 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide TABLET ORAL 20150307 ANDA ANDA204100 Macleods Pharmaceuticals Limited CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 33342-133_e355f53c-0710-4d0c-86e0-152760e11b5c 33342-133 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide TABLET ORAL 20150307 ANDA ANDA204100 Macleods Pharmaceuticals Limited CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 33342-134_d699b8c7-8a1c-44ed-85d8-c821a9c8c848 33342-134 HUMAN PRESCRIPTION DRUG QUETIAPINE QUETIAPINE TABLET, EXTENDED RELEASE ORAL 20171101 ANDA ANDA204253 Macleods Pharmaceuticals Limited QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-135_d699b8c7-8a1c-44ed-85d8-c821a9c8c848 33342-135 HUMAN PRESCRIPTION DRUG QUETIAPINE QUETIAPINE TABLET, EXTENDED RELEASE ORAL 20171101 ANDA ANDA204253 Macleods Pharmaceuticals Limited QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-136_d699b8c7-8a1c-44ed-85d8-c821a9c8c848 33342-136 HUMAN PRESCRIPTION DRUG QUETIAPINE QUETIAPINE TABLET, EXTENDED RELEASE ORAL 20171101 ANDA ANDA204253 Macleods Pharmaceuticals Limited QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-137_d699b8c7-8a1c-44ed-85d8-c821a9c8c848 33342-137 HUMAN PRESCRIPTION DRUG QUETIAPINE QUETIAPINE TABLET, EXTENDED RELEASE ORAL 20171101 ANDA ANDA204253 Macleods Pharmaceuticals Limited QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-139_e0c26d64-80be-4f1e-a406-bbb1a161a04b 33342-139 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20151022 ANDA ANDA204336 Macleods Pharmaceuticals Limited ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 33342-140_e0c26d64-80be-4f1e-a406-bbb1a161a04b 33342-140 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20151022 ANDA ANDA204336 Macleods Pharmaceuticals Limited ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 33342-144_3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af0 33342-144 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20170218 ANDA ANDA204375 Macleods Pharmaceuticals Limited ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-145_3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af0 33342-145 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20170218 ANDA ANDA204375 Macleods Pharmaceuticals Limited ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-146_3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af0 33342-146 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20170218 ANDA ANDA204375 Macleods Pharmaceuticals Limited ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-147_3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af0 33342-147 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20170218 ANDA ANDA204375 Macleods Pharmaceuticals Limited ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 33342-150_a5741ef6-0599-4657-8cda-2902ded4f680 33342-150 HUMAN PRESCRIPTION DRUG IBANDRONATE SODIUM IBANDRONATE SODIUM TABLET, FILM COATED ORAL 20171101 ANDA ANDA206887 Macleods Pharmaceuticals Limited IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 33342-155_3f00177b-4ca6-4f70-bd8e-ec1cf5e76ab8 33342-155 HUMAN PRESCRIPTION DRUG celecoxib celecoxib CAPSULE ORAL 20160316 ANDA ANDA204590 Macleods Pharmaceuticals Limited CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33342-156_3f00177b-4ca6-4f70-bd8e-ec1cf5e76ab8 33342-156 HUMAN PRESCRIPTION DRUG celecoxib celecoxib CAPSULE ORAL 20160316 ANDA ANDA204590 Macleods Pharmaceuticals Limited CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33342-157_3f00177b-4ca6-4f70-bd8e-ec1cf5e76ab8 33342-157 HUMAN PRESCRIPTION DRUG celecoxib celecoxib CAPSULE ORAL 20160316 ANDA ANDA204590 Macleods Pharmaceuticals Limited CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33342-158_3f00177b-4ca6-4f70-bd8e-ec1cf5e76ab8 33342-158 HUMAN PRESCRIPTION DRUG celecoxib celecoxib CAPSULE ORAL 20160316 ANDA ANDA204590 Macleods Pharmaceuticals Limited CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33342-159_082bf2d6-9e33-4040-aea6-02a8a26e8029 33342-159 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20170125 ANDA ANDA204645 Macleods Pharmaceuticals Limited TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 33342-160_0a808953-f71c-4824-8cd2-8f45b0d30090 33342-160 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20170324 ANDA ANDA204815 Macleods Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 33342-161_0a808953-f71c-4824-8cd2-8f45b0d30090 33342-161 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20170324 ANDA ANDA204815 Macleods Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 33342-162_0a808953-f71c-4824-8cd2-8f45b0d30090 33342-162 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20170324 ANDA ANDA204815 Macleods Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 33342-176_4f69c0b3-cc8f-4782-a4cd-c3574104d8c8 33342-176 HUMAN PRESCRIPTION DRUG Pioglitazole and metformin hydrochloride Pioglitazole and metformin hydrochloride TABLET ORAL 20151106 ANDA ANDA204802 Macleods Pharmaceuticals Limited PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 500 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 33342-177_4f69c0b3-cc8f-4782-a4cd-c3574104d8c8 33342-177 HUMAN PRESCRIPTION DRUG Pioglitazole and metformin hydrochloride Pioglitazole and metformin hydrochloride TABLET ORAL 20151106 ANDA ANDA204802 Macleods Pharmaceuticals Limited PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 850 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 33342-178_24e308cc-7cec-4054-9627-66f743ed71b0 33342-178 HUMAN PRESCRIPTION DRUG Olmesartan medoxomil Olmesartan medoxomil TABLET ORAL 20170425 ANDA ANDA204814 Macleods Pharmaceuticals Limited OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-179_24e308cc-7cec-4054-9627-66f743ed71b0 33342-179 HUMAN PRESCRIPTION DRUG Olmesartan medoxomil Olmesartan medoxomil TABLET ORAL 20170425 ANDA ANDA204814 Macleods Pharmaceuticals Limited OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-180_24e308cc-7cec-4054-9627-66f743ed71b0 33342-180 HUMAN PRESCRIPTION DRUG Olmesartan medoxomil Olmesartan medoxomil TABLET ORAL 20170425 ANDA ANDA204814 Macleods Pharmaceuticals Limited OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-190_fe631b31-e7a3-4ebf-a574-bd4a96710ff5 33342-190 HUMAN PRESCRIPTION DRUG AMLODIPINE and OLMESARTAN medoxomil AMLODIPINE and OLMESARTAN medoxomil TABLET, FILM COATED ORAL 20161027 ANDA ANDA206884 Macleods Pharmaceuticals Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-191_fe631b31-e7a3-4ebf-a574-bd4a96710ff5 33342-191 HUMAN PRESCRIPTION DRUG AMLODIPINE and OLMESARTAN medoxomil AMLODIPINE and OLMESARTAN medoxomil TABLET, FILM COATED ORAL 20161027 ANDA ANDA206884 Macleods Pharmaceuticals Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-192_fe631b31-e7a3-4ebf-a574-bd4a96710ff5 33342-192 HUMAN PRESCRIPTION DRUG AMLODIPINE and OLMESARTAN medoxomil AMLODIPINE and OLMESARTAN medoxomil TABLET, FILM COATED ORAL 20161027 ANDA ANDA206884 Macleods Pharmaceuticals Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-193_fe631b31-e7a3-4ebf-a574-bd4a96710ff5 33342-193 HUMAN PRESCRIPTION DRUG AMLODIPINE and OLMESARTAN medoxomil AMLODIPINE and OLMESARTAN medoxomil TABLET, FILM COATED ORAL 20161027 ANDA ANDA206884 Macleods Pharmaceuticals Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 33342-194_b1598a81-64af-4bd2-bc49-6e66dc4b7a55 33342-194 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171006 ANDA ANDA204889 Macleods Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 33342-195_b1598a81-64af-4bd2-bc49-6e66dc4b7a55 33342-195 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171006 ANDA ANDA204889 Macleods Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 33342-196_b1598a81-64af-4bd2-bc49-6e66dc4b7a55 33342-196 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171006 ANDA ANDA204889 Macleods Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 33342-200_16b74d32-f32c-4a33-8480-c7fd8accb311 33342-200 HUMAN PRESCRIPTION DRUG LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED ORAL 20160111 ANDA ANDA205564 Macleods Pharmaceuticals Limited LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 33342-201_985d5569-945b-4c6e-9272-5bcb3e08f355 33342-201 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20151007 ANDA ANDA205702 Macleods Pharmaceuticals Limited TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 33342-202_bd58a059-7f29-4e04-94c2-9b1bd68cf5a7 33342-202 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20170503 ANDA ANDA206885 Macleods Pharmaceuticals Limited TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 33342-208_c7546b9c-ef8b-4526-b86b-75fbd071cc31 33342-208 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20170101 ANDA ANDA206156 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .375 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 33342-209_c7546b9c-ef8b-4526-b86b-75fbd071cc31 33342-209 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20170101 ANDA ANDA206156 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 33342-210_c7546b9c-ef8b-4526-b86b-75fbd071cc31 33342-210 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20170101 ANDA ANDA206156 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 33342-211_c7546b9c-ef8b-4526-b86b-75fbd071cc31 33342-211 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20170101 ANDA ANDA206156 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 2.25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 33342-212_c7546b9c-ef8b-4526-b86b-75fbd071cc31 33342-212 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20170101 ANDA ANDA206156 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 33342-213_c7546b9c-ef8b-4526-b86b-75fbd071cc31 33342-213 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20170101 ANDA ANDA206156 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 3.75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 33342-214_c7546b9c-ef8b-4526-b86b-75fbd071cc31 33342-214 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20170101 ANDA ANDA206156 Macleods Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 4.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 33342-238_2620b114-f53f-44f1-8708-697e86343090 33342-238 HUMAN PRESCRIPTION DRUG NEVIRAPINE NEVIRAPINE TABLET, EXTENDED RELEASE ORAL 20171007 ANDA ANDA206879 Macleods Pharmaceuticals Limited NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 33342-239_f7f47dad-99c7-4e16-94b2-f3cd34f38892 33342-239 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20161208 ANDA ANDA206955 Macleods Pharmaceuticals Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 33342-240_f7f47dad-99c7-4e16-94b2-f3cd34f38892 33342-240 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20161208 ANDA ANDA206955 Macleods Pharmaceuticals Limited METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 33342-256_e9307620-36bd-46c2-a8b2-027d3fba87ba 33342-256 HUMAN PRESCRIPTION DRUG oseltamavir phosphate oseltamavir phosphate CAPSULE ORAL 20170921 ANDA ANDA207211 Macleods Pharmaceuticals Limited OSELTAMIVIR PHOSPHATE 30 mg/1 N 20181231 33342-257_e9307620-36bd-46c2-a8b2-027d3fba87ba 33342-257 HUMAN PRESCRIPTION DRUG oseltamavir phosphate oseltamavir phosphate CAPSULE ORAL 20170921 ANDA ANDA207211 Macleods Pharmaceuticals Limited OSELTAMIVIR PHOSPHATE 45 mg/1 N 20181231 33342-258_e9307620-36bd-46c2-a8b2-027d3fba87ba 33342-258 HUMAN PRESCRIPTION DRUG oseltamavir phosphate oseltamavir phosphate CAPSULE ORAL 20170921 ANDA ANDA207211 Macleods Pharmaceuticals Limited OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 33342-260_56327e32-3b06-4144-91a0-bb1908842e33 33342-260 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET ORAL 20170606 ANDA ANDA207210 Macleods Pharmaceuticals Limited ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 33342-276_7ae60119-e22c-4806-a5d8-db7c9e8984a2 33342-276 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin TABLET, EXTENDED RELEASE ORAL 20170729 ANDA ANDA207302 Macleods Pharmaceuticals Limited DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 33342-277_7ae60119-e22c-4806-a5d8-db7c9e8984a2 33342-277 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin TABLET, EXTENDED RELEASE ORAL 20170729 ANDA ANDA207302 Macleods Pharmaceuticals Limited DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 33342-297_f835d9bd-d7f0-463d-a44b-44cd317c7066 33342-297 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20151012 ANDA ANDA202840 Macleods Pharmaceuticals Limited MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 33342-298_f835d9bd-d7f0-463d-a44b-44cd317c7066 33342-298 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20151012 ANDA ANDA202840 Macleods Pharmaceuticals Limited MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 33342-299_9efdf5f2-92f1-422e-9524-5860176b9e3a 33342-299 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Macleods Pharmaceuticals Limited ESZOPICLONE 1 mg/1 CIV N 20181231 33342-300_9efdf5f2-92f1-422e-9524-5860176b9e3a 33342-300 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Macleods Pharmaceuticals Limited ESZOPICLONE 2 mg/1 CIV N 20181231 33342-301_9efdf5f2-92f1-422e-9524-5860176b9e3a 33342-301 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Macleods Pharmaceuticals Limited ESZOPICLONE 3 mg/1 CIV N 20181231 33342-321_5ad9c808-6095-4d86-b140-e0f6d4079a3a 33342-321 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SOLUTION TOPICAL 20171104 ANDA ANDA209361 Macleods Pharmaceuticals Limited CLOBETASOL PROPIONATE .4625 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 33344-001_85d1a81c-3921-4a54-91cb-85cc9739d173 33344-001 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19711101 UNAPPROVED MEDICAL GAS Welding & Therapy Service Inc. NITROGEN 99 L/100L E 20171231 33344-002_b5af3d42-2c1d-44da-9fff-1faeb10a286d 33344-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen LIQUID RESPIRATORY (INHALATION) 19721101 UNAPPROVED MEDICAL GAS Welding & Therapy Service Inc. NITROGEN 99 L/100L E 20171231 33344-003_a7819865-1852-46db-bbdb-75346d5339ec 33344-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19711101 UNAPPROVED MEDICAL GAS Welding & Therapy Service, Inc NITROUS OXIDE 99 L/100L E 20171231 33344-004_7c8f7ec7-c0c5-4be7-a0ed-86ec81bedc53 33344-004 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide LIQUID RESPIRATORY (INHALATION) 19711101 UNAPPROVED MEDICAL GAS Welding & Therapy Service Inc. NITROUS OXIDE 99 L/100L E 20171231 33344-005_c8fb0e08-185b-4446-92ed-364009e0fee8 33344-005 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19711101 UNAPPROVED MEDICAL GAS Welding & Therapy Service Inc. OXYGEN 99 L/100L E 20171231 33344-006_22eb552f-7e4e-400e-859c-41b47361b1b9 33344-006 HUMAN PRESCRIPTION DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 19711101 UNAPPROVED MEDICAL GAS Welding & Therapy Service Inc. OXYGEN 99 L/100L E 20171231 33358-001_4e83e52d-5b25-42b2-8aa7-9d38a2f9901e 33358-001 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 RxChange Co. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 33358-002_2b4756b1-9c97-44b9-b7df-19b88698786a 33358-002 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 20141105 ANDA ANDA089828 RxChange Co. CODEINE PHOSPHATE; ACETAMINOPHEN 60; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 33358-040_f5d68f39-a5e9-48e4-bab6-48b2d928d38f 33358-040 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20141113 ANDA ANDA065404 RxChange Co. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 33358-059_b8de7232-130a-4cd4-adb7-eb6062e634da 33358-059 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20141106 ANDA ANDA200243 RxChange Co. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 33358-064_c1f14976-f6a4-4389-bf36-4f053df760a3 33358-064 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20100701 ANDA ANDA040823 RxChange Co. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 33358-097_03ed81af-b588-41d3-bf01-1667e3d0a0f2 33358-097 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20141106 ANDA ANDA078218 RxChange Co. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 33358-153_35d1a123-17ce-6778-e054-00144ff88e88 33358-153 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20141026 ANDA ANDA078428 RxChange Co. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 33358-154_1b9a1aa4-17bf-4f42-9d84-b9872e9b5c10 33358-154 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20141109 ANDA ANDA202764 RxChange Co. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 33358-187_13171729-20a2-4569-928f-dd38b8eb89dc 33358-187 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20141109 ANDA ANDA090796 RxChange Co. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 33358-188_6c185dc7-5920-4293-b8b4-e090787debae 33358-188 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 RxChange Co. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 33358-211_198f78ce-8573-417c-9a08-1362f731f6f3 33358-211 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20141118 ANDA ANDA077321 RxChange Co. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 33358-212_a4750725-8605-4dd3-a3cf-6eba9d58ae53 33358-212 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 RxChange Co. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 33358-213_3fcdae65-a7fb-4d99-9499-140fdb113a7b 33358-213 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20141112 ANDA ANDA075994 RxChange Co. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 33358-221_600dca46-0151-4959-9891-9a0e54d08a15 33358-221 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20141112 ANDA ANDA076045 RxChange Co. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 33358-251_5663a37f-b62f-4a8b-832a-33f95a4afbdc 33358-251 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20141113 ANDA ANDA078671 RxChange Co. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 33358-252_5663a37f-b62f-4a8b-832a-33f95a4afbdc 33358-252 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20141113 ANDA ANDA078671 RxChange Co. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 33358-259_e68706af-547f-4a60-8dc7-25e8f09e36dd 33358-259 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20141111 ANDA ANDA078432 RxChange Co. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 33358-273_fb542691-0345-4b08-b534-6630f9bbe637 33358-273 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 RxChange Co. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 33358-274_a5aee68e-8dc7-4e03-af71-3a27f7508098 33358-274 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 20141115 ANDA ANDA040284 RxChange Co. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 33358-316_dd0680b7-b318-445a-b849-04b1f75af80a 33358-316 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20141125 ANDA ANDA077824 RxChange Co. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 33358-332_97e69e3c-7c76-459d-882f-327435be01c3 33358-332 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20141115 ANDA ANDA071638 RxChange Co. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 33358-342_6a61c7c9-ac81-463e-9872-0bfff0dbca95 33358-342 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20141114 ANDA ANDA076003 RxChange Co. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV E 20171231 33358-343_18a40110-4a36-442c-b73e-e3d1fd56837d 33358-343 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20141120 ANDA ANDA090485 RxChange Co. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV E 20171231 33358-364_1e1ecdbc-2371-4d40-abfd-eca669ac56a0 33358-364 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 RxChange Co. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 33358-420_94b44ddd-c19c-45d3-a779-be912f8380b3 33358-420 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20141120 ANDA ANDA077903 RxChange Co. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 33358-431_27f2d683-bf04-43f9-b431-2bb80adab6fa 33358-431 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 RxChange Co. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 33358-435_bafeb4a3-63d0-4e8f-a9fa-6c91e5b53925 33358-435 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20141121 ANDA ANDA040526 RxChange Co. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 33358-439_2d3a6610-d79e-44ef-828d-635f445e720b 33358-439 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20141127 ANDA ANDA077903 RxChange Co. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 33358-451_fb0dcb02-f3ac-4d81-9036-3896ea929348 33358-451 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141126 NDA AUTHORIZED GENERIC NDA020254 RxChange Co. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 33358-475_a9f2a4b4-a4f4-4cad-a464-3967d49dd81e 33358-475 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20141127 ANDA ANDA078155 RxChange Co. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 33358-498_ab995edd-8c46-43f0-8698-9e5fb576529c 33358-498 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20141126 ANDA ANDA090469 RxChange Co. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 33358-512_355a69d9-5b4d-4d6c-be1c-213b9e0ad096 33358-512 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20141202 ANDA ANDA090469 RxChange Co. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 33358-530_fa6804d6-91e4-404c-8237-cbc28e327ebb 33358-530 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141127 ANDA ANDA076565 RxChange Co. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 33358-536_d301ae01-f87f-4da5-9578-501702be489f 33358-536 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071221 ANDA ANDA077056 RxChange Co. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 33358-901_72035ad0-7153-4429-839c-5c04d5742fd1 33358-901 HUMAN OTC DRUG Avalin External Analgesic Patch LIDOCAINE, MENTHOL PATCH TOPICAL 20150129 OTC MONOGRAPH NOT FINAL part348 RxChange Co. LIDOCAINE; MENTHOL 40; 10 mg/g; mg/g E 20171231 33358-902_2ebb850f-d998-06ea-e054-00144ff8d46c 33358-902 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 RxChange Co. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 33358-903_3c02f4fb-2d20-3529-e054-00144ff88e88 33358-903 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20010725 ANDA ANDA075671 Rxchange Co MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 33395-875_143d05a9-2909-4871-b939-f4b8a4aa24d5 33395-875 HUMAN OTC DRUG Pic N Shovel Antiseptic Hand and Body Wash 6875 CHLOROXYLENOL SOAP TOPICAL 20170215 OTC MONOGRAPH NOT FINAL part333E All Source Industrial Supply, Inc CHLOROXYLENOL 3 mg/mL N 20181231 33758-001_43419376-723c-410b-abad-08f628f07008 33758-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19720601 NDA NDA205889 Modern Supply Company, Inc. OXYGEN 990 mL/L N 20181231 33992-0016_8f7ffe20-6e80-4616-8711-3cebf63850dc 33992-0016 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20140930 OTC MONOGRAPH NOT FINAL part343 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN 500 mg/1 N 20181231 33992-0029_5b553feb-1fd3-47c6-8a5d-41684854ffce 33992-0029 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20140731 OTC MONOGRAPH NOT FINAL part334 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 33992-0054_b6724541-f874-43a6-a7da-334f73b53f72 33992-0054 HUMAN OTC DRUG XtraCare Skin Relief Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20140519 OTC MONOGRAPH FINAL part347 Greenbrier International DIMETHICONE 5 mg/354mg N 20181231 33992-0055_5a3f9db3-e44b-4925-829a-ebe9b8e1ade3 33992-0055 HUMAN OTC DRUG Daily Moisturizing - Oatmeal Dimethicone LOTION TOPICAL 20140519 OTC MONOGRAPH FINAL part347 Greenbrier International DIMETHICONE 3 g/227g N 20181231 33992-0057_5f100b27-d484-514d-e053-2991aa0a0dd2 33992-0057 HUMAN OTC DRUG Skin Relief Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20171128 OTC MONOGRAPH FINAL part347 Greenbrier International DIMETHICONE 5 mg/354mg N 20181231 33992-0058_6321caf7-8628-f260-e053-2991aa0aaf4e 33992-0058 HUMAN OTC DRUG Skin Relief Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20180102 OTC MONOGRAPH FINAL part347 Greenbrier International DIMETHICONE 5 mg/354mg N 20191231 33992-0072_3dbddf1d-12b9-4c02-9662-0113ab6304bc 33992-0072 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20090512 OTC MONOGRAPH NOT FINAL part356 GREENBRIER INTERNATIONAL, INC. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 33992-0100_04aead72-c449-4fef-bd39-d56ed1037166 33992-0100 HUMAN OTC DRUG Antibacterial Hand TRICLOSAN SOAP TOPICAL 20121205 OTC MONOGRAPH FINAL part333E Greenbrier International, Inc. TRICLOSAN 1.5 mg/mL E 20171231 33992-0107_8feff52b-dba3-4b91-bc3b-6be58e8c2ae1 33992-0107 HUMAN OTC DRUG Mucus Relief Expectorant Guaifenesin TABLET ORAL 20130416 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) GUAIFENESIN 400 mg/1 N 20181231 33992-0109_58ee4ba9-a7d4-4786-9721-2fa24468ed15 33992-0109 HUMAN OTC DRUG Mucus Relief DM Expectorant and Cough Suppressant Dextromethorphan Hydrobromide and Guaifenesin TABLET, COATED ORAL 20100106 20180430 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 33992-0113_d5b412b4-9121-42e0-8c3f-413810ade6dd 33992-0113 HUMAN OTC DRUG Assured Gas Relief Extra Strength Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20120106 OTC MONOGRAPH FINAL part332 Greenbrier International, Inc. DIMETHICONE 125 mg/1 N 20181231 33992-0128_7a6d1cc4-509b-4941-b1e7-6017a4f516bf 33992-0128 HUMAN OTC DRUG All Day Allergy Relief Cetirizine HCl TABLET ORAL 20121019 ANDA ANDA078427 ASSURED (Greenbrier International, Inc.) CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 33992-0129_99132b29-974e-40ae-85c5-5ae577c10378 33992-0129 HUMAN OTC DRUG All Day Allergy Relief Cetirizine HCl TABLET ORAL 20100706 ANDA ANDA078780 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 33992-0157_3a848d85-4778-4426-bd44-3f3465063cde 33992-0157 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 20190708 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ASPIRIN 325 mg/1 E 20171231 33992-0159_a25ac2db-18d6-4ad1-848b-f915304d061b 33992-0159 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 33992-0175_fa229573-fdd3-4809-8fe3-7a407519f747 33992-0175 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN 500 mg/1 N 20181231 33992-0183_04935841-6456-456a-938f-406608df759a 33992-0183 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine, Pyrilamine maleate TABLET ORAL 20140131 OTC MONOGRAPH NOT FINAL part343 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 33992-0199_0f8f8972-b694-49dd-b77d-ad74d442e6a7 33992-0199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20171031 ANDA ANDA078682 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) IBUPROFEN 200 mg/1 N 20181231 33992-0209_47bbbf7a-b909-434a-b745-e5b7dc6dc26a 33992-0209 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20160731 ANDA ANDA076460 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) IBUPROFEN 200 mg/1 N 20181231 33992-0211_15d6513f-004f-433b-bcda-469b85be7c9c 33992-0211 HUMAN OTC DRUG Isopropyl Alcohol ISOPROPYL ALCOHOL SOLUTION TOPICAL 20040811 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ISOPROPYL ALCOHOL 462 mg/mL N 20181231 33992-0213_ef4f5bfb-5425-469f-ae97-0e38edef48a1 33992-0213 HUMAN OTC DRUG Pain Relief PM Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20131130 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 33992-0218_c952d523-5ee6-4f5e-9587-587d22e47328 33992-0218 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ASPIRIN 81 mg/1 N 20191231 33992-0249_013a65ae-875a-4a88-94ae-0bf225211d95 33992-0249 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 20191209 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ASPIRIN 325 mg/1 N 20181231 33992-0268_903fef50-8dc1-4d8f-a4d9-8f6fdfb5e705 33992-0268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part356 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 33992-0271_22c65a8e-37bb-49c9-93a8-ad69ec4560ac 33992-0271 HUMAN OTC DRUG Isopropyl alcohol 50 percent Isopropyl alcohol LIQUID TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part333A ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 33992-0282_37826e57-95e8-4dcc-a493-be7fce2208cf 33992-0282 HUMAN OTC DRUG Pain Relief Childrens Acetaminophen SUSPENSION ORAL 20160630 OTC MONOGRAPH NOT FINAL part343 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN 160 mg/5mL N 20181231 33992-0291_61283452-4f00-4dda-a18a-bd1be02cee5f 33992-0291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 GREENBRIER INTERNATIONAL, INC. IBUPROFEN 200 mg/1 N 20181231 33992-0292_5531a944-c330-4916-b4cc-257cb4d3a59e 33992-0292 HUMAN OTC DRUG Allergy Relief Childrens Diphenhydramine Hydrochloride LIQUID ORAL 20160630 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 33992-0293_27e8ccf7-94cf-4f97-89f7-e3eb18752fba 33992-0293 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20040408 20180609 OTC MONOGRAPH FINAL part338 GREENBRIER INTERNATIONAL, INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 E 20171231 33992-0298_0720a50c-7d05-43e1-a7ff-0703ed649a04 33992-0298 HUMAN OTC DRUG Natural Laxative Sennosides TABLET, FILM COATED ORAL 19950127 20190708 OTC MONOGRAPH NOT FINAL part334 GREENBRIER INTERNATIONAL, INC. SENNOSIDES 8.6 mg/1 E 20171231 33992-0299_ebaabf47-deb0-454e-aa10-89604e3f3985 33992-0299 HUMAN OTC DRUG Multi-Action Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20170209 OTC MONOGRAPH NOT FINAL part356 Greenbrier International, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 33992-0315_41702b1a-eefa-4f1d-b9bb-9f280c8f1bd2 33992-0315 HUMAN OTC DRUG ASSURED Foaming Hand Sanitizer Benzalkonium chloride LIQUID TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part333A Greenbrier International Inc BENZALKONIUM CHLORIDE .13 g/100mL E 20171231 33992-0318_1340ac20-79fb-4632-8d46-6fcba90cb7f2 33992-0318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 20170209 OTC MONOGRAPH NOT FINAL part356 GREENBRIER INTERNATIONAL, INC. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 33992-0319_ae21a785-75eb-4999-9dc1-d8a62456eeda 33992-0319 HUMAN OTC DRUG Stomach Relief Multi-Symptom Bismuth subsalicylate TABLET, CHEWABLE ORAL 19980716 20190708 OTC MONOGRAPH FINAL part335 GREENBRIER INTERNATIONAL, INC. BISMUTH SUBSALICYLATE 262 mg/1 E 20171231 33992-0327_d716559d-3124-4db2-b4b0-51eb856c1328 33992-0327 HUMAN OTC DRUG Laxative Bisacodyl TABLET, SUGAR COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 GREENBRIER INTERNATIONAL, INC. BISACODYL 5 mg/1 N 20191231 33992-0329_22702f1b-968e-4729-b20b-5ba344e8799d 33992-0329 HUMAN OTC DRUG Allergy Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 33992-0344_62851a35-f5e0-4ab3-ac3b-231d4d1d482e 33992-0344 HUMAN OTC DRUG Cold and Flu Relief Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20171031 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 33992-0367_628e360a-bc30-4a2a-8c8d-0333a73d14ea 33992-0367 HUMAN OTC DRUG Sleep Aid Nighttime Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 GREENBRIER INTERNATIONAL, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 33992-0372_f93233a8-c719-4176-a66e-88ab0f5c630f 33992-0372 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20160430 OTC MONOGRAPH FINAL part335 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 33992-0373_9bb9a045-32d2-4ae9-ac0d-7eb5a1c69b74 33992-0373 HUMAN OTC DRUG Headache PM Aspirin Free Acetaminophen and Diphenhydramine Citrate TABLET, FILM COATED ORAL 20040607 20200217 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 N 20181231 33992-0375_91bc6400-f1fe-4af0-bc98-f2765b42b9e9 33992-0375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 GREENBRIER INTERNATIONAL, INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 33992-0379_56b43543-8938-4405-bd4d-0429941b6822 33992-0379 HUMAN OTC DRUG NightTime Cold and Cough Children Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20170831 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 33992-0385_74367c8e-b840-494e-8d99-95b2803782ac 33992-0385 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20160430 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 33992-0389_88ecf89d-efbb-4d2d-b71e-8c6c6b343be8 33992-0389 HUMAN OTC DRUG Tussin Mucus and Chest Congestion Guaifenesin LIQUID ORAL 20160430 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) GUAIFENESIN 200 mg/10mL N 20181231 33992-0393_1678621b-ea60-4a81-9443-f5fa9e67f3ad 33992-0393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 GREENBRIER INTERNATIONAL, INC. IBUPROFEN 200 mg/1 N 20181231 33992-0403_6739d9b1-adc1-43dc-af92-bc215d8aacbc 33992-0403 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 20190708 OTC MONOGRAPH FINAL part336 GREENBRIER INTERNATIONAL, INC. MECLIZINE HYDROCHLORIDE 25 mg/1 E 20171231 33992-0404_bee2b4eb-7b2d-4a09-b8be-bbe979848103 33992-0404 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20170531 OTC MONOGRAPH FINAL part338 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 33992-0413_dcf3f104-87a2-49aa-8f3a-88b1b5205ede 33992-0413 HUMAN OTC DRUG Back and Body Extra Strength Aspirin, Caffeine TABLET ORAL 20040412 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 N 20181231 33992-0428_49e22ccb-eee4-460d-9bae-89765239ab47 33992-0428 HUMAN OTC DRUG Tension Headache Relief Acetaminophen, Caffeine TABLET ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 33992-0447_37c3ba32-1c19-42a7-bed5-a58a697a69c6 33992-0447 HUMAN OTC DRUG Pain Relief PM Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20141130 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 33992-0453_1c6aaa61-64ae-4c47-b82c-289cd253d750 33992-0453 HUMAN OTC DRUG Nasal Decongestant Non-Drowsy Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20191231 33992-0464_c04c69ed-edd4-4395-832d-9560e149dbb4 33992-0464 HUMAN OTC DRUG Allergy Plus Sinus Headache Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED ORAL 20050615 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 33992-0468_c69fd0c9-c5b0-4085-b189-ff9c2826d928 33992-0468 HUMAN OTC DRUG DayTime Multi-Symptom ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20170531 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 33992-0471_810e2aa6-d528-4726-bad5-bda7b89d5d69 33992-0471 HUMAN OTC DRUG Night Time Cold and Flu Relief Multi Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20160731 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 33992-0472_106b6e1b-8079-42e0-8cb2-16a8ad2d1392 33992-0472 HUMAN OTC DRUG Daytime Nighttime Cold and Flu Relief Multi-Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20170531 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) N 20181231 33992-0503_28c5b717-29ea-4cbe-8dbf-d371cbcc9b0f 33992-0503 HUMAN OTC DRUG Cold Multi-Symptom Severe Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guaifenesin TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 33992-0519_93766e21-0dd9-4c1d-8c78-1be87f02e792 33992-0519 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN 500 mg/1 N 20181231 33992-0520_d670f665-d053-498c-91ab-11b589fb37c5 33992-0520 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl CAPSULE, LIQUID FILLED ORAL 20131120 NDA NDA021855 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 33992-0527_9d51fd63-2a2a-4390-8918-4a0b2376456f 33992-0527 HUMAN OTC DRUG Severe Sinus Congestion and Pain Daytime Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 33992-0529_264ced03-317c-4d24-8c04-97e5ab72c934 33992-0529 HUMAN OTC DRUG Cold Formula Daytime Nighttime, Non-Aspirin, Multi-Symptom Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. N 20181231 33992-0568_7d219dda-047a-4785-a28b-8396821f36cf 33992-0568 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20161231 ANDA ANDA079174 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) IBUPROFEN 200 mg/1 N 20181231 33992-0574_605cd01f-9ac9-0e53-e053-2991aa0a75b9 33992-0574 HUMAN OTC DRUG ASSURED VAPORIZING CHEST RUB menthol, camphor, eucalyptus oil ointment GEL TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part348 GREENBRIER INTERNATIONAL, INC. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1; 1 g/100g; g/100g; g/100g N 20181231 33992-0608_1ae27047-8ceb-4fc8-bc78-a2c07a2a6c31 33992-0608 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone TABLET, CHEWABLE ORAL 20130701 20190708 OTC MONOGRAPH FINAL part332 GREENBRIER INTERNATIONAL, INC. DIMETHICONE 125 mg/1 E 20171231 33992-0611_6cf1fd3d-5529-412d-9003-a06edd445f57 33992-0611 HUMAN OTC DRUG Daytime Multi-Symptom Cold/Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130201 OTC MONOGRAPH FINAL part341 Greenbrier International ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 33992-0612_1ccd9088-2c59-4a0f-a46b-4b3bddd3e901 33992-0612 HUMAN OTC DRUG Assured Allergy Relief Loratadine TABLET ORAL 20170731 ANDA ANDA076301 Greenbrier International Inc. LORATADINE 10 mg/1 N 20181231 33992-0620_99ab4cbd-414b-4b78-bbb1-b2ba53e0a385 33992-0620 HUMAN OTC DRUG Heartburn Relief Maximum Strength Ranitidine TABLET, FILM COATED ORAL 20130615 20180715 ANDA ANDA200536 GREENBRIER INTERNATIONAL, INC. RANITIDINE HYDROCHLORIDE 150 mg/1 E 20171231 33992-0621_e278b8ad-2eb0-4bd8-a455-a8a438e87f97 33992-0621 HUMAN OTC DRUG NiteTime Multi-Symptom Cold/Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130104 OTC MONOGRAPH FINAL part341 Greenbrier International ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 33992-0656_91f486a9-b67a-4e92-ad18-22fef89b7827 33992-0656 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part338 GREENBRIER INTERNATIONAL, INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 33992-0664_a749bab6-727f-413e-8d3f-67897c013238 33992-0664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20161221 OTC MONOGRAPH NOT FINAL part356 Greenbrier International, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 33992-0666_e23c9a49-d972-49be-9c13-6eef06114ec0 33992-0666 HUMAN OTC DRUG Cough Relief Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20170630 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 33992-0676_17cfab46-7dd3-4bf3-8ef5-b6a1865d1b95 33992-0676 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET, COATED ORAL 20150916 20190708 OTC MONOGRAPH NOT FINAL part334 GREENBRIER INTERNATIONAL, INC. BISACODYL 5 mg/1 E 20171231 33992-0700_4688a1ed-9cd5-37a1-e054-00144ff8d46c 33992-0700 HUMAN OTC DRUG Assured Pyrithione Zinc SHAMPOO TOPICAL 20170119 OTC MONOGRAPH FINAL part358H Greenbrier International Inc. PYRITHIONE ZINC 1 g/100mL N 20181231 33992-0822_89712b0a-a6af-4934-aeaf-f402c0519a98 33992-0822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20160623 OTC MONOGRAPH FINAL part347 Greenbrier International, Inc WITCH HAZEL 841 mg/mL N 20181231 33992-0828_6d3d1a6e-8a58-437d-b7a7-2d1b486a141c 33992-0828 HUMAN OTC DRUG Assured ALUMINUM SULFATE POWDER TOPICAL 20160420 OTC MONOGRAPH FINAL part347 Greenbrier International ALUMINUM SULFATE 56 g/100g E 20171231 33992-0864_e5ad4ef1-e0d9-4caa-ae97-7eb22b11bdf4 33992-0864 HUMAN OTC DRUG 50% Rubbing Isopropyl Alcohol LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ISOPROPYL ALCOHOL 500 mg/mL N 20181231 33992-0871_5e55dcfc-7482-46b1-88b7-366074781427 33992-0871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20090512 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc HYDROGEN PEROXIDE 30 mg/mL N 20181231 33992-1001_48078234-d8f9-546e-e054-00144ff8d46c 33992-1001 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20131118 OTC MONOGRAPH FINAL part341 Greenbrier International MENTHOL 5.4 mg/1 N 20181231 33992-1002_486c83f6-cae3-50f2-e054-00144ff8d46c 33992-1002 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20140326 OTC MONOGRAPH FINAL part341 Greenbrier International MENTHOL 5.8 mg/1 N 20181231 33992-1003_486e56f7-3ed9-490e-e054-00144ff8d46c 33992-1003 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20130619 OTC MONOGRAPH FINAL part341 Greenbrier International MENTHOL 7.5 mg/1 N 20181231 33992-1004_486e8410-322a-6cb7-e054-00144ff88e88 33992-1004 HUMAN OTC DRUG Strawberry Cough Drop Menthol LOZENGE ORAL 20140608 OTC MONOGRAPH FINAL part341 Greenbrier International Inc. MENTHOL 2.7 mg/1 N 20181231 33992-1005_486f11d3-8e6c-692a-e054-00144ff8d46c 33992-1005 HUMAN OTC DRUG Herbal Cough Drop Menthol LOZENGE ORAL 20140708 OTC MONOGRAPH FINAL part341 Greenbrier International Inc. MENTHOL 4.8 mg/1 N 20181231 33992-1006_486f7a5b-9498-06e7-e054-00144ff8d46c 33992-1006 HUMAN OTC DRUG SF Menthol Cough Drop Menthol LOZENGE ORAL 20140602 OTC MONOGRAPH FINAL part341 Greenbrier International Inc. MENTHOL 5.8 mg/1 N 20181231 33992-1007_486f6043-e8a2-06e9-e054-00144ff8d46c 33992-1007 HUMAN OTC DRUG SF Honey Lemon Cough Drop Menthol LOZENGE ORAL 20140326 OTC MONOGRAPH FINAL part341 Greenbrier International Inc. MENTHOL 7.6 mg/1 N 20181231 33992-1009_4ab61c3d-dff1-49c8-e054-00144ff8d46c 33992-1009 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20160113 OTC MONOGRAPH FINAL part341 Greenbrier International Inc. MENTHOL 7.5 mg/1 N 20181231 33992-1010_5fc3a067-e417-63f1-e053-2a91aa0ae62c 33992-1010 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20171207 OTC MONOGRAPH FINAL part341 Greenbrier International Inc. MENTHOL 5.4 mg/1 N 20181231 33992-1011_5fc44bc8-f9ce-3581-e053-2991aa0ad1c6 33992-1011 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20171207 OTC MONOGRAPH FINAL part341 Greenbrier International Inc. MENTHOL 5.8 mg/1 N 20181231 33992-1012_5fc55c02-14b5-3650-e053-2a91aa0ae671 33992-1012 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20171207 OTC MONOGRAPH FINAL part341 Greenbrier International Inc. MENTHOL 7.5 mg/1 N 20181231 33992-1013_5fc5f01f-17be-26c1-e053-2991aa0a0ca4 33992-1013 HUMAN OTC DRUG strawberry cough drops menthol LOZENGE ORAL 20171207 OTC MONOGRAPH FINAL part341 Greenbrier International Inc. MENTHOL 2.7 mg/1 N 20181231 33992-1014_5fd98eab-e62d-8ea7-e053-2991aa0a12c2 33992-1014 HUMAN OTC DRUG Herbal cough drops Menthol LOZENGE ORAL 20171208 OTC MONOGRAPH FINAL part341 Greenbrier International Inc. MENTHOL 4.8 mg/1 N 20181231 33992-1015_5fc69acb-7720-c7ba-e053-2991aa0a5a26 33992-1015 HUMAN OTC DRUG sugar free menthol cough drops Menthol LOZENGE ORAL 20171207 OTC MONOGRAPH FINAL part341 Greenbrier International Inc. MENTHOL 5.8 mg/1 N 20181231 33992-1016_5fc7348d-daf5-47cf-e053-2991aa0aa101 33992-1016 HUMAN OTC DRUG sugar free honey lemon cough drops menthol LOZENGE ORAL 20171207 OTC MONOGRAPH FINAL part341 Greenbrier International Inc. MENTHOL 7.6 mg/1 N 20181231 33992-1060_177ce39f-ef06-4e6d-8c1f-75284d0ea00e 33992-1060 HUMAN OTC DRUG INSTANT Hand Sanitizer Extra Enriched With Vitamin E Lemon Fresh Scent ALCOHOL GEL TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-1061_4790b95f-950a-46c3-836a-c93c894ccaab 33992-1061 HUMAN OTC DRUG ASSURED Instant Hand Sanitizer WITH MOISTURIZERS Aloe Vera and Moisturizers ALCOHOL GEL TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-1062_1a7d9da9-18db-4e8d-bc50-90fa89170c49 33992-1062 HUMAN OTC DRUG INSTANT Hand Sanitizer Extra Enriched With Vitamin E Lemon Fresh Scent ALCOHOL GEL TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-1063_a8294a9c-fd53-4e87-a04f-2806d09a4742 33992-1063 HUMAN OTC DRUG Assured Instant Hand Sanitizer with Moisturizers Vitamin E and Aloe ALCOHOL GEL TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-1066_65647d87-9b07-4075-851f-d231f307d145 33992-1066 HUMAN OTC DRUG INSTANT Hand Sanitizer Extra Enriched With Vitamin E Strawberry Scent ALCOHOL GEL TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-1067_ef045c61-f212-40fa-877e-fb2a32c22f28 33992-1067 HUMAN OTC DRUG INSTANT Hand Sanitizer Extra Enriched With Vitamin E Vanilla Scent ALCOHOL GEL TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-1068_2e664fd4-5a1d-44d5-ac06-b206a6508381 33992-1068 HUMAN OTC DRUG Assured Aloe Scented Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-1069_b5ace107-3c57-4ea9-935b-87c26736e5a1 33992-1069 HUMAN OTC DRUG INSTANT Hand Sanitizer with Moisturizers All In One ALCOHOL GEL TOPICAL 20110805 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-1070_53b8d261-f8ee-4932-8905-522be7a6163a 33992-1070 HUMAN OTC DRUG Assured Instant Hand Sanitizer Alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-1071_2b5aae41-d1d4-400d-8c72-d563c630f6b8 33992-1071 HUMAN OTC DRUG ASSURED Instant Hand Sanitizer WITH MOISTURIZERS Vitamin E and Aloe ALCOHOL GEL TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-1071_d48977d9-01ae-41b5-a2bc-3892a0cc3eb1 33992-1071 HUMAN OTC DRUG Assured Instant Hand Sanitizer With Moisturizers Vitamin E and Aloe Alcohol GEL TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-1075_f634ea1c-817f-4958-b188-f4beda3c9042 33992-1075 HUMAN OTC DRUG Assured Instant Hand Sanitizer Alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-1080_4eeada69-9099-46dd-809e-7b4214f0b0c4 33992-1080 HUMAN OTC DRUG Assured Hand Sanitizer With Moisturizers ALCOHOL GEL TOPICAL 20100506 OTC MONOGRAPH FINAL part333 Greenbrier International, Inc ALCOHOL 62 mL/100mL E 20171231 33992-1100_e6eebf85-48bf-453d-9f8d-0f13074d0807 33992-1100 HUMAN OTC DRUG Daytime Sinus Relief Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20131209 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 33992-1108_abe4d54d-b026-45d0-beda-2f36ffa0c4bd 33992-1108 HUMAN OTC DRUG Cocoa Butter Petrolatum LOTION TOPICAL 20110802 OTC MONOGRAPH FINAL part347 GREENBRIER INTERNATIONAL PETROLATUM 5 g/100g N 20181231 33992-1129_beca4704-56ec-4d40-8daf-fc4d96a29e10 33992-1129 HUMAN OTC DRUG Oatmeal dimethicone LOTION TOPICAL 20111206 OTC MONOGRAPH FINAL part347 GREENBRIER INTERNATIONAL DIMETHICONE .15 g/100g N 20181231 33992-1130_b4f420a8-9123-4fba-8440-caa501ad370d 33992-1130 HUMAN OTC DRUG anti-dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20111206 OTC MONOGRAPH FINAL part358H GREENBRIER INTERNATIONAL PYRITHIONE ZINC .05 g/100g N 20181231 33992-1131_71965ff5-d37c-4908-8c3c-e3041581ae33 33992-1131 HUMAN OTC DRUG Hair and Scalp anti-dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20130508 OTC MONOGRAPH FINAL part358H GREENBRIER INTERNATIONAL PYRITHIONE ZINC 1 g/100mL N 20181231 33992-1136_d85735b7-7a77-42df-8fb1-9fefb8aaa791 33992-1136 HUMAN OTC DRUG Assured Muscle Rub Menthol GEL TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. MENTHOL, UNSPECIFIED FORM 2.5 g/100g N 20181231 33992-1200_102d4516-634f-4785-9af1-7a4233ebfb0a 33992-1200 HUMAN OTC DRUG CREAMY PETROLEUM JELLY VITAMIN E ENRICHED PETROLATUM CREAM TOPICAL 20100818 OTC MONOGRAPH FINAL part347 GREENBRIER INTERNATIONAL PETROLATUM 30 g/100g E 20171231 33992-1201_06347d34-dbc3-475d-8acd-4281ccbaec46 33992-1201 HUMAN OTC DRUG Cucumber Melon Scented Hand Sanitizer Alcohol GEL TOPICAL 20120315 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1202_65838285-ea10-4893-a5c7-cb37c093a765 33992-1202 HUMAN OTC DRUG Irresistible Apple Scented Hand Sanitizer Alcohol GEL TOPICAL 20120315 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1203_98dfac3e-4231-4408-9945-914f8f8b9ce7 33992-1203 HUMAN OTC DRUG Orange Scented Hand Sanitizer Alcohol GEL TOPICAL 20120315 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1204_26dff989-3f42-4c09-a7a5-d21770c848ad 33992-1204 HUMAN OTC DRUG Pomegranate Scented Hand Sanitizer Alcohol GEL TOPICAL 20120315 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1205_b1865156-6016-410e-b580-43c6eafd9620 33992-1205 HUMAN OTC DRUG Ocean Breeze Scented Hand Sanitizer Alcohol GEL TOPICAL 20120315 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1206_0985b9a9-26b9-40bb-aca0-b4eeb5d0724a 33992-1206 HUMAN OTC DRUG Lemon Scented Hand Sanitizer Alcohol GEL TOPICAL 20120315 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1210_22a63c74-80fa-4f0b-b57d-e0f14c9ee760 33992-1210 HUMAN OTC DRUG Assured CREAMY PETROLEUM JELLY VITAMIN E ENRICHED PETROLATUM CREAM TOPICAL 20130425 OTC MONOGRAPH FINAL part347 GREENBRIER INTERNATIONAL PETROLATUM 30 g/100g N 20181231 33992-1300_80a24bd9-1dcb-4e4c-ad47-1c58b7f284bc 33992-1300 HUMAN OTC DRUG Creamy Cocoa Butter Petroleum PETROLATUM JELLY TOPICAL 20100818 OTC MONOGRAPH FINAL part347 GREENBRIER INTERNATIONAL PETROLATUM 30 g/100g E 20171231 33992-1306_c67b9ae5-feb9-461b-b4b9-9474f7ebc28d 33992-1306 HUMAN OTC DRUG BABYS BUTT AID ZINC OXIDE OINTMENT TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 GREENBRIER INTERNATIONAL INC ZINC OXIDE 16 g/100g E 20171231 33992-1307_8c93f61f-6598-4554-ba46-6ef7c8421a14 33992-1307 HUMAN OTC DRUG ACNE SALICYLIC ACID CREAM TOPICAL 20130101 OTC MONOGRAPH FINAL part358H GREENBRIER INTERNATIONAL INC SALICYLIC ACID 14 g/100g E 20171231 33992-1310_cd8ee2a9-9f7b-4271-80a3-ab0b2257bce7 33992-1310 HUMAN OTC DRUG Assured Creamy Cocoa Butter Petroleum Vitamin E Enriched PETROLATUM JELLY TOPICAL 20130425 OTC MONOGRAPH FINAL part347 GREENBRIER INTERNATIONAL PETROLATUM 30 g/100g N 20181231 33992-1400_6abb0e15-f193-46d9-b4a1-8edc3a28f3c9 33992-1400 HUMAN OTC DRUG 3 Hand Sanitizers ALCOHOL KIT TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. N 20181231 33992-1401_0e2420c0-9108-4dc2-97a8-7c58401e0fa7 33992-1401 HUMAN OTC DRUG Instant Hand Sanitizer Extra Enriched With Vitamin E Bead Strawberry Scent Alcohol GEL TOPICAL 20120510 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1402_b2963601-1d4a-4321-8862-03eafa043966 33992-1402 HUMAN OTC DRUG Instant Hand Sanitizer Extra Enriched With Vitamin E Bead Lemon Fresh Scent Alcohol GEL TOPICAL 20120510 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1403_9dd56ea5-656d-494a-8037-1c3b986c1fb8 33992-1403 HUMAN OTC DRUG Instant Hand Sanitizer Extra Enriched With Vitamin E Bead Vanilla Scent Alcohol GEL TOPICAL 20120510 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1410_f3484622-6425-44a5-bce7-ba246ac95d5b 33992-1410 HUMAN OTC DRUG Instant Hand Sanitizer With Moisturizers Alcohol GEL TOPICAL 20121113 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1411_24c01a03-2710-4489-9ab6-c5d43c6349f2 33992-1411 HUMAN OTC DRUG Instant Hand Sanitizer With Moisturizers (Vitamin E and Aloe) Alcohol GEL TOPICAL 20121113 OTC MONOGRAPH FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1411_3d6c1ec3-b9d0-418c-8515-2bd4a59ba0c3 33992-1411 HUMAN OTC DRUG Instant Hand Sanitizer with moisturizers (Vitamin E and aloe) ALCOHOL GEL TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1412_9fbc5424-5dd8-42ad-90e2-d4b225ca5be5 33992-1412 HUMAN OTC DRUG Instant Hand Sanitizer with moisturizers (aloe vera and moisturizers) ALCOHOL GEL TOPICAL 20130622 OTC MONOGRAPH NOT FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1413_911f769d-6373-4fab-845b-c1bc935c9099 33992-1413 HUMAN OTC DRUG Hand Cleanse Triclosan GEL TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN .15 mg/mL N 20181231 33992-1415_71262433-52f7-4209-bd54-3ec47e7b0c0b 33992-1415 HUMAN OTC DRUG 2 Pack Assured Instant Hand Sanitizer with moisturizers (Vitamin E and aloe) ALCOHOL GEL TOPICAL 20130622 OTC MONOGRAPH NOT FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1416_a666bd99-88cc-494a-92d8-e7b73b2b8aa9 33992-1416 HUMAN OTC DRUG 3 Pack Instant Hand Sanitizer with moisturizers ALCOHOL GEL TOPICAL 20130829 OTC MONOGRAPH NOT FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1417_44e146a4-a06a-463a-bc68-4a42c99f57d1 33992-1417 HUMAN OTC DRUG 3 Pack Instant Hand Sanitizer with moisturizers Aloe Scented ALCOHOL GEL TOPICAL 20130829 OTC MONOGRAPH NOT FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1418_d08bbd39-aa61-40d6-acf1-b1a06e6bd048 33992-1418 HUMAN OTC DRUG 3 Pack Instant Hand Sanitizer with moisturizers Lavender Scented ALCOHOL GEL TOPICAL 20130829 OTC MONOGRAPH NOT FINAL part333E Greenbrier International ALCOHOL 62 mL/100mL N 20181231 33992-1419_5fb2b33b-da5d-118b-e053-2991aa0a46bc 33992-1419 HUMAN OTC DRUG simple pleasures ANTIBACTERIAL HAND SANITIZER Ethyl Alcohol LIQUID TOPICAL 20160304 OTC MONOGRAPH NOT FINAL part333A GREENBRIER INTERNATIONAL, INC. ALCOHOL 62 g/100mL N 20181231 33992-1420_5fb2c23c-69e5-1d83-e053-2991aa0aa1bd 33992-1420 HUMAN OTC DRUG simple pleasures ANTIBACTERIAL HAND SANITIZER Ethyl Alcohol LIQUID TOPICAL 20160304 OTC MONOGRAPH NOT FINAL part333A GREENBRIER INTERNATIONAL, INC. ALCOHOL 62 g/100mL N 20181231 33992-1421_5fb290ea-b20b-dd1b-e053-2991aa0a8dab 33992-1421 HUMAN OTC DRUG simple pleasures ANTIBACTERIAL HAND SANITIZER Ethyl Alcohol LIQUID TOPICAL 20160304 OTC MONOGRAPH NOT FINAL part333A GREENBRIER INTERNATIONAL, INC. ALCOHOL 62 g/100mL N 20181231 33992-1422_5fb2a99d-337a-f064-e053-2991aa0a9b1a 33992-1422 HUMAN OTC DRUG simple pleasures ANTIBACTERIAL HAND SANITIZER Ethyl Alcohol LIQUID TOPICAL 20160304 OTC MONOGRAPH NOT FINAL part333A GREENBRIER INTERNATIONAL, INC. ALCOHOL 62 g/100mL N 20181231 33992-1500_5d1d1964-287e-44cc-aefb-0186ea48cc26 33992-1500 HUMAN OTC DRUG 3 HAND SANITIZERS KIT ALCOHOL KIT TOPICAL 20120815 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. N 20181231 33992-1579_a68fda01-375a-4303-8bd5-0cabc8e13183 33992-1579 HUMAN OTC DRUG Antibacterial Hand - Ocean Fresh Scent TRICLOSAN SOAP TOPICAL 20110509 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN .15 mL/100mL E 20171231 33992-1581_4c583cc0-74e5-486e-bfe1-67855e37dbda 33992-1581 HUMAN OTC DRUG Antibacterial Hand - Strawberry Pomegranate Scent TRICLOSAN SOAP TOPICAL 20110509 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN .15 mL/100mL E 20171231 33992-1889_bdfcac69-a9c7-485f-8d70-c765bb8fc1bb 33992-1889 HUMAN OTC DRUG ASSURED PAIN RELIEF HOT PATCH MENTHOL, CAPSICUM OLEORESIN PATCH TOPICAL 20130331 OTC MONOGRAPH NOT FINAL part348 GREENBRIER INTERNATIONAL, INC. MENTHOL; CAPSAICIN 30; 8.3 mg/1; mg/1 N 20181231 33992-2013_3995dad7-8014-675d-e054-00144ff8d46c 33992-2013 HUMAN OTC DRUG Assured Feminine Anti-itch Benzocaine Benzalkonium chloride CREAM TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part348 Greenbrier International BENZOCAINE; BENZALKONIUM CHLORIDE 5; 130 g/100g; mg/100g E 20171231 33992-2014_4c5a257c-51ba-44c9-e054-00144ff88e88 33992-2014 HUMAN OTC DRUG Assured Feminine Anti-itch Benzocaine Resorcinol CREAM TOPICAL 20170331 OTC MONOGRAPH NOT FINAL part348 Greenbrier International BENZOCAINE; RESORCINOL 5; 2 g/100g; g/100g N 20181231 33992-2100_7be45e22-4ccd-4582-a939-3b464bae277e 33992-2100 HUMAN OTC DRUG Antibacterial Moist Wipe BENZALKONIUM CHLORIDE SWAB TOPICAL 20121010 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZALKONIUM CHLORIDE 1 mg/mL E 20171231 33992-2150_ef754139-6376-4c6d-b9a4-bb284a9d1208 33992-2150 HUMAN OTC DRUG Acne Wipes SALICYLIC ACID SWAB TOPICAL 20121211 OTC MONOGRAPH FINAL part333D Greenbrier International, Inc. SALICYLIC ACID 5 mg/mL E 20171231 33992-2261_4ef8fba9-1ad3-4124-ab0a-39db5f64f578 33992-2261 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 GREENBRIER INTERNATIONAL, INC. CAFFEINE 200 mg/1 N 20191231 33992-2270_36f699c7-02ab-464e-b4ac-9e256c6c6e86 33992-2270 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20130331 OTC MONOGRAPH FINAL part343 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) ASPIRIN 81 mg/1 N 20181231 33992-2300_2fe02208-dc55-4086-ac3f-fff1196d2144 33992-2300 HUMAN OTC DRUG Sleep-Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20100706 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 33992-2360_b74d2657-c0c7-4a82-83ed-e9cfd5c37150 33992-2360 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 ASSURED / DOLLAR TREE (Greenbrier International, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 33992-3001_142abc1b-4875-480e-9ded-bb3dec11b3a0 33992-3001 HUMAN OTC DRUG 2-Pack Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 36.7 mL/59.2mL N 20181231 33992-3002_af002259-a5a8-4703-9b61-bf4593f269f7 33992-3002 HUMAN OTC DRUG Sweet Pea Blossom Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 147 mL/237mL N 20181231 33992-3003_e032928d-87d5-49b2-990d-2ada4da5ac53 33992-3003 HUMAN OTC DRUG Cucumber Melon Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 147 mL/237mL N 20181231 33992-3004_4197b5bb-db51-4c34-ba3a-8b618da54dde 33992-3004 HUMAN OTC DRUG Warm Vanilla Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 147 mL/237mL N 20181231 33992-3005_53d3a41f-c439-43ed-a5f6-c59ed1ba346b 33992-3005 HUMAN OTC DRUG Hand Sanitizer with Moisturizers Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 147 mL/237mL N 20181231 33992-3006_2252f85c-2ea9-4912-b36c-e5498db0a8c8 33992-3006 HUMAN OTC DRUG Hand Sanitizer with Moisturizers Vitamin E and Aloe Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 147 mL/237mL N 20181231 33992-3007_e8f23c6d-827a-4106-8a11-3da9b0a148be 33992-3007 HUMAN OTC DRUG Ice Cold Topical Analgesic Gel Menthol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. MENTHOL 2.84 mg/227mg N 20181231 33992-3008_bd638c06-6942-4285-95fc-9c8d1feab991 33992-3008 HUMAN OTC DRUG Hand Cleanse Refill Triclosan GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN 7.5 mg/500mg N 20181231 33992-3009_48242043-5c5f-4ddf-a477-e797a6a6eacf 33992-3009 HUMAN OTC DRUG Hand Cleanse Triclosan GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN 7.5 mg/500mg N 20181231 33992-3010_3bf8eca3-bf47-4b65-8838-7fbb5f6b45fb 33992-3010 HUMAN OTC DRUG Hand Cleanse - Ocean Fresh Triclosan GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN 7.5 mg/500mg N 20181231 33992-3011_ad81fe94-ad57-4456-ba5d-2dc429005de7 33992-3011 HUMAN OTC DRUG Hand Cleanse - Strawberry Pomegranate Triclosan GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. TRICLOSAN 7.5 mg/500mg N 20181231 33992-3012_fd28ac88-be95-4bc2-bc89-8c52c8bd76c9 33992-3012 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-3013_4458549f-8868-42f6-abf4-a0377460a3f7 33992-3013 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-3014_4b6af2fa-35cd-4961-9b19-47305d796185 33992-3014 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-3015_566230b5-ad7e-481f-a987-3ba5e674fd39 33992-3015 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-3016_efb64742-45e3-4402-939d-3a95447350fa 33992-3016 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-3017_74ff4a5e-cb00-498b-8f63-5643709ec7f5 33992-3017 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-3018_b2e3e731-56dd-44c5-8bb8-4c9b92d643fe 33992-3018 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150702 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 g/100g N 20181231 33992-3019_53b366f2-7301-4497-8488-b28a04b48297 33992-3019 HUMAN OTC DRUG Assured Aloe Ethyl Alcohol GEL TOPICAL 20150702 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 g/100g N 20181231 33992-3020_354003ff-4e51-0b93-e054-00144ff88e88 33992-3020 HUMAN OTC DRUG Assured Epsom Salt Magnesium Sulfate GRANULE ORAL 20160614 OTC MONOGRAPH NOT FINAL part334 Greenbrier International, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 100 g/100g E 20171231 33992-3022_4d9d4306-f332-729c-e054-00144ff8d46c 33992-3022 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 70 mL/100mL N 20181231 33992-3023_4d9eb0bb-f6c6-4248-e054-00144ff8d46c 33992-3023 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 70 mL/100mL N 20181231 33992-3024_4d9f04f0-ed5f-5547-e054-00144ff8d46c 33992-3024 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 70 mL/100mL N 20181231 33992-3025_4d9f1c82-919b-337a-e054-00144ff88e88 33992-3025 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 70 mL/100mL N 20181231 33992-3026_4d9f4181-e98d-6157-e054-00144ff8d46c 33992-3026 HUMAN OTC DRUG Assured Aloe Ethyl Alcohol GEL TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 70 mL/100mL N 20181231 33992-3027_5f0da7bf-a3fc-9a1a-e053-2a91aa0aa213 33992-3027 HUMAN OTC DRUG Assured Aloe Ethyl Alcohol GEL TOPICAL 20171128 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 70 mL/100mL N 20181231 33992-3028_61d2c58b-0ce0-d818-e053-2991aa0a28f9 33992-3028 HUMAN OTC DRUG Hand Sanitizer Refill 15 oz Ethyl Alcohol GEL TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 70 mL/100mL N 20191231 33992-3113_b50bc466-9fd3-457c-8c7b-526b17ff8d1a 33992-3113 HUMAN OTC DRUG Extra Strength Gas Relief SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20180119 OTC MONOGRAPH FINAL part332 Greenbrier International, Inc. DIMETHICONE 125 mg/1 N 20181231 33992-4250_3d971bc4-4818-3d10-e054-00144ff88e88 33992-4250 HUMAN OTC DRUG Assured Instant Hand Sanitizer Alcohol SPRAY TOPICAL 20100323 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-4470_82a266ee-3c99-451a-9770-e6f284dfedc7 33992-4470 HUMAN OTC DRUG Childrens Rapid Melts Acetaminophen TABLET, CHEWABLE ORAL 20050203 20190708 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN 80 mg/1 E 20171231 33992-4947_6cf2ac78-393d-4fb7-b76a-d7e7643e50ea 33992-4947 HUMAN OTC DRUG Assured Hand Sanitizer with Vitamin E Ethyl Alcohol LIQUID TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333A Greenbrier International Inc. ALCOHOL 70 mL/100mL E 20171231 33992-4948_bb3e4991-f906-454b-857c-9b5ada6a2e80 33992-4948 HUMAN OTC DRUG Assured Hand Sanitizer with Aloe Vera Ethyl Alcohol LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333A Greenbrier International Inc. ALCOHOL 62 mL/100mL E 20171231 33992-4949_196a6639-566d-4d98-b189-71a06df1a716 33992-4949 HUMAN OTC DRUG Assured Hand Sanitizer with Vitamin E Ethyl Alcohol LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333A Greenbrier International Inc. ALCOHOL 62 mL/100mL E 20171231 33992-4950_3a030012-e019-4230-9150-7c23a6040dcb 33992-4950 HUMAN OTC DRUG APRIL Bath and Shower Cucumber Melon Scented Antibacterial HAND SANITIZER ALCOHOL LIQUID TOPICAL 20120113 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-4951_51147e3f-5558-49e0-aba3-9ae75168b149 33992-4951 HUMAN OTC DRUG APRIL Bath and Shower Sweet Pea Scented Antibacterial HAND SANITIZER ALCOHOL LIQUID TOPICAL 20120113 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-4952_a94519b2-d209-486c-b032-41aad4e6382d 33992-4952 HUMAN OTC DRUG APRIL Bath and Shower Warm Vanilla Sugar Scented Antibacterial HAND SANITIZER ALCOHOL LIQUID TOPICAL 20120114 OTC MONOGRAPH NOT FINAL part333A Greenbrier International, Inc. ALCOHOL 62 mL/100mL E 20171231 33992-5000_71923ad4-3b4d-4fca-900c-c03b5bbb31a1 33992-5000 HUMAN OTC DRUG Antibacterial Wet Wipes With Aloe BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131017 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZALKONIUM CHLORIDE .115 g/100g N 20181231 33992-5000_988c5768-e15f-472b-b6d7-f2c4160fd78a 33992-5000 HUMAN OTC DRUG Antibacterial Wet Wipes With Aloe BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110530 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZALKONIUM CHLORIDE .115 g/100g N 20181231 33992-5031_8f60cd0d-3af8-40ee-a2d7-60399b948198 33992-5031 HUMAN OTC DRUG Cold and Flu Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050804 20190226 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 33992-5111_441b7daa-69dc-42d7-8093-ee3eaf4167a6 33992-5111 HUMAN OTC DRUG ASSURED Antiseptic Wet Wipes Vitamin E and Aloe BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130819 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZALKONIUM CHLORIDE .115 g/100g E 20171231 33992-5284_e74f38d6-8564-40f4-abec-4f66169ca0ff 33992-5284 HUMAN OTC DRUG Assured Severe Congestion Nasal Relief Oxymetazoline Hydrochloride SPRAY NASAL 20150514 OTC MONOGRAPH FINAL part341 Greenbrier International, Inc OXYMETAZOLINE HYDROCHLORIDE .2 mg/.4mL N 20181231 33992-5561_3205bcf5-7142-45ca-96a4-96ffdb925418 33992-5561 HUMAN OTC DRUG Pain Relief PM Extra Relief Acetaminophen 500 mg, Diphenhydramine HCl 25 mg TABLET ORAL 20071217 20190708 OTC MONOGRAPH NOT FINAL part343 GREENBRIER INTERNATIONAL, INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 33992-6110_c2cbc647-e5d9-43c7-9f6c-b808032191c5 33992-6110 HUMAN OTC DRUG Multi Symptom Daytime Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20180118 OTC MONOGRAPH FINAL part341 Greenbrier International, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 33992-6156_1a654b9f-0feb-4b16-b5b7-e63d89746988 33992-6156 HUMAN OTC DRUG Assured Pain Relief Hot Menthol Menthol PATCH TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc MENTHOL; CAPSAICIN 30; 8.3 mg/100mg; mg/100mg N 20181231 33992-6159_b761f1a5-0918-4289-8f62-e8cb313779b7 33992-6159 HUMAN OTC DRUG Assured Cold N Hot Pain Relief Menthol Menthol PATCH TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc MENTHOL 5 mg/100mg N 20181231 33992-6775_32fe2ef6-4278-4705-9d54-7eb64ec3d23a 33992-6775 HUMAN OTC DRUG ANTIBACTERIAL BANDAGE benzalkonium chloride SWAB TOPICAL 20130816 OTC MONOGRAPH NOT FINAL part333A Greenbrier International BENZALKONIUM CHLORIDE .12 g/100g E 20171231 33992-7993_b8e4a1f5-fd56-45e9-8f7a-c0f5a6db2449 33992-7993 HUMAN OTC DRUG Assured Ice Cold Topical Analgesic CAMPHOR, MENTHOL GEL TOPICAL 20110706 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. CAMPHOR (SYNTHETIC); MENTHOL 3; 1.25 g/100g; g/100g E 20171231 33992-7994_60d86534-5a3e-4e06-ad00-f9a2aaed181c 33992-7994 HUMAN OTC DRUG ASSURED ICE COLD TOPICAL ANALGESIC MENTHOL GEL TOPICAL 20110706 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. MENTHOL 1.25 g/100g E 20171231 33992-7995_2e1b7dd0-3032-44a3-8608-dda66dbb75be 33992-7995 HUMAN OTC DRUG Assured Vaporizing Chest Rub CAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENT TOPICAL 20110706 OTC MONOGRAPH FINAL part341 Greenbrier International, Inc. CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.8; 2.6; 1.2 g/100g; g/100g; g/100g E 20171231 33992-7996_580f2345-12c0-5155-e053-2a91aa0ab013 33992-7996 HUMAN OTC DRUG Assured Vaporizing Chest Rub Camphor and Eucalyptus Oil and Menthol OINTMENT TOPICAL 20151120 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.7; 1; 1 g/100g; g/100g; g/100g N 20181231 33992-8000_616f1cc5-9d4c-25e2-e053-2a91aa0a1465 33992-8000 HUMAN OTC DRUG KLAR and DANVER ANTIBACTERIAL HAND BENZALKONIUM CHLORIDE SOAP TOPICAL 20130828 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 33992-8010_616f5740-524d-1af5-e053-2a91aa0adae6 33992-8010 HUMAN OTC DRUG KLAR and DANVER INSTANT HAND SANTIZER ETHYL ALCOHOL GEL TOPICAL 20150820 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 620 mg/mL N 20191231 33992-8376_1e70318e-6b31-438f-bb69-4c9aa8e488ed 33992-8376 HUMAN OTC DRUG ASSURED ADVANCED RELIEF EYE DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL SOLUTION OPHTHALMIC 20130228 OTC MONOGRAPH FINAL part349 GREENBRIER INTERNATIONAL, INC. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 33992-8463_dbce6c7d-a94c-48b4-9eb3-776c98f5b7e0 33992-8463 HUMAN OTC DRUG Assured Extra Strength Cold n hot Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. MENTHOL 750 mg/1 N 20181231 33992-8684_d1e4d93e-e485-4db5-a356-c2c1b102ab77 33992-8684 HUMAN OTC DRUG ASSURED NASAL RELIEF ORIGINAL OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20110308 OTC MONOGRAPH FINAL part341 GREENBRIER INTERNATIONAL, INC. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 33992-8685_e64cc0cf-0d97-4258-b16b-c1557c3f4c0e 33992-8685 HUMAN OTC DRUG Assured Nasal Relief OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20130430 OTC MONOGRAPH FINAL part341 Greenbrier International, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL N 20181231 33992-8805_4b9e5e0f-e466-4ecc-a99f-6c7a236cd334 33992-8805 HUMAN OTC DRUG SUNSHINY DAY SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8806_1a2c50ca-1c9d-4411-af7e-53c27c8c16d8 33992-8806 HUMAN OTC DRUG OUT OF THE BLUE SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8807_0e69f3c4-842f-40b5-8225-1a985c855a69 33992-8807 HUMAN OTC DRUG FRESH SPLASH SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8808_27a0786f-e404-4503-aa9f-3d2bfd41c0ca 33992-8808 HUMAN OTC DRUG SNAPPY APPLE SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8810_498d93ef-7730-4314-b214-9ff9c989ad8a 33992-8810 HUMAN OTC DRUG ANTI-BACTERIAL HAND SANITIZER 2 PACK BLUE DAY SCENTED ALCOHOL KIT 20140615 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. N 20181231 33992-8811_ad1eefdb-5104-49e9-a5e4-31de06985f36 33992-8811 HUMAN OTC DRUG ANTI-BACTERIAL HAND SANITIZER 2 PACK SPLASH APPLE SCENTED ALCOHOL KIT 20140615 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. N 20181231 33992-8815_6e6c97bc-782d-4700-8ee1-d724d32bddc4 33992-8815 HUMAN OTC DRUG ACNE FIGHTING ROLL ON GEL SALICYLIC ACID GEL TOPICAL 20140715 OTC MONOGRAPH FINAL part333D Greenbrier International, Inc. SALICYLIC ACID 2 g/100g N 20181231 33992-8816_144bd0fe-1af8-4471-bd3b-8a7fcdfcddc0 33992-8816 HUMAN OTC DRUG ANTI ITCH MENTHOL LOTION TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part348 Greenbrier International, Inc. MENTHOL .15 g/100g N 20181231 33992-8817_37bddb9a-1000-48d5-b63a-ddad4d058dce 33992-8817 HUMAN OTC DRUG CRANBERRY CHERRY SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8818_712da1a6-db96-4638-a077-9afb9a4dd39a 33992-8818 HUMAN OTC DRUG OCEAN BREEZE SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8819_ed7873e5-ed05-4976-87e4-9641c76bb180 33992-8819 HUMAN OTC DRUG APPLE BLOSSOM SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8820_88c86691-e9bd-4b88-8f32-721583ce8322 33992-8820 HUMAN OTC DRUG COCONUT WATER SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8821_9a950583-7ac3-46c1-926a-1d5f115b852d 33992-8821 HUMAN OTC DRUG CHERRY BLOSSOM SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8823_147c1b7b-0be8-4476-9f8e-dce06bdcc3a0 33992-8823 HUMAN OTC DRUG VANILLA BROWN SUGAR SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8825_5200f5ff-d6bb-4180-b06d-155a1203048b 33992-8825 HUMAN OTC DRUG ANTI-BACTERIAL HAND SANITIZER 3 PACK BLUE DAY SCENTED ALCOHOL KIT 20150106 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. E 20171231 33992-8826_7f35d132-f68e-49ff-af1a-191c7560e9e6 33992-8826 HUMAN OTC DRUG ANTI-BACTERIAL HAND SANITIZER 3 PACK 2 ALCOHOL KIT 20150106 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. E 20171231 33992-8827_0490986e-5e28-4bd4-a1b7-8b92cec21450 33992-8827 HUMAN OTC DRUG ACNE BEAUTY BENEFIT LIGHT SALICYLIC ACID CREAM TOPICAL 20150505 OTC MONOGRAPH FINAL part333D Greenbrier International, Inc. SALICYLIC ACID .5 g/100g N 20181231 33992-8828_09436dde-36e7-44b2-ae56-c06d4ec4e129 33992-8828 HUMAN OTC DRUG ACNE BEAUTY BENEFIT MEDIUM SALICYLIC ACID CREAM TOPICAL 20150505 OTC MONOGRAPH FINAL part333D Greenbrier International, Inc. SALICYLIC ACID .5 g/100g N 20181231 33992-8829_7fcc4f0f-593e-453c-aa4e-cb99b84e639e 33992-8829 HUMAN OTC DRUG DEEP CLEANSING MASK SALICYLIC ACID CREAM TOPICAL 20150505 OTC MONOGRAPH FINAL part333D Greenbrier International, Inc. SALICYLIC ACID .5 g/100g N 20181231 33992-8835_3219d971-8d47-4010-a134-7dedf6995ec8 33992-8835 HUMAN OTC DRUG VANILLA BROWN SUGAR SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20150805 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8836_7937e6f9-6d55-47cd-b329-79922456c3c2 33992-8836 HUMAN OTC DRUG CRANBERRY CHERRY SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20150805 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8837_d551a89f-b62e-4924-b54f-b1c81cb0caa8 33992-8837 HUMAN OTC DRUG JAPANESE BLOSSOM SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20150805 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8838_75c027d2-06b5-4026-a324-9858554339ae 33992-8838 HUMAN OTC DRUG ANTI-BACTERIAL 3PK BENZETHONIUM CHLORIDE KIT 20150801 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. N 20181231 33992-8850_242d7e36-4dae-198c-e054-00144ff8d46c 33992-8850 HUMAN OTC DRUG SNAPPY APPLE SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20151110 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8851_24515cab-ca43-3d4c-e054-00144ff88e88 33992-8851 HUMAN OTC DRUG FRESH SPLASH SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20151110 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8852_2454ed2a-c916-485c-e054-00144ff8d46c 33992-8852 HUMAN OTC DRUG SUNNY DAY SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20151110 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8853_2454ed2a-c940-485c-e054-00144ff8d46c 33992-8853 HUMAN OTC DRUG OUT OF THE BLUE SCENTED HAND SANITIZER ALCOHOL GEL TOPICAL 20151110 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8855_2454ed2a-c977-485c-e054-00144ff8d46c 33992-8855 HUMAN OTC DRUG ANTI-BACTERIAL HAND SANITIZER 2 PACK SPLASH APPLE SCENTED ALCOHOL KIT 20151111 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. N 20181231 33992-8856_24592450-d810-579a-e054-00144ff8d46c 33992-8856 HUMAN OTC DRUG ANTI-BACTERIAL HAND SANITIZER 2 PACK BLUE SUNSHINY SCENTED ALCOHOL KIT 20151111 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. N 20181231 33992-8857_26359dbd-032c-6d53-e054-00144ff88e88 33992-8857 HUMAN OTC DRUG VANILLA BROWN SUGAR SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8858_264b4a74-aa3c-0337-e054-00144ff8d46c 33992-8858 HUMAN OTC DRUG CRANBERRY CHERRY SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8859_264ac1b9-4da4-6295-e054-00144ff8d46c 33992-8859 HUMAN OTC DRUG JAPANESE BLOSSOM SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8860_264ac1b9-4da0-6295-e054-00144ff8d46c 33992-8860 HUMAN OTC DRUG ANTI-BACTERIAL 3PK BENZETHONIUM CHLORIDE KIT 20150801 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. N 20181231 33992-8861_2d7910a6-740b-4766-e054-00144ff8d46c 33992-8861 HUMAN OTC DRUG VANILLA BROWN SUGAR SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8862_2f18b2f3-6467-0548-e054-00144ff88e88 33992-8862 HUMAN OTC DRUG JAPANESE BLOSSOM SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20160309 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8863_2f18b2f3-647e-0548-e054-00144ff88e88 33992-8863 HUMAN OTC DRUG CRANBERRY CHERRY SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8865_2f198a6b-8fad-6d0e-e054-00144ff8d46c 33992-8865 HUMAN OTC DRUG ANTI-BACTERIAL 3PK BENZETHONIUM CHLORIDE KIT 20160301 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. N 20181231 33992-8866_2f18b2f3-6494-0548-e054-00144ff88e88 33992-8866 HUMAN OTC DRUG VANILLA BROWN SUGAR SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8867_2f18b2f3-64bf-0548-e054-00144ff88e88 33992-8867 HUMAN OTC DRUG JAPANESE BLOSSOM SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20160309 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8868_2f18b2f3-64d2-0548-e054-00144ff88e88 33992-8868 HUMAN OTC DRUG CRANBERRY CHERRY SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8869_2f198a6b-8fe7-6d0e-e054-00144ff8d46c 33992-8869 HUMAN OTC DRUG ANTI-BACTERIAL 3PK BENZETHONIUM CHLORIDE KIT TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. N 20181231 33992-8870_3aa4c4d3-c2c3-53d1-e054-00144ff88e88 33992-8870 HUMAN OTC DRUG DIMETHICONE and PETROLATUM DIMETHICONE and PETROLATUM CREAM TOPICAL 20160821 OTC MONOGRAPH FINAL part347 Greenbrier International, Inc. PETROLATUM; DIMETHICONE 30; 1 g/100g; g/100g N 20181231 33992-8871_4170245d-0129-3b69-e054-00144ff8d46c 33992-8871 HUMAN OTC DRUG VANILLA BROWN SUGAR SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20161117 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8872_41703b59-14c9-3f2c-e054-00144ff8d46c 33992-8872 HUMAN OTC DRUG JAPANESE BLOSSOM SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20161117 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8873_41703b59-1507-3f2c-e054-00144ff8d46c 33992-8873 HUMAN OTC DRUG CRANBERRY CHERRY SCENTED ANTIBAC BENZETHONIUM CHLORIDE LOTION TOPICAL 20161117 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. BENZETHONIUM CHLORIDE .12 g/100g N 20181231 33992-8875_41709710-538e-3119-e054-00144ff88e88 33992-8875 HUMAN OTC DRUG ANTI-BACTERIAL 3PK BENZETHONIUM CHLORIDE KIT TOPICAL 20161117 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. N 20181231 33992-8876_4c6db561-e781-0cb0-e054-00144ff8d46c 33992-8876 HUMAN OTC DRUG FRESH FRUIT SCENTED HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8877_4c6fc077-c8d1-397d-e054-00144ff88e88 33992-8877 HUMAN OTC DRUG OCEAN BREEZE SCENTED HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8878_4c6fc077-c8de-397d-e054-00144ff88e88 33992-8878 HUMAN OTC DRUG JAPANESE BLOSSOM SCENTED HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8879_4c70409e-ef0c-0c99-e054-00144ff8d46c 33992-8879 HUMAN OTC DRUG HAND SANITIZER 3PK ETHYL ALCOHOL KIT 20170405 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. N 20181231 33992-8880_516b8c3e-2b97-6669-e054-00144ff88e88 33992-8880 HUMAN OTC DRUG VERY VANILLA SCENTED HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20170608 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8881_516c8c9b-9246-0dc5-e054-00144ff88e88 33992-8881 HUMAN OTC DRUG OCEAN BREEZE SCENTED HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20170608 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8882_516cbbb2-76cf-5638-e054-00144ff8d46c 33992-8882 HUMAN OTC DRUG SWEEN CLEMENTINE SCENTED HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20170608 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8883_516cbbb2-76e3-5638-e054-00144ff8d46c 33992-8883 HUMAN OTC DRUG FRUIT FLORAL SCENTED HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20170608 OTC MONOGRAPH NOT FINAL part333E Greenbrier International, Inc. ALCOHOL 62 mL/100mL N 20181231 33992-8885_5f341326-7b20-ccad-e053-2991aa0a64be 33992-8885 HUMAN OTC DRUG SALICYLIC ACID SALICYLIC ACID LIQUID TOPICAL 20171101 OTC MONOGRAPH FINAL part333D Greenbrier International, Inc. SALICYLIC ACID 2 g/100g N 20181231 33992-8900_5f434e4b-4bac-1686-e053-2991aa0ac526 33992-8900 HUMAN OTC DRUG SALICYLIC ACID SALICYLIC ACID GEL TOPICAL 20171115 OTC MONOGRAPH FINAL part333D Greenbrier International, Inc. SALICYLIC ACID 2 g/100g N 20181231 33992-9376_051c56f5-0fc6-4dfb-9750-2c21d6a249e4 33992-9376 HUMAN OTC DRUG ASSURED ORIGINAL RELIEF EYE TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20130228 OTC MONOGRAPH FINAL part349 GREENBRIER INTERNATIONAL, INC. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 34022-101_1a7f1497-83da-445e-9cca-59e979b986e3 34022-101 HUMAN OTC DRUG DAY CREAM MATTIFYING HYDRATOR SPF 25 OCTINOXATE AVOBENZONE LOTION TOPICAL 20120121 OTC MONOGRAPH FINAL part352 MOSAIC MARKETING PARTNERS LLC OCTINOXATE; AVOBENZONE 6.6; 1.7 g/100mL; g/100mL N 20181231 34022-102_dd8f4566-e8ae-4cd5-ae41-60017d644faf 34022-102 HUMAN OTC DRUG DAY CREAM REPLENISHING HYDRATOR SPF 25 OCTINOXATE AVOBENZONE LOTION TOPICAL 20120121 OTC MONOGRAPH FINAL part352 MOSAIC MARKETING PARTNERS LLC OCTINOXATE; AVOBENZONE 6.6; 1.7 g/100mL; g/100mL N 20181231 34057-001_b32c22fb-4770-4d3a-acd9-b984046326b6 34057-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19770101 NDA NDA205849 Oxarc, Inc. OXYGEN 990 mL/L N 20181231 34057-006_205f4e34-91a2-48dd-afd0-6bba1405d093 34057-006 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19770101 NDA NDA205847 Oxarc, Inc. AIR 1000 mL/L N 20181231 34057-010_60bfefe2-66a2-3c82-e053-2a91aa0a1c4e 34057-010 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19770101 NDA NDA206009 Oxarc, Inc. NITROUS OXIDE 990 mL/L N 20181231 34057-014_9913b56e-3507-4710-9c07-ac38aedec2e4 34057-014 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19770101 NDA NDA205850 Oxarc, Inc. NITROGEN 990 mL/L N 20181231 34057-501_d42cbdd2-060d-4b6c-99b2-d28546f1b7c9 34057-501 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20150709 NDA NDA205852 Oxarc, Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 34330-001_482828d4-0ec3-4010-bb1b-93bc292983c0 34330-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Compressed Gases Inc OXYGEN 99 L/100L E 20171231 34330-002_44f86ed5-d087-4a14-bf12-f2d07acf75cb 34330-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS Compressed Gases Inc NITROGEN 99 L/100L E 20171231 34330-003_c4b4e135-e6dc-4ee0-b7e8-03c081ca8ebb 34330-003 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS Compressed Gases Inc NITROUS OXIDE 99 L/100L E 20171231 34331-202_c0a67c7f-df00-481e-b968-1818d99e1b23 34331-202 HUMAN OTC DRUG LipiGesic M Feverfew and Ginger GEL SUBLINGUAL 20110808 UNAPPROVED HOMEOPATHIC PuraMed BioScience, Inc. FEVERFEW; GINGER 3; 2 [hp_X]/mL; [hp_X]/mL E 20171231 34331-302_1bc7d248-b502-452c-87bd-8a23edb4eb8c 34331-302 HUMAN OTC DRUG MigraPure Feverfew and Ginger GEL SUBLINGUAL 20150101 UNAPPROVED HOMEOPATHIC PuraMed BioScience, Inc. FEVERFEW; GINGER 3; 2 [hp_X]/mL; [hp_X]/mL E 20171231 34362-0230_8594a892-1147-4af7-b175-a5534ef2a1ac 34362-0230 HUMAN OTC DRUG The Natural Dentist Sensitivity Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH NOT FINAL part356 Caldwell Consumer Health LLC SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 34362-0231_d4e96c23-9636-4f32-9f5f-799fecd59b63 34362-0231 HUMAN OTC DRUG The Natural Dentist Berry Blast Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH FINAL part355 Caldwell Consumer Health LLC SODIUM FLUORIDE .243 g/100g N 20181231 34362-0232_051f0a92-c9f7-4c8f-9661-05927f0500e4 34362-0232 HUMAN OTC DRUG The Natural Dentist Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH FINAL part355 Caldwell Consumer Health LLC SODIUM FLUORIDE .243 g/100g N 20181231 34362-0233_830919e6-9e5a-4d54-bd01-0efd8af13445 34362-0233 HUMAN OTC DRUG The Natural Dentist Groovy Grape Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH FINAL part355 Caldwell Consumer Health LLC SODIUM FLUORIDE .243 g/100g N 20181231 34362-0234_97b1099c-5ccd-4f36-b44b-f707db5cc318 34362-0234 HUMAN OTC DRUG The Natural Dentist Peppermint Twist Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH FINAL part355 Caldwell Consumer Health LLC SODIUM FLUORIDE .243 g/100g N 20181231 34362-0235_e133eb25-0f73-4be3-b61a-a05f3e9526b6 34362-0235 HUMAN OTC DRUG The Natural Dentist Orange Zest Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH FINAL part355 Caldwell Consumer Health LLC SODIUM FLUORIDE .243 g/100g N 20181231 34362-0236_46ee0bb5-5157-4b3c-be45-9d21fdc02919 34362-0236 HUMAN OTC DRUG The Natural Dentist Peppermint Sage Peppermint PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH NOT FINAL part356 Caldwell Consumer Health LLC PEPPERMINT OIL; SAGE OIL .1; .02 g/100g; g/100g N 20181231 34362-0270_8764e374-b93f-4ec0-8177-7e880449b2ec 34362-0270 HUMAN OTC DRUG The Natural Dentist Peppermint Twist Fluoride PASTE, DENTIFRICE DENTAL 20110501 OTC MONOGRAPH FINAL part355 Caldwell Consumer Health LLC SODIUM FLUORIDE .243 g/100g N 20181231 34362-0300_9a4c2790-9192-4949-8529-c1b19a8a3f66 34362-0300 HUMAN OTC DRUG Conceptrol Options Nonoxynol GEL VAGINAL 20110501 OTC MONOGRAPH NOT FINAL part333A Caldwell Consumer Health LLC NONOXYNOL-9 4 g/100g N 20181231 34362-0302_7a842e7f-9413-47c6-a062-bf9b6ce7cf2f 34362-0302 HUMAN OTC DRUG Gynol II Extra Strength Nonoxynol GEL VAGINAL 20110501 OTC MONOGRAPH NOT FINAL part333A Caldwell Consumer Health LLC NONOXYNOL-9 3 g/100g N 20181231 34362-0510_88d0c3b9-fba8-4810-b02c-69c84116bfd1 34362-0510 HUMAN OTC DRUG The Natural Dentist Rinse Hydrogen Peroxide RINSE DENTAL 20151201 OTC MONOGRAPH NOT FINAL part356 Caldwell Consumer Health LLC HYDROGEN PEROXIDE .15 mL/100mL N 20181231 34460-6001_f69b1715-0d7b-41c7-892a-53e5062f3f2f 34460-6001 HUMAN OTC DRUG Red Apple Antibacterial Hand Triclosan SOAP TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333A Zhejiang Blue Dream Cosmetics Co., Ltd. TRICLOSAN .115 g/100g E 20171231 34460-6002_f73a368a-32fe-40dd-aa8e-0eeca4ec630f 34460-6002 HUMAN OTC DRUG Pear Barlet Antibacterial Hand Triclosan SOAP TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Zhejiang Blue Dream Cosmetics Co., Ltd. TRICLOSAN .115 g/100g E 20171231 34460-6003_80b844e6-de58-4283-ac67-0b9404fb9299 34460-6003 HUMAN OTC DRUG Lemon Zest Antibacterial Hand Triclosan SOAP TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Zhejiang Blue Dream Cosmetics Co., Ltd. TRICLOSAN .115 g/100g E 20171231 34460-6004_23ffa693-24ca-441d-8d95-385fcd469c9b 34460-6004 HUMAN OTC DRUG Mandarin Orange Antibacterial Hand Triclosan SOAP TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Zhejiang Blue Dream Cosmetics Co., Ltd. TRICLOSAN .115 g/100g E 20171231 34460-6005_42df1a89-9240-4c14-aac1-27ee77306eaa 34460-6005 HUMAN OTC DRUG Frosted Berries and Cream Sanitizer Pen ALCOHOL LIQUID TOPICAL 20100807 OTC MONOGRAPH NOT FINAL part333 Zhejiang Blue Dream Cosmetics Co., Ltd. ALCOHOL 62 g/100g E 20171231 34460-6006_a725fba6-9f92-43a5-911b-299f35619180 34460-6006 HUMAN OTC DRUG Sweet Candy Kiss Sanitizer Pen ALCOHOL LIQUID TOPICAL 20100807 OTC MONOGRAPH NOT FINAL part333 Zhejiang Blue Dream Cosmetics Co., Ltd. ALCOHOL 62 g/100g E 20171231 34460-6007_2079c0da-cb7f-4a02-8d19-c49a3b85cba5 34460-6007 HUMAN OTC DRUG Icee Blue Raspberry Scented Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100807 OTC MONOGRAPH NOT FINAL part333E Zhejiang Blue Dream Cosmetics Co., Ltd. ALCOHOL 62 g/100g E 20171231 34460-6008_6650b768-c7b7-407b-bda7-410832b25f34 34460-6008 HUMAN OTC DRUG Icee Strawberry Scented Hand Sanitizer ALCOHOL LIQUID TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Zhejiang Blue Dream Cosmetics Co., Ltd. ALCOHOL 62 g/100g E 20171231 34460-6009_8dfdad81-4f0d-4187-af6e-0c48d2d76403 34460-6009 HUMAN OTC DRUG Icee White Cherry Scented Hand Sanitizer ALCOHOL LIQUID TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Zhejiang Blue Dream Cosmetics Co., Ltd. ALCOHOL 62 g/100g E 20171231 34605-5001_22ca8f44-40ee-42e9-83e1-72eca1006e9b 34605-5001 HUMAN OTC DRUG NOSMO KING smoking deterrent clove TABLET, SOLUBLE ORAL 20100317 UNAPPROVED DRUG OTHER Nosmo Co., Ltd CLOVE; LEMON; MENTHOL .11875; .001; .0015 g/1; g/1; g/1 E 20171231 34605-6001_f0f96e67-c784-4eef-805a-631bd0097124 34605-6001 HUMAN OTC DRUG Nosmotea smoking deterrent clove tea POWDER ORAL 20100306 UNAPPROVED DRUG OTHER Nosmo Co., Ltd CLOVE; LEMON; MENTHOL 20; 1; 1.5 mg/g; mg/g; mg/g E 20171231 34645-1028_069eca22-4484-478d-b6d8-dcc907401dad 34645-1028 HUMAN OTC DRUG Povidone Iodine Impregnated Povidone Iodine SPONGE TOPICAL 20150910 OTC MONOGRAPH NOT FINAL part333E Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 7.5 mg/mL N 20181231 34645-1029_28221e4d-09e0-4d21-8f66-ff31fe4e6346 34645-1029 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SWAB TOPICAL 20150910 OTC MONOGRAPH NOT FINAL part333E Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mg/mL N 20181231 34645-1030_280a8ca0-9c48-45e3-9ac4-fbedc442ebb7 34645-1030 HUMAN OTC DRUG Povidone Iodine Impregnated Povidone Iodine SPONGE TOPICAL 20150303 OTC MONOGRAPH NOT FINAL part333E Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mg/mL N 20181231 34645-1031_6bcbdefa-22d7-4313-a797-703968c8b47a 34645-1031 HUMAN OTC DRUG Povidone Iodine Impregnated Povidone Iodine SPONGE TOPICAL 20150303 OTC MONOGRAPH NOT FINAL part333E Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 7.5 mg/mL N 20181231 34645-1032_a7ab50b3-9936-42b0-bc74-1a0b4af24662 34645-1032 HUMAN OTC DRUG Povidone Iodine Impregnated Povidone Iodine SPONGE TOPICAL 20150303 OTC MONOGRAPH NOT FINAL part333E Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 7.5 mg/mL N 20181231 34645-1040_cbdb4167-a2a4-4d12-b97a-3336b73fdb0b 34645-1040 HUMAN OTC DRUG Povidone Iodine Topical Solution Paint Povidone Iodine 10% LIQUID TOPICAL 20150331 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province Jianerkang Medical Dressing Co., Ltd. POVIDONE-IODINE 100 mg/mL N 20181231 34645-1041_f2cb57cd-9ddd-4ff0-a09d-1c48590f309b 34645-1041 HUMAN OTC DRUG Povidone Iodine Topical Solution Paint Povidone Iodine 10% LIQUID TOPICAL 20150331 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province Jianerkang Medical Dressing Co., Ltd. POVIDONE-IODINE 100 mg/mL N 20181231 34645-1042_c9d65db4-4c22-4f0f-a96f-eec5e436a80f 34645-1042 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20150611 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province Jianerkang Medical Dressing Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 34645-1043_a9c198e8-e347-4d51-81ac-023462ebe351 34645-1043 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SWAB TOPICAL 20150611 OTC MONOGRAPH NOT FINAL part333E Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mg/mL N 20181231 34645-1044_f57f5b0c-856f-493f-b5b5-a38b097db00b 34645-1044 HUMAN OTC DRUG Povidone Iodine Scrub Povidone Iodine SWAB TOPICAL 20150611 OTC MONOGRAPH NOT FINAL part333E Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .75 mg/mL N 20181231 34645-2105_6194327e-b075-bf1e-e053-2a91aa0afc54 34645-2105 HUMAN OTC DRUG Lemon Glycerin Glycerin SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part347 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. GLYCERIN 500 mg/mL N 20191231 34645-2308_6191aa37-9171-207c-e053-2a91aa0af2d0 34645-2308 HUMAN OTC DRUG Acetone Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 34645-2325_6191aa37-918d-207c-e053-2a91aa0af2d0 34645-2325 HUMAN OTC DRUG Acetone Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 34645-2608_61945ac9-8a37-e693-e053-2991aa0ae82d 34645-2608 HUMAN OTC DRUG Personal Cloth Wipes Witch Hazel SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part346 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. WITCH HAZEL 500 mg/mL N 20191231 34645-2712_6194e06f-63e9-1ef0-e053-2991aa0a8f1e 34645-2712 HUMAN OTC DRUG PCMX Surgical Scrub Chloroxylenol SPONGE TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. CHLOROXYLENOL 40 mg/mL N 20191231 34645-2720_61947d16-8793-3c1b-e053-2a91aa0a190b 34645-2720 HUMAN OTC DRUG PCMX Surgical Scrub Chloroxylenol SPONGE TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. CHLOROXYLENOL 33 mg/mL N 20191231 34645-3008_61922619-f6ce-31ac-e053-2a91aa0a09c3 34645-3008 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 34645-3018_61922977-4be0-680b-e053-2a91aa0afcc7 34645-3018 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 34645-3025_61922977-4bfa-680b-e053-2a91aa0afcc7 34645-3025 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 34645-3026_6182580e-3c6c-1eae-e053-2a91aa0af7f4 34645-3026 HUMAN OTC DRUG Isopropyl Alcohol Surgical Scrub Isopropyl Alcohol SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part344 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .07 mL/mL N 20181231 34645-3030_a6ce0cc2-d633-433a-8f71-541d2c070d11 34645-3030 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 34645-3031_6283ee95-1a7c-498a-aae2-7d54e08e3777 34645-3031 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 34645-3110_61924332-9dc5-5d51-e053-2991aa0aba8c 34645-3110 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 34645-3111_61924332-9de2-5d51-e053-2991aa0aba8c 34645-3111 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 34645-4000_5a2f0be9-4622-48a3-be3c-30afaffb3845 34645-4000 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SWAB TOPICAL 20080101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL N 20181231 34645-4001_ef2df7a9-fb9c-481c-b29a-76908060ad60 34645-4001 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SWAB TOPICAL 20080101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL N 20181231 34645-4002_654d88ea-2d79-4e90-8721-b255690c48e5 34645-4002 HUMAN OTC DRUG Povidone-Iodine Prep Pad Povidone-Iodine SWAB TOPICAL 20080101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .1 mL/mL N 20181231 34645-4008_61909779-9871-b41d-e053-2a91aa0a4b74 34645-4008 HUMAN OTC DRUG Povidone Iodine Prep Pad Povidone-Iodine SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333C Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 10 mg/100mL N 20191231 34645-4009_61912762-9f43-506e-e053-2a91aa0af33f 34645-4009 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333C Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 7.5 mg/mL N 20191231 34645-4010_6190cbf0-2169-f1a0-e053-2991aa0ad792 34645-4010 HUMAN OTC DRUG Povidone Iodine Impregnated Povidone Iodine SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333C Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 10 mg/mL N 20191231 34645-4012_6193eaae-a87e-3898-e053-2991aa0a2616 34645-4012 HUMAN OTC DRUG Povidone Iodine Surgical Scrub Povidone Iodine SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333C Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 90 mg/mL N 20191231 34645-4019_6194ae55-404f-4f0c-e053-2991aa0a6805 34645-4019 HUMAN OTC DRUG Povidone Iodine Povidone-Iodine SWAB TOPICAL 20100301 OTC MONOGRAPH FINAL part333C Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 100 mg/mL N 20191231 34645-4020_6190939b-c482-b010-e053-2991aa0a4788 34645-4020 HUMAN OTC DRUG Povidone Iodine Impregnated Povidone Iodine SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333C Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 7.5 mg/mL N 20191231 34645-4021_6194325e-c2a7-9250-e053-2991aa0a7149 34645-4021 HUMAN OTC DRUG Povidone Iodine Surgical Scrub Povidone Iodine SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333C Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 100 mg/mL N 20191231 34645-4025_eac5235a-f2ee-468e-af45-116ee28219b3 34645-4025 HUMAN OTC DRUG Povidone Iodine Scrub Povidone-Iodine SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE .075 mL/mL N 20181231 34645-4050_618f4961-7f2c-7e8f-e053-2991aa0a12a9 34645-4050 HUMAN OTC DRUG Povidone Iodine Scrub Povidone-Iodine SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333C Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 10 mg/mL N 20191231 34645-4059_61919df7-c08b-0cb9-e053-2a91aa0a5e1d 34645-4059 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333C Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 10 mg/mL N 20191231 34645-4109_61913cca-8ff0-2f7c-e053-2991aa0ab824 34645-4109 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333C Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 10 mg/mL N 20191231 34645-4112_6193eaae-a87d-3898-e053-2991aa0a2616 34645-4112 HUMAN OTC DRUG Povidone Iodine Surgical Scrub Povidone Iodine SPONGE TOPICAL 20100101 OTC MONOGRAPH FINAL part333C Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 50 mg/mL N 20191231 34645-4188_61918b73-75e4-e953-e053-2a91aa0aaa83 34645-4188 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333C Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. POVIDONE-IODINE 10 mg/mL N 20191231 34645-4190_617f0584-3d58-913c-e053-2a91aa0a5a52 34645-4190 HUMAN OTC DRUG Sting Relief BENZOCAINE, ISOPROPYL ALCOHOL SWAB TOPICAL 20161003 OTC MONOGRAPH NOT FINAL part333A JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO., LTD. BENZOCAINE; ISOPROPYL ALCOHOL 6; 60 g/100g; g/100g N 20181231 34645-4242_4d58527e-8d95-4331-b9a0-3d1dd7357e7a 34645-4242 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 34645-5000_e9fead15-cc40-4d58-98f2-6b21ac68965b 34645-5000 HUMAN OTC DRUG First Aid Antiseptic Benzalkonium Chloride SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co.,Ltd BENZALKONIUM CHLORIDE .0013 mL/mL N 20181231 34645-5001_62705c80-c4b5-42c1-af1b-fba169692bcc 34645-5001 HUMAN OTC DRUG Wash Benzalkonium Chloride SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co.,Ltd BENZALKONIUM CHLORIDE .0013 mL/mL N 20181231 34645-5002_60609692-3bf4-4c40-b5bd-00522b7ae659 34645-5002 HUMAN OTC DRUG Obstetrical Antiseptic Benzalkonium Chloride SWAB TOPICAL 20060101 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co.,Ltd BENZALKONIUM CHLORIDE .0013 mL/mL N 20181231 34645-5008_61928e56-555b-cad1-e053-2991aa0af76b 34645-5008 HUMAN OTC DRUG BZK Benzalkonium Chloride SWAB TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province JianErKang Medical Dressing Co.,Ltd BENZALKONIUM CHLORIDE 1.33 mg/mL N 20191231 34645-5018_61926516-9957-cbda-e053-2a91aa0aa6f3 34645-5018 HUMAN OTC DRUG First Aid Antiseptic Benzalkonium Chloride SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. BENZALKONIUM CHLORIDE .13 mg/100mL N 20191231 34645-5028_61928b8a-8c3a-bafd-e053-2a91aa0adcbe 34645-5028 HUMAN OTC DRUG Wash Towelette Benzalkonium Chloride SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 34645-5038_61956c46-fd96-ce9d-e053-2991aa0af1fb 34645-5038 HUMAN OTC DRUG OB Cleansing Towelette Benzalkonium Chloride SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 34645-5048_61928e56-555c-cad1-e053-2991aa0af76b 34645-5048 HUMAN OTC DRUG Wash-Up Towelette Benzalkonium Chloride SWAB TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 34645-5500_47a504b8-b0c1-030a-e054-00144ff88e88 34645-5500 HUMAN OTC DRUG Povidone Iodine Prep Pad POVIDONE-IODINE SOLUTION TOPICAL 20170130 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province Jianerkang Medical Dressing Co., Ltd POVIDONE-IODINE 10 g/100g N 20181231 34645-5501_47a504b8-b0b0-030a-e054-00144ff88e88 34645-5501 HUMAN OTC DRUG Providone Iodine Prep POVIDONE-IODINE SOLUTION TOPICAL 20170130 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province Jianerkang Medical Dressing Co., Ltd POVIDONE-IODINE 7.5 g/100g N 20181231 34645-5502_47a5690c-08ae-5092-e054-00144ff8d46c 34645-5502 HUMAN OTC DRUG Providone Iodine Prep POVIDONE-IODINE SOLUTION TOPICAL 20170130 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province Jianerkang Medical Dressing Co., Ltd POVIDONE-IODINE 7.5 g/100g N 20181231 34645-5503_47a5726f-d303-50d9-e054-00144ff8d46c 34645-5503 HUMAN OTC DRUG Providone Iodine Prep POVIDONE-IODINE SOLUTION TOPICAL 20170130 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province Jianerkang Medical Dressing Co., Ltd POVIDONE-IODINE 10 g/100g N 20181231 34645-5504_47a5726f-d315-50d9-e054-00144ff8d46c 34645-5504 HUMAN OTC DRUG Providone Iodine Prep POVIDONE-IODINE SOLUTION TOPICAL 20170130 OTC MONOGRAPH NOT FINAL part333A Jiangsu Province Jianerkang Medical Dressing Co., Ltd POVIDONE-IODINE 10 g/100g N 20181231 34645-7008_6192f09a-78d8-7ddb-e053-2991aa0ae820 34645-7008 HUMAN OTC DRUG Sting Relief Pads Benzocaine SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part346 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. BENZOCAINE 60 mg/mL N 20191231 34645-8030_ffab3590-e3b1-44fb-86fe-73c9221d7635 34645-8030 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20100501 OTC MONOGRAPH FINAL part333 Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. HYDROGEN PEROXIDE .03 mL/mL N 20181231 34666-001_46f6d22c-dded-41d1-b4dc-0a209dc167f1 34666-001 HUMAN OTC DRUG Arnica Montana Nartex Arnica montana, Hamamelis Virginiana CREAM TOPICAL 20070601 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ARNICA MONTANA; HAMAMELIS VIRGINIANA LEAF 1.73; .0178 g/29.7g; g/29.7g N 20181231 34666-002_fe69700a-4100-48ee-86d4-841d0ef013b9 34666-002 HUMAN OTC DRUG APETYL Syrup Avena sativa 3X, China officinalis 3X and Hydrastis canadensis 3X SYRUP ORAL 20090730 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV AVENA SATIVA POLLEN; CINCHONA OFFICINALIS BARK; HYDRASTIS CANADENSIS EXTRACT 3; 3; 3 [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL N 20181231 34666-003_c7d00441-3353-4349-b448-2e0f19eb345a 34666-003 HUMAN OTC DRUG Calmex Ignatia Amara, Kali Phosphoricum, Passiflora Incarnata, Valeriana Officinalis TABLET ORAL 20090801 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-004_92e71a9f-50e0-43e2-b3b0-01ddfaf0ccbd 34666-004 HUMAN OTC DRUG LIBERATE Nux Vomica TABLET ORAL 20090801 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV STRYCHNOS NUX-VOMICA SEED 50 [hp_X]/1 N 20181231 34666-005_bcf9e290-05f6-4812-8c7a-83a1782e9d88 34666-005 HUMAN OTC DRUG CALM-ITO Coffea Cruda, Cypripendium, Hyoscyamus and Matricaria Chamomilla TABLET ORAL 20090801 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopaticos, S.A. de C.V. COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; MATRICARIA RECUTITA; HYOSCYAMUS NIGER 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-006_a7d7944f-2acd-4574-952d-6beec839e70c 34666-006 HUMAN OTC DRUG Revitalix China officinalis, Ferrum Phosphoricum and Medicago Sativa SYRUP ORAL 20090801 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV CINCHONA OFFICINALIS BARK; ALFALFA LEAF 8; 8 [hp_X]/240mL; [hp_X]/240mL N 20181231 34666-007_5be61ec6-280d-457a-8145-28310854d37a 34666-007 HUMAN OTC DRUG Arnica Montana Nartex Arnica Montana, Hamamelis virginica OINTMENT TOPICAL 20101223 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ARNICA MONTANA; HAMAMELIS VIRGINIANA LEAF 1.66; 1.66 g/28g; g/28g N 20181231 34666-008_d9eb20ba-b92e-4bad-b846-b882ee59042c 34666-008 HUMAN OTC DRUG Simplex Passiflora incarnata, Ignatia Amara, Valeriana Officinalis TABLET ORAL 20101223 UNAPPROVED HOMEOPATHIC Nartex Laboratories PASSIFLORA INCARNATA FLOWER; STRYCHNOS IGNATII SEED; VALERIAN 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-009_0291dd0a-9245-4915-a837-95993343217e 34666-009 HUMAN OTC DRUG Revitalix Medicago Sativa L., Cinchona Officinalis L., Ferrosoferric Phosphate SYRUP ORAL 20140516 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopati cos, S.A. de C.V. FERROSOFERRIC PHOSPHATE; AVENA SATIVA POLLEN; CINCHONA OFFICINALIS WHOLE 8; 8; 8 [hp_X]/240g; [hp_X]/240g; [hp_X]/240g N 20181231 34666-010_aa925dbb-25a2-4d22-9839-365f7b0ea1a0 34666-010 HUMAN OTC DRUG Arnica Recovery Arnica Montana TABLET ORAL 20110701 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ARNICA MONTANA 6 [hp_C]/1 N 20181231 34666-011_d12b0e37-568f-4dfb-904e-6432efe8bac1 34666-011 HUMAN OTC DRUG Lari-Clear Baryta carbonica, Belladonna atropa, Phytolacca decandra PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BARIUM CARBONATE; BELLADONNA LEAF; PHYTOLACCA AMERICANA ROOT 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-012_9e7890d2-0bd1-4dcf-9a14-efd83434e896 34666-012 HUMAN OTC DRUG APETYL Syrup Avena sativa 3X, China officinalis 3X and Hydrastis canadensis 3X SYRUP ORAL 20090730 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopati cos, S.A. de C.V. AVENA SATIVA POLLEN; CINCHONA OFFICINALIS WHOLE; HYDRASTIS CANADENSIS WHOLE 3; 3; 3 [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL N 20181231 34666-021_c504f50f-7331-487b-b284-4d2abdaf988c 34666-021 HUMAN OTC DRUG Appetyl Kids Cinchona pubescens, Hydrastis canadensis, Nux vomica PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV CINCHONA PUBESCENS BARK; GOLDENSEAL; STRYCHNOS NUX-VOMICA SEED 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-031_338ea921-98bf-43ee-8db7-9b0458972e0b 34666-031 HUMAN OTC DRUG K-Loss Fucus vesiculosus, Graphites, Phytolacca decandra PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV FUCUS VESICULOSUS; GRAPHITE; PHYTOLACCA AMERICANA ROOT 4; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-040_7a17e703-09b6-4597-be26-b9c3f6cc2097 34666-040 HUMAN OTC DRUG K-Loss Fucus vesiculosus, Graphites, Phytolacca decandra TABLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV FUCUS VESICULOSUS; GRAPHITE; PHYTOLACCA AMERICANA ROOT 4; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-050_2446aec6-f93a-4ca2-8e11-883c8c791d6c 34666-050 HUMAN OTC DRUG Menop-aid Cimicifuga, Lachesis trigonocephalus, Lilium tigrinum TABLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BLACK COHOSH; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM BULB 6; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-060_8d7bd364-48c0-417a-acb9-3a65cbb95125 34666-060 HUMAN OTC DRUG Dismen-aid pms Chamomilla matricaria, Viburnum prunifolium, Viburnum opulus, Dioscorea Villosa TABLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV CHAMOMILE; VIBURNUM PRUNIFOLIUM BARK; VIBURNUM OPULUS BARK; DIOSCOREA VILLOSA ROOT 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-061_3a7bf06a-27bf-4f95-a909-b1756f097e22 34666-061 HUMAN OTC DRUG Menop-aid Cimicifuga, Lachesis trigonocephalus, Lilium tigrinum PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BLACK COHOSH; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM BULB 6; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-071_600f9ce2-3a81-4147-afda-b5ba96add809 34666-071 HUMAN OTC DRUG Migraid Cyclamen europaeum, Gelsemium sempervirens, Iris versivolor, Spigelia anthelmia PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV CYCLAMEN PURPURASCENS TUBER; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; SPIGELIA ANTHELMIA 4; 4; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-081_8f696ba1-5f5f-4a80-8f28-261503e58441 34666-081 HUMAN OTC DRUG Gastrolean Magnesia carbonica, Natrum sulphuricum, Nux vomica, Robinia pseudoacacia PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV MAGNESIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; ROBINIA PSEUDOACACIA BARK 8; 8; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-091_9bdd9e5a-dc99-42d0-8d92-d1e6ae9e57f5 34666-091 HUMAN OTC DRUG Arnica Montana Arnica Montana PELLET ORAL 20110701 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ARNICA MONTANA 6 [hp_C]/1 N 20181231 34666-101_19bd8876-325b-4f99-b03d-241d5b6ddbe1 34666-101 HUMAN OTC DRUG Flu-less Aconitum napellus, Dulcamara, Gelsemium sempervirens PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ACONITUM NAPELLUS; SOLANUM DULCAMARA FLOWER; GELSEMIUM SEMPERVIRENS ROOT 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-111_2407e193-1d07-4146-a68e-d15ec83fef80 34666-111 HUMAN OTC DRUG Allerghin Dolichos pruriens, Rhus toxicodendron, Urtica urens PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV MUCUNA PRURIENS FRUIT TRICHOME; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-121_f844c322-0e2c-4918-8753-357e6eaee1a8 34666-121 HUMAN OTC DRUG Nartussal Bryonia alba, Drosera rotundifolia, Ipecacuanha PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-131_f25eae96-7742-4df8-9fac-cb9902cc5539 34666-131 HUMAN OTC DRUG Simplex Jr Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Matricaria chamomilla PELLET ORAL 20110725 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HYOSCYAMUS NIGER; MATRICARIA CHAMOMILLA FLOWERING TOP OIL 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-141_88c703ce-53a8-4fed-9ac7-e680fa96898e 34666-141 HUMAN OTC DRUG Flu-less Aconitum napellus, Dulcamara, Gelsemium sempervirens TABLET ORAL 20120910 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ACONITUM NAPELLUS; SOLANUM DULCAMARA FLOWER; GELSEMIUM SEMPERVIRENS ROOT 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-151_afad6e98-5a10-4bdf-8033-71a959cce84d 34666-151 HUMAN OTC DRUG Nartussal Bryonia alba, Drosera rotundifolia, Ipecacuanha TABLET ORAL 20120910 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-161_ed3e6f1c-a01f-4dc0-bf27-5ebe7a6c32d1 34666-161 HUMAN OTC DRUG Lari-Clear Baryta carbonica, Belladonna atropa, Phytolacca decandra TABLET ORAL 20120910 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BARIUM CARBONATE; BELLADONNA LEAF; PHYTOLACCA AMERICANA ROOT 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 34666-171_40f02f48-a567-4d01-a5d1-f39976083b55 34666-171 HUMAN OTC DRUG Nartussal Bryonia alba, Drosera rotundifolia, Ipecacuanha SYRUP ORAL 20120910 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC 5; 5; 5 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL N 20181231 34666-181_cf0b7cce-0e1d-4a7e-9ef2-02f7a21f3e7c 34666-181 HUMAN OTC DRUG Calendulax Calendula officinalis OINTMENT TOPICAL 20150417 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopaticos SA DE CV CALENDULA OFFICINALIS FLOWERING TOP 2.973 g/28.35g N 20181231 34666-191_f879e9e2-04c6-4088-afd0-c1eaccb6c5de 34666-191 HUMAN OTC DRUG Hemorrhoidex Aesculus hipp, Collinsonia, Hamamelis TABLET ORAL 20150301 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopaticos SA DE CV HORSE CHESTNUT; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 34666-201_b71598a2-2a80-44e5-acf4-9780e3a69f26 34666-201 HUMAN OTC DRUG Hemorrhoidex Ratanhia, Hamamelis OINTMENT TOPICAL 20150417 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopaticos SA DE CV KRAMERIA LAPPACEA ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 3; 1 [hp_X]/28.35g; [hp_X]/28.35g N 20181231 34666-211_17c70f90-1e27-45cf-bb72-b23cc3d8b3f0 34666-211 HUMAN OTC DRUG Varix Hamamelis, Pulsatilla TABLET ORAL 20150301 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PULSATILLA VULGARIS 3; 6 [hp_X]/1; [hp_X]/1 N 20181231 34666-221_64417046-adb0-4df5-8bb1-e1098395a24f 34666-221 HUMAN OTC DRUG Varix Hamamelis, Pulsatilla OINTMENT TOPICAL 20150417 UNAPPROVED HOMEOPATHIC Nartex Laboratorios Homeopaticos SA DE CV HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PULSATILLA VULGARIS 1.486; 6 g/28.35g; [hp_X]/28.35g N 20181231 34666-231_6ea58c4f-0eb7-4841-bf57-46908d5a3d9c 34666-231 HUMAN OTC DRUG Muelsin calcarea carbonica, chamomilla, coffea cruda LIQUID ORAL 20160511 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; ARABICA COFFEE BEAN 3; 3; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 34666-241_58b226c6-73ce-48a5-bae6-10c01daf97a1 34666-241 HUMAN OTC DRUG alibeli Chamomilla, Colocynthis, Magnesia phosphorica LIQUID ORAL 20160511 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 5; 6; 6; 6 [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL N 20181231 34666-251_4ce8195c-67a2-4b66-9728-9a656b48a4ce 34666-251 HUMAN OTC DRUG St. Johns Wort Hypericum TABLET ORAL 20170515 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ST. JOHN'S WORT .176 g/1 N 20181231 34666-261_714b10f8-4dc7-4f78-ab94-2529a48be13e 34666-261 HUMAN OTC DRUG Buccaliv Arsenicum album, Mezereum, Natrum muriaticum, Rhus toxicodendron CREAM TOPICAL 20170515 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ARSENIC TRIOXIDE; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; TOXICODENDRON RADICANS LEAF 8; 6; 12; 8 [hp_X]/15g; [hp_X]/15g; [hp_X]/15g; [hp_X]/15g N 20181231 34666-271_ddd16a79-cb7b-4ea6-ac6c-daba4db38d12 34666-271 HUMAN OTC DRUG Outpain Acontium napellus, apis mellifica, arnica, bryonia, calendula officinalis, camphora, hamamelis, phytolacca, rhus toxicodendron, symphitum CREAM TOPICAL 20170515 UNAPPROVED HOMEOPATHIC NARTEX LABORATORIOS HOMEOPATICOS SA DE CV ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA FLOWER; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CAMPHOR (NATURAL); HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; COMFREY ROOT .0123; 8; .0123; 4; 1; 3; .0123; 6; 6; 6 g/65g; [hp_X]/65g; g/65g; [hp_X]/65g; [hp_X]/65g; [hp_X]/65g; g/65g; [hp_X]/65g; [hp_X]/65g; [hp_X]/65g N 20181231 34690-3001_58a168f3-48bd-450a-91eb-d65845b0a836 34690-3001 HUMAN OTC DRUG Slimming Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 1.27 g/4g E 20171231 34690-3001_8c223786-e1e1-4883-88a0-2a51f53e5f55 34690-3001 HUMAN OTC DRUG Slimming Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 1.27 g/4g E 20171231 34690-3001_ad71f559-10be-4f2f-9a60-0fccfb5fa10d 34690-3001 HUMAN OTC DRUG Slimming Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 1.27 g/4g E 20171231 34690-3001_dc03bc2f-0ea0-4f39-b51e-c217b29b49c9 34690-3001 HUMAN OTC DRUG Slimming Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 1.27 g/4g E 20171231 34690-4001_060cd292-0950-4179-891d-3df6a1d363a5 34690-4001 HUMAN OTC DRUG Eucalyptus Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.94 g/4g E 20171231 34690-4001_1f0f7b19-70a3-4031-8ccc-9edd666a5cbf 34690-4001 HUMAN OTC DRUG Eucalyptus Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.94 g/4g E 20171231 34690-4001_7c0e00ff-9322-4eab-a004-9fc71d913f75 34690-4001 HUMAN OTC DRUG Eucalyptus Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.94 g/4g E 20171231 34690-4001_a90db06f-d9ac-4eb6-bd32-665839ba1490 34690-4001 HUMAN OTC DRUG Eucalyptus Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.94 g/4g E 20171231 34690-5001_2fdf7f24-eaed-487d-9a8b-2d7ae9a50f15 34690-5001 HUMAN OTC DRUG Rose Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-5001_3fb1f393-be1b-409d-935c-7687f89802b4 34690-5001 HUMAN OTC DRUG Rose Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-5001_4d748aec-d0cf-4540-bf0f-83cc6cf4338d 34690-5001 HUMAN OTC DRUG Rose Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-5001_c9d23b3b-50a7-4482-b429-10b2da6c59bc 34690-5001 HUMAN OTC DRUG Rose Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-6001_0447d13d-3174-4633-be30-e564254e13fd 34690-6001 HUMAN OTC DRUG Lavender Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-6001_816b01f2-dba5-4df3-a9b2-41935375e5ec 34690-6001 HUMAN OTC DRUG Lavender Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-6001_834e5e5e-f6c2-4e59-bdf6-3c6c9ab443d8 34690-6001 HUMAN OTC DRUG Lavender Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-6001_c6c08fe0-23b4-4384-96d8-aafc3a10df5e 34690-6001 HUMAN OTC DRUG Lavender Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-7001_152e9ea5-5484-420e-a890-904a37e1227e 34690-7001 HUMAN OTC DRUG Forest Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-7001_4e0b3f20-560e-436c-8344-ae853e6e651d 34690-7001 HUMAN OTC DRUG Forest Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-7001_6b731407-817d-4894-ad57-13083ae068cc 34690-7001 HUMAN OTC DRUG Forest Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-7001_d0911fde-2a9c-4fe7-a9a5-6a36e932867c 34690-7001 HUMAN OTC DRUG Forest Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-8001_0e330704-00e7-4b56-8cc8-0091a79b6112 34690-8001 HUMAN OTC DRUG Warm Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.95 g/4g E 20171231 34690-8001_9f558731-959d-45be-8ff3-5482008605c5 34690-8001 HUMAN OTC DRUG Warm Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.95 g/4g E 20171231 34690-8001_a187b082-8a65-4d67-9952-ad31b14dc3df 34690-8001 HUMAN OTC DRUG Warm Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.95 g/4g E 20171231 34690-8001_e6002281-0f9e-4576-8d46-72af2c6e52b4 34690-8001 HUMAN OTC DRUG Warm Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.95 g/4g E 20171231 34690-9001_441c4f76-47b7-49e7-b57b-907318e2c77b 34690-9001 HUMAN OTC DRUG Bamboo Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-9001_4e284585-f896-4f97-a8d6-ca565bb87f4c 34690-9001 HUMAN OTC DRUG Bamboo Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-9001_6ddb7a76-b6ca-4ff8-8324-16efb7d84e89 34690-9001 HUMAN OTC DRUG Bamboo Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34690-9001_9949e78a-85fe-4f14-a258-2dd23eb4cc89 34690-9001 HUMAN OTC DRUG Bamboo Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 KJI Industrial Co Ltd STARCH, CORN 2.92 g/4g E 20171231 34834-001_69d46896-35d7-40d8-8074-6aad143d7f61 34834-001 HUMAN OTC DRUG Merino Lip SPF 30 OCTINOXATE, OCTOCRYLENE, AVOBENZONE LIPSTICK TOPICAL 20031101 OTC MONOGRAPH FINAL part352 Merino Lanolin Skin Care Products OCTINOXATE; OCTOCRYLENE; AVOBENZONE 279; 185; 185 mg/4.5g; mg/4.5g; mg/4.5g E 20171231 34834-003_78a139c7-db51-4b6f-ad07-1b9462cced29 34834-003 HUMAN OTC DRUG Merino Collagen SPF 30 OCTINOXATE, OXYBENZONE CREAM TOPICAL 19970901 OTC MONOGRAPH FINAL part352 Merino Lanolin Skin Care Products OCTINOXATE; OXYBENZONE 7.5; 4 g/100g; g/100g E 20171231 34876-001_a8c16525-e350-46bc-83ba-31b6a2112a61 34876-001 HUMAN OTC DRUG Arthri-Zen Relief menthol CREAM TOPICAL 20070501 OTC MONOGRAPH NOT FINAL part348 RZN Nutraceuticals, Inc. MENTHOL 5 g/100g E 20171231 34908-620_18c346ed-a0da-462c-8f2c-53b4ff08b693 34908-620 HUMAN PRESCRIPTION DRUG LEVONEST levonorgestrel and ethinyl estradiol KIT ORAL 20110331 ANDA ANDA090719 Novast Laboratories, Ltd. N 20181231 34940-001_08033759-a891-4171-8ee6-daa2977b1320 34940-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20101108 NDA NDA205865 WAYNE OXYGEN AND WELDING SUPPLY COMPANY OXYGEN 990 L/L N 20181231 34940-002_5a73b114-8916-4085-ad7f-5641b3efdccf 34940-002 HUMAN PRESCRIPTION DRUG nitrogen nitrogen GAS RESPIRATORY (INHALATION) 20101108 NDA NDA205866 WAYNE OXYGEN AND WELDING SUPPLY COMPANY NITROGEN 990 L/L N 20181231 34954-008_26eaab39-4dbd-44cb-a17f-1e53f82447f4 34954-008 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 KIM CHEMICALS LTD. ISOPROPYL ALCOHOL 50 mL/100mL E 20171231 34954-010_7528c0e0-a94b-11de-8a39-0800200c9a66 34954-010 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 KIM CHEMICALS LTD. ISOPROPYL ALCOHOL 50 mL/100mL E 20171231 34954-013_038cb3b8-b145-46bf-9f30-4cf0d9028639 34954-013 HUMAN OTC DRUG Hot Ice Soothing Analgesic Gel Menthol GEL TOPICAL 20090921 OTC MONOGRAPH FINAL part341 Kim Chemicals LTD MENTHOL 2.27 g/227g E 20171231 34954-014_f8a0f33f-e733-423e-bb1d-15489a31c542 34954-014 HUMAN OTC DRUG Vaporizing Chest Rub Menthol Camphor Eucalyptus Oil GEL TOPICAL 20090921 OTC MONOGRAPH FINAL part341 Kim Chemicals LTD CAMPHOR; EUCALYPTUS OIL; MENTHOL 4.7; 1.1; 1.1 g/110g; g/110g; g/110g E 20171231 35000-002_aa086d70-6be1-42e5-bc89-cf77dd0f5476 35000-002 HUMAN OTC DRUG Colgate Total Whitening Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20100920 NDA NDA020231 Colgate-Palmolive SODIUM FLUORIDE; TRICLOSAN 1.4; 3 mg/g; mg/g N 20191231 35000-003_f5d54acd-3f7f-48cc-b3ba-803678af934c 35000-003 HUMAN OTC DRUG Colgate Total Whitening Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20100810 NDA NDA020231 Colgate-Palmolive SODIUM FLUORIDE; TRICLOSAN 1.4; 3 mg/g; mg/g N 20191231 35000-004_c0d7378c-c97e-4d6d-8d7c-0796df172a7e 35000-004 HUMAN OTC DRUG Colgate Total Advanced Fresh plus Whitening SODIUM FLUORIDE and TRICLOSAN PASTE, DENTIFRICE DENTAL 20100228 NDA NDA020231 Colgate-Palmolive SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g N 20191231 35000-008_8626e0c4-4f77-4ad9-ab43-c8f281908a4e 35000-008 HUMAN OTC DRUG Colgate Sparkling White CinnaMint Fluoride Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120827 OTC MONOGRAPH FINAL part355 Colgate-Palmolive SODIUM FLUORIDE 2.4 mg/g E 20171231 35000-013_bec87edc-f360-457b-b169-258984c81001 35000-013 HUMAN OTC DRUG Colgate MaxFresh with Mini Breath Clean Mint SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20131011 OTC MONOGRAPH FINAL part355 Colgate-Palmolive SODIUM FLUORIDE 1.4 mg/g N 20191231 35000-014_69f36c5b-e349-4f21-87a8-a8ba141b055f 35000-014 HUMAN OTC DRUG Colgate MaxFresh with Mini Breath Cool Mint SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130923 OTC MONOGRAPH FINAL part355 Colgate-Palmolive SODIUM FLUORIDE 1.4 mg/g N 20181231 35000-021_2e47ac0a-685c-4637-8f19-6577126b7d49 35000-021 HUMAN OTC DRUG Colgate Total Clean Mint Silicon Dioxide, Sodium Fluoride, and Triclosan PASTE, DENTIFRICE DENTAL 20101130 NDA NDA020231 Colgate-Palmolive Company SILICON DIOXIDE; SODIUM FLUORIDE; TRICLOSAN 50; 2.4; 3 mg/g; mg/g; mg/g N 20181231 35000-080_c9da2e0f-d344-4cf8-a735-5f3cb498e48c 35000-080 HUMAN OTC DRUG Colgate Max Clean Effervescent Mint Fluoride SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20150515 OTC MONOGRAPH FINAL part355 Colgate-Palmolive SODIUM FLUORIDE 2.4 mg/g E 20171231 35000-081_03b9fbbf-9959-465a-b755-5a22af16ca15 35000-081 HUMAN OTC DRUG SoftSoap Antibacterial with moisturizers White Tea and Berry Fusion Benzalkonium chloride LIQUID TOPICAL 20150520 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL N 20181231 35000-086_1d579e8f-0461-446c-892e-3177e008be25 35000-086 HUMAN OTC DRUG SoftSoap Antibacterial with moisturizers Crisp Clean Benzalkonium chloride LIQUID TOPICAL 20130119 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL N 20181231 35000-087_f333f5ed-94f8-41d1-97c8-25c267b842ad 35000-087 HUMAN OTC DRUG SoftSoap Antibacterial with moisturizers Fresh Citrus Benzalkonium chloride LIQUID TOPICAL 20130119 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL N 20181231 35000-114_4eab41ab-b493-4c46-a09d-699afab5f237 35000-114 HUMAN OTC DRUG Protex antibacterial Triclosan CREAM TOPICAL 20091209 OTC MONOGRAPH FINAL part333E Colgate Palmolive Company TRICLOSAN 1.5 mL/L E 20171231 35000-120_81132e39-33df-43db-bce3-7b0adae4584f 35000-120 HUMAN OTC DRUG Protex Deep Clean Triclocarban SOAP TOPICAL 20130603 20191231 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company TRICLOCARBAN 4 mg/g N 20181231 35000-161_93dae783-f321-47d4-80de-315541649f72 35000-161 HUMAN OTC DRUG Colgate Total Fresh Mint Stripe Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20130805 NDA NDA020231 Colgate-Palmolive SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g N 20181231 35000-163_43a715fe-52c3-4b84-b1bc-29bd406890e0 35000-163 HUMAN OTC DRUG Colgate Tartar Protection Whitening Fluoride Cool Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120829 OTC MONOGRAPH FINAL part355 Colgate-Palmolive SODIUM FLUORIDE 2.4 mg/g E 20171231 35000-168_598a3021-e66b-409d-b3a9-e36057ddc9d0 35000-168 HUMAN OTC DRUG Colgate Total Daily Repair Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20150401 NDA NDA020231 Colgate-Palmolive SODIUM FLUORIDE; TRICLOSAN 1.4; 3 mg/g; mg/g N 20181231 35000-205_8a26541e-68a3-4462-aca8-267b54b9379e 35000-205 HUMAN OTC DRUG Colgate Enamel Health Whitening SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20140617 OTC MONOGRAPH FINAL part355 Colgate-Palmolive SODIUM FLUORIDE 2.1 mg/g N 20191231 35000-206_95a871e0-4e57-4314-a386-4a9282914006 35000-206 HUMAN OTC DRUG Colgate Enamel Health Sensitivity Relief POTASSIUM NITRATE and SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20140630 OTC MONOGRAPH NOT FINAL part356 Colgate-Palmolive POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.4 mg/g; mg/g N 20191231 35000-207_2f03977e-0bad-41df-a545-a8745bb07786 35000-207 HUMAN OTC DRUG Colgate Enamel Health Sensitivity MultiProtect POTASSIUM NITRATE and SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20141209 OTC MONOGRAPH NOT FINAL part356 Colgate-Palmolive POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.4 mg/g; mg/g E 20171231 35000-209_906e22ce-4db6-454b-9fb7-3ec4cc52e218 35000-209 HUMAN OTC DRUG Colgate Enamel Health Mineral Repair POTASSIUM NITRATE and SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20151012 OTC MONOGRAPH NOT FINAL part356 Colgate-Palmolive POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.4 mg/g; mg/g N 20181231 35000-353_ed2ba530-3559-4a6f-8f54-7c7af4eccca9 35000-353 HUMAN OTC DRUG Colgate Total Advanced Deep Clean Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20071204 NDA NDA020231 Colgate-Palmolive SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g N 20191231 35000-354_c4d46a82-03bd-4644-b4b5-e38d34c4c240 35000-354 HUMAN OTC DRUG Colgate Total Advanced Whitening Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20100921 NDA NDA020231 Colgate-Palmolive SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g N 20181231 35000-364_33c47cd5-bd4b-4fc3-b3ab-c7dd1d7d6b74 35000-364 HUMAN OTC DRUG Colgate Total Advance Whitening Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20080809 NDA NDA020231 Colgate-Palmolive SODIUM FLUORIDE; TRICLOSAN 1.5; 3 mg/g; mg/g N 20191231 35000-383_9b4b4838-5a65-4a71-bded-8e3fb159de4e 35000-383 HUMAN OTC DRUG Colgate Kids Trolls Alcohol Free Anti-Cavity Sparkle Time Bubble Fruit SODIUM FLUORIDE RINSE DENTAL 20160805 OTC MONOGRAPH NOT FINAL part356 Colgate-Palmolive Company SODIUM FLUORIDE .1 mg/20mL N 20181231 35000-384_b9bcb365-d057-44ea-81d0-88753a2073c6 35000-384 HUMAN OTC DRUG Colgate Total Clean in Between Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20161018 NDA NDA020231 Colgate-Palmolive SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g N 20181231 35000-386_5c71b8ee-5c9c-4c36-9f74-f3176e4597e3 35000-386 HUMAN OTC DRUG Mens Speed Stick Overtime Odor Control with Charcoal - antiperspirant/deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20161116 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-387_17b2d4e1-4e68-4194-a601-817cff5de595 35000-387 HUMAN OTC DRUG Mens Speed Stick Irish Spring Celtic Ice - antiperspirant/deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20161117 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-388_e32f7eb1-f48b-4f0c-bff4-c3579ac1092c 35000-388 HUMAN OTC DRUG Mens Speed Stick Irish Spring Original - antiperspirant/deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20161117 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-389_c6505d61-ced4-4886-8d34-6da77961a0ba 35000-389 HUMAN OTC DRUG Enamel Health Multi-Protection Potassium Nitrate and Sodium Fluoride PASTE, DENTIFRICE DENTAL 20150612 OTC MONOGRAPH NOT FINAL part356 Colgate-Palmolive POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.4 mg/g; mg/g N 20191231 35000-390_592173d9-db97-44de-97f0-10103d7cd779 35000-390 HUMAN OTC DRUG Total Advanced Health Fresh Mint CETYLPYRIDINIUM CHLORIDE RINSE DENTAL 20170109 OTC MONOGRAPH NOT FINAL part356 Colgate-Palmolive Company CETYLPYRIDINIUM CHLORIDE .75 mg/mL N 20181231 35000-391_abed0d5d-9633-4905-926b-bb5f55a862ed 35000-391 HUMAN OTC DRUG Total Daily Repair SODIUM FLUORIDE RINSE DENTAL 20151207 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Company SODIUM FLUORIDE .1 mg/20mL N 20181231 35000-392_acdbd7a8-9502-47b4-8bf2-4e53b96b80ad 35000-392 HUMAN OTC DRUG Lady Speed Stick Unstoppable Charismatic - antiperspirant/deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20170315 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-393_22c3bc9e-ca47-4559-a948-cbc5b87c881a 35000-393 HUMAN OTC DRUG Lady Speed Stick Unstoppable Bold - antiperspirant/deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20170315 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-394_fcd62711-28a5-4a46-8122-c31dd4ee9d92 35000-394 HUMAN OTC DRUG Lady Speed Stick Unstoppable Irresistible - antiperspirant/deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20170315 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-396_ae35385d-1ed8-464d-a57b-b0b38d996a13 35000-396 HUMAN OTC DRUG Lady Speed Stick Double Defense Active Fresh - antiperspirant/deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20170309 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g N 20181231 35000-397_87105e0c-a281-42f8-8b18-404ad6f0826a 35000-397 HUMAN OTC DRUG Lady Speed Stick Double Defense Floral Fresh - antiperspirant/deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20170309 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g N 20181231 35000-407_91e629e6-4e74-4713-b734-10b44f67d9ff 35000-407 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Shower Fresh Antiperspirant Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20170325 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 158 mg/g N 20181231 35000-415_36d8674c-516e-42ea-86f2-451058eb6bc0 35000-415 HUMAN OTC DRUG Softsoap Antibacterial Wicked Citrus Benzalkonium chloride LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL N 20181231 35000-570_7d421673-3c8f-4fd6-9aae-db663d21981a 35000-570 HUMAN OTC DRUG Colgate Total Advanced Fresh plus Whitening Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20110812 NDA NDA020231 Colgate-Palmolive SODIUM FLUORIDE; TRICLOSAN 1.5; 3 mg/g; mg/g N 20181231 35000-581_06e2ce54-ef4c-4d9c-8cf3-053689ae2145 35000-581 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Power Powder Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20130203 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g N 20181231 35000-582_36765616-0e0d-42aa-8fce-6ae836eee4bc 35000-582 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Power Wild Freesia Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20130203 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g N 20181231 35000-583_6d7e2410-376d-4743-8e08-785984c57180 35000-583 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Power Spring Blossom Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20130203 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g N 20181231 35000-585_6d151a30-12a0-4960-85bd-6d030f5d046b 35000-585 HUMAN OTC DRUG Lady Speed Stick Clinical Proof pH active Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20130123 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 200 mg/g E 20171231 35000-586_10a56f61-65aa-4b60-afe5-0658b6f433e5 35000-586 HUMAN OTC DRUG Speed Stick Power Invigorate Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20130118 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-604_a2632043-3d88-42e3-8de6-32e8af8aaf48 35000-604 HUMAN OTC DRUG Softsoap Instant Hand Sanitizer with moisturizers Alcohol GEL TOPICAL 20130823 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company ALCOHOL 670 mL/1000mL E 20171231 35000-605_f6c640f4-02e2-4b5e-ace8-cf3c71c9de71 35000-605 HUMAN OTC DRUG Speed Stick Fresh Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20150903 OTC MONOGRAPH FINAL part350 Colgate-Palmolive ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 159 mg/g N 20181231 35000-606_2d57ecbe-9243-4e7b-bb96-84b37b48bfdc 35000-606 HUMAN OTC DRUG Speed Stick Clean Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20150903 OTC MONOGRAPH FINAL part350 Colgate-Palmolive ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 158 mg/g N 20181231 35000-608_f3f55e45-e049-46b2-a1af-d4fcbdb0fa1d 35000-608 HUMAN OTC DRUG Speed Stick Gametime Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20091209 OTC MONOGRAPH FINAL part350 Colgate Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g E 20171231 35000-618_16eadb9d-1a5f-44c8-b240-79f41154e432 35000-618 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Aloe Soothing Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101210 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g E 20171231 35000-622_a7c7fb70-bdf8-4004-9314-29f0b976af4b 35000-622 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101213 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g N 20181231 35000-623_cbb8812e-45f0-4809-8a71-d9bc92597487 35000-623 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Shower Fresh Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101207 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g N 20181231 35000-625_da169bb9-bfd0-4814-aa15-388172b1aea1 35000-625 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Wild Freesia Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110609 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g E 20171231 35000-626_76102dfd-6066-4522-877d-049d03037f67 35000-626 HUMAN OTC DRUG SPEED STICK CRISP CUCUMBER Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101208 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g E 20171231 35000-639_2528355b-a3b4-499b-9a14-120afd278ac2 35000-639 HUMAN OTC DRUG Speed Stick Teen Spirit Sweet Stawberry Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101208 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g E 20171231 35000-643_d9fefd75-9781-4740-acdf-8bf17d2837df 35000-643 HUMAN OTC DRUG Lady Speed Stick Teen Spirit Berry Blossom Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20090615 OTC MONOGRAPH FINAL part350 Colgate Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 159 mg/g E 20171231 35000-662_f0933c8b-601c-4cd3-b2ad-5f2c7dbbc3bb 35000-662 HUMAN OTC DRUG Speed Stick 24/7 Fresh Rush Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101210 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g E 20171231 35000-664_c7795802-fd8d-4901-b087-b731b3abbacf 35000-664 HUMAN OTC DRUG Speed Stick Cool Fusion Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g E 20171231 35000-670_ba29bd98-c7e7-48cc-b72a-33611879687e 35000-670 HUMAN OTC DRUG Speed Stick Unscented Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20110801 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-674_dcb84b7e-8696-4d77-8fd1-815e3e6982c9 35000-674 HUMAN OTC DRUG Speed Stick Sport Talc Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101207 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g E 20171231 35000-675_3207ebc0-3304-4bd8-8c04-e5f1d5d93fb7 35000-675 HUMAN OTC DRUG Protex Balance antibacterial hand Benzalkonium chloride LIQUID TOPICAL 20130822 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL N 20181231 35000-677_e1c14256-5631-4da5-94c6-9ccc1b237312 35000-677 HUMAN OTC DRUG SoftSoap Antibacterial Kitchen Fresh Hands Benzalkonium chloride LIQUID TOPICAL 20160819 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL N 20181231 35000-700_c72b92a6-3298-4de0-8ac4-585ae97cef48 35000-700 HUMAN OTC DRUG Speed Stick Irish Spring Icy Blast Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110609 OTC MONOGRAPH FINAL part350 Colgate Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g E 20171231 35000-701_7bee99c3-c6aa-46d1-be15-92daffb262f1 35000-701 HUMAN OTC DRUG Speed Stick Irish Spring Original Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110609 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g E 20171231 35000-702_7e20c0b7-3cf2-446b-9a50-7583ef1af3aa 35000-702 HUMAN OTC DRUG Irish Spring Legendary Classic Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110609 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g E 20171231 35000-703_dba54bf7-c0d1-43b5-a9da-10385ec65271 35000-703 HUMAN OTC DRUG Lady Speed Stick Enchanted Cherry Blossom Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110609 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 159 mg/g E 20171231 35000-704_5a675625-579d-4fa6-9af9-eabe84098e0a 35000-704 HUMAN OTC DRUG Lady Speed Stick Stainguard Silky Chiffon Scent Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 100 mg/g E 20171231 35000-711_2790e304-aeba-4856-a499-e3fb21469e13 35000-711 HUMAN OTC DRUG Lady Speed Stick Teen Spirit Pink Crush Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101210 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 159 mg/g N 20181231 35000-711_a706b8d1-0c24-4a81-8a55-232c43388465 35000-711 HUMAN OTC DRUG Lady Speed Stick Teen Spirit Pink Crush Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101210 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 159 mg/g N 20181231 35000-714_c751c922-5cc1-4c1c-878a-35ef4ebebc00 35000-714 HUMAN OTC DRUG Lady Speed Stick Fresh Fusion Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101210 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g E 20171231 35000-715_61c14b37-d383-426f-a504-8915f1e13520 35000-715 HUMAN OTC DRUG Lady Speed Stick Satin Pear Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101208 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g N 20181231 35000-716_be7fdf5b-5104-478c-80ce-142151f0f88d 35000-716 HUMAN OTC DRUG Lady Speed Stick 24x7 Powder Burst Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110609 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g N 20181231 35000-720_e3ee25ad-6094-4af9-9cf4-70c120f456dc 35000-720 HUMAN OTC DRUG Colgate Total Advanced Pro-Shield Peppermint Blast CETYLPYRIDINIUM CHLORIDE RINSE DENTAL 20130506 OTC MONOGRAPH NOT FINAL part356 Colgate-Palmolive Company CETYLPYRIDINIUM CHLORIDE 15 mg/20mL N 20181231 35000-721_79750724-87a5-4eb9-b32d-3676463dde58 35000-721 HUMAN OTC DRUG Colgate Total Advanced Pro-Shield Spearmint Surge CETYLPYRIDINIUM CHLORIDE RINSE DENTAL 20130506 OTC MONOGRAPH NOT FINAL part356 Colgate-Palmolive Company CETYLPYRIDINIUM CHLORIDE 15 mg/20mL N 20181231 35000-722_b154088e-a38e-4665-9e23-c14af46f02a8 35000-722 HUMAN OTC DRUG Colgate Total Advanced Pro-Shield Wintermint Rush Cetylpyridinium chloride RINSE DENTAL 20130506 OTC MONOGRAPH NOT FINAL part356 Colgate-Palmolive Company CETYLPYRIDINIUM CHLORIDE 15 mg/20mL N 20181231 35000-723_647f75de-82bf-4ef2-9a80-f8c1cb97f663 35000-723 HUMAN OTC DRUG Colgate Total Advanced Gum Health Mouthwash CETYLPYRIDINIUM CHLORIDE RINSE DENTAL 20150301 OTC MONOGRAPH NOT FINAL part356 Colgate-Palmolive Company CETYLPYRIDINIUM CHLORIDE .75 mg/mL N 20181231 35000-724_d6748403-43db-4f66-8ae3-5c5e2565e18b 35000-724 HUMAN OTC DRUG Colgate Total Lasting White Polar Freshmint SODIUM FLUORIDE RINSE DENTAL 20140801 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Company SODIUM FLUORIDE .1 mg/mL N 20181231 35000-725_253b6909-1cda-4d2f-9a1b-d42078b97a36 35000-725 HUMAN OTC DRUG Colgate Kids Bubblegum Swirl SODIUM FLUORIDE RINSE DENTAL 20140801 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Company SODIUM FLUORIDE .1 mg/mL N 20181231 35000-726_8f77b629-7627-44ce-abb8-ddea7ec8ed72 35000-726 HUMAN OTC DRUG Colgate Kids Bubblefruit SODIUM FLUORIDE RINSE DENTAL 20140801 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Company SODIUM FLUORIDE .1 mg/mL N 20181231 35000-727_02ef7164-f85e-4f48-8179-3e6060f3b5e2 35000-727 HUMAN OTC DRUG Colgate Kids Minions Mouthwash SODIUM FLUORIDE RINSE DENTAL 20150801 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Company SODIUM FLUORIDE .1 mg/mL N 20181231 35000-728_10288058-e52c-4363-aa4f-f99264309d55 35000-728 HUMAN OTC DRUG Colgate Enamel Health Mouthwash SODIUM FLUORIDE RINSE DENTAL 20150801 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Company SODIUM FLUORIDE .1 mg/mL N 20181231 35000-729_758e2d30-8a46-4d63-8c25-713cdc5ac936 35000-729 HUMAN OTC DRUG Speed Stick Gear Overtime Relentless Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20151022 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 153 mg/g N 20181231 35000-730_b8c887fa-9250-4502-8cc5-c3fec37a39f5 35000-730 HUMAN OTC DRUG Speed Stick Gear Overtime Invigorate Antiperspirant Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20151022 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 153 mg/g N 20181231 35000-731_951712a3-44f6-4dce-bb6f-8723a58e2148 35000-731 HUMAN OTC DRUG Colgate Total 12 Hr Pro-Shield Spearmint Surge CETYLPYRIDINIUM CHLORIDE RINSE DENTAL 20150901 OTC MONOGRAPH NOT FINAL part356 Colgate-Palmolive Company CETYLPYRIDINIUM CHLORIDE 15 mg/20mL N 20181231 35000-732_d78cfec5-3585-44a9-9686-865dc332076a 35000-732 HUMAN OTC DRUG Colgate Total 12Hr Pro-Shield Peppermint Blast CETYLPYRIDINIUM CHLORIDE RINSE DENTAL 20151001 OTC MONOGRAPH NOT FINAL part356 Colgate-Palmolive Company CETYLPYRIDINIUM CHLORIDE 15 mg/20mL N 20181231 35000-733_d520c254-df18-4408-aec7-3e3a782c1662 35000-733 HUMAN OTC DRUG SoftSoap Antibacterial Hand Citrus Cheer Benzalkonium chloride LIQUID TOPICAL 20170915 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL N 20181231 35000-818_21c2c600-52d8-4eb2-a2bc-619b3983a849 35000-818 HUMAN OTC DRUG Softsoap foaming hand sanitizer with light moisturizers Benzalkonium Chloride LIQUID TOPICAL 20100426 OTC MONOGRAPH NOT FINAL part333E Colgate Palmolive Company BENZALKONIUM CHLORIDE 1 mL/L E 20171231 35000-834_bb79e78b-20bd-4d32-be20-cb0ffe8b082f 35000-834 HUMAN OTC DRUG Protex Oats Triclocarban LIQUID TOPICAL 20100211 OTC MONOGRAPH NOT FINAL part333E Colgate Palmolive Company TRICLOCARBAN 1.5 mL/L E 20171231 35000-842_45ab7a59-9efe-4fd3-9124-45ce696a5156 35000-842 HUMAN OTC DRUG Speed Stick Pro Extra Dry Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20090615 OTC MONOGRAPH FINAL part350 Colgate Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 172 mg/g E 20171231 35000-844_63988843-e85e-4b0f-88a3-390449062b6e 35000-844 HUMAN OTC DRUG Ladies Speed Stick 24/7 Smooth Perfection Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20101208 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 151 mg/g E 20171231 35000-845_8482cf25-1d6e-4acc-a53a-7d051f3043be 35000-845 HUMAN OTC DRUG Lady Speed Stick Stainguard Powder Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 100 mg/g N 20181231 35000-846_0a9313b8-ac99-4fbf-a137-0379602f4f28 35000-846 HUMAN OTC DRUG Lady Speed Stick Stainguard Daringly Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 100 mg/g N 20181231 35000-847_3145ec8e-e81b-4121-8085-333a63371135 35000-847 HUMAN OTC DRUG Speed Stick Stainguard Clean Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 100 mg/g E 20171231 35000-848_b269bde3-18b2-47e6-96cc-214387a38277 35000-848 HUMAN OTC DRUG Speed Stick Stainguard Fresh Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20111012 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 100 mg/g N 20181231 35000-850_b07df577-a326-49f8-b7da-63ed9e22f98f 35000-850 HUMAN OTC DRUG Protex BALANCE ANTIBACTERIAL HAND Triclocarban LIQUID TOPICAL 20110610 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company TRICLOCARBAN 1.5 mg/1000mL E 20171231 35000-853_56936e51-bed5-4e76-88f7-cb366691ad67 35000-853 HUMAN OTC DRUG Softsoap Aquatic Splash Antibacterial with light Moisturizers Triclosan LIQUID TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company TRICLOSAN 1.5 mL/L E 20171231 35000-854_05541bc1-8800-40ab-ba4f-e0dfacda26ac 35000-854 HUMAN OTC DRUG Speed Stick Power Ultimate Sport Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110801 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g N 20181231 35000-855_52b11242-54d2-4a60-a0b2-a9d58d51146a 35000-855 HUMAN OTC DRUG Lady Speed Stick 24/7 Fresh Fusion Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g N 20181231 35000-856_20bbbde3-ca09-40d6-b09c-51e4ad7a1979 35000-856 HUMAN OTC DRUG Lady Speed Stick Invisible Dry Shower Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g N 20181231 35000-857_80766e01-6b0b-412c-bda4-6d603703e969 35000-857 HUMAN OTC DRUG Lady Speed Stick 24/7 Powder Burst Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g E 20171231 35000-858_4d3aaf76-3190-4a26-af6e-b62fe40ab3ec 35000-858 HUMAN OTC DRUG Speed Stick 24/7 Gametime Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g E 20171231 35000-859_e7b91348-46b6-4cba-a260-22e7ab7d815b 35000-859 HUMAN OTC DRUG Speed Stick 24/7 Cool Fusion Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g E 20171231 35000-860_4476c220-8dfc-45cc-aecd-b3deda0e7583 35000-860 HUMAN OTC DRUG Speed Stick 24/7 Fresh Rush Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g N 20181231 35000-861_0e5da41d-accf-401f-b4fc-d26e8a1dc535 35000-861 HUMAN OTC DRUG Speed Stick Power Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110801 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g E 20171231 35000-862_02ab04a0-6d74-4e31-a607-105daabd3952 35000-862 HUMAN OTC DRUG Speed Stick Irish Spring Icy Blast Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-865_91481049-490a-4ecf-ac3a-b6d78da38c22 35000-865 HUMAN OTC DRUG Speed Stick Sport Talc Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g E 20171231 35000-867_52aebfba-beb3-4343-a564-fa98de2911cb 35000-867 HUMAN OTC DRUG Speed Stick Irish Spring Original Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111204 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-868_17cb6e02-77b7-4774-b9f5-8f21804769e0 35000-868 HUMAN OTC DRUG Lady Speed Stick Fresh Infusions Sparkling Lime Coconut Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20120117 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 154 mg/g E 20171231 35000-869_789d40dd-b4c7-4516-8180-d3b94d1c16f5 35000-869 HUMAN OTC DRUG Speed Stick Power Energy Surge Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110801 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g E 20171231 35000-870_578d8b7c-c60f-46d8-b632-ebfa8cbe7fd4 35000-870 HUMAN OTC DRUG Speed Stick Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20111207 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g E 20171231 35000-871_1418b7d9-0b2a-442a-8239-1a102f68142e 35000-871 HUMAN OTC DRUG Speed Stick Power Fresh Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20110801 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-872_adb81fd0-8c09-4f36-9fdd-cf810f94e579 35000-872 HUMAN OTC DRUG Speed Stick Power Ultimate Sport Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20120626 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-873_f96759a2-4a1a-4457-92be-55a014e4bc68 35000-873 HUMAN OTC DRUG Irish Spring Body Wash Clear and Fresh Skin Salicylic acid LIQUID TOPICAL 20120626 OTC MONOGRAPH FINAL part333D Colgate-Palmolive Company SALICYLIC ACID 20 mL/L E 20171231 35000-874_e615e190-e750-4e2d-ba11-163596c9e549 35000-874 HUMAN OTC DRUG Softsoap Aquatic Splash Antibacterial with light Moisturizers Benzalkonium chloride LIQUID TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part333E Colgate Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL E 20171231 35000-875_2f9c5076-4edb-45ca-a714-3826bd64fd74 35000-875 HUMAN OTC DRUG SoftSoap Antiseptic Hand Wash Benzalkonium chloride LIQUID TOPICAL 20130808 OTC MONOGRAPH NOT FINAL part333E Colgate-Palmolive Company BENZALKONIUM CHLORIDE 1.33 mg/mL E 20171231 35000-876_3d451513-cdb5-4eb6-aeab-e896e524f040 35000-876 HUMAN OTC DRUG Speed Stick Gear Fresh Force Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-877_0e592898-a0b0-4b74-b0ef-fed26e05efca 35000-877 HUMAN OTC DRUG Speed Stick Gear Fresh Force Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g N 20181231 35000-878_ee330b72-a2c5-4076-8937-b30ac37ceb6e 35000-878 HUMAN OTC DRUG Speed Stick Gear Clean Peak Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35000-879_588328c9-11b1-4f6a-bb6c-99ceefe5aeac 35000-879 HUMAN OTC DRUG Speed Stick Gear Cool Motion Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 Colgate-Palmolive Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 35038-200_4c3957e1-7f64-468e-9f83-23e74802abab 35038-200 HUMAN OTC DRUG ASSURED ACNE CREAM ACNE CREAM CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part333D HANGZHOU MINO DAILY CHEMICALS CO.LTD. SALICYLIC ACID .5 mL/100mL E 20171231 35192-002_9e27a24a-d6dc-4d76-af32-f80588ae7b53 35192-002 HUMAN OTC DRUG PAIN RELIEVER MENTHOL GEL TOPICAL 20110824 OTC MONOGRAPH NOT FINAL part348 CA-BOTANA INTERNATIONAL MENTHOL 2.4 g/120g E 20171231 35192-005_6e2ff42f-edbc-4526-9f86-33cdb8c93d1e 35192-005 HUMAN OTC DRUG Astringent Aluminum Acetate GEL TOPICAL 20150101 OTC MONOGRAPH FINAL part347 CA-BOTANA INTERNATIONAL ALUMINUM ACETATE .008 mg/4mL E 20171231 35192-006_5e651d2d-7b9b-4ef7-864d-a632b06fdd9e 35192-006 HUMAN OTC DRUG Shimmery Sun Octinoxate Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 5.67; 4.53 g/113.4g; g/113.4g E 20171231 35192-007_5d179ebe-ea4b-8ed5-e053-2991aa0ad7f7 35192-007 HUMAN OTC DRUG UMBRELLA OCTINOXATE TITANIUM DIOXIDE LOTION TOPICAL 20130801 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 2.268; 2.268 g/56.7g; g/56.7g N 20181231 35192-008_504333a6-c975-42e9-b6f8-90fcc2788f71 35192-008 HUMAN OTC DRUG Sunscreen SPF 40 LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL TITANIUM DIOXIDE; OCTINOXATE 6.8; 8.5 g/113.4g; g/113.4g E 20171231 35192-009_00031d79-af7f-4257-a385-c0b17e617cad 35192-009 HUMAN OTC DRUG Sun Essential Octinoxate Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 17.75; 14.2 g/355g; g/355g E 20171231 35192-009_9c7c3ae2-0f21-4e58-810f-8a661936f405 35192-009 HUMAN OTC DRUG Sun Essential Octinoxate Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 1.5; 1.2 g/30g; g/30g E 20171231 35192-010_5d91c1cf-1464-5aa9-e053-2991aa0a5c4a 35192-010 HUMAN OTC DRUG Umbrella Sunscreen Octinoxate Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL TITANIUM DIOXIDE; OCTINOXATE 6.8; 8.5 g/113.4g; g/113.4g N 20181231 35192-011_5d18e4e0-2b99-9e72-e053-2991aa0aae37 35192-011 HUMAN OTC DRUG ULTRA UMBRELLA OCTINOXATE TITANIUM DIOXIDE LOTION TOPICAL 20130801 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 4.536; 4.536 g/113.4g; g/113.4g N 20181231 35192-012_5d6908ba-006e-5add-e053-2991aa0a0167 35192-012 HUMAN OTC DRUG Shimmery Sun Octinoxate Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 4.536; 5.67 g/113.4g; g/113.4g N 20181231 35192-013_22c78a5c-9ecd-405a-bc0e-6a06e55be275 35192-013 HUMAN OTC DRUG Umbrella Sunscreen Octinoxate Titanium Dioxide LOTION TOPICAL 20131010 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL TITANIUM DIOXIDE; OCTINOXATE 3; 3.75 g/50g; g/50g E 20171231 35192-014_7090373b-0b23-435f-8a24-1ea41c6dc144 35192-014 HUMAN OTC DRUG Shimmery Sun Octinoxate Titanium Dioxide LOTION TOPICAL 20131010 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 2; 2.5 g/113.4g; g/113.4g E 20171231 35192-016_5d06c396-1296-4ecc-e053-2991aa0a6467 35192-016 HUMAN OTC DRUG Controlling balm with tea tree oil SALICYLIC ACID EMULSION TOPICAL 20141109 OTC MONOGRAPH FINAL part358H CA-BOTANA INTERNATIONAL SALICYLIC ACID .24 mg/29.6mg N 20181231 35192-017_5d062451-ad54-29d7-e053-2a91aa0a2d77 35192-017 HUMAN OTC DRUG Controlling Cream BENZOYL PEROXIDE CREAM TOPICAL 20141109 OTC MONOGRAPH FINAL part333D CA-BOTANA INTERNATIONAL BENZOYL PEROXIDE .8 mg/29.6mg N 20181231 35192-018_5d037713-5c08-a96c-e053-2991aa0a913d 35192-018 HUMAN OTC DRUG Controlling balm with tea tree oil SALICYLIC ACID EMULSION TOPICAL 20141109 OTC MONOGRAPH FINAL part358H CA-BOTANA INTERNATIONAL SALICYLIC ACID 1.89 mg/237mg N 20181231 35192-020_5bc28280-daad-3293-e053-2a91aa0ad4f9 35192-020 HUMAN OTC DRUG Weh-Weh Pain reliever gel Menthol GEL TOPICAL 20160131 OTC MONOGRAPH NOT FINAL part348 CA-BOTANA INTERNATIONAL MENTHOL 6 g/120g N 20181231 35192-022_0df2af94-513c-40b6-a717-681f9b8a63e2 35192-022 HUMAN OTC DRUG Sun Defense Cream OCTINOXATE TITANIUM DIOXIDE LOTION TOPICAL 20150901 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE .372; .372 g/.375g; g/.375g E 20171231 35192-023_5bc422e7-68eb-2317-e053-2a91aa0a095a 35192-023 HUMAN OTC DRUG Weh-Weh Natural Pain relief oil Capsaicin OIL TOPICAL 20160131 OTC MONOGRAPH NOT FINAL part348 CA-BOTANA INTERNATIONAL CAPSAICIN .075 g/50g N 20181231 35192-024_5bc4529a-58b6-710c-e053-2991aa0abb0b 35192-024 HUMAN OTC DRUG Sun defense CanyonRanch Titanium Dioxide,Octinoxate EMULSION TOPICAL 20160101 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL TITANIUM DIOXIDE; OCTINOXATE 5.9; 4.7 g/118g; g/118g N 20181231 35192-025_5bc21ba9-e2fb-b442-e053-2a91aa0a2898 35192-025 HUMAN OTC DRUG Sun Defense Canyon Ranch Titanium Dioxide, Octinoxate EMULSION TOPICAL 20160815 OTC MONOGRAPH FINAL part352 CA-Botana International OCTINOXATE; TITANIUM DIOXIDE 18.92; 23.65 g/473g; g/473g N 20181231 35192-026_5bc019b5-79fc-122b-e053-2991aa0a4ccc 35192-026 HUMAN OTC DRUG Kope Pain relief gel Lidocaine GEL TOPICAL 20170630 OTC MONOGRAPH NOT FINAL part348 CA-BOTANA INTERNATIONAL LIDOCAINE 4 g/50g N 20181231 35192-027_5cda3210-5531-22a7-e053-2991aa0a57aa 35192-027 HUMAN OTC DRUG Kope Pain relief gel Lidocaine GEL TOPICAL 20170715 OTC MONOGRAPH NOT FINAL part348 CA-BOTANA INTERNATIONAL LIDOCAINE 4 g/50g N 20181231 35192-028_5d57b017-7eca-4db7-e053-2991aa0aa018 35192-028 HUMAN OTC DRUG Suncreen Daily Defense Lather Titanium Dioxide,Octinoxate EMULSION TOPICAL 20171106 OTC MONOGRAPH FINAL part352 CA-BOTANA INTERNATIONAL TITANIUM DIOXIDE; OCTINOXATE 2.95; 2.36 g/59g; g/59g N 20181231 35208-001_d57aa651-b731-4f51-9324-85ce7cc01309 35208-001 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Extended Release Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170601 ANDA ANDA202306 IntelliPharmaCeutics Corp. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 35208-002_d57aa651-b731-4f51-9324-85ce7cc01309 35208-002 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Extended Release Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170601 ANDA ANDA202306 IntelliPharmaCeutics Corp. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 35208-031_b0da0932-ad12-458d-b4de-5d1174cff448 35208-031 HUMAN PRESCRIPTION DRUG Levetiracetam Extended-release Levetiracetam TABLET, EXTENDED RELEASE ORAL 20161003 ANDA ANDA204511 IntelliPharmaCeutics Corp. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 35208-032_b0da0932-ad12-458d-b4de-5d1174cff448 35208-032 HUMAN PRESCRIPTION DRUG Levetiracetam Extended-release Levetiracetam TABLET, EXTENDED RELEASE ORAL 20161003 ANDA ANDA204511 IntelliPharmaCeutics Corp. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 35356-004_96a0d964-326c-480c-996e-9af32ca3b352 35356-004 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride TABLET SUBLINGUAL 20111110 NDA NDA020733 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII E 20171231 35356-012_b4f81398-a298-4d96-b62c-4f9759850628 35356-012 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate TABLET, FILM COATED ORAL 20120223 NDA NDA021928 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] E 20171231 35356-017_a3bdb68c-845d-4e23-a8e3-5684214df294 35356-017 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET ORAL 20101109 ANDA ANDA065405 Lake Erie Medical DBA Quality Care Products LLC AZITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 35356-032_266fd4b9-3223-4465-8b38-6cc6d3f72726 35356-032 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20110219 ANDA ANDA076119 Lake Erie Medical DBA Quality Care Products LLC MIRTAZAPINE 45 mg/1 E 20171231 35356-033_d64f27e4-4f5e-40d1-b3aa-1101d95fc431 35356-033 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111219 NDA AUTHORIZED GENERIC NDA019839 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 35356-043_90cf6728-50da-48ae-a3c9-4b9b45170f92 35356-043 HUMAN PRESCRIPTION DRUG Zonalon doxepin hydrochloride CREAM TOPICAL 20120330 NDA NDA020126 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DOXEPIN HYDROCHLORIDE 50 mg/g Tricyclic Antidepressant [EPC] E 20171231 35356-044_560aec45-8cf3-42c1-b930-e3b21d4cba9a 35356-044 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 20170913 NDA AUTHORIZED GENERIC NDA050710 Lake Erie Medical DBA Quality Care Products LLC AZITHROMYCIN DIHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 35356-046_f0349923-d260-41e1-a96f-194ffcb2c4b7 35356-046 HUMAN PRESCRIPTION DRUG CELEXA citalopram hydrobromide TABLET, FILM COATED ORAL 20111117 NDA NDA020822 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 35356-053_9c3cc965-5bbd-47bb-b082-8a0f1e658ea6 35356-053 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20110718 NDA NDA021724 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC PREGABALIN 25 mg/1 CV N 20181231 35356-053_deba1918-6f42-4df2-989f-fe782275b58a 35356-053 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20120319 NDA NDA021724 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PREGABALIN 25 mg/1 CV N 20181231 35356-054_a1e4507e-6bc6-4225-bb66-db6069202261 35356-054 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20120206 NDA AUTHORIZED GENERIC NDA021724 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PREGABALIN 150 mg/1 N 20181231 35356-059_80b1a179-b9ea-4a7f-9006-e5a3fd63348d 35356-059 HUMAN PRESCRIPTION DRUG Amlodipine Besylate AMLODIPINE BESYLATE TABLET ORAL 20110221 ANDA ANDA078925 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 35356-059_9bcbe9e4-a541-4ee7-856d-1aacf7f7298f 35356-059 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20101104 ANDA ANDA078925 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 35356-062_c7274269-63db-46ba-a397-13064c625fb5 35356-062 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20130109 ANDA ANDA076258 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 12 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-070_85533da6-7829-44c8-906a-d8c499cf0a2c 35356-070 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20040802 NDA NDA021752 Lake Erie Medical DBA Quality Care Products LLC EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 35356-077_27fab972-7b99-46da-b13e-d08bd70fd180 35356-077 HUMAN PRESCRIPTION DRUG FLECTOR DICLOFENAC EPOLAMINE PATCH TOPICAL 20111111 NDA NDA021234 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DICLOFENAC EPOLAMINE 180 mg/14g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-118_c0d14587-f4b3-4786-bb37-b5faebcf1a27 35356-118 HUMAN PRESCRIPTION DRUG AVINZA morphine sulfate CAPSULE, COATED, EXTENDED RELEASE ORAL 20111025 NDA NDA021260 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-125_4e71b4f5-5545-440e-98de-365dfbfb353f 35356-125 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Lake Erie Medical DBA Quality Care Products LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 35356-141_dfb614d7-647d-4682-a41b-13d5a8076fcd 35356-141 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine CAPSULE ORAL 20100713 NDA NDA021411 Lake Erie Medical DBA Quality Care Products LLC ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 35356-166_298c05d9-277f-428f-b502-fa44fdb67923 35356-166 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 35356-174_b4f81398-a298-4d96-b62c-4f9759850628 35356-174 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate TABLET, FILM COATED ORAL 20120223 NDA NDA021928 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] E 20171231 35356-175_b4f81398-a298-4d96-b62c-4f9759850628 35356-175 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate KIT 20060510 NDA NDA021928 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC E 20171231 35356-211_a3a4f2a2-0445-4c5c-8c1b-f8b6cc39ebdb 35356-211 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET ORAL 20120214 ANDA ANDA077290 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-212_455b6474-99cb-424c-be4e-5496344a8a0c 35356-212 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20111220 ANDA ANDA077290 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-262_23bf2785-8ee7-4c37-a4d8-dc520b107602 35356-262 HUMAN PRESCRIPTION DRUG Amrix Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120103 NDA NDA021777 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 35356-303_ebd6ebfb-bfc5-40be-a2a4-5e169d8bca02 35356-303 HUMAN PRESCRIPTION DRUG Prandin Repaglinide TABLET ORAL 20101012 NDA NDA020741 Lake Erie Medical DBA Quality Care Products LLC REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 35356-317_3678805c-0cff-4b6d-9d1a-0aaee7718b74 35356-317 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20120712 NDA NDA020592 Lake Erie Medical DBA Quality Care Products LLC OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 35356-324_f0c467f6-bd22-4c7a-b66b-4634169e389c 35356-324 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20120306 ANDA ANDA076174 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-325_f8200669-8573-4684-8224-d5cccb5cc33b 35356-325 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20111206 ANDA ANDA040120 Lake Erie Medical & Surgical Supply DBA Quality Care Prodcuts LLC PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 35356-333_c0d14587-f4b3-4786-bb37-b5faebcf1a27 35356-333 HUMAN PRESCRIPTION DRUG AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111025 NDA NDA021260 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 90 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-339_c0d14587-f4b3-4786-bb37-b5faebcf1a27 35356-339 HUMAN PRESCRIPTION DRUG AVINZA morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20111025 NDA NDA021260 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 120 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-341_997193e1-d59a-474c-a574-a4e3dd3db2db 35356-341 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL 20120328 NDA NDA021447 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 35356-342_997193e1-d59a-474c-a574-a4e3dd3db2db 35356-342 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL 20120328 NDA NDA021447 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 35356-372_a1b9e82a-4389-44b9-ab7b-49c540ff1732 35356-372 HUMAN PRESCRIPTION DRUG PROVIGIL modafinil TABLET ORAL 20110720 NDA NDA020717 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 35356-380_404fbf7a-3245-446b-88bf-8e425456c5dc 35356-380 HUMAN PRESCRIPTION DRUG OPANA Oxymorphone Hydrochloride TABLET ORAL 20120209 NDA NDA021611 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-387_66ba49b4-bccc-45e1-8a2f-16ca204e17e6 35356-387 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate TABLET ORAL 20111207 ANDA ANDA040361 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 35356-398_dc2675ec-e5f2-4ee7-baaf-e5a6859a182d 35356-398 HUMAN PRESCRIPTION DRUG Lyrica Pregabalin CAPSULE ORAL 20100813 NDA NDA021724 Lake Erie Medical DBA Quality Care Products LLC PREGABALIN 300 mg/1 CV N 20181231 35356-413_a6cdb652-f16b-4266-92a8-d5b352b0b22f 35356-413 HUMAN PRESCRIPTION DRUG Crestor Rosuvastatin calcium TABLET, COATED ORAL 20100908 NDA NDA021366 Lake Erie Medical DBA Quality Care Products LLC ROSUVASTATIN CALCIUM 40 mg/1 N 20181231 35356-419_6ca39a60-a09c-4d77-867c-47a4620e344f 35356-419 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20110415 ANDA ANDA040750 Lake Erie Medical DBA Quality Care Products LLC SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 35356-438_99eb293b-7024-4480-a2e1-c4f4cc3ff67c 35356-438 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Lake Erie Medical DBA Quality Care Products LLC SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 35356-439_99eb293b-7024-4480-a2e1-c4f4cc3ff67c 35356-439 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Lake Erie Medical DBA Quality Care Products LLC SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 35356-445_6ca04926-5847-4179-82ae-93c34db7d756 35356-445 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20111103 ANDA ANDA076252 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 35356-446_997193e1-d59a-474c-a574-a4e3dd3db2db 35356-446 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride CAPSULE ORAL 20120328 NDA NDA021447 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 35356-462_c18183b9-bbd6-436d-b740-607f79010761 35356-462 HUMAN PRESCRIPTION DRUG Xyzal Levocetirizine dihydrochloride TABLET, FILM COATED ORAL 20100810 NDA NDA022064 Lake Erie Medical DBA Quality Care Products LLC LEVOCARNITINE HYDROCHLORIDE 5 mg/1 Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] E 20171231 35356-473_1c53e450-9c25-4e7b-912b-58989a059e64 35356-473 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20100713 ANDA ANDA076570 Lake Erie Medical DBA Quality Care Products LLC TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 35356-491_e741d2cb-7ec7-4b8c-9f5c-5e2b367a9b87 35356-491 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20120416 NDA NDA021992 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 35356-499_404fbf7a-3245-446b-88bf-8e425456c5dc 35356-499 HUMAN PRESCRIPTION DRUG OPANA Oxymorphone Hydrochloride TABLET ORAL 20120209 NDA NDA021611 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-500_41edd35f-8fe5-48d6-82c8-c4fe460a73b4 35356-500 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20110601 NDA NDA021908 Lake Erie Medical DBA Quality Care Products LLC LUBIPROSTONE 24 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] N 20181231 35356-512_c8042b87-63ab-47d1-8359-9af500033b4d 35356-512 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Lake Erie Medical DBA Quality Care Products LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 35356-515_1328a5ca-1328-4461-86e6-e775d5f4f20b 35356-515 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021210 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 35356-521_4999f6bf-af7e-4c8f-ae91-48a2931be1dd 35356-521 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE EXTENDED-RELEASE MORPHINE SULFATE TABLET ORAL 20110728 ANDA ANDA076438 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-525_c3f61b6e-afc3-4b69-9302-be403d23cb0e 35356-525 HUMAN PRESCRIPTION DRUG Nucynta Tapentadol TABLET ORAL 20100929 NDA NDA022304 Lake Erie Medical DBA Quality Care Products LLC TAPENTADOL 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 35356-526_c8042b87-63ab-47d1-8359-9af500033b4d 35356-526 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Lake Erie Medical DBA Quality Care Products LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 35356-528_f3671457-c278-435c-ba53-e8fad743b41a 35356-528 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE EXTENDED-RELEASE MORPHINE SULFATE TABLET ORAL 20120320 ANDA ANDA076438 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-533_5a9345bb-8720-4184-aa87-35e09b538298 35356-533 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120123 ANDA ANDA078154 Lake Erie Medical DBA Quality Care Products LLC LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 35356-541_117b4f2b-98e3-490e-8c1f-21a45a8675bf 35356-541 HUMAN PRESCRIPTION DRUG Enalapril Maleate enalapril maleate TABLET ORAL 20000822 ANDA ANDA075480 Lake Erie Medical DBA Quality Care Products LLC ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 35356-542_8136ad04-d031-49f6-8f6b-0868f007ab84 35356-542 HUMAN OTC DRUG Terocin Methyl Salicylate, Capsaicin, Menthol and Lidocaine Hydrochloride LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METHYL SALICYLATE; CAPSAICIN; MENTHOL; LIDOCAINE HYDROCHLORIDE 25; .025; 10; 2.5 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 35356-544_2f46bb32-6f89-4fe4-a7da-4be6ba9c0fb2 35356-544 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20060906 ANDA ANDA077706 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC POLYETHYLENE GLYCOL 3350 17 g/17g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 35356-545_d2db70ba-7798-4ef3-925c-e56e747ff86c 35356-545 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20111117 NDA NDA022256 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MILNACIPRAN HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 35356-546_dfd77da2-6f3c-44f3-b70d-94189aa729ff 35356-546 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078783 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 35356-547_dfd77da2-6f3c-44f3-b70d-94189aa729ff 35356-547 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078783 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 35356-554_6faa24bc-3dee-4fb1-8b8f-6737c0547464 35356-554 HUMAN PRESCRIPTION DRUG Diclofenac Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20080501 ANDA ANDA077845 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-556_c8c73f4a-6e3f-425c-8806-0ed1c9c2e59a 35356-556 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 Lake Erie Medical DBA Quality Care Products LLC BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 35356-569_c43cb183-d3d2-48e1-b18a-200b8fa953bb 35356-569 HUMAN PRESCRIPTION DRUG TRANZGEL ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM GEL TRANSDERMAL 20111111 UNAPPROVED HOMEOPATHIC Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE 1; 1; 3; 3; 1; 1; 3; 1; 1; 1; 6; 4; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20181231 35356-570_f5b13d71-cb1f-470d-b0b9-36f0b711e566 35356-570 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20111206 NDA NDA013217 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 35356-573_9fc3163c-a307-48b9-9add-5c195dc24ecc 35356-573 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20111205 NDA NDA020859 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 35356-579_530976bb-8f1f-4354-b74d-d749a6dc038c 35356-579 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111206 ANDA ANDA091272 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 35356-580_5bc5e226-3241-425d-b063-e72c8a3bc75c 35356-580 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 35356-586_950adf2a-9bfc-4925-acc3-351ab0d6c764 35356-586 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Lake Erie Medical DBA Quality Care Products LLC Care Producst HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII E 20171231 35356-588_ff1bc45b-7117-44f3-bf97-5509c31cac2d 35356-588 HUMAN PRESCRIPTION DRUG Nuvigil Armodafinil TABLET ORAL 20090526 NDA NDA021875 Lake Erie Medical DBA Quality Care Products LLC ARMODAFINIL 250 mg/1 CIV N 20181231 35356-589_5270f354-e5f6-4e9b-824b-e3b4f92178a1 35356-589 HUMAN PRESCRIPTION DRUG Nuvigil armodafinil TABLET ORAL 20090601 NDA NDA021875 Lake Erie Medical DBA Quality Care Products LLC ARMODAFINIL 150 mg/1 CIV N 20181231 35356-592_2163f4b2-e6c4-4f63-b5df-8f41832fcd0e 35356-592 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19831021 ANDA ANDA088276 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 35356-593_af2e5bef-12cc-4964-8b85-8933b9ac634f 35356-593 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20110713 NDA NDA022304 Lake Erie Medical DBA Quality Care Products LLC TAPENTADOL HYDROCHLORIDE 75 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 35356-603_8b88104b-1fba-4a7b-8a46-34d4e056642e 35356-603 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20110113 ANDA ANDA076520 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 35356-604_6d2b3daa-6b68-4dcf-a566-7109474d2e3b 35356-604 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 35356-605_5fe0b1ac-b81d-4e06-a0f7-8702fdb619f0 35356-605 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20120326 NDA NDA021306 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUPRENORPHINE 10 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII E 20171231 35356-606_5fe0b1ac-b81d-4e06-a0f7-8702fdb619f0 35356-606 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20120326 NDA NDA021306 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUPRENORPHINE 20 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 35356-607_5fe0b1ac-b81d-4e06-a0f7-8702fdb619f0 35356-607 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20120326 NDA NDA021306 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUPRENORPHINE 5 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 35356-608_6957a248-d0e0-478a-81cc-6a615f0ab9a1 35356-608 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 12 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-609_6957a248-d0e0-478a-81cc-6a615f0ab9a1 35356-609 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-610_6957a248-d0e0-478a-81cc-6a615f0ab9a1 35356-610 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110314 NDA NDA021217 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-611_9156f5bf-be5f-4cd8-8a4c-bc8c204e666c 35356-611 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Lake Erie Medical DBA Quality Care Products LLC TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 35356-613_bad0d374-922a-4bc0-8fb0-96b895cae7cb 35356-613 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 35356-616_0e2de965-00aa-4624-b6bd-a060317c6122 35356-616 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20120306 ANDA ANDA075078 Lake Erie Medical & Surgical Supply DBA Qualtiy Care Products LLC ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 35356-619_3849029f-6ac2-4b34-99fc-a12de5374d1a 35356-619 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120309 ANDA ANDA078525 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 35356-621_313bfba3-51b5-41fe-80c2-2d2032977dc8 35356-621 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20111114 ANDA ANDA078154 Lake Eire Medical & Surgical Supply DBA Quality Care Products LLC LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 35356-622_30e15f1d-fdcd-4982-865c-c109da177f18 35356-622 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM DR PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 Lake Erie Medical DBA Quality Care Products LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 35356-623_430a7902-08d0-46ea-984d-674c9b8604fd 35356-623 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Lake Erie Medical DBA Quality Care Products LLC ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 35356-625_06553d77-f5fb-4fca-9448-eac6bb246b85 35356-625 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Lake Erie Medical DBA Quality Care Products LLC MILNACIPRAN HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 35356-627_2d2f31c6-98e7-4519-9fb6-ffb1107cbad4 35356-627 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081126 ANDA ANDA077715 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 35356-630_8906c928-5920-42d1-ba10-846363255112 35356-630 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET ORAL 20090514 ANDA ANDA078273 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-632_27f8b9db-e1a7-4669-a099-99e46cc4cbb4 35356-632 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20050128 ANDA ANDA076258 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 35356-634_38276e4e-d36c-49c4-888a-cd24f06723d3 35356-634 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH TRANSDERMAL 20150224 ANDA ANDA076258 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 87.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 35356-635_c7274269-63db-46ba-a397-13064c625fb5 35356-635 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20130109 ANDA ANDA076258 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-636_29b74b8b-762b-47ea-9373-90864e969d13 35356-636 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-637_29b74b8b-762b-47ea-9373-90864e969d13 35356-637 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-638_29b74b8b-762b-47ea-9373-90864e969d13 35356-638 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-639_29b74b8b-762b-47ea-9373-90864e969d13 35356-639 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-642_976b64c1-d064-4cb7-a824-fdfba6b94043 35356-642 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20111114 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN 18; 6; .015 mL/60mL; mL/60mL; mL/60mL N 20181231 35356-644_60f6bb1f-d15f-492a-8d1b-366ecc5f641d 35356-644 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20120403 ANDA ANDA075410 Lake Erie Medical DBA Quality Care Products LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 35356-647_0355cf40-12ec-427b-8a03-2657c4ec383d 35356-647 HUMAN PRESCRIPTION DRUG speedgel rx ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE GEL TRANSDERMAL 20111201 UNAPPROVED HOMEOPATHIC Lake Erie Medical DBA Quality Care Products LLC ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE; GINGER 1; 1; 3; 1; 1; 1; 3; 1; 1; 1; 1; 3; 3; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 35356-650_0689a8d5-705f-45ef-9aad-efbf910dd7e8 35356-650 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20120403 ANDA ANDA070791 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 35356-651_eb834045-6333-4d82-9b2a-1d221d1d89c0 35356-651 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073553 Lake Erie Medical DBA Quality Care Products LLC NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 35356-652_7060ce2d-7426-4b18-902a-4d2dee6e64e1 35356-652 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20120403 ANDA ANDA077050 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 35356-653_ff795d3c-1dfc-4c57-b40d-85c289b94798 35356-653 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20120402 ANDA ANDA071611 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 35356-655_f8518954-230a-4643-a671-c689319e7a84 35356-655 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20101231 ANDA ANDA079046 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-656_63e05976-e850-42a6-bfb1-d29a0580e5d4 35356-656 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 35356-658_a7ce6ebd-c0ef-40b5-ae45-03975d3598a8 35356-658 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 35356-659_1c1ab81f-0f11-4d10-8986-4e1a1b779bd9 35356-659 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20091123 ANDA ANDA076003 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 35356-660_4621244e-064d-4656-82ac-5c095ee8e8bc 35356-660 HUMAN PRESCRIPTION DRUG Tramadol hydrochloride and acetaminophen tramadol hydrochloride and acetaminophen TABLET ORAL 20050421 ANDA ANDA076475 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV E 20171231 35356-662_c48f74e3-5c0f-48ec-a437-1ac1f3820a66 35356-662 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20070206 ANDA ANDA076347 Lake Erie Medical DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 35356-663_29314e56-9120-4e7b-9bb1-a990c760a3a2 35356-663 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 Lake Erie Medical DBA Quality Care Products LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 35356-664_29314e56-9120-4e7b-9bb1-a990c760a3a2 35356-664 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 Lake Erie Medical DBA Quality Care Products LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 35356-666_fa439daa-07ef-417d-87ba-e1997402f4ce 35356-666 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Lake Erie Medical Quality Care Products LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 35356-668_f56ecdc6-eddb-4e16-9f3a-6e9615463229 35356-668 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 Lake Erie Medical DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 35356-669_f56ecdc6-eddb-4e16-9f3a-6e9615463229 35356-669 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 Lake Erie Medical DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 35356-670_598c9292-493f-4729-ab55-fb19906430bf 35356-670 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Lake Erie Medical DBA Quality Care Products LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 35356-672_d316add5-6ea9-4b80-9800-d1da6b68b6b9 35356-672 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20121105 ANDA ANDA040185 Lake Erie Medical DBA Quality Care Products LLC PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 35356-673_32261038-0fc2-4233-87c6-519c889e6ba2 35356-673 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19720522 ANDA ANDA080292 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PREDNISONE 5 mg/1 E 20171231 35356-674_bf5930a4-c03e-4d50-8d1d-f96fde8e03f2 35356-674 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 Lake Erie Medical & Surgial Supply DBA Quality Care Products LLC PREDNISONE 20 mg/1 E 20171231 35356-677_9f62f728-a97e-4570-b3e5-a6073dfe0d8f 35356-677 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA085162 Lake Erie Medical DBA Quality Care Products LLC PREDNISONE 10 mg/1 E 20171231 35356-678_f4d18222-10c9-4e21-8e53-0fe775a14f5d 35356-678 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20110726 ANDA ANDA078139 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 35356-679_4b7b0d18-4513-470d-9ef0-5d5f491e511c 35356-679 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 35356-680_a0668680-11fa-418c-a6cd-0aab058cd202 35356-680 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073554 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 35356-681_27a3bac0-06dd-4c02-9372-d67183cbe93f 35356-681 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 20120430 ANDA ANDA077025 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 35356-682_f76349ce-eba3-4c5b-9e7f-7aa89ccd1ffb 35356-682 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-683_0290fa5c-3417-413b-9363-08780907d68e 35356-683 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 35356-685_a55c8498-7a57-4110-8545-3b3a3522afe0 35356-685 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20020225 ANDA ANDA075280 Lake Erie Medical DBA Quality Care Products LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-686_e03b8121-b8c0-48b8-8873-1d3db68422a8 35356-686 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-687_7bc15015-75f0-47e9-90df-12efddb6d580 35356-687 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-688_476b7939-aa80-48ff-b7c6-511ecd34085e 35356-688 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Lake Erie Medical DBA Quality Care Products LLC MIRTAZAPINE 30 mg/1 E 20171231 35356-689_14563eaf-cadd-4b6a-9fe1-1383bce351fa 35356-689 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 35356-690_ccc3694b-3dde-4bbe-a426-f870049dfdfb 35356-690 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Lake Erie Medical DBA Quality Care Products LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 35356-692_75cb7f58-d6cc-4851-a261-8f201e7efeaf 35356-692 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20120214 ANDA ANDA077921 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 35356-693_75cb7f58-d6cc-4851-a261-8f201e7efeaf 35356-693 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20120214 ANDA ANDA077921 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 35356-694_26ea4d0e-6a7b-4a60-9996-c7a0484bf2ff 35356-694 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Lake Erie Medical DBA Quality Care Products LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 35356-696_11ac1811-0337-4c34-8127-618c473cde96 35356-696 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 Lake Erie Medical DBA Quality Care Products LLC KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 35356-697_955276b4-e3f3-4b98-922f-84ad8bed3397 35356-697 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 35356-698_28dbd035-be3e-4d3d-b318-563b1055c7db 35356-698 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-699_8f2513ce-55a1-4f07-a9ae-9aef4ddf79f3 35356-699 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Lake Erie Medical DBA Quality Care Products LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-701_b781ea50-9426-4673-96ce-660456beecff 35356-701 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 35356-702_c540b314-0cec-44c2-a803-8dd5bc0dd396 35356-702 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110801 ANDA ANDA040807 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 35356-704_2c43a247-d188-4f71-84ec-a4253082b09f 35356-704 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 35356-706_1fc9ccd8-08c3-4376-9643-c2d0b9435e7a 35356-706 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040400 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 35356-707_c62841eb-4e64-4bd3-807b-47ddae772709 35356-707 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 19980105 ANDA ANDA062452 Lake Erie Medical & Surgical Suppy DBA Quality Care Products LLC GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 35356-708_a68a987a-bbfd-4473-919d-6b5f87f21a05 35356-708 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 35356-709_b00102d2-c7ad-4915-a94d-a1ed3b57c231 35356-709 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 35356-710_e02124f2-fb73-40de-a42f-1216d3214e81 35356-710 HUMAN PRESCRIPTION DRUG Flurbiprofen flurbiprofen TABLET, FILM COATED ORAL 20110520 ANDA ANDA074358 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 35356-711_2e0d5790-7fdb-45c4-954d-5a616a4d6312 35356-711 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-712_78fda66a-2ef8-4215-994e-090545335452 35356-712 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 35356-713_b7012bb5-d4a7-4b2a-894b-5b0e390a88b0 35356-713 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19980811 ANDA ANDA075219 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-714_06430ad6-91c7-4cc9-b941-9a163129d896 35356-714 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-716_7c9e8449-fed2-471c-80e8-40faebe61bde 35356-716 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071135 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 35356-717_10c5a7f5-0eca-489e-9adf-4cd45cbdadca 35356-717 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20100423 ANDA ANDA077563 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 35356-718_d5292c86-3364-4b2c-9f7f-4584ce555c6c 35356-718 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 35356-719_ac7d0a73-f830-417f-8bf9-9299025fcfb9 35356-719 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 35356-720_d5292c86-3364-4b2c-9f7f-4584ce555c6c 35356-720 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 35356-721_c81ab486-d3ce-4663-8474-22ffc019a389 35356-721 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19871101 ANDA ANDA087499 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV E 20171231 35356-722_349a7943-1ba3-45e5-8388-ffac45912f54 35356-722 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960917 ANDA ANDA074569 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 35356-723_c3fff3c5-ec45-4c48-939e-4f94025ad4fe 35356-723 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 35356-724_7c9e8449-fed2-471c-80e8-40faebe61bde 35356-724 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071136 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 35356-725_06430ad6-91c7-4cc9-b941-9a163129d896 35356-725 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20101231 ANDA ANDA090066 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-727_3cbe3116-4328-4e77-9564-0e25f16949ca 35356-727 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 35356-728_696b54ae-459c-4d75-ad0d-3f7bb935a45e 35356-728 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Lake Erie Medical DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 35356-729_bd9aa124-c73f-485e-aa4d-b56795582514 35356-729 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Lake Erie Medical DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 35356-730_be42088b-67ff-4ad6-9577-c262c7d0a947 35356-730 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20120727 ANDA ANDA075786 Lake Erie Medical DBA Quality Care Products LLC FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 35356-732_dff97f6f-caaf-46f2-aef4-13e6c7fbfb64 35356-732 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 35356-736_23f27033-1d66-462a-93ea-b7dea07298fe 35356-736 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20101020 ANDA ANDA074584 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 35356-738_7b1454be-b5c3-4b47-99fc-40b7e5cc38ae 35356-738 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110130 ANDA ANDA077877 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 35356-739_4030fa9d-6eab-4449-8e4f-bbc703f02b4d 35356-739 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 35356-742_54da0e4c-8478-498b-b100-fc09b2719c26 35356-742 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 35356-743_54da0e4c-8478-498b-b100-fc09b2719c26 35356-743 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085967 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 35356-744_d68daef5-5cbb-4ddd-9256-448b53a7fc73 35356-744 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 35356-745_d2fd266d-e1e4-49fa-9c13-e6ffebf756ae 35356-745 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070427 ANDA ANDA077214 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 35356-746_e1c7f4f4-54cf-4921-9bae-69fac33ed085 35356-746 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20091201 ANDA ANDA077918 Lake Erie Medical DBA Quality Care Products LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 35356-747_1a8b6e3f-b7b0-4a00-b026-f769cb871c09 35356-747 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070108 ANDA ANDA071141 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 35356-748_7a48e38f-1e12-4f51-8cba-79594efa75fb 35356-748 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20101101 ANDA ANDA074198 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-749_db967d98-be9f-4e8d-b5ab-438b1c002fa8 35356-749 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 35356-751_c035ee75-b190-461b-bc9f-c5173b1b3b45 35356-751 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20071210 NDA NDA021977 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LISDEXAMFETAMINE DIMESYLATE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 35356-752_2e6097a4-f519-4437-851a-ab1c0fd20773 35356-752 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 35356-753_04172536-bc87-4ae1-920f-2908ae0d3904 35356-753 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19971126 ANDA ANDA040039 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 35356-754_a836d071-6ac3-45a5-af09-ba587e8c1f2c 35356-754 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20010726 ANDA ANDA075993 Lake Erie Medical DBA Quality Care Products LLC LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 35356-755_9c97e0ec-4a1a-4eaf-804a-16249918744e 35356-755 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA078050 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 35356-756_bc8626c9-549c-4461-b991-3b3bb3d40f2b 35356-756 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Lake Erie Medical DBA Quality Care Products LLC OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 35356-759_410c5db5-394f-4cbe-89bc-168f207a9d42 35356-759 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Lake Erie Medical DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 35356-760_c3a2891a-c632-4dc4-a1ee-fd768fa44410 35356-760 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110621 ANDA ANDA078424 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 750 mg/1 E 20171231 35356-761_1493001e-858a-46d3-98b6-3093adb8f460 35356-761 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20000526 ANDA ANDA040330 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-762_1493001e-858a-46d3-98b6-3093adb8f460 35356-762 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20030306 ANDA ANDA040434 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-763_a9130e10-50dc-4ef0-98fa-e26b7fc473c8 35356-763 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 19981222 ANDA ANDA040183 Lake Erie Medical DBA Quality Care Products LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 35356-765_cabc6d72-4616-44ac-8271-bbc3002c929b 35356-765 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20110829 ANDA ANDA078722 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 35356-766_faf9404e-588e-43d7-842c-6a7ea83f0ee1 35356-766 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120517 ANDA ANDA040846 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 35356-768_b830420b-77b5-4263-858c-6776a42450a2 35356-768 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 Lake Erie Medical DBA Quality Care Products LLC PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 35356-770_5ee2c0da-e618-4e77-b0ca-14bb0dfdbed4 35356-770 HUMAN PRESCRIPTION DRUG NUCYNTA ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Lake Erie Medical DBA Quality Care Products LLC TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 35356-771_cddfdb22-1fd2-4502-a35a-c75de4ab36c8 35356-771 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078434 Lake Erie Medical DBA Quality Care Products LLC KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 35356-772_0dd0ae26-00b1-4b9c-bb9f-5c506782665e 35356-772 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 35356-773_2d9ef975-4011-490b-b9b2-cb02247a10d3 35356-773 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101014 ANDA ANDA078243 Lake Erie Medical DBA Quality Care Products LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 35356-774_d124758d-1438-42d8-b844-ca87c9777b38 35356-774 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077995 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 35356-775_ea399fdb-2ce5-433d-917b-4e8911bfcf21 35356-775 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 35356-776_fc70ef31-60e7-4e25-b8c6-0b433ff3bde6 35356-776 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM diclofenac sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020109 ANDA ANDA075910 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 35356-777_981a9b27-8e8b-4fe6-8353-a1d8741caa7b 35356-777 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060927 ANDA ANDA077912 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 35356-778_981a9b27-8e8b-4fe6-8353-a1d8741caa7b 35356-778 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060927 ANDA ANDA077912 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 35356-779_2d9ef975-4011-490b-b9b2-cb02247a10d3 35356-779 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101014 ANDA ANDA078243 Lake Erie Medical DBA Quality Care Products LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 35356-780_b595ea16-8ce5-41e2-b1cb-b451ac20bc90 35356-780 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Lake Erie Medical DBA Quality Care Products LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 35356-781_ea399fdb-2ce5-433d-917b-4e8911bfcf21 35356-781 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 35356-782_5e78d3f8-4bc2-4a0c-b4dd-2d5f58a6b52b 35356-782 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 35356-783_daab10c4-1f80-4718-bb17-28e1868b5d79 35356-783 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 500 mg/1 E 20171231 35356-784_b0503934-5499-4de7-8cb6-388a48735577 35356-784 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20110906 ANDA ANDA090199 Lake Erie Medical DBA Quality Care Products LLC LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 35356-790_60207bcd-04aa-4c7f-864a-0a4513a01ad5 35356-790 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111212 ANDA ANDA201384 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 35356-791_aa649871-64ac-4710-8dfc-8876cce3cb42 35356-791 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 35356-792_9abe3702-cdf1-421c-b012-6168a00ece86 35356-792 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 35356-793_8d446e7c-8afa-4d90-834d-66628cd1b2d0 35356-793 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 Lake Erie Medical DBA Quality Care Products LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 35356-794_827fa543-03ae-4770-a65f-5e14be605c23 35356-794 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 Lake Erie Medical DBA Quality Care Products LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] E 20171231 35356-795_7ad923bd-4f60-4945-8420-b3f55e1aa798 35356-795 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 35356-796_7ad923bd-4f60-4945-8420-b3f55e1aa798 35356-796 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 35356-797_7ad923bd-4f60-4945-8420-b3f55e1aa798 35356-797 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 35356-798_c74b34d2-ec38-4c2b-8dd3-8ace7338dc94 35356-798 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 20020524 NDA AUTHORIZED GENERIC NDA050784 Lake Erie Medical DBA Quality Care Products LLC AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 35356-799_52d8b1b5-b4a6-4b0e-b691-fe7e870483ab 35356-799 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130508 ANDA ANDA078777 Lake Erie Medical DBA Quality Care Products LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 35356-800_52d8b1b5-b4a6-4b0e-b691-fe7e870483ab 35356-800 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130502 ANDA ANDA078777 Lake Erie Medical DBA Quality Care Products LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 35356-801_428059f2-0361-4b6b-8082-bf627053a9a0 35356-801 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120802 ANDA ANDA202677 Lake Erie Medical DBA Quality Care Product s LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-802_428059f2-0361-4b6b-8082-bf627053a9a0 35356-802 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120802 ANDA ANDA202677 Lake Erie Medical DBA Quality Care Product s LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-803_58a592a8-07f4-403f-8d2b-bbd7e104aa71 35356-803 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 35356-804_950adf2a-9bfc-4925-acc3-351ab0d6c764 35356-804 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Lake Erie Medical DBA Quality Care Products LLC Care Producst HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII E 20171231 35356-805_cb8a543a-87b5-4ae5-977a-d3c67a441105 35356-805 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 Lake Erie Medical DBA Quality Care Products LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 35356-806_9d33a2a1-bd98-453d-9f29-7808998a4c30 35356-806 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH, EXTENDED RELEASE TRANSDERMAL 20100825 ANDA ANDA079090 Lake Erie Medical DBA Quality Care Products LLC CLONIDINE .2 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 35356-807_71ba0dce-9ad2-4db0-930d-222b0ccdea5b 35356-807 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20100315 ANDA ANDA090510 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 35356-808_273bdac0-73b1-4fb4-a35b-38e1051ee3c4 35356-808 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Lake Erie Medical DBA Quality Care Products LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-809_59f7cb2e-8d42-4bbf-8f6d-ee7b79a42b87 35356-809 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Lake Erie Medical DBA Quality Care Products LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 35356-810_4da50452-c87c-470e-aae3-b234d1291e64 35356-810 HUMAN PRESCRIPTION DRUG NUCYNTA ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Lake Erie Medical DBA Quality Care Products LLC TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 35356-811_76b8332f-f336-4e78-a721-ba9fd2aceccb 35356-811 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20110114 ANDA ANDA075876 Lake Erie Medical DBA Quality Care Products LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 35356-812_def362fc-0061-4569-87a8-86cfa52aeaa6 35356-812 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071322 Lake Erie Medical DBA Quality Care Products LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 35356-813_ccc3694b-3dde-4bbe-a426-f870049dfdfb 35356-813 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Lake Erie Medical DBA Quality Care Products LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 35356-814_b3c1d1eb-2e14-4879-96c3-d46cb33f4183 35356-814 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA077471 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-815_b3c1d1eb-2e14-4879-96c3-d46cb33f4183 35356-815 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-816_b3c1d1eb-2e14-4879-96c3-d46cb33f4183 35356-816 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-817_5edd966d-633c-4db6-aecc-f2f5d8f519df 35356-817 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-818_95c5fe93-298c-49f0-8dd3-41ba39468806 35356-818 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 Lake Erie Medical DBA Quality Care Products LLC PREDNISONE 20 mg/1 N 20181231 35356-820_cb72fc3c-aa98-471b-a63c-700e06f5796b 35356-820 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-821_29314e56-9120-4e7b-9bb1-a990c760a3a2 35356-821 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120628 ANDA ANDA071457 Lake Erie Medical DBA Quality Care Products LLC TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 35356-822_95de3bec-31b0-440c-8e26-fb4006a54e72 35356-822 HUMAN OTC DRUG Promolaxin Docusate sodium TABLET ORAL 20110415 OTC MONOGRAPH NOT FINAL part334 Lake Erie Medical DBA Quality Care Products LLC DOCUSATE SODIUM 100 mg/1 N 20181231 35356-823_55a9cb2a-2c00-4e4a-adce-d48cc6ce1b23 35356-823 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20120822 ANDA ANDA040209 Lake Erie Medical DBA Quality Care Products LLC TRIFLUOPERAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 35356-825_cb72fc3c-aa98-471b-a63c-700e06f5796b 35356-825 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-826_1d4d5ad3-394b-4574-b4d3-f35eec6bebb5 35356-826 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 Lake Erie Medical DBA Quality Care Products LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-827_8fefe708-accf-4321-895c-29e859061ac5 35356-827 HUMAN PRESCRIPTION DRUG Erythromycin Base Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 Lake Erie Medical DBA Quality Care Products LLC ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 35356-828_44aeb86d-4ee6-4973-8f43-ba9f66ea9201 35356-828 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-829_44aeb86d-4ee6-4973-8f43-ba9f66ea9201 35356-829 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-830_44aeb86d-4ee6-4973-8f43-ba9f66ea9201 35356-830 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-831_5398edf9-dfb9-4af4-8196-2ea5cab3e9a7 35356-831 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical DBA Quality Care Products LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 5; .0375 g/100g; g/100g; g/100g E 20171231 35356-832_fe06b0b9-9e79-41bd-b9a1-ffe80d078b6a 35356-832 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET ORAL 20070102 ANDA ANDA077670 Lake Erie Medical DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 35356-833_01b156bf-e761-43e9-849e-036a3e2937ad 35356-833 HUMAN PRESCRIPTION DRUG morphine sulfate extended release morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-834_d6982b60-2b0c-4112-a167-c25c7e3f93f4 35356-834 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 Lake Erie Medical DBA Quality Care Products LLC METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-835_d6982b60-2b0c-4112-a167-c25c7e3f93f4 35356-835 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 Lake Erie Medical DBA Quality Care Products LLC METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-836_01b156bf-e761-43e9-849e-036a3e2937ad 35356-836 HUMAN PRESCRIPTION DRUG morphine sulfate extended release morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-837_01b156bf-e761-43e9-849e-036a3e2937ad 35356-837 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074769 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-838_01b156bf-e761-43e9-849e-036a3e2937ad 35356-838 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-839_1d6fb40c-3081-447c-8479-b3e544656cb6 35356-839 HUMAN PRESCRIPTION DRUG Oxycodone Hydchloride Oxycodone Hydchloride TABLET ORAL 20111220 ANDA ANDA091393 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-841_4f1ef3c0-a556-47f9-a708-e052a7c0871b 35356-841 HUMAN PRESCRIPTION DRUG morphine sulfate extended release morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074769 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35356-843_24049bea-a28e-4015-a4e3-f7a8c84abb42 35356-843 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 Lake Erie Medical DBA Quality Care Products LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 35356-844_bcb15169-915a-4a4a-b657-7c621c9646dd 35356-844 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20130305 ANDA ANDA077657 Lake Erie Medical DBA Quality Care Products LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 35356-845_a0f1b181-4d9a-4983-b3f5-7e8797f3e690 35356-845 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101013 ANDA ANDA078179 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 35356-846_4daf43f6-c0c0-40b7-a64c-d3fe821d86f2 35356-846 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 35356-847_10c5a7f5-0eca-489e-9adf-4cd45cbdadca 35356-847 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20060404 ANDA ANDA077563 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 35356-848_cb72fc3c-aa98-471b-a63c-700e06f5796b 35356-848 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-849_cb72fc3c-aa98-471b-a63c-700e06f5796b 35356-849 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA201655 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-850_0fe78b3f-0231-4a52-9bcc-07362ce2eb0b 35356-850 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20080711 ANDA ANDA076017 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 35356-851_c901630f-2fa4-4057-82cf-8e655835e378 35356-851 HUMAN OTC DRUG Cough Guaifenesin LIQUID ORAL 20091204 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC GUAIFENESIN 100 mg/5mL N 20181231 35356-852_23c40cff-640c-43d2-8f81-3230a234f457 35356-852 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA AUTHORIZED GENERIC NDA020699 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 35356-853_ee0f636e-0a98-4845-8798-20afd8a6d55a 35356-853 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070727 ANDA ANDA077851 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 35356-855_cd343223-770f-45e4-b6fc-099b0a44a989 35356-855 HUMAN OTC DRUG MEDROX MENTHOL, CAPSAICIN PATCH TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical DBA Quality Care Products LLC MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g N 20181231 35356-856_5074f6f3-d9bf-4c55-9454-e45d4e871318 35356-856 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Lake Erie Medical DBA Quality Care Products LLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 35356-857_b3fbf82b-b00f-41e4-b67c-e564c5943776 35356-857 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN 500 mg/1 N 20181231 35356-858_096c94fc-84ab-47c3-bd31-bbcbfda501ff 35356-858 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 35356-859_8cb1aedd-1174-49e4-ac42-d9f88b29d2e2 35356-859 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone atenolol and chlorthalidone TABLET ORAL 20130328 ANDA ANDA074203 Lake Erie Medical DBA Quality Care Products LLC ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 35356-860_c6b13215-f342-4c0e-99a3-18a43d1aba0c 35356-860 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 Lake Erie Medical DBA Quality Care Products LLC ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 35356-861_9f9ca4da-1a67-4eac-bc34-2df54b77479f 35356-861 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Lake Erie Medical DBA Quality Care Products LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 35356-863_ce3a3e93-7e63-4ba8-826e-3e09d6eee68d 35356-863 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Lake Erie Medical DBA Quality Care Products LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 35356-864_1a856d76-66ae-4923-a36a-221578253514 35356-864 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Lake Erie Medical DBA Quality Care Products LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 35356-865_e96b552d-9d1b-438f-9521-9cdb31a3936d 35356-865 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20000501 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 35356-866_6800704d-61ce-46e9-86c6-703b99b4ca3f 35356-866 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Lake Erie Medical DBA Quality Care Products LLC DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 35356-867_9cff1028-0c3b-4a40-a689-cb924bc59cc2 35356-867 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960308 NDA NDA020254 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 35356-868_9e771bb9-65ec-4cb1-adf9-b782704284e7 35356-868 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 Lake Erie Medical DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 35356-869_44fb0500-9c92-4460-85cb-357a5971c8fb 35356-869 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Lake Erie Medical DBA Quality Care Products LLC ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 35356-871_44fb0500-9c92-4460-85cb-357a5971c8fb 35356-871 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Lake Erie Medical DBA Quality Care Products LLC ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 35356-873_362485bb-0de7-4bc7-90e2-4bcc5e7b425a 35356-873 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 Lake Erie Medical DBA Quality Care Products LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 35356-875_f42876ef-0818-4812-9109-3a6de8471f2d 35356-875 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110301 ANDA ANDA074550 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 35356-876_05593a92-1af0-4574-bb0e-847a20081ba7 35356-876 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20071214 ANDA ANDA070719 Lake Erie Medical DBA Quality Care Products LLC INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 35356-877_d4f6e759-811f-4058-bd8b-203623e70e71 35356-877 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 250 mg/1 N 20181231 35356-879_5c7cac44-8e64-40cd-9357-fb27f3e33553 35356-879 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20070215 ANDA ANDA077321 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 35356-881_b60d432a-41dd-4fd9-ac71-1fcf31e06642 35356-881 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Lake Erie Medical DBA Quality Care Products LLC LORATADINE 10 mg/1 N 20181231 35356-883_3fddd2e9-f9cc-4547-b3cf-9c2444ea90a7 35356-883 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Lake Erie Medical DBA Quality Care Products LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 35356-884_3fddd2e9-f9cc-4547-b3cf-9c2444ea90a7 35356-884 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Lake Erie Medical DBA Quality Care Products LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 35356-885_acf8437b-25ee-45f9-bfdc-1bdac40911ce 35356-885 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 Lake Erie Medical DBA Quality Care Products LLC LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 35356-886_d78bfea5-014a-43c8-ad9d-a4961d908c7d 35356-886 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 35356-887_8b1b00c3-d7e5-457a-87f2-de90852450c7 35356-887 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Lake Erie Medical DBA Quality Care Products LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 35356-888_e5318a59-bb7d-41fe-813b-25f93ba1bc4a 35356-888 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 35356-889_a2561b14-d410-4e94-bf53-d61235ba7ead 35356-889 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 35356-890_5496967b-8e4f-4ed0-b94c-c757bb4da41b 35356-890 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070044 Lake Erie Medical DBA Quality Care Products LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 35356-891_947abf74-87d8-4a92-ab47-dd3306e390bc 35356-891 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE ORAL 20101013 ANDA ANDA075576 Lake Erie Medical DBA Quality Care Products LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 35356-892_a2caab72-4627-4463-a25d-7bfdd8a9f92a 35356-892 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Lake Erie Medical DBA Quality Care Products LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 35356-893_398cab9f-fe4c-4984-8f25-f4584754c06c 35356-893 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080624 ANDA ANDA077470 Lake Erie Medical DBA Quality Care Products LLC RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 35356-894_ecfeae02-a1b5-489d-8446-7a29da3a9a2a 35356-894 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130709 ANDA ANDA090548 Lake Erie Medical DBA Quality Care Products LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 35356-895_c7e6a876-8391-4c27-ad5f-0f7de0bc3d7c 35356-895 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070924 Lake Erie Medical DBA Quality Care Products LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 35356-896_ff87b26f-fd4c-46a0-a3f9-3b7704a4af01 35356-896 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Lake Erie Medical DBA Quality Care Products LLC GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 35356-897_88a4e935-dac5-48d6-bef2-7c823582d978 35356-897 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070507 ANDA ANDA076345 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 35356-898_e5318a59-bb7d-41fe-813b-25f93ba1bc4a 35356-898 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 35356-899_ea93ccfe-e1b2-435f-85ee-b7ed7c004fbd 35356-899 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 35356-900_8ad72871-99cc-4540-abd4-3978b3972a00 35356-900 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH FINAL part343 Lake Erie Medical DBA Quality Care Products LLC ASPIRIN 81 mg/1 N 20181231 35356-901_c793e424-4fc0-492e-9661-7fddea119d46 35356-901 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 20100604 ANDA ANDA040659 Lake Erie Medical DBA Quality Care Products LLC MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 35356-902_ecec56a6-9a40-4489-8ff4-e4709c0925d7 35356-902 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Lake Erie Medical DBA Quality Care Products LLC BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 35356-903_279a22b7-5aa0-44e1-acab-8731883815fe 35356-903 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20120921 ANDA ANDA077309 Lake Erie Medical DBA Quality Care Products LLC ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 35356-905_635d7332-0a5b-490e-9ec1-b05740efcf38 35356-905 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Lake Erie Medical DBA Quality Care Products LLC FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 35356-907_6800704d-61ce-46e9-86c6-703b99b4ca3f 35356-907 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951226 ANDA ANDA074185 Lake Erie Medical DBA Quality Care Products LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 35356-908_447cdffa-f20e-436c-b40c-2abf1af02806 35356-908 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Lake Erie Medical DBA Quality Care Products LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 35356-909_e1235056-dd31-4977-ad44-08ca332b2a01 35356-909 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20070511 ANDA ANDA076745 Lake Erie Medical DBA Quality Care Products LLC OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 35356-910_9f9ca4da-1a67-4eac-bc34-2df54b77479f 35356-910 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Lake Erie Medical DBA Quality Care Products LLC BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 35356-911_547e45bc-fafd-44c9-bc56-d2cfcf92bc17 35356-911 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Lake Erie Medical DBA Quality Care Products LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 35356-912_ecec56a6-9a40-4489-8ff4-e4709c0925d7 35356-912 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Lake Erie Medical DBA Quality Care Products LLC BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 35356-914_c793e424-4fc0-492e-9661-7fddea119d46 35356-914 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20100604 ANDA ANDA040659 Lake Erie Medical DBA Quality Care Products LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 35356-915_096c94fc-84ab-47c3-bd31-bbcbfda501ff 35356-915 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 35356-916_56cdf3a9-23ed-41e2-adb2-70aec9557c12 35356-916 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Lake Erie Medical DBA Quality Care Products LLC FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 35356-917_b41cd77b-a260-4f74-a39a-b3f29d52bcca 35356-917 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 35356-919_4e71b4f5-5545-440e-98de-365dfbfb353f 35356-919 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Lake Erie Medical DBA Quality Care Products LLC PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 35356-920_362485bb-0de7-4bc7-90e2-4bcc5e7b425a 35356-920 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 Lake Erie Medical DBA Quality Care Products LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 35356-921_4e71b4f5-5545-440e-98de-365dfbfb353f 35356-921 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Lake Erie Medical DBA Quality Care Products LLC PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 35356-922_d78bfea5-014a-43c8-ad9d-a4961d908c7d 35356-922 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 35356-923_d4f6e759-811f-4058-bd8b-203623e70e71 35356-923 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 500 mg/1 N 20181231 35356-924_901b0434-1459-42bb-af09-427cd8b68179 35356-924 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 35356-925_635d7332-0a5b-490e-9ec1-b05740efcf38 35356-925 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Lake Erie Medical DBA Quality Care Products LLC FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 35356-926_be42088b-67ff-4ad6-9577-c262c7d0a947 35356-926 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Lake Erie Medical DBA Quality Care Products LLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 35356-927_b536f80f-5fbd-41b6-a3b7-9df8a7e8cbf7 35356-927 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Lake Erie Medical DBA Quality Care Products LLC DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 35356-928_2fe367ab-4d42-4412-9cc1-9afb10ab4d43 35356-928 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20130502 ANDA ANDA075593 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 35356-929_ecfeae02-a1b5-489d-8446-7a29da3a9a2a 35356-929 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130709 ANDA ANDA090548 Lake Erie Medical DBA Quality Care Products LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 35356-930_34da6242-0058-4a6d-8a60-8cfe52b28c34 35356-930 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 Lake Erie Medical DBA Quality Care Products LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 35356-931_2d64cdce-e861-418a-bb75-b313b50b85bb 35356-931 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031107 ANDA ANDA076467 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 35356-932_88a4e935-dac5-48d6-bef2-7c823582d978 35356-932 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070614 ANDA ANDA076345 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 35356-933_901b0434-1459-42bb-af09-427cd8b68179 35356-933 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 35356-934_c3fd08d2-2fc3-446d-a97b-a41b37f5b10a 35356-934 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA077118 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 35356-935_91fdc9e5-e0ac-4ffb-aaec-6bfdd24d875f 35356-935 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Lake Erie Medical DBA Quality Care Products LLC SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 35356-936_693cc05b-6c39-4fb6-8bb8-ba8b83e36f19 35356-936 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine GEL TOPICAL 20130301 UNAPPROVED DRUG OTHER Lake Erie Medical DBA Quality Care Products LLC LIDOCAINE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 35356-937_8bb83d7a-4181-444e-9298-e32158529401 35356-937 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040778 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 35356-938_52492a63-ee93-4d95-aaaf-1d66b128b8aa 35356-938 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19840701 ANDA ANDA088496 Lake Erie Medical DBA Quality Care Products LLC HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 35356-939_76ea3e74-957b-456e-bee2-cad1be399692 35356-939 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040788 Lake Erie Medical DBA Quality Care Products LLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 35356-942_76ea3e74-957b-456e-bee2-cad1be399692 35356-942 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040787 Lake Erie Medical DBA Quality Care Products LLC HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 35356-943_7b5266df-711c-4c8f-80cb-03b34e8a905e 35356-943 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Lake Erie Medical DBA Quality Care Products LLC HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 35356-944_5b813664-0bc4-4635-821a-375e8a87c8ca 35356-944 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Lake Erie Medical DBA Quality Care Products LLC HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 35356-945_44fb0500-9c92-4460-85cb-357a5971c8fb 35356-945 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Lake Erie Medical DBA Quality Care Products LLC ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 35356-946_6ad6e639-7dbe-4001-9ee4-0d3d8b34d43f 35356-946 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Lake Erie Medical DBA Quality Care Products LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 35356-947_e9f59d65-3729-4202-8c0a-863f55f10c2e 35356-947 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Lake Erie Medical DBA Quality Care Products LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 35356-948_5c7cac44-8e64-40cd-9357-fb27f3e33553 35356-948 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20070215 ANDA ANDA077321 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 35356-949_3fddd2e9-f9cc-4547-b3cf-9c2444ea90a7 35356-949 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Lake Erie Medical DBA Quality Care Products LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 35356-950_c3ff129e-2a0a-4fdc-a00d-289b1ab96de0 35356-950 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20060824 ANDA ANDA077242 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 35356-951_eb12eb30-eb12-4418-9da2-861b3ee9309f 35356-951 HUMAN PRESCRIPTION DRUG Cilostazol cilostazol TABLET ORAL 20111018 ANDA ANDA077030 Lake Erie Medical DBA Quality Care Products LLC CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 35356-952_c45e8b73-59fe-4a29-80d3-2097319d8e5a 35356-952 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20120529 ANDA ANDA077899 Lake Erie Medical DBA Quality Care Products LLC NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 35356-954_7f068867-807a-4288-bdaf-bf7492569200 35356-954 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Lake Erie Medical DBA Quality Care Products LLC ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 35356-955_901b0434-1459-42bb-af09-427cd8b68179 35356-955 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 35356-957_3b0fd791-2bdc-44b5-ba21-b62da2ee0c68 35356-957 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Lake Erie Medical DBA Quality Care Products LLC PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 35356-958_498a9c09-edb3-4bb4-9f4f-235f00a14d14 35356-958 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 19900930 ANDA ANDA071655 Lake Erie Medical DBA Quality Care Products LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 35356-959_2c828a4d-a922-4b4e-b8f1-3fefd5e0328e 35356-959 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 35356-960_2794b368-9349-41a5-a2a7-0f788d22b607 35356-960 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 35356-961_50e56ba5-4e44-4b0f-bb15-f33b6bd3ab74 35356-961 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Lake Erie Medical DBA Quality Care Products LLC FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 35356-962_3ec36099-eb62-4167-918a-225886c82c06 35356-962 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 Lake Erie Medical DBA Quality Care Products LLC TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 35356-963_261b4ec9-0c42-4ecb-a32a-af7c8730ab37 35356-963 HUMAN OTC DRUG New Terocin Methyl Salicylate, Capsaicin, and Menthol LOTION TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical DBA Quality Care Products LLC METHYL SALICYLATE; CAPSAICIN; MENTHOL 25; .025; 10 g/100mL; g/100mL; g/100mL N 20181231 35356-964_b676952e-2ede-485b-9faf-ee13cdb138cd 35356-964 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Lake Erie Medical DBA Quality Care Products LLC SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] E 20171231 35356-965_2794b368-9349-41a5-a2a7-0f788d22b607 35356-965 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 35356-967_718f039f-33b6-4251-a873-c6bc26be88e5 35356-967 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20130211 ANDA ANDA203601 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 35356-968_718f039f-33b6-4251-a873-c6bc26be88e5 35356-968 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20130211 ANDA ANDA203601 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 35356-969_9f23c329-5f18-4adb-a856-172a70d42364 35356-969 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Lake Erie Medical DBA Quality Care Products LLC SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 35356-970_77d95bd2-5cb6-4873-a822-49e5509e3ae1 35356-970 HUMAN PRESCRIPTION DRUG Glipizide and Metformin HCl Glipizide and Metformin HCl TABLET, FILM COATED ORAL 20100629 ANDA ANDA078728 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 35356-971_6800704d-61ce-46e9-86c6-703b99b4ca3f 35356-971 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Lake Erie Medical DBA Quality Care Products LLC DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 35356-972_5b813664-0bc4-4635-821a-375e8a87c8ca 35356-972 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Lake Erie Medical DBA Quality Care Products LLC HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 35356-973_8c95641d-28cb-4716-9675-cb17ab43416c 35356-973 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 35356-974_6a7f64ce-e12d-4877-a633-d822874280d5 35356-974 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19970605 ANDA ANDA074821 Lake Erie Medical DBA Quality Care Products LLC TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 35356-975_5a5d1c68-33e1-4b45-a494-d647a1763dad 35356-975 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Lake Erie Medical DBA Quality Care Products LLC DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 35356-976_b12acecb-a486-44df-aee4-19a054c2502e 35356-976 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 35356-978_08ddec8d-f1a8-4b1d-ac1f-4ccb3eda3770 35356-978 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 35356-980_0fc7f64f-0bc9-4d4d-b23c-2a33d3ff0110 35356-980 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 19900930 ANDA ANDA062702 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 35356-981_3fca9693-10cd-45da-9c81-992f17a5f161 35356-981 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091568 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 35356-982_3fca9693-10cd-45da-9c81-992f17a5f161 35356-982 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091569 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 35356-983_67683692-d868-4218-897c-a9022d397978 35356-983 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 35356-984_9315f99a-4598-4a8b-b631-1aaea4152f3f 35356-984 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 35356-985_5822769c-2f5f-4fe6-9e7d-25b426db8288 35356-985 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19880225 ANDA ANDA062881 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 35356-986_0de01c94-51b8-4808-8247-925033848cb7 35356-986 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 35356-987_75719797-80a5-4a70-9059-4387fb5366e1 35356-987 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET ORAL 20000215 ANDA ANDA040327 Lake Erie Medical DBA Quality Care Products LLC ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 35356-988_ecec56a6-9a40-4489-8ff4-e4709c0925d7 35356-988 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Lake Erie Medical DBA Quality Care Products LLC BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 35356-989_f2b57029-f50b-4c67-b6b8-fc9bf31af16b 35356-989 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20050713 ANDA ANDA065228 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 35356-990_05917cba-1261-4700-a5ea-3bf4c7577556 35356-990 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20121024 ANDA ANDA077027 Lake Erie Medical DBA Quality Care Products LLC CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 35356-991_62633e27-4f50-44a5-880e-e377e51bf985 35356-991 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 Lake Erie Medical DBA Quality Care Products LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 35356-993_e2fe9292-f8a4-4dc2-b6ad-e3a429650cff 35356-993 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130613 ANDA ANDA200270 Lake Erie Medical DBA Quality Care Products LLC ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 35356-995_ad11d5fb-c1eb-4f00-a811-6e6baeb644cc 35356-995 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 35356-997_3b0fd791-2bdc-44b5-ba21-b62da2ee0c68 35356-997 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100706 ANDA ANDA090190 Lake Erie Medical DBA Quality Care Products LLC PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 35356-998_6f05f8e2-2fae-4434-ab18-f0f8a76a963d 35356-998 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride/Hydrochlorothiazide Quinapril Hydrochloride/Hydrochlorothiazide TABLET, FILM COATED ORAL 20070824 ANDA ANDA078450 Lake Erie Medical DBA Quality Care Products LLC QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 35356-999_34beb750-b5cd-4ac4-914c-81d6906fcb3d 35356-999 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Lake Erie Medical DBA Quality Care Products LLC FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 35378-0002_b46e9a34-442d-e4b4-6951-29d265e94951 35378-0002 HUMAN OTC DRUG Boost Remedy Water Adrenalinum, Aloe, Arsenicum alb., Baptisia, Berber. aqui., Berber. vulg., Bryonia, Chelidonium majus, Crotalus horridus, Digitalis, Ferrum metallicum, Glonoinum, Glycyrrhiza glabra, Hydrocotyle, Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. mur., Nux vom., Rhus toxicodendron, Ruta, Thuja occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum PELLET ORAL 20120701 UNAPPROVED HOMEOPATHIC Georgetown Health, LLC DBA EssentiaLife EPINEPHRINE; ALOE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 35378-0004_d4ce08ae-71e5-374d-0db4-59919e9bddb3 35378-0004 HUMAN OTC DRUG Calm Remedy Water Aconitum nap., Arg. nit., Aut. met., Baptisia, Bryonia, Chelidonium majus, Cimicifuga, Conium, Gelsemium, Ignatia, Kali carb., Lachesis, Lilum, Lycopodium, Nat. carb., Nat. mur., Phosphoricum ac., Phosphorus, Picricum ac., Plumb. met., Sepia, Staphysag., Stramonium, Thuja occ., Zinc. met., Chomomilla, Hypericum, Valeriana PELLET ORAL 20120701 UNAPPROVED HOMEOPATHIC Georgetown Health, LLC DBA EssentiaLife ACONITUM NAPELLUS; SILVER NITRATE; GOLD; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; BLACK COHOSH; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM BULB; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM CHLORIDE; PHOSPHORIC ACID; PHOSPHORUS; TRINITROPHENOL; LEAD; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 35378-0006_a1446b4f-37d5-ce89-d211-d7a4ac858ac0 35378-0006 HUMAN OTC DRUG Control Remedy Water Anacardium orientale, Antimon. crud., Arg. nit., Berber. vulg., Bryonia, Chelidonium majus, Digitalis, Graphites, Humulus, Iris Versicolor, SOLUTION ORAL 20120701 UNAPPROVED HOMEOPATHIC Georgetown Health, LLC DBA EssentiaLife SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWER; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 35378-0008_a0827118-9a02-24b0-4e70-9141b2f78d32 35378-0008 HUMAN OTC DRUG Cleanse Remedy Water Uricum acidum, Benzoicum acidum, Berber. vulg., Bryonia,Cantharis, Carduus benedictus,Ceanothus, Chelidonium majus, Chionanthus virginica,Cinchona, Dioscorea, Dolichos, Iris versicolor, Juniperus com, Nux vom., Ptelea, Taraxacum, Carduus mar., Cynara scolymus, Solidago, Taraxacum PELLET ORAL 20120701 UNAPPROVED HOMEOPATHIC Georgetown Health, LLC DBA EssentiaLife URIC ACID; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CNICUS BENEDICTUS; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA ROOT; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; JUNIPERUS COMMUNIS WHOLE 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 10 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 35378-0010_7cee29cf-2094-93b8-4113-2bc3fccf739b 35378-0010 HUMAN OTC DRUG Ease Remedy Water Aconitum nap., Antimon. tart., Arg. nit., Arnica, Bryona, Chamomilla, Chelidonium majus, Cimicifuga, Eupatorium perf., Hypericum, Nux vom., Rhus toxicodendron, Ruta, Sarcolacticum ac., Stramonium, Strychnium, Chamomilla, Phytolacca, Ruta, Symphytum PELLET ORAL 20120701 UNAPPROVED HOMEOPATHIC Georgetown Health, LLC DBA EssentiaLife ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; SILVER NITRATE; ARNICA MONTANA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; BLACK COHOSH; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYPERICUM PERFORATUM; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DATURA STRAMONIUM; STRYCHNINE; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 35378-0012_ef0aa2f2-26bc-f129-ed03-4e74dcbb2f38 35378-0012 HUMAN OTC DRUG Nobacco Remedy Water Arsenicum alb., Benzoicum acidum, Berber. vulg, Bryonia, Caladium seguinum, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Daphne indica, Ignatia, Iris versicolor, Lycopodium, Nicotinum, Nux vom., Rhus toxicodendron, Scutellaria lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana PELLET ORAL 20120701 UNAPPROVED HOMEOPATHIC Georgetown Health, LLC DBA EssentiaLife ARSENIC TRIOXIDE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DAPHNE ODORA BARK; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NICOTINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; TOBACCO LEAF; ECHINACEA, UNSPECIFIED; TARAXACUM OFFICINALE; VALERIAN; IRIS VERSICOLOR ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 15 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 35418-000_d9da0882-551e-4746-aba0-080e2ea60b16 35418-000 HUMAN OTC DRUG Naproxen Naproxen Sodium TABLET ORAL 20150331 ANDA ANDA090545 Zee Medical Inc NAPROXEN SODIUM 220 mg/1 N 20181231 35418-010_499d0748-5390-678c-e054-00144ff8d46c 35418-010 HUMAN OTC DRUG cherry throat relief lozenges benzocaine LOZENGE ORAL 20160414 OTC MONOGRAPH NOT FINAL part356 Zee Medical BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 35418-111_11e82391-4104-433d-b401-dd19c56bc33c 35418-111 HUMAN OTC DRUG Histenol Forte II Phenylephrine HCl, Acetaminophen, Guaifenesin TABLET ORAL 20120612 OTC MONOGRAPH FINAL part341 Zee Medical Inc PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN 5; 325; 100 mg/1; mg/1; mg/1 N 20181231 35418-119_6061da5a-3e25-48b6-bd8a-9ad5ab18fc65 35418-119 HUMAN OTC DRUG Cough Syrup DM Guaifenesin, Dextromethorpham HBr SYRUP ORAL 20120612 OTC MONOGRAPH FINAL part341 Zee Medical Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 35418-123_0250ecd3-28c2-45ad-aeba-690fd57a6be8 35418-123 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 20140116 ANDA ANDA074091 Zee Medical Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 35418-136_e9bfade6-443a-4372-ac40-9c9367fb43d3 35418-136 HUMAN OTC DRUG Dilotab II Acetaminophen Phenylephrine TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 35418-203_3a4035c3-164d-44cc-b228-87dac9b2e8fe 35418-203 HUMAN OTC DRUG Alcohol Prep pad Isopropyl Alcohol SWAB TOPICAL 20130115 OTC MONOGRAPH FINAL part344 ZEE MEDICAL ISOPROPYL ALCOHOL .7 mL/mL N 20181231 35418-210_9dea7120-07f3-4be1-b63d-827fef39377d 35418-210 HUMAN OTC DRUG Zee Unaspirin ES Acetaminophen TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ACETAMINOPHEN 500 mg/1 N 20181231 35418-232_61fd213f-4dd7-44c0-960d-4cb1d44f19a7 35418-232 HUMAN OTC DRUG Zee Aspirin Aspirin TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ASPIRIN 325 mg/1 N 20181231 35418-233_1ac45745-7dea-4265-882b-429b7a76221b 35418-233 HUMAN OTC DRUG Zee-Seltzer Antacid and Pain Reliever Aspirin, Citric Acid Monohydrate, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20060814 OTC MONOGRAPH FINAL part343 ZEE MEDICAL ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 E 20171231 35418-242_20129136-dd93-438c-a532-288e2948fd0e 35418-242 HUMAN OTC DRUG Zee Pain Aid Acetaminophen Salicylamide Aspirin TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ACETAMINOPHEN; ASPIRIN; SALICYLAMIDE 110; 162; 152 mg/1; mg/1; mg/1 N 20181231 35418-263_27aa100d-f80d-4410-868f-3527f67e506c 35418-263 HUMAN OTC DRUG Insect Sting Relief Wipes BENZOCAINE, ISOPROPYL ALCOHOL SWAB TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 ZEE MEDICAL BENZOCAINE; ISOPROPYL ALCOHOL 60; .6 mg/mL; mL/mL E 20171231 35418-310_fd0f349b-9899-49c3-b740-3f77c661ce36 35418-310 HUMAN OTC DRUG Trial Antacid Calcium Carbonate TABLET ORAL 20120612 OTC MONOGRAPH FINAL part331 Zee Medical Inc CALCIUM CARBONATE 420 mg/1 N 20181231 35418-334_87300767-d3fb-42fe-9b92-490a670ce3bd 35418-334 HUMAN OTC DRUG Congestaid II Phenylephrine Hydrochloride TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part341 Zee Medical Inc PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 N 20181231 35418-402_6016d1da-5c76-7acc-e053-2a91aa0a3e57 35418-402 HUMAN OTC DRUG Isopropyl Alcohol Alcohol SPRAY TOPICAL 20100708 OTC MONOGRAPH NOT FINAL part333E Zee Medical ALCOHOL 70 mL/100mL N 20181231 35418-560_88b72224-2aba-4d0b-9ac0-43f784485b27 35418-560 HUMAN OTC DRUG Pain Aid ESF Acetaminophen, Aspirin, Caffeine TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 35418-631_c54dcee0-8b21-4856-8391-d8ce5b4d0b8e 35418-631 HUMAN OTC DRUG Mouth Sore Medication benzocaine LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part356 Zee Medical BENZOCAINE 200 mg/g N 20181231 35418-710_f6ad4ae3-238c-4340-a5e1-3db7a2886533 35418-710 HUMAN OTC DRUG Pain Aid PMF Acetaminophen, Pamabrom TABLET ORAL 20120612 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc ACETAMINOPHEN; PAMABROM 500; 25 mg/1; mg/1 N 20181231 35418-750_259369b4-8c31-4579-ada7-71f44ca31961 35418-750 HUMAN OTC DRUG Ibutab Ibuprofen TABLET ORAL 20120612 ANDA ANDA079129 Zee Medical Inc IBUPROFEN 200 mg/1 N 20181231 35418-751_c1668618-0ae1-4f03-8d42-16c06c3266e1 35418-751 HUMAN OTC DRUG Zee Ibutab Ibuprofen TABLET ORAL 20150910 ANDA ANDA091239 Zee Medical Inc IBUPROFEN 200 mg/1 N 20181231 35418-801_0666a0e7-7c33-4230-b455-a06c897a28f5 35418-801 HUMAN OTC DRUG Pain Aid BRF Acetaminophen Magnesium Salicylate TABLET ORAL 20120819 OTC MONOGRAPH NOT FINAL part343 Zee Medical Inc MAGNESIUM SALICYLATE; ACETAMINOPHEN 250; 250 mg/1; mg/1 N 20181231 35484-924_47b59658-f4bb-45cb-e054-00144ff88e88 35484-924 HUMAN OTC DRUG Cramp911 Magnesium sulfate, Copper sulfate LOTION TOPICAL 20080901 UNAPPROVED HOMEOPATHIC DelCorean, LLC BASIC COPPER SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM .05; .05 [hp_X]/mL; [hp_X]/mL N 20181231 35484-924_481f5af0-deb5-5bd3-e054-00144ff8d46c 35484-924 HUMAN OTC DRUG Cramp911 Magnesium Sulfate, Copper Sulfate LOTION TOPICAL 20080901 UNAPPROVED HOMEOPATHIC DelCorean, LLC MAGNESIUM SULFATE, UNSPECIFIED; BASIC COPPER SULFATE .05; .05 [hp_X]/mL; [hp_X]/mL N 20181231 35567-0001_c81173eb-2820-46ab-8745-313fda80ef7b 35567-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990101 UNAPPROVED MEDICAL GAS Uptown Pharmacy of Kingsman OXYGEN 99 L/100L E 20171231 35573-006_be8820fb-884f-4b67-9632-e8c0b36d8cd0 35573-006 HUMAN OTC DRUG RelCof-C Codeine Phosphate and Guaifenesin LIQUID ORAL 20090902 OTC MONOGRAPH FINAL part341 Burel Pharmaceuticals, LLC CODEINE PHOSPHATE; GUAIFENESIN 6.3; 100 mg/5mL; mg/5mL N 20181231 35573-103_28ccc65c-7e07-4315-ae4f-d46bec774366 35573-103 HUMAN PRESCRIPTION DRUG RELNATE DHA OMEGA-3 FATTY ACIDS, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, CHOLECALCIFEROL, ASCORBIC ACID, ALPHA-TOCOPHEROL, CUPRIC SULFATE ANHYDROUS, ZINC OXIDE, IRO CAPSULE, LIQUID FILLED ORAL 20110515 UNAPPROVED DRUG OTHER Burel Pharmaceuticals, LLC OMEGA-3 FATTY ACIDS; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; CHOLECALCIFEROL; ASCORBIC ACID; ALPHA-TOCOPHEROL; CUPRIC SULFATE ANHYDROUS; ZINC OXIDE; IRON; MAGNESIUM 200; 3; 3; 20; 15; 1; 400; 100; 30; 1; 20; 28; 30 mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 35573-200_28ccc65c-7e07-4315-ae4f-d46bec774366 35573-200 HUMAN PRESCRIPTION DRUG RELNATE DHA OMEGA-3 FATTY ACIDS, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, CHOLECALCIFEROL, ASCORBIC ACID, ALPHA-TOCOPHEROL, CUPRIC SULFATE ANHYDROUS, ZINC OXIDE, IRO CAPSULE, LIQUID FILLED ORAL 20110515 UNAPPROVED DRUG OTHER Burel Pharmaceuticals, LLC OMEGA-3 FATTY ACIDS; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; CHOLECALCIFEROL; ASCORBIC ACID; ALPHA-TOCOPHEROL; CUPRIC SULFATE ANHYDROUS; ZINC OXIDE; IRON; MAGNESIUM 200; 3; 3; 20; 15; 1; 400; 100; 30; 1; 20; 28; 30 mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; [iU]/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 35573-305_398bad3b-2006-4cea-87ee-6552c1ac2d7d 35573-305 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride phenazopyridine hydrochloride TABLET ORAL 20160222 UNAPPROVED DRUG OTHER Burel Pharmaceuticals, Inc PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 35573-306_398bad3b-2006-4cea-87ee-6552c1ac2d7d 35573-306 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride phenazopyridine hydrochloride TABLET ORAL 20160222 UNAPPROVED DRUG OTHER Burel Pharmaceuticals, Inc PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 35573-315_3b411422-fe28-4de6-a811-8aa8b57317d9 35573-315 HUMAN PRESCRIPTION DRUG INDIOMIN MB hyoscyamine sulfate, methenamine, methylene blue, and sodium phosphate, monobasic, monohydrate CAPSULE ORAL 20150928 UNAPPROVED DRUG OTHER Burel Pharmaceuticals, Inc HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .12; 120; 10; 40.8 mg/1; mg/1; mg/1; mg/1 Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 35573-323_9dce9e5c-3010-4a54-9067-3018eb230e45 35573-323 HUMAN OTC DRUG RelCof IR Guaifenesin, Phenylephrine HCl TABLET ORAL 20160322 OTC MONOGRAPH FINAL part341 BUREL PHARMACEUTICALS, INC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 380; 10 mg/1; mg/1 N 20181231 35573-324_340a2860-a2af-4991-a973-e095cf5ed4ba 35573-324 HUMAN OTC DRUG Relhist BP Brompheniramine Maleate, Phenylephrine HCl TABLET ORAL 20160322 OTC MONOGRAPH FINAL part341 BUREL PHARMACEUTICALS, INC BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 35617-392_5549a1c2-a26b-4367-a399-9e354c7ee0c0 35617-392 HUMAN OTC DRUG Povidone-Iodine Prep Pad Povidone-Iodine SWAB PERCUTANEOUS 20100517 OTC MONOGRAPH FINAL part333C NANTONG STRIP MEDICAL SUPPLY CO.,LTD. POVIDONE-IODINE 10 mL/1 E 20171231 35617-393_806658e8-00f1-4184-96cf-695a09bb882b 35617-393 HUMAN OTC DRUG Benzalkonium Chloride Antiseptic benzalkonium chloride SWAB TOPICAL 20100520 OTC MONOGRAPH FINAL part348 NANTONG STRIP MEDICAL SUPPLY CO.,LTD. BENZALKONIUM CHLORIDE .004 mL/1 E 20171231 35617-394_926a20c4-4740-4ba7-9aab-9425721b2477 35617-394 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20100524 OTC MONOGRAPH FINAL part348 NANTONG STRIP MEDICAL SUPPLY CO.,LTD. ISOPROPYL ALCOHOL .7 mL/1 E 20171231 35617-395_25bb85a9-3735-41ce-b8d1-d161f0d39eaf 35617-395 HUMAN OTC DRUG Sting Relief Benzocaine,Alcohol SWAB TOPICAL 20100524 OTC MONOGRAPH FINAL part348 NANTONG STRIP MEDICAL SUPPLY CO.,LTD. BENZOCAINE; ALCOHOL .06; .6 mL/1; mL/1 E 20171231 35617-396_d7222229-7952-432b-9a8d-936825469ae7 35617-396 HUMAN OTC DRUG Alcohol ISOPROPYL ALCOHOL SWAB TOPICAL 20110620 OTC MONOGRAPH FINAL part344 NANTONG STRIP MEDICAL SUPPLY CO.,LTD. ISOPROPYL ALCOHOL .7 mL/1 E 20171231 35617-397_9bea2c38-9eac-4b4d-b28f-cebf3de14d88 35617-397 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SWAB PERCUTANEOUS 20110620 OTC MONOGRAPH NOT FINAL part333E NANTONG STRIP MEDICAL SUPPLY CO.,LTD. POVIDONE-IODINE .1 mL/1 E 20171231 35617-399_ff5a9591-a0a6-4094-8368-c6c2b565c481 35617-399 HUMAN OTC DRUG Cleansing Wipe / Tube SODIUM CHLORIDE SWAB TOPICAL 20120812 OTC MONOGRAPH FINAL part349 NANTONG STRIP MEDICAL SUPPLY CO.,LTD. SODIUM CHLORIDE .9 g/100mL E 20171231 35781-0194_9135b37f-d8f4-44ae-a7b3-677a1c83ee84 35781-0194 HUMAN PRESCRIPTION DRUG TRANZGEL ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM GEL TRANSDERMAL 20100701 UNAPPROVED HOMEOPATHIC Gensco Laboratories, LLC ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE 1; 1; 3; 3; 1; 1; 3; 1; 1; 1; 6; 4; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20181231 35781-0210_16334ed4-e2b9-4d6d-9bda-c8f995c82ec2 35781-0210 HUMAN PRESCRIPTION DRUG SPEEDGEL RX ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE GEL TRANSDERMAL 20111201 UNAPPROVED HOMEOPATHIC Gensco Laboratories, LLC ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE; GINGER 1; 1; 3; 1; 1; 1; 3; 1; 1; 1; 1; 3; 3; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 35781-0230_ab5093da-fe6e-437f-94bd-d233a3683967 35781-0230 HUMAN OTC DRUG INFLAM-X Aconitum Napellus, Arnica Montana, Belladonna, Bellis Perennis, Calendula Officinallis, Chamomilla, Echinacea Angustifolia, Echinacea Purpurea, Hamamellis Virginiana, Hypericum Perforatum, Millefolium, Symphytum Officinale, Zingiber Officinale GEL TOPICAL 20100617 UNAPPROVED HOMEOPATHIC Gensco Laboratories, LLC ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWER; CHAMOMILE; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; COMFREY ROOT; GINGER 3; 3; 4; 1; 1; 1; 1; 1; 1; 1; 1; 4; 1 [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL; [hp_X]/6mL N 20181231 35781-0300_d71d8d63-a984-4bcd-9e78-428fd8f8705c 35781-0300 HUMAN PRESCRIPTION DRUG Lido Rx Lidocaine GEL TOPICAL 20130301 UNAPPROVED DRUG OTHER Gensco Laboratories, LLC LIDOCAINE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 35781-0400_dc2c63c7-af59-4d36-b656-e5e72f5f0769 35781-0400 HUMAN PRESCRIPTION DRUG COLCIGEL COLCHICINUM 4x GEL TRANSDERMAL 20150501 UNAPPROVED HOMEOPATHIC Gensco Laboratories, LLC COLCHICINE 4 [hp_X]/15mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20181231 35813-375_cd1063e9-2254-48b2-97ad-2bc18fabda5a 35813-375 HUMAN OTC DRUG DIAPEDIC FOOT AND LEG TREATMENT MENTHOL CREAM TOPICAL 20110831 OTC MONOGRAPH NOT FINAL part348 ANASTASIA MARIE LABORATORIES, INC. MENTHOL 1.8 g/100g N 20181231 35831-001_77924bb9-7a25-4b24-ab4c-28ecbfd8df44 35831-001 HUMAN OTC DRUG Master HG Aralia quonquefolia 3X, Arnica montana 3X, Carduus marianus 3X, Damiana 3X, Galium aparine 3X, Hamamelis virginiana 3X, Hepar suis 6X, Natrum muriaticum 200C, Phosphoricum acidum 3X, Pituitarum posterium 30X, Taraxacum officinale 200C, Thuja occidentalis 200C LIQUID SUBLINGUAL 20130416 UNAPPROVED HOMEOPATHIC Great American Products, Inc AMERICAN GINSENG; ARNICA MONTANA; SILYBUM MARIANUM SEED; TURNERA DIFFUSA LEAFY TWIG; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; SODIUM CHLORIDE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 3; 3; 6; 200; 3; 30; 3; 200 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL E 20171231 35896-001_904cff57-9047-4ed7-84c8-fadd4d0fff8b 35896-001 HUMAN OTC DRUG Super HG aralia quinquefolia, arnica montana, carduus marianus, damiana, galium aparine, hamamelis virginiana, hepar suis, natrum muriaticum, phosphoricum acidum, pituitarum posterium, taraxacum officinale, thuja occidentalis LIQUID SUBLINGUAL 20130515 UNAPPROVED HOMEOPATHIC Physician's Choice, Inc. AMERICAN GINSENG; ARNICA MONTANA; SILYBUM MARIANUM SEED; TURNERA DIFFUSA LEAFY TWIG; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; SODIUM CHLORIDE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 3; 3; 6; 200; 3; 30; 3; 200 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL E 20171231 36000-001_19039f5a-cd06-46c8-92fa-f8f4c1ca43bb 36000-001 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE INJECTION, SOLUTION INTRAVENOUS 20081120 ANDA ANDA078084 Baxter Healthcare Corporation METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20191231 36000-002_4707882f-ce90-43de-b909-598f5d2cd8da 36000-002 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20100609 20191231 ANDA ANDA077909 Baxter Healthcare Corporation FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 36000-003_4707882f-ce90-43de-b909-598f5d2cd8da 36000-003 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20100609 20191231 ANDA ANDA077909 Baxter Healthcare Corporation FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 36000-006_4707882f-ce90-43de-b909-598f5d2cd8da 36000-006 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20100609 20191231 ANDA ANDA077988 Baxter Healthcare Corporation FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 36000-007_4707882f-ce90-43de-b909-598f5d2cd8da 36000-007 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20100609 20191231 ANDA ANDA077988 Baxter Healthcare Corporation FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 36000-008_b2d8afca-7a89-4080-82e2-363c20e2078a 36000-008 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20080804 ANDA ANDA078024 Baxter Healthcare Corporation CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 36000-009_b2d8afca-7a89-4080-82e2-363c20e2078a 36000-009 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20080804 ANDA ANDA078024 Baxter Healthcare Corporation CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 36000-010_b2d8afca-7a89-4080-82e2-363c20e2078a 36000-010 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090917 ANDA ANDA078062 Baxter Healthcare Corporation CIPROFLOXACIN 10 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 36000-011_b2d8afca-7a89-4080-82e2-363c20e2078a 36000-011 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090917 ANDA ANDA078062 Baxter Healthcare Corporation CIPROFLOXACIN 10 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 36000-012_b5cdd0e5-e6f8-4f24-8979-a1cc2e0af2fe 36000-012 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130313 ANDA ANDA078287 Baxter Healthcare Corporation ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 36000-013_b5cdd0e5-e6f8-4f24-8979-a1cc2e0af2fe 36000-013 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130313 ANDA ANDA078288 Baxter Healthcare Corporation ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 36000-014_8eef2a1d-20ea-45d2-84ef-f9e64ec84796 36000-014 HUMAN PRESCRIPTION DRUG Ondansetron hydrochloride and dextrose ondansetron hydrochloride and dextrose INJECTION, SOLUTION INTRAVENOUS 20090414 ANDA ANDA078308 Claris Lifesciences, Inc ONDANSETRON HYDROCHLORIDE 32 mg/50mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 36000-028_19039f5a-cd06-46c8-92fa-f8f4c1ca43bb 36000-028 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE INJECTION, SOLUTION INTRAVENOUS 20081120 ANDA ANDA078084 Baxter Healthcare Corporation METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20191231 36000-029_b2d8afca-7a89-4080-82e2-363c20e2078a 36000-029 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20121023 ANDA ANDA078024 Baxter Healthcare Corporation CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 36000-030_b2d8afca-7a89-4080-82e2-363c20e2078a 36000-030 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin INJECTION, SOLUTION INTRAVENOUS 20121023 ANDA ANDA078024 Baxter Healthcare Corporation CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 36000-033_75b81e08-a728-438b-afb1-e553687464fb 36000-033 HUMAN PRESCRIPTION DRUG Metoprolol metoprolol tartrate INJECTION INTRAVENOUS 20120925 ANDA ANDA078950 Baxter Healthcare Corporation METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 36000-045_7a2bea1e-65b4-40e5-9733-d704013a2704 36000-045 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin INJECTION, SOLUTION INTRAVENOUS 20130701 ANDA ANDA091436 Baxter Healthcare Corporation LEVOFLOXACIN 25 mg/mL N 20191231 36000-046_7a2bea1e-65b4-40e5-9733-d704013a2704 36000-046 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin INJECTION, SOLUTION INTRAVENOUS 20130701 ANDA ANDA091397 Baxter Healthcare Corporation LEVOFLOXACIN 5 mg/mL N 20191231 36000-047_7a2bea1e-65b4-40e5-9733-d704013a2704 36000-047 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin INJECTION, SOLUTION INTRAVENOUS 20130701 ANDA ANDA091397 Baxter Healthcare Corporation LEVOFLOXACIN 5 mg/mL N 20191231 36000-048_7a2bea1e-65b4-40e5-9733-d704013a2704 36000-048 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin INJECTION, SOLUTION INTRAVENOUS 20130701 ANDA ANDA091397 Baxter Healthcare Corporation LEVOFLOXACIN 5 mg/mL N 20191231 36000-063_97584f82-b35c-44b8-8668-b965b2a28339 36000-063 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Baxter Healthcare Corporation FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 36000-064_97584f82-b35c-44b8-8668-b965b2a28339 36000-064 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Baxter Healthcare Corporation FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 36000-065_97584f82-b35c-44b8-8668-b965b2a28339 36000-065 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Baxter Healthcare Corporation FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 36000-070_0bfd0e69-f2ec-4ce6-a97d-e0812c65c27b 36000-070 HUMAN PRESCRIPTION DRUG Ampicillin ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100425 ANDA ANDA090354 Claris Lifesciences, Inc. AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 36000-071_0bfd0e69-f2ec-4ce6-a97d-e0812c65c27b 36000-071 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100425 ANDA ANDA090354 Claris Lifesciences, Inc. AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 36000-072_0bfd0e69-f2ec-4ce6-a97d-e0812c65c27b 36000-072 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100425 ANDA ANDA090354 Claris Lifesciences, Inc. AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 36000-073_0bfd0e69-f2ec-4ce6-a97d-e0812c65c27b 36000-073 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100425 ANDA ANDA090354 Claris Lifesciences, Inc. AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 36000-092_f26e33e4-cc84-4919-b5c1-bd867498a509 36000-092 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INTRASPINAL 20160808 ANDA ANDA207266 Baxter Healthcare Corporation BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 36000-094_96960f4b-4cca-496a-9b09-60b9cbb72d69 36000-094 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151214 ANDA ANDA201406 Claris Life Sciences Inc. AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] E 20171231 36000-095_96960f4b-4cca-496a-9b09-60b9cbb72d69 36000-095 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151214 ANDA ANDA201406 Claris Life Sciences Inc. AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] E 20171231 36000-148_cd40ca90-3e17-4935-adf2-c9ac32f5ce41 36000-148 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20171001 ANDA ANDA076755 Baxter Healthcare Corporation FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20191231 36000-149_cd40ca90-3e17-4935-adf2-c9ac32f5ce41 36000-149 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20171001 ANDA ANDA076755 Baxter Healthcare Corporation FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20191231 36000-162_60905fad-e586-427f-93dd-64b8f7c063e0 36000-162 HUMAN PRESCRIPTION DRUG Norepinephrine bitartrate Norepinephrine bitartrate INJECTION INTRAVENOUS 20120401 ANDA ANDA040859 Baxter Healthcare Corporation NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 36000-175_a56b5261-a7af-490a-865c-aadd615bf677 36000-175 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION INTRAMUSCULAR; INTRAVENOUS 20120201 ANDA ANDA090560 Claris Lifesciences, Inc. NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 36000-176_a56b5261-a7af-490a-865c-aadd615bf677 36000-176 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION INTRAMUSCULAR; INTRAVENOUS 20120201 ANDA ANDA090560 Claris Lifesciences, Inc. NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 36000-242_2a8283f8-2c7f-4f6f-8df5-02a4975413fa 36000-242 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION INTRAMUSCULAR; INTRAVENOUS 20160715 ANDA ANDA206965 Baxter Healthcare Corporation TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 36000-244_2a8283f8-2c7f-4f6f-8df5-02a4975413fa 36000-244 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION INTRAMUSCULAR; INTRAVENOUS 20160715 ANDA ANDA206965 Baxter Healthcare Corporation TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 36000-261_4707882f-ce90-43de-b909-598f5d2cd8da 36000-261 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20100609 20191231 ANDA ANDA077909 Baxter Healthcare Corporation FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 36000-282_97584f82-b35c-44b8-8668-b965b2a28339 36000-282 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Baxter Healthcare Corporation FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 36000-283_97584f82-b35c-44b8-8668-b965b2a28339 36000-283 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Baxter Healthcare Corporation FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 36000-284_97584f82-b35c-44b8-8668-b965b2a28339 36000-284 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Baxter Healthcare Corporation FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 36000-287_4707882f-ce90-43de-b909-598f5d2cd8da 36000-287 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20150219 20191231 ANDA ANDA077909 Baxter Healthcare Corporation FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 36000-288_4707882f-ce90-43de-b909-598f5d2cd8da 36000-288 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole INJECTION INTRAVENOUS 20150224 20191231 ANDA ANDA077909 Baxter Healthcare Corporation FLUCONAZOLE 2 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 36006-001_929f1937-2c6b-4186-b1ad-8e38bbcff159 36006-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Medicor Homecare, Inc. OXYGEN 99 L/100L E 20171231 36769-001_f7fb4376-49a4-441e-aca6-dd5942b0b37c 36769-001 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20110204 OTC MONOGRAPH NOT FINAL part333A Büttner-Frank GmbH Arzt- und Krankenhausbedarf - Krankenpflege und Einmalartikel ISOPROPYL ALCOHOL .7 mg/mg E 20171231 36769-002_a44b062a-2f5f-4652-99f0-2e53bd538bf1 36769-002 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part333A Büttner-Frank GmbH Arzt- und Krankenhausbedarf - Krankenpflege und Einmalartikel ISOPROPYL ALCOHOL .7 mg/mg E 20171231 36800-000_da6584ce-2326-4985-9c67-acb9a1a9d287 36800-000 HUMAN OTC DRUG Flu Relief Childrens Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, Phenylephrine HCI SUSPENSION ORAL 20150731 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 36800-001_479cfd25-d261-4c2b-abb0-6257a8d98c33 36800-001 HUMAN OTC DRUG Mouth Rinse sodium fluoride MOUTHWASH ORAL 20101230 OTC MONOGRAPH FINAL part355 Topco associates LLC SODIUM FLUORIDE .1 mg/mL N 20181231 36800-002_bcfe101d-9046-4545-af4d-4abf43fce654 36800-002 HUMAN OTC DRUG topcare enema Dibasic sodium phosphate, Monobasic sodium phosphate ENEMA RECTAL 20091105 OTC MONOGRAPH NOT FINAL part334 Topco Associates LLC SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL N 20181231 36800-003_ea625319-1839-49e1-9d89-aa668bbbaa49 36800-003 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 36800-004_c9db95c3-cbcf-4af9-a2e8-402ae9c8fa7c 36800-004 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE RINSE ORAL 20040408 OTC MONOGRAPH FINAL part355 Topco Associates LLC SODIUM FLUORIDE .05 kg/100L N 20181231 36800-005_102cfcaf-9a26-4e1e-a186-5f4a65129777 36800-005 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20120103 OTC MONOGRAPH FINAL part358B Topco Associates LLC SALICYLIC ACID .17 mg/9.8mL N 20181231 36800-006_5a033e3e-6e6d-4061-8ebb-2d024a3b4ae7 36800-006 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20120103 OTC MONOGRAPH FINAL part333C Topco Associates LLC TOLNAFTATE 1.5 g/150g N 20181231 36800-007_b104cb32-bfad-4d6f-842b-759e1f5470a3 36800-007 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM 100 mg/1 N 20181231 36800-009_f250f852-ac6a-4ef2-92f4-3835627610a3 36800-009 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20091014 OTC MONOGRAPH FINAL part333D Topco Associates LLC SALICYLIC ACID 19.8 mg/g N 20181231 36800-011_153d1839-0e8a-4c4c-a452-04303022e6df 36800-011 HUMAN OTC DRUG First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20040729 OTC MONOGRAPH NOT FINAL part333E Topco Associates LLC POVIDONE-IODINE 10 mg/mL N 20181231 36800-012_79ba91a8-5f68-4861-87bf-fbf11adf4bd6 36800-012 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20120103 OTC MONOGRAPH FINAL part333C Topco Associates LLC TOLNAFTATE 1.3 g/130g N 20181231 36800-015_3093e541-8362-44dd-810e-5cdec58da940 36800-015 HUMAN OTC DRUG Emerald Mint Health Cetylpyridinium Chloride MOUTHWASH ORAL 20130919 OTC MONOGRAPH NOT FINAL part356 TopCo Associates LLC CETYLPYRIDINIUM CHLORIDE .07 g/mL N 20181231 36800-016_6645e88b-ac26-4efb-9dac-79bdff0bf053 36800-016 HUMAN OTC DRUG TopCare Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Topco Associates LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; mg/g N 20181231 36800-017_14e4eb70-9280-49a8-9f5f-d584063db806 36800-017 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20140127 OTC MONOGRAPH FINAL part347 Topco Associates LLC LANOLIN; PETROLATUM 133; 459 mg/g; mg/g N 20181231 36800-018_6be8f701-114a-402b-a9a1-67d2daf764b4 36800-018 HUMAN OTC DRUG TopCare Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC HYDROCORTISONE 1 g/100g N 20181231 36800-019_6b7513bd-9bb9-460d-8e2b-2d4030d4aa5d 36800-019 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20120103 OTC MONOGRAPH FINAL part358F Topco Associates LLC SALICYLIC ACID 40 mg/41 N 20181231 36800-020_286d932a-9b00-4242-b642-52e10b655f89 36800-020 HUMAN OTC DRUG Diaper Rash Zinc oxide PASTE TOPICAL 19890415 OTC MONOGRAPH FINAL part347 TopCare Associates, LLC ZINC OXIDE 532 mg/g N 20181231 36800-021_85da4d4d-9e80-495b-b333-7bbd5c795449 36800-021 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20120103 OTC MONOGRAPH FINAL part358F Topco Associates LLC SALICYLIC ACID 40 mg/91 N 20181231 36800-022_e081ce00-3562-418b-86b1-04e03d300ea5 36800-022 HUMAN OTC DRUG TopCare Heartburn Relief Cimetidine TABLET ORAL 20000222 ANDA ANDA075285 Topco Associates LLC CIMETIDINE 200 mg/1 N 20181231 36800-023_b71e6962-546f-4e29-91a6-86d9070f4ef7 36800-023 HUMAN OTC DRUG Tolnaftate Foot Odor Control Spray AEROSOL, SPRAY TOPICAL 20120105 OTC MONOGRAPH FINAL part333C Topco Associates LLC TOLNAFTATE 1.13 g/113g N 20181231 36800-024_ee7776e2-a970-49b4-a18c-2ab8a67be2ec 36800-024 HUMAN OTC DRUG Tolnaftate Jock Itch Powder AEROSOL, SPRAY TOPICAL 20120103 OTC MONOGRAPH FINAL part333C Topco Associates LLC TOLNAFTATE 1.3 g/130g N 20181231 36800-025_de6ff12d-efa2-4b9a-8a2b-9dcadef9826b 36800-025 HUMAN OTC DRUG TOPCARE 2 IN 1 DANDRUFF DRY SCALP PYRITHIONE ZINC LIQUID TOPICAL 20140728 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL N 20181231 36800-025_eef1754e-081e-4efe-91a1-f2c2905e349a 36800-025 HUMAN OTC DRUG TopCare 2 in 1 Dandruff Dry Scalp Pyrithione Zinc LIQUID TOPICAL 20170515 OTC MONOGRAPH FINAL part358H TopCo Associates LLC PYRITHIONE ZINC 10 mg/mL N 20181231 36800-026_d302f008-99ca-4fdb-8c6a-478df02c248b 36800-026 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20120103 OTC MONOGRAPH FINAL part333C Topco Associates LLC MICONAZOLE NITRATE 2.6 g/130g N 20181231 36800-027_1633dda0-b969-4495-8e5b-578bf89e3584 36800-027 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH FINAL part343 TOP CARE (Topco Associates LLC) ASPIRIN 81 mg/1 N 20181231 36800-028_55a10b9f-8810-7bb0-1fb0-416e3ae85377 36800-028 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160915 ANDA ANDA208150 Topco Associates LLC FLUTICASONE PROPIONATE 50 ug/1 N 20181231 36800-029_1f8450a8-cdaf-4b4b-a3a6-aac78eadcc5f 36800-029 HUMAN OTC DRUG TopCare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050420 ANDA ANDA076775 Topco Associates LLC NICOTINE 2 mg/1 N 20181231 36800-030_0b78c0e9-c312-4ac1-b53e-f051b7b09e4b 36800-030 HUMAN OTC DRUG Aspirin enteric safety coated Aspirin TABLET ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 TOP CARE (Topco Associates LLC) ASPIRIN 81 mg/1 N 20181231 36800-031_6503964e-5d5d-4195-9357-1ac6e30eb3aa 36800-031 HUMAN OTC DRUG Lidocaine Burn Relief AEROSOL, SPRAY TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC LIDOCAINE .64 g/127g N 20181231 36800-032_43783a99-aca9-4bf3-a5e5-923a2727352e 36800-032 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20160825 ANDA ANDA074612 Topco Associates LLC NICOTINE 7 mg/24h N 20191231 36800-034_43783a99-aca9-4bf3-a5e5-923a2727352e 36800-034 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20160825 ANDA ANDA074612 Topco Associates LLC NICOTINE 14 mg/24h N 20191231 36800-035_0b6021fc-3483-409a-b082-cc102cc75e0d 36800-035 HUMAN OTC DRUG Mucus Relief Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20151130 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 36800-036_f5227139-7ec4-40a2-bca4-5684f2939c1e 36800-036 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 650; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 36800-037_ef1357f5-d672-4a8e-bc1d-ae3c7e5af1bc 36800-037 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 36800-038_43783a99-aca9-4bf3-a5e5-923a2727352e 36800-038 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20160825 ANDA ANDA074612 Topco Associates LLC NICOTINE 21 mg/24h N 20191231 36800-039_d789524e-19e6-4f66-afb3-1427abb631c5 36800-039 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20141031 OTC MONOGRAPH FINAL part347 TOP CARE (Topco Associates LLC) WITCH HAZEL 842 mg/mL N 20181231 36800-040_101a9f91-50dc-47ef-be58-509c562d0d37 36800-040 HUMAN OTC DRUG TopCare Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER TOPCO ASSOCIATES LLC PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 36800-042_9ef393b1-8484-4321-9ad7-c9be0a7bf15e 36800-042 HUMAN OTC DRUG Pain Relief Rub Camphor,Menthol, methyl salicylate CREAM TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC MENTHOL; MENTHYL SALICYLATE, (+/-)-; CAMPHOR (NATURAL) 10; 30; 4 g/100g; g/100g; g/100g E 20171231 36800-043_cf6b6625-ccab-46f8-a0c7-641d112ff6c5 36800-043 HUMAN OTC DRUG Salicylic Acid Wart Remover Gel GEL TOPICAL 20141007 OTC MONOGRAPH FINAL part358B Topco Associates LLC SALICYLIC ACID .17 g/7g N 20181231 36800-044_ba091aa7-9542-4255-9f33-3ac3e99741b4 36800-044 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM 100 mg/1 N 20181231 36800-045_4ccfb9cd-2ba5-4d14-bf8a-760a18736e72 36800-045 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part335 TOP CARE (Topco Associates LLC) BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 36800-048_6dc37700-e250-4768-ab71-ad02e78cff8e 36800-048 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20150531 ANDA ANDA078682 TOP CARE (Topco Associates LLC) IBUPROFEN 200 mg/1 N 20181231 36800-049_be171b74-4800-4574-85c8-dd0848f6941b 36800-049 HUMAN OTC DRUG Athletes Foot Butenafine Hydrochloride CREAM TOPICAL 20171117 ANDA ANDA205181 TOPCO ASSOCIATES LLC BUTENAFINE HYDROCHLORIDE 10 mg/g N 20181231 36800-050_26949321-8113-4b1a-a3a3-e222ef7cd023 36800-050 HUMAN OTC DRUG Topcare Ibuprofen PM diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20090218 ANDA ANDA079113 Topco Associates LLC DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 36800-051_1189d6d6-b691-4bc4-81fb-a43e00dd6106 36800-051 HUMAN OTC DRUG TopCare Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC HYDROCORTISONE 1 g/100g N 20181231 36800-052_fc414094-dab4-410e-9cab-486986e783d4 36800-052 HUMAN OTC DRUG TopCare Tolnaftate Antifungal Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Topco Associates LLC TOLNAFTATE 10 mg/g N 20181231 36800-054_d8e5384f-842a-4ae7-881b-f0626cf72f66 36800-054 HUMAN OTC DRUG topcare 12 hour decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000425 ANDA ANDA075153 Topco Associates LLC PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20191231 36800-055_91be786d-0ec4-4c10-9e3d-30752b9808da 36800-055 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140630 ANDA ANDA091353 TOP CARE (Topco Associates LLC) NAPROXEN SODIUM 220 mg/1 N 20181231 36800-056_022e1153-de1f-4949-a6b6-f168ea7482c8 36800-056 HUMAN OTC DRUG TopCare Triple Antibiotic Plus Pain Relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Topco Associates LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 36800-057_ef3501a2-d3a0-478f-b0de-15b146e47a2d 36800-057 HUMAN OTC DRUG Topcare Infants Ibuprofen ibuprofen SUSPENSION ORAL 20020122 ANDA ANDA075217 Topco Associates LLC IBUPROFEN 50 mg/1.25mL N 20181231 36800-058_df56c898-37d7-4f1b-843a-75e7d84226d7 36800-058 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20141031 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM 250 mg/1 N 20181231 36800-059_f5759319-9f4c-4538-bd78-d9e282cfc194 36800-059 HUMAN OTC DRUG TopCare Hydrocortisone 1% with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC HYDROCORTISONE 1 g/100g N 20181231 36800-061_76884134-ae46-4b5c-93c6-bc880607cd6b 36800-061 HUMAN OTC DRUG Nighttime Allergy Relief Extra Strength Diphenhydramine HCl TABLET ORAL 20140731 OTC MONOGRAPH FINAL part338 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 36800-062_9cf4438c-40a4-4cba-8d4d-f8f6095f38e8 36800-062 HUMAN OTC DRUG TopCare Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 Topco Associates LLC CLOTRIMAZOLE 2 g/100g N 20181231 36800-063_7f14451c-40eb-4283-9eb4-5fb95937ef8a 36800-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19910915 OTC MONOGRAPH FINAL part347 Topco Associates LLC FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 36800-065_9955d365-4ab6-4b7a-8850-c724754f7aab 36800-065 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20141031 OTC MONOGRAPH NOT FINAL part356 TOP CARE (Topco Associates LLC) PHENOL 1.5 g/100mL N 20181231 36800-066_2705f5b5-d8ac-45c9-a50b-e52ff45dfb17 36800-066 HUMAN OTC DRUG ANTIBACTERIAL MANDARIN TRICLOSAN SOLUTION TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES L LLC TRICLOSAN .6 mL/100mL N 20181231 36800-067_c9121daa-b506-49c5-a4b7-7a483fc5017c 36800-067 HUMAN OTC DRUG Antibacterial Foaming Cucumber Melon Triclosan LIQUID TOPICAL 20110902 OTC MONOGRAPH NOT FINAL part333E Topco Associates llc TRICLOSAN .6 mL/100mL N 20181231 36800-068_b2533d95-95ae-4f5d-bb85-5b94c0c41440 36800-068 HUMAN OTC DRUG TOPCARE MEDICATED CLEANSING PADS WITCH HAZEL SOLUTION TOPICAL 20120301 OTC MONOGRAPH FINAL part346 TOPCO ASSOCIATES LLC WITCH HAZEL .5 mL/mL N 20181231 36800-069_e05ff177-5de9-4503-8119-867421dd49f7 36800-069 HUMAN OTC DRUG Pure petroleum White Petrolatum JELLY TOPICAL 19910815 OTC MONOGRAPH FINAL part347 Topco Associates LLC PETROLATUM 1 g/g N 20181231 36800-070_fb2be2e9-360f-4142-8043-d95039ce6e9d 36800-070 HUMAN OTC DRUG TopCare Miconazole 3 Yeast Infection Relief Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Topco Associates LLC MICONAZOLE NITRATE 40 mg/g N 20181231 36800-072_169fd50d-ba44-4cb3-bbf4-2ba01591582a 36800-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 19950707 OTC MONOGRAPH NOT FINAL part348 TOPCO ASSOCIATES, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 36800-074_6eb42a2b-e69f-4d4b-b2c1-41e288ce2b40 36800-074 HUMAN OTC DRUG Topcare Ibuprofen Ibuprofen TABLET, COATED ORAL 20060410 ANDA ANDA077349 Topco Associates LLC IBUPROFEN 200 mg/1 N 20181231 36800-076_7f195ebc-22d2-40db-9392-52c8b5da33d2 36800-076 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111102 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN .6 mL/100mL N 20181231 36800-077_63327d98-f7a9-4ff8-bfd9-3b538d984ee6 36800-077 HUMAN OTC DRUG Isopropyl Alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A TOP CARE (Topco Associates LLC) ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 36800-078_1a98fb58-3959-46cd-a99b-9078b371858b 36800-078 HUMAN OTC DRUG TOPCARE VITAMIN E ETHYL ALCOHOL LIQUID TOPICAL 20131226 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 700 mg/mL N 20181231 36800-078_cef6ec06-fee6-4708-9f48-46ea005ee776 36800-078 HUMAN OTC DRUG TOPCARE VITAMIN E ETHYL ALCOHOL LIQUID TOPICAL 20131226 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 700 mg/mL N 20181231 36800-079_215322c1-75b0-48ed-9bab-416a66d0bdf6 36800-079 HUMAN OTC DRUG TOPCARE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131118 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 700 mg/mL N 20181231 36800-079_2f625f76-dac6-4450-88bc-f10abc542996 36800-079 HUMAN OTC DRUG TOPCARE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20130731 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 700 mg/mL N 20181231 36800-080_14c28769-cffa-4189-8e68-5b53f76f2f41 36800-080 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Topco Associates LLC TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 36800-081_21e8f69a-5e8c-42e4-a4f8-897bf436ff28 36800-081 HUMAN OTC DRUG topcare miconazole 3 combination pack Miconazole nitrate KIT 20000510 ANDA ANDA075329 Topco Associates LLC N 20181231 36800-082_2c5a1694-d6e9-4679-b421-61eaad5403a4 36800-082 HUMAN OTC DRUG topcare dual action complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20160229 ANDA ANDA077355 Topco Associates LLC FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 36800-084_00e47e60-46b4-4382-877c-7ac3ce1652d7 36800-084 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 36800-085_09cb64e9-37db-4581-aeca-fe733c4a90dd 36800-085 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 36800-089_b948c617-0f26-4692-b537-b83c98f0dccb 36800-089 HUMAN OTC DRUG TopCare Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Topco Associates LLC BACITRACIN ZINC 500 [iU]/g N 20181231 36800-091_eddabaaa-cf68-4037-9348-2a5ed396bf47 36800-091 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 19871215 OTC MONOGRAPH NOT FINAL part348 Topco Associates MENTHOL 1.5 mg/g N 20181231 36800-092_b6906c5c-5554-4a10-9985-1877660a68f1 36800-092 HUMAN OTC DRUG TopCare Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Topco Associates LLC LORATADINE 5 mg/5mL N 20181231 36800-094_4cf91b5f-22b6-4dd2-91a3-516b74c489fa 36800-094 HUMAN OTC DRUG TopCare Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20050912 OTC MONOGRAPH FINAL part341 Topco Associates LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 36800-096_40ee3b9e-9eb9-4770-bf42-b16309166bc2 36800-096 HUMAN OTC DRUG topcare flu and severe cold and cough daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120117 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 36800-098_cb1ccd53-264f-46bf-b02a-c8b090c7bd77 36800-098 HUMAN OTC DRUG Daytime Sinus Relief Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120914 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 36800-099_cc4257fd-c315-41d9-b709-f32da2ce7f23 36800-099 HUMAN OTC DRUG TopCare Hydrocortisone Intensive Healing Formula Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC HYDROCORTISONE 1 g/100g N 20181231 36800-100_507785ab-856a-4d7c-aa11-54cfd5f0effd 36800-100 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20130901 OTC MONOGRAPH FINAL part347 Topco Associates LLC ZINC OXIDE 20 g/100g E 20171231 36800-101_bb73a8ea-e4c8-4fe8-b714-803e923dfc61 36800-101 HUMAN OTC DRUG Nitetime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120901 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 36800-102_201062ce-440b-4524-8c64-383eed28e185 36800-102 HUMAN OTC DRUG DayTime Nitetime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine HCl KIT 20130115 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) N 20181231 36800-103_4d5b170d-57a4-4bbc-9110-90c12c88a06b 36800-103 HUMAN OTC DRUG TOPCARE MAXIMUM STRENGTH URINARY PAIN RELIEF PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20110201 UNAPPROVED DRUG OTHER TOPCO ASSOCIATES LLC PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 36800-106_5c005d43-bd25-4d47-b501-390d233899d9 36800-106 HUMAN OTC DRUG TopCare Complete Lice Treatment Piperonyl butoxide, pyrethrum extract KIT 20160616 OTC MONOGRAPH FINAL part358G Topco Associates LLC N 20181231 36800-107_befb1f5e-9b2a-4ba3-8dc8-a7196d96ca33 36800-107 HUMAN OTC DRUG topcare allergy relief Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20150107 ANDA ANDA076447 Topco Associates LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 36800-108_6732a02b-1eff-4275-ac82-36c5f0b1d5d4 36800-108 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND BERRY BLAST BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140727 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-108_f7604112-8e0b-487e-a9bd-a832de0b642a 36800-108 HUMAN OTC DRUG TopCare Antibacterial Foaming Hand Berry Blast Benzalkonium Chloride LIQUID TOPICAL 20170529 OTC MONOGRAPH NOT FINAL part333E TopCo Associates LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-109_43a41735-f752-4e70-ad06-b89d019bb5e7 36800-109 HUMAN OTC DRUG TopCare Antibacterial Foaming Hand Fresh Pear Benzalkonium Chloride LIQUID TOPICAL 20170428 OTC MONOGRAPH NOT FINAL part333E TopCo Associates LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-109_8527a69b-2da5-4b48-9b70-12bdbacd1322 36800-109 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-109_ce725323-49ca-4791-bb24-a31c375dc61b 36800-109 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-111_3242e10d-dae8-44fc-a9d0-148571b85b27 36800-111 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM 100 mg/1 N 20181231 36800-112_66084e09-2674-4185-9211-91f4d6743b2f 36800-112 HUMAN OTC DRUG TopCare Antibacterial Foaming Hand Cucumber Melon Benzalkonium Chloride LIQUID TOPICAL 20170427 OTC MONOGRAPH NOT FINAL part333E TopCo Associates LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-112_b96473fe-346e-40ad-9767-8c600914fc8e 36800-112 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND CUCUMBER MELON BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-113_e2c53b94-21db-6506-e864-e50b47156f97 36800-113 HUMAN OTC DRUG Budesonide Budesonide SPRAY, METERED NASAL 20160831 ANDA ANDA078949 Topco Associates LLC BUDESONIDE 32 ug/1 N 20181231 36800-114_88eed11e-ad99-4a3b-9435-39af40e943ec 36800-114 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-114_a97a97b4-c365-41d9-b322-0d29ca822b05 36800-114 HUMAN OTC DRUG TopCare Antibacterial Foaming Hand Fresh Water Benzalkonium Chloride LIQUID TOPICAL 20170613 OTC MONOGRAPH NOT FINAL part333E TopCo Associates LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-117_a4ca302c-026a-4b9d-8ba6-bc7e748773f7 36800-117 HUMAN OTC DRUG Topcare Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120910 ANDA ANDA202319 Topco Associates LLC LANSOPRAZOLE 15 mg/1 N 20181231 36800-120_ba6c3654-00e6-4313-bb9f-ab54d3232ef0 36800-120 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20130531 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) BISACODYL 5 mg/1 N 20181231 36800-121_dee7d36d-797b-4bcd-bedd-df9e567810ca 36800-121 HUMAN OTC DRUG TopCare Omeprazole delayed release Omeprazole CAPSULE, DELAYED RELEASE ORAL 20160202 NDA NDA022032 Topco Associates LLC OMEPRAZOLE 20 mg/1 N 20181231 36800-124_32d005d1-6924-49a1-b493-785a78f181a3 36800-124 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND COMPLETE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-124_da83e973-ad28-467f-b322-0003cd2e3183 36800-124 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING HAND COMPLETE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-124_fb1df434-8280-4699-a2f0-731b0a681b0d 36800-124 HUMAN OTC DRUG TopCare Antibacterial Foaming Hand Complete Benzalkonium Chloride LIQUID TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333E TopCo Associates LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-125_b73eea97-df63-476a-95c0-62c71b8ceb95 36800-125 HUMAN OTC DRUG Gas Relief ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20101004 OTC MONOGRAPH FINAL part332 TOP CARE (Topco Associates LLC) DIMETHICONE 180 mg/1 E 20171231 36800-128_aba10c5a-0329-41c0-ac35-fff406b3b19d 36800-128 HUMAN OTC DRUG TopCare Childrens Allergy Relief Nasal 24 Hour Fluticasone Propionate SPRAY, METERED NASAL 20160728 ANDA ANDA207957 Topco Associates LLC FLUTICASONE PROPIONATE 50 ug/1 N 20191231 36800-131_49a5e75d-fb4e-4307-91f0-96c7e32c5b62 36800-131 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Topco Associates LLC LORATADINE 5 mg/5mL N 20181231 36800-136_58a1d1c0-401f-40bc-a78a-41c03d96d603 36800-136 HUMAN OTC DRUG Stomach Relief Pepto Bismol Cherry SUSPENSION ORAL 20131108 OTC MONOGRAPH FINAL part335 TOP CARE (Topco Associates LLC) BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 36800-138_14053c83-1b9b-499f-ba95-16a35fcdb4db 36800-138 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20130531 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) SENNOSIDES 25 mg/1 N 20181231 36800-140_d76c4de0-933f-403a-b8f1-feb24d5ea39c 36800-140 HUMAN OTC DRUG Topcare All Day Pain Relief Naproxen sodium TABLET, FILM COATED ORAL 20071203 ANDA ANDA074661 Topco Associates LLC NAPROXEN SODIUM 220 mg/1 N 20181231 36800-141_88722f84-dac8-4130-93b3-9e0dc1cc5acc 36800-141 HUMAN OTC DRUG TopCare Acid Reducer Famotidine TABLET ORAL 20090911 ANDA ANDA075400 Topco Associates LLC FAMOTIDINE 10 mg/1 N 20181231 36800-143_47896dc0-13f7-4a76-96ef-33180fb0e29b 36800-143 HUMAN OTC DRUG topcare nite time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140202 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 36800-144_f4032969-7499-472d-84ff-8ebc500db1b7 36800-144 HUMAN OTC DRUG TopCare Mucus D Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20160801 ANDA ANDA091071 Topco Associates LLC GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 36800-145_121015de-10fe-41f0-8ae5-7c870ed694ee 36800-145 HUMAN OTC DRUG Topcare Mucus Relief cold and sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130628 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 36800-147_658c39a6-6a08-4058-b56d-9c94f3691bb4 36800-147 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140331 OTC MONOGRAPH NOT FINAL part343 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 36800-150_d0b7f0f1-901c-4b0b-a256-f0046bc53542 36800-150 HUMAN OTC DRUG STOOL SOFTENER Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM 250 mg/1 N 20181231 36800-151_326fc19b-98e2-4781-b2fb-d9aa9a044f05 36800-151 HUMAN OTC DRUG topcare sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20101103 OTC MONOGRAPH FINAL part338 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 36800-152_6a1ecc77-3dfd-48e3-9d2b-2e759ae1abd6 36800-152 HUMAN OTC DRUG TopCare Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Top Care MENTHOL 750 mg/1 N 20181231 36800-153_ab651690-7a94-448d-82fe-8e32e865f79b 36800-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19971215 OTC MONOGRAPH FINAL part358H Topco Associates LLC PYRITHIONE ZINC 1 kg/100L N 20181231 36800-154_d18e3f38-acd3-4d41-aa7e-8fe35a9dce29 36800-154 HUMAN OTC DRUG Flu Relief Therapy Night Time Acetaminophen, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20100128 20180330 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 36800-155_601a71b3-14ba-8159-e053-2a91aa0ae131 36800-155 HUMAN OTC DRUG Top Care Medicated Menthol PATCH TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part348 Top Care MENTHOL 750 mg/1 N 20181231 36800-158_c3ca0e98-b0bd-4401-a0a1-bf416025dfbd 36800-158 HUMAN OTC DRUG topcare congestion relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20150106 ANDA ANDA203200 Topco Associates LLC IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20181231 36800-160_6d25afe1-f69d-4b6d-917f-abf1cacbd506 36800-160 HUMAN OTC DRUG ANTIBACTERIAL FOR THE KITCHEN TRICLOSAN SOLUTION TOPICAL 20110803 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN .46 mL/100mL N 20181231 36800-161_0d0a4489-c6bb-4960-8a57-e18a12af12e3 36800-161 HUMAN OTC DRUG Topcare pain and fever Acetaminophen SUSPENSION ORAL 20110826 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL N 20181231 36800-162_7a3b30f5-2dee-443b-a218-ec644e1443a4 36800-162 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20130315 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 36800-163_a04a5af5-3839-4ad3-b9d9-71c1a9ca407d 36800-163 HUMAN OTC DRUG Foaming Antibacterial Pear Triclosan SOAP TOPICAL 20100726 OTC MONOGRAPH NOT FINAL part333E Topco Associates LLC TRICLOSAN .46 mL/100mL N 20181231 36800-165_8ec65988-ee1a-45f6-b3ac-f614d2305222 36800-165 HUMAN OTC DRUG Ibuprofen PM Ibuprofen and Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20110922 ANDA ANDA090397 TOP CARE (Topco Associates LLC) IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE 200; 25 mg/1; mg/1 N 20181231 36800-166_c5041c38-1fe4-47fd-b964-dc7bad5fa43d 36800-166 HUMAN OTC DRUG topcare childrens ibuprofen Ibuprofen SUSPENSION ORAL 20020730 ANDA ANDA074937 Topco Associates LLC IBUPROFEN 100 mg/5mL N 20181231 36800-168_d1a2d469-9a1e-4ec9-8a79-205b9215da49 36800-168 HUMAN OTC DRUG TopCare Antibacterial Foaming Triclosan SOAP TOPICAL 20100722 OTC MONOGRAPH NOT FINAL part333E Topco Associates llc TRICLOSAN .6 mL/100mL N 20181231 36800-169_83b371aa-6213-457f-8f53-d206c9213b7d 36800-169 HUMAN OTC DRUG ANTIBACTERIAL FOAMING COMPLETE TRICLOSAN LIQUID TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN .46 mL/100mL N 20181231 36800-170_d0ea86ae-8527-4a91-bf77-28c64d2e429d 36800-170 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050419 ANDA ANDA076789 Topco Associates LLC NICOTINE 4 mg/1 N 20181231 36800-171_75a8f71f-a645-4157-8488-97bb93889c2a 36800-171 HUMAN OTC DRUG Salicylic Acid One Step Corn Remover PATCH TOPICAL 20120328 OTC MONOGRAPH FINAL part358F Topco Associates LLC SALICYLIC ACID 40 mg/61 N 20181231 36800-172_a47335eb-ad54-4fc9-a582-d633b49ced98 36800-172 HUMAN OTC DRUG Salicylic Acid One Step Wart Remover Clear Strips PLASTER TOPICAL 20140218 OTC MONOGRAPH FINAL part358B Topco Associates LLC SALICYLIC ACID 40 mg/141 N 20181231 36800-174_a381599b-221e-4f9f-b02a-01caaf300ba8 36800-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA021920 TOP CARE (Topco Associates LLC) NAPROXEN SODIUM 220 mg/1 N 20181231 36800-176_707946c1-00b7-4170-9222-9a4d4289f719 36800-176 HUMAN OTC DRUG Topcare All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080519 ANDA ANDA077170 Topco Associates LLC CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 36800-177_f2c55881-f4b9-4e89-a637-5ecee5f447d7 36800-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111107 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN .46 mL/100mL N 20181231 36800-178_388638b9-d8ae-4377-9574-b6f52246b5a8 36800-178 HUMAN OTC DRUG TOPCO ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20111118 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN .6 mL/100mL N 20181231 36800-179_e7b6e184-65a4-432b-a90b-d0b687e952ef 36800-179 HUMAN OTC DRUG topcare antacid calcium Calcium carbonate TABLET, CHEWABLE ORAL 19930429 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 750 mg/1 N 20181231 36800-182_a54eadf8-1ca5-4d7f-8aeb-c87b16283efd 36800-182 HUMAN OTC DRUG Topcare antacid calcium calcium carbonate TABLET, CHEWABLE ORAL 20160303 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 750 mg/1 N 20181231 36800-183_5f9f439e-4d1b-429b-9d91-b3b4329b6c1e 36800-183 HUMAN OTC DRUG Topcare Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19930422 ANDA ANDA077349 Topco Associates LLC IBUPROFEN 200 mg/1 N 20181231 36800-184_4fc3ce55-8ce2-487c-9623-2ccc41a990ae 36800-184 HUMAN OTC DRUG ANTIBACTERIAL FRESH PEAR TRICLOSAN SOLUTION TOPICAL 20110803 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN .46 mL/100mL N 20181231 36800-185_e16ccad5-f10f-4a0b-884f-84bf6597d715 36800-185 HUMAN OTC DRUG Live Better Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 TOPCO Assoc. LLC SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 36800-186_0d0aa0e3-c7b5-4165-92e3-a65249a9d622 36800-186 HUMAN OTC DRUG Top Care Enamel Guard Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 TOPCO Assoc. LLC SODIUM FLUORIDE; POTASSIUM NITRATE 1.5; 5 g/g; g/g N 20181231 36800-187_5fc3d210-5ff0-4b23-afa4-c6df60f982a7 36800-187 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20140331 OTC MONOGRAPH NOT FINAL part343 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 36800-188_09ea59a7-267c-4e91-a671-2856b96cc2e0 36800-188 HUMAN OTC DRUG Topcare hemorrhoidal Mineral oil, petrolatum, phenylephrine hcl OINTMENT RECTAL 20130722 OTC MONOGRAPH FINAL part346 Topco Associates LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/100g; mg/100g; mg/100g E 20171231 36800-189_cf2be1c9-553f-43eb-82a2-54d5d8365d84 36800-189 HUMAN OTC DRUG Topcare Childrens All Day Allergy Cetirizine HCl SOLUTION ORAL 20131223 ANDA ANDA204226 Topco Associates LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 36800-190_70c8c382-b914-4489-8232-c607820013a3 36800-190 HUMAN OTC DRUG Bisacody Enteric Coated Bisacodyl TABLET, COATED ORAL 20130110 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) BISACODYL 5 mg/1 N 20181231 36800-194_a7e1dd23-600e-4daf-afed-46b05cc9425c 36800-194 HUMAN OTC DRUG TopCare Acid Reducer Famotidine TABLET ORAL 20060928 ANDA ANDA077351 Topco Associates LLC FAMOTIDINE 20 mg/1 N 20181231 36800-195_d1a4c321-1dc6-4063-a653-f02d75b63fad 36800-195 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FRESH PEAR TRICLOSAN LIQUID TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC TRICLOSAN 4.6 mg/mL N 20181231 36800-198_28a2a9f0-2e9d-4205-a833-6eac9df7d0b0 36800-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130430 ANDA ANDA078682 TOP CARE (Topco Associates LLC) IBUPROFEN 200 mg/1 N 20181231 36800-199_e6701b15-8238-4af7-b8dc-778baa254eaa 36800-199 HUMAN OTC DRUG topcare miconazole 1 Miconazole nitrate KIT 20100617 ANDA ANDA079114 Topco Associates LLC N 20181231 36800-200_9e038bb0-8635-42d3-87c5-8be09049412b 36800-200 HUMAN OTC DRUG Topcare ZZZ Sleep Diphenhydramine HCl SOLUTION ORAL 20130820 OTC MONOGRAPH FINAL part338 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 36800-202_fd84e834-d86d-4cc5-8cc0-5c063fa2ee03 36800-202 HUMAN OTC DRUG topcare childrens pain and fever Acetaminophen SUSPENSION ORAL 19900115 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL N 20181231 36800-203_2b39312e-6fe4-4281-99e2-a3cc77f77085 36800-203 HUMAN OTC DRUG Topcare Antacid Calcium Calcium carbonate TABLET, CHEWABLE ORAL 20160208 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 750 mg/1 N 20181231 36800-205_4f439074-e7ce-4494-b33e-e9eaeb0a2698 36800-205 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20051227 OTC MONOGRAPH FINAL part358H Topco Associates LLC COAL TAR 25 mg/mL N 20181231 36800-206_0e693f6d-49c8-47c1-8d6a-1959cdeb2917 36800-206 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050422 ANDA ANDA078325 Topco Associates LLC NICOTINE 2 mg/1 N 20181231 36800-207_5d6b7cf1-1e23-7ea8-e053-2a91aa0a58d3 36800-207 HUMAN OTC DRUG Top Care Decolorized Iodine Ethyl Alcohol LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A TOPCO ASSOCIATES LLC ALCOHOL .45 mL/mL N 20181231 36800-209_7a0fa0a1-106d-443f-916b-21960fe63608 36800-209 HUMAN OTC DRUG Topco Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 Topco SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 36800-210_66b80104-a39e-445c-9a6d-dc586902b871 36800-210 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 19920720 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 36800-211_8878060d-c127-4f04-b48a-5e12a64cdd49 36800-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20130430 NDA NDA022429 TOP CARE (Topco Associates LLC) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 36800-213_ca2d39ad-06ad-4d77-ac82-4b526e43c681 36800-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20031020 OTC MONOGRAPH FINAL part355 Topco Associates, LLC SODIUM FLUORIDE .2 mg/mL N 20181231 36800-214_c3ae940f-ea04-4d45-85e9-19a25f1417eb 36800-214 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090515 OTC MONOGRAPH NOT FINAL part356 TOP CARE (Topco Associates LLC) HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 36800-216_2901e605-82dd-4f1f-bb7a-ff9475e654f4 36800-216 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130430 ANDA ANDA079174 TOP CARE (Topco Associates LLC) IBUPROFEN 200 mg/1 N 20181231 36800-218_8e5b5f87-9981-4863-92fc-61a2c45d6230 36800-218 HUMAN OTC DRUG Clear Anti Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 20090603 OTC MONOGRAPH FINAL part347 TOPCO ASSOCIATES PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 36800-220_bc24e462-e0d7-4887-9c6e-f425471221f7 36800-220 HUMAN OTC DRUG Topcare mucus relief Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20170803 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 36800-222_17f06ed8-b876-4c9e-998a-63ba924b318e 36800-222 HUMAN OTC DRUG topcare fluticasone propionate nasal Fluticasone propionate SPRAY, METERED NASAL 20160624 ANDA ANDA207957 Topco Associates LLC FLUTICASONE PROPIONATE 50 ug/1 N 20181231 36800-223_0266fdf3-1f38-4806-a8d1-8817e6f54a82 36800-223 HUMAN OTC DRUG Alcohol Free Antiseptic Oral Cetylpyridiium chloride RINSE ORAL 19900215 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC CETYLPYRIDINIUM CHLORIDE .07 mL/100L N 20181231 36800-224_b77b745d-0dd0-43b8-aa3d-7a8b364d9b5b 36800-224 HUMAN OTC DRUG topcare anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030226 ANDA ANDA075232 Topco Associates LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 36800-227_845ff657-50a8-4d1c-9942-d1eb6121124a 36800-227 HUMAN OTC DRUG Topcare Pain Relief Acetaminophen TABLET, COATED ORAL 20060414 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 500 mg/1 N 20181231 36800-228_c9d94bfa-83e7-4f7a-b8c3-f74addd652ee 36800-228 HUMAN OTC DRUG Topco Arthritis 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Topco Associates LLC ACETAMINOPHEN 650 mg/1 N 20181231 36800-229_a1698fcc-6d37-4404-b519-b0de5a9b8c0d 36800-229 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130331 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 36800-230_7241f0c7-d2d7-40c8-9202-c570744aab22 36800-230 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20130531 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 36800-231_b27e7eff-8fd5-47e1-bdb8-3ff137ff1e8c 36800-231 HUMAN OTC DRUG TOPCARE 2 IN 1 DANDRUFF GREEN APPLE PYRITHIONE ZINC LIQUID TOPICAL 20140727 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL N 20181231 36800-231_c3dfee8c-df66-46e6-a90e-3f916709d1e3 36800-231 HUMAN OTC DRUG TopCare 2 in 1 Dandruff Green Apple Pyrithione Zinc LIQUID TOPICAL 20170515 OTC MONOGRAPH FINAL part358H TopCo Associates LLC PYRITHIONE ZINC 10 mg/mL N 20181231 36800-235_81900a03-9392-4236-91e8-c07fc237eadc 36800-235 HUMAN OTC DRUG TOPCARE HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20111120 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 62 mL/100mL N 20181231 36800-236_ee88d2e0-882a-4bd2-b402-2233217b6198 36800-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 36800-238_b47dc2ab-e2ac-48c1-9458-0f5c779d9153 36800-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) DOCUSATE SODIUM 100 mg/1 N 20181231 36800-240_081f4359-b07d-4a39-8f58-b48635c066f8 36800-240 HUMAN OTC DRUG FOAMING HAND SANITIZER BENZALKONIUM CHLORIDE GEL TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 36800-242_0d60f9f4-9e6a-4e97-a45f-5a3eae155bbb 36800-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part347 TOP CARE (Topco Associates LLC) DIMETHICONE 125 mg/1 N 20181231 36800-244_9b26e69e-dccf-4dce-960a-61a127a951ad 36800-244 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Topco Associates LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 36800-245_c08606c3-86c6-4093-92d7-ea904b825b60 36800-245 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20140228 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) SENNOSIDES 25 mg/1 N 20181231 36800-247_26a42664-6620-4a5c-8d60-63ee3783df11 36800-247 HUMAN OTC DRUG Healing Petrolatum OINTMENT TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Topco Associates LLC PETROLATUM 340 g/g N 20181231 36800-248_cde6129e-eb0e-4fb4-96e3-55f51ebb2830 36800-248 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20140228 ANDA ANDA079174 TOP CARE (Topco Associates LLC) IBUPROFEN 200 mg/1 N 20181231 36800-249_a8058add-c494-4cc5-a955-5a6046a2248d 36800-249 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20140430 ANDA ANDA079174 TOP CARE (Topco Associates LLC) IBUPROFEN 200 mg/1 N 20181231 36800-250_15fb6ee4-aee3-50f4-e054-00144ff8d46c 36800-250 HUMAN OTC DRUG Cold Relief Multi-Symptom Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride KIT 20111001 OTC MONOGRAPH FINAL part341 TopCare N 20181231 36800-253_20202aed-c9b3-4431-834d-612d65c3a9e6 36800-253 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100202 OTC MONOGRAPH NOT FINAL part333 Topco Associates llc ALCOHOL 65 mL/100mL N 20181231 36800-254_7c0bfa96-d932-46ac-a7fb-70a11e1c7d5d 36800-254 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 TOPCO ASSOCIATES LLC ALCOHOL 65 mL/100mL N 20181231 36800-255_9e216cbf-4aa6-46cb-9a1b-8ea80248f82b 36800-255 HUMAN OTC DRUG Topcare Ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20040910 ANDA ANDA075217 Topco Associates LLC IBUPROFEN 50 mg/1.25mL N 20181231 36800-256_8b94128e-15d1-4840-950f-0ffabf79e6c1 36800-256 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140630 ANDA ANDA091353 TOP CARE (Topco Associates LLC) NAPROXEN SODIUM 220 mg/1 N 20181231 36800-258_0d60facb-3cc0-4f52-b32a-b5a36d1ffe0e 36800-258 HUMAN OTC DRUG TOPCARE CITRUS ESCAPE ETHYL ALCOHOL LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL N 20181231 36800-258_4ae4a096-0e9c-4880-a1c6-5b322bc4a726 36800-258 HUMAN OTC DRUG TOPCARE CITRUS ESCAPE ETHYL ALCOHOL LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL N 20181231 36800-259_bdfb8978-c377-4130-a142-014b25534b49 36800-259 HUMAN OTC DRUG Topcare Aspirin Aspirin TABLET, CHEWABLE ORAL 20060428 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ASPIRIN 81 mg/1 N 20181231 36800-262_aa37fc79-7e8f-4a6e-b41d-00f8d2636325 36800-262 HUMAN OTC DRUG TOPCARE APPLE POMEGRANATE ETHYL ALCOHOL LIQUID TOPICAL 20130318 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL N 20181231 36800-262_bff8e675-ffe9-44c1-8256-fdcc07afe08c 36800-262 HUMAN OTC DRUG TOPCARE APPLE POMEGRANATE ETHYL ALCOHOL LIQUID TOPICAL 20130318 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL N 20181231 36800-263_08cd06e4-600b-4431-a5b5-20c9aecd413c 36800-263 HUMAN OTC DRUG Menthol Maximum Strength Medicated Foot Powder POWDER TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC MENTHOL 2.8 g/283g N 20181231 36800-265_4bf9f964-1d4f-4e19-9d54-b86ab3b799f3 36800-265 HUMAN OTC DRUG Topcare Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130627 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 36800-266_3cc83690-405f-448e-8994-61b467b88896 36800-266 HUMAN OTC DRUG TOPCARE JASMINE TEA AND BASIL ETHYL ALCOHOL LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL N 20181231 36800-266_fdb1bd27-861c-4295-b0af-a2f973afd148 36800-266 HUMAN OTC DRUG TOPCARE JASMINE TEA AND BASIL ETHYL ALCOHOL LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL N 20181231 36800-272_d0e46aa0-616a-4be1-bdb8-a0c516abb0a4 36800-272 HUMAN OTC DRUG Topcare Sinus Congestion and Pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070112 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 36800-273_7d3be962-3c4a-44da-8a2f-f92b87b98a9e 36800-273 HUMAN OTC DRUG Topcare Antibacterial Foaming White Tea Benzalkonium Chloride LIQUID TOPICAL 20170427 OTC MONOGRAPH NOT FINAL part333E Topco Associates LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-273_fec63ff9-aa04-444b-a6f6-222ef296db7a 36800-273 HUMAN OTC DRUG TOPCARE ANTIBACTERIAL FOAMING WHITE TEA BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 36800-274_d570642f-350b-43f0-b9ad-e59b4aeef0d7 36800-274 HUMAN OTC DRUG Topcare Aspirin Aspirin TABLET, CHEWABLE ORAL 20050329 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ASPIRIN 81 mg/1 N 20181231 36800-275_090f6eba-c3c7-4ffa-9a32-3de082176bc3 36800-275 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A TOP CARE (Topco Associates LLC) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 36800-276_356f7aac-4d83-48e2-b499-4e0a90a15f71 36800-276 HUMAN OTC DRUG Isopropyl Alcohol 70 Percent Isopropyl Alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A TOP CARE (Topco Associates LLC) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 36800-279_a4c5be5c-4149-4f97-a287-41a839db2b43 36800-279 HUMAN OTC DRUG topcare hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141103 OTC MONOGRAPH FINAL part346 Topco Associates LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 36800-281_4b23a69e-c40e-4163-8f0d-3545968def27 36800-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20020528 OTC MONOGRAPH FINAL part358H Topco Associates LLC PYRITHIONE ZINC 1 kg/100L N 20181231 36800-282_18892e40-e033-43c9-9645-b49b4b42cb75 36800-282 HUMAN OTC DRUG Topcare Dayhist Allergy Clemastine fumarate TABLET ORAL 19960723 ANDA ANDA074512 Topco Associates LLC CLEMASTINE FUMARATE 1.34 mg/1 N 20181231 36800-283_3552ebb3-f8f1-2431-e054-00144ff88e88 36800-283 HUMAN OTC DRUG Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN and CAFFEINE TABLET ORAL 20160101 OTC MONOGRAPH NOT FINAL part343 TOPCO ASSOCIATES LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 36800-285_f6fd8623-f4d7-44a8-9003-9c7e2b51d51e 36800-285 HUMAN OTC DRUG Top Care Brilliant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 TOPCO Assoc. LLC SODIUM FLUORIDE .243 g/100g N 20181231 36800-288_0c5a7519-3fa8-43d5-8958-363b51d85eed 36800-288 HUMAN OTC DRUG Topcare Mucus Relief Guaifenesin LIQUID ORAL 20071101 OTC MONOGRAPH FINAL part341 Topco Associates LLC GUAIFENESIN 100 mg/5mL N 20181231 36800-291_263d6b55-9e0c-43d9-948d-7208c502e4c7 36800-291 HUMAN OTC DRUG topcare nite time cold and flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20150804 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 36800-292_d442f959-6a46-4566-a873-ae03088f8214 36800-292 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Topco Associates, LLC IBUPROFEN 200 mg/1 N 20191231 36800-293_2d3e13f6-f112-4a80-91bf-f4f501cb6057 36800-293 HUMAN OTC DRUG Topcare Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20150204 OTC MONOGRAPH FINAL part341 Topco Associates LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 36800-296_cf2a14b1-4ae8-4287-a1d1-a27e8a55692f 36800-296 HUMAN OTC DRUG topcare tussin cf max dextromethorphan hbr, guaifenesin, phenylephrine hcl SUSPENSION ORAL 20120808 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 36800-297_9f47e2de-ce4d-4d41-bb3f-aab0bb5da013 36800-297 HUMAN OTC DRUG Cough and Runny Nose Childrens Plus Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide SUSPENSION ORAL 20151231 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 36800-299_ab3b5cd1-a77a-4a56-9bc7-12ef511c932c 36800-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 19930803 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 36800-300_f9fcd2ac-95bd-4ca6-8ade-337dd0bb7eb9 36800-300 HUMAN OTC DRUG Topcare Tussin Cough Long Acting Dextromethorphan Hydrobromide SOLUTION ORAL 19921021 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL N 20181231 36800-302_9e33574a-f12e-4641-a19e-aa3678654094 36800-302 HUMAN OTC DRUG Topcare stomach relief original strength Bismuth subsalicylate SUSPENSION ORAL 19890115 OTC MONOGRAPH FINAL part335 Topco Associates LLC BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 36800-303_8aee01c5-b9c4-4692-ae7a-3749215da95a 36800-303 HUMAN OTC DRUG Topcare Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20160323 ANDA ANDA206581 Topco Associates LLC IBUPROFEN SODIUM 256 mg/1 N 20181231 36800-304_296b936b-78e0-4cfc-9ebb-f3916101f1a7 36800-304 HUMAN OTC DRUG Topcare Nasal oxymetazoline hydrochloride SPRAY NASAL 19891215 OTC MONOGRAPH FINAL part341 Topco Associates LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 36800-306_84d6111b-9f4d-4e45-8a74-a6d2ef6c8f41 36800-306 HUMAN OTC DRUG Topcare ClearLax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Topco Associates LLC POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 36800-309_45a19ba9-5ae9-4b2e-be37-86aae170f35b 36800-309 HUMAN OTC DRUG DANDRUFF Pyrithione zinc SHAMPOO TOPICAL 20170619 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 1 g/100mL N 20181231 36800-309_8ac0cbdc-ad65-496a-a391-77fbd7384dfd 36800-309 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20110210 OTC MONOGRAPH FINAL part358H Topco Associates PYRITHIONE ZINC 1 g/100mL N 20181231 36800-313_7ba765a1-8ca1-4431-ae9c-be5f8aa9bb97 36800-313 HUMAN OTC DRUG topcare day time nite time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Guaifenesin, Phenylephrine HCl KIT 20150912 OTC MONOGRAPH FINAL part341 Topco Associates LLC N 20181231 36800-315_d9632349-65ef-4a5e-8214-e0b17d58db79 36800-315 HUMAN OTC DRUG TopCare Nasoflow Allergy Relief Fluticasone propionate SPRAY, METERED NASAL 20160527 ANDA ANDA207957 Topco Associates LLC FLUTICASONE PROPIONATE 50 ug/1 N 20181231 36800-316_ea24cce8-16f1-415f-a7d4-8330a5fb83d3 36800-316 HUMAN OTC DRUG Severe Cold and Cough Daytime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20151130 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 36800-317_9e324a98-bd2f-4c97-8827-6ad91f6e15c3 36800-317 HUMAN OTC DRUG Flu Relief Therapy Nighttime Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 36800-318_65d8e3d3-3abb-4128-b11b-2ea5e1ad595d 36800-318 HUMAN OTC DRUG Original Antiseptic EUCALYPTOL, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 19900715 OTC MONOGRAPH NOT FINAL part356 Topco Associates, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 36800-323_ee801ad2-b62c-4348-8bd3-590f686775e0 36800-323 HUMAN OTC DRUG Topcare Lubricating Plus carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20130820 OTC MONOGRAPH FINAL part349 Topco Associates LLC CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM .5 g/100mL N 20181231 36800-325_67680619-0dd0-4d29-a103-b9134f0f21ca 36800-325 HUMAN OTC DRUG TopCare Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160714 ANDA ANDA091009 Topco Associates LLC GUAIFENESIN 1200 mg/1 N 20181231 36800-326_74892da6-bc3b-4f3b-bcb4-a54bcb1a3ddd 36800-326 HUMAN OTC DRUG Topcare Daily Facial Avobenzone, Octocrylene CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Topco Associates LLC AVOBENZONE; OCTOCRYLENE 3; 10 mL/100mL; mL/100mL N 20181231 36800-329_81ddc80e-36e9-401f-a518-69cc3fc863cd 36800-329 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150731 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 36800-330_4c741224-23c3-4403-9eb3-b35041761231 36800-330 HUMAN OTC DRUG TOPCARE MEDICATED WIPES WITCH HAZEL CLOTH TOPICAL 20120301 OTC MONOGRAPH FINAL part346 TOPCO ASSOCIATES LLC WITCH HAZEL .5 mL/mL N 20181231 36800-332_8ccf12b3-a421-4e0c-beb3-9271920a47cf 36800-332 HUMAN OTC DRUG Topcare Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 19930113 OTC MONOGRAPH NOT FINAL part334 Topco Associates LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 36800-333_3ec63c53-688a-4968-adb0-0bbee8dd243f 36800-333 HUMAN OTC DRUG TOPCARE GENTLE DANDRUFF GREEN APPLE PYRITHIONE ZINC LIQUID TOPICAL 20140727 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL N 20181231 36800-334_76b4c009-4346-473a-808b-7a147141d4f8 36800-334 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20161130 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) MINERAL OIL 100 mg/100mL N 20181231 36800-335_6fd9b927-585b-4b46-8054-ca600c8c8226 36800-335 HUMAN OTC DRUG topcare nite time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110818 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 36800-336_38196531-6db8-4f38-bd5a-a75d88dcfd31 36800-336 HUMAN OTC DRUG Calamine Calamine, Pramoxind HCl LOTION TOPICAL 20090521 OTC MONOGRAPH FINAL part347 Topco associates LLC FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 8.6; 20; 10 mg/mL; mg/mL; mg/mL N 20181231 36800-337_898f2130-7b79-4bac-b2f6-01ea70e9dad0 36800-337 HUMAN OTC DRUG Topcare Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 19891215 OTC MONOGRAPH FINAL part335 Topco Associates LLC BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 36800-339_e942c2f6-3b5d-4d49-9a0c-97815692c8d8 36800-339 HUMAN OTC DRUG Illuminating Daily Moisturizer Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Topco Associates LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mL/100mL; mL/100mL; mL/100mL N 20181231 36800-340_241e002a-4a31-44c3-803b-10e31f6fbcfb 36800-340 HUMAN OTC DRUG Topcare Antacid Plus Anti Gas aluminum hydroxide, magnesium hydroxide, simethicone SUSPENSION ORAL 19900715 OTC MONOGRAPH FINAL part331 Topco Associates LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 36800-344_09da4d55-aa5f-45dc-bb2d-e90e6698dea6 36800-344 HUMAN OTC DRUG Topcare Nicotine Polacrilex Nicotine Polacrilex LOZENGE ORAL 20090903 ANDA ANDA077007 Topco Associates LLC NICOTINE 2 mg/1 N 20181231 36800-352_d5d13e61-9695-4f0f-a46a-f358efbdeb5a 36800-352 HUMAN OTC DRUG Topcare nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20100128 ANDA ANDA078547 Topco Associates LLC NICOTINE 2 mg/1 N 20181231 36800-353_7511c32a-6437-4f60-9b1d-ea2e963ad07f 36800-353 HUMAN OTC DRUG bleve bvibrant Octyl Methoxycinnamate LOTION TOPICAL 20120319 OTC MONOGRAPH NOT FINAL part352 TOPCO ASSOCIATES LLC OCTINOXATE; AVOBENZONE 2; .5 mL/100mL; mL/100mL N 20181231 36800-354_7faae4e2-f375-44df-bb05-1c8cca4c3ebb 36800-354 HUMAN OTC DRUG Body Wash Salicylic Acid GEL TOPICAL 20150115 OTC MONOGRAPH FINAL part333D TopCo Associates LLC SALICYLIC ACID 25 mg/mL N 20181231 36800-355_c43c97a2-828a-4b16-9884-3f8a65716162 36800-355 HUMAN OTC DRUG Topcare Headache PM Formula Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19970825 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 36800-357_ad7392a5-47ef-4900-8b6b-b79f34aecbaa 36800-357 HUMAN OTC DRUG Topcare Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 19900815 OTC MONOGRAPH FINAL part331 Topco Associates LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 36800-359_497da7a9-a6db-465e-94dc-314e5610b055 36800-359 HUMAN OTC DRUG Topcare Tussin DM Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 19910814 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 36800-360_611d64de-86da-4807-a1a0-f0eb7a6d43bf 36800-360 HUMAN OTC DRUG Long-Lasting Oil-Free Moisturizer Avobenzone, Octisalate, Octocrylene and Oxybenzone CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Topco Associates LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 4; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 36800-361_2c3be9c8-b4f2-43b3-9a20-0202fcf2f420 36800-361 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20121019 OTC MONOGRAPH FINAL part338 Topco Associates LLC (Top Care) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 36800-368_9034d2ed-9c56-4707-a731-806a925fb026 36800-368 HUMAN OTC DRUG TopCare All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 19970114 ANDA ANDA074661 Topco Associates LLC NAPROXEN SODIUM 220 mg/1 N 20181231 36800-369_38abe710-3d8a-41b0-b057-38c5dfd53322 36800-369 HUMAN OTC DRUG Topcare 8 Hour Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170405 ANDA ANDA075077 Topco Associates LLC ACETAMINOPHEN 650 mg/1 N 20181231 36800-370_d92943d3-2a34-4501-b667-e9376a24cae7 36800-370 HUMAN OTC DRUG Advanced Ethyl Alcohol GEL TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333A TOPCO Assoc. LLC ALCOHOL 616 mg/mL N 20181231 36800-372_f5ee1c17-94f1-441f-9d74-e785d3ff94f7 36800-372 HUMAN OTC DRUG Undecylenic Acid Antifungal Solution LIQUID TOPICAL 20171212 OTC MONOGRAPH FINAL part333C Topco Associates LLC UNDECYLENIC ACID 7.5 g/30g N 20181231 36800-373_59f06b25-734a-4e1c-ae29-fba9297a1f4b 36800-373 HUMAN OTC DRUG Salicylic acid Medicated Callus Removers Extra Thick PATCH TOPICAL 20171206 OTC MONOGRAPH FINAL part358F Topco Associates LLC SALICYLIC ACID 40 mg/41 N 20181231 36800-374_6b3379e0-b8b0-4571-9383-1406ec084d95 36800-374 HUMAN OTC DRUG Topcare Migraine Formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20030401 ANDA ANDA075794 Topco Associates LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 36800-375_94e321ca-7ad5-4a5d-b0a0-0a6e089c288a 36800-375 HUMAN OTC DRUG topcare nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 19980622 ANDA ANDA090711 Topco Associates LLC NICOTINE 2 mg/1 N 20181231 36800-376_d4f4d3f7-024c-4d82-8164-87842649d741 36800-376 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid LIQUID TOPICAL 20171206 OTC MONOGRAPH FINAL part358B Topco Associates LLC SALICYLIC ACID .17 mg/9mL N 20181231 36800-377_8ed063ab-e700-42a9-a530-17780915438d 36800-377 HUMAN OTC DRUG Salicylic acid Wart Remover PLASTER TOPICAL 20171206 OTC MONOGRAPH FINAL part358B Topco Associates LLC SALICYLIC ACID .4 g/181 N 20181231 36800-378_94f8b1e9-2df1-4619-87c3-3c805cd39ea4 36800-378 HUMAN OTC DRUG Salicylic Acid Medicated Plantar Wart Remover PATCH TOPICAL 20171206 OTC MONOGRAPH FINAL part358B Topco Associates LLC SALICYLIC ACID 40 mg/241 N 20181231 36800-379_41b379e9-00cf-4696-b6a2-650a7afa6642 36800-379 HUMAN OTC DRUG Topcare childrens allergy Diphenhydramine Hydrochloride SOLUTION ORAL 19871215 OTC MONOGRAPH FINAL part341 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 36800-381_604cbf77-d2d0-4322-ab6f-e7d61fa2d276 36800-381 HUMAN OTC DRUG TopCare Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Topco Associates LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 36800-382_cb4e84dd-c384-4c13-b6e7-d85f050099e0 36800-382 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20140710 OTC MONOGRAPH NOT FINAL part333A Topco Associates LLC BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/9mL; mg/9mL N 20181231 36800-384_7aa9a5a4-0858-4ce0-8c1e-12de505bc7cb 36800-384 HUMAN OTC DRUG Miconazole Nitrate Athletes Foot Powder Spray Talc Free AEROSOL, POWDER TOPICAL 20171207 OTC MONOGRAPH FINAL part333C Topco Associates LLC MICONAZOLE NITRATE 2.6 g/130g N 20181231 36800-385_b375af10-52db-4c1a-a46f-6430b956eda6 36800-385 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Powder Miconazole Nitrate Talc Free POWDER TOPICAL 20171207 OTC MONOGRAPH FINAL part333C Topco Associates LLC MICONAZOLE NITRATE 1.42 g/71g N 20181231 36800-388_b5434599-5485-4949-9d76-b1ef3ad17c1a 36800-388 HUMAN OTC DRUG Topcare Nasal Oxymetazoline HCl SPRAY NASAL 20021126 OTC MONOGRAPH FINAL part341 Topco Associates LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 36800-395_bbf7ac7b-8576-4013-8083-71e189536d5f 36800-395 HUMAN OTC DRUG Epsom Salt Magnesium sulfate GRANULE ORAL; TOPICAL 20140430 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) MAGNESIUM SULFATE 1 g/g N 20181231 36800-396_8013f1e8-4500-4c29-b8e4-71c8fc241c6d 36800-396 HUMAN OTC DRUG Topcare Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 19910910 OTC MONOGRAPH NOT FINAL part334 Topco Associates LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 36800-397_87e81869-d606-4a01-8c99-1c1c81e4eb17 36800-397 HUMAN OTC DRUG Topcare pain and fever childrens acetaminophen SUSPENSION ORAL 20120228 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL N 20181231 36800-398_c78c47c3-1989-4086-8cb1-cade9ef5d162 36800-398 HUMAN OTC DRUG Calamine Plus Pramoxine HCl Calamine Plus Spray AEROSOL, SPRAY TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE .345; 24.16; 2.72 mg/116g; mg/116g; mg/116g N 20181231 36800-401_2b990bef-bd31-114d-e054-00144ff88e88 36800-401 HUMAN OTC DRUG Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% LIQUID TOPICAL 20131101 NDA NDA019125 Topco Associates LLC CHLORHEXIDINE GLUCONATE 4 mg/100mL N 20181231 36800-404_4e417072-b10a-4f12-8ab2-63ccfb1088cf 36800-404 HUMAN OTC DRUG topcare arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070820 ANDA ANDA075077 Topco Associates LLC ACETAMINOPHEN 650 mg/1 N 20181231 36800-407_30f72640-7db4-4a0e-a685-460d9fcb99eb 36800-407 HUMAN OTC DRUG TopCare Cold Sore Treatment Camphor CREAM TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 36800-410_5e713bdc-c9b4-49de-9083-c2b3bf6f7189 36800-410 HUMAN OTC DRUG Day Time Cold and Flu Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI CAPSULE, LIQUID FILLED ORAL 20160613 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; 1/1; mg/1; mg/1 N 20181231 36800-411_fed7dcd4-9313-47ab-9653-2629bfddc7e7 36800-411 HUMAN OTC DRUG Night Time Cold and Flu Severe Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20160602 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 36800-412_48e260f6-0a95-4e74-9743-b30f056517d4 36800-412 HUMAN OTC DRUG DayTime Cold and Flu Severe and NightTime Cold and Flu Severe acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, phenylephrine hydrochloride KIT 20160628 OTC MONOGRAPH FINAL part341 Topco Associates LLC N 20181231 36800-413_4c9c705b-d234-4233-85b1-1298749394ef 36800-413 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160719 OTC MONOGRAPH FINAL part338 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 36800-414_0e85cdfd-ff9e-440d-ad29-e6a87cd3ea5a 36800-414 HUMAN OTC DRUG Extra Strength Pain Relief ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20160711 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 500 mg/1 N 20181231 36800-415_06c998d7-8af3-40e9-916a-3380fcf7f8d1 36800-415 HUMAN OTC DRUG Cough Relief DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20160706 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 36800-417_7e208b43-4802-4512-b419-f59e75d2babc 36800-417 HUMAN OTC DRUG Topcare Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130814 ANDA ANDA076518 Topco Associates LLC NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 36800-419_c8448ea2-c393-44c0-92e2-80c834df2b1f 36800-419 HUMAN OTC DRUG Topcare Mucus Relief Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 20071127 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 36800-421_639f9d57-f26b-708a-e053-2a91aa0a6962 36800-421 HUMAN OTC DRUG TopCare Effervescent Antacid and Pain Relief Aspirin, Citric Acid, Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20140811 OTC MONOGRAPH FINAL part343 Topco Associates LLC ASPIRIN; SODIUM BICARBONATE; ANHYDROUS CITRIC ACID 325; 1916; 1000 mg/1; mg/1; mg/1 N 20191231 36800-422_cb0cc76d-6d83-4a1c-8a7c-84755ffd6b87 36800-422 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050426 20180901 ANDA ANDA078326 Topco Associates LLC NICOTINE 4 mg/1 N 20181231 36800-423_ea0fe758-a552-4b80-9e0c-95d3e8053334 36800-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011008 ANDA ANDA074567 Topco Associates LLC IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 36800-424_1fcccdd5-4dd6-43fd-a8f3-0c32bb897587 36800-424 HUMAN OTC DRUG TOPCARE 2 IN 1 DANDRUFF EVERYDAY CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20140727 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL N 20181231 36800-424_d1193f63-e969-4656-98ee-70d901cd1968 36800-424 HUMAN OTC DRUG TopCare 2 in 1 Dandruff Everyday Clean Pyrithione Zinc LIQUID TOPICAL 20170428 OTC MONOGRAPH FINAL part358H TopCo Associates LLC PYRITHIONE ZINC 10 mg/mL N 20181231 36800-425_59d23a88-396b-497a-b3c3-d36da47d881d 36800-425 HUMAN OTC DRUG Topcare fexofenadine hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110902 ANDA ANDA076447 Topco Associates LLC FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 36800-426_348f396d-1445-4215-b2b0-432633486590 36800-426 HUMAN OTC DRUG Topcare Tioconazole 1 Tioconazole OINTMENT VAGINAL 20080303 ANDA ANDA075915 Topco Associates LLC TIOCONAZOLE 6.5 g/100g N 20181231 36800-427_24f2a5a6-c263-4bdd-b553-6ef52e80766c 36800-427 HUMAN OTC DRUG TOPCARE GENTLE DANDRUFF EVERYDAY CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20140727 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL N 20181231 36800-427_47a3a1e7-0101-435f-af9d-df72952b19fb 36800-427 HUMAN OTC DRUG TopCare Gentle Dandruff Everyday Clean Pyrithione Zinc LIQUID TOPICAL 20170428 OTC MONOGRAPH FINAL part358H TopCo Associates LLC PYRITHIONE ZINC 10 mg/mL N 20181231 36800-427_549e24f3-0b83-42ae-a177-74c45bfaa5b2 36800-427 HUMAN OTC DRUG TOPCARE GENTLE DANDRUFF EVERYDAY CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20140724 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL N 20181231 36800-429_70f2d090-d0e6-4aa4-a921-66e89b2eb3c9 36800-429 HUMAN OTC DRUG TOPCARE GENTLE DANDRUFF DRY SCALP PYRITHIONE ZINC LIQUID TOPICAL 20140727 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC PYRITHIONE ZINC 10 mg/mL N 20181231 36800-429_93b21966-a435-46e2-885f-b31127d8c599 36800-429 HUMAN OTC DRUG TopCare Gentle Dandruff Dry Scalp Pyrithione Zinc LIQUID TOPICAL 20170428 OTC MONOGRAPH FINAL part358H TopCo Associates LLC PYRITHIONE ZINC 10 mg/mL N 20181231 36800-431_1609b447-1f7a-47df-9424-de348f32be62 36800-431 HUMAN OTC DRUG topcare sleep aid nighttime Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20010911 OTC MONOGRAPH FINAL part338 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 36800-432_bd432d18-d31f-466f-b90e-b8d288c99ee1 36800-432 HUMAN OTC DRUG Topcare Nasal Decongestant Maximum Strength Non Drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 19880115 OTC MONOGRAPH FINAL part341 Topco Associates LLC PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 36800-434_25f33b4a-9e77-4aca-94ee-e8a5216e0d87 36800-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130801 OTC MONOGRAPH NOT FINAL part356 TopCo Associates, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 36800-435_110b62f3-da67-4de6-8726-2177e860fb4c 36800-435 HUMAN OTC DRUG Regular Strength Pain Relief ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20160711 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 325 mg/1 N 20181231 36800-435_1add95c8-6d81-4a4b-b304-5717f2f9033d 36800-435 HUMAN OTC DRUG Regular Strength Pain Relief ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20170105 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 325 mg/1 N 20181231 36800-437_1f646cef-a740-402f-b403-7ed0ebc001ad 36800-437 HUMAN OTC DRUG Topcare pain relief PM extra strength non habit forming Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19920721 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 36800-439_b1360ac4-ca82-4ad5-8c5c-f702ffed7608 36800-439 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130530 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 36800-441_c90c6bc7-ae9e-4496-a25b-be3480d3ad79 36800-441 HUMAN OTC DRUG TopCare Sleep Aid Doxylamine succinate TABLET ORAL 19970129 ANDA ANDA040167 Topco Associates LLC DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 36800-443_9635d527-0948-4be4-b09b-d7c3eb51122c 36800-443 HUMAN OTC DRUG Topcare Maximum Strength Benzocaine LIQUID ORAL 20141001 OTC MONOGRAPH FINAL part333B Topco BENZOCAINE 20 g/100g N 20181231 36800-446_3b4b86f9-eb7d-532e-e054-00144ff88e88 36800-446 HUMAN OTC DRUG Allergy Relief CHLORPHENIRAMINE MALEATE TABLET, COATED ORAL 20161101 OTC MONOGRAPH FINAL part341 TopCare CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 36800-447_aea0db7e-289f-449b-a595-72fea655f959 36800-447 HUMAN OTC DRUG Pain Relief PM Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20150331 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 36800-454_4dd03b8a-58ef-4e2a-851a-da4ca96c63a3 36800-454 HUMAN OTC DRUG Cough Relief Childrens Dextromethorphan HBr LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 36800-456_e38848d5-f954-410d-adbd-79e6b909e60a 36800-456 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061218 ANDA ANDA076777 Topco Associates LLC NICOTINE 2 mg/1 N 20181231 36800-458_fcd9b1f4-2ec7-4462-a29f-e941fb5d995b 36800-458 HUMAN OTC DRUG TopCare All Day Allergy Cetirizine Hydrochloride TABLET ORAL 20080110 ANDA ANDA078336 Topco Associates LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 36800-459_c5913eff-89d7-46c4-af95-d2e6dce571f4 36800-459 HUMAN OTC DRUG topcare nite time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110819 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 36800-461_157b0702-5e3a-4d1f-88fe-a0c0e60a5806 36800-461 HUMAN OTC DRUG Topcare Ibuprofen Junior Strength Ibuprofen TABLET, CHEWABLE ORAL 20040528 ANDA ANDA076359 Topco Associates LLC IBUPROFEN 100 mg/1 N 20181231 36800-464_8350d60a-c052-4ce7-a522-53d34bb413eb 36800-464 HUMAN OTC DRUG TOPCARE COCONUT CREAM ETHYL ALCOHOL LIQUID TOPICAL 20120319 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL N 20181231 36800-464_f0184a86-e618-4b5b-9d74-77b6bb86165c 36800-464 HUMAN OTC DRUG TOPCARE COCONUT CREAM ETHYL ALCOHOL LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E TOPCO ASSOCIATES LLC ALCOHOL 620 mg/mL N 20181231 36800-467_e5ec52dd-8a46-4953-9e0c-9739b3d070c2 36800-467 HUMAN OTC DRUG Topcare Aspirin Aspirin TABLET, CHEWABLE ORAL 19920824 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ASPIRIN 81 mg/1 N 20191231 36800-468_25e5d518-37f9-4523-8e65-9f6a2eb83ea7 36800-468 HUMAN OTC DRUG topcare antacid calcium Calcium carbonate TABLET, CHEWABLE ORAL 19970729 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 750 mg/1 N 20181231 36800-472_d37ad6fa-42da-49aa-b0c6-fbfa877bcd5b 36800-472 HUMAN OTC DRUG Allergy Relief-D24 Hour 24 Hour Loratadine and Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20160321 ANDA ANDA075706 Topco Associates LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 36800-475_48555c1f-8c2a-4ab2-9af3-d2488ca509e4 36800-475 HUMAN OTC DRUG TopCare Childrens All Day Allergy Cetirizine HCl SOLUTION ORAL 20160202 ANDA ANDA204226 Topco Associates LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 36800-476_b4372344-d1d5-4117-a530-af2a8a4a7991 36800-476 HUMAN OTC DRUG Topcare Allergy Multi Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20051209 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 36800-477_4f9cb525-7c2c-49c8-987b-bc54638cb15d 36800-477 HUMAN OTC DRUG Topcare Fiber Laxative Calcium polycarbophil TABLET, FILM COATED ORAL 19970811 OTC MONOGRAPH NOT FINAL part334 Topco Associates LLC CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 36800-481_8878c78d-128e-429b-868d-4364f9fcb364 36800-481 HUMAN OTC DRUG Topco Associates LLC Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 36800-482_62d604b2-9880-4e72-9a06-40a96c241709 36800-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20130919 OTC MONOGRAPH FINAL part355 TOPCO Associates LLC SODIUM FLUORIDE .219 mg/mL N 20181231 36800-483_d2ea6a69-6ac9-465c-8a9a-4f49bda02eae 36800-483 HUMAN OTC DRUG Allergy Relief Dye Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20160229 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 36800-484_cb5e4494-c23c-46e2-988e-d97d91a19b82 36800-484 HUMAN OTC DRUG Topcare Pain Relief Acetaminophen TABLET ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 500 mg/1 N 20181231 36800-485_7e8c9990-1f3b-45e5-b99b-b85465f99489 36800-485 HUMAN OTC DRUG TopCare Antacid Calcium Regular Strength calcium carbonate TABLET, CHEWABLE ORAL 19910910 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 500 mg/1 N 20181231 36800-487_6a1401e0-4115-41f9-b3cb-b10eb0546430 36800-487 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20160831 OTC MONOGRAPH FINAL part347 TOP CARE (Topco Associates LLC) DIMETHICONE 125 mg/1 N 20181231 36800-489_2241bab7-dc90-42da-bc07-abac1b506f77 36800-489 HUMAN OTC DRUG Topcare Antacid Calcium Extra Strength Calcium carbonate TABLET, CHEWABLE ORAL 20010403 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 750 mg/1 N 20181231 36800-490_da3ae55a-2e03-4935-a556-3dd2f3c8292e 36800-490 HUMAN OTC DRUG Topcare All Day Pain Relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Topco Associates LLC NAPROXEN SODIUM 220 mg/1 N 20181231 36800-492_96fe7ed4-6604-45a0-a32f-aa2dce736eab 36800-492 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20160630 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) SENNOSIDES 25 mg/1 N 20181231 36800-494_490f695c-e60f-43db-b3f3-a9ffbb2906dd 36800-494 HUMAN OTC DRUG TopCare Cough DM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150730 ANDA ANDA091135 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 36800-495_5ea9c208-ef94-4854-89d9-a4b72acf51ca 36800-495 HUMAN OTC DRUG TopCare Antifungal Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Topco Associates LLC CLOTRIMAZOLE 10 mg/g N 20181231 36800-499_615e87e4-79e0-44d6-b563-3bcd5a9b2d93 36800-499 HUMAN OTC DRUG topcare hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140328 OTC MONOGRAPH FINAL part346 Topco Associates LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 36800-500_15fb6ee4-aeba-50f4-e054-00144ff8d46c 36800-500 HUMAN OTC DRUG Severe Allergy Plus Sinus Headache ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130701 OTC MONOGRAPH FINAL part341 TopCare ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 36800-501_15fb6ee4-aea6-50f4-e054-00144ff8d46c 36800-501 HUMAN OTC DRUG Allergy Plus Sinus Headache Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20130701 OTC MONOGRAPH FINAL part341 TopCare ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 36800-502_15fb6ee4-aece-50f4-e054-00144ff8d46c 36800-502 HUMAN OTC DRUG Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130701 OTC MONOGRAPH FINAL part341 TopCare ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 36800-504_15fb6ee4-ae91-50f4-e054-00144ff8d46c 36800-504 HUMAN OTC DRUG Severe Cold PE Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20130701 OTC MONOGRAPH FINAL part341 TopCare ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 36800-505_15fb6ee4-ae7b-50f4-e054-00144ff8d46c 36800-505 HUMAN OTC DRUG Sinus Congestion and Pain Severe ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130701 OTC MONOGRAPH FINAL part341 TopCare ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 36800-506_2cd8c13a-d8c7-4012-8e8d-38f429435e68 36800-506 HUMAN OTC DRUG TopCare Anti-Itch Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20050920 OTC MONOGRAPH FINAL part348 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 36800-507_5a88841d-a3c7-4933-95f3-9e8400a8d71c 36800-507 HUMAN OTC DRUG Topcare ZZZ Sleep Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140128 OTC MONOGRAPH FINAL part338 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 36800-509_44421142-b1d3-4b4f-aae8-51086fc13741 36800-509 HUMAN OTC DRUG Cough Relief Adult Dextromethorphan HBr LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 36800-511_cf15bc0f-bed8-4b0a-aaaf-b7f8fc32e1ba 36800-511 HUMAN OTC DRUG TopCare Tussin DM Nighttime Cough dextromethorphan hbr, doxylamine succinate SOLUTION ORAL 20160717 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL N 20181231 36800-515_3d77b76d-ccfe-4e91-bad0-7d90f1d4ed62 36800-515 HUMAN OTC DRUG topcare tussin mucus plus chest congestion Guaifenesin SOLUTION ORAL 19900115 OTC MONOGRAPH FINAL part341 Topco Associates LLC GUAIFENESIN 200 mg/10mL N 20181231 36800-516_bee6444b-9c78-438e-bb4b-e2dd2958051e 36800-516 HUMAN OTC DRUG topcare tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 19920715 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20191231 36800-517_4dd18af5-dfc7-49d5-9ca5-86ab57f940ef 36800-517 HUMAN OTC DRUG Topcare ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060428 ANDA ANDA077349 Topco Associates LLC IBUPROFEN 200 mg/1 N 20181231 36800-518_7434d73f-807b-4fe2-9796-db2ec9a7d4ac 36800-518 HUMAN OTC DRUG TOPCARE PAIN RELIEVER SIMPLE RELIEF Caffeine, Choline Salicylate SOLUTION ORAL 20160906 OTC MONOGRAPH NOT FINAL part343 TOPCO ASSOCIATES LLC CAFFEINE; CHOLINE SALICYLATE 65; 870 mg/30mL; mg/30mL N 20181231 36800-519_f5bd477f-a810-4724-9f80-a1617a4a79c4 36800-519 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 19901115 OTC MONOGRAPH FINAL part347 Topco Associates, LLC PETROLATUM 1 g/g N 20181231 36800-520_1f48b026-f49a-471f-a17c-acc5f6a87f81 36800-520 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100716 NDA NDA021855 TOP CARE (Topco Associates LLC) LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 36800-522_66711ce6-0ba6-44f3-924d-73bd7a4f4495 36800-522 HUMAN OTC DRUG topcare day time cold and flu relief multi symptom relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20060717 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 36800-525_45e2483c-5163-4172-845c-664e4412d9e3 36800-525 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20160715 OTC MONOGRAPH NOT FINAL part343 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 36800-527_7d515ff3-fb50-4129-8d0f-cde4336c7327 36800-527 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Topcare Associates LLC LORATADINE 10 mg/1 N 20181231 36800-528_dc5acc2d-e646-4db3-97f2-77e16b4b34ef 36800-528 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Topco Associates LLC LORATADINE 10 mg/1 N 20181231 36800-531_65b0fca1-0b5f-482b-bdb8-608ee4df1b05 36800-531 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET, COATED ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 Topco Associates, LLC ACETAMINOPHEN 500 mg/1 N 20191231 36800-532_5aaea361-9d8d-4c00-9e44-0850a4d3f81c 36800-532 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061030 ANDA ANDA076779 Topco Associates LLC NICOTINE 4 mg/1 N 20181231 36800-539_43f2e092-7fbb-4075-89c7-90cf0c3bd742 36800-539 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex LOZENGE ORAL 20130212 ANDA ANDA090711 Topco Associates LLC NICOTINE 4 mg/1 N 20181231 36800-540_24ff6c4a-adc0-4e85-837b-b84398d2b133 36800-540 HUMAN OTC DRUG TopCare Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20140318 OTC MONOGRAPH FINAL part341 TOPCARE (Topco Associates LLC) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 36800-544_b28edf5d-30e4-467c-9947-842caad4a57d 36800-544 HUMAN OTC DRUG Topcare Arthritis Pain Relief Temporary Minor Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050804 ANDA ANDA075077 Topco Associates LLC ACETAMINOPHEN 650 mg/1 N 20181231 36800-548_cff52cd3-9468-4e10-b68d-2160814de82d 36800-548 HUMAN OTC DRUG topcare day time cold and flu severe acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140622 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 36800-550_103a99d1-3a27-46dd-9a00-7333e9689e5b 36800-550 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH FINAL part347 TOP CARE (Topco Associates LLC) DIMETHICONE 125 mg/1 N 20181231 36800-552_8d5cd05d-d731-49fd-a95b-a067691f5d9e 36800-552 HUMAN OTC DRUG Topcare Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120830 ANDA ANDA091135 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 36800-557_f50c6b2f-2ab7-4626-814d-bf326126180a 36800-557 HUMAN OTC DRUG Topcare Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19931214 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL N 20181231 36800-559_873084e4-e280-459d-9ea3-6b47f3a9f1f5 36800-559 HUMAN OTC DRUG topcare clear time Oxymetazoline Hydrochloride SPRAY NASAL 20150629 OTC MONOGRAPH FINAL part341 Topco Associates LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 36800-560_1f6e33ed-8766-4ee2-8138-30064082b609 36800-560 HUMAN OTC DRUG topcare nite time cold and flu acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl TABLET, FILM COATED ORAL 20150730 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 36800-564_6446edc3-e092-455e-ba05-27b3761e9049 36800-564 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20151215 OTC MONOGRAPH FINAL part333B Topco Associates LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 36800-567_3bebb45e-13ee-4fc3-8e9d-f11773baba59 36800-567 HUMAN OTC DRUG topcare day time nite time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120807 OTC MONOGRAPH FINAL part341 Topco Associates LLC N 20181231 36800-571_fa3e7ce7-6119-4b05-a899-947253429058 36800-571 HUMAN OTC DRUG topcare fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Topco Associates LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 36800-578_1c6b0621-06e7-431e-8be2-3c86f2964988 36800-578 HUMAN OTC DRUG Topcare tussin dm sugar free cough and chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19950404 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 36800-580_a914bce2-4bce-4183-ae40-2ca2bac2015a 36800-580 HUMAN OTC DRUG Topcare Nite Time Day Time Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140429 OTC MONOGRAPH FINAL part341 Topco Associates LLC N 20181231 36800-585_71fdc94c-07da-4c5a-b9ec-fe091725e07c 36800-585 HUMAN OTC DRUG Childrens Allergy Relief Diphenydramine HCl TABLET, CHEWABLE ORAL 20090320 OTC MONOGRAPH FINAL part341 Topco Associates, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20191231 36800-588_c9e08eee-30aa-4bea-8efc-f240664bbe8e 36800-588 HUMAN OTC DRUG Topcare Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone SUSPENSION ORAL 20060428 OTC MONOGRAPH FINAL part332 Topco Associates LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 36800-589_2cfa4b06-12db-42cf-81e8-369e6dbd3707 36800-589 HUMAN OTC DRUG 70% Isopropyl Rubbing Alcohol Isopropyl Rubbing Alcohol SOLUTION TOPICAL 20150828 OTC MONOGRAPH NOT FINAL part333A TOPCO ASSOCIATES LLC ISOPROPYL ALCOHOL .7 mg/mL N 20181231 36800-590_dd6305e0-4307-4977-9105-0c34f81e05a1 36800-590 HUMAN OTC DRUG topcare infants pain and fever acetaminophen SUSPENSION ORAL 19930721 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL N 20181231 36800-593_30bd1f30-aac6-4d97-952e-aca0044c2482 36800-593 HUMAN OTC DRUG Topcare Day Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20170725 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 36800-595_80f49ce7-7fed-4091-bfbf-527be22ee7d7 36800-595 HUMAN OTC DRUG topcare Antacid Calcium Ultra Strength Calcium Carbonate TABLET, CHEWABLE ORAL 20020212 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 36800-596_a0920ae9-45af-40c1-912c-d318a256a3a3 36800-596 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20160629 OTC MONOGRAPH FINAL part341 TOPCO ASSOCIATES, LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/g; kg/g; kg/g N 20181231 36800-597_4bf4deff-4039-46e9-8363-cdf8fe0e000a 36800-597 HUMAN OTC DRUG Topcare Day Time Nite Time Cold and Flu acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140628 OTC MONOGRAPH FINAL part341 Topco Associates LLC N 20181231 36800-599_428f7b6d-3df6-444f-8fe0-ee848141f28f 36800-599 HUMAN OTC DRUG Topcare mucus relief cold flu and sore throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20170803 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 36800-602_5fbcd293-0cce-43ce-ab6b-4afb76a8eeb8 36800-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 19990715 OTC MONOGRAPH NOT FINAL part334 TOPCO Associates, LLC MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 36800-603_63229080-de0c-4367-aa24-0d9079e14c66 36800-603 HUMAN OTC DRUG Topcare Day Time Cold and Flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20140613 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 36800-604_bf84ef91-3945-4510-8ffa-412ec2a08ad6 36800-604 HUMAN OTC DRUG TopCare Ibuprofen Ibuprofen TABLET ORAL 19880215 ANDA ANDA072096 Topco Associates LLC IBUPROFEN 200 mg/1 N 20181231 36800-605_38585a0f-aaaf-4589-9afd-e74f04057ba3 36800-605 HUMAN OTC DRUG Mucus Relief DM Max Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20160430 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 36800-607_f342cc57-4fdd-4c0a-bc83-b7908741a743 36800-607 HUMAN OTC DRUG topcare sinus severe Oxymetazoline hydrochloride SPRAY NASAL 20171106 OTC MONOGRAPH FINAL part341 Topco Associates LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 36800-610_d3eb067c-e627-4368-86c4-3390047d5bfa 36800-610 HUMAN OTC DRUG TopCare MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20100929 OTC MONOGRAPH FINAL part358H Topco Associates LLC SELENIUM SULFIDE 1 mL/100mL N 20181231 36800-612_a4a1e6e8-d61f-42ba-842b-3b5f073c0368 36800-612 HUMAN OTC DRUG TopCare Allergy Relief 24 hour Loratadine TABLET ORAL 20050125 ANDA ANDA076301 Topco Associates LLC LORATADINE 10 mg/1 N 20191231 36800-614_8b9874af-957d-4c0c-a558-94216d7f9f19 36800-614 HUMAN OTC DRUG Topcare Nite Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20170801 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 36800-616_8ef70327-9a04-413b-b331-f5d3a94d6b36 36800-616 HUMAN OTC DRUG topcare dual action complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160229 ANDA ANDA077355 Topco Associates LLC FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 36800-618_518763f2-eeb4-48e9-b869-bedc4645a175 36800-618 HUMAN OTC DRUG TOPCARE GENTLE DANDRUFF CLINICAL STRENGTH SELENIUM SULFIDE LIQUID TOPICAL 20140728 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC SELENIUM SULFIDE 10 mg/mL N 20181231 36800-619_c1208234-3bb5-4967-aa7d-61053e954ce6 36800-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20100903 OTC MONOGRAPH FINAL part347 TopCo Associates LLC DIMETHICONE 13.13 mg/mL N 20181231 36800-620_fc1fcb2f-03da-41d3-96cb-4a8d9cd7ff83 36800-620 HUMAN OTC DRUG Motion Sickness II Meclizine HCl TABLET ORAL 20130531 OTC MONOGRAPH FINAL part336 TOP CARE (Topco Associates LLC) MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 36800-621_ed8eaf1d-babc-47e1-930b-676ccfbf0de9 36800-621 HUMAN OTC DRUG Topcare Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20170125 ANDA ANDA078104 Topco Associates LLC TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 36800-626_a20ac843-4b3f-4dc3-ac3a-449093996b74 36800-626 HUMAN OTC DRUG Magnesium Citrate Saline Laxative Magnesium citrate LIQUID ORAL 20150731 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 36800-630_9bc8db51-eb04-4b47-9be9-1dcc90e76201 36800-630 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 20130531 OTC MONOGRAPH FINAL part336 TOP CARE (Topco Associates LLC) DIMENHYDRINATE 50 mg/1 N 20181231 36800-636_32918b45-ff9a-45bd-8d90-e008bf4d8458 36800-636 HUMAN OTC DRUG Topcare Esomeprazole Magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170922 ANDA ANDA207193 Topco Associates LLC ESOMEPRAZOLE 20 mg/1 N 20181231 36800-645_c8a37884-9b52-46be-a0e5-f62c8d51a453 36800-645 HUMAN OTC DRUG topcare loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120605 ANDA ANDA091292 Topco Associates LLC LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 36800-647_7c60f698-536c-4e26-8890-46c3a6dcd198 36800-647 HUMAN OTC DRUG Topcare Ibuprofen Ibuprofen TABLET, COATED ORAL 19881115 ANDA ANDA072096 Topco Associates LLC IBUPROFEN 200 mg/1 N 20181231 36800-648_c0f044eb-bcd1-4d68-8ab4-632bba2ba132 36800-648 HUMAN OTC DRUG Topcare Nasal Four Phenylephrine hydrochloride SPRAY NASAL 20021210 OTC MONOGRAPH FINAL part341 Topco Associates LLC PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 36800-650_03d9708a-923c-4fd3-ac3d-6ab4a4d8a804 36800-650 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170213 ANDA ANDA206393 Topco Associates LLC NICOTINE 4 mg/1 N 20181231 36800-660_5e60b7f6-ec47-495e-9597-d5217935f4c6 36800-660 HUMAN OTC DRUG Topcare Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20020702 ANDA ANDA074937 Topco Associates LLC IBUPROFEN 100 mg/5mL N 20181231 36800-664_d6f413ba-4830-420f-80cd-80f703e51d58 36800-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19921026 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 36800-666_6fd04d08-5a57-4d55-b032-20ad0703d21b 36800-666 HUMAN OTC DRUG Topcare Cough and Sore Throat Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060309 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 36800-668_e026d801-c469-46e4-a446-b4938556ed22 36800-668 HUMAN OTC DRUG topcare nite time cough Dextromethorphan Hydrobromide, Doxylamine Succinate SOLUTION ORAL 20021210 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 36800-672_8e37bca2-43dd-45c8-91f5-b7e2ad837afe 36800-672 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20150724 OTC MONOGRAPH FINAL part338 Topco Associates, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 36800-679_47ad6cb1-9a6a-4fce-a076-4ac05ef393e5 36800-679 HUMAN OTC DRUG Topcare Pain Relieving 40ct Camphor Menthol Methyl Salicylate PATCH TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part348 Topco Associates LLC CAMPHOR (SYNTHETIC); MENTHOL; MENTHYL SALICYLATE, (+/-)- .012; .057; .063 mg/g; mg/g; mg/g N 20181231 36800-680_cf9916ff-c8f2-4d64-bb2c-666b7012ef94 36800-680 HUMAN OTC DRUG TopCare Ultra Lubricant Polyethylene Glycol 400, and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20160930 OTC MONOGRAPH FINAL part349 Topco Associates LLC POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 36800-685_30778697-f33b-4d21-8092-5990c6433f0f 36800-685 HUMAN OTC DRUG Topcare ibuprofen childrens Ibuprofen SUSPENSION ORAL 19950203 ANDA ANDA074937 Topco Associates LLC IBUPROFEN 100 mg/5mL N 20181231 36800-688_e8576482-a704-4b75-8219-c178c028b18d 36800-688 HUMAN OTC DRUG Topcare Sinus Relief Oxymetazoline HCl SPRAY NASAL 20090729 OTC MONOGRAPH FINAL part341 Topco Associates LLC OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL N 20181231 36800-689_cb35a70c-d6d4-4b80-bfed-5e010a2d342c 36800-689 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr TABLET, FILM COATED ORAL 20170515 OTC MONOGRAPH FINAL part341 Topco Associates, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20191231 36800-690_8fdd6ec4-70dd-4588-9a94-7d97dc769e0f 36800-690 HUMAN OTC DRUG Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20130331 OTC MONOGRAPH FINAL part336 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 36800-693_0ec99852-5757-4d64-996e-1f9fc18573a8 36800-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20040709 OTC MONOGRAPH NOT FINAL part334 Topco Assoc LLC MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 36800-699_4d8070d4-ac78-4916-90c9-1ae14b7c5cc2 36800-699 HUMAN OTC DRUG Topcare childrens pain and fever Acetaminophen SUSPENSION ORAL 19970826 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL N 20181231 36800-700_7a4fa966-da33-47df-94a9-893f4938abe9 36800-700 HUMAN OTC DRUG topcare day time Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20060928 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 36800-701_0efcdd06-14fe-4aa7-bebc-cbeef70cf7d1 36800-701 HUMAN OTC DRUG TopCare Cold Max acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20160412 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 36800-703_85b859ca-a480-4787-8d34-10e51159a9da 36800-703 HUMAN OTC DRUG Topcare Cold and Cough Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060309 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 36800-707_3825eca6-51fa-4dd1-bdb4-af65fe9085e3 36800-707 HUMAN OTC DRUG Topco tussin cf max Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20170911 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 36800-715_6ee49834-d78e-49cb-bea8-b03e90468940 36800-715 HUMAN OTC DRUG Childrens Allergy Fexofenadine Hydrochloride SUSPENSION ORAL 20160321 ANDA ANDA203330 Topco Associates LLC FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 36800-717_4d040bac-bda1-4cc2-ae4b-91b9f083c92a 36800-717 HUMAN OTC DRUG TopCare Multi Symptom Severe Cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20160824 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 36800-719_1a4c451e-c0f9-45c9-a878-363e61169765 36800-719 HUMAN OTC DRUG TOPCARE MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20141117 OTC MONOGRAPH FINAL part358H TOPCO ASSOCIATES LLC SELENIUM SULFIDE 10 mg/mL N 20181231 36800-720_4655de57-35e9-4c82-904d-e024ff433565 36800-720 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130530 OTC MONOGRAPH FINAL part336 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 36800-724_71a4c639-174f-4480-91c1-033eb90b85f7 36800-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Topco Associates LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 36800-732_a6711c47-e0cf-4ef1-a16e-606e6522a10e 36800-732 HUMAN OTC DRUG topcare omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate CAPSULE, GELATIN COATED ORAL 20170313 ANDA ANDA201361 Topco Associates LLC OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 N 20181231 36800-733_24daefe4-fc34-45ba-bddd-083ea43c0d77 36800-733 HUMAN OTC DRUG Topcare Nite Time Day Time Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120815 OTC MONOGRAPH FINAL part341 Topco Associates LLC N 20181231 36800-733_41723b37-836b-4aa1-b2a5-156c5b455f57 36800-733 HUMAN OTC DRUG Topcare Nite Time Day Time Cold and Flu Relief acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20111215 OTC MONOGRAPH FINAL part341 Topco Associates LLC N 20181231 36800-734_ba0b72a7-f955-4555-adda-529327f8a9e3 36800-734 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex LOZENGE ORAL 20130215 ANDA ANDA203690 Topco Associates LLC NICOTINE 2 mg/1 N 20181231 36800-735_508bfb00-a32f-4cd0-90b8-7e60929fc511 36800-735 HUMAN OTC DRUG TopCare Mucus DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160720 ANDA ANDA091070 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 36800-737_4c739b4a-262e-4122-a319-31c7e9001f04 36800-737 HUMAN OTC DRUG topcare miconazole 1 Miconazole nitrate KIT 20100615 ANDA ANDA079114 Topco Associates LLC N 20181231 36800-742_8ec10a67-37a6-4364-af2e-f744e4e975cf 36800-742 HUMAN OTC DRUG Topcare Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101123 NDA NDA021920 Topco Associates LLC NAPROXEN SODIUM 220 mg/1 N 20181231 36800-751_865780e0-c30f-47bb-93a9-5608fd6cba9c 36800-751 HUMAN OTC DRUG topcare pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120203 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 36800-759_bff2225e-b9f7-436e-9dd1-57de3652bdd3 36800-759 HUMAN OTC DRUG topcare pain and fever Acetaminophen SUSPENSION ORAL 20100929 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL N 20181231 36800-763_0d4d8a2d-c201-4481-baf2-c4a2ca956802 36800-763 HUMAN OTC DRUG Topcare Nite Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140609 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 36800-766_ed6d3cbd-bd42-4b18-9860-db14a465815e 36800-766 HUMAN OTC DRUG topcare infants pain and fever Acetaminophen SUSPENSION ORAL 20111103 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL N 20181231 36800-768_5df818c4-6e1d-550b-e053-2a91aa0a2d73 36800-768 HUMAN OTC DRUG Effervescent Cold Relief Aspirin, Chlorpheniramine Maleate, Phylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20100701 OTC MONOGRAPH FINAL part341 Topco Associates LLC ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 N 20181231 36800-770_35520fcb-07f8-0d17-e054-00144ff88e88 36800-770 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20160101 OTC MONOGRAPH NOT FINAL part343 TOPCO ASSOCIATES LLC ACETAMINOPHEN 500 mg/1 N 20181231 36800-771_35520fcb-080c-0d17-e054-00144ff88e88 36800-771 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20160101 OTC MONOGRAPH FINAL part341 TOPCO ASSOCIATES LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 36800-777_f769b02d-68b2-4816-a183-a4f1978da47a 36800-777 HUMAN OTC DRUG TOPCARE COUGH COLD AND FLU SIMPLE RELIEF CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20160906 OTC MONOGRAPH FINAL part341 TOPCO ASSOCIATES LLC CHOLINE SALICYLATE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 870; 20; 200; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20191231 36800-781_eaa844e8-85b1-4a7c-bcd7-3188e8123656 36800-781 HUMAN OTC DRUG Allergy Diphenhydramine HCl CAPSULE ORAL 20160715 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 36800-786_cbe80468-565e-42c6-836f-e004b1c1cac0 36800-786 HUMAN OTC DRUG Senna laxative Sennosides TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 TOP CARE (Topco Associates LLC) SENNOSIDES 8.6 mg/1 N 20181231 36800-791_8010fbec-9e4b-4ec3-80dd-cedbf23f1095 36800-791 HUMAN OTC DRUG Topcare Cold and Flu Acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate KIT 20170720 OTC MONOGRAPH FINAL part341 Topco Associates LLC N 20181231 36800-799_5daf3416-ff14-4f20-b808-8f86681cdd88 36800-799 HUMAN OTC DRUG Topcare Tussin DM Max Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20100416 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 36800-800_9d086914-86f6-45f3-8bfa-4bdb00fdc3bf 36800-800 HUMAN OTC DRUG TopCare Nighttime Severe Cold and Cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20140318 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 36800-802_1a65c0d8-e9dd-4c1c-801b-b5a505a4ccc2 36800-802 HUMAN OTC DRUG Topcare Cold and Sore Throat Lemon Flavor Acetaminophen, Pheniramine Maleate, Phenylephrine HCl GRANULE, FOR SOLUTION ORAL 20140520 OTC MONOGRAPH FINAL part341 TOPCARE (Topco Associates LLC) ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 20; 10 mg/1; mg/1; mg/1 N 20181231 36800-803_b3dabd94-b5cd-4134-afb4-aa87c3c33543 36800-803 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20150915 OTC MONOGRAPH FINAL part355 TOPCO ASSOCIATES LLC SODIUM FLUORIDE .2 mg/mL N 20181231 36800-804_ac6b287b-49e7-41f8-a07d-88a1bb59c47d 36800-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19910315 OTC MONOGRAPH NOT FINAL part333A TopCo Assoc LLC ISOPROPYL ALCOHOL .91 mg/mL N 20181231 36800-807_73bc4ab1-cbf4-4894-94a5-d74e85715067 36800-807 HUMAN OTC DRUG Topcare Cold Remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20080904 UNAPPROVED HOMEOPATHIC Topco Associates LLC ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 36800-810_7f722279-022b-49c1-ac65-34bae33b6ecd 36800-810 HUMAN OTC DRUG Sinus and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20140530 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 36800-812_bdf2e24e-fa41-42bb-b21f-aa043d8ee2e9 36800-812 HUMAN OTC DRUG TopCare Sore Throat Honey Lemon Flavor BENZOCAINE, MENTHOL LOZENGE ORAL 20140225 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC BENZOCAINE; MENTHOL 15; 2.6 mg/1; mg/1 N 20181231 36800-813_876982d3-90ec-441e-a0a3-7c29cb235d31 36800-813 HUMAN OTC DRUG TopCare Sore Throat Cherry Flavor BENZOCAINE, MENTHOL LOZENGE ORAL 20140225 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 36800-814_5b21afa7-6806-a755-e053-2991aa0ab890 36800-814 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20130322 OTC MONOGRAPH FINAL part341 Topco Associates MENTHOL 5.4 mg/1 N 20181231 36800-815_5b22145d-40e8-613e-e053-2a91aa0af304 36800-815 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20130320 OTC MONOGRAPH FINAL part341 TopCo Associates MENTHOL 5.8 mg/1 N 20181231 36800-815_5b22145d-40f9-613e-e053-2a91aa0af304 36800-815 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20130320 OTC MONOGRAPH FINAL part341 TopCo Associates MENTHOL 5.8 mg/1 N 20181231 36800-815_5b22145d-4109-613e-e053-2a91aa0af304 36800-815 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20130322 OTC MONOGRAPH FINAL part341 Topco Associates MENTHOL 5.8 mg/1 N 20181231 36800-816_5b21afa7-6873-a755-e053-2991aa0ab890 36800-816 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20130320 OTC MONOGRAPH FINAL part341 Topco Associates MENTHOL 7.5 mg/1 N 20181231 36800-816_5b21afa7-68ed-a755-e053-2991aa0ab890 36800-816 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20130320 OTC MONOGRAPH FINAL part341 Topco Associates MENTHOL 7.5 mg/1 N 20181231 36800-816_5b224f63-099f-4a80-e053-2991aa0aab25 36800-816 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20130322 OTC MONOGRAPH FINAL part341 Topco Associates MENTHOL 7.5 mg/1 N 20181231 36800-817_70d0240d-12ad-4336-bbca-4bfb5c454db5 36800-817 HUMAN OTC DRUG Topcare Nasal oxymetazoline hydrochloride SPRAY NASAL 19960806 OTC MONOGRAPH FINAL part341 Topco Associates LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 36800-818_5b22ceef-4e37-3a9f-e053-2a91aa0adf20 36800-818 HUMAN OTC DRUG strawberry cough drops menthol LOZENGE ORAL 20130322 OTC MONOGRAPH FINAL part341 Topco Associates MENTHOL 2.7 mg/1 N 20181231 36800-819_5b22aa29-482f-ff0b-e053-2a91aa0a4320 36800-819 HUMAN OTC DRUG sugar free menthol cough drops menthol LOZENGE ORAL 20130322 OTC MONOGRAPH FINAL part341 Topco Associates MENTHOL 5.8 mg/1 N 20181231 36800-820_5b23260d-9265-26c0-e053-2a91aa0a1a85 36800-820 HUMAN OTC DRUG sugar free cherry cough drops menthol LOZENGE ORAL 20130322 OTC MONOGRAPH FINAL part341 Topco Associates MENTHOL 5.8 mg/1 N 20181231 36800-821_63e89687-4735-4616-ac71-0598c163bc8b 36800-821 HUMAN OTC DRUG Acne Scrub Salicylic Acid CREAM TOPICAL 20130226 OTC MONOGRAPH FINAL part333D TopCo Associates LLC SALICYLIC ACID 20 mg/mL N 20181231 36800-822_5b234948-3d07-3656-e053-2a91aa0abe24 36800-822 HUMAN OTC DRUG sugar free honey lemon cough drops menthol LOZENGE ORAL 20130322 OTC MONOGRAPH FINAL part341 Topco Associates MENTHOL 7.6 mg/1 N 20181231 36800-823_36848f90-b746-666f-e054-00144ff8d46c 36800-823 HUMAN OTC DRUG berry breezer throat drop pectin LOZENGE ORAL 20130322 OTC MONOGRAPH NOT FINAL part356 Topco Associates PECTIN 7 mg/1 N 20181231 36800-825_267be555-a3f2-4476-acc7-f2e4fe4374b1 36800-825 HUMAN OTC DRUG Topcare Miconazole 7 Miconazole nitrate CREAM VAGINAL 20000229 ANDA ANDA074760 Topco Associates LLC MICONAZOLE NITRATE 2 g/100g N 20181231 36800-826_3682da84-409f-1090-e054-00144ff88e88 36800-826 HUMAN OTC DRUG herbal cough drops menthol LOZENGE ORAL 20160525 OTC MONOGRAPH FINAL part341 Topco Associates MENTHOL 4.8 mg/1 N 20181231 36800-827_3685e6fe-e00d-103b-e054-00144ff88e88 36800-827 HUMAN OTC DRUG grape throat relief lollipop pectin LOZENGE ORAL 20150818 OTC MONOGRAPH NOT FINAL part356 Topco Associates PECTIN 10 mg/1 N 20181231 36800-828_3687839e-15e3-40bb-e054-00144ff88e88 36800-828 HUMAN OTC DRUG assorted fruit antacid flavor chews calcium carbonate TABLET, CHEWABLE ORAL 20150601 OTC MONOGRAPH FINAL part331 Topco Associates CALCIUM CARBONATE 750 mg/1 N 20181231 36800-830_3687040b-417f-67d9-e054-00144ff8d46c 36800-830 HUMAN OTC DRUG cherry antacid soft chew calcium carbonate TABLET, CHEWABLE ORAL 20130626 OTC MONOGRAPH FINAL part331 Topco Associates CALCIUM CARBONATE 1177 mg/1 N 20181231 36800-831_4bbbb948-9edf-2b31-e054-00144ff8d46c 36800-831 HUMAN OTC DRUG cold relief zinc gluconate LOZENGE ORAL 20150724 UNAPPROVED HOMEOPATHIC Topco Associates LLC ZINC GLUCONATE 2 [hp_X]/1 N 20181231 36800-832_60b876e7-c643-5ce8-e053-2a91aa0abd6e 36800-832 HUMAN OTC DRUG Cherry Sore Throat Lozenge Benzocaine LOZENGE ORAL 20171219 OTC MONOGRAPH NOT FINAL part356 TopCo MENTHOL; BENZOCAINE 3.6; 15 mg/1; mg/1 N 20181231 36800-833_60dd2d53-ff7c-12fa-e053-2a91aa0a8a8d 36800-833 HUMAN OTC DRUG Honey Lemon Sore Throat Lozenges Benzocaine LOZENGE ORAL 20171221 OTC MONOGRAPH NOT FINAL part356 TopCo MENTHOL; BENZOCAINE 2.6; 15 mg/1; mg/1 N 20181231 36800-835_593a946b-4cfe-4f45-b754-4d1e63b2fdb1 36800-835 HUMAN OTC DRUG TopCare Earwax Removal Kit CARBAMIDE PEROXIDE LIQUID TOPICAL 20141128 OTC MONOGRAPH FINAL part344 TOPCO ASSOCIATES LLC CARBAMIDE PEROXIDE 65 mg/mL N 20181231 36800-839_84d49679-1313-46ff-ba0f-b2c61999300d 36800-839 HUMAN OTC DRUG topcare childrens mucus relief multi symptom cold dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20140808 OTC MONOGRAPH FINAL part341 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 36800-843_c4847242-a324-45a3-96b0-68345b245b1a 36800-843 HUMAN OTC DRUG topcare hemorrhoidal cooling Phenylephrine HCl, Witch hazel GEL TOPICAL 20101208 OTC MONOGRAPH FINAL part346 Topco Associates LLC PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g N 20181231 36800-844_3086e681-3bb7-4490-91a4-9075dc97710c 36800-844 HUMAN OTC DRUG Awake Maximum Strength Caffeine TABLET, FILM COATED ORAL 19980414 OTC MONOGRAPH FINAL part340 Topco Associates, LLC CAFFEINE 200 mg/1 N 20191231 36800-851_791e39c7-2b76-49c8-a6fe-3407a90932ee 36800-851 HUMAN OTC DRUG Topcare Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20021203 OTC MONOGRAPH FINAL part332 Topco Associates LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 36800-852_a9e0cb6a-d202-4b5a-b936-7f7ac8e7382e 36800-852 HUMAN OTC DRUG Topcare Heartburn Relief 150 Ranitidine TABLET, FILM COATED ORAL 20131008 ANDA ANDA091429 Topco Associates LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 36800-854_10b23347-13b5-428b-b8a7-4eb68e5285e5 36800-854 HUMAN OTC DRUG Topcare nicotine stop smoking aid Nicotine polacrilex GUM, CHEWING ORAL 20100128 ANDA ANDA078546 Topco Associates LLC NICOTINE 4 mg/1 N 20181231 36800-863_f0f79275-c27a-4d35-a79a-53b0905c3761 36800-863 HUMAN OTC DRUG Topcare Nicotine Gum Nicotine polacrilex GUM, CHEWING ORAL 20170213 ANDA ANDA206394 Topco Associates LLC NICOTINE 2 mg/1 N 20181231 36800-864_c97e797b-8149-4eec-82d6-b9de675c5a54 36800-864 HUMAN OTC DRUG 50% Rubbing Isopropyl Alcohol LIQUID TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part333A TopCo Associates ISOPROPYL ALCOHOL 500 mg/mL N 20181231 36800-866_d66fd86e-a8fa-4eed-b76e-45a59a5d45be 36800-866 HUMAN OTC DRUG Topcare Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070905 OTC MONOGRAPH FINAL part358G Topco Associates LLC PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 36800-871_a8320093-68a8-4454-8869-79e3f1dd707d 36800-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333A TOPCO ASSOCIATES HYDROGEN PEROXIDE 30 mg/mL N 20181231 36800-872_28af7e25-7f06-4328-b15a-8702657c4f4f 36800-872 HUMAN OTC DRUG Topcare Nite Time Cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20120717 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 36800-873_28eae9e5-cf69-411f-99c4-a27700cf2ae3 36800-873 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex LOZENGE ORAL 20061227 ANDA ANDA077007 Topco Associates LLC NICOTINE 4 mg/1 N 20181231 36800-875_a2d5a6bd-b75c-499c-9a77-190b706a8d8b 36800-875 HUMAN OTC DRUG Salicylic Acid Astringent LIQUID TOPICAL 20090601 OTC MONOGRAPH FINAL part333D TOPCO ASSOCIATES LLC SALICYLIC ACID 5 mg/mL N 20181231 36800-876_5f8ae9ab-5e35-7a60-e053-2991aa0a9817 36800-876 HUMAN OTC DRUG Tolnafate Tolnaftate Powder Spray AEROSOL, SPRAY TOPICAL 20170522 OTC MONOGRAPH FINAL part333C Topco Associates LLC TOLNAFTATE 1.3 g/130g N 20181231 36800-877_5f8b15ea-d844-b0c6-e053-2991aa0ad286 36800-877 HUMAN OTC DRUG Tolnaftate Tolnaftate Jock Itch Powder Spray Talc Free AEROSOL, SPRAY TOPICAL 20171031 OTC MONOGRAPH FINAL part333C Topco Associates LLC TOLNAFTATE 1.3 g/130g N 20181231 36800-880_39a8483c-f7e4-1643-e054-00144ff8d46c 36800-880 HUMAN OTC DRUG Aspirin 81mg Adult Low Dose ASPIRIN TABLET, DELAYED RELEASE ORAL 20161003 OTC MONOGRAPH NOT FINAL part343 TopCare ASPIRIN 81 mg/1 N 20181231 36800-881_f624d092-9893-4fe8-97a3-ab134741ac6c 36800-881 HUMAN OTC DRUG Topcare Antacid Calcium calcium carbonate TABLET, CHEWABLE ORAL 20160303 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 36800-882_8fc2e78c-2991-4f88-a65f-ce53bbf95df2 36800-882 HUMAN OTC DRUG Topcare Gas Relief Simethicone EMULSION ORAL 20031120 OTC MONOGRAPH FINAL part332 Topco Associates LLC DIMETHICONE 20 mg/.3mL N 20181231 36800-888_9871f8a8-da4a-4b65-8894-31155083b466 36800-888 HUMAN OTC DRUG TopCare Nighttime Cold and Flu Simple Relief Choline Salicylate, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20160906 OTC MONOGRAPH FINAL part341 TOPCO ASSOCIATES LLC CHOLINE SALICYLATE; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 870; 50; 10 mg/mL; mg/mL; mg/mL N 20191231 36800-890_4d61d9e8-dada-4eff-b50c-e016589655a7 36800-890 HUMAN OTC DRUG Cold and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20160713 OTC MONOGRAPH FINAL part341 TOP CARE (Topco Associates LLC) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 36800-892_0d1868b3-b22a-4b65-8249-4dd20f573bf8 36800-892 HUMAN OTC DRUG Topcare Cold Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20150929 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 36800-896_c52a1b5b-3f84-4a4e-ae89-f31113e024cd 36800-896 HUMAN OTC DRUG Topcare Lubricant Eye Polyethylene glycol, Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20130904 OTC MONOGRAPH FINAL part349 Topco Associates LLC POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL N 20181231 36800-897_1b0b4d66-5706-462d-ab0d-28230644d41c 36800-897 HUMAN OTC DRUG topcare ibuprofen Ibuprofen SUSPENSION ORAL 19981231 ANDA ANDA074937 Topco Associates LLC IBUPROFEN 100 mg/5mL N 20181231 36800-898_921600aa-088c-43b5-a8e1-74aab4580759 36800-898 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333A Topco ALCOHOL 616 mg/mL N 20181231 36800-899_65a01786-974b-42ab-964e-4017e72c3095 36800-899 HUMAN OTC DRUG TopCare Cough DM Dextromethorphan polistirex SUSPENSION ORAL 20150730 ANDA ANDA091135 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 36800-903_b8bde0b4-2987-4d9e-986e-7988933439dc 36800-903 HUMAN OTC DRUG Topcare Cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20090724 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20191231 36800-906_e84648d1-cd5b-4bad-8cd6-317c2806a787 36800-906 HUMAN OTC DRUG Topcare Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate SOLUTION ORAL 20060921 OTC MONOGRAPH FINAL part341 Topco Associates LLC PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 36800-907_f1dd78e0-f700-4469-85d6-18cc299e8746 36800-907 HUMAN OTC DRUG Topcare Nasal Oxymetazoline hydrochloride SPRAY NASAL 20160714 OTC MONOGRAPH FINAL part341 Topco Associates LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 36800-908_7805c020-f15f-49d2-9c15-9f37a229e38e 36800-908 HUMAN OTC DRUG TopCare Nite Time Cold and flu acetaminophen, dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20060719 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 36800-913_5693b06a-ad5c-4010-a0f6-e27f215c127f 36800-913 HUMAN OTC DRUG Topcare Childrens Triacting Nightime Cold and Cough Diphenhydramine HCl, Phenylephrine HCl SOLUTION ORAL 20070927 OTC MONOGRAPH FINAL part341 Topco Associates LLC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 36800-915_cc2f7c6c-8629-4eff-94aa-b798b319e47a 36800-915 HUMAN OTC DRUG TopCare Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080229 NDA NDA022032 Topco Associates LLC OMEPRAZOLE 20 mg/1 N 20181231 36800-917_5df591c3-1012-4c62-8ccf-f66ee9d9d598 36800-917 HUMAN OTC DRUG Topcare pain relief extra strength Acetaminophen CAPSULE, COATED ORAL 20110105 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 500 mg/1 N 20181231 36800-918_67c74f7f-a065-439b-9b5b-295ec61ef224 36800-918 HUMAN OTC DRUG Topcare sinus relief pressure and pain Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20140622 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 36800-919_16aa1699-6da0-4b89-8387-4514db20ed9d 36800-919 HUMAN OTC DRUG Topcare Tussin CF Acetaminophen, diphenhydramine HCl, phenylephrine HCl SOLUTION ORAL 20170803 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 36800-920_a2821e77-f815-4222-8a2b-0f812d8d03d1 36800-920 HUMAN OTC DRUG TopCare Pain Relief Cold Nightttime acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20160131 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 36800-922_088b53fd-b7ba-446f-8cc4-6a30614a4937 36800-922 HUMAN OTC DRUG Topcare Mucus Relief Severe Congestion and Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130628 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 36800-929_c0623d1b-b7cb-42f2-b659-d042aba930fc 36800-929 HUMAN OTC DRUG topcare clear time Loratadine TABLET ORAL 20150113 ANDA ANDA076301 Topco Associates LLC LORATADINE 10 mg/1 N 20181231 36800-931_f22aeb12-eb5c-4dad-89f2-8d3e8c59fbf6 36800-931 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 20041222 OTC MONOGRAPH NOT FINAL part334 TopCo Associates MINERAL OIL 999 mg/mL N 20181231 36800-935_cbea429d-1392-4e78-9e21-3d6e8a1e3c6b 36800-935 HUMAN OTC DRUG Topcare Sinus Congestion and Pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20090323 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 36800-936_4ac0aaaa-82b4-40ab-bdcf-c7de04bf057e 36800-936 HUMAN OTC DRUG Topcare Sinus Relief Day Time Night Time Acetaminophen, guaifenesin, diphenhydramine HCl, phenylephrine HCl KIT 20140622 OTC MONOGRAPH FINAL part341 Topco Associates LLC N 20181231 36800-941_b61cacb4-364d-4a19-b2a2-12cbbb4e615d 36800-941 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130801 OTC MONOGRAPH NOT FINAL part356 Topco Associates LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 36800-942_674cf888-0fa4-4a7d-ae02-78ff9838b7db 36800-942 HUMAN OTC DRUG Antibacterial Body Wash Benzalkonium chloride LOTION TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part333A Topco Associates LLC BENZALKONIUM CHLORIDE 1.313 mg/mL N 20181231 36800-944_5e13da07-48cf-40bc-bb11-fd891886cbea 36800-944 HUMAN OTC DRUG topcare hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20111103 OTC MONOGRAPH FINAL part346 Topco Associates LLC GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 36800-946_0bab8c5b-e122-46f1-9dec-34798f180559 36800-946 HUMAN OTC DRUG topcare infants pain and fever Acetaminophen SUSPENSION ORAL 20110824 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL N 20181231 36800-947_bca83186-c60f-46be-a95e-c5a5566c9724 36800-947 HUMAN OTC DRUG Oil Free Acne Wash Salicylic acid 2% LOTION TOPICAL 20090521 OTC MONOGRAPH FINAL part333D Topco Associates, LLC SALICYLIC ACID 20.6 mg/mL N 20181231 36800-949_6b7b2837-fa5f-44b0-b6e9-d04fc2f11559 36800-949 HUMAN OTC DRUG TopCare Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20060220 OTC MONOGRAPH NOT FINAL part334 Topco Associates LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 36800-950_47e81312-55f1-4bcd-9fb9-eebb7a225b15 36800-950 HUMAN OTC DRUG topcare heartburn relief 150 Ranitidine TABLET, FILM COATED ORAL 20111010 ANDA ANDA091429 Topco Associates LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 36800-951_59f5611c-a0cc-488b-974e-b7824ec17e47 36800-951 HUMAN OTC DRUG TopCare Mucus Relief and Cold and Flu Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, diphenhydramine HCl KIT 20140624 OTC MONOGRAPH FINAL part341 Topco Associates LLC N 20181231 36800-952_5ae25b15-c0dc-47e4-8608-a4b5fe76a4d3 36800-952 HUMAN OTC DRUG Castor Oil Castor Oil LIQUID ORAL 19910915 OTC MONOGRAPH NOT FINAL part334 TOPCO Associates LLC CASTOR OIL 1 g/mL N 20181231 36800-955_b6a41d07-8b83-4c3f-9536-257791ea3992 36800-955 HUMAN OTC DRUG topcare lice treatment Permethrin LOTION TOPICAL 20110914 ANDA ANDA076090 Topco Associates LLC PERMETHRIN 1 mg/100mL N 20181231 36800-957_1135c667-8691-4136-b7a6-6337345ce4fb 36800-957 HUMAN OTC DRUG Topcare Nicotine Nicotine Polacrilex LOZENGE ORAL 20130214 ANDA ANDA203690 Topco Associates LLC NICOTINE 4 mg/1 N 20181231 36800-958_b2527e11-c3a9-468c-a192-3d49338a4489 36800-958 HUMAN OTC DRUG TopCare Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130822 ANDA ANDA091135 Topco Associates LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 36800-959_f2709867-ffad-4154-8220-f8aa0f1c089e 36800-959 HUMAN OTC DRUG topcare childrens pain and fever Acetaminophen SUSPENSION ORAL 20120227 OTC MONOGRAPH NOT FINAL part343 Topco Associates LLC ACETAMINOPHEN 160 mg/5mL N 20181231 36800-962_1722e68b-9e57-4bcd-9baa-19453c83497e 36800-962 HUMAN OTC DRUG Topcare antacid calcium Calcium carbonate TABLET, CHEWABLE ORAL 20160303 OTC MONOGRAPH FINAL part331 Topco Associates LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 36800-964_8005758f-600c-4225-9a3e-a57152dd2cf2 36800-964 HUMAN OTC DRUG topcare flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20120910 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 36800-970_9fed1b78-60ce-49d3-b522-1846f5e99ddf 36800-970 HUMAN OTC DRUG Allergy Diphenhydramine HCl CAPSULE ORAL 20131130 OTC MONOGRAPH FINAL part336 TOP CARE (Topco Associates LLC) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 36800-971_ca197fec-522c-42e3-a8ee-6bb291b06b2c 36800-971 HUMAN OTC DRUG Anticavity Sodium Fluoride RINSE ORAL 20130919 OTC MONOGRAPH FINAL part355 TOPCO Associates LLC SODIUM FLUORIDE .02 mg/mL N 20181231 36800-979_c554d25d-a7b6-4802-bd1b-9732beb964a7 36800-979 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Pamabrom, Pyrilamine maleate TABLET, FILM COATED ORAL 20150113 OTC MONOGRAPH NOT FINAL part343 Topco Associates, LLC PAMABROM; ACETAMINOPHEN; PYRILAMINE MALEATE 25; 500; 15 mg/1; mg/1; mg/1 N 20191231 36800-982_b76b5ba1-d24b-41c2-a86a-6f748ebc8aaf 36800-982 HUMAN OTC DRUG topcare miconazole 3 combination pack Miconazole nitrate KIT 20041117 ANDA ANDA076357 Topco Associates LLC N 20181231 36800-983_2beb8d46-d372-491a-829a-23e9380c30bb 36800-983 HUMAN OTC DRUG Tri-Buffered Aspirin Regular Strength Aspirin TABLET, FILM COATED ORAL 19900330 OTC MONOGRAPH NOT FINAL part343 Topco Associates, LLC ASPIRIN 325 mg/1 N 20191231 36800-985_929b7b73-bb43-4b2e-9894-7e2b29b94c93 36800-985 HUMAN OTC DRUG Allergy Plus Congestion Diphenhydramine HCl, Phenylephrine HCl TABLET, FILM COATED ORAL 20050810 OTC MONOGRAPH FINAL part341 Topco Associates, LLC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 25; 10 mg/1; mg/1 N 20191231 36800-987_9d8ff768-f849-4362-9a84-d40f539f1c4f 36800-987 HUMAN OTC DRUG Topcare childrens cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20060929 OTC MONOGRAPH FINAL part341 Topco Associates LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 36800-993_a2c2298d-de6f-46a9-b21f-919fc5b1dd59 36800-993 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Topco Associates, LLC IBUPROFEN 200 mg/1 N 20191231 36800-997_b439fe3f-0798-47c4-a2f1-62761189bb45 36800-997 HUMAN OTC DRUG Topcare Sinus Relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20140622 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 36800-999_2a7dc9bc-c855-1f23-e054-00144ff8d46c 36800-999 HUMAN OTC DRUG mixed berry throat lozenge benzocaine, dextromethorhan hydrobromide LOZENGE ORAL 20150803 OTC MONOGRAPH NOT FINAL part356 Topco BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20181231 36800-999_3e94664a-6232-4f5c-94d0-9d0c09e3164b 36800-999 HUMAN OTC DRUG topcare cold and flu night time Acetaminophen, diphenhydramine HCl, phenylephrine HCl TABLET, FILM COATED ORAL 20140624 OTC MONOGRAPH FINAL part341 Topco Associates LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 36987-1001_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1001 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1002_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1002 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1003_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1003 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1004_b8207809-3a22-4e67-8783-87f426677ccf 36987-1004 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1005_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1005 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1006_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1006 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1007_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1007 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1008_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1008 HUMAN PRESCRIPTION DRUG Cattle Epithelium Cattle Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOS TAURUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1009_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1009 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1010_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1010 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1011_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1011 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1012_b8207809-3a22-4e67-8783-87f426677ccf 36987-1012 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1013_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1013 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1014_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1014 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1015_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1015 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1016_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1016 HUMAN PRESCRIPTION DRUG Dog Epithelium Dog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANIS LUPUS FAMILIARIS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1017_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1017 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER 10000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1018_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1018 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER 10000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1019_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1019 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER 20000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1020_b8207809-3a22-4e67-8783-87f426677ccf 36987-1020 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER 20000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1021_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1021 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1022_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1022 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1023_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1023 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER .1 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1024_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1024 HUMAN PRESCRIPTION DRUG Chicken Feathers Chicken Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GALLUS GALLUS FEATHER .1 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1025_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1025 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER 10000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1026_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1026 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER 10000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1027_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1027 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER 20000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1028_b8207809-3a22-4e67-8783-87f426677ccf 36987-1028 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER 20000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1029_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1029 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1030_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1030 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1031_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1031 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER .1 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1032_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1032 HUMAN PRESCRIPTION DRUG Duck Feathers Duck Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER .1 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1033_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1033 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER 10000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1034_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1034 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER 10000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1035_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1035 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER 20000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1036_b8207809-3a22-4e67-8783-87f426677ccf 36987-1036 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER 20000 [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1037_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1037 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1038_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1038 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1039_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1039 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER .1 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1040_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1040 HUMAN PRESCRIPTION DRUG Goose Feathers Goose Feathers INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ANSER ANSER FEATHER .1 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 36987-1041_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1041 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1042_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1042 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1043_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1043 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1044_b8207809-3a22-4e67-8783-87f426677ccf 36987-1044 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1045_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1045 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1046_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1046 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1047_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1047 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1048_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1048 HUMAN PRESCRIPTION DRUG Gerbil Epithelium Gerbil Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MERIONES UNGUICULATUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1049_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1049 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1050_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1050 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1051_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1051 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1052_b8207809-3a22-4e67-8783-87f426677ccf 36987-1052 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1053_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1053 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1054_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1054 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1055_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1055 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1056_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1056 HUMAN PRESCRIPTION DRUG Goat Epithelium Goat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAPRA HIRCUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1057_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1057 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1058_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1058 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1059_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1059 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1060_b8207809-3a22-4e67-8783-87f426677ccf 36987-1060 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1061_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1061 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1062_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1062 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1063_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1063 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1064_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1064 HUMAN PRESCRIPTION DRUG Guinea Pig Epithelium Guinea Pig Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAVIA PORCELLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1065_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1065 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1066_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1066 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1067_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1067 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1068_b8207809-3a22-4e67-8783-87f426677ccf 36987-1068 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1069_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1069 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1070_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1070 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1071_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1071 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1072_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1072 HUMAN PRESCRIPTION DRUG Hamster Epithelium Hamster Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MESOCRICETUS AURATUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1073_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1073 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1074_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1074 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1075_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1075 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1076_b8207809-3a22-4e67-8783-87f426677ccf 36987-1076 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1077_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1077 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1078_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1078 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1079_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1079 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1080_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1080 HUMAN PRESCRIPTION DRUG Hog Epithelium Hog Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SUS SCROFA SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1081_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1081 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1082_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1082 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1083_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1083 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1084_b8207809-3a22-4e67-8783-87f426677ccf 36987-1084 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1085_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1085 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1086_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1086 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1087_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1087 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1088_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1088 HUMAN PRESCRIPTION DRUG Horse Epithelium Horse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EQUUS CABALLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1089_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1089 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1090_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1090 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1091_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1091 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1092_b8207809-3a22-4e67-8783-87f426677ccf 36987-1092 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1093_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1093 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1094_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1094 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1095_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1095 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1096_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1096 HUMAN PRESCRIPTION DRUG Mouse Epithelium Mouse Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUS MUSCULUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1097_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1097 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1098_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1098 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1099_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1099 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1100_b8207809-3a22-4e67-8783-87f426677ccf 36987-1100 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1101_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1101 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1102_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1102 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1103_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1103 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1104_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1104 HUMAN PRESCRIPTION DRUG Rabbit Epithelium Rabbit Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORYCTOLAGUS CUNICULUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1105_b0fc4197-0bdb-4abe-a7ed-def8313f50c9 36987-1105 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1106_391e0cff-b4e3-4e38-bbd8-2f9479d6998e 36987-1106 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN 10000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1107_8f2b01b8-e712-4107-b824-e1f07faa2a41 36987-1107 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1108_b8207809-3a22-4e67-8783-87f426677ccf 36987-1108 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN 20000 [PNU]/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1109_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1109 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1110_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1110 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1111_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1111 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1112_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1112 HUMAN PRESCRIPTION DRUG Rat Epithelium Rat Epithelium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RATTUS NORVEGICUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1117_d286f05f-7a27-4572-85e2-656e08fd70a2 36987-1117 HUMAN PRESCRIPTION DRUG Silk Silk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOMBYX MORI FIBER .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Silk [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1118_d877e2c0-e17b-4d3e-ba6a-c2a3cd27e025 36987-1118 HUMAN PRESCRIPTION DRUG Silk Silk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOMBYX MORI FIBER .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Silk [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1119_9cd5b8c5-a866-4089-90e5-a0ad15736698 36987-1119 HUMAN PRESCRIPTION DRUG Silk Silk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOMBYX MORI FIBER .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Silk [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1120_1689799a-e4a1-4882-859e-be9c4e31d6ee 36987-1120 HUMAN PRESCRIPTION DRUG Silk Silk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOMBYX MORI FIBER .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Silk [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1121_2493858b-a2cf-4002-9c34-c7ed847be36c 36987-1121 HUMAN PRESCRIPTION DRUG Standardized Cat Hair Standardized Cat Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920929 BLA BLA103384 Nelco Laboratories, Inc. FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] E 20171231 36987-1122_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1122 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST 10000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] E 20171231 36987-1123_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1123 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST 10000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] E 20171231 36987-1124_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1124 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST 20000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] E 20171231 36987-1125_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1125 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST 20000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] E 20171231 36987-1126_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1126 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST 40000 [PNU]/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] E 20171231 36987-1127_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1127 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST .05 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] E 20171231 36987-1128_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1128 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST .05 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] E 20171231 36987-1129_0dacbc5b-587a-4c20-ad07-45caf841a3ba 36987-1129 HUMAN PRESCRIPTION DRUG House Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOUSE DUST .1 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] E 20171231 36987-1130_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1130 HUMAN PRESCRIPTION DRUG Egg White Egg White INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG WHITE .05 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 36987-1131_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1131 HUMAN PRESCRIPTION DRUG Egg White Egg White INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG WHITE .05 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 36987-1132_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1132 HUMAN PRESCRIPTION DRUG Egg White Egg White INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG WHITE .1 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 36987-1133_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1133 HUMAN PRESCRIPTION DRUG Egg White Egg White INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG WHITE .1 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 36987-1134_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1134 HUMAN PRESCRIPTION DRUG Egg Yolk Egg Yolk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG YOLK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1135_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1135 HUMAN PRESCRIPTION DRUG Egg Yolk Egg Yolk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG YOLK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1136_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1136 HUMAN PRESCRIPTION DRUG Egg Yolk Egg Yolk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG YOLK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1137_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1137 HUMAN PRESCRIPTION DRUG Egg Yolk Egg Yolk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG YOLK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1138_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1138 HUMAN PRESCRIPTION DRUG Whole Egg Whole Egg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1139_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1139 HUMAN PRESCRIPTION DRUG Whole Egg Whole Egg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1140_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1140 HUMAN PRESCRIPTION DRUG Whole Egg Whole Egg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1141_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1141 HUMAN PRESCRIPTION DRUG Whole Egg Whole Egg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGG .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1142_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1142 HUMAN PRESCRIPTION DRUG Beef Beef INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEEF .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1143_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1143 HUMAN PRESCRIPTION DRUG Beef Beef INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEEF .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1144_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1144 HUMAN PRESCRIPTION DRUG Beef Beef INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEEF .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1145_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1145 HUMAN PRESCRIPTION DRUG Beef Beef INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEEF .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1146_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1146 HUMAN PRESCRIPTION DRUG Chicken Meat Chicken Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKEN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 36987-1147_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1147 HUMAN PRESCRIPTION DRUG Chicken Meat Chicken Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKEN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 36987-1148_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1148 HUMAN PRESCRIPTION DRUG Chicken Meat Chicken Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKEN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 36987-1149_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1149 HUMAN PRESCRIPTION DRUG Chicken Meat Chicken Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKEN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 36987-1150_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1150 HUMAN PRESCRIPTION DRUG Duck Meat Duck Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DUCK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 36987-1151_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1151 HUMAN PRESCRIPTION DRUG Duck Meat Duck Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DUCK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 36987-1152_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1152 HUMAN PRESCRIPTION DRUG Duck Meat Duck Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DUCK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 36987-1153_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1153 HUMAN PRESCRIPTION DRUG Duck Meat Duck Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DUCK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 36987-1154_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1154 HUMAN PRESCRIPTION DRUG Lamb Lamb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAMB .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1155_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1155 HUMAN PRESCRIPTION DRUG Lamb Lamb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAMB .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1156_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1156 HUMAN PRESCRIPTION DRUG Lamb Lamb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAMB .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1157_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1157 HUMAN PRESCRIPTION DRUG Lamb Lamb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAMB .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1158_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1158 HUMAN PRESCRIPTION DRUG Beef Liver Beef Liver INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- BEEF LIVER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1159_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1159 HUMAN PRESCRIPTION DRUG Beef Liver Beef Liver INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- BEEF LIVER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1160_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1160 HUMAN PRESCRIPTION DRUG Beef Liver Beef Liver INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- BEEF LIVER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1161_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1161 HUMAN PRESCRIPTION DRUG Beef Liver Beef Liver INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- BEEF LIVER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1162_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1162 HUMAN PRESCRIPTION DRUG Pork Pork INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PORK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1163_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1163 HUMAN PRESCRIPTION DRUG Pork Pork INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PORK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1164_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1164 HUMAN PRESCRIPTION DRUG Pork Pork INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PORK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1165_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1165 HUMAN PRESCRIPTION DRUG Pork Pork INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PORK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1166_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1166 HUMAN PRESCRIPTION DRUG Turkey Turkey INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURKEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 36987-1167_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1167 HUMAN PRESCRIPTION DRUG Turkey Turkey INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURKEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 36987-1168_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1168 HUMAN PRESCRIPTION DRUG Turkey Turkey INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURKEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 36987-1169_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1169 HUMAN PRESCRIPTION DRUG Turkey Turkey INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURKEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 36987-1170_c47721d9-cc1e-4d29-a834-7a2734bbfa0e 36987-1170 HUMAN PRESCRIPTION DRUG Veal Veal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VEAL .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1171_3b83affb-08b1-4a52-98de-4fdc957b4be2 36987-1171 HUMAN PRESCRIPTION DRUG Veal Veal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VEAL .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1172_9260de65-5d7a-40ad-b190-f4e2996a2726 36987-1172 HUMAN PRESCRIPTION DRUG Veal Veal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VEAL .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1173_c90dcd7d-3160-43f0-9143-81ae26ec08f7 36987-1173 HUMAN PRESCRIPTION DRUG Veal Veal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VEAL .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 36987-1174_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1174 HUMAN PRESCRIPTION DRUG Casein Casein INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASEIN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] E 20171231 36987-1175_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1175 HUMAN PRESCRIPTION DRUG Casein Casein INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASEIN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] E 20171231 36987-1176_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1176 HUMAN PRESCRIPTION DRUG Casein Casein INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASEIN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] E 20171231 36987-1177_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1177 HUMAN PRESCRIPTION DRUG Casein Casein INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASEIN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] E 20171231 36987-1178_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1178 HUMAN PRESCRIPTION DRUG Cows Milk Cows Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COW MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] E 20171231 36987-1179_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1179 HUMAN PRESCRIPTION DRUG Cows Milk Cows Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COW MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] E 20171231 36987-1180_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1180 HUMAN PRESCRIPTION DRUG Cows Milk Cows Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COW MILK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] E 20171231 36987-1181_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1181 HUMAN PRESCRIPTION DRUG Cows Milk Cows Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COW MILK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] E 20171231 36987-1182_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1182 HUMAN PRESCRIPTION DRUG Goats Milk Goats Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GOAT MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] E 20171231 36987-1183_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1183 HUMAN PRESCRIPTION DRUG Goats Milk Goats Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GOAT MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] E 20171231 36987-1184_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1184 HUMAN PRESCRIPTION DRUG Goats Milk Goats Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GOAT MILK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] E 20171231 36987-1185_aa2e628b-4152-4987-b71f-554c48bf701a 36987-1185 HUMAN PRESCRIPTION DRUG Goats Milk Goats Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GOAT MILK .01 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] E 20171231 36987-1190_efd0d48e-a918-47ac-8a38-6bd92970e678 36987-1190 HUMAN PRESCRIPTION DRUG Bluefish Bluefish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1191_f5674b12-782b-4941-a56a-72e592cbddc4 36987-1191 HUMAN PRESCRIPTION DRUG Bluefish Bluefish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1192_3565cc6a-3d3e-4561-9faa-61899993b0b3 36987-1192 HUMAN PRESCRIPTION DRUG Bluefish Bluefish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1193_3483052b-e8ac-47fc-aa09-c1058d243ce2 36987-1193 HUMAN PRESCRIPTION DRUG Bluefish Bluefish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1194_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1194 HUMAN PRESCRIPTION DRUG Carp Carp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COMMON CARP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1195_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1195 HUMAN PRESCRIPTION DRUG Carp Carp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COMMON CARP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1196_2266ee8c-c745-471e-845a-267f11a1c269 36987-1196 HUMAN PRESCRIPTION DRUG Carp Carp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COMMON CARP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1197_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1197 HUMAN PRESCRIPTION DRUG Carp Carp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COMMON CARP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1198_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1198 HUMAN PRESCRIPTION DRUG Clam Clam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLAM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1199_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1199 HUMAN PRESCRIPTION DRUG Clam Clam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLAM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1200_2266ee8c-c745-471e-845a-267f11a1c269 36987-1200 HUMAN PRESCRIPTION DRUG Clam Clam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLAM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1201_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1201 HUMAN PRESCRIPTION DRUG Clam Clam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLAM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1202_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1202 HUMAN PRESCRIPTION DRUG Codfish Codfish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CODFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1203_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1203 HUMAN PRESCRIPTION DRUG Codfish Codfish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CODFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1204_2266ee8c-c745-471e-845a-267f11a1c269 36987-1204 HUMAN PRESCRIPTION DRUG Codfish Codfish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CODFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1205_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1205 HUMAN PRESCRIPTION DRUG Codfish Codfish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CODFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1206_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1206 HUMAN PRESCRIPTION DRUG Crab Crab INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRAB .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1207_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1207 HUMAN PRESCRIPTION DRUG Crab Crab INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRAB .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1208_2266ee8c-c745-471e-845a-267f11a1c269 36987-1208 HUMAN PRESCRIPTION DRUG Crab Crab INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRAB .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1209_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1209 HUMAN PRESCRIPTION DRUG Crab Crab INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRAB .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1210_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1210 HUMAN PRESCRIPTION DRUG Flounder Flounder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLOUNDER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1211_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1211 HUMAN PRESCRIPTION DRUG Flounder Flounder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLOUNDER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1212_2266ee8c-c745-471e-845a-267f11a1c269 36987-1212 HUMAN PRESCRIPTION DRUG Flounder Flounder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLOUNDER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1213_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1213 HUMAN PRESCRIPTION DRUG Flounder Flounder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLOUNDER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1214_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1214 HUMAN PRESCRIPTION DRUG Haddock Haddock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HADDOCK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1215_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1215 HUMAN PRESCRIPTION DRUG Haddock Haddock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HADDOCK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1216_2266ee8c-c745-471e-845a-267f11a1c269 36987-1216 HUMAN PRESCRIPTION DRUG Haddock Haddock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HADDOCK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1217_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1217 HUMAN PRESCRIPTION DRUG Haddock Haddock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HADDOCK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1218_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1218 HUMAN PRESCRIPTION DRUG Halibut Halibut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PACIFIC HALIBUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1219_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1219 HUMAN PRESCRIPTION DRUG Halibut Halibut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PACIFIC HALIBUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1220_2266ee8c-c745-471e-845a-267f11a1c269 36987-1220 HUMAN PRESCRIPTION DRUG Halibut Halibut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PACIFIC HALIBUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1221_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1221 HUMAN PRESCRIPTION DRUG Halibut Halibut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PACIFIC HALIBUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1222_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1222 HUMAN PRESCRIPTION DRUG Herring Herring INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HERRING .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1223_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1223 HUMAN PRESCRIPTION DRUG Herring Herring INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HERRING .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1224_2266ee8c-c745-471e-845a-267f11a1c269 36987-1224 HUMAN PRESCRIPTION DRUG Herring Herring INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HERRING .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1225_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1225 HUMAN PRESCRIPTION DRUG Herring Herring INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HERRING .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1226_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1226 HUMAN PRESCRIPTION DRUG Lobster Lobster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOBSTER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1227_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1227 HUMAN PRESCRIPTION DRUG Lobster Lobster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOBSTER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1228_2266ee8c-c745-471e-845a-267f11a1c269 36987-1228 HUMAN PRESCRIPTION DRUG Lobster Lobster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOBSTER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1229_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1229 HUMAN PRESCRIPTION DRUG Lobster Lobster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOBSTER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1230_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1230 HUMAN PRESCRIPTION DRUG Mackerel Mackerel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACKEREL .05 g/mL E 20171231 36987-1231_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1231 HUMAN PRESCRIPTION DRUG Mackerel Mackerel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACKEREL .05 g/mL E 20171231 36987-1232_2266ee8c-c745-471e-845a-267f11a1c269 36987-1232 HUMAN PRESCRIPTION DRUG Mackerel Mackerel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACKEREL .1 g/mL E 20171231 36987-1233_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1233 HUMAN PRESCRIPTION DRUG Mackerel Mackerel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACKEREL .1 g/mL E 20171231 36987-1234_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1234 HUMAN PRESCRIPTION DRUG Oyster Oyster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OYSTER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1235_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1235 HUMAN PRESCRIPTION DRUG Oyster Oyster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OYSTER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1236_2266ee8c-c745-471e-845a-267f11a1c269 36987-1236 HUMAN PRESCRIPTION DRUG Oyster Oyster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OYSTER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1237_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1237 HUMAN PRESCRIPTION DRUG Oyster Oyster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OYSTER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1238_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1238 HUMAN PRESCRIPTION DRUG Pike Pike INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NORTHERN PIKE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1239_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1239 HUMAN PRESCRIPTION DRUG Pike Pike INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NORTHERN PIKE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1240_2266ee8c-c745-471e-845a-267f11a1c269 36987-1240 HUMAN PRESCRIPTION DRUG Pike Pike INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NORTHERN PIKE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1241_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1241 HUMAN PRESCRIPTION DRUG Pike Pike INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NORTHERN PIKE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1242_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1242 HUMAN PRESCRIPTION DRUG Red Snapper Red Snapper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RED SNAPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1243_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1243 HUMAN PRESCRIPTION DRUG Red Snapper Red Snapper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RED SNAPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1244_2266ee8c-c745-471e-845a-267f11a1c269 36987-1244 HUMAN PRESCRIPTION DRUG Red Snapper Red Snapper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RED SNAPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1245_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1245 HUMAN PRESCRIPTION DRUG Red Snapper Red Snapper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RED SNAPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1246_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1246 HUMAN PRESCRIPTION DRUG Salmon Salmon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATLANTIC SALMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1247_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1247 HUMAN PRESCRIPTION DRUG Salmon Salmon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATLANTIC SALMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1248_2266ee8c-c745-471e-845a-267f11a1c269 36987-1248 HUMAN PRESCRIPTION DRUG Salmon Salmon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATLANTIC SALMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1249_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1249 HUMAN PRESCRIPTION DRUG Salmon Salmon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATLANTIC SALMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1250_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1250 HUMAN PRESCRIPTION DRUG Sardine Sardine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROPEAN PILCHARD .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1251_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1251 HUMAN PRESCRIPTION DRUG Sardine Sardine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROPEAN PILCHARD .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1252_2266ee8c-c745-471e-845a-267f11a1c269 36987-1252 HUMAN PRESCRIPTION DRUG Sardine Sardine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROPEAN PILCHARD .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1253_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1253 HUMAN PRESCRIPTION DRUG Sardine Sardine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROPEAN PILCHARD .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1254_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1254 HUMAN PRESCRIPTION DRUG Scallop Scallop INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SCALLOP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1255_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1255 HUMAN PRESCRIPTION DRUG Scallop Scallop INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SCALLOP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1256_2266ee8c-c745-471e-845a-267f11a1c269 36987-1256 HUMAN PRESCRIPTION DRUG Scallop Scallop INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SCALLOP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1257_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1257 HUMAN PRESCRIPTION DRUG Scallop Scallop INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SCALLOP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1258_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1258 HUMAN PRESCRIPTION DRUG Shrimp Shrimp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SHRIMP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1259_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1259 HUMAN PRESCRIPTION DRUG Shrimp Shrimp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SHRIMP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1260_2266ee8c-c745-471e-845a-267f11a1c269 36987-1260 HUMAN PRESCRIPTION DRUG Shrimp Shrimp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SHRIMP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1261_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1261 HUMAN PRESCRIPTION DRUG Shrimp Shrimp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SHRIMP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 36987-1262_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1262 HUMAN PRESCRIPTION DRUG Smelt Smelt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SMELT .05 g/mL E 20171231 36987-1263_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1263 HUMAN PRESCRIPTION DRUG Smelt Smelt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SMELT .05 g/mL E 20171231 36987-1264_2266ee8c-c745-471e-845a-267f11a1c269 36987-1264 HUMAN PRESCRIPTION DRUG Smelt Smelt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SMELT .1 g/mL E 20171231 36987-1265_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1265 HUMAN PRESCRIPTION DRUG Smelt Smelt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SMELT .1 g/mL E 20171231 36987-1266_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1266 HUMAN PRESCRIPTION DRUG Sword Fish Sword Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWORDFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1267_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1267 HUMAN PRESCRIPTION DRUG Sword Fish Sword Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWORDFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1268_2266ee8c-c745-471e-845a-267f11a1c269 36987-1268 HUMAN PRESCRIPTION DRUG Sword Fish Sword Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWORDFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1269_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1269 HUMAN PRESCRIPTION DRUG Sword Fish Sword Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWORDFISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1270_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1270 HUMAN PRESCRIPTION DRUG Trout Trout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TROUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1271_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1271 HUMAN PRESCRIPTION DRUG Trout Trout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TROUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1272_2266ee8c-c745-471e-845a-267f11a1c269 36987-1272 HUMAN PRESCRIPTION DRUG Trout Trout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TROUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1273_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1273 HUMAN PRESCRIPTION DRUG Trout Trout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TROUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1274_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1274 HUMAN PRESCRIPTION DRUG Tuna Fish Tuna Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TUNA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1275_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1275 HUMAN PRESCRIPTION DRUG Tuna Fish Tuna Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TUNA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1276_2266ee8c-c745-471e-845a-267f11a1c269 36987-1276 HUMAN PRESCRIPTION DRUG Tuna Fish Tuna Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TUNA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1277_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1277 HUMAN PRESCRIPTION DRUG Tuna Fish Tuna Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TUNA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1278_7c6e2716-24f3-4479-abfc-901a69fc08d9 36987-1278 HUMAN PRESCRIPTION DRUG White Fish White Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE FISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1279_fb3d0fab-7ff8-4dc3-bbdd-937e9a9f50e4 36987-1279 HUMAN PRESCRIPTION DRUG White Fish White Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE FISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1280_2266ee8c-c745-471e-845a-267f11a1c269 36987-1280 HUMAN PRESCRIPTION DRUG White Fish White Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE FISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1281_398aea37-e253-4fd4-84ca-ca78367468b5 36987-1281 HUMAN PRESCRIPTION DRUG White Fish White Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE FISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 36987-1282_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1282 HUMAN PRESCRIPTION DRUG Red Delicious Apple Red Delicious Apple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APPLE .05 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1283_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1283 HUMAN PRESCRIPTION DRUG Red Delicious Apple Red Delicious Apple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APPLE .05 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1284_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1284 HUMAN PRESCRIPTION DRUG Red Delicious Apple Red Delicious Apple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APPLE .1 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1285_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1285 HUMAN PRESCRIPTION DRUG Red Delicious Apple Red Delicious Apple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APPLE .1 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1286_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1286 HUMAN PRESCRIPTION DRUG Apricot Apricot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APRICOT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1287_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1287 HUMAN PRESCRIPTION DRUG Apricot Apricot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APRICOT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1288_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1288 HUMAN PRESCRIPTION DRUG Apricot Apricot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APRICOT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1289_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1289 HUMAN PRESCRIPTION DRUG Apricot Apricot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. APRICOT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1290_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1290 HUMAN PRESCRIPTION DRUG Avocado Avocado INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVOCADO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1291_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1291 HUMAN PRESCRIPTION DRUG Avocado Avocado INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVOCADO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1292_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1292 HUMAN PRESCRIPTION DRUG Avocado Avocado INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVOCADO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1293_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1293 HUMAN PRESCRIPTION DRUG Avocado Avocado INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVOCADO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1294_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1294 HUMAN PRESCRIPTION DRUG Banana Banana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BANANA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1295_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1295 HUMAN PRESCRIPTION DRUG Banana Banana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BANANA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1296_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1296 HUMAN PRESCRIPTION DRUG Banana Banana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BANANA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1297_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1297 HUMAN PRESCRIPTION DRUG Banana Banana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BANANA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1298_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1298 HUMAN PRESCRIPTION DRUG Blackberry Blackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACKBERRY .05 g/mL E 20171231 36987-1299_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1299 HUMAN PRESCRIPTION DRUG Blackberry Blackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACKBERRY .05 g/mL E 20171231 36987-1300_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1300 HUMAN PRESCRIPTION DRUG Blackberry Blackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACKBERRY .1 g/mL E 20171231 36987-1301_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1301 HUMAN PRESCRIPTION DRUG Blackberry Blackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACKBERRY .1 g/mL E 20171231 36987-1302_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1302 HUMAN PRESCRIPTION DRUG Blueberry Blueberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEBERRY .05 g/mL E 20171231 36987-1303_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1303 HUMAN PRESCRIPTION DRUG Blueberry Blueberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEBERRY .05 g/mL E 20171231 36987-1304_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1304 HUMAN PRESCRIPTION DRUG Blueberry Blueberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEBERRY .1 g/mL E 20171231 36987-1305_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1305 HUMAN PRESCRIPTION DRUG Blueberry Blueberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLUEBERRY .1 g/mL E 20171231 36987-1306_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1306 HUMAN PRESCRIPTION DRUG Cantaloupe Cantaloupe INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANTALOUPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1307_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1307 HUMAN PRESCRIPTION DRUG Cantaloupe Cantaloupe INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANTALOUPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1308_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1308 HUMAN PRESCRIPTION DRUG Cantaloupe Cantaloupe INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANTALOUPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1309_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1309 HUMAN PRESCRIPTION DRUG Cantaloupe Cantaloupe INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANTALOUPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1310_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1310 HUMAN PRESCRIPTION DRUG Cherry Bing Cherry Bing INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOUR CHERRY .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1311_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1311 HUMAN PRESCRIPTION DRUG Cherry Bing Cherry Bing INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOUR CHERRY .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1312_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1312 HUMAN PRESCRIPTION DRUG Cherry Bing Cherry Bing INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOUR CHERRY .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1313_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1313 HUMAN PRESCRIPTION DRUG Cherry Bing Cherry Bing INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOUR CHERRY .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1314_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1314 HUMAN PRESCRIPTION DRUG Cranberry Cranberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRANBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1315_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1315 HUMAN PRESCRIPTION DRUG Cranberry Cranberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRANBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1316_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1316 HUMAN PRESCRIPTION DRUG Cranberry Cranberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRANBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1317_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1317 HUMAN PRESCRIPTION DRUG Cranberry Cranberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CRANBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1318_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1318 HUMAN PRESCRIPTION DRUG Date Date INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DATE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1319_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1319 HUMAN PRESCRIPTION DRUG Date Date INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DATE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1320_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1320 HUMAN PRESCRIPTION DRUG Date Date INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DATE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1321_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1321 HUMAN PRESCRIPTION DRUG Date Date INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DATE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1322_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1322 HUMAN PRESCRIPTION DRUG Fig Fig INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FIG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1323_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1323 HUMAN PRESCRIPTION DRUG Fig Fig INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FIG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1324_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1324 HUMAN PRESCRIPTION DRUG Fig Fig INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FIG .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1325_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1325 HUMAN PRESCRIPTION DRUG Fig Fig INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FIG .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1326_5d401ba5-12ed-4caf-b4bd-ef67706de2e7 36987-1326 HUMAN PRESCRIPTION DRUG Thompson Seedless Grape Thompson Seedless Grape INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WINE GRAPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1327_4b0b81c8-afbe-4531-82ab-623d63b0795f 36987-1327 HUMAN PRESCRIPTION DRUG Thompson Seedless Grape Thompson Seedless Grape INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WINE GRAPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1328_4bc24d90-8765-49c7-9e9a-997a8a01fb7c 36987-1328 HUMAN PRESCRIPTION DRUG Thompson Seedless Grape Thompson Seedless Grape INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WINE GRAPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1329_9136cb32-84a8-409d-857e-42ee3cff3460 36987-1329 HUMAN PRESCRIPTION DRUG Thompson Seedless Grape Thompson Seedless Grape INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WINE GRAPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1330_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1330 HUMAN PRESCRIPTION DRUG Grapefruit Grapefruit INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GRAPEFRUIT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1331_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1331 HUMAN PRESCRIPTION DRUG Grapefruit Grapefruit INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GRAPEFRUIT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1332_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1332 HUMAN PRESCRIPTION DRUG Grapefruit Grapefruit INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GRAPEFRUIT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1333_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1333 HUMAN PRESCRIPTION DRUG Grapefruit Grapefruit INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GRAPEFRUIT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1334_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1334 HUMAN PRESCRIPTION DRUG Honeydew Melon Honeydew Melon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HONEYDEW MELON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1335_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1335 HUMAN PRESCRIPTION DRUG Honeydew Melon Honeydew Melon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HONEYDEW MELON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1336_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1336 HUMAN PRESCRIPTION DRUG Honeydew Melon Honeydew Melon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HONEYDEW MELON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1337_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1337 HUMAN PRESCRIPTION DRUG Honeydew Melon Honeydew Melon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HONEYDEW MELON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1338_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1338 HUMAN PRESCRIPTION DRUG Lemon Lemon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1339_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1339 HUMAN PRESCRIPTION DRUG Lemon Lemon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1340_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1340 HUMAN PRESCRIPTION DRUG Lemon Lemon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1341_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1341 HUMAN PRESCRIPTION DRUG Lemon Lemon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1342_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1342 HUMAN PRESCRIPTION DRUG Lime Lime INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIME (CITRUS) .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1343_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1343 HUMAN PRESCRIPTION DRUG Lime Lime INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIME (CITRUS) .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1344_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1344 HUMAN PRESCRIPTION DRUG Lime Lime INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIME (CITRUS) .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1345_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1345 HUMAN PRESCRIPTION DRUG Lime Lime INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIME (CITRUS) .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1346_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1346 HUMAN PRESCRIPTION DRUG Orange Orange INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORANGE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1347_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1347 HUMAN PRESCRIPTION DRUG Orange Orange INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORANGE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1348_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1348 HUMAN PRESCRIPTION DRUG Orange Orange INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORANGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1349_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1349 HUMAN PRESCRIPTION DRUG Orange Orange INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ORANGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1350_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1350 HUMAN PRESCRIPTION DRUG Peach Peach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEACH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1351_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1351 HUMAN PRESCRIPTION DRUG Peach Peach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEACH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1352_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1352 HUMAN PRESCRIPTION DRUG Peach Peach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1353_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1353 HUMAN PRESCRIPTION DRUG Peach Peach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1354_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1354 HUMAN PRESCRIPTION DRUG Pear Pear INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEAR .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1355_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1355 HUMAN PRESCRIPTION DRUG Pear Pear INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEAR .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1356_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1356 HUMAN PRESCRIPTION DRUG Pear Pear INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEAR .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1357_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1357 HUMAN PRESCRIPTION DRUG Pear Pear INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEAR .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1358_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1358 HUMAN PRESCRIPTION DRUG Pineapple Pineapple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINEAPPLE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1359_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1359 HUMAN PRESCRIPTION DRUG Pineapple Pineapple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINEAPPLE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1360_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1360 HUMAN PRESCRIPTION DRUG Pineapple Pineapple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINEAPPLE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1361_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1361 HUMAN PRESCRIPTION DRUG Pineapple Pineapple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINEAPPLE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1362_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1362 HUMAN PRESCRIPTION DRUG Plum Plum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLUM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1363_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1363 HUMAN PRESCRIPTION DRUG Plum Plum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLUM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1364_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1364 HUMAN PRESCRIPTION DRUG Plum Plum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLUM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1365_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1365 HUMAN PRESCRIPTION DRUG Plum Plum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLUM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1366_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1366 HUMAN PRESCRIPTION DRUG Raspberry Raspberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RASPBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1367_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1367 HUMAN PRESCRIPTION DRUG Raspberry Raspberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RASPBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1368_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1368 HUMAN PRESCRIPTION DRUG Raspberry Raspberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RASPBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1369_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1369 HUMAN PRESCRIPTION DRUG Raspberry Raspberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RASPBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1370_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1370 HUMAN PRESCRIPTION DRUG Strawberry Strawberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRAWBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1371_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1371 HUMAN PRESCRIPTION DRUG Strawberry Strawberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRAWBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1372_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1372 HUMAN PRESCRIPTION DRUG Strawberry Strawberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRAWBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1373_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1373 HUMAN PRESCRIPTION DRUG Strawberry Strawberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRAWBERRY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1374_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1374 HUMAN PRESCRIPTION DRUG Tangerine Tangerine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TANGERINE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1375_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1375 HUMAN PRESCRIPTION DRUG Tangerine Tangerine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TANGERINE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1376_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1376 HUMAN PRESCRIPTION DRUG Tangerine Tangerine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TANGERINE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1377_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1377 HUMAN PRESCRIPTION DRUG Tangerine Tangerine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TANGERINE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1378_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1378 HUMAN PRESCRIPTION DRUG Watermelon Watermelon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERMELON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1379_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1379 HUMAN PRESCRIPTION DRUG Watermelon Watermelon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERMELON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1380_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1380 HUMAN PRESCRIPTION DRUG Watermelon Watermelon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERMELON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1381_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1381 HUMAN PRESCRIPTION DRUG Watermelon Watermelon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERMELON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1382_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1382 HUMAN PRESCRIPTION DRUG Artichoke Artichoke INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTICHOKE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1383_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1383 HUMAN PRESCRIPTION DRUG Artichoke Artichoke INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTICHOKE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1384_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1384 HUMAN PRESCRIPTION DRUG Artichoke Artichoke INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTICHOKE .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1385_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1385 HUMAN PRESCRIPTION DRUG Artichoke Artichoke INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTICHOKE .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1386_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1386 HUMAN PRESCRIPTION DRUG Asparagus Asparagus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPARAGUS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1387_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1387 HUMAN PRESCRIPTION DRUG Asparagus Asparagus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPARAGUS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1388_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1388 HUMAN PRESCRIPTION DRUG Asparagus Asparagus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPARAGUS .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1389_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1389 HUMAN PRESCRIPTION DRUG Asparagus Asparagus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPARAGUS .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1390_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1390 HUMAN PRESCRIPTION DRUG Red Kidney Beans Red Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1391_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1391 HUMAN PRESCRIPTION DRUG Red Kidney Beans Red Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1392_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1392 HUMAN PRESCRIPTION DRUG Red Kidney Beans Red Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1393_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1393 HUMAN PRESCRIPTION DRUG Red Kidney Beans Red Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1394_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1394 HUMAN PRESCRIPTION DRUG Lima Beans Lima Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIMA BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1395_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1395 HUMAN PRESCRIPTION DRUG Lima Beans Lima Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIMA BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1396_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1396 HUMAN PRESCRIPTION DRUG Lima Beans Lima Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIMA BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1397_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1397 HUMAN PRESCRIPTION DRUG Lima Beans Lima Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIMA BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1398_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1398 HUMAN PRESCRIPTION DRUG Navy Beans Navy Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1399_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1399 HUMAN PRESCRIPTION DRUG Navy Beans Navy Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1400_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1400 HUMAN PRESCRIPTION DRUG Navy Beans Navy Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1401_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1401 HUMAN PRESCRIPTION DRUG Navy Beans Navy Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1402_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1402 HUMAN PRESCRIPTION DRUG String Beans String Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRING BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1403_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1403 HUMAN PRESCRIPTION DRUG String Beans String Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRING BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1404_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1404 HUMAN PRESCRIPTION DRUG String Beans String Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRING BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1405_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1405 HUMAN PRESCRIPTION DRUG String Beans String Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STRING BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1406_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1406 HUMAN PRESCRIPTION DRUG Beet Beet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEET .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1407_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1407 HUMAN PRESCRIPTION DRUG Beet Beet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEET .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1408_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1408 HUMAN PRESCRIPTION DRUG Beet Beet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEET .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1409_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1409 HUMAN PRESCRIPTION DRUG Beet Beet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BEET .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1410_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1410 HUMAN PRESCRIPTION DRUG Broccoli Broccoli INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROCCOLI .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1411_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1411 HUMAN PRESCRIPTION DRUG Broccoli Broccoli INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROCCOLI .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1412_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1412 HUMAN PRESCRIPTION DRUG Broccoli Broccoli INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROCCOLI .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1413_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1413 HUMAN PRESCRIPTION DRUG Broccoli Broccoli INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROCCOLI .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1414_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1414 HUMAN PRESCRIPTION DRUG Kiwi Kiwi INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIWI FRUIT .05 g/mL E 20171231 36987-1415_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1415 HUMAN PRESCRIPTION DRUG Kiwi Kiwi INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIWI FRUIT .05 g/mL E 20171231 36987-1416_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1416 HUMAN PRESCRIPTION DRUG Kiwi Kiwi INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIWI FRUIT .1 g/mL E 20171231 36987-1417_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1417 HUMAN PRESCRIPTION DRUG Kiwi Kiwi INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIWI FRUIT .1 g/mL E 20171231 36987-1418_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1418 HUMAN PRESCRIPTION DRUG Brussels Sprout Brussels Sprout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRUSSELS SPROUT .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1419_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1419 HUMAN PRESCRIPTION DRUG Brussels Sprout Brussels Sprout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRUSSELS SPROUT .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1420_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1420 HUMAN PRESCRIPTION DRUG Brussels Sprout Brussels Sprout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRUSSELS SPROUT .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1421_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1421 HUMAN PRESCRIPTION DRUG Brussels Sprout Brussels Sprout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRUSSELS SPROUT .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1422_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1422 HUMAN PRESCRIPTION DRUG Cabbage Cabbage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CABBAGE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1423_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1423 HUMAN PRESCRIPTION DRUG Cabbage Cabbage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CABBAGE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1424_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1424 HUMAN PRESCRIPTION DRUG Cabbage Cabbage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CABBAGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1425_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1425 HUMAN PRESCRIPTION DRUG Cabbage Cabbage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CABBAGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1426_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1426 HUMAN PRESCRIPTION DRUG Carrot Carrot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARROT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1427_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1427 HUMAN PRESCRIPTION DRUG Carrot Carrot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARROT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1428_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1428 HUMAN PRESCRIPTION DRUG Carrot Carrot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARROT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1429_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1429 HUMAN PRESCRIPTION DRUG Carrot Carrot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARROT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1430_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1430 HUMAN PRESCRIPTION DRUG Cauliflower Cauliflower INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAULIFLOWER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1431_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1431 HUMAN PRESCRIPTION DRUG Cauliflower Cauliflower INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAULIFLOWER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1432_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1432 HUMAN PRESCRIPTION DRUG Cauliflower Cauliflower INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAULIFLOWER .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1433_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1433 HUMAN PRESCRIPTION DRUG Cauliflower Cauliflower INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CAULIFLOWER .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1434_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1434 HUMAN PRESCRIPTION DRUG Celery Celery INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELERY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1435_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1435 HUMAN PRESCRIPTION DRUG Celery Celery INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELERY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1436_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1436 HUMAN PRESCRIPTION DRUG Celery Celery INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELERY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1437_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1437 HUMAN PRESCRIPTION DRUG Celery Celery INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELERY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1438_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1438 HUMAN PRESCRIPTION DRUG Sweet Corn Sweet Corn INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1439_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1439 HUMAN PRESCRIPTION DRUG Sweet Corn Sweet Corn INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1440_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1440 HUMAN PRESCRIPTION DRUG Sweet Corn Sweet Corn INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1441_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1441 HUMAN PRESCRIPTION DRUG Sweet Corn Sweet Corn INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1442_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1442 HUMAN PRESCRIPTION DRUG Cucumber Cucumber INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUCUMBER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1443_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1443 HUMAN PRESCRIPTION DRUG Cucumber Cucumber INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUCUMBER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1444_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1444 HUMAN PRESCRIPTION DRUG Cucumber Cucumber INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUCUMBER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1445_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1445 HUMAN PRESCRIPTION DRUG Cucumber Cucumber INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUCUMBER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1446_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1446 HUMAN PRESCRIPTION DRUG Egg Plant Egg Plant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGGPLANT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1447_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1447 HUMAN PRESCRIPTION DRUG Egg Plant Egg Plant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGGPLANT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1448_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1448 HUMAN PRESCRIPTION DRUG Egg Plant Egg Plant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGGPLANT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1449_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1449 HUMAN PRESCRIPTION DRUG Egg Plant Egg Plant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EGGPLANT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1450_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1450 HUMAN PRESCRIPTION DRUG Green Pepper Green Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN BELL PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1451_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1451 HUMAN PRESCRIPTION DRUG Green Pepper Green Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN BELL PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1452_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1452 HUMAN PRESCRIPTION DRUG Green Pepper Green Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN BELL PEPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1453_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1453 HUMAN PRESCRIPTION DRUG Green Pepper Green Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN BELL PEPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1454_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1454 HUMAN PRESCRIPTION DRUG Lentil Lentil INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LENTIL .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1455_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1455 HUMAN PRESCRIPTION DRUG Lentil Lentil INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LENTIL .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1456_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1456 HUMAN PRESCRIPTION DRUG Lentil Lentil INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LENTIL .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1457_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1457 HUMAN PRESCRIPTION DRUG Lentil Lentil INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LENTIL .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1458_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1458 HUMAN PRESCRIPTION DRUG Iceberg Lettuce Iceberg Lettuce INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LETTUCE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1459_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1459 HUMAN PRESCRIPTION DRUG Iceberg Lettuce Iceberg Lettuce INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LETTUCE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1460_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1460 HUMAN PRESCRIPTION DRUG Iceberg Lettuce Iceberg Lettuce INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LETTUCE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1461_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1461 HUMAN PRESCRIPTION DRUG Iceberg Lettuce Iceberg Lettuce INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LETTUCE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1462_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1462 HUMAN PRESCRIPTION DRUG Mushroom Mushroom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CULTIVATED MUSHROOM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-1463_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1463 HUMAN PRESCRIPTION DRUG Mushroom Mushroom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CULTIVATED MUSHROOM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-1464_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1464 HUMAN PRESCRIPTION DRUG Mushroom Mushroom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CULTIVATED MUSHROOM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-1465_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1465 HUMAN PRESCRIPTION DRUG Mushroom Mushroom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CULTIVATED MUSHROOM .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-1466_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1466 HUMAN PRESCRIPTION DRUG Black Olive Black Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK OLIVE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1467_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1467 HUMAN PRESCRIPTION DRUG Black Olive Black Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK OLIVE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1468_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1468 HUMAN PRESCRIPTION DRUG Black Olive Black Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK OLIVE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1469_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1469 HUMAN PRESCRIPTION DRUG Black Olive Black Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK OLIVE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1470_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1470 HUMAN PRESCRIPTION DRUG Green Olive Green Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN OLIVE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1471_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1471 HUMAN PRESCRIPTION DRUG Green Olive Green Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN OLIVE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1472_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1472 HUMAN PRESCRIPTION DRUG Green Olive Green Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN OLIVE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1473_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1473 HUMAN PRESCRIPTION DRUG Green Olive Green Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GREEN OLIVE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1474_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1474 HUMAN PRESCRIPTION DRUG Yellow Onion Yellow Onion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ONION .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1475_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1475 HUMAN PRESCRIPTION DRUG Yellow Onion Yellow Onion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ONION .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1476_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1476 HUMAN PRESCRIPTION DRUG Yellow Onion Yellow Onion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ONION .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1477_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1477 HUMAN PRESCRIPTION DRUG Yellow Onion Yellow Onion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ONION .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1478_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1478 HUMAN PRESCRIPTION DRUG Parsley Parsley INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1479_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1479 HUMAN PRESCRIPTION DRUG Parsley Parsley INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1480_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1480 HUMAN PRESCRIPTION DRUG Parsley Parsley INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1481_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1481 HUMAN PRESCRIPTION DRUG Parsley Parsley INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1482_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1482 HUMAN PRESCRIPTION DRUG Green Pea Green Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1483_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1483 HUMAN PRESCRIPTION DRUG Green Pea Green Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1484_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1484 HUMAN PRESCRIPTION DRUG Green Pea Green Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1485_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1485 HUMAN PRESCRIPTION DRUG Green Pea Green Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1486_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1486 HUMAN PRESCRIPTION DRUG Sweet Potato Sweet Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWEET POTATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1487_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1487 HUMAN PRESCRIPTION DRUG Sweet Potato Sweet Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWEET POTATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1488_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1488 HUMAN PRESCRIPTION DRUG Sweet Potato Sweet Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWEET POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1489_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1489 HUMAN PRESCRIPTION DRUG Sweet Potato Sweet Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SWEET POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1490_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1490 HUMAN PRESCRIPTION DRUG White Potato White Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POTATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1491_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1491 HUMAN PRESCRIPTION DRUG White Potato White Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POTATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1492_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1492 HUMAN PRESCRIPTION DRUG White Potato White Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1493_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1493 HUMAN PRESCRIPTION DRUG White Potato White Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1494_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1494 HUMAN PRESCRIPTION DRUG Pumpkin Pumpkin INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- PUMPKIN CUCURBITA PEPO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1495_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1495 HUMAN PRESCRIPTION DRUG Pumpkin Pumpkin INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- PUMPKIN CUCURBITA PEPO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1496_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1496 HUMAN PRESCRIPTION DRUG Pumpkin Pumpkin INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- PUMPKIN CUCURBITA PEPO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1497_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1497 HUMAN PRESCRIPTION DRUG Pumpkin Pumpkin INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- PUMPKIN CUCURBITA PEPO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1498_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1498 HUMAN PRESCRIPTION DRUG Radish Radish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RAPHANUS SATIVUS .05 g/mL E 20171231 36987-1499_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1499 HUMAN PRESCRIPTION DRUG Radish Radish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RAPHANUS SATIVUS .05 g/mL E 20171231 36987-1500_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1500 HUMAN PRESCRIPTION DRUG Radish Radish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RAPHANUS SATIVUS .1 g/mL E 20171231 36987-1501_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1501 HUMAN PRESCRIPTION DRUG Radish Radish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RAPHANUS SATIVUS .1 g/mL E 20171231 36987-1502_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1502 HUMAN PRESCRIPTION DRUG Rhubarb Rhubarb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHUBARB .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1503_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1503 HUMAN PRESCRIPTION DRUG Rhubarb Rhubarb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHUBARB .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1504_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1504 HUMAN PRESCRIPTION DRUG Rhubarb Rhubarb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHUBARB .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1505_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1505 HUMAN PRESCRIPTION DRUG Rhubarb Rhubarb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHUBARB .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1506_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1506 HUMAN PRESCRIPTION DRUG Soybean Soybean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOYBEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1507_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1507 HUMAN PRESCRIPTION DRUG Soybean Soybean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOYBEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1508_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1508 HUMAN PRESCRIPTION DRUG Soybean Soybean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOYBEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1509_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1509 HUMAN PRESCRIPTION DRUG Soybean Soybean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOYBEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1510_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1510 HUMAN PRESCRIPTION DRUG Spinach Spinach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPINACH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1511_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1511 HUMAN PRESCRIPTION DRUG Spinach Spinach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPINACH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1512_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1512 HUMAN PRESCRIPTION DRUG Spinach Spinach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPINACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1513_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1513 HUMAN PRESCRIPTION DRUG Spinach Spinach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPINACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1514_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1514 HUMAN PRESCRIPTION DRUG Squash Zucchini Squash Zucchini INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SQUASH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1515_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1515 HUMAN PRESCRIPTION DRUG Squash Zucchini Squash Zucchini INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SQUASH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1516_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1516 HUMAN PRESCRIPTION DRUG Squash Zucchini Squash Zucchini INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SQUASH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1517_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1517 HUMAN PRESCRIPTION DRUG Squash Zucchini Squash Zucchini INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SQUASH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1518_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1518 HUMAN PRESCRIPTION DRUG Tomato Tomato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOMATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1519_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1519 HUMAN PRESCRIPTION DRUG Tomato Tomato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOMATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1520_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1520 HUMAN PRESCRIPTION DRUG Tomato Tomato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOMATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1521_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1521 HUMAN PRESCRIPTION DRUG Tomato Tomato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOMATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1522_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1522 HUMAN PRESCRIPTION DRUG Turnip Turnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURNIP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1523_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1523 HUMAN PRESCRIPTION DRUG Turnip Turnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURNIP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1524_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1524 HUMAN PRESCRIPTION DRUG Turnip Turnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURNIP .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1525_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1525 HUMAN PRESCRIPTION DRUG Turnip Turnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TURNIP .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1526_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1526 HUMAN PRESCRIPTION DRUG Almond Almond INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALMOND .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1527_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1527 HUMAN PRESCRIPTION DRUG Almond Almond INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALMOND .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1528_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1528 HUMAN PRESCRIPTION DRUG Almond Almond INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALMOND .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1529_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1529 HUMAN PRESCRIPTION DRUG Almond Almond INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALMOND .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1530_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1530 HUMAN PRESCRIPTION DRUG Brazil Nut Brazil Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRAZIL NUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1531_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1531 HUMAN PRESCRIPTION DRUG Brazil Nut Brazil Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRAZIL NUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1532_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1532 HUMAN PRESCRIPTION DRUG Brazil Nut Brazil Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRAZIL NUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1533_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1533 HUMAN PRESCRIPTION DRUG Brazil Nut Brazil Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BRAZIL NUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1534_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1534 HUMAN PRESCRIPTION DRUG Cashew Cashew INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASHEW .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1535_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1535 HUMAN PRESCRIPTION DRUG Cashew Cashew INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASHEW .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1536_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1536 HUMAN PRESCRIPTION DRUG Cashew Cashew INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASHEW .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1537_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1537 HUMAN PRESCRIPTION DRUG Cashew Cashew INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASHEW .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1538_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1538 HUMAN PRESCRIPTION DRUG Coconut Coconut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCONUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1539_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1539 HUMAN PRESCRIPTION DRUG Coconut Coconut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCONUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1540_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1540 HUMAN PRESCRIPTION DRUG Coconut Coconut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCONUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1541_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1541 HUMAN PRESCRIPTION DRUG Coconut Coconut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCONUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1542_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1542 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ENGLISH WALNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1543_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1543 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ENGLISH WALNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1544_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1544 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ENGLISH WALNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1545_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1545 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ENGLISH WALNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1546_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1546 HUMAN PRESCRIPTION DRUG Filbert Filbert INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HAZELNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1547_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1547 HUMAN PRESCRIPTION DRUG Filbert Filbert INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HAZELNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1548_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1548 HUMAN PRESCRIPTION DRUG Filbert Filbert INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HAZELNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1549_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1549 HUMAN PRESCRIPTION DRUG Filbert Filbert INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HAZELNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1550_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1550 HUMAN PRESCRIPTION DRUG Peanut Peanut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEANUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1551_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1551 HUMAN PRESCRIPTION DRUG Peanut Peanut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEANUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1552_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1552 HUMAN PRESCRIPTION DRUG Peanut Peanut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEANUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1553_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1553 HUMAN PRESCRIPTION DRUG Peanut Peanut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEANUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1554_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1554 HUMAN PRESCRIPTION DRUG Pecan Nut Pecan Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PECAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1555_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1555 HUMAN PRESCRIPTION DRUG Pecan Nut Pecan Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PECAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1556_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1556 HUMAN PRESCRIPTION DRUG Pecan Nut Pecan Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PECAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1557_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1557 HUMAN PRESCRIPTION DRUG Pecan Nut Pecan Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PECAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1558_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1558 HUMAN PRESCRIPTION DRUG Pistachio Pistachio INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PISTACHIO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1559_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1559 HUMAN PRESCRIPTION DRUG Pistachio Pistachio INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PISTACHIO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1560_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1560 HUMAN PRESCRIPTION DRUG Pistachio Pistachio INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PISTACHIO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1561_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1561 HUMAN PRESCRIPTION DRUG Pistachio Pistachio INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PISTACHIO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1562_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1562 HUMAN PRESCRIPTION DRUG Barley Grain Barley Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BARLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1563_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1563 HUMAN PRESCRIPTION DRUG Barley Grain Barley Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BARLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1564_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1564 HUMAN PRESCRIPTION DRUG Barley Grain Barley Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BARLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1565_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1565 HUMAN PRESCRIPTION DRUG Barley Grain Barley Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BARLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1566_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1566 HUMAN PRESCRIPTION DRUG Buckwheat Grain Buckwheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BUCKWHEAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1567_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1567 HUMAN PRESCRIPTION DRUG Buckwheat Grain Buckwheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BUCKWHEAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1568_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1568 HUMAN PRESCRIPTION DRUG Buckwheat Grain Buckwheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BUCKWHEAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1569_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1569 HUMAN PRESCRIPTION DRUG Buckwheat Grain Buckwheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BUCKWHEAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1570_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1570 HUMAN PRESCRIPTION DRUG Oat Grain Oat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1571_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1571 HUMAN PRESCRIPTION DRUG Oat Grain Oat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1572_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1572 HUMAN PRESCRIPTION DRUG Oat Grain Oat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1573_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1573 HUMAN PRESCRIPTION DRUG Oat Grain Oat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1574_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1574 HUMAN PRESCRIPTION DRUG Rice Grain Rice Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RICE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1575_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1575 HUMAN PRESCRIPTION DRUG Rice Grain Rice Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RICE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1576_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1576 HUMAN PRESCRIPTION DRUG Rice Grain Rice Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RICE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1577_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1577 HUMAN PRESCRIPTION DRUG Rice Grain Rice Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RICE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1578_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1578 HUMAN PRESCRIPTION DRUG Rye Grain Rye Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RYE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1579_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1579 HUMAN PRESCRIPTION DRUG Rye Grain Rye Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RYE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1580_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1580 HUMAN PRESCRIPTION DRUG Rye Grain Rye Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RYE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1581_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1581 HUMAN PRESCRIPTION DRUG Rye Grain Rye Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RYE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1582_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1582 HUMAN PRESCRIPTION DRUG Whole Wheat Grain Whole Wheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1583_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1583 HUMAN PRESCRIPTION DRUG Whole Wheat Grain Whole Wheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1584_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1584 HUMAN PRESCRIPTION DRUG Whole Wheat Grain Whole Wheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1585_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1585 HUMAN PRESCRIPTION DRUG Whole Wheat Grain Whole Wheat Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1586_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1586 HUMAN PRESCRIPTION DRUG Macadamia Nut Macadamia Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACADAMIA NUT .05 g/mL E 20171231 36987-1587_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1587 HUMAN PRESCRIPTION DRUG Macadamia Nut Macadamia Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACADAMIA NUT .05 g/mL E 20171231 36987-1588_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1588 HUMAN PRESCRIPTION DRUG Macadamia Nut Macadamia Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACADAMIA NUT .1 g/mL E 20171231 36987-1589_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1589 HUMAN PRESCRIPTION DRUG Macadamia Nut Macadamia Nut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MACADAMIA NUT .1 g/mL E 20171231 36987-1590_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1590 HUMAN PRESCRIPTION DRUG Nectarine Nectarine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NECTARINE .05 g/mL E 20171231 36987-1591_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1591 HUMAN PRESCRIPTION DRUG Nectarine Nectarine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NECTARINE .05 g/mL E 20171231 36987-1592_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1592 HUMAN PRESCRIPTION DRUG Nectarine Nectarine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NECTARINE .1 g/mL E 20171231 36987-1593_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1593 HUMAN PRESCRIPTION DRUG Nectarine Nectarine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NECTARINE .1 g/mL E 20171231 36987-1594_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1594 HUMAN PRESCRIPTION DRUG Mango Mango INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1595_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1595 HUMAN PRESCRIPTION DRUG Mango Mango INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1596_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1596 HUMAN PRESCRIPTION DRUG Mango Mango INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1597_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1597 HUMAN PRESCRIPTION DRUG Mango Mango INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1598_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1598 HUMAN PRESCRIPTION DRUG Papaya Papaya INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPAYA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1599_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1599 HUMAN PRESCRIPTION DRUG Papaya Papaya INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPAYA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1600_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1600 HUMAN PRESCRIPTION DRUG Papaya Papaya INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPAYA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1601_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1601 HUMAN PRESCRIPTION DRUG Papaya Papaya INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPAYA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 36987-1602_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1602 HUMAN PRESCRIPTION DRUG Leeks Leeks INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEEK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1603_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1603 HUMAN PRESCRIPTION DRUG Leeks Leeks INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEEK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1604_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1604 HUMAN PRESCRIPTION DRUG Leeks Leeks INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEEK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1605_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1605 HUMAN PRESCRIPTION DRUG Leeks Leeks INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEEK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1606_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1606 HUMAN PRESCRIPTION DRUG Okra Okra INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OKRA .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1607_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1607 HUMAN PRESCRIPTION DRUG Okra Okra INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OKRA .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1608_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1608 HUMAN PRESCRIPTION DRUG Okra Okra INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OKRA .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1609_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1609 HUMAN PRESCRIPTION DRUG Okra Okra INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OKRA .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1610_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1610 HUMAN PRESCRIPTION DRUG Parsnip Parsnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSNIP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1611_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1611 HUMAN PRESCRIPTION DRUG Parsnip Parsnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSNIP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1612_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1612 HUMAN PRESCRIPTION DRUG Parsnip Parsnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSNIP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1613_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1613 HUMAN PRESCRIPTION DRUG Parsnip Parsnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PARSNIP .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1614_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1614 HUMAN PRESCRIPTION DRUG Chick Pea Chick Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKPEA .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1615_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1615 HUMAN PRESCRIPTION DRUG Chick Pea Chick Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKPEA .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1616_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1616 HUMAN PRESCRIPTION DRUG Chick Pea Chick Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKPEA .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1617_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1617 HUMAN PRESCRIPTION DRUG Chick Pea Chick Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHICKPEA .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1618_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1618 HUMAN PRESCRIPTION DRUG Blackeye Pea Blackeye Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK-EYED PEA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 36987-1619_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1619 HUMAN PRESCRIPTION DRUG Blackeye Pea Blackeye Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK-EYED PEA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 36987-1620_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1620 HUMAN PRESCRIPTION DRUG Blackeye Pea Blackeye Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK-EYED PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 36987-1621_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1621 HUMAN PRESCRIPTION DRUG Blackeye Pea Blackeye Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK-EYED PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 36987-1622_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1622 HUMAN PRESCRIPTION DRUG Watercress Watercress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERCRESS .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1623_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1623 HUMAN PRESCRIPTION DRUG Watercress Watercress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERCRESS .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1624_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1624 HUMAN PRESCRIPTION DRUG Watercress Watercress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERCRESS .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1625_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1625 HUMAN PRESCRIPTION DRUG Watercress Watercress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WATERCRESS .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1626_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1626 HUMAN PRESCRIPTION DRUG Corn Grain Corn Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1627_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1627 HUMAN PRESCRIPTION DRUG Corn Grain Corn Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1628_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1628 HUMAN PRESCRIPTION DRUG Corn Grain Corn Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1629_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1629 HUMAN PRESCRIPTION DRUG Corn Grain Corn Grain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1630_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1630 HUMAN PRESCRIPTION DRUG Cacao Bean Cacao Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHOCOLATE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1631_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1631 HUMAN PRESCRIPTION DRUG Cacao Bean Cacao Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHOCOLATE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1632_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1632 HUMAN PRESCRIPTION DRUG Cacao Bean Cacao Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHOCOLATE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1633_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1633 HUMAN PRESCRIPTION DRUG Cacao Bean Cacao Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHOCOLATE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1634_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1634 HUMAN PRESCRIPTION DRUG Coffee Coffee INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARABICA COFFEE BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1635_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1635 HUMAN PRESCRIPTION DRUG Coffee Coffee INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARABICA COFFEE BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1636_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1636 HUMAN PRESCRIPTION DRUG Coffee Coffee INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARABICA COFFEE BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1637_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1637 HUMAN PRESCRIPTION DRUG Coffee Coffee INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARABICA COFFEE BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1638_d776fd84-c01f-4483-9146-5d715e675716 36987-1638 HUMAN PRESCRIPTION DRUG Arabic Gum Arabic Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA .005 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1640_d776fd84-c01f-4483-9146-5d715e675716 36987-1640 HUMAN PRESCRIPTION DRUG Arabic Gum Arabic Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA .01 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1642_d776fd84-c01f-4483-9146-5d715e675716 36987-1642 HUMAN PRESCRIPTION DRUG Karaya Gum Karaya Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KARAYA GUM .005 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1644_d776fd84-c01f-4483-9146-5d715e675716 36987-1644 HUMAN PRESCRIPTION DRUG Karaya Gum Karaya Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KARAYA GUM .01 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1646_d776fd84-c01f-4483-9146-5d715e675716 36987-1646 HUMAN PRESCRIPTION DRUG Tragacanth Gum Tragacanth Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRAGACANTH .005 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1648_d776fd84-c01f-4483-9146-5d715e675716 36987-1648 HUMAN PRESCRIPTION DRUG Tragacanth Gum Tragacanth Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRAGACANTH .01 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1650_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1650 HUMAN PRESCRIPTION DRUG Malt Malt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MALT EXTRACT, BARLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1651_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1651 HUMAN PRESCRIPTION DRUG Malt Malt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MALT EXTRACT, BARLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1652_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1652 HUMAN PRESCRIPTION DRUG Malt Malt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MALT EXTRACT, BARLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1653_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1653 HUMAN PRESCRIPTION DRUG Malt Malt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MALT EXTRACT, BARLEY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 36987-1654_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1654 HUMAN PRESCRIPTION DRUG Orange Pekoe Tea Orange Pekoe Tea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TEA LEAF .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1655_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1655 HUMAN PRESCRIPTION DRUG Orange Pekoe Tea Orange Pekoe Tea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TEA LEAF .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1656_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1656 HUMAN PRESCRIPTION DRUG Orange Pekoe Tea Orange Pekoe Tea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TEA LEAF .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1657_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1657 HUMAN PRESCRIPTION DRUG Orange Pekoe Tea Orange Pekoe Tea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TEA LEAF .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1658_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1658 HUMAN PRESCRIPTION DRUG Brewers Yeast Brewers Yeast INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-1659_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1659 HUMAN PRESCRIPTION DRUG Brewers Yeast Brewers Yeast INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-1660_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1660 HUMAN PRESCRIPTION DRUG Brewers Yeast Brewers Yeast INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-1661_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1661 HUMAN PRESCRIPTION DRUG Brewers Yeast Brewers Yeast INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-1662_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1662 HUMAN PRESCRIPTION DRUG Allspice Allspice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLSPICE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1663_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1663 HUMAN PRESCRIPTION DRUG Allspice Allspice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLSPICE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1664_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1664 HUMAN PRESCRIPTION DRUG Allspice Allspice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLSPICE .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1665_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1665 HUMAN PRESCRIPTION DRUG Allspice Allspice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLSPICE .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1666_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1666 HUMAN PRESCRIPTION DRUG Bay Leaf Bay Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAURUS NOBILIS .05 g/mL E 20171231 36987-1667_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1667 HUMAN PRESCRIPTION DRUG Bay Leaf Bay Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAURUS NOBILIS .05 g/mL E 20171231 36987-1668_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1668 HUMAN PRESCRIPTION DRUG Bay Leaf Bay Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAURUS NOBILIS .1 g/mL E 20171231 36987-1669_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1669 HUMAN PRESCRIPTION DRUG Bay Leaf Bay Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LAURUS NOBILIS .1 g/mL E 20171231 36987-1670_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1670 HUMAN PRESCRIPTION DRUG Caraway Seed Caraway Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARAWAY SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1671_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1671 HUMAN PRESCRIPTION DRUG Caraway Seed Caraway Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARAWAY SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1672_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1672 HUMAN PRESCRIPTION DRUG Caraway Seed Caraway Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARAWAY SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1673_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1673 HUMAN PRESCRIPTION DRUG Caraway Seed Caraway Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARAWAY SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1674_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1674 HUMAN PRESCRIPTION DRUG Cinnamon Cinnamon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CINNAMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1675_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1675 HUMAN PRESCRIPTION DRUG Cinnamon Cinnamon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CINNAMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1676_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1676 HUMAN PRESCRIPTION DRUG Cinnamon Cinnamon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CINNAMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1677_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1677 HUMAN PRESCRIPTION DRUG Cinnamon Cinnamon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CINNAMON .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1678_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1678 HUMAN PRESCRIPTION DRUG Cloves Cloves INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLOVE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1679_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1679 HUMAN PRESCRIPTION DRUG Cloves Cloves INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLOVE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1680_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1680 HUMAN PRESCRIPTION DRUG Cloves Cloves INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLOVE .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1681_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1681 HUMAN PRESCRIPTION DRUG Cloves Cloves INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLOVE .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1686_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1686 HUMAN PRESCRIPTION DRUG Dill Dill INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DILL .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1687_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1687 HUMAN PRESCRIPTION DRUG Dill Dill INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DILL .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1688_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1688 HUMAN PRESCRIPTION DRUG Dill Dill INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DILL .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1689_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1689 HUMAN PRESCRIPTION DRUG Dill Dill INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DILL .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1690_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1690 HUMAN PRESCRIPTION DRUG Garlic Garlic INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARLIC .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1691_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1691 HUMAN PRESCRIPTION DRUG Garlic Garlic INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARLIC .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1692_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1692 HUMAN PRESCRIPTION DRUG Garlic Garlic INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARLIC .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1693_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1693 HUMAN PRESCRIPTION DRUG Garlic Garlic INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARLIC .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1694_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1694 HUMAN PRESCRIPTION DRUG Ginger Ginger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GINGER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1695_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1695 HUMAN PRESCRIPTION DRUG Ginger Ginger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GINGER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1696_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1696 HUMAN PRESCRIPTION DRUG Ginger Ginger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GINGER .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1697_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1697 HUMAN PRESCRIPTION DRUG Ginger Ginger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GINGER .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1698_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1698 HUMAN PRESCRIPTION DRUG Horseradish Horseradish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HORSERADISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1699_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1699 HUMAN PRESCRIPTION DRUG Horseradish Horseradish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HORSERADISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1700_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1700 HUMAN PRESCRIPTION DRUG Horseradish Horseradish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HORSERADISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1701_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1701 HUMAN PRESCRIPTION DRUG Horseradish Horseradish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HORSERADISH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1702_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1702 HUMAN PRESCRIPTION DRUG Licorice Licorice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LICORICE .05 g/mL E 20171231 36987-1703_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1703 HUMAN PRESCRIPTION DRUG Licorice Licorice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LICORICE .05 g/mL E 20171231 36987-1704_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1704 HUMAN PRESCRIPTION DRUG Licorice Licorice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LICORICE .1 g/mL E 20171231 36987-1705_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1705 HUMAN PRESCRIPTION DRUG Licorice Licorice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LICORICE .1 g/mL E 20171231 36987-1706_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1706 HUMAN PRESCRIPTION DRUG Mustard Seed Mustard Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSTARD SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1707_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1707 HUMAN PRESCRIPTION DRUG Mustard Seed Mustard Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSTARD SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1708_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1708 HUMAN PRESCRIPTION DRUG Mustard Seed Mustard Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSTARD SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1709_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1709 HUMAN PRESCRIPTION DRUG Mustard Seed Mustard Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSTARD SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1710_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1710 HUMAN PRESCRIPTION DRUG Nutmeg Nutmeg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NUTMEG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1711_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1711 HUMAN PRESCRIPTION DRUG Nutmeg Nutmeg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NUTMEG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1712_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1712 HUMAN PRESCRIPTION DRUG Nutmeg Nutmeg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NUTMEG .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1713_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1713 HUMAN PRESCRIPTION DRUG Nutmeg Nutmeg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NUTMEG .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1714_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1714 HUMAN PRESCRIPTION DRUG Oregano Oregano INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OREGANO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1715_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1715 HUMAN PRESCRIPTION DRUG Oregano Oregano INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OREGANO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1716_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1716 HUMAN PRESCRIPTION DRUG Oregano Oregano INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OREGANO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1717_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1717 HUMAN PRESCRIPTION DRUG Oregano Oregano INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OREGANO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1718_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1718 HUMAN PRESCRIPTION DRUG Paprika Paprika INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPRIKA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1719_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1719 HUMAN PRESCRIPTION DRUG Paprika Paprika INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPRIKA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1720_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1720 HUMAN PRESCRIPTION DRUG Paprika Paprika INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPRIKA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1721_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1721 HUMAN PRESCRIPTION DRUG Paprika Paprika INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PAPRIKA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1722_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1722 HUMAN PRESCRIPTION DRUG White Pepper White Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE PEPPER .05 g/mL E 20171231 36987-1723_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1723 HUMAN PRESCRIPTION DRUG White Pepper White Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE PEPPER .05 g/mL E 20171231 36987-1724_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1724 HUMAN PRESCRIPTION DRUG White Pepper White Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE PEPPER .1 g/mL E 20171231 36987-1725_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1725 HUMAN PRESCRIPTION DRUG White Pepper White Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHITE PEPPER .1 g/mL E 20171231 36987-1726_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1726 HUMAN PRESCRIPTION DRUG Peppermint Peppermint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEPPERMINT FLOWERING TOP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1727_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1727 HUMAN PRESCRIPTION DRUG Peppermint Peppermint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEPPERMINT FLOWERING TOP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1728_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1728 HUMAN PRESCRIPTION DRUG Peppermint Peppermint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEPPERMINT FLOWERING TOP .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1729_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1729 HUMAN PRESCRIPTION DRUG Peppermint Peppermint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PEPPERMINT FLOWERING TOP .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1730_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1730 HUMAN PRESCRIPTION DRUG Poppyseed Poppyseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPPY SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1731_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1731 HUMAN PRESCRIPTION DRUG Poppyseed Poppyseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPPY SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1732_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1732 HUMAN PRESCRIPTION DRUG Poppyseed Poppyseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPPY SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1733_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1733 HUMAN PRESCRIPTION DRUG Poppyseed Poppyseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPPY SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-1734_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1734 HUMAN PRESCRIPTION DRUG Sage Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALVIA OFFICINALIS .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1735_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1735 HUMAN PRESCRIPTION DRUG Sage Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALVIA OFFICINALIS .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1736_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1736 HUMAN PRESCRIPTION DRUG Sage Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALVIA OFFICINALIS .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1737_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1737 HUMAN PRESCRIPTION DRUG Sage Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALVIA OFFICINALIS .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1738_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1738 HUMAN PRESCRIPTION DRUG Sesame Sesame INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SESAME SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1739_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1739 HUMAN PRESCRIPTION DRUG Sesame Sesame INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SESAME SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1740_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1740 HUMAN PRESCRIPTION DRUG Sesame Sesame INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SESAME SEED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1741_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1741 HUMAN PRESCRIPTION DRUG Sesame Sesame INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SESAME SEED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-1742_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1742 HUMAN PRESCRIPTION DRUG Spearmint Spearmint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPEARMINT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 36987-1743_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1743 HUMAN PRESCRIPTION DRUG Spearmint Spearmint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPEARMINT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 36987-1744_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1744 HUMAN PRESCRIPTION DRUG Spearmint Spearmint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPEARMINT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 36987-1745_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1745 HUMAN PRESCRIPTION DRUG Spearmint Spearmint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SPEARMINT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 36987-1746_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1746 HUMAN PRESCRIPTION DRUG Thyme Thym INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARDEN THYME .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1747_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1747 HUMAN PRESCRIPTION DRUG Thyme Thym INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARDEN THYME .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1748_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1748 HUMAN PRESCRIPTION DRUG Thyme Thym INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARDEN THYME .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1749_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1749 HUMAN PRESCRIPTION DRUG Thyme Thym INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GARDEN THYME .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1750_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1750 HUMAN PRESCRIPTION DRUG Vanilla Vanilla INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VANILLA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1751_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1751 HUMAN PRESCRIPTION DRUG Vanilla Vanilla INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VANILLA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1752_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1752 HUMAN PRESCRIPTION DRUG Vanilla Vanilla INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VANILLA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1753_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1753 HUMAN PRESCRIPTION DRUG Vanilla Vanilla INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. VANILLA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1754_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1754 HUMAN PRESCRIPTION DRUG Wheat Bran Wheat Bran INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT BRAN .05 g/mL E 20171231 36987-1755_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1755 HUMAN PRESCRIPTION DRUG Wheat Bran Wheat Bran INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT BRAN .05 g/mL E 20171231 36987-1756_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1756 HUMAN PRESCRIPTION DRUG Wheat Bran Wheat Bran INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT BRAN .1 g/mL E 20171231 36987-1757_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1757 HUMAN PRESCRIPTION DRUG Wheat Bran Wheat Bran INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. WHEAT BRAN .1 g/mL E 20171231 36987-1758_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1758 HUMAN PRESCRIPTION DRUG White Kidney Beans White Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1759_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1759 HUMAN PRESCRIPTION DRUG White Kidney Beans White Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1760_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1760 HUMAN PRESCRIPTION DRUG White Kidney Beans White Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1761_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1761 HUMAN PRESCRIPTION DRUG White Kidney Beans White Kidney Beans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KIDNEY BEAN .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1766_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1766 HUMAN PRESCRIPTION DRUG Black Pepper Black Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1767_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1767 HUMAN PRESCRIPTION DRUG Black Pepper Black Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1768_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1768 HUMAN PRESCRIPTION DRUG Black Pepper Black Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK PEPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1769_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1769 HUMAN PRESCRIPTION DRUG Black Pepper Black Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BLACK PEPPER .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 36987-1770_a0de52d8-af70-4f43-8468-3b7a42072d2f 36987-1770 HUMAN PRESCRIPTION DRUG Chestnut Chestnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMERICAN CHESTNUT .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1771_b82c13c6-5ea4-422b-9aaf-fffe61a501d6 36987-1771 HUMAN PRESCRIPTION DRUG Chestnut Chestnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMERICAN CHESTNUT .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1772_274649f0-2ad5-4bfe-a4b1-f79e1155293a 36987-1772 HUMAN PRESCRIPTION DRUG Chestnut Chestnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMERICAN CHESTNUT .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1773_a99f08f8-155a-4bb9-a56b-0f5c78144a19 36987-1773 HUMAN PRESCRIPTION DRUG Chestnut Chestnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMERICAN CHESTNUT .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 36987-1774_dec580ea-73db-4658-9de1-440c19bb42b7 36987-1774 HUMAN PRESCRIPTION DRUG Hops Hops INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOPS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1775_c9d2ad91-0541-4504-a528-c0cc93a99e4e 36987-1775 HUMAN PRESCRIPTION DRUG Hops Hops INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOPS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1776_20425e8b-8db3-4a2b-813b-7e3e1bc1c4e6 36987-1776 HUMAN PRESCRIPTION DRUG Hops Hops INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOPS .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1777_255e0c54-6613-460b-a91f-452fdfd0319d 36987-1777 HUMAN PRESCRIPTION DRUG Hops Hops INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HOPS .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 36987-1778_72ccd3a1-bbd2-46cc-8bb6-970a8a2f1874 36987-1778 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA 10000 [PNU]/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1779_f243b580-e924-4bc5-9214-b3dfdf50a0a5 36987-1779 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA 10000 [PNU]/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1780_5a479ad2-b047-43df-a87a-e6d227a0ca2f 36987-1780 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA 20000 [PNU]/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1781_b867c176-bd24-4801-a83d-6ffe9619374a 36987-1781 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA 20000 [PNU]/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1782_0dfdf82e-c929-42cd-8393-5392bfe2ea7c 36987-1782 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA .05 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1783_134fa1e6-4218-4138-b3e8-50dbbbe2e42a 36987-1783 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA .05 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1784_c78e08bb-dbe9-40a7-92d5-c9c5d0403765 36987-1784 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA .1 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1785_cb84ead7-2044-4cda-8f02-0da04fa5fff4 36987-1785 HUMAN PRESCRIPTION DRUG Fire Ant Fire Ant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLENOPSIS INVICTA .1 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1786_72ccd3a1-bbd2-46cc-8bb6-970a8a2f1874 36987-1786 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1787_f243b580-e924-4bc5-9214-b3dfdf50a0a5 36987-1787 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1788_5a479ad2-b047-43df-a87a-e6d227a0ca2f 36987-1788 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1789_b867c176-bd24-4801-a83d-6ffe9619374a 36987-1789 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1790_0dfdf82e-c929-42cd-8393-5392bfe2ea7c 36987-1790 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1791_134fa1e6-4218-4138-b3e8-50dbbbe2e42a 36987-1791 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1792_c78e08bb-dbe9-40a7-92d5-c9c5d0403765 36987-1792 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1793_cb84ead7-2044-4cda-8f02-0da04fa5fff4 36987-1793 HUMAN PRESCRIPTION DRUG House Fly House Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1794_72ccd3a1-bbd2-46cc-8bb6-970a8a2f1874 36987-1794 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1795_f243b580-e924-4bc5-9214-b3dfdf50a0a5 36987-1795 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1796_5a479ad2-b047-43df-a87a-e6d227a0ca2f 36987-1796 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1797_b867c176-bd24-4801-a83d-6ffe9619374a 36987-1797 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1798_0dfdf82e-c929-42cd-8393-5392bfe2ea7c 36987-1798 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1799_134fa1e6-4218-4138-b3e8-50dbbbe2e42a 36987-1799 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1800_c78e08bb-dbe9-40a7-92d5-c9c5d0403765 36987-1800 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1801_cb84ead7-2044-4cda-8f02-0da04fa5fff4 36987-1801 HUMAN PRESCRIPTION DRUG Cockroach American Cockroach American INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH PERIPLANETA AMERICANA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1802_d776fd84-c01f-4483-9146-5d715e675716 36987-1802 HUMAN PRESCRIPTION DRUG Dog Flea Dog Flea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CTENOCEPHALIDES CANIS .01 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1803_d776fd84-c01f-4483-9146-5d715e675716 36987-1803 HUMAN PRESCRIPTION DRUG Dog Flea Dog Flea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CTENOCEPHALIDES CANIS .01 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1804_72ccd3a1-bbd2-46cc-8bb6-970a8a2f1874 36987-1804 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1805_f243b580-e924-4bc5-9214-b3dfdf50a0a5 36987-1805 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1806_5a479ad2-b047-43df-a87a-e6d227a0ca2f 36987-1806 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1807_b867c176-bd24-4801-a83d-6ffe9619374a 36987-1807 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1808_0dfdf82e-c929-42cd-8393-5392bfe2ea7c 36987-1808 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1809_134fa1e6-4218-4138-b3e8-50dbbbe2e42a 36987-1809 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1810_c78e08bb-dbe9-40a7-92d5-c9c5d0403765 36987-1810 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1811_cb84ead7-2044-4cda-8f02-0da04fa5fff4 36987-1811 HUMAN PRESCRIPTION DRUG Horse Fly Horse Fly INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUSCA DOMESTICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1812_72ccd3a1-bbd2-46cc-8bb6-970a8a2f1874 36987-1812 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1813_f243b580-e924-4bc5-9214-b3dfdf50a0a5 36987-1813 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1814_5a479ad2-b047-43df-a87a-e6d227a0ca2f 36987-1814 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1815_b867c176-bd24-4801-a83d-6ffe9619374a 36987-1815 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1816_0dfdf82e-c929-42cd-8393-5392bfe2ea7c 36987-1816 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1817_134fa1e6-4218-4138-b3e8-50dbbbe2e42a 36987-1817 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1818_c78e08bb-dbe9-40a7-92d5-c9c5d0403765 36987-1818 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1819_cb84ead7-2044-4cda-8f02-0da04fa5fff4 36987-1819 HUMAN PRESCRIPTION DRUG Mosquito Mosquito INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AEDES TAENIORHYNCHUS .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1836_72ccd3a1-bbd2-46cc-8bb6-970a8a2f1874 36987-1836 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1837_f243b580-e924-4bc5-9214-b3dfdf50a0a5 36987-1837 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA 10000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1838_5a479ad2-b047-43df-a87a-e6d227a0ca2f 36987-1838 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1839_b867c176-bd24-4801-a83d-6ffe9619374a 36987-1839 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA 20000 [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1840_0dfdf82e-c929-42cd-8393-5392bfe2ea7c 36987-1840 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1841_134fa1e6-4218-4138-b3e8-50dbbbe2e42a 36987-1841 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1842_c78e08bb-dbe9-40a7-92d5-c9c5d0403765 36987-1842 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1843_cb84ead7-2044-4cda-8f02-0da04fa5fff4 36987-1843 HUMAN PRESCRIPTION DRUG German Cockroach German Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLERGENIC EXTRACT- COCKROACH, GERMAN BLATELLA GERMANICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1844_c8129b8e-5759-459a-bbc3-02830cadb059 36987-1844 HUMAN PRESCRIPTION DRUG Standardized Mite Dermatophagoides farinae Standardized Mite Dermatophagoides farinae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19870612 BLA BLA102193 Nelco Laboratories, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1845_c8129b8e-5759-459a-bbc3-02830cadb059 36987-1845 HUMAN PRESCRIPTION DRUG Standardized Mite Dermatophagoides pteronyssinus Standardized Mite Dermatophagoides pteronyssinus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19900222 BLA BLA102194 Nelco Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1846_d776fd84-c01f-4483-9146-5d715e675716 36987-1846 HUMAN PRESCRIPTION DRUG Cat Flea Cat Flea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CTENOCEPHALIDES FELIS .01 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1847_d776fd84-c01f-4483-9146-5d715e675716 36987-1847 HUMAN PRESCRIPTION DRUG Cat Flea Cat Flea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CTENOCEPHALIDES FELIS .01 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1848_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1848 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1849_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1849 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1850_0dbb0652-e487-4678-a747-b379f75821dc 36987-1850 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1851_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1851 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1852_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1852 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1853_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1853 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1854_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1854 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1855_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1855 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1856_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1856 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1857_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1857 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1858_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1858 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1859_0dbb0652-e487-4678-a747-b379f75821dc 36987-1859 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1860_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1860 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1861_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1861 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1862_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1862 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1863_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1863 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1864_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1864 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1865_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1865 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1866_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1866 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1867_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1867 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1868_0dbb0652-e487-4678-a747-b379f75821dc 36987-1868 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1869_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1869 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1870_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1870 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1871_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1871 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1872_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1872 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1873_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1873 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1874_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1874 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS FLAVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1875_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1875 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1876_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1876 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1877_0dbb0652-e487-4678-a747-b379f75821dc 36987-1877 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1878_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1878 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1879_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1879 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1880_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1880 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1881_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1881 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1882_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1882 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1883_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1883 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUROTIUM HERBARIORUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1884_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1884 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1885_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1885 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1886_0dbb0652-e487-4678-a747-b379f75821dc 36987-1886 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1887_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1887 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1888_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1888 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1889_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1889 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1890_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1890 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1891_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1891 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1892_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1892 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1893_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1893 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1894_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1894 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1895_0dbb0652-e487-4678-a747-b379f75821dc 36987-1895 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1896_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1896 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1897_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1897 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1898_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1898 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1899_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1899 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1900_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1900 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1901_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1901 HUMAN PRESCRIPTION DRUG Aspergillus terreus Aspergillus terreus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ASPERGILLUS TERREUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1902_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1902 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1903_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1903 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1904_0dbb0652-e487-4678-a747-b379f75821dc 36987-1904 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1905_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1905 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1906_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1906 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1907_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1907 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1908_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1908 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1909_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1909 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1910_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1910 HUMAN PRESCRIPTION DRUG Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1911_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1911 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS 10000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1912_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1912 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS 10000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1913_0dbb0652-e487-4678-a747-b379f75821dc 36987-1913 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS 20000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1914_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1914 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS 20000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1915_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1915 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS 40000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1916_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1916 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS .05 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1917_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1917 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS .05 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1918_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1918 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS .1 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1919_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1919 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CANDIDA ALBICANS .1 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 36987-1920_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1920 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1921_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1921 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1922_0dbb0652-e487-4678-a747-b379f75821dc 36987-1922 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1923_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1923 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1924_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1924 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1925_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1925 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1926_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1926 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1927_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1927 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1928_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1928 HUMAN PRESCRIPTION DRUG Acremonium strictum Acremonium strictum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACREMONIUM STRICTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1929_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1929 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1930_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1930 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1931_0dbb0652-e487-4678-a747-b379f75821dc 36987-1931 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1932_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1932 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1933_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1933 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1934_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1934 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1935_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1935 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1936_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1936 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1937_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1937 HUMAN PRESCRIPTION DRUG Trichothecium roseum Trichothecium roseum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOTHECIUM ROSEUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1938_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1938 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1939_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1939 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1940_0dbb0652-e487-4678-a747-b379f75821dc 36987-1940 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1941_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1941 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1942_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1942 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1943_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1943 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1944_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1944 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1945_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1945 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1946_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1946 HUMAN PRESCRIPTION DRUG Cladosporium cladosporioides Cladosporium cladosporioides INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1947_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1947 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1948_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1948 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1949_0dbb0652-e487-4678-a747-b379f75821dc 36987-1949 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1950_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1950 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1951_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1951 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1952_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1952 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1953_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1953 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1954_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1954 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1955_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1955 HUMAN PRESCRIPTION DRUG Chaetomium globosum Chaetomium globosum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHAETOMIUM GLOBOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1956_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1956 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1957_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1957 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1958_0dbb0652-e487-4678-a747-b379f75821dc 36987-1958 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1959_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1959 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1960_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1960 HUMAN PRESCRIPTION DRUG Curvularia inaequalis Curvularia inaequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1961_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1961 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1962_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1962 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1963_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1963 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1964_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1964 HUMAN PRESCRIPTION DRUG Curvularia inequalis Curvularia inequalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CURVULARIA INAEQUALIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1965_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1965 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM 10000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-1966_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1966 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM 10000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-1967_0dbb0652-e487-4678-a747-b379f75821dc 36987-1967 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM 20000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-1968_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1968 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM 20000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-1969_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1969 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM 40000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-1970_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1970 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM .05 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-1971_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1971 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM .05 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-1972_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1972 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-1973_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1973 HUMAN PRESCRIPTION DRUG Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-1974_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1974 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1975_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1975 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1976_0dbb0652-e487-4678-a747-b379f75821dc 36987-1976 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1977_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1977 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1978_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1978 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1979_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1979 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1980_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1980 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1981_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1981 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1982_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1982 HUMAN PRESCRIPTION DRUG Fusarium compactum Fusarium compactum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FUSARIUM COMPACTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1983_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1983 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1984_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1984 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1985_0dbb0652-e487-4678-a747-b379f75821dc 36987-1985 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1986_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1986 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1987_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1987 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1988_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1988 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1989_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1989 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1990_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1990 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1991_d12744f1-9486-4d31-b57b-38009e772ed7 36987-1991 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. GEOTRICHUM CANDIDUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1992_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-1992 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1993_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-1993 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1994_0dbb0652-e487-4678-a747-b379f75821dc 36987-1994 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1995_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-1995 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1996_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-1996 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1997_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-1997 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1998_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-1998 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-1999_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-1999 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2000_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2000 HUMAN PRESCRIPTION DRUG Bipolaris sorokiniana Bipolaris sorokiniana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COCHLIOBOLUS SATIVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2001_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2001 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2002_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2002 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2003_0dbb0652-e487-4678-a747-b379f75821dc 36987-2003 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2004_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2004 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2005_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2005 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2006_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2006 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2007_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2007 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2008_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2008 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2009_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2009 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MUCOR PLUMBEUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2010_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2010 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2011_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2011 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2012_0dbb0652-e487-4678-a747-b379f75821dc 36987-2012 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2013_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2013 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2014_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2014 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2015_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2015 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2016_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2016 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2017_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2017 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2018_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2018 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. NEUROSPORA INTERMEDIA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2019_df67ce4b-b36a-4b3b-a1dc-0f6f00661092 36987-2019 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2020_65e63469-f7b2-41e0-b3ab-af471b6b5542 36987-2020 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2021_e1e95062-bc51-41aa-9192-7fcbf93be13a 36987-2021 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2022_23e797dd-af20-4ed3-8c4d-eed59804742e 36987-2022 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2023_27ad9add-410a-42cc-b48c-b1e3a043aacf 36987-2023 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2024_763b329a-87a0-400e-ba56-92c31959599f 36987-2024 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2025_977f6afc-d125-43a5-94fa-c278dbb2a166 36987-2025 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2026_c8059bfd-f6a0-47c0-9c2f-7673975b4f6e 36987-2026 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora shaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2027_333d60d2-2a8c-4a82-922b-490696e55e89 36987-2027 HUMAN PRESCRIPTION DRUG Nigrospora sphaerica Nigrospora sphaerica INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KHUSKIA ORYZAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2037_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2037 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2038_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2038 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2039_0dbb0652-e487-4678-a747-b379f75821dc 36987-2039 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2040_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2040 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2041_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2041 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2042_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2042 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2043_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2043 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2044_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2044 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2045_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2045 HUMAN PRESCRIPTION DRUG Penicilium chrysogenum Penicilium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2046_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2046 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2047_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2047 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2048_0dbb0652-e487-4678-a747-b379f75821dc 36987-2048 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2049_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2049 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2050_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2050 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2051_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2051 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2052_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2052 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2053_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2053 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2054_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2054 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2055_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2055 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA 10000 [PNU]/mL E 20171231 36987-2056_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2056 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA 10000 [PNU]/mL E 20171231 36987-2057_0dbb0652-e487-4678-a747-b379f75821dc 36987-2057 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA 20000 [PNU]/mL E 20171231 36987-2058_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2058 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA 20000 [PNU]/mL E 20171231 36987-2059_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2059 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA 40000 [PNU]/mL E 20171231 36987-2060_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2060 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA .05 g/mL E 20171231 36987-2061_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2061 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA .05 g/mL E 20171231 36987-2062_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2062 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA .1 g/mL E 20171231 36987-2063_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2063 HUMAN PRESCRIPTION DRUG Phoma glomerata Phoma glomerata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHOMA GLOMERATA .1 g/mL E 20171231 36987-2064_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2064 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2065_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2065 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2066_0dbb0652-e487-4678-a747-b379f75821dc 36987-2066 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2067_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2067 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2068_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2068 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2069_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2069 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2070_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2070 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2071_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2071 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2072_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2072 HUMAN PRESCRIPTION DRUG Aureobasidium pullulans Aureobasidium pullulans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2073_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2073 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2074_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2074 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2075_0dbb0652-e487-4678-a747-b379f75821dc 36987-2075 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2076_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2076 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2077_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2077 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2078_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2078 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2079_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2079 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2080_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2080 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2081_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2081 HUMAN PRESCRIPTION DRUG Rhizopus oryzae Rhizopus oryzae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2082_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2082 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2083_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2083 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2084_0dbb0652-e487-4678-a747-b379f75821dc 36987-2084 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2085_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2085 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2086_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2086 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2087_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2087 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2088_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2088 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2089_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2089 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2090_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2090 HUMAN PRESCRIPTION DRUG Rhodotorula mucilaginosa Rhodotorula mucilaginosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RHODOTORULA MUCILAGINOSA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2091_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2091 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-2092_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2092 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-2093_0dbb0652-e487-4678-a747-b379f75821dc 36987-2093 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-2094_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2094 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-2095_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2095 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-2096_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2096 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-2097_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2097 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-2098_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2098 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-2099_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2099 HUMAN PRESCRIPTION DRUG Saccharomyces cerevisiae Saccharomyces cerevisiae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SACCHAROMYCES CEREVISIAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 36987-2109_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2109 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2110_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2110 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2111_0dbb0652-e487-4678-a747-b379f75821dc 36987-2111 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2112_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2112 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2113_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2113 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2114_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2114 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2115_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2115 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2116_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2116 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2117_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2117 HUMAN PRESCRIPTION DRUG Stemphylium sarciniforms Stemphylium sarciniforms INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. STEMPHYLIUM SARCINIFORME .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2118_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2118 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2119_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2119 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2120_0dbb0652-e487-4678-a747-b379f75821dc 36987-2120 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2121_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2121 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2122_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2122 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2123_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2123 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2124_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2124 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2125_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2125 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2126_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2126 HUMAN PRESCRIPTION DRUG Trichoderma harzianam Trichoderma harzianam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHODERMA HARZIANUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2127_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2127 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2128_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2128 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2129_0dbb0652-e487-4678-a747-b379f75821dc 36987-2129 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2130_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2130 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2131_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2131 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2132_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2132 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2133_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2133 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2134_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2134 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2135_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2135 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2145_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2145 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2146_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2146 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2147_0dbb0652-e487-4678-a747-b379f75821dc 36987-2147 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2148_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2148 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2149_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2149 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2150_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2150 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2151_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2151 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2152_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2152 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2153_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2153 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO MAYDIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2154_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2154 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2155_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2155 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2156_0dbb0652-e487-4678-a747-b379f75821dc 36987-2156 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2157_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2157 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2158_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2158 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2159_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2159 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2160_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2160 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2161_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2161 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2162_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2162 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO AVENAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2163_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2163 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2164_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2164 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2165_0dbb0652-e487-4678-a747-b379f75821dc 36987-2165 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2166_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2166 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2167_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2167 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2168_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2168 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2169_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2169 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2170_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2170 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2171_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2171 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. USTILAGO TRITICI .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2172_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2172 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2173_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2173 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2174_0dbb0652-e487-4678-a747-b379f75821dc 36987-2174 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2175_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2175 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2176_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2176 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2177_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2177 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2178_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2178 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2179_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2179 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2180_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2180 HUMAN PRESCRIPTION DRUG Wheat Bunt Wheat Bunt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILLETIA CARIES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2181_42de87a6-4ad2-4dd1-ae19-915aec27f42c 36987-2181 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2182_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3 36987-2182 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS 10000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2183_0dbb0652-e487-4678-a747-b379f75821dc 36987-2183 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2184_87be8e36-5ef3-46dc-9497-3254bcf37ec9 36987-2184 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS 20000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2185_9010bf62-c443-49a9-b8f8-fa8dd9223885 36987-2185 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS 40000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2186_3fd958a1-76f3-4d4b-9233-7cf3da1c304b 36987-2186 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2187_c1989e1c-0fcf-475f-9601-72f8c842e9d8 36987-2187 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2188_9ea18f57-b968-4c63-84f4-9e6ae475d10f 36987-2188 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2189_d12744f1-9486-4d31-b57b-38009e772ed7 36987-2189 HUMAN PRESCRIPTION DRUG Wheat Stem Rust Wheat Stem Rust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PUCCINIA GRAMINIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2194_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2194 HUMAN PRESCRIPTION DRUG Cotton Cotton INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON .05 g/mL E 20171231 36987-2195_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2195 HUMAN PRESCRIPTION DRUG Cotton Cotton INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON .05 g/mL E 20171231 36987-2196_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2196 HUMAN PRESCRIPTION DRUG Cotton Cotton INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON .1 g/mL E 20171231 36987-2197_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2197 HUMAN PRESCRIPTION DRUG Cotton Cotton INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON .1 g/mL E 20171231 36987-2202_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2202 HUMAN PRESCRIPTION DRUG Cotton Linters Cotton Linters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2203_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2203 HUMAN PRESCRIPTION DRUG Cotton Linters Cotton Linters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2204_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2204 HUMAN PRESCRIPTION DRUG Cotton Linters Cotton Linters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2205_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2205 HUMAN PRESCRIPTION DRUG Cotton Linters Cotton Linters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2210_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2210 HUMAN PRESCRIPTION DRUG Cotton Seed Cotton Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-2211_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2211 HUMAN PRESCRIPTION DRUG Cotton Seed Cotton Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-2212_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2212 HUMAN PRESCRIPTION DRUG Cotton Seed Cotton Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-2213_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2213 HUMAN PRESCRIPTION DRUG Cotton Seed Cotton Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. COTTON SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-2214_f70401b9-9617-41a7-a0c6-ded6f6efa9fa 36987-2214 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED 10000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-2215_f8ad594a-24c1-4cb6-bf12-f4f6359c4494 36987-2215 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED 10000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-2216_089ffe5f-49a3-4c82-a942-fa4207e7c34c 36987-2216 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED 20000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-2217_de8ac52f-f946-4ae1-a219-362c06931040 36987-2217 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED 20000 [PNU]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-2218_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2218 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-2219_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2219 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-2220_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2220 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-2221_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2221 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FLAX SEED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 36987-2226_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2226 HUMAN PRESCRIPTION DRUG Kapok Kapok INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CEIBA PENTANDRA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2227_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2227 HUMAN PRESCRIPTION DRUG Kapok Kapok INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CEIBA PENTANDRA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2228_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2228 HUMAN PRESCRIPTION DRUG Kapok Kapok INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CEIBA PENTANDRA FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2229_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2229 HUMAN PRESCRIPTION DRUG Kapok Kapok INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CEIBA PENTANDRA FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2234_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2234 HUMAN PRESCRIPTION DRUG Orris Root Orris Root INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .05 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] E 20171231 36987-2235_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2235 HUMAN PRESCRIPTION DRUG Orris Root Orris Root INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .05 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] E 20171231 36987-2236_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2236 HUMAN PRESCRIPTION DRUG Orris Root Orris Root INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .1 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] E 20171231 36987-2237_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2237 HUMAN PRESCRIPTION DRUG Orris Root Orris Root INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .1 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] E 20171231 36987-2238_f70401b9-9617-41a7-a0c6-ded6f6efa9fa 36987-2238 HUMAN PRESCRIPTION DRUG Tobacco Leaf Tobacco Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOBACCO LEAF 10000 [PNU]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-2239_f8ad594a-24c1-4cb6-bf12-f4f6359c4494 36987-2239 HUMAN PRESCRIPTION DRUG Tobacco Leaf Tobacco Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOBACCO LEAF 10000 [PNU]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-2240_089ffe5f-49a3-4c82-a942-fa4207e7c34c 36987-2240 HUMAN PRESCRIPTION DRUG Tobacco Leaf Tobacco Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOBACCO LEAF 20000 [PNU]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-2242_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2242 HUMAN PRESCRIPTION DRUG Tobacco Leaf Tobacco Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOBACCO LEAF .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-2244_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2244 HUMAN PRESCRIPTION DRUG Tobacco Leaf Tobacco Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOBACCO LEAF .025 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-2245_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2245 HUMAN PRESCRIPTION DRUG Tobacco Leaf Tobacco Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TOBACCO LEAF .025 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 36987-2246_f70401b9-9617-41a7-a0c6-ded6f6efa9fa 36987-2246 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER 10000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2247_f8ad594a-24c1-4cb6-bf12-f4f6359c4494 36987-2247 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER 10000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2248_089ffe5f-49a3-4c82-a942-fa4207e7c34c 36987-2248 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER 20000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2249_de8ac52f-f946-4ae1-a219-362c06931040 36987-2249 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER 20000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2250_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2250 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2251_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2251 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2252_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2252 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2253_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2253 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORCORUS CAPSULARIS FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2254_f70401b9-9617-41a7-a0c6-ded6f6efa9fa 36987-2254 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER 10000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2255_f8ad594a-24c1-4cb6-bf12-f4f6359c4494 36987-2255 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER 10000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2256_089ffe5f-49a3-4c82-a942-fa4207e7c34c 36987-2256 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER 20000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2257_de8ac52f-f946-4ae1-a219-362c06931040 36987-2257 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER 20000 [PNU]/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2258_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169 36987-2258 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2259_17b9e66f-a212-49c5-b9da-713086e386e3 36987-2259 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2260_3f71b69c-37b8-4c27-af1a-cc5178f3ff61 36987-2260 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2261_a7d6202e-b1fe-482d-9a96-71ce589f526a 36987-2261 HUMAN PRESCRIPTION DRUG Sisal Sisal INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AGAVE SISALANA FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2262_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2262 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2263_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2263 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2264_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2264 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2265_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2265 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2266_46893e16-0a95-41cc-816f-c05a3a464967 36987-2266 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2267_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2267 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2268_686f64e3-7748-4964-9c12-68dfd082025a 36987-2268 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2269_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2269 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASPALUM NOTATUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2270_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2270 HUMAN PRESCRIPTION DRUG Standardized Bermuda Grass Pollen Standardized Bermuda Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102195 Nelco Laboratories, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2271_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2271 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2272_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2272 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2273_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2273 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2274_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2274 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2275_46893e16-0a95-41cc-816f-c05a3a464967 36987-2275 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2276_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2276 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2277_686f64e3-7748-4964-9c12-68dfd082025a 36987-2277 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2278_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2278 HUMAN PRESCRIPTION DRUG Annual Blue Grass Annual Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA ANNUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2279_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2279 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2280_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2280 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2281_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2281 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2282_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2282 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2283_46893e16-0a95-41cc-816f-c05a3a464967 36987-2283 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2284_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2284 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2285_686f64e3-7748-4964-9c12-68dfd082025a 36987-2285 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2286_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2286 HUMAN PRESCRIPTION DRUG Canadian Blue Grass Canadian Blue Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POA COMPRESSA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2287_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2287 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2288_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2288 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2289_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2289 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2290_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2290 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2291_46893e16-0a95-41cc-816f-c05a3a464967 36987-2291 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2292_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2292 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2293_686f64e3-7748-4964-9c12-68dfd082025a 36987-2293 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2294_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2294 HUMAN PRESCRIPTION DRUG Brome Grass Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2295_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2295 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2296_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2296 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2297_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2297 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2298_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2298 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2299_46893e16-0a95-41cc-816f-c05a3a464967 36987-2299 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2300_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2300 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2301_686f64e3-7748-4964-9c12-68dfd082025a 36987-2301 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2302_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2302 HUMAN PRESCRIPTION DRUG Canary Grass Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2303_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2303 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2304_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2304 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2305_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2305 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2306_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2306 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2307_46893e16-0a95-41cc-816f-c05a3a464967 36987-2307 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2308_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2308 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2309_686f64e3-7748-4964-9c12-68dfd082025a 36987-2309 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2310_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2310 HUMAN PRESCRIPTION DRUG Corn Grass Corn Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ZEA MAYS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2311_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2311 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2312_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2312 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2313_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2313 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2314_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2314 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2315_46893e16-0a95-41cc-816f-c05a3a464967 36987-2315 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2316_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2316 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2317_686f64e3-7748-4964-9c12-68dfd082025a 36987-2317 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2318_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2318 HUMAN PRESCRIPTION DRUG Couch Quack Grass Couch Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2319_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2319 HUMAN PRESCRIPTION DRUG Standardized Meadow Fescue Grass Pollen Standardized Meadow Fescue Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102197 Nelco Laboratories, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2320_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2320 HUMAN PRESCRIPTION DRUG Standardized Meadow Fescue Grass Pollen Standardized Meadow Fescue Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102197 Nelco Laboratories, Inc. FESTUCA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2321_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2321 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2322_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2322 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2323_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2323 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2324_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2324 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2325_46893e16-0a95-41cc-816f-c05a3a464967 36987-2325 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2326_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2326 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2327_686f64e3-7748-4964-9c12-68dfd082025a 36987-2327 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2328_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2328 HUMAN PRESCRIPTION DRUG Grama Grass Grama Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BOUTELOUA GRACILIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2329_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2329 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2330_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2330 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2331_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2331 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2332_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2332 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2333_46893e16-0a95-41cc-816f-c05a3a464967 36987-2333 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2334_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2334 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2335_686f64e3-7748-4964-9c12-68dfd082025a 36987-2335 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2336_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2336 HUMAN PRESCRIPTION DRUG Johnson Grass Johnson Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SORGHUM HALEPENSE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2337_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2337 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2338_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2338 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2339_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2339 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2340_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2340 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2341_46893e16-0a95-41cc-816f-c05a3a464967 36987-2341 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2342_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2342 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2343_686f64e3-7748-4964-9c12-68dfd082025a 36987-2343 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2344_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2344 HUMAN PRESCRIPTION DRUG Cultivated Oat Cultivated Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AVENA SATIVA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2345_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2345 HUMAN PRESCRIPTION DRUG Standardized Orchard Grass Pollen Standardized Orchard Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102198 Nelco Laboratories, Inc. DACTYLIS GLOMERATA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2346_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2346 HUMAN PRESCRIPTION DRUG Standardized Orchard Grass Pollen Standardized Orchard Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102198 Nelco Laboratories, Inc. DACTYLIS GLOMERATA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2347_8b77d740-1dae-42ac-95ec-156c998f7266 36987-2347 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2348_e76475f4-84f5-47f0-9d91-50abb81fbfaa 36987-2348 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2349_4e286c80-4d2a-433b-9ea5-2e7678db4c2f 36987-2349 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2350_5afe0fb9-ffff-4dc2-8f99-2654574c5d57 36987-2350 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2351_07ebc83d-6caa-4f78-a98b-997fc70d9a08 36987-2351 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2352_2e9b7a7b-447e-4e5e-b327-09ceb22e0901 36987-2352 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2353_c4e39aa1-65b2-4426-a5ac-7e6ad761d7b8 36987-2353 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2354_e0e5cad7-f73f-49ca-b0fe-e59630c501fa 36987-2354 HUMAN PRESCRIPTION DRUG Para Grass Pollen Para Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. UROCHLOA MUTICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2355_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2355 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2356_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2356 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2357_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2357 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2358_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2358 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2359_46893e16-0a95-41cc-816f-c05a3a464967 36987-2359 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2360_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2360 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2361_686f64e3-7748-4964-9c12-68dfd082025a 36987-2361 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2362_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2362 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELYMUS REPENS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2363_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2363 HUMAN PRESCRIPTION DRUG Standardized Redtop Grass Pollen Standardized Redtop Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102192 Nelco Laboratories, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2364_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2364 HUMAN PRESCRIPTION DRUG Standardized Redtop Grass Pollen Standardized Redtop Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102192 Nelco Laboratories, Inc. AGROSTIS GIGANTEA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2365_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2365 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2366_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2366 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2367_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2367 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2368_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2368 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2369_46893e16-0a95-41cc-816f-c05a3a464967 36987-2369 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2370_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2370 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2371_686f64e3-7748-4964-9c12-68dfd082025a 36987-2371 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2372_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2372 HUMAN PRESCRIPTION DRUG Cultivated Rye Cultivated Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SECALE CEREALE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2373_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2373 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2374_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2374 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2375_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2375 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2376_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2376 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2377_46893e16-0a95-41cc-816f-c05a3a464967 36987-2377 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2378_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2378 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2379_686f64e3-7748-4964-9c12-68dfd082025a 36987-2379 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2380_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2380 HUMAN PRESCRIPTION DRUG Giant Wild Rye Giant Wild Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LEYMUS CONDENSATUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2381_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2381 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2382_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2382 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2383_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2383 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2384_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2384 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2385_46893e16-0a95-41cc-816f-c05a3a464967 36987-2385 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2386_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2386 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2387_686f64e3-7748-4964-9c12-68dfd082025a 36987-2387 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2388_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2388 HUMAN PRESCRIPTION DRUG Italian Rye Grass Italian Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LOLIUM PERENNE SSP. MULTIFLORUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2389_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2389 HUMAN PRESCRIPTION DRUG Standardized Perennial Rye Grass Pollen Standardized Perennial Rye Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102200 Nelco Laboratories, Inc. LOLIUM PERENNE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2390_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2390 HUMAN PRESCRIPTION DRUG Standardized Perennial Rye Grass Pollen Standardized Perennial Rye Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102200 Nelco Laboratories, Inc. LOLIUM PERENNE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2391_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2391 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2392_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2392 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2393_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2393 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2394_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2394 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2395_46893e16-0a95-41cc-816f-c05a3a464967 36987-2395 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2396_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2396 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2397_686f64e3-7748-4964-9c12-68dfd082025a 36987-2397 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2398_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2398 HUMAN PRESCRIPTION DRUG Salt Grass Salt Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2399_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2399 HUMAN PRESCRIPTION DRUG Standardized Sweet Vernal Grass Pollen Standardized Sweet Vernal Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102201 Nelco Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2400_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2400 HUMAN PRESCRIPTION DRUG Standardized Sweet Vernal Grass Pollen Standardized Sweet Vernal Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102201 Nelco Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2401_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2401 HUMAN PRESCRIPTION DRUG Standardized Timothy Grass Pollen Standardized Timothy Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102202 Nelco Laboratories, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2402_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2402 HUMAN PRESCRIPTION DRUG Standardized Timothy Grass Pollen Standardized Timothy Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102202 Nelco Laboratories, Inc. PHLEUM PRATENSE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2403_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2403 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2404_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2404 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2405_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2405 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2406_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2406 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2407_46893e16-0a95-41cc-816f-c05a3a464967 36987-2407 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2408_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2408 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2409_686f64e3-7748-4964-9c12-68dfd082025a 36987-2409 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2410_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2410 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. DISTICHLIS SPICATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2411_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2411 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2412_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2412 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2413_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2413 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2414_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2414 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2415_46893e16-0a95-41cc-816f-c05a3a464967 36987-2415 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2416_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2416 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2417_686f64e3-7748-4964-9c12-68dfd082025a 36987-2417 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2418_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2418 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TRITICUM AESTIVUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2419_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2419 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2420_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2420 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2421_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2421 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2422_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2422 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2423_46893e16-0a95-41cc-816f-c05a3a464967 36987-2423 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2424_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2424 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2425_686f64e3-7748-4964-9c12-68dfd082025a 36987-2425 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2426_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2426 HUMAN PRESCRIPTION DRUG West Wheat Grass West Wheat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PASCOPYRUM SMITHII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2427_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2427 HUMAN PRESCRIPTION DRUG Standardized Kentucky (June) Bluegrass Pollen Standardized Kentucky (June) Bluegrass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102196 Nelco Laboratories, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2428_1ec687f1-9d85-476a-83e1-59e2bdbeebbc 36987-2428 HUMAN PRESCRIPTION DRUG Standardized Kentucky (June) Bluegrass Pollen Standardized Kentucky (June) Bluegrass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19980210 BLA BLA102196 Nelco Laboratories, Inc. POA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2429_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2429 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2430_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2430 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2431_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2431 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2432_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2432 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2433_46893e16-0a95-41cc-816f-c05a3a464967 36987-2433 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2434_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2434 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2435_686f64e3-7748-4964-9c12-68dfd082025a 36987-2435 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2436_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2436 HUMAN PRESCRIPTION DRUG Soft Cheat Brome Soft Cheat Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2437_43e1cd4a-c8eb-4acd-bee8-f61ab9b5cdac 36987-2437 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2438_5efa434d-c520-47eb-8524-f97ccebad6fc 36987-2438 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2439_467064a9-eca5-4b65-bdbb-0323fb27bcf6 36987-2439 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2440_19424a5a-5a7a-4ee6-bc1e-f6fce765f047 36987-2440 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2441_46893e16-0a95-41cc-816f-c05a3a464967 36987-2441 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2442_72e454d7-3ef9-4e04-bd95-d894fab0b155 36987-2442 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2443_686f64e3-7748-4964-9c12-68dfd082025a 36987-2443 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2444_b28ad23e-222c-49fb-8631-a50fe06898eb 36987-2444 HUMAN PRESCRIPTION DRUG Smooth Brome Smooth Brome INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROMUS INERMIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2445_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2445 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2446_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2446 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2447_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2447 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2448_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2448 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2449_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2449 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2450_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2450 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2451_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2451 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2452_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2452 HUMAN PRESCRIPTION DRUG Acacia Acacia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACACIA BAILEYANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2453_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2453 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2454_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2454 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2455_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2455 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2456_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2456 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2457_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2457 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2458_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2458 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2459_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2459 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2460_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2460 HUMAN PRESCRIPTION DRUG Red Alder Red Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RUBRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2461_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2461 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2462_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2462 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2463_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2463 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2464_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2464 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2465_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2465 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2466_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2466 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2467_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2467 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2468_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2468 HUMAN PRESCRIPTION DRUG Tag Alder Tag Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2469_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2469 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2470_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2470 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2471_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2471 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2472_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2472 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2473_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2473 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2474_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2474 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2475_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2475 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2476_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2476 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2477_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2477 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2478_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2478 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2479_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2479 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2480_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2480 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2481_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2481 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2482_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2482 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2483_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2483 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2484_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2484 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS VELUTINA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2485_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2485 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2486_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2486 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2487_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2487 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2488_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2488 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2489_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2489 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2490_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2490 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2491_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2491 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2492_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2492 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2493_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2493 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2494_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2494 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2495_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2495 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2496_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2496 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2497_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2497 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2498_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2498 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2499_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2499 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2500_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2500 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FRAXINUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2501_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2501 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2502_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2502 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2503_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2503 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2504_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2504 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2505_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2505 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2506_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2506 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2507_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2507 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2508_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2508 HUMAN PRESCRIPTION DRUG Aspen Aspen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS TREMULOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2509_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2509 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2510_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2510 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2511_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2511 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2512_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2512 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2513_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2513 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2514_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2514 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2515_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2515 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2516_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2516 HUMAN PRESCRIPTION DRUG Bayberry Bayberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORELLA CERIFERA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2517_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2517 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2518_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2518 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2519_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2519 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2520_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2520 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2521_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2521 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2522_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2522 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2523_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2523 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2524_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2524 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2525_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2525 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2526_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2526 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2527_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2527 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2528_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2528 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2529_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2529 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2530_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2530 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2531_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2531 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2532_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2532 HUMAN PRESCRIPTION DRUG Beefwood/Australian Pine Beefwood/Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2533_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2533 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2534_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2534 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2535_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2535 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2536_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2536 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2537_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2537 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2538_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2538 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2539_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2539 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2540_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2540 HUMAN PRESCRIPTION DRUG Birch Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2541_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2541 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2542_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2542 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2543_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2543 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2544_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2544 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2545_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2545 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2546_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2546 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2547_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2547 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2548_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2548 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA LENTA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2549_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2549 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2550_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2550 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2551_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2551 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2552_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2552 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2553_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2553 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2554_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2554 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2555_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2555 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2556_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2556 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BETULA POPULIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2557_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2557 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2558_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2558 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2559_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2559 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2560_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2560 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2561_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2561 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2562_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2562 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2563_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2563 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2564_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2564 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER NEGUNDO POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2565_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2565 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2566_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2566 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2567_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2567 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2568_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2568 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2569_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2569 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2570_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2570 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2571_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2571 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2572_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2572 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS ASHEI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2573_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2573 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2574_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2574 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2575_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2575 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2576_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2576 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2577_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2577 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2578_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2578 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2579_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2579 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2580_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2580 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2581_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2581 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2582_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2582 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2583_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2583 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2584_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2584 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2585_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2585 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2586_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2586 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2587_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2587 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2588_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2588 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAMARIX GALLICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2589_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2589 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2590_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2590 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2591_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2591 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2592_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2592 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2593_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2593 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2594_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2594 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2595_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2595 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2596_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2596 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2597_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2597 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2598_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2598 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2599_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2599 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2600_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2600 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2601_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2601 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2602_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2602 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2603_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2603 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2604_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2604 HUMAN PRESCRIPTION DRUG Fremont Cottonwood Fremont Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS FREMONTII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2605_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2605 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2606_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2606 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2607_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2607 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2608_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2608 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2609_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2609 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2610_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2610 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2611_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2611 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2612_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2612 HUMAN PRESCRIPTION DRUG West Cottonwood West Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2613_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2613 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2614_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2614 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2615_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2615 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2616_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2616 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2617_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2617 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2618_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2618 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2619_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2619 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2620_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2620 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2621_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2621 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2622_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2622 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2623_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2623 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2624_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2624 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2625_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2625 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2626_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2626 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2627_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2627 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2628_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2628 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TAXODIUM DISTICHUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2629_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2629 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2630_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2630 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2631_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2631 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2632_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2632 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2633_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2633 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2634_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2634 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2635_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2635 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2636_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2636 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2637_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2637 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2638_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2638 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2639_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2639 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2640_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2640 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2641_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2641 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2642_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2642 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2643_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2643 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2644_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2644 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2645_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2645 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2646_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2646 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2647_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2647 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2648_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2648 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2649_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2649 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2650_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2650 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2651_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2651 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2652_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2652 HUMAN PRESCRIPTION DRUG Chinese Elm Chinese Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ULMUS PUMILA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2653_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2653 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2654_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2654 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2655_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2655 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2656_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2656 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2657_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2657 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2658_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2658 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2659_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2659 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2660_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2660 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2661_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2661 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2662_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2662 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2663_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2663 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2664_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2664 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2665_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2665 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2666_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2666 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2667_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2667 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2668_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2668 HUMAN PRESCRIPTION DRUG Hazelnut Hazelnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CORYLUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2669_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2669 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2670_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2670 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2671_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2671 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2672_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2672 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2673_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2673 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2674_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2674 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2675_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2675 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2676_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2676 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA OVATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2677_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2677 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2678_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2678 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2679_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2679 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2680_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2680 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2681_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2681 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2682_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2682 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2683_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2683 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2684_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2684 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2685_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2685 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2686_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2686 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2687_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2687 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2688_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2688 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2689_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2689 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2690_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2690 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2691_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2691 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2692_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2692 HUMAN PRESCRIPTION DRUG One Seed Juniper One Seed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2693_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2693 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2694_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2694 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2695_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2695 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2696_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2696 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2697_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2697 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2698_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2698 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2699_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2699 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2700_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2700 HUMAN PRESCRIPTION DRUG Pinchot Juniper Pinchot Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2701_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2701 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2702_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2702 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2703_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2703 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2704_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2704 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2705_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2705 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2706_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2706 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2707_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2707 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2708_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2708 HUMAN PRESCRIPTION DRUG Rocky Mountain Juniper Rocky Mountain Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2709_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2709 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2710_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2710 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2711_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2711 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2712_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2712 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2713_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2713 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2714_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2714 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2715_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2715 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2716_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2716 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2717_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2717 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2718_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2718 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2719_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2719 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2720_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2720 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2721_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2721 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2722_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2722 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2723_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2723 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2724_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2724 HUMAN PRESCRIPTION DRUG Western Juniper Western Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2725_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2725 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2726_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2726 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2727_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2727 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2728_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2728 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2729_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2729 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2730_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2730 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2731_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2731 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2732_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2732 HUMAN PRESCRIPTION DRUG Linden Linden INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TILIA AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2733_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2733 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2734_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2734 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2735_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2735 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2736_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2736 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2737_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2737 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2738_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2738 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2739_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2739 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2740_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2740 HUMAN PRESCRIPTION DRUG Black Locust Black Locust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2741_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2741 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN 10000 [PNU]/mL E 20171231 36987-2742_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2742 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN 10000 [PNU]/mL E 20171231 36987-2743_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2743 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN 20000 [PNU]/mL E 20171231 36987-2744_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2744 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN 20000 [PNU]/mL E 20171231 36987-2745_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2745 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN 40000 [PNU]/mL E 20171231 36987-2746_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2746 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN .05 g/mL E 20171231 36987-2747_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2747 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN .05 g/mL E 20171231 36987-2748_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2748 HUMAN PRESCRIPTION DRUG Mango Blossom Mango Blossom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MANGIFERA INDICA POLLEN .1 g/mL E 20171231 36987-2749_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2749 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN 10000 [PNU]/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-2750_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2750 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN 10000 [PNU]/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-2751_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2751 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN 20000 [PNU]/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-2752_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2752 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN 20000 [PNU]/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-2753_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2753 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN 40000 [PNU]/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-2754_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2754 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN .05 g/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-2755_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2755 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN .05 g/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-2756_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2756 HUMAN PRESCRIPTION DRUG Coast Maple Coast Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER MACROPHYLLUM POLLEN .1 g/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 36987-2757_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2757 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2758_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2758 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2759_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2759 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2760_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2760 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2761_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2761 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2762_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2762 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2763_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2763 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2764_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2764 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER RUBRUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2765_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2765 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2766_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2766 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2767_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2767 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2768_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2768 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2769_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2769 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2770_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2770 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2771_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2771 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2772_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2772 HUMAN PRESCRIPTION DRUG Silver Maple Silver Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARINUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2773_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2773 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2774_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2774 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2775_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2775 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2776_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2776 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2777_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2777 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2778_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2778 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2779_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2779 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2780_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2780 HUMAN PRESCRIPTION DRUG Sugar Maple Sugar Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ACER SACCHARUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2781_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2781 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2782_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2782 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2783_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2783 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2784_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2784 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2785_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2785 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2786_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2786 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2787_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2787 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2788_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2788 HUMAN PRESCRIPTION DRUG Melaleuca Pollen Melaleuca Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2789_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2789 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2790_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2790 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2791_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2791 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2792_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2792 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2793_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2793 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2794_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2794 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2795_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2795 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2796_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2796 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PROSOPIS JULIFLORA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2797_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2797 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2798_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2798 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2799_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2799 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2800_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2800 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2801_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2801 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2802_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2802 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2803_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2803 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2804_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2804 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2805_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2805 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2806_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2806 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2807_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2807 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2808_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2808 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2809_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2809 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2810_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2810 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2811_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2811 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2812_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2812 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. MORUS RUBRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2813_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2813 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2814_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2814 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2815_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2815 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2816_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2816 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2817_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2817 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2818_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2818 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2819_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2819 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2820_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2820 HUMAN PRESCRIPTION DRUG Mulberry Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2821_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2821 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2822_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2822 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2823_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2823 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2824_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2824 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2825_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2825 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2826_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2826 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2827_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2827 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2828_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2828 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VELUTINA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2829_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2829 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2830_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2830 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2831_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2831 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2832_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2832 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2833_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2833 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2834_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2834 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2835_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2835 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2836_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2836 HUMAN PRESCRIPTION DRUG Burr Oak Burr Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS MACROCARPA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2837_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2837 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2838_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2838 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2839_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2839 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2840_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2840 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2841_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2841 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2842_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2842 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2843_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2843 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2844_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2844 HUMAN PRESCRIPTION DRUG California Black Oak California Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS KELLOGGII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2845_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2845 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2846_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2846 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2847_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2847 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2848_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2848 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2849_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2849 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2850_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2850 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2851_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2851 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2852_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2852 HUMAN PRESCRIPTION DRUG California Live Oak California Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2853_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2853 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2854_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2854 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2855_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2855 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2856_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2856 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2857_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2857 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2858_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2858 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2859_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2859 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2860_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2860 HUMAN PRESCRIPTION DRUG Gambil Oak Gambil Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS GAMBELII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2861_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2861 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2862_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2862 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2863_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2863 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2864_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2864 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2865_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2865 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2866_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2866 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2867_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2867 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2868_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2868 HUMAN PRESCRIPTION DRUG Red Oak Red Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS RUBRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2869_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2869 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2870_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2870 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2871_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2871 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2872_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2872 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2873_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2873 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2874_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2874 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2875_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2875 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2876_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2876 HUMAN PRESCRIPTION DRUG California Valley White Oak California Valley White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS LOBATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2877_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2877 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2878_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2878 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2879_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2879 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2880_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2880 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2881_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2881 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2882_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2882 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2883_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2883 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2884_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2884 HUMAN PRESCRIPTION DRUG Virginia Live Oak Virginia Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2885_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2885 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2886_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2886 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2887_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2887 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2888_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2888 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2889_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2889 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2890_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2890 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2891_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2891 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2892_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2892 HUMAN PRESCRIPTION DRUG Water Oak Water Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2893_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2893 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2894_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2894 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2895_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2895 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2896_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2896 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2897_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2897 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2898_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2898 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2899_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2899 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2900_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2900 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. QUERCUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2901_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2901 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2902_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2902 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2903_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2903 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2904_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2904 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2905_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2905 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2906_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2906 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2907_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2907 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2908_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2908 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. OLEA EUROPAEA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2909_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2909 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2910_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2910 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2911_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2911 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2912_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2912 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2913_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2913 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2914_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2914 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2915_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2915 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2916_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2916 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CITRUS SINENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2917_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2917 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2918_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2918 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2919_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2919 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2920_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2920 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2921_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2921 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2922_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2922 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2923_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2923 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2924_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2924 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2925_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2925 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2926_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2926 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2927_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2927 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2928_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2928 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2929_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2929 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2930_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2930 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2931_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2931 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2932_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2932 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2933_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2933 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2934_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2934 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2935_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2935 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2936_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2936 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2937_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2937 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2938_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2938 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2939_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2939 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2940_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2940 HUMAN PRESCRIPTION DRUG Pepper Tree Pollen Pepper Tree Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091204 BLA BLA102192 Nelco Laboratories, Inc. SCHINUS MOLLE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2941_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2941 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2942_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2942 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2943_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2943 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2944_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2944 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2945_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2945 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2946_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2946 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2947_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2947 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2948_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2948 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS TAEDA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2949_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2949 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2950_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2950 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2951_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2951 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2952_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2952 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2953_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2953 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2954_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2954 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2955_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2955 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2956_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2956 HUMAN PRESCRIPTION DRUG Longleaf Pine Longleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PALUSTRIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2957_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2957 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2958_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2958 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2959_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2959 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2960_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2960 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2961_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2961 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2962_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2962 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2963_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2963 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2964_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2964 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS PONDEROSA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2965_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2965 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2966_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2966 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2967_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2967 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2968_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2968 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2969_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2969 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2970_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2970 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2971_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2971 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2972_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2972 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ELLIOTTII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2973_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2973 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2974_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2974 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2975_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2975 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2976_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2976 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2977_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2977 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2978_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2978 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2979_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2979 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2980_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2980 HUMAN PRESCRIPTION DRUG Scrub Pine Scrub Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2981_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2981 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2982_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2982 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2983_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2983 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2984_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2984 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2985_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2985 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2986_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2986 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2987_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2987 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2988_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2988 HUMAN PRESCRIPTION DRUG White Pine White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS STROBUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2989_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2989 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2990_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2990 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2991_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2991 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2992_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-2992 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2993_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-2993 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2994_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-2994 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2995_f24271d4-4949-4a67-80d1-62f5885e9407 36987-2995 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2996_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-2996 HUMAN PRESCRIPTION DRUG Western White Pine Western White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS MONTICOLA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2997_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-2997 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2998_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-2998 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-2999_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-2999 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3000_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3000 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3001_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3001 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3002_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3002 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3003_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3003 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3004_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3004 HUMAN PRESCRIPTION DRUG Yellow Pine Yellow Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PINUS ECHINATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3005_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3005 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3006_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3006 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3007_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3007 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3008_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3008 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3009_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3009 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3010_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3010 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3011_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3011 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3012_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3012 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3013_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3013 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3014_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3014 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3015_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3015 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3016_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3016 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3017_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3017 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3018_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3018 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3019_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3019 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3020_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3020 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3021_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3021 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3022_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3022 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3023_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3023 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3024_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3024 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3025_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3025 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3026_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3026 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3027_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3027 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3028_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3028 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIGUSTRUM VULGARE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3029_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3029 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3030_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3030 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3031_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3031 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3032_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3032 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3033_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3033 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3034_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3034 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3035_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3035 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3036_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3036 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3037_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3037 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3038_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3038 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3039_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3039 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3040_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3040 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3041_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3041 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3042_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3042 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3043_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3043 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3044_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3044 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3045_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3045 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3046_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3046 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3047_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3047 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3048_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3048 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3049_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3049 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3050_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3050 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3051_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3051 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3052_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3052 HUMAN PRESCRIPTION DRUG East Sycamore East Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3053_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3053 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3054_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3054 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3055_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3055 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3056_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3056 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3057_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3057 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3058_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3058 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3059_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3059 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3060_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3060 HUMAN PRESCRIPTION DRUG West Sycamore West Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLATANUS RACEMOSA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3061_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3061 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3062_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3062 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3063_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3063 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3064_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3064 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3065_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3065 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3066_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3066 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3067_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3067 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3068_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3068 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3069_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3069 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3070_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3070 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3071_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3071 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3072_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3072 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3073_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3073 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3074_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3074 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3075_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3075 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3076_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3076 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS CALIFORNICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3077_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3077 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3078_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3078 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3079_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3079 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3080_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3080 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3081_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3081 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3082_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3082 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3083_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3083 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3084_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3084 HUMAN PRESCRIPTION DRUG English Walnut English Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. JUGLANS REGIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3085_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3085 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN 10000 [PNU]/mL E 20171231 36987-3086_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3086 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN 10000 [PNU]/mL E 20171231 36987-3087_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3087 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN 20000 [PNU]/mL E 20171231 36987-3088_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3088 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN 20000 [PNU]/mL E 20171231 36987-3089_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3089 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN 40000 [PNU]/mL E 20171231 36987-3090_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3090 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN .05 g/mL E 20171231 36987-3091_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3091 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN .05 g/mL E 20171231 36987-3092_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3092 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX NIGRA POLLEN .1 g/mL E 20171231 36987-3093_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3093 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3094_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3094 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3095_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3095 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3096_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3096 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3097_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3097 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3098_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3098 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3099_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3099 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3100_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3100 HUMAN PRESCRIPTION DRUG Arroyo Willow Arroyo Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX LASIOLEPIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3101_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3101 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3102_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3102 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3103_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3103 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3104_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3104 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3105_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3105 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3106_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3106 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3107_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3107 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3108_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3108 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALIX DISCOLOR POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3109_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3109 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3110_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3110 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3111_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3111 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3112_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3112 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3113_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3113 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3114_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3114 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3115_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3115 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3116_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3116 HUMAN PRESCRIPTION DRUG Poplar Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS DELTOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3117_0d62fd2a-d535-41ba-b17b-cf1e1f8b216b 36987-3117 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3118_c0bd3ba3-a5f1-48f1-a8c2-ab5fefa5f5e6 36987-3118 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3119_90c4b6c4-a7f2-4ba8-927c-8440e0df96f5 36987-3119 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3120_e928d8e4-c564-4a56-b4b3-bd495ef410b6 36987-3120 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3121_2a72f629-5585-48e0-bd3f-7804035e57fb 36987-3121 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3122_ca9dfb3b-60b5-4a0b-83ff-990c5959c205 36987-3122 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3123_f24271d4-4949-4a67-80d1-62f5885e9407 36987-3123 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3124_69cd05e6-a993-428b-9b0c-0235126ba63b 36987-3124 HUMAN PRESCRIPTION DRUG Balsam Poplar Balsam Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3125_45a21265-75ff-4634-a154-faff541e45d6 36987-3125 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3126_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3126 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3127_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3127 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3128_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3128 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3129_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3129 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3130_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3130 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3131_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3131 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3132_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3132 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. TARAXACUM OFFICINALE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3133_45a21265-75ff-4634-a154-faff541e45d6 36987-3133 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3134_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3134 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3135_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3135 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3136_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3136 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3137_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3137 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3138_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3138 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3139_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3139 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3140_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3140 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3141_45a21265-75ff-4634-a154-faff541e45d6 36987-3141 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3142_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3142 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3143_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3143 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3144_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3144 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3145_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3145 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3146_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3146 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3147_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3147 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3148_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3148 HUMAN PRESCRIPTION DRUG Groundsel Groundsel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3149_45a21265-75ff-4634-a154-faff541e45d6 36987-3149 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3150_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3150 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3151_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3151 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3152_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3152 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3153_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3153 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3154_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3154 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3155_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3155 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3156_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3156 HUMAN PRESCRIPTION DRUG Burrobrush Burrobrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. HYMENOCLEA SALSOLA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3157_45a21265-75ff-4634-a154-faff541e45d6 36987-3157 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3158_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3158 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3159_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3159 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3160_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3160 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3161_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3161 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3162_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3162 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3163_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3163 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3164_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3164 HUMAN PRESCRIPTION DRUG Carelessweed Carelessweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3165_45a21265-75ff-4634-a154-faff541e45d6 36987-3165 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3166_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3166 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3167_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3167 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3168_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3168 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3169_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3169 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3170_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3170 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3171_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3171 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3172_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3172 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3173_45a21265-75ff-4634-a154-faff541e45d6 36987-3173 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 10000 [PNU]/mL E 20171231 36987-3174_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3174 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 10000 [PNU]/mL E 20171231 36987-3175_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3175 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 20000 [PNU]/mL E 20171231 36987-3176_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3176 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 20000 [PNU]/mL E 20171231 36987-3177_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3177 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 40000 [PNU]/mL E 20171231 36987-3178_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3178 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN .05 g/mL E 20171231 36987-3179_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3179 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN .05 g/mL E 20171231 36987-3180_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3180 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN .1 g/mL E 20171231 36987-3181_45a21265-75ff-4634-a154-faff541e45d6 36987-3181 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3182_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3182 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3183_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3183 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3184_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3184 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3185_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3185 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3186_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3186 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3187_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3187 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3188_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3188 HUMAN PRESCRIPTION DRUG Curly Dock Curly Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX CRISPUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3189_45a21265-75ff-4634-a154-faff541e45d6 36987-3189 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3190_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3190 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3191_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3191 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3192_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3192 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3193_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3193 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3194_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3194 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3195_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3195 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3196_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3196 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3197_45a21265-75ff-4634-a154-faff541e45d6 36987-3197 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3198_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3198 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3199_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3199 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3200_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3200 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3201_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3201 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3202_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3202 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3203_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3203 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3204_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3204 HUMAN PRESCRIPTION DRUG Firebush/Burning Bush Firebush/Burning Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. KOCHIA SCOPARIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3205_45a21265-75ff-4634-a154-faff541e45d6 36987-3205 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3206_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3206 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3207_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3207 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3208_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3208 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3209_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3209 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3210_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3210 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3211_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3211 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3212_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3212 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3213_45a21265-75ff-4634-a154-faff541e45d6 36987-3213 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3214_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3214 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3215_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3215 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3216_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3216 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3217_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3217 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3218_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3218 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3219_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3219 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3220_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3220 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3221_45a21265-75ff-4634-a154-faff541e45d6 36987-3221 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3222_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3222 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3223_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3223 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3224_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3224 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3225_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3225 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3226_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3226 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3227_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3227 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3228_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3228 HUMAN PRESCRIPTION DRUG Iodine Bush Iodine Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3229_45a21265-75ff-4634-a154-faff541e45d6 36987-3229 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3230_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3230 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3231_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3231 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3232_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3232 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3233_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3233 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3234_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3234 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3235_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3235 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3236_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3236 HUMAN PRESCRIPTION DRUG Lamb Quarters Lamb Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM ALBUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3237_45a21265-75ff-4634-a154-faff541e45d6 36987-3237 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3238_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3238 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3239_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3239 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3240_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3240 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3241_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3241 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3242_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3242 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3243_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3243 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3244_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3244 HUMAN PRESCRIPTION DRUG Lenscale Quailbrush Lenscale Quailbrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3245_45a21265-75ff-4634-a154-faff541e45d6 36987-3245 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3246_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3246 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3247_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3247 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3248_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3248 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3249_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3249 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3250_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3250 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3251_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3251 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3252_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3252 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA XANTHIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3253_45a21265-75ff-4634-a154-faff541e45d6 36987-3253 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3254_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3254 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3255_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3255 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3256_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3256 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3257_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3257 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3258_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3258 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3259_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3259 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3260_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3260 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3261_45a21265-75ff-4634-a154-faff541e45d6 36987-3261 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3262_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3262 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3263_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3263 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3264_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3264 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3265_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3265 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3266_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3266 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3267_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3267 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3268_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3268 HUMAN PRESCRIPTION DRUG Mexican Tea Pollen Mexican Tea Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3269_45a21265-75ff-4634-a154-faff541e45d6 36987-3269 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3270_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3270 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3271_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3271 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3272_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3272 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3273_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3273 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3274_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3274 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3275_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3275 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3276_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3276 HUMAN PRESCRIPTION DRUG Mugwort Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA VULGARIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3277_903c0001-3108-4d4a-af2c-1404cd7a36d7 36987-3277 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3278_afd9ee5b-b6ea-4bde-af79-31cf9b90dabb 36987-3278 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3279_b4cdf699-2588-4332-b27a-e5e744132079 36987-3279 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3280_2ae15a58-71ac-4434-bb4b-cc2fb15e22c0 36987-3280 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3281_93372a13-7c59-413e-8cd6-95e187e54aad 36987-3281 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3282_435dd039-08c8-4e76-902b-d9ca9d4296ce 36987-3282 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3283_f1334005-3717-4445-b780-d545be0be698 36987-3283 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3284_35bbd7c6-95ec-4bc6-8dfc-e902926b7fb6 36987-3284 HUMAN PRESCRIPTION DRUG California Mugwort California Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA DOUGLASIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3285_45a21265-75ff-4634-a154-faff541e45d6 36987-3285 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3286_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3286 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3287_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3287 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3288_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3288 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3289_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3289 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3290_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3290 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3291_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3291 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3292_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3292 HUMAN PRESCRIPTION DRUG Darkleaves Mugwort Darkleaves Mugwort INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3293_45a21265-75ff-4634-a154-faff541e45d6 36987-3293 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3294_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3294 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3295_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3295 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3296_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3296 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3297_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3297 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3298_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3298 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3299_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3299 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3300_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3300 HUMAN PRESCRIPTION DRUG Nettle Nettle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. URTICA DIOICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3301_45a21265-75ff-4634-a154-faff541e45d6 36987-3301 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3302_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3302 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3303_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3303 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3304_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3304 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3305_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3305 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3306_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3306 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3307_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3307 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3308_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3308 HUMAN PRESCRIPTION DRUG Palmers Amaranth Palmers Amaranth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS PALMERI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3309_45a21265-75ff-4634-a154-faff541e45d6 36987-3309 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3310_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3310 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3311_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3311 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3312_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3312 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3313_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3313 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3314_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3314 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3315_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3315 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3316_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3316 HUMAN PRESCRIPTION DRUG Rough Pigweed Rough Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3317_45a21265-75ff-4634-a154-faff541e45d6 36987-3317 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3318_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3318 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3319_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3319 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3320_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3320 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3321_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3321 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3322_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3322 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3323_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3323 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3324_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3324 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3325_45a21265-75ff-4634-a154-faff541e45d6 36987-3325 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3326_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3326 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3327_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3327 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3328_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3328 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3329_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3329 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3330_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3330 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3331_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3331 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3332_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3332 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3333_45a21265-75ff-4634-a154-faff541e45d6 36987-3333 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3334_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3334 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3335_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3335 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3336_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3336 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3337_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3337 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3338_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3338 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3339_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3339 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3340_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3340 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. IVA AXILLARIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3341_45a21265-75ff-4634-a154-faff541e45d6 36987-3341 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3342_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3342 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3343_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3343 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3344_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3344 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3345_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3345 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3346_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3346 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3347_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3347 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3348_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3348 HUMAN PRESCRIPTION DRUG Rabbitbush Rabbitbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3349_45a21265-75ff-4634-a154-faff541e45d6 36987-3349 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3350_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3350 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3351_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3351 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3352_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3352 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3353_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3353 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3354_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3354 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3355_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3355 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3356_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3356 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3357_45a21265-75ff-4634-a154-faff541e45d6 36987-3357 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3358_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3358 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3359_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3359 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3360_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3360 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3361_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3361 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3362_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3362 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3363_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3363 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3364_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3364 HUMAN PRESCRIPTION DRUG Ailanthus Ailanthus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3365_45a21265-75ff-4634-a154-faff541e45d6 36987-3365 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3366_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3366 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3367_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3367 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3368_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3368 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3369_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3369 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3370_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3370 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3371_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3371 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3372_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3372 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3373_45a21265-75ff-4634-a154-faff541e45d6 36987-3373 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3374_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3374 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3375_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3375 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3376_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3376 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3377_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3377 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3378_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3378 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3379_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3379 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3380_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3380 HUMAN PRESCRIPTION DRUG Greasewood Greasewood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3384_afe81254-8c8f-4eb0-a914-81cafe13b7cd 36987-3384 HUMAN PRESCRIPTION DRUG Short Ragweed Pollen Short Ragweed Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19830408 BLA BLA102203 Nelco Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 20000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3385_afe81254-8c8f-4eb0-a914-81cafe13b7cd 36987-3385 HUMAN PRESCRIPTION DRUG Short Ragweed Pollen Short Ragweed Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19830408 BLA BLA102203 Nelco Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 40000 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3387_afe81254-8c8f-4eb0-a914-81cafe13b7cd 36987-3387 HUMAN PRESCRIPTION DRUG Short Ragweed Pollen Short Ragweed Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19830408 BLA BLA102203 Nelco Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN .05 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3388_afe81254-8c8f-4eb0-a914-81cafe13b7cd 36987-3388 HUMAN PRESCRIPTION DRUG Short Ragweed Pollen Short Ragweed Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19830408 BLA BLA102203 Nelco Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN .1 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3389_45a21265-75ff-4634-a154-faff541e45d6 36987-3389 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3390_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3390 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3391_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3391 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3392_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3392 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3393_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3393 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3394_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3394 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3395_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3395 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3396_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3396 HUMAN PRESCRIPTION DRUG Tall Ragweed Tall Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA TRIFIDA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3397_45a21265-75ff-4634-a154-faff541e45d6 36987-3397 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3398_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3398 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3399_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3399 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3400_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3400 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3401_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3401 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3402_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3402 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3403_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3403 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3404_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3404 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. SALSOLA KALI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3405_45a21265-75ff-4634-a154-faff541e45d6 36987-3405 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3406_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3406 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3407_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3407 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3408_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3408 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3409_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3409 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3410_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3410 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3411_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3411 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3412_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3412 HUMAN PRESCRIPTION DRUG Common Sagebrush Common Sagebrush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3413_45a21265-75ff-4634-a154-faff541e45d6 36987-3413 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3414_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3414 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3415_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3415 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3416_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3416 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3417_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3417 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3418_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3418 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3419_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3419 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3420_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3420 HUMAN PRESCRIPTION DRUG Saltbush Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3421_45a21265-75ff-4634-a154-faff541e45d6 36987-3421 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 36987-3422_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3422 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 36987-3423_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3423 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 36987-3424_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3424 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 36987-3425_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3425 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 36987-3426_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3426 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 36987-3427_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3427 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 36987-3428_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3428 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. RUMEX ACETOSELLA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 36987-3429_45a21265-75ff-4634-a154-faff541e45d6 36987-3429 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3430_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3430 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3431_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3431 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3432_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3432 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3433_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3433 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3434_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3434 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3435_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3435 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3436_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3436 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3437_45a21265-75ff-4634-a154-faff541e45d6 36987-3437 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3438_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3438 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3439_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3439 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3440_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3440 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3441_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3441 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3442_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3442 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3443_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3443 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3444_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3444 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ATRIPLEX CANESCENS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3445_45a21265-75ff-4634-a154-faff541e45d6 36987-3445 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3446_50e8afc9-2662-4586-893f-a471fd9f5ee4 36987-3446 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 10000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3447_d152b7aa-b962-4303-9744-c8947edc1d6d 36987-3447 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3448_9e270517-2bc2-4a64-878b-972dfe8eb086 36987-3448 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3449_39113b10-fd1f-4cfc-8432-755a1686fcc4 36987-3449 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3450_c6c9737f-cac3-445a-b895-e2dacca18a0f 36987-3450 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3451_bf187fab-306b-4406-bb41-ad8943ac78bf 36987-3451 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3452_b936d0e6-7b7a-465f-a970-9c600e585844 36987-3452 HUMAN PRESCRIPTION DRUG Wormwood Wormwook INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19720829 BLA BLA102192 Nelco Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 36987-3453_afe81254-8c8f-4eb0-a914-81cafe13b7cd 36987-3453 HUMAN PRESCRIPTION DRUG Short Ragweed Pollen Short Ragweed Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19830408 BLA BLA102203 Nelco Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN .1 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 37000-005_527c05cb-da6e-37fd-e054-00144ff88e88 37000-005 HUMAN OTC DRUG Crest Cavity Protection Regular Sodium Fluoride PASTE, DENTIFRICE DENTAL 19840802 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20191231 37000-006_41fc6c25-996b-6e44-e054-00144ff88e88 37000-006 HUMAN OTC DRUG Crest Pro-Health For Me Anticavity Fluoride Sodium Fluoride RINSE ORAL 20150119 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE .1 mg/mL N 20181231 37000-008_449e5fd2-bfa6-4661-90ce-47aff4e0e7f4 37000-008 HUMAN OTC DRUG Crest Tartar Protection Sodium Fluoride PASTE, DENTIFRICE DENTAL 19921106 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-009_597bab7a-3b56-1083-e053-2a91aa0a9d48 37000-009 HUMAN OTC DRUG Crest Tartar Protection Fresh Mint Gel Sodium Fluoride GEL, DENTIFRICE DENTAL 19950616 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-012_54870807-515a-5e3c-e054-00144ff88e88 37000-012 HUMAN OTC DRUG Crest Pro-Health Stannous Fluoride GEL, DENTIFRICE DENTAL 20160101 20190126 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20181231 37000-014_4403ea0c-d8ae-5d91-e054-00144ff88e88 37000-014 HUMAN OTC DRUG Crest Pro-Health Advanced Active Strengthening Sodium Fluoride RINSE ORAL 20161201 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.2 mg/10mL N 20181231 37000-015_479016ff-1193-46b4-e054-00144ff8d46c 37000-015 HUMAN OTC DRUG Vicks NyQuil HBP Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate LIQUID ORAL 20170201 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 37000-016_43276deb-08fd-0de2-e054-00144ff88e88 37000-016 HUMAN OTC DRUG Pepto-Bismol To Go Bismuth subsalicylate TABLET ORAL 20120301 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 37000-017_4408136f-2e67-0791-e054-00144ff8d46c 37000-017 HUMAN OTC DRUG Pepto-Bismol and Pepto-Bismol To Go Bismuth Subsalicylate KIT 20120917 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company N 20181231 37000-018_42b257e9-f448-32c9-e054-00144ff8d46c 37000-018 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate TABLET ORAL 20040630 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 525 mg/21 N 20181231 37000-019_4407fc2d-0207-40c0-e054-00144ff88e88 37000-019 HUMAN OTC DRUG Pepto-Bismol Max Strength Bismuth subsalicylate LIQUID ORAL 19890331 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 37000-020_597bb284-9ba5-2d9a-e053-2991aa0acb3f 37000-020 HUMAN OTC DRUG Crest Complete Multi-benefit Whitening plus Scope Sodium fluoride PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-022_40ce62b7-df40-16a8-e054-00144ff8d46c 37000-022 HUMAN OTC DRUG Crest Complete Multi-Benefit Whitening Plus Scope Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-023_8d0bdf7b-6d73-4f5f-b824-326ed15b212e 37000-023 HUMAN OTC DRUG Metamucil Therapy for Regularity Psyllium Husk POWDER ORAL 19890331 OTC MONOGRAPH NOT FINAL part334 The Procter & Gamble Manufacturing Company PSYLLIUM HUSK 3.4 g/12g N 20181231 37000-024_594c00aa-c98a-4e6d-840f-2e992e67fb81 37000-024 HUMAN OTC DRUG Metamucil Therapy for regularity Psyllium Husk POWDER ORAL 19941215 OTC MONOGRAPH NOT FINAL part334 The Procter & Gamble Manufacturing Company PSYLLIUM HUSK 3.4 g/5.8g N 20181231 37000-025_47541db7-5350-2d4e-e054-00144ff8d46c 37000-025 HUMAN OTC DRUG Crest Cavity Protection Cool Mint Gel Sodium Fluoride GEL, DENTIFRICE DENTAL 19950616 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-027_4791a561-256c-2edb-e054-00144ff88e88 37000-027 HUMAN OTC DRUG Vicks DayQuil HBP Acetaminophen, Dextromethorphan Hydrobromide CAPSULE, LIQUID FILLED ORAL 20170201 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 325; 10 mg/1; mg/1 N 20181231 37000-028_468c01ff-3bbc-09dd-e054-00144ff8d46c 37000-028 HUMAN OTC DRUG Crest Moisturizing Sodium Fluoride RINSE ORAL 20170110 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE .1 mg/10mL N 20181231 37000-031_415c74b0-cdb8-54bc-e054-00144ff88e88 37000-031 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Cherry Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Doxylamine Succinate KIT ORAL 20130701 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20181231 37000-032_47526445-a05c-4948-e054-00144ff8d46c 37000-032 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate SUSPENSION ORAL 19890331 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 37000-033_416c6674-e4ab-6375-e054-00144ff8d46c 37000-033 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Doxylamine Succinate KIT ORAL 20130801 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20181231 37000-034_416dd077-686b-320c-e054-00144ff8d46c 37000-034 HUMAN OTC DRUG Vicks DayQuil Tropical and Vicks NyQuil Cherry Cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Doxylamine Succinate KIT ORAL 20130801 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20181231 37000-035_41998448-c378-3bcb-e054-00144ff88e88 37000-035 HUMAN OTC DRUG Vicks ZzzQuil Liquid and Liquicaps Combo Diphenhydramine Hydrochloride KIT ORAL 20130501 OTC MONOGRAPH FINAL part338 The Procter & Gamble Manufacturing Company N 20181231 37000-038_4756dfd8-aa22-44eb-e054-00144ff88e88 37000-038 HUMAN OTC DRUG Crest Pro-Health HD Stannous Fluoride KIT 20170130 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company N 20181231 37000-044_40ce4d72-d809-134d-e054-00144ff8d46c 37000-044 HUMAN OTC DRUG Crest Baking Soda and Peroxide Whitening with Tartar Protection Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.6 mg/g N 20181231 37000-045_4147ff00-8e22-7335-e054-00144ff88e88 37000-045 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, and doxylamine succinate KIT 20140731 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20181231 37000-046_47661f42-6dda-4d91-e054-00144ff8d46c 37000-046 HUMAN OTC DRUG Crest 3D White Brilliance Daily Cleansing and Whitening System Stannous Fluoride KIT 20170130 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company N 20181231 37000-049_55de875e-6e65-0366-e054-00144ff8d46c 37000-049 HUMAN OTC DRUG Kids Crest Cavity Protection Sparkle Fun Sodium Fluoride PASTE, DENTIFRICE DENTAL 20020905 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-052_4adb61b3-0488-5810-e054-00144ff8d46c 37000-052 HUMAN OTC DRUG Head and Shoulders Damage Rescue 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20121112 20180304 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-056_44a92ab8-48cb-50b2-e054-00144ff88e88 37000-056 HUMAN OTC DRUG Head and Shoulders 2in1 Men with Old Spice Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20120601 20181221 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-065_42621e1a-cef1-64f5-e054-00144ff8d46c 37000-065 HUMAN OTC DRUG Head and Shoulders Conditioner Dry Scalp Pyrithione Zinc LOTION TOPICAL 20130901 20181120 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 5 mg/mL N 20181231 37000-066_42631ef5-f296-25d2-e054-00144ff8d46c 37000-066 HUMAN OTC DRUG Head and Shoulders Conditioner Itchy Scalp Pyrithione Zinc LOTION TOPICAL 20130901 20181029 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 5 mg/mL N 20181231 37000-067_46de56db-e8ad-7386-e054-00144ff88e88 37000-067 HUMAN OTC DRUG Head and Shoulders Conditioner Smooth and Silky Pyrithione Zinc LOTION TOPICAL 20130901 20181120 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 5 mg/mL N 20181231 37000-068_3a60602b-9d3a-1ef3-e054-00144ff8d46c 37000-068 HUMAN OTC DRUG Head and Shoulders Conditioner Damage Rescue Pyrithione Zinc LOTION TOPICAL 20130901 20180301 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 5 mg/mL N 20181231 37000-069_4302424b-fcbd-1357-e054-00144ff8d46c 37000-069 HUMAN OTC DRUG Head and Shoulders Conditioner Full and Strong Pyrithione Zinc LOTION TOPICAL 20130912 20180826 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 5 mg/mL N 20181231 37000-070_4180c1d6-1ab7-470e-e054-00144ff88e88 37000-070 HUMAN OTC DRUG Head and Shoulders 2in1 Classic Clean Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-071_60a48dc5-0de9-5996-e053-2991aa0a8c77 37000-071 HUMAN OTC DRUG Head and Shoulders Classic Clean Pyrithione Zinc SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-072_60125f56-9d4f-eea7-e053-2991aa0a40a9 37000-072 HUMAN OTC DRUG Head and Shoulders Citrus Breeze Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 20181129 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 10 mg/mL N 20181231 37000-073_431429f8-c508-71c0-e054-00144ff8d46c 37000-073 HUMAN OTC DRUG Head and Shoulders 2in1 Citrus Breeze Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 20180702 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL N 20181231 37000-074_43041d4e-a592-5e22-e054-00144ff88e88 37000-074 HUMAN OTC DRUG Head and Shoulders Purely Gentle Scalp Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL N 20181231 37000-075_430473ba-86d1-0957-e054-00144ff8d46c 37000-075 HUMAN OTC DRUG Head and Shoulders Purely Gentle Scalp Care 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL N 20181231 37000-076_604f4dfb-fa9b-3940-e053-2991aa0aef80 37000-076 HUMAN OTC DRUG Head and Shoulders Ocean Lift 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-077_453520c2-06cc-405b-e054-00144ff88e88 37000-077 HUMAN OTC DRUG Head and Shoulders Green Apple Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-078_6013b3b4-7868-3220-e053-2a91aa0a8e20 37000-078 HUMAN OTC DRUG Head and Shoulders Green Apple 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-079_3f3cf86d-f630-3034-e054-00144ff8d46c 37000-079 HUMAN OTC DRUG Head and Shoulders Itchy Scalp Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-080_53061fde-27db-285a-e054-00144ff88e88 37000-080 HUMAN OTC DRUG Dolce and Gabbana The Foundation Perfect Matte Broadspectrum SPF 20 All shades Ensulizole LIQUID TOPICAL 20121001 20190323 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company ENSULIZOLE 30 mg/mL N 20181231 37000-081_01edeac0-adc1-4959-adb7-5a8e16c82638 37000-081 HUMAN OTC DRUG Head and Shoulders Itchy Scalp 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Co. PYRITHIONE ZINC 1 g/100mL N 20181231 37000-084_3f4b71aa-25c2-31fb-e054-00144ff8d46c 37000-084 HUMAN OTC DRUG Head and Shoulders Men Full and Thick Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-085_6052ce52-e555-6518-e053-2991aa0aaf9d 37000-085 HUMAN OTC DRUG Head and Shoulders Men Full and Thick 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-086_46dedf2c-2674-0f46-e054-00144ff88e88 37000-086 HUMAN OTC DRUG Head and Shoulders Full and Strong Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 20181005 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-087_4ade9577-a0df-12cf-e054-00144ff8d46c 37000-087 HUMAN OTC DRUG Head and Shoulders Full and Strong 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 20180420 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-089_431591d3-9040-3e53-e054-00144ff8d46c 37000-089 HUMAN OTC DRUG Head and Shoulders Men Deep Clean 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 20180810 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-090_44a97998-3fef-52e5-e054-00144ff88e88 37000-090 HUMAN OTC DRUG Head and Shoulders Men Total Care All in 1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 20181203 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-091_42746514-7f0e-4e49-e054-00144ff8d46c 37000-091 HUMAN OTC DRUG Secret Invisible Solid Powder Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20050801 20180629 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g N 20181231 37000-092_6052ebfb-56ea-fe0e-e053-2a91aa0a864a 37000-092 HUMAN OTC DRUG Head and Shoulders Dry Scalp Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-093_4d62a014-ec87-0bc6-e054-00144ff8d46c 37000-093 HUMAN OTC DRUG Head and Shoulders Dry Scalp Care 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-094_5ae3a791-4725-a134-e053-2a91aa0a358b 37000-094 HUMAN OTC DRUG Head and Shoulders Smooth and Silky Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-095_5df99b7b-6f32-90d3-e053-2a91aa0ac625 37000-095 HUMAN OTC DRUG Head and Shoulders Smooth and Silky 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-096_3f61fe01-8a1e-6607-e054-00144ff8d46c 37000-096 HUMAN OTC DRUG Head and Shoulders Men Refresh Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-097_4adf09e9-8a5f-2747-e054-00144ff8d46c 37000-097 HUMAN OTC DRUG Head and Shoulders Men Refresh 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-098_43796c72-2370-4ca8-e054-00144ff8d46c 37000-098 HUMAN OTC DRUG Head and Shoulders Men Active Sport Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 20181031 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-099_4379aba3-c0b9-2500-e054-00144ff88e88 37000-099 HUMAN OTC DRUG Head and Shoulders Men Active Sport 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 20181031 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-100_6053448c-9fc7-b53e-e053-2991aa0a93db 37000-100 HUMAN OTC DRUG Head and Shoulders Ocean Lift Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130901 20190906 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-101_4316efc6-1345-4c84-e054-00144ff88e88 37000-101 HUMAN OTC DRUG Secret Scent Expressions Invisible Solid Ooh-La-La Lavender Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20120101 20181028 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .192 g/g N 20181231 37000-102_44a99bfd-51ab-6555-e054-00144ff88e88 37000-102 HUMAN OTC DRUG Head and Shoulders Men Old Spice Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20131201 20181207 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-106_5e86b957-961a-3876-e053-2991aa0a1bbe 37000-106 HUMAN OTC DRUG Head and Shoulders Dual Sachets Classic Clean Pyrithione Zinc KIT 20130927 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company N 20181231 37000-108_bd37a726-be15-48ec-9202-beb7d66f7e6f 37000-108 HUMAN OTC DRUG Head and Shoulders Dual Sachets Green Apple Pyrithione Zinc KIT 20140127 20180301 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company N 20181231 37000-109_4316fa22-7960-4f2e-e054-00144ff88e88 37000-109 HUMAN OTC DRUG Secret Scent Expressions Clear Cocoa Butter Kiss Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20120101 20181002 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g N 20181231 37000-110_481c081b-8dda-470f-e054-00144ff8d46c 37000-110 HUMAN OTC DRUG Secret Outlast and Olay Smooth Protecting Powder Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130923 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g N 20181231 37000-111_481f433e-098e-5502-e054-00144ff88e88 37000-111 HUMAN OTC DRUG Secret Outlast and Olay Smooth Completely Clean Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130923 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g N 20181231 37000-114_41950333-8913-3b2c-e054-00144ff8d46c 37000-114 HUMAN OTC DRUG Head and Shoulders Dual Sachets Smooth and Silky Pyrithione Zinc KIT 20140127 20180301 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company N 20181231 37000-115_9e31f696-0bf9-4d27-90e3-d14f82d16fb0 37000-115 HUMAN OTC DRUG Head and Shoulders Dual Sachets Full and Strong Pyrithione Zinc KIT 20140127 20180301 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company N 20181231 37000-123_4316fa22-7975-4f2e-e054-00144ff88e88 37000-123 HUMAN OTC DRUG Secret Invisible Bora Bora Fresh Orchid Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20140706 20181008 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 37000-129_531e7c3a-6487-7380-e054-00144ff88e88 37000-129 HUMAN OTC DRUG Secret Antiperspirant/Deodorant Powder Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120201 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .15 g/g N 20181231 37000-131_531f28a1-dc9b-70b4-e054-00144ff8d46c 37000-131 HUMAN OTC DRUG Secret Antiperspirant/Deodorant Shower Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .15 g/g N 20181231 37000-134_531f4afb-4a4f-071d-e054-00144ff8d46c 37000-134 HUMAN OTC DRUG Secret Antiperspirant Powder Fresh Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20070401 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE .24 g/g N 20181231 37000-135_597c82e5-41c9-51fc-e053-2991aa0a8d81 37000-135 HUMAN OTC DRUG Secret Roll-On Powder Fresh ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20010121 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 14 g/100mL N 20181231 37000-136_43276deb-08eb-0de2-e054-00144ff88e88 37000-136 HUMAN OTC DRUG Secret Antiperspirant Spring Breeze Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20070401 20180601 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE .24 g/g N 20181231 37000-141_432787b8-a855-58f6-e054-00144ff8d46c 37000-141 HUMAN OTC DRUG Secret Paris Invisible Romantic Rose Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20140130 20181007 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 37000-142_4327bb6f-4d8d-1a3d-e054-00144ff88e88 37000-142 HUMAN OTC DRUG Secret Hawaii Invisible Citrus Breeze Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20140130 20181004 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 37000-143_6c749f91-620f-466c-bc13-7dfad611d5e4 37000-143 HUMAN OTC DRUG Old Spice Red Zone Collection Swagger Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20140910 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 37000-145_5e07fdda-8898-1b33-e053-2a91aa0a99a5 37000-145 HUMAN OTC DRUG Old Spice Red Zone Collection Swagger Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140910 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g N 20181231 37000-146_428c4154-02ec-0bf3-e054-00144ff88e88 37000-146 HUMAN OTC DRUG Old Spice Fresher Collection Amber with Black Currant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140910 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 37000-147_4299f3fe-c280-5df0-e054-00144ff8d46c 37000-147 HUMAN OTC DRUG Old Spice Fresher Collection Citron with Sandalwood Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140910 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 37000-148_540f7bd3-1930-586b-e054-00144ff8d46c 37000-148 HUMAN OTC DRUG Old Spice Fresher Collection Timber with Mint Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140710 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 37000-151_60b57724-0390-a364-e053-2a91aa0ac5f2 37000-151 HUMAN OTC DRUG Old Spice Wild Collection Bearglove Invisible Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130730 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 37000-152_3b73fe46-aba1-657c-e054-00144ff88e88 37000-152 HUMAN OTC DRUG Old Spice Wild Collection Lionpride Invisible Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130730 20180617 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 37000-153_429c210b-6b7b-0589-e054-00144ff88e88 37000-153 HUMAN OTC DRUG Old Spice Original High Endurance Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140310 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g N 20181231 37000-154_540fa2cb-fe8d-6066-e054-00144ff8d46c 37000-154 HUMAN OTC DRUG Old Spice High Endurance Pure Sport Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120501 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g N 20181231 37000-155_53bf4c52-8644-084e-e054-00144ff88e88 37000-155 HUMAN OTC DRUG Old Spice Wild Collection Wolfthorn Invisible Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20121101 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 37000-156_42895bdb-78dc-4f02-e054-00144ff8d46c 37000-156 HUMAN OTC DRUG Old Spice Wild Collection Hawkridge Invisible Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20121101 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g N 20181231 37000-157_428a74ee-4127-093f-e054-00144ff8d46c 37000-157 HUMAN OTC DRUG Old Spice Wild Collection Foxcrest Invisible Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20121101 20181110 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 37000-158_429d062b-b387-1c19-e054-00144ff88e88 37000-158 HUMAN OTC DRUG Old Spice Fresh High Endurance Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140310 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g N 20181231 37000-162_42a19352-b621-64d7-e054-00144ff8d46c 37000-162 HUMAN OTC DRUG Old Spice High Endurance Clear Pure Sport Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20140917 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 37000-172_5320d9b4-f770-5bfd-e054-00144ff8d46c 37000-172 HUMAN OTC DRUG Secret Invisible Berry Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20150105 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 37000-173_498a4e74-8b23-73cc-e054-00144ff8d46c 37000-173 HUMAN OTC DRUG Secret Australia Eucalyptus Blossom Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20150105 20181228 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 37000-175_43288b5d-bed5-3742-e054-00144ff88e88 37000-175 HUMAN OTC DRUG Secret Invisible Citrus Blossom Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20150105 20181028 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 37000-176_432d36a8-514c-0bab-e054-00144ff8d46c 37000-176 HUMAN OTC DRUG Secret Invisible Solid Shower Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20010101 20180615 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g N 20181231 37000-177_433a636f-4d14-6eeb-e054-00144ff88e88 37000-177 HUMAN OTC DRUG Secret Invisible Solid Spring Breeze Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20010101 20180627 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g N 20181231 37000-178_4379d4f4-ff2e-26df-e054-00144ff88e88 37000-178 HUMAN OTC DRUG Secret Invisible Solid Unscented Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20010101 20180623 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g N 20181231 37000-181_41ff7329-e515-1b54-e054-00144ff8d46c 37000-181 HUMAN OTC DRUG Gillette Clinical Endurance Clear Cool Wave Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20131101 20180209 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .2 g/g N 20181231 37000-182_41fed135-33e0-6e6c-e054-00144ff8d46c 37000-182 HUMAN OTC DRUG Gillette Clinical Sport Clear Power Rush Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20131115 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 20 g/100g N 20181231 37000-184_41fdc26c-ac49-3122-e054-00144ff88e88 37000-184 HUMAN OTC DRUG Gillette Sport Invisible Training Day Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20131127 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 37000-188_60a13c70-31ac-6570-e053-2a91aa0a86fc 37000-188 HUMAN OTC DRUG Gillette Endurance Clear Brisa Tropical Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 20190927 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 37000-189_40438e79-135a-0d09-e054-00144ff8d46c 37000-189 HUMAN OTC DRUG Gillette Clinical Advanced Sport Triumph Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141103 20180720 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 37000-190_8fe6fd19-2500-4b4c-be85-38f1cb810cf3 37000-190 HUMAN OTC DRUG Gillette Endurance Power Beads Cool Wave Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 37000-192_60a177a1-e025-d800-e053-2a91aa0a892d 37000-192 HUMAN OTC DRUG Gillette Sport Power Rush Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 20190824 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 37000-193_60a17f5d-4c32-dafe-e053-2991aa0aca14 37000-193 HUMAN OTC DRUG Gillette Sport Sport Triumph Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 20190812 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 37000-194_60a18f6b-5d65-29af-e053-2a91aa0ab282 37000-194 HUMAN OTC DRUG Gillette Endurance Arctic Ice Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 20190920 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 37000-197_60a19879-c0bf-3c6f-e053-2991aa0adfe0 37000-197 HUMAN OTC DRUG Gillette Endurance Cool Wave Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 20190827 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 37000-198_5d66e878-1a42-5fb8-e053-2991aa0acad2 37000-198 HUMAN OTC DRUG Gillette Sport Undefeated Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20141220 20190813 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 37000-199_1d1a55eb-3402-4d93-8436-d8356d0b4d80 37000-199 HUMAN OTC DRUG Old Spice High Endurance Pure Sport Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20020411 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE .23 g/g N 20181231 37000-206_429d7970-113d-3435-e054-00144ff88e88 37000-206 HUMAN OTC DRUG Old Spice Game Day High Endurance Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140110 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g N 20181231 37000-207_429dbb29-779c-3ec4-e054-00144ff88e88 37000-207 HUMAN OTC DRUG Old Spice Playmaker High Endurance Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140110 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g N 20181231 37000-232_5efb61c9-2353-06a1-e053-2991aa0a20f3 37000-232 HUMAN OTC DRUG Olay Professional ProX Age Repair Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 1.5; 5; 2.6; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 37000-233_d8cd7172-b2aa-44c5-bb38-d4f015b1200b 37000-233 HUMAN OTC DRUG Olay Complete All Day Moisturizer Broad Spectrum SPF 15 Sensitive Octinoxate and Zinc Oxide LOTION TOPICAL 20120501 20180228 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100mL; g/100mL N 20181231 37000-234_69642aea-3faf-4012-a9d7-ff8684f93ef4 37000-234 HUMAN OTC DRUG Olay Age Defying Mature Skin Protective Renewal Broad Spectrum SPF 15 Octinoxate and Zinc Oxide LOTION TOPICAL 20120601 20180411 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100mL; g/100mL N 20181231 37000-249_441a46f0-ecca-4448-e054-00144ff88e88 37000-249 HUMAN OTC DRUG Olay Professional ProX Anti-Oxidant Sheer Daily Moisturizer Broad Spectrum SPF 35 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20121210 20180504 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 9; 4.5; 2.6; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 37000-258_4379ba04-09d0-223f-e054-00144ff88e88 37000-258 HUMAN OTC DRUG Secret Invisible Solid Sheer Clean Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20090101 20181112 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .19 g/g N 20181231 37000-260_44086ee8-d6dc-5150-e054-00144ff88e88 37000-260 HUMAN OTC DRUG Olay Total Effects Moisturizer Plus Serum Duo Fragrance Free Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20121215 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 37000-273_c0799982-cce6-4dda-801e-76ddf3cef887 37000-273 HUMAN OTC DRUG Gillette Odor Shield Invisible Cool Wave Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20121201 20180309 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g N 20181231 37000-275_60a1c32b-70f2-332b-e053-2a91aa0a3fd8 37000-275 HUMAN OTC DRUG Olay Complete All Day Moisture Sensitive with Broad Spectrum SPF 15 Octinoxate and Zinc Oxide CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100g; g/100g N 20181231 37000-281_41459c58-2abf-6781-e054-00144ff8d46c 37000-281 HUMAN OTC DRUG Olay Complete All Day Moisturizer Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120401 20181006 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 3; 5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 37000-283_40cc6501-3cde-24cc-e054-00144ff88e88 37000-283 HUMAN OTC DRUG Olay Regenerist Regenerating Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120601 20181008 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .05; .027; .06 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 37000-284_440957f9-13c2-739b-e054-00144ff88e88 37000-284 HUMAN OTC DRUG Olay Fresh Effects Clear Skin Spot Zinger Salicylic Acid LOTION TOPICAL 20140508 20180301 OTC MONOGRAPH FINAL part333D The Procter & Gamble Manufacturing Company SALICYLIC ACID 2 g/100mL N 20181231 37000-290_433d36c8-71b7-136f-e054-00144ff8d46c 37000-290 HUMAN OTC DRUG Secret Clinical Strength Smooth Fresh Water Orchid ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20110201 20180718 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g N 20181231 37000-292_60a1f016-a64c-5b17-e053-2a91aa0a3e12 37000-292 HUMAN OTC DRUG Olay Total Effects Feather Weight Moisturizer with Sunscreen Broadspectrum SPF 15 Fragrance Free Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 37000-293_44099b7e-40c8-0608-e054-00144ff88e88 37000-293 HUMAN OTC DRUG Olay Fresh Effects Clear Skin Acne Hater Deep Scrub Salicylic Acid LOTION TOPICAL 20140508 20180912 OTC MONOGRAPH FINAL part333D Procter & Gamble Manufacturing Company SALICYLIC ACID 2 g/100mL N 20181231 37000-306_53217611-a5d3-5f27-e054-00144ff88e88 37000-306 HUMAN OTC DRUG Secret Invisible Solid Clean Lavender Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20120101 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g N 20181231 37000-310_437896a9-5b8a-69b9-e054-00144ff88e88 37000-310 HUMAN OTC DRUG Secret Scent Expresssions Invisible Pasion de tango Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20121215 20180922 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .192 g/g N 20181231 37000-319_93da35c0-9175-4ea3-8a04-b56fc1b76414 37000-319 HUMAN OTC DRUG Olay Total Effects Pore Minimizing CC Broadspectrum SPF 15 Light to Medium Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company HOMOSALATE; OCTISALATE; OCTOCRYLENE 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL N 20181231 37000-330_4fb91ca4-deb4-4dc6-e054-00144ff88e88 37000-330 HUMAN OTC DRUG Head and Shoulders Clinical Strength Selenium Sulfide LOTION/SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company SELENIUM SULFIDE 1 g/100mL N 20181231 37000-341_592cb93d-615c-313a-e053-2991aa0aab81 37000-341 HUMAN OTC DRUG Head and Shoulders Instant Relief Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-342_60a20e69-7453-6f35-e053-2991aa0ae3a0 37000-342 HUMAN OTC DRUG Head and Shoulders 2in1 Instant Relief Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-343_4536876f-36d6-6632-e054-00144ff8d46c 37000-343 HUMAN OTC DRUG Head and Shoulders Conditioner Instant Relief Pyrithione Zinc LOTION TOPICAL 20140901 20180817 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 37000-344_4adf09e9-8a6d-2747-e054-00144ff8d46c 37000-344 HUMAN OTC DRUG Head and Shoulders Instant Oil Control Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-345_41d5c9f8-ce7b-5b43-e054-00144ff88e88 37000-345 HUMAN OTC DRUG Head and Shoulders 2in1 Instant Oil Control Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-346_4adf2482-b68f-305c-e054-00144ff8d46c 37000-346 HUMAN OTC DRUG Head and Shoulders Instant Oil Control Conditioner Pyrithione Zinc LOTION TOPICAL 20140901 20180803 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 mg/100mL N 20181231 37000-347_5e1e4369-f5b3-d14f-e053-2991aa0a684c 37000-347 HUMAN OTC DRUG Head and Shoulders Instant Hydration Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 20181107 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20191231 37000-348_5e209c5d-d603-4bb9-e053-2991aa0a1e87 37000-348 HUMAN OTC DRUG Head and Shoulders Instant Hydration 2 in 1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 20190822 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-351_60a37eaf-77db-69a4-e053-2a91aa0a20a2 37000-351 HUMAN OTC DRUG Olay Complete All Day Moisturizer with Sunscreen Broad Spectrum SPF 30 Sensitive Octinoxate, Octisalate, Octocrylene, and Zinc Oxide LOTION TOPICAL 20140821 20181215 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 7.5; 2.5; 2.5; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 37000-352_60a44372-8460-4eda-e053-2a91aa0aa0e3 37000-352 HUMAN OTC DRUG Olay Total Effects Anti-Aging Moisturizer Broad Spectrum SPF 15 Fragrance Free Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 37000-355_437b80ce-8154-38c2-e054-00144ff8d46c 37000-355 HUMAN OTC DRUG Olay Total Effects CC Tone Correcting Broad Spectrum SPF 15 Light to Medium Avobenzone, Octisalate, and Octocrylene CREAM TOPICAL 20131107 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 3; 3 g/mL; g/mL; g/mL N 20181231 37000-356_60a4387c-f314-a80a-e053-2991aa0a4a84 37000-356 HUMAN OTC DRUG Olay Total Effects Anti-Aging Moisturizer Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.6; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 37000-357_601217a7-b276-98dc-e053-2a91aa0ad5c2 37000-357 HUMAN OTC DRUG Olay Regenerist Luminous Brightening and Protecting Moisturizer Broadspectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20140501 20181106 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 37000-362_504aabaf-8df0-2df5-e054-00144ff88e88 37000-362 HUMAN OTC DRUG Secret Clinical Clear Ooh La La Lavender Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20131101 20190328 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .2 g/g N 20181231 37000-363_d1b26d1a-2803-4cee-a8d2-945a8b6a6933 37000-363 HUMAN OTC DRUG Secret Clinical Clear Completely Clean Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20131101 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .2 g/g N 20181231 37000-364_5c79e5d4-e6ac-626a-e053-2a91aa0a12bb 37000-364 HUMAN OTC DRUG Secret Clinical Clear Powder Protection Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20131101 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .2 g/g N 20181231 37000-380_4d636c18-a5b6-3e94-e054-00144ff8d46c 37000-380 HUMAN OTC DRUG Head and Shoulders Moisture Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 37000-381_437c8692-4542-18a0-e054-00144ff88e88 37000-381 HUMAN OTC DRUG Head and Shoulders 2in1 Moisture Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20140901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/mL N 20181231 37000-382_4adf09e1-dd72-217c-e054-00144ff88e88 37000-382 HUMAN OTC DRUG Head and Shoulders Moisture Care Cowash Pyrithione Zinc LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 37000-392_5306c51e-c3b1-3b4f-e054-00144ff88e88 37000-392 HUMAN OTC DRUG Dolce and Gabbana The Primer Sheer Radiance Make Up Base with Sunscreen Broad Spectrum SPF 30 Ensulizole, Octinoxate, and Zinc Oxide LOTION TOPICAL 20140424 20190323 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company ENSULIZOLE; OCTINOXATE; ZINC OXIDE 1; 7.49; 3.92 g/100mL; g/100mL; g/100mL N 20181231 37000-400_5dfba039-36fb-356b-e053-2a91aa0a5e0f 37000-400 HUMAN OTC DRUG Crest 3D White Luxe Diamond Strong Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130901 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.6 mg/g N 20181231 37000-401_6363a829-d528-07c8-e053-2991aa0a915e 37000-401 HUMAN OTC DRUG Crest Complete Multi-Benefit Whitening plus Baking Soda and Peroxide with Tartar Protection Sodium fluoride PASTE, DENTIFRICE DENTAL 20180123 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.6 mg/g N 20191231 37000-402_43787c63-dd1b-6f54-e054-00144ff88e88 37000-402 HUMAN OTC DRUG Pepto-Bismol Bismuth Subsalicylate KIT 20110912 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company N 20181231 37000-403_440957f9-139c-739b-e054-00144ff88e88 37000-403 HUMAN OTC DRUG Pepto-Bismol Bismuth Subsalicylate KIT 20120305 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company N 20181231 37000-404_3fed436c-2381-74e4-e054-00144ff88e88 37000-404 HUMAN OTC DRUG Vicks QlearQuil All Day And All Night 24 Hour Allergy Relief Loratadine TABLET ORAL 20140301 20180701 ANDA ANDA076301 The Procter & Gamble Manufacturing Company LORATADINE 10 mg/1 N 20181231 37000-406_3fedf7ce-d4eb-5441-e054-00144ff8d46c 37000-406 HUMAN OTC DRUG Vicks QlearQuil Nighttime Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20140301 20180901 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37000-407_3fee1a20-b18b-5fc0-e054-00144ff8d46c 37000-407 HUMAN OTC DRUG Vicks QlearQuil Daytime Sinus and Congestion Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140301 20190204 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 37000-408_3fee7e83-53af-74ed-e054-00144ff8d46c 37000-408 HUMAN OTC DRUG Vicks QlearQuil Nighttime Sinus and Congestion Acetaminophen, Doxylamine succinate, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20140301 20180302 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 37000-409_3a5cdb1a-483c-6446-e054-00144ff8d46c 37000-409 HUMAN OTC DRUG Vicks QlearQuil Daytime Sinus and Congestion and Nighttime Sinus and Congestion Acetaminophen, Phenylephrine Hydrochloride, and Doxylamine Succinate KIT 20140721 20180305 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20181231 37000-410_60126a4d-494e-f801-e053-2a91aa0a4443 37000-410 HUMAN OTC DRUG Vicks QlearQuil 12 Hour Decongestant Moisturizing Oxymetazoline Hydrochloride SPRAY NASAL 20140301 20190901 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company OXYMETAZOLINE HYDROCHLORIDE .512 mg/mL N 20181231 37000-411_639e6bd2-336e-8063-e053-2a91aa0afee4 37000-411 HUMAN OTC DRUG Crest 3D White Whitening plus Therapy Sodium Fluoride KIT 20180123 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company N 20191231 37000-412_432787b8-a7f1-58f6-e054-00144ff8d46c 37000-412 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Cold and Flu Multi-Symptom Relief/Cold and Flu Nighttime Relief Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, and Doxylamine Succinate KIT 20140321 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20181231 37000-413_432787b8-a7f1-58f6-e054-00144ff8d46c 37000-413 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Cold and Flu Multi-Symptom Relief/Cold and Flu Nighttime Relief Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Acetaminophen, Doxylamine Succinate, and Dextromethorphan Hydrobromide KIT 20140321 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20181231 37000-414_432787b8-a7f1-58f6-e054-00144ff8d46c 37000-414 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Cold and Flu Multi-Symptom Relief/Cold and Flu Nighttime Relief Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Acetaminophen, Doxylamine Succinate, and Dextromethorphan Hydrobromide KIT 20140321 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20181231 37000-415_647a0c35-ac04-061b-e053-2a91aa0af592 37000-415 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Severe Cold and Flu Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Doxylamine Succinate and Guaifenesin KIT 20140721 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20191231 37000-416_647a0c35-ac04-061b-e053-2a91aa0af592 37000-416 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Severe Cold and Flu Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Doxylamine Succinate and Guaifenesin KIT 20140721 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20191231 37000-417_647a0c35-ac04-061b-e053-2a91aa0af592 37000-417 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Severe Cold and Flu Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide, Doxylamine Succinate and Guaifenesin KIT 20140721 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20191231 37000-430_56cae985-6b21-6cd7-e054-00144ff88e88 37000-430 HUMAN OTC DRUG ZzzQuil Nighttime Sleep-Aid Diphenhydramine Hydrochloride SOLUTION ORAL 20150203 OTC MONOGRAPH FINAL part338 The Procter & Gamble Manufacturing Company DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 37000-431_56cc72ac-20ec-1bab-e054-00144ff8d46c 37000-431 HUMAN OTC DRUG ZzzQuil Alcohol Free Nighttime Sleep-Aid Diphenhydramine Hydrochloride SOLUTION ORAL 20150203 OTC MONOGRAPH FINAL part338 The Procter & Gamble Manufacturing Company DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 37000-432_432b8c49-6902-2801-e054-00144ff88e88 37000-432 HUMAN OTC DRUG Vicks Sinex 12 Hour Nasal Decongestant Ultra Fine Mist Moisturizing Oxymetazoline Hydrochloride SPRAY NASAL 20150427 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company OXYMETAZOLINE HYDROCHLORIDE .0005095 g/mL N 20181231 37000-433_432b71ba-0845-23e9-e054-00144ff8d46c 37000-433 HUMAN OTC DRUG Vicks Sinex 12 Hour Decongestant Ultra Fine Mist Oxymetazoline Hydrochloride SPRAY NASAL 20150427 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company OXYMETAZOLINE HYDROCHLORIDE .0005095 g/mL N 20181231 37000-434_432b62ee-59b7-12c3-e054-00144ff8d46c 37000-434 HUMAN OTC DRUG Vicks Sinex 12 Hour Decongestant Oxymetazoline Hydrochloride SPRAY NASAL 20150427 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company OXYMETAZOLINE HYDROCHLORIDE .0005095 g/mL N 20181231 37000-435_432b724b-5f8e-20a7-e054-00144ff8d46c 37000-435 HUMAN OTC DRUG Vicks Sinex Scent Free Oxymetazoline Hydrochloride SPRAY NASAL 20150131 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company OXYMETAZOLINE HYDROCHLORIDE .05 g/mL N 20181231 37000-447_4ea42149-cf64-5237-e054-00144ff8d46c 37000-447 HUMAN OTC DRUG Vicks Formula 44 Cough Dextromethorphan Hydrobromide LIQUID ORAL 20170711 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL N 20181231 37000-448_54b19980-c09d-289c-e054-00144ff8d46c 37000-448 HUMAN OTC DRUG Vicks Formula 44 Cough and Chest Congestion Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20170711 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 200; 10 mg/15mL; mg/15mL N 20181231 37000-449_4ea4acf8-1852-57c0-e054-00144ff88e88 37000-449 HUMAN OTC DRUG Vicks Formula 44 Cough and Head Congestion Dextromethorphan Hydrobromide LIQUID ORAL 20170711 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 10; 5 mg/15mL; mg/15mL N 20181231 37000-450_4ea517e7-155e-1749-e054-00144ff8d46c 37000-450 HUMAN OTC DRUG Vicks Formula 44 Nighttime Cough and Cold Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide LIQUID ORAL 20170711 OTC MONOGRAPH FINAL part341 Procter & Gamble Manufacturing Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 650; 4; 30 mg/15mL; mg/15mL; mg/15mL N 20181231 37000-451_5269a365-e0cc-31da-e054-00144ff88e88 37000-451 HUMAN OTC DRUG Crest Pro-Health Multi-Protection Refreshing Clean Mint Cetylpyridinium chloride RINSE ORAL 20110203 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company CETYLPYRIDINIUM CHLORIDE .014 g/20mL N 20181231 37000-452_603bb0ba-9e93-4d2a-e053-2991aa0ab229 37000-452 HUMAN OTC DRUG Crest Pro-Health Cetylpyridinium chloride RINSE ORAL 20110314 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company CETYLPYRIDINIUM CHLORIDE .014 g/mL N 20181231 37000-455_6478fea5-e7e5-7e66-e053-2991aa0ad9b0 37000-455 HUMAN OTC DRUG Prilosec OTC omeprazole magnesium TABLET, DELAYED RELEASE ORAL 20030714 NDA NDA021229 The Procter & Gamble Manufacturing Company OMEPRAZOLE MAGNESIUM 20.6 mg/1 N 20191231 37000-456_5422c453-58e5-687c-e054-00144ff88e88 37000-456 HUMAN OTC DRUG Crest 3DWhite Whitening Therapy Sensitivity Care Potassium Nitrate, Sodium Fluoride PASTE, DENTIFRICE DENTAL 20170712 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE; POTASSIUM NITRATE 1.4; 50 mg/g; mg/g N 20181231 37000-457_5423a39f-099c-154a-e054-00144ff88e88 37000-457 HUMAN OTC DRUG Crest 3D White Whitening Therapy Enamel Care Sodium Fluoride PASTE, DENTIFRICE DENTAL 20170712 OTC MONOGRAPH FINAL part355 Procter & Gamble Manfuacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-459_647913b8-2416-2774-e053-2991aa0a227c 37000-459 HUMAN OTC DRUG Prilosec OTC OMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE ORAL 20120815 NDA NDA021229 The Procter & Gamble Manufacturing Company OMEPRAZOLE MAGNESIUM 20 mg/1 N 20191231 37000-468_5487ab10-4743-06f8-e054-00144ff88e88 37000-468 HUMAN OTC DRUG Crest Pro-Health Sensitivive and Enamel Shield Stannous Fluoride GEL, DENTIFRICE DENTAL 20161102 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.4 mg/g N 20181231 37000-469_3d7e0b1b-3824-3db3-e054-00144ff88e88 37000-469 HUMAN OTC DRUG Crest Tartar Protection Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20031006 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-470_440a0340-d470-13b4-e054-00144ff88e88 37000-470 HUMAN OTC DRUG Crest Anti-Cavity Regular SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20080801 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-475_3fdc9b6f-7785-3148-e054-00144ff88e88 37000-475 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate LIQUID ORAL 20040630 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 37000-476_42b1f397-4d50-1c6e-e054-00144ff8d46c 37000-476 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate TABLET ORAL 20040630 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 37000-477_5aa9b22d-7043-8095-e053-2a91aa0afade 37000-477 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate TABLET ORAL 20040630 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 37000-478_63274378-fbe0-63b1-e053-2a91aa0ae1a7 37000-478 HUMAN OTC DRUG Pepto-Bismol ULTRA Bismuth subsalicylate TABLET ORAL 20180201 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 525 mg/1 N 20191231 37000-479_6287bc3e-8b06-45d3-e053-2991aa0aaa10 37000-479 HUMAN OTC DRUG Crest Pro-Health Intense Clean Mint Cetylpyridinium chloride RINSE ORAL 20180101 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company CETYLPYRIDINIUM CHLORIDE .05 g/mL N 20191231 37000-480_62991165-ec82-48a8-e053-2991aa0a54f3 37000-480 HUMAN OTC DRUG Crest Pro-Health Intense Fresh Mint Cetylpyridinium chloride RINSE ORAL 20180101 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company CETYLPYRIDINIUM CHLORIDE .05 g/mL N 20191231 37000-481_6403114f-8c3c-bc4b-e053-2991aa0a5b89 37000-481 HUMAN OTC DRUG Crest Gum Detoxify Stannous fluoride PASTE, DENTIFRICE DENTAL 20170801 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.4 mg/g N 20191231 37000-489_647be942-7e14-c9e8-e053-2991aa0a9dd4 37000-489 HUMAN OTC DRUG Crest Gum Detoxify plus Whitening Stannous Fluoride KIT 20180101 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company N 20191231 37000-490_440a00b1-794b-0cc4-e054-00144ff8d46c 37000-490 HUMAN OTC DRUG Childrens Pepto Calcium Carbonate TABLET, CHEWABLE ORAL 20050720 OTC MONOGRAPH FINAL part331 The Procter & Gamble Manufacturing Company CALCIUM CARBONATE 400 mg/1 N 20181231 37000-492_64038690-96f1-2329-e053-2991aa0ad304 37000-492 HUMAN OTC DRUG Crest Gum Detoxify Gentle Whitening Stannous fluoride PASTE, DENTIFRICE DENTAL 20180129 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.4 mg/g N 20191231 37000-493_6402bef4-e19c-0795-e053-2991aa0a3aa0 37000-493 HUMAN OTC DRUG Crest 3D White Advanced Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20180122 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.6 mg/g N 20191231 37000-494_5dfb22aa-aa40-1339-e053-2a91aa0ae505 37000-494 HUMAN OTC DRUG Crest Complete Multi Benefit Whitening plus Scope Minty Fresh Gel Sodium Fluoride PASTE, DENTIFRICE DENTAL 20170801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-495_5dfb9541-d764-29e1-e053-2991aa0a039f 37000-495 HUMAN OTC DRUG Crest Blue Bubble Gum Sodium Fluoride PASTE, DENTIFRICE DENTAL 20080801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-500_566a3315-d34b-0d51-e054-00144ff88e88 37000-500 HUMAN OTC DRUG ZzzQuil Nighttime Sleep-Aid DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20111208 OTC MONOGRAPH FINAL part338 The Procter & Gamble Manufacturing Company DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 37000-501_64791a5d-d395-f1a1-e053-2a91aa0ae02b 37000-501 HUMAN OTC DRUG ZzzQuil Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, GELATIN COATED ORAL 20111208 OTC MONOGRAPH FINAL part338 The Procter & Gamble Manufacturing Company DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/21 N 20191231 37000-503_64043b8c-8277-680b-e053-2991aa0afec8 37000-503 HUMAN OTC DRUG Crest Gum Detoxify Extra Fresh Stannous fluoride PASTE, DENTIFRICE DENTAL 20180129 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.4 mg/g N 20191231 37000-507_647a96f7-7606-6dbb-e053-2a91aa0a9883 37000-507 HUMAN OTC DRUG Vicks Sinex Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160729 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20191231 37000-508_647aae03-f55d-cf86-e053-2991aa0adaff 37000-508 HUMAN OTC DRUG Sinex Acetaminophen, Doxylamine succinate, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20160729 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20191231 37000-509_3a35e213-b24c-5231-e054-00144ff88e88 37000-509 HUMAN OTC DRUG Sinex Acetaminophen, Phenylephrine Hydrochloride, and Doxylamine Succinate KIT 20140721 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20181231 37000-509_3a35e213-b24f-5231-e054-00144ff88e88 37000-509 HUMAN OTC DRUG Sinex Acetaminophen, Phenylephrine Hydrochloride, and Doxylamine Succinate KIT 20160729 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20181231 37000-510_5ae2f1ba-9b2d-fef4-e053-2991aa0a23e5 37000-510 HUMAN OTC DRUG Vicks DayQuil Cough Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 20151101 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/15mL; mg/15mL N 20181231 37000-522_440a00b1-7963-0cc4-e054-00144ff8d46c 37000-522 HUMAN OTC DRUG Vicks VapoSteam camphor (synthetic) LIQUID RESPIRATORY (INHALATION) 19950228 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company CAMPHOR (SYNTHETIC) .062 g/mL N 20181231 37000-544_46eca718-8aa1-46b5-e054-00144ff8d46c 37000-544 HUMAN OTC DRUG Vicks VapoRub Camphor (synthetic), Eucalyptus oil, and Menthol OINTMENT TOPICAL 19930730 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL .048; .012; .026 g/g; g/g; g/g N 20181231 37000-545_4e003699-3dc5-7377-e054-00144ff88e88 37000-545 HUMAN OTC DRUG Vicks VapoRub Lavender Scent Camphor (synthetic), Eucalyptus oil, and Menthol OINTMENT TOPICAL 20170701 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL .048; .012; .026 g/g; g/g; g/g N 20181231 37000-546_52a4945b-7333-484c-e054-00144ff88e88 37000-546 HUMAN OTC DRUG Vicks VapoRub childrens Camphor (synthetic), Eucalyptus oil, and Menthol OINTMENT TOPICAL 20170711 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL .048; .012; .026 g/g; g/g; g/g N 20181231 37000-550_501fc3f5-91be-4a6d-ae77-5b542d869078 37000-550 HUMAN OTC DRUG Vicks NyQuil Cough Dextromethorphan Hydrobromide and Doxylamine succinate LIQUID ORAL 20110622 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 37000-555_89c7d25a-02dd-4f6e-85e1-63cbdcd7722c 37000-555 HUMAN OTC DRUG Vicks DayQuil Cold and Flu Multi-Symptom Relief Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride LIQUID ORAL 20110622 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 37000-556_899b7907-7a0b-41da-b45b-1ce2f7773d2b 37000-556 HUMAN OTC DRUG Vicks Childrens NyQuil Cold and Cough Multi-Symptom Relief Chlorpheniramine maleate and Dextromethorphan Hydrobromide SOLUTION ORAL 20110622 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 2; 15 mg/15mL; mg/15mL N 20181231 37000-557_647a96f7-761e-6dbb-e053-2a91aa0a9883 37000-557 HUMAN OTC DRUG Vicks NyQuil Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20110609 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20191231 37000-558_647a96f7-7635-6dbb-e053-2a91aa0a9883 37000-558 HUMAN OTC DRUG Vicks DayQuil Cold and Flu Multi-Symptom Relief Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20110609 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 37000-565_3f518af5-8181-702d-e054-00144ff88e88 37000-565 HUMAN OTC DRUG Vicks DayQuil Cough Dextromethorphan Hydrobromide LIQUID ORAL 20110622 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL N 20181231 37000-574_3ebfd422-4f48-1eb0-e054-00144ff8d46c 37000-574 HUMAN OTC DRUG Crest Pro-Health Stannous Fluoride GEL, DENTIFRICE DENTAL 20060725 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20181231 37000-584_3d6ec358-3530-19d1-e054-00144ff88e88 37000-584 HUMAN OTC DRUG Crest Pro-Health Cetylpyridinium chloride RINSE ORAL 20070104 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company CETYLPYRIDINIUM CHLORIDE .014 g/mL N 20181231 37000-601_a9561dea-9ac2-439d-8866-76df76e93c6f 37000-601 HUMAN OTC DRUG Safeguard Antibacterial Foaming Benzalkonium Chloride SOAP TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company BENZALKONIUM CHLORIDE .12 g/100mL N 20181231 37000-602_387aeb02-b64e-447a-967a-3e56d4d08868 37000-602 HUMAN OTC DRUG Safeguard Antibacterial E2 Foaming Benzalkonium Chloride SOAP TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company BENZALKONIUM CHLORIDE .12 g/100mL N 20181231 37000-603_273266c6-4451-4c7b-9e3d-d99d3e2e8db3 37000-603 HUMAN OTC DRUG Safeguard Hand Sanitizer Alcohol GEL TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company ALCOHOL 64 g/100mL N 20181231 37000-604_6247c59d-2d5d-3d0b-e053-2a91aa0a4b0c 37000-604 HUMAN OTC DRUG Crest Pro-Health With a Touch of Scope Stannous fluoride PASTE, DENTIFRICE DENTAL 20170617 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.4 mg/g N 20191231 37000-616_603d483b-3336-434a-e053-2a91aa0a5369 37000-616 HUMAN OTC DRUG Dawn Ultra Antibacterial Hand Apple Blossom Scent Chloroxylenol SOAP TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part333E The Procter & Gamble Manufacturing Company CHLOROXYLENOL .3 g/100mL N 20181231 37000-617_603ff500-74ad-f542-e053-2991aa0a0c01 37000-617 HUMAN OTC DRUG Dawn Ultra Antibacterial Hand Orange Scent Chloroxylenol SOAP TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part333E The Procter & Gamble Manufacturing Company CHLOROXYLENOL .3 g/100mL N 20181231 37000-653_440a5c3b-d99a-233c-e054-00144ff8d46c 37000-653 HUMAN OTC DRUG Pepto-Bismol Max Strength Bismuth subsalicylate LIQUID ORAL 20040630 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 37000-671_441d884f-a7cb-3d99-e054-00144ff8d46c 37000-671 HUMAN OTC DRUG Vicks VapoRub Camphor (synthetic), Eucalyptus oil, and Menthol OINTMENT TOPICAL 19930730 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL .047; .012; .026 g/g; g/g; g/g N 20181231 37000-673_080debcd-5799-46cd-888f-d62f01917e99 37000-673 HUMAN OTC DRUG Crest Pro-Health Stages Sodium Fluoride PASTE, DENTIFRICE DENTAL 20080801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g N 20181231 37000-674_48e3c528-cb04-44a9-83e4-33e8d7404509 37000-674 HUMAN OTC DRUG Crest Pro-Health Stages Sodium Fluoride PASTE, DENTIFRICE DENTAL 20080801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g N 20181231 37000-675_fc5c8456-ce05-4b44-94d0-bc5917ddaa12 37000-675 HUMAN OTC DRUG Crest Pro-Health Stages Sodium Fluoride PASTE, DENTIFRICE DENTAL 20080801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.43 mg/g N 20181231 37000-679_441d79e7-7715-22ff-e054-00144ff88e88 37000-679 HUMAN OTC DRUG Vicks VapoDrops Cough Relief Menthol LOZENGE ORAL 20090430 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company MENTHOL 1.7 mg/1 N 20181231 37000-680_441db087-290c-415e-e054-00144ff8d46c 37000-680 HUMAN OTC DRUG Vicks VapoDrops Cough Relief Menthol LOZENGE ORAL 20090430 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company MENTHOL 3.3 mg/1 N 20181231 37000-691_71e02852-31c4-4cc6-8e70-c4ceb55f3225 37000-691 HUMAN OTC DRUG Pepto-Bismol InstaCool Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20090709 OTC MONOGRAPH FINAL part335 The Procter & Gamble Manufacturing Company BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 37000-693_40cfd13a-5730-1838-e054-00144ff88e88 37000-693 HUMAN OTC DRUG Crest Extra White plus Scope Outlast Long Lasting Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20090908 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-699_3f505f4c-d92f-3819-e054-00144ff88e88 37000-699 HUMAN OTC DRUG Vicks Alcohol Free NyQuil Cold and Flu Nighttime Relief Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide LIQUID ORAL 20100601 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 325; 2; 15 mg/15mL; mg/15mL; mg/15mL N 20181231 37000-714_3d0ad06c-6c3c-31c4-e054-00144ff88e88 37000-714 HUMAN OTC DRUG Safeguard Antibacterial Bar Beige Triclocarban SOAP TOPICAL 19630501 20180831 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company TRICLOCARBAN 1.356 g/113g N 20181231 37000-715_3d091a8a-d2ea-70d3-e054-00144ff88e88 37000-715 HUMAN OTC DRUG Safeguard Antibacterial White with Aloe TRICLOCARBAN SOAP TOPICAL 19990201 20180831 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company TRICLOCARBAN 1.356 g/113g N 20181231 37000-732_4adf4a34-d146-397a-e054-00144ff8d46c 37000-732 HUMAN OTC DRUG Nioxin Scalp Recovery Moisturizing Condtioner Pyrithione Zinc LIQUID TOPICAL 20131201 20180701 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 10 mg/mL N 20181231 37000-733_4adee0ac-c60a-23af-e054-00144ff8d46c 37000-733 HUMAN OTC DRUG Nioxin Scalp Recovery Soothing Serum Pyrithione Zinc LIQUID TOPICAL 20110101 20180701 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .97 mg/mL N 20181231 37000-739_4aee6720-59c8-3f4a-e054-00144ff88e88 37000-739 HUMAN OTC DRUG Nioxin Scalp Recovery Medicating Cleanser Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20110101 20180701 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 mg/mL N 20181231 37000-747_540fe789-dd67-37ca-e054-00144ff88e88 37000-747 HUMAN OTC DRUG Old Spice Fresher Collection Denali aluminum zirconium trichlorohydrex gly STICK TOPICAL 20100701 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .18 g/g N 20181231 37000-749_60a4777c-b1a8-2fcd-e053-2991aa0a8bb2 37000-749 HUMAN OTC DRUG Old Spice Fresher Collection Fiji Invisible aluminum zirconium trichlorohydrex gly STICK TOPICAL 20100701 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 37000-751_44a89313-dc8d-570a-e054-00144ff8d46c 37000-751 HUMAN OTC DRUG Secret Scent Expressions Invisible Solid Va Va Vanilla Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20081201 20181009 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .19 g/g N 20181231 37000-752_5b1e83c8-e39f-8793-e053-2991aa0ac79e 37000-752 HUMAN OTC DRUG Olay Complete All Day Moisturizer Broad Spectrum SPF 15 Combination/Oily Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120501 20190724 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 3; 5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 37000-754_44a9ceae-5c5c-3302-e054-00144ff8d46c 37000-754 HUMAN OTC DRUG Secret Scent Expressions Coco Butter Kiss Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20100405 20181006 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 37000-757_934684e1-5c18-4191-bf88-952d45450f83 37000-757 HUMAN OTC DRUG Covergirl Smoothers Tinted Moisturizer BB Broad Spectrum SPF 21 (all shades) Octinoxate and Zinc Oxide LIQUID TOPICAL 20130901 20180601 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 37000-761_44a9e136-a7f8-36b0-e054-00144ff8d46c 37000-761 HUMAN OTC DRUG Secret Scent Expressions So Very Summerberry Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20100405 20180927 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 37000-769_42a417d7-f8c2-5e17-e054-00144ff8d46c 37000-769 HUMAN OTC DRUG Gillette Sport Undefeated Invisible Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20141220 20180307 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 37000-771_425e1218-ffc7-2719-e054-00144ff8d46c 37000-771 HUMAN OTC DRUG Gillette Mach 3 Invisible Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130130 20180515 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .17 g/g N 20181231 37000-796_f867bf9b-205c-4885-b56f-0c764856f8c5 37000-796 HUMAN OTC DRUG Gucci Face Lustrous Glow Foundation Broadspectrum SPF 25 (all shades) Octinoxate and Titanium Dioxide LOTION TOPICAL 20140526 20180601 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 3.49; 2.52 g/100mL; g/100mL N 20181231 37000-798_4adf4a34-d12f-397a-e054-00144ff8d46c 37000-798 HUMAN OTC DRUG Pantene Pro-V Expert Collection Hair Regrowth Treatment for Women Minoxidil LIQUID TOPICAL 20131115 20180718 ANDA ANDA075357 The Procter & Gamble Manufacturing Company MINOXIDIL 2 g/100mL N 20181231 37000-801_601217a7-b265-98dc-e053-2a91aa0ad5c2 37000-801 HUMAN OTC DRUG Vicks Sinex 12 Hour Decongestant Ultra Fine Mist Moisturizing Oxymetazoline Hydrochloride SPRAY NASAL 20100706 20181015 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company OXYMETAZOLINE HYDROCHLORIDE .000512 g/mL N 20181231 37000-802_6011e637-57de-1e67-e053-2991aa0a3374 37000-802 HUMAN OTC DRUG Vicks Sinex 12 Hour Decongestant Ultra Fine Mist Oxymetazoline Hydrochloride SPRAY NASAL 20100706 20181210 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company OXYMETAZOLINE HYDROCHLORIDE .0005095 g/mL N 20181231 37000-807_43787b51-e6b6-6b40-e054-00144ff88e88 37000-807 HUMAN OTC DRUG Vicks NyQuil Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate SOLUTION ORAL 20100601 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 37000-808_437854c0-8c9c-6ef0-e054-00144ff8d46c 37000-808 HUMAN OTC DRUG Vicks NyQuil Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate LIQUID ORAL 20100601 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 37000-809_3f52018c-47f6-0d6a-e054-00144ff88e88 37000-809 HUMAN OTC DRUG Vicks NyQuil Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate LIQUID ORAL 20100601 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 37000-810_4409d593-8858-06e0-e054-00144ff8d46c 37000-810 HUMAN OTC DRUG Vicks DayQuil Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride SOLUTION ORAL 20130722 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 37000-811_647abbc5-f911-aae1-e053-2a91aa0a86df 37000-811 HUMAN OTC DRUG Vicks DayQuil Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20130722 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20191231 37000-812_43162f50-b0af-338c-e054-00144ff88e88 37000-812 HUMAN OTC DRUG Vicks NyQuil Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride SOLUTION ORAL 20130722 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 37000-813_647abbc5-f927-aae1-e053-2a91aa0a86df 37000-813 HUMAN OTC DRUG Vicks NyQuil Severe Cold and Flu Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, and Dextromethorphan Hydrobromide TABLET, COATED ORAL 20140721 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE 325; 5; 6.25; 10 mg/1; mg/1; mg/1; mg/1 N 20191231 37000-814_4315a1ab-3646-4369-e054-00144ff8d46c 37000-814 HUMAN OTC DRUG Vicks DayQuil and Vicks NyQuil Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, and doxylamine succinate KIT 20130722 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company N 20181231 37000-815_43174c92-4a2e-2546-e054-00144ff8d46c 37000-815 HUMAN OTC DRUG Vicks NyQuil Severe Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride SOLUTION ORAL 20140721 OTC MONOGRAPH FINAL part341 The Procter & Gamble Manufacturing Company PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN 10; 12.5; 20; 650 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 37000-819_527cd094-091b-1ed3-e054-00144ff8d46c 37000-819 HUMAN OTC DRUG Crest Complete Multi-Benefit Whitening plus Deep Clean Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-822_5dfb9541-d770-29e1-e053-2991aa0a039f 37000-822 HUMAN OTC DRUG Crest Complete Multi-Benefit Plus Scope Sodium Fluoride GEL, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g N 20181231 37000-823_5dfb9541-d77f-29e1-e053-2991aa0a039f 37000-823 HUMAN OTC DRUG Crest Complete Multi-Benefit Tartar Control Whitening Plus Scope Sodium Fluoride GEL, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g N 20181231 37000-825_5dfb22aa-aa4c-1339-e053-2a91aa0ae505 37000-825 HUMAN OTC DRUG Crest Complete Multi-Benefit Whitening Plus Herbal Mint Expressions SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g N 20181231 37000-826_5dfba039-36a9-356b-e053-2a91aa0a5e0f 37000-826 HUMAN OTC DRUG Crest Complete Multi-Benefit Whitening Plus Cinnamon Expressions Sodium Fluoride GEL, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g N 20181231 37000-828_5dfba039-36c1-356b-e053-2a91aa0a5e0f 37000-828 HUMAN OTC DRUG Crest Complete Multi-benefit Tartar Control Whitening Plus Scope Sodium Fluoride GEL, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.1 mg/g N 20181231 37000-829_40cf880f-56e3-47c0-e054-00144ff8d46c 37000-829 HUMAN OTC DRUG Crest Complete Multi-Benefit Extra Whitening with Tartar Protection Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.6 mg/g N 20181231 37000-830_40d073b7-05e3-0674-e054-00144ff8d46c 37000-830 HUMAN OTC DRUG Crest Complete Multi-Benefit Extra White plus Scope dual blast fresh mint blast Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110801 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-836_40cbe119-0320-0e8b-e054-00144ff8d46c 37000-836 HUMAN OTC DRUG Crest Pro-Health For Life Cetylpyridinium chloride RINSE ORAL 20120806 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company CETYLPYRIDINIUM CHLORIDE .014 g/20mL N 20181231 37000-839_3f27df7d-921a-44d8-e054-00144ff88e88 37000-839 HUMAN OTC DRUG Kids Crest Bubblegum Flavor Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110401 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-843_40cb8939-4517-0799-e054-00144ff88e88 37000-843 HUMAN OTC DRUG Crest Pro-Health Clinical Cetylpyridinium chloride RINSE ORAL 20110220 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company CETYLPYRIDINIUM CHLORIDE .02 g/20mL N 20181231 37000-848_40cbe119-032f-0e8b-e054-00144ff8d46c 37000-848 HUMAN OTC DRUG Crest Pro-Health Anticavity Fluoride Rinse Sodium Fluoride RINSE ORAL 20130708 20180501 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.2 mg/10mL N 20181231 37000-849_626e2e8d-2b0c-6fc8-e053-2991aa0a7fa9 37000-849 HUMAN OTC DRUG Crest Sensi-Relief Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20140108 20191206 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.4 mg/g; mg/g N 20191231 37000-852_527d8f8d-1c69-4372-e054-00144ff8d46c 37000-852 HUMAN OTC DRUG Crest 3D White Sodium Fluoride PASTE, DENTIFRICE DENTAL 20140204 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-853_40e011fe-0bbd-27ea-e054-00144ff8d46c 37000-853 HUMAN OTC DRUG Crest 3D White Sodium Fluoride PASTE, DENTIFRICE DENTAL 20140204 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-854_4403fe83-f1fa-14a7-e054-00144ff8d46c 37000-854 HUMAN OTC DRUG Crest Anticavity Fluoride Sodium Fluoride RINSE ORAL 20140417 20181201 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.2 mg/10mL N 20181231 37000-855_40e21583-adc0-28d8-e054-00144ff8d46c 37000-855 HUMAN OTC DRUG Crest 3D White Sodium Fluoride PASTE, DENTIFRICE DENTAL 20140701 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.6 mg/g N 20181231 37000-856_47553c67-346f-6097-e054-00144ff8d46c 37000-856 HUMAN OTC DRUG Crest Pro-Health HD Stannous Fluoride KIT 20140315 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company N 20181231 37000-858_4419f1ec-179d-3a01-e054-00144ff88e88 37000-858 HUMAN OTC DRUG Crest Sensi-Care Sodium Fluoride RINSE ORAL 20140721 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 2.2 mg/10mL N 20181231 37000-860_626e9654-6286-0ea0-e053-2991aa0a6a2e 37000-860 HUMAN OTC DRUG Crest Sensi-Repair and Prevent Stannous Fluoride PASTE, DENTIFRICE DENTAL 20140721 20191002 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20191231 37000-861_441acd88-a0f8-544b-e054-00144ff88e88 37000-861 HUMAN OTC DRUG Crest Pro-Health For Me Sodium Fluoride PASTE, DENTIFRICE DENTAL 20150115 20181201 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-862_4419c911-d33a-59e0-e054-00144ff8d46c 37000-862 HUMAN OTC DRUG Crest 3D White Luxe Diamond Strong Sodium Fluoride RINSE ORAL 20150219 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE .1 mg/mL N 20181231 37000-863_4533243f-7178-025e-e054-00144ff88e88 37000-863 HUMAN OTC DRUG Crest 3D White Brilliance Daily Cleansing and Whitening System Stannous Fluoride KIT 20150205 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company N 20181231 37000-865_4cfb6824-632e-1f9d-e054-00144ff8d46c 37000-865 HUMAN OTC DRUG Crest Pro-Health Advanced w/Extra Deep Clean Sodium Fluoride RINSE ORAL 20150720 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE .1 mg/mL N 20181231 37000-866_40cbe40f-ce62-16ba-e054-00144ff88e88 37000-866 HUMAN OTC DRUG Crest Pro-Health Advanced w/Extra Deep Clean Sodium Fluoride RINSE ORAL 20160729 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE .1 mg/mL N 20181231 37000-867_441a46f0-ecdd-4448-e054-00144ff88e88 37000-867 HUMAN OTC DRUG Crest Pro-Health Advanced w/Extra Whitening Sodium Fluoride RINSE ORAL 20150720 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE .1 mg/mL N 20181231 37000-868_1bb56fb7-a2d9-4418-91ea-4243510438bd 37000-868 HUMAN OTC DRUG Crest Fresh and White Sodium Fluoride PASTE, DENTIFRICE DENTAL 20150309 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-869_41fc6c25-995e-6e44-e054-00144ff88e88 37000-869 HUMAN OTC DRUG Crest Pro-Health Advanced with Extra Tartar Protection Sodium Fluoride RINSE ORAL 20150720 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE .1 mg/mL N 20181231 37000-871_544c50e1-4ef6-5f3a-e054-00144ff88e88 37000-871 HUMAN OTC DRUG Crest Pro-Health Advanced Stannous Fluoride PASTE, DENTIFRICE DENTAL 20150201 20190121 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20181231 37000-873_40e01c9c-3af2-418d-e054-00144ff8d46c 37000-873 HUMAN OTC DRUG Crest 3D White Brilliance Sodium Fluoride PASTE, DENTIFRICE DENTAL 20150706 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.6 mg/g N 20181231 37000-874_3f2758ba-ead3-2876-e054-00144ff88e88 37000-874 HUMAN OTC DRUG Crest Pro-Health Advanced Extra Whitening Power Plus Freshness Stannous Fluoride PASTE, DENTIFRICE DENTAL 20150916 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20181231 37000-875_62480617-408d-19df-e053-2991aa0a0d8a 37000-875 HUMAN OTC DRUG Crest 3D White Arctic Fresh Sodium Fluoride PASTE, DENTIFRICE DENTAL 20160118 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20191231 37000-876_643d727f-60db-0ddf-e053-2a91aa0ab330 37000-876 HUMAN OTC DRUG Crest 3D White Radiant Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20160118 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20191231 37000-877_40dff8e8-1002-573b-e054-00144ff88e88 37000-877 HUMAN OTC DRUG Crest Pro-Health Whitening Power GEL, DENTIFRICE DENTAL 20160620 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.4 mg/g N 20181231 37000-879_3e4c812d-476e-146b-e054-00144ff88e88 37000-879 HUMAN OTC DRUG Crest Pro-Health Intense Peppermint Stannous Fluoride GEL, DENTIFRICE DENTAL 20160101 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20181231 37000-880_42b38a22-849f-0053-e054-00144ff8d46c 37000-880 HUMAN OTC DRUG Crest Pro-Health Advanced Stannous Fluoride PASTE, DENTIFRICE DENTAL 20161229 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20181231 37000-881_42ae8678-648d-6ce7-e054-00144ff88e88 37000-881 HUMAN OTC DRUG Crest 3D White Sodium Fluoride PASTE, DENTIFRICE DENTAL 20161219 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-882_52a5aaa5-2f63-6949-e054-00144ff88e88 37000-882 HUMAN OTC DRUG Crest Pro-Health Stannous fluoride PASTE, DENTIFRICE DENTAL 20161219 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.4 mg/g N 20181231 37000-883_54d90668-522b-4330-e054-00144ff88e88 37000-883 HUMAN OTC DRUG Crest Minty Breeze Sodium Fluoride PASTE, DENTIFRICE DENTAL 20150115 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-884_52a59b8e-b118-501d-e054-00144ff88e88 37000-884 HUMAN OTC DRUG Crest Pro-Health Stannous fluoride PASTE, DENTIFRICE DENTAL 20161219 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.4 mg/g N 20181231 37000-885_544ca7e6-91fe-0189-e054-00144ff88e88 37000-885 HUMAN OTC DRUG Crest Pro-Health Extra Whitening Power Stannous Fluoride GEL, DENTIFRICE DENTAL 20160101 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20181231 37000-886_54d8a279-14fe-3508-e054-00144ff88e88 37000-886 HUMAN OTC DRUG Tween Crest Cavity Protection Sodium Fluoride PASTE, DENTIFRICE DENTAL 20170726 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.6 mg/g N 20181231 37000-887_3e83ac23-bd93-0031-e054-00144ff88e88 37000-887 HUMAN OTC DRUG Crest Pro-Health Advanced Extra Deep Clean Stannous Fluoride GEL, DENTIFRICE DENTAL 20160101 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20181231 37000-888_42ae186d-5d85-4bb2-e054-00144ff8d46c 37000-888 HUMAN OTC DRUG Crest Pro-Health Stannous fluoride PASTE, DENTIFRICE DENTAL 20161219 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.4 mg/g N 20181231 37000-889_544c80da-8f0d-1e87-e054-00144ff8d46c 37000-889 HUMAN OTC DRUG Crest Pro-Health Advanced Extra Gum Protection Stannous Fluoride GEL, DENTIFRICE DENTAL 20151001 20190124 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20181231 37000-890_626f07f0-34bb-5a58-e053-2a91aa0aa0ae 37000-890 HUMAN OTC DRUG Crest Pro-Health Advanced Stannous Fluoride PASTE, DENTIFRICE DENTAL 20161229 20191202 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20191231 37000-891_42b3fa81-ac90-14ab-e054-00144ff8d46c 37000-891 HUMAN OTC DRUG Crest Pro-Health Advanced Stannous Fluoride PASTE, DENTIFRICE DENTAL 20161229 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20181231 37000-892_544c0a1b-1770-6414-e054-00144ff88e88 37000-892 HUMAN OTC DRUG Crest Pro-Health Advanced Stannous Fluoride PASTE, DENTIFRICE DENTAL 20161229 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20181231 37000-893_62489a68-79e2-1d96-e053-2a91aa0a0112 37000-893 HUMAN OTC DRUG Vicks VapoCOOL Menthol LOZENGE ORAL 20171229 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company MENTHOL 15 mg/1 N 20191231 37000-894_6249b85f-74cd-a1c6-e053-2a91aa0ab7db 37000-894 HUMAN OTC DRUG Vicks VapoCOOL Severe Menthol LOZENGE ORAL 20171229 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company MENTHOL 20 mg/1 N 20191231 37000-896_60a2e223-9f49-2f3f-e053-2991aa0abf1c 37000-896 HUMAN OTC DRUG Kids Crest Strawberry Rush Sodium Fluoride RINSE ORAL 20171215 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE .1 mg/mL N 20181231 37000-897_60de787a-ff67-baaa-e053-2a91aa0a9c38 37000-897 HUMAN OTC DRUG Crest Complete Multi-Benefit Extra Whitening plus Scope Advanced Freshness Sodium fluoride PASTE, DENTIFRICE DENTAL 20171226 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company SODIUM FLUORIDE 1.5 mg/g N 20181231 37000-898_626ded57-e43b-f2e8-e053-2a91aa0abd7b 37000-898 HUMAN OTC DRUG Crest Sensitivity Whitening plus Scope Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20180101 OTC MONOGRAPH NOT FINAL part356 The Procter & Gamble Manufacturing Company POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.4 mg/g; mg/g N 20191231 37000-899_626e510c-a610-7553-e053-2a91aa0afa76 37000-899 HUMAN OTC DRUG Crest Sensitvity Complete Protection Stannous Fluoride PASTE, DENTIFRICE DENTAL 20180116 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20191231 37000-914_6492253c-6dbc-43d6-e053-2991aa0a3ebe 37000-914 HUMAN OTC DRUG Dolce and Gabbana The Lift Foundation Warm Rose 130 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140405 OTC MONOGRAPH NOT FINAL part352 Proter & Gamble Manufacturing Company OCTINOXATE; TITANIUM DIOXIDE 29.9; 25.2 mg/mL; mg/mL N 20191231 37000-915_626f4e66-a9ac-3769-e053-2a91aa0a7116 37000-915 HUMAN OTC DRUG Crest Pro-Health Advanced Sensitive and Enamel Shield Stannous Fluoride PASTE, DENTIFRICE DENTAL 20180116 OTC MONOGRAPH FINAL part355 The Procter & Gamble Manufacturing Company STANNOUS FLUORIDE 1.6 mg/g N 20191231 37012-002_b979411d-4f44-4eed-9b3a-d973955befa6 37012-002 HUMAN OTC DRUG Shopko Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Shopko Stores Operating Co., LLC CLOTRIMAZOLE 10 mg/g N 20181231 37012-003_74c31238-d1ab-4a8a-b8b7-dc8e845145b0 37012-003 HUMAN OTC DRUG daytime nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20150902 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC N 20181231 37012-004_6580f914-04ac-4028-a18d-c81dfaa84d15 37012-004 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20110615 OTC MONOGRAPH FINAL part355 Shopko Stores Operating Co.LLC SODIUM FLUORIDE 10.4 mg/mL N 20191231 37012-007_97ccdb97-e09d-4a4a-a131-7a36f218a8b7 37012-007 HUMAN OTC DRUG Nasoflow Fluticasone propionate SPRAY, METERED NASAL 20160601 ANDA ANDA207957 Shopko Stores Operating Co., LLC FLUTICASONE PROPIONATE 50 ug/1 N 20181231 37012-009_eb0ec0db-334b-43c2-82e1-5c5c16bfecac 37012-009 HUMAN OTC DRUG Acid Reducer Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20160112 ANDA ANDA077355 Shopko Stores Operating Co., LLC FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 37012-012_86195e57-16ae-424d-b021-495edee4ab61 37012-012 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20170308 ANDA ANDA206394 Shopko Stores Operating Co., LLC NICOTINE 2 mg/1 N 20181231 37012-013_a290d25a-d6fb-4e95-848a-c42b2b4992fd 37012-013 HUMAN OTC DRUG Allergy Relief D Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20131002 ANDA ANDA076050 Shopko Stores Operating Co., LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 37012-016_ad4fde13-4274-4a78-ab72-8a16543f5688 37012-016 HUMAN OTC DRUG Shopko Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Shopko Stores Operating Co., LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 37012-018_de30ed6d-e1ee-4c75-8a68-0ad992991039 37012-018 HUMAN OTC DRUG Shopko Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Shopko Stores Operating Co., LLC HYDROCORTISONE 1 g/100g N 20181231 37012-026_8a864edf-5741-44a4-8615-e809ce986588 37012-026 HUMAN OTC DRUG Shopko Long Lasting Oil Free Moisturizer Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Shopko Stores Operating Co., LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 4; 3 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 37012-027_5abc93cf-759d-4df7-81f2-b550f57464ee 37012-027 HUMAN OTC DRUG Shopko Triple Antibiotic plus Pain Relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Shopko Stores Operating Co., LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 37012-035_ca12b4f1-e74f-4feb-b099-302b2c66d2f5 37012-035 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 19970113 ANDA ANDA074444 Shopko Stores Operating Co., LLC MICONAZOLE NITRATE 2 mg/100g N 20181231 37012-036_1ab4ceb0-cbc8-414a-a843-e81625122e0c 37012-036 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100723 ANDA ANDA090283 Shopko Stores Operating Co., LLC FAMOTIDINE 20 mg/1 N 20181231 37012-040_4a25d331-e809-39f0-e054-00144ff88e88 37012-040 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20130814 OTC MONOGRAPH FINAL part341 ShopKo Stores Operating Co. LLC MENTHOL 5.4 mg/1 N 20181231 37012-041_4a38414c-4bff-37ab-e054-00144ff88e88 37012-041 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20130814 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co. LLC MENTHOL 5.4 mg/1 N 20181231 37012-042_4a3925c7-e9fd-5deb-e054-00144ff8d46c 37012-042 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20130814 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co. LLC MENTHOL 5.8 mg/1 N 20181231 37012-043_4a3951ed-3deb-6eec-e054-00144ff8d46c 37012-043 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20130814 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co. LLC MENTHOL 5.8 mg/1 N 20181231 37012-044_4a3b912a-501c-7080-e054-00144ff8d46c 37012-044 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20130814 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co. LLC MENTHOL 7.5 mg/1 N 20181231 37012-045_4a3c9565-5bae-27f4-e054-00144ff8d46c 37012-045 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20130814 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co. LLC MENTHOL 7.5 mg/1 N 20181231 37012-050_8f30ecad-780b-4e83-aa55-001774833f2a 37012-050 HUMAN OTC DRUG Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, FILM COATED ORAL 20160803 ANDA ANDA079113 Shopko Stores Operating Co., LLC DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20191231 37012-052_fd1d0887-94a6-4850-ab28-efdc3afc8f95 37012-052 HUMAN OTC DRUG SleepTime Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20160727 OTC MONOGRAPH FINAL part338 Shopko Stores Operating Co., LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37012-054_920f6338-8f00-40e1-af47-8bdea5fa5540 37012-054 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140310 ANDA ANDA075153 Shopko Stores Operating Co., LLC PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 37012-056_9de7d2cb-8888-4385-85e9-84b86fd63a45 37012-056 HUMAN OTC DRUG night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140602 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 37012-059_1471ced7-154c-4d12-894c-a26fc84ce313 37012-059 HUMAN OTC DRUG Shopko Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Shopko Stores Operating Co., LLC HYDROCORTISONE 1 g/100g N 20181231 37012-063_044f1876-e8a0-4a8a-92fb-200d64fb4abf 37012-063 HUMAN OTC DRUG Shopko Hydrocortisone Plus 12 Moisturizers Maximum Strength Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Shopko Stores Operating Co., LLC HYDROCORTISONE 1 g/100g N 20181231 37012-065_e4caa92d-e2bf-47f4-be02-06813a80010f 37012-065 HUMAN OTC DRUG Nasal Oxymetazoline HCl SPRAY NASAL 20130819 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 37012-069_d489c8e6-9c18-4214-bfe3-3c08aa617d91 37012-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19901215 OTC MONOGRAPH FINAL part347 Shopko PETROLATUM 1 g/g N 20181231 37012-070_061b13c2-5bbc-4d35-a13b-c96fc460113f 37012-070 HUMAN OTC DRUG Miconazole 3 Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Shopko Stores Operating Co., LLC MICONAZOLE NITRATE 40 mg/g N 20181231 37012-072_f5078528-67fe-4e6f-875b-8710fde63009 37012-072 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 20080108 OTC MONOGRAPH NOT FINAL part348 Shopko EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37012-074_c20cc954-1490-4575-96cf-1720509bd589 37012-074 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130819 ANDA ANDA077349 Shopko Stores Operating Co., LLC IBUPROFEN 200 mg/1 N 20181231 37012-075_bb9d981c-00df-46ec-973b-4dd17a54068a 37012-075 HUMAN OTC DRUG Shopko Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Shopko Stores Operating Co., LLC BACITRACIN ZINC 500 [iU]/g N 20181231 37012-076_16730c70-ef40-49bb-b5ac-86fb703bbe65 37012-076 HUMAN OTC DRUG Shopko Chest Congestion Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Shopko GUAIFENESIN 400 mg/1 N 20181231 37012-077_096b79d6-3275-42b2-99ba-fed836ade8dc 37012-077 HUMAN OTC DRUG Skopko Chest Congestion Relief PE PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Shopko GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 37012-078_18efbd68-d3c4-4058-a305-56dfbb79dd2c 37012-078 HUMAN OTC DRUG Shopko Chest Congestion Relief DMTDM TDM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Shopko DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 37012-080_a6b8ac61-c68f-4fc2-b8be-e1d779211017 37012-080 HUMAN OTC DRUG Shopko Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Shopko Stores Operating Co., LLC TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 37012-089_c7be4695-4097-473e-a126-0d8e3516e9cc 37012-089 HUMAN OTC DRUG Shopko Anti-Itch diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH NOT FINAL part348 Shopko Stores Operating Co., LLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 37012-094_3dd819bf-179f-42af-bc85-87668a063417 37012-094 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20131002 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 37012-098_042fa206-9a4f-4ee4-a8e4-14fd362c8c99 37012-098 HUMAN OTC DRUG Skopko Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER Skopko PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 37012-099_7e1eaf0b-d2d4-4d4a-9cb1-ad1a97954b1a 37012-099 HUMAN OTC DRUG Shopko Hydrocortisone Intensive Healing Formula Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Shopko Stores Operating Co., LLC HYDROCORTISONE 1 g/100g N 20181231 37012-100_4f354db5-4692-441e-b1d0-196e77e5e52e 37012-100 HUMAN OTC DRUG SHOPKO Antibacterial Hands and Face Fresh Scent BENZALKONIUM CHLORIDE CLOTH TOPICAL 20121105 OTC MONOGRAPH NOT FINAL part333A Shopko Stores Operating Co., LLC. BENZALKONIUM CHLORIDE .13 g/1 N 20181231 37012-103_c14e870e-e5a5-405e-b97c-b835ee50375c 37012-103 HUMAN OTC DRUG Acid Reducer Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160106 ANDA ANDA077355 Shopko Stores Operating Co., LLC FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 37012-110_28787271-ff85-4a97-b90c-e3d27895b594 37012-110 HUMAN OTC DRUG stool softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC. DOCUSATE SODIUM 100 mg/1 N 20181231 37012-117_8f6b950c-80ff-4f60-9a93-833d9170fdc0 37012-117 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130605 ANDA ANDA202319 Shopko Stores Operating Co., LLC LANSOPRAZOLE 15 mg/1 N 20181231 37012-120_e9c03d25-155e-402a-8023-fd0a573e3c8f 37012-120 HUMAN OTC DRUG womans laxative Bisacodyl TABLET, COATED ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC. BISACODYL 5 mg/1 N 20181231 37012-121_75c97544-0b3e-411b-a9d3-b87a646a6384 37012-121 HUMAN OTC DRUG SHOPKO Maximum Strength Medicated with Aloe and Witch Hazel WITCH HAZEL CLOTH TOPICAL 20130716 OTC MONOGRAPH FINAL part346 Shopko Stores Operating Co., LLC. WITCH HAZEL 50 g/100g N 20181231 37012-123_afec31fa-c850-499e-9f87-475eec5ce0d4 37012-123 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Shopko Stores Operating Co., LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 37012-127_234f3e92-c5c5-4f28-b29e-619854e2b44b 37012-127 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20100711 ANDA ANDA078653 Shopko Stores Operating Co., LLC. RANITIDINE HYDROCHLORIDE 150 mg/1 E 20171231 37012-130_3a6d0068-15b7-4f00-935a-72aaf414dabc 37012-130 HUMAN OTC DRUG childrens pain relief Acetaminophen SUSPENSION ORAL 20160803 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN 160 mg/5mL N 20181231 37012-161_2e366464-8dbe-4402-9d7b-397b6ddbc911 37012-161 HUMAN OTC DRUG Pain Relief Acetaminophen SUSPENSION ORAL 20140813 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN 160 mg/5mL N 20181231 37012-163_0be26ea0-a06c-4f5f-84c6-3c91d57d5d7c 37012-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20060513 OTC MONOGRAPH FINAL part355 ShopKo Stores Operating Co., LLC SODIUM FLUORIDE .1 mg/mL N 20181231 37012-166_fd356398-4fc8-4b1b-830c-7afce38d0e10 37012-166 HUMAN OTC DRUG childrens ibuprofen Ibuprofen SUSPENSION ORAL 20160803 ANDA ANDA074937 Shopko Stores Operating Co., LLC IBUPROFEN 100 mg/5mL N 20181231 37012-170_c10b26b3-2999-450a-8853-406c5551b107 37012-170 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20150528 ANDA ANDA076789 Shopko Stores Operating Co., LLC NICOTINE 4 mg/1 N 20181231 37012-174_b214e838-cde2-47b5-9273-7ba2e8dc792b 37012-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141231 NDA NDA021920 Shopko Stores Operating Co., LLC. NAPROXEN SODIUM 220 mg/1 N 20181231 37012-175_a45585b7-9dd7-4eaa-974a-2721065946d6 37012-175 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen SUSPENSION ORAL 20131031 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN 160 mg/5mL N 20181231 37012-176_8b621732-90f2-489e-ad5c-7af655fddfc8 37012-176 HUMAN OTC DRUG Allergy Relief D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20130907 ANDA ANDA077170 Shopko Stores Operating Co., LLC CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 37012-186_bebdbc84-b43e-41c9-a807-d1098b64e8c6 37012-186 HUMAN OTC DRUG Sleeptime Diphenhydramine HCl SOLUTION ORAL 20160727 OTC MONOGRAPH FINAL part338 Shopko Stores Operating Co., LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 37012-189_c15a09cc-bd0a-4b2c-b102-cdadcbfc2f03 37012-189 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET ORAL 20120611 ANDA ANDA079112 Shopko Stores Operating Co., LLC. FEXOFENADINE HYDROCHLORIDE 180 mg/1 E 20171231 37012-194_c073615a-805d-4ac9-8051-132c4fc6a123 37012-194 HUMAN OTC DRUG Acid Controller Famotidine TABLET ORAL 20130717 ANDA ANDA077351 Shopko Stores Operating Co., LLC FAMOTIDINE 20 mg/1 N 20181231 37012-199_5b630b51-cb5c-4f12-ad57-c54bd8d4b30f 37012-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100709 ANDA ANDA078682 Shopko Stores Operating Co., LLC. IBUPROFEN 200 mg/1 E 20171231 37012-204_de0f0d0a-d2aa-4580-bc53-3e26bfde12b5 37012-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Shopko Stores Operating Co., LLC PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 37012-211_ffe145a5-f0e7-4e58-a580-e16115a9de24 37012-211 HUMAN OTC DRUG SHOPKO Medicated Cooling WITCH HAZEL SWAB TOPICAL 20170509 OTC MONOGRAPH FINAL part346 Shopko Stores Operating Co., LLC. WITCH HAZEL 50 g/100g N 20181231 37012-213_cd961084-2fb6-4265-b9dd-ebd0e7a5865b 37012-213 HUMAN OTC DRUG Anticavity Sodium Fluoride RINSE ORAL 20110602 OTC MONOGRAPH FINAL part355 ShopKo Stores SODIUM FLUORIDE .05 mg/mL N 20181231 37012-224_9524b648-5c01-4313-bfa3-315041f924ce 37012-224 HUMAN OTC DRUG anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20030307 ANDA ANDA075232 Shopko Stores Operating Co., LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20191231 37012-227_99ed417b-6658-4a7d-aba7-64c44414c10d 37012-227 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20131211 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN 500 mg/1 N 20181231 37012-238_c7ea393a-495b-4a30-9aeb-de0ce5228df0 37012-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140315 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC. DOCUSATE SODIUM 100 mg/1 N 20181231 37012-239_d08913ea-396b-4ad1-8a1f-d0a62630e604 37012-239 HUMAN OTC DRUG Allergy Relief-D 24 Hour Loratadine and Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20160301 ANDA ANDA075706 Shopko Stores Operating Co., LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 37012-243_7785374e-8ef1-4b55-95d5-22ffe6a89186 37012-243 HUMAN OTC DRUG Handsoap Triclosan LIQUID TOPICAL 20090210 OTC MONOGRAPH NOT FINAL part333A ShopKo Stores Operating Co., LLC TRICLOSAN 1.545 mg/mL N 20181231 37012-255_68e457e6-599f-47f9-a5ab-5c24e9b1df11 37012-255 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20130730 ANDA ANDA075217 Shopko Stores Operating Co., LLC IBUPROFEN 50 mg/1.25mL N 20181231 37012-272_13ab3b2a-d7bf-4d0f-9507-df2f5bdc6e12 37012-272 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130909 ANDA ANDA072096 Shopko Stores Operating Co., LLC IBUPROFEN 200 mg/1 N 20181231 37012-279_44d74897-13cb-4a24-90bc-fd58a3399943 37012-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141029 OTC MONOGRAPH FINAL part346 Shopko Stores Operating Co., LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 37012-299_7b3c5bfe-15a5-41d1-923d-55b8fb1b2f17 37012-299 HUMAN OTC DRUG Antiseptic Cetylpyridinium chloride MOUTHWASH ORAL 20090813 OTC MONOGRAPH NOT FINAL part356 Shopko Stores Operating CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 37012-302_8bc09bcf-6f54-4274-87ca-25cad94ecbca 37012-302 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20131114 OTC MONOGRAPH FINAL part335 Shopko Stores Operating Co., LLC BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 37012-304_3f2162cb-3a22-4826-90fe-0efbead0ab13 37012-304 HUMAN OTC DRUG Nasal oxymetazoline hydrochloride SPRAY NASAL 20130711 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 37012-306_cc5527ab-f3e3-4cd9-9f31-1a9e861c4976 37012-306 HUMAN OTC DRUG clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20130605 ANDA ANDA090685 Shopko Stores Operating Co., LLC POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 37012-307_61fa1808-617e-488e-b001-6d0196814d85 37012-307 HUMAN OTC DRUG 24 hour allergy nasal Fluticasone propionate SPRAY, METERED NASAL 20160823 ANDA ANDA207957 Shopko Stores Operating Co., LLC FLUTICASONE PROPIONATE 50 ug/1 N 20181231 37012-309_8def5fcc-43ba-45a3-ace2-573ab047b2c7 37012-309 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170223 ANDA ANDA206393 Shopko Stores Operating Co., LLC NICOTINE 4 mg/1 N 20181231 37012-318_ab4746b3-535f-4685-b349-659688d98903 37012-318 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 19910109 OTC MONOGRAPH NOT FINAL part356 Shopko Operating Co., LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37012-325_20c3a16b-f4a2-4f74-9102-4ba9f3c02639 37012-325 HUMAN OTC DRUG Mucus ER Max Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160810 ANDA ANDA091009 Shopko Stores Operating Co., LLC GUAIFENESIN 1200 mg/1 N 20181231 37012-326_239d49ad-58d3-4c48-b6fc-38ef479e5521 37012-326 HUMAN OTC DRUG ShopKo Illuminating Daily Moisturizer Broad Spectrum SPF15 Sunscreen Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Shopko Stores Operating Co., LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mg/100mL; mg/100mL; mg/100mL N 20181231 37012-332_8f5f2a1d-272a-4825-aeaf-3662103864cd 37012-332 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20130624 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 37012-333_74d80c8c-fd10-4aac-9fbf-0821d434f28a 37012-333 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Shopko Stores Operating Co., LLC ACETAMINOPHEN 650 mg/1 N 20181231 37012-335_7df7dc9c-7969-4b7b-9a0f-13a1ac832a1e 37012-335 HUMAN OTC DRUG Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20130805 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 37012-337_801c2130-d6c6-42c5-9779-8e590fd55917 37012-337 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20130919 OTC MONOGRAPH FINAL part335 Shopko Stores Operating Co., LLC BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 37012-340_92dde609-b71e-4e41-89e0-375c374660cf 37012-340 HUMAN OTC DRUG antacid aluminum hydroxide, magnesium hydroxide, simethicone SUSPENSION ORAL 20130605 OTC MONOGRAPH FINAL part331 Shopko Stores Operating Co., LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 37012-351_5e4f79dd-4223-4bb2-9335-b195fc32eed6 37012-351 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20120330 ANDA ANDA200536 Shopko Stores Operating Co., LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 37012-357_2af46986-2196-4a51-9f4a-44fa1a18ec5e 37012-357 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20140519 OTC MONOGRAPH FINAL part331 Shopko Stores Operating Co., LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 37012-359_1201e252-1262-4aa0-adfb-007a0343734b 37012-359 HUMAN OTC DRUG Adults Tussin DM Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20130708 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 37012-368_b088dbc5-483c-45f9-9876-378d8843efff 37012-368 HUMAN OTC DRUG naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20140519 ANDA ANDA074661 Shopko Stores Operating Co., LLC NAPROXEN SODIUM 220 mg/1 N 20181231 37012-370_eac622a2-905a-44ef-a00f-23e42da4e7aa 37012-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part333A ShopKo Stores Operating Co., LLC ALCOHOL 70 mL/100mL N 20181231 37012-374_98b2f86f-ad2e-4fa7-ab6a-0fb0198fc13c 37012-374 HUMAN OTC DRUG Migraine Relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20020701 ANDA ANDA075794 Shopko Stores Operating Co., LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 37012-379_485ea1e5-a0a7-496e-82e3-1e3ab7b6966b 37012-379 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine HCl SOLUTION ORAL 20130912 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 37012-384_0c62155f-dc49-4b03-be8c-45de55f715cd 37012-384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130708 ANDA ANDA091135 Shopko Stores Operating Co., LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 37012-388_05c5571a-cb1b-4918-b08a-eec47ff74753 37012-388 HUMAN OTC DRUG nasal mist Oxymetazoline HCl SPRAY NASAL 20140924 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 37012-396_e4633619-4467-41f8-8fdb-8e1dd33989b5 37012-396 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20130605 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 37012-401_68a24c01-f3b7-4302-a71a-12dfe2d03d98 37012-401 HUMAN OTC DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20151202 NDA NDA022032 Shopko Stores Operating Co., LLC OMEPRAZOLE 20 mg/1 N 20181231 37012-407_18f673d3-d34e-46ec-adcd-dfe7f0e1ca6f 37012-407 HUMAN OTC DRUG ShopKo Cold Sore Treatment Camphor CREAM TOPICAL 20130416 OTC MONOGRAPH NOT FINAL part348 ShopKo Stores Operating Co., LLC BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 37012-408_fc0f51f4-730e-40b0-a051-391a847420ef 37012-408 HUMAN OTC DRUG Shopko Maximum Strength Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Shopko Stores Operating Co., LLC HYDROCORTISONE 1 g/100g N 20181231 37012-412_2ddfea2d-2804-4f69-a3fc-cf096a711974 37012-412 HUMAN OTC DRUG Antibacterial Body Wash Benzalkonium chloride LOTION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part333A Shopko Stores Operating Co.LLC BENZALKONIUM CHLORIDE 1.313 mg/mL N 20181231 37012-432_38c5fc08-a649-4d3a-ad70-99eec31c825f 37012-432 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130907 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 37012-435_44273e14-2249-4713-b2a6-bbc1eddbe6f0 37012-435 HUMAN OTC DRUG Anticavity Sodium Fluoride LIQUID ORAL 20150401 OTC MONOGRAPH FINAL part355 ShopKo SODIUM FLUORIDE .2 mg/mL N 20181231 37012-437_c7a35696-f552-4b47-b715-d00ee8387341 37012-437 HUMAN OTC DRUG pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20160406 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 37012-439_7c8222cc-fe49-4e0f-958b-e3723c03f797 37012-439 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohl LIQUID TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part333A Shopko Stores Operating Co., LLC ALCOHOL 616 mg/mL N 20181231 37012-458_c48f25b4-4eb8-430f-809f-f460d8ba9a7c 37012-458 HUMAN OTC DRUG Allergy Relief Cetirizine Hydrochloride TABLET ORAL 20130708 ANDA ANDA078336 Shopko Stores Operating Co., LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 37012-459_2f3e38e4-f94f-40dd-8930-5b265a19f323 37012-459 HUMAN OTC DRUG cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20130805 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 37012-461_16fb62aa-ebde-4b71-99cb-1b55b12f7510 37012-461 HUMAN OTC DRUG Junior Strength Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20130730 ANDA ANDA076359 Shopko Stores Operating Co., LLC IBUPROFEN 100 mg/1 N 20181231 37012-462_cea9db2d-d8d4-42d5-a87b-878bf662be94 37012-462 HUMAN OTC DRUG Allergy Relief diphenhydramine HCl CAPSULE ORAL 20161007 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37012-465_fa1ddce4-e9ae-4262-a761-97d8ff026bef 37012-465 HUMAN OTC DRUG Sunscreen Lip Balm Shopko Avobenzone 2.0% Octisalate 4.0% Octocrylene 10.0% Oxybenzone 6.0% STICK TOPICAL 20150315 OTC MONOGRAPH NOT FINAL part352 Shopko Stores Operating Co., LLC Corporate AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 4; 10; 6 g/100g; g/100g; g/100g; g/100g N 20181231 37012-469_66a50249-d975-462d-b309-4de6abadc79a 37012-469 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20140101 OTC MONOGRAPH FINAL part335 Shopko Stores Operating Co., LLC BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 37012-470_e4ee3571-abba-4769-bd98-87c116c2dd57 37012-470 HUMAN OTC DRUG Day Time Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20110325 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 37012-475_6c185cf9-4f30-467a-a5a2-e311f3a16e5a 37012-475 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine HCl SOLUTION ORAL 20160322 ANDA ANDA204226 Shopko Stores Operating Co., LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 37012-479_c165de24-b841-43ce-bdbf-c4326e983f2b 37012-479 HUMAN OTC DRUG Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20130909 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37012-480_ac01829e-66b0-4d32-914f-2be9f32b14f0 37012-480 HUMAN OTC DRUG Night time cold/flu relief multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120830 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 37012-482_08fbf2c2-45d6-4a76-a1f8-28113034e0a3 37012-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 19820715 OTC MONOGRAPH FINAL part355 ShopKo Stores Operating., LLC SODIUM FLUORIDE .1 mg/mL N 20181231 37012-484_ee48049d-9a51-413d-a573-64942721e60e 37012-484 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET ORAL 20130808 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN 500 mg/1 N 20181231 37012-486_361bd868-5450-4d88-99fd-490a1fd9c78e 37012-486 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20130613 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC DOCUSATE SODIUM 100 mg/1 N 20181231 37012-490_bb47e779-44e4-48b7-a392-fe3428a0eae1 37012-490 HUMAN OTC DRUG DayTime Nighttime multi symptom cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120510 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC. N 20181231 37012-499_a5c384e1-ae85-4749-99d5-f04649fdf795 37012-499 HUMAN OTC DRUG Shopko Alcohol Swabs Isopropyl Alcohol SWAB TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333A SHOPKO STORES OPERATING CO., LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 37012-506_d0a3d86c-f17d-431b-9177-ce5791f86056 37012-506 HUMAN OTC DRUG Shopko Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Shopko Stores Operating Co., LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 37012-516_5236f367-8845-44ce-86d2-d074d270b656 37012-516 HUMAN OTC DRUG Tussin CF Cough and Cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20130708 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 37012-521_6147d779-c32f-429a-86c5-84efcfc04ca7 37012-521 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20130806 ANDA ANDA076359 Shopko Stores Operating Co., LLC IBUPROFEN 100 mg/1 N 20181231 37012-523_9397de15-2a99-47f9-b0ca-99faf37fea80 37012-523 HUMAN OTC DRUG Shopko Healing Petrolatum OINTMENT TOPICAL 20140501 OTC MONOGRAPH FINAL part347 Shopko Stores Operating Co., LLC PETROLATUM 41 g/100g N 20181231 37012-526_21c4e5cc-a1e7-467c-ab88-a2cde5b56c68 37012-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Shopko Stores Operating Co., LLC LORATADINE 10 mg/1 N 20181231 37012-527_03adedd8-1cda-4e10-a2a2-5680a260809e 37012-527 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Shopko Stores Operating Co., LLC LORATADINE 10 mg/1 N 20181231 37012-544_85d9ed7c-63a3-4bf8-bf59-c11a3e84008f 37012-544 HUMAN OTC DRUG Arthritis Pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131002 ANDA ANDA075077 Shopko Stores Operating Co., LLC ACETAMINOPHEN 650 mg/1 N 20181231 37012-548_1e1ce3ec-0357-4915-a399-7973b3e936d9 37012-548 HUMAN OTC DRUG Day Time Severe acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20150902 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 37012-550_6328825e-75af-4446-8e0b-19dd3c7b504b 37012-550 HUMAN OTC DRUG Extra Strength Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20100602 OTC MONOGRAPH FINAL part332 Shopko Stores Operating Co., LLC. DIMETHICONE 125 mg/1 N 20181231 37012-571_730a6a8f-4180-48dc-8913-3d87752f8474 37012-571 HUMAN OTC DRUG Allergy Relief fexofenadine hcl TABLET, FILM COATED ORAL 20130708 ANDA ANDA076447 Shopko Stores Operating Co., LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 37012-580_83ab7484-6bd3-49d9-acb0-9a0540e81aac 37012-580 HUMAN OTC DRUG Daytime Nighttime Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140603 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC N 20181231 37012-588_59539acd-c748-46aa-8da1-717e72c39e83 37012-588 HUMAN OTC DRUG Antacid Aluminum Hydroxide, Magnesium Hydroxide, Simethicone SUSPENSION ORAL 20130605 OTC MONOGRAPH FINAL part332 Shopko Stores Operating Co., LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 37012-602_114a4755-ab62-490a-88f0-1d7678ae29bb 37012-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20090605 OTC MONOGRAPH NOT FINAL part334 ShopKo Stores Operating Co., LLC MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 37012-603_bc581a26-e6d6-408b-803e-8703b7c8e737 37012-603 HUMAN OTC DRUG Daytime Severe acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20150902 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 37012-604_d2e98cdd-e5f2-47ea-b538-cd8c1144b917 37012-604 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130909 ANDA ANDA072096 Shopko Stores Operating Co., LLC IBUPROFEN 200 mg/1 N 20181231 37012-612_c9009d67-617b-47b9-bf17-206136f809fc 37012-612 HUMAN OTC DRUG Allergy Relief Loratadine TABLET ORAL 20130912 ANDA ANDA076301 Shopko Stores Operating Co., LLC LORATADINE 10 mg/1 N 20181231 37012-626_0111e51d-63c3-43a6-8c55-9f7b96315a3c 37012-626 HUMAN OTC DRUG ShopKo Absolute Daily Moisturizing Broad Spectrum SPF15 Sunscreen Avobenzone, Homosalate, Octinoxate, Octocrylene CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Shopko Stores Operating Co., LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 3; 5; 2.6 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 37012-647_75b41d16-4837-49cf-9177-3bf36638f3c9 37012-647 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130912 ANDA ANDA072096 Shopko Stores Operating Co., LLC IBUPROFEN 200 mg/1 N 20191231 37012-656_702e6d88-0636-4225-a8eb-b84972cbe790 37012-656 HUMAN OTC DRUG Daytime Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20130805 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 37012-657_03dace6d-ec79-4506-acfe-47ce10822920 37012-657 HUMAN OTC DRUG Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20130613 OTC MONOGRAPH FINAL part332 Shopko Stores Operating Co., LLC DIMETHICONE 180 mg/1 N 20181231 37012-664_89b638ba-6d06-4595-a9c8-ac70f27178c5 37012-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20080102 OTC MONOGRAPH NOT FINAL part356 Shopko Store Operating Co, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37012-667_6c90d9f3-fb99-4f2e-ab97-554b6c684401 37012-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19890715 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co LLC MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 37012-668_7c462ae7-3927-477a-b57e-b4fa633a4933 37012-668 HUMAN OTC DRUG Nighttime Cough Relief Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20130819 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 37012-685_30e3d8fb-67bb-4c75-9af8-1cc14ec3093f 37012-685 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20160810 ANDA ANDA074937 Shopko Stores Operating Co., LLC IBUPROFEN 100 mg/5mL N 20181231 37012-724_cf3b5ddf-633a-400d-9d13-996ff10fa9a5 37012-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Shopko Stores Operating Co., LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 37012-726_b5651425-ce91-43c8-bc12-02c8a65b0dea 37012-726 HUMAN OTC DRUG ShopKo Absolute Daily Moisturizer SPF15 Sensitive Skin Octinoxate, Zinc Oxide, Avobenzone CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Shopko Stores Operating Co., LLC OCTINOXATE; ZINC OXIDE; AVOBENZONE 6; 3; 1 mg/100mL; mg/100mL; mg/100mL N 20181231 37012-731_d923ebdd-a031-4792-832e-e6af33c3ba9f 37012-731 HUMAN OTC DRUG Shopko Cherry SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Shopko PETROLATUM; PADIMATE O 44; 1.5 mg/g; mg/g N 20181231 37012-732_cd728da3-5da1-41c3-8752-d8b3daf381a5 37012-732 HUMAN OTC DRUG Shopko Original SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Shopko PETROLATUM; PADIMATE O 44; 1.5 mg/g; mg/g N 20181231 37012-733_9f196c4c-1100-4626-9051-7b9e1fe67215 37012-733 HUMAN OTC DRUG Shopko Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Shopko OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g N 20181231 37012-734_8b92923f-8dff-4736-b1fb-35ac03f82bcb 37012-734 HUMAN OTC DRUG Shopko Camphor Phenol Gel Camphor, Phenol GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part346 Shopko CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 mg/g; mg/g N 20181231 37012-735_dd46770d-b1e3-4488-b31c-c2e1a461936e 37012-735 HUMAN OTC DRUG Shopko Medicated Lip Treatment Camphor, Phenol GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part346 Shopko CAMPHOR (SYNTHETIC); MENTHOL 1.7; .7 mg/g; mg/g N 20181231 37012-736_5c674aab-067d-48bf-a839-a4aca4c01466 37012-736 HUMAN OTC DRUG Shopko Lip Treatment Petrolatum GEL TOPICAL 20130502 OTC MONOGRAPH FINAL part347 Shopko PETROLATUM 99.98 mg/g N 20181231 37012-737_3dc95764-6f45-4f6e-9a4d-f08a84efd869 37012-737 HUMAN OTC DRUG Shopko Medicated Lip Balm Petrolatum STICK TOPICAL 20130311 OTC MONOGRAPH FINAL part347 Shopko PETROLATUM 41 mg/g N 20181231 37012-763_5d567bc0-53ae-4945-bd74-1cfb1f123272 37012-763 HUMAN OTC DRUG Nighttime severe Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20150902 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 37012-770_5aad77f6-e8d7-2194-e053-2991aa0a6ce0 37012-770 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET, COATED ORAL 20171101 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN 500 mg/1 N 20181231 37012-771_5aad553f-42f7-62cf-e053-2991aa0a17d1 37012-771 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20171101 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 37012-799_4a723c11-e96b-4816-b44b-938d73f96221 37012-799 HUMAN OTC DRUG Tussin DM Max Cough and Chest Congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20160803 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 37012-803_e6afcae0-d330-4311-b636-8832580221aa 37012-803 HUMAN OTC DRUG nicotine mini Nicotine Polacrilex LOZENGE ORAL 20150528 ANDA ANDA203690 Shopko Stores Operating Co., LLC NICOTINE 2 mg/1 N 20181231 37012-806_4671b433-a839-4932-98d8-7f671d28f580 37012-806 HUMAN OTC DRUG Mucus DM Max Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160810 ANDA ANDA091070 Shopko Stores Operating Co., LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 37012-810_3eedb9fd-22af-4650-b110-459d644f47dd 37012-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20080102 OTC MONOGRAPH NOT FINAL part333A Shopko Stores Operating Co ISOPROPYL ALCOHOL 500 mg/mL N 20181231 37012-815_82897622-4dc7-4154-8e3e-919214d20d2e 37012-815 HUMAN OTC DRUG Shopko Anti-Wrinkle and Firming Moisturizer Day Broad Spectrum SPF18 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Shopko Stores Operating Co., LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g N 20181231 37012-822_85ef1886-2d2e-4cce-8ee7-01e3830d2487 37012-822 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20080108 OTC MONOGRAPH FINAL part346 Shopko Stores Operating Co., LLC WITCH HAZEL 979 mg/mL N 20181231 37012-831_aeae5de8-6cd6-4ac4-b91b-746f328a2127 37012-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 20080102 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC MINERAL OIL 999 mg/mL N 20181231 37012-845_3f63b81d-f741-4012-bf3a-23724d754166 37012-845 HUMAN OTC DRUG 70% Rubbing Isopropyl Alcohol LIQUID TOPICAL 20080131 OTC MONOGRAPH NOT FINAL part333A ShopKo ISOPROPYL ALCOHOL 500 mg/mL N 20181231 37012-852_3e44548a-b9f6-4dd7-a969-f2bb3415b86c 37012-852 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130605 ANDA ANDA091429 Shopko Stores Operating Co., LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 37012-871_6838e76e-8867-4855-827d-d829b76f6490 37012-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20090122 OTC MONOGRAPH NOT FINAL part333A Shopko Stores Operating Co, LLC HYDROGEN PEROXIDE 30 mg/mL N 20181231 37012-882_c6156db9-9000-463c-92da-b1d670811987 37012-882 HUMAN OTC DRUG Infants Gas Relief Simethicone EMULSION ORAL 20131127 OTC MONOGRAPH FINAL part332 Shopko Stores Operating Co., LLC DIMETHICONE 20 mg/.3mL N 20181231 37012-897_622a8f02-5bb5-4ac8-a016-ea0a6eba9562 37012-897 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20130730 ANDA ANDA074937 Shopko Stores Operating Co., LLC IBUPROFEN 100 mg/5mL N 20191231 37012-898_1c7e11f2-c9a1-41e6-b11d-27425c832b9c 37012-898 HUMAN OTC DRUG esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170927 ANDA ANDA207193 Shopko Stores Operating Co., LLC ESOMEPRAZOLE 20 mg/1 N 20181231 37012-901_c61aa461-6afc-4288-a663-1025e48b43b4 37012-901 HUMAN OTC DRUG Nasal Oxymetazoline hydrochloride SPRAY NASAL 20160803 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 37012-915_ecf3eb44-a5ea-4026-883a-7cfdf4a7fc34 37012-915 HUMAN OTC DRUG Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20130605 NDA NDA022032 Shopko Stores Operating Co., LLC OMEPRAZOLE 20 mg/1 N 20181231 37012-927_28c365af-c8d0-4e39-ace1-58eb04f862a5 37012-927 HUMAN OTC DRUG Shopko Diaper Rash Maximum Strength Zinc Oxide CREAM TOPICAL 20131210 OTC MONOGRAPH FINAL part347 Shopko Stores Operating Co., LLC ZINC OXIDE 40 g/100g N 20181231 37012-939_42ca6e02-05a3-432f-82c9-80c0d9d83dcd 37012-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine TABLET ORAL 20071227 ANDA ANDA077498 Shopko Stores Operating Co., LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 37012-945_850f16cc-5219-49ec-9d4d-14b32b4ba1cd 37012-945 HUMAN OTC DRUG Body Wash triclosan LIQUID TOPICAL 20090318 OTC MONOGRAPH NOT FINAL part333A ShopKo Stores Operating Co., LLC TRICLOSAN 1.545 mg/mL N 20181231 37012-946_c4eb9184-82d9-4275-82c2-433a13b4c215 37012-946 HUMAN OTC DRUG Infants and Children Pain Relief Acetaminophen SUSPENSION ORAL 20160810 OTC MONOGRAPH NOT FINAL part343 Shopko Stores Operating Co., LLC ACETAMINOPHEN 160 mg/5mL N 20181231 37012-949_d03c3363-1381-4800-b5ea-49d9f32db572 37012-949 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20130605 OTC MONOGRAPH NOT FINAL part334 Shopko Stores Operating Co., LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 37012-950_a161c075-4c8c-4360-97b3-e8116b4cd350 37012-950 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130605 ANDA ANDA091429 Shopko Stores Operating Co., LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 37012-957_8cd69bb7-4c07-467a-a658-21b0aed5f9a3 37012-957 HUMAN OTC DRUG nicotine mini Nicotine Polacrilex LOZENGE ORAL 20150603 ANDA ANDA203690 Shopko Stores Operating Co., LLC NICOTINE 4 mg/1 N 20181231 37012-962_1b84fc41-8d70-4466-b323-4fad9274b68a 37012-962 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20120724 OTC MONOGRAPH NOT FINAL part333A Shopko Stores Operating Co., LLC TRICLOSAN .46 mg/mL N 20181231 37012-994_e25e57bc-9af6-4088-888b-28d002513873 37012-994 HUMAN OTC DRUG Day Time Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20130912 OTC MONOGRAPH FINAL part341 Shopko Stores Operating Co., LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 37205-009_e04faa2d-e2ae-4762-8eef-144fb209d906 37205-009 HUMAN OTC DRUG LEADER Camphor Spirit CAMPHOR (NATURAL) LIQUID TOPICAL 20120315 OTC MONOGRAPH FINAL part348 Cardinal Health CAMPHOR (NATURAL) 10 mL/100mL N 20181231 37205-012_2f67cbef-8c81-4d97-9085-de0f25211bb0 37205-012 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120509 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL 500 mg/mL N 20181231 37205-022_ad32b4cf-9095-410f-a709-986297484833 37205-022 HUMAN OTC DRUG LEADER Mild Iodine IODINE,SODIUM IODIDE, ALCOHOL TINCTURE TOPICAL 20120315 OTC MONOGRAPH FINAL part333A Cardinal Health IODINE; SODIUM IODIDE; ALCOHOL 2; 2.4; 47 mL/100mL; mL/100mL; mL/100mL N 20181231 37205-024_bf5dabfa-6e8f-4dc3-bd69-0fff7bbd00f1 37205-024 HUMAN OTC DRUG LEADER Castor CASTOR OIL OIL ORAL 20120315 OTC MONOGRAPH FINAL part334 Cardinal Health CASTOR OIL 100 mL/100mL N 20181231 37205-034_f8bb1520-34d2-4b2c-822b-d9e0d0f90f53 37205-034 HUMAN OTC DRUG Leader Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Cardinal Health ACETAMINOPHEN 650 mg/1 N 20181231 37205-069_d8fbda72-a2f0-4334-8a33-0eb1dddd4edc 37205-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19970621 OTC MONOGRAPH FINAL part347 Cardinal Health PETROLATUM 100 kg/100kg N 20181231 37205-102_4e9287f3-87a6-967b-8f68-b81821a4b2fe 37205-102 HUMAN OTC DRUG Bisacodyl Bisacodyl SUPPOSITORY RECTAL 19970910 OTC MONOGRAPH NOT FINAL part334 CARDINAL HEALTH, INC. BISACODYL 10 mg/1 N 20181231 37205-110_52c94d1a-41a4-4389-80be-3cd73be0806e 37205-110 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 19890621 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 37205-111_69493a94-f35d-42d3-ba4f-f851b8daaaff 37205-111 HUMAN OTC DRUG Original Formula Motion Sickness Relief DIMENHYDRINATE TABLET ORAL 20120626 OTC MONOGRAPH FINAL part336 Cardinal Health (Leader) 37205 DIMENHYDRINATE 50 mg/1 N 20181231 37205-112_89e6ffed-f8ac-4a8b-a33b-df3da26c6630 37205-112 HUMAN OTC DRUG Gas Relief Simethicone TABLET, CHEWABLE ORAL 19940728 OTC MONOGRAPH FINAL part332 CARDINAL HEALTH DIMETHICONE 80 mg/1 N 20181231 37205-117_f2f01039-1739-493f-8b6f-3c0e68c6bda3 37205-117 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA040829 Cardinal Health, Inc. CHLORPHENIRAMINE MALEATE 12 mg/1 N 20181231 37205-119_41936f0b-c098-4958-83c7-35a664034930 37205-119 HUMAN OTC DRUG Leader Infants Gas Relief Simethicone EMULSION ORAL 20100308 OTC MONOGRAPH FINAL part332 Cardinal Health DIMETHICONE 20 mg/.3mL N 20181231 37205-120_15d8a696-015f-4cd2-911d-9f93bf80ff6f 37205-120 HUMAN OTC DRUG Leader Maximum Strength Sleep Aid DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20120605 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 37205-122_d79aee73-493f-4cd8-811b-758fb81db928 37205-122 HUMAN OTC DRUG LEADER ORAL ANALGESIC BENZOCAINE GEL ORAL 20120501 OTC MONOGRAPH FINAL part333B CARDINAL HEALTH BENZOCAINE 20 g/100g N 20181231 37205-128_4487b7f9-9351-4b61-a246-1e890677014f 37205-128 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET ORAL 20111014 OTC MONOGRAPH NOT FINAL part334 Cardinal Health BISACODYL 5 mg/1 N 20181231 37205-130_31ba9070-83e2-453d-aa49-82c646e83c9c 37205-130 HUMAN OTC DRUG LEADER Caldyphen ZINC OXIDE, PRAMOXINE HYDROCHLORIDE LOTION TOPICAL 20120315 OTC MONOGRAPH FINAL part348 Cardinal Health ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 8; 1 mL/100mL; mL/100mL N 20181231 37205-134_3f12cba7-2772-4eb7-ac82-2a53d517c3ba 37205-134 HUMAN OTC DRUG Dry Eyes white petrolatum mineral oil OINTMENT OPHTHALMIC 20111115 OTC MONOGRAPH FINAL part349 Cardinal Health MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g E 20171231 37205-137_6e60afeb-8e96-48e1-82d1-6f6c354f2ef6 37205-137 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20111115 OTC MONOGRAPH FINAL part349 Cardinal Health POLYVINYL ALCOHOL 14 mg/mL E 20171231 37205-138_30886773-26c2-4293-98ff-232772e3490b 37205-138 HUMAN OTC DRUG LEADER RELIEF EYE TETRAHYDROZOLINE HCL, ZINC SULFATE SOLUTION/ DROPS OPHTHALMIC 20120104 OTC MONOGRAPH FINAL part349 CARDINAL HEALTH TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL N 20181231 37205-139_eceb29d3-53c3-4913-8b66-5857009a727c 37205-139 HUMAN OTC DRUG LEADER ORIGINAL FORMULA TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20120104 OTC MONOGRAPH FINAL part349 CARDINAL HEALTH TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 37205-155_429dcb15-50dc-279a-e054-00144ff8d46c 37205-155 HUMAN OTC DRUG Antiseptic Swab isopropyl alcohol SWAB TOPICAL 20021001 20181231 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL .7 mL/1 E 20171231 37205-160_81699cf8-4c9d-45de-a5a1-90326ec5e7a4 37205-160 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Cardinal Health CLOTRIMAZOLE 10 mg/g N 20181231 37205-162_ed973033-e46e-412a-aaee-9d3b7fad0c3c 37205-162 HUMAN OTC DRUG LEADER HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20120213 OTC MONOGRAPH NOT FINAL part348 CARDINAL HEALTH HYDROCORTISONE 1 g/100g N 20181231 37205-165_f57a5d47-98a9-49e3-9c40-341a99fdc241 37205-165 HUMAN OTC DRUG Leader Lice Killing Maximum Strength piperonyl butoxide, pyrethrum extract SHAMPOO TOPICAL 20070719 OTC MONOGRAPH FINAL part358G Cardinal Health PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 37205-178_01b65863-85e1-45b0-9457-7342fcd298e1 37205-178 HUMAN OTC DRUG Soothing Bath Treatment Colloidal Oatmeal POWDER TOPICAL 20050721 OTC MONOGRAPH FINAL part347 Cardinal Health OATMEAL 1 g/g E 20171231 37205-186_324ddc5e-ffdf-4fe4-9a38-74ea94794bcc 37205-186 HUMAN OTC DRUG LEADER Povidone - Iodine POVIDONE-IODINE SOLUTION TOPICAL 20120926 OTC MONOGRAPH FINAL part333E Cardinal Health POVIDONE-IODINE 10 g/100mL N 20181231 37205-196_a2ef9c7c-1149-4f94-ac6e-8d593a846b21 37205-196 HUMAN OTC DRUG Effervescent Antacid and Pain Relief ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET, EFFERVESCENT ORAL 20061201 OTC MONOGRAPH FINAL part343 Cardinal Health Inc. SODIUM BICARBONATE; ANHYDROUS CITRIC ACID; ASPIRIN 1916; 1000; 325 mg/1; mg/1; mg/1 N 20181231 37205-197_1bcd36d6-2965-49ec-a4a7-0e7f25a5af11 37205-197 HUMAN OTC DRUG LEADER ANTIFUNGAL TOLNAFTATE TOLNAFTATE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part333C CARDINAL HEALTH TOLNAFTATE 10 mg/g N 20181231 37205-203_294f840f-c5f4-4671-b347-1ed2b6dc0eea 37205-203 HUMAN OTC DRUG Leader Nicotine Nicotine GUM, CHEWING ORAL 20050525 ANDA ANDA076775 Cardinal Health NICOTINE 2 mg/1 N 20181231 37205-213_f1b28346-9338-4dfe-9752-002da637e239 37205-213 HUMAN OTC DRUG Leader Fiber Calcium polycarbophil TABLET, FILM COATED ORAL 20110502 OTC MONOGRAPH NOT FINAL part334 Cardinal Health CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 37205-215_be913622-4031-4129-bf19-335604b3e751 37205-215 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19921219 20200207 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 37205-218_cfacec36-6013-443a-85d8-0f45209a7bb5 37205-218 HUMAN OTC DRUG Effervescent Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20100701 OTC MONOGRAPH FINAL part341 Cardinal Health, Inc ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 N 20181231 37205-223_fc05700f-0a6b-4693-a3f4-3211606f660d 37205-223 HUMAN OTC DRUG Cromolyn Sodium Cromolyn Sodium SPRAY, METERED NASAL 20100703 ANDA ANDA075702 Cardinal Health CROMOLYN SODIUM 5.2 mg/mL N 20181231 37205-224_6b1fa448-895c-424f-8e31-af89caf79d88 37205-224 HUMAN OTC DRUG LEADER ADVANCED FORMULA DEXTRAN70, POLYETHYLENE GLYCOL, POVIDONE, TETRAHYDROZOLINE HCL SOLUTION OPHTHALMIC 20120104 OTC MONOGRAPH FINAL part349 CARDINAL HEALTH DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-227_7556c0e0-804a-4081-9394-5aacffb977b7 37205-227 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL .91 L/100L N 20181231 37205-228_02201bdb-58b9-4662-a2c0-5ff3efa4a1fc 37205-228 HUMAN OTC DRUG Leader Allerhist Clemastine fumarate TABLET ORAL 19970930 ANDA ANDA074512 Cardinal Health CLEMASTINE FUMARATE 1.34 mg/1 N 20181231 37205-241_6ceb7f4d-8c02-4c2f-8f68-1cad196c3c1b 37205-241 HUMAN OTC DRUG Leader Senna Laxative SENNOSIDES TABLET ORAL 20120301 OTC MONOGRAPH NOT FINAL part334 Cardinal Health SENNOSIDES A AND B 8.6 mg/1 N 20181231 37205-243_0f5aa7b6-1105-4435-905a-16e76525c62f 37205-243 HUMAN OTC DRUG Antibacterial Triclosan SOAP TOPICAL 20071019 OTC MONOGRAPH NOT FINAL part333A Cardinal Health TRICLOSAN .15 mL/100L N 20181231 37205-251_f291e3a1-8bf7-4189-873f-baac6fdb5db2 37205-251 HUMAN OTC DRUG Stool Softener plus Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20110616 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 37205-262_80b636cb-ea7c-47c7-a3c1-285403725b1c 37205-262 HUMAN OTC DRUG Leader All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 20120625 20180430 ANDA ANDA079096 Cardinal Health (Leader) 37205 NAPROXEN SODIUM 220 mg/1 E 20171231 37205-265_7bf2c411-23bf-422f-8550-0ed79e0fd805 37205-265 HUMAN OTC DRUG Leader Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120301 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) DOCUSATE SODIUM 100 mg/1 N 20181231 37205-266_601a503c-777a-2b03-e053-2a91aa0add90 37205-266 HUMAN OTC DRUG LEADER TRIPLE ANTIBIOTIC PLUS BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part333B CARDINAL HEALTH BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 37205-270_2ac81ed7-fc9f-4637-bfdc-e5c831ca0aa0 37205-270 HUMAN OTC DRUG Leader allergy Diphenhydramine Hydrochloride TABLET ORAL 19920511 OTC MONOGRAPH FINAL part341 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37205-272_ebd9fd55-b1a7-475b-93dc-7363249b672a 37205-272 HUMAN OTC DRUG LEADER HYDROCORTISONE WITH ALOE HYDROCORTISONE CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 CARDINAL HEALTH HYDROCORTISONE 1 g/100g N 20181231 37205-273_6364c769-6dfc-51e9-e053-2a91aa0a78f9 37205-273 HUMAN OTC DRUG LEADER TRIPLE ANTIBIOTIC BACITRACIN, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part333B CARDINAL HEALTH BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20191231 37205-275_f0d58a51-8ba7-4141-a3cd-63f7768cc1da 37205-275 HUMAN OTC DRUG LEADER BACITRACIN BACITRACIN OINTMENT TOPICAL 20120215 OTC MONOGRAPH FINAL part333B CARDINAL HEALTH BACITRACIN 500 [USP'U]/g N 20181231 37205-277_3c672e00-eab5-4d40-a7d8-3deb20a2578b 37205-277 HUMAN OTC DRUG Leader Allergy Diphenhydramine hydrochloride CAPSULE ORAL 19900415 OTC MONOGRAPH FINAL part341 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37205-278_601af339-4d49-e38c-e053-2991aa0a9f00 37205-278 HUMAN OTC DRUG LEADER ANTI ITCH MAXIMUM STRENGTH DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20120210 OTC MONOGRAPH NOT FINAL part348 CARDINAL HEALTH DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 37205-279_22632df8-5a39-4cdf-aa7c-c583bd956a74 37205-279 HUMAN OTC DRUG Leader Maximum Strength Invisible Acne Benzoyl Peroxide 10% CREAM TOPICAL 20080601 OTC MONOGRAPH FINAL part333D Cardinal Health BENZOYL PEROXIDE 100 mg/g N 20181231 37205-280_9ce5a983-67b8-4783-aa52-71dca5153f43 37205-280 HUMAN OTC DRUG Leader migraine formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20020516 ANDA ANDA075794 Cardinal Health ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 37205-281_a090349d-4704-4e33-b107-f0cbe47f61c1 37205-281 HUMAN OTC DRUG LEADER Caldyphen Clear PRAMOXINE HYDROCHLORIDE, ZINC ACETATE LOTION TOPICAL 20120315 OTC MONOGRAPH FINAL part348 Cardinal Health PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 1; .1 mL/100mL; mL/100mL N 20181231 37205-282_edfbb91b-8165-428b-8354-468bb6a7c00f 37205-282 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen SUSPENSION ORAL 20020508 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL N 20181231 37205-283_91722e5a-b285-41bc-ba95-c124233b8116 37205-283 HUMAN OTC DRUG Leader Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20020425 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL N 20181231 37205-292_cfd92a78-926a-4856-af13-7bcc80d514cd 37205-292 HUMAN OTC DRUG leader gas relief ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20020304 OTC MONOGRAPH FINAL part332 Cardinal Health DIMETHICONE 180 mg/1 N 20181231 37205-294_d2574c2c-a7d2-45f1-9eb4-ac0f315febc8 37205-294 HUMAN OTC DRUG Leader Maximum Strength Laxative Calcium Sennosides TABLET ORAL 20120301 OTC MONOGRAPH NOT FINAL part334 Cardinal Health SENNOSIDES A AND B 25 mg/1 N 20181231 37205-296_ef381da4-6fd9-41b7-87c8-620183f5d6da 37205-296 HUMAN OTC DRUG leader tioconastat 1 1 dose treatment Tioconazole OINTMENT VAGINAL 20080403 ANDA ANDA075915 Cardinal Health TIOCONAZOLE 6.5 g/100g N 20181231 37205-308_cdb94bdc-f01d-4cea-b07b-ad180c559ae2 37205-308 HUMAN OTC DRUG LEADER Azo Tabs Urinary Tract Analgesic PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20041105 UNAPPROVED DRUG OTHER Cardinal Health PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 37205-311_1a7fb727-241a-4991-81b3-b9686b28b9eb 37205-311 HUMAN OTC DRUG Dandruff Shampoo PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 19980519 OTC MONOGRAPH FINAL part358 Cardinal Health PYRITHIONE ZINC 1 kg/100L N 20181231 37205-314_a10d7fe4-8f21-4adb-95f6-e93e50f9a7ba 37205-314 HUMAN OTC DRUG Leader Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20021030 OTC MONOGRAPH FINAL part332 Cardinal Health ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 37205-318_e997e4fd-04a1-4caf-a74d-b7787b8846c1 37205-318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL, Menthol, Methyl salicylate, thymol MOUTHWASH ORAL 19900813 OTC MONOGRAPH NOT FINAL part356 Cardinal Health EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-320_5cb10335-5132-c6cc-f3e3-34160c2d82b2 37205-320 HUMAN OTC DRUG Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20020403 OTC MONOGRAPH NOT FINAL part334 Cardinal Health GLYCERIN 2.1 g/1 N 20181231 37205-336_87ca88a1-819d-4af7-b852-3433f525e100 37205-336 HUMAN OTC DRUG LEADER SEVERE CONGESTION NASAL OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20120214 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL E 20171231 37205-338_0d56b8cd-1357-4bc3-99a8-2525de28eb86 37205-338 HUMAN OTC DRUG Anti-Itch Wal-Dryl Diphenhydramine HCl, Zinc Acetate SPRAY TOPICAL 20110802 OTC MONOGRAPH NOT FINAL part348 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 kg/100L; kg/100L N 20181231 37205-339_3c5b53ff-23e7-4a88-bb2e-a80111e7e359 37205-339 HUMAN OTC DRUG Leader Premenstrual ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE CAPSULE ORAL 20120228 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 37205-341_771a5428-cbc1-4886-884a-a9f772ba43bc 37205-341 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen TABLET, COATED ORAL 19900515 ANDA ANDA072096 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 37205-344_e606ab2f-28af-48f7-ab95-bf697e2d9f00 37205-344 HUMAN OTC DRUG Leader Medicated TOLNAFTATE AEROSOL, POWDER TOPICAL 20080315 OTC MONOGRAPH FINAL part333C Cardinal Health Inc. TOLNAFTATE 10 mg/g N 20181231 37205-345_d16da3c9-aaca-43a5-a572-3e99832ab68e 37205-345 HUMAN OTC DRUG Leader ibuprofen Ibuprofen TABLET, COATED ORAL 20060310 ANDA ANDA077349 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 37205-346_fe6bc6f0-dfff-49a9-8251-43dfa0a48df2 37205-346 HUMAN OTC DRUG LEADER Loratadine loratadine TABLET ORAL 20030819 ANDA ANDA076134 Cardinal Health LORATADINE 10 mg/1 N 20181231 37205-348_3c4eaae3-d16a-455b-98de-9fc32853bdb5 37205-348 HUMAN OTC DRUG Leader Allergy Relief D-24 Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Cardinal Health LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 37205-349_c0b5f157-67c5-49f3-9f69-19df4c8d10cb 37205-349 HUMAN OTC DRUG Leader Stool Softener plus Stimulant Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20120301 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 N 20181231 37205-350_0826599d-bd27-491e-bf26-4133e65e816e 37205-350 HUMAN OTC DRUG leader ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19900515 ANDA ANDA072096 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 37205-356_c169a638-49b1-4b56-8b09-394805faede5 37205-356 HUMAN OTC DRUG Medicated Chest Rub JELLY TOPICAL 20110123 OTC MONOGRAPH FINAL part341 Cardinal Health CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg N 20181231 37205-358_36deb649-005e-4971-ab69-57dbba14b06c 37205-358 HUMAN OTC DRUG LEADER NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Cardinal Health NICOTINE 21 mg/24h N 20181231 37205-360_36f29de8-76d1-414f-b99f-940429120caa 37205-360 HUMAN OTC DRUG Leader ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090427 ANDA ANDA079113 Cardinal Health DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 37205-361_36deb649-005e-4971-ab69-57dbba14b06c 37205-361 HUMAN OTC DRUG LEADER NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Cardinal Health NICOTINE 14 mg/24h N 20181231 37205-362_1c43d03e-d669-4a2b-84d8-971162bb3c2f 37205-362 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 19890621 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM CITRATE 1.745 g/29.6mg N 20181231 37205-363_36deb649-005e-4971-ab69-57dbba14b06c 37205-363 HUMAN OTC DRUG LEADER NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20120102 NDA NDA020076 Cardinal Health NICOTINE 7 mg/24h N 20181231 37205-370_424e360e-c596-4476-b0f9-ccaf1d34bded 37205-370 HUMAN OTC DRUG Leader Anti Diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20030402 ANDA ANDA075232 Cardinal Health LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 37205-372_1dee6273-cb24-44e8-bf3b-1e5d86416e72 37205-372 HUMAN OTC DRUG Leader Fiber Psyllium Husk CAPSULE ORAL 20110701 OTC MONOGRAPH NOT FINAL part334 Cardinal Health PSYLLIUM HUSK .52 g/1 N 20181231 37205-378_87d86d5d-97cf-4e52-8eae-d077a6506ae4 37205-378 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Cardinal Health LORATADINE 5 mg/5mL N 20181231 37205-402_019f2ddb-29cd-41b9-b7dd-7a96569febbf 37205-402 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20040528 ANDA ANDA076359 Cardinal Health IBUPROFEN 100 mg/1 N 20181231 37205-405_ece7db10-e0ae-40e3-a4be-c1f03a9dbb38 37205-405 HUMAN OTC DRUG LEADER HEMORRHOIDAL MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL OINTMENT TOPICAL 20120501 OTC MONOGRAPH FINAL part346 CARDINAL HEALTH MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 140; 719; 2.5; 30 mg/g; mg/g; mg/g; mg/g E 20171231 37205-436_aad9fcd0-6eb5-42d9-806c-685bf103ed7b 37205-436 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20040719 ANDA ANDA075217 Cardinal Health IBUPROFEN 50 mg/1.25mL N 20181231 37205-445_5c332765-71cd-4b46-8105-62153e9f63ef 37205-445 HUMAN OTC DRUG leader nasal decongestant maximum strength Pseudoephedrine HCl TABLET, FILM COATED ORAL 19900615 OTC MONOGRAPH FINAL part341 Cardinal Health PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 37205-446_b46a956d-200b-42b9-b996-344d2950aea9 37205-446 HUMAN OTC DRUG Leader 12 Hour Nasal Decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19990721 ANDA ANDA075153 Cardinal Health PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 37205-457_3d11e5b3-e48c-44db-9ac9-2ead513b8983 37205-457 HUMAN OTC DRUG Earwax Removal Aid Earwax Removal Aid LIQUID AURICULAR (OTIC) 20120206 OTC MONOGRAPH FINAL part344 Cardinal Health CARBAMIDE PEROXIDE 6.5 mg/100mL E 20171231 37205-458_cf66eb79-e208-439a-b2cd-444fe2025ce3 37205-458 HUMAN OTC DRUG Earwax Removal Kit Earwax Removal Kit LIQUID AURICULAR (OTIC) 20120206 OTC MONOGRAPH FINAL part344 Cardinal Health CARBAMIDE PEROXIDE 6.5 mg/100mL E 20171231 37205-466_788980a2-1879-4e9d-98a7-424667b2138a 37205-466 HUMAN OTC DRUG Leader Cough Tabs Guaifenesin TABLET ORAL 20050301 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 200 mg/1 N 20181231 37205-467_8aec44d2-0134-4138-b3e0-dfaf256007ae 37205-467 HUMAN OTC DRUG leader aspirin Aspirin TABLET, CHEWABLE ORAL 19930809 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ASPIRIN 81 mg/1 N 20181231 37205-473_1a479976-afea-4770-ae68-affa14710d0d 37205-473 HUMAN OTC DRUG leader nasal decongestant pe maximum strength Phenylephrine Hydrochloride TABLET ORAL 20050504 OTC MONOGRAPH FINAL part341 Cardinal Health PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 37205-476_039aab42-4dab-48d4-a1d3-7f83ca9b51b4 37205-476 HUMAN OTC DRUG Leader Chest Congestion Relief G450 Guaifenesin TABLET ORAL 20050301 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 400 mg/1 N 20181231 37205-477_6cac2800-03b0-4469-baaf-e47e018035de 37205-477 HUMAN OTC DRUG Leader 8 Hour Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Cardinal Health ACETAMINOPHEN 650 mg/1 N 20181231 37205-483_c2d6b968-f170-4052-8bf3-4aea48db92b1 37205-483 HUMAN OTC DRUG leader nose Phenylephrine hydrochloride LIQUID NASAL 20050706 OTC MONOGRAPH FINAL part341 Cardinal Health PHENYLEPHRINE HYDROCHLORIDE 1 mL/100mL N 20181231 37205-516_62013d8c-8993-4fe7-b65e-02b273673d86 37205-516 HUMAN OTC DRUG Childrens Pain Reliever Acetaminophen TABLET, CHEWABLE ORAL 20050203 20200829 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN 80 mg/1 N 20181231 37205-530_05c703c1-ff79-4b21-998d-4eb5113cfe59 37205-530 HUMAN OTC DRUG Leader Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 19900415 OTC MONOGRAPH FINAL part332 Cardinal Health ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 37205-535_ad9a5911-1345-4f12-8211-c2957bf14010 37205-535 HUMAN OTC DRUG Leader Antacid Maximum Strength aluminum hydroxide, magnesium hydroxide, simethicone SUSPENSION ORAL 19900515 OTC MONOGRAPH FINAL part331 Cardinal Health ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 37205-536_17c58900-ffcf-4d28-82d7-be3bc48fbe0b 37205-536 HUMAN OTC DRUG Leader Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone SUSPENSION ORAL 20060123 OTC MONOGRAPH FINAL part332 Cardinal Health ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 37205-538_fcf14716-2b16-4d80-9ab3-e9a05bd9bef7 37205-538 HUMAN OTC DRUG Leader Chest Congestion Relief Plus DMDM DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20061220 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 37205-565_0e70e257-5dd1-4a7e-8416-e73e87755004 37205-565 HUMAN OTC DRUG Leader Childrens Allergy Diphenhydramine Hydrochloride SOLUTION ORAL 19900515 OTC MONOGRAPH FINAL part341 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 37205-570_5fe8e27a-ca58-48c1-ac51-468a24fa8b7e 37205-570 HUMAN OTC DRUG Leader Childrens Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Cardinal Health LORATADINE 5 mg/5mL N 20181231 37205-571_22b80383-1b9c-449a-9571-174893b4f7aa 37205-571 HUMAN OTC DRUG leader sinus congestion and pain daytime non drowsy Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070112 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 37205-575_243aeb14-1e47-47c2-bc74-a35e22c73926 37205-575 HUMAN OTC DRUG leader infants pain and fever Acetaminophen SUSPENSION ORAL 20120625 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL N 20181231 37205-576_96eeebd7-5c8c-45b9-8b70-58012358e86e 37205-576 HUMAN OTC DRUG Leader Pain and Fever Infants Acetaminophen SUSPENSION ORAL 20120815 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL N 20181231 37205-577_76b942f0-dc75-4584-8480-26e9b00206b0 37205-577 HUMAN OTC DRUG leader pain and fever acetaminophen SUSPENSION ORAL 20120625 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL N 20181231 37205-583_ee5df4e6-15af-4234-b49a-76b39e8b7965 37205-583 HUMAN OTC DRUG Miconazole 3 Combination Pack miconazole nitrate KIT VAGINAL 20021202 ANDA ANDA074926 Cardinal Health E 20171231 37205-584_04bd5119-522e-488b-ab2b-5d18a4e4521a 37205-584 HUMAN OTC DRUG Leader Loperamide Hydrochloride loperamide HCl LIQUID ORAL 20120328 ANDA ANDA091292 Cardinal Health LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 37205-585_f8c9acd3-cc9e-4b0a-8033-5bb9aba3f7ed 37205-585 HUMAN OTC DRUG leader hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20120316 ANDA ANDA091344 Cardinal Health MINOXIDIL 5 g/100g N 20181231 37205-586_9ecb5062-0e07-4181-a2a1-2bd7154a5cbb 37205-586 HUMAN OTC DRUG leader nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20111130 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 37205-587_e5595a8c-00c1-4dfc-bfc3-a79d6273b67a 37205-587 HUMAN OTC DRUG leader nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20111102 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 37205-589_7aedb0ac-be45-496f-822f-f3f13bc4b742 37205-589 HUMAN OTC DRUG Miconazole 3 Combination Pack miconazole nitrate KIT VAGINAL 20010202 ANDA ANDA074926 CARDINAL HEALTH N 20181231 37205-590_90f4c811-0f40-659f-f9f5-5c57a4ff74c2 37205-590 HUMAN OTC DRUG 7 DAY VAGINAL Miconazole Nitrate CREAM TOPICAL 20090316 OTC MONOGRAPH FINAL part333C Cardinal Health MICONAZOLE NITRATE 2 g/100g N 20181231 37205-591_5f7f713f-89c8-40ac-b47c-30619ce0c05c 37205-591 HUMAN OTC DRUG Leader Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Cardinal Health CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 37205-593_88cd3bab-1ca6-4fb7-8afe-ca363cc7fc14 37205-593 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20051211 20200829 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN 500 mg/1 N 20181231 37205-594_e8961138-5616-4f99-8bd0-9f843651dcbd 37205-594 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN 500 mg/1 N 20181231 37205-595_2820d2e4-b927-6046-e054-00144ff8d46c 37205-595 HUMAN PRESCRIPTION DRUG ANTISEPTIC SKIN CLEANSER CHLORHEXIDINE GLUCONATE SOLUTION TOPICAL 20120101 NDA NDA019125 Cardinal Health CHLORHEXIDINE GLUCONATE 4 g/100mL Decreased Cell Wall Integrity [PE] N 20181231 37205-602_d9db2e8d-4b50-49a5-a5c2-050646250511 37205-602 HUMAN OTC DRUG Epsom Salt MAGNESIUM SULFATE CRYSTAL ORAL; TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 37205-603_2e5705e8-ca97-48df-a06f-3e9c7bff189d 37205-603 HUMAN OTC DRUG LEADER DRY EYE RELIEF DEXTRAN, HYPROMELLOSE 2910 SOLUTION OPHTHALMIC 20120104 OTC MONOGRAPH FINAL part349 CARDINAL HEALTH DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) .001; .003 mL/mL; mL/mL N 20181231 37205-605_203e95e7-436c-4957-8b15-61766b6fea6f 37205-605 HUMAN OTC DRUG Leader ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19901015 ANDA ANDA077349 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 37205-607_de03e285-4967-460e-8843-0b874dd1d203 37205-607 HUMAN OTC DRUG Leader Oral Pain Relief Anesthetic Benzocaine 20% GEL ORAL 20120808 OTC MONOGRAPH FINAL part356 Cardinal Health BENZOCAINE 200 mg/g N 20181231 37205-610_c8774bd2-0b32-4545-ad0a-f2df8f85aab7 37205-610 HUMAN OTC DRUG LEADER iNTENSE COUGH RELIEVER Dextromethorphan Hydrobromide / Guaifenesin LIQUID ORAL 20110802 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 300 mg/5mL; mg/5mL N 20181231 37205-612_67cda6a2-6996-4f81-8dfa-4c1db816f761 37205-612 HUMAN OTC DRUG Leader Clear Lax original prescription strength Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091026 ANDA ANDA090685 Cardinal Health POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 37205-613_ee2d253f-7730-4e59-bc4a-af6f17a2ddad 37205-613 HUMAN OTC DRUG Burn Relief Leader Lidocaine SPRAY TOPICAL 20111201 OTC MONOGRAPH FINAL part348 Cardinal Health LIDOCAINE .05 g/100g N 20181231 37205-614_47c3812f-08cb-48c1-8a26-2f0c06f58922 37205-614 HUMAN OTC DRUG leader acid reducer original strength Famotidine TABLET ORAL 20091014 ANDA ANDA075400 Cardinal Health FAMOTIDINE 10 mg/1 N 20181231 37205-615_9a947944-98d3-4c56-b43d-06271ced2400 37205-615 HUMAN OTC DRUG Ear Wax Removing Drops Carbamide Peroxide Leader LIQUID AURICULAR (OTIC) 20111201 OTC MONOGRAPH FINAL part344 Cardinal Health CARBAMIDE PEROXIDE 6.5 g/100mL N 20181231 37205-616_217355e0-291c-4ebe-b7ef-edc1b8c113f0 37205-616 HUMAN OTC DRUG Ice External Analgesic Leader Menthol GEL TOPICAL 20111201 OTC MONOGRAPH FINAL part348 Cardinal Health MENTHOL .02 g/100g N 20181231 37205-617_75302b1c-95f1-4bf9-a151-db8fb5bb45f3 37205-617 HUMAN OTC DRUG Ear Dry Leader Isopropyl Alcohol, Glycerin LIQUID AURICULAR (OTIC) 20111201 OTC MONOGRAPH FINAL part344 Cardinal Health ISOPROPYL ALCOHOL; GLYCERIN 94.998; 5 g/100mL; g/100mL N 20181231 37205-625_eed56fc4-90b1-41c6-90b1-25ff694bd277 37205-625 HUMAN OTC DRUG Leader Medicated Wipes witch hazel SOLUTION TOPICAL 20100413 OTC MONOGRAPH FINAL part346 Cardinal Health WITCH HAZEL .5 mL/mL E 20171231 37205-628_c3e0c180-b33e-44c9-a501-fd8f85a27d07 37205-628 HUMAN OTC DRUG leader mucus er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130319 ANDA ANDA078912 Cardinal Health GUAIFENESIN 600 mg/1 N 20181231 37205-629_4f6bb292-e596-4c97-bd5f-585ffba507d9 37205-629 HUMAN OTC DRUG Leader tussin dm max adult Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20100413 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 37205-630_87e1c262-9d7b-4fbc-93be-6d527827441e 37205-630 HUMAN OTC DRUG LEADER MAXIMUM STRENGHT URINARY PAIN RELIEF PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20090430 UNAPPROVED DRUG OTHER Cardinal Health PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 37205-635_e49bba87-8b58-4d73-aca3-3132ac65d0e4 37205-635 HUMAN OTC DRUG LEADER LUBRICATING EYE CARBOXYMETHYLCELLULOSE SODIUM, AND GLYCERIN SOLUTION/ DROPS OPHTHALMIC 20120104 OTC MONOGRAPH FINAL part349 CARDINAL HEALTH CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 37205-636_efc2f3b1-c5bd-46d5-976e-9db7922aaef7 37205-636 HUMAN OTC DRUG LEADER LUBRICANT EYE DROPS POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL SOLUTION OPHTHALMIC 20120104 OTC MONOGRAPH FINAL part349 CARDINAL HEALTH POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mL/mL; mL/mL N 20181231 37205-637_1354cdf4-4ca9-4c66-9051-1ca5acc66a7b 37205-637 HUMAN OTC DRUG LEADER DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20120120 OTC MONOGRAPH FINAL part347 CARDINAL HEALTH ZINC OXIDE .4 g/g N 20181231 37205-640_d99a5024-75e1-4100-b102-36f3bbb18d13 37205-640 HUMAN OTC DRUG leader miconazole 1 Miconazole nitrate KIT 20110119 ANDA ANDA079114 Cardinal Health N 20181231 37205-641_9e5604b2-fb26-4725-9c93-66ba917eecd6 37205-641 HUMAN OTC DRUG LEADER CAPSAICIN CAPSAICIN CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 CARDINAL HEALTH CAPSAICIN .1 g/100g E 20171231 37205-643_bd124df8-1620-4276-b9be-f07902eec817 37205-643 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen SUSPENSION ORAL 19990128 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL N 20181231 37205-648_5fdb945a-fc9e-dba0-e053-2a91aa0a25ab 37205-648 HUMAN OTC DRUG Decolorized Iodine Ethyl Alcohol LIQUID TOPICAL 19790101 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ALCOHOL .45 mL/mL N 20181231 37205-650_094465af-c28c-444d-a633-dee6afc73d7d 37205-650 HUMAN OTC DRUG leader aller ease fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110516 ANDA ANDA076447 Cardinal Health FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 37205-653_caeacf73-1f2f-48e1-a8c3-0525a46b560b 37205-653 HUMAN OTC DRUG Leader Medicated Miconazole nitrate POWDER TOPICAL 20101031 OTC MONOGRAPH FINAL part333C Cardinal Health Inc. MICONAZOLE NITRATE 1.42 g/71g N 20181231 37205-659_0def77e9-5493-4eec-8d14-dc5e5697bbec 37205-659 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN 500 mg/1 N 20181231 37205-660_75431172-3716-47a5-8191-ab58ebc75c00 37205-660 HUMAN OTC DRUG Leader ibuprofen Ibuprofen SUSPENSION ORAL 20020425 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL N 20181231 37205-661_bf5fabbc-8e2e-414a-98c1-afc44dd76328 37205-661 HUMAN OTC DRUG Leader Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120530 ANDA ANDA202319 Cardinal Health LANSOPRAZOLE 15 mg/1 N 20181231 37205-662_bc9938dd-9ee4-49c2-a80e-bc90d0ca6646 37205-662 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, EXTENDED RELEASE ORAL 20121221 ANDA ANDA078569 Cardinal Health ACETAMINOPHEN 650 mg/1 N 20181231 37205-664_07ce0282-64a7-4732-9de7-7d857cd5062d 37205-664 HUMAN OTC DRUG Antiseptic Mouth Rinse MOUTHWASH ORAL 19970615 OTC MONOGRAPH NOT FINAL part356 Cardinal Health EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L N 20181231 37205-665_80593224-fcaf-4063-a655-dcb0df64f63e 37205-665 HUMAN OTC DRUG Leader Natural Fiber Psyllium Husk POWDER ORAL 20120701 OTC MONOGRAPH NOT FINAL part334 Cardinal Health PSYLLIUM HUSK 3.4 g/5.8g N 20181231 37205-666_29e631b1-c71b-42f5-bc5a-c329a453d91e 37205-666 HUMAN OTC DRUG Leader Natural Fiber Psyllium Husk POWDER ORAL 20120701 OTC MONOGRAPH NOT FINAL part334 Cardinal Health PSYLLIUM HUSK 3.4 g/5.8g N 20181231 37205-667_32e16af2-5b8e-4c96-b5a0-7ec0e2b2d7ac 37205-667 HUMAN OTC DRUG Leader Natural Fiber Psyllium Husk POWDER ORAL 20120701 OTC MONOGRAPH NOT FINAL part334 Cardinal Health PSYLLIUM HUSK 3.4 g/5.8g N 20181231 37205-668_e58b6263-48ac-4901-9ec7-cab75277af1b 37205-668 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 20200828 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 325 mg/1 N 20181231 37205-670_719b6526-4dcc-462b-888f-20e80a046fa9 37205-670 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 CARDINAL HEALTH IBUPROFEN 200 mg/1 N 20181231 37205-671_68a31c52-9505-4918-a515-f39e94930326 37205-671 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 20020411 20200221 ANDA ANDA040564 CARDINAL HEALTH DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 37205-672_8ed76376-ca12-4a72-a047-dac9be323872 37205-672 HUMAN OTC DRUG leader ibuprofen pm Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20120613 ANDA ANDA079113 Cardinal Health DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 37205-674_56d3eb7a-5a8c-4cf3-acef-9204fb674617 37205-674 HUMAN OTC DRUG Leader TabTussin 400 Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 400 mg/1 N 20181231 37205-674_d7dcac42-60c8-4d7e-b547-fec1f5507854 37205-674 HUMAN OTC DRUG Leader TabTussin 400 Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 400 mg/1 N 20181231 37205-675_fe8524f9-e17b-4a00-9fed-7fae48734deb 37205-675 HUMAN OTC DRUG Leader TabTussin DM TDM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 37205-676_6611c514-ae7e-476b-9bab-08ec4eccf4e2 37205-676 HUMAN OTC DRUG leader childrens pain and fever Acetaminophen SUSPENSION ORAL 20120717 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL N 20181231 37205-677_47cdb47c-b249-497d-b8dc-8f1372c50991 37205-677 HUMAN OTC DRUG leader headache pm formula Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120625 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 37205-678_8b0489e4-171c-4c17-a062-b2ad54c2b601 37205-678 HUMAN OTC DRUG leader flu and severe cold and cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120613 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 37205-680_88ffeef7-f1ee-4e1c-9db0-2386a02b64d1 37205-680 HUMAN OTC DRUG leader acid reducer complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20120426 ANDA ANDA077355 Cardinal Health FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 37205-681_4bd2bfca-244c-4ae7-85c6-906dc46575b9 37205-681 HUMAN OTC DRUG leader acid reducer complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20120502 ANDA ANDA077355 Cardinal Health FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 37205-683_1e9baf1a-c0aa-44b8-b0af-0ac531c9c529 37205-683 HUMAN OTC DRUG Anti-Itch Men-Phor LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part356 CARDINAL HEALTH MENTHOL; CAMPHOR (SYNTHETIC) .5; .5 g/g; g/g N 20181231 37205-684_caed4b9c-2730-4c76-b6bf-33d534c64282 37205-684 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Cardinal Health PYRITHIONE ZINC 1 kg/100L N 20181231 37205-686_f3a70619-87f3-4328-b842-b72f5f0d20ca 37205-686 HUMAN OTC DRUG leader tussin dextromethorphan hbr, guaifenesin SUSPENSION ORAL 20120813 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 37205-692_b0356d7d-86de-4d8f-beaf-6b5ffc68ab51 37205-692 HUMAN OTC DRUG Leader Cherry SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH FINAL part352 Cardinal Health (Leader) PETROLATUM; PADIMATE O 44; 1.5 mg/g; mg/g N 20181231 37205-693_2d25b07b-1e0a-4960-8c00-a40f0b9c7070 37205-693 HUMAN OTC DRUG Leader Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Cardinal Health (Leader) OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g N 20181231 37205-694_1ee52c1a-6295-4ff4-ab70-035b96325c0d 37205-694 HUMAN OTC DRUG Leader Original SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Cardinal Health (Leader) PETROLATUM; PADIMATE O 44; 1.5 mg/g; mg/g N 20181231 37205-695_ee391680-3831-417f-b1e9-a945153052db 37205-695 HUMAN OTC DRUG leader nite time cough Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130428 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 37205-696_5fecf3bb-f5ed-48f6-ac4c-ae7207d242a5 37205-696 HUMAN OTC DRUG leader tussin cf max dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20121226 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 37205-697_067f9b5e-0595-47d9-81da-197575300fda 37205-697 HUMAN OTC DRUG leader cough dm dextromethorphan polistirex SUSPENSION ORAL 20120913 ANDA ANDA091135 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 37205-698_3fcf2942-ef1a-429c-8cd3-09dd3ef25e38 37205-698 HUMAN OTC DRUG leader cough dm dextromethorphan polistirex SUSPENSION ORAL 20130604 ANDA ANDA091135 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 37205-705_59fda34b-0b86-4555-8721-251fed7dd390 37205-705 HUMAN OTC DRUG Leader Day Time Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20061006 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 37205-706_ffcb6e47-62d3-4eed-9f2d-386b7ec3b5a0 37205-706 HUMAN OTC DRUG leader antacid Calcium carbonate TABLET, CHEWABLE ORAL 19970529 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 750 mg/1 N 20181231 37205-708_202f3fbe-8609-450d-be9b-10dc1781b2b8 37205-708 HUMAN OTC DRUG leader aspirin Aspirin TABLET, CHEWABLE ORAL 19970402 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ASPIRIN 81 mg/1 N 20181231 37205-709_0b52efd5-63d7-40c8-86b2-43b5927311ff 37205-709 HUMAN OTC DRUG leader tussin cf Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060425 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 37205-712_7200d1d8-3516-4f18-9763-ea561b436b2b 37205-712 HUMAN OTC DRUG Leader Adult Tussin DM Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19970605 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 37205-715_f0805ebc-17e6-3c36-34ca-f4fa92c7e9e2 37205-715 HUMAN OTC DRUG LEADER HEMORRHOIDAL Phenylephrine Hydrochloride, Hard Fat SUPPOSITORY RECTAL 20090312 OTC MONOGRAPH FINAL part346 CARDINAL HEALTH, INC. PHENYLEPHRINE HYDROCHLORIDE; FAT, HARD 5.77; 1881 mg/1; mg/1 N 20181231 37205-719_66040315-54c8-464a-9654-6926b8e9f736 37205-719 HUMAN OTC DRUG leader day time multi symptom cold flu relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20060801 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 37205-721_db355bf4-74f1-40d4-9159-9cd3d4429787 37205-721 HUMAN OTC DRUG Leader Baby Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 57.5; 72.1; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-722_1298fda2-c7f7-472a-854a-f39162b03e56 37205-722 HUMAN OTC DRUG Leader Dark Tanning SPF 4 Octinoxate, Oxybenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health OCTINOXATE; OXYBENZONE 16.6; 4.15 mg/mL; mg/mL N 20181231 37205-723_9fbea52c-d538-4e79-b738-ed47b912a370 37205-723 HUMAN OTC DRUG Leader Kids SPF 50 Sunscreen Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 100; 50; 40; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-724_8c747897-d450-43db-a9b5-1e8a99673c2d 37205-724 HUMAN OTC DRUG Leader Kids SPF 90 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27.75; 138.75; 46.25; 92.5; 55.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-725_3258194e-53b9-4ae5-a2b8-7bc5d3b7525f 37205-725 HUMAN OTC DRUG Leader Sport Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.6; 132.6; 51; 51; 61.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-726_1fa8b699-a01c-409d-b93d-a9e549e9f4b9 37205-726 HUMAN OTC DRUG Leader Sport SPF 30 Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 87; 43.5; 17.4; 34.8; 26.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-727_9fc8c582-5633-459b-b16a-40e2452f6cad 37205-727 HUMAN OTC DRUG Leader Sport SPF 50 Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 85; 42.5; 34; 42.5; 25.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-728_1512bc8e-7e53-40c4-af51-994117c5ff83 37205-728 HUMAN OTC DRUG Leader General Protection Sunscreen SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20.4; 107.1; 51; 20.4; 20.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-729_46090fb4-9718-4667-89cb-7f0a98023ecb 37205-729 HUMAN OTC DRUG Leader General Protection Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.6; 132.6; 51; 71.4; 40.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-730_5be4dce8-c477-43cb-ad3f-2e7243e6d69e 37205-730 HUMAN OTC DRUG Leader GP SPF 15 CS Homosalate, Octisalate, Oxybenzone, Avobenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE 87; 43.5; 26.1; 17.4 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-731_5e83707e-f5c4-438f-bf51-a31a4dc5cd67 37205-731 HUMAN OTC DRUG Leader General Protection SPF 30 Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 87; 43.5; 17.4; 34.8; 26.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-732_eb22c509-169c-4007-a2e2-a269c7fa3ac3 37205-732 HUMAN OTC DRUG Leader General Protection SPF 70 Homosalate, Octisalate, Oxybenzone, Octocrylene, Avobenzone AEROSOL, SPRAY TOPICAL 20120115 OTC MONOGRAPH NOT FINAL part352 Cardinal Health HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 130.5; 43.5; 87; 57.2; 26.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37205-733_23da822f-e315-4943-b807-32025debec62 37205-733 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20121109 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ALCOHOL 70 mL/100mL N 20181231 37205-734_f86149fb-7da1-4ab4-ad05-70e76142b612 37205-734 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20121109 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ALCOHOL 700 mL/100mL N 20181231 37205-735_8e61b7f5-7998-41db-b8dd-51c1608d84dc 37205-735 HUMAN OTC DRUG LEADER ORIGINAL NASAL OXYMETAZOLINE HYDROCHOLORIDE SPRAY NASAL 20120930 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL E 20171231 37205-736_32779c3a-17a5-4076-8cf4-76bb4531c242 37205-736 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20121211 ANDA ANDA078682 Cardinal Health (Leader) IBUPROFEN 200 mg/1 N 20181231 37205-738_85dcd1f7-a8ca-41c4-826d-edcce1d97fa2 37205-738 HUMAN OTC DRUG Menstrual Complete Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET, FILM COATED ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 37205-739_57f63e2c-928d-4a0c-8708-bc3cafdfb62b 37205-739 HUMAN OTC DRUG LEADER MEDICATED PADS WITCH HAZEL SOLUTION TOPICAL 20120401 OTC MONOGRAPH FINAL part346 CARDINAL HEALTH WITCH HAZEL .5 mL/mL N 20181231 37205-741_3bef5f79-1f57-4492-89df-71d1aead8fbb 37205-741 HUMAN OTC DRUG LEADER MEDICATED WIPE WITCH HAZEL SOLUTION TOPICAL 20120301 OTC MONOGRAPH FINAL part346 CARDINAL HEALTH WITCH HAZEL 5 g/1 N 20181231 37205-742_6e4d603d-f170-49a8-9cea-987f83a6c63c 37205-742 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine HCl CAPSULE ORAL 20120830 OTC MONOGRAPH FINAL part336 Cardinal Health (Leader) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37205-743_b0c8adb3-99e1-4f22-936d-b280ddce871a 37205-743 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20121030 OTC MONOGRAPH FINAL part336 Cardinal Health (Leader) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37205-744_9d9889c0-5f16-49d0-a37b-ad1402f272aa 37205-744 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20120830 ANDA ANDA079096 Cardinal Health (Leader) NAPROXEN SODIUM 220 mg/1 N 20181231 37205-745_7cafc926-850f-4d74-bd87-f5e45bc29600 37205-745 HUMAN OTC DRUG Allergy Relief Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Cardinal Health LORATADINE 10 mg/1 N 20181231 37205-750_c1a7774c-d565-4bc4-a2c9-023789ac01b1 37205-750 HUMAN OTC DRUG Arthritis Leader Trolamine Salicylate CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part348 Cardinal Health TROLAMINE SALICYLATE 10 g/100g N 20181231 37205-751_7c55f702-e86e-4dd5-9624-e636fc1c1526 37205-751 HUMAN OTC DRUG Leader Camphor Phenol Gel Camphor, Phenol GEL TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Cardinal Health (Leader) CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 mg/g; mg/g N 20181231 37205-752_f0cd0e37-32dd-4baf-902b-e26f1c4d0164 37205-752 HUMAN OTC DRUG Kettle Neti Pot SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION ORAL 20130401 UNAPPROVED DRUG OTHER Cardinal Health 414, LLC SODIUM BICARBONATE; SODIUM CHLORIDE 700; 2300 mg/1; mg/1 N 20181231 37205-753_a29d6d05-a22d-4eca-9e2c-e791d89e9655 37205-753 HUMAN OTC DRUG Saline Refills SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION ORAL 20130401 UNAPPROVED DRUG OTHER Cardinal Health 414, LLC SODIUM BICARBONATE; SODIUM CHLORIDE 2300; 700 mg/1; mg/1 N 20181231 37205-754_d63687bb-977a-4e29-9bb2-c808d9899e87 37205-754 HUMAN OTC DRUG Leader Enema Saline ENEMA RECTAL 20130219 OTC MONOGRAPH NOT FINAL part334 CARDINAL HEALTH, INC. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 37205-755_5ee66de4-ff5f-4a96-b42b-b00f8056a247 37205-755 HUMAN OTC DRUG Leader Mineral Oil Mineral Oil ENEMA RECTAL 20130219 OTC MONOGRAPH NOT FINAL part334 CARDINAL HEALTH, INC. MINERAL OIL 118 mL/118mL E 20171231 37205-756_46e3ba43-98cc-499d-b542-c49f4f0cbb3f 37205-756 HUMAN OTC DRUG Cold Head Congestion Daytime Non-Drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20050715 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 37205-757_d49cc977-fc5d-47f4-ad9c-66b2c4c798ef 37205-757 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130413 20180331 OTC MONOGRAPH FINAL part343 Cardinal Health (Leader) 37205 ASPIRIN 81 mg/1 N 20181231 37205-759_2850b1bb-db49-4aca-981b-96aa7ae6d7f3 37205-759 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 37205-760_cda47ef7-0293-4154-9d2d-5fd2db1f7011 37205-760 HUMAN OTC DRUG Leader Clotrimazole Anti-Fungal CLOTRIMAZOLE CREAM TOPICAL 20130531 OTC MONOGRAPH FINAL part333C Cardinal Health CLOTRIMAZOLE 1 g/100g N 20181231 37205-762_e75e380f-2d17-4757-8305-871c58e314ae 37205-762 HUMAN OTC DRUG leader lubricant eye Polyethylene glycol, Propylene glycol SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130510 OTC MONOGRAPH FINAL part349 Cardinal Health POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL N 20181231 37205-763_2b95a2bf-8a01-4763-95ee-b009e49421ce 37205-763 HUMAN OTC DRUG Leader Lubricating plus carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20130510 OTC MONOGRAPH FINAL part349 Cardinal Health CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL N 20181231 37205-779_21b545c2-b217-4aa9-9aa5-525492a32f35 37205-779 HUMAN OTC DRUG Leader Nite Time Cold Flu Relief Multi Symptom acetaminophen, dextromethorphan hydrobromide, doxylamine succinate LIQUID ORAL 20060620 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 37205-819_7c761d3b-3499-44f9-902e-5768606f547f 37205-819 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20130303 NDA NDA022429 Cardinal Health (Leader) 37205 CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 37205-820_c69e021b-e6d3-4e71-9208-0d981b58e724 37205-820 HUMAN OTC DRUG LEADER ALL DAY ALLERGY cetirizine TABLET ORAL 20071227 ANDA ANDA077498 Cardinal Health CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 37205-822_a78800b9-81d7-46fd-b8ab-c40a6b914779 37205-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20120515 OTC MONOGRAPH FINAL part347 Cardinal Health WITCH HAZEL .86 mL/100L N 20181231 37205-824_8cd0ac0f-0d61-4f83-81bb-17cd5ef05b88 37205-824 HUMAN OTC DRUG Pain Relieving MENTHOL GEL TOPICAL 20120118 OTC MONOGRAPH NOT FINAL part348 Cardinal Health MENTHOL 35 mg/mL N 20181231 37205-826_62e795b9-af6c-4847-a0de-3e4d29e67c90 37205-826 HUMAN OTC DRUG Childrens All Day Allergy (Leader) cetirizine hydrochloride LIQUID ORAL 20090929 ANDA ANDA090254 Cardinal Health CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 37205-827_feb9da06-3aab-4242-aba5-42ff2d989769 37205-827 HUMAN OTC DRUG Leader Allergy D 12 Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080514 ANDA ANDA077170 Cardinal Health CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 37205-831_d03d25c1-1ed0-406e-8ed1-9ce9f87e2ada 37205-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL 19890621 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MINERAL OIL 1 mL/100L N 20181231 37205-833_ff626a58-b210-4744-930b-a6f486515e27 37205-833 HUMAN OTC DRUG Leader Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 19921201 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 37205-834_81d36c5c-f3d9-4196-87d3-13d7425f36e0 37205-834 HUMAN OTC DRUG leader milk of magnesia saline laxative Magnesium hydroxide SUSPENSION ORAL 19971021 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 37205-837_93bfe7e9-0b62-4723-9534-62d6b692a964 37205-837 HUMAN OTC DRUG leader omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080228 NDA NDA022032 Cardinal Health OMEPRAZOLE 20 mg/1 N 20181231 37205-848_1f6782bf-1393-488d-9ed5-51856cab69e8 37205-848 HUMAN OTC DRUG leader ibuprofen Ibuprofen SUSPENSION ORAL 20081016 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL N 20181231 37205-852_ce54a65b-2913-450f-b7af-b23c54fbb742 37205-852 HUMAN OTC DRUG Leader ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 19901115 ANDA ANDA076359 Cardinal Health IBUPROFEN 100 mg/1 N 20181231 37205-854_61a2ea91-ecab-4e05-b535-890d012086a9 37205-854 HUMAN OTC DRUG Leader Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101201 NDA NDA021920 Cardinal Health NAPROXEN SODIUM 220 mg/1 N 20181231 37205-855_4100a2f2-a9bc-4b31-bb1a-052b20a9960d 37205-855 HUMAN OTC DRUG leader childrens all day allergy cetirizine Hydrochloride SOLUTION ORAL 20101109 ANDA ANDA090254 Cardinal Health CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 37205-856_148f2e69-f860-49e4-85ea-c796ca840ba1 37205-856 HUMAN OTC DRUG leader nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120725 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 37205-861_beb12f2b-4165-473c-bcea-adeeb6c96a31 37205-861 HUMAN OTC DRUG Leader Acid Reducer Maximum Strength Famotidine TABLET ORAL 20061102 ANDA ANDA077351 Cardinal Health FAMOTIDINE 20 mg/1 N 20181231 37205-871_424dab4c-f1da-407f-925f-b33cdc23df4a 37205-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LOTION TOPICAL 20120512 OTC MONOGRAPH NOT FINAL part333A Cardinal Health HYDROGEN PEROXIDE 3 kg/100L N 20181231 37205-874_d03c3837-4d31-4ef2-9cf8-4cf6456544ee 37205-874 HUMAN OTC DRUG LEADER Chest Congestion Relief PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 37205-931_bcc8a46c-ba10-4e08-a7ed-d06b4f016847 37205-931 HUMAN OTC DRUG Leader Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20061030 OTC MONOGRAPH FINAL part341 Cardinal Health PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 2.5; 1 mg/5mL; mg/5mL N 20181231 37205-940_0e17ede8-3ea8-4897-8b4b-3bc0a9247b05 37205-940 HUMAN OTC DRUG leader allergy multi symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20060118 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 37205-941_f129e1a4-b206-416e-8469-9bc2b11f9ec3 37205-941 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Cardinal Health TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 37205-967_cedcc676-4708-4a36-8d77-d2b9ab951c75 37205-967 HUMAN OTC DRUG Leader Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070104 ANDA ANDA076777 Cardinal Health NICOTINE 2 mg/1 N 20181231 37205-968_e4e36b54-6bb9-417f-865a-e5646f8486e5 37205-968 HUMAN OTC DRUG Leader Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070104 ANDA ANDA076779 Cardinal Health NICOTINE 4 mg/1 N 20181231 37205-969_163d504f-f028-4b47-ae96-a3cb34af288e 37205-969 HUMAN OTC DRUG Leader Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20070426 OTC MONOGRAPH FINAL part343 Cardinal Health BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 37205-970_242dc915-ecdd-4483-a1a8-5fb143486fc9 37205-970 HUMAN OTC DRUG leader tussin dm Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 19911021 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 37205-973_2c541b4c-22b3-4960-8b76-03c2cc6fc490 37205-973 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070320 OTC MONOGRAPH NOT FINAL part333A Cardinal Health BENZALKONIUM CHLORIDE .13 mL/mL E 20171231 37205-976_5c2ebac8-c6fe-4ce2-8235-f118d483dc36 37205-976 HUMAN OTC DRUG Ethyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL .7 L/100L N 20181231 37205-977_dbd69e60-8b0f-47ec-a1bf-0ba4f72cb74b 37205-977 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120512 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL .7 L/100L N 20181231 37205-980_80df59b0-86a6-4493-aec4-f418223a5c3c 37205-980 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20040510 20200831 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ACETAMINOPHEN 500 mg/1 N 20181231 37205-987_ac05310d-5e15-4067-95ab-c6917cd2d971 37205-987 HUMAN OTC DRUG leader nicotine Nicotine Polacrilex LOZENGE ORAL 20071005 ANDA ANDA077007 Cardinal Health NICOTINE 2 mg/1 N 20181231 37205-988_bd8b1ef3-f084-46c3-a45d-0933c24df43d 37205-988 HUMAN OTC DRUG leader nicotine Nicotine Polacrilex LOZENGE ORAL 20071005 ANDA ANDA077007 Cardinal Health NICOTINE 4 mg/1 N 20181231 37205-989_208929dd-eab8-47fd-93f8-9ff512c87f15 37205-989 HUMAN OTC DRUG Alcohol Swab with Benzocaine benzocaine SWAB TOPICAL 20070701 OTC MONOGRAPH NOT FINAL part348 Cardinal Health BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 E 20171231 37205-993_9fe44af7-25fa-4272-b676-fb1ee749363b 37205-993 HUMAN OTC DRUG Leader Childrens Mucus Relief Cough Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20071011 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 37205-998_764c15e2-1f06-4d3c-a177-8d26e86ae7ad 37205-998 HUMAN OTC DRUG Leader Medicated Miconazole nitrate AEROSOL, SPRAY TOPICAL 20100315 OTC MONOGRAPH FINAL part333C Cardinal Health Inc. MICONAZOLE NITRATE 2.6 g/130g N 20181231 37808-001_ea34841f-c541-44fe-bd7b-e4687a294922 37808-001 HUMAN OTC DRUG Anti Nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19951122 UNAPPROVED DRUG OTHER H E B DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 37808-003_e9c23f3e-f090-4c0d-95fb-1426bcf6464f 37808-003 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130601 OTC MONOGRAPH NOT FINAL part356 H E B EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37808-004_b03dc83e-9b09-4955-95e1-50d32aba2228 37808-004 HUMAN OTC DRUG nasal oxymetazoline hydrochloride SPRAY NASAL 20141202 OTC MONOGRAPH FINAL part341 H E B OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 37808-005_55fa94cb-7e1c-41bc-879a-5618a828f14a 37808-005 HUMAN OTC DRUG antibiotic Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20150914 OTC MONOGRAPH FINAL part333B H E B NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g N 20181231 37808-006_f4725f28-7f42-e340-b76e-a76c91b1b339 37808-006 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20160101 ANDA ANDA078878 HEB OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 37808-009_1afb6577-8c03-477b-9c16-a7c8aac30d76 37808-009 HUMAN OTC DRUG Healing petrolatum OINTMENT TOPICAL 20110415 OTC MONOGRAPH FINAL part347 H E B PETROLATUM 340 mg/g N 20181231 37808-011_9c97e809-a16b-4a6e-b0a1-3f51a2cfc8f9 37808-011 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part348 HEB MENTHOL 1.5 mg/g N 20181231 37808-012_f5631185-b1e7-430c-a8b8-92be8b3ec174 37808-012 HUMAN OTC DRUG Allergy Childrens Diphenhydramine Hydrochloride LIQUID ORAL 20160229 OTC MONOGRAPH FINAL part341 H E B DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 37808-015_b463e36f-c2f8-4b0c-ae49-6e1bcef247e1 37808-015 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20100729 OTC MONOGRAPH FINAL part347 H E B PETROLATUM 1 g/g N 20181231 37808-016_a0542443-9008-441b-8082-2589ed483511 37808-016 HUMAN OTC DRUG Flu Relief Therapy Daytime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20160131 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 37808-017_02d681c3-0417-4ed8-8f66-b624d29fe204 37808-017 HUMAN OTC DRUG Severe Cold and Cough Relief Nighttime Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20151031 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 37808-018_74e2be9b-36d0-4683-a69e-40cbffff335d 37808-018 HUMAN OTC DRUG Senna laxative Sennosides TABLET ORAL 20141130 OTC MONOGRAPH NOT FINAL part334 H E B SENNOSIDES 8.6 mg/1 N 20181231 37808-020_d66b86e6-7b83-4d84-9d52-b7ff0ccc232c 37808-020 HUMAN OTC DRUG Diaper Rash Zinc oxide PASTE TOPICAL 20100910 OTC MONOGRAPH FINAL part347 H E B ZINC OXIDE 532 mg/g N 20181231 37808-021_26e17c94-23ac-4c29-a2b8-4dca08cd3fb9 37808-021 HUMAN OTC DRUG nasal oxymetazoline hydrochloride SPRAY NASAL 20150203 OTC MONOGRAPH FINAL part341 H E B OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 37808-022_8c74b0a5-6bbc-0f8d-bbda-46d6cb39aea6 37808-022 HUMAN OTC DRUG Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE ORAL 20151221 ANDA ANDA076667 HEB FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 N 20181231 37808-023_a76cedd6-5053-44e5-89a8-44820d69566e 37808-023 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION ORAL 20160301 ANDA ANDA074937 H E B IBUPROFEN 100 mg/5mL N 20181231 37808-025_5146946d-b52d-4fe3-89e2-8c7875fea456 37808-025 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH FINAL part338 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37808-029_c3f8de40-f379-46bf-b288-008cc71466c0 37808-029 HUMAN OTC DRUG In control nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050606 ANDA ANDA076775 H E B NICOTINE 2 mg/1 N 20181231 37808-032_39a761e3-a62a-1220-e054-00144ff88e88 37808-032 HUMAN OTC DRUG Menthol Cough Drop menthol LOZENGE ORAL 20130515 OTC MONOGRAPH FINAL part341 HEB MENTHOL 5.4 mg/1 N 20181231 37808-032_39a9be53-f73d-727a-e054-00144ff8d46c 37808-032 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20130515 OTC MONOGRAPH FINAL part341 HEB MENTHOL 5.4 mg/1 N 20181231 37808-033_39bd0ca1-3490-0ce1-e054-00144ff88e88 37808-033 HUMAN OTC DRUG Cherry cough drop Menthol LOZENGE ORAL 20130515 OTC MONOGRAPH FINAL part341 HEB MENTHOL 5.8 mg/1 N 20181231 37808-033_39e2c90e-56b6-1f0a-e054-00144ff8d46c 37808-033 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20130515 OTC MONOGRAPH FINAL part341 HEB MENTHOL 5.8 mg/1 N 20181231 37808-034_39e4c956-02e4-049e-e054-00144ff8d46c 37808-034 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20130515 OTC MONOGRAPH FINAL part341 HEB MENTHOL 7.5 1/1 N 20181231 37808-035_3a205e97-2fe4-577a-e054-00144ff8d46c 37808-035 HUMAN OTC DRUG Strawberry Cough Drop Menthol LOZENGE ORAL 20131125 OTC MONOGRAPH FINAL part341 HEB MENTHOL 2.7 mg/1 N 20181231 37808-036_12e7f0e2-4007-440f-a8b0-72948909f887 37808-036 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20140409 ANDA ANDA090283 HEB FAMOTIDINE 20 mg/1 N 20181231 37808-037_3b4cdf48-1eae-01c5-e054-00144ff8d46c 37808-037 HUMAN OTC DRUG Wild Berry Throat Drop Pectin LOZENGE ORAL 20120626 OTC MONOGRAPH NOT FINAL part356 HEB PECTIN 7 mg/1 N 20181231 37808-038_227de322-e94b-4656-b56e-c32e6f1b76b8 37808-038 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 H E B DOCUSATE SODIUM 100 mg/1 N 20181231 37808-040_5d5784eb-0568-1e49-e053-2a91aa0ad53b 37808-040 HUMAN OTC DRUG HEB Calaclear Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 H E B ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 37808-042_cbe72270-b172-4662-9b9b-557e8cf53ffe 37808-042 HUMAN OTC DRUG Acid Controller Famotidine TABLET ORAL 20160914 ANDA ANDA077351 H E B FAMOTIDINE 20 mg/1 N 20181231 37808-050_f341b4ca-dae3-4a0d-b64d-10f29528be48 37808-050 HUMAN OTC DRUG rx act ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090311 ANDA ANDA079113 H E B DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 37808-051_3a443179-b7a7-3242-e054-00144ff8d46c 37808-051 HUMAN OTC DRUG SF Menthol Cough Drop Menthol LOZENGE ORAL 20120629 OTC MONOGRAPH FINAL part341 HEB MENTHOL 5.8 mg/1 N 20181231 37808-052_3a467fc6-6cf2-34c1-e054-00144ff8d46c 37808-052 HUMAN OTC DRUG SF Cherry Cough Drop Menthol LOZENGE ORAL 20120629 OTC MONOGRAPH FINAL part341 HEB MENTHOL 5.8 mg/1 N 20181231 37808-053_3a6f0d1b-6b5c-19ac-e054-00144ff8d46c 37808-053 HUMAN OTC DRUG SF Honey Lemon Cough Drop Menthol LOZENGE ORAL 20120629 OTC MONOGRAPH FINAL part341 HEB MENTHOL 7.6 mg/1 N 20181231 37808-053_3a70acf9-848e-20ca-e054-00144ff88e88 37808-053 HUMAN OTC DRUG SF Honey Lemon Cough Drop Menthol LOZENGE ORAL 20120702 OTC MONOGRAPH FINAL part341 HEB MENTHOL 7.6 mg/1 N 20181231 37808-053_3a71e885-fadd-44ad-e054-00144ff8d46c 37808-053 HUMAN OTC DRUG SF Honey Lemon Cough Drop Menthol LOZENGE ORAL 20150921 OTC MONOGRAPH FINAL part341 HEB MENTHOL 7.6 mg/1 N 20181231 37808-055_330b74b1-4cbb-43f3-b9fc-eb26213094e1 37808-055 HUMAN OTC DRUG Isopropyl ISOPROPYL ALCOHOL SOLUTION TOPICAL 20150313 OTC MONOGRAPH NOT FINAL part333A H-E-B ISOPROPYL ALCOHOL 462 mg/mL N 20181231 37808-056_82f2a08e-b136-4646-bc60-648ed4c5aa3e 37808-056 HUMAN OTC DRUG night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140414 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 37808-057_821ac63a-8f00-4949-ab47-843723bb41e4 37808-057 HUMAN OTC DRUG ibuprofen infants ibuprofen SUSPENSION ORAL 20020618 ANDA ANDA075217 H E B IBUPROFEN 50 mg/1.25mL N 20181231 37808-058_3b4e6ac5-4d9c-3e84-e054-00144ff88e88 37808-058 HUMAN OTC DRUG Cherry Antacid Soft Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20120419 OTC MONOGRAPH FINAL part331 HEB CALCIUM CARBONATE 1177 mg/1 N 20181231 37808-059_3b756c58-f457-63a3-e054-00144ff8d46c 37808-059 HUMAN OTC DRUG Assorted Fruit Panned Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20150623 OTC MONOGRAPH FINAL part331 HEB CALCIUM CARBONATE 750 mg/1 N 20181231 37808-060_3a30a427-6ab5-24ae-e054-00144ff88e88 37808-060 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20130515 OTC MONOGRAPH FINAL part341 HEB MENTHOL 7.5 mg/1 N 20181231 37808-060_3a325c56-4a2e-1bfe-e054-00144ff8d46c 37808-060 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20130515 OTC MONOGRAPH FINAL part341 HEB MENTHOL 7.5 mg/1 N 20181231 37808-060_3a3468b4-0628-71cd-e054-00144ff8d46c 37808-060 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20130515 OTC MONOGRAPH FINAL part341 HEB MENTHOL 7.5 mg/1 N 20181231 37808-062_3063ea93-6bc3-1d18-e054-00144ff88e88 37808-062 HUMAN OTC DRUG Mixed Berry Sore Throat and Cough Lozenges Benzocaine LOZENGE ORAL 20160413 OTC MONOGRAPH NOT FINAL part356 HEB BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20181231 37808-063_3b8b1924-3b34-0420-e054-00144ff8d46c 37808-063 HUMAN OTC DRUG Assorted Fruit Panned Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20150623 OTC MONOGRAPH FINAL part331 HEB CALCIUM CARBONATE 750 mg/1 N 20181231 37808-063_3be8662a-c7b8-4d9c-e054-00144ff88e88 37808-063 HUMAN OTC DRUG Assorted Fruit panned chew Calcium Carbonate TABLET, CHEWABLE ORAL 20160710 OTC MONOGRAPH FINAL part331 HEB CALCIUM CARBONATE 750 mg/1 N 20181231 37808-065_47bf3464-14dc-4bcc-b149-5ce21c65d298 37808-065 HUMAN OTC DRUG rx act nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 19951012 OTC MONOGRAPH FINAL part341 H E B OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 37808-066_6e406280-eafc-4f10-9426-f6f8b0783889 37808-066 HUMAN OTC DRUG ORCHID JASMINE TEA AND BASIL ETHYL ALCOHOL LIQUID TOPICAL 20140317 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 620 mg/mL N 20181231 37808-066_dd1e6c21-6194-44a2-b292-e00e7477e5f2 37808-066 HUMAN OTC DRUG ORCHID JASMINE TEA AND BASIL ETHYL ALCOHOL LIQUID TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 620 mg/mL N 20181231 37808-068_19d5cb6d-35d9-4527-a84a-6e4f88488899 37808-068 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20150930 ANDA ANDA079096 H E B NAPROXEN SODIUM 220 mg/1 N 20181231 37808-069_71d8ae83-fe41-466f-bb3c-a048179f2b49 37808-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20090803 OTC MONOGRAPH FINAL part347 H E B PETROLATUM 1 g/g N 20181231 37808-070_a2f00229-1e86-491d-a5f2-d6e1242cd1fc 37808-070 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20161021 OTC MONOGRAPH FINAL part358H HEB PYRITHIONE ZINC 10 mg/mL N 20181231 37808-071_31f72336-d751-4367-93a9-a50a66cc5823 37808-071 HUMAN OTC DRUG ORCHID BY H E B ANTIBACTERIAL MOISTURIZING VANILLA AND APPLE BLOSSOM TRICLOSAN LIQUID TOPICAL 20150118 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN 3 mg/mL N 20181231 37808-072_cd66762d-c8f3-4c6e-8c1b-6eea68d39d4f 37808-072 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19950425 OTC MONOGRAPH NOT FINAL part356 H-E-B EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37808-075_56a117c4-ba84-4d57-958d-aa5505878767 37808-075 HUMAN OTC DRUG Nasoflow Fluticasone propionate SPRAY, METERED NASAL 20160530 ANDA ANDA207957 H E B FLUTICASONE PROPIONATE 50 ug/1 N 20181231 37808-077_14dd4e12-c66d-348a-e054-00144ff8d46c 37808-077 HUMAN OTC DRUG Mucus Relief Day Time and Night Time Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20150401 OTC MONOGRAPH FINAL part341 HEB N 20181231 37808-079_14dd4e12-c686-348a-e054-00144ff8d46c 37808-079 HUMAN OTC DRUG Mucus Relief Severe Cold ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20150401 OTC MONOGRAPH FINAL part341 HEB ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 37808-080_5587d694-5cb6-4125-84bc-008b7058471b 37808-080 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 H E B TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 37808-081_09a79382-805e-42e1-8ee8-a24b1212eb03 37808-081 HUMAN OTC DRUG ORCHID BY H E B ANTIBACTERIAL HAND WHITE LAVENDER AND MINT TRICLOSAN LIQUID TOPICAL 20141218 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN 3 mg/mL N 20181231 37808-082_90124ce6-7802-42f6-b733-0d1d3fc5446e 37808-082 HUMAN OTC DRUG ORCHID BY H E B CACTUS FLOWER AND MANGO ANTIBACTERIAL GENTLE FOAMING HAND TRICLOSAN LIQUID TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN 3 mg/mL N 20181231 37808-084_7d16ab1f-49b4-4f29-9cd0-bee5d2b36662 37808-084 HUMAN OTC DRUG Stool Softener plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20160430 OTC MONOGRAPH NOT FINAL part334 H E B DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 37808-085_05953fc3-e0c3-4257-a0cd-cc89ca69fc3c 37808-085 HUMAN OTC DRUG Allergy Relief Childrens Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 H E B LORATADINE 5 mg/5mL N 20181231 37808-090_b9484a9c-e288-4fac-ac77-cc9a6b3fc829 37808-090 HUMAN OTC DRUG ORCHID JASMINE TEA AND BASIL TRICLOSAN LIQUID TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part333E H.E.B. TRICLOSAN 3 mg/mL N 20181231 37808-091_c7a44eda-3cd9-454f-9174-462366c14a46 37808-091 HUMAN OTC DRUG ORCHID CACTUS FLOWER AND MANGO TRICLOSAN LIQUID TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part333E H.E.B. TRICLOSAN 3 mg/mL N 20181231 37808-092_ab180244-bd0b-486e-a359-88080e43ecf9 37808-092 HUMAN OTC DRUG Allergy Relief Childrens Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 H E B LORATADINE 5 mg/5mL N 20181231 37808-097_19edb3a9-214d-498a-8f5b-04ba4e045095 37808-097 HUMAN OTC DRUG ORCHID BY H E B WHITE LAVENDER AND MINT TRICLOSAN LIQUID TOPICAL 20140424 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN 3 mg/mL N 20181231 37808-098_5d574039-bf41-c9de-e053-2a91aa0a2075 37808-098 HUMAN OTC DRUG HEB Water Drying Aid Isopropyl Alcohol LIQUID AURICULAR (OTIC) 20080101 OTC MONOGRAPH FINAL part344 H E B ISOPROPYL ALCOHOL 950 mg/mL N 20181231 37808-102_4d7be6f8-972e-40cc-a23d-6bdce28b47af 37808-102 HUMAN OTC DRUG HEB Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 H E B CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 37808-104_92ce6a93-94ea-42cb-9b3c-330423605e2f 37808-104 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20141231 OTC MONOGRAPH FINAL part338 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37808-105_5d576794-88c1-484a-e053-2991aa0aa479 37808-105 HUMAN OTC DRUG HEB Camphor Phenol Camphor 10.8% and Phenol 4.7% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 H E B CAMPHOR (NATURAL); PHENOL 108; 47 mg/mL; mg/mL N 20181231 37808-106_f3634dbc-c373-4eef-b6b6-acced4f35648 37808-106 HUMAN OTC DRUG Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 H E B CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 37808-107_5c8ffeb0-67a2-46b8-9217-483fb7a67183 37808-107 HUMAN OTC DRUG ORCHID BY H E B VANILLA BROWN SUGAR TRICLOSAN LIQUID TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN 4.6 mg/mL N 20181231 37808-109_5c380700-45fb-12c1-e053-2991aa0af3d5 37808-109 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20101201 ANDA ANDA079174 HEB IBUPROFEN 200 mg/1 N 20181231 37808-112_0cbc8bc5-6989-4d70-906a-133a10f8e8ea 37808-112 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19810825 OTC MONOGRAPH FINAL part341 H E B PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20191231 37808-117_e9cf7851-10d6-45a0-9a09-88163b1c848b 37808-117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 H E B LANSOPRAZOLE 15 mg/1 N 20181231 37808-121_ea712fc4-7f27-4556-b1b8-028f3f6ce57a 37808-121 HUMAN OTC DRUG Dual Action Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20160407 ANDA ANDA077355 H E B FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 37808-122_2f2d567e-4906-bd22-18e3-de69b47882d5 37808-122 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20160720 ANDA ANDA074612 H-E-B NICOTINE 14 mg/24h N 20191231 37808-123_2f2d567e-4906-bd22-18e3-de69b47882d5 37808-123 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20160720 ANDA ANDA074612 H-E-B NICOTINE 21 mg/24h N 20191231 37808-124_050cca35-326e-42f5-8b07-88da13228d3e 37808-124 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20100215 ANDA ANDA090711 H E B NICOTINE 2 mg/1 N 20181231 37808-130_0df991e7-66ea-4737-b6c4-dd570b0a6d87 37808-130 HUMAN OTC DRUG pain relief Acetaminophen SUSPENSION ORAL 19960429 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/5mL N 20181231 37808-141_935d295c-6876-434d-b8d6-674a1207bf0b 37808-141 HUMAN OTC DRUG heartburn prevention acid reducer Famotidine TABLET ORAL 20090911 ANDA ANDA075400 H E B FAMOTIDINE 10 mg/1 N 20181231 37808-144_ae946411-5c1b-4f43-b075-6e9578b7fd7f 37808-144 HUMAN OTC DRUG Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 19920618 OTC MONOGRAPH FINAL part331 H E B ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 37808-146_36f1bf50-56c9-43d3-a71d-1c47c9215688 37808-146 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20140606 ANDA ANDA090821 H E B NICOTINE 2 mg/1 N 20181231 37808-153_6337909e-abb6-4c80-a2f0-932cf79bba87 37808-153 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20160926 OTC MONOGRAPH FINAL part358H HEB PYRITHIONE ZINC 1 mg/mL N 20181231 37808-157_537d9459-e6d0-4bfb-a514-59c3bd6e0204 37808-157 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 H E B ASPIRIN 325 mg/1 N 20181231 37808-158_8e46fe47-e429-4b0c-ae4a-9b8e5e6a5036 37808-158 HUMAN OTC DRUG Congestion Relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20160418 ANDA ANDA203200 H E B IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20181231 37808-160_e62b741c-1c1f-4bac-809a-3c315c12c276 37808-160 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20121111 OTC MONOGRAPH FINAL part346 H E B COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g N 20181231 37808-161_7e46b477-c853-46ba-9172-fa701fa82df0 37808-161 HUMAN OTC DRUG Pain and Fever Acetaminophen SUSPENSION ORAL 20111215 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/5mL N 20181231 37808-163_909a45a2-6a6b-4846-a84c-4f234059af6e 37808-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20100929 OTC MONOGRAPH FINAL part355 HEB SODIUM FLUORIDE 1 mg/mL N 20181231 37808-164_14dd4e12-c62a-348a-e054-00144ff8d46c 37808-164 HUMAN OTC DRUG Mucus Relief Cold, Flu and Sore Throat ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20150401 OTC MONOGRAPH FINAL part341 HEB ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 37808-165_24273bb8-9f20-4002-8094-a5640daa0650 37808-165 HUMAN OTC DRUG ORCHID ANTIBACTERIAL VANILLA AND APPLE BLOSSOM ETHYL ALCOHOL LIQUID TOPICAL 20141117 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 620 mg/mL N 20181231 37808-165_3d6b189d-d808-4812-8e98-f007760710e4 37808-165 HUMAN OTC DRUG ORCHID ANTIBACTERIAL VANILLA AND APPLE BLOSSOM ETHYL ALCOHOL LIQUID TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 620 mg/mL N 20181231 37808-167_9338b577-c3b2-4f2e-b9c1-67d3494b6c7c 37808-167 HUMAN OTC DRUG HEB HEBuddy Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 HEB SODIUM FLUORIDE .243 g/100g N 20181231 37808-168_60f2a0c3-1e62-4521-9851-91616fa8fbb4 37808-168 HUMAN OTC DRUG Hill Country Essentials Antibacterial Foaming Triclosan SOAP TOPICAL 20100722 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .6 mL/100mL N 20181231 37808-168_7e7a8137-a809-4efb-8a06-cf9e00a6956a 37808-168 HUMAN OTC DRUG Hill Country Essentials Antibacterial Foaming Triclosan SOAP TOPICAL 20100722 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .6 mL/100mL N 20181231 37808-169_03ecba75-be3f-4333-bd0d-a407354aec11 37808-169 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110616 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN .46 mL/100mL N 20181231 37808-170_cc6fa022-1da1-4f8e-a1c7-a2d6c455f5d6 37808-170 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050615 ANDA ANDA076789 H E B NICOTINE 4 mg/1 N 20181231 37808-171_7f40fc97-a527-448b-858f-d5052a48160b 37808-171 HUMAN OTC DRUG HEB Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 HEB STANNOUS FLUORIDE .454 g/100g N 20181231 37808-175_e9ea21f0-3f71-4fb9-834f-393b1b3bac51 37808-175 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20150731 NDA NDA021920 H E B NAPROXEN SODIUM 220 mg/1 N 20181231 37808-176_dec0b291-43ed-42b3-8572-a0a22265557a 37808-176 HUMAN OTC DRUG all day Allergy Relief D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080502 ANDA ANDA077170 H E B CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 37808-177_f200d420-8264-41ae-8cf5-b3cfe9b42874 37808-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110909 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN .46 mL/100mL N 20181231 37808-177_f2634a39-c687-422e-a4c9-a46c88718665 37808-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111102 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN .46 mL/100mL N 20181231 37808-178_34ddf662-3441-372a-e054-00144ff88e88 37808-178 HUMAN OTC DRUG Daytime Severe Cold and Flu Maximum Strength ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20160501 OTC MONOGRAPH FINAL part341 HEB ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 37808-180_295d4618-3c73-45e0-b0ec-46302db61d1b 37808-180 HUMAN OTC DRUG Senna Laxative Natural Vegetable Laxative SENNOSIDES TABLET ORAL 20100729 OTC MONOGRAPH NOT FINAL part334 H E B SENNOSIDES 8.6 mg/1 N 20181231 37808-181_789d7ac6-ff4b-4952-af3b-e194ec9ded81 37808-181 HUMAN OTC DRUG WHITE LAVENDAR AND MINT ANTIBACTERIAL GENTLE FOAMING HAND SP TRICLOSAN LIQUID TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .3 mL/100mL N 20181231 37808-182_9f8b86c2-66bc-4b90-8add-2a4b7fe266aa 37808-182 HUMAN OTC DRUG CACTUS FLOWER AND MANGO ANTIBACTERIAL GENTLE FOAMING HAND SP TRICLOSAN LIQUID TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .3 mL/100mL N 20181231 37808-186_1700c398-a877-4af7-8672-f955f733094f 37808-186 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl SOLUTION ORAL 20131030 OTC MONOGRAPH FINAL part338 H E B DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 37808-188_169ac371-c3da-44f8-8b8d-072c39654a93 37808-188 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140420 OTC MONOGRAPH FINAL part346 H E B MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 37808-190_88f87810-9e1c-4087-906a-b6d8d26dc20a 37808-190 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20100215 ANDA ANDA090711 H E B NICOTINE 4 mg/1 N 20181231 37808-192_297c8aba-098c-4147-a984-f05b11c6354f 37808-192 HUMAN OTC DRUG HEB HEBuddy Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 HEB SODIUM FLUORIDE .243 g/100g N 20181231 37808-195_438bf1fe-0129-4be1-a4ab-60b321a451d2 37808-195 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 500 mg/1 N 20181231 37808-198_6037544d-421a-494f-8185-417ecbecbbdc 37808-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130108 ANDA ANDA078682 H E B IBUPROFEN 200 mg/1 N 20181231 37808-199_b898bbc5-d953-4386-8931-f969a2b13e20 37808-199 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100607 ANDA ANDA079114 H E B N 20181231 37808-200_32ead44f-0881-416e-b27d-346f502d15f7 37808-200 HUMAN OTC DRUG childrens ibuprofen Ibuprofen SUSPENSION ORAL 20020619 ANDA ANDA074937 H E B IBUPROFEN 100 mg/5mL N 20181231 37808-201_34054115-a72e-4476-b17c-e93f4c2e4f6f 37808-201 HUMAN OTC DRUG ORCHID BY H E B VANILLA BROWN SUGAR ETHYL ALCOHOL LIQUID TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 650 mg/mL N 20181231 37808-202_38fc924b-be38-4746-9969-de836d1b1297 37808-202 HUMAN OTC DRUG Minoxidil minoxidil SOLUTION TOPICAL 20110404 ANDA ANDA075357 H E B MINOXIDIL 2 g/100mL N 20181231 37808-204_c3f938d3-316f-4596-9dc3-187a20a7979b 37808-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 HEB PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 37808-205_8416eb8f-e7fc-4cae-9aa1-84b2321ad67e 37808-205 HUMAN OTC DRUG Nasopro 24 Fluticasone propionate SPRAY, METERED NASAL 20160530 ANDA ANDA207957 H E B FLUTICASONE PROPIONATE 50 ug/1 N 20181231 37808-206_d2e7caac-10d9-496b-a478-238858e81fa7 37808-206 HUMAN OTC DRUG In Control Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050615 ANDA ANDA078325 H E B NICOTINE 2 mg/1 N 20181231 37808-208_cfe60090-ff71-40dc-9eca-2a2a8e7865ae 37808-208 HUMAN OTC DRUG H-E-B Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 H E B CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 37808-209_76cef1e3-4beb-44cc-98aa-af503051beff 37808-209 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20160926 OTC MONOGRAPH FINAL part341 H E B PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 37808-210_e7868625-4ca0-434e-8a29-fcc1a4519445 37808-210 HUMAN OTC DRUG Advanced Antiseptic Citrus EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 20101015 OTC MONOGRAPH NOT FINAL part356 H E B EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .042 mL/100L; mL/100L; mL/100L; mL/100L N 20181231 37808-211_62a2eab6-690e-4c04-974c-2ecd79c3ae24 37808-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20131009 NDA NDA022429 H E B CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 37808-213_ab088eb2-b600-449e-a1c2-86d7ea3e600d 37808-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20160621 OTC MONOGRAPH FINAL part355 HEB SODIUM FLUORIDE .2 mg/mL N 20181231 37808-215_cc958100-a918-46f9-9f70-20617a889a40 37808-215 HUMAN OTC DRUG HILL COUNTRY ESSENTIALS TRICLOSAN LIQUID TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333E H.E.B. TRICLOSAN 1.5 mg/mL N 20181231 37808-219_3dcc0017-8d68-4d02-93b7-3eb34ac0ad44 37808-219 HUMAN OTC DRUG Blackhead Clearing Scrub Salicylic acid GEL TOPICAL 20090623 OTC MONOGRAPH FINAL part333D H E B SALICYLIC ACID 19.4 mg/g N 20181231 37808-220_9ad63cc4-b300-4634-a34d-b1fab1aa30d8 37808-220 HUMAN OTC DRUG Hill Country Essentials Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .15 mL/100mL N 20181231 37808-220_cc740934-d7ed-4c22-8fba-e989f9efa142 37808-220 HUMAN OTC DRUG Hill Country Essentials Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .15 mL/100mL N 20181231 37808-225_0faef1c4-1af2-4b9b-a44d-8d2914a4392f 37808-225 HUMAN OTC DRUG HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100705 OTC MONOGRAPH NOT FINAL part333 HEB ALCOHOL 62 mL/100mL N 20181231 37808-230_1ec2c62a-f2c2-44b9-ad56-95c2cf47d28d 37808-230 HUMAN OTC DRUG H E B Restore and Defend Fluoride PASTE, DENTIFRICE DENTAL 20140701 OTC MONOGRAPH FINAL part355 HEB STANNOUS FLUORIDE .15 g/100g N 20181231 37808-232_5d578e5e-ad72-2ebe-e053-2a91aa0aa0e3 37808-232 HUMAN OTC DRUG HEB Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A H E B POVIDONE-IODINE 100 mg/mL N 20181231 37808-235_cbd9e5c4-e22d-4bbc-8bee-60af7e7980c3 37808-235 HUMAN OTC DRUG ANTIBACTERIAL SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20110808 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 62 mL/100mL N 20181231 37808-236_270ec7ac-8632-4d22-a7fc-910908b695d7 37808-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140530 OTC MONOGRAPH FINAL part338 H E B DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 37808-238_fb4d941d-3af3-4898-a3de-cf75e7e06b02 37808-238 HUMAN OTC DRUG HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110203 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 62 mL/100mL N 20181231 37808-239_eb1dccb7-b4d4-4613-8bd7-e2df542220ab 37808-239 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 H E B DOCUSATE SODIUM 100 mg/1 N 20181231 37808-240_f93fa0b3-7551-443b-981d-d3dd5cbefed5 37808-240 HUMAN OTC DRUG FOAMING HAND SANITIZER WITH ALOE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333 HEB BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 37808-242_dd5394c9-8138-49ca-bc84-07f653dcae0c 37808-242 HUMAN OTC DRUG miconazole 3 Miconazole nitrate KIT 20060314 ANDA ANDA075329 H E B N 20181231 37808-244_ab7556fb-4a18-4487-a34d-32a765e44707 37808-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140328 OTC MONOGRAPH NOT FINAL part334 H E B DOCUSATE SODIUM 100 mg/1 N 20181231 37808-245_7835aaef-4285-40d3-80a4-cab566b0bc1f 37808-245 HUMAN OTC DRUG Laxative Pills Sennosides TABLET ORAL 20141031 OTC MONOGRAPH NOT FINAL part334 H E B SENNOSIDES 25 mg/1 N 20181231 37808-246_59a3e92a-58aa-0951-e053-2991aa0a516b 37808-246 HUMAN OTC DRUG Aspirin 81 mg Low Dose ASPIRIN TABLET, DELAYED RELEASE ORAL 20100401 OTC MONOGRAPH NOT FINAL part343 HEB ASPIRIN 81 mg/1 N 20181231 37808-248_a3fc7c17-f521-4688-8ed8-d69414f9f0b2 37808-248 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090123 OTC MONOGRAPH FINAL part341 H E B CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg N 20181231 37808-252_02577a01-2e24-41af-bc83-0e09b3e2cc18 37808-252 HUMAN OTC DRUG Sleep Aid Nighttime diphenhydramine hydrochloride TABLET ORAL 20140831 OTC MONOGRAPH FINAL part338 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37808-253_a674048f-b46f-44ab-90b3-9a0ec99c276a 37808-253 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100202 OTC MONOGRAPH NOT FINAL part333 HEB ALCOHOL 65 mL/100mL N 20181231 37808-254_ada0a890-6761-44c5-aa03-ed4eec1f4cdb 37808-254 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE ETHYL ALCOHOL GEL TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 65 mL/100mL N 20181231 37808-255_ceb08cdd-293b-4a98-8a7d-afbe1f6fab62 37808-255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20050225 ANDA ANDA075217 H E B IBUPROFEN 50 mg/1.25mL N 20181231 37808-258_f51b8cbc-6cfb-432b-ad55-9b978f9147ad 37808-258 HUMAN OTC DRUG Stool Softener Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20160831 OTC MONOGRAPH NOT FINAL part334 H E B DOCUSATE SODIUM 250 mg/1 N 20181231 37808-259_73745306-18b8-4ba1-af73-d28fc3fbbf08 37808-259 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 19970224 ANDA ANDA074661 H E B NAPROXEN SODIUM 220 mg/1 N 20181231 37808-263_9a0f3d1a-3b4a-407e-8702-3cede843b50c 37808-263 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20141014 OTC MONOGRAPH FINAL part333B H E B BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 37808-265_698e3c0d-b760-4ec7-9631-65c2c47fb097 37808-265 HUMAN OTC DRUG VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 62 mL/100mL N 20181231 37808-265_77cc3aa7-aaaf-4185-8f57-ddbbd7941cb1 37808-265 HUMAN OTC DRUG VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 62 mL/100mL N 20181231 37808-266_720daeb3-e84f-4616-9aba-a7ef7cff220a 37808-266 HUMAN OTC DRUG JASMINE TEA AND BASIL ANTIBACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 62 mL/100mL N 20181231 37808-266_da7c4ac0-3656-4a53-bdf9-ac0f26ee97f2 37808-266 HUMAN OTC DRUG JASMINE TEA AND BASIL ANTIBACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 62 mL/100mL N 20181231 37808-267_ff8625dd-b6e3-4f50-a25c-a44f68052679 37808-267 HUMAN OTC DRUG HEB JASMINE TEA AND BASIL ETHYL ALCOHOL LIQUID TOPICAL 20131106 OTC MONOGRAPH NOT FINAL part333E HEB ALCOHOL 620 mg/mL N 20181231 37808-269_14dd4e12-c655-348a-e054-00144ff8d46c 37808-269 HUMAN OTC DRUG Mucus Relief Sinus Day and Night Acetaminophen, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20150401 OTC MONOGRAPH FINAL part341 HEB N 20181231 37808-278_e074e300-b932-4714-b339-4eae2e44697b 37808-278 HUMAN OTC DRUG Benzalkonium chloride Benzalkonium chloride 0.13% SOAP TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333A HEB BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 37808-279_04ba8603-fc9c-4cf7-b6b9-c54202a09cb3 37808-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140930 OTC MONOGRAPH FINAL part346 H E B COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 37808-281_d31776c5-3bc1-46f5-9eec-a46341cc6f74 37808-281 HUMAN OTC DRUG Dry Scalp Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20161026 OTC MONOGRAPH FINAL part358H HEB PYRITHIONE ZINC 10 mg/mL N 20181231 37808-285_fca2f2c0-d9d1-48a7-8d58-f96d6e19c1e0 37808-285 HUMAN OTC DRUG Pain Relief Childrens Dye Free Acetaminophen SUSPENSION ORAL 20170430 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/5mL N 20181231 37808-288_62eeac20-19e3-403f-9d76-088516f32cf3 37808-288 HUMAN OTC DRUG Childrens mucus relief Guaifenesin SOLUTION ORAL 20090105 OTC MONOGRAPH FINAL part341 H E B GUAIFENESIN 100 mg/5mL N 20181231 37808-289_75602309-5bed-446b-b538-ad42e279a993 37808-289 HUMAN OTC DRUG VANILLA CREAM AND APPLE BLOSSOM ANTIBACTERIAL MOISTURIZING HAND SP TRICLOSAN LIQUID TOPICAL 20101223 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .3 mL/100mL N 20181231 37808-290_d1ac225d-65e4-4f3f-acd2-ae69f2491298 37808-290 HUMAN OTC DRUG JASMINE TEA AND BASIL ANTIBACTERIAL HAND SP TRICLOSAN LIQUID TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .3 mL/100mL N 20181231 37808-291_1d7af611-bb60-42e7-98e3-247ad9832486 37808-291 HUMAN OTC DRUG CACTUS FLOWER AND MANGO ANTIBACTERIAL DEEP CLEANSING HAND SP TRICLOSAN LIQUID TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .3 mL/100mL N 20181231 37808-292_ccefeaa7-825d-4a20-baf2-3acaf4418f1e 37808-292 HUMAN OTC DRUG WHITE LAVENDER AND MINT ANTIBACTERIAL MOISTURIZING HAND SP TRICLOSAN LIQUID TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN .3 mL/100mL N 20181231 37808-294_00b97aa0-26c3-4fdf-bb5e-1ca1b733b958 37808-294 HUMAN OTC DRUG HILL COUNTRY ESSENTIALS ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20121212 OTC MONOGRAPH NOT FINAL part333E H.E.B. TRICLOSAN 1.5 mg/mL N 20181231 37808-296_a8111313-b49d-49b1-8a34-735742e954bc 37808-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20090515 OTC MONOGRAPH FINAL part358H HEB PYRITHIONE ZINC 14 mg/mL N 20181231 37808-297_12f767dc-7524-405c-9981-3e4e7cdb2d52 37808-297 HUMAN OTC DRUG ORCHID TRICLOSAN LIQUID TOPICAL 20120412 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .3 mL/100mL N 20181231 37808-299_bbce1326-074a-4c09-a9d5-46bb1a04e6bf 37808-299 HUMAN OTC DRUG Alcohol Free Cetylpyridinium cloride MOUTHWASH ORAL 20090416 OTC MONOGRAPH NOT FINAL part356 H-E-B CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 37808-301_1acf99ce-28cc-48ff-a542-1e8982783c13 37808-301 HUMAN OTC DRUG acid controller Famotidine TABLET ORAL 20151023 ANDA ANDA075400 H E B FAMOTIDINE 10 mg/1 N 20181231 37808-302_8c625e29-0b7c-f00a-0fc6-7709c52c10a2 37808-302 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20180124 ANDA ANDA200172 H-E-B RANITIDINE HYDROCHLORIDE 150 mg/1 N 20191231 37808-303_9b31ce5b-977d-fb58-8822-6bfb729a1b73 37808-303 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20180125 ANDA ANDA200172 H-E-B RANITIDINE HYDROCHLORIDE 150 mg/1 N 20191231 37808-304_c71d5ed2-345f-4c8a-a74e-319cee70a334 37808-304 HUMAN OTC DRUG rx act nasal original oxymetazoline hydrochloride SPRAY NASAL 19920203 OTC MONOGRAPH FINAL part341 H E B OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 37808-305_5f9c167c-5001-4041-96fe-e5cdf1f614cb 37808-305 HUMAN OTC DRUG HEB Antifungal Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C H E B CLOTRIMAZOLE 10 mg/g N 20181231 37808-306_3bbbc06e-a84e-4bcf-82cc-a7f05c584d21 37808-306 HUMAN OTC DRUG clear lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091008 ANDA ANDA090685 H E B POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 37808-308_96c05f14-1699-4260-95b2-7468bfb88502 37808-308 HUMAN OTC DRUG cold relief multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20090227 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 37808-309_8a5e5db5-19a9-4743-8a35-9af269d82e4e 37808-309 HUMAN OTC DRUG In Control Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170123 ANDA ANDA206393 H E B NICOTINE 4 mg/1 N 20181231 37808-311_7c241b9e-dadf-4dbc-b2f0-849c43a1cf1c 37808-311 HUMAN OTC DRUG 2 in 1 Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090515 OTC MONOGRAPH FINAL part358H HEB PYRITHIONE ZINC 10 mg/mL N 20181231 37808-314_4bd1a5e7-744c-411a-bc60-14dfea68e316 37808-314 HUMAN OTC DRUG HEB Severe Toothache Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B HEB BENZOCAINE 20 g/100g N 20181231 37808-316_1f691a38-28f3-474c-ba4b-5ccefd52b2b5 37808-316 HUMAN OTC DRUG MAX Cold, Flu, and Sore Throat ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL LIQUID ORAL 20140305 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 37808-317_34a10448-45e4-4406-a70a-87909df8d145 37808-317 HUMAN OTC DRUG H E B MAX SEVERE CONGESTION and COUGH Maxium Strength DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120914 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 37808-318_fa42da0d-13d2-4edb-8de3-64eabddd65ff 37808-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20090521 OTC MONOGRAPH NOT FINAL part356 HEB EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37808-319_15eb4676-5f6e-4c28-b5b9-4e45412dc37a 37808-319 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20150911 OTC MONOGRAPH NOT FINAL part348 H E B HYDROCORTISONE 1 g/100g N 20181231 37808-321_8d7f669f-18fb-4574-836c-2b97a25c5018 37808-321 HUMAN OTC DRUG Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080914 ANDA ANDA077355 H E B FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 37808-323_53b304ad-528d-4a26-be09-033514812162 37808-323 HUMAN OTC DRUG Infants Pain Relief Dye Free Acetaminophen SUSPENSION ORAL 20170531 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/5mL N 20181231 37808-325_fdeb8e6a-2e89-41e7-8ccb-bc5f4e46fb1a 37808-325 HUMAN OTC DRUG mucus er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170712 ANDA ANDA091009 H E B GUAIFENESIN 1200 mg/1 N 20181231 37808-326_6480719e-db0b-42e5-bc3f-874b23c28fea 37808-326 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20050212 20181210 OTC MONOGRAPH NOT FINAL part334 H E B BISACODYL 5 mg/1 E 20171231 37808-327_de39dbc0-77c6-4cba-901c-25b3fd09aa35 37808-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 H E B BISACODYL 5 mg/1 N 20181231 37808-329_a151c232-8819-4275-a102-2ee98b69e2a2 37808-329 HUMAN OTC DRUG Antihistamine Allergy Diphenhydramine HCl TABLET, COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37808-332_cdfe6525-7dec-4909-a499-129bbdf40d7f 37808-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19941014 OTC MONOGRAPH NOT FINAL part334 H E B MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 37808-333_a67ea2d8-b415-4468-9e7a-bae4172428a0 37808-333 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 H-E-B ACETAMINOPHEN 650 mg/1 N 20181231 37808-335_635f5c66-55fa-4814-806d-e5f6d2e975bf 37808-335 HUMAN OTC DRUG night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20130207 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 37808-339_35e5a528-faa4-4dc5-aa87-3c0e0ff59e9f 37808-339 HUMAN OTC DRUG all day pain relief Naproxen sodium TABLET, FILM COATED ORAL 20080212 ANDA ANDA074661 H E B NAPROXEN SODIUM 200 mg/1 N 20181231 37808-344_062fd73e-2fc0-4815-8605-15c4790f54ba 37808-344 HUMAN OTC DRUG in control Nicotine Nicotine Polacrilex LOZENGE ORAL 20070725 ANDA ANDA077007 H E B NICOTINE 2 mg/1 N 20181231 37808-346_39086850-1a8a-4b17-b778-a37f36ad4108 37808-346 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate TABLET ORAL 20110506 OTC MONOGRAPH FINAL part335 H E B BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 37808-348_1a3d2f30-6931-4e4f-8b71-0e8138ed9ee6 37808-348 HUMAN OTC DRUG Cold and Allergy phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20160601 OTC MONOGRAPH FINAL part341 H E B PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 37808-349_1dfecd8c-d7a3-4f46-b6b8-e98c33398c17 37808-349 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20170123 ANDA ANDA206394 H E B NICOTINE 2 mg/1 N 20181231 37808-351_176a7c7c-01cc-445e-868d-3f950ac1605e 37808-351 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20140411 ANDA ANDA200536 H E B RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 37808-352_8ccc1a17-cde4-4d9f-9a9d-d79e8a1b232d 37808-352 HUMAN OTC DRUG In Control Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20071213 ANDA ANDA078547 H E B NICOTINE 2 mg/1 N 20181231 37808-359_631a0613-3ee2-4649-b7d8-f1529623e701 37808-359 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 19910809 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 37808-363_e057f5e1-88f5-4cb5-b1d0-191634553ae8 37808-363 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20020610 ANDA ANDA074937 H E B IBUPROFEN 100 mg/5mL N 20181231 37808-367_14dd4e12-c640-348a-e054-00144ff8d46c 37808-367 HUMAN OTC DRUG Mucus Relief Sinus Severe Congestion Relief ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20150401 OTC MONOGRAPH FINAL part341 HEB ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 37808-368_df6fbdff-f101-4780-8ea5-95c1ac7222a4 37808-368 HUMAN OTC DRUG rx act all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20090212 ANDA ANDA074661 H E B NAPROXEN SODIUM 220 mg/1 N 20181231 37808-369_2ed358d8-b217-4710-a0c8-fc28a4972576 37808-369 HUMAN OTC DRUG hydrocortisone anti itch Hydrocortisone CREAM TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part348 H E B HYDROCORTISONE 1 g/100g N 20181231 37808-370_3307ae1c-d367-4d42-89db-13647357e1dc 37808-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20151122 OTC MONOGRAPH NOT FINAL part333A HEB ALCOHOL 70 mL/100mL N 20181231 37808-374_c45a064c-60c3-4bd0-bc60-7d3f5713e058 37808-374 HUMAN OTC DRUG migraine formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20020515 ANDA ANDA075794 H E B ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 37808-375_0501e919-e938-4581-9aef-bfe8c2e20f5b 37808-375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 H E B LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 37808-379_6fc2bbc4-3483-4b41-8a23-e822cd683bb2 37808-379 HUMAN OTC DRUG Allergy Diphenhydramine HCl SOLUTION ORAL 19870715 OTC MONOGRAPH FINAL part341 H E B DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 37808-384_09525540-6b49-4e32-943f-9168dc50b278 37808-384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120830 ANDA ANDA091135 H E B DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 37808-386_94861f03-69a1-4450-8cc3-b2b1ad2f06e7 37808-386 HUMAN OTC DRUG Sleep-Aid Doxylamine succinate TABLET ORAL 20020411 20191201 ANDA ANDA040564 H E B DOXYLAMINE SUCCINATE 25 mg/1 N 20191231 37808-390_40a37065-6db3-4fcf-b00e-bcd5d38e3e59 37808-390 HUMAN OTC DRUG Menstrual Complete Maximum Strength Acetaminophen, Caffeine, Pyrilamine maleate TABLET, FILM COATED ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 37808-393_6e428682-9289-4c6e-a662-f389b168f315 37808-393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 H E B IBUPROFEN 200 mg/1 N 20181231 37808-396_9a27a52f-1f66-414c-8bef-fc5b081b59a6 37808-396 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19920609 OTC MONOGRAPH NOT FINAL part334 H E B MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 37808-397_8b137816-bb9a-4d16-9d77-49bf9f1b345b 37808-397 HUMAN OTC DRUG Vaproizing Camphor LIQUID RESPIRATORY (INHALATION) 20101006 OTC MONOGRAPH FINAL part341 H E B CAMPHOR (NATURAL) 62 mg/mL N 20181231 37808-398_3e361735-70dc-6941-e054-00144ff88e88 37808-398 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20160923 OTC MONOGRAPH NOT FINAL part334 H E B GLYCERIN 2 g/1 N 20181231 37808-399_3e361735-70eb-6941-e054-00144ff88e88 37808-399 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20160923 OTC MONOGRAPH NOT FINAL part334 H E B GLYCERIN 1 g/1 N 20181231 37808-401_491e3710-9a15-4b07-ae22-923bd1152ecc 37808-401 HUMAN OTC DRUG omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150403 NDA NDA022032 H E B OMEPRAZOLE 20 mg/1 N 20181231 37808-404_8d82e70b-ac16-4beb-97ab-05e60936021a 37808-404 HUMAN OTC DRUG minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20120301 ANDA ANDA091344 H E B MINOXIDIL 5 g/100g N 20181231 37808-405_491e9055-7981-4d56-9acf-3b267e8eab0c 37808-405 HUMAN OTC DRUG ORCHID BY H E B VANILLA BROWN SUGAR ETHYL ALCOHOL LIQUID TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 650 mg/mL N 20181231 37808-405_706297f9-9ab3-4ef1-ab50-5bcf901c3ba0 37808-405 HUMAN OTC DRUG ORCHID BY H E B VANILLA BROWN SUGAR ETHYL ALCOHOL LIQUID TOPICAL 20140302 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 650 mg/mL N 20181231 37808-407_f68a77fc-6242-4aec-aa80-11701f0231b9 37808-407 HUMAN OTC DRUG Mucus Multi Symptom Cold Relief Childrens Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20160731 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN 5; 2.5; 100 mg/5mL; mg/5mL; mg/5mL N 20181231 37808-409_abb60da2-4384-4fd4-9236-4614de58233f 37808-409 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19960325 OTC MONOGRAPH FINAL part340 H E B CAFFEINE 200 mg/1 N 20181231 37808-410_5c37fd1f-598e-8f16-e053-2a91aa0a28b3 37808-410 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110101 ANDA ANDA079174 HEB IBUPROFEN 200 mg/1 N 20181231 37808-412_37620f00-e097-1b13-e054-00144ff88e88 37808-412 HUMAN OTC DRUG HEB Nasal decongestant No Drip Extra Moisturizing Oxymetazoline Hydrochloride SOLUTION NASAL 20160615 OTC MONOGRAPH FINAL part341 H-E-B OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 37808-413_3d8a7e71-d81d-4ccb-86a7-799b6418104a 37808-413 HUMAN OTC DRUG DANDRUFF SHAMPOO DAILY CLEAN FOR NORMAL HAIR PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC 1 mL/100mL N 20181231 37808-414_3b262473-ac5e-425f-9b39-d15f8263753f 37808-414 HUMAN OTC DRUG DANDRUFF CONDITIONER DAILY CLEAN FOR NORMAL HAIR PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC .5 mL/100mL N 20181231 37808-415_87b6e89c-b053-4e48-84ef-f47707f6752a 37808-415 HUMAN OTC DRUG DANDRUFF 2 IN 1 SHAMPOO AND CONDITIONER DAILY CLEAN FOR NORMAL HAIR PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC 1 mL/100mL N 20181231 37808-416_44d69334-ed46-4d60-b656-51d45c7bebd0 37808-416 HUMAN OTC DRUG DANDRUFF SHAMPOO DRY SCALP RECOVERY PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC 1 mL/100mL N 20181231 37808-417_3dbd14e2-b54c-4f65-a12e-37ae590470d3 37808-417 HUMAN OTC DRUG DANDRUFF CONDITIONER DRY SCALP RECOVERY PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC .5 mL/100mL N 20181231 37808-418_f244db1f-cd9e-4a12-aa28-d3c1875fc573 37808-418 HUMAN OTC DRUG DANDRUFF 2 IN 1 SHAMPOO AND CONDITIONER DRY SCALP RECOVERY PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC 1 mL/100mL N 20181231 37808-419_3ceec403-9632-44cb-a7e2-8858c9598866 37808-419 HUMAN OTC DRUG DANDRUFF 2 IN 1 SHAMPOO AND CONDITIONER SHINY SMOOTH PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20091020 OTC MONOGRAPH FINAL part358 HEB PYRITHIONE ZINC 1 mL/100mL N 20181231 37808-422_72659c72-4359-4567-83bc-3472ceec7a57 37808-422 HUMAN OTC DRUG In Control Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050615 ANDA ANDA078326 H E B NICOTINE 4 mg/1 N 20181231 37808-423_5b62334b-ffcb-4418-ad4a-fbc249007fc8 37808-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 HEB IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 37808-424_530448e2-f128-4609-a3e7-01d4b8fe0edf 37808-424 HUMAN OTC DRUG HEB DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20111223 OTC MONOGRAPH FINAL part358H HEB PYRITHIONE ZINC 1 mL/100mL N 20181231 37808-425_55af2c65-6db9-4abc-94e6-df88b99dfc60 37808-425 HUMAN OTC DRUG Allergy Relief Fexofenadine HCl TABLET, FILM COATED ORAL 20110824 ANDA ANDA076447 H E B FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 37808-426_8bd3f5e8-5a8f-4d6a-b257-c315eec66318 37808-426 HUMAN OTC DRUG Tioconazole 1 Tioconazole OINTMENT VAGINAL 20160509 ANDA ANDA075915 H E B TIOCONAZOLE 6.5 g/100g N 20181231 37808-428_65582a77-2691-457e-b746-357462cf5fe3 37808-428 HUMAN OTC DRUG Rx Act Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20010710 OTC MONOGRAPH FINAL part332 H E B DIMETHICONE 125 mg/1 N 20181231 37808-431_2263b1e0-1109-4c48-8f5d-e929ddc2dbb1 37808-431 HUMAN OTC DRUG nighttime sleep aid Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20091009 OTC MONOGRAPH FINAL part338 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37808-434_fbf30384-fa7d-4524-ad14-ceadb9d2fc4e 37808-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20160627 OTC MONOGRAPH NOT FINAL part356 HEB EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37808-435_3fe99279-6ebd-453a-b2e8-d518435f0ade 37808-435 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20150821 OTC MONOGRAPH FINAL part355 H-E-B SODIUM FLUORIDE .2 mg/mL N 20181231 37808-439_5bf9ec10-bf19-4dda-a6bd-9735a893c29e 37808-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160804 OTC MONOGRAPH NOT FINAL part333A H E B ALCOHOL 700 mg/mL N 20181231 37808-443_faaa9219-2673-485e-bd84-71bdb23b3e47 37808-443 HUMAN OTC DRUG Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20170330 ANDA ANDA078104 H E B TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 37808-445_49c70a7f-de72-4989-958e-1fd1c83968df 37808-445 HUMAN OTC DRUG flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140320 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 37808-446_db81155f-e727-4b6e-9873-b70313b4bdfc 37808-446 HUMAN OTC DRUG Mucus Relief D Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20160322 ANDA ANDA091071 H E B GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 37808-447_30c49f15-39be-4df6-833c-7c9c4d2eb170 37808-447 HUMAN OTC DRUG Childrens Pain Reliever Acetaminophen TABLET, CHEWABLE ORAL 20050203 20201128 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 80 mg/1 N 20191231 37808-450_9bca04b4-f746-44a4-8de1-2acc252432ca 37808-450 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/1 N 20181231 37808-453_361faefc-c607-4e8d-9494-dacfbe0e1ebc 37808-453 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 H E B PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20191231 37808-455_e50eb0a6-2f3c-4ef0-b20b-bd9728c25b59 37808-455 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051001 ANDA ANDA075077 H E B ACETAMINOPHEN 650 mg/1 N 20181231 37808-456_0e255b67-89b0-4bc3-b9f8-00540de2a36a 37808-456 HUMAN OTC DRUG In Control Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061013 ANDA ANDA076777 H E B NICOTINE 2 mg/1 N 20181231 37808-458_7a07a7c9-a4ec-408c-8560-db8fe5b713a9 37808-458 HUMAN OTC DRUG Rx Act all day allergy relief Cetirizine Hydrochloride TABLET ORAL 20080131 ANDA ANDA078336 H E B CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 37808-459_fd88a5e3-7b98-4fb8-9b70-55bab9b4b1c3 37808-459 HUMAN OTC DRUG night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20120204 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 37808-466_1a44ccbb-c446-4694-9843-b45d3e845195 37808-466 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Non-Drowsy Acetaminophen, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20191231 37808-470_de699d56-9424-4c8d-8e90-b67aef673d2d 37808-470 HUMAN OTC DRUG Day Time Cold Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130830 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 37808-471_1ab60698-9f8e-4864-84e6-ca5bd5b383ec 37808-471 HUMAN OTC DRUG hydrocortisone hydrocortisone OINTMENT TOPICAL 20140118 OTC MONOGRAPH NOT FINAL part348 H E B HYDROCORTISONE 1 g/100g N 20181231 37808-476_2cbc42d8-ec9d-40a3-90f8-890e6c56dc7e 37808-476 HUMAN OTC DRUG Allergy Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20060117 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 37808-477_c8b8c25c-481a-4738-8b5d-eb62cacd20ea 37808-477 HUMAN OTC DRUG fiber laxative Calcium polycarbophil TABLET, FILM COATED ORAL 20011031 OTC MONOGRAPH NOT FINAL part334 H E B CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 37808-480_5ef6e025-5b7a-4d6a-b1fb-e1d7e36d1d3d 37808-480 HUMAN OTC DRUG Night Time Liquid Caps Cold Flu Multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130814 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 37808-481_1c3bf9bc-1702-4291-b649-935451de807e 37808-481 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 20160229 OTC MONOGRAPH FINAL part341 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 37808-482_53a34f84-f670-4ce5-b38b-a55ff4a2f123 37808-482 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen SUSPENSION ORAL 20150308 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/5mL N 20181231 37808-486_91d10ad9-0fbd-47b0-a73d-4f9f674a97c6 37808-486 HUMAN OTC DRUG Senna Laxative Sennosides TABLET ORAL 20160430 OTC MONOGRAPH NOT FINAL part334 H E B SENNOSIDES 8.6 mg/1 N 20181231 37808-491_274366e9-c958-4233-9eff-38619351e71c 37808-491 HUMAN OTC DRUG HEB Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 HEB SODIUM FLUORIDE .243 g/100g N 20181231 37808-492_3c52a2bf-0922-4258-a89f-ec4dadc352d5 37808-492 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20160430 OTC MONOGRAPH NOT FINAL part334 H E B SENNOSIDES 25 mg/1 N 20181231 37808-495_b2c76f88-e4d4-4936-82dc-988f01df80b8 37808-495 HUMAN OTC DRUG ORCHID SUGAR COOKIE ETHYL ALCOHOL LIQUID TOPICAL 20130912 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 650 mg/mL N 20181231 37808-498_76073eb3-ae9f-4228-abec-4b7f48685d88 37808-498 HUMAN OTC DRUG mucus relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130319 ANDA ANDA078912 H E B GUAIFENESIN 600 mg/1 N 20181231 37808-500_6402a5b3-3e29-47aa-a37c-0c54605347c7 37808-500 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 19970224 ANDA ANDA074661 H E B NAPROXEN SODIUM 220 mg/1 N 20181231 37808-501_438e4465-76b7-4401-90c8-fa7dc53e50da 37808-501 HUMAN OTC DRUG nausea relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20141104 UNAPPROVED DRUG OTHER H E B DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 37808-502_0b963dfe-0087-453b-90ff-ed7e073127db 37808-502 HUMAN OTC DRUG nasal Oxymetazoline Hydrochloride SPRAY NASAL 20150219 OTC MONOGRAPH FINAL part341 H E B OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 37808-503_c1aa7efa-4be1-4c8f-8994-661dd60e1aa9 37808-503 HUMAN OTC DRUG Dual Action Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160407 ANDA ANDA077355 H E B FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 37808-504_bd767497-90a6-4121-8672-4fd523f8942d 37808-504 HUMAN OTC DRUG Tussin Cough Dextromethorphan Hydrobromide LIQUID ORAL 19920505 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 37808-507_d2c13949-f82c-45a4-b53a-5a677e30980a 37808-507 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20151130 ANDA ANDA091429 H E B RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 37808-509_ed18c744-172c-4435-b126-4e0623cc49da 37808-509 HUMAN OTC DRUG Advanced Guard Cetylpyridinium chloride RINSE ORAL 20130625 OTC MONOGRAPH NOT FINAL part356 H-E-B CETYLPYRIDINIUM CHLORIDE 1 mg/100mL N 20181231 37808-511_fc905e64-d4e5-4614-a431-8b8b537aa371 37808-511 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20140728 ANDA ANDA090821 H E B NICOTINE 4 mg/1 N 20181231 37808-512_3553f572-64c4-46c4-b7e3-600c33caf7b2 37808-512 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20171222 OTC MONOGRAPH NOT FINAL part333A HEB BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/9mL; mg/9mL N 20181231 37808-513_e56b0f84-bdce-48e0-8b84-1a98b22268e7 37808-513 HUMAN OTC DRUG Salicylic Acid One Step Corn Remover PATCH TOPICAL 20171222 OTC MONOGRAPH FINAL part358F HEB SALICYLIC ACID 40 mg/61 N 20181231 37808-514_cd0fc54a-2817-4185-836c-09294f84bfd9 37808-514 HUMAN OTC DRUG Tolnaftate Foot Odor Control Spray AEROSOL, SPRAY TOPICAL 20120105 OTC MONOGRAPH FINAL part333C HEB TOLNAFTATE 1.13 g/113g N 20181231 37808-515_25a36fd1-3e39-4d08-8aa9-4fb17dd3c528 37808-515 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20171222 OTC MONOGRAPH FINAL part333C HEB TOLNAFTATE 1.3 g/130g N 20181231 37808-516_c46b8e6a-36e5-43c1-ae10-f1ee5264b56f 37808-516 HUMAN OTC DRUG Rx Act Tussin CF Cough and Cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 19960718 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 37808-519_9e5860e6-f5f8-4515-ac71-99d1215df5ce 37808-519 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20090512 OTC MONOGRAPH FINAL part347 H E B PETROLATUM 100 g/100g N 20181231 37808-520_24a73f32-611f-43bd-9765-d0bc689c5e44 37808-520 HUMAN OTC DRUG Miconazole Nitrate Antifungal Liquid Continuous Spray AEROSOL, SPRAY TOPICAL 20120117 OTC MONOGRAPH FINAL part333C HEB MICONAZOLE NITRATE 3 g/150g N 20181231 37808-521_47e59263-32cc-4176-bd7e-18dab0533d4d 37808-521 HUMAN OTC DRUG Tolnaftate Antifungal Continuous Liquid Spray AEROSOL, SPRAY TOPICAL 20171222 OTC MONOGRAPH FINAL part333C HEB TOLNAFTATE 1.5 g/150g N 20181231 37808-522_061864a9-2ad4-405c-a73a-d11a6a433c29 37808-522 HUMAN OTC DRUG Salicylic acid Medicated Callus Removers Extra Thick PATCH TOPICAL 20171222 OTC MONOGRAPH FINAL part358F HEB SALICYLIC ACID 40 mg/41 N 20181231 37808-523_5370fb2c-d518-428f-a0f1-6d8c6971d6be 37808-523 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20171222 OTC MONOGRAPH FINAL part358F HEB SALICYLIC ACID 40 mg/41 N 20181231 37808-525_d4159aa6-7589-433d-9266-31d30d118890 37808-525 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20171222 OTC MONOGRAPH FINAL part358F HEB SALICYLIC ACID 40 mg/91 N 20181231 37808-526_612315e3-80db-4da8-9268-6451548d2cec 37808-526 HUMAN OTC DRUG Diphenhydramine HCl and Zinc Acetate Extra Strength Itch Relief SPRAY TOPICAL 20171222 OTC MONOGRAPH NOT FINAL part348 HEB DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.52; .076 g/76g; g/76g N 20181231 37808-527_13f87225-b98b-45f5-9717-d1f79534c717 37808-527 HUMAN OTC DRUG Childrens Allergy Relief Fexofenadine Hydrochloride SUSPENSION ORAL 20150701 ANDA ANDA203330 HEB FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 37808-530_9df80626-bbfe-48c5-8ee3-4cafd2bd828c 37808-530 HUMAN OTC DRUG Tolnafate Tolnaftate Powder Spray AEROSOL, SPRAY TOPICAL 20171222 OTC MONOGRAPH FINAL part333C HEB TOLNAFTATE 1.3 g/130g N 20181231 37808-532_da556a51-5184-4d2a-84ed-767ed8d787eb 37808-532 HUMAN OTC DRUG In Control Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061013 ANDA ANDA076779 H E B NICOTINE 4 mg/1 N 20181231 37808-536_c51686c9-e4f0-4387-a9a8-cb772597d782 37808-536 HUMAN OTC DRUG bacitracin Bacitracin OINTMENT TOPICAL 19910615 OTC MONOGRAPH FINAL part333B H E B BACITRACIN 500 [USP'U]/g N 20181231 37808-539_b0556027-d009-4557-addd-8cb8e00e91a1 37808-539 HUMAN OTC DRUG HEB DayTime Flu And Severe Cold And Cough Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 HEB ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 37808-541_569bf1cd-f186-4c19-96f9-4edc4692e724 37808-541 HUMAN OTC DRUG Hydrocortisone maximum strength Hydrocortisone CREAM TOPICAL 20100823 OTC MONOGRAPH NOT FINAL part348 H E B HYDROCORTISONE 1 g/100g N 20181231 37808-546_14f187c9-4e82-4c30-82af-0910536b7e17 37808-546 HUMAN OTC DRUG complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080914 ANDA ANDA077355 H E B FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 37808-550_c6efdde5-76c9-447d-bf6e-6fba9ea34721 37808-550 HUMAN OTC DRUG all day allergy relief Cetirizine Hydrochloride TABLET ORAL 20140208 ANDA ANDA078336 H E B CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 37808-552_d47b813b-0857-4bfa-a8e2-d6bcadf5aef6 37808-552 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20140501 ANDA ANDA075232 H E B LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 37808-556_64e25475-f50e-4023-bc43-660b6302f34a 37808-556 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 37808-571_17be7da6-2a7a-4a0c-96a5-9b30254b2bd5 37808-571 HUMAN OTC DRUG Allergy Relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110622 ANDA ANDA076447 H E B FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 37808-576_de64a91f-4b66-472e-b2e6-0844c1f70888 37808-576 HUMAN OTC DRUG Alcohol Free Refreshing Mint Sodium fluoride MOUTHWASH ORAL 20150427 OTC MONOGRAPH FINAL part355 HEB SODIUM FLUORIDE 10.41 mg/mL N 20181231 37808-578_c7b2c39f-6a25-40c0-9da4-ac6ee314946d 37808-578 HUMAN OTC DRUG tussin dm Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20060530 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 37808-594_e622358f-2263-4dad-af33-8decdffa8418 37808-594 HUMAN OTC DRUG Mucus Relief Cough Childrens Dextromethorphan HBr, Guaifensin LIQUID ORAL 20160731 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 37808-597_1fff3315-146f-4d9f-9d4c-8582e242ecf3 37808-597 HUMAN OTC DRUG HEB Day Time Night Time Severe Cold and Flu acetaminophen, dextromethorphan HBr, doxylamine succinate, guaifenesin, phenylephrine HCl KIT 20160414 OTC MONOGRAPH FINAL part341 H E B N 20181231 37808-600_fc46cf51-8c18-4051-ab1a-04351ece68f7 37808-600 HUMAN OTC DRUG Aspirin 81 mg Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 H E B ASPIRIN 81 mg/1 N 20181231 37808-601_79daf0bb-a289-461c-81be-745ca6c5f8a0 37808-601 HUMAN OTC DRUG Tussin Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20141023 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 37808-603_a7c63ebb-5d5e-4303-b0e3-9834f52bc927 37808-603 HUMAN OTC DRUG daytime severe cold and flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20160411 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 37808-604_a340ed68-debb-4c1e-97eb-82f6e9e3854f 37808-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19890215 ANDA ANDA072096 H E B IBUPROFEN 200 mg/1 N 20181231 37808-612_587e4891-17b0-4c52-ac9d-c35fe54fb291 37808-612 HUMAN OTC DRUG 2 in 1 Dandruff Pyrithione zinc SHAMPOO TOPICAL 20161019 OTC MONOGRAPH FINAL part358H H E B PYRITHIONE ZINC 1 g/mL N 20181231 37808-613_868e3505-5e6b-4d6d-8129-92523e41ff58 37808-613 HUMAN OTC DRUG HEB Dandruff Selenium Sulfide SHAMPOO TOPICAL 20110808 OTC MONOGRAPH FINAL part358H H E B SELENIUM SULFIDE 1 mL/100mL N 20181231 37808-620_18a520bc-988f-4985-9721-497186a28683 37808-620 HUMAN OTC DRUG Motion Sickness Less Drowsy Meclizine HCl TABLET ORAL 20160831 OTC MONOGRAPH FINAL part336 H E B MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 37808-622_34c7bcd3-203f-4630-894d-3739a1576c8d 37808-622 HUMAN OTC DRUG itch relief Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part348 H E B DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 37808-627_2115e58f-3db8-4e97-a3ec-25fca8edd7e2 37808-627 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, COATED ORAL 20171031 OTC MONOGRAPH FINAL part343 H E B ASPIRIN 81 mg/1 N 20181231 37808-631_535a6531-3372-4206-b97b-f26a16b6d80c 37808-631 HUMAN OTC DRUG naproxen sodium Naproxen sodium TABLET, FILM COATED ORAL 20171114 ANDA ANDA074661 H E B NAPROXEN SODIUM 220 mg/1 N 20181231 37808-637_1ed01f1f-9a4a-40ac-b4ae-813a197a68c8 37808-637 HUMAN OTC DRUG Eye Lubricant polyethylene glycol, propylene glycol LIQUID OPHTHALMIC 20121205 OTC MONOGRAPH FINAL part349 H E B POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/15mL; mg/15mL N 20181231 37808-645_1790afa2-8e6f-4f4d-b63e-81fd4706f05d 37808-645 HUMAN OTC DRUG Loperamide Hydrochloride loperamide HCl SUSPENSION ORAL 20120305 ANDA ANDA091292 H E B LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 37808-647_1a3ad4b7-92ba-4ecc-8e5b-f34af3ab87d0 37808-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19910809 ANDA ANDA072096 H E B IBUPROFEN 200 mg/1 N 20191231 37808-652_2f9439bb-e808-4c54-ba61-f75f117c8b37 37808-652 HUMAN OTC DRUG naproxen sodium Naproxen Sodium TABLET ORAL 20171114 ANDA ANDA074661 H E B NAPROXEN SODIUM 220 mg/1 N 20181231 37808-656_3fcb6bb6-32c2-4957-a02b-a3fe17bf9ce0 37808-656 HUMAN OTC DRUG DayTime acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20060802 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 37808-664_85d673dd-cc26-483a-a924-6b79796983d6 37808-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20090519 OTC MONOGRAPH NOT FINAL part356 H-E-B EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37808-666_6ec21d8c-cc2b-4e7c-9d08-d9665bbd36e7 37808-666 HUMAN OTC DRUG rx act cough and sore throat Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060704 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 37808-668_5427703f-3f11-4521-9647-5b6e03f7e362 37808-668 HUMAN OTC DRUG night time cough relief Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20030225 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 37808-676_b733216a-dab0-4e22-99ff-e74d6b2696ab 37808-676 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 H E B BISACODYL 5 mg/1 N 20181231 37808-679_5fb57e68-ec99-4e0f-93a9-9b2061d49ab8 37808-679 HUMAN OTC DRUG triple antibiotic plus maximum strength Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20101105 OTC MONOGRAPH FINAL part333B H E B BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 37808-686_69c0fc59-e0cf-41b3-b9a6-9ae41559ce4c 37808-686 HUMAN OTC DRUG Risk Force Invisible Solid Antiperspirant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110203 OTC MONOGRAPH FINAL part350 H-E-B ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17.3 g/100g E 20171231 37808-687_d47657ca-9a1a-4eb2-957d-28a1d3ff0922 37808-687 HUMAN OTC DRUG Risk Friction Invisible Solid Antiperspirant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110205 OTC MONOGRAPH FINAL part350 H-E-B ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17.3 g/100g E 20171231 37808-688_54e568a7-9cce-4bb8-af10-8d0ed5b514bb 37808-688 HUMAN OTC DRUG Risk Seduction Invisible Solid Antiperspirant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110206 OTC MONOGRAPH FINAL part350 H-E-B ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17.3 g/100g E 20171231 37808-689_2fe9fef3-7d0e-49f0-95a9-2e9e34043098 37808-689 HUMAN OTC DRUG Risk True Invisible Solid Antiperspirant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110207 OTC MONOGRAPH FINAL part350 H-E-B ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17.3 g/100g E 20171231 37808-690_291cca03-a3d9-48ca-8242-7fde5f88aca8 37808-690 HUMAN OTC DRUG Antihistamine Allergy Diphenhydramine Hydrochloride TABLET ORAL 20111201 OTC MONOGRAPH FINAL part336 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37808-693_5b678430-366c-4c75-9e20-e7da833f9e33 37808-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20130227 OTC MONOGRAPH NOT FINAL part334 HEB MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 37808-704_59a439a8-dee1-af93-e053-2991aa0ad23d 37808-704 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20110101 OTC MONOGRAPH NOT FINAL part343 HEB ACETAMINOPHEN 500 mg/1 N 20181231 37808-706_aba44277-11f9-40a8-a148-4a2f98f1201f 37808-706 HUMAN OTC DRUG Gas Relief Infants Simethicone EMULSION ORAL 20081011 OTC MONOGRAPH FINAL part332 H E B DIMETHICONE 20 mg/.3mL N 20181231 37808-709_21567c0f-abba-4a40-a0b9-5ce49b3d9648 37808-709 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060704 ANDA ANDA077349 H E B IBUPROFEN 200 mg/1 N 20181231 37808-710_3cf77597-d29c-4b8e-b57b-0ac231ee3124 37808-710 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20151125 ANDA ANDA091429 H E B RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 37808-713_b5dcf3df-2628-49c7-9d96-64886bebe631 37808-713 HUMAN OTC DRUG naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20171003 ANDA ANDA074661 H E B NAPROXEN SODIUM 220 mg/1 N 20181231 37808-717_47b896c7-bb47-4343-85fe-c44b789f4b05 37808-717 HUMAN OTC DRUG Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20161031 OTC MONOGRAPH FINAL part332 H E B DIMETHICONE 125 mg/1 E 20171231 37808-720_c559d21f-dab6-48fd-a128-5cca54c78d53 37808-720 HUMAN OTC DRUG ANTIBACTERIAL HAND SOAP FOR SENSITIVE SKIN TRICLOSAN LOTION/SHAMPOO TOPICAL 20100308 OTC MONOGRAPH NOT FINAL part333 HEB TRICLOSAN .115 mL/100mL N 20181231 37808-721_5cf45772-603a-4ad0-89d6-c8cedba7dc47 37808-721 HUMAN OTC DRUG HILL COUNTRY ESSENTIALS ANTIBACTERIAL HAND BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141209 OTC MONOGRAPH NOT FINAL part333E H E B BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 37808-722_717bd705-5bfa-4577-883a-14224c9a551b 37808-722 HUMAN OTC DRUG HILL COUNTRY ESSENTIALS ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20150118 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN 1.5 mg/mL N 20181231 37808-722_c1cbb794-ea4b-46b9-bc22-16a02fd7f71e 37808-722 HUMAN OTC DRUG HILL COUNTRY ESSENTIALS ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20150331 OTC MONOGRAPH NOT FINAL part333E H E B TRICLOSAN 1.5 mg/mL N 20181231 37808-724_06bf74f1-cf33-45ee-8463-c2a8e535fd6e 37808-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 HEB LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 37808-732_ddc8d73f-f4a1-42a7-89ee-420346820f61 37808-732 HUMAN OTC DRUG Omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate CAPSULE, GELATIN COATED ORAL 20170825 ANDA ANDA201361 H E B OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 N 20181231 37808-734_21221f3d-f617-4ae8-a363-1fb2b2952798 37808-734 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20140723 ANDA ANDA203690 H E B NICOTINE 2 mg/1 N 20181231 37808-737_25d909e1-56d8-4e0f-a06d-4d9832c3c806 37808-737 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100607 ANDA ANDA079114 H E B N 20181231 37808-747_8424220f-ac15-4ab9-b93f-2bb5da9ed581 37808-747 HUMAN OTC DRUG Pain Relief 8 HR Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170224 ANDA ANDA075077 H E B ACETAMINOPHEN 650 mg/1 N 20181231 37808-759_3bdff2e1-a0b4-4b42-b62b-bb270405417d 37808-759 HUMAN OTC DRUG pain relief Acetaminophen SUSPENSION ORAL 20110301 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/5mL N 20181231 37808-763_aec6a6ed-0297-4d74-8fef-179390534697 37808-763 HUMAN OTC DRUG nighttime severe cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20160411 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 37808-768_6403f4cf-5cb2-458b-e053-2a91aa0accbd 37808-768 HUMAN OTC DRUG Effervescent Orange Cold Relief Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20180130 OTC MONOGRAPH FINAL part341 H. E. Butt Grocery Company PHENYLEPHRINE BITARTRATE; ASPIRIN; CHLORPHENIRAMINE MALEATE 7.8; 325; 2 mg/1; mg/1; mg/1 N 20191231 37808-771_1ce16f5a-01e9-4647-bfdc-b7cb9d517380 37808-771 HUMAN OTC DRUG Muscle Rub Greaseless Menthol, methyl salicylate CREAM TOPICAL 20110725 OTC MONOGRAPH NOT FINAL part348 H E B MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g E 20171231 37808-773_47e1f883-b7a9-59c8-e054-00144ff8d46c 37808-773 HUMAN OTC DRUG Muscle Rub Ultra Camphor,Menthol, methyl salicylate CREAM TOPICAL 20110725 OTC MONOGRAPH NOT FINAL part348 H E B MENTHOL; CAMPHOR (NATURAL); MENTHYL SALICYLATE, (+/-)- 10; 4; 30 g/100g; g/100g; g/100g N 20181231 37808-785_6c9d6958-4ff6-4433-b029-3427bee26ddc 37808-785 HUMAN OTC DRUG allergy relief d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20180119 ANDA ANDA077170 H E B CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20191231 37808-792_59a421cf-dfb5-6685-e053-2a91aa0a9b3f 37808-792 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20130201 OTC MONOGRAPH NOT FINAL part343 HEB ACETAMINOPHEN 500 mg/1 N 20181231 37808-795_59a439a8-def7-af93-e053-2991aa0ad23d 37808-795 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20130201 OTC MONOGRAPH FINAL part341 HEB ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 37808-798_8c659f85-7aa6-4c5d-8e9d-c1c45dc901d6 37808-798 HUMAN OTC DRUG minoxidil for men Minoxidil SOLUTION TOPICAL 20100216 ANDA ANDA075598 H E B MINOXIDIL 3 g/60mL N 20181231 37808-799_981c7791-8c74-4f8b-80d9-0dc487838203 37808-799 HUMAN OTC DRUG tussin cough and chest congestion DM Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20160411 OTC MONOGRAPH FINAL part341 H E B DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 37808-801_c517487e-537d-4454-bbde-b82e49af1395 37808-801 HUMAN OTC DRUG Clean and Refresh Body Wash Moisturizing Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN .15 mL/100mL N 20181231 37808-802_886d4765-562c-49ee-a2b3-da864f58195f 37808-802 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140225 ANDA ANDA077958 H E B KETOTIFEN FUMARATE .35 mg/mL N 20181231 37808-804_9921a733-a304-4ae0-ace2-f5d59edf64d6 37808-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20150113 OTC MONOGRAPH NOT FINAL part333A H-E-B ISOPROPYL ALCOHOL 30 mg/mL N 20181231 37808-806_309adc66-f625-4825-819b-9688ccee8627 37808-806 HUMAN OTC DRUG HILL COUNTRY ESSENTIALS LAVENDER AND JASMINE TRICLOSAN LIQUID TOPICAL 20130404 OTC MONOGRAPH NOT FINAL part333E HEB TRICLOSAN 1.5 mg/mL N 20181231 37808-807_866ff440-7c19-4d48-a17d-959fb08b64cb 37808-807 HUMAN OTC DRUG Flu and Severe Cold and Cough Nighttime Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100922 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 37808-808_20c4f49b-230e-4bc1-ba7a-7976bae0d245 37808-808 HUMAN OTC DRUG Anticavity Rinse Sodium Fluoride MOUTHWASH ORAL 20100225 OTC MONOGRAPH FINAL part355 H-E-B SODIUM FLUORIDE .2 mg/mL N 20191231 37808-809_b1b41228-2bc4-4170-a107-520c1bb7f72e 37808-809 HUMAN OTC DRUG inControl alcohol Isopropyl Alcohol SWAB TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333A H E B ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 37808-810_e723ebfd-b701-4f61-aedc-d6d93d277ac8 37808-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20150618 OTC MONOGRAPH NOT FINAL part333A H-E-B ISOPROPYL ALCOHOL 500 mg/mL N 20181231 37808-816_dc83bb22-0d38-4a5c-ad2d-1ac33e221ede 37808-816 HUMAN OTC DRUG Dandruff Selenium sulfide SHAMPOO TOPICAL 20160925 OTC MONOGRAPH FINAL part358H HEB SELENIUM SULFIDE 10 mg/mL N 20181231 37808-817_1b1cfe3a-7cd2-44fc-8a12-0fa6fece5393 37808-817 HUMAN OTC DRUG rx act nasal sinus oxymetazoline hydrochloride SPRAY NASAL 20000825 OTC MONOGRAPH FINAL part341 H E B OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 37808-822_fe712f83-0fec-4144-9d41-27defb7f8cef 37808-822 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20150618 OTC MONOGRAPH FINAL part346 H-E-B WITCH HAZEL 979 mg/mL N 20181231 37808-825_18aff049-0a71-49e0-807f-259ca9a63b96 37808-825 HUMAN OTC DRUG miconazole 7 Miconazole nitrate CREAM VAGINAL 20060109 ANDA ANDA074760 H E B MICONAZOLE NITRATE 2 g/100g N 20181231 37808-831_512b36b7-d6b7-4b62-a048-fba863c51a76 37808-831 HUMAN OTC DRUG Flu and severe cold daytime nighttime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl KIT 20170811 OTC MONOGRAPH FINAL part341 H E B N 20181231 37808-832_5942724f-e11d-0fae-e053-2a91aa0a80b7 37808-832 HUMAN OTC DRUG Nasal decongestant Oxymetazoline Hydrochloride SOLUTION NASAL 20160615 OTC MONOGRAPH FINAL part341 H-E-B OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL N 20181231 37808-843_1888cd0d-38fb-49cc-8c10-6dab3cf82ef2 37808-843 HUMAN OTC DRUG hemorrhoidal Phenylephrine HCl, Witch hazel GEL TOPICAL 20110325 OTC MONOGRAPH FINAL part346 H E B PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g N 20181231 37808-851_c78ff819-628c-4005-8f51-8dd5dcfd2637 37808-851 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20021112 OTC MONOGRAPH FINAL part332 H E B ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 37808-852_8bab81f0-758b-422d-9ff3-597453006445 37808-852 HUMAN OTC DRUG Heartburn Relief Ranitidine TABLET, FILM COATED ORAL 20130723 ANDA ANDA091429 H E B RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 37808-854_1e8e0902-4164-4a05-8376-a02bcfd8900a 37808-854 HUMAN OTC DRUG In Control Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20071213 ANDA ANDA078546 H E B NICOTINE 4 mg/1 N 20181231 37808-855_6e04f6dd-a144-4d9f-81fa-aa6523531ccf 37808-855 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20150427 OTC MONOGRAPH NOT FINAL part356 HEB EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 37808-861_64accd4a-9481-4cc8-902a-5497c01fb37a 37808-861 HUMAN OTC DRUG HEB Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 HEB SODIUM FLUORIDE; POTASSIUM NITRATE 1.5; 5 g/g; g/g N 20181231 37808-864_85041f39-9ea6-46c8-8a89-3836ca4ff6ae 37808-864 HUMAN OTC DRUG Cold and Flu Relief Daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160531 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 37808-865_aabce1d7-5923-4870-9c04-b49f0eb2c94d 37808-865 HUMAN OTC DRUG body Menthol POWDER TOPICAL 20150205 OTC MONOGRAPH NOT FINAL part348 H-E-B MENTHOL 10 mg/g N 20181231 37808-870_193096a5-dbd5-4a89-aa75-332c43001ed1 37808-870 HUMAN OTC DRUG Allergy Eye Drops Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140225 ANDA ANDA077958 H E B KETOTIFEN FUMARATE .35 mg/mL N 20181231 37808-871_0f9038ed-f6a6-425c-b599-8906f2a1ce38 37808-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20150715 OTC MONOGRAPH NOT FINAL part333A H-E-B HYDROGEN PEROXIDE 30 mg/mL N 20181231 37808-873_9f978b10-868b-4e74-be4a-48c333bf6526 37808-873 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20070725 ANDA ANDA077007 H E B NICOTINE 4 mg/1 N 20181231 37808-875_dbf1f8f1-ed53-4bd0-ad78-d40a47425e45 37808-875 HUMAN OTC DRUG Deep Cleaning Astringent Salicylic Acid LIQUID TOPICAL 20120913 OTC MONOGRAPH FINAL part333D HEB SALICYLIC ACID 5 mg/mL N 20181231 37808-876_29fb8fa5-d817-469d-aae0-8aa94a4a5101 37808-876 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, COATED ORAL 20161027 ANDA ANDA076195 H E B RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 37808-884_dd8f50bd-4ad2-479e-944c-9b7dc7b6362f 37808-884 HUMAN OTC DRUG CHILDRENS ALLERGY cetirizine Hydrochloride SOLUTION ORAL 20101101 ANDA ANDA090254 H E B CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 37808-890_11ae03d9-754d-442c-9b55-1dbb60eb6d64 37808-890 HUMAN OTC DRUG Cold and Allergy Relief Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20160831 OTC MONOGRAPH FINAL part341 H E B CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 37808-896_cfb5cc6b-0c5e-4d9f-a3a2-a6b6e23aef2a 37808-896 HUMAN OTC DRUG HEB Brilliant White Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 HEB SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 37808-897_9e4e9b56-6fae-4918-b46e-c4ae9e6c78dc 37808-897 HUMAN OTC DRUG rx act ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990106 ANDA ANDA074937 H E B IBUPROFEN 100 mg/5mL N 20181231 37808-898_5a65a196-2326-448f-b79e-8b9d2c338234 37808-898 HUMAN OTC DRUG esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170922 ANDA ANDA207193 H E B ESOMEPRAZOLE 20 mg/1 N 20181231 37808-902_7a1dfd84-9340-48f1-ac0a-99e0e998e0a2 37808-902 HUMAN OTC DRUG Cold and Cough Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate SOLUTION ORAL 20140714 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 37808-904_e502273a-0bfc-4501-aab9-2faa4e92d98a 37808-904 HUMAN OTC DRUG flu and severe cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20170712 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 37808-906_6fe4441a-5e2c-4c39-b379-3b2478547a68 37808-906 HUMAN OTC DRUG rx act cold and allergy childrens phenylephrine hcl, brompheniramine maleate SOLUTION ORAL 20061016 OTC MONOGRAPH FINAL part341 H E B PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 2.5; 1 mg/5mL; mg/5mL N 20181231 37808-915_6fdd30c8-61ac-48e5-a556-93a6a4d45b65 37808-915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080229 NDA NDA022032 H E B OMEPRAZOLE 20 mg/1 N 20181231 37808-920_d3a07bdd-5382-4ad6-8d02-bdfa6b289b87 37808-920 HUMAN OTC DRUG cold multi symptom acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20151221 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 37808-921_8457b002-c5b3-4aa4-b356-71c8e0a23a58 37808-921 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 H E B IBUPROFEN 200 mg/1 N 20181231 37808-922_edeb7da7-44bd-44f7-aeb9-4d12eae51d7f 37808-922 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 H E B IBUPROFEN 200 mg/1 N 20181231 37808-932_342be6dd-3849-4d25-8d8b-43bb76140ef8 37808-932 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, FILM COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 37808-942_798c79c6-1e0d-4658-9285-883bf1139328 37808-942 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20170117 OTC MONOGRAPH FINAL part355 H-E-B SODIUM FLUORIDE .1 mg/mL N 20181231 37808-944_e9d54c86-dee1-44c9-a340-29c68a8b96cf 37808-944 HUMAN OTC DRUG hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20121025 OTC MONOGRAPH FINAL part346 H E B GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 37808-946_1fd904c0-68d3-4434-8c0a-d6a0a0d12266 37808-946 HUMAN OTC DRUG pain and fever Acetaminophen SUSPENSION ORAL 20111201 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 160 mg/5mL N 20181231 37808-947_779c3f32-42b9-475c-9e64-10edb33485ba 37808-947 HUMAN OTC DRUG Oil Free Acne Wash Salicylic Acid 2% LOTION TOPICAL 20150915 OTC MONOGRAPH FINAL part333D HEB SALICYLIC ACID 20.6 mg/mL N 20181231 37808-949_dd18d4b9-5df0-4b73-9e80-650ddcda8e10 37808-949 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20121010 OTC MONOGRAPH NOT FINAL part334 H E B MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 37808-950_1835a1fa-7284-425b-abf0-179ee427e2ae 37808-950 HUMAN OTC DRUG heartburn relief Ranitidine TABLET, FILM COATED ORAL 20111125 ANDA ANDA091429 H E B RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 37808-952_2a023134-702e-4fa3-96fd-4f43cd436787 37808-952 HUMAN OTC DRUG Hand Wash Benzalkonium chloride SOAP TOPICAL 20160717 OTC MONOGRAPH NOT FINAL part333A Harmon Stores, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 37808-953_3e2a2960-2f38-458f-95ae-35be47c48ccd 37808-953 HUMAN OTC DRUG Nasal Decongestant PE Sinus Congestion Relief Non-Drowsy / Maximum Strength Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 H E B PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 37808-957_eee4ac20-5d20-426a-8110-e1a23431261e 37808-957 HUMAN OTC DRUG in control nicotine Nicotine Polacrilex LOZENGE ORAL 20140723 ANDA ANDA203690 H E B NICOTINE 4 mg/1 N 20181231 37808-960_b216884c-ac64-487a-bd00-87ac3228c1a6 37808-960 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20150715 OTC MONOGRAPH FINAL part347 H-E-B PETROLATUM 1 g/g N 20181231 37808-961_4c7ffb19-50fa-4174-875d-9c9f28e1d058 37808-961 HUMAN OTC DRUG HEB Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 HEB SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 37808-966_067eb4ad-b01e-4ebb-8405-37f376594450 37808-966 HUMAN OTC DRUG ORCHID BY H E B JASMINE TEA AND BASIL ETHYL ALCOHOL LIQUID TOPICAL 20140602 OTC MONOGRAPH NOT FINAL part333E H E B ALCOHOL 620 mg/mL N 20181231 37808-968_5d579680-6bbf-1161-e053-2991aa0aead1 37808-968 HUMAN OTC DRUG HEB Calagesic Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 H E B ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 37808-970_63f053f3-6124-43ac-bf22-69c4f7b08754 37808-970 HUMAN OTC DRUG Antihistamine Allergy Diphenhydramine HCl CAPSULE ORAL 20110323 OTC MONOGRAPH FINAL part336 H E B DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 37808-971_72c637ae-0da8-4bca-abce-d75f71a49c12 37808-971 HUMAN OTC DRUG Nighttime Cold and Flu Relief Multi-Symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20160630 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 37808-973_d002a9c8-96f0-4879-83fe-5bb98fa6dc8a 37808-973 HUMAN OTC DRUG hydrocortisone hydrocortisone CREAM TOPICAL 20100927 OTC MONOGRAPH NOT FINAL part348 H E B HYDROCORTISONE 1 g/100g N 20181231 37808-980_e0c84c69-67de-458e-a566-29e225918832 37808-980 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET ORAL 19910615 OTC MONOGRAPH NOT FINAL part343 H E B ACETAMINOPHEN 500 mg/1 N 20181231 37808-986_e73f7c6c-01d4-4454-b662-d850d736291a 37808-986 HUMAN OTC DRUG Nighttime Sleep-Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 H E B DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 37808-987_c34b6325-e53d-462e-9596-d609ef6fe26f 37808-987 HUMAN OTC DRUG cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20060921 OTC MONOGRAPH FINAL part341 H E B BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 37808-994_2556824a-fe6b-4923-b1a3-159cb98dfc4b 37808-994 HUMAN OTC DRUG day time Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20110727 OTC MONOGRAPH FINAL part341 H E B ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 37835-003_ac15fb6d-ac8b-43e4-a371-6907b9e9e676 37835-003 HUMAN OTC DRUG Antiseptic Rinse Spring Mint Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20100810 OTC MONOGRAPH NOT FINAL part356 Bi-Mart EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 37835-318_71ce2611-fe75-486b-8e17-45275ad0904d 37835-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20100825 OTC MONOGRAPH NOT FINAL part356 Bi-Mart EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 37835-695_328fd31e-e715-4aa5-a0a0-ebe64f21d8d6 37835-695 HUMAN OTC DRUG DAYTIME COLD AND FLU Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20180111 OTC MONOGRAPH FINAL part341 Bi-Mart ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20191231 37835-891_60e028f0-515f-4fa7-e053-2991aa0a1e11 37835-891 HUMAN OTC DRUG Omeprazole Magnesium OMEPRAZOLE MAGNESIUM CAPSULE ORAL 20151125 ANDA ANDA078878 Bi-Mart OMEPRAZOLE MAGNESIUM 20.6 mg/1 N 20181231 37835-952_1eda2750-340e-4f80-a109-575111eab0a4 37835-952 HUMAN OTC DRUG NIGHTTIME COLD AND FLU Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate LIQUID ORAL 20180111 OTC MONOGRAPH FINAL part341 Bi-Mart ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20191231 37945-212_3a477714-6ff4-62aa-e054-00144ff8d46c 37945-212 HUMAN OTC DRUG Burn Cream tetracaine CREAM TOPICAL 20160819 OTC MONOGRAPH NOT FINAL part348 Bio-Medical & Pharmaceutical Manufacturing Corporation TETRACAINE 10 mg/mL N 20181231 37945-718_20fdfc2a-3217-69f7-e054-00144ff8d46c 37945-718 HUMAN OTC DRUG ANTIMICROBIAL FOAMING SANITIZER Benzethonium chloride liquid LIQUID TOPICAL 20151009 OTC MONOGRAPH NOT FINAL part333A Bio-Medical & Pharmaceutical Manufacturing Corporation BENZETHONIUM CHLORIDE .2 g/100g N 20181231 37945-860_0eaeb9e6-4efa-2b1e-e054-00144ff8d46c 37945-860 HUMAN OTC DRUG Pro-Tect Sunscreen for Professionals SPF 30 Meradimate, Octinoxate, Octisalate, Oxybenzone LOTION CUTANEOUS 19801101 OTC MONOGRAPH NOT FINAL part352 Bio-Medical & Pharmaceutical Manufacturing Corporation MERADIMATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 50 mg/g; mg/g; mg/g; mg/g N 20181231 37945-860_21fe4f99-a30d-3a7c-e054-00144ff88e88 37945-860 HUMAN OTC DRUG Pro-Tect Sunscreen for Professionals Meradimate, Octinoxate, Octisalate, Oxybenzone LOTION CUTANEOUS 20150515 OTC MONOGRAPH NOT FINAL part352 Bio-Medical & Pharmaceutical Manufacturing Corporation OCTINOXATE; MERADIMATE; OXYBENZONE; OCTISALATE 75; 50; 50; 50 mg/g; mg/g; mg/g; mg/g N 20181231 37945-862_0eae8a83-5546-5611-e054-00144ff88e88 37945-862 HUMAN OTC DRUG Pro-Tect Sports Sunscreen SPF 20 Meradimate, Octinoxate, Octisalate, Oxybenzone LOTION CUTANEOUS 19871201 OTC MONOGRAPH NOT FINAL part352 Bio-Medical & Pharmaceutical Manufacturing Corporation MERADIMATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 30 mg/g; mg/g; mg/g; mg/g N 20181231 37945-862_16994959-cadf-06de-e054-00144ff88e88 37945-862 HUMAN OTC DRUG Pro-Tect Sports Sunscreen Meradimate, Octinoxate, Octisalate, Oxybenzone LOTION CUTANEOUS 20150527 OTC MONOGRAPH NOT FINAL part352 Bio-Medical & Pharmaceutical Manufacturing Corporation OCTINOXATE; MERADIMATE; OXYBENZONE; OCTISALATE 75; 50; 30; 50 mg/g; mg/g; mg/g; mg/g N 20181231 37945-868_0eae8a83-5536-5611-e054-00144ff88e88 37945-868 HUMAN OTC DRUG Pro-Tect Everyday Sunscreen SPF 15 Octinoxate, Octisalate, Padimate O LOTION TOPICAL 19871201 OTC MONOGRAPH NOT FINAL part352 Bio-Medical & Pharmaceutical Manufacturing Corporation OCTINOXATE; OXYBENZONE; PADIMATE O 75; 20; 50 mg/g; mg/g; mg/g N 20181231 37945-868_1a3b3924-c01c-01da-e054-00144ff88e88 37945-868 HUMAN OTC DRUG PRO-TECT EVERYDAY SUNSCREEN SPF 15 Octinoxate, Octisalate, Padimate O LOTION TOPICAL 20150720 OTC MONOGRAPH NOT FINAL part352 Bio-Medical & Pharmaceutical Manufacturing Corporation OCTINOXATE; OXYBENZONE; PADIMATE O 75; 20; 50 mg/g; mg/g; mg/g N 20181231 37945-870_060e341a-c8fd-3746-e054-00144ff8d46c 37945-870 HUMAN OTC DRUG Kleer-Plex Foaming Acne Clarifier Salicylic Acid LIQUID TOPICAL 20141022 OTC MONOGRAPH FINAL part333D Bio-Medical & Pharmaceutical Manufacturing Corporation SALICYLIC ACID 20 mg/mL N 20181231 37945-874_060e341a-c8ef-3746-e054-00144ff8d46c 37945-874 HUMAN OTC DRUG Kleer-Plex Penetrating Acne SALICYLIC ACID GEL TOPICAL 20141022 OTC MONOGRAPH FINAL part333D Bio-Medical & Pharmaceutical Manufacturing Corporation SALICYLIC ACID 20 mg/mL N 20181231 37945-876_25c82c9e-09aa-4486-8fa0-a9fb4cd494ba 37945-876 HUMAN OTC DRUG Kleer-Plex Advanced Acne Care System Salicylic Acid KIT 20141103 OTC MONOGRAPH FINAL part333D Bio-Medical & Pharmaceutical Manufacturing Corporation N 20181231 37945-894_060e3c63-afdb-11c3-e054-00144ff88e88 37945-894 HUMAN OTC DRUG Kleer-Plex Targeted Acne Pen Salicylic Acid GEL TOPICAL 20141022 OTC MONOGRAPH FINAL part333D Bio-Medical & Pharmaceutical Manufacturing Corporation SALICYLIC ACID 20 mg/mL N 20181231 37945-902_217689d3-d23b-5a7a-e054-00144ff8d46c 37945-902 HUMAN OTC DRUG ANTIMICROBIAL FACE BODY WASH Benzethonium chloride liquid LIQUID TOPICAL 20151009 OTC MONOGRAPH NOT FINAL part333A Bio-Medical & Pharmaceutical Manufacturing Corporation BENZETHONIUM CHLORIDE .2 g/100g N 20181231 37945-908_2fc20e9c-c95b-6a41-e054-00144ff8d46c 37945-908 HUMAN OTC DRUG Fungistat Max Clotrimazole Transdermal Liquid LIQUID TOPICAL 20160412 OTC MONOGRAPH FINAL part333C Bio-Medical & Pharmaceutical Manufacturing Corporation CLOTRIMAZOLE 10 mg/mL E 20171231 37945-910_2fff1c7e-5670-4ccf-e054-00144ff88e88 37945-910 HUMAN OTC DRUG Fungistat Max clotrimazole LIQUID TOPICAL 20160414 OTC MONOGRAPH FINAL part333C Bio-Medical & Pharmaceutical Manufacturing Corporation CLOTRIMAZOLE 10 mg/mL E 20171231 38142-1000_fad878f9-6ee9-4e63-b603-27329d5412b0 38142-1000 HUMAN OTC DRUG Paladin Diaper Rash Zinc Oxide OINTMENT TOPICAL 19740701 OTC MONOGRAPH FINAL part347 PAL MIDWEST LTD. ZINC OXIDE .08 g/56g N 20191231 38142-5000_a762859f-ce5d-4e54-89cd-ef5a37ca2d99 38142-5000 HUMAN OTC DRUG Palomar E Skin Rash Zinc Oxide OINTMENT TOPICAL 19740701 OTC MONOGRAPH FINAL part347 PAL MIDWEST LTD. ZINC OXIDE .08 g/56g N 20191231 38176-001_33d7fbf2-ce2e-2153-e054-00144ff88e88 38176-001 HUMAN OTC DRUG Lip Healer SPF 15 OXYBENZONE, PADIMATE O STICK TOPICAL 20160526 OTC MONOGRAPH NOT FINAL part352 Continental Vitamin Company Inc OXYBENZONE; PADIMATE O 30; 70 mg/g; mg/g N 20181231 38739-200_6d30f862-0443-4cb7-be13-57ef9e26ed08 38739-200 HUMAN PRESCRIPTION DRUG SYMJEPI Epinephrine INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20171115 NDA NDA207534 Adamis Pharmaceuticals Corporation EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 38755-0111_42ba124d-14a1-4ad0-8c24-6995235cd0d6 38755-0111 HUMAN OTC DRUG Oily Hair Dandruff Zerran International Zinc Pyrithione CREAM TOPICAL 20100715 OTC MONOGRAPH FINAL part358H Zerran International Corporation PYRITHIONE ZINC 1 mL/100mL E 20171231 39313-001_310b556b-0fea-4da6-bb43-a83a617867ab 39313-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19720101 NDA NDA205849 Middlesex Welding Sales Co, Inc. OXYGEN 99 L/100L N 20181231 39313-006_b21a791b-a54e-4028-852d-4fff07d6fb3a 39313-006 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19720101 NDA NDA205850 Middlesex Welding Sales Co, Inc. NITROGEN 99 L/100L N 20181231 39328-044_10d061b1-6692-4392-a4b4-e883b3cfd53b 39328-044 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride SOLUTION ORAL 20170101 ANDA ANDA204823 Patrin Pharma CYPROHEPTADINE HYDROCHLORIDE 2 mg/5mL N 20181231 39328-047_44e1d713-12e4-4050-8968-49fbdedd32dd 39328-047 HUMAN PRESCRIPTION DRUG Hyoscyamine Hyoscyamine Sulfate LIQUID ORAL 20110904 UNAPPROVED DRUG OTHER Patrin Pharma HYOSCYAMINE SULFATE .125 mg/mL N 20181231 39328-048_e4d3bee8-e9c8-4e76-86aa-3bd6256292c5 39328-048 HUMAN PRESCRIPTION DRUG Hyoscyamine Hyoscyamine Sulfate LIQUID ORAL 20110904 UNAPPROVED DRUG OTHER Patrin Pharma HYOSCYAMINE SULFATE .125 mg/5mL N 20181231 39328-106_59c5c1a4-3f42-441a-b842-903f9bab346f 39328-106 HUMAN PRESCRIPTION DRUG Prenatal Vitamins Plus Low Iron Prenatal with Ferrous Fum and Folic Acid TABLET ORAL 20130401 UNAPPROVED DRUG OTHER Patrin Pharma, Inc. VITAMIN A ACETATE; BETA CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; IRON; ZINC; COPPER 3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 39328-541_bf6ed2f7-38cc-41fa-8889-c46f40342fb5 39328-541 HUMAN PRESCRIPTION DRUG Lactulose Lactulose LIQUID ORAL; RECTAL 20160901 ANDA ANDA203762 Patrin Pharma LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 39328-551_7bfec71d-e481-4e5b-a1ff-ccfbe687a86d 39328-551 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride LIQUID ORAL 20160601 ANDA ANDA205446 Patrin Pharma MEMANTINE HYDROCHLORIDE 2 mg/mL NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 39338-1072_47f18e24-789c-4b3e-b116-4e797f5c143a 39338-1072 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070717 UNAPPROVED MEDICAL GAS Yosemite Medical Supply OXYGEN 99 L/100L E 20171231 39765-001_7b282bd0-b2dd-4ebc-b15b-3f12f79342bb 39765-001 HUMAN OTC DRUG Heeltastic DIMETHICONE AND TOLNAFTATE STICK TOPICAL 20090630 OTC MONOGRAPH FINAL part333C Neutraderm, Inc. DIMETHICONE; TOLNAFTATE 1; 1 g/100g; g/100g N 20181231 39765-002_4bbac0f2-2a4b-420e-b548-d5b2dd88635b 39765-002 HUMAN OTC DRUG HQRA-OTC Hydroquinone CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part358A Neutraderm Inc HYDROQUINONE 2 g/100g N 20181231 39765-003_f05d6c34-32f4-47fe-b226-345ec73e9d0b 39765-003 HUMAN OTC DRUG SPF-60 Octinoxate, Oxybenzone, Octocrylene, Avobenzone CREAM TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part352 Neutraderm, Inc. OCTINOXATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 5; 5; 4; 3 g/100g; g/100g; g/100g; g/100g N 20181231 39765-004_8c5d72ee-ff70-4315-83b6-2ddf0b9852b3 39765-004 HUMAN OTC DRUG Daily Wear Moisturizer SPF-20 Octinoxate, Octocrylene, Oxybenzone, Avobenzone CREAM TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Neutraderm, Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 6; 5; 3; 2.5 g/100g; g/100g; g/100g; g/100g N 20181231 39765-005_a3418eb4-456f-4b65-95f4-ca9df5a5fbd4 39765-005 HUMAN OTC DRUG Acne Control Serum Benzoyl Peroxide GEL TOPICAL 20100701 OTC MONOGRAPH FINAL part333D Neutraderm, Inc. BENZOYL PEROXIDE 5 mL/100mL N 20181231 39765-007_4effb961-86f9-4b5b-886c-59bf59b2bedf 39765-007 HUMAN OTC DRUG Clarifying Cleanser Salicylic Acid LIQUID TOPICAL 20100801 OTC MONOGRAPH FINAL part333D Neutraderm, Inc. SALICYLIC ACID 2 mL/100mL N 20181231 39822-0123_fbab3d4f-cb10-44b1-9374-6abb15f3ccac 39822-0123 HUMAN PRESCRIPTION DRUG Piperacillin, Tazobactam Piperacillin, Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170201 ANDA ANDA207847 X-GEN Pharmaceuticals, Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 39822-0125_fbab3d4f-cb10-44b1-9374-6abb15f3ccac 39822-0125 HUMAN PRESCRIPTION DRUG Piperacillin, Tazobactam Piperacillin, Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170201 ANDA ANDA207847 X-GEN Pharmaceuticals, Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 39822-0127_fbab3d4f-cb10-44b1-9374-6abb15f3ccac 39822-0127 HUMAN PRESCRIPTION DRUG Piperacillin, Tazobactam Piperacillin, Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170201 ANDA ANDA207847 X-GEN Pharmaceuticals, Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 39822-0139_c055e19b-2e39-42ad-a421-2625a4aac5a5 39822-0139 HUMAN PRESCRIPTION DRUG Piperacillin, Tazobactam Piperacillin, Tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170201 ANDA ANDA207848 X-GEN Pharmaceuticals, Inc. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 36; 4.5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 39822-0151_3788b13f-e7fb-4bd3-876d-259b7ea27330 39822-0151 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium INJECTION, SOLUTION INTRAVENOUS 20050817 ANDA ANDA076923 X-GEN Pharmaceuticals, Inc. LIOTHYRONINE SODIUM 10 ug/mL l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 39822-0166_6e0e193e-e063-4340-8de5-9940d4888fef 39822-0166 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 19940930 ANDA ANDA063000 X-GEN Pharmaceuticals, Inc. POLYMYXIN B SULFATE 500000 [USP'U]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 39822-0170_5acacba1-5f1f-46ab-ba40-e13d90d5d7da 39822-0170 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20140115 ANDA ANDA202766 X-GEN Pharmaceuticals, Inc. POLYMYXIN B SULFATE 500000 [USP'U]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 39822-0171_b519442d-f8d6-4c0e-bf4a-824c77e398b4 39822-0171 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140425 ANDA ANDA202766 X-GEN Pharmaceuticals, Inc. POLYMYXIN B SULFATE 500000 [USP'U]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 39822-0190_badd2e54-8c04-482b-aa7f-9d124575ba8d 39822-0190 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081210 ANDA ANDA040784 X-GEN Pharmaceuticals, Inc. ACETAZOLAMIDE SODIUM 500 mg/5mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 39822-0191_8f8499bd-b08c-43a2-8699-8b82ba014ce5 39822-0191 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20131210 ANDA ANDA040784 X-GEN Pharmaceuticals, Inc. ACETAZOLAMIDE SODIUM 500 mg/5mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 39822-0205_43e9cfd8-26e6-4d38-a41e-de39b9329b8a 39822-0205 HUMAN PRESCRIPTION DRUG PANCRELIPASE pancrelipase CAPSULE, DELAYED RELEASE ORAL 20090922 20180331 NDA AUTHORIZED GENERIC NDA022210 X-GEN Pharmaceuticals, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 5000; 17000; 27000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 39822-0277_a362920a-a6ac-4ea3-a4b0-a0c59f8b7548 39822-0277 HUMAN PRESCRIPTION DRUG BACiiM Bacitracin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 19970509 ANDA ANDA064153 X-GEN Pharmaceuticals, Inc. BACITRACIN 50000 [USP'U]/1 Decreased Cell Wall Synthesis & Repair [PE] N 20181231 39822-0278_be6f0d9b-e9ee-4d3c-b589-377461a7595e 39822-0278 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20151008 ANDA ANDA203177 X-GEN Pharmaceuticals, Inc. BACITRACIN 50000 [USP'U]/1 Decreased Cell Wall Synthesis & Repair [PE] N 20181231 39822-0310_a3e6f44d-a050-4926-ad2a-df873da8618f 39822-0310 HUMAN PRESCRIPTION DRUG Neomycin Sulfate Neomycin Sulfate TABLET ORAL 20100312 ANDA ANDA065220 X-GEN Pharmaceuticals, Inc. NEOMYCIN SULFATE 500 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 39822-0350_5ea7fe16-a790-42aa-ad0f-523a02981f2a 39822-0350 HUMAN PRESCRIPTION DRUG Lincomycin lincomycin hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL 20150705 ANDA ANDA201746 X-GEN Pharmaceuticals, Inc. LINCOMYCIN HYDROCHLORIDE 300 mg/mL N 20181231 39822-0353_5ea7fe16-a790-42aa-ad0f-523a02981f2a 39822-0353 HUMAN PRESCRIPTION DRUG Lincomycin lincomycin hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL 20150705 ANDA ANDA201746 X-GEN Pharmaceuticals, Inc. LINCOMYCIN HYDROCHLORIDE 300 mg/mL N 20181231 39822-0409_284f9119-9230-443d-be91-2ed6a7dbe355 39822-0409 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010817 ANDA ANDA065013 X-GEN Pharmaceuticals, Inc. TOBRAMYCIN SULFATE 1.2 g/30mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 39822-0412_f8ee4527-2516-45f2-bff9-c39989fd821a 39822-0412 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010817 ANDA ANDA065013 X-GEN Pharmaceuticals, Inc. TOBRAMYCIN SULFATE 1.2 g/30mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 39822-0500_df6c687a-1531-4aed-b72e-26b25fd6f5fe 39822-0500 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150629 ANDA ANDA203110 X-GEN Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 39822-0615_f9a2374c-cbaa-4607-a5a1-b64962940174 39822-0615 HUMAN PRESCRIPTION DRUG Colistimethate Colistimethate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110101 ANDA ANDA064216 X-GEN Pharmaceuticals, Inc. COLISTIMETHATE SODIUM 150 mg/2mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 39822-0617_cb66e68f-efc4-4279-a780-8e363253b25e 39822-0617 HUMAN PRESCRIPTION DRUG Colistimethate colistimethate sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20160701 ANDA ANDA205356 X-GEN Pharmaceuticals, Inc. COLISTIMETHATE 150 mg/2mL N 20191231 39822-0706_0709a8ef-213f-47e5-a325-36b60d47c47c 39822-0706 HUMAN PRESCRIPTION DRUG Streptomycin Streptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 19980630 ANDA ANDA064210 X-GEN Pharmaceuticals, Inc. STREPTOMYCIN SULFATE 1 g/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Antimycobacterial [EPC] N 20181231 39822-0710_a1ca3574-7f2f-4705-b355-6db7f4aef716 39822-0710 HUMAN PRESCRIPTION DRUG fomepizole fomepizole INJECTION, SOLUTION INTRAVENOUS 20071214 ANDA ANDA078368 X-GEN Pharmaceuticals FOMEPIZOLE 1 g/mL Antidote [EPC] N 20181231 39822-1000_01230b70-7866-4d50-baba-b9c22aae0241 39822-1000 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20120518 ANDA ANDA201580 X-GEN Pharmaceuticals, Inc. TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20191231 39822-1001_a4a744a9-ef18-4ed2-b896-f64f0fb99473 39822-1001 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20120518 ANDA ANDA201580 X-GEN Pharmaceuticals, Inc. TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 39822-1030_1c3d7ae0-7354-46cb-ac78-12e02d8cdd94 39822-1030 HUMAN PRESCRIPTION DRUG Ibuprofen Lysine Ibuprofen Lysine SOLUTION INTRAVENOUS 20160408 ANDA ANDA202402 X-GEN Pharmaceuticals, Inc. IBUPROFEN LYSINE 10 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 39822-1055_ecdad580-8983-4dea-b7df-8a652e4c9555 39822-1055 HUMAN PRESCRIPTION DRUG Amphotericin B Amphotericin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19920429 ANDA ANDA063206 X-GEN Pharmaceuticals, Inc. AMPHOTERICIN B 50 mg/10mL Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 39822-1077_6b6a6819-7d9e-4001-936b-ebe76b921eeb 39822-1077 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170309 NDA NDA208562 X-GEN Pharmaceuticals, Inc. VORICONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 39822-1201_74182c7d-8f18-4be4-a9ed-aaf3c420da1d 39822-1201 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates Neomycin and Polymyxin B Sulfates SOLUTION IRRIGATION 20060119 ANDA ANDA065106 X-GEN Pharmaceuticals, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE 40; 200000 mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 39822-1220_74182c7d-8f18-4be4-a9ed-aaf3c420da1d 39822-1220 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates Neomycin and Polymyxin B Sulfates SOLUTION IRRIGATION 20060131 ANDA ANDA065108 X-GEN Pharmaceuticals, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE 40; 200000 mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 39822-2000_c9dc05fc-0fca-4ebe-8101-3ce48404e1ec 39822-2000 HUMAN PRESCRIPTION DRUG Clonidine Clonidine INJECTION, SOLUTION EPIDURAL 20131029 ANDA ANDA203167 X-GEN Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 39822-2010_c9dc05fc-0fca-4ebe-8101-3ce48404e1ec 39822-2010 HUMAN PRESCRIPTION DRUG Clonidine Clonidine INJECTION, SOLUTION EPIDURAL 20131029 ANDA ANDA203167 X-GEN Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE 500 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 39822-2120_4a5a9859-ec00-45cc-831a-5c22e2074010 39822-2120 HUMAN PRESCRIPTION DRUG Docetaxel docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170417 ANDA ANDA206177 X-GEN Pharmaceuticals, Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 39822-2180_4a5a9859-ec00-45cc-831a-5c22e2074010 39822-2180 HUMAN PRESCRIPTION DRUG Docetaxel docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170417 ANDA ANDA206177 X-GEN Pharmaceuticals, Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 39822-2200_4a5a9859-ec00-45cc-831a-5c22e2074010 39822-2200 HUMAN PRESCRIPTION DRUG Docetaxel docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170417 ANDA ANDA206177 X-GEN Pharmaceuticals, Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 39822-3015_5b15e0c4-34ac-44f3-8ccb-d41f36ce06da 39822-3015 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20040830 ANDA ANDA065175 X-GEN Pharmaceuticals, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 39822-4000_20a6f7f3-eb26-44d7-af68-67f6bf8078ce 39822-4000 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20110805 ANDA ANDA091485 X-GEN Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/5mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 39822-4025_d00d9045-a85c-4afd-979c-363d43ee03c3 39822-4025 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140223 ANDA ANDA206039 X-GEN Pharmaceuticals, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 39822-4050_492a8728-d60f-41ea-bedd-ead7375f3ad5 39822-4050 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110502 ANDA ANDA040573 X-GEN Pharmaceuticals, Inc. PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 39822-4200_21c3487f-daae-4141-8307-0df832bc25c8 39822-4200 HUMAN PRESCRIPTION DRUG rocuronium bromide rocuronium bromide SOLUTION INTRAVENOUS 20121201 ANDA ANDA091115 X-GEN Pharmaceuticals, Inc. ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20191231 39822-5525_7c157929-9e5a-48e3-841a-59a919eba890 39822-5525 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150130 ANDA ANDA040737 X-GEN Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 39822-5550_8dc3abce-ebde-4042-917e-5ce9973f18c9 39822-5550 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150130 ANDA ANDA040737 X-GEN Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 39822-9900_b6c2d3ed-42b6-4cb0-94b3-0a423572578c 39822-9900 HUMAN PRESCRIPTION DRUG Ammonia Inhalants Ammonia Inhalants INHALANT RESPIRATORY (INHALATION) 19760214 UNAPPROVED DRUG OTHER X-GEN Pharmaceuticals, Inc. AMMONIA .045 g/.3mL N 20181231 39892-0100_4bbaac53-82b7-6e94-e054-00144ff8d46c 39892-0100 HUMAN OTC DRUG MediChoice Antiseptic Isopropyl Alcohol Prep Pads ISOPROPYL ALCOHOL SWAB TOPICAL 20120920 OTC MONOGRAPH NOT FINAL part333A Owens & Minor, Inc ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 39892-0301_4b7e49f9-bec5-4953-e054-00144ff8d46c 39892-0301 HUMAN OTC DRUG MediChoice BZK Antiseptic Towelette BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130619 OTC MONOGRAPH NOT FINAL part333A Owens and Minor BENZALKONIUM CHLORIDE .13 mg/100mg N 20181231 39892-0302_4b7e4d29-1e68-3854-e054-00144ff8d46c 39892-0302 HUMAN OTC DRUG MediChoice Cleansing Towelette BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141111 OTC MONOGRAPH NOT FINAL part333A Owens and Minor BENZALKONIUM CHLORIDE .13 mg/100mg N 20181231 39892-0303_4b7e4edd-a431-5fd6-e054-00144ff88e88 39892-0303 HUMAN OTC DRUG MediChoice OB Cleansing Towelette BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141111 OTC MONOGRAPH NOT FINAL part333A Owens and Minor BENZALKONIUM CHLORIDE .13 mg/100mg N 20181231 39892-0304_618470c1-de1c-9868-e053-2a91aa0a6a8d 39892-0304 HUMAN OTC DRUG MediChoice BZK Antiseptic BENZALKONIUM CHLORIDE CLOTH TOPICAL 20170829 OTC MONOGRAPH NOT FINAL part333A Owens & Minor Distribution, Inc. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 39892-0305_57fae1e5-e19f-5dfa-e053-2991aa0aed89 39892-0305 HUMAN OTC DRUG MediChoice Cleansing BENZALKONIUM CHLORIDE CLOTH TOPICAL 20170829 OTC MONOGRAPH NOT FINAL part333A Owens & Minor Distribution, Inc. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 39892-0306_57fae1e5-e1ad-5dfa-e053-2991aa0aed89 39892-0306 HUMAN OTC DRUG MediChoice OB Cleansing BENZALKONIUM CHLORIDE CLOTH TOPICAL 20170829 OTC MONOGRAPH NOT FINAL part333A Owens & Minor Distribution, Inc. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 39892-0601_931fe295-4949-43af-8c8d-f5a9d0239222 39892-0601 HUMAN OTC DRUG MEDICHOICE ANTICAVITY FLUORIDE SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20100518 OTC MONOGRAPH FINAL part355 Owens and Minor SODIUM FLUORIDE 22 g/100g E 20171231 39892-0602_2a3293c5-95af-4b88-a4d0-cf0a7757825a 39892-0602 HUMAN OTC DRUG MediChoice Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20130301 OTC MONOGRAPH FINAL part355 Owens & Minor SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 39892-0603_cba4c13a-511a-4e4b-b0ef-a7d212d4f29c 39892-0603 HUMAN OTC DRUG MediChoice Premium Anticavity Fluoride SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130301 OTC MONOGRAPH FINAL part355 Owens & Minor SODIUM FLUORIDE 2.43 mg/g N 20181231 39892-0801_5f139f06-852a-a5fe-e053-2a91aa0acb3e 39892-0801 HUMAN OTC DRUG MediChoice Alcohol Swabstick ISOPROPYL ALCOHOL SWAB TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part333A Owens & Minor, Inc ISOPROPYL ALCOHOL 70 g/100g N 20181231 39892-0802_c42a570f-0d99-4464-945d-213e6db68567 39892-0802 HUMAN OTC DRUG MediChoice PVP Swabsticks POVIDONE-IODINE SWAB TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part333E Owens and Minor POVIDONE-IODINE 10 g/100g N 20181231 39892-0803_5f13901f-4393-219d-e053-2991aa0adf7e 39892-0803 HUMAN OTC DRUG MediChoice Alcohol Swabstick ISOPROPYL ALCOHOL SWAB TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part333A Owens & Minor, Inc ISOPROPYL ALCOHOL 70 g/100g N 20181231 39892-0804_c435faab-eeb7-4604-8e97-b82455c48429 39892-0804 HUMAN OTC DRUG MediChoice PVP Swabsticks POVIDONE-IODINE SWAB TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part333E Owens and Minor POVIDONE-IODINE 10 g/100g N 20181231 39892-0807_d7573b66-2a27-4cb6-a07f-245209c1c53d 39892-0807 HUMAN OTC DRUG Roll-On Antiperspirant Deodorant - Scented ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20150924 OTC MONOGRAPH FINAL part350 OWENS & MINOR ALUMINUM CHLOROHYDRATE 10 mg/100mL N 20181231 39892-0810_5e88064f-c74f-cdcc-e053-2a91aa0a032c 39892-0810 HUMAN OTC DRUG MediChoice Bacitracin Bacitracin OINTMENT TOPICAL 20150326 OTC MONOGRAPH FINAL part333B Owens & Minor Inc BACITRACIN 500 [iU]/g N 20181231 39892-0811_589eb7d5-24bb-5e1e-e053-2a91aa0a3d49 39892-0811 HUMAN OTC DRUG MediChoice PVP POVIDONE-IODINE SWAB TOPICAL 20170829 OTC MONOGRAPH NOT FINAL part333E Owens & Minor Distribution, Inc. POVIDONE-IODINE 10 g/100g N 20181231 39892-0812_58af3209-3dca-11cf-e053-2a91aa0aae30 39892-0812 HUMAN OTC DRUG MediChoice PVP POVIDONE-IODINE SWAB TOPICAL 20170829 OTC MONOGRAPH NOT FINAL part333E Owens & Minor Distribution, Inc. POVIDONE-IODINE 10 g/100g N 20181231 39892-0830_13400f6d-ffcd-4d88-833c-916e897adcf2 39892-0830 HUMAN OTC DRUG MediChoice Triple Antibiotic Bacitracin OINTMENT TOPICAL 20150327 OTC MONOGRAPH FINAL part333B Owens & Minor Inc. BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 39892-0900_618464e6-e080-859a-e053-2a91aa0ac930 39892-0900 HUMAN OTC DRUG MediChoice Lip Balm SPF 15 OXYBENZONE, OCTINOXATE LIPSTICK TOPICAL 20141222 OTC MONOGRAPH NOT FINAL part352 Owens & Minor Inc. OXYBENZONE; OCTINOXATE 3; 7.5 g/100g; g/100g N 20191231 40002-002_331f6703-c665-4168-ae6b-4e38d58905f9 40002-002 HUMAN OTC DRUG Tolnaftate D Tolnaftate CREAM TOPICAL 20110815 OTC MONOGRAPH FINAL part333C NexMed (USA), Inc. TOLNAFTATE 1 g/100g E 20171231 40002-003_5551bb51-cbd5-4ce2-94f5-15433eb899bc 40002-003 HUMAN OTC DRUG Hydrocortisone D Hydrocortisone CREAM TOPICAL 20110819 OTC MONOGRAPH NOT FINAL part348 NexMed (USA), Inc. HYDROCORTISONE 1 g/100g E 20171231 40002-004_3846ecd5-9298-40e6-84d4-e1ef8815b86e 40002-004 HUMAN OTC DRUG Diphenhydramine D Diphenhydramine HCl, Zinc Acetate CREAM TOPICAL 20110829 OTC MONOGRAPH NOT FINAL part348 NexMed (USA), Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g E 20171231 40028-511_fbb8396b-f6fb-47c3-8856-8283a4df3cb7 40028-511 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION, SOLUTION INTRAVENOUS 20080729 ANDA ANDA079086 PETNET Solutions, Inc. FLUDEOXYGLUCOSE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 40028-512_7d4026d0-ea6b-4c45-92e9-1c641a2473c2 40028-512 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 Sodium Fluoride F 18 INJECTION, SOLUTION INTRAVENOUS 20110126 ANDA ANDA203890 PETNET Solutions, Inc. SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 40028-513_b3e5a0c4-4071-443b-b9a1-f69e5e30db35 40028-513 HUMAN PRESCRIPTION DRUG Ammonia N 13 Ammonia N-13 INJECTION INTRAVENOUS 20070823 ANDA ANDA204510 PETNET Solutions, Inc. AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 40032-016_878c2746-64ac-4cf5-a8d6-25b2799b5891 40032-016 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION TOPICAL 20151209 ANDA ANDA205878 Novel Laboratories, Inc. DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 40032-022_86a99f2d-7af1-4fe5-864d-a908cf22a0c8 40032-022 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET ORAL 20160822 ANDA ANDA207526 Novel Laboratories, Inc. LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 40032-024_e89ba1da-1104-4402-b0c5-e5afe8373eea 40032-024 HUMAN PRESCRIPTION DRUG Desoximetasone desoximetasone OINTMENT TOPICAL 20160510 ANDA ANDA206792 Novel Laboratories, Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 40032-026_09d4aa56-fa9a-4697-aeab-87ba2f0cca92 40032-026 HUMAN PRESCRIPTION DRUG fluocinonide fluocinonide SOLUTION TOPICAL 20170721 ANDA ANDA206003 Novel Laboratories, Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 40032-028_47d04010-3bdd-4720-82bb-54db608ded8a 40032-028 HUMAN PRESCRIPTION DRUG clobetasol propionate clobetasol propionate SOLUTION TOPICAL 20151123 ANDA ANDA206075 Novel Laboratories, Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 40032-030_ef387122-eb08-446d-a299-29c8179c54f1 40032-030 HUMAN PRESCRIPTION DRUG Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Monobasic Sodium Phosphate and Dibasic Sodium Phosphate TABLET ORAL 20120120 ANDA ANDA079247 Novel Laboratories, Inc. SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS 1.105; .398 g/1; g/1 Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 40032-034_709f0134-b44a-4bed-9353-e6f0e5583c9e 40032-034 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET ORAL 20170213 ANDA ANDA207285 Novel Laboratories, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 40032-038_58634583-039c-4379-8198-5be323d6adde 40032-038 HUMAN PRESCRIPTION DRUG voriconazole voriconazole SUSPENSION ORAL 20160601 ANDA ANDA206799 Novel Laboratories, Inc. VORICONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 40032-050_0cb089b8-0127-4f5f-8b8d-77bc93409747 40032-050 HUMAN PRESCRIPTION DRUG Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate POWDER, FOR SOLUTION ORAL 20090528 ANDA ANDA090019 Novel Laboratories, Inc. POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE 420; 11.2; 5.72; 1.48 g/438.4g; g/438.4g; g/438.4g; g/438.4g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 40032-060_b76cfbc2-2ecf-478c-adae-a141ec93553d 40032-060 HUMAN PRESCRIPTION DRUG Polyethylene Glycol-3350 and Electrolytes with Flavor Pack Polyethylene Glycol-3350 and Electrolytes with Flavor Pack POWDER, FOR SOLUTION ORAL 20090601 ANDA ANDA090186 Novel Laboratories, Inc. POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 240; 5.84; 6.72; 2.98; 22.72 g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 40032-080_fe621d98-188e-42fe-8ea6-3bc3467f9e49 40032-080 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA202829 Novel Laboratories, Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 40032-081_fe621d98-188e-42fe-8ea6-3bc3467f9e49 40032-081 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA202829 Novel Laboratories, Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 40032-082_fe621d98-188e-42fe-8ea6-3bc3467f9e49 40032-082 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA202829 Novel Laboratories, Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 40032-083_fe621d98-188e-42fe-8ea6-3bc3467f9e49 40032-083 HUMAN PRESCRIPTION DRUG AMLODIPINE and VALSARTAN AMLODIPINE and VALSARTAN TABLET ORAL 20150330 ANDA ANDA202829 Novel Laboratories, Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 40032-088_ad9a6d73-7ea5-449e-82a1-10e915c027eb 40032-088 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20160524 ANDA ANDA207371 Novel Laboratories, Inc. VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 40032-089_ad9a6d73-7ea5-449e-82a1-10e915c027eb 40032-089 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20160524 ANDA ANDA207371 Novel Laboratories, Inc. VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 40032-090_f2f502c8-49f4-4552-86a9-1c8a0466dfbe 40032-090 HUMAN PRESCRIPTION DRUG POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES POWDER, FOR SOLUTION ORAL 20090601 ANDA ANDA090231 Novel Laboratories, Inc. POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 236; 22.74; 6.74; 5.86; 2.97 g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 40032-095_9eb4edbd-dc0b-48cc-b088-6d1871d61157 40032-095 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 20170731 ANDA ANDA207538 Novel Laboratories, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 40032-118_24b4ab14-517d-4281-bc3b-161b4e0b8e0b 40032-118 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide TABLET ORAL 20140923 ANDA ANDA091528 Novel Laboratories, Inc. HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 40032-120_8bfc2252-e630-499c-9a04-d408bf9f9b7e 40032-120 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20120622 ANDA ANDA071457 Novel Laboratories, Inc. TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 40032-121_8bfc2252-e630-499c-9a04-d408bf9f9b7e 40032-121 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20091001 ANDA ANDA071456 Novel Laboratories, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 40032-122_8bfc2252-e630-499c-9a04-d408bf9f9b7e 40032-122 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20120622 ANDA ANDA071457 Novel Laboratories, Inc. TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 40032-123_8bfc2252-e630-499c-9a04-d408bf9f9b7e 40032-123 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20091001 ANDA ANDA071457 Novel Laboratories, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 40032-140_afedb0c3-649c-4df6-b037-b6bc71946a56 40032-140 HUMAN PRESCRIPTION DRUG Methylergonovine Maleate Methylergonovine Maleate TABLET ORAL 20110615 ANDA ANDA091577 Novel Laboratories, Inc. METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20191231 40032-160_88fa5005-7472-466b-bfe9-25261821eaee 40032-160 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 Novel Laboratories, Inc. MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20191231 40032-161_88fa5005-7472-466b-bfe9-25261821eaee 40032-161 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 Novel Laboratories, Inc. MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20191231 40032-312_6c926ac6-90c6-4752-af3a-ddd0963137a6 40032-312 HUMAN OTC DRUG Polyethylene Glycol-3350 Polyethylene Glycol-3350 POWDER, FOR SOLUTION ORAL 20091006 ANDA ANDA091077 Novel Laboratories, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 40032-330_63ba2637-37db-4f1e-b488-6e53466a5028 40032-330 HUMAN PRESCRIPTION DRUG Trimethoprim Trimethoprim TABLET ORAL 20140304 ANDA ANDA091437 Novel Laboratories, Inc. TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 40032-351_d589d665-b189-474f-bc77-7f1554a46745 40032-351 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161114 ANDA ANDA206142 Novel Laboratories, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 40032-352_d589d665-b189-474f-bc77-7f1554a46745 40032-352 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161114 ANDA ANDA206142 Novel Laboratories, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 40032-353_d589d665-b189-474f-bc77-7f1554a46745 40032-353 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161114 ANDA ANDA206142 Novel Laboratories, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 40032-356_c6dbd7c0-6b0c-43cb-b99d-e103ed421e4d 40032-356 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161201 ANDA ANDA206245 Novel Laboratories, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 40032-357_c6dbd7c0-6b0c-43cb-b99d-e103ed421e4d 40032-357 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161201 ANDA ANDA206245 Novel Laboratories, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 40032-358_c6dbd7c0-6b0c-43cb-b99d-e103ed421e4d 40032-358 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161201 ANDA ANDA206245 Novel Laboratories, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 40032-360_c3334c58-bba0-44a7-8d65-51ac865dd21d 40032-360 HUMAN PRESCRIPTION DRUG Phenelzine Sulfate Phenelzine Sulfate TABLET ORAL 20110214 ANDA ANDA200181 Novel Laboratories, Inc. PHENELZINE SULFATE 15 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 40032-430_ad0bb619-443b-477b-a019-77c8c6720720 40032-430 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20170612 ANDA ANDA204021 Novel Laboratories, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 40032-431_ad0bb619-443b-477b-a019-77c8c6720720 40032-431 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20170612 ANDA ANDA204021 Novel Laboratories, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 40032-432_ad0bb619-443b-477b-a019-77c8c6720720 40032-432 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20170612 ANDA ANDA204021 Novel Laboratories, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 40032-433_ad0bb619-443b-477b-a019-77c8c6720720 40032-433 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20170612 ANDA ANDA204021 Novel Laboratories, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 40032-434_ad0bb619-443b-477b-a019-77c8c6720720 40032-434 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20170612 ANDA ANDA204021 Novel Laboratories, Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 40032-450_f62f5875-c0f1-4892-95c4-a811d8b6f1de 40032-450 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin SUSPENSION ORAL 20140908 ANDA ANDA201693 Novel Laboratories, Inc. NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 40032-500_d476f4fa-86f9-45f0-bfb0-64b3e34a6d83 40032-500 HUMAN PRESCRIPTION DRUG Famotidine Famotidine FOR SUSPENSION ORAL 20121217 ANDA ANDA201695 Novel Laboratories, Inc. FAMOTIDINE 40 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 40032-540_4073de0a-5149-4619-a254-67715296b8fc 40032-540 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20151216 ANDA ANDA203602 Novel Laboratories, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 40032-541_4073de0a-5149-4619-a254-67715296b8fc 40032-541 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20151216 ANDA ANDA203602 Novel Laboratories, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 40032-542_4073de0a-5149-4619-a254-67715296b8fc 40032-542 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20151216 ANDA ANDA203602 Novel Laboratories, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 40032-543_4073de0a-5149-4619-a254-67715296b8fc 40032-543 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20151216 ANDA ANDA203602 Novel Laboratories, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 40032-544_4073de0a-5149-4619-a254-67715296b8fc 40032-544 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20151216 ANDA ANDA203602 Novel Laboratories, Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 40032-550_530af487-7e0b-4ad5-a45b-3f7d9b1b71ae 40032-550 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20120430 ANDA ANDA202044 Novel Laboratories, Inc. TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 40032-551_530af487-7e0b-4ad5-a45b-3f7d9b1b71ae 40032-551 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20120430 ANDA ANDA202044 Novel Laboratories, Inc. TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 40032-570_2abc1e6e-0247-4027-832b-6e5fcac91468 40032-570 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, CHEWABLE ORAL 20150225 ANDA ANDA204115 Novel Laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 40032-571_2abc1e6e-0247-4027-832b-6e5fcac91468 40032-571 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, CHEWABLE ORAL 20150225 ANDA ANDA204115 Novel Laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 40032-572_2abc1e6e-0247-4027-832b-6e5fcac91468 40032-572 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, CHEWABLE ORAL 20150225 ANDA ANDA204115 Novel Laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 40032-573_07e58ef7-4278-4994-a6f3-ac37d27c3655 40032-573 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20151113 ANDA ANDA207884 Novel Laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 40032-574_07e58ef7-4278-4994-a6f3-ac37d27c3655 40032-574 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20151113 ANDA ANDA207884 Novel Laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 40032-575_07e58ef7-4278-4994-a6f3-ac37d27c3655 40032-575 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20151113 ANDA ANDA207884 Novel Laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 40032-580_6560c273-018b-4668-8c95-f5fd1fe77998 40032-580 HUMAN PRESCRIPTION DRUG METOCLOPRAMIDE hydrochloride Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20140815 ANDA ANDA202191 Novel Laboratories, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 40032-581_6560c273-018b-4668-8c95-f5fd1fe77998 40032-581 HUMAN PRESCRIPTION DRUG METOCLOPRAMIDE hydrochloride Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20140815 ANDA ANDA202191 Novel Laboratories, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 40032-620_2d791cf6-fae5-4146-9cf0-e8a597ecd1bb 40032-620 HUMAN PRESCRIPTION DRUG Levonorgestrel Levonorgestrel TABLET ORAL 20130222 ANDA ANDA202508 Novel Laboratories, Inc. LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] E 20171231 40032-622_af913ba6-b143-43c5-86fc-a36fd494b29d 40032-622 HUMAN PRESCRIPTION DRUG Levonorgestrel Levonorgestrel TABLET ORAL 20130215 ANDA ANDA202508 Novel Laboratories, Inc. LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] N 20181231 40032-652_343bfbf8-1a44-454f-8feb-d2a2b4461ea0 40032-652 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20160308 ANDA ANDA206793 Novel Laboratories, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 40032-653_343bfbf8-1a44-454f-8feb-d2a2b4461ea0 40032-653 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20160308 ANDA ANDA206793 Novel Laboratories, Inc. CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 40032-761_8803cf1f-08be-409e-b37e-c83a0313fcbc 40032-761 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET SUBLINGUAL 20160322 ANDA ANDA204299 Novel Laboratories, Inc. ZOLPIDEM TARTRATE 3.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 40032-762_8803cf1f-08be-409e-b37e-c83a0313fcbc 40032-762 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET SUBLINGUAL 20160322 ANDA ANDA204299 Novel Laboratories, Inc. ZOLPIDEM TARTRATE 1.75 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 40032-770_748f3208-fd88-419b-a561-393ecf260a3a 40032-770 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20170707 ANDA ANDA204652 Novel Laboratories, Inc. FLUCYTOSINE 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20181231 40032-771_748f3208-fd88-419b-a561-393ecf260a3a 40032-771 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20170707 ANDA ANDA204652 Novel Laboratories, Inc. FLUCYTOSINE 250 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20181231 40032-790_b42b64bd-caab-440c-9b72-5b80f84e5eb2 40032-790 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20150528 ANDA ANDA204446 Novel Laboratories, Inc. DOXYCYCLINE 50 mg/1 E 20171231 40032-791_b42b64bd-caab-440c-9b72-5b80f84e5eb2 40032-791 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20150528 ANDA ANDA204446 Novel Laboratories, Inc. DOXYCYCLINE 75 mg/1 E 20171231 40032-792_b42b64bd-caab-440c-9b72-5b80f84e5eb2 40032-792 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20150528 ANDA ANDA204446 Novel Laboratories, Inc. DOXYCYCLINE 100 mg/1 E 20171231 40032-794_1d517278-c0b0-4cc2-870a-7ece1cabcd51 40032-794 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20170906 ANDA ANDA207558 Novel Laboratories, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 40032-810_d5d8ebf0-7a3e-48d4-842b-a49aef28e2ac 40032-810 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP ORAL 20170213 ANDA ANDA203535 Novel Laboratories, Inc. HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 40032-870_522d3dbb-521e-4d0b-9d95-dee25e3bd83c 40032-870 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate dextroamphetamine sulfate TABLET ORAL 20160316 ANDA ANDA204330 Novel Laboratories, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 40032-871_522d3dbb-521e-4d0b-9d95-dee25e3bd83c 40032-871 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate dextroamphetamine sulfate TABLET ORAL 20160316 ANDA ANDA204330 Novel Laboratories, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 40032-910_7727e564-3680-4c51-897b-b35b74a33db2 40032-910 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20160815 ANDA ANDA204828 Novel Laboratories, Inc. POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 40032-911_7727e564-3680-4c51-897b-b35b74a33db2 40032-911 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20160815 ANDA ANDA204828 Novel Laboratories, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 40032-912_b216655b-e1f1-4df1-a94e-f1fa17502290 40032-912 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20160809 ANDA ANDA206759 Novel Laboratories, Inc. POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 40032-913_b216655b-e1f1-4df1-a94e-f1fa17502290 40032-913 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20160809 ANDA ANDA206759 Novel Laboratories, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 40032-915_f612de1e-c471-4b2b-abf7-195fc5169012 40032-915 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20160121 ANDA ANDA206347 Novel Laboratories, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 40032-917_f612de1e-c471-4b2b-abf7-195fc5169012 40032-917 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20160121 ANDA ANDA206347 Novel Laboratories, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 40032-920_f7978574-d8af-4b43-a12c-18e8045dccdf 40032-920 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20150429 ANDA ANDA204603 Novel Laboratories, Inc. OXYCODONE HYDROCHLORIDE 20 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 40032-930_819b1827-90f9-4378-9dfb-6fee92e90db9 40032-930 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20150814 ANDA ANDA204602 Novel laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 40032-931_819b1827-90f9-4378-9dfb-6fee92e90db9 40032-931 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20150814 ANDA ANDA204602 Novel laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 40032-950_9b75e3ea-57db-4c56-898f-79fddb21de9b 40032-950 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20150824 ANDA ANDA204752 Novel Laboratories, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 40032-980_79b1eb69-36b1-41ca-8ecd-a90bcc361ac7 40032-980 HUMAN PRESCRIPTION DRUG Carbidopa Carbidopa TABLET ORAL 20171020 ANDA ANDA204763 Novel Laboratories, Inc. CARBIDOPA 25 mg/1 N 20181231 40032-999_c42fae45-bbcf-40b6-911d-ebe3893f10ba 40032-999 HUMAN PRESCRIPTION DRUG cevimeline hydrochloride cevimeline hydrochloride CAPSULE ORAL 20161230 ANDA ANDA204746 Novel Laboratories, Inc. CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 40042-015_abeecced-ec75-467b-91bb-d8dc1d6de50b 40042-015 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC 20080116 ANDA ANDA078598 PharmaForce, Inc. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 40042-047_48a0e4e8-5520-4789-b508-deef6d0f3aa1 40042-047 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20091117 ANDA ANDA090534 PharmaForce, Inc. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 40042-048_f8cfe50b-e269-47f2-8ce6-0b40511945bc 40042-048 HUMAN PRESCRIPTION DRUG Betamethasone Sodium Phosphate and Betamethasone Acetate Betamethasone Sodium Phosphate and Betamethasone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR 20090731 ANDA ANDA090747 PharmaForce, Inc. BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 40042-049_243c0b7c-8011-4a94-8b25-0329de936439 40042-049 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20100121 ANDA ANDA090395 PharmaForce, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 40042-050_dc3647a7-842f-46ab-8b42-d19e66a251e9 40042-050 HUMAN PRESCRIPTION DRUG Progesterone Injection USP Progesterone Injection INJECTION, SOLUTION INTRAMUSCULAR 20090904 ANDA ANDA090845 PharmaForce, Inc. PROGESTERONE 50 mg/mL Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 40042-052_f89df25e-bb64-4351-b3b4-c3eb34843648 40042-052 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride INJECTION, SOLUTION EPIDURAL 20091016 ANDA ANDA091104 PharmaForce, Inc. CLONIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 40042-053_f89df25e-bb64-4351-b3b4-c3eb34843648 40042-053 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride INJECTION, SOLUTION EPIDURAL 20091016 ANDA ANDA091104 PharmaForce, Inc. CLONIDINE HYDROCHLORIDE 500 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 40046-0030_55e576e5-b615-429a-90f5-f741d3d48209 40046-0030 HUMAN OTC DRUG TENDERTONE LIP BALM SPF 12 OCTINOXATE, OCTISALATE, and AVOBENZONE LIPSTICK TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 2; 1.5 mL/100mL; mL/100mL; mL/100mL E 20171231 40046-0031_dd5fb00e-588e-4ebc-be2e-9a2444101961 40046-0031 HUMAN OTC DRUG MINERALIZE SPF 15 FOUNDATION LOOSE TITANIUM DIOXIDE POWDER TOPICAL 20070901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS TITANIUM DIOXIDE 7 g/100g N 20181231 40046-0032_5a09d299-9c80-4b6b-bdeb-4ffe9f290c77 40046-0032 HUMAN OTC DRUG STUDIO SCULPT SPF 15 FOUNDATION OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 MAKE UP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7; 2 mL/100mL; mL/100mL N 20181231 40046-0033_b1fa5950-814e-4a88-9c8d-501afad0426e 40046-0033 HUMAN OTC DRUG STUDIO MOISTURE TINT SPF 15 OCTINOXATE GEL TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 MAKE UP ART COSMETICS OCTINOXATE 3.5 mL/100mL E 20171231 40046-0034_1422a024-5cb7-4816-8c80-5981039d666d 40046-0034 HUMAN OTC DRUG SUNTINTS LIQUID LIP BALM SPF 20 OCTINOXATE, OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE LIPSTICK TOPICAL 20091201 OTC MONOGRAPH FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE 7.5; 5; 3; 2.9; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 40046-0036_e9ac9caf-34b9-4218-ae0a-fa2182c2898f 40046-0036 HUMAN OTC DRUG PREP (plus) PRIME BEAUTY BALM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 MAKE-UP ART COSMETICS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.4; 4; 2.5; 1.1; 3.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 40046-0037_db752197-9555-43ce-adc3-7fb0b7194f2c 40046-0037 HUMAN OTC DRUG MINERALIZE FOUNDATION SPF 15 OCTINOXATE CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 MAKE-UP ART COSMETICS OCTINOXATE 10 g/100g E 20171231 40046-0038_cd90398a-c66c-4466-999a-36aeaf8f659c 40046-0038 HUMAN OTC DRUG PRO-LONGWEAR SPF 10 FOUNDATION TITANIUM DIOXIDE LOTION TOPICAL 20100409 OTC MONOGRAPH NOT FINAL part352 MAKE UP ART COSMETICS TITANIUM DIOXIDE 4.7 mL/100mL E 20171231 40046-0039_8e82c4a4-fbc9-46bb-980e-31e302be7f7a 40046-0039 HUMAN OTC DRUG PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE CREAM TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE; TITANIUM DIOXIDE 7.4; 4; 3.5; 2.5; 1.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 40046-0040_03403b18-7531-4a12-861c-95e588209f38 40046-0040 HUMAN OTC DRUG LIP CONDITIONER SPF 15 PLUS LAVENDER OCTINOXATE, OCTISALATE GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE 7.5; 5 mL/100mL; mL/100mL E 20171231 40046-0041_35751f57-240d-4e3e-b319-367fa63d7b78 40046-0041 HUMAN OTC DRUG TINTED LIP CONDITIONER SPF 15 PLUS LAVENDER OCTINOXATE, OCTISALATE GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE 7.5; 5 mL/100mL; mL/100mL E 20171231 40046-0042_a1fab374-4119-4c1a-8072-28717a6719ff 40046-0042 HUMAN OTC DRUG MINERALIZE SATIN FOUNDATION SPF 15 FOUNDATION OCTINOXATE LIQUID TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE 7.5 mL/100mL N 20181231 40046-0043_91e3d67c-7165-4b28-9971-eea8e344c183 40046-0043 HUMAN OTC DRUG SMASHBOX CAMERA READY 5 IN 1 BEAUTY BALM SPF 35 OCTINOXlATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 4; 2.5; 1.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 40046-0044_a033dc14-b42a-4f9f-b9f9-e00c1d8cb49d 40046-0044 HUMAN OTC DRUG SMASH BOX STUDIO SKIN 15 HOUR WEAR HYDRATING FOUNDATION SPF10 TITANIUM DIOXIDE LIQUID TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS TITANIUM DIOXIDE 4.7 mL/100mL E 20171231 40046-0045_3382b9c9-82da-45fa-bffa-c2f2574bbf50 40046-0045 HUMAN OTC DRUG MATCHMASTER FOUNDATION SPF 15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 3.4; 1 mL/100mL; mL/100mL E 20171231 40046-0046_39b10a01-cdd9-4b41-857e-3f8ea313843a 40046-0046 HUMAN OTC DRUG STUDIO MOISTURE FIX SPF 15 ZINC OXIDE, OCTINOXATE LOTION TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part352 MAKE UP ART COSMETICS ZINC OXIDE; OCTINOXATE 6.7; 3.5 mL/100mL; mL/100mL E 20171231 40046-0047_6fbe638f-1a52-49ec-bede-ae636d329516 40046-0047 HUMAN OTC DRUG PREP and PRIME FACE PROTECTION SPF 50 ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20060201 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS ZINC OXIDE; OCTINOXATE 16.1; 7.5 mL/100mL; mL/100mL N 20181231 40046-0048_c0ed0ee1-0b8a-4e11-aec8-dfc9d6b56ab4 40046-0048 HUMAN OTC DRUG STUDIO FINISH CONCEALER SPF 35 OCTINOXATE, TITANIUM DIOXIDE PASTE TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 5; 2 g/100g; g/100g N 20181231 40046-0049_f0d2beaa-423a-4249-9e76-fc10fb872ccb 40046-0049 HUMAN OTC DRUG TINTED LIP CONDITIONER SPF 15 OCTINOXATE, OCTISALATE GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE 7.5; 5 mL/100mL; mL/100mL E 20171231 40046-0050_9c8e9fd8-4461-4da6-9b00-5090973c5df9 40046-0050 HUMAN OTC DRUG STUDIO FIX FLUID SPF 15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20051201 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 2.5; 1 mL/100mL; mL/100mL E 20171231 40046-0051_c259abd1-3cea-4574-bfb1-136b398f5fc1 40046-0051 HUMAN OTC DRUG TINTED LIP CONDITIONER SPF 15 OCTINOXATE, OCTISALATE GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE 7.5; 5 mL/100mL; mL/100mL E 20171231 40046-0052_abb755c2-8e3b-40d7-8e49-4d5061a09bc8 40046-0052 HUMAN OTC DRUG SELECT SPF 15 FOUNDATION OCTINOXATE CREAM TOPICAL 20011201 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE 7.5 mL/100mL E 20171231 40046-0053_6615a397-12dd-44e8-ac96-f91bdd8b7e0f 40046-0053 HUMAN OTC DRUG LIP CONDITIONER SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part352 MAKE UP ART COSMETICS OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 5; 1 g/100g; g/100g; g/100g N 20181231 40046-0055_dfe7bfbf-48b3-45c5-a9ab-ba24812df845 40046-0055 HUMAN OTC DRUG MAC SELECT TINT SPF 15 OCTINOXATE LIQUID TOPICAL 20020801 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE 7.5 mL/100mL E 20171231 40046-0056_c536f599-2180-45b3-a767-bf3923768d77 40046-0056 HUMAN OTC DRUG MAC HYPER REAL SPF 15 FOUNDATION OCTINOXATE LIQUID TOPICAL 20030601 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE 7 mL/100mL E 20171231 40046-0057_6ac61092-2d20-45fd-a03b-e3be163388b1 40046-0057 HUMAN OTC DRUG STUDIO FOUNDATION SPF 15 OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20030806 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 5; 2.9 g/100g; g/100g E 20171231 40046-0061_d5052f50-2eb8-4113-9295-08b753512025 40046-0061 HUMAN OTC DRUG MINERALIZE MOISTURE SPF 15 FOUNDATION OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.5; 2 mL/100mL; mL/100mL N 20181231 40046-0062_c3c7b78b-aaf3-428b-9797-0abc3aa3781c 40046-0062 HUMAN OTC DRUG PREP PLUS PRIME BB BEAUTY BALM COMPACT BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 9.8; 6.3 g/100g; g/100g; g/100g; g/100g N 20181231 40046-0064_3f1bc5ad-729f-4334-98b2-b44e160dfbe8 40046-0064 HUMAN OTC DRUG PREP (AND) PRIME BB BEAUTY BALM SPF 35 BROAD SPECTRUM SUNCREEN OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .08175; .0436; .02725; .01199 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 40046-0066_23e2d242-4e01-49d0-adca-6a1b2eb13e08 40046-0066 HUMAN OTC DRUG MATCHMASTER SPF 15 FOUNDATION BROAD SPECTRUM OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE .03723; .01095 g/100mL; g/100mL N 20181231 40046-0068_7a5a7396-f72d-4e75-b7bd-8ce9b4ac718d 40046-0068 HUMAN OTC DRUG PREP AND PRIME BLEMISH CONTROL ACNE TREATMENT SALICYLIC ACID GEL TOPICAL 20130101 OTC MONOGRAPH FINAL part333D MAKEUP ART COSMETICS SALICYLIC ACID .008776 g/mL N 20181231 40046-0069_4f2ff19c-83c0-4070-9897-248923241651 40046-0069 HUMAN OTC DRUG PREP (AND) PRIME CC COLOR CORRECT SPF30 BROAD SPECTRUM OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .08175; .0436; .02725; .01199; .03597 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 40046-0070_cbd9b6e3-522b-4262-bd4b-ce0dbef87574 40046-0070 HUMAN OTC DRUG LIGHTFUL C SPF 30 WITH RADIANCE BOOSTER BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .08175; .0436; .02725; .01199 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 40046-0071_c225b338-fc74-4541-bb6f-49b556a95680 40046-0071 HUMAN OTC DRUG MAC PRO LONGWEAR SPF 20 COMPACT FOUNDATION BROAD SPECTRUM SPF 20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE 2.4; 2.3 g/100g; g/100g N 20181231 40046-0072_924799ff-ae2c-4c52-bb90-d881104a60cb 40046-0072 HUMAN OTC DRUG STUDIO FIX FLUID SPF 15 BROAD SPECTRUM OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20051201 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE .027375; .01095 g/100mL; g/100mL N 20181231 40046-0073_1e27f8a9-48f8-4087-9022-f4dfbc09b3b3 40046-0073 HUMAN OTC DRUG STUDIO FIX FLUID BROAD SPECTRUM SPF 15 WITH ENRICHED ANTI-OXIDANT COMPLEX OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE .02775; .0111 g/100mL; g/100mL N 20181231 40046-0074_6e814b03-3209-4764-8bf9-a7fa14601627 40046-0074 HUMAN OTC DRUG MAC LIGHTFUL C MARINE BRIGHT FORMULA BS SPF 30 MOISTURIZER OCTINOXATE, OXYBENZONE, and ZINC OXIDE CREAM TOPICAL 20150216 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OXYBENZONE; ZINC OXIDE .08025; .02675; .0428 g/100mL; g/100mL; g/100mL N 20181231 40046-0075_ebc611a7-e3ec-4a02-8a6c-ed328cbe1dd2 40046-0075 HUMAN OTC DRUG MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREEN OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05425; .03364; .02279 g/100mL; g/100mL; g/100mL N 20181231 40046-0076_d745a236-3e4d-4c2d-a3f6-670518d1599a 40046-0076 HUMAN OTC DRUG STUDIO MOISTURE FIX BROAD SPECTRUM SPF 15 Avobenzone, Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .010105; .035545; .035545; .010105 g/mL; g/mL; g/mL; g/mL N 20181231 40046-0077_c118c247-7fe0-461c-a6be-004946b9c7d1 40046-0077 HUMAN OTC DRUG MAC LIGHTFUL Cplus CORAL GRASS TINTED WITH RADIANCE BOOSTER BROAD SPECTRUM SPF030 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 MAKEUP ART COSMETICS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 81.75; 43.6; 27.25; 11.99 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 40051-079_7c902b2c-edf6-4dd0-923f-c38f2c621733 40051-079 HUMAN PRESCRIPTION DRUG LEVETIRACETAM Extended-release levetiracetam TABLET ORAL 20161031 ANDA ANDA202095 Lotus Pharmaceutical Co., Ltd. Nantou Plant LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 40051-135_bfeea4b2-5d36-4ac4-9801-1b3edc9b9975 40051-135 HUMAN PRESCRIPTION DRUG LEVETIRACETAM levetiracetam TABLET, FILM COATED ORAL 20170330 ANDA ANDA090906 Lotus Pharmaceutical Co., Ltd. Nantou Plant LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 40051-136_bfeea4b2-5d36-4ac4-9801-1b3edc9b9975 40051-136 HUMAN PRESCRIPTION DRUG LEVETIRACETAM levetiracetam TABLET, FILM COATED ORAL 20170330 ANDA ANDA090906 Lotus Pharmaceutical Co., Ltd. Nantou Plant LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 40051-137_bfeea4b2-5d36-4ac4-9801-1b3edc9b9975 40051-137 HUMAN PRESCRIPTION DRUG LEVETIRACETAM levetiracetam TABLET, FILM COATED ORAL 20170330 ANDA ANDA090906 Lotus Pharmaceutical Co., Ltd. Nantou Plant LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 40051-138_bfeea4b2-5d36-4ac4-9801-1b3edc9b9975 40051-138 HUMAN PRESCRIPTION DRUG LEVETIRACETAM levetiracetam TABLET, FILM COATED ORAL 20170330 ANDA ANDA090906 Lotus Pharmaceutical Co., Ltd. Nantou Plant LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 40051-332_7c902b2c-edf6-4dd0-923f-c38f2c621733 40051-332 HUMAN PRESCRIPTION DRUG LEVETIRACETAM Extended-release levetiracetam TABLET ORAL 20161031 ANDA ANDA202095 Lotus Pharmaceutical Co., Ltd. Nantou Plant LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 40054-1003_a60618c6-2d05-41eb-b6fb-03fea49106ae 40054-1003 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20100101 UNAPPROVED MEDICAL GAS Northeast Home Medical Supplies Inc. OXYGEN 99 L/100L N 20181231 40055-0614_6cafe16c-0be5-4e83-bbc6-77ce3e87f6c3 40055-0614 HUMAN OTC DRUG ANTIBACTERIAL WET WIPES TRAVEL PACK BENZALKONIUM CHLORIDE SWAB TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part333E Global Marketing Resources, Inc. BENZALKONIUM CHLORIDE .115 mL/100mL E 20171231 40055-0938_0f72f474-e616-46e2-9d6d-a49bb9b8590f 40055-0938 HUMAN OTC DRUG ANTIBACTERIAL WET WIPES BENZALKONIUM CHLORIDE SWAB TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part333E Global Marketing Resources, Inc. BENZALKONIUM CHLORIDE .115 mL/100mL E 20171231 40057-0001_70d9777d-38cb-443c-ab34-77a5caaa8ad3 40057-0001 HUMAN OTC DRUG Charm-Tex Antiperspirant Roll On Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY SOLUTION TOPICAL 20160717 OTC MONOGRAPH FINAL part350 Charm-tex Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .3 g/100mL N 20181231 40057-0002_89fe4012-68c4-44ce-add2-bca67d007382 40057-0002 HUMAN OTC DRUG Charm-Tex Antiperspirant Stick Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY SOLUTION TOPICAL 20160717 OTC MONOGRAPH FINAL part350 Charm-tex Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .3 g/100g N 20181231 40057-1000_43c0b759-3885-4dcc-8c8c-0a2d9bbc0211 40057-1000 HUMAN OTC DRUG Charm Tex Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110601 OTC MONOGRAPH FINAL part355 Charm Tex, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 40057-1001_7375cd98-281b-4ece-bdc5-14ab02eaf788 40057-1001 HUMAN OTC DRUG Charm Tex Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110601 OTC MONOGRAPH FINAL part355 Charm Tex, Inc. SODIUM FLUORIDE .22 g/100g E 20171231 40057-2000_053f2545-8f65-4817-badf-6edb97a7fd0d 40057-2000 HUMAN OTC DRUG Charm-Tex Deodorant Aluminum chlorohydrate STICK TOPICAL 20120117 OTC MONOGRAPH FINAL part350 Charm-Tex, Inc. ALUMINUM CHLOROHYDRATE 7.8 g/100g E 20171231 40057-2001_7ded3795-c298-43ac-8f15-7c02e9c8a167 40057-2001 HUMAN OTC DRUG Charm-Tex ANTIPERSPIRANT ROLL-ON DEODORANT Aluminum chlorohydrate GEL TOPICAL 20120117 OTC MONOGRAPH FINAL part350 Charm-Tex, Inc ALUMINUM CHLOROHYDRATE 7.8 mL/100mL E 20171231 40057-3000_76233513-b690-44a9-89fc-7b2744bb6a18 40057-3000 HUMAN OTC DRUG Antibacterial Bar Triclosan SOAP TOPICAL 20120229 OTC MONOGRAPH NOT FINAL part333E Charm-Tex, Inc TRICLOSAN .3 g/100g E 20171231 40057-4000_6ff42ad7-e1b1-4d22-978b-ccc10d4431fa 40057-4000 HUMAN OTC DRUG Charm-Tex Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20120117 OTC MONOGRAPH FINAL part350 Charm-Tex, Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 7.8 g/100g E 20171231 40057-6001_c33f1c1c-c302-4576-a2ca-804d46afbe97 40057-6001 HUMAN OTC DRUG Charm-Tex ANTIPERSPIRANT ROLL-ON DEODORANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY GEL TOPICAL 20120117 OTC MONOGRAPH FINAL part350 Charm-Tex, Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .3 mL/100mL E 20171231 40061-990_3ab4001b-7023-42f0-bb32-f5d48a3603d9 40061-990 HUMAN OTC DRUG Patricks Sunscreen Avobenzone, Octinoxate, Octocrylene, Oxybenzone LOTION TOPICAL 20110428 OTC MONOGRAPH FINAL part352 O.P. Products, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 2; 7.25; 9.75; 3 g/100g; g/100g; g/100g; g/100g E 20171231 40076-002_f85fd6b6-3911-4450-9d2a-5c515e036614 40076-002 HUMAN PRESCRIPTION DRUG VUSION miconazole nitrate, zinc oxide, white petrolatum OINTMENT TOPICAL 20070514 NDA NDA021026 Prestium Pharma, Inc. MICONAZOLE NITRATE; ZINC OXIDE; PETROLATUM 2.5; 150; 813.5 mg/g; mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 40076-021_d1529ecd-dcb2-460b-9683-6013226a09e9 40076-021 HUMAN PRESCRIPTION DRUG Luxiq Betamethasone Valerate AEROSOL, FOAM TOPICAL 20091016 NDA NDA020934 Prestium Pharma, Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 40076-031_4270879b-60dd-486e-b1b7-ae35338772ee 40076-031 HUMAN PRESCRIPTION DRUG OLUX clobetasol propionate AEROSOL, FOAM TOPICAL 20140207 NDA NDA021142 Prestium Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 40076-051_5859d21a-3353-42d9-a68e-3a5c92ad053f 40076-051 HUMAN PRESCRIPTION DRUG EXTINA ketoconazole AEROSOL, FOAM TOPICAL 20140110 NDA NDA021738 Prestium Pharma, Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 40076-061_5bdefc76-3315-491a-8379-3c74df476e8e 40076-061 HUMAN PRESCRIPTION DRUG EVOCLIN clindamycin phosphate AEROSOL, FOAM TOPICAL 20140819 NDA NDA050801 Prestium Pharma, Inc. CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 40076-101_1b2616db-44bf-49b3-8e9e-af9e1df66137 40076-101 HUMAN PRESCRIPTION DRUG OLUX-E clobetasol propionate AEROSOL, FOAM TOPICAL 20070212 NDA NDA022013 Prestium Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 40076-230_5f66943b-b19d-4101-8f27-f011c92c3ae3 40076-230 HUMAN PRESCRIPTION DRUG elimite permethrin CREAM TOPICAL 20160127 NDA NDA019855 Prestium Pharma, Inc. PERMETHRIN 50 mg/100g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] N 20181231 40076-318_fcd12354-0dbb-5992-bb42-b1f2416e6541 40076-318 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride SUPPOSITORY RECTAL 20140801 ANDA ANDA040428 Prestium Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 40076-319_fcd12354-0dbb-5992-bb42-b1f2416e6541 40076-319 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride SUPPOSITORY RECTAL 20140801 ANDA ANDA040428 Prestium Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 40076-320_d92c1bdc-592d-9025-ae72-cd0176606286 40076-320 HUMAN PRESCRIPTION DRUG PHENERGAN Promethazine Hydrochloride SUPPOSITORY RECTAL 20140801 ANDA ANDA087165 Prestium Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 40076-415_ad92a507-602f-4758-9217-d1ad79c4fcb9 40076-415 HUMAN PRESCRIPTION DRUG ERYGEL erythromycin GEL TOPICAL 20160127 NDA NDA050617 Prestium Pharma, Inc. ERYTHROMYCIN 20 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 40076-511_d9fd0f4f-f51d-453d-805c-dfefec679452 40076-511 HUMAN PRESCRIPTION DRUG PRUDOXIN doxepin hydrochloride CREAM TOPICAL 20150601 NDA NDA020126 Prestium Pharma, Inc. DOXEPIN HYDROCHLORIDE 50 mg/g Tricyclic Antidepressant [EPC] N 20181231 40076-624_6b634e97-a6f8-4e46-9e73-88234d7fcc9f 40076-624 HUMAN PRESCRIPTION DRUG Denavir penciclovir CREAM TOPICAL 20121023 NDA NDA020629 Prestium Pharma, Inc. PENCICLOVIR 10 mg/g DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 40076-715_087ee995-7bdd-4710-b594-f85efc1e464e 40076-715 HUMAN PRESCRIPTION DRUG Zonalon doxepin hydrochloride CREAM TOPICAL 20150312 NDA NDA020126 Prestium Pharma, Inc. DOXEPIN HYDROCHLORIDE 50 mg/g Tricyclic Antidepressant [EPC] N 20181231 40076-945_cd7fb36b-986c-4360-8317-932904d90e03 40076-945 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir TABLET ORAL 20140207 NDA NDA020089 Prestium Pharma, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 40076-949_cd7fb36b-986c-4360-8317-932904d90e03 40076-949 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir TABLET ORAL 20140207 NDA NDA020089 Prestium Pharma, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 40076-953_cd7fb36b-986c-4360-8317-932904d90e03 40076-953 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir SUSPENSION ORAL 20140207 NDA NDA019909 Prestium Pharma, Inc. ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 40076-991_cd7fb36b-986c-4360-8317-932904d90e03 40076-991 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir CAPSULE ORAL 20140207 NDA NDA018828 Prestium Pharma, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 40085-028_c679d061-9577-4793-bf2a-4cba0b7029e2 40085-028 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20161001 NDA NDA011601 Renaissance Pharma, Inc. TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 40085-029_c679d061-9577-4793-bf2a-4cba0b7029e2 40085-029 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20161001 NDA NDA011601 Renaissance Pharma, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 40085-201_dc710113-e389-4915-a649-9512113e9b8e 40085-201 HUMAN PRESCRIPTION DRUG Naftifine Hydrochloride NAFTIFINE HYDROCHLORIDE CREAM TOPICAL 20150601 NDA NDA019599 Renaissance Pharma, Inc NAFTIFINE HYDROCHLORIDE 1 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 40085-203_de8dc243-5010-41e0-84cb-a3ae06d1d64d 40085-203 HUMAN PRESCRIPTION DRUG Naftifine Hydrochloride NAFTIFINE HYDROCHLORIDE CREAM TOPICAL 20160201 NDA NDA019599 Renaissance Pharma, Inc NAFTIFINE HYDROCHLORIDE 20 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 40085-215_f12ab183-1ee3-4435-9766-2eef67064077 40085-215 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20130627 ANDA ANDA076369 Renaissance Pharma, Inc. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] N 20181231 40085-218_5a8177c3-12e2-9e7b-dfe6-3b2a88d530dc 40085-218 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20140801 ANDA ANDA040428 Renaissance Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 40085-219_5a8177c3-12e2-9e7b-dfe6-3b2a88d530dc 40085-219 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20140801 ANDA ANDA040428 Renaissance Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 40085-220_9ad276ca-44ae-acfc-1046-3a501fd24d7d 40085-220 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20140801 ANDA ANDA087165 Renaissance Pharma, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 40085-315_c71c8fed-6106-40d0-ac0d-f397b1234104 40085-315 HUMAN PRESCRIPTION DRUG Erythromycin erythromycin GEL TOPICAL 20150701 NDA AUTHORIZED GENERIC NDA050617 Renaissance Pharma, Inc. ERYTHROMYCIN 20 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 40085-415_f56d602a-8050-46db-ad36-6f1584f314d1 40085-415 HUMAN PRESCRIPTION DRUG Penciclovir penciclovir CREAM TOPICAL 20161001 NDA AUTHORIZED GENERIC NDA020629 Renaissance Pharma, Inc. PENCICLOVIR 10 mg/g DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 40085-615_2f304332-220e-4992-9f65-13e511d9215f 40085-615 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20170629 NDA AUTHORIZED GENERIC NDA019855 Renaissance Pharma, Inc. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] N 20181231 40085-716_b66896d7-dd32-4252-bd30-51de93f9b6fd 40085-716 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CREAM TOPICAL 20160307 NDA AUTHORIZED GENERIC NDA020126 Renaissance Pharma, Inc. DOXEPIN HYDROCHLORIDE 50 mg/g Tricyclic Antidepressant [EPC] N 20181231 40085-842_e790678e-95dc-4de0-88e9-1ce6f3151eef 40085-842 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir SUSPENSION ORAL 20140903 NDA AUTHORIZED GENERIC NDA019909 Renaissance Pharma, Inc. ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 40085-888_4ba92556-59eb-49d8-9bc0-763102a15318 40085-888 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate AEROSOL, FOAM TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA021142 Renaissance Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 40085-893_70d14e78-f1ef-4485-9678-112ff9de02f0 40085-893 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Emulsion clobetasol propionate AEROSOL, FOAM TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA022013 Renaissance Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 40089-113_35cc3f2c-796a-4b38-8c25-7f1b802ddddc 40089-113 HUMAN PRESCRIPTION DRUG Ammonia N 13 NH3N13 INJECTION INTRAVENOUS 20120321 ANDA ANDA204514 The Johns Hopkins University AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 40092-500_858180c1-595c-4e25-99e8-ad5a97b0523c 40092-500 HUMAN OTC DRUG GOLDSHIELD 24 GS 24 BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20141121 OTC MONOGRAPH NOT FINAL part333A AP GOLDSHIELD LLC BENZALKONIUM CHLORIDE .001 g/g N 20181231 40092-500_913a01ff-4c4a-43c0-a75b-671ad6186d2c 40092-500 HUMAN OTC DRUG GOLDSHIELD 24 GS 24 BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20141121 OTC MONOGRAPH NOT FINAL part333A AP GOLDSHIELD LLC BENZALKONIUM CHLORIDE .001 g/g N 20181231 40092-600_57463cf7-60a1-487e-94b7-6ad473c349e4 40092-600 HUMAN OTC DRUG VETERAN SHIELD 24 VSH BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20120615 OTC MONOGRAPH NOT FINAL part333A AP GOLDSHIELD LLC BENZALKONIUM CHLORIDE .001 g/g N 20181231 40096-0050_40ca980f-2f6d-49cf-9184-f3c0afb7195e 40096-0050 HUMAN OTC DRUG TOUGH GUY Antimicrobial Ltion So ap Chloroxylenol LIQUID TOPICAL 20070915 OTC MONOGRAPH NOT FINAL part333E W.W. GRAINGER, INC. CHLOROXYLENOL .003 mg/mL N 20181231 40096-0051_db7fdd7f-84e1-4534-8336-ed5deb4dce88 40096-0051 HUMAN OTC DRUG TOUGH GUY 821 Antimicrobial Liquid Ltion So ap Chloroxylenol LIQUID TOPICAL 20081030 OTC MONOGRAPH NOT FINAL part333E W.W. GRAINGER, INC. CHLOROXYLENOL .003 mg/mL N 20181231 40096-0076_0f83381f-d53c-46a8-a106-174de48aaa0f 40096-0076 HUMAN OTC DRUG TOUGH GUY INSTANT HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333E W.W. Grainger, Inc. ALCOHOL 62 mL/100mL E 20171231 40096-0080_4b091feb-ccd3-47bb-87ce-6b8cde820c8f 40096-0080 HUMAN OTC DRUG TOUGH GUY Antimicrobial Foam So ap Chloroxylenol LIQUID TOPICAL 20070915 OTC MONOGRAPH NOT FINAL part333E W.W. GRAINGER, INC. CHLOROXYLENOL .003 mg/mL N 20181231 40096-0081_fbe44ecc-c7c7-4197-a786-3b771f9b943a 40096-0081 HUMAN OTC DRUG TOUGH GUY Antibacterial Foam Hand So ap Chloroxylenol LIQUID TOPICAL 20090415 OTC MONOGRAPH NOT FINAL part333E W.W. GRAINGER, INC. CHLOROXYLENOL .003 mg/mL N 20181231 40096-0700_8999680f-69f4-4e06-85df-0ac32b7e50f6 40096-0700 HUMAN OTC DRUG TOUGH GUY Instant Hand Sanitizer with Moisturizers and Vitamin E alcohol GEL TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part333E W.W. GRAINGER, INC. ALCOHOL .7 mL/mL N 20181231 40096-0800_53d7af8f-7a96-4c3a-b38b-dfc74ee4a173 40096-0800 HUMAN OTC DRUG TOUGH GUY Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20140815 OTC MONOGRAPH NOT FINAL part333E W.W. GRAINGER, INC. ALCOHOL .7 mL/mL N 20181231 40096-0802_0cf2ec12-156b-4a45-842d-85f0d44ed434 40096-0802 HUMAN OTC DRUG Tough Guy Hand Sanitizer Wipes Tough Guy Hand Sanitizer Wipes CLOTH TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 W.W. Grainger, Inc. BENZALKONIUM CHLORIDE; BENZETHONIUM CHLORIDE .1; .1 g/970mL; g/970mL E 20171231 40096-0965_50ad3476-3e60-4965-bffe-9b48580517ec 40096-0965 HUMAN OTC DRUG TOUGH GUY Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part333E W.W. GRAINGER, INC. ALCOHOL .62 mL/mL N 20181231 40098-101_416da85f-4cb1-409b-e054-00144ff88e88 40098-101 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F-18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20141030 ANDA ANDA203801 Trustees of the University of Pennsylvania FLUDEOXYGLUCOSE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 40104-001_4c45fa9f-5501-4ebf-aa2e-b8ea3dcafd13 40104-001 HUMAN OTC DRUG meijer kids BENZALKONIUM CHLORIDE LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co.,Ltd. BENZALKONIUM CHLORIDE .596 g/298g N 20181231 40104-002_8088ac42-2f8e-4457-ab24-433e3ef3c980 40104-002 HUMAN OTC DRUG meijer kids BENZALKONIUM CHLORIDE LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co.,Ltd. BENZALKONIUM CHLORIDE .596 g/298g N 20181231 40104-003_2834a2c2-43af-4261-af1d-ffe0b1de949a 40104-003 HUMAN OTC DRUG meijer kids BENZALKONIUM CHLORIDE LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co.,Ltd. BENZALKONIUM CHLORIDE .596 g/298g N 20181231 40104-139_d7453c11-5fa1-4037-90f3-5072378b24bf 40104-139 HUMAN OTC DRUG modesa antibacterial hand sanitizer lemon ALCOHOL GEL TOPICAL 20141216 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-180_950812ea-7597-400f-b3dd-172109cedb9d 40104-180 HUMAN OTC DRUG sedanos instant hand sanitizer with moistruizing formula ALCOHOL GEL TOPICAL 20160611 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-181_3c3b1e95-553f-4b41-9ba6-e052c52128cc 40104-181 HUMAN OTC DRUG rocksauce ice Methyl Salicylate, Menthol and Capsaicin CREAM TOPICAL 20170927 OTC MONOGRAPH NOT FINAL part348 Ningbo Pulisi Daily Chemical Products Co.,Ltd. METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 10; .2 mg/100mL; mg/100mL; mg/100mL N 20181231 40104-182_4cec2d52-1568-4966-9d03-d21c8c119602 40104-182 HUMAN OTC DRUG rocksauce fire Methyl Salicylate, Menthol and Capsaicin CREAM TOPICAL 20170927 OTC MONOGRAPH NOT FINAL part348 Ningbo Pulisi Daily Chemical Products Co.,Ltd. METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 10; .2 mg/100mL; mg/100mL; mg/100mL N 20191231 40104-191_e88342a7-409a-40d2-8e78-80cf76fce085 40104-191 HUMAN OTC DRUG Rock Sauce Chill (no color) MENTHOL GEL TOPICAL 20150509 OTC MONOGRAPH NOT FINAL part348 Ningbo Pulisi Daily Chemical Products Co., Ltd. MENTHOL 6 g/100g N 20181231 40104-192_7ed6fd51-c04a-4649-972c-626098df51c1 40104-192 HUMAN OTC DRUG Rock Sauce Chill (no color) MENTHOL GEL TOPICAL 20150509 OTC MONOGRAPH NOT FINAL part348 Ningbo Pulisi Daily Chemical Products Co., Ltd. MENTHOL 6 g/100g N 20181231 40104-193_36dff858-9be7-4141-8096-627742bbbf56 40104-193 HUMAN OTC DRUG rocksauce fire Methyl Salicylate, Menthol and Capsaicin CREAM TOPICAL 20170927 OTC MONOGRAPH NOT FINAL part348 Ningbo Pulisi Daily Chemical Products Co.,Ltd. METHYL SALICYLATE; MENTHOL; CAPSAICIN .02; .01; .000002 g/.1g; g/.1g; g/.1g N 20181231 40104-194_98d0329d-9663-4b23-adcd-33c022cd0121 40104-194 HUMAN OTC DRUG rock sauce Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20160811 OTC MONOGRAPH NOT FINAL part348 Ningbo Pulisi Daily Chemical Products Co.,Ltd. METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 10; .2 mg/100mL; mg/100mL; mg/100mL N 20181231 40104-196_5e0bbe96-e1b1-4089-b7e0-3762044cdf50 40104-196 HUMAN OTC DRUG rock sauce Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20161229 OTC MONOGRAPH NOT FINAL part348 Ningbo Pulisi Daily Chemical Products Co.,Ltd. METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 10; .2 mg/100mL; mg/100mL; mg/100mL N 20181231 40104-198_72352616-ea0f-4b56-bfdd-939368f54538 40104-198 HUMAN OTC DRUG rock sauce Methyl Salicylate, Menthol and Capsaicin CREAM TOPICAL 20170504 OTC MONOGRAPH NOT FINAL part348 Ningbo Pulisi Daily Chemical Products Co.,Ltd. METHYL SALICYLATE; MENTHOL; CAPSAICIN .02; .01; .000002 g/.1g; g/.1g; g/.1g N 20181231 40104-201_647e7ba5-7348-480a-8ecf-bce8d67e3e96 40104-201 HUMAN OTC DRUG 2 Pack Assured Instant Hand Sanitizer with moisturizers (Vitamin E and aloe) lemon scented ALCOHOL GEL TOPICAL 20140510 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-204_d123c180-f295-4d6c-bbbc-f83eb90c4a62 40104-204 HUMAN OTC DRUG My Little Pony Antibacterial Hand Sanitizer with Moisturizers Alcohol GEL TOPICAL 20150205 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-261_2b7387cb-b004-4254-a00b-ee577a5078a6 40104-261 HUMAN OTC DRUG Faith Family Ducks Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-262_7b2425b4-fb13-4b3c-9eef-8011aba3719c 40104-262 HUMAN OTC DRUG Superman Berry Scented Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-263_08398e23-6e5b-4f0b-a8df-623f3c55fb42 40104-263 HUMAN OTC DRUG Batman Berry Scented Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-281_5bb95936-f42b-4458-8e67-91dac5906bb7 40104-281 HUMAN OTC DRUG aurafresh instant hand sanitizer with moisturizeers vitamin E and aloe ALCOHOL GEL TOPICAL 20170810 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-282_e235270a-d4c9-4a90-8262-81088cee917f 40104-282 HUMAN OTC DRUG aurafresh instant hand sanitizer with moisturizers aloe vera and moisturizers ALCOHOL GEL TOPICAL 20170810 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-283_805919bf-734b-476c-af2c-546ceee69fdb 40104-283 HUMAN OTC DRUG aurafresh instant hand sanitizer aloe vera ALCOHOL GEL TOPICAL 20170811 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 70 mL/100mL N 20181231 40104-284_3c4c7f0e-f610-4fdd-905a-9e5f464b2bb5 40104-284 HUMAN OTC DRUG aurafresh instant hand sanitizer vitamin e ALCOHOL GEL TOPICAL 20170810 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 70 mL/100mL N 20181231 40104-285_c9d9578a-9da9-42bd-ab8f-e5875c0ae258 40104-285 HUMAN OTC DRUG aurafresh instant hand sanitizer with aloe and vitamin e fresh citrus ALCOHOL GEL TOPICAL 20170810 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-286_dc9e3a9d-03a6-4d49-ad4f-c8389b2575a8 40104-286 HUMAN OTC DRUG aurafresh instant hand sanitizer with aloe and vitamin e lavender ALCOHOL GEL TOPICAL 20170810 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-287_a4022029-b047-4bb2-9c3c-140ec15e606a 40104-287 HUMAN OTC DRUG aurafresh instant hand sanitizer with aloe and vitamin e berries ALCOHOL GEL TOPICAL 20170810 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-288_3a16a4fb-d106-4603-974c-0fcb9f1fa3ab 40104-288 HUMAN OTC DRUG aurafresh instant hand sanitizer with aloe and vitamin e original ALCOHOL GEL TOPICAL 20170810 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-289_455837d1-3ae5-4ae0-bdaa-3f6be93d369e 40104-289 HUMAN OTC DRUG nickelodeon jojo siwa hand sanitizer berry sweet scent ALCOHOL GEL TOPICAL 20170929 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 70 mL/100mL N 20181231 40104-291_94e60c16-f6f3-4777-ad36-e438afb40550 40104-291 HUMAN OTC DRUG Oil-Free Acne Wash Salicylic Acid LOTION TOPICAL 20170817 OTC MONOGRAPH FINAL part333D Ningbo Pulisi Daily Chemical Products Co.,Ltd. SALICYLIC ACID 20 mg/mL N 20181231 40104-299_d8eaf690-7aef-43fb-8e87-c6b9d31c3a84 40104-299 HUMAN OTC DRUG rocksauce ice Menthol CREAM TOPICAL 20171205 OTC MONOGRAPH NOT FINAL part348 Ningbo Pulisi Daily Chemical Products Co.,Ltd. MENTHOL .006 g/.1g N 20181231 40104-323_41a2f7ee-963b-4a84-b65f-8795140f3bd7 40104-323 HUMAN OTC DRUG 3 Pack Assured Instant Hand Sanitizer with moisturizers (Vitamin E and aloe) lemon scented ALCOHOL GEL TOPICAL 20141102 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-324_641a5b8b-b746-49d1-8912-bdb084f0ccfe 40104-324 HUMAN OTC DRUG 3 Pack Assured Instant Hand Sanitizer with moisturizers (Vitamin E and moisturizers) lavender scented ALCOHOL GEL TOPICAL 20141102 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-325_16554444-a342-48d0-8a2d-5f0abd5b9bd1 40104-325 HUMAN OTC DRUG 3 Pack Assured Instant Hand Sanitizer with moisturizers (aloe vera and moisturizers) ALCOHOL GEL TOPICAL 20141102 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-330_eaf38fde-3f4d-4c41-a15a-72ae697577ca 40104-330 HUMAN OTC DRUG 3 Hand Sanitizers ALCOHOL KIT TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co.,Ltd. N 20181231 40104-351_df5afbde-2045-40fc-a964-a9243fe13dc3 40104-351 HUMAN OTC DRUG Lalaloopsy Watermelon Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140902 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-352_67528bf0-33de-4ecf-bb76-bbe892d791b9 40104-352 HUMAN OTC DRUG Lisa Frank Bubblegum Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140902 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-353_0c6aa7fd-95d1-418f-8786-623bdcd96b93 40104-353 HUMAN OTC DRUG My Little Pony Grape Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140902 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-354_3fd43e84-9c84-49f1-9b78-4f0d8e90c283 40104-354 HUMAN OTC DRUG Care Bears Cotton Candy Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140902 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-355_2189112e-ecbf-40c3-a36c-b6a121979a7c 40104-355 HUMAN OTC DRUG Strawberry Shortcake Berry Best Friends Mixed Berry Antiseptic Hand Cleansing ALCOHOL GEL TOPICAL 20140902 OTC MONOGRAPH NOT FINAL part333E Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-360_be970ecb-b337-4da7-aff9-9b87483321c5 40104-360 HUMAN OTC DRUG 3 Pack Family Dollar instant Hand Sanitizers Alcohol KIT 20141128 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. N 20181231 40104-371_97bb8e41-116c-487b-bed3-56b6c3df29fe 40104-371 HUMAN OTC DRUG paw patrol mashall hand sanitizer (berry scent) ALCOHOL GEL TOPICAL 20170818 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 70 mL/100mL N 20181231 40104-372_90feb52a-9978-4985-9078-d6189a52893f 40104-372 HUMAN OTC DRUG paw patrol chase hand sanitizer (berry scent) ALCOHOL GEL TOPICAL 20170818 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 70 mL/100mL N 20181231 40104-373_e7eff467-4459-4c76-96ef-4b99873a47e5 40104-373 HUMAN OTC DRUG paw patrol jkye hand sanitizer (berry scent) ALCOHOL GEL TOPICAL 20170818 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 70 mL/100mL N 20181231 40104-380_9a67b48b-8ba3-4f86-82d0-7b50e07d8b80 40104-380 HUMAN OTC DRUG Halsa anti Dandruff moisturizes and restores PYRITHIONE ZINC SHAMPOO TOPICAL 20170923 OTC MONOGRAPH FINAL part358H NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. PYRITHIONE ZINC 1 g/100mL N 20181231 40104-381_0de8ccd1-365f-49dd-86c5-26b27be18ee3 40104-381 HUMAN OTC DRUG rocksauce ice Menthol CREAM TOPICAL 20171205 OTC MONOGRAPH NOT FINAL part348 Ningbo Pulisi Daily Chemical Products Co.,Ltd. MENTHOL 6 mg/100mL N 20181231 40104-421_eb8d696b-1b82-48ac-aa67-094ba5d82db5 40104-421 HUMAN OTC DRUG amoray premium instant hand sanitizer with aloe and vitamin e lavender ALCOHOL GEL TOPICAL 20151216 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-422_2cb5bdda-3e2c-4e77-8a76-f2fa4bb5e4a6 40104-422 HUMAN OTC DRUG amoray premium instant hand sanitizer with aloe and vitamin e strawberry ALCOHOL GEL TOPICAL 20151216 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-423_52a1b483-8a5a-4d28-8950-51c8ac89c363 40104-423 HUMAN OTC DRUG amoray premium instant hand sanitizer with aloe and vitamin e fresh citrus ALCOHOL GEL TOPICAL 20151216 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-424_daefdf3e-07cb-4286-a239-8d667f592b3b 40104-424 HUMAN OTC DRUG amoray premium instant hand sanitizer with aloe and vitamin e original ALCOHOL GEL TOPICAL 20151216 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 40104-520_7bc30483-f769-4cc9-83cf-f30a3c8ab0c3 40104-520 HUMAN OTC DRUG Family Dollar Instant Hand Sanitizer with Moisturizers and Vitamin E Alcohol GEL TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part333A Ningbo Pulisi Daily Chemical Products Co., Ltd. ALCOHOL 65 mL/100mL N 20181231 40104-556_9f62a572-23d1-409d-859e-711ee23e7aef 40104-556 HUMAN OTC DRUG Virx Instant Hand Sanitizing Spray with Aloe Vera SPRAY TOPICAL 20090930 OTC MONOGRAPH FINAL part333 Ningbo Pulisi Daily Chemical Products Co., Ltd TRICLOSAN 1.2 mL/10mL E 20171231 40104-703_50116fe2-1df8-4744-a712-188025007da1 40104-703 HUMAN OTC DRUG Virx Instant Hand Sanitizer GEL TOPICAL 20100201 OTC MONOGRAPH FINAL part333 Ningbo Pulisi Daily Chemical Products Co., Ltd ALCOHOL 618.1 mL/947mL E 20171231 40104-800_71607b3f-aac5-4d9f-bc7b-b968f7b1baff 40104-800 HUMAN OTC DRUG amoray premium Vaporizing Inhaler menthol LIQUID NASAL 20160331 OTC MONOGRAPH FINAL part341 Ningbo Pulisi Daily Chemical Products Co.,Ltd. CAMPHOR (NATURAL) 13 mg/1 N 20181231 40104-811_96fb17ee-eb73-4082-b423-7736820e1906 40104-811 HUMAN OTC DRUG Virx Hand Sanitizer and Moisturizer with Shea Butter LOTION TOPICAL 20090930 OTC MONOGRAPH FINAL part333 Ningbo Pulisi Daily Chemical Products ALCOHOL 154 mL/236mL E 20171231 40171-005_27fb8d97-2678-4ecf-9f81-afb0d29588cc 40171-005 HUMAN OTC DRUG blink tears polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20160315 OTC MONOGRAPH FINAL part349 Abbott Medical Optics Inc. POLYETHYLENE GLYCOL 400 2.5 mg/mL N 20181231 41163-001_1c69e48d-13c5-4469-876c-62b7f750e68c 41163-001 HUMAN OTC DRUG equaline heartburn prevention Famotidine TABLET ORAL 20141205 ANDA ANDA077351 Supervalu Inc FAMOTIDINE 20 mg/1 N 20181231 41163-003_28fbf855-39a3-4259-aa81-5ce008e009c9 41163-003 HUMAN OTC DRUG Body Menthol POWDER TOPICAL 20130927 OTC MONOGRAPH NOT FINAL part348 Supervalu MENTHOL 1.5 mg/g N 20181231 41163-004_2909ace0-2750-4aec-b638-7a0d8d040d92 41163-004 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20110817 OTC MONOGRAPH FINAL part355 Supervalu, Inc SODIUM FLUORIDE 10.4 mg/mL N 20181231 41163-005_fa221e9e-1f23-4cad-88d6-6a32833fa81f 41163-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Supervalu Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL N 20181231 41163-006_ffae856e-3ac5-4dc5-802c-7a86c9baa6a8 41163-006 HUMAN OTC DRUG Stool Softener easy and gentle DOCUSATE SODIUM CAPSULE ORAL 20130404 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM 100 mg/1 N 20181231 41163-007_8c69248d-bcdd-4b0c-a6eb-4bfbcf83e6d5 41163-007 HUMAN OTC DRUG equaline first aid antibiotic Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20150331 OTC MONOGRAPH FINAL part333B Supervalu Inc NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g N 20181231 41163-009_3c0a416c-35f6-4976-bbb0-d5b6145379e0 41163-009 HUMAN OTC DRUG Calamine Calamine, Pramoxind HCl LOTION TOPICAL 20090521 OTC MONOGRAPH FINAL part347 Super valu, Inc FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 8.6; 20; 10 mg/mL; mg/mL; mg/mL N 20181231 41163-010_a83613f5-dad2-4a19-9597-601b930b0ada 41163-010 HUMAN OTC DRUG Non Drowsy Cold and Cough PE Acetaminophen, Dextromathorphan HBr, Gauifenesin, Phenylephrine HCl CAPSULE, COATED ORAL 20070222 20181105 OTC MONOGRAPH FINAL part341 SUPERVALU INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 41163-011_702bbb32-20d3-4e25-adb2-c957f42002c2 41163-011 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20151218 OTC MONOGRAPH FINAL part355 Supervalu Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 41163-012_ce9f9d3d-996c-4bec-b988-fffdef163f76 41163-012 HUMAN OTC DRUG equaline nicotine Nicotine polacrilex GUM, CHEWING ORAL 20170606 ANDA ANDA206394 Supervalu Inc NICOTINE 2 mg/1 N 20181231 41163-013_39df50ec-b7d3-4f07-9675-52ad19ccef8c 41163-013 HUMAN OTC DRUG equaline allergy and congestion relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20130213 ANDA ANDA076050 Supervalu Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 41163-015_4ae48b67-19dd-48e1-9dca-b4fea47c7b4a 41163-015 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130826 OTC MONOGRAPH NOT FINAL part356 Supervalu, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41163-016_f8f88d9d-723a-4c5f-8000-b81745e994f5 41163-016 HUMAN OTC DRUG equaline triple antibiotic bacitracin zinc, neomycin sulfate, and polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Supervalu Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 41163-017_22345f2a-8718-41ce-a7c3-40d47790c652 41163-017 HUMAN OTC DRUG First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20120308 OTC MONOGRAPH NOT FINAL part333E Supervalu Inc POVIDONE-IODINE 10 mg/mL N 20181231 41163-019_fab1df24-368a-4e4e-bedf-2461286e3b16 41163-019 HUMAN OTC DRUG allergy relief diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 SUPERVALU INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41163-021_44aaccba-036f-63dc-e054-00144ff8d46c 41163-021 HUMAN OTC DRUG mixed berry sore throat and cough lozenge benzocaine LOZENGE ORAL 20151016 OTC MONOGRAPH NOT FINAL part356 Super Valu DEXTROMETHORPHAN HYDROBROMIDE; BENZOCAINE 5; 7.5 mg/1; mg/1 N 20181231 41163-023_ca3d6846-be01-44c0-8990-e060894eafab 41163-023 HUMAN OTC DRUG Equaline Fluticasone Propionate Fluticasone propionate SPRAY, METERED NASAL 20160531 ANDA ANDA207957 Supervalu Inc FLUTICASONE PROPIONATE 50 ug/1 N 20191231 41163-024_ac4ed238-f482-4416-95d9-4e7fe9c94df8 41163-024 HUMAN OTC DRUG Dandruff PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20061026 OTC MONOGRAPH FINAL part358H SUPERVALUE INC. PYRITHIONE ZINC 10 mg/mL N 20181231 41163-025_46794453-abbb-1625-e054-00144ff8d46c 41163-025 HUMAN OTC DRUG menthol cough drop cherry LOZENGE ORAL 20140618 OTC MONOGRAPH FINAL part341 Equaline MENTHOL 5.8 mg/1 N 20181231 41163-026_468ca758-4c6e-5a67-e054-00144ff88e88 41163-026 HUMAN OTC DRUG menthol cough drop Honey Lemon LOZENGE ORAL 20140618 OTC MONOGRAPH FINAL part341 Equaline MENTHOL 7.5 mg/1 N 20181231 41163-027_46c466d7-26cb-5179-e054-00144ff88e88 41163-027 HUMAN OTC DRUG SF menthol cough drop menthol LOZENGE ORAL 20140618 OTC MONOGRAPH FINAL part341 Equaline MENTHOL 5.8 mg/1 N 20181231 41163-028_46de05ae-e0f9-6788-e054-00144ff88e88 41163-028 HUMAN OTC DRUG SF menthol cough drop SF Honey lemon LOZENGE ORAL 20140618 OTC MONOGRAPH FINAL part341 Equaline MENTHOL 7.6 mg/1 N 20181231 41163-029_6dcdd947-b78f-4638-abfb-2a3a0773426b 41163-029 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080917 ANDA ANDA076775 Supervalu Inc NICOTINE 2 mg/1 N 20181231 41163-032_e99c3066-a16d-4940-9001-2d83b77f7176 41163-032 HUMAN OTC DRUG Equaline Tioconazole 1 Tioconazole OINTMENT VAGINAL 20160308 ANDA ANDA075915 Supervalu Inc TIOCONAZOLE 6.5 g/100g N 20181231 41163-033_50c1ba77-9dd2-5292-e054-00144ff8d46c 41163-033 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20170523 OTC MONOGRAPH FINAL part341 SUPERVALU INC. MENTHOL 7.5 mg/1 N 20181231 41163-034_50c07119-4034-3e85-e054-00144ff88e88 41163-034 HUMAN OTC DRUG Sugar Free Menthol Cough Drop Menthol LOZENGE ORAL 20170523 OTC MONOGRAPH FINAL part341 Supervalu Inc. MENTHOL 5.8 mg/1 N 20181231 41163-035_90f2c045-5daf-4a4a-91fe-7ce770782085 41163-035 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 650; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 41163-036_b0cf4c2e-b603-4e2b-ad8d-7b534b49f6dc 41163-036 HUMAN OTC DRUG Mucus Relief Cold Flu Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140530 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 41163-037_57757d22-1a10-4f15-8cc2-9d92649986d0 41163-037 HUMAN OTC DRUG Mucus Relief Severe Congestion Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140530 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 41163-040_ccfdb873-0496-4a8a-8db1-6afc973cb0f0 41163-040 HUMAN OTC DRUG equaline first aid antibiotic Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20150402 OTC MONOGRAPH FINAL part333B Supervalu Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 41163-041_aac8e4ee-9ea1-4cbd-8401-eb523e220dd4 41163-041 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20150706 OTC MONOGRAPH FINAL part333D Supervalu Inc. SALICYLIC ACID 19.8 mg/g N 20181231 41163-043_33931e48-4cd3-4c40-a139-c9b56ab856ad 41163-043 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20090913 OTC MONOGRAPH FINAL part355 SUPERVALU INC SODIUM FLUORIDE .1 mg/mL N 20181231 41163-045_e50f6a1c-9440-4405-9cee-783ec0697a04 41163-045 HUMAN OTC DRUG childrens acetaminophen acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 160 mg/1 N 20181231 41163-047_6af1921f-4109-4677-81c9-c744b37afd50 41163-047 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 41163-050_0bfa311b-e2d3-48d2-a361-1c7488bbb8ab 41163-050 HUMAN OTC DRUG equaline ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, FILM COATED ORAL 20090302 ANDA ANDA079113 Supervalu Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 41163-052_1eee11ca-a817-4ecb-bbd9-cb34a8c47a85 41163-052 HUMAN OTC DRUG Povidone Iodine povidone-iodine SOLUTION TOPICAL 20041001 OTC MONOGRAPH NOT FINAL part333A Supervalu Inc POVIDONE-IODINE .1 mg/mL E 20171231 41163-054_7a7fa9d8-c09b-4ef4-83e6-12c15b30c792 41163-054 HUMAN OTC DRUG Equaline 12 Hour Decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040810 ANDA ANDA075153 Supervalu Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 41163-055_505002d2-1dbd-4782-9d11-38010a7e8990 41163-055 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19940729 OTC MONOGRAPH NOT FINAL part356 Supervalu, INC. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41163-057_bb3ff985-9dfa-4161-8431-cb2b830ad935 41163-057 HUMAN OTC DRUG Equaline Ibuprofen ibuprofen SUSPENSION ORAL 20040907 ANDA ANDA075217 Supervalu Inc IBUPROFEN 50 mg/1.25mL N 20181231 41163-061_1dc4d665-0d33-4808-a54c-690221af6a38 41163-061 HUMAN OTC DRUG equaline nasal oxymetazoline hydrochloride SPRAY NASAL 20140715 OTC MONOGRAPH FINAL part341 Supervalu Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41163-062_9e0b9ad7-01ab-4d5c-8a1a-7390e0d89b60 41163-062 HUMAN OTC DRUG Heartburn Relief Maximum Strength Ranitidine TABLET, FILM COATED ORAL 20130615 20180715 ANDA ANDA200536 SUPERVALU INC. RANITIDINE HYDROCHLORIDE 150 mg/1 E 20171231 41163-068_aca1f647-3731-4df5-9395-b2e8b2e008c7 41163-068 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160229 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41163-069_473b36a8-de5e-465d-af5d-a7e507eb7783 41163-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20090105 OTC MONOGRAPH FINAL part347 Supervalu, Inc PETROLATUM 1 g/g N 20181231 41163-071_62327324-1157-45dd-9504-1c93998dc3ee 41163-071 HUMAN OTC DRUG Cold and Flu Relief Nighttime Multi Symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20160229 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 41163-072_555cb49b-8687-40f2-9b49-79ef38a6fd09 41163-072 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20041228 OTC MONOGRAPH NOT FINAL part356 Supervalu INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41163-073_021a2e80-e8bd-466c-8ac0-b8575073fa25 41163-073 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20050620 OTC MONOGRAPH NOT FINAL part333A Supervalu Inc ISOPROPYL ALCOHOL 500 mg/mL N 20181231 41163-075_b74d8098-66f2-4103-a26d-fab7811748b7 41163-075 HUMAN OTC DRUG equaline Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Supervalu Inc BACITRACIN ZINC 500 [iU]/g N 20181231 41163-076_71e41056-f98c-4dec-8ad2-2223a1fa6894 41163-076 HUMAN OTC DRUG equaline antibiotic plus pain relief for kids Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Supervalu Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 41163-078_be1c8983-e395-42b9-b6ed-c423ce7565a3 41163-078 HUMAN OTC DRUG Castor Oil Castor Oil LIQUID ORAL 20041216 OTC MONOGRAPH NOT FINAL part334 Supervalu, Inc CASTOR OIL 1 g/mL N 20181231 41163-080_9b37f48b-1645-43b4-9052-9600e6b7371f 41163-080 HUMAN OTC DRUG athletes foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Supervalu Inc TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 41163-081_d9429b4c-f785-45a4-8640-90b425f1acb0 41163-081 HUMAN OTC DRUG Equaline Miconazole 3 Miconazole nitrate KIT 20120116 ANDA ANDA075329 Supervalu Inc N 20181231 41163-084_616cdbee-b91b-47a7-b226-a3f1045dc994 41163-084 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20160229 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 41163-085_da729c4c-51ab-4f54-b615-7ce8bee60d5a 41163-085 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20160229 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 41163-086_fa076f0e-f1fd-4b18-ac0e-6ceb735d1570 41163-086 HUMAN OTC DRUG Hand wash Benzalkonium chloride SOAP TOPICAL 20150116 OTC MONOGRAPH NOT FINAL part333A SUPERVALU INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 41163-088_9b0f474f-9242-4997-a830-7e1430f20378 41163-088 HUMAN OTC DRUG Iodine Iodine LIQUID TOPICAL 20050204 OTC MONOGRAPH NOT FINAL part333A Supervalu Inc. IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 41163-089_30df2420-ff69-44b5-9fb2-7bdc52a64477 41163-089 HUMAN OTC DRUG equaline anti-itch Diphenhydramine hydrochloride and Zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH FINAL part348 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 41163-090_ea4b9b64-e56a-415c-bd1a-0294cc29cc7c 41163-090 HUMAN OTC DRUG equaline cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110726 OTC MONOGRAPH FINAL part341 Supervalu Inc N 20181231 41163-092_d0ef093b-92fd-48bf-9d34-5ca52b483d44 41163-092 HUMAN OTC DRUG equaline Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Supervalu Inc LORATADINE 5 mg/5mL N 20181231 41163-099_a17b5da8-ca7a-4422-9d39-02fb072bfd83 41163-099 HUMAN OTC DRUG Clear Anti Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 20050402 OTC MONOGRAPH FINAL part347 Supervalu, Inc PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 41163-100_d5e2e403-4db8-437e-bf88-d669cb9ccafb 41163-100 HUMAN OTC DRUG Equaline fluticasone propionate Fluticasone Propionate SPRAY, METERED NASAL 20160720 ANDA ANDA207957 Supervalu Inc FLUTICASONE PROPIONATE 50 ug/1 N 20191231 41163-101_c0c58736-b836-4dc0-a611-c4111be7efa4 41163-101 HUMAN OTC DRUG EQUALINE regular strength antacid Antacid TABLET, CHEWABLE ORAL 20150922 OTC MONOGRAPH FINAL part331 SUPERVALU INC CALCIUM CARBONATE 500 mg/1 N 20181231 41163-102_dc5e498a-2fcd-4a72-9510-773955d8568d 41163-102 HUMAN OTC DRUG EQUALINE extra strength antacid Antacid TABLET, CHEWABLE ORAL 20150928 OTC MONOGRAPH FINAL part331 SUPERVALU INC CALCIUM CARBONATE 750 mg/1 N 20181231 41163-104_1dc0dd33-f678-4a7e-a219-86c9842aa985 41163-104 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 19900713 20180803 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 325 mg/1 E 20171231 41163-109_0a11ee3f-b4db-47b9-ba4a-a22f1533f202 41163-109 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100330 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM 100 mg/1 N 20181231 41163-111_baa19edb-d585-451e-a536-96293f2a7688 41163-111 HUMAN OTC DRUG Oral Saline Laxative dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120716 OTC MONOGRAPH NOT FINAL part334 SuperValu, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.7; 7.2 g/15mL; g/15mL E 20171231 41163-112_4aa6fb84-6d3f-4e61-b6b7-83b0c8e4a5fb 41163-112 HUMAN OTC DRUG Nasal Decongestant Maximum Strength Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 SUPERVALU INC. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 41163-113_6d86e916-15c9-462a-8378-1adcb29f7808 41163-113 HUMAN OTC DRUG Equaline Chest Congestion Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Supervalu Inc. GUAIFENESIN 400 mg/1 N 20181231 41163-114_4a56eec8-58d6-435d-8c66-b7b6aef51c5e 41163-114 HUMAN OTC DRUG Equaline Chest Congestion Relief DM DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Supervalu Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 41163-115_74b4be71-9aac-4e2e-acbb-71e7bae73e84 41163-115 HUMAN OTC DRUG womans laxative Bisacodyl TABLET ORAL 20130412 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) BISACODYL 5 mg/1 N 20181231 41163-117_60fb1f66-985b-47c3-8896-e11bc6ab6d83 41163-117 HUMAN OTC DRUG equaline lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120521 ANDA ANDA202319 Supervalu Inc LANSOPRAZOLE 15 mg/1 N 20181231 41163-119_56346fe2-798a-4bb3-aa68-47f670c44f2d 41163-119 HUMAN OTC DRUG Equaline Night Time Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140307 OTC MONOGRAPH FINAL part338 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41163-120_a8883382-d986-438b-8110-decf112f7316 41163-120 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100824 ANDA ANDA078682 SuperValu (Equaline) IBUPROFEN 200 mg/1 E 20171231 41163-121_3ab1de8e-98cb-46e9-b6a2-9ad20bf1a9a5 41163-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100708 ANDA ANDA078682 SuperValu (Equaline) IBUPROFEN 200 mg/1 E 20171231 41163-122_93bbffc3-54a3-4374-815e-e2b3d60b3291 41163-122 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100709 ANDA ANDA078682 SuperValu (Equaline) IBUPROFEN 200 mg/1 E 20171231 41163-135_f0172dd4-cfd3-4147-bbbf-a9b3f9675b1a 41163-135 HUMAN OTC DRUG Salicylic acid Medicated Callus Removers Extra Thick PATCH TOPICAL 20171227 OTC MONOGRAPH FINAL part358F SUPERVALU INC. SALICYLIC ACID 40 mg/41 N 20181231 41163-136_c0a4210a-26dd-4874-9124-aec326660030 41163-136 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20171227 OTC MONOGRAPH FINAL part358F SUPERVALU INC SALICYLIC ACID 40 mg/91 N 20181231 41163-139_21112d81-e38e-4f41-9ea1-430f2bd46436 41163-139 HUMAN OTC DRUG Laxative maximum strength Sennosides TABLET ORAL 20100823 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) SENNOSIDES 25 mg/1 N 20181231 41163-146_26863120-ebc0-4147-8512-06924f2096ee 41163-146 HUMAN OTC DRUG equaline stomach relief Bismuth subsalicylate SUSPENSION ORAL 20041014 OTC MONOGRAPH FINAL part335 Supervalu Inc BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 41163-153_09baa078-07ed-4686-b19c-e352bfe6c1f5 41163-153 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20061026 OTC MONOGRAPH FINAL part358H SUPERVALU INC. PYRITHIONE ZINC 10 mg/mL N 20181231 41163-154_ad1768a9-adf6-4d17-9c19-0e3d5e5f405b 41163-154 HUMAN OTC DRUG equaline athletes foot tolnaftate SPRAY TOPICAL 20040911 OTC MONOGRAPH FINAL part333C Supervalu Inc TOLNAFTATE 1 g/100g N 20181231 41163-157_260e5d82-db25-4ba9-8a66-c459fbf30250 41163-157 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 20060210 20201207 OTC MONOGRAPH FINAL part343 SUPERVALU INC. ASPIRIN 325 mg/1 N 20191231 41163-158_06dcece5-0fdc-4ff1-a8b1-fadb503a9f50 41163-158 HUMAN OTC DRUG Equaline congestion relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20150717 ANDA ANDA203200 Supervalu Inc IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20181231 41163-159_0ca4384c-ebcb-48d4-ba48-5defc3d91ee6 41163-159 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 41163-160_45d835b1-fb35-475a-909c-682d29ea3575 41163-160 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20130315 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 41163-163_6f491cd1-adab-4958-ad60-126589422064 41163-163 HUMAN OTC DRUG EQUALINE TRICLOSAN LIQUID TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC. TRICLOSAN .46 mg/100mL N 20181231 41163-163_db1dcc82-960e-4390-b951-bd0a3b81b550 41163-163 HUMAN OTC DRUG EQUALINE TRICLOSAN LIQUID TOPICAL 20120626 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC. TRICLOSAN .46 mg/100mL N 20181231 41163-164_a5ed28ed-0563-45b3-b2df-12c7bf90c8bc 41163-164 HUMAN OTC DRUG Head Congestion Daytime and Nighttime Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 SUPERVALU INC. N 20181231 41163-165_4718aacc-826e-4ea6-aa4f-affad8b62a75 41163-165 HUMAN OTC DRUG Loratadine and Pseudoephedrine Loratadine and Pseudoephedrine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 SUPERVALU INC. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 41163-166_8fef5d64-6f5c-4df7-b15e-66af4b121cc1 41163-166 HUMAN OTC DRUG Equaline ibuprofen childrens Ibuprofen SUSPENSION ORAL 20041007 ANDA ANDA074937 Supervalu Inc IBUPROFEN 100 mg/5mL N 20181231 41163-167_90265a1c-e61a-4503-8513-72604acdcfb7 41163-167 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20130509 ANDA ANDA079096 EQUALINE (SuperValu) NAPROXEN SODIUM 220 mg/1 N 20181231 41163-168_47615278-e8d5-48f7-a6fd-7f325101b198 41163-168 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111024 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC TRICLOSAN .6 mL/100mL N 20181231 41163-169_aa033b1d-509c-44a1-ad49-967c6c241d3e 41163-169 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20101115 ANDA ANDA079096 SuperValu (Equaline) NAPROXEN SODIUM 220 mg/1 N 20181231 41163-170_43db69f5-73a7-4006-92d0-414b02d10013 41163-170 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080908 ANDA ANDA076789 Supervalu Inc NICOTINE 4 mg/1 N 20181231 41163-172_3b4b86f9-eba1-532e-e054-00144ff88e88 41163-172 HUMAN OTC DRUG Pressure and Pain PE plus Cough ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20140801 OTC MONOGRAPH FINAL part341 SuperValu Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41163-173_7903c509-42a8-48f0-99a1-b597f4f0eba3 41163-173 HUMAN OTC DRUG equaline lice solution Piperonyl Butoxide, Pyrethrum Extract KIT 20070929 OTC MONOGRAPH FINAL part358G Supervalu Inc N 20181231 41163-174_adcaac84-6cf2-487a-a17c-d1672a29d5cf 41163-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA021920 EQUALINE (SuperValu) NAPROXEN SODIUM 220 mg/1 N 20181231 41163-176_ecb2be3a-8c35-44b7-9c16-347b785071f6 41163-176 HUMAN OTC DRUG Equaline All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080730 ANDA ANDA077170 Supervalu Inc CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 41163-177_4574b0e9-f8a3-44fc-b0a9-6d6d7344a674 41163-177 HUMAN OTC DRUG EQUALINE TRICLOSAN LIQUID TOPICAL 20120626 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC. TRICLOSAN .46 mg/100mL N 20181231 41163-179_e35daffe-a98f-472d-a108-64822958712e 41163-179 HUMAN OTC DRUG equaline antacid Calcium carbonate TABLET, CHEWABLE ORAL 20041028 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 750 mg/1 N 20181231 41163-181_125b1621-0807-404f-acd2-44cb1eff4f4b 41163-181 HUMAN OTC DRUG Senna laxative Natural vegetable laxative SENNOSIDES TABLET ORAL 20100707 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) SENNOSIDES 8.6 mg/1 N 20181231 41163-186_f62beb95-4b75-4c1a-b73b-ba35f505d29b 41163-186 HUMAN OTC DRUG Equaline Night Time Sleep Aid Diphenhydramine HCl SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part338 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 41163-188_df9c2fb6-a8ed-4b13-8c8c-5e5a8b22fbb1 41163-188 HUMAN OTC DRUG Equaline Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140110 OTC MONOGRAPH FINAL part346 Supervalu Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 41163-192_3b4b86f9-eb8d-532e-e054-00144ff88e88 41163-192 HUMAN OTC DRUG Acetaminophen Easy Tabs Extra Strength Acetaminophen TABLET, COATED ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 SuperValu Inc. ACETAMINOPHEN 500 mg/1 N 20181231 41163-194_7dae98f7-e356-4c80-b0ba-2f77aa49a219 41163-194 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 SUPERVALU INC. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 41163-195_fbb1405a-1972-405c-bc29-669cba73f14f 41163-195 HUMAN OTC DRUG Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20130331 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) BISACODYL 5 mg/1 N 20181231 41163-198_40dddb85-0f84-43f8-8837-345e592bf64e 41163-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120110 ANDA ANDA078682 EQUALINE (SuperValu) IBUPROFEN 200 mg/1 N 20181231 41163-205_0bea0d70-0b00-4188-b9ab-2d1f42092d00 41163-205 HUMAN OTC DRUG equaline athletes foot Tolnaftate SPRAY TOPICAL 20040911 OTC MONOGRAPH FINAL part333C Supervalu Inc TOLNAFTATE 1 g/100g N 20181231 41163-209_022e009e-0192-4089-86f3-4d63448e0f88 41163-209 HUMAN OTC DRUG equaline first aid antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20141124 OTC MONOGRAPH FINAL part333B Supervalu Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 41163-213_bb2f4e5d-6f3c-4b06-a191-9ab0b332844a 41163-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20090514 OTC MONOGRAPH FINAL part355 Supervalu, Inc SODIUM FLUORIDE .05 kg/100L N 20181231 41163-214_dc645f2b-1c15-4134-8f4e-100d8441ac8c 41163-214 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20130325 OTC MONOGRAPH FINAL part338 SuperValu (Equaline) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41163-220_42467a18-a347-4713-91cd-f9e7fcf5883e 41163-220 HUMAN OTC DRUG Equaline Liquid TRICLOSAN SOAP TOPICAL 20110404 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC TRICLOSAN .15 mL/100mL N 20181231 41163-220_890909af-20ed-4e5a-aba6-43a36402b7f4 41163-220 HUMAN OTC DRUG Equaline Liquid TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Supervalu Inc TRICLOSAN .15 mL/100mL N 20181231 41163-226_b31df507-da2b-4ce9-9704-3db08c1f3d9f 41163-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 SUPERVALU INC. CAFFEINE 200 mg/1 N 20181231 41163-228_7ca82728-3f13-40e8-9c72-85b43bd70754 41163-228 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20140829 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41163-229_bfd1fc86-645d-4275-ae8d-6a9b81624dc1 41163-229 HUMAN OTC DRUG Pain Relief PM extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20120919 OTC MONOGRAPH FINAL part338 EQUALINE (SuperValu) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41163-230_eaf1a48a-5533-4427-9189-c5c5a36a7d98 41163-230 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20120103 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 41163-235_e56dba15-107f-4992-9849-35bb6b28659d 41163-235 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 20180511 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 41163-236_a3171885-21bc-4537-99bf-d52d1fba86ae 41163-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 41163-238_967f08db-7333-47b2-949c-5eae5eb0beb1 41163-238 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20141130 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM 100 mg/1 N 20181231 41163-242_6e9b64ab-c76f-4d5e-ba09-2aa09a30ff2a 41163-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part347 EQUALINE (SuperValu) DIMETHICONE 125 mg/1 N 20181231 41163-244_accc79cd-e5c7-414b-a080-906e74396e37 41163-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM 100 mg/1 N 20181231 41163-245_50b66cc2-3343-4049-81fe-c6280e13beae 41163-245 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET ORAL 20141231 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) SENNOSIDES 25 mg/1 N 20181231 41163-246_1ad59b63-e920-4a2c-965b-b62dbf2b052a 41163-246 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20131030 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41163-251_602c529d-16eb-5011-e053-2a91aa0a0295 41163-251 HUMAN OTC DRUG EQUALINE TOLNAFTATE ANTIFUNGAL TOLNAFTATE CREAM TOPICAL 20110928 OTC MONOGRAPH FINAL part333C SUPERVALU INC TOLNAFTATE 10 mg/g N 20181231 41163-253_f569bd8f-3932-4c99-90b4-3fc20ef37aac 41163-253 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20150121 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 10 mg/mL N 20181231 41163-254_81139027-c67e-4ee8-8f7b-68baf93fb985 41163-254 HUMAN OTC DRUG equaline triple antibiotic plus bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Supervalu Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 41163-255_91eb2488-59e7-456a-97e6-2d69b3f1ad03 41163-255 HUMAN OTC DRUG equaline ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20041222 ANDA ANDA075217 Supervalu Inc IBUPROFEN 50 mg/1.25mL N 20181231 41163-258_f3d9bd62-9c38-40c1-a16b-c6c6eb4aef9a 41163-258 HUMAN OTC DRUG EQUALINE ETHYL ALCOHOL LIQUID TOPICAL 20120626 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC. ALCOHOL 62 mL/100mL N 20181231 41163-259_4f5d8063-a4e7-48e1-b380-23970fc3e448 41163-259 HUMAN OTC DRUG EQUALINE ETHYL ALCOHOL LIQUID TOPICAL 20120626 OTC MONOGRAPH NOT FINAL part333E SUPERVALU INC. ALCOHOL 62 mL/100mL N 20181231 41163-263_11a27eb5-01a4-420e-a934-7d0c1e9cc979 41163-263 HUMAN OTC DRUG Pre-moistened Hemorrhoidal Pads witch hazel SOLUTION TOPICAL 20041001 OTC MONOGRAPH FINAL part346 Supervalu Inc WITCH HAZEL .5 mL/mL N 20181231 41163-264_602cb0ae-4375-7ac2-e053-2a91aa0a60b6 41163-264 HUMAN OTC DRUG EQUALINE CLOTRIMAZOLE ANTIFUNGAL CLOTRIMAZOLE CREAM TOPICAL 20110929 OTC MONOGRAPH FINAL part333C SUPERVALU INC CLOTRIMAZOLE 1 g/100g N 20181231 41163-269_56063d06-29aa-4230-b273-1b161842e257 41163-269 HUMAN OTC DRUG equaline daytime severe cold fast relief nighttime cold and flu fast relief Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, doxylamine succinate KIT 20170712 OTC MONOGRAPH FINAL part341 Supervalu Inc N 20181231 41163-278_21923044-4703-4d11-9f33-a12b9a605f13 41163-278 HUMAN OTC DRUG Light Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333A SUPERVALU INC BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 41163-279_13442125-4240-4b9a-9f67-49135b5fed60 41163-279 HUMAN OTC DRUG Equaline Hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140905 OTC MONOGRAPH FINAL part346 Supervalu Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 41163-291_dc383702-44c9-4209-8fd6-f461fcce5c38 41163-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 SUPERVALU INC. IBUPROFEN 200 mg/1 N 20181231 41163-294_2baaedea-ef4e-48b2-804d-a6b4ea7331a6 41163-294 HUMAN OTC DRUG equaline hair regrowth treatment for men Minoxidil AEROSOL, FOAM TOPICAL 20120313 ANDA ANDA091344 Supervalu Inc MINOXIDIL 5 g/100g N 20181231 41163-296_669840ec-f13d-4208-8dc4-19b6e7fda9f7 41163-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20150119 OTC MONOGRAPH FINAL part358H SUPERVALU, INC PYRITHIONE ZINC 10 mg/mL N 20181231 41163-299_f1aa5b28-6563-42f5-bd65-e2250296f70f 41163-299 HUMAN OTC DRUG Equaline Multi-Action Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20070501 OTC MONOGRAPH NOT FINAL part356 Supervalu, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 41163-300_dc74aaab-8590-41d2-8dd3-8bbfa6e6c9e4 41163-300 HUMAN OTC DRUG Equaline tussin cough Dextromethorphan Hydrobromide LIQUID ORAL 20040921 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL N 20181231 41163-301_0099b5b2-aea0-476e-8692-b13d181f8397 41163-301 HUMAN OTC DRUG equaline antacid calcium carbonate TABLET, CHEWABLE ORAL 20160413 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 750 mg/1 N 20181231 41163-304_0ff3a5c5-575a-42a8-96e1-c40125487b13 41163-304 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 SUPERVALU INC. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 41163-306_9d3da7a7-d53e-4c71-b680-1164fe811968 41163-306 HUMAN OTC DRUG equaline clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Supervalu Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 41163-309_01798c27-b881-468f-be97-7d9442f4eba8 41163-309 HUMAN OTC DRUG Equaline nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170531 ANDA ANDA206393 Supervalu Inc NICOTINE 4 mg/1 N 20181231 41163-313_18470360-e28c-4692-a9d7-63d79603985a 41163-313 HUMAN OTC DRUG equaline heartburn prevention Famotidine TABLET ORAL 20090918 ANDA ANDA075400 Supervalu Inc FAMOTIDINE 10 mg/1 N 20181231 41163-318_83ad4ae8-a29e-4a61-95cc-e1868101fc09 41163-318 HUMAN OTC DRUG Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 20050104 OTC MONOGRAPH NOT FINAL part356 Supervalu Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41163-319_92ef6396-00b4-4b89-80ad-33152b78b4e7 41163-319 HUMAN OTC DRUG equaline anti itch Hydrocortisone CREAM TOPICAL 20101117 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc HYDROCORTISONE 1 g/100g N 20181231 41163-320_3d8cd58b-d760-4ffd-b39c-615c64d5d93d 41163-320 HUMAN OTC DRUG DAILY MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL DIMETHICONE LOTION TOPICAL 20100721 OTC MONOGRAPH FINAL part347 SUPERVALU INC DIMETHICONE 1.25 mL/100mL N 20181231 41163-320_d2cd35fc-2c0f-4f89-b1a7-477813ceea23 41163-320 HUMAN OTC DRUG DAILY MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 SUPERVALU INC DIMETHICONE 1.25 mL/100mL N 20181231 41163-321_7990fa83-438a-407c-9a47-b25f9b00eaae 41163-321 HUMAN OTC DRUG equaline complete dual action famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080902 ANDA ANDA077355 Supervalu Inc FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 41163-323_19212a3f-c18f-4287-867f-592a84f3ed92 41163-323 HUMAN OTC DRUG equaline naproxen sodium Naproxen sodium TABLET, FILM COATED ORAL 20140714 ANDA ANDA074661 Supervalu Inc NAPROXEN SODIUM 220 mg/1 N 20181231 41163-325_372251fb-3380-4620-8d8b-8e98fe9f6f9a 41163-325 HUMAN OTC DRUG Equaline Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160703 ANDA ANDA091009 Supervalu Inc GUAIFENESIN 1200 mg/1 N 20181231 41163-326_58865b21-59a8-4957-bfa1-e384a4328c96 41163-326 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20000901 20181214 OTC MONOGRAPH NOT FINAL part334 SUPERVALU INC. BISACODYL 5 mg/1 E 20171231 41163-329_4a3e7d9c-fa42-4a50-8bac-9d0bd326a34c 41163-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, FILM COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 SUPERVALU INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 41163-332_ee712d2b-871b-471c-802b-09160e5aaac1 41163-332 HUMAN OTC DRUG Equaline milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20041014 OTC MONOGRAPH NOT FINAL part334 Supervalu Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 41163-333_4ee4019f-504c-4cdb-931f-c3f5544d35e0 41163-333 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041122 ANDA ANDA076200 SUPERVALU INC. ACETAMINOPHEN 650 mg/1 N 20181231 41163-335_0b8e0c20-403c-422b-bc12-1996db2b1202 41163-335 HUMAN OTC DRUG equaline nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20111017 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 41163-336_858cc5c1-fa49-4d6b-98b4-608d507d03a2 41163-336 HUMAN OTC DRUG Acetaminophen 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130813 ANDA ANDA076200 Supervalu Inc. ACETAMINOPHEN 650 mg/1 N 20181231 41163-341_a34dbb6f-962d-4e8d-a2f9-b0acb953ef54 41163-341 HUMAN OTC DRUG equaline athletes foot Miconazole Nitrate SPRAY TOPICAL 20040911 OTC MONOGRAPH FINAL part333C Supervalu Inc MICONAZOLE NITRATE 2 g/100g N 20181231 41163-343_d7fa1720-eac4-4e82-9401-77215ce4f545 41163-343 HUMAN OTC DRUG Equaline Nasal Oxymetazoline hydrochloride SPRAY NASAL 20160703 OTC MONOGRAPH FINAL part341 Supervalu Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41163-344_6b17d752-fbe6-4cb2-bb72-247e90e74cfd 41163-344 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex LOZENGE ORAL 20060328 ANDA ANDA077007 Supervalu Inc NICOTINE 2 mg/1 N 20181231 41163-346_b6f74c6a-8caa-44de-befb-c7af9a33ab60 41163-346 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate TABLET ORAL 20110506 OTC MONOGRAPH FINAL part335 SUPERVALU INC. BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 41163-351_b15d3c38-c3b9-4830-9e4e-7eee66b3b782 41163-351 HUMAN OTC DRUG Equaline Ranitidine TABLET ORAL 20110628 ANDA ANDA200536 Supervalu Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 41163-352_c275b91c-43bc-45a9-9329-3a6822e283e3 41163-352 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080917 ANDA ANDA078547 Supervalu Inc NICOTINE 2 mg/1 N 20181231 41163-353_930809af-be1c-4913-9fcb-36d7c4716d5e 41163-353 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Supervalu Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 41163-356_fb0e0184-b1b7-4bfb-82bb-e3a13e8a4354 41163-356 HUMAN OTC DRUG EQUALINE ALL DAY MOISTURIZER OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 SUPERVALU INC. OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE 50; 30; 30; 26 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41163-357_0b4e392b-9504-48b2-ac05-dd973402264f 41163-357 HUMAN OTC DRUG Equaline Antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20041027 OTC MONOGRAPH FINAL part331 Supervalu Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 41163-358_d87439aa-11fa-4cf6-b878-1a41f49e27cf 41163-358 HUMAN OTC DRUG EQUALINE DIMETHICONE LOTION TOPICAL 20130115 OTC MONOGRAPH FINAL part347 SUPERVALU INC. DIMETHICONE 13 mg/mL N 20181231 41163-358_f930ddf1-1c2e-4c47-90e5-651dfa9f9b00 41163-358 HUMAN OTC DRUG EQUALINE DIMETHICONE LOTION TOPICAL 20130115 OTC MONOGRAPH FINAL part347 SUPERVALU INC. DIMETHICONE 13 mg/mL N 20181231 41163-359_fca59e84-b2b2-4a5e-9d0c-814ab47c6245 41163-359 HUMAN OTC DRUG Equaline tussin adult Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20040824 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 41163-363_d418c676-03c3-4031-bbf4-8bf908d10e4c 41163-363 HUMAN OTC DRUG equaline acetaminophen Acetaminophen TABLET ORAL 20170829 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 500 mg/1 N 20181231 41163-367_75b31334-181f-4890-ba05-8080b165d809 41163-367 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 SUPERVALU INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41163-368_c865bd73-eb89-4d25-b88c-214867c8f715 41163-368 HUMAN OTC DRUG equaline all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20040810 ANDA ANDA074661 Supervalu Inc NAPROXEN SODIUM 220 mg/1 N 20181231 41163-369_e67b5342-8bc5-4258-9d14-6a4b87f60f16 41163-369 HUMAN OTC DRUG equaline anti itch maximum strength Hydrocortisone CREAM TOPICAL 20110225 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc HYDROCORTISONE 1 g/100g N 20181231 41163-370_ab5e917d-068b-4a59-b16d-aa447e92470b 41163-370 HUMAN OTC DRUG Aspirin regular strength Aspirin TABLET, COATED ORAL 20111205 OTC MONOGRAPH FINAL part343 SuperValu (Equaline) ASPIRIN 325 mg/1 N 20181231 41163-373_a0594096-d7a2-464e-beb4-370e687ac496 41163-373 HUMAN OTC DRUG Headache Formula PM Acetaminophen and Diphenhydramine Citrate TABLET, FILM COATED ORAL 20040607 20200217 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 N 20181231 41163-374_8c7e73a1-8291-4c5d-9460-1e902874e1a5 41163-374 HUMAN OTC DRUG Equaline migraine formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20040903 ANDA ANDA075794 Supervalu Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 41163-375_7f9541f3-3ebd-4c5d-8f61-988fac070bf5 41163-375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 SUPERVALU INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 41163-379_3a758ede-465e-4989-9474-eb2ba6a33de2 41163-379 HUMAN OTC DRUG equaline allergy Diphenhydramine HCl SOLUTION ORAL 20040810 OTC MONOGRAPH FINAL part341 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 41163-380_51e08544-a9d0-4d17-b65e-fec0069e696b 41163-380 HUMAN OTC DRUG Magnesium Citrate Magnesium Citrate LIQUID ORAL 20110923 OTC MONOGRAPH NOT FINAL part334 Supervalu, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 41163-381_2f33c793-bc09-4595-a981-abdd1d106d7f 41163-381 HUMAN OTC DRUG Equaline Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20131212 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41163-384_d4229c6c-e1b2-4794-be97-7d158e63100b 41163-384 HUMAN OTC DRUG equaline cough dm dextromethorphan polistirex SUSPENSION ORAL 20121019 ANDA ANDA091135 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 41163-386_36ff773d-3a37-49b3-912e-a5e9b0c44956 41163-386 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 SUPERVALU INC. DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 41163-388_ef5835b5-cfad-4747-ba40-a6860ed91b5a 41163-388 HUMAN OTC DRUG equaline tussin multi symptom Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20140711 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 41163-390_627a31e9-ccd1-4d2c-b875-0d16cbb6f169 41163-390 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET, FILM COATED ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20191231 41163-392_1f52c4e6-536a-4fd5-b7a2-aa7e529df2ce 41163-392 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 SUPERVALU INC. IBUPROFEN 200 mg/1 N 20181231 41163-393_782283e5-e39c-47f7-85c2-486274f74a22 41163-393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19990301 ANDA ANDA075139 SUPERVALU INC. IBUPROFEN 200 mg/1 N 20181231 41163-396_8a03df82-d06a-4975-b907-9970c84c062d 41163-396 HUMAN OTC DRUG equaline milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20041014 OTC MONOGRAPH NOT FINAL part334 Supervalu Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 41163-397_a93691bb-447b-48e0-9631-2e348b212fa6 41163-397 HUMAN OTC DRUG Chewable Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20010904 20190228 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ASPIRIN 81 mg/1 N 20191231 41163-401_d5ef6eba-86d0-4257-8b14-e2aac190d9b6 41163-401 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET ORAL 20121031 OTC MONOGRAPH FINAL part336 SuperValu (Equaline) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41163-404_4aaf4911-df59-4085-9566-49ee73bca29b 41163-404 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET, CHEWABLE ORAL 20020529 20190317 OTC MONOGRAPH FINAL part336 SUPERVALU INC. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 41163-407_cdd6eec0-acfc-4f29-8cf6-90a70c5bec98 41163-407 HUMAN OTC DRUG Equaline Cold Sore Treatment Camphor CREAM TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 41163-411_3e416db0-c344-43a9-8611-72b215758cb0 41163-411 HUMAN OTC DRUG Cough and Cold Relief HBP Chlorpheniramine maleate and Dextromethorphan HBr TABLET, SUGAR COATED ORAL 20030503 20200606 OTC MONOGRAPH FINAL part341 SUPERVALU INC. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 41163-412_edf7a703-e3c5-4158-943f-5a5550b48679 41163-412 HUMAN OTC DRUG EQUALINE MEDICATED WIPES WITCH HAZEL CLOTH TOPICAL 20111003 OTC MONOGRAPH FINAL part346 SUPERVALU INC WITCH HAZEL 5 g/1 N 20181231 41163-413_09a9a26f-f8a8-4372-bd5b-642575cb731c 41163-413 HUMAN OTC DRUG Equaline Dandruff Classic Clean PYRITHIONE ZINC SHAMPOO TOPICAL 20100916 OTC MONOGRAPH FINAL part358H Supervalu Inc PYRITHIONE ZINC 1 mL/100mL N 20181231 41163-413_c3af3961-c506-4fd9-9729-acc8e065728c 41163-413 HUMAN OTC DRUG Equaline Dandruff Classic Clean PYRITHIONE ZINC SHAMPOO TOPICAL 20100916 OTC MONOGRAPH FINAL part358H Supervalu Inc PYRITHIONE ZINC 1 mL/100mL N 20181231 41163-414_7643aa74-be93-4bb7-8fe9-327cd195bf2f 41163-414 HUMAN OTC DRUG Adult Low strength Aspirin Aspirin TABLET, COATED ORAL 20040114 20180310 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ASPIRIN 81 mg/1 E 20171231 41163-415_d4a2280d-e31e-47a0-b130-30c9b253eaf3 41163-415 HUMAN OTC DRUG CLASSIC CLEAN 2 IN 1 FOR NORMAL HAIR PYRITHIONE ZINC SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 1 mL/100mL N 20181231 41163-416_2f02d99f-a5ad-420d-aee9-4c072386b904 41163-416 HUMAN OTC DRUG Equaline Aspirin Aspirin TABLET ORAL 20040813 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ASPIRIN 325 mg/1 N 20181231 41163-417_020dffaa-e604-4bcc-aed6-cbe8cf088049 41163-417 HUMAN OTC DRUG EQUALINE CLASSIC CLEAN 2 IN 1 PYRITHIONE ZINC LIQUID TOPICAL 20130214 OTC MONOGRAPH FINAL part358H SUPERVALU INC. PYRITHIONE ZINC 10 mg/mL N 20181231 41163-418_7a9624ff-65e7-4cbb-bc3f-cea0a6dfc521 41163-418 HUMAN OTC DRUG Equaline Dandruff Dry Scalp 2 in 1 PYRITHIONE ZINC SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 1 mL/100mL N 20181231 41163-420_e961aac9-c831-49b1-ba12-71389e191175 41163-420 HUMAN OTC DRUG OCEAN BREEZE 2 IN 1 DANDRUFF SEA MINERAL SCENT PYRITHIONE ZINC SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 1 mL/100mL N 20181231 41163-423_c2c4e7fa-7f12-4b28-9afc-e99076de098d 41163-423 HUMAN OTC DRUG Equaline Dandruff Refresh PYRITHIONE ZINC SHAMPOO TOPICAL 20100916 OTC MONOGRAPH FINAL part358H Supervalu Inc PYRITHIONE ZINC 1 mL/100mL N 20181231 41163-424_c0db6811-124a-417c-87c5-2c13130c1a99 41163-424 HUMAN OTC DRUG EQUALINE CLASSIC CLEAN 2 IN 1 PYRITHIONE ZINC LIQUID TOPICAL 20140226 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 10 mg/mL N 20181231 41163-425_5c8348b6-2fcc-4e02-8dfb-6f7eb9b1b329 41163-425 HUMAN OTC DRUG EQUALINE DRY SCALP 2 IN 1 PYRITHIONE ZINE LIQUID TOPICAL 20140731 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 10 mg/mL N 20181231 41163-426_b3ac6c07-a06e-43eb-83ed-379a8a0ce200 41163-426 HUMAN OTC DRUG Childrens allergy relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Supervalu Inc LORATADINE 5 mg/5mL N 20181231 41163-427_26c313b9-fd6b-4e2f-96f7-70a2707faf89 41163-427 HUMAN OTC DRUG EQUALINE CLASSIC CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20131231 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 10 mg/mL N 20181231 41163-427_946dd410-4a62-4489-8dd4-8ba6886df51c 41163-427 HUMAN OTC DRUG EQUALINE CLASSIC CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20140731 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 10 mg/mL N 20181231 41163-428_e5fd551a-2e51-47bd-a52e-abdf91260a04 41163-428 HUMAN OTC DRUG equaline antibiotic plus pain relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Supervalu Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 41163-432_426cdcf9-bdcc-4e60-a5b3-112871c01fce 41163-432 HUMAN OTC DRUG equaline nasal decongestant non drowsy maximum strength Pseudoephedrine HCl TABLET, FILM COATED ORAL 20040817 OTC MONOGRAPH FINAL part341 Supervalu Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 41163-434_99cdefe7-a08e-401b-aa04-ffa5a470fce1 41163-434 HUMAN OTC DRUG Stay Awake Maximum Strength Caffeine TABLET, FILM COATED ORAL 19980414 OTC MONOGRAPH FINAL part340 SUPERVALU INC. CAFFEINE 200 mg/1 N 20191231 41163-435_2732403e-73d9-674e-e054-00144ff88e88 41163-435 HUMAN OTC DRUG Essential Everyday Antibacterial Citrus Scent Antibacterial Hand and Face Wipes SWAB TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A SUPERVALU INC BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 41163-436_272fc10f-aa7e-081a-e054-00144ff8d46c 41163-436 HUMAN OTC DRUG Essential Everyday Antibacterial Moist Wipes Antibacterial Moist Wipes SWAB TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Supervalu inc BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 41163-439_05c5e175-ab88-4423-b8ea-c85341cfb105 41163-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333A Supervalu Inc ALCOHOL 700 mg/mL N 20181231 41163-443_776e5bf3-b244-4073-933c-abc3a0cb5086 41163-443 HUMAN OTC DRUG Equaline nasal allergy Triamcinolone acetonide SPRAY, METERED NASAL 20161229 ANDA ANDA078104 Supervalu Inc TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 41163-449_c9ec4ad8-e22b-455a-ab13-ff9ebcf0f680 41163-449 HUMAN OTC DRUG Acetaminophen junior strength Acetaminophen TABLET, CHEWABLE ORAL 20050128 20200213 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 160 mg/1 N 20181231 41163-450_638cb598-e320-444c-9cf6-985cee5e330e 41163-450 HUMAN OTC DRUG Acetaminophen Junior Strength Acetaminophen TABLET, CHEWABLE ORAL 20050225 20200810 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 160 mg/1 N 20181231 41163-453_2d2e28cf-32d5-4701-9a89-1f56df0ecfd9 41163-453 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 SUPERVALU INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 41163-456_ee6408f1-e8ba-4080-9891-e84cd0385bec 41163-456 HUMAN OTC DRUG Equaline Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080917 ANDA ANDA076777 Supervalu Inc NICOTINE 2 mg/1 N 20181231 41163-458_832252e5-1935-4da8-b15b-3bf00bf3ddf4 41163-458 HUMAN OTC DRUG Equaline all day allergy Cetirizine Hydrochloride TABLET ORAL 20080123 ANDA ANDA078336 Supervalu Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 41163-459_4a4e63de-42c6-4166-a936-5a48be953322 41163-459 HUMAN OTC DRUG equaline nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20111024 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 41163-468_f39bd219-9825-460b-a3ee-ee96fdaa2989 41163-468 HUMAN OTC DRUG equaline antacid Calcium carbonate TABLET, CHEWABLE ORAL 20041014 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 750 mg/1 N 20181231 41163-470_e937fd1b-4c97-4b8c-a993-6a4a985d33b8 41163-470 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41163-471_23516c0a-28ae-4579-a871-140f4145ed04 41163-471 HUMAN OTC DRUG equaline anti itch hydrocortisone OINTMENT TOPICAL 20101203 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc HYDROCORTISONE 1 g/100g N 20181231 41163-472_3b8601ce-3678-4190-9287-c1a714d801c8 41163-472 HUMAN OTC DRUG Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20160229 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) N 20181231 41163-473_1375644c-288d-45e2-918a-460271b2dab0 41163-473 HUMAN OTC DRUG equaline childrens acetaminophen Acetaminophen SUSPENSION ORAL 20141015 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL N 20181231 41163-475_50b52904-eda3-4401-92d4-23bf1cd34a54 41163-475 HUMAN OTC DRUG Equaline childrens all day allergy Cetirizine HCl SOLUTION ORAL 20151117 ANDA ANDA204226 Supervalu Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 41163-478_a498a5f3-10a7-48ae-829a-b923a29bb0d8 41163-478 HUMAN OTC DRUG equaline antacid regular strength calcium carbonate TABLET, CHEWABLE ORAL 20040928 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 500 mg/1 N 20181231 41163-479_d48a38e6-e85b-4c5d-8ea0-74e2c0b2f607 41163-479 HUMAN OTC DRUG equaline allergy Diphenhydramine Hydrochloride TABLET ORAL 20040830 OTC MONOGRAPH FINAL part341 Supervalu Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41163-480_a2b4a1e3-3db2-4d0d-9cbe-7319d1bf9312 41163-480 HUMAN OTC DRUG Nighttime Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 41163-485_98983baf-35bd-499b-8749-4d3988b4b370 41163-485 HUMAN OTC DRUG equaline antacid calcium carbonate TABLET, CHEWABLE ORAL 20050104 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 500 mg/1 N 20181231 41163-486_da9d1c36-2dda-4f30-b031-ec2894a4db72 41163-486 HUMAN OTC DRUG Senna laxative Sennosides TABLET ORAL 20160229 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) SENNOSIDES 8.6 mg/1 N 20181231 41163-487_8fc20191-bc4a-455d-b073-4c5c3fe7c8f2 41163-487 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part347 EQUALINE (SuperValu) DIMETHICONE 125 mg/1 N 20181231 41163-488_4025f145-dc24-488e-a079-c5ac79992cfc 41163-488 HUMAN OTC DRUG EQUALINE BLUE ICE PAIN RELIEVING MENTHOL GEL TOPICAL 20111003 OTC MONOGRAPH FINAL part348 SUPERVALU INC MENTHOL 2 g/100g E 20171231 41163-489_41c20c6d-adf3-47c8-9d1a-90205f120836 41163-489 HUMAN OTC DRUG equaline antacid Calcium carbonate TABLET, CHEWABLE ORAL 20041001 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 750 mg/1 N 20181231 41163-491_a1ffc116-aa15-4638-ac4c-71191fb7bb94 41163-491 HUMAN OTC DRUG Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140501 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) N 20181231 41163-492_98c8527f-3887-45cb-bc72-8522f8da5854 41163-492 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20160229 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) SENNOSIDES 25 mg/1 N 20181231 41163-494_f81c63ba-b3d5-4e35-8f83-cc252829f1da 41163-494 HUMAN OTC DRUG childrens acetaminophen acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 160 mg/1 N 20181231 41163-500_133695bf-b3e1-55ca-e054-00144ff8d46c 41163-500 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET, COATED ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc. ACETAMINOPHEN 500 mg/1 N 20181231 41163-501_7b4fd12b-8f62-4e68-8ac0-a8067f5b1d75 41163-501 HUMAN OTC DRUG Equaline Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20120228 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL N 20181231 41163-502_07c91d1c-1f41-4a19-83e7-c27025f8f1b9 41163-502 HUMAN OTC DRUG Sinus Headache PE Acetaminophen and Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 41163-503_9fb2c22d-ed75-4d90-a94c-0c5f5e10ad3d 41163-503 HUMAN OTC DRUG daytime severe cold multi-symptom Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 SUPERVALU INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41163-508_b46f11ca-bd09-42ba-b9d5-3953363272a4 41163-508 HUMAN OTC DRUG equaline antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160413 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 750 mg/1 N 20181231 41163-510_133695bf-b458-55ca-e054-00144ff8d46c 41163-510 HUMAN OTC DRUG Daytime Severe Cold and Flu Relief Maximum Strength ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20140801 OTC MONOGRAPH FINAL part341 Supervalu Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41163-511_1022d075-9bdf-46df-81ac-c84cb2608195 41163-511 HUMAN OTC DRUG equaline naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20140924 ANDA ANDA074661 Supervalu Inc NAPROXEN SODIUM 220 mg/1 N 20181231 41163-512_133695bf-b42f-55ca-e054-00144ff8d46c 41163-512 HUMAN OTC DRUG Pressure and Pain PE Plus Mucus ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20140801 OTC MONOGRAPH FINAL part341 Supervalu Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 41163-513_133695bf-b443-55ca-e054-00144ff8d46c 41163-513 HUMAN OTC DRUG Pressure and Pain PE Plus Cold ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20140801 OTC MONOGRAPH FINAL part341 Supervalu Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41163-514_133695bf-b3ce-55ca-e054-00144ff8d46c 41163-514 HUMAN OTC DRUG Acetaminophen Regular Strength Acetaminophen TABLET ORAL 20141101 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc. ACETAMINOPHEN 325 mg/1 N 20181231 41163-515_133695bf-b408-55ca-e054-00144ff8d46c 41163-515 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20140901 OTC MONOGRAPH FINAL part341 Supervalue Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41163-519_187349d8-85ca-47d9-b0f5-6c4fc1226ddb 41163-519 HUMAN OTC DRUG pain relief extra strength acetaminophen TABLET ORAL 20040510 20190215 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 500 mg/1 E 20171231 41163-520_133695bf-b41c-55ca-e054-00144ff8d46c 41163-520 HUMAN OTC DRUG Acetaminophen Gelcaps Extra Strength Acetaminophen TABLET, COATED ORAL 20141001 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc. ACETAMINOPHEN 500 mg/1 N 20181231 41163-521_7444a0aa-6c97-4919-ba57-368992af988e 41163-521 HUMAN OTC DRUG equaline ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20110504 ANDA ANDA076359 Supervalu Inc IBUPROFEN 100 mg/1 N 20181231 41163-522_133695bf-b3f4-55ca-e054-00144ff8d46c 41163-522 HUMAN OTC DRUG Aspirin Regular Strength Aspirin TABLET, DELAYED RELEASE ORAL 20141001 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc. ASPIRIN 325 mg/1 N 20181231 41163-526_5c942067-b8bf-49af-bde8-712d558bb304 41163-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 SUPERVALU INC. LORATADINE 10 mg/1 N 20181231 41163-527_4839951c-3999-4fa6-aad6-e1cced37d802 41163-527 HUMAN OTC DRUG Sinus Congestion and Pain Severe Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, COATED ORAL 20050806 20190317 OTC MONOGRAPH FINAL part341 SUPERVALU INC. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 41163-528_35af7285-9558-4f37-a826-594676f46763 41163-528 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20131203 ANDA ANDA077153 Supervalu Inc. LORATADINE 10 mg/1 N 20181231 41163-529_b19bca6a-ba33-4874-99c4-e9ee8e87a0db 41163-529 HUMAN OTC DRUG Daytime Cold, Nighttime Cold multi-symptom Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 SUPERVALU INC. N 20181231 41163-530_a61686a6-2196-408d-ba48-d4f460bf0bdb 41163-530 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20141130 OTC MONOGRAPH FINAL part347 EQUALINE (SuperValu) DIMETHICONE 180 mg/1 N 20181231 41163-531_20feae65-152a-452b-bdff-906a9a8f9be5 41163-531 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET ORAL 20051211 20181105 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 500 mg/1 E 20171231 41163-532_6693e099-3bd6-46e1-811c-5269f94b6552 41163-532 HUMAN OTC DRUG equaline nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080917 ANDA ANDA076779 Supervalu Inc NICOTINE 4 mg/1 N 20181231 41163-537_5cf4d99d-4fec-4c7a-8880-24ce7c3ee0e8 41163-537 HUMAN OTC DRUG Equaline mucus relief Acetaminophen, dextromethorphan HBr, Guaifenesin, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20170712 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41163-539_653be152-7629-41f5-a864-62803f6eadfb 41163-539 HUMAN OTC DRUG equaline esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170925 ANDA ANDA207193 Supervalu Inc ESOMEPRAZOLE 20 mg/1 N 20181231 41163-544_f663658b-10a3-4248-9d69-68047069ed37 41163-544 HUMAN OTC DRUG equaline arthritis Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120829 ANDA ANDA075077 Supervalu Inc ACETAMINOPHEN 650 mg/1 N 20181231 41163-546_698718ec-c855-48d7-a3d3-c3ebdafcaf6f 41163-546 HUMAN OTC DRUG equaline complete dual action Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080902 ANDA ANDA077355 Supervalu Inc FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 41163-550_58aee658-5b29-4d15-b6b8-f0d65c99e510 41163-550 HUMAN OTC DRUG Gas relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100708 OTC MONOGRAPH FINAL part332 SuperValu (Equaline) DIMETHICONE 125 mg/1 E 20171231 41163-551_75768d8f-39f3-4d4e-a251-8b2aeaf6eb55 41163-551 HUMAN OTC DRUG equaline nighttime cough relief Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20140520 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 41163-560_99b0c7cd-66a0-4909-b076-86ac00cbefef 41163-560 HUMAN OTC DRUG Multi-Symptom Daytime Cold Rapid Release Acetaminophen, Phenylephrine HCl and Dextromethorphan HBr TABLET ORAL 20080329 OTC MONOGRAPH FINAL part341 SUPERVALU INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41163-561_5b5234a6-8340-44d2-af6d-ef8307d46671 41163-561 HUMAN OTC DRUG equaline ibuprofen pm Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20120111 ANDA ANDA079113 Supervalu Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 41163-563_41653c08-7a98-4281-97bb-46d6ec0340d5 41163-563 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ASPIRIN 81 mg/1 N 20181231 41163-566_e0e41aaa-3c34-44aa-8224-6ef877b8ceb1 41163-566 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20140113 OTC MONOGRAPH FINAL part347 Supervalu Inc. PETROLATUM 1 g/g N 20181231 41163-567_84b10445-ebc4-470b-9eab-2c5faf15bb06 41163-567 HUMAN OTC DRUG equaline daytime and nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120814 OTC MONOGRAPH FINAL part341 Supervalu Inc N 20181231 41163-571_b3d8b1ac-2f7e-49c0-8b45-11e05b5ff614 41163-571 HUMAN OTC DRUG equaline aller ease fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Supervalu Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 41163-575_4b317033-1ed3-4f32-ad6a-b233b0e3c68f 41163-575 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20160205 OTC MONOGRAPH NOT FINAL part333A Supervalu, Inc BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 41163-584_cc14b368-36d1-4383-8d4e-c1f76261c88b 41163-584 HUMAN OTC DRUG Stool Softener Laxative DOCUSATE SODIUM CAPSULE ORAL 20170831 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM 100 mg/1 N 20181231 41163-585_60f33eaa-140e-4e77-b1e5-4ef95a8237f3 41163-585 HUMAN OTC DRUG allergy relief Childrens Diphenhydramine HCl TABLET, CHEWABLE ORAL 20090320 OTC MONOGRAPH FINAL part341 SUPERVALU INC. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20181231 41163-588_7bcf927f-c887-418b-bde5-ab4131aac42f 41163-588 HUMAN OTC DRUG equaline antacid Aluminum Hydroxide, Magnesium Hydroxide, Simethicone SUSPENSION ORAL 20120911 OTC MONOGRAPH FINAL part332 Supervalu Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 41163-595_209b6282-2b12-4ada-96ff-e54ae7539e2c 41163-595 HUMAN OTC DRUG Equaline antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20041022 OTC MONOGRAPH FINAL part331 Supervalu Inc CALCIUM CARBONATE 1000 mg/1 N 20191231 41163-600_d99d83ff-e8c0-4b1b-90be-9b21556f695a 41163-600 HUMAN OTC DRUG Equaline Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20041007 OTC MONOGRAPH FINAL part335 Supervalu Inc BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 41163-602_ce287c9b-07ef-431a-8fc5-2878902767a2 41163-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20050321 OTC MONOGRAPH NOT FINAL part334 Supervalu Inc. MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 41163-603_fb5ad055-db36-41bb-b736-a0ce9d18da77 41163-603 HUMAN OTC DRUG equaline daytime severe cold and flu relief acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20140728 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 41163-604_302cbb9d-6a53-4101-b9fc-ec2e993796df 41163-604 HUMAN OTC DRUG equaline ibuprofen Ibuprofen TABLET ORAL 20040805 ANDA ANDA072096 Supervalu Inc IBUPROFEN 200 mg/1 N 20181231 41163-607_c1d04ce6-4c95-4552-b72d-530bd7eaa3b6 41163-607 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET, SUGAR COATED ORAL 20130401 OTC MONOGRAPH NOT FINAL part334 SUPERVALU INC. BISACODYL 5 mg/1 N 20181231 41163-608_4502a135-e6d3-4262-969c-c4f6976848f8 41163-608 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone TABLET, CHEWABLE ORAL 20130701 OTC MONOGRAPH FINAL part332 SUPERVALU INC. DIMETHICONE 125 mg/1 N 20191231 41163-609_8f94573f-d510-474a-bf11-ad9bd40088ae 41163-609 HUMAN OTC DRUG Equaline infants acetaminophen Acetaminophen SUSPENSION ORAL 20141022 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL N 20181231 41163-610_a4694068-2e84-4840-91cb-8389f4feed63 41163-610 HUMAN OTC DRUG EQUALINE MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20100929 OTC MONOGRAPH FINAL part358H SUPERVALU INC SELENIUM SULFIDE 1 mL/100mL N 20181231 41163-611_f80715b8-43c9-4aeb-8d8d-cc5fa1162cd4 41163-611 HUMAN OTC DRUG Equaline Moisturizing Dandruff Medicated Formula Selenium Sulfide SHAMPOO TOPICAL 20101015 OTC MONOGRAPH FINAL part358H Supervalu Inc SELENIUM SULFIDE 1 mL/100mL N 20181231 41163-612_00620642-2b87-4f53-bc51-398f36e91f37 41163-612 HUMAN OTC DRUG Equaline Allergy Relief Loratadine TABLET ORAL 20050207 ANDA ANDA076301 Supervalu Inc LORATADINE 10 mg/1 N 20181231 41163-616_ec00ffdc-5f01-4a94-99ba-89fcccf0c171 41163-616 HUMAN OTC DRUG EQUALINE MOISTURIZING DANDRUFF SELENUM SULFIDE SHAMPOO TOPICAL 20120323 OTC MONOGRAPH FINAL part358H SUPERVALU INC. SELENIUM SULFIDE 1 mL/100mL N 20181231 41163-617_9c38a377-e59a-4225-bbb2-31ac5fdde1d6 41163-617 HUMAN OTC DRUG EQUALINE MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20120430 OTC MONOGRAPH FINAL part358H SUPERVALU INC. SELENIUM SULFIDE 1 mL/100mL N 20181231 41163-618_990ce740-8c8f-40bd-aa96-6d60a1eff961 41163-618 HUMAN OTC DRUG EQUALINE CLINICAL STRENGTH SELENIUM SULFIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH FINAL part358H SUPERVALU INC. SELENIUM SULFIDE 10 mg/mL N 20181231 41163-619_d28fd3d5-f8ee-4f53-815e-cb2dc7fc029f 41163-619 HUMAN OTC DRUG Heartburn Relief Ranitidine TABLET ORAL 20130615 20180715 ANDA ANDA200536 SUPERVALU INC. RANITIDINE HYDROCHLORIDE 75 mg/1 E 20171231 41163-620_96d220be-278c-4e69-b011-8a3720bb5fa2 41163-620 HUMAN OTC DRUG EQUALINE MENTHOL SELENIUM SULFIDE LIQUID TOPICAL 20130610 OTC MONOGRAPH FINAL part358H SUPERVALU INC. SELENIUM SULFIDE 10 mg/mL N 20181231 41163-621_4d835403-638b-4d50-85a1-3cc51cae857b 41163-621 HUMAN OTC DRUG EQUALINE ALOE SELENIUM SULFIDE LIQUID TOPICAL 20130610 OTC MONOGRAPH FINAL part358H SUPERVALU INC. SELENIUM SULFIDE 10 mg/mL N 20181231 41163-629_285e007a-1149-4881-b58d-f30cbcc849ca 41163-629 HUMAN OTC DRUG Stool Softener plus Stimulant Laxative Docusate sodium and Sennosides TABLET ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 41163-630_438980dd-b409-4178-8cc3-bf5b58474ca2 41163-630 HUMAN OTC DRUG equaline anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20040928 UNAPPROVED DRUG OTHER Supervalu Inc DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 41163-635_7572f0e0-047b-4074-b737-5228e76b0627 41163-635 HUMAN OTC DRUG gas relief extra strength Simethicone TABLET, CHEWABLE ORAL 20131001 OTC MONOGRAPH FINAL part332 SUPERVALU INC. DIMETHICONE 125 mg/1 N 20191231 41163-641_b350d918-3a77-4f35-9592-81ba1eb8443f 41163-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20141223 OTC MONOGRAPH NOT FINAL part333A SUPERVALU INC BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 41163-645_7b41bd9d-1648-4544-8706-130fcd86614f 41163-645 HUMAN OTC DRUG Equaline loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120206 ANDA ANDA091292 Supervalu Inc LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 41163-647_cf8fe431-7231-489d-a12f-5ca17249d2f1 41163-647 HUMAN OTC DRUG equaline ibuprofen Ibuprofen TABLET, COATED ORAL 20040817 ANDA ANDA072096 Supervalu Inc IBUPROFEN 200 mg/1 N 20181231 41163-652_f5451b8e-dbaf-478a-b1b0-76707c8b3b34 41163-652 HUMAN OTC DRUG Severe Cold PE Multi-Symptom Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED ORAL 20050621 20180521 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 E 20171231 41163-656_b72a69e4-dacc-4e33-bb5b-4fe3b3c94f0e 41163-656 HUMAN OTC DRUG equaline daytime cold and flu relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20111012 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 41163-664_72449559-e5f3-4814-83ff-315c50aa9454 41163-664 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Acetaminophen and Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 SUPERVALU INC. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 41163-666_db0d4265-6166-41f8-8bf9-1e4281a2f5dd 41163-666 HUMAN OTC DRUG sinus plus allergy PE maximum strength chlorpheniramine maleate, phenylephrine HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341 SUPERVALU INC. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 41163-667_2a092d39-a9db-4e2a-af82-f632a495c411 41163-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20011118 OTC MONOGRAPH NOT FINAL part334 Supervalue, INC MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 41163-685_5363a94e-e532-42f0-a3f8-d70e1dd13684 41163-685 HUMAN OTC DRUG Equaline Ibuprofen Ibuprofen SUSPENSION ORAL 20100927 ANDA ANDA074937 Supervalu Inc IBUPROFEN 100 mg/5mL N 20181231 41163-690_9588b6a3-40a1-49c5-bbbf-b80622535dfc 41163-690 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine HCl TABLET ORAL 20100722 OTC MONOGRAPH FINAL part336 SuperValu (Equaline) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41163-691_463ff541-98da-44d0-b5f9-d29e5a591cba 41163-691 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine HCl TABLET ORAL 20100722 OTC MONOGRAPH FINAL part336 EQUALINE (SuperValu) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41163-692_628cd685-d190-4937-9fd4-224621ef8860 41163-692 HUMAN OTC DRUG Equaline cool heat Menthol, Methyl salicylate CREAM TOPICAL 20100330 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 41163-693_dfc759e7-1bc6-4443-93b5-1cdf6c9d8063 41163-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20041209 OTC MONOGRAPH NOT FINAL part334 Supervalu, Inc MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 41163-698_e534f292-eeeb-4208-8a7e-6441dfc73c08 41163-698 HUMAN OTC DRUG cough and cold relief HBP Chlorpheniramine maleate, Dextromethorphan HBr TABLET, COATED ORAL 20170331 OTC MONOGRAPH FINAL part341 SUPERVALU INC. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 41163-701_6dd814d1-4baf-4094-93ed-d2d1422798de 41163-701 HUMAN OTC DRUG Equaline Tussin Mucus and Chest Congestion Guaifenesin SYRUP ORAL 20131006 OTC MONOGRAPH FINAL part341 Supervalu Inc GUAIFENESIN 200 mg/10mL N 20181231 41163-707_89c02e55-fa08-4001-96fc-8a01e7e74d5a 41163-707 HUMAN OTC DRUG equaline naproxen sodium Naproxen Sodium TABLET ORAL 20140924 ANDA ANDA074661 Supervalu Inc NAPROXEN SODIUM 220 mg/1 N 20181231 41163-716_24865aa9-8274-4bb6-9ad4-46c81e990e6d 41163-716 HUMAN OTC DRUG EQUALINE Oxymetazoline HCl Nasal Decongestant No Drip oxymetazoline hydrochloride SPRAY NASAL 20150612 OTC MONOGRAPH FINAL part341 SUPERVALU INC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41163-725_866dd0d5-55b2-4e0a-b5d1-0a46eecbecac 41163-725 HUMAN OTC DRUG Childrens Allergy Fexofenadine Hydrochloride SUSPENSION ORAL 20160301 ANDA ANDA203330 Supervalu Inc FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 41163-728_f0f547dd-892b-4f94-8c63-7f0b2470aa91 41163-728 HUMAN OTC DRUG Equaline Fast Acting Phenylephrine hydrochloride SPRAY NASAL 20141030 OTC MONOGRAPH FINAL part341 SUPERVALU INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL N 20181231 41163-735_631f47b7-3c43-48ed-950b-309309fa38e9 41163-735 HUMAN OTC DRUG Equaline Mucus DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160708 ANDA ANDA091070 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 41163-737_be535a56-1b95-424e-8197-566976ef2efa 41163-737 HUMAN OTC DRUG Maximum Strength Mucus Relief Cold,Flu and Sore Throat Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin ,Phenylephrine HCL LIQUID ORAL 20170907 OTC MONOGRAPH FINAL part341 SUPERVALU INC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 41163-738_3bb76952-15d8-4a36-a392-60f62b845f09 41163-738 HUMAN OTC DRUG maximum strength mucus relief severe congestion and cough dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride LIQUID ORAL 20170907 OTC MONOGRAPH FINAL part341 SuperValu Inc., DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 41163-750_8ecff6e0-0554-4785-83dd-cb9f99777a0c 41163-750 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20140503 OTC MONOGRAPH FINAL part347 Supervalu Inc DIMETHICONE 1.3 kg/100mL N 20181231 41163-751_9347389e-01bc-4366-8ad3-9d97a343765f 41163-751 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 20180709 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN 500 mg/1 E 20171231 41163-763_e621b94f-915e-462c-abde-644a39af3cc7 41163-763 HUMAN OTC DRUG equaline nighttime severe cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140731 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 41163-770_f1770b67-548b-42b0-9a3a-f16c1995b330 41163-770 HUMAN OTC DRUG Equaline Muscle Rub Menthol, Methyl salicylate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g N 20181231 41163-797_ea1097ef-3a0a-4760-bc62-068a6c22c5fb 41163-797 HUMAN OTC DRUG aspirin chewable, low dose aspirin TABLET, CHEWABLE ORAL 20010904 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ASPIRIN 81 mg/1 N 20181231 41163-798_4eb5ea23-0ba1-48ea-8d21-ab92a8da909d 41163-798 HUMAN OTC DRUG Equaline hair regrowth treatment for men Minoxidil SOLUTION TOPICAL 20091204 ANDA ANDA075598 Supervalu Inc MINOXIDIL 3 g/60mL N 20181231 41163-799_f6670902-d526-4f61-8696-ce84f59cf965 41163-799 HUMAN OTC DRUG Equaline tussin cough and chest congestion dm max Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20100727 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 41163-801_eba8423c-0dab-4572-ade4-6964c1b4e676 41163-801 HUMAN OTC DRUG Clean and Refreshing Body Wash Spring Fresh Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E Supervalu Inc. TRICLOSAN .15 mL/100mL N 20181231 41163-804_8b2c52cd-45e0-48e5-940b-d30e7665f73b 41163-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20050701 OTC MONOGRAPH NOT FINAL part333A Supervalue, Inc ISOPROPYL ALCOHOL 910 mg/mL N 20181231 41163-809_9bc05d1b-ae11-4a11-a20d-2c72c81e0646 41163-809 HUMAN OTC DRUG equaline antibiotic plus pain relief Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20120420 OTC MONOGRAPH FINAL part333B Supervalu Inc NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g N 20181231 41163-810_6459afb3-3a44-4d17-96fe-1cd9cce558f4 41163-810 HUMAN OTC DRUG Sinus and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20111207 OTC MONOGRAPH FINAL part341 EQUALINE (SuperValu) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 41163-811_601b9e34-ba39-409b-87d8-70f05190336d 41163-811 HUMAN OTC DRUG Equaline Cold and Hot Medicated Large Menthol PATCH TOPICAL 20100705 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc. MENTHOL 50 mg/1 N 20181231 41163-812_601b9e34-ba39-409b-87d8-70f05190336d 41163-812 HUMAN OTC DRUG Equaline Cold and Hot Medicated Small Menthol PATCH TOPICAL 20100705 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc. MENTHOL 50 mg/1 N 20181231 41163-816_be15441f-0dfa-455e-a45d-b55956da9cc2 41163-816 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20110406 OTC MONOGRAPH NOT FINAL part333A SuperValu, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 41163-821_5766e3c5-fda8-4967-b900-d4a17b8bcdac 41163-821 HUMAN OTC DRUG Acne Scrub Salicylic Acid GEL TOPICAL 20130226 OTC MONOGRAPH FINAL part333D Supervalu Inc SALICYLIC ACID 21 mg/mL N 20181231 41163-822_fe13cfd7-554b-483a-a8d0-32883efad2f3 41163-822 HUMAN OTC DRUG Witch Hazel Witch Hazel SOLUTION TOPICAL 20090529 OTC MONOGRAPH FINAL part347 Supervalu, Inc WITCH HAZEL 979 mg/mL N 20181231 41163-825_e6bada01-9cbe-4ccc-9f6d-5f9f73ab5410 41163-825 HUMAN OTC DRUG Equaline Miconazole 7 Miconazole nitrate CREAM VAGINAL 20041110 ANDA ANDA074760 Supervalu Inc MICONAZOLE NITRATE 2 g/100g N 20181231 41163-828_d2d024e7-1cd8-4237-b45d-bee97853ec0f 41163-828 HUMAN OTC DRUG EQUALINE SALICYLIC ACID PASTE TOPICAL 20130717 OTC MONOGRAPH FINAL part333D SUPERVALU INC. SALICYLIC ACID 20 mg/mL N 20181231 41163-831_cf690883-d7ff-4409-9177-759529af6b7d 41163-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 20041222 OTC MONOGRAPH NOT FINAL part334 Supervalu, Inc MINERAL OIL 999 mg/mL N 20181231 41163-836_55335bbf-c206-4c4f-b98d-8d619b1cba2c 41163-836 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20150123 OTC MONOGRAPH FINAL part358H SUPERVALU INC PYRITHIONE ZINC 10.3 mg/mL N 20181231 41163-837_2b87a038-fc76-4af5-94b6-39ee730f011b 41163-837 HUMAN OTC DRUG equaline pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20041022 OTC MONOGRAPH FINAL part338 Supervalu Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41163-839_7c00c557-e919-4787-922d-54f6781738e7 41163-839 HUMAN OTC DRUG equaline childrens mucus relief dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20151228 OTC MONOGRAPH FINAL part341 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 41163-843_558f17c9-80fd-4681-8a0a-d33e3f980b37 41163-843 HUMAN OTC DRUG Equaline hemorrhoidal cooling Phenylephrine HCl, Witch hazel GEL TOPICAL 20090115 OTC MONOGRAPH FINAL part346 Supervalu Inc PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g N 20181231 41163-845_d4e9a491-06cd-4b04-bd8b-19b82e36e10c 41163-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20050729 OTC MONOGRAPH FINAL part344 Supervalu Inc ISOPROPYL ALCOHOL 613 mg/mL N 20181231 41163-851_346bd42b-2a11-40da-b092-2fd2aac609ee 41163-851 HUMAN OTC DRUG equaline antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20041022 OTC MONOGRAPH FINAL part332 Supervalu Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 41163-855_1fbba563-d393-402f-bed5-2f96275ba52d 41163-855 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20170120 OTC MONOGRAPH NOT FINAL part356 Supervalu Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41163-866_cc9dca59-5cd6-4c67-bec6-cc81cb52c5d6 41163-866 HUMAN OTC DRUG equaline lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070709 OTC MONOGRAPH FINAL part358G Supervalu Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 41163-870_dc160348-3ed6-49e0-b1ff-2a4971865953 41163-870 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20130109 OTC MONOGRAPH NOT FINAL part333A Supervalu Inc ALCOHOL 70 mL/100mL N 20181231 41163-871_c50ec489-58d2-46ef-8d7d-b58df782a477 41163-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20050114 OTC MONOGRAPH NOT FINAL part333A Supervalu, Inc HYDROGEN PEROXIDE 30 mg/mL N 20181231 41163-872_28867e23-ee0e-4da4-a10c-f403f5bf3af8 41163-872 HUMAN OTC DRUG Equaline nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20120717 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 41163-873_e6eb0b9d-2fec-4ba8-ae2e-033d9edcb0cd 41163-873 HUMAN OTC DRUG Equaline nicotine Nicotine Polacrilex LOZENGE ORAL 20060328 ANDA ANDA077007 Supervalu Inc NICOTINE 4 mg/1 N 20181231 41163-876_771db891-03b6-4a5f-ba0a-7e76af51a6bb 41163-876 HUMAN OTC DRUG Rubbing Ethyl Alcohol LIQUID TOPICAL 20050803 OTC MONOGRAPH NOT FINAL part333A Supervalu, Inc ALCOHOL 610 mg/mL N 20181231 41163-878_2ff4a386-3ba8-4227-a462-f18bf05fe3cd 41163-878 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170630 OTC MONOGRAPH NOT FINAL part334 EQUALINE (SuperValu) DOCUSATE SODIUM 100 mg/1 N 20181231 41163-882_0431fc8b-8916-41ba-b9d2-af98ff1ef741 41163-882 HUMAN OTC DRUG equaline gas relief infants Simethicone EMULSION ORAL 20041023 OTC MONOGRAPH FINAL part332 Supervalu Inc DIMETHICONE 20 mg/.3mL N 20181231 41163-888_36437a05-538d-494b-be20-898874baaefb 41163-888 HUMAN OTC DRUG equaline acetaminophen infants Acetaminophen SUSPENSION ORAL 20141212 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL N 20181231 41163-897_e651283e-3310-43a2-9471-42805c038a37 41163-897 HUMAN OTC DRUG equaline ibuprofen childrens Ibuprofen SUSPENSION ORAL 20040830 ANDA ANDA074937 Supervalu Inc IBUPROFEN 100 mg/5mL N 20181231 41163-898_e617fb19-59e0-4c34-a85e-ea3c4c6825a1 41163-898 HUMAN OTC DRUG Antibacterial Body Wash Benzalkonium chloride LOTION TOPICAL 20150108 OTC MONOGRAPH NOT FINAL part333A SUPERVALUE INC BENZALKONIUM CHLORIDE 1.313 mg/mL N 20181231 41163-902_b179ee5d-8e1b-4259-8c7d-f7889389badb 41163-902 HUMAN OTC DRUG Day Time Cold Head Congestion Severe Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41163-908_51903e76-6890-4eff-a7db-963a15d2f73f 41163-908 HUMAN OTC DRUG equaline multi symptom flu and severe cold daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20160728 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 41163-915_0417c16a-6f3e-4f87-bb12-9bd0861973d5 41163-915 HUMAN OTC DRUG equaline omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080222 NDA NDA022032 Supervalu Inc OMEPRAZOLE 20 mg/1 N 20181231 41163-918_ba81a927-cd60-4636-ad4f-59768473d7f0 41163-918 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ASPIRIN 81 mg/1 N 20181231 41163-922_a0690569-4b45-430d-b748-17abcb7b19fa 41163-922 HUMAN OTC DRUG Equaline Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20131212 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41163-941_deaba9b0-3100-45d0-858f-e0d0bf02c622 41163-941 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20160315 OTC MONOGRAPH NOT FINAL part333A SUPERVALU, INC., BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 41163-942_9c7374e5-6c10-488b-b032-17c8f1dbd689 41163-942 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20150107 OTC MONOGRAPH NOT FINAL part333A SUPERVALU INC. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 41163-944_548047c5-5a22-4350-acff-c2728ba1f310 41163-944 HUMAN OTC DRUG Equaline Hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20080328 OTC MONOGRAPH FINAL part346 Supervalu Inc GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 41163-945_904543ab-39f8-47a1-a875-332d73996a83 41163-945 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ASPIRIN 81 mg/1 N 20181231 41163-947_25bb5aad-26ab-4e0b-8211-d3b73806bb58 41163-947 HUMAN OTC DRUG Oil Free Acne Wash Salicylic Acid 2% LOTION TOPICAL 20110204 OTC MONOGRAPH FINAL part333D Supervalue, Inc SALICYLIC ACID 20.6 mg/mL N 20181231 41163-949_02da3ccb-cc75-4fa4-86e6-8a08d294fc41 41163-949 HUMAN OTC DRUG equaline milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20051114 OTC MONOGRAPH NOT FINAL part334 Supervalu Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 41163-950_15d4761c-8dbf-46d4-aeba-21214c2f2af6 41163-950 HUMAN OTC DRUG equaline heartburn relief Ranitidine TABLET, FILM COATED ORAL 20120725 ANDA ANDA091429 Supervalu Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 41163-952_af621c01-5506-4643-bb5d-0e00653e16c5 41163-952 HUMAN OTC DRUG Medicated Dandruff Selenium sulfide 1% SHAMPOO TOPICAL 20150119 OTC MONOGRAPH FINAL part358H SUPERVALU INC. SELENIUM SULFIDE 10 mg/mL N 20181231 41163-955_a8d4eb78-4556-4315-815c-7f05e691b7aa 41163-955 HUMAN OTC DRUG equaline lice treatment Permethrin LOTION TOPICAL 20110128 ANDA ANDA076090 Supervalu Inc PERMETHRIN 1 mg/100mL N 20181231 41163-956_e290bf7a-f98c-4a42-b99f-dcd08adcdd6b 41163-956 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 SUPERVALU INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41163-958_61a5962d-f660-4776-8952-ae856bfebc67 41163-958 HUMAN OTC DRUG Equaline Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130715 ANDA ANDA091135 Supervalu Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 41163-964_77889e5c-45d3-4538-af0d-2a2404058fe8 41163-964 HUMAN OTC DRUG equaline flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20110726 OTC MONOGRAPH FINAL part341 Supervalu Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 41163-970_7f67c411-be95-4848-bf29-87ccbd1a8781 41163-970 HUMAN OTC DRUG Allergy relief Diphenhydramine HCl CAPSULE ORAL 20110815 OTC MONOGRAPH FINAL part336 SuperValu (Equaline) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41163-973_b9f2b8f3-504b-4afe-a569-710edd3efb63 41163-973 HUMAN OTC DRUG equaline anti itch maximum strength hydrocortisone CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part348 Supervalu Inc HYDROCORTISONE 1 g/100g N 20181231 41163-985_c96e8ec2-31d2-4a4f-b275-be6f6cc07c47 41163-985 HUMAN OTC DRUG Maximum Strength Mucus-DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 SUPERVALU INC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 41163-987_3d09a946-03f9-4c32-9bab-f2a022759ebe 41163-987 HUMAN OTC DRUG equaline childrens cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20120727 OTC MONOGRAPH FINAL part341 Supervalu Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 41163-997_0048ef41-8575-4e4a-b276-5180191eb712 41163-997 HUMAN OTC DRUG equaline childrens acetaminophen Acetaminophen SUSPENSION ORAL 20141015 OTC MONOGRAPH NOT FINAL part343 Supervalu Inc ACETAMINOPHEN 160 mg/5mL N 20181231 41167-0014_c3450798-2dad-48de-b302-e15ce5c5cf23 41167-0014 HUMAN OTC DRUG Unisom SleepMelts Nighttime Sleep-Aid Diphenhydramine Hydrochloride TABLET, CHEWABLE ORAL 20080101 OTC MONOGRAPH FINAL part338 Chattem, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41167-0031_a3e167e1-5e04-4f4c-bc82-497421209d89 41167-0031 HUMAN OTC DRUG Cortizone 10 Cooling Cream Anti-Itch Hydrocortisone CREAM TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100g N 20181231 41167-0032_af4980c7-c462-4594-a12b-eacb79c96b75 41167-0032 HUMAN OTC DRUG Cortizone 10 Easy Relief Hydrocortisone LIQUID TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/mL N 20181231 41167-0035_29c44a78-2791-4ccc-90d3-e99fd3535cd5 41167-0035 HUMAN OTC DRUG Cortizone 10 Intensive Healing hydrocortisone CREAM TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/g N 20181231 41167-0036_29c44a78-2791-4ccc-90d3-e99fd3535cd5 41167-0036 HUMAN OTC DRUG Cortizone 10 Cooling Relief Hydrocortisone GEL TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/g N 20181231 41167-0039_29c44a78-2791-4ccc-90d3-e99fd3535cd5 41167-0039 HUMAN OTC DRUG Cortizone 10 hydrocortisone CREAM TOPICAL 20070901 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/g N 20181231 41167-0040_2752fd74-773f-4852-ae8e-08169a293575 41167-0040 HUMAN OTC DRUG Unisom PM Pain Nighttime Sleep Aid and Pain Reliever Acetaminophen and Diphenhydramine Hydrochloride TABLET ORAL 20091201 OTC MONOGRAPH FINAL part338 Chattem, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 325; 50 mg/1; mg/1 N 20181231 41167-0053_e3928572-063c-4087-8b9f-2c5752b36793 41167-0053 HUMAN OTC DRUG Benzodent Benzocaine CREAM TOPICAL 19940512 OTC MONOGRAPH NOT FINAL part356 Chattem, Inc. BENZOCAINE .2 g/g N 20181231 41167-0060_c38b567c-a593-4251-9ceb-aab22a00f602 41167-0060 HUMAN OTC DRUG Unisom SleepTabs Doxylamine Succinate TABLET ORAL 19781018 NDA NDA018066 Chattem, Inc. DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 41167-0061_46b435db-5215-4113-aa6f-8ae6fd3883a8 41167-0061 HUMAN OTC DRUG Unisom SleepGels Nighttime Sleep-Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20070101 OTC MONOGRAPH FINAL part338 Chattem, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20191231 41167-0063_f12bcfca-cfc0-484c-ab25-080e193d3fb7 41167-0063 HUMAN OTC DRUG Unisom SleepTabs Doxylamine Succinate TABLET ORAL 20160115 ANDA ANDA040167 Chattem, Inc. DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 41167-0066_a587f165-9a90-4a5d-9070-65f2d70e8a5a 41167-0066 HUMAN OTC DRUG Unisom Warming Cherry Diphenhydramine Hydrochloride LIQUID ORAL 20131202 OTC MONOGRAPH FINAL part338 Chattem, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 41167-0067_00be3dbd-b7bb-42f7-8234-3876d7effec9 41167-0067 HUMAN OTC DRUG Unisom SleepMinis Nighttime Sleep-Aid Diphenhydramine HCl CAPSULE ORAL 20150401 OTC MONOGRAPH FINAL part338 Chattem, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41167-0073_772ddb13-0980-44b7-ab81-c1b3e302bf98 41167-0073 HUMAN OTC DRUG Icy Hot Back and Large Areas Menthol PATCH TOPICAL 20030301 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 428.5 mg/1 N 20181231 41167-0075_e7864e07-80cd-4fcc-a8cb-2f539e942e85 41167-0075 HUMAN OTC DRUG Selsun Blue Accion Humetante Selenium Sulfide SHAMPOO TOPICAL 20121201 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL N 20181231 41167-0076_e7864e07-80cd-4fcc-a8cb-2f539e942e85 41167-0076 HUMAN OTC DRUG Selsun Azul Suave y Manejable Humectante Selenium Sulfide SHAMPOO TOPICAL 20121201 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL N 20181231 41167-0077_7f57883a-ae8a-42e6-b293-850e580f2b53 41167-0077 HUMAN OTC DRUG Selsun Oro Selenium Sulfide SHAMPOO TOPICAL 19520801 NDA NDA007936 Chattem, Inc. SELENIUM SULFIDE .025 g/mL N 20181231 41167-0083_772ddb13-0980-44b7-ab81-c1b3e302bf98 41167-0083 HUMAN OTC DRUG Icy Hot Back and Large Areas Menthol PATCH TOPICAL 20030301 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 428.5 mg/1 N 20181231 41167-0084_772ddb13-0980-44b7-ab81-c1b3e302bf98 41167-0084 HUMAN OTC DRUG Icy Hot Arm Neck Leg and Small Areas Menthol PATCH TOPICAL 20001101 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 205.5 mg/1 N 20181231 41167-0085_a1960664-96aa-4c4d-b0e0-7ff1d175c702 41167-0085 HUMAN OTC DRUG Icy Hot Arthritis Camphor and Menthol LOTION TOPICAL 20111117 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAMPHOR (SYNTHETIC); MENTHOL 4; 16 g/100g; g/100g N 20181231 41167-0086_65d644ce-7f1a-4b94-b06e-ddfa0322c044 41167-0086 HUMAN OTC DRUG Icy Hot Power Gel Menthol GEL TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .16 g/g N 20181231 41167-0087_bb41ab75-a2c0-4a26-a056-4de05e67e45c 41167-0087 HUMAN OTC DRUG Icy Hot Menthol and Methyl Salicylate OINTMENT TOPICAL 19910601 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL; METHYL SALICYLATE 7.6; 29 g/100g; g/100g N 20181231 41167-0088_bb41ab75-a2c0-4a26-a056-4de05e67e45c 41167-0088 HUMAN OTC DRUG Icy Hot Menthol and Methyl Salicylate CREAM TOPICAL 19910601 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 41167-0089_bb41ab75-a2c0-4a26-a056-4de05e67e45c 41167-0089 HUMAN OTC DRUG Icy Hot Menthol and Methyl Salicylate STICK TOPICAL 19910601 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 41167-0091_0b074b34-9242-4749-ab86-2b870d85a25e 41167-0091 HUMAN OTC DRUG Icy Hot Medicated No Mess Applicator Menthol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .16 g/mL N 20181231 41167-0092_43577360-19d7-4fd9-8218-c634fc14dab3 41167-0092 HUMAN OTC DRUG Icy Hot Vanishing Scent Menthol GEL TOPICAL 20070301 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .025 g/g N 20181231 41167-0093_8e133e04-6a3a-4737-a71c-9bc5c35a0dea 41167-0093 HUMAN OTC DRUG Icy Hot Naturals Menthol CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .075 g/g N 20181231 41167-0094_2a51da3b-d81c-4d30-b3d5-6f00932d3b8b 41167-0094 HUMAN OTC DRUG Icy Hot No Mess Vapor Cough Suppresant Camphor and Eucalyptus oil and Menthol GEL TOPICAL 20100610 OTC MONOGRAPH FINAL part341 Chattem, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 5.3; 1.3; 2.8 g/100g; g/100g; g/100g N 20181231 41167-0095_cb4e43da-c3f6-4525-a274-d8a1d4700ebe 41167-0095 HUMAN OTC DRUG ICYHOT Medicated Menthol SPRAY TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 160 mg/mL N 20181231 41167-0096_41ec4c4c-d4dc-4b53-a972-38d4508e2ef7 41167-0096 HUMAN OTC DRUG Icy Hot No Mess Vapor Cough Suppresant for Kids Camphor and Eucalyptus oil and Menthol GEL TOPICAL 20100610 OTC MONOGRAPH FINAL part341 Chattem, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1.2; 2.6 g/100g; g/100g; g/100g N 20181231 41167-0104_20c254de-ce72-423f-ae3c-67a9d66c9bcd 41167-0104 HUMAN OTC DRUG Gold Bond Original Strength Menthol POWDER TOPICAL 19960429 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. LEVOMENTHOL .0015 g/g N 20181231 41167-0105_29c44a78-2791-4ccc-90d3-e99fd3535cd5 41167-0105 HUMAN OTC DRUG Cortizone 10 Plus Hydrocortisone CREAM TOPICAL 20070901 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/g N 20181231 41167-0106_53033273-7c91-411c-9c50-49b0f88507cc 41167-0106 HUMAN OTC DRUG Cortizone 10 Creme Ultra Moisturizing Cortizone LOTION TOPICAL 20130218 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100g N 20181231 41167-0170_300969f9-b88b-4e93-a4ff-e964f65b2aa1 41167-0170 HUMAN OTC DRUG Gold Bond Foot Extra Strength menthol POWDER TOPICAL 19960429 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL, UNSPECIFIED FORM 1 g/100g N 20181231 41167-0172_41d2c45c-1076-4bbf-9b8f-11b5b478aef3 41167-0172 HUMAN OTC DRUG Gold Bond Medicated Foot Menthol SPRAY TOPICAL 20011201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 1 g/100g N 20181231 41167-0174_ce94c66b-92a9-4a14-bb78-4530124b591a 41167-0174 HUMAN OTC DRUG Gold Bond Pain Relieving Foot Menthol CREAM TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 16 g/100g N 20181231 41167-0176_7a47f297-5c31-4c00-99d5-9cd98fe94424 41167-0176 HUMAN OTC DRUG Gold Bond Pain Relieving Foot Roll On Menthol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .16 g/mL N 20181231 41167-0190_0e8752dc-d308-4111-97e6-157420bbcb8a 41167-0190 HUMAN OTC DRUG Gold Bond Pain and Itch Benzethonium chloride and Lidocaine SPRAY TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. BENZETHONIUM CHLORIDE; LIDOCAINE .2; 4 g/100mL; g/100mL N 20181231 41167-0230_e35989c4-d381-47f8-a44a-6aa3b78a38a2 41167-0230 HUMAN OTC DRUG Gold Bond Baby Cornstarch Plus cornstarch and kaolin and zinc oxide POWDER TOPICAL 19960429 OTC MONOGRAPH FINAL part347 Chattem, Inc. STARCH, CORN; KAOLIN; ZINC OXIDE .79; .04; .15 g/g; g/g; g/g N 20181231 41167-0242_f7ace378-6465-4dc5-bb00-09ae02038c8e 41167-0242 HUMAN OTC DRUG Balmex Diaper Rash Zinc Oxide CREAM TOPICAL 20081215 OTC MONOGRAPH FINAL part347 Chattem, Inc. ZINC OXIDE .113 g/g N 20181231 41167-0243_f7ace378-6465-4dc5-bb00-09ae02038c8e 41167-0243 HUMAN OTC DRUG Balmex Diaper Rash Stick Zinc Oxide CREAM TOPICAL 20081215 OTC MONOGRAPH FINAL part347 Chattem, Inc. ZINC OXIDE .113 g/g E 20171231 41167-0244_4c017307-ecfe-493a-9282-0be778f695a0 41167-0244 HUMAN OTC DRUG Balmex Adult Care Rash Zinc Oxide CREAM TOPICAL 20121201 OTC MONOGRAPH FINAL part347 Chattem, Inc. ZINC OXIDE .113 g/g N 20181231 41167-0331_c1b50ddb-bad9-4148-a5de-04a8e9bd12fe 41167-0331 HUMAN OTC DRUG Cortizone 10 Intensive Healing for Eczema Hydrocortisone LOTION TOPICAL 20091208 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/g N 20181231 41167-0332_fbe41414-2362-4d33-b1e6-f17717ed4947 41167-0332 HUMAN OTC DRUG Cortizone 10 Poison Ivy Relief Pads Hydrocortisone GEL TOPICAL 20130120 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100g N 20181231 41167-0333_bec3a8e3-3dfd-4bcd-ab47-5e08fce586f0 41167-0333 HUMAN OTC DRUG Cortizone 10 Hydratensive Soothing Anti Itch Hydrocortisone LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100g N 20181231 41167-0334_81dbbcce-9383-4ac2-af9e-be0f545bd8b7 41167-0334 HUMAN OTC DRUG Cortizone 10 Hydratensive Healing Anti Itch Hydrocortisone LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100g N 20181231 41167-0335_29208060-e0d8-421e-927d-aa274b97b327 41167-0335 HUMAN OTC DRUG Cortizone 10 Intensive Healing Feminine Itch Relief Hydrocortisone CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100g N 20181231 41167-0339_29c44a78-2791-4ccc-90d3-e99fd3535cd5 41167-0339 HUMAN OTC DRUG Cortizone 10 Hydrocortisone OINTMENT TOPICAL 20070901 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 10 mg/g N 20181231 41167-0341_d294d36c-1671-4d0b-9219-c0731772d847 41167-0341 HUMAN OTC DRUG Cortizone 10 for Psoriasis Hydrocortizone LOTION TOPICAL 20160115 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100g N 20181231 41167-0342_39c225aa-6675-4215-bfed-be0ce641042b 41167-0342 HUMAN OTC DRUG Cortizone 10 Anti-itch for Diabetics Skin Hydrocortisone LOTION TOPICAL 20141222 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100g N 20181231 41167-0404_20c254de-ce72-423f-ae3c-67a9d66c9bcd 41167-0404 HUMAN OTC DRUG Gold Bond Extra Strength Menthol POWDER TOPICAL 19960429 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. LEVOMENTHOL .008 g/g N 20181231 41167-0412_3cb69e05-7ed0-4dc0-aff8-e9de38bb7acc 41167-0412 HUMAN OTC DRUG Gold Bond Ultimate Psoriasis Relief Cream Salicylic Acid LOTION TOPICAL 20160801 OTC MONOGRAPH FINAL part358H Chattem, Inc. SALICYLIC ACID 3 g/100g N 20181231 41167-0470_6c263ca4-1049-44c7-99b8-4f20554ad6f9 41167-0470 HUMAN OTC DRUG Gold Bond Ultimate Hand Sanitizer Sheer Moisture Benzethonium chloride LOTION TOPICAL 20091115 OTC MONOGRAPH NOT FINAL part333 Chattem, Inc. BENZETHONIUM CHLORIDE .2 g/100g N 20181231 41167-0501_ee09af98-ef35-44f1-9291-3163a44df677 41167-0501 HUMAN OTC DRUG Gold Bond Anti Itch Menthol and Pramoxine Hydrochloride CREAM TOPICAL 19960401 OTC MONOGRAPH FINAL part347 Chattem, Inc. MENTHOL; PRAMOXINE HYDROCHLORIDE .01; .01 g/g; g/g N 20181231 41167-0505_c7ac6d63-9786-4dfb-921c-95ab50f32f7a 41167-0505 HUMAN OTC DRUG Gold Bond Medicated Pain and Itch Relief Lidocaine hydrochloride CREAM TOPICAL 20160115 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. LIDOCAINE HYDROCHLORIDE 4 g/100g N 20181231 41167-0506_8f11d5ea-ab9b-4270-8d41-742598f6f6b6 41167-0506 HUMAN OTC DRUG Gold Bond Anti Itch Menthol, Pramoxine HCl, and Dimethicone LOTION TOPICAL 20081201 OTC MONOGRAPH FINAL part347 Chattem, Inc. MENTHOL; PRAMOXINE HYDROCHLORIDE; DIMETHICONE .005; .01; .05 g/g; g/g; g/g N 20181231 41167-0510_f201035d-335b-4fab-a5e8-fc30d1e96983 41167-0510 HUMAN OTC DRUG Gold Bond Intensive Healing Anti Itch Skin Protectant Dimethicone and Pramoxine Hydrochloride CREAM TOPICAL 20090115 OTC MONOGRAPH FINAL part347 Chattem, Inc. DIMETHICONE; PRAMOXINE HYDROCHLORIDE .06; .01 g/g; g/g N 20181231 41167-0540_f906af19-d3dc-45ba-983e-65d7d23b5eda 41167-0540 HUMAN OTC DRUG Gold Bond Ultimate Diabetics Dimethicone and White Petrolatum CREAM TOPICAL 19980203 OTC MONOGRAPH FINAL part347 Chattem, Inc. DIMETHICONE; PETROLATUM .03; .3 g/g; g/g N 20181231 41167-0567_1e622287-4a31-4cab-b317-12799ee1a8db 41167-0567 HUMAN OTC DRUG Gold Bond Medicated eczema relief Colloidal oatmeal CREAM TOPICAL 20141222 OTC MONOGRAPH FINAL part347 Chattem, Inc. OATMEAL 20 mg/g N 20181231 41167-0570_dcb80088-6f1f-4406-bc99-9ba26e51ca60 41167-0570 HUMAN OTC DRUG Aspercreme Pain Relieving Trolamine Salicylate CREAM TOPICAL 19981201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. TROLAMINE SALICYLATE 10 g/100g N 20181231 41167-0574_f7cef50a-cac8-410b-9698-b3ab125d20a3 41167-0574 HUMAN OTC DRUG Aspercreme Heat Menthol GEL TOPICAL 19981201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 10 g/100mL N 20181231 41167-0575_e819ae7f-2f20-46bd-b7a4-b4f5a57a77f9 41167-0575 HUMAN OTC DRUG Aspercreme Max No Mess Roll On Menthol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .16 g/mL N 20181231 41167-0581_76cfcb5c-b8f2-4520-b73b-7e287516fc1b 41167-0581 HUMAN OTC DRUG Aspercreme with Lidocaine No-Mess Applicator Lidocaine Hydrochloride LIQUID TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. LIDOCAINE HYDROCHLORIDE 4 g/100mL N 20191231 41167-0582_ac36dd7a-1db1-49d3-8131-8b8957b134a8 41167-0582 HUMAN OTC DRUG Aspercreme with Lidocaine Pain Relieving Creme Lidocaine Hydrochloride LOTION TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. LIDOCAINE HYDROCHLORIDE 4 g/100g N 20191231 41167-0585_ed3e8c01-be89-40ad-b993-392a9ac62e52 41167-0585 HUMAN OTC DRUG Aspercreme with Lidocaine XL Lidocaine PATCH TOPICAL 20171021 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. LIDOCAINE 422 mg/1 N 20181231 41167-0600_4e837fa7-d787-464c-b5ef-88ed39fb5818 41167-0600 HUMAN OTC DRUG Arthritis Hot Menthol and Methyl Salicylate CREAM TOPICAL 19981201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 10; 15 g/100g; g/100g N 20181231 41167-0610_60aefd90-cda0-441f-9d0f-3bd3ee4e3dd4 41167-0610 HUMAN OTC DRUG Gold Bond Original Strength Dimethicone and Menthol LOTION TOPICAL 19980203 OTC MONOGRAPH FINAL part347 Chattem, Inc. DIMETHICONE; MENTHOL .05; .0015 g/g; g/g N 20181231 41167-0625_f0d04dc1-72a2-4cf1-9434-b45520283e1c 41167-0625 HUMAN OTC DRUG Gold Bond Ultimate Protection Avobenzone and Homosalate and Octisalate and Octocrylene LOTION TOPICAL 20080301 OTC MONOGRAPH NOT FINAL part352 Chattem, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 4; 2 g/100g; g/100g; g/100g; g/100g N 20181231 41167-0640_60aefd90-cda0-441f-9d0f-3bd3ee4e3dd4 41167-0640 HUMAN OTC DRUG Gold Bond Extra Strength Dimethicone and Menthol LOTION TOPICAL 19980203 OTC MONOGRAPH FINAL part347 Chattem, Inc. DIMETHICONE; MENTHOL .05; .005 g/g; g/g N 20181231 41167-0662_758acc70-4cab-46dd-bfb4-cccf84999763 41167-0662 HUMAN OTC DRUG Gold Bond Ultimate Eczema Relief Colloidal oatmeal CREAM TOPICAL 20131006 OTC MONOGRAPH FINAL part347 Chattem, Inc. OATMEAL 20 mg/g N 20181231 41167-0663_11c4413b-ec72-4cea-b9ba-2763c830a256 41167-0663 HUMAN OTC DRUG Gold Bond Ultimate Eczema Relief Hand Colloidal oatmeal CREAM TOPICAL 20150105 OTC MONOGRAPH FINAL part347 Chattem, Inc. OATMEAL .02 g/g N 20181231 41167-0673_785d26b7-7c34-41f4-b4d5-917b6dccf324 41167-0673 HUMAN OTC DRUG Gold Bond Ultimate Healing Concentrated Therapy Cream Dimethicone Petrolatum CREAM TOPICAL 20090701 OTC MONOGRAPH FINAL part347 Chattem, Inc. DIMETHICONE; PETROLATUM .03; .3 g/g; g/g N 20181231 41167-0675_48c502b6-b845-488e-94f8-e07507aa7180 41167-0675 HUMAN OTC DRUG Gold Bond Ultimate Healing Concentrated Therapy White Petrolatum OINTMENT TOPICAL 20090701 OTC MONOGRAPH FINAL part347 Chattem, Inc. PETROLATUM 450 mg/mL N 20181231 41167-0773_ea7efced-b9d3-4857-ab48-6bb47e9a4b2a 41167-0773 HUMAN OTC DRUG Gold Bond Ultimate Hand Sanitizer Moisturizer Benzethonium Chloride LOTION TOPICAL 20091115 OTC MONOGRAPH NOT FINAL part333 Chattem, Inc. BENZETHONIUM CHLORIDE .2 g/100g N 20181231 41167-0801_5f4db1da-f3e6-4524-a713-1332e629508d 41167-0801 HUMAN OTC DRUG Icy Hot Advanced Relief Camphor and Menthol CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAMPHOR (SYNTHETIC); MENTHOL .11; .16 g/g; g/g N 20181231 41167-0805_ad7b463f-93d8-41b6-b251-a9d322a45f67 41167-0805 HUMAN OTC DRUG Icy Hot Advanced Relief Menthol Topical Analgesic PATCH TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 210 mg/1 N 20181231 41167-0827_febf0295-610c-4967-9073-e540becba1bb 41167-0827 HUMAN OTC DRUG Icy Hot Medicated Micro Menthol PATCH TOPICAL 20150102 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL, UNSPECIFIED FORM 50.25 mg/1 N 20181231 41167-0830_0209cb51-b8f2-4c06-8b69-0235f496d7df 41167-0830 HUMAN OTC DRUG Icy Hot Menthol PATCH TOPICAL 20040201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 336 mg/1 N 20181231 41167-0843_772ddb13-0980-44b7-ab81-c1b3e302bf98 41167-0843 HUMAN OTC DRUG Icy Hot Back and Large Areas Menthol PATCH TOPICAL 20030301 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 428.5 mg/1 N 20181231 41167-0844_0209cb51-b8f2-4c06-8b69-0235f496d7df 41167-0844 HUMAN OTC DRUG Icy Hot Menthol PATCH TOPICAL 20040201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 336 mg/1 N 20181231 41167-0847_772ddb13-0980-44b7-ab81-c1b3e302bf98 41167-0847 HUMAN OTC DRUG Icy Hot XL Back and Large Areas Menthol PATCH TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL 750 mg/1 N 20181231 41167-0920_c433259d-b8dc-4a07-ab60-2fdfb65235c3 41167-0920 HUMAN OTC DRUG ACT Dry Mouth Anticavity Fluoride sodium fluoride PASTE, DENTIFRICE DENTAL 20150202 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 41167-0934_aa9673b7-f427-48e9-8beb-193ea0f7098e 41167-0934 HUMAN OTC DRUG ACT Anticavity Fluoride Rinse Kids Scooby Doo sodium fluoride RINSE TOPICAL 20121201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .5 mg/mL N 20181231 41167-0935_2ab2037e-36a1-46b1-9b5a-abbc514a5b5a 41167-0935 HUMAN OTC DRUG ACT Anticavity Fluoride Kids Spongebob Sodium fluoride RINSE TOPICAL 20100201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 41167-0936_4bf8725e-7267-42c8-8d2b-845842c1ff18 41167-0936 HUMAN OTC DRUG ACT Kids Anticavity Fluoride Fruit Punch sodium fluoride RINSE TOPICAL 20151216 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .5 mg/mL N 20181231 41167-0938_91960de1-1932-4575-bc51-a4ffe339b23b 41167-0938 HUMAN OTC DRUG ACT Kids Anticavity Fluoride Wild Watermelon sodium fluoride RINSE TOPICAL 20171201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .5 mg/mL N 20181231 41167-0940_3d17225d-5718-447c-8976-2ae169822f5e 41167-0940 HUMAN OTC DRUG ACT Anticavity Fluoride Cinnamon Sodium fluoride RINSE TOPICAL 19940401 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 41167-0942_3b89d181-718f-41a7-8cbc-ffbbaa2bf7fc 41167-0942 HUMAN OTC DRUG ACT Anticavity Fluoride Mint Sodium Fluoride RINSE TOPICAL 19940401 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL N 20191231 41167-0943_c7de5fc2-c314-4891-8b61-113fabb26f9b 41167-0943 HUMAN OTC DRUG Act Total Care Anticavity Fluoride Fresh Mint sodium fluoride RINSE TOPICAL 20120101 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL N 20191231 41167-0944_016468f8-c790-4329-ad55-043ed38d7004 41167-0944 HUMAN OTC DRUG ACT Anticavity Fluoride Kids Bubblegum Sodium fluoride RINSE TOPICAL 19930201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 41167-0952_b5c58aa6-badc-4b73-8d8d-57a8330f6c87 41167-0952 HUMAN OTC DRUG ACT Braces Care Anticavity sodium fluoride MOUTHWASH ORAL 20140203 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL N 20181231 41167-0954_1d22144b-520c-421c-92ca-2df94e1a42f7 41167-0954 HUMAN OTC DRUG ACT Advanced Care Plaque Guard Antigingivitis Antiplaque Frosted Mint cetylpyridinium chloride MOUTHWASH ORAL 20150202 OTC MONOGRAPH NOT FINAL part356 Chattem, Inc. CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 41167-0955_1d22144b-520c-421c-92ca-2df94e1a42f7 41167-0955 HUMAN OTC DRUG ACT Advanced Care Plaque Guard Antigingivitis Antiplaque Clean Mint cetylpyridinium chloride MOUTHWASH ORAL 20150202 OTC MONOGRAPH NOT FINAL part356 Chattem, Inc. CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 41167-0956_33dfc497-5e53-4b06-bb87-c39fbab736af 41167-0956 HUMAN OTC DRUG ACT Restoring Anticavity Fluoride Spearmint sodium fluoride MOUTHWASH TOPICAL 20060201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 41167-0957_7ff06adb-23d6-4e42-8675-59daf384df5f 41167-0957 HUMAN OTC DRUG ACT Restoring Anticavity Fluoride Cool Mint sodium fluoride MOUTHWASH TOPICAL 20060201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 41167-0961_485471fc-5cae-4b1a-9a6c-e690601ab64a 41167-0961 HUMAN OTC DRUG ACT Total Care Anticavity Fluoride Fresh Mint sodium fluoride RINSE TOPICAL 20090201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL N 20191231 41167-0962_2333c1dc-3b22-485b-a9a5-2e1c0f67fdad 41167-0962 HUMAN OTC DRUG ACT Anticavity Fluoride Mint sodium fluoride RINSE TOPICAL 20090201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL N 20181231 41167-0964_542fa480-0ac2-4554-ba2f-2144facf825a 41167-0964 HUMAN OTC DRUG ACT Total Care Sensitive Anticavity Mint Mouth Sodium Fluoride RINSE TOPICAL 20120101 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL N 20181231 41167-0965_5de31d5e-722a-41fb-be8b-ea77dbbd0a6a 41167-0965 HUMAN OTC DRUG ACT Total Care Anticavity Fluoride Icy Clean Mint sodium fluoride MOUTHWASH TOPICAL 20090201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 41167-0966_79909f69-c8c6-410f-b42a-3d326b54caa7 41167-0966 HUMAN OTC DRUG ACT Total Care Anticavity Fluoride Icy Clean Mint sodium fluoride MOUTHWASH TOPICAL 20090201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL N 20191231 41167-0968_0fccb3d0-75f4-4ed8-8fee-bea9c90a9203 41167-0968 HUMAN OTC DRUG ACT Total Care Dry Mouth Anticavity Mouth Sodium Fluoride RINSE TOPICAL 20110201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL N 20181231 41167-0969_8eec5766-4815-4b4b-b2b6-e29562b3441f 41167-0969 HUMAN OTC DRUG ACT Total Care Sensitive Anticavity Tropical Mouth Sodium Fluoride RINSE TOPICAL 20120101 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL N 20181231 41167-0977_b7a87569-3497-4f0b-9e75-38ce740ad48d 41167-0977 HUMAN OTC DRUG ACT Restoring Anticavity Fluoride Cool Splash Vanilla Mint sodium fluoride MOUTHWASH TOPICAL 20060801 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .5 mg/mL N 20181231 41167-0978_a8ae4097-867d-491b-8374-b3302ec30949 41167-0978 HUMAN OTC DRUG ACT Restoring Anticavity Fluoride Mint Burst Sodium fluoride MOUTHWASH ORAL 20151216 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 41167-0979_1c1adc43-2175-4a80-80ed-aa81d1b50efb 41167-0979 HUMAN OTC DRUG ACT Restoring Anticavity Fluoride Mint Burst Sodium fluoride MOUTHWASH ORAL 20151216 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .5 mg/mL N 20181231 41167-0980_7023c87e-b16d-4aba-97d4-8e12b7829d07 41167-0980 HUMAN OTC DRUG ACT Restoring Anticavity Fluoride Mouthwash Cool Splash Spearmint 2X sodium fluoride MOUTHWASH TOPICAL 20060201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 41167-0981_a6b1ed5d-25c2-4b7d-9530-48f1376930fc 41167-0981 HUMAN OTC DRUG ACT Restoring Anticavity Fluoride Cool Mint sodium fluoride MOUTHWASH TOPICAL 20060201 OTC MONOGRAPH FINAL part355 Chattem, Inc. SODIUM FLUORIDE .09 mg/mL N 20191231 41167-1000_63358a2d-c3c2-4cb2-9ab4-fd82aa1c3966 41167-1000 HUMAN OTC DRUG Rolaids Regular Strength Mint Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20130901 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 550; 110 mg/1; mg/1 N 20181231 41167-1001_6953a7f2-6eff-4c81-9015-b6964da0ce45 41167-1001 HUMAN OTC DRUG Rolaids Extra Strength Mint Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20130901 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 675; 135 mg/1; mg/1 N 20181231 41167-1002_99ccd098-bbdd-4084-9f28-0edce57aab72 41167-1002 HUMAN OTC DRUG Rolaids Extra Strength Fruit Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20130901 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 675; 135 mg/1; mg/1 N 20181231 41167-1003_0855d225-454b-4347-923c-81f7851ad9ca 41167-1003 HUMAN OTC DRUG Rolaids Ultra Strength Mint Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20130901 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 1000; 200 mg/1; mg/1 N 20181231 41167-1004_082c8784-c8e0-4825-b955-bc2819c25600 41167-1004 HUMAN OTC DRUG Rolaids Ultra Strength Fruit Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20130901 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 1000; 200 mg/1; mg/1 N 20181231 41167-1005_d0c28b8c-cb67-4f50-afa7-e971a488a7b2 41167-1005 HUMAN OTC DRUG Rolaids Regular Strength- Mint Calcium carbonate and Magnesium hydroxide LIQUID ORAL 20130801 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 550; 110 mg/5mL; mg/5mL N 20181231 41167-1006_d0c28b8c-cb67-4f50-afa7-e971a488a7b2 41167-1006 HUMAN OTC DRUG Rolaids Regular Strength- Cherry Calcium carbonate and Magnesium hydroxide LIQUID ORAL 20130801 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 550; 110 mg/5mL; mg/5mL N 20181231 41167-1007_d0c28b8c-cb67-4f50-afa7-e971a488a7b2 41167-1007 HUMAN OTC DRUG Rolaids Ultra Strength- Mint Calcium carbonate and Magnesium hydroxide LIQUID ORAL 20130801 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 1000; 200 mg/5mL; mg/5mL N 20181231 41167-1008_d0c28b8c-cb67-4f50-afa7-e971a488a7b2 41167-1008 HUMAN OTC DRUG Rolaids Ultra Strength- Cherry Calcium carbonate and Magnesium hydroxide LIQUID ORAL 20130801 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 1000; 200 mg/5mL; mg/5mL N 20181231 41167-1030_d485d6d2-e33d-4ceb-8f4a-51c1b47453e0 41167-1030 HUMAN OTC DRUG Rolaids Ultra Strength Antacid Orange Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20141201 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 1330; 235 mg/1; mg/1 N 20181231 41167-1031_d485d6d2-e33d-4ceb-8f4a-51c1b47453e0 41167-1031 HUMAN OTC DRUG Rolaids Ultra Strength Antacid Strawberry Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20141201 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 1330; 235 mg/1; mg/1 N 20181231 41167-1040_d2966b32-2133-45ce-a5d4-a05577688b98 41167-1040 HUMAN OTC DRUG Rolaids Advanced Antacid Anti-gas Mixed Berry Calcium carbonate and Magnesium hydroxide and Simethicone TABLET, CHEWABLE ORAL 20150202 OTC MONOGRAPH FINAL part331 Chattem, Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE; DIMETHICONE 1000; 200; 40 mg/1; mg/1; mg/1 N 20181231 41167-1214_549fdf39-cc3c-427d-b63c-dda4a6307b76 41167-1214 HUMAN OTC DRUG Capzasin P Arthritis Pain Relief Capsaicin CREAM TOPICAL 19981201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAPSAICIN .00035 g/g N 20181231 41167-1601_5aaee419-03c3-4a60-b3d5-26797873d141 41167-1601 HUMAN OTC DRUG Flexall Pain Relieving Menthol GEL TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .07 g/g N 20181231 41167-1602_f26fd3eb-77ed-4ed6-bb0d-9966272f084b 41167-1602 HUMAN OTC DRUG Flexall Pain Relieving Menthol GEL TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL .16 g/g N 20181231 41167-1603_8651e406-ab35-4125-a263-466b3c8fb0e1 41167-1603 HUMAN OTC DRUG Flexall Plus Menthol and Camphor and Methyl Salicylate GEL TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. MENTHOL; CAMPHOR (SYNTHETIC); METHYL SALICYLATE .16; .031; .1 g/g; g/g; g/g N 20181231 41167-1651_ba27bbfd-8a35-4df6-b7da-e6fe6da0b82c 41167-1651 HUMAN OTC DRUG Selsun Blue 2-in-1 Selenium Sulfide SHAMPOO TOPICAL 20020401 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL N 20181231 41167-1710_f0b36ffd-c217-47e0-b2a8-f5c143ec0f0f 41167-1710 HUMAN OTC DRUG Icy Hot with Lidocaine Pain Relieving Lidocaine HCl and Menthol CREAM TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. LIDOCAINE; MENTHOL .4; .1 g/g; g/g N 20181231 41167-3001_9caea95b-d2df-44d0-a6e9-4e8f21f56c78 41167-3001 HUMAN OTC DRUG Pamprin Multisymptom Menstrual Pain Relief Acetaminophen and Pamabrom and Pyrilamine Maleate TABLET ORAL 20100501 OTC MONOGRAPH NOT FINAL part343 Chattem, Inc. ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 41167-3002_090ab462-57db-4087-8fa8-712ecfa5af50 41167-3002 HUMAN OTC DRUG Pamprin Cramp Menstrual Pain Relief Acetaminophen and Magnesium Salicylate and Pamabrom TABLET ORAL 19830101 OTC MONOGRAPH NOT FINAL part343 Chattem, Inc. ACETAMINOPHEN; MAGNESIUM SALICYLATE; PAMABROM 250; 250; 25 mg/1; mg/1; mg/1 N 20181231 41167-3006_14eab422-6e81-4f2e-9272-81f8f170c154 41167-3006 HUMAN OTC DRUG Pamprin Max Menstrual Pain Relief Acetaminophen and Aspirin and Caffeine TABLET ORAL 20060201 OTC MONOGRAPH NOT FINAL part343 Chattem, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 41167-3102_6d719c5a-4100-4109-b630-35d2b04d03ff 41167-3102 HUMAN OTC DRUG Premsyn pms Premenstrual Syndrome Relief Acetaminophen and Pamabrom and Pyrilamine maleate TABLET ORAL 20100501 OTC MONOGRAPH NOT FINAL part343 Chattem, Inc. ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 41167-3305_db8b7692-b96c-45de-82cd-68747af05797 41167-3305 HUMAN OTC DRUG BullFrog Quik Avobenzone and Homosalate and Octisalate and Octocrylene and Oxybenzone GEL TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 Chattem, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .05; .1; .06 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 41167-3318_db8b7692-b96c-45de-82cd-68747af05797 41167-3318 HUMAN OTC DRUG BullFrog Quik Gel Sport Avobenzone and Homosalate and Octisalate and Octocrylene and Oxybenzone SPRAY TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 Chattem, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .15; .05; .1; .06 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 41167-3330_bce6edb4-156e-46ae-8a93-ebee267f355c 41167-3330 HUMAN OTC DRUG Kaopectate Regular Strength Peppermint Flavor Anti Diarrheal bismuth subsalicylate LIQUID ORAL 20030401 OTC MONOGRAPH FINAL part335 Chattem, Inc. BISMUTH SUBSALICYLATE 17.47 mg/mL N 20181231 41167-3510_4c4f773e-403a-4dd0-8b81-ea7a97e7b275 41167-3510 HUMAN OTC DRUG Xyzal Allergy 24HR Levocetirizine dihydrochloride TABLET ORAL 20170310 NDA NDA209089 Chattem, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 N 20181231 41167-3530_29522ef9-54df-4d80-9c76-72ab8d687168 41167-3530 HUMAN OTC DRUG Childrens Xyzal Allergy Levocetirizine dihydrochloride SOLUTION ORAL 20170216 NDA NDA209090 Chattem, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL N 20181231 41167-4000_c62ce0c1-235d-41f6-8602-60ab30e8843f 41167-4000 HUMAN OTC DRUG Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal bismuth subsalicylate LIQUID ORAL 20030401 OTC MONOGRAPH FINAL part335 Chattem, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 41167-4002_8ee4dc5e-df8e-4c0d-8522-a648565ea366 41167-4002 HUMAN OTC DRUG Kaopectate Bismuth subsalicylate TABLET ORAL 20130401 OTC MONOGRAPH FINAL part335 Chattem, Inc. BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 41167-4120_25f66a89-8281-4157-9316-2b3f8abbe2a2 41167-4120 HUMAN OTC DRUG Allegra Allergy fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110303 NDA NDA020872 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20191231 41167-4121_25f66a89-8281-4157-9316-2b3f8abbe2a2 41167-4121 HUMAN OTC DRUG Allegra Allergy fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110303 NDA NDA020872 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20191231 41167-4122_f214e530-2dc9-43c8-8563-b10b7b478690 41167-4122 HUMAN OTC DRUG Allegra Allergy Fexofenadine Hydrochloride TABLET, COATED ORAL 20141217 NDA NDA020872 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 41167-4131_25f66a89-8281-4157-9316-2b3f8abbe2a2 41167-4131 HUMAN OTC DRUG Allegra Allergy fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110303 NDA NDA020872 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20191231 41167-4232_6de7bd31-13fe-408d-970a-c3f5dfaaa3f7 41167-4232 HUMAN OTC DRUG Childrens Allegra Allergy Fexofenadine Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20140102 NDA NDA021909 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 30 mg/1 N 20181231 41167-4233_aa079b70-d080-4841-af87-6706906596cd 41167-4233 HUMAN OTC DRUG Childrens Allegra Allergy Fexofenadine Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110303 NDA NDA021909 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 30 mg/1 N 20181231 41167-4244_0259c9ca-8b2d-462d-8de7-eac5085ac332 41167-4244 HUMAN OTC DRUG Childrens Allegra Allergy Fexofenadine Hydrochloride SUSPENSION ORAL 20110303 NDA NDA201373 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE 6 mg/mL N 20181231 41167-4255_0e4de333-b970-4623-b91d-3aaa67cdcbe7 41167-4255 HUMAN OTC DRUG Allegra Cooling Relief Anti-Itch Diphenhydramine HCl, Allantoin CREAM TOPICAL 20121201 OTC MONOGRAPH FINAL part347 Chattem, Inc. ALLANTOIN; DIPHENHYDRAMINE HYDROCHLORIDE .5; 2 g/100g; g/100g N 20181231 41167-4266_0e4de333-b970-4623-b91d-3aaa67cdcbe7 41167-4266 HUMAN OTC DRUG Allegra Intensive Relief Anti-Itch Diphenhydramine HCl, Allantoin CREAM TOPICAL 20121201 OTC MONOGRAPH FINAL part347 Chattem, Inc. ALLANTOIN; DIPHENHYDRAMINE HYDROCHLORIDE .5; 2 g/100g; g/100g N 20181231 41167-4310_b4bcc9ab-9629-4a67-a677-e6c9791b4a95 41167-4310 HUMAN OTC DRUG Allegra-D Allergy and Congestion fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110303 NDA NDA020786 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 N 20191231 41167-4320_d8a87caf-5fce-4fed-aa62-b1b70ae010c7 41167-4320 HUMAN OTC DRUG Allegra-D Allergy and Congestion fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110303 NDA NDA021704 Chattem, Inc. FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 N 20191231 41167-5800_0a2a9674-0cb5-40f5-a62b-a8b4823a4dee 41167-5800 HUMAN OTC DRUG Nasacort Allergy 24HR Triamcinolone Acetonide SPRAY, METERED NASAL 20140203 NDA NDA020468 Chattem, Inc. TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 41167-5900_c308ad0e-ab60-485f-b1db-f659fe445a73 41167-5900 HUMAN OTC DRUG Childrens Nasacort Allergy 24HR Triamcinolone Acetonide SPRAY, METERED NASAL 20150701 NDA NDA020468 Chattem, Inc. TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 41167-6011_6419cdb5-a4b9-4714-9fb0-9c32fa84e6e7 41167-6011 HUMAN OTC DRUG Selsun Blue Deep Cleansing Micro-Bead Scrub Salicylic Acid SHAMPOO TOPICAL 20101101 OTC MONOGRAPH FINAL part358H Chattem, Inc. SALICYLIC ACID .03 g/mL N 20181231 41167-6020_e457808d-7ca0-4448-8852-7ded0387171e 41167-6020 HUMAN OTC DRUG Selsun Blue Itchy Dry Scalp PYRITHIONE ZINC SHAMPOO TOPICAL 20091201 OTC MONOGRAPH FINAL part358H Chattem, Inc. PYRITHIONE ZINC .01 g/mL N 20181231 41167-6021_2e3e3848-2c22-41aa-94d7-6b687df36e41 41167-6021 HUMAN OTC DRUG Selsun Blue Sensitive Scalp Zinc Pyrithione SHAMPOO TOPICAL 20131201 OTC MONOGRAPH FINAL part358H Chattem, Inc. PYRITHIONE ZINC .01 g/mL N 20181231 41167-6032_ba27bbfd-8a35-4df6-b7da-e6fe6da0b82c 41167-6032 HUMAN OTC DRUG Selsun Blue Moisturizing Selenium Sulfide SHAMPOO TOPICAL 20020401 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL N 20181231 41167-6040_b75928bc-1883-4641-9b82-cb8fc79fb2c9 41167-6040 HUMAN OTC DRUG Selsun Blue Scalp Itch Treatment Hydrocortisone LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. HYDROCORTISONE 1 g/100mL N 20181231 41167-6050_57ff5f15-ae41-434d-8ae0-ce5e416db41a 41167-6050 HUMAN OTC DRUG Kaopectate Regular Strength Cherry Flavor Bismuth subsalicylate LIQUID ORAL 20040430 OTC MONOGRAPH FINAL part335 Chattem, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 41167-6061_ba27bbfd-8a35-4df6-b7da-e6fe6da0b82c 41167-6061 HUMAN OTC DRUG Selsun Blue Medicated Selenium Sulfide SHAMPOO TOPICAL 20020401 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL N 20181231 41167-6100_3cdfd829-100a-4aa1-aa94-f0782757efbd 41167-6100 HUMAN OTC DRUG Surfak Stool Softener Docusate calcium CAPSULE, GELATIN COATED ORAL 20090101 OTC MONOGRAPH NOT FINAL part334 Chattem, Inc. DOCUSATE CALCIUM 240 mg/1 N 20191231 41167-6132_b23fad21-731b-4432-8b29-f2ebd1076de7 41167-6132 HUMAN OTC DRUG Selsun Blue Full and Thick Pyrithione Zinc SHAMPOO TOPICAL 20151101 OTC MONOGRAPH FINAL part358H Chattem, Inc. PYRITHIONE ZINC .01 g/mL N 20181231 41167-6152_5dd9a848-14eb-4ff5-a311-3d11fcb97fd2 41167-6152 HUMAN OTC DRUG Selsun Blue Active 3-in-1 Salicylic acid SHAMPOO TOPICAL 20171109 OTC MONOGRAPH FINAL part358H Chattem, Inc. SALICYLIC ACID .02 g/mL N 20191231 41167-6174_9151abaf-9390-4853-b02a-cfdd337cfb0a 41167-6174 HUMAN OTC DRUG Selsun Blue Naturals Island Breeze Salicylic Acid SHAMPOO TOPICAL 20101101 OTC MONOGRAPH FINAL part358H Chattem, Inc. SALICYLIC ACID .03 g/mL N 20181231 41167-6180_9f4fbdff-5e44-481d-b208-be20367901b8 41167-6180 HUMAN OTC DRUG Selsun Blue Naturals Itchy, Dry Scalp Salicylic Acid SHAMPOO TOPICAL 20101101 OTC MONOGRAPH FINAL part358H Chattem, Inc. SALICYLIC ACID .03 g/mL N 20181231 41167-6202_ba27bbfd-8a35-4df6-b7da-e6fe6da0b82c 41167-6202 HUMAN OTC DRUG Selsun Blue Normal to Oily Selenium Sulfide SHAMPOO TOPICAL 20020401 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL N 20181231 41167-7300_be40e4cb-40e8-4ade-a35d-a32e6fa3347a 41167-7300 HUMAN OTC DRUG Sportscreme Trolamine Salicylate CREAM TOPICAL 19990101 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. TROLAMINE SALICYLATE 10 g/100g N 20181231 41167-7449_bce6edb4-156e-46ae-8a93-ebee267f355c 41167-7449 HUMAN OTC DRUG Kaopectate Extra Strength Peppermint Flavor Anti Diarrheal bismuth subsalicylate LIQUID ORAL 20030401 OTC MONOGRAPH FINAL part335 Chattem, Inc. BISMUTH SUBSALICYLATE 35 mg/mL N 20181231 41167-7514_2823d2d4-d0a4-4c71-b06b-11b1812f6e76 41167-7514 HUMAN OTC DRUG Capzasin HP Arthritis Pain Relief Capsaicin CREAM TOPICAL 19981201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAPSAICIN .001 g/g N 20181231 41167-7516_52205963-7ae6-402b-aeb7-823c53b0c660 41167-7516 HUMAN OTC DRUG Capzasin Quick Relief Capsaicin and Menthol GEL TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAPSAICIN; MENTHOL .00025; .1 g/g; g/g N 20181231 41167-7518_3c37e161-26f8-4d7b-a527-62fcfbb7d3f0 41167-7518 HUMAN OTC DRUG Capzasin No Mess Applicator Capsaicin LIQUID TOPICAL 20061201 OTC MONOGRAPH NOT FINAL part348 Chattem, Inc. CAPSAICIN .0015 g/mL N 20181231 41167-7773_3e511a7f-edfa-408c-a646-430dc0bf7981 41167-7773 HUMAN OTC DRUG Herpecin Dimethicone and Meradimate and Octinoxate and Octisalate and Oxybenzone STICK TOPICAL 19960429 OTC MONOGRAPH NOT FINAL part352 Chattem, Inc. DIMETHICONE; MERADIMATE; OCTINOXATE; OCTISALATE; OXYBENZONE 1; 5; 7.5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20191231 41167-9005_e7864e07-80cd-4fcc-a8cb-2f539e942e85 41167-9005 HUMAN OTC DRUG Selsun Azul Revitalizante Selenium Sulfide SHAMPOO TOPICAL 20121201 OTC MONOGRAPH FINAL part358H Chattem, Inc. SELENIUM SULFIDE 1 g/100mL N 20181231 41190-001_e7a99f41-a707-48e2-a63f-74463b7a48f1 41190-001 HUMAN OTC DRUG ShopRite Non Aspirin Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20160119 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41190-002_a0871c05-0e58-4b00-a214-9fff38cbe72b 41190-002 HUMAN OTC DRUG ShopRite antifungal Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C WAKEFERN FOOD CORPORATION CLOTRIMAZOLE 10 mg/g N 20181231 41190-003_f9dca354-1a72-4d40-b2c5-5727eabba5a9 41190-003 HUMAN OTC DRUG ShopRite Dual Action Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160205 ANDA ANDA077355 Wakefern Food Corporation FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 41190-004_c90d1fa3-effb-42ef-af17-fd5fcbacdff4 41190-004 HUMAN OTC DRUG ShopRite Allergy Relief Nasal Fluticasone propionate SPRAY, METERED NASAL 20160707 ANDA ANDA207957 Wakefern Food Corporation FLUTICASONE PROPIONATE 50 ug/1 N 20181231 41190-041_91cd60b1-cebe-405e-8ed5-5056df0461c2 41190-041 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20101214 OTC MONOGRAPH FINAL part333D Wakefern Food Corp SALICYLIC ACID 19.8 mg/g N 20181231 41190-050_dd466632-cc36-412c-aae1-4c29b77dba72 41190-050 HUMAN OTC DRUG shoprite ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20130611 ANDA ANDA079113 Wakefern Food Corporation DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 41190-054_7ff7ba8d-b9e7-4902-93ac-32a1b21e33df 41190-054 HUMAN OTC DRUG ShopRite Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140325 ANDA ANDA075153 Wakefern Food Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 41190-056_013fc702-7076-4138-8048-439aefda10b2 41190-056 HUMAN OTC DRUG ShopRite Ni Calm Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140512 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 41190-063_8be329f8-6d91-414c-b103-5237cf7449d9 41190-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Wakefern Food Corp FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 41190-065_d4ebc4bf-b367-4ba7-a9b7-21cdbd080254 41190-065 HUMAN OTC DRUG ShopRite Nasal Oxymetazoline HCl SPRAY NASAL 20130709 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41190-069_b3d7a177-7e1a-47aa-8e6d-18a93a29d355 41190-069 HUMAN OTC DRUG Petrolatum White Petrolatum JELLY TOPICAL 20090116 OTC MONOGRAPH FINAL part347 Wakefern Food Corporation PETROLATUM 1 g/g N 20181231 41190-072_8f84bb50-66b6-4128-a7a0-aa0295d783dc 41190-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol. Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19990528 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41190-074_0b896042-5a4b-40f2-8771-a4e8f6ffb320 41190-074 HUMAN OTC DRUG ShopRite Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20130806 ANDA ANDA077349 Wakefern Food Corporation IBUPROFEN 200 mg/1 N 20181231 41190-083_3e13781f-6ee4-4879-9ff6-e4a2aff25898 41190-083 HUMAN OTC DRUG ShopRite Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 WAKEFERN FOOD CORPORATION TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 41190-094_76bedbab-3288-4f28-9380-a4318647a507 41190-094 HUMAN OTC DRUG ShopRite Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20130709 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 41190-104_a0586e5a-806f-472c-859b-f2644d499060 41190-104 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE RINSE ORAL 20071019 OTC MONOGRAPH FINAL part355 Wakefern Food Corp SODIUM FLUORIDE .2 mg/mL N 20191231 41190-105_aa0020bb-eddf-496d-9628-bf3183ae2283 41190-105 HUMAN OTC DRUG ShopRite Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20130620 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 41190-112_3fab182d-ff94-4826-9d35-b2760f776dd2 41190-112 HUMAN OTC DRUG ShopRite DayTime Flu Plus Severe Cold And Cough Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 WAKEFERN FOOD CORPORATION ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 41190-113_f11d78c0-2007-4c20-a664-7ebfca15d6e2 41190-113 HUMAN OTC DRUG ShopRite Nighttime Flu Plus Severe Cold and Cough Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 WAKEFERN FOOD CORPORATION ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 41190-117_1d1e274f-b501-4ec3-a923-2b8d5cb7876b 41190-117 HUMAN OTC DRUG ShopRite Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130611 ANDA ANDA202319 Wakefern Food Corporation LANSOPRAZOLE 15 mg/1 N 20181231 41190-121_78ebe30a-d587-4846-97be-7c708eac4e79 41190-121 HUMAN OTC DRUG shoprite triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20141030 OTC MONOGRAPH FINAL part333B Wakefern Food Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 41190-124_7107833d-29c9-4641-8b12-7a4a43266167 41190-124 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20090804 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corp EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41190-130_1192fda5-3873-4d9d-aa8e-3ccf04e41fcd 41190-130 HUMAN OTC DRUG shoprite acetaminophen Acetaminophen SUSPENSION ORAL 20131212 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 41190-131_91f00602-6203-492d-a6bc-0d862923bd44 41190-131 HUMAN OTC DRUG Salicylic Acid One Step Corn Remover PATCH TOPICAL 20171227 OTC MONOGRAPH FINAL part358F Wakefern Food Corporation SALICYLIC ACID 40 mg/61 N 20181231 41190-132_50974bb8-354f-4ff9-8895-07c297839b76 41190-132 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20171227 OTC MONOGRAPH FINAL part333C Wakefern Food Corporation TOLNAFTATE 1.3 g/130g N 20181231 41190-133_991d5766-547f-4248-ac01-1b0b15d93b75 41190-133 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20171227 OTC MONOGRAPH FINAL part333C Wakefern Food Corporation TOLNAFTATE 1.5 g/150g N 20181231 41190-134_a477ff46-2682-4f0b-be99-d8f4c370ce7a 41190-134 HUMAN OTC DRUG Tolnaftate Foot Odor Control Spray AEROSOL, SPRAY TOPICAL 20171227 OTC MONOGRAPH FINAL part333C Wakefern Food Corporation TOLNAFTATE 1.13 g/113g N 20181231 41190-135_a5146b0b-10d8-4f1c-94b6-6655be6f9090 41190-135 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20171227 OTC MONOGRAPH FINAL part358F Wakefern Food Corporation SALICYLIC ACID 40 mg/91 N 20181231 41190-136_90f218ac-8ced-4de5-89e1-df1785ce2142 41190-136 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20171227 OTC MONOGRAPH FINAL part358B Wakefern Food Corporation SALICYLIC ACID .17 mg/9.8mL N 20181231 41190-141_141c935c-c630-4fe9-89ff-667339a3c046 41190-141 HUMAN OTC DRUG ShopRite Acid Reducer Famotidine TABLET ORAL 20130802 ANDA ANDA075400 Wakefern Food Corporation FAMOTIDINE 10 mg/1 N 20181231 41190-153_40e4dcae-bbd8-4395-8841-cf0aa8c33335 41190-153 HUMAN OTC DRUG Everday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19981205 OTC MONOGRAPH FINAL part358H Wakern Food Corp. PYRITHIONE ZINC 10 mg/mL N 20181231 41190-161_4fecf96e-b764-4b7a-8fb3-30a7d7da5f5b 41190-161 HUMAN OTC DRUG ShopRite Infants Acetaminophen Acetaminophen SUSPENSION ORAL 20130620 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 41190-163_71639837-6b08-4df7-bb4a-dbcdfbe4bbdf 41190-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20100305 OTC MONOGRAPH FINAL part355 Wakefern Food Corp SODIUM FLUORIDE 1 mg/mL N 20181231 41190-166_7e58c48a-e114-40f4-ba06-398099264203 41190-166 HUMAN OTC DRUG ShopRite Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20130819 ANDA ANDA074937 Wakefern Food Corporation IBUPROFEN 100 mg/5mL N 20181231 41190-175_5d6d5b19-8287-4311-8fe4-66ef66e06c52 41190-175 HUMAN OTC DRUG ShopRite Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20130814 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 41190-176_52eb0dd9-833a-4656-abd2-7413b605f134 41190-176 HUMAN OTC DRUG ShopRite Allergy D 12 Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20130917 ANDA ANDA077170 Wakefern Food Corporation CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 41190-179_8f6b66f6-a486-4cae-9bb1-f4423ac68a18 41190-179 HUMAN OTC DRUG ShopRite Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20170130 OTC MONOGRAPH FINAL part331 Wakefern Food Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 41190-186_5904b92f-d0a0-4e2c-9917-025ecf2e1b7a 41190-186 HUMAN OTC DRUG ShopRite Sleep Aid Diphenhydramine HCl SOLUTION ORAL 20130717 OTC MONOGRAPH FINAL part338 Wakefern Food Corporation DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 41190-194_fadbab19-6722-4ee8-8e07-f6c6a0524575 41190-194 HUMAN OTC DRUG ShopRite Acid Reducer Famotidine TABLET ORAL 20130620 ANDA ANDA077351 Wakefern Food Corporation FAMOTIDINE 20 mg/1 N 20181231 41190-200_19929a0d-9ea9-45d4-8616-adac10434777 41190-200 HUMAN OTC DRUG ShopRite Original Fiber PSYLLIUM HUSK POWDER, FOR SOLUTION ORAL 20150604 OTC MONOGRAPH NOT FINAL part334 WakeFern Food Corp. PSYLLIUM HUSK .486 g/g N 20181231 41190-201_c05ff0c2-8542-48d2-a09c-503863f88418 41190-201 HUMAN OTC DRUG ShopRite Sugar Free Fiber, Orange Flavor PSYLLIUM HUSK POWDER, FOR SOLUTION ORAL 20150604 OTC MONOGRAPH NOT FINAL part334 WakeFern Food Corp. PSYLLIUM HUSK .604 g/g N 20181231 41190-203_60cc66e2-4238-4103-9e2c-8a1b4c12334b 41190-203 HUMAN OTC DRUG Hand Sanitizer with Aloe Alcohol GEL TOPICAL 20110614 OTC MONOGRAPH NOT FINAL part333A Shop Rite ALCOHOL .65 mL/100L N 20181231 41190-205_6244722d-700e-43cc-9764-b46fab05a23e 41190-205 HUMAN OTC DRUG Therapeutic Plus Coal Tar SHAMPOO TOPICAL 20020415 OTC MONOGRAPH FINAL part358H Wakefern Food Corp. COAL TAR 25 mg/mL N 20181231 41190-207_ba1b54b8-f747-46dd-95cd-435450d7b43f 41190-207 HUMAN OTC DRUG Wakefern Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20130603 OTC MONOGRAPH NOT FINAL part356 Wakefern SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 41190-208_747acdfe-efa9-42a4-91fb-bdb34fa5d323 41190-208 HUMAN OTC DRUG Wakefern Enamel Guard Fluoride PASTE, DENTIFRICE DENTAL 20140203 OTC MONOGRAPH NOT FINAL part356 Wakefern SODIUM FLUORIDE; POTASSIUM NITRITE .15; 5 g/100g; g/100g N 20181231 41190-210_817df8af-f419-49fd-9370-3bcc649e72f7 41190-210 HUMAN OTC DRUG Advanced Antiseptic Eucalyptol MOUTHWASH ORAL 20101124 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .042; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L N 20181231 41190-213_ca9bf5e8-9e1d-46b4-a213-79d6c8168151 41190-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20020711 OTC MONOGRAPH FINAL part355 Wakefern Food Corp SODIUM FLUORIDE .05 kg/100L N 20181231 41190-224_df259d4a-9f49-457b-a0ab-ed30506f3a2f 41190-224 HUMAN OTC DRUG ShopRite Anti Diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20130917 ANDA ANDA075232 Wakefern Food Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 41190-227_b7189b9c-d148-452b-bfd8-8b55ecbb66ef 41190-227 HUMAN OTC DRUG ShopRite non aspirin Acetaminophen TABLET, FILM COATED ORAL 20161117 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 500 mg/1 N 20181231 41190-243_6715d629-6034-4020-a328-bf54d1a2c970 41190-243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20090106 OTC MONOGRAPH FINAL part333A Wakefern Food Corporation TRICLOSAN .15 kg/100L N 20181231 41190-244_be04cf5b-a4ad-4d5d-b926-beeacf1bb7eb 41190-244 HUMAN OTC DRUG ShopRite Antibacterial Moist WipesAntibacterial Moi Antibacterial Moist Wipes Benzalkonium Chloride CLOTH TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 41190-245_25c8511c-e098-24df-e054-00144ff88e88 41190-245 HUMAN OTC DRUG ShopRite Antibacterial Moist Wipes Benzalkonium Chloride wipes SWAB TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 41190-255_2a3d4633-4372-4efd-887a-719f22e7ae48 41190-255 HUMAN OTC DRUG ShopRite Infants Ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20130617 ANDA ANDA075217 Wakefern Food Corporation IBUPROFEN 50 mg/1.25mL N 20181231 41190-272_c0618d9a-6e61-404c-a8cc-4e0e5cf2c310 41190-272 HUMAN OTC DRUG shoprite sinus congestion and pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20170915 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 41190-278_cb909379-5e8b-41ba-b799-0c9429a2c650 41190-278 HUMAN OTC DRUG Benzalkonium chloride Benzalkonium chloride 0.13% SOAP TOPICAL 20170710 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 41190-279_3af79e86-e98b-4024-8d67-c970c65f5deb 41190-279 HUMAN OTC DRUG shoprite hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141112 OTC MONOGRAPH FINAL part346 Wakefern Food Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 41190-281_34b3e529-60fc-430d-9e2d-baa02a91533b 41190-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 19920511 OTC MONOGRAPH FINAL part358H Wakfern Food Corporation PYRITHIONE ZINC 1 kg/100L N 20181231 41190-295_cea6026a-c281-4be9-a640-85d8ce3b73c3 41190-295 HUMAN OTC DRUG Diphenhydramine HCl, Zinc Acetate Diphenhydramine HCl, Zinc Acetate SPRAY TOPICAL 20100806 OTC MONOGRAPH NOT FINAL part348 Wakefern Food Corp DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 18; 882 mg/mL; mg/mL N 20181231 41190-296_a8d43451-92cc-4097-95e3-2782c07a68a8 41190-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20090501 OTC MONOGRAPH FINAL part358H Wakefern Food Corp PYRITHIONE ZINC 10 mg/mL N 20181231 41190-299_1b388867-78d6-48bf-afbe-30fc5b245139 41190-299 HUMAN OTC DRUG Antiseptic cetylpyridinium chloride MOUTHWASH ORAL 20110708 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corp CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 41190-302_cf109680-21ed-4294-b800-fc9a6bc4619f 41190-302 HUMAN OTC DRUG ShopRite Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20130806 OTC MONOGRAPH FINAL part335 Wakefern Food Corporation BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 41190-306_9ccb9637-36e5-4a07-8b95-b633184cb34d 41190-306 HUMAN OTC DRUG ShopRite Clear Laxative Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20130806 ANDA ANDA090685 Wakefern Food Corporation POLYETHYLENE GLYCOL 3350 17 g/17g N 20191231 41190-310_b070c642-406c-40a5-832f-822263ee150a 41190-310 HUMAN OTC DRUG ShopRite Adult Tussin Guaifenesin SOLUTION ORAL 20140512 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation GUAIFENESIN 200 mg/10mL N 20181231 41190-311_c6eb3417-34c3-49e2-800a-af6190951a89 41190-311 HUMAN OTC DRUG Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20090409 OTC MONOGRAPH FINAL part358H Wakefern PYRITHIONE ZINC 10 mg/mL N 20181231 41190-318_29a40f0b-fab3-416e-933d-ff48a3032063 41190-318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 19900813 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 41190-319_a8ba2234-2037-4bb9-ac9a-b5951f49fb32 41190-319 HUMAN OTC DRUG ShopRite Hydrocortisone Hydrocortisone CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part348 Wakefern Food Corporation HYDROCORTISONE 1 g/100g N 20181231 41190-332_bdff7c60-8e54-4dba-9e08-506960f4beb5 41190-332 HUMAN OTC DRUG shoprite milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20150429 OTC MONOGRAPH NOT FINAL part334 Wakefern Food Corporation MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 41190-335_ea8cdf74-0f76-4941-a1b3-26313729f2bf 41190-335 HUMAN OTC DRUG ShopRite Ni Calm Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20130617 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 41190-337_ef3fd1ef-20aa-48d3-a098-10ce5077de1e 41190-337 HUMAN OTC DRUG ShopRite Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20130814 OTC MONOGRAPH FINAL part335 Wakefern Food Corporation BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 41190-357_9e766a50-5502-4962-9dcc-ff7d3a2166d2 41190-357 HUMAN OTC DRUG shoprite antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20130828 OTC MONOGRAPH FINAL part331 Wakefern Food Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 41190-358_f6277112-ca0c-4301-b7ad-e61776d834f6 41190-358 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20150107 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 41190-359_84f65078-906b-4222-8f91-eba6aec95667 41190-359 HUMAN OTC DRUG shoprite adult tussin Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20140501 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 41190-368_6b6d4b59-b38c-459c-ad86-ae6cfeb6868e 41190-368 HUMAN OTC DRUG ShopRite Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20130814 ANDA ANDA074661 Wakefern Food Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 41190-370_00fc2c51-fe99-4982-a944-9c31bbb53221 41190-370 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20150127 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp. ALCOHOL 70 mL/100mL N 20181231 41190-374_ccd931ad-b2be-499c-b44a-be428c986e25 41190-374 HUMAN OTC DRUG ShopRite Migraine Formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20130620 ANDA ANDA075794 Wakefern Food Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 41190-379_682c5cd9-df27-4b45-8de8-27f454b745ab 41190-379 HUMAN OTC DRUG ShopRite Childrens Allergy Diphenhydramine HCl SOLUTION ORAL 20160111 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 41190-396_8d55927d-d43d-46d3-9eb3-818e2266be35 41190-396 HUMAN OTC DRUG shoprite milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20150429 OTC MONOGRAPH NOT FINAL part334 Wakefern Food Corporation MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 41190-403_dac0901d-eb64-4cbe-9892-c260953d7dc6 41190-403 HUMAN OTC DRUG Hand wash Benzalkonium chloride SOAP TOPICAL 20150123 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 41190-416_9f228557-7f46-4981-b462-f15864376300 41190-416 HUMAN OTC DRUG ShopRite Aspirin Aspirin TABLET ORAL 20161129 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ASPIRIN 325 mg/1 N 20181231 41190-426_a7864511-ad94-41b6-97f8-f7734eface02 41190-426 HUMAN OTC DRUG ShopRite Tioconazole 1 Tioconazole OINTMENT VAGINAL 20130917 ANDA ANDA075915 Wakefern Food Corporation TIOCONAZOLE 6.5 g/100g N 20181231 41190-428_6bb78125-5d85-42d1-8fe5-0065079e01ad 41190-428 HUMAN OTC DRUG ShopRite Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20130620 OTC MONOGRAPH FINAL part332 Wakefern Food Corporation DIMETHICONE 125 mg/1 N 20181231 41190-432_f52ddc5a-2e02-4f77-9469-5e50a461ffb0 41190-432 HUMAN OTC DRUG ShopRite Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130917 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 41190-434_81d7d7f0-17e8-4499-8229-1da7b6ee8e4f 41190-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20131005 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corp EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41190-439_0dc6b782-2546-48c8-8921-7eb0822191ba 41190-439 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20150203 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp ALCOHOL 616 mL/mL N 20181231 41190-441_92dd12a0-e3be-4ebd-9d9c-678727df73ac 41190-441 HUMAN OTC DRUG ShopRite Sleep-Aid Doxylamine succinate TABLET ORAL 20170516 ANDA ANDA040167 Wakefern Food Corporation DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 41190-443_ff4c6601-306d-488d-a325-e38ddb4542dd 41190-443 HUMAN OTC DRUG shoprite nasal allergy Triamcinolone acetonide SPRAY, METERED NASAL 20170717 ANDA ANDA078104 Wakefern Food Corporation TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 41190-458_cc0316a8-1214-4727-aa62-22279bb823c9 41190-458 HUMAN OTC DRUG ShopRite Allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20130814 ANDA ANDA078336 Wakefern Food Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 41190-459_3735c390-c07f-4024-8d3a-def6b0d988e1 41190-459 HUMAN OTC DRUG ShopRite Ni Calm Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20130617 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 41190-460_e6508707-e79c-4121-8133-a890c1a7bc4f 41190-460 HUMAN OTC DRUG shoprite congestion and pain Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20171030 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 41190-461_9aac3058-931d-4559-bf62-4363c91ee707 41190-461 HUMAN OTC DRUG ShopRite Ibuprofen IB Ibuprofen TABLET, CHEWABLE ORAL 20130702 ANDA ANDA076359 Wakefern Food Corporation IBUPROFEN 100 mg/1 N 20181231 41190-462_4c004bd0-f2b7-48bb-9ed8-5c0c4719af59 41190-462 HUMAN OTC DRUG ShopRite Allergy Relief diphenhydramine HCl CAPSULE ORAL 20160912 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41190-466_77117295-9816-46c3-82f8-06b4949e9293 41190-466 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20160217 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 41190-467_55052e2d-7016-47fb-a110-415786de8e83 41190-467 HUMAN OTC DRUG ShopRite Aspirin Aspirin TABLET, CHEWABLE ORAL 20161017 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ASPIRIN 81 mg/1 N 20181231 41190-468_a14e1204-3f45-41bc-b449-8819d402ea10 41190-468 HUMAN OTC DRUG ShopRite Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20170110 OTC MONOGRAPH FINAL part331 Wakefern Food Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 41190-469_1b8d30e8-0bc3-494f-be34-08bfda462893 41190-469 HUMAN OTC DRUG ShopRite Stomach Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20161129 OTC MONOGRAPH FINAL part335 Wakefern Food Corporation BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 41190-475_2aed196f-8b51-4b3d-a01e-f1bf79f27a0e 41190-475 HUMAN OTC DRUG ShopRite Childrens Allergy Cetirizine HCl SOLUTION ORAL 20160215 ANDA ANDA204226 Wakefern Food Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 41190-477_2ebd34f1-ddf5-43cc-a026-72a95e3ad3ee 41190-477 HUMAN OTC DRUG ShopRite Fiber Laxative Calcium polycarbophil TABLET, FILM COATED ORAL 20130716 OTC MONOGRAPH NOT FINAL part334 Wakefern Food Corporation CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 41190-478_5fa3dbf3-2546-4020-bdea-2bd631d0d266 41190-478 HUMAN OTC DRUG ShopRite Antacid calcium carbonate TABLET, CHEWABLE ORAL 20161226 OTC MONOGRAPH FINAL part331 Wakefern Food Corporation CALCIUM CARBONATE 500 mg/1 N 20181231 41190-479_b76d961a-0590-4f4d-a757-e520a315adcc 41190-479 HUMAN OTC DRUG ShopRite Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20160913 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41190-484_896870d6-6e66-4b58-b993-32864f93b6d6 41190-484 HUMAN OTC DRUG ShopRite Non-Aspirin Acetaminophen TABLET ORAL 20090902 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 500 mg/1 N 20181231 41190-485_a9a5f2ca-ff69-4544-8c46-aae2ee5f631a 41190-485 HUMAN OTC DRUG ShopRite Antacid calcium carbonate TABLET, CHEWABLE ORAL 20170110 OTC MONOGRAPH FINAL part331 Wakefern Food Corporation CALCIUM CARBONATE 500 mg/1 N 20181231 41190-486_1c16bc54-a366-4275-8e32-744d1f360ceb 41190-486 HUMAN OTC DRUG ShopRite Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20130828 OTC MONOGRAPH NOT FINAL part334 Wakefern Food Corporation DOCUSATE SODIUM 100 mg/1 N 20181231 41190-489_5d1d9d4f-4b12-4ad6-ac91-204074bcb256 41190-489 HUMAN OTC DRUG ShopRite Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20170110 OTC MONOGRAPH FINAL part331 Wakefern Food Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 41190-503_c9439cc8-7841-4e13-b087-b405f46e5e30 41190-503 HUMAN OTC DRUG Complete Beauty Octinoxate, zinc oxide LOTION TOPICAL 20130109 OTC MONOGRAPH FINAL part352 Wakefern Food Corporation OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 41190-516_1c5385fc-ec4a-4a48-b6b1-4467666775f2 41190-516 HUMAN OTC DRUG ShopRite Adult Tussin Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20130806 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 41190-517_7380ee70-3cec-42b5-be89-3c830ec8e9d7 41190-517 HUMAN OTC DRUG ShopRite Ibuprofen IB Ibuprofen TABLET, FILM COATED ORAL 20130806 ANDA ANDA077349 Wakefern Food Corporation IBUPROFEN 200 mg/1 N 20181231 41190-520_f5dc9fe4-18fb-4751-adc9-85eb93b1bec5 41190-520 HUMAN OTC DRUG ShopRite Non-Aspirin Acetaminophen TABLET ORAL 20161207 OTC MONOGRAPH NOT FINAL part343 Wakefern Food Corporation ACETAMINOPHEN 325 mg/1 N 20181231 41190-536_e69d9ce4-4de3-43df-a3a3-b8bf803582f5 41190-536 HUMAN OTC DRUG shoprite bacitracin Bacitracin OINTMENT TOPICAL 20150916 OTC MONOGRAPH FINAL part333B Wakefern Food Corporation BACITRACIN 500 [USP'U]/g N 20181231 41190-544_d45414e2-7b5a-442b-bf7c-21c8254f0da6 41190-544 HUMAN OTC DRUG ShopRite Arthritis Pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130806 ANDA ANDA075077 Wakefern Food Corporation ACETAMINOPHEN 650 mg/1 N 20181231 41190-548_a8502fc5-7263-421e-92b1-02e65575de97 41190-548 HUMAN OTC DRUG shoprite day calm severe acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140917 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41190-571_33910e31-1bf5-4470-b9a2-a5be65455dd0 41190-571 HUMAN OTC DRUG ShopRite Aller Ease fexofenadine hcl TABLET, FILM COATED ORAL 20130709 ANDA ANDA076447 Wakefern Food Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 41190-575_614e876b-50de-483e-b310-d5567344afca 41190-575 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 41190-595_0ecca995-badf-46e2-acfb-36271a01ee98 41190-595 HUMAN OTC DRUG ShopRite Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20170130 OTC MONOGRAPH FINAL part331 Wakefern Food Corporation CALCIUM CARBONATE 1000 mg/1 N 20181231 41190-602_37202c5b-d76f-466c-9c3f-378ffcb3a893 41190-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part334 Wakefern Food Corp MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 41190-603_edd11efa-fc76-4e59-9231-766bf43974cb 41190-603 HUMAN OTC DRUG ShopRite Day Calm Severe acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20140903 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 41190-604_664a66eb-d30e-47de-98d2-e124aa8dbd8b 41190-604 HUMAN OTC DRUG ShopRite Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130806 ANDA ANDA072096 Wakefern Food Corporation IBUPROFEN 200 mg/1 N 20181231 41190-612_97fcbb25-b1ca-4a8b-8cb1-b8925676f0d1 41190-612 HUMAN OTC DRUG ShopRite Allergy Relief Loratadine TABLET ORAL 20130806 ANDA ANDA076301 Wakefern Food Corporation LORATADINE 10 mg/1 N 20181231 41190-619_b69241c6-9944-4b19-ac98-fbf5d1829027 41190-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20100614 OTC MONOGRAPH FINAL part347 Wakefern Food Corp DIMETHICONE 1.3 kg/100mL N 20181231 41190-622_bc88be4a-77f2-4042-8f53-363709b8af77 41190-622 HUMAN OTC DRUG ShopRite Anti Itch Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20131118 OTC MONOGRAPH NOT FINAL part348 Wakefern Food Corporation DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 41190-641_87ae1c96-b4d6-42bf-bc63-599480635705 41190-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 41190-647_a49ab785-ddb8-4285-a4f2-1f2c5638308b 41190-647 HUMAN OTC DRUG shoprite ibuprofen Ibuprofen TABLET, COATED ORAL 20130806 ANDA ANDA072096 Wakefern Food Corporation IBUPROFEN 200 mg/1 N 20181231 41190-648_05ba40d1-6ae2-424e-bb12-591a9b34ecf0 41190-648 HUMAN OTC DRUG shoprite nasal four Phenylephrine hydrochloride SPRAY NASAL 20140917 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 41190-656_2910a0b2-c6ee-4166-81d3-3d022c032387 41190-656 HUMAN OTC DRUG ShopRite Day Calm acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20130620 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 41190-660_93904e1c-d20a-4ef6-b1c4-79bdf87984de 41190-660 HUMAN OTC DRUG ShopRite Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20130620 ANDA ANDA074937 Wakefern Food Corporation IBUPROFEN 100 mg/5mL N 20181231 41190-664_e4e70eb2-24de-4d10-9721-c7f8b3fae3bd 41190-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19951002 OTC MONOGRAPH NOT FINAL part356 Wakefern Food Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41190-667_b0215527-0117-4d2e-8901-e6e9a43b6de1 41190-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19890715 OTC MONOGRAPH FINAL part334 Wakefern Foods Corporation MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 41190-668_44585c81-6358-41c1-b6ba-0b274e16aa51 41190-668 HUMAN OTC DRUG ShopRite Ni Calm Cough Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20130627 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 41190-679_69666ad4-42a9-4868-8fb6-2fb7eb1c0682 41190-679 HUMAN OTC DRUG shoprite triple antibiotic Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20140123 OTC MONOGRAPH FINAL part333B Wakefern Food Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 41190-686_64c5a90a-3154-475a-ac34-2f88594cda40 41190-686 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19890715 OTC MONOGRAPH NOT FINAL part334 Wakefern Food Corporation MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 41190-703_37eacc4d-f3d9-4fb0-ac5d-b55e2e5adf0d 41190-703 HUMAN OTC DRUG ShopRite Gas Relief Simethicone EMULSION ORAL 20140708 OTC MONOGRAPH FINAL part332 Wakefern Food Corporation DIMETHICONE 20 mg/.3mL N 20181231 41190-731_d23e229e-247d-4feb-b296-fd8bba2e11cd 41190-731 HUMAN OTC DRUG Miconazole 3 Combination Pack Miconazole Nitrate KIT 20070529 20180228 ANDA ANDA074926 Wakefern Food Corporation N 20181231 41190-763_71e16165-2bb2-4eeb-8a5e-15880885e40d 41190-763 HUMAN OTC DRUG shoprite ni calm Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140922 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 41190-799_68085fb6-9197-4cda-9723-c6657df51c04 41190-799 HUMAN OTC DRUG ShopRite Adult Tussin Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20130620 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 41190-804_31364c94-67f7-4609-be53-7df4be043f57 41190-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20101130 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corp ISOPROPYL ALCOHOL .91 mg/mL N 20181231 41190-822_bd25386d-9e8f-4ef8-b868-e733629e6bb7 41190-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Wakefern Food Corp WITCH HAZEL 86 kg/100L N 20181231 41190-831_d8a9f42d-6978-42f4-b2de-6fe5203f540e 41190-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part334 WAKEFERN FOOD CORPORATION MINERAL OIL 999 mg/mL N 20181231 41190-851_d538e2cb-3cfe-4d59-afc6-352e4ba8d2a2 41190-851 HUMAN OTC DRUG shoprite antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20130826 OTC MONOGRAPH FINAL part332 Wakefern Food Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 41190-852_05ec458b-c003-4176-9501-49983a7d460b 41190-852 HUMAN OTC DRUG ShopRite Acid Reducer Maximum Strength Ranitidine TABLET, FILM COATED ORAL 20130616 ANDA ANDA091429 Wakefern Food Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 41190-871_39937f44-dea6-4cd5-876a-3b3e0e850470 41190-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE LIQUID TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Wakefern Food Corporation HYDROGEN PEROXIDE .3 kg/100L N 20181231 41190-882_a16907fc-d3cb-410c-a8ee-c47b0d2cd827 41190-882 HUMAN OTC DRUG ShopRite Infants Simethicone Simethicone EMULSION ORAL 20130616 OTC MONOGRAPH FINAL part332 Wakefern Food Corporation DIMETHICONE 20 mg/.3mL N 20181231 41190-897_77e456c3-ac95-41d4-bd7c-d807de59690d 41190-897 HUMAN OTC DRUG ShopRite Ibuprofen Ibuprofen SUSPENSION ORAL 20140512 ANDA ANDA074937 Wakefern Food Corporation IBUPROFEN 100 mg/5mL N 20181231 41190-898_6fa35dfa-6cc1-42ae-a24b-929ad6da76e8 41190-898 HUMAN OTC DRUG shoprite esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170926 ANDA ANDA207193 Wakefern Food Corporation ESOMEPRAZOLE 20 mg/1 N 20181231 41190-903_5428e25b-48d3-499f-88a5-cb8890914819 41190-903 HUMAN OTC DRUG ShopRite Childrens Multi Symptom Cold Relief Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20130814 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 41190-906_d31474d3-2adc-439e-9e43-0297545b355d 41190-906 HUMAN OTC DRUG ShopRite Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20130709 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 41190-915_b1e6e4a2-3869-471e-9d68-09cb0eb17554 41190-915 HUMAN OTC DRUG ShopRite Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20130806 NDA NDA022032 Wakefern Food Corporation OMEPRAZOLE 20 mg/1 N 20181231 41190-931_1f7cc939-c032-41ad-bf36-e467385c5f88 41190-931 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19980815 OTC MONOGRAPH FINAL part358H Wakefern Food Corp PYRITHIONE ZINC 1 g/100mL N 20181231 41190-941_c50bc11b-47f3-4048-b8b3-a975136f9651 41190-941 HUMAN OTC DRUG 2 in 1 Dandruff Pyrithione zinc SHAMPOO TOPICAL 20140716 OTC MONOGRAPH FINAL part358H Wakefern Food Corp PYRITHIONE ZINC 1 g/mL N 20181231 41190-944_3d09d703-532e-4b1b-92a5-a76bccb29db6 41190-944 HUMAN OTC DRUG ShopRite Day Calm Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20130705 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41190-947_8d4ea90f-e63a-483e-94aa-21e0e9f39735 41190-947 HUMAN OTC DRUG Oil Free Acne Wash Salicylic Acid 2% LOTION TOPICAL 20100209 OTC MONOGRAPH FINAL part333D Wakefern SALICYLIC ACID 20.6 mg/mL N 20181231 41190-950_c4a9ad72-23d9-429f-96d4-101c080fbebd 41190-950 HUMAN OTC DRUG ShopRite Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130620 ANDA ANDA091429 Wakefern Food Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 41190-951_578b2264-5090-4f00-930e-f9c1bd2a552f 41190-951 HUMAN OTC DRUG Instant Hand sanitizer ALCOHOL GEL TOPICAL 20110429 OTC MONOGRAPH NOT FINAL part333A WakeFern Food Corporation ALCOHOL 65 kg/100L N 20181231 41190-973_1fbd0af1-9421-478f-8f4c-507d4370a227 41190-973 HUMAN OTC DRUG shoprite hydrocortisone hydrocortisone CREAM TOPICAL 20171127 OTC MONOGRAPH NOT FINAL part348 Wakefern Food Corporation HYDROCORTISONE 1 g/100g N 20181231 41190-987_cfbfc4f6-3d35-4aae-a2e0-abda29b637f7 41190-987 HUMAN OTC DRUG ShopRite Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20130828 OTC MONOGRAPH FINAL part341 Wakefern Food Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 41226-686_956c4d07-d995-46d8-9465-d1576fc5db2f 41226-686 HUMAN OTC DRUG LORATADINE LORATADINE CAPSULE, LIQUID FILLED ORAL 20170426 ANDA ANDA206214 KROGER COMPANY LORATADINE 10 mg/1 N 20181231 41250-000_e876428c-7ff3-4392-8072-00f2648cafe0 41250-000 HUMAN OTC DRUG MEIJER AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 41250-001_fb0af682-b24a-4c17-9522-f3bdb5c50182 41250-001 HUMAN OTC DRUG Meijer SPF 8 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; OCTOCRYLENE; OXYBENZONE .5; 2; 1.5 mL/100mL; mL/100mL; mL/100mL N 20181231 41250-003_e75d7a57-6bb0-4808-aa2f-0e5d4080530c 41250-003 HUMAN OTC DRUG Meijer Baby SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 41250-004_909b5d34-dbb9-4ab1-b52e-f85c67a072bc 41250-004 HUMAN OTC DRUG Anticavity Rinse Sodium Fluoride MOUTHWASH ORAL 20020627 OTC MONOGRAPH FINAL part355 Meijer Distribution, Inc. SODIUM FLUORIDE .05 kg/100L N 20191231 41250-005_894fe45a-0ea4-42dd-b807-b3ed5e9f3ff6 41250-005 HUMAN OTC DRUG Meijer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 41250-006_122dc8d1-1afe-4307-8863-6a519aa65432 41250-006 HUMAN OTC DRUG Meijer AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 41250-007_a095a65f-70b9-406b-8577-a2241d9f2f43 41250-007 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20080815 OTC MONOGRAPH FINAL part333D Meijer Distribution, Inc SALICYLIC ACID 19.8 mg/g N 20181231 41250-009_5c6108d0-0e87-45ef-ab95-f3ebcdce8d27 41250-009 HUMAN OTC DRUG Meijer SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 41250-010_eb437f9b-f788-46a3-9524-03f80be0e92a 41250-010 HUMAN OTC DRUG Meijer Sport SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 41250-011_008a8286-b3b8-4ee8-9ed8-fab738c9125d 41250-011 HUMAN OTC DRUG Hand Sanitizer ALCOHOL GEL TOPICAL 20160121 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc ALCOHOL 558 mg/mL N 20181231 41250-011_4f69ad56-7277-45c3-950b-23d57592d7e8 41250-011 HUMAN OTC DRUG Meijer kids SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 41250-012_eb251ce8-4b84-48c6-b7f2-9cb6a6b8fc57 41250-012 HUMAN OTC DRUG Meijer Oil Free 30 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 5; 3 mL/100mL; mL/100mL; mL/100mL N 20181231 41250-013_d64bfc9b-2088-4b4b-860e-7f186d9a3483 41250-013 HUMAN OTC DRUG Meijer Tropical SPF 4 OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTOCRYLENE; OXYBENZONE 1; .5 mL/100mL; mL/100mL N 20181231 41250-015_3059d7e8-1748-400b-918d-3dcc98d71229 41250-015 HUMAN PRESCRIPTION DRUG Meijer Oil Free SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 41250-016_033d3955-9409-42f3-a960-39f962eed612 41250-016 HUMAN OTC DRUG Meijer Oil Free Faces SPF 30 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 5; 3 mL/100mL; mL/100mL; mL/100mL N 20181231 41250-017_ca8e36f2-8b90-4872-85bc-512ded8d9b26 41250-017 HUMAN OTC DRUG Meijer SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 41250-018_cce5d379-b550-4149-8d7f-fcb53567c6b4 41250-018 HUMAN OTC DRUG meijer Itch and Rash Relief Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc HYDROCORTISONE 1 g/100g N 20181231 41250-019_acd2b634-b913-447a-b002-5ee1640f5cfa 41250-019 HUMAN OTC DRUG Meijer Sheer SPF 55 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.8; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 41250-020_4020e419-7e0f-412d-a11c-cfcc5d76707d 41250-020 HUMAN OTC DRUG Meijer Sheer SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 41250-021_c4a3ede4-0b5d-486f-aa59-dfc4d072014a 41250-021 HUMAN OTC DRUG Meijer Sport SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 41250-023_066ec766-8049-4d09-adee-ce6292690e41 41250-023 HUMAN OTC DRUG Meijer Suscreen SPF 8 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g N 20181231 41250-024_a2a95353-8f9d-4ac7-b3ca-bbeca4fc9903 41250-024 HUMAN OTC DRUG Vaporizing Camphor LIQUID RESPIRATORY (INHALATION) 20110722 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc CAMPHOR (NATURAL) 62 mg/mL N 20181231 41250-025_114643b7-ddd8-4040-b632-b57ca75d4e9e 41250-025 HUMAN OTC DRUG Meijer Sunscreen SPF 15 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g N 20181231 41250-026_6b22e27b-14dc-43b2-afdb-32c3f94086b4 41250-026 HUMAN OTC DRUG MEIJER Sport SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 41250-028_82393b8e-4c93-4965-8165-b779693c22ce 41250-028 HUMAN OTC DRUG Meijer Burn Relief Aloe Vera Pain Relieving Gel LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 41250-029_6f2d93b8-ee7c-4bb2-b8ca-81c8b4cf94de 41250-029 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050206 ANDA ANDA076775 Meijer Distribution Inc NICOTINE 2 mg/1 N 20181231 41250-030_8baa2976-f084-4240-ad01-c3fcf7ae0dec 41250-030 HUMAN OTC DRUG Meijer Oil Free SPF 15 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTINOXATE; OXYBENZONE 7.5; 2.5 g/100g; g/100g N 20181231 41250-031_d9bf2076-4d3f-4118-ab38-54ab61631716 41250-031 HUMAN OTC DRUG NiteTime Cough DayTime Cough dextromethorphan HBr, doxylamine succinate KIT 20130213 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc N 20181231 41250-031_e49d96a0-eaeb-40a3-bebc-dd80a44039a3 41250-031 HUMAN OTC DRUG day time nitetime cough dextromethorphan hbr, doxylamine succinate KIT 19920110 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc N 20181231 41250-032_2be93f37-029f-3eef-e054-00144ff88e88 41250-032 HUMAN OTC DRUG flavor chews calcium carbonate TABLET, CHEWABLE ORAL 20150221 OTC MONOGRAPH FINAL part331 Meijer CALCIUM CARBONATE 750 mg/1 N 20181231 41250-032_cef764e7-8518-42cb-8c43-070e4f6994b9 41250-032 HUMAN OTC DRUG Meijer Sport SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 41250-033_aefa79bb-a0bb-4dbe-b0be-d80843dbf070 41250-033 HUMAN OTC DRUG Meijer Oil Free SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 41250-034_d04852ed-6d8d-428e-9ea7-81ac42786afc 41250-034 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19920915 OTC MONOGRAPH FINAL part347 Meijer Distribution FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 41250-035_499610fd-adb3-411e-92f2-c9596916b50a 41250-035 HUMAN OTC DRUG MEIJER AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 4.5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 41250-036_e4635e56-d04d-4041-acbb-8d56901e4742 41250-036 HUMAN OTC DRUG MEIJER OIL FREE FACES SPF 30 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 5; 3 g/100g; g/100g; g/100g N 20181231 41250-037_8e7dd260-ef45-475e-b4fd-dc4539de6075 41250-037 HUMAN OTC DRUG MEIJER ALOE GEL LIDOCAINE, MENTHOL GEL TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc LIDOCAINE; MENTHOL .7; .2 g/100g; g/100g N 20181231 41250-038_c7cd8e90-5f43-45e4-ac23-37a556ee00e1 41250-038 HUMAN OTC DRUG MEIJER CLEAR ZINC SPF 50 OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTOCRYLENE; ZINC OXIDE 4; 5 g/100g; g/100g N 20181231 41250-039_99218410-b086-4147-b025-926df02de19c 41250-039 HUMAN OTC DRUG MEIJER SPF 4 TANNING OIL OCTINOXATE, PADIMATE O LOTION TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc OCTINOXATE; PADIMATE O 2; 1.4 g/100g; g/100g N 20181231 41250-040_16307cc4-5c83-4dd5-91df-8c67007fe14d 41250-040 HUMAN OTC DRUG Alcohol Extra-Thick Isopropyl Alcohol SWAB TOPICAL 20110406 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution Inc ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 41250-042_c687f9a0-bf2e-4d48-a34b-f4fa7f91a09f 41250-042 HUMAN OTC DRUG MEIJER SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 41250-043_825ba381-22cf-46de-a739-35293373a77c 41250-043 HUMAN OTC DRUG Body Menthol POWDER TOPICAL 19871115 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution, Inc MENTHOL 1.5 mg/g N 20181231 41250-044_16e9f88a-7690-4814-a521-208f8b23e388 41250-044 HUMAN OTC DRUG nighttime sleep aid Diphenhydramine HCl SOLUTION ORAL 20141204 OTC MONOGRAPH FINAL part338 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 41250-045_d3116b03-4375-405d-a0f9-f5d7a4486767 41250-045 HUMAN OTC DRUG Clean Apple Pyrithione zinc SHAMPOO TOPICAL 20131213 OTC MONOGRAPH FINAL part358H Meijer Distribution PYRITHIONE ZINC 1 g/mL N 20181231 41250-048_e0c6cf46-d7b7-440b-b4cc-000e79e87df4 41250-048 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20150228 ANDA ANDA078682 MEIJER, INC. IBUPROFEN 200 mg/1 N 20181231 41250-049_2d31e18d-fb91-4b4f-bbb1-424e6f07e1bd 41250-049 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20141031 OTC MONOGRAPH FINAL part341 MEIJER, INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41250-050_7ef464e5-ebca-407e-8899-4a6b8d4d1a22 41250-050 HUMAN OTC DRUG Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, FILM COATED ORAL 20090408 ANDA ANDA079113 Meijer Distribution Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 41250-051_aa538d88-0eda-45e1-b81e-bee3c4cc96e0 41250-051 HUMAN OTC DRUG Salicylic Acid Wart Remover Gel GEL TOPICAL 20150615 OTC MONOGRAPH FINAL part358B Meijer Distribution Inc SALICYLIC ACID .17 g/7g N 20181231 41250-053_9a858d0a-0412-4d16-a8fc-f17e8ee6a989 41250-053 HUMAN OTC DRUG allergy relief Fexofenadine HCl TABLET, FILM COATED ORAL 20150130 ANDA ANDA076447 Meijer Distribution Inc FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 41250-054_2665f956-f944-4097-b6cd-e49de23fa91a 41250-054 HUMAN OTC DRUG 12 hour decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19991105 ANDA ANDA075153 Meijer Distribution Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 41250-055_ee845b94-1461-44e8-884d-1d50de79e51b 41250-055 HUMAN OTC DRUG meijer REGULAR SCENT Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution Inc. BENZALKONIUM CHLORIDE .115 g/1 N 20181231 41250-057_571c0d65-4083-416c-846f-bed0ebf5027f 41250-057 HUMAN OTC DRUG ibuprofen infants ibuprofen SUSPENSION ORAL 20000317 ANDA ANDA075217 Meijer Distribution Inc IBUPROFEN 50 mg/1.25mL N 20181231 41250-058_cb0eeaee-45d5-42d9-ac55-e069164d5129 41250-058 HUMAN OTC DRUG Diphenhydramine HCl and Zinc Acetate Extra Strength Itch Relief SPRAY TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.52; .076 g/76g; g/76g N 20181231 41250-059_fa1db369-fd64-42ad-942e-f6f9abf6128e 41250-059 HUMAN OTC DRUG Healing Petrolatum OINTMENT TOPICAL 20130801 OTC MONOGRAPH FINAL part347 Meijer Distribution, Inc PETROLATUM 340 mg/g N 20181231 41250-060_9cce6520-b8f7-4140-80c8-8a541e115b2d 41250-060 HUMAN OTC DRUG allergy relief fexofenadine hcl TABLET, FILM COATED ORAL 20150302 ANDA ANDA076447 Meijer Distribution Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 41250-062_125123a6-bd33-4438-a06f-28635f1a516f 41250-062 HUMAN OTC DRUG meijer Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 Meijer Distribution Inc CLOTRIMAZOLE 2 g/100g N 20181231 41250-063_86f19c2d-aa84-4be8-a286-bc36284f0b97 41250-063 HUMAN OTC DRUG meijer Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc HYDROCORTISONE 1 g/100g N 20181231 41250-064_7e5c4f4f-4ef5-156b-3236-94459e5747ce 41250-064 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20140922 ANDA ANDA078878 Meijer Distribution Inc OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 41250-065_36632976-2769-4f57-8064-6359f755d0b3 41250-065 HUMAN OTC DRUG nasal 12 hour Oxymetazoline HCl SPRAY NASAL 19940503 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41250-066_304ff4db-201b-60a4-e054-00144ff8d46c 41250-066 HUMAN OTC DRUG Mixed Berry Sore Throat and Cough lozenge Dextromethorphan Hydrobromide LOZENGE ORAL 20160412 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution, Inc. BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20181231 41250-067_edcb423e-b5c2-4e26-8f7f-9b9ee575042c 41250-067 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20150402 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 41250-068_2f6de590-7cae-25d7-e054-00144ff8d46c 41250-068 HUMAN OTC DRUG Cherry Sore Throat Lozenges Benzocaine, Menthol LOZENGE ORAL 20160401 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution Inc. BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 41250-069_26d2d7f8-521a-40d8-a9ae-b988cdc94ee9 41250-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19950407 OTC MONOGRAPH FINAL part347 Meijer Distribution Inc PETROLATUM 1 g/g N 20181231 41250-070_0f8864f1-7bc6-4ffa-ad7f-118d2f1f5340 41250-070 HUMAN OTC DRUG Creamy Petroleum White petrolatum JELLY TOPICAL 20090129 OTC MONOGRAPH FINAL part347 Meijer Distribution, Inc PETROLATUM .3 mg/100g E 20171231 41250-071_36de9b53-4000-4fb9-ab79-7b0c478ef7fa 41250-071 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20150210 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 41250-072_209da88d-b15b-4d07-b0dc-cdbbe8eb8d1e 41250-072 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 19961223 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .06; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41250-073_b5aafc5b-cc3b-4bf1-ab4a-874042dd758b 41250-073 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA021920 MEIJER, INC. NAPROXEN SODIUM 220 mg/1 N 20181231 41250-074_8d4cb97a-3b36-423e-85f2-75d23a675601 41250-074 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 20060621 ANDA ANDA077349 Meijer Distribution Inc IBUPROFEN 200 mg/1 N 20181231 41250-075_cb8723f3-9b72-442e-a153-fc91238cad77 41250-075 HUMAN OTC DRUG meijer Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc BACITRACIN ZINC 500 [iU]/g N 20181231 41250-076_7c740786-2e2e-41e8-a20c-5cbd4d129741 41250-076 HUMAN OTC DRUG Meijer Cherry Cough Drops MENTHOL LOZENGE ORAL 20140505 OTC MONOGRAPH FINAL part341 Meijer Distribution, Inc MENTHOL 5.8 mg/1 N 20181231 41250-077_d5a15987-b28a-43e9-b1bc-340e49032c4d 41250-077 HUMAN OTC DRUG Meijer Honey Lemon Cough Drops MENTHOL LOZENGE ORAL 20140506 OTC MONOGRAPH FINAL part341 Meijer Distribution, Inc MENTHOL 7.5 mg/1 N 20181231 41250-078_653de601-2329-4f60-a7a7-c3db932c42fd 41250-078 HUMAN OTC DRUG Meijer Menthol Cough Drops MENTHOL LOZENGE ORAL 20140506 OTC MONOGRAPH FINAL part341 Meijer Distribution, Inc MENTHOL 5.4 mg/1 N 20181231 41250-079_bcb22048-effc-4f06-bace-841d9f76f6de 41250-079 HUMAN OTC DRUG Meijer Softchews calcium carbonate BAR, CHEWABLE ORAL 20140604 OTC MONOGRAPH FINAL part331 MEIJER DISTRIBUTION, INC CALCIUM CARBONATE 1177 mg/1 N 20181231 41250-080_a5febf1a-ea58-4d12-92c7-22c169a7c0fa 41250-080 HUMAN OTC DRUG Antifungal Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Meijer Distribution Inc TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 41250-081_24a26529-4d3d-44a8-a59a-3335126e971b 41250-081 HUMAN OTC DRUG miconazole 3 Miconazole nitrate KIT 20000204 ANDA ANDA075329 Meijer Distribution Inc N 20181231 41250-082_5bac504f-b650-813d-e053-2991aa0aea93 41250-082 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20140610 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc. MENTHOL 5.4 mg/1 N 20181231 41250-082_5bacae54-b08f-3953-e053-2a91aa0a691c 41250-082 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20140609 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc. MENTHOL 5.4 mg/1 N 20181231 41250-084_46d6ded4-ce2c-422c-a47b-4c9b6d65f86c 41250-084 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20151130 OTC MONOGRAPH NOT FINAL part334 MEIJER, INC. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 41250-085_8d0014e0-23e5-4d09-929d-aeed66329b36 41250-085 HUMAN OTC DRUG Childrens 24 hour allergy Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Meijer Distribution Inc LORATADINE 5 mg/5mL N 20181231 41250-086_463a36a6-39a3-42d1-8a22-4d46027e0242 41250-086 HUMAN OTC DRUG Senna laxative Sennosides TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 MEIJER, INC. SENNOSIDES 8.6 mg/1 N 20181231 41250-087_59bf0aa6-c3dc-454c-afdf-0aa7f7f91397 41250-087 HUMAN OTC DRUG Undecylenic Acid Antifungal Pen LIQUID TOPICAL 20140319 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc UNDECYLENIC ACID 25 mg/1.7mL N 20181231 41250-088_602c529d-16ff-5011-e053-2a91aa0a0295 41250-088 HUMAN OTC DRUG Meijer Triple Antibiotic Plus Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine HCI OINTMENT TOPICAL 20150114 OTC MONOGRAPH FINAL part333B Meijer, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 41250-089_ebf04ca7-39e0-4dce-97ea-87b24ee2eb5d 41250-089 HUMAN OTC DRUG meijer anti-itch diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH FINAL part348 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 41250-090_74f85ea5-af0a-474c-aab7-1dc1945434c1 41250-090 HUMAN OTC DRUG daytime nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110429 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc N 20181231 41250-090_9465174d-1a95-4965-a945-ecaa5d9d8bde 41250-090 HUMAN OTC DRUG daytime nitetime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140211 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc N 20181231 41250-090_cfe5f076-3d70-4608-98c7-da73bbb7d89c 41250-090 HUMAN OTC DRUG DayTime NiteTime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20070810 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc N 20181231 41250-091_741f55d0-2f8a-4722-8908-059ff18b2a58 41250-091 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20080408 OTC MONOGRAPH FINAL part347 Meijer LANOLIN; PETROLATUM 133; 459 mg/g; mg/g N 20181231 41250-092_61d25a74-7844-2c2e-e053-2991aa0a0fa2 41250-092 HUMAN OTC DRUG Herbal Cough Drop Menthol LOZENGE ORAL 20160512 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc. MENTHOL 4.8 mg/1 N 20191231 41250-093_548c169a-6309-4edb-beab-8fbf0297dadf 41250-093 HUMAN OTC DRUG Aloe Vera Gel Lidocaine HCl GEL TOPICAL 20160829 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution LIDOCAINE HYDROCHLORIDE 2.5 g/g N 20181231 41250-094_2768f4ec-e9ce-4b3c-b908-3e4c42cabe31 41250-094 HUMAN OTC DRUG Nasal Decongestant PE Maximum Strength Phenylephrine Hydrochloride TABLET ORAL 20050406 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 41250-095_32ab2c93-3c4f-47ea-e054-00144ff8d46c 41250-095 HUMAN OTC DRUG Throat Relief Pops Pectin LOZENGE ORAL 20160512 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution Inc. PECTIN 10 mg/1 N 20181231 41250-096_3beb4ddf-cf91-433f-e054-00144ff88e88 41250-096 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20140609 OTC MONOGRAPH FINAL part341 Meijer MENTHOL 5.8 mg/1 N 20181231 41250-096_3c17a1c4-a978-5206-e054-00144ff8d46c 41250-096 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20140528 OTC MONOGRAPH FINAL part341 Meijer MENTHOL 5.8 mg/1 N 20181231 41250-097_3bed63d5-8045-5672-e054-00144ff8d46c 41250-097 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20140609 OTC MONOGRAPH FINAL part341 Meijer MENTHOL 7.5 mg/1 N 20181231 41250-098_c185527d-22dc-4946-8530-e4a99dcf0cd6 41250-098 HUMAN OTC DRUG Miconazole nitrate Antifungal Miconazole Liquid Continuous Spray AEROSOL, SPRAY TOPICAL 20120413 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc MICONAZOLE NITRATE 3 g/150g N 20181231 41250-099_adcef4da-6521-4766-9f8e-a7161526504d 41250-099 HUMAN OTC DRUG meijer Hydrocortisone Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc HYDROCORTISONE 1 g/100g N 20181231 41250-100_3c8cd0c9-68a4-744f-e054-00144ff88e88 41250-100 HUMAN OTC DRUG SF Cherry Cough Drop Menthol LOZENGE ORAL 20140609 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc. MENTHOL 5.8 mg/1 N 20181231 41250-101_02c3a513-fe3a-4691-949e-eff61300285e 41250-101 HUMAN OTC DRUG NiteTime Sinus Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100914 OTC MONOGRAPH FINAL part341 MEIJER, INC. ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 41250-102_fc080d56-d4f3-4a35-a46b-d0b18e3c0145 41250-102 HUMAN OTC DRUG Childrens 24 Hour Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 41250-103_fb3d58d0-340a-4736-9357-594aba1f52a4 41250-103 HUMAN OTC DRUG Meijer Sheer Moisturing SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20160310 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 5.5; 4.5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 41250-104_265beead-fa18-4ae7-8336-cb8ca63e36a3 41250-104 HUMAN OTC DRUG Pain Relief acetaminophen CAPSULE, LIQUID FILLED ORAL 20160504 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 325 mg/1 N 20181231 41250-106_689dc410-a14c-42c1-b295-a76a5e47612b 41250-106 HUMAN OTC DRUG Childrens 24 Hour Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 41250-107_dca31eff-ae8d-43e7-8a42-c0f31d0b1e0f 41250-107 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20160207 OTC MONOGRAPH FINAL part338 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41250-108_3ce0c1cd-32dd-4f78-e054-00144ff88e88 41250-108 HUMAN OTC DRUG Assorted Fruit Antacid Flavor Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20150210 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc. CALCIUM CARBONATE 750 mg/1 N 20181231 41250-109_3ce1b794-cdd2-38ee-e054-00144ff8d46c 41250-109 HUMAN OTC DRUG Cherry Antacid Soft Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20140401 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc. CALCIUM CARBONATE 1177 mg/1 N 20181231 41250-111_df0d8f5d-7b4c-4be6-87e0-9d582e3146f0 41250-111 HUMAN OTC DRUG Meijer Enema Saline Laxative ENEMA RECTAL 20130510 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 41250-112_cebb023f-1b63-405a-b256-bab75c5c05f3 41250-112 HUMAN OTC DRUG Meijer Mineral Oil ENEMA RECTAL 20130510 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MINERAL OIL 113.115 g/118mL E 20171231 41250-113_3c052e93-55a6-16ce-e054-00144ff8d46c 41250-113 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20140609 OTC MONOGRAPH FINAL part341 Meijer MENTHOL 5.8 mg/1 N 20181231 41250-114_3c16ea8c-8af2-0843-e054-00144ff88e88 41250-114 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20140609 OTC MONOGRAPH FINAL part341 Meijer MENTHOL 7.5 mg/1 N 20181231 41250-114_3cde2bf8-60bd-5c47-e054-00144ff8d46c 41250-114 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20140529 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc. MENTHOL 7.5 mg/1 N 20181231 41250-115_3c78f482-33ff-7470-e054-00144ff8d46c 41250-115 HUMAN OTC DRUG SF Menthol Cough Drop Menthol LOZENGE ORAL 20140609 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc. MENTHOL 5.8 mg/1 N 20181231 41250-115_3cdfa6df-ce15-301a-e054-00144ff8d46c 41250-115 HUMAN OTC DRUG SF Menthol Cough Drop Menthol LOZENGE ORAL 20150608 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc. MENTHOL 5.8 mg/1 N 20181231 41250-116_3c8f34a5-751e-357f-e054-00144ff8d46c 41250-116 HUMAN OTC DRUG SF Honey Lemon Cough Drops Menthol LOZENGE ORAL 20140609 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc. MENTHOL 7.6 mg/1 N 20181231 41250-117_a50e0ff8-4a2c-4535-9733-901ccac06e99 41250-117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 Meijer Distribution Inc LANSOPRAZOLE 15 mg/1 N 20181231 41250-118_0748e196-7936-61b7-e054-00144ff88e88 41250-118 HUMAN OTC DRUG Aspirin Regular Strength ASPIRIN TABLET, COATED ORAL 20141107 OTC MONOGRAPH NOT FINAL part343 Meijer ASPIRIN 325 mg/1 N 20181231 41250-119_c17d8bef-9dc6-4b08-a251-ebefaf915165 41250-119 HUMAN OTC DRUG Winter Apple Hand Sanitizer GEL TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc ALCOHOL 62 mg/mL N 20181231 41250-120_51da9329-9146-45b2-b49e-2cd2807b81b0 41250-120 HUMAN OTC DRUG Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20140630 OTC MONOGRAPH NOT FINAL part334 MEIJER, INC. BISACODYL 5 mg/1 N 20181231 41250-121_285d3b79-b0c9-4589-adbb-fbc6ba302fa1 41250-121 HUMAN OTC DRUG Meijer AM Facial Moisturizing Broad Spectrum SPF 30 Sunscreen Homosalate, Octinoxate, Octocrylene, and Zinc Oxide LOTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 12; 7.5; 2; 3.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 41250-122_3bd8ddcf-3c25-4415-b783-f28dc2c773d2 41250-122 HUMAN OTC DRUG Cranberry Garland Ethyl Alcohol GEL TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Meijers Distribution, Inc ALCOHOL 62 mg/mL N 20181231 41250-124_3dd08943-ef2f-49b4-a483-eb3fc293252a 41250-124 HUMAN OTC DRUG Antiseptic Rinse Antiseptic MOUTHWASH ORAL 20060808 UNAPPROVED DRUG OTHER Meijer EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 41250-125_6d7262d7-4dad-4983-9951-870abbb944a3 41250-125 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH FINAL part332 MEIJER, INC. DIMETHICONE 180 mg/1 N 20181231 41250-127_3b13b369-cfb1-46d8-8806-1397a904c526 41250-127 HUMAN OTC DRUG Undecylenic Acid Liquid Anti-Fungal Liquid Maximum Strength LIQUID TOPICAL 20140319 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc UNDECYLENIC ACID 7.5 g/30g N 20181231 41250-128_9cef6e7b-a4b8-41e3-b056-8672bc0cd293 41250-128 HUMAN OTC DRUG Salicylic Acid Wart Removers PATCH TOPICAL 20090109 OTC MONOGRAPH FINAL part358B Meijer Distribution Inc SALICYLIC ACID 40 mg/181 N 20181231 41250-129_4bb9ed83-2d5e-4959-e054-00144ff8d46c 41250-129 HUMAN OTC DRUG Cold Relief Lozenges Zinc Gluconate LOZENGE ORAL 20160729 UNAPPROVED HOMEOPATHIC Meijer ZINC GLUCONATE 2 [hp_X]/1 N 20181231 41250-131_cabe7b1b-4c11-11f3-b279-21d271df7cd1 41250-131 HUMAN OTC DRUG Ranitidine 75 Ranitidine Tablets TABLET ORAL 20140922 ANDA ANDA075294 Meijer Distribution Inc RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 41250-132_8d9fa281-cd9c-482f-94b3-04aa5c7cb2b6 41250-132 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20120105 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution Inc BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/10mL; mg/10mL N 20181231 41250-135_4c6e7e63-1548-11d3-e054-00144ff88e88 41250-135 HUMAN OTC DRUG Antacid and Anti-Gas Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20170405 OTC MONOGRAPH FINAL part331 Meijer CALCIUM CARBONATE; DIMETHICONE 750; 80 mg/1; mg/1 N 20181231 41250-136_ab868e2f-b4c9-4763-80bf-266643046315 41250-136 HUMAN OTC DRUG Mucus Relief Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part341 MEIJER, INC. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 41250-137_7be1c1b6-239e-4d7b-8ea5-5aec105660a4 41250-137 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 MEIJER, INC. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 41250-138_34da761f-52a1-2f20-e054-00144ff88e88 41250-138 HUMAN OTC DRUG COLD RELIEF MULTI-SYMPTOM DAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141107 OTC MONOGRAPH FINAL part341 Meijer ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41250-141_6a5ce63f-d12a-4968-944c-59b1cd1d729f 41250-141 HUMAN OTC DRUG acid reducer original strength Famotidine TABLET ORAL 20091014 ANDA ANDA075400 Meijer Distribution Inc FAMOTIDINE 10 mg/1 N 20181231 41250-142_45f0796c-ef87-4a88-b2e5-f98c598bb281 41250-142 HUMAN OTC DRUG Vagicaine Maximum Strength Benzocaine, Resorcinol CREAM TOPICAL 20090515 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g N 20181231 41250-143_f7ecb2af-7929-4433-89c3-3466ef116c92 41250-143 HUMAN OTC DRUG Back and Body Extra Strength Aspirin, Caffeine TABLET, FILM COATED ORAL 20140412 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 N 20181231 41250-144_5fc9648e-981c-4025-8bd7-1a5349ee63d6 41250-144 HUMAN OTC DRUG Mucus D Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20151216 ANDA ANDA091071 Meijer Distribution Inc GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 41250-145_4d76da2b-c81e-2cea-e054-00144ff8d46c 41250-145 HUMAN OTC DRUG Throat Relief Pops Pectin LOZENGE ORAL 20170410 OTC MONOGRAPH NOT FINAL part356 Meijer Corporation PECTIN 10 mg/1 N 20181231 41250-146_34da761f-52b7-2f20-e054-00144ff88e88 41250-146 HUMAN OTC DRUG Aspirin 81mg Adult Low Dose ASPIRIN TABLET, DELAYED RELEASE ORAL 20110401 OTC MONOGRAPH NOT FINAL part343 Meijer ASPIRIN 81 mg/1 N 20181231 41250-148_fe58deeb-7731-482e-91d2-0a02a8396b3f 41250-148 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 N 20181231 41250-149_5bafdd7c-fbc1-4277-e053-2a91aa0aef9c 41250-149 HUMAN OTC DRUG menthol cough drops Menthol LOZENGE ORAL 20171016 OTC MONOGRAPH FINAL part341 Meijer MENTHOL 5.4 mg/1 N 20181231 41250-150_34da6ec8-ec0f-2dbe-e054-00144ff88e88 41250-150 HUMAN OTC DRUG COLD RELIEF MULTI-SYMPTOM Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride KIT 20110601 OTC MONOGRAPH FINAL part341 Meijer N 20181231 41250-153_68dc14c6-c2d9-4920-ad90-2f8c81bbaf77 41250-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 41250-154_c6169d49-657c-4dde-baef-fbaa5a6a9ce8 41250-154 HUMAN OTC DRUG Athletes Foot tolnaftate SPRAY TOPICAL 20041026 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc TOLNAFTATE 1 g/100g N 20181231 41250-158_84f932b6-0aee-4cf9-b4b9-213560c42c1d 41250-158 HUMAN OTC DRUG Congestion Relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20140917 ANDA ANDA203200 Meijer Distribution Inc IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20181231 41250-159_12e46e96-e083-4504-a432-d3020ee0116b 41250-159 HUMAN OTC DRUG Meijer Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Meijer SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 41250-160_9544ad26-33aa-40f6-ac09-14f047006a44 41250-160 HUMAN OTC DRUG Meijer Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Meijer SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 41250-161_47d8c23f-dec6-45ce-8e63-2224a2676644 41250-161 HUMAN OTC DRUG Pain and Fever Acetaminophen SUSPENSION ORAL 20110826 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL N 20181231 41250-162_2821b691-0ecf-0e35-e054-00144ff8d46c 41250-162 HUMAN OTC DRUG Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% LIQUID TOPICAL 20140101 NDA NDA019125 Meijer Distribution, Inc. CHLORHEXIDINE GLUCONATE 4 mg/100mL N 20181231 41250-164_948778cc-1590-4acf-96b4-f4bf1b93817d 41250-164 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 MEIJER, INC. PHENOL 1.4 g/100mL N 20181231 41250-165_63167142-8263-40b1-94ba-e709e146093d 41250-165 HUMAN OTC DRUG Allergy Relief D Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20030605 ANDA ANDA075706 Meijer Distribution Inc PSEUDOEPHEDRINE SULFATE; LORATADINE 240; 10 mg/1; mg/1 N 20181231 41250-166_1858a3c5-d013-4a14-bcaa-500d3eb99a24 41250-166 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110613 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .6 mL/100mL N 20181231 41250-167_4a94616d-7f5f-49d0-8640-cefa8878ddb2 41250-167 HUMAN OTC DRUG MEIJER ANTIBACTERIAL FOAMING TRICLOSAN SOAP TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E MEIJER TRICLOSAN .6 mL/100mL N 20181231 41250-168_5bd61cd4-a5cb-9d66-e053-2a91aa0a93a3 41250-168 HUMAN OTC DRUG sugar free menthol cough drops Menthol LOZENGE ORAL 20171018 OTC MONOGRAPH FINAL part341 Meijer MENTHOL 5.8 mg/1 N 20181231 41250-170_e5b9a532-e777-499d-81de-7cddbb7af08b 41250-170 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050201 ANDA ANDA076789 Meijer Distribution Inc NICOTINE 4 mg/1 N 20181231 41250-171_5bd7c24d-6a62-5d2d-e053-2a91aa0a08ed 41250-171 HUMAN OTC DRUG sugar free honey lemon cough drops Menthol LOZENGE ORAL 20171018 OTC MONOGRAPH FINAL part341 Meijer MENTHOL 7.6 mg/1 N 20181231 41250-173_5dd81bdd-54a0-497b-90ef-6db2ca15f3d4 41250-173 HUMAN OTC DRUG ANTIBACTERIAL FOAMING PLUMERIA TRICLOSAN SOAP TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part333 MEIJER TRICLOSAN .6 mL/100mL N 20181231 41250-176_57a44bb8-1f35-4faa-afdb-4c56c5fb37f4 41250-176 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111021 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .6 mL/100mL N 20181231 41250-177_6f02d6af-d05a-48a9-94c7-2b9b09c1599d 41250-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING ORIGINAL TRICLOSAN LIQUID TOPICAL 20111118 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .46 mL/100mL N 20181231 41250-177_dbc2edd0-7a4d-452b-aec5-a2a08b331f19 41250-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING ORIGINAL TRICLOSAN LIQUID TOPICAL 20111118 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .46 mL/100mL N 20181231 41250-179_61ed92a7-0024-485f-9467-3f1c1ace9642 41250-179 HUMAN OTC DRUG antacid extra strength Calcium carbonate TABLET, CHEWABLE ORAL 19940511 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 750 mg/1 N 20181231 41250-183_01352fe9-793a-4bfe-ace7-3487483b1bce 41250-183 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111021 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .6 mL/100mL N 20181231 41250-185_99d02e5f-1110-44e0-a644-833cce037cef 41250-185 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111021 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .6 mL/100mL N 20181231 41250-186_f9273089-17ca-454a-a2fb-99a476b7ba0b 41250-186 HUMAN OTC DRUG ANTIBACTERIAL FOAMING CRANBERRY TRICLOSAN LIQUID TOPICAL 20111118 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .46 mL/100mL N 20181231 41250-187_00060ff5-c070-42cc-9c37-24fa3808b692 41250-187 HUMAN OTC DRUG ANTIBACTERIAL FOAMING CUCUMBER MELON TRICLOSAN LIQUID TOPICAL 20111117 OTC MONOGRAPH NOT FINAL part333E MEIJER DISTRIBUTION INC TRICLOSAN .6 mL/100mL N 20181231 41250-188_14319ba4-3bce-497c-a380-65bd24defc5d 41250-188 HUMAN OTC DRUG hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140305 OTC MONOGRAPH FINAL part346 Meijer Distribution Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 41250-190_75401466-f378-4e37-8477-31f177c97bc8 41250-190 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20090916 ANDA ANDA090711 Meijer Distribution Inc NICOTINE 4 mg/1 N 20181231 41250-191_fa8695e8-90a5-40ad-b03c-e1913c5b1ac1 41250-191 HUMAN OTC DRUG Bisacody Enteric Coated Bisacodyl TABLET, COATED ORAL 20160531 OTC MONOGRAPH NOT FINAL part334 MEIJER, INC. BISACODYL 5 mg/1 N 20181231 41250-193_70835347-eaa1-4fef-b8ae-2bc5de5d518a 41250-193 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20140430 OTC MONOGRAPH NOT FINAL part343 MEIJER, INC. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 41250-194_61a1ea07-0850-4ba6-863e-b787d9cd74f8 41250-194 HUMAN OTC DRUG Acid Reducer Maximum Strength Famotidine TABLET ORAL 20060929 ANDA ANDA077351 Meijer Distribution Inc FAMOTIDINE 20 mg/1 N 20181231 41250-198_558adf0f-bd18-4902-b6cd-b3b2f4d4fdf7 41250-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100712 ANDA ANDA078682 MEIJER, INC. IBUPROFEN 200 mg/1 N 20181231 41250-199_b9345fa3-14c0-4d8c-b3fc-9f4785d52326 41250-199 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100611 ANDA ANDA079114 Meijer Distribution Inc N 20181231 41250-200_0e1b4d55-e907-4a71-b119-41d025657ba7 41250-200 HUMAN OTC DRUG Meijer Brilliant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Meijer SODIUM FLUORIDE .243 g/100g N 20181231 41250-201_b5d08d4b-7507-4d2a-b850-42b6a8403e7c 41250-201 HUMAN OTC DRUG nicotine Nicotine polarilex LOZENGE ORAL 20100115 ANDA ANDA090821 Meijer Distribution Inc NICOTINE 2 mg/1 N 20181231 41250-202_210aca71-312a-40c0-850f-89056e7350e7 41250-202 HUMAN OTC DRUG hair regrowth treatment for women minoxidil SOLUTION TOPICAL 20110407 ANDA ANDA075357 Meijer Distribution Inc MINOXIDIL 2 g/100mL N 20181231 41250-204_4db261d9-f850-460f-a2b9-3d97bc042944 41250-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Meijer Distribution, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 41250-205_1dbac24b-c8fe-459b-9454-170a14f7aee0 41250-205 HUMAN OTC DRUG Athletes Foot Tolnaftate SPRAY TOPICAL 20041026 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc TOLNAFTATE 1 g/100g N 20181231 41250-206_1214d2b4-126d-42fb-bf10-8691ec5de4d5 41250-206 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050124 ANDA ANDA078325 Meijer Distribution Inc NICOTINE 2 mg/1 N 20181231 41250-209_6627f4e3-1c62-43af-be58-df67f7a2dcaa 41250-209 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20170208 ANDA ANDA206394 Meijer Distribution Inc NICOTINE 2 mg/1 N 20181231 41250-213_93a8e06f-de28-453c-b063-78a1a1ec1945 41250-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20020711 OTC MONOGRAPH FINAL part355 Meijer Distribution, Inc SODIUM FLUORIDE .2 mg/mL N 20181231 41250-214_72498af4-30b6-49f0-b4d8-f9c06bf4791c 41250-214 HUMAN OTC DRUG Meijer Cold and Hot Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Meijer MENTHOL 750 mg/1 N 20181231 41250-215_4a0f5506-1f7f-4281-8f13-038fa5803cb4 41250-215 HUMAN OTC DRUG Meijer Extra Strength Cold and Hot Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Meijer MENTHOL 750 mg/1 N 20181231 41250-216_36c51625-2d48-4f3c-85a2-b197b9cd9324 41250-216 HUMAN OTC DRUG Salicylic Acid One Step Corn Remover PATCH TOPICAL 20120306 OTC MONOGRAPH FINAL part358F Meijer Distribution Inc. SALICYLIC ACID 40 mg/61 N 20181231 41250-218_e59b4e17-f56f-478a-8b27-2a56fc5ff9c2 41250-218 HUMAN OTC DRUG Clear Anti-Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part347 Meijer Distribution, Inc. PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 41250-220_34b663e0-e3d6-366f-e054-00144ff8d46c 41250-220 HUMAN OTC DRUG Pressure and Pain PE ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110801 OTC MONOGRAPH FINAL part341 Meijer ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 41250-223_741961da-a6a6-4353-b068-819e64c3399c 41250-223 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 MEIJER DISTRIBUTION INC ALCOHOL 62 mL/100mL N 20181231 41250-224_31609d95-13e8-4ba5-94e4-762f586471a3 41250-224 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030305 ANDA ANDA075232 Meijer Distribution Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 41250-226_19ed0b96-f258-43e6-a73b-26759f341560 41250-226 HUMAN OTC DRUG Baby Diaper Rash Zinc Oxide OINTMENT TOPICAL 20110901 OTC MONOGRAPH FINAL part347 Meijer Distribution, Inc ZINC OXIDE 130 g/g N 20181231 41250-227_fa0758b4-3d63-465d-8b8d-571bc11e40cb 41250-227 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, COATED ORAL 20050928 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 N 20181231 41250-228_851f32ea-3f89-4f93-b386-20dbdf308fed 41250-228 HUMAN OTC DRUG Salicylic acid One Step Wart Remover Strips PATCH TOPICAL 20120306 OTC MONOGRAPH FINAL part358B Meijer Distribution Inc SALICYLIC ACID 40 mg/141 N 20181231 41250-229_6fdfe2d3-7ce3-45ad-aca9-5ca4b7f54fef 41250-229 HUMAN OTC DRUG Acne Treatment Benzoyl peroxide GEL TOPICAL 20130715 OTC MONOGRAPH FINAL part333D Meijer BENZOYL PEROXIDE 1 mg/g N 20181231 41250-236_5382ebee-0613-4561-99ff-8dff5cd450ab 41250-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 MEIJER, INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 41250-238_a604ec90-08c1-40c8-a306-07001a50bf8f 41250-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20160831 OTC MONOGRAPH NOT FINAL part334 MEIJER, INC. DOCUSATE SODIUM 100 mg/1 N 20181231 41250-239_808843c5-7c3e-4c96-ae5a-4704201ad464 41250-239 HUMAN OTC DRUG Allergy Relief-D 24 Hour Loratadine and Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20160301 ANDA ANDA075706 Meijer Distribution Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 41250-240_aa0d1dd7-da62-4911-8781-8c373f0008d6 41250-240 HUMAN OTC DRUG childrens ibuprofen Ibuprofen SUSPENSION ORAL 20160907 ANDA ANDA074937 Meijer Distribution Inc IBUPROFEN 100 mg/5mL N 20181231 41250-241_ff70bc6d-cf13-4f95-8cc8-8f457911b54c 41250-241 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20120306 OTC MONOGRAPH FINAL part358F Meijer Distribution Inc SALICYLIC ACID 40 mg/91 N 20181231 41250-242_5fa21d27-663c-47e4-9c8a-6145602c9d89 41250-242 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Powder Miconazole Nitrate POWDER TOPICAL 20120306 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc MICONAZOLE NITRATE 1.42 g/71g N 20181231 41250-243_6b21b9d1-7aa6-4b8c-b206-e70168522acc 41250-243 HUMAN OTC DRUG Salicylic Acid Medicated Plantar Wart Remover PATCH TOPICAL 20120105 OTC MONOGRAPH FINAL part358B Meijer Distribution Inc SALICYLIC ACID 40 mg/241 N 20181231 41250-245_28366fdc-dd83-463d-bc66-ad32379d5936 41250-245 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 MEIJER, INC. SENNOSIDES 25 mg/1 N 20181231 41250-247_a557dabc-7ae3-4ee6-a49a-de6566c397e8 41250-247 HUMAN OTC DRUG NiteTime Sinus Acetaminophen, Doxylamine succinate, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20130116 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 41250-248_5309b4c8-8386-4229-8395-bdc5e53a2b6d 41250-248 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140328 OTC MONOGRAPH NOT FINAL part343 MEIJER, INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 41250-253_5a775882-9b73-4a70-9b86-3fcbd2178eba 41250-253 HUMAN OTC DRUG MEIJER MUSCLE ULTRA CAMPHOR, MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20120831 OTC MONOGRAPH NOT FINAL part348 MEIJER, INC. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g N 20181231 41250-254_399678ff-d075-4b2e-a944-704bb70567d3 41250-254 HUMAN OTC DRUG MEIJER COLD AND HOT THERAPY MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part348 MEIJER, INC. MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 41250-255_2b65f746-767d-4a5a-967a-3589455cfa5e 41250-255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20040418 ANDA ANDA075217 Meijer Distribution Inc IBUPROFEN 50 mg/1.25mL N 20181231 41250-256_63560d2b-4ae4-4f37-a106-505068b7e82d 41250-256 HUMAN OTC DRUG MEIJER CAPSAICIN CAPSAICIN CREAM TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part348 MEIJER, INC. CAPSAICIN .1 g/10g N 20181231 41250-263_40304e4d-be04-4c20-a953-202866e5904d 41250-263 HUMAN OTC DRUG Meijer Elements Advanced Firming and Anti-Wrinkle Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g N 20181231 41250-264_a9d50741-6b96-4903-95ae-5e1cbf573514 41250-264 HUMAN OTC DRUG Acne Cleanser Benzoyl peroxide CREAM TOPICAL 20140218 OTC MONOGRAPH FINAL part333D Meijer Distribution, INC BENZOYL PEROXIDE 104 mg/10g N 20181231 41250-266_d7e97974-9c96-4616-bae1-263f925a9253 41250-266 HUMAN OTC DRUG Nighttime Allergy Relief Extra Strength Diphenhydramine HCl TABLET ORAL 20140630 OTC MONOGRAPH FINAL part338 MEIJER, INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 41250-269_4b53a83c-de39-46de-b7bc-ad9c6c6602a3 41250-269 HUMAN OTC DRUG Meijer Medicated Heat Capsaicin PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Meijer CAPSICUM .6 mg/1 N 20181231 41250-272_f299845f-93eb-46fa-8bd3-30392d9dd236 41250-272 HUMAN OTC DRUG sinus congestion and pain daytime Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070117 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 41250-273_0748e196-7975-61b7-e054-00144ff88e88 41250-273 HUMAN OTC DRUG Mucus and Sinus PE ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141107 OTC MONOGRAPH FINAL part341 Meijer ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 41250-274_f03205be-e124-462f-a350-14968a11587c 41250-274 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19961126 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ASPIRIN 81 mg/1 N 20181231 41250-275_34da761f-52e1-2f20-e054-00144ff88e88 41250-275 HUMAN OTC DRUG COLD RELIEF SEVERE HEAD CONGESTION ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141107 OTC MONOGRAPH FINAL part341 Meijer ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 41250-278_71f2f307-d1fa-44a1-8afe-deb67967f33c 41250-278 HUMAN OTC DRUG Pain Relief Adult Extra Strength Acetaminophen LIQUID ORAL 20160229 OTC MONOGRAPH NOT FINAL part343 MEIJER, INC. ACETAMINOPHEN 500 mg/15mL N 20181231 41250-279_fac4ff6c-c5dd-40c6-80a6-6d9640e25b34 41250-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141008 OTC MONOGRAPH FINAL part346 Meijer Distribution Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 41250-280_50187111-e19a-4791-9642-9cb29cb1976b 41250-280 HUMAN OTC DRUG cough and chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20140715 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 41250-281_cb1a91a6-f332-4c46-bcfd-95dc8c1045e3 41250-281 HUMAN OTC DRUG Dandruff Pyrithione zinc 1% SHAMPOO TOPICAL 20020524 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 41250-284_6e8ed233-9ffb-46f7-9632-d5bc3d3a558b 41250-284 HUMAN OTC DRUG Dual Action Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160126 ANDA ANDA077355 Meijer Distribution Inc FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 41250-291_3464da51-c676-4aa3-8270-5a3a5c0b26e7 41250-291 HUMAN OTC DRUG anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid LIQUID ORAL 19960821 UNAPPROVED DRUG OTHER Meijer Distribution Inc DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 41250-294_5a8d5929-1df2-4c3a-aa44-06d8a182f7bf 41250-294 HUMAN OTC DRUG hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20120319 ANDA ANDA091344 Meijer Distribution Inc MINOXIDIL 5 g/100g N 20181231 41250-296_1714bbd1-55d7-4503-89ac-604f32631cfa 41250-296 HUMAN OTC DRUG cough syrup dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 20120725 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 41250-299_20932906-e5bf-4858-ac54-2e5b96c20b37 41250-299 HUMAN OTC DRUG 12 hour allergy d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 19880715 ANDA ANDA077170 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 41250-301_026dbeaa-e796-48fd-a0a0-5f161c3d76fc 41250-301 HUMAN OTC DRUG 12 hour nasal Oxymetazoline Hydrochloride SPRAY NASAL 20150506 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41250-302_ff728a12-e634-457a-863a-6b161a1d184b 41250-302 HUMAN OTC DRUG Eye Itch Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140123 ANDA ANDA077958 Meijer Distribution Inc KETOTIFEN FUMARATE .35 mg/mL N 20181231 41250-303_ce1644fa-e413-4596-91b3-ed4a7f107b7b 41250-303 HUMAN OTC DRUG Itchy Eye Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20160126 ANDA ANDA077958 Meijer Distribution Inc KETOTIFEN FUMARATE .35 mg/mL N 20181231 41250-304_c149ac62-0cdc-43f0-9993-c1a740ae70af 41250-304 HUMAN OTC DRUG nasal 12 hour oxymetazoline hydrochloride SPRAY NASAL 19911206 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41250-305_bc2bed12-f68a-42df-a43c-204939458930 41250-305 HUMAN OTC DRUG meijer Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc CLOTRIMAZOLE 10 mg/g N 20181231 41250-306_0f9088dc-83cb-47e1-a5cb-7195081e760b 41250-306 HUMAN OTC DRUG clear lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091006 ANDA ANDA090685 Meijer Distribution Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 41250-307_9ebc91e8-e046-4561-a579-774a74813ed1 41250-307 HUMAN OTC DRUG Meijer Tolnaftate Tolnaftate CREAM TOPICAL 20150119 OTC MONOGRAPH FINAL part333C Meijer, Inc. TOLNAFTATE 10 mg/g N 20181231 41250-308_aafa26a2-aecb-45a6-9e87-2e0e7044a6b4 41250-308 HUMAN OTC DRUG cold relief severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 19930202 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41250-309_343107f5-e174-4eb6-b97b-cfd69e679dd3 41250-309 HUMAN OTC DRUG Fresh Mint Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20040821 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 1 g/100mL N 20181231 41250-311_79aaf900-2502-4493-a811-724b1af61d9a 41250-311 HUMAN OTC DRUG Everyday Clean Pyrithione Zinc SHAMPOO TOPICAL 20051011 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 1 g/100mL N 20181231 41250-312_155ce739-d3e3-457c-bcfe-1dfe750767fa 41250-312 HUMAN OTC DRUG Quick Wrinkle Repair Moisturizer Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 4; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 41250-313_be85ebb6-9d88-4ee2-b5f3-b5728666e625 41250-313 HUMAN OTC DRUG naproxen sodium Naproxen sodium TABLET, FILM COATED ORAL 20040528 ANDA ANDA074661 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 N 20181231 41250-314_989b09ee-b31d-4f84-9854-fac0c1b6de0a 41250-314 HUMAN OTC DRUG MEIJER MEDICATED WIPES WITCH HAZEL CLOTH TOPICAL 20110601 OTC MONOGRAPH FINAL part346 MEIJER, INC. WITCH HAZEL 5 g/1 N 20181231 41250-315_c5bf8ee9-1d34-49fc-b964-f36be36fe22d 41250-315 HUMAN OTC DRUG MEIJER MEDICATED PADS WITCH HAZEL SOLUTION RECTAL; TOPICAL 20110601 OTC MONOGRAPH FINAL part346 MEIJER, INC. WITCH HAZEL .5 mL/mL N 20181231 41250-318_95ce8711-abdf-47f6-8fc2-94fe09cbcb69 41250-318 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL, menthol, Methyl salicylate, thymol MOUTHWASH ORAL 19900715 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41250-320_35df9d0a-1f4f-5de8-e054-00144ff8d46c 41250-320 HUMAN OTC DRUG Stay Awake CAFFEINE TABLET ORAL 20110801 OTC MONOGRAPH FINAL part340 Meijer CAFFEINE 200 mg/1 N 20181231 41250-321_f03d67db-f31f-4f09-8ee6-a3fd72274653 41250-321 HUMAN OTC DRUG Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080822 ANDA ANDA077355 Meijer Distribution Inc FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 41250-325_4b1f7766-f6f1-495f-aac5-8a4b95ea135a 41250-325 HUMAN OTC DRUG Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160729 ANDA ANDA091009 Meijer Distribution Inc GUAIFENESIN 1200 mg/1 N 20181231 41250-326_44a71a97-24e7-4118-9df6-7057163c3eca 41250-326 HUMAN OTC DRUG Meijer Elements Daily Facial Moisturizer Avobenzone, Octocrylene CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; OCTOCRYLENE 3; 10 g/100mL; g/100mL N 20181231 41250-329_51f8733b-85e7-44ae-af9f-517dc2c456ea 41250-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, FILM COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41250-330_bff8f495-6007-4206-aaf3-7c08a0721b91 41250-330 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20130116 OTC MONOGRAPH FINAL part346 Meijer Distribution Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g N 20181231 41250-332_0efae818-dd19-4577-8113-c8c8c85ff465 41250-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19920826 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 41250-333_740b61e8-1512-4b57-a799-ea0f9b4849dc 41250-333 HUMAN OTC DRUG Enema mineral oil Mineral Oil LIQUID RECTAL 19910808 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MINERAL OIL 100 mL/100mL N 20181231 41250-334_0d7e499a-2476-44fd-a727-d3e0a89db678 41250-334 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin-NSAID, Caffeine TABLET, FILM COATED ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 41250-335_19af8a7f-60ce-463e-8103-3992c514a0cd 41250-335 HUMAN OTC DRUG nitetime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110921 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 41250-336_169808be-511c-48b3-956f-8bf43212d01b 41250-336 HUMAN OTC DRUG Mucus Relief Maximum Strength Multi Symptom Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 MEIJER, INC. DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 650; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 41250-337_ec8b2ac6-829f-4819-b2ee-7b2b60371a9f 41250-337 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20140328 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 41250-338_19d44baf-0ca6-43e7-aaf8-ef1e20b30f1e 41250-338 HUMAN OTC DRUG Meijer Anti Itch Hydrocortisone OINTMENT TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part348 Meijer, Inc. HYDROCORTISONE 1 g/100g N 20181231 41250-340_6c7a3b22-6159-418b-acc7-cd9c0e04ba32 41250-340 HUMAN OTC DRUG antacid aluminum hydroxide, magnesium hydroxide, simethicone SUSPENSION ORAL 19900815 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 41250-341_6792feb0-b900-4a35-9d14-06dd652a7dcf 41250-341 HUMAN OTC DRUG Meijer Ultimate SALICYLIC ACID GEL TOPICAL 20151101 OTC MONOGRAPH FINAL part333D Meijer Distribution Inc SALICYLIC ACID 4 g/200g N 20181231 41250-344_2a359e77-62cd-498a-ae10-b02cc7e85d74 41250-344 HUMAN OTC DRUG nicotine Nicotine Polacrilex LOZENGE ORAL 20060301 ANDA ANDA077007 Meijer Distribution Inc NICOTINE 2 mg/1 N 20181231 41250-345_3e164910-32c6-4ce6-961a-5e5e4f6224fe 41250-345 HUMAN OTC DRUG Meijer Anti Itch Cream Plus Hydrocortisone CREAM TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part348 Meijer, Inc. HYDROCORTISONE 1 g/100g N 20181231 41250-352_f3b7b43c-216d-4b13-9e59-a8387a58125b 41250-352 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070926 ANDA ANDA078547 Meijer Distribution Inc NICOTINE 2 mg/1 N 20181231 41250-357_e303f89d-44ce-45ae-8975-3039515c2cda 41250-357 HUMAN OTC DRUG Meijer Artificial Tears Lubricant Eye Polyvinyl alcohol, and Povidone SOLUTION/ DROPS OPHTHALMIC 20141229 OTC MONOGRAPH FINAL part349 Meijer, Inc. POLYVINYL ALCOHOL; POVIDONE 5; 6 mg/mL; mg/mL N 20181231 41250-360_25f5a29f-8969-4a9e-b6c3-205ac6462049 41250-360 HUMAN OTC DRUG Meijer SPF 8 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20160216 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; OCTOCRYLENE; OXYBENZONE .9; 2; 1.5 g/100g; g/100g; g/100g N 20181231 41250-365_27aef0f5-72fe-40a8-b380-f6504c9f3452 41250-365 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20111214 ANDA ANDA091349 Meijer Distribution Inc NICOTINE 2 mg/1 N 20181231 41250-367_c67f62aa-d717-443e-a33a-05c7ff90fbd7 41250-367 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41250-368_b22ed59d-15c9-4167-9039-b314ac9d1b65 41250-368 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET, FILM COATED ORAL 19970123 ANDA ANDA074661 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 N 20181231 41250-370_5a3a321a-577f-4a14-beda-eadd09f97834 41250-370 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl alcohol GEL TOPICAL 19920424 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc ALCOHOL 616 mg/100mL N 20181231 41250-371_1f5082b7-503a-48a4-8162-bf326a33cbbc 41250-371 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 MEIJER, INC. ASPIRIN 325 mg/1 N 20181231 41250-374_af1bb11b-d1ff-4bca-8977-ea62b76e7263 41250-374 HUMAN OTC DRUG migraine formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20020430 ANDA ANDA075794 Meijer Distribution Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 41250-379_53689c5a-84e6-4f08-825c-fe3a52f671ca 41250-379 HUMAN OTC DRUG allergy childrens Diphenhydramine Hydrochloride SOLUTION ORAL 19871115 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 41250-380_03181999-27ce-4942-8807-b1984608156a 41250-380 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20140519 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 41250-381_484b0361-66c7-4955-88c1-1080c4ecdaf0 41250-381 HUMAN OTC DRUG cold flu and sore throat Acetaminophen, dextromethorphan HBr, Guaifenesin, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20170724 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41250-384_a07c68ca-9546-4929-a17c-acd1c7c336c8 41250-384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120827 ANDA ANDA091135 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 41250-387_e393efac-98c5-4c4f-8543-7a83b9d445b1 41250-387 HUMAN OTC DRUG Meijer Elements Long-Lasting Oil-Free Avobenzone, Octisalate, Octocrylene and Oxybenzone CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 4; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 41250-388_2c53b5c6-7422-4249-a18a-e9a0c13c6973 41250-388 HUMAN OTC DRUG nasal Oxymetazoline HCl SPRAY NASAL 20020911 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41250-389_17dee090-c13b-4913-bc76-d0fe13e48c6a 41250-389 HUMAN OTC DRUG Meijer Family Sport 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20160217 OTC MONOGRAPH NOT FINAL part352 Meijer AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 41250-390_c253ecdc-9354-4965-a818-fb8cf91f24b4 41250-390 HUMAN OTC DRUG Menstrual Complete Maximum Strength Acetaminophen, Caffeine, Pyrilamine maleate TABLET, FILM COATED ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 41250-396_6600e8dc-f6d8-4775-8151-7355ef0465e0 41250-396 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LOTION TOPICAL 20160121 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc ALCOHOL 567 mg/mL N 20181231 41250-398_e20479c6-e376-4130-a78f-187cd6c5251a 41250-398 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20150716 OTC MONOGRAPH FINAL part358B Meijer Distribution Inc SALICYLIC ACID .17 mg/9.8g N 20181231 41250-399_91234982-3a99-447d-b1ea-31de41446751 41250-399 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20150716 OTC MONOGRAPH FINAL part358F Meijer Distribution Inc SALICYLIC ACID .17 g/9mL N 20181231 41250-401_4e849a58-ad34-4d6e-a065-d1e5a1ac8218 41250-401 HUMAN OTC DRUG omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150325 NDA NDA022032 Meijer Distribution Inc OMEPRAZOLE 20 mg/1 N 20181231 41250-404_ebab0f1d-8e32-4937-af63-c025dafdffe1 41250-404 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20060201 OTC MONOGRAPH FINAL part334 Meijer Distribution Inc GLYCERIN 1.3 g/1 E 20171231 41250-407_62959f3b-90d0-4295-a489-beac2fa81ae8 41250-407 HUMAN OTC DRUG Meijer Cold Sore Treatment Camphor CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Meijer BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 41250-408_4cfb507c-dc92-4282-9931-fd9c57510d1a 41250-408 HUMAN OTC DRUG Hydrocortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc HYDROCORTISONE 1 g/100g N 20181231 41250-410_488952c5-1d4e-4e92-b117-338bf301aecd 41250-410 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070320 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution Inc BENZALKONIUM CHLORIDE .13 mL/mL E 20171231 41250-412_a707447f-7ed4-456a-ae72-e4c4aef9d3af 41250-412 HUMAN OTC DRUG Diaper Rash Zinc oxide PASTE TOPICAL 20120510 OTC MONOGRAPH FINAL part347 Meijer Distribution, Inc ZINC OXIDE 532 mg/g N 20181231 41250-413_6ff80e79-afd2-4b05-a5ab-0794bcc5560f 41250-413 HUMAN OTC DRUG ibuprofen pm Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20150423 ANDA ANDA079113 Meijer Distribution Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 41250-416_8e34ab9f-4841-4755-9053-5df928ed4612 41250-416 HUMAN OTC DRUG aspirin regular strength Aspirin TABLET ORAL 19870715 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ASPIRIN 325 mg/1 N 20181231 41250-417_cb78330b-d8a3-4c16-bbb0-d31368a542e6 41250-417 HUMAN OTC DRUG Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130812 ANDA ANDA076518 Meijer Distribution Inc NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 41250-419_6fafe4e7-a918-4873-b5d9-a6bd461d6631 41250-419 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20140423 ANDA ANDA074937 Meijer Distribution Inc IBUPROFEN 100 mg/5mL N 20181231 41250-421_4474e506-df6f-498e-8bc0-a629e1ba738f 41250-421 HUMAN OTC DRUG Meijer Clotrimazole Antifungal Clotrimazole CREAM TOPICAL 20150115 OTC MONOGRAPH FINAL part333C Meijer, Inc. CLOTRIMAZOLE 1 g/100g N 20181231 41250-422_a1f333dc-fe73-4bce-adf0-caa87568e45d 41250-422 HUMAN OTC DRUG nicotine mint flavor Nicotine Polacrilex GUM, CHEWING ORAL 20050124 ANDA ANDA078326 Meijer Distribution Inc NICOTINE 4 mg/1 N 20181231 41250-423_ea96cb21-dc4c-4cca-bb6d-d08e59e08c27 41250-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Meijer Distribution, Inc IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 41250-424_f7faf572-8ebd-4bfe-8222-5c7411245721 41250-424 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20100115 ANDA ANDA090821 Meijer Distribution Inc NICOTINE 4 mg/1 N 20181231 41250-426_e7cb6122-50fa-45bb-951a-445b15d62d40 41250-426 HUMAN OTC DRUG tioconazole 1 Tioconazole OINTMENT VAGINAL 20080109 ANDA ANDA075915 Meijer Distribution Inc TIOCONAZOLE 6.5 g/100g N 20181231 41250-429_fcba46b9-3a41-4580-954b-0acd90dbedbf 41250-429 HUMAN OTC DRUG Lice Treament Piperonyl butoxide, pyrethrum extract KIT 20160921 OTC MONOGRAPH FINAL part358G Meijer Distribution Inc N 20181231 41250-432_8e316a80-28f3-4780-978f-a75f270d968b 41250-432 HUMAN OTC DRUG nasal decongestant maximum strength non drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 19910215 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 41250-433_43486da5-6e8b-45c0-bd7e-cc2d8b28c510 41250-433 HUMAN OTC DRUG triple antibiotic Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20171003 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 41250-434_d336f87f-d2bc-44ea-9aa0-dc69a2afcd81 41250-434 HUMAN OTC DRUG Tartar control Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20140220 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41250-435_e68f5083-0aed-492e-a929-e48d962dfa26 41250-435 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20150909 OTC MONOGRAPH FINAL part355 Meijer Distribution, Inc SODIUM FLUORIDE .2 mg/mL N 20181231 41250-437_a6923623-24a6-4779-9948-0ba3fc062e6f 41250-437 HUMAN OTC DRUG pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19920626 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41250-438_f8b3c850-224d-4474-8f0c-b2b8e21cf723 41250-438 HUMAN OTC DRUG Meijer Oil Free Faces SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part352 Meijer AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 41250-439_a2729559-ac7e-4ad9-aa4f-ab9171d9a068 41250-439 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20131213 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc ALCOHOL 616 mL/mL N 20181231 41250-440_6cea0198-be31-4b02-a42f-09471b2128e3 41250-440 HUMAN OTC DRUG Meijer Oil Free SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20160519 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 41250-441_8e004f5c-6372-433d-b0fe-fb2cfbadfeb5 41250-441 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 19970221 ANDA ANDA040167 Meijer Distribution Inc DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 41250-442_e46d41a6-7d35-4a8a-b89f-86f4d7fa3d9f 41250-442 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20111214 ANDA ANDA091354 Meijer Distribution Inc NICOTINE 4 mg/1 N 20181231 41250-443_f48e5feb-2824-4569-9b0f-2283ab199e77 41250-443 HUMAN OTC DRUG 24 Hour Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20170118 ANDA ANDA078104 Meijer Distribution Inc TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 41250-444_ce55d055-3db2-40f1-b074-1e81f697b616 41250-444 HUMAN OTC DRUG Allergy Relief D Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120410 ANDA ANDA076050 Meijer Distribution Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 41250-447_09d989ab-9c72-47e7-a270-874ace91623b 41250-447 HUMAN OTC DRUG Pain Relief Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050203 20200126 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 80 mg/1 N 20181231 41250-449_c939aa9d-ffb1-4b62-9f5b-77c94b6153a7 41250-449 HUMAN OTC DRUG Pain Relief Junior Strength Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/1 N 20181231 41250-450_49ee86fc-9e4f-4b37-b248-9eacdede2a9a 41250-450 HUMAN OTC DRUG Pain Relief Junior Acetaminophen TABLET, CHEWABLE ORAL 20050225 20200410 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/1 N 20181231 41250-452_c89ebe59-9b63-4d93-a93a-a771f32d002e 41250-452 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20041206 20191201 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 80 mg/1 N 20181231 41250-453_52aa78fd-f29e-494b-9a0b-b8561aac8bf2 41250-453 HUMAN OTC DRUG multi symptom cold dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20140715 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 41250-456_071896f5-0c1d-463f-8666-68e114644d75 41250-456 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061031 ANDA ANDA076777 Meijer Distribution Inc NICOTINE 2 mg/1 N 20181231 41250-458_f1a997e9-66d3-4c8c-b7cd-954a1ef4d5f7 41250-458 HUMAN OTC DRUG 24 hour allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 19970707 ANDA ANDA078336 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 41250-459_6db4d6c4-bb86-436f-be84-a3f6a2995ddf 41250-459 HUMAN OTC DRUG nitetime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110909 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 41250-460_d2a6fdbb-2638-4e6d-92b3-59bb5dd9a3e2 41250-460 HUMAN OTC DRUG severe sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20140627 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 41250-461_75c820b8-88ce-41e0-ab2f-eb7f3b19bc04 41250-461 HUMAN OTC DRUG ibuprofen junior strength Ibuprofen TABLET, CHEWABLE ORAL 20040502 ANDA ANDA076359 Meijer Distribution Inc IBUPROFEN 100 mg/1 N 20181231 41250-463_2a3e72cf-f9db-48b2-a16a-a6c2f62dc05c 41250-463 HUMAN OTC DRUG Salicylic acid Medicated Callus Removers Extra Thick PATCH TOPICAL 20170101 OTC MONOGRAPH FINAL part358F Meijer Distribution Inc SALICYLIC ACID 40 mg/41 N 20181231 41250-464_23b8e594-9d1d-4ccd-a435-37b98b128c38 41250-464 HUMAN OTC DRUG Allergy Plus Sinus Headache Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET, FILM COATED ORAL 20050615 20200619 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 41250-465_0dc9e8fc-5879-459c-8b62-c399d312e9c0 41250-465 HUMAN OTC DRUG Cold and Sinus PE Pressure, Pain and Cold Non-Drowsy Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20070222 20200329 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41250-467_2d41e070-b9b9-4688-ae79-f7838dd5b630 41250-467 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19920827 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ASPIRIN 81 mg/1 N 20181231 41250-468_f943486a-e4cd-4c87-9464-85212e3e329a 41250-468 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 19961126 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 750 mg/1 N 20181231 41250-471_63a95088-9641-40a4-9b65-3c40159644d4 41250-471 HUMAN OTC DRUG Night Time Cold and Flu Relief Multi Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part341 MEIJER, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 41250-472_2829f2e8-984c-4af0-a168-e911d811445b 41250-472 HUMAN OTC DRUG Wonderblur Immediate Skin Smoothing Finishing Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 41250-473_95bf9585-7937-4fee-a023-770d6ad1c69b 41250-473 HUMAN OTC DRUG daytime cough non drowsy Dextromethorphan HBr SOLUTION ORAL 20070815 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL N 20181231 41250-475_6a5549b3-e0a9-40e1-b80d-b81b2f1932c9 41250-475 HUMAN OTC DRUG Childrens 24 Hour Allergy Cetirizine HCl SOLUTION ORAL 20151202 ANDA ANDA204226 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 41250-477_40f83e8b-bd97-4c65-8c03-de467a4bcc64 41250-477 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20140305 ANDA ANDA074661 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 N 20181231 41250-478_78d08861-7dfe-4aac-8760-58194eef97c5 41250-478 HUMAN OTC DRUG antacid calcium carbonate TABLET, CHEWABLE ORAL 19940503 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 500 mg/1 N 20181231 41250-479_0a4dc253-270d-4492-8836-a858ab7033dd 41250-479 HUMAN OTC DRUG allergy Diphenhydramine Hydrochloride TABLET ORAL 19910906 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41250-480_ebf45dc0-c44f-47a3-a56a-0f737562a642 41250-480 HUMAN OTC DRUG NiteTime Cold Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20141030 OTC MONOGRAPH FINAL part341 MEIJER, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 41250-481_d91e23f3-b37a-4df6-95fc-1402f6f260a0 41250-481 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 20151031 OTC MONOGRAPH FINAL part341 MEIJER, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41250-482_efe59d75-be25-42ce-84ce-348d476e983e 41250-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20120222 OTC MONOGRAPH FINAL part355 Meijer Distribution, Inc SODIUM FLUORIDE .1 mg/mL N 20181231 41250-484_d79756a8-0b01-437a-b6cc-6d1ee4638eb2 41250-484 HUMAN OTC DRUG pain relief Acetaminophen TABLET ORAL 19870815 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 N 20181231 41250-485_3aff8952-5d31-41f4-81f0-14e43b4ce7db 41250-485 HUMAN OTC DRUG antacid calcium carbonate TABLET, CHEWABLE ORAL 19940503 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 500 mg/1 N 20181231 41250-486_ed0b0e9a-67dd-4745-9a5c-4f0033f8b337 41250-486 HUMAN OTC DRUG stool softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20150121 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc DOCUSATE SODIUM 100 mg/1 N 20181231 41250-487_712376e0-065f-474d-a771-85a895df4469 41250-487 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part347 MEIJER, INC. DIMETHICONE 125 mg/1 N 20181231 41250-489_d4008b1d-982d-4a34-b46e-ed46e3626aa2 41250-489 HUMAN OTC DRUG antacid Calcium carbonate TABLET, CHEWABLE ORAL 20000720 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 750 mg/1 N 20181231 41250-490_498a1899-3e3d-4c5e-b08f-297802e29ff1 41250-490 HUMAN OTC DRUG ALL DAY RELIEF Naproxen Sodium TABLET ORAL 19970529 ANDA ANDA074661 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 N 20181231 41250-491_a0f5a0d2-4abb-4040-bc46-8e74ae60c2be 41250-491 HUMAN OTC DRUG meijer Miconazole 3 Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Meijer Distribution Inc MICONAZOLE NITRATE 40 mg/g N 20181231 41250-492_d82d43d7-713e-464a-acf8-3adaae905d24 41250-492 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20160331 OTC MONOGRAPH NOT FINAL part334 MEIJER, INC. SENNOSIDES 25 mg/1 N 20181231 41250-494_6bdfa599-7898-4c05-927c-52fb82e0e686 41250-494 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150326 ANDA ANDA091135 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 41250-497_91278f01-e223-439d-bab9-34396b4d7b3e 41250-497 HUMAN OTC DRUG Jock Itch Relief Miconazole Nitrate SPRAY TOPICAL 20170329 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc MICONAZOLE NITRATE 2 g/100g N 20181231 41250-498_ec97cee3-54c2-4f1d-8fd1-fbe14487592f 41250-498 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130318 ANDA ANDA078912 Meijer Distribution Inc GUAIFENESIN 600 mg/1 N 20181231 41250-499_8e23d7a9-0fb5-4f92-aef5-9c641cb49486 41250-499 HUMAN OTC DRUG meijer antifungal Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc TOLNAFTATE 10 mg/g N 20181231 41250-500_26e3b5b8-6806-4176-9f3b-b8bf2bed9b6b 41250-500 HUMAN OTC DRUG meijer Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 41250-501_35df9bc2-05ce-5cee-e054-00144ff8d46c 41250-501 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen TABLET ORAL 20120301 OTC MONOGRAPH NOT FINAL part343 Meijer ACETAMINOPHEN 325 mg/1 N 20181231 41250-502_7d5e405b-c1cb-415b-869d-e3412581708d 41250-502 HUMAN OTC DRUG Nausea Relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20141030 UNAPPROVED DRUG OTHER Meijer Distribution Inc DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 41250-504_5dec4a51-9b97-4141-b195-14799fb6293b 41250-504 HUMAN OTC DRUG meijer Triple Antibiotic plus Pain Relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 41250-505_f6763293-72fc-47df-82bf-805db5759cce 41250-505 HUMAN OTC DRUG meijer Antibiotic Plus Pain Relief Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 41250-507_43fb0dcd-ea9a-492b-b880-646992deeeda 41250-507 HUMAN OTC DRUG mucus and chest congestion Guaifenesin SOLUTION ORAL 20140715 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc GUAIFENESIN 200 mg/10mL N 20181231 41250-510_9a1c3e96-9a12-448b-a732-e4eb277327f7 41250-510 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170208 ANDA ANDA206393 Meijer Distribution Inc NICOTINE 4 mg/1 N 20181231 41250-511_b21153cf-355a-488d-86cd-d96cae631923 41250-511 HUMAN OTC DRUG Cough and Sinus PE Pressure, Pain and Cough Non-Drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20140731 20200329 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41250-512_5455f4f1-2fab-493f-befa-674cde3ef214 41250-512 HUMAN OTC DRUG Meijer Glisten White Fluoride PASTE, DENTIFRICE DENTAL 20140224 OTC MONOGRAPH FINAL part355 Meijer SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 41250-513_f9612ddf-5bbc-4756-a195-4fd5547e7bee 41250-513 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Meijer Distribution, Inc. LORATADINE 10 mg/1 N 20181231 41250-515_3c60e505-89ca-4499-a802-c1c1d07b63ce 41250-515 HUMAN OTC DRUG daytime nitetime sinus Acetaminophen, Doxylamine succinate , Phenylephrine HCl KIT 20070810 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc N 20181231 41250-519_0a9bfa0f-4095-4288-8a76-675249126c7b 41250-519 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 N 20181231 41250-520_3ad7e731-b7ac-49e1-947b-316b2f8e224b 41250-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20160831 NDA NDA021855 MEIJER, INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 41250-521_74bd0237-f93d-411b-8bc2-874837df6721 41250-521 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET ORAL 20090527 ANDA ANDA076359 Meijer Distribution Inc IBUPROFEN 100 mg/1 N 20181231 41250-523_2079e4bb-4d88-45a1-97c5-df4f1b6b9e0c 41250-523 HUMAN OTC DRUG allergy relief Loratadine TABLET ORAL 20170712 ANDA ANDA076301 Meijer Distribution Inc LORATADINE 10 mg/1 N 20181231 41250-527_f9612ddf-5bbc-4756-a195-4fd5547e7bee 41250-527 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Meijer Distribution, Inc. LORATADINE 10 mg/1 N 20181231 41250-528_6214ade3-0be5-4516-afcd-12e49a5e4f5e 41250-528 HUMAN OTC DRUG Antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 19951113 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 750 mg/1 N 20181231 41250-532_0fb68959-f78d-4896-b00e-44f539962d81 41250-532 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061031 ANDA ANDA076779 Meijer Distribution Inc NICOTINE 4 mg/1 N 20181231 41250-533_5ab0904c-8045-4f0e-8caa-9de1132882a1 41250-533 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr and Guaifenesin TABLET, FILM COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 41250-536_4f0beb54-3b13-49d1-93fc-c856f93298f9 41250-536 HUMAN OTC DRUG antibiotic Bacitracin OINTMENT TOPICAL 20150415 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc BACITRACIN 500 [USP'U]/g N 20181231 41250-538_66f3de7d-d24e-49f7-b392-6311a9e9336d 41250-538 HUMAN OTC DRUG Morning Fresh Hand Sanitizer Ethyl alcohol GEL TOPICAL 20160121 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc ALCOHOL 558 mg/mL N 20181231 41250-541_93ba57d1-8a90-41d0-b46e-b5e481f3d738 41250-541 HUMAN OTC DRUG allergy relief Diphenhydramine Hydrochloride TABLET ORAL 20170712 OTC MONOGRAPH FINAL part341 Meijer, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41250-543_befd27cb-618e-440e-a3cf-f3c5522b6b80 41250-543 HUMAN OTC DRUG Severe Allergy Plus Sinus Headache Maximum Strength Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET, COATED ORAL 20070627 20200606 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 41250-544_8b0f75a3-7e8d-4fa4-bb5e-a809886947ea 41250-544 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050326 ANDA ANDA075077 Meijer Distribution Inc ACETAMINOPHEN 650 mg/1 N 20181231 41250-546_063accc6-3cae-4b0b-9bdc-40de94a585ce 41250-546 HUMAN OTC DRUG complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080822 ANDA ANDA077355 Meijer Distribution Inc FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 41250-547_f1137f4e-c6e3-4c9f-9eca-ec9398bf5495 41250-547 HUMAN OTC DRUG Mucus Relief D Guaifenesin, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20070126 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 400; 40 mg/1; mg/1 N 20181231 41250-548_453f530a-0538-42f5-af93-041bbaba5237 41250-548 HUMAN OTC DRUG daytime cold and flu acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20131230 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41250-551_2c4ed4dc-7999-4a15-a6f9-21e9f267ab4b 41250-551 HUMAN OTC DRUG Medicated Body Powder MENTHOL POWDER TOPICAL 20090505 OTC MONOGRAPH FINAL part348 Meijer Distribution, Inc MENTHOL; ZINC OXIDE .15; 1 kg/100kg; kg/100kg N 20181231 41250-554_ddfa19e1-5f76-48ba-9f03-a4d39185d231 41250-554 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140228 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL N 20181231 41250-556_14c9e1d7-2d88-4ebb-851e-c16dacb190d1 41250-556 HUMAN OTC DRUG Rapid Release Pain Relief PM Acetaminophen and Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41250-558_35dfc6fb-30e7-6611-e054-00144ff8d46c 41250-558 HUMAN OTC DRUG Cold and Allergy CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110801 OTC MONOGRAPH FINAL part341 Meijer CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 41250-565_42c2f2cc-f0a3-4f56-9b95-9354a1c62a2f 41250-565 HUMAN OTC DRUG Day Time Sinus Acetaminophen, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20121221 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 41250-568_82eebcf1-31d2-43b9-978a-25ba7361a66c 41250-568 HUMAN OTC DRUG DayTime Cold and Flu Non Drowsy ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part341 MEIJER, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41250-572_9df0135a-a57b-4fc0-94a5-188b72c6c78d 41250-572 HUMAN OTC DRUG Tension Headache Acetaminophen, Caffeine TABLET ORAL 20090209 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 41250-575_7a84419c-340a-4b41-9966-f1d488c05168 41250-575 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Powder Miconazole Nitrate Talc Free POWDER TOPICAL 20171201 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc MICONAZOLE NITRATE 1.42 g/71g N 20181231 41250-576_1cba6771-cc42-4b86-98f8-c1d5498d7f1c 41250-576 HUMAN OTC DRUG Oral Antivavity Sodium fluoride MOUTHWASH ORAL 20150206 OTC MONOGRAPH FINAL part355 Meijer Distribution, Inc SODIUM FLUORIDE 10.41 mg/mL N 20181231 41250-580_3264b14b-c34c-46cc-a4fe-a5d4d98d0a6d 41250-580 HUMAN OTC DRUG DayTime NiteTime Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140625 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc N 20181231 41250-581_d31f0f32-932e-45ba-96fd-82fd9d825d0f 41250-581 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20161018 OTC MONOGRAPH FINAL part355 Meijer Distribution, Inc SODIUM FLUORIDE .2 mg/mL N 20181231 41250-582_145140de-dcc1-45a2-b972-618e37acdd21 41250-582 HUMAN OTC DRUG Meijer Lubricant Single Vial Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20150203 OTC MONOGRAPH FINAL part349 Meijer, Inc. CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL N 20181231 41250-583_0129368a-5e13-4c7d-a2b8-a7e1c6aa8f52 41250-583 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Meijer Distribution Inc LORATADINE 5 mg/5mL N 20181231 41250-588_0c00423c-66b1-4f2a-a002-d6f224fb5351 41250-588 HUMAN OTC DRUG Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone SUSPENSION ORAL 20051019 OTC MONOGRAPH FINAL part332 Meijer Distribution Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 41250-589_9af2685d-67cb-4865-b70c-033db28004dc 41250-589 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20140610 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution Inc BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 41250-590_6e6a154e-5d32-474a-9bc9-fa57486af7e6 41250-590 HUMAN OTC DRUG pain and fever acetaminophen SUSPENSION ORAL 19930723 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL N 20181231 41250-595_55eb85c5-0e78-470d-8f0c-2abaddb45c37 41250-595 HUMAN OTC DRUG antacid Calcium Carbonate TABLET, CHEWABLE ORAL 19950317 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 1000 mg/1 N 20181231 41250-596_af7ce0a0-0cdf-4848-96a9-d1e52d5787a0 41250-596 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 41250-597_8ad2026c-dc7d-4bc5-8b02-18b28d2720e4 41250-597 HUMAN OTC DRUG NiteTime DayTime Cold and Flu acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20131230 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc N 20181231 41250-599_e2f9d557-c11b-4a3c-a17c-5a8fe19d7d44 41250-599 HUMAN OTC DRUG Allergy Relief Childrens Diphenhydramine HCl TABLET, CHEWABLE ORAL 20110425 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20181231 41250-600_ea8a1b23-91c8-420b-8d74-e722f866cdb2 41250-600 HUMAN OTC DRUG Aspirin 81 mg Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ASPIRIN 81 mg/1 N 20181231 41250-601_8864fbd4-f80e-49d4-8e34-cc29db5d4d80 41250-601 HUMAN OTC DRUG daytime nitetime cold and flu Acetaminophen, dextromethorphan HBr, Doxylamine Succinate, Guaifenesin, Phenylephrine HCl KIT 20150723 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc N 20181231 41250-601_ec548252-40e8-4d6b-9bb4-b6941e663fff 41250-601 HUMAN OTC DRUG Meijer Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20150115 UNAPPROVED DRUG OTHER Meijer Distribution Inc. PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 41250-602_41267d92-0c81-4894-87eb-55a6c4d7b16c 41250-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20130426 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution, Inc MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 41250-603_c338f884-2dbb-4337-97a9-1765690316a6 41250-603 HUMAN OTC DRUG Daytime Cold and Flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20131211 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 41250-604_37f72f2b-0c34-4397-900a-141e2ca52418 41250-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET ORAL 19880215 ANDA ANDA072096 Meijer Distribution Inc IBUPROFEN 200 mg/1 N 20181231 41250-605_660f1bb3-d6ea-4af3-a6f3-7d007a8f538e 41250-605 HUMAN OTC DRUG multi symptom cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20140715 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 41250-606_a90854a9-1d3a-4d42-a071-5f0a87539492 41250-606 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160311 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc. ALCOHOL 567 mg/mL N 20181231 41250-607_edd3ae39-9f29-4a26-87d8-215436c243f9 41250-607 HUMAN OTC DRUG Crisp Apple Hand Sani Ethyl Alcohol LIQUID TOPICAL 20160311 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc ALCOHOL 585 g/mL N 20181231 41250-611_6bee8d30-1d53-4b4b-8ae6-96ea8e59d8ac 41250-611 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20170731 ANDA ANDA074661 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 N 20181231 41250-612_78f33e15-9c1a-4a68-86ab-562308993d5b 41250-612 HUMAN OTC DRUG allergy relief Loratadine TABLET ORAL 20070418 ANDA ANDA076301 Meijer Distribution Inc LORATADINE 10 mg/1 N 20181231 41250-613_fb6ae4bf-52f7-47fb-a703-236a9d17e958 41250-613 HUMAN OTC DRUG pain relief Acetaminophen TABLET ORAL 20170712 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 N 20181231 41250-616_2fb0640f-78c0-47a8-9d3a-632cd9af31d2 41250-616 HUMAN OTC DRUG Mucus Relief Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 20200329 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41250-617_345c2fdd-fcb2-4d34-bd10-0038443ff3a3 41250-617 HUMAN OTC DRUG Meijer Ultra Lubricant Eye Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20141229 OTC MONOGRAPH FINAL part349 Meijer, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 41250-619_96ec1439-dbe3-406a-b68e-7035c99ffd0e 41250-619 HUMAN OTC DRUG Daily Moisturizing Daily moisturizing LOTION TOPICAL 20060519 OTC MONOGRAPH FINAL part347 Meijer DIMETHICONE 1.3 kg/100kg N 20181231 41250-620_ddeee52d-19af-4f33-991e-468aa1e39753 41250-620 HUMAN OTC DRUG Motion Sickness Less Drowsy Formula Meclizine HCl TABLET ORAL 20140328 OTC MONOGRAPH FINAL part336 MEIJER, INC. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 41250-621_bda09705-43fa-418c-8fca-1f6f36c31461 41250-621 HUMAN OTC DRUG Glistening Pear Hand Sainitizer Hand Sanitizer GEL TOPICAL 20160221 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc. ALCOHOL 62 mg/mL N 20181231 41250-622_f2590632-efff-4a7c-894f-10a0e27f8b67 41250-622 HUMAN OTC DRUG Anti Itch Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20100317 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 41250-626_c3e85e60-6898-4be9-a135-05f5b197d465 41250-626 HUMAN OTC DRUG childrens ibuprofen Ibuprofen SUSPENSION ORAL 20170712 ANDA ANDA074937 Meijer Distribution Inc IBUPROFEN 100 mg/5mL N 20181231 41250-630_7c71be16-fcf4-4a5b-ae11-209d19480fe4 41250-630 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 20140328 OTC MONOGRAPH FINAL part336 MEIJER, INC. DIMENHYDRINATE 50 mg/1 N 20181231 41250-631_c9ac8f43-8056-48e0-9455-df1bf6e5cf47 41250-631 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19980505 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL N 20181231 41250-634_b69241d8-f019-43fe-b12b-25edcf01df40 41250-634 HUMAN OTC DRUG Allergy Relief Fluticasone propionate SPRAY, METERED NASAL 20160527 ANDA ANDA207957 Meijer Distribution Inc FLUTICASONE PROPIONATE 50 ug/1 N 20181231 41250-635_f9f2c136-71c1-40a2-8293-eed31d312523 41250-635 HUMAN OTC DRUG Tolnaftate Foot Odor Control Powder Spray AEROSOL, SPRAY TOPICAL 20120105 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc TOLNAFTATE 1.3 g/113g N 20181231 41250-641_f99dc4d3-1069-43b2-8c36-7bde54722a64 41250-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140602 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 41250-645_f05b6b95-2bae-454b-b4cf-cc96b2940879 41250-645 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120511 ANDA ANDA091292 Meijer Distribution Inc LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 41250-647_4ceb64c6-c685-4679-b506-9af1c1da40d5 41250-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 19881115 ANDA ANDA072096 Meijer Distribution Inc IBUPROFEN 200 mg/1 N 20181231 41250-648_f945e131-f07d-4e15-890b-6035534b8170 41250-648 HUMAN OTC DRUG Nasal Four Phenylephrine hydrochloride SPRAY NASAL 20030303 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 41250-650_73c787c0-b8a9-4b51-a7b8-b0cbcdae80bb 41250-650 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20131218 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL N 20181231 41250-651_fded3211-8630-496b-8b3a-0c0cce2d2a04 41250-651 HUMAN OTC DRUG Mucus Relief Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130630 20200330 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 41250-652_e5c1f927-5bf8-44e3-828c-15a17656342c 41250-652 HUMAN OTC DRUG Day Severe Cold Night Cold and Flu Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, doxylamine succinate KIT 20170724 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc N 20181231 41250-656_444d1283-91b1-4e85-819a-9e8da2c7d1ed 41250-656 HUMAN OTC DRUG Daytime cold and flu non drowsy acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 19890915 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 41250-657_50d87cef-5afc-44ae-8fa5-2d03bb38e0f9 41250-657 HUMAN OTC DRUG gas relief ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20020509 OTC MONOGRAPH FINAL part332 Meijer Distribution Inc DIMETHICONE 180 mg/1 N 20181231 41250-660_8d95ad13-9224-4bfd-812a-96b7facb78c9 41250-660 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020319 ANDA ANDA074937 Meijer Distribution Inc IBUPROFEN 100 mg/5mL N 20181231 41250-663_34da761f-52cb-2f20-e054-00144ff88e88 41250-663 HUMAN OTC DRUG Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141107 OTC MONOGRAPH FINAL part341 Meijer ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41250-664_87a8288f-f20d-4722-a688-6b9c9a8a0c7b 41250-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19930811 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41250-666_e7f83c77-cb85-40b6-8498-60fb4980f8c6 41250-666 HUMAN OTC DRUG cough and sore throat multi symptom Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20051005 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 41250-667_6de053e4-81fe-4298-95ba-9a670c7671f3 41250-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 19890815 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 41250-668_e4b0270a-13bc-471b-811b-f7f1c77d7a8f 41250-668 HUMAN OTC DRUG Nitetime Cough Dextromethorphan Hydrobromide, Doxylamine Succinate SOLUTION ORAL 20030303 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 41250-673_e4c78105-8d9f-4bd9-b8f0-ec84e6429c41 41250-673 HUMAN OTC DRUG Headache Relief Mild Acetaminophen, Caffeine TABLET ORAL 20150301 20190302 OTC MONOGRAPH NOT FINAL part343 Meijer ACETAMINOPHEN; CAFFEINE 325; 65 mg/1; mg/1 E 20171231 41250-677_6c4bd898-b6d5-4ec3-8862-eb4af1aa8bc0 41250-677 HUMAN OTC DRUG Iodine Topical Solution povidone-iodine SOLUTION TOPICAL 20041202 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution Inc POVIDONE-IODINE .1 mg/mL E 20171231 41250-680_a0579dee-9f90-427a-9d97-a29ffc0b5020 41250-680 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140305 ANDA ANDA074661 Meijer Distribution Inc NAPROXEN SODIUM 220 mg/1 N 20181231 41250-685_e5d8f43c-c2e2-499b-a026-4f8aab5d99f0 41250-685 HUMAN OTC DRUG childrens ibuprofen Ibuprofen SUSPENSION ORAL 19941121 ANDA ANDA074937 Meijer Distribution Inc IBUPROFEN 100 mg/5mL N 20181231 41250-688_73239c45-f2a1-4e7b-9470-d0873248d31c 41250-688 HUMAN OTC DRUG Sinus relief Oxymetazoline HCl SPRAY NASAL 20030813 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL N 20181231 41250-690_50fe57e1-6678-4697-9b35-4673db67d4fb 41250-690 HUMAN OTC DRUG Dual Action Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20160126 ANDA ANDA077355 Meijer Distribution Inc FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 41250-693_6cec8e74-e137-4163-b881-995b4f64811e 41250-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19930913 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 41250-695_d3cb7342-9bc5-429d-adce-ed7cc557d6ed 41250-695 HUMAN OTC DRUG jock itch relief Tolnaftate SPRAY TOPICAL 20170329 OTC MONOGRAPH FINAL part333C Meijer Distribution Inc TOLNAFTATE 1 g/100g N 20181231 41250-697_25b4bf44-e73c-4df2-a2bf-e55763036e9a 41250-697 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc. ALCOHOL 558 mg/mL N 20181231 41250-700_8eb006ad-ec42-4373-aecb-36f3cf3562fa 41250-700 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20090911 ANDA ANDA090711 Meijer Distribution Inc NICOTINE 2 mg/1 N 20181231 41250-701_51e14b50-af28-4132-873a-37e904549c1d 41250-701 HUMAN OTC DRUG Oral Analgesic Maximum Strength Oral Pain Reliever GEL TOPICAL 20100513 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution, Inc. BENZOCAINE 200 mg/g N 20181231 41250-702_1221c7bc-1ea8-4869-b857-70c1bc7f70b0 41250-702 HUMAN OTC DRUG No Touch Chest Rub Camphor - 4.80% Eucalyptus Oil - 1.20% Menthol - 2.60% STICK TOPICAL 20160601 OTC MONOGRAPH FINAL part341 Meijer CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g N 20181231 41250-703_bd867d71-24cc-47ea-b64a-5c9200ce5a6d 41250-703 HUMAN OTC DRUG Oral Analgesic Maximum Strength Benzocaine LIQUID TOPICAL 20100513 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution Inc. BENZOCAINE .2 mL/mL N 20181231 41250-704_de56d99b-2d91-4d59-829b-f6030ec78fc9 41250-704 HUMAN OTC DRUG cough and chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20140715 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 41250-705_33740434-87f8-4b89-b984-4610c428f359 41250-705 HUMAN OTC DRUG Meijer Baby Tear Free SPF 50 Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Meijer Distributing Inc. TITANIUM DIOXIDE; ZINC OXIDE 3.2; 4 g/100g; g/100g N 20181231 41250-706_69f354c4-fa32-48e6-95e6-8a754e8bdbd0 41250-706 HUMAN OTC DRUG Oral Analgesic Maximum Strength Benzocaine and Menthol PASTE TOPICAL 20100513 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution Inc. BENZOCAINE; MENTHOL 200; 2.5 mg/g; mg/g N 20181231 41250-707_c2ec20e7-0b89-408e-b78f-459c0c80ac02 41250-707 HUMAN OTC DRUG Meijer Sheer SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 8; 5; 4; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 41250-717_bddae624-9c4d-47c8-8bd1-a3dd4eea28cd 41250-717 HUMAN OTC DRUG Mucus Relief Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET ORAL 20130407 20200929 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41250-719_66638804-5311-42e7-a051-af6c1a63b781 41250-719 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20170823 OTC MONOGRAPH FINAL part333B Meijer Distribution Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 41250-721_f1941bcb-cfa8-4a1d-b883-1a71f6173008 41250-721 HUMAN OTC DRUG allergy relief Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20170712 ANDA ANDA078336 Meijer, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 41250-722_195e7d7d-b753-4552-b00f-7e919af9266b 41250-722 HUMAN OTC DRUG 24 hour allergy relief Loratadine TABLET ORAL 20141230 ANDA ANDA076301 Meijer Distribution Inc LORATADINE 10 mg/1 N 20181231 41250-724_e3e15a0b-407e-4c30-9600-e79d4313fbb4 41250-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Meijer Distribution, Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 41250-725_2efc9fce-7bfa-4a9b-9fb4-f68bd8cff201 41250-725 HUMAN OTC DRUG Childrens Allergy Fexofenadine Hydrochloride Fexofenadine Hydrochloride SUSPENSION ORAL 20141219 ANDA ANDA203330 Meijer Distribution Inc FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 41250-730_a6430b07-9408-49e1-8e98-781afe2ea8c1 41250-730 HUMAN OTC DRUG childrens allergy Diphenhydramine HCl SOLUTION ORAL 20170712 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 41250-733_e5341956-333e-4da7-aa83-aa1c13b0fa0f 41250-733 HUMAN OTC DRUG daytime nitetime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20121024 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc N 20181231 41250-734_0363cf3f-bb25-4a9c-9005-2ea7e2cadd29 41250-734 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130118 ANDA ANDA203690 Meijer Distribution Inc NICOTINE 2 mg/1 N 20181231 41250-735_d58caf3a-5d37-4983-99ee-fff4146087e6 41250-735 HUMAN OTC DRUG Mucus DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160729 ANDA ANDA091070 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 41250-737_41dd6b55-a72b-45af-b28f-10ea266b69dc 41250-737 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100609 ANDA ANDA079114 Meijer Distribution Inc N 20181231 41250-740_deeb696f-3441-46ae-83c9-caa176af34b4 41250-740 HUMAN OTC DRUG Meijer Elements 7-in-1 Anti-Aging Vitamin Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mL/100mL; mL/100mL; mL/100mL N 20181231 41250-747_10efab16-40b7-4259-b330-b31156057aa3 41250-747 HUMAN OTC DRUG Aloe Vera Gel Lidocaine HCl, Menthol GEL TOPICAL 20160829 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution LIDOCAINE HYDROCHLORIDE; MENTHOL 4.97; .4 mg/mL; mg/mL N 20181231 41250-750_b6ee4c6d-bd5b-4002-8c32-a67582a308fb 41250-750 HUMAN OTC DRUG Sore Mouth Cleanser Hydrogen Peroxide MOUTHWASH TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part333A Meijer HYDROGEN PEROXIDE 1588 mg/mL N 20191231 41250-751_a6ca3579-d0c1-4d82-a135-b8ae94b72983 41250-751 HUMAN OTC DRUG pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120222 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41250-760_9542d2cc-ef19-4bb9-92e1-aa05f8e49c6b 41250-760 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20150731 OTC MONOGRAPH NOT FINAL part334 MEIJER, INC. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 41250-763_f70b666f-8a68-4673-b30e-19ddff1ff662 41250-763 HUMAN OTC DRUG Nitetime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20131211 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 41250-766_8a8f3469-ceb2-412e-9f52-16ff654d7718 41250-766 HUMAN OTC DRUG pain and fever Acetaminophen SUSPENSION ORAL 20111104 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL N 20181231 41250-770_b18863f3-c87f-4583-97f5-4c824a9000bb 41250-770 HUMAN OTC DRUG Lubricant Eye Polyethylene glycol, Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20130605 OTC MONOGRAPH FINAL part349 Meijer Distribution Inc POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL N 20181231 41250-772_bfc8ee74-34aa-42cc-a914-6cac5a8e29d7 41250-772 HUMAN OTC DRUG Daytime Nighttime Cold and Flu Relief Multi-Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20160331 OTC MONOGRAPH FINAL part341 MEIJER, INC. N 20181231 41250-775_09325e0d-82f4-4914-a366-ec1cd407ce90 41250-775 HUMAN OTC DRUG Deep Cleaning Astringent Salicylic Acid LIQUID TOPICAL 20130601 OTC MONOGRAPH FINAL part333D Meijer Distribution SALICYLIC ACID 5 mg/mL N 20181231 41250-777_dcf6702b-76df-4ff2-b2b5-2522f70be76a 41250-777 HUMAN OTC DRUG Sport Sunscreen SPF 15 Meijer Avobenzone 2% Homosalate 10% Octisalate 5% Oxybenzone 3% SPRAY TOPICAL 20120802 OTC MONOGRAPH NOT FINAL part352 Meijer AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2; 10; 5; 3 g/100g; g/100g; g/100g; g/100g N 20181231 41250-778_6729644c-ac01-4e6a-b9a0-3d648a4a1ad7 41250-778 HUMAN OTC DRUG Stool Softener Laxative Docusate sodium CAPSULE, LIQUID FILLED ORAL 20171001 OTC MONOGRAPH NOT FINAL part334 MEIJER, INC. DOCUSATE SODIUM 100 mg/1 N 20181231 41250-780_34da761f-528b-2f20-e054-00144ff88e88 41250-780 HUMAN OTC DRUG Aspirin 81 mg ASPIRIN TABLET, DELAYED RELEASE ORAL 20110401 OTC MONOGRAPH NOT FINAL part343 Meijer ASPIRIN 81 mg/1 N 20181231 41250-782_611508fa-29c3-435d-b8c4-b2c4bfb0ae8e 41250-782 HUMAN OTC DRUG Meijer Maximum Strength Oral Pain Relief Benzocaine, and Benzalkonium Chloride GEL TOPICAL 20161208 OTC MONOGRAPH NOT FINAL part356 MEIJER DISTRIBUTION INC BENZOCAINE; BENZALKONIUM CHLORIDE 200; 1 mg/g; mg/g N 20181231 41250-784_a7506f46-bff9-fa95-be1e-12f70eb31b1a 41250-784 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine hydrochloride TABLET ORAL 20141229 ANDA ANDA076502 Meijer Distribution, Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 41250-785_5d2874f3-dc5a-43c8-8283-e565a6ac164e 41250-785 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 MEIJER, INC. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 41250-791_69be15dc-e434-45e4-b68c-5f7d2bc92b43 41250-791 HUMAN OTC DRUG Meijer Lubricant Dry Eye Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20150105 OTC MONOGRAPH FINAL part349 Meijer, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 41250-792_ec367e19-b873-4e0b-827d-9068db9c8eb1 41250-792 HUMAN OTC DRUG Meijer Lubricating Eye Carboxymethylcellulose sodium, and Glycerin SOLUTION/ DROPS OPHTHALMIC 20150120 OTC MONOGRAPH FINAL part349 Meijer, Inc. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 41250-796_682512d7-1458-48d9-813e-cd07f74e23e1 41250-796 HUMAN OTC DRUG Meijer Zinc SPF 50 Octocrylene, Zinc Oxide LOTION TOPICAL 20160310 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution, Inc. OCTOCRYLENE; ZINC OXIDE 4; 5 g/100g; g/100g N 20181231 41250-798_bc69ab39-748e-4a49-8e6a-479afe631f84 41250-798 HUMAN OTC DRUG Hair Regrowth Treatment Extra Strength for Men Minoxidil SOLUTION TOPICAL 20091229 ANDA ANDA075598 Meijer Distribution Inc MINOXIDIL 3 g/60mL N 20181231 41250-801_188f8ca6-c9c2-417f-a461-fa0eabf3b11c 41250-801 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170712 ANDA ANDA072096 Meijer, Inc. IBUPROFEN 200 mg/1 N 20181231 41250-802_bfe37210-b322-4edb-8ff2-aff9b3e66be0 41250-802 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170303 ANDA ANDA075077 Meijer Distribution Inc ACETAMINOPHEN 650 mg/1 N 20181231 41250-803_a37fdf8e-cef1-467d-b474-54197f2291f3 41250-803 HUMAN OTC DRUG Pain Relief Pain Relief PM Acetaminophen, Diphenhydramine HCl KIT 20131206 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc N 20181231 41250-804_58e7bfdc-f639-49b9-8041-401b87b1aef6 41250-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution ISOPROPYL ALCOHOL .91 mg/mL N 20181231 41250-806_3cba4005-ebce-41ba-b856-d54eb719708b 41250-806 HUMAN OTC DRUG Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20170712 NDA NDA022032 Meijer Distribution Inc OMEPRAZOLE 20 mg/1 N 20181231 41250-808_75a23642-86be-4ad2-88a2-aa9c4c02e8f4 41250-808 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution TRICLOSAN .46 mg/mL N 20181231 41250-811_07b4983f-d67e-4c3c-9cea-eb9e7ca12a44 41250-811 HUMAN OTC DRUG nitetime cold and flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20150723 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 41250-816_79bd1409-1d4a-4c33-864a-21bb1e68e5ff 41250-816 HUMAN OTC DRUG Dandruff Selenium sulfide SHAMPOO TOPICAL 20130601 OTC MONOGRAPH FINAL part358H Meijer Distribution SELENIUM SULFIDE 10 mg/mL N 20181231 41250-817_0ee289a2-f6d4-4c6f-8813-a2f4d8dd0836 41250-817 HUMAN OTC DRUG Nasal oxymetazoline hydrochloride SPRAY NASAL 19961213 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41250-821_1ec8cd03-5c0f-4943-bf18-b1957758ed5f 41250-821 HUMAN OTC DRUG Meijer Intense Healing Hydrocortisone CREAM TOPICAL 20170217 OTC MONOGRAPH NOT FINAL part348 Meijer, Inc. HYDROCORTISONE 1 g/100g N 20181231 41250-822_03e70f79-caf5-46c6-9742-7e1b733ce8d1 41250-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19960315 OTC MONOGRAPH FINAL part347 Meijer Distribution, Inc WITCH HAZEL 86 kg/100L N 20181231 41250-825_2164a8b4-4176-497d-8019-b7d75e35a987 41250-825 HUMAN OTC DRUG Miconazole 7 Miconazole nitrate CREAM VAGINAL 20000204 ANDA ANDA074760 Meijer Distribution Inc MICONAZOLE NITRATE 2 g/100g N 20181231 41250-826_fd2db85f-911a-4abf-a93a-e3fbe8e861ca 41250-826 HUMAN OTC DRUG Mint Cetylpyridinium Chloride MOUTHWASH ORAL 20090514 OTC MONOGRAPH NOT FINAL part356 MeijerDistribution, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 41250-827_814ee535-9c96-4942-8498-c377e9818873 41250-827 HUMAN OTC DRUG Meijer Baby Quick Relief Diaper Rash Zinc Oxide CREAM TOPICAL 20130501 OTC MONOGRAPH FINAL part347 Meijer Distribution Inc. ZINC OXIDE 13 g/100g N 20181231 41250-831_a7686f2f-fe89-40ce-a4b7-7464035b8f92 41250-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 20041222 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MINERAL OIL 999 mg/mL N 20181231 41250-835_5bf41d0e-252e-4f01-92e6-f4e61ad2e907 41250-835 HUMAN OTC DRUG Earwax Removal Kit CARBAMIDE PEROXIDE LIQUID TOPICAL 20141127 OTC MONOGRAPH FINAL part344 Meijer Distribution Inc. CARBAMIDE PEROXIDE 65 mg/mL N 20181231 41250-836_b6592aba-78c6-4d93-a2e4-f72eb2e239af 41250-836 HUMAN OTC DRUG Itchy Scalp Pyrithione zinc SHAMPOO TOPICAL 20131213 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 10.3 mg/mL N 20181231 41250-837_5903488e-0eb3-4dbf-af0c-082f5f0dd790 41250-837 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 19960828 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41250-839_70c12306-941e-4769-967e-ac111e0d9bc8 41250-839 HUMAN OTC DRUG childrens multi symptom cold dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20140917 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 41250-840_0f019632-eb3e-49ff-b431-793fae149f76 41250-840 HUMAN OTC DRUG DayTime/NiteTime Severe Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Doxylamine Succinate, Phenylephrine HCl KIT 20150801 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc N 20181231 41250-845_b10f5335-06cf-4d53-b3d7-f493e4910d01 41250-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090514 OTC MONOGRAPH FINAL part344 Meijer Distribution, Inc ISOPROPYL ALCOHOL 613 mg/mL N 20181231 41250-849_65b0d05f-ab10-475a-8cc6-cf4bc8c65ce3 41250-849 HUMAN OTC DRUG Sinus and Headache Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20170328 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 41250-850_deb5444b-aedb-4999-a39d-5b8a8067ed2a 41250-850 HUMAN OTC DRUG Children Pain Relief For Ages 2 to 11 Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/1 N 20181231 41250-852_08e3204b-a9f7-41d0-9dfa-c9ce22b3396f 41250-852 HUMAN OTC DRUG acid reducer Ranitidine TABLET, FILM COATED ORAL 20130823 ANDA ANDA091429 Meijer Distribution Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 41250-854_7f4c3559-8910-4d51-8887-9832964f3e6c 41250-854 HUMAN OTC DRUG Nicotine Nicotine polacrilex GUM, CHEWING ORAL 19920221 ANDA ANDA078546 Meijer Distribution Inc NICOTINE 4 mg/1 N 20181231 41250-855_ad77204f-b561-4c64-bb8a-433b96f3ea78 41250-855 HUMAN OTC DRUG Tartar control Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20140220 OTC MONOGRAPH NOT FINAL part356 Meijer Distribution, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41250-862_f661d25a-cafa-42f2-b50d-165cf7b343ab 41250-862 HUMAN OTC DRUG Allergy and Sinus PE Maximum Strength Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20050609 20200329 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 41250-866_056bad65-3438-4e16-b4ec-e87d32d79342 41250-866 HUMAN OTC DRUG lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070815 OTC MONOGRAPH FINAL part358G Meijer Distribution Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 41250-870_bdb9b057-69f2-4ac7-b013-4747dcccfbf4 41250-870 HUMAN OTC DRUG Itchy Eye Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140123 ANDA ANDA077958 Meijer Distribution Inc KETOTIFEN FUMARATE .35 mg/mL N 20181231 41250-871_c7e38308-41fb-4721-97db-05c4d53c15ea 41250-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc HYDROGEN PEROXIDE .3 kg/100L N 20181231 41250-872_4f6e1aae-df0c-4d69-8b7c-fd4be2c82989 41250-872 HUMAN OTC DRUG nitetime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 19891215 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 41250-873_dd2bb924-8660-4b45-84a7-c55dfaf90b4e 41250-873 HUMAN OTC DRUG nicotine Nicotine Polacrilex LOZENGE ORAL 20060301 ANDA ANDA077007 Meijer Distribution Inc NICOTINE 4 mg/1 N 20181231 41250-875_36bd69a2-a134-48a5-8975-922417d056a0 41250-875 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 20200329 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 N 20181231 41250-876_83db47f0-fb0e-4850-b473-c4106eaee91c 41250-876 HUMAN OTC DRUG acid reducer Ranitidine TABLET, COATED ORAL 20170531 ANDA ANDA076195 Meijer Distribution Inc RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 41250-877_ed3608c4-c35b-4bd7-a4b3-345849f20289 41250-877 HUMAN OTC DRUG Nite time Severe Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl TABLET, FILM COATED ORAL 20150801 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20191231 41250-881_f7e19ff6-9be3-4c9d-9244-f884d92ba2bc 41250-881 HUMAN OTC DRUG Antacid calcium carbonate TABLET, CHEWABLE ORAL 20170524 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 1000 mg/1 N 20181231 41250-882_640bfec6-c6d5-4a05-b46f-fb38dd0c3a63 41250-882 HUMAN OTC DRUG gas relief infants Simethicone EMULSION ORAL 19990201 OTC MONOGRAPH FINAL part332 Meijer Distribution Inc DIMETHICONE 20 mg/.3mL N 20181231 41250-884_cb1c65d7-b7cf-43b1-8968-7b851b8b3714 41250-884 HUMAN OTC DRUG Allergy Childrens 24 Hour cetirizine Hydrochloride LIQUID ORAL 20110114 ANDA ANDA090254 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 41250-897_53f31250-bed1-448d-a637-4d7cb14a17b0 41250-897 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990105 ANDA ANDA074937 Meijer Distribution Inc IBUPROFEN 100 mg/5mL N 20181231 41250-898_0dd8d737-09bb-47fb-9d79-36e23b8d4f4b 41250-898 HUMAN OTC DRUG Antibacterial Body Wash Benzalkonium chloride LOTION TOPICAL 20150210 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc BENZALKONIUM CHLORIDE 1.313 mg/mL N 20181231 41250-899_8af9367e-aa0b-4f9e-a7df-737d5411bc3c 41250-899 HUMAN OTC DRUG cough dm childrens Dextromethorphan polistirex SUSPENSION ORAL 20150325 ANDA ANDA091135 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 41250-900_126c269b-260d-40f4-879d-169c09251c67 41250-900 HUMAN OTC DRUG esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170922 ANDA ANDA207193 Meijer Distribution Inc ESOMEPRAZOLE 20 mg/1 N 20181231 41250-901_a9dc8e07-1c4a-4051-9154-ace84eaf47ff 41250-901 HUMAN OTC DRUG Smooth Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20170621 OTC MONOGRAPH FINAL part331 Meijer Distribution Inc CALCIUM CARBONATE 750 mg/1 N 20181231 41250-906_02df5a1e-ac6a-4de5-ad2a-da1c1c8fd28e 41250-906 HUMAN OTC DRUG cold and allergy childrens phenylephrine hcl, brompheniramine maleate SOLUTION ORAL 20060825 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 41250-907_2489f554-cd21-4f26-b70a-c917548c58fa 41250-907 HUMAN OTC DRUG Medicated Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 6; 10 g/100g; g/100g; g/100g N 20181231 41250-909_5e9fb560-5f41-4c79-8ead-716bc0136412 41250-909 HUMAN OTC DRUG Beauty Hydrating Octinoxate, Zinc Oxide LOTION TOPICAL 20061108 OTC MONOGRAPH NOT FINAL part352 Meijer OCTINOXATE; ZINC OXIDE 61.2; 30.6 mg/mL; mg/mL N 20181231 41250-910_fc965a1e-2380-4663-81a0-347ed7bc4d91 41250-910 HUMAN OTC DRUG cough plus chest congestion adult dm max Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20141030 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 41250-911_3f7243d9-de2f-4e84-8e89-bb3feaf41ec5 41250-911 HUMAN OTC DRUG childrens ibuprofen oral suspension Ibuprofen SUSPENSION ORAL 20020319 ANDA ANDA074937 Meijer Distribution Inc IBUPROFEN 100 mg/5mL N 20181231 41250-912_c33559b8-7239-4bc6-be99-12188c8bbb8a 41250-912 HUMAN OTC DRUG Charcoal Blackhead Clearing Scrub Salicylic Acid CREAM TOPICAL 20160301 OTC MONOGRAPH FINAL part333D Meijer Distribution, Inc. SALICYLIC ACID 20.6 mg/mL N 20181231 41250-913_f993fac0-69d8-499d-a123-df1918cd34ce 41250-913 HUMAN OTC DRUG cold and cough Diphenhydramine HCl, Phenylephrine HCl SOLUTION ORAL 20071031 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE 2.5; 6.25 mg/5mL; mg/5mL N 20181231 41250-915_fd45de80-c450-467f-9bfa-45a21841fead 41250-915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080229 NDA NDA022032 Meijer Distribution Inc OMEPRAZOLE 20 mg/1 N 20181231 41250-918_acf73822-fa09-4775-9c48-99ab3069fd4b 41250-918 HUMAN OTC DRUG Zinc Cold Remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20140210 UNAPPROVED HOMEOPATHIC Meijer Distribution Inc ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 41250-920_f30e511b-d207-478c-b0cc-b3a66e205b5b 41250-920 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20160323 ANDA ANDA206581 Meijer Distribution Inc IBUPROFEN SODIUM 256 mg/1 N 20181231 41250-921_bfb8ca56-0bb9-4f00-986a-c7eb1e62339d 41250-921 HUMAN OTC DRUG meijer Baby Tear Free SPF 50 CS Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY TOPICAL 20160311 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 6 g/100g; g/100g; g/100g; g/100g N 20181231 41250-922_30b55268-f297-4218-bd20-fb0959a85333 41250-922 HUMAN OTC DRUG Meijer Kids Tear Free SPF 50 Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution, Inc. TITANIUM DIOXIDE; ZINC OXIDE 3.2; 4 g/100g; g/100g N 20181231 41250-924_25a440e2-1bfa-4137-aa38-f45d03f67497 41250-924 HUMAN OTC DRUG Meijer Sport SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g N 20181231 41250-925_31dcdddf-436d-4f21-bc79-fbff54595646 41250-925 HUMAN OTC DRUG Meijer Sport SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160310 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 11.7; 4.5; 4.5; 5.4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 41250-927_c40b9940-5432-43ed-8f6e-5aeb8eead630 41250-927 HUMAN OTC DRUG Meijer Elements Maximum Strength For Diaper Rash Zinc Oxide PASTE TOPICAL 20130501 OTC MONOGRAPH FINAL part347 Meijer Distribution Inc. ZINC OXIDE 40 g/100g N 20181231 41250-928_6b89beab-4f70-40c8-b96c-4b0c44767d6a 41250-928 HUMAN OTC DRUG Meijer Kids Tear Free SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY TOPICAL 20160311 OTC MONOGRAPH NOT FINAL part352 Meijer Distribution, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 6 g/100g; g/100g; g/100g; g/100g N 20181231 41250-931_eb06ec42-f7ff-4661-b2f9-27975d0d27e2 41250-931 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20130726 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 41250-933_31d6bb8b-cb35-4346-8580-ec5a63ddce9c 41250-933 HUMAN OTC DRUG 24 hour allergy relief nasal Fluticasone propionate SPRAY, METERED NASAL 20161117 ANDA ANDA207957 Meijer Distribution Inc FLUTICASONE PROPIONATE 50 ug/1 N 20191231 41250-939_10ae0abc-3f2b-4fad-9bf9-2dc384612f7f 41250-939 HUMAN OTC DRUG clear lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20170712 ANDA ANDA090685 Meijer Distribution Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 41250-940_602d29e1-c82c-d8c5-e053-2a91aa0ae7fd 41250-940 HUMAN OTC DRUG Meijer Anti-itch with Aloe Hydrocortisone CREAM TOPICAL 20150114 OTC MONOGRAPH NOT FINAL part348 Meijer, Inc. HYDROCORTISONE 1 g/100g N 20181231 41250-941_2728304d-05ac-4bfe-adb0-198e2324eb3b 41250-941 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20141217 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 41250-942_72928954-64e1-472f-a1eb-20b32b1eb7db 41250-942 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution, Inc BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 41250-943_602d0c43-53bd-d221-e053-2a91aa0a81a9 41250-943 HUMAN OTC DRUG Meijer Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine HCI CREAM TOPICAL 20150119 OTC MONOGRAPH NOT FINAL part347 Meijer, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g N 20181231 41250-944_fb170371-2e5d-43ca-a259-538a973ee3b8 41250-944 HUMAN OTC DRUG hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20080206 OTC MONOGRAPH FINAL part346 Meijer Distribution Inc GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 41250-946_b64d2f5f-6eef-4aa9-81ef-b32376244930 41250-946 HUMAN OTC DRUG pain and fever Acetaminophen SUSPENSION ORAL 20110826 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/5mL N 20181231 41250-947_a8bd84d4-a1c5-40ad-88b7-c82acf6317cc 41250-947 HUMAN OTC DRUG Oil Free Acne Wash Salicylic Acid 2% LOTION TOPICAL 20090514 OTC MONOGRAPH FINAL part333D Meijer Distribution, Inc SALICYLIC ACID 20.6 mg/mL N 20181231 41250-948_10abe4ad-2076-4181-8a55-0b3817937094 41250-948 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 160 mg/1 N 20181231 41250-949_32afe9a4-1426-449b-9f90-77b0742e779c 41250-949 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20041018 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 41250-950_ffc1ee8d-2200-4e6c-b83c-248d09deefa0 41250-950 HUMAN OTC DRUG acid reducer Ranitidine TABLET, FILM COATED ORAL 20110921 ANDA ANDA091429 Meijer Distribution Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 41250-952_0db8fcee-d191-4206-bb33-9b1488add2a3 41250-952 HUMAN OTC DRUG Dry Scalp Pyrithions Zinc SHAMPOO TOPICAL 19970916 OTC MONOGRAPH FINAL part358H Meijer Distribution, Inc PYRITHIONE ZINC 1 g/100mL N 20181231 41250-953_2515c7e2-d9a1-4063-a59a-52171d5adbe7 41250-953 HUMAN OTC DRUG Nasal Decongestant PE Maximum Strength Phenylephrine HCl TABLET ORAL 20050114 20200329 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 41250-957_fa727766-8036-4e20-b1b8-14ffbeb70a21 41250-957 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130118 ANDA ANDA203690 Meijer Distribution Inc NICOTINE 4 mg/1 N 20181231 41250-958_33f64e46-cb69-4b01-992d-ed6907d35697 41250-958 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130708 ANDA ANDA091135 Meijer Distribution Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 41250-962_8abecf27-434c-44c6-9ddc-cd139b5bd832 41250-962 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part333A Meijer Distribution TRICLOSAN .46 mg/mL N 20181231 41250-966_bf81d30a-cb27-4eb9-a3bf-efaed727aa0d 41250-966 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070905 ANDA ANDA075077 Meijer Distribution Inc ACETAMINOPHEN 650 mg/1 N 20181231 41250-968_50957af4-8778-4fdf-b336-3b99f4b4e20f 41250-968 HUMAN OTC DRUG Allergy Relief Nighttime Diphenhydramine HCl TABLET ORAL 20150120 20190302 OTC MONOGRAPH FINAL part341 Meijer DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 41250-969_6748ee16-8829-46fd-a2a6-31837c110a08 41250-969 HUMAN OTC DRUG pain relief and pain relief pm Acetaminophen, Diphenhydramine HCl KIT 20051019 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc N 20181231 41250-970_1ec33e70-64fe-4ed9-8c07-fc56b707249e 41250-970 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 20141031 OTC MONOGRAPH FINAL part341 MEIJER, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41250-971_904b1405-8999-4a0c-8bf1-d724e36e37e9 41250-971 HUMAN OTC DRUG Anticavity Sodium Fluoride RINSE ORAL 20130211 OTC MONOGRAPH FINAL part355 Meijer Distribution, Inc SODIUM FLUORIDE .02 mg/mL N 20181231 41250-972_1bd2cdc8-1f1c-44d5-9126-a7f9f6a7fad8 41250-972 HUMAN OTC DRUG MEIJER PAIN RELIEF PATCHES LIDOCAINE PATCH TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part348 Meijer Distribution Inc LIDOCAINE 4 g/100g N 20181231 41250-974_f4906234-dcdd-4946-81e3-8077bdb351de 41250-974 HUMAN OTC DRUG 24 hour allergy cetirizine hydrochloride LIQUID ORAL 20080416 ANDA ANDA090254 Meijer Distribution Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 41250-975_0a535865-54cb-42c2-b423-d820c0e0bb8d 41250-975 HUMAN OTC DRUG pain relief Acetaminophen TABLET ORAL 19950426 OTC MONOGRAPH NOT FINAL part343 Meijer Distribution Inc ACETAMINOPHEN 500 mg/1 N 20181231 41250-982_c915a495-8eac-4a1a-83a4-c874682433c8 41250-982 HUMAN OTC DRUG Miconazole 3 Miconazole nitrate KIT 20161012 ANDA ANDA076357 Meijer Distribution Inc N 20181231 41250-983_f7d23235-7eec-42be-90f7-6e145fb2b289 41250-983 HUMAN OTC DRUG congestion and headache Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20170724 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41250-987_1d63d4a9-c482-4898-85ef-72a6cd164e33 41250-987 HUMAN OTC DRUG cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20060811 OTC MONOGRAPH FINAL part341 Meijer Distribution Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 41250-991_9ce46dd3-0bd7-49d2-97fc-35050d50a867 41250-991 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Meijer Distribution Inc IBUPROFEN 200 mg/1 N 20181231 41250-992_3ec57bba-271a-44a0-9f8c-2891121d9e6c 41250-992 HUMAN OTC DRUG Childrens pain and fever Acetaminophen SUSPENSION ORAL 20170712 OTC MONOGRAPH NOT FINAL part343 Meijer, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 41250-993_1f8d0810-f971-4501-b78c-9bbe3e80f67b 41250-993 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020408 ANDA ANDA075139 Meijer Distribution Inc IBUPROFEN 200 mg/1 N 20181231 41250-998_c1f039f0-7152-4fbf-952d-24bc0960860a 41250-998 HUMAN OTC DRUG Glazed Pear Ethyl Alcohol GEL TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Meijer Distributioin, Inc ALCOHOL 62 mg/mL N 20181231 41250-999_4905d89c-a40c-40ef-bbad-b3dfe93c59c4 41250-999 HUMAN OTC DRUG meijer Childrens 24 Hour Allergy Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Meijer Distribution Inc LORATADINE 5 mg/5mL N 20181231 41268-041_1ec98cf8-c216-4516-b4ee-4332505795f8 41268-041 HUMAN OTC DRUG NightTime acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20060621 OTC MONOGRAPH FINAL part341 Hannaford Brothers Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 41268-302_e7c71ec8-1d75-458d-924b-97c3347b0993 41268-302 HUMAN OTC DRUG Stomach Relief Original Strength Bismuth subsalicylate LIQUID ORAL 19950615 OTC MONOGRAPH FINAL part335 Hannaford Brothers Company BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 41268-600_60e03bbc-0fdc-5e64-e053-2991aa0a4426 41268-600 HUMAN OTC DRUG Hand Wipes antibacterial Benzalkonium chloride CLOTH TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part333A Hannaford Brothers Company BENZALKONIUM CHLORIDE .115 g/1 N 20181231 41391-119_efeb468c-631c-4c9f-ba4c-7e1576c277c2 41391-119 HUMAN OTC DRUG Myo-Breathe Menthol GEL TOPICAL 20090110 OTC MONOGRAPH NOT FINAL part348 Myo-Breathe,LLC MENTHOL 40 mg/mL E 20171231 41391-120_52bfd151-d250-4696-9690-38b5be8b2ea3 41391-120 HUMAN OTC DRUG Myo-Breathe Menthol SPRAY TOPICAL 20150215 OTC MONOGRAPH NOT FINAL part348 Myo-Breathe,LLC MENTHOL 100 mg/mL E 20171231 41391-121_22fc0589-e2b6-4bbe-9933-bc3c64eca929 41391-121 HUMAN OTC DRUG Arnica Performance Gel Arnica Montana GEL TOPICAL 20150625 UNAPPROVED DRUG OTHER Myo-Breathe,LLC ARNICA MONTANA 150 mg/mL E 20171231 41415-001_46f1f990-7dc5-027b-e054-00144ff8d46c 41415-001 HUMAN OTC DRUG Menthol cough drop Menthol LOZENGE ORAL 20130731 OTC MONOGRAPH FINAL part341 Publix MENTHOL 5.4 mg/1 N 20181231 41415-002_470691a3-b854-3955-e054-00144ff88e88 41415-002 HUMAN OTC DRUG Menthol cough drop Cherry LOZENGE ORAL 20130731 OTC MONOGRAPH FINAL part341 Publix MENTHOL 5.8 mg/1 N 20181231 41415-003_47935f19-cbb1-6bf8-e054-00144ff8d46c 41415-003 HUMAN OTC DRUG Honey lemon menthol cough drop Honey Lemon LOZENGE ORAL 20130731 OTC MONOGRAPH FINAL part341 Publix MENTHOL 7.5 mg/1 N 20181231 41415-004_47def1e5-fd4d-337b-e054-00144ff8d46c 41415-004 HUMAN OTC DRUG Sugar Free Menthol cough drop menthol LOZENGE ORAL 20120622 OTC MONOGRAPH FINAL part341 Publix MENTHOL 5.8 mg/1 N 20181231 41415-005_47f655d4-e410-3988-e054-00144ff8d46c 41415-005 HUMAN OTC DRUG SF menthol cough drop SF Cherry LOZENGE ORAL 20130622 OTC MONOGRAPH FINAL part341 Publix MENTHOL 5.8 mg/1 N 20181231 41415-006_480628ca-cf9e-001b-e054-00144ff8d46c 41415-006 HUMAN OTC DRUG SF menthol cough drop Honey Lemon LOZENGE ORAL 20150911 OTC MONOGRAPH FINAL part341 Publix MENTHOL 7.6 mg/1 N 20181231 41415-046_9dca0d42-305b-40f9-8142-a647f4acee07 41415-046 HUMAN OTC DRUG Publix allergy diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH FINAL part348 Publix Super Markets Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 41415-047_82d19ede-7cb1-456a-99be-0088e54c18d1 41415-047 HUMAN OTC DRUG Publix Hydro Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Publix Super Markets Inc HYDROCORTISONE 1 g/100g N 20181231 41415-048_f82ebb8d-188a-4b7e-b180-814a08498001 41415-048 HUMAN OTC DRUG Publix hydro plus Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Publix Super Markets Inc HYDROCORTISONE 1 g/100g N 20181231 41415-049_994801ff-18f6-4f2b-a033-4adef321a1b6 41415-049 HUMAN OTC DRUG Publix antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Publix Super Markets Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 41415-050_ce87048b-b96f-4b61-bf17-69d8a447b5e1 41415-050 HUMAN OTC DRUG Publix antibiotic plus pain relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Publix Super Markets Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 41415-051_6de8fc94-d9a5-4d93-b025-3d2a31e5e036 41415-051 HUMAN OTC DRUG Publix Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Publix Super Markets Inc BACITRACIN ZINC 500 [iU]/g N 20181231 41415-056_840b3bc9-48c9-4b16-ad4c-ca31c5037776 41415-056 HUMAN OTC DRUG Publix athletic foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Publix Super Markets Inc CLOTRIMAZOLE 10 mg/g N 20181231 41415-076_d19f0b93-6d58-4590-ab20-cdb8de757249 41415-076 HUMAN OTC DRUG Publix antibiotic plus Pain Relief Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Publix Super Markets Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 41415-120_e54a27b1-ad9f-48f9-87e4-2c033c008ce1 41415-120 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B OINTMENT TOPICAL 20151215 OTC MONOGRAPH FINAL part333B Publix Super Markets Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 41415-124_2a316e06-5c16-46b8-b9ac-71fe0f92c515 41415-124 HUMAN OTC DRUG Chewable Stomach Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20170630 OTC MONOGRAPH FINAL part335 PUBLIX SUPER MARKETS INC, BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 41415-210_eea2cc09-e468-4bae-bbfc-8f0ed9df1fb9 41415-210 HUMAN OTC DRUG Advanced Citrus Antiseptic Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 20010503 OTC MONOGRAPH NOT FINAL part356 Publix Supermarkets, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L N 20181231 41415-325_5d6b7cf1-1e13-7ea8-e053-2a91aa0a58d3 41415-325 HUMAN OTC DRUG Publix Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Publix POVIDONE-IODINE 100 mg/mL N 20181231 41415-400_5d6b905f-ed24-1ab7-e053-2a91aa0a816b 41415-400 HUMAN OTC DRUG Publix Clear Anti-Itch Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Publix ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 41415-420_5d6bba46-2554-4957-e053-2a91aa0a2e85 41415-420 HUMAN OTC DRUG Publix Calamine Medicated Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Publix ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 41442-110_33b6c804-5246-4826-8e76-6d9b636948c3 41442-110 HUMAN OTC DRUG Complexion Enhancer SPF15 Titanium dioxide and Zinc oxide CREAM TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft. TITANIUM DIOXIDE; ZINC OXIDE .75; 1.6 mL/50mL; mL/50mL E 20171231 41442-123_8967b214-754c-4655-adf8-c51b95e94253 41442-123 HUMAN OTC DRUG Complexion Brightener SPF20 Titanium dioxide and Zinc oxide CREAM TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft. TITANIUM DIOXIDE; ZINC OXIDE .84; 2.1 mL/30mL; mL/30mL E 20171231 41442-133_99c23df0-8293-412b-b9a6-3b72fadc024a 41442-133 HUMAN OTC DRUG Sunkiss SPF15 titanium dioxide and zinc oxide CREAM TOPICAL 20110506 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft TITANIUM DIOXIDE; ZINC OXIDE .675; 3 mL/50mL; mL/50mL E 20171231 41442-143_68ceb3b7-b0ff-4ecb-a663-eeecee917e60 41442-143 HUMAN OTC DRUG Complexion Perfector BB SPF20 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120227 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft. TITANIUM DIOXIDE; ZINC OXIDE 2.2; 3.7 mL/50mL; mL/50mL E 20171231 41442-149_78efc956-0494-456a-ba69-3941dd949e91 41442-149 HUMAN OTC DRUG Complexion Corrector SPF20 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20130125 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft. TITANIUM DIOXIDE; ZINC OXIDE 28; 70 mg/mL; mg/mL E 20171231 41442-150_496c67cd-cbed-4931-8cd5-04c35c531746 41442-150 HUMAN OTC DRUG Complexion Perfector BB SPF20 Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20130318 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft. TITANIUM DIOXIDE; ZINC OXIDE 62; 74 mg/mL; mg/mL E 20171231 41442-152_1551287e-cb70-4833-9c37-5c2d5c0a5bb7 41442-152 HUMAN OTC DRUG Mineral UV Shield SPF30 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Omorovicza Kozmetikai Kft. TITANIUM DIOXIDE; ZINC OXIDE 15; 86 mg/mL; mg/mL E 20171231 41477-420_dad1ae70-b04b-4a43-9001-9d0a39df9104 41477-420 HUMAN OTC DRUG FIRSTLINE MEDICAL the i-stick Povidone-Iodine Antiseptic Ampules POVIDONE-IODINE LIQUID TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333A The Wild Side, Llc dba Firstline Medical POVIDONE-IODINE 100 mg/mL N 20181231 41499-105_9445eaa1-1039-487f-baa3-3e9b28d9f43d 41499-105 HUMAN OTC DRUG Amar Petroleum All Purpose Adults Petrolatum JELLY TOPICAL 20100501 OTC MONOGRAPH FINAL part347 Amar Remedies Limited PETROLATUM 99.8 g/100g E 20171231 41499-106_2afb264a-4297-4573-8c55-0d20ca4d62bb 41499-106 HUMAN OTC DRUG Amar Regular Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20091201 OTC MONOGRAPH FINAL part355 Amar Remedies Limited - Mumbai SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 41499-107_356bdab6-1be3-49ca-aacb-98bca738b55a 41499-107 HUMAN OTC DRUG Amar Advanced Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20091201 OTC MONOGRAPH FINAL part355 Amar Remedies Limited - Mumbai SODIUM FLUORIDE .22 g/100g E 20171231 41499-122_ea0fd21e-543e-452d-a5a5-cb271224eed0 41499-122 HUMAN OTC DRUG Amar Vaporizing Chest Rub Camphor (Synthetic), Eucalyptus Oil, and Menthol OINTMENT TOPICAL 20100501 OTC MONOGRAPH FINAL part341 Amar Remedies Limited - Mumbai CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 5.25; 1.6; 3.15 g/100g; g/100g; g/100g E 20171231 41499-123_dfe38d4d-50ba-41f2-afbd-772970bc3cff 41499-123 HUMAN OTC DRUG Amar Ice Menthol GEL TOPICAL 20100501 OTC MONOGRAPH FINAL part341 AMAR REMEDIES LIMITED MENTHOL 2.5 g/100g E 20171231 41499-124_db5a0d57-fdd3-4404-934c-fcc80ea2ccda 41499-124 HUMAN OTC DRUG Amar Petroleum with Aloe Vera Petrolatum JELLY TOPICAL 20110701 OTC MONOGRAPH FINAL part347 Amar Remedies Limited PETROLATUM 99.8 g/100g E 20171231 41499-125_d6f52cbe-b2e0-45ff-b44e-82e401777160 41499-125 HUMAN OTC DRUG Amar Petroleum Cocoa Butter Scented Petrolatum JELLY TOPICAL 20110701 OTC MONOGRAPH FINAL part347 Amar Remedies Limited PETROLATUM 99.8 g/100g E 20171231 41520-001_b9acdd06-3108-4e18-8e0b-e752ffb57148 41520-001 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20090803 OTC MONOGRAPH FINAL part347 American Sales Company LANOLIN; PETROLATUM 133; 459 mg/g; mg/g N 20181231 41520-003_3502059b-bf25-453e-be86-b05598e514a1 41520-003 HUMAN OTC DRUG Creamy Petroleum White petrolatum JELLY TOPICAL 20090129 OTC MONOGRAPH FINAL part347 Foodhold USA, LLC PETROLATUM .3 mg/100g N 20181231 41520-004_f10ecaea-8761-4f84-94eb-9706a1d17b65 41520-004 HUMAN OTC DRUG careone hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141221 OTC MONOGRAPH FINAL part346 American Sales Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 41520-005_4160b78a-b466-4df8-882c-e482f168550d 41520-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 American Sales Company SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 41520-006_6d3e7dd5-97c9-44ce-b97d-4e76331cb83e 41520-006 HUMAN OTC DRUG Careone Aloe and Vitamin E Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20170925 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 650 mg/mL N 20181231 41520-006_a79b5859-75cb-4b98-b076-ada78dbf30ef 41520-006 HUMAN OTC DRUG Careone Aloe and Vitamin E Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20171018 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 650 mg/mL N 20181231 41520-007_672ee961-c33f-45bd-bd85-e65d26986df2 41520-007 HUMAN OTC DRUG careone fluticasone propionate Fluticasone propionate SPRAY, METERED NASAL 20160613 ANDA ANDA207957 American Sales Company FLUTICASONE PROPIONATE 50 ug/1 N 20181231 41520-009_61d22ce5-614a-f29f-e053-2a91aa0a1aa0 41520-009 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20160609 OTC MONOGRAPH FINAL part341 American Sales MENTHOL 5.4 mg/1 N 20191231 41520-011_47f504d5-3ec6-5227-e054-00144ff88e88 41520-011 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20160622 OTC MONOGRAPH FINAL part341 American Sales MENTHOL 7.5 mg/1 N 20181231 41520-012_5c680e78-5d4a-4283-b051-559ce2cfcf0c 41520-012 HUMAN OTC DRUG Pain Relief ES Acetaminophen TABLET ORAL 20140610 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 500 mg/1 N 20181231 41520-013_4a5356c5-06f6-45d8-9b07-3c0867a2287b 41520-013 HUMAN OTC DRUG CareOne Allergy and congestion relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120821 ANDA ANDA076050 American Sales Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 41520-015_45ea34d5-1b97-6645-e054-00144ff88e88 41520-015 HUMAN OTC DRUG Fruit Smoothers Throat Drop Pectin LOZENGE ORAL 20160609 OTC MONOGRAPH NOT FINAL part356 American Sales PECTIN 7 mg/1 N 20181231 41520-016_7e943bcb-5e84-45eb-bcc7-d6b75afeea79 41520-016 HUMAN OTC DRUG CAREONE Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B American Sales Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 41520-017_e7a54c97-c0be-4c5a-a579-bb90532004e9 41520-017 HUMAN OTC DRUG Castor Oil Castor Oil LIQUID ORAL 20100811 OTC MONOGRAPH NOT FINAL part334 FOODHOLD U.S.A., LLC CASTOR OIL 1 g/mL N 20181231 41520-019_43691609-6160-44e6-acf5-38c95cb54a64 41520-019 HUMAN OTC DRUG Gentle Laxative Stimulant Laxative Bisacodyl TABLET, COATED ORAL 20100930 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) BISACODYL 5 mg/1 N 20181231 41520-020_4893ac0a-776a-5657-e054-00144ff8d46c 41520-020 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20160622 OTC MONOGRAPH FINAL part341 American Sales MENTHOL 5.8 mg/1 N 20181231 41520-021_4894cffb-d7f7-260b-e054-00144ff88e88 41520-021 HUMAN OTC DRUG Sugar Free Menthol cough drops menthol LOZENGE ORAL 20160622 OTC MONOGRAPH FINAL part341 American Sales MENTHOL 5.8 mg/1 N 20181231 41520-022_efd6b625-f947-4e6c-867f-a4a21b2bd9b8 41520-022 HUMAN OTC DRUG Stool Softener and Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20130301 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 41520-023_d01cb7d1-2360-4f63-b1e7-b0efd6feb469 41520-023 HUMAN OTC DRUG CareOne Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20160413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-024_f93a3f4b-21f3-4ede-a41c-7317c08fa2db 41520-024 HUMAN OTC DRUG CareOne Sinus Relief Severe Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20160902 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 41520-026_45e891ea-2f2b-31b7-e054-00144ff88e88 41520-026 HUMAN OTC DRUG Cherry cough drop Menthol LOZENGE ORAL 20160609 OTC MONOGRAPH FINAL part341 American Sales MENTHOL 5.8 mg/1 N 20181231 41520-028_14274dce-8135-4a4f-8df6-9ec91f36b630 41520-028 HUMAN OTC DRUG CareOne Sinus Plus Headache Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate KIT 20160921 OTC MONOGRAPH FINAL part341 American Sales Company N 20181231 41520-029_61d3044e-f744-d44d-e053-2a91aa0ac3a0 41520-029 HUMAN OTC DRUG mixed berry sore throat and cough lozenge benzocaine LOZENGE ORAL 20160609 OTC MONOGRAPH NOT FINAL part356 Ahold BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20191231 41520-030_76e85fb8-596c-442d-b904-a55ea94a6e16 41520-030 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 Care One (American Sales Company) ASPIRIN 81 mg/1 N 20181231 41520-031_49261864-e597-20e5-e054-00144ff8d46c 41520-031 HUMAN OTC DRUG cherry antacid soft chew calcium carbonate TABLET, CHEWABLE ORAL 20160622 OTC MONOGRAPH FINAL part331 American Sales CALCIUM CARBONATE 1177 mg/1 N 20181231 41520-032_605ddb43-0340-4ea2-babf-cbb2b2d9daf4 41520-032 HUMAN OTC DRUG CareOne DayTime Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20160412 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 41520-033_b04e80c2-b833-46db-9b98-0be4ce2ac396 41520-033 HUMAN OTC DRUG careone anti itch hydrocortisone CREAM TOPICAL 20160519 OTC MONOGRAPH NOT FINAL part348 American Sales Company HYDROCORTISONE 1 g/100g N 20181231 41520-034_be5db9de-2708-4425-91ae-eee0270690ed 41520-034 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 41520-035_4933a495-7e16-4bd2-e054-00144ff88e88 41520-035 HUMAN OTC DRUG Antacid Fruit Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20160622 OTC MONOGRAPH FINAL part331 American Sales CALCIUM CARBONATE 750 mg/1 N 20181231 41520-036_ce55c197-56ee-4f49-9b1a-59f02d2d9354 41520-036 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 41520-037_57c178b6-c30b-406b-82e3-11498c618e59 41520-037 HUMAN OTC DRUG Mucus Relief Maximum Strength Severe Congestion and Cough dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20191231 41520-038_456e453b-f146-4338-e054-00144ff88e88 41520-038 HUMAN OTC DRUG menthol cough drop menthol LOZENGE ORAL 20160609 OTC MONOGRAPH FINAL part341 American Sales MENTHOL 5.4 mg/1 N 20181231 41520-039_47f42a61-8560-359f-e054-00144ff8d46c 41520-039 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20160622 OTC MONOGRAPH FINAL part341 American Sales MENTHOL 5.8 mg/1 N 20181231 41520-040_47f76009-781c-6aac-e054-00144ff8d46c 41520-040 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20160622 OTC MONOGRAPH FINAL part341 American Sales MENTHOL 7.5 mg/1 N 20181231 41520-041_4d3c96b9-adbd-4596-a52a-42c2700fe6ff 41520-041 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20101214 OTC MONOGRAPH FINAL part333D Foodhold U.S.A.,LLC SALICYLIC ACID 19.8 mg/g N 20181231 41520-042_2f46a8f9-6c06-48b1-bf93-778593302917 41520-042 HUMAN OTC DRUG CARE ONE INSTANT SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20150528 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 700 mg/mL N 20181231 41520-042_45536b9e-a083-49ee-8608-f94ca09b174e 41520-042 HUMAN OTC DRUG Care One Instant Sanitizer Ethyl Alcohol LIQUID TOPICAL 20170517 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 700 mg/mL N 20181231 41520-043_49248a40-1ca4-6dd1-e054-00144ff88e88 41520-043 HUMAN OTC DRUG Cherry Sore Throat Lozenge Benzocaine LOZENGE ORAL 20160622 OTC MONOGRAPH NOT FINAL part356 American Sales MENTHOL; BENZOCAINE 3.6; 15 mg/1; mg/1 N 20181231 41520-044_48961fbb-7ff1-4c24-e054-00144ff8d46c 41520-044 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20160622 OTC MONOGRAPH FINAL part341 American Sales MENTHOL 5.8 mg/1 N 20181231 41520-045_4896cbd1-57de-1fc6-e054-00144ff8d46c 41520-045 HUMAN OTC DRUG Sugar Free Honey Lemon Cough Drops Menthol LOZENGE ORAL 20160622 OTC MONOGRAPH FINAL part341 American Sales MENTHOL 7.6 mg/1 N 20181231 41520-048_4897eb9a-ce5a-1f80-e054-00144ff88e88 41520-048 HUMAN OTC DRUG Herbal Cough Drops Menthol LOZENGE ORAL 20160622 OTC MONOGRAPH FINAL part341 American Sales MENTHOL 4.8 mg/1 N 20181231 41520-050_ab4aa5a0-9b2f-46cf-82fe-87fb0a117df0 41520-050 HUMAN OTC DRUG Care One Ibuprofen PM diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20090220 ANDA ANDA079113 American Sales Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 41520-051_05280804-a979-47c3-80d2-a3f6b578b65d 41520-051 HUMAN OTC DRUG Drowz Away Maximum strength Caffeine TABLET ORAL 20140305 OTC MONOGRAPH FINAL part340 Care One (American Sales Company) CAFFEINE 200 mg/1 N 20181231 41520-052_4f8a62db-1968-42a1-91f4-1fd97c6e07bf 41520-052 HUMAN OTC DRUG CareOne Nighttime Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140128 OTC MONOGRAPH FINAL part338 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41520-053_4ab3dcd8-9bdf-4d36-e054-00144ff8d46c 41520-053 HUMAN OTC DRUG grape throat relief pops pectin LOZENGE ORAL 20160623 OTC MONOGRAPH NOT FINAL part356 American Sales PECTIN 10 mg/1 N 20181231 41520-054_28cb9586-c10d-498b-a8f8-4bc223a87c2f 41520-054 HUMAN OTC DRUG careone suphedrine 12 hour relief non drowsy Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040511 ANDA ANDA075153 American Sales Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 41520-055_66934973-59db-458d-8f88-43e4228652d5 41520-055 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20150506 OTC MONOGRAPH NOT FINAL part334 FOODHOLD U.S.A., LLC MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 41520-056_e49550bf-026b-4713-ad8c-6a859bf8f37d 41520-056 HUMAN OTC DRUG Careone Lemon Meringue Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20170925 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 650 mg/mL N 20181231 41520-057_bf0f2b88-b100-441b-ab94-9096c774251e 41520-057 HUMAN OTC DRUG care one ibuprofen infants ibuprofen SUSPENSION ORAL 20040511 ANDA ANDA075217 American Sales Company IBUPROFEN 50 mg/1.25mL N 20191231 41520-058_64b5b6e4-4935-4d8a-8581-dc1240ba16a9 41520-058 HUMAN OTC DRUG Careone Vanilla Buttercream Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20170925 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 650 mg/mL N 20181231 41520-059_148eacf4-c370-44bc-88ee-85b7de3cc226 41520-059 HUMAN OTC DRUG Careone Vitamin E Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20170925 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 650 mg/mL N 20181231 41520-059_2bb35e09-600e-48b7-9776-826119a4556d 41520-059 HUMAN OTC DRUG Careone Vitamin E Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20171018 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 650 mg/mL N 20181231 41520-061_a82766e1-af46-4973-a60f-2c96313c8580 41520-061 HUMAN OTC DRUG CareOne Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-062_afb85075-54a2-445d-ae1a-4627bbf70f97 41520-062 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 41520-063_2a4d127b-0eff-41ed-94c7-8ad73ecba33d 41520-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20130206 OTC MONOGRAPH FINAL part347 FOODHOLD U.S.A. LLC FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 41520-064_079e5c56-3637-4968-a042-d99859e1dab3 41520-064 HUMAN OTC DRUG CareOne Acetaminophen Acetaminophen TABLET ORAL 20160720 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 500 mg/1 N 20181231 41520-065_32601109-9b14-49b4-98af-e4f4007cf5e6 41520-065 HUMAN OTC DRUG care one nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 20040601 OTC MONOGRAPH FINAL part341 American Sales Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41520-066_6403ac00-56df-5dfb-e053-2a91aa0af630 41520-066 HUMAN OTC DRUG Herbal Cough Drops Menthol LOZENGE ORAL 20180130 OTC MONOGRAPH FINAL part341 American Sales Company MENTHOL 4.8 mg/1 N 20191231 41520-068_7a33327a-e0ca-4727-93f0-1c27c40c3771 41520-068 HUMAN OTC DRUG Multi-Symptom Cold and Flu DayTime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20160731 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41520-069_8115bab8-22e6-4ab9-b3d2-b79d592983de 41520-069 HUMAN OTC DRUG Petrolatum White Petrolatum JELLY TOPICAL 19920715 OTC MONOGRAPH FINAL part347 Foodhold USA, LLC PETROLATUM 1 g/g N 20191231 41520-070_c6734ed0-9db7-4c41-b08b-59c4d9a8f68e 41520-070 HUMAN OTC DRUG Dry Scalp Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20060801 OTC MONOGRAPH FINAL part358H FOODHOLD U.S.A. LLC PYRITHIONE ZINC 10 mg/mL N 20181231 41520-071_2f158d0c-9c04-4429-ba44-8da789b2ba17 41520-071 HUMAN OTC DRUG Multi Symptom Nitetime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20151031 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 41520-074_7819db1e-41cd-4b24-bfb9-c6285fddce92 41520-074 HUMAN OTC DRUG care one ibuprofen ib Ibuprofen TABLET, COATED ORAL 20060509 ANDA ANDA077349 American Sales Company IBUPROFEN 200 mg/1 N 20181231 41520-075_5f033f8a-c34e-4fa0-ba3a-4f8c117af299 41520-075 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141031 NDA NDA021920 Care One (American Sales Company) NAPROXEN SODIUM 220 mg/1 N 20181231 41520-076_eb308349-f997-4748-808d-2cdd0edec392 41520-076 HUMAN OTC DRUG CAREONE Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B American Sales Company NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 41520-079_4e2e6915-0501-4ed9-a1d9-a3a0fe056d50 41520-079 HUMAN OTC DRUG CAREONE Instant Hand Sanitizer with Aloe and Vitamin E Ethyl Alcohol LIQUID TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 700 mg/mL N 20181231 41520-079_74d3ff13-7dde-4349-8959-89f23bd0cfe3 41520-079 HUMAN OTC DRUG CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ETHYL ALCOHOL LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 700 mg/mL N 20181231 41520-080_0fa5f25a-5ea8-4039-8716-8cfce68987d1 41520-080 HUMAN OTC DRUG Antifungal Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 American Sales Company TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 41520-082_8963363e-cc28-452a-8d3e-62d512bec59a 41520-082 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20171219 OTC MONOGRAPH FINAL part333C Foodhold USA TOLNAFTATE 1.5 g/150g N 20181231 41520-084_1a87473d-6743-41f8-9a02-18d62dfa2e9e 41520-084 HUMAN OTC DRUG CareOne Night TIme Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20160411 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 41520-085_c09b23f3-4ca7-44fd-aec5-7cf6e5f4253b 41520-085 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 American Sales Company LORATADINE 5 mg/5mL N 20181231 41520-086_ede8d9cd-2750-4bc0-befb-685537f6b23e 41520-086 HUMAN OTC DRUG Tolnaftate Foot Odor Control Spray AEROSOL, SPRAY TOPICAL 20171219 OTC MONOGRAPH FINAL part333C Foodhold USA TOLNAFTATE 1.13 g/113g N 20181231 41520-087_aad6d4a7-2111-41bc-b9d3-b3e0d610d413 41520-087 HUMAN OTC DRUG Miconazole Nitrate Jock Itch Spray AEROSOL, SPRAY TOPICAL 20171219 OTC MONOGRAPH FINAL part333C Foodhold USA MICONAZOLE NITRATE 1.3 g/131g N 20181231 41520-088_41eccd8b-f4cc-4dcc-93ed-07e33b42248b 41520-088 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20120103 OTC MONOGRAPH FINAL part333C Foodhold USA MICONAZOLE NITRATE 2.6 g/130g N 20181231 41520-089_f418a827-2bb7-4d0f-915a-b1f417d68f2d 41520-089 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part333A Foodhold USA BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/9mL; mg/9mL N 20181231 41520-091_8ca3ad2f-4662-48dd-a7b5-9740be402f87 41520-091 HUMAN OTC DRUG CareOne Allergy Relief D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20160720 ANDA ANDA077170 American Sales Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 41520-092_e823d719-dac1-4b49-aed1-b1d6201158cc 41520-092 HUMAN OTC DRUG Care One Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 American Sales Company LORATADINE 5 mg/5mL N 20181231 41520-093_933548d3-d813-4aaf-9328-180ed47ace5a 41520-093 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20120520 OTC MONOGRAPH NOT FINAL part343 Care One (American Sales Company) ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 41520-094_31058011-fd10-498a-82af-f5bdc425ec6a 41520-094 HUMAN OTC DRUG care one nasal decongestant pe maximum strength non drowsy Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20050517 OTC MONOGRAPH FINAL part341 American Sales Company PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 41520-099_3c3473b3-c4d6-424e-82cb-82ac344a30da 41520-099 HUMAN OTC DRUG Sinus Daytime Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121114 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 41520-101_4ac278fe-fa8d-4d5c-88d4-632df32fa1fe 41520-101 HUMAN OTC DRUG Sinus Nighttime Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121031 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 41520-103_1c9f66ad-2cfb-45b9-a205-e8396666983a 41520-103 HUMAN OTC DRUG safety coated aspirin Aspirin TABLET ORAL 20100730 OTC MONOGRAPH NOT FINAL part343 Care One (American Sales Company) ASPIRIN 81 mg/1 N 20181231 41520-104_a09d2e9f-2a50-4daf-ac4b-25118aa69110 41520-104 HUMAN OTC DRUG CAREONE TAHITIAN COCONUT TRICLOSAN LIQUID TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-106_02c27520-0f7b-46d1-8638-7d8fb15129d8 41520-106 HUMAN OTC DRUG CAREONE LIME BASIL TRICLOSAN LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part333E AMERCIAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-107_15148e63-976e-4eb4-835f-bdfb96036d44 41520-107 HUMAN OTC DRUG CAREONE VANILLA BROWN SUGAR TRICLOSAN LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-108_3dab8472-eb60-4cb6-9dcc-294d77dda58c 41520-108 HUMAN OTC DRUG CareOne Severe Congestion Nasal Oxymetazoline hydrochloride SPRAY NASAL 20160831 OTC MONOGRAPH FINAL part341 American Sales Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41520-109_563e5aae-3699-4509-aacf-dc3837da8fe7 41520-109 HUMAN OTC DRUG CareOne Childrens Allergy Diphenhydramine HCl SOLUTION ORAL 20151028 OTC MONOGRAPH FINAL part341 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 41520-110_a0727362-60f6-4aae-8874-a14d990260e9 41520-110 HUMAN OTC DRUG CareOne Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061218 ANDA ANDA076779 American Sales Company NICOTINE 4 mg/1 N 20181231 41520-111_15eda702-b8ea-4d81-a08c-7ad548aa20dd 41520-111 HUMAN OTC DRUG Care One Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 American Sales SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 41520-115_953120bc-5599-411c-9df1-51c3aed63e50 41520-115 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100720 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) DOCUSATE SODIUM 100 mg/1 E 20171231 41520-116_54a91980-4277-40b5-9333-2cd61effa823 41520-116 HUMAN OTC DRUG CARE ONE VANILLA BEAN TRICLOSAN LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-117_4acf757b-4ddc-4916-aa8b-fb811fed8d86 41520-117 HUMAN OTC DRUG CareOne Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120524 ANDA ANDA202319 American Sales Company LANSOPRAZOLE 15 mg/1 N 20181231 41520-118_d2b5480d-facb-4267-b021-298f28d6199d 41520-118 HUMAN OTC DRUG CARE ONE PUMPKIN PIE TRICLOSAN LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-119_e51b56c4-83d8-4cfc-a33c-8961c1d8a4fd 41520-119 HUMAN OTC DRUG CARE ONE PEPPERMINT SWIRL TRICLOSAN LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-120_c2e1f09e-e651-412d-be64-8913eb1147ed 41520-120 HUMAN OTC DRUG gentle laxative for women stimulant laxative Bisacodyl TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) BISACODYL 5 mg/1 N 20181231 41520-121_4f445ea4-2128-42b9-8aec-a30ddeb1c198 41520-121 HUMAN OTC DRUG CARE ONE PINE TRICLOSAN LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-123_34cf9cca-c69f-4d0b-8c44-06945dbd3750 41520-123 HUMAN OTC DRUG CAREONE COUNTRY APPLE TRICLOSAN LIQUID TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-125_bee1996d-dcf7-4dde-a9c2-c2e80700c6ab 41520-125 HUMAN OTC DRUG CAREONE APPLE BERRY TRICLOSAN LIQUID TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-127_d8049d4e-fe5b-43e8-bc97-6587405bc8c7 41520-127 HUMAN OTC DRUG CareOne 8 Hour Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170416 ANDA ANDA075077 American Sales Company ACETAMINOPHEN 650 mg/1 N 20181231 41520-129_935b245a-3cfc-4640-9c1a-0466971776d7 41520-129 HUMAN OTC DRUG All Day Allergy Antihistamine Cetirizine HCl TABLET ORAL 20100907 ANDA ANDA078780 Care One (American Sales Company) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 41520-131_ad575284-9464-4092-908e-8c1fc565d4eb 41520-131 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 American Sales Company LORATADINE 5 mg/5mL N 20181231 41520-138_13f1779c-0156-1d96-e054-00144ff8d46c 41520-138 HUMAN OTC DRUG Cold Multi-Symptom Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110901 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41520-140_2b7d0c93-dce1-45b9-94cb-c3e793b771bc 41520-140 HUMAN OTC DRUG care one all day pain relief Naproxen sodium TABLET, FILM COATED ORAL 20080926 ANDA ANDA074661 American Sales Company NAPROXEN SODIUM 220 mg/1 N 20181231 41520-141_11d463af-fb95-470a-a57c-87004189954b 41520-141 HUMAN OTC DRUG care one acid reducer original strength Famotidine TABLET ORAL 20091009 ANDA ANDA075400 American Sales Company FAMOTIDINE 10 mg/1 N 20181231 41520-142_c1c6ffd2-d811-4874-9143-4970ac17f595 41520-142 HUMAN OTC DRUG Laxative pills maximum strength Sennosides TABLET ORAL 20100805 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) SENNOSIDES 25 mg/1 N 20181231 41520-143_aff16300-6583-4d5a-be2a-511f7944e318 41520-143 HUMAN OTC DRUG CareOne Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20110211 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-145_5fbceec3-24e5-4e3f-83f3-8395977a15b7 41520-145 HUMAN OTC DRUG CareOne Mucus Relief Cold and Sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130823 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 41520-153_baaddc4c-086d-4c16-a308-efaa184c8d8c 41520-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H FOODHOLD U.S.A., LLC PYRITHIONE ZINC 10 mg/mL N 20181231 41520-154_35ae0988-86a1-4282-a01f-159121927fac 41520-154 HUMAN OTC DRUG CareOne Miconazole 3 Miconazole nitrate KIT 20140413 ANDA ANDA075329 American Sales Company N 20181231 41520-157_7b15c5ee-620c-4caa-8f3c-92375f1d7878 41520-157 HUMAN OTC DRUG Aspirin Regular Strength Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 FOODHOLD U.S.A., LLC ASPIRIN 325 mg/1 N 20181231 41520-160_68413266-83fd-4960-9380-10280c9afd44 41520-160 HUMAN OTC DRUG CareOne Hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20130102 OTC MONOGRAPH FINAL part346 American Sales Company COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g N 20181231 41520-161_1dea76ff-ad67-481b-af80-3a2d70836fde 41520-161 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110516 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .46 mL/100mL N 20181231 41520-162_f4360be1-d781-417a-9d5e-5baf9fb98596 41520-162 HUMAN OTC DRUG Lidocaine Burn Relief AEROSOL, SPRAY TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part348 Foodhold USA LIDOCAINE .64 g/127g N 20181231 41520-163_0b70056b-48f2-4386-9307-e1fb657b434c 41520-163 HUMAN OTC DRUG Anticavity Sodium Fluoride MOUTHWASH ORAL 20050912 OTC MONOGRAPH FINAL part355 American Sales Company SODIUM FLUORIDE 1 mg/mL N 20181231 41520-164_46bb3b81-47e9-4d37-8694-cfd525dcc909 41520-164 HUMAN OTC DRUG Salicylic Acid One Step Wart Remover PLASTER TOPICAL 20171219 OTC MONOGRAPH FINAL part358B Foodhold USA SALICYLIC ACID 40 mg/141 N 20181231 41520-165_65605c3c-749a-48fd-a7a8-262f45b64141 41520-165 HUMAN OTC DRUG ANTIBACTERIAL FOAMING GREEN TEA TRICLOSAN LIQUID TOPICAL 20110516 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .46 mL/100mL N 20181231 41520-166_1074cb2a-63b7-4a4c-b382-e9c51f857973 41520-166 HUMAN OTC DRUG care one ibuprofen childrens Ibuprofen SUSPENSION ORAL 20040428 ANDA ANDA074937 American Sales Company IBUPROFEN 100 mg/5mL N 20181231 41520-167_a25acb68-7365-456b-b517-a6745fa64768 41520-167 HUMAN OTC DRUG ANTIBACTERIAL FOAMING HAND SP CUCUMBER AND MELON TRICLOSAN LIQUID TOPICAL 20110524 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .6 mL/100mL N 20181231 41520-168_d59294c7-2de7-4a2c-819e-f1e0fccf3eb0 41520-168 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111006 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .6 mL/100mL N 20181231 41520-169_1af8d91e-b018-466d-86d1-8d19670be829 41520-169 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110516 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .46 mL/100mL N 20181231 41520-170_b0d260e6-b973-4fb5-825f-75f28e0ff93f 41520-170 HUMAN OTC DRUG ANTIBACTERIAL FOAMING OLIVE AND ALOE TRICLOSAN LIQUID TOPICAL 20110121 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .3 mL/100mL N 20181231 41520-170_b6f080b6-4f77-4067-8da1-97bfee9a901e 41520-170 HUMAN OTC DRUG ANTIBACTERIAL FOAMING OLIVE AND ALOE TRICLOSAN LIQUID TOPICAL 20111025 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .3 mL/100mL N 20181231 41520-171_a57be6d4-8a5e-4f92-8758-7e2a9522d3f8 41520-171 HUMAN OTC DRUG ANTIBACTERIAL FOAMING BERRY MEDLEY TRICLOSAN LIQUID TOPICAL 20110121 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .3 mL/100mL N 20181231 41520-172_897f99da-7773-4931-ab00-433de4d9fd25 41520-172 HUMAN OTC DRUG ANTIBACTERIAL FOAMING HAND SP LEMONGRASS TRICLOSAN LIQUID TOPICAL 20110524 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES TRICLOSAN .6 mL/100mL N 20181231 41520-173_aff4c53b-24bd-4b2d-8f47-75a048383e11 41520-173 HUMAN OTC DRUG careone lice Piperonyl Butoxide, Pyrethrum Extract KIT 20070926 OTC MONOGRAPH FINAL part358G American Sales Company N 20181231 41520-173_f0ac01e5-4bd8-4c7c-9e15-9b7addd8e407 41520-173 HUMAN OTC DRUG careone lice Piperonyl Butoxide, Pyrethrum Extract KIT 20070926 OTC MONOGRAPH FINAL part358G American Sales Company N 20181231 41520-175_56eb4917-74dd-4ea3-872b-fd546a914392 41520-175 HUMAN OTC DRUG care one pain relief childrens Acetaminophen SUSPENSION ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-176_559814f0-9a33-4f0c-90d8-75c38fb696d8 41520-176 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140630 OTC MONOGRAPH NOT FINAL part356 Care One (American Sales Company) PHENOL 1.4 g/100mL N 20181231 41520-178_47d2da7d-230b-413c-8267-8408cdc6a95d 41520-178 HUMAN OTC DRUG CAREONE INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 700 mg/mL N 20181231 41520-178_833eefb3-aad7-43c5-a51d-c611f9f697f3 41520-178 HUMAN OTC DRUG CAREONE Instant Hand Sanitizer with Moisturizers and Vitamin E Ethyl Alcohol LIQUID TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 700 mg/mL N 20181231 41520-179_f94d1c14-d0a8-4c76-b7d9-3ff286373235 41520-179 HUMAN OTC DRUG care one calcium antacid Calcium carbonate TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 750 mg/1 N 20181231 41520-180_285855f8-d1f8-485a-b360-faa586015537 41520-180 HUMAN OTC DRUG Senna laxative Natural vegetable laxative SENNOSIDES TABLET ORAL 20130220 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) SENNOSIDES 8.6 mg/1 N 20181231 41520-182_6629cc4f-13d7-4926-8bad-a06d8c06b7a6 41520-182 HUMAN OTC DRUG Senna S docusate sodium and sennosides TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 41520-183_29223c42-bc35-4633-a212-d53d773dfa02 41520-183 HUMAN OTC DRUG ANTIBACTERIAL FOAMING HAND SP CHERRY AND ALMOND TRICLOSAN LIQUID TOPICAL 20110524 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES TRICLOSAN .6 mL/100mL N 20181231 41520-187_ee8e33a7-dd95-41df-bac3-29dfef40ffa7 41520-187 HUMAN OTC DRUG Care One pain relief extra strength Acetaminophen TABLET, COATED ORAL 20031125 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 500 mg/1 N 20181231 41520-188_926691f4-44ae-4a5a-9810-2603e9344f6d 41520-188 HUMAN OTC DRUG careone hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140720 OTC MONOGRAPH FINAL part346 American Sales Company MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 41520-189_975ecee8-52cd-4a3c-a304-8be3a3d24c80 41520-189 HUMAN OTC DRUG CareOne Childrens All Day Allergy Cetirizine HCl LIQUID ORAL 20131227 ANDA ANDA204226 American Sales Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 41520-190_ca40d723-dbc2-4b81-b176-03f1e6f15333 41520-190 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL RUM RAISIN TRICLOSAN LIQUID TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 3 mg/mL N 20181231 41520-191_58455c76-6876-4299-82d7-1f859ad77b84 41520-191 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL TANGERINE SPICE TRICLOSAN LIQUID TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 3 mg/mL N 20181231 41520-192_b4e3c65d-3b02-4099-b0aa-17ab18104bd9 41520-192 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL SNOW KISSED PEAR TRICLOSAN LIQUID TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 3 mg/mL N 20181231 41520-193_23c03d48-9b68-4a1e-bc3b-8229dd2f5d00 41520-193 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL PEPPERMINT SWIRL TRICLOSAN LIQUID TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 3 mg/mL N 20181231 41520-195_04320096-3158-4a58-b801-4cb83f2cce27 41520-195 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130315 ANDA ANDA078682 Care One (American Sales Company) IBUPROFEN 200 mg/1 N 20181231 41520-196_3db799d5-7bcb-4df9-9c02-957d9bc90591 41520-196 HUMAN OTC DRUG CARE ONE CREAMY COCONUT TRICLOSAN LIQUID TOPICAL 20130220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-197_fc1335ea-8a88-4ffb-bac4-9be715b3804c 41520-197 HUMAN OTC DRUG CARE ONE SUN KISSED PEAR TRICLOSAN LIQUID TOPICAL 20130220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-198_c2cd2e41-2c13-4866-b710-c454b6b784e6 41520-198 HUMAN OTC DRUG CARE ONE VANILLA APPLE BLOSSOM TRICLOSAN LIQUID TOPICAL 20130220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-199_0af3dcc2-dbef-4aa2-9298-c90da146dd42 41520-199 HUMAN OTC DRUG CARE ONE LEMON VERBENA TRICLOSAN LIQUID TOPICAL 20130220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN 4.6 mg/mL N 20181231 41520-201_35018f2c-bc48-48b1-9077-618a737d5d75 41520-201 HUMAN OTC DRUG careone hydrocortisone 1 maximum strength hydrocortisone OINTMENT TOPICAL 20121017 OTC MONOGRAPH NOT FINAL part348 American Sales Company HYDROCORTISONE 1 g/100g N 20181231 41520-203_c9776b83-0e14-40c1-8ac4-98521d1648c0 41520-203 HUMAN OTC DRUG careone all day allergy Cetirizine HCl SOLUTION ORAL 20151221 ANDA ANDA204226 American Sales Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 41520-204_3006ac64-b9c6-4e03-a734-b4fe769784bf 41520-204 HUMAN OTC DRUG Anticavity Rinse Sodium Fluoride MOUTHWASH ORAL 20100310 OTC MONOGRAPH FINAL part355 Foodhold U.S.A. LLC SODIUM FLUORIDE .2 mg/mL N 20191231 41520-205_00a5f004-03db-4d53-b63b-cf00d107becc 41520-205 HUMAN OTC DRUG Therapeutic Plus Coal Tar SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H FoodHold U.S.A., LLC COAL TAR 25 mg/mL N 20181231 41520-207_ad330853-100d-4eb4-9b88-d615c5e23ff7 41520-207 HUMAN OTC DRUG CareOne Pain Relief Acetaminophen SUSPENSION ORAL 20110902 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-208_a50a4b40-c72b-4c89-8fac-09f0bcd88ecb 41520-208 HUMAN OTC DRUG CareOne Acetaminophen PM Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20160902 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41520-209_ed1063f8-b500-412d-b76e-00f462faca37 41520-209 HUMAN OTC DRUG CareOne Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20160421 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-210_ca6269c5-59dd-492d-9df3-e2296b855ceb 41520-210 HUMAN OTC DRUG Antiseptic Mouth rinse Eucalyptol MOUTHWASH ORAL 20100802 OTC MONOGRAPH NOT FINAL part348 American Sales Company EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 41520-211_4f4f4ede-056f-4548-819b-8680f151ce83 41520-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20131230 NDA NDA022429 Care One (American Sales Company) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 41520-213_8dbbc90f-10cc-4f95-9d3d-ae49c48598ff 41520-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20100524 OTC MONOGRAPH FINAL part355 American Sales Company SODIUM FLUORIDE .05 kg/100L N 20181231 41520-214_cc63ed76-b8ca-4f7e-9cca-5ff84f66943d 41520-214 HUMAN OTC DRUG care one miconazole 7 Miconazole nitrate CREAM VAGINAL 19991011 ANDA ANDA074760 American Sales Company MICONAZOLE NITRATE 2 g/100g N 20181231 41520-217_4ff54c0e-30d5-4669-8f53-2e030cf06e1b 41520-217 HUMAN OTC DRUG care one pain relief 8 hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051129 ANDA ANDA075077 American Sales Company ACETAMINOPHEN 650 mg/1 N 20181231 41520-218_e54a326b-17f3-46fc-b4d2-661f7c1720f4 41520-218 HUMAN OTC DRUG Clear Anti-Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 20160322 OTC MONOGRAPH NOT FINAL part347 Foodhold U.S.A. LLC PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 1; .1 mg/mL; mg/mL N 20181231 41520-220_a1718e1a-a066-47fd-b6db-d400f5dc9a6b 41520-220 HUMAN OTC DRUG CAREONE ETHYL ALCOHOL LIQUID TOPICAL 20130606 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 620 mg/mL N 20181231 41520-222_712bfb93-e185-45d6-b0a3-094496e6fca8 41520-222 HUMAN OTC DRUG CareOne Miconazole 3 Miconazole nitrate KIT 20161017 ANDA ANDA076357 American Sales Company N 20181231 41520-223_1cc5e2f7-1f6e-4ecb-a7ff-d1a7467bc7a8 41520-223 HUMAN OTC DRUG CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20110114 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 62 mL/100mL N 20181231 41520-223_24f0f587-3a19-4f45-8357-06daca4ef3db 41520-223 HUMAN OTC DRUG CAREONE INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 62 mL/100mL N 20181231 41520-224_639f7cc2-9fe4-43c3-a2bb-04bb528d74af 41520-224 HUMAN OTC DRUG Care One anti diarrheal loperamide hydrochloride Loperamide Hydrochloride TABLET, FILM COATED ORAL 20040123 ANDA ANDA075232 American Sales Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 41520-225_99db10f5-33ec-4b42-a450-7764118a8a3a 41520-225 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 62 mL/100mL N 20181231 41520-226_a96cf809-a48d-4220-ae39-55cbf1066abb 41520-226 HUMAN OTC DRUG Creamy Diaper Rash Zinc Oxide OINTMENT TOPICAL 20110901 OTC MONOGRAPH FINAL part347 American Sales ZINC OXIDE 13 kg/100kg N 20181231 41520-227_a51f78fc-c6dc-43bd-b963-5e62533acbe7 41520-227 HUMAN OTC DRUG CAREONE INSTANT HAND SANITIZER LEMON ETHYL ALCOHOL GEL TOPICAL 20110114 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 62 mL/100mL N 20181231 41520-228_640bee1e-7b8d-46d3-8d4e-80ce6148955a 41520-228 HUMAN OTC DRUG Aspirin Enteric Safety Coated Aspirin TABLET ORAL 20140430 OTC MONOGRAPH FINAL part343 Care One (American Sales Company) ASPIRIN 81 mg/1 N 20181231 41520-229_017c1180-a743-46f3-8656-adafc2083d8c 41520-229 HUMAN OTC DRUG CareOne Allergy Relief fexofenadine hcl TABLET, FILM COATED ORAL 20161014 ANDA ANDA076447 American Sales Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 41520-230_ecc5a12f-507c-4141-af1b-11ad9c6d4211 41520-230 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20111005 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 62 mL/100mL N 20181231 41520-231_0dd1101a-b6bc-4e93-884d-1ce5b9873652 41520-231 HUMAN OTC DRUG Sleep Aid maximum strength Diphenhydramine HCl CAPSULE ORAL 20100701 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 41520-233_43267299-6ecd-2783-e054-00144ff8d46c 41520-233 HUMAN OTC DRUG Sinus and Allergy PE CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110801 OTC MONOGRAPH FINAL part341 American Sales Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 41520-234_3543e9f8-cc31-4314-a30a-e32499e74bce 41520-234 HUMAN OTC DRUG Care One cold head congestion Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20081024 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41520-235_a4035454-bf60-471d-b580-68071fc3bb5c 41520-235 HUMAN OTC DRUG SANITIZER HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20110506 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES ALCOHOL 62 mL/100mL N 20181231 41520-236_9763a855-4c13-4b36-bfe9-ef26254baad3 41520-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 41520-238_40d5541c-f189-4811-8e51-0bbe88bd5142 41520-238 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130708 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) DOCUSATE SODIUM 100 mg/1 N 20181231 41520-240_36893d28-9257-46f2-aa6d-7ea6ce3e324c 41520-240 HUMAN OTC DRUG FOAMING HAND SANITIZER WITH ALOE BENZALKONIUM CHLORIDE GEL TOPICAL 20111006 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 41520-241_286c994c-9d23-458a-933d-5d1bf760842a 41520-241 HUMAN OTC DRUG CAREONE ANTIMICROBIAL FOAMING HAND SP FALLING RAIN BENZETHONIUM CHLORIDE LIQUID TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY BENZETHONIUM CHLORIDE .1 mL/100mL N 20181231 41520-242_599b8a3a-c320-46a3-9590-7317652f4fc0 41520-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131115 OTC MONOGRAPH FINAL part347 Care One (American Sales Company) DIMETHICONE 125 mg/1 N 20181231 41520-244_d4d2cb3a-8a12-426b-bfee-7f43b6b35ea9 41520-244 HUMAN OTC DRUG Stool Softener Gentle Relief DOCUSATE SODIUM CAPSULE ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) DOCUSATE SODIUM 100 mg/1 N 20181231 41520-248_192c3b1f-80e6-4839-8d67-e73e56d71924 41520-248 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090112 OTC MONOGRAPH FINAL part341 FoodHold U.S.A., LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/g; kg/g; kg/g N 20181231 41520-252_d761ce3e-5a9d-43ef-ad95-b1a3d8326c5c 41520-252 HUMAN OTC DRUG Drowz Away Maximum strength Caffeine TABLET ORAL 20100831 OTC MONOGRAPH FINAL part340 Care One (American Sales Company) CAFFEINE 200 mg/1 N 20181231 41520-255_c4b2be11-e5e3-4b8e-87dc-3461f656956a 41520-255 HUMAN OTC DRUG care one ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20060516 ANDA ANDA075217 American Sales Company IBUPROFEN 50 mg/1.25mL N 20191231 41520-259_cf4568d3-d25a-4567-b8b7-93349833cb04 41520-259 HUMAN OTC DRUG care one aspirin Aspirin TABLET, CHEWABLE ORAL 20051122 OTC MONOGRAPH NOT FINAL part343 American Sales Company ASPIRIN 81 mg/1 N 20181231 41520-270_ad75f989-6985-4b4d-809b-72b22677f238 41520-270 HUMAN OTC DRUG Sinus Headache PE Non- Drowsy Maximum Strength Acetaminophen and Phenylephrine HCl TABLET ORAL 20140612 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 41520-272_96be2ba6-23e8-441c-a00f-e3f870a19afd 41520-272 HUMAN OTC DRUG care one sinus congestion and pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070207 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 41520-274_34b5de46-75e7-41ce-8166-529329a3f250 41520-274 HUMAN OTC DRUG careone aspirin Aspirin TABLET, CHEWABLE ORAL 20171009 OTC MONOGRAPH NOT FINAL part343 American Sales Company ASPIRIN 81 mg/1 N 20181231 41520-279_aa788c6c-481d-478c-8216-45a7ad7b8147 41520-279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part333A Foodhold U.S.A. BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 41520-280_d5c6ed63-74af-4354-a64a-ea6d883a6ac3 41520-280 HUMAN OTC DRUG HAND SANITIZER BENZALKONIUM CHLORIDE GEL TOPICAL 20111006 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 41520-281_5bb51652-ea78-4727-91c3-2e94e7cc4abe 41520-281 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110622 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .15 mL/100mL N 20181231 41520-282_bc2f5094-0d8b-43a0-aae7-713651df52b1 41520-282 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110622 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .15 mL/100mL N 20181231 41520-283_cdc6cd57-b88d-43d4-a1b2-640c109e694b 41520-283 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110622 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .15 mL/100mL N 20181231 41520-288_04f5e6fe-2ee0-4740-8fde-9f58ce00d032 41520-288 HUMAN OTC DRUG careone mucus relief childrens Guaifenesin SOLUTION ORAL 20070808 OTC MONOGRAPH FINAL part341 American Sales Company GUAIFENESIN 100 mg/5mL N 20181231 41520-293_084b5ccb-cd0b-4afe-937f-609808367609 41520-293 HUMAN OTC DRUG ANTIBACTERIAL MANDARIN AND POMELO TRICLOSAN LIQUID TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY TRICLOSAN .15 mL/100mL N 20181231 41520-294_f4ba4490-4c67-4892-8a12-be2dd8860431 41520-294 HUMAN OTC DRUG careone hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20120727 ANDA ANDA091344 American Sales Company MINOXIDIL 5 g/100g N 20181231 41520-295_9c5e2c8f-3591-422c-9576-2edad27c24b8 41520-295 HUMAN OTC DRUG Itch Relief Diphenhydramine HCl, Zinc Acetate SPRAY TOPICAL 20111006 OTC MONOGRAPH NOT FINAL part348 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 kg/100L; kg/100L N 20181231 41520-296_aad39712-3070-45d3-8d5a-b1dffc6595b1 41520-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20090605 OTC MONOGRAPH FINAL part358H FOODHOLD U.S.A. LLC PYRITHIONE ZINC 10 mg/mL N 20181231 41520-297_0a294e82-6d85-4d9e-b70c-5c760e785fcc 41520-297 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide SUSPENSION ORAL 20150930 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 41520-301_1b6cc841-4566-458f-bf44-8add8a2b0a1e 41520-301 HUMAN OTC DRUG careone childrens allergy relief Cetirizine HCl SOLUTION ORAL 20160406 ANDA ANDA204226 American Sales Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 41520-302_eb2f7cdc-ebd9-401e-8936-50ede358d5bf 41520-302 HUMAN OTC DRUG careone stomach relief Bismuth subsalicylate SUSPENSION ORAL 20120805 OTC MONOGRAPH FINAL part335 American Sales Company BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 41520-304_68c15e91-194f-458a-9fca-c873f2330d08 41520-304 HUMAN OTC DRUG care one nasal original oxymetazoline hydrochloride SPRAY NASAL 20040524 OTC MONOGRAPH FINAL part341 American Sales Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41520-305_9e0e3507-73d5-4f52-bd31-6f2448102d26 41520-305 HUMAN OTC DRUG CAREONE Clotrimazole Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C American Sales Company CLOTRIMAZOLE 10 mg/g N 20181231 41520-306_1fc93b7c-85b9-45f9-87f3-f8345b5b988a 41520-306 HUMAN OTC DRUG care one clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091009 ANDA ANDA090685 American Sales Company POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 41520-308_d9fbbdd0-6a4f-4a1d-9447-c95ad57488c9 41520-308 HUMAN OTC DRUG Cough Relief Dextromethorphan HBr LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 41520-309_0d13a818-a8c2-4387-9849-274f3180b775 41520-309 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20110210 OTC MONOGRAPH FINAL part358H American Sales Company PYRITHIONE ZINC 1 g/100mL N 20181231 41520-310_146f99de-a90d-46dd-9e4f-5388dc8a13c3 41520-310 HUMAN OTC DRUG CareOne Adult Tussin Guaifenesin SOLUTION ORAL 20040504 OTC MONOGRAPH FINAL part341 American Sales Company GUAIFENESIN 200 mg/10mL N 20181231 41520-311_0763aa4a-3a5e-4999-862f-2f4725efc3b7 41520-311 HUMAN OTC DRUG Dandruff Pyrithione zinc LOTION/SHAMPOO TOPICAL 20040709 OTC MONOGRAPH FINAL part358H American Sales Company PYRITHIONE ZINC 10 mg/mL N 20181231 41520-312_c3b3f5b0-0b38-4747-942a-9c0e003fb93d 41520-312 HUMAN OTC DRUG Careone Original Strength Triple Antibiotic Bacitracin Neomycin Polymyxin B OINTMENT TOPICAL 20140916 OTC MONOGRAPH FINAL part333B Foodhold U.S.A. LLC BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 50000 [iU]/g; mg/g; [iU]/g N 20181231 41520-313_c4245a01-9b7b-4c89-a3dc-7db146e78a9c 41520-313 HUMAN OTC DRUG CAREONE BACITRACIN BACITRACIN OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part333B AMERICAN SALES COMPANY BACITRACIN 500 [USP'U]/g N 20181231 41520-314_719fb165-13e9-4067-b800-81854d47ab07 41520-314 HUMAN OTC DRUG CAREONE ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 AMERICAN SALES COMPANY DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 41520-315_37923b58-3b5f-46fb-9fde-75abe933df75 41520-315 HUMAN OTC DRUG Care One Maximum Strength First Aid Antibiotic Neomycin Sulfate Polymyxin B Sulfate Pramoxine Hydrochloride CREAM TOPICAL 20140908 OTC MONOGRAPH FINAL part333B Foodhold U.S.A. LLC NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g N 20181231 41520-318_687f0681-faf0-44e7-af88-b267ede7574b 41520-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19890313 OTC MONOGRAPH NOT FINAL part356 American Sales Company EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41520-319_847c6711-55a7-4a78-8663-6659801222fc 41520-319 HUMAN OTC DRUG Care One hydrocortisone maximum strength Hydrocortisone CREAM TOPICAL 20100528 OTC MONOGRAPH NOT FINAL part348 American Sales Company HYDROCORTISONE 1 g/100g N 20181231 41520-321_6888fc65-e088-4d96-add2-bbdeca29b3b5 41520-321 HUMAN OTC DRUG Care One Acid Reducer plus Antacid Dual Action Famotidine, Calcium Carbonate,Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080801 ANDA ANDA077355 American Sales Company FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 41520-323_94603458-c822-448b-8b77-7ed2c4ef7ad2 41520-323 HUMAN OTC DRUG CareOne Lubricant Eye Plus carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20130620 OTC MONOGRAPH FINAL part349 American Sales Company CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM .5 g/100mL N 20181231 41520-325_95b0bac7-228d-4166-907a-dcd592208a9a 41520-325 HUMAN OTC DRUG CareOne Mucus Relief ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160819 ANDA ANDA091009 American Sales Company GUAIFENESIN 1200 mg/1 N 20181231 41520-326_b00fa6e5-86b0-4c33-bd83-b06826a0cc22 41520-326 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150531 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 41520-329_ea355212-ae28-4b8c-a046-364f6e41ad0b 41520-329 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150531 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 41520-330_28c5c8b5-5939-3be0-e054-00144ff88e88 41520-330 HUMAN OTC DRUG CareOne Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20130731 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 41520-332_0fd85633-3eaf-4f4b-bb51-21a8c51a7909 41520-332 HUMAN OTC DRUG careone milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20120727 OTC MONOGRAPH NOT FINAL part334 American Sales Company MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 41520-333_220a48c3-2d87-4b82-8c41-caec5c77bc81 41520-333 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 American Sales Company ACETAMINOPHEN 650 mg/1 N 20181231 41520-334_1fbc586c-9adf-4494-9ee3-a7441183d5e0 41520-334 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20161130 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) MINERAL OIL 100 mg/100mL N 20181231 41520-335_911fdf0b-c30e-49e2-9311-8813dc2857a4 41520-335 HUMAN OTC DRUG CareOne Nitetime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20130813 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 41520-336_a833a491-7e96-4c0e-b534-38f757335f9e 41520-336 HUMAN OTC DRUG Acetaminophen-APAP 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 American Sales Company ACETAMINOPHEN 650 mg/1 N 20181231 41520-337_6dc557de-2a58-4eab-be6e-91204cde23de 41520-337 HUMAN OTC DRUG careone stomach relief Bismuth subsalicylate SUSPENSION ORAL 20120805 OTC MONOGRAPH FINAL part335 American Sales Company BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 41520-339_a9c4e1a8-b7d9-4d2f-8a70-5d3b9d96a4c1 41520-339 HUMAN OTC DRUG CareOne Lice Solution Piperonyl butoxide, pyrethrum extract KIT 20160429 OTC MONOGRAPH FINAL part358G American Sales Company N 20181231 41520-340_221825cd-4b71-4d97-ab9a-848552885f84 41520-340 HUMAN OTC DRUG careone liquid antacid aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 20120927 OTC MONOGRAPH FINAL part331 American Sales Company ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 41520-341_e5c46712-ee67-4760-84b4-818488718644 41520-341 HUMAN OTC DRUG COTTONTAILS DIAPER RASH LANOLIN, PETROLATUM PASTE TOPICAL 20131216 OTC MONOGRAPH FINAL part347 AMERICAN SALES COMPANY LANOLIN; PETROLATUM 155; 534 mg/g; mg/g N 20181231 41520-343_d7d1e9e7-2bcc-4e74-9007-80d9fb3adee2 41520-343 HUMAN OTC DRUG COTTONTAILS DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20120501 OTC MONOGRAPH FINAL part347 AMERICAN SALES ZINC OXIDE .4 g/g E 20171231 41520-344_484c2d63-b12c-4477-9f75-661dde6ec559 41520-344 HUMAN OTC DRUG Anticavity Rinse Fluoride Rinse Anticavity Rinse MOUTHWASH ORAL 20090905 OTC MONOGRAPH FINAL part355 American Sales Company SODIUM FLUORIDE .0221 kg/100L N 20181231 41520-349_02c5d59d-0d96-48d5-b633-ec6bddfdd958 41520-349 HUMAN OTC DRUG Care One Naproxen Sodium Naproxen sodium TABLET, FILM COATED ORAL 20160613 ANDA ANDA074661 American Sales Company NAPROXEN SODIUM 220 mg/1 N 20181231 41520-352_ca20568a-6954-4df7-baa4-25e5c4823658 41520-352 HUMAN OTC DRUG care one nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20080829 ANDA ANDA078547 American Sales Company NICOTINE 2 mg/1 N 20181231 41520-355_fb283e58-5b0d-470a-9062-77ef2f65cddd 41520-355 HUMAN OTC DRUG CareOne All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080512 ANDA ANDA077170 American Sales Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 41520-357_99b2eee5-3143-450b-9b48-7104fa5651e4 41520-357 HUMAN OTC DRUG careone antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20121118 OTC MONOGRAPH FINAL part331 American Sales Company ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 41520-361_2ad77aa7-cac7-493b-9f12-910f54fd58b9 41520-361 HUMAN OTC DRUG CareOne Allergy Medication Diphenhydramine Hydrochloride TABLET ORAL 20040524 OTC MONOGRAPH FINAL part341 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41520-363_06feee51-0b11-4d46-83cc-5eccaf7346c2 41520-363 HUMAN OTC DRUG CareOne Infants Acetaminophen Acetaminophen SUSPENSION ORAL 20161214 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-365_942cf491-dc3d-49c2-ad83-1a579b7d3c2e 41520-365 HUMAN OTC DRUG careone nicotine polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20120922 ANDA ANDA091349 American Sales Company NICOTINE 2 mg/1 N 20181231 41520-368_9d588aa4-5175-4d23-9f6b-25703efef4d6 41520-368 HUMAN OTC DRUG care one all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20040405 ANDA ANDA074661 American Sales Company NAPROXEN SODIUM 220 mg/1 N 20181231 41520-370_f703b665-db5c-472e-be55-2898976cc244 41520-370 HUMAN OTC DRUG aspirin Regular strength Aspirin TABLET, COATED ORAL 20110802 OTC MONOGRAPH FINAL part343 Care One (American Sales Company) ASPIRIN 325 mg/1 N 20181231 41520-374_7c2c6e26-7f1d-4985-a200-1ad571cf897f 41520-374 HUMAN OTC DRUG Care One migraine relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20040413 ANDA ANDA075794 American Sales Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 41520-376_cf7972bf-c8c3-495b-8f98-86954808e7a5 41520-376 HUMAN OTC DRUG CareOne Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-377_c3c7ddc6-05a4-42d0-bfa9-db98ff32ea5a 41520-377 HUMAN OTC DRUG Sore Throat Menthol Phenol SPRAY ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 Care One (American Sales Company) PHENOL 1.4 g/100mL N 20181231 41520-378_91aa186a-6c6c-47f7-905e-d0011f3e4e2b 41520-378 HUMAN OTC DRUG Triacting Day Time Cold and Cough Childrens Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 41520-379_38a16a28-9baa-42a8-8d29-244662601e7c 41520-379 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20120110 OTC MONOGRAPH NOT FINAL part348 Foodhold U.S.A. LLC MENTHOL 1.5 mg/g N 20181231 41520-381_319d5a01-e2b0-4c95-bf56-edac41a95f8c 41520-381 HUMAN OTC DRUG CareOne Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130823 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41520-383_e7d5db3e-1cc4-4e49-9a61-52fb7baeba46 41520-383 HUMAN OTC DRUG Tussin Cough Long Acting Dextromethorphan HBr LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL N 20181231 41520-384_be7ee945-e06a-434e-ad15-30e6d16591c4 41520-384 HUMAN OTC DRUG CareOne Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120830 ANDA ANDA091135 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 41520-385_45f8f2db-c1fb-4d8c-a72a-5112e1ac3e95 41520-385 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 41520-388_a8d90458-563e-4182-96d2-868865f906ea 41520-388 HUMAN OTC DRUG CARE ONE NASAL Oxymetazoline HCl SPRAY NASAL 20040720 OTC MONOGRAPH FINAL part341 American Sales Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41520-390_b45eb1ac-b3fa-464c-9b16-e2df7bcd0df1 41520-390 HUMAN OTC DRUG care one nose drops Phenylephrine hydrochloride LIQUID NASAL 20040601 OTC MONOGRAPH FINAL part341 American Sales Company PHENYLEPHRINE HYDROCHLORIDE 1 mL/100mL N 20181231 41520-392_c94ca145-9bde-417a-babe-e4f773ef73ac 41520-392 HUMAN OTC DRUG CareOne Acid Relief Ranitidine TABLET, FILM COATED ORAL 20160601 ANDA ANDA091429 American Sales Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 41520-396_c7498a9e-0dac-4414-b422-7119a1bebc18 41520-396 HUMAN OTC DRUG careone milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20120805 OTC MONOGRAPH NOT FINAL part334 American Sales Company MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 41520-397_8115da6a-5122-4fe4-a064-7a2447c2d9e7 41520-397 HUMAN OTC DRUG careone childrens pain and fever acetaminophen SUSPENSION ORAL 20120821 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-399_d9ac6254-48f0-4426-bbe1-3eea618f94d3 41520-399 HUMAN OTC DRUG careone infants pain relief acetaminophen SUSPENSION ORAL 20140327 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-401_8ec60879-f4d4-45f1-8239-013c709bd1ce 41520-401 HUMAN OTC DRUG CAREONE TAHITIAN COCONUT ETHYL ALCOHOL LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-401_910f6d88-f1a6-422e-b2b8-7ad8bfc2ba1a 41520-401 HUMAN OTC DRUG CAREONE TAHITIAN COCONUT ETHYL ALCOHOL LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-404_9cbbf39a-48d1-43da-bc34-9573136f9b8b 41520-404 HUMAN OTC DRUG CareOne Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-407_4d1ca466-b6db-4257-ae97-8d2e67ac5a88 41520-407 HUMAN OTC DRUG CareOne Cold Sore Treatment Camphor CREAM TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part348 American Sales Company BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 41520-409_5d4bea42-25d5-4943-b5ed-471eccd36bf8 41520-409 HUMAN OTC DRUG CareOne Acid Reducer Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160929 ANDA ANDA077355 American Sales Company FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 41520-410_3135acba-666a-4faa-8360-0644e15e687d 41520-410 HUMAN OTC DRUG CAREONE COUNTRY APPLE ETHYL ALCOHOL LIQUID TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-410_a5c0ca09-8eb0-456f-92c5-857b95553597 41520-410 HUMAN OTC DRUG CAREONE COUNTRY APPLE ETHYL ALCOHOL LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-410_b88957ae-1522-4a82-b8ce-c7bfb3f223c5 41520-410 HUMAN OTC DRUG CareOne Country Apple Ethyl Alcohol LIQUID TOPICAL 20170516 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 650 mg/mL N 20181231 41520-411_37091932-e5e7-4412-b7dc-aef5cde6f03d 41520-411 HUMAN OTC DRUG CAREONE Antibacterial Sanitizer Limoncello Ethyl Alcohol LIQUID TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 650 mg/mL N 20181231 41520-411_9c5efc35-0044-4a38-92b1-034506c9cdb0 41520-411 HUMAN OTC DRUG CAREONE ANTIBACTERIAL SANITIZER LIMONCELLO ETHYL ALCOHOL LIQUID TOPICAL 20150303 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-412_e23706e3-888d-4637-a546-fc60c4d3edc0 41520-412 HUMAN OTC DRUG CAREONE Antibacterial Sanitizer Fresh Water Ethyl Alcohol LIQUID TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 650 mg/mL N 20181231 41520-412_e78fc591-76d1-4311-9379-705825cb56bb 41520-412 HUMAN OTC DRUG CAREONE ANTIBACTERIAL SANITIZER FRESH WATER ETHYL ALCOHOL LIQUID TOPICAL 20150303 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-413_c74cec13-c7b3-4ea0-9b67-8a3708f78b3b 41520-413 HUMAN OTC DRUG careone ibuprofen pm Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20111208 ANDA ANDA079113 American Sales Company DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 41520-414_2776ac77-fd9c-4885-8be9-38414f0a782d 41520-414 HUMAN OTC DRUG CAREONE ANTIBACTERIAL SANITIZER GINGERBREAD HOUSE ETHYL ALCOHOL LIQUID TOPICAL 20150622 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-415_a4bf4237-b53b-41e9-b8d3-2e53360f05d7 41520-415 HUMAN OTC DRUG Care One Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 American Sales SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 41520-417_5819a845-1a11-4e16-8e3a-81710c41ca75 41520-417 HUMAN OTC DRUG CAREONE ANTIBACTERIAL HAND SANITIZER MISTLETOE KISSES ETHYL ALCOHOL LIQUID TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-418_12b6b69b-0700-413b-aa7e-57858bab2b29 41520-418 HUMAN OTC DRUG Skin Corrective Innovative Skin Perfector BB Broad Spectrum SPF15 Sunscreen Light Medium Titanium Dioxide, Octinoxate CREAM TOPICAL 20131113 OTC MONOGRAPH NOT FINAL part352 American Sales Company TITANIUM DIOXIDE; OCTINOXATE 2.1; 4 g/100mL; g/100mL N 20181231 41520-419_82fda1f8-4090-407c-b0c6-7c56e38890b8 41520-419 HUMAN OTC DRUG careone childrens mucus relief Dextromethorphan hbr, Guaifenesin SOLUTION ORAL 20070808 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 41520-420_43930494-df6d-4c7c-a4dd-d6fdd00aeb6c 41520-420 HUMAN OTC DRUG CAREONE ANTIBACTERIAL SANITIZER PEPPERMINT CANDY ETHYL ALCOHOL LIQUID TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-421_9cc3546b-662e-41dc-a556-24d71e71aced 41520-421 HUMAN OTC DRUG CAREONE ANTIBACTERIAL SANITIZER PECAN PUMPKIN PIE ETHYL ALCOHOL LIQUID TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-423_35bbb6a3-c3bd-4790-91f1-faa0fb759a3e 41520-423 HUMAN OTC DRUG CAREONE LIME BASIL ETHYL ALCOHOL LIQUID TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-423_77e52e54-1da8-46fb-87b5-ccaa0f8062d0 41520-423 HUMAN OTC DRUG CAREONE LIME BASIL ETHYL ALCOHOL LIQUID TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-424_ccb9fea3-1e2d-4146-a108-8dbe72d34312 41520-424 HUMAN OTC DRUG CAREONE APPLE BERRY ETHYL ALCOHOL LIQUID TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-425_8b8b6836-da50-46e9-a7d8-19a4e2fb1671 41520-425 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20150131 OTC MONOGRAPH FINAL part335 Care One (American Sales Company) BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 41520-426_78139c20-6258-4da6-abd3-9ba5e5899fd9 41520-426 HUMAN OTC DRUG CareOne Tioconazole 1 Tioconazole OINTMENT VAGINAL 20080107 ANDA ANDA075915 American Sales Company TIOCONAZOLE 6.5 g/100g N 20181231 41520-427_22964383-80f3-4ac6-ae30-793427ec3a17 41520-427 HUMAN OTC DRUG CareOne Daytime Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20161102 OTC MONOGRAPH FINAL part341 American Sales Company N 20181231 41520-428_a2f5a33c-9389-4fac-a470-89b089591e89 41520-428 HUMAN OTC DRUG careone gas relief Simethicone CAPSULE, LIQUID FILLED ORAL 20171102 OTC MONOGRAPH FINAL part332 American Sales Company DIMETHICONE 125 mg/1 N 20181231 41520-429_4d029cac-77b4-42b8-ab8e-d352c5293d31 41520-429 HUMAN OTC DRUG CareOne Nasal and Sinus Decongestant Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160915 ANDA ANDA075153 American Sales Company PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 41520-431_5c0c3948-d0b8-4090-a228-018108073e9c 41520-431 HUMAN OTC DRUG careone nighttime sleep aid Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20040413 OTC MONOGRAPH FINAL part338 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41520-432_2eacc903-5731-4b79-b552-dd7626bdd928 41520-432 HUMAN OTC DRUG Care One Suphedrine Nasal Decongestant Non Drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 20031201 OTC MONOGRAPH FINAL part341 American Sales Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 41520-434_cd8008a6-3a99-49d8-aded-66c3390a16ba 41520-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130906 OTC MONOGRAPH NOT FINAL part356 Foodhold U.S.A., LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41520-435_75d34b9e-d726-49e4-a56d-3fa2502c5bc9 41520-435 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20150601 OTC MONOGRAPH FINAL part355 Foodhold U.S.As., LLC SODIUM FLUORIDE .2 mg/mL N 20181231 41520-437_75831d69-07f4-452c-96d8-15917921027b 41520-437 HUMAN OTC DRUG care one pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41520-440_8d5bd0bf-1627-4102-be0f-355230c3104f 41520-440 HUMAN OTC DRUG Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20100715 OTC MONOGRAPH FINAL part343 Care One (American Sales Company) ASPIRIN 81 mg/1 N 20181231 41520-441_13e80c82-b845-4c2e-945d-a0b7473893e6 41520-441 HUMAN OTC DRUG CARE ONE SLEEP AID Doxylamine succinate TABLET ORAL 20040629 ANDA ANDA040167 American Sales Company DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 41520-443_80764772-88be-4170-b692-944bf6de00fa 41520-443 HUMAN OTC DRUG CareOne Allergy Relief Triamcinolone acetonide SPRAY, METERED NASAL 20170612 ANDA ANDA078104 American Sales Company TRIAMCINOLONE ACETONIDE 55 ug/1 N 20191231 41520-445_cf37cb58-14bc-41a5-9938-448420066a16 41520-445 HUMAN OTC DRUG Nitetime Cold Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130603 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 41520-446_5a08a62c-3472-4ef6-8564-b680594fd6c6 41520-446 HUMAN OTC DRUG DayTime NiteTime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate KIT ORAL 20141030 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) N 20181231 41520-454_4cb89386-6a34-4603-97c4-1677601096c1 41520-454 HUMAN OTC DRUG Childrens Cough Relief Dextromethorphan HBr LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 41520-456_5a96cd27-816b-4e1c-882a-77fd7f7ea519 41520-456 HUMAN OTC DRUG Care One Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061212 ANDA ANDA076777 American Sales Company NICOTINE 2 mg/1 N 20181231 41520-458_aaf2c4cf-43dd-4d28-bc11-dc69559de8a8 41520-458 HUMAN OTC DRUG CareOne All Day Allergy Cetirizine Hydrochloride TABLET ORAL 20080123 ANDA ANDA078336 American Sales Company CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 41520-459_dea8fbd8-23ab-454c-97d7-2f5cd5e5f091 41520-459 HUMAN OTC DRUG CareOne Nitetime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20130807 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 41520-460_e6dcce87-a3c8-42c6-bcd1-0ec214f38e4e 41520-460 HUMAN OTC DRUG careone severe sinus congestion and pain Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20140829 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 41520-462_373b2274-bbff-429f-b2b7-6b427bc3d03a 41520-462 HUMAN OTC DRUG careone allergy diphenhydramine HCl CAPSULE ORAL 20040727 OTC MONOGRAPH FINAL part341 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41520-463_6bdb46fa-81c0-49f0-bda7-01931b840b43 41520-463 HUMAN OTC DRUG careone allergy relief Chlorpheniramine Maleate TABLET ORAL 20040518 OTC MONOGRAPH FINAL part341 American Sales Company CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 41520-467_12e85a44-224a-4d57-a671-ef50d832dd14 41520-467 HUMAN OTC DRUG care one aspirin Aspirin TABLET, CHEWABLE ORAL 20040601 OTC MONOGRAPH NOT FINAL part343 American Sales Company ASPIRIN 81 mg/1 N 20181231 41520-468_b59a42a1-f485-48dc-8296-a3e052283a91 41520-468 HUMAN OTC DRUG care one calcium antacid Calcium carbonate TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 750 mg/1 N 20181231 41520-469_8c4193a3-a200-4c78-aafc-7a0b702c09c9 41520-469 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL RUM RAISIN ETHYL ALCOHOL LIPSTICK TOPICAL 20120925 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 65 mL/100mL N 20181231 41520-470_5844de03-3961-49b5-b991-550e4e617390 41520-470 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL TANGERINE SPICE ETHYL ALCOHOL LIQUID TOPICAL 20120925 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-471_61ba017f-3381-4e42-8374-8e297a6b0ba4 41520-471 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL SNOW KISSED PEAR ETHYL ALCOHOL LIQUID TOPICAL 20120926 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-472_d3ea9052-d071-485a-8aca-998e42896582 41520-472 HUMAN OTC DRUG CARE ONE ANTIBACTERIAL PEPPERMINT SWIRL ETHYL ALCOHOL LIQUID TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-473_1d8c5416-7f2f-4389-b10d-e5e5445b9a1f 41520-473 HUMAN OTC DRUG DAYTIME cold and flu relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20121115 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41520-474_f30495a7-6931-46ce-b3c6-af50de8352b2 41520-474 HUMAN OTC DRUG CARE ONE SUN KISSED PEAR ETHYL ALCOHOL LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-474_f737bfa1-8d06-43ea-883d-57d43f9dfc64 41520-474 HUMAN OTC DRUG CARE ONE SUN KISSED PEAR ETHYL ALCOHOL LIQUID TOPICAL 20130206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-475_90504d49-e099-48f5-8079-c0ac2af40ca6 41520-475 HUMAN OTC DRUG CARE ONE CREAMY COCONUT ETHYL ALCOHOL LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-475_93010594-1d5e-4b69-a967-2ac9515ef8a4 41520-475 HUMAN OTC DRUG CARE ONE CREAMY COCONUT ETHYL ALCOHOL LIQUID TOPICAL 20130206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-476_7fdde583-18d4-4971-8737-cdca25bfa8e3 41520-476 HUMAN OTC DRUG CARE ONE VANILLA APPLE BLOSSOM ETHYL ALCOHOL LIQUID TOPICAL 20130206 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-476_8d3c522d-d70e-48b2-9579-eecb32251d9d 41520-476 HUMAN OTC DRUG CARE ONE VANILLA APPLE BLOSSOM ETHYL ALCOHOL LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-478_aa186ba3-a7a0-4436-bf8d-1e59f8c2135a 41520-478 HUMAN OTC DRUG care one calcium antacid calcium carbonate TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 500 mg/1 N 20181231 41520-479_8b9ae1fb-9a3a-460c-88b0-575803eb5648 41520-479 HUMAN OTC DRUG CARE ONE LEMON VERBENA ETHYL ALCOHOL LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-480_a4610e66-111f-4ec1-a1d2-27e49d17e8b0 41520-480 HUMAN OTC DRUG Nitetime cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120801 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 41520-482_4c37183d-5f08-4828-99b5-0478fe69a8ad 41520-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20130201 OTC MONOGRAPH FINAL part355 American Sales Company SODIUM FLUORIDE 219 mg/mL N 20181231 41520-484_157c6ef8-7f42-4a67-8e4c-5befd188a224 41520-484 HUMAN OTC DRUG Care One pain relief extra strength Acetaminophen TABLET ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 500 mg/1 N 20181231 41520-485_635f97e4-df2e-4284-ac88-cb268717bb18 41520-485 HUMAN OTC DRUG Care One Calcium Antacid calcium carbonate TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 500 mg/1 N 20181231 41520-486_d89d8600-3d15-4000-8fca-ab33d06792ae 41520-486 HUMAN OTC DRUG Senna laxative Sennosides TABLET ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) SENNOSIDES 8.6 mg/1 N 20181231 41520-487_91dbe55f-8ae8-4612-b370-a07a1fc0290e 41520-487 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20161130 OTC MONOGRAPH FINAL part347 Care One (American Sales Company) DIMETHICONE 125 mg/1 N 20191231 41520-489_ba8e2f11-3e08-40b9-a2bd-a777b72d2784 41520-489 HUMAN OTC DRUG care one calcium antacid Calcium carbonate TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 750 mg/1 N 20181231 41520-490_00525800-a7c5-421e-bf50-f8482d1082fe 41520-490 HUMAN OTC DRUG care one all day pain relief Naproxen Sodium TABLET ORAL 20040504 ANDA ANDA074661 American Sales Company NAPROXEN SODIUM 220 mg/1 N 20181231 41520-491_330c32e4-d938-44eb-af2d-f1f6e132d91b 41520-491 HUMAN OTC DRUG DayTime Nitetime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120814 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) N 20181231 41520-492_3734310a-fe05-407b-b4fa-be46ff508ebb 41520-492 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20160531 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) SENNOSIDES 25 mg/1 N 20181231 41520-493_6d7cc8a8-398f-4339-ae19-c93b60dda13c 41520-493 HUMAN OTC DRUG CareOne Sinus plus Headache Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20160915 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 41520-495_39e2d77f-3521-4703-b3b5-6d2dea120dcc 41520-495 HUMAN OTC DRUG CareOne Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20160720 ANDA ANDA077349 American Sales Company IBUPROFEN 200 mg/1 N 20181231 41520-496_004ad4e4-b39c-4689-95f5-015d4d955ee9 41520-496 HUMAN OTC DRUG CARE ONE PUMPKIN PIE ETHYL ALCOHOL LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-497_6647ccde-389f-4033-bb5d-2710b6004e3b 41520-497 HUMAN OTC DRUG CARE ONE PEPPERMINT SWIRL ETHYL ALCOHOL LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-498_91d94af9-ab6a-4e3b-9b6e-8462cbf1ae30 41520-498 HUMAN OTC DRUG CareOne Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130421 ANDA ANDA078912 American Sales Company GUAIFENESIN 600 mg/1 N 20181231 41520-499_676285cb-90a5-4431-b8e1-4338ce869093 41520-499 HUMAN OTC DRUG CARE ONE PINE ETHYL ALCOHOL LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-500_53852fee-c7cd-46f2-b78a-875e608593fd 41520-500 HUMAN OTC DRUG CARE ONE VANILLA BEAN ETHYL ALCOHOL LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-501_ee7e69b9-c9f7-4f49-8e7e-a4d172de3fc7 41520-501 HUMAN OTC DRUG CAREONE ANTIBACTERIAL HAND SANITIZER PUMPKIN ROLL ETHYL ALCOHOL LIQUID TOPICAL 20140814 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-502_9ed3bc24-3104-4e3f-b3d2-8e780675711b 41520-502 HUMAN OTC DRUG CAREONE ANTIBACTERIAL HAND SANITIZER FESTIVAL OF LIGHTS ETHYL ALCOHOL LIQUID TOPICAL 20140814 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-503_a1687dcc-957f-4b2c-82f4-4050b3e85780 41520-503 HUMAN OTC DRUG CAREONE ANTIBACTERIAL HAND SANITIZER WINTER SKY ETHYL ALCOHOL LIQUID TOPICAL 20140814 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-504_b2caf221-2b7b-4b05-bbc3-7372fcd0e565 41520-504 HUMAN OTC DRUG CAREONE ANTIBACTERIAL HAND SANITIZER SEASONS GREETINGS ETHYL ALCOHOL LIQUID TOPICAL 20140814 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 650 mg/mL N 20181231 41520-505_ca3e908a-df71-42cf-a4d1-65b9a6420a93 41520-505 HUMAN OTC DRUG CareOne Daily Facial Avobenzone, Octocrylene CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 American Sales Company AVOBENZONE; OCTOCRYLENE 3; 10 mL/100mL; mL/100mL N 20181231 41520-506_5eff6c82-3fea-3df6-e053-2991aa0a4e17 41520-506 HUMAN OTC DRUG CareOne Lubricant Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20170518 OTC MONOGRAPH FINAL part349 FOODHOLD U.S.A., LLC POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 41520-507_37c1d09a-d9ae-4c08-ab14-b1bcda9c2c17 41520-507 HUMAN OTC DRUG CareOne Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20160805 ANDA ANDA074661 American Sales Company NAPROXEN SODIUM 220 mg/1 N 20181231 41520-508_5eff6c82-3ff8-3df6-e053-2991aa0a4e17 41520-508 HUMAN OTC DRUG CareOne Lubricant Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20170518 OTC MONOGRAPH FINAL part349 FOODHOLD U.S.A., LLC CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 41520-511_df5ca1b3-061d-4480-bb56-3bebe4c7fb2a 41520-511 HUMAN OTC DRUG careone daytime severe cold flu relief acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20150831 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 41520-512_bc9d21da-4fbf-43a0-814a-77741189bf76 41520-512 HUMAN OTC DRUG careone childrens acetaminophen Acetaminophen SUSPENSION ORAL 20160408 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-513_b9692ba4-8ebc-40db-a9e0-87a4369f5fc1 41520-513 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 American Sales Company LORATADINE 10 mg/1 N 20181231 41520-514_10f95f4f-466e-4dba-b250-cbe12aaa5b2f 41520-514 HUMAN OTC DRUG CareOne Acetaminophen PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20160902 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41520-516_8593f7ef-399a-4bdc-bc73-4f5c77698f48 41520-516 HUMAN OTC DRUG CareOne Adult Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060620 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 41520-517_acd9cf65-36fc-4587-8a9e-d59597de0925 41520-517 HUMAN OTC DRUG care one ibuprofen ib Ibuprofen TABLET, FILM COATED ORAL 20060524 ANDA ANDA077349 American Sales Company IBUPROFEN 200 mg/1 N 20181231 41520-519_875330da-f823-4be5-9d23-ad1b2b1c842c 41520-519 HUMAN OTC DRUG Petrolatum White Petrolatum JELLY TOPICAL 19920715 OTC MONOGRAPH FINAL part347 Foodhold USA, LLC PETROLATUM 1 g/g N 20181231 41520-520_878f02c8-0781-450f-b321-76f840060dbf 41520-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100805 NDA NDA021855 Care One (American Sales Company) LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 41520-521_34c1079f-3550-4707-8e78-18c0b26b5078 41520-521 HUMAN OTC DRUG Care One Ibuprofen Junior Strength Ibuprofen TABLET, CHEWABLE ORAL 20100521 ANDA ANDA076359 American Sales Company IBUPROFEN 100 mg/1 N 20181231 41520-522_334efb13-38cc-4201-86dc-bb75ba5f45a0 41520-522 HUMAN OTC DRUG Baby Healing Petrolatum OINTMENT TOPICAL 20131113 OTC MONOGRAPH FINAL part347 American Sales Company PETROLATUM 41 g/100g N 20181231 41520-523_2cb8002b-40c8-4f85-8a93-e0a6c921c2f2 41520-523 HUMAN OTC DRUG CareOne Tussin DM Nighttime Cough dextromethorphan hbr, doxylamine succinate SOLUTION ORAL 20160831 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL N 20181231 41520-525_2362edeb-ac77-40c2-a066-757729e41e20 41520-525 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 American Sales Company LORATADINE 10 mg/1 N 20181231 41520-527_2362edeb-ac77-40c2-a066-757729e41e20 41520-527 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 American Sales Company LORATADINE 10 mg/1 N 20181231 41520-528_8b41c36f-d102-4f5e-9d6f-66eaf3780d13 41520-528 HUMAN OTC DRUG care one calcium antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 750 mg/1 N 20181231 41520-530_e2e1a239-ae03-4bf5-a17d-97075d91d3e1 41520-530 HUMAN OTC DRUG Acne Wash Oil-Free Salicylic Acid LIQUID TOPICAL 20131115 OTC MONOGRAPH FINAL part333D American Sales Company SALICYLIC ACID 2 g/100mL N 20181231 41520-531_2ccfe1d7-2250-4212-9345-44ceb105ca56 41520-531 HUMAN OTC DRUG Redness reliever tetrahydrozoline HCl LIQUID OPHTHALMIC 20110906 OTC MONOGRAPH FINAL part349 American Sales Company TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 41520-532_a8a645b6-c4f8-4c21-9bbf-661bd417e9de 41520-532 HUMAN OTC DRUG Advanced relief dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl LIQUID OPHTHALMIC 20110907 OTC MONOGRAPH FINAL part349 American Sales Company TETRAHYDROZOLINE HYDROCHLORIDE; DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE .5; 1; 10; 10 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41520-533_c80087c8-7936-48b4-98f9-2d17b96ebe7e 41520-533 HUMAN OTC DRUG Care One Naproxen Sodium Naproxen Sodium TABLET ORAL 20160708 ANDA ANDA074661 American Sales Company NAPROXEN SODIUM 220 mg/1 N 20181231 41520-534_2c04200d-a73f-4cca-91e4-90bb74bc37b6 41520-534 HUMAN OTC DRUG CareOne Tussin Mucus Plus Chest Congestion Guaifenesin SOLUTION ORAL 20160826 OTC MONOGRAPH FINAL part341 American Sales Company GUAIFENESIN 200 mg/10mL N 20181231 41520-535_5d978b52-4354-3d2e-e053-2991aa0ae0cb 41520-535 HUMAN OTC DRUG CareOne Ultra Lubricant Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20170518 OTC MONOGRAPH FINAL part349 FOODHOLD U.S.A., LLC POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 41520-538_4b954067-ba41-4889-acc6-b8e87c4aafef 41520-538 HUMAN OTC DRUG CareOne Cold Flu and sore throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20160803 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41520-540_33c05a6b-9577-4a1f-951f-d8097809ece1 41520-540 HUMAN OTC DRUG Baby Care Healing Petrolatum OINTMENT TOPICAL 20131113 OTC MONOGRAPH FINAL part347 American Sales Company PETROLATUM 41 g/100g N 20181231 41520-541_a4f8f2f1-8e6e-4d87-9827-6e3ba14febfb 41520-541 HUMAN OTC DRUG CareOne Healing Petrolatum OINTMENT TOPICAL 20131115 OTC MONOGRAPH FINAL part347 American Sales Company PETROLATUM 41 g/100g N 20181231 41520-544_f4804cea-2b42-4d4a-bd7f-5b40d70540a8 41520-544 HUMAN OTC DRUG Care One arthritis pain relief temporary minor Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051122 ANDA ANDA075077 American Sales Company ACETAMINOPHEN 650 mg/1 N 20181231 41520-546_3709b426-f32e-4f74-af1f-027830f6928b 41520-546 HUMAN OTC DRUG care one acid reducer and antacid dual action Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080801 ANDA ANDA077355 American Sales Company FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 41520-550_50f7fd7d-cdcd-4e5d-8cbd-8c307d74f40d 41520-550 HUMAN OTC DRUG Gas relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20101027 OTC MONOGRAPH FINAL part332 Care One (American Sales Company) DIMETHICONE 125 mg/1 E 20171231 41520-556_dea3b0bb-fddf-4c89-92ea-fbc22e2414c4 41520-556 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 20190826 OTC MONOGRAPH NOT FINAL part343 FOODHOLD U.S.A., LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41520-558_69ad993b-79b9-423e-86d6-ec14b3cbc7b9 41520-558 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20171127 OTC MONOGRAPH FINAL part358F Foodhold USA SALICYLIC ACID 40 mg/91 N 20181231 41520-561_109150e4-69f8-4961-9b01-782b5de6416e 41520-561 HUMAN OTC DRUG CareOne Nighttime Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20160411 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 41520-565_1f9360c9-927f-48b2-8bf9-c947ae5b5b41 41520-565 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Miconazole Athletes Foot Spray Talc Free AEROSOL, POWDER TOPICAL 20171020 OTC MONOGRAPH FINAL part333C Foodhold USA MICONAZOLE NITRATE 2.6 g/130g N 20181231 41520-566_acaacc3c-5e22-49d3-8267-0c6590250a60 41520-566 HUMAN OTC DRUG Miconazole Nitrate Jock Itch Spray Talc Free AEROSOL, SPRAY TOPICAL 20171020 OTC MONOGRAPH FINAL part333C American Sales Company MICONAZOLE NITRATE 1.3 g/130g N 20181231 41520-567_3811f4fe-12e7-4b37-a36c-04f924d88511 41520-567 HUMAN OTC DRUG Salicylic Acid Wart Remover Gel GEL TOPICAL 20171020 OTC MONOGRAPH FINAL part358B Foodhold USA SALICYLIC ACID .17 g/7g N 20181231 41520-568_a7c4686a-bda6-40bb-ad03-772d6f2b2908 41520-568 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20171020 OTC MONOGRAPH FINAL part358F Foodhold USA SALICYLIC ACID .17 g/9mL N 20181231 41520-569_1cfc7444-8799-42f9-a198-7b5c9fcd15e3 41520-569 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20171020 OTC MONOGRAPH FINAL part358B Foodhold USA SALICYLIC ACID .17 mg/9.8g N 20181231 41520-570_ba46089a-3ac3-45f4-b5dc-372281b112dc 41520-570 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20171020 OTC MONOGRAPH FINAL part358F Foodhold USA SALICYLIC ACID 40 mg/41 N 20181231 41520-571_44a0799b-2615-427e-8cd5-84ccc17d9b0c 41520-571 HUMAN OTC DRUG care one aller ease fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110415 ANDA ANDA076447 American Sales Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 41520-578_050bda92-6efd-46c1-a412-77e46223557e 41520-578 HUMAN OTC DRUG CareOne Adult Tussin DM sugar free Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20040504 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 41520-580_45d1a1bc-b547-437a-82dc-13361b8171a8 41520-580 HUMAN OTC DRUG careone cold max acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20160330 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 41520-582_25d531a1-fda9-4c3c-9db2-b4740675536e 41520-582 HUMAN OTC DRUG Care One Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20130120 OTC MONOGRAPH NOT FINAL part356 American Sales SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 41520-584_85af4eb2-7f97-4d88-ba4f-20ecf457e398 41520-584 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20161130 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 41520-588_0be322b8-6ee7-4844-8ce8-f899c3dbd43a 41520-588 HUMAN OTC DRUG CareOne Antacid Aluminum Hydroxide, Magnesium Hydroxide, Simethicone SUSPENSION ORAL 20130910 OTC MONOGRAPH FINAL part332 American Sales Company ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 41520-590_b45ec372-e615-4df9-b8e9-8772b700c3e4 41520-590 HUMAN OTC DRUG careone pain relief acetaminophen SUSPENSION ORAL 20111208 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-592_3fb2a85b-8dbd-4033-afb9-ca68ee1054ca 41520-592 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130906 OTC MONOGRAPH NOT FINAL part356 Foodhold U.S.A. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 41520-593_8dd0e27d-0790-40c4-9217-3f428cfac410 41520-593 HUMAN OTC DRUG CareOne Tussin DM cough plus chest congestion Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20160805 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 41520-595_bbe913b7-4912-4943-bd11-ce7ac407e823 41520-595 HUMAN OTC DRUG care one calcium antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 1000 mg/1 N 20181231 41520-598_13f1779c-0184-1d96-e054-00144ff8d46c 41520-598 HUMAN OTC DRUG Cold Head Congestion Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110601 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41520-599_13f19fdb-1843-29ee-e054-00144ff88e88 41520-599 HUMAN OTC DRUG Cold Multi-Symptom Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110601 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41520-600_bc157eb0-7720-4cda-b239-2866b84baa52 41520-600 HUMAN OTC DRUG Careone ibuprofen junior strength Ibuprofen TABLET, CHEWABLE ORAL 20100521 ANDA ANDA076359 American Sales Company IBUPROFEN 100 mg/1 N 20181231 41520-601_13f13381-7ae0-260f-e054-00144ff8d46c 41520-601 HUMAN OTC DRUG Allergy Multi-Symptom ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110801 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 41520-602_13f13381-7af4-260f-e054-00144ff8d46c 41520-602 HUMAN OTC DRUG Sinus and Allergy PE Maximum Strength CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110701 OTC MONOGRAPH FINAL part341 American Sales Company CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 41520-603_13f1779c-016f-1d96-e054-00144ff8d46c 41520-603 HUMAN OTC DRUG Cold Head Congestion Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110901 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 41520-604_05f3f6e2-bf37-41b5-a389-8f35a75d88cf 41520-604 HUMAN OTC DRUG care one ibuprofen Ibuprofen TABLET ORAL 20040413 ANDA ANDA072096 American Sales Company IBUPROFEN 200 mg/1 N 20181231 41520-606_13f13381-7acd-260f-e054-00144ff8d46c 41520-606 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen TABLET ORAL 20100801 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 325 mg/1 N 20181231 41520-609_06356fd0-67e1-4f04-8b27-329ac2f3247e 41520-609 HUMAN OTC DRUG CareOne Acid Relief Ranitidine TABLET, FILM COATED ORAL 20160720 ANDA ANDA091429 American Sales Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 41520-611_9cf5a337-e1cc-4db7-b8bf-974eb5dad658 41520-611 HUMAN OTC DRUG Careone Moisturizing Dandruff Selenium Sulfide SHAMPOO TOPICAL 20110819 OTC MONOGRAPH FINAL part358H American Sales Company SELENIUM SULFIDE 1 mL/100mL N 20181231 41520-612_72698d8e-bc0c-4d3d-a82c-bf217bf18ab9 41520-612 HUMAN OTC DRUG CareOne Allergy Relief 24 Hour Loratadine TABLET ORAL 20060602 ANDA ANDA076301 American Sales Company LORATADINE 10 mg/1 N 20181231 41520-613_6735afe8-97aa-4baa-82e5-1b88f787c0cd 41520-613 HUMAN OTC DRUG Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20151210 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 41520-614_5e3e215b-f997-4366-9bba-42a47bd5e723 41520-614 HUMAN OTC DRUG MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20110819 OTC MONOGRAPH FINAL part358H AMERICAN SALES COMPANY SELENIUM SULFIDE 1 mL/100mL N 20181231 41520-615_be11135d-8068-49a0-9882-049a9a090f0a 41520-615 HUMAN OTC DRUG CareOne Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20160411 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-617_19045840-2d25-43af-8c92-f36c8b903b28 41520-617 HUMAN OTC DRUG CareOne Acid Reducer Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20161004 ANDA ANDA077355 American Sales Company FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 41520-619_b3600254-6acf-4c02-a333-50d6401f4419 41520-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20120915 OTC MONOGRAPH FINAL part347 American Sales Co DIMETHICONE 1.3 kg/100mL N 20181231 41520-620_60ebdc33-d41d-40d5-a5ba-3cb824115c8d 41520-620 HUMAN OTC DRUG CARE ONE MEDICATED SELENIUM SULFIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH FINAL part358H AMERICAN SALES COMPANY SELENIUM SULFIDE 10 mg/mL N 20181231 41520-621_2ac8a2a1-3a9b-4e8d-8124-5f8dd7cfb96c 41520-621 HUMAN OTC DRUG CARE ONE MOISTURIZING SELENIUM SULFIDE LIQUID TOPICAL 20130715 OTC MONOGRAPH FINAL part358H AMERICAN SALES COMPANY SELENIUM SULFIDE 10 mg/mL N 20181231 41520-622_fa64738e-65a2-4267-b5bf-51c783b28c80 41520-622 HUMAN OTC DRUG CAREONE MOISTURIZING DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20150113 OTC MONOGRAPH FINAL part358H AMERICAN SALES COMPANY SELENIUM SULFIDE 10 mg/mL N 20181231 41520-626_17d07bd2-664f-4c67-8c00-0596a2d57ffa 41520-626 HUMAN OTC DRUG CareOne Daily Moisturizer Broad Spectrum SPF15 Sunscreen Avobenzone, Homosalate, Octinoxate, Octocrylene LOTION TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 American Sales Company AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 3; 5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 41520-630_6642f605-701c-4943-894e-304888cff191 41520-630 HUMAN OTC DRUG Motion Sickness Relief Original Formula Dimenhydrinate TABLET ORAL 20100715 OTC MONOGRAPH FINAL part336 Care One (American Sales Company) DIMENHYDRINATE 50 mg/1 N 20181231 41520-632_fdbc59cc-7454-486c-9412-96cb37f7a2aa 41520-632 HUMAN OTC DRUG CareOne Childrens Allergy Relief Diphenhydramine HCl SOLUTION ORAL 20160412 OTC MONOGRAPH FINAL part341 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 41520-634_1a76d344-5328-4f18-afbd-6f1410f520fa 41520-634 HUMAN OTC DRUG CareOne Nighttime Sleep Aid Doxylamine succinate TABLET ORAL 20160506 ANDA ANDA040167 American Sales Company DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 41520-636_05bd87e9-0e7a-4340-b518-3e495ba8d3d0 41520-636 HUMAN OTC DRUG CareOne Tussin DM cough plus chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20160805 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 41520-639_046c765c-1db2-43e1-98c1-e7f31ff5e45d 41520-639 HUMAN OTC DRUG CareOne Cold plus Flu Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20160914 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41520-645_20a962f9-f6a2-4d9a-ad65-d0eeba10bce6 41520-645 HUMAN OTC DRUG CareOne loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120521 ANDA ANDA091292 American Sales Company LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 41520-647_1d0ec628-6385-4465-a8d4-4ee560b92b05 41520-647 HUMAN OTC DRUG care one ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20040413 ANDA ANDA072096 American Sales Company IBUPROFEN 200 mg/1 N 20191231 41520-648_d70dc899-ee4f-4322-aa77-c2861639436f 41520-648 HUMAN OTC DRUG Care One Nasal Four Phenylephrine hydrochloride SPRAY NASAL 20040524 OTC MONOGRAPH FINAL part341 American Sales Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 41520-652_9c2cb113-af89-4bd5-90a8-89e3a22307a5 41520-652 HUMAN OTC DRUG CareOne Mucus Relief ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160720 ANDA ANDA078912 American Sales Company GUAIFENESIN 600 mg/1 N 20181231 41520-656_410fb2f2-3d95-4617-a61e-bcb930485389 41520-656 HUMAN OTC DRUG CareOne Daytime Cold Flu Relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20130813 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 41520-657_5b7f2c0d-9b3a-46d6-a18b-dc3545a22590 41520-657 HUMAN OTC DRUG Care One Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20040301 OTC MONOGRAPH FINAL part332 American Sales Company DIMETHICONE 180 mg/1 N 20181231 41520-660_ac9aa609-ac3b-40fe-9156-34c54901fc12 41520-660 HUMAN OTC DRUG care one ibuprofen childrens Ibuprofen SUSPENSION ORAL 20040504 ANDA ANDA074937 American Sales Company IBUPROFEN 100 mg/5mL N 20181231 41520-666_4f622c86-d8af-4c26-948e-a1cbdb592769 41520-666 HUMAN OTC DRUG CareOne Cold and Cough Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20051028 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 41520-684_e08cd96e-0788-4154-a174-a621b2abe730 41520-684 HUMAN OTC DRUG Stool Softener Laxative Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20171231 OTC MONOGRAPH NOT FINAL part334 Care One (American Sales Company) DOCUSATE SODIUM 100 mg/1 N 20191231 41520-685_2b894bb8-c401-43f6-a775-06b08ea83ef7 41520-685 HUMAN OTC DRUG Care One ibuprofen childrens Ibuprofen SUSPENSION ORAL 20080801 ANDA ANDA074937 American Sales Company IBUPROFEN 100 mg/5mL N 20181231 41520-693_489e98bb-ef9e-4da9-a9d6-d6ef78f11b3f 41520-693 HUMAN OTC DRUG Anti-Aging Vitamin Complex 7-in-1 Broad Spectrum SPF15 Sunscreen Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 American Sales Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 g/100mL; g/100mL; g/100mL N 20181231 41520-695_2e59a3ee-949f-49e2-8e43-75471bd7c522 41520-695 HUMAN OTC DRUG CareOne Ibuprofen Ibuprofen TABLET, COATED ORAL 20160720 ANDA ANDA077349 American Sales Company IBUPROFEN 200 mg/1 N 20181231 41520-701_542d77e8-e3e2-4f5e-af3a-da94e2f17124 41520-701 HUMAN OTC DRUG careone nicotine Nicotine Polacrilex LOZENGE ORAL 20060307 ANDA ANDA077007 American Sales Company NICOTINE 2 mg/1 N 20181231 41520-703_afb1ffda-164a-414b-99c7-e07f4b164410 41520-703 HUMAN OTC DRUG CareOne Allergy Relief Fluticasone propionate SPRAY, METERED NASAL 20160823 ANDA ANDA207957 American Sales Company FLUTICASONE PROPIONATE 50 ug/1 N 20181231 41520-704_33219c95-eaa6-47c0-899a-bdebaecb74bb 41520-704 HUMAN OTC DRUG Childrens Plus Multi Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride SUSPENSION ORAL 20151031 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 41520-706_50e9d472-7330-469f-ab20-8b52cc4fd8aa 41520-706 HUMAN OTC DRUG CareOne Calcium Antacid calcium carbonate TABLET, CHEWABLE ORAL 20170727 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 750 mg/1 N 20181231 41520-707_e99d3d4c-04df-4de9-96d7-09428badc4b5 41520-707 HUMAN OTC DRUG CareOne Acid Relief Famotidine TABLET ORAL 20160922 ANDA ANDA077351 American Sales Company FAMOTIDINE 20 mg/1 N 20181231 41520-709_fce9fe18-eb0d-42c9-b7c2-0142d0e12a2e 41520-709 HUMAN OTC DRUG CareOne Infants Acetaminophen Acetaminophen SUSPENSION ORAL 20161214 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-711_21ae0d43-b78d-4f7e-90f1-01479454fc6b 41520-711 HUMAN OTC DRUG careone nicotine Nicotine polacrilex GUM, CHEWING ORAL 20171113 ANDA ANDA206394 American Sales Company NICOTINE 2 mg/1 N 20181231 41520-712_4210283c-c1a7-48a1-a701-66f96ead270d 41520-712 HUMAN OTC DRUG CareOne Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20160415 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 41520-713_31187c98-6706-4962-91f6-022a390cda39 41520-713 HUMAN OTC DRUG Careone daytime severe cold and flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20160524 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 41520-717_21a3302d-d141-4669-85a2-365027c7cae6 41520-717 HUMAN OTC DRUG CareOne Allergy Relief diphenhydramine HCl CAPSULE ORAL 20161028 OTC MONOGRAPH FINAL part341 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41520-719_8046242f-b9de-461c-a8b1-04a1b75443ff 41520-719 HUMAN OTC DRUG CAREONE MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20141117 OTC MONOGRAPH FINAL part358H AMERICAN SALES COMPANY SELENIUM SULFIDE 10 mg/mL N 20181231 41520-721_abf6717d-19f3-41cc-8ebe-f6109b4ba59f 41520-721 HUMAN OTC DRUG American Sales Company CareOne Fluoride PASTE, DENTIFRICE DENTAL 20140601 OTC MONOGRAPH FINAL part355 American Sales Company SODIUM FLUORIDE .243 g/100g N 20181231 41520-723_66b3ddb4-6dc9-4161-a0db-52c026560b85 41520-723 HUMAN OTC DRUG CareOne Infants Acetaminophen acetaminophen suspension SUSPENSION ORAL 20161216 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-727_27a0ad58-8aad-4b18-b5b6-c47252a59f38 41520-727 HUMAN OTC DRUG careone esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170926 ANDA ANDA207193 American Sales Company ESOMEPRAZOLE 20 mg/1 N 20181231 41520-729_1d94f8cc-3e57-4f8b-a934-9a4058d75013 41520-729 HUMAN OTC DRUG CareOne Fast Acting Nasal Phenylephrine hydrochloride SPRAY NASAL 20161130 OTC MONOGRAPH FINAL part341 American Sales Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 41520-733_55da6ed3-9c46-48bd-983d-982d3b611dd2 41520-733 HUMAN OTC DRUG CareOne Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140908 OTC MONOGRAPH FINAL part341 American Sales Company N 20181231 41520-734_4f75974e-7a47-4e1f-996d-c76ea54e0127 41520-734 HUMAN OTC DRUG CareOne Nicotine Nicotine Polacrilex LOZENGE ORAL 20130628 ANDA ANDA203690 American Sales Company NICOTINE 2 mg/1 N 20181231 41520-735_46fba7be-c05c-43c2-b932-4f1e9bdf9f12 41520-735 HUMAN OTC DRUG CareOne Mucus Relief DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160819 ANDA ANDA091070 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 41520-751_55e11057-8550-49b0-a021-953d595dfd37 41520-751 HUMAN OTC DRUG careone pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120203 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 41520-758_8471db91-e87a-4399-a250-276a9f174fbd 41520-758 HUMAN OTC DRUG CareOne Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140510 ANDA ANDA091292 American Sales Company LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 41520-759_98953bb2-75c6-4bd1-a08c-5ea35e592eac 41520-759 HUMAN OTC DRUG care one pain relief Acetaminophen SUSPENSION ORAL 20110211 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-763_27dd9aa3-c24d-479a-bf1e-87a4a74111fc 41520-763 HUMAN OTC DRUG CareOne Nitetime Severe Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20151012 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 41520-766_1daad7ea-bffa-497e-87c8-4edd682299c0 41520-766 HUMAN OTC DRUG CareOne Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140730 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41520-767_2613d6ab-6e0c-43c3-b3b7-0e72b2d74663 41520-767 HUMAN OTC DRUG CareOne Diarrhea Control loperamide HCl SUSPENSION ORAL 20160920 ANDA ANDA091292 American Sales Company LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 41520-770_0fcdbf0e-7e51-4159-a5dc-7421b5521b63 41520-770 HUMAN OTC DRUG careone allergy and cough severe sinus congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160706 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41520-773_13b48613-bd2e-44da-901c-b6094aed7c74 41520-773 HUMAN OTC DRUG CareOne Severe Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20160407 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41520-774_35f841ad-5783-4887-e054-00144ff88e88 41520-774 HUMAN OTC DRUG Pressure and Pain and Cold ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20160801 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 41520-777_b186f2f0-a184-4e74-8b4f-917292ad055f 41520-777 HUMAN OTC DRUG Cold and Hot paim relieving CareOne Menthol 16.00% LIQUID TOPICAL 20150714 OTC MONOGRAPH NOT FINAL part348 CareOne MENTHOL 16 g/100mL N 20191231 41520-778_d24e2236-80cb-4ffc-ad5d-7ec5a7fa4086 41520-778 HUMAN OTC DRUG careone allergy relief Diphenhydramine Hydrochloride TABLET ORAL 20170921 OTC MONOGRAPH FINAL part341 American Sales Company DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 41520-781_3a8be76f-4b3d-4d44-a312-c2636f19d834 41520-781 HUMAN OTC DRUG CareOne Allergy Relief Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20160929 ANDA ANDA078336 American Sales Company CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 41520-783_d1c91603-f357-47d9-809c-7835d5fac320 41520-783 HUMAN OTC DRUG CareOne Cold and Sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20160805 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; 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ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 41520-810_5c73e06f-7a8b-4367-a3be-0d9ad395f8a3 41520-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part333A Foodhold U.S.A. LLC ISOPROPYL ALCOHOL 500 mg/mL N 20181231 41520-813_7487795e-c61b-4a47-9b44-e6b362658e1f 41520-813 HUMAN OTC DRUG CareOne Diarrhea Control Loperamide HCl TABLET, FILM COATED ORAL 20160914 ANDA ANDA075232 American Sales Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20191231 41520-816_41e92960-195a-49bc-9e48-5d7d11ed9622 41520-816 HUMAN OTC DRUG CareOne Acid Reducer Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20161014 ANDA ANDA202319 American Sales Company LANSOPRAZOLE 15 mg/1 N 20181231 41520-817_eda8ca7f-49b0-4953-bd5b-469338260312 41520-817 HUMAN OTC DRUG care one nasal sinus oxymetazoline hydrochloride SPRAY NASAL 20040524 OTC MONOGRAPH FINAL part341 American Sales Company OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 41520-818_1c0b9232-919e-4935-a6b1-cc1f756f6c22 41520-818 HUMAN OTC DRUG CareOne Infants Acetaminophen Acetaminophen SUSPENSION ORAL 20161214 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-822_75f4aca4-d8c8-4042-991f-142b3f17caf8 41520-822 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20150324 OTC MONOGRAPH FINAL part346 FOODHOLD U.S.A., LLC WITCH HAZEL 979 mg/mL N 20181231 41520-827_7ae805e1-e41e-4414-9a1c-1d55298fca5b 41520-827 HUMAN OTC DRUG Quick Relief Creamy Diaper Rash Zinc Oxide CREAM TOPICAL 20131115 OTC MONOGRAPH FINAL part347 American Sales Company ZINC OXIDE 130 mg/g N 20181231 41520-831_9edb1c10-c02d-4850-9253-4373efb97035 41520-831 HUMAN OTC DRUG CareOne Cold and Sinus Phenylephrine hydrochloride SOLUTION/ DROPS NASAL 20161020 OTC MONOGRAPH FINAL part341 American Sales Company PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 41520-837_9d485e64-a618-4dcf-9d22-07e0b8c9e4b6 41520-837 HUMAN OTC DRUG care one pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20040413 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN; 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POLYETHYLENE GLYCOL 400; HYPROMELLOSES 2; 10; 2 mg/mL; mg/mL; mg/mL N 20181231 41520-866_b794ca4e-ab71-4da0-a973-7c0a699476ee 41520-866 HUMAN OTC DRUG care one lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070829 OTC MONOGRAPH FINAL part358G American Sales Company PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 41520-869_61a4691e-e9ae-4d8b-91c2-f6cebef0f30a 41520-869 HUMAN OTC DRUG CareOne 7-in-1 Anti-Aging Vitamin Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 American Sales Company AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 mL/100mL; mL/100mL; mL/100mL N 20181231 41520-871_87ea9f20-07a3-49b6-a1f8-b3d4da0711b1 41520-871 HUMAN OTC DRUG Careone Extra Strength Cold and Hot Menthol PATCH TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part348 American Sales Company MENTHOL .05 mg/1 N 20181231 41520-872_d12b52da-01c9-4b80-8bc2-8da13f7d6c9f 41520-872 HUMAN OTC DRUG Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20161130 OTC MONOGRAPH FINAL part341 Care One (American Sales Company) N 20181231 41520-873_cb9ea8a3-f475-4c5e-a328-faf0bcb209ab 41520-873 HUMAN OTC DRUG care one nicotine Nicotine Polacrilex LOZENGE ORAL 20060307 ANDA ANDA077007 American Sales Company NICOTINE 4 mg/1 N 20181231 41520-878_51970119-d31b-482c-98cc-d651f003f3f1 41520-878 HUMAN OTC DRUG PEANUTS ANTI-CAVITY FLUORIDE TOOTHPASTE SODIUM FLUORIDE PASTE DENTAL 20100913 OTC MONOGRAPH FINAL part355 American Sales Company SODIUM FLUORIDE .24 g/100g E 20171231 41520-881_81b31070-9b03-4ce4-8aac-a334544842ae 41520-881 HUMAN OTC DRUG CareOne Nasal and Sinus Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20170925 OTC MONOGRAPH FINAL part341 American Sales Company PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 41520-883_35f843ff-e97d-51e4-e054-00144ff88e88 41520-883 HUMAN OTC DRUG Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN and CAFFEINE TABLET ORAL 20160101 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN; 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TOPICAL 20150506 OTC MONOGRAPH NOT FINAL part334 FOODHOLD U.S.A., LLC MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 41520-900_c1879e86-94ac-45c6-8b58-8561692d8b12 41520-900 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20040510 20191018 OTC MONOGRAPH NOT FINAL part343 FOODHOLD U.S.A., LLC ACETAMINOPHEN 500 mg/1 N 20181231 41520-901_cf466cf3-f45d-49a6-abdf-2563c70d6da9 41520-901 HUMAN OTC DRUG CareOne Acid Reducer Famotidine TABLET ORAL 20161004 ANDA ANDA075400 American Sales Company FAMOTIDINE 10 mg/1 N 20181231 41520-902_dc058274-7a91-4970-a502-3d399279635f 41520-902 HUMAN OTC DRUG careone childrens allergy relief Cetirizine HCl SOLUTION ORAL 20160623 ANDA ANDA204226 American Sales Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 41520-904_3ea0e34a-9f3a-4a11-bd8a-9772e95aecf1 41520-904 HUMAN OTC DRUG CareOne Calcium Antacid calcium carbonate TABLET, CHEWABLE ORAL 20170727 OTC MONOGRAPH FINAL part331 American Sales Company CALCIUM CARBONATE 1000 mg/1 N 20181231 41520-906_7ca1f4ef-9ad0-4478-bc5b-f06aabb12da7 41520-906 HUMAN OTC DRUG CareOne Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate SOLUTION ORAL 20060907 OTC MONOGRAPH FINAL part341 American Sales Company PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 41520-909_a9b245d4-8bfb-4dbc-a058-f7b40a2dd4d7 41520-909 HUMAN OTC DRUG Complete Beauty Octinoxate, Zinc Oxide LOTION TOPICAL 20100113 OTC MONOGRAPH NOT FINAL part352 American Sales Co OCTINOXATE; ZINC OXIDE 61.2; 30.6 mg/mL; mg/mL N 20181231 41520-911_d3d1ae52-fd05-4ab9-8aab-db6d86eab410 41520-911 HUMAN OTC DRUG Medicated Pain Relief Menthol PATCH TOPICAL 20110916 OTC MONOGRAPH NOT FINAL part348 American Sales Company MENTHOL 428.5 mg/1 E 20171231 41520-913_9b827ae5-8c6c-46ea-89ab-d76dda3f0ed7 41520-913 HUMAN OTC DRUG CareOne Triacting Night Time Cold and Cough Childrens Diphenhydramine HCl, Phenylephrine HCl SOLUTION ORAL 20090605 OTC MONOGRAPH FINAL part341 American Sales Company PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE 2.5; 6.25 mg/5mL; mg/5mL N 20181231 41520-915_39c750fa-5a87-4197-93da-d09984fbe8ce 41520-915 HUMAN OTC DRUG care one omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080229 NDA NDA022032 American Sales Company OMEPRAZOLE 20 mg/1 N 20181231 41520-916_89897a3e-428d-4d82-9cc6-258db64e068b 41520-916 HUMAN OTC DRUG care one miconazole 1 Miconazole nitrate KIT 20101119 ANDA ANDA079114 American Sales Company N 20181231 41520-919_7b18bf87-70ee-4e35-acf6-ba61173d5aa7 41520-919 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 FOODHOLD U.S.A., LLC ACETAMINOPHEN 500 mg/1 N 20181231 41520-920_ffb5218e-94c2-41b8-a950-dc85b3e9d4f3 41520-920 HUMAN OTC DRUG Care One Cold Mutli Symptom acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20151019 OTC MONOGRAPH FINAL part341 American Sales Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 41520-927_cd539300-2278-45c6-bcd3-8282cd850ca7 41520-927 HUMAN OTC DRUG Maximum Strength Original Diaper Rash Zinc Oxide CREAM TOPICAL 20131115 OTC MONOGRAPH FINAL part347 American Sales Company ZINC OXIDE 400 mg/g N 20181231 41520-933_bcefb803-a317-4139-9fff-3501e717d57a 41520-933 HUMAN OTC DRUG careone ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20171221 ANDA ANDA076359 American Sales Company IBUPROFEN 100 mg/1 N 20191231 41520-937_76c9e270-34e9-4790-aea6-3730f3e98560 41520-937 HUMAN OTC DRUG CareOne Tussin CF Multi Symptom Cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20160805 OTC MONOGRAPH FINAL part341 American Sales Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 41520-941_454662f8-b269-4d9d-810c-160c4a8d2486 41520-941 HUMAN OTC DRUG CAREONE LEMON ETHYL ALCOHOL LIQUID TOPICAL 20140126 OTC MONOGRAPH NOT FINAL part333E AMERICAN SALES COMPANY ALCOHOL 700 mg/mL N 20181231 41520-941_affcb075-929c-40a3-997f-b82520e5ccc2 41520-941 HUMAN OTC DRUG CAREONE Lemon Ethyl Alcohol LIQUID TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333E American Sales Company ALCOHOL 700 mg/mL N 20181231 41520-942_ddfffd2d-cc2d-4538-b3c7-734995e6f0ec 41520-942 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20111210 OTC MONOGRAPH NOT FINAL part333A FOODHOLD U.S.A., LLC HYDROGEN PEROXIDE 30 mg/mL N 20181231 41520-946_35882ee4-4394-4487-9d22-7906469a5695 41520-946 HUMAN OTC DRUG careone pain relief infants Acetaminophen SUSPENSION ORAL 20110902 OTC MONOGRAPH NOT FINAL part343 American Sales Company ACETAMINOPHEN 160 mg/5mL N 20181231 41520-949_81024d70-dda9-4aed-af97-de991e37b527 41520-949 HUMAN OTC DRUG careone milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20120826 OTC MONOGRAPH NOT FINAL part334 American Sales Company MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 41520-950_921710e8-7761-4c68-bbe2-d547c898f714 41520-950 HUMAN OTC DRUG CareOne Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130922 ANDA ANDA091429 American Sales Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 41520-951_d6cc29b1-6c6c-46b7-8dc3-1fe849533b4f 41520-951 HUMAN OTC DRUG CareOne Day Time Severe Cold Night Time Cold and Flu Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, diphenhydramine HCl KIT 20140826 OTC MONOGRAPH FINAL part341 American Sales Company N 20181231 41520-952_692e0fa0-ae01-4b68-95ec-5121e7dbfbb8 41520-952 HUMAN OTC DRUG Hand wash Benzalkonium chloride SOAP TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333A FOODHOLD U.S.A., LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 41520-956_ce4ef261-c742-4df9-afa4-0cee21145a99 41520-956 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 FOODHOLD U.S.A., LLC ACETAMINOPHEN; 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SODIUM FLUORIDE .02 mg/100mL E 20171231 41595-1058_6ec59bf1-1ccd-4428-a013-f42954521a9e 41595-1058 HUMAN OTC DRUG Ammens Medicated Powder Original Zinc Oxide POWDER TOPICAL 20030201 OTC MONOGRAPH FINAL part347 Idelle Labs, Ltd ZINC OXIDE 9.1 g/100g N 20181231 41595-1059_04eebc94-3032-4757-be4d-875353c1d10a 41595-1059 HUMAN OTC DRUG Ammens Medicated Powder Shower Fresh Formula Zinc Oxide POWDER TOPICAL 20030201 OTC MONOGRAPH FINAL part347 Idelle Labs, Ltd ZINC OXIDE 9.1 g/100g N 20181231 41595-1060_f3d37460-d4cb-4bc2-a3b2-18ed3091a3d0 41595-1060 HUMAN OTC DRUG Ammens Medicated Powder Original Zinc Oxide POWDER TOPICAL 20171231 OTC MONOGRAPH FINAL part347 Idelle Labs, Ltd ZINC OXIDE 5 g/100g N 20181231 41595-1061_213a3fb4-d15a-4a72-aa92-dee7fa228356 41595-1061 HUMAN OTC DRUG Ammens Medicated Powder Shower Fresh Zinc Oxide POWDER TOPICAL 20171231 OTC MONOGRAPH FINAL part347 Idelle Labs, Ltd ZINC OXIDE 5 g/100g N 20181231 41595-3020_af88c848-2eb4-48f0-8bac-b13b2c5b5bd4 41595-3020 HUMAN OTC 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41595-5522 HUMAN OTC DRUG Sure for Men Invisible Solid Antiperspirant Outdoor Sport Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20111015 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g E 20171231 41595-5523_c50f9911-25be-4247-ba7c-9e85912fa3b4 41595-5523 HUMAN OTC DRUG Pert Plus for Men Daily Dandruff Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 20100401 OTC MONOGRAPH FINAL part358H Idelle Labs, Ltd PYRITHIONE ZINC 1 mL/100mL E 20171231 41595-5526_b6bf7b2b-aa1b-4a34-8dcb-a28bcefd7311 41595-5526 HUMAN OTC DRUG Pert Plus Dandruff Plus Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 20091201 OTC MONOGRAPH FINAL part358H Idelle Labs, Ltd PYRITHIONE ZINC .45 mL/100mL E 20171231 41595-5527_b860c8fd-50ab-478a-9820-523f1b288c3b 41595-5527 HUMAN OTC DRUG Sure for Women Invisible Solid Citrus Escape STICK TOPICAL 20091210 OTC MONOGRAPH FINAL part350 Innovative Brands, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g E 20171231 41595-5528_62807030-e650-4c47-ae77-95a6c4b0b54b 41595-5528 HUMAN OTC DRUG Sure for Women Invisible Solid Sparkling Bloom STICK TOPICAL 20091210 OTC MONOGRAPH FINAL part350 Innovative Brands, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g E 20171231 41595-5529_2fc22278-4e90-445e-a5d2-a5a45b6f1610 41595-5529 HUMAN OTC DRUG Sure for Women Invisible Solid Fresh Essence STICK TOPICAL 20091210 OTC MONOGRAPH FINAL part350 Innovative Brands, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g E 20171231 41595-5537_4ebeeeeb-1a70-46b2-8d03-df04b13a9be2 41595-5537 HUMAN OTC DRUG Sure for Women Invisible Solid Unscented STICK TOPICAL 20091210 OTC MONOGRAPH FINAL part350 Innovative Brands, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g E 20171231 41595-5545_59cd4961-22ee-4b45-85f1-91d34892f64f 41595-5545 HUMAN OTC DRUG Sure Invisible Solid Fresh and Cool Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20150101 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g E 20171231 41595-5546_8e9b2a3d-6079-42fa-8b72-8ac722663d4b 41595-5546 HUMAN OTC DRUG Sure Original Solid Fresh and Cool Aluminum Zirconium Tricholorohydrex GLY STICK TOPICAL 20150101 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 16 g/100g E 20171231 41595-6502_02b5ae60-97b4-4c00-8fc9-ea5181a6f15d 41595-6502 HUMAN OTC DRUG Pert Plus 2 in 1 Shampoo and Conditioner Anti-Dandruff Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 20120601 OTC MONOGRAPH FINAL part358H Idelle Labs, Ltd PYRITHIONE ZINC 1 mL/100mL E 20171231 41595-6503_d5990c17-51b6-4490-835c-cde48e32ebdb 41595-6503 HUMAN OTC DRUG Pert Plus 2 in 1 Shampoo and Conditioner Dry Scalp Care Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 20120601 OTC MONOGRAPH FINAL part358H Idelle Labs, Ltd PYRITHIONE ZINC 1 mL/100mL E 20171231 41595-7005_0c08ec62-0334-4c16-91a3-2b3f49fc9a14 41595-7005 HUMAN OTC DRUG Brut Anti-perspirant and Deodorant Original Fragrance Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20101204 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g E 20171231 41595-7007_5ce1ed8c-d828-4917-9c0d-49aeb930d6f4 41595-7007 HUMAN OTC DRUG BRUT Active Sport Aluminum Zirconium Tetrachlorohydrex Gly GEL TOPICAL 20130101 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 16.15 g/85g E 20171231 41595-7008_589b125a-6546-410a-ad84-698ced187ee6 41595-7008 HUMAN OTC DRUG Brut Black Ice Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20131126 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g E 20171231 41595-7009_8a2e5270-6eb9-48c3-9ebf-843ff7f33f9c 41595-7009 HUMAN OTC DRUG Brut Blue Wave Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20131126 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g E 20171231 41595-7010_67701fb0-90e3-496d-b9e0-ccf43e3b0a86 41595-7010 HUMAN OTC DRUG Brut Overdrive Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20141028 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g E 20171231 41595-7011_7d2f1499-6037-4498-95c8-565a56e6fd70 41595-7011 HUMAN OTC DRUG Brut Stamina Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20141028 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g E 20171231 41595-7012_60dac9de-495f-40c0-8b80-80e6fca7eb78 41595-7012 HUMAN OTC DRUG Brut Arctic Force Aluminum Zirconium Tetrachlorohydrex Gly AEROSOL TOPICAL 20161116 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g E 20171231 41595-7013_4f3a50f2-3784-4069-99b2-9f7a6589a197 41595-7013 HUMAN OTC DRUG Brut ACTIVE SPORT Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20171231 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 41595-7101_fded4583-1798-4ffd-a892-685b6be90eee 41595-7101 HUMAN OTC DRUG Brut Anti-perspirant and Deodorant Original Fragrance Aluminum Chlorohydrate AEROSOL TOPICAL 20030401 OTC MONOGRAPH FINAL part350 Idelle Labs, Ltd ALUMINUM CHLOROHYDRATE 8.8 g/100g N 20181231 41900-100_69db7bce-3f58-441b-8eb2-141cac252fa2 41900-100 HUMAN OTC DRUG Quik Gel Advanced Hand Sanitizing Gel GEL TOPICAL 20090905 OTC MONOGRAPH NOT FINAL part333 Cinogen Cosmetics Zhaoqing, LTD. ALCOHOL; TRICLOSAN .62; .03 mL/mL; mL/mL E 20171231 41900-110_d63a1401-f218-45bc-9b8f-9343ac2d2ffe 41900-110 HUMAN OTC DRUG Take Care Clinic Instant Hand Sanitizer Spray ALCOHOL SPRAY TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Cinogen Cosmetics Zhaoqing, Ltd. ALCOHOL 62 mL/100mL E 20171231 41900-200_c1f1baa9-f90b-4b8c-bea6-ebe8707dbcce 41900-200 HUMAN OTC DRUG Quik Gel Advanced Hand Sanitizing Gel GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Cinogen Cosmetics Zhaoqing, LTD. ALCOHOL; TRICLOSAN .62; .03 g/g; g/g E 20171231 41900-300_62ecf9eb-1786-4dc9-9f58-2ec677f5aa6b 41900-300 HUMAN OTC DRUG Quik Spray Advanced Hand Sanitizing Spray SPRAY TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Cinogen Cosmetics Zhaoqing, LTD. ALCOHOL .62 mL/mL E 20171231 41900-400_c558964f-0a02-4190-903b-836f54cc89e1 41900-400 HUMAN OTC DRUG Quik Wipes Advanced Hand Sanitizing Wipes SWAB TOPICAL 20090905 OTC MONOGRAPH NOT FINAL part333 Cinogen Cosmetics Zhaoqing, LTD. ALCOHOL; TRICLOSAN .62; .003 1/1; 1/1 E 20171231 41900-500_78ec0a6b-2382-42ff-8cb5-40d45576e022 41900-500 HUMAN OTC DRUG Quik Spray Advanced Hand Sanitizing Spray SPRAY TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Cinogen Cosmetics Zhaoqing, LTD. ALCOHOL; TRICLOSAN .62; .03 mL/mL; mL/mL E 20171231 42002-101_a3d4f3d0-402d-48f2-9f2d-578dc79e0ba2 42002-101 HUMAN OTC DRUG Mens Rogaine Extra Strength Minoxidil SOLUTION TOPICAL 20100716 20181201 NDA NDA020834 Johnson & Johnson Consumer Inc. MINOXIDIL 50 mg/mL N 20181231 42002-105_1c98a58a-24e3-4a6b-b0ff-5d86e1b2088d 42002-105 HUMAN OTC DRUG Womens Rogaine - Unscented Minoxidil SOLUTION TOPICAL 20100801 20181201 NDA NDA019501 Johnson & Johnson Consumer Inc. MINOXIDIL 20 mg/mL N 20181231 42002-107_8bd1ce52-4890-46f3-9bc6-0cb2b82bcc60 42002-107 HUMAN OTC DRUG Womens Rogaine Unscented Minoxidil AEROSOL, FOAM TOPICAL 20140922 20180301 NDA NDA021812 Johnson & Johnson Consumer Inc. MINOXIDIL 50 mg/g N 20181231 42002-200_db1f7543-bc7b-4383-b2dc-a25db8b8a5a2 42002-200 HUMAN OTC DRUG Visine A Multi-Action Eye Allergy Relief Naphazoline Hydrochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20101215 NDA NDA020485 Johnson & Johnson Consumer Inc. NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL N 20181231 42002-201_8f67408c-381a-4909-b851-db6160e872f8 42002-201 HUMAN OTC DRUG Visine A.C. Tetrahydrozoline Hydrochloride and Zinc Sulfate SOLUTION/ DROPS OPHTHALMIC 20091101 OTC MONOGRAPH FINAL part349 Johnson & Johnson Consumer Inc. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE, UNSPECIFIED FORM .5; 2.5 mg/mL; mg/mL N 20181231 42002-202_cbc4d607-ba63-4dbf-ba9d-59bee9757840 42002-202 HUMAN OTC DRUG Visine Advanced Relief Dextran 70, Polyethylene Glycol 400, Povidone, and Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20110515 OTC MONOGRAPH FINAL part349 Johnson & Johnson Consumer Inc. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42002-203_edc14e1d-e2c3-48ea-84d8-a4fb8925b610 42002-203 HUMAN OTC DRUG Visine Original Redness Relief Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20091001 OTC MONOGRAPH FINAL part349 Johnson & Johnson Consumer Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 42002-207_2ee86eda-a8ad-4683-b3fa-57017c332533 42002-207 HUMAN OTC DRUG Visine Tears Long Lasting Dry Eye Relief Glycerin, Hypromelloses, and Polyethylene Glycol 400 SOLUTION/ DROPS OPHTHALMIC 20110909 20181001 OTC MONOGRAPH FINAL part349 Johnson & Johnson Consumer Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 3.6; 10 mg/mL; mg/mL; mg/mL N 20181231 42002-209_5a553211-7532-4046-901d-77d9e005937d 42002-209 HUMAN OTC DRUG Visine Totality Multi Symptom Relief Glycerin, Hypromelloses, Polyethylene Glycol 400, Tetrahydrozoline Hydrochloride, and Zinc Sulfate LIQUID OPHTHALMIC 20110823 OTC MONOGRAPH FINAL part349 Johnson & Johnson Consumer Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE, UNSPECIFIED FORM 2.5; 3.6; 11.28; .5; 2.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42002-210_294ef0e5-db08-4373-82a7-c151c24441d4 42002-210 HUMAN OTC DRUG Visine Dry Eye Relief Glycerin, Hypromelloses, and Polyethylene Glycol 400 SOLUTION/ DROPS OPHTHALMIC 20090605 OTC MONOGRAPH FINAL part349 Johnson & Johnson Consumer Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL N 20181231 42002-211_1e4a414e-b54b-4a2f-9c9c-7e0e84b81c93 42002-211 HUMAN OTC DRUG Visine Maximum Strength Redness Relief Formula Glycerin, Hypromelloses, Polyethylene Glycol 400, and Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20110629 OTC MONOGRAPH FINAL part349 Johnson & Johnson Consumer Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE 2; 3.6; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42002-214_cbc4d607-ba63-4dbf-ba9d-59bee9757840 42002-214 HUMAN OTC DRUG Visine Advanced Relief Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hydrochloride KIT 20110603 20180301 OTC MONOGRAPH FINAL part349 Johnson & Johnson Consumer Inc. E 20171231 42002-215_cbc4d607-ba63-4dbf-ba9d-59bee9757840 42002-215 HUMAN OTC DRUG Visine Advanced Relief Dextran 70, Polyethylene Glycol 400, Povidone, Tetrahydrozoline Hydrochloride KIT 20110603 20180301 OTC MONOGRAPH FINAL part349 Johnson & Johnson Consumer Inc. E 20171231 42002-401_ae44b9e0-33dd-423d-9372-59878c690c83 42002-401 HUMAN OTC DRUG Listerine Antiseptic Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20120221 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42002-402_ef983942-3172-40c1-8b5a-a53db1a6397c 42002-402 HUMAN OTC DRUG Listerine Cool Mint Antiseptic Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20120221 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Consumer Inc. EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42002-403_ec52c53e-13e2-4a83-a26b-a6c3ab40cb2c 42002-403 HUMAN OTC DRUG Listerine FreshBurst Antiseptic Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20120221 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Consumer Inc. EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42002-404_b225cc1a-bdb6-445f-a28d-bc1d8c67f8a8 42002-404 HUMAN OTC DRUG Soft Mint Listerine Antiseptic Eucalyptol, Menthol, Methyl Salicylate and Thymol MOUTHWASH DENTAL 20100205 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42002-411_6dc8357c-282f-417f-b491-d473dad8a5ec 42002-411 HUMAN OTC DRUG Listerine Essential Care Sodium Monofluorophosphate GEL, DENTIFRICE ORAL 20120312 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM MONOFLUOROPHOSPHATE 1.3 mg/g N 20181231 42002-416_07164be2-c167-4bca-99d2-3b9917275ab8 42002-416 HUMAN OTC DRUG Listerine Smart Rinse Mint Shield Sodium Fluoride MOUTHWASH ORAL 20120725 OTC MONOGRAPH NOT FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .221 g/mL N 20181231 42002-419_a05dddb1-6330-43c1-b9f6-de18bff0b664 42002-419 HUMAN OTC DRUG Listerine Smart Rinse Phineas and Ferb Bubble Blast Sodium Fluoride MOUTHWASH ORAL 20110201 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .221 g/mL N 20181231 42002-420_78490ae7-f023-495a-8212-1d8e09b966d8 42002-420 HUMAN OTC DRUG Listerine Whitening Restoring Sodium Fluoride RINSE ORAL 20120501 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 42002-421_a63e9217-626f-4d47-a3a4-77406f345df5 42002-421 HUMAN OTC DRUG LISTERINE TOTAL CARE Anticavity - Fresh Mint Sodium fluoride MOUTHWASH DENTAL 20091130 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-423_0bb6a976-39ce-4716-a6b5-760947aa48c2 42002-423 HUMAN OTC DRUG Listerine Total Care Anticavity Cinnamint Sodium Fluoride MOUTHWASH ORAL 20090609 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-427_0efcdbd2-7e58-404b-a88f-4b90e10488c1 42002-427 HUMAN OTC DRUG Listerine Total Care Plus Whitening Sodium Fluoride MOUTHWASH DENTAL 20100701 20180501 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-428_b23cc753-2473-4714-a2d0-04af1e228ecc 42002-428 HUMAN OTC DRUG Listerine Whitening Fluoride Anticavity Original Sodium Monofluorophosphate GEL, DENTIFRICE ORAL 20121112 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 42002-440_ad98c9bb-0e6c-4228-b301-c064afed8f41 42002-440 HUMAN OTC DRUG Rembrandt Intense Stain Brilliant Mint Sodium Fluoride PASTE, DENTIFRICE ORAL 20120316 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 42002-442_c5d0a96b-258b-4210-97ce-1338171941e8 42002-442 HUMAN OTC DRUG Rembrandt Deeply White Plus Peroxide Whitening Fresh Mint Sodium Fluoride MOUTHWASH ORAL 20120316 20180701 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-445_98210b73-4700-44c2-9340-b8237baacbee 42002-445 HUMAN OTC DRUG Listerine Naturals Anticavity - Herbal Mint Sodium Fluoride MOUTHWASH ORAL 20131220 20181001 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-446_4c0f628d-6b02-415c-b9db-9a22309e6bcf 42002-446 HUMAN OTC DRUG Listerine Naturals Antiseptic - Herbal Mint Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20131215 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42002-447_299f327b-49e4-4a54-a226-263935a85a3a 42002-447 HUMAN OTC DRUG Listerine Ultraclean Antiseptic Cool Mint Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20120709 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42002-448_fa7826c1-e40d-44e4-a7f8-7a930c85338d 42002-448 HUMAN OTC DRUG Listerine Ultraclean Antiseptic Arctic Mint Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20120703 OTC MONOGRAPH NOT FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42002-449_3b9f950e-31cf-4acc-8275-d96ee100a7ef 42002-449 HUMAN OTC DRUG Listerine Ultraclean Antiseptic Fresh Citrus Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20120710 OTC MONOGRAPH FINAL part356 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42002-450_be4740c9-e43d-482e-a2a8-40f0e7ebd15f 42002-450 HUMAN OTC DRUG Listerine Fluoride Defense Anticavity mint Shield Sodium Fluoride MOUTHWASH ORAL 20111201 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-506_db97bb8c-3f73-4990-8754-6d45c3012312 42002-506 HUMAN OTC DRUG Listerine Smart Rinse Bubble Gum Shield Sodium Fluoride MOUTHWASH ORAL 20120725 OTC MONOGRAPH NOT FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .221 g/mL N 20181231 42002-507_e8bf5388-5fe1-40bf-a547-17179864a414 42002-507 HUMAN OTC DRUG Listerine Total Care Zero Anticavity Fresh Mint Sodium Fluoride MOUTHWASH ORAL 20120725 20181001 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-508_5f86d98d-ebd2-4639-813c-8078e443fa32 42002-508 HUMAN OTC DRUG Rembrandt Gentle White Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120730 20180701 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE 2.43 mg/g E 20171231 42002-509_90b05b77-9af1-4079-85e2-9c4446f16079 42002-509 HUMAN OTC DRUG Listerine Whitening Anticavity Vibrant - Clean Mint Sodium Fluoride MOUTHWASH ORAL 20131215 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-512_0f8949f9-efb1-4a94-8dcb-a0f74a9d09e9 42002-512 HUMAN OTC DRUG Listerine HealthyWhite Restoring Clean Mint Sodium Fluoride MOUTHWASH ORAL 20140903 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-514_e1bcbea1-5dde-4c0e-812f-2fa9e9df2603 42002-514 HUMAN OTC DRUG Listerine HealthyWhite Anticavity Mouthrinse Vibrant - Clean Mint Sodium Fluoride MOUTHWASH ORAL 20140728 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-516_e38ce313-0014-4ce2-80bf-0f7afea6d5af 42002-516 HUMAN OTC DRUG Listerine Healthy White Anticavity Fluoride Gentle Clean Mint Sodium Fluoride MOUTHWASH ORAL 20140624 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-616_3b45e44c-2ea8-4218-b46a-1664960b7f71 42002-616 HUMAN OTC DRUG Rembrandt Deeply White Plus Peroxide Whitening Winter Mint Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20120316 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g N 20181231 42002-617_4ef0d817-52bc-4206-8f24-1077369df8c4 42002-617 HUMAN OTC DRUG Rembrandt Deeply White Plus Peroxide Whitening Fresh Mint Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20120316 OTC MONOGRAPH FINAL part355 Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g N 20181231 42002-618_11d59552-1472-4a34-ab5b-377e392ecd56 42002-618 HUMAN OTC DRUG Listerine SmartRinse Anticavity Fluoride Rinse Avengers Sodium Fluoride MOUTHWASH ORAL 20140512 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-619_a36cd71f-84bf-47f9-b1ed-2830f724d03d 42002-619 HUMAN OTC DRUG Listerine Smart Anticavity - Frozen Bubble Blast Sodium Fluoride MOUTHWASH ORAL 20141007 20180613 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42002-621_1f62ed35-44a2-4627-a42c-40cbda8d807f 42002-621 HUMAN OTC DRUG Listerine Total Care Stain Remover Anti cavity Freshmint Sodium Fluoride MOUTHWASH DENTAL 20100701 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 42021-030_22c80db8-d103-43a9-9e5b-e3932201b294 42021-030 HUMAN OTC DRUG Clean Acne Salicylic Acid GEL TOPICAL 20141207 OTC MONOGRAPH FINAL part333D Ceela Naturals SALICYLIC ACID 20 mg/mL E 20171231 42021-031_09a3687c-40ac-4567-b214-c56da23ac566 42021-031 HUMAN OTC DRUG Acne Gel Wash Salicylic Acid GEL TOPICAL 20161118 OTC MONOGRAPH FINAL part333D Ceela Naturals SALICYLIC ACID 20 mg/mL N 20181231 42021-032_8e7f5e7b-aea9-46b4-8275-541a890a517f 42021-032 HUMAN OTC DRUG Clear Salve-50 Salicylic Acid SALVE TOPICAL 20170816 OTC MONOGRAPH FINAL part333D Ceela Naturals SALICYLIC ACID 20 mg/mL N 20181231 42021-033_17697363-2644-49f5-a9f9-7df320f37650 42021-033 HUMAN OTC DRUG Clear Salve 150 Salicylic Acid SALVE TOPICAL 20170816 OTC MONOGRAPH FINAL part333D Ceela Naturals SALICYLIC ACID 20 mg/mL N 20181231 42021-034_41e0f3d1-1c48-400d-b64d-04cd8c8455cc 42021-034 HUMAN OTC DRUG Psoriasis Salve Salicylic Acid SALVE TOPICAL 20170816 OTC MONOGRAPH FINAL part333D Ceela Naturals,LLC SALICYLIC ACID 20 mg/mL N 20181231 42021-035_1cc060e2-76f6-4c5c-b668-876477367960 42021-035 HUMAN OTC DRUG 3 Part Acne Treatment Kit Ceela Naturaals SALICYLIC ACID KIT 20171009 OTC MONOGRAPH FINAL 333D Ceela Naturals, LLC N 20181231 42023-104_d8054592-defc-4aa5-9392-700090b9fb20 42023-104 HUMAN PRESCRIPTION DRUG Aplisol Tuberculin Purified Protein Derivative INJECTION INTRADERMAL 20080425 BLA BLA103782 Par Pharmaceutical, Inc. TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU]/.1mL Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [Chemical/Ingredient] N 20181231 42023-105_e387f9d3-5b2e-4359-88ab-1ce750c42c66 42023-105 HUMAN PRESCRIPTION DRUG Brevital Sodium methohexital sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; RECTAL 20071101 NDA NDA011559 Par Pharmaceutical, Inc. METHOHEXITAL SODIUM 500 mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] CIV N 20181231 42023-106_e387f9d3-5b2e-4359-88ab-1ce750c42c66 42023-106 HUMAN PRESCRIPTION DRUG Brevital Sodium methohexital sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; RECTAL 20071101 NDA NDA011559 Par Pharmaceutical, Inc. METHOHEXITAL SODIUM 2.5 g/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] CIV N 20181231 42023-107_8e093e72-e7ad-4fbd-8c17-63e54924ec07 42023-107 HUMAN PRESCRIPTION DRUG Coly-Mycin M colistimethate INJECTION INTRAMUSCULAR; INTRAVENOUS 20071101 NDA NDA050108 Par Pharmaceutical, Inc. COLISTIMETHATE SODIUM 150 mg/2mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 42023-109_0d4ffe34-61c8-4fca-9ef4-e353f2294071 42023-109 HUMAN PRESCRIPTION DRUG Cortisporin-TC colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone acetate SUSPENSION AURICULAR (OTIC) 20071101 NDA NDA050356 Par Pharmaceutical, Inc. COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE 3; 3.3; .5; 10 mg/mL; mg/mL; mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 42023-110_aa0e780e-ec55-4e3d-9167-c1d42f872b37 42023-110 HUMAN PRESCRIPTION DRUG Delestrogen estradiol valerate INJECTION INTRAMUSCULAR 20071101 NDA NDA009402 Par Pharmaceutical, Inc. ESTRADIOL VALERATE 10 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 42023-111_aa0e780e-ec55-4e3d-9167-c1d42f872b37 42023-111 HUMAN PRESCRIPTION DRUG Delestrogen estradiol valerate INJECTION INTRAMUSCULAR 20071101 NDA NDA009402 Par Pharmaceutical, Inc. ESTRADIOL VALERATE 20 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 42023-112_aa0e780e-ec55-4e3d-9167-c1d42f872b37 42023-112 HUMAN PRESCRIPTION DRUG Delestrogen estradiol valerate INJECTION INTRAMUSCULAR 20071101 NDA NDA009402 Par Pharmaceutical, Inc. ESTRADIOL VALERATE 40 mg/mL Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 42023-113_b94ace1b-96b4-4ef9-8632-06e868a2049b 42023-113 HUMAN PRESCRIPTION DRUG Ketalar ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20071001 NDA NDA016812 Par Pharmaceutical, Inc. KETAMINE HYDROCHLORIDE 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 42023-114_b94ace1b-96b4-4ef9-8632-06e868a2049b 42023-114 HUMAN PRESCRIPTION DRUG Ketalar ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20071001 NDA NDA016812 Par Pharmaceutical, Inc. KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 42023-115_b94ace1b-96b4-4ef9-8632-06e868a2049b 42023-115 HUMAN PRESCRIPTION DRUG Ketalar ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20071001 NDA NDA016812 Par Pharmaceutical, Inc. KETAMINE HYDROCHLORIDE 100 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 42023-116_eefde512-c87b-45f3-be2d-9e403df66622 42023-116 HUMAN PRESCRIPTION DRUG Pitocin oxytocin INJECTION INTRAVENOUS 20080201 NDA NDA018261 Par Pharmaceutical, Inc. OXYTOCIN 10 [iU]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] N 20181231 42023-118_1db64ec1-3939-4756-a44b-00c90005ce05 42023-118 HUMAN PRESCRIPTION DRUG Tigan trimethobenzamide hydrochloride INJECTION INTRAMUSCULAR 20080801 NDA NDA017530 Par Pharmaceutical, Inc. TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] N 20181231 42023-119_1db64ec1-3939-4756-a44b-00c90005ce05 42023-119 HUMAN PRESCRIPTION DRUG Tigan trimethobenzamide hydrochloride INJECTION INTRAMUSCULAR 20080801 NDA NDA017530 Par Pharmaceutical, Inc. TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] N 20181231 42023-120_480ffe8b-5e43-45bc-be8b-bc5731cfbe6d 42023-120 HUMAN PRESCRIPTION DRUG Triostat liothyronine sodium INJECTION INTRAVENOUS 20130501 NDA NDA020105 Par Pharmaceutical, Inc. LIOTHYRONINE SODIUM 10 ug/mL l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 42023-121_602f8636-913b-4686-9f3f-b625b44b7a89 42023-121 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate INJECTION SUBCUTANEOUS 20090806 ANDA ANDA077871 JHP Pharmaceuticals LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 42023-123_44e02603-a1bb-439b-9b74-aa90bab5f472 42023-123 HUMAN PRESCRIPTION DRUG Dantrium dantrolene sodium INJECTION INTRAVENOUS 20090420 NDA NDA018264 Par Pharmaceutical, Inc. DANTROLENE SODIUM 20 mg/60mL Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 42023-124_a6e82749-6530-4e20-95a7-45bcd70aba3c 42023-124 HUMAN PRESCRIPTION DRUG Dantrium dantrolene sodium CAPSULE ORAL 20080801 NDA NDA017443 Par Pharmaceutical, Inc. DANTROLENE SODIUM 25 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 42023-125_a6e82749-6530-4e20-95a7-45bcd70aba3c 42023-125 HUMAN PRESCRIPTION DRUG Dantrium dantrolene sodium CAPSULE ORAL 20080801 NDA NDA017443 Par Pharmaceutical, Inc. DANTROLENE SODIUM 50 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 42023-129_8d5cc273-483c-4ba5-9e21-966578a0685c 42023-129 HUMAN PRESCRIPTION DRUG Fluphenazine Decanoate Fluphenazine Decanoate INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20140709 ANDA ANDA203732 Par Pharmaceutical, Inc. FLUPHENAZINE DECANOATE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 42023-131_8bc2cc86-e415-4960-9f43-10729ea553c3 42023-131 HUMAN PRESCRIPTION DRUG Colistimethate colistimethate sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20120601 NDA AUTHORIZED GENERIC NDA050108 Par Pharmaceutical, Inc. COLISTIMETHATE SODIUM 150 mg/2mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 42023-137_91a4fc07-8daa-49ce-b247-1b32ed8ee250 42023-137 HUMAN PRESCRIPTION DRUG ketamine hydrochloride ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20120601 20180506 NDA AUTHORIZED GENERIC NDA016812 Par Pharmaceutical Inc. KETAMINE HYDROCHLORIDE 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 42023-138_91a4fc07-8daa-49ce-b247-1b32ed8ee250 42023-138 HUMAN PRESCRIPTION DRUG ketamine hydrochloride ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20120601 20180429 NDA AUTHORIZED GENERIC NDA016812 Par Pharmaceutical Inc. KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 42023-139_91a4fc07-8daa-49ce-b247-1b32ed8ee250 42023-139 HUMAN PRESCRIPTION DRUG ketamine hydrochloride ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20120601 20180512 NDA AUTHORIZED GENERIC NDA016812 Par Pharmaceutical Inc. KETAMINE HYDROCHLORIDE 100 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 42023-146_54931ef3-54c3-428a-8869-e1225caa417b 42023-146 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140819 ANDA ANDA203972 Par Pharmaceutical, Inc. DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 42023-149_67fde26e-6c43-4a79-bd9f-ec383f964cf4 42023-149 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160826 ANDA ANDA204773 Par Pharmaceutical, Inc. MELPHALAN 50 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 42023-151_4542c741-e291-4488-969e-a86d2f9e2ce9 42023-151 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130304 ANDA ANDA091170 Par Pharmaceutical Companies, Inc. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 42023-157_a58bf27f-6d3b-487b-ae98-4ea759fa2ee6 42023-157 HUMAN PRESCRIPTION DRUG ETHACRYNATE SODIUM ethacrynate sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160519 ANDA ANDA205473 Par Pharmaceutical, Inc. ETHACRYNATE SODIUM 50 mg/50mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 42023-157_c7f6a824-a0f8-47f3-b2c6-58d8e7e68fd8 42023-157 HUMAN PRESCRIPTION DRUG ETHACRYNATE SODIUM ethacrynate sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20150730 ANDA ANDA205473 Par Pharmaceutical, Inc. ETHACRYNATE SODIUM 50 mg/50mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 42023-157_e4271deb-64c5-4253-9303-d77952117df4 42023-157 HUMAN PRESCRIPTION DRUG ETHACRYNATE SODIUM ethacrynate sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160923 ANDA ANDA205473 Par Pharmaceutical, Inc. ETHACRYNATE SODIUM 50 mg/50mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 42023-159_b41cc9d2-6b20-4755-b22e-fe4eda43df22 42023-159 HUMAN PRESCRIPTION DRUG Adrenalin epinephrine INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20130701 NDA NDA204200 Par Pharmaceutical, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 42023-161_7ebde671-a1ae-4b52-9307-f453fb0233c6 42023-161 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium Anhydrous INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20151211 ANDA ANDA205366 Par Pharmaceutical Companies, Inc. LEVOTHYROXINE SODIUM ANHYDROUS 200 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 42023-163_10f01dec-5af0-4b0d-bd58-432954914daa 42023-163 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20130805 ANDA ANDA202163 Par Pharmaceutical Companies, Inc. ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 42023-164_b2ac1cfb-772b-43e4-961b-1f8e33c77661 42023-164 HUMAN PRESCRIPTION DRUG Vasostrict Vasopressin INJECTION INTRAVENOUS 20141112 NDA NDA204485 Par Pharmaceutical, Inc. VASOPRESSIN, UNSPECIFIED 20 [USP'U]/mL N 20181231 42023-167_7133e3cf-682e-4098-867b-66a9185e5c88 42023-167 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130507 ANDA ANDA202571 JHP Pharmaceuticals, LLC. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 42023-168_b41cc9d2-6b20-4755-b22e-fe4eda43df22 42023-168 HUMAN PRESCRIPTION DRUG Adrenalin epinephrine INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20140301 NDA NDA204640 Par Pharmaceutical, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 42023-172_13a3bf58-fdab-42b4-a28b-722a65ae2185 42023-172 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20161028 ANDA ANDA203575 Par Pharmaceutical, Inc. MYCOPHENOLATE MOFETIL 500 mg/20mL Antimetabolite Immunosuppressant [EPC] N 20181231 42023-173_b1223513-dcea-4e25-a5fa-87611ecfe67b 42023-173 HUMAN PRESCRIPTION DRUG Ganciclovir ganciclovir INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170331 ANDA ANDA204950 Par Pharmaceutical, Inc. GANCICLOVIR SODIUM 500 mg/10mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 42023-179_9c9e5e6d-e8eb-48fb-ad1f-73f2d34d21b1 42023-179 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Buprenorphine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20150730 ANDA ANDA206586 Par Pharmaceutical, Inc. BUPRENORPHINE HYDROCHLORIDE .324 mg/mL Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 42023-182_bc2847b7-c783-4ace-9736-5db24449183c 42023-182 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20150601 ANDA ANDA091665 Par Pharmaceutical, Inc. ARGATROBAN 250 mg/2.5mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 42023-188_9806e051-5d81-42ee-bb60-841d711d544e 42023-188 HUMAN PRESCRIPTION DRUG NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE INJECTION INTRAVENOUS 20170426 ANDA ANDA208405 Par Pharmaceutical, Inc. NEOSTIGMINE METHYLSULFATE .5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 42023-189_9806e051-5d81-42ee-bb60-841d711d544e 42023-189 HUMAN PRESCRIPTION DRUG NEOSTIGMINE METHYLSULFATE NEOSTIGMINE METHYLSULFATE INJECTION INTRAVENOUS 20170426 ANDA ANDA208405 Par Pharmaceutical, Inc. NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 42023-190_b2ac1cfb-772b-43e4-961b-1f8e33c77661 42023-190 HUMAN PRESCRIPTION DRUG Vasostrict Vasopressin INJECTION INTRAVENOUS 20170227 NDA NDA204485 Par Pharmaceutical, Inc. VASOPRESSIN, UNSPECIFIED 20 [USP'U]/mL N 20181231 42023-191_1f030cdd-a588-4002-a51c-a7b782b7c8c2 42023-191 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160801 20180930 ANDA ANDA204139 Par Pharmaceutical, Inc. MEROPENEM 500 mg/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20191231 42023-192_1f030cdd-a588-4002-a51c-a7b782b7c8c2 42023-192 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160801 20180531 ANDA ANDA204139 Par Pharmaceutical, Inc. MEROPENEM 1 g/30mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20191231 42023-196_2f07b040-7bb7-4587-9aa0-8f826306f346 42023-196 HUMAN PRESCRIPTION DRUG Corphedra Ephedrine Sulfate INJECTION, SOLUTION INTRAVENOUS 20170216 NDA NDA208943 Par Pharmaceutical, Inc. EPHEDRINE SULFATE 50 mg/mL alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE] N 20181231 42023-201_9d815416-11c9-470e-a82f-89b0bf232e12 42023-201 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110624 NDA NDA202231 Par Pharmaceutical Inc. LEVOTHYROXINE SODIUM ANHYDROUS 100 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 42023-202_9d815416-11c9-470e-a82f-89b0bf232e12 42023-202 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110624 NDA NDA202231 Par Pharmaceutical Inc. LEVOTHYROXINE SODIUM ANHYDROUS 200 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 42023-203_9d815416-11c9-470e-a82f-89b0bf232e12 42023-203 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110624 NDA NDA202231 Par Pharmaceutical Inc. LEVOTHYROXINE SODIUM ANHYDROUS 500 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 42023-216_453fc694-09d2-4f04-9883-6f81eccf3656 42023-216 HUMAN PRESCRIPTION DRUG Ephedrine Sulfate Ephedrine Sulfate INJECTION, SOLUTION INTRAVENOUS 20170216 NDA NDA208943 Par Pharmaceutical, Inc. EPHEDRINE SULFATE 50 mg/mL alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE] N 20181231 42043-120_d63b78b9-7a8e-4140-a5a4-322a2d7f7e94 42043-120 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil TABLET, FILM COATED ORAL 20160915 ANDA ANDA065388 OrchidPharma Inc CEFPODOXIME PROXETIL 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 42043-121_d63b78b9-7a8e-4140-a5a4-322a2d7f7e94 42043-121 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil TABLET, FILM COATED ORAL 20160915 ANDA ANDA065388 OrchidPharma Inc CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 42043-130_89898cc5-082a-4dab-9ea9-12d17093fa98 42043-130 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET, FILM COATED ORAL 20121212 ANDA ANDA091441 OrchidPharma, Inc NARATRIPTAN HYDROCHLORIDE 1 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 42043-131_89898cc5-082a-4dab-9ea9-12d17093fa98 42043-131 HUMAN PRESCRIPTION DRUG Naratriptan Naratriptan TABLET, FILM COATED ORAL 20121212 ANDA ANDA091441 OrchidPharma, Inc NARATRIPTAN HYDROCHLORIDE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 42043-140_5a9428a7-e4e7-46b2-b813-fb52ac9e1ef6 42043-140 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20071212 ANDA ANDA065248 OrchidPharma Inc CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 42043-141_5a9428a7-e4e7-46b2-b813-fb52ac9e1ef6 42043-141 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20080118 ANDA ANDA065248 OrchidPharma Inc CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 42043-142_116886f4-65ba-46cb-ac1f-7c0670b17ebf 42043-142 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20070412 ANDA ANDA065326 OrchidPharma Inc CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 42043-143_116886f4-65ba-46cb-ac1f-7c0670b17ebf 42043-143 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20070412 ANDA ANDA065326 OrchidPharma Inc CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 42043-150_0df554e0-338b-45fa-8c33-279851c271e5 42043-150 HUMAN PRESCRIPTION DRUG Malathion lotion, 0.5% malathion lotion, 0.5% LOTION TOPICAL 20090513 ANDA ANDA078743 Karalex Pharma, LLC, Woodcliff Lake, NJ 07677 MALATHION 5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 42043-160_d3e4f2ff-0aa8-48ee-9c54-9f53e9a4b95e 42043-160 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130801 ANDA ANDA078963 OrchidPharma Inc MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 42043-161_d3e4f2ff-0aa8-48ee-9c54-9f53e9a4b95e 42043-161 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130801 ANDA ANDA078963 OrchidPharma Inc MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 42043-170_5d0a9228-18e6-4bb7-b9e5-58f41fdcb22e 42043-170 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, COATED ORAL 20091120 ANDA ANDA076520 Karalex Pharma LLC FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 42043-171_5d0a9228-18e6-4bb7-b9e5-58f41fdcb22e 42043-171 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, COATED ORAL 20091120 ANDA ANDA076520 Karalex Pharma LLC FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 42043-190_7967f8f4-eba8-4849-a176-944fffa2ee53 42043-190 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110901 ANDA ANDA078526 Karalex Pharma LLC LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42043-191_7967f8f4-eba8-4849-a176-944fffa2ee53 42043-191 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110901 ANDA ANDA078526 Karalex Pharma LLC LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42043-192_7967f8f4-eba8-4849-a176-944fffa2ee53 42043-192 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110901 ANDA ANDA078526 Karalex Pharma LLC LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42043-193_fe7e0c86-8007-4af5-965c-184c6dbce17d 42043-193 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110901 ANDA ANDA090484 Karalex Pharma LLC LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42043-230_70d6cdc2-8ab8-4419-aa4b-61fd3e4b1bb6 42043-230 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20160411 ANDA ANDA065359 OrchidPharma Inc CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 42043-231_70d6cdc2-8ab8-4419-aa4b-61fd3e4b1bb6 42043-231 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20160411 ANDA ANDA065359 OrchidPharma Inc CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 42043-242_fcf386b1-df02-41ba-ab47-ddc92d440639 42043-242 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20151201 ANDA ANDA065309 OrchidPharma Inc CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 42043-250_9340f3c2-890b-44d4-aa34-4c7ddc15215b 42043-250 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140704 ANDA ANDA065418 OrchidPharma Inc CEFDINIR MONOHYDRATE 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 42043-251_9af324e4-5486-4a7f-8fa6-773d27bd028a 42043-251 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20131004 ANDA ANDA065429 OrchidPharma Inc CEFDINIR MONOHYDRATE 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 42043-252_9af324e4-5486-4a7f-8fa6-773d27bd028a 42043-252 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20131004 ANDA ANDA065429 OrchidPharma Inc CEFDINIR MONOHYDRATE 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 42043-262_20fc7180-00fe-49a6-80b1-f1a4ce4809cf 42043-262 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20150819 ANDA ANDA065284 OrchidPharma Inc CEFPROZIL 125 mg/5mL N 20181231 42043-263_20fc7180-00fe-49a6-80b1-f1a4ce4809cf 42043-263 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20150819 ANDA ANDA065284 OrchidPharma Inc CEFPROZIL 250 mg/5mL N 20181231 42043-320_d5ca9d20-03c3-4072-b7fc-006340d4b146 42043-320 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 OrchidPharma Inc ESZOPICLONE 1 mg/1 CIV N 20181231 42043-321_d5ca9d20-03c3-4072-b7fc-006340d4b146 42043-321 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 OrchidPharma Inc ESZOPICLONE 2 mg/1 CIV N 20181231 42043-322_d5ca9d20-03c3-4072-b7fc-006340d4b146 42043-322 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 OrchidPharma Inc ESZOPICLONE 3 mg/1 CIV N 20181231 42043-370_c8357a86-a7b1-4811-9251-5a7c4ef05939 42043-370 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20150320 ANDA ANDA202052 OrchidPharma Inc PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 42043-371_c8357a86-a7b1-4811-9251-5a7c4ef05939 42043-371 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantooprazole Sodium TABLET, DELAYED RELEASE ORAL 20150320 ANDA ANDA202052 OrchidPharma Inc PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 42043-390_cc33e568-5dd3-4dc2-a283-dec9252b4808 42043-390 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET, FILM COATED ORAL 20160412 ANDA ANDA078678 OrchidPharma Inc GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 42046-002_3a805223-101e-4b49-9a6f-a77b127d5d51 42046-002 HUMAN OTC DRUG Arneu Camphor Menthol CREAM TOPICAL 20100828 OTC MONOGRAPH FINAL part341 CC Medical Devices Inc CAMPHOR (NATURAL); MENTHOL 3.1; 3 g/100g; g/100g E 20171231 42068-001_45ed921b-61ef-4d1a-bbda-7fa7fd62f279 42068-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19730101 NDA NDA205767 Jackson Welding Supply Co Inc. OXYGEN 990 mL/L N 20181231 42068-002_8027280d-5591-4917-94d9-c3e5f25a903e 42068-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19730101 NDA NDA205766 Jackson Welding Supply Co Inc. NITROGEN 990 mL/L N 20181231 42069-001_ba39f2d4-1972-45e8-8bdd-bc272adfd3f0 42069-001 HUMAN OTC DRUG Maya Solar Natural Sunscreen 45 SPF SUNSCREEN CREAM TOPICAL 20050225 OTC MONOGRAPH FINAL part352 Batab Health Care S.a. de C.v. ZINC OXIDE; TITANIUM DIOXIDE 9; 1.5 g/100g; g/100g E 20171231 42069-002_ddba3439-a5df-4f5b-8461-3227ecd8ffc7 42069-002 HUMAN OTC DRUG Maya Solar Natural Sunscreen 30 SPF SUNSCREEN CREAM TOPICAL 20050225 OTC MONOGRAPH FINAL part352 Batab Health Care S.a. de C.v. ZINC OXIDE; TITANIUM DIOXIDE 8; 1 g/100g; g/100g E 20171231 42069-003_7bb952d4-0162-4a54-b418-ba8cae65330c 42069-003 HUMAN OTC DRUG Maya Solar Natural Sunscreen 15 SPF SUNSCREEN CREAM TOPICAL 20050225 OTC MONOGRAPH FINAL part352 Batab Health Care S.a. de C.v. ZINC OXIDE; TITANIUM DIOXIDE 7; .5 g/100g; g/100g E 20171231 42086-101_796ced8d-3a21-46bc-8d1e-147cc704bbd0 42086-101 HUMAN OTC DRUG Good to Go Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130427 OTC MONOGRAPH NOT FINAL part333E Jiangsu Gold Worldworks Household Chemicals Co., Ltd. ALCOHOL 62 mL/100mL E 20171231 42126-5200_b0439dd7-d670-4783-b794-721a157b9c44 42126-5200 HUMAN OTC DRUG VISCO SHIELD Lubricant HYPROMELLOSE 2208 (15000 MPA.S) SOLUTION/ DROPS OPHTHALMIC 20140616 OTC MONOGRAPH FINAL part349 OASIS Medical, Inc. HYPROMELLOSE 2208 (15000 MPA.S) 17 mg/mL N 20191231 42126-6100_97d84a3b-1045-4ecb-a14c-c25f75cc9bbe 42126-6100 HUMAN OTC DRUG OASIS Tears Glycerin SOLUTION/ DROPS OPHTHALMIC 20071101 OTC MONOGRAPH FINAL part349 OASIS Medical, Inc. GLYCERIN .2 g/100mL E 20171231 42126-6200_c578028b-e30d-4a33-b7cf-e13b5a45b92c 42126-6200 HUMAN OTC DRUG OASIS Tears Plus Glycerin SOLUTION/ DROPS OPHTHALMIC 20071101 OTC MONOGRAPH FINAL part349 OASIS Medical, Inc. GLYCERIN .2 g/100mL E 20171231 42126-6310_37fdb863-7288-29bc-e054-00144ff8d46c 42126-6310 HUMAN OTC DRUG OASIS Tears Multidose Glycerin SOLUTION/ DROPS OPHTHALMIC 20100109 OTC MONOGRAPH FINAL part349 OASIS Medical, Inc. GLYCERIN 2 g/1000mL N 20181231 42126-6400_38118289-3541-734e-e054-00144ff8d46c 42126-6400 HUMAN OTC DRUG Oasis Tears PF Glycerin SOLUTION/ DROPS OPHTHALMIC 20150101 OTC MONOGRAPH FINAL part349 OASIS Medical, Inc. GLYCERIN .25 g/100mL N 20181231 42139-001_7af033dd-bfce-4814-8eb0-e807ab88f063 42139-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19880101 NDA NDA205767 Seaboard Welding Supply Co., Inc. OXYGEN 99 L/100L N 20181231 42165-0001_df9822b4-05fb-4ae7-b9af-64f834d1933f 42165-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070101 UNAPPROVED MEDICAL GAS Atlanta Medical Gas LLC OXYGEN 99 L/100L E 20171231 42165-0002_df9822b4-05fb-4ae7-b9af-64f834d1933f 42165-0002 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20070101 UNAPPROVED MEDICAL GAS Atlanta Medical Gas LLC OXYGEN 99 L/100L E 20171231 42192-101_610a0286-a711-7e3b-e053-2a91aa0a5d77 42192-101 HUMAN PRESCRIPTION DRUG UREA UREA EMULSION TOPICAL 20101108 UNAPPROVED DRUG OTHER ACELLA PHARMACEUTICALS UREA 50 g/100g N 20181231 42192-103_620ca594-8a2c-e72f-e053-2991aa0a6e52 42192-103 HUMAN PRESCRIPTION DRUG BP Cleansing Wash SODIUM SULFACETAMIDE and SULFUR LIQUID TOPICAL 20080208 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 40 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-104_620b7b44-3d12-608a-e053-2991aa0a8f3c 42192-104 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE and SULFUR Wash SODIUM SULFACETAMIDE and SULFUR LIQUID TOPICAL 20080208 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 10 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-105_13b45320-6394-47c3-b97d-8a0d2cdd34a9 42192-105 HUMAN OTC DRUG BPO benzoyl peroxide GEL TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333D Acella Pharmaceuticals, LLC BENZOYL PEROXIDE 4 mg/100mg N 20181231 42192-110_6108c09a-8415-5d0f-e053-2991aa0a874a 42192-110 HUMAN OTC DRUG BPO Creamy Wash Complete Pack BENZOYL PEROXIDE KIT 20110927 OTC MONOGRAPH FINAL part333D Acella Pharmaceuticals, LLC N 20181231 42192-112_610a3119-4dbe-2e76-e053-2a91aa0a916b 42192-112 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID AEROSOL, FOAM TOPICAL 20100716 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SALICYLIC ACID 6 g/100g N 20181231 42192-113_620b19ba-1dd6-31f8-e053-2991aa0a8492 42192-113 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE - SULFUR CLEANSING PADS SODIUM SULFACETAMIDE, SULFUR SWAB TOPICAL 20100916 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 10; 4 g/100g; g/100g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-115_d694ff1b-66fe-4099-9acf-b14169bd47b2 42192-115 HUMAN PRESCRIPTION DRUG UREA HYDRATING TOPICAL UREA AEROSOL, FOAM TOPICAL 20101109 UNAPPROVED DRUG OTHER Acella Pharmaceuticals UREA 35 g/100g N 20181231 42192-118_620b7b44-3d22-608a-e053-2991aa0a8f3c 42192-118 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate and Pramoxine Hydrochloride Hydrocortisone Acetate and Pramoxine Hydrochloride KIT 20100201 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC N 20191231 42192-121_620b7b44-3d39-608a-e053-2991aa0a8f3c 42192-121 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE - SULFUR WASH SODIUM SULFACETAMIDE, SULFUR LIQUID TOPICAL 20100916 UNAPPROVED DRUG OTHER ACELLA PHARMACEUTICALS SULFACETAMIDE; SULFUR 90; 40 mg/473.2mL; mg/473.2mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-125_612a249a-6c77-4d78-e053-2a91aa0a4eec 42192-125 HUMAN PRESCRIPTION DRUG BPO 6 Foaming BENZOYL PEROXIDE CLOTH TOPICAL 20100818 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC BENZOYL PEROXIDE 3.2 g/100g N 20181231 42192-129_620b7b44-3d60-608a-e053-2991aa0a8f3c 42192-129 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE SODIUM SULFACETAMIDE LIQUID TOPICAL 20101214 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-130_620b16ea-728c-2c3c-e053-2a91aa0a61cf 42192-130 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID AEROSOL, FOAM TOPICAL 20110427 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SALICYLIC ACID 6 g/100g N 20191231 42192-133_620b16ea-7278-2c3c-e053-2a91aa0a61cf 42192-133 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide and Sulfur Sodium Sulfacetamide and Sulfur SOLUTION TOPICAL 20110727 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 80; 40 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-134_620baf55-4916-b099-e053-2a91aa0a8566 42192-134 HUMAN PRESCRIPTION DRUG Salicylic Acid SALICYLIC ACID GEL TOPICAL 20110519 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SALICYLIC ACID 60 mg/g N 20191231 42192-135_63555e88-6297-449f-be27-39f708365867 42192-135 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID LIQUID TOPICAL 20110921 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SALICYLIC ACID 275 mg/mL N 20181231 42192-136_620d8ee1-1109-d9ac-e053-2a91aa0afef1 42192-136 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 10 Sulfur 5 Cleanser Sulfacetamide Sodium and Sulfur RINSE TOPICAL 20100916 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 10; 5 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-139_620b7b44-3d4b-608a-e053-2991aa0a8f3c 42192-139 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE, SULFUR Sodium Sulfacetamide and Sulfur CREAM TOPICAL 20110727 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-140_620cfd1d-5d28-486e-e053-2a91aa0a6fea 42192-140 HUMAN PRESCRIPTION DRUG Lidocaine HCl and Hydrocortisone Acetate Lidocaine Hydrochloride and Hydrocortisone Acetate CREAM TOPICAL 20110218 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 30; 5 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 42192-143_2c15c998-367e-4699-bac4-97c089f09f50 42192-143 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam Sulfacetamide Sodium and Sulfur AEROSOL, FOAM TOPICAL 20110208 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 10; 5 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-143_8b1d824b-fd04-414e-abf3-542902d2c6e0 42192-143 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam Sulfacetamide Sodium and Sulfur AEROSOL, FOAM TOPICAL 20110208 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 10; 5 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-144_620b349c-eb25-68e2-e053-2991aa0ac08d 42192-144 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 9 Sulfur 4.5 Wash Sulfacetamide Sodium and Sulfur RINSE TOPICAL 20110720 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 9; 4.5 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-146_620baf55-492c-b099-e053-2a91aa0a8566 42192-146 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide Sodium Sulfacetamide GEL TOPICAL 20101214 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-147_620baf55-4944-b099-e053-2a91aa0a8566 42192-147 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 10 Sulfur 2 Cleanser Sulfacetamide Sodium and Sulfur SOLUTION TOPICAL 20080208 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-149_620b7b44-3d4b-608a-e053-2991aa0a8f3c 42192-149 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE, SULFUR Sodium Sulfacetamide and Sulfur CREAM TOPICAL 20110727 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-150_620baf55-495a-b099-e053-2a91aa0a8566 42192-150 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 10 Sulfur 2 cream Sulfacetamide Sodium and Sulfur CREAM TOPICAL 20080208 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-151_620d19f7-ed91-1e50-e053-2991aa0a879c 42192-151 HUMAN PRESCRIPTION DRUG HYDROQUINONE 4% Hydroquinone CREAM TOPICAL 20110117 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20191231 42192-152_6dd86583-724b-408c-ba4e-568db652cf6c 42192-152 HUMAN PRESCRIPTION DRUG Selenium Sulfide Selenium Sulfide SHAMPOO TOPICAL 20080601 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SELENIUM SULFIDE 22.5 mg/mL N 20181231 42192-156_7a15eeda-bc83-4fac-9cc8-ccc854b18e49 42192-156 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser SULFACETAMIDE SODIUM, SULFUR LIQUID TOPICAL 20110208 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 42192-320_9f4ce551-7a80-4ddb-a014-95c44b54a420 42192-320 HUMAN PRESCRIPTION DRUG PNV-Select VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE and CUPRIC OXIDE, TABLET, FILM COATED ORAL 20091102 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE 2500; 80; 400; 10; 3; 3.4; 20; 20; 1; 12; 300; 6; 120; 27; 150; 30; 15; 2 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 42192-320_b6d79552-e6e8-4df2-a9f5-2e5e8a9c47e6 42192-320 HUMAN PRESCRIPTION DRUG PNV-Select VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE and CUPRIC OXIDE TABLET, FILM COATED ORAL 20150805 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE 2500; 80; 400; 10; 3; 3.4; 20; 20; 1; 12; 300; 6; 120; 27; 150; 30; 15; 2 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 42192-321_620d0a13-cc62-6987-e053-2a91aa0a0690 42192-321 HUMAN PRESCRIPTION DRUG PNV-DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent CAPSULE, GELATIN COATED ORAL 20091102 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM; FERROUS FUMARATE; MAGNESIUM; DOCONEXENT 85; 200; 10; 25; 1; 12; 140; 27; 45; 300 [iU]/1; [iU]/1; [iU]/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20191231 42192-323_39e68bdf-f213-48e1-b91c-da785830b21b 42192-323 HUMAN PRESCRIPTION DRUG PNV-DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, calcium, ferrous fumarate, doconexent CAPSULE, GELATIN COATED ORAL 20100930 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC ASCORBIC ACID; CALCIUM; FERROUS FUMARATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE; FOLIC ACID; DOCONEXENT 28; 160; 27; 400; 30; 25; 1.25; 300 mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20191231 42192-327_620d0a13-cc76-6987-e053-2a91aa0a0690 42192-327 HUMAN PRESCRIPTION DRUG NP Thyroid 15 LEVOTHYROXINE, LIOTHYRONINE TABLET ORAL 20101111 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 9.5; 2.25 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20191231 42192-328_d88fe901-b775-4ddd-ae17-8e122a52d03f 42192-328 HUMAN PRESCRIPTION DRUG NP Thyroid 120 LEVOTHYROXINE, LIOTHYRONINE TABLET ORAL 20101111 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 76; 18 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 42192-329_610a0286-a6f8-7e3b-e053-2a91aa0a5d77 42192-329 HUMAN PRESCRIPTION DRUG NP Thyroid 30 LEVOTHYROXINE, LIOTHYRONINE TABLET ORAL 20101111 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 19; 4.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 42192-330_6108c09a-8427-5d0f-e053-2991aa0a874a 42192-330 HUMAN PRESCRIPTION DRUG NP Thyroid 60 LEVOTHYROXINE, LIOTHYRONINE TABLET ORAL 20101111 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 38; 9 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 42192-331_610a0286-a6df-7e3b-e053-2a91aa0a5d77 42192-331 HUMAN PRESCRIPTION DRUG NP Thyroid 90 LEVOTHYROXINE, LIOTHYRONINE TABLET ORAL 20101111 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 57; 13.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 42192-338_5b3276d6-11a4-db29-e053-2991aa0a4dfa 42192-338 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate ODT hyoscyamine sulfate TABLET, ORALLY DISINTEGRATING ORAL 20110519 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 42192-339_5b35609b-f367-d0f3-e053-2991aa0a9fac 42192-339 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate SL hyoscyamine sulfate TABLET SUBLINGUAL 20110519 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 42192-340_5b368f6f-06f5-3e68-e053-2a91aa0a6286 42192-340 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate TAB hyoscyamine sulfate TABLET ORAL 20110519 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 42192-341_c8376318-7d1e-4719-a19e-39e3c120b7b4 42192-341 HUMAN PRESCRIPTION DRUG Prenaissance CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM and DOCONEXENT CAPSULE, LIQUID FILLED ORAL 20110519 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC ASCORBIC ACID; TRICALCIUM PHOSPHATE; FERROUS FUMARATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, D-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; DOCONEXENT; DOCUSATE SODIUM 28; 160; 29; 800; 30; 25; 1.25; 325; 55 mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 42192-343_e46a2830-30d6-4a88-8a62-336b990f2eea 42192-343 HUMAN PRESCRIPTION DRUG Prenaissance Plus CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM and DOCONEXENT CAPSULE, LIQUID FILLED ORAL 20110912 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; DOCUSATE SODIUM; DOCONEXENT 100; 28; 400; 30; 25; 1; 50; 250 mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 42192-365_620bb039-d254-a3fb-e053-2a91aa0acc84 42192-365 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20110516 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SALSALATE 500 mg/1 N 20191231 42192-366_620bb039-d254-a3fb-e053-2a91aa0acc84 42192-366 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20110516 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC SALSALATE 750 mg/1 N 20191231 42192-605_89c236e2-91f6-442c-a5b4-352116e83cf5 42192-605 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20140211 ANDA ANDA202436 Acella Pharmaceuticals TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 42192-607_5b23a410-18e1-b8d7-e053-2a91aa0ae330 42192-607 HUMAN PRESCRIPTION DRUG Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide SYRUP ORAL 20160921 ANDA ANDA203375 Acella Pharmaceuticals, LLC BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 2; 30; 10 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] N 20181231 42192-608_5b2305df-d46e-6506-e053-2a91aa0a9069 42192-608 HUMAN PRESCRIPTION DRUG Gabapentin gabapentin SOLUTION ORAL 20121001 ANDA ANDA076403 Acella Pharmaceuticals, LLC GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 42192-612_5b24710c-b2d2-46bc-e053-2a91aa0a8535 42192-612 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Chlorpheniramine Maleate Hydrocodone Bitartrate and Chlorpheniramine Maleate SOLUTION ORAL 20170614 ANDA ANDA206891 Acella Pharmaceuticals, LLC HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE 5; 4 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII N 20181231 42192-705_814d7c39-a917-43c3-bb6b-efce322607e0 42192-705 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox KIT 20090701 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC N 20181231 42192-706_620d952f-2f1e-dc31-e053-2a91aa0a0f67 42192-706 HUMAN PRESCRIPTION DRUG Calcium Folic Acid Plus D Chewable cholecalciferol, magnesium, boron, folic acid, pyridoxine, cyanocobalamin WAFER ORAL 20100323 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC CALCIUM CARBONATE; CHOLECALCIFEROL; MAGNESIUM; BORON; FOLIC ACID; PYRIDOXINE; CYANOCOBALAMIN 1342; 300; 50; 250; 1; 10; 125 mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; ug/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20191231 42192-714_620c32aa-ccb8-0507-e053-2a91aa0aa177 42192-714 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox KIT 20110912 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC N 20191231 42192-801_620d348d-75a7-3d1a-e053-2991aa0a855f 42192-801 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20110818 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20191231 42192-802_620d348d-75a7-3d1a-e053-2991aa0a855f 42192-802 HUMAN PRESCRIPTION DRUG PHENAZOPYRIDINE HYDROCHLORIDE Phenazopyridine Hydrochloride TABLET ORAL 20110818 UNAPPROVED DRUG OTHER Acella Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20191231 42195-015_10cd6b51-2669-4643-a39c-1c8913eba5d9 42195-015 HUMAN PRESCRIPTION DRUG Dexamethasone DEXAMETHASONE TABLET ORAL 20170911 ANDA ANDA088237 Xspire Pharma, LLC DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 42195-100_798ed441-bb33-4659-94c8-acb60f068686 42195-100 HUMAN PRESCRIPTION DRUG Fenoprofen Calcium fenoprofen calcium CAPSULE ORAL 20160519 NDA AUTHORIZED GENERIC NDA017604 Xspire Pharma FENOPROFEN CALCIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42195-121_41757ac8-d743-4c74-a3fb-5236944b4a45 42195-121 HUMAN PRESCRIPTION DRUG TaperDex 6-day DEXAMETHASONE TABLET ORAL 20180119 ANDA ANDA088237 Xspire Pharma, Llc DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 42195-149_b63df3d4-f98b-41f3-b208-e1bd25655834 42195-149 HUMAN PRESCRIPTION DRUG TaperDex 12-day DEXAMETHASONE TABLET ORAL 20180119 ANDA ANDA088237 Xspire Pharma, Llc DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 42195-150_4693e947-51c0-4df0-9d9e-697fcd346ca8 42195-150 HUMAN PRESCRIPTION DRUG ZoDex DEXAMETHASONE TABLET ORAL 20170816 ANDA ANDA088237 Xspire Pharma, Llc DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 42195-210_1a2fa993-80df-48f6-b10f-1620b8204e45 42195-210 HUMAN OTC DRUG Pyrilamine Maleate and Phenylephrine Hydrochloride Pyrilamine Maleate and Phenylephrine Hydrochloride TABLET ORAL 20131028 OTC MONOGRAPH FINAL part341 Xspire Pharma LLC PYRILAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 25; 10 mg/1; mg/1 N 20181231 42195-308_bea05ded-e206-42f5-a38a-0f31cd2dacde 42195-308 HUMAN PRESCRIPTION DRUG Nalfon fenoprofen calcium CAPSULE ORAL 20120827 NDA NDA017604 Xspire Pharma FENOPROFEN CALCIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42195-550_d0125acf-1879-452d-ba29-c0f753653789 42195-550 HUMAN PRESCRIPTION DRUG Ciprofloxacin Otic CIPROFLOXACIN SOLUTION/ DROPS AURICULAR (OTIC) 20120827 NDA NDA021918 Xspire Pharma CIPROFLOXACIN HYDROCHLORIDE .5 mg/.25mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 42195-600_bea05ded-e206-42f5-a38a-0f31cd2dacde 42195-600 HUMAN PRESCRIPTION DRUG Nalfon fenoprofen calcium CAPSULE ORAL 20120827 NDA NDA017604 Xspire Pharma FENOPROFEN CALCIUM 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42195-840_724970d8-1756-4eb8-8a1e-e3dc9d9895f9 42195-840 HUMAN PRESCRIPTION DRUG Acetaminophen, Caffeine, Dihydrocodeine Bitartrate Acetaminophen, Caffeine, Dihydrocodeine Bitartrate CAPSULE ORAL 20150805 ANDA ANDA204785 XSPIRE PHARMA LLC ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 320.5; 30; 16 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 42195-955_60b30277-9dac-b949-e053-2991aa0a787e 42195-955 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine CAPSULE ORAL 20170804 ANDA ANDA206615 Xspire Pharma, LLC CAFFEINE; BUTALBITAL; ACETAMINOPHEN 40; 50; 300 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 42199-002_ced869ee-565c-4f0c-957c-092b6632dd21 42199-002 HUMAN OTC DRUG Beyond Antiseptic Mouthwash Cetylpyridinium Chloride, Sodium Fluoride LIQUID DENTAL 20071005 OTC MONOGRAPH NOT FINAL part356 BEYOND TECHNOLOGY CORP. CETYLPYRIDINIUM CHLORIDE; SODIUM FLUORIDE .1; .05 mg/mL; mg/mL E 20171231 42199-005_4b897d6f-13a1-487f-9aa1-1ee48fd787ab 42199-005 HUMAN OTC DRUG Pearl White Potassium nitrate, Sodium fluoride PASTE, DENTIFRICE DENTAL 20071005 OTC MONOGRAPH NOT FINAL part356 BEYOND TECHNOLOGY CORP. POTASSIUM NITRATE; SODIUM FLUORIDE .05; .1 mg/g; mg/g E 20171231 42199-006_51c79544-9535-5863-e054-00144ff8d46c 42199-006 HUMAN OTC DRUG Pearl White Potassium nitrate, Sodium fluoride PASTE, DENTIFRICE DENTAL 20170612 OTC MONOGRAPH NOT FINAL part356 Beyond International Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1 mg/g; mg/g N 20181231 42209-1995_ce73e41e-2b80-4644-b419-94163a8f2826 42209-1995 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS ITC Medical Supplies OXYGEN 99 L/100L E 20171231 42211-101_fb061735-4609-4bdf-8c1c-a9669c3bceb6 42211-101 HUMAN PRESCRIPTION DRUG INDOCIN indomethacin SUSPENSION ORAL 19851010 NDA NDA018332 Iroko Pharmaceuticals, LLC INDOMETHACIN 25 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42211-102_6dcc328c-8a87-d981-1460-4fcdee50bfe2 42211-102 HUMAN PRESCRIPTION DRUG INDOCIN INDOMETHACIN SUPPOSITORY RECTAL 19920831 ANDA ANDA073314 Iroko Pharmaceuticals, LLC INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42211-201_92987f9f-31c5-49ba-8b73-a2308ec9262f 42211-201 HUMAN PRESCRIPTION DRUG Tivorbex indomethacin CAPSULE ORAL 20150706 NDA NDA204768 Iroko Pharmaceuticals, LLC INDOMETHACIN 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42211-202_92987f9f-31c5-49ba-8b73-a2308ec9262f 42211-202 HUMAN PRESCRIPTION DRUG Tivorbex indomethacin CAPSULE ORAL 20150706 NDA NDA204768 Iroko Pharmaceuticals, LLC INDOMETHACIN 40 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42211-203_e2d6204c-751c-4ecf-beca-bf7b79bd75a6 42211-203 HUMAN PRESCRIPTION DRUG Zorvolex diclofenac CAPSULE ORAL 20131031 NDA NDA204592 Iroko Pharmaceuticals LLC DICLOFENAC 18 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42211-204_e2d6204c-751c-4ecf-beca-bf7b79bd75a6 42211-204 HUMAN PRESCRIPTION DRUG Zorvolex diclofenac CAPSULE ORAL 20131031 NDA NDA204592 Iroko Pharmaceuticals LLC DICLOFENAC 35 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42211-205_48832d12-37e4-454d-816d-38a8c5e104eb 42211-205 HUMAN PRESCRIPTION DRUG Vivlodex meloxicam CAPSULE ORAL 20151031 NDA NDA207233 Iroko Pharmaceuticals, LLC MELOXICAM 5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42211-206_48832d12-37e4-454d-816d-38a8c5e104eb 42211-206 HUMAN PRESCRIPTION DRUG Vivlodex meloxicam CAPSULE ORAL 20151031 NDA NDA207233 Iroko Pharmaceuticals, LLC MELOXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42213-042_d97df965-4870-436c-9b94-9d9804792a2d 42213-042 HUMAN OTC DRUG Advanced Petrolatum petrolatum OINTMENT TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part347 Ultra Seal Corporation PETROLATUM 1 g/g N 20181231 42213-160_81e0f007-afbd-4167-b448-9d087d000e0d 42213-160 HUMAN OTC DRUG Ultra Tuss guaifenesin SYRUP ORAL 20120619 OTC MONOGRAPH FINAL part341 Ultra Seal Corporation GUAIFENESIN 100 mg/5mL N 20181231 42213-161_837bf4fe-8cb0-43be-9b9c-8801996475c0 42213-161 HUMAN OTC DRUG Ultra Tuss DM guaifenesin dextromethorphan HBr SYRUP ORAL 20120619 OTC MONOGRAPH FINAL part341 Ultra Seal Corporation GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 42213-162_d8d9af92-9ed2-451a-93a3-b3747b281fc2 42213-162 HUMAN OTC DRUG Ultra Tuss Safe guaifenesin dextromethorphan HBr SYRUP ORAL 20120619 OTC MONOGRAPH FINAL part341 Ultra Seal Corporation GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 42213-360_0924012d-38e7-4dc5-8998-45807b8d4368 42213-360 HUMAN OTC DRUG ULTRA SEAL Triple Antibiotic neomycin, polymixin, bacitracin OINTMENT TOPICAL 20110412 OTC MONOGRAPH FINAL part333B Ultra Seal Corporation NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 5; 5000; 400 mg/g; [iU]/g; [iU]/g N 20181231 42213-365_dc08c11b-2623-4c2c-a8e1-44d464bdd4af 42213-365 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20120503 OTC MONOGRAPH NOT FINAL part347 Ultra Seal Corporation ZINC OXIDE 200 mg/g N 20181231 42213-370_315472a4-d04d-4c1c-bb52-71521e68a08d 42213-370 HUMAN OTC DRUG Advanced Hydrocortisone hydrocortisone CREAM TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part348 Ultra Seal Corporation HYDROCORTISONE 10 mg/g N 20181231 42213-375_9765bca5-dce9-46d3-b668-5bb9403003ba 42213-375 HUMAN OTC DRUG Advanced Relief A and D Petrolatum OINTMENT TOPICAL 20111201 OTC MONOGRAPH FINAL part347 Ultra Seal Corporation PETROLATUM 937.5 mg/g N 20181231 42213-400_0a9060d2-613d-40b9-ba98-7dffc5a29851 42213-400 HUMAN OTC DRUG Ultra Seal Bacitracin BACITRACIN ZINC OINTMENT TOPICAL 20111204 OTC MONOGRAPH FINAL part333B Ultra Seal Corporation BACITRACIN ZINC 500 [iU]/g N 20181231 42217-100_6df80051-a6eb-4d58-9670-496ec1c6bebd 42217-100 HUMAN OTC DRUG TONG LUO QU TONG GAO CAMPHOR AND MENTHOL POULTICE TRANSDERMAL 20100602 OTC MONOGRAPH NOT FINAL part348 HENAN LINGRUI PHARMACEUTICAL CO LTD CAMPHOR (NATURAL); MENTHOL 5; 3.4 g/1; g/1 E 20171231 42217-200_823a4603-d2cd-416c-86c4-d50c3f53a439 42217-200 HUMAN OTC DRUG TONG LUO QU TONG GAO CAMPHOR, MENTHOL PLASTER TRANSDERMAL 20100602 OTC MONOGRAPH NOT FINAL part348 Henan Lingrui Pharmaceutical Co.; Ltd CAMPHOR (NATURAL); MENTHOL 5; 3.4 g/100g; g/100g E 20171231 42217-201_23666d8f-e4f9-4331-b50e-78c86bb9efd4 42217-201 HUMAN OTC DRUG Shang Shi Zhi Tong Gao Camphor, Menthol, Methyl Salicylate PLASTER TRANSDERMAL 20100602 OTC MONOGRAPH NOT FINAL part348 Henan Lingrui Pharmaceutical Co.; Ltd CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3; 1.5; 2.5 g/100g; g/100g; g/100g E 20171231 42217-203_7cfda1fe-41e0-4e20-832f-94048ad8dda9 42217-203 HUMAN OTC DRUG Zhuang Gu She Xiang Zhi Tong Gao Camphor, Menthol PLASTER TRANSDERMAL 20100602 OTC MONOGRAPH NOT FINAL part348 Henan Lingrui Pharmaceutical Co.; Ltd CAMPHOR (NATURAL); MENTHOL 3; 2.9 g/100g; g/100g E 20171231 42217-204_68e028fb-2d3c-4df0-8d62-d74bf277091f 42217-204 HUMAN OTC DRUG La Jiao Feng Shi Gao Menthol PLASTER TRANSDERMAL 20100602 OTC MONOGRAPH NOT FINAL part348 Henan Lingrui Pharmaceutical Co Ltd MENTHOL 3 g/100g E 20171231 42217-205_499a0613-2d47-46ad-afae-12b38dbde14b 42217-205 HUMAN OTC DRUG Joint Analgesic Plaster Camphor PLASTER TRANSDERMAL 20100602 OTC MONOGRAPH NOT FINAL part348 Henan Lingrui Pharmaceutical Co Ltd CAMPHOR (SYNTHETIC) 3 g/100g E 20171231 42217-206_447c97f3-b4a3-4a5d-9498-6e25f83665f7 42217-206 HUMAN OTC DRUG Pain Relief Tincture Camphor, Menthol TINCTURE TOPICAL 20100602 OTC MONOGRAPH NOT FINAL part348 Henan Lingrui Pharmaceutical Co Ltd CAMPHOR (SYNTHETIC); MENTHOL 5; 1.3 g/100mL; g/100mL E 20171231 42217-207_2c9bf917-0fbc-433a-894c-7ebbf471d87e 42217-207 HUMAN OTC DRUG Pain Relieving Camphor, Menthol SPRAY TOPICAL 20100602 OTC MONOGRAPH NOT FINAL part348 Henan Lingrui Pharmaceutical Co Ltd CAMPHOR (SYNTHETIC); MENTHOL 11; 16 g/100mL; g/100mL E 20171231 42217-208_6087699f-4ee3-4ddd-ab0c-537b46c7645e 42217-208 HUMAN OTC DRUG Fu Er Jie TRICLOSAN LOTION VAGINAL 20100602 OTC MONOGRAPH NOT FINAL part333A Henan Lingrui Pharmaceutical Co Ltd TRICLOSAN .12 g/100g E 20171231 42217-300_3afcd2bf-94f7-11c9-e054-00144ff8d46c 42217-300 HUMAN OTC DRUG Eagle Menthol Capsaicin PATCH TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part348 Henan Lingrui Pharmaceutical Co Ltd CAPSAICIN; MENTHOL .0625; 3.4 g/1; g/1 N 20181231 42221-0001_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0001 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0002_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0002 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0003_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0003 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0004_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0004 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0005_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0005 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0006_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0006 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0007_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0007 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0008_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0008 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0009_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0009 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0010_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0010 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0011_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0011 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0012_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0012 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0013_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0013 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42221-0014_d7b58d6d-6a4c-417d-93d3-607b4334af2f 42221-0014 HUMAN OTC DRUG MANGO BUTTER LIPSTICK SPF 10 Avobenzone and Octinoxate LIPSTICK TOPICAL 20100830 OTC MONOGRAPH NOT FINAL part352 ART COSMETICS SRL AVOBENZONE; OCTINOXATE 2; 6 g/100g; g/100g E 20171231 42227-081_d8d6b428-017e-4236-8a49-931ae1d939ae 42227-081 PLASMA DERIVATIVE Cinryze HUMAN C1-ESTERASE INHIBITOR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081201 BLA BLA125267 ViroPharma Biologics HUMAN C1-ESTERASE INHIBITOR 500 [iU]/5mL Human C1 Esterase Inhibitor [EPC],Decreased Vascular Permeability [PE],Kallikrein Inhibitors [MoA] N 20191231 42238-111_af666b46-d055-41ba-914f-fc7bb71019f3 42238-111 HUMAN PRESCRIPTION DRUG ACTIMMUNE Interferon gamma-1b INJECTION, SOLUTION SUBCUTANEOUS 20131201 BLA BLA103836 HZNP USA, Inc. INTERFERON GAMMA-1B 100 ug/.5mL Interferon gamma [EPC],Interferon-gamma [Chemical/Ingredient] N 20181231 42241-001_2ae8da74-9cac-402d-8980-ab9b477cb9bf 42241-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20111101 NDA NDA205767 - INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC. OXYGEN 995 mL/L N 20181231 42241-002_d7742f6e-7959-43d3-9ba1-2fd1c259cc94 42241-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20111101 NDA NDA205766 INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC. NITROGEN 995 mL/L N 20181231 42248-101_a92c28f0-6829-455d-b4fc-2bacb6f346db 42248-101 HUMAN OTC DRUG Hydromarine Extreme OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL E 20171231 42248-102_1a50face-9868-4e0a-ad0f-72d68dd8416f 42248-102 HUMAN OTC DRUG Anti Aging Star OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL E 20171231 42248-103_b8142397-d9f0-4fdb-a542-46731e3b7b7d 42248-103 HUMAN OTC DRUG Vita K OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL E 20171231 42248-104_b769397d-8e80-4d92-9e25-60301a2b4f54 42248-104 HUMAN OTC DRUG Calcium Repair OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL E 20171231 42248-105_40e4fb62-5109-4acb-8ba5-ebc8e3c76fb0 42248-105 HUMAN OTC DRUG Retin C OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL E 20171231 42248-106_0005afe5-6eb3-4eea-baee-21c117b4528b 42248-106 HUMAN OTC DRUG Expression Marine OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL E 20171231 42248-107_76b70628-b13f-4273-ac4b-c773c289d8ca 42248-107 HUMAN OTC DRUG Regemarine Extreme OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL E 20171231 42248-108_3d7512ce-c32f-4f7f-aea4-ecfa459d7881 42248-108 HUMAN OTC DRUG Seborrheic Purifying OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL E 20171231 42248-109_f5c09f39-a618-4b42-860f-a9fe64b0f9eb 42248-109 HUMAN OTC DRUG Drymarine Age Control OCTINOXATE, TITANIUM DIOXIDE, AVOBENZONE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE 3.75; 12.5; 1.5 mL/50mL; mL/50mL; mL/50mL E 20171231 42248-110_fba51ef7-8b81-4b54-9707-b2c75667b4a5 42248-110 HUMAN OTC DRUG Hydromarine Extreme OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL E 20171231 42248-111_3d1bfec3-7f57-4160-9aae-a3497b0abf86 42248-111 HUMAN OTC DRUG La Creme Plus OCTINOXATE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 3.75 mL/50mL E 20171231 42248-112_2271626b-8be0-483f-a6a3-5b9f5176f40b 42248-112 HUMAN OTC DRUG Regemarine Extreme OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL E 20171231 42248-113_f5e66a01-b75c-466e-bcde-e8fe31456ed3 42248-113 HUMAN OTC DRUG Anti Aging Star OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL E 20171231 42248-114_df501bee-7bbd-4945-99c8-fb774f63ea50 42248-114 HUMAN OTC DRUG Retin C OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL E 20171231 42248-115_791d0768-1857-417d-a41c-6d8f4922b8b6 42248-115 HUMAN OTC DRUG Expression Marine OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL E 20171231 42248-116_bf9ac16a-ea55-4129-8da4-fd0420d08865 42248-116 HUMAN OTC DRUG Calcium Repair OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL E 20171231 42248-117_dcacb642-3435-4ed8-b0c6-c26d68b7588c 42248-117 HUMAN OTC DRUG Seborrheic Purifying OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL E 20171231 42248-118_f37ded20-5c9c-4562-bae2-3424e5c135ea 42248-118 HUMAN OTC DRUG Vita K OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 15 mL/200mL E 20171231 42248-120_0b905f54-76b6-4b1f-8655-b4e7f11a3da1 42248-120 HUMAN OTC DRUG Sun Care For Face OCTINOXATE AVOBENZONE ZINC OXIDE OCTOCRYLENE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; AVOBENZONE; ZINC OXIDE; OCTOCRYLENE 4.5; 1.8; 14.4; 4.5 mL/60mL; mL/60mL; mL/60mL; mL/60mL E 20171231 42248-121_46664fc4-6c03-4e9f-8b9a-0159dcb0bdd8 42248-121 HUMAN OTC DRUG Sun Care For Face OCTINOXATE AVOBENZONE ZINC OXIDE OCTOCRYLENE EMULSION TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; AVOBENZONE; ZINC OXIDE; OCTOCRYLENE 4.5; 1.8; 14.4; 4.5 mL/60mL; mL/60mL; mL/60mL; mL/60mL E 20171231 42248-122_74295561-d8ee-4030-9409-70896625be7c 42248-122 HUMAN OTC DRUG SUN CARE FOR BODY OCTINOXATE AVOBENZONE ZINC OXIDE OCTOCRYLENE EMULSION TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; AVOBENZONE; ZINC OXIDE; OCTOCRYLENE 11.25; 4.5; 36; 15 mL/150mL; mL/150mL; mL/150mL; mL/150mL E 20171231 42248-123_19baf3b8-1601-4a11-a5dc-b4141882d5f8 42248-123 HUMAN OTC DRUG Drymarine Age Control OCTINOXATE, TITANIUM DIOXIDE, AVOBENZONE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE 15; 50; 6 mL/200mL; mL/200mL; mL/200mL E 20171231 42248-124_7525f0f3-d258-4f96-9566-309ffb91176b 42248-124 HUMAN OTC DRUG Protector R Plus OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE 15; 50; 12 mL/200mL; mL/200mL; mL/200mL E 20171231 42248-125_ed471670-2e13-4e44-8a0a-09a095c5a57c 42248-125 HUMAN OTC DRUG Hyaluronic Filler Serum OCTINOXATE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 2.25 mL/30mL E 20171231 42248-126_048f292f-30de-4686-a9a8-fe4cb240ee1d 42248-126 HUMAN OTC DRUG Silky Finish Fluid OCTINOXATE LOTION TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 1.125 mL/15mL E 20171231 42248-127_c1540d77-5935-458f-b238-50e2e49b57cf 42248-127 HUMAN OTC DRUG Protector R Plus OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE 3.75; 12.5; 3 mL/50mL; mL/50mL; mL/50mL E 20171231 42248-128_8c1dcf29-11ed-40f8-a0e9-efcb9dbd6417 42248-128 HUMAN OTC DRUG Silky Finish Fluid OCTINOXATE LOTION TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 2.25 mL/30mL E 20171231 42248-129_0ef55387-f92b-4e32-9f13-faab49ddcb2c 42248-129 HUMAN OTC DRUG Whitening Glycobest OCTINOXATE avobenzone titanium oxide CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; AVOBENZONE; TITANIUM DIOXIDE 3.5; 1.5; 12.5 mL/50mL; mL/50mL; mL/50mL E 20171231 42248-130_84f78d03-09df-4ca4-ab2e-e7bac2e6551e 42248-130 HUMAN OTC DRUG PRO LASER BODY OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE 11.25; 37.5; 9 mL/150mL; mL/150mL; mL/150mL E 20171231 42248-131_7368590d-b54c-43d0-a4dc-627c20467892 42248-131 HUMAN OTC DRUG PERFECT BUST BODY OCTINOXATE CREAM TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 11.25 mL/150mL E 20171231 42248-132_a70fbcf1-c3e5-4653-a3c7-a3e29a190ac0 42248-132 HUMAN OTC DRUG FIRMING AND MOISTURIZING BODY OCTINOXATE EMULSION TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE 18.75 mL/250mL E 20171231 42248-133_b9f2c52e-0ab5-4cf7-8c36-8999ee352beb 42248-133 HUMAN OTC DRUG La Creme P OCTINOXATE AVOBENZONE TITANIUM DIOXIDE CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Zenith Medicosm SL OCTINOXATE; AVOBENZONE; TITANIUM DIOXIDE 3.75; 1.5; 12.5 mL/50mL; mL/50mL; mL/50mL E 20171231 42254-001_644ddc43-b2fa-44bd-aeb7-2547defb85e0 42254-001 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 19991027 NDA NDA021087 Rebel Distributors Corp OSELTAMIVIR PHOSPHATE 75 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] E 20171231 42254-002_a7c456e6-403b-4aae-a576-60b106bf66a7 42254-002 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110209 ANDA ANDA077154 Rebel Distributors Corp. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 42254-003_a3dc310a-3d75-4e1e-9f9f-ed5c77ff7bfe 42254-003 HUMAN PRESCRIPTION DRUG BACITRACIN BACITRACIN OINTMENT OPHTHALMIC 20100111 ANDA ANDA061212 Rebel Distributors Corp BACITRACIN 500 [iU]/g Decreased Cell Wall Synthesis & Repair [PE] E 20171231 42254-004_12d06309-0483-48c6-a9f2-b25dcc31db72 42254-004 HUMAN PRESCRIPTION DRUG Proventil HFA Albuterol Sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20011001 NDA NDA020503 Rebel Distributors Corp. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 42254-005_34f4cc6f-3751-470a-95c1-69ea911e24f5 42254-005 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Rebel Distributors Corp. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 42254-006_72287bb4-3f70-4e12-aaf3-cfff48e044f8 42254-006 HUMAN PRESCRIPTION DRUG Betadine povidone-iodine SOLUTION OPHTHALMIC 20000401 NDA NDA018634 Rebel Distributors Corp POVIDONE-IODINE 5 mg/mL E 20171231 42254-008_74238d87-5f82-4a5e-a920-a9fc68115e91 42254-008 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20100707 ANDA ANDA040350 Rebel Distributors Corp. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] E 20171231 42254-009_74238d87-5f82-4a5e-a920-a9fc68115e91 42254-009 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20100707 ANDA ANDA040350 Rebel Distributors Corp. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] E 20171231 42254-010_ff603c99-6620-4945-acdc-c9150b6f77d4 42254-010 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 19710723 ANDA ANDA080154 Rebel Distributors Corp. PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] E 20171231 42254-011_4743a48b-d4b5-4054-85e1-9d64cc40de25 42254-011 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20080801 ANDA ANDA078510 Rebel Distributors Corp. EPLERENONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 42254-012_1ceb560b-1a62-408d-8e30-23113e8c9dd3 42254-012 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 Rebel Distributors Corp TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 42254-013_4d4131f8-79d0-40a4-87e8-667fd2db8d7a 42254-013 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19940429 ANDA ANDA040075 Rebel Distributors Corp CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL E 20171231 42254-014_10f918f7-4782-470e-a50e-35c7c66bfd79 42254-014 HUMAN PRESCRIPTION DRUG Nuvigil armodafinil TABLET ORAL 20090601 NDA NDA021875 Rebel Distributors Corp ARMODAFINIL 50 mg/1 CIV E 20171231 42254-015_4f4fc43f-bcd5-4f98-bafc-20db6207c603 42254-015 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 19901130 ANDA ANDA073193 Rebel Distributors Corp DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 42254-019_2a8de5aa-936a-493e-a0e3-813cbc969c6d 42254-019 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA AUTHORIZED GENERIC NDA020702 Rebel Distributors Corp ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-022_1f8c4794-52cf-46d5-b0e5-3e758941d606 42254-022 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20110726 ANDA ANDA088628 Rebel Distributors Corp ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII E 20171231 42254-023_043665e5-c6e0-4353-9933-6ba9e4860842 42254-023 HUMAN PRESCRIPTION DRUG FLURBIPROFEN SODIUM flurbiprofen sodium SOLUTION/ DROPS OPHTHALMIC 19970529 NDA AUTHORIZED GENERIC NDA019404 Rebel Distributors Corp FLURBIPROFEN SODIUM .3 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-025_d3620ebe-87e1-4a93-96cc-ff20ddbb30b2 42254-025 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Rebel Distributors Corp LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-028_d3620ebe-87e1-4a93-96cc-ff20ddbb30b2 42254-028 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Rebel Distributors Corp LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-029_c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5 42254-029 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072235 Rebel Distributors Corp BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 42254-030_706f3bb5-1ada-420a-9d8e-79aea018df53 42254-030 HUMAN OTC DRUG clotrimazole Clotrimazole CREAM TOPICAL 20110603 OTC MONOGRAPH FINAL part333C Rebel Distributors Corp CLOTRIMAZOLE 1 g/100g E 20171231 42254-031_fea57e0a-c472-4c83-9afd-6765a16600b9 42254-031 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20110620 OTC MONOGRAPH FINAL part333B Rebel Distributors Corp BACITRACIN 500 [USP'U]/g E 20171231 42254-032_330e35ed-fd6b-4123-864a-a5aa339c24d6 42254-032 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Rebel Distributors Corp SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-033_fce0f66c-da3b-4037-ba0a-e89b1e301c16 42254-033 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 Rebel Distributors Corp ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 42254-034_940f3140-fe00-4297-ba81-f49bc3a3ace0 42254-034 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Rebel Distributors Corp IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-035_0defd325-d763-481e-afe8-86075e3c7e79 42254-035 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20100301 ANDA ANDA090200 Rebel Distributors Corp METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 42254-036_1b291d0a-1350-4637-bab3-f0bf43ab2a13 42254-036 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Rebel Distributors Corp DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-037_51f3222f-bc05-4117-881d-85880b092e42 42254-037 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20110118 ANDA ANDA073517 Rebel Distributors Corp KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-038_0defd325-d763-481e-afe8-86075e3c7e79 42254-038 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20100301 ANDA ANDA090200 Rebel Distributors Corp METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 42254-039_d7131853-8850-45bd-9227-c4b1916dd28d 42254-039 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20080420 ANDA ANDA065390 Rebel Distributors Corp RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 42254-040_b28a2d3c-69ca-4c97-915b-41135b9b5bc0 42254-040 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 Rebel Distributors Corp METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 42254-041_95990ec1-9cfd-4b94-afbd-7ced6ecca567 42254-041 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110301 ANDA ANDA075693 Rebel Distributors Corp IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 42254-043_fac73e19-3809-4846-8abc-f42a47c224ae 42254-043 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20071022 ANDA ANDA075576 Rebel Distributors Corp OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 42254-045_749af379-2de0-4644-ae06-e8b03d863582 42254-045 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 42254-046_200e9378-f0be-4d8c-a243-9283cd4f1977 42254-046 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Rebel Distributors Corp ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 42254-048_fce0f66c-da3b-4037-ba0a-e89b1e301c16 42254-048 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 Rebel Distributors Corp ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 42254-049_1bc85f95-c26a-4037-a02a-2248f6518fe2 42254-049 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Rebel Distributors Corp GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42254-050_a4e1d3bc-4e97-4ff0-9e30-22a699c96072 42254-050 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 42254-051_6ddf4f5b-b6bb-4a15-a621-cd327d27ec53 42254-051 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Rebel Distributors Corp TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 42254-052_7e2f72a2-a76f-46a0-9a0b-4414633bb864 42254-052 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20100430 ANDA ANDA075009 Rebel Distributors Corp ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-053_fac73e19-3809-4846-8abc-f42a47c224ae 42254-053 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20071022 ANDA ANDA075576 Rebel Distributors Corp OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 42254-054_f8c7c414-fcd2-47dd-8226-8d0c35d3e9f0 42254-054 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110209 ANDA ANDA077662 Rebel Distributors Corp GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42254-055_9cbdc7a7-2e87-4ba0-b5e5-70e15caae63d 42254-055 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100816 ANDA ANDA040702 Rebel Distributors Corp HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 42254-056_eb02779c-acdc-48ed-9d23-ca39ba152d0d 42254-056 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110901 ANDA ANDA078526 Rebel Distributors Corp LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42254-057_5cc4daa2-f108-4672-9dd8-06c3785bed28 42254-057 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 Rebel Distributors Corp DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 42254-059_05a94f49-3f12-462c-9180-ae75719d3441 42254-059 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20120410 ANDA ANDA075185 Rebel Distributors Corp DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-060_330e35ed-fd6b-4123-864a-a5aa339c24d6 42254-060 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Rebel Distributors Corp SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-061_c4ca2b1a-fdb8-4131-8b80-8784e79c1ce5 42254-061 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072234 Rebel Distributors Corp BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 42254-062_53b33c73-a220-4add-ba61-b00e9e9f852b 42254-062 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20100105 ANDA ANDA074118 Rebel Distributors Corp PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-063_940f3140-fe00-4297-ba81-f49bc3a3ace0 42254-063 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Rebel Distributors Corp IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-064_e5b36fbf-4db1-43b3-bf04-39022f74d0b9 42254-064 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Rebel Distributors Corp NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 42254-065_6efbbff4-db09-4d9d-93dd-6b6ce9271514 42254-065 HUMAN OTC DRUG Lice Treatment permethrin LOTION TOPICAL 20100328 ANDA ANDA075014 Rebel Distributors Corp PERMETHRIN 1 mg/100mL E 20171231 42254-066_17b2ac2b-f709-433b-961f-57a8dbe1c36a 42254-066 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Rebel Distributors Corp CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 42254-067_ceb0fc2d-9039-4961-84b6-ceb2a2649c50 42254-067 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 19950415 ANDA ANDA062512 Rebel Distributors Corp NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 42254-068_68723240-fed0-4ba7-bb7a-fac3de2398c9 42254-068 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 Rebel Distributors Corp CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 42254-069_ae578c2d-7ea2-4e18-bad8-c1da2429b7cb 42254-069 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20060713 ANDA ANDA077547 Rebel Distributors Corp METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 42254-070_407a8f85-11c4-4404-8678-1c5e68860c8f 42254-070 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20110919 ANDA ANDA073652 Rebel Distributors Corp NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 42254-071_8ca95053-18cb-468d-8e72-e02cf4d7c3bc 42254-071 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20110102 ANDA ANDA076345 Rebel Distributors Corp GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 42254-073_15f7cde7-8dc2-4b07-83a9-9b86d6ec7f43 42254-073 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090149 Rebel Distributors Corp AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 42254-074_15f7cde7-8dc2-4b07-83a9-9b86d6ec7f43 42254-074 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090149 Rebel Distributors Corp AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 42254-075_426f6918-7705-4988-a875-823196f43859 42254-075 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20110308 ANDA ANDA075536 Rebel Distributors Corp DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 42254-076_70cc0291-495b-4e2f-a431-ade9759ec4b7 42254-076 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 Rebel Distributors Corp CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 42254-077_6c450150-a7a4-46f3-b62a-848eeefada06 42254-077 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Rebel Distributors Corp ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 42254-078_ce85fa92-783e-4f71-b7ae-bc0eb0410e13 42254-078 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100113 ANDA ANDA040682 Rebel Distributors Corp BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 42254-079_7bbe8e4b-5210-400c-b89c-62c1822148bd 42254-079 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040356 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42254-080_4511cefb-084b-4191-899c-f500091f589c 42254-080 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Rebel Distributors Corp CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 42254-081_4f5f9977-2a78-4bf1-8e14-20dd24a119b4 42254-081 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Rebel Distributors Corp INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-086_2373655d-ac74-43f5-a041-9f41a5b92206 42254-086 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030601 ANDA ANDA076312 Rebel Distributors Corp MIRTAZAPINE 15 mg/1 E 20171231 42254-087_2373655d-ac74-43f5-a041-9f41a5b92206 42254-087 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030601 ANDA ANDA076312 Rebel Distributors Corp MIRTAZAPINE 30 mg/1 E 20171231 42254-088_b61aec30-66c0-4abe-a8ad-2d98d88f21b8 42254-088 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19960726 ANDA ANDA040069 Rebel Distributors Corp DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 42254-089_940f3140-fe00-4297-ba81-f49bc3a3ace0 42254-089 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Rebel Distributors Corp IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-090_58200048-a278-4f9a-b705-affc358537fb 42254-090 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Rebel Distributors Corp GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 42254-092_03a2a7f0-406c-4784-84c1-5fd5f5be4773 42254-092 HUMAN PRESCRIPTION DRUG Tamiflu Oseltamivir Phosphate POWDER, FOR SUSPENSION ORAL 20110711 NDA NDA021246 Rebel Distributors Corp OSELTAMIVIR PHOSPHATE 6 mg/mL Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] E 20171231 42254-093_565fcd92-6f4a-4060-be06-3001159264d9 42254-093 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 Rebel Distributors Corp NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 42254-094_0c6eed96-edfd-4e65-8eff-59d1ad51a59a 42254-094 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20110118 ANDA ANDA074229 Rebel Distributors Corp NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 42254-095_4bb9f3b7-2cc0-487d-9afa-027ddf7d7c16 42254-095 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Rebel Distributors Corp NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 42254-096_706af4a6-6595-48f9-be93-d57da75702c3 42254-096 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Rebel Distributors Corp LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 42254-097_6c450150-a7a4-46f3-b62a-848eeefada06 42254-097 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Rebel Distributors Corp ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 42254-100_7bbe8e4b-5210-400c-b89c-62c1822148bd 42254-100 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19881202 ANDA ANDA089971 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42254-102_de240524-7865-46a2-aa11-d06356ba9339 42254-102 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20091201 ANDA ANDA078345 Rebel Distributors Corp PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 42254-103_3345e995-7c5a-4e1c-949a-396ca7332023 42254-103 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Rebel Distributors Corp GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42254-104_7617f4a4-8812-44c4-8386-bc991f4d3a77 42254-104 HUMAN PRESCRIPTION DRUG ARMOUR THYROID THYROID TABLET ORAL 20101019 UNAPPROVED DRUG OTHER Rebel Distributors Corp THYROID 15 mg/1 E 20171231 42254-105_7617f4a4-8812-44c4-8386-bc991f4d3a77 42254-105 HUMAN PRESCRIPTION DRUG ARMOUR THYROID THYROID TABLET ORAL 20101019 UNAPPROVED DRUG OTHER Rebel Distributors Corp THYROID 30 mg/1 E 20171231 42254-106_d3620ebe-87e1-4a93-96cc-ff20ddbb30b2 42254-106 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Rebel Distributors Corp LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-107_87b3326b-7751-4aa5-b9c1-7e72a9daae1f 42254-107 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Rebel Distributors Corp ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 42254-108_3993eb55-f0e8-496c-a496-19dc509699e8 42254-108 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Rebel Distributors Corp CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 42254-109_f8c7c414-fcd2-47dd-8226-8d0c35d3e9f0 42254-109 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20110209 ANDA ANDA077662 Rebel Distributors Corp GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42254-110_03c66d8c-186a-4923-9a32-07ab07d472ad 42254-110 HUMAN PRESCRIPTION DRUG METHOTREXATE METHOTREXATE TABLET ORAL 19531207 NDA NDA008085 Rebel Distributors Corp METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 42254-111_706af4a6-6595-48f9-be93-d57da75702c3 42254-111 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Rebel Distributors Corp LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 42254-112_3345e995-7c5a-4e1c-949a-396ca7332023 42254-112 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Rebel Distributors Corp GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42254-113_706af4a6-6595-48f9-be93-d57da75702c3 42254-113 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Rebel Distributors Corp LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 42254-114_5b50291b-68c7-45a6-ae38-59f137ca7620 42254-114 HUMAN PRESCRIPTION DRUG Xodol hydrocodone bitartrate and acetaminophen TABLET ORAL 20111010 ANDA ANDA040556 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42254-115_a4e1d3bc-4e97-4ff0-9e30-22a699c96072 42254-115 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 42254-116_3993eb55-f0e8-496c-a496-19dc509699e8 42254-116 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Rebel Distributors Corp CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 42254-117_cf785971-902f-4423-866e-6edf44706679 42254-117 HUMAN OTC DRUG good sense ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990107 ANDA ANDA074937 Rebel Distributors Corp IBUPROFEN 100 mg/5mL E 20171231 42254-118_b03ca090-40fe-44b0-838a-69aed3424a06 42254-118 HUMAN PRESCRIPTION DRUG Silver Sulfadiazene Silver Sulfadiazine CREAM TOPICAL 19820225 NDA NDA018578 Rebel Distributors Corp SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 42254-119_3993eb55-f0e8-496c-a496-19dc509699e8 42254-119 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Rebel Distributors Corp CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 42254-121_9c244c88-dcc4-44fb-b0d9-13732dc705f5 42254-121 HUMAN PRESCRIPTION DRUG Etodolac etodolac CAPSULE ORAL 20100331 ANDA ANDA075078 Rebel Distributors Corp ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-122_637bf5a5-bc69-434d-a199-c2b89837002a 42254-122 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 Rebel Distributors Corp CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 42254-123_4a2530bc-176d-41c9-ab38-212165cbfa82 42254-123 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 Rebel Distributors Corp FEXOFENADINE HYDROCHLORIDE 60 mg/1 E 20171231 42254-124_18f7b809-b270-4d44-8065-685bac30efc0 42254-124 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20070910 ANDA ANDA077058 Rebel Distributors Corp PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 42254-125_4a58eea7-1956-4660-9899-600fd477f422 42254-125 HUMAN OTC DRUG Non-Habit Forming Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Rebel Distributors Corp DOCUSATE SODIUM 100 mg/1 E 20171231 42254-126_b971e151-4a68-4c01-8f9b-8c56f6bad18a 42254-126 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 Rebel Distributors Corp BUSPIRONE HYDROCHLORIDE 15 mg/1 E 20171231 42254-127_a4587ea9-c06b-4603-beea-1ef926a4d0be 42254-127 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 Rebel Distributors Corp CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 42254-129_330e35ed-fd6b-4123-864a-a5aa339c24d6 42254-129 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Rebel Distributors Corp SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-130_5fc5f29a-51e3-4f28-8b22-2ba9a7e64e7c 42254-130 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Rebel Distributors Corp ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 42254-131_44a07041-456a-4b0b-9a8a-9e1715327d33 42254-131 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Rebel Distributors Corp PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-132_f20e4b9d-2f50-412f-9710-223af851078b 42254-132 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 Rebel Distributors Corp HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 42254-133_ec3d8135-2892-4186-ac31-c7deadd0b975 42254-133 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20091022 ANDA ANDA075382 Rebel Distributors Corp ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 42254-134_aac6c6a4-17a3-4643-bc89-db7259aca03a 42254-134 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Rebel Distributors Corp PREGABALIN 225 mg/1 CV E 20171231 42254-136_20b3934b-edc4-40b8-b5fa-17259a200c5d 42254-136 HUMAN OTC DRUG hydrocortisone Hydrocortisone CREAM TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part348 Rebel Distributors Corp HYDROCORTISONE 1 g/100g E 20171231 42254-137_323bcad0-1e11-4946-a151-1a33557f0bfb 42254-137 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20110111 ANDA ANDA065085 Rebel Distributors Corp MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 42254-138_296e5977-0e8c-4147-a94d-374eb913ab51 42254-138 HUMAN OTC DRUG Cetirizine hydrochloride Cetirizine hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Rebel Distributors Corp CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 42254-139_7aef59fd-9baf-48eb-a16b-1b2ceafd3d84 42254-139 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 Rebel Distributors Corp AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 42254-140_a4fd8978-2036-43cb-ab16-b0dd98d6cd5b 42254-140 HUMAN PRESCRIPTION DRUG Prometh with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 19841031 ANDA ANDA088763 Rebel Distributors Corp PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV E 20171231 42254-141_a0f84fac-3f7c-45c0-a2e8-ce39fb2bd630 42254-141 HUMAN OTC DRUG Enteric Coated Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20110920 OTC MONOGRAPH FINAL part343 Rebel Distributors Corp ASPIRIN 325 mg/1 E 20171231 42254-142_250ac5c3-7cb0-4b93-a799-5aaa708144cd 42254-142 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 20060411 NDA NDA017010 Rebel Distributors Corp DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 42254-143_53b33c73-a220-4add-ba61-b00e9e9f852b 42254-143 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20100105 ANDA ANDA074116 Rebel Distributors Corp PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-144_a4e1d3bc-4e97-4ff0-9e30-22a699c96072 42254-144 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Rebel Distributors Corp VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 42254-145_89f9ffd5-358d-46db-9bff-66431597af64 42254-145 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20110726 ANDA ANDA088629 Rebel Distributors Corp ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 42254-146_42f92a36-4c11-44f6-8f82-716a8b7a3f08 42254-146 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080401 ANDA ANDA065392 Rebel Distributors Corp CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 42254-147_b9c6ed9c-c081-4a05-8f5e-bf646cfd5396 42254-147 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Rebel Distributors Corp ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 42254-149_0da14760-1131-4936-9a42-c40fc4db5cd0 42254-149 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir CREAM TOPICAL 20041029 NDA NDA021478 Rebel Distributors Corp ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 42254-150_0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b8 42254-150 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET ORAL 20110818 ANDA ANDA091211 Rebel Distributors Corp ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] E 20171231 42254-151_342ed5ed-2a53-4fc0-84f5-52b4094e1319 42254-151 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20060105 ANDA ANDA017522 Rebel Distributors Corp TRETINOIN .05 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 42254-152_1781fc07-5a2a-4b31-aad9-d0457eb704f4 42254-152 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Rebel Distributors Corp CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 42254-153_b6b530b3-5218-4838-adee-08e477757b98 42254-153 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20100607 ANDA ANDA074220 Rebel Distributors Corp CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 42254-154_c6c69fa4-d7be-4c09-b7fa-53c40fad78a7 42254-154 HUMAN PRESCRIPTION DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 20080425 ANDA ANDA064046 Rebel Distributors Corp BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 1/g; 1/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 42254-155_5c0dbae2-328b-42b6-a8b6-55009f3c78e5 42254-155 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20120216 OTC MONOGRAPH NOT FINAL part343 Rebel Distributors Corp ACETAMINOPHEN 80 mg/1 E 20171231 42254-158_1e9675c8-bcff-4621-90f7-b80489e1b840 42254-158 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Rebel Distributors Corp NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-159_d1f543fe-ebfb-4ace-a223-d928d6b648c1 42254-159 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Rebel Distributors Corp OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 42254-160_ec44482e-6194-4829-a3f7-ebe8d48a41a5 42254-160 HUMAN PRESCRIPTION DRUG EMEND aprepitant CAPSULE ORAL 20030326 NDA NDA021549 Rebel Distributors Corp APREPITANT 40 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] E 20171231 42254-161_d4f43676-0746-4765-9689-3f1e3075fa6a 42254-161 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA090568 Rebel Distributors Corp ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 42254-162_e843534e-47a2-46e3-92bb-d079467be606 42254-162 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Rebel Distributors Corp CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 42254-164_395df967-7532-4de5-a8b3-b34a4b3ace84 42254-164 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20060331 ANDA ANDA085025 Rebel Distributors Corp HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 42254-165_21cfe6a3-03b9-42f5-8f7f-111c56fe3c59 42254-165 HUMAN PRESCRIPTION DRUG Renova Tretinoin CREAM TOPICAL 20111018 NDA NDA021108 Rebel Distributors Corp TRETINOIN .2 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 42254-166_2a7d8bc7-45a3-497a-aa88-d3a3490aef11 42254-166 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 Rebel Distributors Corp FEXOFENADINE HYDROCHLORIDE 180 mg/1 E 20171231 42254-168_330e35ed-fd6b-4123-864a-a5aa339c24d6 42254-168 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Rebel Distributors Corp SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-169_6f63fe2d-fe55-473f-99cd-9c8eb97e562b 42254-169 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 42254-170_6f63fe2d-fe55-473f-99cd-9c8eb97e562b 42254-170 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] E 20171231 42254-171_6f63fe2d-fe55-473f-99cd-9c8eb97e562b 42254-171 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] E 20171231 42254-172_6f63fe2d-fe55-473f-99cd-9c8eb97e562b 42254-172 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Rebel Distributors Corp ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] E 20171231 42254-174_b6b530b3-5218-4838-adee-08e477757b98 42254-174 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20100607 ANDA ANDA074221 Rebel Distributors Corp CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 42254-175_79957ee5-5d59-45a9-8ff8-10cc75848d2a 42254-175 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20061018 ANDA ANDA077401 Rebel Distributors Corp MOMETASONE FUROATE 1 mg/g E 20171231 42254-176_3058bc96-c71d-41ed-97f2-ed68ad69a570 42254-176 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide OINTMENT TOPICAL 20091007 ANDA ANDA085691 Rebel Distributors Corp TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 42254-177_f910ec1a-3896-45b9-b8b2-df50a50064a1 42254-177 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20110114 ANDA ANDA065368 Rebel Distributors Corp CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 42254-178_3778db9b-ed94-4240-b045-d0d60f0ef9e9 42254-178 HUMAN OTC DRUG good neighbor pharmacy allergy diphenhydramine hydrochloride CAPSULE ORAL 19891015 OTC MONOGRAPH FINAL part341 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 42254-183_c22b0765-1777-4001-836a-2684daf2a35b 42254-183 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Rebel Distributors Corp SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 42254-185_d7c0dfda-2e49-4a9e-8fbb-cc40217ccc28 42254-185 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Rebel Distributors Corp BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 42254-187_26029ae3-d103-4ffd-b536-7366276f02bf 42254-187 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19931129 ANDA ANDA064052 Rebel Distributors Corp TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 42254-188_144e4973-d24a-4003-b5b1-d59fd835d884 42254-188 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Rebel Distributors Corp CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 42254-189_f493f828-9fdd-4723-9fc7-f691d3879696 42254-189 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Rebel Distributors Corp ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 42254-190_8dc7ea67-af85-4187-bf5a-b30878cc3f19 42254-190 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19721127 ANDA ANDA080817 Rebel Distributors Corp DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 42254-191_52802c0d-a617-4ba9-8f98-5a652025306c 42254-191 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Rebel Distributors Corp CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 42254-194_98a219ab-aa30-46cb-ac13-5c9095a75b40 42254-194 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110127 ANDA ANDA075661 Rebel Distributors Corp IBUPROFEN 200 mg/1 E 20171231 42254-195_8debb03e-a237-4e0d-be06-8ae17eaa14fa 42254-195 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20030925 ANDA ANDA076290 Rebel Distributors Corp LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 42254-196_9af821c9-8182-469a-9ba9-430903d50bfb 42254-196 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA072750 Rebel Distributors Corp METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 42254-197_87f388c6-c942-47f5-b685-0f7ce0e431f4 42254-197 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Rebel Distributors Corp CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 42254-198_ec3d8135-2892-4186-ac31-c7deadd0b975 42254-198 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20091022 ANDA ANDA075382 Rebel Distributors Corp ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 42254-202_3ff75342-03b6-462f-b6db-80bc1a52fe6c 42254-202 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Rebel Distributors Corp PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-203_d6a92eba-0841-474b-96f3-778f060ab133 42254-203 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Rebel Distributors Corp OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 42254-204_d6a92eba-0841-474b-96f3-778f060ab133 42254-204 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Rebel Distributors Corp OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 42254-205_d6a92eba-0841-474b-96f3-778f060ab133 42254-205 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Rebel Distributors Corp OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 42254-206_d976599a-0ee0-4fa4-afe6-bdfbca570afe 42254-206 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076133 Rebel Distributors Corp OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 42254-212_c286dba1-e6b1-4cf0-936d-9af42d8eedc3 42254-212 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Rebel Distributors Corp ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 42254-213_a9fdc04a-b4e5-4eed-be1f-8a629dc447be 42254-213 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Rebel Distributors Corp ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 42254-214_5f215257-7c82-478f-a263-6fb37b438d69 42254-214 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42254-216_b5e516a0-d0f4-4613-ab56-b1bb440fcb78 42254-216 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 Rebel Distributors Corp ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 42254-218_ac3aa150-2083-4fb0-9663-e92c1dc3135a 42254-218 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20110118 ANDA ANDA074229 Rebel Distributors Corp NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 42254-220_b56f236d-fbf8-48e3-ad42-8abe4aafcbfc 42254-220 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, COATED ORAL 20090810 ANDA ANDA076933 Rebel Distributors Corp SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 42254-221_87a90438-84b6-4485-b43a-d9b9a58b933a 42254-221 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Rebel Distributors Corp NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-222_268c5d9e-a9ce-4ab5-8d7c-902c8be38c59 42254-222 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Rebel Distributors Corp OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 42254-223_16796dd0-8d42-4e0e-8a9f-2b3b8834ed84 42254-223 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040084 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 750 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42254-227_a9465919-2a5f-40f9-a8e4-ce75f7a651d4 42254-227 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 ANDA ANDA077255 Rebel Distributors Corp LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 42254-228_16796dd0-8d42-4e0e-8a9f-2b3b8834ed84 42254-228 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040201 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42254-229_ed49fb2a-05f6-4df5-9c75-30df41a5aae1 42254-229 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20091030 ANDA ANDA065123 Rebel Distributors Corp MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 42254-230_c863fdd7-5919-4ee0-b2d1-952c5faf3a09 42254-230 HUMAN OTC DRUG all day pain relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Rebel Distributors Corp NAPROXEN SODIUM 220 mg/1 E 20171231 42254-235_7e82dcaa-fc75-4ea2-9465-5327e2747720 42254-235 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Rebel Distributors Corp FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 42254-237_4b8dbfb7-5f20-4398-937a-72ed536c57c4 42254-237 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 ANDA ANDA018851 Rebel Distributors Corp INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-239_92f5c528-e1af-4268-9f5f-ae5558a5104c 42254-239 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 Rebel Distributors Corp CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 42254-242_eaf4191c-5b2f-47bd-b315-f695f8773260 42254-242 HUMAN PRESCRIPTION DRUG Junel Fe 1.5/30 norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20110121 ANDA ANDA076064 Rebel Distributors Corp E 20171231 42254-243_0193faa4-9b02-4ccd-9751-de6124cc8c68 42254-243 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20110603 ANDA ANDA090289 Rebel Distributors Corp LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 42254-244_16796dd0-8d42-4e0e-8a9f-2b3b8834ed84 42254-244 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040084 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 650 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42254-248_2b810942-e143-4e4f-8820-00af4f2e0c1e 42254-248 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20080114 NDA NDA021234 Rebel Distributors Corp DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42254-250_4ff074d6-3aa3-47cd-9667-cace82ba5185 42254-250 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate CREAM TOPICAL 20070716 ANDA ANDA078162 Rebel Distributors Corp HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 42254-254_b4a84767-975f-46ae-a734-efa3ee3394fb 42254-254 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Rebel Distributors Corp LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 42254-257_a522f324-70a0-4051-830b-57a658c1e065 42254-257 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20080317 ANDA ANDA076128 Rebel Distributors Corp OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 42254-260_684602ed-06c6-4633-b587-135c616f091e 42254-260 HUMAN PRESCRIPTION DRUG Levora Levonorgestrel and Ethinyl Estradiol KIT 20020410 ANDA ANDA073594 Rebel Distributors Corp E 20171231 42254-261_f394be03-fefc-4679-b001-4168a204a136 42254-261 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA AUTHORIZED GENERIC NDA020702 Rebel Distributors Corp ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-263_a4f92eb4-0df1-4300-aebd-6082fe804ac8 42254-263 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA201522 Rebel Distributors Corp MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 42254-266_6e5b23dd-0173-48a9-875d-def97662b060 42254-266 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 Rebel Distributors Corp METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 42254-267_df64ffb8-f40f-479f-8c7b-a4b2011664e8 42254-267 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA AUTHORIZED GENERIC NDA020702 Rebel Distributors Corp ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-268_1cc18146-d9be-4975-89ba-e99a85f71c76 42254-268 HUMAN PRESCRIPTION DRUG Donnatal Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide TABLET ORAL 20080507 UNAPPROVED DRUG OTHER Rebel Distributors Corp PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 42254-269_2e99000d-aec8-497a-ab2c-cd58937086c1 42254-269 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Rebel Distributors Corp MIRTAZAPINE 45 mg/1 E 20171231 42254-277_4aad770b-a342-45c5-8199-21a124060314 42254-277 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110901 ANDA ANDA090484 Rebel Distributors Corp LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42254-281_aadcb1a8-2605-40b3-a652-2787ec833278 42254-281 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19990512 ANDA ANDA074686 Rebel Distributors Corp GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 42254-282_f0c660da-4198-4d04-87e9-5d6a7b6f75cf 42254-282 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 Rebel Distributors Corp AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 42254-284_da4cd3fc-906d-4468-b7f9-c20f085c95ed 42254-284 HUMAN PRESCRIPTION DRUG Nystatin nystatin OINTMENT TOPICAL 19820923 ANDA ANDA062124 Rebel Distributors Corp NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 42254-287_7a62dd77-bc33-4f4e-9cbf-980e3ec80ff7 42254-287 HUMAN PRESCRIPTION DRUG Necon 0.5/35 Norethindrone and Ethinyl Estradiol Tablets KIT 19870129 ANDA ANDA070686 Rebel Distributors Corp E 20171231 42254-288_4b8c6afe-2d76-46c7-a23e-99db5e180ff6 42254-288 HUMAN PRESCRIPTION DRUG LASTACAFT alcaftadine SOLUTION/ DROPS OPHTHALMIC 20101101 NDA NDA022134 Rebel Distributors Corp ALCAFTADINE 2.5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 42254-291_7e233783-c467-4ca7-8849-7e1526bb2de0 42254-291 HUMAN PRESCRIPTION DRUG Xodol hydrocodone bitartrate and acetaminophen TABLET ORAL 20111010 ANDA ANDA040658 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42254-295_0e4c7ff6-7bea-4257-bd95-d4d5298ae426 42254-295 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate SUPPOSITORY VAGINAL 19970430 ANDA ANDA074414 Rebel Distributors Corp MICONAZOLE NITRATE 100 ug/1 E 20171231 42254-300_a05c255c-6e0b-4e86-b907-738b777fc524 42254-300 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120517 ANDA ANDA040846 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42254-301_7e233783-c467-4ca7-8849-7e1526bb2de0 42254-301 HUMAN PRESCRIPTION DRUG Xodol hydrocodone bitartrate and acetaminophen TABLET ORAL 20111010 ANDA ANDA040556 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42254-302_23764466-adbe-4c9c-be60-3b09458d634e 42254-302 HUMAN PRESCRIPTION DRUG NEO-POLYCIN NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT OPHTHALMIC 20110715 ANDA ANDA060764 Rebel Distributors Corp NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; U/g; U/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] E 20171231 42254-303_1211504c-f89b-42ed-9d7a-2e1a658a9ccf 42254-303 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20090915 ANDA ANDA065203 Rebel Distributors Corp NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 42254-305_09b48fda-460a-496b-8644-db205465d06c 42254-305 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110528 ANDA ANDA091267 Rebel Distributors Corp DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 42254-306_f1153794-33ae-4e9d-8c80-d29e01f82d77 42254-306 HUMAN PRESCRIPTION DRUG Griseofulviin (microsize) Griseofulvin (microsize) SUSPENSION ORAL 20070726 ANDA ANDA065394 Rebel Distributors Corp GRISEOFULVIN 125 mg/5mL Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] E 20171231 42254-307_2b5f69aa-2dd9-4eb8-b8b8-def1a1ec1433 42254-307 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Rebel Distributors Corp ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 42254-310_41a781b4-da67-4650-a99b-593fc34465da 42254-310 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Rebel Distributors Corp LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42254-315_c9d22362-e442-4690-9aa9-9d34aef09504 42254-315 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 20040101 ANDA ANDA075010 Rebel Distributors Corp IBUPROFEN 200 mg/1 E 20171231 42254-319_74a80da6-0279-4946-b7ee-d3e43330ba2c 42254-319 HUMAN OTC DRUG Miconazole Nitrate miconazole nitrate CREAM TOPICAL 20030901 OTC MONOGRAPH FINAL part333C Rebel Distributors Corp MICONAZOLE NITRATE 20 mg/g E 20171231 42254-322_8ce02e76-303c-4e06-a47e-0a7bbf46c3f2 42254-322 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20120127 ANDA ANDA064042 Rebel Distributors Corp NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 42254-323_4b874a3d-db5a-40dc-a69c-d67c76b82b49 42254-323 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030825 ANDA ANDA040513 Rebel Distributors Corp BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 500; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 42254-331_152fb727-d516-441e-a72b-33ddf1a325c1 42254-331 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 Rebel Distributors Corp LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 42254-335_851ff660-e6a4-48f8-a6d0-4c10dbb01836 42254-335 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Rebel Distributors Corp CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 42254-338_a00e07e9-2c16-4d3e-bb63-6fd2b05fe1b7 42254-338 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20071207 ANDA ANDA065326 Rebel Distributors Corp CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 42254-340_a46da71a-5fe1-4021-b866-4a806a12efa8 42254-340 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42254-346_4b8f1462-d3f0-40f1-9f4a-7e54171fb8b8 42254-346 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20070223 ANDA ANDA040813 Rebel Distributors Corp HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42254-351_fa1c61c2-7e24-40ff-916e-456b8725a5cd 42254-351 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20090223 ANDA ANDA070098 Rebel Distributors Corp METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 42254-353_851ff660-e6a4-48f8-a6d0-4c10dbb01836 42254-353 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Rebel Distributors Corp CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 42254-355_09ab5bc2-645f-415d-ad76-246385690176 42254-355 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY, METERED NASAL 20030331 ANDA ANDA076103 Rebel Distributors Corp IPRATROPIUM BROMIDE 42 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 42254-359_83ae6177-afbb-477f-a5ff-64d48960ffef 42254-359 HUMAN OTC DRUG nasal decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19990812 ANDA ANDA075153 Rebel Distributors Corp PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 E 20171231 42254-362_87d891bc-9286-4b87-a166-fccdf37fd520 42254-362 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Rebel Distributors Corp ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 42254-426_87fce959-ba71-46b8-911d-2004658196ce 42254-426 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19841107 ANDA ANDA062396 Rebel Distributors Corp DOXYCYCLINE HYCLATE 50 mg/1 E 20171231 42255-586_624072ff-e10e-d357-e053-2991aa0ad313 42255-586 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20121227 OTC MONOGRAPH NOT FINAL part333A ZHEJIANG GREENFACE HOUSEWARES CO., LTD. BENZALKONIUM CHLORIDE .115 g/100g N 20191231 42255-587_624072ff-e104-d357-e053-2991aa0ad313 42255-587 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130117 OTC MONOGRAPH NOT FINAL part333A ZHEJIANG GREENFACE HOUSEWARES CO., LTD. BENZALKONIUM CHLORIDE .1 g/100g N 20191231 42255-603_623ffcc6-81a7-b41e-e053-2991aa0a4cdf 42255-603 HUMAN OTC DRUG Acne wipes salicylic acid SWAB TOPICAL 20150506 OTC MONOGRAPH FINAL part333D ZHEJIANG GREENFACE HOUSEWARES CO., LTD. SALICYLIC ACID .5 g/100g N 20191231 42255-800_6240dcff-6a98-0ffa-e053-2991aa0abbfc 42255-800 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130314 OTC MONOGRAPH NOT FINAL part333A ZHEJIANG GREENFACE HOUSEWARES CO., LTD. BENZALKONIUM CHLORIDE .1 g/100g N 20191231 42255-900_624072ff-e098-d357-e053-2991aa0ad313 42255-900 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130314 OTC MONOGRAPH NOT FINAL part333A ZHEJIANG GREENFACE HOUSEWARES CO., LTD. BENZALKONIUM CHLORIDE .115 g/100g N 20191231 42263-101_ff916fda-5163-48a5-92df-f4a049cc94a1 42263-101 HUMAN OTC DRUG BABY SUNSCREEN SPF 30 ZINC OXIDE LOTION TOPICAL 20111230 OTC MONOGRAPH FINAL part352 SEVENTH GENERATION INC ZINC OXIDE 20 g/100g E 20171231 42265-101_264fab26-2c13-422e-9395-23029b2d0b82 42265-101 HUMAN OTC DRUG Unblem Est Benzoyl Peroxide CREAM TOPICAL 20121025 OTC MONOGRAPH FINAL part333D Elli Est BENZOYL PEROXIDE 100 mg/g E 20171231 42268-1001_95cfd87f-b59a-46fb-ad6b-4fad3a80a2ff 42268-1001 HUMAN OTC DRUG TS (Talmostop) niacinamide SHAMPOO TOPICAL 20120201 UNAPPROVED DRUG OTHER Talmocom Co., Ltd NIACINAMIDE .3 mL/100mL N 20181231 42268-2001_c1519f8c-d48b-4bbe-9df6-827f6cdd12ac 42268-2001 HUMAN OTC DRUG TS (Talmostop) Hair Tonic niacinamide LIQUID TOPICAL 20120201 UNAPPROVED DRUG OTHER Talmocom Co., Ltd NIACINAMIDE .3 mL/100mL N 20181231 42268-3001_4bb403f0-6862-467b-b611-fe881a1c5142 42268-3001 HUMAN OTC DRUG TS (Talmostop) Talhwan niacinamide PELLET TOPICAL 20120201 UNAPPROVED DRUG OTHER Talmocom Co., Ltd NIACINAMIDE .3 g/100g N 20181231 42268-4001_f28fb06b-5023-4776-912a-c26f989f93ca 42268-4001 HUMAN OTC DRUG PREMIUM TS Talmostop NIACINAMIDE SHAMPOO TOPICAL 20141104 UNAPPROVED DRUG OTHER Talmocom Co., Ltd NIACINAMIDE; PANTHENOL .3; .5 g/100mL; g/100mL N 20181231 42268-5001_16a573a0-41d4-40b5-b600-6526021475ca 42268-5001 HUMAN OTC DRUG PREMIUM TS Talmostop Rich NIACINAMIDE SHAMPOO TOPICAL 20141104 UNAPPROVED DRUG OTHER Talmocom Co., Ltd NIACINAMIDE; PANTHENOL .3; .5 g/100mL; g/100mL N 20181231 42268-6001_36c6cc72-968c-1cc3-e054-00144ff88e88 42268-6001 HUMAN OTC DRUG All New TS NIACINAMIDE SHAMPOO TOPICAL 20160701 UNAPPROVED DRUG OTHER Talmocom Co., Ltd NIACINAMIDE; PANTHENOL .3; .5 g/100mL; g/100mL N 20181231 42268-7001_36c837fa-c2e9-53bc-e054-00144ff88e88 42268-7001 HUMAN OTC DRUG Premium TS NIACINAMIDE SHAMPOO TOPICAL 20160704 UNAPPROVED DRUG OTHER Talmocom Co., Ltd NIACINAMIDE; PANTHENOL .3; .5 g/100mL; g/100mL N 20181231 42271-100_56bd854e-d50f-140a-e054-00144ff8d46c 42271-100 HUMAN OTC DRUG MediGummies Cold and Sinus Chlorpheniramine Maleate and Phenylephrine Hydrochloride CHEWABLE GEL ORAL 20171231 OTC MONOGRAPH FINAL part341 Harmony Foods D/B/A Santa Cruz Pharmaceuticals CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 42271-200_56bdd1ae-031f-3c59-e054-00144ff88e88 42271-200 HUMAN OTC DRUG MediGummies Allergy and Sinus Chlorpheniramine Maleate and Phenylephrine Hydrochloride CHEWABLE GEL ORAL 20171231 OTC MONOGRAPH FINAL part341 Harmony Foods D/B/A Santa Cruz Pharmaceuticals CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 42281-001_22afdb6f-8688-4eb6-b720-e7c8dc4ad56a 42281-001 HUMAN OTC DRUG Belli Acne Control Spot Treatment SULFUR CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part333D ABT Belli-Materna Inc SULFUR 30 mg/mL N 20181231 42281-003_6a47bdbd-d9e9-4905-8f5d-10e41e6e32d8 42281-003 HUMAN OTC DRUG Belli Pure Radiance Facial Sunscreen Tinted Protection SPF 25 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 ABT Belli-Materna Inc TITANIUM DIOXIDE; ZINC OXIDE 70; 50 mg/mL; mg/mL N 20181231 42283-001_271f3a99-9479-6db3-e054-00144ff8d46c 42283-001 HUMAN OTC DRUG Lactovit Mens Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20111227 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE 15 mg/100mL E 20171231 42283-002_4a1137ea-ee43-4c18-836b-8ae00df2a002 42283-002 HUMAN OTC DRUG Lactovit Original Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20111227 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE 15 mL/100mL E 20171231 42283-003_271f3481-a831-5fa8-e054-00144ff8d46c 42283-003 HUMAN OTC DRUG Lactovit Sensitive Skin Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20111227 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE 10 mg/100mL E 20171231 42283-004_6eb416d7-5163-424b-a95e-f496e2ad10b1 42283-004 HUMAN OTC DRUG AVENA kinesia ROLL-ON DEODORANT/ANTIPERSPIRANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20131205 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE 100 mg/mL E 20171231 42283-005_a3a36894-e1b3-4ccd-8a39-0202eadd4517 42283-005 HUMAN OTC DRUG AVENA kinesia ROLL-ON DEODORANT/ANTIPERSPIRANT with Oat and Aloe Vera ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20131205 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE 100 mg/mL E 20171231 42283-006_271f36fb-8ce4-49a1-e054-00144ff88e88 42283-006 HUMAN OTC DRUG Lactovit Lactourea ROLL-ON DEODORANT ANTIPERSPIRANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20140220 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE 100 mg/mL E 20171231 42283-007_271f425b-138f-4afd-e054-00144ff88e88 42283-007 HUMAN OTC DRUG Lactovit INVISIBLE ANTISTAIN DEODORANT AND ANTIPERSPIRANT ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY LIQUID TOPICAL 20150415 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 110 mg/mL E 20171231 42283-020_41c73a50-e0ad-5c97-e054-00144ff8d46c 42283-020 HUMAN OTC DRUG Lactovit DEODORANT AND ANTIPERSPIRANT INVISIBLE ANTISTAIN ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20161119 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM SESQUICHLOROHYDRATE; ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 1; 8 mg/1; mg/1 E 20171231 42283-021_41b2ad64-4ef2-3080-e054-00144ff8d46c 42283-021 HUMAN OTC DRUG Lactovit DEO ROLL-ON LACTOUREA DEODORANT ANTIPERSPIRANT ALUMINUM CHLOROHYDRATE, ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20161119 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE; ALUMINUM SESQUICHLOROHYDRATE 6.4; .6464 mg/mL; mg/mL E 20171231 42283-022_41ebd4b7-f9cb-5a11-e054-00144ff8d46c 42283-022 HUMAN OTC DRUG Lactovit Mens Roll On Antiperspirant Deodorant Aluminum Chlorohydrate, ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20161119 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE; ALUMINUM SESQUICHLOROHYDRATE 9.6; .9696 mg/1; mg/1 E 20171231 42283-023_41fbf8e8-2937-3d14-e054-00144ff8d46c 42283-023 HUMAN OTC DRUG Lactovit DEO ROLL ON LACTOUREA DEODORANT ANTIPERSPIRANT ALUMINUM CHLOROHYDRATE, ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20161119 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE; ALUMINUM SESQUICHLOROHYDRATE 6.4; .808 mg/1; mg/1 E 20171231 42283-024_42028ae9-4bed-278f-e054-00144ff8d46c 42283-024 HUMAN OTC DRUG Lactovit Original Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate, Aluminium sesquichlorohydrate LIQUID TOPICAL 20161123 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM CHLOROHYDRATE; ALUMINUM SESQUICHLOROHYDRATE 11.2; 1.1312 mg/1; mg/1 E 20171231 42283-025_4c7d241e-446b-0933-e054-00144ff88e88 42283-025 HUMAN OTC DRUG Lactovit DEODORANT ROLL-ON MEN INVISIBLE Aluminum Zirconium Octachlorohydrex Gly, Aluminum Sesquichlorohydrate LIQUID TOPICAL 20170406 OTC MONOGRAPH FINAL part350 Laboratorios Genesse SL ALUMINUM SESQUICHLOROHYDRATE; ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .8; 5.28 mg/1; mg/1 N 20181231 42283-026_63f2ba91-40b9-47f8-e053-2991aa0acb77 42283-026 HUMAN OTC DRUG LACTOVIT INVISIBLE ANTISTAIN DEODORANT AND ANTIPERSPIRANT ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY CREAM TOPICAL 20180123 OTC MONOGRAPH FINAL part350 AC Marca Personal Care ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 99 mg/mL N 20191231 42283-027_63f2bf2c-d1d2-4941-e053-2a91aa0a26b7 42283-027 HUMAN OTC DRUG LACTOVIT MEN DEODORANT AND ANTIPERSPIRANT ALUMINUM CHLOROHYDRATE CREAM TOPICAL 20180123 OTC MONOGRAPH FINAL part350 AC Marca Personal Care ALUMINUM CHLOROHYDRATE 120 mg/mL N 20191231 42283-028_63f2bf2c-d1e8-4941-e053-2a91aa0a26b7 42283-028 HUMAN OTC DRUG LACTOVIT ORIGINAL DEODORANT AND ANTIPERSPIRANT ALUMINUM CHLOROHYDRATE CREAM TOPICAL 20180123 OTC MONOGRAPH FINAL part350 AC Marca Personal Care ALUMINUM CHLOROHYDRATE 140 mg/mL N 20191231 42283-029_63f2c25d-9b30-e8e6-e053-2991aa0a9077 42283-029 HUMAN OTC DRUG LACTOVIT MEN INVISIBLE ANTISTAIN DEODORANT AND ANTIPERSPIRANT ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY CREAM TOPICAL 20180123 OTC MONOGRAPH FINAL part350 AC Marca Personal Care ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 99 mg/mL N 20191231 42283-030_63f2c25d-9b2d-e8e6-e053-2991aa0a9077 42283-030 HUMAN OTC DRUG LACTOVIT SENSITIVE SKINS DEODORANT AND ANTIPERSPIRANT ALUMINUM CHLOROHYDRATE CREAM TOPICAL 20180123 OTC MONOGRAPH FINAL part350 AC Marca Personal Care ALUMINUM CHLOROHYDRATE 80 mg/mL N 20191231 42283-031_63f2bf2c-d1bf-4941-e053-2a91aa0a26b7 42283-031 HUMAN OTC DRUG LACTOVIT LACTOUREA DEODORANT AND ANTIPERSPIRANT ALUMINUM CHLOROHYDRATE CREAM TOPICAL 20180123 OTC MONOGRAPH FINAL part350 AC Marca Personal Care ALUMINUM CHLOROHYDRATE 63 mg/mL N 20191231 42288-000_d6ce07ce-edee-46ee-93d1-bb4411373b7f 42288-000 HUMAN OTC DRUG Spearmint and Peppermint PLAQUE A WAY Fluoride AnticavityGentle Formula Gentle Formula SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20121003 OTC MONOGRAPH FINAL part355 SLH Optimal Health LLC SODIUM FLUORIDE .24 g/100g E 20171231 42291-086_625b50b2-ea64-0df7-e053-2991aa0ab6fe 42291-086 HUMAN PRESCRIPTION DRUG ACITRETIN ACITRETIN CAPSULE ORAL 20171011 ANDA ANDA204633 AvKARE, Inc. ACITRETIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 42291-087_625b50b2-ea64-0df7-e053-2991aa0ab6fe 42291-087 HUMAN PRESCRIPTION DRUG ACITRETIN ACITRETIN CAPSULE ORAL 20171011 ANDA ANDA204633 AvKARE, Inc. ACITRETIN 17.5 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 42291-088_625b50b2-ea64-0df7-e053-2991aa0ab6fe 42291-088 HUMAN PRESCRIPTION DRUG ACITRETIN ACITRETIN CAPSULE ORAL 20171011 ANDA ANDA204633 AvKARE, Inc. ACITRETIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 42291-089_62981c07-8be5-5f9d-e053-2991aa0a6362 42291-089 HUMAN PRESCRIPTION DRUG acetazolamide acetazolamide TABLET ORAL 20170518 ANDA ANDA205530 AvKARE, Inc. ACETAZOLAMIDE 125 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20191231 42291-090_62981c07-8be5-5f9d-e053-2991aa0a6362 42291-090 HUMAN PRESCRIPTION DRUG acetazolamide acetazolamide TABLET ORAL 20170518 ANDA ANDA205530 AvKARE, Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20191231 42291-095_62984bb7-8822-4999-e053-2a91aa0a8f38 42291-095 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170412 ANDA ANDA205064 AvKARE, Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20191231 42291-096_62984bb7-8822-4999-e053-2a91aa0a8f38 42291-096 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170412 ANDA ANDA205064 AvKARE, Inc. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20191231 42291-097_62984bb7-8822-4999-e053-2a91aa0a8f38 42291-097 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170412 ANDA ANDA205064 AvKARE, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20191231 42291-098_62984bb7-8822-4999-e053-2a91aa0a8f38 42291-098 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170412 ANDA ANDA205064 AvKARE, Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20191231 42291-099_62984bb7-8822-4999-e053-2a91aa0a8f38 42291-099 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170412 ANDA ANDA205064 AvKARE, Inc. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20191231 42291-100_62984bb7-8822-4999-e053-2a91aa0a8f38 42291-100 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170412 ANDA ANDA205064 AvKARE, Inc. ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20191231 42291-101_62d429f8-df40-327d-e053-2991aa0a598f 42291-101 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091214 ANDA ANDA075047 AvKARE, Inc. ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 42291-102_62d429f8-df40-327d-e053-2991aa0a598f 42291-102 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091214 ANDA ANDA075047 AvKARE, Inc. ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 42291-103_626e9654-62aa-0ea0-e053-2991aa0a6a2e 42291-103 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE Acetazolamide TABLET ORAL 20120702 ANDA ANDA084840 AvKARE, Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20191231 42291-104_62d472c7-2e9a-d9f5-e053-2991aa0a6421 42291-104 HUMAN PRESCRIPTION DRUG Acamprosate Calcium Acamprosate Calcium TABLET, DELAYED RELEASE ORAL 20160516 ANDA ANDA200143 AvKARE, Inc. ACAMPROSATE CALCIUM 333 mg/1 N 20191231 42291-107_e1553f16-63e3-fccf-c7fe-9f8f621b1d42 42291-107 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20130708 ANDA ANDA075090 AvKARE, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 42291-108_1949ee18-df5d-4b07-8ea7-f51a7affdbea 42291-108 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 AvKARE, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 42291-109_1949ee18-df5d-4b07-8ea7-f51a7affdbea 42291-109 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 AvKARE, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 42291-110_fc723344-1e9f-ee85-ff75-20f2ec3e374a 42291-110 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride ER Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120313 ANDA ANDA079013 AvKARE, Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 42291-116_01ed3ebb-ea0f-416a-990e-2a81cb9e2257 42291-116 HUMAN PRESCRIPTION DRUG Aspirin and Extended-Release Dipyridamole Aspirin and Extended-Release Dipyridamole CAPSULE ORAL 20170427 ANDA ANDA206392 AvKARE, Inc. ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 42291-118_62d4fd56-7853-bcc5-e053-2a91aa0aca75 42291-118 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20170125 ANDA ANDA075424 AvKARE, Inc. AMIODARONE HYDROCHLORIDE 100 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 42291-122_62d4c259-7915-719c-e053-2a91aa0a35de 42291-122 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL 20120328 ANDA ANDA079133 AvKARE, Inc. AMILORIDE HYDROCHLORIDE 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20191231 42291-123_62d5574b-5c72-3594-e053-2a91aa0aaf08 42291-123 HUMAN PRESCRIPTION DRUG Alosetron Hydrochloride Alosetron Hydrochloride TABLET, FILM COATED ORAL 20170223 ANDA ANDA206647 AvKARE, Inc. ALOSETRON HYDROCHLORIDE .5 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 42291-124_62d5574b-5c72-3594-e053-2a91aa0aaf08 42291-124 HUMAN PRESCRIPTION DRUG Alosetron Hydrochloride Alosetron Hydrochloride TABLET, FILM COATED ORAL 20170223 ANDA ANDA206647 AvKARE, Inc. ALOSETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 42291-125_62d5da33-50dd-6137-e053-2991aa0a110a 42291-125 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130807 ANDA ANDA078720 AvKARE, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20191231 42291-130_62d7a264-770b-afab-e053-2a91aa0ad67f 42291-130 HUMAN PRESCRIPTION DRUG acarbose acarbose TABLET ORAL 20131224 ANDA ANDA091343 AvKARE, Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20191231 42291-131_62d7a264-770b-afab-e053-2a91aa0ad67f 42291-131 HUMAN PRESCRIPTION DRUG acarbose acarbose TABLET ORAL 20131224 ANDA ANDA091343 AvKARE, Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20191231 42291-132_62d7a264-770b-afab-e053-2a91aa0ad67f 42291-132 HUMAN PRESCRIPTION DRUG acarbose acarbose TABLET ORAL 20131224 ANDA ANDA091343 AvKARE, Inc. ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20191231 42291-139_62d4fd56-7853-bcc5-e053-2a91aa0aca75 42291-139 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20160318 ANDA ANDA076362 AvKARE, Inc. AMIODARONE HYDROCHLORIDE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 42291-140_62d7b3c5-cfaf-08d3-e053-2a91aa0abb8f 42291-140 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130617 ANDA ANDA074056 AvKARE, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 42291-141_62d7b3c5-cfaf-08d3-e053-2a91aa0abb8f 42291-141 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130617 ANDA ANDA074056 AvKARE, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 42291-142_62d7b3c5-cfaf-08d3-e053-2a91aa0abb8f 42291-142 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130617 ANDA ANDA074056 AvKARE, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 42291-143_090a2b62-2d72-7d03-069b-12bb45477099 42291-143 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130708 ANDA ANDA091624 AvKARE, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42291-144_090a2b62-2d72-7d03-069b-12bb45477099 42291-144 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130708 ANDA ANDA091624 AvKARE, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42291-145_090a2b62-2d72-7d03-069b-12bb45477099 42291-145 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130708 ANDA ANDA091624 AvKARE, Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42291-146_090a2b62-2d72-7d03-069b-12bb45477099 42291-146 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130708 ANDA ANDA091624 AvKARE, Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42291-153_62d7f61f-6e5c-244c-e053-2991aa0afca5 42291-153 HUMAN PRESCRIPTION DRUG AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE SPRAY, METERED NASAL 20160401 ANDA ANDA090176 AvKARE, Inc. AZELASTINE HYDROCHLORIDE 137 ug/.137mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 42291-157_62d7e2d4-a1ac-5faf-e053-2a91aa0a8e58 42291-157 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20160629 ANDA ANDA077883 AvKARE, Inc. BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20191231 42291-158_62d80793-ad78-70c3-e053-2a91aa0acc85 42291-158 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20140825 ANDA ANDA078220 AvKARE, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20191231 42291-159_62d80793-ad78-70c3-e053-2a91aa0acc85 42291-159 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20140825 ANDA ANDA077241 AvKARE, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20191231 42291-160_62d80793-ada6-70c3-e053-2a91aa0acc85 42291-160 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20090729 ANDA ANDA076820 AvKARE, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 42291-161_62d80793-ada6-70c3-e053-2a91aa0acc85 42291-161 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100729 ANDA ANDA076820 AvKARE, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 42291-162_62d80793-ada6-70c3-e053-2a91aa0acc85 42291-162 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20090729 ANDA ANDA076820 AvKARE, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 42291-163_62d80793-ada6-70c3-e053-2a91aa0acc85 42291-163 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20090729 ANDA ANDA076820 AvKARE, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 42291-164_62d7f61f-6e60-244c-e053-2991aa0afca5 42291-164 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20160315 ANDA ANDA040682 AvKARE, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 42291-165_62d7f61f-6e60-244c-e053-2991aa0afca5 42291-165 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20160315 ANDA ANDA040682 AvKARE, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 42291-167_630f667f-4f96-5f35-e053-2991aa0a0779 42291-167 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET ORAL 20170412 ANDA ANDA204741 AvKARE, Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 42291-168_62fcbe3d-5aec-8dd2-e053-2a91aa0a5f6a 42291-168 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20140113 ANDA ANDA076932 AvKARE, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20191231 42291-169_50dca1e3-7983-134c-824f-6fff9f0110a4 42291-169 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 AvKARE, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 42291-170_50dca1e3-7983-134c-824f-6fff9f0110a4 42291-170 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20100401 ANDA ANDA040855 AvKARE, Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 42291-174_62fd8561-2fcd-91d7-e053-2a91aa0a0696 42291-174 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130401 ANDA ANDA203136 AvKARE, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 42291-175_62fd8561-2fcd-91d7-e053-2a91aa0a0696 42291-175 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130401 ANDA ANDA203136 AvKARE, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 42291-176_630ed382-c138-4174-e053-2991aa0aed86 42291-176 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20130828 ANDA ANDA075467 AvKARE, Inc. BUSPIRONE HYDROCHLORIDE 7.5 mg/1 N 20191231 42291-177_630f1987-a806-c6ab-e053-2991aa0a0004 42291-177 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20131017 ANDA ANDA075022 AvKARE, Inc. BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20191231 42291-178_630f1286-2199-52c2-e053-2991aa0a512a 42291-178 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20150126 ANDA ANDA074225 AvKARE, Inc. BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 42291-179_630f1286-2199-52c2-e053-2991aa0a512a 42291-179 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20150126 ANDA ANDA074225 AvKARE, Inc. BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 42291-180_630f1286-2199-52c2-e053-2991aa0a512a 42291-180 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20150126 ANDA ANDA074225 AvKARE, Inc. BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 42291-181_630f3a54-9b10-e172-e053-2991aa0ac772 42291-181 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine CAPSULE ORAL 20141124 ANDA ANDA040885 AvKARE, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 300; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20191231 42291-182_05fc3b0c-c34d-443d-596f-8a9e9559f641 42291-182 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160127 ANDA ANDA077284 AvKARE, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 42291-183_05fc3b0c-c34d-443d-596f-8a9e9559f641 42291-183 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160127 ANDA ANDA077284 AvKARE, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 42291-184_99066a41-2285-a6df-5e76-2d2b015e4ec2 42291-184 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20161005 ANDA ANDA074984 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 42291-185_99066a41-2285-a6df-5e76-2d2b015e4ec2 42291-185 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20161005 ANDA ANDA074984 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 42291-186_99066a41-2285-a6df-5e76-2d2b015e4ec2 42291-186 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 42291-187_99066a41-2285-a6df-5e76-2d2b015e4ec2 42291-187 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20161005 ANDA ANDA074984 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 42291-189_6300faad-1e2b-4d5e-e053-2991aa0ab935 42291-189 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20160615 ANDA ANDA201658 AvKARE, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20191231 42291-190_630f9bd2-452c-4225-e053-2991aa0ab54c 42291-190 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20150320 ANDA ANDA091649 AvKARE, Inc. CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 42291-191_630f9bd2-452c-4225-e053-2991aa0ab54c 42291-191 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20150320 ANDA ANDA091649 AvKARE, Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 42291-192_630fbd62-a890-424e-e053-2a91aa0a1be7 42291-192 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 AvKARE, Inc. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-193_630fbd62-a890-424e-e053-2a91aa0a1be7 42291-193 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 AvKARE, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-194_630fbd62-a890-424e-e053-2a91aa0a1be7 42291-194 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 AvKARE, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-195_630fbd62-a890-424e-e053-2a91aa0a1be7 42291-195 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 AvKARE, Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-206_63139afe-50e3-ae4a-e053-2991aa0a48f0 42291-206 HUMAN PRESCRIPTION DRUG Darifenacin Hydrobromide Extended-Release Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20170109 ANDA ANDA091190 AvKARE, Inc. DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 42291-207_63139afe-50e3-ae4a-e053-2991aa0a48f0 42291-207 HUMAN PRESCRIPTION DRUG Darifenacin Hydrobromide Extended-Release Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20170109 ANDA ANDA091190 AvKARE, Inc. DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 42291-208_63138e4a-bc84-48d8-e053-2a91aa0aaf20 42291-208 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110811 ANDA ANDA062713 AvKARE, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 42291-209_63138e4a-bc84-48d8-e053-2a91aa0aaf20 42291-209 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110811 ANDA ANDA062713 AvKARE, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 42291-210_cdec3afe-df82-8cae-ae49-ec5edefa1389 42291-210 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20020926 ANDA ANDA085461 AvKARE, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 42291-211_cdec3afe-df82-8cae-ae49-ec5edefa1389 42291-211 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20020926 ANDA ANDA085472 AvKARE, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 42291-212_cdec3afe-df82-8cae-ae49-ec5edefa1389 42291-212 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20020926 ANDA ANDA085475 AvKARE, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 42291-215_6313ee5d-fdb5-18b8-e053-2a91aa0a1f45 42291-215 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin phosphate SOLUTION TOPICAL 20150929 ANDA ANDA065184 AvKARE, Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 42291-216_33707632-09bc-4525-8abd-4e186eb7967b 42291-216 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20170330 ANDA ANDA062286 AvKARE, Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 42291-217_6313ee5d-fdf4-18b8-e053-2a91aa0a1f45 42291-217 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20160112 ANDA ANDA074151 AvKARE, Inc. CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 42291-218_6313ee5d-fdf4-18b8-e053-2a91aa0a1f45 42291-218 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20130723 ANDA ANDA074151 AvKARE, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 42291-219_6314c44a-c398-fa4c-e053-2a91aa0ae1b5 42291-219 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20140616 ANDA ANDA076126 AvKARE, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 42291-225_6314e1de-c555-43f4-e053-2991aa0a0d10 42291-225 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20100615 ANDA ANDA040644 AvKARE, Inc. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20191231 42291-229_4da8d556-0c74-2ec0-8065-27b63898f78f 42291-229 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20120705 ANDA ANDA078355 AvKARE, Inc. DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 42291-230_6324e226-ecf0-6a3d-e053-2a91aa0a0dac 42291-230 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20110922 ANDA ANDA075185 AvKARE, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-231_6324e226-ecf0-6a3d-e053-2a91aa0a0dac 42291-231 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20110922 ANDA ANDA075185 AvKARE, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-232_6324e226-ed28-6a3d-e053-2a91aa0a0dac 42291-232 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121214 ANDA ANDA201089 AvKARE, Inc. DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20191231 42291-233_6324e226-ed28-6a3d-e053-2a91aa0a0dac 42291-233 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121214 ANDA ANDA201089 AvKARE, Inc. DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20191231 42291-234_201650d3-2f6b-aaa6-5c13-8edff6813bd6 42291-234 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 20140103 ANDA ANDA070101 AvKARE, Inc. DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 42291-235_201650d3-2f6b-aaa6-5c13-8edff6813bd6 42291-235 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 20140103 ANDA ANDA070102 AvKARE, Inc. DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 42291-236_183de344-d0d0-0e30-9936-3da47254e30c 42291-236 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140109 ANDA ANDA075116 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 42291-237_183de344-d0d0-0e30-9936-3da47254e30c 42291-237 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140109 ANDA ANDA075116 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 42291-240_63251601-f1a1-bd56-e053-2a91aa0a3872 42291-240 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20151124 ANDA ANDA078355 AvKARE, Inc. DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 42291-243_63254869-67d3-0900-e053-2a91aa0af95c 42291-243 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20160223 ANDA ANDA074582 AvKARE, Inc. DANAZOL 200 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20191231 42291-244_625eed7a-4db1-6378-e053-2a91aa0a4145 42291-244 HUMAN PRESCRIPTION DRUG Donnatal phenobarbital elixir ELIXIR ORAL 20140113 UNAPPROVED DRUG OTHER AvKARE, Inc. PHENOBARBITAL; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; ATROPINE SULFATE 16.2; .1037; .0065; .0194 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 42291-245_ccec158d-edb4-5da0-d891-376de835259a 42291-245 HUMAN PRESCRIPTION DRUG Donnatal Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide TABLET ORAL 20140106 UNAPPROVED DRUG OTHER AvKARE, Inc. PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 42291-246_63254869-67d4-0900-e053-2a91aa0af95c 42291-246 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride donepezil hydrochloride TABLET, EXTENDED RELEASE ORAL 20150311 ANDA ANDA203104 AvKARE, Inc. DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20191231 42291-247_632580cf-8292-67cb-e053-2a91aa0ada90 42291-247 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20120831 ANDA ANDA071669 AvKARE, Inc. DOXEPIN HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20191231 42291-254_1c6fc83f-a414-e340-1ca1-d007a944a9cd 42291-254 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil TABLET, FILM COATED ORAL 20161115 ANDA ANDA203907 AvKARE, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 42291-255_1c6fc83f-a414-e340-1ca1-d007a944a9cd 42291-255 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil TABLET, FILM COATED ORAL 20161115 ANDA ANDA203907 AvKARE, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 42291-256_632580cf-829d-67cb-e053-2a91aa0ada90 42291-256 HUMAN PRESCRIPTION DRUG Diclofenac sodium Diclofenac GEL TOPICAL 20160831 ANDA ANDA208077 AvKARE, Inc. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-257_6325a66d-5bd5-2815-e053-2a91aa0a05df 42291-257 HUMAN PRESCRIPTION DRUG Dutasteride Dutasteride CAPSULE ORAL 20151130 ANDA ANDA203118 AvKARE, Inc. DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20191231 42291-258_6325a66d-5c1d-2815-e053-2a91aa0a05df 42291-258 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150409 ANDA ANDA075580 AvKARE, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 42291-259_6325a66d-5c1d-2815-e053-2a91aa0a05df 42291-259 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150409 ANDA ANDA075580 AvKARE, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 42291-260_6325a66d-5c1d-2815-e053-2a91aa0a05df 42291-260 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150409 ANDA ANDA075580 AvKARE, Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 42291-261_6325d560-cd4a-fc9b-e053-2991aa0a719e 42291-261 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20160224 ANDA ANDA206652 AvKARE, Inc. ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 42291-262_6325d560-cd4a-fc9b-e053-2991aa0a719e 42291-262 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20160224 ANDA ANDA206652 AvKARE, Inc. ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 42291-263_63262a47-d42f-ff7f-e053-2a91aa0af278 42291-263 HUMAN PRESCRIPTION DRUG clarithromycin clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170420 ANDA ANDA065145 AvKARE, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 42291-264_636137da-63e6-1e0b-e053-2991aa0a5d3e 42291-264 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline TABLET ORAL 20170427 ANDA ANDA065425 AvKARE, Inc. DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 42291-265_636137da-63e6-1e0b-e053-2991aa0a5d3e 42291-265 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline TABLET ORAL 20170427 ANDA ANDA065425 AvKARE, Inc. DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 42291-266_636120b7-3377-f26e-e053-2a91aa0a87dc 42291-266 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20150723 ANDA ANDA080704 AvKARE, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20191231 42291-268_63615537-08a3-7a91-e053-2991aa0a212f 42291-268 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20140620 NDA AUTHORIZED GENERIC NDA020796 AvKARE, Inc. ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20191231 42291-271_63615dd3-197b-46fe-e053-2a91aa0adb0c 42291-271 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140515 ANDA ANDA091169 AvKARE, Inc. ESZOPICLONE 1 mg/1 CIV N 20191231 42291-272_63615dd3-197b-46fe-e053-2a91aa0adb0c 42291-272 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140515 ANDA ANDA091169 AvKARE, Inc. ESZOPICLONE 2 mg/1 CIV N 20191231 42291-273_63615dd3-197b-46fe-e053-2a91aa0adb0c 42291-273 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140515 ANDA ANDA091169 AvKARE, Inc. ESZOPICLONE 3 mg/1 CIV N 20191231 42291-275_63615dd3-19af-46fe-e053-2a91aa0adb0c 42291-275 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20120104 ANDA ANDA077487 AvKARE, Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 42291-276_63615dd3-19af-46fe-e053-2a91aa0adb0c 42291-276 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20120104 ANDA ANDA077487 AvKARE, Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 42291-277_63615dd3-19af-46fe-e053-2a91aa0adb0c 42291-277 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20120104 ANDA ANDA077487 AvKARE, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 42291-280_6361db95-e3d1-4b99-e053-2991aa0a94fe 42291-280 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130226 ANDA ANDA076511 AvKARE, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20191231 42291-281_6361e5d8-267d-b2df-e053-2a91aa0a94c8 42291-281 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20130918 ANDA ANDA075805 AvKARE, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 42291-282_6361e5d8-267d-b2df-e053-2a91aa0a94c8 42291-282 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20151116 ANDA ANDA075805 AvKARE, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 42291-283_6362d23a-dff9-fc13-e053-2991aa0a50a0 42291-283 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL AURICULAR (OTIC) 20131218 ANDA ANDA091306 AvKARE, Inc. FLUOCINOLONE ACETONIDE .11 mg/20mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 42291-284_6362cf04-3d45-fe5f-e053-2991aa0a8f9c 42291-284 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20131217 ANDA ANDA201759 AvKARE, Inc. FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 42291-285_63634542-26c9-1482-e053-2a91aa0afa9d 42291-285 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20131217 ANDA ANDA201764 AvKARE, Inc. FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 42291-289_636340db-c521-7b5a-e053-2a91aa0a4902 42291-289 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20150331 ANDA ANDA076509 AvKARE, Inc. FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20191231 42291-290_636340db-c521-7b5a-e053-2a91aa0a4902 42291-290 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20150107 ANDA ANDA076509 AvKARE, Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20191231 42291-291_63639194-b5b0-c916-e053-2991aa0a4929 42291-291 HUMAN PRESCRIPTION DRUG FLUOXETINE fluoxetine hydrochloride CAPSULE ORAL 20160906 ANDA ANDA076922 AvKARE, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-292_636342f3-9a66-ba62-e053-2a91aa0ace17 42291-292 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20151214 ANDA ANDA201748 AvKARE, Inc. FENOFIBRATE 130 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20191231 42291-293_6363bd81-6e53-01c0-e053-2991aa0af8b2 42291-293 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20160622 ANDA ANDA075442 AvKARE, Inc. FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] N 20191231 42291-294_6363bd81-6e53-01c0-e053-2991aa0af8b2 42291-294 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20160622 ANDA ANDA075442 AvKARE, Inc. FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20191231 42291-295_6363bd81-6e53-01c0-e053-2991aa0af8b2 42291-295 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20160622 ANDA ANDA075442 AvKARE, Inc. FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] N 20191231 42291-296_636342f3-9a9f-ba62-e053-2a91aa0ace17 42291-296 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20151016 ANDA ANDA202039 AvKARE, Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20191231 42291-297_636342f3-9a9f-ba62-e053-2a91aa0ace17 42291-297 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20150501 ANDA ANDA202039 AvKARE, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20191231 42291-298_6364164c-f2ed-d007-e053-2991aa0a0115 42291-298 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20170517 ANDA ANDA204074 AvKARE, Inc. DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20191231 42291-299_6364164c-f2ed-d007-e053-2991aa0a0115 42291-299 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20170517 ANDA ANDA204074 AvKARE, Inc. DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20191231 42291-303_6364164c-f346-d007-e053-2991aa0a0115 42291-303 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20150514 ANDA ANDA090195 AvKARE, Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 42291-304_6364164c-f346-d007-e053-2991aa0a0115 42291-304 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20150514 ANDA ANDA090195 AvKARE, Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 42291-305_638a9f59-f182-d7cb-e053-2991aa0a6335 42291-305 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20130708 ANDA ANDA077270 AvKARE, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-306_638a9f59-f182-d7cb-e053-2991aa0a6335 42291-306 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20130708 ANDA ANDA077270 AvKARE, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-310_638ad65c-4cdc-2aa0-e053-2991aa0a01c4 42291-310 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 20110303 ANDA ANDA075109 AvKARE, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 42291-311_638ad65c-4cdc-2aa0-e053-2991aa0a01c4 42291-311 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 20110303 ANDA ANDA075109 AvKARE, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 42291-313_638aedd9-9773-4f3c-e053-2991aa0a301a 42291-313 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET ORAL 20131104 OTC MONOGRAPH FINAL part341 AvKARE, Inc. GUAIFENESIN 200 mg/1 N 20191231 42291-314_638ada23-7cbd-16dc-e053-2991aa0a1e99 42291-314 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20170615 ANDA ANDA208332 AvKARE, Inc. EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20191231 42291-315_638ada23-7cbf-16dc-e053-2991aa0a1e99 42291-315 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20160912 ANDA ANDA078391 AvKARE, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 42291-316_638aedd9-9782-4f3c-e053-2991aa0a301a 42291-316 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20140925 ANDA ANDA074388 AvKARE, Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 42291-317_638aedd9-9782-4f3c-e053-2991aa0a301a 42291-317 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20140925 ANDA ANDA074388 AvKARE, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 42291-318_53cbd6a7-1790-e92d-9b3c-9e4949f553f5 42291-318 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20140519 ANDA ANDA040766 AvKARE, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 42291-321_638b3ed3-fa64-43f6-e053-2991aa0a6bb0 42291-321 HUMAN PRESCRIPTION DRUG HYDROXYUREA Hydroxyurea CAPSULE ORAL 20130719 ANDA ANDA075143 AvKARE, Inc. HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] N 20191231 42291-322_638c16fe-8ddc-21b4-e053-2991aa0a47a0 42291-322 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20130307 ANDA ANDA040156 AvKARE, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20191231 42291-323_638c16fe-8ddc-21b4-e053-2991aa0a47a0 42291-323 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20130307 ANDA ANDA040156 AvKARE, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20191231 42291-324_638c341b-ecc4-4bd1-e053-2991aa0a5b52 42291-324 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20150707 ANDA ANDA200881 AvKARE, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 42291-325_638c341b-ecc4-4bd1-e053-2991aa0a5b52 42291-325 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20150707 ANDA ANDA200881 AvKARE, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 42291-326_638c341b-ecc4-4bd1-e053-2991aa0a5b52 42291-326 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20150707 ANDA ANDA200881 AvKARE, Inc. GUANFACINE HYDROCHLORIDE 3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 42291-327_638c341b-ecc4-4bd1-e053-2991aa0a5b52 42291-327 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20150707 ANDA ANDA200881 AvKARE, Inc. GUANFACINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 42291-328_f6df4f50-977f-c4aa-6e20-ad5155564b55 42291-328 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20160818 ANDA ANDA074984 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 42291-329_f6df4f50-977f-c4aa-6e20-ad5155564b55 42291-329 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20160818 ANDA ANDA074984 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 42291-330_f6df4f50-977f-c4aa-6e20-ad5155564b55 42291-330 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20160818 ANDA ANDA074984 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 42291-331_f6df4f50-977f-c4aa-6e20-ad5155564b55 42291-331 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20160818 ANDA ANDA074984 AvKARE, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 42291-332_638c2fd5-5de5-ac05-e053-2a91aa0aa8d8 42291-332 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160906 ANDA ANDA040736 AvKARE, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 42291-333_638c8369-e57e-cbb0-e053-2991aa0a0be2 42291-333 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160906 ANDA ANDA040746 AvKARE, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 42291-334_638c8369-e57e-cbb0-e053-2991aa0a0be2 42291-334 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160906 ANDA ANDA040746 AvKARE, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 42291-335_638d23db-c60e-1686-e053-2a91aa0a1df2 42291-335 HUMAN PRESCRIPTION DRUG Plaquenil Hydroxychloroquine Sulfate TABLET ORAL 20160714 NDA NDA009768 AvKARE, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20191231 42291-337_638d23db-c656-1686-e053-2a91aa0a1df2 42291-337 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130110 ANDA ANDA078558 AvKARE, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-338_638d23db-c656-1686-e053-2a91aa0a1df2 42291-338 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130110 ANDA ANDA078558 AvKARE, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-339_638d23db-c656-1686-e053-2a91aa0a1df2 42291-339 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20130110 ANDA ANDA078558 AvKARE, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-342_b9cb3dbe-46a0-f633-d163-c6fdc7845d78 42291-342 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20130926 ANDA ANDA077369 AvKARE, Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 42291-343_b9cb3dbe-46a0-f633-d163-c6fdc7845d78 42291-343 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20130926 ANDA ANDA077369 AvKARE, Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 42291-345_638d5769-6358-a4d1-e053-2991aa0a769e 42291-345 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20151209 ANDA ANDA040903 AvKARE, Inc. IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20191231 42291-346_638d5769-6358-a4d1-e053-2991aa0a769e 42291-346 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20151209 ANDA ANDA040903 AvKARE, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 42291-347_638d5769-6358-a4d1-e053-2991aa0a769e 42291-347 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20151209 ANDA ANDA040903 AvKARE, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 42291-348_638d41f7-997b-319a-e053-2a91aa0a5827 42291-348 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20160209 ANDA ANDA074722 AvKARE, Inc. INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20191231 42291-349_638d41f7-997b-319a-e053-2a91aa0a5827 42291-349 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20160209 ANDA ANDA074722 AvKARE, Inc. INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20191231 42291-350_638d8438-b8b8-f97b-e053-2991aa0a7661 42291-350 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20160607 ANDA ANDA087946 AvKARE, Inc. ISOSORBIDE DINITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 42291-351_18f775fc-58d1-2370-676c-02413acae7d8 42291-351 HUMAN PRESCRIPTION DRUG Imatinib Mesylate Imatinib Mesylate TABLET, FILM COATED ORAL 20160810 ANDA ANDA079179 AvKARE, Inc. IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 42291-352_18f775fc-58d1-2370-676c-02413acae7d8 42291-352 HUMAN PRESCRIPTION DRUG Imatinib Mesylate Imatinib Mesylate TABLET, FILM COATED ORAL 20160810 ANDA ANDA079179 AvKARE, Inc. IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 42291-353_638d8438-b8c9-f97b-e053-2991aa0a7661 42291-353 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20170331 ANDA ANDA076420 AvKARE, Inc. LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 42291-354_638d8438-b8c9-f97b-e053-2991aa0a7661 42291-354 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20170331 ANDA ANDA076420 AvKARE, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 42291-358_638d8438-b939-f97b-e053-2991aa0a7661 42291-358 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20160725 ANDA ANDA074754 AvKARE, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20191231 42291-363_638dbc25-4869-3d56-e053-2a91aa0a9554 42291-363 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20131016 ANDA ANDA079081 AvKARE, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 42291-364_639b0107-19bb-4787-e053-2991aa0aa8a3 42291-364 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130805 ANDA ANDA077255 AvKARE, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20191231 42291-365_639b0107-19bb-4787-e053-2991aa0aa8a3 42291-365 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130805 ANDA ANDA077255 AvKARE, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20191231 42291-366_63651522-9c53-2cda-e053-2991aa0ac6da 42291-366 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130403 ANDA ANDA079132 AvKARE, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 42291-367_63651522-9c53-2cda-e053-2991aa0ac6da 42291-367 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130403 ANDA ANDA079132 AvKARE, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 42291-368_63651522-9c53-2cda-e053-2991aa0ac6da 42291-368 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130403 ANDA ANDA079132 AvKARE, Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 42291-369_63651522-9c53-2cda-e053-2991aa0ac6da 42291-369 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130403 ANDA ANDA079132 AvKARE, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 42291-374_639c5c68-9649-3ab4-e053-2991aa0a3e8e 42291-374 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20150102 ANDA ANDA090289 AvKARE, Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20191231 42291-376_63ec2890-5746-387b-e053-2a91aa0a7051 42291-376 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110303 ANDA ANDA075991 AvKARE, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 42291-377_63ec2890-5746-387b-e053-2a91aa0a7051 42291-377 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110303 ANDA ANDA075991 AvKARE, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 42291-379_639e6875-ec02-7bbe-e053-2a91aa0a4ad8 42291-379 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20160927 ANDA ANDA206297 AvKARE, Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 42291-386_639f9d57-f258-708a-e053-2a91aa0a6962 42291-386 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20170616 ANDA ANDA203646 AvKARE, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 42291-387_639ecbfc-5070-680b-e053-2991aa0adb10 42291-387 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160728 ANDA ANDA202167 AvKARE, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 42291-388_639ecbfc-5070-680b-e053-2991aa0adb10 42291-388 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160728 ANDA ANDA202167 AvKARE, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 42291-390_c80628b9-bdd4-b3aa-a1b0-3ee57cef9c63 42291-390 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20130618 ANDA ANDA076262 AvKARE, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 42291-391_c80628b9-bdd4-b3aa-a1b0-3ee57cef9c63 42291-391 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20130618 ANDA ANDA076262 AvKARE, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 42291-392_c80628b9-bdd4-b3aa-a1b0-3ee57cef9c63 42291-392 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20130618 ANDA ANDA076262 AvKARE, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 42291-396_648ddde4-3d37-4c8b-e053-2a91aa0a1943 42291-396 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20170814 ANDA ANDA076001 AvKARE, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-397_648ddde4-3d37-4c8b-e053-2a91aa0a1943 42291-397 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20170814 ANDA ANDA076001 AvKARE, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-398_fe4bbb93-1d36-4df7-b80c-329ba9296520 42291-398 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20170814 ANDA ANDA075452 AvKARE, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42291-404_639fcfbf-b4a5-749b-e053-2a91aa0a9d0e 42291-404 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20170105 ANDA ANDA075419 AvKARE, Inc. ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-405_639fcfbf-b4a5-749b-e053-2a91aa0a9d0e 42291-405 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20170105 ANDA ANDA075419 AvKARE, Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-509_fed03fd2-a14f-559a-1beb-78af955e3d4a 42291-509 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20080424 ANDA ANDA040866 AvKARE, Inc. PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 42291-511_fed03fd2-a14f-559a-1beb-78af955e3d4a 42291-511 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20080424 ANDA ANDA040866 AvKARE, Inc. PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 42291-512_63a0189b-1147-838e-e053-2991aa0a8dc2 42291-512 HUMAN PRESCRIPTION DRUG Pioglitazone and Metformin Hydrochloride Pioglitazone and Metformin Hydrochloride TABLET, FILM COATED ORAL 20150306 ANDA ANDA091155 AvKARE, Inc. PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 500 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-513_63a0189b-1147-838e-e053-2991aa0a8dc2 42291-513 HUMAN PRESCRIPTION DRUG Pioglitazone and Metformin Hydrochloride Pioglitazone and Metformin Hydrochloride TABLET, FILM COATED ORAL 20150306 ANDA ANDA091155 AvKARE, Inc. PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 850 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-516_636556f6-2989-984f-e053-2991aa0a201a 42291-516 HUMAN PRESCRIPTION DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET ORAL 20171030 ANDA ANDA078432 AvKARE, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-517_636556f6-2989-984f-e053-2991aa0a201a 42291-517 HUMAN PRESCRIPTION DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET ORAL 20171030 ANDA ANDA078432 AvKARE, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-522_63a0189b-11ae-838e-e053-2991aa0a8dc2 42291-522 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170516 ANDA ANDA078703 AvKARE, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 42291-523_63a0189b-11ae-838e-e053-2991aa0a8dc2 42291-523 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170516 ANDA ANDA078703 AvKARE, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 42291-524_63a0189b-11ae-838e-e053-2991aa0a8dc2 42291-524 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170516 ANDA ANDA078703 AvKARE, Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 42291-525_63a0189b-11ae-838e-e053-2991aa0a8dc2 42291-525 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170516 ANDA ANDA078703 AvKARE, Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 42291-529_63a05100-afa8-d693-e053-2991aa0a80a2 42291-529 HUMAN PRESCRIPTION DRUG FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE TABLET ORAL 20091020 ANDA ANDA040431 AvKARE, Inc. FLUDROCORTISONE ACETATE .1 mg/1 N 20191231 42291-531_593f3040-93e0-9248-bef4-c01c20863194 42291-531 HUMAN PRESCRIPTION DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET ORAL 20070426 ANDA ANDA078432 AvKARE, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42291-532_593f3040-93e0-9248-bef4-c01c20863194 42291-532 HUMAN PRESCRIPTION DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET ORAL 20070426 ANDA ANDA078432 AvKARE, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42291-534_0505e0b2-667e-6b32-b503-09509b717c34 42291-534 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE PRAMIPEXOLE TABLET ORAL 20160727 ANDA ANDA203855 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 42291-535_0505e0b2-667e-6b32-b503-09509b717c34 42291-535 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE PRAMIPEXOLE TABLET ORAL 20160727 ANDA ANDA203855 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 42291-536_0505e0b2-667e-6b32-b503-09509b717c34 42291-536 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE PRAMIPEXOLE TABLET ORAL 20160727 ANDA ANDA203855 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 42291-537_0505e0b2-667e-6b32-b503-09509b717c34 42291-537 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE PRAMIPEXOLE TABLET ORAL 20160727 ANDA ANDA203855 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 42291-538_0505e0b2-667e-6b32-b503-09509b717c34 42291-538 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE PRAMIPEXOLE TABLET ORAL 20160727 ANDA ANDA203855 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 42291-539_0505e0b2-667e-6b32-b503-09509b717c34 42291-539 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE PRAMIPEXOLE TABLET ORAL 20160727 ANDA ANDA203855 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 42291-545_63a0aa73-e0c3-60b9-e053-2a91aa0ae99f 42291-545 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160121 ANDA ANDA078540 AvKARE, Inc. PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] N 20191231 42291-546_63a0aa73-e0c3-60b9-e053-2a91aa0ae99f 42291-546 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160121 ANDA ANDA078540 AvKARE, Inc. PROPAFENONE HYDROCHLORIDE 325 mg/1 Antiarrhythmic [EPC] N 20191231 42291-547_63a0aa73-e0c3-60b9-e053-2a91aa0ae99f 42291-547 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160121 ANDA ANDA078540 AvKARE, Inc. PROPAFENONE HYDROCHLORIDE 425 mg/1 Antiarrhythmic [EPC] N 20191231 42291-548_63ae6bb0-0f09-ce3c-e053-2991aa0a5866 42291-548 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20151007 UNAPPROVED DRUG OTHER AvKARE, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20191231 42291-549_63ae6bb0-0f09-ce3c-e053-2991aa0a5866 42291-549 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20151007 UNAPPROVED DRUG OTHER AvKARE, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20191231 42291-551_63afa56f-1ed2-5371-e053-2a91aa0a9e7e 42291-551 HUMAN PRESCRIPTION DRUG Memantine hydrochloride Memantine TABLET, FILM COATED ORAL 20160111 ANDA ANDA090041 AvKARE, Inc. MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 42291-552_63afa56f-1ed2-5371-e053-2a91aa0a9e7e 42291-552 HUMAN PRESCRIPTION DRUG Memantine hydrochloride Memantine TABLET, FILM COATED ORAL 20160111 ANDA ANDA090041 AvKARE, Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 42291-554_63afbabb-815b-3f60-e053-2991aa0ae50c 42291-554 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole TABLET, EXTENDED RELEASE ORAL 20161123 ANDA ANDA202206 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 42291-555_63afbabb-815b-3f60-e053-2991aa0ae50c 42291-555 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole TABLET, EXTENDED RELEASE ORAL 20161123 ANDA ANDA202206 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 42291-556_63afbabb-815b-3f60-e053-2991aa0ae50c 42291-556 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole TABLET, EXTENDED RELEASE ORAL 20161123 ANDA ANDA202206 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 42291-557_63afbabb-815b-3f60-e053-2991aa0ae50c 42291-557 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Extended-Release Pramipexole TABLET, EXTENDED RELEASE ORAL 20160705 ANDA ANDA202206 AvKARE, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 4.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 42291-558_63afbabb-815f-3f60-e053-2991aa0ae50c 42291-558 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171121 ANDA ANDA203755 AvKARE, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-559_63afbabb-815f-3f60-e053-2991aa0ae50c 42291-559 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171121 ANDA ANDA203755 AvKARE, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-560_c0ce117a-12b7-4d94-a104-f062857a7e06 42291-560 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20170505 ANDA ANDA077746 AvKARE, Inc. MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 42291-561_c0ce117a-12b7-4d94-a104-f062857a7e06 42291-561 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20170505 ANDA ANDA077746 AvKARE, Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 42291-562_c0ce117a-12b7-4d94-a104-f062857a7e06 42291-562 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20170505 ANDA ANDA077746 AvKARE, Inc. MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 42291-574_63b01854-c9e2-508a-e053-2a91aa0a2c4a 42291-574 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin monohydrate/macrocrystals CAPSULE ORAL 20171031 ANDA ANDA207372 AvKARE, Inc. NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20191231 42291-576_63b63711-ed6d-be1f-e053-2991aa0a0390 42291-576 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170403 ANDA ANDA076980 AvKARE, Inc. MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 7.5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 42291-577_63b63711-ed6d-be1f-e053-2991aa0a0390 42291-577 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170403 ANDA ANDA076980 AvKARE, Inc. MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 15; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 42291-578_63b63711-ed6d-be1f-e053-2991aa0a0390 42291-578 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170403 ANDA ANDA076980 AvKARE, Inc. MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 15; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 42291-579_63b64fb5-dd48-ca67-e053-2a91aa0a2b3d 42291-579 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161102 ANDA ANDA204744 AvKARE, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-580_63b64fb5-dd48-ca67-e053-2a91aa0a2b3d 42291-580 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161102 ANDA ANDA204744 AvKARE, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-581_63b64fb5-dd48-ca67-e053-2a91aa0a2b3d 42291-581 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161102 ANDA ANDA204744 AvKARE, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-582_63b63711-edbe-be1f-e053-2991aa0a0390 42291-582 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170113 ANDA ANDA090692 AvKARE, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-583_63b63711-edbe-be1f-e053-2991aa0a0390 42291-583 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170113 ANDA ANDA090692 AvKARE, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-584_63b668ba-7a0e-2a10-e053-2a91aa0ae4e1 42291-584 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20160826 ANDA ANDA076378 AvKARE, Inc. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20191231 42291-586_63b668ba-7a0e-2a10-e053-2a91aa0ae4e1 42291-586 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20160826 ANDA ANDA076250 AvKARE, Inc. NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20191231 42291-587_63b668ba-7a11-2a10-e053-2a91aa0ae4e1 42291-587 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20150522 ANDA ANDA203399 AvKARE, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20191231 42291-588_64152539-60dc-dc7d-a609-6f400e855613 42291-588 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20160609 ANDA ANDA203139 AvKARE, Inc. MEGESTROL ACETATE 125 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 42291-589_63eb84ae-8780-4c3a-e053-2a91aa0a8dab 42291-589 HUMAN PRESCRIPTION DRUG Minocycline Minocycline TABLET ORAL 20150508 ANDA ANDA065131 AvKARE, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 42291-591_63eb84ae-8780-4c3a-e053-2a91aa0a8dab 42291-591 HUMAN PRESCRIPTION DRUG Minocycline Minocycline TABLET ORAL 20150508 ANDA ANDA065131 AvKARE, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 42291-592_059beca0-37b6-54cb-2789-6a234fda6bbc 42291-592 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141204 ANDA ANDA090692 AvKARE, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 42291-593_059beca0-37b6-54cb-2789-6a234fda6bbc 42291-593 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141204 ANDA ANDA090692 AvKARE, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 42291-594_63ec2890-57ab-387b-e053-2a91aa0a7051 42291-594 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate TABLET ORAL 20141120 ANDA ANDA081099 AvKARE, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20191231 42291-595_63ec845d-2554-ec8a-e053-2991aa0ae85c 42291-595 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20140930 ANDA ANDA072801 AvKARE, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20191231 42291-596_63ec845d-2554-ec8a-e053-2991aa0ae85c 42291-596 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20140930 ANDA ANDA070184 AvKARE, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20191231 42291-599_63ec845d-25ae-ec8a-e053-2991aa0ae85c 42291-599 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20140224 ANDA ANDA076715 AvKARE, Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20191231 42291-600_63ec845d-25ae-ec8a-e053-2991aa0ae85c 42291-600 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20140224 ANDA ANDA076715 AvKARE, Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20191231 42291-605_647f546e-43a5-2061-e053-2991aa0a2646 42291-605 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120626 ANDA ANDA077880 AvKARE, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-606_647f546e-43a5-2061-e053-2991aa0a2646 42291-606 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120626 ANDA ANDA077880 AvKARE, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-607_647f546e-43a5-2061-e053-2991aa0a2646 42291-607 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120626 ANDA ANDA077880 AvKARE, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-609_63ecbc76-268d-0b2a-e053-2991aa0a8d74 42291-609 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120504 ANDA ANDA201451 AvKARE, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20191231 42291-610_63ecf18e-2b44-e80e-e053-2991aa0ad9e7 42291-610 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101004 ANDA ANDA078596 AvKARE, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-611_63ecf18e-2b44-e80e-e053-2991aa0ad9e7 42291-611 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101004 ANDA ANDA078596 AvKARE, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 42291-616_000f3e36-1ed9-34da-136e-a3fcca51532a 42291-616 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20040527 ANDA ANDA076449 AvKARE, Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 42291-618_63ed3fb4-3d17-fbc2-e053-2991aa0ac078 42291-618 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20130801 ANDA ANDA072708 AvKARE, Inc. MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 42291-619_63ed3fb4-3d17-fbc2-e053-2991aa0ac078 42291-619 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20130801 ANDA ANDA072709 AvKARE, Inc. MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 42291-620_63ed9a8e-4dd6-8438-e053-2991aa0a1f1c 42291-620 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20110726 ANDA ANDA065062 AvKARE, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 42291-621_63ee5ac5-eb7e-740d-e053-2991aa0aa940 42291-621 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120810 ANDA ANDA201522 AvKARE, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 42291-622_63ee5ac5-eb7e-740d-e053-2991aa0aa940 42291-622 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20130102 ANDA ANDA200405 AvKARE, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 42291-623_63ee5ac5-eb7e-740d-e053-2991aa0aa940 42291-623 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20130102 ANDA ANDA200405 AvKARE, Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 42291-624_63ee8ac6-5b27-54b3-e053-2a91aa0afb74 42291-624 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20130709 ANDA ANDA074377 AvKARE, Inc. MEXILETINE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] N 20191231 42291-625_63ee8ac6-5b27-54b3-e053-2a91aa0afb74 42291-625 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20130709 ANDA ANDA074377 AvKARE, Inc. MEXILETINE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC] N 20191231 42291-626_63ee8ac6-5b27-54b3-e053-2a91aa0afb74 42291-626 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20130709 ANDA ANDA074377 AvKARE, Inc. MEXILETINE HYDROCHLORIDE 250 mg/1 Antiarrhythmic [EPC] N 20191231 42291-627_63eeb117-0127-1cfa-e053-2991aa0af395 42291-627 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20130730 ANDA ANDA076037 AvKARE, Inc. NEFAZODONE HYDROCHLORIDE 250 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 42291-628_76b31c11-832e-b485-379b-0082fc067b5d 42291-628 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130926 ANDA ANDA075927 AvKARE, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42291-629_47cb2cb9-df61-4e7d-84ca-ff1264ceac80 42291-629 HUMAN PRESCRIPTION DRUG Naproxen delayed release Naproxen TABLET, DELAYED RELEASE ORAL 20131024 ANDA ANDA091432 AvKARE, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42291-630_47cb2cb9-df61-4e7d-84ca-ff1264ceac80 42291-630 HUMAN PRESCRIPTION DRUG Naproxen delayed release Naproxen TABLET, DELAYED RELEASE ORAL 20131024 ANDA ANDA091432 AvKARE, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42291-631_63eeb117-0127-1cfa-e053-2991aa0af395 42291-631 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20131216 ANDA ANDA076037 AvKARE, Inc. NEFAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 42291-632_63ef0555-9bcf-4d21-e053-2991aa0aa9f9 42291-632 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20150326 ANDA ANDA075274 AvKARE, Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20191231 42291-633_640111b2-ce2b-7f6c-e053-2991aa0a3732 42291-633 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20160309 ANDA ANDA078503 AvKARE, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 42291-634_640111b2-ce2b-7f6c-e053-2991aa0a3732 42291-634 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20160309 ANDA ANDA078503 AvKARE, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 42291-635_640111b2-ce2b-7f6c-e053-2991aa0a3732 42291-635 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20160309 ANDA ANDA078503 AvKARE, Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 42291-636_64013c34-a944-06c5-e053-2a91aa0a19e5 42291-636 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20160406 ANDA ANDA077463 AvKARE, Inc. NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20191231 42291-637_64013c34-a944-06c5-e053-2a91aa0a19e5 42291-637 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20160406 ANDA ANDA077463 AvKARE, Inc. NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20191231 42291-645_74cb5a17-cb06-f116-d262-8883e70891fa 42291-645 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20160218 ANDA ANDA040777 AvKARE, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42291-646_abf46cd2-36b0-e7a2-3ebf-3c6fa751bf12 42291-646 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20160218 ANDA ANDA040778 AvKARE, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42291-648_64013c34-a989-06c5-e053-2a91aa0a19e5 42291-648 HUMAN PRESCRIPTION DRUG Nitroglycerin ER Nitroglycerin CAPSULE ORAL 20121219 UNAPPROVED DRUG OTHER AvKARE, Inc. NITROGLYCERIN 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 42291-649_64013c34-a989-06c5-e053-2a91aa0a19e5 42291-649 HUMAN PRESCRIPTION DRUG Nitroglycerin ER Nitroglycerin CAPSULE ORAL 20121219 UNAPPROVED DRUG OTHER AvKARE, Inc. NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 42291-650_64015b23-b8e7-866a-e053-2991aa0ad353 42291-650 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone TABLET ORAL 20130618 ANDA ANDA200275 AvKARE, Inc. NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20191231 42291-651_64015b23-b8ff-866a-e053-2991aa0ad353 42291-651 HUMAN PRESCRIPTION DRUG Nystatin Nystatin TABLET, FILM COATED ORAL 20140120 ANDA ANDA062506 AvKARE, Inc. NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20191231 42291-652_64015b23-b968-866a-e053-2991aa0ad353 42291-652 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20140121 ANDA ANDA202074 AvKARE, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 3; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-653_64015b23-b968-866a-e053-2991aa0ad353 42291-653 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20140121 ANDA ANDA077528 AvKARE, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 6; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-654_64015b23-b968-866a-e053-2991aa0ad353 42291-654 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20140121 ANDA ANDA077528 AvKARE, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 6; 50 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-655_64015b23-b968-866a-e053-2991aa0ad353 42291-655 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20140121 ANDA ANDA077528 AvKARE, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 12; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-656_64015b23-b968-866a-e053-2991aa0ad353 42291-656 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine Olanzapine and Fluoxetine CAPSULE ORAL 20140121 ANDA ANDA077528 AvKARE, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 12; 50 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-657_647f78f1-68ae-25aa-e053-2991aa0aaf5a 42291-657 HUMAN PRESCRIPTION DRUG Omega-3-acid ethyl esters Omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20150507 ANDA ANDA090973 AvKARE, Inc. OMEGA-3-ACID ETHYL ESTERS 1 g/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20191231 42291-658_64018103-5250-866c-e053-2991aa0a947c 42291-658 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20160222 ANDA ANDA077056 AvKARE, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 42291-659_64018103-5250-866c-e053-2991aa0a947c 42291-659 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20160222 ANDA ANDA077056 AvKARE, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 42291-662_6401a80f-1c68-28ad-e053-2a91aa0ac86f 42291-662 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20140306 ANDA ANDA075844 AvKARE, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-664_647f8236-af00-684d-e053-2991aa0adb1f 42291-664 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir CAPSULE ORAL 20170808 ANDA ANDA209093 AvKARE, Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 N 20191231 42291-665_6401bc39-2f6a-d23d-e053-2991aa0a6cdb 42291-665 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140617 ANDA ANDA076056 AvKARE, Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 42291-666_647f8236-af00-684d-e053-2991aa0adb1f 42291-666 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir CAPSULE ORAL 20170808 ANDA ANDA209093 AvKARE, Inc. OSELTAMIVIR PHOSPHATE 30 mg/1 N 20191231 42291-667_6401bc39-2f6a-d23d-e053-2991aa0a6cdb 42291-667 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140617 ANDA ANDA076056 AvKARE, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 42291-668_6401bc39-2f6a-d23d-e053-2991aa0a6cdb 42291-668 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140617 ANDA ANDA076056 AvKARE, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 42291-669_6401bc39-2f6a-d23d-e053-2991aa0a6cdb 42291-669 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140617 ANDA ANDA077793 AvKARE, Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 42291-673_648d9795-fda7-72e2-e053-2991aa0a0439 42291-673 HUMAN PRESCRIPTION DRUG POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 POWDER ORAL 20130705 ANDA ANDA076652 AvKARE, Inc. POLYETHYLENE GLYCOL 3350 1 g/g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20191231 42291-674_6401da8a-8cd4-72f6-e053-2991aa0ad5e0 42291-674 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20130627 ANDA ANDA074131 AvKARE, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-677_6401da8a-8cd4-72f6-e053-2991aa0ad5e0 42291-677 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20130627 ANDA ANDA074131 AvKARE, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42291-678_d4914702-6ee6-40f8-ff71-5456b4e3a610 42291-678 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20130305 ANDA ANDA077419 AvKARE, Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 42291-679_d4914702-6ee6-40f8-ff71-5456b4e3a610 42291-679 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20130305 ANDA ANDA077419 AvKARE, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 42291-686_07ae82ca-14c9-4b25-8611-43301014fbb7 42291-686 HUMAN PRESCRIPTION DRUG PRENATAL PLUS VITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE TABLET, FILM COATED ORAL 20120911 UNAPPROVED DRUG OTHER AvKARE, Inc. VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE 3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 42291-690_648d7960-a68d-1558-e053-2a91aa0a0b51 42291-690 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20140929 ANDA ANDA200900 AvKARE, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20191231 42291-691_648d7960-a68d-1558-e053-2a91aa0a0b51 42291-691 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20140929 ANDA ANDA200900 AvKARE, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20191231 42291-692_d5137205-7f71-4b6d-a4a3-bf60440e6390 42291-692 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20170323 ANDA ANDA078745 AvKARE, Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 42291-721_64020bf8-b736-80d2-e053-2991aa0abb1a 42291-721 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131223 ANDA ANDA076822 AvKARE, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 42291-722_64021f1a-c753-6ed1-e053-2991aa0a29b2 42291-722 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131219 ANDA ANDA090678 AvKARE, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 42291-724_72cf32f2-a75d-22ed-7150-b8124853693d 42291-724 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20140818 ANDA ANDA077824 AvKARE, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 42291-725_72cf32f2-a75d-22ed-7150-b8124853693d 42291-725 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20140818 ANDA ANDA077824 AvKARE, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 42291-726_64025494-70ec-61bb-e053-2a91aa0ad626 42291-726 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20141103 ANDA ANDA078193 AvKARE, Inc. RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20191231 42291-735_641729a3-6df8-3a2f-e053-2991aa0a015e 42291-735 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 20170331 ANDA ANDA075742 AvKARE, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 42291-736_641729a3-6df8-3a2f-e053-2991aa0a015e 42291-736 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 20170331 ANDA ANDA075742 AvKARE, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 42291-742_6403fc64-f4dd-57d1-e053-2a91aa0a0140 42291-742 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET ORAL 20160722 ANDA ANDA079168 AvKARE, Inc. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 42291-743_6403fc64-f4dd-57d1-e053-2a91aa0a0140 42291-743 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET ORAL 20160722 ANDA ANDA079168 AvKARE, Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 42291-744_6403fc64-f4dd-57d1-e053-2a91aa0a0140 42291-744 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET ORAL 20160722 ANDA ANDA079168 AvKARE, Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 42291-745_6403fc64-f4dd-57d1-e053-2a91aa0a0140 42291-745 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET ORAL 20160722 ANDA ANDA079168 AvKARE, Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 42291-749_0649e026-590a-44aa-be62-b3fee9ed9190 42291-749 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20170302 ANDA ANDA091379 AvKARE, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 42291-757_64042a3b-cfd7-3c09-e053-2991aa0a0077 42291-757 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20140117 ANDA ANDA070848 AvKARE, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20191231 42291-758_6404695c-2caf-97f7-e053-2a91aa0af1a5 42291-758 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20150805 ANDA ANDA076899 AvKARE, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 42291-759_6404695c-2caf-97f7-e053-2a91aa0af1a5 42291-759 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20150805 ANDA ANDA076899 AvKARE, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 42291-763_63b1bc36-f19b-287e-e053-2991aa0a80cb 42291-763 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate Sevelamer Carbonate TABLET, FILM COATED ORAL 20171110 ANDA ANDA090975 AvKARE, Inc. SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20191231 42291-790_63b05a77-a281-233a-e053-2a91aa0a7cca 42291-790 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20171213 ANDA ANDA204415 AvKARE, Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 42291-791_63b05a77-a281-233a-e053-2a91aa0a7cca 42291-791 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20171213 ANDA ANDA204415 AvKARE, Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 42291-792_63b05a77-a281-233a-e053-2a91aa0a7cca 42291-792 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20171213 ANDA ANDA204415 AvKARE, Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 42291-793_64049ddd-4d32-f644-e053-2a91aa0a714d 42291-793 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA201586 AvKARE, Inc. TELMISARTAN; AMLODIPINE BESYLATE 40; 5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 42291-794_64049ddd-4d32-f644-e053-2a91aa0a714d 42291-794 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20170809 ANDA ANDA201586 AvKARE, Inc. TELMISARTAN; AMLODIPINE BESYLATE 40; 10 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 42291-795_64049ddd-4d32-f644-e053-2a91aa0a714d 42291-795 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20170809 ANDA ANDA201586 AvKARE, Inc. TELMISARTAN; AMLODIPINE BESYLATE 80; 5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 42291-796_64049ddd-4d32-f644-e053-2a91aa0a714d 42291-796 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20170809 ANDA ANDA201586 AvKARE, Inc. TELMISARTAN; AMLODIPINE BESYLATE 80; 10 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 42291-797_64049ddd-4d4a-f644-e053-2a91aa0a714d 42291-797 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20150825 ANDA ANDA078581 AvKARE, Inc. TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20191231 42291-798_6404dc48-8f33-0009-e053-2991aa0af3c3 42291-798 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20131018 NDA NDA050278 AvKARE, Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 42291-799_6404dc48-8f33-0009-e053-2991aa0af3c3 42291-799 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20131018 NDA NDA050278 AvKARE, Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 42291-805_6404a061-67bd-f72c-e053-2a91aa0a37de 42291-805 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20111020 ANDA ANDA077919 AvKARE, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20191231 42291-806_6404aff5-b168-f642-e053-2a91aa0aadf5 42291-806 HUMAN PRESCRIPTION DRUG Tetrabenazine Tetrabenazine TABLET ORAL 20170208 ANDA ANDA207682 AvKARE, Inc. TETRABENAZINE 12.5 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20191231 42291-807_6404aff5-b168-f642-e053-2a91aa0aadf5 42291-807 HUMAN PRESCRIPTION DRUG Tetrabenazine Tetrabenazine TABLET ORAL 20170208 ANDA ANDA207682 AvKARE, Inc. TETRABENAZINE 25 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20191231 42291-808_64178c19-8915-129f-e053-2991aa0ab401 42291-808 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20150723 ANDA ANDA076416 AvKARE, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 42291-809_64178c19-8915-129f-e053-2991aa0ab401 42291-809 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20150723 ANDA ANDA076416 AvKARE, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 42291-810_6418cde9-607d-4ca1-e053-2991aa0a9170 42291-810 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20140620 ANDA ANDA078868 AvKARE, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 42291-811_6418cde9-607d-4ca1-e053-2991aa0a9170 42291-811 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20140620 ANDA ANDA078868 AvKARE, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 42291-812_6418cde9-607d-4ca1-e053-2991aa0a9170 42291-812 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20140620 ANDA ANDA078868 AvKARE, Inc. TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 42291-813_0f7bb78d-493b-c5d9-614b-420bd8e47b28 42291-813 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20141215 ANDA ANDA089807 AvKARE, Inc. THEOPHYLLINE ANHYDROUS 100 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 42291-814_0f7bb78d-493b-c5d9-614b-420bd8e47b28 42291-814 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20141215 ANDA ANDA089808 AvKARE, Inc. THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 42291-815_0f7bb78d-493b-c5d9-614b-420bd8e47b28 42291-815 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20141215 ANDA ANDA089763 AvKARE, Inc. THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 42291-816_6418d3ff-63a2-391f-e053-2a91aa0a4b15 42291-816 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20170403 ANDA ANDA076346 AvKARE, Inc. TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 42291-817_6418d3ff-63a2-391f-e053-2a91aa0a4b15 42291-817 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20170403 ANDA ANDA076346 AvKARE, Inc. TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 42291-818_6418d3ff-63a2-391f-e053-2a91aa0a4b15 42291-818 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20170403 ANDA ANDA076346 AvKARE, Inc. TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 42291-819_6418d3ff-63a2-391f-e053-2a91aa0a4b15 42291-819 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20141230 ANDA ANDA076346 AvKARE, Inc. TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 42291-832_64190477-d1a2-bf97-e053-2991aa0af84f 42291-832 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20150327 ANDA ANDA090485 AvKARE, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20191231 42291-833_64193aef-d6cb-ff7e-e053-2991aa0a3ed4 42291-833 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20140206 ANDA ANDA071523 AvKARE, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 42291-834_64193aef-d6cb-ff7e-e053-2991aa0a3ed4 42291-834 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20140206 ANDA ANDA071524 AvKARE, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 42291-835_64193aef-d6cb-ff7e-e053-2991aa0a3ed4 42291-835 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20140206 ANDA ANDA071525 AvKARE, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 42291-836_64193aef-d6cb-ff7e-e053-2991aa0a3ed4 42291-836 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20140206 ANDA ANDA071196 AvKARE, Inc. TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 42291-840_648f10e3-4298-1ac9-e053-2991aa0a54e2 42291-840 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE TOPICAL 20120607 ANDA ANDA040771 AvKARE, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 42291-841_641a40f5-72e8-a761-e053-2a91aa0a7301 42291-841 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20120703 ANDA ANDA201407 AvKARE, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 42291-842_641b1012-3619-5063-e053-2991aa0a62b8 42291-842 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20141014 ANDA ANDA071251 AvKARE, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20191231 42291-843_641a319f-c8ac-6671-e053-2a91aa0a84d4 42291-843 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CAPSULE ORAL 20160902 ANDA ANDA201687 AvKARE, Inc. TRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 42291-845_641a1680-b694-73fb-e053-2a91aa0a208f 42291-845 HUMAN PRESCRIPTION DRUG Trimethoprim trimethoprim TABLET ORAL 20130506 ANDA ANDA091437 AvKARE, Inc. TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 42291-846_0d5b4c31-4333-8963-b3e4-77f03778777b 42291-846 HUMAN PRESCRIPTION DRUG TROSPIUM CHLORIDE TROSPIUM CHLORIDE TABLET ORAL 20161006 ANDA ANDA091513 AvKARE, Inc. TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 42291-849_6295e473-526b-1f28-e053-2a91aa0a3a83 42291-849 HUMAN PRESCRIPTION DRUG UREA UREA CREAM TOPICAL 20171106 UNAPPROVED DRUG OTHER AvKARE, Inc. UREA 40 g/100g N 20191231 42291-850_641a64da-2793-298a-e053-2991aa0ae8ed 42291-850 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20100716 ANDA ANDA075517 AvKARE, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20191231 42291-851_a3b763ae-903e-e88e-ce6e-0bd9d85776d7 42291-851 HUMAN PRESCRIPTION DRUG UroAv-81 Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate TABLET ORAL 20160202 UNAPPROVED DRUG OTHER AvKARE, Inc. METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE 81; 40.8; 32.4; 10.8; .12 mg/1; mg/1; mg/1; mg/1; mg/1 Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 42291-852_641afbd8-ef44-79a3-e053-2991aa0a861e 42291-852 HUMAN PRESCRIPTION DRUG UroAv-B Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate CAPSULE ORAL 20160325 UNAPPROVED DRUG OTHER AvKARE, Inc. METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE 118; 40.8; 36; 10; .12 mg/1; mg/1; mg/1; mg/1; mg/1 Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20191231 42291-875_641a7be4-094c-1f65-e053-2a91aa0a259e 42291-875 HUMAN PRESCRIPTION DRUG Valganciclovir Valganciclovir hydrochloride TABLET, FILM COATED ORAL 20160621 ANDA ANDA200790 AvKARE, Inc. VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20191231 42291-884_647e795f-1ebc-a4b1-e053-2991aa0a485b 42291-884 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140908 ANDA ANDA091519 AvKARE, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 42291-885_647e795f-1ebc-a4b1-e053-2991aa0a485b 42291-885 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140908 ANDA ANDA091519 AvKARE, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 42291-886_647e795f-1ebc-a4b1-e053-2991aa0a485b 42291-886 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140908 ANDA ANDA091519 AvKARE, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 42291-887_647e795f-1ebc-a4b1-e053-2991aa0a485b 42291-887 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140908 ANDA ANDA091519 AvKARE, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 42291-888_647e795f-1ebc-a4b1-e053-2991aa0a485b 42291-888 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20140908 ANDA ANDA091519 AvKARE, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 42291-892_641aae9c-3c5d-74e5-e053-2a91aa0a86cb 42291-892 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-893_641aae9c-3c5d-74e5-e053-2a91aa0a86cb 42291-893 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-894_641aae9c-3c5d-74e5-e053-2a91aa0a86cb 42291-894 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-895_641aae9c-3c5d-74e5-e053-2a91aa0a86cb 42291-895 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-896_641aae9c-3c5d-74e5-e053-2a91aa0a86cb 42291-896 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 42291-897_b9390758-d291-8a10-e1b4-503c236c7cca 42291-897 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130710 ANDA ANDA076565 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42291-898_b9390758-d291-8a10-e1b4-503c236c7cca 42291-898 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130710 ANDA ANDA076565 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42291-899_b9390758-d291-8a10-e1b4-503c236c7cca 42291-899 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130710 ANDA ANDA076565 AvKARE, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42291-900_641af79f-51e2-6fd3-e053-2991aa0ad158 42291-900 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20160225 ANDA ANDA091658 AvKARE, Inc. VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 42291-962_648f10e3-4314-1ac9-e053-2991aa0a54e2 42291-962 HUMAN PRESCRIPTION DRUG Yuvafem Estradiol TABLET VAGINAL 20161019 ANDA ANDA205256 AvKARE, Inc. ESTRADIOL 10 ug/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20191231 42292-001_4fe11562-6fcd-4eb2-e054-00144ff88e88 42292-001 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150115 ANDA ANDA070044 Mylan Institutional Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 42292-002_414ac36a-cce9-19d2-e054-00144ff8d46c 42292-002 HUMAN PRESCRIPTION DRUG DIGITEK digoxin TABLET ORAL 20150506 ANDA ANDA040282 Mylan Institutional Inc. DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 42292-003_414ac36a-cce9-19d2-e054-00144ff8d46c 42292-003 HUMAN PRESCRIPTION DRUG DIGITEK digoxin TABLET ORAL 20150506 ANDA ANDA040282 Mylan Institutional Inc. DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 42292-004_21d59882-0da2-49f2-bcb5-60c3f431e181 42292-004 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150430 ANDA ANDA204662 Mylan Institutional Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 42292-005_ac79fd50-2ee6-4591-b983-024f26904de8 42292-005 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine TABLET ORAL 20150824 ANDA ANDA079225 Mylan Institutional Inc. MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 42292-006_ac79fd50-2ee6-4591-b983-024f26904de8 42292-006 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine TABLET ORAL 20150731 ANDA ANDA079225 Mylan Institutional Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 42292-007_9410215d-828c-454c-a44e-ad0fb0c65f68 42292-007 HUMAN PRESCRIPTION DRUG Bexarotene Bexarotene CAPSULE, LIQUID FILLED ORAL 20160415 ANDA ANDA203174 Mylan Institutional Inc. BEXAROTENE 75 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 42292-008_7d39e73e-5088-4e92-8dad-72db613d478b 42292-008 HUMAN PRESCRIPTION DRUG Linezolid linezolid TABLET, FILM COATED ORAL 20160122 ANDA ANDA078845 Mylan Institutional Inc. LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 42292-009_60152f4a-c1d9-7eb1-e053-2a91aa0a7846 42292-009 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE PELLETS ORAL 20160601 ANDA ANDA078936 Mylan Institutional Inc. ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 42292-010_60152f4a-c1d9-7eb1-e053-2a91aa0a7846 42292-010 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE PELLETS ORAL 20160531 ANDA ANDA078936 Mylan Institutional Inc. ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 42292-011_5b33322a-d162-0bdc-e053-2a91aa0aeaec 42292-011 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ENTERAL 20160328 ANDA ANDA040274 Mylan Institutional Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 42292-012_61f34841-e1c2-42f6-b428-649995415a62 42292-012 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20160510 ANDA ANDA202050 Mylan Institutional Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 42292-013_61f34841-e1c2-42f6-b428-649995415a62 42292-013 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20160426 ANDA ANDA202050 Mylan Institutional Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 42292-014_61f34841-e1c2-42f6-b428-649995415a62 42292-014 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20160427 ANDA ANDA202050 Mylan Institutional Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 42292-015_61f34841-e1c2-42f6-b428-649995415a62 42292-015 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20160427 ANDA ANDA202050 Mylan Institutional Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 42292-016_61f34841-e1c2-42f6-b428-649995415a62 42292-016 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20160428 ANDA ANDA202050 Mylan Institutional Inc. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 42292-017_50222df4-5c41-1304-e054-00144ff88e88 42292-017 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide spironolactone and hydrochlorothiazide TABLET ORAL 20170512 ANDA ANDA086513 Mylan Institutional Inc. SPIRONOLACTONE; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 42292-018_feae56cb-6eda-4f5d-acb0-fe252a81d295 42292-018 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20160922 ANDA ANDA065442 Mylan Institutional Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 42292-019_43c9f6b6-7ff4-1e85-e054-00144ff88e88 42292-019 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20161208 ANDA ANDA090778 Mylan Institutional Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42292-020_43c9f6b6-7ff4-1e85-e054-00144ff88e88 42292-020 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20161213 ANDA ANDA090778 Mylan Institutional Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42292-021_43c9f6b6-7ff4-1e85-e054-00144ff88e88 42292-021 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20161209 ANDA ANDA090778 Mylan Institutional Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42292-024_3b7813be-3e73-0c48-e054-00144ff8d46c 42292-024 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20160823 ANDA ANDA200651 Mylan Institutional GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 42292-025_3b7813be-3e73-0c48-e054-00144ff8d46c 42292-025 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20160822 ANDA ANDA200651 Mylan Institutional GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 42292-026_5bed7cb1-1ea7-202e-e053-2a91aa0a9886 42292-026 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160920 ANDA ANDA203802 Mylan Institutional Inc. PALIPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 42292-027_5bed7cb1-1ea7-202e-e053-2a91aa0a9886 42292-027 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160915 ANDA ANDA203802 Mylan Institutional Inc. PALIPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] N 20181231 42292-028_3b7813be-3eaa-0c48-e054-00144ff8d46c 42292-028 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20160824 ANDA ANDA090624 Mylan Institutional Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 42292-029_3ad40b56-2edf-6173-e054-00144ff88e88 42292-029 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET, FILM COATED ORAL 20160815 ANDA ANDA079161 Mylan Institutional Inc. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42292-030_3ad40b56-2edf-6173-e054-00144ff88e88 42292-030 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET, FILM COATED ORAL 20160815 ANDA ANDA079161 Mylan Institutional Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42292-031_3ad40b56-2edf-6173-e054-00144ff88e88 42292-031 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET, FILM COATED ORAL 20160816 ANDA ANDA079161 Mylan Institutional Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42292-032_3ad40b56-2edf-6173-e054-00144ff88e88 42292-032 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET, FILM COATED ORAL 20160816 ANDA ANDA079161 Mylan Institutional Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42292-036_5de0dff6-1dfa-3deb-e053-2991aa0a5ec4 42292-036 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20161110 ANDA ANDA078276 Mylan Institutional Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42292-037_5de0dff6-1dfa-3deb-e053-2991aa0a5ec4 42292-037 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20161110 ANDA ANDA078276 Mylan Institutional Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42292-038_47051e05-4041-11cd-e054-00144ff8d46c 42292-038 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20170118 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 42292-039_47051e05-4041-11cd-e054-00144ff8d46c 42292-039 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20170119 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 42292-040_47051e05-4041-11cd-e054-00144ff8d46c 42292-040 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20170119 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 42292-043_5e07fdda-88a8-1b33-e053-2a91aa0a99a5 42292-043 HUMAN PRESCRIPTION DRUG Imatinib Mesylate imatinib TABLET, FILM COATED ORAL 20171116 ANDA ANDA204644 Mylan Institutional Inc. IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 42292-044_5e07fdda-88a8-1b33-e053-2a91aa0a99a5 42292-044 HUMAN PRESCRIPTION DRUG Imatinib Mesylate imatinib TABLET, FILM COATED ORAL 20171116 ANDA ANDA204644 Mylan Institutional Inc. IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 42302-010_c117d526-ac65-4322-a24e-1634860a7142 42302-010 HUMAN OTC DRUG Antibacterial Hand - Aloe Vera TRICLOSAN SOAP TOPICAL 20120125 OTC MONOGRAPH FINAL part333E Lonkey Overseas Inc. TRICLOSAN .15 mL/100mL E 20171231 42302-011_01d771d9-d830-4c20-b4c9-3cf42f17381c 42302-011 HUMAN OTC DRUG Antibacterial Hand -Vanilla Brown Sugar TRICLOSAN SOAP TOPICAL 20120125 OTC MONOGRAPH FINAL part333E Lonkey Overseas Inc. TRICLOSAN .15 mL/100mL E 20171231 42302-030_a3b907bc-37cb-497f-ba87-51680230ecc7 42302-030 HUMAN OTC DRUG Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120125 OTC MONOGRAPH FINAL part333E Lonkey Overseas Inc. ALCOHOL 62 mL/100mL E 20171231 42315-002_cff5765a-8c6e-4d5b-97c8-40f5df9bf8f6 42315-002 HUMAN OTC DRUG Eshu Skin Assist SPF 30 Moisturising Sunscreen Homosalate, Octisalate, Avobenzone, Octocrylene LOTION TOPICAL 20110401 OTC MONOGRAPH FINAL part352 Eshu Pty. Ltd. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 8; 4; 3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 42315-672_76f453cb-70e0-4b82-ae7f-773d45197ed1 42315-672 HUMAN OTC DRUG moisturising sunscreen SPF 30 Homosalate, Octisalate, Octinoxate, Octocrylene CREAM TOPICAL 20110217 OTC MONOGRAPH NOT FINAL part352 Eshu Pty Ltd HOMOSALATE; OCTISALATE; OCTINOXATE 8; 4; 3 mL/100mL; mL/100mL; mL/100mL E 20171231 42326-550_60e2d54d-9894-b815-e053-2a91aa0a2ed1 42326-550 HUMAN OTC DRUG Athleticare Anti-Bacterial Hand AC 550 TRICLOSAN GEL TOPICAL 20160305 OTC MONOGRAPH NOT FINAL part333E Petra Hygienic Systems Int Ltd TRICLOSAN 2.5 mg/mL N 20181231 42326-575_60e2d54d-989f-b815-e053-2a91aa0a2ed1 42326-575 HUMAN OTC DRUG Athleticare No-Rinse Hand Sanitizing AC 575 ETHYL ALCOHOL GEL TOPICAL 20160305 OTC MONOGRAPH NOT FINAL part333E Petra Hygienic Systems Int Ltd ALCOHOL 700 mg/mL N 20181231 42326-585_60e2d54d-98ab-b815-e053-2a91aa0a2ed1 42326-585 HUMAN OTC DRUG Athleticare Alcohol-Free Foaming Hand Sanitizer AC 585-F BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160305 OTC MONOGRAPH NOT FINAL part333E Petra Hygienic Systems Int Ltd BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 42333-100_2b62494d-2094-48f5-b4e0-9e7b5232afa5 42333-100 HUMAN OTC DRUG Borasol Eucalyptol, Thymol, Methyl Salicylate, Menthol POWDER TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part356 Laboratorios Dr. Collado, C x A. EUCALYPTOL; THYMOL; METHYL SALICYLATE; MENTHOL .091; .063; .055; .01 g/100g; g/100g; g/100g; g/100g E 20171231 42333-101_9041014f-b4b0-4fa4-b7fb-7a5085bd9f85 42333-101 HUMAN OTC DRUG Bay Rum Constanza Isopropyl Alcohol LIQUID TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A Laboratorios Dr. Collado, C x A. ISOPROPYL ALCOHOL 30 mg/30mL E 20171231 42333-120_61094a33-a770-5719-e053-2991aa0a131c 42333-120 HUMAN OTC DRUG Sancochito Compuesto GUAIFENESIN SYRUP ORAL 20170523 OTC MONOGRAPH FINAL part341 Laboratorios Dr. Collado, S.A. GUAIFENESIN 100 mg/5mL N 20181231 42338-001_2db50852-0050-42e6-9057-419ed56f4b88 42338-001 HUMAN OTC DRUG EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120106 OTC MONOGRAPH FINAL part352 Extrashade a Sub of Versitile Group AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 42339-001_5f6707a3-86a2-ab9e-e053-2a91aa0a16d5 42339-001 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20120218 OTC MONOGRAPH FINAL part344 Shandong Haiyan Medical Manufacture Co., Ltd. ISOPROPYL ALCOHOL .7 mL/1 N 20181231 42339-002_648cc00b-69b9-45d9-8933-e0d0892de476 42339-002 HUMAN OTC DRUG Povidone-Iodine Pad Povidone-Iodine SWAB TOPICAL 20120218 OTC MONOGRAPH FINAL part333C Shandong Haiyan Medical Manufacture Co., Ltd. POVIDONE-IODINE 9.43 g/100g N 20181231 42346-100_0ed91856-1390-4933-8827-a1acfa15b6a8 42346-100 HUMAN OTC DRUG Frankincense and Myrrh Cold and Flu Prevention Eucalyptus Globulus, Myrrha, Olibanum, Romarinus Officinalis OIL TOPICAL 20091106 UNAPPROVED HOMEOPATHIC Wise Consumer Products EUCALYPTUS GLOBULUS LEAF; MYRRH; FRANKINCENSE; ROSEMARY 2; 2; 2; 2 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 42346-200_65b4c19a-08f0-40e0-b1ff-b33dfc8ef24c 42346-200 HUMAN OTC DRUG Frankincense and Myrrh Sinus Eucalyptus Globulus, Geranium Maculatum, Myrrha, Olibanum (Frankincense), Romarinus Officinalis OIL TOPICAL 20091106 UNAPPROVED HOMEOPATHIC Wise Consumer Products EUCALYPTUS GLOBULUS LEAF; MYRRH; FRANKINCENSE; ROSMARINUS OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT 2; 2; 2; 2; 2 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 42346-301_3c2bcec9-53c9-4c8c-a31c-1dcef7acce76 42346-301 HUMAN OTC DRUG Frankincense and Myrrh Neuropathy Aconitum Napellus, Bryonia Alba, Hypericum Perforatum OIL TOPICAL 20130611 UNAPPROVED HOMEOPATHIC Wise Consumer Products ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM 3; 3; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 42346-400_32728e05-7e3f-4926-a853-746c79cac744 42346-400 HUMAN OTC DRUG Frankincense and Myrrh Fibromyalgia Aconitum Napellus, Bryonia Alba, Geranium Maculatum, Hypericum OIL TOPICAL 20091201 UNAPPROVED HOMEOPATHIC Wise Consumer Products ACONITUM NAPELLUS; BRYONIA ALBA ROOT; GERANIUM MACULATUM ROOT; ST. JOHN'S WORT 3; 2; 2; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 42346-500_053f478e-4b46-4e5c-95c7-89fcb2339e04 42346-500 HUMAN OTC DRUG Frankincense and Myrrh Sciatica Aconitum napellus, Bryonia alba, Hypericum perforatum OIL TOPICAL 20130402 UNAPPROVED HOMEOPATHIC Wise Consumer Products Co. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM 3; 3; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 42346-501_4d471d7e-f710-48c8-858d-aeae59a5cabb 42346-501 HUMAN OTC DRUG Frankincense and Myrrh Sciatica Aconitum napellus, Bryonia alba, Hypericum perforatum OIL TOPICAL 20170601 UNAPPROVED HOMEOPATHIC Wise Consumer Products Co. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM 3; 3; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 42346-600_2016927e-7dad-4bc6-a75e-7878faefcbc9 42346-600 HUMAN OTC DRUG Frankincense and Myrrh Carpal Tunnel Aconitum napellus, Bryonia alba, Hypericum perforatum OIL TOPICAL 20130402 UNAPPROVED HOMEOPATHIC Wise Consumer Products ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM 3; 3; 3 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL N 20181231 42346-601_364152ce-817c-49b9-b267-64039f2dc076 42346-601 HUMAN OTC DRUG Frankincense and Myrrh Carpal Tunnel Aconitum napellus, Bryonia alba, Hypericum perforatum OIL TOPICAL 20170601 UNAPPROVED HOMEOPATHIC Wise Consumer Products ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM 3; 3; 3 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL N 20181231 42346-700_6e998214-b059-408b-895c-00876d3aeb3f 42346-700 HUMAN OTC DRUG Frankincense and Myrrh Neck Shoulder and Knee Aconitum napellus, Bryonia alba, Hypericum perforatum OIL TOPICAL 20130402 UNAPPROVED HOMEOPATHIC Wise Consumer Products Co. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM 3; 3; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 42346-701_7a3ff229-a7eb-4f03-9a80-7717e40f8f7f 42346-701 HUMAN OTC DRUG Frankincense and Myrrh Neck Shoulder and Knee Aconitum napellus, Bryonia alba, Hypericum perforatum OIL TOPICAL 20170601 UNAPPROVED HOMEOPATHIC Wise Consumer Products Co. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM 3; 3; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 42352-1001_661500e3-6f71-48aa-b7c5-fcc13c8a2bdb 42352-1001 HUMAN OTC DRUG Solmeet Denti doctor Rosin POWDER, DENTIFRICE DENTAL 20101211 UNAPPROVED DRUG OTHER Solbin Co., Ltd ROSIN .332 g/g E 20171231 42352-2001_d7b41c14-85d9-46b8-aca5-1db9f6e97486 42352-2001 HUMAN OTC DRUG Solmeet denti doctor calcium carbonate PASTE, DENTIFRICE DENTAL 20101215 UNAPPROVED DRUG OTHER Solbin Co., Ltd CALCIUM CARBONATE; DIBASIC CALCIUM PHOSPHATE DIHYDRATE; AMINOCAPROIC ACID; ALCLOXA 15.85; .6; .05; .05 g/100g; g/100g; g/100g; g/100g E 20171231 42352-3001_21e10174-1084-489a-ab25-028423e10ae4 42352-3001 HUMAN OTC DRUG Solmeet calcium carbonate PASTE, DENTIFRICE DENTAL 20101215 UNAPPROVED DRUG OTHER Solbin Co., Ltd CALCIUM CARBONATE; DIBASIC CALCIUM PHOSPHATE DIHYDRATE; AMINOCAPROIC ACID; ALCLOXA 15.85; .6; .05; .05 g/100g; g/100g; g/100g; g/100g E 20171231 42352-7001_c0412d16-9431-41bd-88af-25623de1e551 42352-7001 HUMAN OTC DRUG Solmeet calcium carbonate PASTE, DENTIFRICE DENTAL 20101215 UNAPPROVED DRUG OTHER Solbin Co., Ltd CALCIUM CARBONATE; DIBASIC CALCIUM PHOSPHATE DIHYDRATE; AMINOCAPROIC ACID; ALCLOXA 15.85; .6; .05; .05 g/100g; g/100g; g/100g; g/100g E 20171231 42352-8001_c51c4c2a-54e2-4b21-8a00-81dc63d15bca 42352-8001 HUMAN OTC DRUG Solmeet denti doctor calcium carbonate PASTE, DENTIFRICE DENTAL 20101215 UNAPPROVED DRUG OTHER Solbin Co., Ltd CALCIUM CARBONATE; DIBASIC CALCIUM PHOSPHATE DIHYDRATE; AMINOCAPROIC ACID; ALCLOXA 15.85; .6; .05; .05 g/100g; g/100g; g/100g; g/100g E 20171231 42354-7482_d621b997-3f9f-40b4-a259-788fc0cfe38e 42354-7482 HUMAN OTC DRUG American Red Cross First Aid Kit ALCOHOL, BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ALCOHOL KIT 20120117 OTC MONOGRAPH NOT FINAL part333A Tomy International E 20171231 42355-265_60d359e3-d062-4f78-872d-4e218e93a40d 42355-265 HUMAN OTC DRUG All Stop Medicated Body Wash BENZALKONIUM CHLORIDE SOAP TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part333E Q-Based Solutions Inc BENZALKONIUM CHLORIDE 25 mg/mL N 20181231 42357-001_7a1634c5-6e0f-4ed0-adca-467963541107 42357-001 HUMAN OTC DRUG MyntSmile DIAMYNT SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20120310 OTC MONOGRAPH FINAL part355 LMKAO LLC SODIUM MONOFLUOROPHOSPHATE .83 g/100g N 20181231 42358-100_463c068d-9e51-43c7-8d01-116947effb42 42358-100 HUMAN PRESCRIPTION DRUG Abstral fentanyl fentanyl citrate TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20161001 NDA NDA022510 Sentynl Therapeutics, Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42358-102_03348c87-a2e7-41cf-beeb-34e684ceb3c6 42358-102 HUMAN PRESCRIPTION DRUG Levorphanol Tartrate Levorphanol Tartrate TABLET ORAL 20000331 ANDA ANDA074278 Sentynl Therapeutics, Inc. LEVORPHANOL TARTRATE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42358-200_463c068d-9e51-43c7-8d01-116947effb42 42358-200 HUMAN PRESCRIPTION DRUG Abstral fentanyl fentanyl citrate TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20161001 NDA NDA022510 Sentynl Therapeutics, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42358-300_463c068d-9e51-43c7-8d01-116947effb42 42358-300 HUMAN PRESCRIPTION DRUG Abstral fentanyl fentanyl citrate TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20161001 NDA NDA022510 Sentynl Therapeutics, Inc. FENTANYL CITRATE 300 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42358-400_463c068d-9e51-43c7-8d01-116947effb42 42358-400 HUMAN PRESCRIPTION DRUG Abstral fentanyl fentanyl citrate TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20161001 NDA NDA022510 Sentynl Therapeutics, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42358-600_463c068d-9e51-43c7-8d01-116947effb42 42358-600 HUMAN PRESCRIPTION DRUG Abstral fentanyl fentanyl citrate TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20161001 NDA NDA022510 Sentynl Therapeutics, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42358-800_463c068d-9e51-43c7-8d01-116947effb42 42358-800 HUMAN PRESCRIPTION DRUG Abstral fentanyl fentanyl citrate TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20161001 NDA NDA022510 Sentynl Therapeutics, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42361-043_60e263af-08c9-87b1-e053-2991aa0a0f60 42361-043 HUMAN OTC DRUG YouGreen F Urea OINTMENT TOPICAL 20171221 20181231 UNAPPROVED DRUG OTHER Dong Sung Bio Pharm. Co., Ltd. UREA 7.5 g/30g N 20181231 42361-061_60ab4bbf-4985-99f8-e053-2a91aa0a83db 42361-061 HUMAN OTC DRUG DS Never Cold S Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20171218 OTC MONOGRAPH NOT FINAL part343 Dong Sung Bio Pharm. Co., Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 42361-101_60e15337-c582-500e-e053-2991aa0abed0 42361-101 HUMAN OTC DRUG Impact Fix Essence Make Up Base SPF 10 / UVB Protection Octinoxate, Titanium Dioxide CREAM TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part352 Dong Sung Bio Pharm. Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE 30; 20 mg/g; mg/g N 20181231 42361-123_60e15cc6-553e-3091-e053-2a91aa0a8d74 42361-123 HUMAN OTC DRUG Impact Fix Prism Two Way Cake Broad Spectrum SPF 24 Octinoxate, Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part352 Dong Sung Bio Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 14; 68; 39 mg/g; mg/g; mg/g N 20181231 42361-133_60e15337-c58d-500e-e053-2991aa0abed0 42361-133 HUMAN OTC DRUG Impact Fix Prism Two Way Cake Broad Spectrum SPF 24 Octinoxate, Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part352 Dong Sung Bio Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 14; 68; 39 mg/g; mg/g; mg/g N 20181231 42361-135_60e155b4-abbf-4683-e053-2a91aa0aa5be 42361-135 HUMAN OTC DRUG Impact Fix Pure Essence Foundation Broad Spectrum SPF 20 Octinoxate, Titanium Dioxide CREAM TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part352 Dong Sung Bio Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE 20; 99.9 mg/g; mg/g N 20181231 42361-151_60ab4bbf-4999-99f8-e053-2a91aa0a83db 42361-151 HUMAN OTC DRUG ac care Bees Shield BB Broad Spectrum SPF 35 Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Dong Sung Bio Pharm. Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 44.1; 19.6; 70 mg/g; mg/g; mg/g N 20181231 42361-152_60ab39c1-f84e-1c7b-e053-2991aa0a68a8 42361-152 HUMAN OTC DRUG ac care Bees Sun Protection Broad Spectrum SPF 50 Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170116 OTC MONOGRAPH NOT FINAL part352 Dong Sung Bio Pharm. Co., Ltd. ENSULIZOLE; TITANIUM DIOXIDE; ZINC OXIDE; OCTOCRYLENE; OCTINOXATE 39; 49; 49; 30; 74 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 42361-202_60ab4bbf-4998-99f8-e053-2a91aa0a83db 42361-202 HUMAN OTC DRUG Re20 Ultra Sun Defense Special Set Broad Spectrum SPF 44 Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part352 Dong Sung Bio Pharm. Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 24; 29 mg/g; mg/g; mg/g N 20181231 42361-203_60aab852-26ce-7a08-e053-2991aa0a469c 42361-203 HUMAN OTC DRUG Re20 Advanced Wrinkle Control BB Cream Broad Spectrum SPF 50 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20171218 OTC MONOGRAPH NOT FINAL part352 Dong Sung Bio Pharm. Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 99; 63 mg/g; mg/g N 20181231 42364-0003_8ae5e4d7-1e73-01f6-87c6-9b43ac686778 42364-0003 HUMAN OTC DRUG Anti Monkey Butt Diaper Rash Zinc Oxide and Ferric Oxide Red CREAM TOPICAL 20120418 OTC MONOGRAPH FINAL part352 DSE Healthcare Solutions, LLC. ZINC OXIDE; FERRIC OXIDE RED .139; .001 g/g; g/g N 20181231 42364-0013_a52cbea7-84bb-908a-1c14-1b1a88004f58 42364-0013 HUMAN OTC DRUG Baby Anti Monkey Butt Diaper Rash Ferric Oxide Red and Zinc Oxide POWDER TOPICAL 20120418 OTC MONOGRAPH FINAL part352 DSE Healthcare Solutions, LLC. ZINC OXIDE; FERRIC OXIDE RED .076; .004 g/g; g/g N 20181231 42364-4501_be9671af-3614-d70e-8639-87f8dc8e3b44 42364-4501 HUMAN OTC DRUG Cystex Plus Methenamine, Sodium Salicylate TABLET ORAL 20120401 UNAPPROVED DRUG OTHER DSE Healthcare Solutions, LLC METHENAMINE; SODIUM SALICYLATE 162; 162.5 mg/1; mg/1 N 20181231 42367-110_a9cea5dd-d282-4ba2-ac44-d8b01eceffb1 42367-110 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Delayed-Release Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20140715 ANDA ANDA200540 Eagle Pharmaceuticals, Inc. DICLOFENAC SODIUM; MISOPROSTOL 50; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 42367-111_a9cea5dd-d282-4ba2-ac44-d8b01eceffb1 42367-111 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Delayed-Release Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20140715 ANDA ANDA200540 Eagle Pharmaceuticals, Inc. DICLOFENAC SODIUM; MISOPROSTOL 75; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 42367-121_8af6f0cc-7684-4f61-9a8e-dcca893c40ad 42367-121 HUMAN PRESCRIPTION DRUG Docetaxel Non-Alcohol Formula docetaxel INJECTION INTRAVENOUS 20160115 NDA NDA205934 Eagle Pharmaceuticals, Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 42367-202_cff8b8b0-c05e-4250-b123-eec4e8654003 42367-202 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20110906 NDA NDA022434 Eagle Pharmaceuticals, Inc. ARGATROBAN 1 mg/mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 42367-203_86b223f9-5403-4ebd-a14e-178e1aa11cc3 42367-203 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION INTRAVENOUS 20110906 NDA NDA022434 Eagle Pharmaceuticals, Inc. ARGATROBAN 1 mg/mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 42367-540_7a1f03a5-5ff4-421a-afbb-4d8577a26944 42367-540 HUMAN PRESCRIPTION DRUG RYANODEX dantrolene sodium dantrolene sodium INJECTION, SUSPENSION INTRAVENOUS 20140723 NDA NDA205579 Eagle Pharmaceuticals, Inc. DANTROLENE SODIUM 250 mg/5mL Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 42377-001_5a71fe24-8b62-4052-a994-fb7bf9f91e2c 42377-001 HUMAN OTC DRUG Next 1 Anti-Bacterial Sport TRICLOCARBAN SOAP TOPICAL 20130606 OTC MONOGRAPH NOT FINAL part333E HADA International S.A TRICLOCARBAN 1.5 g/100g E 20171231 42387-001_be2d3046-d640-4da9-9cba-2df7d4b7f0e8 42387-001 HUMAN OTC DRUG SunClear zinc oxide CREAM TOPICAL 20150901 OTC MONOGRAPH FINAL part347 Grahams Natural Alternatives Pty Ltd ZINC OXIDE 25 g/100g E 20171231 42387-123_9115b517-7163-4b7a-b471-94890e82ec4c 42387-123 HUMAN OTC DRUG GN Kids Eczema Oatmeal CREAM TOPICAL 20120424 OTC MONOGRAPH FINAL part347 Grahams Natural Alternatives Pty Ltd OATMEAL 25 mg/g E 20171231 42387-135_382b84d8-6c03-24ca-e054-00144ff88e88 42387-135 HUMAN OTC DRUG Grahams Natural Diaper Rash Zinc Oxide CREAM TOPICAL 20160721 OTC MONOGRAPH FINAL part347 Grahams Natural Alternatives Pty Ltd ZINC OXIDE 12 g/100g E 20171231 42387-200_a702b975-90f2-4224-8030-5a425388cd44 42387-200 HUMAN OTC DRUG Grahams Natural Psoriasis and Dermatitis salicylic acid CREAM TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Grahams Natural Alternatives Pty Ltd SALICYLIC ACID 2 g/100g E 20171231 42387-300_c1e9b13d-27c7-4fc5-9a0a-7cf14ee8f81c 42387-300 HUMAN OTC DRUG Grahams Natural Eczema Gel allantoin GEL TOPICAL 20150826 OTC MONOGRAPH FINAL part347 Grahams Natural Alternatives Pty Ltd ALLANTOIN .8 g/100g E 20171231 42388-011_8140119f-e22e-41ef-b6d9-107c4881ffcb 42388-011 HUMAN PRESCRIPTION DRUG COMETRIQ cabozantinib KIT 20121129 NDA NDA203756 Exelixis, Inc. N 20191231 42388-012_8140119f-e22e-41ef-b6d9-107c4881ffcb 42388-012 HUMAN PRESCRIPTION DRUG COMETRIQ cabozantinib KIT 20121129 NDA NDA203756 Exelixis, Inc. N 20191231 42388-013_8140119f-e22e-41ef-b6d9-107c4881ffcb 42388-013 HUMAN PRESCRIPTION DRUG COMETRIQ cabozantinib CAPSULE ORAL 20121129 NDA NDA203756 Exelixis, Inc. CABOZANTINIB S-MALATE 20 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 42388-023_6e822a08-5696-432d-bb8c-a53a0ceaaefa 42388-023 HUMAN PRESCRIPTION DRUG CABOMETYX cabozantinib TABLET ORAL 20160425 NDA NDA208692 Exelixis, Inc. CABOZANTINIB S-MALATE 60 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] E 20171231 42388-024_6e822a08-5696-432d-bb8c-a53a0ceaaefa 42388-024 HUMAN PRESCRIPTION DRUG CABOMETYX cabozantinib TABLET ORAL 20160425 NDA NDA208692 Exelixis, Inc. CABOZANTINIB S-MALATE 20 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] E 20171231 42388-025_6e822a08-5696-432d-bb8c-a53a0ceaaefa 42388-025 HUMAN PRESCRIPTION DRUG CABOMETYX cabozantinib TABLET ORAL 20160425 NDA NDA208692 Exelixis, Inc. CABOZANTINIB S-MALATE 40 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] E 20171231 42389-001_0041a2bf-1cf4-4058-9f39-146adad23351 42389-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20071201 NDA NDA205840 Carepro Health Risk Management OXYGEN 990 mL/L N 20181231 42392-001_ad98495f-250c-4926-9c35-8ac88c7d2686 42392-001 HUMAN PRESCRIPTION DRUG Nitrogen, Refrigerated NITROGEN LIQUID RESPIRATORY (INHALATION) 20120201 UNAPPROVED MEDICAL GAS Schwarcz Liquid Nitrogen Service, Inc. NITROGEN 1 L/L E 20171231 42406-002_615a5cc8-a0d4-068a-e053-2991aa0a274c 42406-002 HUMAN OTC DRUG Fresh Sugar Coral Tinted Lip Treatment SPF 15 OCTINOXATE, AVOBENZONE STICK TOPICAL 20120208 OTC MONOGRAPH FINAL part352 Fresh, Inc. OCTINOXATE; AVOBENZONE 7.49; 2 g/100g; g/100g N 20181231 42406-003_615a62de-7845-0a4f-e053-2a91aa0a9884 42406-003 HUMAN OTC DRUG Fresh Sugar Berry Tinted Lip Treatment SPF 15 AVOBENZONE, OCTINOXATE STICK TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE 2; 7.49 g/100g; g/100g N 20181231 42406-004_615a9517-e137-5e34-e053-2991aa0a417e 42406-004 HUMAN OTC DRUG Fresh Sugar Petal Tinted Lip Treatment SPF 15 AVOBENZONE, OCTINOXATE STICK TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE 2; 7.49 g/100g; g/100g N 20181231 42406-006_cad95775-3d92-4438-871e-7d18d0278b9b 42406-006 HUMAN OTC DRUG Fresh Sugar Tulip Tinted Lip Treatment Sunscreen SPF 15 AVOBENZONE, OCTINOXATE STICK TOPICAL 20140109 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE 2; 7.49 g/100g; g/100g N 20181231 42406-007_615ac2dd-ea62-8329-e053-2a91aa0a6927 42406-007 HUMAN OTC DRUG Fresh Peony Brightening UV Shield Sunscreen SPF 50 Plus OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20140109 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 74.9; 20; 88.8 mg/mL; mg/mL; mg/mL N 20181231 42406-008_e36b75c9-ceba-4eac-b387-1382025d1e9d 42406-008 HUMAN OTC DRUG Fresh Sugar Ruby Tinted Lip Treatment Sunscreen SPF 15 AVOBENZONE, OCTINOXATE STICK TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE 20; 7.49 g/100g; g/100g N 20181231 42406-009_a8258de1-c231-494f-89d2-d515c3f15358 42406-009 HUMAN OTC DRUG Fresh Black Tea Age-Delay Broad Spectrum Sunscreen SPF 20 AVOBENZONE, OCTINOXATE, OXYBENZONE LOTION TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 18; 74.9; 24 mg/mL; mg/mL; mg/mL N 20181231 42406-011_69b319b4-37ca-46c7-88e6-7925f4dcc92a 42406-011 HUMAN OTC DRUG Sugar Nude Tinted Lip Treatment Sunscreen SPF 15 AVOBENZONE, OCTINOXATE PASTE TOPICAL 20150306 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE .02; .0749 g/g; g/g N 20181231 42406-012_615ac2dd-ea72-8329-e053-2a91aa0a6927 42406-012 HUMAN OTC DRUG Sugar Fig Tinted Lip Treatment Sunscreen SPF 15 AVOBENZONE, OCTINOXATE PASTE TOPICAL 20150307 OTC MONOGRAPH NOT FINAL part352 Fresh, Inc. AVOBENZONE; OCTINOXATE .02; .0749 g/g; g/g N 20181231 42406-013_615a9517-e16c-5e34-e053-2991aa0a417e 42406-013 HUMAN OTC DRUG Fresh Sugar Rose Tinted Lip Treatment SPF 15 OCTINOXATE, OXYBENZONE PASTE TOPICAL 20150918 OTC MONOGRAPH NOT FINAL part352 Fresh Inc. OCTINOXATE; OXYBENZONE 7.49; 2 g/100g; g/100g N 20181231 42406-014_615ac2dd-ea83-8329-e053-2a91aa0a6927 42406-014 HUMAN OTC DRUG Fresh Sugar Roll-on Deodorant ALUMINUM CHLOROHYDRATE EMULSION TOPICAL 20150918 OTC MONOGRAPH FINAL part350 Fresh Inc. ALUMINUM CHLOROHYDRATE 150 mg/mL N 20181231 42406-016_615ac2dd-69e2-3275-e053-2991aa0a544d 42406-016 HUMAN OTC DRUG Fresh Sugar Lip Treatment SPF 15 OCTINOXATE, OXYBENZONE PASTE TOPICAL 20150917 OTC MONOGRAPH NOT FINAL part352 Fresh Inc. OCTINOXATE; OXYBENZONE 7.49; 2 g/100g; g/100g N 20181231 42406-017_615ac2dd-ea90-8329-e053-2a91aa0a6927 42406-017 HUMAN OTC DRUG Fresh Sugar Honey Tinted Lip Treatment SPF 15 AVOBENZONE, OCTINOXATE PASTE TOPICAL 20150917 OTC MONOGRAPH NOT FINAL part352 Fresh Inc. AVOBENZONE; OCTINOXATE 2; 7.49 g/100g; g/100g N 20181231 42406-019_615ac2dd-69f1-3275-e053-2991aa0a544d 42406-019 HUMAN OTC DRUG Sugar Bloom Lip Treatment Sunscreen SPF 15 AVOBENZONE, OCTINOXATE PASTE TOPICAL 20160713 OTC MONOGRAPH NOT FINAL part352 Fresh Inc. AVOBENZONE; OCTINOXATE 20; 74.9 mg/g; mg/g N 20181231 42406-020_615aebac-577a-c718-e053-2a91aa0a56a3 42406-020 HUMAN OTC DRUG SUGAR CANDY LIP TREATMENT SUNSCREEN SPF 15 Octinoxate, Oxybenzone PASTE TOPICAL 20160823 OTC MONOGRAPH NOT FINAL part352 Fresh Inc. OCTINOXATE; OXYBENZONE 74.9; 20 g/100g; g/100g N 20181231 42406-021_615ae6ca-d811-bdc6-e053-2a91aa0a70df 42406-021 HUMAN OTC DRUG SUGAR POPPY LIP TREATMENT SUNSCREEN SPF 15 AVOBENZONE, OCTINOXATE PASTE TOPICAL 20161027 OTC MONOGRAPH NOT FINAL part352 Fresh Inc. AVOBENZONE; OCTINOXATE 20; 74.9 mg/g; mg/g N 20181231 42406-022_615ae6ca-d822-bdc6-e053-2a91aa0a70df 42406-022 HUMAN OTC DRUG SUGAR SPORT TREATMENT SUNSCREEN SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE PASTE TOPICAL 20161027 OTC MONOGRAPH NOT FINAL part352 Fresh Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 20; 74.9; 30 mg/g; mg/g; mg/g N 20181231 42406-030_615ae6ca-d836-bdc6-e053-2a91aa0a70df 42406-030 HUMAN OTC DRUG SUGAR SPICE LIP TREATMENT SUNSCREEN SPF 15 OCTINOXATE PASTE TOPICAL 20170805 OTC MONOGRAPH NOT FINAL part352 Fresh Inc OCTINOXATE 67.4 mg/g N 20181231 42406-031_615ae6ca-d847-bdc6-e053-2a91aa0a70df 42406-031 HUMAN OTC DRUG SUGAR PUNCH LIP TREATMENT SUNSCREEN SPF 15 OCTINOXATE PASTE TOPICAL 20170808 OTC MONOGRAPH NOT FINAL part352 Fresh Inc AVOBENZONE; OCTINOXATE 20; 74.9 mg/g; mg/g N 20181231 42406-032_5d571284-2228-6466-e053-2a91aa0aa9ef 42406-032 HUMAN OTC DRUG SUGAR LIP TREATMENT SUNSCREEN SPF 15 AVOBENZONE, OCTINOXATE PASTE TOPICAL 20171106 OTC MONOGRAPH NOT FINAL part352 Fresh Inc AVOBENZONE; OCTINOXATE 20; 74.9 mg/g; mg/g N 20181231 42406-033_5d571284-2238-6466-e053-2a91aa0aa9ef 42406-033 HUMAN OTC DRUG SUGAR ROSE LIP TREATMENT SUNSCREEN SPF 15 AVOBENZONE, OCTINOXATE PASTE TOPICAL 20171106 OTC MONOGRAPH NOT FINAL part352 Fresh Inc AVOBENZONE; OCTINOXATE 20; 74.9 mg/g; mg/g N 20181231 42411-010_a41516d7-1490-46c5-82bc-297c21388258 42411-010 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Air Liquide America Specialty Gases LLC OXYGEN 99 L/100L E 20171231 42416-0021_3bd6abd3-df25-4022-ad4e-a610b77c897d 42416-0021 HUMAN OTC DRUG Formula 21 Diaper Rash ZINC OXIDE CREAM TOPICAL 20120126 OTC MONOGRAPH FINAL part347 DRA Bello Products, Inc. ZINC OXIDE 25 mL/100mL E 20171231 42421-018_227eb165-5faa-4001-a956-1ece266d2ef7 42421-018 HUMAN OTC DRUG Edge Antiperspirant Deodorant - Glacier Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20180104 OTC MONOGRAPH FINAL part350 Emilia Personal Care Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.47 g/76.5g N 20191231 42421-020_2a6049c0-4907-442b-a24b-8ca7a0f0c129 42421-020 HUMAN OTC DRUG Edge Antiperspirant Deodorant - Active Endurance ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20180104 OTC MONOGRAPH FINAL part350 Emilia Personal Care Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.47 g/76.5g N 20191231 42421-022_87ecf621-d4a3-4c6b-97b0-8a2942fd1f75 42421-022 HUMAN OTC DRUG Edge Antiperspirant Deodorant - Glacier Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20180104 OTC MONOGRAPH FINAL part350 Emilia Personal Care Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.47 g/76.5g N 20191231 42421-034_7d1fb191-0462-411b-8494-48e15637b96a 42421-034 HUMAN OTC DRUG Ultimate Daily Face Wash Salicylic Acid CREAM TOPICAL 20140110 OTC MONOGRAPH FINAL part333D Emilia Personal Care Inc. SALICYLIC ACID 2 g/100mL N 20181231 42421-075_86988867-1c6a-460a-852b-031179055def 42421-075 HUMAN OTC DRUG Safe Harbor Natural Suncare Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20151115 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc TITANIUM DIOXIDE; ZINC OXIDE 8.8; 4.34 g/124g; g/124g N 20181231 42421-076_6a80b5a1-2294-4630-b13a-335642385924 42421-076 HUMAN OTC DRUG Safe Harbor Natural Suncare Natural Face and Neck Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20161230 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc TITANIUM DIOXIDE; ZINC OXIDE 8.8; 4.34 g/124g; g/124g N 20181231 42421-100_6ac119cc-0a5a-4451-9c54-7549e7080ae6 42421-100 HUMAN OTC DRUG emilia Naked Sun AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE GEL TOPICAL 20171206 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.72; 12.4; 6.2; 2.48; 4.96 g/124mL; g/124mL; g/124mL; g/124mL; g/124mL N 20181231 42421-101_8f55a93f-33f3-4f17-aa83-69f015e95cdc 42421-101 HUMAN OTC DRUG emilia Naked Sun Body Gel SPF30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE GEL TOPICAL 20171206 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.72; 12.4; 6.2; 2.48; 4.96 g/124mL; g/124mL; g/124mL; g/124mL; g/124mL N 20191231 42421-102_28781098-bb70-4320-8938-2d838bdbf8eb 42421-102 HUMAN OTC DRUG emilia Naked Sun SPF 50 Invisible Face Gel AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE GEL TOPICAL 20171213 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 5; 2 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL N 20181231 42421-115_263bf96a-ddb9-45cc-8c80-8f69843d55c5 42421-115 HUMAN OTC DRUG H-E-B Dead Sea Organics Protect and Perfect Day Broad Spectrum SPF15 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 42421-192_829897a2-e7e0-446e-86fa-4dc7108132e2 42421-192 HUMAN OTC DRUG Aureli Broad Spectrum AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE GEL TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 42421-200_4cd01ee8-844b-4a71-9aaf-ddb379d74db3 42421-200 HUMAN OTC DRUG emilia SAFE HARBOR NATURAL SUNCARE TITANIUM DIOXIDE, ZINC OXIDE SPRAY TOPICAL 20171207 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc TITANIUM DIOXIDE; ZINC OXIDE 10.92; 11.5 g/150g; g/150g N 20181231 42421-226_730659cc-f4b6-49a0-9459-42652723fd1f 42421-226 HUMAN OTC DRUG Safe Harbor - Natural Anti-Aging Sunscreen Broad Spectrum SPF30 Sunscreen Sensitive Skin Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20140105 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. TITANIUM DIOXIDE; ZINC OXIDE 11.4; 3 g/100mL; g/100mL N 20181231 42421-229_fc2c22fc-39f2-4d23-a5ce-2b169cfb802c 42421-229 HUMAN OTC DRUG Oil Free Blackhead Removal Scrub Salicylic Acid CREAM TOPICAL 20131205 OTC MONOGRAPH FINAL part333D Emilia Personal Care Inc. SALICYLIC ACID 2 g/100g N 20181231 42421-232_80423356-a7ef-4f54-8347-6f7f2c37956f 42421-232 HUMAN OTC DRUG Illuminating Daily Moisturizer Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 g/100mL; g/100mL; g/100mL N 20181231 42421-290_16dbf1bd-60d5-4383-bf31-3905ff9095ef 42421-290 HUMAN OTC DRUG Seacret Active Clear Facial Wash Salicylic Acid GEL TOPICAL 20141017 OTC MONOGRAPH FINAL part333D Emilia Personal Care Inc. SALICYLIC ACID 2 g/100mL N 20181231 42421-326_71f476f9-c532-43a3-847b-a4bd3de519c8 42421-326 HUMAN OTC DRUG Daily Facial Moisturizer Broad Spectrum SPF15 Sunscreen Avobenzone, Octocrylene CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. AVOBENZONE; OCTOCRYLENE 3; 10 g/100mL; g/100mL N 20181231 42421-328_6e16cb91-c2b0-4ec6-8995-9a37475b82f8 42421-328 HUMAN OTC DRUG Aureli Broad Spectrum AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE GEL TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 42421-418_9e2fb9bb-8a79-4675-84df-fd5990f7db1d 42421-418 HUMAN OTC DRUG Safe Harbor - Natural Sunscreen Face and Neck Cream Broad Spectrum SPF40 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140105 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. TITANIUM DIOXIDE; ZINC OXIDE 12.35; 3.5 g/100mL; g/100mL N 20181231 42421-419_fbd287cf-a557-42ab-a530-9aee849c068d 42421-419 HUMAN OTC DRUG Earth and Vine BB Broad Spectrum SPF 15 Sunscreen Octinoxate and Titanium Dioxide CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. OCTINOXATE; TITANIUM DIOXIDE 4; 2.1 g/100g; g/100g N 20181231 42421-428_8479d444-5654-4d5a-b616-bf0a459e5526 42421-428 HUMAN OTC DRUG Aureli Broad Spectrum AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE GEL TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 42421-528_21839d3c-f74e-4a95-95b6-96e3d3a98e4e 42421-528 HUMAN OTC DRUG Aureli Broad Spectrum AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE GEL TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 42421-575_457b8d97-15ee-44eb-a985-b6e69e1ad1d3 42421-575 HUMAN OTC DRUG Safe Harbor Natural Suncare Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20151115 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc TITANIUM DIOXIDE; ZINC OXIDE 9.4; 4.96 g/124g; g/124g N 20181231 42421-576_89f3387d-43fa-412d-af45-78edb219e814 42421-576 HUMAN OTC DRUG Safe Harbor Natural Suncare Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20161230 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc TITANIUM DIOXIDE; ZINC OXIDE 9.4; 4.96 g/124g; g/124g N 20181231 42421-600_8545e35a-514f-41f0-bcd0-519971a4c2cb 42421-600 HUMAN OTC DRUG Fre Broad Spectrum AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20160628 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.8; 4.8; 2.4; 1.2 g/60mL; g/60mL; g/60mL; g/60mL N 20181231 42421-613_862b6c95-4cc6-4581-879e-b3a0dbcb3458 42421-613 HUMAN OTC DRUG Aureli Broad Spectrum AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE GEL TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 42421-618_90d8f83c-012e-42fe-85c5-2e1fe4453f43 42421-618 HUMAN OTC DRUG H-E-B Skin Corrective Innovative Skin Perfector BB Broad Spectrum SPF15 Sunscreen Medium/Deep Titanium Dioxide, Octinoxate CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. TITANIUM DIOXIDE; OCTINOXATE 2.1; 4 g/100mL; g/100mL N 20181231 42421-641_3a3faea7-8862-4d4b-82a0-e86e29f1dc12 42421-641 HUMAN OTC DRUG Innovative Skin Perfector BB Broad Spectrum SPF15 Sunscreen (Light/Medium) Octinoxate and Titanium Dioxide CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. OCTINOXATE; TITANIUM DIOXIDE 4; 2.1 g/100g; g/100g N 20181231 42421-692_d1d1084d-1591-4273-82a1-6b6c23b62a9f 42421-692 HUMAN OTC DRUG Desert Fusion Nutritious Olive Leaf Daily Defense Broad Spectrum SPF 15 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 42421-716_38534f6c-f0b6-40fe-a1d5-b19a6f529785 42421-716 HUMAN OTC DRUG Evervescence Daily Facial Moisturizer Broad Spectrum SPF15 Sunscreen Avobenzone, Octocrylene CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. AVOBENZONE; OCTOCRYLENE 3; 10 g/100mL; g/100mL N 20181231 42421-775_58a5201f-1145-4068-bf72-9d3e6ccc4add 42421-775 HUMAN OTC DRUG Oil-Free Acne Wash Foaming Scrub Salicylic Acid GEL TOPICAL 20131205 OTC MONOGRAPH FINAL part333D Emilia Personal Care Inc. SALICYLIC ACID 2 g/100mL N 20181231 42421-792_65b9bb90-2d1d-4459-9083-6996c0662849 42421-792 HUMAN OTC DRUG Aureli Broad Spectrum AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE GEL TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 42421-802_2144566c-e39c-4f0f-a9f2-b69f93aaf261 42421-802 HUMAN OTC DRUG callyssee Beauty Faceguard Skin Protecting Facial Balm AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 5; 2.5; 1; 2 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL N 20181231 42421-814_974bb69c-e76e-49a6-b754-ad337250ac2f 42421-814 HUMAN OTC DRUG H-E-B Skin Corrective Innovative Skin Perfector BB Broad Spectrum SPF15 Sunscreen Light/Medium Titanium Dioxide, Octinoxate CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. TITANIUM DIOXIDE; OCTINOXATE 2.1; 4 g/100mL; g/100mL N 20181231 42421-815_51837bfc-3ccb-457f-a5f2-db8532ee148d 42421-815 HUMAN OTC DRUG Advanced Firming and Anti-Wrinkle Moisturizer Day Broad Spectrum SPF18 Sunscreen Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20140110 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g N 20181231 42421-821_50576262-1161-4f5b-9532-81bf1954256a 42421-821 HUMAN OTC DRUG Safe Harbor - Natural Sunscreen - Baby and Kids SPF50 Broad Spectrum Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140105 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. TITANIUM DIOXIDE; ZINC OXIDE 11.4; 4 g/100mL; g/100mL N 20181231 42421-875_4511ac61-1e6d-431c-a393-a8eb4c319a36 42421-875 HUMAN OTC DRUG Safe Harbor Natural Suncare Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20151115 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc TITANIUM DIOXIDE; ZINC OXIDE 9.4; 4.96 g/124g; g/124g N 20181231 42421-876_2a316868-c7ae-4c42-897d-030f08dac191 42421-876 HUMAN OTC DRUG Safe Harbor Natural Suncare Natural Sheer Mineral TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20161230 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc TITANIUM DIOXIDE; ZINC OXIDE 9.4; 4.96 g/124g; g/124g N 20181231 42421-926_e615176c-e829-4f5c-8d46-0fb405e9c1e2 42421-926 HUMAN OTC DRUG Safe Harbor - Natural - Sensitive SPF50 Broad Spectrum Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20140105 OTC MONOGRAPH NOT FINAL part352 Emilia Personal Care Inc. TITANIUM DIOXIDE; ZINC OXIDE 10.4; 4 g/100mL; g/100mL N 20181231 42423-270_80c3b9df-d1ca-459c-bdb9-34fa98e689bd 42423-270 HUMAN OTC DRUG EasyTouch Alcohol Prep Pads Nonsterile Isopropyl Alcohol SWAB TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part333A MHC Medical Products, LLC ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 42423-271_e73638c3-2de7-4a63-800f-46e933e73273 42423-271 HUMAN OTC DRUG EasyTouch Alcohol Prep Pads Sterile Isopropyl Alcohol SWAB TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part333A MHC Medical Products, LLC ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 42432-101_8bc29d96-e0f7-4290-a0a9-847ca98ac022 42432-101 HUMAN OTC DRUG Kiss Fungi-Gone Anti-fungal Treatment Tolnaftate LIQUID TOPICAL 20121023 OTC MONOGRAPH FINAL part333C Kiss Products, Inc. TOLNAFTATE 10 mg/mL E 20171231 42449-120_53bdbe99-08a4-45a4-b93b-65acd895315a 42449-120 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part333A Aero-Med Ltd ISOPROPYL ALCOHOL 1.4 mL/1 E 20171231 42449-210_5553f6f3-4b9d-4d9e-a683-713b888cc4f9 42449-210 HUMAN OTC DRUG BZK Antiseptic Benzalkonium Chloride SWAB TOPICAL 20120202 OTC MONOGRAPH NOT FINAL part333A Aero-Med Ltd BENZALKONIUM CHLORIDE 1 g/750g N 20181231 42452-378_131dfafb-a223-40a6-ac98-a7cbe8522c9c 42452-378 HUMAN OTC DRUG Revalife Topical menthol OINTMENT TOPICAL 20120126 OTC MONOGRAPH NOT FINAL part348 International Nutraceutical Company of America (INCA), LLC MENTHOL 937.5 mg/g N 20181231 42457-001_7f1b4835-29e7-43a6-892f-db57fcb621ea 42457-001 HUMAN PRESCRIPTION DRUG NutreStore glutamine POWDER, FOR SOLUTION ORAL 20080604 NDA NDA021667 Emmaus Medical, Inc. GLUTAMINE 5 g/1 Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 42457-420_40d66ddc-7703-4add-a34e-d9b0feb3a41e 42457-420 HUMAN PRESCRIPTION DRUG Endari Glutamine POWDER, FOR SOLUTION ORAL 20170707 NDA NDA208587 Emmaus Medical, Inc. GLUTAMINE 5 g/1 Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 42468-1001_c8baed93-6ae6-4bcc-b5cc-c812db1cc1ac 42468-1001 HUMAN OTC DRUG JAMU Sexty clove TABLET VAGINAL 20120502 UNAPPROVED DRUG OTHER JMBio Co., Ltd. CLOVE 18 mg/1 E 20171231 42469-1001_757313b9-0479-4e26-ad62-d60264831437 42469-1001 HUMAN OTC DRUG Bone Care ATRACTYLODES LANCEA ROOT TABLET ORAL 20120604 UNAPPROVED DRUG OTHER Evercarepharm Co., Ltd ATRACTYLODES LANCEA ROOT 170 mg/1 E 20171231 42469-2001_e1589433-4355-4d27-a5ff-0bdb7737d73b 42469-2001 HUMAN OTC DRUG Stomint ATRACTYLODES LANCEA ROOT TABLET ORAL 20120606 UNAPPROVED DRUG OTHER Evercarepharm Co., Ltd ATRACTYLODES LANCEA ROOT 70 mg/1 E 20171231 42469-3001_d098171e-4f75-4702-bbec-d6a50bb56c57 42469-3001 HUMAN OTC DRUG Green Body MACLURA TRICUSPIDATA WHOLE TABLET ORAL 20120703 UNAPPROVED DRUG OTHER Evercarepharm Co., Ltd MACLURA TRICUSPIDATA WHOLE 180 mg/1 E 20171231 42472-001_fe5bfddb-4c84-45d1-a48c-8e1d92961fab 42472-001 HUMAN OTC DRUG 24 HOUR ANTIPERSPIRANT NATURAL ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY SPRAY TOPICAL 19791001 OTC MONOGRAPH FINAL part350 ARAMIS INC. ALUMINUM CHLOROHYDREX PROPYLENE GLYCOL 10 mL/100mL N 20181231 42472-002_dc74ce6c-6e92-429b-846d-df428433dd2c 42472-002 HUMAN OTC DRUG LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20110424 OTC MONOGRAPH NOT FINAL part352 Aramis Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.4; 4; 2.5; 2.2; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 42472-004_120accec-8d04-4a85-8624-4dc817a77d09 42472-004 HUMAN OTC DRUG LAB SERIES SKIN SUPPLIES FOR MEN ANTIPERSPIRANT DEODORANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20150701 OTC MONOGRAPH FINAL part350 ARAMIS INC. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.6 g/100mL N 20181231 42472-695_57aa4879-7e8d-46bc-a98f-0cb422f0df24 42472-695 HUMAN OTC DRUG 24 HOUR HIGH PERFORMANCE ANTIPERSPIRANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 19840401 OTC MONOGRAPH FINAL part350 ARAMIS INC. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.6 mL/100mL N 20181231 42472-720_c23eb632-a3b9-49ff-b78a-f74c05bfc046 42472-720 HUMAN OTC DRUG ARAMIS LAB SERIES POWER PROTECTOR SPF 50 OCTISALATE, HOMOSALATE, AVOBENZONE, OXYBENZONE LOTION TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 ARAMIS INC OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 5; 5; 3; 3 mL/100mL; mL/100mL; 1/100mL; mL/100mL N 20181231 42472-887_0cc49c82-b0d8-4ae9-8985-028826430374 42472-887 HUMAN OTC DRUG LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, and OCTISALATE LOTION TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part352 ARAMIS INC. AVOBENZONE; OCTINOXATE; OCTISALATE .0212; .0795; .0318 g/100mL; g/100mL; g/100mL N 20181231 42475-002_5d6d8709-0d50-e6b1-e053-2a91aa0a1b74 42475-002 HUMAN OTC DRUG Coghlan s Sting Relief BENZOCAINE, PHENOL SPONGE TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part333A Coghlan's Ltd BENZOCAINE; PHENOL 50; 13.5 mg/mL; mg/mL N 20181231 42479-212_1e50c0d6-debd-4201-bae3-d33a3b646457 42479-212 HUMAN OTC DRUG footlogix Clotrimazole AEROSOL, SPRAY TOPICAL 20100901 OTC MONOGRAPH FINAL part333 KVG Group Inc CLOTRIMAZOLE 1 mL/100mL E 20171231 42479-213_1640faba-7234-4ef6-90c4-c8e55f860ffc 42479-213 HUMAN OTC DRUG footlogix intensive care diabetic formula Clotrimazole AEROSOL, FOAM TOPICAL 20120615 OTC MONOGRAPH FINAL part333C KVG Group Inc CLOTRIMAZOLE 1 g/100g E 20171231 42479-214_20ce9225-fb52-4a93-9b9a-3bfa36b17806 42479-214 HUMAN OTC DRUG footlogix moisturizing diabetic formula Dimethicone AEROSOL, FOAM TOPICAL 20120715 OTC MONOGRAPH FINAL part347 KVG Group Inc DIMETHICONE 1 g/100g E 20171231 42485-003_d95c940a-8f82-4928-8512-188b9f9224f0 42485-003 HUMAN OTC DRUG OC Eight benzoyl peroxide GEL TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333D Biopelle, Inc. BENZOYL PEROXIDE 7 mg/g E 20171231 42485-004_b022010d-4624-4cbc-baa7-93f29c5195b8 42485-004 HUMAN OTC DRUG LET ME BE PERFECTLY CLEAR benzoyl peroxide KIT 20110401 OTC MONOGRAPH NOT FINAL part333D Biopelle, Inc. E 20171231 42485-005_60eece35-7718-4cf2-e053-2991aa0af6a8 42485-005 HUMAN OTC DRUG Broad Spectrum SPF 30 Up The Anti TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Biopelle, Inc. TITANIUM DIOXIDE; ZINC OXIDE 32; 60 mg/mL; mg/mL N 20181231 42485-006_3aca1373-e465-44ff-8379-0366d682e837 42485-006 HUMAN OTC DRUG STOP THE CLOCK BROAD SPECTRUM SPF 50 avobenzone, homosalate, titanium dioxide, zinc oxide CREAM TOPICAL 20090801 OTC MONOGRAPH FINAL part352 Biopelle, Inc. AVOBENZONE; HOMOSALATE; TITANIUM DIOXIDE; ZINC OXIDE 30; 70; 35; 10 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 42485-007_51498b64-d362-4176-9944-ca4fc00c2953 42485-007 HUMAN OTC DRUG Lasting Results Moisturizer octocrylene, octinoxate, oxybenzone,octisalate, avobenzone LOTION TOPICAL 20120501 OTC MONOGRAPH FINAL part352 Biopelle, Inc. OCTOCRYLENE; OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE 100; 75; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 42494-301_ef127014-fe65-449a-a9e5-822834a11e58 42494-301 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20170501 UNAPPROVED DRUG OTHER Cameron Pharmaceuticals, LLC HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 42494-302_28a7490e-d0a8-412b-8876-5da3775a4cd3 42494-302 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20170501 UNAPPROVED DRUG OTHER Cameron Pharmaceuticals, LLC HYDROCORTISONE ACETATE 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 42494-339_ae17a4e2-d5a4-4f43-a061-a2deb442026a 42494-339 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20170726 NDA AUTHORIZED GENERIC NDA017001 Cameron Pharmaceuticals, LLC FLUCYTOSINE 250 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20191231 42494-340_ae17a4e2-d5a4-4f43-a061-a2deb442026a 42494-340 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20170726 NDA AUTHORIZED GENERIC NDA017001 Cameron Pharmaceuticals, LLC FLUCYTOSINE 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20191231 42494-400_64efd778-d06c-4289-95f6-ae1fbd6efd35 42494-400 HUMAN PRESCRIPTION DRUG NAPROXEN SODIUM DS naproxen sodium TABLET ORAL 20160710 NDA NDA018164 Cameron Pharmaceuticals, LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42494-402_64efd778-d06c-4289-95f6-ae1fbd6efd35 42494-402 HUMAN PRESCRIPTION DRUG NAPROXEN SODIUM naproxen sodium TABLET ORAL 20160710 NDA NDA018164 Cameron Pharmaceuticals, LLC NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42494-403_64efd778-d06c-4289-95f6-ae1fbd6efd35 42494-403 HUMAN PRESCRIPTION DRUG NAPROXEN naproxen TABLET ORAL 20160710 NDA NDA017581 Cameron Pharmaceuticals, LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42494-404_64efd778-d06c-4289-95f6-ae1fbd6efd35 42494-404 HUMAN PRESCRIPTION DRUG NAPROXEN naproxen TABLET ORAL 20160710 NDA NDA017581 Cameron Pharmaceuticals, LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42494-405_64efd778-d06c-4289-95f6-ae1fbd6efd35 42494-405 HUMAN PRESCRIPTION DRUG NAPROXEN naproxen TABLET ORAL 20160710 NDA NDA017581 Cameron Pharmaceuticals, LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42494-407_64efd778-d06c-4289-95f6-ae1fbd6efd35 42494-407 HUMAN PRESCRIPTION DRUG EC-NAPROXEN naproxen TABLET, DELAYED RELEASE ORAL 20160710 NDA NDA020067 Cameron Pharmaceuticals, LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42494-408_64efd778-d06c-4289-95f6-ae1fbd6efd35 42494-408 HUMAN PRESCRIPTION DRUG EC-NAPROXEN naproxen TABLET, DELAYED RELEASE ORAL 20160710 NDA NDA020067 Cameron Pharmaceuticals, LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 42494-409_82767eff-eaaf-4ea9-9c7e-0b04e9e95a52 42494-409 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 19660901 NDA AUTHORIZED GENERIC NDA012750 Cameron Pharmaceuticals, LLC CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] N 20181231 42495-004_43505d96-c582-433e-9bba-d19593dfa839 42495-004 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20150909 ANDA ANDA201003 MSM Repackaging RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 42495-170_9caaf4e7-9323-4974-b5e0-e9306d6a1b61 42495-170 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 Westwood Manufacturing HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 42495-266_9e656733-a7aa-43d2-b11f-e87f6e15d64d 42495-266 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20121015 ANDA ANDA090007 MSM Repackaging GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42495-556_cd30946c-4a89-4c53-801e-e0d1fc1c10aa 42495-556 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Westwood Manufacturing GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 42497-086_035b63b6-46d4-4c2f-b09f-1baab227bd2f 42497-086 HUMAN OTC DRUG E-2 Cleanser Sanitizer 86 Hand Sanitizer SOAP TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Penco Products, Inc. BENZALKONIUM CHLORIDE 2.5 g/100g E 20171231 42497-822_7b555ca2-7f7d-4b04-b1e4-f415cbe899c7 42497-822 HUMAN OTC DRUG Antibacterial Skin Cleanser 82 Antibacterial Hand Soap SOAP TOPICAL 20100304 OTC MONOGRAPH NOT FINAL part333 Penco Products, Inc. CHLOROXYLENOL 1 g/100g E 20171231 42507-001_8686d0d2-3987-4e2d-9ed0-1cf4e93dc44e 42507-001 HUMAN OTC DRUG cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20150506 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 42507-003_ec32df0e-85a8-437a-ac0b-ba73d024039f 42507-003 HUMAN OTC DRUG headache pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20150220 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 42507-004_2c3802c6-f542-4f25-b556-4e7ab1a3e9bc 42507-004 HUMAN OTC DRUG Kids Flouride Rinse Sodium Fluoride RINSE ORAL 20030911 OTC MONOGRAPH FINAL part355 Hy-Vee, Inc SODIUM FLUORIDE .05 kg/100L N 20181231 42507-005_143191e1-9db7-4011-9ea1-7aa9f5176c41 42507-005 HUMAN OTC DRUG Stool Softener Gentle Relief DOCUSATE SODIUM CAPSULE ORAL 20121215 OTC MONOGRAPH NOT FINAL part334 Hy-Vee DOCUSATE SODIUM 100 mg/1 E 20171231 42507-007_5169c67b-07e7-43f4-b81c-95253ad7febf 42507-007 HUMAN OTC DRUG Nasoflow Fluticasone propionate SPRAY, METERED NASAL 20160531 ANDA ANDA207957 HyVee Inc FLUTICASONE PROPIONATE 50 ug/1 N 20181231 42507-011_a26d6871-3d15-475b-b008-5ac40b892eae 42507-011 HUMAN OTC DRUG pain relief infants Acetaminophen SUSPENSION ORAL 20150415 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL N 20181231 42507-017_7cda25a7-8d2c-45de-88db-84381e04db73 42507-017 HUMAN OTC DRUG Sinus Congestion and Pain daytime nighttime Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate KIT 20160106 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-020_8d59e3ef-870b-45db-a3af-f77c578757a4 42507-020 HUMAN OTC DRUG Severe Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20150908 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 42507-023_685726c3-7d69-4468-84f6-4f729d6a7433 42507-023 HUMAN OTC DRUG cough and sore throat childrens Acetaminophen, Dextromethorphan HBr SUSPENSION ORAL 20150827 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL N 20181231 42507-025_bf5ebc1b-b94c-4034-84d3-bf6b075cab10 42507-025 HUMAN OTC DRUG cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20150924 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 42507-027_dfc502e9-356d-45f5-b744-9e5dbe627f9d 42507-027 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH NOT FINAL part343 Hy-Vee ASPIRIN 81 mg/1 N 20181231 42507-031_36ce78bf-0113-4999-a420-62130c5eae19 42507-031 HUMAN OTC DRUG day time nighttime cough dextromethorphan HBr, doxylamine succinate KIT 20120830 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-033_2345960f-c52d-4850-ad0c-70bd33e33339 42507-033 HUMAN OTC DRUG nighttime sleep aid Doxylamine succinate TABLET ORAL 20141204 ANDA ANDA040167 HyVee Inc DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 42507-035_9d6c9041-5d9e-4557-b848-75dd1b252865 42507-035 HUMAN OTC DRUG Mucus Relief Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Hy-Vee ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 42507-037_02c7f510-d097-4797-8ef8-198c2382d061 42507-037 HUMAN OTC DRUG Nasal Oxymetazoline hydrochloride SPRAY NASAL 20160812 OTC MONOGRAPH FINAL part341 HyVee Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 42507-039_b169480a-c2e6-49d0-b184-fb7a4345421a 42507-039 HUMAN OTC DRUG lubricant eye drops plus carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20161007 OTC MONOGRAPH FINAL part349 HyVee Inc CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM .5 g/100mL N 20181231 42507-049_ad7b2e2d-b97f-44d7-b58c-f7b87856590a 42507-049 HUMAN OTC DRUG Childrens Allergy Plus Congestion Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part341 Hy-Vee DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/5mL; mg/5mL N 20181231 42507-050_ab494313-9da2-4544-a875-1896ddf466ea 42507-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090302 ANDA ANDA079113 HyVee Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 42507-054_8c4c786c-2b0f-4a23-a87d-effbcfe0c857 42507-054 HUMAN OTC DRUG nasal decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000911 ANDA ANDA075153 HyVee Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 42507-056_13b39160-d126-4a62-8712-5349cc72ad00 42507-056 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140324 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 42507-057_5a989f9b-b521-41f3-82cb-af3a3e6b9d52 42507-057 HUMAN OTC DRUG ibuprofen infants ibuprofen SUSPENSION ORAL 20000903 ANDA ANDA075217 HyVee Inc IBUPROFEN 50 mg/1.25mL N 20181231 42507-058_69e932f9-68fc-4698-bc3e-13d6be3bfbd7 42507-058 HUMAN OTC DRUG LE TECHNIQ ANTIBACTERIAL HAND ISLAND CITRUS ETHYL ALCOHOL LIQUID TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 620 mg/mL N 20181231 42507-058_8d39032c-68d6-4c04-8976-f9252579f6a8 42507-058 HUMAN OTC DRUG LE TECHNIQ ANTIBACTERIAL HAND ISLAND CITRUS ETHYL ALCOHOL LIQUID TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 620 mg/mL N 20181231 42507-063_957c5ce6-528c-4c23-9d71-d1928a23956b 42507-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19980815 OTC MONOGRAPH FINAL part347 Hy-Vee, Inc FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 42507-065_92fd18bf-37f7-4171-91f5-bc90284d7668 42507-065 HUMAN OTC DRUG Nasal Extra Moisturizing Oxymetazoline HCl SPRAY NASAL 19990402 OTC MONOGRAPH FINAL part341 HyVee Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 42507-066_cbb01212-c472-4fd9-bfb6-a847e6bc3449 42507-066 HUMAN OTC DRUG Allergy Relief Extra Strength Nighttime Diphenhydramine HCl TABLET ORAL 20141130 OTC MONOGRAPH FINAL part338 Hy-Vee DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 42507-067_b2054219-88cc-442c-80d2-0dadcec0e805 42507-067 HUMAN OTC DRUG First Aid Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20150927 OTC MONOGRAPH FINAL part333B HyVee Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 42507-071_133d3590-4856-4eb7-8024-b533d3a34f91 42507-071 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50 percent Isopropyl alcohol LIQUID TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333A Hy-Vee ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 42507-072_a957e5cb-4b0d-4da7-baca-14ede882f173 42507-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 20010523 OTC MONOGRAPH NOT FINAL part348 Hy-Vee, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 42507-074_a61e7bdc-283f-4c0a-95d2-e3a0b3d0fa87 42507-074 HUMAN OTC DRUG ibuprofen ib Ibuprofen TABLET, COATED ORAL 20060514 ANDA ANDA077349 HyVee Inc IBUPROFEN 200 mg/1 N 20181231 42507-081_60880652-8a29-4af3-a59e-80bd2343bd14 42507-081 HUMAN OTC DRUG miconazole 3 Miconazole nitrate KIT 20090701 ANDA ANDA075329 HyVee Inc N 20181231 42507-082_e6a6e864-2ffb-44c7-937d-e174f716d088 42507-082 HUMAN OTC DRUG Allergy Relief Chlorpheniramine Maleate TABLET ORAL 20160929 OTC MONOGRAPH FINAL part341 HyVee Inc CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 42507-086_7e8275a6-111b-4eed-a807-41dd29199343 42507-086 HUMAN OTC DRUG Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20101108 OTC MONOGRAPH NOT FINAL part334 Hy-Vee BISACODYL 5 mg/1 N 20181231 42507-090_2f6818bd-9b50-4071-a11e-dce980ed2cb7 42507-090 HUMAN OTC DRUG Night Time Day Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20070924 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-090_6819f80c-ce43-4fa0-b985-d46145adc168 42507-090 HUMAN OTC DRUG day time night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110808 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-090_9c7448a5-3c0e-4c98-9c68-a7922c042fbc 42507-090 HUMAN OTC DRUG Day Time Night Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20070924 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-092_c5a04216-ed5b-495f-999b-4b94699a54ba 42507-092 HUMAN OTC DRUG Daytime Nighttime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine HCl KIT 20131130 OTC MONOGRAPH FINAL part341 Hy-Vee N 20181231 42507-094_d1925931-591f-477e-97d5-2a9f6c3d8cab 42507-094 HUMAN OTC DRUG nasal decongestant pe non drowsy Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20050523 OTC MONOGRAPH FINAL part341 HyVee Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 42507-096_e8334ce5-e038-4964-b3f9-d16d6a61c6ab 42507-096 HUMAN OTC DRUG Severe Cold Cough and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20150125 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 42507-100_a3d71451-eb8d-4c57-a39f-d01f70024cd8 42507-100 HUMAN OTC DRUG LE TECHNIQ SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 4.6 mg/mL N 20181231 42507-100_b4f112f5-4efb-4569-aa6b-ea1743e72582 42507-100 HUMAN OTC DRUG LE TECHNIQ SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 4.6 mg/mL N 20181231 42507-101_e549a01f-e8f2-4e35-85e4-d198e200db83 42507-101 HUMAN OTC DRUG pain relief infants Acetaminophen SUSPENSION ORAL 20150508 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL N 20181231 42507-102_51c00675-5137-460e-9b7c-feb275cdc3bf 42507-102 HUMAN OTC DRUG DayTime NightTime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine HCl KIT 20130930 OTC MONOGRAPH FINAL part341 Hy-Vee N 20181231 42507-105_09873b2a-4d7e-4426-a7e9-409d0a0b8eab 42507-105 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19970828 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL N 20181231 42507-109_c7b25971-02c1-4d79-b454-7ee937646799 42507-109 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170211 ANDA ANDA075077 HyVee Inc ACETAMINOPHEN 650 mg/1 N 20181231 42507-110_df265db0-6eed-4cf9-840f-9fef6ec3b172 42507-110 HUMAN OTC DRUG miconazole 7 Miconazole nitrate CREAM VAGINAL 20000215 ANDA ANDA074760 HyVee Inc MICONAZOLE NITRATE 2 g/100g N 20181231 42507-111_85cd3114-ddb4-41cb-91ac-af33ff7351bd 42507-111 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20140319 OTC MONOGRAPH NOT FINAL part334 HY-VEE, INC. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 42507-113_0c2595bf-4733-476d-91ae-b36e6fb2bd03 42507-113 HUMAN OTC DRUG LE TECHNIQ PEAR TRICLOSAN LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 4.6 mg/mL N 20181231 42507-113_992cdc2b-c045-460f-b7eb-ea148b579c88 42507-113 HUMAN OTC DRUG LE TECHNIQ PEAR TRICLOSAN LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 4.6 mg/mL N 20181231 42507-114_1aeca457-1924-4514-95e0-23619643d7bb 42507-114 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20120103 OTC MONOGRAPH FINAL part358F HY-VEE, INC SALICYLIC ACID 40 mg/91 N 20181231 42507-115_5c2bea94-d8a6-4eb4-80ab-3b24e01c3a8a 42507-115 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20171222 OTC MONOGRAPH FINAL part358F HY-VEE, INC SALICYLIC ACID 40 mg/41 N 20181231 42507-117_21a790a0-1474-430a-b54a-38e8007f61a9 42507-117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120521 ANDA ANDA202319 HyVee Inc LANSOPRAZOLE 15 mg/1 N 20181231 42507-120_487dbaef-9aa4-3fa0-e054-00144ff8d46c 42507-120 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20141125 OTC MONOGRAPH FINAL part341 Hy-Vee Inc. MENTHOL 5.4 mg/1 N 20181231 42507-121_487ee882-986e-203d-e054-00144ff88e88 42507-121 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20141125 OTC MONOGRAPH FINAL part341 Hy-Vee Inc. MENTHOL 5.8 mg/1 N 20181231 42507-122_487f34d7-9d15-184d-e054-00144ff8d46c 42507-122 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20141125 OTC MONOGRAPH FINAL part341 Hy-Vee Inc. MENTHOL 5.8 mg/1 N 20181231 42507-123_48823f99-e4c8-5f0c-e054-00144ff8d46c 42507-123 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20141125 OTC MONOGRAPH FINAL part341 Hy-Vee Inc. MENTHOL 7.5 mg/1 N 20181231 42507-124_48830d5e-7f3e-0f0d-e054-00144ff8d46c 42507-124 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20141125 OTC MONOGRAPH FINAL part341 HyVee Inc. MENTHOL 7.5 mg/1 N 20181231 42507-125_48a27c0a-9c81-02c7-e054-00144ff8d46c 42507-125 HUMAN OTC DRUG SF Cherry Cough Drop Menthol LOZENGE ORAL 20141125 OTC MONOGRAPH FINAL part341 HyVee Inc. MENTHOL 5.8 mg/1 N 20181231 42507-126_4883ccdf-0dff-579d-e054-00144ff88e88 42507-126 HUMAN OTC DRUG Strawberry Cough Drop Menthol LOZENGE ORAL 20141125 OTC MONOGRAPH FINAL part341 Hy-Vee Inc. MENTHOL 2.7 mg/1 N 20181231 42507-127_48a6d3f4-cffe-4cbf-e054-00144ff8d46c 42507-127 HUMAN OTC DRUG SF Honey Lemon Cough Drop Menthol LOZENGE ORAL 20141125 OTC MONOGRAPH FINAL part341 HyVee Inc. MENTHOL 7.6 mg/1 N 20181231 42507-128_48fb76e9-3846-69ba-e054-00144ff8d46c 42507-128 HUMAN OTC DRUG Herbal Cough Drop Menthol LOZENGE ORAL 20150611 OTC MONOGRAPH FINAL part341 Hy-Vee Inc. MENTHOL 4.8 mg/1 N 20181231 42507-129_4ab6b226-b343-1255-e054-00144ff88e88 42507-129 HUMAN OTC DRUG Cherry antacid soft chew calcium carbonate TABLET, CHEWABLE ORAL 20140828 OTC MONOGRAPH FINAL part331 HyVee Inc. CALCIUM CARBONATE 1177 mg/1 N 20181231 42507-130_e914ac97-5d8d-40ca-8c12-fc66c42cc6d9 42507-130 HUMAN OTC DRUG Pain Relief Childrens Acetaminophen SUSPENSION ORAL 19890815 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL N 20181231 42507-131_5d3009e9-86f5-468e-b391-0524d7159362 42507-131 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130413 ANDA ANDA078682 Hy-Vee IBUPROFEN 200 mg/1 N 20181231 42507-132_4cfe8c69-81b7-3e98-e054-00144ff8d46c 42507-132 HUMAN OTC DRUG Cold Relief Lozenges Zincum Gluconicum LOZENGE ORAL 20151028 UNAPPROVED HOMEOPATHIC HyVee Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 42507-133_a6fa5228-8fdc-4107-b672-7160ae5ba2fd 42507-133 HUMAN OTC DRUG Salicylic acid Wart Remover PLASTER TOPICAL 20171206 OTC MONOGRAPH FINAL part358B HY-VEE, INC SALICYLIC ACID .4 g/181 N 20181231 42507-134_be2647d3-65cc-4bc5-be6e-1965eee74688 42507-134 HUMAN OTC DRUG Salicylic Acid Medicated Plantar Wart Remover PATCH TOPICAL 20171222 OTC MONOGRAPH FINAL part358B HY-VEE, INC SALICYLIC ACID 40 mg/241 N 20181231 42507-135_d4500eab-839e-4a65-9766-af1de6c5a8da 42507-135 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20171222 OTC MONOGRAPH FINAL part333C HY-VEE, INC TOLNAFTATE 1.3 g/130g N 20181231 42507-136_4f9678c5-9e49-417e-b722-a043449bfd32 42507-136 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20171222 OTC MONOGRAPH FINAL part333C HY-VEE, INC TOLNAFTATE 1.5 g/150g N 20181231 42507-137_6f18fc26-64dc-4784-9f59-5108834f6d6a 42507-137 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20171222 OTC MONOGRAPH FINAL part358F HY-VEE, INC SALICYLIC ACID .17 g/9mL N 20181231 42507-138_f9e4f01e-9e3a-4901-83a3-d2c7933f570c 42507-138 HUMAN OTC DRUG Tolnaftate Jock Itch Powder AEROSOL, SPRAY TOPICAL 20120103 OTC MONOGRAPH FINAL part333C HY-VEE, INC TOLNAFTATE 1.3 g/130g N 20181231 42507-140_f897dd94-5441-46c4-a27c-40bf036929ef 42507-140 HUMAN OTC DRUG all day relief Naproxen sodium TABLET, FILM COATED ORAL 20080902 ANDA ANDA074661 HyVee Inc NAPROXEN SODIUM 220 mg/1 N 20181231 42507-141_a0f2683f-59ad-4f65-a108-696430d577ab 42507-141 HUMAN OTC DRUG acid reducer original strength Famotidine TABLET ORAL 20091019 ANDA ANDA075400 HyVee Inc FAMOTIDINE 10 mg/1 N 20181231 42507-144_7b2aae20-229d-4fff-93f5-fcc2d1f0b1ae 42507-144 HUMAN OTC DRUG Mucus Relief D Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20160418 ANDA ANDA091071 HyVee Inc GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 42507-145_bed15b0e-7453-4f46-9d3d-a763a209861a 42507-145 HUMAN OTC DRUG Mucus Relief cold and sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130708 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 42507-147_4ba77efb-690f-4e52-8907-fa2d9159052f 42507-147 HUMAN OTC DRUG Calamine Plus Pramoxine HCl Calamine Plus Spray AEROSOL, SPRAY TOPICAL 20171222 OTC MONOGRAPH NOT FINAL part348 HY-VEE, INC FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE .345; 24.16; 2.72 mg/116g; mg/116g; mg/116g N 20181231 42507-153_9be8b359-d644-4e76-962e-59910200bfd8 42507-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Hy-Vee Inc PYRITHIONE ZINC 1 kg/100L N 20181231 42507-157_8930d88c-fb40-4606-a585-318566ef5be1 42507-157 HUMAN OTC DRUG HYVEE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140319 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-158_e2f1e730-f3f1-4143-ab68-1f4d42406718 42507-158 HUMAN OTC DRUG HYVEE ANTISEPTIC MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140321 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-161_a9d9599c-06f6-464a-8e42-4a65d22de30c 42507-161 HUMAN OTC DRUG Pain and Fever Acetaminophen SUSPENSION ORAL 20110831 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL N 20181231 42507-165_2707d790-97b7-4e70-ae0c-40e323032d0b 42507-165 HUMAN OTC DRUG allergy and congestion relief Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20030630 ANDA ANDA075706 HyVee Inc PSEUDOEPHEDRINE SULFATE; LORATADINE 240; 10 mg/1; mg/1 N 20181231 42507-166_1414c9ec-597d-4acb-9fac-badbbeeacd01 42507-166 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020513 ANDA ANDA074937 HyVee Inc IBUPROFEN 100 mg/5mL N 20181231 42507-168_05e1d5e1-d6d7-4db7-b2c6-88e5f59c9497 42507-168 HUMAN OTC DRUG LE TECHNIQ FOAMING ANTIBACTERIAL HAND TRICLOSAN LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 6 mg/mL N 20181231 42507-174_e53a07e0-de15-4afa-bba8-d27e8467575a 42507-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA021920 Hy-Vee NAPROXEN SODIUM 220 mg/1 N 20181231 42507-175_214de7e6-c2b0-4d81-bf1a-6788b3bdc65d 42507-175 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19970828 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL N 20181231 42507-176_e822bbd0-d18f-4fb4-9d8e-ebbb55a81d0b 42507-176 HUMAN OTC DRUG All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080505 ANDA ANDA077170 HyVee Inc CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 42507-177_43fd2065-3b2f-4580-a2b7-a45baf91be0d 42507-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN SOLUTION TOPICAL 20110808 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .46 mL/100mL N 20181231 42507-178_2aeb1a9a-d762-447a-9467-1246ef119f07 42507-178 HUMAN OTC DRUG FOAMING ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .46 mL/100mL N 20181231 42507-179_01864a3a-814a-499c-a310-3b3a20495e6e 42507-179 HUMAN OTC DRUG calcium antacid extra strength Calcium carbonate TABLET, CHEWABLE ORAL 19970715 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 750 mg/1 N 20181231 42507-184_bf5b06f1-e62c-4ea3-88d4-8f475ab92620 42507-184 HUMAN OTC DRUG Headache relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET ORAL 20121015 OTC MONOGRAPH NOT FINAL part343 Hy-Vee ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 42507-187_0c3448e6-16e6-4347-8966-5c1342758f7a 42507-187 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET, COATED ORAL 19951109 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 N 20181231 42507-188_80e3af92-0827-46ed-846c-80b1949ee4ce 42507-188 HUMAN OTC DRUG HyVee Inc Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 HyVee Inc SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 42507-189_de6ff268-a67c-4c47-977d-363312ce64af 42507-189 HUMAN OTC DRUG HyVee Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 HyVee Inc SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 42507-190_94e31d02-8de2-42b5-8882-ed3ddc211fd9 42507-190 HUMAN OTC DRUG Bisacody Enteric Coated Bisacodyl TABLET, COATED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 Hy-Vee BISACODYL 5 mg/1 N 20181231 42507-197_93a14e19-feec-4c78-b84c-edea2bd2e71d 42507-197 HUMAN OTC DRUG HyVee Brilliant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 HyVee Inc SODIUM FLUORIDE .243 g/100g N 20181231 42507-198_50bf076e-84cc-4c6f-9933-0008b9c9e623 42507-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130115 ANDA ANDA078682 Hy-Vee IBUPROFEN 200 mg/1 N 20181231 42507-199_298c7241-44bb-4809-b5d7-1e58338a3199 42507-199 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100613 ANDA ANDA079114 HyVee Inc N 20181231 42507-200_76e2c3a6-1c7b-47a1-9e74-68b474944cb0 42507-200 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, FILM COATED ORAL 20140206 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 N 20181231 42507-201_625e089d-6fd1-4885-b7dc-70333b7af0af 42507-201 HUMAN OTC DRUG Cough Day Night dextromethorphan HBr, doxylamine succinate KIT 20150218 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-203_1c747f81-209a-4a42-81b4-f77b55a54353 42507-203 HUMAN OTC DRUG Childrens All Day Allergy Cetirizine HCl SOLUTION ORAL 20140217 ANDA ANDA204226 HyVee Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 42507-204_d3e3a861-6362-45e2-9659-fe6d560bee10 42507-204 HUMAN OTC DRUG Childrens 24 hour allergy nasal Fluticasone Propionate SPRAY, METERED NASAL 20160823 ANDA ANDA207957 HyVee Inc FLUTICASONE PROPIONATE 50 ug/1 N 20181231 42507-208_395a4948-b729-43ee-9c9a-36d8a02efc51 42507-208 HUMAN OTC DRUG Cold and Flu Day Night Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20141014 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-210_5585c3bc-f2d5-4710-89bc-94100ff0e79a 42507-210 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20100722 OTC MONOGRAPH NOT FINAL part348 Hy-Vee, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 42507-211_13978109-f41a-49f3-b4bd-4a0b77638165 42507-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20130930 NDA NDA022429 Hy-Vee CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 42507-213_03efde8e-67d9-416a-b01a-a876e283d900 42507-213 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20030806 OTC MONOGRAPH FINAL part355 Hy-Vee, Inc. SODIUM FLUORIDE .05 kg/100L N 20181231 42507-214_be7c50b4-d30b-4955-b06b-7336f254db64 42507-214 HUMAN OTC DRUG LE TECHNIQ ANTIBACTERIAL VANILLA BROWN SUGAR TRICLOSAN LIQUID TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .115 mL/100mL N 20181231 42507-217_08359ab1-9307-4365-a6d6-1862fc53eff4 42507-217 HUMAN OTC DRUG 8 hour pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050923 ANDA ANDA075077 HyVee Inc ACETAMINOPHEN 650 mg/1 N 20181231 42507-220_05be8eb5-0e55-48d7-913d-e9dfaae0e59c 42507-220 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .15 mL/100mL N 20181231 42507-224_9434cefe-6b13-47c4-b2f7-b8d566c5a4ff 42507-224 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030321 ANDA ANDA075232 HyVee Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 42507-227_dab025c3-1c49-41fb-93f5-93631ba2f636 42507-227 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, COATED ORAL 20060123 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 N 20181231 42507-230_ae19b818-a140-4107-9684-2a2271e732cb 42507-230 HUMAN OTC DRUG nighttime sleep aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20141124 OTC MONOGRAPH FINAL part338 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 42507-234_88ecdfb1-9c1a-432b-80fa-844f0223579d 42507-234 HUMAN OTC DRUG cold pain relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 19910215 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 42507-236_b10ccb84-8d55-416e-bce6-290ee82d5b7f 42507-236 HUMAN OTC DRUG Night Time Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Hy-Vee DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 42507-238_a7ca46b3-276f-4025-95ec-268dca08b7ea 42507-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130808 OTC MONOGRAPH NOT FINAL part334 Hy-Vee DOCUSATE SODIUM 100 mg/1 N 20181231 42507-240_934185ee-8f44-493c-b196-a548a22a467e 42507-240 HUMAN OTC DRUG FOAMING HAND SANITIZER BENZALKONIUM CHLORIDE GEL TOPICAL 20111024 OTC MONOGRAPH NOT FINAL part333E HY-VEE INC BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 42507-243_91e0958e-e26d-4bd9-ae26-278c587a6017 42507-243 HUMAN OTC DRUG pain relief infants Acetaminophen SUSPENSION ORAL 20150528 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL N 20181231 42507-244_c87bafed-21e0-41a5-a25f-4ba4b2b4654a 42507-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 Hy-Vee DOCUSATE SODIUM 100 mg/1 N 20181231 42507-247_63711c52-c8ed-4f77-a16b-cbf8dc4d0e13 42507-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140328 OTC MONOGRAPH NOT FINAL part343 Hy-Vee ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 42507-251_bc91799e-9de1-473f-8f2b-5bfc2f811395 42507-251 HUMAN OTC DRUG severe cold and flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20150113 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 42507-255_4ebc8307-6c6a-40bc-ab99-9d811f2519f4 42507-255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20050226 ANDA ANDA075217 HyVee Inc IBUPROFEN 50 mg/1.25mL N 20181231 42507-258_7a47dc23-36c1-4e21-8410-ae04a757b557 42507-258 HUMAN OTC DRUG STOOL SOFTENER Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 Hy-Vee DOCUSATE SODIUM 250 mg/1 N 20181231 42507-262_a9d41098-c485-4947-9e5a-babae14e7298 42507-262 HUMAN OTC DRUG LE TECHNIQ hAND SANITIZER APPLE POMEGRANATE ETHYL ALCOHOL LIQUID TOPICAL 20141116 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 620 mg/mL N 20181231 42507-262_eed8cac7-f872-4471-bdbe-f008151a405a 42507-262 HUMAN OTC DRUG LE TECHNIQ hAND SANITIZER APPLE POMEGRANATE ETHYL ALCOHOL LIQUID TOPICAL 20141116 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 620 mg/mL N 20181231 42507-266_41508428-344d-448e-8bce-a08e13ab8010 42507-266 HUMAN OTC DRUG LE TECHNIQ HAND SANITIZER JASMINE BASIL ETHYL ALCOHOL LIQUID TOPICAL 20141116 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 620 mg/mL N 20181231 42507-266_d8ea613c-1b3e-403f-9732-f61fb823235f 42507-266 HUMAN OTC DRUG LE TECHNIQ hAND SANITIZER JASMINE BASIL ETHYL ALCOHOL LIQUID TOPICAL 20141116 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 620 mg/mL N 20181231 42507-268_2d6f3857-3ef2-4c3c-8776-e8c4addb1dff 42507-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part356 Hy-Vee HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 42507-272_2138bc87-5ba6-46ae-a4cf-dd0d67c52fc8 42507-272 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20070211 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 42507-274_c9d2e2d8-e135-45c0-89fd-3dd3cc36b3ad 42507-274 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19970725 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ASPIRIN 81 mg/1 N 20181231 42507-275_6d4a6855-5931-4cbb-80af-5b53e8032993 42507-275 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 Percent Isopropyl Alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Hy-Vee ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 42507-277_cd0935a7-3bf8-45c9-ab25-df7c03c57d36 42507-277 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Hy-Vee ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 42507-279_b6c1728d-f4c9-4884-8f8b-1985e1f8afad 42507-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20150328 OTC MONOGRAPH FINAL part346 HyVee Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 42507-281_617d33cd-eba3-4ac6-b0ee-13991caa0fe6 42507-281 HUMAN OTC DRUG Dry Scalp Dandruff Pyrithione Zince SHAMPOO TOPICAL 20020719 OTC MONOGRAPH FINAL part358H Hy-Vee, Inc PYRITHIONE ZINC 1 kg/100L N 20181231 42507-282_d0daae1c-f6fb-4a23-9aa9-0f68b1aea3c7 42507-282 HUMAN OTC DRUG Dayhist allergy Clemastine fumarate TABLET ORAL 19960621 ANDA ANDA074512 HyVee Inc CLEMASTINE FUMARATE 1.34 mg/1 N 20181231 42507-284_2dd016b3-f842-4586-9e73-e2eecd1c6d8b 42507-284 HUMAN OTC DRUG Daytime Nighttime Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Guaifenesin, Phenylephrine HCl KIT 20150913 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-295_65140bd1-e731-4611-96a4-9116d465fe1b 42507-295 HUMAN OTC DRUG ANTIBACTERIAL CUCUMBER MELON TRICLOSAN LIQUID TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .115 mL/100mL N 20181231 42507-296_4a292529-49c3-4bb1-a34d-638687796a19 42507-296 HUMAN OTC DRUG tussin maximum strength dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20130225 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 42507-298_1ed16cb4-f00f-489e-8f94-efe48c805ae0 42507-298 HUMAN OTC DRUG LE TECHNIQ SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 1.5 mg/mL N 20181231 42507-298_a177302a-193f-467e-aa55-7767ea04d69d 42507-298 HUMAN OTC DRUG LE TECHNIQ SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 1.5 mg/mL N 20181231 42507-299_767e8000-92a7-45ac-b878-614bda8a7fc1 42507-299 HUMAN OTC DRUG Antiseptic Cetylpyridinium chloride 0.07% MOUTHWASH ORAL 20100218 OTC MONOGRAPH NOT FINAL part356 Hy-Vee, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 42507-300_e29bfe0d-1fa0-4c98-9962-ccb287ceb6aa 42507-300 HUMAN OTC DRUG Tussin Cough Long Acting Dextromethorphan Hydrobromide LIQUID ORAL 19951109 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL N 20181231 42507-301_b18c6b4e-c588-4a01-89c0-302bbdf89f7a 42507-301 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20160628 ANDA ANDA091429 HyVee Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 42507-302_21df4aaa-b101-44b0-b331-483f188ad594 42507-302 HUMAN OTC DRUG stomach relief original strength Bismuth subsalicylate SUSPENSION ORAL 19890215 OTC MONOGRAPH FINAL part335 HyVee Inc BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 42507-304_2fbaae08-abd4-482b-8241-5da710f443c5 42507-304 HUMAN OTC DRUG nasal original oxymetazoline hydrochloride SPRAY NASAL 19911118 OTC MONOGRAPH FINAL part341 HyVee Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 42507-306_0f45a719-73fe-4911-adfc-f9740d7b6747 42507-306 HUMAN OTC DRUG clear lax original prescription strength Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091011 ANDA ANDA090685 HyVee Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 42507-310_90fb2a9a-f427-438f-80ef-39f5901a49be 42507-310 HUMAN OTC DRUG adult tussin chest congestion Guaifenesin SOLUTION ORAL 19970625 OTC MONOGRAPH FINAL part341 HyVee Inc GUAIFENESIN 200 mg/10mL N 20181231 42507-311_5ef625fd-2b1c-4cb5-a9cc-6ab53917d70f 42507-311 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20061116 OTC MONOGRAPH FINAL part358H Hy-Vee Inc PYRITHIONE ZINC 1 kg/100L N 20181231 42507-314_159c4aad-c3f5-4edc-a179-8313159bd393 42507-314 HUMAN OTC DRUG multi symptom fever and cold childrens Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20150916 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 42507-316_2438c360-76d2-465f-bd09-141a0b3ce78e 42507-316 HUMAN OTC DRUG Severe Cold and Cough Relief Daytime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part341 Hy-Vee ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 42507-317_8c6cf00d-2c74-4305-9e38-a0e300a88dc8 42507-317 HUMAN OTC DRUG Severe Cold and Cough Relief Nighttime Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part341 Hy-Vee ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 42507-318_45153121-5c13-416a-a4c2-a683e2299bc2 42507-318 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 19900815 OTC MONOGRAPH NOT FINAL part356 Hy-Vee Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-319_b067335d-004d-4096-91be-391f354b33ba 42507-319 HUMAN OTC DRUG Anti Itch Hydrocortisone CREAM TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part348 HyVee Inc HYDROCORTISONE 1 g/100g N 20181231 42507-321_aba9ee53-1b93-44aa-9bdf-b777b6c8fc5c 42507-321 HUMAN OTC DRUG complete dual action famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080811 ANDA ANDA077355 HyVee Inc FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 42507-323_f2697a19-a69c-43d9-8959-55e3b1f49383 42507-323 HUMAN OTC DRUG lubricating plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130506 OTC MONOGRAPH FINAL part349 HyVee Inc CARBOXYMETHYLCELLULOSE SODIUM .5 g/100mL N 20181231 42507-325_90a499e3-ee02-48cc-bf46-a30aea038f51 42507-325 HUMAN OTC DRUG Mucus Relief Max Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160812 ANDA ANDA091009 HyVee Inc GUAIFENESIN 1200 mg/1 N 20181231 42507-329_c6ef96ce-98eb-4094-af85-496359e7074f 42507-329 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 Hy-Vee MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 42507-330_e8048e46-cf79-4230-979b-1de9c1d783bf 42507-330 HUMAN OTC DRUG Congestion Relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20141006 ANDA ANDA203200 HyVee Inc IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20181231 42507-332_88b54de6-b82e-4a8d-bb85-e4cfaa42bb74 42507-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19970502 OTC MONOGRAPH NOT FINAL part334 HyVee Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 42507-333_1810f2e9-34be-4361-8ece-f956046ffeac 42507-333 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131202 OTC MONOGRAPH FINAL part346 HyVee Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 42507-336_87179079-a9af-4142-9915-20a34b859693 42507-336 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Hy-Vee DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 650; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 42507-337_6a88d640-8e2f-4387-b871-b42db01abd16 42507-337 HUMAN OTC DRUG stomach relief Maximum Strength Bismuth subsalicylate SUSPENSION ORAL 19890715 OTC MONOGRAPH FINAL part335 HyVee Inc BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 42507-338_527b52d9-3f68-407e-aea1-5e9bc1264742 42507-338 HUMAN OTC DRUG Mucus Relief Maximum Strength DM Max Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Hy-Vee DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 42507-340_dc292573-80d6-420d-a923-001562724187 42507-340 HUMAN OTC DRUG antacid aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 19911021 20190324 OTC MONOGRAPH FINAL part331 HyVee Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 42507-345_0ae79bca-b483-44b0-83b4-f9611bc1561c 42507-345 HUMAN OTC DRUG severe sinus congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140519 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 42507-355_2ffd1d49-6825-4ed9-8a5d-b357b7b00ce9 42507-355 HUMAN OTC DRUG headache pm formula Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19980830 OTC MONOGRAPH FINAL part338 HyVee Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 42507-359_6554c6dd-c9f6-4cfd-8157-27637f608acc 42507-359 HUMAN OTC DRUG Tussin DM Adult Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19951010 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 42507-368_59c655b7-7303-4b08-a1aa-eb39f02931e7 42507-368 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET, FILM COATED ORAL 19970401 ANDA ANDA074661 HyVee Inc NAPROXEN SODIUM 220 mg/1 N 20181231 42507-370_f39d1fe2-93bd-4110-bf17-90e2891929bf 42507-370 HUMAN OTC DRUG Aspirin Safety Coated Aspirin TABLET, COATED ORAL 20140531 OTC MONOGRAPH FINAL part343 Hy-Vee ASPIRIN 325 mg/1 N 20181231 42507-373_4d101e67-52d2-4eca-a72a-2be7767d7499 42507-373 HUMAN OTC DRUG cold and cough Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20140602 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 42507-374_d6d3ed6c-e8e9-43a3-8927-8b1c7e8a285e 42507-374 HUMAN OTC DRUG migraine formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20020909 ANDA ANDA075794 HyVee Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 42507-379_eced84f7-dbcc-4dfb-abe4-bf3134ea7936 42507-379 HUMAN OTC DRUG allergy Diphenhydramine HCl SOLUTION ORAL 19921111 OTC MONOGRAPH FINAL part341 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 42507-381_04e02a2c-daf6-4901-93df-da6b4ed028b1 42507-381 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130624 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 42507-384_151bdc47-16ab-412c-ad39-f844d1858dc6 42507-384 HUMAN OTC DRUG cough dm dextromethorphan polistirex SUSPENSION ORAL 20120902 ANDA ANDA091135 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 42507-388_75cb03f0-f908-4fa7-a442-1a31754105c5 42507-388 HUMAN OTC DRUG nasal Oxymetazoline HCl SPRAY NASAL 20020513 OTC MONOGRAPH FINAL part341 HyVee Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 42507-396_a95747e4-8c56-4f4f-9d27-c88ace67bb41 42507-396 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 19970205 OTC MONOGRAPH NOT FINAL part334 HyVee Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 42507-401_ff67b14e-be6e-4758-ae02-1c9a8c3ef05b 42507-401 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20140115 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 42507-406_d8f6210b-68b9-4e57-909b-19e0b8767e55 42507-406 HUMAN OTC DRUG HyVee Cold Sore Treatment Benzalkonium Chloride CREAM TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Hyvee BENZALKONIUM CHLORIDE 1.3 mg/g N 20181231 42507-408_b271e16b-33ce-40bd-9780-837c8c9deb8a 42507-408 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20150131 ANDA ANDA078682 Hy-Vee IBUPROFEN 200 mg/1 N 20181231 42507-409_af25fc98-ca11-4bfe-bde3-6e8c1d2a7de1 42507-409 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19960528 OTC MONOGRAPH FINAL part340 HyVee Inc CAFFEINE 200 mg/1 N 20181231 42507-411_6fd329fe-fbbd-4583-b0f0-2b9278bd17c2 42507-411 HUMAN OTC DRUG cleartime Loratadine TABLET ORAL 20150216 ANDA ANDA076301 HyVee Inc LORATADINE 10 mg/1 N 20181231 42507-417_53eb244f-76fe-413a-a696-f55abd1c3ff6 42507-417 HUMAN OTC DRUG All Day Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130812 ANDA ANDA076518 HyVee Inc NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 42507-419_1291a34f-089c-41de-84cf-c3a902339566 42507-419 HUMAN OTC DRUG Severe Cold and Flu acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl TABLET, FILM COATED ORAL 20150908 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 42507-420_abd526a7-0a0d-4f80-b7c2-7aac454de980 42507-420 HUMAN OTC DRUG infants pain relief Acetaminophen SUSPENSION ORAL 20150518 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL N 20181231 42507-421_60cd47a7-e9c9-8563-e053-2a91aa0aaf7c 42507-421 HUMAN OTC DRUG HyVee Health Effervescent Cold Relief Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20141202 OTC MONOGRAPH FINAL part341 Hy-Vee Inc. ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE 325; 7.8; 2 mg/1; mg/1; mg/1 N 20181231 42507-424_a113e914-b7d4-43a0-bbef-4bf2a5a801c4 42507-424 HUMAN OTC DRUG Hyvee Care Classic Clean 2 in 1 Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20160613 OTC MONOGRAPH FINAL part358H Hyvee Inc PYRITHIONE ZINC 10 mg/mL N 20181231 42507-425_cf44e56e-19d8-4c5c-88e7-37c456c4d97a 42507-425 HUMAN OTC DRUG fexofenadine Fexofenadine HCl TABLET, FILM COATED ORAL 20111024 ANDA ANDA076447 HyVee Inc FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 42507-426_239953bb-5928-44e9-af95-74e539b30c5c 42507-426 HUMAN OTC DRUG Tioconazole Tioconazole OINTMENT VAGINAL 20080303 ANDA ANDA075915 HyVee Inc TIOCONAZOLE 6.5 g/100g N 20181231 42507-427_761224d3-cf68-4591-ae69-df0c25003b25 42507-427 HUMAN OTC DRUG Hyvee Care Classic Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20160613 OTC MONOGRAPH FINAL part358H Hyvee Inc PYRITHIONE ZINC 10 mg/mL N 20181231 42507-428_98dd2629-7b8f-4253-b03a-11f5bcadff2f 42507-428 HUMAN OTC DRUG gas relief extra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20030821 OTC MONOGRAPH FINAL part332 HyVee Inc DIMETHICONE 125 mg/1 N 20181231 42507-429_4356cab5-fa3c-4ff5-a119-3ff32ed4ce69 42507-429 HUMAN OTC DRUG Hyvee Care Dry Scalp Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20160613 OTC MONOGRAPH FINAL part358H Hyvee Inc PYRITHIONE ZINC 10 mg/mL N 20181231 42507-431_dca6f8c1-6948-4701-905c-1ca66cba5384 42507-431 HUMAN OTC DRUG sleep aid Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20010223 OTC MONOGRAPH FINAL part338 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 42507-432_541f124c-ec30-4601-b52e-ebb7aaea9cd5 42507-432 HUMAN OTC DRUG nasal decongestant non drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 19890115 OTC MONOGRAPH FINAL part341 HyVee Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 42507-437_d2039c6a-1133-4454-9d22-38209ba16b2f 42507-437 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19921119 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 42507-441_86c7d568-bcd9-43fa-adc8-4cfdfb57558a 42507-441 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 19980901 ANDA ANDA040167 HyVee Inc DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 42507-443_5ad719a7-3872-4d0c-93e6-603e4653ec42 42507-443 HUMAN OTC DRUG Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20161230 ANDA ANDA078104 HyVee Inc TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 42507-444_dcfa2c18-e476-43d4-9579-120a8e1f0412 42507-444 HUMAN OTC DRUG tussin multi symptom Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20141110 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 42507-448_e71f11ee-c4cc-4514-b605-801d91c3680e 42507-448 HUMAN OTC DRUG Hy-Vee Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 HYVEE INC LORATADINE 5 mg/5mL N 20181231 42507-458_7f37fe9d-ffad-4b4f-be85-7fffea58131c 42507-458 HUMAN OTC DRUG All Day Allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 19970828 ANDA ANDA078336 HyVee Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 42507-459_3bbbcf53-5a89-4d1f-a52c-5566b0955a1c 42507-459 HUMAN OTC DRUG night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110811 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 42507-461_2fd51545-1d1f-4b2e-a084-d28ba223e720 42507-461 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20050212 ANDA ANDA076359 HyVee Inc IBUPROFEN 100 mg/1 N 20181231 42507-462_11eed89e-b781-457f-867e-bf1ee6fe8cd0 42507-462 HUMAN OTC DRUG allergy diphenhydramine hydrochloride CAPSULE ORAL 19881215 OTC MONOGRAPH FINAL part341 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 42507-463_2b4c46de-93be-41f5-82bd-38a6414315a1 42507-463 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 19910730 OTC MONOGRAPH FINAL part341 HyVee Inc CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 42507-467_8a84f3e4-af5d-4583-8049-415a4520ded1 42507-467 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19951109 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ASPIRIN 81 mg/1 N 20181231 42507-468_3296c7e5-5ca1-4d97-b947-3606d2b0d884 42507-468 HUMAN OTC DRUG antacid Calcium carbonate TABLET, CHEWABLE ORAL 19961007 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 750 mg/1 N 20181231 42507-475_2643640e-d144-41ae-919f-37be23e547aa 42507-475 HUMAN OTC DRUG childrens all day allergy Cetirizine HCl SOLUTION ORAL 20160320 ANDA ANDA204226 HyVee Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 42507-477_94baeee4-6d29-465c-8127-1cb0175a7a1b 42507-477 HUMAN OTC DRUG fiber laxative Calcium polycarbophil TABLET, FILM COATED ORAL 19980706 OTC MONOGRAPH NOT FINAL part334 HyVee Inc CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 42507-478_4ec3c2be-3f3a-47fd-a4f9-9569d5a777d5 42507-478 HUMAN OTC DRUG antacid calcium carbonate TABLET, CHEWABLE ORAL 19920828 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 500 mg/1 N 20181231 42507-479_def2e1e7-1e19-47c5-8554-b9e964c5f61c 42507-479 HUMAN OTC DRUG allergy Diphenhydramine Hydrochloride TABLET ORAL 20160301 OTC MONOGRAPH FINAL part341 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 42507-480_ee2a43cd-3194-4b01-89ad-29733ca9f872 42507-480 HUMAN OTC DRUG LE TECHNIQ ALOE ETHYL ALCOHOL LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 700 mg/mL N 20181231 42507-483_746e0f1f-e21d-4653-a058-63686c2d6472 42507-483 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20151130 OTC MONOGRAPH FINAL part336 Hy-Vee DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 42507-484_1235af6c-7f52-411e-ba21-6ec9989857a9 42507-484 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 19910515 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 N 20181231 42507-485_1573ad73-5f10-4b20-a6ad-9f76459eec2b 42507-485 HUMAN OTC DRUG Antacid calcium carbonate TABLET, CHEWABLE ORAL 19890115 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 500 mg/1 N 20181231 42507-489_71a06186-2e91-40e0-a49d-56acae52e599 42507-489 HUMAN OTC DRUG antacid Calcium carbonate TABLET, CHEWABLE ORAL 20010223 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 750 mg/1 N 20181231 42507-490_e593d39d-64d1-40be-b853-276c23a9db18 42507-490 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET ORAL 19970401 ANDA ANDA074661 HyVee Inc NAPROXEN SODIUM 220 mg/1 N 20181231 42507-492_b07b95bd-085c-46b3-a988-7f0a5b520e7d 42507-492 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20160229 OTC MONOGRAPH NOT FINAL part334 Hy-Vee SENNOSIDES 25 mg/1 N 20181231 42507-494_20c10d74-0435-4e8a-acd7-5af1f8382c28 42507-494 HUMAN OTC DRUG cough dm dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150518 ANDA ANDA091135 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 42507-499_ea93327c-4f9a-438d-96bf-1e205ad5d545 42507-499 HUMAN OTC DRUG LE TECHNIQ ALOE ETHYL ALCOHOL LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC ALCOHOL 700 mg/mL N 20181231 42507-500_6892fddb-b8f7-4257-8345-461c171058a9 42507-500 HUMAN OTC DRUG Cough Dextromethorphan HBr SOLUTION ORAL 20140212 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL N 20181231 42507-503_348e3935-9d65-4b0f-95fa-d99aed8dcd79 42507-503 HUMAN OTC DRUG Severe Cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20160812 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 42507-505_5821fb1f-aca0-4bb2-9e42-3ab74e1284c6 42507-505 HUMAN OTC DRUG Mucus Relief DM Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 Hy-Vee DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 42507-507_3d373b6d-5aee-4b54-9d67-6313f76d949d 42507-507 HUMAN OTC DRUG Clear Time Oxymetazoline Hydrochloride SPRAY NASAL 20150719 OTC MONOGRAPH FINAL part341 HyVee Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 42507-515_2970a32c-63fb-4313-93b2-f2ed3f8b9408 42507-515 HUMAN OTC DRUG Daytime Nighttime ClearTime Acetaminophen, Doxylamine succinate , Phenylephrine HCl KIT 20150207 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-517_52cf3483-d5ec-4b35-9357-e02bbd88cc6a 42507-517 HUMAN OTC DRUG ibuprofen ib Ibuprofen TABLET, FILM COATED ORAL 20060521 ANDA ANDA077349 HyVee Inc IBUPROFEN 200 mg/1 N 20181231 42507-520_7e2fe4e6-bc61-4a73-b6ba-2775dcec3e3a 42507-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20160630 NDA NDA021855 Hy-Vee LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 42507-522_0ea1b658-aeb0-457e-babe-a013cea284bc 42507-522 HUMAN OTC DRUG Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20140110 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 42507-525_08106f50-e1b5-4561-a580-0c0ee21c2f48 42507-525 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20160731 OTC MONOGRAPH NOT FINAL part343 Hy-Vee ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 42507-528_6bfb13cf-eff1-4e13-bfd5-18ea387b972a 42507-528 HUMAN OTC DRUG Antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 19961120 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 750 mg/1 N 20181231 42507-539_d8362f3a-683e-485d-9cbb-c37f3fa0c1c4 42507-539 HUMAN OTC DRUG allergy relief Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20140922 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 42507-544_e88e0d63-00f5-48c3-bece-48d798acb892 42507-544 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051106 ANDA ANDA075077 HyVee Inc ACETAMINOPHEN 650 mg/1 N 20181231 42507-546_a7dee434-3774-468f-b7d0-b7e286d63828 42507-546 HUMAN OTC DRUG complete dual action Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080811 ANDA ANDA077355 HyVee Inc FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 42507-548_d1ec88a0-b636-47b8-9936-1aa90997f5cd 42507-548 HUMAN OTC DRUG Severe Cold and Flu acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140201 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 42507-552_2dd7bcd9-ec57-4b39-974c-9cd8166e1c3a 42507-552 HUMAN OTC DRUG HYVEE COMPLETE CARE FRESH MINT SODIUM FLUORIDE LIQUID ORAL 20130912 OTC MONOGRAPH FINAL part355 HYVEE INC. SODIUM FLUORIDE .2 mg/mL N 20181231 42507-553_8266845c-3393-4789-a189-481cbeb228d6 42507-553 HUMAN OTC DRUG HYVEE PRO CLEAN BLUE MINT CETYLPYRIDINIUM CHLORIDE LIQUID ORAL 20130912 OTC MONOGRAPH NOT FINAL part356 HYVEE INC. CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 42507-554_6ad57f6e-a256-4f25-9206-cf0822da1a50 42507-554 HUMAN OTC DRUG HYVEE ANTICAVITY MINT SODIUM FLUORIDE LIQUID ORAL 20151129 OTC MONOGRAPH FINAL part355 HYVEE INC. SODIUM FLUORIDE .5 mg/mL N 20181231 42507-556_841a02ad-658b-4ea2-ba10-11115f3ba570 42507-556 HUMAN OTC DRUG HYVEE ANTISEPTIC ORIGINAL EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130912 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-556_96112b5f-5b0b-42f5-bf80-6ff42d267dc7 42507-556 HUMAN OTC DRUG HYVEE ANTISEPTIC ORIGINAL EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20160302 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-557_9cf200be-acff-4fe7-bad0-1a1cdbaadfcb 42507-557 HUMAN OTC DRUG HYVEE ANTISEPTIC MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130912 OTC MONOGRAPH NOT FINAL part356 HYVEE INC. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-557_b9b42143-8af4-465e-881f-28851cc4058a 42507-557 HUMAN OTC DRUG HYVEE ANTISEPTIC MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130912 OTC MONOGRAPH NOT FINAL part356 HYVEE INC. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-558_4f94303c-17d7-4665-b2e4-2f5370f5a934 42507-558 HUMAN OTC DRUG HYVEE ANTISEPTIC BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20160302 OTC MONOGRAPH NOT FINAL part356 HYVEE INC. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-558_ce7e359e-f064-4874-a5a2-b9782f4b384e 42507-558 HUMAN OTC DRUG HYVEE ANTISEPTIC BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130912 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-558_d3f9f4dd-7a70-4acd-8df8-bfcca64b36c7 42507-558 HUMAN OTC DRUG HYVEE ANTISEPTIC BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20150809 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-559_bf9105a3-4bed-4b02-92d3-9b0354528cbc 42507-559 HUMAN OTC DRUG HYVEE ANTISEPTIC BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20150408 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-560_3d9ef9cf-137c-4e97-9f0c-139b1539fcfc 42507-560 HUMAN OTC DRUG HYVEE ANTISEPTIC MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20150408 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-560_4e921497-5cab-4fdc-85c5-715015e3a927 42507-560 HUMAN OTC DRUG HYVEE ANTISEPTIC MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20150809 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-561_db4f3c51-759a-4f92-8d72-867c1ad4649c 42507-561 HUMAN OTC DRUG HYVEE HEALTH COOL BLUE SUGAR FREE EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 20160308 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-562_e169459a-3abe-4ff5-9217-c5b026785dce 42507-562 HUMAN OTC DRUG HYVEE HEALTH GREEN MINT SUGAR FREE EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 20160308 OTC MONOGRAPH NOT FINAL part356 HYVEE INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; 1/mL; 1/mL N 20181231 42507-567_52b34580-00a0-4988-bc8a-ef481094eab9 42507-567 HUMAN OTC DRUG Night Time Day Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120105 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-567_71df4af2-027c-4658-86e9-101919de096b 42507-567 HUMAN OTC DRUG Day Time Night Time Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120101 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-578_31a6369c-9be4-4d76-bc77-ecade8864b55 42507-578 HUMAN OTC DRUG tussin dm adult Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 19961120 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 42507-580_c0696f92-61f9-4a3d-8b82-ed5bd025205d 42507-580 HUMAN OTC DRUG Day Night Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140702 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-588_d89b6971-f078-429f-87fd-219b24ca29ed 42507-588 HUMAN OTC DRUG Antacid Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Simethicone LIQUID ORAL 20060730 OTC MONOGRAPH FINAL part332 HyVee Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 42507-590_040b1c43-d523-41b8-8438-50f97f5c8141 42507-590 HUMAN OTC DRUG pain and fever acetaminophen SUSPENSION ORAL 19930805 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL N 20181231 42507-595_65dd1fcd-c733-4396-a4b3-69ee554536ac 42507-595 HUMAN OTC DRUG antacid Calcium Carbonate TABLET, CHEWABLE ORAL 19961120 OTC MONOGRAPH FINAL part331 HyVee Inc CALCIUM CARBONATE 1000 mg/1 N 20181231 42507-597_a90253e1-9f95-441f-8acd-a22045762266 42507-597 HUMAN OTC DRUG Severe Cold and Flu Nighttime Daytime acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140519 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-601_dd76140d-6511-4cd4-89e8-22df5b743dd6 42507-601 HUMAN OTC DRUG Pain Relief Acetaminophen CAPSULE, COATED ORAL 20151101 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 N 20181231 42507-603_793b7379-37da-4b27-8914-2afc4562f6e9 42507-603 HUMAN OTC DRUG Severe Cold and Flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20140112 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 42507-604_70791539-e8ab-407d-8d71-11d0b3e0ab95 42507-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19910315 ANDA ANDA072096 HyVee Inc IBUPROFEN 200 mg/1 N 20181231 42507-611_df65908c-79a0-42f0-aec6-fb009aef6016 42507-611 HUMAN OTC DRUG LeThechniq Dandruff Moisturizing Selenium Sulfide SHAMPOO TOPICAL 20101015 OTC MONOGRAPH FINAL part358H HY-VEE, Inc SELENIUM SULFIDE 1 mL/100mL N 20181231 42507-612_947621fd-7c6a-4c20-b4f6-9b994029265e 42507-612 HUMAN OTC DRUG Allergy Relief Loratadine TABLET ORAL 20050523 ANDA ANDA076301 HyVee Inc LORATADINE 10 mg/1 N 20181231 42507-620_6232c831-7b01-49ae-8781-52fbe4b4d825 42507-620 HUMAN OTC DRUG Motion Sickness Meclizine HCl TABLET ORAL 20140328 OTC MONOGRAPH FINAL part336 Hy-Vee MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 42507-622_53157137-b980-45d2-aa10-8c111c0ec2f4 42507-622 HUMAN OTC DRUG Itch Stopping Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20150927 OTC MONOGRAPH NOT FINAL part348 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 42507-645_315e9aa8-2d64-4c58-bd3c-3a66aa1208a8 42507-645 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120430 ANDA ANDA091292 HyVee Inc LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 42507-647_5b365b3e-8550-4194-8edf-630ed45e833d 42507-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 19890715 ANDA ANDA072096 HyVee Inc IBUPROFEN 200 mg/1 N 20181231 42507-648_80757c82-5fda-421e-ab13-6a8d097c3fa5 42507-648 HUMAN OTC DRUG Nasal Four Phenylephrine hydrochloride SPRAY NASAL 20030503 OTC MONOGRAPH FINAL part341 HyVee Inc PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 42507-656_d7980971-5bd3-4e15-971d-71b0e82517b7 42507-656 HUMAN OTC DRUG day time acetaminophen, dextromethorphan Hbr, Phenylephrine HCl LIQUID ORAL 20060611 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 42507-660_06b40b91-9a23-437c-b0b4-9f3094515e5d 42507-660 HUMAN OTC DRUG Ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020401 ANDA ANDA074937 HyVee Inc IBUPROFEN 100 mg/5mL N 20181231 42507-664_f2d3f64e-e7c1-4c07-9bb3-f00df65109a4 42507-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19921120 OTC MONOGRAPH NOT FINAL part356 Hy-Vee, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42507-666_aa21d296-46ad-48d3-8fd7-ea717e1ac3ae 42507-666 HUMAN OTC DRUG cough and sore throat pain relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20080720 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 42507-668_db52ea79-55e0-4725-a0ba-ede531f1a50d 42507-668 HUMAN OTC DRUG Nighttime Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20030420 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 42507-679_69a4b642-b7ec-43cc-aa57-6858da0b3d63 42507-679 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20150927 OTC MONOGRAPH FINAL part333B HyVee Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 42507-685_c8d685f9-5ca5-4024-96cb-3428b70724b2 42507-685 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 19970930 ANDA ANDA074937 HyVee Inc IBUPROFEN 100 mg/5mL N 20181231 42507-692_2d907ff8-d171-448c-9364-f5880f97ceda 42507-692 HUMAN OTC DRUG allergy relief fexofenadine hcl TABLET, FILM COATED ORAL 20140212 ANDA ANDA076447 HyVee Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 42507-700_5bac02bb-8c72-4f03-84bc-60de2e02bfac 42507-700 HUMAN OTC DRUG cold and flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20140924 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 42507-702_10acb6f6-1391-4f6d-a3d5-274bd9cb122b 42507-702 HUMAN OTC DRUG Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20140307 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-705_69b78e81-cb21-4a4a-a841-8ba17c1c95a6 42507-705 HUMAN OTC DRUG mucus relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20141001 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 42507-719_6e757d28-b6df-471e-a781-4a374b4efe79 42507-719 HUMAN OTC DRUG LE TECHNIQ MORNING MIST ANTIBACTERIAL HAND TRICLOSAN LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN 1.15 mg/mL N 20181231 42507-720_47876240-6fd7-494e-bcac-95cd8964c961 42507-720 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .115 mL/100mL N 20181231 42507-720_5ee1ecd3-fa1b-4b72-89b3-7e2052a14274 42507-720 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E HYVEE INC TRICLOSAN .115 mL/100mL N 20181231 42507-721_6bfa55be-68f5-42ba-b947-c913edfc4fc0 42507-721 HUMAN OTC DRUG LE TECHNIQ LIGHT MOISTURIZING BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 42507-721_c42c3ef2-6057-410a-8d4c-d7b465b6f019 42507-721 HUMAN OTC DRUG LE TECHNIQ LIGHT MOISTURIZING BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130919 OTC MONOGRAPH NOT FINAL part333E HYVEE INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 42507-724_e7de712c-d94e-45d5-9448-af643fa2e3be 42507-724 HUMAN OTC DRUG allergy and congestion relief non drowsy Pseudoephedrine sulfate, Loratadine TABLET, FILM COATED ORAL 20101026 ANDA ANDA075989 HyVee Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 42507-732_8257bb12-d422-4b5d-a178-ff786641105c 42507-732 HUMAN OTC DRUG Omeprazole and sodium bicarbonate Omeprazole, sodium bicarbonate CAPSULE, GELATIN COATED ORAL 20171130 ANDA ANDA201361 HyVee Inc OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 N 20181231 42507-735_0ae4d541-841c-4a2e-a509-d4ca119efa7d 42507-735 HUMAN OTC DRUG Mucus Relief DM Max Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160812 ANDA ANDA091070 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 42507-737_46a9a315-36e8-4abf-9066-81cb7d5897d7 42507-737 HUMAN OTC DRUG miconazole 1 Miconazole nitrate KIT 20100613 ANDA ANDA079114 HyVee Inc N 20181231 42507-751_e9b05ddc-afc2-4b57-ad34-fdaadf325e81 42507-751 HUMAN OTC DRUG pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20120507 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 42507-759_14c82f36-6cc1-4f86-8f61-f3b0e19212a3 42507-759 HUMAN OTC DRUG pain relief Acetaminophen SUSPENSION ORAL 20110919 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL N 20181231 42507-763_36412c73-4347-47c3-b0bf-a9cef77c7e77 42507-763 HUMAN OTC DRUG Severe Cold and Flu Night time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140112 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 42507-766_53184e1d-6c19-4ec9-be25-32ef7f73dc11 42507-766 HUMAN OTC DRUG infants pain and fever Acetaminophen SUSPENSION ORAL 20120305 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL N 20181231 42507-799_e4edbf6d-25ef-467f-a636-ed57090b4ad2 42507-799 HUMAN OTC DRUG tussin dm max adult cough and chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20100809 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 42507-800_9ad68e6e-481f-4c03-9bce-a488f8a88ad8 42507-800 HUMAN OTC DRUG cough Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20160303 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 42507-801_7d40d41a-d241-4a12-9b81-b42545dc9578 42507-801 HUMAN OTC DRUG Antibacterial Body Wash Spring Water 2 in 1 Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E HY-VEE, Inc TRICLOSAN .15 mL/100mL N 20181231 42507-806_910d5f7d-b567-488b-bb0b-bc2de2154a3f 42507-806 HUMAN OTC DRUG allergy relief Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20150307 ANDA ANDA076447 HyVee Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 42507-807_d2b7a77f-f080-40fd-92c9-be90807ab892 42507-807 HUMAN OTC DRUG cold remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20080811 UNAPPROVED HOMEOPATHIC HyVee Inc ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 42507-810_c7425a30-802e-4585-bc5a-02e32e2c60fb 42507-810 HUMAN OTC DRUG Sinus and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20140228 OTC MONOGRAPH FINAL part341 Hy-Vee CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 42507-815_f1a9c8b4-6e55-4698-8272-6558f2e648dc 42507-815 HUMAN OTC DRUG HyVee Alcohol Prep Pads Isopropyl Alcohol SWAB TOPICAL 20140507 OTC MONOGRAPH NOT FINAL part333A HY-VEE, INC. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 42507-818_55870abb-0f4d-4f68-9b1c-d47bf4759ba3 42507-818 HUMAN OTC DRUG 24 Hour Allergy Nasal Fluticasone propionate SPRAY, METERED NASAL 20160808 ANDA ANDA207957 HyVee Inc FLUTICASONE PROPIONATE 50 ug/1 N 20181231 42507-825_1405e7e3-70bc-46b0-9547-1c10bce7c621 42507-825 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20151031 OTC MONOGRAPH FINAL part335 Hy-Vee BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 42507-837_89155a22-5ee5-4df4-bb9f-53e130e7ddb7 42507-837 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 19980128 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 42507-839_d39f164b-6f21-4076-aba3-1ca3ddbc3149 42507-839 HUMAN OTC DRUG Childrens mucus relief dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20140303 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 42507-852_6b1a7695-bc32-45d4-bd3a-534842e59259 42507-852 HUMAN OTC DRUG Ranitidine Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20131202 ANDA ANDA091429 HyVee Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 42507-857_0ceeab10-ba98-44b8-bcbc-959b2bdadba8 42507-857 HUMAN OTC DRUG Antifungal Foot Clotrimazole CREAM TOPICAL 20151128 OTC MONOGRAPH FINAL part333C HyVee Inc CLOTRIMAZOLE 1 g/100g N 20181231 42507-866_59ad8636-8e84-428f-9447-573c2d95b0a6 42507-866 HUMAN OTC DRUG lice treatment Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070826 OTC MONOGRAPH FINAL part358G HyVee Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 42507-873_6158e780-cdf3-2c5b-e053-2991aa0aeab0 42507-873 HUMAN OTC DRUG HyVee Health Effervescent Antacid and Pain Relief Aspirin, Citric Acid, Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20141203 OTC MONOGRAPH FINAL part343 Hy-Vee Inc. ASPIRIN; SODIUM BICARBONATE; ANHYDROUS CITRIC ACID 325; 1916; 1000 mg/1; mg/1; mg/1 N 20191231 42507-882_efd3e440-5a87-4bd9-aa2b-65407f32800f 42507-882 HUMAN OTC DRUG Infants Gas Relief Simethicone EMULSION ORAL 20080720 OTC MONOGRAPH FINAL part332 HyVee Inc DIMETHICONE 20 mg/.3mL N 20181231 42507-886_abbe06ff-f0c6-4934-93d9-557805714010 42507-886 HUMAN OTC DRUG sinus Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20071001 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-890_3a4632cb-bfd4-4b4b-a6c0-75b91f391f31 42507-890 HUMAN OTC DRUG Cold and Allergy Maximum strength Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20160831 OTC MONOGRAPH FINAL part341 Hy-Vee CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 42507-896_b1e606b0-cfac-4930-85d3-bd6ab42c8b4d 42507-896 HUMAN OTC DRUG Lubricant Eye Polyethylene glycol, Propylene glycol SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130610 OTC MONOGRAPH FINAL part349 HyVee Inc POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL N 20181231 42507-897_7348833e-d1c6-4931-a8d7-db760e7b26e4 42507-897 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION ORAL 19990305 ANDA ANDA074937 HyVee Inc IBUPROFEN 100 mg/5mL N 20181231 42507-899_81cb5ece-7ef3-41cd-bafb-002925421c15 42507-899 HUMAN OTC DRUG cough dm childrens Dextromethorphan polistirex SUSPENSION ORAL 20150518 ANDA ANDA091135 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 42507-901_6f7cbc9e-fb95-4667-bd06-c0b6afd042b7 42507-901 HUMAN OTC DRUG Tussin Nighttime Cough Control dextromethorphan hbr, doxylamine succinate SOLUTION ORAL 20160812 OTC MONOGRAPH FINAL part341 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL N 20181231 42507-913_9f1215f9-433c-4f91-aeb1-3b130a628644 42507-913 HUMAN OTC DRUG Childrens Triacting Diphenhydramine HCl, Phenylephrine HCl SOLUTION ORAL 20080428 OTC MONOGRAPH FINAL part341 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 42507-915_88b79ac6-3ba8-4c56-b388-2f28516bf58b 42507-915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080302 NDA NDA022032 HyVee Inc OMEPRAZOLE 20 mg/1 N 20181231 42507-920_d215c38d-7a2b-49e4-b94d-f512028c21ab 42507-920 HUMAN OTC DRUG cold multi symptom acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20151004 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 42507-942_808e5606-05fa-4e60-b851-ee6c4c340cf1 42507-942 HUMAN OTC DRUG cold and flu Acetaminophen, diphenhydramine HCl, phenylephrine HCl TABLET, FILM COATED ORAL 20150111 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 42507-944_b867f691-7a13-4659-b664-06aa36899310 42507-944 HUMAN OTC DRUG Hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20080811 OTC MONOGRAPH FINAL part346 HyVee Inc GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 42507-946_a10db5cc-cbf5-4017-a6c3-30a3a6a6c485 42507-946 HUMAN OTC DRUG pain and fever infants Acetaminophen SUSPENSION ORAL 20110831 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 160 mg/5mL N 20181231 42507-949_577df0ed-c19c-46da-b2ce-d6e30ecdb074 42507-949 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20050718 OTC MONOGRAPH NOT FINAL part334 HyVee Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 42507-950_f60c0f6a-b29c-4f0c-bb7d-9a0233638ac9 42507-950 HUMAN OTC DRUG acid reducer 150 Ranitidine TABLET, FILM COATED ORAL 20120917 ANDA ANDA091429 HyVee Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 42507-951_08c636f5-7d98-46d5-9934-e8623081727c 42507-951 HUMAN OTC DRUG Daytime Mucus Relief Nighttime Cold and Flu Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, diphenhydramine HCl KIT 20150908 OTC MONOGRAPH FINAL part341 HyVee Inc N 20181231 42507-955_4c233703-1cb4-4aa5-9dcb-462af0f73745 42507-955 HUMAN OTC DRUG lice treatment Permethrin LOTION TOPICAL 20110122 ANDA ANDA076090 HyVee Inc PERMETHRIN 1 mg/100mL N 20181231 42507-958_8fcc9b73-f5f4-4680-9e35-995e1a2556b2 42507-958 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130708 ANDA ANDA091135 HyVee Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 42507-959_663c32ed-b11f-48b0-8e17-4cb56da51d33 42507-959 HUMAN OTC DRUG Night Time Sleep Aid Diphenhydramine HCl SOLUTION ORAL 20130708 OTC MONOGRAPH FINAL part338 HyVee Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 42507-964_09934f59-9125-4f43-9588-b6283cd2e57c 42507-964 HUMAN OTC DRUG Severe Cold Cough and Flu Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20150302 OTC MONOGRAPH FINAL part341 HyVee Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 42507-966_8ab3d739-b475-49a2-a669-5561cde7da96 42507-966 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080720 ANDA ANDA075077 HyVee Inc ACETAMINOPHEN 650 mg/1 N 20181231 42507-975_5c4e83f1-dbbc-4266-aeab-de553e053695 42507-975 HUMAN OTC DRUG pain relief Acetaminophen TABLET ORAL 19960528 OTC MONOGRAPH NOT FINAL part343 HyVee Inc ACETAMINOPHEN 500 mg/1 N 20181231 42507-987_8108fc43-34c2-45a9-b437-3cf9a8516d4b 42507-987 HUMAN OTC DRUG Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20160412 OTC MONOGRAPH FINAL part341 HyVee Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; 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20150901 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 4.45 g/100g N 20181231 42508-104_f72ac705-582d-4b03-bf7f-ddd372ddd164 42508-104 HUMAN OTC DRUG Clear Future Corrective Treatment SALICYLIC ACID CLOTH TOPICAL 20150401 OTC MONOGRAPH FINAL part333D Arbonne International, LLC SALICYLIC ACID .5 mg/90mL N 20191231 42508-133_89018f20-153e-4018-8ca5-a887de7c906d 42508-133 HUMAN OTC DRUG RE9 Advanced for Men Deluxe Try Me Set Zinc Oxide KIT 20160414 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC N 20181231 42508-134_038124cf-9ea7-44c2-adb4-e50880fc1798 42508-134 HUMAN OTC DRUG FC5 Face Oily Combination Sample Set AVOBENZONE, OCTINOXATE, OCTISALATE, and OCTOCRYLENE KIT 20130401 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC N 20181231 42508-135_63596d2b-a748-4b63-93e7-9315b83b128a 42508-135 HUMAN OTC DRUG FC5 Face Normal to Dry Sample Set Avobenzone, Octinoxate, Octisalate, and Octocrylene KIT 20130401 OTC MONOGRAPH NOT FINAL part352 Arbonne 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20181231 42508-157_316f015d-f4d1-406d-826d-d0b8993cdd1a 42508-157 HUMAN OTC DRUG Perfecting Liquid Foundation Honey Beige SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL N 20181231 42508-158_5eaf05ab-49a9-46ac-9dc1-f1c6b90c6006 42508-158 HUMAN OTC DRUG Perfecting Liquid Foundation Rosy Beige SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL N 20181231 42508-159_4bb5cffc-9abf-40a1-877a-ad7db287ff1f 42508-159 HUMAN OTC DRUG Perfecting Liquid Foundation Neutral Beige SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL N 20181231 42508-160_27c6a513-3f0a-438d-826a-41065684f94c 42508-160 HUMAN OTC DRUG Perfecting Liquid Foundation Soft Blush SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL N 20181231 42508-161_af57971d-4b25-4d9d-bd98-ec451d904261 42508-161 HUMAN OTC DRUG Perfecting Liquid Foundation Toffee Bronze SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL N 20181231 42508-162_38665791-8c72-4d29-a64d-5469de324c8e 42508-162 HUMAN OTC DRUG Perfecting Liquid Foundation Deep Beige SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL N 20181231 42508-163_6e7e332d-1378-47cf-b5b0-bcb03e70f82e 42508-163 HUMAN OTC DRUG Perfecting Liquid Foundation Espresso SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL N 20181231 42508-164_d10b53bd-1b14-4c4a-9ffa-11eb09ef902b 42508-164 HUMAN OTC DRUG Perfecting Liquid Foundation Porcelain SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL N 20181231 42508-165_4f9d8860-2471-49b0-8a18-bbde1b68d905 42508-165 HUMAN OTC DRUG Perfecting Liquid Foundation Buff SPF 15 Zinc Oxide EMULSION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 10 g/100mL N 20181231 42508-196_fcb2edab-f84c-4c1b-b8d3-2010b51a992f 42508-196 HUMAN OTC DRUG ABC Arbonne Baby Care Sample Set DIMETHICONE and ZINC OXIDE KIT 20160415 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC N 20181231 42508-210_b71fa155-b724-427c-aa3e-c9d88b7b41d6 42508-210 HUMAN OTC DRUG Clear Future Intensive Spot Treatment SALICYLIC ACID LOTION TOPICAL 20150401 OTC MONOGRAPH FINAL part333D Arbonne International, LLC SALICYLIC ACID 2 mg/15mL N 20191231 42508-227_36a8d206-7fb5-4b96-a1e0-c24c77f93620 42508-227 HUMAN OTC DRUG FC5 Nurturing Day Broad Spectrum SPF 20 Sunscreen AVOBENZONE, OCTINOXATE, OCTISALATE, and OCTOCRYLENE LOTION TOPICAL 20090321 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; 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SALICYLIC ACID SOLUTION TOPICAL 20090316 OTC MONOGRAPH FINAL part333D Arbonne International, LLC SALICYLIC ACID 10 mg/mL E 20171231 42508-263_d599b368-7f3f-4025-bb27-bb05522a4e2d 42508-263 HUMAN OTC DRUG Arbonne Baby Care Sunscreen SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, and ZINC OXIDE CREAM TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 75; 50; 25; 100 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 42508-265_3acdfdb1-fd03-4cfb-8c36-2c1e880ead57 42508-265 HUMAN OTC DRUG Arbonne RE9 Advanced for Men Facial Moisturizer SPF 20 Octisalate, Octocrylene, and Zinc Oxide LOTION TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC OCTISALATE; OCTOCRYLENE; ZINC OXIDE 50; 80; 73.5 mg/mL; mg/mL; mg/mL E 20171231 42508-283_f81780ed-a12f-4339-9a7e-98d505c1ae73 42508-283 HUMAN OTC DRUG Arbonne Liquid Sunshine SPF15 Zinc Oxide LIPSTICK TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 8 g/100g N 20181231 42508-298_96cc7308-4599-46e7-8778-e3b9ddc6f905 42508-298 HUMAN OTC DRUG Arbonne RE9 Advanced Restorative Day Broad Spectrum SPF 20 AVOBENZONE, HOMOSALATE, OCTINOXATE, and OCTOCRYLENE LOTION TOPICAL 20120713 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 30; 100; 40; 27.5 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 42508-299_ed7bb468-33e5-4fdd-9ab0-5107fe144ea6 42508-299 HUMAN OTC DRUG Arbonne RE9 Advanced Restorative Day Broad Spectrum SPF 20 AVOBENZONE, HOMOSALATE, OCTINOXATE, and OCTOCRYLENE LOTION TOPICAL 20170417 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 30; 100; 40; 27.5 mg/g; mg/g; mg/g; mg/g N 20191231 42508-311_2d5d7a23-d993-4391-870b-7a0ce0f53e15 42508-311 HUMAN OTC DRUG Clear Future Mattifying Treatment SALICYLIC ACID LOTION TOPICAL 20150401 OTC MONOGRAPH FINAL part333D Arbonne International, LLC SALICYLIC ACID .5 mg/50mL N 20191231 42508-338_58be4dc9-0e44-44d2-86c0-3a21a846fe6c 42508-338 HUMAN OTC DRUG Arbonne RE9 Advanced Extra Moisture Restorative Day SPF 20 AVOBENZONE, OCTINOXATE, OCTISALATE, and OCTOCRYLENE LOTION TOPICAL 20140813 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 27.9 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 42508-339_2cbb2ed4-ff59-46fd-b7d7-7af9c4a9d028 42508-339 HUMAN OTC DRUG Arbonne RE9 Advanced Extra Moisture Restorative Day SPF 20 AVOBENZONE, OCTINOXATE, OCTISALATE, and OCTOCRYLENE LOTION TOPICAL 20170417 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 27.9 mg/g; mg/g; mg/g; mg/g N 20191231 42508-364_9199ace7-403d-4f43-a0da-ec89e3f52bf0 42508-364 HUMAN OTC DRUG RE9 Advanced Brightening Sample Pack Zinc Oxide KIT 20170301 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC N 20181231 42508-512_ec5e4ee6-f49f-43ac-8cd9-b9218b59004e 42508-512 HUMAN OTC DRUG ABC Arbonne Baby Care Little Bundles Set Dimethicone and Zinc Oxide KIT 20150901 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC E 20171231 42508-529_d0bbc36d-1442-4a2e-b251-54943388f3d2 42508-529 HUMAN OTC DRUG ABC Arbonne Baby Care Diaper Rash DIMETHICONE and ZINC OXIDE CREAM TOPICAL 20140920 OTC MONOGRAPH FINAL part347 Arbonne International, LLC DIMETHICONE; ZINC OXIDE 1; 12 g/100g; g/100g N 20181231 42508-532_bd1fb77e-b533-4965-a03a-89e6ce7ed4ef 42508-532 HUMAN OTC DRUG ABC Arbonne Baby Care Sunscreen Broad Spectrum SPF 30 ZINC OXIDE LOTION TOPICAL 20140920 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 144 mg/mL N 20181231 42508-538_8aa9dcdf-41e7-476f-b4b9-dd4c2ad46d1f 42508-538 HUMAN OTC DRUG ABC Arbonne Baby Care Kit Dimethicone, Zinc Oxide KIT 20140920 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC N 20181231 42508-904_c28ed863-177e-48c0-a9fc-062b0840f1d8 42508-904 HUMAN OTC DRUG Clear Future Deep Pore Cleanser SALICYLIC ACID GEL TOPICAL 20150401 OTC MONOGRAPH FINAL part333D Arbonne International, LLC SALICYLIC ACID .5 mg/118mL N 20191231 42508-915_64a8e720-0b5d-46d5-9233-f4ba1f6b17c9 42508-915 HUMAN OTC DRUG Liquid Sunshine Mineral Sunscreen Broad Spectrum SPF 30 For Face TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20150416 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC TITANIUM DIOXIDE; ZINC OXIDE 1.7; 4.4 mg/100mL; mg/100mL E 20171231 42508-919_5859690b-563f-41bd-84a4-e8eb4c438ebf 42508-919 HUMAN OTC DRUG Liquid Sunshine Mineral Sunscreen Broad Spectrum SPF 30 For Body ZINC OXIDE LOTION TOPICAL 20150416 OTC MONOGRAPH NOT FINAL part352 Arbonne International, LLC ZINC OXIDE 7.9 mg/100mL E 20171231 42515-001_2b9ca64f-f730-4365-8e73-ff2ce802be4f 42515-001 VACCINE IXIARO Japanese Encephalitis Vaccine, Inactivated, Adsorbed INJECTION, SUSPENSION INTRAMUSCULAR 20090330 BLA BLA125280 Valneva Scotland Ltd. JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) 6 ug/.5mL Inactivated Japanese Encephalitis Virus Vaccine [EPC],Actively Acquired Immunity [PE],Japanese Encephalitis Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] E 20171231 42521-2930_20265376-77ff-42b9-9a76-d8914a12d342 42521-2930 HUMAN OTC DRUG SkinTx UV Pro Broad Spectrum SPF30 ZINC OXIDE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20150514 OTC MONOGRAPH NOT FINAL part352 Dermolab Pharma Ltd ZINC OXIDE; OCTINOXATE; OCTISALATE 99; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 42536-6044_37d71c1d-5fce-44f4-8600-605f5ba7691a 42536-6044 HUMAN PRESCRIPTION DRUG PYtest Urea, C-14 CAPSULE ORAL 19970509 NDA NDA020617 Avent, Inc. UREA C-14 1 uCi/1 E 20171231 42536-6046_d9319e53-c76f-4bd6-a4b2-2c8ad898d9e0 42536-6046 HUMAN PRESCRIPTION DRUG PYtest Urea, C-14 CAPSULE ORAL 19970509 NDA NDA020617 Avent, Inc. UREA C-14 1 uCi/1 E 20171231 42537-024_ff290e74-535d-49cb-9c29-84fcc4f1bfad 42537-024 HUMAN OTC DRUG Qore 24 Antimicrobial Hand Purifier BENZALKONIUM CHLORIDE SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333E Qore Systems LLC BENZALKONIUM CHLORIDE 10 mg/100mL E 20171231 42543-001_d476e851-8cde-4991-8655-da876efab2d9 42543-001 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20150814 ANDA ANDA200981 Vensun Pharmaceuticals, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 42543-002_d476e851-8cde-4991-8655-da876efab2d9 42543-002 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20150814 ANDA ANDA200981 Vensun Pharmaceuticals, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 42543-003_d476e851-8cde-4991-8655-da876efab2d9 42543-003 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20150814 ANDA ANDA200981 Vensun Pharmaceuticals, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 42543-005_e634a0a8-126c-40fe-8ff2-775e9117e79f 42543-005 HUMAN PRESCRIPTION DRUG Sildenafil Citrate Sildenafil TABLET, FILM COATED ORAL 20160801 ANDA ANDA204883 Vensun Pharmaceuticals, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 42543-052_0af97115-4ac5-4db6-8957-1c1c959b23d5 42543-052 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20140901 ANDA ANDA065175 Vensun Pharmaceuticals, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 42543-098_b9fc223c-233b-4438-a666-e4f97c4018d8 42543-098 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 20170622 ANDA ANDA204195 Vensun Pharmaceuticals, Inc. BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 42543-103_1e8cbfd2-88e0-49dd-897d-636bd150743e 42543-103 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20151208 ANDA ANDA205549 Vensun Pharmaceuticals, Inc. POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 42543-104_1e8cbfd2-88e0-49dd-897d-636bd150743e 42543-104 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20151208 ANDA ANDA205549 Vensun Pharmaceuticals, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 42543-114_9f31711c-c863-48ad-aef4-f21a02bf21dc 42543-114 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20170928 ANDA ANDA206136 Vensun Pharmaceuticals, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42543-115_9f31711c-c863-48ad-aef4-f21a02bf21dc 42543-115 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20170928 ANDA ANDA206136 Vensun Pharmaceuticals, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 42543-140_c967c627-ed44-4ae5-ac2c-b3720bc0cd6a 42543-140 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 20170707 ANDA ANDA207029 Vensun Pharmaceuticals, Inc. HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 42543-141_c967c627-ed44-4ae5-ac2c-b3720bc0cd6a 42543-141 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 20170707 ANDA ANDA207029 Vensun Pharmaceuticals, Inc. HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 42543-142_c967c627-ed44-4ae5-ac2c-b3720bc0cd6a 42543-142 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 20170707 ANDA ANDA207029 Vensun Pharmaceuticals, Inc. HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 42543-406_4fb50974-130f-44a6-966b-42649f8b6250 42543-406 HUMAN PRESCRIPTION DRUG POTASSIUM CITRATE EXTENDED RELEASE POTASSIUM CITRATE TABLET ORAL 20170911 ANDA ANDA206813 Vensun Pharmaceuticals Inc POTASSIUM CITRATE 5 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20191231 42543-407_4fb50974-130f-44a6-966b-42649f8b6250 42543-407 HUMAN PRESCRIPTION DRUG POTASSIUM CITRATE EXTENDED RELEASE POTASSIUM CITRATE TABLET ORAL 20170911 ANDA ANDA206813 Vensun Pharmaceuticals Inc POTASSIUM CITRATE 10 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20191231 42543-408_4fb50974-130f-44a6-966b-42649f8b6250 42543-408 HUMAN PRESCRIPTION DRUG POTASSIUM CITRATE EXTENDED RELEASE POTASSIUM CITRATE TABLET ORAL 20170911 ANDA ANDA206813 Vensun Pharmaceuticals Inc POTASSIUM CITRATE 15 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20191231 42543-434_38371f0f-a2e5-4865-a806-8593d25fb500 42543-434 HUMAN PRESCRIPTION DRUG CARISOPRODOL Immediate release CARISOPRODOL TABLET ORAL 20151120 ANDA ANDA205513 Vensun Pharmaceuticals, Inc CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 42543-493_12903478-66b3-4b88-9e2c-c2b2a4f5d6cb 42543-493 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 20160630 ANDA ANDA209047 Vensun Pharmaceuticals, Inc AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 42543-497_6ac9faed-6ab0-4563-9d5b-d7ed817bf017 42543-497 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride TABLET ORAL 20160621 ANDA ANDA209035 Vensun Pharmaceuticals, Inc AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 42543-700_a1d3cfbc-3b90-41cf-9569-5b16e2e5a0fd 42543-700 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20140731 ANDA ANDA203374 Vensun Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 42543-702_a73d19f0-cd8e-4b4a-8ded-b9e028305958 42543-702 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20141210 ANDA ANDA203907 Vensun Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20191231 42543-703_a73d19f0-cd8e-4b4a-8ded-b9e028305958 42543-703 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20141210 ANDA ANDA203907 Vensun Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20191231 42543-704_2d02248a-1880-42e0-af91-528cc77368f5 42543-704 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 Vensun Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 42543-705_2d02248a-1880-42e0-af91-528cc77368f5 42543-705 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 Vensun Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 42543-706_2d02248a-1880-42e0-af91-528cc77368f5 42543-706 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 Vensun Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 42543-707_2d02248a-1880-42e0-af91-528cc77368f5 42543-707 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 Vensun Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 42543-708_2d02248a-1880-42e0-af91-528cc77368f5 42543-708 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 Vensun Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 42543-709_2d02248a-1880-42e0-af91-528cc77368f5 42543-709 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 Vensun Pharmaceuticals, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 42543-712_6c237244-8d76-43f5-ac2d-452aa7194fce 42543-712 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride levocetirizine dihydrochloride TABLET ORAL 20141027 ANDA ANDA203646 Vensun Pharmaceuticals, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 42543-713_0dde0d9b-2546-4688-8d0e-986aac6df327 42543-713 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel TABLET ORAL 20141101 ANDA ANDA204165 Vensun Pharmaceuticals, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 42543-714_0dde0d9b-2546-4688-8d0e-986aac6df327 42543-714 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel TABLET ORAL 20141101 ANDA ANDA204165 Vensun Pharmaceuticals, Inc. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 42543-725_f1764ef9-4324-4e97-a72c-d54bb09245ba 42543-725 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20150316 ANDA ANDA204597 Vensun Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42543-726_f1764ef9-4324-4e97-a72c-d54bb09245ba 42543-726 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20150316 ANDA ANDA204597 Vensun Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42543-727_f1764ef9-4324-4e97-a72c-d54bb09245ba 42543-727 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20150316 ANDA ANDA204597 Vensun Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42545-000_de46eb1d-c637-4caf-a2ce-3d776b06f880 42545-000 HUMAN PRESCRIPTION DRUG OXYGEN, REFRIGERATED OXYGEN GAS RESPIRATORY (INHALATION) 20121128 NDA NDA205889 Dona Ana Medical Supply DBA Silver City Medical Supply OXYGEN 1 L/L E 20171231 42546-010_80ac2838-1814-4afb-8941-9929a861afb6 42546-010 HUMAN OTC DRUG BenzePrO Benzoyl Peroxide AEROSOL, FOAM TOPICAL 20120701 OTC MONOGRAPH FINAL part333D PruGen, Inc. BENZOYL PEROXIDE 3.18 g/60g N 20181231 42546-015_da7c1c63-2a60-427f-98b6-a630c0aae1a5 42546-015 HUMAN OTC DRUG BenzePrO Benzoyl Peroxide AEROSOL, FOAM TOPICAL 20120701 OTC MONOGRAPH FINAL part333D PruGen, Inc. BENZOYL PEROXIDE 9.8 g/100g N 20181231 42546-016_9af4ff36-c2f2-4e1d-bd85-605e8b4004e8 42546-016 HUMAN PRESCRIPTION DRUG BenzePrO Benzoyl Peroxide CLOTH TOPICAL 20150801 UNAPPROVED DRUG OTHER PruGen, Inc. BENZOYL PEROXIDE 60 mg/1 N 20181231 42546-017_7685f00d-5d78-4dcc-a7e2-2de87f3a9b6b 42546-017 HUMAN PRESCRIPTION DRUG BenzePrO Creamy Wash benzoyl peroxide SOAP TOPICAL 20150701 UNAPPROVED DRUG OTHER PruGen, Inc. BENZOYL PEROXIDE 7 g/100g N 20181231 42546-100_2267e100-a474-4423-8f46-3458a9e5e221 42546-100 HUMAN PRESCRIPTION DRUG CEM-Urea urea SOLUTION TOPICAL 20110701 UNAPPROVED DRUG OTHER PruGen, Inc. UREA .45 mL/mL E 20171231 42546-145_d39d0431-ad77-4970-9ecf-359cbe234ed9 42546-145 HUMAN PRESCRIPTION DRUG PR Benzoyl Peroxide Wash Benzoyl Peroxide Wash LOTION TOPICAL 20091026 UNAPPROVED DRUG OTHER PruGen, Inc. BENZOYL PEROXIDE 70 mg/mL N 20181231 42546-175_1e652f39-81d7-4ee0-ba28-de36caa001fa 42546-175 HUMAN PRESCRIPTION DRUG SulfaCleanse 8/4 sodium sulfacetamide and sulfur LOTION TOPICAL 20110501 UNAPPROVED DRUG OTHER PruGen, Inc. SULFACETAMIDE SODIUM; SULFUR 80; 40 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 42546-180_6c9669f5-7c92-4af0-966a-f4f825fe89ab 42546-180 HUMAN PRESCRIPTION DRUG Bal-Care DHA BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, SODIUM FEREDETATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IRON SUCROSE, IODINE, OMEGA 3 FATTY ACIDS KIT 20120501 UNAPPROVED DRUG OTHER PruGen, Inc. E 20171231 42546-185_2c323451-ca19-4f26-aa1f-c281f53bc8e4 42546-185 HUMAN PRESCRIPTION DRUG Bal-Care DHA Essential BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, SODIUM FEREDETATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IRON SUCROSE, IODINE, OMEGA 3 FATTY ACIDS KIT 20120501 UNAPPROVED DRUG OTHER PruGen, Inc. E 20171231 42546-190_1ace1b62-3565-4486-ac54-94a2a1b74554 42546-190 HUMAN PRESCRIPTION DRUG Moms Choice Rx BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, SODIUM FEREDETATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IRON SUCROSE, IODINE, OMEGA 3 FATTY ACIDS KIT 20130401 UNAPPROVED DRUG OTHER PruGen, Inc. E 20171231 42546-270_f746bae8-eac3-4134-aac2-95c9e7c790f1 42546-270 HUMAN PRESCRIPTION DRUG Salicylic Acid salicylic acid CREAM TOPICAL 20110501 UNAPPROVED DRUG OTHER PruGen, Inc. SALICYLIC ACID 27.24 g/g E 20171231 42546-279_c8a04175-683c-4370-9734-dd0a0abd28f2 42546-279 HUMAN PRESCRIPTION DRUG Salicylic Acid 6 percent Salicylic Acid SHAMPOO TOPICAL 20090101 UNAPPROVED DRUG OTHER PruGen, Inc. SALICYLIC ACID 6 mg/100mL N 20191231 42546-300_3a11164d-6eb1-4a01-8722-0086f94a85b3 42546-300 HUMAN PRESCRIPTION DRUG Zingiber pyridoxine, folic acid, calcium, and ginger tablet TABLET ORAL 20130201 UNAPPROVED DRUG OTHER PruGen, Inc. Pharmaceuticals PYRIDOXINE; FOLIC ACID; CALCIUM; GINGER 40; 1.2; 124.1; 100 mg/1; mg/1; mg/1; mg/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 42546-517_00736fdd-192f-4ef9-9abe-c5c0d2f8cef2 42546-517 HUMAN PRESCRIPTION DRUG PR Natal 400 ec beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron protein succinylate, ferrous bisglycinate, magnesium oxide, zinc oxide, cupric oxide tablet KIT 20100101 UNAPPROVED DRUG OTHER PruGen, Inc Pharmaceuticals E 20171231 42546-518_9e43a416-3601-44e3-be7f-9132594aedaa 42546-518 HUMAN PRESCRIPTION DRUG PR Natal 430 ec beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron protein succinylate, ferrous bisglycinate, magnesium oxide, zinc oxide, cupric oxide tablet KIT 20100101 UNAPPROVED DRUG OTHER PruGen, Inc Pharmaceuticals E 20171231 42546-700_e8f3ea4a-435c-4869-9fb0-4ac62cbbd049 42546-700 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20060718 ANDA ANDA077819 Prugen, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 42546-720_8ba7e13b-3c62-4726-adea-8da242edbded 42546-720 HUMAN PRESCRIPTION DRUG Adapalene Adapalene GEL TOPICAL 20160304 ANDA ANDA091314 PruGen, Inc. ADAPALENE 45 g/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 42546-771_448e42c6-378a-418c-a46f-60b85c83ce8c 42546-771 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA202261 PruGen Pharmaceuticals MINOCYCLINE HYDROCHLORIDE 45 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 42546-774_448e42c6-378a-418c-a46f-60b85c83ce8c 42546-774 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA202261 PruGen Pharmaceuticals MINOCYCLINE HYDROCHLORIDE 90 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 42546-777_448e42c6-378a-418c-a46f-60b85c83ce8c 42546-777 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA202261 PruGen Pharmaceuticals MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 42546-811_41935853-a3f1-42ff-8ce8-8d34257d8d87 42546-811 HUMAN PRESCRIPTION DRUG PR Natal 400 beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron protein succinylate, ferrous bisglycinate, magnesium oxide, zinc oxide, cupric oxide tablet KIT 20100101 UNAPPROVED DRUG OTHER PruGen, Inc Pharmaceuticals E 20171231 42546-812_38df8e18-1046-48cf-9965-2d574e3269e3 42546-812 HUMAN PRESCRIPTION DRUG PR Natal 430 beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron protein succinylate, ferrous bisglycinate, magnesium oxide, zinc oxide, cupric oxide tablet KIT 20100101 UNAPPROVED DRUG OTHER PruGen, Inc Pharmaceuticals E 20171231 42549-514_fe5ba386-ea2e-4884-9ce7-f00f71d4c101 42549-514 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040400 STAT Rx USA LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42549-556_fe5ba386-ea2e-4884-9ce7-f00f71d4c101 42549-556 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040409 STAT Rx USA LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42549-557_fe5ba386-ea2e-4884-9ce7-f00f71d4c101 42549-557 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040405 STAT Rx USA LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 42555-060_46e3a5c9-da0e-494a-a9d7-2f8a7cdffda5 42555-060 HUMAN OTC DRUG Colgate Anticavity SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20090604 OTC MONOGRAPH FINAL part355 COLGATE-PALMOLIVE (THAILAND) LIMITED SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20191231 42571-005_5e8bc71c-9159-95dc-e053-2a91aa0aba0f 42571-005 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20130613 ANDA ANDA090383 Micro Labs Limited SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42571-010_5e8bc71c-9159-95dc-e053-2a91aa0aba0f 42571-010 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20130613 ANDA ANDA090383 Micro Labs Limited SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42571-020_5e8bc71c-9159-95dc-e053-2a91aa0aba0f 42571-020 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20130613 ANDA ANDA090383 Micro Labs Limited SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42571-040_5e8bc71c-9159-95dc-e053-2a91aa0aba0f 42571-040 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20130613 ANDA ANDA090383 Micro Labs Limited SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42571-080_5e8bc71c-9159-95dc-e053-2a91aa0aba0f 42571-080 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20130613 ANDA ANDA090383 Micro Labs Limited SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42571-100_4529ac93-bceb-27fe-e054-00144ff88e88 42571-100 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Micro Labs Limited GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 42571-101_4529ac93-bceb-27fe-e054-00144ff88e88 42571-101 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Micro Labs Limited GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 42571-102_4529ac93-bceb-27fe-e054-00144ff88e88 42571-102 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Micro Labs Limited GLIMEPIRIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 42571-103_4529ac93-bceb-27fe-e054-00144ff88e88 42571-103 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Micro Labs Limited GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 42571-104_4529ac93-bceb-27fe-e054-00144ff88e88 42571-104 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Micro Labs Limited GLIMEPIRIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 42571-105_4529ac93-bceb-27fe-e054-00144ff88e88 42571-105 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20130613 ANDA ANDA091220 Micro Labs Limited GLIMEPIRIDE 8 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 42571-110_4ab233c0-9c4b-6ea7-e054-00144ff88e88 42571-110 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM losartan potassium TABLET, FILM COATED ORAL 20121206 ANDA ANDA091541 Micro Labs Limited LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42571-111_4ab233c0-9c4b-6ea7-e054-00144ff88e88 42571-111 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM losartan potassium TABLET, FILM COATED ORAL 20121206 ANDA ANDA091541 Micro Labs Limited LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42571-112_4ab233c0-9c4b-6ea7-e054-00144ff88e88 42571-112 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM losartan potassium TABLET, FILM COATED ORAL 20121206 ANDA ANDA091541 Micro Labs Limited LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42571-119_5a2b5034-88a6-b295-e053-2a91aa0a71c1 42571-119 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED ORAL 20121215 ANDA ANDA201952 Micro Labs Limited TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 42571-122_5e8d42ca-30d3-60a9-e053-2a91aa0a85c0 42571-122 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20130930 ANDA ANDA202046 Micro Labs Limited LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 42571-131_56758a5d-1ad4-741d-e054-00144ff88e88 42571-131 HUMAN PRESCRIPTION DRUG NEVIRAPINE NEVIRAPINE TABLET ORAL 20120522 ANDA ANDA203080 Micro Labs Limited NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 42571-132_41e2fe3e-bc51-0762-e054-00144ff88e88 42571-132 HUMAN PRESCRIPTION DRUG CROMOLYN SODIUM Cromolyn sodium SOLUTION, CONCENTRATE ORAL 20130504 ANDA ANDA202745 Micro Labs Limited CROMOLYN SODIUM 100 mg/5mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 42571-160_58bb4c7f-ffa3-6279-e053-2a91aa0a6a86 42571-160 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20170301 ANDA ANDA205707 Micro Labs Limited AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 42571-161_58bb4c7f-ffa3-6279-e053-2a91aa0a6a86 42571-161 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20170301 ANDA ANDA205707 Micro Labs Limited AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 42571-162_58bb4c7f-ffa3-6279-e053-2a91aa0a6a86 42571-162 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20170301 ANDA ANDA204755 Micro Labs Limited AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 42571-189_5f821e4b-29eb-ba43-e053-2991aa0a187a 42571-189 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION INTRAVENOUS 20170801 ANDA ANDA206713 Micro Labs Limited TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 42571-226_5ea067fc-7eaf-20e7-e053-2991aa0a6a5b 42571-226 HUMAN PRESCRIPTION DRUG TELMISARTAN Telmisartan TABLET ORAL 20180101 ANDA ANDA207016 Micro Labs Limited TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42571-227_5ea067fc-7eaf-20e7-e053-2991aa0a6a5b 42571-227 HUMAN PRESCRIPTION DRUG TELMISARTAN Telmisartan TABLET ORAL 20180101 ANDA ANDA207016 Micro Labs Limited TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42571-228_5ea067fc-7eaf-20e7-e053-2991aa0a6a5b 42571-228 HUMAN PRESCRIPTION DRUG TELMISARTAN Telmisartan TABLET ORAL 20180101 ANDA ANDA207016 Micro Labs Limited TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42571-235_5d4ba544-5b8b-1c42-e053-2991aa0a6c91 42571-235 HUMAN PRESCRIPTION DRUG AMLODIPINE AND OLMESARTAN MEDOXOMIL Amlodipine and Olmesartan Medoxomil TABLET ORAL 20180101 ANDA ANDA207435 Micro Labs Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42571-236_5d4ba544-5b8b-1c42-e053-2991aa0a6c91 42571-236 HUMAN PRESCRIPTION DRUG AMLODIPINE AND OLMESARTAN MEDOXOMIL Amlodipine and Olmesartan Medoxomil TABLET ORAL 20180101 ANDA ANDA207435 Micro Labs Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42571-237_5d4ba544-5b8b-1c42-e053-2991aa0a6c91 42571-237 HUMAN PRESCRIPTION DRUG AMLODIPINE AND OLMESARTAN MEDOXOMIL Amlodipine and Olmesartan Medoxomil TABLET ORAL 20180101 ANDA ANDA207435 Micro Labs Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42571-238_5d4ba544-5b8b-1c42-e053-2991aa0a6c91 42571-238 HUMAN PRESCRIPTION DRUG AMLODIPINE AND OLMESARTAN MEDOXOMIL Amlodipine and Olmesartan Medoxomil TABLET ORAL 20180101 ANDA ANDA207435 Micro Labs Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42571-244_60aa4a89-2752-4c81-e053-2a91aa0a304f 42571-244 HUMAN PRESCRIPTION DRUG CAFFEINE CITRATE Caffeine Citrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171230 ANDA ANDA207400 Micro Labs Limited CAFFEINE CITRATE 60 mg/3mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 42571-258_5c950c0b-56a9-59f0-e053-2a91aa0aca85 42571-258 HUMAN PRESCRIPTION DRUG Mefenamic acid Mefenamic acid CAPSULE ORAL 20101119 ANDA ANDA090562 Micro Labs Limited MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42571-265_6483ec70-956c-1cb8-e053-2a91aa0a975c 42571-265 HUMAN PRESCRIPTION DRUG SODIUM NITROPRUSSIDE sodium nitroprusside INJECTION INTRAVENOUS 20171230 ANDA ANDA209352 Micro Labs Limited SODIUM NITROPRUSSIDE 50 mg/2mL Vasodilation [PE],Vasodilator [EPC] N 20191231 42576-180_9a6f7c98-8459-40a6-99c2-03a990ae69d2 42576-180 HUMAN OTC DRUG POLYETHYLENE GLYCOL 3350 NF polyethylene glycol 3350 POWDER, FOR SOLUTION ORAL 20170703 ANDA ANDA206105 NUVO PHARMACEUTICAL INC. POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 42582-100_44838a95-745c-4ee2-8361-e3fd9f3de1de 42582-100 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Bi-Coastal Pharmaceutical Corporation ISOXSUPRINE HYDROCHLORIDE 10 mg/1 E 20171231 42582-101_881994e0-3c9f-4a80-849d-ad3f46f59ca8 42582-101 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride TABLET ORAL 20110602 UNAPPROVED DRUG OTHER BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY ISOXSUPRINE HYDROCHLORIDE 10 mg/1 E 20171231 42582-111_05d99583-4696-4820-bc05-ed708b6049c1 42582-111 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20160414 ANDA ANDA090796 Bi-Coastal Pharma International LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42582-112_05d99583-4696-4820-bc05-ed708b6049c1 42582-112 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20160414 ANDA ANDA090796 Bi-Coastal Pharma International LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42582-113_05d99583-4696-4820-bc05-ed708b6049c1 42582-113 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20160414 ANDA ANDA090796 Bi-Coastal Pharma International LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42582-114_2623362f-c5cd-4880-bb49-2d64bedf7be0 42582-114 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160413 ANDA ANDA090007 Bi-Coastal Pharma International LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 42582-115_2623362f-c5cd-4880-bb49-2d64bedf7be0 42582-115 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160413 ANDA ANDA090007 Bi-Coastal Pharma International LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 42582-116_2623362f-c5cd-4880-bb49-2d64bedf7be0 42582-116 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160413 ANDA ANDA090007 Bi-Coastal Pharma International LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 42582-200_44838a95-745c-4ee2-8361-e3fd9f3de1de 42582-200 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Bi-Coastal Pharmaceutical Corporation ISOXSUPRINE HYDROCHLORIDE 20 mg/1 E 20171231 42582-201_881994e0-3c9f-4a80-849d-ad3f46f59ca8 42582-201 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride TABLET ORAL 20110602 UNAPPROVED DRUG OTHER BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY ISOXSUPRINE HYDROCHLORIDE 20 mg/1 N 20181231 42582-211_ef13c171-36a2-4607-9edf-281950a60381 42582-211 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20160201 ANDA ANDA062713 Bi-Coastal Pharma International LLC CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 42582-212_ef13c171-36a2-4607-9edf-281950a60381 42582-212 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20160201 ANDA ANDA062713 Bi-Coastal Pharma International LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 42582-213_a4168d48-e412-463e-b25c-c6c99224d1bc 42582-213 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20160201 ANDA ANDA062058 Bi-Coastal Pharma International LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 42582-214_a4168d48-e412-463e-b25c-c6c99224d1bc 42582-214 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20160201 ANDA ANDA062058 Bi-Coastal Pharma International LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 42582-300_6b280638-de5a-41f5-8005-86cb00187c81 42582-300 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20110504 UNAPPROVED DRUG OTHER Bi-Coastal Pharmaceutical Corporation CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] E 20171231 42582-301_fc07374a-01f7-465e-a3b5-3d7c8a35a511 42582-301 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20110504 UNAPPROVED DRUG OTHER BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] E 20171231 42582-311_c90c873d-f6a2-4093-ad15-7138144586c6 42582-311 HUMAN PRESCRIPTION DRUG Donepezil Hyrochloride 5mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20150701 ANDA ANDA090551 Bi-Coastal Pharma International LLC DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 42582-312_c90c873d-f6a2-4093-ad15-7138144586c6 42582-312 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride 10mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20150701 ANDA ANDA090551 Bi-Coastal Pharma International LLC DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 42582-313_76300e60-c63b-4682-9388-09fe9244a19b 42582-313 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE 2.5 mg AMLODIPINE BESYLATE TABLET ORAL 20161005 ANDA ANDA077516 Bi-Coastal Pharma International LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 42582-314_76300e60-c63b-4682-9388-09fe9244a19b 42582-314 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE 5 mg AMLODIPINE BESYLATE TABLET ORAL 20161005 ANDA ANDA077516 Bi-Coastal Pharma International LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 42582-315_76300e60-c63b-4682-9388-09fe9244a19b 42582-315 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE 10 mg AMLODIPINE BESYLATE TABLET ORAL 20161005 ANDA ANDA077516 Bi-Coastal Pharma International LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 42582-500_2707dae1-fb73-469a-a4ce-7eb8cddf7f60 42582-500 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium and Sulfur SULFACETAMIDE SODIUM and SULFUR CREAM TOPICAL 20110601 UNAPPROVED DRUG OTHER Bi-Coastal Pharma International LLC SULFACETAMIDE SODIUM; SULFUR 90; 45 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 42582-600_61e66aa3-40d7-4c6c-b54f-c250e2e944b5 42582-600 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium and Sulfur SULFACETAMIDE SODIUM and SULFUR CREAM TOPICAL 20110101 UNAPPROVED DRUG OTHER Bi-Coastal Pharma International LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 42582-700_20a40680-2a75-4a8c-bc5d-172eabfe1b59 42582-700 HUMAN PRESCRIPTION DRUG Hydroquinone Hydroquinone CREAM TOPICAL 20110715 UNAPPROVED DRUG OTHER Bi-Coastal Pharma International LLC HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] E 20171231 42582-800_f72238f4-cbb9-4478-87b9-a9f63be61b08 42582-800 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide and Sulfur Cleanser SULFACETAMIDE SODIUM and SULFUR CREAM TOPICAL 20110601 UNAPPROVED DRUG OTHER Bi-Coastal Pharma International LLC SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 42582-801_b94d8453-4353-414e-819b-4c05885c4489 42582-801 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 9.8%, Sulfur 4.8% Sodium Sulfacetamide, Sulfur SOLUTION TOPICAL 20170327 UNAPPROVED DRUG OTHER Bi-Coastal Pharma International LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 42582-900_6598c536-29e4-49e0-9cf8-a77eddebd6ac 42582-900 HUMAN PRESCRIPTION DRUG Selenium Sulfide Selenium Sulfide SHAMPOO TOPICAL 20110601 UNAPPROVED DRUG OTHER Bi-Coastal Pharma International LLC SELENIUM SULFIDE 22.5 mg/mL N 20181231 42584-1001_8cda7c29-c302-4dbd-a705-814b8fb8b092 42584-1001 HUMAN OTC DRUG HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20120214 OTC MONOGRAPH NOT FINAL part333E HOME DEPOT U.S.A. INC. ALCOHOL 62 mL/100mL E 20171231 42587-001_7c5132ea-889c-4813-ae70-6411961dad84 42587-001 HUMAN OTC DRUG Frais Hand Sanitizer ALCOHOL GEL TOPICAL 20080515 OTC MONOGRAPH FINAL part333 Frais Luxury Products ALCOHOL 66 g/100g E 20171231 42589-001_d5802176-70bc-4b92-b6af-631d505553cb 42589-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Med-Tech Repairs Inc OXYGEN 99 L/100L E 20171231 42593-001_fd722a6c-7461-4256-9d67-0e68e9f11d40 42593-001 HUMAN OTC DRUG Barielle Professional Maximum Strength Fungus Rx Antifungal PRO TOLNAFTATE SOLUTION TOPICAL 20120101 OTC MONOGRAPH FINAL part333C Fisk Industries TOLNAFTATE 1 mL/100mL E 20171231 42593-002_c0963865-9260-41f4-809b-1c16b0cda4bc 42593-002 HUMAN OTC DRUG Barielle Fungus Rx Maximum Strength Anti-Fungal TOLNAFTATE SOLUTION TOPICAL 20120101 OTC MONOGRAPH FINAL part333C Fisk Industries TOLNAFTATE 1 mL/100mL E 20171231 42602-001_d5fd4098-990f-4161-bb5f-baf6da194de3 42602-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20080901 NDA NDA205820 Norco, Inc. OXYGEN 999 L/1000L N 20181231 42602-002_39bd1938-f366-4d32-912e-acb41b6d2423 42602-002 HUMAN PRESCRIPTION DRUG HELIUM HELIUM GAS RESPIRATORY (INHALATION) 20080901 NDA NDA205819 Norco, Inc. HELIUM 99 L/100L N 20181231 42602-003_0771f6da-e8e3-4a5e-96d3-38deb7cc1fcf 42602-003 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 20080901 NDA NDA206009 Norco, Inc NITROUS OXIDE 99 L/100L N 20181231 42602-004_99719ba1-5b99-4f1d-92e2-db49178013ee 42602-004 HUMAN PRESCRIPTION DRUG MEDICAL AIR OXYGEN GAS RESPIRATORY (INHALATION) 20080901 NDA NDA205820 Norco, Inc. OXYGEN 23 L/100L N 20181231 42602-005_0d4993d6-6f39-4ec6-a2c5-70ff435c3ccd 42602-005 HUMAN PRESCRIPTION DRUG NITROGEN NF NITROGEN GAS RESPIRATORY (INHALATION) 20030227 NDA NDA205805 Norco, Inc NITROGEN 999 L/1000L N 20181231 42602-006_745c7989-2544-486d-8068-8d1eeeb0cf8a 42602-006 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 20080901 NDA NDA205764 Norco, Inc CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 42602-007_84f8e177-0959-4346-9a7c-b7dec7fc4c6e 42602-007 HUMAN PRESCRIPTION DRUG COMPRESSED GAS, N.O.S. OXYGEN, HELIUM GAS RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS Norco, Inc. OXYGEN; HELIUM 20.4; 79.6 L/100L; L/100L N 20181231 42602-008_9d9efcb2-5df5-47b7-8bc8-88ff92bb5791 42602-008 HUMAN PRESCRIPTION DRUG COMPRESSED GAS OXIDIZING, N.O.S. OXYGEN, HELIUM GAS RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS Norco, Inc. OXYGEN; HELIUM 30; 70 L/100L; L/100L N 20181231 42606-004_499fd880-257d-49d2-972f-68be99d6e5cd 42606-004 CELLULAR THERAPY GINTUIT Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen CELLULAR SHEET TOPICAL 20120315 BLA BLA125400 Organogenesis, Inc FORESKIN FIBROBLAST (NEONATAL); BOVINE TYPE I COLLAGEN; FORESKIN KERATINOCYTE (NEONATAL) /; /; / Allogeneic Cultured Cell Scaffold [EPC],Collagen [Chemical/Ingredient],Allogeneic Cultured Cell Scaffold [EPC],Tissue Scaffolds [Chemical/Ingredient],Cells, Cultured, Allogeneic [Chemical/Ingredient],Fibroblasts [Chemical/Ingredient],Allogeneic Cultured Cell Scaffold [EPC],Tissue Scaffolds [Chemical/Ingredient],Cells, Cultured, Allogeneic [Chemical/Ingredient],Keratinocytes [Chemical/Ingredient] E 20171231 42608-0006_63eac4a3-37c0-d797-e053-2a91aa0aaa67 42608-0006 HUMAN PRESCRIPTION DRUG Paricalcitol paricalcitol CAPSULE, GELATIN COATED ORAL 20151103 ANDA ANDA202124 Catalent U.K. Packaging Limited PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20191231 42627-201_ff582c1c-f414-4f0b-9da2-7fea197f4a4c 42627-201 HUMAN OTC DRUG Veil Fluid Makeup Porcelain SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 42627-202_54fb00ef-597f-47de-a47a-8f0cb9c227e1 42627-202 HUMAN OTC DRUG Veil Fluid Makeup Ivory SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 42627-202_c9151318-32e8-4193-96e3-39ec4858c923 42627-202 HUMAN OTC DRUG Veil Fluid Makeup Ivory SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 42627-203_80ca407e-44de-4ed5-826d-32217a1f4e05 42627-203 HUMAN OTC DRUG Veil Fluid Makeup Nude SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 42627-204_f4cd3b42-9afd-4355-a64c-892cfbd0cf9c 42627-204 HUMAN OTC DRUG Veil Fluid Makeup Light Beige SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 42627-205_8cc5bfab-cb60-40b3-8171-5b580005980b 42627-205 HUMAN OTC DRUG Veil Fluid Makeup Honey SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 42627-206_5acf34f1-8b2c-4fcc-be19-ce354a5c6462 42627-206 HUMAN OTC DRUG Veil Fluid Makeup Sand SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 42627-207_73e06df1-7c25-49d2-a7eb-be189d9c8434 42627-207 HUMAN OTC DRUG Veil Fluid Makeup Beige SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 42627-208_49debbee-5e99-4011-a856-93969333b1c0 42627-208 HUMAN OTC DRUG Veil Fluid Makeup Warm Beige SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 42627-209_61058731-7456-4dc0-9cee-70d0ff61deb9 42627-209 HUMAN OTC DRUG Veil Fluid Makeup Sable SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 42627-210_068973e3-29f2-49c4-817a-fea31cf971b7 42627-210 HUMAN OTC DRUG Veil Fluid Makeup Chestnut SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 42627-211_9144fc0c-4298-4e90-902a-cf714623f3fe 42627-211 HUMAN OTC DRUG Veil Fluid Makeup Walnut SPF 15 Octinoxate, Octisalate, Oxybenzone EMULSION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC. DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 42627-229_c92c3642-623d-4f95-81b9-dde83c82d7d7 42627-229 HUMAN OTC DRUG Veil Mineral Primer SPF 15 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC, DBA Hourglass Cosmetics ZINC OXIDE; TITANIUM DIOXIDE 4.2; 2.45 g/mL; g/mL N 20181231 42627-254_727828f4-5c2c-4732-a465-c715bc6b18d8 42627-254 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Shell SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL N 20181231 42627-255_c8c1812f-e9a9-4518-b28a-212420ff96d1 42627-255 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Ivory SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL N 20181231 42627-256_4e099aa7-3b77-4de6-b783-ca30540b8ee0 42627-256 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Light Beige SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL N 20181231 42627-257_7c055429-e28c-4815-bb3e-0f40f8c344a4 42627-257 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Sand SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL N 20181231 42627-258_dcf45f77-3b42-4244-ae1f-b0d53a83a231 42627-258 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Beige SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL N 20181231 42627-259_6e72d1d7-1780-46c1-a02b-dfc6720c0e9b 42627-259 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Sable SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL N 20181231 42627-260_525cdd46-0e74-4497-8e79-985ec9d7f107 42627-260 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Nude SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL N 20181231 42627-261_5f69abc9-208b-49c8-9a69-8a8d429e2f54 42627-261 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Warm Ivory SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL N 20181231 42627-262_8ed48ab2-3d10-4485-9aef-d20850cdfd14 42627-262 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Vanilla SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL N 20181231 42627-263_83e778e5-ddbb-49b0-b1ca-394100d0d933 42627-263 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Honey SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL N 20181231 42627-264_1f19ea1d-2024-454f-9f9f-63096f6e8023 42627-264 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Golden SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL N 20181231 42627-265_6bee0bb4-fa47-447e-9550-5215e107b831 42627-265 HUMAN OTC DRUG Illusion Tinted Moisturizer Broad Spectrum Golden Tan SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE EMULSION TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC DBA Hourglass Cosmetics OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4; 4 g/100mL; g/100mL; g/100mL N 20181231 42627-269_be2af76c-3a9b-41f3-ab6c-41789ccaab44 42627-269 HUMAN OTC DRUG Hourglass Equilibrium Day Fluid SPF 30 Homosalate, Octinoxate, Ocitsalate, Avobenzone LOTION TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part352 Kingdom Animalia, LLC dba Hourglass Comsetics HOMOSALATE; OCTINOXATE; OCTISALATE; AVOBENZONE 9.9; 7.5; 3; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 42637-803_f490b8eb-5aac-4308-9d5a-f41bb7b197ea 42637-803 HUMAN OTC DRUG Olbas Lozenges Maximun Strength Menthol LOZENGE ORAL 20100405 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Limited MENTHOL 10 mg/1 E 20171231 42637-810_9260dc0a-cc65-46e1-b8f4-d959928c7d04 42637-810 HUMAN OTC DRUG Throat and Chest Anise and Menthol Menthol LOZENGE ORAL 20110713 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Limited MENTHOL 5 mg/1 E 20171231 42637-813_bf1fdce9-c418-4917-820b-f65776a03c51 42637-813 HUMAN OTC DRUG Throat and Chest Honey Lemon and Menthol Menthol LOZENGE ORAL 20110713 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Limited MENTHOL 5 mg/1 E 20171231 42637-819_c3783aee-0021-4f41-9176-ed8a09697263 42637-819 HUMAN OTC DRUG Throat and Chest Berry Menthol Menthol LOZENGE ORAL 20110713 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Limited MENTHOL 5 mg/1 E 20171231 42637-820_6e3c8775-6887-4f71-aac1-2ae0811d8d63 42637-820 HUMAN OTC DRUG Throat and Chest Chili and Lime Menthol LOZENGE ORAL 20110713 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Limited MENTHOL 5 mg/1 E 20171231 42637-821_1bf021d2-bb0d-4b4d-9b95-7bcbea5ed28f 42637-821 HUMAN OTC DRUG Jakemans Blueberry Menthol LOZENGE ORAL 20140101 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Ltd. MENTHOL 5 mg/100mg N 20181231 42637-822_8989d9b2-1e4a-4b5a-b598-f56312767d7f 42637-822 HUMAN OTC DRUG Jakemans Cherry Menthol LOZENGE ORAL 20131209 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Ltd. MENTHOL 5 mg/1 N 20181231 42637-823_94c66b42-0f88-499b-938a-6c6a3c036d4a 42637-823 HUMAN OTC DRUG Jakemans Peppermint Menthol LOZENGE ORAL 20131211 OTC MONOGRAPH FINAL part341 Jakemans (Confectioners) Ltd. MENTHOL 5 mg/1 N 20181231 42638-7663_9a75311e-6f33-4772-878f-d50b2372a21f 42638-7663 HUMAN OTC DRUG NicFix Nicotine LIQUID ORAL 20140109 UNAPPROVED HOMEOPATHIC Nico Worldwide, Inc. NICOTINE; TYROSINE; PHENYLALANINE; TRYPTOPHAN; CAFFEINE; CITRIC ACID MONOHYDRATE 3; 30; 30; 40; 115; 45 mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg E 20171231 42638-7664_620e053b-22c4-422b-b16a-3093e0601f6e 42638-7664 HUMAN OTC DRUG NicFix Plus Nicotine LIQUID ORAL 20140109 UNAPPROVED HOMEOPATHIC Nico Worldwide, Inc. NICOTINE; TYROSINE; PHENYLALANINE; CAFFEINE; CITRIC ACID MONOHYDRATE 3; 30; 30; 75; 45 mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg; mg/60000mg E 20171231 42638-7666_f7620aec-84a9-4c2d-aeb3-1a68c05fe615 42638-7666 HUMAN OTC DRUG Mycratine Migraine Relief Mycratine Migraine Relief LIQUID ORAL 20130615 UNAPPROVED HOMEOPATHIC Nico Worldwide, Inc. NICOTINE; TYROSINE; PHENYLALANINE; TRYPTOPHAN; CAFFEINE 6; 30; 20; 40; 85 [hp_X]/60mL; mg/60mL; mg/60mL; mg/60mL; mg/60mL E 20171231 42643-101_455881bc-4c62-4439-b7dc-ce2a80bb9142 42643-101 HUMAN OTC DRUG BABY DIAPER ZINC OXIDE CREAM TOPICAL 20130101 OTC MONOGRAPH FINAL part347 TELLURIAN ZINC OXIDE 10 g/10g E 20171231 42654-001_9b89666b-ca39-45fd-91f9-05a0a9ec391e 42654-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS Prescription Oxygen Service OXYGEN 99 L/100L E 20171231 42657-111_d7589450-bec8-4796-bc91-aa096017870e 42657-111 HUMAN OTC DRUG SkinDog Avobenzone,Octocrylene,Oxybenzone,Homosalate,Octisalate LOTION TOPICAL 20120105 OTC MONOGRAPH FINAL part352 SkinDog, LLC AVOBENZONE; HOMOSALATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE 1.7; 8.5; 3.4; 2.8; 2.27 g/56.7g; g/56.7g; g/56.7g; g/56.7g; g/56.7g E 20171231 42658-007_6a7ddc81-d6b3-420c-911a-17d0d9a6229a 42658-007 HUMAN PRESCRIPTION DRUG Daunorubicin Hydrochloride daunorubicin hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20161001 UNAPPROVED DRUG OTHER Halison Pharmaceuiticals USA, Inc DAUNORUBICIN HYDROCHLORIDE 20 mg/4mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 42658-101_5e7f569b-41d5-2c5a-e053-2a91aa0ad76a 42658-101 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET, FILM COATED ORAL 20171116 ANDA ANDA204076 Hisun Pharmaceuticals USA, Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 42658-108_5e149e75-fdbe-a512-e053-2a91aa0a1b6b 42658-108 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20171113 ANDA ANDA206557 Hisun Pharmaceuticals USA, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42658-109_5e149e75-fdbe-a512-e053-2a91aa0a1b6b 42658-109 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20171113 ANDA ANDA206557 Hisun Pharmaceuticals USA, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42658-110_5e149e75-fdbe-a512-e053-2a91aa0a1b6b 42658-110 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20171113 ANDA ANDA206557 Hisun Pharmaceuticals USA, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42658-111_5e149e75-fdbe-a512-e053-2a91aa0a1b6b 42658-111 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20171113 ANDA ANDA206557 Hisun Pharmaceuticals USA, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 42658-121_35c0e2f7-e6ec-0971-e054-00144ff88e88 42658-121 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET, FILM COATED ORAL 20160614 ANDA ANDA206194 Hisun Pharmaceuticals USA Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42658-122_35c0e2f7-e6ec-0971-e054-00144ff88e88 42658-122 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET, FILM COATED ORAL 20160614 ANDA ANDA206194 Hisun Pharmaceuticals USA Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42658-123_35c0e2f7-e6ec-0971-e054-00144ff88e88 42658-123 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET, FILM COATED ORAL 20160614 ANDA ANDA206194 Hisun Pharmaceuticals USA Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 42658-130_4bfe8f50-d498-0c80-e054-00144ff8d46c 42658-130 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET ORAL 20170324 ANDA ANDA202410 Hisun Pharmaceuticals USA, Inc. DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 42658-141_3f08eeda-dbc2-0db5-e054-00144ff88e88 42658-141 HUMAN PRESCRIPTION DRUG IRBESARTAN AND HYDROCHLOROTHIAZIDE irbesartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20161014 ANDA ANDA207896 Hisun Pharmaceuticals USA Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 42658-142_3f08eeda-dbc2-0db5-e054-00144ff88e88 42658-142 HUMAN PRESCRIPTION DRUG IRBESARTAN AND HYDROCHLOROTHIAZIDE irbesartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20161014 ANDA ANDA207896 Hisun Pharmaceuticals USA Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 42658-501_5f16c773-e2f8-2d5b-e053-2a91aa0a5493 42658-501 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20171113 ANDA ANDA204077 Hisun Pharmaceuticals USA, Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 42659-011_1b66556d-4923-4a36-baee-91fb68be4a61 42659-011 HUMAN OTC DRUG Plum Emergency Eyewash/Eyewash DUO/Eyewash Shower ISS USA Water LIQUID OPHTHALMIC 20160617 OTC MONOGRAPH FINAL part349 Plum A/S WATER 99.1 mL/100mL E 20171231 42659-022_a0df4dd6-1c67-4403-8f00-6a40af177def 42659-022 HUMAN OTC DRUG Plum pH Neutral Emergency Eyewash/Emergency Eyewash DUO/Emergency Eyewash Shower ISS USA Water LIQUID OPHTHALMIC 20160613 OTC MONOGRAPH FINAL part349 Plum A/S WATER 95.1 mL/100mL E 20171231 42669-001_c7a09388-0013-49be-baf4-eb9129d9073e 42669-001 HUMAN OTC DRUG Perfect Purity Advanced Hand Refreshing Aloe ALCOHOL GEL TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333E Davion, Inc ALCOHOL .7 mL/mL E 20171231 42669-002_5a6c486b-b502-43b1-ae77-91ad68e72e5f 42669-002 HUMAN OTC DRUG Perfect Purity Advanced Hand Sanitizer Refreshing ALCOHOL SOLUTION TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333E Davion, Inc ALCOHOL .7 mL/mL E 20171231 42669-003_d2d4cdea-0e98-4f69-aee8-9d1809738236 42669-003 HUMAN OTC DRUG Perfect Purity Advanced Hand Sanitizer Refreshing ALCOHOL SOLUTION TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333E Davion, Inc ALCOHOL .7 mL/mL E 20171231 42669-007_3b3ca492-feec-413d-b1a7-f12c45e2fb20 42669-007 HUMAN OTC DRUG Perfect Purity Antibacterial Gold Triclosan SOLUTION TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333E Davion, Inc TRICLOSAN .1 mg/100mL E 20171231 42669-009_6ce2c846-cd94-41ee-943e-99b5155402d9 42669-009 HUMAN OTC DRUG Perfect Purity Oil Free Acne Wash Salicyclic Acid RINSE TOPICAL 20170227 OTC MONOGRAPH FINAL part358H Davion, Inc SALICYLIC ACID 2 g/100g N 20181231 42669-111_01a781e8-79a9-4002-91b0-07744d9fb261 42669-111 HUMAN OTC DRUG Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20140331 OTC MONOGRAPH FINAL part347 Davion, Inc DIMETHICONE 13 mg/g E 20171231 42669-200_089faa55-cdf4-2775-e054-00144ff8d46c 42669-200 HUMAN OTC DRUG Perfect Purity Medicated Body Powder menthol and zinc oxide POWDER TOPICAL 20100706 OTC MONOGRAPH FINAL part347 Davion, Inc. MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g E 20171231 42669-201_089faa55-cdff-2775-e054-00144ff8d46c 42669-201 HUMAN OTC DRUG Perfect Purity Medicated Foot Powder menthol POWDER TOPICAL 20101015 OTC MONOGRAPH NOT FINAL part348 Davion, Inc. MENTHOL 1 g/100g E 20171231 42669-203_089faa55-ce0a-2775-e054-00144ff8d46c 42669-203 HUMAN OTC DRUG Premier Value Medicated Body Powder menthol and zinc oxide POWDER TOPICAL 20091229 OTC MONOGRAPH FINAL part347 Davion, Inc. MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g E 20171231 42669-204_089faa55-ce15-2775-e054-00144ff8d46c 42669-204 HUMAN OTC DRUG Premier Value Medicated Foot Powder menthol POWDER TOPICAL 20140505 OTC MONOGRAPH NOT FINAL part348 Davion, Inc. MENTHOL 1 g/100g E 20171231 42669-206_46e4c8c8-57a6-41a1-8378-c6ea72befbf9 42669-206 HUMAN OTC DRUG Assured Medicated Body Powder Menthol POWDER TOPICAL 20171129 OTC MONOGRAPH NOT FINAL part348 Davion, Inc MENTHOL .15 g/100g N 20181231 42669-207_fd1841fb-9b06-4e89-b695-df221c39322e 42669-207 HUMAN OTC DRUG Assured Medicated Foot Powder Menthol POWDER TOPICAL 20171129 OTC MONOGRAPH NOT FINAL part348 Davion, Inc MENTHOL 1 g/100g N 20181231 42669-208_8d9b5217-64a2-4158-a800-1866ffb938e1 42669-208 HUMAN OTC DRUG Perfect Purity Medicated Body Menthol POWDER TOPICAL 20171219 OTC MONOGRAPH FINAL part346 Davion, Inc. MENTHOL .15 g/100g N 20181231 42669-210_08bd2b9b-9cfb-468e-9e4f-f1645f1f3b58 42669-210 HUMAN OTC DRUG Medicated Chest Rub Family Wellness Camphor, Menthol, Eucalyptus Oil CREAM TOPICAL 20151026 OTC MONOGRAPH FINAL part341 Davion, Inc. CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.7; 1; 1 g/100g; g/100g; g/100g N 20181231 42669-211_eb8c9db3-057e-439e-baac-9a93e5da77a0 42669-211 HUMAN OTC DRUG Original Petroleum Petrolatum JELLY TOPICAL 20151026 OTC MONOGRAPH FINAL part347 Davion, Inc. PETROLATUM 100 g/100g N 20181231 42669-214_9639bccb-f586-4cfc-ba2d-e6d77e07e7e3 42669-214 HUMAN OTC DRUG Petroleum Jelly White Petrolatum JELLY TOPICAL 20170110 OTC MONOGRAPH FINAL part347 Davion, Inc. PETROLATUM 100 g/100g N 20181231 42669-215_95ab438b-2f50-4930-931f-f9df1ad7de36 42669-215 HUMAN OTC DRUG Market Basket Anti-Itch Cream Plus Hydrocortisone CREAM TOPICAL 20160306 OTC MONOGRAPH NOT FINAL part348 Davion, Inc. HYDROCORTISONE 1 g/100g E 20171231 42669-216_68fbbe92-921d-48f9-966f-3bae4d6329a1 42669-216 HUMAN OTC DRUG Market Basket First Aid Triple Antibiotic Bacitracin Zinc Neomycin Polymyxin B Sulfate OINTMENT TOPICAL 20160306 OTC MONOGRAPH FINAL part333B Davion, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g E 20171231 42669-222_d32fc6b2-0f32-4127-8574-0242bc7001c0 42669-222 HUMAN OTC DRUG Creamy Petroleum Petrolatum JELLY TOPICAL 20160604 OTC MONOGRAPH FINAL part347 Davion, Inc. PETROLATUM 30 g/100g E 20171231 42669-230_9556e382-daf6-4182-bcf0-d4bde9cdffc7 42669-230 HUMAN OTC DRUG Beauty 360 Soothing Bath Treatment Colloidal oatmeal POWDER TOPICAL 20160901 OTC MONOGRAPH FINAL part347 Davion, Inc. OATMEAL 1000 mg/g E 20171231 42669-231_bf513ab5-6516-42e8-8705-6672383ad6d0 42669-231 HUMAN OTC DRUG Medicated Cornstarch Baby Powder Active Corn Starch POWDER TOPICAL 20160901 OTC MONOGRAPH FINAL part347 Davion, Inc. STARCH, CORN; ZINC OXIDE; KAOLIN 89.27; 16.95; 4.52 g/113g; g/113g; g/113g N 20181231 42669-232_3de49352-b81b-4ffc-bc82-fda69d413ac0 42669-232 HUMAN OTC DRUG Fresh Scent Protective Powder Talc and Zinc Oxide POWDER TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part347 Davion, Inc. TALC; ZINC OXIDE 115; 21.3 g/142g; g/142g N 20181231 42669-998_f4e4d450-27e5-4329-93cc-a971a6e937cd 42669-998 HUMAN OTC DRUG Perfect Purity HotIce Menthol GEL TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part348 Davion, Inc dba HABA MENTHOL 1 g/100g N 20181231 42669-999_9f75fc66-14d4-4648-ab19-41f2834c930c 42669-999 HUMAN OTC DRUG Perfect Purity Vaporizing Chest Rub Menthol, Camphor, Eucalyptus Oil OINTMENT TOPICAL 20131219 OTC MONOGRAPH NOT FINAL part348 Davion, Inc dba HABA MENTHOL; CAMPHOR (SYNTHETIC); EUCALYPTUS OIL 1; 4.7; 1 g/100g; g/100g; g/100g N 20181231 42673-001_5f9b82f7-a554-19a5-e053-2991aa0a718e 42673-001 HUMAN OTC DRUG Epionce Ultra Shield Zinc Oxide, Homosalate, Octisalate LOTION TOPICAL 20090406 OTC MONOGRAPH FINAL part352 Episciences, Inc. ZINC OXIDE; HOMOSALATE; OCTISALATE .101; .1; .05 g/mL; g/mL; g/mL N 20181231 42673-002_2bbee12e-dc3a-4046-a4dd-e506f05fc21b 42673-002 HUMAN PRESCRIPTION DRUG Epionce Active Shield SPF 30 Homosalate, Zinc Oxide, Octisalate LOTION TOPICAL 20050324 OTC MONOGRAPH FINAL part352 Episciences, Inc. HOMOSALATE; ZINC OXIDE; OCTISALATE .1; .92; .05 mL/mL; mL/mL; mL/mL E 20171231 42673-003_5f9a42cb-c820-6e9a-e053-2991aa0ad91d 42673-003 HUMAN OTC DRUG Epionce Active Shield Homosalate, Zinc Oxide, Octisalate LOTION TOPICAL 20050324 20190531 OTC MONOGRAPH FINAL part352 Episciences, Inc. HOMOSALATE; ZINC OXIDE; OCTISALATE .1; .0912; .05 g/g; g/g; g/g N 20181231 42673-004_5f9a5702-94ab-d34f-e053-2a91aa0a5a27 42673-004 HUMAN OTC DRUG Epionce Skin Barrier Repair Kit Homosalate, Octisalate, Zinc Oxide LOTION TOPICAL 20090406 OTC MONOGRAPH FINAL part352 Episciences, Inc. OCTISALATE; HOMOSALATE; ZINC OXIDE .05; .095; .101 g/g; g/g; g/g N 20181231 42673-005_5f9b5fb5-7448-9485-e053-2a91aa0a0748 42673-005 HUMAN OTC DRUG Epionce Daily Shield Tinted SPF 50 Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20170227 OTC MONOGRAPH FINAL part352 Episciences, Inc. TITANIUM DIOXIDE; ZINC OXIDE .048; .093 g/g; g/g N 20181231 42681-0508_6de5bbbc-dcfd-416c-982d-ef4bbbd4d918 42681-0508 HUMAN OTC DRUG Arnica Montana ARNICA MONTANA PELLET SUBLINGUAL 20111123 UNAPPROVED HOMEOPATHIC Whole Foods Market ARNICA MONTANA 30 [hp_C]/1 E 20171231 42681-0512_18e19dd5-49b0-407f-9f40-0ce5080c54db 42681-0512 HUMAN OTC DRUG 365 Everyday Value Arnica ARNICA MONTANA GEL TOPICAL 20080901 UNAPPROVED HOMEOPATHIC WFM Private Label, LP ARNICA MONTANA 1 [hp_X]/1 E 20171231 42681-6414_a3c527d2-e9b9-487c-9819-5ecb1b3f5f63 42681-6414 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20161130 OTC MONOGRAPH NOT FINAL part356 Whole Foods Market HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 42681-6435_476e17f8-e113-6057-e054-00144ff8d46c 42681-6435 HUMAN OTC DRUG ACNE TREATMENT DAILY CLEANSING BAR Salicylic Acid SOAP TOPICAL 20170119 OTC MONOGRAPH FINAL part333D Whole Foods Market SALICYLIC ACID 2 g/100g N 20181231 42681-6512_4ac89e66-9692-0c06-e054-00144ff88e88 42681-6512 HUMAN OTC DRUG Peppermint Cough Drops Menthol LOZENGE ORAL 20170315 OTC MONOGRAPH FINAL part341 Whole Foods Market MENTHOL 5.4 mg/1 N 20181231 42681-6513_4acba242-18c0-693c-e054-00144ff88e88 42681-6513 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20170315 OTC MONOGRAPH FINAL part341 Whole Foods Market MENTHOL 7.5 mg/1 N 20181231 42681-6514_4acb7e35-1432-248c-e054-00144ff8d46c 42681-6514 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20170315 OTC MONOGRAPH FINAL part341 Whole Foods Market MENTHOL 5.8 mg/1 N 20181231 42681-6573_2ff904f6-9bda-49c4-a0a7-b00e960cfc0d 42681-6573 HUMAN OTC DRUG 50 percent Isopropyl alcohol Isopropyl alcohol LIQUID TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Whole Foods Market ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 42681-9032_a425dd0c-f880-4ecf-8b18-3415727e6eb5 42681-9032 HUMAN OTC DRUG 365 Everyday Value Be Well Cough Ease ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA SYRUP ORAL 20110103 UNAPPROVED HOMEOPATHIC WFM Private Label, LP BRYONIA ALBA ROOT; PROTORTONIA CACTI; DROSERA ROTUNDIFOLIA; IPECAC; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; LOBARIA PULMONARIA; ANTIMONY POTASSIUM TARTRATE 3; 3; 3; 3; 6; 6; 3; 3; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 42681-9033_b617c67f-8f08-47e4-808c-358b9c3baa1c 42681-9033 HUMAN OTC DRUG 365 Everyday Value Be Well Cough Ease for Kids ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, PROTORTONIA CACTI, DROSERA ROTUNDIFOLIA, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, PONGIA OFFICINALIS SKELETON, ROASTED, LOBARIA PULMONARIA SYRUP ORAL 20110103 UNAPPROVED HOMEOPATHIC WFM Private Label, LP BRYONIA ALBA ROOT; PROTORTONIA CACTI; DROSERA ROTUNDIFOLIA; IPECAC; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; LOBARIA PULMONARIA; ANTIMONY POTASSIUM TARTRATE 3; 3; 3; 3; 6; 6; 3; 3; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 42681-9280_fd04af5d-9d88-40c9-b2ef-ab142f7f94b5 42681-9280 HUMAN OTC DRUG Flu Ease CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE PELLET ORAL 20150101 UNAPPROVED HOMEOPATHIC WFM Private Label, LP CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/1 N 20181231 42681-9281_fd04af5d-9d88-40c9-b2ef-ab142f7f94b5 42681-9281 HUMAN OTC DRUG Flu Ease CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE PELLET ORAL 20150101 UNAPPROVED HOMEOPATHIC WFM Private Label, LP CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/1 N 20181231 42689-011_f88c821c-deb8-4ff7-9185-6ba94c19131d 42689-011 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150501 ANDA ANDA078065 Nortec Development Associates, Inc PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 42689-012_f88c821c-deb8-4ff7-9185-6ba94c19131d 42689-012 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150501 ANDA ANDA078065 Nortec Development Associates, Inc PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 42689-013_f88c821c-deb8-4ff7-9185-6ba94c19131d 42689-013 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150501 ANDA ANDA078065 Nortec Development Associates, Inc PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 42689-014_f88c821c-deb8-4ff7-9185-6ba94c19131d 42689-014 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150501 ANDA ANDA078065 Nortec Development Associates, Inc PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 42702-102_ff4531e8-5933-4524-bf23-fb7a5e0fc2f5 42702-102 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride phenylephrine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20130415 NDA NDA203510 Paragon BioTeck, Inc. PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] N 20181231 42702-103_ff4531e8-5933-4524-bf23-fb7a5e0fc2f5 42702-103 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride phenylephrine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20130415 NDA NDA203510 Paragon BioTeck, Inc. PHENYLEPHRINE HYDROCHLORIDE 100 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] N 20181231 42707-1001_daca2668-d76f-4e0f-b7da-3224ffffdbae 42707-1001 HUMAN OTC DRUG Dangsim K-7 MOMORDICA CHARANTIA FRUIT GRANULE ORAL 20120207 UNAPPROVED DRUG OTHER Korea Genetic Pharm Co., Ltd MOMORDICA CHARANTIA FRUIT 13 g/100g E 20171231 42707-2001_31876fea-b452-41c1-8723-2db49e9cee82 42707-2001 HUMAN OTC DRUG Energain TRIBULUS TERRESTRIS ROOT GRANULE ORAL 20120207 UNAPPROVED DRUG OTHER Korea Genetic Pharm Co., Ltd TRIBULUS TERRESTRIS ROOT 8 g/100g E 20171231 42707-3001_98176a68-19cf-4762-806f-fdc2d8e5ee04 42707-3001 HUMAN OTC DRUG Ginseng Khan PANAX GINSENG FRUIT LIQUID ORAL 20120215 UNAPPROVED DRUG OTHER Korea Genetic Pharm Co., Ltd PANAX GINSENG FRUIT 90 mL/100mL E 20171231 42715-001_61947d16-8787-3c1b-e053-2a91aa0a190b 42715-001 HUMAN OTC DRUG Emerald Green Neutral pH Anti-Bacterial Hand CHLOROXYLENOL SOAP TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E Walter E. Nelson Co. CHLOROXYLENOL 4 mg/mL N 20191231 42715-002_6194dd5c-74ee-2385-e053-2991aa0a318d 42715-002 HUMAN OTC DRUG CLEAR AND CLEAN Neutral pH Antiseptic Hand Wash CHLOROXYLENOL LIQUID TOPICAL 20130221 OTC MONOGRAPH NOT FINAL part333A Walter E. Nelson Co. CHLOROXYLENOL 4 mg/mL N 20181231 42716-001_6194dd5c-74fd-2385-e053-2991aa0a318d 42716-001 HUMAN OTC DRUG INCHCO Brand SANI-DERM Antiseptic Hand Wash CHLOROXYLENOL SOAP TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E Inland Supply Co., Inc. CHLOROXYLENOL 4 mg/mL N 20181231 42719-345_aa25aefc-ee31-470e-b94e-742a6e37aa50 42719-345 HUMAN OTC DRUG Stay Clean Foam Hand Sanitizer Hand Sanitizer LIQUID TOPICAL 20090918 OTC MONOGRAPH NOT FINAL part333 Byotrol, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 42719-346_ca36ae2a-21c1-46a3-96cc-de95950d92ae 42719-346 HUMAN OTC DRUG Byotrol Antibacterial Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130308 OTC MONOGRAPH NOT FINAL part333A Byotrol, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 42719-347_390ab5f1-e771-4d12-8f2a-8271a50f8403 42719-347 HUMAN OTC DRUG WSNA Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140122 OTC MONOGRAPH NOT FINAL part333A Byotrol, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 42721-112_1ca417b7-a218-4ee2-8866-8f89eabc43a7 42721-112 HUMAN PRESCRIPTION DRUG Monsels solution Ferric Sub Sulfate 20% LIQUID TOPICAL 20140826 UNAPPROVED DRUG OTHER BIODIAGNOSTIC INTERNATIONAL FERRIC SUBSULFATE 20 g/100g Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] E 20171231 42731-002_774be21f-b325-4a3a-8714-87b92dcc94b1 42731-002 HUMAN OTC DRUG Triple Allergy Defense Allium cepa, Amrbosia artemisiifolia, Arsenicum album, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Lemna minor, Linum usitatissimum, Luffa operculata, Natrum muriaticum, Polyporus pinicola, Sabadilla LIQUID ORAL 20130308 UNAPPROVED HOMEOPATHIC Nenningers Naturals, LLC ALLIUM CEPA WHOLE; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LEMNA MINOR; FLAX SEED; LUFFA OPERCULATA FRUIT; SODIUM CHLORIDE; FOMITOPSIS PINICOLA FRUITING BODY; SCHOENOCAULON OFFICINALE SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL N 20181231 42731-012_eaba740c-976b-4973-8823-dde0ec69ac90 42731-012 HUMAN OTC DRUG Triple Flu Defense Alianthus, Ana barbariae, Arsenicum album, Byronia, Eucalyptus, Eupatorium perfoliatum, Gelsemium, Glycerinum, Influenzinum, Mercurius vivus, Phytolacca, Sticta pulmonaria LIQUID ORAL 20121127 UNAPPROVED HOMEOPATHIC Nenningers Naturals, LLC AILANTHUS ALTISSIMA FLOWERING TWIG; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GLYCERIN; INFLUENZA A VIRUS A/NEW CALEDONIA/20/99 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/HONG KONG/330/2001 ANTIGEN (PROPIOLACTONE INACTIVATED); MERCURY; PHYTOLACCA AMERICANA ROOT; LOBARIA PULMONARIA; INFLUENZA A VIRUS A/PANAMA/2007/99 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL N 20181231 42731-022_1c95f039-8029-430f-81b8-2514b816caed 42731-022 HUMAN OTC DRUG Triple Flu Defense Aconite, Ailanthus, Anas barbariae, Belladonna, Bryonia, Gelsemium, Influenzinum, Lycopodium, Mercurius vivus, Phosphorus, Phytolacca, Spongia LIQUID ORAL 20160901 UNAPPROVED HOMEOPATHIC Nenningers Naturals, LLC ACONITUM NAPELLUS ROOT; AILANTHUS ALTISSIMA FLOWERING TWIG; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL N 20181231 42731-032_ec443c42-6c6a-465b-98d1-86780994fb6c 42731-032 HUMAN OTC DRUG Triple Allergy Defense Allium cepa, Ambrosia artemisiifolia, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Hydrastis canadensis, Lemna minor, Linum usitatissimum, Luffa operculata, Natrum muriaticum, Polyporus pinicola, Sabadilla LIQUID ORAL 20160901 UNAPPROVED HOMEOPATHIC Nenningers Naturals, LLC ALLIUM CEPA WHOLE; AMBROSIA ARTEMISIIFOLIA; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; HYDRASTIS CANADENSIS WHOLE; LEMNA MINOR; FLAX SEED; LUFFA OPERCULATA FRUIT; SODIUM CHLORIDE; FOMITOPSIS PINICOLA FRUITING BODY; SCHOENOCAULON OFFICINALE SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL N 20181231 42737-101_06b843a2-c662-41f6-a07e-b06cc01e04fe 42737-101 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE temozolomide CAPSULE ORAL 20171101 ANDA ANDA204639 Chemi Pharma LLC TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 42737-102_06b843a2-c662-41f6-a07e-b06cc01e04fe 42737-102 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE temozolomide CAPSULE ORAL 20171101 ANDA ANDA204639 Chemi Pharma LLC TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 42737-103_06b843a2-c662-41f6-a07e-b06cc01e04fe 42737-103 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE temozolomide CAPSULE ORAL 20171101 ANDA ANDA204639 Chemi Pharma LLC TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 42737-104_06b843a2-c662-41f6-a07e-b06cc01e04fe 42737-104 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE temozolomide CAPSULE ORAL 20171101 ANDA ANDA204639 Chemi Pharma LLC TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 42737-105_06b843a2-c662-41f6-a07e-b06cc01e04fe 42737-105 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE temozolomide CAPSULE ORAL 20171101 ANDA ANDA204639 Chemi Pharma LLC TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 42737-106_06b843a2-c662-41f6-a07e-b06cc01e04fe 42737-106 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE temozolomide CAPSULE ORAL 20171101 ANDA ANDA204639 Chemi Pharma LLC TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 42738-210_8290701f-02ef-41c1-94aa-5767d65e66a2 42738-210 HUMAN OTC DRUG BZK Cleansing Benzalkonium Chloride SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A Family Hospitality LLC BENZALKONIUM CHLORIDE 1 mL/750mL N 20181231 42743-4700_605ebeb6-c4ad-4c3e-8a6d-e15b63041dda 42743-4700 HUMAN OTC DRUG American Crew Anti-Dandruff plus Sebum Control Pyrithione Zinc SHAMPOO CUTANEOUS 20130831 OTC MONOGRAPH FINAL part358H Colomer USA, Ltd. PYRITHIONE ZINC 10 mg/mL E 20171231 42747-221_d07bb89b-1d6e-43a0-839d-d85a8f0619c5 42747-221 HUMAN PRESCRIPTION DRUG Abstral fentanyl TABLET SUBLINGUAL 20110107 NDA NDA022510 ProStrakan, Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 42747-222_d07bb89b-1d6e-43a0-839d-d85a8f0619c5 42747-222 HUMAN PRESCRIPTION DRUG Abstral fentanyl TABLET SUBLINGUAL 20110107 NDA NDA022510 ProStrakan, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 42747-223_d07bb89b-1d6e-43a0-839d-d85a8f0619c5 42747-223 HUMAN PRESCRIPTION DRUG Abstral fentanyl TABLET SUBLINGUAL 20110107 NDA NDA022510 ProStrakan, Inc. FENTANYL CITRATE 300 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 42747-224_d07bb89b-1d6e-43a0-839d-d85a8f0619c5 42747-224 HUMAN PRESCRIPTION DRUG Abstral fentanyl TABLET SUBLINGUAL 20110107 NDA NDA022510 ProStrakan, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 42747-226_d07bb89b-1d6e-43a0-839d-d85a8f0619c5 42747-226 HUMAN PRESCRIPTION DRUG Abstral fentanyl TABLET SUBLINGUAL 20110107 NDA NDA022510 ProStrakan, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 42747-228_d07bb89b-1d6e-43a0-839d-d85a8f0619c5 42747-228 HUMAN PRESCRIPTION DRUG Abstral fentanyl TABLET SUBLINGUAL 20110107 NDA NDA022510 ProStrakan, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 42747-235_af05dde8-1c06-4cd5-bcd0-8e318874536a 42747-235 HUMAN PRESCRIPTION DRUG Rectiv nitroglycerin OINTMENT RECTAL 20110621 NDA NDA021359 ProStrakan, Inc. NITROGLYCERIN 4 mg/g Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 42747-327_2009e5ef-6524-4b62-b34f-145e63c371c4 42747-327 HUMAN PRESCRIPTION DRUG Fareston toremifene citrate TABLET ORAL 19970630 NDA NDA020497 KYOWA KIRIN, INC, TOREMIFENE CITRATE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 42747-726_f743a972-af5d-4b51-9431-e1f5575fc638 42747-726 HUMAN PRESCRIPTION DRUG Sancuso granisetron PATCH TRANSDERMAL 20080912 NDA NDA022198 Kyowa Kirin, Inc. GRANISETRON 3.1 mg/24h Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 42751-1070_a07b5b9a-5739-442e-978f-e7f2c77b4946 42751-1070 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20080206 UNAPPROVED MEDICAL GAS Fullerton Welding Supply NITROUS OXIDE 99 L/100L E 20171231 42751-1072_a1d5d7fe-384d-43dc-9494-38abd2e184a3 42751-1072 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20080206 UNAPPROVED MEDICAL GAS Fullerton Welding Supply OXYGEN 99 L/100L E 20171231 42756-1030_cc1bbc86-cbb2-4eb4-86d2-9845e69ee3be 42756-1030 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine Bitartrate Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 IQ Dental LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 42756-1080_a1381559-fab4-4a36-bd49-80e39dcfaabf 42756-1080 HUMAN PRESCRIPTION DRUG IQ Dental Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20120815 ANDA ANDA088387 IQ Dental MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 42756-1100_15042051-edcc-4ffe-845d-aa5d9d1936fe 42756-1100 HUMAN PRESCRIPTION DRUG NRG Hemo-Stat Aluminum Chloride SOLUTION DENTAL 20141101 UNAPPROVED DRUG OTHER IQ Dental Supply, LLC ALUMINUM CHLORIDE 7500 mg/30mL N 20181231 42756-1101_2a0a051e-9b02-449e-9dc9-752d38a5f179 42756-1101 HUMAN OTC DRUG NRG Topical Anesthetic Benzocaine GEL DENTAL 20130801 OTC MONOGRAPH NOT FINAL part356 IQ Dental Supply, LLC BENZOCAINE 200 mg/g N 20181231 42756-1102_2dd2290c-db4d-4bdf-92ab-b56ab45b6e63 42756-1102 HUMAN OTC DRUG NRG Topical Anesthetic Benzocaine GEL DENTAL 20130801 OTC MONOGRAPH NOT FINAL part356 IQ Dental Supply, LLC BENZOCAINE 200 mg/g N 20181231 42756-1103_19cc5e79-4228-4ebc-b65f-19589eea107c 42756-1103 HUMAN OTC DRUG NRG Topical Anesthetic Benzocaine GEL DENTAL 20130801 OTC MONOGRAPH NOT FINAL part356 IQ Dental Supply, LLC BENZOCAINE 200 mg/g N 20181231 42756-1104_2217820b-2362-47ef-a88a-239a3c306036 42756-1104 HUMAN OTC DRUG NRG Topical Anesthetic Benzocaine GEL DENTAL 20130801 OTC MONOGRAPH NOT FINAL part356 IQ Dental Supply, LLC BENZOCAINE 200 mg/g N 20181231 42756-1105_c4413d7a-50db-4dd9-9029-3d37ba420765 42756-1105 HUMAN OTC DRUG NRG Topical Anesthetic Benzocaine GEL DENTAL 20130801 OTC MONOGRAPH NOT FINAL part356 IQ Dental Supply, LLC BENZOCAINE 200 mg/g N 20181231 42756-1106_86e12568-ed24-475d-a506-1f74fee65218 42756-1106 HUMAN OTC DRUG NRG Topical Anesthetic Benzocaine GEL DENTAL 20130801 OTC MONOGRAPH NOT FINAL part356 IQ Dental Supply, LLC BENZOCAINE 200 mg/g N 20181231 42756-1107_a07a8176-a844-4391-8dce-745047e72c74 42756-1107 HUMAN OTC DRUG NRG Topical Anesthetic Benzocaine GEL DENTAL 20130801 OTC MONOGRAPH NOT FINAL part356 IQ Dental Supply, LLC BENZOCAINE 200 mg/g N 20181231 42756-1108_1f22375f-0084-461b-bc93-58770d158e94 42756-1108 HUMAN OTC DRUG NRG Topical Anesthetic Benzocaine GEL DENTAL 20130801 OTC MONOGRAPH NOT FINAL part356 IQ Dental Supply, LLC BENZOCAINE 200 mg/g N 20181231 42756-1109_cd4d3fba-c51b-4cac-a9e6-4e0fd0ccb390 42756-1109 HUMAN OTC DRUG NRG Topical Anesthetic Benzocaine GEL DENTAL 20130801 OTC MONOGRAPH NOT FINAL part356 IQ Dental Supply, LLC BENZOCAINE 200 mg/g N 20181231 42756-1110_fb9c8eb2-52da-49df-98ab-8d7d5972aff6 42756-1110 HUMAN PRESCRIPTION DRUG NRG APF Sodium Fluoride GEL DENTAL 20130801 UNAPPROVED DRUG OTHER IQ Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 42756-1111_f7d0ac07-c29d-4506-9988-1072bcb48f38 42756-1111 HUMAN PRESCRIPTION DRUG NRG APF Sodium Fluoride GEL DENTAL 20130801 UNAPPROVED DRUG OTHER IQ Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 42756-1112_5de625fe-b843-4261-84cc-fc43d3824e7c 42756-1112 HUMAN PRESCRIPTION DRUG NRG APF Sodium Fluoride GEL DENTAL 20130801 UNAPPROVED DRUG OTHER IQ Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 42756-1113_10c51243-a06e-4697-bd5a-82b1d107b520 42756-1113 HUMAN PRESCRIPTION DRUG NRG APF Sodium Fluoride GEL DENTAL 20130801 UNAPPROVED DRUG OTHER IQ Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 42756-1114_f3ca2b25-886c-454a-bad8-913f3c3f7f9c 42756-1114 HUMAN PRESCRIPTION DRUG NRG APF Sodium Fluoride GEL DENTAL 20130801 UNAPPROVED DRUG OTHER IQ Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 42756-1115_a0e09727-be05-4f3a-b4cc-ac937b021972 42756-1115 HUMAN PRESCRIPTION DRUG NRG APF Sodium Fluoride GEL DENTAL 20130801 UNAPPROVED DRUG OTHER IQ Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 42756-1116_c28c2892-167d-46c3-9074-614854f34ac7 42756-1116 HUMAN PRESCRIPTION DRUG NRG APF Sodium Fluoride GEL DENTAL 20130801 UNAPPROVED DRUG OTHER IQ Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 42756-1120_c52b7cb5-e107-4f3d-88f7-77895ab36bfa 42756-1120 HUMAN PRESCRIPTION DRUG NRG APF Sodium Fluoride AEROSOL, FOAM DENTAL 20131001 UNAPPROVED DRUG OTHER IQ Dental Supply, LLC SODIUM FLUORIDE 1.5375 g/125g E 20171231 42756-1121_8ca5ca81-d4f7-4d6d-89e5-4dc5bb7f2e47 42756-1121 HUMAN PRESCRIPTION DRUG NRG APF Sodium Fluoride AEROSOL, FOAM DENTAL 20131001 UNAPPROVED DRUG OTHER IQ Dental Supply, LLC SODIUM FLUORIDE 1.5375 g/125g E 20171231 42756-1122_e2f1b94c-b4a8-4da2-8bfe-361b0009298b 42756-1122 HUMAN PRESCRIPTION DRUG NRG APF Sodium Fluoride AEROSOL, FOAM DENTAL 20131001 UNAPPROVED DRUG OTHER IQ Dental Supply, LLC SODIUM FLUORIDE 1.5375 g/125g E 20171231 42756-1123_914a0dd2-5215-414d-9bb3-a604d6c49536 42756-1123 HUMAN PRESCRIPTION DRUG NRG APF Sodium Fluoride AEROSOL, FOAM DENTAL 20131001 UNAPPROVED DRUG OTHER IQ Dental Supply, LLC SODIUM FLUORIDE 1.5375 g/125g E 20171231 42766-001_6194fc0b-2ce3-a3af-e053-2a91aa0a1d4d 42766-001 HUMAN OTC DRUG SAC-VAL Premium Clear Antiseptic Hand Wash CHLOROXYLENOL SOAP TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E Sac Val Janitorial Sales & Service, Inc. CHLOROXYLENOL 4 mg/mL N 20181231 42771-0001_5312f8d0-9b1a-69b8-e054-00144ff88e88 42771-0001 HUMAN OTC DRUG Coral KAVI sulfur SOAP TOPICAL 20030501 OTC MONOGRAPH FINAL part358H KAVI Skin Solutions, Inc. SULFUR; SALICYLIC ACID 2; 3 g/100g; g/100g N 20181231 42771-0036_5313266e-a04e-7118-e054-00144ff88e88 42771-0036 HUMAN OTC DRUG DermaWash S2 sulfur soap SOAP TOPICAL 20070301 OTC MONOGRAPH FINAL part358H KAVI Skin Solutions, Inc. SULFUR 2 g/100g N 20181231 42783-101_9910c570-35f6-4748-bce0-a4cfb99f7af3 42783-101 HUMAN PRESCRIPTION DRUG ZITHRANOL-RR anthralin CREAM TOPICAL 20090709 UNAPPROVED DRUG OTHER Elorac Inc. ANTHRALIN .012 g/g E 20171231 42783-111_29705f8e-766e-4ef9-9ca7-3e9a9dee9daa 42783-111 HUMAN PRESCRIPTION DRUG Zithranol Anthralin SHAMPOO TOPICAL 20120305 UNAPPROVED DRUG OTHER Elorac Inc. ANTHRALIN 1 g/100g E 20171231 42783-312_91b5ab12-97ca-4765-a8ed-b125ade861da 42783-312 HUMAN PRESCRIPTION DRUG Virasal salicylic acid SOLUTION TOPICAL 20110401 UNAPPROVED DRUG OTHER Elorac, Inc. SALICYLIC ACID 275 mg/mL E 20171231 42783-323_ca5760e5-6352-440c-83c7-9ad7b7679694 42783-323 HUMAN PRESCRIPTION DRUG Ultrasal-ER salicylic acid SOLUTION TOPICAL 20140130 UNAPPROVED DRUG OTHER Elorac, Inc. SALICYLIC ACID 285 mg/mL E 20171231 42783-601_4f65bb83-e446-47a4-af86-a5086c4b7648 42783-601 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20051208 ANDA ANDA065285 Elorac, Inc. DOXYCYCLINE 100 mg/1 N 20181231 42783-601_881b762a-b1e5-436c-800a-0f058967d0a8 42783-601 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20051208 ANDA ANDA065285 Elorac, Inc. DOXYCYCLINE 100 mg/1 N 20181231 42783-633_4db3b47f-ab70-4701-aa42-06c35640820e 42783-633 HUMAN PRESCRIPTION DRUG BenzoDox 30 Kit Doxycycline Tablets and Advanced Acne Wash KIT 20151001 UNAPPROVED DRUG OTHER Elorac, Inc. E 20171231 42783-635_2288e7cb-48aa-47e2-9550-49814fdf3578 42783-635 HUMAN OTC DRUG Advanced Acne Wash Benzoyl Peroxide LIQUID, EXTENDED RELEASE TOPICAL 20150917 OTC MONOGRAPH FINAL part333D Elorac, Inc. BENZOYL PEROXIDE 44 mg/mL N 20181231 42783-663_106fac06-68f6-4308-b7d1-a24eeef6366d 42783-663 HUMAN PRESCRIPTION DRUG BenzoDox 60 Kit Doxycycline Tablets and Advanced Acne Wash KIT 20150922 UNAPPROVED DRUG OTHER Elorac, Inc. E 20171231 42787-101_45375d2d-b519-4e3c-800e-b3eefa0e6857 42787-101 HUMAN OTC DRUG Value Pharma Aspirin Pain Reliever Aspirin TABLET ORAL 20121001 OTC MONOGRAPH FINAL part343 Ajes Pharmaceuticals,LLC ASPIRIN 81 mg/81mg E 20171231 42787-101_83ab9ae9-51ce-4763-a39a-03585c908116 42787-101 HUMAN OTC DRUG Value Pharma Aspirin Pain Reliever Aspirin TABLET ORAL 20121001 OTC MONOGRAPH FINAL part343 Ajes Pharmaceuticals,LLC ASPIRIN 81 mg/81mg E 20171231 42787-102_615db3ad-3529-4e96-962a-96324d2c5c97 42787-102 HUMAN OTC DRUG Value PharmaPain Reliever Extra Strength Aspirin TABLET ORAL 20121001 OTC MONOGRAPH FINAL part343 Ajes Pharmaceuticals,LLC ASPIRIN 325 mg/325mg E 20171231 42787-102_893f4de2-d639-4e24-9c95-741b3f90a25e 42787-102 HUMAN OTC DRUG Value PharmaPain Reliever Extra Strength Aspirin TABLET ORAL 20121001 OTC MONOGRAPH FINAL part343 Ajes Pharmaceuticals,LLC ASPIRIN 325 mg/325mg E 20171231 42787-104_33e8167f-3d6f-42eb-be0e-abe2dcb25f5d 42787-104 HUMAN OTC DRUG BENALDRYL DIPHENHYDRAMINE HCL TABLET ORAL 20120901 OTC MONOGRAPH NOT FINAL part348 AJES PHARMACEUTICALS,LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/250mg E 20171231 42787-104_6854488c-af16-4d30-9a24-bcf3aafac41e 42787-104 HUMAN OTC DRUG BENALDRYL DIPHENHYDRAMINE HCL TABLET ORAL 20120901 OTC MONOGRAPH NOT FINAL part348 AJES PHARMACEUTICALS,LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/250mg E 20171231 42787-105_6558ce50-cba7-464e-9cad-a0206629c2ef 42787-105 HUMAN OTC DRUG SENOKOT-S Docuset Sodium PILL ORAL 20120901 OTC MONOGRAPH NOT FINAL part334 Ajes Pharmaceuticals,LLC DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/340mg; mg/340mg E 20171231 42792-101_60294c50-c96e-a737-e053-2a91aa0a0b2b 42792-101 HUMAN PRESCRIPTION DRUG UREA UREA CREAM TOPICAL 20110309 UNAPPROVED DRUG OTHER AUSTIN PHARMACEUTICALS, LLC UREA 390 mg/g N 20181231 42794-003_4bb4876d-e5ed-4c8e-9219-edd51a3f8658 42794-003 HUMAN PRESCRIPTION DRUG ADEFOVIR DIPIVOXIL ADEFOVIR DIPIVOXIL TABLET ORAL 20130903 ANDA ANDA202051 Sigmapharm Laboratories, LLC ADEFOVIR DIPIVOXIL 10 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 42794-006_82aa1a28-0cb4-479d-98a5-eadef2607f6a 42794-006 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20120128 ANDA ANDA091004 SigmaPharm Laboratories, LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 42794-018_93f67b3c-c378-4290-b74e-d6e28416ee64 42794-018 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20121203 ANDA ANDA200295 SIGMAPHARM LABORATORIES, LLC LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 42794-019_93f67b3c-c378-4290-b74e-d6e28416ee64 42794-019 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20121203 ANDA ANDA200295 SIGMAPHARM LABORATORIES, LLC LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 42794-020_93f67b3c-c378-4290-b74e-d6e28416ee64 42794-020 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20121203 ANDA ANDA200295 SIGMAPHARM LABORATORIES, LLC LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 42794-080_6067067c-e32c-34df-e053-2a91aa0ad0cf 42794-080 HUMAN PRESCRIPTION DRUG ACITRETIN ACITRETIN CAPSULE ORAL 20150916 ANDA ANDA204633 Sigmapharm Laboratories, LLC ACITRETIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 42794-081_6067067c-e32c-34df-e053-2a91aa0ad0cf 42794-081 HUMAN PRESCRIPTION DRUG ACITRETIN ACITRETIN CAPSULE ORAL 20150916 ANDA ANDA204633 Sigmapharm Laboratories, LLC ACITRETIN 17.5 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 42794-083_6067067c-e32c-34df-e053-2a91aa0ad0cf 42794-083 HUMAN PRESCRIPTION DRUG ACITRETIN ACITRETIN CAPSULE ORAL 20150916 ANDA ANDA204633 Sigmapharm Laboratories, LLC ACITRETIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 42794-086_f10bb4cd-8629-4a6e-97c7-54f7652f5779 42794-086 HUMAN PRESCRIPTION DRUG Sodium Phenylbutyrate Sodium Phenylbutyrate POWDER ORAL 20130404 ANDA ANDA202819 Sigmapharm Laboratories, LLC SODIUM PHENYLBUTYRATE .94 g/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 42799-105_520bf7d8-4b5c-407e-ae3d-aef07547e0e1 42799-105 HUMAN PRESCRIPTION DRUG Methenamine Mandelate Methenamine Mandelate TABLET ORAL 20091215 UNAPPROVED DRUG OTHER Edenbridge Pharmaceuticals, LLC METHENAMINE MANDELATE 500 mg/1 N 20181231 42799-106_520bf7d8-4b5c-407e-ae3d-aef07547e0e1 42799-106 HUMAN PRESCRIPTION DRUG Methenamine Mandelate Methenamine Mandelate TABLET ORAL 20091215 UNAPPROVED DRUG OTHER Edenbridge Pharmaceuticals, LLC METHENAMINE MANDELATE 1000 mg/1 N 20181231 42799-119_a5a4834e-6ef2-4727-a930-65255a25c9f4 42799-119 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20151015 NDA AUTHORIZED GENERIC NDA018225 Edenbridge Pharmaceuticals, LLC BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 42799-120_a5a4834e-6ef2-4727-a930-65255a25c9f4 42799-120 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20151015 NDA AUTHORIZED GENERIC NDA018225 Edenbridge Pharmaceuticals, LLC BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 42799-121_a5a4834e-6ef2-4727-a930-65255a25c9f4 42799-121 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20151015 NDA AUTHORIZED GENERIC NDA018225 Edenbridge Pharmaceuticals, LLC BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 42799-123_7e10c56b-e906-474b-82a4-ca6fdf700e76 42799-123 HUMAN PRESCRIPTION DRUG Carbidopa Carbidopa TABLET ORAL 20160302 ANDA ANDA205304 Edenbridge Pharmaceuticals LLC CARBIDOPA 25 mg/1 N 20181231 42799-207_057c5441-862c-4ae8-8dce-fb00ccfb23d9 42799-207 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20150810 ANDA ANDA203808 Edenbridge Pharmaceuticals, LLC TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 42799-208_057c5441-862c-4ae8-8dce-fb00ccfb23d9 42799-208 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20150810 ANDA ANDA203808 Edenbridge Pharmaceuticals, LLC TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 42799-217_5b376952-010f-adfc-e053-2a91aa0ae464 42799-217 HUMAN PRESCRIPTION DRUG Opium Tincture Deodorized Morphine TINCTURE ORAL 20100715 UNAPPROVED DRUG OTHER Edenbridge Pharmaceuticals, LLC MORPHINE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42799-405_8eed5053-6773-42ac-bf0a-d7aaf440fdb8 42799-405 HUMAN PRESCRIPTION DRUG Ethacrynic Acid Ethacrynic Acid TABLET ORAL 20160705 ANDA ANDA205609 Edenbridge Pharmaceuticals, LLC ETHACRYNIC ACID 25 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 42799-806_c2644c32-f00f-4f95-9eb6-fe678b224c02 42799-806 HUMAN PRESCRIPTION DRUG Ivermectin Ivermectin TABLET ORAL 20141115 ANDA ANDA204154 Edenbridge Pharmaceuticals, LLC IVERMECTIN 3 mg/1 Antiparasitic [EPC],Pediculicide [EPC] N 20181231 42799-812_0519d344-cfc5-49ac-8fa0-177707b1f28b 42799-812 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20161221 ANDA ANDA203559 Edenbridge Pharmaceuticals, LLC PREDNISOLONE SODIUM PHOSPHATE 10 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 42799-813_0519d344-cfc5-49ac-8fa0-177707b1f28b 42799-813 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20161221 ANDA ANDA203559 Edenbridge Pharmaceuticals, LLC PREDNISOLONE SODIUM PHOSPHATE 20 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 42806-005_eab17d01-ab9e-4660-9d65-afb463305b88 42806-005 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20150922 ANDA ANDA202662 Epic Pharma, LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42806-006_eab17d01-ab9e-4660-9d65-afb463305b88 42806-006 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20150922 ANDA ANDA202662 Epic Pharma, LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42806-007_eab17d01-ab9e-4660-9d65-afb463305b88 42806-007 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20150922 ANDA ANDA202662 Epic Pharma, LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42806-008_eab17d01-ab9e-4660-9d65-afb463305b88 42806-008 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20150922 ANDA ANDA202662 Epic Pharma, LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42806-009_eab17d01-ab9e-4660-9d65-afb463305b88 42806-009 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20150922 ANDA ANDA202662 Epic Pharma, LLC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42806-011_60124926-903c-f2e7-e053-2a91aa0aabe4 42806-011 HUMAN PRESCRIPTION DRUG SULINDAC SULINDAC TABLET ORAL 20100125 ANDA ANDA072711 Epic Pharma, LLC SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42806-012_60155fb3-89e2-3f4c-e053-2a91aa0aec20 42806-012 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 Epic Pharma, LLC MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 42806-013_85b34102-4d2d-40ee-afaa-62a14435e37c 42806-013 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate POWDER, FOR SUSPENSION ORAL 20140414 ANDA ANDA202333 Epic Pharma, LLC SODIUM POLYSTYRENE SULFONATE 4.1 meq/g N 20181231 42806-014_60155fb3-89e2-3f4c-e053-2a91aa0aec20 42806-014 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 Epic Pharma, LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 42806-018_60124926-903c-f2e7-e053-2a91aa0aabe4 42806-018 HUMAN PRESCRIPTION DRUG SULINDAC SULINDAC TABLET ORAL 20100125 ANDA ANDA072710 Epic Pharma, LLC SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 42806-019_5faf6e49-59f7-4c5d-e053-2991aa0ac711 42806-019 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET, FILM COATED ORAL 20110520 ANDA ANDA077045 Epic Pharma, LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42806-020_5faf6e49-59f7-4c5d-e053-2991aa0ac711 42806-020 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET, FILM COATED ORAL 20110520 ANDA ANDA077045 Epic Pharma, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42806-021_5faf6e49-59f7-4c5d-e053-2991aa0ac711 42806-021 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET, FILM COATED ORAL 20110520 ANDA ANDA077045 Epic Pharma, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 42806-038_603d281a-fad0-1f14-e053-2a91aa0a52df 42806-038 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20100720 ANDA ANDA075541 Epic Pharma LLC BETAXOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 42806-039_603d281a-fad0-1f14-e053-2a91aa0a52df 42806-039 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20100720 ANDA ANDA075541 Epic Pharma LLC BETAXOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 42806-048_5df43cdd-92af-2868-e053-2991aa0ac410 42806-048 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 20131202 20180930 ANDA ANDA074673 Epic Pharma, LLC GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 42806-049_5df43cdd-92af-2868-e053-2991aa0ac410 42806-049 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 20131202 20180731 ANDA ANDA074673 Epic Pharma, LLC GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 42806-050_f698ac35-4d14-41cf-8048-9d9b5da81df4 42806-050 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 20110505 ANDA ANDA040331 Epic Pharma, LLC MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42806-051_f698ac35-4d14-41cf-8048-9d9b5da81df4 42806-051 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 20110505 ANDA ANDA040331 Epic Pharma, LLC MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42806-052_5f5046f9-28d6-dd83-e053-2991aa0a9965 42806-052 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril Tablets TABLET ORAL 20150331 ANDA ANDA078508 Epic Pharma, LLC TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 42806-053_5f5046f9-28d6-dd83-e053-2991aa0a9965 42806-053 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril Tablets TABLET ORAL 20150331 ANDA ANDA078508 Epic Pharma, LLC TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 42806-054_5f5046f9-28d6-dd83-e053-2991aa0a9965 42806-054 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril Tablets TABLET ORAL 20150331 ANDA ANDA078508 Epic Pharma, LLC TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 42806-055_d285b21b-48dc-4432-8443-b7385f80c094 42806-055 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20110425 ANDA ANDA078552 Epic Pharma, LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 42806-056_d285b21b-48dc-4432-8443-b7385f80c094 42806-056 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20110425 ANDA ANDA078552 Epic Pharma, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 42806-057_d285b21b-48dc-4432-8443-b7385f80c094 42806-057 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20110425 ANDA ANDA078552 Epic Pharma, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 42806-058_0b80ec7b-23e5-4ebb-90a1-8a30cf086d82 42806-058 HUMAN PRESCRIPTION DRUG Flavoxate Hydrochloride Flavoxate Hydrochloride TABLET ORAL 20110221 ANDA ANDA076835 Epic Pharma, LLC FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 42806-081_df72f520-f978-491d-8382-382491d18174 42806-081 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride TABLET, FILM COATED ORAL 20151216 ANDA ANDA090346 Epic Pharma, LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 42806-087_72561a3d-126d-4ed0-aa85-c1e9f19e6043 42806-087 HUMAN PRESCRIPTION DRUG ESTRADIOL ESTRADIOL TABLET ORAL 20170410 ANDA ANDA040275 Epic Pharma, LLC ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 42806-088_72561a3d-126d-4ed0-aa85-c1e9f19e6043 42806-088 HUMAN PRESCRIPTION DRUG ESTRADIOL ESTRADIOL TABLET ORAL 20170410 ANDA ANDA040275 Epic Pharma, LLC ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 42806-089_72561a3d-126d-4ed0-aa85-c1e9f19e6043 42806-089 HUMAN PRESCRIPTION DRUG ESTRADIOL ESTRADIOL TABLET ORAL 20170410 ANDA ANDA040275 Epic Pharma, LLC ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 42806-096_fa10b911-5e96-40d7-b473-03b581531fab 42806-096 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET, FILM COATED ORAL 20130109 ANDA ANDA202220 Epic Pharma, LLC PROTRIPTYLINE HYDROCHLORIDE 5 mg/1 Tricyclic Antidepressant [EPC] N 20181231 42806-097_fa10b911-5e96-40d7-b473-03b581531fab 42806-097 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET, FILM COATED ORAL 20130109 ANDA ANDA202220 Epic Pharma, LLC PROTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 42806-121_5fc7348d-da9d-47cf-e053-2991aa0aa101 42806-121 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20160104 ANDA ANDA077070 Epic Pharma, LLC SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 42806-122_5fc7348d-da9d-47cf-e053-2991aa0aa101 42806-122 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20160104 ANDA ANDA077070 Epic Pharma, LLC SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 42806-123_5fc7348d-da9d-47cf-e053-2991aa0aa101 42806-123 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20160104 ANDA ANDA077070 Epic Pharma, LLC SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 42806-143_6014fc1e-f13b-3505-e053-2a91aa0a7828 42806-143 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20150202 ANDA ANDA065447 Epic Pharma, LLC DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 42806-144_6014fc1e-f13b-3505-e053-2a91aa0a7828 42806-144 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20150202 ANDA ANDA065447 Epic Pharma, LLC DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 42806-159_4fe0f556-973c-4d64-be5c-3292498f45ba 42806-159 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20150331 ANDA ANDA040600 Epic Pharma, LLC HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 42806-160_4fe0f556-973c-4d64-be5c-3292498f45ba 42806-160 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20150331 ANDA ANDA040602 Epic Pharma, LLC HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 42806-161_4fe0f556-973c-4d64-be5c-3292498f45ba 42806-161 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20150331 ANDA ANDA040604 Epic Pharma, LLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 42806-213_b98e6507-920d-4bdf-8053-644f1e2c5ff7 42806-213 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20160401 ANDA ANDA075965 Epic Pharma, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 42806-215_b98e6507-920d-4bdf-8053-644f1e2c5ff7 42806-215 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20160401 ANDA ANDA075965 Epic Pharma, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 42806-221_b98e6507-920d-4bdf-8053-644f1e2c5ff7 42806-221 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20160401 ANDA ANDA075965 Epic Pharma, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 42806-260_5fb0190f-1cd4-8f93-e053-2a91aa0aecf6 42806-260 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET ORAL 20170323 ANDA ANDA078012 Epic Pharma, LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 42806-263_1e8fd94b-fa25-405e-9164-12cb32c0b475 42806-263 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20140515 ANDA ANDA077169 Epic Pharma, LLC ISRADIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 42806-264_1e8fd94b-fa25-405e-9164-12cb32c0b475 42806-264 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20140515 ANDA ANDA077169 Epic Pharma, LLC ISRADIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 42806-312_0e032f95-b4b2-4257-8c81-5c8ed8b712bb 42806-312 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20161001 ANDA ANDA062269 Epic Pharma, LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 42806-313_1746b113-4ae3-433f-8bc2-a1e2a99d606d 42806-313 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20170313 ANDA ANDA090564 Epic Pharma, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 42806-314_1746b113-4ae3-433f-8bc2-a1e2a99d606d 42806-314 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20170313 ANDA ANDA090564 Epic Pharma, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 42806-315_1746b113-4ae3-433f-8bc2-a1e2a99d606d 42806-315 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20170313 ANDA ANDA090564 Epic Pharma, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 42806-348_93a41d52-bb82-4aa4-96eb-ac3136ffc890 42806-348 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20171001 ANDA ANDA207224 Epic Pharma, LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 42806-349_93a41d52-bb82-4aa4-96eb-ac3136ffc890 42806-349 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20171001 ANDA ANDA207224 Epic Pharma, LLC BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 42806-501_262af531-f6c3-4931-bb1b-a7e6e4eb6639 42806-501 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride CAPSULE ORAL 20100505 ANDA ANDA074928 Epic Pharma, LLC NICARDIPINE HYDROCHLORIDE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 42806-502_262af531-f6c3-4931-bb1b-a7e6e4eb6639 42806-502 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride CAPSULE ORAL 20100505 ANDA ANDA074928 Epic Pharma, LLC NICARDIPINE HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 42806-503_601508de-d9ce-8d4c-e053-2991aa0a89a5 42806-503 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20100716 ANDA ANDA075517 Epic Pharma, LLC URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 42806-509_716fad35-d776-4a75-8de1-e1f57b74eeaf 42806-509 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170324 ANDA ANDA207099 Epic Pharma, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 42806-510_716fad35-d776-4a75-8de1-e1f57b74eeaf 42806-510 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170324 ANDA ANDA207099 Epic Pharma, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 42806-511_716fad35-d776-4a75-8de1-e1f57b74eeaf 42806-511 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170324 ANDA ANDA207099 Epic Pharma, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 42806-524_72e24e24-b0bd-40f8-a033-ab50f51292b2 42806-524 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE ORAL 20150415 ANDA ANDA040228 Epic Pharma, LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 42806-549_2ee1eef5-8ec7-46c1-b4fa-13184915448f 42806-549 HUMAN PRESCRIPTION DRUG Dutasteride Dutasteride CAPSULE, LIQUID FILLED ORAL 20171128 ANDA ANDA209909 Epic Pharma, LLC DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 42806-648_92732b8c-9804-4019-bd6c-5cc5077b1b0e 42806-648 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20161122 OTC MONOGRAPH FINAL part341 Epic Pharma, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 42806-649_4884641f-c4af-4148-89c1-0e29c6ec6e5e 42806-649 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20161122 OTC MONOGRAPH FINAL part341 Epic Pharma, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 42808-100_0d92c55b-5b54-4f5d-8921-24e4e877ae50 42808-100 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE SODIUM SULFACETAMIDE LIQUID TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 42808-102_4236f8a6-9866-4af4-89db-d32c911d88c0 42808-102 HUMAN PRESCRIPTION DRUG Exact-Rx Sodium Sulfacetamide Wash 10% SODIUM SULFACETAMIDE LIQUID TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 42808-103_47bf078b-9c1c-4bb4-901b-fffc02b2cf72 42808-103 HUMAN PRESCRIPTION DRUG Exact-Rx Sodium Sulfacetamide Wash 10% SODIUM SULFACETAMIDE LIQUID TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 42808-110_c9566966-0df9-4c60-a42e-522b429ca4b5 42808-110 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE, SULFUR SODIUM SULFACETAMIDE, SULFUR SOLUTION TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 42808-113_45018dc0-c96c-4ca0-bfe7-88334c37c844 42808-113 HUMAN PRESCRIPTION DRUG Exact-Rx SODIUM SULFACETAMIDE and SULFER 10%/5% Cleanser SODIUM SULFACETAMIDE, SULFUR LOTION TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 42808-200_24efe107-ea9a-4ba3-bd2f-769e1e31a02c 42808-200 HUMAN PRESCRIPTION DRUG Urea Urea CREAM TOPICAL 20110801 20180930 UNAPPROVED DRUG OTHER Exact-Rx, Inc. UREA 500 mg/g N 20181231 42808-202_e4516083-fb4d-4550-a6d7-31fb5bb93a24 42808-202 HUMAN PRESCRIPTION DRUG UREA UREA CREAM TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. UREA 450 mg/g N 20181231 42808-204_b58e175d-60e8-4206-ac7a-c67b68ac80f0 42808-204 HUMAN PRESCRIPTION DRUG Urea Urea GEL TOPICAL 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. UREA 450 mg/mL N 20181231 42808-205_420d1a2d-a629-458f-8bb5-13e796dabb3c 42808-205 HUMAN PRESCRIPTION DRUG Urea Urea EMULSION TOPICAL 20110801 20180630 UNAPPROVED DRUG OTHER Exact-Rx, Inc. UREA 500 mg/mL N 20181231 42808-399_129ccc6e-4eb2-495d-8583-427cb223b783 42808-399 HUMAN PRESCRIPTION DRUG Salicylic Acid SALICYLIC ACID KIT 20110801 UNAPPROVED DRUG OTHER Exact-Rx, Inc. E 20171231 42808-405_86aa8197-a2f1-439a-8110-1f09ce2e2e2a 42808-405 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20120112 20180531 ANDA ANDA040547 Exact-Rx, Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 42809-0002_71f45642-dc4b-48cd-bdb4-162cfa4918d4 42809-0002 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Express Medical Inc OXYGEN 99 L/100L N 20181231 42821-001_ff167c6a-a6cd-49c5-94f7-2d713e78e6a3 42821-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19000101 NDA NDA205767 T & C Flynn's Pharmacy Inc OXYGEN 990 mL/L N 20181231 42825-100_e6f3adb8-c116-4124-acdd-3f2283edc79d 42825-100 HUMAN OTC DRUG Aloe Scent A B Hand Sanitizing ALCOHOL SPRAY TOPICAL 20100625 OTC MONOGRAPH FINAL part333 Custom HBC Corporation ALCOHOL 62 mL/100mL N 20181231 42829-401_4cc4adc9-f191-4c93-8faa-47089fe825d1 42829-401 HUMAN OTC DRUG SinuCleanse SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION NASAL 20150201 UNAPPROVED DRUG OTHER ASCENT CONSUMER PRODUCTS, INC. SODIUM BICARBONATE; SODIUM CHLORIDE 700; 2300 mg/3000mg; mg/3000mg N 20181231 42829-402_446449bc-b944-4778-a094-f722c1d83bf0 42829-402 HUMAN OTC DRUG SinuCleanse Neti-Pot SODIUM BICARBONATE, SODIUM CHLORIDE KIT NASAL 20150201 UNAPPROVED DRUG OTHER ASCENT CONSUMER PRODUCTS, INC. N 20181231 42829-405_4a79a305-0f43-47f0-96c2-00af3dd211b8 42829-405 HUMAN OTC DRUG SinuCleanse Squeeze SODIUM BICARBONATE, SODIUM CHLORIDE KIT NASAL 20150201 UNAPPROVED DRUG OTHER ASCENT CONSUMER PRODUCTS, INC. N 20181231 42829-406_48cc46c5-dc45-4dac-adcf-2b28e78b80bb 42829-406 HUMAN OTC DRUG SinuCleanse Micro-Filtered Nasal Wash System Sodium Chloride, Sodium Bicarbonate KIT 20150701 UNAPPROVED DRUG OTHER ASCENT CONSUMER PRODUCTS, INC. N 20181231 42829-408_6878c19e-86d4-44ad-9b81-279dfbb74f16 42829-408 HUMAN OTC DRUG SinuCleanse SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION NASAL 20150201 UNAPPROVED DRUG OTHER ASCENT CONSUMER PRODUCTS, INC. SODIUM BICARBONATE; SODIUM CHLORIDE 22.2; 77.8 mg/100mg; mg/100mg N 20181231 42829-408_825f47bc-ef89-482d-b810-b21fec860152 42829-408 HUMAN OTC DRUG SinuCleanse SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION NASAL 20150201 UNAPPROVED DRUG OTHER ASCENT CONSUMER PRODUCTS, INC. SODIUM BICARBONATE; SODIUM CHLORIDE 22.2; 77.8 mg/100mg; mg/100mg N 20181231 42843-501_ff8c0119-caff-432c-a447-625547599e7e 42843-501 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate Brimonidine Tartrate SOLUTION/ DROPS OPHTHALMIC 20150101 ANDA ANDA091691 Osmotica Pharmaceutical Corp. BRIMONIDINE TARTRATE 2 mg/mg Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 42847-103_5205d855-ccf4-4d3f-be11-bda7476a62a3 42847-103 HUMAN PRESCRIPTION DRUG Silenor doxepin hydrochloride TABLET ORAL 20100801 NDA NDA022036 Pernix Therapeutics, LLC DOXEPIN HYDROCHLORIDE 3 mg/1 Tricyclic Antidepressant [EPC] N 20191231 42847-106_5205d855-ccf4-4d3f-be11-bda7476a62a3 42847-106 HUMAN PRESCRIPTION DRUG Silenor doxepin hydrochloride TABLET ORAL 20100801 NDA NDA022036 Pernix Therapeutics, LLC DOXEPIN HYDROCHLORIDE 6 mg/1 Tricyclic Antidepressant [EPC] N 20191231 42851-011_550280c4-06b4-4c94-941d-1fde920a5d44 42851-011 HUMAN PRESCRIPTION DRUG ZO COMPLEX A Tretinoin (Emollient) Tretinoin CREAM TOPICAL 20170501 ANDA ANDA076498 ZO Skin Health, Inc. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 42851-012_dd1ac198-c671-4e63-9bce-6105da019cb7 42851-012 HUMAN PRESCRIPTION DRUG Refissa Tretinoin (Emollient) Tretinoin CREAM TOPICAL 20170403 ANDA ANDA076498 ZO Skin Health, Inc. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 42851-030_d0f0ed2a-0557-4dff-ad6d-4ace56805e2a 42851-030 HUMAN PRESCRIPTION DRUG MELAMIN Skin Bleaching and Correcting Hydroquinone CREAM TOPICAL 20120101 UNAPPROVED DRUG OTHER ZO Skin Health, Inc. HYDROQUINONE .04 g/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 42851-031_cd0910a6-6a79-437e-bc91-00e7f13cc61a 42851-031 HUMAN PRESCRIPTION DRUG MELAMIX Skin Lightener and Blending Hydroquinone CREAM TOPICAL 20120101 UNAPPROVED DRUG OTHER ZO Skin Health, Inc. HYDROQUINONE .04 g/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 42851-032_d2083da3-67bd-4f36-a105-a088a50dd5e0 42851-032 HUMAN PRESCRIPTION DRUG MELAMIN Skin Bleaching and Correcting Hydroquinone HYDROQUINONE CREAM TOPICAL 20140701 UNAPPROVED DRUG OTHER ZO Skin Health, Inc. HYDROQUINONE .04 g/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 42851-033_bd7c76fb-1809-4600-8cac-d2a104880fe9 42851-033 HUMAN PRESCRIPTION DRUG MELAMIX Skin Lightener and Blending HYDROQUINONE CREAM TOPICAL 20140701 UNAPPROVED DRUG OTHER ZO Skin Health, Inc. HYDROQUINONE .04 g/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 42851-050_ca1cf074-eae6-4a2d-8beb-a88dcbaa9ba5 42851-050 HUMAN OTC DRUG ORASER DAILY HAND REPAIR Broad-Spectrum SPF 20 Sunscreen Avobenzone, Octinoxate, and Oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 30; 75; 20 mg/mL; mg/mL; mg/mL N 20181231 42851-051_0a6a88c6-e444-4bd6-beb1-0fe7a05ed841 42851-051 HUMAN OTC DRUG OCLIPSE Sunscreen plus Primer Broad-Spectrum SPF 30 UVA/UVB Protection Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. TITANIUM DIOXIDE; ZINC OXIDE 102; 37 mg/mL; mg/mL N 20181231 42851-052_b6d7357e-fb39-49c7-a081-23793e7298ce 42851-052 HUMAN OTC DRUG ZO MEDICAL OCLIPSE-C Broad-Spectrum Sunscreen SPF 50 Titanium Dioxide LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. TITANIUM DIOXIDE .08 g/g N 20181231 42851-053_b74ece5b-788e-4857-a0e4-589ef976db88 42851-053 HUMAN OTC DRUG ZO SKIN HEALTH OCLIPSE Sunscreen plus Primer Broad-Spectrum SPF 30 UVA/UVB Protection TITANIUM DIOXIDE LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. TITANIUM DIOXIDE 82 mg/mL N 20181231 42851-054_4021134c-fa79-4c93-93c3-055833e58801 42851-054 HUMAN OTC DRUG ZO SKIN HEALTH OCLIPSE SUN SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE PLUS BODY WATER/PERSPIRATION RESISTANT (80 minutes) AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE AEROSOL, SPRAY TOPICAL 20150401 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 150; 50; 100 g/mL; g/mL; g/mL; g/mL N 20181231 42851-055_738c782e-7ab2-47bd-bede-6783aad9f433 42851-055 HUMAN OTC DRUG ZO SKIN HEALTH OCLIPSE SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE LOTION TOPICAL 20150401 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42851-057_0847205a-e828-4e29-b7e6-2b5c462fe3d6 42851-057 HUMAN OTC DRUG ZO SKIN HEALTH OCLIPSE SUN SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE PLUS BODY WATER/PERSPIRATION RESISTANT (80 minutes) UVA / UVB / HEV / IR-A PROTECTION ZOX12 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, and OCTOCRYLENE AEROSOL, SPRAY TOPICAL 20160601 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 50; 100 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 42851-058_27ca1ec2-690b-4152-a468-0ce7003f656f 42851-058 HUMAN OTC DRUG ZO MEDICAL OCLIPSE-C Broad-Spectrum Sunscreen SPF 50 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20170201 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. TITANIUM DIOXIDE; ZINC OXIDE 57; 49 mg/g; mg/g N 20181231 42851-059_d14fce2b-4cd2-46ad-b9e0-9d608ea1d966 42851-059 HUMAN OTC DRUG ZO SKIN HEALTH OCLIPSE DAILY SHEER BROAD-SPECTRUM SUNSCREEN SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20161101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42851-070_5074a9ce-879a-4304-a593-964416c018bb 42851-070 HUMAN OTC DRUG AKNETROL Acne Treatment Benzoyl Peroxide LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. BENZOYL PEROXIDE 100 mg/mL N 20181231 42851-071_a93baf6e-24e9-4e5a-a387-a398f37192a8 42851-071 HUMAN OTC DRUG CEBATROL Oil Control Pads SALICYLIC ACID SOLUTION TOPICAL 20120101 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. SALICYLIC ACID 20 mg/mL N 20181231 42851-072_a3e267e5-39f5-400c-9133-efb2528df55e 42851-072 HUMAN OTC DRUG ZO MEDICAL AKNEBRIGHT Acne Spot and Pigmentation Treatment SALICYLIC ACID GEL TOPICAL 20141103 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. SALICYLIC ACID 20 mg/mL N 20181231 42851-073_27adbddb-6e78-40e2-8262-886707537fac 42851-073 HUMAN OTC DRUG ZO SKIN HEALTH OFFECTS SULFUR MASQUE ACNE TREATMENT SULFUR CREAM TOPICAL 20150501 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. SULFUR 100 mg/g N 20181231 42851-074_9271edb5-ff0a-4130-b3ef-804dd1b196d6 42851-074 HUMAN OTC DRUG ZO SKIN HEALTH OFFECTS CORRECT and CONCEAL ACNE TREATMENT (MEDIUM) SALICYLIC ACID STICK TOPICAL 20160101 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. SALICYLIC ACID 20 mg/g N 20181231 42851-075_a93baf6e-24e9-4e5a-a387-a398f37192a8 42851-075 HUMAN OTC DRUG ZO MEDICAL CEBATROL Oil Control Pads Acne Treatment SALICYLIC ACID SOLUTION TOPICAL 20150401 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. SALICYLIC ACID 20 mg/mL N 20181231 42851-076_64673f52-1817-4656-b8f2-ccfbbe395c06 42851-076 HUMAN OTC DRUG ZO SKIN HEALTH OFFECTS CORRECT and CONCEAL ACNE TREATMENT (LIGHT) SALICYLIC ACID STICK TOPICAL 20160101 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. SALICYLIC ACID 20 mg/g N 20181231 42851-078_5afe8e6c-f64e-4711-9977-96d9660d5312 42851-078 HUMAN OTC DRUG OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM SALICYLIC ACID SOLUTION TOPICAL 20110101 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. SALICYLIC ACID 20 mg/mL N 20181231 42851-079_5afe8e6c-f64e-4711-9977-96d9660d5312 42851-079 HUMAN OTC DRUG OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM SALICYLIC ACID SOLUTION TOPICAL 20150405 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. SALICYLIC ACID 20 mg/mL N 20181231 42851-080_03c14726-3520-4e3f-ae42-dfd9b4c46d3e 42851-080 HUMAN OTC DRUG ZO MEDICAL REGENACELL Epidermal Repair Creme Skin Protectant OATMEAL LOTION TOPICAL 20141114 OTC MONOGRAPH FINAL part347 ZO Skin Health, Inc. OATMEAL 10 mg/mL N 20181231 42851-082_363a7bd9-46f3-4c39-97e3-6a29a696c2aa 42851-082 HUMAN OTC DRUG ZO MEDICAL ZO POST PROCEDURE RECOVERY SYSTEM ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE, and OATMEAL KIT 20141114 OTC MONOGRAPH FINAL part347 ZO Skin Health, Inc. N 20181231 42851-083_07c580a6-e0ec-4f1f-ba57-43c20752c9e3 42851-083 HUMAN OTC DRUG REVITATROL Epidermal Repair Skin Protectant OATMEAL LOTION TOPICAL 20160201 OTC MONOGRAPH FINAL part347 ZO Skin Health, Inc. OATMEAL 10 mg/mL N 20181231 42851-084_af2e1f39-b312-41f4-923c-18a4dff99e1f 42851-084 HUMAN OTC DRUG ZO MEDICAL SURFATROL Astringent Aluminum Acetate POWDER TOPICAL 20160801 OTC MONOGRAPH FINAL part347 ZO Skin Health, Inc. ALUMINUM ACETATE 4866 mg/4.866g N 20181231 42851-131_b0663495-13e3-474a-ada0-eba342861340 42851-131 HUMAN PRESCRIPTION DRUG ZO MEDICAL ZO MULTI-THERAPY HYDROQUINONE SYSTEM Hydroquinone and Titanium Dioxide KIT 20140301 UNAPPROVED DRUG OTHER ZO Skin Health, Inc. N 20181231 42851-151_a0d48f61-26c5-4190-a6f7-32f98e0b2e2b 42851-151 HUMAN OTC DRUG ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM Correct, protect and prevent aging hands AVOBENZONE, OCTINOXATE, and OXYBENZONE KIT 20130301 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-152_c7e76e3e-a107-49f5-b32e-de5d9682cc6e 42851-152 HUMAN OTC DRUG ZO SKIN HEALTH LEVEL I DAILY SKINCARE PROGRAM Essentials for Healthy Skin TITANIUM DIOXIDE AND ZINC OXIDE KIT 20120101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-153_4c425570-8195-4691-a8ec-6f121328d64e 42851-153 HUMAN OTC DRUG ZO SKIN HEALTH LEVEL II ANTI-AGING PROGRAM with Growth Factor Serum Plus Titanium Dioxide and Zinc Oxide KIT 20120111 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-154_ce971d5b-db59-4534-9594-9c64c541bc50 42851-154 HUMAN OTC DRUG ZO SKIN HEALTH LEVEL III AGGRESSIVE ANTI-AGING PROGRAM with Advanced Radical Night Repair Titanium Dioxide and Zinc Oxide KIT 20120111 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-155_f74e99ed-574f-46d5-bda5-c5cf16c674b5 42851-155 HUMAN OTC DRUG ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA and OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION TITANIUM DIOXIDE and ZINC OXIDE KIT 20120101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-156_4387cf33-c883-4d48-8996-3c1b7e439804 42851-156 HUMAN OTC DRUG ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Restoring Even Skin Tone TITANIUM DIOXIDE KIT 20140501 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-157_087bd906-1a09-47ef-86b0-6201dbf75b64 42851-157 HUMAN OTC DRUG ZO SKIN HEALTH SunSmart Triple Protection Program Natural Melanin and Antioxidant Defenders with Sunscreen plus Primer SPF 30 TITANIUM DIOXIDE and ZINC OXIDE KIT 20140501 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-158_50473cf6-b9d0-4865-8767-358eb8b79808 42851-158 HUMAN OTC DRUG ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Skin Brightening Titanium Dioxide KIT 20151101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-162_d3e4a600-bc30-4e52-be1c-305592c95518 42851-162 HUMAN OTC DRUG ZO Skin Health ZO Favorites (Mothers Day GWP) Titanium Dioxide KIT 20150401 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-163_82bf8647-6740-4be5-ba71-f918a0a91b0d 42851-163 HUMAN OTC DRUG ZO SKIN HEALTH RENEW Titanium Dioxide KIT 20151201 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-166_b046610a-2032-40f5-bc8a-79481daa4aae 42851-166 HUMAN OTC DRUG ZO SKIN HEALTH Daily Skincare Program Titanium Dioxide KIT 20171101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-167_a54a7b52-944b-4639-a323-c19a7cb30e4e 42851-167 HUMAN OTC DRUG ZO Skin Health Anti-Aging Program Titanium Dioxide KIT 20171101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-168_79860529-de85-4e00-a589-009836e8dcda 42851-168 HUMAN OTC DRUG ZO SKIN HEALTH Aggressive Anti-Aging Program Titanium Dioxide KIT 20171101 OTC MONOGRAPH FINAL part352 ZO Skin Health, Inc. N 20181231 42851-172_72cb67ed-36ab-49a7-9a24-4a7180b924a8 42851-172 HUMAN OTC DRUG ZO SKIN HEALTH GSR (Getting Skin Ready) SYSTEM SALICYLIC ACID KIT 20110101 OTC MONOGRAPH FINAL part333D ZO Skin Health, Inc. N 20181231 42852-001_e846c0f9-f552-4f43-92f4-8541668912af 42852-001 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20110701 ANDA ANDA075593 Apothecary Shop Wholesale Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 42852-002_0cf70670-7217-46be-9a64-27beb7b9d02b 42852-002 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20110701 ANDA ANDA065095 Apothecary Shop Wholesale Inc. DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 42852-003_c78e92fe-c381-4afa-b221-c03cc5e391d7 42852-003 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20110701 ANDA ANDA076077 Apothecary Shop Wholesale Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 42853-102_2c3257ea-c42e-43ec-b1ec-755e9dd7b6f3 42853-102 HUMAN OTC DRUG ALL-IN-ONE BENZOYL PEROXIDE CREAM TOPICAL 20120225 OTC MONOGRAPH FINAL part333D AUGUSTUS BIOMED LLC BENZOYL PEROXIDE 5.5 g/100mL E 20171231 42856-001_a70f020f-24f1-4db8-b6f2-9fa27fd71594 42856-001 HUMAN OTC DRUG Antibacterial Wet Wipes Triclosan SWAB TOPICAL 20120312 OTC MONOGRAPH NOT FINAL part333A MAKESELLER GROUP INC. TRICLOSAN .2 g/100g E 20171231 42858-001_23807369-55e2-4a4c-a2b8-037545e702cb 42858-001 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140908 ANDA ANDA091490 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-002_23807369-55e2-4a4c-a2b8-037545e702cb 42858-002 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140908 ANDA ANDA091490 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-003_23807369-55e2-4a4c-a2b8-037545e702cb 42858-003 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140908 ANDA ANDA091490 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-004_23807369-55e2-4a4c-a2b8-037545e702cb 42858-004 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140908 ANDA ANDA091490 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-005_23807369-55e2-4a4c-a2b8-037545e702cb 42858-005 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140908 ANDA ANDA091490 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-011_ce934441-5141-4fe9-9816-e7900b6ec222 42858-011 HUMAN PRESCRIPTION DRUG DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20171201 ANDA ANDA208756 Rhodes Pharmaceuticals L.P. DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 42858-067_9afa3c4d-3044-4301-ac8f-646e1ca6b08f 42858-067 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20170601 ANDA ANDA075753 Rhodes Pharmaceuticals L.P. FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 42858-102_ad85bf8d-cb69-40aa-9963-1ca0e421456c 42858-102 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20140828 ANDA ANDA201278 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-103_ad85bf8d-cb69-40aa-9963-1ca0e421456c 42858-103 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20140828 ANDA ANDA201278 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-104_ad85bf8d-cb69-40aa-9963-1ca0e421456c 42858-104 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20140828 ANDA ANDA201278 Rhodes Pharmaceuticals L.P. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-122_0508aca9-51c6-4c4f-b37f-48a82ab01590 42858-122 HUMAN PRESCRIPTION DRUG Dilaudid hydromorphone hydrochloride TABLET ORAL 20170515 NDA NDA019892 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-134_9afa3c4d-3044-4301-ac8f-646e1ca6b08f 42858-134 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20170601 ANDA ANDA075753 Rhodes Pharmaceuticals L.P. FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 42858-200_9afa3c4d-3044-4301-ac8f-646e1ca6b08f 42858-200 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20170601 ANDA ANDA075753 Rhodes Pharmaceuticals L.P. FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 42858-201_05dcf08e-343a-44ad-a595-27b345e89030 42858-201 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160412 ANDA ANDA202991 Rhodes Pharmaceuticals L.P. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 42858-202_05dcf08e-343a-44ad-a595-27b345e89030 42858-202 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160412 ANDA ANDA202991 Rhodes Pharmaceuticals L.P. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 42858-203_05dcf08e-343a-44ad-a595-27b345e89030 42858-203 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160412 ANDA ANDA202991 Rhodes Pharmaceuticals L.P. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 42858-225_ce934441-5141-4fe9-9816-e7900b6ec222 42858-225 HUMAN PRESCRIPTION DRUG DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20171201 ANDA ANDA208756 Rhodes Pharmaceuticals L.P. DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 42858-234_0508aca9-51c6-4c4f-b37f-48a82ab01590 42858-234 HUMAN PRESCRIPTION DRUG Dilaudid hydromorphone hydrochloride TABLET ORAL 20170515 NDA NDA019892 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-301_4de0d911-285b-4d8d-bdd5-347635d02d2c 42858-301 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091123 NDA AUTHORIZED GENERIC NDA019892 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-302_4de0d911-285b-4d8d-bdd5-347635d02d2c 42858-302 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091123 NDA AUTHORIZED GENERIC NDA019892 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-303_4de0d911-285b-4d8d-bdd5-347635d02d2c 42858-303 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091123 NDA AUTHORIZED GENERIC NDA019892 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-304_4de0d911-285b-4d8d-bdd5-347635d02d2c 42858-304 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride SOLUTION ORAL 20120720 NDA AUTHORIZED GENERIC NDA019891 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-338_0508aca9-51c6-4c4f-b37f-48a82ab01590 42858-338 HUMAN PRESCRIPTION DRUG Dilaudid hydromorphone hydrochloride TABLET ORAL 20170515 NDA NDA019892 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-353_92e7b0a3-c4ab-45b8-b730-654e195f693e 42858-353 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine PATCH TRANSDERMAL 20170703 NDA AUTHORIZED GENERIC NDA021306 Rhodes Pharmaceuticals L.P. BUPRENORPHINE 7.5 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 42858-401_bcc0d774-36e7-4085-9349-46177533fdf2 42858-401 HUMAN PRESCRIPTION DRUG APTENSIO XR (methylphenidate hydrochloride) CAPSULE, EXTENDED RELEASE ORAL 20150417 NDA NDA205831 Rhodes Pharmaceuticals L.P. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 42858-402_bcc0d774-36e7-4085-9349-46177533fdf2 42858-402 HUMAN PRESCRIPTION DRUG APTENSIO XR (methylphenidate hydrochloride) CAPSULE, EXTENDED RELEASE ORAL 20150417 NDA NDA205831 Rhodes Pharmaceuticals L.P. METHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 42858-403_bcc0d774-36e7-4085-9349-46177533fdf2 42858-403 HUMAN PRESCRIPTION DRUG APTENSIO XR (methylphenidate hydrochloride) CAPSULE, EXTENDED RELEASE ORAL 20150417 NDA NDA205831 Rhodes Pharmaceuticals L.P. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 42858-404_bcc0d774-36e7-4085-9349-46177533fdf2 42858-404 HUMAN PRESCRIPTION DRUG APTENSIO XR (methylphenidate hydrochloride) CAPSULE, EXTENDED RELEASE ORAL 20150417 NDA NDA205831 Rhodes Pharmaceuticals L.P. METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 42858-405_bcc0d774-36e7-4085-9349-46177533fdf2 42858-405 HUMAN PRESCRIPTION DRUG APTENSIO XR (methylphenidate hydrochloride) CAPSULE, EXTENDED RELEASE ORAL 20150417 NDA NDA205831 Rhodes Pharmaceuticals L.P. METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 42858-406_bcc0d774-36e7-4085-9349-46177533fdf2 42858-406 HUMAN PRESCRIPTION DRUG APTENSIO XR (methylphenidate hydrochloride) CAPSULE, EXTENDED RELEASE ORAL 20150417 NDA NDA205831 Rhodes Pharmaceuticals L.P. METHYLPHENIDATE HYDROCHLORIDE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 42858-407_bcc0d774-36e7-4085-9349-46177533fdf2 42858-407 HUMAN PRESCRIPTION DRUG APTENSIO XR (methylphenidate hydrochloride) CAPSULE, EXTENDED RELEASE ORAL 20150417 NDA NDA205831 Rhodes Pharmaceuticals L.P. METHYLPHENIDATE HYDROCHLORIDE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 42858-410_ce934441-5141-4fe9-9816-e7900b6ec222 42858-410 HUMAN PRESCRIPTION DRUG DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20171201 ANDA ANDA208756 Rhodes Pharmaceuticals L.P. DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 42858-416_0508aca9-51c6-4c4f-b37f-48a82ab01590 42858-416 HUMAN PRESCRIPTION DRUG Dilaudid hydromorphone hydrochloride SOLUTION ORAL 20170515 NDA NDA019891 Rhodes Pharmaceuticals L.P. HYDROMORPHONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-454_2f35bd58-4ec3-4b09-b17c-e9c410b3785e 42858-454 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20170601 ANDA ANDA076433 Rhodes Pharmaceuticals L.P. FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 42858-493_92e7b0a3-c4ab-45b8-b730-654e195f693e 42858-493 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine PATCH TRANSDERMAL 20170703 NDA AUTHORIZED GENERIC NDA021306 Rhodes Pharmaceuticals L.P. BUPRENORPHINE 10 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 42858-501_1dde731b-3af7-4b1d-b6a5-c3ddc0d9e3f0 42858-501 HUMAN PRESCRIPTION DRUG BUPRENORPHINE BUPRENORPHINE TABLET SUBLINGUAL 20171025 ANDA ANDA207276 Rhodes Pharmaceuticals L.P. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 42858-502_1dde731b-3af7-4b1d-b6a5-c3ddc0d9e3f0 42858-502 HUMAN PRESCRIPTION DRUG BUPRENORPHINE BUPRENORPHINE TABLET SUBLINGUAL 20171025 ANDA ANDA207276 Rhodes Pharmaceuticals L.P. BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 42858-515_182326e4-42e5-40b6-b1c6-166204952caf 42858-515 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET ORAL 20170515 NDA NDA019516 Rhodes Pharmaceuticals L.P. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-586_92e7b0a3-c4ab-45b8-b730-654e195f693e 42858-586 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine PATCH TRANSDERMAL 20170703 NDA AUTHORIZED GENERIC NDA021306 Rhodes Pharmaceuticals L.P. BUPRENORPHINE 15 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 42858-631_182326e4-42e5-40b6-b1c6-166204952caf 42858-631 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET ORAL 20170515 NDA NDA019516 Rhodes Pharmaceuticals L.P. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-660_2f35bd58-4ec3-4b09-b17c-e9c410b3785e 42858-660 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20170601 ANDA ANDA076433 Rhodes Pharmaceuticals L.P. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 42858-701_55e1fcf1-5029-487d-b5f5-cf095ef6466b 42858-701 HUMAN PRESCRIPTION DRUG Theophylline Anhydrous Theophylline TABLET, EXTENDED RELEASE ORAL 20120202 ANDA ANDA087571 Rhodes Pharmaceuticals L.P. THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 42858-702_55e1fcf1-5029-487d-b5f5-cf095ef6466b 42858-702 HUMAN PRESCRIPTION DRUG Theophylline Anhydrous Theophylline TABLET, EXTENDED RELEASE ORAL 20120202 ANDA ANDA040086 Rhodes Pharmaceuticals L.P. THEOPHYLLINE ANHYDROUS 600 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 42858-750_92e7b0a3-c4ab-45b8-b730-654e195f693e 42858-750 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine PATCH TRANSDERMAL 20170703 NDA AUTHORIZED GENERIC NDA021306 Rhodes Pharmaceuticals L.P. BUPRENORPHINE 5 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 42858-760_182326e4-42e5-40b6-b1c6-166204952caf 42858-760 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET ORAL 20170515 NDA NDA019516 Rhodes Pharmaceuticals L.P. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-799_182326e4-42e5-40b6-b1c6-166204952caf 42858-799 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET ORAL 20170515 NDA NDA019516 Rhodes Pharmaceuticals L.P. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-801_774243f8-11f7-4519-8abd-b8b5c90d7350 42858-801 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Rhodes Pharmaceuticals L. P. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-802_774243f8-11f7-4519-8abd-b8b5c90d7350 42858-802 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Rhodes Pharmaceuticals L. P. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-803_774243f8-11f7-4519-8abd-b8b5c90d7350 42858-803 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Rhodes Pharmaceuticals L. P. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-804_774243f8-11f7-4519-8abd-b8b5c90d7350 42858-804 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074769 Rhodes Pharmaceuticals L. P. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-805_774243f8-11f7-4519-8abd-b8b5c90d7350 42858-805 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074769 Rhodes Pharmaceuticals L. P. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-810_4b29db2e-d507-4739-ab6d-a7fdcd3279c2 42858-810 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20170622 ANDA ANDA206308 Rhodes Pharmaceuticals L.P. MORPHINE SULFATE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-811_4b29db2e-d507-4739-ab6d-a7fdcd3279c2 42858-811 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20160712 ANDA ANDA206420 Rhodes Pharmaceuticals L.P. MORPHINE SULFATE 20 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-812_4b29db2e-d507-4739-ab6d-a7fdcd3279c2 42858-812 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20170622 ANDA ANDA206308 Rhodes Pharmaceuticals L.P. MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42858-839_92e7b0a3-c4ab-45b8-b730-654e195f693e 42858-839 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine PATCH TRANSDERMAL 20170703 NDA AUTHORIZED GENERIC NDA021306 Rhodes Pharmaceuticals L.P. BUPRENORPHINE 20 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 42858-900_182326e4-42e5-40b6-b1c6-166204952caf 42858-900 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET ORAL 20170515 NDA NDA019516 Rhodes Pharmaceuticals L.P. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 42865-300_89b1dff9-305f-4b04-bffa-bfcecabd8056 42865-300 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20140325 NDA NDA022210 Allergan PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 5000; 17000; 27000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 42865-302_89b1dff9-305f-4b04-bffa-bfcecabd8056 42865-302 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20140325 NDA NDA022210 Allergan PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 15000; 51000; 82000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 42865-303_89b1dff9-305f-4b04-bffa-bfcecabd8056 42865-303 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20140325 NDA NDA022210 Allergan PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 20000; 68000; 109000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 42865-304_89b1dff9-305f-4b04-bffa-bfcecabd8056 42865-304 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20140325 NDA NDA022210 Allergan PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 3000; 10000; 16000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 42865-305_89b1dff9-305f-4b04-bffa-bfcecabd8056 42865-305 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20110719 NDA NDA022210 Allergan PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 25000; 85000; 136000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 42865-306_89b1dff9-305f-4b04-bffa-bfcecabd8056 42865-306 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20140325 NDA NDA022210 Allergan PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 10000; 34000; 55000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 42865-307_89b1dff9-305f-4b04-bffa-bfcecabd8056 42865-307 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20140325 NDA NDA022210 Allergan PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 40000; 136000; 218000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 42869-801_225b0397-7d91-427e-80dc-cda6cfa04328 42869-801 HUMAN OTC DRUG Alcohol Wipes Alcohol CLOTH TOPICAL 20150828 OTC MONOGRAPH NOT FINAL part333E Jiangmen Nowadays Daily Goods Co., Ltd. ALCOHOL .31 mL/mL E 20171231 42869-802_1f7ec3cf-2dfb-4c75-bce5-5d4e29137fa3 42869-802 HUMAN OTC DRUG Freeman Packaging Hand Sanitizer ALCOHOL LIQUID TOPICAL 20150828 OTC MONOGRAPH NOT FINAL part333E Jiangmen Nowadays Daily Goods Co., Ltd. ALCOHOL 62 mL/100mL E 20171231 42869-803_1fe3a437-9492-441a-ae1b-7e69b5fb313d 42869-803 HUMAN OTC DRUG Alcohol Wipes Alcohol CLOTH TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part333E Jiangmen Nowadays Daily Goods Co., Ltd. ALCOHOL .62 mL/mL E 20171231 42869-804_0b47285c-5255-4ccf-8e58-b7bbb1ed0301 42869-804 HUMAN OTC DRUG Hand Wipes Chlorhexidine Digluconate and BENZETHONIUM CHLORIDE CLOTH TOPICAL 20150925 OTC MONOGRAPH NOT FINAL part333A Jiangmen Nowadays Daily Goods Co., Ltd. CHLORHEXIDINE GLUCONATE; BENZETHONIUM CHLORIDE .1; .08 g/g; g/g E 20171231 42869-806_0601c69b-dd22-421f-b609-0c08fce9a57f 42869-806 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LIQUID TOPICAL 20150828 OTC MONOGRAPH NOT FINAL part333E Jiangmen Nowadays Daily Goods Co., Ltd. ALCOHOL 62 g/100g E 20171231 42869-808_7172cdb6-41f4-45a6-86bb-cabfd9dbd541 42869-808 HUMAN OTC DRUG Germ SOS Sanitizing Wipes Alcohol CLOTH TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part333E Jiangmen Nowadays Daily Goods Co., Ltd. ALCOHOL .7 mL/mL E 20171231 42869-809_35252659-8a34-49b4-a2e2-687a3285fa71 42869-809 HUMAN OTC DRUG KidzStuff Hand Sanitizer ALCOHOL LIQUID TOPICAL 20170520 OTC MONOGRAPH NOT FINAL part333E Jiangmen Nowadays Daily Goods Co., Ltd. ALCOHOL 62 g/100g N 20181231 42874-012_e8aa934c-d74e-4c7c-b2fc-d3b8b46f4529 42874-012 VACCINE Flublok Influenza Vaccine INJECTION, SOLUTION INTRAMUSCULAR 20130201 BLA BLA125285 Protein Sciences Corporation INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/VICTORIA/361/2011 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/WISCONSIN/1/2010 RECOMBINANT HEMAGGLUTININ ANTIGEN 45; 45; 45 ug/.5mL; ug/.5mL; ug/.5mL E 20171231 42874-013_fb2aad7e-82d2-47c0-9eb3-08ac62641a47 42874-013 VACCINE Flublok Influenza Vaccine INJECTION, SOLUTION INTRAMUSCULAR 20131101 BLA BLA125285 Protein Sciences Corporation INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/TEXAS/50/2012 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 RECOMBINANT HEMAGGLUTININ ANTIGEN 45; 45; 45 ug/.5mL; ug/.5mL; ug/.5mL E 20171231 42874-014_831d38cc-1793-4de9-8176-46e7a9f60756 42874-014 VACCINE Flublok Influenza Vaccine INJECTION, SOLUTION INTRAMUSCULAR 20140915 BLA BLA125285 Protein Sciences Corporation INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/TEXAS/50/2012 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 RECOMBINANT HEMAGGLUTININ ANTIGEN 45; 45; 45 ug/.5mL; ug/.5mL; ug/.5mL E 20171231 42874-015_8fedde67-e645-4d69-90eb-c2af98bcc3ef 42874-015 VACCINE Flublok Influenza Vaccine INJECTION, SOLUTION INTRAMUSCULAR 20150807 BLA BLA125285 Protein Sciences Corporation INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN 45; 45; 45 ug/.5mL; ug/.5mL; ug/.5mL E 20171231 42874-016_fc8b76d7-97c4-4d1f-b96a-5cdb86edf40f 42874-016 VACCINE Flublok Influenza Vaccine INJECTION, SOLUTION INTRAMUSCULAR 20160801 BLA BLA125285 Protein Sciences Corporation INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/HONG KONG/4801/2014 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 RECOMBINANT HEMAGGLUTININ ANTIGEN 45; 45; 45 ug/.5mL; ug/.5mL; ug/.5mL E 20171231 42874-017_ce88cc84-b4ed-4d59-8897-10cb53dc2edf 42874-017 VACCINE Flublok Influenza Vaccine INJECTION, SOLUTION INTRAMUSCULAR 20170714 BLA BLA125285 Protein Sciences Corporation INFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/HONG KONG/4801/2014 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 RECOMBINANT HEMAGGLUTININ ANTIGEN 45; 45; 45 ug/.5mL; ug/.5mL; ug/.5mL N 20181231 42874-117_1888cce3-ebc7-44e2-84ab-5724c1a97ac6 42874-117 VACCINE Flublok Quadrivalent influenza vaccine INJECTION, SOLUTION INTRAMUSCULAR 20170714 20180630 BLA BLA125285 Protein Sciences Corporation INFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/HONG KONG/4801/2014 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN 45; 45; 45; 45 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL N 20181231 42876-001_5bcb429b-3625-439a-bc62-36c027f98e0c 42876-001 HUMAN OTC DRUG COMPLEXION CLEAR ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20120229 OTC MONOGRAPH FINAL part333D Results RNA, LLC SALICYLIC ACID 2 mL/100mL E 20171231 42876-002_347db891-4f8b-43d2-bb93-48325641bd85 42876-002 HUMAN OTC DRUG NEXICLEAR ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20120229 OTC MONOGRAPH FINAL part333D Results RNA, LLC SALICYLIC ACID 2 mL/100mL E 20171231 42876-003_346d76a9-106a-43cd-a24d-ccfe69fff8de 42876-003 HUMAN OTC DRUG Complexion Clear Acne Treatment Rejuvenating BENZOYL PEROXIDE CREAM TOPICAL 20121107 OTC MONOGRAPH FINAL part333D Results RNA, LLC BENZOYL PEROXIDE 25 mg/mL E 20171231 42877-001_968feffc-85c5-457e-a110-27001c8be572 42877-001 HUMAN OTC DRUG skin effects Firming Facial with Retinol Complex SPF 30 AVOBENZONE, OCTINOXATE,OCTISALATE CREAM TOPICAL 20110928 OTC MONOGRAPH NOT FINAL part352 Diversified Global Technologies DBA Diversified Distribution AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100g; g/100g; g/100g N 20181231 42877-002_280eb7c5-9b5f-4ff7-9b4a-81f9e177874f 42877-002 HUMAN OTC DRUG skin effects Brightening Day SPF 50 AVOBENZONE, HOMOSALATE, OCTINOXATE,OCTISALATE CREAM TOPICAL 20110928 OTC MONOGRAPH NOT FINAL part352 Diversified Global Technologies DBA Diversified Distribution AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 3; 15; 7.5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 42877-003_60dd6cd6-21bc-98dc-e053-2991aa0a828d 42877-003 HUMAN OTC DRUG CVS Advance Acne Therapy Kit SALICYLIC ACID, BENZOYL PEROXIDE KIT 20170118 OTC MONOGRAPH FINAL part333D Diversified Global Technologies, LLC N 20181231 42877-092_d1cc3eda-aefb-406a-8780-c3a864934e1e 42877-092 HUMAN OTC DRUG Skin Effects by Dr. Jeffrey Dover Glycolic Day HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20100629 OTC MONOGRAPH FINAL part352 Diversified Global Technologies DBA Diversified Distribution HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 10; 5; 5; 3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 42884-352_1dd4f4e4-4851-4b2b-b010-e7d138120744 42884-352 HUMAN OTC DRUG Zonnic Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20130503 ANDA ANDA078547 Niconovum USA Inc. NICOTINE 2 mg/1 N 20181231 42884-365_ac99bd9f-5c92-48de-93aa-2ac994f1a5af 42884-365 HUMAN OTC DRUG Zonnic Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20130503 ANDA ANDA091349 Niconovum USA Inc. NICOTINE 2 mg/1 N 20181231 42884-442_487b2aca-5c1a-43a7-89f9-3bee2d64fa45 42884-442 HUMAN OTC DRUG Zonnic Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20130503 ANDA ANDA091354 Niconovum USA Inc. NICOTINE 4 mg/1 N 20181231 42884-456_e76793bf-0e6a-4347-a27e-8409fe9c1e24 42884-456 HUMAN OTC DRUG zonnic nicotine polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20120625 ANDA ANDA076777 Niconovum USA Inc. NICOTINE 2 mg/1 N 20181231 42884-532_6cc93851-4abb-45c2-98f9-1d4b305b3ed3 42884-532 HUMAN OTC DRUG zonnic nicotine polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20120627 ANDA ANDA076779 Niconovum USA Inc. NICOTINE 4 mg/1 N 20181231 42884-734_5a733efa-52fc-4b2f-8082-f26c47069dfd 42884-734 HUMAN OTC DRUG Zonnic Nicotine Mini Nicotine Polacrilex LOZENGE ORAL 20160503 ANDA ANDA203690 Niconovum USA Inc. NICOTINE 2 mg/1 N 20181231 42884-854_7a3ba9bf-62e1-4762-b640-f0de22e83192 42884-854 HUMAN OTC DRUG Zonnic Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20130503 ANDA ANDA078546 Niconovum USA Inc. NICOTINE 4 mg/1 N 20181231 42884-957_636f036e-eb68-4ff6-9d50-a5feb57ba7b8 42884-957 HUMAN OTC DRUG zonnic Nicotine Polacrilex LOZENGE ORAL 20160509 ANDA ANDA203690 Niconovum USA Inc. NICOTINE 4 mg/1 N 20181231 42887-001_5fddde22-6598-7a7b-e053-2991aa0aa52f 42887-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20010101 UNAPPROVED MEDICAL GAS North Central Respiratory, Inc OXYGEN 99 L/100L N 20181231 42891-4148_6bb422ae-a560-4b6e-bd39-a2bd7b62227a 42891-4148 HUMAN OTC DRUG AVVA Benzalkonium chloride GEL VAGINAL 20120328 OTC MONOGRAPH NOT FINAL part333A AVVA International LLC BENZALKONIUM CHLORIDE 100 mg/100mL E 20171231 42893-011_6108c09a-8409-5d0f-e053-2991aa0a874a 42893-011 HUMAN OTC DRUG CHANTECAILLE Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TITANIUM DIOXIDE LOTION TOPICAL 20140717 OTC MONOGRAPH NOT FINAL part352 Chantecaille Beaute Inc TITANIUM DIOXIDE 10.157 g/100g N 20181231 42893-013_61094a33-a77b-5719-e053-2991aa0a131c 42893-013 HUMAN OTC DRUG CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part352 Chantecaille Beaute Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 27.5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 42903-003_6c42b121-7d93-4303-a125-bb871d9df77e 42903-003 HUMAN OTC DRUG LivSport Post-Workout Ruta CREAM TOPICAL 20120501 UNAPPROVED HOMEOPATHIC LivCorp Inc. RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/100g N 20181231 42903-004_4865eee5-743a-4eac-8534-fe4bce26a262 42903-004 HUMAN OTC DRUG LivSport PreWorkout with Heat Ruta, Rhus Tox, Arnica CREAM TOPICAL 20120501 UNAPPROVED HOMEOPATHIC LivCorp Inc. RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA 4; 8; 8 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g N 20181231 42903-008_44265ea9-9ab6-4ec8-8bf1-8e4965bf4538 42903-008 HUMAN OTC DRUG LivRelief Pain Relief Capsaicin CREAM TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part348 LivCorp Inc. CAPSAICIN .0375 g/50g N 20181231 42903-009_38f4d389-c0b9-4d21-a1af-7b8a46bef95a 42903-009 HUMAN OTC DRUG LivRelief Nerve Pain Relief Capsicum annuum CREAM TOPICAL 20150817 UNAPPROVED HOMEOPATHIC LivCorp Inc. CAPSICUM 2 [hp_C]/50g N 20181231 42906-001_318ffcab-7025-4fac-827b-cf6269facc12 42906-001 HUMAN OTC DRUG Liquid Nature Antibacterial Hand Soap Liquid Nature Antibacterial Hand Soap SOLUTION TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part333 VM Global Manufacturers Group Inc. TRICLOSAN .575 mL/500mL E 20171231 42912-0150_8a30d1bd-99cb-48e8-8618-64330fa05120 42912-0150 HUMAN OTC DRUG Lidocaine Maximum Strength Lidocaine PATCH TOPICAL 20170510 OTC MONOGRAPH NOT FINAL part348 TDS Pharm Co. Ltd LIDOCAINE 246 mg/1 N 20181231 42912-0152_896e0b77-09de-4832-9c3d-d273005e5b43 42912-0152 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part343 TDS Pharm Co., Ltd ACETAMINOPHEN 500 mg/1 E 20171231 42912-0153_896e0b77-09de-4832-9c3d-d273005e5b43 42912-0153 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100801 OTC MONOGRAPH NOT FINAL part343 TDS Pharm Co., Ltd ACETAMINOPHEN 500 mg/1 E 20171231 42912-0154_e47b7279-fe42-4741-86f2-62a998e8765d 42912-0154 HUMAN OTC DRUG Acetaminophen PM Acetaminophen, diphenhydramine HCl TABLET ORAL 20110128 OTC MONOGRAPH NOT FINAL part343 TDS Pharm Co., Ltd. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 42913-001_5a457bae-ba4e-6c01-e053-2991aa0a96ff 42913-001 HUMAN OTC DRUG Power Stick XJ Coolblast Xtreme ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g N 20181231 42913-006_1ea56037-42b6-4578-9cf9-835155d44649 42913-006 HUMAN OTC DRUG Power Stick XJ Intensity ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g N 20181231 42913-007_f39d7d80-9cfa-44d6-9d9a-bf6d8b3b6380 42913-007 HUMAN OTC DRUG XTREME Power Stick Ignition ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g N 20181231 42913-008_72ac7fca-d3b7-4f75-a717-c445196eaa8b 42913-008 HUMAN OTC DRUG Power Stick Powder Fresh ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g N 20181231 42913-009_e49e3077-1262-474d-bb70-bf77e2f96507 42913-009 HUMAN OTC DRUG Power Stick Shower Fresh ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g N 20181231 42913-010_a666614b-4e27-4dce-9f65-e7e3425bec7b 42913-010 HUMAN OTC DRUG Soft Whisper Cucumber Green Tea ALUMINUM SESQUICHLOROHYDRATE STICK TOPICAL 20141114 OTC MONOGRAPH FINAL part350 A.P. Deauville, LLC ALUMINUM SESQUICHLOROHYDRATE 200 mg/g N 20181231 42913-020_61469843-fa44-30c6-e053-2991aa0a201f 42913-020 HUMAN OTC DRUG Soft Whisper Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20171005 OTC MONOGRAPH FINAL part358H A.P. Deauville, LLC PYRITHIONE ZINC 10 mg/mL N 20181231 42914-001_5ed2209c-5ef6-4b16-a05d-55f2b10107af 42914-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20071215 NDA NDA205862 Aspen Air US Corp OXYGEN 99 L/100L N 20181231 42914-010_fc1817a8-1783-4f8a-95f3-f02fcb46a6f0 42914-010 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20071215 NDA NDA205863 Aspen Air US Corp NITROGEN 99 L/100L N 20181231 42924-001_2b874be3-14ab-4446-bab6-acd45c64bd7c 42924-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090218 UNAPPROVED MEDICAL GAS Terjan Co., Inc. DBA Valley Welding Supply Company OXYGEN 990 mL/L E 20171231 42924-002_5bfd9228-a248-46a0-9475-9999119bc62d 42924-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20100317 UNAPPROVED MEDICAL GAS Terjan Co., Inc. DBA Valley Welding Supply Company NITROGEN 990 mL/L E 20171231 42926-160_44e51d4f-42bb-0ec7-e054-00144ff88e88 42926-160 HUMAN OTC DRUG Pomegranate Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part333E Mangiacotti, Inc BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 42926-162_44e52be6-b3ba-0b37-e054-00144ff88e88 42926-162 HUMAN OTC DRUG Clementine Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part333E Mangiacotti, Inc BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 42926-163_44e51ea8-5dd1-0199-e054-00144ff8d46c 42926-163 HUMAN OTC DRUG Ocean Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part333E Mangiacotti, Inc BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 42926-164_44e51ea8-5ddd-0199-e054-00144ff8d46c 42926-164 HUMAN OTC DRUG Lavender Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part333E Mangiacotti, Inc BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 42926-165_44e52be6-b3ab-0b37-e054-00144ff88e88 42926-165 HUMAN OTC DRUG Lemon Verbena Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part333E Mangiacotti, Inc BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 42936-585_cc152a2c-326a-4b98-b10d-c87c3c69a432 42936-585 HUMAN OTC DRUG Foam San Hand Sanitizer ALCOHOL LIQUID TOPICAL 20080605 OTC MONOGRAPH NOT FINAL part333E Hill Manufacturing Co., Inc. ALCOHOL .62 mL/mL N 20181231 42937-701_578d1600-e1c1-4638-808b-54364af14137 42937-701 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, COATED ORAL 20110802 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 42937-702_578d1600-e1c1-4638-808b-54364af14137 42937-702 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, COATED ORAL 20110802 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 42937-703_9d53f29e-d218-480b-85ec-292842cdd4a4 42937-703 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20110819 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC SALSALATE 500 mg/1 N 20181231 42937-704_9d53f29e-d218-480b-85ec-292842cdd4a4 42937-704 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20110819 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC SALSALATE 750 mg/1 N 20181231 42937-705_a7970fac-c416-49cc-92bb-db6de4c27ac7 42937-705 HUMAN PRESCRIPTION DRUG Prenatal Plus Vitamin A, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Zinc Oxide, and Cupric Oxide TABLET ORAL 20110601 UNAPPROVED DRUG OTHER Nationwide Laboratories VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; IRON; ZINC OXIDE; CUPRIC OXIDE 4000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 29; 25; 2 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] E 20171231 42937-706_affd4f2c-932e-48b3-8c4c-2783988bb000 42937-706 HUMAN PRESCRIPTION DRUG PreNatal 19 .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, and DOCUSATE SODIUM TABLET, COATED ORAL 20130601 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; DOCUSATE SODIUM 1000; 100; 400; 30; 3; 3; 15; 20; 1; 12; 7; 200; 29; 20; 25 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] E 20171231 42937-707_2b977d29-5b8f-48d9-bcfa-f5a9666a3ae4 42937-707 HUMAN PRESCRIPTION DRUG PreNatal 19 FOLIC ACID, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, and ZINC OXIDE TABLET, CHEWABLE ORAL 20130601 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC FOLIC ACID; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE 1; 1000; 100; 400; 30; 3; 3; 15; 20; 12; 7; 200; 29; 20 mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] E 20171231 42937-711_bddfb778-4af8-4bb9-a2af-ee7de990d2e8 42937-711 HUMAN PRESCRIPTION DRUG Salicylic Acid Salicylic Acid CREAM TOPICAL 20170606 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC SALICYLIC ACID 6 g/100g N 20181231 42937-712_3b13a1ed-9430-4a53-80b2-eff9874d47f8 42937-712 HUMAN PRESCRIPTION DRUG Salicylic Acid Salicylic Acid LOTION TOPICAL 20170606 UNAPPROVED DRUG OTHER Nationwide Laboratories, LLC SALICYLIC ACID 6 g/100mL N 20181231 42939-124_3e3d351a-057c-1aeb-e054-00144ff8d46c 42939-124 HUMAN OTC DRUG Scrub, Scrub-Stat, Foam Safe, Micro-Guard Chlorhexidine gluconate SOLUTION TOPICAL 19860722 NDA NDA019258 AVA, Inc. CHLORHEXIDINE GLUCONATE 20 mg/mL N 20181231 42939-124_42b0a0a9-6c5f-45c7-e054-00144ff88e88 42939-124 HUMAN OTC DRUG Scrub, Scrub-Stat, Foam Safe, Micro-Guard Chlorhexidine gluconate SOLUTION TOPICAL 19860722 NDA NDA019258 AVA, Inc. CHLORHEXIDINE GLUCONATE 20 mg/mL N 20181231 42939-125_43401362-8e55-1f5d-e054-00144ff8d46c 42939-125 HUMAN OTC DRUG Scrub, Scrub-Stat, Foam Safe, Micro-Guard Chlorhexidine gluconate SOLUTION TOPICAL 19860722 NDA NDA019258 AVA, Inc. CHLORHEXIDINE GLUCONATE 40 mg/mL N 20181231 42939-125_43402281-927c-61aa-e054-00144ff88e88 42939-125 HUMAN OTC DRUG Scrub, Scrub-Stat, Foam Safe, Micro-Guard Chlorhexidine gluconate SOLUTION TOPICAL 19860722 NDA NDA019258 AVA, Inc. CHLORHEXIDINE GLUCONATE 40 mg/mL N 20181231 42939-127_3e379ccb-1ce9-2911-e054-00144ff88e88 42939-127 HUMAN OTC DRUG Scrub, Scrub-Stat, Foam Safe, Micro-Guard Chlorhexidine gluconate SOLUTION TOPICAL 19860722 NDA NDA019258 AVA, Inc. CHLORHEXIDINE GLUCONATE 20 mg/mL N 20181231 42939-128_44bb0556-ec3b-1978-e054-00144ff8d46c 42939-128 HUMAN OTC DRUG Scrub, Scrub-Stat, Foam Safe, Micro-Guard Chlorhexidine gluconate SOLUTION TOPICAL 19860722 NDA NDA019258 AVA, Inc. CHLORHEXIDINE GLUCONATE 40 mg/mL N 20181231 42947-500_dc6e411d-712f-4ec1-a513-cf4afbb49c9c 42947-500 HUMAN OTC DRUG VIAMED Alcohol Prep Pad ALCOHOL SWAB TOPICAL 20150910 OTC MONOGRAPH NOT FINAL part333E Wuxi Medical Instrument Factory ALCOHOL 70 g/100g E 20171231 42947-610_3285c92f-0faa-4a9c-a3be-d491c443ce55 42947-610 HUMAN OTC DRUG BZK Alcohol Benzalkonium Chloride SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory BENZALKONIUM CHLORIDE .0013 mL/mL N 20181231 42947-611_e4be2e4a-9da9-4bce-8201-f62894a85256 42947-611 HUMAN OTC DRUG Povidone-Iodine Prep Pad Povidone-Iodine SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory POVIDONE-IODINE .1 mL/mL N 20181231 42947-620_cfb71f6b-f8bd-43bb-a047-329778763926 42947-620 HUMAN OTC DRUG First Aid Antiseptic Benzalkonium Chloride SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory BENZALKONIUM CHLORIDE .0013 mL/mL N 20181231 42947-621_1a90d4a5-023d-4627-b3ce-6aa0370786bc 42947-621 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SWAB TOPICAL 20080101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory POVIDONE-IODINE .1 mL/mL N 20181231 42947-630_4e328079-e975-4e4e-84c3-48d8a713c127 42947-630 HUMAN OTC DRUG Obstetrical Antiseptic Benzalkonium Chloride SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory BENZALKONIUM CHLORIDE .0013 mL/mL N 20181231 42947-631_f3897610-a91c-49a7-901c-40a2896f9509 42947-631 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SWAB TOPICAL 20080101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory POVIDONE-IODINE .1 mL/mL N 20181231 42947-650_28502050-0f73-4cb1-9aaa-f682ee606ee6 42947-650 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory ISOPROPYL ALCOHOL .7 mL/mL N 20181231 42947-650_589d1413-6e38-4174-be9e-7961647e0ae9 42947-650 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory ISOPROPYL ALCOHOL .7 mL/mL N 20181231 42947-650_724b0f69-079a-4e42-bbee-85da828c5905 42947-650 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory ISOPROPYL ALCOHOL .7 mL/mL N 20181231 42947-650_adb315dd-9271-4fbe-baa3-6c6148cebadf 42947-650 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Wuxi Medical Instrument Factory ISOPROPYL ALCOHOL .7 mL/mL N 20181231 42952-101_613d8dc2-aebb-4d6b-8e7b-dd0071db0af3 42952-101 HUMAN OTC DRUG I-MAX EXCELLENCE AVOBENZONE OCTINOXATE OXYBENZONE LOTION TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part352 MAXLIFE USA, INC. AVOBENZONE; OCTINOXATE; OXYBENZONE 2.5; 7.5; 5 g/100mL; g/100mL; g/100mL E 20171231 42952-201_db996b27-1fdf-4e56-93d2-6a0d3b6a79fe 42952-201 HUMAN OTC DRUG I-MAX LIGHTENING 5 HYDROQUINONE CREAM TOPICAL 20120918 OTC MONOGRAPH NOT FINAL part358A MAXLIFE USA, INC. HYDROQUINONE 2 g/100g E 20171231 42952-203_b711e38c-61b2-484d-bfac-880abcf04e38 42952-203 HUMAN OTC DRUG I-MAX LIGHTENING L HYDROQUINONE CREAM TOPICAL 20120918 OTC MONOGRAPH NOT FINAL part358A MAXLIFE USA, INC. HYDROQUINONE 2 g/100g E 20171231 42953-000_f7649670-7f8f-4d88-9ee6-6bd5b935996f 42953-000 HUMAN OTC DRUG DEFENDER Antiseptic Foam Hand BENZALKONIUM CHLORIDE SOAP TOPICAL 20121011 OTC MONOGRAPH FINAL part333E Scientific Molecular Technologies BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 42953-001_5e664169-6563-4036-b8f8-405785d15f73 42953-001 HUMAN OTC DRUG DEFENDER Foaming Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121011 OTC MONOGRAPH FINAL part333E Scientific Molecular Technologies ALCOHOL 62 mL/100mL N 20181231 42953-002_d2c15533-4c20-4229-a9e9-ab295e77753a 42953-002 HUMAN OTC DRUG DEFENDER Antiseptic Foam Hand Sanitizer Alcohol-Free BENZALKONIUM CHLORIDE LIQUID TOPICAL 20121011 OTC MONOGRAPH FINAL part333E Scientific Molecular Technologies BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 42957-001_a383bfe6-3a12-4fe6-aa0a-34c9c2cde13e 42957-001 HUMAN OTC DRUG BabySpa Shea Butter Diaper Zinc Oxide CREAM TOPICAL 20120718 UNAPPROVED DRUG OTHER EXPRO3 LLC ZINC OXIDE 120 mg/mL E 20171231 42957-002_98405d64-9dc9-4dfd-9045-3bcdfacd360b 42957-002 HUMAN OTC DRUG BabySpa Calming Relief Eczema Colloidal Oatmeal CREAM TOPICAL 20130325 OTC MONOGRAPH FINAL part347 Expro3, LLC OATMEAL 1.25 g/125g E 20171231 42961-001_5d18e94b-73a5-4e5a-b728-8d1ae8b8094c 42961-001 HUMAN OTC DRUG Antibacterial Foaming Hand Benzalkonium Chloride LIQUID TOPICAL 20080422 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. BENZALKONIUM CHLORIDE 1.25 mg/mL N 20181231 42961-002_ccc07401-5294-4f45-8a35-5850ae2471e8 42961-002 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20080422 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. ALCOHOL 62 mL/100mL N 20181231 42961-005_c258e660-4b7b-4e43-9deb-cfacf3b51fa4 42961-005 HUMAN OTC DRUG Alcohol Foaming Hand Sanitizer Alcohol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. ALCOHOL 62 mL/100mL N 20181231 42961-007_c574b8d5-6983-4aaf-bfda-7438af10da28 42961-007 HUMAN OTC DRUG Antibacterial Triclosan SOAP TOPICAL 20100224 OTC MONOGRAPH NOT FINAL part333A Cintas Corp TRICLOSAN 5 mg/mL N 20181231 42961-008_cab7ca77-b98a-4c65-924c-056621f000fc 42961-008 HUMAN OTC DRUG Antibacterial Handsoap Chloroxylenol GEL TOPICAL 20100503 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. CHLOROXYLENOL 10 mg/mL N 20181231 42961-009_e3da00e6-079e-4710-a9e5-6ee789f5f57f 42961-009 HUMAN OTC DRUG Foaming Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part333A Cintas Corp BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 42961-011_588bb9f8-e8fa-437b-b29e-d817d6140be0 42961-011 HUMAN OTC DRUG Signature Antibacterial Foaming Hand BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140710 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. BENZALKONIUM CHLORIDE 1.2 mg/mL N 20181231 42961-012_1262ec0f-de4f-431a-9845-827bc669d45a 42961-012 HUMAN OTC DRUG Alcohol Foaming Hand Sanitizer ALCOHOL LIQUID TOPICAL 20140711 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. ALCOHOL 62 mL/100mL N 20181231 42961-013_f1334f57-6e08-4da9-aae8-82113afb87a8 42961-013 HUMAN OTC DRUG Signature Alcohol Foaming Hand Sanitizer ALCOHOL LIQUID TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. ALCOHOL 62 mL/100mL N 20181231 42961-090_d38a90ce-4733-4abb-a2ac-8176273a6515 42961-090 HUMAN OTC DRUG fad first aid direct Eyewash purified water SOLUTION CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140715 OTC MONOGRAPH FINAL part349 Cintas Corporation WATER 985.77 g/1000mL E 20171231 42961-091_d38a90ce-4733-4abb-a2ac-8176273a6515 42961-091 HUMAN OTC DRUG Xpect First aid Buffered Eyewash purified water SOLUTION CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140715 OTC MONOGRAPH FINAL part349 Cintas Corporation WATER 985.77 g/1000mL E 20171231 42961-092_d38a90ce-4733-4abb-a2ac-8176273a6515 42961-092 HUMAN OTC DRUG Eyewash Flushing Solution purified water SOLUTION CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140715 OTC MONOGRAPH FINAL part349 Cintas Corporation WATER 985.77 g/1000mL E 20171231 42961-093_d38a90ce-4733-4abb-a2ac-8176273a6515 42961-093 HUMAN OTC DRUG Xpect First aid Buffered Eye and Skin purified water SOLUTION CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140715 OTC MONOGRAPH FINAL part349 Cintas Corporation WATER 985.77 g/1000mL E 20171231 42961-094_d38a90ce-4733-4abb-a2ac-8176273a6515 42961-094 HUMAN OTC DRUG fad first aid direct Buffered Eye and Skin purified water SOLUTION CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140715 OTC MONOGRAPH FINAL part349 Cintas Corporation WATER 985.77 g/1000mL E 20171231 42961-124_0bddba0a-eade-47da-8373-fcb10d723b62 42961-124 HUMAN OTC DRUG Antacid Fruit Flavor Antacid TABLET ORAL 20140619 OTC MONOGRAPH FINAL part331 Cintas CALCIUM CARBONATE 500 mg/1 E 20171231 42961-159_535a0f0c-0ceb-47cb-99b3-77c90a55a859 42961-159 HUMAN OTC DRUG theSafetyDirector aquapreserv purified water SOLUTION, CONCENTRATE CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140715 OTC MONOGRAPH FINAL part349 Cintas Corporation WATER 992.96 g/1000mL E 20171231 42961-235_0272690e-0a82-41b7-a27a-3b5b860c55bc 42961-235 HUMAN OTC DRUG Acetaminophen Maximum Strength Acetaminophen TABLET ORAL 20141120 OTC MONOGRAPH NOT FINAL part343 CINTAS ACETAMINOPHEN 500 mg/1 E 20171231 42961-300_934f43bb-4712-4ac4-87ee-d3969c4b63c1 42961-300 HUMAN OTC DRUG First Aid Direct Buffered Eyewash Sterile Isotonic Water SOLUTION OPHTHALMIC 20111001 OTC MONOGRAPH FINAL part349 Cintas WATER .98 mL/mL E 20171231 42961-301_c9f59698-8a6c-47e1-b5a8-b543f2ece863 42961-301 HUMAN OTC DRUG Xpect Buffered Eyewash Sterile Isotonic Water SOLUTION OPHTHALMIC 20111001 OTC MONOGRAPH FINAL part349 Cintas WATER .98 mL/mL E 20171231 42961-333_e8c1106b-d5b3-492e-903c-40215fbd5d07 42961-333 HUMAN OTC DRUG Sine-EEz Sinus Decongestant TABLET ORAL 20161129 OTC MONOGRAPH FINAL part341 Cintas PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 N 20181231 42961-401_49b25e9e-1d48-4a10-e054-00144ff8d46c 42961-401 HUMAN OTC DRUG cherry throat relief lozenges benzocaine LOZENGE ORAL 20150227 OTC MONOGRAPH NOT FINAL part356 Cintas Corporation MENTHOL; BENZOCAINE 3.6; 15 mg/1; mg/1 N 20181231 42961-500_fd3d2786-032d-4549-8cd5-43c6e0330fb6 42961-500 HUMAN OTC DRUG ANTISEPTIC TOWELETTE BENZALKONIUM CHLORIDE SWAB TOPICAL 20131219 OTC MONOGRAPH NOT FINAL part333A Cintas Corp. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 42961-504_35fe8dc4-5973-4b82-b83a-35d2c99c9fa6 42961-504 HUMAN OTC DRUG ALCOHOL WIPE ISOPROPYL ALCOHOL SWAB TOPICAL 20140225 OTC MONOGRAPH FINAL part344 Cintas Corporation ISOPROPYL ALCOHOL .7 g/mL E 20171231 42976-121_ed3eaf69-1cbd-4b01-a6fa-1fe02c90c3e1 42976-121 HUMAN PRESCRIPTION DRUG ATryn Antithrombin (Recombinant) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090506 BLA BLA125284 GTC Biotherapeutics, Inc. ANTITHROMBIN ALFA 1750 [iU]/1 Recombinant Antithrombin [EPC],Decreased Coagulation Factor Activity [PE],Thrombin Inhibitors [MoA],Factor Xa Inhibitors [MoA] E 20171231 42976-125_2c5e8a5c-7985-4cb8-9dbc-3bf646f9fe46 42976-125 HUMAN PRESCRIPTION DRUG ATryn Antithrombin Recombinant INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090506 BLA BLA125284 rEVO Bioloigics, Inc. ANTITHROMBIN ALFA 525 [iU]/mL Recombinant Antithrombin [EPC],Decreased Coagulation Factor Activity [PE],Thrombin Inhibitors [MoA],Factor Xa Inhibitors [MoA] E 20171231 42979-100_083dc305-9c3c-4ccb-bd54-81cf4b3e3be6 42979-100 HUMAN OTC DRUG HES CLEAN ALCOHOL GEL TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333E DOCTOR C&C CO., LTD. ALCOHOL 6 mL/200mL E 20171231 42979-110_d4f4bcf1-b714-43bd-9767-d0963f23ffd4 42979-110 HUMAN OTC DRUG HES CLEAN PLUS ALCOHOL GEL TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333E DOCTOR C&C CO., LTD. ALCOHOL 4 mg/50mL E 20171231 42979-120_06874f7f-f609-4afd-91aa-ddb96f70ecff 42979-120 HUMAN OTC DRUG HES CLEAN ADAM Alcohol GEL TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part333E DOCTOR C&C ALCOHOL 5.4 mg/180mL E 20171231 42979-130_fcd7b31b-9d3a-4325-a44e-f5ad66657019 42979-130 HUMAN OTC DRUG HES CLEAN EVE Alcohol GEL TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part333E DOCTOR C&C ALCOHOL 1.8 mg/180mL E 20171231 42979-140_a56416f5-5645-40ba-b437-9c4c90760706 42979-140 HUMAN OTC DRUG HES CLEAN FOR WOMAN Alcohol SOLUTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part333E DOCTOR C&C ALCOHOL 1.8 mg/180mL E 20171231 42979-150_0c1ba3f0-67a6-42cc-b92f-f5142fa9ce17 42979-150 HUMAN OTC DRUG HEISCLEAN FOR MAN Alcohol GEL TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part333E HEISCLEAN.CO.,LTD ALCOHOL 6 g/200g N 20181231 42979-160_4dd0d088-bd32-4903-9e0c-d528a28f3cb3 42979-160 HUMAN OTC DRUG HEISCLEAN FOR WOMAN Alcohol GEL TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part333E HEISCLEAN.CO.,LTD ALCOHOL 2 g/200g N 20181231 42982-4441_c250f55d-211a-450b-ae6d-59cbc9854848 42982-4441 HUMAN OTC DRUG Bekunis Natures Gentle Stimulant Laxative SENNOSIDES A AND B TABLET, SUGAR COATED ORAL 20110210 OTC MONOGRAPH NOT FINAL part334 roha arzneimittel GmbH SENNOSIDES A AND B 20 mg/1 E 20171231 42982-4451_e4967721-b5b0-43b4-8c42-a58b45b6ce4a 42982-4451 HUMAN OTC DRUG Bekunis Natures Gentle Laxative Instant Tea SENNOSIDES POWDER ORAL 20110321 OTC MONOGRAPH NOT FINAL part334 roha arzneimittel GmbH SENNOSIDES A AND B 20 mg/.5g E 20171231 42982-4461_ccf5985f-7661-4602-99f3-2b623332f440 42982-4461 HUMAN OTC DRUG Bekunis Natures Gentle Laxative Herbal Tea SENNOSIDES EXTRACT ORAL 20110321 OTC MONOGRAPH NOT FINAL part334 roha arzneimittel GmbH SENNOSIDES A AND B 23 mg/g E 20171231 42998-501_c1a7bf24-91d5-4377-b4e8-a7db70a871dc 42998-501 HUMAN PRESCRIPTION DRUG EMFLAZA deflazacort TABLET ORAL 20170209 NDA NDA208684 Marathon Pharmaceuticals, LLC DEFLAZACORT 6 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 42998-502_c1a7bf24-91d5-4377-b4e8-a7db70a871dc 42998-502 HUMAN PRESCRIPTION DRUG EMFLAZA deflazacort TABLET ORAL 20170209 NDA NDA208684 Marathon Pharmaceuticals, LLC DEFLAZACORT 18 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 42998-503_c1a7bf24-91d5-4377-b4e8-a7db70a871dc 42998-503 HUMAN PRESCRIPTION DRUG EMFLAZA deflazacort TABLET ORAL 20170209 NDA NDA208684 Marathon Pharmaceuticals, LLC DEFLAZACORT 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 42998-504_c1a7bf24-91d5-4377-b4e8-a7db70a871dc 42998-504 HUMAN PRESCRIPTION DRUG EMFLAZA deflazacort TABLET ORAL 20170209 NDA NDA208684 Marathon Pharmaceuticals, LLC DEFLAZACORT 36 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 42998-505_c1a7bf24-91d5-4377-b4e8-a7db70a871dc 42998-505 HUMAN PRESCRIPTION DRUG EMFLAZA deflazacort SUSPENSION ORAL 20170209 NDA NDA208685 Marathon Pharmaceuticals, LLC DEFLAZACORT 22.75 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 42998-974_c6b07acd-204f-4a34-92de-2217e93a9875 42998-974 HUMAN PRESCRIPTION DRUG Pepcid Famotidine TABLET, FILM COATED ORAL 20140527 20190131 ANDA ANDA075805 Marathon Pharmaceuticals FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 43063-008_5d672d19-9fe9-7965-e053-2a91aa0a984b 43063-008 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-010_5b23a410-18be-b8d7-e053-2a91aa0ae330 43063-010 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 20180926 ANDA ANDA040412 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43063-012_5e20d274-d04d-400c-e053-2991aa0a1b69 43063-012 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43063-013_49123659-53e6-0fb5-e054-00144ff8d46c 43063-013 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-014_5c3d3c7f-70d2-988c-e053-2991aa0a1bf3 43063-014 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 PD-Rx Pharmaceuticals, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 43063-015_4fcf60de-cc77-2549-e054-00144ff88e88 43063-015 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070301 ANDA ANDA065291 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-016_4fbeb025-6e43-1f52-e054-00144ff88e88 43063-016 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-017_4fcecd86-c384-6160-e054-00144ff88e88 43063-017 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070301 ANDA ANDA065291 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-018_5e211538-658f-ec63-e053-2a91aa0aff51 43063-018 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071135 PD-Rx Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-019_625f253d-c6d8-913e-e053-2a91aa0a3758 43063-019 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20191231 43063-020_5b4a43b8-800c-7ae2-e053-2991aa0afd9c 43063-020 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 PD-Rx Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 43063-021_437f1a69-02cd-4c30-9e3d-954fe9942a4e 43063-021 VACCINE Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070033 PD-Rx Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 43063-024_6361e5d8-267e-b2df-e053-2a91aa0a94c8 43063-024 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 PD-Rx Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 43063-025_5bae3108-2278-3b11-e053-2991aa0acd9e 43063-025 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-028_5b215228-1351-176b-e053-2991aa0a4460 43063-028 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 PD-Rx Pharmaceuticals, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 43063-030_579653e1-be6d-e0a5-e053-2a91aa0a2a2e 43063-030 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 19870717 ANDA ANDA071858 PD-Rx Pharmaceuticals, Inc. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-033_5bab8460-63f9-95a9-e053-2991aa0a882a 43063-033 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-034_649c183e-9b7c-4e94-90c1-d34eab2860dd 43063-034 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 PD-Rx Pharmaceuticals, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43063-036_5b376952-0120-adfc-e053-2a91aa0ae464 43063-036 HUMAN PRESCRIPTION DRUG Ketoconazole ketoconazole TABLET ORAL 20000223 ANDA ANDA075597 PD-Rx Pharmaceuticals, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 43063-038_5c7468bf-b4b7-533e-e053-2a91aa0a0c3c 43063-038 HUMAN PRESCRIPTION DRUG Comfort Pac with Ibuprofen Ibuprofen KIT 20120906 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. N 20181231 43063-041_5bc395e4-eaab-f949-e053-2a91aa0a449c 43063-041 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20101020 ANDA ANDA078925 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43063-045_5c8c3bee-ce20-a776-e053-2a91aa0a2d40 43063-045 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 PD-Rx Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 43063-046_5d7f1c70-b23f-7d4e-e053-2a91aa0a7bba 43063-046 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760701 ANDA ANDA084769 PD-Rx Pharmaceuticals, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-047_4fbf742e-22a3-09ca-e054-00144ff8d46c 43063-047 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-048_58769ba8-1fb8-1453-e053-2991aa0ac04d 43063-048 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 PD-Rx Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-050_597db328-6739-f2ec-e053-2991aa0a2436 43063-050 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20100218 ANDA ANDA078218 PD-Rx Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43063-051_5b33f48d-9c2f-4990-e053-2991aa0ab72f 43063-051 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA077471 PD-Rx Pharmaceuticals, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-052_6287b20b-5b63-fb78-e053-2a91aa0a0526 43063-052 HUMAN PRESCRIPTION DRUG ondansetron ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 PD-Rx Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 43063-053_593f997d-f3cd-24ec-e053-2991aa0a4716 43063-053 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 43063-054_5e3166dc-191a-0c7e-e053-2991aa0a5b66 43063-054 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 20200531 ANDA ANDA062936 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-055_63ecbc23-cc9c-63d6-e053-2991aa0ad7af 43063-055 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 PD-Rx Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20191231 43063-056_629b4c3c-9bc1-2e80-e053-2991aa0aaaac 43063-056 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19900101 ANDA ANDA063083 PD-Rx Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 43063-057_5b4b9267-3204-1f82-e053-2991aa0a2fc5 43063-057 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072926 PD-Rx Pharmaceuticals, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-059_5bd61cd4-a5cd-9d66-e053-2a91aa0a93a3 43063-059 HUMAN PRESCRIPTION DRUG TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET ORAL 20010626 ANDA ANDA075877 PD-Rx Pharmaceuticals, Inc. TERBUTALINE SULFATE 5 mg/1 N 20181231 43063-060_5bc235d3-c33a-2710-e053-2991aa0a73cb 43063-060 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20060517 ANDA ANDA040500 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 43063-061_5812838a-3f60-4b66-e053-2991aa0a3b8c 43063-061 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120723 ANDA ANDA074215 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-063_593fce25-9960-6a95-e053-2991aa0a678b 43063-063 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100406 ANDA ANDA077289 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-064_5b60268e-7078-39b5-e053-2a91aa0ae9de 43063-064 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 PD-Rx Pharmaceuticals, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43063-065_50229eb3-8a2f-221a-e054-00144ff88e88 43063-065 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-068_5bfc0d11-1916-684a-e053-2991aa0a149b 43063-068 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076578 PD-Rx Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 43063-074_5d7c29d3-4fa1-f202-e053-2a91aa0a8781 43063-074 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-075_5c505f92-0e9f-72b5-e053-2a91aa0a297c 43063-075 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 PD-Rx Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43063-077_628333b4-14a4-de1c-e053-2a91aa0a8aa2 43063-077 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 43063-079_629b77cf-f829-8640-e053-2991aa0a10a8 43063-079 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 PD-Rx Pharmaceuticals, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20191231 43063-080_2b47ab1b-92c3-2677-e054-00144ff88e88 43063-080 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-086_5b215228-130e-176b-e053-2991aa0a4460 43063-086 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075511 PD-Rx Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 43063-087_5d7d39b0-0169-52e7-e053-2a91aa0a375b 43063-087 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 PD-Rx Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 43063-088_5812d5cd-cbfe-1e32-e053-2a91aa0a967c 43063-088 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120723 ANDA ANDA074215 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-089_59a5c21b-5345-515c-e053-2991aa0aecde 43063-089 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 PD-Rx Pharmaceuticals, Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 43063-090_835e8839-80f4-45aa-9989-9fa173195d9f 43063-090 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 43063-091_5e317b44-1666-382f-e053-2a91aa0a2e9d 43063-091 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 PD-Rx Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 43063-092_5b728a8d-0386-d300-e053-2a91aa0a6b6a 43063-092 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040114 ANDA ANDA076494 PD-Rx Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-094_5e306bb1-09dc-4f71-833f-211ccddb0fe3 43063-094 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-095_504bcee0-1c14-3f9b-e054-00144ff8d46c 43063-095 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 43063-096_5bb02e8f-22d3-4fc3-e053-2a91aa0aff38 43063-096 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 20201231 ANDA ANDA062935 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-097_5e212948-6888-bdf2-e053-2991aa0a649f 43063-097 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 PD-Rx Pharmaceuticals, Inc. PREDNISONE 20 mg/1 N 20181231 43063-108_5b6087ac-367e-7d10-e053-2a91aa0a8f23 43063-108 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 PD-Rx Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 43063-111_58efe15f-d7f5-2d1b-e053-2a91aa0a82dd 43063-111 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 PD-Rx Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 43063-112_59a31f3a-aaac-b565-e053-2991aa0ace98 43063-112 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 PD-Rx Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 43063-113_49ce60ed-d2e5-44a5-b52d-7fc8467ba8aa 43063-113 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 43063-114_504c4ea9-8de0-6545-e054-00144ff88e88 43063-114 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-118_559db667-45d9-6ed0-e054-00144ff8d46c 43063-118 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-119_62d7b3c5-cfb1-08d3-e053-2a91aa0abb8f 43063-119 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19990917 ANDA ANDA074792 PD-Rx Pharmaceuticals, Inc. GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 43063-120_62d7e2d4-a154-5faf-e053-2a91aa0a8e58 43063-120 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19990917 ANDA ANDA074792 PD-Rx Pharmaceuticals, Inc. GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 43063-121_4fbb3166-c5fc-6936-e054-00144ff88e88 43063-121 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 PD-Rx Pharmaceuticals, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43063-122_4fbb2893-1e49-1f79-e054-00144ff88e88 43063-122 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 PD-Rx Pharmaceuticals, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43063-125_63ed4655-2ce5-b791-e053-2a91aa0af937 43063-125 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 PD-Rx Pharmaceuticals, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 43063-126_62e97be1-71d0-e056-e053-2a91aa0a25a6 43063-126 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 PD-Rx Pharmaceuticals, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 43063-129_62ea730e-d811-1fac-e053-2991aa0ad740 43063-129 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 PD-Rx Pharmaceuticals, Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 43063-130_559db667-461c-6ed0-e054-00144ff8d46c 43063-130 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA075776 PD-Rx Pharmaceuticals, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43063-131_5c4c3c72-efbe-ebe0-e053-2a91aa0a224e 43063-131 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43063-132_62eb0500-cebc-fe10-e053-2a91aa0af5c3 43063-132 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 43063-133_4f946656-81b7-317f-e054-00144ff8d46c 43063-133 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20000501 ANDA ANDA075366 PD-Rx Pharmaceuticals, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 43063-134_62eced25-e790-030a-e053-2a91aa0a8d37 43063-134 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20000925 ANDA ANDA075768 PD-Rx Pharmaceuticals, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 43063-138_5023aab4-77c7-4380-e054-00144ff88e88 43063-138 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-139_608d08b0-6a4e-412a-b82f-4341fac5f473 43063-139 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN and CODEINE ACETAMINOPHEN and CODEINE SOLUTION ORAL 20100101 ANDA ANDA040746 PD-Rx Pharmaceuticals, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 12; 120 mg/5mL; mg/5mL CV N 20181231 43063-142_62fe7c81-fcbb-155d-e053-2991aa0af2eb 43063-142 HUMAN PRESCRIPTION DRUG Pentazocine and naloxone Pentazocine hydrochloride and naloxone hydrochloride TABLET ORAL 19970521 ANDA ANDA074736 PD-Rx Pharmaceuticals, Inc. PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 50; .5 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV N 20191231 43063-143_559e1c57-6900-6ea4-e054-00144ff8d46c 43063-143 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20091231 ANDA ANDA076714 PD-Rx Pharmaceuticals, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-145_5bacd44b-36c7-4818-e053-2a91aa0a45fc 43063-145 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 PD-Rx Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 43063-146_62ff1da3-7948-676a-e053-2991aa0a4a9f 43063-146 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 19960213 ANDA ANDA074434 PD-Rx Pharmaceuticals, Inc. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 43063-160_5d7cb4bd-9a60-4809-abcb-7e7b5a9cce0f 43063-160 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20101213 ANDA ANDA040185 PD-Rx Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 43063-162_276fa728-279c-4272-e054-00144ff8d46c 43063-162 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-164_5c50858a-5f9e-266c-e053-2991aa0af181 43063-164 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 20100729 ANDA ANDA071858 PD-Rx Pharmaceuticals, Inc. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-170_5baf27f5-428f-1583-e053-2991aa0a8e34 43063-170 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20130204 ANDA ANDA078902 PD-Rx Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-172_b12ca138-2dfa-461a-8ea2-f10a00941f89 43063-172 HUMAN PRESCRIPTION DRUG hydoxyzine pamoate hydoxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA087479 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 43063-173_5b735b2c-bfc0-af9a-e053-2991aa0a228d 43063-173 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals nitrofurantoin (macrocrystals) CAPSULE ORAL 20040921 ANDA ANDA077025 PD-Rx Pharmaceuticals, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 43063-174_5b37ad88-ffbb-4d29-e053-2991aa0aed65 43063-174 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20130516 ANDA ANDA074761 PD-Rx Pharmaceuticals, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 43063-176_62fffc99-75df-4360-e053-2a91aa0a5e75 43063-176 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150407 ANDA ANDA040616 PD-Rx Pharmaceuticals, Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 43063-177_63004034-1202-c9c8-e053-2991aa0a359a 43063-177 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 43063-178_63751e77-518f-37f0-e053-2991aa0a30e3 43063-178 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 43063-180_5bfd6377-a642-2e04-e053-2991aa0a9ceb 43063-180 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 PD-Rx Pharmaceuticals, Inc. DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-182_5d15a570-b878-a8a9-e053-2991aa0ae06f 43063-182 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120815 ANDA ANDA040887 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 43063-188_50ff430c-16e2-2b8e-e054-00144ff88e88 43063-188 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, EXTENDED RELEASE ORAL 20101115 ANDA ANDA075028 PD-Rx Pharmaceuticals, Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 43063-189_b26bf0f6-aadb-4b50-b2fb-56c52d50d06f 43063-189 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-190_5f37ddd7-8632-16fc-e053-2a91aa0a5fca 43063-190 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090903 ANDA ANDA070317 PD-Rx Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 43063-191_5bfd6c82-7c85-566a-e053-2a91aa0aa7c5 43063-191 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 43063-193_63754cf1-2cbf-801a-e053-2991aa0a3e01 43063-193 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 PD-Rx Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20191231 43063-194_4fbef499-dd5d-2a00-e054-00144ff88e88 43063-194 HUMAN PRESCRIPTION DRUG CEFACLOR CEFACLOR CAPSULE ORAL 20070501 ANDA ANDA065350 PD-Rx Pharmaceuticals, Inc. CEFACLOR 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-195_559e14c5-687a-15ba-e054-00144ff88e88 43063-195 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20091231 ANDA ANDA076714 PD-Rx Pharmaceuticals, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-196_52e26c96-c810-0f1c-e054-00144ff8d46c 43063-196 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20030301 ANDA ANDA076243 PD-Rx Pharmaceuticals, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 43063-197_63eec31d-74cd-4b5a-e053-2991aa0a76f2 43063-197 HUMAN PRESCRIPTION DRUG FLUOXETINE fluoxetine hydrochloride CAPSULE ORAL 20081014 ANDA ANDA076922 PD-Rx Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 43063-200_4fbea9e7-6088-1e82-e054-00144ff88e88 43063-200 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20070131 ANDA ANDA076588 PD-Rx Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 43063-202_50600e29-7556-5c3c-e054-00144ff88e88 43063-202 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 PD-Rx Pharmaceuticals, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43063-203_50605bca-4f07-66c5-e054-00144ff88e88 43063-203 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 PD-Rx Pharmaceuticals, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43063-208_5e081b3d-642d-0bcf-e053-2a91aa0ac7e0 43063-208 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20070716 ANDA ANDA040761 PD-Rx Pharmaceuticals, Inc. HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43063-209_5438dd04-9d46-0e45-e054-00144ff8d46c 43063-209 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20100118 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 43063-212_5b71b806-209e-a261-e053-2a91aa0a0fdf 43063-212 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 PD-Rx Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-213_4fb8dafc-4603-40e6-8c5d-37cea682d688 43063-213 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-214_1072dff9-daee-4dcc-930f-be3c6e386227 43063-214 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-216_f76f7c24-0a6f-4ade-99ec-26f531422300 43063-216 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20010802 ANDA ANDA075049 PD-Rx Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-217_d8dc77f4-d42f-4a5c-a4f7-cb001e6e3560 43063-217 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20100101 ANDA ANDA070791 PD-Rx Pharmaceuticals, Inc. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 43063-218_6377232f-4213-54a5-e053-2991aa0a3f0f 43063-218 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 20180228 ANDA ANDA040145 PD-Rx Pharmaceuticals, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 43063-219_5bae34b5-9343-f5ce-e053-2991aa0aef3a 43063-219 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20100101 ANDA ANDA077712 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-220_5e2148df-b4ad-eed4-e053-2991aa0a1cac 43063-220 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20070131 ANDA ANDA077712 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-221_6378a0dd-dfec-918b-e053-2991aa0a047d 43063-221 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20150529 ANDA ANDA077032 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 43063-222_5796a492-88a1-9a53-e053-2a91aa0a8e96 43063-222 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 PD-Rx Pharmaceuticals, Inc. METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-223_5269f5fd-a348-3653-e054-00144ff88e88 43063-223 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43063-225_5bc019b5-79e8-122b-e053-2991aa0a4ccc 43063-225 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET, FILM COATED ORAL 20110415 NDA NDA008316 PD-Rx Pharmaceuticals, Inc. PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] N 20181231 43063-228_469fcc0f-5813-4fcc-87ae-773130d936a2 43063-228 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20100101 ANDA ANDA080693 PD-Rx Pharmaceuticals, Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43063-230_518936b7-d3ef-628c-e054-00144ff8d46c 43063-230 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20100118 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 43063-233_9ec75fd5-2afd-41a8-b508-8f74ee20f8b1 43063-233 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43063-235_52e27904-cf70-010b-e054-00144ff8d46c 43063-235 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20100118 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 43063-236_ac34f5f8-ca50-47d9-bb9a-f8b28df86ae7 43063-236 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 PD-Rx Pharmaceuticals, Inc. TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 43063-237_5c75f4a4-8ba2-fb6e-e053-2a91aa0a74e0 43063-237 HUMAN PRESCRIPTION DRUG Comfort Pac with Tizanidine Tizanidine KIT 20130709 ANDA ANDA076280 PD-Rx Pharmaceuticals, Inc. N 20181231 43063-238_5798bd69-1346-f94e-e053-2991aa0a6a0e 43063-238 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 PD-Rx Pharmaceuticals, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43063-239_61cf854d-61c1-2bb4-e053-2991aa0a6d6d 43063-239 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 PD-Rx Pharmaceuticals, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20191231 43063-243_6379705d-4f51-35ae-e053-2991aa0a2a54 43063-243 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090324 ANDA ANDA079095 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 43063-248_5150c087-080b-4191-e054-00144ff88e88 43063-248 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20100210 ANDA ANDA072575 PD-Rx Pharmaceuticals, Inc. PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43063-249_6378d967-d431-2c65-e053-2991aa0a78da 43063-249 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20150529 ANDA ANDA077032 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 43063-250_5189534d-79d5-6daa-e054-00144ff8d46c 43063-250 HUMAN PRESCRIPTION DRUG clomiphene citrate clomiphene citrate TABLET ORAL 19670201 NDA NDA016131 PD-Rx Pharmaceuticals, Inc. CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 43063-251_5269f5fd-a322-3653-e054-00144ff88e88 43063-251 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20110901 ANDA ANDA088488 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 100 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 43063-252_518dfa79-2401-2bce-e054-00144ff88e88 43063-252 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 PD-Rx Pharmaceuticals, Inc. LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 43063-253_5189534d-7a04-6daa-e054-00144ff8d46c 43063-253 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 PD-Rx Pharmaceuticals, Inc. LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 43063-254_5bc445f3-6fc2-757f-e053-2991aa0a7701 43063-254 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 PD-Rx Pharmaceuticals, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 43063-255_527a517c-54cb-15fa-e054-00144ff8d46c 43063-255 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076219 PD-Rx Pharmaceuticals, Inc. MIRTAZAPINE 30 mg/1 N 20181231 43063-256_63799aab-7490-26c8-e053-2a91aa0a995b 43063-256 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 PD-Rx Pharmaceuticals, Inc. SILDENAFIL CITRATE 25 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 43063-257_6388f2fa-39c4-4025-e053-2991aa0afc32 43063-257 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride clomipramine hydrochloride CAPSULE ORAL 19980511 ANDA ANDA074947 PD-Rx Pharmaceuticals, Inc. CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 43063-259_526bc55b-9493-397e-e054-00144ff8d46c 43063-259 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20090127 ANDA ANDA078947 PD-Rx Pharmaceuticals, Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43063-260_5150d75b-2f80-44a9-e054-00144ff88e88 43063-260 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20100210 ANDA ANDA072575 PD-Rx Pharmaceuticals, Inc. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43063-261_55b38178-86ab-3ede-e054-00144ff8d46c 43063-261 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 PD-Rx Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 43063-262_527a4a58-98f4-1af0-e054-00144ff8d46c 43063-262 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20080501 NDA NDA021992 PD-Rx Pharmaceuticals, Inc. DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 43063-264_5bd47074-2110-1bd2-e053-2991aa0a1c78 43063-264 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 PD-Rx Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43063-266_50478011-26e7-53c0-e054-00144ff8d46c 43063-266 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19820826 ANDA ANDA087916 PD-Rx Pharmaceuticals, Inc. DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43063-268_5c76017a-4593-e4d1-e053-2a91aa0a143e 43063-268 HUMAN PRESCRIPTION DRUG Comfort Pac with Meloxicam Meloxicam KIT 20130709 ANDA ANDA077923 PD-Rx Pharmaceuticals, Inc. N 20181231 43063-269_6389fab8-88de-13bb-e053-2a91aa0af261 43063-269 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 PD-Rx Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 43063-270_5b1e8943-2612-68cf-e053-2a91aa0a9613 43063-270 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100127 ANDA ANDA076152 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-271_638a9cc0-107a-aef5-e053-2991aa0a5da0 43063-271 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20041004 ANDA ANDA075694 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 43063-272_55f294f4-24f9-2ec0-e054-00144ff88e88 43063-272 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 PD-Rx Pharmaceuticals, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-273_5d055071-40bc-2a90-e053-2a91aa0aaf82 43063-273 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 PD-Rx Pharmaceuticals, Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 43063-274_55f294f4-254e-2ec0-e054-00144ff88e88 43063-274 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 PD-Rx Pharmaceuticals, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-275_55f25ca5-74ce-20a7-e054-00144ff88e88 43063-275 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 PD-Rx Pharmaceuticals, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-279_5bacd44b-36ee-4818-e053-2a91aa0a45fc 43063-279 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 19960730 ANDA ANDA040105 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-280_5cda4017-da43-1b99-e053-2a91aa0abc40 43063-280 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074769 PD-Rx Pharmaceuticals, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-284_6287cb34-884f-66d4-e053-2991aa0a840f 43063-284 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100125 ANDA ANDA075491 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 43063-288_5d7e9407-27e8-dcd7-e053-2a91aa0a0c81 43063-288 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43063-290_55b335a8-d00e-6bb6-e054-00144ff88e88 43063-290 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 PD-Rx Pharmaceuticals, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 43063-292_552a0de1-320e-53bd-e054-00144ff8d46c 43063-292 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride TABLET ORAL 20080616 ANDA ANDA078301 PD-Rx Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-295_562c8df6-82ed-23d1-e054-00144ff88e88 43063-295 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078445 PD-Rx Pharmaceuticals, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43063-302_5888877b-a734-4b3c-e053-2a91aa0aca93 43063-302 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 PD-Rx Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 43063-303_5b606634-92cb-b9ab-e053-2991aa0a3786 43063-303 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080609 ANDA ANDA077626 PD-Rx Pharmaceuticals, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-304_5c8aa572-4e12-52c1-e053-2991aa0a5a33 43063-304 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20090302 ANDA ANDA077712 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-307_638a4cfe-4277-4a97-e053-2991aa0acdc8 43063-307 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 PD-Rx Pharmaceuticals, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 43063-308_5b3733ad-8ef3-966f-e053-2991aa0a7970 43063-308 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-313_559f5ad0-5ecf-401d-e054-00144ff88e88 43063-313 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 PD-Rx Pharmaceuticals, Inc. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 43063-321_55b3b1e4-dc43-4767-e054-00144ff8d46c 43063-321 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL; SUBLINGUAL 20090921 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. HYOSCYAMINE SULFATE .125 mg/1 N 20181231 43063-326_55ca29f7-f3c8-1be2-e054-00144ff8d46c 43063-326 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 PD-Rx Pharmaceuticals, Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 43063-328_5bff3a92-1f1b-7ca0-e053-2991aa0aecad 43063-328 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 PD-Rx Pharmaceuticals, Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 43063-329_518c493e-f41b-1529-e054-00144ff8d46c 43063-329 HUMAN PRESCRIPTION DRUG methylergonovine maleate methylergonovine maleate TABLET ORAL 20110801 ANDA ANDA091577 PD-Rx Pharmaceuticals, Inc. METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 43063-332_5bb0b7c6-12be-0ad5-e053-2a91aa0a5006 43063-332 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 43063-336_638cadc3-033f-0728-e053-2991aa0a25f8 43063-336 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 PD-Rx Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20191231 43063-340_6361e5d8-260e-b2df-e053-2a91aa0a94c8 43063-340 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 PD-Rx Pharmaceuticals, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 43063-341_589f12ed-f6cd-c819-e053-2a91aa0acd82 43063-341 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 19930101 ANDA ANDA064013 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-342_5877736b-295a-56ce-e053-2991aa0a456e 43063-342 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20020418 ANDA ANDA065065 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43063-344_5b730482-0977-7429-e053-2a91aa0a4ec9 43063-344 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 PD-Rx Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-345_5ae4b9ed-81d9-5db0-e053-2991aa0ac1f3 43063-345 HUMAN PRESCRIPTION DRUG ARMOUR THYROID THYROID TABLET ORAL 20101019 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. THYROID, PORCINE 30 mg/1 N 20181231 43063-346_52a4248b-01a1-2938-e054-00144ff88e88 43063-346 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20111227 ANDA ANDA079081 PD-Rx Pharmaceuticals, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 43063-347_559f5ad0-5ef0-401d-e054-00144ff88e88 43063-347 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43063-348_638d4cc0-6539-0736-e053-2a91aa0a1a42 43063-348 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TABLET ORAL 20101227 ANDA ANDA201212 PD-Rx Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20191231 43063-349_5b1fd0ef-2eef-fd26-e053-2991aa0a3c38 43063-349 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED ORAL 20040401 ANDA ANDA076604 PD-Rx Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 43063-350_5c51032b-f378-f68d-e053-2a91aa0a7540 43063-350 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 20100729 ANDA ANDA071858 PD-Rx Pharmaceuticals, Inc. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-352_5b3733ad-8f04-966f-e053-2991aa0a7970 43063-352 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-353_5bc085b8-f06b-5a72-e053-2a91aa0a82a2 43063-353 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 19961118 ANDA ANDA040185 PD-Rx Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 43063-354_5c50688b-a098-610b-e053-2991aa0af894 43063-354 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-362_55ca2fa8-102c-27d4-e054-00144ff88e88 43063-362 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-364_5ae4b9ed-81aa-5db0-e053-2991aa0ac1f3 43063-364 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-367_63ed4e7b-7ec2-d749-e053-2a91aa0afc8f 43063-367 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 43063-368_638dac56-2299-251b-e053-2a91aa0a1e16 43063-368 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 PD-Rx Pharmaceuticals, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 43063-369_639e932c-52ed-d2b3-e053-2a91aa0a1ce9 43063-369 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 PD-Rx Pharmaceuticals, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20191231 43063-370_60f17b9f-555d-ae95-e053-2a91aa0a7060 43063-370 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-371_5c5191fd-f254-7b77-e053-2991aa0a4316 43063-371 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET ORAL 20120517 ANDA ANDA090844 PD-Rx Pharmaceuticals, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 43063-372_61f63653-b0ad-7490-e053-2991aa0a7df5 43063-372 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20050401 ANDA ANDA076869 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 43063-373_559f53b7-bd2c-3f76-e054-00144ff88e88 43063-373 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-374_5b1f8da0-bcc8-a031-e053-2991aa0a60e8 43063-374 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-376_648fe871-a708-deb4-e053-2a91aa0a0e25 43063-376 HUMAN PRESCRIPTION DRUG PHENADOZ Promethazine Hydrochloride SUPPOSITORY RECTAL 20150316 ANDA ANDA040428 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 43063-377_589edd23-c44a-de1d-e053-2991aa0a5e99 43063-377 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43063-380_639f6230-98b7-e7ea-e053-2991aa0a8f87 43063-380 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20120803 ANDA ANDA090655 PD-Rx Pharmaceuticals, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 43063-381_5d05230b-addd-0ddb-e053-2991aa0a62ca 43063-381 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA090984 PD-Rx Pharmaceuticals, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 43063-382_5c51c012-46a3-94cd-e053-2991aa0a2a8f 43063-382 HUMAN PRESCRIPTION DRUG Clorazepate dipotassium Clorazepate dipotassium TABLET ORAL 20050114 ANDA ANDA076911 PD-Rx Pharmaceuticals, Inc. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-383_5beab0d3-de6a-7443-e053-2a91aa0a7164 43063-383 HUMAN PRESCRIPTION DRUG ANASTROZOLE ANASTROZOLE TABLET ORAL 20100628 ANDA ANDA079220 PD-Rx Pharmaceuticals, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 43063-384_55f2f942-d909-1175-e054-00144ff8d46c 43063-384 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 43063-385_597bc4e7-3533-bd77-e053-2991aa0a7fd4 43063-385 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100406 ANDA ANDA077289 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-386_55b31f2f-1c72-5cbd-e054-00144ff88e88 43063-386 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 19730618 ANDA ANDA083365 PD-Rx Pharmaceuticals, Inc. HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43063-387_5e07050e-cfc6-55a3-e053-2a91aa0abd76 43063-387 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43063-388_552a0de1-32c6-53bd-e054-00144ff8d46c 43063-388 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43063-389_552ad082-747f-1b97-e054-00144ff8d46c 43063-389 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-390_552af2cd-3e99-0cb9-e054-00144ff88e88 43063-390 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-391_5f11aa0a-82f8-3af1-e053-2a91aa0a4d98 43063-391 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20100315 ANDA ANDA040865 PD-Rx Pharmaceuticals, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 43063-392_559f53b7-bd76-3f76-e054-00144ff88e88 43063-392 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 PD-Rx Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 43063-393_55ca29f7-f3eb-1be2-e054-00144ff8d46c 43063-393 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 PD-Rx Pharmaceuticals, Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 43063-394_5bab321f-b492-e326-e053-2991aa0a62d4 43063-394 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20050812 ANDA ANDA065242 PD-Rx Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 43063-395_5a9531d8-4b84-4574-e053-2a91aa0ad7cb 43063-395 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 PD-Rx Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-396_5b5dbde6-2fb7-c0ab-e053-2991aa0a4c88 43063-396 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 PD-Rx Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-397_5b234948-3d14-3656-e053-2a91aa0abe24 43063-397 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20050628 ANDA ANDA076716 PD-Rx Pharmaceuticals, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43063-400_59a13396-5bf7-c6d9-e053-2991aa0ae92f 43063-400 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 PD-Rx Pharmaceuticals, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 43063-401_552af2cd-3eed-0cb9-e054-00144ff88e88 43063-401 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 PD-Rx Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-402_63a0189b-1116-838e-e053-2991aa0a8dc2 43063-402 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20070518 ANDA ANDA077179 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 43063-403_559f984c-9011-3a48-e054-00144ff8d46c 43063-403 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43063-404_63a0b95c-2a36-0923-e053-2991aa0ae49f 43063-404 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100621 ANDA ANDA078477 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 43063-405_5bc4334b-deec-2a8d-e053-2a91aa0a5c44 43063-405 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 43063-406_5ae561b0-c05e-6df3-e053-2a91aa0ac0ef 43063-406 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20140627 ANDA ANDA087479 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 43063-407_5c51eb08-44f4-e326-e053-2991aa0aed6d 43063-407 HUMAN PRESCRIPTION DRUG ORPHENADRINE CITRATE ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 PD-Rx Pharmaceuticals, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43063-408_553c604c-abf6-5ae1-e054-00144ff8d46c 43063-408 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 PD-Rx Pharmaceuticals, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-409_63a0d984-d223-2c94-e053-2a91aa0a9872 43063-409 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 PD-Rx Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 43063-410_643dd323-cfab-a764-e053-2a91aa0a392a 43063-410 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 43063-411_5bd3519f-4c32-2b78-e053-2a91aa0a8626 43063-411 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-412_559fa71f-f9ad-55e8-e054-00144ff8d46c 43063-412 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20120127 ANDA ANDA091662 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43063-413_552b323f-cbbf-2f64-e054-00144ff8d46c 43063-413 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-416_5c5222cd-e427-40ef-e053-2991aa0ae7eb 43063-416 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 PD-Rx Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43063-417_552b5106-8cb9-199d-e054-00144ff88e88 43063-417 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-419_63a11550-3889-ac02-e053-2991aa0af56d 43063-419 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 PD-Rx Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 43063-420_5bc1c7a6-d382-47bb-e053-2a91aa0aa945 43063-420 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 43063-421_5c602bb8-33b1-7839-e053-2a91aa0aabf5 43063-421 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 43063-422_455eaccb-816b-1a90-e054-00144ff88e88 43063-422 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 43063-423_455ebb3e-0f78-0df8-e054-00144ff88e88 43063-423 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 43063-424_5150c087-082a-4191-e054-00144ff88e88 43063-424 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20110209 NDA NDA019129 PD-Rx Pharmaceuticals, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43063-425_55f0c132-6fd8-377b-e054-00144ff8d46c 43063-425 HUMAN PRESCRIPTION DRUG benzphetamine hydrochloride benzphetamine hydrochloride TABLET ORAL 20111101 ANDA ANDA090473 PD-Rx Pharmaceuticals, Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 43063-426_5c38affc-463e-9501-e053-2991aa0a6e1e 43063-426 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 PD-Rx Pharmaceuticals, Inc. PREDNISONE 10 mg/1 N 20181231 43063-427_63af2eb8-6923-907b-e053-2991aa0a7c08 43063-427 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 43063-428_6283724f-5a13-05b9-e053-2a91aa0ac135 43063-428 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 43063-429_55b3ce04-6193-0fc2-e054-00144ff88e88 43063-429 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin TABLET ORAL 20090601 ANDA ANDA077880 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43063-430_52e26c96-c828-0f1c-e054-00144ff8d46c 43063-430 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120427 ANDA ANDA077880 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43063-431_55b38178-870b-3ede-e054-00144ff8d46c 43063-431 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 19910918 ANDA ANDA072741 PD-Rx Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 43063-433_5f4ab945-cc95-2673-e053-2a91aa0af5b6 43063-433 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19940401 NDA AUTHORIZED GENERIC NDA017532 PD-Rx Pharmaceuticals, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43063-435_553eb5ab-54a4-4fd6-e054-00144ff8d46c 43063-435 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 43063-436_552b323f-cc25-2f64-e054-00144ff8d46c 43063-436 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-437_63afb761-d5e1-7fd1-e053-2991aa0a9430 43063-437 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20110308 ANDA ANDA200272 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20191231 43063-438_5b6ecb99-2646-6f04-e053-2a91aa0a5ea3 43063-438 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE TABLET ORAL 19590603 NDA AUTHORIZED GENERIC NDA011839 PD-Rx Pharmaceuticals, Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 43063-439_55391d77-2174-3f6b-e054-00144ff8d46c 43063-439 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate TABLET ORAL 19901101 ANDA ANDA081099 PD-Rx Pharmaceuticals, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 43063-440_559ff7bd-fbaf-5406-e054-00144ff88e88 43063-440 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19931223 ANDA ANDA076704 PD-Rx Pharmaceuticals, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43063-441_5b224f63-0923-4a80-e053-2991aa0aab25 43063-441 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43063-442_559ff7bd-fc27-5406-e054-00144ff88e88 43063-442 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19880617 ANDA ANDA072011 PD-Rx Pharmaceuticals, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43063-443_5bbea2fa-00b1-9f92-e053-2a91aa0aa798 43063-443 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 PD-Rx Pharmaceuticals, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-444_5bbea2fa-00f5-9f92-e053-2a91aa0aa798 43063-444 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 PD-Rx Pharmaceuticals, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-445_553809fa-8762-504c-e054-00144ff88e88 43063-445 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 PD-Rx Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-446_5c5242b4-977d-62f1-e053-2991aa0a0682 43063-446 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 PD-Rx Pharmaceuticals, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 43063-447_5f4abced-3e31-2517-e053-2991aa0a489e 43063-447 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 43063-451_5b71ddd8-203a-68c1-e053-2a91aa0a314f 43063-451 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA076048 PD-Rx Pharmaceuticals, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-453_082c5e5f-3cc2-401a-894b-0c81f8aae49f 43063-453 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-454_55ca2fa8-1049-27d4-e054-00144ff88e88 43063-454 HUMAN PRESCRIPTION DRUG Chloroquine Phosphate Chloroquine Phosphate TABLET, FILM COATED ORAL 20110315 ANDA ANDA090249 PD-Rx Pharmaceuticals, Inc. CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] N 20181231 43063-455_5b4b7990-a1cc-e139-e053-2a91aa0aba53 43063-455 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 PD-Rx Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 43063-457_5b4836b5-ea28-51ca-e053-2a91aa0a676f 43063-457 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 43063-458_63b19c49-91cb-7e64-e053-2a91aa0ac44b 43063-458 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 43063-459_5b4846bd-1115-78c0-e053-2991aa0ac67a 43063-459 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 43063-460_55395c2b-a158-0d26-e054-00144ff88e88 43063-460 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20061206 ANDA ANDA077563 PD-Rx Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43063-463_58eed335-5499-8f33-e053-2991aa0aad8c 43063-463 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 PD-Rx Pharmaceuticals, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 43063-465_5bb1621c-68e8-29ac-e053-2a91aa0a7eda 43063-465 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20050415 ANDA ANDA040555 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 43063-466_59187729-c16d-58fe-e053-2991aa0abe47 43063-466 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070501 ANDA ANDA065264 PD-Rx Pharmaceuticals, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-467_63658c76-de59-c04e-e053-2a91aa0ac711 43063-467 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 43063-468_5bab8b64-d506-b758-e053-2991aa0a743a 43063-468 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-470_63b34403-2ae7-2936-e053-2991aa0ae36e 43063-470 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110106 ANDA ANDA090899 PD-Rx Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 43063-472_5bbef129-1554-59f2-e053-2a91aa0a2a8c 43063-472 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA085161 PD-Rx Pharmaceuticals, Inc. PREDNISONE 20 mg/1 N 20181231 43063-473_55c99902-3d55-05e9-e054-00144ff8d46c 43063-473 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 PD-Rx Pharmaceuticals, Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-474_58ee2aef-50bd-bdb5-e053-2a91aa0a1753 43063-474 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-475_5bffa4e3-b421-23ec-e053-2a91aa0a266b 43063-475 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 43063-477_4f544c60-9872-271d-e054-00144ff88e88 43063-477 HUMAN PRESCRIPTION DRUG Losartan potassium losartan potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA077424 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43063-478_5cd9e862-3a96-75b9-e053-2991aa0a1de3 43063-478 HUMAN PRESCRIPTION DRUG Losartan potassium losartan potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA077424 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43063-479_5fb46fe4-e7d4-a93e-e053-2991aa0a4271 43063-479 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20110906 ANDA ANDA090199 PD-Rx Pharmaceuticals, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 43063-480_5ae5a856-e5b2-480e-e053-2a91aa0a6454 43063-480 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-481_62860e9a-9919-c974-e053-2a91aa0aec1a 43063-481 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 43063-482_60f4430f-e983-3312-e053-2a91aa0a92d1 43063-482 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20061004 ANDA ANDA077912 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-483_5e066f81-171e-5feb-e053-2991aa0ace39 43063-483 HUMAN PRESCRIPTION DRUG Losartan potassium losartan potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA077424 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43063-484_55a0a1e6-6ec8-69ab-e054-00144ff88e88 43063-484 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-485_55a0dee7-d94a-7072-e054-00144ff8d46c 43063-485 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-487_55a0f99b-01cd-742a-e054-00144ff88e88 43063-487 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-490_5b224f63-0911-4a80-e053-2991aa0aab25 43063-490 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43063-491_5bffb9e6-eebd-3795-e053-2a91aa0ad36e 43063-491 HUMAN PRESCRIPTION DRUG Losartan potassium and hydrochlorothiazide Losartan potassium and hydrochlorothiazide tablets TABLET, FILM COATED ORAL 20101006 ANDA ANDA077948 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43063-492_63b389b9-3f10-d715-e053-2a91aa0ad08e 43063-492 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20091216 ANDA ANDA040765 PD-Rx Pharmaceuticals, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20191231 43063-493_5b5c27a1-88dd-7513-e053-2a91aa0a114a 43063-493 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 PD-Rx Pharmaceuticals, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-494_63b51bc6-3c37-74f7-e053-2a91aa0a2103 43063-494 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 PD-Rx Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 43063-495_5bd49bb0-03ac-562c-e053-2a91aa0a19d8 43063-495 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous terazosin hydrochloride anhydrous CAPSULE ORAL 20130222 ANDA ANDA075140 PD-Rx Pharmaceuticals, Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43063-496_625f1083-6d0e-41ba-9587-21081e3ecd60 43063-496 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-497_5bc32d3a-c76d-6880-e053-2991aa0a84f4 43063-497 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-498_5e2165d9-a5e0-39a5-e053-2a91aa0ab598 43063-498 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20110425 ANDA ANDA090370 PD-Rx Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 43063-499_5b380b85-0dee-545d-e053-2991aa0af7d8 43063-499 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078858 PD-Rx Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43063-501_5b5c78f2-c9ee-4fa5-e053-2a91aa0a60b7 43063-501 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 PD-Rx Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 43063-502_5b606634-9305-b9ab-e053-2991aa0a3786 43063-502 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 PD-Rx Pharmaceuticals, Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-505_5e218764-e6f1-85b3-e053-2a91aa0a871c 43063-505 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080606 ANDA ANDA078829 PD-Rx Pharmaceuticals, Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 43063-506_55ca3087-fa68-1bff-e054-00144ff88e88 43063-506 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110718 ANDA ANDA065509 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 43063-507_5b5e1abb-f756-064a-e053-2991aa0aff0d 43063-507 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43063-509_55a098ad-ddf5-080a-e054-00144ff8d46c 43063-509 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 PD-Rx Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 43063-510_5e06b9bb-5cd5-784f-e053-2991aa0ac41b 43063-510 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 PD-Rx Pharmaceuticals, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 43063-511_5e21a2d7-a421-3375-e053-2991aa0a71c3 43063-511 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-512_5bffb9e6-ef01-3795-e053-2a91aa0ad36e 43063-512 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-516_63b5820c-83de-474a-e053-2991aa0a579a 43063-516 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 PD-Rx Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 43063-518_5bea4b07-20dc-bf8a-e053-2991aa0a3e2c 43063-518 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040787 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 43063-519_553c604c-ac41-5ae1-e054-00144ff8d46c 43063-519 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040788 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 43063-520_6403f4cf-5cc5-458b-e053-2a91aa0accbd 43063-520 HUMAN PRESCRIPTION DRUG clarithromycin clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140227 ANDA ANDA065145 PD-Rx Pharmaceuticals, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 43063-521_5b1dfcc7-937f-f1c5-e053-2991aa0ae182 43063-521 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-522_5f4aad97-6f6f-5504-e053-2991aa0ae59e 43063-522 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil HCl atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20120727 NDA AUTHORIZED GENERIC NDA021078 PD-Rx Pharmaceuticals, Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 43063-523_5fc47422-8dca-735a-e053-2991aa0a7553 43063-523 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131127 ANDA ANDA201447 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-526_5c763d0e-63cf-4e0e-e053-2991aa0a538b 43063-526 HUMAN PRESCRIPTION DRUG Comfort Pac with Meloxicam Meloxicam KIT 20100630 ANDA ANDA077918 PD-Rx Pharmaceuticals, Inc. N 20181231 43063-527_4f54e198-7dfe-70cd-e054-00144ff8d46c 43063-527 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43063-528_5d6a7266-fa3b-906e-e053-2991aa0a5fb8 43063-528 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131127 ANDA ANDA201447 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-529_5d052027-6b56-dcfe-e053-2a91aa0a64cf 43063-529 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20050207 NDA AUTHORIZED GENERIC NDA050641 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE 100 mg/1 N 20181231 43063-530_64043b8c-821d-680b-e053-2991aa0afec8 43063-530 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20050825 ANDA ANDA065136 PD-Rx Pharmaceuticals, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 43063-531_5e21bfed-2717-3721-e053-2a91aa0a2d5b 43063-531 HUMAN PRESCRIPTION DRUG Xartemis XR oxycodone hydrochloride and acetaminophen TABLET, COATED ORAL 20130430 20190531 NDA NDA204031 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-532_60b286f0-4672-6bd2-e053-2a91aa0a8623 43063-532 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride ER Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111024 ANDA ANDA091680 PD-Rx Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 43063-533_55b475df-962e-2746-e054-00144ff88e88 43063-533 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075511 PD-Rx Pharmaceuticals, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 43063-534_49d73038-522e-5196-e054-00144ff8d46c 43063-534 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20110425 ANDA ANDA090370 PD-Rx Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 43063-536_5fc47422-8dea-735a-e053-2991aa0a7553 43063-536 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110119 ANDA ANDA090836 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-537_578203e7-60ff-40ad-e053-2991aa0aa3d6 43063-537 HUMAN PRESCRIPTION DRUG SUPRAX cefixime CAPSULE ORAL 20130315 NDA NDA203195 PD-Rx Pharmaceuticals, Inc. CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-538_42ad6514-a257-461f-a5b2-294e5819902b 43063-538 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-539_5189c415-768c-0669-e054-00144ff88e88 43063-539 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43063-540_5c000b86-a722-9418-e053-2a91aa0ae690 43063-540 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065212 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 43063-541_64033c94-ddaa-1b97-e053-2991aa0a8966 43063-541 HUMAN PRESCRIPTION DRUG BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET ORAL 20100721 ANDA ANDA090968 PD-Rx Pharmaceuticals, Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20191231 43063-542_52a4376c-fb75-2ff4-e054-00144ff88e88 43063-542 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-543_5269da22-123b-3841-e054-00144ff88e88 43063-543 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960308 NDA AUTHORIZED GENERIC NDA020254 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-544_5b4ae155-8e64-7e38-e053-2a91aa0a127c 43063-544 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43063-545_5189760a-d2e0-10ae-e054-00144ff88e88 43063-545 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43063-546_56564ee8-2655-2b4c-e054-00144ff8d46c 43063-546 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43063-547_5b1fd0ef-2e46-fd26-e053-2991aa0a3c38 43063-547 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20091010 ANDA ANDA076126 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 43063-548_64049ddd-4d7b-f644-e053-2a91aa0a714d 43063-548 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 PD-Rx Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 43063-549_64059a09-c22c-19bc-e053-2991aa0a00ed 43063-549 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 PD-Rx Pharmaceuticals, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 43063-550_6414fab0-8d01-928e-e053-2a91aa0a7cb3 43063-550 HUMAN PRESCRIPTION DRUG Sildenafil sildenafil citrate TABLET, FILM COATED ORAL 20120927 NDA AUTHORIZED GENERIC NDA021845 PD-Rx Pharmaceuticals, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 43063-551_553ca1b5-b824-0e7c-e054-00144ff88e88 43063-551 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 PD-Rx Pharmaceuticals, Inc. HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] N 20181231 43063-553_591866e1-5737-28fd-e053-2991aa0a8b40 43063-553 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080423 ANDA ANDA065392 PD-Rx Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-554_641578cc-981f-6046-e053-2a91aa0a0076 43063-554 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 43063-555_592b4e83-79b9-7c0d-e053-2a91aa0a1f54 43063-555 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 20180430 NDA AUTHORIZED GENERIC NDA020998 PD-Rx Pharmaceuticals, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-557_5be79d4d-a9fa-4320-e053-2991aa0a1361 43063-557 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-558_5bd50c3e-0eec-e44d-e053-2a91aa0a62c1 43063-558 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20050325 ANDA ANDA077152 PD-Rx Pharmaceuticals, Inc. TERBUTALINE SULFATE 5 mg/1 N 20181231 43063-559_592bb042-567b-0d4f-e053-2991aa0afc69 43063-559 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 20180531 NDA AUTHORIZED GENERIC NDA020998 PD-Rx Pharmaceuticals, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-560_635f3672-dec6-cf18-e053-2a91aa0a1061 43063-560 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA078050 PD-Rx Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 43063-561_5d7e28c7-310d-c12e-e053-2991aa0a7800 43063-561 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA090529 PD-Rx Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 43063-562_5d7e4fa8-5692-1385-e053-2991aa0ad122 43063-562 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA090529 PD-Rx Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 43063-563_59a125f1-193f-e6ba-e053-2a91aa0aca3b 43063-563 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-564_5be79d4d-a9cf-4320-e053-2991aa0a1361 43063-564 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20101020 ANDA ANDA078925 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43063-565_5c8b4431-6865-0cd1-e053-2a91aa0a3a9d 43063-565 HUMAN PRESCRIPTION DRUG clarithromycin clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140227 ANDA ANDA065145 PD-Rx Pharmaceuticals, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 43063-566_59914a53-dbd0-fb0e-e053-2991aa0a4202 43063-566 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-567_41700565-5e25-4c91-9f92-09d7a6c788f0 43063-567 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 PD-Rx Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 43063-569_64162e07-525e-563f-e053-2991aa0a1db6 43063-569 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 43063-570_5e07630a-91ba-649b-e053-2991aa0af499 43063-570 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 PD-Rx Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-571_52f7c3d0-cf27-2ef8-e054-00144ff88e88 43063-571 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100205 ANDA ANDA078466 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43063-573_5beae2b4-8a72-be56-e053-2a91aa0acd5a 43063-573 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-574_5c3a615e-3e0c-a6b5-e053-2a91aa0a4dd6 43063-574 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-575_5bfcef35-9448-3544-e053-2a91aa0abb63 43063-575 HUMAN PRESCRIPTION DRUG Zonisamide zonisamide CAPSULE ORAL 20051223 ANDA ANDA077637 PD-Rx Pharmaceuticals, Inc. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 43063-576_5c631c90-c71d-2260-e053-2a91aa0a560e 43063-576 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-577_5c637b8b-bf54-467b-e053-2a91aa0a7413 43063-577 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20110516 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. SALSALATE 750 mg/1 N 20181231 43063-578_6417f158-1fb6-37ae-e053-2991aa0a4175 43063-578 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20030501 ANDA ANDA076004 PD-Rx Pharmaceuticals, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 43063-580_5b71b806-2025-a261-e053-2a91aa0a0fdf 43063-580 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20140129 NDA AUTHORIZED GENERIC NDA021085 PD-Rx Pharmaceuticals, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 43063-581_5c8c43f2-3221-ec15-e053-2a91aa0a98a9 43063-581 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 PD-Rx Pharmaceuticals, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 43063-582_5cc6415f-1b0a-3f4d-e053-2a91aa0adbd7 43063-582 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 PD-Rx Pharmaceuticals, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 43063-584_591940a7-3110-70d5-e053-2991aa0a1c37 43063-584 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20030725 ANDA ANDA065135 PD-Rx Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-585_5b70597d-eafe-6e8e-e053-2991aa0a2ade 43063-585 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20140129 NDA AUTHORIZED GENERIC NDA021085 PD-Rx Pharmaceuticals, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 43063-586_6418915b-018f-536c-e053-2991aa0a383d 43063-586 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 43063-587_6418cde9-6080-4ca1-e053-2991aa0a9170 43063-587 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 PD-Rx Pharmaceuticals, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 43063-588_5be76317-bece-0048-e053-2991aa0a61f9 43063-588 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 PD-Rx Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43063-589_5badbfc5-0267-156e-e053-2a91aa0a74ba 43063-589 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 PD-Rx Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 43063-590_5c3a615e-3e42-a6b5-e053-2a91aa0a4dd6 43063-590 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 PD-Rx Pharmaceuticals, Inc. PREDNISONE 20 mg/1 N 20181231 43063-591_5c623d44-7373-75e9-e053-2991aa0a98f1 43063-591 HUMAN PRESCRIPTION DRUG NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET, FILM COATED ORAL 20090729 ANDA ANDA076264 PD-Rx Pharmaceuticals, Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 43063-592_61f5df4c-e28b-ebaf-e053-2a91aa0aeb7f 43063-592 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070813 ANDA ANDA078050 PD-Rx Pharmaceuticals, Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 43063-593_5c4e0d7e-28d1-4f82-e053-2a91aa0a895c 43063-593 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20150812 ANDA ANDA077752 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-594_5c3a85d4-5ee2-680f-e053-2a91aa0a838b 43063-594 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 NDA NDA018851 PD-Rx Pharmaceuticals, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-595_5bab9397-b9f5-d309-e053-2991aa0a6612 43063-595 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070125 ANDA ANDA065352 PD-Rx Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-596_4ea17235-bd05-6b5a-e054-00144ff88e88 43063-596 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20130812 ANDA ANDA040526 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 43063-597_5a9518c0-6a32-2001-e053-2a91aa0ac388 43063-597 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140704 ANDA ANDA065418 PD-Rx Pharmaceuticals, Inc. CEFDINIR MONOHYDRATE 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-598_51c4f61b-9e2b-1dc2-e054-00144ff88e88 43063-598 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20140813 ANDA ANDA077137 PD-Rx Pharmaceuticals, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 43063-599_5c3a85d4-5f19-680f-e053-2a91aa0a838b 43063-599 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 PD-Rx Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 43063-600_5b4b9267-31de-1f82-e053-2991aa0a2fc5 43063-600 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 PD-Rx Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-601_5c3a89ef-a0c9-bb12-e053-2a91aa0aeb0b 43063-601 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE TABLET ORAL 20080507 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 43063-603_59192df1-424c-6e36-e053-2991aa0aa0de 43063-603 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140704 ANDA ANDA065418 PD-Rx Pharmaceuticals, Inc. CEFDINIR MONOHYDRATE 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-604_6419a937-9348-79c5-e053-2991aa0aba63 43063-604 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20191231 43063-605_5beaef3a-d52d-580d-e053-2991aa0a5912 43063-605 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-606_5b36572a-7481-fd61-e053-2a91aa0a7a02 43063-606 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-607_5bc065e4-a064-79b8-e053-2991aa0a46dd 43063-607 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 19961118 ANDA ANDA040185 PD-Rx Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 43063-608_5bbf8693-9d11-6195-e053-2991aa0ad0ab 43063-608 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 PD-Rx Pharmaceuticals, Inc. PREDNISONE 20 mg/1 N 20181231 43063-609_5fc3abdd-d426-c060-e053-2991aa0a0e8f 43063-609 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-610_5bbf6a31-bc43-4fc1-e053-2991aa0a2a39 43063-610 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 PD-Rx Pharmaceuticals, Inc. PREDNISONE 20 mg/1 N 20181231 43063-611_641999dc-69ae-3527-e053-2991aa0a1369 43063-611 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20121016 ANDA ANDA078926 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 43063-612_5be922c5-9911-6fc5-e053-2a91aa0a59b2 43063-612 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-613_5b357799-c150-ea06-e053-2991aa0a658f 43063-613 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-614_5c63ec90-7ea3-ca75-e053-2a91aa0af450 43063-614 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-615_5c6403f7-7b72-ec4b-e053-2a91aa0a9e03 43063-615 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070177 PD-Rx Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43063-616_5bd44e22-4d46-084f-e053-2a91aa0a4a2c 43063-616 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 PD-Rx Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 43063-617_5b479b04-ca37-94f2-e053-2991aa0ad44b 43063-617 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 PD-Rx Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43063-618_5baf303b-de3f-d39c-e053-2a91aa0aaef5 43063-618 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20150501 ANDA ANDA202038 PD-Rx Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 43063-619_59a5c673-93e7-4fcc-e053-2991aa0a5dea 43063-619 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19980324 ANDA ANDA075124 PD-Rx Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 43063-620_5c3a0284-c804-1951-e053-2991aa0a64d9 43063-620 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131216 ANDA ANDA079067 PD-Rx Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 43063-622_5c3aac66-dc1b-229e-e053-2991aa0ada5a 43063-622 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-623_641a5022-9acb-ce0f-e053-2a91aa0a8163 43063-623 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 PD-Rx Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 43063-624_60a077c7-110d-a519-e053-2991aa0afe3e 43063-624 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 PD-Rx Pharmaceuticals, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43063-625_59a5c673-941b-4fcc-e053-2991aa0a5dea 43063-625 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20150708 ANDA ANDA204446 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE 50 mg/1 N 20181231 43063-626_59a5c201-b13c-1fe0-e053-2a91aa0a8609 43063-626 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20150708 ANDA ANDA204446 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE 100 mg/1 N 20181231 43063-627_5b3268b1-d8f2-aad8-e053-2a91aa0a203c 43063-627 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040787 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 43063-629_5c3a85d4-5f2a-680f-e053-2a91aa0a838b 43063-629 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 PD-Rx Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 43063-630_61cf843a-a756-471b-e053-2991aa0a1542 43063-630 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 PD-Rx Pharmaceuticals, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 43063-631_5b1fd0ef-2ed8-fd26-e053-2991aa0a3c38 43063-631 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-632_5c3a9e49-91c3-dacb-e053-2a91aa0a1b3a 43063-632 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131216 ANDA ANDA079067 PD-Rx Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 43063-633_5bebf7d7-1661-98b5-e053-2a91aa0acd46 43063-633 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 PD-Rx Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-634_5ae561b0-bff2-6df3-e053-2a91aa0ac0ef 43063-634 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-635_5c3ad462-69ce-5d3b-e053-2991aa0a85d0 43063-635 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 43063-637_5b480ab2-4307-24e5-e053-2a91aa0aa969 43063-637 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 43063-638_6299847b-ca35-d686-e053-2a91aa0aaf61 43063-638 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20191231 43063-639_5c8b0ff2-bc88-e235-e053-2a91aa0ac8d0 43063-639 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 PD-Rx Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 43063-640_5b5e17e1-2bc0-58b8-e053-2a91aa0a0228 43063-640 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 PD-Rx Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43063-641_641a7be4-0952-1f65-e053-2a91aa0a259e 43063-641 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 PD-Rx Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 43063-642_61cfacf8-b10e-4e56-e053-2a91aa0ad851 43063-642 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 PD-Rx Pharmaceuticals, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 43063-643_5c3ad5e7-ed79-8be4-e053-2a91aa0a9edd 43063-643 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA080292 PD-Rx Pharmaceuticals, Inc. PREDNISONE 5 mg/1 N 20181231 43063-644_5c3af63e-220a-5887-e053-2a91aa0a7fef 43063-644 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA088832 PD-Rx Pharmaceuticals, Inc. PREDNISONE 10 mg/1 N 20181231 43063-645_5c3af63e-2236-5887-e053-2a91aa0a7fef 43063-645 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 PD-Rx Pharmaceuticals, Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 43063-646_5b4b58ae-ba5b-bb2a-e053-2a91aa0aaefa 43063-646 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20130416 ANDA ANDA202248 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 43063-647_5bc403c9-f13c-60d8-e053-2a91aa0aa656 43063-647 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070219 PD-Rx Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43063-648_5d801c0e-4331-d043-e053-2991aa0a244e 43063-648 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20100730 20180430 NDA NDA019781 PD-Rx Pharmaceuticals, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 43063-649_5bc0f883-285e-d106-e053-2a91aa0acb9e 43063-649 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20100730 NDA NDA019781 PD-Rx Pharmaceuticals, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 43063-650_5fc4970a-7e53-a9b2-e053-2991aa0a3939 43063-650 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 PD-Rx Pharmaceuticals, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-651_5c3af63e-2264-5887-e053-2a91aa0a7fef 43063-651 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 PD-Rx Pharmaceuticals, Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 43063-652_5bfb94e1-72d1-e1a5-e053-2a91aa0a7035 43063-652 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 PD-Rx Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 43063-653_4f41bd0d-449a-08b0-e054-00144ff8d46c 43063-653 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20140828 ANDA ANDA201278 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-654_5bb0721d-bb73-1905-e053-2a91aa0a09fe 43063-654 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 43063-655_61e3f2a8-7dda-2f0d-e053-2991aa0a3136 43063-655 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20151019 ANDA ANDA040616 PD-Rx Pharmaceuticals, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 43063-656_5ae5427f-c84c-2e02-e053-2991aa0a5c4e 43063-656 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET, FILM COATED ORAL 20101201 ANDA ANDA065496 PD-Rx Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-657_5ae51cd9-c778-0041-e053-2991aa0ac574 43063-657 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET, FILM COATED ORAL 20101201 ANDA ANDA065496 PD-Rx Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-659_5b1e8943-268c-68cf-e053-2a91aa0a9613 43063-659 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA201146 PD-Rx Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 43063-660_5c3af63e-228f-5887-e053-2a91aa0a7fef 43063-660 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 PD-Rx Pharmaceuticals, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-661_6283661e-a430-468e-e053-2991aa0aa2bd 43063-661 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130321 ANDA ANDA202389 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 43063-662_49b12d66-26cc-263d-e054-00144ff88e88 43063-662 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20120919 ANDA ANDA202640 PD-Rx Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 43063-663_5c3af63e-22ec-5887-e053-2a91aa0a7fef 43063-663 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA076862 PD-Rx Pharmaceuticals, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43063-664_5b21afa7-6880-a755-e053-2991aa0ab890 43063-664 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43063-665_5b224f63-0967-4a80-e053-2991aa0aab25 43063-665 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43063-666_5b1dfcc7-931a-f1c5-e053-2991aa0ae182 43063-666 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-667_5c3ad462-6a33-5d3b-e053-2991aa0a85d0 43063-667 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 PD-Rx Pharmaceuticals, Inc. BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 43063-668_5bd391d6-6a44-3925-e053-2a91aa0a2ffe 43063-668 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20130531 ANDA ANDA078380 PD-Rx Pharmaceuticals, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 43063-669_55a40688-7663-6e7b-e054-00144ff88e88 43063-669 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20150923 ANDA ANDA207446 PD-Rx Pharmaceuticals, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-670_5ae561b0-c00e-6df3-e053-2a91aa0ac0ef 43063-670 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-671_62ecc4d0-90aa-ad11-e053-2991aa0a0933 43063-671 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20030501 ANDA ANDA076004 PD-Rx Pharmaceuticals, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 43063-673_5b21afa7-68b8-a755-e053-2991aa0ab890 43063-673 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43063-674_5cd9f72e-9d27-0a91-e053-2991aa0a6c99 43063-674 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030129 ANDA ANDA076119 PD-Rx Pharmaceuticals, Inc. MIRTAZAPINE 15 mg/1 N 20181231 43063-675_5c3ad462-6a8a-5d3b-e053-2991aa0a85d0 43063-675 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 PD-Rx Pharmaceuticals, Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 43063-676_5c3ad462-6ab0-5d3b-e053-2991aa0a85d0 43063-676 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20140103 ANDA ANDA203814 PD-Rx Pharmaceuticals, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 43063-677_4daf913b-761a-69ca-e054-00144ff88e88 43063-677 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43063-678_5ae5427f-c882-2e02-e053-2991aa0a5c4e 43063-678 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43063-679_5c3b26a6-1b7f-8140-e053-2991aa0ac947 43063-679 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43063-680_5c3b26a6-1bad-8140-e053-2991aa0ac947 43063-680 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-681_5b1e8943-26b8-68cf-e053-2a91aa0a9613 43063-681 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20160429 ANDA ANDA204446 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE 100 mg/1 N 20181231 43063-682_5b1e8943-26d2-68cf-e053-2a91aa0a9613 43063-682 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20160429 ANDA ANDA204446 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE 50 mg/1 N 20181231 43063-683_5bc30c57-4428-3a4b-e053-2a91aa0a72b6 43063-683 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-684_5c3b26a6-1bbd-8140-e053-2991aa0ac947 43063-684 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 PD-Rx Pharmaceuticals, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-685_5d19fdc1-cde0-2603-e053-2991aa0a42a6 43063-685 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160412 ANDA ANDA202991 PD-Rx Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 43063-686_5cc7eaab-03e4-dece-e053-2a91aa0a8c93 43063-686 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160412 ANDA ANDA202991 PD-Rx Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 43063-687_540bf8e6-ef1d-2d89-e054-00144ff88e88 43063-687 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43063-688_5c3b4640-b663-1641-e053-2a91aa0a02e7 43063-688 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 PD-Rx Pharmaceuticals, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-689_5c3b1cce-f1e2-1ee0-e053-2a91aa0adfff 43063-689 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 PD-Rx Pharmaceuticals, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43063-692_5c3b1cce-f239-1ee0-e053-2a91aa0adfff 43063-692 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 PD-Rx Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-693_5b1e3a52-69f1-3fc0-e053-2991aa0aa1ed 43063-693 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-694_5b1e8943-264b-68cf-e053-2a91aa0a9613 43063-694 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-695_49104d62-ee8e-2a45-e054-00144ff8d46c 43063-695 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 PD-Rx Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 43063-696_62ec0723-9bde-1d11-e053-2991aa0a2522 43063-696 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 PD-Rx Pharmaceuticals, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 43063-697_5c3b6879-6b43-7933-e053-2a91aa0a86d8 43063-697 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120101 ANDA ANDA077911 PD-Rx Pharmaceuticals, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43063-698_5c3b4640-b6a0-1641-e053-2a91aa0a02e7 43063-698 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120101 ANDA ANDA077911 PD-Rx Pharmaceuticals, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43063-699_5c3b6879-6b83-7933-e053-2a91aa0a86d8 43063-699 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120101 ANDA ANDA077911 PD-Rx Pharmaceuticals, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43063-700_5c3b6879-6bc3-7933-e053-2a91aa0a86d8 43063-700 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065212 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 43063-701_5c3b6879-6bfb-7933-e053-2a91aa0a86d8 43063-701 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20150201 ANDA ANDA075090 PD-Rx Pharmaceuticals, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 43063-702_49104c59-b458-2df3-e054-00144ff88e88 43063-702 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 PD-Rx Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43063-703_480701d1-96a6-3c18-e054-00144ff8d46c 43063-703 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 PD-Rx Pharmaceuticals, Inc. PREDNISONE 20 mg/1 N 20181231 43063-704_5c3b588d-358b-576f-e053-2a91aa0a54d9 43063-704 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-706_5a9527cb-91e9-01e3-e053-2991aa0a9d54 43063-706 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20160803 ANDA ANDA040197 PD-Rx Pharmaceuticals, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 43063-707_4fa6b4c1-9252-10be-e054-00144ff8d46c 43063-707 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 PD-Rx Pharmaceuticals, Inc. MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 43063-708_5c3b99cb-e8ff-b4c4-e053-2991aa0ac61c 43063-708 HUMAN PRESCRIPTION DRUG PROMETHAZINE Promethazine Hydrochloride SUPPOSITORY RECTAL 20150217 ANDA ANDA040428 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 43063-709_5c3ba68e-bbd2-c326-e053-2a91aa0acd3b 43063-709 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19781211 NDA NDA008678 PD-Rx Pharmaceuticals, Inc. ISONIAZID 100 mg/1 Antimycobacterial [EPC] N 20181231 43063-710_5c3be3e4-4b67-1f70-e053-2991aa0aca7c 43063-710 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19781211 NDA NDA008678 PD-Rx Pharmaceuticals, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 43063-711_5b1e8943-26ec-68cf-e053-2a91aa0a9613 43063-711 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20160615 ANDA ANDA080704 PD-Rx Pharmaceuticals, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 43063-712_47689cb1-cce3-5b7a-e054-00144ff8d46c 43063-712 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 PD-Rx Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-713_4fd34bb1-73fe-3128-e054-00144ff88e88 43063-713 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150722 ANDA ANDA065399 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 43063-714_5c3bbf1d-79e2-5e76-e053-2991aa0aac5c 43063-714 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate Fludrocortisone Acetate TABLET ORAL 20030214 ANDA ANDA040425 PD-Rx Pharmaceuticals, Inc. FLUDROCORTISONE ACETATE .1 mg/1 N 20181231 43063-715_5ae4cc75-fa49-4b5d-e053-2991aa0ad418 43063-715 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150722 ANDA ANDA065399 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 43063-716_58252f15-4878-3061-e053-2a91aa0a2320 43063-716 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 PD-Rx Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43063-717_59b6f01f-d2bf-5d57-e053-2991aa0a8d13 43063-717 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20160803 ANDA ANDA040197 PD-Rx Pharmaceuticals, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 43063-718_5b1e8943-25e6-68cf-e053-2a91aa0a9613 43063-718 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 19850904 ANDA ANDA070325 PD-Rx Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-719_4ea5c161-6621-01b6-e054-00144ff88e88 43063-719 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 PD-Rx Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 43063-721_5c3bbf1d-7a0b-5e76-e053-2991aa0aac5c 43063-721 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET ORAL 20140801 ANDA ANDA204476 PD-Rx Pharmaceuticals, Inc. PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] N 20181231 43063-721_5cda058a-306b-d3d7-e053-2a91aa0afef5 43063-721 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET ORAL 20140801 ANDA ANDA204476 PD-Rx Pharmaceuticals, Inc. PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] N 20181231 43063-722_5c3c10e2-999c-36bb-e053-2991aa0af247 43063-722 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20160718 ANDA ANDA073554 PD-Rx Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 43063-723_5c3c1ab7-96bb-6ca5-e053-2991aa0af2b9 43063-723 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 43063-725_5c3c1ab7-96ed-6ca5-e053-2991aa0af2b9 43063-725 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 PD-Rx Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43063-726_5c3c1ab7-971d-6ca5-e053-2991aa0af2b9 43063-726 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-727_62965985-10d1-2c62-e053-2991aa0a4024 43063-727 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 43063-728_5ae609e7-7d3b-d9f9-e053-2991aa0aed7c 43063-728 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150722 ANDA ANDA065398 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 43063-729_603bbd51-12d9-d857-e053-2a91aa0a4b7d 43063-729 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-730_46787da4-8d04-6c27-e054-00144ff8d46c 43063-730 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 PD-Rx Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 43063-731_5c3c3696-fd94-7532-e053-2a91aa0a2f58 43063-731 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 PD-Rx Pharmaceuticals, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-732_5cd9ff22-ada0-d7aa-e053-2991aa0a5393 43063-732 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070801 ANDA ANDA078314 PD-Rx Pharmaceuticals, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-733_5c3c4010-66b2-a554-e053-2991aa0ab992 43063-733 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-734_476c44da-e697-2f71-e054-00144ff8d46c 43063-734 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-735_5c5041fb-9f53-1d0a-e053-2a91aa0a7a01 43063-735 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43063-736_4c57f8e4-8403-749d-e054-00144ff88e88 43063-736 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20150402 ANDA ANDA065062 PD-Rx Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 43063-737_4715f267-d15d-116d-e054-00144ff8d46c 43063-737 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073516 PD-Rx Pharmaceuticals, Inc. KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-738_54b06071-f34f-5627-e054-00144ff8d46c 43063-738 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 PD-Rx Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 43063-739_476ade05-7780-1801-e054-00144ff88e88 43063-739 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 PD-Rx Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43063-740_477e5cea-ee91-6070-e054-00144ff88e88 43063-740 HUMAN PRESCRIPTION DRUG METHSCOPOLAMINE BROMIDE methscopolamine bromide TABLET ORAL 20131001 ANDA ANDA200602 PD-Rx Pharmaceuticals, Inc. METHSCOPOLAMINE BROMIDE 2.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 43063-741_477ef009-adec-6fd2-e054-00144ff88e88 43063-741 HUMAN PRESCRIPTION DRUG METHSCOPOLAMINE BROMIDE methscopolamine bromide TABLET ORAL 20131001 ANDA ANDA200602 PD-Rx Pharmaceuticals, Inc. METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 43063-742_47e48fe3-65fb-6813-e054-00144ff8d46c 43063-742 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 19980301 ANDA ANDA040268 PD-Rx Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 43063-743_64059185-b5d2-5cd2-e053-2991aa0a4f55 43063-743 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 PD-Rx Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 43063-744_481d8fca-b752-2009-e054-00144ff8d46c 43063-744 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160725 ANDA ANDA206674 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43063-745_602847fb-9dd6-b241-e053-2a91aa0a34ac 43063-745 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20161013 ANDA ANDA077836 PD-Rx Pharmaceuticals, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 43063-746_48c00b6d-2b72-27ec-e054-00144ff88e88 43063-746 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 PD-Rx Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 43063-747_49118e0b-92b1-65ce-e054-00144ff8d46c 43063-747 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43063-748_494a71e6-2d33-121e-e054-00144ff8d46c 43063-748 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20080522 ANDA ANDA078212 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43063-749_49c683d8-8dfb-6389-e054-00144ff8d46c 43063-749 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160412 ANDA ANDA202991 PD-Rx Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 43063-750_4d9d4306-f3c0-729c-e054-00144ff8d46c 43063-750 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43063-751_4bd08a06-50e3-0291-e054-00144ff88e88 43063-751 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071134 PD-Rx Pharmaceuticals, Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-752_620f5d9e-f351-8e5a-e053-2991aa0a7fff 43063-752 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20151204 ANDA ANDA203584 PD-Rx Pharmaceuticals, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 43063-753_4ce8bf61-e8c6-1ebc-e054-00144ff88e88 43063-753 HUMAN PRESCRIPTION DRUG Buprenorphine HCl Buprenorphine HCl TABLET SUBLINGUAL 20091008 ANDA ANDA078633 PD-Rx Pharmaceuticals, Inc. BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 43063-754_55a3a9b3-bf9b-5f67-e054-00144ff88e88 43063-754 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-755_5b6efe33-802a-41e9-e053-2a91aa0a93fd 43063-755 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43063-756_61f941e9-eaa0-990d-e053-2a91aa0ae4d6 43063-756 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET ORAL 20161120 ANDA ANDA205101 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 43063-757_61fa6e6b-48a8-5e0c-e053-2991aa0aa5d3 43063-757 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET ORAL 20161120 ANDA ANDA205101 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 43063-758_61fa5ce9-21cc-b68d-e053-2a91aa0aa878 43063-758 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160930 ANDA ANDA204989 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 43063-759_61e281ca-34c4-b356-e053-2a91aa0a582f 43063-759 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160930 ANDA ANDA204989 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 43063-760_61fb0daa-eea0-75f4-e053-2991aa0ae8f1 43063-760 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160930 ANDA ANDA204989 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 43063-761_505bc846-c776-4a69-e054-00144ff8d46c 43063-761 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43063-762_4eb81165-ba12-736d-e054-00144ff8d46c 43063-762 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20130411 ANDA ANDA202717 PD-Rx Pharmaceuticals, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 43063-763_61fb6230-a07c-71e9-e053-2991aa0a9be9 43063-763 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 43063-764_61fb8a6a-7de7-47f8-e053-2a91aa0a854c 43063-764 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 43063-765_61e1c13a-235f-e435-e053-2a91aa0a8c0b 43063-765 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 PD-Rx Pharmaceuticals, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 43063-766_4fa6fe3a-66c7-3b3a-e054-00144ff88e88 43063-766 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43063-767_4fe439c9-c91d-4250-e054-00144ff88e88 43063-767 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 43063-768_4fe44638-c539-7502-e054-00144ff8d46c 43063-768 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 PD-Rx Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 43063-769_5036e5b2-ac0c-331e-e054-00144ff88e88 43063-769 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-770_624be8fc-c0f8-4bd5-e053-2a91aa0a5e57 43063-770 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077535 PD-Rx Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 43063-771_6373edd5-7d3b-7e45-e053-2991aa0a6295 43063-771 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20150525 ANDA ANDA203047 PD-Rx Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 43063-772_52159413-ff52-13a3-e054-00144ff8d46c 43063-772 HUMAN PRESCRIPTION DRUG Contrave Extended-Release naltrexone hydrochloride and bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20141022 NDA NDA200063 PD-Rx Pharmaceuticals, Inc. NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE 8; 90 mg/1; mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA],Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43063-773_55d9d70d-b5e4-3568-e054-00144ff8d46c 43063-773 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 PD-Rx Pharmaceuticals, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-774_625a60d8-d053-faa3-e053-2991aa0ae4bd 43063-774 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018877 PD-Rx Pharmaceuticals, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20191231 43063-775_625ba59c-4507-73dc-e053-2a91aa0a0776 43063-775 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160930 ANDA ANDA204989 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 43063-776_625bd205-4aeb-52e1-e053-2991aa0ade0a 43063-776 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET ORAL 20161120 ANDA ANDA205101 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 43063-777_5d18f50b-b4cf-4db7-e053-2a91aa0a899f 43063-777 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 PD-Rx Pharmaceuticals, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43063-778_5fc40c67-b135-30c1-e053-2991aa0acb46 43063-778 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20100524 ANDA ANDA077135 PD-Rx Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 43063-779_563049cf-fc63-2941-e054-00144ff88e88 43063-779 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 43063-780_5a90447a-38e8-6919-e053-2991aa0a3f17 43063-780 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20131011 ANDA ANDA090549 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43063-782_5f4a9b4b-e8be-4487-e053-2991aa0a30a3 43063-782 HUMAN PRESCRIPTION DRUG Tramadol hydrochloride and acetaminophen Tramadol hydrochloride and acetaminophen TABLET ORAL 20140830 ANDA ANDA078778 PD-Rx Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 43063-783_5c38a61c-b0e1-26db-e053-2991aa0a3bb0 43063-783 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 PD-Rx Pharmaceuticals, Inc. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] N 20181231 43063-785_580fa129-d6ce-a7a3-e053-2991aa0a092f 43063-785 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161215 ANDA ANDA202557 PD-Rx Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 43063-786_5aaa8093-45f0-7ded-e053-2991aa0a5ae5 43063-786 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-787_5821d54c-a07c-0e46-e053-2991aa0a526c 43063-787 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43063-788_625cc4df-c5f4-f7d4-e053-2a91aa0aaa43 43063-788 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 PD-Rx Pharmaceuticals, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 43063-789_5aaa09ac-4383-503d-e053-2991aa0a3647 43063-789 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20050207 NDA AUTHORIZED GENERIC NDA050641 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE 50 mg/1 N 20181231 43063-790_59b8781d-869d-3f0e-e053-2a91aa0a257a 43063-790 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 PD-Rx Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 43063-791_5bd87dd5-6de0-ef0e-e053-2a91aa0a9261 43063-791 HUMAN PRESCRIPTION DRUG FOLIC ACID folic acid TABLET ORAL 20150804 ANDA ANDA204418 PD-Rx Pharmaceuticals, Inc. FOLIC ACID 1 mg/1 N 20181231 43063-792_625ce425-b607-22bd-e053-2a91aa0a27c8 43063-792 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 PD-Rx Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 43063-793_5c4dc03a-47d4-5a2f-e053-2a91aa0a9f99 43063-793 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018832 PD-Rx Pharmaceuticals, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 43063-794_5b325cde-2477-c510-e053-2991aa0af411 43063-794 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 PD-Rx Pharmaceuticals, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43063-795_5b248a4c-d720-b0dc-e053-2991aa0a2a59 43063-795 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091124 PD-Rx Pharmaceuticals, Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 43063-796_620f5d9e-f2ae-8e5a-e053-2991aa0a7fff 43063-796 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 N 20191231 43063-797_6326878f-dcb5-1143-e053-2a91aa0a11c1 43063-797 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 PD-Rx Pharmaceuticals, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 43063-798_61e22614-6579-36e5-e053-2991aa0aa485 43063-798 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040627 PD-Rx Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 43063-799_5bfe3f86-496f-47ee-e053-2a91aa0a17d1 43063-799 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040749 PD-Rx Pharmaceuticals, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 43063-800_5c87e7bf-4c6e-5714-e053-2a91aa0aace7 43063-800 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43063-801_5df8b0f9-ef05-f7c7-e053-2a91aa0a0de5 43063-801 HUMAN OTC DRUG Guaifenesin DM Guaifenesin and Dextromethorphan Hydrobromide TABLET ORAL 20171114 20271130 OTC MONOGRAPH FINAL part341 PD-Rx Pharmaceuticals, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 43063-802_5d074fe6-1e7f-40d8-e053-2a91aa0a7549 43063-802 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 PD-Rx Pharmaceuticals, Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 43063-804_6299cd20-2404-45b3-e053-2a91aa0aa4a8 43063-804 HUMAN OTC DRUG Meclizine 25 MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE ORAL 20171127 20271130 OTC MONOGRAPH FINAL part336 PD-Rx Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20191231 43063-805_603a7bd7-5079-db74-e053-2a91aa0a1bc2 43063-805 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 PD-Rx Pharmaceuticals, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43063-806_62ebabc8-2e3d-7b77-e053-2991aa0a16ef 43063-806 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19810827 NDA NDA018487 PD-Rx Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 43063-807_601568ee-2e78-3d25-e053-2a91aa0a66b7 43063-807 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170216 ANDA ANDA207068 PD-Rx Pharmaceuticals, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-808_60160d70-4de1-7df3-e053-2991aa0a5497 43063-808 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170216 ANDA ANDA207068 PD-Rx Pharmaceuticals, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43063-809_62ebbde0-1711-793f-e053-2991aa0ad64e 43063-809 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20130715 ANDA ANDA201972 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 43063-810_635efa33-1db2-e8a1-e053-2991aa0a1d03 43063-810 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170830 ANDA ANDA075743 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 43063-811_635efa33-1db2-e8a1-e053-2991aa0a1d03 43063-811 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170830 ANDA ANDA075743 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 43063-812_635efa33-1db2-e8a1-e053-2991aa0a1d03 43063-812 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170830 ANDA ANDA075743 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 43063-813_635efa33-1db2-e8a1-e053-2991aa0a1d03 43063-813 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170830 ANDA ANDA075743 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 43063-814_635efa33-1db2-e8a1-e053-2991aa0a1d03 43063-814 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170830 ANDA ANDA075743 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 43063-815_635efa33-1db2-e8a1-e053-2991aa0a1d03 43063-815 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170830 ANDA ANDA075743 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 43063-817_609fe66e-4906-5d3c-e053-2991aa0a88f5 43063-817 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 PD-Rx Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 43063-818_60dfd46d-189e-6c29-e053-2a91aa0ae380 43063-818 HUMAN OTC DRUG Docusate Sodium with Sennosides DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20171221 OTC MONOGRAPH NOT FINAL part334 PD-Rx Pharmaceuticals, Inc. DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 N 20181231 43063-819_61e6c263-242d-8330-e053-2991aa0ab25c 43063-819 HUMAN PRESCRIPTION DRUG Nature-Throid THYROID TABLET ORAL 20171227 20370131 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. THYROID, PORCINE 60 mg/1 N 20191231 43063-820_6490536e-0e42-8d5c-e053-2a91aa0a6c3f 43063-820 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 43063-821_6209b0fd-0fab-904b-e053-2991aa0a3359 43063-821 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 PD-Rx Pharmaceuticals, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 43063-822_624a1452-9b24-3135-e053-2a91aa0afc7c 43063-822 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 PD-Rx Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 43063-823_6258b68a-7dba-1fe5-e053-2991aa0a9b1e 43063-823 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20120725 ANDA ANDA065489 PD-Rx Pharmaceuticals, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 43063-824_6283724f-5a23-05b9-e053-2a91aa0ac135 43063-824 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20170501 ANDA ANDA205085 PD-Rx Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 43063-825_638b6974-1f75-d0db-e053-2a91aa0aeaed 43063-825 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 PD-Rx Pharmaceuticals, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 43063-826_6314c44a-c2f5-fa4c-e053-2a91aa0ae1b5 43063-826 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20060320 ANDA ANDA075677 PD-Rx Pharmaceuticals, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 43063-828_63745821-055e-7033-e053-2a91aa0a554c 43063-828 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 43063-829_64198af6-1e8e-4777-e053-2991aa0a8db6 43063-829 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 PD-Rx Pharmaceuticals, Inc. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 43063-831_63efa093-a4f2-51c4-e053-2a91aa0a618e 43063-831 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20150213 ANDA ANDA203027 PD-Rx Pharmaceuticals, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 43063-832_64144a95-c6f9-e1c3-e053-2991aa0a763c 43063-832 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170602 ANDA ANDA203512 PD-Rx Pharmaceuticals, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20191231 43063-833_643dccb7-c096-67bb-e053-2a91aa0a84c7 43063-833 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 PD-Rx Pharmaceuticals, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 43063-834_64901555-239f-ccf3-e053-2991aa0a7f3a 43063-834 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 20150420 ANDA ANDA074903 PD-Rx Pharmaceuticals, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 43066-150_a3edead0-46c6-4e1a-82e8-86874cb41d02 43066-150 HUMAN PRESCRIPTION DRUG Nexterone amiodarone hydrochloride INJECTION, SOLUTION INTRAVENOUS 20101116 NDA NDA022325 Baxter Healthcare Corporation AMIODARONE HYDROCHLORIDE 1.5 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 43066-360_a3edead0-46c6-4e1a-82e8-86874cb41d02 43066-360 HUMAN PRESCRIPTION DRUG Nexterone amiodarone hydrochloride INJECTION, SOLUTION INTRAVENOUS 20101116 NDA NDA022325 Baxter Healthcare Corporation AMIODARONE HYDROCHLORIDE 1.8 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 43068-101_acbaa136-7d9e-493d-95af-613f24bc58d9 43068-101 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20160501 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 43068-102_acbaa136-7d9e-493d-95af-613f24bc58d9 43068-102 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20160801 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 43068-104_acbaa136-7d9e-493d-95af-613f24bc58d9 43068-104 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20151215 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 43068-106_acbaa136-7d9e-493d-95af-613f24bc58d9 43068-106 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20160701 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] N 20181231 43068-108_acbaa136-7d9e-493d-95af-613f24bc58d9 43068-108 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20150915 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 8 mg/1 Atypical Antipsychotic [EPC] N 20181231 43068-110_acbaa136-7d9e-493d-95af-613f24bc58d9 43068-110 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20160115 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 43068-112_acbaa136-7d9e-493d-95af-613f24bc58d9 43068-112 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20161015 NDA NDA022192 Vanda Pharmaceuticals Inc. ILOPERIDONE 12 mg/1 Atypical Antipsychotic [EPC] N 20181231 43068-113_acbaa136-7d9e-493d-95af-613f24bc58d9 43068-113 HUMAN PRESCRIPTION DRUG Fanapt iloperidone KIT ORAL 20151201 NDA NDA022192 Vanda Pharmaceuticals Inc. N 20181231 43068-220_9dfa71b8-de12-491a-82cd-7ebb8a6f2823 43068-220 HUMAN PRESCRIPTION DRUG Hetlioz tasimelteon CAPSULE ORAL 20140404 NDA NDA205677 Vanda Pharmaceuticals Inc. TASIMELTEON 20 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] N 20181231 43071-100_3ee68abc-03ef-4b93-8e12-554368bdde3e 43071-100 HUMAN OTC DRUG MIRAE SKIN WITCH HAZEL SOAP TOPICAL 20110701 OTC MONOGRAPH FINAL part347 HUMAN AND NATURE CO., LTD. WITCH HAZEL .15 g/150g N 20181231 43071-110_cdf59ddd-5529-4a05-acc4-95c9ccda40a2 43071-110 HUMAN OTC DRUG MIRAE HAIR WITCH HAZEL SOAP TOPICAL 20110701 OTC MONOGRAPH FINAL part347 HUMAN AND NATURE CO., LTD. WITCH HAZEL .225 g/150g N 20181231 43071-120_70a81ab9-2dbe-4eb9-bdb4-fef8da70df24 43071-120 HUMAN OTC DRUG Mirae Magic Balm Witch Hazel, Oatmeal SOAP TOPICAL 20160201 OTC MONOGRAPH FINAL part347 HUMAN AND NATURE CO., LTD. WITCH HAZEL; OATMEAL 7.5; 1.5 g/50g; g/50g N 20181231 43072-001_18412891-9023-4e11-930b-75efe3bc9340 43072-001 HUMAN OTC DRUG FRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 AERIN LAUDER BEAUTY DIST. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .08175; .0436; .02725; .01199; .03597 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 43074-101_02e313a5-26b8-429f-a694-1ec91333eb89 43074-101 HUMAN OTC DRUG StaphWash Plus zinc acetate LIQUID TOPICAL 20100823 OTC MONOGRAPH FINAL part347 Phillips Company ZINC ACETATE .001 mg/mL E 20171231 43074-102_080bfc73-aee9-4752-97c0-8296a93f8c30 43074-102 HUMAN OTC DRUG Acneen SALICYLIC ACID LOTION TOPICAL 20101230 OTC MONOGRAPH FINAL part333D Phillips Company SALICYLIC ACID .02 mL/mL E 20171231 43074-103_255ddf24-7e33-471d-ab91-bc98652e760a 43074-103 HUMAN OTC DRUG TETRA-ABC TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20100824 OTC MONOGRAPH FINAL part333B Phillips Company TETRACYCLINE HYDROCHLORIDE .03 mg/mL E 20171231 43074-105_3b27d0ae-6e49-4b49-b67e-26a38fd9c76f 43074-105 HUMAN OTC DRUG StaphWash Plus zinc acetate LIQUID TOPICAL 20100823 OTC MONOGRAPH FINAL part347 Phillips Company ZINC ACETATE .001 mg/mL E 20171231 43074-108_683dc33c-ba75-4a12-acb1-e82d0ea98d78 43074-108 HUMAN OTC DRUG Dyabetex TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20100824 OTC MONOGRAPH FINAL part333B Phillips Company TETRACYCLINE HYDROCHLORIDE .03 mg/mL E 20171231 43074-110_607f1e90-14fe-4774-8b3d-e2276e92604c 43074-110 HUMAN OTC DRUG Acneclir SALICYLIC ACID LOTION TOPICAL 20101230 OTC MONOGRAPH FINAL part333D Phillips Company SALICYLIC ACID .02 mL/mL E 20171231 43074-111_50d6fcb2-68f1-4fa4-8f50-93b80a53e2e9 43074-111 HUMAN OTC DRUG Dermoneen SALICYLIC ACID LOTION TOPICAL 20110106 OTC MONOGRAPH FINAL part333D Phillips Company SALICYLIC ACID .02 mL/mL E 20171231 43074-112_f934f64d-4fc0-4344-85fa-51312257a591 43074-112 HUMAN OTC DRUG Diabecline TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20130610 OTC MONOGRAPH FINAL part333B Phillips Company TETRACYCLINE HYDROCHLORIDE 30 mg/g E 20171231 43074-113_44ab0779-170a-4870-9198-12efcbfdfdd8 43074-113 HUMAN OTC DRUG Ecoderm Colloidal Oatmeal LOTION TOPICAL 20101230 OTC MONOGRAPH FINAL part347 Phillips Company OATMEAL .001 mL/mL E 20171231 43074-114_94aab24d-fca0-490a-9eac-822490ac8a54 43074-114 HUMAN OTC DRUG Advanced Jellyfish Sting Kit zinc acetate POWDER, FOR SUSPENSION TOPICAL 20101112 OTC MONOGRAPH FINAL part347 Phillips Company ZINC ACETATE .001 mg/mL E 20171231 43074-115_280ce59e-9a59-4320-a51a-35fd4e1724e7 43074-115 HUMAN OTC DRUG Tetracycline-ABC TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20110215 OTC MONOGRAPH FINAL part333B Phillips Company TETRACYCLINE HYDROCHLORIDE .03 mg/mL E 20171231 43074-116_71e97088-421a-4286-a5de-3cd1561d8350 43074-116 HUMAN OTC DRUG Acnecycline TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20110215 OTC MONOGRAPH FINAL part333B Phillips Company TETRACYCLINE HYDROCHLORIDE .03 mg/mL E 20171231 43074-205_b7dccefd-6cf5-4dda-afa8-8cbeb7f9de64 43074-205 HUMAN OTC DRUG StingMed zinc acetate LIQUID TOPICAL 20100823 OTC MONOGRAPH FINAL part347 Phillips Company ZINC ACETATE .001 mg/mL E 20171231 43074-207_403d2eaa-af1c-4480-9408-b038bfd3625e 43074-207 HUMAN OTC DRUG VenomX zinc acetate LIQUID TOPICAL 20100823 OTC MONOGRAPH FINAL part347 Phillips Company ZINC ACETATE .001 mg/mL E 20171231 43074-208_72a4fe26-76fb-4381-8bf3-b7c11cbe2229 43074-208 HUMAN OTC DRUG IvyMed zinc acetate LIQUID TOPICAL 20100823 OTC MONOGRAPH FINAL part347 Phillips Company ZINC ACETATE .001 mg/mL E 20171231 43074-301_e739bfd8-0b05-48b3-859e-e6400d67b721 43074-301 HUMAN OTC DRUG TetraStem TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20140225 OTC MONOGRAPH FINAL part333B Phillips Company TETRACYCLINE HYDROCHLORIDE 30 mg/g E 20171231 43078-001_0b20db42-06c0-4f97-a05d-7f4b649fef29 43078-001 HUMAN OTC DRUG ARTHRI-SUPPORT menthol CREAM TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part348 Pure Science International, Inc. MENTHOL 5 g/100g E 20171231 43087-575_9ae4c5e2-0d0a-4bf3-9896-99c7c5fa59c4 43087-575 HUMAN OTC DRUG Puri-San Plus BENZETHONIUM CHLORIDE LIQUID TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part333 People's Janitorial Supply BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 43093-100_1262af65-982c-461a-92d6-d00841a1fb99 43093-100 HUMAN PRESCRIPTION DRUG Synapryn Tramadol Hydrochloride KIT ORAL 20090914 UNAPPROVED DRUG OTHER Fusion Pharmaceuticals LLC N 20181231 43093-101_28c7b9e3-07ca-6f9b-e054-00144ff88e88 43093-101 HUMAN PRESCRIPTION DRUG Tabradol Cyclobenzaprine Hydrochloride KIT ORAL 20090917 UNAPPROVED DRUG OTHER Fusion Pharmaceuticals LLC N 20181231 43093-104_24eae96d-b218-3c03-e054-00144ff8d46c 43093-104 HUMAN PRESCRIPTION DRUG Dicopanol Diphenhydramine Hydrochloride KIT ORAL 20100208 UNAPPROVED DRUG OTHER Fusion Pharmaceuticals LLC N 20181231 43093-105_24ea29f7-9f22-1bed-e054-00144ff8d46c 43093-105 HUMAN PRESCRIPTION DRUG Fanatrex Gabapentin KIT ORAL 20100515 UNAPPROVED DRUG OTHER California Pharmaceuticals LLC N 20181231 43097-575_8ecdad4c-c449-4617-b878-463ec33a9d61 43097-575 HUMAN OTC DRUG Puri-San Plus BENZETHONIUM CHLORIDE LIQUID TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part333 People's Janitorial Supply BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 43105-1000_d40221fc-75d4-4487-b153-5594e428d908 43105-1000 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19690101 UNAPPROVED MEDICAL GAS Liberty Health Supplies, LLC OXYGEN 99 L/100L N 20181231 43115-123_60efcfbb-bb46-24b9-e053-2a91aa0a9645 43115-123 HUMAN OTC DRUG NIA 24 SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20110609 OTC MONOGRAPH FINAL part352 Niadyne Inc HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 75; 50; 30; 26 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 43128-001_4fd9d819-6eaa-43b2-be81-a24af6714f10 43128-001 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A NDC, Inc. HYDROGEN PEROXIDE 30 mg/mL N 20181231 43128-002_fded95c9-a308-4bb8-a759-68fd728f7653 43128-002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A NDC, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 43128-005_bf504514-541f-4c94-a6b6-ea9694e01d22 43128-005 HUMAN PRESCRIPTION DRUG Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20150410 ANDA ANDA088387 NDC, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 43128-020_6f61cfcd-4857-45a1-9191-558144721ca3 43128-020 HUMAN PRESCRIPTION DRUG Topical Anesthetic Benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER NDC, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 43128-021_6f61cfcd-4857-45a1-9191-558144721ca3 43128-021 HUMAN PRESCRIPTION DRUG Topical Anesthetic Benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER NDC, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 43128-022_6f61cfcd-4857-45a1-9191-558144721ca3 43128-022 HUMAN PRESCRIPTION DRUG Topical Anesthetic Benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER NDC, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 43128-023_6f61cfcd-4857-45a1-9191-558144721ca3 43128-023 HUMAN PRESCRIPTION DRUG Topical Anesthetic Benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER NDC, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 43128-024_6f61cfcd-4857-45a1-9191-558144721ca3 43128-024 HUMAN PRESCRIPTION DRUG Topical Anesthetic Benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER NDC, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 43128-026_6f61cfcd-4857-45a1-9191-558144721ca3 43128-026 HUMAN PRESCRIPTION DRUG Topical Anesthetic Benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER NDC, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 43128-035_6287cb34-88b6-66d4-e053-2991aa0a840f 43128-035 HUMAN OTC DRUG Pro Advantage Fast Absorbing Perineal with Dimethicone Skin Protectant DIMETHICONE CREAM TOPICAL 20130307 OTC MONOGRAPH FINAL part347 NDC National Distribution & Contracting, Inc. DIMETHICONE 20 mg/mL N 20191231 43128-050_6286e9f4-fd66-7a02-e053-2991aa0a3ef6 43128-050 HUMAN OTC DRUG Alcohol Prep pad Isopropyl Alcohol SWAB TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333A NDC National Distribution & Contracting, Inc. ISOPROPYL ALCOHOL .7 mL/mL N 20191231 43128-101_10f7b4f0-4d7f-45f5-b188-99dc3a81993b 43128-101 HUMAN PRESCRIPTION DRUG ARTICAINE Articaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20150622 NDA NDA020971 NDC, Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 43128-102_2879227b-0be1-4d37-89cd-bda8e55d15c3 43128-102 HUMAN PRESCRIPTION DRUG ARTICAINE Articaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20151204 NDA NDA020971 NDC, Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 43128-105_2d6fd0c9-8f21-470a-8abd-0a3b907b698d 43128-105 HUMAN PRESCRIPTION DRUG LIDOCAINE Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20150410 ANDA ANDA088390 NDC, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 43128-108_6287bc3e-8b0a-45d3-e053-2991aa0aaa10 43128-108 HUMAN OTC DRUG Pro Advantage Antibacterial TRICLOSAN LIQUID TOPICAL 20130308 OTC MONOGRAPH NOT FINAL part333E NDC National Distribution & Contracting, Inc. TRICLOSAN 3 mg/mL N 20191231 43128-114_62876800-2b2b-4539-e053-2991aa0a6256 43128-114 HUMAN OTC DRUG Pro Advantage Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130308 OTC MONOGRAPH NOT FINAL part333E NDC National Distribution & Contracting, Inc. ALCOHOL 620 mg/mL N 20191231 43128-118_62868fdc-fa5b-5a27-e053-2991aa0a225d 43128-118 HUMAN OTC DRUG Pro Advantage Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20130308 OTC MONOGRAPH NOT FINAL part333E NDC National Distribution & Contracting, Inc. ALCOHOL 620 mg/mL N 20191231 43128-128_629c138f-dd11-6cc1-e053-2991aa0a8243 43128-128 HUMAN OTC DRUG Pro Advantage Antibacterial TRICLOSAN LIQUID TOPICAL 20130424 OTC MONOGRAPH NOT FINAL part333E NDC National Distribution & Contracting, Inc. TRICLOSAN 3 mg/.001L N 20191231 43136-819_a60735f0-28cf-41fa-a00b-c5be933bee4e 43136-819 HUMAN OTC DRUG Cortisone Cream Intensive Healing Hydrocortisone CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part348 Tai Guk Pharmaceutical Company, Limited HYDROCORTISONE 10 mg/g E 20171231 43196-207_36e630f3-c6fa-27aa-e054-00144ff8d46c 43196-207 HUMAN OTC DRUG Foaming Instant Hand Sanitizer with Aloe and Vitamin E Foaming Instant Hand Sanitizer with Aloe and Vitamin E SOLUTION TOPICAL 20160705 OTC MONOGRAPH NOT FINAL part333A OPI Correctional Industries BENZETHONIUM CHLORIDE 7.56 g/100mL E 20171231 43196-510_35e13ed0-1005-436c-8865-dffd9ac46316 43196-510 HUMAN OTC DRUG OPI Antiseptic Foaming Hand Cleaner chloroxylenol LIQUID TOPICAL 20110307 OTC MONOGRAPH NOT FINAL part333E OPI Correctional Industries CHLOROXYLENOL 15.75 g/1000mL E 20171231 43196-514_13af3e44-3912-4b77-a9f8-d9c1a5cf0093 43196-514 HUMAN OTC DRUG OPI Personal Care Supplies Instant Foaming Hand Sanitizer Non Alcohol Husky 514 SOLUTION TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part333 OPI Correctional Industries BENZALKONIUM CHLORIDE 1 g/1000mL E 20171231 43196-683_f58fbcaa-400e-4f71-876e-37877657fc50 43196-683 HUMAN OTC DRUG Foaming Sanitizing Hand benzalkonium chloride SOAP TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333E OPI Correctional Industries BENZALKONIUM CHLORIDE .003 mg/mL E 20171231 43199-011_a07f4e5d-c377-eb55-3ea1-641272daa209 43199-011 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL; SUBLINGUAL 20090921 UNAPPROVED DRUG OTHER County Line Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 43199-012_4aa53e13-637d-58a3-615a-38a9d13f43c0 43199-012 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET, ORALLY DISINTEGRATING ORAL 20090921 UNAPPROVED DRUG OTHER NOT_SPECIFIED County Line Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/1 N 20191231 43199-013_7e6894fc-a729-7211-832a-c9ca6cd25eaa 43199-013 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20091105 UNAPPROVED DRUG OTHER County Line Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 43199-014_29ca94e8-87e6-2190-5669-730d1853a9a7 43199-014 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Extended-Release Hyoscyamine Sulfate Extended-Release TABLET ORAL 20100103 UNAPPROVED DRUG OTHER County Line Pharmaceuticals, LLC HYOSCYAMINE SULFATE .375 mg/1 N 20181231 43199-020_bd608c6e-8e83-fb72-c140-29ae453f4982 43199-020 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20100503 NDA NDA016151 County Line Pharmaceuticals, LLC METHENAMINE HIPPURATE 1 g/1 N 20181231 43199-029_fbb7aee8-4131-780c-6449-f13864b0e21f 43199-029 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 20160906 NDA NDA016909 County Line Pharmaceuticals, LLC FLUOCINONIDE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43199-031_0d3fd16f-d940-70d2-978d-09e3d491df36 43199-031 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide SOLUTION TOPICAL 20140228 NDA NDA018849 County Line Pharmaceuticals, LLC FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43199-037_318b0f4e-5470-91d5-7960-09bf8244385d 43199-037 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride labetalol hydrochloride TABLET ORAL 20141201 NDA NDA018716 County Line Pharmaceuticals LLC LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43199-038_318b0f4e-5470-91d5-7960-09bf8244385d 43199-038 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride labetalol hydrochloride TABLET ORAL 20141201 NDA NDA018716 County Line Pharmaceuticals LLC LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43199-039_318b0f4e-5470-91d5-7960-09bf8244385d 43199-039 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride labetalol hydrochloride TABLET ORAL 20141201 NDA NDA018716 County Line Pharmaceuticals LLC LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43199-040_8c1c9f54-c031-50ac-8072-140ab4ff1c29 43199-040 HUMAN OTC DRUG Lidocaine Lidocaine CREAM TOPICAL 20140902 OTC MONOGRAPH NOT FINAL part348 County Line Pharmaceuticals, LLC LIDOCAINE 40 mg/g N 20181231 43199-041_6afd18ec-7527-a2dc-e33e-ff2e8040413e 43199-041 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160229 ANDA ANDA204772 County Line Pharmaceuticals, LLC METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43199-042_6afd18ec-7527-a2dc-e33e-ff2e8040413e 43199-042 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160229 ANDA ANDA204772 County Line Pharmaceuticals, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43199-053_038510e0-182e-cbf6-457f-5902f5f5ebfa 43199-053 HUMAN PRESCRIPTION DRUG Butalbital and Acetaminophen Butalbital and Acetaminophen TABLET ORAL 20151201 ANDA ANDA205120 County Line Pharmaceuticals, LLC ACETAMINOPHEN; BUTALBITAL 325; 50 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 43199-054_d86aab03-1839-173b-27d0-cee7c3426360 43199-054 HUMAN OTC DRUG Lidocaine Lidocaine CREAM TOPICAL 20150914 OTC MONOGRAPH FINAL part346 County Line Pharamceuticals LIDOCAINE 50 mg/g N 20181231 43199-056_4c8d9e30-7920-3bab-a92e-e0e50d0fc659 43199-056 HUMAN PRESCRIPTION DRUG Flecainide acetate Flecainide acetate TABLET ORAL 20161104 NDA NDA018830 County Line Pharmaceuticals, LLC FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] N 20181231 43199-057_4c8d9e30-7920-3bab-a92e-e0e50d0fc659 43199-057 HUMAN PRESCRIPTION DRUG Flecainide acetate Flecainide acetate TABLET ORAL 20161104 NDA NDA018830 County Line Pharmaceuticals, LLC FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 43199-058_4c8d9e30-7920-3bab-a92e-e0e50d0fc659 43199-058 HUMAN PRESCRIPTION DRUG Flecainide acetate Flecainide acetate TABLET ORAL 20161104 NDA NDA018830 County Line Pharmaceuticals, LLC FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 43203-852_9bbe693b-76f6-4ee4-b7ef-44c0452663ee 43203-852 HUMAN PRESCRIPTION DRUG Anticoagulant Citrate Dextrose A ACD-A Anticoagulant Citrate Dextrose A ACD-A INJECTION, SOLUTION EXTRACORPOREAL 20110511 ANDA BA110057 Arteriocyte Medical Systems, Inc. CITRIC ACID MONOHYDRATE; SODIUM CITRATE; DEXTROSE MONOHYDRATE .08; .22; .245 g/10mL; g/10mL; g/10mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 43219-001_825cd0c8-7ad5-44d0-988e-a26118aa504b 43219-001 HUMAN OTC DRUG Dr. Nona ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20170124 OTC MONOGRAPH FINAL part350 Emilia Cosmetics Ltd ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY .204 g/1.36g N 20181231 43219-002_26d57e7d-f1b1-4b19-ab0d-998a92ed6c66 43219-002 HUMAN OTC DRUG Laline Rich Hand Cream AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20170605 OTC MONOGRAPH NOT FINAL part352 Emilia Cosmetics Ltd AVOBENZONE; OCTOCRYLENE 3; 10 g/100g; g/100g N 20181231 43219-004_832a0e91-1007-4fb9-aa16-fd456c051c29 43219-004 HUMAN OTC DRUG emilia Broad Spectrum OCTINOXATE CREAM TOPICAL 20171001 OTC MONOGRAPH FINAL part352 Emilia Cosmetics Ltd OCTINOXATE 2 g/50mL N 20181231 43219-008_47954a12-b841-401d-858c-bdd885a5a3a4 43219-008 HUMAN OTC DRUG Public Goods TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20180204 OTC MONOGRAPH NOT FINAL part352 Emilia Cosmetics Ltd TITANIUM DIOXIDE; ZINC OXIDE 18; 9.5 g/236mL; g/236mL N 20191231 43219-042_2cb5c9b9-f124-4d77-9db8-e16b3a5c7b45 43219-042 HUMAN OTC DRUG Sunzee Face and Neck Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20180118 OTC MONOGRAPH NOT FINAL part352 Emilia Cosmetics Ltd TITANIUM DIOXIDE; ZINC OXIDE .076; .035 g/81mL; g/81mL N 20191231 43219-300_8e16ca17-7d9e-4468-9120-e4404c8b2186 43219-300 HUMAN OTC DRUG SUNZEE Broad Spectrum SPF 40 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170706 OTC MONOGRAPH NOT FINAL part352 Emilia Cosmetics Ltd TITANIUM DIOXIDE; ZINC OXIDE 2.56; 1.26 g/36mL; g/36mL N 20181231 43221-001_3dac8192-0b20-6f8c-e054-00144ff8d46c 43221-001 HUMAN OTC DRUG Epsom Salt magnesium sulfate GRANULE ORAL 20160905 OTC MONOGRAPH NOT FINAL part334 Frog Prince(China)Daily Chemicals Co., Ltd. MAGNESIUM SULFATE 100 g/100g E 20171231 43227-065_c18b8ba5-ffee-4575-86d7-ad45268da733 43227-065 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20060926 ANDA ANDA040653 Par Formulations Private Limited GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 43227-066_c18b8ba5-ffee-4575-86d7-ad45268da733 43227-066 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20060926 ANDA ANDA040653 Par Formulations Private Limited GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 43239-101_65dba14a-31fa-4eef-8853-e9462219a832 43239-101 HUMAN OTC DRUG SUNSCREEN SPF 30 ZINC OXIDE LOTION TOPICAL 20120318 OTC MONOGRAPH FINAL part352 ERBAVIVA INC. ZINC OXIDE 20 g/100g E 20171231 43239-201_dc672b9a-24c6-40b7-95a7-de12e027adb4 43239-201 HUMAN OTC DRUG SUNSCREEN SPF 30 ZINC OXIDE LOTION TOPICAL 20120710 OTC MONOGRAPH FINAL part352 ERBAVIVA INC. ZINC OXIDE 20 g/100g E 20171231 43251-0857_5b048c13-dd1e-4f69-9d21-c17805050053 43251-0857 HUMAN OTC DRUG Natralia Eczema Moisturizing OATMEAL LOTION TOPICAL 20141201 OTC MONOGRAPH FINAL part347 LaCorium Health USA Inc. OATMEAL 20 mg/mL E 20171231 43251-0864_37871023-f30a-473d-87ec-faf928f6ec98 43251-0864 HUMAN OTC DRUG Natralia Happy Little Bodies Eczema Relief OATMEAL CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 LaCorium Health USA Inc. OATMEAL 50 mg/g E 20171231 43251-0871_fbac51bf-0968-4506-90d5-3c56ec30da11 43251-0871 HUMAN OTC DRUG Natralia Happy Little Bodies Eczema Moisturizing Oatmeal LOTION TOPICAL 20140210 OTC MONOGRAPH FINAL part347 LaCorium Health USA Inc. OATMEAL 20 mg/mL E 20171231 43251-0888_248cf33f-dfb4-4cc8-989e-bb33c4da7bbe 43251-0888 HUMAN OTC DRUG Natralia Happy Little Bodies Eczema Body Wash Oatmeal GEL TOPICAL 20141201 OTC MONOGRAPH FINAL part347 LaCorium Health USA Inc. OATMEAL 10 mg/mL E 20171231 43251-2231_f268a8f9-84db-453a-8e1f-1b8c692724d2 43251-2231 HUMAN OTC DRUG Flexitol Naturals Eczema and Psoriasis Sodium Borate, Graphite, Potassium Sulfate, and Sodium Chloride CREAM TOPICAL 20090103 UNAPPROVED HOMEOPATHIC LaCorium Health International Pty Ltd SODIUM BORATE; GRAPHITE; POTASSIUM SULFATE; SODIUM CHLORIDE 20; 6; 3; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g E 20171231 43251-2241_24cc1f5a-9cdc-4dd3-bf59-33acd9cb6362 43251-2241 HUMAN OTC DRUG natralia eczema and psoriasis Sodium Borate, Graphite, Potassium Sulfate, and Sodium Chloride CREAM TOPICAL 20090301 UNAPPROVED HOMEOPATHIC LaCorium Health USA Inc. SODIUM BORATE; GRAPHITE; POTASSIUM SULFATE; SODIUM CHLORIDE 20; 6; 3; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43251-2281_b25244bc-84d5-4f2b-9ee4-a36de135c595 43251-2281 HUMAN OTC DRUG Natralia Eczema and Psoriasis Sodium Borate, Graphite, Potassium Sulfate, and Sodium Chloride GEL TOPICAL 20090103 UNAPPROVED HOMEOPATHIC LaCorium Health USA Inc. SODIUM BORATE; GRAPHITE; POTASSIUM SULFATE; SODIUM CHLORIDE 20; 6; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43251-3213_b76aa734-54d8-4a3f-aefd-963d68b1051c 43251-3213 HUMAN OTC DRUG Natralia Cramp Relief Methyl Salicylate GEL TOPICAL 20090301 UNAPPROVED DRUG OTHER Laderma Trading Pty Ltd METHYL SALICYLATE 105 mg/g E 20171231 43251-3323_134b3385-4249-41ba-98b8-f800cf994114 43251-3323 HUMAN OTC DRUG natralia acne wash SILICON DIOXIDE and SODIUM CHLORIDE LIQUID TOPICAL 20090301 UNAPPROVED HOMEOPATHIC LaCorium Health International Pty Ltd SILICON DIOXIDE; SODIUM CHLORIDE 3; 12 [hp_X]/mL; [hp_X]/mL E 20171231 43251-3333_b6a21ed9-7bb4-4fc5-b9be-d4b16eabe1fd 43251-3333 HUMAN OTC DRUG Natralia Acne CALENDULA OFFICINALIS FLOWER, CALCIUM CARBONATE, and PULSATILLA VULGARIS CREAM TOPICAL 20090301 UNAPPROVED HOMEOPATHIC LaCorium Health International Pty Ltd CALENDULA OFFICINALIS FLOWER; CALCIUM CARBONATE; PULSATILLA VULGARIS 6; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g E 20171231 43251-3340_32d36fb9-913b-4581-a2af-dc45211a4a4b 43251-3340 HUMAN OTC DRUG Flexitol Medicated Foot Tolnaftate CREAM TOPICAL 20120811 OTC MONOGRAPH FINAL part333C LaCorium Health International Pty Ltd TOLNAFTATE 1 g/100g E 20171231 43251-3345_e0ac2feb-c135-41da-8501-b7c85d5c5e9c 43251-3345 HUMAN OTC DRUG Natralia Anti-Itch Soothing OATMEAL and Menthol CREAM TOPICAL 20130110 OTC MONOGRAPH FINAL part347 LaCorium Health USA Inc OATMEAL; MENTHOL, UNSPECIFIED FORM 20; 6 mg/g; mg/g N 20181231 43251-3351_7a47e254-5846-47c7-8a7e-aad2484846ff 43251-3351 HUMAN OTC DRUG Flexitol Anti Fungal Undecylenic acid LIQUID TOPICAL 20090103 OTC MONOGRAPH FINAL part333C LaCorium Health International Pty Ltd UNDECYLENIC ACID 250 mg/mL E 20171231 43251-3353_34e2e253-4b67-42aa-97a9-7e1ec09bac1c 43251-3353 HUMAN OTC DRUG FLEXITOL FIRST AID ARNICA MONTANA FLOWER and CHAMOMILE SPRAY TOPICAL 20100312 UNAPPROVED DRUG OTHER Laderma Trading Pty Ltd ARNICA MONTANA FLOWER; CHAMOMILE 2; 2 mg/mL; mg/mL E 20171231 43251-3361_835610d3-ca3c-4326-a8dd-b970b5620f22 43251-3361 HUMAN OTC DRUG Natralia Anti Fungal Undecylenic acid LIQUID TOPICAL 20090103 OTC MONOGRAPH FINAL part333C Laderma Trading Pty Ltd UNDECYLENIC ACID 250 mg/mL E 20171231 43251-3363_85dcf98b-ee55-40cc-a95a-e567ec4e53c4 43251-3363 HUMAN OTC DRUG FLEXITOL FIRST AID ARNICA MONTANA FLOWER and CHAMOMILE CREAM TOPICAL 20100312 UNAPPROVED DRUG OTHER Laderma Trading Pty Ltd ARNICA MONTANA FLOWER; CHAMOMILE 2; 2 mg/g; mg/g E 20171231 43269-170_8d6289d0-f8c5-45d9-ac26-fafcc9e5b816 43269-170 HUMAN OTC DRUG SJ Antibacterial Hand Gel Ethyl Alcohol GEL TOPICAL 20091009 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-561_a859d2fa-e424-4156-9f2a-558c54bdf325 43269-561 HUMAN OTC DRUG SJ Antibacterial Hand Gel Ethyl Alcohol GEL TOPICAL 20091009 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-612_9855b35a-1ab5-4fde-a710-8cb22447d99d 43269-612 HUMAN OTC DRUG Target Fancy Nancy Antibacterial Hand Strawberry Parfait BENZALKONIUM CHLORIDE LOTION TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 g/100g E 20171231 43269-613_53c3f0cc-314d-4743-b41a-41b6e605b69c 43269-613 HUMAN OTC DRUG Target Fancy Nancy Antibacterial Hand Glamorous Grape BENZALKONIUM CHLORIDE LOTION TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 g/100g E 20171231 43269-614_e8f8b81e-4653-4a78-a755-a4518210c44e 43269-614 HUMAN OTC DRUG Claires Fancy Nancy Antibacterial Strawberry Parfait ALCOHOL GEL TOPICAL 20100519 OTC MONOGRAPH FINAL part333 SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-615_6639852c-e66e-4291-972a-8b9386ac27f8 43269-615 HUMAN OTC DRUG Claires Fancy Nancy Antibacterial Glamourous Grape ALCOHOL GEL TOPICAL 20100519 OTC MONOGRAPH FINAL part333 SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-616_6df0f3df-b831-4651-b43f-ced985402bd7 43269-616 HUMAN OTC DRUG Papaya Mango Antibacterial Hand Alcohol, Denatured GEL TOPICAL 20100611 OTC MONOGRAPH FINAL part333 SJ Creations, Inc. ALCOHOL 70 mL/100mL E 20171231 43269-617_bc12e227-891d-40f9-9345-d294b75e9d97 43269-617 HUMAN OTC DRUG Papaya Mango Antibacterial Hand Alcohol, Denatured GEL TOPICAL 20100611 OTC MONOGRAPH FINAL part333 SJ Creations, Inc. ALCOHOL 70 mL/100mL E 20171231 43269-618_da4c757a-b2d1-44c2-8751-7b312084d9c8 43269-618 HUMAN OTC DRUG Mandarin Nectar Antibacterial Foaming Handwash Triclosan LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-619_57f716ba-a0ca-444b-8bf9-55e33c69067f 43269-619 HUMAN OTC DRUG Mango Spice Antibacterial Foaming Handwash Triclosan LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-620_567d34ae-84c7-4f65-9760-f0968666d8ad 43269-620 HUMAN OTC DRUG Avocado Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-621_6fdd33a4-b1fd-4c27-8c65-eef736ee2ec8 43269-621 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Handwash Triclosan LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-622_e19a8204-751d-4cf4-8653-aa0833fb6249 43269-622 HUMAN OTC DRUG Sweet Fig Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-623_f5ddab1f-f0c4-4c66-bef9-dabcb53f6994 43269-623 HUMAN OTC DRUG Pineapple Pear Antibacterial Foaming Handwash Triclosan LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-624_fb05c259-56de-4b08-a4ad-746adc12d42a 43269-624 HUMAN OTC DRUG Witchs Brew Antibacterial Hand ALCOHOL GEL TOPICAL 20100623 OTC MONOGRAPH FINAL part333 SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-625_c6d40e85-4c58-47e9-9d4f-099818f3c24c 43269-625 HUMAN OTC DRUG Scaredy Cat Antibacterial Hand ALCOHOL GEL TOPICAL 20100623 OTC MONOGRAPH FINAL part333 SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-626_ce4a7e0d-cd8d-491a-9ff1-5c0c4462f950 43269-626 HUMAN OTC DRUG Antibacterial Hand - Witchs Brew and Scaredy Cat ALCOHOL KIT 20101019 OTC MONOGRAPH NOT FINAL part333E SJ CREATIONS E 20171231 43269-627_e46975c4-b24c-4b68-a61e-ee18644c4e40 43269-627 HUMAN OTC DRUG Antibacterial Hand Polar Mint and Arctic Blast ALCOHOL GEL TOPICAL 20100910 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-628_1bc980f1-6706-4978-b5aa-fafcffd7440c 43269-628 HUMAN OTC DRUG Antibacterial Hand Polar Mint ALCOHOL GEL TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-629_e4d88f68-9217-4def-92bd-4857bcbaf005 43269-629 HUMAN OTC DRUG Antibacterial Hand Arctic Blast ALCOHOL GEL TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-631_589e7e01-4fe8-425b-a806-ca262fc51414 43269-631 HUMAN OTC DRUG Antibacterial Hand Cranberry Spice BENZALKONIUM CHLORIDE LOTION TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 43269-632_d97c8161-6a1a-443f-b40d-2178f64932d0 43269-632 HUMAN OTC DRUG Antibacterial Hand Cranberry Spice ALCOHOL GEL TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-634_77d5d270-70f9-4787-ac48-ca4b1b3a5e63 43269-634 HUMAN OTC DRUG Antibacterial Hand Mistletoe and Mint BENZALKONIUM CHLORIDE LOTION TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 43269-635_c52b0a42-4102-4629-b121-e0945944fc20 43269-635 HUMAN OTC DRUG Antibacterial Hand Mistletoe and Mint ALCOHOL GEL TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-636_73d0ff31-6352-44e5-a137-884d441902f4 43269-636 HUMAN OTC DRUG Mandarin Nectar Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-637_37383a03-6786-485e-973b-effa4147e561 43269-637 HUMAN OTC DRUG Orange Cinnamon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-638_1a0c05b4-5c80-4af1-93b1-b1cda1eb1c9b 43269-638 HUMAN OTC DRUG Sweet Fig Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-639_a45b2a76-e8e3-4391-9cf9-a6229f5a5486 43269-639 HUMAN OTC DRUG Orange Clove Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-640_0e7fa435-1764-45e9-abdd-3ecce4ec998f 43269-640 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Olive Triclosan LIQUID TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-641_e5f0a52d-e7de-4676-a5b5-8f4ea8e92d02 43269-641 HUMAN OTC DRUG Antibacterial Hand Gift Set Icy Mint and Candy Cane ALCOHOL GEL TOPICAL 20100907 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-642_3a4710a4-0dce-4995-b02f-e6eb74ba1ca9 43269-642 HUMAN OTC DRUG Antibacterial Hand Icy Mint ALCOHOL GEL TOPICAL 20100907 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-643_390ff9df-8bad-41d4-bcb5-06262e1ed6b2 43269-643 HUMAN OTC DRUG Antibacterial Hand Candy Cane ALCOHOL GEL TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-645_737bafaf-4834-4950-85d8-eff5c0881cf8 43269-645 HUMAN OTC DRUG Antibacterial Hand Arctic blast ALCOHOL GEL TOPICAL 20100907 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-646_887b092b-3f37-4cbc-83d1-2b2759ed3c7e 43269-646 HUMAN OTC DRUG Antibacterial Hand Sugar Cookie BENZALKONIUM CHLORIDE LOTION TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 43269-648_f903b9a0-be74-4f32-86ee-e45cece2fd41 43269-648 HUMAN OTC DRUG Antibacterial Hand Gingerbread ALCOHOL GEL TOPICAL 20100909 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-649_aa8feffd-fbd8-4737-8237-b1dd0df08692 43269-649 HUMAN OTC DRUG Antibacterial Hand GB Sugar Cookie BENZALKONIUM CHLORIDE LOTION TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333 SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 43269-650_24de2f1c-d3c7-497b-b6a0-b27e9e5b44a1 43269-650 HUMAN OTC DRUG Sweet Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20101029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-652_7e5dd155-ce15-4dba-a1e1-b5accd37e645 43269-652 HUMAN OTC DRUG Mandarin Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20101102 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-653_f024a3e1-3c36-4bea-b899-495c60f97a56 43269-653 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20101102 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-655_c857fd1b-b27d-4585-b9c8-2a0e0ffccc66 43269-655 HUMAN OTC DRUG Vanilla Sugar Antibacterial Hand ALCOHOL GEL TOPICAL 20101109 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-656_3d1ba01d-048a-43ec-94f2-d4e7d41caab3 43269-656 HUMAN OTC DRUG Sweet Grape Antibacterial Hand ALCOHOL GEL TOPICAL 20101109 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-657_603011f0-7037-4abc-b6e0-1169df75ce8e 43269-657 HUMAN OTC DRUG Sun Blossom Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20101213 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-658_3bf03e81-c798-4e71-8d60-dfae5c2bed67 43269-658 HUMAN OTC DRUG Sandy Beaches Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20101213 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-659_483eaaa0-9176-41ec-b949-8637ba2d679a 43269-659 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20101213 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-660_83afc085-4392-4741-a64f-937352abe6db 43269-660 HUMAN OTC DRUG Jelly Bean Antibacterial Hand ALCOHOL GEL TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-661_410ee259-f3f8-437f-8e9b-b325d36e2c15 43269-661 HUMAN OTC DRUG Marshmallow Antibacterial Hand ALCOHOL GEL TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-662_22e64e7d-0c95-4b80-8983-b94c3e8d340f 43269-662 HUMAN OTC DRUG Creamsicle Antibacterial Hand BENZALKONIUM CHLORIDE LOTION TOPICAL 20110119 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 43269-663_178da967-7098-4809-b9a5-caf779d164d0 43269-663 HUMAN OTC DRUG Vanilla Bean Antibacterial Hand ALCOHOL GEL TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-664_de34dca9-5466-4222-9115-af4ba2f68861 43269-664 HUMAN OTC DRUG Orange Blossom Antibacterial Hand ALCOHOL GEL TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-665_c52c3897-c66b-424e-bbeb-2699a49cc677 43269-665 HUMAN OTC DRUG Jelly Bean Antibacterial Hand BENZALKONIUM CHLORIDE LOTION TOPICAL 20110119 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 43269-666_9bf07df6-15d6-465b-abd2-d2317a12c075 43269-666 HUMAN OTC DRUG Sea Mist Antibacterial Hand BENZALKONIUM CHLORIDE LOTION TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 43269-667_301ab715-ac35-4c85-a033-4ecfe9dc6f39 43269-667 HUMAN OTC DRUG Ocean Breeze Antibacterial Hand ALCOHOL GEL TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-668_eb8f43dd-440d-4c0e-925b-76f2bb418de2 43269-668 HUMAN OTC DRUG Ocean Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110215 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-669_0ad9ec15-ee9e-4896-8ed7-5a8926478265 43269-669 HUMAN OTC DRUG Kiwi Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-670_7340fe37-42eb-4ad6-b5ea-d3657e95ce03 43269-670 HUMAN OTC DRUG Pineapple Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-671_566b09ab-7b31-46f9-8041-2fca95cd95d9 43269-671 HUMAN OTC DRUG Citrus Burst Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-672_e76bd3ad-2ee2-4602-9296-a825e61ed953 43269-672 HUMAN OTC DRUG Olive Leaf Antibacterial Creamy Hand Wash Triclosan LIQUID TOPICAL 20110303 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-673_c299e93c-472c-4e91-8dc1-ca7332880712 43269-673 HUMAN OTC DRUG Citrus Basil Antibacterial Cleansing Hand Wash Triclosan LIQUID TOPICAL 20110302 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-674_9eafce74-9577-4cc0-83b9-848482dade6b 43269-674 HUMAN OTC DRUG Lemon Verbena Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20110303 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-675_11cc0e39-4125-43eb-8696-936e84346b58 43269-675 HUMAN OTC DRUG Island Banana Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-676_7457c39a-e06e-495d-93cb-9a9c34e745a1 43269-676 HUMAN OTC DRUG Citrus Basil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-677_130ca145-a362-40aa-9255-95c855c577e5 43269-677 HUMAN OTC DRUG Citrus Basil Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-678_25429827-f7f6-4f97-946d-cc9c91f50d7b 43269-678 HUMAN OTC DRUG Fresh Herbs Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20110404 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-679_cf82d4f4-6b64-4518-8862-8c66879bde6d 43269-679 HUMAN OTC DRUG Lemon Verbena Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-680_f70eff19-8ce6-4b37-ad41-568430368318 43269-680 HUMAN OTC DRUG Citrus Burst Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-681_88731459-e995-4795-995b-b017ad00c91d 43269-681 HUMAN OTC DRUG Creamy Peach Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-682_da4940d0-54e9-43cf-b43f-31d2b7b4e731 43269-682 HUMAN OTC DRUG Creamy Peach Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-684_a0a5a3cc-5da1-4ac1-8e8d-ee8e5302dd13 43269-684 HUMAN OTC DRUG Citrus Burst Antibacterial Cleansing Hand Wash Triclosan LIQUID TOPICAL 20110526 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-685_7cfb04c5-b021-40dc-9cbf-a552aeba331b 43269-685 HUMAN OTC DRUG Coconut Antibacterial Creamy Hand Wash Triclosan LIQUID TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-686_386333ac-6ea0-425d-9ccd-1e772adf882d 43269-686 HUMAN OTC DRUG Citrus Basil Antibacterial Creamy Hand Wash Triclosan LIQUID TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-687_b1564393-37b9-45f0-bb37-ff16a4c1d737 43269-687 HUMAN OTC DRUG Witches Brew Antibacterial Hand BENZALKONIUM CHLORIDE LOTION TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 43269-688_9ad2c7d2-a71a-4af7-886d-df01b4076749 43269-688 HUMAN OTC DRUG Boolicious Antibacterial Hand ALCOHOL GEL TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-689_c414ad4e-21af-4479-8f1f-40ad01b3d4a8 43269-689 HUMAN OTC DRUG Haunted Halloween Antibacterial Hand BENZALKONIUM CHLORIDE LOTION TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 43269-690_e2f1f740-3cf8-445e-9fa3-85a5ab9368c3 43269-690 HUMAN OTC DRUG Spooky Vanilla Antibacterial Hand ALCOHOL GEL TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-691_d98b55df-ae49-43d7-bbb6-af0f069c6854 43269-691 HUMAN OTC DRUG Wicked Candy Apple Antibacterial Hand BENZALKONIUM CHLORIDE LOTION TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 43269-692_be52cb57-7294-48da-a1f4-11a93abff844 43269-692 HUMAN OTC DRUG Trick or Treat Antibacterial Hand ALCOHOL GEL TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-693_b4767aa9-1d3d-4ce9-b985-52d9895752b3 43269-693 HUMAN OTC DRUG Trick or Treat Antibacterial Hand ALCOHOL GEL TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-694_4b7b969e-c38c-46f5-a54b-bb2b4db29341 43269-694 HUMAN OTC DRUG Boolicious Antibacterial Hand ALCOHOL GEL TOPICAL 20110630 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-695_dcfaf934-d525-46ec-91a5-c538f82cbc85 43269-695 HUMAN OTC DRUG Pumpkin Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110629 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-696_e511c1ce-1f72-4b9e-933c-18ba86936a45 43269-696 HUMAN OTC DRUG Avocado Olive Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110629 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-697_29acf775-9578-41d3-875f-512bd12ada34 43269-697 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110629 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-698_97281b4d-5fb0-4463-9d74-b37d7bed7d1a 43269-698 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-699_72933e6a-3e9e-460c-842b-f27a57659549 43269-699 HUMAN OTC DRUG Mulling Spices Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110726 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-700_b0e9a8fa-834c-4a29-b45e-398db73a4497 43269-700 HUMAN OTC DRUG Pomegranate Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-710_0e993e04-b5b8-4941-a4cd-e0b9a3c52c36 43269-710 HUMAN OTC DRUG Golden Pear Antibacterial Cleansing Hand Wash Triclosan LIQUID TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-711_862979a7-8c72-4e9d-9872-1ba66648df8d 43269-711 HUMAN OTC DRUG Mistletoe and Mint Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110726 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-712_5973b444-17c0-41ad-936e-445e32f23903 43269-712 HUMAN OTC DRUG Cranberry Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-713_852fe0fb-6919-4fcb-b44d-d3c006c67e21 43269-713 HUMAN OTC DRUG Orange Cinnamon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-714_080043ac-4f9f-44fc-9c35-58bf7c5a4275 43269-714 HUMAN OTC DRUG Pomegranate Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-715_537e38ee-0d30-4a5b-8e75-7aef4506eac1 43269-715 HUMAN OTC DRUG Kiwi Strawberry Foaming Hand Wash Triclosan LIQUID TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-716_c1fceb67-2a51-4c10-93ad-909ecd26cf85 43269-716 HUMAN OTC DRUG Citrus Burst Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-717_e1d3d80c-1fc0-4fc2-b919-4a19e306ac8c 43269-717 HUMAN OTC DRUG Olive Leaf Antibacterial Cleansing Hand Wash Triclosan LIQUID TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-718_430ceedf-0f47-4ba4-a35f-b724eda85d6d 43269-718 HUMAN OTC DRUG Paisley Peach Antibacterial Hand Moisturizer BENZALKONIUM CHLORIDE LOTION TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 43269-719_9189814d-617b-4c38-a12e-6558dbfb8c8e 43269-719 HUMAN OTC DRUG Daisy Blossom Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-720_8d561f9f-1c81-4b98-af23-cb7eb6ee5cba 43269-720 HUMAN OTC DRUG Sweet Water Antibacterial Hand Moisturizer BENZALKONIUM CHLORIDE LOTION TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 43269-721_9e5a778b-2c1d-4233-af2b-1382a17cd278 43269-721 HUMAN OTC DRUG Green Tea Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-723_5d5024c7-372c-470f-b07b-3218953d2939 43269-723 HUMAN OTC DRUG Pomegranate Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-724_bc9d88d6-a5d3-4397-bb8e-10b677dca6c1 43269-724 HUMAN OTC DRUG Orange Bliss Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-725_41d580dd-0267-4f8e-85a5-467cc138c967 43269-725 HUMAN OTC DRUG Citrus Burst Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-726_fc4428bc-3f3f-4be3-b592-c15ee30475d9 43269-726 HUMAN OTC DRUG Country Apple Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-727_2f600d63-c41d-494f-bb78-b766cdcf160d 43269-727 HUMAN OTC DRUG Honey Apple Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111206 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-728_4cac3d67-5d45-4066-92c4-bc50944036c9 43269-728 HUMAN OTC DRUG Lavender Sage Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-729_f62b7d63-255c-4bb3-9b6e-3c4fa2da575b 43269-729 HUMAN OTC DRUG Sandy Beaches Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-730_b01be39b-4fc8-46a2-8450-e194c06ffb78 43269-730 HUMAN OTC DRUG Island Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-731_af86f827-5de5-489b-b1d5-48afc1bf78c1 43269-731 HUMAN OTC DRUG Island Blossom Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-732_eef3940e-e8c8-4ccc-ac1f-2e75661559c5 43269-732 HUMAN OTC DRUG Citrus, Basil and Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-733_e79794fd-8106-46a5-acdd-ee8e3618c9e0 43269-733 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-734_3ce0c5fa-3b50-4529-bfea-35c01648e9cd 43269-734 HUMAN OTC DRUG Pomegranate Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-735_ee423e7f-e88b-4bf1-9118-49c215e4a1e0 43269-735 HUMAN OTC DRUG Papaya Mango Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120105 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-736_45cf764f-fe76-4127-bfff-2f4ed9806947 43269-736 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-737_3e72953c-0a1e-46e8-a191-e180992967ed 43269-737 HUMAN OTC DRUG Olive Oil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-738_cd7300a2-de2f-4608-aff1-6a570edc167a 43269-738 HUMAN OTC DRUG Pink Peony Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-739_a960d9cc-df2b-43d0-9429-8282384af38d 43269-739 HUMAN OTC DRUG Sandy Beaches Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-740_1c4ee3ac-7d6b-4e7d-951a-0abb6afbd5c1 43269-740 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-741_70de8734-b8f5-4cfe-b3fe-661267d7c065 43269-741 HUMAN OTC DRUG Sweet Papaya Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-742_16a019e1-2a93-4d72-9fe6-5139ae9d64b2 43269-742 HUMAN OTC DRUG Orange Basil and Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-743_72e14e78-ffea-4e9d-a8f1-ba45c37b5222 43269-743 HUMAN OTC DRUG Honey Vanilla Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-744_3cf0ce5b-00d1-4004-a323-ef439b370a3d 43269-744 HUMAN OTC DRUG Lavender and Sage Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-745_2372cd20-15ee-416e-9454-a5af5a7f32a2 43269-745 HUMAN OTC DRUG Sweet Daisy Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20120112 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-746_0dce062d-c669-4c99-a9b2-7f528275b394 43269-746 HUMAN OTC DRUG Vanilla Sugar Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20120112 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-747_e1d54e22-7d3b-4e26-aa0b-dcdaabd354dc 43269-747 HUMAN OTC DRUG Sweet Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120125 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-748_4313767c-93e5-488b-9dbd-402be9c78d16 43269-748 HUMAN OTC DRUG Lemon Verbena Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-749_71912693-8e16-4b5b-bd6f-78f640779daa 43269-749 HUMAN OTC DRUG Mandarin Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-750_bc5394ed-c908-4faf-b7ac-83cf90842de6 43269-750 HUMAN OTC DRUG Olive Oil and Lemon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-751_5640caf0-90e1-4245-804a-2129a19c2993 43269-751 HUMAN OTC DRUG Tuscan Lemon Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-752_58b533f5-7716-4b5b-8c7b-8b03354eb70d 43269-752 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-753_5873824e-66cb-41a4-8281-e76eee21c865 43269-753 HUMAN OTC DRUG Juicy Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-754_439224e6-9a1d-43aa-9223-625d907e349e 43269-754 HUMAN OTC DRUG Kiwi Strawberry Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-755_fff1b5f2-ee6a-44cb-9f69-0fc378d1f8eb 43269-755 HUMAN OTC DRUG Lemon Basil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-757_3c15ac70-86e9-4f0f-8ec5-f389ee0454e0 43269-757 HUMAN OTC DRUG Fresh Herbs Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-758_97ac88a6-c49d-4f5c-b2ea-5b88494b7f1b 43269-758 HUMAN OTC DRUG Sweet Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120220 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-759_78e7b3e4-8dc0-4aba-84c0-7d62206993f4 43269-759 HUMAN OTC DRUG Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20120305 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-760_79a55a89-af99-4dc9-8cb9-ea887a1703a1 43269-760 HUMAN OTC DRUG Citrus and Olive Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-761_47cc9f87-0962-4612-9d1f-50228f3595a5 43269-761 HUMAN OTC DRUG Summer Citrus Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-762_c73fee08-c67f-4c62-916b-1d886a4a61f4 43269-762 HUMAN OTC DRUG Basil and Plum Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-763_58140c5e-c858-4635-88f7-b68ab1d2f430 43269-763 HUMAN OTC DRUG Dewberry Burst Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-764_b52472e7-99f7-4331-866f-f06b22661b88 43269-764 HUMAN OTC DRUG Jasmine Mint Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-765_6c2af1f6-451c-4050-8372-dd8d7ba90f3b 43269-765 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-766_94e4fe2f-0d8b-4b87-b9f4-beaac3b9fea8 43269-766 HUMAN OTC DRUG Citrus Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-767_4bd11289-5e4f-47ee-bd8c-b81069b0a275 43269-767 HUMAN OTC DRUG Citrus Burst Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-768_f08e5fce-38df-461c-b3e3-c24d974ebb45 43269-768 HUMAN OTC DRUG Citrus Basil and Lime Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-769_92d33565-92eb-49de-b735-d3120142f4d1 43269-769 HUMAN OTC DRUG Lemon Drop Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-770_88dc71de-474e-4b56-9173-da22ee30e022 43269-770 HUMAN OTC DRUG Citrus and Casaba Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-771_e5ad7085-6916-4947-8a60-1c10757f7d2d 43269-771 HUMAN OTC DRUG Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20120322 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-772_767de4c0-54d3-41ab-9150-7a0e76787928 43269-772 HUMAN OTC DRUG Cucumber Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120420 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-773_59dfff19-3906-45b6-8077-04b27632f8bd 43269-773 HUMAN OTC DRUG Lemon Verbena Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120420 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-774_33791081-be76-404b-8708-cbbd77272b07 43269-774 HUMAN OTC DRUG Macaroon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120420 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-775_001143a2-47b8-467a-ace7-f60c34e83831 43269-775 HUMAN OTC DRUG Summer Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120420 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-776_1fea9639-355a-4e22-af72-6820fe2a7445 43269-776 HUMAN OTC DRUG Citrus Burst Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-777_d8be7e33-87ac-49a1-a3c8-439db1cc1dfa 43269-777 HUMAN OTC DRUG Citrus and Aloe Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-778_17b541ed-0914-49d3-8378-2af3f999ff19 43269-778 HUMAN OTC DRUG Cucumber and Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-779_8af1836b-f9c1-4371-af90-b1918b7454a6 43269-779 HUMAN OTC DRUG Vineyard Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-780_90ee8c86-6177-4c9e-968c-8f308d3e020f 43269-780 HUMAN OTC DRUG Fresh Linen Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-781_5b066d06-7243-4351-bf31-b6ae294a795a 43269-781 HUMAN OTC DRUG Island Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-782_0d59bc33-4f0e-4932-822d-22d779ed9dd9 43269-782 HUMAN OTC DRUG Summer Bouquet Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-783_282a4fe0-7aa9-4bb4-a7df-5df28b35e14b 43269-783 HUMAN OTC DRUG Apple Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-784_9470d3d0-143b-4123-a099-554d42fb796f 43269-784 HUMAN OTC DRUG Olive Oil and Lemon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-785_318b4ab0-937a-461a-a454-03d48489e6e4 43269-785 HUMAN OTC DRUG Summer Berry Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-786_08a094de-b9d6-4af0-a18a-c53f609c2ed0 43269-786 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-787_2a6ce1f6-3932-46e9-9c94-06a242ff0a03 43269-787 HUMAN OTC DRUG Lemon Fresh Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-788_43e78131-25b0-4dad-bb99-a76ae4c21118 43269-788 HUMAN OTC DRUG Pomegranate Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mL/100mL E 20171231 43269-790_017a1e04-740e-4b15-b8af-d450f5e824a1 43269-790 HUMAN OTC DRUG Spiced Cider Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-791_b11f801b-0ee9-4acc-af46-a0aaf5154fc3 43269-791 HUMAN OTC DRUG Pumpkin Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-792_f5e675b1-0ded-4b68-98e5-460532ce2dd4 43269-792 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-793_b34ed3c4-50ad-41bd-9963-873d27a21b74 43269-793 HUMAN OTC DRUG Autumn Medley Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-794_89a56adc-6bee-491c-ad79-746a0d410c97 43269-794 HUMAN OTC DRUG Mint and Aloe Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-795_4fa84e2b-3bda-42c4-a3b1-fdd6cf4b2cb3 43269-795 HUMAN OTC DRUG Pumpkin Spice Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20120703 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-796_b9649d9b-2972-497e-a7ff-b979e97aba1d 43269-796 HUMAN OTC DRUG Spooky Vanilla Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20120703 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mL/100mL E 20171231 43269-797_b5bfa7eb-9f77-4781-bd5a-976e299eb1eb 43269-797 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-798_b4e1badd-9255-42a8-81a4-cb45306af08b 43269-798 HUMAN OTC DRUG Cranberry Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-799_2a2d7b44-3217-4c7e-9f5f-8218b46e4d78 43269-799 HUMAN OTC DRUG Orange Blossom Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-800_37393fb2-1733-4dd2-a271-43c8567b7f19 43269-800 HUMAN OTC DRUG Ginger Blossom Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-801_5974190c-1ad8-4fcd-98b0-bb435d77d0f7 43269-801 HUMAN OTC DRUG Fresh Lemon Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-802_e4b40a21-e9ab-4541-81e2-520f6378eb42 43269-802 HUMAN OTC DRUG Wild Strawberry Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-803_d46c09f0-1008-4c12-8421-09ef49b5f5bb 43269-803 HUMAN OTC DRUG Honey Vanilla Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-804_058c3aba-56f0-407d-9ad6-d77bfb982195 43269-804 HUMAN OTC DRUG Vineyard Grape Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-805_8507e78b-d549-467e-a1fb-a3c919684463 43269-805 HUMAN OTC DRUG Apple Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-806_a39b8091-d1e1-49bc-aa37-4e3c02d52d1b 43269-806 HUMAN OTC DRUG Fresh Blueberry Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-807_32e56689-51b2-452b-8399-12339681a280 43269-807 HUMAN OTC DRUG Cranberry Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-808_878e6bdb-9fb1-471b-a550-a32359c136f7 43269-808 HUMAN OTC DRUG Fresh Lemon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-809_780d8287-9a0b-4c60-944b-4065178f96cf 43269-809 HUMAN OTC DRUG Lemon Drop Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-810_f0e2eeb5-1b54-4905-8f5e-d3a04d632f7a 43269-810 HUMAN OTC DRUG Blueberry Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-811_0c2ea094-ed2b-4203-8a82-48a713ca6426 43269-811 HUMAN OTC DRUG Sweet Honey Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-812_06a8222d-f0f7-45eb-8a63-c72179dced1b 43269-812 HUMAN OTC DRUG Grape Vineyard Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-813_9ad214da-9432-4197-ae1f-e14e01bd6039 43269-813 HUMAN OTC DRUG Cinnamon and Cream Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-814_4d148b97-b2ec-487d-9455-2b5888c47573 43269-814 HUMAN OTC DRUG Apple Cider Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-815_ddfb0680-9173-4c06-a77a-8cc302ad634a 43269-815 HUMAN OTC DRUG Cinnamon Clove Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-816_f235a7af-780c-40b6-a16b-f3eb5bdb2950 43269-816 HUMAN OTC DRUG Iced Vanilla Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-817_f0ff6092-6ecc-4304-bf55-6bcdf17f951a 43269-817 HUMAN OTC DRUG Pomegranate Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-818_4dbad500-2957-4763-adc4-2ee9b389c6e9 43269-818 HUMAN OTC DRUG Vanilla Cream Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-819_2021a487-d00f-4feb-8738-5831a7e95dfe 43269-819 HUMAN OTC DRUG Pomegranate Spice Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-820_910e62c4-1ca8-4333-9023-788b400aeeb9 43269-820 HUMAN OTC DRUG Cranberry Cream Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-821_b286f7b1-35a3-4395-8599-787f6138ed52 43269-821 HUMAN OTC DRUG Sugar Cookie Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-822_17901d12-1b19-435b-9167-603f211875d7 43269-822 HUMAN OTC DRUG Lemongrass Tea Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-823_09230cb8-3d57-4949-a512-8d81fb590fd6 43269-823 HUMAN OTC DRUG Lemongrass Tea Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-824_9b558183-a77c-4e80-99f5-1b0da0fd6c41 43269-824 HUMAN OTC DRUG Cinnamon Sticks Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-825_200511bc-ac4b-4466-9502-36d9391f8d45 43269-825 HUMAN OTC DRUG Cranberry Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-826_1022db75-de29-432d-ae82-31e0e0b66d4d 43269-826 HUMAN OTC DRUG Sweet Golden Pear Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-827_f9eed34b-cb4e-4f43-bff6-0edb9f538b87 43269-827 HUMAN OTC DRUG Blueberry Dream Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-828_890159fa-d806-4d85-9a0d-89bda82b650d 43269-828 HUMAN OTC DRUG Vineyard Grape Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-829_56cc3935-8566-4001-ae32-c119a46e088d 43269-829 HUMAN OTC DRUG Lemon and Basil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-830_5e84212d-ad53-4df6-86da-86d86b3b04fe 43269-830 HUMAN OTC DRUG Ginger and Lemon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-831_d336932f-e53f-41f7-b3f4-fe3a3a3e2bfa 43269-831 HUMAN OTC DRUG Mint and Aloe Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-832_c192cc7c-f8e1-427e-9c3d-c0fa50ee7bbe 43269-832 HUMAN OTC DRUG Manderin Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120904 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-833_c6f0a2fd-22f6-45a0-ac46-65cbf6919e6a 43269-833 HUMAN OTC DRUG Sugar Cookie Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120905 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-834_586c3e57-17d7-484f-9c70-e6592b27cc79 43269-834 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-835_f39d47dc-534c-42ee-a762-9cc34c71bb8b 43269-835 HUMAN OTC DRUG Lemon Verbeba Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-836_5c7147c2-361b-421c-b535-562e101f96c8 43269-836 HUMAN OTC DRUG Sweet Fig Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-837_9bc06661-c7cb-4de9-b6f5-a239999f0d00 43269-837 HUMAN OTC DRUG Apple Cider Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-838_93b163c6-8a44-455a-856d-b5fe44bcfd26 43269-838 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN .2 mg/100mL E 20171231 43269-839_6affcf17-b072-4397-b0d3-c8010b1c7729 43269-839 HUMAN OTC DRUG Citrus and Olive Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-840_de2742ae-017b-4a48-948c-8bd3f0f64be5 43269-840 HUMAN OTC DRUG Tuscan Lemon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-841_5efc7460-9361-4fcb-bb9a-7914c86f220e 43269-841 HUMAN OTC DRUG Fresh Herbs Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-842_bff82f50-b4f1-458b-ba79-ec225e47c724 43269-842 HUMAN OTC DRUG Ginger Blossom Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-843_8649a672-261d-44fe-876f-a680b18a4ccf 43269-843 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-844_e8783840-d614-4780-b45c-1e53e066fe0e 43269-844 HUMAN OTC DRUG Passion Flower Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-845_3060fabf-5ca9-4a62-bb60-8c23f7a46bbc 43269-845 HUMAN OTC DRUG Sea Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-846_6a3448fd-bf6f-45d4-862b-20b405a862c3 43269-846 HUMAN OTC DRUG Citrus Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-847_6d6afc79-459e-43c0-a239-fa133536ac46 43269-847 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-848_f8c6827c-ac11-4a74-b278-7ed65b371a2b 43269-848 HUMAN OTC DRUG Vanilla Honey Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-849_9ec4323b-f9b4-4705-a118-aa5e31f02bbd 43269-849 HUMAN OTC DRUG Apple Spice Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-850_e7f7e9d8-9177-4aec-994f-46c31cbce342 43269-850 HUMAN OTC DRUG Honey Almond Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-851_0091f9e7-e776-4f4f-91b0-e85e5ae8db2e 43269-851 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-852_5af744e2-8281-4cef-a8fa-37e9909f9e59 43269-852 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-853_21a0f79c-a139-43a3-8f7b-42872af1bcae 43269-853 HUMAN OTC DRUG Sage and Citrus Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-854_bcf94ee3-5452-463f-81db-60cbd38b8ba9 43269-854 HUMAN OTC DRUG Peaches and Cream Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-855_c05fcc04-8f0f-48a0-b16b-ffd39fd0894c 43269-855 HUMAN OTC DRUG Pomegranate Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-856_fb1087e8-1048-4938-8938-041672fa839a 43269-856 HUMAN OTC DRUG Citrus Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-857_f269de57-ce5d-40ac-9f0d-53dc8d6bf4a8 43269-857 HUMAN OTC DRUG Fresh Linen Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-858_f273db77-1668-4702-a702-72165919236e 43269-858 HUMAN OTC DRUG Fresh Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-859_a1669b59-6a33-4ba0-af9b-93e1bd4667f1 43269-859 HUMAN OTC DRUG Olive Oil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-860_1ff4c6e0-55f7-49c4-b455-0baa2cbd95c1 43269-860 HUMAN OTC DRUG Green Tea and Ginseng Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-861_0d0d1c10-10d2-4d80-a1cc-619810be647c 43269-861 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-862_60928ad3-b701-41fb-9277-d8938f371d42 43269-862 HUMAN OTC DRUG Sweet Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-863_56219b66-3441-48c4-8b33-e474dc9bb0ec 43269-863 HUMAN OTC DRUG Avocado Lime Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130218 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-864_7164b04b-b2a5-43b9-b7e7-9101532270f7 43269-864 HUMAN OTC DRUG Sweet Fig Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130218 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-865_88f01ed1-5227-4a53-b336-81b18f6e6b49 43269-865 HUMAN OTC DRUG Lemon Fresh Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130218 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-866_f767a2f4-63c4-4db2-9221-677ac2148738 43269-866 HUMAN OTC DRUG Fruit Medley Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130218 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-867_f81d7145-1e6f-4eb4-aac4-c3fa6bcc73c0 43269-867 HUMAN OTC DRUG Sweet Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130218 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-868_1cafd653-97e4-42e9-a17e-a55dfaa1e65b 43269-868 HUMAN OTC DRUG Cucumber Melon Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-869_8b72b5d5-5a7b-45bd-8fdc-582af87678de 43269-869 HUMAN OTC DRUG Mandarin Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-870_7bc0e2c2-b3c8-4152-a472-8a6ee5764dce 43269-870 HUMAN OTC DRUG French Vanilla and Lavender Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-871_caae74cb-b5b6-4bb5-823c-67e99b5e0749 43269-871 HUMAN OTC DRUG Lemon and Olive Oil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-872_208ae140-a310-4e48-b7aa-52ff1885cb4e 43269-872 HUMAN OTC DRUG Sweet Peaches Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-873_4894efc6-1205-4d1c-b5a9-1ee56d158cdb 43269-873 HUMAN OTC DRUG Lemon Verbena Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130319 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-874_7e49d446-7df6-41bb-a6ec-a91adacf86fe 43269-874 HUMAN OTC DRUG Island Breeze Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130416 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-875_050c632c-f382-46f0-b24a-7586a1041830 43269-875 HUMAN OTC DRUG Lavender Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130426 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-876_c8b84368-2093-4c5e-a92e-0caaa83d934e 43269-876 HUMAN OTC DRUG Lemon Zest Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130426 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-877_8ef416c4-49ff-4019-89ff-622ac11f7931 43269-877 HUMAN OTC DRUG Lemon and Basil Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130422 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-878_fe96506a-7a65-4db8-baa4-ecd374736bd6 43269-878 HUMAN OTC DRUG Mandarin Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130426 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-879_a8b049b3-d316-4456-a58b-c0adf56af0c5 43269-879 HUMAN OTC DRUG Sweet Red Apple Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130426 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-880_542aa87f-46c6-4ab1-917c-d87ea030d187 43269-880 HUMAN OTC DRUG Mischievous Orange Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130625 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-881_9e0f6f7f-c958-4798-88fe-256fcef1b546 43269-881 HUMAN OTC DRUG Pumpkin Seeds Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130625 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-882_da9d3c46-075d-4399-b04d-eea528e8a034 43269-882 HUMAN OTC DRUG Spooky Sugar Cookie Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130625 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-883_3347fc18-6091-47ce-9322-d11f4c6046c6 43269-883 HUMAN OTC DRUG Trick or Treat Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130625 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-884_b4d65276-e8e7-4b05-82fa-920dddb7f0ad 43269-884 HUMAN OTC DRUG Boolicious Antibacterial Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL .65 mg/100mL E 20171231 43269-885_f51f4bcc-6a4d-4680-97cb-19f3e4012782 43269-885 HUMAN OTC DRUG Boolicious Antibacterial Hand Moisturizer BENZALKONIUM CHLORIDE LOTION TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mg/100mL E 20171231 43269-886_6db0491c-1fbe-45d0-a896-e0fdc31d7800 43269-886 HUMAN OTC DRUG Spooky PUmpkin Antibacterial Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL .65 mg/100mL E 20171231 43269-887_9a99dd6b-ed3c-465b-aa4c-b5189bb4bcc9 43269-887 HUMAN OTC DRUG Spooky Pumpkin Antibacterial Hand Moisturizer BENZALKONIUM CHLORIDE LOTION TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE .13 mg/100mL E 20171231 43269-888_89cd51df-b787-4bf2-8e7b-fc4c802da901 43269-888 HUMAN OTC DRUG Haunted Halloween Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-889_1e24e577-77fc-4388-8fcf-298cc17f8cb4 43269-889 HUMAN OTC DRUG Spiced Pumpkin Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-890_1e85afac-7ba4-464e-a39a-8326e5878627 43269-890 HUMAN OTC DRUG Witchs Brew Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-891_c7b1e013-1ebb-478e-aeb2-a7bb648308ef 43269-891 HUMAN OTC DRUG Apple Cider Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-892_532b5245-7e9f-4052-b7e2-e4a3348e5644 43269-892 HUMAN OTC DRUG Golden Pear Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-893_7bf3b0cd-6bb8-4253-8dba-ca08790e6b83 43269-893 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-894_aabffcfc-1d8b-4b03-8399-c89fc3cd6a38 43269-894 HUMAN OTC DRUG Cranberry Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-895_25159486-8b00-487b-a3b7-adccb5d897fb 43269-895 HUMAN OTC DRUG Harvest Grape Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-896_2c38a83f-b043-407f-955f-a9f192d16b50 43269-896 HUMAN OTC DRUG Olive Leaf Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130802 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-897_b25da841-7c42-47fa-875b-cf7026c27011 43269-897 HUMAN OTC DRUG Holiday Treats Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-898_9ff2c718-1e0b-4064-941e-eb22ffb5b4f1 43269-898 HUMAN OTC DRUG Mistletoe and Mint Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-899_56d404ec-8c08-4a83-b84a-54eacc722303 43269-899 HUMAN OTC DRUG Snow Drop Antibacterial Foaming Hand Wash Triclosan LIQUID TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. TRICLOSAN 2 mg/mL E 20171231 43269-900_ae426089-b1fa-4551-8765-50497e67a9d1 43269-900 HUMAN OTC DRUG Mischievous Orange Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-901_b476c00f-b620-4d4a-9f68-a66576e3fcd3 43269-901 HUMAN OTC DRUG Pumpkin Seeds Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-902_c4d47585-c351-4e3c-bb2b-a28fb463bbb2 43269-902 HUMAN OTC DRUG Trick or Treat Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-903_4d5babd5-0781-4f7e-93c6-631eb1eb3ed9 43269-903 HUMAN OTC DRUG Blackberry Vanilla Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-904_d7a0fc90-1f5e-4f0c-b90a-5edabaa392d3 43269-904 HUMAN OTC DRUG Spooky Sugar Cookie Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-905_1d0379ee-cb30-47d6-9bb5-0901ade18316 43269-905 HUMAN OTC DRUG Holiday Treats Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140821 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-906_2deb800f-4593-42e2-8d24-a7683f7c5128 43269-906 HUMAN OTC DRUG Mistletoe and Mint Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140821 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-907_3003cbf3-de47-4b9e-bf74-7494aeee1030 43269-907 HUMAN OTC DRUG Cinnamon Spice Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140821 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-908_dacc164c-2de3-4baa-bd66-6d7ac5cb9b19 43269-908 HUMAN OTC DRUG Mistletoe Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20140821 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-909_fac272d6-16f3-4172-9d2f-1659087abe7e 43269-909 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20150209 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-910_2f90c530-5e30-4273-8020-db699babef5e 43269-910 HUMAN OTC DRUG Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20150211 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. ALCOHOL 65 mg/100mL E 20171231 43269-911_6d5a2872-94ae-4aed-9550-34bd144d4b1a 43269-911 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Mischievous Orange Benzalkonium Chloride LIQUID TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-912_01c3fb4b-4256-473b-b9e8-65ab37cda4f9 43269-912 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Spooky Sugar Cookie Benzalkonium Chloride LIQUID TOPICAL 20150610 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-913_466c845f-b076-4911-972c-23aabe559e86 43269-913 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Sweet Treats Benzalkonium Chloride LIQUID TOPICAL 20150610 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-914_d3bbdd8a-dfb0-434c-b217-3cf1eb19755d 43269-914 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Mischievous Orange Benzalkonium Chloride LIQUID TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-915_55e50e43-a071-4f36-b627-36e0f6f7381f 43269-915 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Spooky Sugar Cookie Benzalkonium Chloride LIQUID TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-916_c03626da-8714-4eef-b4d0-47e8adcabff5 43269-916 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Sweet Treats Benzalkonium Chloride LIQUID TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-917_1302ce09-c9c6-4bdf-8e82-a99134c267f6 43269-917 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Vanilla Booberry Benzalkonium Chloride LIQUID TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-918_79cc4516-5e2c-4bd9-92a9-efa0af896398 43269-918 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Holiday Treats Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-919_04761f83-4c45-43d5-bad5-cd016537be6e 43269-919 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Mistletoe and Mint Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-920_33259f8d-6c94-4828-a25b-c9c42e655c0d 43269-920 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Cinnamon Spice Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-921_e387f6cd-fa43-4b7c-b650-9a95d991c2dd 43269-921 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Cranberry Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-922_947bf48f-3a51-49f3-928e-7f5f45fa5479 43269-922 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Holiday Spice Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-923_2fdef397-483d-43cf-9272-e0e1e854cb3d 43269-923 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Holiday Spice Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43269-924_3e05960d-bba5-4ee2-af4e-3eb2e7339a05 43269-924 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Santa Berry Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E SJ Creations, Inc. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43276-0001_727ec7db-a658-428e-af99-6e6be273d668 43276-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090801 UNAPPROVED MEDICAL GAS Support Medical Company OXYGEN 99 L/100L E 20171231 43305-1030_fff2ba80-8f3d-4fd7-a021-073a4a69bcc6 43305-1030 HUMAN PRESCRIPTION DRUG LIDOCAINE HCl Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20120515 ANDA ANDA088390 Pearson Dental LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 43305-1080_1b5564d3-ab36-40c8-b3be-81e747929fc3 43305-1080 HUMAN PRESCRIPTION DRUG Pearson Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20120515 ANDA ANDA088387 Pearson Dental MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 43314-001_028d48ef-033d-49dc-8469-cde41d66ccf2 43314-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20030101 UNAPPROVED MEDICAL GAS Sound Oxygen Service, Inc. OXYGEN 99 L/100L E 20171231 43325-828_ee88367f-6d1a-4e52-8934-2d89323bd519 43325-828 HUMAN OTC DRUG LOreal Professionnel Paris Instant Clear Antidandruff Pyrithione Zinc SHAMPOO TOPICAL 20110303 OTC MONOGRAPH FINAL part358H L'Oreal Productos Capilares PYRITHIONE ZINC 5 mL/500mL E 20171231 43333-441_01f3ed96-0393-4e40-a2c7-8978462be22e 43333-441 HUMAN OTC DRUG Pumpkin Anti-bacterial foaming Hand Wash Benzethonium Chloride LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-442_50555de3-f554-469e-a5c7-e27a49b1747c 43333-442 HUMAN OTC DRUG Pear Anti-bacterial foaming Hand Wash Benzethonium Chloride LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-443_9b44d014-860b-4775-8039-3216214e9466 43333-443 HUMAN OTC DRUG Vanilla Bean Anti-bacterial foaming Hand Wash Benzethonium Chloride LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-444_3938a89d-9a83-44fd-8142-732908ff0d30 43333-444 HUMAN OTC DRUG Spice Anti-bacterial foaming Hand Wash Benzethonium Chloride LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-445_ded57d72-ed2b-4676-bae7-da81500b6070 43333-445 HUMAN OTC DRUG Clementine Anti-bacterial foaming Hand Wash Benzethonium Chloride LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-450_f8ac570e-813e-4051-9a5e-921c2c963da0 43333-450 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Benzalkonium Chloride LIQUID TOPICAL 20150317 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-451_a658466b-566e-45c8-80b4-cd6b8dd338b3 43333-451 HUMAN OTC DRUG Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20150316 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. ALCOHOL 65 mg/100mL E 20171231 43333-452_8c47c193-061b-4f50-b834-8db0f6d64f1a 43333-452 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Mischievous Orange Benzalkonium Chloride LIQUID TOPICAL 20150625 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-453_81e4e36f-efac-4737-9912-5802537f42ee 43333-453 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Spooky Sugar Cookie Benzalkonium Chloride LIQUID TOPICAL 20150625 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-454_7db8fd41-238c-4e45-8f90-030f72b81270 43333-454 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Sweet Treats Benzalkonium Chloride LIQUID TOPICAL 20150625 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-455_2d0ee4c3-b911-47a2-ab5c-f1b888f13f18 43333-455 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Mischievous Orange Benzalkonium Chloride LIQUID TOPICAL 20150625 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-456_fb64216c-4d1f-4bc8-9ee3-672c1587972d 43333-456 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Spooky Sugar Cookie Benzalkonium Chloride LIQUID TOPICAL 20150625 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-457_62663047-7d8a-466d-b028-c23911499539 43333-457 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Sweet Treats Benzalkonium Chloride LIQUID TOPICAL 20150625 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-458_3c744eba-96cf-41b6-af4c-7ee60c8ccac2 43333-458 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Vanilla Booberry Benzalkonium Chloride LIQUID TOPICAL 20150625 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-459_a4b388bf-a1df-4bf1-92a1-9fef76df8dbd 43333-459 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Holiday Treats Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-460_af05c685-0532-4bf8-b834-a1baa6be61cf 43333-460 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Mistletoe and Mint Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-461_d1a5899c-596a-4385-baaa-4e6f2cbdbf5d 43333-461 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Cinnamon Spice Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-462_b5448fcc-2fa5-4a7f-b58c-688419ccd3f5 43333-462 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Cranberry Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-463_499576e3-d39d-42bf-9508-3968e4ef1d54 43333-463 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Holiday Spice Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-464_6b0febaa-0ba6-4cff-90de-7202e540b0c1 43333-464 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Holiday Spice Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43333-465_4c1fcacc-d110-45cd-9b05-e10c05c372e9 43333-465 HUMAN OTC DRUG Antibacterial Foaming Hand Wash Santa Berry Benzalkonium Chloride LIQUID TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333E Tonic Bath and Body Products Shenzhen Ltd. BENZALKONIUM CHLORIDE 1 mg/13mL E 20171231 43337-9328_51f1bb6c-50b6-425e-b536-55c8c693f0fb 43337-9328 HUMAN OTC DRUG Stomachin Antacid Magnesium carbonate and Sodium bicarbonate CAPSULE ORAL 20090430 OTC MONOGRAPH NOT FINAL part331 Chang Kuo Chou Pharmaceutical Co. Ltd. MAGNESIUM CARBONATE; SODIUM BICARBONATE 58; 809 mg/g; mg/g E 20171231 43337-9329_e5c253c0-7968-40b1-87a7-cbbc1075dfd1 43337-9329 HUMAN OTC DRUG Stomachin Antacid Magnesium carbonate and Sodium bicarbonate POWDER ORAL 20090430 OTC MONOGRAPH FINAL part331 Chang Kuo Chou Pharmaceutical Co. Ltd. MAGNESIUM CARBONATE; SODIUM BICARBONATE 58; 809 mg/g; mg/g E 20171231 43345-002_09559804-a51c-40a6-9c06-43675309e416 43345-002 HUMAN OTC DRUG Preferred Plus Body Powder Menthol POWDER TOPICAL 20101031 OTC MONOGRAPH NOT FINAL part348 Aetna Felt Corp MENTHOL; ZINC OXIDE .17; 1.1 g/100g; g/100g E 20171231 43345-003_6443448f-36ac-46f1-b12e-c793b6b7017d 43345-003 HUMAN OTC DRUG Aetna Callus Remover Salicylic Acid PLASTER TOPICAL 19951031 OTC MONOGRAPH FINAL part358B Aetna Felt Corp SALICYLIC ACID .4 1/1001 N 20181231 43345-004_627c1a19-6a8b-48ce-839b-1a8e8e4e9e62 43345-004 HUMAN OTC DRUG Aetna Callus Remover Salicylic Acid PLASTER TOPICAL 19951031 OTC MONOGRAPH FINAL part358F Aetna Felt Corp SALICYLIC ACID 40 1/1 N 20181231 43347-158_93eec211-fc51-4117-8687-3aaaeb0517b1 43347-158 HUMAN OTC DRUG Thera Wise Natural Hemorrhoidal Witch Hazel OINTMENT RECTAL; TOPICAL 20160815 OTC MONOGRAPH FINAL part347 Derma Wise Skin Care Ltd. WITCH HAZEL 3.36 g/28g E 20171231 43347-172_65efcfe6-086f-48e2-a203-be0df061fbc2 43347-172 HUMAN OTC DRUG Thera Wise Natural Vapor Rub CAMPHOR (NATURAL) OINTMENT TOPICAL 20160815 OTC MONOGRAPH FINAL part341 Derma Wise Skin Care Ltd. CAMPHOR (NATURAL) 1.344 g/28g E 20171231 43347-189_3406bda0-a4a1-43f4-87b5-907244349a8b 43347-189 HUMAN OTC DRUG Thera Wise Natural Acne Salicylic Acid OINTMENT TOPICAL 20160815 OTC MONOGRAPH FINAL part333D Derma Wise Skin Care Ltd. SALICYLIC ACID .14 g/28g E 20171231 43353-001_0b1c30af-8a82-417f-be0a-aa3ec324e0d0 43353-001 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 Aphena Pharma Solutions - Tennessee, LLC FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 43353-004_02d04e01-a007-457d-9200-990cd737611e 43353-004 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-008_02d04e01-a007-457d-9200-990cd737611e 43353-008 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-009_60e6a8b2-92bc-4a12-9d15-67fa41d8d3dc 43353-009 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140315 ANDA ANDA203508 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-010_8ade0dd7-67ee-45f4-9713-95d3991a5bd9 43353-010 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 43353-011_ba04e9ec-26d0-4ec3-ba89-9443def0c189 43353-011 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140117 ANDA ANDA077745 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-013_6ce6ad15-ef05-4056-a630-897f4cc6d903 43353-013 HUMAN PRESCRIPTION DRUG tamsulosin hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20150105 ANDA ANDA078015 Aphena Pharma Solutions - Tennessee, LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-015_7a05b579-97d9-4b52-8998-b95a634e674e 43353-015 HUMAN PRESCRIPTION DRUG Azilect Rasagiline Mesylate TABLET ORAL 20060710 NDA NDA021641 Aphena Pharma Solutions - Tennessee, LLC RASAGILINE MESYLATE 1 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 43353-016_3f7bd8f6-2407-40e5-bdb0-c698313b5286 43353-016 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20130322 ANDA ANDA077118 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-018_6b8291f1-dcbd-4c61-92a4-9b1d35eeecdc 43353-018 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 43353-019_e1806901-2386-4ada-84a9-f20bc3c0edf2 43353-019 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 Aphena Pharma Solutions - Tennessee, LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-021_41fc64c4-7edd-4a3c-b4e0-7da421e375de 43353-021 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-023_41fc64c4-7edd-4a3c-b4e0-7da421e375de 43353-023 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-025_7431f3dd-bf89-4f5a-a9be-7118b0afbac9 43353-025 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Aphena Pharma Solutions - Tennessee, LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-026_6d7a5255-c615-4977-9825-103aff7327c4 43353-026 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076578 Aphena Pharma Solutions - Tennessee, LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 43353-027_2d3ce59f-9be8-43ca-bbf7-06ee7f55d047 43353-027 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Aphena Pharma Solutions - Tennessee, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 43353-028_41fc64c4-7edd-4a3c-b4e0-7da421e375de 43353-028 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-029_41fc64c4-7edd-4a3c-b4e0-7da421e375de 43353-029 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-030_41fc64c4-7edd-4a3c-b4e0-7da421e375de 43353-030 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-031_0291bd29-faa4-4aa9-83f6-7cb28c229413 43353-031 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Aphena Pharma Solutions - Tennessee, LLC ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-032_159645df-cd6b-46a3-842b-2d50c920a8de 43353-032 HUMAN PRESCRIPTION DRUG Tricor Fenofibrate TABLET ORAL 20041105 NDA NDA021656 Aphena Pharma Solutions - Tennessee, LLC FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 43353-033_41fc64c4-7edd-4a3c-b4e0-7da421e375de 43353-033 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-034_6919ba25-ae85-4fdc-b8d7-48ce9b26e3d5 43353-034 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE ORAL 20060327 ANDA ANDA076917 Aphena Pharma Solutions - Tennessee, LLC CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 43353-035_722b7796-becb-4bd0-ad66-ef8a4d7ff7b9 43353-035 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20091221 ANDA ANDA071995 Aphena Pharma Solutions - Tennessee, Inc. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-036_2c4d0ac3-c136-406d-b2e6-6cac93d3f0f5 43353-036 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Aphena Pharma Solutions - Tennessee, LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-038_8324e142-9886-4e2f-bfff-36667ddcc25a 43353-038 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20150414 ANDA ANDA077927 Aphena Pharma Solutions - Tennessee, LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-041_a33fd71a-4174-4989-82f2-6c8c39e187b3 43353-041 HUMAN OTC DRUG Sodium Bicarbonate sodium bicarbonate TABLET, ORALLY DISINTEGRATING ORAL 20120626 OTC MONOGRAPH FINAL part331 Aphena Pharma Solutions - Tennessee, LLC SODIUM BICARBONATE 650 mg/1 N 20181231 43353-044_dd91e884-3173-4572-9802-de20f7f6fc55 43353-044 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Aphena Pharma Solutions - Tennessee, LLC TADALAFIL 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 43353-049_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-049 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-050_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-050 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-051_fbc86929-65d6-455c-9176-be53dd3c3abf 43353-051 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET ORAL 20141212 NDA AUTHORIZED GENERIC NDA009768 Aphena Pharma Solutions - Tennessee, LLC HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 43353-053_41fc64c4-7edd-4a3c-b4e0-7da421e375de 43353-053 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-054_41fc64c4-7edd-4a3c-b4e0-7da421e375de 43353-054 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-059_0f5111d6-a380-40d6-ae3f-6fbcd975c962 43353-059 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140707 NDA AUTHORIZED GENERIC NDA021283 Aphena Pharma Solutions - Tennessee, LLC VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43353-060_fab5e5c3-4250-44c5-9a97-68a48e5330b2 43353-060 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20150209 ANDA ANDA076008 Aphena Pharma Solutions - Tennessee, LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 43353-061_e8c9f182-fcbd-49b2-bd85-7a5ff1060ac1 43353-061 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961101 NDA NDA018333 Aphena Pharma Solutions - Tennessee, LLC SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 43353-064_e28611de-9aba-468a-a3b8-aee278339402 43353-064 HUMAN PRESCRIPTION DRUG KLOR-CON potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140901 NDA NDA019123 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 43353-066_0f5111d6-a380-40d6-ae3f-6fbcd975c962 43353-066 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140707 NDA AUTHORIZED GENERIC NDA021283 Aphena Pharma Solutions - Tennessee, LLC VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43353-067_0f5111d6-a380-40d6-ae3f-6fbcd975c962 43353-067 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140707 NDA AUTHORIZED GENERIC NDA021283 Aphena Pharma Solutions - Tennessee, LLC VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43353-069_0b40530f-d489-4875-a93f-da7c1cff7316 43353-069 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43353-070_710cf772-574e-4ecd-a8aa-34190c719115 43353-070 HUMAN PRESCRIPTION DRUG ADCIRCA Tadalafil TABLET ORAL 20090522 NDA NDA022332 Aphena Pharma Solutions - Tennessee, LLC TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 43353-071_c5c4e65e-ba37-4215-ba30-9b7a3d66f27e 43353-071 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20150107 ANDA ANDA076071 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-072_5e1836c1-7b36-4ea5-8fa2-87e8d8d6b21f 43353-072 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Aphena Pharma Solutions - Tennessee, LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 43353-074_c1cede8c-12ef-4678-be73-35f8b16f2fe3 43353-074 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070102 ANDA ANDA072253 Aphena Pharma Solutions - Tennessee, Inc. OXAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-075_c53f4d79-df8d-42b8-86e3-bd6181049abc 43353-075 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43353-081_c53f4d79-df8d-42b8-86e3-bd6181049abc 43353-081 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43353-082_600cc6bc-4c96-40d8-8530-bfaaa5688510 43353-082 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130911 ANDA ANDA203769 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-083_a923a016-80b4-4a98-9494-ada455890843 43353-083 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE TABLET ORAL 20130227 NDA AUTHORIZED GENERIC NDA012462 Aphena Pharma Solutions - Tennessee, LLC DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 43353-084_39e1f574-b4d0-461a-9845-16f1ded3854a 43353-084 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 Aphena Pharma Solutions - Tennessee, LLC PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-085_a83d04b7-84f7-4967-9721-a82a0fe8d83e 43353-085 HUMAN PRESCRIPTION DRUG valproic acid valproic acid CAPSULE ORAL 20111029 ANDA ANDA073229 Aphena Pharma Solutions - Tennessee, LLC VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43353-088_1057a455-6bda-45a0-a521-8dd2acb8d3e3 43353-088 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20150209 ANDA ANDA071587 Aphena Pharma Solutions - Tennessee, LLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 43353-089_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-089 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-090_885cf4de-06f5-4acc-8feb-f61e7642b366 43353-090 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20100312 ANDA ANDA077836 Aphena Pharma Solutions - Tennessee, LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 43353-091_ed5be4fc-b241-4d4f-9c66-85d764eea8cd 43353-091 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Aphena Pharma Solutions - Tennessee, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-094_0fa7e671-91b0-4903-ad9a-11f538701b83 43353-094 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140520 ANDA ANDA201507 Aphena Pharma Solutions - Tennessee, LLC HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 43353-095_6e6fdfaa-8e30-4103-991d-fe0916d1eedf 43353-095 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Aphena Pharma Solutions - Tennessee, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-096_ed6d6ba2-96b7-4149-a6b8-85fe75f6f95a 43353-096 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-097_fcdcacb3-f8a2-4cef-beb0-316dc7485002 43353-097 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140515 ANDA ANDA091169 Aphena Pharma Solutions - Tennessee, LLC ESZOPICLONE 3 mg/1 CIV N 20181231 43353-098_bd07b82a-56ec-4c99-8372-53604e2e6ee6 43353-098 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA077064 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-101_fcdcacb3-f8a2-4cef-beb0-316dc7485002 43353-101 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140515 ANDA ANDA091169 Aphena Pharma Solutions - Tennessee, LLC ESZOPICLONE 2 mg/1 CIV N 20181231 43353-102_938fe460-8c8d-4c20-8895-15ac743ca861 43353-102 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20140220 ANDA ANDA203374 Aphena Pharma Solutions - Tennessee, LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 43353-103_5455d995-4fff-448f-8743-6e7bee209371 43353-103 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 19951130 ANDA ANDA040104 Aphena Pharma Solutions - Tennessee, LLC HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 43353-105_a828bab2-c41b-4a57-9ec9-626114437f4f 43353-105 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063065 Aphena Pharma Solutions - Tennessee, LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 43353-106_7431f3dd-bf89-4f5a-a9be-7118b0afbac9 43353-106 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Aphena Pharma Solutions - Tennessee, LLC DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-107_b6b43c41-f63d-4cff-930e-dc9ee7f9201e 43353-107 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 20090908 ANDA ANDA073229 Aphena Pharma Solutions - Tennessee, LLC VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43353-112_15b2d425-9b35-4453-b086-2a77d1d5af33 43353-112 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM TABLET ORAL 20121001 ANDA ANDA077534 Aphena Pharma Solutions - Tennessee, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-113_4caff724-4abc-435e-8e04-616f4d40f51c 43353-113 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-114_54921df4-d3d6-4ab2-aaf9-9789679c9f99 43353-114 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-115_0b2503ae-dca7-4c5f-8622-2c9366aab351 43353-115 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-120_7c3d6785-a4d8-4428-a5fe-bf4bb37c3cb1 43353-120 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130128 NDA AUTHORIZED GENERIC NDA020702 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-121_c5c4e65e-ba37-4215-ba30-9b7a3d66f27e 43353-121 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20150107 ANDA ANDA076071 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-123_7151035b-5ad2-423b-afbd-035b14699945 43353-123 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, EXTENDED RELEASE ORAL 20140822 ANDA ANDA075028 Aphena Pharma Solutions - Tennessee, LLC PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 43353-124_66435209-390b-4344-9b5b-47c9c2d92e2f 43353-124 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA089098 Aphena Pharma Solutions - Tennessee, LLC HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 43353-127_8324e142-9886-4e2f-bfff-36667ddcc25a 43353-127 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20150414 ANDA ANDA077927 Aphena Pharma Solutions - Tennessee, LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-128_2ac9368a-7105-4d2a-a6d7-a8b9c5c9bfce 43353-128 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-131_0bedfead-19aa-4149-ba58-4d0f189267b7 43353-131 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 Aphena Pharma Solutions - Tennessee, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 43353-132_8b8d0afd-873e-40cd-95e6-336eb2a4ca45 43353-132 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 43353-133_8b8d0afd-873e-40cd-95e6-336eb2a4ca45 43353-133 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 43353-138_acc9691a-1f0d-4799-b4fa-35e480ef8538 43353-138 HUMAN PRESCRIPTION DRUG CALCITRIOL CALCITRIOL CAPSULE ORAL 20090826 NDA AUTHORIZED GENERIC NDA018044 Aphena Pharma Solutions - Tennessee, LLC CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 43353-139_2f4be110-f156-465a-861d-fe406e0fd037 43353-139 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20150904 ANDA ANDA086925 Aphena Pharma Solutions - Tennessee, LLC ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 43353-140_d4065c9f-d681-4d49-af2b-a12985ca3e57 43353-140 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150728 ANDA ANDA078583 Aphena Pharma Solutions - Tennessee, LLC ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-141_2f4be110-f156-465a-861d-fe406e0fd037 43353-141 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20150904 ANDA ANDA087537 Aphena Pharma Solutions - Tennessee, LLC ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 43353-142_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-142 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-147_d4065c9f-d681-4d49-af2b-a12985ca3e57 43353-147 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150728 ANDA ANDA078583 Aphena Pharma Solutions - Tennessee, LLC ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-148_d4065c9f-d681-4d49-af2b-a12985ca3e57 43353-148 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150728 ANDA ANDA078583 Aphena Pharma Solutions - Tennessee, LLC ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-149_800910de-96de-4c4c-8028-221b98c7d164 43353-149 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 43353-150_8b6810b1-c1d9-499e-82b9-95e6e30dd8e8 43353-150 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20150721 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-152_7e272f5a-86d5-48f5-92b5-50bc33f351b3 43353-152 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20150325 ANDA ANDA071457 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-153_8b6810b1-c1d9-499e-82b9-95e6e30dd8e8 43353-153 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20150721 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-155_8b6810b1-c1d9-499e-82b9-95e6e30dd8e8 43353-155 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20150721 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-156_8b8d0afd-873e-40cd-95e6-336eb2a4ca45 43353-156 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 43353-159_d22cfbf2-c9ef-43fc-b930-6716f9cc45eb 43353-159 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Aphena Pharma Solutions - Tennessee, LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 43353-160_8b8d0afd-873e-40cd-95e6-336eb2a4ca45 43353-160 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077316 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 43353-161_8b6810b1-c1d9-499e-82b9-95e6e30dd8e8 43353-161 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20150721 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-162_36d1abdc-f28b-4c0d-98ea-07718706c695 43353-162 HUMAN OTC DRUG SODIUM BICARBONATE SODIUM BICARBONATE TABLET ORAL 20150501 OTC MONOGRAPH FINAL part331 Aphena Pharma Solutions - Tennessee, LLC SODIUM BICARBONATE 650 mg/1 N 20181231 43353-163_224b9d46-7b74-4c9c-b94b-f5bcb4f5c4f5 43353-163 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 Aphena Pharma Solutions - Tennessee, LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 43353-164_224b9d46-7b74-4c9c-b94b-f5bcb4f5c4f5 43353-164 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 Aphena Pharma Solutions - Tennessee, LLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 43353-165_bd5eaa03-d2d2-4af4-855f-a3fa51a58b72 43353-165 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine hydrochloride TABLET, COATED ORAL 20151013 ANDA ANDA200891 Aphena Pharma Solutions - Tennessee, LLC MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 43353-167_e5134918-4fb4-4395-a5ec-8acb76d627d5 43353-167 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Aphena Pharma Solutions - Tennessee, LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 43353-168_c5c4e65e-ba37-4215-ba30-9b7a3d66f27e 43353-168 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20150107 ANDA ANDA076071 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-169_c5c4e65e-ba37-4215-ba30-9b7a3d66f27e 43353-169 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20150107 ANDA ANDA076071 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-170_93145fb7-cfd5-4f1c-bc86-5d3bcc4edddd 43353-170 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20150731 ANDA ANDA090043 Aphena Pharma Solutions - Tennessee, LLC MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 43353-172_ed662f55-b226-4b47-8004-a5ff89f91003 43353-172 HUMAN PRESCRIPTION DRUG Minocin minocycline hydrochloride CAPSULE, COATED PELLETS ORAL 19900531 NDA NDA050649 Aphena Pharma Solutions - Tennessee, LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 43353-178_b0d8a6ff-5163-4f29-abcd-8318b92bbef9 43353-178 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus CAPSULE, GELATIN COATED ORAL 19940408 NDA NDA050708 Aphena Pharma Solutions - Tennessee, LLC TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 43353-179_c5c4e65e-ba37-4215-ba30-9b7a3d66f27e 43353-179 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20150107 ANDA ANDA076071 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-180_d4065c9f-d681-4d49-af2b-a12985ca3e57 43353-180 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150728 ANDA ANDA078583 Aphena Pharma Solutions - Tennessee, LLC ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-181_008b02ec-523f-4a5b-94aa-3dbaa31962ce 43353-181 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20130919 ANDA ANDA091226 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-182_008b02ec-523f-4a5b-94aa-3dbaa31962ce 43353-182 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20130919 ANDA ANDA091226 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-184_008b02ec-523f-4a5b-94aa-3dbaa31962ce 43353-184 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20130919 ANDA ANDA091226 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-185_209c5683-a531-42ba-bfd6-2ae3a1cc4bc7 43353-185 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20160119 ANDA ANDA091151 Aphena Pharma Solutions - Tennessee, LLC ESZOPICLONE 3 mg/1 CIV N 20181231 43353-186_8b90efb6-87d0-428c-b0ef-13237a009714 43353-186 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 19861024 ANDA ANDA018659 Aphena Pharma Solutions - Tennessee, LLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 43353-189_766d36f6-4d9f-43d6-a24e-7989bf1da93c 43353-189 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20050622 ANDA ANDA075932 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43353-190_9121c600-3006-4a44-baee-c83bee7fcf7f 43353-190 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 20121102 ANDA ANDA202764 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43353-194_f70e20d8-079c-48fa-9dde-acc3025d487e 43353-194 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43353-195_f70e20d8-079c-48fa-9dde-acc3025d487e 43353-195 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43353-196_f70e20d8-079c-48fa-9dde-acc3025d487e 43353-196 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43353-198_f70e20d8-079c-48fa-9dde-acc3025d487e 43353-198 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43353-199_f76944fe-c1e8-4cd6-a7ec-72b0a243c590 43353-199 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Aphena Pharma Solutions - Tennessee, LLC HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 43353-200_209c5683-a531-42ba-bfd6-2ae3a1cc4bc7 43353-200 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20160119 ANDA ANDA091151 Aphena Pharma Solutions - Tennessee, LLC ESZOPICLONE 2 mg/1 CIV N 20181231 43353-201_9d397bfd-f53e-42ca-8e0f-5392b6324e15 43353-201 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120123 ANDA ANDA091305 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-202_ecb7364e-2cdc-43b0-b211-0ba9e6f107a3 43353-202 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20160208 ANDA ANDA090324 Aphena Pharma Solutions - Tennessee, LLC CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 43353-203_5d9f8837-554b-4b8e-ada3-7e705d4806d0 43353-203 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET, FILM COATED ORAL 20140707 ANDA ANDA077492 Aphena Pharma Solutions - Tennessee, LLC VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43353-205_7ff2351c-0271-49c1-b5d4-cb73b76a508c 43353-205 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20160520 ANDA ANDA090255 Aphena Pharma Solutions - Tennessee, LLC HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 43353-207_c6784fa1-f4f6-403b-bab4-2e681cf226eb 43353-207 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Aphena Pharma Solutions - Tennessee, LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43353-208_15b2d425-9b35-4453-b086-2a77d1d5af33 43353-208 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM TABLET ORAL 20121001 ANDA ANDA077534 Aphena Pharma Solutions - Tennessee, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-209_9e0cad11-64f5-41e1-986d-d696d8a6e7ae 43353-209 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20001204 ANDA ANDA075269 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43353-211_68ef14c5-d88d-4c95-b6d4-65606f4c11fa 43353-211 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20160610 ANDA ANDA091305 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-215_781c4c71-059d-40d0-bcd3-0867dcb550f3 43353-215 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 43353-216_68ef14c5-d88d-4c95-b6d4-65606f4c11fa 43353-216 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20160610 ANDA ANDA091305 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-218_68ef14c5-d88d-4c95-b6d4-65606f4c11fa 43353-218 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20160610 ANDA ANDA091305 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-219_7d5d42ee-0533-4ade-9d04-8a58ec77b8f7 43353-219 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20111115 ANDA ANDA040833 Aphena Pharma Solutions - Tennessee, LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 43353-220_91f0fde6-20bc-4bf5-9d44-0491bcced193 43353-220 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43353-221_91f0fde6-20bc-4bf5-9d44-0491bcced193 43353-221 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43353-222_26c902cb-733e-4dcb-9a47-f5044956a503 43353-222 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20160601 ANDA ANDA204074 Aphena Pharma Solutions - Tennessee, LLC DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 43353-223_26c902cb-733e-4dcb-9a47-f5044956a503 43353-223 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20160601 ANDA ANDA204074 Aphena Pharma Solutions - Tennessee, LLC DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 43353-233_c0d29c8f-bd6a-4b5c-adba-7e5ebdd8029c 43353-233 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA200834 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-234_c0d29c8f-bd6a-4b5c-adba-7e5ebdd8029c 43353-234 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111123 ANDA ANDA200834 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-240_e5f8cae3-76be-4f78-9b8a-690bacf28a09 43353-240 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20070301 ANDA ANDA040702 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-242_6c7b0267-beeb-4a99-8a4b-85107ed0bc11 43353-242 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Aphena Pharma Solutions - Tennessee, LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 43353-243_6c7b0267-beeb-4a99-8a4b-85107ed0bc11 43353-243 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Aphena Pharma Solutions - Tennessee, LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 43353-244_d77d1a4a-a796-461e-8f2a-fa85d3349a86 43353-244 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20100701 ANDA ANDA076447 Aphena Pharma Solutions - Tennessee, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 43353-251_1b830c7d-ff8d-45b1-8f56-9206fa600e36 43353-251 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20071102 ANDA ANDA077955 Aphena Pharma Solutions - Tennessee, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43353-253_293b1286-f467-418f-9b40-e5502c14c3b9 43353-253 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20150828 ANDA ANDA204310 Aphena Pharma Solutions - Tennessee, LLC RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 43353-257_e3381eee-5310-4f22-ae15-a059905f2c83 43353-257 HUMAN PRESCRIPTION DRUG Celecoxib celecoxib CAPSULE ORAL 20151109 ANDA ANDA078857 Aphena Pharma Solutions - Tennessee, LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-258_137b8563-7235-4e5b-bcdf-68e788eb8d8b 43353-258 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20160620 ANDA ANDA078881 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43353-259_4e821261-b7dd-4906-a564-1263976a8802 43353-259 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Aphena Pharma Solutions - Tennessee, LLC LORATADINE 10 mg/1 N 20181231 43353-260_2fd771e0-3589-4025-af8d-76037071a223 43353-260 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-263_46aed802-1b67-48f3-bf67-5a1c7a49cc46 43353-263 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 50 mg/1 CV N 20181231 43353-264_46aed802-1b67-48f3-bf67-5a1c7a49cc46 43353-264 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 75 mg/1 CV N 20181231 43353-265_137b8563-7235-4e5b-bcdf-68e788eb8d8b 43353-265 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20160620 ANDA ANDA078881 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43353-266_137b8563-7235-4e5b-bcdf-68e788eb8d8b 43353-266 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20160620 ANDA ANDA078881 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43353-267_137b8563-7235-4e5b-bcdf-68e788eb8d8b 43353-267 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20160620 ANDA ANDA078881 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43353-268_c0d29c8f-bd6a-4b5c-adba-7e5ebdd8029c 43353-268 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA200834 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-269_0cf628ea-f6b0-4e31-8640-d40b7aa64826 43353-269 HUMAN PRESCRIPTION DRUG clopidogrel bisulfate clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076274 Aphena Pharma Solutions - Tennessee, LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 43353-270_60e6a8b2-92bc-4a12-9d15-67fa41d8d3dc 43353-270 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140315 ANDA ANDA203508 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-271_60e6a8b2-92bc-4a12-9d15-67fa41d8d3dc 43353-271 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140315 ANDA ANDA203508 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-272_3e47ea73-8fb6-4624-9dad-de04d8d650de 43353-272 HUMAN PRESCRIPTION DRUG Tricor Fenofibrate TABLET ORAL 20160205 NDA NDA021656 Aphena Pharma Solutions - Tennessee, LLC FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 43353-273_5df716b0-945d-425d-bd24-17123bc77d6d 43353-273 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20140422 ANDA ANDA075682 Aphena Pharma Solutions - Tennessee, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-274_02044cca-72db-4876-8c73-8e623464bef4 43353-274 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20140930 ANDA ANDA070184 Aphena Pharma Solutions - Tennessee, LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 43353-276_adf69c69-e739-4ffc-9bad-0f269f804e8c 43353-276 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071136 Aphena Pharma Solutions - Tennessee, LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-277_12b95e60-10f9-423f-9838-b2f514637f39 43353-277 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-278_d316061b-b83d-4b0f-bc01-fce90149a2fa 43353-278 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071135 Aphena Pharma Solutions - Tennessee, LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-279_1f5efbea-ccd0-4213-9324-769b0077144f 43353-279 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE, LIQUID FILLED ORAL 20160715 ANDA ANDA073484 Aphena Pharma Solutions - Tennessee, LLC VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43353-280_0071d814-58ef-4c1d-864a-8a357437f334 43353-280 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130708 ANDA ANDA091624 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-281_c97dc0e4-979e-4f8f-bf23-cc09993eb660 43353-281 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071134 Aphena Pharma Solutions - Tennessee, LLC DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-282_bb032e52-0562-49b5-8448-9c1eddaa6c0c 43353-282 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20160309 ANDA ANDA078503 Aphena Pharma Solutions - Tennessee, LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 43353-284_bb032e52-0562-49b5-8448-9c1eddaa6c0c 43353-284 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20160309 ANDA ANDA078503 Aphena Pharma Solutions - Tennessee, LLC OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 43353-285_9eda2c93-de21-45ec-a9dc-1329d6d44be7 43353-285 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 Aphena Pharma Solutions - Tennessee, LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 43353-287_3346ab8f-347e-4ced-9434-7859582cf3ab 43353-287 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-288_4f48225d-379a-49f9-b970-309c463a4887 43353-288 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 Aphena Pharma Solutions - Tennessee, LLC BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43353-289_0291bd29-faa4-4aa9-83f6-7cb28c229413 43353-289 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Aphena Pharma Solutions - Tennessee, LLC ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-290_0291bd29-faa4-4aa9-83f6-7cb28c229413 43353-290 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Aphena Pharma Solutions - Tennessee, LLC ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-292_b3048e2b-3ff7-4160-870f-147d792ec36c 43353-292 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 Aphena Pharma Solutions - Tennessee, LLC BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43353-294_f7a2760f-2274-412b-8dc6-111f547e7e03 43353-294 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20170105 ANDA ANDA075419 Aphena Pharma Solutions - Tennessee, LLC ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-296_f867ba88-a009-4f0e-8792-d9e0d416117d 43353-296 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Aphena Pharma Solutions - Tennessee, LLC LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 43353-297_50eb65e3-af02-4008-b713-b11f6f61e254 43353-297 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-298_60e6a8b2-92bc-4a12-9d15-67fa41d8d3dc 43353-298 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140315 ANDA ANDA203508 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-299_ba851086-d209-45ed-8d1e-bbf02f89e650 43353-299 HUMAN PRESCRIPTION DRUG Losartan potassium Tablets, 100 mg losartan potassium TABLET ORAL 20120918 ANDA ANDA201170 Aphena Pharma Solutions - Tennessee, LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43353-301_60e6a8b2-92bc-4a12-9d15-67fa41d8d3dc 43353-301 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140315 ANDA ANDA203508 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-303_061f7a95-4302-49fa-8ecf-9f9a55ef0f31 43353-303 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Aphena Pharma Solutions - Tennessee, LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-305_ffb92b61-2291-4a2c-850c-9e11a2b7037a 43353-305 HUMAN PRESCRIPTION DRUG ULORIC febuxostat TABLET ORAL 20090213 NDA NDA021856 Aphena Pharma Solutions - Tennessee, LLC FEBUXOSTAT 40 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 43353-306_563d9d6a-f2ef-40e3-96e5-7ad90d980027 43353-306 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 Aphena Pharma Solutions - Tennessee, LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 43353-307_6407998d-ebe0-4993-b540-7bdf3fa78075 43353-307 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20131018 ANDA ANDA074869 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-308_6407998d-ebe0-4993-b540-7bdf3fa78075 43353-308 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20131018 ANDA ANDA074869 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-310_ca87b71c-a13f-4675-b686-e8af41f108b4 43353-310 HUMAN PRESCRIPTION DRUG Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20000804 NDA NDA021168 Aphena Pharma Solutions - Tennessee, LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43353-312_2fd771e0-3589-4025-af8d-76037071a223 43353-312 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-314_6e6fdfaa-8e30-4103-991d-fe0916d1eedf 43353-314 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Aphena Pharma Solutions - Tennessee, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-315_cd00a5cc-04b6-49cd-89d0-ae552b415f5d 43353-315 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20050303 ANDA ANDA076943 Aphena Pharma Solutions - Tennessee, LLC TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43353-316_2bf1938a-b415-4fb4-bb25-c3fc89ed1462 43353-316 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070976 Aphena Pharma Solutions - Tennessee, LLC CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 43353-317_815744b6-6096-4a89-8171-cdca95e10631 43353-317 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20151118 ANDA ANDA090596 Aphena Pharma Solutions - Tennessee, LLC TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 43353-321_485be1a7-60f6-475a-9287-810a9a23e421 43353-321 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-322_bb032e52-0562-49b5-8448-9c1eddaa6c0c 43353-322 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20160309 ANDA ANDA078503 Aphena Pharma Solutions - Tennessee, LLC OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 43353-323_741bda18-742a-4192-b37c-41680ca38343 43353-323 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20080515 NDA NDA021400 APHENA PHARMA SOLUTIONS - TENNESSEE, INC. VARDENAFIL HYDROCHLORIDE 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 43353-324_175e43e8-c69d-4ddf-9ae9-ef51dba79a01 43353-324 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040409 Aphena Pharma Solutions - Tennessee, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 43353-325_5fa3f583-8654-4f38-8014-34b792086809 43353-325 HUMAN OTC DRUG Mi-Acid Gas Relief Simethicone TABLET, CHEWABLE ORAL 20110302 OTC MONOGRAPH FINAL part332 Aphena Pharma Solutions - Tennessee, LLC DIMETHICONE 80 mg/1 N 20181231 43353-326_d6ad0b81-6658-4b27-adf1-0115af4c7471 43353-326 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 Aphena Pharma Solutions - Tennessee, LLC PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 43353-327_ec18aa62-1fed-42cc-aa5f-85c737c7911a 43353-327 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 20000426 ANDA ANDA075091 Aphena Pharma Solutions - Tennessee, LLC CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 43353-329_a3797445-680f-449e-8ffd-522445906bdb 43353-329 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Aphena Pharma Solutions - Tennessee, LLC DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 43353-331_a3797445-680f-449e-8ffd-522445906bdb 43353-331 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Aphena Pharma Solutions - Tennessee, LLC DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 43353-332_6398df0f-8c43-4428-b882-3f5efb53ae00 43353-332 HUMAN PRESCRIPTION DRUG ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET ORAL 20170202 ANDA ANDA079170 Aphena Pharma Solutions - Tennessee, LLC ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-336_2ac4ce1f-b725-46a3-a65c-4c77eeface5d 43353-336 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, LLC LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 43353-338_d210a49a-4415-4bb1-b333-8027e459711b 43353-338 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 Aphena Pharma Solutions - Tennessee, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 43353-339_6398df0f-8c43-4428-b882-3f5efb53ae00 43353-339 HUMAN PRESCRIPTION DRUG ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET ORAL 20170202 ANDA ANDA079170 Aphena Pharma Solutions - Tennessee, LLC ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-340_f51ea50d-671d-4901-b5c0-e6135df7e54e 43353-340 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-341_9307939d-4b16-42e8-a5eb-15dcc8295c44 43353-341 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19810827 NDA NDA018487 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43353-342_adc9595c-1b82-45f5-a679-ecf843d8baf2 43353-342 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20130801 ANDA ANDA072708 Aphena Pharma Solutions - Tennessee, LLC MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 43353-343_add29ca5-ecb5-4b8c-b35f-83a58dbd91bb 43353-343 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20160222 ANDA ANDA077056 Aphena Pharma Solutions - Tennessee, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 43353-344_f51ea50d-671d-4901-b5c0-e6135df7e54e 43353-344 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-345_c1c88939-6766-4d48-bf65-c0662f1472e4 43353-345 HUMAN PRESCRIPTION DRUG Sildenafil sildenafil citrate TABLET, FILM COATED ORAL 20120927 NDA AUTHORIZED GENERIC NDA021845 Aphena Pharma Solutions - Tennessee, LLC SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 43353-346_524fb34f-a4ef-46ca-88b2-15c93ae7cc1f 43353-346 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20160721 ANDA ANDA201486 Aphena Pharma Solutions - Tennessee, LLC TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 43353-349_f51ea50d-671d-4901-b5c0-e6135df7e54e 43353-349 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020125 ANDA ANDA075985 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-352_6398df0f-8c43-4428-b882-3f5efb53ae00 43353-352 HUMAN PRESCRIPTION DRUG ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET ORAL 20170202 ANDA ANDA079170 Aphena Pharma Solutions - Tennessee, LLC ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-367_e666a290-143d-4b82-8f54-841db9acabe4 43353-367 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 Aphena Pharma Solutions - Tennessee, LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 43353-368_1242512b-c6e2-466f-a829-aed0a76785da 43353-368 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 Aphena Pharma Solutions - Tennessee, LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 43353-379_2c861c05-b5b5-4ecf-a221-ad274df017e6 43353-379 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 19940510 ANDA ANDA074226 Aphena Pharma Solutions - Tennessee, LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43353-389_d0243c04-2828-4d38-b95e-b23374e52d27 43353-389 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Aphena Pharma Solutions - Tennessee, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-391_d0243c04-2828-4d38-b95e-b23374e52d27 43353-391 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Aphena Pharma Solutions - Tennessee, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-393_d0243c04-2828-4d38-b95e-b23374e52d27 43353-393 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Aphena Pharma Solutions - Tennessee, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-413_46aed802-1b67-48f3-bf67-5a1c7a49cc46 43353-413 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 100 mg/1 CV N 20181231 43353-414_46aed802-1b67-48f3-bf67-5a1c7a49cc46 43353-414 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 150 mg/1 CV N 20181231 43353-422_175e43e8-c69d-4ddf-9ae9-ef51dba79a01 43353-422 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040084 Aphena Pharma Solutions - Tennessee, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 750 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 43353-436_048d999c-3507-43e8-ac09-b9013ac06e38 43353-436 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Aphena Pharma Solutions - Tennessee, LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43353-445_515aa4a3-308a-4d12-915e-5684210081eb 43353-445 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Aphena Pharma Solutions - Tennessee, LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 43353-451_fe714ed3-35c9-4c0c-b64c-d6e1ba0e685f 43353-451 HUMAN PRESCRIPTION DRUG Triazolam triazolam TABLET ORAL 19821115 NDA AUTHORIZED GENERIC NDA017892 Aphena Pharma Solutions - Tennessee, LLC TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-474_c73f3c0c-77c4-4ac3-a233-f987068b94ac 43353-474 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Aphena Pharma Solutions - Tennessee, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-491_6e052f18-f7a6-4e8b-9222-0a12572960b6 43353-491 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-492_6e052f18-f7a6-4e8b-9222-0a12572960b6 43353-492 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-493_6e052f18-f7a6-4e8b-9222-0a12572960b6 43353-493 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-494_6e052f18-f7a6-4e8b-9222-0a12572960b6 43353-494 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-495_f3aa98c4-1227-4097-9c56-b672796d749d 43353-495 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20030701 NDA AUTHORIZED GENERIC NDA007073 Aphena Pharma Solutions - Tennessee, LLC SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 43353-503_d22cfbf2-c9ef-43fc-b930-6716f9cc45eb 43353-503 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Aphena Pharma Solutions - Tennessee, LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 43353-506_8bdbc4d3-bc72-4981-8cc8-92d9b6a0b523 43353-506 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090810 ANDA ANDA075927 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-510_0b579053-078d-424a-ba43-56db5dcb90aa 43353-510 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 Aphena Pharma Solutions - Tennessee, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 43353-535_a8065d90-4130-414c-8b4b-17d5855067b8 43353-535 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aphena Pharma Solutions - Tennessee, LLC MIRTAZAPINE 15 mg/1 N 20181231 43353-536_a8065d90-4130-414c-8b4b-17d5855067b8 43353-536 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aphena Pharma Solutions - Tennessee, LLC MIRTAZAPINE 30 mg/1 N 20181231 43353-538_83ef2126-1308-4f4c-a917-a360c7e9f3f1 43353-538 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43353-544_8065ca49-06d7-4373-81d0-17e4c33a30b5 43353-544 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 Aphena Pharma Solutions - Tennessee, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-546_83ef2126-1308-4f4c-a917-a360c7e9f3f1 43353-546 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43353-547_a83f0491-37ca-4f44-bb12-2c6780831484 43353-547 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090202 ANDA ANDA077567 Aphena Pharma Solutions - Tennessee, LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43353-554_8065ca49-06d7-4373-81d0-17e4c33a30b5 43353-554 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 Aphena Pharma Solutions - Tennessee, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-569_3b96d2e8-c6df-487e-a159-b094dba435cf 43353-569 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole TABLET, DELAYED RELEASE ORAL 20160620 ANDA ANDA205119 Aphena Pharma Solutions - Tennessee, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 43353-575_c9fe3f15-c0b9-47e7-9930-4536b88ffaf9 43353-575 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43353-578_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-578 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-579_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-579 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-580_1d70ed3f-5d35-4983-8502-0f8ef144d462 43353-580 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20170515 ANDA ANDA204713 Aphena Pharma Solutions - Tennnessee, LLC BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 43353-581_b55de664-1cb5-4542-905c-8880ecd58637 43353-581 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 20180719 ANDA ANDA077754 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-583_f3ee686a-e28c-4af6-b06d-e90642ab6442 43353-583 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA076862 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-584_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-584 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-587_b2821ecc-6d75-4ea4-b57c-78ad508fe7e3 43353-587 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 43353-594_ef69e563-7239-4c78-8fb4-3cd641fbff17 43353-594 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20170620 ANDA ANDA086727 Aphena Pharma Solutions - Tennessee, LLC DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 43353-599_c88a9891-341c-436c-a5dc-60cfe656d1ba 43353-599 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970922 ANDA ANDA074587 Aphena Pharma Solutions - Tennessee, LLC VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 43353-600_c88a9891-341c-436c-a5dc-60cfe656d1ba 43353-600 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960325 ANDA ANDA074587 Aphena Pharma Solutions - Tennessee, LLC VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 43353-607_eb043003-31d8-4757-ac93-1bb8960cf7a4 43353-607 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA076008 Aphena Pharma Solutions - Tennessee, LLC BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 43353-609_eb043003-31d8-4757-ac93-1bb8960cf7a4 43353-609 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020321 ANDA ANDA076008 Aphena Pharma Solutions - Tennessee, LLC BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 43353-610_eb043003-31d8-4757-ac93-1bb8960cf7a4 43353-610 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020321 ANDA ANDA076008 Aphena Pharma Solutions - Tennessee, LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 43353-614_a8065d90-4130-414c-8b4b-17d5855067b8 43353-614 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Aphena Pharma Solutions - Tennessee, LLC MIRTAZAPINE 45 mg/1 N 20181231 43353-616_c68dff8e-c8ac-4ed4-8700-a70b920554a8 43353-616 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Aphena Pharma Solutions - Tennessee, LLC SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 43353-617_e3b4f606-6863-49a5-be7c-48d86b85bdaf 43353-617 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Aphena Pharma Solutions - Tennessee, LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 43353-620_e3b4f606-6863-49a5-be7c-48d86b85bdaf 43353-620 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Aphena Pharma Solutions - Tennessee, LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 43353-633_e3436ec4-da38-4e59-a2cf-e573bb00925a 43353-633 HUMAN PRESCRIPTION DRUG Rocaltrol calcitriol CAPSULE, GELATIN COATED ORAL 20090810 NDA NDA018044 Aphena Pharma Solutions - Tennessee, Inc. CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 43353-635_6843ed60-a1a4-4a20-a079-8cc1ee7af7ce 43353-635 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20020917 ANDA ANDA075907 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-637_682046db-6afc-4387-9e0f-24fb0d06d436 43353-637 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20010802 ANDA ANDA075049 Aphena Pharma Solutions - Tennessee, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-643_ef026ab2-cba4-4528-b8b6-1f6f142405ad 43353-643 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-646_30c400c9-6ac0-44c8-ab03-f18c634c23cf 43353-646 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20110720 ANDA ANDA076161 Aphena Pharma Solutions - Tennessee, LLC DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-647_094bc311-4e4d-4a6e-9f7b-6015e38af182 43353-647 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Aphena Pharma Solutions - Tennessee, LLC DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-648_094bc311-4e4d-4a6e-9f7b-6015e38af182 43353-648 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Aphena Pharma Solutions - Tennessee, LLC DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-652_79266f41-f728-4daa-9c57-b2a5f3881e17 43353-652 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072192 Aphena Pharma Solutions - Tennessee, LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 43353-653_79266f41-f728-4daa-9c57-b2a5f3881e17 43353-653 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072193 Aphena Pharma Solutions - Tennessee, LLC TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 43353-656_2a0c2fc7-a26a-4b44-9383-d702cb159a21 43353-656 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 Aphena Pharma Solutions - Tennessee, LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43353-657_d23b71f4-876d-4774-8b8c-3eb0303b2dbd 43353-657 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 Aphena Pharma Solutions - Tennessee, Inc. PREDNISONE 5 mg/1 N 20181231 43353-659_2a0c2fc7-a26a-4b44-9383-d702cb159a21 43353-659 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 Aphena Pharma Solutions - Tennessee, LLC GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43353-662_ef026ab2-cba4-4528-b8b6-1f6f142405ad 43353-662 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-663_f6a44bf9-c610-4be8-a289-2bbbe103b9c8 43353-663 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 Aphena Pharma Solutions - Tennessee, LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-675_46aed802-1b67-48f3-bf67-5a1c7a49cc46 43353-675 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 200 mg/1 CV N 20181231 43353-677_8bdbc4d3-bc72-4981-8cc8-92d9b6a0b523 43353-677 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040401 ANDA ANDA076494 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-681_8e145279-0997-4800-901d-6f96059c681c 43353-681 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100604 ANDA ANDA040756 Aphena Pharma Solutions - Tennessee, LLC FOLIC ACID 1 mg/1 N 20181231 43353-684_1fb58ec3-f97b-443f-ada2-a8d4edaedef8 43353-684 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Aphena Pharma Solutions - Tennessee, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43353-686_2b1eb024-67ec-47d5-a360-b2194ce79f33 43353-686 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 19960216 ANDA ANDA074069 Aphena Pharma Solutions - Tennessee, LLC AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 43353-687_950b1a7a-07f6-4741-9846-0e2f7e798e3e 43353-687 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Aphena Pharma Solutions - Tennessee, Inc. ESTROGENS, CONJUGATED .3 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 43353-688_950b1a7a-07f6-4741-9846-0e2f7e798e3e 43353-688 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Aphena Pharma Solutions - Tennessee, Inc. ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 43353-689_a9d8d871-3b80-47a6-9029-1e9445bcdf77 43353-689 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20100804 ANDA ANDA090027 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-690_a9d8d871-3b80-47a6-9029-1e9445bcdf77 43353-690 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20100804 ANDA ANDA090027 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-691_1fb58ec3-f97b-443f-ada2-a8d4edaedef8 43353-691 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Aphena Pharma Solutions - Tennessee, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43353-693_ddc19c82-dad2-4b79-abda-4730858afea8 43353-693 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Aphena Pharma Solutions - Tennessee, LLC AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 43353-695_20fe0892-ca2f-4934-83c2-c88c9d48189a 43353-695 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20110708 ANDA ANDA079162 Aphena Pharma Solutions - Tennessee, LLC TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43353-696_1166a6cd-e221-43fb-825f-9f1489ec967b 43353-696 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20110708 ANDA ANDA079162 Aphena Pharma Solutions - Tennessee, LLC TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43353-699_e0078bdb-6976-4f1a-b2e8-c9c0fbc8360e 43353-699 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20020926 ANDA ANDA085475 Aphena Pharma Solutions - Tennessee, LLC CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-701_018fea8f-a408-468e-b2c5-c203cd8ef235 43353-701 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070218 Aphena Pharma Solutions - Tennessee, LLC PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-703_e6b96b75-60f4-4c16-ac23-c2d6356ff658 43353-703 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA090408 Aphena Pharma Solutions - Tennessee, LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-706_018fea8f-a408-468e-b2c5-c203cd8ef235 43353-706 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070219 Aphena Pharma Solutions - Tennessee, LLC PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-707_1d70ed3f-5d35-4983-8502-0f8ef144d462 43353-707 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20170515 ANDA ANDA204713 Aphena Pharma Solutions - Tennnessee, LLC BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 43353-709_63578037-37d7-4aff-8c75-da3338940c06 43353-709 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Aphena Pharma Solutions - Tennessee, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43353-710_63578037-37d7-4aff-8c75-da3338940c06 43353-710 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Aphena Pharma Solutions - Tennessee, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43353-711_7d55fc67-1183-48fe-b6f6-a9cbc1df0d25 43353-711 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20121025 ANDA ANDA070920 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-717_80c4cb36-638f-4d42-aa92-c5428ba5c547 43353-717 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19800107 ANDA ANDA083177 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-719_80c4cb36-638f-4d42-aa92-c5428ba5c547 43353-719 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19730112 ANDA ANDA083177 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-721_175e43e8-c69d-4ddf-9ae9-ef51dba79a01 43353-721 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040405 Aphena Pharma Solutions - Tennessee, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 43353-727_8f487e7b-4fbe-4c56-b86f-4cfcda789e09 43353-727 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101206 NDA AUTHORIZED GENERIC NDA021774 Aphena Pharma Solutions - Tennessee, LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 43353-731_63578037-37d7-4aff-8c75-da3338940c06 43353-731 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Aphena Pharma Solutions - Tennessee, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43353-732_d8e9d4e0-1fe8-45df-96ac-b6328eb3301d 43353-732 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070601 ANDA ANDA040702 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-733_d8e9d4e0-1fe8-45df-96ac-b6328eb3301d 43353-733 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070601 ANDA ANDA040702 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-734_d22cfbf2-c9ef-43fc-b930-6716f9cc45eb 43353-734 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Aphena Pharma Solutions - Tennessee, LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 43353-735_0f90e61a-246f-4162-929d-001bec7e31d4 43353-735 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100719 ANDA ANDA077455 Aphena Pharma Solutions - Tennessee, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43353-736_c2c53be9-ea0f-4dc5-a61f-2b6f8904d842 43353-736 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Aphena Pharma Solutions - Tennessee, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 43353-737_3f914177-d57c-4f45-9cf3-4b98f8354ef8 43353-737 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43353-739_30c400c9-6ac0-44c8-ab03-f18c634c23cf 43353-739 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20110720 ANDA ANDA076161 Aphena Pharma Solutions - Tennessee, LLC DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-740_30c400c9-6ac0-44c8-ab03-f18c634c23cf 43353-740 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20110720 ANDA ANDA076161 Aphena Pharma Solutions - Tennessee, LLC DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-741_95bf61f7-6238-4b01-b70e-df731b5f642b 43353-741 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20110422 NDA NDA021400 APHENA PHARMA SOLUTIONS - TENNESSEE, INC. VARDENAFIL HYDROCHLORIDE 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 43353-742_959e4ed8-d633-4f2c-a52d-775c3ef577df 43353-742 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Aphena Pharma Solutions - Tennessee, LLC HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 43353-744_95bf61f7-6238-4b01-b70e-df731b5f642b 43353-744 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20110422 NDA NDA021400 APHENA PHARMA SOLUTIONS - TENNESSEE, INC. VARDENAFIL HYDROCHLORIDE 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 43353-745_2a5598d0-3932-4397-97b3-5d63dc7af1f7 43353-745 HUMAN PRESCRIPTION DRUG Azathioprine azathioprine TABLET ORAL 20091228 ANDA ANDA075568 Aphena Pharma Solutions - Tennessee, LLC AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 43353-746_96bf130d-854d-4e51-834f-95df39f5c858 43353-746 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride alfuzosin TABLET, EXTENDED RELEASE ORAL 20110809 ANDA ANDA079014 Aphena Pharma Solutions - Tennessee, LLC ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-747_0b40530f-d489-4875-a93f-da7c1cff7316 43353-747 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43353-748_95bf61f7-6238-4b01-b70e-df731b5f642b 43353-748 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20110422 NDA NDA021400 APHENA PHARMA SOLUTIONS - TENNESSEE, INC. VARDENAFIL HYDROCHLORIDE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 43353-749_06b4d8bf-ec68-46e6-9922-53a363ebc1dd 43353-749 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980312 ANDA ANDA075074 Aphena Pharma Solutions - Tennessee, LLC ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-750_5d4b75d6-4cf4-461f-9d36-2d6eab6cccc1 43353-750 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120723 ANDA ANDA201071 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43353-752_06b4d8bf-ec68-46e6-9922-53a363ebc1dd 43353-752 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Aphena Pharma Solutions - Tennessee, LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-753_06b4d8bf-ec68-46e6-9922-53a363ebc1dd 43353-753 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980405 ANDA ANDA075078 Aphena Pharma Solutions - Tennessee, LLC ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-754_9139290e-82d1-40ea-afbe-4fd7be934799 43353-754 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Aphena Pharma Solutions - Tennessee, LLC RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-755_9139290e-82d1-40ea-afbe-4fd7be934799 43353-755 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Aphena Pharma Solutions - Tennessee, LLC RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-756_959e4ed8-d633-4f2c-a52d-775c3ef577df 43353-756 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Aphena Pharma Solutions - Tennessee, LLC HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 43353-757_9139290e-82d1-40ea-afbe-4fd7be934799 43353-757 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Aphena Pharma Solutions - Tennessee, LLC RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-760_3b6da186-33ef-4a85-90df-f008a31ab498 43353-760 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine TABLET, FILM COATED ORAL 20140320 ANDA ANDA077081 Aphena Pharma Solutions - Tennessee, LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 43353-763_74ee4693-b945-4dda-9ce5-ea72e4568f34 43353-763 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20020606 ANDA ANDA075991 Aphena Pharma Solutions - Tennessee, LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-764_ef12ceed-7534-472e-a8a8-08cafeada087 43353-764 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Aphena Pharma Solutions - Tennessee, LLC SILDENAFIL CITRATE 25 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 43353-766_9139290e-82d1-40ea-afbe-4fd7be934799 43353-766 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20080917 ANDA ANDA076288 Aphena Pharma Solutions - Tennessee, LLC RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-767_935e87ee-39e2-46b7-94c1-9d3b88057ff7 43353-767 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43353-768_32c9ba10-d55e-4ed1-9ae8-6621580495df 43353-768 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111017 ANDA ANDA078034 Aphena Pharma Solutions - Tennessee, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-769_36b19b28-8577-4be5-bab3-b8f32b9f6a33 43353-769 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 Aphena Pharma Solutions - Tennessee, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 43353-771_c132877c-8560-4c40-aa6a-d53da089ff5a 43353-771 HUMAN PRESCRIPTION DRUG SALSALATE SALSALATE TABLET ORAL 20110522 UNAPPROVED DRUG OTHER Aphena Pharma Solutions - Tennessee, Inc. SALSALATE 750 mg/1 N 20181231 43353-772_23a800db-9bfe-464f-9fc2-5090f2fa6840 43353-772 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20110401 ANDA ANDA078012 Aphena Pharma Solutions - Tennessee, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 43353-773_32c9ba10-d55e-4ed1-9ae8-6621580495df 43353-773 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111017 ANDA ANDA078034 Aphena Pharma Solutions - Tennessee, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-778_638d56f0-1c8f-48b1-9ac6-d18c02726836 43353-778 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110520 ANDA ANDA077045 Aphena Pharma Solutions - Tennessee, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-779_048d999c-3507-43e8-ac09-b9013ac06e38 43353-779 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Aphena Pharma Solutions - Tennessee, LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43353-782_5ef126e4-1e7f-4526-8052-148d3ff10a56 43353-782 HUMAN PRESCRIPTION DRUG Afeditab CR Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021101 ANDA ANDA075659 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43353-783_32c4f44c-dd59-4b03-b271-6e51d20dbf75 43353-783 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Aphena Pharma Solutions - Tennessee, LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-784_fd5924d8-e3f8-4164-81d6-2a5aea0dd202 43353-784 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Aphena Pharma Solutions - Tennessee, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-785_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a 43353-785 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-786_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a 43353-786 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-787_01211049-3b2e-4d9c-a26b-ff2b30bcb118 43353-787 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20120203 ANDA ANDA078626 Aphena Pharma Solutions - Tennessee, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-788_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a 43353-788 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-790_7c37fbd5-1883-41e4-ac9b-cc4b5ca3efd0 43353-790 HUMAN PRESCRIPTION DRUG K-Tab Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19800609 NDA NDA018279 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 43353-792_5ef126e4-1e7f-4526-8052-148d3ff10a56 43353-792 HUMAN PRESCRIPTION DRUG Afeditab CR Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021101 ANDA ANDA075128 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43353-793_e756b759-f051-4dd1-a98f-f93931d3cd6a 43353-793 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-794_fa4f2400-1f0e-402b-a511-b791ad6ab78e 43353-794 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET ORAL 20120229 ANDA ANDA040133 Aphena Pharma Solutions - Tennessee, LLC HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 43353-795_f3ee686a-e28c-4af6-b06d-e90642ab6442 43353-795 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-796_f64c95f3-04d8-4fae-98eb-7c794c449480 43353-796 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040742 Aphena Pharma Solutions - Tennessee, LLC BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 43353-797_37a31bbb-6d44-4d2b-a8ed-32dc6f20a3e2 43353-797 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 43353-798_5050be4b-d47d-4725-9199-caefcc088f11 43353-798 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-799_12b95e60-10f9-423f-9838-b2f514637f39 43353-799 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-800_3e3953cf-b2ac-42a5-a8a4-e33e0e4f29ad 43353-800 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-802_5050be4b-d47d-4725-9199-caefcc088f11 43353-802 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20120507 ANDA ANDA079098 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-808_24332066-8223-4d5c-8957-5c69a287249e 43353-808 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 Aphena Pharma Solutions - Tennessee, LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 43353-809_0693bc9f-ad99-415a-816e-5f3e0e33e682 43353-809 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline TABLET, FILM COATED ORAL 20120820 ANDA ANDA077397 Aphena Pharma Solutions - Tennessee, LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-811_a1f2eedc-8ca8-46a4-b87f-1a976103e933 43353-811 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120626 ANDA ANDA077880 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-812_0693bc9f-ad99-415a-816e-5f3e0e33e682 43353-812 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline TABLET, FILM COATED ORAL 20120820 ANDA ANDA077397 Aphena Pharma Solutions - Tennessee, LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-813_59a4aa04-8122-4125-95ef-b30e33c375ed 43353-813 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090749 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-814_59a4aa04-8122-4125-95ef-b30e33c375ed 43353-814 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-815_6aed3ce5-133c-426e-9efa-f2ef78fcbfbb 43353-815 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-817_0693bc9f-ad99-415a-816e-5f3e0e33e682 43353-817 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline TABLET, FILM COATED ORAL 20120820 ANDA ANDA077397 Aphena Pharma Solutions - Tennessee, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-818_59a4aa04-8122-4125-95ef-b30e33c375ed 43353-818 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-819_71eaa797-a9d9-4eb6-be98-68fc6af213cc 43353-819 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA080356 Aphena Pharma Solutions - Tennessee, LLC PREDNISONE 5 mg/1 N 20181231 43353-820_32c4f44c-dd59-4b03-b271-6e51d20dbf75 43353-820 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Aphena Pharma Solutions - Tennessee, LLC DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-821_6aed3ce5-133c-426e-9efa-f2ef78fcbfbb 43353-821 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-824_6ea4aa04-8d99-4cdb-8d01-8a80ec995b70 43353-824 HUMAN PRESCRIPTION DRUG FOLIC ACID FOLIC ACID TABLET ORAL 20100406 ANDA ANDA090035 Aphena Pharma Solutions - Tennessee, LLC FOLIC ACID 1 mg/1 N 20181231 43353-825_ab1a1c72-dcae-47ba-8f0e-aefb9b5143a0 43353-825 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071307 Aphena Pharma Solutions - Tennessee, LLC DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-826_96063d7d-db68-4e69-8f63-7e6e3ee69a10 43353-826 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-827_96063d7d-db68-4e69-8f63-7e6e3ee69a10 43353-827 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-828_9e948241-a8c1-46e2-98c8-9c10893556b0 43353-828 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20100315 ANDA ANDA040865 Aphena Pharma Solutions - Tennessee, LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 43353-829_401ad0d0-fa30-47a8-9314-9a07a05bbabc 43353-829 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090123 ANDA ANDA075410 Aphena Pharma Solutions - Tennessee, LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43353-830_cba7fa75-7b6b-4add-8a60-7dcb8557d9b5 43353-830 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19930330 ANDA ANDA073475 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-831_adec9b98-1867-41a0-9288-3185c095a6fc 43353-831 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20120810 ANDA ANDA076594 Aphena Pharma Solutions - Tennessee, LLC MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 43353-832_c13aa0de-b0cb-47a8-a932-e093ea2d9526 43353-832 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 43353-833_dac66f7f-c5e7-4781-a1d1-540604e87d76 43353-833 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-834_7eca20ff-75cb-402d-942a-7c4854718687 43353-834 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20140220 ANDA ANDA073457 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-836_5d4b75d6-4cf4-461f-9d36-2d6eab6cccc1 43353-836 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120723 ANDA ANDA201071 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43353-837_c13aa0de-b0cb-47a8-a932-e093ea2d9526 43353-837 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 43353-838_c13aa0de-b0cb-47a8-a932-e093ea2d9526 43353-838 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 43353-839_f0b71958-717d-4b8d-93ef-3f0f5f1d0c60 43353-839 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 19760729 ANDA ANDA080966 Aphena Pharma Solutions - Tennessee, LLC PROBENECID 500 mg/1 N 20181231 43353-840_46aed802-1b67-48f3-bf67-5a1c7a49cc46 43353-840 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 300 mg/1 CV N 20181231 43353-842_a1f2eedc-8ca8-46a4-b87f-1a976103e933 43353-842 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120626 ANDA ANDA077880 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-845_773d481a-a489-492b-a74e-eede0e3987da 43353-845 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Aphena Pharma Solutions - Tennessee, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-847_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a 43353-847 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-848_bd5ca3e8-e294-46b9-94b4-3a66309a40b9 43353-848 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Aphena Pharma Solutions - Tennessee, LLC ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-849_bd5ca3e8-e294-46b9-94b4-3a66309a40b9 43353-849 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Aphena Pharma Solutions - Tennessee, LLC ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-850_bd5ca3e8-e294-46b9-94b4-3a66309a40b9 43353-850 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Aphena Pharma Solutions - Tennessee, LLC ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-852_f8e096c7-a9df-4f0a-8b74-a8d85c8b257a 43353-852 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-854_31cb7052-4226-4ab2-96c2-8a7fe4714d82 43353-854 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20090901 NDA NDA022352 Aphena Pharma Solutions - Tennessee, LLC COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20181231 43353-856_68513fbe-c3f6-42f4-8358-589aad365109 43353-856 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-857_b4838593-912d-4a06-a78c-b28e2942ba83 43353-857 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Aphena Pharma Solutions - Tennessee, LLC TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 43353-858_68513fbe-c3f6-42f4-8358-589aad365109 43353-858 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-860_68513fbe-c3f6-42f4-8358-589aad365109 43353-860 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-861_68513fbe-c3f6-42f4-8358-589aad365109 43353-861 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-862_19801231-00a9-4772-b3b1-9be1ac7c1b86 43353-862 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43353-863_19801231-00a9-4772-b3b1-9be1ac7c1b86 43353-863 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43353-864_19801231-00a9-4772-b3b1-9be1ac7c1b86 43353-864 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43353-865_43634dd1-d97c-4fb3-a9bc-b8576f449655 43353-865 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20130618 ANDA ANDA076262 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-866_43634dd1-d97c-4fb3-a9bc-b8576f449655 43353-866 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20130618 ANDA ANDA076262 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-867_43634dd1-d97c-4fb3-a9bc-b8576f449655 43353-867 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20130618 ANDA ANDA076262 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-868_b1e524e2-cf67-4344-9a06-3e82920af608 43353-868 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20130517 ANDA ANDA072575 Aphena Pharma Solutions - Tennessee, LLC PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-869_f73c56b6-209d-4f7e-97a6-7bc119910fbb 43353-869 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130612 ANDA ANDA090174 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-870_6aaf33c1-90ec-45ad-87fe-603d794a8a0e 43353-870 HUMAN PRESCRIPTION DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL 20050621 ANDA ANDA077222 Aphena Pharma Solutions - Tennessee, LLC FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-872_e9ca1ee7-40fa-4579-87dc-3077b00d9718 43353-872 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 20121102 ANDA ANDA202764 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43353-874_c13aa0de-b0cb-47a8-a932-e093ea2d9526 43353-874 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aphena Pharma Solutions - Tennessee, LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 43353-875_68513fbe-c3f6-42f4-8358-589aad365109 43353-875 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-876_46aed802-1b67-48f3-bf67-5a1c7a49cc46 43353-876 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Aphena Pharma Solutions - Tennessee, LLC PREGABALIN 225 mg/1 CV N 20181231 43353-879_84b17471-807e-4af9-b4ad-a20fe327860f 43353-879 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120810 ANDA ANDA201522 Aphena Pharma Solutions - Tennessee, LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 43353-880_d39e6df1-44b6-46a3-9da7-250f6a589b01 43353-880 HUMAN PRESCRIPTION DRUG Ranexa RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060127 NDA NDA021526 Aphena Pharma Solutions - Tennessee, LLC RANOLAZINE 500 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 43353-881_fb0c5f7c-c8ff-416a-8a21-4e788d401c2f 43353-881 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077517 Aphena Pharma Solutions - Tennessee, LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 43353-882_f73c56b6-209d-4f7e-97a6-7bc119910fbb 43353-882 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130612 ANDA ANDA090174 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-883_5817ec48-bede-499e-ba77-d094e3bdd1ae 43353-883 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Aphena Pharma Solutions - Tennessee, LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 43353-884_08025228-3c71-400b-95ff-80d6aea38f33 43353-884 HUMAN PRESCRIPTION DRUG APRISO mesalamine CAPSULE, EXTENDED RELEASE ORAL 20081031 NDA NDA022301 Aphena Pharma Solutions - Tennessee, LLC MESALAMINE 375 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 43353-885_a1f2eedc-8ca8-46a4-b87f-1a976103e933 43353-885 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20120626 ANDA ANDA077880 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-888_5daab746-e686-48fc-a47d-ba12ec36b88f 43353-888 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Aphena Pharma Solutions - Tennessee, LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 43353-889_5daab746-e686-48fc-a47d-ba12ec36b88f 43353-889 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Aphena Pharma Solutions - Tennessee, LLC DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 43353-890_5e3b0779-f81b-410e-820e-5cd76dad6bf5 43353-890 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20040106 ANDA ANDA076698 Aphena Pharma Solutions - Tennessee, LLC METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 43353-892_96063d7d-db68-4e69-8f63-7e6e3ee69a10 43353-892 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-893_280bbc43-14a1-47e0-a702-8cd8117c2978 43353-893 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20120822 ANDA ANDA077714 Aphena Pharma Solutions - Tennessee, LLC TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 43353-894_d7df9cc9-2bfc-458a-8a60-aecb3ee7ea6f 43353-894 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20140203 ANDA ANDA075965 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-895_2a0c2fc7-a26a-4b44-9383-d702cb159a21 43353-895 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 Aphena Pharma Solutions - Tennessee, LLC GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43353-898_cd1cd9aa-0533-401b-b257-7f3a814c7ff7 43353-898 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20091222 ANDA ANDA076520 Aphena Pharma Solutions - Tennessee, LLC FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 43353-899_45cfd34d-08ac-40a8-95b3-21d3fea687c3 43353-899 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Aphena Pharma Solutions - Tennessee, LLC VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] N 20181231 43353-900_d7fb489a-3230-42da-9d88-236a95d8ad1a 43353-900 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43353-903_5daab746-e686-48fc-a47d-ba12ec36b88f 43353-903 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Aphena Pharma Solutions - Tennessee, LLC DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 43353-904_6aed3ce5-133c-426e-9efa-f2ef78fcbfbb 43353-904 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-906_5daab746-e686-48fc-a47d-ba12ec36b88f 43353-906 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Aphena Pharma Solutions - Tennessee, LLC DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 43353-907_5daab746-e686-48fc-a47d-ba12ec36b88f 43353-907 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Aphena Pharma Solutions - Tennessee, LLC DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 43353-908_744f01da-309f-4cf6-b74e-27648a32a573 43353-908 HUMAN PRESCRIPTION DRUG Precose Acarbose TABLET ORAL 20080130 NDA NDA020482 Aphena Pharma Solutions - Tennessee, LLC ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 43353-911_8992cc1b-9f28-40a5-8c95-06acb3b851b6 43353-911 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43353-912_8992cc1b-9f28-40a5-8c95-06acb3b851b6 43353-912 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43353-913_f64c95f3-04d8-4fae-98eb-7c794c449480 43353-913 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040738 Aphena Pharma Solutions - Tennessee, LLC BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 43353-914_e6afebc0-e70c-4e1b-b40e-0e1868a610ca 43353-914 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20030506 ANDA ANDA076354 Aphena Pharma Solutions - Tennessee, LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 43353-916_2d3ce59f-9be8-43ca-bbf7-06ee7f55d047 43353-916 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Aphena Pharma Solutions - Tennessee, LLC PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 43353-917_30b5ea6e-6e11-4381-affc-45db25bdf092 43353-917 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Aphena Pharma Solutions - Tennessee, LLC ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 43353-918_06b4d8bf-ec68-46e6-9922-53a363ebc1dd 43353-918 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980405 ANDA ANDA075078 Aphena Pharma Solutions - Tennessee, LLC ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-919_959e4ed8-d633-4f2c-a52d-775c3ef577df 43353-919 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Aphena Pharma Solutions - Tennessee, LLC HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 43353-920_8992cc1b-9f28-40a5-8c95-06acb3b851b6 43353-920 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Aphena Pharma Solutions - Tennessee, LLC ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43353-921_31d4ff90-aca0-45e6-ae5e-8e5bacc16970 43353-921 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141204 ANDA ANDA074587 Aphena Pharma Solutions - Tennessee, LLC VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 43353-922_238888fe-9e07-428e-b95e-4fd980ec8f8f 43353-922 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 19810226 ANDA ANDA086831 Aphena Pharma Solutions - Tennessee, LLC CHLORTHALIDONE 50 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 43353-923_41ea6c31-c3a7-411b-aae1-2cf7e9088f67 43353-923 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19860710 ANDA ANDA062677 Aphena Pharma Solutions - Tennessee, LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 43353-924_cbcaf591-b314-4aaa-af60-5da3876e25ac 43353-924 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20090801 ANDA ANDA077859 Aphena Pharma Solutions - Tennessee, LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 43353-925_01f751d9-8907-4a54-b2e9-f57a8f150920 43353-925 HUMAN PRESCRIPTION DRUG modafinil modafinil TABLET ORAL 20120329 NDA AUTHORIZED GENERIC NDA020717 Aphena Pharma Solutions - Tennessee, LLC MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 43353-926_377b3679-29e3-4a57-baf1-9761ea57eefc 43353-926 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Aphena Pharma Solutions - Tennessee, LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-927_6363687c-dcff-451f-8a81-d9f04e79f9ad 43353-927 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 Aphena Pharma Solutions - Tennessee, LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-929_4413cc8b-fe40-438e-9c33-46e699dab2a6 43353-929 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA201071 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43353-931_5e3b0779-f81b-410e-820e-5cd76dad6bf5 43353-931 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20041019 ANDA ANDA076698 Aphena Pharma Solutions - Tennessee, LLC METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 43353-933_32129338-bb18-4c4b-80a2-57ee2631feeb 43353-933 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20120921 ANDA ANDA077309 Aphena Pharma Solutions - Tennessee, LLC ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 43353-936_d7df9cc9-2bfc-458a-8a60-aecb3ee7ea6f 43353-936 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20140203 ANDA ANDA075965 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-942_47c039de-c6d8-40fc-bae3-7a45eb9da57b 43353-942 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-943_47c039de-c6d8-40fc-bae3-7a45eb9da57b 43353-943 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-944_47c039de-c6d8-40fc-bae3-7a45eb9da57b 43353-944 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-945_15c875e9-bc9e-4d06-83f5-0cc5c6742302 43353-945 HUMAN PRESCRIPTION DRUG Alfuzosin hydrochloride Alfuzosin hydrochloride TABLET, EXTENDED RELEASE ORAL 20121002 ANDA ANDA090284 Aphena Pharma Solutions - Tennessee, LLC ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 43353-946_e6afebc0-e70c-4e1b-b40e-0e1868a610ca 43353-946 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20030506 ANDA ANDA076354 Aphena Pharma Solutions - Tennessee, LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 43353-947_de10cd2f-4523-4c70-96f3-9d238c6d74c7 43353-947 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 Aphena Pharma Solutions - Tennessee, LLC AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 43353-948_27924971-951f-4180-8046-541d325e946f 43353-948 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20140220 ANDA ANDA200958 Aphena Pharma Solutions - Tennessee, LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43353-949_9ef4f18d-cf74-4019-b13c-541eb080620e 43353-949 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20140220 ANDA ANDA200958 Aphena Pharma Solutions - Tennessee, LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43353-951_d644a3db-506a-4d45-9cd3-519871c90eb2 43353-951 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20080130 NDA AUTHORIZED GENERIC NDA020482 Aphena Pharma Solutions - Tennessee, LLC ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 43353-952_1d958be7-19f4-4ad9-929c-409a037bda20 43353-952 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20130715 ANDA ANDA200172 Aphena Pharma Solutions - Tennessee, LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 43353-953_7c7b8491-2291-48de-8b76-bf2eca6c9d9c 43353-953 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20140307 ANDA ANDA075948 Aphena Pharma Solutions - Tennessee, LLC CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 43353-954_68984d55-7fc9-4efb-b9e0-7052b3e3a830 43353-954 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Aphena Pharma Solutions - Tennessee, LLC OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-955_ba04e9ec-26d0-4ec3-ba89-9443def0c189 43353-955 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140117 ANDA ANDA077745 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-956_3e90688a-3561-4481-b232-978a4b33a46c 43353-956 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120406 NDA AUTHORIZED GENERIC NDA020717 Aphena Pharma Solutions - Tennessee, LLC MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 43353-957_ba04e9ec-26d0-4ec3-ba89-9443def0c189 43353-957 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140117 ANDA ANDA077745 Aphena Pharma Solutions - Tennessee, LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 43353-958_451f0be0-8e23-4426-a62f-73540f6f2d73 43353-958 HUMAN OTC DRUG Rugby Calcium Carbonate 10 gr Antacid Tablets TABLET, CHEWABLE ORAL 20140207 OTC MONOGRAPH FINAL part331 Aphena Pharma Solutions - Tennessee, LLC CALCIUM CARBONATE 648 mg/1 N 20181231 43353-959_73131824-586d-4048-879b-a4d3b7cbdf30 43353-959 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120529 ANDA ANDA077575 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-960_7431f3dd-bf89-4f5a-a9be-7118b0afbac9 43353-960 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Aphena Pharma Solutions - Tennessee, LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-961_39e1f574-b4d0-461a-9845-16f1ded3854a 43353-961 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 19851119 ANDA ANDA070213 Aphena Pharma Solutions - Tennessee, LLC PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-962_6bf78949-277e-475c-b4ed-76f57bcdcd86 43353-962 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20121228 ANDA ANDA076122 Aphena Pharma Solutions - Tennessee, LLC MIRTAZAPINE 30 mg/1 N 20181231 43353-963_6bf78949-277e-475c-b4ed-76f57bcdcd86 43353-963 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20121228 ANDA ANDA076122 Aphena Pharma Solutions - Tennessee, LLC MIRTAZAPINE 15 mg/1 N 20181231 43353-964_192b80d0-b948-4521-a453-06d66fd29e2f 43353-964 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140617 ANDA ANDA076056 Aphena Pharma Solutions - Tennessee, LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-965_d630cdd9-fe25-4ea6-8a1f-0100bb6e6cb5 43353-965 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 19880419 ANDA ANDA071813 Aphena Pharma Solutions - Tennessee, LLC OXAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-966_192b80d0-b948-4521-a453-06d66fd29e2f 43353-966 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140617 ANDA ANDA077793 Aphena Pharma Solutions - Tennessee, LLC PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-967_b9968b63-c36f-452c-a029-b497534b7d92 43353-967 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20140818 ANDA ANDA077824 Aphena Pharma Solutions - Tennessee, LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 43353-968_b06edb5d-521e-440f-b1a3-97712ec00169 43353-968 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20140721 ANDA ANDA076113 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-969_e0078bdb-6976-4f1a-b2e8-c9c0fbc8360e 43353-969 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20020926 ANDA ANDA085472 Aphena Pharma Solutions - Tennessee, LLC CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-970_1e0a30cf-a624-4b41-aa91-c6fde1419cdf 43353-970 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Aphena Pharma Solutions - Tennessee, LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-971_b9968b63-c36f-452c-a029-b497534b7d92 43353-971 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20140818 ANDA ANDA077824 Aphena Pharma Solutions - Tennessee, LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 43353-972_331bced4-a4ba-48d9-99fa-4a5c479529f2 43353-972 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20140519 ANDA ANDA040766 Aphena Pharma Solutions - Tennessee, LLC HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 43353-973_80bec5c1-751e-453c-b882-3dd39f349ef5 43353-973 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20140206 ANDA ANDA071523 Aphena Pharma Solutions - Tennessee, LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 43353-974_80bec5c1-751e-453c-b882-3dd39f349ef5 43353-974 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20140206 ANDA ANDA071524 Aphena Pharma Solutions - Tennessee, LLC TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 43353-975_45771ade-45bd-48c0-9895-f38ff79766e6 43353-975 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-976_b06edb5d-521e-440f-b1a3-97712ec00169 43353-976 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20140721 ANDA ANDA076113 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-977_b06edb5d-521e-440f-b1a3-97712ec00169 43353-977 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20140721 ANDA ANDA076113 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43353-978_c8f0373d-45aa-49dc-8436-4fc1a9304a57 43353-978 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20111107 ANDA ANDA074625 Aphena Pharma Solutions - Tennessee, LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 43353-979_62545b80-c80e-4b47-af79-ddf178c95191 43353-979 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 Aphena Pharma Solutions - Tennessee, LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43353-980_d630cdd9-fe25-4ea6-8a1f-0100bb6e6cb5 43353-980 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 19880419 ANDA ANDA071814 Aphena Pharma Solutions - Tennessee, LLC OXAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43353-981_73131824-586d-4048-879b-a4d3b7cbdf30 43353-981 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120529 ANDA ANDA077575 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-982_600cc6bc-4c96-40d8-8530-bfaaa5688510 43353-982 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130911 ANDA ANDA203769 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-983_dad379a1-afd2-45d6-9cc1-ab8716bcb906 43353-983 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130708 ANDA ANDA091624 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-984_ee9210aa-aedf-4658-bd12-0710ee2e54b8 43353-984 HUMAN PRESCRIPTION DRUG Galantamine hydrobromide Galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20091215 ANDA ANDA079028 Aphena Pharma Solutions - Tennessee, LLC GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 43353-985_d15ce5c6-2939-4265-a6cc-b6c9686d01c2 43353-985 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone atenolol and chlorthalidone TABLET ORAL 20130328 ANDA ANDA074203 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 43353-986_7eca20ff-75cb-402d-942a-7c4854718687 43353-986 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20140220 ANDA ANDA073457 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43353-987_600cc6bc-4c96-40d8-8530-bfaaa5688510 43353-987 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130911 ANDA ANDA203769 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43353-988_f5549749-851b-4814-88d4-38c9b52bf35c 43353-988 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20140901 ANDA ANDA074726 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 43353-989_0e9a9053-4baf-4549-864b-4a35c92a7e06 43353-989 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20071102 ANDA ANDA077955 Aphena Pharma Solutions - Tennessee, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43353-990_f5549749-851b-4814-88d4-38c9b52bf35c 43353-990 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20140901 ANDA ANDA074726 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 43353-991_9c901276-d5d3-4d22-95f1-043a7e4b067b 43353-991 HUMAN PRESCRIPTION DRUG Probenecid probenecid TABLET, FILM COATED ORAL 19760113 ANDA ANDA084211 Aphena Pharma Solutions - Tennessee, LLC PROBENECID 500 mg/1 N 20181231 43353-992_c5f2cabc-76b1-4a50-b42d-bb938af891cf 43353-992 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA090529 Aphena Pharma Solutions - Tennessee, LLC VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 43353-993_d4004fc6-9440-4480-be75-8baa53b96090 43353-993 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43353-994_75709904-fa17-4f01-9568-53bb3e2f6e80 43353-994 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Aphena Pharma Solutions - Tennessee, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43353-995_ca06eda8-31b3-4f42-a57a-630656336e73 43353-995 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140624 ANDA ANDA075828 Aphena Pharma Solutions - Tennessee, LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43353-996_ff1173d0-d2d0-46a5-8ad7-b59263d5b5f5 43353-996 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120930 NDA NDA020796 Aphena Pharma Solutions - Tennessee, LLC ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 43353-997_7fda39a8-57ef-42fa-8eda-03f88eb0c7ce 43353-997 HUMAN PRESCRIPTION DRUG Plaquenil Hydroxychloroquine Sulfate TABLET ORAL 20130628 NDA NDA009768 Aphena Pharma Solutions - Tennessee, LLC HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 43353-998_9bef390d-c6c4-4961-b030-0da3aa5a106a 43353-998 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20130529 ANDA ANDA091174 Aphena Pharma Solutions - Tennessee, LLC CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 43353-999_484ad518-75e8-4281-a8f2-17d745567d44 43353-999 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 19731127 NDA AUTHORIZED GENERIC NDA017386 Aphena Pharma Solutions - Tennessee, LLC METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 43374-575_bff2fb8b-0a6b-4aee-af5a-c88eabb55422 43374-575 HUMAN OTC DRUG Quik San BENZETHONIUM CHLORIDE LIQUID TOPICAL 20090831 OTC MONOGRAPH NOT FINAL part333 Delta Foremost Chemical Corporation BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 43376-104_5c36c308-b26d-492d-b923-80f600727c8c 43376-104 HUMAN PRESCRIPTION DRUG Sumavel DosePro sumatriptan INJECTION SUBCUTANEOUS 20131204 NDA NDA022239 Zogenix, Inc. SUMATRIPTAN SUCCINATE 4 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 43376-106_5c36c308-b26d-492d-b923-80f600727c8c 43376-106 HUMAN PRESCRIPTION DRUG Sumavel DosePro sumatriptan INJECTION SUBCUTANEOUS 20090715 NDA NDA022239 Zogenix, Inc. SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 43376-210_78f08950-950a-49a4-bd99-3f23befa4d01 43376-210 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 10 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 43376-215_78f08950-950a-49a4-bd99-3f23befa4d01 43376-215 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 15 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 43376-220_78f08950-950a-49a4-bd99-3f23befa4d01 43376-220 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 20 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 43376-230_78f08950-950a-49a4-bd99-3f23befa4d01 43376-230 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 30 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 43376-240_78f08950-950a-49a4-bd99-3f23befa4d01 43376-240 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 40 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 43376-250_78f08950-950a-49a4-bd99-3f23befa4d01 43376-250 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 43376-310_5acca313-4e09-4063-83f3-49ffc4d6fe76 43376-310 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 10 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 43376-315_5acca313-4e09-4063-83f3-49ffc4d6fe76 43376-315 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 15 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 43376-320_5acca313-4e09-4063-83f3-49ffc4d6fe76 43376-320 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 20 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 43376-330_5acca313-4e09-4063-83f3-49ffc4d6fe76 43376-330 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 30 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 43376-340_5acca313-4e09-4063-83f3-49ffc4d6fe76 43376-340 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 40 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 43376-350_5acca313-4e09-4063-83f3-49ffc4d6fe76 43376-350 HUMAN PRESCRIPTION DRUG Zohydro hydrocodone bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Zogenix, Inc. HYDROCODONE BITARTRATE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 43378-104_332c8ac7-01ed-4ec5-abb9-bdb98eefd043 43378-104 HUMAN OTC DRUG Zodryl AC 50 Chlorpheniramine Maleate and Codeine Phosphate SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 2; 5 mg/5mL; mg/5mL CV E 20171231 43378-105_80883522-1b50-4ba4-8375-787feaa941cb 43378-105 HUMAN OTC DRUG Zodryl AC 60 Chlorpheniramine Maleate and Codeine Phosphate SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 1.995; 7.5 mg/7.5mL; mg/7.5mL CV E 20171231 43378-106_1600c314-ebc0-4ac3-9d8b-bc4d5073857b 43378-106 HUMAN OTC DRUG Zodryl AC 80 Chlorpheniramine Maleate and Codeine Phosphate SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 2; 10 mg/10mL; mg/10mL CV E 20171231 43378-120_fa37ced4-619b-4514-9d32-ae50a6572427 43378-120 HUMAN OTC DRUG Zodryl DEC 25 codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; GUAIFENESIN 15; 3; 60 mg/3mL; mg/3mL; mg/3mL CV E 20171231 43378-121_e81702b3-1466-41fc-862b-f387a1fe39e5 43378-121 HUMAN OTC DRUG Zodryl DEC 30 codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; GUAIFENESIN 15.001; 3.5; 70 mg/3.5mL; mg/3.5mL; mg/3.5mL CV E 20171231 43378-123_b51a9a1b-ddbe-47fc-bd22-d9e078dccb9b 43378-123 HUMAN OTC DRUG Zodryl DEC 40 codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; GUAIFENESIN 14.998; 4.5; 90 mg/4.5mL; mg/4.5mL; mg/4.5mL CV E 20171231 43378-124_5ace705f-df68-4517-b65a-06c468111906 43378-124 HUMAN OTC DRUG Zodryl DEC 50 codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; GUAIFENESIN 30; 5; 100 mg/5mL; mg/5mL; mg/5mL CV E 20171231 43378-125_980d54c0-8941-4180-8952-9ae39c5130b3 43378-125 HUMAN OTC DRUG Zodryl DEC 60 codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; GUAIFENESIN 30; 7.5; 150 mg/7.5mL; mg/7.5mL; mg/7.5mL CV E 20171231 43378-126_5e3f17d1-bcb6-4d05-bdd7-59012af8cf4b 43378-126 HUMAN OTC DRUG Zodryl DEC 80 codeine phosphate, guaifenesin and pseudoephedrine hydrochloride SUSPENSION ORAL 20090824 OTC MONOGRAPH FINAL part341 CodaDose, Inc. PSEUDOEPHEDRINE; CODEINE PHOSPHATE; GUAIFENESIN 30; 10; 200 mg/10mL; mg/10mL; mg/10mL CV E 20171231 43386-028_bd7c8e56-cd90-47bc-bd02-d14c1ca6170a 43386-028 HUMAN PRESCRIPTION DRUG clobetasol propionate clobetasol propionate SOLUTION TOPICAL 20151123 ANDA ANDA206075 Lupin Pharmaceuticals,Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43386-038_e582cbb6-99d4-4583-8567-4ded7e9cf39a 43386-038 HUMAN PRESCRIPTION DRUG VORICONAZOLE voriconazole POWDER, FOR SUSPENSION ORAL 20160601 ANDA ANDA206799 Lupin Pharmaceuticals,Inc. VORICONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 43386-050_3ff4d772-6527-4791-9236-e1a97878a200 43386-050 HUMAN PRESCRIPTION DRUG GaviLyte - N polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate POWDER, FOR SOLUTION ORAL 20090528 ANDA ANDA090019 Lupin Pharmaceuticals,Inc. POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE 420; 11.2; 5.72; 1.48 g/438.4g; g/438.4g; g/438.4g; g/438.4g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 43386-060_7af81acb-3c86-4089-93dc-2cf9a6fac42a 43386-060 HUMAN PRESCRIPTION DRUG GaviLyte - C TM polyethylene glycol-3350 and electrolytes with Flavor Pack POWDER, FOR SOLUTION ORAL 20090106 ANDA ANDA090186 Lupin Pharmaceuticals,Inc. POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM SULFATE ANHYDROUS 240; 5.84; 2.98; 6.72; 22.72 g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 43386-069_8e3b6a94-4145-4181-9777-22e6efd102ea 43386-069 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide SOLUTION TOPICAL 20150902 ANDA ANDA206422 Lupin Pharmaceuticals,Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43386-071_78f1f6cb-09bd-4c5c-ba86-bfbd66e9576b 43386-071 HUMAN PRESCRIPTION DRUG GaviLyte-H and Bisacodyl Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl Delayed-release Tablet KIT ORAL 20150421 ANDA ANDA202217 GAVIS Pharmaceuticals, LLC N 20181231 43386-080_bdf7450f-3512-4635-8180-8bcdd09edc16 43386-080 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA202829 Gavis Pharmaceuticals, LLC AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 43386-081_bdf7450f-3512-4635-8180-8bcdd09edc16 43386-081 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA202829 Gavis Pharmaceuticals, LLC AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 43386-082_bdf7450f-3512-4635-8180-8bcdd09edc16 43386-082 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA202829 Gavis Pharmaceuticals, LLC AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 43386-083_bdf7450f-3512-4635-8180-8bcdd09edc16 43386-083 HUMAN PRESCRIPTION DRUG AMLODIPINE and VALSARTAN AMLODIPINE and VALSARTAN TABLET ORAL 20150330 ANDA ANDA202829 Gavis Pharmaceuticals, LLC AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43386-088_136d4e30-abf0-4611-b220-92e838b52f16 43386-088 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20160524 ANDA ANDA207371 Lupin Pharmaceuticals,Inc. VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 43386-089_136d4e30-abf0-4611-b220-92e838b52f16 43386-089 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20160524 ANDA ANDA207371 Lupin Pharmaceuticals,Inc. VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 43386-090_22a9a510-9fef-45af-a7f6-d77afa6cbfe4 43386-090 HUMAN PRESCRIPTION DRUG GaviLyte G TM polyethylene glycol-3350 and Electrolytes POWDER, FOR SOLUTION ORAL 20090601 ANDA ANDA090231 Lupin Pharmaceuticals,Inc. POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 236; 22.74; 6.74; 5.86; 2.97 g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 43386-090_f252aead-84d7-4cb3-b968-a1bb351845ec 43386-090 HUMAN PRESCRIPTION DRUG GaviLyte G TM Polyethylene Glycol-3350 and Electrolytes POWDER, FOR SOLUTION ORAL 20090601 ANDA ANDA090231 GAVIS Pharmaceuticals, LLC POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236; 5.86; 6.74; 2.97; 22.74 g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 43386-118_a99e4bd7-3636-4220-83b8-fba9f30004ca 43386-118 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide TABLET ORAL 20140923 ANDA ANDA091528 Lupin Pharmaceuticals,Inc. HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 43386-140_16ee131d-1b49-4b13-9e23-e915401e7093 43386-140 HUMAN PRESCRIPTION DRUG Methylergonovine Maleate Methylergonovine Maleate TABLET ORAL 20110615 ANDA ANDA091577 Lupin Pharmaceuticals,Inc. METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 43386-160_dc81fbae-4b08-40b3-b5d6-adebec535a56 43386-160 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 Lupin Pharmaceuticals,Inc. MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 43386-161_dc81fbae-4b08-40b3-b5d6-adebec535a56 43386-161 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 Lupin Pharmaceuticals,Inc. MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 43386-312_134d1f7c-7268-4792-9203-887bf424fb0c 43386-312 HUMAN OTC DRUG GAVILAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091009 ANDA ANDA091077 Lupin Pharmaceuticals,Inc. POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 43386-330_cf7a8065-0342-49e4-beb8-8f29b67ac2c8 43386-330 HUMAN PRESCRIPTION DRUG Trimethoprim Trimethoprim TABLET ORAL 20110624 ANDA ANDA091437 Lupin Pharmaceuticals,Inc. TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 43386-351_071f24e3-2d47-45dd-b4ab-b0c431c86b57 43386-351 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161114 ANDA ANDA206142 Lupin Pharmaceuticals,Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 43386-352_071f24e3-2d47-45dd-b4ab-b0c431c86b57 43386-352 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161114 ANDA ANDA206142 Lupin Pharmaceuticals,Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 43386-353_071f24e3-2d47-45dd-b4ab-b0c431c86b57 43386-353 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161114 ANDA ANDA206142 Lupin Pharmaceuticals,Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 43386-356_f5c35284-df79-49ba-a06b-29af0afd7f12 43386-356 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161201 ANDA ANDA206245 Lupin Pharmaceuticals,Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 43386-357_f5c35284-df79-49ba-a06b-29af0afd7f12 43386-357 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161201 ANDA ANDA206245 Lupin Pharmaceuticals,Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 43386-358_f5c35284-df79-49ba-a06b-29af0afd7f12 43386-358 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161201 ANDA ANDA206245 Lupin Pharmaceuticals,Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 43386-360_1eb0b695-ce65-45c2-914a-87bc2105b139 43386-360 HUMAN PRESCRIPTION DRUG Phenelzine Sulfate Phenelzine Sulfate TABLET ORAL 20101214 ANDA ANDA200181 Lupin Pharmaceuticals,Inc. PHENELZINE SULFATE 15 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 43386-440_2be1748e-7281-43e8-b109-95c16c69985c 43386-440 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20090811 ANDA ANDA072781 GAVIS Pharmaceuticals, LLC NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 43386-450_1f547df0-9394-4f76-9a8e-9815e0631278 43386-450 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin SUSPENSION ORAL 20150521 ANDA ANDA201693 Lupin Pharmaceuticals,Inc. NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 43386-470_29ca4bfb-67cc-4531-8d9c-598a03e60fcc 43386-470 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin FOR SUSPENSION ORAL 20170927 ANDA ANDA065488 Lupin Pharmaceuticals,Inc. AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 43386-471_29ca4bfb-67cc-4531-8d9c-598a03e60fcc 43386-471 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin FOR SUSPENSION ORAL 20170927 ANDA ANDA065488 Lupin Pharmaceuticals,Inc. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 43386-480_4d8d236d-bd7c-43b3-a8a1-dc984b081851 43386-480 HUMAN PRESCRIPTION DRUG ORPHENADRINE CITRATE ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Lupin Pharmaceuticals, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43386-500_82462011-668a-4fbd-9653-48049901eacc 43386-500 HUMAN PRESCRIPTION DRUG Famotidine Famotidine FOR SUSPENSION ORAL 20121217 ANDA ANDA201695 Lupin Pharmaceuticals,Inc. FAMOTIDINE 40 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 43386-510_cd11492c-78f9-465b-a304-a4cad3bd5edd 43386-510 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine ENEMA RECTAL 20091216 ANDA ANDA019618 GAVIS Pharmaceuticals, LLC MESALAMINE 4 g/60mL Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 43386-530_cfbaa4af-a8b0-4233-b225-2eb8c2a793cd 43386-530 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20140926 ANDA ANDA065138 Lupin Pharmaceuticals,Inc. NYSTATIN 100000 U/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 43386-540_3251b7fd-e1c2-45af-b74b-3eecf3495557 43386-540 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151216 ANDA ANDA203602 Lupin Pharmaceuticals,Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43386-541_3251b7fd-e1c2-45af-b74b-3eecf3495557 43386-541 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151216 ANDA ANDA203602 Lupin Pharmaceuticals,Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43386-542_3251b7fd-e1c2-45af-b74b-3eecf3495557 43386-542 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151216 ANDA ANDA203602 Lupin Pharmaceuticals,Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43386-543_3251b7fd-e1c2-45af-b74b-3eecf3495557 43386-543 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151216 ANDA ANDA203602 Lupin Pharmaceuticals,Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43386-544_3251b7fd-e1c2-45af-b74b-3eecf3495557 43386-544 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151216 ANDA ANDA203602 Lupin Pharmaceuticals,Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43386-550_779bb927-73bc-4e80-b1fd-66bd150615d2 43386-550 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20120430 ANDA ANDA202044 Lupin Pharmaceuticals,Inc. TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 43386-551_779bb927-73bc-4e80-b1fd-66bd150615d2 43386-551 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20120430 ANDA ANDA202044 Lupin Pharmaceuticals,Inc. TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 43386-570_609a7e4c-7192-4b26-b3f3-fc25e90979cc 43386-570 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, CHEWABLE ORAL 20150406 ANDA ANDA204115 Lupin Pharmaceuticals,Inc. METHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-571_609a7e4c-7192-4b26-b3f3-fc25e90979cc 43386-571 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, CHEWABLE ORAL 20150406 ANDA ANDA204115 Lupin Pharmaceuticals,Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-572_609a7e4c-7192-4b26-b3f3-fc25e90979cc 43386-572 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, CHEWABLE ORAL 20150406 ANDA ANDA204115 Lupin Pharmaceuticals,Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-573_be22d03d-7c1d-4a78-9c19-bb3e59f8b55b 43386-573 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20160120 ANDA ANDA207884 Lupin Pharmaceuticals,Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-574_be22d03d-7c1d-4a78-9c19-bb3e59f8b55b 43386-574 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20151113 ANDA ANDA207884 Lupin Pharmaceuticals,Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-575_be22d03d-7c1d-4a78-9c19-bb3e59f8b55b 43386-575 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20151113 ANDA ANDA207884 Lupin Pharmaceuticals,Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-580_01d61ff8-96a6-4940-9bad-22cc0d7b5119 43386-580 HUMAN PRESCRIPTION DRUG METOCLOPRAMIDE hydrochloride Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20150406 ANDA ANDA202191 GAVIS Pharmaceuticals, LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 43386-580_c86c1845-5fec-4fc9-9608-60db9274b98e 43386-580 HUMAN PRESCRIPTION DRUG METOCLOPRAMIDE hydrochloride Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20150406 ANDA ANDA202191 Lupin Pharmaceuticals,Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 43386-581_01d61ff8-96a6-4940-9bad-22cc0d7b5119 43386-581 HUMAN PRESCRIPTION DRUG METOCLOPRAMIDE hydrochloride Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20150406 ANDA ANDA202191 GAVIS Pharmaceuticals, LLC METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 43386-581_c86c1845-5fec-4fc9-9608-60db9274b98e 43386-581 HUMAN PRESCRIPTION DRUG METOCLOPRAMIDE hydrochloride Metoclopramide Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20150406 ANDA ANDA202191 Lupin Pharmaceuticals,Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 43386-620_07b96626-aa19-4ce3-8ef5-c2cbebdb05f6 43386-620 HUMAN PRESCRIPTION DRUG My Way Levonorgestrel TABLET ORAL 20130222 ANDA ANDA202508 GAVIS Pharmaceuticals, LLC. LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] E 20171231 43386-622_6dce7821-019c-4344-9634-5a51060920d5 43386-622 HUMAN OTC DRUG My Way Levonorgestrel TABLET ORAL 20130215 ANDA ANDA202508 Lupin Pharmaceuticals,Inc. LEVONORGESTREL 1.5 mg/1 E 20171231 43386-660_cac4f332-bed3-4bd0-953c-bfa17fe787bf 43386-660 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20110715 ANDA ANDA076546 Lupin Pharmaceuticals,Inc. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 43386-670_fc01cb97-4b1c-4f4f-baed-401357b05489 43386-670 HUMAN PRESCRIPTION DRUG Pentazocine Hydrochloride and Acetaminophen Pentazocine Hydrochloride and Acetaminophen TABLET ORAL 20110511 ANDA ANDA076202 GAVIS Pharmaceuticals, LLC PENTAZOCINE HYDROCHLORIDE; ACETAMINOPHEN 25; 650 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV E 20171231 43386-680_3ed283e0-f73e-4fd3-bac7-60904a2e1db0 43386-680 HUMAN PRESCRIPTION DRUG PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE pentazocine hydrochloride and naloxone hydrochloride TABLET ORAL 20110511 ANDA ANDA075735 Lupin Pharmaceuticals,Inc. PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 50; .5 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV N 20181231 43386-710_7a142355-ef5d-463b-9890-601c59175418 43386-710 HUMAN PRESCRIPTION DRUG Quinapril HCL and Hydrochlorothiazide Quinapril HCl and Hydrochlorothiazide TABLET ORAL 20110715 ANDA ANDA076374 Lupin Pharmaceuticals,Inc. QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43386-711_7a142355-ef5d-463b-9890-601c59175418 43386-711 HUMAN PRESCRIPTION DRUG Quinapril HCL and Hydrochlorothiazide Quinapril HCL and Hydrochlorothiazide TABLET ORAL 20110715 ANDA ANDA076374 Lupin Pharmaceuticals,Inc. QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43386-712_7a142355-ef5d-463b-9890-601c59175418 43386-712 HUMAN PRESCRIPTION DRUG Quinapril HCL and Hydrochlorothiazide Quinapril HCL and Hydrochlorothiazide TABLET ORAL 20110715 ANDA ANDA076374 Lupin Pharmaceuticals,Inc. QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43386-761_82e9f9ed-946a-49e0-be00-a74a0b0b8de2 43386-761 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET SUBLINGUAL 20160322 ANDA ANDA204299 Lupin Pharmaceuticals,Inc. ZOLPIDEM TARTRATE 3.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 43386-762_82e9f9ed-946a-49e0-be00-a74a0b0b8de2 43386-762 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET SUBLINGUAL 20160322 ANDA ANDA204299 Lupin Pharmaceuticals,Inc. ZOLPIDEM TARTRATE 1.75 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 43386-770_52e4558b-e22f-4f13-a692-2f4e12f7ebba 43386-770 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20170707 ANDA ANDA204652 Lupin Pharmaceuticals,Inc. FLUCYTOSINE 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20181231 43386-771_52e4558b-e22f-4f13-a692-2f4e12f7ebba 43386-771 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20170707 ANDA ANDA204652 Lupin Pharmaceuticals,Inc. FLUCYTOSINE 250 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20181231 43386-790_59e1ae71-a28d-4eeb-8c41-96d7f4cd729d 43386-790 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20150708 ANDA ANDA204446 GAVIS Pharmaceuticals, LLC DOXYCYCLINE 50 mg/1 E 20171231 43386-791_59e1ae71-a28d-4eeb-8c41-96d7f4cd729d 43386-791 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20150708 ANDA ANDA204446 GAVIS Pharmaceuticals, LLC DOXYCYCLINE 75 mg/1 E 20171231 43386-792_59e1ae71-a28d-4eeb-8c41-96d7f4cd729d 43386-792 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20150708 ANDA ANDA204446 GAVIS Pharmaceuticals, LLC DOXYCYCLINE 100 mg/1 E 20171231 43386-794_26df3304-2abf-4e47-b982-0ebb46ca0d0b 43386-794 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20170906 ANDA ANDA207558 Lupin Pharmaceuticals,Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 43386-860_6f1518ac-e7d3-4663-9a64-a134b5570a25 43386-860 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20151204 ANDA ANDA204534 Lupin Pharmaceuticals,Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-861_6f1518ac-e7d3-4663-9a64-a134b5570a25 43386-861 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20151204 ANDA ANDA204534 Lupin Pharmaceuticals,Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-862_6f1518ac-e7d3-4663-9a64-a134b5570a25 43386-862 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20151204 ANDA ANDA204534 Lupin Pharmaceuticals,Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-870_f651f775-5bed-432c-a031-bbb42a2f5387 43386-870 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate dextroamphetamine sulfate TABLET ORAL 20160425 ANDA ANDA204330 Lupin Pharmaceuticals,Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-871_f651f775-5bed-432c-a031-bbb42a2f5387 43386-871 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate dextroamphetamine sulfate TABLET ORAL 20160425 ANDA ANDA204330 Lupin Pharmaceuticals,Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-915_a42d6708-dda7-479f-b687-de23f4310dfa 43386-915 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20160121 ANDA ANDA206347 Lupin Pharmaceuticals,Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 43386-917_a42d6708-dda7-479f-b687-de23f4310dfa 43386-917 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20160121 ANDA ANDA206347 Lupin Pharmaceuticals,Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 43386-920_046b482b-5a1a-4c64-acfe-50b58b0868c4 43386-920 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20150701 ANDA ANDA204603 Lupin Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 20 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 43386-930_06b6e9cf-a3fa-4ce7-b781-10d15bc071b0 43386-930 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20151215 ANDA ANDA204602 Lupin Pharmaceuticals,Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-931_06b6e9cf-a3fa-4ce7-b781-10d15bc071b0 43386-931 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20151215 ANDA ANDA204602 Lupin Pharmaceuticals,Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 43386-980_7b3079e3-d9db-41aa-886f-a9f95a828437 43386-980 HUMAN PRESCRIPTION DRUG Carbidopa Carbidopa TABLET ORAL 20171020 ANDA ANDA204763 Lupin Pharmaceuticals,Inc. CARBIDOPA 25 mg/1 N 20181231 43393-203_1a89fe3a-2524-4009-b71f-9f50920a914b 43393-203 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20130102 ANDA ANDA091667 GenBioPro Inc MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 43405-007_c93b44e7-fb28-4df6-af78-924d05a60192 43405-007 HUMAN OTC DRUG Muscular Balm Capsaicin Menthol Methyl Salicylate OINTMENT TOPICAL 20100514 OTC MONOGRAPH NOT FINAL part348 Borden Company (Private) Limited CAPSAICIN; MENTHOL; METHYL SALICYLATE .15; 13.5; 30 g/100g; g/100g; g/100g N 20181231 43405-008_ce1244b7-81e6-4d02-9826-6be56e6f90a9 43405-008 HUMAN OTC DRUG Eagle Medicated Menthol Methyl Salicylate OIL TOPICAL 20120514 OTC MONOGRAPH NOT FINAL part348 Borden Company (Private) Limited MENTHOL; METHYL SALICYLATE 14.5; 30 g/100mL; g/100mL N 20181231 43405-009_5b5650e5-c2ce-48ef-a3d6-dce8f04a926f 43405-009 HUMAN OTC DRUG Eagle Medicated Aromatic Camphor Menthol Methyl Salicylate OIL TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part348 Borden Company (Private) Limited CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 7; 16; 35 g/100mL; g/100mL; g/100mL N 20181231 43405-010_73279db1-a71c-4c5a-8ae9-575325f9a236 43405-010 HUMAN OTC DRUG Eagle Extra Strength Menthol Methyl Salicylate LIQUID TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part348 Borden Company (Private) Limited MENTHOL; METHYL SALICYLATE 14.5; 30 g/100mL; g/100mL N 20181231 43405-882_39a6bfd1-057e-743a-e054-00144ff88e88 43405-882 HUMAN OTC DRUG Eagle Menthol Capsaicin PATCH TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part348 Borden Company PTE Limited CAPSAICIN; MENTHOL .0625; 3.4 g/1; g/1 N 20181231 43406-0001_58e20901-6aa4-40f7-bf75-39e4f569ac90 43406-0001 HUMAN OTC DRUG ACNE HP Carbo Animalis, Activated Charcoal, Potassium Dichromate, Sodium Chloride, Pulsatilla Vulgaris, Sepia Officinalis Juice, Silicon Dioxide, Sulfur, Zinc LIQUID ORAL 20160101 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. CARBO ANIMALIS; ACTIVATED CHARCOAL; POTASSIUM DICHROMATE; SODIUM CHLORIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43406-0002_e4650110-a3f1-47e7-a571-4a5d55cc75e4 43406-0002 HUMAN OTC DRUG Allergy HP Onion, Ambrosia Artemisiifolia, Arsenic Trioxide, Activated Charcoal, Euphrasia Stricta, Strychnos Nux-Vomica Seed, Pulsatilla Vulgaris, Solidago Virgaurea Flowering Top, Sulfur LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0003_f5197199-e91f-4a35-94b3-a2adfd2796b0 43406-0003 HUMAN OTC DRUG Anxiety HP Arsenic Trioxide, Calcium Carbonate, Strychnos Ignatii Seed, Potassium Carbonate, Lachesis Muta Venom, Sodium Chloride, Phosphorus, Pulsatilla LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; CALCIUM CARBONATE; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0004_3fddabd3-cf6d-4201-b346-946ad4c0aacc 43406-0004 HUMAN OTC DRUG Anxiety II HP Aconitum Napellus 30C, Arsenic Trioxide 30C, Belladonna Leaf 30C, Calcium Carbonate 30C, Human Breast Tumor Cell 30C, Causticum 30C, Gelsemium Sempervirens Root 30C, Lachesis Muta Venom 30C, Mercury 30C, Sodium Chloride 30C, Nitric Acid 30C, Phosphorus 30C, Posion Oak Extract 30C LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BELLADONNA LEAF; CALCIUM CARBONATE; HUMAN BREAST TUMOR CELL; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; MERCURY; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0005_73b8ff54-c486-48e4-92b2-d70e5f790f89 43406-0005 HUMAN OTC DRUG Arthritis HP Apis Mellifera, Bryonia Alba Root, Causticum, Colchicum Autumnale Bulb, Kalmia Latifolia Leaf, Ledum Palustre Twig, Pulsatilla Vulgaris, Rhododenron Aureum LEaf, Toxicodendren Pubescens Leaf LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. APIS MELLIFERA; BRYONIA ALBA ROOT; CAUSTICUM; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0006_eb0f9c1b-a3a2-4fae-9093-2c8be348b1a1 43406-0006 HUMAN OTC DRUG Wheezing HP Arsenic Trioxide, Belladonna Leaf, Ipecac, Potassium Carbonate, Lobelia Inflata, Sodium Sulfate, Silicon Dioxide LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; BELLADONNA LEAF; IPECAC; POTASSIUM CARBONATE; LOBELIA INFLATA; SODIUM SULFATE; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0009_92914a42-75a8-4871-bdbf-2b849b76bcb6 43406-0009 HUMAN OTC DRUG BONE REPAIR HP Sodium Borate, Calcium Carbonate, Calcium Fluoride, Tribasic Calcium Phosphate, Eupatorium Perfoliatum Flowering Top, Iron, Hekla Lava, Hydrofluoric Acid, Toxicodendron Pubescens Leaf, Ruta Graveolens Flowering Top, Silicon Dioxide, Comfrey Leaf LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. SODIUM BORATE; CALCIUM CARBONATE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; EUPATORIUM PERFOLIATUM FLOWERING TOP; IRON; HEKLA LAVA; HYDROFLUORIC ACID; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; COMFREY LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0010_bd1dabe2-4df5-4473-8364-ab6f89115e86 43406-0010 HUMAN OTC DRUG Bronchi HP Activated Charcoal, Copper, Drosera Rotundifolia, Ipecac, Lachesis Muta Venom, Lobelia Inflata, Phosphorus, Pulsatilla Vulgaris, Rumex Crispus Root, Spongia Officinalis Skeleton, Roasted LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACTIVATED CHARCOAL; COPPER; DROSERA ROTUNDIFOLIA; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0011_44f82d12-c64b-4df9-889b-dc87f5883baf 43406-0011 HUMAN OTC DRUG Candida HP Echinacea Purpurea, Baptisia Tinctoria Root, Glycyrrhiza Glabra, Astragalus Nuttallii Leaf, Sodium Borate, Oyster Shell Calcium Carbonate, Crude, Wood Creosote, Lycopodium Clavatum Spore, Sodium Phosphate, Dibasic Heptahydrate, Nitric Acid, Strychnos Nux-Vomica Seed, Phosphoric Acid, Pulsatilla Vulgaris, Sepia Officinalis Juice, Candida Albicans LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ECHINACEA PURPUREA; BAPTISIA TINCTORIA ROOT; GLYCYRRHIZA GLABRA; ASTRAGALUS NUTTALLII LEAF; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; CANDIDA ALBICANS; CANDIDA ALBICANS; CANDIDA ALBICANS 1; 3; 3; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 10; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0012_ff3fae0b-24f4-4f3c-ba85-10eca0cdbc88 43406-0012 HUMAN OTC DRUG Cholesterol HP Baptisia Tinctoria Root, Silybum Marianum Seed, Chelidonium Majus, Iodine, Lachesis Muta Venom, Veronicastrum Virginicum Root, Sodium Chloride, Strychnos Nux-Vomica See, Phosphoric Acid LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BAPTISIA TINCTORIA ROOT; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; IODINE; LACHESIS MUTA VENOM; VERONICASTRUM VIRGINICUM ROOT; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0013_f77db443-03c0-4046-8059-c0d4c74357e8 43406-0013 HUMAN OTC DRUG Cold Sore HP Juglan Cinerea Branch Bark/Root Bark, Potassium Iodide, Lycopodium Clavatum Spore, Mercury, Sodium Chloride, Nitric Acid, Phosphorus, Ranunculus Bulbosus, Toxicodendron Pubescens Leaf, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; MERCURY; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORUS; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0014_d550ecd4-1419-445d-84a6-283dae38ba95 43406-0014 HUMAN OTC DRUG COUGH HP Arsenic Trioxide, Bryonia Alba Root, Cupric Acetate, Drosera Rotundifolia, Ipecac, Potassium Carbonate, Phosphorus, Pulsatilla Vulgaris, Spongia Officinalis Skeleton, Roasted LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0015_66c900b0-533e-4d0f-b709-4a7a8a63c27b 43406-0015 HUMAN OTC DRUG CYSTOGES HP Berberis Vulgaris Root Bark, Lytta Vesicatoria, Clematis Recta Flowering Top, Canis Lupus Familiaris Milk, Lycopodium Clavatum Spore, Pulsatilla Vulgaris, Sarsaparilla, Sepia Officinalis Juice, Delphinium Staphysagria Seed LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; CLEMATIS RECTA FLOWERING TOP; CANIS LUPUS FAMILIARIS MILK; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SARSAPARILLA; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0017_db7d1ef7-bb7d-4f19-a7c6-34002ac9079e 43406-0017 HUMAN OTC DRUG DIZZINESS HP Oyster Shell Calcium Carbonate Crude, Chenopodium Ambrosioides, Anamirta Cocculus Seed, Conium Maculatum Flowering Top, Strychnos Nux-Vomica Seed, Phosphorus, Pulsatilla Vulgaris, Silicon Dioxide LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CHENOPODIUM AMBROSIOIDES; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0018_5b11c3df-36e7-41e9-bcca-08df6d2217d3 43406-0018 HUMAN OTC DRUG EAR INFLAM HP Atropa Belladonna Root 30X, Conium Maculatum Flowering Top 30X, Solanum Dulcamara Top 30X, Calcium Sulfide 30X, Potassium Dichromate 30X, Mercurius Solubilis 30X, Pulsatilla Vulgaris 30X, Silicon Dioxide 30X LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ATROPA BELLADONNA ROOT; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; CALCIUM SULFIDE; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0019_f932d6f9-1781-4dd2-bb7c-44b40c2654a7 43406-0019 HUMAN OTC DRUG ECZEMA HP Arsenic Trioxide 30X, Oyster Shell Calcium Carbonate, Crude 30X, Graphite 30X, Mercurius Solubilis 30X, Daphne Mezereum Bark 30X, Toxicodendron Pubescens Leaf 30X, Sepia Officinalis Juice 30X, Sulfur 30X LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0020_0159af68-7743-4adf-bbce-ec7ce5016c16 43406-0020 HUMAN OTC DRUG ENURESIS HP Apis Mellifera 30C, Silver Nitrate 30C, Barium Carbonate 30C, Atropa Belladonna 30C, Causticum 30C, Equisetum Hyemale 30C, Iodine 30C, Wood Creosote 30C, Sodium Chloride 30C, Nitric Acid 30C, Phosphorus 30C, Pulsatilla Vulgaris 30C, Thuja Occidentalis Leafy Twig 30C LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. APIS MELLIFERA; SILVER NITRATE; BARIUM CARBONATE; ATROPA BELLADONNA; CAUSTICUM; EQUISETUM HYEMALE; IODINE; WOOD CREOSOTE; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0021_b995f789-981d-46b7-93f9-6863a722cdc8 43406-0021 HUMAN PRESCRIPTION DRUG FIBROMYALGIA HP Aluminum Oxide 30C, Silver Nitrate 30C, Berberis Vulgaris Fruit 30C, Conium Maculatum Flowering Top 30C, Iron 30C, Gelsemium Sempervirens Root 30C, Guaiacum Officinale Resin 30C, Hydrogen 30C, Lachesis Muta Venom 30C, Phosphoric Acid 30C, Toxicodendron Pubescens Leaf 30C LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ALUMINUM OXIDE; SILVER NITRATE; BERBERIS VULGARIS FRUIT; CONIUM MACULATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; GUAIACUM OFFICINALE RESIN; HYDROGEN; LACHESIS MUTA VENOM; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0022_49afea13-0cce-439e-82a6-ccfeb6b04309 43406-0022 HUMAN OTC DRUG FLU HP Aconitum Napellus, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Ferrum Phosphoricum, Gelsemium Sempervirens Root LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0025_1557667d-81de-48e0-8063-1bd56d01fec9 43406-0025 HUMAN OTC DRUG HEADACHE HP Silver Nitrate, Atropa Belladonna, Bryonia Alba Root, Gelsemium Sempervirens Root, Nitroglycerin, Lachesis Muta Venom, Lycopodium Clavatum Spore, Melilotus Officinalis Top, Sodium Chloride, Strychnos Nux-Vomica Seed, Silicon Dioxide, Spigelia Anthelmia LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. SILVER NITRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; NITROGLYCERIN; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MELILOTUS OFFICINALIS TOP; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0026_716f8bac-c57c-4925-95b0-ef44809c7b43 43406-0026 HUMAN OTC DRUG HYPERT HP Arnica Montana, Gold, Selenicereus Grandiflorus Stem, Oyster Shell Calcium Carbonate, Crude, Sodium Chloride, Strychnos Nux-Vomica Seed, Phosphorus, Solidago Virgaurea Flowering Top LIPSTICK ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARNICA MONTANA; GOLD; SELENICEREUS GRANDIFLORUS STEM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SOLIDAGO VIRGAUREA FLOWERING TOP 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0027_ef899e61-b830-4060-a350-e70a8a72fed4 43406-0027 HUMAN OTC DRUG INSOMNIA HP Arsenic Trioxide, Arabica Coffee Bean, Potassium Carbonate, Magnesium Carbonate, Strychnos Nux-Vomica Seed, Passiflora Incarnata Top, Sepia Officinalis Juice, Valerian LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; ARABICA COFFEE BEAN; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA TOP; SEPIA OFFICINALIS JUICE; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0028_5b40b6e3-6cc5-486b-8e4c-93594be11baf 43406-0028 HUMAN OTC DRUG LIVER GALLBLADDER HP Atropa Belladonna, Chelidonium Majus, Citrullus Colocynthis Fruit Pulp, Lycopodium Clavatum Spore, Sodium Sulfate, Strychnos Nux-Vomica Seed, Phosphorus, Pulsatilla Vulgaris, Veratrum Album Root LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ATROPA BELLADONNA; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0030_773b6f34-fff9-4aad-869e-6dab1ba19e7b 43406-0030 HUMAN OTC DRUG MENOPAUSE HP Atropa Belladonna, Black Cohosh, Lachesis Muta Venom, Strychnos Nux-Vomica Seed, Pulsatilla Vulgaris, Claviceps Purpurea Sclerotium, Sepia Officinalis Juice, Ustilago Maydis LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ATROPA BELLADONNA; BLACK COHOSH; LACHESIS MUTA VENOM; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; USTILAGO MAYDIS 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0032_67096693-fba2-4dbb-b473-c11d28f66957 43406-0032 HUMAN OTC DRUG NAUSEA VOMITING HP Arsenic Trioxide, Anamirta Cocculus Seed, Ipecac, Wood Creosote, Kerosene, Sanguinaria Canadensis Root, Tobacco Leaf LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; ANAMIRTA COCCULUS SEED; IPECAC; WOOD CREOSOTE; KEROSENE; SANGUINARIA CANADENSIS ROOT; TOBACCO LEAF 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0033_4450d0ab-885c-4734-aad8-b997deb1d8ea 43406-0033 HUMAN OTC DRUG NEURO PAIN HP Amanita Muscaria Var. Muscaria, Onion, Arnica Montana Root, Hypericum Perforatum, Lycopodium Clavatum Spore, Mercurius Solubilis, Phosphorus, Lead LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AMANITA MUSCARIA VAR. MUSCARIA; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; LEAD; ONION; ARNICA MONTANA ROOT; HYPERICUM PERFORATUM 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0034_30fdd1d1-f8f9-49b4-8eed-e70e5091cfaa 43406-0034 HUMAN OTC DRUG OSTEOPOROSIS HP Arsenic Trioxide, Gold, Oyster Shell Calcium Carbonate, Crude, Calcium Fluoride, Hydrofluoric Acid, Hekla Lava, Toxicodendron Pubescens Leaf, Silicon Dioxide, Delphinium Staphisagria Seed, Comfrey Leaf LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CALCIUM PHOSPHATE; HYDROFLUORIC ACID; HEKLA LAVA; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; COMFREY LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0035_50e58a51-4a75-4490-8aa3-b627c436e53c 43406-0035 HUMAN OTC DRUG RIGIDITY HP Aluminum Oxide, Arsenic Trioxide, Causticum, Conium Maculatum Flowering Top, Cupric Acetate, Gelsemium Sempervirens Root, Strychnos Ignatii Seed, Lachesis Muta Venom, Mercurius Solubilis, Phosphorus, Lead, Zinc LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ALUMINUM OXIDE; ARSENIC TRIOXIDE; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; CUPRIC ACETATE; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PHOSPHORUS; LEAD; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0037_fc6ae8a0-0ba3-4354-9645-fac9d9e9f33a 43406-0037 HUMAN OTC DRUG PMS HP Atropa Belladonna, Lachesis Muta Venom, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Strychnos Nux-Vomica Seed, Pulsatilla Vulgaris, Sepia Officinalis Juice LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ATROPA BELLADONNA; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0038_fc9c1141-9ff0-4a21-b676-cd0724d01ea1 43406-0038 HUMAN OTC DRUG PNEUMO HP Ammonium Chloride, Antimony Potassium Tartrate, Arsenic Trioxide, Oyster Shell Calcium Carbonate, Crude, Lobelia Inflata, Sodium Sulfate, Spongia Officinalis Skeleton, Roasted, Phosphorus LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AMMONIUM CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LOBELIA INFLATA; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 43406-0039_168c2935-de22-4a32-83d5-5b51d15e44f0 43406-0039 HUMAN OTC DRUG PROSTATE HP Clematis Recta Flowering Top, Conium Maculatum Flowering Top, Lycopodium Clavatum Spore, Mercuric Chloride, Pulsatilla Vulgaris, Saw Palmetto, Selenium, Sepia Officinalis Juice, Delphinium Staphisagria Seed, Thuja Occidentalis Leafy Twig LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0040_06739c6b-bbf8-4691-80b3-f15cf71a507c 43406-0040 HUMAN OTC DRUG PSORIASIS HP Clematis Recta Flowering Top, Arsenic Triiodide, Sodium Borate, Oyster Shell Calcium Carbonate, Crude, Graphite, Daphne Mezereum Bark, Proteus Morganii, Sodium Chloride, Phytolacca Americana Root, Sepia Officinalis Juice, Sulfur, Thyroid LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. CLEMATIS RECTA FLOWERING TOP; ARSENIC TRIIODIDE; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; DAPHNE MEZEREUM BARK; PROTEUS MORGANII; SODIUM CHLORIDE; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; SULFUR; THYROID, UNSPECIFIED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 43406-0042_97f36e74-0594-44a4-99e1-7f14bcdbbd3e 43406-0042 HUMAN OTC DRUG SCIATICA HP Aesculus Hippocastanum Bark, Aconitum Napellus, Colchicum Autumnale Bulb, Hypericum Perforatum, Magnesium Phosphate, Dibasic Trihydrate, Lead, Toxicodendron Pubescens Leaf, Arnica Montana LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AESCULUS HIPPOCASTANUM FLOWER; ACONITUM NAPELLUS; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; LEAD; TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 43406-0043_b36a9804-6dc1-4e08-994f-2d708f28d830 43406-0043 HUMAN OTC DRUG SCROPHULOUS HP Barium Carbonate, Bromine, Oyster Shell Calcium Carbonate, Crude, Conium Maculatum Flowering Top, Ferrous Iodide, Mercurius Solubilis, Phytolacca Americana Root, Toxicodendron Pubescens Leaf, Silicon Dioxide LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BARIUM CARBONATE; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; FERROUS IODIDE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0045_5f6dab29-b520-4200-bbcd-bee10f7afeb3 43406-0045 HUMAN OTC DRUG SINUS HP Ambrosia Artemisiifolia, Arsenic Trioxide, Calcium Sulfide, Potassium Dichromate, Potassium Sulfate, Lycopodium Clavatum Spore, Mercurius Solubilis, Sodium Chloride, Phosphorus, Pulsatilla Vulgaris, Sepia Officinalis Juice, Silicon Dioxide, Thuja Occidentalis Leafy Twig LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; POTASSIUM SULFATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0047_5873541a-980c-411f-8567-f73581e9adeb 43406-0047 HUMAN OTC DRUG SUCUR II Silver, Giant Puffball, Colchicum Autumnale Bulb, Chamaelirium Luteum Root, Strychnos Ignatii Seed, Lactic Acid, DL-, Lycopodium Clavatum Spore, Phosphoric Acid, Phosphorus, Syzygium Cumini Seed, Uranyl Nitrate Hexahydrate LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. SILVER; GIANT PUFFBALL; COLCHICUM AUTUMNALE BULB; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0048_00e346e5-b2be-4f05-ba56-34808c57727f 43406-0048 HUMAN PRESCRIPTION DRUG SURG HP Echinacea Angustifolia, Hypericum, Phosphorus, Rancid Beef, Silicon Dioxide, Delphinium Staphisagria Seed, Delphinium Staphisagria Seed, Comfrey Root, Arnica Montana Root LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; PHOSPHORUS; RANCID BEEF; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ARNICA MONTANA ROOT; ARNICA MONTANA ROOT 30; 30; 30; 30; 30; 30; 30; 30; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0050_0a792f69-2f64-49d1-aa0f-71ea92b0a80c 43406-0050 HUMAN OTC DRUG Varico HP Calcarea Fluorica, Activated Charcoal, Hamamelis Virginiana Root Bark / Stem Bark, Lachesis Muta Venom, Lycopodium Clavatum Spore, Pulsatilla Vulgaris, Claviceps Purpurea Sclerotium, Delphinium Staphisagrea Seed, Zinc LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. CALCIUM FLUORIDE; ACTIVATED CHARCOAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM; DELPHINIUM STAPHISAGRIA SEED; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0051_98cfe986-47ca-4a19-af15-6e39077c725c 43406-0051 HUMAN OTC DRUG VERMA HP Barium Carbonate, Oyster Shell Calcium Carbonate, Crude, Artemisia Cina Flower, Iron, Mercuric Sulfate, Sodium Phosphate, Dibasic, Heptahydrate, Schoenocaulon Officinale Seed, Spigelia Anthelmia, Teucrium Marum LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARTEMISIA CINA FLOWER; IRON; MERCURIC SULFATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SCHOENOCAULON OFFICINALE SEED; SPIGELIA ANTHELMIA; TEUCRIUM MARUM 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0052_8d547ff9-d2f0-45fb-ad82-d7efd039c619 43406-0052 HUMAN OTC DRUG VIRAL HP Arsenic Trioxide, Atropa Belladonna, Echinacea Angustifolia, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Lycopodium Clavatum Spore, Phosphoric Acid, Phosphorus, Rancid Beef, Toxicodendron Pubescens Leaf LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; ARSENIC TRIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0053_b0c4eb8c-a36d-4d01-aa1c-d9075e1f720c 43406-0053 HUMAN OTC DRUG Weight Management HP Arsenic Trioxide, Gold, Oyster Shell Calcium Carbonate, Crude, Iodine, Lycopodium Clavatum Spore, Sodium Chloride, Strychnos Nux-Vomica Seed, Phosphoric Acid, Phosphorus, Phytolacca Americana Root, Pulsatilla Vulgaris, Sepia Officinalis Juice, Sulfur LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0056_7baff66d-65ba-403d-9d99-1c4f10655152 43406-0056 HUMAN OTC DRUG COLIC CP Aethusa Cynapium, Aluminum Oxide, Bryonia Alba Root, Oyster Shell Calcium Carbonate Crude, Matricaria Recutita, Lycopodium Clavatum Spore, Phosphorus, Anemone Pulsatilla, Silicon Dioxide, Sulfur. LIQUID ORAL 20100101 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AETHUSA CYNAPIUM; ALUMINUM OXIDE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; ANEMONE PULSATILLA; SILICON DIOXIDE; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0057_af23f594-719a-4977-93f3-bdc95898bc11 43406-0057 HUMAN OTC DRUG CONSTIPATION CP Aluminum Oxide, Bryonia Alba Root, Matricaria Recutita, Graphite, Lycopodium Clavatum Spore, Strychnos Nux-Vomica Seed, Silicon Dioxide, Sulfur, Sodium Chloride, Magnesium Chloride, Lead, Sepia Officinalis Juice. LIQUID ORAL 20100101 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ALUMINUM OXIDE; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE; SULFUR; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; LEAD; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0069_9b73d14c-7886-46ee-b4d5-25cf27bf2349 43406-0069 HUMAN OTC DRUG COLD Baptisia Tintoria Root, Echinacea Angustifolia, Eupatoriom Perfoliatum Flowering Top, Lomatium Dissectum Root, Pueraria Montana Var. Lobata Root, Trifolium Pratense Flower, Pnytolacca Americana Root, Onion, Arsenic Triiodode, Barium Carbonate, Bromide, Oyster Shell Calcium Carbonate Crude, Potassium Chloride, Mercurius Solubilis, Silicon Dioxide LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; PUERARIA MONTANA VAR. LOBATA ROOT; TRIFOLIUM PRATENSE FLOWER; PHYTOLACCA AMERICANA ROOT; ONION; ARSENIC TRIIODIDE; BARIUM CARBONATE; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHLORIDE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; SILICON DIOXIDE 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0070_be3b9faf-57f1-4278-bc8a-12f572513d00 43406-0070 HUMAN OTC DRUG CONSTIPATION Magnesium Carbonate, Magnesium Chloride, Aesculus Hippocastanum, Flos, Potassium Alum, Aluminum Oxide, Bryonia Alba Root, Strychnos Nux-Vomica Seed, Silicon Dioxide LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. MAGNESIUM CARBONATE; MAGNESIUM CHLORIDE; AESCULUS HIPPOCASTANUM FLOWER; POTASSIUM ALUM; ALUMINUM OXIDE; BRYONIA ALBA ROOT; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0071_d3b754f0-5a03-44e6-bbc9-0ace31b246ce 43406-0071 HUMAN OTC DRUG DEPRESSION American Ginseng, Black Cohosh, Spigelia Anthelmia, Silver Nitrate, Arsenic Trioxide, Gold, Strychnos Ignatti Seed, Lachesis Muta Venom, Lycopodium Clavatum Spore, Sodium Chloride, Phosphoric Acid, Platinum, Pulsatilla Vulgaris, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig, LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AMERICAN GINSENG; BLACK COHOSH; SPIGELIA ANTHELMIA; SILVER NITRATE; ARSENIC TRIOXIDE; GOLD; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORIC ACID; PLATINUM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0072_397400d7-25b3-409f-ab41-b797da25e64d 43406-0072 HUMAN OTC DRUG DIGESTION Centella Asiatica, Gentiana Lutea Root, Sambucus Niger Flowering Top, Arsenic Trioxide, Bismuth Subnitrate, Activated Charcoal, Potassium Dichromate, Lycopodium Clavatium Spore, Strychnos Nux-Vomica Seed, Phosphorus, Pulsatilla VulgarisPhosphorus, Pulsatilla Vulgaris LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. CENTELLA ASIATICA; GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; ARSENIC TRIOXIDE; BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS 1; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0073_c8d4ff50-4e6c-4d09-964c-dfdea85ca072 43406-0073 HUMAN OTC DRUG EYE - CATARACT Euphrasia Stricta, Spigelia Anthelmia, Bilberry, Arsenic Trioxide, Calcium Fluoride, Causticum, Gelsemium Sempervirens Root, Magnesium Carbonate, Mercurius Solubilis, Osmium, Phosphorus, Physostigma Venenosum Seed , Silicon Dioxide LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. EUPHRASIA STRICTA; SPIGELIA ANTHELMIA; BILBERRY; ARSENIC TRIOXIDE; CALCIUM FLUORIDE; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM CARBONATE; MERCURIUS SOLUBILIS; OSMIUM; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0075_e2cd08dd-c58b-4575-ab45-330e96c11ea6 43406-0075 HUMAN OTC DRUG HIVES Echina Angustifolia, Apis Mellifera, Arsenic Trioxide, Phenol, Ledum Palustre, Toxicodendron Pubescens Leaf, Sulfur, Urtica Urens LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creationa, Inc. ECHINACEA ANGUSTIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; PHENOL; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; SULFUR; URTICA URENS 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0078_476a9f9a-ec5d-49c0-9189-1eb55be43416 43406-0078 HUMAN OTC DRUG INJURY Calendula Officinalis Flowering Top, Comfrey Root, Arnica Montana, Bellis Perennis, Bryonia Alba Root, Hypericum Perforatum, Ledum Palustre Twig, Phosphorus, Toxicodendron Pubescens Leaf, Ruta Graveolens Flowering Top, Delphinium Staphisagria Seed, Rancid Beef LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; RANCID BEEF 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0095_c66bf8d1-7f22-4308-9528-becd068ace49 43406-0095 HUMAN OTC DRUG EDEMA HP Apis Mellifera 30X, Arsenic Trioxide 30X, Cinchona Officinalis Bark 30X, Digitalis 30X, Lachesis Muta Venom 30X, Lycopodium Clavatum Spore 30X, Sodium Sulfate 30X, Toxicodendron Pubescens Leaf 30X, Sambucus Nigra Flowering Top 30X, Strophanthus Hispidus Seed 30X LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; DIGITALIS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0099_40cf4b0e-e82f-449a-bc11-d7c6b9a97664 43406-0099 HUMAN OTC DRUG MOTION SICKNESS HP Arnica Montana, Bryonia Alba Root, Quinine Sulfate, Anamirta Cocculus Seed, Conium Maculatum Flowering Top, Strychnos Ignatii Seed, Ipecac, Potassium Carbonate, Strychnos Nux-Vomica Seed, Sepia Officinalis Juice, Tobacco Leaf, Veratrum Album Root LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARNICA MONTANA; BRYONIA ALBA ROOT; QUININE SULFATE; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; STRYCHNOS IGNATII SEED; IPECAC; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SEPIA OFFICINALIS JUICE; TOBACCO LEAF; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0106_50f235f6-940b-49a5-aff2-a2344e8d22ec 43406-0106 HUMAN OTC DRUG ALLERGY NEW ENGLAND MIX Betula Pubescens Bark, Artemisia Vulgaris Pollen, Plantago Lanceolata Pollen, Acer Pseudoplatanus Pollen, Betula Pubescens Bark, Evernia Prunastri Bark, Armaranthus Retroflexus Pollen, Pinus Massoniana Pollen, Tabuliformis Pollen, Ambrosia Artemisifolia Pollen, LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BETULA PUBESCENS BARK; ARTEMISIA VULGARIS POLLEN; PLANTAGO LANCEOLATA POLLEN; ACER PSEUDOPLATANUS POLLEN; EVERNIA PRUNASTRI; AMARANTHUS RETROFLEXUS POLLEN; PINUS MASSONIANA POLLEN; PINUS TABULIFORMIS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; RUMEX ACETOSELLA POLLEN; POPULUS ALBA POLLEN 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0108_332d3cbc-b705-4217-9eef-1b12b4c60c06 43406-0108 HUMAN OTC DRUG VITAL HP Arsenic Trioxide, Cadmium Sulfate, Oyster Shell Calcium Carbonate, Crude, Human Breast Tumor Cell, Conium Maculatum Flowering Top, Lycopodium Clavatum Spore, Gonorrheal Urethral Secretion Human, Phytolacca Americana Root, Scabies Lesion Lysate (Human), Sulfur, Treponemic Skin Canker Human, Thuja Occidentalis Leafy Twig LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; CADMIUM SULFATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; HUMAN BREAST TUMOR CELL; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; GONORRHEAL URETHRAL SECRETION HUMAN; PHYTOLACCA AMERICANA ROOT; SCABIES LESION LYSATE (HUMAN); SULFUR; TREPONEMIC SKIN CANKER HUMAN; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0112_0d828797-eebd-4727-8d0d-9a17e790f5d0 43406-0112 HUMAN OTC DRUG RAD HP Arsenic Trioxide, Baptisia Tinctoria Root, Cadmium Sulfide, Calcium Fluoride, Lytta Vesicatoria, Human Breast Tumor Cell, Cinchona Officinalis Bark, Cobalt, Conium Maculatum Flowering Top, Hydrofluoric Acid, Goldenseal, Iodine, Ipecac, Wood Creosote, Phosphorus, Radium Bromide, Sepia Officinalis Juice, Silicon Dioxide, Uranyl Nitrate Hexahydrate LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CADMIUM SULFIDE; CALCIUM FLUORIDE; LYTTA VESICATORIA; HUMAN BREAST TUMOR CELL; CINCHONA OFFICINALIS BARK; COBALT; CONIUM MACULATUM FLOWERING TOP; HYDROFLUORIC ACID; GOLDENSEAL; IODINE; IPECAC; WOOD CREOSOTE; PHOSPHORUS; RADIUM BROMIDE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; URANYL NITRATE HEXAHYDRATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0113_d6b36a29-3060-4584-85dd-239ed337a713 43406-0113 HUMAN OTC DRUG CHEM HP Apis Mellifera, Arsenic Trioxide, Cadmium Sulphate, Oyster Shell Calcium Carbonate Crude, Activated Charcoal, Chelidonium Majus, Cinchona Officinalis Bark, Lycopodium Clavatum Spore, Mercurius Solubilis, Sodium Chloride, Strychnos Nux-Vomica Seed, Phosphorus, Pulsatilla Vulgaris, Sepia Officinalis Juice, Sulphur, Zinc LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; CADMIUM SULFATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SULFUR; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0114_93ffec3d-3e1b-47b9-9256-8040c81e0063 43406-0114 HUMAN OTC DRUG BITING INSECT ANTIGEN Apis Mellifera, Arnica Montana, Blatta Orientalis, Dieffenbachia Seguine, Cimex Lectularius, Culex Pipiens, Formica Rufa, Hypericum Perforatum, Latrodectus Mactans, Ledum Palustre Twig, Loxosceles Reclusa, Pediculus Humanus Var. Capitis, Pulex Irritans, Delphinium Staphisagria Seed, Vespa Crabro. LIQUID ORAL 20100101 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. APIS MELLIFERA; ARNICA MONTANA; BLATTA ORIENTALIS; DIEFFENBACHIA SEGUINE; CIMEX LECTULARIUS; CULEX PIPIENS; FORMICA RUFA; HYPERICUM PERFORATUM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; LOXOSCELES RECLUSA; PEDICULUS HUMANUS VAR. CAPITIS; PULEX IRRITANS; DELPHINIUM STAPHISAGRIA SEED; VESPA CRABRO 12; 30; 30; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0115_f9bd786c-1760-46b1-ba06-e6ce4c7270b0 43406-0115 HUMAN OTC DRUG CONTACT ALLERGY ANTIGEN Toxicodendron Diversilobum Leaf, Toxicodendron Pubescens Leaf, Toxicodendron Vernix Leafy Twig, Urtica Dioica, Semecarpus Anacardium Juice, Graphite, Daphne Mezereum Bark, Urtica Urens, Xerophyllum Asphodeloides LIQUID ORAL 20100101 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. TOXICODENDRON DIVERSILOBUM LEAF; TOXICODENDRON PUBESCENS LEAF; TOXICODENDRON VERNIX LEAFY TWIG; URTICA DIOICA; SEMECARPUS ANACARDIUM FRUIT; GRAPHITE; DAPHNE MEZEREUM BARK; URTICA URENS; XEROPHYLLUM ASPHODELOIDES 30; 30; 30; 30; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0124_79041e5c-c19b-4d8a-9a90-d76ae7ff7a1f 43406-0124 HUMAN OTC DRUG CENTROCODE American Ginseng, Adenosine Triphosphate, Corticotropin, Alfalfa, Bos Taurus Hypothalamus, Phytolacca Americana Root, Bos Taurus Pituitary Gland Posterior, Thyroid Unspecified, Iodine, Silicon Dioxide, Oster Shell Calcium Carbonate Crude, Strychnos Ignatii Seed, Iridium, Lachesis Muta Venom, Lycopodium Clavatum Spore, Sodium Chloride, Strychnos Nux-Vomica Seed, Phosphorus, Selenium, Uranyl Nitrate Hexahydrate. LIQUID ORAL 20100101 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AMERICAN GINSENG; ADENOSINE TRIPHOSPHATE; CORTICOTROPIN; ALFALFA; BOS TAURUS HYPOTHALAMUS; PHYTOLACCA AMERICANA ROOT; BOS TAURUS PITUITARY GLAND, POSTERIOR; THYROID, UNSPECIFIED; IODINE; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; IRIDIUM; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SELENIUM; URANYL NITRATE HEXAHYDRATE 3; 6; 6; 6; 6; 6; 6; 6; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0127_c17c4aca-37a1-4647-b911-9120ada4f95b 43406-0127 HUMAN OTC DRUG SNORING HP Ailanthus Altissima Flowering Twig, Antimony Potassium Tartrate, Arsenic Trioxide, Atropa Belladonna, Camphor (Natural), Chamomile, Copper, Digitalis, Strychnos Ignatii Seed, Canis Lupus Familiaris Milk, Strychnos Nux-Vomica Seed LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AILANTHUS ALTISSIMA FLOWERING TWIG; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAMPHOR (NATURAL); CHAMOMILE; COPPER; DIGITALIS; STRYCHNOS IGNATII SEED; CANIS LUPUS FAMILIARIS MILK; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0131_15eef614-1118-4b42-afa2-7bcc9ef99ec4 43406-0131 HUMAN OTC DRUG Cardio HP Gold, Avena Sativa Flowering Top, Selenicereus Grandiflorus Stem, Digitalis Purpurea Whole, Lycopus Virginicus, Naja Naja Venom, Sodium Chloride, Phosphorus, Pulsatilla Patens, Valerian LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. GOLD; SELENICEREUS GRANDIFLORUS STEM; AVENA SATIVA FLOWERING TOP; DIGITALIS PURPUREA WHOLE; LYCOPUS VIRGINICUS; NAJA NAJA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA PATENS; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0152_ae13b690-a11a-4f95-ba0a-be534a2a9338 43406-0152 HUMAN PRESCRIPTION DRUG STIFF JOINTS HP Bryonia Alba Root, Colchicum Autumnale Bulb, Kalmia Latifolia Leaf, Ledum Palustre Twig, Lycopodium Clavatum Spore, Rhododendron Aureum Leaf, Toxicodendron Pubescens Leaf LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0587_956d645e-8d3f-4a1e-8508-82beece1455d 43406-0587 HUMAN OTC DRUG ALLERGY ATLANTIC MOLD MIX Alternaria Alternata, Aspergillus Fumigatus, Botrytis Cinerea, Rhizopus Stolonifer, Ustilago Maydis LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; BOTRYTIS CINEREA; RHIZOPUS STOLONIFER; USTILAGO MAYDIS 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0588_1e91e87b-b379-4c0b-9103-eb0bff560fe5 43406-0588 HUMAN OTC DRUG ALLERGY POLLEN Garlic, Echinacea Angustifolia, Solidago Virgaurea Flowering Top, Toxicodendron Pubescens Leaf, Onion, Ambrosia Artemisiifolia, Apis Mellifera, Arsenic TriOxide, Arsenic TriIodide, Euphrasia Stricta, Iodine, Histamine DiHydrochloride, Lycopodium Clavatum Spore, Mercurius Solubilis, Strychnos Nux-Vomica Seed, Sus Scrofa Pituitary Gland Posterior, Anemone Pulsatilla, Schoenocaulon Officinale Seed, Sulfur LIQUID ORAL 20150101 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. GARLIC; ECHINACEA ANGUSTIFOLIA; SOLIDAGO VIRGAUREA FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; ONION; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; EUPHRASIA STRICTA; IODINE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PITUITARY GLAND, POSTERIOR; ANEMONE PULSATILLA; SCHOENOCAULON OFFICINALE SEED; SULFUR 8; 8; 8; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0611_2614cb44-b7ca-4c9b-bdcb-82e7a31034e7 43406-0611 HUMAN OTC DRUG BONE HP Sodium Borate, Oyster Shell Calcium Carbonate Crude, Calcium Fluoride, Tribasic Calcium Phosphate, Eupatorium Perfoliatum Flowering Top, Iron, Hydrofluoric Acid, Hekla Lava, Toxicodendron Pubescens Leaf, Ruta Graveolens Flowering Top, Silicon Dioxide, Comfrey Root. LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; EUPATORIUM PERFOLIATUM FLOWERING TOP; IRON; HYDROFLUORIC ACID; HEKLA LAVA; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; COMFREY ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0612_c1ab8bb2-8e5b-4a36-93de-44340aae35f7 43406-0612 HUMAN OTC DRUG STRESS / FATIGUE Epinephrine, Thyroid Unspecified,Bos Taurus Pituitary Gland, Arsenic Trioxide, Oyster Shell Calcium Carbonate Crude, Conium Maculatum Flowering Top, Cortisone Acetate, Crotalus Horridus Horridus Venom, Iron, Strychnos Nux-Vomica Seed, Phosphoric Acid, Phosphorus, Selenium, Sepia Officinalis Juice, Zanthoxylum Americanum Bark LIQUID ORAL 20160101 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. EPINEPHRINE; THYROID, UNSPECIFIED; BOS TAURUS PITUITARY GLAND; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; CROTALUS HORRIDUS HORRIDUS VENOM; IRON; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; ZANTHOXYLUM AMERICANUM BARK 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 43406-0613_a6df6375-7317-4e3e-8aac-8bdff01baac0 43406-0613 HUMAN OTC DRUG GBLV HP Atropa Belladonna, Berberis Vulgaris Root Bark, Milk Thistle, Chelidonium Majus, Citrullus Colocynthis Fruit Pulp, Dioscorea Villosa Tuber, Goldenseal, Lycopodium Clavatum Spore, Sodium Sulfate, Strychnos Nux-Vomica Seed, Phosphorus, Anemone Pulsatilla, Veratrum Album Root LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE PULSATILLA; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0617_3331bc2f-9327-4614-af72-73ebdc415de8 43406-0617 HUMAN PRESCRIPTION DRUG FCS HP Epinephrine, Glutamic Acid, Mucuna Pruriens Seed, Niacinamide, Serotonin, Ubidecarenone, Corticotropin, Ascorbic Acid, Adenosine Triphosphate, Insulin Pork, Sus Scrofa Parathyroid Gland, Sus Scrofa Pituitary Gland, Thiamine Hydrochloride, Thyroid, Anhydrous Citric Acid, Herring Sperm DNA, Saccharomyces Cerevisiae RNA, Anacardium Occidentale Fruit, Arsenic Trioxide, Aspartic Acid, Barium Carbonate, Oyster Shell Calcium Carbonate Crude, Lycopodium Clavatum Spore, Anemone Pulsatilla, Datura Stramonium, Sulfur LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. EPINEPHRINE; GLUTAMIC ACID; MUCUNA PRURIENS SEED; NIACINAMIDE; SEROTONIN; UBIDECARENONE; CORTICOTROPIN; ASCORBIC ACID; ADENOSINE TRIPHOSPHATE; INSULIN PORK; SUS SCROFA PARATHYROID GLAND; SUS SCROFA PITUITARY GLAND; THIAMINE HYDROCHLORIDE; THYROID, UNSPECIFIED; ANHYDROUS CITRIC ACID; HERRING SPERM DNA; SACCHAROMYCES CEREVISIAE RNA; ANACARDIUM OCCIDENTALE FRUIT; ARSENIC TRIOXIDE; ASPARTIC ACID; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYCOPODIUM CLAVATUM SPORE; ANEMONE PULSATILLA; DATURA STRAMONIUM; SULFUR 30; 30; 30; 8; 30; 8; 30; 6; 6; 6; 6; 6; 6; 6; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 43406-0622_ffa78e0c-ec59-4196-82a0-1aad57e2c651 43406-0622 HUMAN OTC DRUG BACK HP Aconitum Napellus, Horse Chestnut, Colchicum Autumnale Bulb, Hypericum Perforatum, Magnesium Phosphate Dibasic Trihydrate, Lead, Toxicodendron Pubescens Leaf, Arnica Montana LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACONITUM NAPELLUS; HORSE CHESTNUT; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; LEAD; TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 43406-0623_b142d327-70f6-491f-a1d1-e799e410dbaa 43406-0623 HUMAN OTC DRUG GERM HP Apis Mellifera, Arsenic Trioxide, Atropa Belladonna, Matricaria Recutita, Lachesis Muta Venom, Mercurius Solubilis, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, Silicon Dioxide LIQUID ORAL 20160101 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 300 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0625_865da7f4-c240-4686-8ea8-1d7085ddcd38 43406-0625 HUMAN OTC DRUG BLISTER HP Juglans Cinerea Branch Bark/Root Bark, Potassium Iodide, Lycopodium Clavatum Spore, Mercury, Sodium Chloride, Nitric Acid, Phosphorus, Ranunculus Bulbosus, Toxicodendron Pubescens Leaf, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig. LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; MERCURY; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORUS; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0626_496d921c-e7b9-49a6-92d6-395441846a92 43406-0626 HUMAN OTC DRUG CONGESTION HP Ammonium Chloride, Antimony Potassium Tartrate, Arsenic Trioxide, Oyster Shell Calcium Carbonate, Crude, Lobelia Inflata, Sodium Sulfate, Spongia Officinalis Skeleton, Roasted, Phosphorus LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. AMMONIUM CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LOBELIA INFLATA; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 43406-0627_255f0fbf-6f35-4069-ae8b-9ca17a1b46af 43406-0627 HUMAN OTC DRUG SWELLING HP Apis Mellifera 30X, Arsenic Trioxide 30X, Cinchona Officinalis Bark 30X, Digitalis 30X, Lachesis Muta Venom 30X, Lycopodium Clavatum Spore 30X, Sodium Sulfate 30X, Toxicodendron Pubescens Leaf 30X, Sambucus Nigra Flowering Top 30X, Strophanthus Hispidus Seed 30X LIQUID ORAL 20070529 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; DIGITALIS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0628_37c6af91-9f5f-47fa-8d08-c5d01f6bc5d7 43406-0628 HUMAN PRESCRIPTION DRUG INJURY HP Arnica Montana, Echinacea Angustifolia, Hypericum Perforatum, Phosphorus, Rancid Beef, Silicon Dioxide, Delphinium Staphisagria Seed, Comfrey Root LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ARNICA MONTANA; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; PHOSPHORUS; RANCID BEEF; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT 200; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0629_a2e118a9-62fd-4fda-b0f0-70b2f9e02a9e 43406-0629 HUMAN OTC DRUG IODIUM HP Barium Carbonate, Oyster Shell Calcium Carbonate, Crude, Fucus Vesiculosus, Iodine, Sodium Chloride, Pulsatilla Vulgaris, Spongia Officinalis Skeleton, Roasted, Thyroid LIQUID ORAL 20160101 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FUCUS VESICULOSUS; IODINE; SODIUM CHLORIDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID, UNSPECIFIED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 43406-0637_13e22457-cfc3-4926-93eb-948265f1adee 43406-0637 HUMAN OTC DRUG BELLA HP Atropa Belladonna, Conium Maculatum Flowering Top, Solanum Dulcamara Top, Calcium Sulfide, Potassium Dichromate, Mercurius Solubilis, Anemone Pulsatilla, Silicon Dioxide, Matricaria Recutita. LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ATROPA BELLADONNA; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; CALCIUM SULFIDE; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; ANEMONE PULSATILLA; SILICON DIOXIDE; MATRICARIA RECUTITA 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 43406-0638_7cf3bdfd-776e-4692-9283-ca37b5b50139 43406-0638 HUMAN OTC DRUG BELLA CP Aconitum Napellus, Apis Mellifera, Atropa Belladonna, Oyster Shell Clacium Carbonate Crude, Calcium Sulfate Anhydrous, Causticum, Matricaria Recutita, Graphite, Calcium Sulfide, Potassium Dichromate, Lachesis Muta Venom, Lycopodium Clavatum Spore, Mercurius Solubilis, Anemone Pulsatilla, Silicon Dioxide, Sulfur, Thuja Occidentalis Leafy Twig. LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM SULFATE ANHYDROUS; CAUSTICUM; MATRICARIA RECUTITA; GRAPHITE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; ANEMONE PULSATILLA; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43406-0641_f4976ae9-dd9c-4b41-8a67-de1850349576 43406-0641 HUMAN OTC DRUG ALUMIZEN Garlic, Avena Sativa Flowering Top, Berberis Vulgaris Root Bark, Arctium Lappa Root, Phytolacca Americana Root, Solidago Virgaurea Flowering Top, Aluminum Oxide, Silver Nitrate, Barium Carbonate, Beryllium, Cadmium, Copper, Hydrofluoric Acid, Indium, Iodine, Lithium Carbonate, Mercurius Solubilis, Nickel Carbonate Hydroxide Tetrahydrate, Nitrous Oxide, Lead, Selenium, Strontium Carbonate, Titanium, Arsenic Trioxide, Sodium Chloride, Strychnos Nux-Vomica Seed. LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Natural Creations, Inc. GARLIC; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; ALUMINUM OXIDE; SILVER NITRATE; BARIUM CARBONATE; BERYLLIUM; CADMIUM; COPPER; HYDROFLUORIC ACID; INDIUM; IODINE; LITHIUM CARBONATE; MERCURIUS SOLUBILIS; NICKEL CARBONATE HYDROXIDE TETRAHYDRATE; NITROUS OXIDE; LEAD; SELENIUM; STRONTIUM CARBONATE; TITANIUM; ARSENIC TRIOXIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 43419-001_e7bb91b4-f4cd-43b0-bb76-429d948a0dd0 43419-001 HUMAN OTC DRUG Sulwhasoo Lumitouch Base OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 g/30mL; g/30mL; g/30mL E 20171231 43419-002_ebf2ff60-8042-49fb-a850-fdd2b5a541e2 43419-002 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation No. 21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 g/30mL; g/30mL; g/30mL E 20171231 43419-003_ebf2ff60-8042-49fb-a850-fdd2b5a541e2 43419-003 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation No. 23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 g/30mL; g/30mL; g/30mL E 20171231 43419-004_832e72a8-86b7-4c44-ba55-9883d79fdafa 43419-004 HUMAN OTC DRUG Sulwhasoo Age-veil UV protection OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 1.8; 3.2; 1.768; .0412 g/40mL; g/40mL; g/40mL; g/40mL; g/40mL N 20181231 43419-005_8cce279e-f151-4b91-9635-b0002554b109 43419-005 HUMAN OTC DRUG SULWHASOO SNOWISE BRIGHTENING BB BASE NO.1 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20111005 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; .996; 2.352 g/30mL; g/30mL; g/30mL E 20171231 43419-006_8cce279e-f151-4b91-9635-b0002554b109 43419-006 HUMAN OTC DRUG SULWHASOO SNOWISE BRIGHTENING BB BASE NO.2 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20111005 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; .996; 2.352 g/30mL; g/30mL; g/30mL E 20171231 43419-007_ebf2ff60-8042-49fb-a850-fdd2b5a541e2 43419-007 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation No. 25 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20111015 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 g/30mL; g/30mL; g/30mL E 20171231 43419-008_2de54174-ec98-41b2-b74e-a21fe8cc8999 43419-008 HUMAN OTC DRUG Sulwhasoo Lumitouch Compact No.21 Natural Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .56; 3.3572; 1.3706 g/14g; g/14g; g/14g N 20181231 43419-009_2de54174-ec98-41b2-b74e-a21fe8cc8999 43419-009 HUMAN OTC DRUG Sulwhasoo Lumitouch Compact No.23 True Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .56; 3.3572; 1.3706 g/14g; g/14g; g/14g N 20181231 43419-010_a0f06994-ffcb-49fd-b61c-634696e7aa54 43419-010 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .246; .291 g/30mL; g/30mL; g/30mL N 20181231 43419-011_a0f06994-ffcb-49fd-b61c-634696e7aa54 43419-011 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .246; .291 g/30mL; g/30mL; g/30mL N 20181231 43419-012_a0f06994-ffcb-49fd-b61c-634696e7aa54 43419-012 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .246; .291 g/30mL; g/30mL; g/30mL N 20181231 43419-013_73376ae2-606e-46b1-9749-2427abc3de5e 43419-013 HUMAN OTC DRUG Sulwhasoo Snowise Foundation OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .468; .8667; .1764 g/9g; g/9g; g/9g N 20181231 43419-014_73376ae2-606e-46b1-9749-2427abc3de5e 43419-014 HUMAN OTC DRUG Sulwhasoo Snowise Foundation OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .468; .8667; .1764 g/9g; g/9g; g/9g N 20181231 43419-015_91ed8fd4-5c5e-4157-a22c-7d5c51c1a1df 43419-015 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation SPF 25 No.21 Natural Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .352; .4697; .2156 g/11g; g/11g; g/11g N 20181231 43419-016_91ed8fd4-5c5e-4157-a22c-7d5c51c1a1df 43419-016 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation SPF 25 No 23. True Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .352; .4697; .2156 g/11g; g/11g; g/11g N 20181231 43419-017_91ed8fd4-5c5e-4157-a22c-7d5c51c1a1df 43419-017 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation SPF 25 No 25. Dark Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .352; .4697; .2156 g/11g; g/11g; g/11g N 20181231 43419-018_a879375f-07d3-4d04-941a-b31b3122e5dc 43419-018 HUMAN OTC DRUG Sulwhasoo Lumitouch Base SPF 15 No.40 Light Violet OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .249; .294 g/30mL; g/30mL; g/30mL N 20181231 43419-019_5b8fb785-8257-464b-ba3e-791e1210d5bd 43419-019 HUMAN OTC DRUG Sulwhasoo Lumitouch Base SPF 15 No. 60 Light Green OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .249; .294 g/30mL; g/30mL; g/30mL N 20181231 43419-020_9b0f74e0-05e8-4d0c-b6e4-fb9e2f15d676 43419-020 HUMAN OTC DRUG Sulwhasoo Lumitouch Base OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 mL/30mL; mL/30mL; mL/30mL N 20181231 43419-021_d7c986c3-d47e-4994-97b5-e0e0c9529ba6 43419-021 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation No.21 Natural Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 mL/30mL; mL/30mL; mL/30mL N 20181231 43419-022_d7c986c3-d47e-4994-97b5-e0e0c9529ba6 43419-022 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation No.21 Natural Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .498; .588 mL/30mL; mL/30mL; mL/30mL N 20181231 43419-023_31ded521-3a39-4e26-baf8-cd3d448956d2 43419-023 HUMAN OTC DRUG Sulwhasoo EVENFAIR SMOOTHING FOUNDATION SPF25 NO. 2 medium beige OCTINOXATE LIQUID TOPICAL 20121123 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL N 20181231 43419-024_31ded521-3a39-4e26-baf8-cd3d448956d2 43419-024 HUMAN OTC DRUG Sulwhasoo EVENFAIR SMOOTHING FOUNDATION SPF25 NO. 3 MEDIUM OCHER OCTINOXATE LIQUID TOPICAL 20121123 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL N 20181231 43419-025_113926fa-00ab-4023-94e2-5181590dcf9c 43419-025 HUMAN OTC DRUG Sulwhasoo EVENFAIR SMOOTHING FOUNDATION SPF25 NO.2 MEDIUM BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20121123 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .32; .4268; .196 g/10g; g/10g; g/10g N 20181231 43419-026_113926fa-00ab-4023-94e2-5181590dcf9c 43419-026 HUMAN OTC DRUG Sulwhasoo EVENFAIR SMOOTHING FOUNDATION SPF25 NO.3 MEDIUM OCHER OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20121123 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .32; .4268; .196 g/10g; g/10g; g/10g N 20181231 43419-027_7aafcd71-ba80-4ed2-8b3f-47dd7955ce4b 43419-027 HUMAN OTC DRUG Sulwhasoo evenfair smoothing makeup base NO. 1 OCTINOXATE LOTION TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL N 20181231 43419-028_7aafcd71-ba80-4ed2-8b3f-47dd7955ce4b 43419-028 HUMAN OTC DRUG Sulwhasoo EVENFAIR SMOOTHING MAKEUP BASE NO. 2 OCTINOXATE LOTION TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL N 20181231 43419-029_67734c96-a867-4277-af5a-4bc3a9440a93 43419-029 HUMAN OTC DRUG Sulwhasoo SNOWISE BRIGHTENING SERUM BB OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.4276; 1.151376; 2.718912 g/30mL; g/30mL; g/30mL N 20181231 43419-030_67734c96-a867-4277-af5a-4bc3a9440a93 43419-030 HUMAN OTC DRUG SulwhasooSNOWISE BRIGHTENING SERUM BB OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.4276; 1.151376; 2.718912 g/30mL; g/30mL; g/30mL N 20181231 43419-031_2e0c3863-69ed-4ea6-8a02-924888263cc0 43419-031 HUMAN OTC DRUG SULWHASOO EVENFAIR PERFECTING CUSHION NO.21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-032_2e0c3863-69ed-4ea6-8a02-924888263cc0 43419-032 HUMAN OTC DRUG SULWHASOO EVENFAIR PERFECTING CUSHION NO.23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-033_2e0c3863-69ed-4ea6-8a02-924888263cc0 43419-033 HUMAN OTC DRUG SULWHASOO EVENFAIR PERFECTING CUSHION NO.25 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-034_3f9d14b8-25cf-442b-baff-466d1ba03b9f 43419-034 HUMAN OTC DRUG SULWHASOO EVENFAIR COMPACT NO.21 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE .22; 2.2 g/11g; g/11g N 20181231 43419-035_3f9d14b8-25cf-442b-baff-466d1ba03b9f 43419-035 HUMAN OTC DRUG SULWHASOO EVENFAIR COMPACT NO.24 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE .22; 2.2 g/11g; g/11g N 20181231 43419-036_3f9d14b8-25cf-442b-baff-466d1ba03b9f 43419-036 HUMAN OTC DRUG SULWHASOO EVENFAIR COMPACT NO.26 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE .22; 2.2 g/11g; g/11g N 20181231 43419-051_70ff9f97-7e2f-4b05-9840-f974d2191231 43419-051 HUMAN OTC DRUG SULWHASOO PERFECTING CUSHION NO.21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE SPONGE TOPICAL 20150902 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-052_70ff9f97-7e2f-4b05-9840-f974d2191231 43419-052 HUMAN OTC DRUG SULWHASOO PERFECTING CUSHION NO.23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE SPONGE TOPICAL 20150902 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-053_70ff9f97-7e2f-4b05-9840-f974d2191231 43419-053 HUMAN OTC DRUG SULWHASOO PERFECTING CUSHION NO.25 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE SPONGE TOPICAL 20150902 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-054_e35d7063-0d3b-4a23-ab26-92d5a104602d 43419-054 HUMAN OTC DRUG Sulwhasoo PERPECTING CUSHION BRIGHTENING NO.11 PALE PINK OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160411 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-055_e35d7063-0d3b-4a23-ab26-92d5a104602d 43419-055 HUMAN OTC DRUG Sulwhasoo PERPECTING CUSHION BRIGHTENING NO.13 LIGHT PINK OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160411 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-056_e35d7063-0d3b-4a23-ab26-92d5a104602d 43419-056 HUMAN OTC DRUG Sulwhasoo PERPECTING CUSHION BRIGHTENING NO.17 LIGHT BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160411 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-057_e35d7063-0d3b-4a23-ab26-92d5a104602d 43419-057 HUMAN OTC DRUG Sulwhasoo PERPECTING CUSHION BRIGHTENING NO.21 MEDIUM PINK OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160411 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-058_e35d7063-0d3b-4a23-ab26-92d5a104602d 43419-058 HUMAN OTC DRUG Sulwhasoo PERPECTING CUSHION BRIGHTENING NO.23 MEDIUM BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160411 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-059_e35d7063-0d3b-4a23-ab26-92d5a104602d 43419-059 HUMAN OTC DRUG Sulwhasoo PERPECTING CUSHION BRIGHTENING NO.25 DEEP BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160411 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-060_e35d7063-0d3b-4a23-ab26-92d5a104602d 43419-060 HUMAN OTC DRUG Sulwhasoo PERPECTING CUSHION BRIGHTENING NO.33 DARK BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160411 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-061_7eb02fb7-c1d0-475d-9cd4-82e34c1873ca 43419-061 HUMAN OTC DRUG Sulwhasoo PERFECTING CUSHION NO.11 PALE PINK OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160526 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-062_7eb02fb7-c1d0-475d-9cd4-82e34c1873ca 43419-062 HUMAN OTC DRUG Sulwhasoo PERFECTING CUSHION NO.13 LIGHT PINK OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160526 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-063_7eb02fb7-c1d0-475d-9cd4-82e34c1873ca 43419-063 HUMAN OTC DRUG Sulwhasoo PERFECTING CUSHION NO.21 MEDIUM PINK OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160526 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-064_7eb02fb7-c1d0-475d-9cd4-82e34c1873ca 43419-064 HUMAN OTC DRUG Sulwhasoo PERFECTING CUSHION NO.23 MEDIUM BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160526 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-065_7eb02fb7-c1d0-475d-9cd4-82e34c1873ca 43419-065 HUMAN OTC DRUG Sulwhasoo PERFECTING CUSHION NO.25 DEEP BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160526 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-066_7eb02fb7-c1d0-475d-9cd4-82e34c1873ca 43419-066 HUMAN OTC DRUG Sulwhasoo PERFECTING CUSHION NO.33 DARK BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20160526 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-067_e0b22b5b-1de5-4889-af55-cf6915c7f624 43419-067 HUMAN OTC DRUG SULWHASOO PERFECTING CUSHION INTENSE NO.11 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161110 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-068_e0b22b5b-1de5-4889-af55-cf6915c7f624 43419-068 HUMAN OTC DRUG SULWHASOO PERFECTING CUSHION INTENSE NO.13 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161110 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-069_e0b22b5b-1de5-4889-af55-cf6915c7f624 43419-069 HUMAN OTC DRUG SULWHASOO PERFECTING CUSHION INTENSE NO.17 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161110 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-070_e0b22b5b-1de5-4889-af55-cf6915c7f624 43419-070 HUMAN OTC DRUG SULWHASOO PERFECTING CUSHION INTENSE NO.21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161110 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-071_e0b22b5b-1de5-4889-af55-cf6915c7f624 43419-071 HUMAN OTC DRUG SULWHASOO PERFECTING CUSHION INTENSE NO.23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161110 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-072_e0b22b5b-1de5-4889-af55-cf6915c7f624 43419-072 HUMAN OTC DRUG SULWHASOO PERFECTING CUSHION INTENSE NO.25 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161110 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-073_e0b22b5b-1de5-4889-af55-cf6915c7f624 43419-073 HUMAN OTC DRUG SULWHASOO PERFECTING CUSHION INTENSE NO.33 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161110 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-301_f4201a49-ddb2-4ff8-a113-a26156c4c029 43419-301 HUMAN OTC DRUG IOPE RETIGEN ESSENCE DUAL CONCEALER OCTINOXATE and TITANIUM DIOXIDE KIT 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC N 20181231 43419-302_9e65df95-5e66-463a-ac85-0dcd1fab6b05 43419-302 HUMAN OTC DRUG IOPE RETIGEN GLOW COVER CAKE NO.21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .7; .3486; .2744 g/14g; g/14g; g/14g N 20181231 43419-303_9e65df95-5e66-463a-ac85-0dcd1fab6b05 43419-303 HUMAN OTC DRUG IOPE RETIGEN GLOW COVER CAKE NO.23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .7; .3486; .2744 g/14g; g/14g; g/14g N 20181231 43419-304_5c265840-4e76-4bd7-9d3b-bdbc7f428255 43419-304 HUMAN OTC DRUG IOPE RETIGEN MOISTURE BASE NATURAL YELLOW OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.45; .581; .686 g/35mL; g/35mL; g/35mL N 20181231 43419-305_5c265840-4e76-4bd7-9d3b-bdbc7f428255 43419-305 HUMAN OTC DRUG IOPE RETIGEN MOISTURE BASE NATURAL GREEN OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.45; .581; .686 g/35mL; g/35mL; g/35mL N 20181231 43419-306_6e77ad66-0751-436d-bf30-bafa7749d22c 43419-306 HUMAN OTC DRUG IOPE RETIGEN LUMINOUS BASE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.45; .581; .686 g/35mL; g/35mL; g/35mL N 20181231 43419-307_b00ed4ca-3f94-40c6-8d5c-1566afa6e5f1 43419-307 HUMAN OTC DRUG IOPE RETIGEN MOISTURE FOUNDATION NO.17 SPF22 PA PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .343 g/35mL; g/35mL; g/35mL N 20181231 43419-308_b00ed4ca-3f94-40c6-8d5c-1566afa6e5f1 43419-308 HUMAN OTC DRUG IOPE RETIGEN MOISTURE FOUNDATION NO.21 SPF22 PA PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .343 g/35mL; g/35mL; g/35mL N 20181231 43419-309_b00ed4ca-3f94-40c6-8d5c-1566afa6e5f1 43419-309 HUMAN OTC DRUG IOPE RETIGEN MOISTURE FOUNDATION NO.23 SPF22 PA PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .343 g/35mL; g/35mL; g/35mL N 20181231 43419-310_09c83fd7-f2d9-4fa6-83f4-89c8384c3df0 43419-310 HUMAN OTC DRUG AMOREPACIFIC NATURAL PROTECTOR OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .07; .19; .00025 mg/mL; mg/mL; mg/mL N 20181231 43419-311_f3c9d5d7-2707-499a-a337-86d6a55b381c 43419-311 HUMAN OTC DRUG IOPE RETIGEN MOISTURE TWIN CAKE NO.21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .84; .868; .4116 g/14g; g/14g; g/14g N 20181231 43419-312_f3c9d5d7-2707-499a-a337-86d6a55b381c 43419-312 HUMAN OTC DRUG IOPE RETIGEN MOISTURE TWIN CAKE NO.23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .84; .868; .4116 g/14g; g/14g; g/14g N 20181231 43419-313_f3c9d5d7-2707-499a-a337-86d6a55b381c 43419-313 HUMAN OTC DRUG IOPE RETIGEN MOISTURE TWIN CAKE NO.17 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .84; .868; .4116 g/14g; g/14g; g/14g N 20181231 43419-314_0323917f-ea6f-435b-af30-a19958aea323 43419-314 HUMAN OTC DRUG IOPE RETIGEN SMOOTHING PACT NO.1 SPF25 PA PLUS PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .84; .86912; .4116 g/14g; g/14g; g/14g N 20181231 43419-315_0323917f-ea6f-435b-af30-a19958aea323 43419-315 HUMAN OTC DRUG IOPE RETIGEN SMOOTHING PACT NO.2 SPF25 PA PLUS PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .84; .86912; .4116 g/14g; g/14g; g/14g N 20181231 43419-316_43eebed4-0cc6-44e1-a90a-9a3d64310c86 43419-316 HUMAN OTC DRUG IOPE AIR CUSHION XP COVER LIGHT VANILLA OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-317_2d10384f-e6ff-4c89-821d-e1bfa4ea47a4 43419-317 HUMAN OTC DRUG IOPE AIR CUSHION XP MATTE LIGHT VANILLA OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-318_2d10384f-e6ff-4c89-821d-e1bfa4ea47a4 43419-318 HUMAN OTC DRUG IOPE AIR CUSHION XP MATTE VANILLA OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-319_2d10384f-e6ff-4c89-821d-e1bfa4ea47a4 43419-319 HUMAN OTC DRUG IOPE AIR CUSHION XP MATTE BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-320_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-320 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 100 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL N 20181231 43419-321_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-321 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 102 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL N 20181231 43419-322_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-322 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 104 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL N 20181231 43419-323_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-323 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 106 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL N 20181231 43419-324_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-324 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 200 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL N 20181231 43419-325_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-325 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 202 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL N 20181231 43419-326_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-326 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 204 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL N 20181231 43419-327_1dd3c170-59af-4dc4-95c7-ecffbea0e784 43419-327 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE SKIN RENEWAL NO. 206 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0098; .1014 mg/mL; mg/mL; mg/mL N 20181231 43419-328_444e21ea-4ae1-426f-a77f-31bfd5735897 43419-328 HUMAN OTC DRUG IOPE AIR CUSHION XP INTENSE COVER VANILLA OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-329_444e21ea-4ae1-426f-a77f-31bfd5735897 43419-329 HUMAN OTC DRUG IOPE AIR CUSHION XP INTENSE COVER BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-330_f3df54e7-44b5-403a-ac57-a7d2030fc009 43419-330 HUMAN OTC DRUG IOPE BRIGHTGEN OXYBENZONE, OCTINOXATE, OCTISALATE, HOMOSALATE, OCTOCRYLENE, and TITANIUM DIOXIDE CREAM TOPICAL 20120824 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OXYBENZONE; OCTINOXATE; OCTISALATE; HOMOSALATE; OCTOCRYLENE; TITANIUM DIOXIDE 2.7; 4.2; 2.7; 3; 3; 3.12 g/60mL; g/60mL; g/60mL; g/60mL; g/60mL; g/60mL N 20181231 43419-331_4077f065-58f9-45dc-9948-08d312b807fc 43419-331 HUMAN OTC DRUG IOPE AIR CUSHION SHEER 23W OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-339_0028cf3c-35f0-42c6-abca-1a6988527598 43419-339 HUMAN OTC DRUG IOPE B.B. SPF20/PA plus Octinoxate and TITANIUM DIOXIDE CREAM TOPICAL 20100801 OTC MONOGRAPH FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2; 1.2 mL/40mL; mL/40mL N 20181231 43419-340_edbcf755-9d78-4a14-a1c7-98ed41b5f9b4 43419-340 HUMAN OTC DRUG IOPE B.B BB OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120919 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2; .996 g/40mL; g/40mL N 20181231 43419-350_1ba09a09-268e-44db-8322-95d26e974e52 43419-350 HUMAN OTC DRUG IOPE UV Defense Sun Protector SPF 50plus AVOBENZONE, OCTISALATE, HOMOSALATE, and OCTOCRYLENE CREAM TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 1.8; 2.7; 5.4; 5.4 g/60mL; g/60mL; g/60mL; g/60mL N 20181231 43419-351_54cef85b-90e2-4cfd-81bf-6ca4ebbbd028 43419-351 HUMAN OTC DRUG IOPE CC no. 1 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .686 g/35mL; g/35mL; g/35mL N 20181231 43419-352_54cef85b-90e2-4cfd-81bf-6ca4ebbbd028 43419-352 HUMAN OTC DRUG IOPE CC no. 2 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .686 g/35mL; g/35mL; g/35mL N 20181231 43419-353_d0b27b5a-417c-4c7b-be2a-428948a5e4dd 43419-353 HUMAN OTC DRUG IOPE Air Cushion Sunblock EX OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20100801 OTC MONOGRAPH FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.25; 2.94 g/30g; g/30g; g/30g N 20181231 43419-354_537432ef-b52d-4770-955d-5c10a3b0099d 43419-354 HUMAN OTC DRUG IOPE S.S. CONDITIONING COLOR BASE No.40 SPF22 PA PLUS Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0439; .0098 mL/mL; mL/mL; mL/mL N 20181231 43419-355_537432ef-b52d-4770-955d-5c10a3b0099d 43419-355 HUMAN OTC DRUG IOPE S.S. CONDITIONING COLOR BASE No.60 SPF22 PA PLUS Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0439; .0098 mL/mL; mL/mL; mL/mL N 20181231 43419-356_896bd2e2-e57c-4ed0-9d82-396a7e4e3cd1 43419-356 HUMAN OTC DRUG IOPE SS CONDITIONING FOUNDATION NO.13 SPF22 PA PLUS Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .03; .01 mL/mL; mL/mL; mL/mL N 20181231 43419-357_896bd2e2-e57c-4ed0-9d82-396a7e4e3cd1 43419-357 HUMAN OTC DRUG IOPE SS CONDITIONING FOUNDATION NO.21 SPF22 PA PLUS Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .03; .01 mL/mL; mL/mL; mL/mL N 20181231 43419-358_896bd2e2-e57c-4ed0-9d82-396a7e4e3cd1 43419-358 HUMAN OTC DRUG IOPE SS CONDITIONING FOUNDATION NO.23 SPF22 PA PLUS Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .03; .01 mL/mL; mL/mL; mL/mL N 20181231 43419-359_896bd2e2-e57c-4ed0-9d82-396a7e4e3cd1 43419-359 HUMAN OTC DRUG IOPE SS CONDITIONING FOUNDATION NO.31 SPF22 PA PLUS Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .03; .01 mL/mL; mL/mL; mL/mL N 20181231 43419-360_0318c320-9a6c-4422-9b09-9d8308342631 43419-360 HUMAN OTC DRUG IOPE SS CONDITIONING TWINCAKE NO.13 SPF25 PA PLUS PLUS OCTINOXATE and ZINC OXIDE POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; ZINC OXIDE .06; .03 g/g; g/g N 20181231 43419-361_0318c320-9a6c-4422-9b09-9d8308342631 43419-361 HUMAN OTC DRUG IOPE SS CONDITIONING TWINCAKE NO.21 SPF25 PA PLUS PLUS OCTINOXATE and ZINC OXIDE POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; ZINC OXIDE .06; .03 g/g; g/g N 20181231 43419-362_0318c320-9a6c-4422-9b09-9d8308342631 43419-362 HUMAN OTC DRUG IOPE SS CONDITIONING TWINCAKE NO.23 SPF25 PA PLUS PLUS OCTINOXATE and ZINC OXIDE POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; ZINC OXIDE .06; .03 g/g; g/g N 20181231 43419-363_0318c320-9a6c-4422-9b09-9d8308342631 43419-363 HUMAN OTC DRUG IOPE SS CONDITIONING TWINCAKE NO.31 SPF25 PA PLUS PLUS OCTINOXATE and ZINC OXIDE POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; ZINC OXIDE .06; .03 g/g; g/g N 20181231 43419-365_0a75edf9-80fe-40ca-87ef-6e40784a15eb 43419-365 HUMAN OTC DRUG IOPE MEN UV DEFENSE SUN PROTECTOR AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE LOTION TOPICAL 20161114 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.25; 4.5; 2.25; 4.5 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 43419-366_8b347515-600e-46fc-ab9e-f792853dac82 43419-366 HUMAN OTC DRUG IOPE AIR CUSHION MATTE LONGWEAR C13 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-367_9158dfc4-b723-4815-a56f-a6be47fb8909 43419-367 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST B.B OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; .8715; .686 mL/35mL; mL/35mL; mL/35mL E 20171231 43419-368_8b347515-600e-46fc-ab9e-f792853dac82 43419-368 HUMAN OTC DRUG IOPE AIR CUSHION MATTE LONGWEAR N23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-369_8b347515-600e-46fc-ab9e-f792853dac82 43419-369 HUMAN OTC DRUG IOPE AIR CUSHION MATTE LONGWEAR W21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-370_04641e32-dc2b-4345-8e1d-21bf4b36fd44 43419-370 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST BASE TITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE LOTION TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .8715; 1.75; .343 g/35mL; g/35mL; g/35mL N 20181231 43419-371_9dc3748c-3c49-4ebe-9ad7-b29dabdeeb3f 43419-371 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST FOUNDATION NO. 21 SPF12 PA PLUS TITANIUM DIOXIDE and OCTINOXATE LOTION TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; OCTINOXATE .287; 1.75 g/35mL; g/35mL E 20171231 43419-372_9dc3748c-3c49-4ebe-9ad7-b29dabdeeb3f 43419-372 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST FOUNDATION NO. 23 SPF12 PA PLUS TITANIUM DIOXIDE and OCTINOXATE LOTION TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; OCTINOXATE .287; 1.75 g/35mL; g/35mL E 20171231 43419-373_45279514-2e53-43be-b9c0-96dea36c8140 43419-373 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST TWIN PACT NO. 21 SPF25 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, AND ZINC OXIDE POWDER TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.08; 1.11744; .5292 g/18g; g/18g; g/18g N 20181231 43419-374_45279514-2e53-43be-b9c0-96dea36c8140 43419-374 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST TWIN PACT NO. 23 SPF25 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, AND ZINC OXIDE POWDER TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.08; 1.11744; .5292 g/18g; g/18g; g/18g N 20181231 43419-375_65958948-8e63-4ca5-bfbb-9c0297680e37 43419-375 HUMAN OTC DRUG IOPE Perfect Skin Base OCTINOXATE LOTION TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 2275 mg/35mL N 20181231 43419-376_4077f065-58f9-45dc-9948-08d312b807fc 43419-376 HUMAN OTC DRUG IOPE AIR CUSHION SHEER 13C OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-377_4077f065-58f9-45dc-9948-08d312b807fc 43419-377 HUMAN OTC DRUG IOPE AIR CUSHION SHEER 21N OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-378_4077f065-58f9-45dc-9948-08d312b807fc 43419-378 HUMAN OTC DRUG IOPE AIR CUSHION SHEER 21W OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-379_4077f065-58f9-45dc-9948-08d312b807fc 43419-379 HUMAN OTC DRUG IOPE AIR CUSHION SHEER 23N OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-380_4abd5f7b-2c87-4d1e-a1f2-83a02cee5574 43419-380 HUMAN OTC DRUG IOPE AIR CUSHION XP OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20130814 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-381_4abd5f7b-2c87-4d1e-a1f2-83a02cee5574 43419-381 HUMAN OTC DRUG IOPE AIR CUSHION XP OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20130814 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-382_9adc493e-5e87-4502-b10a-4491d37f4a6a 43419-382 HUMAN OTC DRUG IOPE AIR CUSHION XP COVER VANILLA BROAD SPECTRUM SPF50PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20130814 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-383_9adc493e-5e87-4502-b10a-4491d37f4a6a 43419-383 HUMAN OTC DRUG IOPE AIR CUSHION XP COVER BEIGE BROAD SPECTRUM SPF50PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20130814 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-384_d286e618-8b72-4491-9966-6473022ea291 43419-384 HUMAN OTC DRUG IOPE AIR CUSHION XP NATURAL 31 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20130612 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-385_bce1d73e-46f7-4035-8199-4e982834e95a 43419-385 HUMAN OTC DRUG IOPE Air Cushion Blusher no 1 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141027 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .63; .1494; .1764 g/9g; g/9g; g/9g N 20181231 43419-386_bce1d73e-46f7-4035-8199-4e982834e95a 43419-386 HUMAN OTC DRUG IOPE Air Cushion Blusher no 2 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141027 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .63; .1494; .1764 g/9g; g/9g; g/9g N 20181231 43419-387_67cbbefe-e5e1-4d44-a7b4-0414f9c77bea 43419-387 HUMAN OTC DRUG IOPE PERFECT SKIN COVER CAKE 23 NATURAL BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20150512 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .7; .3486; .2744 g/14g; g/14g; g/14g N 20181231 43419-388_67cbbefe-e5e1-4d44-a7b4-0414f9c77bea 43419-388 HUMAN OTC DRUG IOPE PERFECT SKIN COVER CAKE 21 LIGHT BEIGE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20150512 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .7; .3486; .2744 g/14g; g/14g; g/14g N 20181231 43419-389_55d6a1cd-df06-4ea7-bf65-8e954274ca7e 43419-389 HUMAN OTC DRUG IOPE AIR CUSHION FLAWLESS 21N OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-390_55d6a1cd-df06-4ea7-bf65-8e954274ca7e 43419-390 HUMAN OTC DRUG IOPE AIR CUSHION FLAWLESS 21W OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-391_55d6a1cd-df06-4ea7-bf65-8e954274ca7e 43419-391 HUMAN OTC DRUG IOPE AIR CUSHION FLAWLESS 23N OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-392_55d6a1cd-df06-4ea7-bf65-8e954274ca7e 43419-392 HUMAN OTC DRUG IOPE AIR CUSHION FLAWLESS 23W OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-393_55d6a1cd-df06-4ea7-bf65-8e954274ca7e 43419-393 HUMAN OTC DRUG IOPE AIR CUSHION FLAWLESS 13C OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-394_b4f8393b-cdd9-4a70-91a1-e2961ead2933 43419-394 HUMAN OTC DRUG IOPE AIR CUSHION PERFECTION C13 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-395_b4f8393b-cdd9-4a70-91a1-e2961ead2933 43419-395 HUMAN OTC DRUG IOPE AIR CUSHION PERFECTION N21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-396_b4f8393b-cdd9-4a70-91a1-e2961ead2933 43419-396 HUMAN OTC DRUG IOPE AIR CUSHION PERFECTION N23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-397_b4f8393b-cdd9-4a70-91a1-e2961ead2933 43419-397 HUMAN OTC DRUG IOPE AIR CUSHION PERFECTION W21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-398_ffedcffa-aac5-463c-b490-16343b139dc8 43419-398 HUMAN OTC DRUG IOPE MILD CLINIC SUN PROTECTOR TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20110516 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; ZINC OXIDE 2.22; 4.53 mL/60mL; mL/60mL N 20181231 43419-399_b4f8393b-cdd9-4a70-91a1-e2961ead2933 43419-399 HUMAN OTC DRUG IOPE AIR CUSHION PERFECTION W23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-401_8b347515-600e-46fc-ab9e-f792853dac82 43419-401 HUMAN OTC DRUG IOPE AIR CUSHION MATTE LONGWEAR W23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-402_8b347515-600e-46fc-ab9e-f792853dac82 43419-402 HUMAN OTC DRUG IOPE AIR CUSHION MATTE LONGWEAR N21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 4.521; .588 g/30g; g/30g; g/30g N 20181231 43419-403_d7b1c0c3-0ae6-46cd-908b-74a482d28638 43419-403 HUMAN OTC DRUG IOPE AIR CUSHION Cover 13 Ivory ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-404_5c6ef400-9483-435c-bdd1-93d8f9fd4dbb 43419-404 HUMAN OTC DRUG IOPE AIR CUSHION Cover 21 Vanilla ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20180110 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20191231 43419-404_d7b1c0c3-0ae6-46cd-908b-74a482d28638 43419-404 HUMAN OTC DRUG IOPE AIR CUSHION Cover 21 Vanilla ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20191231 43419-405_5c6ef400-9483-435c-bdd1-93d8f9fd4dbb 43419-405 HUMAN OTC DRUG IOPE AIR CUSHION Cover 23 Beige ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20180110 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20191231 43419-405_d7b1c0c3-0ae6-46cd-908b-74a482d28638 43419-405 HUMAN OTC DRUG IOPE AIR CUSHION Cover 23 Beige ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20191231 43419-406_9ecc9f91-dda7-4d7b-85ec-4675e1dd3e65 43419-406 HUMAN OTC DRUG IOPE AIR CUSHION Natural 13 Ivory ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-407_9ecc9f91-dda7-4d7b-85ec-4675e1dd3e65 43419-407 HUMAN OTC DRUG IOPE AIR CUSHION Natural 21 Vanilla ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-408_9ecc9f91-dda7-4d7b-85ec-4675e1dd3e65 43419-408 HUMAN OTC DRUG IOPE AIR CUSHION Natural 23 Beige ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-409_1134e413-adcd-405b-b0a6-e64102b0ccc4 43419-409 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST FOUNDATION No.21 OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 1.75; .35 g/35mL; g/35mL N 20181231 43419-410_1134e413-adcd-405b-b0a6-e64102b0ccc4 43419-410 HUMAN OTC DRUG IOPE SUPER VITAL EXTRA MOIST FOUNDATION No.23 OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 1.75; .35 g/35mL; g/35mL N 20181231 43419-411_c0a10645-99e9-4bc2-aad1-63c85e224f1d 43419-411 HUMAN OTC DRUG IOPE Air Cushion Intense Cover 13 ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC CORPORATION ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.47; 1.05; .6225 g/15g; g/15g; g/15g N 20191231 43419-412_22b926e8-f59b-4843-ae03-487900f81a94 43419-412 HUMAN OTC DRUG IOPE Air Cushion Intense Cover 21 ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC CORPORATION ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.47; 1.05; .6225 g/15g; g/15g; g/15g N 20191231 43419-412_c0a10645-99e9-4bc2-aad1-63c85e224f1d 43419-412 HUMAN OTC DRUG IOPE Air Cushion Intense Cover 21 ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC CORPORATION ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.47; 1.05; .6225 g/15g; g/15g; g/15g N 20191231 43419-413_22b926e8-f59b-4843-ae03-487900f81a94 43419-413 HUMAN OTC DRUG IOPE Air Cushion Intense Cover 23 ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC CORPORATION ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.47; 1.05; .6225 g/15g; g/15g; g/15g N 20191231 43419-413_c0a10645-99e9-4bc2-aad1-63c85e224f1d 43419-413 HUMAN OTC DRUG IOPE Air Cushion Intense Cover 23 ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC CORPORATION ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.47; 1.05; .6225 g/15g; g/15g; g/15g N 20191231 43419-501_248a1fcf-3edc-41ae-8cef-1872cd2c427b 43419-501 HUMAN OTC DRUG AMOREPACIFIC MOISTURE BOUND NO. 102 OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2.5; 1.05 mL/50mL; mL/50mL E 20171231 43419-502_248a1fcf-3edc-41ae-8cef-1872cd2c427b 43419-502 HUMAN OTC DRUG AMOREPACIFIC MOISTURE BOUND NO. 104 OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2.5; 1.05 mL/50mL; mL/50mL E 20171231 43419-503_248a1fcf-3edc-41ae-8cef-1872cd2c427b 43419-503 HUMAN OTC DRUG AMOREPACIFIC MOISTURE BOUND NO. 106 OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2.5; 1.05 mL/50mL; mL/50mL E 20171231 43419-504_248a1fcf-3edc-41ae-8cef-1872cd2c427b 43419-504 HUMAN OTC DRUG AMOREPACIFIC MOISTURE BOUND NO. 204 OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2.5; 1.05 mL/50mL; mL/50mL E 20171231 43419-505_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-505 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE NO. 102 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294 mL/30mL; mL/30mL; mL/30mL E 20171231 43419-506_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-506 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE NO. 104 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294 mL/30mL; mL/30mL; mL/30mL E 20171231 43419-507_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-507 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE NO. 106 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294 mL/30mL; mL/30mL; mL/30mL E 20171231 43419-508_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-508 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE NO. 202 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294 mL/30mL; mL/30mL; mL/30mL E 20171231 43419-509_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-509 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE NO. 204 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294 mL/30mL; mL/30mL; mL/30mL E 20171231 43419-510_a4a3b32c-42fa-472f-80a7-03e0c15b3503 43419-510 HUMAN OTC DRUG AMOREPACIFIC TIME RESPONSE NO. 206 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.245; .294 mL/30mL; mL/30mL; mL/30mL E 20171231 43419-511_609d1a43-dfc9-4816-aca0-596f3c623e6c 43419-511 HUMAN OTC DRUG AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20121205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-512_609d1a43-dfc9-4816-aca0-596f3c623e6c 43419-512 HUMAN OTC DRUG AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.106 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20121205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-513_609d1a43-dfc9-4816-aca0-596f3c623e6c 43419-513 HUMAN OTC DRUG AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.204 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20121205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-514_609d1a43-dfc9-4816-aca0-596f3c623e6c 43419-514 HUMAN OTC DRUG AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.208 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20121205 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-515_bbc224e7-d0e5-417b-ae97-844cbbb591cb 43419-515 HUMAN OTC DRUG AMOREPACIFIC FUTURE RESPONSE Age Defense SPF30 OCTINOXATE, OCTISALATE, OCTOCRYLENE, and TITANIUM DIOXIDE CREAM TOPICAL 20130125 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 3.6505; 2.34675; 4.172; 2.2946 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 43419-516_6ab34ca6-e83f-4247-bbed-ed10fe2a8694 43419-516 HUMAN OTC DRUG AMOREPACIFIC FUTURE RESPONSE AGE DEFENSE DUAL EYE WITH SPF 25 SUNSCREEN OCTINOXATE, OCTISALATE, OCTOCRYLENE, and TITANIUM DIOXIDE KIT 20140108 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC N 20181231 43419-520_5d32382a-9a4b-4a34-ad58-8cb802c1f8aa 43419-520 HUMAN OTC DRUG Amorepacific Resort Collection Sun Protection Cushion OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20150206 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-521_4dd90363-d0d2-4f08-be64-5c9f6cb81845 43419-521 HUMAN OTC DRUG Amorepacific Resort Collection Sun Protection HOMOSALATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE STICK TOPICAL 20150213 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE .63; .63; .315; .21 g/7g; g/7g; g/7g; g/7g N 20181231 43419-522_9ad6d7e3-7f98-445b-b292-e84feb8f4b3e 43419-522 HUMAN OTC DRUG Amorepacific Resort Collection Sun Protection Mist HOMOSALATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE SPRAY TOPICAL 20150213 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 28000; 18000; 9000; 6000 mg/200mL; mg/200mL; mg/200mL; mg/200mL N 20181231 43419-523_bf1a6504-6472-4254-8c17-3b44ae2e85e5 43419-523 HUMAN OTC DRUG Amorepacific Age Correcting Foundation Cushion 102 OCTINOXATE LOTION TOPICAL 20151019 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE .975 g/15g N 20181231 43419-524_bf1a6504-6472-4254-8c17-3b44ae2e85e5 43419-524 HUMAN OTC DRUG Amorepacific Age Correcting Foundation Cushion 104 OCTINOXATE LOTION TOPICAL 20151019 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE .975 g/15g N 20181231 43419-525_bf1a6504-6472-4254-8c17-3b44ae2e85e5 43419-525 HUMAN OTC DRUG Amorepacific Age Correcting Foundation Cushion 106 OCTINOXATE LOTION TOPICAL 20151019 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE .975 g/15g N 20181231 43419-526_bf1a6504-6472-4254-8c17-3b44ae2e85e5 43419-526 HUMAN OTC DRUG Amorepacific Age Correcting Foundation Cushion 204 OCTINOXATE LOTION TOPICAL 20151019 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE .975 g/15g N 20181231 43419-527_bf1a6504-6472-4254-8c17-3b44ae2e85e5 43419-527 HUMAN OTC DRUG Amorepacific Age Correcting Foundation Cushion 208 OCTINOXATE LOTION TOPICAL 20151019 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE .975 g/15g N 20181231 43419-528_a01ba17f-a513-47fb-81f7-368d5403597a 43419-528 HUMAN OTC DRUG AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102 ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-545_8c8a8d80-82c2-4f7b-9274-d07c8d71f73f 43419-545 HUMAN OTC DRUG Mamonde Total Mineral Moisture BB SPF20 PA plus OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE 2.5; 1.5 mL/50mL; mL/50mL N 20181231 43419-546_2d9d3750-5164-4eb8-b8a7-fa8b4735fb5d 43419-546 HUMAN OTC DRUG MAMONDE BRIGHTENING PACT 10HR N21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .032; .055; .02 g/g; g/g; g/g N 20181231 43419-547_2d9d3750-5164-4eb8-b8a7-fa8b4735fb5d 43419-547 HUMAN OTC DRUG MAMONDE BRIGHTENING PACT 10HR N23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .032; .055; .02 g/g; g/g; g/g N 20181231 43419-580_238d9db0-760f-4acb-8e1a-13d014a1f256 43419-580 HUMAN OTC DRUG Amorepacific Natural Protector AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1500; 5400; 2700; 5400 mg/60mL; mg/60mL; mg/60mL; mg/60mL N 20181231 43419-601_7d50297e-1f7e-44be-ae57-ad2a7570c2f0 43419-601 HUMAN OTC DRUG ETUDE HOUSE Precious Mineral BB Bright Fit Natural Beige W13 TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part352 ETUDE HOUSE TITANIUM DIOXIDE; ZINC OXIDE 6.264; .864 g/60g; g/60g E 20171231 43419-602_7d50297e-1f7e-44be-ae57-ad2a7570c2f0 43419-602 HUMAN OTC DRUG ETUDE HOUSE Precious Mineral BB Bright Fit SPF 30 Honey Beige W24 TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part352 ETUDE HOUSE TITANIUM DIOXIDE; ZINC OXIDE 6.264; .864 g/60g; g/60g E 20171231 43419-701_7aa57ff1-7e9b-422a-b5ce-df8102506a03 43419-701 HUMAN OTC DRUG LANEIGE LIP TREATMENT SPF 17 No.1 OCTINOXATE STICK TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE .12 g/4g E 20171231 43419-702_7aa57ff1-7e9b-422a-b5ce-df8102506a03 43419-702 HUMAN OTC DRUG LANEIGE LIP TREATMENT SPF 17 No.2 OCTINOXATE STICK TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE .12 g/4g E 20171231 43419-703_7aa57ff1-7e9b-422a-b5ce-df8102506a03 43419-703 HUMAN OTC DRUG LANEIGE LIP TREATMENT SPF 17 No.3 OCTINOXATE STICK TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE .12 g/4g E 20171231 43419-704_ab48ca3d-966c-4e50-8173-ae335eb9c632 43419-704 HUMAN OTC DRUG LANEIGE BB Cushion Light OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-705_ab48ca3d-966c-4e50-8173-ae335eb9c632 43419-705 HUMAN OTC DRUG LANEIGE BB Cushion Medium OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-706_ab48ca3d-966c-4e50-8173-ae335eb9c632 43419-706 HUMAN OTC DRUG Laneige BB Cushion Dark OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-707_8e35813b-f397-47e6-b92f-f72b9bbf7777 43419-707 HUMAN OTC DRUG LANEIGE BB Cushion no.21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-708_8e35813b-f397-47e6-b92f-f72b9bbf7777 43419-708 HUMAN OTC DRUG LANEIGE BB Cushion no.23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-709_6d635814-5a57-48b0-9398-f9592b8bcabf 43419-709 HUMAN OTC DRUG LANEIGE Skin Veil Foundation EX No. 21N Natural Beige OCTINOXATE LOTION TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL N 20181231 43419-710_6d635814-5a57-48b0-9398-f9592b8bcabf 43419-710 HUMAN OTC DRUG LANEIGE Skin Veil Foundation EX No. 23 Sand Beige OCTINOXATE LOTION TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL N 20181231 43419-711_6d635814-5a57-48b0-9398-f9592b8bcabf 43419-711 HUMAN OTC DRUG LANEIGE Skin Veil Foundation EX No. 31 Brown Beige OCTINOXATE LOTION TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL N 20181231 43419-712_102d2cba-3484-4133-b6eb-bff324002d93 43419-712 HUMAN OTC DRUG LANEIGE SKIN VEIL BASE EX No.40 Light Purple OCTINOXATE LOTION TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL N 20181231 43419-713_102d2cba-3484-4133-b6eb-bff324002d93 43419-713 HUMAN OTC DRUG LANEIGE SKIN VEIL BASE EX No.60 Light Green OCTINOXATE LOTION TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 1.95 g/30mL N 20181231 43419-714_4536c1c6-d397-4a3b-8907-7d1b8da640d5 43419-714 HUMAN OTC DRUG Sulwhasoo Lumitouch Multi-Base No.1 Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.65; 2.94 mL/30mL; mL/30mL; mL/30mL N 20181231 43419-715_4536c1c6-d397-4a3b-8907-7d1b8da640d5 43419-715 HUMAN OTC DRUG Sulwhasoo Lumitouch Multi-Base No.2 Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.65; 2.94 mL/30mL; mL/30mL; mL/30mL N 20181231 43419-716_f4464483-1b9f-4b9a-ab2f-3001b26cf5b7 43419-716 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation SPF15, PA plus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part352 AMOREPACIFIC CO. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; 2.584; .2939 mL/30mL; mL/30mL; mL/30mL N 20181231 43419-717_b0cc649f-c625-4272-913c-705d779a99f5 43419-717 HUMAN OTC DRUG Sulwhasoo Lumitouch Base Makeup SPF15, PA plus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part352 AMOREPACIFIC CO. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .9; .82; .294 mL/30mL; mL/30mL; mL/30mL N 20181231 43419-718_0dff6226-0138-4049-b413-883588a5a13d 43419-718 HUMAN OTC DRUG Sulwhasoo Lumitouch Foundation SPF26, PA plus plus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part352 AMOREPACIFIC CO. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .56; 3.358; 1.371 g/14g; g/14g; g/14g N 20181231 43419-719_ccfe56ff-4382-4b3e-8fdb-3c9650473823 43419-719 HUMAN OTC DRUG Sulwhasoo Lumitouch Twincake SPF25, PA plus plus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20100901 OTC MONOGRAPH FINAL part352 AMOREPACIFIC CO. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .352; 1.533; .216 g/11g; g/11g; g/11g N 20181231 43419-721_27387f1a-989b-4ec5-bda3-ab8569f8b8c5 43419-721 HUMAN OTC DRUG Laneige Watery Cushion Concealer no. 1 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141021 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 50; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL N 20181231 43419-722_27387f1a-989b-4ec5-bda3-ab8569f8b8c5 43419-722 HUMAN OTC DRUG Laneige Watery Cushion Concealer no. 2 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141021 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 50; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL N 20181231 43419-723_27387f1a-989b-4ec5-bda3-ab8569f8b8c5 43419-723 HUMAN OTC DRUG Laneige Watery Cushion Concealer no. 3 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141021 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 50; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL N 20181231 43419-724_0ff8da51-47ac-464c-8c14-1431c19430f8 43419-724 HUMAN OTC DRUG Laneige Cushion Concealer Light OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 62.25; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL N 20181231 43419-725_3f060970-bb10-4520-bbed-6356213b79b4 43419-725 HUMAN OTC DRUG Laneige Cushion Concealer Medium OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 62.25; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL N 20181231 43419-726_f5464fd7-e784-45e3-b656-fccd4f6ff58d 43419-726 HUMAN OTC DRUG LANEIGE Forever Definite Compact Foundation No.1 TITANIUM DIOXIDE and ZINC OXIDE POWDER TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; ZINC OXIDE .8379; .2646 g/9g; g/9g E 20171231 43419-727_f5464fd7-e784-45e3-b656-fccd4f6ff58d 43419-727 HUMAN OTC DRUG LANEIGE Forever Definite Compact Foundation No.2 TITANIUM DIOXIDE and ZINC OXIDE POWDER TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; ZINC OXIDE .8379; .2646 g/9g; g/9g E 20171231 43419-728_f5464fd7-e784-45e3-b656-fccd4f6ff58d 43419-728 HUMAN OTC DRUG LANEIGE Forever Definite Compact Foundation No.3 TITANIUM DIOXIDE and ZINC OXIDE POWDER TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; ZINC OXIDE .8379; .2646 g/9g; g/9g E 20171231 43419-729_f5464fd7-e784-45e3-b656-fccd4f6ff58d 43419-729 HUMAN OTC DRUG LANEIGE Forever Definite Compact Foundation No.4 TITANIUM DIOXIDE and ZINC OXIDE POWDER TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; ZINC OXIDE .8379; .2646 g/9g; g/9g E 20171231 43419-730_c3bfec20-de78-4f51-b414-3e7f8a67b520 43419-730 HUMAN OTC DRUG LANEIGE Snow BB No.1 Brightening BB OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2.324; .784 g/40mL; g/40mL; g/40mL N 20181231 43419-731_c3bfec20-de78-4f51-b414-3e7f8a67b520 43419-731 HUMAN OTC DRUG LANEIGE Snow BB No.2 Natural BB OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.8; 2.324; .784 g/40mL; g/40mL; g/40mL N 20181231 43419-733_ab48ca3d-966c-4e50-8173-ae335eb9c632 43419-733 HUMAN OTC DRUG Laneige BB Cushion Medium Dark OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.05; .6225; 1.47 g/15g; g/15g; g/15g N 20181231 43419-734_862ca96d-2930-4757-8404-10f1967eeac3 43419-734 HUMAN OTC DRUG LANEIGE BB CUSHION FAIR OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-735_862ca96d-2930-4757-8404-10f1967eeac3 43419-735 HUMAN OTC DRUG LANEIGE BB CUSHION LIGHT MEDIUM OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.1; 1.245; 2.94 g/30g; g/30g; g/30g N 20181231 43419-736_84bdd223-7749-4581-bc6a-544dad260687 43419-736 HUMAN OTC DRUG LANEIGE CUSHION CONCEALER FAIR OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .125; .06225; .049 mg/2.5mL; mg/2.5mL; mg/2.5mL N 20181231 43419-737_84bdd223-7749-4581-bc6a-544dad260687 43419-737 HUMAN OTC DRUG LANEIGE CUSHION CONCEALER LIGHT MEDIUM OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .125; .06225; .049 mg/2.5mL; mg/2.5mL; mg/2.5mL N 20181231 43419-738_c4850757-8f66-4ec4-a34a-cc9da30e758d 43419-738 HUMAN OTC DRUG LANEIGE BB CUSHION PORE BLUR No.11 Porcelain ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-739_c4850757-8f66-4ec4-a34a-cc9da30e758d 43419-739 HUMAN OTC DRUG LANEIGE BB CUSHION PORE BLUR No.21 Beige ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-740_c4850757-8f66-4ec4-a34a-cc9da30e758d 43419-740 HUMAN OTC DRUG LANEIGE BB CUSHION PORE BLUR No.23 Sand ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-741_c4850757-8f66-4ec4-a34a-cc9da30e758d 43419-741 HUMAN OTC DRUG LANEIGE BB CUSHION PORE BLUR No.33 Cinnamon ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-742_c4850757-8f66-4ec4-a34a-cc9da30e758d 43419-742 HUMAN OTC DRUG LANEIGE BB CUSHION PORE BLUR No.35 Coffee ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-743_c4850757-8f66-4ec4-a34a-cc9da30e758d 43419-743 HUMAN OTC DRUG LANEIGE BB CUSHION PORE BLUR No.37 Cacao ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-744_a5fd9a8b-efdd-47a0-bc24-4c64abf84357 43419-744 HUMAN OTC DRUG LANEIGE MYSTIC VEIL FOUNDATION No. 21 Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.25; 1.70426; .49 mL/25mL; mL/25mL; mL/25mL N 20181231 43419-745_a5fd9a8b-efdd-47a0-bc24-4c64abf84357 43419-745 HUMAN OTC DRUG LANEIGE MYSTIC VEIL FOUNDATION No. 23 Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.25; 1.70426; .49 mL/25mL; mL/25mL; mL/25mL N 20181231 43419-746_392dd6e2-7407-4946-994d-a419737f9e14 43419-746 HUMAN OTC DRUG Laneige Sliding Pact EX snow crystal No.1 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; .74496; .3528 g/12g; g/12g; g/12g N 20181231 43419-747_392dd6e2-7407-4946-994d-a419737f9e14 43419-747 HUMAN OTC DRUG Laneige sliding pact EX snow crystal No.2 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; .74496; .3528 g/12g; g/12g; g/12g N 20181231 43419-748_392dd6e2-7407-4946-994d-a419737f9e14 43419-748 HUMAN OTC DRUG Laneige sliding pact EX snow crystal No.3 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; .74496; .3528 g/12g; g/12g; g/12g N 20181231 43419-749_392dd6e2-7407-4946-994d-a419737f9e14 43419-749 HUMAN OTC DRUG Laneige sliding pact EX snow crystal No.4 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; .74496; .3528 g/12g; g/12g; g/12g N 20181231 43419-750_392dd6e2-7407-4946-994d-a419737f9e14 43419-750 HUMAN OTC DRUG Laneige sliding pact EX snow crystal No.5 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20111221 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .72; .74496; .3528 g/12g; g/12g; g/12g N 20181231 43419-751_b4639999-7d69-4384-9d4c-9910cec57a44 43419-751 HUMAN OTC DRUG LANEIGE BB CUSHION HYDRA RADIANCE No.11 Porcelain ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-752_b4639999-7d69-4384-9d4c-9910cec57a44 43419-752 HUMAN OTC DRUG LANEIGE BB CUSHION HYDRA RADIANCE No.21 Beige ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-753_b4639999-7d69-4384-9d4c-9910cec57a44 43419-753 HUMAN OTC DRUG LANEIGE BB CUSHION HYDRA RADIANCE No.23 Sand ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-754_b4639999-7d69-4384-9d4c-9910cec57a44 43419-754 HUMAN OTC DRUG LANEIGE BB CUSHION HYDRA RADIANCE No.33 Cinnamon ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-755_b4639999-7d69-4384-9d4c-9910cec57a44 43419-755 HUMAN OTC DRUG LANEIGE BB CUSHION HYDRA RADIANCE No.35 Coffee ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-756_b4639999-7d69-4384-9d4c-9910cec57a44 43419-756 HUMAN OTC DRUG LANEIGE BB CUSHION HYDRA RADIANCE No.37 Cacao ZINC OXIDE, OCTINOXATE, and TITANIUM DIOXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.94; 2.1; 1.245 g/30g; g/30g; g/30g N 20181231 43419-757_891ed0f4-7093-496e-b695-cee83fa467dd 43419-757 HUMAN OTC DRUG LANEIGE CUSHION CONCEALER No.11 Rose Porcelain OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 62.25; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL N 20181231 43419-758_891ed0f4-7093-496e-b695-cee83fa467dd 43419-758 HUMAN OTC DRUG LANEIGE CUSHION CONCEALER No.13 Cool Ivory OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 62.25; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL N 20181231 43419-759_891ed0f4-7093-496e-b695-cee83fa467dd 43419-759 HUMAN OTC DRUG LANEIGE CUSHION CONCEALER No.21 Cool Beige OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 62.25; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL N 20181231 43419-760_891ed0f4-7093-496e-b695-cee83fa467dd 43419-760 HUMAN OTC DRUG LANEIGE CUSHION CONCEALER No.23 Sand OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 125; 62.25; 49 mg/2.5mL; mg/2.5mL; mg/2.5mL N 20181231 43419-765_cba8b903-850f-4160-a396-67c8cec8bc2d 43419-765 HUMAN OTC DRUG Laneige Triple Sunscreen AVOBENZONE, OCTISALATE, HOMOSALATE, and OCTOCRYLENE CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 1500; 2250; 4500; 4500 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 43419-776_4b12b5a7-53cf-4ae4-aa51-98974c9e6d74 43419-776 HUMAN OTC DRUG IOPE Perfect Skin Foundation no 21 OCTINOXATE LOTION TOPICAL 20150116 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 2275 mg/35mL N 20181231 43419-777_4b12b5a7-53cf-4ae4-aa51-98974c9e6d74 43419-777 HUMAN OTC DRUG IOPE Perfect Skin Foundation no 23 OCTINOXATE LOTION TOPICAL 20150116 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE 2275 mg/35mL N 20181231 43419-778_c0b2801d-2061-4bc0-83d3-0ddce2bb5ffc 43419-778 HUMAN OTC DRUG IOPE Perfect Skin 1 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE .7; 3.4475 g/35g; g/35g N 20181231 43419-779_c0b2801d-2061-4bc0-83d3-0ddce2bb5ffc 43419-779 HUMAN OTC DRUG IOPE Perfect Skin 2 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE .7; 3.4475 g/35g; g/35g N 20181231 43419-780_92744fb9-db5a-4d5a-a3b8-8a2c8be6f67f 43419-780 HUMAN OTC DRUG IOPE Perfect Skin Twin Pact no 21 TITANIUM DIOXIDE and ZINC OXIDE POWDER TOPICAL 20150120 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; ZINC OXIDE 1.1172; .3528 g/12g; g/12g N 20181231 43419-781_92744fb9-db5a-4d5a-a3b8-8a2c8be6f67f 43419-781 HUMAN OTC DRUG IOPE Perfect Skin Twin Pact no 23 TITANIUM DIOXIDE and ZINC OXIDE POWDER TOPICAL 20150120 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; ZINC OXIDE 1.1172; .3528 g/12g; g/12g N 20181231 43419-801_239f6a22-a845-4aad-a1a1-f34e1ba390cc 43419-801 HUMAN OTC DRUG Mamonde Total Moisture BB 01 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2; .996; .784 g/40mL; g/40mL; g/40mL N 20181231 43419-802_239f6a22-a845-4aad-a1a1-f34e1ba390cc 43419-802 HUMAN OTC DRUG Mamonde Total Moisture BB 02 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2; .996; .784 g/40mL; g/40mL; g/40mL N 20181231 43419-803_d696898b-3844-4c8b-8bac-07181178bb4a 43419-803 HUMAN OTC DRUG MAMONDE PACT BLOOMING 21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20130930 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .384; .51216; .2352 g/12g; g/12g; g/12g N 20181231 43419-804_d696898b-3844-4c8b-8bac-07181178bb4a 43419-804 HUMAN OTC DRUG MAMONDE PACT BLOOMING 23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER TOPICAL 20130930 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .384; .51216; .2352 g/12g; g/12g; g/12g N 20181231 43419-805_a22ff909-5627-49e8-aa1a-07c21d0f17c7 43419-805 HUMAN OTC DRUG MAMONDE Daily Sunscreen HOMOSALATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE LOTION TOPICAL 20170123 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 4.5; 4.5; 2.25; 1.25 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 43419-806_7719f5a8-860f-40ea-b23d-bd37d99e868d 43419-806 HUMAN OTC DRUG MAMONDE UV Fluid HOMOSALATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE LOTION TOPICAL 20170123 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 3.15; 3.15; 1.575; .875 g/35mL; g/35mL; g/35mL; g/35mL N 20181231 43419-807_4e56e6f2-56b3-47bc-8a97-c57367f24fb2 43419-807 HUMAN OTC DRUG Mamonde Brightening Cover Watery Cushion No. 11 Zinc Oxide, Octinoxate, and Titanium Dioxide LOTION TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC CORPORATION ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.47; 1.049; .6225 g/15g; g/15g; g/15g N 20181231 43419-808_4e56e6f2-56b3-47bc-8a97-c57367f24fb2 43419-808 HUMAN OTC DRUG Mamonde Brightening Cover Watery Cushion No. 21 Zinc Oxide, Octinoxate, and Titanium Dioxide LOTION TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC CORPORATION ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.47; 1.049; .6225 g/15g; g/15g; g/15g N 20181231 43419-809_4e56e6f2-56b3-47bc-8a97-c57367f24fb2 43419-809 HUMAN OTC DRUG Mamonde Brightening Cover Watery Cushion No. 23 Zinc Oxide, Octinoxate, and Titanium Dioxide LOTION TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC CORPORATION ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.47; 1.049; .6225 g/15g; g/15g; g/15g N 20181231 43419-810_4e56e6f2-56b3-47bc-8a97-c57367f24fb2 43419-810 HUMAN OTC DRUG Mamonde Brightening Cover Watery Cushion No. 33 Zinc Oxide, Octinoxate, and Titanium Dioxide LOTION TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC CORPORATION ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.47; 1.049; .6225 g/15g; g/15g; g/15g N 20181231 43419-811_725711cf-9695-425c-b6f1-e892bea63e00 43419-811 HUMAN OTC DRUG LANEIGE SunScreen Triple OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 58.1; 19.6 mg/mL; mg/mL; g/mL N 20181231 43419-812_4e56e6f2-56b3-47bc-8a97-c57367f24fb2 43419-812 HUMAN OTC DRUG Mamonde Brightening Cover Watery Cushion No. 35 Zinc Oxide, Octinoxate, and Titanium Dioxide LOTION TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC CORPORATION ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.47; 1.049; .6225 g/15g; g/15g; g/15g N 20181231 43419-813_4e56e6f2-56b3-47bc-8a97-c57367f24fb2 43419-813 HUMAN OTC DRUG Mamonde Brightening Cover Watery Cushion No. 37 Zinc Oxide, Octinoxate, and Titanium Dioxide LOTION TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC CORPORATION ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.47; 1.049; .6225 g/15g; g/15g; g/15g N 20181231 43419-850_2b702ef4-ae8f-4043-902d-70d6a91717f2 43419-850 HUMAN OTC DRUG LANEIGE SKIN VEIL BASE NO. 20 SPF 26 PA PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .037; .012 mg/mL; mg/mL; mg/mL N 20181231 43419-851_2b702ef4-ae8f-4043-902d-70d6a91717f2 43419-851 HUMAN OTC DRUG LANEIGE SKIN VEIL BASE NO. 40 SPF 26 PA PLUS OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .037; .012 mg/mL; mg/mL; mg/mL N 20181231 43419-852_7cb0ea13-db9b-4986-94dd-b086e2e5ee89 43419-852 HUMAN OTC DRUG LANEIGE SKIN VEIL BASE SPF 26 PA plus Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.11; .36 mL/30mL; mL/30mL; mL/30mL N 20181231 43419-853_9d982d2c-428c-49ef-a195-3816bfe252dc 43419-853 HUMAN OTC DRUG Laneige Skin Veil NO.21 SPF 26 PAplus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0955; .012 mg/mL; mg/mL; mg/mL N 20181231 43419-854_9d982d2c-428c-49ef-a195-3816bfe252dc 43419-854 HUMAN OTC DRUG Laneige Skin Veil NO.23 SPF 26 PAplus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0955; .012 mg/mL; mg/mL; mg/mL N 20181231 43419-855_9d982d2c-428c-49ef-a195-3816bfe252dc 43419-855 HUMAN OTC DRUG Laneige Skin Veil NO.31 SPF 26 PAplus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0955; .012 mg/mL; mg/mL; mg/mL N 20181231 43419-856_9d982d2c-428c-49ef-a195-3816bfe252dc 43419-856 HUMAN OTC DRUG Laneige Skin Veil NO.33 SPF 26 PAplus OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0955; .012 mg/mL; mg/mL; mg/mL N 20181231 43419-857_05ba4362-a6e2-4aca-858d-b691cfcb143a 43419-857 HUMAN OTC DRUG LANEIGE SNOW CRYSTAL No. 21 SPF22 PAplus Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0582; .0098 mg/mL; mg/mL; mg/mL N 20181231 43419-858_05ba4362-a6e2-4aca-858d-b691cfcb143a 43419-858 HUMAN OTC DRUG LANEIGE SNOW CRYSTAL No. 23 SPF22 PAplus Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0582; .0098 mg/mL; mg/mL; mg/mL N 20181231 43419-859_05ba4362-a6e2-4aca-858d-b691cfcb143a 43419-859 HUMAN OTC DRUG LANEIGE SNOW CRYSTAL No. 31 SPF22 PAplus Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0582; .0098 mg/mL; mg/mL; mg/mL N 20181231 43419-860_05ba4362-a6e2-4aca-858d-b691cfcb143a 43419-860 HUMAN OTC DRUG LANEIGE SNOW CRYSTAL No. 33 SPF22 PAplus Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .05; .0582; .0098 mg/mL; mg/mL; mg/mL N 20181231 43419-861_1b0a97ed-7a21-4bfb-97ae-dd640b276e9a 43419-861 HUMAN OTC DRUG Laneige UV TOTAL BASE Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .07; .084; .02 mg/mL; mg/mL; mg/mL N 20181231 43419-862_1b0a97ed-7a21-4bfb-97ae-dd640b276e9a 43419-862 HUMAN OTC DRUG Laneige UV TOTAL BASE Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .07; .084; .02 mg/mL; mg/mL; mg/mL N 20181231 43419-863_2a43db72-7e0f-4bf2-b9e4-81ef73a2f989 43419-863 HUMAN OTC DRUG LANEIGE SATIN FINISH TWIN PACT NO. 13 TITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .08; .06; .0294 mg/g; mg/g; mg/g N 20181231 43419-864_2a43db72-7e0f-4bf2-b9e4-81ef73a2f989 43419-864 HUMAN OTC DRUG LANEIGE SATIN FINISH TWIN PACT NO. 21 TITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .08; .06; .0294 mg/g; mg/g; mg/g N 20181231 43419-865_2a43db72-7e0f-4bf2-b9e4-81ef73a2f989 43419-865 HUMAN OTC DRUG LANEIGE SATIN FINISH TWIN PACT NO. 23 TITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .08; .06; .0294 mg/g; mg/g; mg/g N 20181231 43419-866_2a43db72-7e0f-4bf2-b9e4-81ef73a2f989 43419-866 HUMAN OTC DRUG LANEIGE SATIN FINISH TWIN PACT NO. 25 TITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .08; .06; .0294 mg/g; mg/g; mg/g N 20181231 43419-867_2a43db72-7e0f-4bf2-b9e4-81ef73a2f989 43419-867 HUMAN OTC DRUG LANEIGE SATIN FINISH TWIN PACT NO. 31 TITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 AMOREPACIFIC TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .08; .06; .0294 mg/g; mg/g; mg/g E 20171231 43419-901_bf4c0f3c-2f14-49fb-88a6-5be78b2dea50 43419-901 HUMAN OTC DRUG SONGYUM New Pinesalt SODIUM FLUORIDE PASTE DENTAL 20130305 OTC MONOGRAPH NOT FINAL part355 AMOREPACIFIC SODIUM FLUORIDE .198 g/90g N 20181231 43419-902_313de4c6-5e5d-4376-ba5e-b8f49d2ad619 43419-902 HUMAN OTC DRUG MEDIAN New Marine fluoride SODIUM FLUORIDE PASTE DENTAL 20130305 OTC MONOGRAPH NOT FINAL part355 AMOREPACIFIC SODIUM FLUORIDE .198 g/90g N 20181231 43419-903_ccebb021-c38f-415c-b000-af8083e9802f 43419-903 HUMAN OTC DRUG MEDIAN New Forest SODIUM FLUORIDE PASTE DENTAL 20130305 OTC MONOGRAPH NOT FINAL part355 AMOREPACIFIC SODIUM FLUORIDE .198 g/90g N 20181231 43438-003_afbde6f2-25d3-4898-9435-02cbf8f1aa69 43438-003 HUMAN OTC DRUG Iman Skin Tone Evener BB SPF 15 OXYBENZONE CREAM TOPICAL 20120816 OTC MONOGRAPH NOT FINAL part352 Impala, Inc. OXYBENZONE; OCTINOXATE 3; 7.5 g/100mL; g/100mL N 20181231 43447-2071_85994524-8b8e-489b-94ae-8c4ca6f02a10 43447-2071 HUMAN OTC DRUG SKIN SAKE PETROLATUM OINTMENT TOPICAL 20051201 OTC MONOGRAPH FINAL part346 Skin Sake, LLC PETROLATUM 23 g/71g N 20181231 43447-4410_873bd880-3d3e-4e85-a9d6-9fd0c6a9dcbf 43447-4410 HUMAN OTC DRUG SKIN SAKE Surface Protectant DIMETHICONE OINTMENT TOPICAL 20091001 OTC MONOGRAPH FINAL part347 Skin Sake, LLC DIMETHICONE 2.272 g/113.6g N 20181231 43447-9440_332ac550-5435-45b1-83b3-f8d7c0c43792 43447-9440 HUMAN OTC DRUG Booty Goo ZINC OXIDE OINTMENT TOPICAL 20051201 OTC MONOGRAPH FINAL part346 Skin Sake, LLC ZINC OXIDE 17.75 g/71g N 20181231 43455-0001_c028cd57-f5e6-4dc6-9640-bee5283e1051 43455-0001 HUMAN OTC DRUG LBEL DEFENSE 365 Daily Protective Facial SPF 50 HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura International, LTD HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 5; 7; 5; 4; 6.24; 3.92 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 43455-0002_5fa42a37-7be9-4e1f-a4c2-a33d92e085b2 43455-0002 HUMAN OTC DRUG LBEL HYDRA CALME SPF 15 Intensive Moisturizing Facial OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120325 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 4 mL/100mL; mL/100mL; mL/100mL E 20171231 43455-0003_8dfa0764-2694-4030-9ad5-d5fcbbfecc86 43455-0003 HUMAN OTC DRUG LBEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Normal to Combination Skin OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 4 mL/100mL; mL/100mL; mL/100mL E 20171231 43455-0004_a1740037-6944-4a4e-a6ef-1b9744c62980 43455-0004 HUMAN OTC DRUG LBEL RENOVANCE JOUR Daytime Face SPF 15 All Skin Types OCTINOXATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20120328 OTC MONOGRAPH FINAL part352 VENTURA INTERNATIONAL LTD. OCTINOXATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 3 g/100g; g/100g; g/100g E 20171231 43455-0005_e4fa477d-b315-4e58-a5a9-613f83d0d17a 43455-0005 HUMAN OTC DRUG LBEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face SPF 15 Normal To Dry Skin ENSULIZOLE, HOMOSALATE, OCTINOXATE, OXYBENZONE CREAM TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura International, LTD ENSULIZOLE; HOMOSALATE; OCTINOXATE; OXYBENZONE 2; 2; 7.5; 4 g/100g; g/100g; g/100g; g/100g E 20171231 43455-0006_6e18aae4-b862-4dfb-8f40-a8d42f08384f 43455-0006 HUMAN OTC DRUG LBEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face SPF 15 Normal To Oily Skin ENSULIZOLE, HOMOSALATE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura International, LTD ENSULIZOLE; HOMOSALATE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 1.5; 1; 7.5; 4.5; 1.17 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 43455-0007_a273e9ea-b57b-4711-ab6a-7574362ef54e 43455-0007 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 1 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0008_49be8601-dfc3-4220-b3a0-8431a8d0c49a 43455-0008 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 2 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0009_ed7272a9-0e47-4b10-a877-673ba69769a8 43455-0009 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 3 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0010_4afadbdd-7f78-43f5-a4ce-a5168a55473a 43455-0010 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 4 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0011_fc65c644-236a-4b13-bcce-ef627d970bfb 43455-0011 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 5 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0012_4fa6b1e5-243e-431c-9ac3-f15d0898bc9f 43455-0012 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 6 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0013_7b125d9a-b38f-4551-aaff-fc1b95518472 43455-0013 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 7 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0014_7e04ab31-6ea1-4b98-a02b-00a51a82a2ce 43455-0014 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0015_79720c93-6a6b-4588-99c3-7675e332067f 43455-0015 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 6A OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0016_14eb5f64-af0d-4067-9298-6445bf5a70d5 43455-0016 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 6B OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0017_2a2a128b-b526-418b-9a24-542f51371c98 43455-0017 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8A OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0018_e9ca985e-9902-4c13-bd5c-8057de4b688b 43455-0018 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8B OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0019_020470c6-f822-4885-9a1a-034a22210a84 43455-0019 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8C OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43455-0020_7ac77d74-ac4c-4197-a91b-fd2d4925764b 43455-0020 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 10 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura International, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43459-0152_9b0c0db2-168f-45b3-a2ce-b9204dcccd32 43459-0152 HUMAN OTC DRUG Non-Aspirin Acetaminophen TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part343 Etex Pharm Co., Ltd ACETAMINOPHEN 500 mg/1 E 20171231 43459-0153_9b0c0db2-168f-45b3-a2ce-b9204dcccd32 43459-0153 HUMAN OTC DRUG Non-Aspirin Acetaminophen TABLET ORAL 20100801 OTC MONOGRAPH NOT FINAL part343 Etex Pharm Co., Ltd ACETAMINOPHEN 500 mg/1 E 20171231 43473-308_ed0cf1bd-515d-43ad-b956-114a34cc5fff 43473-308 HUMAN OTC DRUG Health and Beyond Green ALCOHOL LIQUID TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333A Nantong Health & Beyond Hygienic Products Inc ALCOHOL .3 mL/mL N 20181231 43473-801_d89bd7b2-da00-4991-8c17-4274d4b11126 43473-801 HUMAN OTC DRUG Health and Beyond Antiseptic Hand Sanitizer ETHYL ALCOHOL SPRAY TOPICAL 20120520 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 62 mL/100mL N 20181231 43473-802_cb735c02-94db-4a62-b357-3980d4058171 43473-802 HUMAN OTC DRUG Health And Beyond Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 62 mL/100mL N 20181231 43473-803_60641f19-0187-4525-843e-a501a2950e83 43473-803 HUMAN OTC DRUG Health And Beyond Instant Hand Sanitizer Twin Pack Twin Pack ETHYL ALCOHOL KIT TOPICAL 20140627 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. N 20181231 43473-805_201e506e-c0e9-4431-9c52-9a6d67a59a05 43473-805 HUMAN OTC DRUG ALCOHOL ALCOHOL GEL TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 65 mL/100mL N 20181231 43473-806_94f1019d-e87b-4af1-b2d0-f4b98fe7b849 43473-806 HUMAN OTC DRUG Health And Beyond Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141215 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 62 mL/100mL N 20181231 43473-807_63dc8301-235b-446c-9d29-cfb69716f1b6 43473-807 HUMAN OTC DRUG Health And Beyond Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141215 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 62 mL/100mL N 20181231 43473-810_4538e411-e485-4519-98cb-fcc41744d2f9 43473-810 HUMAN OTC DRUG cotton candy scented anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20171212 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 65 g/100mL N 20181231 43473-812_85edf903-ed5f-4fe8-8c75-29b1be92dad1 43473-812 HUMAN OTC DRUG cotton candy scented anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20171212 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 65 g/100mL N 20181231 43473-814_2ad0c159-26b9-477b-9fad-dfcb3faf12cb 43473-814 HUMAN OTC DRUG lollipop scented anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20171212 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 65 g/100mL N 20181231 43473-818_82e409a2-b41d-4ab7-8241-c5e08e16a47c 43473-818 HUMAN OTC DRUG cupcake scented anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20171212 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 65 g/100mL N 20181231 43473-820_84370230-199e-45fc-b784-dbcb9deb1b38 43473-820 HUMAN OTC DRUG candy apple scented anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20171212 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 65 g/100mL N 20181231 43473-822_27c8d0ad-7d8f-4b0c-bb47-dfb96c76c1d8 43473-822 HUMAN OTC DRUG marshmallow scented anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20171212 OTC MONOGRAPH NOT FINAL part333E Nantong Health & Beyond Hygienic Products Inc. ALCOHOL 65 g/100mL N 20181231 43474-000_98ee4d74-8e11-41e3-ad0c-0a7f089b3725 43474-000 HUMAN OTC DRUG bioCorneum HC Advanced Scar Supervision Anti-Itch HYDROCORTISONE ACETATE GEL TOPICAL 20120510 OTC MONOGRAPH FINAL part348 Enaltus Inc HYDROCORTISONE ACETATE 1 g/100g N 20181231 43474-001_e22951c5-cacf-47cb-9bb3-f722520a33e7 43474-001 HUMAN OTC DRUG bioCorneum plus SPF 30 advanced SCAR SUPERVISION OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE GEL TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Enaltus Inc OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 10; 6 g/100g; g/100g; g/100g; g/100g N 20181231 43478-241_cc9e89fc-2957-4e6d-9330-10c1ec6b0cb5 43478-241 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 20180430 ANDA ANDA075213 Rouses Point Pharm TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 43478-242_cc9e89fc-2957-4e6d-9330-10c1ec6b0cb5 43478-242 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 20180331 ANDA ANDA075265 Rouses Point Pharm TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 43478-243_cc9e89fc-2957-4e6d-9330-10c1ec6b0cb5 43478-243 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 20180331 ANDA ANDA075264 Rouses Point Pharm TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 43478-410_905b7ddc-f00a-4303-9a62-8e4933bffc82 43478-410 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin AEROSOL, METERED SUBLINGUAL 20121016 NDA AUTHORIZED GENERIC NDA021780 Rouses Point Pharm NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 43478-900_54753570-5982-418f-acea-aabf39c8a50b 43478-900 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090225 20190831 NDA AUTHORIZED GENERIC NDA018553 Rouses Point Pharm PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43478-901_54753570-5982-418f-acea-aabf39c8a50b 43478-901 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090225 20190930 NDA AUTHORIZED GENERIC NDA018553 Rouses Point Pharm PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43478-902_54753570-5982-418f-acea-aabf39c8a50b 43478-902 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090225 20190731 NDA AUTHORIZED GENERIC NDA018553 Rouses Point Pharm PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43478-903_54753570-5982-418f-acea-aabf39c8a50b 43478-903 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090225 20190930 NDA AUTHORIZED GENERIC NDA018553 Rouses Point Pharm PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43479-103_a100dade-e063-4099-8c1b-4f9da7341b98 43479-103 HUMAN OTC DRUG EXFOLIKATE ACNE SALICYLIC ACID GEL TOPICAL 20140622 OTC MONOGRAPH FINAL part333D KATE SOMERVILLE SKINCARE, LLC SALICYLIC ACID .5 g/100mL E 20171231 43479-105_9fddca10-e180-41f5-97d6-a104eff97716 43479-105 HUMAN OTC DRUG ANTI BAC ACNE CLEARING BENZOYL PEROXIDE LOTION TOPICAL 20140622 OTC MONOGRAPH FINAL part333D KATE SOMERVILLE SKINCARE, LLC BENZOYL PEROXIDE 5 g/100mL E 20171231 43479-106_fbd213f2-c64f-4c0c-bf40-1ed89cf65ec6 43479-106 HUMAN OTC DRUG EradiKate ACNE TREATMENT SULFUR LIQUID TOPICAL 20140615 OTC MONOGRAPH FINAL part333D Kate Somerville Skincare, LLC SULFUR 10 g/100mL E 20171231 43479-107_318d3729-3106-416d-9075-f7e152747c3f 43479-107 HUMAN OTC DRUG HYDRACLEAR HYDRATING ACNE GEL SALICYLIC ACID GEL TOPICAL 20140622 OTC MONOGRAPH FINAL part333D KATE SOMERVILLE SKINCARE, LLC SALICYLIC ACID .5 g/100mL E 20171231 43479-108_9632f63c-e700-4191-b08e-d39e4d0c0073 43479-108 HUMAN OTC DRUG DERMAL QUENCH CLEAR ANTI-ACNE TREATMENT SALICYLIC ACID GEL TOPICAL 20140622 OTC MONOGRAPH FINAL part333D KATE SOMERVILLE SKINCARE, LLC SALICYLIC ACID .5 g/100mL E 20171231 43479-109_28882755-2df3-42f6-8a6b-db8d20a49233 43479-109 HUMAN OTC DRUG EradiKate Facial Mask SULFUR LOTION TOPICAL 20140615 OTC MONOGRAPH FINAL part333D Kate Somerville Skincare, LLC SULFUR 5 g/100mL E 20171231 43479-201_b11e376b-7b56-4f62-a1e7-0354fdfe4eae 43479-201 HUMAN OTC DRUG Daily Deflector Waterlight SPF 50 TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20140622 OTC MONOGRAPH NOT FINAL part352 KATE SOMERVILLE SKINCARE LLC TITANIUM DIOXIDE; ZINC OXIDE 8.3; 12.6 g/100mL; g/100mL E 20171231 43479-202_c91d8289-0d1a-4b51-b57f-6c097b4b372b 43479-202 HUMAN OTC DRUG DAILY DEFLECTOR MOISTURIZER SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140622 OTC MONOGRAPH FINAL part352 KATE SOMERVILLE SKINCARE, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 43479-203_26e88124-b6be-4b75-b079-2738ec45cab4 43479-203 HUMAN OTC DRUG DAILY DEFLECTOR MOISTURIZER SPF 20 OCTINOXATE, AVOBENZONE, OXYBENZONE LOTION TOPICAL 20140622 OTC MONOGRAPH FINAL part352 KATE SOMERVILLE SKINCARE, LLC OCTINOXATE; AVOBENZONE; OXYBENZONE 7.5; 3; 4 g/100mL; g/100mL; g/100mL E 20171231 43479-204_180cf153-e1dc-4763-a593-2b08f33d9557 43479-204 HUMAN OTC DRUG ILLUMIKATE CC CREAM SPF 50 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20140618 OTC MONOGRAPH FINAL part352 KATE SOMERVILLE SKINCARE, LLC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 3; 6.6 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 43479-205_972eed51-145e-46a4-881d-022c23ca981e 43479-205 HUMAN OTC DRUG BODY GLOW SUNSCREEN SPF 20 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140622 OTC MONOGRAPH FINAL part352 KATE SOMERVILLE SKINCARE, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.5; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 43479-206_8d1155e9-d8b5-4e3c-9339-454d8aa65fed 43479-206 HUMAN OTC DRUG PRIME PROTECTION SPF 15 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE LOTION TOPICAL 20140622 OTC MONOGRAPH FINAL part352 KATE SOMERVILLE SKINCARE, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 10; 7.5; 2.87 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 43479-207_0bc6bb22-cf76-44e0-ba44-565c0ab8d152 43479-207 HUMAN OTC DRUG DAILY DEFLECTOR MOISTURIZER SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20151017 OTC MONOGRAPH FINAL part352 KATE SOMERVILLE SKINCARE, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.79; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 43479-301_10fd8bfc-4c85-4b69-9884-2a7354345c1f 43479-301 HUMAN OTC DRUG ECZEMA THERAPY OATMEAL CREAM TOPICAL 20140618 OTC MONOGRAPH FINAL part347 KATE SOMERVILLE SKINCARE, LLC OATMEAL 1 g/100mL E 20171231 43479-501_3b202664-379c-4b6d-805b-ecbcab901c3c 43479-501 HUMAN OTC DRUG 24 HOUR PIMPLE PUNISHER SALICYLIC ACID KIT 20140622 OTC MONOGRAPH FINAL part333D KATE SOMERVILLE SKINCARE, LLC E 20171231 43482-1728_8d5419c0-996b-4d0e-af63-fbc6b84f7581 43482-1728 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20080603 UNAPPROVED MEDICAL GAS Reliable Medical Inc. OXYGEN 99 L/100L E 20171231 43485-101_cdc90b78-589c-49b1-81ce-bd23f68bfe7d 43485-101 HUMAN PRESCRIPTION DRUG Spritam levetiracetam TABLET, FOR SUSPENSION ORAL 20160205 NDA NDA207958 Aprecia Pharmaceuticals, LLC LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43485-102_cdc90b78-589c-49b1-81ce-bd23f68bfe7d 43485-102 HUMAN PRESCRIPTION DRUG Spritam levetiracetam TABLET, FOR SUSPENSION ORAL 20160205 NDA NDA207958 Aprecia Pharmaceuticals, LLC LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43485-103_cdc90b78-589c-49b1-81ce-bd23f68bfe7d 43485-103 HUMAN PRESCRIPTION DRUG Spritam levetiracetam TABLET, FOR SUSPENSION ORAL 20160205 NDA NDA207958 Aprecia Pharmaceuticals, LLC LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43485-104_cdc90b78-589c-49b1-81ce-bd23f68bfe7d 43485-104 HUMAN PRESCRIPTION DRUG Spritam levetiracetam TABLET, FOR SUSPENSION ORAL 20160205 NDA NDA207958 Aprecia Pharmaceuticals, LLC LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43489-100_616275c0-1bee-5bf8-e053-2991aa0a234b 43489-100 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110415 ANDA ANDA090752 Secan Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43489-101_616275c0-1bee-5bf8-e053-2991aa0a234b 43489-101 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160516 ANDA ANDA090752 Secan Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43489-102_616275c0-1bee-5bf8-e053-2991aa0a234b 43489-102 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110415 ANDA ANDA090752 Secan Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 43489-122_60577052-36f9-61b5-e053-2a91aa0a6834 43489-122 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20160815 ANDA ANDA205102 Secan Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43489-124_60577052-36f9-61b5-e053-2a91aa0a6834 43489-124 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20151218 ANDA ANDA205102 Secan Pharmaceuticals, Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43492-0001_92851e70-4330-4122-84e0-b96c6f77f666 43492-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20080720 UNAPPROVED MEDICAL GAS Scheffe RX Inc OXYGEN 99 L/100L E 20171231 43493-0001_5e077cb6-5443-00fd-e053-2a91aa0a1e69 43493-0001 HUMAN OTC DRUG Pain Relief Rub Iampur Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20171030 OTC MONOGRAPH NOT FINAL part348 Avaria Health & Beauty Corp MENTHOL; CAMPHOR (NATURAL); METHYL SALICYLATE 4; 4; 11 g/100g; g/100g; g/100g N 20181231 43493-0002_26361049-6743-491c-b895-3f931e5b0f10 43493-0002 HUMAN OTC DRUG Pain Relieving Iampur Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part348 Avaria Health & Beauty Corp MENTHOL; CAMPHOR (NATURAL); METHYL SALICYLATE 4; 4; 11 g/g; g/g; g/g N 20181231 43493-0003_60198d2e-4de4-3fa0-e053-2a91aa0afaf7 43493-0003 HUMAN OTC DRUG Kalaya Pain Relief 6X with Arnica Pain Relief Cream CREAM TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part348 Avaria Health & Beauty Corp METHYL SALICYLATE; MENTHOL; CAMPHOR (NATURAL); EUCALYPTUS OIL 11; 4; 4; .5 g/100g; g/100g; g/100g; g/100g N 20191231 43498-100_e45ae9ca-bf6c-4920-9c79-b31451044f5c 43498-100 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 43498-101_39241eb8-e85d-4cc1-aabe-9b8df3559c44 43498-101 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 43498-102_8dd044d2-8672-4d93-a9d1-5b6cf6c6f226 43498-102 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 43498-103_7a5b826d-142a-4535-bb81-55c2670adff0 43498-103 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 43498-104_83500014-6074-4129-a785-7589ef73ad33 43498-104 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 43498-105_e867523e-6d50-4d6e-8c30-65dc4bfc0efa 43498-105 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 43498-106_184617a8-fce6-4d9c-ad1c-9bf0915c810a 43498-106 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 43498-107_711b28eb-3349-4d68-8d4a-742b363b22e3 43498-107 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 43498-108_6eec8336-d2a4-4598-ae71-95d77fb1e84f 43498-108 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 43498-109_8c16b594-2234-492d-9581-65aa0f79895c 43498-109 HUMAN PRESCRIPTION DRUG Burkhart Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 43498-150_5530f877-9c8d-4182-9f5c-20fbeb56f118 43498-150 HUMAN PRESCRIPTION DRUG Burkhart Neutral pH Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 4.086 g/454g N 20181231 43498-151_c35dc54c-3ce4-4590-9184-9c04dbe1f0c8 43498-151 HUMAN PRESCRIPTION DRUG Burkhart Neutral pH Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE 4.086 g/454g N 20181231 43498-200_26a314c2-c2b9-4c1f-9f82-010aaa98e498 43498-200 HUMAN PRESCRIPTION DRUG Burkhart Stannous Fluoride CONCENTRATE DENTAL 20130201 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc STANNOUS FLUORIDE .3408 g/284g N 20181231 43498-201_d761e494-b6a8-4a3e-8ebe-e0b80b628218 43498-201 HUMAN PRESCRIPTION DRUG Burkhart Stannous Fluoride CONCENTRATE DENTAL 20130201 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc STANNOUS FLUORIDE .3408 g/284g N 20181231 43498-250_8b360da0-0063-454b-9bfb-af43cf2d00ca 43498-250 HUMAN OTC DRUG Burkhart Stannous Fluoride GEL DENTAL 20130105 OTC MONOGRAPH FINAL part355 Burkhart Dental Supply Inc STANNOUS FLUORIDE .116 g/120g N 20181231 43498-251_ba4d7fee-f464-4618-88a1-39001605b7a8 43498-251 HUMAN OTC DRUG Burkhart Stannous Fluoride GEL DENTAL 20130105 OTC MONOGRAPH FINAL part355 Burkhart Dental Supply Inc STANNOUS FLUORIDE .116 g/120g N 20181231 43498-300_485c8709-8293-4d29-8f8c-ae8deb218e5e 43498-300 HUMAN PRESCRIPTION DRUG Burkhart Neutral Sodium Fluoride GEL DENTAL 20130315 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE .597 g/120g E 20171231 43498-301_d6dc0251-95ba-4303-b30b-211a222049de 43498-301 HUMAN PRESCRIPTION DRUG Burkhart Neutral Sodium Fluoride GEL DENTAL 20130315 UNAPPROVED DRUG OTHER Burkhart Dental Supply Inc SODIUM FLUORIDE .597 g/120g E 20171231 43498-310_7033e0e5-d461-4712-aa39-7f12db2fc877 43498-310 HUMAN OTC DRUG Burkhart Topical Anesthetic Benzocaine GEL DENTAL 20151101 OTC MONOGRAPH NOT FINAL part356 Burkhart Dental Supply Inc BENZOCAINE 200 mg/g N 20181231 43498-311_69343b5d-edf1-44e6-931f-f8fa1206dfd8 43498-311 HUMAN OTC DRUG Burkhart Topical Anesthetic Benzocaine GEL DENTAL 20151101 OTC MONOGRAPH NOT FINAL part356 Burkhart Dental Supply Inc BENZOCAINE 200 mg/g N 20181231 43498-312_00ee5b5a-e624-4f52-974b-2e85206f78eb 43498-312 HUMAN OTC DRUG Burkhart Topical Anesthetic Benzocaine GEL DENTAL 20151101 OTC MONOGRAPH NOT FINAL part356 Burkhart Dental Supply Inc BENZOCAINE 200 mg/g N 20181231 43498-313_be8bbe95-31da-4330-9d19-24e5007a79cd 43498-313 HUMAN OTC DRUG Burkhart Topical Anesthetic Benzocaine GEL DENTAL 20151101 OTC MONOGRAPH NOT FINAL part356 Burkhart Dental Supply Inc BENZOCAINE 200 mg/g N 20181231 43498-314_77be1bda-da6a-4628-923a-a430e583349d 43498-314 HUMAN OTC DRUG Burkhart Topical Anesthetic Benzocaine GEL DENTAL 20151101 OTC MONOGRAPH NOT FINAL part356 Burkhart Dental Supply Inc BENZOCAINE 200 mg/g N 20181231 43498-315_43a203c3-8703-479c-9b9f-78c3039e9979 43498-315 HUMAN OTC DRUG Burkhart Topical Anesthetic Benzocaine GEL DENTAL 20151101 OTC MONOGRAPH NOT FINAL part356 Burkhart Dental Supply Inc BENZOCAINE 200 mg/g N 20181231 43498-316_04c8338e-ed8c-43b9-bf08-c444207418d5 43498-316 HUMAN OTC DRUG Burkhart Topical Anesthetic Benzocaine GEL DENTAL 20151101 OTC MONOGRAPH NOT FINAL part356 Burkhart Dental Supply Inc BENZOCAINE 200 mg/g N 20181231 43498-317_b4c9f4fc-ceff-484c-a848-d8adcc6c66c0 43498-317 HUMAN OTC DRUG Burkhart Topical Anesthetic Benzocaine GEL DENTAL 20151101 OTC MONOGRAPH NOT FINAL part356 Burkhart Dental Supply Inc BENZOCAINE 200 mg/g N 20181231 43498-318_eb42c6f6-658c-4c25-964a-7a6333b0607b 43498-318 HUMAN OTC DRUG Burkhart Topical Anesthetic Benzocaine GEL DENTAL 20151101 OTC MONOGRAPH NOT FINAL part356 Burkhart Dental Supply Inc BENZOCAINE 200 mg/g N 20181231 43498-319_ac063046-d454-4085-94fe-7bc6b3d5b52d 43498-319 HUMAN OTC DRUG Burkhart Topical Anesthetic Benzocaine GEL DENTAL 20151101 OTC MONOGRAPH NOT FINAL part356 Burkhart Dental Supply Inc BENZOCAINE 200 mg/g N 20181231 43526-001_7f72750f-7218-4b98-954f-ae3b2b8d9012 43526-001 HUMAN OTC DRUG IPKN ARTISTS TOUCH BB 01 LIGHT TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.108; .42; .268 mL/14mL; mL/14mL; mL/14mL E 20171231 43526-002_58a190b5-6bda-4bd1-a0a0-a85f2af3a65d 43526-002 HUMAN OTC DRUG IPKN ARTISTS TOUCH BB 02 MEDIUM TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.108; .42; .268 mL/14mL; mL/14mL; mL/14mL E 20171231 43526-003_98f56cb1-4c6c-4bb1-a398-2a180e74ccdd 43526-003 HUMAN OTC DRUG IPKN Moist and Firm BB 01 Light TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.308; 1.2; .768 mL/40mL; mL/40mL; mL/40mL E 20171231 43526-004_a3462cfe-78a2-4de7-a2b1-fd533db76a16 43526-004 HUMAN OTC DRUG IPKN Moist and Firm BB 02 MEDIUM TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.308; 1.2; .768 mL/40mL; mL/40mL; mL/40mL E 20171231 43526-005_e8061fe7-d1a1-4656-809d-d661892093c7 43526-005 HUMAN OTC DRUG IPKN HYDRO AND PORE BB 01 LIGHT itanium dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 4.024; 2.8; 2; 1.392 mL/40mL; mL/40mL; mL/40mL; mL/40mL E 20171231 43526-006_7992879d-4cb5-4675-96f5-ea5193eafe44 43526-006 HUMAN OTC DRUG IPKN HYDRO AND PORE BB 02 MEDIUM itanium dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20120830 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 4.024; 2.8; 2; 1.392 mL/40mL; mL/40mL; mL/40mL; mL/40mL E 20171231 43526-100_be10657e-5388-46a6-83f0-55fd5527c8d3 43526-100 HUMAN OTC DRUG IPKN ARTISTS TOUCH BB 01 LIGHT TITANIUM DIOXIDE CREAM TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.1088; .42; .2688 mL/14mL; mL/14mL; mL/14mL E 20171231 43526-101_4f715d08-4cdd-4210-a2c4-3be4bf2991b0 43526-101 HUMAN OTC DRUG IPKN ARTISTS TOUCH BB 02 Medium TITANIUM DIOXIDE CREAM TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.1088; .42; .2688 mL/14mL; mL/14mL; mL/14mL E 20171231 43526-102_814ff1cd-5997-4173-acef-cd09db548790 43526-102 HUMAN OTC DRUG IPKN Moist and Firm BB 01 Light TITANIUM DIOXIDE CREAM TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.308; 1.2; .768 mL/40mL; mL/40mL; mL/40mL E 20171231 43526-103_79203944-463e-4054-a6b1-dd29919724fa 43526-103 HUMAN OTC DRUG IPKN Moist and Firm BB 02 Medium TITANIUM DIOXIDE CREAM TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.308; 1.2; .768 mL/40mL; mL/40mL; mL/40mL E 20171231 43526-104_9720953e-1878-4413-9903-f191ff19ec74 43526-104 HUMAN OTC DRUG IPKN HYDRO AND PORE BB 01 LIGHT Titanium dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 4.0248; 2.8; 2; 1.392 mL/40mL; mL/40mL; mL/40mL; mL/40mL E 20171231 43526-105_4e65280b-dd17-49c2-b84e-69ab72015b3c 43526-105 HUMAN OTC DRUG IPKN HYDRO AND PORE BB 02 MEDIUM Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 4.0248; 2.8; 2; 1.392 mL/40mL; mL/40mL; mL/40mL; mL/40mL E 20171231 43526-108_a7f5276e-cd9d-47b2-93fc-f8d3cd69e55b 43526-108 HUMAN OTC DRUG IPKN Moist and Firm BB 03 Light Medium Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20180130 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 4.02; 2.8; 1.88; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL N 20191231 43526-109_808ec001-4468-4284-b7a3-a64428de3dcc 43526-109 HUMAN OTC DRUG IPKN Moist and Firm BB 04 Medium Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20180130 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 4.02; 2.8; 1.88; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL N 20191231 43526-111_e08e006c-c4b6-4a13-9a8e-76fa1bff2d56 43526-111 HUMAN OTC DRUG IPKN MOIST AND FIRM BB 01 FAIR Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20180130 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 4.02; 2.8; 1.88; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL N 20191231 43526-112_fb47fa19-83da-431a-b6c6-bc26f1586fcf 43526-112 HUMAN OTC DRUG IPKN MOIST AND FIRM BB 02 Light Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20180130 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 4.02; 2.8; 1.88; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL N 20191231 43526-113_b14dd997-cec2-43d8-95d2-6aef3d488c0d 43526-113 HUMAN OTC DRUG Magis Lene Collagen Choc Extra Gold BB Cream Ethylhexyl Methoxycinnamate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20180130 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 4.305; .96 g/50g; g/50g; g/50g N 20191231 43526-114_b80100b2-ba67-443e-b44e-c69659d94aa5 43526-114 HUMAN OTC DRUG Magis Lene Brilliant Gold CC Cream XQ Ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide CREAM TOPICAL 20180130 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.75; 3.025; 2.695 g/55g; g/55g; g/55g N 20191231 43526-119_ec11c679-83a6-4482-baef-db9a5de34c7a 43526-119 HUMAN OTC DRUG Flash Radiant Primer Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate CREAM TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.136; 2; 1.2 mg/40mL; mg/40mL; mg/40mL N 20191231 43526-120_1825b9e0-98ff-4f64-90e2-b8bc58848994 43526-120 HUMAN OTC DRUG IPKN Pore Apple Sun Block OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE 2.72; 1.92; 1.8; .996 mg/40mL; mg/40mL; mg/40mL; mg/40mL N 20191231 43526-121_4f87e7fa-72e9-4a1a-8352-6d52b71d698a 43526-121 HUMAN OTC DRUG IPKN MOIST AND FIRM BB 05 MEDIUM TAN TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 4.2; 2.8; 1.88; 1.52 mg/40mL; mg/40mL; mg/40mL; mg/40mL N 20191231 43526-122_959a45a7-8999-4174-952e-74f64628b9a5 43526-122 HUMAN OTC DRUG COLOR CORRECTING PRIMER GREEN OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 2; 1.96; 1.7 mg/40mL; mg/40mL; mg/40mL N 20191231 43526-123_022617ce-8613-421f-98b1-a0160bb38288 43526-123 HUMAN OTC DRUG COLOR CORRECTING PRIMER PURPLE OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 2; 1.96; 1.66 mg/40mL; mg/40mL; mg/40mL N 20191231 43526-125_0988f24d-da94-4388-8c86-331fdfb90424 43526-125 HUMAN OTC DRUG IPKN Twinkle Velvet Founcushion 21 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.58; .8; .48 g/12g; g/12g; g/12g N 20191231 43526-126_0e3262b6-e687-4b03-b694-2e586cae5ee4 43526-126 HUMAN OTC DRUG IPKN Twinkle Velvet Founcushion 23 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.58; .8; .48 g/12g; g/12g; g/12g N 20191231 43526-127_b99f5eca-a758-444e-80fe-4b5fef497991 43526-127 HUMAN OTC DRUG IPKN CITY PROOF SUN MIST Homosalate, Octocrylene, Octisalate, Avobenzone CREAM TOPICAL 20170502 OTC MONOGRAPH NOT FINAL part352 Inel Cosmetics Co., Ltd. HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 6.175; 3.25; 2.925; 1.95 mg/65mL; mg/65mL; mg/65mL; mg/65mL N 20181231 43528-002_0736ed59-7d96-4803-9426-88f97cd21fcb 43528-002 VACCINE HEPLISAV-B Hepatitis B Vaccine (Recombinant) Adjuvanted INJECTION, SOLUTION INTRAMUSCULAR 20180101 BLA BLA125428 Dynavax Technologies Corporation HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 20 ug/.5mL Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 43538-100_8503d2d6-aae0-43e0-b2b1-e732d5681b1a 43538-100 HUMAN PRESCRIPTION DRUG Sumaxin Cleansing Pads sulfacetamide sodium and Sulfur CLOTH TOPICAL 20090101 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 40 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 43538-101_8503d2d6-aae0-43e0-b2b1-e732d5681b1a 43538-101 HUMAN PRESCRIPTION DRUG Sumaxin CP sulfacetamide sodium and sulfur KIT 20110801 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals, Inc. N 20181231 43538-130_22cd5b57-d1a0-450e-91a2-c8deb9e7742a 43538-130 HUMAN PRESCRIPTION DRUG Sumaxin Wash sodium sulfacetamide 9%-sulfur 4% SOLUTION TOPICAL 20091030 UNAPPROVED OTHER Medimetriks Pharmaceutical inc SULFACETAMIDE SODIUM; SULFUR 90; 40 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 43538-170_bb79bcf9-ea7f-4537-92b7-349f6f6eebed 43538-170 HUMAN PRESCRIPTION DRUG Clindacin P clindamycin phosphate SWAB TOPICAL 20110220 ANDA ANDA065049 Medimetriks Pharmaceuticals, Inc. CLINDAMYCIN PHOSPHATE 10 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 43538-171_bb79bcf9-ea7f-4537-92b7-349f6f6eebed 43538-171 HUMAN PRESCRIPTION DRUG Clindacin PAC clindamycin phosphate SWAB TOPICAL 20110220 ANDA ANDA065049 Medimetriks Pharmaceuticals, Inc. CLINDAMYCIN PHOSPHATE 10 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 43538-172_d93f2c92-4715-460e-be6a-491106735140 43538-172 HUMAN PRESCRIPTION DRUG Clindacin ETZ clindamycin phosphate SWAB TOPICAL 20130615 ANDA ANDA065049 Medimetriks Pharmaceuticals, Inc. CLINDAMYCIN PHOSPHATE 10 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 43538-173_d93f2c92-4715-460e-be6a-491106735140 43538-173 HUMAN PRESCRIPTION DRUG Clindacin ETZ clindamycin phosphate KIT 20130615 ANDA ANDA065049 Medimetriks Pharmaceuticals, Inc. N 20181231 43538-176_e6fed013-82dd-46a1-ba90-2bbe5ec18801 43538-176 HUMAN PRESCRIPTION DRUG Neuac clindamycin phosphate and benzoyl peroxide GEL TOPICAL 20140615 ANDA ANDA090979 Medimetriks Pharmaceuticals CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE 10; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 43538-177_62a72d94-5131-426a-9223-b944efe4628e 43538-177 HUMAN PRESCRIPTION DRUG Neuac Kit clindamycin phosphate and benzoyl peroxide KIT TOPICAL 20140615 ANDA ANDA090979 Medimetriks Pharmaceuticals N 20181231 43538-180_89a3ae32-b989-4011-af8e-8e021fbcecff 43538-180 HUMAN PRESCRIPTION DRUG Rosadan metronidazole CREAM TOPICAL 20110830 ANDA ANDA077549 Medimetriks Pharmaceuticals, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 43538-181_89a3ae32-b989-4011-af8e-8e021fbcecff 43538-181 HUMAN PRESCRIPTION DRUG Rosadan metronidazole CREAM TOPICAL 20110830 ANDA ANDA077549 Medimetriks Pharmaceuticals, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 43538-182_3b46f039-e92b-42dc-8e50-eb6ddc5700c0 43538-182 HUMAN PRESCRIPTION DRUG Rosadan metronidazole GEL TOPICAL 20120415 ANDA ANDA078178 Medimetriks Pharmaceuticals, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 43538-183_3b46f039-e92b-42dc-8e50-eb6ddc5700c0 43538-183 HUMAN PRESCRIPTION DRUG Rosadan metronidazole KIT 20110801 ANDA ANDA078178 Medimetriks Pharmaceuticals, Inc. N 20181231 43538-190_9660775d-0c21-4225-a11f-f52805af03c8 43538-190 HUMAN PRESCRIPTION DRUG Sumadan Wash sulfacetamide sodium and sulfur CREAM TOPICAL 20110710 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals Inc. SULFACETAMIDE SODIUM; SULFUR 90; 45 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 43538-191_9660775d-0c21-4225-a11f-f52805af03c8 43538-191 HUMAN PRESCRIPTION DRUG Sumadan sulfacetamide sodium and sulfur KIT 20110801 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals Inc. E 20171231 43538-192_fcb32e4a-1128-4e6d-b1b7-8e43f60713d1 43538-192 HUMAN PRESCRIPTION DRUG SUMADAN XLT sulfacetamide sodium, sulfur, avobenzone, octinoxate, and octisalate KIT 20131201 UNAPPROVED DRUG OTHER Medimetriks Pharmaceuticals Inc. E 20171231 43538-290_c31434b6-b573-49a8-85bd-9f378436432b 43538-290 HUMAN OTC DRUG Niseko Sunscreen SPF 25 Avobenzone, Octinoxate, and Octisalate CREAM TOPICAL 20131115 OTC MONOGRAPH FINAL part352 Medimetriks Pharmaceuticals, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/g; mg/g; mg/g N 20181231 43538-300_127980e2-98fd-4dfb-87a6-e8ed31f577e8 43538-300 HUMAN PRESCRIPTION DRUG CENTANY mupirocin OINTMENT TOPICAL 20090226 NDA NDA050788 Medimetriks Pharmaceuticals Inc MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 43538-310_4a890c5e-24ad-425e-ab31-bf7f32e3f54f 43538-310 HUMAN PRESCRIPTION DRUG Centany AT Mupirocin OINTMENT TOPICAL 20101115 NDA NDA050788 Medimetriks Pharmaceuticals, Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 43538-320_e3c0618a-262f-43aa-aa9c-e2db1a627940 43538-320 HUMAN PRESCRIPTION DRUG Xepi ozenoxacin CREAM TOPICAL 20171215 NDA NDA208945 Medimetriks Pharmaceuticals, Inc. OZENOXACIN 10 mg/g Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 43538-500_41403ecf-d764-4109-9e3a-e7cf3495ef88 43538-500 HUMAN PRESCRIPTION DRUG Ciclodan ciclopirox SOLUTION TOPICAL 20110410 ANDA ANDA078233 Medimetriks Pharmaceuticals, Inc. CICLOPIROX 2.28 g/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 43538-501_41403ecf-d764-4109-9e3a-e7cf3495ef88 43538-501 HUMAN PRESCRIPTION DRUG Ciclodan ciclopirox SOLUTION TOPICAL 20110410 ANDA ANDA078233 Medimetriks Pharmaceuticals, Inc. CICLOPIROX 2.28 g/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 43538-540_56413dd5-93d2-4953-919a-cabefce1b6ea 43538-540 HUMAN PRESCRIPTION DRUG Loprox ciclopirox olamine CREAM TOPICAL 20160114 NDA NDA018748 Medimetriks Pharmaceuticals, Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 43538-541_56413dd5-93d2-4953-919a-cabefce1b6ea 43538-541 HUMAN PRESCRIPTION DRUG Loprox Ciclopirox Olamine KIT 20160613 NDA NDA018748 Medimetriks Pharmaceuticals, Inc. N 20181231 43538-550_710515f6-ea6b-4b28-9ca6-a74619e157ec 43538-550 HUMAN PRESCRIPTION DRUG Loprox ciclopirox olamine SUSPENSION TOPICAL 20161014 NDA NDA019824 Medimetriks Pharmaceuticals, Inc. CICLOPIROX OLAMINE 7.7 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 43538-551_710515f6-ea6b-4b28-9ca6-a74619e157ec 43538-551 HUMAN PRESCRIPTION DRUG Loprox Ciclopirox Olamine KIT 20161014 NDA NDA019824 Medimetriks Pharmaceuticals, Inc. N 20181231 43538-600_61c1af25-8a4b-44e2-aa16-93d741200787 43538-600 HUMAN PRESCRIPTION DRUG Morgidox doxycycline hyclate CAPSULE ORAL 20110315 ANDA ANDA062396 Medimetriks Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20191231 43538-601_61c1af25-8a4b-44e2-aa16-93d741200787 43538-601 HUMAN PRESCRIPTION DRUG Morgidox doxycycline hyclate CAPSULE ORAL 20110315 ANDA ANDA062396 Medimetriks Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20191231 43538-610_61c1af25-8a4b-44e2-aa16-93d741200787 43538-610 HUMAN PRESCRIPTION DRUG Morgidox doxycycline hyclate CAPSULE ORAL 20110315 ANDA ANDA062396 Medimetriks Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20191231 43538-611_61c1af25-8a4b-44e2-aa16-93d741200787 43538-611 HUMAN PRESCRIPTION DRUG Morgidox doxycycline hyclate CAPSULE ORAL 20110315 ANDA ANDA062396 Medimetriks Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20191231 43538-620_ab75ede2-61a6-420a-a82b-6ab025888c65 43538-620 HUMAN PRESCRIPTION DRUG Morgidox doxycycline hyclate CAPSULE ORAL 19841107 ANDA ANDA062396 Medimetriks Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 43538-621_ab75ede2-61a6-420a-a82b-6ab025888c65 43538-621 HUMAN PRESCRIPTION DRUG Morgidox doxycycline hyclate KIT 19841107 ANDA ANDA062396 Medimetriks Pharmaceuticals, Inc. N 20181231 43538-900_8cd68981-1b12-44b9-9e6b-d2e5a1f29cb6 43538-900 HUMAN PRESCRIPTION DRUG Synalar fluocinolone acetonide CREAM TOPICAL 20120927 NDA NDA012787 Medimetriks Pharmaceuticals, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43538-901_8cd68981-1b12-44b9-9e6b-d2e5a1f29cb6 43538-901 HUMAN PRESCRIPTION DRUG Synalar Fluocinolone acetonide KIT TOPICAL 20121215 NDA NDA012787 Medimetriks Pharmaceuticals, Inc. N 20181231 43538-910_e734306c-4ca3-4978-9a21-7f5ee4823f13 43538-910 HUMAN PRESCRIPTION DRUG Synalar fluocinolone acetonide OINTMENT TOPICAL 20120927 NDA NDA013960 Medimetriks Pharmaceuticals, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43538-911_e734306c-4ca3-4978-9a21-7f5ee4823f13 43538-911 HUMAN PRESCRIPTION DRUG Synalar Fluocinolone acetonide KIT TOPICAL 20121215 NDA NDA013960 Medimetriks Pharmaceuticals, Inc. N 20181231 43538-920_b461b647-e046-47ca-b022-e4bb4d4b1ded 43538-920 HUMAN PRESCRIPTION DRUG Synalar fluocinolone acetonide SOLUTION TOPICAL 20120531 NDA NDA015296 Medimetriks Pharmaceuticals, Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43538-920_eefa254b-8600-437d-aafa-596eec0a28da 43538-920 HUMAN PRESCRIPTION DRUG Synalar fluocinolone acetonide SOLUTION TOPICAL 20120815 NDA NDA015296 Medimetriks Pharmaceuticals, Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43538-921_b461b647-e046-47ca-b022-e4bb4d4b1ded 43538-921 HUMAN PRESCRIPTION DRUG Synalar TS fluocinolone acetonide KIT 20120815 NDA NDA015296 Medimetriks Pharmaceuticals, Inc. N 20181231 43538-921_eefa254b-8600-437d-aafa-596eec0a28da 43538-921 HUMAN PRESCRIPTION DRUG Synalar TS fluocinolone acetonide KIT 20120815 NDA NDA015296 Medimetriks Pharmaceuticals, Inc. N 20181231 43538-940_0a6f9938-b6e6-4d4e-a461-f692a78daabe 43538-940 HUMAN PRESCRIPTION DRUG Neo-Synalar neomycin sulfate and fluocinolone acetonide CREAM TOPICAL 19630611 ANDA ANDA060700 Medimetriks Pharmaceuticals NEOMYCIN SULFATE; FLUOCINOLONE ACETONIDE 3.5; .25 mg/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43538-941_605d28cc-d655-4ef4-be4f-68b7e1b12aa9 43538-941 HUMAN PRESCRIPTION DRUG Neo-Synalar neomycin sulfate and fluocinolone acetonide KIT 20140715 ANDA ANDA060700 Medimetriks Pharmaceuticals N 20181231 43538-950_a3bb72c8-50a8-4794-a2c6-08b1ba31ce31 43538-950 HUMAN PRESCRIPTION DRUG Clodan clobetasol propionate SHAMPOO TOPICAL 20140622 ANDA ANDA090974 Medimetriks Pharmaceuticals CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 43538-951_1b3f369f-9964-41ae-9a69-f4238e0b33fb 43538-951 HUMAN PRESCRIPTION DRUG Clodan Kit clobetasol propionate KIT 20140615 ANDA ANDA090974 Medimetriks Pharmaceuticals N 20191231 43547-221_7b4970d4-813d-44e2-bd03-eb6de35712b3 43547-221 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 Solco Healthcare US, LLC LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-222_7b4970d4-813d-44e2-bd03-eb6de35712b3 43547-222 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 Solco Healthcare US, LLC LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-223_7b4970d4-813d-44e2-bd03-eb6de35712b3 43547-223 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 Solco Healthcare US, LLC LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-224_7b4970d4-813d-44e2-bd03-eb6de35712b3 43547-224 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 Solco Healthcare US, LLC LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-226_5ec90194-4b1c-406f-b1eb-ce631fa7b7fe 43547-226 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130115 ANDA ANDA086988 Solco Healthcare LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43547-248_d1b2cf70-0b4c-4ed2-9064-5687c88d146f 43547-248 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43547-249_d1b2cf70-0b4c-4ed2-9064-5687c88d146f 43547-249 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43547-250_d1b2cf70-0b4c-4ed2-9064-5687c88d146f 43547-250 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43547-251_4146b956-96be-4115-b511-3d4cbc484ad5 43547-251 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20100515 ANDA ANDA085461 Solco Healthcare US LLC CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43547-252_4146b956-96be-4115-b511-3d4cbc484ad5 43547-252 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20100515 ANDA ANDA085472 Solco Healthcare US LLC CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43547-253_4146b956-96be-4115-b511-3d4cbc484ad5 43547-253 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20100515 ANDA ANDA085475 Solco Healthcare US LLC CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 43547-254_0f94a205-76ec-4fb5-957a-9a466b996c5a 43547-254 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Solco Healthcare US LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 43547-255_0f94a205-76ec-4fb5-957a-9a466b996c5a 43547-255 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Solco Healthcare US LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 43547-256_0f94a205-76ec-4fb5-957a-9a466b996c5a 43547-256 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Solco Healthcare US LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 43547-257_0f94a205-76ec-4fb5-957a-9a466b996c5a 43547-257 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Solco Healthcare US LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 43547-258_f11232f0-6ba0-4719-94cd-6f04562f2542 43547-258 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil SOLUTION TOPICAL 20100601 NDA NDA016831 Solco Healthcare US LLC FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 43547-259_f11232f0-6ba0-4719-94cd-6f04562f2542 43547-259 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil SOLUTION TOPICAL 20100601 NDA NDA016831 Solco Healthcare US LLC FLUOROURACIL 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 43547-263_48be1cda-69dc-46d9-a2c4-55d4a5ef04fa 43547-263 HUMAN PRESCRIPTION DRUG benzphetamine hydrochloride benzphetamine hydrochloride TABLET ORAL 20110801 ANDA ANDA090473 Solco Healthcare US LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII E 20171231 43547-264_7fbc0874-0178-46d6-a880-cdb3854c4a93 43547-264 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20110801 ANDA ANDA089452 Solco Healthcare US LLC PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII E 20171231 43547-265_52afc5ea-5e71-49c0-9f49-3e12ade2975f 43547-265 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20121015 ANDA ANDA090007 Solco Healthcare U.S., LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-266_52afc5ea-5e71-49c0-9f49-3e12ade2975f 43547-266 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20121015 ANDA ANDA090007 Solco Healthcare U.S., LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-267_52afc5ea-5e71-49c0-9f49-3e12ade2975f 43547-267 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20121015 ANDA ANDA090007 Solco Healthcare U.S., LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-268_fbd8dddf-d31c-4fec-b423-79b024ad05ea 43547-268 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43547-269_fbd8dddf-d31c-4fec-b423-79b024ad05ea 43547-269 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43547-270_fbd8dddf-d31c-4fec-b423-79b024ad05ea 43547-270 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43547-271_fbd8dddf-d31c-4fec-b423-79b024ad05ea 43547-271 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43547-272_fbd8dddf-d31c-4fec-b423-79b024ad05ea 43547-272 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43547-273_fbd8dddf-d31c-4fec-b423-79b024ad05ea 43547-273 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43547-274_fbd8dddf-d31c-4fec-b423-79b024ad05ea 43547-274 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Solco healthcare U.S., LLC ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 43547-275_1d634804-3334-4cef-b67f-89866ade345b 43547-275 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20111101 ANDA ANDA200292 Solco Healthcare US, LLC DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 43547-276_1d634804-3334-4cef-b67f-89866ade345b 43547-276 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20111101 ANDA ANDA200292 Solco Healthcare US, LLC DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 43547-277_eff37327-ff5c-4b80-9ffe-3ab00635bd3f 43547-277 HUMAN PRESCRIPTION DRUG Irbesartan IRBESARTAN TABLET ORAL 20120927 ANDA ANDA203071 Solco healthcare U.S., LLC IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-278_eff37327-ff5c-4b80-9ffe-3ab00635bd3f 43547-278 HUMAN PRESCRIPTION DRUG Irbesartan IRBESARTAN TABLET ORAL 20120927 ANDA ANDA203071 Solco healthcare U.S., LLC IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-279_eff37327-ff5c-4b80-9ffe-3ab00635bd3f 43547-279 HUMAN PRESCRIPTION DRUG Irbesartan IRBESARTAN TABLET ORAL 20120927 ANDA ANDA203071 Solco healthcare U.S., LLC IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-280_d1cb0c2a-fb8c-4733-8ab0-6b934224f676 43547-280 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120315 ANDA ANDA078032 SOLCO HEALTHCARE US, LLC ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43547-281_d1cb0c2a-fb8c-4733-8ab0-6b934224f676 43547-281 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120315 ANDA ANDA078032 SOLCO HEALTHCARE US, LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43547-282_d1cb0c2a-fb8c-4733-8ab0-6b934224f676 43547-282 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120315 ANDA ANDA078032 SOLCO HEALTHCARE US, LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 43547-283_7804e132-fde4-4582-bb45-0a06eb13d1c2 43547-283 HUMAN PRESCRIPTION DRUG TELMISARTAN TELMISARTAN TABLET ORAL 20170820 ANDA ANDA207882 Solco Healthcare US, LLC TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-284_7804e132-fde4-4582-bb45-0a06eb13d1c2 43547-284 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20170820 ANDA ANDA207882 Solco Healthcare US, LLC TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-285_7804e132-fde4-4582-bb45-0a06eb13d1c2 43547-285 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20170820 ANDA ANDA207882 Solco Healthcare US, LLC TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-288_279af5be-d25c-41f1-a6b5-676e07a2618b 43547-288 HUMAN PRESCRIPTION DRUG bupropion Bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA202304 Solco Healthcare US LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43547-289_279af5be-d25c-41f1-a6b5-676e07a2618b 43547-289 HUMAN PRESCRIPTION DRUG bupropion bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA202304 Solco Healthcare US LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43547-290_279af5be-d25c-41f1-a6b5-676e07a2618b 43547-290 HUMAN PRESCRIPTION DRUG bupropion bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA202304 Solco Healthcare US LLC BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43547-302_1a1ae3f9-f3ef-4cea-b3ba-527f085fd87c 43547-302 HUMAN PRESCRIPTION DRUG ARIPIPRAZOLE aripiprazole TABLET ORAL 20171204 ANDA ANDA205363 Solco Healthcare U.S., LLC ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 43547-303_1a1ae3f9-f3ef-4cea-b3ba-527f085fd87c 43547-303 HUMAN PRESCRIPTION DRUG ARIPIPRAZOLE aripiprazole TABLET ORAL 20171204 ANDA ANDA205363 Solco Healthcare U.S., LLC ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 43547-304_1a1ae3f9-f3ef-4cea-b3ba-527f085fd87c 43547-304 HUMAN PRESCRIPTION DRUG ARIPIPRAZOLE aripiprazole TABLET ORAL 20171204 ANDA ANDA205363 Solco Healthcare U.S., LLC ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 43547-305_1a1ae3f9-f3ef-4cea-b3ba-527f085fd87c 43547-305 HUMAN PRESCRIPTION DRUG ARIPIPRAZOLE aripiprazole TABLET ORAL 20171204 ANDA ANDA205363 Solco Healthcare U.S., LLC ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 43547-306_1a1ae3f9-f3ef-4cea-b3ba-527f085fd87c 43547-306 HUMAN PRESCRIPTION DRUG ARIPIPRAZOLE aripiprazole TABLET ORAL 20171204 ANDA ANDA205363 Solco Healthcare U.S., LLC ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 43547-307_1a1ae3f9-f3ef-4cea-b3ba-527f085fd87c 43547-307 HUMAN PRESCRIPTION DRUG ARIPIPRAZOLE aripiprazole TABLET ORAL 20171204 ANDA ANDA205363 Solco Healthcare U.S., LLC ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 43547-311_efa76dfa-7a2b-4409-ba4e-2ebb33fe37cc 43547-311 HUMAN PRESCRIPTION DRUG VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20151031 ANDA ANDA206083 Solco Healthcare US, LLC VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43547-312_efa76dfa-7a2b-4409-ba4e-2ebb33fe37cc 43547-312 HUMAN PRESCRIPTION DRUG VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20151031 ANDA ANDA206083 Solco Healthcare US, LLC VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43547-313_efa76dfa-7a2b-4409-ba4e-2ebb33fe37cc 43547-313 HUMAN PRESCRIPTION DRUG VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20151031 ANDA ANDA206083 Solco Healthcare US, LLC VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43547-314_efa76dfa-7a2b-4409-ba4e-2ebb33fe37cc 43547-314 HUMAN PRESCRIPTION DRUG VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20151031 ANDA ANDA206083 Solco Healthcare US, LLC VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43547-315_efa76dfa-7a2b-4409-ba4e-2ebb33fe37cc 43547-315 HUMAN PRESCRIPTION DRUG VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20151031 ANDA ANDA206083 Solco Healthcare US, LLC VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43547-320_08297a45-dcc8-469a-9276-4490f078d303 43547-320 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130415 ANDA ANDA090888 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43547-321_08297a45-dcc8-469a-9276-4490f078d303 43547-321 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130415 ANDA ANDA090888 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43547-322_08297a45-dcc8-469a-9276-4490f078d303 43547-322 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20130415 ANDA ANDA090888 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43547-324_87ff00a8-1a84-4e08-92f6-de0460248dce 43547-324 HUMAN PRESCRIPTION DRUG DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE ORAL 20161128 ANDA ANDA207494 Solco Healthcare US LLC DOXYCYCLINE HYCLATE 150 mg/1 N 20181231 43547-325_87ff00a8-1a84-4e08-92f6-de0460248dce 43547-325 HUMAN PRESCRIPTION DRUG DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE ORAL 20161128 ANDA ANDA207494 Solco Healthcare US LLC DOXYCYCLINE HYCLATE 200 mg/1 N 20181231 43547-330_22bf08c2-615b-4b48-af36-1b71a91459dc 43547-330 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20140301 ANDA ANDA203072 Solco Healthcare US, LLC IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43547-331_22bf08c2-615b-4b48-af36-1b71a91459dc 43547-331 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20140301 ANDA ANDA203072 Solco Healthcare US, LLC IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43547-332_b04f3704-552e-497a-aadb-27dde5397510 43547-332 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN TABLET, FILM COATED ORAL 20140111 ANDA ANDA203244 Solco Healthcare U.S., LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-333_b04f3704-552e-497a-aadb-27dde5397510 43547-333 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN TABLET, FILM COATED ORAL 20140111 ANDA ANDA203244 Solco Healthcare U.S., LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-335_32316002-8937-07ed-e054-00144ff88e88 43547-335 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Solco healthcare U.S., LLC BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43547-336_32316002-8937-07ed-e054-00144ff88e88 43547-336 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Solco healthcare U.S., LLC BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43547-337_32316002-8937-07ed-e054-00144ff88e88 43547-337 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Solco healthcare U.S., LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43547-338_32316002-8937-07ed-e054-00144ff88e88 43547-338 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Solco healthcare U.S., LLC BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 43547-339_4cea9aef-8987-486b-83f6-74cd46ddb6c0 43547-339 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20150601 ANDA ANDA077493 Solco Healthcare US, LLC RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 43547-340_4cea9aef-8987-486b-83f6-74cd46ddb6c0 43547-340 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20150601 ANDA ANDA077493 Solco Healthcare US, LLC RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 43547-341_4cea9aef-8987-486b-83f6-74cd46ddb6c0 43547-341 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20150601 ANDA ANDA077493 Solco Healthcare US, LLC RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 43547-342_4cea9aef-8987-486b-83f6-74cd46ddb6c0 43547-342 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20150601 ANDA ANDA077493 Solco Healthcare US, LLC RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 43547-343_4cea9aef-8987-486b-83f6-74cd46ddb6c0 43547-343 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20150601 ANDA ANDA077493 Solco Healthcare US, LLC RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 43547-344_4cea9aef-8987-486b-83f6-74cd46ddb6c0 43547-344 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20150601 ANDA ANDA077493 Solco Healthcare US, LLC RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 43547-345_276c7ef0-fa18-4445-9e43-9d415852f93c 43547-345 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140501 ANDA ANDA203468 Solco Healthcare US, LLC LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-346_276c7ef0-fa18-4445-9e43-9d415852f93c 43547-346 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140501 ANDA ANDA203468 Solco Healthcare US, LLC LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-347_6cfde064-ddcb-49df-a53c-953c40eb1470 43547-347 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 Solco Healthcare US, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43547-348_6cfde064-ddcb-49df-a53c-953c40eb1470 43547-348 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 Solco Healthcare US, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43547-349_6cfde064-ddcb-49df-a53c-953c40eb1470 43547-349 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 Solco Healthcare US, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43547-350_6cfde064-ddcb-49df-a53c-953c40eb1470 43547-350 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 Solco Healthcare US, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43547-351_331dfdb4-f8fe-85db-3a6a-f5acf8d072e6 43547-351 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Solco healthcare U.S., LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-352_331dfdb4-f8fe-85db-3a6a-f5acf8d072e6 43547-352 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Solco healthcare U.S., LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-353_331dfdb4-f8fe-85db-3a6a-f5acf8d072e6 43547-353 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Solco healthcare U.S., LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-354_331dfdb4-f8fe-85db-3a6a-f5acf8d072e6 43547-354 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 Solco healthcare U.S., LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-355_331dfdb4-f8fe-85db-3a6a-f5acf8d072e6 43547-355 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 Solco healthcare U.S., LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-356_331dfdb4-f8fe-85db-3a6a-f5acf8d072e6 43547-356 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 Solco healthcare U.S., LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-357_b741ccd1-dfc1-42ad-9bf8-3f98ffd3055b 43547-357 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20141015 ANDA ANDA203769 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43547-358_b741ccd1-dfc1-42ad-9bf8-3f98ffd3055b 43547-358 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20141015 ANDA ANDA203769 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43547-359_b741ccd1-dfc1-42ad-9bf8-3f98ffd3055b 43547-359 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20141015 ANDA ANDA203769 Solco healthcare U.S., LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 43547-360_3871a816-6ee0-40e5-be02-7709ab6184ec 43547-360 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110601 ANDA ANDA091497 Solco Healthcare US, LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-361_3871a816-6ee0-40e5-be02-7709ab6184ec 43547-361 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 Solco Healthcare US, LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-362_3871a816-6ee0-40e5-be02-7709ab6184ec 43547-362 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 Solco Healthcare US, LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-367_b48f73f1-0367-4787-9562-87891bfd51ea 43547-367 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20150831 ANDA ANDA204821 Solco Healthcare US, LLC VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-368_b48f73f1-0367-4787-9562-87891bfd51ea 43547-368 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20150831 ANDA ANDA204821 Solco Healthcare US, LLC VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-369_b48f73f1-0367-4787-9562-87891bfd51ea 43547-369 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20150831 ANDA ANDA204821 Solco Healthcare US, LLC VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-370_b48f73f1-0367-4787-9562-87891bfd51ea 43547-370 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20150831 ANDA ANDA204821 Solco Healthcare US, LLC VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-373_236e1f8c-1c27-4fcd-bef4-b1b21f8d699c 43547-373 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160125 ANDA ANDA040432 Solco Healthcare US, LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 43547-374_16c7e76f-ff84-4213-86eb-b4e769fcd095 43547-374 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20160613 ANDA ANDA203071 Solco Healthcare U.S., LLC IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-375_16c7e76f-ff84-4213-86eb-b4e769fcd095 43547-375 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20160613 ANDA ANDA203071 Solco Healthcare U.S., LLC IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-376_16c7e76f-ff84-4213-86eb-b4e769fcd095 43547-376 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20160613 ANDA ANDA203071 Solco Healthcare U.S., LLC IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-377_dd1c2744-6a3b-42bd-9e82-b8da1c92dcb8 43547-377 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, COATED ORAL 20161028 ANDA ANDA206654 Solco Healthcare U.S., LLC VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 43547-378_dd1c2744-6a3b-42bd-9e82-b8da1c92dcb8 43547-378 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, COATED ORAL 20161028 ANDA ANDA206654 Solco Healthcare U.S., LLC VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 43547-379_5668f57d-a8a9-4ac4-9e23-64825ecba5f4 43547-379 HUMAN PRESCRIPTION DRUG DULOXETINE Duloxetine CAPSULE, DELAYED RELEASE ORAL 20160120 ANDA ANDA206653 Solco Healthcare US, LLC DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43547-380_5668f57d-a8a9-4ac4-9e23-64825ecba5f4 43547-380 HUMAN PRESCRIPTION DRUG DULOXETINE Duloxetine CAPSULE, DELAYED RELEASE ORAL 20160120 ANDA ANDA206653 Solco Healthcare US, LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43547-381_5668f57d-a8a9-4ac4-9e23-64825ecba5f4 43547-381 HUMAN PRESCRIPTION DRUG DULOXETINE Duloxetine CAPSULE, DELAYED RELEASE ORAL 20160120 ANDA ANDA206653 Solco Healthcare US, LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43547-382_77214500-fdce-4f57-9625-03d861377b31 43547-382 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20161205 ANDA ANDA203713 Solco Healthcare US, LLC DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 43547-383_c0955606-77dc-4022-aed1-4b4270c07c0f 43547-383 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160930 ANDA ANDA204989 Solco Healthcare U.S., LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-384_c0955606-77dc-4022-aed1-4b4270c07c0f 43547-384 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160930 ANDA ANDA204989 Solco Healthcare U.S., LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-385_c0955606-77dc-4022-aed1-4b4270c07c0f 43547-385 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160930 ANDA ANDA204989 Solco Healthcare U.S., LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-386_0a66f606-5e6f-473d-8a1e-9ef316adb2e2 43547-386 HUMAN PRESCRIPTION DRUG Fosinopril sodium fosinopirl sodium TABLET ORAL 20171001 ANDA ANDA205670 Solco Healthcare LLC FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-387_0a66f606-5e6f-473d-8a1e-9ef316adb2e2 43547-387 HUMAN PRESCRIPTION DRUG Fosinopril sodium fosinopril sodium TABLET ORAL 20171001 ANDA ANDA205670 Solco Healthcare LLC FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-388_0a66f606-5e6f-473d-8a1e-9ef316adb2e2 43547-388 HUMAN PRESCRIPTION DRUG Fosinopril sodium fosinopril sodium TABLET ORAL 20171001 ANDA ANDA205670 Solco Healthcare LLC FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-389_c0955606-77dc-4022-aed1-4b4270c07c0f 43547-389 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET ORAL 20161120 ANDA ANDA205101 Solco Healthcare U.S., LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-390_c0955606-77dc-4022-aed1-4b4270c07c0f 43547-390 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET ORAL 20161120 ANDA ANDA205101 Solco Healthcare U.S., LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 43547-391_cd558c7f-abb9-4785-a72b-68ce4a40705d 43547-391 HUMAN PRESCRIPTION DRUG OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide TABLET ORAL 20170424 ANDA ANDA207804 Solco Healthcare US, LLC OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 43547-392_cd558c7f-abb9-4785-a72b-68ce4a40705d 43547-392 HUMAN PRESCRIPTION DRUG OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide TABLET ORAL 20170424 ANDA ANDA207804 Solco Healthcare US, LLC OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43547-393_cd558c7f-abb9-4785-a72b-68ce4a40705d 43547-393 HUMAN PRESCRIPTION DRUG OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide TABLET ORAL 20170424 ANDA ANDA207804 Solco Healthcare US, LLC OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43547-394_9c629ae6-3286-4284-a181-4a0d34bea68a 43547-394 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20170130 ANDA ANDA077370 Solco Healthcare U.S., LLC GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43547-395_9c629ae6-3286-4284-a181-4a0d34bea68a 43547-395 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20170130 ANDA ANDA077370 Solco Healthcare U.S., LLC GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43547-396_9c629ae6-3286-4284-a181-4a0d34bea68a 43547-396 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20170130 ANDA ANDA077370 Solco Healthcare U.S., LLC GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 43547-397_ba6274f4-af1c-42cf-b72f-a4371c225da8 43547-397 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Solco Healthcare U.S., LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43547-398_ba6274f4-af1c-42cf-b72f-a4371c225da8 43547-398 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Solco Healthcare U.S., LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 43547-399_72ab6dba-b643-471b-a34e-4ff3ccef57a9 43547-399 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20170330 ANDA ANDA077797 Solco Healthcare U.S., LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43547-400_72ab6dba-b643-471b-a34e-4ff3ccef57a9 43547-400 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20170330 ANDA ANDA077797 Solco Healthcare U.S., LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43547-401_eea5ef02-73d2-4446-8d5c-7720d847be80 43547-401 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 Solco Healthcare LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43547-402_eea5ef02-73d2-4446-8d5c-7720d847be80 43547-402 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 Solco Healthcare LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43547-403_eea5ef02-73d2-4446-8d5c-7720d847be80 43547-403 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 Solco Healthcare LLC FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 43547-404_a6db5e39-f222-46b4-b3e5-b7c04b2e8900 43547-404 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20020104 ANDA ANDA040377 Solco Healthcare U.S., LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 43547-405_5ec90194-4b1c-406f-b1eb-ce631fa7b7fe 43547-405 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20171215 ANDA ANDA086989 Solco Healthcare LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 43547-409_2c5836c3-2099-452e-b6af-d2d50dc359fd 43547-409 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine CAPSULE ORAL 20170815 ANDA ANDA207188 Solco Healthcare LLC PAROXETINE MESYLATE 7.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 43547-410_882a909b-7c7d-465b-9e7d-063f1ee8acd0 43547-410 HUMAN PRESCRIPTION DRUG QUINAPRIL quinapril TABLET ORAL 20171110 ANDA ANDA205823 Solco Healthcare US, LLC QUINAPRIL HYDROCHLORIDE 5 1/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-411_882a909b-7c7d-465b-9e7d-063f1ee8acd0 43547-411 HUMAN PRESCRIPTION DRUG QUINAPRIL quinapril TABLET ORAL 20171110 ANDA ANDA205823 Solco Healthcare US, LLC QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-412_882a909b-7c7d-465b-9e7d-063f1ee8acd0 43547-412 HUMAN PRESCRIPTION DRUG QUINAPRIL quinapril TABLET ORAL 20171110 ANDA ANDA205823 Solco Healthcare US, LLC QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-413_882a909b-7c7d-465b-9e7d-063f1ee8acd0 43547-413 HUMAN PRESCRIPTION DRUG QUINAPRIL quinapril TABLET ORAL 20160316 ANDA ANDA205823 Solco Healthcare US, LLC QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-414_f9a8920c-0be3-43dd-9cb3-c7d9e448cd80 43547-414 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170830 ANDA ANDA075743 Solco healthcare U.S., LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-415_f9a8920c-0be3-43dd-9cb3-c7d9e448cd80 43547-415 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170830 ANDA ANDA075743 Solco healthcare U.S., LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-416_f9a8920c-0be3-43dd-9cb3-c7d9e448cd80 43547-416 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170830 ANDA ANDA075743 Solco healthcare U.S., LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-417_f9a8920c-0be3-43dd-9cb3-c7d9e448cd80 43547-417 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170830 ANDA ANDA075743 Solco healthcare U.S., LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-418_f9a8920c-0be3-43dd-9cb3-c7d9e448cd80 43547-418 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170830 ANDA ANDA075743 Solco healthcare U.S., LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-419_f9a8920c-0be3-43dd-9cb3-c7d9e448cd80 43547-419 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170830 ANDA ANDA075743 Solco healthcare U.S., LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 43547-441_3a9b6d8a-daa7-49a1-bfc6-a4d988105f18 43547-441 HUMAN PRESCRIPTION DRUG TELMISARTAN AND HYDROCHLOROTHIAZIDE telmisartan and hydrochlorothiazide TABLET ORAL 20180205 ANDA ANDA209028 Solco Healthcare LLC TELMISARTAN; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 43547-442_3a9b6d8a-daa7-49a1-bfc6-a4d988105f18 43547-442 HUMAN PRESCRIPTION DRUG TELMISARTAN AND HYDROCHLOROTHIAZIDE telmisartan and hydrochlorothiazide TABLET ORAL 20180205 ANDA ANDA209028 Solco Healthcare LLC TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 43547-443_3a9b6d8a-daa7-49a1-bfc6-a4d988105f18 43547-443 HUMAN PRESCRIPTION DRUG TELMISARTAN AND HYDROCHLOROTHIAZIDE telmisartan and hydrochlorothiazide TABLET ORAL 20180205 ANDA ANDA209028 Solco Healthcare LLC TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 43553-0000_60dfeda0-e751-1762-e053-2a91aa0a7380 43553-0000 HUMAN OTC DRUG Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules POLOXAMER 188 LIQUID TOPICAL 20171026 OTC MONOGRAPH NOT FINAL part333A ConvaTec Inc POLOXAMER 188 200 mg/mL N 20181231 43553-0001_60dfe363-98ee-da29-e053-2991aa0ae838 43553-0001 HUMAN OTC DRUG ALOE VESTA DAILY MOISTURIZER DIMETHICONE LOTION TOPICAL 20131220 OTC MONOGRAPH FINAL part347 ConvaTec, Inc. DIMETHICONE 30 mg/mL N 20181231 43553-0002_60dff18d-9344-eae0-e053-2991aa0a75e4 43553-0002 HUMAN OTC DRUG SENSI-CARE BODY PETROLATUM, DIMETHICONE CREAM TOPICAL 20131220 OTC MONOGRAPH FINAL part347 ConvaTec Inc. PETROLATUM; DIMETHICONE 30; 1 g/100g; g/100g N 20181231 43553-0003_60dfee48-3569-e544-e053-2991aa0a15c4 43553-0003 HUMAN OTC DRUG Aloe Vesta Clear Antifungal MICONAZOLE NITRATE OINTMENT TOPICAL 20131220 OTC MONOGRAPH FINAL part333C Convatec Inc. MICONAZOLE NITRATE 2 g/100g N 20181231 43553-0004_60dfdbea-a3f6-cee4-e053-2991aa0a5104 43553-0004 HUMAN OTC DRUG ALOE VESTA CLEAR BARRIER PETROLATUM SPRAY TOPICAL 20131220 OTC MONOGRAPH FINAL part347 ConvaTec Inc. PETROLATUM 36 g/100g N 20181231 43553-0007_60f2fba6-8e61-102b-e053-2a91aa0ac82b 43553-0007 HUMAN OTC DRUG SENSI CARE CLEAR ZINC DIMETHICONE, ZINC OXIDE CREAM TOPICAL 20140612 OTC MONOGRAPH FINAL part347 ConvaTec Inc. DIMETHICONE; ZINC OXIDE 5; 5 g/100g; g/100g N 20181231 43553-1000_60dfeda0-e740-1762-e053-2a91aa0a7380 43553-1000 HUMAN OTC DRUG Sensi Care Incontinence Wipes DIMETHICONE CLOTH TOPICAL 20161019 OTC MONOGRAPH FINAL part347 ConvaTec Inc. DIMETHICONE 3 g/100g N 20181231 43553-3244_5f94fd2e-b803-4b42-885d-f25cb63297db 43553-3244 HUMAN OTC DRUG SENSI CARE MOISTURIZING BODY PETROLATUM CREAM TOPICAL 19980415 OTC MONOGRAPH FINAL part347 ConvaTec, Inc. PETROLATUM; DIMETHICONE 300; 10 mg/g; mg/g N 20181231 43553-3248_9318e568-74d8-4589-84da-f76131ecbf2c 43553-3248 HUMAN OTC DRUG ALOE VESTA SKIN CONDITIONER SKIN CONDITIONER LOTION TOPICAL 19980415 OTC MONOGRAPH FINAL part347 ConvaTec, Inc. DIMETHICONE .03 mg/mL N 20181231 43553-3249_60dfdbea-a3e9-cee4-e053-2991aa0a5104 43553-3249 HUMAN OTC DRUG ALOE VESTA PROTECTIVE PETROLATUM OINTMENT TOPICAL 20010223 OTC MONOGRAPH FINAL part347 ConvaTec, Inc. PETROLATUM 430 mg/g N 20181231 43553-3251_3cc7fd25-d33f-41ea-8f0c-49402a01e386 43553-3251 HUMAN OTC DRUG ALOE VESTA ANTIFUNGAL MICONAZOLE NITRATE OINTMENT TOPICAL 19971003 OTC MONOGRAPH FINAL part333C ConvaTec, Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 43553-3256_60dff18d-9355-eae0-e053-2991aa0a75e4 43553-3256 HUMAN OTC DRUG SENSI CARE PROTECTIVE BARRIER PETROLATUM, ZINC OXIDE CREAM TOPICAL 20000105 OTC MONOGRAPH FINAL part347 ConvaTec Inc. PETROLATUM; ZINC OXIDE 490; 150 mg/g; mg/g N 20181231 43553-4134_c83c8a0d-a979-4024-9f02-01392449ecbc 43553-4134 HUMAN OTC DRUG ALOE VESTA PROTECTIVE BARRIER PETROLATUM SPRAY TOPICAL 20050113 OTC MONOGRAPH FINAL part347 ConvaTec, Inc. PETROLATUM 360 mg/g N 20181231 43555-020_868bf139-2f4c-478c-84ee-d8d3546eaa5b 43555-020 HUMAN PRESCRIPTION DRUG OXYGEN, COMPRESSED OXYGEN, COMPRESSED GAS RESPIRATORY (INHALATION) 20100802 UNAPPROVED MEDICAL GAS CLEAN-OX, INC OXYGEN 1 L/L N 20181231 43596-0001_fb098a50-da0c-4609-9983-577a69896601 43596-0001 HUMAN OTC DRUG LBEL DEFENSE 365 Daily Protective Facial SPF 50 HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20120325 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 5; 7; 5; 4; 6.24; 3.92 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 43596-0002_3728f4b5-7b55-476c-b03b-f108a69ce153 43596-0002 HUMAN OTC DRUG LBEL HYDRA CALME SPF 15 Intensive Moisturizing Facial OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120325 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 4 mL/100mL; mL/100mL; mL/100mL E 20171231 43596-0003_7def8495-7f74-4981-943c-a9f9aa0faf5e 43596-0003 HUMAN OTC DRUG LBEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Normal to Combination Skin OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120327 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 4 mL/100mL; mL/100mL; mL/100mL E 20171231 43596-0004_07071b9d-506e-4620-9cb9-04a754abd06c 43596-0004 HUMAN OTC DRUG LBEL RENOVANCE JOUR Daytime Face SPF 15 All Skin Types OCTINOXATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 3 g/100g; g/100g; g/100g E 20171231 43596-0005_28f26674-ce97-4c85-b3a0-392e79366e7f 43596-0005 HUMAN OTC DRUG LBEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face SPF 15 Normal To Dry Skin ENSULIZOLE, HOMOSALATE, OCTINOXATE, OXYBENZONE CREAM TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD ENSULIZOLE; HOMOSALATE; OCTINOXATE; OXYBENZONE 2; 2; 7.5; 4 g/100g; g/100g; g/100g; g/100g E 20171231 43596-0006_a4002681-ce35-45e9-8d57-7e71e9b5095b 43596-0006 HUMAN OTC DRUG LBEL SUPREMACIE NX JOUR Replenishing Daytime Face SPF 15 Normal To Oily Skin ENSULIZOLE, HOMOSALATE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD ENSULIZOLE; HOMOSALATE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 1.5; 1; 7.5; 4.5; 1.17 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 43596-0007_f3d8ea25-315a-4287-8fc0-cb2766f5eccf 43596-0007 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 1 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0008_c55c89f9-f25e-4962-88d0-5fc16123c9f8 43596-0008 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 2 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0009_78947038-1060-4ba9-8335-c477a97bfe21 43596-0009 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 3 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0010_15ff9a2f-54ac-4546-8ac7-735c7be2b2c1 43596-0010 HUMAN OTC DRUG LBEL EFET PARFAIT Spots Reducing Effect Foundation SPF 18 - CLAIRE 4 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0011_626744ac-3145-45b3-829d-83c6fa322017 43596-0011 HUMAN OTC DRUG LBEL EFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 5 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0012_b36dfc42-f5e8-4560-accc-d83f0940bac5 43596-0012 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 6 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0013_25b1911b-8d5d-4266-be09-de1a8e110679 43596-0013 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 7 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0014_f53f92b2-c555-47f5-99cb-3d0d5bb8465d 43596-0014 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0015_3831ffdb-ece4-4c1b-a493-210b542fea50 43596-0015 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 6A OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0016_1c10361b-b4d9-4936-bde7-fc16f1070d7a 43596-0016 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - MEDIUM 6B OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0017_f34a5835-5cf6-4907-92c2-cbd90691d350 43596-0017 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8A OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0018_250f5093-29c3-46ea-9d99-4c98a1671439 43596-0018 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8B OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0019_6388c4dc-6d8f-4d06-885c-84fe0c08f912 43596-0019 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 8C OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0020_9674a2d4-f1a7-4161-88bc-c0533b1d7288 43596-0020 HUMAN OTC DRUG LBEL EFFET PARFAIT Spots Reducing Effect Foundation SPF 18 - OBSCURE 10 OCTINOXATE, OXYBENZONE EMULSION TOPICAL 20120324 OTC MONOGRAPH FINAL part352 Ventura Corporation, LTD OCTINOXATE; OXYBENZONE 7.5; 2 g/100g; g/100g E 20171231 43596-0021_b2719932-5125-4491-8c56-1a6dac4039ef 43596-0021 HUMAN OTC DRUG Esika Men Dandruff Maximum Strength PYRITHIONE ZINC SHAMPOO TOPICAL 20121003 OTC MONOGRAPH FINAL part358H Ventura Corporation Limited PYRITHIONE ZINC 5.28 mg/mL E 20171231 43596-0022_24e804c1-1f96-4ead-a56c-7bed8e766f6c 43596-0022 HUMAN OTC DRUG Esika Passion Musk Antiperspirant Roll-On Deodorant ALUMINUM SESQUICHLOROHYDRATE CREAM TOPICAL 20120820 OTC MONOGRAPH FINAL part350 Ventura Corporation Limited ALUMINUM SESQUICHLOROHYDRATE 13.6 mg/100mL E 20171231 43596-0023_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0023 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 VINO CAUTIVANTE - PURPLE OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0024_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0024 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 PIMIENTA CALIENTE - RED OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0025_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0025 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 ROJO GLAM - RED OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0026_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0026 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 ROJO PASION - RED OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0027_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0027 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 VINO DESEO - PURPLE OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0028_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0028 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 FUCSIA TENTACION - PINK OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0029_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0029 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 FUCSIA DELIRIO - PINK OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0030_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0030 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 FUCSIA VIBRANTE - PINK OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0031_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0031 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 ROSA VIVA - PINK OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0032_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0032 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 CORAL ENSUENO - RED OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0033_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0033 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 MARRON BAMBU - BROWN OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0034_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0034 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 ROSA FIORELLE - PINK OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0035_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0035 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 NATURAL DUNE - BEIGE OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0036_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0036 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 ROJO FIESTA - RED OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0037_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0037 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 NUDE Cream - BEIGE OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0038_684a727b-3d0f-4f79-a79e-f720fe128e55 43596-0038 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 CLAIRE 1 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 43596-0039_684a727b-3d0f-4f79-a79e-f720fe128e55 43596-0039 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 CLAIRE 2 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 43596-0040_684a727b-3d0f-4f79-a79e-f720fe128e55 43596-0040 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 CLAIRE 3 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 43596-0041_684a727b-3d0f-4f79-a79e-f720fe128e55 43596-0041 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 CLAIRE 4 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 43596-0042_684a727b-3d0f-4f79-a79e-f720fe128e55 43596-0042 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 MEDIUM 5 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 43596-0043_684a727b-3d0f-4f79-a79e-f720fe128e55 43596-0043 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 MEDIUM 6 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 43596-0044_684a727b-3d0f-4f79-a79e-f720fe128e55 43596-0044 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 MEDIUM 7 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 43596-0045_684a727b-3d0f-4f79-a79e-f720fe128e55 43596-0045 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 OBSCURE 8 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 43596-0046_684a727b-3d0f-4f79-a79e-f720fe128e55 43596-0046 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 OBSCURE 9 - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 43596-0047_684a727b-3d0f-4f79-a79e-f720fe128e55 43596-0047 HUMAN OTC DRUG LBEL CONCENTRE TOTAL BASE SERUM ULTRA-FLUID FOUNDATION SPF 25 TONO HUT - BEIGE Octinoxate and Zinc Oxide LIQUID TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .072 g/mL; g/mL N 20181231 43596-0048_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0048 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 NUDE MOCCHA - BEIGE OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0049_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0049 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 FUCSIA SUBLIME - PINK OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0050_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0050 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 MARRON HAVANA - BROWN OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0051_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0051 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 MARRON FANATIC - BROWN OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0052_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0052 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 NUDE ROSE- BEIGE OCTINOXATE LIPSTICK TOPICAL 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .068 g/g N 20181231 43596-0053_ad55c960-b20d-432f-8f69-da449b711fe6 43596-0053 HUMAN OTC DRUG Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 OCTINOXATE KIT 20170127 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD N 20181231 43596-0054_ab40e923-55be-442d-bbdf-2a4d16c91e63 43596-0054 HUMAN OTC DRUG Esika Pro Compact High Definintion and Double Finish SPF 15 CLEAR 1 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide POWDER TOPICAL 20170416 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .0624; .049 g/g; g/g; g/g N 20181231 43596-0055_ab40e923-55be-442d-bbdf-2a4d16c91e63 43596-0055 HUMAN OTC DRUG Esika Pro Compact High Definintion and Double Finish SPF 15 CLEAR 2 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide POWDER TOPICAL 20170416 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .0624; .049 g/g; g/g; g/g N 20181231 43596-0056_ab40e923-55be-442d-bbdf-2a4d16c91e63 43596-0056 HUMAN OTC DRUG Esika Pro Compact High Definintion and Double Finish SPF 15 MEDIUM 1 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide POWDER TOPICAL 20170416 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .0624; .049 g/g; g/g; g/g N 20181231 43596-0057_ab40e923-55be-442d-bbdf-2a4d16c91e63 43596-0057 HUMAN OTC DRUG Esika Pro Compact High Definintion and Double Finish SPF 15 MEDIUM 2 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide POWDER TOPICAL 20170416 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .0624; .049 g/g; g/g; g/g N 20181231 43596-0058_ab40e923-55be-442d-bbdf-2a4d16c91e63 43596-0058 HUMAN OTC DRUG Esika Pro Compact High Definintion and Double Finish SPF 15 MEDIUM 3 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide POWDER TOPICAL 20170416 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .0624; .049 g/g; g/g; g/g N 20181231 43596-0059_ab40e923-55be-442d-bbdf-2a4d16c91e63 43596-0059 HUMAN OTC DRUG Esika Pro Compact High Definintion and Double Finish SPF 15 MEDIUM 4 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide POWDER TOPICAL 20170416 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .0624; .049 g/g; g/g; g/g N 20181231 43596-0060_ab40e923-55be-442d-bbdf-2a4d16c91e63 43596-0060 HUMAN OTC DRUG Esika Pro Compact High Definintion and Double Finish SPF 15 MEDIUM 5 - BEIGE Octinoxate, Titanium Dioxide, and Zinc Oxide POWDER TOPICAL 20170416 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .03; .0624; .049 g/g; g/g; g/g N 20181231 43596-0061_766c5e69-503f-4dfd-9bf5-6d330a7aed64 43596-0061 HUMAN OTC DRUG Cy Go Nude Base Ligera Acabo Natural Cobertura Media FPS 20 Octinoxate and Zinc Oxide CREAM TOPICAL 20170419 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .06; .06 g/g; g/g N 20181231 43596-0062_a645726e-22eb-40dc-a72b-10ec3e47ef82 43596-0062 HUMAN OTC DRUG LBEL Defense Total Compact Suncreen SPF 50 For Face - Matte Finish OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20170418 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; OCTOCRYLENE; ZINC OXIDE .07; .05; .1666 g/g; g/g; g/g N 20181231 43596-0064_3015f6cd-44c2-4f21-9418-3e34b8536c34 43596-0064 HUMAN OTC DRUG CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 Red/Red Octinoxate LIPSTICK TOPICAL 20170824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 43596-0065_3015f6cd-44c2-4f21-9418-3e34b8536c34 43596-0065 HUMAN OTC DRUG CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 Apple/Red Octinoxate LIPSTICK TOPICAL 20170824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 43596-0066_3015f6cd-44c2-4f21-9418-3e34b8536c34 43596-0066 HUMAN OTC DRUG CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 Rose/Red Octinoxate LIPSTICK TOPICAL 20170824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 43596-0067_3015f6cd-44c2-4f21-9418-3e34b8536c34 43596-0067 HUMAN OTC DRUG CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 Fucsia/Red Octinoxate LIPSTICK TOPICAL 20170824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 43596-0068_3015f6cd-44c2-4f21-9418-3e34b8536c34 43596-0068 HUMAN OTC DRUG CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 Grape/Red Octinoxate LIPSTICK TOPICAL 20170824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 43596-0069_3015f6cd-44c2-4f21-9418-3e34b8536c34 43596-0069 HUMAN OTC DRUG CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 Chocolate/Brown Octinoxate LIPSTICK TOPICAL 20170824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 43596-0070_3015f6cd-44c2-4f21-9418-3e34b8536c34 43596-0070 HUMAN OTC DRUG CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 Marsala/Red Octinoxate LIPSTICK TOPICAL 20170824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 43596-0071_3015f6cd-44c2-4f21-9418-3e34b8536c34 43596-0071 HUMAN OTC DRUG CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 Rose Nude/Red Octinoxate LIPSTICK TOPICAL 20170824 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE .075 g/g N 20181231 43596-0078_4bb671f8-0aa3-46d4-9344-9581a4548950 43596-0078 HUMAN OTC DRUG CY BB Facial Hidratante con Color FPS 25 Multibeneficios OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20171201 OTC MONOGRAPH FINAL part352 Ventura Corporation LTD OCTINOXATE; ZINC OXIDE .07; .084 g/g; g/g N 20181231 43598-003_0756200b-9953-58d9-b495-409d3cbf8c1d 43598-003 HUMAN PRESCRIPTION DRUG AUGMENTIN ES-600 amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20121031 NDA NDA050755 Dr Reddys Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-004_81f11e22-8d19-4974-87d5-aa983d5ea945 43598-004 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 250; 62.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-006_81f11e22-8d19-4974-87d5-aa983d5ea945 43598-006 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19901022 NDA NDA050564 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; 1/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-012_81f11e22-8d19-4974-87d5-aa983d5ea945 43598-012 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 125; 31.25 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-018_81f11e22-8d19-4974-87d5-aa983d5ea945 43598-018 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19901022 NDA NDA050564 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-020_403f620b-fbf3-3bb3-88e7-c69ee5c9527d 43598-020 HUMAN PRESCRIPTION DRUG AUGMENTIN XR amoxicillin and clavulanate potassium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030911 NDA NDA050785 Dr Reddys Laboratories Inc AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM 562.5; 437.5; 62.5 mg/1; mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-021_81f11e22-8d19-4974-87d5-aa983d5ea945 43598-021 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19961002 NDA NDA050720 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; 1/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-164_dc014b23-2115-a128-e369-7ac7ee4127a6 43598-164 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20131210 ANDA ANDA076255 Dr. Reddy's Laboratories Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 43598-165_dc014b23-2115-a128-e369-7ac7ee4127a6 43598-165 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20131210 ANDA ANDA076255 Dr. Reddy's Laboratories Inc. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 43598-166_dc014b23-2115-a128-e369-7ac7ee4127a6 43598-166 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20131210 ANDA ANDA076255 Dr. Reddy's Laboratories Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 43598-203_15441e10-a11b-457f-bfd4-e05604691500 43598-203 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20010622 NDA NDA050755 Dr Reddys Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-204_4291f971-d386-411e-8d06-95be682a3961 43598-204 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050575 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 250; 62.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-205_61fe229e-051a-43da-9fa8-e82a1c16b63c 43598-205 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin CAPSULE ORAL 19790802 ANDA ANDA062216 Dr Reddys Laboratories Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43598-206_4291f971-d386-411e-8d06-95be682a3961 43598-206 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19901022 NDA NDA050564 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-207_989011b4-ea16-4404-883d-e2a6ad18b59c 43598-207 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin POWDER, FOR SUSPENSION ORAL 19990415 NDA NDA050760 Dr Reddys Laboratories Inc AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43598-208_4291f971-d386-411e-8d06-95be682a3961 43598-208 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050725 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-209_61fe229e-051a-43da-9fa8-e82a1c16b63c 43598-209 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin POWDER, FOR SUSPENSION ORAL 19791127 ANDA ANDA062226 Dr Reddys Laboratories Inc AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43598-210_1b9eafb8-74a8-595a-9822-f8fed0a5c542 43598-210 HUMAN PRESCRIPTION DRUG SSD Cream Silver Sulfadiazine CREAM TOPICAL 20110504 NDA NDA018578 Dr Reddys Laboratories Inc SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 43598-213_4291f971-d386-411e-8d06-95be682a3961 43598-213 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050725 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-218_4291f971-d386-411e-8d06-95be682a3961 43598-218 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19901022 NDA NDA050564 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-219_989011b4-ea16-4404-883d-e2a6ad18b59c 43598-219 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 Dr Reddys Laboratories Inc AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43598-220_281d6c99-708d-bd90-e14e-dd9e6749db4b 43598-220 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Extended Release amoxicillin and clavulanate potassium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030911 NDA NDA050785 Dr. Reddy's Laboratories Inc AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM 562.5; 437.5; 62.5 mg/1; mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-221_4291f971-d386-411e-8d06-95be682a3961 43598-221 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19961002 NDA NDA050720 Dr. Reddy's Laboratories Inc AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43598-222_61fe229e-051a-43da-9fa8-e82a1c16b63c 43598-222 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin POWDER, FOR SUSPENSION ORAL 19791127 ANDA ANDA062226 Dr Reddys Laboratories Inc AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43598-223_989011b4-ea16-4404-883d-e2a6ad18b59c 43598-223 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin POWDER, FOR SUSPENSION ORAL 19990415 NDA NDA050760 Dr Reddys Laboratories Inc AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43598-224_989011b4-ea16-4404-883d-e2a6ad18b59c 43598-224 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 Dr Reddys Laboratories Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43598-225_61fe229e-051a-43da-9fa8-e82a1c16b63c 43598-225 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin CAPSULE ORAL 19790802 ANDA ANDA062216 Dr Reddys Laboratories Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43598-258_efa4eb2a-8ec3-9582-f62d-d52607e1ded5 43598-258 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION INTRAVENOUS 20141110 ANDA ANDA204193 Dr. Reddy's Laboratories Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 43598-259_efa4eb2a-8ec3-9582-f62d-d52607e1ded5 43598-259 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION INTRAVENOUS 20141110 ANDA ANDA204193 Dr. Reddy's Laboratories Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 43598-283_a141b60d-2a3c-34dc-969c-c1930a152b97 43598-283 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL INTRAVENOUS 20170522 ANDA ANDA208657 Dr. Reddy's Laboratories Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 43598-303_cf454159-420b-ba16-3110-e72184b6aa16 43598-303 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20121025 ANDA ANDA090061 Dr Reddys Laboratories Inc FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 43598-305_232e689b-eac0-961d-c96e-1497a5c33e9b 43598-305 HUMAN PRESCRIPTION DRUG Azacitidine Azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20130919 ANDA ANDA201537 Dr. Reddy's Laboratories Inc. AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 43598-309_d6d1f0d8-3df4-1b80-d545-39685231a926 43598-309 HUMAN PRESCRIPTION DRUG Clofarabine Clofarabine INJECTION INTRAVENOUS 20171108 ANDA ANDA205375 Dr.Reddy's Laboratories Inc CLOFARABINE 1 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 43598-313_66373a4d-3a95-1804-2983-fc95cdee7611 43598-313 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-314_66373a4d-3a95-1804-2983-fc95cdee7611 43598-314 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-315_66373a4d-3a95-1804-2983-fc95cdee7611 43598-315 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-316_66373a4d-3a95-1804-2983-fc95cdee7611 43598-316 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-317_66373a4d-3a95-1804-2983-fc95cdee7611 43598-317 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-318_66373a4d-3a95-1804-2983-fc95cdee7611 43598-318 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-319_66373a4d-3a95-1804-2983-fc95cdee7611 43598-319 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-320_66373a4d-3a95-1804-2983-fc95cdee7611 43598-320 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-321_66373a4d-3a95-1804-2983-fc95cdee7611 43598-321 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-322_66373a4d-3a95-1804-2983-fc95cdee7611 43598-322 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-323_66373a4d-3a95-1804-2983-fc95cdee7611 43598-323 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium Amlodipine besylate and Atorvastatin calcium TABLET, FILM COATED ORAL 20140317 ANDA ANDA203874 Dr. Reddy's Laboratories Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-330_ce5d4c60-f7d1-cf67-e82d-cb6581ad7a3f 43598-330 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130819 ANDA ANDA091186 Dr. Reddy's Laboratories Inc. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 43598-331_1ffc9a13-15ce-f883-3df3-9db1fb567ff2 43598-331 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20130819 ANDA ANDA091363 Dr.Reddy's Laboratories Inc ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 43598-341_c98209e6-a607-a8c9-9db3-529b9a59752d 43598-341 HUMAN PRESCRIPTION DRUG clocortolone pivalate clocortolone pivalate CREAM TOPICAL 20140217 NDA AUTHORIZED GENERIC NDA017765 Dr. Reddy's Laboratories Inc CLOCORTOLONE PIVALATE .001 g/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43598-348_bf9728a8-848d-9fdc-1647-f11a11b45758 43598-348 HUMAN PRESCRIPTION DRUG Decitabine Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130711 ANDA ANDA203131 Dr.Reddy's Laboratories Inc DECITABINE 50 mg/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 43598-349_d41c647e-56dc-eaa6-2354-a73c79437cd5 43598-349 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20170325 ANDA ANDA208801 Dr. Reddy¿s Laboratories, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 43598-350_d41c647e-56dc-eaa6-2354-a73c79437cd5 43598-350 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20170325 ANDA ANDA208801 Dr. Reddy¿s Laboratories, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 43598-356_99046042-4056-953e-6a9f-82f722ed9e1b 43598-356 HUMAN PRESCRIPTION DRUG valganciclovir hydrochloride valganciclovir hydrochloride TABLET ORAL 20171212 ANDA ANDA206876 Dr. Reddy's Laboratories Inc VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 43598-390_6a2e6349-2ab7-abad-b09f-b310b0f5ca47 43598-390 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20140610 ANDA ANDA090060 Dr Reddys Laboratories Inc FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 43598-392_d62aeb19-ca7d-d5cf-3626-96a0b474d2da 43598-392 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride KIT INTRAVENOUS 20171218 ANDA ANDA203655 Dr.Reddy's Laboratories Inc N 20191231 43598-394_dff87316-586a-1a05-59a8-00a468f3ef9a 43598-394 HUMAN PRESCRIPTION DRUG Tetrabenazine Tetrabenazine TABLET ORAL 20180108 ANDA ANDA209284 Dr. Reddys Laboratories Inc TETRABENAZINE 12.5 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20191231 43598-395_dff87316-586a-1a05-59a8-00a468f3ef9a 43598-395 HUMAN PRESCRIPTION DRUG Tetrabenazine Tetrabenazine TABLET ORAL 20180108 ANDA ANDA209284 Dr. Reddys Laboratories Inc TETRABENAZINE 25 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20191231 43598-409_13c2f13e-32da-66f4-294e-a89c3f50a206 43598-409 HUMAN PRESCRIPTION DRUG levalbuterol inhalation levalbuterol inhalation 1.25mg/3mL SOLUTION RESPIRATORY (INHALATION) 20140916 ANDA ANDA078171 Dr. Reddy¿s Laboratories, Inc. LEVALBUTEROL 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 43598-410_13c2f13e-32da-66f4-294e-a89c3f50a206 43598-410 HUMAN PRESCRIPTION DRUG levalbuterol inhalation levalbuterol inhalation 0.63mg/3mL SOLUTION RESPIRATORY (INHALATION) 20140916 ANDA ANDA078171 Dr. Reddy¿s Laboratories, Inc. LEVALBUTEROL .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 43598-412_13c2f13e-32da-66f4-294e-a89c3f50a206 43598-412 HUMAN PRESCRIPTION DRUG levalbuterol inhalation levalbuterol inhalation 0.31mg/3mL SOLUTION RESPIRATORY (INHALATION) 20140916 ANDA ANDA078171 Dr. Reddy¿s Laboratories, Inc. LEVALBUTEROL .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 43598-427_90feb0e8-39f8-f0ae-e93f-47bec00cf189 43598-427 HUMAN PRESCRIPTION DRUG Decitabine Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141205 ANDA ANDA203131 Dr.Reddy's Laboratories Inc DECITABINE 50 mg/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 43598-431_32770e8c-63e6-8ec0-8e44-0c020144f657 43598-431 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 20161115 ANDA ANDA208326 Dr. Reddy's Laboratories, Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43598-435_91f7d356-54f1-5c86-7689-d7fd7d882ef7 43598-435 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET SUBLINGUAL 20160829 ANDA ANDA208191 Dr. Reddys Laboratories Inc NITROGLYCERIN .3 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 43598-436_91f7d356-54f1-5c86-7689-d7fd7d882ef7 43598-436 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET SUBLINGUAL 20160829 ANDA ANDA208191 Dr. Reddys Laboratories Inc NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 43598-437_91f7d356-54f1-5c86-7689-d7fd7d882ef7 43598-437 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET SUBLINGUAL 20160829 ANDA ANDA208191 Dr. Reddys Laboratories Inc NITROGLYCERIN .6 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 43598-445_64eab17d-ce0b-d5fa-2981-cc257f285a2c 43598-445 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM NICOTINE KIT TRANSDERMAL 20150514 NDA NDA020076 Dr. Reddy's Laboratories Limited N 20181231 43598-446_989c9103-793c-ba18-43b7-9debc7bb11a2 43598-446 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150514 NDA NDA020076 Dr. Reddy's Laboratories Inc. NICOTINE 7 mg/24h N 20181231 43598-447_989c9103-793c-ba18-43b7-9debc7bb11a2 43598-447 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150514 NDA NDA020076 Dr. Reddy's Laboratories Inc. NICOTINE 14 mg/24h N 20181231 43598-448_989c9103-793c-ba18-43b7-9debc7bb11a2 43598-448 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150514 NDA NDA020076 Dr. Reddy's Laboratories Inc. NICOTINE 21 mg/24h N 20181231 43598-465_498c1689-7f39-4bf1-9273-eb3229878342 43598-465 HUMAN PRESCRIPTION DRUG Azacitidine Azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20150619 ANDA ANDA201537 Dr. Reddy's Laboratories Inc. AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 43598-494_3d7a25f3-6ada-20d1-d60a-9eca1f37facd 43598-494 HUMAN PRESCRIPTION DRUG Naproxen sodium Naproxen sodium TABLET, FILM COATED ORAL 20160426 ANDA ANDA078486 Dr. Reddy's Laboratories Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43598-495_3d7a25f3-6ada-20d1-d60a-9eca1f37facd 43598-495 HUMAN PRESCRIPTION DRUG Naproxen sodium Naproxen sodium TABLET, FILM COATED ORAL 20160426 ANDA ANDA078486 Dr. Reddy's Laboratories Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 43598-505_6ce25706-e8c6-4fc0-88d6-8a0900297bb5 43598-505 HUMAN PRESCRIPTION DRUG Raloxifene hydrochloride Raloxifene hydrochloride TABLET, FILM COATED ORAL 20161012 ANDA ANDA206384 Dr.Reddy’s Laboratories Inc RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 43598-509_610e2c6a-d1a6-a45f-2d7e-9e7089ae6bf6 43598-509 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20151210 ANDA ANDA078279 Dr. Reddy's Laboratories Inc ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43598-510_610e2c6a-d1a6-a45f-2d7e-9e7089ae6bf6 43598-510 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20151210 ANDA ANDA078279 Dr. Reddy's Laboratories Inc ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 43598-536_532fddb2-a4b9-4289-b36c-336ae6287441 43598-536 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160801 ANDA ANDA205794 Dr. Reddy’s Laboratories Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43598-537_532fddb2-a4b9-4289-b36c-336ae6287441 43598-537 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160801 ANDA ANDA205794 Dr. Reddy’s Laboratories Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43598-538_532fddb2-a4b9-4289-b36c-336ae6287441 43598-538 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160801 ANDA ANDA205794 Dr. Reddy’s Laboratories Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43598-539_7c7a3d89-29a7-e845-a140-b4d1e4139ebb 43598-539 HUMAN PRESCRIPTION DRUG Minolira Minolira TABLET, EXTENDED RELEASE ORAL 20170808 NDA NDA209269 Dr. Reddys Laboratories Inc MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 43598-540_7c7a3d89-29a7-e845-a140-b4d1e4139ebb 43598-540 HUMAN PRESCRIPTION DRUG Minolira Minolira TABLET, EXTENDED RELEASE ORAL 20170808 NDA NDA209269 Dr. Reddys Laboratories Inc MINOCYCLINE HYDROCHLORIDE 105 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 43598-541_a141b60d-2a3c-34dc-969c-c1930a152b97 43598-541 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL INTRAVENOUS 20170522 ANDA ANDA208657 Dr. Reddy's Laboratories Inc DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 43598-550_5daef658-d5ab-4388-aac5-423cb81b3e1f 43598-550 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20160617 ANDA ANDA206382 Dr. Reddy’s Laboratories Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43598-551_5daef658-d5ab-4388-aac5-423cb81b3e1f 43598-551 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20160617 ANDA ANDA206382 Dr. Reddy’s Laboratories Inc. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43598-552_5daef658-d5ab-4388-aac5-423cb81b3e1f 43598-552 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20160617 ANDA ANDA206382 Dr. Reddy’s Laboratories Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43598-553_5daef658-d5ab-4388-aac5-423cb81b3e1f 43598-553 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20160617 ANDA ANDA206382 Dr. Reddy’s Laboratories Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 43598-554_51eb4bb8-42bc-4178-bcbc-3f7d1db85498 43598-554 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160929 ANDA ANDA206383 Dr.Reddy’s Laboratories Inc ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 43598-555_51eb4bb8-42bc-4178-bcbc-3f7d1db85498 43598-555 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160929 ANDA ANDA206383 Dr.Reddy’s Laboratories Inc ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 43598-556_51eb4bb8-42bc-4178-bcbc-3f7d1db85498 43598-556 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160929 ANDA ANDA206383 Dr.Reddy’s Laboratories Inc ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 43598-557_51eb4bb8-42bc-4178-bcbc-3f7d1db85498 43598-557 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160929 ANDA ANDA206383 Dr.Reddy’s Laboratories Inc ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 43598-558_51eb4bb8-42bc-4178-bcbc-3f7d1db85498 43598-558 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160929 ANDA ANDA206383 Dr.Reddy’s Laboratories Inc ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 43598-559_51eb4bb8-42bc-4178-bcbc-3f7d1db85498 43598-559 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160929 ANDA ANDA206383 Dr.Reddy’s Laboratories Inc ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 43598-562_1fc85c0a-9af3-22b4-4a6b-d1cd637dc163 43598-562 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION, SOLUTION INTRAVENOUS 20160906 ANDA ANDA204910 Dr. Reddy's Laboratories Inc PARICALCITOL 5 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 43598-563_1fc85c0a-9af3-22b4-4a6b-d1cd637dc163 43598-563 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION, SOLUTION INTRAVENOUS 20160906 ANDA ANDA204910 Dr. Reddy's Laboratories Inc PARICALCITOL 2 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 43598-564_1fc85c0a-9af3-22b4-4a6b-d1cd637dc163 43598-564 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION, SOLUTION INTRAVENOUS 20160906 ANDA ANDA204910 Dr. Reddy's Laboratories Inc PARICALCITOL 5 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 43598-565_1fc85c0a-9af3-22b4-4a6b-d1cd637dc163 43598-565 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION, SOLUTION INTRAVENOUS 20160906 ANDA ANDA204910 Dr. Reddy's Laboratories Inc PARICALCITOL 5 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 43598-567_791da49e-53fb-deb1-2792-5c649d12ff7e 43598-567 HUMAN PRESCRIPTION DRUG Trimipramine Maleate Trimipramine Maleate CAPSULE ORAL 20170828 ANDA ANDA077361 Dr. Reddy Laboratories, Inc. TRIMIPRAMINE MALEATE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 43598-568_791da49e-53fb-deb1-2792-5c649d12ff7e 43598-568 HUMAN PRESCRIPTION DRUG Trimipramine Maleate Trimipramine Maleate CAPSULE ORAL 20170828 ANDA ANDA077361 Dr. Reddy Laboratories, Inc. TRIMIPRAMINE MALEATE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 43598-569_791da49e-53fb-deb1-2792-5c649d12ff7e 43598-569 HUMAN PRESCRIPTION DRUG Trimipramine Maleate Trimipramine Maleate CAPSULE ORAL 20170828 ANDA ANDA077361 Dr. Reddy Laboratories, Inc. TRIMIPRAMINE MALEATE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 43598-583_84298866-72ea-5913-9946-d64036788662 43598-583 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20170426 ANDA ANDA200909 Dr.Reddys Laboratories Inc EZETIMIBE; SIMVASTATIN 10; 10 mg/1; mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 43598-584_84298866-72ea-5913-9946-d64036788662 43598-584 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20170426 ANDA ANDA200909 Dr.Reddys Laboratories Inc EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-585_84298866-72ea-5913-9946-d64036788662 43598-585 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20170426 ANDA ANDA200909 Dr.Reddys Laboratories Inc EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-586_84298866-72ea-5913-9946-d64036788662 43598-586 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20170426 ANDA ANDA200909 Dr.Reddys Laboratories Inc EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 43598-606_9b361d78-4a41-81be-6615-89f4ed45d219 43598-606 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium Fondaparinux Sodium INJECTION SUBCUTANEOUS 20170727 ANDA ANDA091316 Dr. Reddy's Laboratories Inc. FONDAPARINUX SODIUM 10 mg/.8mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 43598-607_9b361d78-4a41-81be-6615-89f4ed45d219 43598-607 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium Fondaparinux Sodium INJECTION SUBCUTANEOUS 20170727 ANDA ANDA091316 Dr. Reddy's Laboratories Inc. FONDAPARINUX SODIUM 2.5 mg/.5mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 43598-608_9b361d78-4a41-81be-6615-89f4ed45d219 43598-608 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium Fondaparinux Sodium INJECTION SUBCUTANEOUS 20170727 ANDA ANDA091316 Dr. Reddy's Laboratories Inc. FONDAPARINUX SODIUM 5 mg/.4mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 43598-609_9b361d78-4a41-81be-6615-89f4ed45d219 43598-609 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium Fondaparinux Sodium INJECTION SUBCUTANEOUS 20170727 ANDA ANDA091316 Dr. Reddy's Laboratories Inc. FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 43598-610_38958960-47de-695f-78dd-20a5d3ddfb64 43598-610 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION INTRAVENOUS 20170822 ANDA ANDA204193 Dr. Reddy's Laboratories Inc. DOCETAXEL 80 mg/4mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 43598-611_38958960-47de-695f-78dd-20a5d3ddfb64 43598-611 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION INTRAVENOUS 20170822 ANDA ANDA204193 Dr. Reddy's Laboratories Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 43598-655_347f3bb6-455a-4772-9c27-c70b288ed947 43598-655 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170412 ANDA ANDA207479 Dr Reddys Laboratories Inc BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43598-656_347f3bb6-455a-4772-9c27-c70b288ed947 43598-656 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170412 ANDA ANDA207479 Dr Reddys Laboratories Inc BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 43598-673_9476304d-05fd-4585-b955-372b29c19c86 43598-673 HUMAN PRESCRIPTION DRUG Cefixime Cefixime POWDER, FOR SUSPENSION ORAL 20170803 ANDA ANDA206938 Dr. Reddy’s Laboratories, Inc CEFIXIME 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43598-674_9476304d-05fd-4585-b955-372b29c19c86 43598-674 HUMAN PRESCRIPTION DRUG Cefixime Cefixime POWDER, FOR SUSPENSION ORAL 20170803 ANDA ANDA206938 Dr. Reddy’s Laboratories, Inc CEFIXIME 200 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 43598-678_4f2557db-fb54-b627-e53a-f400b66d42a8 43598-678 HUMAN PRESCRIPTION DRUG AZACITIDINE AZACITIDINE AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20171213 ANDA ANDA207518 Dr. Reddy's Laboratories Inc. AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 43599-001_1316916a-0f1b-4c6c-e054-00144ff88e88 43599-001 HUMAN OTC DRUG NAMMAN MUAY Athletes Pain Relieving MENTHOL, METHYL SALICYLATE LINIMENT TOPICAL 20110610 OTC MONOGRAPH NOT FINAL part348 Devakam Apothecary Hall, Co, Ltd. MENTHOL; METHYL SALICYLATE 12.5; 310 mg/mL; mg/mL E 20171231 43617-3415_30c41d95-0796-4904-98b2-36655e8b6fbc 43617-3415 HUMAN OTC DRUG LANOCREME HYDRATING DAY SPF15 AVOBENZONE, OXYBENZONE, OCTYL METHOXYCINNAMATE CREAM TOPICAL 20120430 OTC MONOGRAPH NOT FINAL part352 Lanocorp Pacific Ltd AVOBENZONE; OXYBENZONE; OCTINOXATE 1.5; 1.5; 7.5 g/50g; g/50g; g/50g E 20171231 43617-3416_6036bdbc-2f41-4933-adfa-c821ad6f343e 43617-3416 HUMAN OTC DRUG By Nature Hydrating Day SPF 15 AVOBENZONE, OXYBENZONE, OCTYL METHOXYCINNAMATE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Lanocorp Pacific Ltd AVOBENZONE; OXYBENZONE; OCTINOXATE 1.5; 1.5; 7.5 g/50g; g/50g; g/50g E 20171231 43617-3417_c3e6ebb6-8f52-410d-a0bc-582de5226e1e 43617-3417 HUMAN OTC DRUG By Nature Daily Face Sunscreen Broad Spectrum SPF 30 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Lanocorp Pacific Ltd OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE; AVOBENZONE 75; 50; 45; 25 g/g; g/g; g/g; g/g E 20171231 43621-001_3c2bfcf2-3bdc-441b-8db9-d5ec80c6c9f3 43621-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900101 NDA NDA205712 DJB Gas Services, Inc OXYGEN 990 mL/L N 20181231 43621-002_b216948e-8da3-428a-9b22-3c245b9cfe50 43621-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20160304 NDA NDA205713 DJB Gas Services, Inc NITROGEN 990 mL/L N 20181231 43621-003_8d3a9e35-15b8-4675-99e7-204662c650d6 43621-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20160912 NDA NDA205704 DJB Gas Services, Inc NITROUS OXIDE 990 mL/L N 20181231 43638-002_2e918723-0605-01e6-e054-00144ff88e88 43638-002 HUMAN OTC DRUG Day Moisturizer SPF 15 Octocrylene Butyl Methoxydibenzoyl Methane (Avobenzone) CREAM TOPICAL 20160314 OTC MONOGRAPH FINAL part352 E.L. Erman Cosmetic Manufacturing Ltd. OCTOCRYLENE; AVOBENZONE 2.5; 1.5 mg/100mg; mg/100mg E 20171231 43645-112_6c90e09c-fb30-4508-87a2-c55d3a670d1d 43645-112 HUMAN OTC DRUG Miconole Miconazole Nitrate CREAM TOPICAL 20131015 OTC MONOGRAPH FINAL part333C Option Labs MICONAZOLE NITRATE 20 mg/g E 20171231 43689-0001_f9e95868-da01-483c-a753-b7f87cda8ec1 43689-0001 HUMAN OTC DRUG Urinary Incontinence Relief Causticum, Natrum muriaticum, Nus vomica, Pulsatilla, Sepia, Staphysagria, Thuja occidentalis, TABLET ORAL 20120717 UNAPPROVED HOMEOPATHIC The Magni Company CAUSTICUM; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12; 12 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 N 20181231 43689-0002_828d2f86-655a-44f8-b183-f46dfcdfdd29 43689-0002 HUMAN OTC DRUG Sleep Assist Chamomilla, Coffea cruda, Avena sativa, Nux Vomica, Passiflora incarnata, TABLET, ORALLY DISINTEGRATING ORAL 20120910 UNAPPROVED HOMEOPATHIC The Magni Company MATRICARIA RECUTITA; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP 4; 4; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 43689-0003_756826af-8731-4c1c-9a43-58c48c1c0948 43689-0003 HUMAN OTC DRUG Fibromyalgia Relief Aconitum Napellus, Arsenicum Album, Belladonna, Coniinum, Gelsemium Sempervirens, Hypericum Perforatum, Kali Bichromicum TABLET ORAL 20121011 UNAPPROVED HOMEOPATHIC The Magni Company ARSENIC TRIOXIDE; ACONITUM NAPELLUS; ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; CONIINE; POTASSIUM DICHROMATE; LACTIC ACID, DL-; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF; URIC ACID 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_X]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg N 20181231 43689-0004_4ca1e98c-f14d-4f45-8ed8-6fc675318752 43689-0004 HUMAN OTC DRUG Leg Cramp Relief Causticum, Colocynthis, Cuprum Metallicum, Magnesia Phosphorica, Phytolacca Decandra, Rhus Tox, Stannum Metallicum, Veratrum Album TABLET ORAL 20121010 UNAPPROVED HOMEOPATHIC The Magni Company CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; TIN; VERATRUM ALBUM ROOT 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 43689-0005_74223fc2-3268-4d27-b08b-11a37abc172d 43689-0005 HUMAN OTC DRUG Restless Legs Relief Aconitum Napellus, Gnaphalium Polycephalum, Ledum Palustre, Magnesia Phosphorica, Rhus Tox, Viscum Album TABLET ORAL 20130326 20210211 UNAPPROVED HOMEOPATHIC The Magni Company ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 6; 4; 6; 6; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 43689-0007_191f3bd1-b35e-4236-8492-57228d8d579a 43689-0007 HUMAN OTC DRUG Sciatica Relief Capsicum annuum, Colocynthis, Gnaphalium polycephalum, Magnesia phosphorica, TABLET ORAL 20121011 UNAPPROVED HOMEOPATHIC Magni Company CAPSICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 43689-0009_624c1635-0cca-499a-b2d6-ef58f6bd41d0 43689-0009 HUMAN OTC DRUG Tinnitus Relief Calcarea Carbonica, Chininum Sulphuricum, Kali Carbonicum, Lycopodium Clavatum, Salicylicum Acidum TABLET ORAL 20120816 UNAPPROVED HOMEOPATHIC The Magni Company OYSTER SHELL CALCIUM CARBONATE, CRUDE; QUININE SULFATE; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SALICYLIC ACID 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 43689-0010_9fd17902-3146-4545-8ead-7c6374f2cc31 43689-0010 HUMAN OTC DRUG Migraine Relief not applicable TABLET, ORALLY DISINTEGRATING ORAL 20140717 UNAPPROVED HOMEOPATHIC The Magni Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; BLACK COHOSH; ARABICA COFFEE BEAN; NITROGLYCERIN; IRIS VERSICOLOR ROOT; SODIUM CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 6; 6; 3; 6; 3; 12; 6; 6; 3; 3 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 43689-0013_ddf36a04-5c34-4877-a83e-93c811fbb681 43689-0013 HUMAN OTC DRUG Leg and Back Pain Relief Capsicum Annuum, Colocynthis, Gnaphalium Polycephalum, Magnesia Phosphorica TABLET ORAL 20150611 UNAPPROVED HOMEOPATHIC The Magni Company CAPSICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 43689-0014_09207789-b929-4e7d-a9e6-573b9e4ee350 43689-0014 HUMAN OTC DRUG Ringing Ear Relief Calcarea Carbonica, Chininum Sulphuricum, Kali Carbonicum, Lycopodium Clavatum, Salicylicum Acidum TABLET ORAL 20150728 20210203 UNAPPROVED HOMEOPATHIC The Magni Company OYSTER SHELL CALCIUM CARBONATE, CRUDE; QUININE SULFATE; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SALICYLIC ACID 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 43689-0015_d64132c5-74be-42f4-867b-03e0fda1215d 43689-0015 HUMAN OTC DRUG Pain and Fatigue Relief Aconitum Napellus, Arsenicum Album, Belladonna, Coniinum, Gelsemium Sempervirens, Hypericum Perforatum, Kali Bichromicum, Lacticum Acidum, Phosphoricum Acidum, Rhus Tox, Uricum Acidum TABLET ORAL 20150612 UNAPPROVED HOMEOPATHIC The Magni Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CONIINE; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM DICHROMATE; LACTIC ACID, DL-; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF; URIC ACID 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 43689-0016_41a8607c-f008-4995-a916-10548e9ddf42 43689-0016 HUMAN OTC DRUG Bladder Relief Causticum, Natrum Muriaticum, Nux Vomica, Pulsatilla (Vulgaris), Sepia, Staphysagria, Thuja Occidentalis TABLET ORAL 20150612 UNAPPROVED HOMEOPATHIC Magni Company CAUSTICUM; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 43689-0017_79411166-f92e-4457-97c2-eb179f9700e6 43689-0017 HUMAN OTC DRUG Migraine Relief Belladonna, Bryonia (Alba), Chamomilla, Cimicifuga Racemosa, Coffea Cruda, Glonoinum, Iris Versicolor, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis TABLET ORAL 20140717 UNAPPROVED HOMEOPATHIC The Magni Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; BLACK COHOSH; ARABICA COFFEE BEAN; NITROGLYCERIN; IRIS VERSICOLOR ROOT; SODIUM CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 6; 6; 3; 6; 3; 12; 6; 6; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 43689-0020_49ea97c1-0c33-4837-8fe0-643f84eacd17 43689-0020 HUMAN OTC DRUG Earache Relief Belladonna, Calcarea Carbonica, Chamomilla, Hepar Sulphuris Calcareum, Kali Bichromicum, Lycopodium Clavatum, Plantago Major, Pulsatilla (Vulgaris) TABLET ORAL 20160509 UNAPPROVED HOMEOPATHIC The Magni Company ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; PLANTAGO MAJOR; PULSATILLA VULGARIS 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 43689-0021_f17e0ce8-8c7a-4767-8d72-6b5e031ec31f 43689-0021 HUMAN OTC DRUG Relaxing Legs Aconitum Napellus, Gnaphalium Polycephalum, Ledum Palustre, Magnesia Phosphorica, Rhus Tox, Viscum Album LIQUID ORAL 20160509 UNAPPROVED HOMEOPATHIC The Magni Company ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 6; 4; 6; 6; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 43689-0023_53f66239-1e34-4052-874a-5ed65e0c624e 43689-0023 HUMAN OTC DRUG Pain and Inflammation Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum, Bryonia, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Natrum Sulphuricum GEL TOPICAL 20160602 UNAPPROVED HOMEOPATHIC The Magni Company ARNICA MONTANA; HYPERICUM PERFORATUM; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; SULFURIC ACID; BRYONIA ALBA ROOT; FERRUM PHOSPHORICUM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE 1; 1; 6; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g N 20181231 43689-0024_60e14eac-deda-0f29-e053-2a91aa0a2bdd 43689-0024 HUMAN OTC DRUG Diabetics Dry Skin Relief DIMETHICONE CREAM TOPICAL 20170512 OTC MONOGRAPH FINAL part347 The Magni Group Inc DIMETHICONE 10 mg/g N 20181231 43689-0025_60e19cbe-f178-a045-e053-2a91aa0abbf5 43689-0025 HUMAN OTC DRUG DB Antifungal foot MICONAZOLE NITRATE CREAM TOPICAL 20170427 OTC MONOGRAPH FINAL part333C The Magni Group Inc MICONAZOLE NITRATE 20 mg/g N 20181231 43689-0026_60e1b2fb-645d-badf-e053-2a91aa0a9a55 43689-0026 HUMAN OTC DRUG DB Pain Relieving PSEUDOGNAPHALIUM OBTUSIFOLIUM, APIS MELLIFERA, GELSEMIUM SEMPERVIRENS ROOT CREAM TOPICAL 20170510 UNAPPROVED HOMEOPATHIC The Magni Group Inc PSEUDOGNAPHALIUM OBTUSIFOLIUM; APIS MELLIFERA; GELSEMIUM SEMPERVIRENS ROOT 6; 3; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20191231 43689-0027_60e1b2fb-647e-badf-e053-2a91aa0a9a55 43689-0027 HUMAN OTC DRUG Relaxing Leg Cream Homeopathic PM CAUSTICUM, PSEUDOGNAPHALIUM OBTUSIFOLIUM CREAM TOPICAL 20170524 UNAPPROVED HOMEOPATHIC The Magni Group Inc CAUSTICUM; PSEUDOGNAPHALIUM OBTUSIFOLIUM 8; 6 [hp_X]/113g; [hp_X]/113g N 20181231 43689-0028_60e1b068-4df6-badb-e053-2a91aa0a9739 43689-0028 HUMAN OTC DRUG Relaxing Leg Homeopathic CAUSTICUM, PSEUDOGNAPHALIUM OBTUSIFOLIUM CREAM TOPICAL 20170525 UNAPPROVED HOMEOPATHIC The Magni Group Inc CAUSTICUM; PSEUDOGNAPHALIUM OBTUSIFOLIUM 8; 6 [hp_X]/113g; [hp_X]/113g N 20181231 43689-0029_60e1c8e8-2b13-d8e6-e053-2a91aa0a4cd9 43689-0029 HUMAN OTC DRUG PAIN AND ITCH RELIEF DAPHNE MEZEREUM BARK, GELSEMIUM SEMPERVIRENS ROOT GEL TOPICAL 20170706 UNAPPROVED HOMEOPATHIC Magni Group DAPHNE MEZEREUM BARK; GELSEMIUM SEMPERVIRENS ROOT 6; 6 [hp_X]/51g; [hp_X]/51g N 20191231 43689-0031_5189335b-b380-5b32-e054-00144ff8d46c 43689-0031 HUMAN OTC DRUG Leg and Back Pain Relief ATROPA BELLADONNA,CAPSICUM,CITRULLUS COLOCYNTHIS FRUIT PULP,MAGNESIUM PHOSPHATE, DIBASIC,TOXICODENDRON RADICANS LEAF,HYPERICUM PERFORATUM CREAM TOPICAL 20170608 UNAPPROVED HOMEOPATHIC The Magni Group Inc ATROPA BELLADONNA; CAPSICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC; TOXICODENDRON RADICANS LEAF; HYPERICUM PERFORATUM 3; 3; 3; 3; 3; 3 [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g N 20181231 43689-0032_60e15337-c597-500e-e053-2991aa0abed0 43689-0032 HUMAN OTC DRUG Breathe Easy Chest ARSENIC TRIOXIDE, IPECAC, PHOSPHORUS, POLYGALA SENEGA ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA WHOLE CREAM TOPICAL 20170716 UNAPPROVED HOMEOPATHIC Magni Group ARSENIC TRIOXIDE; IPECAC; PHOSPHORUS; POLYGALA SENEGA ROOT; ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA WHOLE 6; 3; 6; 3; 6; 3 [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g N 20181231 43689-0033_4f1d24de-26de-57e2-e054-00144ff88e88 43689-0033 HUMAN OTC DRUG Pain Relieving Foot APIS MELLIFERA, PSEUDOGNAPHALIUM OBTUSIFOLIUM, GELSEMIUM SEMPERVIRENS ROOT CREAM TOPICAL 20170505 UNAPPROVED HOMEOPATHIC The Magni Group Inc PSEUDOGNAPHALIUM OBTUSIFOLIUM; APIS MELLIFERA; GELSEMIUM SEMPERVIRENS ROOT 6; 3; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43689-0034_60e16a83-20d2-63b8-e053-2a91aa0aaeed 43689-0034 HUMAN OTC DRUG Arnica Pain Relief ARNICA MONTANA GEL TOPICAL 20170620 UNAPPROVED HOMEOPATHIC Magni Group ARNICA MONTANA 3 [hp_X]/113g N 20181231 43695-0001_efc656c5-7f47-43e8-abec-a919b8680ca8 43695-0001 HUMAN OTC DRUG Libido for Her Agnus castus, Berberis vulgaris, Damiana, Graphites, Ignatia amara, Lactuca virosa, Onosmodium virginianum, SPRAY ORAL 20120425 UNAPPROVED HOMEOPATHIC Pacific Naturals CHASTE TREE; BERBERIS VULGARIS ROOT BARK; TURNERA DIFFUSA LEAFY TWIG; GRAPHITE; STRYCHNOS IGNATII SEED; LACTUCA VIROSA; ONOSMODIUM VIRGINIANUM WHOLE 3; 6; 1; 8; 6; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 43695-0002_43423bb3-2646-4d2f-88a7-122662701e27 43695-0002 HUMAN OTC DRUG Smoke Deter ABIES NIGRA, ACONITUM NAPELLUS, ARSENICUM IODATUM, AVENA SATIVA, IGNATIA AMARA, LUNG SUIS, NUX VOMICA, SPRAY ORAL 20141218 UNAPPROVED HOMEOPATHIC Pacific Naturals PICEA MARIANA RESIN; ACONITUM NAPELLUS; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; SUS SCROFA LUNG; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; TOBACCO LEAF 10; 200; 200; 1; 200; 6; 10; 3; 3; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43695-0003_20d1cef0-5ae5-423c-a1ec-436297f6dc64 43695-0003 HUMAN OTC DRUG Venapro Aesculus hippocastanum, Arnica montana, Calcarea fluorica, Carduus marianus, Collinsonia canadensis, Hamamelis virginiana, Muriaticum acidum, Ratanhia, SPRAY ORAL 20140515 UNAPPROVED HOMEOPATHIC Pacific Naturals HORSE CHESTNUT; ARNICA MONTANA; CALCIUM FLUORIDE; MILK THISTLE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT 1; 3; 10; 1; 3; 1; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43695-0004_731a86c4-a67b-4d5a-9b66-96a81fb683cb 43695-0004 HUMAN OTC DRUG Miracet Abies Nigra, Aconitum Napellus, Arsenicum Iodatum, Avena Sativa, Ignatia Amara, Lung Suis, Nux Vomica, Plantago Major, Quebracho LIQUID ORAL 20130801 UNAPPROVED HOMEOPATHIC Pacific Naturals PICEA MARIANA RESIN; ACONITUM NAPELLUS; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; SUS SCROFA LUNG; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; TOBACCO LEAF 10; 200; 200; 1; 200; 6; 10; 3; 3; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43695-0005_f232396b-a4d1-48df-ad3d-354abd263efb 43695-0005 HUMAN OTC DRUG Zeta Clear Antimonium Crudum, Arsenicum Album, Mancinella, Nitricum Acidum, Sulphur, Thuja Occidentalis LIQUID ORAL 20130425 UNAPPROVED HOMEOPATHIC Pacific Naturals ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; NITRIC ACID; SULFUR; THUJA OCCIDENTALIS LEAF 200; 200; 30; 30; 12; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43695-0006_b1e8fe86-41ad-486b-b34e-4f360a4ea9f6 43695-0006 HUMAN OTC DRUG Yeastrol Baptisia Tinctoria, Borax, Candida Albicans, Candida Parapsilosis, Echinacea (Angustifolia), Kreosotum, Mercurius Cyanatus, Mercurius Sulphuratus Ruber, Nitricum Acidum, Pyrogenium, Sulphuricum Acidum, Thuja Occidentalis SPRAY ORAL 20150318 UNAPPROVED HOMEOPATHIC Pacific Naturals BAPTISIA TINCTORIA ROOT; SODIUM BORATE; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA ANGUSTIFOLIA; WOOD CREOSOTE; MERCURIC CYANIDE; MERCURIC SULFIDE; NITRIC ACID; RANCID BEEF; SULFURIC ACID; THUJA OCCIDENTALIS LEAFY TWIG 3; 30; 12; 12; 3; 30; 30; 30; 30; 200; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43695-0007_2d8efb27-8ba9-425c-afe4-59f554a0c778 43695-0007 HUMAN OTC DRUG BoilX Anthracinum, Baptisia Tinctoria, Calcarea Picrata, Echinacea (Angustifolia), Hepar Sulphuris Calcareum, Mercurius Corrosivus, Pyrogenium SPRAY ORAL 20150109 UNAPPROVED HOMEOPATHIC Global Naturals, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; CALCIUM PICRATE; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; MERCURIC CHLORIDE; RANCID BEEF 30; 3; 6; 3; 200; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43695-0008_80ad124f-e871-4324-a6da-846530e90f1a 43695-0008 HUMAN OTC DRUG WARTROL Antimonioum Crudum, Baptisia Tinctoria, Causticum, Nitricum Acidum, Thuja Occidentalis SPRAY ORAL 20150109 UNAPPROVED HOMEOPATHIC Pacific Naturals ANTIMONY TRISULFIDE; BAPTISIA TINCTORIA ROOT; CAUSTICUM; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG 30; 3; 200; 200; 200 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43695-0009_f0c7c0f2-0181-406c-a692-8a9d1c637879 43695-0009 HUMAN OTC DRUG TINNITUS CONTROL NOT APPLICABLE LIQUID ORAL 20141014 UNAPPROVED HOMEOPATHIC Pacific Naturals ARNICA MONTANA; QUININE SULFATE; IRON; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; PULSATILLA VULGARIS; SILICON DIOXIDE; ALLYLTHIOUREA 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43695-0010_22533e1e-86d1-4867-8842-d50533b49152 43695-0010 HUMAN OTC DRUG Oxyhives Apis Mellifica, Arnica Montana, Hepar Suis, Ichthyolum, Lachesis Mutus, Mercurius Solubilis, Rhus Tox, Urtica Urens SPRAY ORAL 20150326 UNAPPROVED HOMEOPATHIC Global Naturals, Inc. APIS MELLIFERA; ARNICA MONTANA; PORK LIVER; ICHTHAMMOL; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 200; 6; 6; 6; 30; 200; 200; 200 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43695-0011_bae5581d-5cea-4761-be1e-22de90cf24ba 43695-0011 HUMAN OTC DRUG Herpeset Apis Mellifica, Arsenicum Album, Baptisia Tinctoria, Capsicum Annuum, Dulcamara, Echinacea, Nitricum Acidum, Pyrogenium, Rhus Tox LIQUID ORAL 20170406 UNAPPROVED HOMEOPATHIC Global Naturals, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CAPSICUM; SOLANUM DULCAMARA TOP; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 3; 200; 3; 6; 30; 3; 200; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43734-001_ce700d92-fe47-49e0-8919-873d9cc75eee 43734-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20120501 NDA NDA205849 Childrens Hospital of Philadelphia OXYGEN 99 L/100L E 20171231 43734-002_a42cc432-db96-416b-a0e1-2b9f4b0d0f0f 43734-002 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20120501 NDA NDA205849 Childrens Hospital of Philadelphia OXYGEN 99 L/100L E 20171231 43742-0001_39c22b27-2f78-4d0e-9394-36543c6c4a31 43742-0001 HUMAN OTC DRUG Rheumatism Benzoicum acidum, Pulsatilla, Rhododendron chrysanthum, Spiraea ulmaria, Aconitum napellus, Dulcamara, Euphorbium officinarum, Ledum palustre, Asclepias tuberosa, Lithium benzoicum, LIQUID ORAL 20120405 20200925 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BENZOIC ACID; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; FILIPENDULA ULMARIA ROOT; ACONITUM NAPELLUS; SOLANUM DULCAMARA FLOWER; EUPHORBIA RESINIFERA RESIN; LEDUM PALUSTRE TWIG; ASCLEPIAS TUBEROSA ROOT; LITHIUM BENZOATE 3; 3; 3; 3; 4; 4; 4; 4; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0002_93485ff1-f616-4703-b832-2eab290521ea 43742-0002 HUMAN OTC DRUG Biological Complex I Variolinum LIQUID ORAL 20140621 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 30 [hp_C]/mL N 20181231 43742-0003_6be88fe4-ef01-44c8-b655-947a46a3b5ed 43742-0003 HUMAN OTC DRUG Biological Complex II Anthracinum, LIQUID ORAL 20120416 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 30 [hp_C]/mL N 20181231 43742-0004_dd82ab4a-6fa2-41b1-9a1e-06c24df1197d 43742-0004 HUMAN OTC DRUG Heart Small Intestine Meridian Formula Adrenlinum, Coumarinum, Tyramine, Arteria Suis, Ascorbic Acid, Cactus Grandiflorus, Coenzyme A, Glonoinum, Heart (Suis), Sarcolacticum Acidum, Ubidecarenonum, Vein (Suis), Adrenocorticotrophin, Arsenicum Album, Aurum Metallicum, Belladonna, Digitalis Purpurea, Kali Carbonicum, Lithium Carbonicum, Lycopodium Clavatum, Mercurius Solubilis, Naja Tripudians, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris), Spigelia Anthelmia, Dysentery Bacillus, Gaertner Bacillus LIQUID ORAL 20120413 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EPINEPHRINE; COUMARIN; TYRAMINE; SUS SCROFA ARTERY; ASCORBIC ACID; SELENICEREUS GRANDIFLORUS STEM; UBIDECARENONE; COENZYME A; PORK HEART; NITROGLYCERIN; LACTIC ACID, L-; SUS SCROFA VEIN; CORTICOTROPIN; ARSENIC TRIOXIDE; GOLD; ATROPA BELLADONNA; DIGITALIS; POTASSIUM CARBONATE; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SPIGELIA ANTHELMIA; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0005_b3530e74-e556-4fa3-a6d6-e16f9efdbfa5 43742-0005 HUMAN OTC DRUG B Complex Mix Magnesium oroticum, Beta vulgaris, Ascorbicum acidum, Citricum acidum, Cysteinum, Pulsatilla, Adenine, Amygdalin, ATP, Cholinum, Cyanocopalamin, Folic Acid, Insotil, Niacin, p-aminobenzoic acid, Pangamic acid, Panthothenic acid, LIQUID ORAL 20120416 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MAGNESIUM OROTATE; BETA VULGARIS; ASCORBIC ACID; ANHYDROUS CITRIC ACID; CYSTEINE; PULSATILLA VULGARIS; ADENINE; AMYGDALIN; ADENOSINE TRIPHOSPHATE; CHOLINE HYDROXIDE; CYANOCOBALAMIN; FOLIC ACID; INOSITOL; NIACIN; AMINOBENZOIC ACID; PANGAMIC ACID; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SULFUR; THIAMINE; SODIUM DIETHYL OXALACETATE; OROTIC ACID MONOHYDRATE; MANGANESE PHOSPHATE, DIBASIC; ESCHERICHIA COLI; PROTEUS MORGANII 12; 2; 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 8; 10; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0006_4c417ec3-3a95-4dda-91e7-d8cf2a58bff9 43742-0006 HUMAN OTC DRUG Insect Bite Hypericum Perforatum, Ledum Palustre, Latrodectus Mactans, Loxosceles Reclusa, Tarentula Cubensis, Tarentula Hispana, Lachesis Mutus, Lycopus Virginicus, Theridion, Cimex Lectularius, Formica Rufa, Pulex Irritans, Vespa Crabro LIQUID ORAL 20110926 20200915 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LATRODECTUS MACTANS; CITHARACANTHUS SPINICRUS; LYCOSA TARANTULA; LACHESIS MUTA VENOM; LYCOPUS VIRGINICUS; THERIDION CURASSAVICUM; CIMEX LECTULARIUS; FORMICA RUFA; PULEX IRRITANS; VESPA CRABRO; LOXOSCELES RECLUSA 3; 4; 8; 8; 8; 10; 12; 12; 15; 15; 15; 15; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0008_03c1d09f-3fe7-4215-b63e-d141b5755c17 43742-0008 HUMAN OTC DRUG Heart Fatigue Spigelia Anthelmia, Kali Carbonicum, Arnica Montana, Cactus Grandiflorus, Gelsemium Sempervirens, Castoreum, Glonoinum, Ranunculus Bulbosus, Heart (Suis), Abrotanum, Sulphur LIQUID ORAL 20120418 20210422 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SPIGELIA ANTHELMIA; POTASSIUM CARBONATE; ARNICA MONTANA; SELENICEREUS GRANDIFLORUS STEM; GELSEMIUM SEMPERVIRENS ROOT; CASTOR CANADENSIS SCENT GLAND SECRETION; NITROGLYCERIN; RANUNCULUS BULBOSUS; PORK HEART; ARTEMISIA ABROTANUM FLOWERING TOP; SULFUR 2; 3; 4; 4; 4; 6; 6; 6; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0009_aefff66a-3453-43eb-8ed9-cadabb908145 43742-0009 HUMAN OTC DRUG Geopathic Stress Alfalfa, Laminaria digitata, Symphytum officinale, Calcarea carbonica, Ferrum metallicum, Agate, Iodium, Magnesium metallicum, Manganum metallicum, Quartz, Tarentula cubensis, Cuprum metallicum, Phosphorus, X-ray, Carbon dioxide, Silicea Magnetis polus articus, Magnetis polus australis, LIQUID ORAL 20120419 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALFALFA; LAMINARIA DIGITATA; COMFREY ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IRON; SILICON DIOXIDE; IODINE; MAGNESIUM; MANGANESE; CITHARACANTHUS SPINICRUS; COPPER; PHOSPHORUS; ALCOHOL, X-RAY EXPOSED (1000 RAD); CARBON DIOXIDE 3; 3; 3; 8; 8; 12; 12; 12; 12; 15; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0010_e05f9921-4b29-4abd-b3a2-c17697d549bc 43742-0010 HUMAN OTC DRUG Brain Blance Core Formula Acetylcholine chloride, Dopamine, GABA, Octopamine, Serotonin, Taurine, Adenosinum cyclophosphoricum, Cerebrum (suis), Diencephalon (suis), Pineal gland (suis), Thalamus opticus (suis), LIQUID ORAL 20120507 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc ACETYLCHOLINE CHLORIDE; DOPAMINE; .GAMMA.-AMINOBUTYRIC ACID; OCTOPAMINE; SEROTONIN; TAURINE; ADENOSINE CYCLIC 3',5'-PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0011_e2109328-fa18-42d9-9f39-fe0679cde632 43742-0011 HUMAN OTC DRUG Lymph Spleen Combo Castanea vesca, Juniperus communis, Phytolacca decandra, Quercus glandium spiritus, Myosotis arvensis, Natrum sulphuricum, Ceanothus americanus, Helianthus annuus, Natrum muriaticum, Lymph (suis), Spleen (suis), Thymus (suis), LIQUID ORAL 20120501 20180806 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CASTANEA SATIVA LEAF; JUNIPER BERRY; PHYTOLACCA AMERICANA ROOT; QUERCUS ROBUR NUT; MYOSOTIS ARVENSIS; SODIUM SULFATE; CEANOTHUS AMERICANUS LEAF; HELIANTHUS ANNUUS FLOWERING TOP; SODIUM CHLORIDE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; QUININE ARSENATE; ADENOSINE TRIPHOSPHATE; UBIDECARENONE; IRON; AMBER; APIS MELLIFERA 3; 3; 3; 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0012_daef8988-e058-4734-9265-8a54631a67b1 43742-0012 HUMAN OTC DRUG Multiple Miasm Arsenicum Album, Lycopodium Clavatum, Sulphur, Aloe, Carcinosin, Nitricum Acidum, Silicea, Thuja Occidentalis LIQUID ORAL 20130910 20201209 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; SULFUR; ALOE; HUMAN BREAST TUMOR CELL; NITRIC ACID; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0013_2d1d57c0-7710-4967-a36b-adcabe18e46c 43742-0013 HUMAN OTC DRUG Celeragesic Cchinacea, Echinacea purpurea, Hamamelis virginiana, Bellis perennis, Calendula officinalis, Aconitum napellus, Chamomilla, Hypericum perforatum, Belladonna, Millefolium, Bryonia, Rhus toxicodendron, ATP, Coenzyme A, LIQUID ORAL 20120430 20180702 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ACONITUM NAPELLUS; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; ATROPA BELLADONNA; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; ADENOSINE TRIPHOSPHATE; COENZYME A; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; NADIDE; ORNITHOGALUM UMBELLATUM; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; LACTIC ACID, L-; COMFREY ROOT; ACTIVATED CHARCOAL; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; SUS SCROFA THALAMUS; PROTEUS MORGANII; UBIDECARENONE 2; 2; 2; 2; 2; 3; 3; 3; 3; 3; 4; 4; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 30; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 43742-0014_ec909850-500c-4a80-88f7-0166f18b91a4 43742-0014 HUMAN OTC DRUG Appetite Control Thyroidinum (Suis), Cortisone Aceticum, Anacardium Orientale, Antimonium Crudum, Ignatia Amara, Natrum Muriaticum, Staphysagria, Cortisol LIQUID ORAL 20120427 20190107 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc THYROID, PORCINE; CORTISONE ACETATE; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; DELPHINIUM STAPHISAGRIA SEED; HYDROCORTISONE 12; 12; 15; 15; 15; 15; 18; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0015_98afc8b4-115c-48a7-8b80-74ab4dd6e00e 43742-0015 HUMAN OTC DRUG Biological Complex III Anthracinum, Arsenicum album, Botulinum, Calcarea hypophosphorosa, Coxiella burnetii, Dysentery bacillus, Francisella tularensis, Gaertner bacillus, Kali sulphuricum, Lac caninum, Malaria officinalis, Mutabile bacillus, Pertussinum, Pestinum, Pyrogenium, Typhoid fever, LIQUID ORAL 20120426 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARSENIC TRIOXIDE; BOTULINUM TOXIN TYPE A; CALCIUM HYPOPHOSPHITE; COXIELLA BURNETII; SHIGELLA DYSENTERIAE; FRANCISELLA TULARENSIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; POTASSIUM SULFATE; CANIS LUPUS FAMILIARIS MILK; PLASMODIUM MALARIAE; ESCHERICHIA COLI; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; YERSINIA PESTIS; RANCID BEEF; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0016_491f6eff-6f00-4948-aeb9-2ab4c66d1324 43742-0016 HUMAN OTC DRUG Nerve Z Condurango, Echinacea, Ginkgo Biloba, Hydrastis Canadensis, Myrrha, OSHA, Phytolacca Decandra, Tabebuia Impetiginosa, Propolis, Glandula Suprarenalis Suis, Spleen (Suis), Thymus (Suis), Thyroidinum (Suis), Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Selenium Metallicum, Pyrogenium LIQUID ORAL 20120502 20190106 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MARSDENIA CONDURANGO BARK; ECHINACEA, UNSPECIFIED; GINKGO; GOLDENSEAL; MYRRH; LIGUSTICUM PORTERI ROOT; PHYTOLACCA AMERICANA ROOT; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; THYROID, PORCINE; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SELENIUM; RANCID BEEF 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0017_8c0fcd4b-5c04-4be3-bfb0-859f79fef9f7 43742-0017 HUMAN OTC DRUG Amoeba Baptisia Tinctoria, Cajuputum, Capsicum Annuum, Fragaria Vesca, Frasera, Hamamelis Virginiana, Hydrastis Canadensis, Quassia Amara, Senna, Ipecacuanha, Hepar Suis, Pancreas Suis, Spleen (Suis), Belladonna, Cinchona Officinalis, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Selenium Metallicum Amoeba Axis, Blastocystis Hominis, Cryptosporidium Parvum, Giardia Lamblia LIQUID ORAL 20120508 20181029 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BAPTISIA TINCTORIA ROOT; CAJUPUT OIL; CAPSICUM; ALPINE STRAWBERRY; FRASERA CAROLINIENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; GOLDENSEAL; QUASSIA AMARA WOOD; SENNA LEAF; IPECAC; PORK LIVER; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; SELENIUM; AMOEBA PROTEUS; BLASTOCYSTIS HOMINIS; CRYPTOSPORIDIUM PARVUM; GIARDIA LAMBLIA 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0018_5c4f8d19-b007-46e5-87f3-1acc9f7526b3 43742-0018 HUMAN OTC DRUG Candida Plus Echinacea, Hydrastis canadensis, Phytolacca decandra, Alternaria tenuis, Aspergillus niger, Geotrichum candidum, Mucor racemosus, Pullularia pullulans, Rhizopus nigra, Acetaldehyde, Caffeic acid, Gallicum acidum, LIQUID ORAL 20120425 20190213 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA, UNSPECIFIED; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; GEOTRICHUM CANDIDUM; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; ACETALDEHYDE; CAFFEIC ACID; GALLIC ACID MONOHYDRATE; INDOLE; YEAST MANNAN; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SACCHAROMYCES CEREVISIAE; CANDIDA ALBICANS; RHIZOPUS STOLONIFER 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0019_0b7738a7-9977-4b7f-9943-af72fc9057fc 43742-0019 HUMAN OTC DRUG Allergy Rescue Acetylcholine chloride, Histaminum hydrochloricum, Serotonin, LIQUID ORAL 20120426 20180219 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; HISTAMINE DIHYDROCHLORIDE; SEROTONIN 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0020_1089da4f-6280-4b75-8e03-3fa84efd05b5 43742-0020 HUMAN OTC DRUG Adrenal Support Aralia quinquefolia, Humulus lupulus, Adrenalinum, Cortisone aceticum, Thyroidinum (suis), Selenium metallicum, Arsenicum album, Calcarea carbonica, Convallaria majalis, Crotalus horridus, Ferrum metallicum, Nux vomica, Phosphorus, Sepia, Phosphoricum acidum, LIQUID ORAL 20120502 20201215 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMERICAN GINSENG; HOPS; EPINEPHRINE; CORTISONE ACETATE; THYROID, PORCINE; SELENIUM; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; IRON; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE; PHOSPHORIC ACID 3; 3; 6; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0021_de1c6649-15b9-42bc-a4fb-a38e90f9dc9e 43742-0021 HUMAN OTC DRUG Testosterone Testosterone, LIQUID ORAL 20120426 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TESTOSTERONE 6 [hp_X]/mL N 20181231 43742-0022_ce6b6a7c-dcd0-4bf5-a20d-998d66098fc4 43742-0022 HUMAN OTC DRUG HGH Vitality Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-Dopa, Melatonin, Testosterone, Adenosinum Triphosphoricum Dinatrum, Alpha-Lipocicum Acidum, Coenzyme A, Co-Enzyme Q-10, Nadidum, Sarcolacticum Acidum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (Suis), Lymph (Suis), Medulla Ossis Suis, Oophorinum (Suis), Orichitinum (Suis), Pancreas Suis, Spleen (Suis), Human Growth Hormone, Morgan Bacillus TABLET ORAL 20120920 20200126 UNAPPROVED HOMEOPATHIC Deseret Biologicals CHASTE TREE; AMBERGRIS; CONIUM MACULATUM FLOWERING TOP; APIOLE (PARSLEY); ESTRADIOL; ESTRIOL; ESTRONE; LEVODOPA; MELATONIN; TESTOSTERONE; .ALPHA.-LIPOIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; COENZYME A; UBIDECARENONE; NADIDE; LACTIC ACID, L-; BARIUM CARBONATE; SELENIUM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SOMATROPIN; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 N 20181231 43742-0023_198269f2-95c8-4ac9-a1c7-d5ad4e5c2d54 43742-0023 HUMAN OTC DRUG Upper Respiratory Staph Strep Combination Staphlyococcus Aureus, Klebsiella Pneumoniae, Haemophilus Infulenzae B, Streptococcus Agalactiae, Streptococcus Alpha, TABLET ORAL 20120831 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. STAPHYLOCOCCUS AUREUS; KLEBSIELLA PNEUMONIAE; HAEMOPHILUS INFLUENZAE TYPE B; STREPTOCOCCUS AGALACTIAE; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE 15; 15; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 43742-0024_e4ca8d29-0a81-4426-bc5c-56708d24c711 43742-0024 HUMAN OTC DRUG Professional Weight Support Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Hepar Suis, Methylcobalamin, Renal (Suis), Gambogia, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto Dehydroepiandrosterone, Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulin, Sarcolacticum Acidum, Proteus Bach TABLET ORAL 20120918 UNAPPROVED HOMEOPATHIC Deseret Biologicals CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK LIVER; METHYLCOBALAMIN; PORK KIDNEY; GAMBOGE; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 N 20181231 43742-0025_7a1f20e4-1b4f-4ffc-b63f-b678bf6e46f3 43742-0025 HUMAN PRESCRIPTION DRUG Perfect Sleep Adenosine Triphosphate (ATP), Coenzyme A, Coenzyme Q10, Pineal Gland (suis), Sarcolacticum Acidum, Melatonin TABLET ORAL 20120829 UNAPPROVED HOMEOPATHIC Deseret Biologicals ADENOSINE TRIPHOSPHATE; COENZYME A; UBIDECARENONE; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; MELATONIN; PYRROLE; TRYPTOPHAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE; ZINC VALERATE DIHYDRATE; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1 Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 43742-0026_6300af6c-0aa4-41c8-ac60-11e0f51cf57f 43742-0026 HUMAN PRESCRIPTION DRUG Energise RxS Sarcolacticum Acidum, Viscum Album, Iodium, Colchicum Atumnale, Conium Maculatum, Fucus Vesiculosus, Galiu Aparine, Natrum Oxalaceticum TABLET ORAL 20120926 UNAPPROVED HOMEOPATHIC Deseret Biologicals LACTIC ACID, L-; VISCUM ALBUM FRUITING TOP; IODINE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; FUCUS VESICULOSUS; GALIUM APARINE; SODIUM DIETHYL OXALACETATE; THYROID, PORCINE; PRASTERONE; PHENYL ISOTHIOCYANATE; LIOTHYRONINE; TYRAMINE; .ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE; FUMARIC ACID; MALIC ACID; SUS SCROFA UMBILICAL CORD; PORK LIVER; SUS SCROFA BONE MARROW; SUS SCROFA PINEAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; CALCIUM FLUORIDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; CORTISONE ACETATE; MERCURIC CHLORIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; ESCHERICHIA COLI 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 8; 8; 12; 12; 12; 30; 60; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43742-0027_8cef2a1d-aa89-490a-aef6-c817d762a4bb 43742-0027 HUMAN OTC DRUG L Dopa L-Dopa LIQUID ORAL 20120509 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LEVODOPA 6 [hp_X]/mL N 20181231 43742-0028_03ba521c-75fb-4ca3-81de-67ef0bac163b 43742-0028 HUMAN OTC DRUG Tryptophan Tryptophan LIQUID ORAL 20120509 20201110 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TRYPTOPHAN 6 [hp_X]/mL N 20181231 43742-0030_2dac9db6-13af-474f-9eed-6d141141cda6 43742-0030 HUMAN OTC DRUG Matrix Support Ceanothus Americanus, Hydrastis Canadensis, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Momordica Balsamina, Oxalis Acetosella, Pulsatilla, Bile Duct (Suis), Colon (Suis), Duodenum (Suis), Esophagus (Suis), Eye (Suis), Gallbladder (Suis), Ileum (Suis), Intestine (Suis), Ipecacuanha, Jejunum (Suis), Kali Bichromicum, Lung (Suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (Suis), Pancreas Suis, Phosphorus, Rectum (Suis), Stomach (Suis), Sulphur, Mannan LIQUID ORAL 20120514 20200915 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PULSATILLA VULGARIS; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTUM; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; ATROPA BELLADONNA; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 4; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0031_330dddc0-09e9-4bc3-92d5-7b762c9e331c 43742-0031 HUMAN OTC DRUG Systemic Drainage Alfalfa, Avena sativa, Citrus limonum, Glycyrrhiza glabra, Uva-ursi, Taraxacum officinale, Galium aparine, Lobelia inflata, Schisandra chinensis, Solidago virgaurea, Tylophora asthmatica, Berberis vulgaris, Chelidonium majus, Hepar suis, Intestine (suis), Kidney (suis), Lung (suis), Lymph (suis), Magnesium gluconate, Nux vomica, Potassium gluconate, Zincum gluconicum, Sarcolacticum acidum, Lacticum acidum LIQUID ORAL 20120510 20200218 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; LEMON JUICE; GLYCYRRHIZA GLABRA; ARCTOSTAPHYLOS UVA-URSI LEAF; TARAXACUM OFFICINALE; GALIUM APARINE; LOBELIA INFLATA; SCHISANDRA CHINENSIS FRUIT; SOLIDAGO VIRGAUREA FLOWERING TOP; TYLOPHORA INDICA WHOLE; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; PORK LIVER; PORK INTESTINE; PORK KIDNEY; SUS SCROFA LUNG; SUS SCROFA LYMPH; MAGNESIUM GLUCONATE; STRYCHNOS NUX-VOMICA SEED; POTASSIUM GLUCONATE; ZINC GLUCONATE; LACTIC ACID, L-; LACTIC ACID, DL- 1; 1; 1; 1; 1; 2; 3; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0032_e34023ca-a6dd-45e8-8865-03f22106e359 43742-0032 HUMAN OTC DRUG Heart Small Intestine Meridian Opener Arsenicum Album, Aurum Metallicum, Belladonna, Cactus Grandiflorus, Cinchona Officinalis, Digitalis Purpurea, Kali Carbonicum, Lithium Carbonicum, Lycopodium Clavatum, Mercurius Solubilis, Naja Tripudians, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris), Pyrogenium, Spigelia Anthelmia LIQUID ORAL 20120515 20200827 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; GOLD; ATROPA BELLADONNA; SELENICEREUS GRANDIFLORUS STEM; CINCHONA OFFICINALIS BARK; DIGITALIS; POTASSIUM CARBONATE; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; SPIGELIA ANTHELMIA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 43742-0033_80c7d6b9-904a-4b63-a7ad-623a2f2cd7d7 43742-0033 HUMAN OTC DRUG Candida Candida albicans, LIQUID ORAL 20120516 20210113 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CANDIDA ALBICANS 1 [hp_M]/mL N 20181231 43742-0034_e1e49cfc-61c9-460a-a0fc-e53030440ef9 43742-0034 HUMAN OTC DRUG Sinusitis Plus Kali Muriaticum, Calcarea Sulphurica, Sulphur, Mucor Racemosus, Hydrastis Canadensis, Kali Bichromicum, Lachesis Mutus, Mercurius Sulphuratus Ruber, Hepar Sulphuris Calcareum, Argentum Nitricum, Cobaltum Metallicum, Cuprum Metallicum, Manganum Metallicum, Silicea, Aspergillus Fumigatus, Aspergillus Niger, Candida Albicans, Thuja Occidentalis, Sinusitisinum LIQUID ORAL 20120516 20180729 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. POTASSIUM CHLORIDE; CALCIUM SULFATE ANHYDROUS; SULFUR; MUCOR RACEMOSUS; GOLDENSEAL; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MERCURIC SULFIDE; CALCIUM SULFIDE; SILVER NITRATE; COBALT; COPPER; MANGANESE; SILICON DIOXIDE; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; THUJA OCCIDENTALIS LEAFY TWIG; SINUSITISINUM 6; 10; 6; 6; 7; 7; 7; 7; 7; 10; 10; 10; 10; 10; 10; 10; 10; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0035_f8fe5a3c-fe29-4c0b-8421-74724e6664d3 43742-0035 HUMAN OTC DRUG Perfect Sleep Adenosine Triphosphate(ATP), Coenzyme A, Coenzyme Q10, Pineal gland (suis), Sarcolacticum acidum, Melatonin, Pyrrole, Tryptophan, Arsenicum album, Avena sativa, Chamomilla, Coffea cruda, Mercurius corrosivus, LIQUID ORAL 20120601 20180918 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE; COENZYME A; UBIDECARENONE; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; MELATONIN; PYRROLE; TRYPTOPHAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE; ZINC VALERATE DIHYDRATE; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0036_b3a2025e-3655-496f-9ef8-8451b40ef750 43742-0036 HUMAN OTC DRUG H. Pylori Remedy Helicobacter pylori, LIQUID ORAL 20120517 20210315 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HELICOBACTER PYLORI 15 [hp_X]/mL N 20181231 43742-0037_86318293-b536-4feb-8a9b-0edcc6d5a359 43742-0037 HUMAN OTC DRUG FNG Berberis Vulgaris, Cochlearia Armoracia, Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Tabebuia Impetiginosa, Propolis, Glandula Suprarenalis Suis, Thymus (Suis), Ferrum Metallicum, Iridium Metallicum Lycopodium Clavatum, Phosphoricum Acidum, Pulsatilla, Selenium Metallicum, Zincum Metallicum, Stachybotrys Chartarum, Alternaria Tenuis, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Pullularia Pullulans Rhizopus Nigricans, Torula Cerevisiae LIQUID ORAL 20120515 20181010 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; HORSERADISH; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; IRON; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; ANEMONE PULSATILLA WHOLE; SELENIUM; ZINC; STACHYBOTRYS CHARTARUM; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0038_4bdc211c-fdc9-4cff-a525-abd83a6d70d2 43742-0038 HUMAN OTC DRUG LYM Arnica montana, Calendula officinalis, Echinacea, Hydrastis canadensis, Myrrha, Phytolacca Decandra, Tarasacum officinale, Trifolium pratense, Trigonella foenum-graecum, Urtica cioica, Propolis, Adrenalinum, Gunpowder, Thymus (suis), Thyroidinum (suis), Arsenicum album, Cocculus indicus, Iridium metallicum, Lycopodium clavatum Phosphorus, LIQUID ORAL 20120517 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; MYRRH; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; FENUGREEK SEED; URTICA DIOICA; PROPOLIS WAX; EPINEPHRINE; SUS SCROFA THYMUS; THYROID, PORCINE; ARSENIC TRIOXIDE; ANAMIRTA COCCULUS SEED; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; BORRELIA BURGDORFERI; JAPANESE ENCEPHALITIS VIRUS; LEDUM PALUSTRE TWIG; NEISSERIA MENINGITIDIS; HEPATITIS B VIRUS; ACTIVATED CHARCOAL; SULFUR; POTASSIUM NITRATE 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 15; 15; 30; 30; 33; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0039_9df1e6f3-f539-475e-a460-f5df14380aa7 43742-0039 HUMAN OTC DRUG Neuro I Hydrastis canadensis, Taraxacum officinale, Dopamine, L-dopa, Melatonin, Serotonin, LIQUID ORAL 20120516 20180319 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GOLDENSEAL; TARAXACUM OFFICINALE; DOPAMINE; LEVODOPA; MELATONIN; SEROTONIN 3; 3; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0050_130d82b9-f66d-49f6-a542-c336344249ca 43742-0050 HUMAN OTC DRUG Circulation Cactus Grandiflorus, Kali Carbonicum, Kalmia Latifolia, Arnica Montana, Glonoinum, Ignatia Amara, Lacticum Acidum, Ranunculus Bulbosus, Alpha-Ketoglutaricum Acidum, Arsenicum Album, Cor (Suis), Fumaricum Acidum, Hepar Suis, Malic Acid, Natrum Oxalaceticum, Phosphorus, Strophanthus Hispidus, Spigelia Anthelmia, Carbo Vegetabilis, Naja Tripudians, Cytomegalovirus, Epstein-Barr Virus LIQUID ORAL 20120601 20200918 UNAPPROVED HOMEOPATHIC Deseret Biologicals SELENICEREUS GRANDIFLORUS STEM; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; ARNICA MONTANA; NITROGLYCERIN; STRYCHNOS IGNATII SEED; LACTIC ACID, DL-; RANUNCULUS BULBOSUS; .ALPHA.-KETOGLUTARIC ACID; ARSENIC TRIOXIDE; PORK HEART; FUMARIC ACID; PORK LIVER; MALIC ACID; SODIUM DIETHYL OXALACETATE; PHOSPHORUS; STROPHANTHUS HISPIDUS SEED; SPIGELIA ANTHELMIA; ACTIVATED CHARCOAL; NAJA NAJA VENOM; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4 3; 4; 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 12; 15; 17; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0052_92334e1d-cfdf-4c87-bb58-f1f80213cedf 43742-0052 HUMAN OTC DRUG Inflammation II Asafoetida, Kalmia latifolia, Causticum, Colchicum autumnale, Ferrum metallicum, Gnaphalium polycephalum, Lithium benzoicum, Mercurius praecipitatus ruber, Rhus toxicodendron, Spiraea ulmaria, LIQUID ORAL 20120604 20201106 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASAFETIDA; KALMIA LATIFOLIA LEAF; CAUSTICUM; COLCHICUM AUTUMNALE BULB; IRON; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LITHIUM BENZOATE; MERCURIC OXIDE; TOXICODENDRON PUBESCENS LEAF; FILIPENDULA ULMARIA ROOT 8; 8; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0053_ba664a65-b235-48b7-97fe-0e779da386fd 43742-0053 HUMAN OTC DRUG Spine and Nerve Balance Core Formula Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Cuprum Aceticum, Nadidum, Natrum Oxalaceticum, Nicotinamidum, Picricum Acidum Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Alpha-Lipoicum Acidum, Ammonium Muriaticum, Cartilago Suis, Discus Intervertebralis (Suis), Silicea, Argentum Metallicum, Calcarea Phosphorica, Coenzyme A, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis LIQUID ORAL 20140306 20200930 UNAPPROVED HOMEOPATHIC Deseret Biologicals Inc. BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; CUPRIC ACETATE; NADIDE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PICRIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; .ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; COENZYME A; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SUS SCROFA BONE MARROW; MERCURIC OXIDE; SULFUR; ENTEROBACTER CLOACAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII; PROTEUS VULGARIS 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 28; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0054_df1aa589-26db-45e2-bcd9-e20fb0f761ca 43742-0054 HUMAN OTC DRUG Stomach Spleen Meridian Formula Cortisol, Histaminum Hydrochloricum, Adenosine Triphosphate, Ascorbicum Acidum, Pyridoxinum Hydrochloricum, Riboflavinum, Sarcolacticum Acidum, Spleen (Suis), Stomach (Suis), Cortisone Aceticum, Arsenicum Album, Calcarea Carbonica, Carduus Marianus, Ceanothus Americanus, Cinchona Officinalis, Digitalis Purpurea, Dysentery Bacillus, Ignatia Amara, Kale Bichromicum, Lycopodium Clavatum, Phosphorus, Plumbum Metallicum, Pulsatilla (Vulgaris) Ranunculus Bulbosus, Veratrum Viride LIQUID ORAL 20120713 20180924 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HYDROCORTISONE; HISTAMINE DIHYDROCHLORIDE; ADENOSINE TRIPHOSPHATE; ASCORBIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; LACTIC ACID, L-; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; CORTISONE ACETATE; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILYBUM MARIANUM SEED; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; DIGITALIS; SHIGELLA DYSENTERIAE; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; LEAD; ANEMONE PULSATILLA WHOLE; RANUNCULUS BULBOSUS; VERATRUM VIRIDE ROOT 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0055_df12cfb6-1a66-4393-84fa-fe69df1fa8c5 43742-0055 HUMAN OTC DRUG Polarity Plus Aqua solis, Argentum metallicum, Aurum metallicim, Cuprum metallicum, Lapis albus, Manganum metallicum, Vanadium metallicum, Viscum album, Zincum metallicum LIQUID ORAL 20120607 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. WATER; SILVER; GOLD; COPPER; CALCIUM HEXAFLUOROSILICATE; MANGANESE; VANADIUM; VISCUM ALBUM FRUITING TOP; ZINC 30; 1; 1; 1; 1; 1; 1; 1; 1 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 43742-0056_cdbdf510-798a-48fd-984c-3723cd595d17 43742-0056 HUMAN OTC DRUG Post-Dental Visit Chamomilla, Echinacea, Hamamelis virginiana, Hypericum perforatum, Millefolium, Bryonia, Calendula officinalis, Arnica montana, Belladonna, Bellis perennis, Rhus toxicodendron, Hepar sulphuris calcareum, Star of Bethleham, Rock Rose, Impatiens, Cherry plum, Clematis, Carbo vegetabilis LIQUID ORAL 20120618 20190114 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; TOXICODENDRON PUBESCENS LEAF; CALCIUM SULFIDE; ORNITHOGALUM UMBELLATUM; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; ACTIVATED CHARCOAL 3; 3; 3; 3; 3; 4; 4; 4; 6; 6; 6; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0057_402c89fd-89a9-4f50-8cd2-8087c5b9ca38 43742-0057 HUMAN OTC DRUG Stress EZ Aralia Quinquefolia, Ginkgo Biloba, Hydrocotyle Asiatica, Lomatium Dissectum, Cobaltum Metallicum, Cuprum Metallicum, Gelsemium Sempervirens, Iodium, Vanadium Metallicum, Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos LIQUID ORAL 20120605 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMERICAN GINSENG; GINKGO; CENTELLA ASIATICA; LOMATIUM DISSECTUM ROOT; COBALT; COPPER; GELSEMIUM SEMPERVIRENS ROOT; IODINE; VANADIUM; ORNITHOGALUM UMBELLATUM; HELIANTHEMUM NUMMULARIUM FLOWER; PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER 3; 3; 3; 3; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0058_6d9b0abd-75df-418c-a282-0767c11b8815 43742-0058 HUMAN OTC DRUG Taurine Taurine, LIQUID ORAL 20120604 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TAURINE 6 [hp_X]/mL N 20181231 43742-0059_889c21d2-3eff-4ffb-a94a-9fa11521e0b0 43742-0059 HUMAN OTC DRUG Serotonin Serotonin, LIQUID ORAL 20120604 20180212 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SEROTONIN 6 [hp_X]/mL N 20181231 43742-0060_403fe2f5-6a5c-4682-9704-1f48f5a36fb1 43742-0060 HUMAN OTC DRUG Thyroplus Fucus Vesiculosus, Spongia Tosta, Phosphoricum Acidum, Pituitary (Suis), Thyroidinum (Suis), Calcarea Carbonica, Iodium, Iridium Metallicum LIQUID ORAL 20120626 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; IRIDIUM 3; 4; 6; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0061_f492229b-78a5-4f3a-a487-2d2e1c55efdd 43742-0061 HUMAN OTC DRUG Detox I Carduus marianus, Chelidonium majus, Cinchona officinalis, Lycopodium clavatum, Taraxacum officinale, Veratrum album, Avena sativa, Cynara scolymus, Methylcobalamin, Menadione, Alpha-Lipoicum Acidum, Hepar suis, Colon (Suis), Duodenum (Suis), Gallbladder (Suis), Intestine (Suis), Lymph Node (Suis), Pancreas Suis, Thymus (Suis), Alpha-Ketoglutaricum Acidum, Cholesterinum, Formicum Acidum, Glyoxal Trimer Dihydrate, Histaminum Hydrochloricum, Malic Acid, Natrum Oxalaceticum, Sulphur LIQUID ORAL 20120629 20200925 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT; AVENA SATIVA FLOWERING TOP; CYNARA SCOLYMUS LEAF; METHYLCOBALAMIN; MENADIONE; .ALPHA.-LIPOIC ACID; PORK LIVER; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; PORK INTESTINE; SUS SCROFA LYMPH; SUS SCROFA PANCREAS; SUS SCROFA THYMUS; .ALPHA.-KETOGLUTARIC ACID; CHOLESTEROL; FORMIC ACID; GLYOXAL TRIMER DIHYDRATE; HISTAMINE DIHYDROCHLORIDE; MALIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; OROTIC ACID MONOHYDRATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII 3; 4; 4; 4; 4; 4; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 13; 28; 7; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0063_a34bdbb4-ece2-4911-89ea-95e6bdc982a4 43742-0063 HUMAN OTC DRUG Coumarin Coumarinum, LIQUID ORAL 20120627 20181219 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COUMARIN 6 [hp_X]/mL N 20181231 43742-0064_342658d2-9373-4bb7-9d93-edfb0f490d82 43742-0064 HUMAN OTC DRUG Chemtox Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Glandula Suprarenalis Suis, Hepar Suis, Lymph Node (Suis), Thyroidinum (Suis), Belladonna, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum, Selenium Metallicum, Salicylicum Acidum, Adrenocorticotrophin, Cortisone Aceticum, Eugenol, Stearyl Alcohol, Xylitol, Folliculinum, Benzoicum Acidum, Chlorinum, Potassium Sorbate, Sorbitol, Resorcinum LIQUID ORAL 20120629 20210402 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA LYMPH; THYROID, PORCINE; ATROPA BELLADONNA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; SELENIUM; ASPIRIN; CORTICOTROPIN; CORTISONE ACETATE; EUGENOL; STEARYL ALCOHOL; XYLITOL; ESTRONE; BENZOIC ACID; CHLORINE; POTASSIUM SORBATE; SORBITOL; RESORCINOL; BENZYL ALCOHOL; LACTIC ACID, DL-; ISOPROPYL PALMITATE; BORIC ACID; ACETIC ACID; PHENYLBUTAZONE; PETROLATUM; LEAD 3; 3; 3; 3; 3; 3; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0065_78ebd73d-dfd3-4355-a719-40f6e5716e31 43742-0065 HUMAN OTC DRUG Enviro I Kali Gluconate, Glandula Suprarenalis Suis, Hepar Suis, Bamboo, Barley, Corn Levant Cotton, Flax Seed, Millet, Milo, Avena Sativa, Eschscholzia Californica, Oryza Sativa, Rye, Safflower, Sesamum, Soghum Bicolor, Glycine Max, Saccharum, Helianthus Annuus, Wheat, Coffea Tosta, Thea Sinensis, Carbo Vegetabilis Ferrum Iodatum, Ferrum Metallicum, Gelsemium Sempervirens, Iodium, Iridium Metallicum, Lycopodium Clavatum, Pulsatilla, Selenium Metallicum, Zincum Metallicum, Peanut, Black Walnut, English Walnut LIQUID ORAL 20120702 20180326 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. POTASSIUM GLUCONATE; SUS SCROFA ADRENAL GLAND; PORK LIVER; LOPHATHERUM GRACILE LEAF; BARLEY; CORN; LEVANT COTTON SEED; FLAX SEED; MILLET; SORGHUM BICOLOR WHOLE; OAT; ESCHSCHOLZIA CALIFORNICA; BROWN RICE; RYE; SAFFLOWER; SESAME SEED; SORGHUM; SOYBEAN; SUGARCANE; SUNFLOWER SEED; WHEAT; COFFEA ARABICA SEED, ROASTED; GREEN TEA LEAF; ACTIVATED CHARCOAL; FERROUS IODIDE; IRON; GELSEMIUM SEMPERVIRENS ROOT; IODINE; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; ANEMONE PULSATILLA WHOLE; SELENIUM; ZINC; PEANUT; BLACK WALNUT; ENGLISH WALNUT; BITTER ALMOND; CASHEW; COCONUT; PECAN; BRAZIL NUT; TOMATO; POTATO; BLACK PEPPER; EGGPLANT; CASEIN, STREPTOCOCCUS THERMOPHILUS CULTURED, PROPIONIBACTERIUM FREUDENREICHII SUBSP. SHERMANII CULTURED, AGED; COW MILK; BEEF; LAMB; PORK; CHICKEN; EGG; KIDNEY BEAN; ONION; MALUS DOMESTICA FLOWER; BANANA; ALPINE STRAWBERRY; ORANGE; PACIFIC COD; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; LIMULUS POLYPHEMUS; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; CORTISONE ACETATE; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; SEROTONIN; COCOA 8; 8; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 10; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 12; 30; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0066_a0522eb3-187f-469e-b373-e94bef314632 43742-0066 HUMAN OTC DRUG Estrogen Folliculinum, Oophorinum, LIQUID ORAL 20120710 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ESTRONE; SUS SCROFA OVARY 8; 8 [hp_X]/mL; [hp_X]/mL N 20181231 43742-0067_8f2e818b-3109-42e2-a010-54d763962b4a 43742-0067 HUMAN OTC DRUG Headache Cimicifuga racemosa, Gelsemium sempervirens, Rhus tox, LIQUID ORAL 20120710 20210812 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF 2; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0068_406ad76e-0fc9-4869-9313-d62cb9e86b58 43742-0068 HUMAN OTC DRUG Lymphoplus Trifolium pratense, Lymph (suis), Spleen (suis), Conium maculatum, Echinacea, Lycopodium clavatum, Myrrha, Phytolacca decandra, Selenium metallicum, Silicea, LIQUID ORAL 20120711 20190304 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TRIFOLIUM PRATENSE FLOWER; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHYTOLACCA AMERICANA ROOT; SELENIUM; SILICON DIOXIDE 3; 8; 8; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0069_f31ff653-7d3e-4852-b97f-f0dd11e761a2 43742-0069 HUMAN OTC DRUG Metab Ascorbicum Acidum, Cysteinum, Manganum Gluconate, Alpha-Ketoglutaricum Acidum, Fumaricum Acidum, Germanium Sesquioxide, Iodium, Magnesium Metallicum, Natrum Oxalaceticum, Pulsatilla, Thyroidinum (Suis), Vanadium Metallicum, LIQUID ORAL 20120710 20200702 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASCORBIC ACID; CYSTEINE; MANGANESE GLUCONATE; .ALPHA.-KETOGLUTARIC ACID; FUMARIC ACID; GERMANIUM SESQUIOXIDE; IODINE; MAGNESIUM; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; THYROID, PORCINE; VANADIUM 6; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0070_a2ad9e83-5828-432a-a09d-d63b3897eaf2 43742-0070 HUMAN OTC DRUG Pericardium Triple Warmer Meridian Formula Norepinephrine, Octopamine, Insulinum, Hydrocortisone, Ascorbic Acid, Glandula Suprarenalis Suis, Heart (Suis), Pituitaria Glandula, Sarcolacticum Acidum, Thyroidinum (Suis), Adrenocorticotrophin, Ubidecarenonum, Gaertner Bacillus, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Calcarea Carbonica, Glonoinum, Iodium, Kali Iodatum, Lachesis Mutus, Lithium Carbonicum, Lobelia Inflata, Mercurius Solubilis, Naja Tripudians, Phosphoricum Acidum, Phosphorus, Sepia, Spongia Tosta, Morgan Bacillus LIQUID ORAL 20120910 UNAPPROVED HOMEOPATHIC Deseret Biologicals NOREPINEPHRINE; OCTOPAMINE; INSULIN PORK; HYDROCORTISONE; ASCORBIC ACID; SUS SCROFA ADRENAL GLAND; PORK HEART; SUS SCROFA PITUITARY GLAND; LACTIC ACID, L-; THYROID, PORCINE; CORTICOTROPIN; UBIDECARENONE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; NITROGLYCERIN; IODINE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LITHIUM CARBONATE; LOBELIA INFLATA; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; PHOSPHORIC ACID; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SPONGIA OFFICINALIS SKELETON, ROASTED; PROTEUS MORGANII 6; 6; 15; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0071_e2a0c956-fe26-4b91-bed1-bd6b1edb1d0a 43742-0071 HUMAN OTC DRUG Cerebromax Acetylcholine Chloride, Adrenalinum, Dopamine, Gaba, Norepinephrine, Octopamine, Serotonin, Taurine, Adenosinum Cyclophosphoricum, Cerebrum (Suis), Diencephalon, Pineal Gland (Suis), Thalamus Opticus (Suis) LIQUID ORAL 20120815 20180401 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; EPINEPHRINE; DOPAMINE; .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; OCTOPAMINE; SEROTONIN; TAURINE; ADENOSINE CYCLIC 3',5'-PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0072_bf6506ae-7ba8-45c4-ab54-ee5c004a9cbe 43742-0072 HUMAN OTC DRUG Spinalmax Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Cuprum Aceticum, Nadidum, Natrum Oxalaceticum, Nicotinamidum, Picricum Acidum, Pyridoxinum, Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Alpha-Lipoicum Acidum, Ammonium Muriaticum, Cartilago Suis, Discus Intervertebralis (Suis), Silicea, Argentum Metallicum, Calcarea Phosphorica, Coenzyme A, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis LIQUID ORAL 20140402 20200913 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; CUPRIC ACETATE; NADIDE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PICRIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; .ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; COENZYME A; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SUS SCROFA BONE MARROW; MERCURIC OXIDE; SULFUR; ENTEROBACTER CLOACAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII; PROTEUS VULGARIS 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 28; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0073_beb13738-3381-46d8-93a1-be4d2a4b6c4d 43742-0073 HUMAN OTC DRUG Detox II Solidago Virgaurea, Baptisia Tinctoria, Berberis Vulgaris, Equisetum Hyemale, Argentum Nitricum 6X, Cantharis, Capsicum Annuum, Cuprum Sulphuricum, Orthosiphon Stamineus, Pareira Brava, Sarsaparilla, Terebinthina, Apis Venenum Purum, Barosma, Mercurius Corrosivus, Pyelon (Suis), Ureter (Suis), Urethra (Suis), Urinary Bladder (Suis), Glyoxal Trimer Dihydrate, Hepar Sulphuris Calcareum, Natrum Pyruvicum, Quercetin, Colibacillinum Cum Natrum Muriaticum, Dysentery Bacillus LIQUID ORAL 20120710 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SOLIDAGO VIRGAUREA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; SILVER NITRATE; LYTTA VESICATORIA; CAPSICUM; CUPRIC SULFATE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; TURPENTINE OIL; APIS MELLIFERA VENOM; AGATHOSMA BETULINA LEAF; MERCURIC CHLORIDE; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; GLYOXAL TRIMER DIHYDRATE; CALCIUM SULFIDE; SODIUM PYRUVATE; QUERCETIN; ESCHERICHIA COLI; SHIGELLA DYSENTERIAE 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0074_c10d32a0-f800-441a-82c3-a6d9686cbf32 43742-0074 HUMAN OTC DRUG Liver Drainage Berberis vulgaris, Chelidonium majus, Carduus marianus, Schisandra chinensis, Taraxacum officinale, Picrorhiza scrophulariiflora, Raphanus sativus, Viscum album, Chromium gluconate, Cobaltum gluconate, Copper gluconate, Magnesium gluconate, Natrum sulphuricum, LIQUID ORAL 20120711 20190428 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; SILYBUM MARIANUM SEED; SCHISANDRA CHINENSIS FRUIT; TARAXACUM OFFICINALE; RADISH; VISCUM ALBUM FRUITING TOP; CHROMIUM GLUCONATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; MAGNESIUM GLUCONATE; SODIUM SULFATE; PTELEA TRIFOLIATA BARK; LACTIC ACID, L-; SULFUR IODIDE; PHENOL; CICHORIUM INTYBUS FLOWER; SUS SCROFA GALLBLADDER; PORK LIVER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; VANADIUM; VERBENA OFFICINALIS FLOWERING TOP; NEOPICRORHIZA SCROPHULARIIFLORA ROOT 1; 1; 2; 2; 2; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0085_8ab8fda0-99ba-4a34-87a2-a8fe03f8c904 43742-0085 HUMAN OTC DRUG Gum Therapy Calendula Officinalis, Eugenia Caryophyllata, Plantago Major, Phytolacca Decandra, Arnica Montana, Phosphorus, Peptostreptococcus, Carbo Vegetabilis, Hepar Sulphuris Calcareum, Lachesis Mutus, Mercurius Solubilis LIQUID ORAL 20120803 20210421 UNAPPROVED HOMEOPATHIC Deseret Biologicals CALENDULA OFFICINALIS FLOWERING TOP; CLOVE; PLANTAGO MAJOR; PHYTOLACCA AMERICANA ROOT; ARNICA MONTANA; PHOSPHORUS; PEPTOSTREPTOCOCCUS ANAEROBIUS; ACTIVATED CHARCOAL; CALCIUM SULFIDE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS 1; 1; 1; 2; 3; 12; 15; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0086_751e9ef9-c392-49ba-bded-5c974b085d7a 43742-0086 HUMAN OTC DRUG Histamine Histaminum Hydrochloricum LIQUID ORAL 20120816 UNAPPROVED HOMEOPATHIC Deseret Biologials, Inc. HISTAMINE DIHYDROCHLORIDE 6 [hp_X]/mL N 20181231 43742-0088_f8c55bd9-698c-48c7-b10d-dbc878f63d35 43742-0088 HUMAN OTC DRUG Phenylalanine Phenylalanine LIQUID ORAL 20120816 20201013 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHENYLALANINE 6 [hp_X]/mL N 20181231 43742-0089_6fd4383c-a181-46cf-9a6e-3476b25aa495 43742-0089 HUMAN OTC DRUG Virus Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Spleen, Thymus LIQUID ORAL 20120815 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA, UNSPECIFIED; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM AQUATICUM; TABEBUIA IMPETIGINOSA BARK; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; ZINC; RANCID BEEF 3; 3; 3; 3; 3; 3; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0091_6c0c29a4-679c-4040-84cc-bd53a016bea5 43742-0091 HUMAN OTC DRUG Candida Candida Albicans LIQUID ORAL 20120822 20210216 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc CANDIDA ALBICANS 200 [hp_C]/mL N 20181231 43742-0092_05d927dd-122a-4d90-b1fb-1a5bc44d5d67 43742-0092 HUMAN OTC DRUG Energize RxS Sarcolacticum acidum, Viscum album, Iodium, Colchicum autumnale, Conium maculatum, Fucus vesiculosus, Galium aparine, Natrum oxalaceticum, Thyroidinum (suis), LIQUID ORAL 20120807 20180821 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LACTIC ACID, L-; VISCUM ALBUM FRUITING TOP; IODINE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; FUCUS VESICULOSUS; GALIUM APARINE; SODIUM DIETHYL OXALACETATE; THYROID, PORCINE; PRASTERONE; PHENYL ISOTHIOCYANATE; LIOTHYRONINE; TYRAMINE; .ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE; FUMARIC ACID; MALIC ACID; SUS SCROFA UMBILICAL CORD; PORK LIVER; SUS SCROFA BONE MARROW; SUS SCROFA PINEAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; CALCIUM FLUORIDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; CORTISONE ACETATE; MERCURIC CHLORIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; ESCHERICHIA COLI 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 8; 8; 12; 12; 12; 30; 60; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0095_8a288f08-899f-4335-9d38-a11e023457bc 43742-0095 HUMAN OTC DRUG Allermilk Hydrastis Canadensis, Taraxacum Officinale, Apiolum, Asparagine, Benzoicum Acidum, Cholinum, Cinnamic Acid, Coumarinum, Eugenol, Folic Acid, Folliculinum, Formalinum, GABA (Gamma-Aminobutyric Acid), Histaminum Hydrochloricum, Menadione, Octopamine, Oophorinum (Suis), Phenyl Isothiocyanate, Piperine, Progesterone, Quercetin, Rutin, Saccharum Lactis, Vanillylamine, Xanthine LIQUID ORAL 20120822 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GOLDENSEAL; TARAXACUM OFFICINALE; APIOLE (PARSLEY); ASPARAGINE; BENZOIC ACID; CHOLINE HYDROXIDE; CINNAMIC ACID; COUMARIN; EUGENOL; FOLIC ACID; ESTRONE; FORMALDEHYDE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE DIHYDROCHLORIDE; MENADIONE; OCTOPAMINE; SUS SCROFA OVARY; PHENYL ISOTHIOCYANATE; PIPERINE; PROGESTERONE; QUERCETIN; RUTIN; LACTOSE; VANILLYLAMINE; XANTHINE 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0096_2779df45-efe0-4876-91d0-c659e5bcde31 43742-0096 HUMAN OTC DRUG Energy Catalyst Viscum Album, Cobaltum Gluconicum, Cuprum Sulphuricum, Ferrous Fumaricum, Kali Asparaginicum, Magnesia Asparaginicum, Manganum Gluconicum LIQUID ORAL 20120823 20190812 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. VISCUM ALBUM FRUITING TOP; COBALTOUS GLUCONATE; CUPRIC SULFATE; FERROUS FUMARATE; POTASSIUM ASPARAGINATE; MAGNESIUM ASPARAGINATE; MANGANESE GLUCONATE; SODIUM MOLYBDATE; PHOSPHORUS; ADENOSINE CYCLIC 3',5'-PHOSPHATE; CEROUS OXALATE NONAHYDRATE; NICKEL ACETATE TETRAHYDRATE; CHOLECALCIFEROL; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; IRIDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; ALUMINUM OXIDE; MERCURIC CHLORIDE; PROTEUS MORGANII 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 200; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0097_d996a510-a5e0-483d-8a17-a998bb6d997a 43742-0097 HUMAN OTC DRUG Enviroclenz Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Stillingia Sylvatica, Taraxacum Officinals, Trifolium Pretense, Germanium Sesquioxide, Benzinum, Chlorinum, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Methanol, Belladonna, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20120822 20190428 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; STILLINGIA SYLVATICA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; GERMANIUM SESQUIOXIDE; BENZENE; CHLORINE; ACETONE; SODIUM TRIPOLYPHOSPHATE; PROPYLENE GLYCOL; TURPENTINE OIL; SODIUM BENZENESULFONATE; AMMONIUM CHLORIDE; SODIUM LAURYL SULFATE; METHYL ALCOHOL; ATROPA BELLADONNA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0099_0d85dc0f-296d-41ea-ac3e-2e672ee442ea 43742-0099 HUMAN OTC DRUG Hydration Complex Beta Vulgaris, Boldo, Carduus Benedictus, Chelidonium Majus, Coffea Tosta, Equisetum Arvense, Petroselinum Sativum, Taraxacum Officinale, Hypericum Perforatum, Ginkgo Biloba, Kali Muriaticum, Kali Phosphoricum, Kali Sulphuricum, Germanium Sesquioxide, Silicea, Calcarea Fluorica, Calcarea Phosphorica LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; PEUMUS BOLDUS LEAF; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; COFFEA ARABICA SEED, ROASTED; EQUISETUM ARVENSE TOP; PETROSELINUM CRISPUM; TARAXACUM OFFICINALE; HYPERICUM PERFORATUM; GINKGO; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; GERMANIUM SESQUIOXIDE; SILICON DIOXIDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE 1; 1; 1; 1; 1; 1; 1; 1; 3; 6; 6; 6; 6; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0100_89a081dc-16ec-4768-9052-72784e5ec170 43742-0100 HUMAN OTC DRUG Neuro II Hydrastis Canadensis, Taraxacum Officinale, Acetylcholine Chloride, Adrenalinum, Gaba, Histaminum Hydrochloricum LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GOLDENSEAL; TARAXACUM OFFICINALE; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE DIHYDROCHLORIDE; NOREPINEPHRINE; TYRAMINE 3; 3; 6; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0101_48e256d2-a64d-4eaf-ba2a-9370f61f5c32 43742-0101 HUMAN OTC DRUG Norepinephrine Norepinephrine LIQUID ORAL 20120824 20200819 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. NOREPINEPHRINE 6 [hp_X]/mL N 20181231 43742-0102_6e7c4dac-f1f0-4411-a55c-20ca8e25dee1 43742-0102 HUMAN OTC DRUG Professional Weight Support Asclepias Vincetoxicum, Echinacea, Hypothlamus (Suis), Hepar Suis, Methylcobalamin, Renal (Suis), Gambogia, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto Dehydroepiandrosterone, Adenosine Triphosphate, Glucagon, Insulin, Sarcolacticum Acidum, Proteus Bach LIQUID ORAL 20120823 20180725 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CYNANCHUM VINCETOXICUM ROOT; ECHINACEA, UNSPECIFIED; SUS SCROFA HYPOTHALAMUS; PORK LIVER; METHYLCOBALAMIN; PORK KIDNEY; GAMBOGE; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-OXO-PRASTERONE; ADENOSINE TRIPHOSPHATE; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS INCONSTANS 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0103_a46cb0eb-0af5-4def-8b00-249215623526 43742-0103 HUMAN OTC DRUG Systemic Detox Beta Vulgaris, Boldo, Chelidonium Majus, Sarsaparilla (Smilax Regelii), Gelsemium Sempervirens, Veratrum Album, Ferrum Metallicum, Iodium, Lycopodium Clavatum Nux Vomica, Pulsatilla (Vulgaris), Selenium Metallicum, Thuja Occidentalis, Zincum Metallicum LIQUID ORAL 20120827 20210510 UNAPPROVED HOMEOPATHIC Deseret Biologicals BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; SARSAPARILLA; GELSEMIUM SEMPERVIRENS ROOT; VERATRUM ALBUM ROOT; IRON; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ANEMONE PULSATILLA; SELENIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 3; 3; 3; 6; 7; 7; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0104_31201360-27e1-4edd-8b51-1923256c51c6 43742-0104 HUMAN OTC DRUG Metox Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense LIQUID ORAL 20120824 20190717 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GARLIC; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ASCORBIC ACID; CYSTEINE; METHIONINE; THYROID, PORCINE; ARSENIC TRIOXIDE; PHENOL; FORMALDEHYDE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; ANTIMONY TRISULFIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; CADMIUM; CERIUM; CHROMIUM; COBALT; COPPER; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; IRIDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; ALUMINUM OXIDE; MERCURIC CHLORIDE; PROTEUS MORGANII; OSMIUM; DYSPROSIUM 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0105_17c7e4cb-25b2-4965-b82d-87b2ae054440 43742-0105 HUMAN OTC DRUG Formaldehyde Formalinum LIQUID ORAL 20121228 20200729 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. FORMALDEHYDE 6 [hp_X]/mL N 20181231 43742-0130_b3f0f41c-8ac2-4ae7-bffd-329b659a6bce 43742-0130 HUMAN OTC DRUG Sinusitis Pulsatilla, Plantago Major, Euphorbium Officinarum, Luffa Operculata, Mercurius Iodatus Ruber, Mucosa Nasalis Suis, Argentum Nitricum LIQUID ORAL 20120906 20180905 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PULSATILLA VULGARIS; PLANTAGO MAJOR; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SUS SCROFA NASAL MUCOSA; SILVER NITRATE; CALCIUM SULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; SINUSITISINUM 2; 3; 4; 6; 8; 8; 10; 10; 12; 12; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0131_e86f793e-7b78-4e5b-981d-53fead337aac 43742-0131 HUMAN OTC DRUG Tobacco Avena Sativa, Lobelia Inflata, Cactus Grandiflorus, Tabacum, Gelsemium Sempervirens, Selenium Metallicum, Staphysagria, Vanadium Metallicum LIQUID ORAL 20120920 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AVENA SATIVA FLOWERING TOP; LOBELIA INFLATA; SELENICEREUS GRANDIFLORUS STEM; TOBACCO LEAF; GELSEMIUM SEMPERVIRENS ROOT; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; VANADIUM 1; 3; 4; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0132_ef514ee6-cf09-44c5-b93b-e9601cab8410 43742-0132 HUMAN OTC DRUG EBV Baptisia Tinctoria, Condurango, Echinacea, Hydrastis Canadensis, Nasturtium Aquaticum, Osha, Phytolacca Decandra, Tabebuia Impetiginosa, Astragalus Menziesii, Propolis, Glandula Suprarenalis Suis, Thymus (Suis), Aranea Diadema, Gelsemium Sempervirens, Ipecacuanha, Lycopodium Clavatum, Mercurius Solubilis, Muriaticum Acidum, Nitricum Acidum, Rhus Toxicodendron, Selenium Metallicum, Silicea, Epstein Barr Virus LIQUID ORAL 20120910 20180928 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BAPTISIA TINCTORIA; MARSDENIA CONDURANGO BARK; ECHINACEA, UNSPECIFIED; GOLDENSEAL; NASTURTIUM AQUATICUM; LIGUSTICUM PORTERI ROOT; PHYTOLACCA AMERICANA ROOT; TABEBUIA IMPETIGINOSA BARK; ASTRAGALUS NUTTALLII LEAF; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; ARANEUS DIADEMATUS; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; HYDROCHLORIC ACID; NITRIC ACID; TOXICODENDRON PUBESCENS LEAF; SELENIUM; SILICON DIOXIDE; HUMAN HERPESVIRUS 4 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0133_ed53a297-1327-4569-9fd4-981a9161ea00 43742-0133 HUMAN OTC DRUG Arthritis Joints Gnaphalium Polycephalum, Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Borax, Cuprum Aceticum, Kali Carbonicum, Pulsatilla, Secale Cornutum, Ammonium Muriaticum, Silicea, Argentum Metallicum, Calcarea Phosphorica, Glandula Suprarenalis Suis, Mercurius Praecipitatus Ruber, Sepia, Zincum Metallicum, Palladium Metallicum, Picricum Acidum, Sulphur, Cartilago Suis, Intervertebral Disc (Suis), Medulla Ossis Suis LIQUID ORAL 20120912 20200908 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PSEUDOGNAPHALIUM OBTUSIFOLIUM; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; SODIUM BORATE; CUPRIC ACETATE; POTASSIUM CARBONATE; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM; AMMONIUM CHLORIDE; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA ADRENAL GLAND; MERCURIC OXIDE; SEPIA OFFICINALIS JUICE; ZINC; PALLADIUM; PICRIC ACID; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA BONE MARROW 3; 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 8; 8; 10; 10; 10; 10; 10; 10; 12; 12; 30; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0134_6acda78e-26f4-4e35-9403-f5e2213e0da5 43742-0134 HUMAN OTC DRUG Asthma Plus Ribes Nigrum, Viburnum Opulus, Quebracho, Arsenicum Iodatum, Blatta Orientalis, Naphthalinum, Pothos Foetidus, Cinnamic Acid, Coumarinum, Gallicum Acidum, Indolum, Quercetin, Rutin, Dust Mite, Oxygenium, Malvin LIQUID ORAL 20120910 20210402 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BLACK CURRANT; VIBURNUM OPULUS BARK; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; ARSENIC TRIIODIDE; BLATTA ORIENTALIS; NAPHTHALENE; SYMPLOCARPUS FOETIDUS ROOT; CINNAMIC ACID; COUMARIN; GALLIC ACID; INDOLE; QUERCETIN; RUTIN; DERMATOPHAGOIDES FARINAE; OXYGEN; MALVIN 3; 3; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 9; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0135_e2cb5c91-b926-4bd4-bc9e-8615f514c50c 43742-0135 HUMAN OTC DRUG Bronchial Cough Coccus Cacti, Drosera, Scilla Maritima, Arsenicum Iodatum, Causticum, Cuprum Aceticum, Carbo Vegetabilis, Kali Carbonicum, Lachesis Mutus LIQUID ORAL 20120831 20181113 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PROTORTONIA CACTI; DROSERA ROTUNDIFOLIA; DRIMIA MARITIMA BULB; ARSENIC TRIIODIDE; CAUSTICUM; CUPRIC ACETATE; ACTIVATED CHARCOAL; POTASSIUM CARBONATE; LACHESIS MUTA VENOM 4; 4; 4; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0136_5bc41d23-dfec-42c8-b3f6-cf8a8cad7661 43742-0136 HUMAN OTC DRUG Ileocecal Valve Support Iodium, Pituitary (Suis), Thyroidinum (Suis), Glandula Suprarenalis Suis, Fel Tauri, Taraxacum Officinale, Bryonia, Carbo Vegetabilis, Colocynthis, Indolum, Lycopodium Clavatum, Mercurius Corrosivus, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris) LIQUID ORAL 20120905 20210422 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. IODINE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; SUS SCROFA ADRENAL GLAND; BOS TAURUS BILE; TARAXACUM OFFICINALE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CITRULLUS COLOCYNTHIS FRUIT PULP; INDOLE; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS 6; 8; 8; 10; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0137_69ec618c-870c-42c1-a8ff-84812e2b31fa 43742-0137 HUMAN OTC DRUG Inflammation Eupatorium Perfoliatum, Arnica Montana, Benzoicum Acidum, Echinacea, Mercurialis Perennis, Apis Mellifica, Baptisia Tinctoria LIQUID ORAL 20120905 20181125 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EUPATORIUM PERFOLIATUM FLOWERING TOP; ARNICA MONTANA; BENZOIC ACID; ECHINACEA, UNSPECIFIED; MERCURIALIS PERENNIS; APIS MELLIFERA; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; EUCALYPTUS GLOBULUS LEAF; SOLANUM NIGRUM WHOLE; TOXICODENDRON PUBESCENS LEAF 2; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0153_6c23f58f-6b3e-4a66-add5-96011c9f24f7 43742-0153 HUMAN OTC DRUG Bacteria Cochlearia armoracia, Echinacea, Hydrastis canadensis, Lomatium dissectum, tabebuia impetiginosa, adrenalinum, Hepar suis, Lymph (suis), Spleen (suis), LIQUID ORAL 20120917 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc HORSERADISH; ECHINACEA, UNSPECIFIED; GOLDENSEAL; TABEBUIA IMPETIGINOSA BARK; LOMATIUM DISSECTUM ROOT; EPINEPHRINE; PORK LIVER; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; THYROID, PORCINE; ARNICA MONTANA; ATROPA BELLADONNA; IRON; HYPERICUM PERFORATUM; IRIDIUM; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; ZINC 3; 3; 3; 3; 3; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0154_58d63b61-0ba4-40a7-aaf6-8b244d331d00 43742-0154 HUMAN OTC DRUG Electrolyte Plus Boricum gluconicum, Calcarea gluconica, Chromium gluconicum, Cobaltum gluconicum, Ferrum fluconicum, Kali gluconicum, Magnesia gluconica, LIQUID ORAL 20121009 20200701 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BORON GLUCONATE; CALCIUM GLUCONATE; COBALTOUS GLUCONATE; CHROMIUM GLUCONATE; COPPER GLUCONATE; FERROUS GLUCONATE; POTASSIUM GLUCONATE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; SODIUM GLUCONATE; NICKEL GLUCONATE; SELENIUM DIOXIDE; ZINC GLUCONATE; POTASSIUM PHOSPHATE, DIBASIC; VANADIUM; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0155_4aec6b20-c51b-4f9f-8b0f-b95c57c5f81c 43742-0155 HUMAN OTC DRUG ELEVATE RxS LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, BELLADONNA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN LIQUID ORAL 20120926 20180702 UNAPPROVED HOMEOPATHIC DESERET BIOLOGICALS, INC LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SEPIA OFFICINALIS JUICE; ATROPA BELLADONNA WHOLE; CAUSTICUM; PHOSPHORUS; SULFUR; OXITRIPTAN; ALUMINUM OXIDE; SILICON DIOXIDE; ACETYLCHOLINE CHLORIDE; DOPAMINE; NOREPINEPHRINE; PHENETHYLAMINE; SEROTONIN; ADENOSINE CYCLIC 3',5'-PHOSPHATE; SUS SCROFA CEREBRUM; COENZYME A; SUS SCROFA DIENCEPHALON; SUS SCROFA UMBILICAL CORD; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; ALCALIGENES FAECALIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS VULGARIS 3; 3; 3; 4; 4; 4; 4; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0156_7b452b85-c0d8-4485-98c5-2130bcf63cdc 43742-0156 HUMAN OTC DRUG Gallic Acid Gallicum acidum LIQUID ORAL 20120925 20200624 UNAPPROVED HOMEOPATHIC Deseret Biologicals GALLIC ACID 6 [hp_X]/mL N 20181231 43742-0157_61cefb2f-4fd1-4996-818e-1aeefe59a011 43742-0157 HUMAN OTC DRUG Joint Pain Arnica Montana, Bryonia, Causticum, Rhus Toxicodendron, Ferrum Phosphoricum LIQUID ORAL 20120920 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; TOXICODENDRON PUBESCENS LEAF; FERROSOFERRIC PHOSPHATE 4; 4; 4; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0158_71ec9f55-0d4b-4c5d-a64d-903a92b67d40 43742-0158 HUMAN PRESCRIPTION DRUG Progesterone Progesterone LIQUID ORAL 20120920 20201222 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PROGESTERONE 6 [hp_X]/mL Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 43742-0159_c3a6840c-b8a4-4fd1-bef6-c6d52df62fa4 43742-0159 HUMAN OTC DRUG Vax Reaction Mezereum, Thuja Occidentalis, Silicea, Calcarea Carbonica, Morbillinum, Parotidinum, Pertussinum, Poliomyelitis Nosode, Rubella Nosode, Tetanus Nosode, Carcinosin, Antimonium Crudum, Ledum Palustre, Thimerosal LIQUID ORAL 20120920 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DAPHNE MEZEREUM BARK; THUJA OCCIDENTALIS LEAF; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MEASLES VIRUS; MUMPS VIRUS; POLIOVIRUS; RUBELLA VIRUS; CLOSTRIDIUM TETANI; HUMAN BREAST TUMOR CELL; ANTIMONY TRISULFIDE; LEDUM PALUSTRE TWIG; THIMEROSAL 6; 6; 8; 30; 30; 30; 30; 30; 30; 15; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0160_c5bc8091-de3a-45b1-8e69-ae2222b4780d 43742-0160 HUMAN PRESCRIPTION DRUG Virus 2012 Belladonna, Bryonia, Eupatorium Perfoliatum, Gelsemium Sempervirens, Kreosotum, Veratrum Viride, Influenzinum LIQUID ORAL 20120920 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. WOOD CREOSOTE; ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; VERATRUM VIRIDE ROOT; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Live Attenuated Influenza A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Influenza Vaccines [Chemical/Ingredient],Vaccines, Attenuated [Chemical/Ingredient] N 20181231 43742-0161_2f522ef8-718e-4be9-bebd-e36782b8894b 43742-0161 HUMAN PRESCRIPTION DRUG Hormone Combination Salsolinol hydrochloride, Cholesterinum, Dehydroepiandrsterone, Folliculinum, Oophorinum (suis), Progesterone, Testosterone, Cortisone aceticum, Aldosterone, Androsterone, Follicle stimulating hormone, LIQUID ORAL 20120924 20190114 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SALSOLINOL HYDROCHLORIDE; CHOLESTEROL; PRASTERONE; ESTRONE; SUS SCROFA OVARY; PROGESTERONE; TESTOSTERONE; CORTISONE ACETATE; ALDOSTERONE; ANDROSTERONE; FOLLITROPIN 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient],Progesterone [Chemical/Ingredient],Progesterone [EPC],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 43742-0162_b4a49d19-6f51-4807-999e-3f13dfa3c9ba 43742-0162 HUMAN OTC DRUG Upper Respiratory Staph Step Combination Staphylococcus Aureus, Klebsiella Pneumoniae, Enterococcus Faecalis, Pneumococcinum, Streptococcus Agalactiae, Streptococcus Mutans, Haemophilus Influenzae B, Streptococcus Viridans LIQUID ORAL 20120910 20210601 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. STAPHYLOCOCCUS AUREUS; KLEBSIELLA PNEUMONIAE; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS MUTANS; HAEMOPHILUS INFLUENZAE TYPE B; STREPTOCOCCUS VIRIDANS GROUP 15; 15; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0163_b8a1e265-9639-4287-b4d5-a8bb50d8623e 43742-0163 HUMAN OTC DRUG Brucella Remedy Brucella Melitensis LIQUID ORAL 20120928 20210119 UNAPPROVED HOMEOPATHIC Deseret Biologicals BRUCELLA MELITENSIS 11 [hp_C]/mL N 20181231 43742-0164_01f7e666-929a-418f-a6e4-31226ed47bcc 43742-0164 HUMAN OTC DRUG Acetylcholine Chloride Acetylcholine Chloride LIQUID ORAL 20130911 20210210 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE 6 [hp_X]/mL N 20181231 43742-0165_4cb169fb-e0ff-4b2e-91cf-6dd1aed37c27 43742-0165 HUMAN PRESCRIPTION DRUG Addiclenz Beta Vulgaris, Boldo, Chelidonium Majus, Petroselinum Sativum, Taraxacum Officinale, Arsenicum Album, Belladonna, Cobaltum Metallicum, Cuprum Metallicum, Iodium, Lycopodium Clavatum, Phosphoricum Acidum, Selenium Metallicum, Zincum Metallicum, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methyl Paraben Propyl Paraben Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum LIQUID ORAL 20121113 20190507 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; PETROSELINUM CRISPUM; TARAXACUM OFFICINALE; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; COBALT; COPPER; IODINE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SELENIUM; ZINC; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 43742-0167_638d228f-3ff1-4001-8496-54da67329bc0 43742-0167 HUMAN OTC DRUG Ver Artemisia vulgaris, Filix mas, Cina, Melilotus officinalis, Quassia amara, Spigelia anthelmia, Teucrium marum, Thymus serpyllum, Siliceea, Calcarea carbonica, LIQUID ORAL 20121114 20191013 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARTEMISIA VULGARIS ROOT; DRYOPTERIS FILIX-MAS ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; MELILOTUS OFFICINALIS TOP; QUASSIA AMARA WOOD; SPIGELIA ANTHELMIA; TEUCRIUM MARUM; THYMUS SERPYLLUM; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; IODINE; MERCURIC CHLORIDE; SCHOENOCAULON OFFICINALE SEED; ASCARIS LUMBRICOIDES; TRICHINELLA SPIRALIS; ENTEROBIUS VERMICULARIS; TAENIA SOLIUM; TRICHOMONAS VAGINALIS; GIARDIA LAMBLIA; CRYPTOSPORIDIUM PARVUM; TAENIA SAGINATA; BRUGIA MALAYI 2; 2; 3; 3; 3; 3; 3; 3; 8; 12; 12; 12; 12; 12; 15; 15; 33; 12; 13; 18; 20; 20; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0168_bd71365b-6f14-4751-b377-56aac60b49d2 43742-0168 HUMAN OTC DRUG Dopamine Dopamine LIQUID ORAL 20121114 20180822 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DOPAMINE 6 [hp_X]/mL N 20181231 43742-0170_e663e2c9-af1c-44e5-a472-ca5fb62ab93d 43742-0170 HUMAN PRESCRIPTION DRUG Oratox Fucus Vesiculosus, Lymph Node, Medulla Ossis Suis, Thymus, Thyroidinum, Calcarea Muriatica, Iodium, Natrum Fluoratum, Natrum Muriaticum, Selenium Metallicum, Vanadium Metallicum, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Eugenol, Formalinum, Lidocaine, Mercurius Solubilis, Molybdenum Metallicum, Niccolum Metallicum, Palladium Metallicum, Stannum Metallicum, Titanium Metallicum, Zincum Metallicum, LIQUID ORAL 20121031 20201202 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. FUCUS VESICULOSUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA THYMUS; SUS SCROFA THYROID; CALCIUM CHLORIDE; IODINE; SODIUM FLUORIDE; SODIUM CHLORIDE; SELENIUM; VANADIUM; SILVER; GOLD; COPPER; EUGENOL; FORMALDEHYDE; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; TIN; TITANIUM; ZINC 3; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 43742-0171_7178afe7-9e54-4ecf-b5b4-2ae539723269 43742-0171 HUMAN OTC DRUG Skin Infections Ailanthus Glandulosus, Echinacea, Belladonna, Phytolacca Decandra, Hepar Sulphuris Calcareum, Mercurius Solubilis, Mezereum, Arsenicum Album, Lachesis Mutus, Herpes Simplex, Herpes Zoster LIQUID ORAL 20121031 UNAPPROVED HOMEOPATHIC Deseret Biologials, Inc. AILANTHUS ALTISSIMA FLOWERING TWIG; ECHINACEA ANGUSTIFOLIA; ATROPA BELLADONNA WHOLE; PHYTOLACCA AMERICANA ROOT; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; ARSENIC TRIOXIDE; LACHESIS MUTA VENOM; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 3 3; 3; 4; 4; 8; 8; 9; 12; 12; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0172_d76c09d0-d17b-483e-bbd0-9d3636a15264 43742-0172 HUMAN OTC DRUG Trauma Remedy Chamomilla, Echinacea (Angustifolia), Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Bryonia (Alba), Calendula Officinalis, Arnica Montana, Belladonna, Bellis Perennis, Rhus Tox, Clematis Vitalba flos, Helianthemum Nummularium flos, Hepar Sulphuris Calcareum, Impatiens Glandulifera flos, Ornithogalum Umbellatum flos, Prunus Cerasifera flos, Carbo Vegetabilis LIQUID ORAL 20121031 20210623 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; TOXICODENDRON PUBESCENS LEAF; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; CALCIUM SULFIDE; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; ACTIVATED CHARCOAL 3; 3; 3; 3; 3; 4; 4; 4; 6; 6; 6; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0173_0c463f60-72b4-48ff-9c22-123cbe429068 43742-0173 HUMAN OTC DRUG Candida Albicans Remedy Candida Albicans LIQUID ORAL 20121031 20210503 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CANDIDA ALBICANS 15 [hp_X]/mL N 20181231 43742-0174_1ec9d6be-04b5-4b17-a8f6-194eceac6827 43742-0174 HUMAN OTC DRUG Herpes Zoster Remedy Herpes Zoster Nosode LIQUID ORAL 20121106 20200925 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN HERPESVIRUS 3 15 [hp_X]/mL N 20181231 43742-0175_97399220-a71f-4f28-a222-f780d6b8e226 43742-0175 HUMAN OTC DRUG Gallbladder Liver Meridian Formula Cholesterinum, Histaminum Hydrochloricum, Menadione, Pyrrole, Alpha-Lipoicum Acidum, Ascorbicum Acidum, ATP, Fel Tauri, Gallbladder (Suis), Hepar Suis, Sarcolacticum Acidum, Adrenocorticotrophin, Arsenicum Album, Belladonna, Berberis Vulgaris, Bryonia, Calcarea Carbonica, Carduus Marianus, Cinchona Officinalis, Colocynthis, Kali Carbonicum, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus, Sepia, Morgan Gaertner LIQUID ORAL 20130911 20180626 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHOLESTEROL; HISTAMINE DIHYDROCHLORIDE; MENADIONE; PYRROLE; ALPHA LIPOIC ACID; ASCORBIC ACID; ADENOSINE TRIPHOSPHATE; BOS TAURUS BILE; SUS SCROFA GALLBLADDER; PORK LIVER; LACTIC ACID, L-; CORTICOTROPIN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILYBUM MARIANUM SEED; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0176_87d29e2e-e392-46cf-9152-c366348ce859 43742-0176 HUMAN OTC DRUG Virus Plus Influenzinum, Adenoviren Nosode, Herpes Simplex 1, Herpes Simplex 2, Cytomegalovirus, Epstein-Barr Virus Nosode, Hepatitis B Nosode LIQUID ORAL 20121002 20181127 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc INFLUENZA A VIRUS; INFLUENZA B VIRUS; HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4; HEPATITIS B VIRUS 12; 12; 15; 15; 15; 15; 18; 18; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0177_2b0e6f14-cfc8-4835-9565-69b15b239931 43742-0177 HUMAN OTC DRUG GI Drainage Cinnamomum, Gentiana Lutea, Syzygium Jambolanum, Argentum Nitricum, Colchicum Autumnale, Colostrum, Copper Gluconate, Lappa Major, Lycopodium Clavatum, Magnesium Gluconate, Manganese Gluconate, Nitricum Acidum, Pancreas Suis, Potassium Gluconate, Rumex Crispus, Schrophu8laria Nodosa, Stomach (Suis), Aurum Metallicum, Beech, Calcarea Carbonica, Carbo Vegetabilis, Cherry Plum, Crab Apple, Intestine (Suis), Rock Water LIQUID ORAL 20120928 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CINNAMON; GENTIANA LUTEA ROOT; SYZYGIUM CUMINI SEED; SILVER NITRATE; COLCHICUM AUTUMNALE BULB; BOS TAURUS COLOSTRUM; COPPER GLUCONATE; ARCTIUM LAPPA ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; NITRIC ACID; SUS SCROFA PANCREAS; POTASSIUM GLUCONATE; RUMEX CRISPUS ROOT; SCROPHULARIA NODOSA; SUS SCROFA STOMACH; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; FAGUS SYLVATICA FLOWERING TOP; PORK INTESTINE; MALUS SYLVESTRIS FLOWER; PRUNUS CERASIFERA FLOWER; WATER 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0178_ccc20c06-fd89-491f-9ab0-ee0432fe1176 43742-0178 HUMAN OTC DRUG GABA GABA, LIQUID ORAL 20121107 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .GAMMA.-AMINOBUTYRIC ACID 6 [hp_X]/mL N 20181231 43742-0179_61bfd841-02a7-41d5-b58b-983eadf16ecf 43742-0179 HUMAN OTC DRUG Sulphur Remedy Sulphur, Asclepias tuberosa, Bryonia, Dulcamara, LIQUID ORAL 20121012 20200915 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SULFUR; ASCLEPIAS TUBEROSA ROOT; BRYONIA ALBA ROOT; SOLANUM DULCAMARA STEM 4; 6; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0180_489a094f-b016-488e-9dca-2df4355072c7 43742-0180 HUMAN OTC DRUG Stomach Spleen Meridian Opener Arsenicum Album, Calcarea Carbonica, Carduus Marianus, Ceanothus Americanus, Cinchona Officinalis, Digitalis Purpurea, Ignatia Amara, Kali Bichromicum, Lycopodium Clavatum, Phosphorus, Plumbum Metallicum, Pulsatilla, Ranunculus Bulbosus, Veratrum Viride LIQUID ORAL 20130911 20200623 UNAPPROVED HOMEOPATHIC Desert Biologicals, Inc. ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILYBUM MARIANUM SEED; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; DIGITALIS; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; LEAD; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; VERATRUM VIRIDE ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0181_bb01431d-a033-449d-80af-b1a79794f125 43742-0181 HUMAN OTC DRUG hA2cg Evolution Ascelpias vincetoxicum, Echinacea, Hypothalamus (suis) Brain (suis), Hepar (suis), Methylcobalamin, Pancreas suis, Renal (suis), Stomach (suis), LIQUID ORAL 20120816 20180530 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CYNANCHUM VINCETOXICUM ROOT; ECHINACEA, UNSPECIFIED; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; METHYLCOBALAMIN; SUS SCROFA PANCREAS; PORK KIDNEY; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-OXO-PRASTERONE; ADENOSINE TRIPHOSPHATE; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0182_9dc2de97-1cbd-413d-a15d-92be92af8740 43742-0182 HUMAN OTC DRUG Herpes Simplex Remedy Herpes Simplex I, Herpes Simplex II LIQUID ORAL 20121012 20210121 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2 15; 15 [hp_X]/mL; [hp_X]/mL N 20181231 43742-0184_a55aa345-f580-4e54-bab2-3185af72a40d 43742-0184 HUMAN OTC DRUG Pre Dental Visit Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Veronica officinalis, Equisetum arvense, Fumaria officinalis, Geranium robertianum, Nasturtium aquaticum, LIQUID ORAL 20121012 20180418 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM ARVENSE TOP; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; SMILAX REGELII ROOT; ORNITHOGALUM UMBELLATUM FLOWERING TOP; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA LYMPH; SUS SCROFA THYROID 3; 3; 3; 3; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0185_b9aaee59-96ed-4041-a240-a9c3ee4cfae1 43742-0185 HUMAN OTC DRUG Coniferyl Alcohol Coniferyl Alcohol LIQUID ORAL 20121029 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CONIFERYL ALCOHOL 6 [hp_X]/mL N 20181231 43742-0186_4676688f-53ac-40d4-9bfa-20c05dc38a0c 43742-0186 HUMAN OTC DRUG Epinephrine Adrenalinum, LIQUID ORAL 20121012 20200811 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EPINEPHRINE 6 [hp_X]/mL N 20181231 43742-0187_99314e80-a94d-40ea-adcc-779730d9f35f 43742-0187 HUMAN OTC DRUG Trauma Relief Chamomilla, Echinacea, Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Bryonia, Calendula Officinalis GEL TOPICAL 20121026 20180416 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; ORNITHOGALUM UMBELLATUM FLOWERING TOP; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; TOXICODENDRON PUBESCENS LEAF; CALCIUM SULFIDE; ACTIVATED CHARCOAL 3; 3; 3; 3; 3; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43742-0188_8fb9d3e4-e379-4916-ad2a-d4c5e4d0b600 43742-0188 HUMAN OTC DRUG Acetaldehyde Acetaldehyde LIQUID ORAL 20121107 20201208 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETALDEHYDE 6 [hp_X]/mL N 20181231 43742-0189_ec002154-c62c-420f-87c2-f058b151fa07 43742-0189 HUMAN OTC DRUG Eye Sarcode Eye (Suis) LIQUID ORAL 20121029 20210121 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SUS SCROFA EYE 30 [hp_C]/mL N 20181231 43742-0190_0204ea82-46c5-4545-b8bd-c8f724282ba9 43742-0190 HUMAN OTC DRUG Female Support Chamomilla, Cimicifuga Racemosa, Cinchona Officinalis, Convallaria Majalis, Crocus Sativus, Helonias Dioica, Hydrastis Canadensis, Ledum Palustre, Mentha Piperita, Senna, Valeriana Officinalis, Viola Odorata, Agnus Castus, Lilium Tigrinum, Staphysagria, Cyclamen Europaeum, Cinnamonum, Murex Purpurea, Naja Tripudians LIQUID ORAL 20121114 20180503 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MATRICARIA RECUTITA; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; SAFFRON; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; LEDUM PALUSTRE TWIG; MENTHA PIPERITA; SENNA LEAF; VALERIAN; VIOLA ODORATA; CHASTE TREE; LILIUM LANCIFOLIUM WHOLE FLOWERING; DELPHINIUM STAPHISAGRIA SEED; CYCLAMEN PURPURASCENS TUBER; CINNAMON; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; NAJA NAJA VENOM 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 6; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0191_804841a3-f278-4b80-8a9a-c6141640ebd2 43742-0191 HUMAN OTC DRUG Malvin Malvin LIQUID ORAL 20121030 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MALVIN 15 [hp_C]/mL N 20181231 43742-0192_a346ba10-1408-434e-a405-5363357992bc 43742-0192 HUMAN OTC DRUG Epstein-Barr Virus Remedy Epstein-Barr Virus Nosode LIQUID ORAL 20121029 20200730 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN HERPESVIRUS 4 15 [hp_X]/mL N 20181231 43742-0193_fbbb8fbd-1e8a-4e3a-8ac6-cfb21ea59e88 43742-0193 HUMAN OTC DRUG Mycoplasma Remedy Mycoplasma Pneumoniae LIQUID ORAL 20121114 20210323 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MYCOPLASMA PNEUMONIAE 15 [hp_X]/mL N 20181231 43742-0194_b30bf7a8-07ba-4416-8a82-22e4be400b67 43742-0194 HUMAN OTC DRUG Governing Vessel Conception Vessel Meridian Opener Apis Mellifica, Arsenicum Album, Baryta Carbonica, Belladonna, Calcarea Carbonica, Cicuta Virosa, Conium Maculatum, Ferrum Metallicum, Lachesis Mutus, Lycopodium Clavatum, Mercurius Solubilis, Natrum Sulphuricum, Phosphorus, Pulsatilla, Sepia, Tarentula Hispana, Thuja Occidentalis LIQUID ORAL 20121227 20200819 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; ATROPA BELLADONNA WHOLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CICUTA VIROSA ROOT; CONIUM MACULATUM FLOWERING TOP; IRON; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; LYCOSA TARANTULA; THUJA OCCIDENTALIS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0196_800ee5e3-bd01-4256-9989-0efdb22cf7f9 43742-0196 HUMAN OTC DRUG HGH Vitality Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L Dopa, Melatonin, Testosterone, Alpha-Lipoicum Acidum, ATP, Coenzyme A, Coq10, Nadidum, Sarcolacticum Acidum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (Suis), Lymph (Suis) Medulla Ossis Suis, Oophorinum (Suis), Orchitinum (Suis), Pancreas Suis, Spleen (Suis), Human Growth Hormone, Morgan Pure LIQUID ORAL 20121226 20180927 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHASTE TREE; AMBERGRIS; CONIUM MACULATUM FLOWERING TOP; APIOLE (PARSLEY); ESTRADIOL; ESTRIOL; ESTRONE; LEVODOPA; MELATONIN; TESTOSTERONE; .ALPHA.-LIPOIC ACID; ADENOSINE TRIPHOSPHATE; COENZYME A; UBIDECARENONE; NADIDE; LACTIC ACID, L-; BARIUM CARBONATE; SELENIUM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SOMATROPIN; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0197_caff8ad0-b723-446e-aaf7-9637b8deb07d 43742-0197 HUMAN OTC DRUG Adrenal Support Aralia Quinquefolia, Humulus Lupulus, Adrenalinum, Cortisone Aceticum, Thyroidinum (Suis), Selenium Metallicum, Arsenicum Album, Calcarea Carbonica, Convallaria Majalis, Crotalus Horridus, Ferrum Metallicum, Nux Vomica, Phosphorus, Sepia, Phosphoricum Acidum LIQUID ORAL 20121114 20201106 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMERICAN GINSENG; HOPS; EPINEPHRINE; CORTISONE ACETATE; SUS SCROFA THYROID; SELENIUM; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; IRON; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE; PHOSPHORIC ACID 3; 3; 6; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0198_1cd45ee0-412c-4335-9863-778a06cc933a 43742-0198 HUMAN OTC DRUG Gallbladder Liver Meridian Opener Arsenicum Album, Berberis Vulgaris, Bryonia, Calcarea Carbonica, Carduus Marianus, Cinchona Officinalis, Kali Carbonicum, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus LIQUID ORAL 20121115 20210211 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILYBUM MARIANUM SEED; CINCHONA OFFICINALIS BARK; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0199_d8743f88-8964-4533-9536-36f5baec07fd 43742-0199 HUMAN OTC DRUG Bladder Kidney Meridian Formula Cinnamic Acid, Phloridzinum, alpha-Ketoglutaricum Acidum, Ascorbicum Acidum, Kidney (Suis), Malic Acid, Nicotinamidum, Urinary Bladder (Suis), Adrenocorticotrophin, Apis Mellifica, Argentum Nitricum, Berberis Vulgaris, Cantharis, Equisetum Arvense, Kali Bichromicum, Lycopodium Clavatum, Mercurius Solubilis, Natrum Muriaticum, Phosphorus, Rhus Tox, Sepia, Terebinthina, Thuja Occidentalis, Bacillus Faecalis, Proteus (Vulgaris), Dysentery Bacillus LIQUID ORAL 20121204 20200708 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CINNAMIC ACID; PHLORIZIN; .ALPHA.-KETOGLUTARIC ACID; ASCORBIC ACID; PORK KIDNEY; MALIC ACID; NIACINAMIDE; SUS SCROFA URINARY BLADDER; CORTICOTROPIN; APIS MELLIFERA; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; EQUISETUM ARVENSE TOP; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; TURPENTINE OIL; THUJA OCCIDENTALIS LEAF; ALCALIGENES FAECALIS; PROTEUS VULGARIS; SHIGELLA DYSENTERIAE 6; 6; 6; 6; 6; 6; 6; 6; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0200_358934a4-beff-449e-ab15-26b8e5a86e67 43742-0200 HUMAN OTC DRUG Lung Large Intestine Meridian Opener Aloe Socotrina, Alumina, Apis Mellifica, Arsenicum Album, Baryta Carbonica, Bryonia, Carbo Vegetabilis, Chamomilla, Kali Bichromicum, Phosphorus, Plumbum Metallicum, Pyrogenium, Sulphur LIQUID ORAL 20121115 20200805 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALOE; ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; POTASSIUM DICHROMATE; PHOSPHORUS; LEAD; RANCID BEEF; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0201_b5f4a6e7-edfe-45cb-a7df-32fc042ca7c1 43742-0201 HUMAN PRESCRIPTION DRUG Tyramine Tyramine LIQUID ORAL 20121116 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TYRAMINE 6 [hp_X]/mL N 20181231 43742-0202_e3aeb361-24e2-4d50-976f-4b8852e0875a 43742-0202 HUMAN OTC DRUG Kidney Bladder Support Equisetum Hyemale, Solidago Virgaurea, Cantharis, Kidney (Suis), Belladonna, Berberis Vulgaris, Calcarea Carbonica, Terebinthina, Apis Mellifica, Pulsatilla, Sepia, Staphysagria LIQUID ORAL 20130911 20201229 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EQUISETUM HYEMALE; SOLIDAGO VIRGAUREA FLOWERING TOP; LYTTA VESICATORIA; PORK KIDNEY; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TURPENTINE OIL; APIS MELLIFERA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED 3; 3; 6; 8; 12; 12; 12; 12; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0203_bbea3f00-c346-4071-97a6-f2472a34171a 43742-0203 HUMAN PRESCRIPTION DRUG Pertussis Aconitum Napellus, Antimonium Tartaricum, Belladonna, Bryonia, Hyoscyamus Niger, Ipecacuanha, Lobelia Inflata LIQUID ORAL 20121219 20181022 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; HYOSCYAMUS NIGER; IPECAC; LOBELIA INFLATA; LOBARIA PULMONARIA; WOOD CREOSOTE; PHOSPHORUS; SILICON DIOXIDE; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; CLOSTRIDIUM TETANI 4; 4; 4; 4; 4; 4; 4; 4; 5; 5; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0204_fe204994-9b3e-4dd2-b44d-dacd3f2fc48a 43742-0204 HUMAN OTC DRUG Petrochemical Detox Chelidonium Majus, Symphytum Officinale, Taraxacum Officinale, Trifolium Pratense, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Arsenicum Album, Cadmium Sulphuratum, Gelsemium Sempervirens, Iridium Metallicum, Lycopodium Clavatum, Mercurius Solubilis, Nitricum Acidum, Nitricum Acidum, Nux Vomica, Petroleum, Phosphoricum Acidum, Platinum Metallicum, Latrodectus Mactans LIQUID ORAL 20130906 30310209 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHELIDONIUM MAJUS; COMFREY ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; ACETONE; SODIUM TRIPOLYPHOSPHATE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; AMMONIUM CHLORIDE; SODIUM LAURYL SULFATE; TURPENTINE OIL; ARSENIC TRIOXIDE; CADMIUM SULFIDE; GELSEMIUM SEMPERVIRENS ROOT; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; LIQUID PETROLEUM; PHOSPHORIC ACID; PLATINUM; LATRODECTUS MACTANS 3; 3; 3; 3; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0205_a02d2040-67c7-40d6-8725-f774db2408c4 43742-0205 HUMAN OTC DRUG Melatonin Melatonin LIQUID ORAL 20121217 20210421 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MELATONIN 6 [hp_X]/mL N 20181231 43742-0206_c72cfc73-18c8-499e-a32d-2772076ab102 43742-0206 HUMAN OTC DRUG Virus 2000 Cedron, Lathyrus Sativus, Plumbum Metallicum, Arnica Montana, Arsenicum Album, Conium Maculatum, Eupatorium Perfoliatum LIQUID ORAL 20130108 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SIMABA CEDRON SEED; LATHYRUS SATIVAS SEED; LEAD; ARNICA MONTANA; ARSENIC TRIOXIDE; CONIUM MACULATUM FLOWERING TOP; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; TURPENTINE OIL 8; 9; 12; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0207_e3dbf982-a346-45ce-84e1-af31a2f0d5b6 43742-0207 HUMAN OTC DRUG Bladder Kidney Meridian Opener Apis Mellifica, Argentum Nitricum, Berberis Vulgaris, Cantharis, Equisetum Arvense, Kali Bichromicum, Lycopodium Clavatum, Mercurius Solubilis, Natrum Muriaticum, Phosphorus , Rhus Tox, Sepia, Terebinthina, Thuja Occidentalis LIQUID ORAL 20121228 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; EQUISETUM ARVENSE TOP; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; TURPENTINE OIL; THUJA OCCIDENTALIS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0208_d6814660-ae4e-4885-99bb-b929a93b7a5e 43742-0208 HUMAN OTC DRUG Carcinosin Carcinosin LIQUID ORAL 20121008 20200902 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN BREAST TUMOR CELL 30 [hp_C]/mL N 20181231 43742-0210_be64d33a-1928-4460-af10-b28d27116014 43742-0210 HUMAN OTC DRUG Female Stimulant Core Formula Aquilegia Vulgaris, Hydrastis Canadensis, Lilium Tigrinum, Bovista, Cypripedium Pubescens, Apiolum, Apis Venenum Purum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Heart (Suis), Kreosotum, Oophorinum (Suis), Uterus (Suis), Folliculinum, CIS-Aconitum Acid, Lachesis Mutus, Magnesia Phosphorica, Mercurius Solubilis, Sepia, Pineal Gland (Suis), Pituitaria Glandula (Suis), Estradiol, Progesterone, Testosterone, Placenta Totalis Suis, Bacillus Faecalis, Mutabile Bacillus (Bach) LIQUID ORAL 20130412 20190603 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AQUILEGIA VULGARIS; GOLDENSEAL; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPERDON UTRIFORME FRUITING BODY; CYPRIPEDIUM PARVIFOLUM ROOT; APIOLE (PARSLEY); APIS MELLIFERA VENOM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK HEART; WOOD CREOSOTE; SUS SCROFA OVARY; SUS SCROFA UTERUS; ESTRONE; ACONITIC ACID, (Z)-; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; SEPIA OFFICINALIS JUICE; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; ESTRADIOL; PROGESTERONE; TESTOSTERONE; SUS SCROFA PLACENTA; ALCALIGENES FAECALIS; ESCHERICHIA COLI 4; 4; 4; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 12; 13; 30; 30; 30; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0211_6bba7228-e46e-4fa5-b142-70c749f63197 43742-0211 HUMAN OTC DRUG Rutin Rutin LIQUID ORAL 20120227 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. RUTIN 6 [hp_X]/mL N 20181231 43742-0212_81a42657-5fbd-4ba1-b29b-8035c1dda385 43742-0212 HUMAN OTC DRUG Indole Indolum LIQUID ORAL 20130403 20200824 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. INDOLE 6 [hp_X]/mL N 20181231 43742-0213_70ef8ecd-68d9-47f4-afcf-935da8556117 43742-0213 HUMAN OTC DRUG Mineral Balancing and Energy Viscum Album, Cobaltum Gluconicum, Cuprum Sulphuricum, Ferrum Fumaricum, Kali Asparaginicum, Magnesia Asparaginicum, Manganum Gluconicum, Natrum Molybdanicum, Phosphorus, Adenosinum, Cyclophosphoricum, Cerium Oxalicum, Niccolum Aceticum, Vitamin D3, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium Metallicum LIQUID ORAL 20130405 20190717 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. VISCUM ALBUM FRUITING TOP; COBALTOUS GLUCONATE; CUPRIC SULFATE; FERROUS FUMARATE; POTASSIUM ASPARAGINATE; MAGNESIUM ASPARAGINATE; MANGANESE GLUCONATE; SODIUM MOLYBDATE; PHOSPHORUS; ADENOSINE CYCLIC PHOSPHATE; CEROUS OXALATE NONAHYDRATE; NICKEL ACETATE TETRAHYDRATE; CHOLECALCIFEROL; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC ACID; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; IRIDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; ALUMINUM OXIDE; MERCURIC CHLORIDE; PROTEUS MORGANII 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0214_e17703a0-cdaf-4bb8-a79c-0bf32c5ca463 43742-0214 HUMAN OTC DRUG Healing Support Betula Pendula, Cortex, Caltha Palustris, Galium Aparine, Sedum Acre, Thuja Occidentalis, Urtica Urens, Clematis Erecta LIQUID ORAL 20130422 20180913 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETULA PENDULA BARK; CALTHA PALUSTRIS; GALIUM APARINE; SEDUM ACRE; THUJA OCCIDENTALIS LEAF; URTICA URENS; CLEMATIS RECTA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; JUNIPERUS COMMUNIS WHOLE; ONONIS SPINOSA ROOT; QUILLAJA SAPONARIA BARK; SEMPERVIVUM TECTORUM LEAF; ECHINACEA, UNSPECIFIED; NITRIC ACID; SILVER; CALCIUM FLUORIDE; PHOSPHORUS; APIS MELLIFERA; RANCID BEEF 2; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0217_1917ea17-0cd9-4052-b69f-47502d3d232d 43742-0217 HUMAN OTC DRUG Quercetin Quercetin LIQUID ORAL 20130411 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. QUERCETIN 6 [hp_X]/mL N 20181231 43742-0218_3fbaee4a-abc2-4aff-b6e1-e7c91fd03ac6 43742-0218 HUMAN OTC DRUG Apiol Apiolum LIQUID ORAL 20130409 20210413 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIOLE (PARSLEY) 6 [hp_X]/mL N 20181231 43742-0219_aa63e451-d1f8-42e4-a56a-ad2f60f38e2e 43742-0219 HUMAN OTC DRUG Caffeic Acid Caffeic Acid LIQUID ORAL 20130408 20200527 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CAFFEIC ACID 6 [hp_X]/mL N 20181231 43742-0220_6c1939bd-7f97-4390-9ee9-ece2acabe52d 43742-0220 HUMAN OTC DRUG Lung Large Intestine Meridian Formula Coumarinum, Phenyl Isothiocyanate, Intestine (Suis), Ascorbic Acid, Coenzyme A, Ubidecarenonum, Colon (Suis), Lung (Suis), Riboflavinum, Sarcolacticum Acidum, Aloe, Alumina, Apis Mellifica, Arsenicum Album, Baryta Carbonica, Bryonia (Alba), Carbo Vegetabilis, Chamomilla, Kali Bichromicum, Phosphorus, Plumbum Metallicum, Pyrogenium, Sulphur LIQUID ORAL 20130416 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COUMARIN; PHENYL ISOTHIOCYANATE; PORK INTESTINE; ASCORBIC ACID; COENZYME A; UBIDECARENONE; SUS SCROFA COLON; SUS SCROFA LUNG; RIBOFLAVIN; LACTIC ACID, L-; ALOE; ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; POTASSIUM DICHROMATE; PHOSPHORUS; LEAD; RANCID BEEF; SULFUR; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 6; 6; 8; 6; 6; 6; 6; 6; 6; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0221_4ccfb24d-31a9-41aa-a292-1bf4c0de96f0 43742-0221 HUMAN OTC DRUG Pyrrole Pyrrole LIQUID ORAL 20130412 20201007 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PYRROLE 6 [hp_X]/mL N 20181231 43742-0222_be681f09-d2b9-474d-8c2f-febea4969dd8 43742-0222 HUMAN OTC DRUG Phenyl Isothiocyanate Phenyl Isothiocyanate LIQUID ORAL 20130412 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHENYL ISOTHIOCYANATE 6 [hp_X]/mL N 20181231 43742-0223_40ee11ce-d7b6-456c-a159-0082c6a8ef09 43742-0223 HUMAN OTC DRUG Detox III Conium Maculatum, Dulcamara, Echinacea, Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid, Coccus Cacti, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Pulsatilla, Sarcolacticum Acidum, Lymph (Suis), Sulphur, Glandula Suprarenalis Suis, Phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (Suis), Spleen (Suis), Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Funiculus Umbilicalis Suis, Tonsil (Suis), Gaertner Bach, Triiodothyronine LIQUID ORAL 20130531 20200925 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA ANGUSTIFOLIA; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; PULSATILLA VULGARIS; LACTIC ACID, L-; SUS SCROFA LYMPH; SULFUR; SUS SCROFA ADRENAL GLAND; PHENYLALANINE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA SPLEEN; CORTISONE ACETATE; MERCURIUS SOLUBILIS; BARIUM CARBONATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA TONSIL; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; LIOTHYRONINE; SUS SCROFA BONE MARROW; BISPHENOL A; BROMINE; CHLORINE; HYDROFLUORIC ACID; IODINE; ESCHERICHIA COLI 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 10; 10; 10; 10; 10; 13; 13; 28; 6; 6; 9; 10; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0224_19f366cb-2db4-495a-b3af-a32061b403cc 43742-0224 HUMAN OTC DRUG Chlorogenic Acid Chlorogenic Acid LIQUID ORAL 20130418 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHLOROGENIC ACID 30 [hp_X]/mL N 20181231 43742-0225_58ea4838-175d-4cf8-a57d-25111315cf56 43742-0225 HUMAN OTC DRUG Reflux RxS Acetyl Coenzyme A, ATP, Nadidum, Coumarinum, Argentum Nitricum, Ipecacuanha, Robinia Pseudoacacia, Sulphur LIQUID ORAL 20130424 20180701 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COENZYME A; ADENOSINE TRIPHOSPHATE; NADIDE; COUMARIN; SILVER NITRATE; IPECAC; ROBINIA PSEUDOACACIA BARK; SULFUR; STRYCHNOS NUX-VOMICA SEED; OREGANO LEAF OIL; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA UMBILICAL CORD; SUS SCROFA STOMACH; CENTAURIUM ERYTHRAEA; PEPSIN; HYDROCHLORIC ACID; ANHYDROUS CITRIC ACID; FORMIC ACID; LACTIC ACID, L-; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 10; 12; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0232_5ae0226d-e655-4328-a424-287f75024d75 43742-0232 HUMAN OTC DRUG Aspartame MSG Detox Chelidonium Majus, Phytolacca Decandra, Arnica Montana, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum, Bisphenol A (BPA), Dextrose, Maltodextrin, Sucralose, Aspartic Acid, Diketopiperazine, Dopamine, Formalinum, Formicum Acidum, Methyl Alcohol, Monosodium Glutamate, Phenylalanine LIQUID ORAL 20130612 20180625 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHELIDONIUM MAJUS; PHYTOLACCA AMERICANA ROOT; ARNICA MONTANA; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; BISPHENOL A; DEXTROSE; MALTODEXTRIN; SUCRALOSE; ASPARTIC ACID; 2,5-PIPERAZINEDIONE; DOPAMINE; FORMALDEHYDE; FORMIC ACID; METHYL ALCOHOL; MONOSODIUM GLUTAMATE; PHENYLALANINE 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0233_275a13a6-c917-42f2-b262-6f72c9f293e8 43742-0233 HUMAN OTC DRUG Mucous Membrane Core Formula Ceanothus Americanus, Hydrastis Canadensis, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (vulgaris), Bile Duct (suis), Colon (suis), Duodenum (suis), Esophagus (suis), Eye (suis), Gallbladder (suis), Ileum (suis), Intestine (suis), Ipecacuanha, Jejunum (suis), Kali Bichromicum, Lung (suis), Mucosa Nasalis suis, Natrum Oxalaceticum, Oral Mucosa (suis), Pancreas suis, Phosphorus, Rectal Mucosa (suis), LIQUID ORAL 20130503 20191021 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PULSATILLA VULGARIS; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTUM; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; ATROPA BELLADONNA WHOLE; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 4; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0234_d35772cd-77f3-44a3-80ba-fefeb38f644a 43742-0234 HUMAN OTC DRUG Cytomegalovirus Remedy Cytomegalovirus Nosode LIQUID ORAL 20130605 20210218 UNAPPROVED HOMEOPATHIC Deseret Biologicals HUMAN HERPESVIRUS 5 18 [hp_X]/mL N 20181231 43742-0235_02f4bc8c-7fbd-42b6-aa99-b5e3ea651efc 43742-0235 HUMAN OTC DRUG Influenza Grippe Nosode Influenzinum 2012, Respiratory Syncytial Virus LIQUID ORAL 20130605 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 9; 9; 9; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0236_ac2cfbbe-70d6-42b1-b8cf-2d4840676017 43742-0236 HUMAN OTC DRUG Lymph Drainage Citrus Limonum, Echinacea, Scrophularia Nodosa, Teucrium Scorodonia, Baptisia Tinctoria, Lobelia Inflata, Phytolacca Decandra, Pinus Sylvestris, Zincum Gluconicum, Thuja Occidentalis, Capsicum Annuum, Cuprum Gluconicum, Manganum Gluconicum, Aranea Diadema, Arsenicum Iodatum, Centaury, Hornbeam, Larch, Lymph (Suis), Spleen (Suis), Thymus (Suis), Lachesis Mutus LIQUID ORAL 20130515 20210510 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LEMON JUICE; ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; LOBELIA INFLATA; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; ZINC GLUCONATE; THUJA OCCIDENTALIS LEAF; CAPSICUM; COPPER GLUCONATE; MANGANESE GLUCONATE; ARANEUS DIADEMATUS; ARSENIC TRIIODIDE; CENTAURIUM ERYTHRAEA FLOWER; CARPINUS BETULUS FLOWER; LARIX DECIDUA FLOWERING TOP; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; LACHESIS MUTA VENOM 1; 1; 1; 1; 1; 3; 3; 3; 3; 4; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0237_75916093-54cf-4963-bd03-0363ec9bde75 43742-0237 HUMAN OTC DRUG Streptococcus Remedy Streptococcus Faecalis, Streptococcus Haemolyticus, Streptococcus Pneumoniae, Streptococcus Viridans, Streptococcus Mutans, Streptococcus Pyogenes LIQUID ORAL 20130614 20190304 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ENTEROCOCCUS FAECALIS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS VIRIDANS GROUP; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PYOGENES 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0238_a39b8d1e-7e7a-4690-974d-9ac343d2a8bb 43742-0238 HUMAN OTC DRUG Influenza Remedy Eucalyptus Globulus, Ipecacuanha, Aconitum Napellus LIQUID ORAL 20131016 UNAPPROVED HOMEOPATHIC Deseret Biologicals EUCALYPTUS GLOBULUS LEAF; IPECAC; ACONITUM NAPELLUS 2; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0239_637d0371-4e9b-4487-944b-eea83c600186 43742-0239 HUMAN OTC DRUG GRAIN MIX Coumarinum, Quercetin, Rutin, Bamboo, Barley, Corn, Gossypium herbaceum, Flax seed, Millet, Milo, Avena sativa, Eschscholzia californica, Oryza sativa, Rye, Safflower, Sesame, Sorghum bicolor, Glycine max, Saccharum officinarum, Helianthus annuus, Wheat LIQUID ORAL 20130801 20200327 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COUMARIN; QUERCETIN; RUTIN; BAMBUSA VULGARIS LEAF; BARLEY; CORN; GOSSYPIUM HERBACEUM SEED RESIN; FLAX SEED; MILLET; SORGHUM BICOLOR WHOLE; AVENA SATIVA WHOLE; ESCHSCHOLZIA CALIFORNICA; ORYZA SATIVA WHOLE; RYE; SAFFLOWER; SESAME SEED; GLYCINE MAX WHOLE; SACCHARUM OFFICINARUM WHOLE; HELIANTHUS ANNUUS FLOWERING TOP; WHEAT; AMARANTH; AVENA SATIVA FLOWERING TOP; SODIUM SULFATE; LACTIC ACID, L-; ELYMUS REPENS ROOT; CORTICOTROPIN; ENTEROCOCCUS FAECALIS 6; 6; 6; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 6; 6; 6; 6; 6; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0240_413dc156-30d3-4b80-8371-707f36edbdc4 43742-0240 HUMAN OTC DRUG Radiation Chondrus crispus, Fucus vesiculosus, Thyroidinum (suis), Cadmium iodatum, Iodium, Strontium carbonicum, X-Ray, LIQUID ORAL 20121213 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHONDRUS CRISPUS; FUCUS VESICULOSUS; THYROID, PORCINE; CADMIUM IODIDE; IODINE; STRONTIUM CARBONATE; ALCOHOL, X-RAY EXPOSED (1000 RAD); RADIUM BROMIDE 3; 3; 8; 12; 12; 12; 30; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0241_6f98e075-73c7-4527-a7f4-0d7ca8738854 43742-0241 HUMAN OTC DRUG YEAST MIX Acetaldehyde, Coumarinum, Histaminum Hydrochloricum, Quercetin, Torula Cerevisiae, Candida Albicans, Candida Parapsilosis, Adrenocorticotrophin, Sarcolacticum Acidum, Sepia, Faecalis (Alkaligenes) LIQUID ORAL 20130730 UNAPPROVED HOMEOPATHIC Deseret Biologicals ACETALDEHYDE; COUMARIN; HISTAMINE DIHYDROCHLORIDE; QUERCETIN; SACCHAROMYCES CEREVISIAE; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CORTICOTROPIN; LACTIC ACID, L-; SEPIA OFFICINALIS JUICE; ALCALIGENES FAECALIS 6; 6; 6; 6; 10; 12; 12; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0242_a5b93d1b-5363-4d96-9348-da5463b5e605 43742-0242 HUMAN OTC DRUG Celeragesic Echinacea, Echinacea Purpurea, Bellis Perennis, Calendula Officinalis, Hamamelis Virginiana, Acontium Napellus, Chamomilla, Hypericum Perforatum GEL TOPICAL 20130812 20180917 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACONITUM NAPELLUS; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; ATROPA BELLADONNA WHOLE; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; ADENOSINE TRIPHOSPHATE; COENZYME A; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; NADIDE; ORNITHOGALUM UMBELLATUM; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; LACTIC ACID, L-; COMFREY ROOT; UBIDECARENONE; ACTIVATED CHARCOAL; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; SUS SCROFA THALAMUS; PROTEUS MORGANII 2; 2; 2; 2; 2; 3; 3; 3; 3; 3; 4; 4; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g N 20181231 43742-0243_4023c7b3-c8f8-48a3-977b-d086db945e6b 43742-0243 HUMAN OTC DRUG KIDNEY DRAINAGE Solidago Virgaurea, Asparagus Officinalis, Juniperus Communis, Sabal Serrulata, Uva-Ursi, Berberis Vulgaris, Equisetum Arvense, Rhus Aromatic, Urtica Dioica, Cantharis, Rubia Tinctorum, Staphysagria, Cobaltum Metallicum, Fagus Sylvatica, Flos, Glandula Suprarenalis Suis, Hepar Sulphuris Calcareum, Kidney (Suis), Larix Deciduas, Flos, Manganum Metallicum, Mimulus Guttatus, Flos, Nitricum Acidum, Silicea, Ulex Europaeus, Flos, Benzoicum Acidum LIQUID ORAL 20130805 20201110 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SOLIDAGO VIRGAUREA FLOWERING TOP; ASPARAGUS; JUNIPERUS COMMUNIS WHOLE; SAW PALMETTO; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; EQUISETUM ARVENSE TOP; RHUS AROMATICA ROOT BARK; URTICA DIOICA; LYTTA VESICATORIA; RUBIA TINCTORUM ROOT; DELPHINIUM STAPHISAGRIA SEED; COBALT; FAGUS SYLVATICA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; CALCIUM SULFIDE; PORK KIDNEY; LARIX DECIDUA FLOWERING TOP; MANGANESE; MIMULUS GUTTATUS FLOWERING TOP; NITRIC ACID; SILICON DIOXIDE; ULEX EUROPAEUS FLOWER; BENZOIC ACID 1; 2; 2; 2; 2; 3; 3; 3; 3; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0244_a199eaa7-8a95-4913-87b8-891d625653a5 43742-0244 HUMAN OTC DRUG PERICARDIUM TRIPLE WARMER MERIDIAN OPENER Arsenic Album, Aurum Metallicum, Baryta Carbonica, Calcarea Carbonica, Glonoinum, Iodium, Kali Iodatum Lachesis Mutus, Lithium Carbonicum, Lobelia Inflata, Mercurius Solubilis, Naja Tripudians, Phosphoricum Acidum, Phosphorus, Sepia, Spongia Tosta, Thyroidinum (Suis) LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; NITROGLYCERIN; IODINE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LITHIUM CARBONATE; LOBELIA INFLATA; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; PHOSPHORIC ACID; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0245_483b2455-81b8-401d-ae38-02cdac10c5bd 43742-0245 HUMAN PRESCRIPTION DRUG Piperine Piperine LIQUID ORAL 20130809 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PIPERINE 6 [hp_X]/mL N 20181231 43742-0246_665b1193-796b-4b7d-93d8-06a0b8ab1a4c 43742-0246 HUMAN OTC DRUG Borrelia Babesia Remedy Babesia Microti, Borrelia Burgdorferi Nosode LIQUID ORAL 20130820 20200909 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BABESIA MICROTI; BORRELIA BURGDORFERI 15; 15 [hp_X]/mL; [hp_X]/mL N 20181231 43742-0247_0d5e7450-1530-4e84-83d8-ba176b86a745 43742-0247 HUMAN OTC DRUG Chronagesic Arnica Montana, Rhus Toxicodendron, Dulcamara, Sanguinaria Canadensis, Cartilago Suis, Coenzyme A, Funiculus Umbilicalis Suis LIQUID ORAL 20130813 20180913 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; SOLANUM DULCAMARA TOP; SANGUINARIA CANADENSIS ROOT; SUS SCROFA CARTILAGE; COENZYME A; SUS SCROFA UMBILICAL CORD; NADIDE; SODIUM DIETHYL OXALACETATE; SUS SCROFA PLACENTA; SULFUR; CHONDROITIN SULFATE SODIUM (BOVINE); DIMETHYL SULFONE; APIOLE (PARSLEY); CINNAMIC ACID; MENADIONE; PIPERINE; .ALPHA.-LIPOIC ACID; SILICON DIOXIDE; COMFREY ROOT; SOMATROPIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; ENTEROCOCCUS FAECALIS 1; 1; 2; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0248_ef7b56f3-4dc6-4db4-9cce-76317b91c163 43742-0248 HUMAN PRESCRIPTION DRUG Gyno Complex Viburnum Opulus, Magnesia Phosphorica, Folliculinum, Pulsatilla, Borax, Mercurius Solubilis, Nitricum Acidum, Silicea, Thuja Occidentalis LIQUID ORAL 20130820 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc VIBURNUM OPULUS BARK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ESTRONE; PULSATILLA VULGARIS; SODIUM BORATE; MERCURIUS SOLUBILIS; NITRIC ACID; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAF 3; 8; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 43742-0249_6cbf89ee-b399-4086-9b5d-087d348ff57b 43742-0249 HUMAN OTC DRUG Free Radical Alfalfa, Ascorbyl Palmitate, Cysteinum, Hordeum Vulgare, Laminaria Digitata, Manganese Gluconate, Methionine, Nasturtium Aquaticum, N,N-Dimethylglycine, Quercetin, Raphanus Sativus, Sodium Selenite, Triticum Aestivum, Coenzyme Q 10, Alpha-Lipoicum Acidum, Oryza Sativa, Vitamin E, Zinc Picolinate, Cobaltum Metallicum, Ferrum Metallicum, Glutathione, Magnesium Fluoratum, Selenium Metallicum, Zincum Metallicum, Alpha-Ketoglutaricum Acidum, Glyoxal LIQUID ORAL 20130822 20180618 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALFALFA; ASCORBYL PALMITATE; CYSTEINE; HORDEUM VULGARE TOP; LAMINARIA DIGITATA; MANGANESE GLUCONATE; METHIONINE; NASTURTIUM OFFICINALE; N,N-DIMETHYLGLYCINE; QUERCETIN; RAPHANUS SATIVUS; SODIUM SELENITE; TRITICUM AESTIVUM WHOLE; UBIDECARENONE; ALPHA LIPOIC ACID; BROWN RICE; .ALPHA.-TOCOPHEROL; ZINC PICOLINATE; COBALT; IRON; GLUTATHIONE; MAGNESIUM FLUORIDE; SELENIUM; ZINC; .ALPHA.-KETOGLUTARIC ACID; GLYOXAL 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0250_b3ce9c20-c45a-4154-bba8-c360a2a6ff79 43742-0250 HUMAN PRESCRIPTION DRUG Sugar Mix Cinnamic Acid, Phloridzinum, ATP, Argentum Nitricum, Beet Sugar, D-Ribose, Fructose, Dextrose, Grape Sugar (Syrup), Lycopodium Clavatum, LIQUID ORAL 20130822 20180611 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CINNAMIC ACID; PHLORIZIN; ADENOSINE TRIPHOSPHATE; SILVER NITRATE; SUCROSE; RIBOSE, D-; FRUCTOSE; DEXTROSE; LYCOPODIUM CLAVATUM SPORE; ACER SACCHARUM SAP; LACTOSE; LACTIC ACID, L-; CORTICOTROPIN; MALVIN; PROTEUS MORGANII; SHIGELLA DYSENTERIAE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] N 20181231 43742-0251_ee2a7159-5dac-4f93-81dc-458cb51eb433 43742-0251 HUMAN OTC DRUG Intestinal Distress Echinacea, Colchicum Autumnale, Aloe Socotrina, Colocynthis, Mercurius Corrosivus, Nux Vomica, Arsenicum Album, Chininum Sulphuricum LIQUID ORAL 20130821 20181112 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA, UNSPECIFIED; COLCHICUM AUTUMNALE BULB; ALOE; CITRULLUS COLOCYNTHIS FRUIT PULP; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED; ARSENIC TRIOXIDE; QUININE SULFATE; VIBRIO CHOLERAE; CAMPYLOBACTER JEJUNI; ESCHERICHIA COLI; HELICOBACTER PYLORI; SHIGELLA DYSENTERIAE; YERSINIA ENTEROCOLITICA; BOTULINUM TOXIN TYPE A; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 3; 4; 6; 6; 6; 6; 6; 12; 12; 30; 30; 30; 30; 30; 30; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0252_0f17e5c5-029e-4c04-9bda-08282c3ca41c 43742-0252 HUMAN OTC DRUG Glucagon Glucagon LIQUID ORAL 20130822 20200521 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GLUCAGON 8 [hp_X]/mL N 20181231 43742-0253_29fd0f99-523c-4a05-8ed9-dd7e6433d56d 43742-0253 HUMAN OTC DRUG Vascuflow RXS Cholesterinum, Formalinum, Gelsemium Sempervirens, Melatonin, Coumarinum, Arginine, Citrulline, Mercurius Corrosivus, Ubidecarenonum, Lanosterol, Mevalonolactone, Squalene, Calcarea Carbonica, Alpha-Lipoicum Acidum, Plumbum Metallicum, Coenzyme A, Glonoinum, Lycopodium Clavatum, Phosphorus, Berberis Vulgaris, Red Yeast Rice, Nitric Oxide, Morgan Pure, Rhus Tox LIQUID ORAL 20130916 20210219 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHOLESTEROL; FORMALDEHYDE; GELSEMIUM SEMPERVIRENS ROOT; MELATONIN; COUMARIN; ARGININE; CITRULLINE; MERCURIC CHLORIDE; UBIDECARENONE; LANOSTEROL; MEVALONOLACTONE, (+/-)-; SQUALENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; .ALPHA.-LIPOIC ACID; LEAD; COENZYME A; NITROGLYCERIN; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; BERBERIS VULGARIS ROOT BARK; RED YEAST; NITRIC OXIDE; PROTEUS MORGANII; TOXICODENDRON PUBESCENS LEAF 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 10; 6; 6; 6; 8; 8; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0256_127230ef-bbaf-47f4-b8c5-780f977dbee2 43742-0256 HUMAN OTC DRUG Hormone Mix System Formula DHEA (Dehydroepiandrosterone), Estrogen, Progesterone, Testosterone, Placenta Totalis Suis, Glandula Suprarenalis Suis, Oophorinum (Suis), Orchitinum (Suis), Sepia, Bacillus Faecalis LIQUID ORAL 20130918 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PRASTERONE; ESTRONE; ESTRIOL; ESTRADIOL; PROGESTERONE; TESTOSTERONE; SUS SCROFA PLACENTA; SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SEPIA OFFICINALIS JUICE; ALCALIGENES FAECALIS 30; 30; 30; 30; 30; 30; 6; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0257_4ae1ad07-31f8-4377-b3a7-d653b588cf7a 43742-0257 HUMAN OTC DRUG Male Stimulant Aralia Quinquefolia, Agnus Castus, Ascorbic Acid, Caladium Seguinum, Kali Bromatum, Strychninum Phosphoricum, Cantharis, Damiana, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Orchitinum, Pituitaria Glandula, LIQUID ORAL 20131021 20190603 UNAPPROVED HOMEOPATHIC Deseret Biologicals AMERICAN GINSENG; CHASTE TREE; ASCORBIC ACID; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; STRYCHNINE PHOSPHATE; LYTTA VESICATORIA; TURNERA DIFFUSA LEAFY TWIG; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; SUS SCROFA TESTICLE; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; CONIUM MACULATUM FLOWERING TOP; SUS SCROFA DIENCEPHALON; PORK HEART; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SELENIUM; ZINC; SUS SCROFA PINEAL GLAND; CORTISONE ACETATE; MANGANESE PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; TESTOSTERONE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 12; 13; 20; 28; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0290_fae6e98c-9dbb-4958-b6a3-6e58e1476c92 43742-0290 HUMAN OTC DRUG Neuro I Hydrastis Canadensis, Taraxacum Officinale, Dopamine, L-Dopa, Melatonin, Serotonin (Hydrochloride) LIQUID ORAL 20130904 20180806 UNAPPROVED HOMEOPATHIC Deseret Biologicals GOLDENSEAL; TARAXACUM OFFICINALE; DOPAMINE; LEVODOPA; MELATONIN; SEROTONIN HYDROCHLORIDE 3; 3; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0291_9b0b86ae-66fd-4be5-94e3-15e7c7f4dfb5 43742-0291 HUMAN OTC DRUG Cerebromax Acetylcholine Chloride, Adrenalinum, Dopamine, Gaba, Norepinephrine, Octopamine, Serotonin (Hydrochloride), Taurine, Adenosinum Cyclophosphoricum, Cerebrum (Suis), Diencephalon, Pineal Gland (Suis), Thalamus Opticus (Suis) LIQUID ORAL 20130904 20180626 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; EPINEPHRINE; DOPAMINE; .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; TAURINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBELLUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0292_dc8cc813-6041-4036-baec-5ac861294053 43742-0292 HUMAN OTC DRUG Enviro II Potassium Gluconate, Glandula Suprarenalis Suis, Hepar Suis, Canary Feathers, Standardized Cat Hair, Cattle Epithelia, Chicken Feathers, Dog Epithelia, Duck Feathers, Gerbil Epithelia, Goat Epithelia, Goose Feathers, Guinea Pig Epithelia, Hamster Epithelia, Hog Epithelia, Horse Epithelia, Mouse Epithelia, Parakeet Feathers, Rabbit Epithelia, Rat Epithelia, House, Mattress, Rug, Upholstery, Barley, Corn, Oat, Wheat, Rice, Millet, Milo, Dust Mite, Alfalfa, Golden Rod (Solidago Virguarea), Red Clover LIQUID ORAL 20130923 UNAPPROVED HOMEOPATHIC Deseret Biologicals POTASSIUM GLUCONATE; SUS SCROFA ADRENAL GLAND; PORK LIVER; SERINUS CANARIA FEATHER; FELIS CATUS HAIR; BOS TAURUS SKIN; GALLUS GALLUS FEATHER; CANIS LUPUS FAMILIARIS SKIN; ANAS PLATYRHYNCHOS FEATHER; MERIONES UNGUICULATUS SKIN; CAPRA HIRCUS SKIN; ANSER ANSER FEATHER; CAVIA PORCELLUS SKIN; MESOCRICETUS AURATUS SKIN; SUS SCROFA SKIN; EQUUS CABALLUS SKIN; MUS MUSCULUS SKIN; MELOPSITTACUS UNDULATUS FEATHER; ORYCTOLAGUS CUNICULUS SKIN; RATTUS NORVEGICUS SKIN; HOUSE DUST; BARLEY; CORN GRAIN; OAT; WHEAT; BROWN RICE; MILLET; SORGHUM BICOLOR WHOLE; DERMATOPHAGOIDES FARINAE; ALFALFA; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIFOLIUM PRATENSE FLOWER; FAGUS GRANDIFOLIA POLLEN; ULMUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; CARYA OVATA POLLEN; BETULA OCCIDENTALIS POLLEN; QUERCUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; FRAXINUS AMERICANA POLLEN; POA PRATENSIS TOP; DACTYLIS GLOMERATA TOP; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE TOP; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA PSILOSTACHYA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; ARSENIC TRIOXIDE; IRIDIUM; PHOSPHORUS; SELENIUM; SULFUR; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; SEROTONIN HYDROCHLORIDE 6; 8; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0294_0aedb8c1-0fec-413a-9873-16255f514dd6 43742-0294 HUMAN OTC DRUG Allergy Rescue Acetylcholine Chloride, Histaminum Hydrochloricum, Serotonin (Hydrochloride) LIQUID ORAL 20130930 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; HISTAMINE DIHYDROCHLORIDE; SEROTONIN HYDROCHLORIDE 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0295_7724980e-01f6-488b-a831-82d57d8e5df1 43742-0295 HUMAN OTC DRUG Serotonin Serotonin (Hydrochloride) LIQUID ORAL 20130930 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SEROTONIN HYDROCHLORIDE 6 [hp_X]/mL N 20181231 43742-0296_f1a7072e-874a-4f72-a042-dcb787f32a1a 43742-0296 HUMAN OTC DRUG Cinnamic Acid Cinnamic Acid LIQUID ORAL 20130930 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CINNAMIC ACID 6 [hp_X]/mL N 20181231 43742-0298_a00ca399-4cc5-4202-a05b-1eff68f241cd 43742-0298 HUMAN OTC DRUG Sore Throat Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla (Smilax Regelii), Calcarea Phosphorica, Ferrum Iodatum, Lymph Node (Suis), Thyroidinum (Suis) LIQUID ORAL 20131004 20210301 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; ARANEUS DIADEMATUS; SARSAPARILLA; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA LYMPH; SUS SCROFA THYROID 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 5; 5; 5; 6; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0299_bd43fa4d-55b0-4754-81eb-737f1e8ac475 43742-0299 HUMAN OTC DRUG Menadione Menadione LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC Deseret Biologicals MENADIONE 6 [hp_X]/mL N 20181231 43742-0300_5b2f1d47-f4a3-43ff-a62e-0553c9cd7e59 43742-0300 HUMAN OTC DRUG Enviro I Potassium Gluconate, Glandula Suprarenalis Suis, Hepar Suis, Bamboo, Barley, Corn, Levant Cotton, Flax, Millet, Milo, Oat, California Poppy, Rice, Rye, Safflower, Sesame, Sorghum, Soy Bean, Sugarcane, Sunflower (Helianthus Annuus), Wheat, Coffea Tosta, Thea Sinensis, Carbo Vegetabilis, Ferrum Iodatum, Ferrum Metallicum, Gelsemium Sempervirens, Iodium, Iridium Metallicum, Lycopodium Clavatum, Pulsatilla (Vulgaris), Selenium Metallicum, Zincum Metallicum, Allium Cepa, Amygdale Amara LIQUID ORAL 20140103 20200907 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. POTASSIUM GLUCONATE; SUS SCROFA ADRENAL GLAND; PORK LIVER; BAMBUSA VULGARIS LEAF; BARLEY; CORN; LEVANT COTTON SEED; FLAX SEED; MILLET; SORGHUM BICOLOR WHOLE; OAT; ESCHSCHOLZIA CALIFORNICA; BROWN RICE; RYE; SAFFLOWER; SESAME SEED; SORGHUM; SOYBEAN; SUGARCANE; SUNFLOWER SEED; WHEAT; COFFEA ARABICA SEED, ROASTED; GREEN TEA LEAF; ACTIVATED CHARCOAL; FERROUS IODIDE; IRON; GELSEMIUM SEMPERVIRENS ROOT; IODINE; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SELENIUM; ZINC; ONION; BITTER ALMOND; CASHEW; BANANA; BEEF; BLACK WALNUT; BRAZIL NUT; CASEIN, LACTOCOCCUS LACTIS CULTURED; CHICKEN; COCONUT; COD, UNSPECIFIED; EGG; EGGPLANT; ENGLISH WALNUT; ALPINE STRAWBERRY; COW MILK; LAMB; LIMULUS POLYPHEMUS; TOMATO; MALUS DOMESTICA FLOWER; ORANGE; OYSTER, UNSPECIFIED; PEANUT; PECAN; BLACK PEPPER; KIDNEY BEAN; POTATO; PORK; SALMON, UNSPECIFIED; SHRIMP, UNSPECIFIED; TUNA, UNSPECIFIED; CORTISONE ACETATE; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; SEROTONIN HYDROCHLORIDE; COCOA 6; 8; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 10; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0302_0de4bf52-3683-4b99-9424-2a8a7244e2e0 43742-0302 HUMAN OTC DRUG Brain Balance Core Formula Acetylcholine Chloride, Dopamine, Gaba, Octopamine, Serotonin, Taurine, Adenosinum Cyclophosphoricum, Cerebrum, Diencephalon, Pineal Gland, Thalamus Opticus LIQUID ORAL 20140103 20180718 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; DOPAMINE; .GAMMA.-AMINOBUTYRIC ACID; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; TAURINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0303_2f38346d-5b60-4f35-a6a2-f646a9f12b89 43742-0303 HUMAN PRESCRIPTION DRUG Salsolinol Salsolinol LIQUID ORAL 20140109 20191229 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SALSOLINOL 6 [hp_X]/mL N 20181231 43742-0304_e1f03c93-7b9d-449d-bf24-7e3f0f576c74 43742-0304 HUMAN OTC DRUG Octopamine Octopamine LIQUID ORAL 20140110 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. OCTOPAMINE 6 [hp_X]/mL N 20181231 43742-0305_770d0e24-330d-41b6-ac4e-8f7a4f129635 43742-0305 HUMAN OTC DRUG Bacteria Combination not applicable LIQUID ORAL 20140829 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE; MALIC ACID; SODIUM DIETHYL OXALACETATE; OROTIC ACID MONOHYDRATE; RIBOFLAVIN; APIOLE (PARSLEY); CINNAMIC ACID; STREPTOCOCCUS VIRIDANS GROUP; ESCHERICHIA COLI; ECHINACEA ANGUSTIFOLIA; HELICOBACTER PYLORI; MYCOPLASMA PNEUMONIAE; PROTEUS MIRABILIS; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; STREPTOCOCCUS PNEUMONIAE; YERSINIA ENTEROCOLITICA; STREPTOCOCCUS AGALACTIAE; LEGIONELLA PNEUMOPHILA; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS MUTANS; LISTERIA MONOCYTOGENES; SHIGELLA DYSENTERIAE; SHIGELLA SONNEI; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS PYOGENES; STREPTOCOCCUS UBERIS; PROTEUS MORGANII; STREPTOCOCCUS EQUINUS 6; 6; 6; 6; 6; 6; 6; 12; 15; 15; 15; 15; 15; 15; 15; 15; 17; 9; 11; 13; 13; 14; 15; 15; 15; 15; 15; 30; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0307_61b7c1c3-2d77-4f24-8a1a-858383a82e93 43742-0307 HUMAN OTC DRUG Phytolacca Phytolacca Decandra LIQUID ORAL 20140723 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHYTOLACCA AMERICANA ROOT 200 [hp_C]/mL N 20181231 43742-0308_c49bb259-c861-484f-ab4d-77636a1e95c4 43742-0308 HUMAN OTC DRUG Egg Mix System Formula Asparagine, Phenylalanine, Quercetin, Canary Feathers, Standardized Cat Hair, Cattle Epithelia, Chicken Feathers, Dog Epithelia, Duck Feathers, Gerbil Epithelia, Goat Epithelia, Goose Feathers, Guinea Pig Epithelia, Hamster Epithelia, Hog Epithelia, Horse Epithelia, Mouse Epithelia Parakeet Feathers, Rabbit Epithelia, Rat Epithelia, Ascorbic Acid, Calcarea Carbonica, Ferrum Iodatum, Tetracycline, Morgan Bacillus (Pure) LIQUID ORAL 20120620 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASPARAGINE; PHENYLALANINE; QUERCETIN; SERINUS CANARIA FEATHER; FELIS CATUS HAIR; BOS TAURUS SKIN; GALLUS GALLUS FEATHER; CANIS LUPUS FAMILIARIS SKIN; ANAS PLATYRHYNCHOS FEATHER; MERIONES UNGUICULATUS SKIN; CAPRA HIRCUS SKIN; ANSER ANSER FEATHER; CAVIA PORCELLUS SKIN; MESOCRICETUS AURATUS SKIN; SUS SCROFA SKIN; EQUUS CABALLUS SKIN; MUS MUSCULUS SKIN; MELOPSITTACUS UNDULATUS FEATHER; ORYCTOLAGUS CUNICULUS SKIN; RATTUS NORVEGICUS SKIN; ASCORBIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; TETRACYCLINE; PROTEUS MORGANII 6; 6; 6; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0309_b07fbf70-8650-44ad-9582-a1018d10ae53 43742-0309 HUMAN OTC DRUG Basic Detox Core Formula Carduus Marianus, Chelidonium Majus, Cinchona Officinalis, Lycopodium Clavatum, Taraxacum Officinale, Veratrum Album, Avena Sativa, Cynara Scolymus, Methylcobalamin, Menadione, alpha-Lipoicum Acidum, Hepar Suis, Colon (Suis), Duodenum (Suis), Gallbladder (Suis), Intestine (Suis), Lymph Node (Suis), Pancreas Suis, Thymus (Suis), alpha-Ketoglutaricum, Cholesterinum, Formicum Acidum, Glyoxal Trimer Dihydrate, Histaminum Hydrochloricum, Malic Acid, Natrum Oxalaceticum, Sulphur, Calcarea Carbonica, LIQUID ORAL 20140828 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MILK THISTLE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT; AVENA SATIVA FLOWERING TOP; CYNARA SCOLYMUS LEAF; METHYLCOBALAMIN; MENADIONE; .ALPHA.-LIPOIC ACID; PORK LIVER; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; PORK INTESTINE; SUS SCROFA LYMPH; SUS SCROFA PANCREAS; SUS SCROFA THYMUS; .ALPHA.-KETOGLUTARIC ACID; CHOLESTEROL; FORMIC ACID; GLYOXAL TRIMER DIHYDRATE; HISTAMINE DIHYDROCHLORIDE; MALIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; OROTIC ACID; PROTEUS MORGANII; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 3; 4; 4; 4; 4; 4; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 13; 28; 7; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0320_f3c1d032-40e1-46aa-901f-0f9a3cf40884 43742-0320 HUMAN OTC DRUG HGH Vitality Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-Dopa, Melatonin, Testosterone, Adenosinum Triphosphoricum Dinatrum, Alpha-Lipocicum Acidum, Coenzyme A, Co-Enzyme Q-10, Nadidum, Sarcolacticum Acidum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (Suis), Lymph (Suis), Medulla Ossis Suis, Oophorinum (Suis), Orichitinum (Suis), Pancreas Suis, Spleen (Suis), Human Growth Hormone, Morgan Bacillus TABLET ORAL 20150824 20201003 UNAPPROVED HOMEOPATHIC Deseret Biologicals CHASTE TREE; AMBERGRIS; CONIUM MACULATUM FLOWERING TOP; APIOLE (PARSLEY); ESTRADIOL; ESTRIOL; ESTRONE; LEVODOPA; MELATONIN; TESTOSTERONE; .ALPHA.-LIPOIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; COENZYME A; UBIDECARENONE; NADIDE; LACTIC ACID, L-; BARIUM CARBONATE; SELENIUM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SOMATROPIN; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 N 20181231 43742-0321_128b17fe-5cba-499b-8701-5552dcdf8185 43742-0321 HUMAN OTC DRUG Bartonella Remedy Bartonella Bacilliformis, Bartonella Clarridgeiae, Bartonella Elizabethae, Bartonella Henselae, Bartonella Quintana, Bartonella Vinsonii, Bartonella Washoensis, LIQUID ORAL 20140425 20200916 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BARTONELLA BACILLIFORMIS; BARTONELLA CLARRIDGEIAE; BARTONELLA HENSELAE; BARTONELLA ELIZABETHAE; BARTONELLA QUINTANA; BARTONELLA VINSONII; BARTONELLA WASHOENSIS 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0322_c92b2029-d418-49b7-a7de-fe4943009080 43742-0322 HUMAN OTC DRUG Trauma Relief Gel Chamomilla, Echinacea, Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Bryonia (Alba), Calendula Officinalis, Symphytum Officinale, Arnica Montana, Belladonna, Bellis Perennis, Clematis Vitalba, Flos, Helianthemum Nummularium Flos, Impatiens Glandulifera Flos, Ornithogalum Umbellatum Flos, Prunus Cerasifera Flos, Rhus Tox, Hepar Sulphuris Calcareum, Carbo Vegetabilis GEL TOPICAL 20130805 20200803 UNAPPROVED HOMEOPATHIC Deseret Biologicals MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ARNICA MONTANA; ATROPA BELLADONNA WHOLE; BELLIS PERENNIS; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF; CALCIUM SULFIDE; ACTIVATED CHARCOAL 3; 3; 3; 3; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43742-0323_f68eeb67-a229-4c15-9a3a-bbdadae94dc6 43742-0323 HUMAN OTC DRUG Bug Bouncer Grindelia (Robusta), Urtica Urens, Ledum Palustre, Staphysagria, Cedron LIQUID ORAL 20140612 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GRINDELIA HIRSUTULA WHOLE; URTICA URENS; LEDUM PALUSTRE TWIG; DELPHINIUM STAPHISAGRIA SEED; SIMABA CEDRON SEED 1; 1; 4; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0324_b24f6454-7cc2-4bb9-a168-98d3abc5fcf3 43742-0324 HUMAN OTC DRUG Bio Tonico not applicable LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. QUININE ARSENITE; CHAMAELIRIUM LUTEUM ROOT; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SELENIUM; GOLD 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0325_64feb339-c70a-44ae-bbe4-02be3be6d1cd 43742-0325 HUMAN OTC DRUG Bio Lymphomyosot not applicable LIQUID ORAL 20140829 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; NASTURTIUM AQUATICUM; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS REGIA FLOWERING TOP; ARANEUS DIADEMATUS; SMILAX REGELII ROOT; ASCORBIC ACID; QUERCETIN; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA THYROID; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 5; 5; 6; 6; 6; 6; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0326_3bd9a82c-244c-47e8-8973-933e61b901c7 43742-0326 HUMAN OTC DRUG Bio Viscum Compositum not applicable LIQUID ORAL 20140903 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. VISCUM ALBUM FRUITING TOP; SEROTONIN HYDROCHLORIDE; TRYPTOPHAN; ADENOSINE CYCLIC PHOSPHATE; MERCUROUS IODIDE 3; 6; 6; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0338_fb611011-bd77-4741-a28a-83481932caf2 43742-0338 HUMAN OTC DRUG Bio Thalamus Compositum not applicable LIQUID ORAL 20140829 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE CYCLIC PHOSPHATE; APIOLE (PARSLEY); LEVODOPA; MELATONIN; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; VISCUM ALBUM FRUITING TOP 6; 6; 6; 6; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0339_1ecc2838-059a-465e-be68-a9fecec2b9ef 43742-0339 HUMAN OTC DRUG Condylomata Remedy Human papilloma nosode, LIQUID ORAL 20140621 20201117 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN PAPILLOMAVIRUS 15 [hp_X]/mL N 20181231 43742-0340_25d5ae9a-5298-45c7-abd9-0390170e5136 43742-0340 HUMAN OTC DRUG Toxoplasma Gondii Remedy Toxoplasma Gondii LIQUID ORAL 20140715 20201214 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TOXOPLASMA GONDII 15 [hp_X]/mL N 20181231 43742-0341_6d79d4fe-871c-4b19-8a8e-70441d6b05c6 43742-0341 HUMAN OTC DRUG Elevate RXS Lycopodium Clavatum, Natrum Muriaticum, Sepia, Belladonna, Causticum, Phosphorus, Sulphur, 5-Hydroxytryptophan, Alumina, Silicea, Acetylcholine Chloride, Dopamine Hydrochloride, Norepinephrine, Phenylethylamine, Serotonin (Hydrochloride), Adenosinum Cyclophosphoricum, Cerebrum (Suis), Coenzyme A, Diencephalon (Suis), Funiculus Umbilicalis Suis, Pineal Gland (Suis), Sarcolacticum Acidum, Faecalis Bach, Gaertner Bacillus (Bach), Proteus (Vulgaris) LIQUID ORAL 20140402 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SEPIA OFFICINALIS JUICE; ATROPA BELLADONNA; CAUSTICUM; PHOSPHORUS; SULFUR; OXITRIPTAN; ALUMINUM OXIDE; SILICON DIOXIDE; ACETYLCHOLINE CHLORIDE; DOPAMINE HYDROCHLORIDE; NOREPINEPHRINE; PHENETHYLAMINE; SEROTONIN HYDROCHLORIDE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; COENZYME A; SUS SCROFA DIENCEPHALON; SUS SCROFA UMBILICAL CORD; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; ALCALIGENES FAECALIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS VULGARIS 3; 3; 3; 4; 4; 4; 4; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0342_0bd93215-495e-490b-b582-84913fcf5f94 43742-0342 HUMAN OTC DRUG Neuro I Hydrastis Canadensis, Taraxacum Officinale, Dopamine (Hydrochloride), L-Dopa, Melatonin, Serotonin LIQUID ORAL 20130904 20210331 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GOLDENSEAL; TARAXACUM OFFICINALE; DOPAMINE HYDROCHLORIDE; LEVODOPA; MELATONIN; SEROTONIN HYDROCHLORIDE 3; 3; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0343_37d07a70-49fb-4a5a-853e-bf67fe464d00 43742-0343 HUMAN OTC DRUG Cerebromax Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, Gaba, Norepinephrine, Octopamine, Serotonin (Hydrochloride), Taurine, LIQUID ORAL 20130904 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; EPINEPHRINE; DOPAMINE HYDROCHLORIDE; .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; TAURINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0344_4f1f1c36-c842-4ff2-9981-fc3102042ff2 43742-0344 HUMAN OTC DRUG Brain Balance Core Formula Acetylcholine chloride, Dopamine hydrochloride, GABA (Gamma-aminobutyric acid), Octopamine, Serotonin (Hydrochloride), Taurine, LIQUID ORAL 20140515 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; DOPAMINE HYDROCHLORIDE; .GAMMA.-AMINOBUTYRIC ACID; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; TAURINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0355_2f16585a-0cad-4d37-b542-b083e54c3298 43742-0355 HUMAN OTC DRUG Perfect Sleep Adenosinum Triphosphoricum Dinatrum, Coenzyme A, Co-Enzyme Q-10, Pineal Gland (Suis), Sarcolacticum Acidum, Melatonin, Pyrrole, Tryptophan, Arsenicum Album, Avena Sativa, Chamomilla, Coffea Cruda, Mercurius Corrosivus, Passiflora Incarnata, Silicea, Zincum Valerianicum, Dysentery Bacillus, Gaertner Bacillus TABLET ORAL 20140401 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; COENZYME A; UBIDECARENONE; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; MELATONIN; PYRROLE; TRYPTOPHAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE; ZINC VALERATE DIHYDRATE; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1 N 20181231 43742-0356_654e6d9b-0da9-4516-a5f1-59e2d8e0e28f 43742-0356 HUMAN OTC DRUG Professional Weight Support Asclepias vincetoxicum, Echinacea (angustifolia), Hypothalamus (suis), Hepar suis, Kidney (suis) Methylcobalamin, Gambogia, Graphites, Nux vomica, Phytolacca decandra, 7-KETO-DHEA (Dehydroepiandrosterone), Adenosinum triphosphoricum dinatrum, Glucagon, Insulinum, Sarcolacticum acidum, Proteus (vulgaris) LIQUID ORAL 20140303 20210303 UNAPPROVED HOMEOPATHIC Desert Biologicals, Inc. CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; GAMBOGE; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0357_e3c8730a-3351-49ce-9b52-e175c970bace 43742-0357 HUMAN OTC DRUG BIO GALLIUM NOT APPLICABLE LIQUID ORAL 20141010 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETULA PENDULA BARK; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; GALIUM APARINE; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; CORTISONE ACETATE; SILVER; CALCIUM FLUORIDE; PHOSPHORUS; GOLD; APIS MELLIFERA; ONONIS SPINOSA WHOLE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 5; 6; 6; 8; 8; 8; 10; 12; 5; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0358_345594f5-1edf-4bf0-9183-37577adef4e6 43742-0358 HUMAN OTC DRUG BIO UBICHINON COMPOSITUM Colchicum Autumnale, Conium Maculatum, Hydrastis Canadensis, Vaccinium Myrtillus, Podophyllum Peltatum, Ascorbic Acid, Galium Aparine, Nicotinamidum, Pyridoxinum Hydrochloricum, Riboflavinum, Sarcolacticum Acidum, Thiaminum Hydrochloricum, Norepinephrine, Alpha-Lipoicum Acidum, Natrum Oxalaceticum, Sulphur, Acetylsalicylicum Acidum, Anthraquinone, Adenosinum Triphosphoricum Disodium, Coenzyme A, Co-Enzyme Q-10, Histaminum Hydrochloricum, Magnesium Gluconate, Nadidum, Naphthoquinone, LIQUID ORAL 20141007 20181024 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; BILBERRY; PODOPHYLLUM; ASCORBIC ACID; GALIUM APARINE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; LACTIC ACID, L-; THIAMINE HYDROCHLORIDE; NOREPINEPHRINE; .ALPHA.-LIPOIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; ASPIRIN; ANTHRAQUINONE; ADENOSINE TRIPHOSPHATE DISODIUM; COENZYME A; UBIDECARENONE; HISTAMINE DIHYDROCHLORIDE; MAGNESIUM GLUCONATE; NADIDE; 1,4-NAPHTHOQUINONE; MANGANESE PHOSPHATE, DIBASIC; HYDROQUINONE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 4; 4; 4; 5; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0359_509516c1-0c07-458c-b262-23b9c410b5a4 43742-0359 HUMAN OTC DRUG Bio Placenta Compositum Aesculus Hippocastanum, Sarcolacticum Acidum, Secale Cornutum, Cuprum Sulphuricum, Melilotus Officinalis, Placenta Totalis Suis, Solanum Nigrum, Strophanthus Hispidus, DHEA (Dehydroepiandrosterone), Quercetin, Rutin, Natrum Pyruvicum, Vein (Suis), Artery (Suis), Funiculus Umbilicalis Suis, Tabacum, Vipera Berus, Bartya Carbonica, Plumbum Iodatum, Astragalus Exscapus, Proteus (Vulgaris) LIQUID ORAL 20140903 20181030 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HORSE CHESTNUT; LACTIC ACID, L-; CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC SULFATE; MELILOTUS OFFICINALIS TOP; SUS SCROFA PLACENTA; SOLANUM NIGRUM WHOLE; STROPHANTHUS HISPIDUS SEED; PRASTERONE; QUERCETIN; RUTIN; SODIUM PYRUVATE; SUS SCROFA VEIN; SUS SCROFA ARTERY; SUS SCROFA UMBILICAL CORD; TOBACCO LEAF; VIPERA BERUS VENOM; BARIUM CARBONATE; LEAD IODIDE; ASTRAGALUS EXSCAPUS WHOLE FLOWERING/FRUITING; PROTEUS VULGARIS 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 10; 10; 10; 10; 13; 18; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0360_ba685a36-b078-40de-84f2-ea32b9d5570a 43742-0360 HUMAN OTC DRUG Bio Tonsilla Compositum not applicable LIQUID ORAL 20140829 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA ANGUSTIFOLIA; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; PULSATILLA VULGARIS; LACTIC ACID, L-; ACETYLCHOLINE CHLORIDE; YEAST MANNAN; SUS SCROFA LYMPH; SULFUR; TRIBASIC CALCIUM PHOSPHATE; FERRUM PHOSPHORICUM; SUS SCROFA UMBILICAL CORD; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA BONE MARROW; SUS SCROFA SPLEEN; CORTISONE ACETATE; SUS SCROFA ADRENAL GLAND; MERCURIUS SOLUBILIS; SUS SCROFA THYROID; BARIUM CARBONATE; SUS SCROFA TONSIL 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 10; 10; 10; 10; 10; 10; 10; 13; 13; 13; 13; 28; 28 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0361_6c08c982-2e28-4aaf-8b71-6591d77e9afb 43742-0361 HUMAN OTC DRUG Bio Glyoxal not applicable LIQUID ORAL 20140904 20181022 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; TOXICODENDRON PUBESCENS LEAF; ECHINACEA ANGUSTIFOLIA; SANGUINARIA CANADENSIS ROOT; BRYONIA ALBA ROOT; EUPHORBIA RESINIFERA RESIN; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; CORTISONE ACETATE; DOPAMINE HYDROCHLORIDE; SILVER NITRATE; ARSENIC TRIOXIDE; MERCURIC CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; GLYOXAL; CALCIUM SULFIDE; LACHESIS MUTA VENOM; PYRUVALDEHYDE; ZINC 3; 4; 4; 4; 5; 5; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0362_21d5b565-2b2f-4829-9e36-1f428d0dc379 43742-0362 HUMAN OTC DRUG BIO CO-ENZYME COMPOSITUM Beta Vulgaris, Ascorbic Acid, Cysteinum, Natrum Oxalaceticum, Nicotinamidum, Pulsatilla (Vulgaris), Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Adrenalinum, Alpha Ketoglutaricum Acidum, Alpha Lipoicum Acidum, Cerium Oxalicum LIQUID ORAL 20141013 20181016 UNAPPROVED HOMEOPATHIC Deseret Biolgicals, Inc. BETA VULGARIS; ASCORBIC ACID; CYSTEINE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; EPINEPHRINE; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; CEROUS OXALATE NONAHYDRATE; ACONITIC ACID, (Z)-; ANHYDROUS CITRIC ACID; COENZYME A; FUMARIC ACID; MAGNESIUM OROTATE; MALIC ACID; NADIDE; SODIUM PYRUVATE; SUCCINIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; CALCIUM SULFIDE; SULFUR; MANGANESE PHOSPHATE, DIBASIC; BARIUM OXALOSUCCINATE; PROTEUS MORGANII 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 16; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0363_2984a000-dafa-442f-a4db-c7352c778e7e 43742-0363 HUMAN OTC DRUG Gallbladder Liver Meridian Formula Cholesterinum, Histaminum Hydrochloricum, Menadione, Pyrrole, Alpha-Lipoicum Acidum, Ascorbic Acid, Adenosinum Triphosphoricum Dinatrum, Fel Tauri, Gallbladder (suis), Hepar Suis, Sarcolacticum Acidum, Adrenocorticotrophin, Arsenicum Album, Belladonna, Berberis Vulgaris, Bryonia (alba), Calcarea Carbonica, Carduus Marianus, Cinchona Officinalis, Colocynthis, Kali Carbonicum, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus, Sepia, Morgan Gaertner LIQUID ORAL 20131016 20201007 UNAPPROVED HOMEOPATHIC Deseret Biologicals CHOLESTEROL; HISTAMINE DIHYDROCHLORIDE; MENADIONE; PYRROLE; .ALPHA.-LIPOIC ACID; ASCORBIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; BOS TAURUS BILE; SUS SCROFA GALLBLADDER; PORK LIVER; LACTIC ACID, L-; CORTICOTROPIN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILYBUM MARIANUM SEED; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 43742-0364_78063f7b-41dc-467f-97fb-568b094ab14e 43742-0364 HUMAN OTC DRUG Reflux RXS Acetyl Coenzyme A, Adenosinum Triphosphoricum Dinatrum, Nadidum, Coumarinum, Argentum Nitricum, Ipecacuanha, Robinia Pseudoacacia, Sulphur, Nux Vomica, Origanum Vulgare, Duodenum (Suis), Esophagus (Suis), Funiculus Umbilicalis Suis, Stomach (Suis), Erythraea Centaurium, Pepsinum, Muriaticum Acidum, Citricum Acidum, Formicum Acidum, Sarcolacticum Acidum, Morgan Bacillus LIQUID ORAL 20140228 20210127 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYL COENZYME A; ADENOSINE TRIPHOSPHATE DISODIUM; NADIDE; COUMARIN; SILVER NITRATE; IPECAC; ROBINIA PSEUDOACACIA BARK; SULFUR; STRYCHNOS NUX-VOMICA SEED; OREGANO; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA UMBILICAL CORD; SUS SCROFA STOMACH; CENTAURIUM ERYTHRAEA; PEPSIN; HYDROCHLORIC ACID; ANHYDROUS CITRIC ACID; FORMIC ACID; LACTIC ACID, L-; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 10; 12; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0365_c05fad08-b740-4118-b5d5-6a6e572e0a88 43742-0365 HUMAN OTC DRUG HA2CG EVOLUTION Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Brain (Suis), Hepar Suis, Methylcobalamin, Pancreas Suis, Kidney (Suis), Stomach (Suis), AACG-A, AACG-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-KETO-DHEA, Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum, Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20140527 20200430 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; METHYLCOBALAMIN; SUS SCROFA PANCREAS; PORK KIDNEY; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0366_71f7c11e-f4ec-459e-a773-bddc764031f3 43742-0366 HUMAN OTC DRUG Celeragesic Echinacea (Angustifolia), Echinacea Purpurea, Bellis Perennis, Calendula Officinalis, Hamamelis Virginiana, Aconitum Napellus, Chamomilla, Hypericum Perforatum, Belladonna, Millefolium, Bryonia (Alba), Arnica Montana, Rhus Tox, Adenosinum Triphosphoricum Dinatrum, Clematis Vitalba Flos, Coenzyme A, Ubidecarenonum, Helianthemum Nummularium Flos, Hepar Sulphuris Calcareum, Impatiens Glandulifera Flos, Mercurius Solubilis, Nadidum, Ornithogalum Umbellatum Flos, Prunus Cerasifera Flos LIQUID ORAL 20140417 20210210 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACONITUM NAPELLUS; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; ATROPA BELLADONNA; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; ADENOSINE TRIPHOSPHATE DISODIUM; CLEMATIS VITALBA FLOWER; COENZYME A; HELIANTHEMUM NUMMULARIUM FLOWER; CALCIUM SULFIDE; IMPATIENS GLANDULIFERA FLOWER; MERCURIUS SOLUBILIS; NADIDE; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; LACTIC ACID, L-; COMFREY ROOT; UBIDECARENONE; ACTIVATED CHARCOAL; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; PROTEUS MORGANII 2; 2; 2; 2; 2; 3; 3; 3; 3; 3; 4; 4; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0367_56b8ff32-a260-4466-902e-3661c0baa3a5 43742-0367 HUMAN OTC DRUG Perfect Sleep Adenosinum Triphosphoricum Dinatrum, Coenzyme A, Pineal Gland (suis), Sarcolacticum Acidum, Ubidecarenonum, Melatonin, Pyrrole, Tryptophan, Arsenicum album, Avena Sativa, Chamomilla, Coffea Cruda, Mercurius Corrosivus, Passiflora Incarnata, Silicea, Zincum Valerianicum, Dysentery Bacillus, Gaertner Bacillus (Bach) LIQUID ORAL 20140331 20201110 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; COENZYME A; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; UBIDECARENONE; MELATONIN; PYRROLE; TRYPTOPHAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE; ZINC VALERATE DIHYDRATE; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0368_a388f78e-2589-4a59-bdb2-82066bc60587 43742-0368 HUMAN OTC DRUG Human Parvovirus Remedy Parvovirus Nosode (B19) LIQUID ORAL 20140714 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc HUMAN PARVOVIRUS B19 15 [hp_X]/mL N 20181231 43742-0369_82bf1541-d769-4fab-8175-97ef1b8c184c 43742-0369 HUMAN OTC DRUG Sugar Mix Cinnamic Acid, Phloridzinum, Argentum Nitricum, Adenosinum Triphosphoricum Dinatrum, Beet Sugar, Dextrose, D-Ribose, Fructose, Grape Sugar (Syrup), Lycopodium Clavatum, Maple Sugar, Saccharum Lactis, Saccharum Officinale, Sarcolaticum Acidum, Adrenocorticotrophin, Malvin, Morgan Gaertner, Dysentery Bacillus LIQUID ORAL 20140428 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CINNAMIC ACID; PHLORIZIN; SILVER NITRATE; ADENOSINE TRIPHOSPHATE DISODIUM; SUCROSE; DEXTROSE; RIBOSE, D-; FRUCTOSE; LYCOPODIUM CLAVATUM SPORE; ACER SACCHARUM SAP; LACTOSE; LACTIC ACID, L-; CORTICOTROPIN; MALVIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0370_4f62cd6f-22a5-4c34-a0d8-10d92d3291b6 43742-0370 HUMAN PRESCRIPTION DRUG Pre Dental Visit Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Arvense, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum LIQUID ORAL 20140709 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM ARVENSE TOP; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; NASTURTIUM AQUATICUM; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; SARSAPARILLA; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA LYMPH; SUS SCROFA THYROID 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 5; 5; 5; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 43742-0371_16098273-bb98-4857-8088-f31172c8b3c5 43742-0371 HUMAN OTC DRUG BACTERIA COMBINATION NOT APPLICABLE LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; MALIC ACID; SODIUM DIETHYL OXALACETATE; OROTIC ACID MONOHYDRATE; RIBOFLAVIN; APIOLE (PARSLEY); CINNAMIC ACID; STREPTOCOCCUS VIRIDANS GROUP; ESCHERICHIA COLI; ECHINACEA, UNSPECIFIED; HELICOBACTER PYLORI; MYCOPLASMA PNEUMONIAE; PROTEUS MIRABILIS; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; STREPTOCOCCUS PNEUMONIAE; YERSINIA ENTEROCOLITICA; STREPTOCOCCUS AGALACTIAE; LEGIONELLA PNEUMOPHILA; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS MUTANS; LISTERIA MONOCYTOGENES; SHIGELLA DYSENTERIAE; SHIGELLA SONNEI; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS PYOGENES; STREPTOCOCCUS UBERIS; PROTEUS MORGANII; STREPTOCOCCUS EQUINUS 6; 6; 6; 6; 6; 6; 6; 12; 15; 15; 15; 15; 15; 15; 15; 15; 17; 9; 11; 13; 13; 14; 15; 15; 15; 15; 15; 30; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0372_78f9c702-e80c-4198-bed4-a467ada97a76 43742-0372 HUMAN OTC DRUG HGH Vitality Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-Dopa, Melatonin, Testosterone, Alpha-Lipoicum Acidum, Adenosinum Triphosphoricum Dinatrum, Coenzyme A, Ubidecarenonum, Nadidum, Sarcolacticum Acidum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (Suis), Lymph Node(Suis), Medulla Ossis Suis, Oophorinum (Suis), Orchitinum (Suis), Pancreas Suis, Spleen (Suis) LIQUID ORAL 20140220 20201218 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHASTE TREE; AMBERGRIS; CONIUM MACULATUM FLOWERING TOP; APIOLE (PARSLEY); ESTRADIOL; ESTRIOL; ESTRONE; LEVODOPA; MELATONIN; TESTOSTERONE; .ALPHA.-LIPOIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; COENZYME A; UBIDECARENONE; NADIDE; LACTIC ACID, L-; BARIUM CARBONATE; SELENIUM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SOMATROPIN; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0373_37448ccc-a22c-4ed1-960f-2e7063959294 43742-0373 HUMAN OTC DRUG CALCIUM MIX SYSTEM FORMULA NOT APPLICABLE LIQUID ORAL 20141007 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIOLE (PARSLEY); ASPARAGINE; BENZOIC ACID; CHOLINE HYDROXIDE; CINNAMIC ACID; COUMARIN; EUGENOL; FOLIC ACID; ESTRONE; FORMALDEHYDE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE DIHYDROCHLORIDE; LACTOSE; MENADIONE; OCTOPAMINE; SUS SCROFA OVARY; PHENYL ISOTHIOCYANATE; PIPERINE; QUERCETIN; RUTIN; VANILLYLAMINE; XANTHINE; LACTIC ACID, L-; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; TOXICODENDRON PUBESCENS LEAF; CALCIUM CITRATE; CALCIUM GLUCONATE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0374_f782ab29-43c5-4d1b-a353-166e25d0f82a 43742-0374 HUMAN OTC DRUG Stomach Acid System Formula Coumarinum, Citricum Acidum, Formicum Acidum, Muriaticum Acidum, Oleander, Ptelea Trifoliata, Sarcolacticum Acidum, Sulphur, Adrenocorticotrophin, Morgan Bacillus (Pure) LIQUID ORAL 20141009 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COUMARIN; ANHYDROUS CITRIC ACID; FORMIC ACID; HYDROCHLORIC ACID; NERIUM OLEANDER LEAF; PTELEA TRIFOLIATA BARK; LACTIC ACID, L-; SULFUR; CORTICOTROPIN; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 8; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0375_fe71149e-5af1-4b37-8dd0-bcca7d849d27 43742-0375 HUMAN OTC DRUG Sinusitis Plus with ENT Support Kali muriaticum, Calcarea sulphurica, Sulphur, Mucor racemosus, Hydrastis canadensis, Kali bichromicum, Lachesis mutus, Mercurius sulphuratus ruber, LIQUID ORAL 20140428 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. POTASSIUM CHLORIDE; CALCIUM SULFATE ANHYDROUS; SULFUR; MUCOR RACEMOSUS; GOLDENSEAL; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MERCURIC SULFIDE; CALCIUM SULFIDE; SILVER NITRATE; COBALT; COPPER; MANGANESE; SILICON DIOXIDE; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; THUJA OCCIDENTALIS LEAFY TWIG; SINUSITISINUM 6; 10; 6; 6; 7; 7; 7; 7; 7; 10; 10; 10; 10; 10; 10; 10; 10; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0376_d204ab7b-9186-45dc-8fa0-5aea9d5b5c7a 43742-0376 HUMAN OTC DRUG VITAMIN C MIX NOT APPLICABLE LIQUID ORAL 20141003 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETALDEHYDE; CINNAMIC ACID; GALLIC ACID MONOHYDRATE; HESPERADIN; MALVIN; QUERCETIN; RUTIN; CHLOROPHYLL; ACETIC ACID; ARSENIC TRIOXIDE; ASCORBIC ACID; OXALIC ACID; LACTIC ACID, L-; CORTICOTROPIN; SHIGELLA DYSENTERIAE 6; 6; 6; 6; 6; 6; 6; 10; 6; 6; 6; 6; 6; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0377_1e1c3143-e7d1-4559-be66-38b806aa6012 43742-0377 HUMAN OTC DRUG Celeragesic Echinacea (Angustifolia), Echinacea Purpurea, Bellis Perennis, Calendula Officinalis, Hamamelis Virginiana, Aconitum Napellus, Chamomilla, Hypericum Perforatum, Belladonna, Millefolium, Bryonia (Alba), Arnica Montana, Rhus Tox, Adenosinum Triphosphoricum Dinatrum, Clematis Vitalba Flos, Coenzyme A, Helianthemum Nummularium Flos, Hepar Sulphuris Calcareum, Impatiens Glandulifera Flos, Mercurius Solubilis, Nadidum, Ornithogalum Umbellatum Flos, Prunus Cerasifera, Flos, Sarcolacticum Acidum GEL TOPICAL 20140512 20201223 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACONITUM NAPELLUS; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; ATROPA BELLADONNA; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; ADENOSINE TRIPHOSPHATE DISODIUM; CLEMATIS VITALBA FLOWER; COENZYME A; HELIANTHEMUM NUMMULARIUM FLOWER; CALCIUM SULFIDE; IMPATIENS GLANDULIFERA FLOWER; MERCURIUS SOLUBILIS; NADIDE; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER; LACTIC ACID, L-; COMFREY ROOT; UBIDECARENONE; ACTIVATED CHARCOAL; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; PROTEUS MORGANII 2; 2; 2; 2; 2; 3; 3; 3; 3; 3; 4; 4; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g N 20181231 43742-0378_ec1d36b1-b364-4656-9e0a-3da3ba43cb16 43742-0378 HUMAN OTC DRUG Influenza Plus Eucalyptus Globulus, Ipecacuanha, Aconitum Napellus, Influenzinum, Respiratory Syncytial Virus Nosode (RSV), Belladonna, Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Kreosotum, Veratrum Viride LIQUID ORAL 20140903 20190311 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EUCALYPTUS GLOBULUS LEAF; IPECAC; ACONITUM NAPELLUS; INFLUENZA A VIRUS; INFLUENZA B VIRUS; RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN); ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; WOOD CREOSOTE; VERATRUM VIRIDE ROOT 2; 3; 3; 8; 8; 8; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0379_1600cc36-9a13-42d5-897a-5bf331911cae 43742-0379 HUMAN OTC DRUG Lymph Spleen Combo Castanea Vesca, Juniperus Communis, Phytolacca Decandra, Quercus Glandium Spiritus, Myosotis Arvensis, Natrum Sulphuricum, Ceanothus Americanus, Helianthus Annuus, Natrum Muriaticum, Lymph (Suis), Spleen (Suis), Thymus (Suis), Chininum Arsenicosum, Adenosinum Triphosphoricum Dinatrum, Coenzyme Q10, Ferrum Metallicum, Succinum, Apis Mellifica LIQUID ORAL 20140218 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CASTANEA SATIVA LEAF; JUNIPERUS COMMUNIS WHOLE; PHYTOLACCA AMERICANA ROOT; QUERCUS ROBUR NUT; MYOSOTIS ARVENSIS; SODIUM SULFATE; CEANOTHUS AMERICANUS LEAF; HELIANTHUS ANNUUS FLOWERING TOP; SODIUM CHLORIDE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; QUININE ARSENATE; ADENOSINE TRIPHOSPHATE DISODIUM; UBIDECARENONE; IRON; AMBER; APIS MELLIFERA 3; 3; 3; 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0380_e7c18c52-e63c-4e93-a735-fb43f9864abb 43742-0380 HUMAN OTC DRUG Governing Vessel Conception Vessel Meridian Formula Phenylalanine, Taurine, Nerve (Suis), Ascorbic Acid, Adenosinum Triphosphoricum Dinatrum, Brain (Suis), Sarcolacticum Acidum, Adrenocorticotrophin, Malvin, Apis Mellifica, Arsenicum Album, Baryta Carbonica, Belladonna, Calcarea Carbonica, Cicuta Virosa, Conium Maculatum, Ferrum Metallicum, Lachesis Mutus, Lycopodium Clavatum, Mercurius Solubilis, Natrum Sulphuricum, Phosphorus, Pulsatilla (Vulgaris), Sepia, Tarentula Hispana, Thuja Occidentalis, Dysentery Bacillus LIQUID ORAL 20140613 20200819 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHENYLALANINE; TAURINE; SUS SCROFA NERVE; ASCORBIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; PORK BRAIN; LACTIC ACID, L-; CORTICOTROPIN; MALVIN; APIS MELLIFERA; ARSENIC ACID; BARIUM CARBONATE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CICUTA VIROSA ROOT; CONIUM MACULATUM FLOWERING TOP; IRON; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; LYCOSA TARANTULA; THUJA OCCIDENTALIS LEAFY TWIG; SHIGELLA DYSENTERIAE 6; 6; 8; 6; 6; 6; 6; 8; 10; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0381_12905645-cda5-45b4-b125-5d25d5d677cc 43742-0381 HUMAN OTC DRUG Free Radical Alfalfa, Ascorbyl Palmitate, Cysteinum, Hordeum Vulgare, Laminaria Digitata, Manganese Gluconate, Methionine, Nasturtium Aquaticum, N,N-Dimethylglycine, Quercetin, Raphanus Sativus, Sodium Selenite, Triticum Aestivum, Co-Enzyme Q-10, Alpha-Lipoicum Acidum, Oryza Sativa, Vitamin E, Zinc Picolinate, Cobaltum Metallicum, Ferrum Metallicum, Glutathione, Magnesium Fluoratum, Selenium Metallicum, Zincum Metallicum, Alpha Ketoglutaricum Acidum, Glyoxal Trimer Dihydrate LIQUID ORAL 20140709 20210222 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALFALFA; ASCORBYL PALMITATE; CYSTEINE; BARLEY; LAMINARIA DIGITATA; MANGANESE GLUCONATE; METHIONINE; NASTURTIUM OFFICINALE; N,N-DIMETHYLGLYCINE; QUERCETIN; RAPHANUS SATIVUS; SODIUM SELENITE; WHEAT; UBIDECARENONE; .ALPHA.-LIPOIC ACID; ORYZA SATIVA WHOLE; .ALPHA.-TOCOPHEROL; ZINC PICOLINATE; COBALT; IRON; GLUTATHIONE; MAGNESIUM FLUORIDE; SELENIUM; ZINC; .ALPHA.-KETOGLUTARIC ACID; GLYOXAL TRIMER DIHYDRATE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0382_bbc8d0cb-3de4-4277-9275-b2e6dd6d5c19 43742-0382 HUMAN OTC DRUG Healing Support Betula Cortex, Caltha Palustris, Galium Aparine, Sedum Acre, Thuja Occidentalis, Urtica urens, Clematis Erecta, Hedera Helix, Juniperus Communis, Quillaja Saponaria, Sempervivum Tectorum, Echinacea, LIQUID ORAL 20131104 20181210 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETULA PENDULA BARK; CALTHA PALUSTRIS; GALIUM APARINE; SEDUM ACRE; THUJA OCCIDENTALIS LEAF; URTICA URENS; CLEMATIS RECTA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; JUNIPERUS COMMUNIS WHOLE; QUILLAJA SAPONARIA BARK; SEMPERVIVUM TECTORUM LEAF; ECHINACEA, UNSPECIFIED; NITRIC ACID; SILVER; CALCIUM FLUORIDE; PHOSPHORUS; APIS MELLIFERA; RANCID BEEF; ONONIS SPINOSA ROOT 2; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 12; 12; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0393_3e9e9d50-644d-4985-98ef-112a2f23d1f0 43742-0393 HUMAN OTC DRUG Immune Support Echinacea (Angustifolia), Aconitum Napellus, Arnica Montana, Baptisia Tinctoria, Rhus Tox, Sanguinaria Canadensis, Aristolochia Clematitis, Bryonia (Alba), Eupatorium Perfoliatum, Euphorbium Officinarum, Gelsemium Sempervirens, Mercurius Corrosivus, Phytolacca Decandra, Argentum Nitricum, Arsenicum Album, Phosphorus, Pulsatilla (Vulgaris), Sulphur, Thuja Occidentalis, Hepar Sulphuris Calcareum, Lachesis Mutus, Zincum Metallicum, Astragalus Menziesii, Belladonna, Influenzinum, Spleen (Suis), Thymus (Suis), LIQUID ORAL 20140428 20190930 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; ACONITUM NAPELLUS; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; ARISTOLOCHIA CLEMATITIS ROOT; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; MERCURIC CHLORIDE; PHYTOLACCA AMERICANA ROOT; SILVER NITRATE; ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; CALCIUM SULFIDE; LACHESIS MUTA VENOM; ZINC; ASTRAGALUS NUTTALLII LEAF; ATROPA BELLADONNA WHOLE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; VISCUM ALBUM FRUITING TOP; CORTISONE ACETATE; RANCID BEEF 2; 3; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12; 13; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0394_732d1217-3638-4b6f-9db1-5ba26e86f0a3 43742-0394 HUMAN OTC DRUG PHLORIDZIN Phloridzinum LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHLORIZIN 6 [hp_X]/mL N 20181231 43742-0395_dfe06236-7031-4251-ad2f-2240a0284257 43742-0395 HUMAN OTC DRUG VITAMIN A MIX NOT APPLICABLE LIQUID ORAL 20141007 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HISTAMINE DIHYDROCHLORIDE; OCTOPAMINE; TYRAMINE; ASPARAGINE; POTASSIUM IODIDE; SODIUM CHLORIDE; BETA CAROTENE; LACTIC ACID, L-; VITAMIN A PALMITATE; CORTICOTROPIN; ENTEROBACTER CLOACAE; PROTEUS VULGARIS 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0396_0984e1d3-a05b-4529-8463-ab75bc9c6953 43742-0396 HUMAN OTC DRUG Bacteria Plus ATP, Malic acid, Natrum oxalaceticum, Oroticum acidum, Roboflavinum, Apiolum, Cinnamic acid, Streptococcus viridans, Colibacillinum cum naturm muriaticum, Echinacea, LIQUID ORAL 20140207 20190311 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE; MALIC ACID; SODIUM DIETHYL OXALACETATE; OROTIC ACID MONOHYDRATE; RIBOFLAVIN; APIOLE (PARSLEY); CINNAMIC ACID; STREPTOCOCCUS VIRIDANS GROUP; ESCHERICHIA COLI; ECHINACEA ANGUSTIFOLIA; HELICOBACTER PYLORI; MYCOPLASMA PNEUMONIAE; PROTEUS MIRABILIS; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; STREPTOCOCCUS PNEUMONIAE; YERSINIA ENTEROCOLITICA; STREPTOCOCCUS AGALACTIAE; LEGIONELLA PNEUMOPHILA; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS MUTANS; LISTERIA MONOCYTOGENES; SHIGELLA DYSENTERIAE; SHIGELLA SONNEI; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS PYOGENES; STREPTOCOCCUS UBERIS; PROTEUS MORGANII; STREPTOCOCCUS EQUINUS 6; 6; 6; 6; 6; 6; 6; 12; 15; 15; 15; 15; 15; 15; 15; 15; 17; 9; 11; 13; 13; 14; 15; 15; 15; 15; 15; 30; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0397_0ee494e9-6916-45c7-8aaf-77ba35409460 43742-0397 HUMAN OTC DRUG Virus Plus Influenzinum, Adenoviren Nosode, Herpes Simplex 1, Herpes Simplex 2, Cytomegalovirus Nosode, Epstein-Barr Virus Nosode, Hepatitis B Nosode LIQUID ORAL 20140418 20190924 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. INFLUENZA A VIRUS; INFLUENZA B VIRUS; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578; HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4; HEPATITIS B VIRUS 12; 12; 15; 15; 15; 15; 18; 18; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0398_71c33730-1bf9-4f56-8aba-9d7847802bfa 43742-0398 HUMAN OTC DRUG Glucoreg Ascorbic Acid, Pyridoxinum Hydrochloricum, Riboflavinum, Sarcolacticum Acidum, Thiaminum Hydrochloricum, Acetaldehyde, DHEA (Dehydroepiandrosterone), Insulinum, Phloridzinum, alpha-Lipoicum Acidum, Adenosinum Triphosphoricum Disodium, Citricum Acidum, Coenzyme A, Fumaricum Acidum, Glyoxal Trimer Dihydrate, Nadidum, Hepar Suis, Pancreas Suis, Glucagon, Baryta Oxalica, Alloxanum, Berberis Vulgaris, Carcinosin, Lycopodium Clavatum, Momordica Balsamina, Phosphoricum Acidum, Phosphorus, Syzygium Jambolanum, LIQUID ORAL 20140423 20191126 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASCORBIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; LACTIC ACID, L-; THIAMINE HYDROCHLORIDE; ACETALDEHYDE; PRASTERONE; INSULIN PORK; PHLORIZIN; THIOCTIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; ANHYDROUS CITRIC ACID; COENZYME A; FUMARIC ACID; GLYOXAL; NADIDE; PORK LIVER; SUS SCROFA PANCREAS; GLUCAGON; BARIUM OXALATE; ALLOXAN; BERBERIS VULGARIS ROOT BARK; HUMAN BREAST TUMOR CELL; LYCOPODIUM CLAVATUM SPORE; MOMORDICA BALSAMINA IMMATURE FRUIT; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; GYMNEMA SYLVESTRE LEAF; FENUGREEK SEED 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0400_5a0514c1-ce83-47e5-9764-15932a20f350 43742-0400 HUMAN OTC DRUG Pertussis Aconitum napellus, Antimonium tartaricum, Belladonna, Bryonia (Alba), Hyoscyamus niger, Ipecacuanha, Lobelia inflata, Sticta pulmonaria, Phosphorus, LIQUID ORAL 20140612 20200728 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; HYOSCYAMUS NIGER; IPECAC; LOBELIA INFLATA; LOBARIA PULMONARIA; PHOSPHORUS; WOOD CREOSOTE; SILICON DIOXIDE; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; CLOSTRIDIUM TETANI 4; 4; 4; 4; 4; 4; 4; 4; 5; 6; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0401_530228ec-31f7-4226-aa4a-2ca131cf39c7 43742-0401 HUMAN OTC DRUG Bio Cytotox Phase Colchicum Autumnale, Conium Maculatum, Hydrastis Canadensis, Vaccinium Myrtillus, Podophyllum Peltatum, Ascorbic Acid, Galium Aparine, Nicotinamidum, Pyridoxinum Hydrochloricum, Riboflavinum, Sarcolacticum Acidum, Thiaminum Hydrochloricum, Norepinephrine, Alpha-lipoicum Acidum, Natrum Oxalaceticum, Sulphur, Acetylsalicylicum Acidum, Anthraquinone, Adenosinum Triphosphoricum Dinatrum, Coenzyme A, Co-Enzyme Q-10, Histaminum Hydrochloricum, Magnesium Gluconate, Nadidum, Naphthoquinone, Manganum Phosphoricum, LIQUID ORAL 20140911 20200722 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; BILBERRY; PODOPHYLLUM; ASCORBIC ACID; GALIUM APARINE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; LACTIC ACID, L-; THIAMINE HYDROCHLORIDE; NOREPINEPHRINE; .ALPHA.-LIPOIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; ASPIRIN; ANTHRAQUINONE; ADENOSINE TRIPHOSPHATE DISODIUM; COENZYME A; UBIDECARENONE; HISTAMINE DIHYDROCHLORIDE; MAGNESIUM GLUCONATE; NADIDE; 1,4-NAPHTHOQUINONE; MANGANESE PHOSPHATE, DIBASIC; HYDROQUINONE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 4; 4; 4; 5; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0402_7e5481fa-cc6e-4580-a84d-f3339e7f0da7 43742-0402 HUMAN OTC DRUG Bio Co-Enzyme Phase Beta Vulgaris, Ascorbic Acid, Cysteinum, Natrum Oxalaceticum, Nicotinamidum, Pulsatilla (Vulgaris), Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Adrenalinum, Alpha-Ketoglutaricum Acidum, Alpha-Lipoicum Acidum, Cerium Oxalicum, CIS-Aconitic Acid, Citricum Acidum, Coenzyme A, Fumaricum Acidum, Magnesium Orotate, Malic Acid, Nadidum, Natrum Pyruvicum, Succinicum Acidum, Adenosinum Triphosphoricum Dinatrum, Hepar Sulphuris Calcareum, Sulphur, Manganum Phosphoricum, Baryta Oxalsuccinicum LIQUID ORAL 20140331 20201116 UNAPPROVED HOMEOPATHIC Deseret Biolgicals, Inc. BETA VULGARIS; ASCORBIC ACID; CYSTEINE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; EPINEPHRINE; OXOGLURIC ACID; THIOCTIC ACID; CEROUS OXALATE NONAHYDRATE; ACONITIC ACID, (Z)-; ANHYDROUS CITRIC ACID; COENZYME A; FUMARIC ACID; MAGNESIUM OROTATE; MALIC ACID; NADIDE; SODIUM PYRUVATE; SUCCINIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; CALCIUM SULFIDE; SULFUR; MANGANESE PHOSPHATE, DIBASIC; BARIUM OXALOSUCCINATE; PROTEUS MORGANII 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 16; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 43742-0403_73a1aa0f-b40b-4604-bf11-b8b076fa02ab 43742-0403 HUMAN OTC DRUG Dopamine Dopamine Hydrochloride LIQUID ORAL 20140314 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DOPAMINE HYDROCHLORIDE 6 [hp_X]/mL N 20181231 43742-0404_8fdc4ec4-fcf8-43cb-a0d1-f158b5fdc3ca 43742-0404 HUMAN OTC DRUG Bio Galium Phase Betula (Pendula), cortex, Caltha palustris, Clematis erecta, Galium aparine, Hedera helix, Juniperus comminis, Sedum acre, Sempervivum tectorum, Thuja occidentalis, LIQUID ORAL 20140520 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETULA PENDULA BARK; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; GALIUM APARINE; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; CORTISONE ACETATE; SILVER; CALCIUM FLUORIDE; PHOSPHORUS; GOLD; APIS MELLIFERA; ONONIS SPINOSA WHOLE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 5; 6; 6; 8; 8; 8; 10; 12; 5; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0405_d8bf7d60-14eb-4281-9361-1b5e73450afb 43742-0405 HUMAN OTC DRUG Bio Glyoxal Phase Aconitum Napellus, Arnica Montana, Baptisia Tinctoria, Rhus Tox, Echinacea (Angustifolia), Sanguinaria Canadensis, Bryonia (Alba), Eupatorium Perfoliatum, LIQUID ORAL 20140401 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; TOXICODENDRON PUBESCENS LEAF; ECHINACEA ANGUSTIFOLIA; SANGUINARIA CANADENSIS ROOT; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; CORTISONE ACETATE; DOPAMINE HYDROCHLORIDE; SILVER NITRATE; ARSENIC TRIOXIDE; MERCURIC CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; GLYOXAL TRIMER DIHYDRATE; CALCIUM SULFIDE; LACHESIS MUTA VENOM; PYRUVALDEHYDE; ZINC 3; 4; 4; 4; 5; 5; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0406_80cb4f46-2c34-441a-992e-4048d490532c 43742-0406 HUMAN OTC DRUG Bio Lymph Phase Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla, Ascorbic Acid, Quercetin, Calcarea Phosphorica, Ferrum Iodatum, Thyroidinum (Suis), Gaertner Bacillus LIQUID ORAL 20140429 20210209 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS NIGRA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; ARANEUS DIADEMATUS; SARSAPARILLA; ASCORBIC ACID; QUERCETIN; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA THYROID; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 5; 5; 5; 6; 6; 6; 6; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0407_fd32045d-ee46-46f9-8c10-46a7b1c5c957 43742-0407 HUMAN OTC DRUG Bio Placenta Phase Aesculus Hippocastanum, Sarcolacticum Acidum, Secale Cornutum, Cuprum Sulphuricum, Melilotus Officinalis, Placenta Totalis Suis, Solanum Nigrum, Strophanthus Hispidus, DHEA (Dehydroepiandrosterone), Quercetin, Rutin, Natrum Pyruvicum, Vein (Suis), Artery (Suis), Funiculus Umbilicalis Suis, Tabacum, Vipera Berus, Baryta Carbonica, Plumbum Iodatum, Astragalus Exscapus, Proteus (Vulgaris) LIQUID ORAL 20140522 20200811 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HORSE CHESTNUT; LACTIC ACID, L-; CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC SULFATE; MELILOTUS OFFICINALIS TOP; SUS SCROFA PLACENTA; SOLANUM NIGRUM WHOLE; STROPHANTHUS HISPIDUS SEED; PRASTERONE; QUERCETIN; RUTIN; SODIUM PYRUVATE; SUS SCROFA VEIN; SUS SCROFA ARTERY; SUS SCROFA UMBILICAL CORD; TOBACCO LEAF; VIPERA BERUS VENOM; BARIUM CARBONATE; LEAD IODIDE; ASTRAGALUS EXSCAPUS WHOLE FLOWERING/FRUITING; PROTEUS VULGARIS 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 10; 10; 10; 10; 13; 18; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0408_230a1fed-f10e-41e6-909a-de771019ed3c 43742-0408 HUMAN OTC DRUG Bio Thalamus Phase Adenosinum Cyclophosphoricum, Apiolum, L-DOPA, Melatonin, Pineal (Suis), Thalamus Opticus (Suis), Viscum Album, LIQUID ORAL 20140612 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE CYCLIC PHOSPHATE; APIOLE (PARSLEY); LEVODOPA; MELATONIN; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; VISCUM ALBUM FRUITING TOP 6; 6; 6; 6; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0409_af28fca7-352e-47a9-8b13-a6b10b77f6b5 43742-0409 HUMAN OTC DRUG Bio Tonsilla Phase Conium Maculatum, Dulcamara, Echinacea (Angustifolia), Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid, Coccus Cacti, Galium Aparine, LIQUID ORAL 20140501 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA ANGUSTIFOLIA; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; PULSATILLA VULGARIS; LACTIC ACID, L-; ACETYLCHOLINE CHLORIDE; YEAST MANNAN; SUS SCROFA LYMPH; SULFUR; TRIBASIC CALCIUM PHOSPHATE; FERRUM PHOSPHORICUM; SUS SCROFA UMBILICAL CORD; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA BONE MARROW; SUS SCROFA SPLEEN; CORTISONE ACETATE; SUS SCROFA ADRENAL GLAND; MERCURIUS SOLUBILIS; SUS SCROFA THYROID; BARIUM CARBONATE; SUS SCROFA TONSIL 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 10; 10; 10; 10; 10; 10; 10; 13; 13; 13; 13; 28; 28 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0410_a17f5189-6438-43b7-b40a-82238561cee6 43742-0410 HUMAN OTC DRUG Bio Viscum Phase Viscum Album, Serotonin (Hydrochloride), Tryptophan, Adenosinum Cyclophosphoricum, Mercurius Iodatus Flavus LIQUID ORAL 20140715 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. VISCUM ALBUM FRUITING TOP; SEROTONIN HYDROCHLORIDE; TRYPTOPHAN; ADENOSINE CYCLIC PHOSPHATE; MERCUROUS IODIDE 3; 6; 6; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0411_7c3200f7-ca7d-4d8c-851a-0951dacd0293 43742-0411 HUMAN OTC DRUG BIO MOOD PHASE Cortisone Aceticum, Adrenalinum, Chininum Arsenicosum, Helonias Dioica, Hypericum Perforatum, Kali Phosphoricum, Nux Vomica, Selenium, Aurum Metallicum Bacillus 7 LIQUID ORAL 20141010 20200916 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CORTISONE ACETATE; EPINEPHRINE; QUININE ARSENATE; CHAMAELIRIUM LUTEUM ROOT; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SELENIUM; GOLD; ENTEROBACTER CLOACAE 6; 6; 10; 10; 10; 10; 10; 10; 10; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0412_b7cb3680-d5fa-4053-82c5-9164a37cf7b1 43742-0412 HUMAN OTC DRUG Chronagesic Dulcamara, Arnica Montana, Rhus Tox, Sanguinaria Canadensis, Cartilago Suis, Coenzyme A, Funiculus Umbilicalis Suis, Nadidum, Natrum Oxalaceticum, Placenta Totalis Suis, Sulphur, Chondroitin Sulphate Sodium (Bovine), Methylsulfonylmethane (MSM), Apiolum, Cinnamic Acid, Menadione, Piperine, Alpha-Lipoicum Acidum, Silicea, Symphytum Officinale, Human Growth Hormone, Gaertner Bacillus, Sycotic Co Bacillus LIQUID ORAL 20140401 20200916 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SOLANUM DULCAMARA TOP; ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SUS SCROFA CARTILAGE; COENZYME A; SUS SCROFA UMBILICAL CORD; NADIDE; SODIUM DIETHYL OXALACETATE; SUS SCROFA PLACENTA; SULFUR; CHONDROITIN SULFATE SODIUM (BOVINE); DIMETHYL SULFONE; APIOLE (PARSLEY); CINNAMIC ACID; MENADIONE; PIPERINE; .ALPHA.-LIPOIC ACID; SILICON DIOXIDE; COMFREY ROOT; SOMATROPIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; ENTEROCOCCUS FAECALIS 2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0413_1b190116-7ccf-4e9f-bd89-4d28a4a706e7 43742-0413 HUMAN OTC DRUG Sinusitis Pulsatilla (Vulgaris), Plantago Major, Euphorbium Officinarum, Luffa Operculata, Mercurius Iodatus Ruber, Mucosa Nasalis Suis, Argentum Nitricum, Hepar Sulphuris Calcareum, Calcarea Carbonica, Natrum Muriaticum, Sinusitisinum LIQUID ORAL 20140416 20210809 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PULSATILLA VULGARIS; PLANTAGO MAJOR; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SUS SCROFA NASAL MUCOSA; SILVER NITRATE; CALCIUM SULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; SINUSITISINUM 2; 3; 4; 6; 8; 8; 10; 10; 12; 12; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0414_cf66f2b7-2338-477f-888b-dae5fdb7c55f 43742-0414 HUMAN OTC DRUG Focus RXS Alpha-Ketoglutaricum Acidum, ATP (Adenosine Triphosphate Disodium), Formicum Acidum, Malic Acid, Sarcolacticum Acidum, Dulcamara, Hyoscyamus Niger, Phosphorus, Sabina, Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, , GABA (Gamma-Aminobutryic Acid), Norepinephrine, Octopamine, Phenylethylamine, Serotonin (Hydrochloride), Taurine, Tryamine, Adenosinum Cyclophosphoricum, Brain (Suis), Brain Stem (Suis), Cerebrum (Suis), Diencephalon (Suis), Pineal Gland (Suis), Thalamus Opticus (Suis) LIQUID ORAL 20140403 20201208 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; FORMIC ACID; MALIC ACID; LACTIC ACID, L-; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; PHOSPHORUS; JUNIPERUS SABINA LEAFY TWIG; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; DOPAMINE; .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; OCTOPAMINE; PHENETHYLAMINE; SEROTONIN HYDROCHLORIDE; TAURINE; TYRAMINE; ADENOSINE CYCLIC PHOSPHATE; PORK BRAIN; SUS SCROFA BRAINSTEM; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; SILICON DIOXIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; SHIGELLA DYSENTERIAE; STRYCHNOS NUX-VOMICA SEED; LYCOSA TARANTULA; VALERIAN; VERATRUM ALBUM ROOT 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0415_699c7c6c-5651-4e5a-a1fe-ba0343ca3f1e 43742-0415 HUMAN OTC DRUG Stomach Spleen Meridian Formula Hydrocortisone (Cortisol), Histaminum Hydrochloricum, Adenosinum Triphosphoricum Dinatrum, Ascorbic Acid, Pyridoxinum Hydrochloricum, Riboflavinum, Sarcolacticum Acidum, Spleen (suis), Stomach (suis), Cortisone Aceticum, Arsenicum Album, Calcarea Carbonica, Carduus Marianus, Ceanothus Americanus, Cinchona Officinalis, Digitalis Purpurea, Dysentery Bacillus, Ignatia Amara, Kali Bichromicum, Lycopodium Clavatum, Phosphorus, Plumbum Metallicum, Pulsatilla (Vulgaris), Ranunculus Bulbosus, Veratrum Viride LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HYDROCORTISONE; HISTAMINE DIHYDROCHLORIDE; ADENOSINE TRIPHOSPHATE; ASCORBIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; LACTIC ACID, L-; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; CORTISONE ACETATE; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MILK THISTLE; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; DIGITALIS; SHIGELLA DYSENTERIAE; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; LEAD; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; VERATRUM VIRIDE ROOT 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0418_ce1b5ad2-ab5c-48bd-88f7-d563662c08a6 43742-0418 HUMAN OTC DRUG FNG Berberis Vulgaris, Cochlearia Armoracia, Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Tabebuia Impetiginosa, Propolis, Formalinum, Glandula Suprarenalis Suis, Thymus (Suis), Ferrum Metallicum, Iridium Metallicum, Lycopodium Clavatum, Phosphoricum Acidum, Pulsatilla (Vulgaris), Selenium Metallicum, Zincum Metallicum, ATP (Adenosine Triphosphate Disodium), Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Pullularia Pullulans LIQUID ORAL 20140327 20200528 UNAPPROVED HOMEOPATHIC Deseret Biologicals BERBERIS VULGARIS ROOT BARK; HORSERADISH; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; FORMALDEHYDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; IRON; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; ANEMONE PULSATILLA WHOLE; SELENIUM; ZINC; ADENOSINE TRIPHOSPHATE DISODIUM; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; METHYLCOBALAMIN; LACTIC ACID, L-; STACHYBOTRYS CHARTARUM; ESCHERICHIA COLI 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0419_46f1f35f-1b03-4cf2-88f8-489a90751907 43742-0419 HUMAN OTC DRUG LYME PLUS Arnica Montana, Calendula Officinalis, Echinacea, Hydrastis Canadensis, Myrrha, Phytolacca Decandra, Taraxacum Officinale, Trifolium Pratense, Trigonella Foenum Graecum, Urtica Dioica, Propolis, Adrenalinum, Gunpowder, Thymus (Suis), Thyroidinum (Suis), Arsenicum Album, Cocculus Indicus, Iridium Metallicum, Lycopodium Clavatum, Phosphorus, Thus Toxicodendron, Borrelia Burgdorferi Nosode, Encephalitis Nosode, Ledum Palustre, Meningococcus Nosode, Hepatitis B Nosode LIQUID ORAL 20141104 20190104 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; GOLDENSEAL; MYRRH; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; TRIGONELLA FOENUM-GRAECUM WHOLE; URTICA DIOICA; PROPOLIS WAX; EPINEPHRINE; ACTIVATED CHARCOAL; SULFUR; POTASSIUM NITRATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; ARSENIC TRIOXIDE; ANAMIRTA COCCULUS SEED; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; BORRELIA BURGDORFERI; JAPANESE ENCEPHALITIS VIRUS; LEDUM PALUSTRE TWIG; NEISSERIA MENINGITIDIS; HEPATITIS B VIRUS 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 15; 15; 30; 30; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0420_a17aba36-d7ae-41fe-a28f-dec12fba2a25 43742-0420 HUMAN OTC DRUG Energize RXS Sarcolacticum Acidum, Viscum Album, Iodium, Colchicum Autumnale, Conium Maculatum, Fucus Vesiculosus, Galium Aparine, Natrum Oxalaceticum, Thyroidinum (Suis), DHEA (Dehydroepiandrosterone), Phenyl Isothiocyanate, Tri-Iodothyronine, Tyramine, Alpha-Ketoglutaricum Acidum, Adenosinum Triphosphoricum Dinatrum, Fumaricum Acidum, Malic Acid, Funiculus Umbilicalis Suis, Hepar Suis, Medulla Ossis Suis, Pineal Gland (Suis), Spleen (Suis), Thymus (Suis), Calcarea Fluorica, Pulsatilla (Vulgaris) LIQUID ORAL 20140214 20201118 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LACTIC ACID, L-; VISCUM ALBUM FRUITING TOP; IODINE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; FUCUS VESICULOSUS; GALIUM APARINE; SODIUM DIETHYL OXALACETATE; THYROID, PORCINE; PRASTERONE; PHENYL ISOTHIOCYANATE; LIOTHYRONINE; TYRAMINE; .ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; FUMARIC ACID; MALIC ACID; SUS SCROFA UMBILICAL CORD; PORK LIVER; SUS SCROFA BONE MARROW; SUS SCROFA PINEAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; CALCIUM FLUORIDE; ANEMONE PULSATILLA; SPONGIA OFFICINALIS SKELETON, ROASTED; CORTISONE ACETATE; MERCURIC CHLORIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; ESCHERICHIA COLI 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 8; 8; 12; 12; 12; 30; 60; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0421_3663232e-3e20-42b4-8862-aa8fe9f96a25 43742-0421 HUMAN OTC DRUG Aspartame MSG Detox Chelidonium Majus, Phytolacca Decandra, Arnica Montana, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum, Bisphenol A (BPA), Dextrose, Maltodextrin, Sucralose, Aspartic Acid, Diketopiperazine, Dopamine Hydrochloride, Formalinum, Methyl Alcohol, Monosodium Glutamate, Phenylalanine LIQUID ORAL 20140613 20210806 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHELIDONIUM MAJUS; PHYTOLACCA AMERICANA ROOT; ARNICA MONTANA; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; BISPHENOL A; DEXTROSE; MALTODEXTRIN; SUCRALOSE; ASPARTIC ACID; 2,5-PIPERAZINEDIONE; DOPAMINE HYDROCHLORIDE; FORMALDEHYDE; FORMIC ACID; METHYL ALCOHOL; MONOSODIUM GLUTAMATE; PHENYLALANINE 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0422_d46bd4f8-4115-444a-8e26-c1138bc5a79c 43742-0422 HUMAN OTC DRUG MANNAN Mannan LIQUID ORAL 20141013 20200512 UNAPPROVED HOMEOPATHIC Deseret Biolgicals, Inc. YEAST MANNAN 6 [hp_X]/mL N 20181231 43742-0423_854939aa-c9bb-4044-bb31-debecf36e240 43742-0423 HUMAN OTC DRUG EBV/CFS Plus Baptisia tinctoria, Condurango, Echinacea (angustifolia), Hydrastis canadensis, Nasturtium aquaticum, Ligusticum porteri, Nasturtium aquaticum, Phytolacca decandra, Tabebuia impetiginosa, Astragalus menziesii, Propolis, Glandula suprarenalis suis, Thymus (suis), Aranea diadema, Gelsemium sempervirens, Ipecacuanha, Lycopodium clavatum, Mercurius solubilis, Muriaticum acidum, Nitricum acidum, Rhus tox, Selenium metallicum, Silicea, Epstein-barr virus nosode LIQUID ORAL 20140325 20210223 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BAPTISIA TINCTORIA ROOT; MARSDENIA CONDURANGO BARK; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; TABEBUIA IMPETIGINOSA BARK; ASTRAGALUS NUTTALLII LEAF; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; ARANEUS DIADEMATUS; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; HYDROCHLORIC ACID; NITRIC ACID; TOXICODENDRON PUBESCENS LEAF; SELENIUM; SILICON DIOXIDE; HUMAN HERPESVIRUS 4 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0434_6f613e4a-4988-4fb4-9ad4-80ff8696ee2f 43742-0434 HUMAN OTC DRUG Rheumatoid Arthritis Nosode ATP (Adenosine Triphosphate Disodium), Malic Acid, Natrum Oxalaceticum, Riboflavinum, Apiolum, Cinnamic Acid, DHEA (Dehydroepiandrosterone), Streptococcus viridans LIQUID ORAL 20140711 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; MALIC ACID; SODIUM DIETHYL OXALACETATE; OROTIC ACID MONOHYDRATE; RIBOFLAVIN; APIOLE (PARSLEY); CINNAMIC ACID; PRASTERONE; STREPTOCOCCUS VIRIDANS GROUP; BORRELIA BURGDORFERI; BRUCELLA ABORTUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAMPYLOBACTER JEJUNI; CHLAMYDIA TRACHOMATIS; KLEBSIELLA PNEUMONIAE; MYCOPLASMA PNEUMONIAE; YERSINIA ENTEROCOLITICA; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS AGALACTIAE; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS MUTANS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SHIGELLA SONNEI; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS PYOGENES; STREPTOCOCCUS UBERIS; PROTEUS MORGANII; STREPTOCOCCUS EQUINUS 6; 6; 6; 6; 6; 6; 6; 6; 12; 15; 15; 15; 15; 15; 15; 15; 17; 17; 9; 13; 13; 14; 15; 15; 15; 15; 15; 30; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0435_aaf7db14-7fbd-428f-b7af-12d0537e3d6b 43742-0435 HUMAN OTC DRUG B COMPLEX MIX Magnesium Orotate, Beta Vulgaris, Ascorbic Acid, Citricum Acidum, Cysteinum, Pulsatilla (Vulgaris), Adenine, Amygdalin, Adenosinum Triphosphoricum Dinatrum, Cholinum, Cyanocobalamin, Folic Acid, Inositol, Niacin, P-Aminobenzoic Acid, Pangamic Acid, Pantothenic Acid, Pyridoxinum Hydrochloricum, Riboflavinum, Sulphur, Thiaminum Hydrochloricum, Natrum Oxalaceticum, Oroticum Acidum, Manganum Phosphoricum, Mutabile Bacillus (Bach), Morgan Bacillus (Pure) LIQUID ORAL 20141008 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MAGNESIUM OROTATE; BETA VULGARIS; ASCORBIC ACID; ANHYDROUS CITRIC ACID; CYSTEINE; PULSATILLA VULGARIS; ADENINE; AMYGDALIN; ADENOSINE TRIPHOSPHATE DISODIUM; CHOLINE HYDROXIDE; CYANOCOBALAMIN; FOLIC ACID; INOSITOL; NIACIN; AMINOBENZOIC ACID; PANGAMIC ACID; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SULFUR; THIAMINE HYDROCHLORIDE; SODIUM DIETHYL OXALACETATE; OROTIC ACID MONOHYDRATE; MANGANESE PHOSPHATE, DIBASIC; ESCHERICHIA COLI; PROTEUS MORGANII 12; 2; 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 8; 10; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0436_c626b374-4885-4393-befb-96cf6b2a2288 43742-0436 HUMAN OTC DRUG Peptostrep Remedy Peptostreptococcus anaerobius, LIQUID ORAL 20140621 20200928 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PEPTOSTREPTOCOCCUS ANAEROBIUS 19 [hp_X]/mL N 20181231 43742-0437_60667616-46b5-4abd-bb6c-b1719f96644e 43742-0437 HUMAN PRESCRIPTION DRUG Bio Psorinum Phase Oleander, Cicuta virosa, Sulphur, Thuja occidentalis, Hydrocortisone (cortisol), Vaccinium myrtillus, Bufo rana, Psorinum, Aconitum napellus, Bryonia (alba), LIQUID ORAL 20140304 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. NERIUM OLEANDER LEAF; CICUTA VIROSA ROOT; SULFUR; THUJA OCCIDENTALIS LEAF; HYDROCORTISONE; BILBERRY; BUFO BUFO CUTANEOUS GLAND; SCABIES LESION LYSATE (HUMAN); ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CALCIUM SULFATE ANHYDROUS; HUMAN BREAST TUMOR CELL; ESCHERICHIA COLI; CITRULLUS COLOCYNTHIS FRUIT PULP; GONORRHEAL URETHRAL SECRETION HUMAN; SODIUM CHLORIDE; CLAVICEPS PURPUREA SCLEROTIUM; TREPONEMIC SKIN CANKER HUMAN; ENTEROCOCCUS FAECALIS 4; 5; 6; 6; 6; 8; 10; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 43742-0448_afcd90c5-e971-48ca-98fe-c8523288bbee 43742-0448 HUMAN OTC DRUG PEMF Optimizer Aqua sulis, Argentum metallicum, Aurum metallicum, Cuprum metallicum, Lapis albus, Manganum metallicum Vanadium Metallicum Viscum album, Zincum metallicum, LIQUID ORAL 20140623 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. WATER; SILVER; GOLD; COPPER; CALCIUM HEXAFLUOROSILICATE; MANGANESE; VANADIUM; VISCUM ALBUM FRUITING TOP; ZINC 30; 1; 1; 1; 1; 1; 1; 1; 1 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 43742-0449_5f6f1402-60e2-4ec8-bf05-8c55751146ca 43742-0449 HUMAN OTC DRUG Bronchial Cough Coccus cacti, Drosera (Rotundifolia), Scilla maritima, Stica pulmonaria, Arsenicum iodatum, Causticum, Cuprum aceticum, Carbo vegetabilis, Kali carbonicum, Lachesis mutus, LIQUID ORAL 20140501 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PROTORTONIA CACTI; DROSERA ROTUNDIFOLIA; DRIMIA MARITIMA BULB; LOBARIA PULMONARIA; ARSENIC TRIIODIDE; CAUSTICUM; CUPRIC ACETATE; ACTIVATED CHARCOAL; POTASSIUM CARBONATE; LACHESIS MUTA VENOM 4; 4; 4; 4; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0452_a3e8eefd-f532-49b5-9f47-74578e49ee1c 43742-0452 HUMAN OTC DRUG Breathe RxS Aconitum Napellus, Argentum Nitricum, Arsenicum Album, Natrum Muriaticum, Rhus Tox, Sulphur, Adenosinum Cyclophosphoricum, Coenzyme A, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Lung (Suis), Mucosa Nasalis Suis, Sarcolacticum Acidum, Acetylcholine Chloride, Coumarinum, Malvin, Dysentery Bacillus, Morgan Bacillus (Pure) LIQUID ORAL 20140311 20210203 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF; SULFUR; ADENOSINE CYCLIC PHOSPHATE; COENZYME A; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; LACTIC ACID, L-; ACETYLCHOLINE CHLORIDE; COUMARIN; MALVIN; SHIGELLA DYSENTERIAE; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 6; 6; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0453_e70e3c4b-36c7-4972-84f3-487cf6480079 43742-0453 HUMAN OTC DRUG EMF Protect and Balance Alfalfa, Laminaria Digitata, Symphytum Officinale, Ascorbic Acid, Melatonin, Calcarea Carbonica, Cuprum Metallicum, Ferrum Metallicum, Iodium, Manganum Aceticum, Silicea, Phosphorus, Magnetis Polus Arcticus, Magnetis Polus Australis, X-Ray, Agate, Quartz, Carbon Dioxide, Aconitum Napellus, Arsenicum Album, Gaertner Bacillus (Bach), Kali Carbonicum LIQUID ORAL 20140318 20200805 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALFALFA; LAMINARIA DIGITATA; COMFREY ROOT; ASCORBIC ACID; MELATONIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COPPER; IRON; IODINE; MANGANESE ACETATE TETRAHYDRATE; SILICON DIOXIDE; PHOSPHORUS; ALCOHOL, X-RAY EXPOSED (1000 RAD); CARBON DIOXIDE; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; POTASSIUM CARBONATE 3; 3; 3; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0455_bbc7e424-8db5-405f-81a0-c89edc9a8927 43742-0455 HUMAN OTC DRUG Radiation Protect Chondrus crispus, Fucus vesiculosus, Thyroidinum (suis), Cadmium iodatum, Cadmium sulphuratum, Iodium, Uranium nitricum, Radium bromatum, LIQUID ORAL 20140325 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHONDRUS CRISPUS; FUCUS VESICULOSUS; SUS SCROFA THYROID; CADMIUM IODIDE; CADMIUM SULFIDE; IODINE; URANYL NITRATE HEXAHYDRATE; RADIUM BROMIDE; STRONTIUM CARBONATE; ALCOHOL, X-RAY EXPOSED (1000 RAD); ARNICA MONTANA 3; 3; 8; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0456_390e4c4c-52d4-4f15-850f-1393bc1a0f1a 43742-0456 HUMAN OTC DRUG Appetite Control Thyroidinum, Cortisone Aceticum, Anacardium Orentale, Antimonium Crudum, Ignatia Amara, LIQUID ORAL 20140311 20190924 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. THYROID, PORCINE; CORTISONE ACETATE; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; DELPHINIUM STAPHISAGRIA SEED; HYDROCORTISONE 12; 12; 15; 15; 15; 15; 18; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0457_41beb545-1717-4d42-9c07-c48d0ad6bd2f 43742-0457 HUMAN OTC DRUG Intestinal Distress Echinacea (Angustifolia), Colchicum Autumnale, Aloe Socotrina, Colocynthis, Mercurius Corrosivus, Nux Vomica, Arsenicum Album, Chininum Sulphuricum, Cholera Nosode, Campylobacter Jejuni, Colibacillinum Cum Natrum Muriaticum, Helicobacter Pylori, Shigella, Yersinia Enterocolitica, Clostridium Botulinum, Salmonella Typhi Nosode LIQUID ORAL 20140318 20190401 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; COLCHICUM AUTUMNALE BULB; ALOE; CITRULLUS COLOCYNTHIS FRUIT PULP; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED; ARSENIC TRIOXIDE; QUININE SULFATE; VIBRIO CHOLERAE; CAMPYLOBACTER JEJUNI; ESCHERICHIA COLI; HELICOBACTER PYLORI; SHIGELLA DYSENTERIAE; YERSINIA ENTEROCOLITICA; BOTULINUM TOXIN TYPE A; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 3; 4; 6; 6; 6; 6; 6; 12; 12; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0458_f4cc0fa8-7f59-4cd2-9d41-76d6ce02b248 43742-0458 HUMAN OTC DRUG Lymphoplus Trifolium Pratense, Lymph (Suis), Spleen (Suis), Conium Maculatum, Echinacea (Angustifolia), Lycopodium Clavatum, Myrrha, ,Phytolacca Decandra, Selenium Metallicum, Silicea LIQUID ORAL 20140324 20210323 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TRIFOLIUM PRATENSE FLOWER; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHYTOLACCA AMERICANA ROOT; SELENIUM; SILICON DIOXIDE 3; 8; 8; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0469_ce9245fd-399c-4263-a0a2-77ec42af950b 43742-0469 HUMAN OTC DRUG Prostate Petroselinum Sativum, Populus Tremulodies, Sabal Serrulata, Chimaphila Umbellata, Adenosinum Triphosphoricum Dinatrum, Equol, Kreosotum, Nadidum, Testosterone, Succinicum Acidum, Hepar Sulphuris Calcareum, Prostate Nosode, Conium Maculatum, Proteus (Mirabilis), Proteus (Vulgaris) LIQUID ORAL 20140320 20200520 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PETROSELINUM CRISPUM; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; SAW PALMETTO; CHIMAPHILA UMBELLATA; ADENOSINE TRIPHOSPHATE DISODIUM; EQUOL, (+/-)-; WOOD CREOSOTE; NADIDE; TESTOSTERONE; SUCCINIC ACID; CALCIUM SULFIDE; SUS SCROFA PROSTATE; CONIUM MACULATUM FLOWERING TOP; PROTEUS MIRABILIS; PROTEUS VULGARIS 4; 4; 4; 4; 5; 6; 6; 6; 6; 6; 8; 10; 11; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0470_dfca7ba9-e060-4bf0-b34b-470ef31d3967 43742-0470 HUMAN OTC DRUG Female Support Chamomilla, Cimicifuga Racemosa, Cinchona Officinalis, Convallaria Majalis, Crocus Sativus, Helonias Dioica LIQUID ORAL 20140319 20200924 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MATRICARIA RECUTITA; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; SAFFRON; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; MENTHA PIPERITA; SENNA LEAF; VALERIAN; VIOLA ODORATA; CHASTE TREE; LEDUM PALUSTRE TWIG; LILIUM LANCIFOLIUM WHOLE FLOWERING; DELPHINIUM STAPHISAGRIA SEED; CYCLAMEN PURPURASCENS TUBER; CINNAMON; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; NAJA NAJA VENOM 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 6; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0471_ef7471a0-3087-4114-bd5d-837ea0566e6c 43742-0471 HUMAN OTC DRUG Hormone Combination Salsolinol Hydrochloride, Cholesterinum, DHEA (Dehydroepiandrosterone), 7-Keto-DHEA (Dehydroepiandrosterone), Folliculinum, Oophorinum (Suis), Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone LIQUID ORAL 20140505 20200325 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SALSOLINOL HYDROCHLORIDE, (+/-)-; CHOLESTEROL; PRASTERONE; 7-KETO-DEHYDROEPIANDROSTERONE; ESTRONE; SUS SCROFA OVARY; PROGESTERONE; TESTOSTERONE; CORTISONE ACETATE; ALDOSTERONE; ANDROSTERONE; FOLLITROPIN 6; 6; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0472_4fa8b2d2-7496-413c-b91c-d7d274ba1cb4 43742-0472 HUMAN OTC DRUG Inflammation Eupatorium Perfoliatum, Arnica Montana, Benzoicum Acidum, Echinacea (Angustifolia), Mercurialis Perennis, Apis Mellifica, Baptisia Tinctoria, Bryonia (Alba), Colchicum Autumnale, Dulcamara, Eucalyptus Globulus, Solanum Nigrum, Rhus Tox LIQUID ORAL 20140321 20210211 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EUPATORIUM PERFOLIATUM FLOWERING TOP; ARNICA MONTANA; BENZOIC ACID; ECHINACEA ANGUSTIFOLIA; MERCURIALIS PERENNIS; APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; EUCALYPTUS GLOBULUS LEAF; SOLANUM NIGRUM WHOLE; TOXICODENDRON PUBESCENS LEAF 2; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0473_4d847601-3ab5-4f9a-b3d0-360723677032 43742-0473 HUMAN OTC DRUG Clostridium Difficile Remedy Clostridium Difficile LIQUID ORAL 20140423 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CLOSTRIDIUM DIFFICILE 15 [hp_X]/mL N 20181231 43742-0484_05f40232-d396-44b5-8cb5-4650b6f9d0e2 43742-0484 HUMAN OTC DRUG Lyme Plus Arnica Montana, Calendula Officinalis, Echinacea (Angustifolia), Hydrastis Canadensis, Myrrha, Phytolacca Decandra, Taraxacum Officinale, Trifolium Pratense, Trigonella Foenum-Graecum, Urtica Dioica, Propolis, Adrenalinum, Gunpowder, Thymus (Suis), Thyroidinum (Suis), Arsenicum Album, Cocculus Indicus, Iridium Metallicum, Lycopodium Clavatum, Phosphorus, Rhus Tox, Babesia Microti, Borrelia Burgdorferi Nosode, Ehrlichia (Canine), Encephalitis Nosode, Ledum Palustre, Meningococcus Nosode, Hepatitis B Nosode LIQUID ORAL 20140502 20210208 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; MYRRH; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; FENUGREEK SEED; URTICA DIOICA; PROPOLIS WAX; EPINEPHRINE; ACTIVATED CHARCOAL; SULFUR; POTASSIUM NITRATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; ARSENIC TRIOXIDE; ANAMIRTA COCCULUS SEED; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; BABESIA MICROTI; BORRELIA BURGDORFERI; EHRLICHIA CANIS; JAPANESE ENCEPHALITIS VIRUS; LEDUM PALUSTRE TWIG; NEISSERIA MENINGITIDIS; HEPATITIS B VIRUS 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 15; 15; 15; 15; 30; 30; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0485_440bd17a-60fa-4ee8-ad4a-6e5cba2f594d 43742-0485 HUMAN OTC DRUG Candida Plus Echinacea (Angustifolia), Hydrastis canadensis, Phytolacca decandra, Alternaria tenuis, Aspergillus niger, Geotrichum candidum, Mucor racemosus, Pullularia pullulans, Rhizopus nigricans, LIQUID ORAL 20140520 20200625 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; GEOTRICHUM CANDIDUM; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; ACETALDEHYDE; CAFFEIC ACID; GALLIC ACID MONOHYDRATE; INDOLE; YEAST MANNAN; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SACCHAROMYCES CEREVISIAE; CANDIDA ALBICANS 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0486_1f6b1c4a-a2de-4fab-9ef2-051898cbfb23 43742-0486 HUMAN OTC DRUG Intestinal Distress Echinacea (Angustifolia), Colchicum Autumnale, Aloe, Colocynthis, Mercurius Corrosivus, Nux Vomica, Arsenicum Album, Clostridium Difficile, Chininum Sulphuricum, Cholera Nosode, Campylobacter Jejuni, Colibacillinum Cum Natrum Muriaticum, Helicobacter Pylori, Shigella, Yersinia Enterocolitica, Clostridium Botulinum, Salmonella Typhi Nosode LIQUID ORAL 20140926 20200521 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; COLCHICUM AUTUMNALE BULB; ALOE; CITRULLUS COLOCYNTHIS FRUIT PULP; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED; ARSENIC TRIOXIDE; CLOSTRIDIUM DIFFICILE; QUININE SULFATE; VIBRIO CHOLERAE; CAMPYLOBACTER JEJUNI; ESCHERICHIA COLI; HELICOBACTER PYLORI; SHIGELLA DYSENTERIAE; YERSINIA ENTEROCOLITICA; BOTULINUM TOXIN TYPE A; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 3; 4; 6; 6; 6; 6; 6; 8; 12; 12; 30; 30; 30; 30; 30; 30; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0487_5ff3b343-ae67-4408-bc54-cbba9876a1e2 43742-0487 HUMAN OTC DRUG Healing Support Betula (Pendula), Cortex), Caltha Palustris, Galium Aparine, Sedum Acre, Thuja Occidentalis, Urtica Urens, Clematis Erecta, Hedera Helix, Juniperus Communis, Quillaja Saponaria, Sempervivum Tectorum, Echinacea (Angustifolia), Nitricum Acidum, Argentum Metallicum, Calcarea Fluorica, Phosphorus, Apis Mellifica, Pyrogenium, Ononis Spinosa LIQUID ORAL 20140530 20200702 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETULA PENDULA BARK; CALTHA PALUSTRIS; GALIUM APARINE; SEDUM ACRE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; CLEMATIS RECTA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; QUILLAJA SAPONARIA BARK; SEMPERVIVUM TECTORUM LEAF; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; SILVER; CALCIUM FLUORIDE; PHOSPHORUS; APIS MELLIFERA; RANCID BEEF; ONONIS SPINOSA WHOLE 2; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 12; 12; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0488_2983697e-68c9-47b0-b0fa-11996fa8c4d7 43742-0488 HUMAN OTC DRUG Post-Dental Visit Chamomilla, Echinacea (Angustifolia), Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Bryonia (Alba), Calendula Officinalis, Arnica Montana, Belladonna, Bellis Perennis, Rhus Tox, Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Hepar Sulphuris Calcareum, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos, Carbo Vegetabilis LIQUID ORAL 20140529 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; TOXICODENDRON PUBESCENS LEAF; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; CALCIUM SULFIDE; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; ACTIVATED CHARCOAL 3; 3; 3; 3; 3; 4; 4; 4; 6; 6; 6; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0489_b1d8c655-31fe-4b99-918a-491f4bd49a38 43742-0489 HUMAN OTC DRUG Nerve Z Condurango, Echinacea (Angustifolia), Ginkgo biloba, Hydrastis canadensis, Myrrha, Ligusticum porteri, Phytolacca decandra, Tabebuia impetiginosa, Propolis, Glandula suprarenalis suis, Spleen (Suis), Thymus (Suis), Thyroidinum (Suis), Gelsemium sempervirens, Lycopodium clavatum, Nux vomica, Selenium metallicum, Pyrogenium LIQUID ORAL 20140702 20200717 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MARSDENIA CONDURANGO BARK; ECHINACEA ANGUSTIFOLIA; GINKGO; GOLDENSEAL; MYRRH; LIGUSTICUM PORTERI ROOT; PHYTOLACCA AMERICANA ROOT; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; THYROID, PORCINE; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SELENIUM; RANCID BEEF 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0490_d7573945-558c-4f79-8a52-fa3716a6c6a5 43742-0490 HUMAN OTC DRUG Liver Drainage Chelidonium Majus, Carduus Marianus, Schisandra Chinensis, Taraxacum Officinale, Berberis Vulgaris, Picrorhiza Scrophulariiflora, Raphanus Sativus, Viscum Album, Chromium Gluconate, Cobalt Gluconate, Copper Gluconate, Magnesium Gluconate, Natrum Sulphuricum, Ptelea Trifoliate, Sarcolacticum Acidum, Sulphur Iodatum, Carbolicum Acidum, Cichorium Intybus, Flos, Gallbladder (Suis), Hepar Suis, Nux Vomica, Pancreas Suis, Vanadium Metallicum, Verbena Officinalis, Flos LIQUID ORAL 20140621 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHELIDONIUM MAJUS; MILK THISTLE; SCHISANDRA CHINENSIS FRUIT; TARAXACUM OFFICINALE; BERBERIS VULGARIS ROOT BARK; NEOPICRORHIZA SCROPHULARIIFLORA ROOT; RADISH; VISCUM ALBUM FRUITING TOP; CHROMIUM GLUCONATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; MAGNESIUM GLUCONATE; SODIUM SULFATE; PTELEA TRIFOLIATA BARK; LACTIC ACID, L-; SULFUR IODIDE; PHENOL; CICHORIUM INTYBUS FLOWER; SUS SCROFA GALLBLADDER; PORK LIVER; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; VANADIUM; VERBENA OFFICINALIS FLOWERING TOP 1; 2; 2; 2; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0491_8e9656cb-75d2-45f2-9527-1d0003d28e11 43742-0491 HUMAN OTC DRUG Radiation Plus Chondrus Crispus, Fucus Vesiculosus, Thyroidinum (Suis), Cadmium Iodatum, Cadmium Sulphuratum, Iodium, Uranium Nitricum, Radium Bromatum, Strontium Carbonicum, X-Ray, Arnica Montana LIQUID ORAL 20140621 20210825 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHONDRUS CRISPUS; FUCUS VESICULOSUS; SUS SCROFA THYROID; CADMIUM IODIDE; CADMIUM SULFIDE; IODINE; URANYL NITRATE HEXAHYDRATE; RADIUM BROMIDE; STRONTIUM CARBONATE; ALCOHOL, X-RAY EXPOSED (1000 RAD); ARNICA MONTANA 3; 3; 8; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0492_38bbd8c7-7a40-4e57-872b-5229d417c266 43742-0492 HUMAN OTC DRUG Rheumatoid Arthritis Nosode Adenosinum Triphosphoricum Dinatrum, Malic Acid, Natrum Oxalaceticum, Oroticum Acidum, Riboflavinum, Apiolum, Cinnamic Acid, DHEA (Dehydroepiandrosterone), Streptococcus Viridans, Borrelia Burgdorferi Nosode, Brucella Abortus, Calcarea Carbonica, Campylobacter Jejuni, Chlamydia Trachomatis, Klebsiella Pheumoniae, Mycoplasma Pneumoniae, Yersinia Enterocolitica, Pneumococcinum, Streptococcus Agalactiae, Enterococcus Faecalis, Streptococcus Mutans, Salmonella Enteritidis, Dysentery Bacillus, Shigella Sonnei LIQUID ORAL 20140621 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; MALIC ACID; SODIUM DIETHYL OXALACETATE; OROTIC ACID MONOHYDRATE; RIBOFLAVIN; APIOLE (PARSLEY); CINNAMIC ACID; PRASTERONE; STREPTOCOCCUS VIRIDANS GROUP; BORRELIA BURGDORFERI; BRUCELLA ABORTUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAMPYLOBACTER JEJUNI; CHLAMYDIA TRACHOMATIS; KLEBSIELLA PNEUMONIAE; MYCOPLASMA PNEUMONIAE; YERSINIA ENTEROCOLITICA; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS AGALACTIAE; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS MUTANS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SHIGELLA SONNEI; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS UBERIS; PROTEUS MORGANII; STREPTOCOCCUS EQUINUS 6; 6; 6; 6; 6; 6; 6; 6; 12; 15; 15; 15; 15; 15; 15; 15; 17; 17; 9; 13; 13; 14; 15; 15; 15; 15; 30; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0493_1c2c77ef-034c-40a8-88fe-5bc0ec33d9a4 43742-0493 HUMAN OTC DRUG Iron Mix Phenylalanine, Quercetin, Rutin, Ascorbic acid, Ferrum metallicum, Ferrum muriaticum, Ferrum phosphoricum, Ferrum sulphuricum, Sarcolacticum acidum, LIQUID ORAL 20140523 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHENYLALANINE; QUERCETIN; RUTIN; ASCORBIC ACID; IRON; FERRIC CHLORIDE HEXAHYDRATE; FERROSOFERRIC PHOSPHATE; FERROUS SULFATE; LACTIC ACID, L-; CORTICOTROPIN; PROTEUS VULGARIS; ENTEROCOCCUS FAECALIS 6; 6; 6; 4; 6; 6; 6; 6; 6; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0494_665c3a81-ef89-44ee-907c-ed2b45be3c87 43742-0494 HUMAN OTC DRUG Addiclenz Beta Vulgaris, Boldo, Petroselinum Sativum, Taraxacum Officinale, Arsenicum Album, Belladonna, Cobaltum Metallicum, Cuprum Metallicum, Iodium, Lycopodium Clavatum, Phosphoricum Acidum, Selenium Metallicum, Zincum Metallicum, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methyl Paraben, Propyl Paraben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum, Oxydatum LIQUID ORAL 20140722 20190812 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; PEUMUS BOLDUS LEAF; PETROSELINUM CRISPUM; TARAXACUM OFFICINALE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; COBALT; COPPER; IODINE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SELENIUM; ZINC; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0495_a62f45cf-3f1c-481f-b6ea-6abe3ea361a9 43742-0495 HUMAN OTC DRUG Bacteria Plus Adenosinum Triphosphoricum Dinatrum, Malic Acid, Natrum Oxalaceticum, Oroticum Acidum, Riboflavinum, Apiolum, Cinnamic Acid, Streptococcus Viridans, Pneumococcinum, Colibacillinum Cum Natrum Muriaticum, Echinacea (Angustifolia), Helicobacter Pylori, Mycoplasma Pneumoniae, Proteus (Mirabilis), Proteus (Vulgaris), Pseudomonas Aeruginosa, Yersinia Enterocolitica, Streptococcus Agalactiae, Legionella Pneumophila, Enterococcus Faecalis, Streptococcus Mutans, Listeria Monocytogenes, Dysentery Bacillus LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE PHOSPHATE DISODIUM; MALIC ACID; SODIUM DIETHYL OXALACETATE; OROTIC ACID; RIBOFLAVIN; APIOLE (PARSLEY); CINNAMIC ACID; STREPTOCOCCUS VIRIDANS GROUP; STREPTOCOCCUS PNEUMONIAE; ESCHERICHIA COLI; ECHINACEA ANGUSTIFOLIA; HELICOBACTER PYLORI; MYCOPLASMA PNEUMONIAE; PROTEUS MIRABILIS; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA; STREPTOCOCCUS AGALACTIAE; LEGIONELLA PNEUMOPHILA; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS MUTANS; LISTERIA MONOCYTOGENES; SHIGELLA DYSENTERIAE; SHIGELLA SONNEI; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS UBERIS; PROTEUS MORGANII; STREPTOCOCCUS EQUINUS 6; 6; 6; 6; 6; 6; 6; 12; 15; 15; 15; 15; 15; 15; 15; 15; 17; 9; 11; 13; 13; 14; 15; 15; 15; 15; 30; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0496_77bb9a01-dd9c-4c8d-8901-8ab1a9e267fc 43742-0496 HUMAN OTC DRUG Enviroclenz Berberis Vulgaris, Carduus Marianus, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Sanguinaria Canadensis, Stillingia Sylvatica, Taraxacum Officinale, Trifolium Pratense, Germanium Sesquioxide, Benzinum, Chlorinum, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Methanol, Belladonna, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica Phosphoricum Acidum LIQUID ORAL 20140722 20190731 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; MILK THISTLE; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; SANGUINARIA CANADENSIS ROOT; STILLINGIA SYLVATICA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; GERMANIUM SESQUIOXIDE; BENZENE; CHLORINE; MENTHOL; ATROPA BELLADONNA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; ACETONE; SODIUM TRIPOLYPHOSPHATE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; AMMONIUM CHLORIDE; SODIUM LAURYL SULFATE; TURPENTINE OIL 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 8; 9; 9; 9; 12; 12; 12; 12; 12; 12; 9; 9; 9; 9; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0497_7a2017b6-63ba-4f0f-9f7c-ffc60535f6ed 43742-0497 HUMAN OTC DRUG Streptococcus Remedy Enterococcus faecalis, Pneumococcinum, Streptococcus viridans, Streptococcus mutans LIQUID ORAL 20140731 20201012 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ENTEROCOCCUS FAECALIS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS VIRIDANS GROUP; STREPTOCOCCUS MUTANS 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0498_932973b1-8443-40f2-a323-a3d2591ebe52 43742-0498 HUMAN OTC DRUG Enviroclenz Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Stillingia Sylvatica, Taraxacum Officinale, Trifolium Pratense, Germanium Sesquioxide, Benzinum, Chlorinum, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Methanol, Belladonna, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20140825 20200604 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; STILLINGIA SYLVATICA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; GERMANIUM SESQUIOXIDE; BENZENE; CHLORINE; METHYL ALCOHOL; ATROPA BELLADONNA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; ACETONE; SODIUM TRIPOLYPHOSPHATE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; AMMONIUM CHLORIDE; SODIUM LAURYL SULFATE; TURPENTINE OIL 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 8; 9; 9; 9; 12; 12; 12; 12; 12; 12; 9; 9; 9; 9; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0499_692cf5c6-0218-4212-abf9-4829b128431a 43742-0499 HUMAN OTC DRUG Female Stimulant Aquilegia Vulgaris, Hydrastis Canadensis, Lilium Tigrinum, Bovista, Cypripedium Pubescens, Apiolum, Apis Venenum Purum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Heart (Suis), Kreosotum, Oophorinum (Suis), Uterus (Suis), Folliculinum, Cis-Aconitum Acid, Lachesis Mutus, Magnesia Phosphorica, Mercurius Solubilis, Sepia, Pineal Gland (Suis), Pituitaria Glandula (Suis), Estradiol, Progesterone, Testosterone, Placenta Totalis Suis, Bacillus Faecalis, Mutabile Bacillus (Bach) LIQUID ORAL 20140902 20201208 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AQUILEGIA VULGARIS; GOLDENSEAL; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPERDON UTRIFORME FRUITING BODY; CYPRIPEDIUM PARVIFOLUM ROOT; APIOLE (PARSLEY); APIS MELLIFERA VENOM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK HEART; WOOD CREOSOTE; SUS SCROFA OVARY; SUS SCROFA UTERUS; ESTRONE; ACONITIC ACID, (Z)-; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; SEPIA OFFICINALIS JUICE; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; ESTRADIOL; PROGESTERONE; TESTOSTERONE; SUS SCROFA PLACENTA; ALCALIGENES FAECALIS; ESCHERICHIA COLI 4; 4; 4; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 12; 13; 30; 30; 30; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0500_19710595-87b3-4eb7-a145-ff49aff8889e 43742-0500 HUMAN OTC DRUG Chlamydia Remedy Chlamydia Trachomatis LIQUID ORAL 20140910 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHLAMYDIA TRACHOMATIS 12 [hp_X]/mL N 20181231 43742-0511_a6062e6d-1cc5-4d1f-9a18-4abf2ef0cee8 43742-0511 HUMAN OTC DRUG Metox Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Ascorbic Acid, Cysteinum, Iridium Metallicum, Methionine, Selenium Metallicum, Thyroidinum (Suis), Arsenicum Album, Carbolicum Acidum, Formalinum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Antimonium Crudum, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum LIQUID ORAL 20140911 20191222 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GARLIC; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ASCORBIC ACID; CYSTEINE; IRIDIUM; METHIONINE; SELENIUM; SUS SCROFA THYROID; ARSENIC TRIOXIDE; PHENOL; FORMALDEHYDE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; ANTIMONY TRISULFIDE; ALUMINUM; SILVER; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0512_3eb896f1-bc1a-418d-b71b-cb8cdb41f012 43742-0512 HUMAN OTC DRUG OSTEOREG Asafoetida, Kali Iodatum, Natrum Sulphuricum, Stillingia Sylvatica, Aranea Diadema, Vitamin D3, Hydrocortisone (Cortisol), Mercurius Praecipitatus Ruber, Calcarea Phosphorica, Hekla Lava, Parathyroid Gland (Bovine), Aurum Metallicum, Lycopodium Clavatum, Gaertner Bacillus (Bach) LIQUID ORAL 20141118 20210629 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASAFETIDA; POTASSIUM IODIDE; SODIUM SULFATE; STILLINGIA SYLVATICA ROOT; ARANEUS DIADEMATUS; CHOLECALCIFEROL; HYDROCORTISONE; MERCURIC OXIDE; TRIBASIC CALCIUM PHOSPHATE; HEKLA LAVA; BOS TAURUS PARATHYROID GLAND; GOLD; LYCOPODIUM CLAVATUM SPORE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 4; 4; 4; 6; 6; 6; 8; 8; 8; 8; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0513_b4bcccdb-5c4d-481b-bc32-7553d5bfa87e 43742-0513 HUMAN OTC DRUG EBOLA REMEDY NOT APPLICABLE LIQUID ORAL 20140926 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CROTALUS HORRIDUS HORRIDUS VENOM 8 [hp_X]/mL N 20181231 43742-0514_7a558ae1-2e15-4196-9684-46a0a11d0779 43742-0514 HUMAN OTC DRUG Mineral Balancing and Energy NOT APPLICABLE LIQUID ORAL 20141007 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. VISCUM ALBUM FRUITING TOP; COBALTOUS GLUCONATE; CUPRIC SULFATE; FERROUS FUMARATE; MAGNESIUM ASPARTATE; MANGANESE GLUCONATE; PHOSPHORUS; POTASSIUM ASPARTATE; SODIUM MOLYBDATE; ADENOSINE CYCLIC PHOSPHATE; CEROUS OXALATE NONAHYDRATE; NICKEL ACETATE; CHOLECALCIFEROL; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; ALUMINUM OXIDE; MERCURIC CHLORIDE; PROTEUS MORGANII 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 200; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0515_edb07666-4d84-41c1-9785-434335ece8a9 43742-0515 HUMAN OTC DRUG Addiclenz Beta Vulgaris, Boldo, Chelidonium Majus, Petroselinum Sativum, Taraxacum Officinale, Arsenicum Album, Belladonna, Cobaltum Metallicum, Cuprum Metallicum, Iodium, Lycopodium Clavatum, Phosphoricum Acidum, Selenium Metallicum, Zincum Metallicum, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methyl Paraben, Propyl Paraben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; PETROSELINUM CRISPUM; TARAXACUM OFFICINALE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; COBALT; COPPER; IODINE; LYCOPODIUM COMPLANATUM SPORE; PHOSPHORIC ACID; SELENIUM; ZINC; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0538_c59b42bb-8dfe-46d6-b2f1-f5d1acd89fb4 43742-0538 HUMAN OTC DRUG Influenza Plus Eucalyptus Globulus, Ipecacuanha, Aconitum Napellus, Influenzinum, Respiratory Syncytial Virus Nosode (RSV), Belladonna, Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Kreosotum, Veratrum Viride LIQUID ORAL 20150910 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EUCALYPTUS GLOBULUS LEAF; IPECAC; ACONITUM NAPELLUS; INFLUENZA A VIRUS; INFLUENZA B VIRUS; RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN); ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; WOOD CREOSOTE; VERATRUM VIRIDE ROOT 2; 3; 3; 8; 8; 8; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0539_7e9e519a-aeca-4943-b81e-ea04e9aed570 43742-0539 HUMAN OTC DRUG Virus Plus Influenzinum, Adenoviren Nosode, Herpes Simplex 1, Herpes Simplex 2, Cytomegalovirus Nosode, Epstein-Barr Virus Nosode, Hepatitis B Nosode LIQUID ORAL 20141022 20191223 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. INFLUENZA A VIRUS; INFLUENZA B VIRUS; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578; HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4; HEPATITIS B VIRUS 12; 12; 15; 15; 15; 15; 18; 18; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0540_585a1298-f593-4d56-ab46-f1cf2844b957 43742-0540 HUMAN OTC DRUG Immune Support Echinacea (Angustifolia), Aconitum Napellus, Arnica Montana, Baptisia Tinctoria, Rhus Tox, Sanguinaria Canadensis, Aristolochia Clematitis, Bryonia (Alba), Eupatorium Perfoliatum, Euphorbium Officinarum, Gelsemium Sempervirens, Mercurius Corrosivus, Phytolacca Decandra, Argentum Nitricum, Arsenicum Album, Phosphorus, Pulsatilla (Vulgaris), Sulphur, Thuja Occidentalis, Hepar Sulphuris Calcareum, Lachesis Mutus, Zincum Metallicum, Astragalus Menziesii, Belladonna, Influenzinum, Spleen (Suis), Thymus (Suis), LIQUID ORAL 20150916 20201202 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; ACONITUM NAPELLUS; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; ARISTOLOCHIA CLEMATITIS ROOT; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; MERCURIC CHLORIDE; PHYTOLACCA AMERICANA ROOT; SILVER NITRATE; ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; CALCIUM SULFIDE; LACHESIS MUTA VENOM; ZINC; ASTRAGALUS NUTTALLII LEAF; ATROPA BELLADONNA WHOLE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; VISCUM ALBUM FRUITING TOP; CORTISONE ACETATE; RANCID BEEF 2; 3; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12; 13; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0541_76afd727-81f0-4b24-90e8-a969fea2bbdb 43742-0541 HUMAN OTC DRUG ENT Support Pulsatilla (Vulgaris), Euphorbium Officinarum, Luffa Operculata, Mercurius Iodatus Ruber, Argentum Nitricum, Hepar Sulphuris Calcareum, Influenzinum, Sinusitisinum, Aspergillus Niger, Candida Albicans, Gallicum Acidum, Mucor Racemosus, Mutabile Bacillus LIQUID ORAL 20141022 20201201 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PULSATILLA VULGARIS; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SILVER NITRATE; CALCIUM SULFIDE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; SINUSITISINUM; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; GALLIC ACID MONOHYDRATE; MUCOR RACEMOSUS; ESCHERICHIA COLI 2; 6; 6; 8; 10; 10; 11; 11; 17; 10; 10; 10; 10; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0542_9598a55a-1999-408c-a0fc-52ed05965163 43742-0542 HUMAN OTC DRUG Appetite Control Acetyl Coenzyme A, Adenosinum Triphosphoricum Dinatrum, Adrenal Cortex (Suis), Bacopa Speciosa, Dopamine Hydrochloride, Equol, Gambogia, Oxytocin Acetate, Rhodiola, Stomach (Suis), Thyroidinum (Suis), Chininum Sulphuricum, Cina, Iodium, Lycopodium Clavatum, Phosphorus, Serotonin (Hydrochloride), Morgan Gaertner LIQUID ORAL 20141112 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYL COENZYME A; ADENOSINE TRIPHOSPHATE DISODIUM; SUS SCROFA ADRENAL CORTEX; BACOPA MONNIERI WHOLE; DOPAMINE HYDROCHLORIDE; EQUOL, (+/-)-; GAMBOGE; OXYTOCIN ACETATE; SEDUM ROSEUM ROOT; SUS SCROFA STOMACH; THYROID, PORCINE; QUININE SULFATE; ARTEMISIA CINA PRE-FLOWERING TOP; IODINE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SEROTONIN HYDROCHLORIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0543_be3a2922-a0dc-499e-ba00-1524dc332c99 43742-0543 HUMAN OTC DRUG Male Stimulant Aralia Quinquefolia, Agnus Castus, Ascorbic Acid, Caladium Seguinum, Kali Bromatum, Strychninum Phosphoricum, Cantharis, Damiana, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Orchitinum (Suis), Pituitaria Glandula (Suis), Prostate (Suis), Conium Maculatum, Diencephalon (Suis), Heart (Suis), Ferrum Phosphoricum, Magnesia Phosphorica, Selenium Metallicum, Zincum Metallicum, Pineal (Suis), Cortisone Aceticum, Manganum Phosphoricum, Lycopodium Clavatum, Testosterone, Morgan Gaertner LIQUID ORAL 20141202 20210120 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMERICAN GINSENG; CHASTE TREE; ASCORBIC ACID; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; STRYCHNINE PHOSPHATE DIHYDRATE; LYTTA VESICATORIA; TURNERA DIFFUSA LEAFY TWIG; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; SUS SCROFA TESTICLE; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; CONIUM MACULATUM FLOWERING TOP; SUS SCROFA DIENCEPHALON; PORK HEART; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SELENIUM; ZINC; SUS SCROFA PINEAL GLAND; CORTISONE ACETATE; MANGANESE PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; TESTOSTERONE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 12; 13; 20; 28; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0545_029ca0d7-e95d-4e9b-b279-dd26ff13ce3f 43742-0545 HUMAN OTC DRUG GIARDIA LAMBLIA REMEDY Giardia Lamblia LIQUID ORAL 20141111 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc GIARDIA LAMBLIA 11 [hp_C]/mL N 20181231 43742-0556_b95e766f-2e12-46db-adc0-74acc1b2c154 43742-0556 HUMAN OTC DRUG MENOPAUSE RELIEF Sanguinaria Canadensis, Ignatia Amara, Sepia, Adenosinum Triphosphoricum Disodium, Bryonia (Alba), Cedron, Equol, Sulphur, Apiolum, Lachesis Mutus, Stannum Metallicum, Faecalis (Alkaligenes) LIQUID ORAL 20141209 20200120 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SANGUINARIA CANADENSIS ROOT; STRYCHNOS IGNATII SEED; SEPIA OFFICINALIS JUICE; ADENOSINE TRIPHOSPHATE DISODIUM; BRYONIA ALBA ROOT; SIMABA CEDRON SEED; EQUOL, (+)-; SULFUR; APIOLE (PARSLEY); LACHESIS MUTA VENOM; TIN; ALCALIGENES FAECALIS 3; 4; 4; 6; 6; 6; 6; 6; 6; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0557_7a455d3b-130f-4a25-aa37-290388e9b710 43742-0557 HUMAN OTC DRUG ENERGY CATALYST Viscum Album, Cobalt Gluconate, Cuprum Sulphuricum, Ferrous Fumarate, Magnesium Aspartate, Manganese Gluconate, Phosphorus, Potassium Aspartate, Sodium Molybdate, Adenosinum Cyclophosphorium, Cerium Oxalicum, Nickel Acetate, Vitamin D3, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron Bromium, Cadmium Metallicum, Cesium Chloride, Chromium Metallicum, Cobaltum Metallicum, Cuprum Metallicum LIQUID ORAL 20141210 20190112 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. VISCUM ALBUM FRUITING TOP; COBALTOUS GLUCONATE; CUPRIC SULFATE; FERROUS FUMARATE; MAGNESIUM ASPARTATE; MANGANESE GLUCONATE; PHOSPHORUS; POTASSIUM ASPARTATE; SODIUM MOLYBDATE; ADENOSINE CYCLIC PHOSPHATE; CEROUS OXALATE NONAHYDRATE; NICKEL ACETATE; CHOLECALCIFEROL; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; ALUMINUM OXIDE; MERCURIC CHLORIDE; LEAD; PROTEUS MORGANII 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 200; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0559_86500d4e-f749-4fcb-8555-339d207b2d9c 43742-0559 HUMAN OTC DRUG Virus Plus Influenzinum, Adenoviren Nosode, Herpes Simplex 1, Herpes Simplex 2, Cytomegalovirus Nosode, Epstein-Barr Virus Nosode, Hepatitis B Nosode, Norovirus LIQUID ORAL 20150914 20201203 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. INFLUENZA A VIRUS; INFLUENZA B VIRUS; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ANTIGEN; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4; HEPATITIS B VIRUS; NORWALK VIRUS 12; 15; 15; 15; 15; 18; 18; 33; 33; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0560_9f77c2d3-6b0a-414b-999c-ee747d91d738 43742-0560 HUMAN OTC DRUG VER Artemisia Vulgaris, Filix Mas, Cina, Melilotus Officinalis, Quassia (Amara), Spigelia Anthelmia, Teucrium Marum, Thymus Serpyllum, Silicea, Calcarea Carbonica, Graphites, Iodium, Mercurius Corrosivus, Sabadilla, Ascaris Lumbricoides, Trichinella Spiralis, Enterobius Vermicularis, Taenia Solium, Trichomonas Vaginalis, Giardia Lamblia, Cryptosporidium Parvum, Taenia Saginata LIQUID ORAL 20150119 20200527 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARTEMISIA VULGARIS ROOT; DRYOPTERIS FILIX-MAS ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; MELILOTUS OFFICINALIS TOP; QUASSIA AMARA WOOD; SPIGELIA ANTHELMIA; TEUCRIUM MARUM; THYMUS SERPYLLUM; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; IODINE; MERCURIC CHLORIDE; SCHOENOCAULON OFFICINALE SEED; ASCARIS LUMBRICOIDES; TRICHINELLA SPIRALIS; ENTEROBIUS VERMICULARIS; TAENIA SOLIUM; TRICHOMONAS VAGINALIS; GIARDIA LAMBLIA; CRYPTOSPORIDIUM PARVUM; TAENIA SAGINATA 2; 2; 3; 3; 3; 3; 3; 3; 8; 12; 12; 12; 12; 12; 15; 15; 33; 12; 13; 18; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0561_20284810-ed62-4346-aef7-7ff6634aee37 43742-0561 HUMAN OTC DRUG ASCORBIC ACID ASCORBIC ACID LIQUID ORAL 20150119 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASCORBIC ACID 6 [hp_X]/mL N 20181231 43742-0562_e54aad99-b5e5-412f-becf-d344a3dd4481 43742-0562 HUMAN OTC DRUG CHOLESTEROL Cholesterinum LIQUID ORAL 20150119 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHOLESTEROL 6 [hp_X]/mL N 20181231 43742-0563_7de1b15b-b0b9-4ba8-b384-4d69aabd05ce 43742-0563 HUMAN OTC DRUG CORTISOL Hydrocortisone LIQUID ORAL 20150119 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HYDROCORTISONE 6 [hp_X]/mL N 20181231 43742-0564_93907d1e-db5d-4043-aa36-6070eb16180b 43742-0564 HUMAN OTC DRUG DHEA DHEA (Dehydroepiandrosterone) LIQUID ORAL 20150119 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PRASTERONE 6 [hp_X]/mL N 20181231 43742-0565_dd227734-5b2e-4731-8213-2062e5a01c79 43742-0565 HUMAN OTC DRUG AMOEBA Baptisia Tinctoria, Cajuputum, Capsicum Annuum, Frasera Caroliniensis, Hamamelis Virginiana, Hydrastis Canadensis, Quassia (Amara), Senna (Cassia Angustifolia), Ipecacuanha, Hepar Suis, Pancreas Suis, Spleen (Suis), Belladonna, Cinchona Officinalis, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Selenium Metallicum, Amoeba Axis, Blastocystis Hominis, Cryptosporidium Parvum, Giardia Lamblia, LIQUID ORAL 20150119 20200515 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BAPTISIA TINCTORIA ROOT; CAJUPUT OIL; CAPSICUM; FRASERA CAROLINIENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; GOLDENSEAL; QUASSIA AMARA WOOD; SENNA LEAF; IPECAC; PORK LIVER; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; SELENIUM; AMOEBA PROTEUS; BLASTOCYSTIS HOMINIS; CRYPTOSPORIDIUM PARVUM; GIARDIA LAMBLIA 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0566_8f425ee7-663a-4f1d-a95c-ef18e48178ae 43742-0566 HUMAN OTC DRUG MENOPAUSE RELIEF Sanguinaria Canadensis, Ignatia Amara, Sepia, Adenosinum Triphosphoricum Disodium, Bryonia (Alba), Cedron, DIM (Diindolylmethane), Equol, Sulphur, Apiolum, Lachesis Mutus, Stannum Metallicum, Faecalis (Alkaligenes) LIQUID ORAL 20150219 20201210 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SANGUINARIA CANADENSIS ROOT; STRYCHNOS IGNATII SEED; SEPIA OFFICINALIS JUICE; ADENOSINE TRIPHOSPHATE DISODIUM; BRYONIA ALBA ROOT; SIMABA CEDRON SEED; 3,3'-DIINDOLYLMETHANE; EQUOL, (+)-; SULFUR; APIOLE (PARSLEY); LACHESIS MUTA VENOM; TIN; ALCALIGENES FAECALIS 3; 4; 4; 6; 6; 6; 6; 6; 6; 6; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0571_d7024904-ab55-48b3-9d8d-f7b64c7c0b65 43742-0571 HUMAN OTC DRUG Glucoreg Ascorbic Acid, Pyridoxinum Hydrochloricum, Riboflavinum, Sarcolacticum Acidum, Thiaminum Hydrochloricum, Acetaldehyde, DHEA (Dehydroepiandrosterone), Phloridzinum, Adenosinum Triphosphoricum Dinatrum, alpha-Lipoicum Acidum, Citricum Acidum, Coenzyme A, Fumaricum Acidum, Glyoxal Trimer Dihydrate, Nadidum, Insulinum, Hepar Suis, Pancreas Suis, Glucagon, Baryta Oxalica, Alloxanum, Berberis Vulgaris, Carcinosin, Lycopodium Clavatum, Momordica Balsamina, Phosphoricum Acidum, Phosphorus, Syzygium Jambolanum LIQUID ORAL 20150315 20210406 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASCORBIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; LACTIC ACID, L-; THIAMINE HYDROCHLORIDE; ACETALDEHYDE; PRASTERONE; PHLORIZIN; ADENOSINE TRIPHOSPHATE DISODIUM; THIOCTIC ACID; ANHYDROUS CITRIC ACID; COENZYME A; FUMARIC ACID; GLYOXAL; NADIDE; INSULIN PORK; PORK LIVER; SUS SCROFA PANCREAS; GLUCAGON; BARIUM OXALATE; ALLOXAN; BERBERIS VULGARIS ROOT BARK; HUMAN BREAST TUMOR CELL; LYCOPODIUM CLAVATUM SPORE; MOMORDICA BALSAMINA IMMATURE FRUIT; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; GYMNEMA SYLVESTRE LEAF; FENUGREEK SEED 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0572_0ace1c9a-b1af-4d7a-a109-daf12de3d314 43742-0572 HUMAN OTC DRUG Systemic Drainage Alfalfa, Avena Sativa, Citrus Limonum, Glycyrrhiza Glabra, Uva-Ursi, Taraxacum Officinale, Galium Aparine, Lobelia Inflata, Schisandra Chinensis, Solidago Virgaurea, Tylophora Asthmatica, Berberis Vulgaris, Chelidonium Majus, Hepar Suis, Intestine (Suis), Kidney (Suis), Lung (Suis), Lymph Node (Suis), Magnesium Gluconate, Nux Vomica, Potassium Gluconate, Zincum Gluconicum, Sarcolacticum Acidum, Lacticum Acidum LIQUID ORAL 20150326 20200617 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; LEMON JUICE; GLYCYRRHIZA GLABRA; ARCTOSTAPHYLOS UVA-URSI LEAF; TARAXACUM OFFICINALE; GALIUM APARINE; LOBELIA INFLATA; SCHISANDRA CHINENSIS FRUIT; SOLIDAGO VIRGAUREA FLOWERING TOP; TYLOPHORA INDICA WHOLE; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; PORK LIVER; PORK INTESTINE; PORK KIDNEY; SUS SCROFA LUNG; SUS SCROFA LYMPH; MAGNESIUM GLUCONATE; STRYCHNOS NUX-VOMICA SEED; POTASSIUM GLUCONATE; ZINC GLUCONATE; LACTIC ACID, L-; LACTIC ACID, DL- 1; 1; 1; 1; 1; 2; 3; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0575_73735e75-96bd-4c65-92c4-69714c8a3d05 43742-0575 HUMAN OTC DRUG Grain and Soy Allergen Mix Adenosinum Triphosphoricum Acidum, Coumarinum, Quercetin, Rutin, Ileum (Suis), Jejunum (Suis), Stomach (Suis), Bacillus Thuringiensis (BT Toxin), Bamboo, Barley, Eschscholzia Californica, Corn, Flax Seed, Gossypium Herbaceum, Millet, Milo, Avena Sativa, Oryza Sativa, Rye, Safflower, Sesamum, Sorghum Bicolor, Glycine Max, Saccharum, Helianthus Annuus, Wheat, Gluten, Amaranth, Natrum Sulphuricum, Sarcolacticum Acidum, Triticum Repens, Adrenocorticotrophin, Sycotic Co Bacillus LIQUID ORAL 20150429 20200915 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; COUMARIN; QUERCETIN; RUTIN; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA STOMACH; THURINGIENSIN; BAMBUSA VULGARIS LEAF; BARLEY; ESCHSCHOLZIA CALIFORNICA; CORN; FLAX SEED; GOSSYPIUM HERBACEUM SEED RESIN; MILLET; SORGHUM BICOLOR WHOLE; AVENA SATIVA WHOLE; ORYZA SATIVA WHOLE; RYE; SAFFLOWER; SESAME SEED; GLYCINE MAX WHOLE; SACCHARUM OFFICINARUM WHOLE; HELIANTHUS ANNUUS FLOWERING TOP; WHEAT; WHEAT GLUTEN; AMARANTH; SODIUM SULFATE; LACTIC ACID, L-; ELYMUS REPENS ROOT; CORTICOTROPIN; ENTEROCOCCUS FAECALIS 4; 6; 6; 6; 8; 8; 8; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 30; 6; 6; 6; 6; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0576_08e38660-a1f2-4404-99ed-d565db9542e0 43742-0576 HUMAN OTC DRUG Fruit Allergen Mix Adenosinum Triphosphoricum Dinatrum, Acetaldehyde, Cinnamic Acid, Gallicum Acidum, Hesperidin, Malvin (Chloride), Quercetin, Rutin, Ileum (Suis), Jejunum (Suis), Stomach (Suis), Chlorophyllin, Aceticum Acidum, Arsenicum Album, Ascorbic Acid, Belladonna, Oxalicum Acidum, Sarcolacticum Acidum, Adrenocorticotrophin, Dysentery Bacillus LIQUID ORAL 20150430 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; ACETALDEHYDE; CINNAMIC ACID; GALLIC ACID MONOHYDRATE; HESPERIDIN; MALVIN; QUERCETIN; RUTIN; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA STOMACH; SODIUM COPPER CHLOROPHYLLIN; ACETIC ACID; ASCORBIC ACID; ARSENIC TRIOXIDE; ATROPA BELLADONNA; OXALIC ACID DIHYDRATE; LACTIC ACID, L-; CORTICOTROPIN; SHIGELLA DYSENTERIAE 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 10; 6; 6; 6; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0577_08659784-7453-4f9b-94e0-2a36e3babaec 43742-0577 HUMAN OTC DRUG Sugar and Food Additive Allergen Mix Cinnamic Acid, Phloridzinum, Aspartame, Ileum (Suis), Jejunum (Suis), Stomach (Suis), Malvin (Chloride), Adenosinum Triphosphoricum Dinatrum, Argentum Nitricum, Fructose, Glucose, Lycopodium Clavatum, Sarcolacticum Acidum, Saccharum Lactis, Saccharum Officinale, Adrenocorticotrophin, High Fructose Corn Syrup, Dysentary Bacillus, Maple Sugar, Morgan Gaertner LIQUID ORAL 20150506 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CINNAMIC ACID; PHLORIZIN; ASPARTAME; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA STOMACH; MALVIN; ADENOSINE TRIPHOSPHATE DISODIUM; SILVER NITRATE; FRUCTOSE; DEXTROSE; LYCOPODIUM CLAVATUM SPORE; LACTIC ACID, L-; LACTOSE; SUCROSE; CORTICOTROPIN; HIGH FRUCTOSE CORN SYRUP; SHIGELLA DYSENTERIAE; ACER SACCHARUM SAP; PROTEUS MORGANII 6; 6; 6; 8; 8; 8; 15; 6; 6; 6; 6; 6; 6; 6; 6; 8; 9; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0578_12b6e96b-c077-4f45-b773-fa1dc3beef3a 43742-0578 HUMAN OTC DRUG Egg Allergen Mix Adenosinum Triphosphoricum Dinatrum, L-Asparagine (Monohydrate), Phenylalanine, Quercetin, Ileum (Suis), Jejunum (Suis), Stomach (Suis), Canary Feathers, Cattle Epithelia, Chicken Feathers, Dog Epithelia, Duck Feathers, Gerbil Epithelia, Goat Epithelia, Goose Feathers, Guinea Pig Epithelia, Hamster Epithelia, Hog Epithelia, Horse Epithelia, Mouse Epithelia, Parakeet Feathers, Rabbit Epithelia, Rat Epithelia, Standardized Cat Hair, Ascorbic Acid, Calcarea Carbonica, Ferrum Iodatum, Tetracycline, Egg LIQUID ORAL 20150506 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; ASPARAGINE MONOHYDRATE; PHENYLALANINE; QUERCETIN; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA STOMACH; SERINUS CANARIA FEATHER; BOS TAURUS SKIN; GALLUS GALLUS FEATHER; CANIS LUPUS FAMILIARIS SKIN; ANAS PLATYRHYNCHOS FEATHER; MERIONES UNGUICULATUS SKIN; CAPRA HIRCUS SKIN; ANSER ANSER FEATHER; CAVIA PORCELLUS SKIN; MESOCRICETUS AURATUS SKIN; SUS SCROFA SKIN; EQUUS CABALLUS SKIN; MUS MUSCULUS SKIN; MELOPSITTACUS UNDULATUS FEATHER; ORYCTOLAGUS CUNICULUS SKIN; RATTUS NORVEGICUS SKIN; FELIS CATUS HAIR; ASCORBIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; TETRACYCLINE; EGG; PROTEUS MORGANII 4; 6; 6; 6; 8; 8; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 6; 6; 6; 6; 28; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0579_3476b0f1-a742-401f-8270-042976fd5cd9 43742-0579 HUMAN OTC DRUG Dairy Allergen Mix Adenosinum Triphosphoricum Dinatrum, Apiolum, Benzoicum Acidum, Cholinum, Cinnamic Acid, Coumarinum, Eugenol, Folic Acid, Folliculinum, Formalinum, GABA (Gamma-Aminobutyric Acid), Histaminum Hydrochloricum, L-Asparagine (Monohydrate), Lac Defloratum, Lac Vaccinum, Menadione, Oophorinum (Suis), Phenyl Isothiocyanate, Quercetin, Rutin, Saccharum Lactis, Ileum (Suis), Jejunum (Suis), Stomach (Suis), Sarcolacticum Acidum, Lac Caninum, Lac Felinum, Lac Humanum, Piperine, Calcarea Carbonica LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; APIOLE (PARSLEY); BENZOIC ACID; CHOLINE HYDROXIDE; CINNAMIC ACID; COUMARIN; EUGENOL; FOLIC ACID; ESTRONE; FORMALDEHYDE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE DIHYDROCHLORIDE; ASPARAGINE MONOHYDRATE; SKIM MILK; COW MILK; MENADIONE; SUS SCROFA OVARY; PHENYL ISOTHIOCYANATE; QUERCETIN; RUTIN; LACTOSE; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA STOMACH; LACTIC ACID, L-; CANIS LUPUS FAMILIARIS MILK; FELIS CATUS MILK; HUMAN MILK; PIPERINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; TOXICODENDRON PUBESCENS LEAF; CALCIUM CITRATE; CALCIUM GLUCONATE 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 30; 30; 30; 30; 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0580_f6f1afcf-c306-4259-b3e0-19813883872e 43742-0580 HUMAN OTC DRUG Pre-Dental Visit Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Arvense, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Sarsaparilla (Smilax Regelii), Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos, Aranea Diadema, Calcarea Phosphorica, Ferrum Iodatum, Lymph Node (Suis), Thyroidinum (Suis) LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM ARVENSE TOP; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; NASTURTIUM AQUATICUM; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; SARSAPARILLA; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA LYMPH; SUS SCROFA THYROID 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 5; 5; 5; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0581_d1bef02f-c839-4e6f-bf80-d6b30305db32 43742-0581 HUMAN OTC DRUG Advanced Detox Core Formula Dulcamara, Echinacea Angustifolia, Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid, Coccus Cacti, Conium Maculatum, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Pulsatilla (Vulgaris), Sarcolacticum Acidum, Lymph Node (Suis), Sulphur, Glandula Suprarenalis Suis, L-Phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (Suis), Spleen (Suis), Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Tonsil (Suis), Funiculus Umbilicalis Suis, Gaertner Bacillus, LIQUID ORAL 20150615 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SOLANUM DULCAMARA TOP; ECHINACEA ANGUSTIFOLIA; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; CONIUM MACULATUM FLOWERING TOP; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; PULSATILLA VULGARIS; LACTIC ACID, L-; SUS SCROFA LYMPH; SULFUR; SUS SCROFA ADRENAL GLAND; PHENYLALANINE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA SPLEEN; CORTISONE ACETATE; MERCURIUS SOLUBILIS; BARIUM CARBONATE; SUS SCROFA TONSIL; SUS SCROFA UMBILICAL CORD; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; LIOTHYRONINE; SUS SCROFA BONE MARROW; ESCHERICHIA COLI 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 10; 10; 10; 10; 10; 10; 13; 13; 28; 6; 6; 9; 10; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0582_ad5c6df6-58e7-4013-96b3-6bc7c4a4d899 43742-0582 HUMAN OTC DRUG Hormone Combination Salsolinol Hydrochloride, Cholesterinum, DHEA (Dehydroepiandrosterone), 7-Keto-DHEA (Dehydroepiandrosterone), Folliculinum, Oophorinum (Suis), Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone LIQUID ORAL 20150603 20201027 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SALSOLINOL HYDROCHLORIDE, (+/-)-; CHOLESTEROL; PRASTERONE; 7-KETO-DEHYDROEPIANDROSTERONE; ESTRONE; SUS SCROFA OVARY; PROGESTERONE; TESTOSTERONE; CORTISONE ACETATE; ALDOSTERONE; ANDROSTERONE; FOLLITROPIN 6; 6; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0584_3a825adf-8abf-4db1-b4ba-78f54231b23f 43742-0584 HUMAN OTC DRUG MINERAL BALANCING AND ENERGY Viscum Album, Cobalt Gluconate, Cuprum Sulphuricum, Ferrous Fumarate, Magnesium Aspartate, Manganese Gluconatte, Phosphorus, Potassium Aspartate, Sodium Molybdate, Adenosinum Cyclophosphoricum, Cerium Oxalicum, Nickel Acetate, Vitamin D3, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum LIQUID ORAL 20150721 UNAPPROVED HOMEOPATHIC DESERET BIOLOGICALS, INC. VISCUM ALBUM FRUITING TOP; COBALTOUS GLUCONATE; CUPRIC SULFATE; FERROUS FUMARATE; MAGNESIUM ASPARTATE; MANGANESE GLUCONATE; PHOSPHORUS; POTASSIUM ASPARTATE; SODIUM MOLYBDATE; ADENOSINE CYCLIC PHOSPHATE; CEROUS OXALATE NONAHYDRATE; NICKEL ACETATE; CHOLECALCIFEROL; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANIUM; VANADIUM; YTTERBIUM; ZINC; ALUMINUM OXIDE; MERCURIC CHLORIDE; NIOBIUM; TANTALUM; PROTEUS MORGANII 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0586_dcb85a98-ba2d-47fd-b755-c148afdbdb03 43742-0586 HUMAN OTC DRUG ENERGY CATALYST Viscum Album, Cobalt Gluconate, Cuprum Sulphuricum, Ferrous Fumarate, Magnesium Aspartate, Manganese Gluconate, Phosphorus, Potassium Aspartate, Sodium Molybdate, Adenosinum Cyclophosphoricum, Cerium Oxalicum, Nickel Acetate, Vitamin D3, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum LIQUID ORAL 20150721 20201109 UNAPPROVED HOMEOPATHIC DESERET BIOLOGICALS, INC. VISCUM ALBUM FRUITING TOP; COBALTOUS GLUCONATE; CUPRIC SULFATE; FERROUS FUMARATE; MAGNESIUM ASPARTATE; MANGANESE GLUCONATE; PHOSPHORUS; POTASSIUM ASPARTATE; SODIUM MOLYBDATE; ADENOSINE CYCLIC PHOSPHATE; CEROUS OXALATE NONAHYDRATE; NICKEL ACETATE; CHOLECALCIFEROL; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANIUM; VANADIUM; YTTERBIUM OXIDE; ZINC; ALUMINUM OXIDE; MERCURIC CHLORIDE; LANTHANUM; NIOBIUM; TANTALUM; PROTEUS MORGANII 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 14; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 43742-0587_1ed88c4a-dc0f-4f65-bb42-d6c813f39e55 43742-0587 HUMAN OTC DRUG Metox Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Ascorbic Acid, Cysteinum, Iridium Metallicum, Methionine, Selenium Metallicum, Thyroidinum (Suis), Carbolicum Acidum, Formalinum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum LIQUID ORAL 20150803 20200811 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GARLIC; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ASCORBIC ACID; CYSTEINE; IRIDIUM; METHIONINE; SUS SCROFA THYROID; PHENOL; FORMALDEHYDE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; LANTHANUM; NIOBIUM; TANTALUM 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 14; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0588_3de3806d-49ab-4949-be9a-cd55cbb9ff64 43742-0588 HUMAN OTC DRUG CANDIDA PLUS Echinacea (angustifolia), Hydrastis canadensis, Phytolacca decandra, Acetaldehyde, Caffeic acid, Gallicum acidum, Indolum, Mannan, Lycopodium clavatum, Mercurius solubilis, Pulsatilla (vulgaris), Sepia, Candida albicans, Brugia malayi, Alternaria tenuis nees, Aspergillus niger, Candida albicans, Candida parapsilosis, Mucor racemosus, Pullularia pullulans, Rhizopus nigricans, Torula cerevisiae LIQUID ORAL 20150714 20200805 UNAPPROVED HOMEOPATHIC DESERET BIOLOGICALS, INC. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; ACETALDEHYDE; CAFFEIC ACID; GALLIC ACID MONOHYDRATE; INDOLE; YEAST MANNAN; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; BRUGIA MALAYI 3; 3; 3; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0589_dcc5ea77-bab1-4eef-810c-debd56ac3ef2 43742-0589 HUMAN OTC DRUG VER Artemisia Vulgaris, Filix Mas, Cina, Melilotus Officinalis, Quassia (Amara), Spigelia Anthelmia, Teucrium Marum, Thymus Serpyllum, Silicea, Calcarea Carbonica, Graphites, Iodium, Mercurius Corrosivus, Sabadilla, Ascaris Lumbricoides, Trichinella Spiralis, Enterobius Vermicularis, Taenia Solium, Trichomonas Vaginalis, Giardia Lamblia, Cryptosporidium Parb Um, Taenia Saginata, Brugia Malayi LIQUID ORAL 20150710 20201009 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARTEMISIA VULGARIS ROOT; DRYOPTERIS FILIX-MAS ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; MELILOTUS OFFICINALIS TOP; QUASSIA AMARA WOOD; SPIGELIA ANTHELMIA; TEUCRIUM MARUM; THYMUS SERPYLLUM; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; IODINE; MERCURIC CHLORIDE; SCHOENOCAULON OFFICINALE SEED; ASCARIS LUMBRICOIDES; TRICHINELLA SPIRALIS; ENTEROBIUS VERMICULARIS; TAENIA SOLIUM; TRICHOMONAS VAGINALIS; GIARDIA LAMBLIA; CRYPTOSPORIDIUM PARVUM; TAENIA SAGINATA; BRUGIA MALAYI 2; 2; 3; 3; 3; 3; 3; 3; 8; 12; 12; 12; 12; 12; 15; 15; 33; 12; 13; 18; 20; 20; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0590_3e957dbb-9cb1-4239-a694-9cd156261248 43742-0590 HUMAN OTC DRUG Intestinal Distress Echinacea (Angustifolia), Colchicum Autumnale, Aloe, Colocynthis, Mercurius Corrosivus, Nux Vomica, Arsenicum Album, Clostridium Difficile, Chininum Sulphuricum, Cholera Nosode, Campylobacter Jejuni, Colibacillinum Cum Natrum Muriaticum, Helicobacter Pylori, Shigella, Yersinia Enterocolitica, Botulinum Nosode, Salmonella Typhi Nosode, Brugia Malayi LIQUID ORAL 20150710 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; COLCHICUM AUTUMNALE BULB; ALOE; CITRULLUS COLOCYNTHIS FRUIT PULP; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED; ARSENIC TRIOXIDE; CLOSTRIDIUM DIFFICILE; QUININE SULFATE; VIBRIO CHOLERAE; CAMPYLOBACTER JEJUNI; ESCHERICHIA COLI; HELICOBACTER PYLORI; SHIGELLA DYSENTERIAE; YERSINIA ENTEROCOLITICA; BOTULINUM TOXIN TYPE A; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; BRUGIA MALAYI 3; 4; 6; 6; 6; 6; 6; 8; 12; 12; 30; 30; 30; 30; 30; 30; 33; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0599_ae5cf667-11b0-4820-8c13-28ad6df58c7f 43742-0599 HUMAN OTC DRUG Upper Respiratory Staph Step Combination Staphylococcus Aureus, Klebsiella Pneumoniae, Enterococcus Faecalis, Pneumococcinum, Streptococcus Agalactiae, Streptococcus Mutans, Haemophilus Influenzae B, Streptococcus Viridans TABLET ORAL 20150730 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. STAPHYLOCOCCUS AUREUS; KLEBSIELLA PNEUMONIAE; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS MUTANS; HAEMOPHILUS INFLUENZAE TYPE B; STREPTOCOCCUS VIRIDANS GROUP 15; 15; 12; 12; 12; 12; 12; 36 [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 43742-0600_7c27fcfd-48a0-49f1-be8d-0a04e224f03c 43742-0600 HUMAN OTC DRUG Professional Weight Support Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Gambogia, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto (3-Acetyl-7-Oxo-Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (Suis), Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20150728 UNAPPROVED HOMEOPATHIC Desert Biologicals, Inc. CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; GAMBOGE; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0601_895d76e9-2f89-4028-a61d-7049fa1f3bc5 43742-0601 HUMAN OTC DRUG Enviroclenz Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Stillingia Sylvatica, Taraxacum Officinale, Trifolium Pratense, Germanium Sesquioxide, Benzinum, Chlorinum, Acetone, Ammonium Muriaticum, Propylene Glycol, Sodium Benzene Sulfonate, Sodium Lauryl Sulfate, Sodium Tripolyphosphate, Terebinthina, Methanol, Belladonna, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20150716 20200410 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; STILLINGIA SYLVATICA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; GERMANIUM SESQUIOXIDE; BENZENE; CHLORINE; ACETONE; AMMONIUM CHLORIDE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; TURPENTINE OIL; METHYL ALCOHOL; ATROPA BELLADONNA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0606_f0147be4-2c51-43ef-ada7-2b21169c114a 43742-0606 HUMAN OTC DRUG hA2cg EVOLUTION Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Brain (Suis), Hepar Suis, Methylcobalamin, Pancreas Suis, Kidney (Suis), Stomach (Suis), AACG-A, AACG-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-KETO-DHEA (3- Acetyl-Oxo-Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (Suis), Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20150813 20200825 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0628_2425ed97-9da9-4d92-926a-0c008219972c 43742-0628 HUMAN OTC DRUG FNG Berberis Vulgaris, Cochlearia Armoracia, Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Tabebuia Impetiginosa, Propolis, Formalinum, Glandula Suprarenalis Suis, Thymus (Suis), Ferrum Metallicum, Iridium Metallicum, Lycopodium Clavatum, Phosphoricum Acidum, Pulsatilla (Vulgaris), Selenium Metallicum, Zincum Metallicum, Adenosinum Triphosphoricum Dinatrum, Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Pullularia Pullulans LIQUID ORAL 20150721 20201027 UNAPPROVED HOMEOPATHIC DESERET BIOLOGICALS, INC. BERBERIS VULGARIS ROOT BARK; HORSERADISH; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; FORMALDEHYDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; IRON; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PULSATILLA VULGARIS; SELENIUM; ZINC; ADENOSINE TRIPHOSPHATE DISODIUM; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; METHYLCOBALAMIN; LACTIC ACID, L-; STACHYBOTRYS CHARTARUM; ESCHERICHIA COLI; BRUGIA MALAYI 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0629_a6077d16-83c2-41b4-9d6d-6c7e24bceec2 43742-0629 HUMAN OTC DRUG AMOEBA Baptisia Tinctoria, Cajuputum, Capsicum Annuum, Frasera Caroliniensis, Hamamelis Virginiana, Hydrastis Canadensis, Quassia (Amara), Senna, (Cassia Angustifolia), Ipecacuanha, Hepar Suis, Pancreas Suis, Spleen (Suis), Belladonna, Cinchona Officinalis, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Selenium Metallicum Amoeba Axis, Blastocystis Hominis, Cryptosporidium Parvum, Giardia Lamblia, Brugia Malayi LIQUID ORAL 20150721 20201102 UNAPPROVED HOMEOPATHIC DESERET BIOLOGICALS, INC. BAPTISIA TINCTORIA ROOT; CAJUPUT OIL; CAPSICUM; FRASERA CAROLINIENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; GOLDENSEAL; QUASSIA AMARA WOOD; SENNA LEAF; IPECAC; PORK LIVER; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; SELENIUM; AMOEBA PROTEUS; BLASTOCYSTIS HOMINIS; CRYPTOSPORIDIUM PARVUM; GIARDIA LAMBLIA; BRUGIA MALAYI 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0630_53af7900-fcd5-4cf5-9bbb-b20fa8521fb6 43742-0630 HUMAN OTC DRUG Iron Mix System Formula Phenylalanine, Quercetin, Rutin, Ascorbicum Acidum, Ferrum Metallicum, Ferrum Muriaticum, Ferrum Phosphoricum, Ferrum Sulphuricum, Sarcolacticum Acidum, Adrenocorticotrophin, Proteus (Vulgaris), Sycotic Co Bacillus LIQUID ORAL 20150901 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHENYLALANINE; QUERCETIN; RUTIN; ASCORBIC ACID; IRON; FERRIC CHLORIDE HEXAHYDRATE; FERROSOFERRIC PHOSPHATE; FERROUS SULFATE; LACTIC ACID, L-; CORTICOTROPIN; PROTEUS VULGARIS; ENTEROCOCCUS FAECALIS 6; 6; 6; 4; 6; 6; 6; 6; 6; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0631_ee8d7422-f9b8-4019-86b2-a980f6673e8d 43742-0631 HUMAN OTC DRUG Mucous Membrane Core Formula Ceanothus Americanus, Hydrastis Canadensis, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (Vulgaris), Bile Duct (Suis), Colon (Suis), Duodenum (Suis), Esophagus (Suis), Eye (Suis), Gallbladder (Suis), Ileum (Suis), Intestine (Suis), Ipecacuanha, Jejunum (Suis), Kali Bichromicum, Lung (Suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (Suis), Pancreas Suis, Phosphorus, Rectal Mucosa (Suis) LIQUID ORAL 20150824 20210329 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PULSATILLA VULGARIS; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; ATROPA BELLADONNA WHOLE; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 4; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0632_fcf472db-6124-4cc7-b48b-d271f4312f09 43742-0632 HUMAN OTC DRUG Electrolyte Plus Boron Gluconate, Calcium Gluconate, Chromium Gluconate, Cobalt Gluconate, Copper Gluconate, Ferrous Gluconate, Potassium Gluconate, Magnesium Gluconicum Dihydricum, Manganese Gluconate, Sodium Gluconate, Nickel Gluconate, Selenium Dioxide, Zincum Gluconicum, Kali Phosphoricum, Vanadium Metallicum, Calcarea Phosphorica LIQUID ORAL 20150901 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BORON GLUCONATE; CALCIUM GLUCONATE; CHROMIUM GLUCONATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; FERROUS GLUCONATE; POTASSIUM GLUCONATE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; SODIUM GLUCONATE; NICKEL GLUCONATE; SELENIUM DIOXIDE; ZINC GLUCONATE; POTASSIUM PHOSPHATE, DIBASIC; VANADIUM; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0633_51be1b6a-bf19-4e00-819e-4f7ae1fcff65 43742-0633 HUMAN OTC DRUG Grain Mix System Formula Coumarinum, Quercetin, Rutin, Bamboo, Barley, Corn, Levant Cotton, Flax, Millet, Milo, Oat, California Poppy, Rice, Rye, Safflower, Sesame, Sorghum, Soybean, Sugarcane, Sunflower, Wheat, Amaranth, Oat, Natrum Sulphuricum, Sarcolacticum Acidum, Triticum Repens, Adrenocorticotrophin, Sycotic Co Bacillus LIQUID ORAL 20150902 20201016 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COUMARIN; QUERCETIN; RUTIN; BAMBUSA VULGARIS LEAF; BARLEY; CORN; LEVANT COTTON SEED; FLAX SEED; MILLET; SORGHUM BICOLOR WHOLE; AVENA SATIVA FLOWERING TOP; ESCHSCHOLZIA CALIFORNICA; ORYZA SATIVA WHOLE; RYE; SAFFLOWER; SESAME SEED; SOYBEAN; SUCROSE; HELIANTHUS ANNUUS FLOWERING TOP; WHEAT; AMARANTH; SODIUM SULFATE; LACTIC ACID, L-; ELYMUS REPENS ROOT; CORTICOTROPIN; ENTEROCOCCUS FAECALIS 6; 6; 6; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 6; 6; 6; 6; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0634_3c553420-c163-49a4-9257-1b4bd062af9d 43742-0634 HUMAN OTC DRUG Coxsackie Remedy Coxsackie Nosode A2, A7, B1, B3, B4 LIQUID ORAL 20150923 20201013 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B3; HUMAN COXSACKIEVIRUS B4 7; 7; 7; 7; 7 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0635_6cf659ba-03bc-4a51-b89f-8a74bf445f06 43742-0635 HUMAN OTC DRUG Mineral Balancing and Energy Core Formula Viscum Album, Cobalt Gluconate, Cuprum Sulphuricum, Ferrous Fumarate, Magnesium Aspartate, Manganese Gluconate, Phosphorus, Potassium Aspartate, Sodium Molybdate, Adenosinum Cyclophosphoricum, Cerium Oxalicum, Nickel Acetate, Vitamin D3, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum LIQUID ORAL 20150902 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. VISCUM ALBUM FRUITING TOP; COBALTOUS GLUCONATE; CUPRIC SULFATE; FERROUS FUMARATE; MAGNESIUM ASPARTATE; MANGANESE GLUCONATE; PHOSPHORUS; POTASSIUM ASPARTATE; SODIUM MOLYBDATE; ADENOSINE CYCLIC PHOSPHATE; CEROUS OXALATE NONAHYDRATE; NICKEL ACETATE; CHOLECALCIFEROL; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM; ZINC; ALUMINUM OXIDE; MERCURIC CHLORIDE; LEAD; LANTHANUM; NIOBIUM; TANTALUM; PROTEUS MORGANII 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 200; 14; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0647_a2bd6a16-8eb6-4151-9f32-1b501f946a22 43742-0647 HUMAN PRESCRIPTION DRUG Systemic Drainage Alfalfa, Avena Sativa, Citrus Limonum, Glycyrrhiza Glabra, Uva-Ursi, Taraxacum Officinale, Galium Aparine, Schisandra Chinensis, Solid Ago Virgaurea, Tabacum, Tylophora Asthmatica, Berberis Vulgaris, Chelidonium Majus, Hepar Suis, Intestine (Suis), Kidney (Suis), Lung (Suis), Lymph Node (Suis), Magnesium Gluconate, Nux Vomica, Potassium Gluconate, Zincum Gluconicum, Sarcolacticum Acidum, Lacticum Acidum LIQUID ORAL 20151103 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; LEMON JUICE; GLYCYRRHIZA GLABRA; ARCTOSTAPHYLOS UVA-URSI LEAF; TARAXACUM OFFICINALE; GALIUM APARINE; SCHISANDRA CHINENSIS FRUIT; SOLIDAGO VIRGAUREA FLOWERING TOP; TOBACCO LEAF; TYLOPHORA INDICA LEAF; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; PORK LIVER; PORK INTESTINE; PORK KIDNEY; SUS SCROFA LUNG; SUS SCROFA LYMPH; MAGNESIUM GLUCONATE; STRYCHNOS NUX-VOMICA SEED; POTASSIUM GLUCONATE; ZINC GLUCONATE; LACTIC ACID, L-; LACTIC ACID, DL- 1; 1; 1; 1; 1; 2; 3; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 43742-0648_c0a60a3f-1efc-4467-96d9-79a5e080725a 43742-0648 HUMAN OTC DRUG Neuro II Hydrastis Canadensis, Taraxacum Officinale, Acetylcholine Chloride, Adrenalinum, GABA, Histaminum Hydrochloricum, Norepinephrine, Tyramine LIQUID ORAL 20151106 20210405 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GOLDENSEAL; TARAXACUM OFFICINALE; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE DIHYDROCHLORIDE; NOREPINEPHRINE; TYRAMINE 3; 3; 6; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0649_9a3136e5-f31e-43dc-b47a-22fb05a3e0bc 43742-0649 HUMAN OTC DRUG Cerebromax Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, GABA, Norepinephrine, Octopamine, Serotonin (Hydrochloride), Taurine, Adenosinum Cyclophosphoricum, Cerebrum Suis, Diencephalon (Suis), Pineal Gland (Suis), Thalamus Opticus (Suis) LIQUID ORAL 20151111 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; EPINEPHRINE; DOPAMINE HYDROCHLORIDE; .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; TAURINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0650_a344dfc5-434f-4f68-9a91-810cb490ee39 43742-0650 HUMAN OTC DRUG Detox II Solidago Virgaurea, Baptisia Tinctoria, Berberis Vulgaris, Equisetum Hyemale, Argentum Nitricum, Cantharis, Capsicum Annuum, Cuprum Sulphuricum, Orthosiphon Stamineus, Pareira Brava, Sarsaparilla (Smilax Regelii), Terebinthina, Apis Venenum Purum, Barosma (Betulina), Mercurius Corrosivus, Pyelon (Suis), Ureter (Suis), Urethra (Suis), Urinary Bladder (Suis), Glyoxal Trimer Dihydrate, Hepar Sulphuris Calcareum, Natrum Pyruvicum, Quercetin, Colibacillinum Cum Natrum Muriaticum, Dysentery Bacillus LIQUID ORAL 20151118 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SOLIDAGO VIRGAUREA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; SILVER NITRATE; LYTTA VESICATORIA; CAPSICUM; CUPRIC SULFATE; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; TURPENTINE OIL; APIS MELLIFERA VENOM; AGATHOSMA BETULINA LEAF; MERCURIC CHLORIDE; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; GLYOXAL TRIMER DIHYDRATE; CALCIUM SULFIDE; SODIUM PYRUVATE; QUERCETIN; ESCHERICHIA COLI; SHIGELLA DYSENTERIAE 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0652_6d047bd8-9c4d-481e-847e-0d4e5f85f40e 43742-0652 HUMAN OTC DRUG Pericardium Triple Warmer Meridian Opener Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Calcarea Carbonica, Glonoinum, Iodium, Kali Iodatum, Lachesis Mutus, Lithium Carbonicum, Mercurius Solubilis, Naja Tripudians, Phosphoricum Acidum, Phosphorus, Sepia, Spongia Tosta, Tabacum, Thyroidinum (Suis) LIQUID ORAL 20151117 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; NITROGLYCERIN; IODINE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LITHIUM CARBONATE; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; PHOSPHORIC ACID; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SPONGIA OFFICINALIS SKELETON, ROASTED; TOBACCO LEAF; THYROID, PORCINE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0653_b1f75d93-dc98-493e-a7ea-fc6e8a54f9cb 43742-0653 HUMAN OTC DRUG Brain Balance Core Formula Acetylcholine Chloride, Dopamine Hydrochloride, GABA (Gamma-Aminobutyric Acid), Octopamine (Hydrochloride), Serotonin (Hydrochloride), Taurine, Adenosinum Cyclophosphoricum, Cerebrum (Suis), Diencephalon (Suis), Pineal Gland (Suis), Thalamus Opticus (Suis) LIQUID ORAL 20151117 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE; DOPAMINE HYDROCHLORIDE; .GAMMA.-AMINOBUTYRIC ACID; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; TAURINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0654_74b17d84-6090-4ddb-9d7c-cea41441b288 43742-0654 HUMAN OTC DRUG Borrelia Babesia Remedy Babesia Microti, Borrelia Burgdorferi Nosode LIQUID ORAL 20151111 20210801 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BABESIA MICROTI; BORRELIA BURGDORFERI 15; 15 [hp_X]/mL; [hp_X]/mL N 20181231 43742-0655_bf574f28-be9d-4f95-9543-49c817f9de55 43742-0655 HUMAN OTC DRUG Bartonella Remedy Bartonella Bacilliformis ,Bartonella Clarridgeiae, Bartonella Elizabethae, Bartonella Henselae, Bartonella Quintana, Bartonella Vinsonii, Bartonella Washoensis LIQUID ORAL 20151112 20210210 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BARTONELLA BACILLIFORMIS; BARTONELLA CLARRIDGEIAE; BARTONELLA ELIZABETHAE; BARTONELLA HENSELAE; BARTONELLA QUINTANA; BARTONELLA VINSONII; BARTONELLA WASHOENSIS 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0656_40b885c2-148f-40ee-b411-b3e076a1d044 43742-0656 HUMAN OTC DRUG Bio Cytotox Phase Colchicum Autumnale, Conium Maculatum, Hydrastis Canadensis, Vaccinium Myrtillus, Podophyllum Peltatum, Ascorbic Acid, Galium Aparine, Nicotinamidum, Pyridoxinum Hydrochloricum, Norepinephrine, Alpha-Lipoicum Acidum, Natrum Oxalaceticum, Sulphur, Acetylsalicylicum Acidum, Adenosinum Triphosphoricum Dinatrum, Anthraquinone, Coenzyme A, Histaminum Hydrochloricum, Magnesium Gluconate, Nadidum, Naphthoquinone, Ubidecarenonum, Manganum Phosphoricum, Hydroquinone, Morgan Gaertner LIQUID ORAL 20151111 20201217 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; BILBERRY; PODOPHYLLUM; ASCORBIC ACID; GALIUM APARINE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; LACTIC ACID, L-; THIAMINE HYDROCHLORIDE; NOREPINEPHRINE; THIOCTIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; ASPIRIN; ADENOSINE TRIPHOSPHATE DISODIUM; ANTHRAQUINONE; COENZYME A; HISTAMINE DIHYDROCHLORIDE; MAGNESIUM GLUCONATE; NADIDE; NAPHTHOQUINE; UBIDECARENONE; MANGANESE PYROPHOSPHATE; HYDROQUINONE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 4; 4; 4; 5; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0657_db49294b-917c-4b73-951c-56d91cccbc35 43742-0657 HUMAN OTC DRUG Addiclenz Beta Vulgaris, Boldo, Chelidonium Majus, Petroselinum Sativum, Taraxacum Officinale, Arsenicum Album, Belladonna, Cobaltum Metallicum, Cuprum Metallicum, Iodium, Lycopodium Clavatum, Phosphoricum Acidum, Selenium Metallicum, Zincum Metallicum, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methyl Paraben, Propyl Paraben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum LIQUID ORAL 20151110 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; PETROSELINUM CRISPUM; TARAXACUM OFFICINALE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; COBALT; COPPER; IODINE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SELENIUM; ZINC; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0658_aa9d07aa-1782-46fe-a986-38e3e43ace06 43742-0658 HUMAN OTC DRUG Taurine Taurine LIQUID ORAL 20151110 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TAURINE 6 [hp_X]/mL N 20181231 43742-0659_c9be7e37-167b-46ef-8c35-7e39a139cfb1 43742-0659 HUMAN OTC DRUG Cinnamic Acid Cinnamic Acid LIQUID ORAL 20151111 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CINNAMIC ACID 6 [hp_X]/mL N 20181231 43742-0660_5005e6bc-3ce5-4966-a61d-b8fbf8591556 43742-0660 HUMAN OTC DRUG Arthritis Joints Gnaphalium Polycephalum, Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Borax, Cuprum Aceticum, Kali Carbonicum, Pulsatilla (Vulgaris), Secale Cornutum, Ammonium Muriaticum, Silicea, Argentum Metallicum, Calcarea Phosphorica, Glandula Suprarenalis Suis, Mercurius Praecipitatus Ruber, Sepia, Zincum Metallicum, Palladium Metallicum, Picricum Acidum, Sulphur, Cartilago Suis, Intervertebral Disc (Suis), Medulla Ossis Suis LIQUID ORAL 20151111 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PSEUDOGNAPHALIUM OBTUSIFOLIUM; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; SODIUM BORATE; CUPRIC ACETATE; POTASSIUM CARBONATE; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM; AMMONIUM CHLORIDE; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA ADRENAL GLAND; MERCURIC OXIDE; SEPIA OFFICINALIS JUICE; ZINC; PALLADIUM; PICRIC ACID; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA BONE MARROW 3; 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 8; 8; 10; 10; 10; 10; 10; 10; 12; 12; 30; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0661_a91ecf09-0036-4098-afdd-eb3621f15af2 43742-0661 HUMAN OTC DRUG Metab Ascorbic Acid, Cysteinum, Manganese Gluconate, Alpha-Ketoglutaricum Acidum, Fumaricum Acidum, Germanium Sesquioxide, Iodium, Magnesium Metallicum, Natrum Oxalaceticum, Pulsatilla (Vulgaris), Thyroidinum (Suis), Vanadium Metallicum LIQUID ORAL 20151117 20201204 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc ASCORBIC ACID; CYSTEINE; MANGANESE GLUCONATE; OXOGLURIC ACID; FUMARIC ACID; GERMANIUM SESQUIOXIDE; IODINE; MAGNESIUM; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; THYROID, PORCINE; VANADIUM 6; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0662_5cc0115c-b6af-49e9-b78b-3b53fccd0c94 43742-0662 HUMAN OTC DRUG Norepinephrine Norepinephrine LIQUID ORAL 20151116 20201217 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. NOREPINEPHRINE 6 [hp_X]/mL N 20181231 43742-0663_bf5e72c6-4d54-4f46-8da4-e6657829cd4b 43742-0663 HUMAN OTC DRUG Salsolinol Salsolinol LIQUID ORAL 20151116 20201201 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SALSOLINOL 6 [hp_X]/mL N 20181231 43742-0664_934cdddb-3137-4407-b3b9-592ab77d5ea5 43742-0664 HUMAN OTC DRUG Healing Support Betula (Pendula), Cortex, Caltha Palustris, Galium Aparine, Sedum Acre, Thuja Occidentalis, Urtica Urens, Clematis Erecta, Hedera Helix, Juniperus Communis, Quillaja Saponaria, Sempervivum Tectorum, Echinacea (Angustifolia), Nitricum Acidum, Argentum Metallicum, Calcarea Fluorica, Phosphorus, Apis Mellifica, Pyrogenium, Ononis Spinosa LIQUID ORAL 20151119 20210427 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETULA PENDULA BARK; CALTHA PALUSTRIS; GALIUM APARINE; SEDUM ACRE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; CLEMATIS RECTA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; QUILLAJA SAPONARIA BARK; SEMPERVIVUM TECTORUM LEAF; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; SILVER; CALCIUM FLUORIDE; PHOSPHORUS; APIS MELLIFERA; RANCID BEEF; ONONIS SPINOSA WHOLE 2; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 12; 12; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0665_c42184c7-53eb-41a3-bc7c-f45e05f7ad43 43742-0665 HUMAN OTC DRUG Serotonin Serotonin (Hydrochloride) LIQUID ORAL 20151203 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SEROTONIN HYDROCHLORIDE 6 [hp_X]/mL N 20181231 43742-0666_fc00bbf5-5258-40c6-8b00-fdcf0d387242 43742-0666 HUMAN OTC DRUG Candida Plus Echinacea (Angustifolia), Hydrastis Canadensis, Phytolacca Decandra, Acetaldehyde, Caffeic Acid, Gallicum Acidum, Indolum, Mannan, Lycopodium Clavatum, Mercurius Solubilis, Pulsatilla (Vulgaris), Sepia, Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Pullularia Pullulans, Rhizopus Nigricans, Torula Cerevisiae, Candida Albicans, Brugia Malayi LIQUID ORAL 20151120 20201216 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; ACETALDEHYDE; CAFFEIC ACID; GALLIC ACID MONOHYDRATE; INDOLE; YEAST MANNAN; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; BRUGIA MALAYI 3; 3; 3; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0667_336c2727-f5fe-43f0-a075-8b6319d9add8 43742-0667 HUMAN OTC DRUG Vax Reaction Mezereum, Thuja Occidentalis, Silicea, Calcarea Carbonica, Morbillinum, Parotidinum, Pertussinum, Poliomyelitis Nosode, Rubella Nosode, Tetanus Toxin, Carcinosin, Antimonium Crudum, Ledum Palustre, Thimerosal LIQUID ORAL 20151124 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DAPHNE MEZEREUM BARK; THUJA OCCIDENTALIS LEAFY TWIG; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MEASLES VIRUS; MUMPS VIRUS; BORDETELLA PERTUSSIS; POLIOVIRUS; RUBELLA VIRUS; CLOSTRIDIUM TETANI; HUMAN BREAST TUMOR CELL; ANTIMONY TRISULFIDE; LEDUM PALUSTRE TWIG; THIMEROSAL 6; 6; 8; 30; 30; 30; 30; 30; 30; 30; 15; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0668_e09ee141-0fc7-4bc6-989d-d9769e2fb587 43742-0668 HUMAN OTC DRUG Chronagesic Dulcamara, Arnica Montana, Rhus Tox, Sanguinaria Canadensis, Cartilago Suis, Coenzyme A, Funiculus Umbilicalis Suis, Nadidum, Natrum Oxalaceticum, Placenta Totalis Suis, Sulphur, Chondroitin Sulphate Sodium (Bovine), Methylsulfonylmethane (MSM), Apiolum, Cinnamic Acid, Menadione, Piperine, Alpha-Lipoicum Acidum, Silicea, Symphytum Officinale, Human Growth Hormone, Gaertner Bacillus, Sycotic Co Bacillus LIQUID ORAL 20151203 20210331 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SOLANUM DULCAMARA TOP; ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SUS SCROFA CARTILAGE; COENZYME A; SUS SCROFA UMBILICAL CORD; NADIDE; SODIUM DIETHYL OXALACETATE; SUS SCROFA PLACENTA; SULFUR; CHONDROITIN SULFATE SODIUM (BOVINE); DIMETHYL SULFONE; APIOLE (PARSLEY); CINNAMIC ACID; MENADIONE; PIPERINE; .ALPHA.-LIPOIC ACID; SILICON DIOXIDE; COMFREY ROOT; SOMATROPIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; ENTEROCOCCUS FAECALIS 2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0669_90dffe7d-d105-429a-a3a2-03c05e3a7a0a 43742-0669 HUMAN OTC DRUG Circulation Cactus Grandiflorus, Kali Carbonicum, Kalmia Latifolia, Arnica Montana, Glonoinum, Ignatia Amara, Lacticum Acidum, Ranunculus Bulbosus, Alpha-Ketoglutaricum Acidum, Arsenicum Album, Heart (Suis), Fumaricum Acidum, Hepar Suis, Malic Acid, Natrum Oxalaceticum, Phosphorus, Strophanthus Hispidus, Spigelia Anthelmia, Carbo Vegetabilis, Naja Tripudians, Cytomegalovirus, Epstein-Barr Virus LIQUID ORAL 20151119 20201217 UNAPPROVED HOMEOPATHIC Deseret Biologicals SELENICEREUS GRANDIFLORUS STEM; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; ARNICA MONTANA; NITROGLYCERIN; STRYCHNOS IGNATII SEED; LACTIC ACID, DL-; RANUNCULUS BULBOSUS; OXOGLURIC ACID; ARSENIC TRIOXIDE; PORK HEART; FUMARIC ACID; PORK LIVER; MALIC ACID; SODIUM DIETHYL OXALACETATE; PHOSPHORUS; STROPHANTHUS HISPIDUS SEED; SPIGELIA ANTHELMIA; ACTIVATED CHARCOAL; NAJA NAJA VENOM; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4 3; 4; 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 12; 15; 17; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0670_862184cf-4c6e-4787-a71c-c16a1dad1d2f 43742-0670 HUMAN OTC DRUG Trauma Relief Chamomilla, Echinacea, Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Bryonia (Alba), Calendula Officinalis, Symphytum Officinale, Arnica Montana, Belladonna, Bellis Perennis, Clematis Vitalba, Flos, Helianthemum Nummularium Flos, Impatiens Glandulifera Flos, Ornithogalum Umbellatum Flos, Prunus Cerasifera Flos, Rhus Tox, Hepar Sulphuris Calcareum, Carbo Vegetabilis GEL TOPICAL 20160129 20210408 UNAPPROVED HOMEOPATHIC Deseret Biologicals MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ARNICA MONTANA; ATROPA BELLADONNA WHOLE; BELLIS PERENNIS; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF; CALCIUM SULFIDE; ACTIVATED CHARCOAL 3; 3; 3; 3; 3; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43742-0671_5890dcc6-8bf9-49eb-a1d1-6c3deed8a44d 43742-0671 HUMAN OTC DRUG Sugar Mix System Formula Cinnamic Acid, Phloridzinum, Adenosinum Triphosphoricum Dinatrum, Argentum Nitricum, Beet Sugar, Dextrose, D-Ribose, Fructose, Grape Sugar (Syrup), Lycopodium Clavatum, Maple Sugar, Saccharum Lactis, Saccharum Officinale, Sarcolacticum Acidum, Adrenocorticotrophin, Malvin, Morgan Gaertner, Dysentery Bacillus LIQUID ORAL 20151119 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CINNAMIC ACID; PHLORIZIN; ADENOSINE TRIPHOSPHATE DISODIUM; SILVER NITRATE; SUCROSE; DEXTROSE; RIBOSE, D-; FRUCTOSE; LYCOPODIUM CLAVATUM SPORE; ACER SACCHARUM SAP; LACTOSE; LACTIC ACID, L-; CORTICOTROPIN; MALVIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0672_94311fa0-c8b6-49f2-afb6-b91a11aae081 43742-0672 HUMAN OTC DRUG FNG Berberis Vulgaris, Cochlearia Armoracia, Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Tabebuia Impetiginosa, Propolis, Formalinum, Glandula Suprarenalis Suis, Thymus (Suis), Ferrum Metallicum, Iridium Metallicum, Lycopodium Clavatum, Phosphoricum Acidum, Pulsatilla (Vulgaris), Selenium Metallicum, Zincum Metallicum, Adenosinum Triphosphoricum Dinatrum, Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Pullularia Pullulans LIQUID ORAL 20151203 20201223 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; HORSERADISH; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; FORMALDEHYDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; IRON; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PULSATILLA VULGARIS; SELENIUM; ZINC; ADENOSINE TRIPHOSPHATE DISODIUM; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; METHYLCOBALAMIN; LACTIC ACID, L-; STACHYBOTRYS CHARTARUM; ESCHERICHIA COLI; BRUGIA MALAYI 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0673_279b3144-84f0-4f53-94f0-80ea0af19df9 43742-0673 HUMAN OTC DRUG EMF Protect and Balance Alfalfa, Laminaria Digitata, Symphytum Officinale, Ascorbic Acid, Melatonin, Calcarea Carbonica, Cuprum Metallicum, Ferrum Metallicum, Iodium, Manganum Aceticum, Silicea, Phosphorus, Magnetis Polus Arcticus, Magnetis Polus Australis, X-Ray, Agate, Quartz, Carbon Dioxide, Aconitum Napellus, Arsenicum Album, Gaertner Bacillus (Bach), Kali Carbonicum LIQUID ORAL 20151120 20211223 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALFALFA; LAMINARIA DIGITATA; COMFREY ROOT; ASCORBIC ACID; MELATONIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COPPER; IRON; IODINE; MANGANESE ACETATE TETRAHYDRATE; PHOSPHORUS; ALCOHOL, X-RAY EXPOSED (1000 RAD); SILICON DIOXIDE; CARBON DIOXIDE; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; POTASSIUM CARBONATE 3; 3; 3; 6; 6; 8; 8; 8; 8; 8; 8; 8; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0674_1610641b-29ac-4739-b037-b4986aa67272 43742-0674 HUMAN OTC DRUG Nerve Z Condurango, Echinacea (Angustifolia), Ginkgo Biloba, Hydrastis Canadensis, Ligusticum Porteri, Myrrha, Phytolacca Decandra, Tabebuia Impetiginosa, Propolis, Glandula Suprarenalis Suis, Spleen (Suis), Thymus (Suis), Thyroidinum (Suis), Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Selenium Metallicum, Pyrogenium LIQUID ORAL 20151124 20201213 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MARSDENIA CONDURANGO BARK; ECHINACEA ANGUSTIFOLIA; GINKGO; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; MYRRH; PHYTOLACCA AMERICANA ROOT; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; THYROID, PORCINE; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SELENIUM; RANCID BEEF 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0675_606409b5-a05f-4e28-abe9-f1ddd63dd6e6 43742-0675 HUMAN OTC DRUG VER Artemisia Vulgaris, Filix Mas, Cina, Melilotus Officinalis, Quassia (Amara), Spigelia Anthelmia, Teucrium Marum, Thymus Serpyllum, Silicea, Calcarea Carbonica, Graphites, Iodium, Mercurius Corrosivus, Sabadilla, Ascaris Lumbricoides, Trichinella Spiralis, Enterobius Vermicularis, Taenia Solium, Trichomonas Vaginalis, Giardia Lamblia, Cryptosporidium Parvum, Taenia Saginata, Brugia Malayi LIQUID ORAL 20151120 20210712 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARTEMISIA VULGARIS ROOT; DRYOPTERIS FILIX-MAS ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; MELILOTUS OFFICINALIS TOP; QUASSIA AMARA WOOD; SPIGELIA ANTHELMIA; TEUCRIUM MARUM; THYMUS SERPYLLUM; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; IODINE; MERCURIC CHLORIDE; SCHOENOCAULON OFFICINALE SEED; ASCARIS LUMBRICOIDES; TRICHINELLA SPIRALIS; ENTEROBIUS VERMICULARIS; TAENIA SOLIUM; TRICHOMONAS VAGINALIS; GIARDIA LAMBLIA; CRYPTOSPORIDIUM PARVUM; TAENIA SAGINATA; BRUGIA MALAYI 2; 2; 3; 3; 3; 3; 3; 3; 8; 12; 12; 12; 12; 12; 15; 15; 33; 12; 13; 18; 20; 20; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0676_331eb8a1-0f44-407b-8be1-f2a175c64b47 43742-0676 HUMAN OTC DRUG Carcinosin Carcinosin LIQUID ORAL 20151118 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN BREAST TUMOR CELL 30 [hp_C]/mL N 20181231 43742-0677_6f12ad7d-abeb-4e5c-abeb-5ff6521e7c0a 43742-0677 HUMAN OTC DRUG Testosterone Testosterone LIQUID ORAL 20151202 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TESTOSTERONE 6 [hp_X]/mL N 20181231 43742-0678_ff80e434-e772-4640-a069-b24a1fbc572b 43742-0678 HUMAN OTC DRUG Rocky Mountain Spotted Fever Remedy Rickettsia Nosode LIQUID ORAL 20151120 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. RICKETTSIA RICKETTSII 10 [hp_C]/mL N 20181231 43742-0679_470e9846-d192-4e1f-a7df-34ef659af623 43742-0679 HUMAN OTC DRUG Spinalmax Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Cuprum Aceticum, Nadidum, Natrum Oxalaceticum, Nicotinamidum, Picricum Acidum, Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Alpha-Lipoicum Acidum, Ammonium Muriaticum, Cartilago Suis, Discus Intervertebralis (Suis), Silicea, Argentum Metallicum, Calcarea Phosphorica, Coenzyme A, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis LIQUID ORAL 20151204 20201230 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; CUPRIC ACETATE; NADIDE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PICRIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; .ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; COENZYME A; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SUS SCROFA BONE MARROW; MERCURIC OXIDE; SULFUR; ENTEROBACTER CLOACAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII; PROTEUS VULGARIS 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 28; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0680_8161dc58-c4f5-4d51-ba01-16a2721ff09e 43742-0680 HUMAN OTC DRUG Bronchial Cough Coccus Cacti, Drosera (Rotundifolia), Scilla Maritima, Sticta Pulmonaria, Arsenicum Iodatum, Causticum, Cuprum Aceticum, Carbo Vegetabilis, Kali Carbonicum, Lachesis Mutus LIQUID ORAL 20151204 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PROTORTONIA CACTI; DROSERA ROTUNDIFOLIA; DRIMIA MARITIMA BULB; LOBARIA PULMONARIA; ARSENIC TRIIODIDE; CAUSTICUM; CUPRIC ACETATE; ACTIVATED CHARCOAL; POTASSIUM CARBONATE; LACHESIS MUTA VENOM 4; 4; 4; 4; 6; 6; 6; 12; 12; 12 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL N 20181231 43742-0681_0c0c263d-cd88-47d9-bbf6-74f0b8b4f46c 43742-0681 HUMAN OTC DRUG Female Support Chamomilla, Cimicifuga Racemosa, Cinchona Officinalis, Convallaria Majalis, Crocus Sativus, Helonias Dioica, Hydrastis Canadensis, Mentha Piperita, Senna (Cassia Angustifolia), Valeriana Officinalis, Viola Odorata, Agnus Castus, Ledum Palustre, Lilium Tigrinum, Staphysagria, Cyclamen Europaeum, Cinnamomum, Murex Purpurea, Naja Tripudians LIQUID ORAL 20151204 20201222 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MATRICARIA RECUTITA; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; SAFFRON; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; MENTHA PIPERITA; SENNA LEAF; VALERIAN; VIOLA ODORATA; CHASTE TREE; LEDUM PALUSTRE TWIG; LILIUM LANCIFOLIUM WHOLE FLOWERING; DELPHINIUM STAPHISAGRIA SEED; CYCLAMEN PURPURASCENS TUBER; CINNAMON; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; NAJA NAJA VENOM 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 6; 12; 12; 15 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL N 20181231 43742-0682_639ed99c-6e43-49b4-aac1-d373b7d2d096 43742-0682 HUMAN OTC DRUG Thyroplus Fucus Vesiculosus, Spongia Tosta, Phosphoricum Acidum, Hypophysis (Suis), Thyroidinum (Suis), Calcarea Carbonica, Iodium, Iridium Metallicum LIQUID ORAL 20151204 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; IRIDIUM 3; 4; 6; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0683_df07c3d6-4aa9-44ec-a7a7-d91b6fcde348 43742-0683 HUMAN OTC DRUG Dopamine Dopamine Hydrochloride LIQUID ORAL 20151207 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DOPAMINE HYDROCHLORIDE 6 [hp_X]/mL N 20181231 43742-0684_078d8421-a33a-401f-b583-4a4e8ae11e82 43742-0684 HUMAN OTC DRUG Bio Placenta Phase Aesculus Hippocastanum, Sarcolacticum Acidum, Secale Cornutum, Cuprum Sulphuricum, Melilotus Officinalis, Placenta Totalis Suis, Solanum Nigrum, Strophanthus Hispidus, Dhea (Dehydroepiandrosterone), Quercetin, Rutin, Natrum Pyruvicum, Vein (Suis), Arteria (Suis), Funiculus Umbilicalis Suis, Tabacum, Vipera Berus, Baryta Carbonica, Plumbum Iodatum, Astragalus Exscapus, Proteus (Vulgaris) LIQUID ORAL 20151210 20210113 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HORSE CHESTNUT; LACTIC ACID, L-; CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC SULFATE; MELILOTUS OFFICINALIS TOP; SUS SCROFA PLACENTA; SOLANUM NIGRUM WHOLE; STROPHANTHUS HISPIDUS SEED; PRASTERONE; QUERCETIN; RUTIN; SODIUM PYRUVATE; SUS SCROFA VEIN; SUS SCROFA ARTERY; SUS SCROFA UMBILICAL CORD; TOBACCO LEAF; VIPERA BERUS VENOM; BARIUM CARBONATE; LEAD IODIDE; ASTRAGALUS EXSCAPUS WHOLE FLOWERING/FRUITING; PROTEUS VULGARIS 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 10; 10; 10; 10; 13; 18; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0686_1349e3c9-5362-43bd-bdeb-dc94ac49cafb 43742-0686 HUMAN OTC DRUG hA2cg EVOLUTION Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Brain (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), AACG-A, AACG-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-KETO-DHEA (3- Acetyl-Oxo-Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (Suis), Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20151207 20201228 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; ANEMONE PULSATILLA 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0687_10993c61-2c50-4738-ae79-b524ae2c84d6 43742-0687 HUMAN OTC DRUG Bio Galium Phase Betula (Pendula), Cortex, Caltha Palustris, Clematis Erecta, Galium Aparine, Hedera Helix, Juniperus Communis, Sedum Acre, Sempervivum Tectorum, Thuja Occidentalis, Urtica Urens, Echinacea (Angustifolia), Nitricum Acidum, Cortisone Aceticum, Argentum Metallicum, Calcarea Fluorica, Phosphorus, Aurum Metallicum, Ononis Spinosa, Gaertner Bacillus (Bach) LIQUID ORAL 20151202 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETULA PENDULA BARK; CALTHA PALUSTRIS; CLEMATIS RECTA FLOWERING TOP; GALIUM APARINE; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; CORTISONE ACETATE; SILVER; CALCIUM FLUORIDE; PHOSPHORUS; GOLD; APIS MELLIFERA; ONONIS SPINOSA WHOLE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 5; 6; 6; 8; 8; 8; 10; 12; 5; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0688_93bf8086-bab5-4f97-8b33-05306ccb7c76 43742-0688 HUMAN OTC DRUG Hormone Combination Salsolinol Hydrochloride, Cholesterinum, DHEA (Dehydroepiandrosterone), 7-Keto-DHEA (3-Acetyl-7-Oxo-Dehydroepiandrosterone), Folliculinum, Oophorinum (Suis), Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone LIQUID ORAL 20151207 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SALSOLINOL HYDROCHLORIDE, (+/-)-; CHOLESTEROL; PRASTERONE; 7-KETO-DEHYDROEPIANDROSTERONE; ESTRONE; SUS SCROFA OVARY; PROGESTERONE; TESTOSTERONE; CORTISONE ACETATE; ALDOSTERONE; ANDROSTERONE; FOLLITROPIN 6; 6; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0689_4c49504e-edf4-4adf-8740-c69b55b1d79d 43742-0689 HUMAN OTC DRUG Detox III Conium Maculatum, Dulcamara, Echinacea, Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid, Coccus Cacti, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Pulsatilla, Sarcolacticum Acidum, Lymph (Suis), Sulphur, Glandula Suprarenalis Suis, Phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (Suis), Spleen (Suis), Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Funiculus Umbilicalis Suis, Tonsil (Suis), Gaertner Bach, Triiodothyronine LIQUID ORAL 20151207 20210706 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA ANGUSTIFOLIA; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; PULSATILLA VULGARIS; LACTIC ACID, L-; SUS SCROFA LYMPH; SULFUR; SUS SCROFA ADRENAL GLAND; PHENYLALANINE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA SPLEEN; CORTISONE ACETATE; MERCURIUS SOLUBILIS; BARIUM CARBONATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA TONSIL; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; LIOTHYRONINE; SUS SCROFA BONE MARROW; BISPHENOL A; BROMINE; CHLORINE; HYDROFLUORIC ACID; IODINE; ESCHERICHIA COLI 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 10; 10; 10; 10; 10; 13; 13; 28; 6; 6; 9; 10; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0690_52bc5639-e324-4c3a-9523-2d7bf4d1aaa8 43742-0690 HUMAN OTC DRUG Heart Small Intestine Meridian Formula Adrenlinum, Coumarinum, Tyramine, Arteria Suis, Ascorbic Acid, Cactus Grandiflorus, Coenzyme A, Glonoinum, Heart (Suis), Sarcolacticum Acidum, Ubidecarenonum, Vein (Suis), Adrenocorticotrophin, Arsenicum Album, Aurum Metallicum, Belladonna, Digitalis Purpurea, Kali Carbonicum, Lithium Carbonicum, Lycopodium Clavatum, Mercurius Solubilis, Naja Tripudians, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris), Spigelia Anthelmia, Dysentery Bacillus, Gaertner Bacillus LIQUID ORAL 20151208 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EPINEPHRINE; COUMARIN; TYRAMINE; SUS SCROFA ARTERY; ASCORBIC ACID; SELENICEREUS GRANDIFLORUS STEM; COENZYME A; NITROGLYCERIN; PORK HEART; LACTIC ACID, L-; UBIDECARENONE; SUS SCROFA VEIN; CORTICOTROPIN; ARSENIC TRIOXIDE; GOLD; ATROPA BELLADONNA; DIGITALIS; POTASSIUM CARBONATE; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SPIGELIA ANTHELMIA; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0691_d7399811-fb7d-4dd6-a27d-6dff40243d3e 43742-0691 HUMAN OTC DRUG Lung Large Intestine Meridian Formula Coumarinum, Phenyl Isothiocyanate, Intestine (Suis), Ascorbic Acid, Coenzyme A, Ubidecarenonum, Colon (Suis), Lung (Suis), Riboflavinum, Sarcolacticum Acidum, Aloe, Alumina, Apis Mellifica, Arsenicum Album, Baryta Carbonica, Bryonia (Alba), Carbo Vegetabilis, Chamomilla, Kali Bichromicum, Phosphorus, Plumbum Metallicum, Pyrogenium, Sulphur, Dysentery Bacillus, Gaertner Bacillus (Bach) LIQUID ORAL 20151208 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COUMARIN; PHENYL ISOTHIOCYANATE; PORK INTESTINE; ASCORBIC ACID; COENZYME A; SUS SCROFA COLON; SUS SCROFA LUNG; RIBOFLAVIN; LACTIC ACID, L-; UBIDECARENONE; ALOE; ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; POTASSIUM DICHROMATE; PHOSPHORUS; LEAD; RANCID BEEF; SULFUR; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 6; 6; 8; 6; 6; 6; 6; 6; 6; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0693_81e23bd8-4546-400b-af29-432c10c90666 43742-0693 HUMAN OTC DRUG PEMF Optimizer Aqua Sulis, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Lapis Albus, Manganum Metallicum Vanadium Metallicum Viscum Album, Zincum Metallicum LIQUID ORAL 20151208 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. WATER; SILVER; GOLD; COPPER; CALCIUM HEXAFLUOROSILICATE; MANGANESE; VANADIUM; VISCUM ALBUM FRUITING TOP; ZINC 30; 1; 1; 1; 1; 1; 1; 1; 1 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 43742-0694_79a1f441-4edc-49c0-910a-d89951d05d19 43742-0694 HUMAN OTC DRUG Bladder Kidney Meridian Opener Apis Mellifica, Argentum Nitricum, Berberis Vulgaris, Cantharis, Equisetum Arvense, Kali Bichromicum, Lycopodium Clavatum, Mercurius Solubilis, Natrum Muriaticum, Phosphorus, Rhus Tox, Sepia, Terebinthina, Thuja Occidentalis LIQUID ORAL 20151208 20210105 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; EQUISETUM ARVENSE TOP; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; TURPENTINE OIL; THUJA OCCIDENTALIS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0695_5dbac28d-55e4-4bfe-a0b6-00efec4a0e91 43742-0695 HUMAN OTC DRUG GABA GABA LIQUID ORAL 20151209 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. .GAMMA.-AMINOBUTYRIC ACID 6 [hp_X]/mL N 20181231 43742-0696_f5fad996-9c84-4a5e-91ac-4ed4130be29c 43742-0696 HUMAN OTC DRUG Histamine Histaminum Hydrochloricum LIQUID ORAL 20151209 UNAPPROVED HOMEOPATHIC Deseret Biologials, Inc. HISTAMINE DIHYDROCHLORIDE 6 [hp_X]/mL N 20181231 43742-0697_d900d3e5-e0b8-40ba-bbcd-f2db8dec4d02 43742-0697 HUMAN OTC DRUG L Dopa L-Dopa LIQUID ORAL 20151209 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LEVODOPA 6 [hp_X]/mL N 20181231 43742-0698_a85d64b9-76ca-4a6c-9020-de99a5c44950 43742-0698 HUMAN OTC DRUG Streptococcus Remedy Enterococcus Faecalis, Pneumococcinum, Streptococcus Viridans, Streptococcus Mutans LIQUID ORAL 20151209 20210105 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ENTEROCOCCUS FAECALIS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS VIRIDANS GROUP; STREPTOCOCCUS MUTANS 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0699_f9b7888d-9f39-41e4-ad9e-c2fb887daca5 43742-0699 HUMAN OTC DRUG Midrange Detox Core Formula Solidago Virgaurea, Baptisia Tinctoria, Berberis Vulgaris, Equisetum Hyemale, Argentum Nitricum, Cantharis, Capsicum Annuum, Cuprum Sulphuricum, Orthosiphon Stamineus, Pareira Brava, Sarsaparilla (Smilax Regelii), Terebinthina, Apis Venenum Purum, Barosma (Betulina), Mercurius Corrosivus, Pyelon (Suis), Ureter (Suis), Urethra (Suis), Urinary Bladder (Suis), Glyoxal Trimer Dihydrate, Hepar Sulphuris Calcareum, Natrum Pyruvicum, Quercetin, Colibacillinum Cum Natrum Muriaticum, Dysentery Bacillus LIQUID ORAL 20151230 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SOLIDAGO VIRGAUREA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; SILVER NITRATE; LYTTA VESICATORIA; CAPSICUM; CUPRIC SULFATE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; TURPENTINE OIL; APIS MELLIFERA VENOM; AGATHOSMA BETULINA LEAF; MERCURIC CHLORIDE; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; GLYOXAL TRIMER DIHYDRATE; CALCIUM SULFIDE; SODIUM PYRUVATE; QUERCETIN; ESCHERICHIA COLI; SHIGELLA DYSENTERIAE 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0700_686a667f-9479-4d59-98a5-0e92fb6856f8 43742-0700 HUMAN OTC DRUG Amoeba Baptisia Tinctoria, Cajuputum, Capsicum Annuum, Fragaria Vesca, Frasera Caroliniensis, Hamamelis Virginiana, Hydrastis Canadensis, Quassia (Amara), Senna (Cassia Angustifolia), Ipecacuanha, Hepar Suis, Pancreas Suis, Spleen (Suis), Belladonna, Cinchona Officinalis, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Selenium Metallicum Amoeba Axis, Blastocystis Hominis, Cryptosporidium Parvum, Giardia Lamblia, Brugia Malayi LIQUID ORAL 20151222 20210125 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BAPTISIA TINCTORIA ROOT; CAJUPUT OIL; CAPSICUM; ALPINE STRAWBERRY; FRASERA CAROLINIENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; GOLDENSEAL; QUASSIA AMARA WOOD; SENNA LEAF; IPECAC; PORK LIVER; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; SELENIUM; AMOEBA PROTEUS; BLASTOCYSTIS HOMINIS; CRYPTOSPORIDIUM PARVUM; GIARDIA LAMBLIA; BRUGIA MALAYI 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0701_8e27c8da-fb12-4631-874f-aa03839e49a6 43742-0701 HUMAN OTC DRUG B Complex Mix System Formula Magnesium Orotate, Beta Vulgaris, Ascorbic Acid, Citricum Acidum, Cysteinum, Pulsatilla (Vulgaris), Adenine, Amygdalin, Adenosinum Triphosphoricum Dinatrum, Cholinum, Cyanocobalamin, Folic Acid, Inositol, Niacin, p-Aminobenzoic Acid, Pangamic Acid, Pantothenic Acid, Pyridoxinum Hydrochloricum, Riboflavinum, Sulphur, Thiaminum Hydrochloricum, Natrum Oxalaceticum, Oroticum Acidum, Manganum Phosphoricum, Mutabile Bacillus (Bach), Morgan Bacillus (Pure) LIQUID ORAL 20151222 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MAGNESIUM OROTATE; BETA VULGARIS; ASCORBIC ACID; ANHYDROUS CITRIC ACID; CYSTEINE; PULSATILLA VULGARIS; ADENINE; AMYGDALIN; ADENOSINE TRIPHOSPHATE DISODIUM; CHOLINE HYDROXIDE; CYANOCOBALAMIN; FOLIC ACID; INOSITOL; NIACIN; AMINOBENZOIC ACID; PANGAMIC ACID; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SULFUR; THIAMINE HYDROCHLORIDE; SODIUM DIETHYL OXALACETATE; OROTIC ACID MONOHYDRATE; MANGANESE PHOSPHATE, DIBASIC; ESCHERICHIA COLI; PROTEUS MORGANII 12; 2; 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 8; 10; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0704_7ca1b88b-36df-44eb-b6a5-1e462f83e7f1 43742-0704 HUMAN OTC DRUG Metox Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Ascorbic Acid, Cysteinum, Methionine, Thyroidinum (Suis), Carbolicum Acidum, Formalinum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Carbolicum Acidum, Formalinum LIQUID ORAL 20160217 20210331 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GARLIC; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ASCORBIC ACID; CYSTEINE; METHIONINE; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE; CHROMIUM; COBALT; COPPER; IRON; IODINE; IRIDIUM; POTASSIUM CARBONATE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MOLYBDENUM; SODIUM CHLORIDE; PHOSPHORUS; SELENIUM; STRONTIUM CARBONATE; SULFUR; VANADIUM; ZINC; PHENOL; FORMALDEHYDE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; BORON; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BROMINE; CADMIUM; CERIUM; CESIUM; DYSPROSIUM; ERBIUM; EUROPIUM; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; MERCURIUS SOLUBILIS; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; TIN; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; YTTERBIUM OXIDE; LANTHANUM; NIOBIUM; TANTALUM 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 14; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0705_a1ef66d7-1182-48bd-9911-03cadc818b79 43742-0705 HUMAN OTC DRUG Prostate Petroselinum Sativum, Populus Tremuloides, Sabal Serrulata, Chimaphila Umbellata, Adenosinum Triphosphoricum Dinatrum, Equol, Kreosotum, Nadidum, Testosterone, Prostate (Suis), Succinicum Acidum, Hepar Sulphuris Calcareum, Conium Maculatum, Proteus (Mirabilis), Proteus (Vulgaris) LIQUID ORAL 20160217 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PETROSELINUM CRISPUM; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; SAW PALMETTO; CHIMAPHILA UMBELLATA; ADENOSINE TRIPHOSPHATE DISODIUM; EQUOL, (+/-)-; WOOD CREOSOTE; NADIDE; TESTOSTERONE; SUS SCROFA PROSTATE; SUCCINIC ACID; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; PROTEUS MIRABILIS; PROTEUS VULGARIS 4; 4; 4; 4; 5; 6; 6; 6; 6; 6; 8; 8; 10; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0712_3da76a0c-c1bf-4bc4-9f97-2c0271f71980 43742-0712 HUMAN OTC DRUG Acetaldehyde Acetaldehyde LIQUID ORAL 20160113 20210216 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETALDEHYDE 6 [hp_X]/mL N 20181231 43742-0715_7b5e0cd5-1311-42a1-a946-5a5071f88152 43742-0715 HUMAN OTC DRUG Matrix Support Ceanothus Americanus, Hydrastis Canadensis, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Momordica Balsamina, Oxalis Acetosella, Pulsatilla, Bile Duct (Suis), Colon (Suis), Duodenum (Suis), Esophagus (Suis), Eye (Suis), Gallbladder (Suis), Ileum (Suis), Intestine (Suis), Ipecacuanha, Jejunum (Suis), Kali Bichromicum, Lung (Suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (Suis), Pancreas Suis, Phosphorus, Rectum (Suis), Stomach (Suis), Sulphur, Mannan LIQUID ORAL 20160201 20210513 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PULSATILLA VULGARIS; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; ATROPA BELLADONNA; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 4; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0716_545d8b0b-a634-4513-9b94-26e3261fc1f8 43742-0716 HUMAN OTC DRUG Detox I Carduus Marianus, Chelidonium Majus, Cinchona Officinalis, Lycopodium Clavatum, Taraxacum Officinale, Veratrum Album, Avena Sativa, Cynara Scolymus, Methylcobalamin, Menadione, Alpha-Lipoicum Acidum, Hepar Suis, Colon (Suis), Duodenum (Suis), Gallbladder (Suis), Intestine (Suis), Lymph Node (Suis), Pancreas Suis, Thymus (Suis), Alpha-Ketoglutaricum Acidum, Cholesterinum, Formicum Acidum, Glyoxal Trimer Dihydrate, Histaminum Hydrochloricum, Malic Acid, Natrum Oxalaceticum, Sulphur LIQUID ORAL 20160222 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MILK THISTLE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT; AVENA SATIVA FLOWERING TOP; CYNARA SCOLYMUS LEAF; METHYLCOBALAMIN; MENADIONE; .ALPHA.-LIPOIC ACID; PORK LIVER; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; PORK INTESTINE; SUS SCROFA LYMPH; SUS SCROFA PANCREAS; SUS SCROFA THYMUS; .ALPHA.-KETOGLUTARIC ACID; CHOLESTEROL; FORMIC ACID; GLYOXAL TRIMER DIHYDRATE; HISTAMINE DIHYDROCHLORIDE; MALIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; OROTIC ACID MONOHYDRATE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII 3; 4; 4; 4; 4; 4; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 13; 28; 7; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0717_ff0799f5-f439-49f5-8289-5c201b1e5b38 43742-0717 HUMAN OTC DRUG Epstein-Barr Virus Remedy Epstein-Barr Virus Nosode LIQUID ORAL 20160216 20210419 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN HERPESVIRUS 4 15 [hp_X]/mL N 20181231 43742-0718_b55cf0d6-11d3-434e-a142-ad6cb103505f 43742-0718 HUMAN OTC DRUG Energize Sarcolacticum Acidum, Viscum Album, Iodium, Colchicum Autumnale, Conium Maculatum, Fucus Vesiculosus, Galium Aparine, Natrum Oxalaceticum, Thyroidinum (Suis), DHEA (Dehydroepiandrosterone), Phenyl Isothiocyanate, Tri-Iodothyronine, Tyramine, Alpha-Ketoglutaricum Acidum, Adenosinum Triphosphoricum Dinatrum, Fumaricum Acidum, Malic Acid, Funiculus Umbilicalis Suis, Hepar Suis, Medulla Ossis Suis, Pineal Gland (Suis), Spleen (Suis), Thymus (Suis), Calcarea Fluorica, Pulsatilla (Vulgaris) LIQUID ORAL 20160222 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LACTIC ACID, L-; VISCUM ALBUM FRUITING TOP; IODINE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; FUCUS VESICULOSUS; GALIUM APARINE; SODIUM DIETHYL OXALACETATE; THYROID, PORCINE; PRASTERONE; PHENYL ISOTHIOCYANATE; LIOTHYRONINE; TYRAMINE; .ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; FUMARIC ACID; MALIC ACID; SUS SCROFA UMBILICAL CORD; PORK LIVER; SUS SCROFA BONE MARROW; SUS SCROFA PINEAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; CALCIUM FLUORIDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; CORTISONE ACETATE; MERCURIC CHLORIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; ESCHERICHIA COLI 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 8; 8; 12; 12; 12; 30; 60; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0719_2d45e3af-bb5c-4bc8-9b69-b75c91da1ddd 43742-0719 HUMAN OTC DRUG Spine and Nerve Balance Core Formula Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Cuprum Aceticum, Nadidum, Natrum Oxalaceticum, Nicotinamidum, Picricum Acidum, Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, alpha-Lipoicum Acidum, Ammonium Muriaticum, Cartilago Suis, Discus Intervertebralis (Suis), Silicea, Argentum Metallicum, Calcarea Phosphorica, Coenzyme A, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, LIQUID ORAL 20160510 20210308 UNAPPROVED HOMEOPATHIC Deseret Biologicals Inc. BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; CUPRIC ACETATE; NADIDE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PICRIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; .ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; COENZYME A; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SUS SCROFA BONE MARROW; MERCURIC OXIDE; SULFUR; ENTEROBACTER CLOACAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII; PROTEUS VULGARIS 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 28; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0720_e828ba72-7c2e-4ad3-9348-824c233b3d06 43742-0720 HUMAN OTC DRUG Focus Adenosinum Triphosphoricum Dinatrum, Alpha-Ketoglutaricum Acidum, Formicum Acidum, Malic Acid, Sarcolacticum Acidum, Dulcamara, Hyoscyamus Niger, Phosphorus, Sabina, Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, GABA (Gamma-Aminobutyric Acid), Norepinephrine, Octopamine (Hydrochloride), Phenylethylamine (Hydrochloride), Serotonin (Hydrochloride), Taurine, Tyramine, Adenosinum Cyclophosphoricum, Brain Stem (Suis), Cerebrum (Suis), Pineal Gland (Suis), LIQUID ORAL 20160323 20210407 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; OXOGLURIC ACID; FORMIC ACID; MALIC ACID; LACTIC ACID, L-; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; PHOSPHORUS; JUNIPERUS SABINA LEAFY TWIG; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; DOPAMINE HYDROCHLORIDE; .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; OCTOPAMINE HYDROCHLORIDE; PHENETHYLAMINE HYDROCHLORIDE; SEROTONIN HYDROCHLORIDE; TAURINE; TYRAMINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA BRAINSTEM; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS; SILICON DIOXIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; SHIGELLA DYSENTERIAE; STRYCHNOS NUX-VOMICA SEED; LYCOSA TARANTULA; VALERIAN; VERATRUM ALBUM ROOT 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0721_ec1bd069-1c20-4d77-857e-d6916b7a2d8d 43742-0721 HUMAN OTC DRUG Perfect Sleep Adenosinum Triphosphoricum Dinatrum, Coenzyme A, Pineal Gland (Suis), Sarcolacticum Acidum, Ubidecarenonum, Melatonin, Pyrrole, Tryptophan, Arsenicum Album, Avena Sativa, Chamomilla, Coffea Cruda, Mercurius Corrosivus, Passiflora Incarnata, Silicea, Zincum Valerianicum, Dysentery Bacillus, Gaertner Bacillus (Bach) LIQUID ORAL 20160322 20210413 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; COENZYME A; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; UBIDECARENONE; MELATONIN; PYRROLE; TRYPTOPHAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE; ZINC VALERATE DIHYDRATE; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0722_ee9d1acc-7f85-46d7-b217-71f6cd66b1b9 43742-0722 HUMAN OTC DRUG Governing Vessel Conception Vessel Meridian Formula L-Phenylalanine, Taurine, Nerve (Suis), Adenosinum Triphosphoricum Dinatrum, Ascorbic Acid, Cerebrum (Suis), Sarcolacticum Acidum, Adrenocorticotrophin, Malvin, Apis Mellifica, Arsenicum Album, Baryta Carbonica, Belladonna, Calcarea Carbonica, Cicuta Virosa, Conium Maculatum, Ferrum Metallicum, Lachesis Mutus, Lycopodium Clavatum, Mercurius Solubilis, Natrum Sulphuricum, Phosphorus, Pulsatilla (Vulgaris), Sepia, Tarentula Hispana, Thuja Occidentalis, Dysentery Bacillus LIQUID ORAL 20160229 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHENYLALANINE; TAURINE; SUS SCROFA NERVE; ADENOSINE TRIPHOSPHATE DISODIUM; ASCORBIC ACID; SUS SCROFA CEREBRUM; LACTIC ACID, L-; CORTICOTROPIN; MALVIN; APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CICUTA VIROSA ROOT; CONIUM MACULATUM FLOWERING TOP; IRON; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; LYCOSA TARANTULA; THUJA OCCIDENTALIS LEAFY TWIG; SHIGELLA DYSENTERIAE 6; 6; 8; 6; 6; 6; 6; 8; 10; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0723_007b4236-55fd-4e19-909c-228ff0f267c8 43742-0723 HUMAN OTC DRUG Pertussis Aconitum Napellus, Antimonium Tartaricum, Belladonna, Bryonia (Alba), Hyoscyamus Niger, Ipecacuanha, Sticta Pulmonaria, Tabacum, Phosphorus, Kreosotum, Silicea, Pertussinum, Tetanus Toxin LIQUID ORAL 20160307 20210412 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; HYOSCYAMUS NIGER; IPECAC; LOBARIA PULMONARIA; TOBACCO LEAF; PHOSPHORUS; WOOD CREOSOTE; SILICON DIOXIDE; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; CLOSTRIDIUM TETANI 4; 4; 4; 4; 4; 4; 4; 4; 5; 6; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0724_4bfb87d6-b9e0-47ae-939d-da65652a02a8 43742-0724 HUMAN OTC DRUG Energize Sarcolacticum Acidum, Viscum Album, Iodium, Colchicum Autumnale, Conium Maculatum, Fucus Vesiculosus, Galium Aparine, Thyroidinum (Suis), DHEA (Dehydroepiandrosterone), Phenyl Isothiocyanate, Tyramine, Adenosinum Triphosphoricum Dinatrum, Alpha-Ketoglutaricum Acidum, Fumaricum Acidum, Malic Acidum, Natrum Oxalaceticum, Funiculus Umbilicalis Suis, Hepar Suis, Medulla Ossis Suis, Pineal Gland (Suis), Spleen (Suis), Thymus (Suis), Calcarea Fluorica, Pulsatilla (Vulgaris), Spongia Tosta, Cortisone Aceticum TABLET ORAL 20160503 UNAPPROVED HOMEOPATHIC Deseret Biologicals LACTIC ACID, L-; VISCUM ALBUM FRUITING TOP; IODINE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; FUCUS VESICULOSUS; GALIUM APARINE; SUS SCROFA THYROID; PRASTERONE; PHENYL ISOTHIOCYANATE; TYRAMINE; ADENOSINE TRIPHOSPHATE DISODIUM; OXOGLURIC ACID; FUMARIC ACID; MALIC ACID; SODIUM DIETHYL OXALACETATE; SUS SCROFA UMBILICAL CORD; PORK LIVER; SUS SCROFA BONE MARROW; SUS SCROFA PINEAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; CALCIUM FLUORIDE; ANEMONE PULSATILLA; SPONGIA OFFICINALIS SKELETON, ROASTED; CORTISONE ACETATE; MERCURIC CHLORIDE; LIOTHYRONINE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; ESCHERICHIA COLI 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 30; 60; 15; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 43742-0725_6ea27cfa-65b9-4578-8f8a-d75dc9409265 43742-0725 HUMAN OTC DRUG Enviro I Potassium Gluconate, Glandula Suprarenalis Suis, Hepar Suis, Bamboo, Barley, California Poppy, Corn, Flax, Levant Cotton, Millet, Milo, Avena Sativa, Oryza Sativa, Rye, Safflower, Sesame, Sorghum, Soy Bean, Sugarcane, Sunflower, Wheat, Coffea Tosta, Thea Sinensis, Carbo Vegetabilis, Ferrum Iodatum, Ferrum Metallicum, Gelsemium Sempervirens, Iodium, Iridium Metallicum, Lycopodium Clavatum, Pulsatilla (Vulgaris), Selenium Metallicum, Zincum Metallicum, Allium Cepa, Amygdale Amara, LIQUID ORAL 20160330 20210403 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. POTASSIUM GLUCONATE; SUS SCROFA ADRENAL GLAND; PORK LIVER; BAMBUSA VULGARIS LEAF; BARLEY; ESCHSCHOLZIA CALIFORNICA; CORN; FLAX SEED; GOSSYPIUM HERBACEUM ROOT BARK; MILLET; AVENA SATIVA FLOWERING TOP; ORYZA SATIVA WHOLE; RYE; SAFFLOWER; SESAME SEED; SORGHUM BICOLOR WHOLE; HELIANTHUS ANNUUS FLOWERING TOP; WHEAT; COFFEA ARABICA SEED, ROASTED; GREEN TEA LEAF; ACTIVATED CHARCOAL; FERROUS IODIDE; IRON; GELSEMIUM SEMPERVIRENS ROOT; IODINE; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SELENIUM; ZINC; ONION; ALMOND; CASHEW; PEANUT; BEEF; BRAZIL NUT; PECAN; CASEIN, STREPTOCOCCUS THERMOPHILUS CULTURED, PROPIONIBACTERIUM FREUDENREICHII SUBSP. SHERMANII CULTURED, AGED; CHICKEN BREAST; ORANGE; COCONUT; PACIFIC COD; EGG; FRAGARIA VESCA FRUIT; BLACK WALNUT; ENGLISH WALNUT; COW MILK; LAMB; LIMULUS POLYPHEMUS; TOMATO; APPLE; BANANA; OYSTER, UNSPECIFIED; BEAN; BLACK PEPPER; PORK; SALMON, UNSPECIFIED; SHRIMP, UNSPECIFIED; EGGPLANT; POTATO; TUNA, UNSPECIFIED; CORTISONE ACETATE; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; SEROTONIN HYDROCHLORIDE; COCOA 6; 8; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 10; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0726_acd87d25-e16f-4667-9038-0f9efe14cd1f 43742-0726 HUMAN OTC DRUG Elevate Lycopodium Clavatum, Natrum Muriaticum, Sepia, Belladonna, Causticum, Phosphorus, Sulphur, 5-Hydroxytryptophan, Alumina, Silicea, Acetylcholine Chloride, Dopamine Hydrochloride, Norepinephrine, Phenylethylamine, Serotonin (Hydrochloride), Adenosinum Cyclophosphoricum, Cerebrum (Suis), Diencephalon (Suis), Funiculus Umbilicalis Suis, Pantothenic Acid, Pineal Gland (Suis), Sarcolacticum Acidum, Faecalis Bach, Gaertner Bacillus (Bach), Proteus (Vulgaris) LIQUID ORAL 20160420 20211011 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SEPIA OFFICINALIS JUICE; ATROPA BELLADONNA; CAUSTICUM; PHOSPHORUS; SULFUR; OXITRIPTAN; ALUMINUM OXIDE; SILICON DIOXIDE; ACETYLCHOLINE CHLORIDE; DOPAMINE HYDROCHLORIDE; NOREPINEPHRINE; PHENETHYLAMINE; SEROTONIN HYDROCHLORIDE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA UMBILICAL CORD; PANTOTHENIC ACID; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; ALCALIGENES FAECALIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS VULGARIS 3; 3; 3; 4; 4; 4; 4; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0727_10fe33a2-f1e9-40bd-afda-16efb69ee7df 43742-0727 HUMAN PRESCRIPTION DRUG Perfect Sleep Adenosinum Triphosphoricum Dinatrum, Pantothenic Acid, Ubidecarenonum, Pineal Gland (Suis), Sarcolacticum Acidum, Melatonin, Pyrrole, Tryptophan, Arsenicum Album, Avena Sativa, Chamomilla, Coffea Cruda, Mercurius Corrosivus, Passiflora Incarnata, Silicea, Zincum Valerianicum, Dysentery Bacillus, Gaertner Bacillus TABLET ORAL 20160420 20210510 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; PANTOTHENIC ACID; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; UBIDECARENONE; MELATONIN; PYRROLE; TRYPTOPHAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE; ZINC VALERATE DIHYDRATE; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1 Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 43742-0728_cf174ac2-231d-4c9d-b710-980ec7a87ce3 43742-0728 HUMAN OTC DRUG Epinephrine Adrenalinum LIQUID ORAL 20160412 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EPINEPHRINE 6 [hp_X]/mL N 20181231 43742-0729_81d25e28-eb71-436d-b060-dde435d1904f 43742-0729 HUMAN OTC DRUG Perfect Sleep Adenosinum Triphosphoricum Dinatrum, Pantothenic Acid, Pineal Gland (Suis), Sarcolacticum Acidum, Ubidecarenonum, Melatonin, Pyrrole, Tryptophan, Arsenicum Album, Avena Sativa, Chamomilla, Coffea Cruda, Mercurius Corrosivus, Passiflora Incarnata, Silicea, Zincum Valerianicum, Dysentery Bacillus, Gaertner Bacillus (Bach) LIQUID ORAL 20160412 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE PHOSPHATE DISODIUM; PANTOTHENIC ACID; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; UBIDECARENONE; MELATONIN; PYRROLE; TRYPTOPHAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE; ZINC VALERATE DIHYDRATE; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0730_2146fd8a-eb46-44dd-a78a-edae9305406a 43742-0730 HUMAN OTC DRUG Rheumatism Benzoicum Acidum, Pulsatilla (Vulgaris), Rhododendron Chrysanthum, Spiraea Ulmaria, Aconitum Napellus, Dulcamara, Euphorbium Officinarum, Ledum Palustre, Asclepias Tuberose, Lithium Benzoicum LIQUID ORAL 20160421 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BENZOIC ACID; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; FILIPENDULA ULMARIA ROOT; ACONITUM NAPELLUS; SOLANUM DULCAMARA TOP; EUPHORBIA RESINIFERA RESIN; LEDUM PALUSTRE TWIG; ASCLEPIAS TUBEROSA ROOT; LITHIUM BENZOATE 3; 3; 3; 3; 4; 4; 4; 4; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0731_22063a5c-b8a3-40d9-97fd-00768d5d1b0a 43742-0731 HUMAN OTC DRUG Herpes Simplex Remedy Herpes Simplex I, Herpes Simplex II LIQUID ORAL 20160421 20210510 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2 15; 15 [hp_X]/mL; [hp_X]/mL N 20181231 43742-0732_557b2a32-1812-432a-8fef-01294510b90f 43742-0732 HUMAN OTC DRUG Adrenal Support Aralia Quinquefolia, Humulus Lupulus, Adrenalinum, Cortisone Aceticum, Thyroidinum (Suis), Selenium Metallicum, Arsenicum Album, Calcarea Carbonica, Convallaria Majalis, Crotalus Horridus, Ferrum Metallicum, Nux Vomica, Phosphorus, Sepia, Phosphoricum Acidum LIQUID ORAL 20160421 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMERICAN GINSENG; HOPS; EPINEPHRINE; CORTISONE ACETATE; THYROID, PORCINE; SELENIUM; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; IRON; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE; PHOSPHORIC ACID 3; 3; 6; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0733_c45d31e1-cfd5-4316-af5e-c97b66f0597d 43742-0733 HUMAN OTC DRUG Focus Adenosinum Triphosphoricum Dinatrum, Alpha-Ketoglutaricum Acidum, Formicum Acidum, Malicum Acidum, Sarcolacticum Acid, Dulcamara, Hyoscyamus Niger, Phosphorus, Sabina, Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, GABA(Gamma-Aminobutyric Acid), Norepinephrine, Octopamine (Hydrochloride), Phenylethylamine (Hydrochloride), Serotonin (Hydrochloride), Taurine, Tyramine, Adenosinum Cyclophosphoricum, Brain Stem (Suis), Cerebrum Suis, Diencephalon (Suis), Pineal Gland (Suis) LIQUID ORAL 20160422 UNAPPROVED HOMEOPATHIC Desert Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; OXOGLURIC ACID; FORMIC ACID; MALIC ACID; LACTIC ACID, L-; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; PHOSPHORUS; JUNIPERUS SABINA LEAFY TWIG; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; DOPAMINE HYDROCHLORIDE; .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; OCTOPAMINE HYDROCHLORIDE; PHENETHYLAMINE HYDROCHLORIDE; SEROTONIN HYDROCHLORIDE; TAURINE; TYRAMINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA BRAINSTEM; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; SILICON DIOXIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; SHIGELLA DYSENTERIAE; STRYCHNOS NUX-VOMICA SEED; LYCOSA TARANTULA; VALERIAN; VERATRUM ALBUM ROOT 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0734_5a70bb95-ef18-4828-b6b0-e2f73d9ee029 43742-0734 HUMAN OTC DRUG Glucagon Glucagon LIQUID ORAL 20160413 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GLUCAGON 8 [hp_X]/mL N 20181231 43742-0735_03755c3f-9c5a-492e-9bea-7069e18f76e7 43742-0735 HUMAN OTC DRUG Menadione Menadione LIQUID ORAL 20170320 UNAPPROVED HOMEOPATHIC Deseret Biologicals MENADIONE 6 [hp_X]/mL N 20181231 43742-0736_2aa3434c-01b8-4283-aafc-2e85abc82369 43742-0736 HUMAN OTC DRUG Virus Plus Influenzinum (2015-2016), Adenoviren Nosode, Herpes Simplex 1 Nosode, Herpes Simplex 2 Nosode, Cytomegalovirus Nosode, Epstein-Barr Virus Nosode, Hepatitis B Nosode, Norovirus Nosode LIQUID ORAL 20160422 20210601 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); HUMAN ADENOVIRUS E SEROTYPE 4; HUMAN ADENOVIRUS B SEROTYPE 7; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4; HEPATITIS B VIRUS; NORWALK VIRUS 12; 12; 12; 12; 12; 12; 15; 15; 15; 15; 18; 18; 33; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0737_fdbd8d59-316c-4e34-8b2b-4b7e3f6b265a 43742-0737 HUMAN OTC DRUG Sore Throat Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinals, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla (Smilax Regelii), Calcarea Phosphorica, Ferrum Iodatum, Lymph Node (Suis), Thyroidinum (Suis) LIQUID ORAL 20160422 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; ARANEUS DIADEMATUS; SMILAX REGELII ROOT; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA LYMPH; THYROID, PORCINE 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 5; 5; 5; 6; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0739_99963c09-29cd-4923-89a3-26f0b8a09d3e 43742-0739 HUMAN OTC DRUG Reflux Acetyl Coenzyme A, Adenosinum Triphosphoricum Dinatrum, Nadidum, Coumarinum, Argentum Nitricum, Ipecacuanha, Robinia Pseudoacacia, Sulphur, Nux Vomica, Origanum Vulgare, Duodenum (Suis), Esophagus (Suis), Funiculus Umbilicalis Suis, Stomach (Suis), Erythraea Centaurium, Pepsinum, Muriaticum Acidum, Citricum Acidum, Formicum Acidum, Sarcolacticum Acidum, Proteus (Morgani) LIQUID ORAL 20160428 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYL COENZYME A; ADENOSINE TRIPHOSPHATE DISODIUM; NADIDE; COUMARIN; SILVER NITRATE; IPECAC; ROBINIA PSEUDOACACIA BARK; SULFUR; STRYCHNOS NUX-VOMICA SEED; OREGANO; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA UMBILICAL CORD; SUS SCROFA STOMACH; CENTAURIUM ERYTHRAEA; PEPSIN; HYDROCHLORIC ACID; ANHYDROUS CITRIC ACID; FORMIC ACID; LACTIC ACID, L-; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 10; 12; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0740_0d9c458c-12c9-47c3-99fd-368d8e2a279a 43742-0740 HUMAN OTC DRUG Heart Small Intestine Arsenicum Album, Aurum Metallicum, Belladonna, Cactus Grandiflorus, Cinchona Officinalis, Digitalis Purpurea, Kali Carbonicum, Lithium Carbonicum, Lycopodium Clavatum, Mercurius Solubilis, Naja Tripudians, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris), Pyrogenium, Spigelia Anthelmia LIQUID ORAL 20160422 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; GOLD; ATROPA BELLADONNA; SELENICEREUS GRANDIFLORUS STEM; CINCHONA OFFICINALIS BARK; DIGITALIS; POTASSIUM CARBONATE; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; SPIGELIA ANTHELMIA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0741_15f8f98f-09c9-46f7-9d99-7e083418b7a7 43742-0741 HUMAN OTC DRUG Female Stimulant Aquilegia Vulgaris, Lilium Tigrinum, Bovista, Cypripedium Pubescens, Hydrastis Canadensis, Apiolum, Apis Venenum Purum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Heart (Suis), Kreosotum, Oophorinum (Suis), Uterus (Suis), Folliculinum, Aconiticum Acidum, Cis-, Lachesis Mutus, Magnesia Phosphorica, Mercurius Solubilis, Sepia, Pineal Gland (Suis), Hypophysis Suis, Estradiol, Progesterone, Testosterone, Placenta Totalis Suis, Bacillus Faecalis, Mutabile Bacillus (Bach) LIQUID ORAL 20160428 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AQUILEGIA VULGARIS; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPERDON UTRIFORME FRUITING BODY; CYPRIPEDIUM PARVIFOLUM ROOT; GOLDENSEAL; PARSLEY; APIS MELLIFERA VENOM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK HEART; WOOD CREOSOTE; SUS SCROFA OVARY; SUS SCROFA UTERUS; ESTRONE; ACONITIC ACID, (Z)-; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; SEPIA OFFICINALIS JUICE; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; ESTRADIOL; PROGESTERONE; TESTOSTERONE; SUS SCROFA PLACENTA; ALCALIGENES FAECALIS; ESCHERICHIA COLI 4; 4; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 12; 13; 30; 30; 30; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0742_b793105e-29f4-4d9a-9c6c-0984394cea8a 43742-0742 HUMAN OTC DRUG Gallbladder Liver Meridian Formula Cholesterinum, Histaminum Hydrochloricum, Menadione, Pyrrole, Alpha-Lipoicum Acidum, Ascorbic Acid, Adenosinum Triphosphoricum Dinatrum, Fel Tauri, Gallbladder (suis), Hepar Suis, Sarcolacticum Acidum, Adrenocorticotrophin, Arsencium Album, Belladonna, Berberis Vulgaris, Bryonia (alba), Calcarea Carbonica, Carduus Marianus, Cinchona Officinalis, Colocynthis, Kali Carbonicum, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus, Sepia, Morgan Gaertner LIQUID ORAL 20160427 UNAPPROVED HOMEOPATHIC Deseret Biologicals CHOLESTEROL; HISTAMINE DIHYDROCHLORIDE; MENADIONE; PYRROLE; .ALPHA.-LIPOIC ACID; ASCORBIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; BOS TAURUS BILE; SUS SCROFA GALLBLADDER; PORK LIVER; LACTIC ACID, L-; CORTICOTROPIN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILYBUM MARIANUM SEED; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0743_261ed9e2-4580-41f7-9744-d885f5e8bac3 43742-0743 HUMAN OTC DRUG FNG Berberis Vulgaris, Cochlearia Armoracia, Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Tabebuia Impetiginosa, Hydrastis Canadensis, Propolis, Formalinum, Glandula Suprarenalis Suis, Thymus (Suis), Ferrum Metallicum, Iridium Metallicum, Lycopodium Clavatum, Phosphoricum Acidum, Pulsatilla (Vulgaris), Selenium Metallicum, Zincum Metallicum, Adenosinum Triphosphoricum Dinatrum, Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus LIQUID ORAL 20160503 20210608 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; HORSERADISH; ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; MYRRH; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; PROPOLIS WAX; FORMALDEHYDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; IRON; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PULSATILLA VULGARIS; SELENIUM; ZINC; ADENOSINE TRIPHOSPHATE DISODIUM; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; METHYLCOBALAMIN; LACTIC ACID, L-; STACHYBOTRYS CHARTARUM; ESCHERICHIA COLI; BRUGIA MALAYI 3; 3; 3; 3; 3; 3; 6; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0744_d180d8ad-5d16-4d3c-a826-f5925e4129db 43742-0744 HUMAN OTC DRUG Inflammation II Asafoetida, Kalmia Latifolia, Causticum, Colchicum Autumnale, Ferrum Metallicum, Gnaphalium Polycephalum, Lithium Benzoicum, Mercurius Praecipitatus Ruber, Rhus Tox, Spiraea Ulmaria LIQUID ORAL 20160504 20210618 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASAFETIDA; KALMIA LATIFOLIA LEAF; CAUSTICUM; COLCHICUM AUTUMNALE BULB; IRON; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LITHIUM BENZOATE; MERCURIC OXIDE; TOXICODENDRON PUBESCENS LEAF; FILIPENDULA ULMARIA ROOT 8; 8; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0745_e4031432-8615-4ecd-93cb-d700f7a2744a 43742-0745 HUMAN OTC DRUG Sulphur Remedy Sulphur, Asclepias Tuberosa, Bryonia, Dulcamara LIQUID ORAL 20160504 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SULFUR; ASCLEPIAS TUBEROSA ROOT; BRYONIA ALBA ROOT; SOLANUM DULCAMARA STEM 4; 6; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0746_b68dc27e-5851-43b0-8198-876d96e107f6 43742-0746 HUMAN OTC DRUG Female Support Chamomilla, Cimicifuga Racemosa, Cinchona Officinalis, Convallaria Majalis, Crocus Sativus, Helonias Dioica, Hydrastis Canadensis, Mentha Piperita, Senna (Cassia Angustifolia), Valeriana Officinalis, Viola Odorata, Agnus Castus, Ledum Palustre, Lilium Tigrinum, Staphysagria, Cyclamen Europaeum, Cinnamomum, Murex Purpurea, Naja Tripudians LIQUID ORAL 20160505 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MATRICARIA RECUTITA; BLACK COHOSH; CINCHONA OFFICINALIS BARK; SAFFRON; CHAMAELIRIUM LUTEUM ROOT; MENTHA PIPERITA; SENNA LEAF; VALERIAN; VIOLA ODORATA; CHASTE TREE; CONVALLARIA MAJALIS; LEDUM PALUSTRE TWIG; LILIUM LANCIFOLIUM WHOLE FLOWERING; DELPHINIUM STAPHISAGRIA SEED; CYCLAMEN PURPURASCENS TUBER; GOLDENSEAL; CINNAMON; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; NAJA NAJA VENOM 3; 3; 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 6; 6; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0747_bc00c6e2-bc74-40be-964e-217db4386511 43742-0747 HUMAN OTC DRUG HGH Vitality Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-Dopa, Melatonin, Testosterone, Adenosinum Triphosphoricum Dinatrum, Alpha-Lipoicum Acidum, Nadidum, Pantothenic Acid, Sarcolacticum Acidum, Ubidecarenonum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (Suis), Lymph Node (Suis), Medulla Ossis Suis, Oophorinum (Suis), Orchitinum (Suis), Pancreas Suis, Spleen (Suis), Human Growth Hormone TABLET ORAL 20160505 20210711 UNAPPROVED HOMEOPATHIC Deseret Biologicals CHASTE TREE; AMBERGRIS; CONIUM MACULATUM FLOWERING TOP; APIOLE (PARSLEY); ESTRADIOL; ESTRIOL; ESTRONE; LEVODOPA; MELATONIN; TESTOSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; .ALPHA.-LIPOIC ACID; NADIDE; PANTOTHENIC ACID; LACTIC ACID, L-; UBIDECARENONE; BARIUM CARBONATE; SELENIUM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SOMATROPIN; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 N 20181231 43742-0752_46f89737-76a3-424b-b283-d2561447c7a5 43742-0752 HUMAN OTC DRUG Metox Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Ascorbic Acid, Cysteinum, L-Methionine, Thyroidinum (Suis), Carbolicum Acidum, Formalinum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Carbolicum Acidum, Formalinum LIQUID ORAL 20160506 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GARLIC; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ASCORBIC ACID; CYSTEINE; METHIONINE; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE; CHROMIUM; COBALT; COPPER; IRON; IODINE; IRIDIUM; POTASSIUM CARBONATE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MOLYBDENUM; SODIUM CHLORIDE; PHOSPHORUS; SELENIUM; STRONTIUM CARBONATE; SULFUR; VANADIUM; ZINC; PHENOL; FORMALDEHYDE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; BORON; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; DYSPROSIUM; ERBIUM; EUROPIUM; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; MERCURIUS SOLUBILIS; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; TIN; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; YTTERBIUM OXIDE; LANTHANUM; NIOBIUM; TANTALUM 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 14; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0753_2f79b6cb-9dcd-4b70-b895-db8dbd224862 43742-0753 HUMAN OTC DRUG Adrenal Support Aralia Quinquefolia, Humulus Lupulus, Adrenalinum, Cortisone Aceticum, Thyroidinum (Suis), Selenium Metallicum, Arsenicum Album, Calcarea Carbonica, Convallaria Majalis, Crotalus Horridus, Ferrum Metallicum, Nux Vomica, Phosphorus, Sepia, Phosphoricum Acidum LIQUID ORAL 20160506 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMERICAN GINSENG; HOPS; EPINEPHRINE; CORTISONE ACETATE; SUS SCROFA THYROID; SELENIUM; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; IRON; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE; PHOSPHORIC ACID 3; 3; 6; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0754_72554917-da4e-4f51-8bcf-39695536dca2 43742-0754 HUMAN OTC DRUG Coumarin Coumarinum LIQUID ORAL 20160506 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COUMARIN 6 [hp_X]/mL N 20181231 43742-0755_08cd76d2-64ec-4488-a130-8e54e23cc6c8 43742-0755 HUMAN OTC DRUG HGH Vitality Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-Dopa, Melatonin, Testosterone, Adenosinum Triphosphoricum Dinatrum, Alpha-Lipoicum Acidum, Nadidum, Pantothenic Acid, Sarcolacticum Acidum, Ubidecarenonum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (Suis), Lymph Node (Suis), Medulla Ossis Suis, Oophorinum (Suis), Orchitinum (Suis), Pancreas Suis, Spleen (Suis), Human Growth Hormone LIQUID ORAL 20160606 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHASTE TREE; AMBERGRIS; CONIUM MACULATUM FLOWERING TOP; APIOLE (PARSLEY); ESTRADIOL; ESTRIOL; ESTRONE; LEVODOPA; MELATONIN; TESTOSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; .ALPHA.-LIPOIC ACID; NADIDE; PANTOTHENIC ACID; LACTIC ACID, L-; UBIDECARENONE; BARIUM CARBONATE; SELENIUM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SOMATROPIN; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0756_736175c0-58e9-4767-b1d8-4da7cd591006 43742-0756 HUMAN OTC DRUG Energy Catalyst Viscum Album, Cobalt Gluconate, Cuprum Sulphuricum, Ferrous Fumarate, Magnesium Aspartate, Manganese Gluconate, Phosphorus, Potassium Aspartate, Sodium Molybdate, Adenosinum, Cyclophosphoricum, Cerium Oxalicum, Nickel Acetate, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Dysprosium Metallicum, Erbium Metallicum LIQUID ORAL 20160602 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. VISCUM ALBUM FRUITING TOP; COBALTOUS GLUCONATE; CUPRIC SULFATE; FERROUS FUMARATE; MAGNESIUM ASPARTATE; MANGANESE GLUCONATE; PHOSPHORUS; POTASSIUM ASPARTATE; SODIUM MOLYBDATE; ADENOSINE CYCLIC PHOSPHATE; CEROUS OXALATE NONAHYDRATE; NICKEL ACETATE; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; DYSPROSIUM; ERBIUM; EUROPIUM; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; TIN; TERBIUM; THALLIUM; URANIUM; YTTERBIUM OXIDE; CHOLECALCIFEROL; TRIBASIC CALCIUM PHOSPHATE; CHROMIUM; COBALT; COPPER; IRON; IODINE; IRIDIUM; POTASSIUM CARBONATE; LITHIUM; MAGNESIUM; MANGANESE; MOLYBDENUM; SODIUM CHLORIDE; SELENIUM; STRONTIUM; SULFUR; VANADIUM; ZINC; ALUMINUM OXIDE; MERCURIC CHLORIDE; ARSENIC TRIOXIDE; MERCURIUS SOLUBILIS; LEAD; LANTHANUM; NIOBIUM; TANTALUM; PROTEUS MORGANII 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 1000; 1000; 1000; 14; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0757_69e7fa04-6795-4e6b-bae0-0419d2d14145 43742-0757 HUMAN OTC DRUG Spinalmax Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Cuprum Aceticum, Nadidum, Natrum Oxalaceticum, Nicotinamidum, Picricum Acidum, Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Alpha-Lipoicum Acidum, Ammonium Muriaticum, Cartilago Suis, Discus Intervertebralis (Suis), Silicea, Argentum Metallicum, Calcarea Phosphorica, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Gnaphalium Polycephalum LIQUID ORAL 20160531 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; CUPRIC ACETATE; NADIDE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PICRIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; THIOCTIC ACID; AMMONIUM CHLORIDE; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SUS SCROFA BONE MARROW; MERCURIC OXIDE; PANTOTHENIC ACID; SULFUR; ENTEROBACTER CLOACAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII; PROTEUS VULGARIS 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 28; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0758_a818ff95-c09f-4aea-a339-098982f09adb 43742-0758 HUMAN OTC DRUG Amoeba Baptisia Tinctoria, Cajuputum, Capsicum Annuum, Fragaria Vesca, Frasera Caroliniensis, Hamamelis Virginiana, Quassia (Amara), Senna (Cassia Angustifolia), Hydrastis Canadensis, Ipecacuanha, Hepar Suis, Pancreas Suis, Spleen (Suis), Belladonna, Cinchona Officinalis, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Selenium Metallicum, Amoeba Axis, Blastocystis Hominis, Cryptosporidium Parvum, Giardia Lamblia, Brugia Malayi LIQUID ORAL 20160601 20210620 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BAPTISIA TINCTORIA ROOT; CAJUPUT OIL; CAPSICUM; ALPINE STRAWBERRY; FRASERA CAROLINIENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; QUASSIA AMARA WOOD; SENNA LEAF; GOLDENSEAL; IPECAC; PORK LIVER; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; SELENIUM; ENTAMOEBA HISTOLYTICA; BLASTOCYSTIS HOMINIS; CRYPTOSPORIDIUM PARVUM; GIARDIA LAMBLIA; BRUGIA MALAYI 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0759_e5832923-6e59-4ae1-bf98-939efced9a35 43742-0759 HUMAN OTC DRUG Candida Plus Echinacea (Angustifolia), Phytolacca Decandra, Hydrastis Canadensis, Acetaldehyde, Caffeic Acid, Gallicum Acidum, Indolum, Mannan, Lycopodium Clavatum, Mercurius Solubilis, Pulsatilla (Vulgaris), Sepia, Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Pullularia Pullulans, Rhizopus Nigricans, Torula Cerevisiae, Candida Albicans, Brugia Malayi LIQUID ORAL 20160606 20210623 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; ACETALDEHYDE; CAFFEIC ACID; GALLIC ACID MONOHYDRATE; INDOLE; YEAST MANNAN; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; BRUGIA MALAYI 3; 3; 6; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0760_ca63bbd1-fa8d-41dd-8b3e-f2d6743954f1 43742-0760 HUMAN OTC DRUG Neuro I Taraxacum Officinale, Hydrastis Canadensis, Dopamine (Hydrochloride), L-Dopa, Melatonin, Serotonin (Hydrochloride) LIQUID ORAL 20160531 20210620 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GOLDENSEAL; TARAXACUM OFFICINALE; DOPAMINE HYDROCHLORIDE; LEVODOPA; MELATONIN; SEROTONIN HYDROCHLORIDE 3; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0761_fb6d57bf-0f31-4ae3-b525-85216967d87c 43742-0761 HUMAN OTC DRUG Kidney Drainage Solidago Virgaurea, Asparagus Officinalis, Juniperus Communis, Sabal Serrulata, Uva Ursi, Berberis Vulgaris, Equisetum Arvense, Rhus Aromatica, Urtica Dioica, Cantharis, Rubia Tinctorum, Staphysagria, Cobaltum Metallicum, Fagus Sylvatica Flos, Glandula Suprarenalis Suis, Hepar Sulphuris Calcareum, Kidney (Suis), Larix Decidua Flos, Manganum Metallicum, Mimulus Guttatus Flos, Nitricum Acidum, Silicea, Ulex Europaeus Flos, Benzoicum Acidum LIQUID ORAL 20160606 20210718 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SOLIDAGO VIRGAUREA FLOWERING TOP; ASPARAGUS; JUNIPERUS COMMUNIS WHOLE; SAW PALMETTO; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; EQUISETUM ARVENSE TOP; RHUS AROMATICA ROOT BARK; URTICA DIOICA; LYTTA VESICATORIA; RUBIA TINCTORUM ROOT; DELPHINIUM STAPHISAGRIA SEED; COBALT; FAGUS SYLVATICA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; CALCIUM SULFIDE; PORK KIDNEY; LARIX DECIDUA FLOWERING TOP; MANGANESE; MIMULUS GUTTATUS FLOWERING TOP; NITRIC ACID; SILICON DIOXIDE; ULEX EUROPAEUS FLOWER; BENZOIC ACID 1; 2; 2; 2; 2; 3; 3; 3; 3; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0762_beb851b7-522c-4a4e-8466-33ad7bce6f20 43742-0762 HUMAN OTC DRUG Progesterone Progesterone LIQUID ORAL 20160606 20210629 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PROGESTERONE 6 [hp_X]/mL N 20181231 43742-0763_d9295790-401f-4ec4-bda6-c91c6acbb3c8 43742-0763 HUMAN OTC DRUG Mycoplasma Remedy Mycoplasma Pneumoniae LIQUID ORAL 20160606 20210706 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MYCOPLASMA PNEUMONIAE 15 [hp_X]/mL N 20181231 43742-0764_5a3c65d6-295f-4c0c-9e34-fb2be5bfa60d 43742-0764 HUMAN OTC DRUG Caffeic Acid Caffeic Acid LIQUID ORAL 20160607 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CAFFEIC ACID 6 [hp_X]/mL N 20181231 43742-0765_9c0ed52a-a078-428c-8962-0d13ffcae97e 43742-0765 HUMAN OTC DRUG Bio Mood Phase Cortisone Aceticum, Adrenalinum, Chininum Arsenicosum, Helonias Dioica, Hypericum Perforatum, Kali Phosphoricum, Nux Vomica, Selenium Metallicum, Aurum Metallicum, Bacillus 7 (Enterobacter Cloacae) LIQUID ORAL 20160607 20210722 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CORTISONE ACETATE; EPINEPHRINE; QUININE ARSENATE; CHAMAELIRIUM LUTEUM ROOT; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SELENIUM; GOLD; ENTEROBACTER CLOACAE 6; 6; 10; 10; 10; 10; 10; 10; 10; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0766_c704a556-5d03-40e5-b6ef-13837d81f7c2 43742-0766 HUMAN OTC DRUG EBV CFS Plus Baptisia Tinctoria, Condurango, Echinacea (Angustifolia), Ligusticum Porteri, Nasturtium Aquaticum, Phytolacca Decandra, Tabebuia Impetiginosa, Astragalus Menziesii, Hydrastis Canadensis, Propolis, Glandula Suprarenalis Suis, Thymus (Suis), Aranea Diadema, Gelsemium Sempervirens, Ipecacuanha, Lycopodium Clavatum, Mercurius Solubilis, Muriaticum Acidum, Nitricum Acidum, Rhus Tox, Selenium Metallicum, Silicea, Epstein-Barr Virus Nosode LIQUID ORAL 20160607 20210705 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BAPTISIA TINCTORIA ROOT; MARSDENIA CONDURANGO BARK; ECHINACEA ANGUSTIFOLIA; LIGUSTICUM PORTERI ROOT; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; TABEBUIA IMPETIGINOSA BARK; ASTRAGALUS NUTTALLII LEAF; GOLDENSEAL; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; ARANEUS DIADEMATUS; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; HYDROCHLORIC ACID; NITRIC ACID; TOXICODENDRON PUBESCENS LEAF; SELENIUM; SILICON DIOXIDE; HUMAN HERPESVIRUS 4 3; 3; 3; 3; 3; 3; 3; 6; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0767_4777dd1a-8ef8-4ca5-a9db-1634f4e6c2a0 43742-0767 HUMAN OTC DRUG ENT Support Pulsatilla (Vulgaris), Euphorbium Officinarum, Luffa Operculata, Mercurius Iodatus Ruber, Argentum Nitricum, Hepar Sulphuris Calcareum, Influenzinum (2015-2016), Sinusitisinum, Aspergillus Niger, Candida Albicans, Gallicum Acidum, Mucor Racemosus, Mutabile Bacillus (Bach) LIQUID ORAL 20160607 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PULSATILLA VULGARIS; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SILVER NITRATE; CALCIUM SULFIDE; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); SINUSITISINUM; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; GALLIC ACID MONOHYDRATE; MUCOR RACEMOSUS; ESCHERICHIA COLI 2; 6; 6; 8; 10; 10; 11; 11; 11; 11; 11; 11; 17; 10; 10; 10; 10; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0769_c122ebbd-2df7-4f89-a5cf-f55139d76a7d 43742-0769 HUMAN OTC DRUG Insect Bite Hypericum Perforatum, Ledum Palustre, Latrodectus Mactans, Tarentula Cubensis, Tarentula Hispana, Lachesis Mutus, Lycopus Virginicus, Theridion, Cimex Lectularius, Formica Rufa, Pulex Irritans, Vespa Crabro, Loxosceles Reclusa LIQUID ORAL 20160607 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LATRODECTUS MACTANS; CITHARACANTHUS SPINICRUS; LYCOSA TARANTULA; LACHESIS MUTA VENOM; LYCOPUS VIRGINICUS; THERIDION CURASSAVICUM; CIMEX LECTULARIUS; FORMICA RUFA; PULEX IRRITANS; VESPA CRABRO; LOXOSCELES RECLUSA 3; 4; 8; 8; 8; 10; 12; 12; 15; 15; 15; 15; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0770_7936968e-de1a-41e6-9427-0ca99018ed19 43742-0770 HUMAN OTC DRUG Tryptophan Tryptophan LIQUID ORAL 20160608 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TRYPTOPHAN 6 [hp_X]/mL N 20181231 43742-0771_981563a9-8070-4fe0-b69d-e01d08e8b402 43742-0771 HUMAN OTC DRUG Melatonin Melatonin LIQUID ORAL 20160608 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MELATONIN 6 [hp_X]/mL N 20181231 43742-0772_0c060817-9990-4074-93af-53552a3122f8 43742-0772 HUMAN OTC DRUG Male Stimulant Aralia Quinquefolia, Agnus Castus, Ascorbicum Acidum, Caladium Seguinum, Kali Bromatum, Strychninum Phosphoricum, Cantharis, Damiana, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hypophysis Suis, Orchitinum (Suis), Prostate (Suis), Conium Maculatum, Diencephalon (Suis), Heart (Suis), Ferrum Phosphoricum, Magnesia Phosphorica, Selenium Metallicum, Zincum Metallicum, Pineal Gland (Suis), Cortisone Aceticum, Manganum Phosphoricum, Lycopodium Clavatum, Testosterone, Morgan Gaertner LIQUID ORAL 20160608 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMERICAN GINSENG; CHASTE TREE; ASCORBIC ACID; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; STRYCHNINE PHOSPHATE DIHYDRATE; LYTTA VESICATORIA; TURNERA DIFFUSA LEAFY TWIG; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA TESTICLE; SUS SCROFA PROSTATE; CONIUM MACULATUM FLOWERING TOP; SUS SCROFA DIENCEPHALON; PORK HEART; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SELENIUM; ZINC; SUS SCROFA PINEAL GLAND; CORTISONE ACETATE; MANGANESE PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; TESTOSTERONE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 12; 13; 20; 28; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0773_36848964-c9b5-4801-92b3-63f36781c0e6 43742-0773 HUMAN OTC DRUG Systemic Detox Beta Vulgaris, Boldo, Chelidonium Majus, Sarsaparilla (Smilax Regelii), Gelsemium Sempervirens, Veratrum Album, Ferrum Metallicum, Iodium, Lycopodium Clavatum, Nux Vomica, Pulsatilla (Vulgaris), Selenium Metallicum, Thuja Occidentalis, Zincum Metallicum LIQUID ORAL 20160608 20210722 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; SMILAX REGELII ROOT; GELSEMIUM SEMPERVIRENS ROOT; VERATRUM ALBUM ROOT; IRON; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SELENIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 3; 3; 3; 6; 7; 7; 12; 12; 12; 12; 12; 12; 12; 125 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0774_c8e031d3-cef8-4966-a43e-00ab0aec0d7e 43742-0774 HUMAN OTC DRUG Formaldehyde Formalinum LIQUID ORAL 20170322 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. FORMALDEHYDE 6 [hp_X]/mL N 20181231 43742-0775_1e80af64-4c91-442c-b013-3d17b1094a48 43742-0775 HUMAN OTC DRUG Oratox Fucus Vesiculosus, Lymph Node (Suis), Medulla Ossis Suis, Thymus (Suis), Thyroidinum (Suis), Calcarea Muriatica, Iodium, Natrum Fluoratum, Natrum Muriaticum, Selenium Metallicum, Vanadium Metallicum, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Eugenia Caryophyllata, Formalinum, Lidocaine, Mercurius Solubilis, Molybdenum Metallicum, Niccolum Metallicum, Palladium Metallicum, Stannum Metallicum, Titanium Metallicum, Zincum Metallicum LIQUID ORAL 20160614 20210714 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. FUCUS VESICULOSUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA THYMUS; SUS SCROFA THYROID; CALCIUM CHLORIDE; IODINE; SODIUM FLUORIDE; SODIUM CHLORIDE; SELENIUM; VANADIUM; SILVER; GOLD; COPPER; EUGENOL; FORMALDEHYDE; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; TIN; TITANIUM; ZINC 3; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0776_2afeb9c0-b7a1-4db9-ad6a-b20b9aaa4a2d 43742-0776 HUMAN OTC DRUG Lyme Plus Arnica Montana, Calendula Officinalis, Echinacea (Angustifolia), Myrrha, Phytolacca Decandra, Taraxacum Officinale, Trifolium Pratense, Trigonella Foenum-Graecum, Urtica Dioica, Hydrastis Canadensis, Propolis, Adrenalinum, Gunpowder, Thymus (Suis), Thyroidinum (Suis), Arsenicum Album, Cocculus Indicus, Iridium Metallicum, Lycopodium Clavatum, Phosphorus, Rhus Tox, Babesia Microti, Borrelia Burgdorferi Nosode, Ehrlichia Nosode (Canine), Encephalitis Nosode, Ledum Palustre, Meningococcus Nosode LIQUID ORAL 20160614 20210709 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; MYRRH; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; FENUGREEK SEED; URTICA DIOICA; GOLDENSEAL; PROPOLIS WAX; EPINEPHRINE; ACTIVATED CHARCOAL; SULFUR; POTASSIUM NITRATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; ARSENIC TRIOXIDE; ANAMIRTA COCCULUS SEED; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; BABESIA MICROTI; BORRELIA BURGDORFERI; EHRLICHIA CANIS; JAPANESE ENCEPHALITIS VIRUS; LEDUM PALUSTRE TWIG; NEISSERIA MENINGITIDIS; HEPATITIS B VIRUS 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 15; 15; 15; 15; 30; 30; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0777_1d31f4e2-90db-4243-be8f-98797f8a21a5 43742-0777 HUMAN OTC DRUG Enviroclenz Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Stillingia Sylvatica, Taraxacum Officinale, Trifolium Pratense, Germanium Sesquioxide, Benzinum, Chlorinum, Acetone, Ammonium Muriaticum, Propylene Glycol, Sodium Benzene Sulfonate, Sodium Lauryl Sulfate, Sodium Tripolyphosphate, Terebinthina, Methanol, Belladonna, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20160609 20210718 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; STILLINGIA SYLVATICA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; GERMANIUM SESQUIOXIDE; BENZENE; CHLORINE; ACETONE; AMMONIUM CHLORIDE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; TURPENTINE OIL; METHYL ALCOHOL; ATROPA BELLADONNA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0778_8205e371-a170-4aa3-92b8-48e0c9a4e61f 43742-0778 HUMAN OTC DRUG Neuro II Taraxacum Officinale, Hydrastis Canadensis, Acetylcholine Chloride, Adrenalinum, GABA (Gamma-Aminobutyric Acid), Histaminum Hydrochloricum, Norepinephrine, Tyramine LIQUID ORAL 20160609 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TARAXACUM OFFICINALE; GOLDENSEAL; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE DIHYDROCHLORIDE; NOREPINEPHRINE; TYRAMINE 3; 6; 6; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0779_9f812d79-6910-4403-bbe4-20f2cd1f220e 43742-0779 HUMAN OTC DRUG HA2CG Evolution Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Cerebrum Suis, Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), AACG-A, AACG-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-KETO (3-Acetyl-7-Oxo-Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (Suis), Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20160609 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; SUS SCROFA CEREBRUM; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0780_343b2695-3d24-4467-a426-004b3dbd6b36 43742-0780 HUMAN OTC DRUG Enviro I Potassium Gluconate, Glandula Suprarenalis Suis, Hepar Suis, Bamboo, Barley, California Poppy, Corn, Flax, Levant Cotton, Millet, Milo, Avena Sativa, Oryza Sativa, Rye, Safflower, Sesame, Sorghum, Soy Bean, Sugarcane, Sunflower, Wheat, Coffea Tosta, Thea Sinensis, Carbo Vegetabilis, Ferrum Iodatum, Ferrum Metallicum, Gelsemium Sempervirens, Iodium, Iridium Metallicum, Lycopodium Clavatum, Pulsatilla (Vulgaris), Selenium Metallicum, Zincum Metallicum, Allium Cepa, Amygdala Amara, LIQUID ORAL 20160628 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. POTASSIUM GLUCONATE; SUS SCROFA ADRENAL GLAND; PORK LIVER; BAMBUSA VULGARIS LEAF; BARLEY; POPPY SEED; CORN; FLAX SEED; COTTON SEED; MILLET; SORGHUM; AVENA SATIVA FLOWERING TOP; ORYZA SATIVA WHOLE; RYE; SAFFLOWER; SESAME SEED; SOYBEAN; SUGARCANE; HELIANTHUS ANNUUS FLOWERING TOP; WHEAT; COFFEA ARABICA SEED, ROASTED; GREEN TEA LEAF; ACTIVATED CHARCOAL; FERROUS IODIDE; IRON; GELSEMIUM SEMPERVIRENS ROOT; IODINE; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; ANEMONE PULSATILLA; SELENIUM; ZINC; ONION; ALMOND; CASHEW; PEANUT; BEEF; BRAZIL NUT; PECAN; CASEIN, STREPTOCOCCUS THERMOPHILUS CULTURED, PROPIONIBACTERIUM FREUDENREICHII SUBSP. SHERMANII CULTURED, AGED; CHICKEN BREAST; ORANGE; COCONUT; PACIFIC COD; EGG; FRAGARIA VESCA FRUIT; BLACK WALNUT; ENGLISH WALNUT; COW MILK; LAMB; LIMULUS POLYPHEMUS; TOMATO; APPLE; BANANA; OYSTER, UNSPECIFIED; KIDNEY BEAN; BLACK PEPPER; PORK; SALMON, UNSPECIFIED; SHRIMP, UNSPECIFIED; EGGPLANT; POTATO; TUNA, UNSPECIFIED; CORTISONE ACETATE; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; SEROTONIN HYDROCHLORIDE; COCOA 6; 8; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 10; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0781_8d30a205-b40c-4c2d-829f-e78db943f1f3 43742-0781 HUMAN OTC DRUG Apiol Apiolum LIQUID ORAL 20160629 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIOLE (PARSLEY) 6 [hp_X]/mL N 20181231 43742-0782_47afa7c1-753f-4015-8d80-39833a461f32 43742-0782 HUMAN OTC DRUG Bartonella Remedy Bartonella Bacilliformis ,Bartonella Clarridgeiae, Bartonella Elizabethae, Bartonella Henselae, Bartonella Quintana, Bartonella Vinsonii, Bartonella Washoensis LIQUID ORAL 20160627 20210803 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BARTONELLA BACILLIFORMIS; BARTONELLA CLARRIDGEIAE; BARTONELLA ELIZABETHAE; BARTONELLA HENSELAE; BARTONELLA QUINTANA; BARTONELLA VINSONII; BARTONELLA WASHOENSIS 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0783_817cbad3-d118-4572-b20b-1ba4bedba396 43742-0783 HUMAN OTC DRUG Multiple Miasm Arsenicum Album, Lycopodium Clavatum, Sulphur, Aloe, Carcinosin, Nitricum Acidum, Silicea, Thuja Occidentalis LIQUID ORAL 20160627 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; SULFUR; ALOE; HUMAN BREAST TUMOR CELL; NITRIC ACID; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0784_018d1da4-463d-45cb-bccb-f50afcd8fa09 43742-0784 HUMAN OTC DRUG Immune Support Echinacea (Angustifolia), Aconitum Napellus, Arnica Montana, Baptisia Tinctoria, Rhus Tox, Sanguinaria Canadensis, Aristolochia Clematitis, Bryonia (Alba), Eupatorium Perfoliatum, Euphorbium Officinarum, Gelsemium Sempervirens, Mercurius Corrosivus, Phytolacca Decandra, Argentum Nitricum, Arsenicum Album, Phosphorus, Pulsatilla (Vulgaris), Sulphur, Thuja Occidentalis, Hepar Sulphuris Calcareum, Lachesis Mutus, Zincum Metallicum, Astragalus Menziesii, Belladonna, Influenzinum (2015-2016), Spleen (Suis), LIQUID ORAL 20160630 20210804 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; ACONITUM NAPELLUS; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; ARISTOLOCHIA CLEMATITIS ROOT; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; MERCURIC CHLORIDE; PHYTOLACCA AMERICANA ROOT; SILVER NITRATE; ARSENIC TRIOXIDE; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; CALCIUM SULFIDE; LACHESIS MUTA VENOM; ZINC; ASTRAGALUS NUTTALLII LEAF; ATROPA BELLADONNA WHOLE; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); SUS SCROFA SPLEEN; SUS SCROFA THYMUS; VISCUM ALBUM FRUITING TOP; CORTISONE ACETATE; RANCID BEEF 2; 3; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 13; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0785_e464c5e3-68a0-43a0-85df-a263486cdcbd 43742-0785 HUMAN OTC DRUG Glucoreg Ascorbicum Acidum, Pyridoxinum Hydrochloricum, Riboflavinum, Sarcolacticum Acidum, Thiaminum Hydrochloricum, Acetaldehyde, DHEA (Dehydroepiandrosterone), Phloridzinum, Adenosinum Triphosphoricum Dinatrum, alpha-Lipoicum Acidum, Citricum Acidum, Fumaricum Acidum, Glyoxal Trimer Dihydrate, Nadidum, Pantothenic Acid, Insulinum (Suis), Hepar Suis, Pancreas Suis, Glucagon, Baryta Oxalica, Alloxanum, Berberis Vulgaris, Carcinosin, Lycopodium Clavatum, Momordica Balsamina, Phosphoricum Acidum, Phosphorus, LIQUID ORAL 20160712 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASCORBIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; LACTIC ACID, L-; THIAMINE HYDROCHLORIDE; ACETALDEHYDE; PRASTERONE; PHLORIZIN; ADENOSINE TRIPHOSPHATE DISODIUM; THIOCTIC ACID; CITRIC ACID MONOHYDRATE; FUMARIC ACID; GLYOXAL TRIMER DIHYDRATE; NADIDE; PANTOTHENIC ACID; INSULIN PORK; PORK LIVER; SUS SCROFA PANCREAS; GLUCAGON; BARIUM OXALATE; ALLOXAN; BERBERIS VULGARIS ROOT BARK; HUMAN BREAST TUMOR CELL; LYCOPODIUM CLAVATUM SPORE; MOMORDICA BALSAMINA IMMATURE FRUIT; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; GYMNEMA SYLVESTRE LEAF; TRIGONELLA FOENUM-GRAECUM WHOLE 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0786_806b1a33-37e4-4f77-9de6-05b6da014783 43742-0786 HUMAN OTC DRUG Grain and Soy Allergen Mix Adenosinum Triphosphoricum Dinatrum, Coumarinum, Quercetin, Rutin, Ileum (Suis), Jejunum (Suis) Stomach (Suis), Bacillus Thuringiensis (BT Toxin), Bamboo, Barley, Poppy Seed, Corn, Flax Seed, Cotton Seed, Millet, Milo, Oat, Rice, Rye, Safflower, Sesame, Sorghum, Soy Bean, Sugarcane, Sunflower, Wheat, Gluten, Amaranth, Avena Sativa, Natrum Sulphuricum, Sarcolacticum Acidum, Triticum Repens, Adrenocorticotrophin, Glyphosate, Sycotic Co Bacillus LIQUID ORAL 20160707 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; COUMARIN; QUERCETIN; RUTIN; SUS SCROFA ILEUM; SUS SCROFA JEJUNUM; SUS SCROFA STOMACH; BACILLUS THURINGIENSIS; BAMBUSA VULGARIS LEAF; BARLEY; POPPY SEED; CORN; FLAX SEED; LEVANT COTTON SEED; MILLET; SORGHUM BICOLOR WHOLE; OAT; BROWN RICE; RYE; SAFFLOWER; SESAME SEED; SORGHUM; SOYBEAN; SUGARCANE; SUNFLOWER SEED; WHEAT; WHEAT GLUTEN; AMARANTH; AVENA SATIVA FLOWERING TOP; SODIUM SULFATE; LACTIC ACID, L-; ELYMUS REPENS ROOT; CORTICOTROPIN; GLYPHOSATE; ENTEROCOCCUS FAECALIS 4; 6; 6; 6; 8; 8; 8; 8; 9; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 30; 6; 6; 6; 6; 6; 8; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0787_faaf02c2-b6bd-422c-89a4-f568cf500f3e 43742-0787 HUMAN OTC DRUG Metab Ascorbic Acid, Cysteinum, Manganese Gluconate, alpha-Ketoglutaricum Acidum, Fumaricum Acidum, Germanium Sesquioxide, Iodium, Magnesium Metallicum, Natrum Oxalaceticum, Pulsatilla (Vulgaris), Thyroidinum (Suis), Vanadium Metallicum LIQUID ORAL 20160627 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc ASCORBIC ACID; CYSTEINE; MANGANESE GLUCONATE; OXOGLURIC ACID; FUMARIC ACID; GERMANIUM SESQUIOXIDE; IODINE; MAGNESIUM; SODIUM DIETHYL OXALACETATE; ANEMONE PULSATILLA; SUS SCROFA THYROID; VANADIUM 6; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0789_46effde9-3e55-4161-bc14-e15b4b88552e 43742-0789 HUMAN OTC DRUG Matrix Support Ceanothus Americanus, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Hydrastis Canadensis, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (Vulgaris), Bile Duct (Suis), Colon (Suis), Duodenum (Suis), Esophagus (Suis), Eye (Suis), Gallbladder (Suis), Ileum (Suis), Intestine (Suis), Ipecacuanha, Jejunum (Suis), Kali Bichromicum, Lung, (Suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (Suis), Pancreas Suis, Phosphorus, Rectal Mucosa (Suis), Stomach (Suis LIQUID ORAL 20160707 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CEANOTHUS AMERICANUS LEAF; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; GOLDENSEAL; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PULSATILLA VULGARIS; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; ATROPA BELLADONNA; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0790_2ee440fe-5190-4d80-8199-d32d35850474 43742-0790 HUMAN OTC DRUG Inflammation Arnica Montana, Benzoicum Acidum, Echinacea (Angustifolia), Mercurialis Perennis, Apis Mellifica, Baptisia Tinctoria, Bryonia (Alba), Colchicum Autumnale, Dulcamara, Eucalyptus Globulus, Solanum Nigrum, Eupatorium Perfoliatum, Rhus Tox LIQUID ORAL 20160630 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; BENZOIC ACID; ECHINACEA ANGUSTIFOLIA; MERCURIALIS PERENNIS; APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; EUCALYPTUS GLOBULUS LEAF; SOLANUM NIGRUM WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0791_8e6fbc9b-c08b-4f8c-9c73-d69cbcaf4002 43742-0791 HUMAN OTC DRUG Streptococcus Series Therapy Kit Enterococcinum Nosode, Pneumococcinum, Streptococcus Viridans KIT 20160527 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. N 20181231 43742-0802_e3135d6f-3cc0-4223-8158-d0dd2aefe471 43742-0802 HUMAN OTC DRUG H Pylori Remedy Helicobacter Pylori LIQUID ORAL 20160706 20210804 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HELICOBACTER PYLORI 15 [hp_X]/mL N 20181231 43742-0803_5a71e1eb-4532-4f13-bdac-34b5c1835ffe 43742-0803 HUMAN OTC DRUG Eye Sarcode Eye (Suis) LIQUID ORAL 20160706 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SUS SCROFA EYE 30 [hp_C]/mL N 20181231 43742-0804_61130d2d-1727-439a-b269-d1f42133c0aa 43742-0804 HUMAN OTC DRUG Gallbladder Liver Meridian Opener Arsenicum Album, Berberis Vulgaris, Bryonia, Calcarea Carbonica, Carduus Marianus, Cinchona Officinalis, Kali Carbonicum, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus LIQUID ORAL 20160701 20210802 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILYBUM MARIANUM SEED; CINCHONA OFFICINALIS BARK; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0805_4093e919-da52-4211-895d-99f0e52b2261 43742-0805 HUMAN OTC DRUG Kidney Bladder Support Equisetum Hyemale, Solidago Virgaurea, Cantharis, Kidney (Suis), Belladonna, Berberis Vulgaris, Calcarea Carbonica, Terebinthina, Apis Mellifica, Pulsatilla (Vulgaris), Sepia, Staphysagria LIQUID ORAL 20160705 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EQUISETUM HYEMALE; SOLIDAGO VIRGAUREA FLOWERING TOP; LYTTA VESICATORIA; PORK KIDNEY; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TURPENTINE OIL; APIS MELLIFERA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED 3; 3; 6; 8; 12; 12; 12; 12; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0806_a6e37592-f341-4ece-aa9d-365e45c6b557 43742-0806 HUMAN OTC DRUG Circulation Cactus Grandiflorus, Kali Carbonicum, Kalmia Latifolia, Arnica Montana, Glonoinum, Ignatia Amara, Lacticum Acidum, Ranunculus Bulbosus, Alpha-Ketoglutaricum Acidum, Arsenicum Album, Fumaricum Acidum, Heart (Suis), Hepar Suis, Malicum Acidum, Natrum Oxalaceticum, Phosphorus, Strophanthus Hispidus, Spigelia Anthelmia, Carbo Vegetabilis, Naja Tripudians, Cytomegalovirus Nosode, Epstein-Barr Virus Nosode LIQUID ORAL 20160705 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SELENICEREUS GRANDIFLORUS STEM; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; ARNICA MONTANA; NITROGLYCERIN; STRYCHNOS IGNATII SEED; LACTIC ACID; RANUNCULUS BULBOSUS; OXOGLURIC ACID; ARSENIC TRIOXIDE; FUMARIC ACID; PORK HEART; PORK LIVER; MALIC ACID; SODIUM DIETHYL OXALACETATE; PHOSPHORUS; STROPHANTHUS HISPIDUS SEED; SPIGELIA ANTHELMIA; ACTIVATED CHARCOAL; NAJA NAJA VENOM; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4 3; 4; 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 12; 15; 17; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0807_7e36f279-059f-4aee-b130-aa68c0742a71 43742-0807 HUMAN OTC DRUG Virus Plus Influenzinum (2015-2016), Adenoviren Nosode, Herpes Simplex 1, Herpes Simplex 2, Cytomegalovirus Nosode, Epstein-Barr Virus Nosode, Hepatitis B Nosode, Norovirus Nosode LIQUID ORAL 20160705 20210809 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ANTIGEN; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4; HEPATITIS B VIRUS; NORWALK VIRUS 12; 12; 12; 12; 12; 12; 15; 15; 15; 15; 15; 18; 33; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0808_f804d9af-867c-4d44-91c8-7b7faa5cae9b 43742-0808 HUMAN PRESCRIPTION DRUG EMF Protect and Balance Alfalfa, Laminaria Digitata, Symphytum Officinale, Ascorbic Acid, Melatonin, Calcarea Carbonica, Cuprum Metallicum, Ferrum Metallicum, Iodium, Manganum Aceticum, Silicea, Phosphorus, Magnetis Polus Arcticus, Magnetis Polus Australis, X-Ray, Agate, Quartz, Carbon Dioxide, Aconitum Napellus, Arsenicum Album, Gaertner Bacillus (Bach), Kali Carbonicum LIQUID ORAL 20160712 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALFALFA; LAMINARIA DIGITATA; COMFREY ROOT; ASCORBIC ACID; MELATONIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COPPER; IRON; IODINE; MANGANESE ACETATE TETRAHYDRATE; SILICON DIOXIDE; PHOSPHORUS; ALCOHOL, X-RAY EXPOSED (1000 RAD); CARBON DIOXIDE; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; POTASSIUM CARBONATE 3; 3; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC],Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 43742-0809_0400d225-1ec3-4917-96c4-529a4d9a7024 43742-0809 HUMAN OTC DRUG Nerve Z Condurango, Echinacea (Angustifolia), Ginkgo Biloba, Ligusticum Porteri, Myrrha, Phytolacca Decandra, Tabebuia Impetiginosa, Hydrastis Canadensis, Propolis, Glandula Suprarenalis Suis, Spleen (Suis), Thymus (Suis), Thyroidinum (Suis), Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Selenium Metallicum, Pyrogenium LIQUID ORAL 20160712 20211027 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MARSDENIA CONDURANGO BARK; ECHINACEA ANGUSTIFOLIA; GINKGO; LIGUSTICUM PORTERI ROOT; MYRRH; PHYTOLACCA AMERICANA FRUIT; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SUS SCROFA THYROID; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SELENIUM; RANCID BEEF 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0810_4d7775e4-a896-4555-bd77-17f34c8deb99 43742-0810 HUMAN OTC DRUG Breathe Aconitum Napellus, Argentum Nitricum, Arsenicum Album, Natrum Muriaticum, Rhus Tox, Sulphur, Adenosinum Cyclophosphoricum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Lung (Suis), Mucosa Nasalis Suis, Pantothenic Acid, Sarcolacticum Acidum, Acetylcholine Chloride, Coumarinum, Malvin, Dysentery Bacillus, Proteus (Morgani) LIQUID ORAL 20160713 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF; SULFUR; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; PANTOTHENIC ACID; LACTIC ACID, L-; ACETYLCHOLINE CHLORIDE; COUMARIN; MALVIN; SHIGELLA DYSENTERIAE; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 6; 6; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0811_3abcc5a3-c035-4083-9282-23f465a2b181 43742-0811 HUMAN OTC DRUG Lung Large Intestine Meridian Opener Aloe, Alumina, Apis Mellifica, Arsenicum Album, Baryta Carbonica, Bryonia (Alba), Carbo Vegetabilis, Chamomilla, Kali Bichromicum, Phosphorus, Plumbum Metallicum, Pyrogenium, Sulphur LIQUID ORAL 20160713 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc ALOE VERA LEAF; ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; POTASSIUM DICHROMATE; PHOSPHORUS; LEAD; RANCID BEEF; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [kp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; 1/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0812_082075eb-3fbe-401e-bc23-5cca7fd2b72e 43742-0812 HUMAN OTC DRUG Asthma Plus Ribes Nigrum, Viburnum Opulus, Quebracho, Arsenicum Iodatum, Blatta Orientalis, Naphthalinum, Pothos Foetidus, Cinnamic Acid, Coumarinum, Gallicum Acidum, Indolum, Quercetin, Rutin, Dust Mite Allersode, Oxygenium, Malvin LIQUID ORAL 20160713 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. RIBES NIGRUM LEAF; VIBURNUM OPULUS BARK; QUEBRACHO BARK; ARSENIC TRIIODIDE; BLATTA ORIENTALIS; NAPHTHALENE; SYMPLOCARPUS FOETIDUS ROOT; CINNAMIC ACID; COUMARIN; GALLIC ACID; INDOLE; QUERCETIN; RUTIN; DERMATOPHAGOIDES FARINAE; OXYGEN; MALVIN 3; 3; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 9; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0813_faf366dd-882c-4aab-a254-afc95015fd5d 43742-0813 HUMAN OTC DRUG Streptococcus Homochord Enterococcus Faecalis, Pheumococcinum, Streptococcus Viridans, Streptococcus Mutans LIQUID ORAL 20160726 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ENTEROCOCCUS FAECALIS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS VIRIDANS GROUP; STREPTOCOCCUS MUTANS 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0814_13956ef9-c805-4b12-8ac4-867abe48dd7a 43742-0814 HUMAN OTC DRUG Candida Albicans Homochord Candida Albicans LIQUID ORAL 20160719 20210816 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CANDIDA ALBICANS 15 [hp_X]/mL N 20181231 43742-0815_cf229d2f-2e38-4b74-a6f9-d5e49acdf28e 43742-0815 HUMAN OTC DRUG Chemtox Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Glandula Suprarenalis Suis, Hepar Suis, Lymph Node (Suis), Thyroidinum (Suis), Belladonna, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum, Selenium Metallicum, Salicylicum Acidum, Adrenocorticotrophin, Cortisone Aceticum, Eugenol, Stearyl Alcohol, Xylitol, Folliculinum, Benzoicum Acidum, Chlorinum, Potassium Sorbate, Sorbitol, Resorcinum LIQUID ORAL 20160721 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA LYMPH; SUS SCROFA THYROID; ATROPA BELLADONNA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; SELENIUM; SALICYLIC ACID; CORTICOTROPIN; CORTISONE ACETATE; EUGENOL; STEARYL ALCOHOL; XYLITOL; ESTRONE; BENZOIC ACID; CHLORINE; POTASSIUM SORBATE; SORBITOL; RESORCINOL; BENZYL ALCOHOL; LACTIC ACID; ISOPROPYL PALMITATE; BORIC ACID; ACETIC ACID; PHENYLBUTAZONE; PETROLATUM; LEAD 3; 3; 3; 3; 3; 3; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0816_b0ee07fb-112f-4107-ad30-d2a1ac13d268 43742-0816 HUMAN OTC DRUG Upper Respiratory Staph Strep Combination Staphylococcus Aureus, Klebsiella Pheumoniae, Enterococcus Faecalis, Pneumococcinum, Streptococcus Agalactiae, Streptococcus Mutans, Haemophilus Influenzae B, Streptococcus Viridans LIQUID ORAL 20160721 20210824 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. STAPHYLOCOCCUS AUREUS; KLEBSIELLA PNEUMONIAE; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS MUTANS; HAEMOPHILUS INFLUENZAE TYPE B; STREPTOCOCCUS VIRIDANS GROUP 15; 15; 12; 12; 12; 12; 12; 36 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; s/mL; 1/mL N 20181231 43742-0817_fa2cfd77-dfe3-4a1e-985b-a2bfa45d4547 43742-0817 HUMAN OTC DRUG Acetylcholine Chloride Acetylcholine Chloride LIQUID ORAL 20160721 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETYLCHOLINE CHLORIDE 6 [hp_X]/mL N 20181231 43742-0818_b16ef5e1-f02f-4851-b70c-cc9b41576a39 43742-0818 HUMAN OTC DRUG Indole Indolum LIQUID ORAL 20160721 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. INDOLE 6 [hp_X]/mL N 20181231 43742-0819_5af84914-1416-4d4c-8500-d9963feac76a 43742-0819 HUMAN OTC DRUG Vascuflow Cholesterinum, Formalinum, Gelsemium Sempervirens, Melatonin, Coumarinum, L-Arginine, L-Citrulline, Mercurius Corrosivus, Ubidecarenonum, Lanosterol, Mevalonolactone, Squalene, Calcarea Carbonica, Alpha-Lipoicum Acidum, Plumbum Metallicum, Pantothenic Acid, Glonoinum, Lycopodium Clavatum, Phosphorus, Berberis Vulgaris, Red Yeast Rice, Nitric Oxide, Proteus (Morgani), Rhus Tox LIQUID ORAL 20160726 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHOLESTEROL; FORMALDEHYDE; GELSEMIUM SEMPERVIRENS ROOT; MELATONIN; COUMARIN; ARGININE; CITRULLINE; MERCURIC CHLORIDE; UBIDECARENONE; LANOSTEROL; MEVALONOLACTONE; SQUALENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; THIOCTIC ACID; LEAD; PANTOTHENIC ACID; NITROGLYCERIN; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; BERBERIS VULGARIS ROOT BARK; RED YEAST; NITRIC OXIDE; PROTEUS MORGANII; TOXICODENDRON PUBESCENS LEAF 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 10; 6; 6; 6; 8; 8; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0820_778e3fa4-e47c-4ffd-a102-21d783af0dbb 43742-0820 HUMAN OTC DRUG Grain Mix System Formula Coumarinum, Quercetin, Rutin, Bamboo, Barley, Poppy Seed, Corn, Flax Seed, Cotton Seed, Millet, Milo, Oat, Rice, Rye, Safflower, Sesame, Sorghum, Soy Bean, Sugarcane, Sunflower, Wheat, Amaranth, Avena Sativa, Natrum Sulphuricum, Sarcolacticum Acidum, Triticum Repens, Adrenocorticotrophin, Sycotic Co Bacillus LIQUID ORAL 20160721 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COUMARIN; QUERCETIN; RUTIN; BAMBUSA VULGARIS LEAF; BARLEY; POPPY SEED; CORN; FLAX SEED; LEVANT COTTON SEED; MILLET; SORGHUM BICOLOR WHOLE; OAT; BROWN RICE; RYE; SAFFLOWER; SESAME SEED; SORGHUM; SOYBEAN; SUGARCANE; SUNFLOWER SEED; WHEAT; AMARANTH; AVENA SATIVA FLOWERING TOP; SODIUM SULFATE; LACTIC ACID, L-; ELYMUS REPENS ROOT; CORTICOTROPIN; ENTEROCOCCUS FAECALIS 6; 6; 6; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 6; 6; 6; 6; 6; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0821_8c1c9ace-a068-4d01-9368-da868f01814d 43742-0821 HUMAN OTC DRUG Ileocecal Valve Support Iodium, Hypophysis Suis, Thyroidinum, (Suis), Glandula Suprarenalis Suis, Fel Tauri, Taraxacum Officinale, Bryonia (Alba), Carbo Vegetabilis, Colocynthis, Indolum, Lycopodeium Clavatum, Mercurius Corrosivus, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris), LIQUID ORAL 20160803 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. IODINE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; SUS SCROFA ADRENAL GLAND; BOS TAURUS BILE; TARAXACUM OFFICINALE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CITRULLUS COLOCYNTHIS FRUIT PULP; INDOLE; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS 6; 8; 8; 10; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0822_2bbee3fb-6650-4500-93b6-4899c1ad864f 43742-0822 HUMAN OTC DRUG Brucella Homochord Brucella Melitensis LIQUID ORAL 20160726 20210803 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BRUCELLA MELITENSIS 11 [hp_C]/mL N 20181231 43742-0823_98d72f41-9ffd-4a23-934f-61a07d6b43b7 43742-0823 HUMAN OTC DRUG Lymph Drainage Citrus Limonum, Echinacea (Angustifolia), Scrophularia Nodosa, Teucrium Scorodonia, Baptisia Tinctoria, Phytolacca Decandra Pinus Sylvestris, Zincum Gluconicum, Thuja Occidentalis, Capsicum Annuum, Copper Gluconate, Manganese Gluconate, Aranea Diadema, Arsenicum Iodatum, Carpinus Betulus, Flos, Centaurium Umbellatum, Flos, Larix Decidua, Flos, Lymph Node (Suis), Spleen (Suis), Thymus (Suis), Tabacum, Lachesis Mutus LIQUID ORAL 20160816 UNAPPROVED HOMEOPATHIC Deseret Biologicals LEMON JUICE; ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; ZINC GLUCONATE; THUJA OCCIDENTALIS LEAFY TWIG; CAPSICUM; COPPER GLUCONATE; MANGANESE GLUCONATE; ARANEUS DIADEMATUS; ARSENIC TRIIODIDE; CARPINUS BETULUS FLOWER; CENTAURIUM ERYTHRAEA FLOWER; LARIX DECIDUA FLOWERING TOP; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TOBACCO LEAF; LACHESIS MUTA VENOM 1; 1; 1; 1; 1; 3; 3; 3; 4; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0824_474a1922-aeed-4a2f-b9f2-c60b160a4b27 43742-0824 HUMAN OTC DRUG Menopause Relief Sanguinaria Canadensis, Ignatia Amara, Sepia, Adenosinum Triphosphoricum Dinatrum, Bryonia (Alba), Cedron, DIM (3,3-Diindolymethane), Equol, Sulphur, Apiolum, Lachesis Mutus, Stannum Metallicum, Faecalis (Alkaligenes) LIQUID ORAL 20160726 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SANGUINARIA CANADENSIS ROOT; STRYCHNOS IGNATII SEED; SEPIA OFFICINALIS JUICE; ADENOSINE TRIPHOSPHATE DISODIUM; BRYONIA ALBA ROOT; SIMABA CEDRON SEED; 3,3'-DIINDOLYLMETHANE; EQUOL, (-)-; SULFUR; APIOLE (PARSLEY); LACHESIS MUTA VENOM; TIN; ALCALIGENES FAECALIS 3; 4; 4; 6; 6; 6; 6; 6; 6; 6; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0825_02412054-d2ba-4eae-9cd4-f2702fc143f6 43742-0825 HUMAN OTC DRUG Epstein-Barr Virus Homochord Epstein-Barr Virus Nosode LIQUID ORAL 20160804 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN HERPESVIRUS 4 15 [hp_X]/mL N 20181231 43742-0826_862609e7-a446-4665-a7c2-2cf86944b646 43742-0826 HUMAN OTC DRUG Chronagesic Dulcamara, Arnica Montana, Rhus Tox, Sanguinaria Canadensis, Cartilago Suis, Funiculus Umbilicalis Suis, Nadidum, Natrum Oxalaceticum, Pantothenic Acid, Placenta Totalis Suis, Sulphur, Chondroitin Sulphate Sodium (Bovine), Methylsulfonylmethane (MSM), Apiolum, Cinnamic Acid, Menadione, Piperine, Alpha-Lipoicum Acidum, Silicea, Symphytum Officinale, Human Growth Hormone, Gaertner Bacillus, Sycotic Co Bacillus LIQUID ORAL 20160816 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SOLANUM DULCAMARA TOP; ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SUS SCROFA CARTILAGE; SUS SCROFA UMBILICAL CORD; NADIDE; SODIUM DIETHYL OXALACETATE; PANTOTHENIC ACID; SUS SCROFA PLACENTA; SULFUR; CHONDROITIN SULFATE SODIUM (BOVINE); DIMETHYL SULFONE; APIOLE (PARSLEY); CINNAMIC ACID; MENADIONE; PIPERINE; .ALPHA.-LIPOIC ACID; SILICON DIOXIDE; COMFREY ROOT; SOMATROPIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; ENTEROCOCCUS FAECALIS 2; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0827_dc427f6b-9059-476d-81d5-3e6c88e84ac4 43742-0827 HUMAN OTC DRUG Lymphoplus Trifolium Pratense, Lymph Node (Suis), Spleen (Suis), Conium Maculatum, Echinacea (Angustifolia), Lycopodium Clavatum, Myrrha, Phytolacca Decandra, Selenium Metallicum, Silicea LIQUID ORAL 20160816 20210914 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TRIFOLIUM PRATENSE FLOWER; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHYTOLACCA AMERICANA ROOT; SELENIUM; SILICON DIOXIDE 3; 8; 8; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0828_402025cf-d5ca-4c16-8794-f40379771d71 43742-0828 HUMAN OTC DRUG Governing Vessel Conception Vessel Apis Mellifica, Arsenicum Album, Baryta Carbonica, Belladonna, Calcarea Carbonica, Cicuta Virosa, Conium Maculatum, Ferrum Metallicum, Lachesis Mutus, Lycopodium Clavatum, Mercurius Solubilis, Natrum Sulphuricum, Phosphorus, Pulsatilla (Vulgaris), Sepia, Tarentula Hispana, Thuja Occidentalis LIQUID ORAL 20160817 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CICUTA VIROSA ROOT; CONIUM MACULATUM FLOWERING TOP; IRON; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; LYCOSA TARANTULA; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0829_89298dee-9f90-4a72-a12e-6028d94d3b9e 43742-0829 HUMAN OTC DRUG Mucous Membrane Core Formula Ceanothus Americanus, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Hydrastis Canadensis, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (Vulgaris), Bile Duct (Suis), Colon (Suis), Duodenum (Suis), Esophagus (Suis), Eye (Suis), Gallbladder (Suis), Ileum (Suis), Intestine (Suis), Ipecacuanha, Jejunum (Suis), Kali Bichromicum, Lung (Suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (Suis), Pancreas Suis, Phosphorus, Rectal Mucosa (Suis), Stomach (Suis), Sulphur LIQUID ORAL 20160817 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CEANOTHUS AMERICANUS LEAF; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; MARSDENIA CONDURANGO BARK; GOLDENSEAL; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PULSATILLA VULGARIS; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; SUS SCROFA LARGE INTESTINE; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; ATROPA BELLADONNA; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0830_33ac0e48-510d-47e3-82bf-84774a364e27 43742-0830 HUMAN OTC DRUG Candida Candida Albicans LIQUID ORAL 20160817 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CANDIDA ALBICANS 1 [hp_M]/mL N 20181231 43742-0833_13d2c1fe-41f0-4c14-9bf1-73c7b6201ad5 43742-0833 HUMAN OTC DRUG Herpes Zoster Homochord Herpes Zoster Nosode LIQUID ORAL 20160818 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN HERPESVIRUS 3 15 [hp_X]/mL N 20181231 43742-0834_0cf88457-ec9c-45d0-b7f1-d70e25bd474c 43742-0834 HUMAN OTC DRUG Celeragesic Echinacea (Angustifolia), Echinacea Purpurea, Bellis Perennis, Calendula Officinalis, Hamamelis Virginiana, Aconitum Napellus, Chamomilla, Hypericum Perforatum, Belladonna, Millefolium, Bryonia (Alba), Arnica Montana, Rhus Tox, Adenosinum Triphosphoricum Dinatrum, Clematis Vitalba Flos, Helianthemum Nummularium Flos, Hepar Sulphuris Calcareum, Impatiens Glandulifera Flos, Mercurius Solubilis, Nadidum, Ornithogalum Umbellatum Flos, Prunus Cerasifera, Flos, Sarcolacticum Acidum, GEL TOPICAL 20160819 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ECHINACEA PURPUREA; BELLIS PERENNIS; ACONITUM NAPELLUS; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; ATROPA BELLADONNA; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; ADENOSINE TRIPHOSPHATE DISODIUM; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; CALCIUM SULFIDE; IMPATIENS GLANDULIFERA FLOWER; MERCURIUS SOLUBILIS; NADIDE; ORNITHOGALUM UMBELLATUM; PANTOTHENIC ACID; PRUNUS CERASIFERA FLOWER; LACTIC ACID, L-; COMFREY ROOT; UBIDECARENONE; ACTIVATED CHARCOAL; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; PROTEUS MORGANII 1; 1; 1; 2; 2; 3; 3; 3; 3; 3; 4; 4; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g N 20181231 43742-0835_add97290-7085-45ce-b6a8-3b2ee283b4ac 43742-0835 HUMAN OTC DRUG Gallic Acid Gallicum Acidum LIQUID ORAL 20160907 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GALLIC ACID 6 [hp_X]/mL N 20181231 43742-0836_4b081c96-8ace-4668-957c-40970317e766 43742-0836 HUMAN OTC DRUG Bladder Kidney Meridian Opener Apis Mellifica, Argentum Nitricum, Berberis Vulgaris, Cantharis, Equisetum Arvense, Kali Bichromicum, Lycopodium Clavatum, Mercurius Solubilis, Natrum Muriaticum, Phosphorus, Rhus Tox, Sepia, Terebinthina, Thuja Occidentalis LIQUID ORAL 20160819 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; EQUISETUM ARVENSE TOP; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; TURPENTINE OIL; THUJA OCCIDENTALIS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0837_09f83b29-24a0-43fb-a33c-4ed31439db20 43742-0837 HUMAN OTC DRUG Lyme Plus Arnica Montana, Calendula Officinalis, Echinacea (Angustifolia), Myrrha, Phytolacca Decandra, Taraxacum Officinale, Trifolium Pratense, Trigonella Foenum-Graecum, Urtica Dioica, Hydrastis Canadensis, Propolis, Adrenalinum, Gunpowder, Thymus (Suis), Thyroidinum (Suis), Arsenicum Album, Cocculus Indicus, Iridium Metallicum, Lycopodium Clavatum, Phosphorus, Rhus Tox, Babesia Microti, Borrelia Burgdorferi Nosode, Ehrlichia Nosode (Canine), Encephalitis Nosode, Ledum Palustre, Meningococcus Nosode LIQUID ORAL 20160819 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; MYRRH; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; FENUGREEK SEED; URTICA DIOICA; GOLDENSEAL; PROPOLIS WAX; EPINEPHRINE; ACTIVATED CHARCOAL; SULFUR; POTASSIUM NITRATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; ARSENIC TRIOXIDE; ANAMIRTA COCCULUS SEED; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; BABESIA MICROTI; BORRELIA BURGDORFERI; EHRLICHIA CANIS; JAPANESE ENCEPHALITIS VIRUS; LEDUM PALUSTRE TWIG; NEISSERIA MENINGITIDIS; HEPATITIS B VIRUS 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 15; 15; 15; 15; 30; 30; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0838_9e7f2b77-a24f-4d03-b8b9-fce5be8d387c 43742-0838 HUMAN OTC DRUG Salsolinol Salsolinol LIQUID ORAL 20160824 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SALSOLINOL 6 [hp_X]/mL N 20181231 43742-0839_12ac37fb-88ea-428f-8066-f43900061a80 43742-0839 HUMAN OTC DRUG Pyrrole Pyrrole LIQUID ORAL 20160907 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PYRROLE 6 [hp_X]/mL N 20181231 43742-0840_6361cb0e-6553-4bd9-8b9f-ed05f5dbb99c 43742-0840 HUMAN OTC DRUG Bartonella Homochord Bartonella Bacilliformis, Bartonella Clarridgeiae, Bartonella Elizabethae, Bartonella Henselae, Bartonella Quintana, Bartonella Vinsonii, Bartonella Washoensis LIQUID ORAL 20160907 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BARTONELLA BACILLIFORMIS; BARTONELLA CLARRIDGEIAE; BARTONELLA ELIZABETHAE; BARTONELLA HENSELAE; BARTONELLA QUINTANA; BARTONELLA VINSONII; BARTONELLA WASHOENSIS 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0841_2f42d3de-5678-4865-9267-a8ead5eb7128 43742-0841 HUMAN OTC DRUG Condylomata Homochord Human Papilloma Nosode LIQUID ORAL 20160907 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN PAPILLOMAVIRUS 15 [hp_X]/mL N 20181231 43742-0842_9f524ebd-bb23-43b8-ab5b-e4164e2b450d 43742-0842 HUMAN OTC DRUG Coxsackie Homochord Coxsackie Nosode A2, Coxsackie Nosode A7, Coxsackie Nosode B1, Coxsackie Nosode B3, Coxsackie Nosode B4 LIQUID ORAL 20160907 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B3; HUMAN COXSACKIEVIRUS B4 7; 7; 7; 7; 7 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0843_3c214603-a58b-4c83-9eb2-5f2701f487b4 43742-0843 HUMAN OTC DRUG Mycoplasma Homochord Mycoplasma Pneumoniae LIQUID ORAL 20160908 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MYCOPLASMA PNEUMONIAE 15 [hp_X]/mL N 20181231 43742-0844_87139b95-22e7-481c-8d91-2900df161e12 43742-0844 HUMAN OTC DRUG Bio Lymph Phase Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla (Smilax Regelii), Ascorbic Acid, Quercetin, Calcarea Phosphorica, Ferrum Iodatum, Thyroidinum (Suis), Gaertner Bacillus LIQUID ORAL 20160908 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; ARANEUS DIADEMATUS; SMILAX REGELII ROOT; ASCORBIC ACID; QUERCETIN; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA THYROID; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 5; 5; 5; 6; 6; 6; 6; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0845_23944e82-a149-43ea-a470-e3a4a9b6738c 43742-0845 HUMAN OTC DRUG Bio Mood Phase Cortisone Aceticum, Adrenalinum, Chininum Arsenicosum, Helonias Dioica, Hypericum Perforatum, Kali Phosphoricum, Nux Vomica, Selenium Metallicum, Aurum Metallicum, Bacillus 7 (Enterobacter Cloacae) LIQUID ORAL 20160908 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CORTISONE ACETATE; EPINEPHRINE; QUININE ARSENATE; CHAMAELIRIUM LUTEUM ROOT; HYPERICUM PERFORATUM; DIBASIC POTASSIUM PHOSPHATE; STRYCHNOS NUX-VOMICA SEED; SELENIUM; GOLD; ENTEROBACTER CLOACAE 6; 6; 10; 10; 10; 10; 10; 10; 10; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0846_357b06b9-45e1-4319-b0c3-6f875528cbe1 43742-0846 HUMAN OTC DRUG Heart/Fatigue Spigelia Anthelmia, Kali Carbonicum, Arnica Montana, Cactus Grandiflorus, Gelsemium Sempervirens, Castoreum, Glonoinum, Ranunculus Bulbosus, Heart (Suis), Abrotanum, Sulphur LIQUID ORAL 20160912 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SPIGELIA ANTHELMIA; POTASSIUM CARBONATE; ARNICA MONTANA; SELENICEREUS GRANDIFLORUS STEM; GELSEMIUM SEMPERVIRENS ROOT; CASTOR CANADENSIS SCENT GLAND SECRETION; NITROGLYCERIN; RANUNCULUS BULBOSUS; PORK HEART; ARTEMISIA ABROTANUM FLOWERING TOP; SULFUR 2; 3; 4; 4; 4; 6; 6; 6; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0847_202718ca-9caf-40cd-8086-eae481135d56 43742-0847 HUMAN OTC DRUG Celeragesic Echinacea (Angustifolia), Calendula Officinalis, Hamamelis Virginiana, Echinacea Purpurea, Bellis Perennis, Aconitum Napellus, Chamomilla, Hypericum Perforatum, Belladonna, Millefolium, Bryonia (Alba), Arnica Montana, Rhus Tox, Adenosinum Triphosphoricum Dinatrum, Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Hepar Sulphuris Calcareum, Impatiens Glandulifera, Flos, Mercurius Solubilis, Nadidum, Ornithogalum Umbellatum, Flos, Pantothenic Acid, Prunus Cerasifera, Flos, Sarcolacticum Acidum LIQUID ORAL 20160915 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ECHINACEA PURPUREA; BELLIS PERENNIS; ACONITUM NAPELLUS; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; ATROPA BELLADONNA; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; ADENOSINE TRIPHOSPHATE DISODIUM; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; CALCIUM SULFIDE; IMPATIENS GLANDULIFERA FLOWER; MERCURIUS SOLUBILIS; NADIDE; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PANTOTHENIC ACID; PRUNUS CERASIFERA FLOWER; LACTIC ACID, L-; COMFREY ROOT; UBIDECARENONE; ACTIVATED CHARCOAL; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; PROTEUS MORGANII 1; 1; 1; 2; 2; 3; 3; 3; 3; 3; 4; 4; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0848_762cd4cd-e636-4806-9db1-1a2bd8ac354f 43742-0848 HUMAN OTC DRUG Trauma Remedy Chamomilla, Echinacea (Angustifolia), Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Bryonia (Alba), Calendula Officinalis, Arnica Montana, Belladonna, Bellis Perennis, Rhus Tox, Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Hepar Sulphuris Calcareum, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos, Carbo Vegetabilis LIQUID ORAL 20160915 20220504 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; TOXICODENDRON PUBESCENS LEAF; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; CALCIUM SULFIDE; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; ACTIVATED CHARCOAL 3; 3; 3; 3; 3; 4; 4; 4; 6; 6; 6; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0849_506d1b99-d904-4760-8a3c-74fb915df067 43742-0849 HUMAN OTC DRUG Inflammation II Asafoetida, Kalmia Latifolia, Causticum, Colchicum Autumnale, Ferrum Metallicum, Gnaphalium Polycephalum, Lithium Benzoicum, Mercurius Praecipitatus Ruber, Rhus Tox, Spiraea Ulmaria LIQUID ORAL 20160915 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. FERULA ASSA-FOETIDA RESIN; KALMIA LATIFOLIA LEAF; CAUSTICUM; COLCHICUM AUTUMNALE BULB; IRON; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LITHIUM BENZOATE; MERCURIC OXIDE; TOXICODENDRON PUBESCENS LEAF; FILIPENDULA ULMARIA ROOT 8; 8; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 43742-0850_a1deda09-3823-4eb8-814b-f16dd71f65cf 43742-0850 HUMAN OTC DRUG Gallbladder Liver Meridian Opener Arsenicum Album, Berberis Vulgaris, Bryonia (Alba), Calcarea Carbonica, Carduus Marianus, Cinchona Officinalis, Kali Carbonicum, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus LIQUID ORAL 20160915 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MILK THISTLE; CINCHONA OFFICINALIS BARK; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0851_9cd59bf8-d133-4cec-a7ed-d8a4e0e5786f 43742-0851 HUMAN OTC DRUG Progesterone Progesterone LIQUID ORAL 20160919 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PROGESTERONE 6 [hp_X]/mL N 20181231 43742-0852_3dd91554-869e-4dac-a38c-fab5dcd4b776 43742-0852 HUMAN OTC DRUG Spine and Nerve Balance Core Formula Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Cuprum Aceticum, Nadidum, Natrum Oxalaceticum, Nicotinamidum, Picricum Acidum, Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, alpha-Lipoicum Acidum, Ammonium Muriaticum, Cartilago Suis, Discus Intervertebralis (Suis), Silicea, Argentum Metallicum, Calcarea Phosphorica, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis LIQUID ORAL 20160919 UNAPPROVED HOMEOPATHIC Deseret Biologicals Inc. BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; CUPRIC ACETATE; NADIDE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PICRIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; .ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SUS SCROFA BONE MARROW; MERCURIC OXIDE; PANTOTHENIC ACID; SULFUR; ENTEROBACTER CLOACAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII; PROTEUS VULGARIS 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 28; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0853_c275d3d8-90aa-4ac5-8afc-5f0ccfbae63d 43742-0853 HUMAN OTC DRUG Toxoplasma Homochord Toxoplasma Gondii LIQUID ORAL 20160919 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TOXOPLASMA GONDII 15 [hp_X]/mL N 20181231 43742-0854_f8165fff-2c81-44cd-bbeb-12b12a259c16 43742-0854 HUMAN OTC DRUG Borrelia-Babesia Homochord Babesia Microti, Borrelia Burgdorferi Nosode LIQUID ORAL 20160919 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BABESIA MICROTI; BORRELIA BURGDORFERI 15; 15 [hp_X]/mL; [hp_X]/mL N 20181231 43742-0855_bf0eb1f4-7342-45e0-a826-a6ad3065161e 43742-0855 HUMAN OTC DRUG Bio Placenta Phase Aesculus Hippocastanum, Sarcolacticum Acidum, Secale Cornutum, Cuprum Sulphuricum, Melilotus Officinalis, Placenta Totalis Suis, Solanum Nigrum, Strophanthus Hispidus, Dhea (Dehydroepiandrosterone), Quercetin, Rutin, Natrum Pyruvicum, Vein (Suis), Arteria (Suis), Funiculus Umbilicalis Suis, Tabacum, Vipera Berus, Baryta Carbonica, Plumbum Iodatum, Astragalus Exscapus, Proteus (Vulgaris) LIQUID ORAL 20160919 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HORSE CHESTNUT; LACTIC ACID, L-; CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC SULFATE; MELILOTUS OFFICINALIS TOP; SUS SCROFA PLACENTA; SOLANUM NIGRUM WHOLE; STROPHANTHUS HISPIDUS SEED; PRASTERONE; QUERCETIN; RUTIN; SODIUM PYRUVATE; SUS SCROFA VEIN; SUS SCROFA ARTERY; SUS SCROFA UMBILICAL CORD; TOBACCO LEAF; VIPERA BERUS VENOM; BARIUM CARBONATE; LEAD IODIDE; ASTRAGALUS EXSCAPUS WHOLE FLOWERING/FRUITING; PROTEUS VULGARIS 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 10; 10; 10; 10; 13; 18; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0856_b2cf6953-d7c5-4969-af13-9a0ac9ddf0bc 43742-0856 HUMAN OTC DRUG Acetaldehyde Acetaldehyde LIQUID ORAL 20160906 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACETALDEHYDE 6 [hp_X]/mL N 20181231 43742-0857_ec6d087f-c399-44bb-8a61-b1cac2e85411 43742-0857 HUMAN OTC DRUG Osteoreg Asafoetida, Kali Iodatum, Natrum Sulphuricum, Stillingia Sylvatica, Aranea Diadema, Vitamin D3, Hydrocortisone (Cortisol), Mercurius Praecipitatus Ruber, Calcarea Phosphorica, Hekla Lava, Parathyroid Gland (Bovine), Aurum Metallicum, Lycopodium Clavatum, Gaertner Bacillus (Bach) LIQUID ORAL 20160921 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ASAFETIDA; POTASSIUM IODIDE; SODIUM SULFATE; STILLINGIA SYLVATICA ROOT; ARANEUS DIADEMATUS; CHOLECALCIFEROL; HYDROCORTISONE; MERCURIC OXIDE; TRIBASIC CALCIUM PHOSPHATE; HEKLA LAVA; BOS TAURUS PARATHYROID GLAND; GOLD; LYCOPODIUM CLAVATUM SPORE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 4; 4; 4; 6; 6; 6; 8; 8; 8; 8; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0858_d9fe3033-71ec-418c-8d73-4ed7b7e2c7a2 43742-0858 HUMAN OTC DRUG Kidney Drainage Solidago Virgaurea, Asparagus Officinalis, Juniperus Communis, Sabal Serrulata, Uva Ursi, Berberis Vulgaris, Equisetum Arvense, Rhus Aromatica, Urtica Dioica, Cantharis, Rubia Tinctorum, Staphysagria, Cobaltum Metallicum, Fagus Sylvatica Flos, Glandula Suprarenalis Suis, Hepar Sulphuris Calcareum, Kidney (Suis), Larix Decidua Flos, Manganum Metallicum, Mimulus Guttatus Flos, Nitricum Acidum, Silicea, Ulex Europaeus Flos, Benzoicum Acidum LIQUID ORAL 20161003 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SOLIDAGO VIRGAUREA FLOWERING TOP; ASPARAGUS; JUNIPERUS COMMUNIS WHOLE; SAW PALMETTO; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; EQUISETUM ARVENSE TOP; RHUS AROMATICA ROOT BARK; URTICA DIOICA; LYTTA VESICATORIA; RUBIA TINCTORUM ROOT; DELPHINIUM STAPHISAGRIA SEED; COBALT; FAGUS SYLVATICA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; CALCIUM SULFIDE; PORK KIDNEY; LARIX DECIDUA FLOWERING TOP; MANGANESE; MIMULUS GUTTATUS FLOWERING TOP; NITRIC ACID; SILICON DIOXIDE; ULEX EUROPAEUS FLOWER; BENZOIC ACID 1; 2; 2; 2; 2; 3; 3; 3; 3; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0859_5eee025d-c969-4477-a1c2-b678a6b6d7f7 43742-0859 HUMAN OTC DRUG EBV/CFS Plus Baptisia Tinctoria, Condurango, Echinacea (Angustifolia), Ligusticum Porteri, Nasturtium Aquaticum, Phytolacca Decandra, Tabebuia Impetiginosa, Astragalus Menziesii, Hydrastis Canadensis, Propolis, Glandula Suprarenalis Suis, Thymus (Suis), Aranea Diadema, Gelsemium Sempervirens, Ipecacuanha, Lycopodium Clavatum, Mercurius Solubilis, Muriaticum Acidum, Nitricum Acidum, Rhus Tox, Selenium Metallicum, Silicea, Epstein-Barr Virus Nosode LIQUID ORAL 20161003 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BAPTISIA TINCTORIA ROOT; MARSDENIA CONDURANGO BARK; ECHINACEA ANGUSTIFOLIA; LIGUSTICUM PORTERI ROOT; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; TABEBUIA IMPETIGINOSA BARK; ASTRAGALUS NUTTALLII LEAF; GOLDENSEAL; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; ARANEUS DIADEMATUS; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; HYDROCHLORIC ACID; NITRIC ACID; TOXICODENDRON PUBESCENS LEAF; SELENIUM; SILICON DIOXIDE; HUMAN HERPESVIRUS 4 3; 3; 3; 3; 3; 3; 3; 6; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0860_b4833671-420c-4961-b2d5-9bcc9d6bca74 43742-0860 HUMAN OTC DRUG Gum Therapy Calendula Officinalis, Eugenia Caryophyllata, Plantago Major, Phytolacca Decandra, Arnica Montana, Phosphorus, Peptostreptococcus, Carbo Vegetabilis, Hepar Sulphuris Calcareum, Lachesis Mutus, Mercurius Solubilis LIQUID ORAL 20161003 UNAPPROVED HOMEOPATHIC Deseret Biologicals CALENDULA OFFICINALIS FLOWERING TOP; CLOVE; PLANTAGO MAJOR; PHYTOLACCA AMERICANA ROOT; ARNICA MONTANA; PHOSPHORUS; PEPTOSTREPTOCOCCUS ANAEROBIUS; ACTIVATED CHARCOAL; CALCIUM SULFIDE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS 1; 1; 1; 2; 3; 12; 15; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0861_6c1be7ae-4043-418e-aa14-7ce7b677de19 43742-0861 HUMAN OTC DRUG FNG Berberis Vulgaris, Cochlearia Armoracia, Echinacea (Angustifolia), Lomatium Dissectum, Myrrha, Tabebuia Impetiginosa, Hydrastis Canadensis, Propolis, Formalinum, Glandula Suprarenalis Suis, Thymus (Suis), Ferrum Metallicum, Iridium Metallicum, Lycopodium Clavatum, Phosphoricum Acidum, Pulsatilla (Vulgaris), Selenium Metallicum, Zincum Metallicum, Adenosinum Triphosphoricum Dinatrum, Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Pullularia Pullulans LIQUID ORAL 20161004 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; MYRRH; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; PROPOLIS WAX; FORMALDEHYDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; IRON; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PULSATILLA VULGARIS; SELENIUM; ZINC; ADENOSINE TRIPHOSPHATE DISODIUM; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; METHYLCOBALAMIN; LACTIC ACID, L-; STACHYBOTRYS CHARTARUM; ESCHERICHIA COLI; BRUGIA MALAYI 3; 3; 3; 3; 3; 6; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0862_6cad3d4c-a2b0-451a-89f9-9629f873ba71 43742-0862 HUMAN OTC DRUG Bladder Kidney Meridian Formula Cinnamic Acid, Phloridzinum, Alpha-Ketoglutaricum Acidum, Ascorbic Acid, Kidney (Suis), Malicum Acidum, Nicotinamidum, Urinary Bladder (Suis), Adrenocorticotrophin, Apis Mellifica, Argentum Nitricum, Berberis Vulgaris, Cantharis, Equisetum Arvense, Kali Bichromicum, Lycopodium Clavatum, Mercurius Solubilis, Natrum Muriaticum, Phosphorus, Rhus Tox, Sepia, Terebinthina, Thuja Occidentalis, Dysentery Bacillus, Faecalis (Alkaligenes), Proteus (Vulgaris) LIQUID ORAL 20161004 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CINNAMIC ACID; PHLORIZIN; OXOGLURIC ACID; ASCORBIC ACID; PORK KIDNEY; MALIC ACID; NIACINAMIDE; SUS SCROFA URINARY BLADDER; CORTICOTROPIN; APIS MELLIFERA; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; EQUISETUM ARVENSE TOP; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; TURPENTINE OIL; THUJA OCCIDENTALIS LEAFY TWIG; SHIGELLA DYSENTERIAE; ALCALIGENES FAECALIS; PROTEUS VULGARIS 6; 6; 6; 6; 6; 6; 6; 6; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0863_06a44c64-4b8c-4e3b-98fa-40044f33c5d1 43742-0863 HUMAN OTC DRUG Candida Albicans Homochord Candida Albicans LIQUID ORAL 20161005 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CANDIDA ALBICANS 15 [hp_X]/mL N 20181231 43742-0864_82659cf2-4bc4-455b-87ce-9daf26939a50 43742-0864 HUMAN OTC DRUG Candida Plus Echinacea (Angustifolia), Phytolacca Decandra, Hydrastis Canadensis, Acetaldehyde, Caffeic Acid, Gallicum Acidum, Indolum, Mannan, Lycopodium Clavatum, Mercurius Solubilis, Pulsatilla Vulgaris, Sepia, Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Pullularia Pullulans, Rhizopus Nigricans, Torula Cerevisiae, Candida Albicans, Brugia Malayi LIQUID ORAL 20161005 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; ACETALDEHYDE; CAFFEIC ACID; GALLIC ACID; INDOLE; YEAST MANNAN; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE; CANDIDA ALBICANS; BRUGIA MALAYI 3; 3; 6; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 60; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0866_5875f79a-0962-4620-ab0a-5f45c8120339 43742-0866 HUMAN OTC DRUG Cytomegalovirus Homochord Cytomegalovirus Nosode LIQUID ORAL 20161005 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc HUMAN HERPESVIRUS 5 18 [hp_X]/mL N 20181231 43742-0867_4dda71fb-1f16-4f9b-8e9a-2e823434f4b5 43742-0867 HUMAN OTC DRUG Mannan Mannan LIQUID ORAL 20161005 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. YEAST MANNAN 6 [hp_X]/mL N 20181231 43742-0868_7dda1253-1296-42e6-9f13-61304cd30f26 43742-0868 HUMAN OTC DRUG Systemic Detox Beta Vulgaris, Boldo, Chelidonium Majus, Sarsaparilla (Smilax Regelii), Gelsemium Sempervirens, Veratrum Album, Ferrum Metallicum, Iodium, Lycopodium Clavatum, Nux Vomica, Pulsatilla (Vulgaris), Selenium Metallicum, Thuja Occidentalis, Zincum Metallicum LIQUID ORAL 20161006 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; SARSAPARILLA; GELSEMIUM SEMPERVIRENS ROOT; VERATRUM ALBUM ROOT; IRON; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SELENIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 3; 3; 3; 6; 7; 7; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0869_cb418c23-1fd1-454c-a515-353e31c0ea06 43742-0869 HUMAN OTC DRUG Detox III Conium Maculatum, Dulcamara, Echinacea (Angustifolia), Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid, Coccus Cacti, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Pulsatilla (Vulgaris), Sarcolacticum Acidum, Lymph Node (Suis), Sulphur, Glandula Suprarenalis Suis, L-Phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (Suis), Spleen (Suis), Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Glyphosate, Funiculus Umbilicalis Suis LIQUID ORAL 20161006 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA ANGUSTIFOLIA; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; PULSATILLA VULGARIS; LACTIC ACID, L-; SUS SCROFA LYMPH; SULFUR; SUS SCROFA ADRENAL GLAND; PHENYLALANINE; TRIBASIC CALCIUM PHOSPHATE; FERRUM PHOSPHORICUM; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA SPLEEN; CORTISONE ACETATE; MERCURIUS SOLUBILIS; BARIUM CARBONATE; GLYPHOSATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA TONSIL; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; LIOTHYRONINE; SUS SCROFA BONE MARROW; BISPHENOL A; BROMINE; CHLORINE; HYDROFLUORIC ACID; IODINE; ESCHERICHIA COLI 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 10; 10; 10; 10; 10; 13; 13; 28; 1000; 6; 6; 9; 10; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0870_49374ee8-57a8-4e94-8a34-4a48c7536bb2 43742-0870 HUMAN OTC DRUG Ver Filix Mas, Artemisia Vulgaris, Cina, Melilotus Officinalis, Quassia (Amara), Spigelia Anthelmia, Teucrium Marum, Thymus Serpyllum, Silicea, Calcarea Carbonica, Graphites, Iodium, Mercurius Corrosivus, Sabadilla, Ascaris Lumbricoides, Trichinella Spiralis, Enterobius Vermicularis, Taenia Solium, Trichomonas Vaginalis, Giardia Lamblia, Cryptosporidium Parvum, Taenia Saginata, Brugia Malayi LIQUID ORAL 20161006 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DRYOPTERIS FILIX-MAS ROOT; ARTEMISIA VULGARIS ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; MELILOTUS OFFICINALIS TOP; QUASSIA AMARA WOOD; SPIGELIA ANTHELMIA; TEUCRIUM MARUM; THYMUS SERPYLLUM; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; IODINE; MERCURIC CHLORIDE; SCHOENOCAULON OFFICINALE SEED; ASCARIS LUMBRICOIDES; TRICHINELLA SPIRALIS; ENTEROBIUS VERMICULARIS; TAENIA SOLIUM; TRICHOMONAS VAGINALIS; GIARDIA LAMBLIA; CRYPTOSPORIDIUM PARVUM; TAENIA SAGINATA; BRUGIA MALAYI 1; 2; 3; 3; 3; 3; 3; 3; 8; 12; 12; 12; 12; 12; 15; 15; 33; 12; 13; 18; 20; 20; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0871_7ab5c411-8b73-4bf8-9c8a-b0e43999ec71 43742-0871 HUMAN OTC DRUG Free Radical Alfalfa, Ascorbyl Palmitate, Cysteinum, Hordeum Vulgare, Laminaria Digitata, Manganese Gluconate, L-Methionine, Nasturtium Aquaticum, Dimethyl Glycine, Quercetin, Raphanus Sativus, Sodium Selenite, Triticum Aestivum, Ubidecarenonum, alpha-Lipoicum Acidum, Oryza Sativa, Tocopherol, Zinc Picolinate, Cobaltum Metallicum, Ferrum Metallicum, Glutathione, Magnesium Fluoratum, Selenium Metallicum, Zincum Metallicum, alpha-Ketoglutaricum Acidum, Glyoxal Trimer Dihydrate LIQUID ORAL 20161012 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALFALFA; ASCORBYL PALMITATE; CYSTEINE; BARLEY; LAMINARIA DIGITATA; MANGANESE GLUCONATE; METHIONINE; NASTURTIUM OFFICINALE; N,N-DIMETHYLGLYCINE; QUERCETIN; RAPHANUS SATIVUS; SODIUM SELENITE; WHEAT; UBIDECARENONE; .ALPHA.-LIPOIC ACID; ORYZA SATIVA WHOLE; .ALPHA.-TOCOPHEROL; ZINC PICOLINATE; COBALT; IRON; GLUTATHIONE; MAGNESIUM FLUORIDE; SELENIUM; ZINC; .ALPHA.-KETOGLUTARIC ACID; GLYOXAL TRIMER DIHYDRATE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0872_4d6cc505-3b95-4a54-a8aa-2e6247bb440a 43742-0872 HUMAN OTC DRUG Epstein-Barr Virus Kit Epstein-Barr Virus Nosode KIT 20160527 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. N 20181231 43742-0883_7ecdc284-4b6b-40af-98a2-6e57dd2a59dc 43742-0883 HUMAN OTC DRUG Borrelia Babesia Kit Babesia Microti, Borrelia Burgdorferi Nosode KIT 20161027 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. N 20181231 43742-0894_28965c90-e51f-4cce-b188-8891fcfef8a3 43742-0894 HUMAN OTC DRUG Brucella Homochord Brucella Melitensis LIQUID ORAL 20161028 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BRUCELLA MELITENSIS 11 [hp_C]/mL N 20181231 43742-0895_92421b68-982c-4e0f-979f-1f76e32c095c 43742-0895 HUMAN OTC DRUG Bio Cytotox Phase Colchicum Autumnale, Conium Maculatum, Vaccinium Myrtillus, Podophyllum Peltatum, Ascorbicum Acidum, Galium Aparine, Hydrastis Canadensis, Nicotinamidum, Pyridoxinum Hydrochloricum, Riboflavinum, Sarcolacticum Acidum, Thiaminum Hydrochloricum, Norepinephrine, alpha-Lipoicum Acidum, Natrum Oxalaceticum, Sulphur, Acetylsalicylicum Acidum, Adenosinum Triphosphoricum Dinatrum, Anthrachinonum, Histaminum Hydrochloricum, Magnesium Gluconicum Dihydricum, Nadidum, Naphthochinonum, Pantothenic Acid, Ubidecarenonum, LIQUID ORAL 20161020 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; BILBERRY; PODOPHYLLUM; ASCORBIC ACID; GALIUM APARINE; GOLDENSEAL; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; LACTIC ACID, L-; THIAMINE HYDROCHLORIDE; NOREPINEPHRINE; THIOCTIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; ASPIRIN; ADENOSINE TRIPHOSPHATE DISODIUM; ANTHRAQUINONE; HISTAMINE DIHYDROCHLORIDE; MAGNESIUM GLUCONATE; NADIDE; NAPHTHOQUINE; UBIDECARENONE; PANTOTHENIC ACID; MANGANESE PHOSPHATE, DIBASIC; HYDROQUINONE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 4; 4; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0896_3075cdf4-d3d6-450d-b384-cdc8ceb18617 43742-0896 HUMAN OTC DRUG Bio Co-Enzyme Phase Beta Vulgaris, Ascorbic Acid, Cysteinum, Natrum Oxalaceticum, Nicotinamidum, Pulsatilla (Vulgaris), Pyridoxinum, Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Adrenalinum, Aconiticum Acidum, Cis, Alpha-Ketoglutaricum Acidum, Alpha-Lipoicum Acidum, Cerium Oxalicum, Citricum Acidum, Fumaricum Acidum, Magnesium Oroticum Dihydricum, Malicum Acidum, Nadidum, Natrum Pyruvicum, Pantothenic Acid, Succinicum Acidum, Adenosinum Triphosphoricum Dinatrum, Hepar Sulphuris Calcareum, Sulphur LIQUID ORAL 20170222 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; ASCORBIC ACID; CYSTEINE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; EPINEPHRINE; ACONITIC ACID, (Z)-; OXOGLURIC ACID; THIOCTIC ACID; CEROUS OXALATE NONAHYDRATE; ANHYDROUS CITRIC ACID; FUMARIC ACID; MAGNESIUM OROTATE DIHYDRATE; MALIC ACID; NADIDE; SODIUM PYRUVATE; PANTOTHENIC ACID; SUCCINIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; CALCIUM SULFIDE; SULFUR; MANGANESE PHOSPHATE, DIBASIC; BARIUM OXALOSUCCINATE; PROTEUS MORGANII 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 16; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0897_fc689af0-b060-4fc8-a7ee-4d9b9c2fe036 43742-0897 HUMAN OTC DRUG Phenylalanine Phenylalanine LIQUID ORAL 20161031 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHENYLALANINE 6 [hp_X]/mL N 20181231 43742-0898_95b0a10c-203f-4af0-bfdc-19ba6f61acad 43742-0898 HUMAN OTC DRUG Herpes Simplex Homochord Herpes Simplex I, Herpes Simplex II LIQUID ORAL 20161117 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2 15; 15 [hp_X]/mL; [hp_X]/mL N 20181231 43742-0899_a8b0e8c8-9bc4-446c-ac5c-1f90ba331c50 43742-0899 HUMAN OTC DRUG Amoeba Baptisia Tinctoria, Cajuputum, Capsicum Annuum, Fragaria Vesca, Frasera Caroliniensis, Hamamelis Virginiana, Quassia (Amara), Senna (Cassia Angustifolia), Hydrastis Canadensis, Ipecacuanha, Hepar Suis, Pancreas Suis, Spleen (Suis), Belladonna, Cinchona Officinalis, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Selenium Metallicum, Blastocystis Hominis, Cryptosporidium Parvum, Entamoeba Histolytica, Giardia Lamblia, Brugia Malayi LIQUID ORAL 20161108 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BAPTISIA TINCTORIA ROOT; CAJUPUT OIL; CAPSICUM; ALPINE STRAWBERRY; FRASERA CAROLINIENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; QUASSIA AMARA WOOD; SENNA LEAF; GOLDENSEAL; IPECAC; PORK LIVER; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; SELENIUM; BLASTOCYSTIS HOMINIS; CRYPTOSPORIDIUM PARVUM; ENTAMOEBA HISTOLYTICA; GIARDIA LAMBLIA; BRUGIA MALAYI 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0900_cd4c0ce3-bcb7-41a2-8bf8-60e6cbc69d09 43742-0900 HUMAN OTC DRUG Peptostrep Homochord Peptostreptococcus Anaerobius LIQUID ORAL 20161117 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PEPTOSTREPTOCOCCUS ANAEROBIUS 19 [hp_X]/mL N 20181231 43742-0901_d60e6398-44b8-46fe-8eee-ca43225cee09 43742-0901 HUMAN OTC DRUG H. Pylori Homochord Helicobacter Pylori LIQUID ORAL 20161110 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HELICOBACTER PYLORI 15 [hp_X]/mL N 20181231 43742-0904_8d9e392a-dc66-4db4-a21e-7f05c7c2d750 43742-0904 HUMAN OTC DRUG Bartonella Kit Bartonella Bacilliformis, Bartonella Clarridgeiae, Bartonella Elizabethae, Bartonella Henselae, Bartonella Quintana, Bartonella Vinsonii, Bartonella Washoensis KIT 20161128 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. N 20181231 43742-0915_7a7ca128-d605-4ae7-888a-2b397b937dff 43742-0915 HUMAN OTC DRUG Petrochemical Detox Chelidonium Majus, Symphytum Officinale, Taraxacum Officinale, Trifolium Pratense, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Arsenicum Album, Cadmium Sulphuratum, Gelsemium Sempervirens, Iridium Metallicum, Lycopodium Clavatum, Mercurius Solubilis, Nitricum Acidum, Nitricum Acidum, Nux Vomica, Petroleum, Phosphoricum Acidum, Platinum Metallicum, Latrodectus Mactans LIQUID ORAL 20161128 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHELIDONIUM MAJUS; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; COMFREY ROOT; ACETONE; AMMONIUM CHLORIDE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; TURPENTINE OIL; ARSENIC TRIOXIDE; CADMIUM SULFIDE; GELSEMIUM SEMPERVIRENS ROOT; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORIC ACID; PLATINUM; LATRODECTUS MACTANS 3; 3; 6; 6; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0916_0c0ca39f-1970-4e0e-99d2-9b845b51a9f1 43742-0916 HUMAN OTC DRUG Pertussis Aconitum Napellus, Belladonna, Bryonia (Alba), Hyoscyamus Niger, Ipecacuanha, Sticta Pulmonaria, Tabacum, Phosphorus, Antimonium Tartaricum, Kreosotum, Silicea, Pertussinum, Tetanus Toxin LIQUID ORAL 20161128 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; HYOSCYAMUS NIGER; IPECAC; LOBARIA PULMONARIA; TOBACCO LEAF; PHOSPHORUS; ANTIMONY POTASSIUM TARTRATE; WOOD CREOSOTE; SILICON DIOXIDE; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; CLOSTRIDIUM TETANI 4; 4; 4; 4; 4; 4; 4; 5; 6; 6; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0917_4b8f6119-bcf8-4135-88b9-6544a1c9250e 43742-0917 HUMAN OTC DRUG Candida Albicans Kit Candida Albicans KIT 20161129 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. N 20181231 43742-0928_d0be1a54-11e0-48ee-85eb-a785a062e051 43742-0928 HUMAN OTC DRUG H. Pylori Kit Helicobacter Pylori KIT 20161128 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. N 20181231 43742-0939_8c4572c0-afa3-44eb-8df9-85004f9d0f4e 43742-0939 HUMAN OTC DRUG Elevate Lycopodium Clavatum, Natrum Muriaticum, Sepia, Belladonna, Causticum, Phosphorus, Sulphur, 5-Hydroxytryptophan, Alumina, Silicea, Acetylcholine Chloride, Dopamine Hydrochloride, Norepinephrine, Phenylethylamine (Hydrochloride), Serotonin (Hydrochloride), Adenosinum Cyclophosphoricum, Cerebrum (Suis), Diencephalon (Suis), Funiculus Umbilicalis Suis, Pantothenic Acid, Pineal Gland (Suis), Sarcolacticum Acidum, Faecalis (Alkaligenes), Gaertner Bacillus (Bach), Proteus (Vulgaris) LIQUID ORAL 20161129 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SEPIA OFFICINALIS JUICE; ATROPA BELLADONNA; CAUSTICUM; PHOSPHORUS; SULFUR; OXITRIPTAN; ALUMINUM OXIDE; SILICON DIOXIDE; ACETYLCHOLINE CHLORIDE; DOPAMINE HYDROCHLORIDE; NOREPINEPHRINE; PHENETHYLAMINE HYDROCHLORIDE; SEROTONIN HYDROCHLORIDE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA UMBILICAL CORD; PANTOTHENIC ACID; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; ALCALIGENES FAECALIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS VULGARIS 3; 3; 3; 4; 4; 4; 4; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0940_2abc426e-cf89-4684-b2f4-e495e20a2bf6 43742-0940 HUMAN OTC DRUG Sinusitis Pulsatilla (Vulgaris), Plantago Major, Euphorbium Officinarum, Luffa Operculata, Mercurius Iodatus Ruber, Mucosa Nasalis Suis, Argentum Nitricum, Hepar Sulphuris Calcareum, Calcarea Carbonica, Natrum Muriaticum, Sinusitisinum LIQUID ORAL 20161207 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PULSATILLA VULGARIS; PLANTAGO MAJOR; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SUS SCROFA NASAL MUCOSA; SILVER NITRATE; CALCIUM SULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; SINUSITISINUM 1; 3; 4; 6; 8; 8; 10; 10; 12; 12; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0941_11af4332-e4d5-49ac-a364-f9eaff054f83 43742-0941 HUMAN OTC DRUG Aspartame/MSG Detox Chelidonium Majus, Phytolacca Decandra, Arnica Montana, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum, Bisphenol A (BPA), Dextrose, Maltodextrin, Sucralose, Aspartic Acid, Diketopiperazine, Dopamine Hydrochloride, Formalinum, Formicum Acidum, L-Phenylalanine, Methyl Alcohol, Monosodium Glutamate LIQUID ORAL 20161227 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHELIDONIUM MAJUS; PHYTOLACCA AMERICANA ROOT; ARNICA MONTANA; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; BISPHENOL A; DEXTROSE MONOHYDRATE; MALTODEXTRIN; SUCRALOSE; ASPARTIC ACID; 2,5-PIPERAZINEDIONE; DOPAMINE HYDROCHLORIDE; FORMALDEHYDE; FORMIC ACID; METHYL ALCOHOL; MONOSODIUM GLUTAMATE; PHENYLALANINE 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0943_4bdcb1e4-6750-42ab-8d64-f74e81c2851b 43742-0943 HUMAN OTC DRUG Nerve Z Condurango, Echinacea (Angustifolia), Ginkgo Biloba, Ligusticum Porteri, Myrrha, Phytolacca Decandra, Tabebuia Impetiginosa, Hydrastis Canadensis, Propolis, Glandula Suprarenalis Suis, Spleen (Suis), Thymus (Suis), Thyroidinum (Suis), Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Selenium Metallicum, Pyrogenium LIQUID ORAL 20161227 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MARSDENIA CONDURANGO BARK; ECHINACEA ANGUSTIFOLIA; GINKGO; LIGUSTICUM PORTERI ROOT; MYRRH; PHYTOLACCA AMERICANA ROOT; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SUS SCROFA THYROID; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SELENIUM; RANCID BEEF 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0944_ee80f645-8cb9-4965-b302-f33eae369803 43742-0944 HUMAN OTC DRUG Oratox Fucus Vesiculosus, Lymph Node (Suis), Medulla Ossis Suis, Thymus (Suis), Thyroidinum (Suis), Calcarea Muriatica, Iodium, Natrum Fluoratum, Natrum Muriaticum, Selenium Metallicum, Vanadium Metallicum, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Eugenol, Formalinum, Lidocaine, Mercurius Solubilis, Molybdenum Metallicum, Niccolum Metallicum, Palladium Metallicum, Stannum Metallicum, Titanium Metallicum, Zincum Metallicum LIQUID ORAL 20161227 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. FUCUS VESICULOSUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA THYMUS; SUS SCROFA THYROID; CALCIUM CHLORIDE; IODINE; SODIUM FLUORIDE; SODIUM CHLORIDE; SELENIUM; VANADIUM; SILVER; GOLD; COPPER; EUGENOL; FORMALDEHYDE; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; TIN; TITANIUM; ZINC 3; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0945_6250548b-6163-4894-b9c2-d17c64341c42 43742-0945 HUMAN OTC DRUG Radiation Plus Chondrus Crispus, Fucus Vesiculosus, Thyroidinum (Suis), Cadmium Iodatum, Cadmium Sulphuratum, Iodium, Radium Bromatum, Strontium Carbonicum, Uranium Nitricum, X-Ray, Arnica Montana LIQUID ORAL 20161228 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHONDRUS CRISPUS; FUCUS VESICULOSUS; SUS SCROFA THYROID; CADMIUM IODIDE; CADMIUM SULFIDE; IODINE; RADIUM BROMIDE; STRONTIUM CARBONATE; URANYL NITRATE HEXAHYDRATE; ALCOHOL, X-RAY EXPOSED (1000 RAD); ARNICA MONTANA 3; 3; 8; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0946_d14f2914-c0a4-4c81-96f1-0d5189feb8ba 43742-0946 HUMAN OTC DRUG Arthritis/Joints Gnaphalium Polycephalum, Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Borax, Cuprum Aceticum, Kali Carbonicum, Pulsatilla (Vulgaris), Secale Cornutum, Ammonium Muriaticum, Silicea, Argentum Metallicum, Calcarea Phosphorica, Glandula Suprarenalis Suis, Mercurius Praecipitatus Ruber, Sepia, Zincum Metallicum, Palladium Metallicum, Picricum Acidum, Sulphur, Cartilago Suis, Discus Intervertebralis Suis, Medulla Ossis Suis LIQUID ORAL 20161228 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PSEUDOGNAPHALIUM OBTUSIFOLIUM; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; SODIUM BORATE; CUPRIC ACETATE; POTASSIUM CARBONATE; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM; AMMONIUM CHLORIDE; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA ADRENAL GLAND; MERCURIC OXIDE; SEPIA OFFICINALIS JUICE; ZINC; PALLADIUM; PICRIC ACID; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA BONE MARROW 3; 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 8; 8; 10; 10; 10; 10; 10; 10; 12; 12; 30; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0947_79302677-dfcd-4013-b4f3-223185520ddd 43742-0947 HUMAN OTC DRUG Headache Cimicifuga Racemosa, Gelsemium Sempervirens, Rhus Tox LIQUID ORAL 20161228 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF 2; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0948_5469c7c4-2047-447e-8970-9891c087726d 43742-0948 HUMAN OTC DRUG Healing Support Betula (Pendula) Cortex, Caltha Palustris, Galium Aparine, Sedum Acre, Thuja Occidentalis, Urtica Urens, Clematis Erecta, Hedera Helix, Juniperus Communis, Quillaja Saponaria, Sempervivum Tectorum, Echinacea (Angustifolia), Nitricum Acidum, Argentum Metallicum, Calcarea Fluorica, Phosphorus, Apis Mellifica, Pyrogenium, Ononis Spinosa LIQUID ORAL 20161229 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETULA PENDULA BARK; CALTHA PALUSTRIS; GALIUM APARINE; SEDUM ACRE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; CLEMATIS RECTA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; QUILLAJA SAPONARIA BARK; SEMPERVIVUM TECTORUM LEAF; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; SILVER; CALCIUM FLUORIDE; PHOSPHORUS; APIS MELLIFERA; RANCID BEEF; ONONIS SPINOSA WHOLE 1; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 12; 12; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0949_6aec5184-56dd-44a7-ad8a-f90284b97a50 43742-0949 HUMAN OTC DRUG Lymphoplus Trifolium Pratense, Lymph Node (Suis), Spleen (Suis), Conium Maculatum, Echinacea (Angustifolia), Lycopodium Clavatum, Myrrha, Phytolacca Decandra, Selenium Metallicum, Silicea LIQUID ORAL 20161229 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TRIFOLIUM PRATENSE FLOWER; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHYTOLACCA AMERICANA ROOT; SELENIUM; SILICON DIOXIDE 3; 8; 8; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0950_985fc77b-3d5c-446b-a931-3cad8cfead33 43742-0950 HUMAN OTC DRUG Heart Small Intestine Meridian Opener Arsenicum Album, Aurum Metallicum, Belladonna, Cactus Grandiflorus, Cinchona Officinalis, Digitalis Purpurea, Kali Carbonicum, Lithium Carbonicum, Lycopodium Clavatum, Mercurius Solubilis, Naja Tripudians, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris), Pyrogenium, Spigelia Anthelmia LIQUID ORAL 20161229 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; GOLD; ATROPA BELLADONNA; SELENICEREUS GRANDIFLORUS STEM; CINCHONA OFFICINALIS BARK; DIGITALIS; POTASSIUM CARBONATE; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; RANCID BEEF; SPIGELIA ANTHELMIA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0951_fe2261c4-03c0-4329-acb6-ce1c0cee3966 43742-0951 HUMAN OTC DRUG Norepinephrine Norepinephrine LIQUID ORAL 20161230 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. NOREPINEPHRINE 6 [hp_X]/mL N 20191231 43742-0952_e7350d02-a75f-4771-90b6-5eaaafd548fa 43742-0952 HUMAN OTC DRUG Candida Candida Albicans LIQUID ORAL 20161230 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CANDIDA ALBICANS 200 [hp_C]/mL N 20181231 43742-0953_f5e77d7d-ad57-4fec-8a5f-50da2b3c376b 43742-0953 HUMAN OTC DRUG Immune Support Echinacea (Angustifolia), Aconitum Napellus, Arnica Montana, Baptisia Tinctoria, Rhus Tox, Sanguinaria Canadensis, Aristolochia Clematitis, Bryonia (Alba), Eupatorium Perfoliatum, Euphorbium Officinarum, Gelsemium Sempervirens, Mercurius Corrosivus, Phytolacca Decandra, Argentum Nitricum, Arsenicum Album, Phosphorus, Pulsatilla (Vulgaris), Sulphur, Thuja Occidentalis, Hepar Sulphuris Calcareum, Lachesis Mutus, Zincum Metallicum, Astragalus Menziesii, Belladonna, Influenzinum (2016-2017), Spleen (Suis) LIQUID ORAL 20161230 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; ACONITUM NAPELLUS; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; ARISTOLOCHIA CLEMATITIS ROOT; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; MERCURIC CHLORIDE; PHYTOLACCA AMERICANA ROOT; SILVER NITRATE; ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; CALCIUM SULFIDE; LACHESIS MUTA VENOM; ZINC; ASTRAGALUS NUTTALLII LEAF; ATROPA BELLADONNA; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); SUS SCROFA SPLEEN; SUS SCROFA THYMUS; VISCUM ALBUM FRUITING TOP; CORTISONE ACETATE; RANCID BEEF 1; 3; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12; 12; 13; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0954_f6f3bd02-bf24-4aa8-a699-5e81d84ae9de 43742-0954 HUMAN OTC DRUG Neuro I Taraxacum Officinale, Hydrastis Canadensis, Dopamine Hydrochloride, L-Dopa, Melatonin, Serotonin (Hydrochloride) LIQUID ORAL 20170103 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TARAXACUM OFFICINALE; GOLDENSEAL; DOPAMINE HYDROCHLORIDE; LEVODOPA; MELATONIN; SEROTONIN HYDROCHLORIDE 3; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0955_7c431149-4f46-4c4f-a5bb-c1b1fb705283 43742-0955 HUMAN OTC DRUG Levothyroxine Levothyroxine LIQUID ORAL 20170106 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LEVOTHYROXINE 16 [hp_X]/mL N 20181231 43742-0956_b6623987-a01b-4884-8c39-e6e1239cfa0c 43742-0956 HUMAN OTC DRUG Liothyronine Liothyronine Sodium LIQUID ORAL 20170106 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LIOTHYRONINE SODIUM 10 [hp_X]/mL N 20181231 43742-0957_0d50a133-44f6-433f-9cf5-aeb762b3a773 43742-0957 HUMAN OTC DRUG Enviroclenz Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Stillingia Sylvatica, Taraxacum Officinale, Trifolium Pratense, Germanium Sesquioxide, Benzinum, Chlorinum, Acetone, Ammonium Muriaticum, Propylene Glycol, Sodium Benzene Sulfonate, Sodium Lauryl Sulfate, Sodium Tripolyphosphate, Terebinthina, Methanol, Belladonna, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20170106 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; STILLINGIA SYLVATICA ROOT; TARAXACUM OFFICINALE FLOWERING TOP; TRIFOLIUM PRATENSE LEAF; GERMANIUM SESQUIOXIDE; BENZENE; CHLORINE; ACETONE; AMMONIUM CHLORIDE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; TURPENTINE OIL; METHYL ALCOHOL; ATROPA BELLADONNA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0958_db85fcb3-c752-4bd7-9ff6-635e8537125d 43742-0958 HUMAN OTC DRUG Upper Respiratory Staph Strep Combination Staphylococcus Aureus, Klebsiella Pneumoniae, Enterococcus Faecalis, Pneumococcinum, Streptococcus Agalactiae, Streptococcus Mutans, Haemophilus Influenzae B, Streptococcus Viridans LIQUID ORAL 20170106 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. STAPHYLOCOCCUS AUREUS; KLEBSIELLA PNEUMONIAE; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS MUTANS; HAEMOPHILUS INFLUENZAE TYPE B; STREPTOCOCCUS VIRIDANS GROUP 15; 15; 12; 12; 12; 12; 12; 36 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0959_fc8be209-bbb9-4b0d-8bbd-7dd7a28c913f 43742-0959 HUMAN OTC DRUG Stomach Spleen Meridian Opener Arsenicum Album, Calcarea Carbonica, Carduus Marianus, Ceanothus Americanus, Cinchona Officinalis, Digitalis Purpurea, Ignatia Amara, Kali Bichromicum, Lycopodium Clavatum, Phosphorus, Plumbum Metallicum, Pulsatilla (Vulgaris), Ranunculus Bulbosus, Veratrum Viride LIQUID ORAL 20170106 UNAPPROVED HOMEOPATHIC Desert Biologicals, Inc. ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILYBUM MARIANUM SEED; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; DIGITALIS; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; LEAD; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; VERATRUM VIRIDE ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0960_b9ad6376-ef58-474e-b87a-97c4933f2a64 43742-0960 HUMAN OTC DRUG Virus Plus Influenzinum (2016-2017), Adenoviren Nosode, Herpes Simplex 1 Nosode, Herpes Simplex 2 Nosode, Cytomegalovirus Nosode, Epstein-Barr Virus Nosode, Hepatitis B Nosode, Norovirus Nosode LIQUID ORAL 20170106 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ANTIGEN; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4; HEPATITIS B VIRUS; NORWALK VIRUS 12; 12; 12; 15; 15; 15; 15; 18; 18; 33; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0961_334a2e76-b11f-40f6-adda-59e70fad813c 43742-0961 HUMAN OTC DRUG HGH Vitality Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-Dopa, Melatonin, Testosterone, Adenosinum Triphosphoricum Dinatrum, Alpha-Lipoicum Acidum, Nadidum, Pantothenic Acid, Sarcolacticum Acidum, Ubidecarenonum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (Suis), Lymph Node (Suis), Medulla Ossis Suis, Oophorinum (Suis), Orchitinum (Suis), Pancreas Suis, Spleen (Suis), Human Growth Hormone TABLET ORAL 20170110 UNAPPROVED HOMEOPATHIC Deseret Biologicals CHASTE TREE; AMBERGRIS; CONIUM MACULATUM FLOWERING TOP; APIOLE (PARSLEY); ESTRADIOL; ESTRIOL; ESTRONE; LEVODOPA; MELATONIN; TESTOSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; .ALPHA.-LIPOIC ACID; NADIDE; PANTOTHENIC ACID; LACTIC ACID, L-; UBIDECARENONE; BARIUM CARBONATE; SELENIUM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SOMATROPIN; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 N 20181231 43742-0962_762ea8c4-e202-4e67-90bd-8856c7f131f1 43742-0962 HUMAN OTC DRUG Rocky Mountain Spotted Fever Homochord Rickettsia Prowazekii LIQUID ORAL 20170109 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. RICKETTSIA PROWAZEKII 10 [hp_C]/mL N 20181231 43742-0963_ec444d44-a505-4eda-89d8-98dc61839cfb 43742-0963 HUMAN OTC DRUG Trauma Relief Chamomilla, Echinacea (Angustifolia), Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Bryonia (Alba), Calendula Officinalis, Arnica Montana, Belladonna, Bellis Perennis, Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos, Symphytum Officinale, Rhus Tox, Hepar Sulphuris Calcareum, Carbo Vegetabilis GEL TOPICAL 20170120 20220918 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; COMFREY ROOT; TOXICODENDRON PUBESCENS LEAF; CALCIUM SULFIDE; ACTIVATED CHARCOAL 3; 3; 3; 3; 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43742-0969_3ab8242d-130c-4a83-8672-97ee81b352b6 43742-0969 HUMAN OTC DRUG Human Parvovirus Homochord Parvovirus Nosode LIQUID ORAL 20170208 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HUMAN PARVOVIRUS B19 15 1/mL N 20181231 43742-0970_85f2eb31-a973-43b2-b161-5e80f662405b 43742-0970 HUMAN OTC DRUG Biological Complex I Variolinum LIQUID ORAL 20170208 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 30 [hp_C]/mL N 20181231 43742-0973_f3f6cd08-12ba-478f-bc85-d427624494f2 43742-0973 HUMAN OTC DRUG Phenyl Isothiocyanate Phenyl Isothiocyanate LIQUID ORAL 20170209 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PHENYL ISOTHIOCYANATE 6 [hp_X]/mL N 20181231 43742-0974_4e81cc28-d191-4dd4-8feb-7913991a9d99 43742-0974 HUMAN OTC DRUG Female Stimulant Aquilegia Vulgaris, Lilium Tigrinum, Bovista, Cypripedium Pubescens, Hydrastis Canadensis, Apiolum, Apis Venenum Purum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Heart (Suis), Kreosotum, Oophorinum (Suis), Uterus (Suis), Folliculinum, Aconiticum Acidum, CIS-, Lachesis Mutus, Magnesia Phosphorica, Mercurius Solubilis, Sepia, Pineal Gland (Suis), Hypophysis Suis, Estradiol, Progesterone, Testosterone, Placenta Totalis Suis, Bacillus Faecalis, Mutabile Bacillus (Bach) LIQUID ORAL 20170804 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AQUILEGIA VULGARIS; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPERDON UTRIFORME FRUITING BODY; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; GOLDENSEAL; APIOLE (PARSLEY); APIS MELLIFERA VENOM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK HEART; WOOD CREOSOTE; SUS SCROFA OVARY; SUS SCROFA UTERUS; ESTRONE; ACONITIC ACID, (Z)-; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; SEPIA OFFICINALIS JUICE; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; ESTRADIOL; PROGESTERONE; TESTOSTERONE; SUS SCROFA PLACENTA; ALCALIGENES FAECALIS; ESCHERICHIA COLI 4; 4; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 12; 13; 30; 30; 30; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0975_0ee42824-189b-435a-88de-bd0f4c71ca37 43742-0975 HUMAN OTC DRUG Octopamine Octopamine (Hydrochloride) LIQUID ORAL 20170216 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. OCTOPAMINE HYDROCHLORIDE 6 [hp_X]/mL N 20181231 43742-0976_e712ffb5-4b08-4fd3-89de-f2fcdeb4fa5d 43742-0976 HUMAN OTC DRUG Heart/Fatigue Kali Carbonicum, Arnica Montana, Cactus Grandiflorus, Gelsemium Sempervirens, Castoreum, Glonoinum, Ranunculus Bulbosus, Spigelia Anthelmia, Heart (Suis), Abrotanum, Sulphur LIQUID ORAL 20170216 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. POTASSIUM CARBONATE; ARNICA MONTANA; SELENICEREUS GRANDIFLORUS STEM; GELSEMIUM SEMPERVIRENS ROOT; CASTOR CANADENSIS SCENT GLAND SECRETION; NITROGLYCERIN; RANUNCULUS BULBOSUS; SPIGELIA ANTHELMIA; PORK HEART; ARTEMISIA ABROTANUM FLOWERING TOP; SULFUR 3; 4; 4; 4; 6; 6; 6; 6; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0977_6048916f-3d02-443e-a374-3ee70774d333 43742-0977 HUMAN OTC DRUG Allermilk Taraxacum Officinal, Hydrastis Canadensis, Apiolum, Asparagine, Benzoicum Acidum, Cholinum, Cinnamic Acid, Coumarinum, Eugenol, Folic Acid, Folliculinum, Formalinum, GABA (Gamma-Aminobutyric Acid), Histaminum Hydrochloricum, Menadione, Octopamine (Hydrochloride), Oophorinum (Suis), Phenyl Isothiocyanate, Piperine, Progesterone, Quercetin, Rutin, Saccharum Lactis, Vanillylamine, Xanthine LIQUID ORAL 20170217 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TARAXACUM OFFICINALE; GOLDENSEAL; APIOLE (PARSLEY); ASPARAGINE; BENZOIC ACID; CHOLINE; CINNAMIC ACID; COUMARIN; EUGENOL; FOLIC ACID; ESTRONE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE DIHYDROCHLORIDE; MENADIONE; OCTOPAMINE HYDROCHLORIDE; SUS SCROFA OVARY; PHENYL ISOTHIOCYANATE; PIPERINE; PROGESTERONE; QUERCETIN; RUTIN; LACTOSE, UNSPECIFIED FORM; VANILLYLAMINE; XANTHINE 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0984_57446528-a8f5-4a67-bb3c-2f659be67d1c 43742-0984 HUMAN OTC DRUG Rheumagesic Arnica Montana, Apis Mellifica, Benzoicum Acidum, Cartilago Suis, Ledum Palustre, Pantothenic Acid, Rhododendron Chrysanthum, Ruta Graveolens, Causticum, Formica Rufa, Sepia, alpha-Lipoicum Acidum, Aurum Metallicum, Calcarea Phosphorica, Phytolacca Decandra, Radium Bromatum, Rhus Venenata, Thuja Occidentalis, Lac Caninum LIQUID ORAL 20170221 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; APIS MELLIFERA; BENZOIC ACID; SUS SCROFA CARTILAGE; RHODODENDRON TOMENTOSUM LEAFY TWIG; PANTOTHENIC ACID; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; CAUSTICUM; FORMICA RUFA; SEPIA OFFICINALIS JUICE; THIOCTIC ACID; GOLD; TRIBASIC CALCIUM PHOSPHATE; COLCHICUM AUTUMNALE BULB; PHYTOLACCA AMERICANA ROOT; RADIUM BROMIDE; TOXICODENDRON VERNIX LEAFY TWIG; THUJA OCCIDENTALIS LEAFY TWIG; CANIS LUPUS FAMILIARIS MILK 3; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12; 12; 16 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0985_fb43f2a5-484e-4f51-ad6f-8d35a5116c6d 43742-0985 HUMAN OTC DRUG Candida Candida Albicans LIQUID ORAL 20170221 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CANDIDA ALBICANS 200 [hp_C]/mL N 20181231 43742-0986_a3526c49-d36a-4d4e-9506-60eb91dd6252 43742-0986 HUMAN OTC DRUG Chronagesic Arnica Montana, Cartilago Suis, Cinnamomum, Dulcamara, Funiculus Umbilicalis Suis, Nadidum, Natrum Oxalaceticum, Pantothenic Acid, Placenta Totalis Suis, Rhus Tox, Sanguinaria Canadensis, Sulphur, Apiolum, Piper Nigrum, Alpha-Lipoicum Acidum, Silicea, Symphytum Officinale, Thuja Occidentalis LIQUID ORAL 20170228 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARNICA MONTANA; SUS SCROFA CARTILAGE; CINNAMON; SOLANUM DULCAMARA TOP; SUS SCROFA UMBILICAL CORD; NADIDE; SODIUM DIETHYL OXALACETATE; PANTOTHENIC ACID; SUS SCROFA PLACENTA; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; APIOLE (PARSLEY); GREEN PEPPERCORN; .ALPHA.-LIPOIC ACID; SILICON DIOXIDE; COMFREY ROOT; THUJA OCCIDENTALIS LEAFY TWIG 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0987_1918b06b-9e82-44b3-8947-738ec6a7895c 43742-0987 HUMAN OTC DRUG Systemic Detox Beta Vulgaris, Boldo, Chelidonium Majus, Sarsaparilla (Smilax Regelii), Gelsemium Sempervirens, Veratrum Album, Ferrum Metallicum, Iodium, Lycopodium Clavatum, Nux Vomica, Pulsatilla (Vulgaris), Selenium Metallicum, Thuja Occidentalis, Zincum Metallicum LIQUID ORAL 20170303 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; SARSAPARILLA; GELSEMIUM SEMPERVIRENS ROOT; VERATRUM ALBUM ROOT; IRON; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SELENIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 3; 3; 3; 6; 7; 7; 12; 12; 12; 12; 12; 12; 12; 12 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL N 20181231 43742-0988_33c2aa4c-f311-4822-9a4a-b5407961985c 43742-0988 HUMAN OTC DRUG HGH Vitality Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-Dopa, Melatonin, Testosterone, Adenosinum Triphosphoricum Dinatrum, Alpha-Lipoicum Acidum, Nadidum, Pantothenic Acid, Sarcolacticum Acidum, Ubidecarenonum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (Suis), Lymph Node (Suis), Medulla Ossis Suis, Oophorinum (Suis), Orchitinum (Suis), Pancreas Suis, Spleen (Suis), Human Growth Hormone LIQUID ORAL 20170303 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHASTE TREE; AMBERGRIS; CONIUM MACULATUM FLOWERING TOP; APIOLE (PARSLEY); ESTRADIOL; ESTRIOL; ESTRONE; LEVODOPA; MELATONIN; TESTOSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; .ALPHA.-LIPOIC ACID; NADIDE; PANTOTHENIC ACID; LACTIC ACID, L-; UBIDECARENONE; BARIUM CARBONATE; SELENIUM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SOMATROPIN; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-0989_4bf7217c-217b-425b-9de2-4bfe9c3ef7f9 43742-0989 HUMAN OTC DRUG Pertussis Aconitum Napellus, Belladonna, Bryonia (Alba), Hyoscyamus Niger, Ipecacuanha, Sticta Pulmonaria, Tabacum, Phosphorus, Antimonium Tartaricum, Kreosotum, Silicea, Pertussinum, Tetanus Toxin LIQUID ORAL 20170308 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; HYOSCYAMUS NIGER; IPECAC; LOBARIA PULMONARIA; TOBACCO LEAF; PHOSPHORUS; ANTIMONY POTASSIUM TARTRATE; WOOD CREOSOTE; SILICON DIOXIDE; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; CLOSTRIDIUM TETANI 4; 4; 4; 4; 4; 4; 4; 5; 6; 6; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0990_673d28bf-1433-458f-be43-30c65336ac0f 43742-0990 HUMAN OTC DRUG Influenza Plus Eucalyptus Globulus, Ipecacuanha, Aconitum Napellus, Influenzinum, Respiratory Syncytial Virus Nosode (RSV), Belladonna, Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Kreosotum, Veratrum Viride LIQUID ORAL 20170309 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EUCALYPTUS GLOBULUS LEAF; IPECAC; ACONITUM NAPELLUS; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN); ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; WOOD CREOSOTE; VERATRUM VIRIDE ROOT 2; 3; 3; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0991_e056c4ab-43eb-46dc-a1a4-e2f5b90fdeb3 43742-0991 HUMAN OTC DRUG Biological Complex II Anthracinum LIQUID ORAL 20170309 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 30 [hp_C]/mL N 20181231 43742-0992_907cd817-fa8d-4d18-870a-7f3f484a5307 43742-0992 HUMAN OTC DRUG ENT Support Pulsatilla (Vulgaris), Euphorbium Officinarum, Luffa Operculata, Mercurius Iodatus Ruber, Argentum Nitricum, Hepar Sulphuris Calcareum, Influenzinum (2016-2017), Sinusitisinum, Aspergillus Niger, Candida Albicans, Gallicum Acidum, Mucor Racemosus, Mutabile Bacillus (Bach) LIQUID ORAL 20170314 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PULSATILLA VULGARIS; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SILVER NITRATE; CALCIUM SULFIDE; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); SINUSITISINUM; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; GALLIC ACID MONOHYDRATE; MUCOR RACEMOSUS; ESCHERICHIA COLI 2; 6; 6; 8; 10; 10; 11; 11; 11; 17; 10; 10; 10; 10; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-0996_a4c865a6-ead8-4615-ac1e-b8a6050f8942 43742-0996 HUMAN OTC DRUG Leaky Gut Formula Alfalfa, Aloe, Fragaria Vesca, Glycyrrhiza, Astacus Fluviatilis, Berberis Aquifolium, Lac Defloratum, Natrum Carbonicum, Saccharum Officinale, Fel Tauri, Pancreas Suis, Pepsinum, Antimonium Crudum, Carbo Vegetabilis, Euphorbium Officinarum, Lycopodium Clavatum, Magnesia Carbonica, Zincum Metallicum, Colibacillinum Cum Natrum Muriaticum, Proteus (Mirabilis) LIQUID ORAL 20170317 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ALFALFA; ALOE; ALPINE STRAWBERRY; GLYCYRRHIZA GLABRA; ASTACUS ASTACUS; BERBERIS AQUIFOLIUM ROOT BARK; SKIM MILK; SODIUM CARBONATE; SUCROSE; BOS TAURUS BILE; SUS SCROFA PANCREAS; PEPSIN; ANTIMONY TRISULFIDE; ACTIVATED CHARCOAL; EUPHORBIA RESINIFERA RESIN; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; ZINC; ESCHERICHIA COLI; PROTEUS MIRABILIS 3; 3; 3; 3; 6; 6; 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-0998_ef9ca963-405e-4e98-9610-92cfd983c1ec 43742-0998 HUMAN OTC DRUG Perfect Sleep Adenosinum Triphosphoricum Dinatrum, Pantothenic Acid, Ubidecarenonum, Pineal Gland (Suis), Sarcolacticum Acidum, Melatonin, Pyrrole, Tryptophan, Arsenicum Album, Avena Sativa, Chamomilla, Coffea Cruda, Mercurius Corrosivus, Passiflora Incarnata, Silicea, Zincum Valerianicum, Dysentery Bacillus, Gaertner Bacillus LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; PANTOTHENIC ACID; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; UBIDECARENONE; MELATONIN; PYRROLE; TRYPTOPHAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE; ZINC VALERATE DIHYDRATE; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1 N 20181231 43742-0999_ad4bf842-eb50-4335-be2d-98f8c521fe8e 43742-0999 HUMAN OTC DRUG Chlorogenic Acid Chlorogenic Acid LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHLOROGENIC ACID 6 [hp_X]/mL N 20181231 43742-1000_21adf390-c435-481d-af82-4c73e74872fe 43742-1000 HUMAN OTC DRUG Sore Throat Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla (Smilax Regelii), Calcarea Phosphorica, Ferrum Iodatum, Lymph Nose (Suis), Throidinum (Suis) LIQUID ORAL 20170421 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; ARANEUS DIADEMATUS; SMILAX ORNATA ROOT; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA LYMPH; SUS SCROFA THYROID 3; 3; 3; 3; 4; 4; 4; 4; 4; 5; 5; 5; 6; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1002_71a28036-6fc1-4651-b0ee-79e92ae4a7aa 43742-1002 HUMAN OTC DRUG Giardia Lamblia Homochord Giardia Lamblia LIQUID ORAL 20170501 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc GIARDIA LAMBLIA 11 [hp_C]/mL N 20181231 43742-1005_09fbf775-63ff-4c5a-a3a8-247dce6e4df6 43742-1005 HUMAN OTC DRUG Sinusitis Pulsatilla (Vulgaris), Plantago Major, Euphorbium Officinarum, Luffa Operculata, Mercurius Iodatus Ruber, Mucosa Nasalis Suis, Argentum Nitricum, Hepar Sulphuris Calcareum, Calcarea Carbonica, Natrum Muriaticum, Sinusitisinum LIQUID ORAL 20170502 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PULSATILLA VULGARIS; PLANTAGO MAJOR; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SUS SCROFA NASAL MUCOSA; EUPHORBIA RESINIFERA RESIN; SILVER NITRATE; CALCIUM SULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; SINUSITISINUM 1; 3; 3; 6; 8; 8; 9; 10; 10; 12; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1006_baa7839f-9cd8-4bf3-8c99-0804713ab7e2 43742-1006 HUMAN PRESCRIPTION DRUG Rheumatism Benzoicum Acidum, Pulsatilla (Vulgaris), Rhododendron Chrysanthum, Spiraea Ulmaria, Aconitum Napellus, Dulcamara, Ledum Palustre, Asclepias Tuberosa, Lithium Benzoicum, Euphorbium Officinarum LIQUID ORAL 20170504 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BENZOIC ACID; ANEMONE PULSATILLA; RHODODENDRON AUREUM LEAF; FILIPENDULA ULMARIA ROOT; ACONITUM NAPELLUS; SOLANUM DULCAMARA TOP; RHODODENDRON TOMENTOSUM LEAFY TWIG; ASCLEPIAS TUBEROSA ROOT; LITHIUM BENZOATE; EUPHORBIA RESINIFERA RESIN 3; 3; 3; 3; 4; 4; 4; 6; 8; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Mood Stabilizer [EPC] N 20181231 43742-1007_c03a06a4-9590-4a86-adad-e5f18ff90d58 43742-1007 HUMAN OTC DRUG Tyramine Tyramine LIQUID ORAL 20170501 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TYRAMINE 6 [hp_X]/mL N 20181231 43742-1008_7318736c-ba26-4c58-b425-89f464a5ee21 43742-1008 HUMAN OTC DRUG GI Drainage Cinnamomum, Gentiana Lutea, Syzygium Jambolanum, Argentum Nitricum, Colchicum Autumnale, Colostrum, Copper Gluconate, Lappa Major, Lycopodium Clavatum, Magnesium Gluconate, Manganese Gluconate, Nitricum Acidum, Pancreas Suis, Potassium Gluconate, Rumex Crispus, Schrophu8laria Nodosa, Stomach (Suis), Aurum Metallicum, Beech, Calcarea Carbonica, Carbo Vegetabilis, Cherry Plum, Crab Apple, Intestine (Suis), Rock Water, Fagus Sylvatica, Flos LIQUID ORAL 20170519 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CINNAMON; GENTIANA LUTEA ROOT; SYZYGIUM CUMINI SEED; SILVER NITRATE; COLCHICUM AUTUMNALE BULB; BOS TAURUS COLOSTRUM; COPPER GLUCONATE; ARCTIUM LAPPA ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; NITRIC ACID; SUS SCROFA PANCREAS; POTASSIUM GLUCONATE; RUMEX CRISPUS ROOT; SCROPHULARIA NODOSA; SUS SCROFA STOMACH; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; PORK INTESTINE; MALUS PUMILA FLOWER; PRUNUS CERASIFERA FLOWER; FAGUS SYLVATICA FLOWERING TOP 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1009_deeeed11-b3a9-40b8-9c04-adff569bb805 43742-1009 HUMAN OTC DRUG Heart Small Intestine Meridian Opener Arsenicum Album, Aurum Metallicum, Cactus Grandiflorus, Cinchona Officinalis, Digitalis Purpurea, Kali Carbonicum, Lithium Carbonicum, Lycopodium Clavatum, Mercurius Solubilis, Naja Tripudians, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris), Pyrogenium, Spigelia Anthelmia LIQUID ORAL 20170525 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ARSENIC TRIOXIDE; GOLD; SELENICEREUS GRANDIFLORUS STEM; CINCHONA OFFICINALIS BARK; DIGITALIS; POTASSIUM CARBONATE; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE PULSATILLA; RANCID BEEF; SPIGELIA ANTHELMIA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-1010_eb6cb15a-3b60-4744-928d-3e4029186244 43742-1010 HUMAN OTC DRUG Thyroplus Fucus Vesiculosus, Spongia Tosta, Phosphoricum Acidum, Hypophysis (Suis), Thyroidinum (Suis), Calcarea Carbonica, Iodium, Iridium Metallicum LIQUID ORAL 20170809 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; IRIDIUM 3; 4; 6; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1011_2eed39d0-88ce-4539-a9e2-41d5374ce699 43742-1011 HUMAN OTC DRUG Governing Vessel Conception Vessel Meridian Opener Apis Mellifica, Arsenicum Album, Baryta Carbonica, Calcarea Carbonica, Cicuta Virosa, Conium Maculatum, Ferrum Metallicum, Lachesis Mutus, Lycopodium Clavatum, Mercurius Solubilis, Natrum Sulphuricum, Phosphorus, Pulsatilla (Vulgaris), Sepia, Tarentula Hispana, Thuja Occidentalis LIQUID ORAL 20170515 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CICUTA VIROSA ROOT; CONIUM MACULATUM FLOWERING TOP; IRON; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; LYCOSA TARANTULA; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-1012_b1f8ad1f-4676-42a8-91a8-20fe2f9d4571 43742-1012 HUMAN OTC DRUG Chlamydia Homochord Chlamydia Trachomatis LIQUID ORAL 20170525 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CHLAMYDIA TRACHOMATIS 12 [hp_X]/mL N 20181231 43742-1015_226680c4-9ec4-4bbf-911b-ae4124e352db 43742-1015 HUMAN OTC DRUG Upper Respiratory Staph/Strep Combination Staphylococcus Aureus, Klebsiella Pneumoniae, Enterococcus Faecalis, Pneumococcinum, Streptococcus Agalactiae, Streptococcus Mutans, Haemophilus Influenzae B, Streptococcus Viridans TABLET ORAL 20170531 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. STAPHYLOCOCCUS AUREUS; KLEBSIELLA PNEUMONIAE; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS MUTANS; HAEMOPHILUS INFLUENZAE TYPE B; STREPTOCOCCUS VIRIDANS GROUP 15; 15; 12; 12; 12; 12; 12; 36 [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 43742-1016_b3dcf7a9-9741-4133-bd5a-f7467cf93935 43742-1016 HUMAN OTC DRUG Bio Co-Enzyme Phase Beta Vulgaris, Ascorbicum Acidum, Cysteinum, Natrum Oxalaceticum, Nicotinamidum, Pulsatilla (Vulgaris), Pyridoxinum, Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Adrenalinum, Aconiticum Acidum, Cis-, alpha-Ketoglutaricum Acidum, alpha-Lipoicum Acidum, Cerium Oxalicum, Citricum Acidum, Fumaricum Acidum, Magnesium Oroticum Dihydricum, Malicum Acidum, Nadidum, Natrum Pyruvicum, Pantothenic Acid, Succinicum Acidum, Adenosinum Triphosphoricum Dinatrum, Hepar Sulphuris Calcareum, Sulphur LIQUID ORAL 20170531 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; ASCORBIC ACID; CYSTEINE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; ANEMONE PULSATILLA; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; EPINEPHRINE; ACONITIC ACID, (Z)-; OXOGLURIC ACID; THIOCTIC ACID; CEROUS OXALATE NONAHYDRATE; ANHYDROUS CITRIC ACID; FUMARIC ACID; MAGNESIUM OROTATE DIHYDRATE; MALIC ACID; NADIDE; SODIUM PYRUVATE; PANTOTHENIC ACID; SUCCINIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; CALCIUM SULFIDE; SULFUR; MANGANESE PHOSPHATE, DIBASIC; BARIUM OXALOSUCCINATE; PROTEUS MORGANII 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 16; 30; 34 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-1017_c52d041c-ac54-49b2-8140-f470b4a2f592 43742-1017 HUMAN OTC DRUG Skin Infections Ailanthus Glandulosus, Echinacea (Angustifolia), Phytolacca Decandra, Hepar Sulphuris Calcareum, Mercurius Solubilis, Mezereum, Arsenicum Album, Lachesis Mutus, Herpes Simplex 1 and 2 Nosode, Herpes Zoster Nosode LIQUID ORAL 20180116 UNAPPROVED HOMEOPATHIC Deseret Biologials, Inc. AILANTHUS ALTISSIMA FLOWERING TWIG; ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; ARSENIC TRIOXIDE; LACHESIS MUTA VENOM; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 3 3; 3; 4; 8; 8; 9; 12; 12; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 43742-1018_cef9eab3-8cc3-4580-80b3-93e3ca2a1db5 43742-1018 HUMAN OTC DRUG Pre-Dental Visit Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Arvense, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Sarsaparilla (Smilax Regelii), Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos, Myosotis Arvensis, Aranea Diadema, Calcarea Phosphorica, Ferrum Iodatum, Lymph Node (Suis), Thyroidinum (Suis) LIQUID ORAL 20180116 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM ARVENSE TOP; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; SARSAPARILLA; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; MYOSOTIS ARVENSIS; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA LYMPH; SUS SCROFA THYROID 3; 3; 3; 4; 4; 4; 4; 4; 4; 5; 5; 5; 6; 8; 8; 8; 8; 8; 9; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 43742-1019_267f36d4-6003-4ed9-b9d2-e248003d1eba 43742-1019 HUMAN OTC DRUG Upper Respiratory Support Allium Cepa, Echinacea (Angustifolia), Eucalyptus Globulus, Salvia Officinalis, Dulcamara, Euphrasia Officinalis, Hydrastis Canadensis, Natrum Muriaticum, Sabadilla, Viscum Album, Mucosa Nasalis Suis, Aconitum Napellus, Ammonium Carbonicum, Arsenicum Iodatum, Bryonia (Alba), Gelsemium Sempervirens, Kali Bichromicum, Mercurius Vivus, Nux Vomica, Pulsatilla (Pratensis), Rhus Tox LIQUID ORAL 20170606 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ONION; ECHINACEA ANGUSTIFOLIA; EUCALYPTUS GLOBULUS LEAF; SAGE; SOLANUM DULCAMARA TOP; EUPHRASIA STRICTA; GOLDENSEAL; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; VISCUM ALBUM FRUITING TOP; SUS SCROFA NASAL MUCOSA; ACONITUM NAPELLUS; AMMONIUM CARBONATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; MERCURY; STRYCHNOS NUX-VOMICA SEED; ANEMONE PRATENSIS; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1031_529cc14c-8467-492f-8f16-e6f4ef71d4d8 43742-1031 HUMAN OTC DRUG Headache Cimicifuga Racemosa, Gelsemium Sempervirens, Rhus Tox LIQUID ORAL 20170619 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF 1; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1032_3654bd9c-4e50-4c1f-844c-dfde9115962e 43742-1032 HUMAN OTC DRUG Ver Filix Mas, Artemisia Vulgaris, Cina, Melilotus Officinalis, Quassia (Amara), Spigelia Anthelmia, Teucrium Marum, Thymus Serpyllum, Silicea, Calcarea Carbonica, Graphites, Iodium, Mercurius Corrosivus, Sabadilla, Ascaris Lumbricoides, Trichinella Spiralis, Enterobius Vermicularis, Taenia Solium, Trichomonas Vaginalis, Giardia Lamblia, Cryptosporidium Parvum, Taenia Saginata, Brugia Malayi LIQUID ORAL 20170622 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DRYOPTERIS FILIX-MAS ROOT; ARTEMISIA VULGARIS ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; MELILOTUS OFFICINALIS TOP; QUASSIA AMARA WOOD; TEUCRIUM MARUM; THYMUS SERPYLLUM; SPIGELIA ANTHELMIA; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; IODINE; MERCURIC CHLORIDE; SCHOENOCAULON OFFICINALE SEED; ASCARIS LUMBRICOIDES; TRICHINELLA SPIRALIS; ENTEROBIUS VERMICULARIS; TAENIA SOLIUM; TRICHOMONAS VAGINALIS; GIARDIA LAMBLIA; CRYPTOSPORIDIUM PARVUM; TAENIA SAGINATA; BRUGIA MALAYI 1; 2; 3; 3; 3; 3; 3; 6; 8; 12; 12; 12; 12; 12; 15; 15; 33; 12; 13; 18; 20; 20; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-1033_156a7c42-ecfe-4b87-b05e-018f10efb3d8 43742-1033 HUMAN OTC DRUG Kidney/Bladder Support Equisetum Hyemale, Solidago Virgaurea, Cantharis, Kidney (Suis), Berberis Vulgaris, Calcarea Carbonica, Terebinthina, Apis Mellifica, Pulsatilla (Vulgaris), Sepia, Staphysagria LIQUID ORAL 20170620 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EQUISETUM HYEMALE; SOLIDAGO VIRGAUREA FLOWERING TOP; LYTTA VESICATORIA; PORK KIDNEY; BERBERIS VULGARIS ROOT BARK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TURPENTINE OIL; APIS MELLIFERA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED 3; 3; 6; 8; 12; 12; 12; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1034_6f9ec160-6ddb-43c2-b005-22187bf4aa8d 43742-1034 HUMAN OTC DRUG Pericardium/Triple Warmer Meridian Formula Norepinephrine, Octopamine (Hydrochloride), Insulinum (Suis), Hydrocortisone (Cortisol), Ascorbic Acid, Glandula Suprarenalis Suis, Heart (Suis), Hypophysis Suis, Sarcolacticum Acidum, Thyroidinum (Suis), Adrenocorticotrophin, Gaertner Bacillus (Bach), Ubidecarenonum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Calcarea Carbonica, Glonoinum, Iodium, Kali Iodatum, Lachesis Mutus, Lithium Carbonicum, Lobelia Inflata, Mercurius Solubilis, Naja Tripudians, Phosphoricum Acidum, Phosphorus, Sepia, LIQUID ORAL 20180102 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. NOREPINEPHRINE; OCTOPAMINE; INSULIN PORK; HYDROCORTISONE; ASCORBIC ACID; SUS SCROFA ADRENAL GLAND; PORK HEART; SUS SCROFA PITUITARY GLAND; LACTIC ACID, L-; SUS SCROFA THYROID; CORTICOTROPIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; UBIDECARENONE; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; NITROGLYCERIN; IODINE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LITHIUM CARBONATE; LOBELIA INFLATA; MERCURIUS SOLUBILIS; NAJA NAJA VENOM; PHOSPHORIC ACID; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SPONGIA OFFICINALIS SKELETON, ROASTED; PROTEUS MORGANII 6; 6; 15; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20191231 43742-1035_b9ad7c8b-3f8a-42e0-b4d4-684b84d8ebeb 43742-1035 HUMAN OTC DRUG Bio Lymph Phase Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla (Smilax Regelii), Ascorbicum Acidum, Quercetin, Myosotis Arvensis, Calcarea Phosphorica, Ferrum Iodatum, Thyroidinum (Suis), Gaertner Bacillus LIQUID ORAL 20170720 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; ARANEUS DIADEMATUS; SMILAX REGELII ROOT; ASCORBIC ACID; QUERCETIN; MYOSOTIS ARVENSIS; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA THYROID; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 3; 3; 3; 4; 4; 4; 4; 4; 4; 5; 5; 5; 6; 6; 6; 6; 9; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-1036_eb640873-9f9b-440d-a66b-a859da18deb7 43742-1036 HUMAN OTC DRUG Elevate Lycopodium Clavatum, Natrum Muriaticum, Sepia, Causticum, Phosphorus, Sulphur, 5-Hydroxytryptophan, Alumina, Silicea, Acetylcholine Chloride, Dopamine Hydrochloride, Norepinephrine, Phenylethylamine (Hydrochloride), Serotonin (Hydrochloride), Adenosinum Cyclophosphoricum, Cerebrum (Suis), Diencephalon (Suis), Funiculus Umbilicalis Suis, Pantothenic Acid, Pineal Gland (Suis), Sarcolacticum Acidum, Faecalis (Alkaligenes), Gaertner Bacillus (Bach), Proteus (Vulgaris) LIQUID ORAL 20170720 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SEPIA OFFICINALIS JUICE; CAUSTICUM; PHOSPHORUS; SULFUR; OXITRIPTAN; ALUMINUM OXIDE; SILICON DIOXIDE; ACETYLCHOLINE CHLORIDE; DOPAMINE HYDROCHLORIDE; NOREPINEPHRINE; PHENETHYLAMINE HYDROCHLORIDE; SEROTONIN HYDROCHLORIDE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA UMBILICAL CORD; PANTOTHENIC ACID; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; ALCALIGENES FAECALIS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS VULGARIS 3; 3; 3; 4; 4; 4; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-1039_3e57a475-ccbe-45bd-8e6f-17609183a225 43742-1039 HUMAN OTC DRUG Healing Support Betula (Pendula) Cortex, Caltha Palustris, Galium Aparine, Thuja Occidentalis, Urtica Urens, Clematis Erecta, Hedera Helix, Juniperus Communis, Quillaja Saponaria, Sempervivum Tectorum, Echinacea (Angustifolia), Nitricum Acidum, Argentum Metallicum, Calcarea Fluorica, Sedum Acre, Phosphorus, Apis Mellifica, Pyrogenium, Ononis Spinosa LIQUID ORAL 20170721 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETULA PENDULA BARK; CALTHA PALUSTRIS; GALIUM APARINE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; CLEMATIS RECTA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; JUNIPER BERRY; QUILLAJA SAPONARIA BARK; SEMPERVIVUM TECTORUM LEAF; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; SILVER; CALCIUM FLUORIDE; SEDUM ACRE; PHOSPHORUS; APIS MELLIFERA; RANCID BEEF; ONONIS SPINOSA WHOLE 1; 3; 3; 3; 3; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 9; 12; 12; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-1046_3db49f1e-4311-4efa-98a2-9d62f2f8fad5 43742-1046 HUMAN OTC DRUG Vertigone Ambra Grisea, Natrum Salicylicum, Bryonia (Alba), Cyclamen Europaeum, Petroleum, Tabacum, Cerebellum, Argentum Nitricum, Asarum Canadense, Calcarea Sulphurica, Carboneum Sulphuratum, Chininum Sulphuricum, Cocculus Indica, Conium Maculatum, Digitalis Purpurea, Gelsemium Sempervirens, Phosphorus, Piper Methysticum, Silicea, Theridion LIQUID ORAL 20170728 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMBERGRIS; SODIUM SALICYLATE; BRYONIA ALBA ROOT; CYCLAMEN PURPURASCENS TUBER; KEROSENE; TOBACCO LEAF; SUS SCROFA CEREBELLUM; SILVER NITRATE; ASARUM CANADENSE ROOT; CALCIUM SULFATE ANHYDROUS; CARBON DISULFIDE; QUININE SULFATE; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; MACROPIPER METHYSTICUM ROOT; SILICON DIOXIDE; THERIDION CURASSAVICUM 3; 3; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1047_9b92e62f-5d31-46bc-9318-04a9b8609f44 43742-1047 HUMAN OTC DRUG Herpes Simplex Plus Allium Sativum, Calendula Officinalis, Sambucus Nigra, Clematis Erecta, Dulcamara, Petroleum, Sarsaparilla (Smilax Regelii), Graphites, Arsenicum Album, Croton Tiglium, Mercurius Sulphuratus Ruber, Natrum Muriaticum, Nitricum Acidum, Rhus Tox, Sepia, Thuja Occidentalis LIQUID ORAL 20170731 UNAPPROVED HOMEOPATHIC Deseret Biologicals,Inc. GARLIC; CALENDULA OFFICINALIS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; CLEMATIS RECTA FLOWERING TOP; SOLANUM DULCAMARA TOP; KEROSENE; SMILAX ORNATA ROOT; GRAPHITE; ARSENIC TRIOXIDE; CROTON TIGLIUM SEED; MERCURIC SULFIDE; SODIUM CHLORIDE; NITRIC ACID; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 2; 2; 3; 6; 6; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1048_8f71cdf5-1444-4882-bdaf-0cbcb1678b1b 43742-1048 HUMAN OTC DRUG Herpes Zoster Plus Cistus Canadensis, Clematis Erecta, Croton Tiglium, Dolichos Pruriens, Iris Versicolor, Kali Bichromicum, Prunus Spinosa, Ranunculus Bulbosus, Zincum Phosphoratum, Arsenicum Album, Comocladia Dentata, Graphites, Kalmia Latifolia, Lachesis Mutus, Mezereum, Rhus Tox, Thallium Metallicum LIQUID ORAL 20170906 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; CROTON TIGLIUM SEED; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; POTASSIUM DICHROMATE; PRUNUS SPINOSA FLOWER BUD; RANUNCULUS BULBOSUS; ZINC PHOSPHIDE; ARSENIC TRIOXIDE; COMOCLADIA DENTATA BARK/LEAF; GRAPHITE; KALMIA LATIFOLIA LEAF; LACHESIS MUTA VENOM; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; THALLIUM 6; 6; 6; 6; 6; 6; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1049_efbc8b20-b034-4448-a09a-a2e859e13fee 43742-1049 HUMAN OTC DRUG PTSD/Stress Remedy Kali Phosphoricum, Ambra Grisea, Cacao, Lithium Carbonicum, Phosphoricum Acidum, Arnica Montana, Aconitum Napellus, Calcarea Carbonica, Cerebrum Suis, Glandula Suprarenalis Suis, Argemone Mexicana, Arsenicum Album, Cicuta Virosa, Hyoscyamus Niger, Ignatia Tigrinum, Natrum Muriaticum, Tarentula Hispanica, Stramonium, Buthus Australis LIQUID ORAL 20170801 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. DIBASIC POTASSIUM PHOSPHATE; AMBERGRIS; COCOA; LITHIUM CARBONATE; PHOSPHORIC ACID; ARNICA MONTANA; ACONITUM NAPELLUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SUS SCROFA CEREBRUM; SUS SCROFA ADRENAL GLAND; ARGEMONE MEXICANA; ARSENIC TRIOXIDE; CICUTA VIROSA ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; SODIUM CHLORIDE; LYCOSA TARANTULA; DATURA STRAMONIUM; ANDROCTONUS AUSTRALIS VENOM 3; 6; 6; 6; 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-1060_e24268ce-6f5c-4fd2-bba8-b95f7fb3f0cb 43742-1060 HUMAN OTC DRUG Clostridium Difficile Homochord Clostridium Difficile LIQUID ORAL 20170912 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CLOSTRIDIUM DIFFICILE 15 [hp_X]/mL N 20181231 43742-1082_177d5735-f681-41e9-8140-9d68ef3af174 43742-1082 HUMAN OTC DRUG Celeragesic Echinacea (Angustifolia), Calendula Officinalis, Hamamelis Virginiana, Echinacea Purpurea, Bellis Perennis, Chamomilla, Hypericum Perforatum, Millefolium, Ledum Palustre, Arnica Montana, Bryonia (Alba), Rhus Tox, Hepar Sulphuris Calcareum, Nadidum, Pantothenic Acid, Sarcolacticum Acidum, Symphytum Officinale, Aconitum Napellus, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis LIQUID ORAL 20170922 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ECHINACEA PURPUREA; BELLIS PERENNIS; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; ARNICA MONTANA; BRYONIA ALBA ROOT; TOXICODENDRON PUBESCENS LEAF; CALCIUM SULFIDE; NADIDE; PANTOTHENIC ACID; LACTIC ACID, L-; COMFREY ROOT; ACONITUM NAPELLUS; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND 1; 1; 1; 2; 2; 3; 3; 3; 4; 4; 6; 6; 8; 8; 8; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1083_4707b48a-7929-4302-b579-0d4acd7dcaac 43742-1083 HUMAN OTC DRUG Celeragesic Echinacea (Angustifolia), Calendula Officinalis, Hamamelis Virginiana, Echinacea Purpurea, Bellis Perennis, Chamomilla, Hypericum Perforatum, Millefolium, Ledum Palustre, Arnica Montana, Bryonia (Alba), Rhus Tox, Hepar Sulphuris Calcareum, Nadidum, Pantothenic Acid, Sarcolacticum Acidum, Symphytum Officinale, Aconitum Napellus, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis GEL TOPICAL 20170925 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ECHINACEA PURPUREA; BELLIS PERENNIS; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; ARNICA MONTANA; BRYONIA ALBA ROOT; TOXICODENDRON PUBESCENS LEAF; CALCIUM SULFIDE; NADIDE; PANTOTHENIC ACID; LACTIC ACID, L-; COMFREY ROOT; ACONITUM NAPELLUS; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND 1; 1; 1; 3; 3; 3; 3; 3; 4; 4; 6; 6; 8; 8; 8; 8; 8; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43742-1084_25dfd307-3657-49e3-947b-c2dd9cd1edc6 43742-1084 HUMAN OTC DRUG Vertigone Ambra Grisea, Natrum Salicylicum, Bryonia (Alba), Cyclamen Europaeum, Petroleum, Tabacum, Cerebellum, Argentum Nitricum, Asarum Canadense, Calcarea Sulphurica, Carboneum Sulphuratum, Chininum Sulphuricum, Cocculus Indicus, Conium Maculatum, Digitalis Purpurea, Gelsemium Sempervirens, Phosphorus, Piper Methysticum, Silicea, Theridion LIQUID ORAL 20170925 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMBERGRIS; SODIUM SALICYLATE; BRYONIA ALBA ROOT; KEROSENE; TOBACCO LEAF; SUS SCROFA CEREBELLUM; CYCLAMEN PURPURASCENS TUBER; SILVER NITRATE; ASARUM CANADENSE ROOT; CALCIUM SULFATE ANHYDROUS; CARBON DISULFIDE; QUININE SULFATE; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; MACROPIPER METHYSTICUM ROOT; SILICON DIOXIDE; THERIDION CURASSAVICUM 3; 3; 6; 6; 6; 6; 9; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1087_8b1ce9cd-f8c0-4697-a668-4fc3fd675eeb 43742-1087 HUMAN OTC DRUG Addiclenz Beta Vulgaris, Boldo, Chelidonium Majus, Petroselinum Sativum, Taraxacum Officinale, Arsenicum Album, Cobaltum Metallicum, Cuprum Metallicum, Iodium, Lycopodium Clavatum, Phosphoricum Acidum, Selenium Metallicum, Zincum Metallicum, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methyl Paraben, Propyl Paraben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum LIQUID ORAL 20171018 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; PETROSELINUM CRISPUM; TARAXACUM OFFICINALE; ARSENIC TRIOXIDE; COBALT; COPPER; IODINE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SELENIUM; ZINC; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1088_60f5edef-70c9-4192-8f55-e67ab6cfb916 43742-1088 HUMAN OTC DRUG Immune Support Echinacea (Angustifolia), Aconitum Napellus, Arnica Montana, Baptisia Tinctoria, Rhus Tox, Sanguinaria Canadensis, Aristolochia Clematitis, Bryonia (Alba), Eupatorium Perfoliatum, Euphorbium Officinarum, Gelsemium Sempervirens, Mercurius Corrosivus, Phytolacca Decandra, Argentum Nitricum, Arsenicum Album, Phosphorus, Pulsatilla (Vulgaris), Sulphur, Thuja Occidentalis, Hepar Sulphuris Calcareum, Lachesis Mutus, Zincum Metallicum, Astragalus Menziesii, Influenzinum (2017-2018), Spleen (Suis) LIQUID ORAL 20171018 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; ACONITUM NAPELLUS; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; ARISTOLOCHIA CLEMATITIS ROOT; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; MERCURIC CHLORIDE; PHYTOLACCA AMERICANA ROOT; SILVER NITRATE; ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; CALCIUM SULFIDE; LACHESIS MUTA VENOM; ZINC; ASTRAGALUS NUTTALLII LEAF; INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); SUS SCROFA SPLEEN; SUS SCROFA THYMUS; VISCUM ALBUM FRUITING TOP; CORTISONE ACETATE; RANCID BEEF 1; 3; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12; 13; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1089_a1ee91c3-0ca9-4129-9e5d-aa26669f24bf 43742-1089 HUMAN OTC DRUG Pertussis Aconitum Napellus, Bryonia (Alba), Hyoscyamus Niger, Ipecacuanha, Sticta Pulmonaria, Tabacum, Phosphorus, Antimonium Tartaricum, Kreosotum, Silicea, Pertussinum, Tetanus Toxin LIQUID ORAL 20171031 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HYOSCYAMUS NIGER; IPECAC; LOBARIA PULMONARIA; TOBACCO LEAF; PHOSPHORUS; ANTIMONY POTASSIUM TARTRATE; WOOD CREOSOTE; SILICON DIOXIDE; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; CLOSTRIDIUM TETANI 4; 4; 4; 4; 4; 4; 5; 6; 6; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1090_e010b7ca-3134-4b07-a112-76185702521a 43742-1090 HUMAN OTC DRUG Trauma Relief Chamomilla, Echinacea (Angustifolia), Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Bryonia (Alba), Calendula Officinalis, Arnica Montana, Bellis Perennis, Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos, Symphytum Officinale, Rhus Tox, Hepar Sulphuris Calcareum, Carbo Vegetabilis GEL TOPICAL 20171102 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; BELLIS PERENNIS; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; COMFREY ROOT; TOXICODENDRON PUBESCENS LEAF; CALCIUM SULFIDE; ACTIVATED CHARCOAL 3; 3; 3; 3; 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43742-1091_298ec9ab-93ef-4c48-9698-d8f1b49bd59e 43742-1091 HUMAN OTC DRUG Matrix Support Ceanothus Americanus, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Hydrastis Canadensis, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (Vulgaris), Bile Duct (Suis), Colon (Suis), Duodenum (Suis), Esophagus (Suis), Eye (Suis), Gallbladder (Suis), Ileum (Suis), Intestine (Suis), Ipecacuanha, Jejunum (Suis), Kali Bichromicum, Lung (Suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (Suis), Pancreas Suis, Phosphorus, Rectal Mucosa (Suis), Stomach (Suis), Sulphur, Mannan, LIQUID ORAL 20171102 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CEANOTHUS AMERICANUS LEAF; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; MARSDENIA CONDURANGO BARK; GOLDENSEAL; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PULSATILLA VULGARIS; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-1092_7077bb18-158e-4967-92d7-35d1df16f03f 43742-1092 HUMAN OTC DRUG Mucous Membrane Core Formula Ceanothus Americanus, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Hydrastis Canadensis, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (Vulgaris), Bile Duct (Suis), Colon (Suis), Duodenum (Suis), Esophagus (Suis), Eye (Suis), Gallbladder (Suis), Ileum (Suis), Intestine (Suis), Ipecacuanha, Jejunum (Suis), Kali Bichromicum, Lung (Suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (Suis), Pancreas Suis, Phosphorus, Rectal Mucosa (Suis), Stomach (Suis), Sulphur, Mannan, LIQUID ORAL 20171102 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CEANOTHUS AMERICANUS LEAF; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; MARSDENIA CONDURANGO BARK; GOLDENSEAL; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PULSATILLA VULGARIS; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-1094_78938379-1cc5-426b-ab91-9d5562fe9fea 43742-1094 HUMAN OTC DRUG Nausia Zingiber Officinale, Cyclamen Europaeum, Ipecacuanha, Iris Versicolor, Lac Defloratum, Lacticum Acidum, Tabacum, Petroleum, Euphorbia Corollata, Arsenicum Album, Bryonia (Alba), Cadmium Sulphuratum, Cocculus Indicus, Colchicum Autumnale, Conium Maculatum, Ferrum Metallicum, Nux Vomica, Pulsatilla (Pratensis), Sepia, Theridion LIQUID ORAL 20171117 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GINGER; CYCLAMEN PURPURASCENS TUBER; IPECAC; IRIS VERSICOLOR ROOT; SKIM MILK; LACTIC ACID, DL-; TOBACCO LEAF; KEROSENE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CADMIUM SULFIDE; ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; IRON; STRYCHNOS NUX-VOMICA SEED; ANEMONE PRATENSIS; SEPIA OFFICINALIS JUICE; THERIDION CURASSAVICUM; EUPHORBIA COROLLATA ROOT 3; 6; 6; 6; 6; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 24 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1095_ec0c518c-878e-460c-a983-a0f1bd97f060 43742-1095 HUMAN OTC DRUG Trauma Remedy Chamomilla, Echinacea (Angustifolia), Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Bryonia (Alba), Calendula Officinalis, Arnica Montana, Bellis Perennis, Rhus Tox, Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Hepar Sulphuris Calcareum, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos, Carbo Vegetabilis LIQUID ORAL 20171106 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; BELLIS PERENNIS; TOXICODENDRON PUBESCENS LEAF; CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; CALCIUM SULFIDE; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER; ACTIVATED CHARCOAL 3; 3; 3; 3; 3; 4; 4; 4; 6; 6; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1096_e8fc8318-06cb-45e1-a365-5c952ca9e97c 43742-1096 HUMAN OTC DRUG Influenza Plus Eucalyptus Globulus, Ipecacuanha, Aconitum Napellus, Influenzinum, Respiratory Syncytial Virus Nosode (RSV), Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Kreosotum, Veratrum Viride LIQUID ORAL 20171106 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EUCALYPTUS GLOBULUS LEAF; IPECAC; INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN); BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; WOOD CREOSOTE; VERATRUM VIRIDE ROOT 2; 3; 8; 8; 8; 8; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-1097_96bdee95-2db4-4635-a358-c9b159fa19fe 43742-1097 HUMAN OTC DRUG Lymph/Spleen Combo Juniperus Communis, Phytolacca Decandra, Quercus Glandium Spiritus, Myosotis Arvensis, Natrum Sulphuricum, Ceanothus Americanus, Helianthus Annuus, Natrum Muriaticum, Lymph (Suis), Spleen (Suis), Thymus (Suis), Chininum Arsenicosum, Castanea Vesca, Adenosinum Triphosphoricum Dinatrum, Coenzyme Q10, Ferrum Metallicum, Succinum, Apis Mellifica LIQUID ORAL 20171106 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. JUNIPERUS COMMUNIS WHOLE; PHYTOLACCA AMERICANA ROOT; QUERCUS ROBUR NUT; MYOSOTIS ARVENSIS; SODIUM SULFATE; CEANOTHUS AMERICANUS LEAF; HELIANTHUS ANNUUS FLOWERING TOP; SODIUM CHLORIDE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; QUININE ARSENATE; CASTANEA SATIVA LEAF; ADENOSINE TRIPHOSPHATE DISODIUM; UBIDECARENONE; IRON; AMBER; APIS MELLIFERA 3; 3; 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 9; 12; 12; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-1113_64789f00-555d-49c3-8f05-377707c1bdc6 43742-1113 HUMAN OTC DRUG Sore Throat Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla (Smilax Regelii), Calcarea Phosphorica, Ferrum Iodatum, Lymph Nose (Suis), Thyroidinum (Suis) LIQUID ORAL 20171129 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; ARANEUS DIADEMATUS; SMILAX ORNATA ROOT; MYOSOTIS ARVENSIS; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA LYMPH; SUS SCROFA THYROID 3; 3; 3; 4; 4; 4; 4; 4; 4; 5; 5; 5; 6; 6; 9; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1114_42fdf4f7-e799-487a-b5d0-ff1726526b9e 43742-1114 HUMAN OTC DRUG Enviroclenz Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Stillingia Sylvatica, Taraxacum Officinale, Trifolium Pratense, Germanium Sesquioxide, Benzinum, Chlorinum, Acetone, Ammonium Muriaticum, Propylene Glycol, Sodium Benzene Sulfonate, Sodium Lauryl Sulfate, Sodium Tripolyphosphate, Terebinthina, Methanol, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20171130 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; STILLINGIA SYLVATICA ROOT; TARAXACUM OFFICINALE FLOWERING TOP; TRIFOLIUM PRATENSE LEAF; GERMANIUM SESQUIOXIDE; BENZENE; CHLORINE; ACETONE; AMMONIUM CHLORIDE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; SODIUM LAURYL SULFATE; SODIUM TRIPOLYPHOSPHATE; TURPENTINE OIL; METHYL ALCOHOL; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1115_09ee02f7-6817-4909-9934-e7af92c2964d 43742-1115 HUMAN OTC DRUG Focus Adenosinum Triphosphoricum Dinatrum, Alpha-Ketoglutaricum Acidum, Formicum Acidum, Malicum Acidum, Sarcolacticum Acid, Dulcamara, Hyoscyamus Niger, Phosphorus, Sabina, Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, GABA(Gamma-Aminobutyric Acid), Norepinephrine, Octopamine (Hydrochloride), Phenylethylamine (Hydrochloride), Serotonin (Hydrochloride), Taurine, Tyramine, Adenosinum Cyclophosphoricum, Brain Stem (Suis), Cerebrum Suis, Diencephalon (Suis), Pineal Gland (Suis) LIQUID ORAL 20171212 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ADENOSINE TRIPHOSPHATE DISODIUM; OXOGLURIC ACID; FORMIC ACID; MALIC ACID; LACTIC ACID, L-; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; PHOSPHORUS; JUNIPERUS SABINA LEAFY TWIG; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; DOPAMINE HYDROCHLORIDE; .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; OCTOPAMINE HYDROCHLORIDE; PHENETHYLAMINE HYDROCHLORIDE; SEROTONIN HYDROCHLORIDE; TAURINE; TYRAMINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA BRAINSTEM; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS; SILICON DIOXIDE; ARSENIC TRIOXIDE; SHIGELLA DYSENTERIAE; STRYCHNOS NUX-VOMICA SEED; LYCOSA TARANTULA; VALERIAN; VERATRUM ALBUM ROOT 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-1116_0954b536-ff79-4c1b-bd20-f8c6ee6272fe 43742-1116 HUMAN OTC DRUG Viracomp Allium Sativum, Echinacea (Angustifolia), Ginkgo Biloba, Viscum Album, Hamamelis Virginiana, Aconitum Napellus, Allium Cepa, Arsenicum Album, Baptisia Tinctoria, Chelidonium Majus, Gelsemium Sempervirens, Mercurius Vivus, Natrum Muriaticum, Nux Vomica, Selenium Metallicum, Influenzinum (2017-2018) Morbillinum LIQUID ORAL 20171214 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. GARLIC; ECHINACEA ANGUSTIFOLIA; GINKGO; VISCUM ALBUM FRUITING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACONITUM NAPELLUS; ONION; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CHELIDONIUM MAJUS; GELSEMIUM SEMPERVIRENS ROOT; MERCURY; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SELENIUM; INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); MEASLES VIRUS 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1117_62da1149-1861-419a-90fc-b1e1afd8c38e 43742-1117 HUMAN OTC DRUG Virus Plus Influenzinum (2017-2018), Adenoviren Nosode, Herpes Simplex 1 Nosode, Herpes Simplex 2 Nosode, Cytomegalovirus Nosode, Epstein-Barr Virus Nosode, Hepatitis B Nosode, Norovirus Nosode LIQUID ORAL 20171214 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; HUMAN ADENOVIRUS B SEROTYPE 7 STRAIN 55142 ANTIGEN; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4; HEPATITIS B VIRUS; NORWALK VIRUS 12; 12; 12; 15; 15; 15; 15; 18; 18; 33; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43742-1118_7f0885c6-4519-49dd-a1fc-d75c5c053d29 43742-1118 HUMAN OTC DRUG GI Distress Echinacea (Angustifolia), Colchicum Autumnale, Natrum Phosphoricum, Arsenicum Album, Colocynthis, Croton Tiglium, Gambogia, Aceticum Acidum, Antimonium Crudum, Bismuthum Subnitricum, Cinchona Officinalis, Ferrum Metallicum, Iris Versicolor, Lac Defloratum, Mercurius Vivus, Nux Vomica, Ricinus Communis, Veratrum Album, Colibacillinum Cum Natrum Muriaticum, Proteus (Mirabilis) LIQUID ORAL 20171228 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. ECHINACEA ANGUSTIFOLIA; COLCHICUM AUTUMNALE BULB; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; ARSENIC TRIOXIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; GAMBOGE; ACETIC ACID; ANTIMONY TRISULFIDE; BISMUTH SUBNITRATE; CINCHONA OFFICINALIS BARK; IRON; IRIS VERSICOLOR ROOT; SKIM MILK; MERCURY; STRYCHNOS NUX-VOMICA SEED; RICINUS COMMUNIS SEED; VERATRUM ALBUM ROOT; ESCHERICHIA COLI; PROTEUS MIRABILIS 3; 6; 6; 6; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 16; 16 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1119_8456f757-e484-48d5-bf0d-4cb25255d284 43742-1119 HUMAN OTC DRUG ENT Support Pulsatilla (Vulgaris), Euphorbium Officinarum, Luffa Operculata, Mercurius Iodatus Ruber, Argentum Nitricum, Hepar Sulphuris Calcareum, Influenzinum (2017-2018), Sinusitisinum, Aspergillus Niger, Candida Albicans, Gallicum Acidum, Mucor Racemosus, Mutabile Bacillus (Bach) LIQUID ORAL 20171215 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. PULSATILLA VULGARIS; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SILVER NITRATE; CALCIUM SULFIDE; INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); SINUSITISINUM; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; GALLIC ACID MONOHYDRATE; MUCOR RACEMOSUS; ESCHERICHIA COLI 2; 6; 6; 8; 10; 10; 12; 12; 12; 17; 10; 10; 10; 10; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43742-1120_8567c70a-d312-41a0-af88-7655fcb413ea 43742-1120 HUMAN OTC DRUG Addiclenz Beta Vulgaris, Boldo, Chelidonium Majus, Petroselinum Sativum, Taraxacum Officinale, Arsenicum Album, Bisphenol A, Cobaltum Metallicum, Cuprum Metallicum, Glyphosate, Iodium, Lycopodium Clavatum, Phosphoricum Acidum, Selenium Metallicum, Zincum Metallicum, Bacillus Thuringiensis (BT Toxin), Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methyl Paraben, Propyl Paraben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum LIQUID ORAL 20171219 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; PETROSELINUM CRISPUM; TARAXACUM OFFICINALE; ARSENIC TRIOXIDE; BISPHENOL A; COBALT; COPPER; GLYPHOSATE; IODINE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SELENIUM; ZINC; BACILLUS THURINGIENSIS; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1121_e81f844a-0a67-4546-a15f-ad26a0b9a08f 43742-1121 HUMAN OTC DRUG Esteem Ambra Grisea, Lilium Tigrinum, Lycopodium Clavatum, Natrum Carbonicum, Viscum Album, Thuja Occidentalis, Hypothalamus (Suis), Cubeba Officinalis, Agnus Castus, Anacardium Orientale, Baryta Iodata, Lac Caninum, Lac Felinum, Naja Tripudians, Rhus Glabra, Rosa Damascena, Sabadilla, Aurum Metallicum, Magnesium Iodide, Carcinosinum LIQUID ORAL 20171219 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. AMBERGRIS; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; VISCUM ALBUM FRUITING TOP; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA HYPOTHALAMUS; PIPER CUBEBA FRUIT; CHASTE TREE; SEMECARPUS ANACARDIUM JUICE; BARIUM IODIDE; CANIS LUPUS FAMILIARIS MILK; FELIS CATUS MILK; NAJA NAJA VENOM; RHUS GLABRA TOP; ROSA X DAMASCENA FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; GOLD; MAGNESIUM IODIDE; HUMAN BREAST TUMOR CELL 6; 6; 6; 6; 6; 6; 8; 9; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 16; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43742-1132_5b7a91c8-5f84-4f7b-98da-25c39cf0805f 43742-1132 HUMAN OTC DRUG AnXious Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Passiflora Incarnata, Angelica Sinensis, Radix, Argentum Nitricum, Cacao, Lithium Carbonicum, Prunus Cerasifera, Flos, Valeriana Officinalis, Glandula Suprarenalis Suis, Aconitum Napellus, Anacardium Orientale, Arsenicum Album, Calcarea Carbonica, Cocculus Indicus, Ignatia Amara, Piper Methysticum, Gelsemium Sempervirens LIQUID ORAL 20171229 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; ANGELICA SINENSIS ROOT; SILVER NITRATE; COCOA; LITHIUM CARBONATE; PRUNUS CERASIFERA FLOWER; VALERIAN; SUS SCROFA ADRENAL GLAND; ACONITUM NAPELLUS; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANAMIRTA COCCULUS SEED; STRYCHNOS IGNATII SEED; MACROPIPER METHYSTICUM ROOT; GELSEMIUM SEMPERVIRENS ROOT 3; 3; 3; 3; 3; 6; 6; 6; 6; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 43742-1133_8ecf52db-e295-4e41-8ef1-bfaac25a61eb 43742-1133 HUMAN OTC DRUG Toxoplasma Gondii Homochord Toxoplasma Gondii LIQUID ORAL 20171229 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. TOXOPLASMA GONDII 15 [hp_X]/mL N 20191231 43742-1137_aa774d70-7d7f-4af3-9575-5055d90497f5 43742-1137 HUMAN OTC DRUG Influenza Plus Eucalyptus Globulus, Ipecacuanha, Aconitum Napellus, Influenzinum, Respiratory Syncytial Virus Nosode (RSV), Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Kreosotum, Veratrum Viride LIQUID ORAL 20171229 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. EUCALYPTUS GLOBULUS LEAF; IPECAC; ACONITUM NAPELLUS; INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN INTRAVENOUS (HUMAN); BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; WOOD CREOSOTE; VERATRUM VIRIDE ROOT 2; 3; 3; 8; 8; 8; 9; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20191231 43742-1138_779120a6-a9ab-4a03-a1d4-014430fbe60f 43742-1138 HUMAN OTC DRUG Chemtox Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Glandula Suprarenalis Suis, Hepar Suis, Lymph Node (Suis), Thyroidinum (Suis), Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum, Selenium Metallicum, Salicylicum Acidum, Adrenocorticotrophin, Cortisone Aceticum, Eugenol, Stearyl Alcohol, Xylitol, Folliculinum, Benzoicum Acidum, Chlorinum, Potassium Sorbate, Sorbitol, Resorcinum LIQUID ORAL 20180102 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA LYMPH; SUS SCROFA THYROID; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; SELENIUM; SALICYLIC ACID; CORTICOTROPIN; CORTISONE ACETATE; EUGENOL; STEARYL ALCOHOL; XYLITOL; ESTRONE; BENZOIC ACID; CHLORINE; POTASSIUM SORBATE; SORBITOL; RESORCINOL; BENZYL ALCOHOL; LACTIC ACID; ISOPROPYL PALMITATE; BORIC ACID; ACETIC ACID; PHENYLBUTAZONE; PETROLATUM; LEAD 3; 3; 3; 3; 3; 3; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 43742-1149_7b098ec5-c6f8-4934-8800-2d26427a69b2 43742-1149 HUMAN OTC DRUG Amoeba Baptisia Tinctoria, Cajuputum, Capsicum Annuum, Fragaria Vesca, Frasera Caroliniensis, Hamamelis Virginiana, Quassia (Amara), Senna (Cassia Angustifolia), Hydrastis Canadensis, Ipecacuanha, Hepar Suis, Pancreas Suis, Spleen (Suis), Cinchona Officinalis, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Selenium Metallicum, Blastocystis Hominis, Cryptosporidium Parvum, Entamoeba Histolytica, Giardia Lamblia, Brugia Malayi LIQUID ORAL 20180111 UNAPPROVED HOMEOPATHIC Deseret Biologicals, Inc. BAPTISIA TINCTORIA ROOT; CAJUPUT OIL; CAPSICUM; ALPINE STRAWBERRY; FRASERA CAROLINIENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; QUASSIA AMARA WOOD; SENNA LEAF; GOLDENSEAL; IPECAC; PORK LIVER; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; CINCHONA OFFICINALIS BARK; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; SELENIUM; BLASTOCYSTIS HOMINIS; CRYPTOSPORIDIUM PARVUM; ENTAMOEBA HISTOLYTICA; GIARDIA LAMBLIA; BRUGIA MALAYI 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 39 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20191231 43749-110_9f496354-1f41-4572-9f63-830be483a33f 43749-110 HUMAN OTC DRUG Avedana Medicated Chest Rub Camphor Eucalyptus Menthol OINTMENT TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part348 Unipack, Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g N 20181231 43749-112_34b44cbd-7562-481b-e054-00144ff8d46c 43749-112 HUMAN OTC DRUG Natures Choice Baby Talc POWDER TOPICAL 20160607 OTC MONOGRAPH NOT FINAL part347 Unipack, Inc. TALC 99 g/100g N 20181231 43749-230_921f72a8-c8b7-4ab3-b9fa-cb28cfa23afa 43749-230 HUMAN OTC DRUG Natures Choice Vitamins A and D A and D Ointment OINTMENT TOPICAL 20140918 OTC MONOGRAPH FINAL part347 Unipack, Inc. PETROLATUM 99.397 g/100g N 20191231 43749-230_da1c3876-8a76-4864-8c92-8ed99edbabcb 43749-230 HUMAN OTC DRUG Natures Choice Vitamins A and D A and D Ointment OINTMENT TOPICAL 20140918 OTC MONOGRAPH FINAL part347 Unipack, Inc. PETROLATUM 99.397 g/100g N 20191231 43749-231_57dc7ead-672a-47cc-a260-ad4f74213986 43749-231 HUMAN OTC DRUG Moisture Barrier Moisture Barrier Ointment OINTMENT TOPICAL 20180203 OTC MONOGRAPH FINAL part347 Unipack, Inc. PETROLATUM 98.3 g/100g N 20191231 43749-250_10abab0a-2e42-4146-8196-af764a684498 43749-250 HUMAN OTC DRUG Maximum Strength Hydrocortisone Hydrocortisone Ointment OINTMENT TOPICAL 20180203 OTC MONOGRAPH NOT FINAL part348 Unipack, Inc. HYDROCORTISONE 1.02 g/100g N 20191231 43749-310_664e5194-4311-4d46-a3a0-09bf7470e829 43749-310 HUMAN OTC DRUG Avedana Pain Relieving Roll On Menthol GEL TOPICAL 20140929 OTC MONOGRAPH NOT FINAL part348 Unipack, Inc. MENTHOL; CAMPHOR (SYNTHETIC) 3.5; .4 g/100g; g/100g N 20181231 43749-320_7b240653-d20c-4ea0-bbb0-6dbb4d41c574 43749-320 HUMAN OTC DRUG Natures Choice Cool Hot Ice Menthol GEL TOPICAL 20140918 OTC MONOGRAPH NOT FINAL part348 Unipack, Inc. MENTHOL 2 g/100g N 20181231 43749-321_c9a6a09a-24d8-4627-9635-cd97e2ef09cd 43749-321 HUMAN OTC DRUG Avedana Cool Hot Ice Menthol GEL TOPICAL 20171104 OTC MONOGRAPH NOT FINAL part348 Unipack, Inc. MENTHOL 2 g/100g N 20181231 43749-430_ffd6f5de-8ade-4f26-8df9-2fa7eaa9cbf2 43749-430 HUMAN OTC DRUG Avedana Hemorrhoidal Hemorrhoidal Rectal Suppositories SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH FINAL part346 Unipack, Inc. COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 88.5; .26 g/100g; g/100g N 20181231 43749-440_717beeab-32fa-4ee9-9119-693a6765a0a8 43749-440 HUMAN OTC DRUG Avedana Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 Unipack, Inc. GLYCERIN 83 g/100g N 20181231 43749-440_d82b897e-c28e-4d29-9e2f-dc5fad66c2e4 43749-440 HUMAN OTC DRUG Avedana Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20170917 OTC MONOGRAPH NOT FINAL part334 Unipack, Inc. GLYCERIN 83 g/100g N 20181231 43749-460_c3ddc96f-5c3b-461c-b375-72988c5bcc2d 43749-460 HUMAN OTC DRUG Gentle Laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20170917 OTC MONOGRAPH NOT FINAL part334 Unipack, Inc. BISACODYL 10 mg/2000mg N 20181231 43749-510_beabd663-04a3-4066-ada6-06104e15a815 43749-510 HUMAN OTC DRUG Avedana Pain-Relieving Menthol SPRAY TOPICAL 20140929 OTC MONOGRAPH NOT FINAL part348 Unipack, Inc. MENTHOL 9 g/100g N 20181231 43749-620_9a0b7cd8-0993-415e-9a14-49c95b12f1f8 43749-620 HUMAN OTC DRUG Avedana Hydrocortisone Cream with Aloe Hydrocortisone Cream OINTMENT TOPICAL 20160407 OTC MONOGRAPH NOT FINAL part348 Unipack HYDROCORTISONE 1.02 g/100g N 20191231 43749-720_34571232-7342-437a-83c5-ae562988cf51 43749-720 HUMAN OTC DRUG Petroleum Jelly White Petrolatum JELLY TOPICAL 20171210 OTC MONOGRAPH FINAL part347 Unipack, Inc. PETROLATUM 100 g/100g N 20181231 43772-0001_9e649bda-788b-40ee-a64f-a38a48d535aa 43772-0001 HUMAN OTC DRUG Stomach Tincture Gentiana Lutea, Sambucus Nigra, Senna, Stomach (bovine), Arsenicum Album, Atropinum Sulphuricum, Carbo Vegetabilis LIQUID ORAL 20120822 UNAPPROVED HOMEOPATHIC Synergy Formulas GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; SENNA LEAF; TRIPE; ARSENIC TRIOXIDE; ATROPINE SULFATE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 3; 3; 6; 12; 12; 12; 12; 12; 12 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL N 20181231 43772-0002_ea5c04d0-23a1-4dbc-bfc8-05b96ab76e34 43772-0002 HUMAN OTC DRUG Neurosode Glandula Suprarenalis Suis, Brain (suis), Kidney (suis), Ubiquinone, Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Phosphorus, Rhus Tox, Naja Tripudians, Latrodectus Mactans, Tarentula Cubensis, Gelsemium Sempervirens, Epstein Barr Nosodes, Herpes Zoster Nosodes, Morbillinum, Poliomyelitis Nosodes, Hepatitis B Nosodes, Coxsackie B1 Nosodes, Coxsackie B4 Nosodes, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methyl Paraben, Propyl Paraben, Sodium Benzoate, LIQUID ORAL 20120822 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc SUS SCROFA ADRENAL GLAND; PORK BRAIN; PORK KIDNEY; UBIDECARENONE; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; PROTORTONIA CACTI; CONIUM MACULATUM FLOWERING TOP; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; NAJA NAJA VENOM; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE; LATRODECTUS MACTANS; CITHARACANTHUS SPINICRUS; GELSEMIUM SEMPERVIRENS ROOT; SALICYLIC ACID; CORTICOTROPIN; CORTISONE ACETATE; EUGENOL; STEARYL ALCOHOL; XYLITOL; ESTRONE; BENZOIC ACID; CHLORINE; POTASSIUM SORBATE; SORBITOL; RESORCINOL; BENZYL ALCOHOL; LACTIC ACID, DL-; ISOPROPYL PALMITATE; BORIC ACID; ACETIC ACID; PHENYLBUTAZONE; PETROLATUM; LEAD; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 3; MEASLES VIRUS; POLIOVIRUS; HEPATITIS B VIRUS; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4 8; 8; 8; 8; 12; 12; 12; 12; 12; 15; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43772-0003_968f65a8-2db0-4a75-afe7-b8282541836b 43772-0003 HUMAN OTC DRUG Bacsode Hydrastis Canadensis, Myrrha, Tabebuia Impetiginosa, Belladonna, Thymus, Glandula Suprarenalis Bovinum, Spleen LIQUID ORAL 20130329 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. GOLDENSEAL; MYRRH; TABEBUIA IMPETIGINOSA BARK; ATROPA BELLADONNA WHOLE; BOS TAURUS THYMUS; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; HYPERICUM PERFORATUM; PHOSPHORUS; CROTALUS HORRIDUS HORRIDUS VENOM; LOMATIUM DISSECTUM ROOT; BOTULINUM TOXIN TYPE A; CHLAMYDIA TRACHOMATIS; CLOSTRIDIUM TETANI; ESCHERICHIA COLI; NEISSERIA MENINGITIDIS; PASTEURELLA MULTOCIDA; STREPTOCOCCUS PNEUMONIAE; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; STAPHYLOCOCCUS AUREUS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 3; 3; 3; 6; 8; 8; 8; 12; 12; 12; 12; 18; 18; 18; 18; 18; 18; 18; 18; 18; 18; 18; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0004_5b5ec7ae-8397-4f27-9b69-5451902f1116 43772-0004 HUMAN OTC DRUG Adrenal Tincture Chelidonium Majus, Echinacea, Glandula Suprarenalis Bovinum, Spleen, Carduus Marianus, Natrum Muriaticum LIQUID ORAL 20130401 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; SILYBUM MARIANUM SEED; SODIUM CHLORIDE; PHOSPHORIC ACID 3; 3; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0005_6250d719-24ae-48a0-a88f-247ce93767c7 43772-0005 HUMAN OTC DRUG Oligo Iodine Chelidonium Majus, Spongia Tosta, Iodium, Fucus Vesiculosus, Germanium Sesquioxide, Thyroidinum, Calcarea Carbonica LIQUID ORAL 20130401 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CHELIDONIUM MAJUS; SPONGIA OFFICINALIS SKELETON, ROASTED; IODINE; FUCUS VESICULOSUS; GERMANIUM SESQUIOXIDE; SUS SCROFA THYROID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; POTASSIUM IODIDE; PULSATILLA VULGARIS; CYSTEINE; SODIUM DIETHYL OXALACETATE; FUMARIC ACID; .ALPHA.-KETOGLUTARIC ACID; MANGANESE GLUCONATE; BOS TAURUS PITUITARY GLAND; GOLD; MOLYBDENUM; PALLADIUM; MERCURIUS SOLUBILIS; SILVER; TIN; ZINC; COPPER; NICKEL; EUGENOL; FORMALDEHYDE; TITANIUM; LIDOCAINE; RANCID BEEF; VANADIUM; BROMINE; CALCIUM IODIDE; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; HUMAN COXSACKIEVIRUS B1 3; 3; 4; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43772-0006_f8b061be-7ba8-470e-8b24-1d68cd669d2d 43772-0006 HUMAN OTC DRUG Krebs Stimulator Plus Tabebuia Impetiginosa, Uncaria Tomentosa, Hypothalamus, Pituitaria Glandula, Glandula Suprarenalis Suis, Nadidum LIQUID ORAL 20130401 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. TABEBUIA IMPETIGINOSA BARK; CAT'S CLAW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA ADRENAL GLAND; NADIDE; LACTIC ACID, DL-; LACTIC ACID, L-; COENZYME A; UBIDECARENONE; GERMANIUM SESQUIOXIDE; ADENOSINE TRIPHOSPHATE 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0007_a6bdcc64-44a0-4d0f-a244-bfa178842426 43772-0007 HUMAN OTC DRUG Virosode Cinchona Officinalis, Hydrastis Canadensis, Lomatium Dissectum, Nasturtium Aquaticum, Nux Moschata, Tabebuia Impetiginosa LIQUID ORAL 20121204 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc CINCHONA OFFICINALIS BARK; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; NASTURTIUM OFFICINALE; NUTMEG; TABEBUIA IMPETIGINOSA BARK; CAT'S CLAW; MYRRH; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; LACHESIS MUTA VENOM; BOS TAURUS ADRENAL GLAND; SUS SCROFA THYMUS; STRYCHNOS NUX-VOMICA SEED; ATROPA BELLADONNA WHOLE; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 3; MEASLES VIRUS; POLIOVIRUS; RANCID BEEF; HEPATITIS B VIRUS; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 12; 12; 30; 30; 30; 30; 30; 33; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43772-0008_ba3f3987-f86e-4311-8a04-1622e36fcb93 43772-0008 HUMAN OTC DRUG Viral Plus Arsenicum Album, Belladonna, Echinacea, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lycopodium Clavatum LIQUID ORAL 20130402 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0009_fea9836b-7889-4aae-bd60-4b47330d771f 43772-0009 HUMAN OTC DRUG Calcium Composition Arnica Montana, Echinacea, Boron Gluconate, Symphytum Officinale, Hekla Lava, Calcarea Carbonica LIQUID ORAL 20130402 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ARNICA MONTANA; ECHINACEA, UNSPECIFIED; BORON GLUCONATE; COMFREY ROOT; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; SILICON DIOXIDE 3; 3; 6; 6; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0010_323c98ee-77b5-4706-a8e1-2d3646110c58 43772-0010 HUMAN OTC DRUG Colloidal Silver Colloidal Silver LIQUID ORAL 20130402 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. SILVER 6 [hp_X]/mL N 20181231 43772-0011_2f970ef0-e728-4f2d-b74a-e8b357af69ac 43772-0011 HUMAN OTC DRUG Cerebral Composition Cholinum, Capsicum Annuum, Ginkgo Biloba, Arnica Montana, Gelsemium Sempervirens, Kali Phosphoricum LIQUID ORAL 20130402 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CHOLINE HYDROXIDE; CAPSICUM; GINKGO; ARNICA MONTANA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM PHOSPHATE, DIBASIC; SEMECARPUS ANACARDIUM JUICE; PHOSPHORUS; SEROTONIN; BARIUM CARBONATE 2; 3; 3; 3; 3; 3; 6; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0012_ad6fb804-820b-4a82-b6dc-b8650c49c48e 43772-0012 HUMAN OTC DRUG Allergy Composition Chondrus Crispus, Glycyrrhiza Glabra, Zingiber Officinale, Ambrosia Artemisiaefolia, Histaminum Hydrochloricum, L Dopa LIQUID ORAL 20130417 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CHONDRUS CRISPUS; GLYCYRRHIZA GLABRA; GINGER; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; ETILEVODOPA; SCHOENOCAULON OFFICINALE SEED; TAURINE; IODINE; SODIUM CARBONATE 3; 3; 3; 3; 4; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0013_4ec9d4c2-3249-407d-9c0b-06305c24fe89 43772-0013 HUMAN OTC DRUG Hypothalamus Tincture Aralia Quinquefolia, Hydrocotyle Asiatica, Polygonum Multiflorum, Hypothalamus, Pituitary, Germanium Sesquioxide LIQUID ORAL 20130418 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. AMERICAN GINSENG; CENTELLA ASIATICA; FALLOPIA MULTIFLORA ROOT; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; GERMANIUM SESQUIOXIDE; SUS SCROFA PINEAL GLAND 3; 3; 3; 8; 8; 12; 14 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0014_fe88fc96-db0d-4c4d-b7cc-c2999ac09b31 43772-0014 HUMAN OTC DRUG ALLERSODE II Allium Cepa, Ambrosia Artemisiaefolia, Euphrasia Officinalis, Sabadilla, Alfalfa, American Elm, American Sycamore, Ash, American Beech, Black Walnut, Black Willow, Box Elder, Eastern Cottonwood, False Ragweed, Giant Ragweed, Goldenrod, Kentucky Bluegrass, Orchard Grass, Red Birch, Red Clover, Red Oak, Redtop Grass, Hickory, Sheep Sorrel, Short Ragweed, Timothy Grass, Western Ragweed, Yellow Dock, Glandula Suprarenalis Suis, Hepar Suis, Histaminum Hydrochloricum, Arsenicum Album, Phosphorus LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ONION; AMBROSIA ARTEMISIIFOLIA; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; POA PRATENSIS TOP; DACTYLIS GLOMERATA TOP; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIFOLIUM PRATENSE FLOWER; ALFALFA; AMBROSIA TRIFIDA POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ULMUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; BETULA OCCIDENTALIS POLLEN; QUERCUS RUBRA POLLEN; CARYA OVATA POLLEN; SUS SCROFA ADRENAL GLAND; PORK LIVER; HISTAMINE DIHYDROCHLORIDE; ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR 3; 6; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0015_ea2db6e4-bc52-4a3a-91cb-91b8fceb4b53 43772-0015 HUMAN OTC DRUG Amoebasode Triticum Aestivum, Cajuputum, Baptisia Tinctoria, Capsicum Annuum, Fragaria Vesca, Frasera Caroliniensis, Quassia Amara, Senna LIQUID ORAL 20130813 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. TRITICUM AESTIVUM WHOLE; CAJUPUT OIL; BAPTISIA TINCTORIA; CAPSICUM; ALPINE STRAWBERRY; FRASERA CAROLINIENSIS ROOT; QUASSIA AMARA WOOD; SENNA LEAF; WORMWOOD; BEEF LIVER; BOS TAURUS SPLEEN; BOS TAURUS ADRENAL GLAND; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; AMOEBA PROTEUS; GIARDIA LAMBLIA 1; 1; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 12; 12; 8; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43772-0016_3d08a10b-272c-4808-b0bf-8d153eefd899 43772-0016 HUMAN OTC DRUG FNGSODE Ceanothus Americanus, Condurango, Echinacea, Hydrastis Canadensis, Ligusticum Porteri, Lomatium Dissectum, Nasturtium Aquaticum LIQUID ORAL 20130812 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CEANOTHUS AMERICANUS LEAF; MARSDENIA CONDURANGO BARK; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; ASTRAGALUS PROPINQUUS ROOT; PROPOLIS WAX; SODIUM BORATE; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; BOS TAURUS ADRENAL GLAND; PORK KIDNEY; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; CANDIDA ALBICANS 1; 3; 3; 3; 3; 3; 3; 3; 6; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0017_878e6165-29db-4ff2-a041-c7dbfb342273 43772-0017 HUMAN OTC DRUG Bronchi Plus not applicable LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ACTIVATED CHARCOAL; COPPER; DROSERA ROTUNDIFOLIA; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0018_0cd11851-8428-45e4-8a32-a26b8f67596a 43772-0018 HUMAN PRESCRIPTION DRUG DepressionComposition Cholinum, Inositol, Lithium Carbonicum, Pulsatilla, Ignatia Amara, GABA, Pituitaria Glandula (Suis), Pineal (Suis), Dopamine, Serotonin LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CHOLINE HYDROXIDE; INOSITOL; LITHIUM CARBONATE; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; .GAMMA.-AMINOBUTYRIC ACID; SUS SCROFA PITUITARY GLAND; SUS SCROFA PINEAL GLAND; DOPAMINE; SEROTONIN; GOLD; SODIUM CHLORIDE; PETROSELINUM CRISPUM; SULFUR 3; 3; 3; 3; 3; 4; 6; 6; 12; 12; 12; 12; 60; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Mood Stabilizer [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 43772-0020_961692f4-f0d7-4095-b49f-87dc00dfa924 43772-0020 HUMAN OTC DRUG Bacsode Hydrastis Canadensis, Tabebuia Impetiginosa, Belladonna, Thymus (Bovine), Thymus (Bovine), Glandula Suprarenalis Bovine, Spleen (Bovine) LIQUID ORAL 20130827 UNAPPROVED HOMEOPATHIC Synergy Formulas GOLDENSEAL; MYRRH; TABEBUIA IMPETIGINOSA BARK; ATROPA BELLADONNA; BOS TAURUS THYMUS; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; HYPERICUM PERFORATUM; PHOSPHORUS; CROTALUS HORRIDUS HORRIDUS VENOM; LOMATIUM DISSECTUM ROOT; BOTULINUM TOXIN TYPE A; CHLAMYDIA TRACHOMATIS; CLOSTRIDIUM TETANI; ESCHERICHIA COLI; NEISSERIA MENINGITIDIS; PASTEURELLA MULTOCIDA; STREPTOCOCCUS PNEUMONIAE; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; STAPHYLOCOCCUS AUREUS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 3; 3; 3; 6; 8; 8; 8; 12; 12; 12; 12; 18; 18; 18; 18; 18; 18; 18; 18; 18; 18; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0021_8a825f9d-8892-45bb-b404-8537ccb0bbae 43772-0021 HUMAN OTC DRUG Lymesode Chelidonium majus, Echinacea (Angustifolia), Hydrastis canadensis, Nasturtium aquaticum, Taraxacum officinale, Trifolium pratense, Rhus toxicodendron, Arnica montana, LIQUID ORAL 20140623 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; NASTURTIUM AQUATICUM; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA THYMUS; OXALIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; LATRODECTUS MACTANS; BORRELIA BURGDORFERI; JAPANESE ENCEPHALITIS VIRUS; NEISSERIA MENINGITIDIS; HEPATITIS B VIRUS 3; 3; 3; 3; 3; 3; 5; 6; 6; 6; 6; 6; 8; 8; 12; 12; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0022_5d649e00-ea5d-421c-88f9-322f5c65d5f3 43772-0022 HUMAN OTC DRUG Kidney Tincture Berberis Vulgaris, petroselinum Sativum, Soldago Virgaurea, Uva-Ursi, Glutathione, Rubia Tinctorum, Bryonia, Eupatorium Purpureum, Hydrangea Arborescens LIQUID ORAL 20140102 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. BERBERIS VULGARIS ROOT BARK; PETROSELINUM CRISPUM; SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; GLUTATHIONE; RUBIA TINCTORUM ROOT; BRYONIA ALBA ROOT; EUPATORIUM PURPUREUM ROOT; HYDRANGEA ARBORESCENS ROOT; MERCURIC CHLORIDE; PORK KIDNEY 3; 3; 3; 3; 5; 5; 12; 12; 12; 12; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0023_e3172295-efd9-4015-942f-b9f3d5c62002 43772-0023 HUMAN OTC DRUG Rescue 30C-200C Clematis Vitalba, Helianthemum Nummularium, Impatiens Glandulifera, Ornithogalum Umbellatum, Prunus Cerasifera LIQUID ORAL 20140110 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43772-0024_0837f6b5-7c5b-448c-be24-aaf6ebbb5ea3 43772-0024 HUMAN OTC DRUG Drainage Composition Shark Cartilage, Scrophularia Nodosa, Echinacea, Phytolacca Decandra, Germanium Sesquioxide, Calcarea Iodata, Lymph, Spleen, Thuja Occidentalis, LIQUID ORAL 20140110 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. SHARK CARTILAGE; SCROPHULARIA NODOSA; ECHINACEA, UNSPECIFIED; PHYTOLACCA AMERICANA ROOT; GERMANIUM SESQUIOXIDE; CALCIUM IODIDE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; THUJA OCCIDENTALIS LEAF; CAPSICUM; SULFUR IODIDE; NITRIC ACID 6; 1; 2; 3; 12; 3; 6; 6; 4; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0025_8b08f488-cde5-4c35-b7ab-04f57c017660 43772-0025 HUMAN OTC DRUG Vermasode Abrotanum, Artemisia Vulgaris, Cina, Juglans Nigra, Spigelia Anthelmia, Teucrium Marum, Sabadilla, Silicea, Tanacetum Vulgare, Graphites, Influenzinum, Morbillinum, Diphtherinum, Mononucleosis Virus Nosode, Epstein-Barr Virus Nosode, Herpes Zoster Nosode, Poliomyelitis Nosode, Haemophilus, Hepatitis A Nosode, Hepatitis C Nosode, Pneumococcinum, Coxsackie A2, A7, B1, B3, B4 Nosode LIQUID ORAL 20150116 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA VULGARIS ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; BLACK WALNUT; SPIGELIA ANTHELMIA; TEUCRIUM MARUM; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; TANACETUM VULGARE TOP; GRAPHITE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; DIPHTHERIAL RESPIRATORY PSEUDOMEMBRANE HUMAN; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 3; POLIOVIRUS; HAEMOPHILUS INFLUENZAE TYPE B; HEPATITIS A VIRUS; HEPATITIS C VIRUS; STREPTOCOCCUS PNEUMONIAE; HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B3; HUMAN COXSACKIEVIRUS B4 3; 3; 3; 3; 3; 3; 3; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 200; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43772-0027_ef51844a-15ef-4cd0-a6ae-063249da4e29 43772-0027 HUMAN OTC DRUG Krebs Stimulator Plus Tabebuia impetiginosa, Uncaria tomentosa, Hypothalamus (Suis), Pituitaria glandula (Suis), Glandula suprarenalis suis, Nadidum, Lacticum acidum, Sarcolacticum acidum, LIQUID ORAL 20140623 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. TABEBUIA IMPETIGINOSA BARK; CAT'S CLAW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA ADRENAL GLAND; NADIDE; LACTIC ACID, L-; COENZYME A; UBIDECARENONE; GERMANIUM SESQUIOXIDE; ADENOSINE TRIPHOSPHATE DISODIUM 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0028_1ec7d7a4-5da7-4a3c-9fc7-1a9639d06818 43772-0028 HUMAN OTC DRUG INJURY COMPOSITION Calendula Officinalis, Arnica Montana, Symphytum Officinale, Medulla Ossis Suis, Belladonna, Hamamelis Virginiana, Hypericum Perforatum, Rhus Toxicodendron, Ruta Graveolens, Veratrum Album LIQUID ORAL 20150116 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; COMFREY ROOT; SUS SCROFA BONE MARROW; ATROPA BELLADONNA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; VERATRUM ALBUM ROOT 3; 3; 5; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0029_5cd4d296-8f21-4c1d-b84b-f0a2a6a251d9 43772-0029 HUMAN OTC DRUG HEPATITIS-SODE Triticum Aestivum, Berberis Vulgaris, Chelidonium Majus, Taraxacum Officinale, Arsenicum Album, Glutathione, Hepar Suis, Lymph (Suis), Phosphoricum Acidum, Spleen (Suis), Chelone Glabra, Germanium Sesquioxide, Hepatitis A Nosode, Hepatitis C Nosode, Hepatitis B Nosode LIQUID ORAL 20150119 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. TRITICUM AESTIVUM WHOLE; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; TARAXACUM OFFICINALE; ARSENIC TRIOXIDE; GLUTATHIONE; PORK LIVER; SUS SCROFA LYMPH; PHOSPHORIC ACID; SUS SCROFA SPLEEN; CHELONE GLABRA; GERMANIUM SESQUIOXIDE; HEPATITIS A VIRUS; HEPATITIS C VIRUS; HEPATITIS B VIRUS 1; 3; 3; 3; 6; 6; 6; 6; 6; 6; 6; 8; 18; 18; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0030_7be650af-c8d8-4d05-a6e6-144e84f01a5e 43772-0030 HUMAN OTC DRUG Nerve Plus Composition Agaricus Muscarius, Symphytum Officinale, Hypericum Perforatum, Arnica Montana LIQUID ORAL 20140311 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. AMANITA MUSCARIA FRUITING BODY; COMFREY ROOT; HYPERICUM PERFORATUM; ARNICA MONTANA; PHOSPHORUS; EGG PHOSPHOLIPIDS; PORK BRAIN; LEAD; NAJA NAJA VENOM; ARSENIC TRIOXIDE 3; 3; 3; 3; 4; 8; 8; 8; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0032_05de1caa-fff4-4d32-9739-fc240901a41f 43772-0032 HUMAN OTC DRUG Ear Inflammation Plus Belladonna, Conium maculatum, Dulcamara, Hepar sulphuris calcareum, Kali bichromicum, Mercurius solubilis, Pulsatilla (Vulgaris), LIQUID ORAL 20140513 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ATROPA BELLADONNA; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; CALCIUM SULFIDE; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SILICON DIOXIDE; MATRICARIA RECUTITA 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43772-0033_60153664-0279-43a5-b87b-04659c74477c 43772-0033 HUMAN OTC DRUG Liver Tonic 3 Boldo, Carduus Marianus, Taraxacum Officinale, Ceanothus Americanus, Quassia (Amara), Raphanus Sativus, Phosphorus, Cholesterinum, Benzinum, Leptandra Virginica, Arsenicum Album, Germanium Sesquioxide, Adenosinum Triphosphoricum Dinatrum, Manganum Metallicum, Colibacillinum Cum Natrum Muriaticum, Salmonella Typhi LIQUID ORAL 20140520 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. PEUMUS BOLDUS LEAF; MILK THISTLE; TARAXACUM OFFICINALE; CEANOTHUS AMERICANUS LEAF; QUASSIA AMARA WOOD; RADISH; PHOSPHORUS; CHOLESTEROL; BENZENE; VERONICASTRUM VIRGINICUM ROOT; ARSENIC TRIOXIDE; GERMANIUM SESQUIOXIDE; ADENOSINE TRIPHOSPHATE DISODIUM; MANGANESE; ESCHERICHIA COLI; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 1; 1; 1; 2; 3; 3; 4; 6; 6; 6; 6; 8; 8; 8; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0034_0d832a90-0cf0-439f-9871-d10adfb700f5 43772-0034 HUMAN OTC DRUG Drainage Composition Scrophularia nodosa, Echinacea (Angustifolia), Phytolacca decandra, Calcarea iodate, Thuja occidentalis, Capsicum annuum, Shark cartilage, LIQUID ORAL 20140602 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. SCROPHULARIA NODOSA; ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; CALCIUM IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; CAPSICUM; SHARK CARTILAGE; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; GERMANIUM SESQUIOXIDE; SULFUR IODIDE; NITRIC ACID 1; 2; 3; 3; 4; 6; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0035_369ac386-1ac5-457e-8834-33f30d088443 43772-0035 HUMAN OTC DRUG ADRENAL TINCTURE Chelidonium Majus, Echinacea(Angustifolia), Glandula Suprarenalis Bovine, Spleen(bovine), Carduus Marianus, Natrum Muriaticum, Phosporicum Acidum LIQUID ORAL 20140707 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; MILK THISTLE; SODIUM CHLORIDE; PHOSPHORIC ACID 3; 3; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0036_71376217-7ef1-4312-a81b-0c612cad4661 43772-0036 HUMAN OTC DRUG Cerebral Composition Cholinum, Capsicum Annuum, Ginkgo Biloba, Arnica Montana, Gelsemium Sempervirens, Kali Phosphoricum, Anacardium Orientale, Phosphorus, Serotonin (Hydrochloride, Baryta Carbonica LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CHOLINE HYDROXIDE; CAPSICUM; GINKGO; ARNICA MONTANA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM PHOSPHATE, DIBASIC; ANACARDIUM OCCIDENTALE FRUIT; PHOSPHORUS; SEROTONIN HYDROCHLORIDE; BARIUM CARBONATE 2; 3; 3; 3; 3; 3; 6; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0037_1714ac26-b447-45a7-a43d-b24f789f3963 43772-0037 HUMAN OTC DRUG Calcium Composition Arnica Montana, Echinacea (Angustifolia), Boron Glucconate, Symphytum Officinale, Hekla Lava, Calcarea Carbonica, Clacarea Fluorica, Calcarea phosphorica, Lycopodium Clavatum, Silicea. LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc ARNICA MONTANA; ECHINACEA ANGUSTIFOLIA; BORON GLUCONATE; COMFREY ROOT; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; SILICON DIOXIDE 3; 3; 6; 6; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0038_4b58c4de-2677-4791-ac10-a3119fe7923b 43772-0038 HUMAN OTC DRUG Lymesode Echinacea (Angustifolia), Hydrastis Canadensis, Lycopodium Clavatum, Nasturtium Aquaticum, Taraxacum Officinale, Trifolium Pratense, Rhus Tox, Arnica Montana, Glandula Suprarenalis Suis, Medulla Ossis Suis, Thymus (Suis), Oxalicum Acidum, Magnesia Phosphorica, Latrodectus Mactans, Borrelia Burgdorferi Nosode, Encephalitis Nosode, Meningococcus Nosode, Hepatitis B Nosode LIQUID ORAL 20140715 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; NASTURTIUM OFFICINALE; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA; SUS SCROFA ADRENAL GLAND; SUS SCROFA BONE MARROW; SUS SCROFA THYMUS; OXALIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; LATRODECTUS MACTANS; BORRELIA BURGDORFERI; JAPANESE ENCEPHALITIS VIRUS; NEISSERIA MENINGITIDIS; HEPATITIS B VIRUS 3; 3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 6; 8; 8; 12; 12; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0039_1c7bf590-c837-47ff-a727-a9eab7e0c54a 43772-0039 HUMAN OTC DRUG Adrenal Tincture not applicable LIQUID ORAL 20140718 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ECHINACEA ANGUSTIFOLIA; EPINEPHRINE; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; MILK THISTLE; SODIUM CHLORIDE; PHOSPHORIC ACID 3; 8; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0040_482521c8-da2b-4a0d-ab91-65301d9bca6c 43772-0040 HUMAN OTC DRUG Viral Plus not applicable LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL N 20181231 43772-0041_30ad7cb1-7a50-45db-83c3-3d7fbf35b736 43772-0041 HUMAN OTC DRUG Oligo Iodine NOT APPLICABLE LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. SPONGIA OFFICINALIS SKELETON, ROASTED; IODINE; FUCUS VESICULOSUS; GERMANIUM SESQUIOXIDE; SUS SCROFA THYROID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; POTASSIUM IODIDE; PULSATILLA VULGARIS; BOS TAURUS PITUITARY GLAND; CYSTEINE; SODIUM DIETHYL OXALACETATE; FUMARIC ACID; .ALPHA.-KETOGLUTARIC ACID; MANGANESE GLUCONATE; SILVER; GOLD; COPPER; CLOVE; FORMALDEHYDE; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; TIN; TITANIUM; ZINC; RANCID BEEF; VANADIUM; BROMINE; CALCIUM IODIDE; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; HUMAN COXSACKIEVIRUS B1 3; 4; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 14; 30; 30; 30; 30; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0042_8cebcb38-c604-42b0-b905-8ac9142c05d5 43772-0042 HUMAN OTC DRUG HYPERT PLUS NOT APPLICABLE LIQUID ORAL 20140925 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ARNICA MONTANA; GOLD; SELENICEREUS GRANDIFLORUS STEM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SOLIDAGO VIRGAUREA FLOWERING TOP 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0043_413decba-aced-48bf-9a1e-c4ab644d1c47 43772-0043 HUMAN OTC DRUG DEPRESSION COMPOSITION NOT APPLICABLE LIQUID ORAL 20140926 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CHOLINE HYDROXIDE; INOSITOL; LITHIUM CARBONATE; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; .GAMMA.-AMINOBUTYRIC ACID; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; DOPAMINE HYDROCHLORIDE; SEROTONIN HYDROCHLORIDE; GOLD; SODIUM CHLORIDE; PETROSELINUM CRISPUM; SULFUR 3; 3; 3; 3; 3; 4; 6; 6; 12; 12; 12; 12; 60; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0044_149cd648-cafd-44f7-9277-d7f26b77969d 43772-0044 HUMAN OTC DRUG CALMING COMPOSITION NOT APPLICABLE LIQUID ORAL 20141117 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. HOPS; VALERIAN; AVENA SATIVA FLOWERING TOP; SCUTELLARIA LATERIFLORA; FERULA SUMBUL ROOT; MELILOTUS OFFICINALIS TOP; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; ZINC; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; PULSATILLA VULGARIS; ACONITUM NAPELLUS; FERULA COMMUNIS SUBSP. GLAUCA 1; 1; 1; 2; 3; 3; 3; 6; 6; 8; 8; 8; 8; 30; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43772-0045_736c20a3-2d13-4804-bf64-112dd7de8e16 43772-0045 HUMAN OTC DRUG Adrenal Tincture Chelidonium Majus, Echinacea (Angustifolia), Adrenalinum, Glandula Suprarenalis Bovine, Spleen (Bovine), Carduus Marianus, Natrum Muriaticum, Phosphoricum Acidum LIQUID ORAL 20150202 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; EPINEPHRINE; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; MILK THISTLE; SODIUM CHLORIDE; PHOSPHORIC ACID 3; 3; 8; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0046_ebd589d3-25cc-42de-9517-a51dd230de7a 43772-0046 HUMAN OTC DRUG Virosode Cinchona Officinalis, Hydrastis Canadensis, Lomatium Dissectum, Nasturtium Aquaticum, Nux Moschata, Tabebuia Impetiginosa, Myrrha, Gelsemium Sempervirens, Germanium Sesquioxide, Lachesis Mutus, Glandula Suprarenalis Bovine, Thymus Gland (Suis), Nux Vomica, Belladonna, Epstein-Barr Virus Nosode, Herpes Zoster Nosode, Morbillinum, Poliomyelitis Nosode, Pyrogenium, Hepatitis B Nosode, Coxsackie B1 Nosode, Coxsackie B4 Nosode LIQUID ORAL 20150311 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc CINCHONA OFFICINALIS BARK; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; NASTURTIUM OFFICINALE; NUTMEG; TABEBUIA IMPETIGINOSA BARK; MYRRH; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; LACHESIS MUTA VENOM; BOS TAURUS ADRENAL GLAND; SUS SCROFA THYMUS; STRYCHNOS NUX-VOMICA SEED; ATROPA BELLADONNA WHOLE; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 3; MEASLES VIRUS; POLIOVIRUS; RANCID BEEF; HEPATITIS B VIRUS; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 12; 12; 30; 30; 30; 30; 30; 33; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43772-0047_980ee156-06d4-4959-a121-3620d5c35c56 43772-0047 HUMAN OTC DRUG AMOEBASODE Triticum Aestivum, Cajuputum, Baptisia Tinctoria, Capsicum Annuum, Frasera Caroliniensis, Quassia (Amara), Senna (Cassia Angustifolia), Absinthium, Hepar Bovine, Spleen (Bovine), Glandula Suprarenalis Bovine, Cinchona Officinalis, Lycopodium Clavatum, Amoeba Axis, Giardia Lamblia LIQUID ORAL 20150121 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. TRITICUM AESTIVUM WHOLE; CAJUPUT OIL; BAPTISIA TINCTORIA; CAPSICUM; FRASERA CAROLINIENSIS ROOT; QUASSIA AMARA WOOD; SENNA LEAF; WORMWOOD; BEEF LIVER; BOS TAURUS SPLEEN; BOS TAURUS ADRENAL GLAND; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; AMOEBA PROTEUS; GIARDIA LAMBLIA 1; 1; 3; 3; 3; 3; 3; 6; 8; 8; 8; 12; 12; 8; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43772-0048_76c6e597-b8ef-49f7-b4d7-204f7f66347d 43772-0048 HUMAN OTC DRUG KREBS STIMULATOR PLUS Tabebuia Impetiginosa, Hypothalamus (Suis), Pituitaria Glandula (Suis), Glandula Suprarenalis Suis, Nadidum, Lacticum Acidum, Sarcolacticum Acidum, Coenzyme A, Coenzyme Q-10, Germanium Sesquioxide, Adenosinum Triphosphoricum Dinatrum LIQUID ORAL 20150220 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. TABEBUIA IMPETIGINOSA BARK; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA ADRENAL GLAND; NADIDE; LACTIC ACID, DL-; LACTIC ACID, L-; COENZYME A; UBIDECARENONE; GERMANIUM SESQUIOXIDE; ADENOSINE TRIPHOSPHATE DISODIUM 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0050_e66f34cd-0ca0-4d77-9014-e8817d0347ea 43772-0050 HUMAN OTC DRUG KREBS STIMULATOR PLUS Tabebuia Impetiginosa, Uncaria Tomentosa, Hypothalamus (Suis), Pituitaria Glandula (Suis), Glandula Suprarenalis Suis, Nadidum, Lacticum Acidum, Sarcolacticum Acidum, Coenzyme A, Ubidecarenonun, Germanium Sesquioxide, Adenosinum Triphosphoricum Dinatrum LIQUID ORAL 20150220 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. TABEBUIA IMPETIGINOSA BARK; CAT'S CLAW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA ADRENAL GLAND; NADIDE; LACTIC ACID, DL-; LACTIC ACID, L-; COENZYME A; UBIDECARENONE; GERMANIUM SESQUIOXIDE; ADENOSINE TRIPHOSPHATE DISODIUM 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43772-0052_cda54fe6-29c5-4a32-ab05-2942384c5988 43772-0052 HUMAN OTC DRUG Vaxosode Echinacea (Angustifolia), Baptisia Tinctoria, Chelidonium Majus, Hydrastis Canadensis, Phytolacca Decandra, Tabebuia Impetiginosa, Taraxacum Officinale, Uncaria Tomentosa, Thuja Occidentalis, Calcarea Carbonica, Silicea, Belladonna, Chamomilla, Lycopodium Clavatum, Rhus Tox, Arsenicum Album, Pertussinum LIQUID ORAL 20150319 UNAPPROVED HOMEOPATHIC Synergy Formulas, Inc. ECHINACEA ANGUSTIFOLIA; BAPTISIA TINCTORIA ROOT; CHELIDONIUM MAJUS; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; TABEBUIA IMPETIGINOSA BARK; TARAXACUM OFFICINALE; CAT'S CLAW; THUJA OCCIDENTALIS LEAFY TWIG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; ARSENIC TRIOXIDE; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED 1; 1; 3; 3; 3; 3; 3; 3; 6; 8; 8; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43773-1001_28c87785-4554-4172-9b11-f6a9d72923a8 43773-1001 HUMAN PRESCRIPTION DRUG Testopel TESTOSTERONE PELLET SUBCUTANEOUS 20090721 ANDA ANDA080911 Slate Pharma TESTOSTERONE 75 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 43817-133_9f7248b0-fc58-49d7-bd3c-e71ef6b4779f 43817-133 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20170117 ANDA ANDA204722 Panacea Biotec Ltd RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 43817-135_9f7248b0-fc58-49d7-bd3c-e71ef6b4779f 43817-135 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20170117 ANDA ANDA204722 Panacea Biotec Ltd RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 43817-239_939dce06-52a2-3b91-7ec6-8ce281d5ddda 43817-239 HUMAN PRESCRIPTION DRUG Prasugrel Prasugrel TABLET, FILM COATED ORAL 20171016 ANDA ANDA205897 Panacea Biotec Ltd. PRASUGREL HYDROCHLORIDE 5 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 43817-240_939dce06-52a2-3b91-7ec6-8ce281d5ddda 43817-240 HUMAN PRESCRIPTION DRUG Prasugrel Prasugrel TABLET, FILM COATED ORAL 20171016 ANDA ANDA205897 Panacea Biotec Ltd. PRASUGREL HYDROCHLORIDE 10 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 43817-421_5dc625cf-a0a7-ec11-7a40-76d7dab3f712 43817-421 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20160226 ANDA ANDA090802 Panacea Biotec Ltd TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 43817-422_5dc625cf-a0a7-ec11-7a40-76d7dab3f712 43817-422 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20160226 ANDA ANDA090802 Panacea Biotec Ltd TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 43817-423_5dc625cf-a0a7-ec11-7a40-76d7dab3f712 43817-423 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20160226 ANDA ANDA090802 Panacea Biotec Ltd TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 43825-102_2d647e2d-31d6-419f-819a-318e92b42618 43825-102 HUMAN PRESCRIPTION DRUG Ofirmev acetaminophen INJECTION, SOLUTION INTRAVENOUS 20101108 NDA NDA022450 Mallinckrodt Hospital Products Inc. ACETAMINOPHEN 10 mg/mL N 20181231 43825-606_bd410b51-2420-4b39-acef-397e3664a3ea 43825-606 HUMAN PRESCRIPTION DRUG RECOTHROM Thrombin topical Recombinant KIT 20080129 BLA BLA125248 Mallinckrodt Hospital Products Inc. N 20181231 43825-707_bd410b51-2420-4b39-acef-397e3664a3ea 43825-707 HUMAN PRESCRIPTION DRUG RECOTHROM Thrombin topical Recombinant KIT 20080609 BLA BLA125248 Mallinckrodt Hospital Products Inc. N 20181231 43835-0019_f9271099-7040-4770-b781-19577cbf1be9 43835-0019 LICENSED VACCINE BULK INTERMEDIATE FLUVIRIN A/Singapore/GP1908/2015 IVR-180 (an A/Michigan/45/2015 (H1N1)pdm09-like virus, A/Hong Kong/4801/2014, NYMC X-263B (H3N2) (an A/Hong Kong/4801/2014-like virus), and B/Brisbane/60/2008, wild type (a B/Brisbane/60/2008-like virus) INJECTION, SUSPENSION NOT APPLICABLE 20130915 BLA BLA103837 Catalent Belgium SA INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/HUBEI-WUJIAGANG/158/2009 BX-39 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL N 20191231 43846-0001_00fc93a5-a48b-492b-8aa5-a6a2a876b5bd 43846-0001 HUMAN OTC DRUG Tendon Rescue Bryonia, Ruta Graveolens, Bellis Perennis, Argentum Metallicum GEL TOPICAL 20130321 UNAPPROVED HOMEOPATHIC Peaceful Mountain BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; BELLIS PERENNIS; SILVER 3; 3; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0002_25c5d5b2-c318-45c4-b18b-5267f586c862 43846-0002 HUMAN OTC DRUG Muscle Ice Phytolacca Decandra, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Magnesia Phosphorica, Silicea GEL TOPICAL 20120525 20201111 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE 1; 3; 6; 6; 6; 9; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0003_5f9f7029-5fc3-4948-8b06-5c81b57eb046 43846-0003 HUMAN OTC DRUG Back and Neck Rescue Hypericum Perforatum, Phytolacca Decandra, Guaiacum, Ledum Palustre, Conium Maculatum GEL TOPICAL 20130320 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. HYPERICUM PERFORATUM; PHYTOLACCA AMERICANA ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; CONIUM MACULATUM FLOWERING TOP 3; 3; 6; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0004_ee2fb53f-7a23-42af-9aaf-aa7309256964 43846-0004 HUMAN PRESCRIPTION DRUG MUSCLE RESCUE Arnica Montana, Rhus Toxicodendron, Phytolacca Decandra, Pulsatilla, Ruta Graveolens GEL TOPICAL 20130812 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP 3; 3; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0005_8fa18203-76a9-45e5-bdba-429a72f21f6f 43846-0005 HUMAN OTC DRUG Muscle Ice Phytolacca Decandra, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Magnesia Phosphorica GEL TOPICAL 20130308 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE 1; 3; 6; 6; 6; 9; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0006_3479abcd-f16a-4a87-bab3-35257600d8b0 43846-0006 HUMAN OTC DRUG Tendon Rescue Bryonia, Ruta Graveolens, Bellis Perennis, Argentum Metallicum GEL TOPICAL 20130319 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; BELLIS PERENNIS; SILVER 3; 3; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0007_6669b70c-c932-492c-8cad-b3f8fe0e9997 43846-0007 HUMAN OTC DRUG Hot Flash Rescue Capsicum Annuum, Pulsatilla, Sanguinaria Canadensis SPRAY TOPICAL 20130319 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43846-0008_929c61f4-c0e2-41d9-b601-7ae2779d2ab6 43846-0008 HUMAN OTC DRUG Eczema Rescue Carbolicum Acidum, Fagopyrum Esculentum, Hydrastis Canadensis, Hydrocotyle Asiatica, Juglans Regia, Vinca Minor LOTION TOPICAL 20130319 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHENOL; FAGOPYRUM ESCULENTUM; GOLDENSEAL; CENTELLA ASIATICA; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; VINCA MINOR 30; 30; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0009_d411a613-b8ec-4337-8b56-8e67199277a0 43846-0009 HUMAN OTC DRUG Back and Neck Rescue Hypericum Perforatum, Phytolacca Decandra, Guaiacum, Ledum Palustre, Conium Maculatum GEL TOPICAL 20130319 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. HYPERICUM PERFORATUM; PHYTOLACCA AMERICANA ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; CONIUM MACULATUM FLOWERING TOP 3; 3; 6; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0011_f6d1c1cf-e5e4-4345-a417-9704236f2c4a 43846-0011 HUMAN OTC DRUG Shingles Rescue Althaea Officinalis, Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Toxicodendron GEL TOPICAL 20130319 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ALTHAEA OFFICINALIS ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 12; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0012_e10e78cb-abc3-4a67-a447-14a98d0f9997 43846-0012 HUMAN OTC DRUG ECZEMA RESCUE Carbolicum Acidum, Fagopyrum Esculentum, Hydrastis Canadensis, Hydrocotyle Asiatica, Juglans Regia, Vinca Minor GEL TOPICAL 20150224 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHENOL; FAGOPYRUM ESCULENTUM; GOLDENSEAL; CENTELLA ASIATICA; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; VINCA MINOR 30; 30; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0013_13c53e45-533e-497c-b91d-b07ee22a48ae 43846-0013 HUMAN OTC DRUG Joint Rescue Symphytum Officinale, Capsicum Annuum, Ledum Palustre, Colchicum Autumnale, Rhododendron Chrysanthum GEL TOPICAL 20130318 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. COMFREY ROOT; CAPSICUM; LEDUM PALUSTRE TWIG; COLCHICUM AUTUMNALE BULB; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 3; 6; 6; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0014_b7829672-f079-4d57-9e5a-9ce0b8f87a8b 43846-0014 HUMAN OTC DRUG Sciatic Rescue Phytolacca Decandra, Gnaphalium Polycephalum, Colocynthis, Gelsemium Sempervirens GEL TOPICAL 20120824 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT 1; 3; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0015_d917d881-4cbe-4e36-8ad2-6bb32f38dcb4 43846-0015 HUMAN PRESCRIPTION DRUG Back and Neck Rescue Hypericum Perforatum, Phytolacca Decandra, Guaiacum, Ledum Palustre, Conium Maculatum LOTION TOPICAL 20120919 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. HYPERICUM PERFORATUM; PHYTOLACCA AMERICANA ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; CONIUM MACULATUM FLOWERING TOP 3; 3; 6; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0016_44a61d58-b8ea-452d-8c7a-1ccb569baa84 43846-0016 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Toxicodendron, GEL TOPICAL 20120919 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0017_f034aeb8-147d-4fa4-a874-9db319a0d046 43846-0017 HUMAN OTC DRUG Eczema Rescue Carbolicum Acidum, Fagopyrum Esculentum, Hydrastis Canadensis, Hydrocotyle Asiatica, Juglans Regia, Vinca Minor LOTION TOPICAL 20120914 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHENOL; FAGOPYRUM ESCULENTUM; GOLDENSEAL; CENTELLA ASIATICA; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; VINCA MINOR 30; 30; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0018_65b64e0f-f1c9-454d-a140-5ab9e0c5a622 43846-0018 HUMAN OTC DRUG Muscle Ice Phytolacca Decandra, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Magnesia Phosphorica, Silicea LOTION TOPICAL 20120919 20190820 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE 1; 3; 6; 6; 6; 9; 9 umol/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0019_0ea9984d-0289-43b9-95b2-844e946048cc 43846-0019 HUMAN OTC DRUG ECZEMA RESCUE CABOLICUM ACIDUM, FAGOPYRUM ESCULENTUM, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, JUGLANS REGIA, VINCA MINOR LOTION TOPICAL 20141215 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHENOL; FAGOPYRUM ESCULENTUM; GOLDENSEAL; CENTELLA ASIATICA; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; VINCA MINOR 30; 30; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0020_86c471ba-4d14-454f-9006-dde63b66759e 43846-0020 HUMAN OTC DRUG Back and Neck Rescue Hypericum Perforatum, Phytolacca Decandra, Guaiacum, Ledum Palustre, Conium Maculatum GEL TOPICAL 20130318 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. HYPERICUM PERFORATUM; PHYTOLACCA AMERICANA ROOT; GUAIAC; LEDUM PALUSTRE TWIG; CONIUM MACULATUM FLOWERING TOP 3; 3; 6; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0021_620fa40b-ee6c-48f0-9147-204ebb887d69 43846-0021 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Toxicodendron GEL TOPICAL 20130314 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0022_47398224-62e7-483a-a2a1-bb8b8a2a88fa 43846-0022 HUMAN OTC DRUG Muscle Ice Phytolacca Decandra, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Magnesia Phosphorica, Silicea GEL TOPICAL 20130925 UNAPPROVED HOMEOPATHIC Peaceful Mountain PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE 1; 3; 6; 6; 6; 9; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0023_6f282b64-3db7-44f1-8ca5-836ef9a54676 43846-0023 HUMAN OTC DRUG Tendon Rescue Bryonia, Ruta Graveolens, Bellis Perennis, Argentum Metallicum GEL TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; BELLIS PERENNIS; SILVER 3; 3; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0024_143e28ec-16de-4427-a6cc-02a5b0f1d4e5 43846-0024 HUMAN OTC DRUG Sciatic Rescue Phytolacca Decandra, Gnaphalium Polycephalum, Colocynthis, Gelsemium Sempervirens GEL TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT 1; 3; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0025_84b060ac-7e78-42ef-b463-7b0e240b5cbe 43846-0025 HUMAN OTC DRUG Muscle Rescue Arnica Montana, Rhus Toxicodendron, Phytolacca Decandra, Pulsatilla, Ruta Graveolens GEL TOPICAL 20130318 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP 3; 3; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0026_95fd158c-5cf2-4cfc-8d2b-0500da9128be 43846-0026 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Toxicodendron GEL TOPICAL 20121011 20190410 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0027_89438149-8efb-49e9-854f-7df3b3a3945c 43846-0027 HUMAN OTC DRUG Joint Rescue Symphytum Officinale, Capsicum Annuum, Ledum Palustre, Colchicum Autumnale, Rhododendron Chrysanthum, Ruta Graveolens GEL TOPICAL 20121011 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. COMFREY ROOT; CAPSICUM; LEDUM PALUSTRE TWIG; COLCHICUM AUTUMNALE BULB; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 3; 6; 6; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0028_55fcf47a-8010-4032-8fa6-5732477f7899 43846-0028 HUMAN OTC DRUG Shingles Rescue Plus Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla GEL TOPICAL 20130925 UNAPPROVED HOMEOPATHIC Peaceful Mountain CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0029_67697c06-ea2e-414e-864c-f84c91547fe6 43846-0029 HUMAN OTC DRUG Joint Rescue Symphytum Officinale, Capsicum Annuum, Ledum Palustre, Colchicum Autumnale, Rhododendron Chrysanthum, Ruta Graveolens GEL TOPICAL 20130913 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. COMFREY ROOT; CAPSICUM; LEDUM PALUSTRE TWIG; COLCHICUM AUTUMNALE BULB; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 3; 6; 6; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0030_a24d746c-1ba3-4875-a268-708b662b59b6 43846-0030 HUMAN OTC DRUG Sciatic Rescue Phytolacca Decandra, Gnaphalium Polycephalum, Colocynthis, Gelsemium Sempervirens GEL TOPICAL 20130228 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT 1; 3; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0031_a36d71a6-adaa-4686-98bd-c32971812b24 43846-0031 HUMAN OTC DRUG Cold Sore Rescue BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA GEL TOPICAL 20141208 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. SODIUM BORATE; SOLANUM DULCAMARA TOP; SODIUM CHLORIDE; RANUNCULUS BULBOSUS; SILICON DIOXIDE 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0032_29017b5e-2385-423e-a4b0-63ff641b269c 43846-0032 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Toxicodendron LOTION TOPICAL 20130104 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0033_1ff980df-19d7-4286-bc2d-7e441a534fe7 43846-0033 HUMAN OTC DRUG Hot Flash Rescue Capsicum Annuum, Pulsatilla, Sanguinaria Candensis LOTION TOPICAL 20140102 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0034_fd3f1842-31de-4f03-9ee6-79e852ae20bb 43846-0034 HUMAN OTC DRUG Back and Neck Rescue Hypericum Perforatum, Phytolacca Decandra, Guaiacum, Ledum Palustre, Conium Maculatum GEL TOPICAL 20130417 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. HYPERICUM PERFORATUM; PHYTOLACCA AMERICANA ROOT; GUAIAC; LEDUM PALUSTRE TWIG; CONIUM MACULATUM FLOWERING TOP 3; 3; 6; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0035_5489e385-a114-4757-80c7-1688aaaa5cf2 43846-0035 HUMAN OTC DRUG MUSCLE RESCUE Arnica Montana, Rhus Toxicodendron, Phytolacca Decandra, Pulsatilla, Ruta Graveolens GEL TOPICAL 20130807 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP 3; 3; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0036_0261565f-f41b-4c8a-a2be-63aeecb293cf 43846-0036 HUMAN OTC DRUG HOT FLASH RESCUE NOT APPLICABLE LOTION TOPICAL 20141001 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0037_8b66f47d-0914-4050-b230-e89d6e439e1d 43846-0037 HUMAN OTC DRUG Chafe Rescue Bryonia, Arsenicum Iodatum, Baryta Carbonica, Alumina, Calendula Officinalis, Sulphuricum Acidum, Symphytum Officinale LOTION TOPICAL 20140102 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc BRYONIA ALBA ROOT; ARSENIC TRIIODIDE; BARIUM CARBONATE; ALUMINUM OXIDE; CALENDULA OFFICINALIS FLOWERING TOP; SULFURIC ACID; COMFREY ROOT 1; 6; 8; 12; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0039_4301f4e3-3dde-4df2-b3bf-0ce5f1ab5d86 43846-0039 HUMAN OTC DRUG Acne Rescue Borax, Carbo Vegetabilis, Carboneum Sulphuratum, Causticum, Natrum Muriaticum, Silicea GEL TOPICAL 20141229 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. SODIUM BORATE; ACTIVATED CHARCOAL; CARBON DISULFIDE; CAUSTICUM; SODIUM CHLORIDE; SILICON DIOXIDE 30; 12; 12; 12; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20191231 43846-0040_0f2f3628-1cca-45af-b61b-41dcd01d08c8 43846-0040 HUMAN OTC DRUG Acne Rescue Borax, Carbo Vegetabilis, Carboneum Sulphuratum, Causticum, Natrum Muriaticum, Silicea GEL TOPICAL 20140710 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. SODIUM BORATE; ACTIVATED CHARCOAL; CARBON DISULFIDE; CAUSTICUM; SODIUM CHLORIDE; SILICON DIOXIDE 30; 12; 12; 12; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0041_d05a3bcb-5f25-4cc7-b11e-c7c3002519ef 43846-0041 HUMAN OTC DRUG Headache Pain and Sinus Pressure Relief Calendula officinalis, Croton Tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20141231 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43846-0042_3d9380b4-cf6d-4fb3-b32d-48be8b62c856 43846-0042 HUMAN OTC DRUG Joint Pain and Stiffness Relief Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20150107 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43846-0043_245c3b72-6381-422f-b308-b055ae2a310b 43846-0043 HUMAN OTC DRUG MUSCLE/TENDON PAIN AND STRESS RELIEF Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20141230 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43846-0044_3f6ee082-0631-499b-93d1-2fb822183a16 43846-0044 HUMAN OTC DRUG SHINGLES PAIN ULCERATION RELIEF Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20150105 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43846-0045_749c3e20-bc34-447a-a8c3-a7a5d6ffdc72 43846-0045 HUMAN OTC DRUG First Aid Pain and Trauma Relief Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20141230 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43846-0046_d8dbf48c-3a12-4d33-a6fd-92dc894bca38 43846-0046 HUMAN OTC DRUG Skin Irritant and Healing Support Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20150107 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43846-0050_043a9f6c-c9b2-4556-9157-06e5e9f0f703 43846-0050 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Tox GEL TOPICAL 20160509 20210126 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0051_b99229fb-1328-4d03-aa4b-a09fc92dfabe 43846-0051 HUMAN OTC DRUG Muscle Ice Phytolacca Decandra, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Magnesia Phosphorica, Silicea, Menthol (Crystals) GEL TOPICAL 20160426 20210916 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE; MENTHOL 1; 3; 6; 6; 6; 9; 9; 700 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; g/g N 20181231 43846-0052_e5676ea4-2f6f-4ee3-9d97-be3c912736fb 43846-0052 HUMAN OTC DRUG Muscle Rescue Arnica Montana, Rhus Tox, Whey Protein, Phytolacca Decandra, Pulsatilla (Vulgaris), Ruta Graveolens GEL TOPICAL 20160707 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; WHEY; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP 3; 3; 6; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0053_4ab32781-c508-470f-897c-3c47da641f6d 43846-0053 HUMAN OTC DRUG Pain Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20170425 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43846-0054_6c944aed-1de3-491c-bff9-8b87e1f11d2c 43846-0054 HUMAN OTC DRUG Joint Pain Stiffness Relief Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20151124 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43846-0055_0d7170e6-ed67-4724-b762-db020f81bd07 43846-0055 HUMAN OTC DRUG Muscle/Tendon Pain Stress Relief Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20151124 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43846-0056_665fba8f-2c3a-46bf-80e0-f0dae37346f8 43846-0056 HUMAN OTC DRUG Shingles Pain Ulceration Relief Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20151125 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43846-0057_5381adc0-8a83-48f5-89f8-c902155183f5 43846-0057 HUMAN OTC DRUG Back, Neck and Sciatic Rescue Phytolacca Decandra, Gnaphalium Polycephalum, Hypericum Perforatum, Colocynthis, Gelsemium Sempervirens, Guaiacum, Ledum Palustre, Whey Protein, Conium Maculatum GEL TOPICAL 20160804 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; WHEY; CONIUM MACULATUM FLOWERING TOP 1; 3; 3; 6; 6; 6; 6; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0058_de74c8cf-a60f-48fe-ab33-2fe06bc7bf82 43846-0058 HUMAN OTC DRUG Joint and Tendon Rescue Bryonia (Alba), Ruta Graveolens, Bellis Perennis, Capsicum Annuum, Ledum Palustre, Symphytum Officinale, Whey Protein, Colchicum Autumnale, Rhododendron Chrysanthum, Argentum Metallicum GEL TOPICAL 20160805 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; BELLIS PERENNIS; CAPSICUM; LEDUM PALUSTRE TWIG; COMFREY ROOT; WHEY; COLCHICUM AUTUMNALE BULB; RHODODENDRON AUREUM LEAF; SILVER 3; 3; 6; 6; 6; 6; 6; 12; 12; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0059_530a2ae8-9bf9-47b5-b259-62a587914038 43846-0059 HUMAN OTC DRUG Shingles Pain Relief Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) LIQUID TOPICAL 20160324 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43846-0060_cc9415ce-40e7-492a-8743-83cd01ee5e46 43846-0060 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Tox GEL TOPICAL 20160509 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0061_5dc70e29-4382-49b2-a8a9-0de62be1b3a7 43846-0061 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Tox, Whey Protein GEL TOPICAL 20160719 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF; WHEY 6; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0062_6c9b7477-d1e5-4879-927c-f96a3e580c43 43846-0062 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Tox, Whey Protein GEL TOPICAL 20160719 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA BARK; TOXICODENDRON PUBESCENS LEAF; WHEY 6; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0063_08234466-8b13-4d02-b9ea-1f711982d8bf 43846-0063 HUMAN OTC DRUG Muscle Ice Phytolacca Decandra, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Symphytum Officinale, Whey Protein, Magnesia Phosphorica, Silicea GEL TOPICAL 20160804 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHYTOLACCA AMERICANA ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; WHEY; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE 1; 6; 6; 6; 6; 6; 9; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0064_68be852c-51dd-4698-b6fd-161cc27df060 43846-0064 HUMAN OTC DRUG Muscle Ice Phytolacca Decandra, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Symphytum Officinale, Whey Protein, Magnesia Phosphorica, Silicea, Menthol (Crystals) GEL TOPICAL 20161017 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHYTOLACCA AMERICANA ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; WHEY; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE; MENTHOL 1; 6; 6; 6; 6; 6; 9; 9; .04 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; g/g N 20181231 43846-0065_f08bdda0-7eda-4ded-98e3-0d42d3a87e72 43846-0065 HUMAN OTC DRUG Arnica Plus Arnica Montana, Hamamelis Virginiana, Rhus Tox, Whey Protein GEL TOPICAL 20160720 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. ARNICA MONTANA; HAMAMELIS VIRGINIANA BARK; TOXICODENDRON PUBESCENS LEAF; WHEY 6; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0066_cdbb733c-130a-4e55-bcbf-a1106cd81ed5 43846-0066 HUMAN OTC DRUG Back, Neck and Sciatic Rescue Phytolacca Decandra, Gnaphalium Polycephalum, Hypericum Perforatum, Colocynthis, Gelsemium Sempervirens, Guaiacum, Ledum Palustre, Whey Protein, Conium Maculatum GEL TOPICAL 20160914 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; WHEY; CONIUM MACULATUM FLOWERING TOP 1; 3; 3; 6; 6; 6; 6; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43846-0067_1aa94085-5f4c-4d4d-bbc0-4d27739797cb 43846-0067 HUMAN OTC DRUG Muscle Ice Phytolacca Decandra, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Magnesia Phosphorica, Silicea, Menthol (Crystals) GEL TOPICAL 20160914 UNAPPROVED HOMEOPATHIC Peaceful Mountain, Inc. PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE; MENTHOL 1; 3; 6; 6; 6; 9; 9; 844 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; g/g N 20181231 43853-0001_8cc56347-a99b-4a87-8684-96dca3ad9761 43853-0001 HUMAN OTC DRUG Estrogen and Progesterone Agnus Castus, Angelica Sinensis, Apis Mellifica, Arnica Montana, Cimicifuga Racemosa, Estradiol, Estriol, Folliculinum, Galium Aparine, Glycyrrhiza Glabra, Korean Ginseng, Oophorinum (Suis), Progesterone, Sepia, Thuja Occidentalis, Viscum Album SPRAY ORAL 20140205 20201221 UNAPPROVED HOMEOPATHIC ProBLEN CHASTE TREE; ANGELICA SINENSIS ROOT; APIS MELLIFERA; ARNICA MONTANA; BLACK COHOSH; ESTRADIOL; ESTRIOL; ESTRONE; GALIUM APARINE; GLYCYRRHIZA GLABRA; ASIAN GINSENG; SUS SCROFA OVARY; PROGESTERONE; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAF; VISCUM ALBUM FRUITING TOP 3; 3; 6; 6; 3; 9; 9; 9; 3; 3; 3; 30; 6; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43853-0002_1238fc40-6be3-4dd5-82e2-f6f093226615 43853-0002 HUMAN OTC DRUG HGH Plus IGF1 and IGF2 Arnica Montana, Deer Antler Velvet, Hepar Bovine, HGH, IGF, Pituitaria Glandula Bovine, Thuja Occidentalis LIQUID ORAL 20130917 20180306 UNAPPROVED HOMEOPATHIC ProBLEN ARNICA MONTANA; CERVUS ELAPHUS VELVET; BEEF LIVER; SOMATROPIN; MECASERMIN; BOS TAURUS PITUITARY GLAND; THUJA OCCIDENTALIS LEAF 6; 8; 6; 24; 8; 5; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 43853-0005_d9dbabaa-579a-4f96-aef3-cb23ff36e0c8 43853-0005 HUMAN OTC DRUG Testosterone Avena Sativa, Carduus Marianus, Damiana, Galium Aparine, Hamamelis Virginiana, Hepar Bovine, Korean Ginseng, Nuphar Luteum, Orchitinum (Bovine), Populus Tremuloides, Testosterone, Thuja Occidentalis LIQUID ORAL 20130916 UNAPPROVED HOMEOPATHIC ProBLEN AVENA SATIVA FLOWERING TOP; SILYBUM MARIANUM SEED; TURNERA DIFFUSA LEAFY TWIG; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; BEEF LIVER; ASIAN GINSENG; NUPHAR LUTEUM ROOT; BOS TAURUS TESTICLE; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; TESTOSTERONE; THUJA OCCIDENTALIS LEAF 1; 1; 1; 3; 1; 6; 1; 2; 6; 1; 1; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43853-0006_f938b86b-ef23-48cb-abb6-859564c97e3f 43853-0006 HUMAN OTC DRUG Thyroid Calcarea Iodata, Ferrum Metallicum, Fucus Vesiculosus, Lapis Albus, Natrum Muriaticum, Spongia Tosta LIQUID ORAL 20130228 UNAPPROVED HOMEOPATHIC ProBLEN CALCIUM IODIDE; IRON; FUCUS VESICULOSUS; CALCIUM HEXAFLUOROSILICATE; SODIUM CHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID 30; 12; 3; 30; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43853-0007_ddfc5ce5-5954-4f9f-a703-adcc1090ecdf 43853-0007 HUMAN OTC DRUG HGH HGH, Hepar Bovinum, Pituitary Bovinum LIQUID ORAL 20130306 20201110 UNAPPROVED HOMEOPATHIC ProBLEN SOMATROPIN; BEEF LIVER; BOS TAURUS PITUITARY GLAND 30; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43853-0008_3992ec41-9aae-4e88-83be-6032a43e5d77 43853-0008 HUMAN OTC DRUG Adrenal and DHEA Aralia Quinquefolia, Arnica Montana, Avena Sativa, Carduus Marianus, Dhea, Glandula Suprarenalis Suis, L-Arginine LIQUID ORAL 20130423 UNAPPROVED HOMEOPATHIC ProBLEN AMERICAN GINSENG; ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; SILYBUM MARIANUM SEED; PRASTERONE; SUS SCROFA ADRENAL GLAND; ARGININE; SODIUM CHLORIDE; PHOSPHORIC ACID; THUJA OCCIDENTALIS LEAF; .ALPHA.-TOCOPHEROL 3; 3; 3; 3; 6; 12; 6; 30; 200; 200; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 43853-0010_62d55133-8273-4fb3-aa24-da5303c05c35 43853-0010 HUMAN OTC DRUG DNA RNA Arnica montana, Avena sativa, Damiana, DNA, Korean Ginseng, Oleum animale, Pituitaria glandula (bovine), RNA, Thuja occidentalis, SPRAY ORAL 20140505 20201222 UNAPPROVED HOMEOPATHIC ProBLEN ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; ASIAN GINSENG; CERVUS ELAPHUS HORN OIL; BOS TAURUS PITUITARY GLAND; SACCHAROMYCES CEREVISIAE RNA; THUJA OCCIDENTALIS LEAFY TWIG 6; 3; 3; 9; 3; 6; 5; 9; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43853-0012_236b7710-b776-469f-b48a-c48c4e542160 43853-0012 HUMAN OTC DRUG HGH Plus Arnica Montana, Deer Antler Velvet, Hepar Bovine, HGH, Hypophysis Suis, IGF-1, Thuja Occidentalis SPRAY ORAL 20160901 UNAPPROVED HOMEOPATHIC ProBLEN ARNICA MONTANA; CERVUS ELAPHUS VELVET; BEEF LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND; LONG-(ARG3)INSULIN-LIKE GROWTH FACTOR-I; THUJA OCCIDENTALIS LEAFY TWIG 6; 8; 6; 24; 5; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43853-0013_e78878c8-6130-46fe-9812-f0b646416135 43853-0013 HUMAN OTC DRUG HGH Human Growth Hormone (2 Parts), Hypophysis Suis (2 Parts), Hepar Suis (1 Part) SPRAY ORAL 20161123 UNAPPROVED HOMEOPATHIC ProBLEN SOMATROPIN; SUS SCROFA PITUITARY GLAND; PORK LIVER 30; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43853-0014_28033bb9-bd2c-4223-a7e7-b7fd11286091 43853-0014 HUMAN OTC DRUG DNA RNA Arnica Montana, Avena Sativa, Damiana, DNA, Hypophysis Suis, Oleum Animale, Panax Ginseng, RNA, Thuja Occidentalis SPRAY ORAL 20161123 UNAPPROVED HOMEOPATHIC ProBLEN ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; SUS SCROFA PITUITARY GLAND; CERVUS ELAPHUS HORN OIL; ASIAN GINSENG; SACCHAROMYCES CEREVISIAE RNA; THUJA OCCIDENTALIS LEAFY TWIG 6; 3; 3; 9; 5; 6; 3; 9; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43853-0015_a88de64e-3e4d-4d2a-8fd3-4fd97066080e 43853-0015 HUMAN OTC DRUG Air Detox argentum nitricum, arsenicum album, carduus marianus, hepar suis, mercurius corrosivus, plumbum metallicum SPRAY ORAL 20150609 UNAPPROVED HOMEOPATHIC Problen Pharmacy SILVER NITRATE; ARSENIC TRIOXIDE; MILK THISTLE; PORK LIVER; MERCURIC CHLORIDE; LEAD 200; 200; 1; 6; 200; 200 [hp_C]/28g; [hp_C]/28g; [hp_X]/28g; [hp_X]/28g; [hp_C]/28g; [hp_C]/28g E 20171231 43853-0016_6cd46de7-4bb9-43f4-9d3f-37b54a4ff03c 43853-0016 HUMAN OTC DRUG Metals Detox alumina, arsenicum metallicum, mercurius corrosivus, niccolum metallicum, plumbum metallicum, radium bromatum, stannum metallicum SPRAY ORAL 20150609 UNAPPROVED HOMEOPATHIC Problen Pharmacy ALUMINUM OXIDE; ARSENIC; MERCURIC CHLORIDE; NICKEL; LEAD; RADIUM BROMIDE; TIN 30; 30; 30; 30; 30; 30; 30 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g E 20171231 43853-0017_31103d8c-5ee4-483e-bd45-aac9eda84b68 43853-0017 HUMAN OTC DRUG Estrogen and Progesterone Agnus Castus, Angelica Sinensis, Apis Mellifica, Arnica Montana, Cimicifuga Racemosa, Estradiol, Estriol, Folliculinum, Galium Aparine, Glycyrrhiza Glabra, Korean Ginseng, Oophorinum (Suis), Progesterone, Sepia, Thuja Occidentalis, Viscum Album SPRAY ORAL 20170112 UNAPPROVED HOMEOPATHIC ProBLEN CHASTE TREE; ANGELICA SINENSIS ROOT; APIS MELLIFERA; ARNICA MONTANA; BLACK COHOSH; ESTRADIOL; ESTRIOL; ESTRONE; GALIUM APARINE; GLYCYRRHIZA GLABRA; ASIAN GINSENG; SUS SCROFA OVARY; PROGESTERONE; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 3; 3; 6; 6; 3; 9; 9; 9; 3; 3; 3; 30; 6; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43853-0018_257f463d-ce4d-4294-8599-d3526536543e 43853-0018 HUMAN PRESCRIPTION DRUG Estrogen and Progesterone Agnus Castus, Angelica Sin, Apis Mel, Cimicifuga Rac, Estradiol, Estriol, Folliculinum, Galium, Glycyrrhiza, Oophorinum, Progesterone, Sepia. LIQUID ORAL 20170509 UNAPPROVED HOMEOPATHIC ProBlen CHASTE TREE; ANGELICA SINENSIS ROOT; APIS MELLIFERA; BLACK COHOSH; ESTRADIOL; ESTRIOL; ESTRONE; GALIUM APARINE; GLYCYRRHIZA GLABRA; SUS SCROFA OVARY; PROGESTERONE; SEPIA OFFICINALIS JUICE 3; 3; 6; 3; 9; 9; 9; 3; 3; 30; 6; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 43853-0019_1af2e7d6-a690-4ecc-8eeb-b8aaf2d3f31d 43853-0019 HUMAN OTC DRUG Libido Damiana, Galium, Glandula Suprarenalis, Hepar, Hypophysis, Korean Ginseng, Nuphar, Orchitinum, Phosphoricum ac, Populus Trem, Testosterone. LIQUID ORAL 20170509 UNAPPROVED HOMEOPATHIC ProBlen TURNERA DIFFUSA LEAFY TWIG; GALIUM APARINE; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; ASIAN GINSENG; NUPHAR LUTEA ROOT; SUS SCROFA TESTICLE; PHOSPHORIC ACID; POPULUS TREMULOIDES WHOLE; TESTOSTERONE 3; 3; 12; 6; 12; 1; 2; 6; 200; 3; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 43853-0020_d50adc84-9442-4016-a4ec-fb9339dcfee4 43853-0020 HUMAN OTC DRUG Adrenal and DHEA Aralia Quinquefolia, Ashwagandha, Avena Sativa, Carduus Marianus, Dhea, Glandula Suprarenalis Suis, L-Arginine, Natrum Muriaticum, Phosphoricum Acidum, Rhodiola. LIQUID ORAL 20170509 UNAPPROVED HOMEOPATHIC ProBLEN AMERICAN GINSENG; WITHANIA SOMNIFERA ROOT; AVENA SATIVA FLOWERING TOP; MILK THISTLE; PRASTERONE; SUS SCROFA ADRENAL GLAND; ARGININE; SODIUM CHLORIDE; PHOSPHORIC ACID; RHODIOLA KIRILOWII ROOT 3; 3; 3; 3; 6; 12; 6; 30; 200; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL N 20181231 43853-0021_04d6fe62-d706-4e43-9c0b-00a301be1d18 43853-0021 HUMAN OTC DRUG Testosterone Avena Sativa, Baryta Carbonica, Carduus Mar, Damiana, Hamamelis Virg, Hepar, Korean Ginseng, Nuphar, Orchitinum, Phosphoricum Acidum, Populus Trem, Sabal Serulata, Selenium Metallicum, Testosterone. LIQUID ORAL 20170628 UNAPPROVED HOMEOPATHIC ProBlen AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; MILK THISTLE; TURNERA DIFFUSA LEAFY TWIG; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; ASIAN GINSENG; NUPHAR LUTEA ROOT; SUS SCROFA TESTICLE; PHOSPHORIC ACID; POPULUS TREMULOIDES LEAF; SAW PALMETTO; SELENIUM; TESTOSTERONE 1; 8; 1; 1; 1; 6; 1; 2; 6; 12; 1; 6; 12; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 43853-0022_986b1d39-df27-4a0d-98d9-117151f2717e 43853-0022 HUMAN PRESCRIPTION DRUG HGH Plus IGF 1 and IGF 2 Alpha - GPC, Deer Antler Velvet, Hepar Suis (Liver Extract), HGH, IGF-1, IGF-2, Pituitarum Post. LIQUID ORAL 20171120 UNAPPROVED HOMEOPATHIC ProBlen CHOLINE ALFOSCERATE; CERVUS ELAPHUS VELVET; PORK LIVER; SOMATROPIN; LONG-(ARG3)INSULIN-LIKE GROWTH FACTOR-I; INSULIN-LIKE GROWTH FACTOR-2; SUS SCROFA PITUITARY GLAND, POSTERIOR 8; 6; 6; 12; 12; 12; 5 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] N 20181231 43853-0100_0bfb290c-c201-456e-8b7b-01a69d102426 43853-0100 HUMAN PRESCRIPTION DRUG HGH Plus Arnica Montana, Deer Antler Velvet, Hepar Bovine, HGH, IGF-1, Pituitaria Glandula Bovine, Thuja Occidentalis, SPRAY ORAL 20140121 20210228 UNAPPROVED HOMEOPATHIC ProBLEN ARNICA MONTANA; CERVUS ELAPHUS VELVET; BEEF LIVER; SOMATROPIN; MECASERMIN; BOS TAURUS PITUITARY GLAND; THUJA OCCIDENTALIS LEAF 6; 8; 6; 24; 8; 5; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] N 20181231 43857-0001_cb2bdc15-3f93-45c9-9807-ebae2dc8ab08 43857-0001 HUMAN OTC DRUG Ligatone Arnica Montana, Bryonia, Calcarea Phosphorica, Causticum, Kali Carbonicum, Manganese Gluconate, Mezereum, Rhus Tox, Ruta Graveolens, Silicea LIQUID ORAL 20120413 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; BRYONIA ALBA ROOT; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; POTASSIUM CARBONATE; MANGANESE GLUCONATE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0002_31e591f4-a797-4f4d-8756-002c58e9c143 43857-0002 HUMAN OTC DRUG Additox Phytolacca Decandra, Trifolium Pratense, Xanthoxylum Fraxineum, Arsenicum Album, Belladonna, Chelidonium Majus, Lycopodium Clavatum, Phosphoricum Acidum, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methylparaben, Propylparaben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum LIQUID ORAL 20130110 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PHYTOLACCA AMERICANA ROOT; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 3; 3; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0003_98a25f9e-70c9-4206-b025-acb9a3d9c9cb 43857-0003 HUMAN OTC DRUG Evtox Cochlearia Officinalis, Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Tabebuia Imipetiginosa, Propolis, Glandula Suprarenalis Suis, Thynus (suis), Aranea Diadema, Ipecacuanha, Lycopodium Clavatum, Muriaticum acidum, Nitricum Acidum, Rhus Toxicodendron, Silicea, Epstein Barr Virus, LIQUID ORAL 20130111 20190227 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. COCHLEARIA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; ARANEUS DIADEMATUS; IPECAC; LYCOPODIUM CLAVATUM SPORE; HYDROCHLORIC ACID; NITRIC ACID; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; HUMAN HERPESVIRUS 4 3; 3; 3; 3; 3; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0004_7eb6e38e-1f09-405b-a364-c6c0ce032ecb 43857-0004 HUMAN OTC DRUG Inflammation II Astragalus Membranaceus, Echinacea (Angustifolia), Hydrastis Canadensis, Sarsaparilla, Tabebuia Impetiginosa, Thyroidinum (Suis), Aurum Metallicum, Carbo Animalis, Causticum, Natrum Sulphuricum, Gelsemium Sempervirens, Phosphorus, Sulphur, Thuja Occidentalis LIQUID ORAL 20130111 20200806 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ASTRAGALUS PROPINQUUS ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; SMILAX REGELII ROOT; TABEBUIA IMPETIGINOSA BARK; SUS SCROFA THYROID; GOLD; CARBO ANIMALIS; CAUSTICUM; SODIUM SULFATE; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 3; 8; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0005_47be3c2b-9ae4-4eb5-9c5c-89bdd9289c58 43857-0005 HUMAN OTC DRUG Metalogin Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Stillingia Sylvatica, Trifolium Pratense, Methionine, Thyroidinum (suis), Selenium Dioxide, Lycopodium Clavatum, Nux Vomica, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Berylium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium Metallicum, Cobaltum Metallicum, LIQUID ORAL 20130111 20190728 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. GARLIC; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; METHIONINE; SUS SCROFA THYROID; SELENIUM DIOXIDE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; IRIDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0006_a9d1fa70-ef22-4ffb-b7d5-cdb307ae0439 43857-0006 HUMAN OTC DRUG Pituitary Forte Hypophysis Suis, Hypothalamus (Suis), Pineal (Suis) SPRAY ORAL 20120417 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0007_ffa646bc-eed3-48c2-878a-ba72b680cc2c 43857-0007 HUMAN OTC DRUG Pollen Mix Alfalfa, American Elm, Sycamore, Ash, Beech, Black Walnut, Black Willow, Box Elder, Eastern Cottonwood, False Ragweed, Giant Ragweed, Goldenrod, Kentucky Bluegrass, Orchard Grass, Red Birch, Red Clover, Red Oak, Redtop Grass, Hickory, Sheep Sorrel, Short Ragweed, Timothy Grass, Western Ragweed, Yellow Dock LIQUID ORAL 20130114 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALFALFA; ULMUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA TRIFIDA POLLEN; SOLIDAGO VIRGAUREA FLOWERING TOP; POA PRATENSIS TOP; DACTYLIS GLOMERATA TOP; BETULA OCCIDENTALIS POLLEN; TRIFOLIUM PRATENSE FLOWER; QUERCUS RUBRA POLLEN; AGROSTIS GIGANTEA TOP; CARYA OVATA POLLEN; RUMEX ACETOSELLA POLLEN; AMBROSIA ARTEMISIIFOLIA; PHLEUM PRATENSE TOP; AMBROSIA PSILOSTACHYA TOP; RUMEX CRISPUS TOP 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0008_bd55489c-730b-4a09-b00d-87c34644f831 43857-0008 HUMAN OTC DRUG Serotonin Serotonin LIQUID ORAL 20121008 20180219 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SEROTONIN 6 [hp_X]/mL N 20181231 43857-0009_ba6a08d1-24b5-4f10-8167-39c421e8362e 43857-0009 HUMAN OTC DRUG Systemic Detox Berberis Vulgaris, Boldo, Chelidonium Majus, Hydrastis Canadensis, Lappa Major, Taraxacum Officinale, Trifolium Pratense, Condurango, Ginkgo Biloba, Tabebuia Impetiginosa, Conium Maculatum, Hepar Sulphuris Calcareum, Lycopodium Clavatum, Sarsaparilla, Aloe Socotrina, Echinacea, Natrum Sulphuricum, Nux Vomica, Thuja Occidentalis LIQUID ORAL 20130116 20181216 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; GOLDENSEAL; ARCTIUM LAPPA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; MARSDENIA CONDURANGO BARK; GINKGO; TABEBUIA IMPETIGINOSA BARK; CONIUM MACULATUM FLOWERING TOP; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; SMILAX REGELII ROOT; ALOE; ECHINACEA, UNSPECIFIED; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 3; 3; 3; 6; 6; 6; 12; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0010_33bc9bbd-68e3-461a-a96d-ce9773d8baf9 43857-0010 HUMAN OTC DRUG Thyrotox Chondrus Crispus, Fucus Vesiculosus, Thyroidinum, Belladonna, Calcarea Carbonica, Conium Maculatum, Iodium, Kali Carbonicum, Phosphorus, Pulsatilla (Vulgaris), Silicea LIQUID ORAL 20130116 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHONDRUS CRISPUS; FUCUS VESICULOSUS; SUS SCROFA THYROID; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; IODINE; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE 3; 3; 8; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0011_ce0e1b6a-2302-4585-9492-42162bb8727d 43857-0011 HUMAN OTC DRUG Candida Combo Candida Albicans LIQUID ORAL 20130116 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 12 [hp_X]/mL N 20181231 43857-0012_10fed5ff-dce0-4d62-b6b4-11d06f5c33cd 43857-0012 HUMAN OTC DRUG Sciatica HP Aconitum Napellus, Aesculus Hippocastanum, Colchicum Autumnale, Hypericum Perforatum, Magnesia Phosphorica, Plumbum Metallicum, Rhus Tox, Arnica Montana LIQUID ORAL 20130117 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACONITUM NAPELLUS; HORSE CHESTNUT; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; LEAD; TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0013_c9fa8d80-0ffa-45b5-8bd7-d1042257c9a7 43857-0013 HUMAN OTC DRUG Hepatatox Triticum Aestivum, Chelidonium Majus, Taraxacum Officinale, Glutathione, Hepar Suis, Thyroidinum (suis), Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Aceticum Acidum, Adrenocorticotrophin, Benzoicum Acidum, Benzyl Alcohol, Boricum Acidum, Chlorinum, Cortisone Aceticum, Eugenol, Folliculinum, Isopropyl Palmitate, Lacticum Acidum, Petroleum Jelly, Phenylbutazone, Plumbum Metallicum, Potassium Sorbate, Resorcinol, Salicylieum Acidum, Sorbitol, Steary Alcohol, Xylitol, LIQUID ORAL 20130117 20190519 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRITICUM AESTIVUM WHOLE; CHELIDONIUM MAJUS; TARAXACUM OFFICINALE; GLUTATHIONE; PORK LIVER; SUS SCROFA THYROID; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; ACETIC ACID; CORTICOTROPIN; BENZOIC ACID; BENZYL ALCOHOL; BORIC ACID; CHLORINE; CORTISONE ACETATE; EUGENOL; ESTRONE; ISOPROPYL PALMITATE; LACTIC ACID, DL-; PETROLATUM; PHENYLBUTAZONE; LEAD; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SORBITOL; STEARYL ALCOHOL; XYLITOL 1; 3; 3; 6; 8; 8; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0015_eb502426-6443-4636-9fc5-671ee04e577e 43857-0015 HUMAN OTC DRUG Drainage Echinacea, Phytolacca Decandra, Trifolium Pratense, Calcarea Iodata, Kali Muriaticum, Nitricum Acidum, Phosphoricum Acidum, Sulphur Iodatum LIQUID ORAL 20130117 20181218 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA, UNSPECIFIED; PHYTOLACCA AMERICANA ROOT; TRIFOLIUM PRATENSE FLOWER; CALCIUM IODIDE; POTASSIUM CHLORIDE; NITRIC ACID; PHOSPHORIC ACID; SULFUR IODIDE 3; 3; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0016_8bfb5cc1-e84c-4f74-9120-293b14e19fae 43857-0016 HUMAN OTC DRUG Allerforce Chondrus Crispus, Glycyrrhiza Glabra, Sarsaparilla, Zingiber Officinale, Adrenalinum, Allium Cepa, Aralia Racemosa, Arsenicum Album, Calcarea Carbonica, Cantharis, Iodium, Natrum Carbonicum, Rhus Tox, LIQUID ORAL 20130219 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHONDRUS CRISPUS; GLYCYRRHIZA GLABRA; SMILAX REGELII ROOT; GINGER; EPINEPHRINE; ONION; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYTTA VESICATORIA; IODINE; SODIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 3; 8; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0017_eede9418-7a22-459e-aab8-3e8e673fa0db 43857-0017 HUMAN OTC DRUG Injury Topical Calendula Officinalis, Arnica Montana, Symphytum Officinale, Hypericum Perforatum, Bellis Perennis, Carbo Vegetabilis, Hamamelis Virginiana, Millefolium, Rhus Tox, Ruta Graveolens, Veratrum Album, LOTION TOPICAL 20130218 20201201 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; COMFREY ROOT; HYPERICUM PERFORATUM; BELLIS PERENNIS; ACTIVATED CHARCOAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACHILLEA MILLEFOLIUM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; VERATRUM ALBUM ROOT 1; 1; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43857-0018_d106fb81-4f10-48dc-95e4-d067fe2e259c 43857-0018 HUMAN OTC DRUG Lym D Chelidonium Majus, Echinacea, Hydrastis Canadensis, Nasturtium Aquaticum, Taraxacum Officinale, Trifolium Pratense, Urtica Dioica, Thymus (suis), Thyroidinum (suis), Arsenicum Album, Coccus Cacti, Lycopodium Clavatum, Phosphorus, Rhus Toxicodendron, Lym D Nosode, Ledum Palustre LIQUID ORAL 20130222 20190102 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; NASTURTIUM OFFICINALE; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA; SUS SCROFA THYMUS; SUS SCROFA THYROID; ARSENIC TRIOXIDE; PROTORTONIA CACTI; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; BORRELIA BURGDORFERI; LEDUM PALUSTRE TWIG 3; 3; 3; 3; 3; 3; 3; 8; 8; 12; 12; 12; 12; 12; 12; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0019_70286606-47dd-4948-b533-7e7f984b6a81 43857-0019 HUMAN OTC DRUG Dopamine Dopamine, LIQUID ORAL 20120501 20180521 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. DOPAMINE 6 [hp_X]/mL N 20181231 43857-0020_ed2e7ff3-6bb3-4cfc-9c6b-26b5e3bd60cd 43857-0020 HUMAN OTC DRUG Melatonin Forte Melatonin, Nadidum, Niacin, Pyridoxinum Hydrochloricum, Zincum Sulphuricum, Hypophysis Suis, Hypothalamus (Suis), Lithium Carbonicum, Magnesia Carbonica, Pineal (Suis) SPRAY ORAL 20120504 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MELATONIN; NADIDE; NIACIN; PYRIDOXINE HYDROCHLORIDE; ZINC SULFATE HEPTAHYDRATE; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; LITHIUM CARBONATE; MAGNESIUM CARBONATE; SUS SCROFA PINEAL GLAND 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0022_1c94121d-ca1a-472c-a0ea-1191ff266179 43857-0022 HUMAN OTC DRUG Natural Testosterone Avena sativa, Epimedium, Lycopodium clavatum, Androstenedione, Damiana, Testosterone, Agnus castus, SPRAY ORAL 20120522 20180828 UNAPPROVED HOMEOPATHIC BioActive Nutritional AVENA SATIVA FLOWERING TOP; EPIMEDIUM GRANDIFLORUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; ANDROSTENEDIONE; TURNERA DIFFUSA LEAFY TWIG; TESTOSTERONE; CHASTE TREE 3; 3; 3; 6; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0023_646399fe-1b7f-4116-a294-409c1a775e16 43857-0023 HUMAN OTC DRUG NADH Plus Nadidum, Adenosinum Cyclophosphoricum, Calcium D-Pantothenate, Cholinum, Riboflavinum, Ubidecarenonum, Dimethyl Glycine SPRAY ORAL 20120531 UNAPPROVED HOMEOPATHIC BioActive Nutritional NADIDE; ADENOSINE CYCLIC PHOSPHATE; CALCIUM PANTOTHENATE; CHOLINE HYDROXIDE; RIBOFLAVIN; UBIDECARENONE; N,N-DIMETHYLGLYCINE 4; 6; 6; 6; 6; 6; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0024_185fef23-9800-4a6f-bc5d-11f4b747c102 43857-0024 HUMAN OTC DRUG Endocrine Balancer Fucus Vesiculosus, Glycyrrhiza Glabra, Sarsaparilla, Glandula Suprarenalis Suis, Pinus Sylvestris, Thyroidinum (Suis), Iodium LIQUID ORAL 20120514 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; SMILAX REGELII ROOT; SUS SCROFA ADRENAL GLAND; PINUS SYLVESTRIS LEAFY TWIG; THYROID, PORCINE; IODINE 3; 3; 3; 6; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0025_e6de2eb6-d157-4984-82ef-9f0e248e5b87 43857-0025 HUMAN OTC DRUG Hemoforce Urtica Urens, Ferrum Muriaticum, Aranea Diadema, Aurum Metallicum, Cinchona Officinalis, Cobaltum Gluconate, Phosphorus LIQUID ORAL 20130121 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. URTICA URENS; FERRIC CHLORIDE HEXAHYDRATE; ARANEUS DIADEMATUS; GOLD; CINCHONA OFFICINALIS BARK; COBALTOUS GLUCONATE; PHOSPHORUS 3; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0026_9159c6fe-2ffe-45a7-92aa-7158590ccd52 43857-0026 HUMAN OTC DRUG Thyro Tonic Chelidonium majus, Spongia tosta, Lac defloratum, Fucus vesiculosus, Hepar suis, Pituitary (suis), Thyroidinum (suis), Calcarea carbonica, Ferrum iodatum, Iodium, Kali iodatum, Molybdenum metallicum, Pulsatilla, LIQUID ORAL 20120514 20190827 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; SPONGIA OFFICINALIS SKELETON, ROASTED; SKIM MILK; FUCUS VESICULOSUS; PORK LIVER; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; IODINE; POTASSIUM IODIDE; MOLYBDENUM; PULSATILLA VULGARIS 3; 3; 4; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0027_22cb02d7-49cc-4f20-b26d-0e18d15e9ab6 43857-0027 HUMAN OTC DRUG Geopathic Stress Alfalfa, Avena sativa, Fucus vesiculosus, Symphytum officinale, Agate, Calcarea carbonica, Ferrum metallicum, Phosphorus, Quartz, Silicea, Cuprum metallicum, Tarentula hispana, LIQUID ORAL 20120514 20201106 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; FUCUS VESICULOSUS; COMFREY ROOT; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IRON; PHOSPHORUS; COPPER; LYCOSA TARANTULA; ALCOHOL, X-RAY EXPOSED (1000 RAD) 3; 3; 3; 3; 12; 12; 12; 12; 30; 30; 40 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0028_3e8de4d5-4dd3-44d5-b228-feebc2de9f7c 43857-0028 HUMAN OTC DRUG Immuno Fortifier Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Osha, Tabebuia Impetiginosa, Trigonella Foenum-Graecum, Ascorbic Acid, Pinus Sylvestris, Lymph (suis), Medulla Ossis (suis), Spleen (suis), Thymus (suis), Hepar sulphuris calcareum, Phosphoricum acidum, Silicea LIQUID ORAL 20120820 20180318 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc ECHINACEA, UNSPECIFIED; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; LIGUSTICUM PORTERI ROOT; TABEBUIA IMPETIGINOSA BARK; FENUGREEK SEED; ASCORBIC ACID; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; CALCIUM SULFIDE; PHOSPHORIC ACID; SILICON DIOXIDE 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 43857-0029_47ab5840-d52f-46f3-a62e-bf4095ceb42c 43857-0029 HUMAN OTC DRUG Calciforce Arnica Montana, Chamomilla, Echinacea (Angustifolia), Symphytum Officinale, Boron Gluconate, Calcarea Fluorica, Calcarea Phosphorica, Hekla Lava, Lycopodium Clavatum, Silicea, Calcarea Carbonica LIQUID ORAL 20130130 20210517 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; COMFREY ROOT; BORON GLUCONATE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; HEKLA LAVA; LYCOPODIUM CLAVATUM SPORE; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0030_1e63f100-134c-4e48-b8c6-045c2851cac6 43857-0030 HUMAN OTC DRUG CVTox Cochlearia armoracia, Echinacea, Hydrastis canadensis, Lomatium dissectum, Tabebuia impetiginosa, Propolis, Glandula suprarenalis bovinum, Thymus gland (suis), Aranea diadema, Ipecacuanha, Lycopodium clavatum, Muriaticum acidum, Nitricum acidum, Phosphoricum acidum, Rhus toxicodendron, Silicea, Cytomegalovirus, Epstein-barr virus, Herpes zoster, Morbillinum, Piliomyelitis, Hepatitis B, Coxsackie B1, Coxsackie B4, LIQUID ORAL 20120522 20180820 UNAPPROVED HOMEOPATHIC BioActive Nutritional HORSERADISH; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; TABEBUIA IMPETIGINOSA WHOLE; PROPOLIS WAX; BOS TAURUS ADRENAL GLAND; SUS SCROFA THYMUS; ARANEUS DIADEMATUS; IPECAC; LYCOPODIUM CLAVATUM SPORE; HYDROCHLORIC ACID; NITRIC ACID; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 3; MEASLES VIRUS; POLIOVIRUS; HEPATITIS B VIRUS; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4 3; 3; 3; 3; 3; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 33; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0031_87fac1e0-341b-4b57-bf3f-881f7732e9bf 43857-0031 HUMAN OTC DRUG Hypopituitaryplex Aralia Quinquefolia, Hydrocotyle Asiatica, Polygonum Multiflorum, Hypophysis Suis, Hypothalamus (Suis), Germanium Sesquioxide, Pineal Gland (Suis) LIQUID ORAL 20130121 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; CENTELLA ASIATICA; FALLOPIA MULTIFLORA ROOT; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; GERMANIUM SESQUIOXIDE; SUS SCROFA PINEAL GLAND 3; 3; 3; 8; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0032_870e8e62-178d-46f7-949c-44edb95794e2 43857-0032 HUMAN OTC DRUG Asthmaforce Arnica montana, Asclepias tuberosa, Eriodictyon californicum, Eucalyptus globulus, Lobelia inflata, Plantago major, Trifolium pratense, Arsenicum album, Belladonna, Bryonia, Carbo vegetabilis, Grindelia, Kali carbonicum, Natrum sulphuricum, Pulsatilla, LIQUID ORAL 20120601 UNAPPROVED HOMEOPATHIC BioActive Nutritional ARNICA MONTANA; ASCLEPIAS TUBEROSA ROOT; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; LOBELIA INFLATA; PLANTAGO MAJOR; TRIFOLIUM PRATENSE FLOWER; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; GRINDELIA HIRSUTULA FLOWERING TOP; POTASSIUM CARBONATE; SODIUM SULFATE; PULSATILLA VULGARIS 3; 3; 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0033_5b0e32b7-7674-473b-a5f2-5693a58d75f0 43857-0033 HUMAN OTC DRUG Gynobalance Dehydroepiandrosterone, Estradiol, Pregnenolone, Progesterone, Testosterone LIQUID ORAL 20130118 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PRASTERONE; ESTRADIOL; PREGNENOLONE; PROGESTERONE; TESTOSTERONE 6; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0034_5335f231-9d84-43b4-9320-4f3622964fb2 43857-0034 HUMAN OTC DRUG Otoflam HP Belladonna, Conium Maculatum, Dulcamara, Hepar Sulphuris Calcareum, Kali Bichromicum, Mercurius Solubilis, Pulsatilla (Vulgaris), Silicea, Chamomilla LIQUID ORAL 20120713 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; CALCIUM SULFIDE; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SILICON DIOXIDE; MATRICARIA RECUTITA 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0036_1f0470c6-3593-4150-8b40-ed71f0d4b6f4 43857-0036 HUMAN OTC DRUG Tri Estrogen Folliculinum, Oophorinum, SPRAY ORAL 20120601 UNAPPROVED HOMEOPATHIC BioActive Nutritional ESTRONE; SUS SCROFA OVARY 6; 6 [hp_X]/mL; [hp_X]/mL N 20181231 43857-0037_7dccd1d9-3940-43a1-81b2-3e5f6ff11d68 43857-0037 HUMAN OTC DRUG Thyroid HP Baryta Carbonica, Calcarea Carbonica, Fucus Vesiculosus, Iodium, Natrum Muriaticum, Pulsatilla, Spongia Tosta, Thyroidinum (Suis) LIQUID ORAL 20130124 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FUCUS VESICULOSUS; IODINE; SODIUM CHLORIDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0039_e4462f59-9ba5-43a9-9b2b-3e5a807545dd 43857-0039 HUMAN OTC DRUG Dentox Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Lymph Node(Suis), Medulla Ossis Suis, Thymus (Suis), Thyroidinum (Suis), LIQUID ORAL 20120605 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA THYMUS; THYROID, PORCINE; CALCIUM FLUORIDE; SODIUM FLUORIDE; SILVER; GOLD; COPPER; EUGENOL; FORMALDEHYDE; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; TIN; TITANIUM; ZINC 3; 3; 3; 3; 3; 3; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0040_ba8d47ad-23d2-4dc4-bb59-948db1f18aec 43857-0040 HUMAN OTC DRUG Envirotox Triticum Aestivum, Berberis Vulgaris, Lappa Major, Phytolacca Decandra, Rhamnus Cathartica, Rhamnus Purshiana, Glycyrrhiza Glabra, Stillingia Sylvatica, Trifolium Pratense, Xanthoxylum Fraxineum, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina LIQUID ORAL 20130123 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRITICUM AESTIVUM WHOLE; BERBERIS VULGARIS ROOT BARK; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; RHAMNUS CATHARTICA FRUIT; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ACETONE; SODIUM TRIPOLYPHOSPHATE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; AMMONIUM CHLORIDE; SODIUM LAURYL SULFATE; TURPENTINE OIL; ATROPA BELLADONNA WHOLE; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 1; 3; 3; 3; 3; 3; 6; 6; 6; 6; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0041_8307ff37-f16d-4890-9a51-95b4dd25af16 43857-0041 HUMAN OTC DRUG ANX HP Arsenicum Album, Calcarea Carbonica, Ignatia Amara, Kali Carbonicum, Lachesis Mutus, Natrum Muriaticum LIQUID ORAL 20130124 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0042_491683ed-4fcf-49aa-9c72-8e97e95d0f62 43857-0042 HUMAN OTC DRUG Sinuchron HP Arsenicum Album, Hepar Sulphuris Calcareum, Kali Bichromicum, Lycopodium Clavatum, Mercurius Solubilis, Natrum Muriaticum, Phosphorus, Pulsatilla (Vulgaris), Sepia LIQUID ORAL 20130125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0044_3b2172e5-f0de-4c46-a8eb-e1074c763e0c 43857-0044 HUMAN OTC DRUG Sinuforce Echinacea, Hydrastis Candensis, Nux Moschata, Trigonella Foenum Graecum, Arsenicum Album, Kali Bichromicum, Mercurius Sulphuratus Ruber, Pulsatilla, Sepia, Mercurius Solubilis, LIQUID ORAL 20130124 20190114 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA, UNSPECIFIED; GOLDENSEAL; NUTMEG; FENUGREEK SEED; ARSENIC TRIOXIDE; POTASSIUM DICHROMATE; MERCURIC SULFIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; MERCURIUS SOLUBILIS 3; 3; 3; 3; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0045_4bbbfc7d-afbe-4e41-a18d-5028cec3dfc6 43857-0045 HUMAN OTC DRUG LGB HP Belladonna, Chelidonium Majus, Colocynthis, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris), Veratrum Album LIQUID ORAL 20130123 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA WHOLE; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0046_ef0b8492-1f6d-4cd6-b9df-33ab97366b29 43857-0046 HUMAN OTC DRUG Mold Mix Antigens Arsenicum Album, Phosphorus, Pulsatilla, Sepia, Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Pullularia Pullulans, Rhizopus Nigricans, Torula Cerevisiae LIQUID ORAL 20130211 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0047_70cc3133-9618-4046-9419-59557b034fe4 43857-0047 HUMAN OTC DRUG Chlorogenic Acid Chlorogenic acid, LIQUID ORAL 20120626 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHLOROGENIC ACID 6 [hp_X]/mL N 20181231 43857-0048_4f0bc102-35ff-48b4-a92f-87c1cd0881d8 43857-0048 HUMAN OTC DRUG Diabenex HP Colchicum Autumnale, Lacticum Acidum, Lycopodium Clavatum, Phosphoricum Acidum, Phosphorus, Syzygium Jambolanum, Uranium Nitricum LIQUID ORAL 20130118 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. COLCHICUM AUTUMNALE BULB; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0049_71ef9308-bf2e-4d6a-94ee-098eec15738f 43857-0049 HUMAN OTC DRUG Chemtox Triticum Aestivum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Rhamnus Purshiana, Stillingia Sylvatica, Trifolium Pratense, Xanthoxylum Fraxineum, Glandula Suprarenalis Suis, Hepar Suis, Lymph (suis), Thyroidinum (suis), Belladonna, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Salicylicum Acidum, Adrenocorticotrophin, Cortisone Aceticum, Eugenol, Stearyl Alcohol, Xylitol, Folliculinum, Benzoicum Acidum LIQUID ORAL 20130125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRITICUM AESTIVUM WHOLE; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA LYMPH; SUS SCROFA THYROID; ATROPA BELLADONNA WHOLE; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SALICYLIC ACID; CORTICOTROPIN; CORTISONE ACETATE; EUGENOL; STEARYL ALCOHOL; XYLITOL; ESTRONE; BENZOIC ACID; CHLORINE; POTASSIUM SORBATE; SORBITOL; RESORCINOL; BENZYL ALCOHOL; LACTIC ACID, DL-; ISOPROPYL PALMITATE; BORIC ACID; ACETIC ACID; PHENYLBUTAZONE; PETROLATUM; LEAD 1; 3; 3; 3; 3; 3; 3; 3; 3; 3; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0050_a152a313-dc54-4573-98ed-21a9b1ff6d66 43857-0050 HUMAN OTC DRUG Headache Melilotus officinalis, Spigelia anthelmia, Allium cepa, Belladonna, Bryonia, Cimicifuga racemosa, Gelsemium Sempervirens, Glonoinum LIQUID ORAL 20120718 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MELILOTUS OFFICINALIS TOP; SPIGELIA ANTHELMIA; ONION; ATROPA BELLADONNA ROOT; BRYONIA ALBA ROOT; BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS WHOLE; SILICON DIOXIDE; CITHARACANTHUS SPINICRUS 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0051_772840c6-bef7-4678-91e2-5f5b468d2653 43857-0051 HUMAN OTC DRUG V HP Arsenicum Album, Belladonna, Echinacea, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lycopodium Clavatum, Phosphoricum Acidum, Phosphorus, Pyrogenium, Rhus Toxicodendron LIQUID ORAL 20130125 20181226 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0052_28085bf7-1bc3-411c-b0b1-759669dc94ca 43857-0052 HUMAN OTC DRUG DHEA Forte Dehydroepiandrosterone (DHEA), Pregnenolone, Progesterone, LIQUID ORAL 20120807 UNAPPROVED HOMEOPATHIC BioActive Nutritionals, Inc. PRASTERONE; PREGNENOLONE; PROGESTERONE 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0053_c7376e69-e05f-4aac-9d41-061389834550 43857-0053 HUMAN OTC DRUG Lym D HP Arsenicum Album, Chelidonium Majus, Coccus Cacti, Echinacea, Hydrastis Canadensis, Lycopodium Clavatum, Lym D Nosode LIQUID ORAL 20130129 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; CHELIDONIUM MAJUS; PROTORTONIA CACTI; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; BORRELIA BURGDORFERI; NASTURTIUM OFFICINALE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; TARAXACUM OFFICINALE; THYMUS SERPYLLUM; SUS SCROFA THYROID; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0055_4faa5f2c-472d-4ea3-aae1-2f000ca5cdb6 43857-0055 HUMAN OTC DRUG Lymph II Echinacea, Phytolacca Decandra, Collinsonia Canadensis, Kali Iodatum, Pinus Sylvestris, Pix Liquida, Ferrum Phosphoricum, Aesculus Hippocastanum, Baryta Carbonica, Berberis Vulgaris, Bufo Rana, Calcarea Carbonica, Calcarea Phosphorica, Causticum, Hepar Sulphuris Calcareum, Kreosotum, Lycopodium Clavatum, Mercurius Solubilis, Natrum Muriaticum, Nitricum Acidum, Phosphorus, Pulsatilla, Silicea, Stellaria Media, Sulphur, Terebinthina, Thuja Occidentalis LIQUID ORAL 20130129 20190319 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA, UNSPECIFIED; PHYTOLACCA AMERICANA ROOT; COLLINSONIA CANADENSIS ROOT; POTASSIUM IODIDE; PINUS SYLVESTRIS LEAFY TWIG; PINE TAR; FERROSOFERRIC PHOSPHATE; HORSE CHESTNUT; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BUFO BUFO CUTANEOUS GLAND; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; CALCIUM SULFIDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE; STELLARIA MEDIA; SULFUR; TURPENTINE OIL; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0056_216b4182-9a8d-4982-8b2c-79d9f14747e7 43857-0056 HUMAN OTC DRUG Liver Tonic II Boldo, Carduus Marianus, Curcuma Longa, Echinacea, Taraxacum Officinale, Magnesia Phosphorica, Gallbladder (bovine), Hepar Bovine, Ammi Visnaga, Atropinum Sulphuricum, Chelidonium Majus, Leptandra Virginica, Podophyllinum, LIQUID ORAL 20120817 20190618 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PEUMUS BOLDUS LEAF; SILYBUM MARIANUM SEED; TURMERIC; ECHINACEA, UNSPECIFIED; TARAXACUM OFFICINALE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; BOS TAURUS GALLBLADDER; BEEF LIVER; AMMI VISNAGA FRUIT; ATROPINE SULFATE; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; PODOPHYLLUM 1; 1; 1; 1; 1; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0057_efc2a916-32ab-4e1b-8575-131f6c9ea685 43857-0057 HUMAN OTC DRUG Adrenal Tonic Aralia Quinquefolia, Glycyrrhiza Glabra, Sarsaparilla, Avena Sativa, Glandula Suprarenalis Bovine, Adrenalinum, Arsenicum Album, Kali Phosphoricum, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Veratrum Album LIQUID ORAL 20160523 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; GLYCYRRHIZA GLABRA; SMILAX REGELII ROOT; AVENA SATIVA FLOWERING TOP; BOS TAURUS ADRENAL GLAND; EPINEPHRINE; ARSENIC TRIOXIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; VERATRUM ALBUM ROOT 1; 1; 1; 3; 8; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0058_2a31540e-3c93-469f-be33-550b9e960425 43857-0058 HUMAN OTC DRUG Allerpoll HP Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Euphrasia Officinalis, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris), Solidago Virgaurea, Sulphur LIQUID ORAL 20120820 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0059_8f76992c-2e03-4369-ad7d-1e34e122b73f 43857-0059 HUMAN OTC DRUG Occuloplex I Euphrasia Officinalis, Ginkgo Biloba, Hydrastis Canadensis, Taraxacum Officinale, Beta Carotene, Cyanocobalamin, Glutathione, Ubiquinone, Zincum Gluconicum, BioFlavonoids, Eye (Bovine), Ammonium Muriaticum , Calcarea Fluorica, Causticum, Conium Maculatum, Germanium Sesquioxide, Magnesia Carbonica, Selenium Dioxide, Silicea LIQUID ORAL 20130125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. EUPHRASIA STRICTA; GINKGO; GOLDENSEAL; TARAXACUM OFFICINALE; .BETA.-CAROTENE; CYANOCOBALAMIN; GLUTATHIONE; UBIDECARENONE; ZINC GLUCONATE; CITRUS BIOFLAVONOIDS; BOS TAURUS EYE; AMMONIUM CHLORIDE; CALCIUM FLUORIDE; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; GERMANIUM SESQUIOXIDE; MAGNESIUM CARBONATE; SELENIUM DIOXIDE; SILICON DIOXIDE 3; 3; 3; 3; 6; 6; 6; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0060_d20c878a-42ff-4965-80d4-07632931fe5a 43857-0060 HUMAN OTC DRUG Menopause Angelica Archangelica, Aralia Quinquefolia, Cimicifuga Racemosa, Hydrastis Canadensis, Pulsatilla, Sabina, Sepia, Sulphuricum Acidum, Lachesis Mutus LIQUID ORAL 20130123 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANGELICA ARCHANGELICA ROOT; AMERICAN GINSENG; BLACK COHOSH; GOLDENSEAL; PULSATILLA VULGARIS; JUNIPERUS SABINA LEAFY TWIG; SEPIA OFFICINALIS JUICE; SULFURIC ACID; LACHESIS MUTA VENOM 3; 3; 3; 3; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0061_33d4f8d9-ca3b-46bb-b0ab-b150f4317872 43857-0061 HUMAN OTC DRUG Pre Post Surgery Hypericum Perforatum, Symphytum Officinale, Arnica Montana LIQUID ORAL 20130124 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HYPERICUM PERFORATUM; COMFREY ROOT; ARNICA MONTANA 12; 12; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0062_f7feedb4-752b-4e75-84d5-29e1a7a92e1c 43857-0062 HUMAN OTC DRUG Scrofularoforce Juniperus Virginiana, Rumex Crispus, Scrophularia Nodosa, Xanthoxylum Fraxineum, Lymph Node, Baryta Carbonica, Baryta Muriatica, Belladonna, Calcarea Carbonica, Conium Maculatum, Helleborus Niger, Iodium, Kali Phosphoricum, Lachesis Mutus, Natrum Phosphoricum, Silicea LIQUID ORAL 20130125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. JUNIPERUS VIRGINIANA TWIG; RUMEX CRISPUS ROOT; SCROPHULARIA NODOSA; ZANTHOXYLUM AMERICANUM BARK; SUS SCROFA LYMPH; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; HELLEBORUS NIGER ROOT; IODINE; POTASSIUM PHOSPHATE, DIBASIC; LACHESIS MUTA VENOM; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE 3; 3; 3; 3; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0063_814e47a3-905b-4c48-840e-e2e5b9e108dd 43857-0063 HUMAN OTC DRUG Hypothalamus HP Aralia Quinquefolia, Germanium Sesquioxide, Hydrocotyle Asiatica, Hypothalamus (Suis), Pineal (Suis), Hypophysis Suis, Polygonum Multiflorum, Carcinosin LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; GERMANIUM SESQUIOXIDE; CENTELLA ASIATICA; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; FALLOPIA MULTIFLORA ROOT; HUMAN BREAST TUMOR CELL 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0064_e4295fdf-883a-4723-8a9e-1b503875b3e8 43857-0064 HUMAN OTC DRUG Cystoges HP Berberis Vulgaris, Cantharis, Clematis Erecta, Lac Caninum, Lycopodium Clavatum, Pulsatilla (Vulgaris), Sarsaparilla, Sepia, Staphysagria LIQUID ORAL 20121026 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. LYTTA VESICATORIA; BERBERIS VULGARIS ROOT BARK; CANIS LUPUS FAMILIARIS MILK; CLEMATIS RECTA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; DELPHINIUM STAPHISAGRIA SEED; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SMILAX REGELII ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0065_2b945bb9-bcab-47a7-ad16-6a871d160bb3 43857-0065 HUMAN OTC DRUG Lymph I Echinacea (Angustifolia), Phytolacca Decandra, Kali Iodatum, Pinus Sylvestris, Hypophysis Suis, Apis Mellifica, Aranea Diadema, Belladonna, Calcarea Carbonica, Clematis Erecta, Conium Maculatum, Galium Aparine, Graphites, Lachesis Mutus, Mercurius Praecipitatus Ruber, Myristica Sebifera, Phosphorus, Rhus Tox, Scrophularia Nodosa, Sulphur, Thyroidinum (Suis), Vespa Crabro LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; POTASSIUM IODIDE; PINUS SYLVESTRIS LEAFY TWIG; SUS SCROFA PITUITARY GLAND; APIS MELLIFERA; ARANEUS DIADEMATUS; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; GALIUM APARINE; GRAPHITE; LACHESIS MUTA VENOM; MERCURIC OXIDE; VIROLA SEBIFERA RESIN; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SCROPHULARIA NODOSA; SULFUR; SUS SCROFA THYROID; VESPA CRABRO 1; 2; 3; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0066_5180c409-72a2-4b6e-acce-be28fd05114f 43857-0066 HUMAN OTC DRUG Thyroplex Fucus Vesiculosus, Spongia Tosta, Iodium, Liothyronine Sodium, Pulsatilla (Vulgaris), Glandula Suprarenalis Suis, Hypophysis (Suis), Thyroidinum (Suis), Calcarea Carbonica, Ferrum Iodatum, Kali Iodatum, Lycopus Virginicus, Phosphoricum Acidum LIQUID ORAL 20120829 UNAPPROVED HOMEOPATHIC BioActive Nutritional FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; IODINE; LIOTHYRONINE SODIUM; PULSATILLA VULGARIS; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; POTASSIUM IODIDE; LYCOPUS VIRGINICUS; PHOSPHORIC ACID 3; 3; 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0067_895c9e1a-0505-4957-8d06-74b07173f470 43857-0067 HUMAN OTC DRUG Quercetin Quercetin LIQUID ORAL 20130124 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. QUERCETIN 6 [hp_X]/mL N 20181231 43857-0068_8c2165d7-6fa8-437d-9d02-62443f8f1e38 43857-0068 HUMAN OTC DRUG Grain and Seed Antigens Barley, Oats, Wheat, Rice, Rye, Millet, Soybean, Corn, Milo, Bamboo, Cotton Seed, Flax seed, Safflower, Sesame, Sunflower, Poppy seed, Sorghum, Sugarcane, Arsenicum album, Lycopodium clavatum, Natrum muriaticum, Sulphur LIQUID ORAL 20130124 20190722 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BARLEY; OAT; WHEAT; BROWN RICE; RYE; MILLET; SOYBEAN; CORN; SORGHUM BICOLOR WHOLE; LOPHATHERUM GRACILE LEAF; COTTON SEED; FLAX SEED; SAFFLOWER; SESAME SEED; SUNFLOWER SEED; POPPY SEED; SORGHUM; SUGARCANE; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SULFUR 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0069_cfbb86f8-bebd-4057-8852-191e111d0199 43857-0069 HUMAN OTC DRUG Hayfever Tonic Echinacea purpurea, Hydrastis canadensis, Eupatorium perfoliatum, Verbascum thapus, Sheep sorrel, Yellow dock, Kentucky Blue grass, Orchard grass, Red Top grass, Timothy grass, LIQUID ORAL 20130222 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA PURPUREA; GOLDENSEAL; EUPATORIUM PERFOLIATUM FLOWERING TOP; VERBASCUM THAPSUS; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; POA PRATENSIS TOP; DACTYLIS GLOMERATA TOP; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIFOLIUM PRATENSE FLOWER; ALFALFA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA TRIFIDA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; CARYA OVATA POLLEN; QUERCUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; AILANTHUS ALTISSIMA FLOWERING TWIG; ONION; AMBROSIA ARTEMISIIFOLIA; GOLD TRICHLORIDE; CAMPHOR (NATURAL); IPECAC; POTASSIUM DICHROMATE 1; 1; 1; 3; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0070_08227eaf-52f4-423c-8fa5-91f2a2e4b489 43857-0070 HUMAN OTC DRUG Arnica Arnica Montana LIQUID ORAL 20121008 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA ROOT 3 [hp_X]/mL N 20181231 43857-0072_94216dd8-bd63-4f09-be56-57198f0a9e76 43857-0072 HUMAN OTC DRUG Cardiotone Adonis vernalis, Strophanthus hispidus, ATP (Adenosine Triphosphate), Cactus grandiflorus, Convallaria Majalis, Kali Gluconicum, Magnesium Gluconicum, Thyroidinum (Suis), Ubiquinone, Cor (suis), Kali Gluconicum, Germainium sesquioxide, Digitalis purpurea, LIQUID ORAL 20120913 20180905 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ADONIS VERNALIS; STROPHANTHUS HISPIDUS SEED; ADENOSINE TRIPHOSPHATE; SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; PORK HEART; POTASSIUM GLUCONATE; MAGNESIUM GLUCONATE; THYROID, PORCINE; UBIDECARENONE; GERMANIUM SESQUIOXIDE; DIGITALIS 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0073_9f11c01e-e753-4231-a254-f66c404597cd 43857-0073 HUMAN OTC DRUG Cardio Tonic Kali Muriaticum, Kali Phosphoricum, Plantago Major, Cactus Grandiflorus, Digitalis Purpurea, Heart (Bovine), L-Carnitine, L-Valine, Thyroidinum (Suis), Abrotanum (Artemisia Abrotanum), Iodium, Lecithin, Spigelia Anthelmia LIQUID ORAL 20130117 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; PLANTAGO MAJOR; SELENICEREUS GRANDIFLORUS STEM; DIGITALIS; BEEF HEART; LEVOCARNITINE; VALINE; SUS SCROFA THYROID; ARTEMISIA ABROTANUM FLOWERING TOP; IODINE; EGG PHOSPHOLIPIDS; SPIGELIA ANTHELMIA 3; 3; 3; 5; 6; 6; 6; 6; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0074_8ccb53ef-d56b-4595-a526-ee755af399ee 43857-0074 HUMAN OTC DRUG Estrogen Folliculinum, Oophorinum LIQUID ORAL 20121008 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ESTRONE; SUS SCROFA OVARY 6; 6 [hp_X]/mL; [hp_X]/mL N 20181231 43857-0075_8659c999-8b66-49df-befb-051e03f2a0a6 43857-0075 HUMAN OTC DRUG Cough HP Arsenicum Album, Bryonia (Alba), Cuprum Aceticum, Drosera (Rotundifolia), Ipecacuanha, Kali Carbonicum, Phosphorus, Pulsatilla (Vulgaris), Spongia Tosta LIQUID ORAL 20130125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0076_3f8eb7c0-bdfc-47a1-bafa-7901372c6a86 43857-0076 HUMAN OTC DRUG Shark Cartilage Shark Cartilage LIQUID ORAL 20121008 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SHARK CARTILAGE 12 [hp_X]/mL N 20181231 43857-0079_eea2967d-3b72-4d27-9b12-e64b67e6f313 43857-0079 HUMAN OTC DRUG Relaxoforce Humulus Lupulus, Passiflora Incarnata, Valeriana Officinalis, Calcarea Carbonica, Coffea Tosta, Ignatia Amara, Kali Phosphoricum, Moschus, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris) LIQUID ORAL 20130123 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HOPS; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COFFEA ARABICA SEED, ROASTED; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0080_d6716903-f06f-470e-9311-08738112a448 43857-0080 HUMAN OTC DRUG Hydrate II Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Performatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea LIQUID ORAL 20130218 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. COFFEA ARABICA SEED, ROASTED; AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; HYPERICUM PERFORATUM; GINKGO; GERMANIUM SESQUIOXIDE; SILICON DIOXIDE 1; 3; 3; 3; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0081_95c41f2a-9c4d-4b40-bfc5-0d9612803b1c 43857-0081 HUMAN PRESCRIPTION DRUG FNG II Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Nasturtium Aquaticum, Tabebuia Impetiginosa, Iodium, Adrenalinum, Argentum Metallicum, Thymus (suis), Thyroidinum (suis), Phosphoricum Acidum, Candida Albicans, Lycopodium Clavatum, Pulsatilla, Sepia LIQUID ORAL 20120927 20180927 UNAPPROVED HOMEOPATHIC BioActive Nutritional ECHINACEA, UNSPECIFIED; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; IODINE; EPINEPHRINE; SILVER; SUS SCROFA THYMUS; SUS SCROFA THYROID; PHOSPHORAMIDIC ACID; CANDIDA ALBICANS; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 43857-0082_9d32d8f7-72a0-43e3-a955-31f40d2448ef 43857-0082 HUMAN OTC DRUG Mammaryplex Echinacea, Hydrastis Canadensis, Myrrha, Phytolacca Decandra, Trigonella Foenum Graecum, Lymph, Spleen, Bryonia, Bufo Rana, Conium Maculatum, Lac Caninum, Lachesis Mutus, Silicea, Mammary Gland, LIQUID ORAL 20130213 20190702 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA, UNSPECIFIED; GOLDENSEAL; MYRRH; PHYTOLACCA AMERICANA ROOT; FENUGREEK SEED; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CONIUM MACULATUM FLOWERING TOP; CANIS LUPUS FAMILIARIS MILK; LACHESIS MUTA VENOM; SILICON DIOXIDE; HUMAN MAMMARY GLAND 3; 3; 3; 3; 3; 8; 8; 12; 12; 12; 12; 12; 12; 36 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0083_09f46139-c09a-41ad-8f47-c0046f4b7bd5 43857-0083 HUMAN OTC DRUG Bronchiforce Althaea Officinalis, Lobelia Inflata, Rheum (Officinale), Verbascum Thapsus, Belladonna, Cuprum Aceticum, Drosera (Rotundifolia), Ipecacuanha, Spongia Tosta, Sticta Pulmonaria LIQUID ORAL 20130213 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALTHAEA OFFICINALIS ROOT; LOBELIA INFLATA; RHEUM OFFICINALE ROOT; VERBASCUM THAPSUS; ATROPA BELLADONNA WHOLE; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; SPONGIA OFFICINALIS SKELETON, ROASTED; LOBARIA PULMONARIA 3; 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0084_98e00930-3406-4c3e-9e1e-e64147a7b336 43857-0084 HUMAN OTC DRUG Natural Progesterone Progesterone SPRAY ORAL 20140709 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PROGESTERONE 8 [hp_X]/mL N 20181231 43857-0085_1e5f5085-6563-4c50-aaaf-6d4b4ef9a212 43857-0085 HUMAN OTC DRUG Liver Tonic I Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Chionanthus Virginica, Quassia Amara, Hepar Bovine LIQUID ORAL 20130219 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; TARAXACUM OFFICINALE; CHIONANTHUS VIRGINICUS BARK; QUASSIA AMARA WOOD; BEEF LIVER; CEANOTHUS AMERICANUS LEAF; CITRULLUS COLOCYNTHIS FRUIT PULP; VERONICASTRUM VIRGINICUM ROOT; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TEUCRIUM MARUM 1; 1; 1; 3; 3; 8; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0086_e189499d-9da3-43fc-8a0b-9d5dd0923b11 43857-0086 HUMAN OTC DRUG Melatonin Melatonin LIQUID ORAL 20130213 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MELATONIN 6 [hp_X]/mL N 20181231 43857-0087_147dda1b-13da-49f6-9c4c-c75a4360209a 43857-0087 HUMAN OTC DRUG Bio Myelin Protein Brain (bovine), SPRAY ORAL 20121108 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BOS TAURUS BRAIN 6 [hp_X]/mL N 20181231 43857-0088_0326104f-0ea0-48d1-8b1e-e0fb7b1a49f7 43857-0088 HUMAN OTC DRUG Bio Iodine Iodium LIQUID ORAL 20130213 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. IODINE 6 [hp_X]/mL N 20181231 43857-0089_96a09e73-a1f7-454e-b70a-afa8f33b4fa4 43857-0089 HUMAN OTC DRUG Vermex Artemisia Vulgaris, Cina, Filix Mas, Spigelia Anthelmia, Teucrium Marum, Calcarea Carbonica, Graphites, Mercurius Corrosivus, Sabadilla, Silicea, Tanacetum Vulgare, Taenia Solium, Ascaris Lumbricoides LIQUID ORAL 20120927 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARTEMISIA VULGARIS ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; DRYOPTERIS FILIX-MAS ROOT; SPIGELIA ANTHELMIA; TEUCRIUM MARUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; MERCURIC CHLORIDE; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; TANACETUM VULGARE TOP; TAENIA SOLIUM; ASCARIS LUMBRICOIDES 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0090_72f42fb8-0bc0-4a66-b000-e37c576a365b 43857-0090 HUMAN OTC DRUG Stomaplex Carduus Marianus, Gentiana Lutea, Sambucus Nigra, Senna (Cassia Angustifolia), Stomach (Bovine), Arsenicum Album, Atropinum Sulphuricum, Carbo Vegetabilis, Lycopodium Clavatum, Nux Vomica, Phosphorus LIQUID ORAL 20130219 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SILYBUM MARIANUM SEED; GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; SENNA LEAF; TRIPE; ARSENIC TRIOXIDE; ATROPINE SULFATE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 3; 3; 3; 8; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0091_5f3f4f74-bc37-4389-b586-d2f18a1fc875 43857-0091 HUMAN OTC DRUG Bio Biological Detox Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Propolis, Tabebuia Impetiginosa, Thymus Serpyllum, Glandula Suprarenalis Suis, Lymph Node (Suis), Spleen (Suis), Thyroidinum (Suis), Belladonna, Hypericum Perforatum, Phosphorus, Pyrogenium, Anthracinum, Arsenicum Album, Carbolicum Acidum, Hepar Sulphuris Calcareum, Tarentula Cubensis, Variolinum, Botulinum, Bacillus Dysentery, Gaertner Bacillus, Mutabile Bacillus, Francisella Tularensis, Coxiella Burnetii, Lac Caninum SPRAY ORAL 20140729 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM AQUATICUM; PROPOLIS WAX; TABEBUIA IMPETIGINOSA BARK; THYMUS SERPYLLUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYROID; ATROPA BELLADONNA; HYPERICUM PERFORATUM; PHOSPHORUS; ARSENIC TRIOXIDE; RANCID BEEF; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BOTULINUM TOXIN TYPE A; PHENOL; CALCIUM SULFIDE; CITHARACANTHUS SPINICRUS; VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; ESCHERICHIA COLI; FRANCISELLA TULARENSIS; COXIELLA BURNETII; CANIS LUPUS FAMILIARIS MILK; PLASMODIUM MALARIAE; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; YERSINIA PESTIS; SULFUR 3; 3; 3; 3; 3; 3; 3; 5; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 15; 12; 12; 12; 12; 12; 12; 15; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0092_cc736841-36b2-4626-ad31-58cb6c05f565 43857-0092 HUMAN OTC DRUG Rheumatic Tonic II Harpagophytum Procumbens, Symphytum Officinale, Salix Alba, Colchicum Autumnale, Pinus Sylvestris, Aconitum Napellus, Arnica Montana, Gelsemium Sempervirens, Iris Versicolor, Ledum Palustre, Lespedeza Capitata, Rhus Tox, Secale Cornutum, Spigelia Anthelmia, Spiraea Ulmaria, Tartaricum Acidum LIQUID ORAL 20121113 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HARPAGOPHYTUM PROCUMBENS ROOT; COMFREY ROOT; SALIX ALBA BARK; COLCHICUM AUTUMNALE BULB; PINUS SYLVESTRIS LEAFY TWIG; ACONITUM NAPELLUS; ARNICA MONTANA; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; LEDUM PALUSTRE TWIG; LESPEDEZA CAPITATA FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM; SPIGELIA ANTHELMIA; FILIPENDULA ULMARIA ROOT; TARTARIC ACID 1; 1; 1; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0093_c1e5b50b-8635-496c-9a10-d12ebe2ad709 43857-0093 HUMAN OTC DRUG Dentaforce Antimonium Crudum, Belladonna, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Hekla Lava, Mercurius Solubilis, Plumbum Metallicum, Sepia, Silicea, Hydrofluoricum Acidum LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANTIMONY TRISULFIDE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; HEKLA LAVA; MERCURIUS SOLUBILIS; LEAD; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; HYDROFLUORIC ACID 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0094_e21ed933-f723-4a16-93bf-b198cd556ee3 43857-0094 HUMAN OTC DRUG Apizelen Alfalfa, Avena Sativa, Chelidonium Majus, Aralia Quinquefolia, Beta Vulgaris, Calendula Officinalis, Cuprum Aceticum, Echinacea, Natrum Muriaticum, Oxalis Acetosella, Paloondo, Phytolacca Decandra, Trifolium Pratense, Urtica Dioica, Viscum Album, Cobalt Aceticum, Cobalt Gluconate, Copper Gluconate, Glutathione, Magnesium Gluconate, Ubiquinone, Ling Chi, Argentum Metallicum, Germanium Metallicum LIQUID ORAL 20121109 20190708 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; CHELIDONIUM MAJUS; AMERICAN GINSENG; BETA VULGARIS; CALENDULA OFFICINALIS FLOWERING TOP; CUPRIC ACETATE; ECHINACEA ANGUSTIFOLIA; SODIUM CHLORIDE; OXALIS ACETOSELLA LEAF; LARREA TRIDENTATA TOP; PHYTOLACCA AMERICANA ROOT; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA; VISCUM ALBUM FRUITING TOP; COBALTOUS ACETATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; GLUTATHIONE; MAGNESIUM GLUCONATE; UBIDECARENONE; REISHI; SILVER; GERMANIUM 1; 1; 1; 2; 2; 2; 2; 2; 2; 2; 2; 2; 2; 2; 2; 3; 3; 3; 3; 3; 3; 4; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0096_bcb71d09-e831-4adb-bd4c-ad130ab44c4f 43857-0096 HUMAN OTC DRUG HZ Formula Baptisia Tinctoria, Echinacea, Lomatium Dissectum, Tabebuia Impetiginosa, Propolis, Spleen (suis), Thymus (suis), Thyroidinum (suis), Gelsemium sempervirens, Lycopodium clavatum, Nux vomica, Chlamydia trachomatis, Herpes I, Herpes II, Candida albicans, Human papilloma virus, Trichinella spiralis LIQUID ORAL 20130213 20190121 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; LOMATIUM DISSECTUM ROOT; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SUS SCROFA THYROID; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; CHLAMYDIA TRACHOMATIS; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; CANDIDA ALBICANS; HUMAN PAPILLOMAVIRUS; TRICHINELLA SPIRALIS 3; 3; 3; 3; 6; 6; 6; 6; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0097_b60d8bfd-6c07-4b94-af11-c1b0b9ecda61 43857-0097 HUMAN OTC DRUG Anxiety II HP Aconitum Napellus, Arsenicum Album, Belladonna, Calcarea Carbonica, Carcinosin, Causticum, Gelsemium Sempervirens, Lachesis Mutus, Mercurius Vivus, Nitricum Acidum, Phosphorus, Rhus Tox SPRAY ORAL 20121109 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; HUMAN BREAST TUMOR CELL; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; MERCURY; NITRIC ACID; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0099_2fd2e15a-ba38-46b1-bdbd-f33a84033de9 43857-0099 HUMAN OTC DRUG ASP Echinacea, Hydrastis Canadensis, Tabeuia Impetiginosa, Glandula Suprarenalis Suis, Thymus (Suis), Thyroidinum (Suis), Arsenicum Album, Bryonia, Cocculus Indicus, Colchicum Autumnale, Ledum Palustre, Mercurius Cyanatus, Natrum Sulphuricum, Pulsatilla, Sepia, Silicea, Aspergillus Flavus LIQUID ORAL 20121112 20181021 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; TABEBUIA IMPETIGINOSA BARK; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; THYROID, PORCINE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; LEDUM PALUSTRE TWIG; MERCURIC CYANIDE; SODIUM SULFATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; ASPERGILLUS FLAVUS 3; 3; 3; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0100_b2be5449-70f1-4255-b749-fb4bdf8ce91c 43857-0100 HUMAN OTC DRUG Pneumoforce Althaea Officinalis, Natrum Carbonicum, Rheum (Officinale), Verbascum Thapsus, Zingiber Officinale, Aconitum Napellus, Drosera (Rotundifolia), Kali Bichromicum, Lobelia Inflata, Phosphorus LIQUID ORAL 20130212 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALTHAEA OFFICINALIS ROOT; SODIUM CARBONATE; RHEUM OFFICINALE ROOT; VERBASCUM THAPSUS; GINGER; ACONITUM NAPELLUS; DROSERA ROTUNDIFOLIA; POTASSIUM DICHROMATE; LOBELIA INFLATA; PHOSPHORUS 3; 3; 3; 3; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0101_27c40ef5-48b7-411c-aee9-8d2c2794037c 43857-0101 HUMAN OTC DRUG FNG I Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Nasturtium Aquaticum, Tabebuia Impetiginosa, Condurango, Ginko Biloba, Ligusticum Porteri, Astragalus Membranaceus, Propolis, Glandula Suprarenalis (Bovinum), Thymus (Bovinum), Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Phytolacca Decandra, Sepia, Alternaria Tenuis, Aspergillus Niger, Rhizopus Nigricans, Mucor Racemosus, Pullaria Pullulans, Candida Albicans, Candida Parapsilosis, Torula Cerevisiae LIQUID ORAL 20130212 20190227 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA, UNSPECIFIED; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; MARSDENIA CONDURANGO BARK; GINKGO; LIGUSTICUM PORTERI ROOT; ASTRAGALUS PROPINQUUS ROOT; PROPOLIS WAX; BOS TAURUS ADRENAL GLAND; BOS TAURUS THYMUS; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; RHIZOPUS STOLONIFER; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; SACCHAROMYCES CEREVISIAE 3; 3; 3; 3; 3; 4; 4; 4; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0102_aae7a690-7b3d-4dc8-8c6d-319ff1fd6663 43857-0102 HUMAN PRESCRIPTION DRUG Androbalance Androstenedione, Dehydroepiandrosterone, Pregnenolone, Progesterone, Testosterone LIQUID ORAL 20121026 20180422 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANDROSTENEDIONE; 7-OXO-PRASTERONE; PREGNENOLONE; PROGESTERONE; TESTOSTERONE 6; 6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Progesterone [Chemical/Ingredient],Progesterone [EPC],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 43857-0103_0fbb882f-ea06-4d40-be08-8fef05705c57 43857-0103 HUMAN OTC DRUG Progesterone Progesterone LIQUID ORAL 20130212 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PROGESTERONE 6 [hp_X]/mL N 20181231 43857-0104_ce548e72-76b8-423b-b9b1-373c634efcfb 43857-0104 HUMAN OTC DRUG Pancreaplex Chelidonium Majus, Glycyrrhiza Glabra, Hydrastis Canadensis, Nux Moschata, Rheum Officinale, Syzygium Jambolanum LIQUID ORAL 20121228 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; GLYCYRRHIZA GLABRA; GOLDENSEAL; NUTMEG; RHEUM OFFICINALE ROOT; SYZYGIUM CUMINI SEED; TARAXACUM OFFICINALE; GINGER; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PANCREAS; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; KIDNEY BEAN; PHOSPHORIC ACID; PHOSPHORUS 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0106_28040bf3-bd52-42ec-b90c-6a6b15bbdc1f 43857-0106 HUMAN OTC DRUG Inflammation I Echinacea (Angustifolia), Hydrastis Canadensis, Nasturtium Aquaticum, Phytolacca Decandra, Apis Mellifica, Belladonna, Ferrum Phosphoricum, Nitricum Acidum, Oleander, Silicea LIQUID ORAL 20130212 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; APIS MELLIFERA; ATROPA BELLADONNA WHOLE; FERROSOFERRIC PHOSPHATE; NITRIC ACID; NERIUM OLEANDER LEAF; SILICON DIOXIDE 3; 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0107_5a4df7d6-7c83-4304-830a-dc554dfb36ff 43857-0107 HUMAN OTC DRUG Liver Tonic III Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Chionanthus Virginica, Quassia Amara, Hepar Sulphuris Calcareum, Hepar Bovinum, Ceanothus Americanus, Colocynthis, Leptandra Virginica, Natrum Sulphuricum, Nux Vomica, Phosphorus, Teucrium Marum, Hepatitis A, Hepatitis B, Hepatitis C LIQUID ORAL 20121226 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MILK THISTLE; CHELIDONIUM MAJUS; TARAXACUM OFFICINALE; CHIONANTHUS VIRGINICUS BARK; QUASSIA AMARA WOOD; CALCIUM SULFIDE; BEEF LIVER; CEANOTHUS AMERICANUS LEAF; CITRULLUS COLOCYNTHIS FRUIT PULP; VERONICASTRUM VIRGINICUM ROOT; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TEUCRIUM MARUM; HEPATITIS A VIRUS; HEPATITIS B VIRUS; HEPATITIS C VIRUS 1; 1; 1; 3; 3; 8; 8; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0108_1865ac26-9e8e-4039-bf92-bd74cf8e5b8d 43857-0108 HUMAN OTC DRUG Bio Res Q Clematis Vitalba Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos LIQUID ORAL 20140903 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0109_86d58480-746d-42a5-828d-56eee3fb266b 43857-0109 HUMAN OTC DRUG Viscumforce Passiflora Incarnata, Valeriana Officinalis, Aurum Metallicum, Baryta Carbonica, Glonoinum, Phosphorus, Plumbum Metallicum, Viscum Album LIQUID ORAL 20130211 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; GOLD; BARIUM CARBONATE; NITROGLYCERIN; PHOSPHORUS; LEAD; VISCUM ALBUM FRUITING TOP 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 43857-0110_3ecb4433-bb15-4661-a6bd-460eae736e79 43857-0110 HUMAN OTC DRUG Hepataplex Beta Vulgaris, Boldo, Carduus Marianus, Chelidonium Majus, Petroselinum Sativum, Taraxacum Officinale, Glutathione, Hepar suis, Lycopodium clavatum, Nux vomica, Phosphorus LIQUID ORAL 20130211 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BETA VULGARIS; PEUMUS BOLDUS LEAF; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; PETROSELINUM CRISPUM; TARAXACUM OFFICINALE; GLUTATHIONE; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 3; 3; 3; 3; 3; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0111_e951e1e5-bf9d-4ca4-82fd-090e6e2039a7 43857-0111 HUMAN OTC DRUG Coxsackie Coxsackie B1, B4 LIQUID ORAL 20121009 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4 200; 200 [hp_C]/mL; [hp_C]/mL N 20181231 43857-0112_57e61027-ae60-4269-b664-d1c4e3cb8a63 43857-0112 HUMAN OTC DRUG Adaptagen Aralia Quinquefolia, Avena Sativa, Capsicum Annuum, Ginkgo Biloba, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Thiaminum Hydrochloricum, Ascorbic Acid, Riboflavinum, Glandula Suprarenalis Suis, Spleen (Suis), Thyroidinum (Suis), Cuprum Gluconate, Iodium, Ledum Palustre, Molybdenum Metallicum, Natrum Carbonicum, Phosphoricum Acidum, Picricum Acidum, Selenium Metallicum, Sepia, Vanadium Metallicum, Adenosine Triphosphate LIQUID ORAL 20130208 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; CAPSICUM; GINKGO; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; THIAMINE HYDROCHLORIDE; ASCORBIC ACID; RIBOFLAVIN; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYROID; COPPER GLUCONATE; IODINE; LEDUM PALUSTRE TWIG; MOLYBDENUM; SODIUM CARBONATE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM; SEPIA OFFICINALIS JUICE; VANADIUM; ADENOSINE TRIPHOSPHATE 3; 3; 3; 3; 3; 3; 4; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0113_ae7f4d21-de97-4d88-acfa-500340edd1e5 43857-0113 HUMAN OTC DRUG Venoforce I Aesculus Hippocastanum, Collinsonia Canadensis, Echinacea, Hamamelis Virginiana, Pulsatilla, Arnica Montana LIQUID ORAL 20130208 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HORSE CHESTNUT; COLLINSONIA CANADENSIS ROOT; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PULSATILLA VULGARIS; ARNICA MONTANA; ACTIVATED CHARCOAL; GRAPHITE; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; SEPIA OFFICINALIS JUICE 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0114_5cd1b7c9-f85f-40cd-854f-f1b21465bbe4 43857-0114 HUMAN OTC DRUG Adrenoplex Chelidonium Majus, Echinacea, Glandula Suprarenalis Bovinum, Spleen, Carduus Marianus, Lycopodium Clavatum, Natrum Muriaticum, Phosphoricum Acidum, LIQUID ORAL 20130208 20180806 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; BOS TAURUS ADRENAL GLAND; SUS SCROFA SPLEEN; SILYBUM MARIANUM SEED; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORIC ACID 3; 3; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0115_5ddadacb-709e-4bad-80f7-2d2e1245bcfe 43857-0115 HUMAN OTC DRUG Bone Repair HP Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Fluoricum Acidum, Hekla Lava, Rhus Tox, Silicea, Symphytum Officinale LIQUID ORAL 20130130 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; HYDROFLUORIC ACID; HEKLA LAVA; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; COMFREY ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0116_3336d241-3848-45f7-a423-6cb2b1a6c4ad 43857-0116 HUMAN OTC DRUG Kidney Tonic I Echinacea (Angustifolia), Petroselinum Sativum, Solidago Virgaurea, Uva-Ursi, Pareira Brava, Glutathione, Kidney (Suis), Cantharis, Lycopodium Clavatum LIQUID ORAL 20121217 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; PETROSELINUM CRISPUM; SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; GLUTATHIONE; PORK KIDNEY; LYTTA VESICATORIA; LYCOPODIUM CLAVATUM SPORE 1; 1; 1; 1; 3; 6; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0117_37b2dd52-456c-47e3-bed9-9de6ba21e39c 43857-0117 HUMAN OTC DRUG Bio Cherry Plum Cherry Plum LIQUID ORAL 20130130 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PRUNUS CERASIFERA FLOWER 6 [hp_X]/mL N 20181231 43857-0118_c07f31e1-0ae7-4398-b8fb-aa8327638569 43857-0118 HUMAN OTC DRUG Bio Oak Oak LIQUID ORAL 20130130 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. QUERCUS ALBA BARK 6 [hp_X]/mL N 20181231 43857-0119_19a44ab3-df03-4305-a5e4-ec5a07757fe4 43857-0119 HUMAN OTC DRUG Spleen Spleen (bovine) LIQUID ORAL 20121008 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BOS TAURUS SPLEEN 6 [hp_X]/mL N 20181231 43857-0120_3e71dad7-f95c-4e1f-9246-29ca542c2101 43857-0120 HUMAN OTC DRUG Progesterone Progesterone LIQUID ORAL 20121009 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PROGESTERONE 6 [hp_X]/mL N 20181231 43857-0121_e8561ebd-bb3d-4c74-a835-5d91519cb329 43857-0121 HUMAN OTC DRUG Bio Electrolyte Boron Gluconate, Calcium Gluconate, Chromium Gluconate, Cobalt Gluconate, Copper Gluconate, Ferrous Gluconate, Magnesium Gluconicum Dihydrate, Manganese Gluconate, Nickel Gluconate, Potassium Gluconate, Selenium Gluconate, Zincum Gluconicum, Kali Phosphoricum, Vanadium Metallicum, Calcarea Phosphorica LIQUID ORAL 20130129 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BORON GLUCONATE; CALCIUM GLUCONATE; CHROMIUM GLUCONATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; FERROUS GLUCONATE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; NICKEL GLUCONATE; POTASSIUM GLUCONATE; SELENIUM DIOXIDE; SODIUM GLUCONATE; ZINC GLUCONATE; DIBASIC POTASSIUM PHOSPHATE; VANADIUM; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0122_00e34254-135a-4ec1-8071-6df54cf52045 43857-0122 HUMAN OTC DRUG Osteoforce Bone, Calcarea Carbonica, Calcarea Fluorica, Causticum, Cocculus Indicus, Ledum Palustre, Phosphoricum Acidum, Rhus Toxicodendron LIQUID ORAL 20130125 20190304 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SUS SCROFA BONE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; ANAMIRTA COCCULUS SEED; LEDUM PALUSTRE TWIG; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0123_24c12661-ff0c-40a0-a64e-038e1e0a491c 43857-0123 HUMAN OTC DRUG GABA Gaba (Gamma-Aminobutyric Acid) LIQUID ORAL 20141003 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .GAMMA.-AMINOBUTYRIC ACID 6 [hp_X]/mL N 20181231 43857-0126_5a80f8c8-b8fa-4b4e-b288-ff2796bdd7c2 43857-0126 HUMAN OTC DRUG Histamine Histaminum Hydrochloricum LIQUID ORAL 20130307 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HISTAMINE DIHYDROCHLORIDE 6 [hp_X]/mL N 20181231 43857-0127_903a2dae-39ac-4d13-8290-8ab6469c3a25 43857-0127 HUMAN OTC DRUG Anti Hive Ammonium Carbonicum, Apis Mellifica, Argentum Metallicum, Arsenicum Album, Dulcamara, Mezereum, Rhus Tox, Urtica Urens LIQUID ORAL 20130307 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMMONIUM CARBONATE; APIS MELLIFERA; SILVER; ARSENIC TRIOXIDE; SOLANUM DULCAMARA TOP; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0128_55b17f16-725e-4631-8228-9662f9c4ce0a 43857-0128 HUMAN OTC DRUG Arrythmiaforce Convallaria Majalis, Juglans Nigra, Leonurus Cardiaca, Adonis Vernalis, Magnesia Sulphurica, Kali Chloricum LIQUID ORAL 20130307 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CONVALLARIA MAJALIS; BLACK WALNUT; LEONURUS CARDIACA; ADONIS VERNALIS; MAGNESIUM SULFATE HEPTAHYDRATE; POTASSIUM CHLORATE; IBERIS AMARA SEED; DIGITALIS; LYCOPUS VIRGINICUS; PHOSPHORUS 3; 3; 3; 4; 4; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0129_fda88d2d-0e7a-4f86-942b-aad9e43b51b3 43857-0129 HUMAN OTC DRUG Bio Impatiens Impatiens Glandulifera, Flos LIQUID ORAL 20130311 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. IMPATIENS GLANDULIFERA FLOWER 6 [hp_X]/mL N 20181231 43857-0130_58ab93af-c7a8-4010-a051-d7ef51ccff8b 43857-0130 HUMAN OTC DRUG Glutathione Glutathione LIQUID ORAL 20130228 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. GLUTATHIONE 6 [hp_X]/mL N 20181231 43857-0131_fd47bef5-8cdd-444d-b145-2f531a4f611a 43857-0131 HUMAN OTC DRUG Arthritis HP Apis Mellifica, Bryonia, Causticum, Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre, Pulsatilla, Rhododendron Chrysanthum, Rhus Tox LIQUID ORAL 20130220 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; BRYONIA ALBA ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0132_021c7192-3023-4891-a0ab-470e4ce980f6 43857-0132 HUMAN OTC DRUG Pneumotox Triticum Aestivum, Alfalfa, Arnica Montana, Asclepias Tuberosa, Chamomilla, Echinacea, Eucalyptus Globulus, Fucus Vesiculosus, Hordeum Vulgare, Laminaria Digitata, Nasturtium Aquaticum, Plantago Major, Raphanus, Symphytum Officinale, Trifolium Pratense, Trigonella Foenum-Graecum, Orzya Sativa, Lung (Suis), Silicea, Arsenicum Album, Natrum Muriaticum, Nitricum Acidum, Phellandrium Aquaticum, Phosphoricum Acidum, Phosphorus, Pulsatilla (Vulgaris), RhusToxicodendron, Acetone, Sodium Tripolyphosphate, LIQUID ORAL 20130924 20180510 UNAPPROVED HOMEOPATHIC BioActive Nutritional TRITICUM AESTIVUM WHOLE; ALFALFA; ARNICA MONTANA; ASCLEPIAS TUBEROSA FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; EUCALYPTUS GLOBULUS LEAF; FUCUS VESICULOSUS; HORDEUM VULGARE TOP; LAMINARIA DIGITATA; NASTURTIUM AQUATICUM; PLANTAGO MAJOR; RAPHANUS SATIVUS; COMFREY ROOT; TRIFOLIUM PRATENSE FLOWER; FENUGREEK SEED; BROWN RICE; SUS SCROFA LUNG; SILICON DIOXIDE; ACETONE; SODIUM TRIPOLYPHOSPHATE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; AMMONIUM CHLORIDE; SODIUM LAURYL SULFATE; TURPENTINE OIL; ARSENIC TRIOXIDE; SODIUM CHLORIDE; NITRIC ACID; OENANTHE AQUATICA FRUIT; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; PARAFFIN; ETHYLENE GLYCOL; PROPYL ALCOHOL; PALMITIC ACID; DIMETHICONE; SODIUM POLYACRYLATE (8000 MW); GLUTARAL; METHYL METHACRYLATE; ANHYDROUS CITRIC ACID; TARTARIC ACID; ANTHRAQUINONE; HYDROGEN PEROXIDE; GLYCOLIC ACID; AMMONIUM THIOGLYCOLATE; SODIUM CARBONATE; ETHANOLAMINE; 2,5-DIAMINOTOLUENE SULFATE; P-AMINOPHENOL 1; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 8; 8; 8; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0133_78fce4ef-dff7-4bb0-b61e-58d9ce59d3fd 43857-0133 HUMAN OTC DRUG Lymphoplex Myrrha, Trigonella Foenum Graecum, Pinus Sylvestris, Lymph, Spleen, Conium Maculatum, Echinacea, Hepar Sulphuris Calcareum, Hydrangea Arborescens, Phytolacca Decandra, Silicea LIQUID ORAL 20130117 20180927 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MYRRH; FENUGREEK SEED; PINUS SYLVESTRIS LEAFY TWIG; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; CALCIUM SULFIDE; HYDRANGEA ARBORESCENS ROOT; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE 3; 3; 6; 8; 8; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0134_f3ecb03e-f67e-4189-86a4-3446980a0316 43857-0134 HUMAN OTC DRUG Bio Mimulus Mimulus Guttatus, Flos LIQUID ORAL 20130311 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MIMULUS GUTTATUS FLOWERING TOP 6 [hp_X]/mL N 20181231 43857-0135_4d8223c9-82c1-4f9c-a097-141a930f9693 43857-0135 HUMAN OTC DRUG Vax Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Tabebuia Impetiginosa, Trifolium Pratense, Arnica Montana, Calendula Officinalis, Chelidonium Majus, Leptandra Virginica, Ligusticum Porteri, Lomation Dissectum, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Taraxacum Officinale, Trigonella Foenum-Graecum, Urtica Dioica, Astragalus Membranaceus, Propolis, Glandula Suprarenalis Suis, Thymus (Suis), Arsenicum Album, Belladonna, Chamomilla, Lycopodiuim Clavatum, Rhus Toxicodendron LIQUID ORAL 20130114 20181216 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL; TABEBUIA IMPETIGINOSA BARK; TRIFOLIUM PRATENSE FLOWER; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; FENUGREEK SEED; URTICA DIOICA; ASTRAGALUS PROPINQUUS ROOT; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; MATRICARIA RECUTITA; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; ANTIMONY TRISULFIDE; DIPHENYLTRICHLOROETHANE; THIMEROSAL 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 6; 6; 8; 8; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0136_fd6b4539-44c5-414d-8134-1ba1f7c12053 43857-0136 HUMAN OTC DRUG Nephroplex Berberis Vulgaris, Hydrangea Arborescens, Petroselinum Sativum, Solidago Virgaurea, Uva Ursi, Rubia Tinctorum, Glutathione, Kidney (Suis), Bryonia (Alba), Eupatorium Purpureum, Mercurius Corrosivus LIQUID ORAL 20130114 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; HYDRANGEA ARBORESCENS ROOT; PETROSELINUM CRISPUM; SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; RUBIA TINCTORUM ROOT; GLUTATHIONE; PORK KIDNEY; BRYONIA ALBA ROOT; EUTROCHIUM PURPUREUM ROOT; MERCURIC CHLORIDE 3; 3; 3; 3; 3; 5; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0137_05dff914-0691-4fc0-9686-5e9e82116fd5 43857-0137 HUMAN OTC DRUG Prostatone Echinacea, Hydrastis Canadensis, Phytolacca Decandra, Sabal Serrulata, Sarsaparilla, Solidago Virgaurea LIQUID ORAL 20130227 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA, UNSPECIFIED; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; SAW PALMETTO; SMILAX REGELII ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; ZINC SULFATE HEPTAHYDRATE; SUS SCROFA TESTICLE; SUS SCROFA PROSTATE; CLEMATIS RECTA FLOWERING TOP; PHOSPHORIC ACID; PULSATILLA VULGARIS 3; 3; 3; 3; 3; 3; 3; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0138_88b92968-2286-444b-a39c-c7ac8492e821 43857-0138 HUMAN OTC DRUG Acetylcholine Chloride Acetylcholine Chloride LIQUID ORAL 20130228 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACETYLCHOLINE CHLORIDE 6 [hp_X]/mL N 20181231 43857-0139_0cf98588-e413-4285-8ccc-c905cab0f7a0 43857-0139 HUMAN OTC DRUG Rheumaforce Chondrus Crispus, Cimicifuga Racemosa, Spiraea Ulmaria, Symphytum Officinale, Trifolium Pratense, Urtica Urens LIQUID ORAL 20130114 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHONDRUS CRISPUS; BLACK COHOSH; FILIPENDULA ULMARIA ROOT; COMFREY ROOT; TRIFOLIUM PRATENSE FLOWER; URTICA URENS; ZANTHOXYLUM AMERICANUM BARK; COLCHICUM AUTUMNALE BULB; FERROSOFERRIC PHOSPHATE; FORMICA RUFA; LITHIUM CARBONATE; SODIUM SULFATE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0140_8ca90d75-d5e4-45d2-b0c9-4fdebba3de6f 43857-0140 HUMAN OTC DRUG Bio Chicory Chicory LIQUID ORAL 20130228 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHICORY ROOT 6 [hp_X]/mL N 20181231 43857-0141_16116c78-6dc4-430b-8d2a-ff92c2f5ba3b 43857-0141 HUMAN OTC DRUG Occuloplex G Euphrasia Officinalis, Ginkgo Biloba, Petroselinum Sativum, Spigelia Anthelmia, Vaccinium Myrtillus, Ascorbic Acid, Eye (Suis), Germanium Sesquioxide, Lithium Metallicum), Ubidecarenonum, Aurum Metallicum, Bryonia (Alba), Hepar Sulphuris Calcareum, Phosphorus, Ruta Graveolens, Sulphur LIQUID ORAL 20130116 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. EUPHRASIA STRICTA; GINKGO; PETROSELINUM CRISPUM; SPIGELIA ANTHELMIA; BILBERRY; ASCORBIC ACID; SUS SCROFA EYE; GERMANIUM SESQUIOXIDE; LITHIUM; UBIDECARENONE; GOLD; BRYONIA ALBA ROOT; CALCIUM SULFIDE; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP OIL; SULFUR 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0142_58e83756-3f61-475b-86af-984d8cd71199 43857-0142 HUMAN OTC DRUG Insomnia HP Arsenicum Album, Coffea Cruda, Kali Carbonicum, Magnesia Carbonica, Nux Vomica, Passiflora Incarnata, Sepia, Valeriana Officinalis LIQUID ORAL 20130409 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; ARABICA COFFEE BEAN; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; SEPIA OFFICINALIS JUICE; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0143_7256c616-0a78-4281-b531-36956c6f2651 43857-0143 HUMAN OTC DRUG Lipotox Squalene, Cholesterinum, Estrogen, Progesterone, Aspartame, Benzalkonium chloride, Formalinum, Methylene chloride LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SQUALENE; CHOLESTEROL; ESTRONE; ESTRIOL; ESTRADIOL; PROGESTERONE; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE; ARSENIC ACID; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; CORTICOTROPIN; XYLITOL; ISOPROPYL PALMITATE; PETROLATUM; SALICYLIC ACID; ACETIC ACID; CORTISONE ACETATE; BENZOIC ACID; LACTIC ACID; EUGENOL; BORIC ACID; SORBITOL; POTASSIUM SORBATE; BENZYL ALCOHOL; STEARYL ALCOHOL; RESORCINOL; PHENYLBUTAZONE; LEAD; CHLORINE 8; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0144_399f919a-93fe-4b1c-88e9-b5407c89d1fc 43857-0144 HUMAN OTC DRUG Edemaforce Cactus Grandiflorus, Calendula Officinalis, Convallaria Majalis, Dulcamara, Leptandra Virginica, Solidago Virgaurea, Apis Mellifica, Arnica Montana, Berberis Vulgaris, Bryonia, Chelidonium Majus, Lycopodium Clavatum, Plumbum Metallicum, Sambucus Nigra LIQUID ORAL 20130315 20190715 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SELENICEREUS GRANDIFLORUS STEM; CALENDULA OFFICINALIS FLOWERING TOP; CONVALLARIA MAJALIS; SOLANUM DULCAMARA TOP; VERONICASTRUM VIRGINICUM ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; LEAD; SAMBUCUS NIGRA FLOWERING TOP 3; 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0145_d380b0f9-41e4-4e9e-a1f9-2a29c9d26574 43857-0145 HUMAN OTC DRUG Allergen II Kali Gluconicum, Adrenalinum, Hepar, Sheep Sorrel, Yellow Dock, Kentucky Blue Grass, Orchard Grass, Red Top Grass, Timothy Grass, Goldenrod, Red Clover, False Ragweed, Short Ragweed, Tall Ragweed, Western Ragweed, Ash, Beech, Red Birch, Box Elder, Cottonwood, Elm, Hickory, Red Oak, Sycamore, Black Walnut, Black Willow, Arsenicum Album, Phosphorus, Pulsatilla, Sulphur, Histaminum Hydrochloricum LIQUID ORAL 20120222 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. POTASSIUM GLUCONATE; EPINEPHRINE; BEEF LIVER; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; POA PRATENSIS TOP; DACTYLIS GLOMERATA TOP; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIFOLIUM PRATENSE FLOWER; ALFALFA; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA; AMBROSIA TRIFIDA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; CARYA OVATA POLLEN; QUERCUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; HISTAMINE DIHYDROCHLORIDE 6; 8; 8; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0146_94cd9835-6856-45d6-b9a5-d611ec0bc8f7 43857-0146 HUMAN OTC DRUG Weed and Grass Antigen Alfalfa, Amaranth, Cocklebur, Taraxacum Officinale, Solidago Viragaurea, Kentucky Blue Grass, Lambs Quarter, Marsh Elder, Meadow Fescue, Mugwort, Orchard Grass, Rye Perennial, Trifolium Pratense, Red Top Grass, Rough Red Root Pig Weed, Sagebrush, Spiny Pig Weed, Sweet Vernal Grass, Timothy Grass, Western Ragweed, Trifolium Repens, Sheep Sorrel, Yellow Dock, Allium Cepa, Arsenicum Album, Nux Vomica, Pulsatilla (Vulgaris) LIQUID ORAL 20130308 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALFALFA; AMARANTHUS PALMERI POLLEN; AGRIMONIA EUPATORIA; TARAXACUM OFFICINALE; SOLIDAGO VIRGAUREA FLOWERING TOP; POA PRATENSIS TOP; CHENOPODIUM ALBUM WHOLE; IVA ANNUA POLLEN; FESTUCA PRATENSIS TOP; ARTEMISIA VULGARIS ROOT; DACTYLIS GLOMERATA TOP; LOLIUM PERENNE POLLEN; TRIFOLIUM PRATENSE FLOWER; AGROSTIS GIGANTEA TOP; AMARANTHUS RETROFLEXUS POLLEN; ARTEMISIA TRIDENTATA POLLEN; AMARANTHUS SPINOSUS POLLEN; ANTHOXANTHUM ODORATUM; PHLEUM PRATENSE TOP; AMBROSIA PSILOSTACHYA POLLEN; TRIFOLIUM REPENS FLOWER; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS TOP; ONION; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0147_8089c806-e1b2-4a0a-9912-dd8d4e1d18cc 43857-0147 HUMAN OTC DRUG Pancreaforce Juniperus Virginiana, Lappa Major, Rhamnus Purshiana, Syzygium Jambolanum, Chelidonium Majus, Lycopodium Clavatum, Myrtus Communis, Natrum Sulphuricum, Phosphoricum Acidum, Phosphorus, Tarentula Cubensis LIQUID ORAL 20130409 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. JUNIPERUS VIRGINIANA TWIG; ARCTIUM LAPPA ROOT; FRANGULA PURSHIANA BARK; SYZYGIUM CUMINI SEED; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; MYRTUS COMMUNIS TOP; SODIUM SULFATE; PHOSPHORIC ACID; PHOSPHORUS; CITHARACANTHUS SPINICRUS 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0148_48384b25-12ba-4098-855d-f375e0c0fe2f 43857-0148 HUMAN OTC DRUG Diathesis III Heart (Suis), Small Intestine (Suis), Germanium Sesquioxide, Cobaltum Metallicum, Cysteinum, Manganum Metallicum, Manganese Gluconate, alpha-Ketoglutaricum Acidum, Arsenicum Album, Aurum Metallicum, Fumaricum Acidum, Natrum Oxalaceticum, Phosphorus LIQUID ORAL 20130416 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PORK HEART; PORK INTESTINE; GERMANIUM SESQUIOXIDE; COBALT; CYSTEINE; MANGANESE; MANGANESE GLUCONATE; .ALPHA.-KETOGLUTARIC ACID; ARSENIC TRIOXIDE; GOLD; FUMARIC ACID; SODIUM DIETHYL OXALACETATE; PHOSPHORUS 6; 6; 8; 9; 9; 9; 10; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0149_edc54e45-9589-4d49-ab67-0df094edddf6 43857-0149 HUMAN OTC DRUG Gaba Gaba LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .GAMMA.-AMINOBUTYRIC ACID 6 [hp_X]/mL N 20181231 43857-0150_f57f2fdf-83fd-4400-9f42-28710cda6fba 43857-0150 HUMAN OTC DRUG Estrogen Folliculinum, Oophorinum (Suis) LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ESTRONE; SUS SCROFA OVARY 6; 6 [hp_X]/mL; [hp_X]/mL N 20181231 43857-0151_d8c3ce0f-e576-4e06-a4d8-60378802df4b 43857-0151 HUMAN OTC DRUG Naja Forte X Naja Tripudians LIQUID ORAL 20130403 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. NAJA NAJA VENOM 9 [hp_X]/mL N 20181231 43857-0152_885577e1-59ea-479b-9015-2ee58620e1bf 43857-0152 HUMAN OTC DRUG HZ HP Lycopodium Clavatum, Natrum Muriaticum, Nitricum Acidum, Ranunculus Bulbosus, Rhus Tox, Sepia, Thuja Occidentalis LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; NITRIC ACID; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAF 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0154_a61cf102-44c9-40ca-afaf-b60b53f73c32 43857-0154 HUMAN OTC DRUG Influaforce Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Propolis, Bryonia (Alba), Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Ipecacuanha, Mercurius Corrosivus, Pyrogenium, Influenzinum LIQUID ORAL 20140918 20191015 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; MERCURIC CHLORIDE; RANCID BEEF; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 30; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0155_a8267510-8c2c-4499-a35d-ac9f21237d91 43857-0155 HUMAN OTC DRUG Amoebatox Triticum Aestivum, Baptisia Tinctoria, Capsicum Annuum, Columbo, Fragaria Vesca, Hamamelis Virginiana LIQUID ORAL 20130415 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRITICUM AESTIVUM WHOLE; BAPTISIA TINCTORIA ROOT; CAPSICUM; JATEORHIZA CALUMBA ROOT; ALPINE STRAWBERRY; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; GOLDENSEAL; QUASSIA AMARA WOOD; SENNA LEAF; BEEF LIVER; SUS SCROFA PANCREAS; BOS TAURUS SPLEEN; ATROPA BELLADONNA WHOLE; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; AMOEBA PROTEUS; GIARDIA LAMBLIA 1; 3; 3; 3; 3; 3; 3; 3; 3; 8; 8; 8; 12; 12; 12; 12; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0156_9d5ff5a5-aa57-431d-8387-ee37ee42827d 43857-0156 HUMAN OTC DRUG Bio Mustard Sinapis Arvensis, Flos LIQUID ORAL 20121009 UNAPPROVED HOMEOPATHIC BioActive Nutritional SINAPIS ARVENSIS FLOWERING/FRUITING TOP 6 [hp_X]/mL N 20181231 43857-0157_2600d947-025d-41b8-9dec-24a98adeedcd 43857-0157 HUMAN OTC DRUG Sinus Tonic Echinacea, Baptisia Tinctoria, Hydrastis Canadensis, Thiaminum Hydrochloricum, Pantothenic Acid, Pyridoxinum Hydrochloricum, Spongia Tosta, Apis Mellifica, Ascorbic Acid, Hepar Sulphuris Calcareum, Kali Bichromicum, Lachesis Mutus, Merdurius Iodatus Ruber, Merdcurius Sulphuratus Ruber, Pulsatilla, Silicea, Sinusitisinum LIQUID ORAL 20130410 20180402 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; THIAMINE HYDROCHLORIDE; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; APIS MELLIFERA; ASCORBIC ACID; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MERCURIC IODIDE; MERCURIC SULFIDE; PULSATILLA VULGARIS; SILICON DIOXIDE; SINUSITISINUM 2; 3; 3; 4; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0158_6df0d202-6957-4b73-a482-e30b9b82d4d4 43857-0158 HUMAN OTC DRUG Renaforce Berberis Vulgaris, Echinacea, Coccus Cacti, Kali Muriaticum, Lycopodium Clavatum, Nitricum Acidum LIQUID ORAL 20130920 20181127 UNAPPROVED HOMEOPATHIC BioActive Nutritional BERBERIS VULGARIS ROOT BARK; ECHINACEA, UNSPECIFIED; PROTORTONIA CACTI; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0159_89910b9e-d250-4bc3-b982-e33a11ba28ee 43857-0159 HUMAN OTC DRUG Arterioforce I Arnica Montana, Lilium Tigrinum, Aurum Muriaticum, Cactus Grandiflorus, Digitalis Purpurea, Glonoinum, Nux Vomica, Veratrum Album LIQUID ORAL 20130417 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; LILIUM LANCIFOLIUM WHOLE FLOWERING; GOLD TRICHLORIDE; SELENICEREUS GRANDIFLORUS STEM; DIGITALIS; NITROGLYCERIN; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 3; 4; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0160_91bfe43e-e6e1-4713-a26e-fa565da697ef 43857-0160 HUMAN OTC DRUG Injury Arnica Montana, Calendula Officinalis, Symphytum Officinalis, Hypericum Perforatum, Belladonna, Bellis Perennis, Carbo Vegetabilis, Hamamelis Virginiana, Millefolium, Rhus Tox, Ruta Graveolens, Veratrum Album LIQUID ORAL 20130417 20210113 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY LEAF; HYPERICUM PERFORATUM; ATROPA BELLADONNA WHOLE; BELLIS PERENNIS; ACTIVATED CHARCOAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACHILLEA MILLEFOLIUM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; VERATRUM ALBUM ROOT 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0161_6c128790-08ca-418e-a2c8-e6fda37a620f 43857-0161 HUMAN OTC DRUG Norepinephrine Norepinephrine LIQUID ORAL 20130417 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. NOREPINEPHRINE 6 [hp_X]/mL N 20181231 43857-0162_56db4ff7-8814-49ff-9b6d-312098693cb4 43857-0162 HUMAN OTC DRUG Radiation Capsicum Annuum, Cetraria Islandica, Fucus Vesiculosus, Glandula Suprarenalis Suis, Thyroidinum (Suis), Cadmium Iodatum, Hydrangea Arborescens, Phosphoricum Acidum, Phosphorus, Pulsatilla (Vulgaris), Strontium Carbonicum, Uranium Nitricum, X-Ray LIQUID ORAL 20121105 UNAPPROVED HOMEOPATHIC BioActive Nutritional CAPSICUM; CETRARIA ISLANDICA SUBSP. ISLANDICA; FUCUS VESICULOSUS; SUS SCROFA ADRENAL GLAND; THYROID, PORCINE; CADMIUM IODIDE; HYDRANGEA ARBORESCENS ROOT; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; STRONTIUM CARBONATE; URANYL NITRATE HEXAHYDRATE; ALCOHOL, X-RAY EXPOSED (1000 RAD) 3; 3; 3; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0163_afc2f9b2-2f43-4ed8-b8dc-93fc6756fa5e 43857-0163 HUMAN OTC DRUG Intestaforce Althaea Officinalis, Capsicum Annuum, Foeniculum Vulgare, Symphytum Officinale, Argentum Nitricum, Ferrum Phosphoricum, Magnesia Phosphorica, Mercurius Solubilis LIQUID ORAL 20130417 20210114 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALTHAEA OFFICINALIS ROOT; CAPSICUM; FENNEL SEED; COMFREY ROOT; SILVER NITRATE; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS 3; 3; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0164_9b7ff634-0c8f-4107-af04-80f9afe98b2a 43857-0164 HUMAN OTC DRUG Circulatone Fagopyrum Esculentum, Magnesia Muriatica, Citrus Bioflavonoids, Heart (Suis), Thyroidinum (Suis), Arsenicum Iodatum, Aurum Muriaticum, Baryta Muriatica, Calcarea Iodata, Cholesterinum, Conium Maculatum, Kali Iodatum, Plumbum Metallicum, Arnica Montana, Phosphorus LIQUID ORAL 20130422 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. FAGOPYRUM ESCULENTUM; MAGNESIUM CHLORIDE; CITRUS BIOFLAVONOIDS; PORK HEART; SUS SCROFA THYROID; ARSENIC TRIIODIDE; GOLD TRICHLORIDE; BARIUM CHLORIDE DIHYDRATE; CALCIUM IODIDE; CHOLESTEROL; CONIUM MACULATUM FLOWERING TOP; POTASSIUM IODIDE; LEAD; ARNICA MONTANA; PHOSPHORUS 3; 3; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0165_8dfc618a-54e7-460c-88b8-e1b1b34c5d59 43857-0165 HUMAN OTC DRUG Gynetox Angelica Archangelica, Cimicifuga Racemosa, Zincum Gluconicum, Funiculus Umbilicalis Suis, Lymph Node (Suis), Oophorinum (Suis), Uterus (Suis), Glandula Suprarenalis Suis, Thyroidinum Suis, Boricum Acidum, Kreosotum, Mercurius Solubilis, Pulsatilla, Sepia, Calcarea Carbonica, Phosphorus, Sabina, Candida Albicans, Herpes Simplex 1 And 2 Nosode, Human Papilloma Virus Nosode LIQUID ORAL 20140903 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; ZINC GLUCONATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA LYMPH; SUS SCROFA OVARY; SUS SCROFA UTERUS; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYROID; BORIC ACID; WOOD CREOSOTE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; JUNIPERUS SABINA LEAFY TWIG; CANDIDA ALBICANS; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN PAPILLOMAVIRUS 3; 3; 6; 8; 8; 8; 8; 9; 9; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0166_856f35fd-d411-41d5-9a29-a636c9928168 43857-0166 HUMAN OTC DRUG Immune Forte Dehydroepiandrosterone (DHEA), Estradiol, Hypophysis Suis, Pregnenolone, Progesterone, Spleen (Bovine), Testosterone, Thymus (Suis), Thyroidinum (Suis) LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PRASTERONE; ESTRADIOL; SUS SCROFA PITUITARY GLAND; PREGNENOLONE; PROGESTERONE; BOS TAURUS SPLEEN; TESTOSTERONE; SUS SCROFA THYMUS; THYROID, PORCINE 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0167_310b404f-ad76-4164-91f6-c899a271e8b7 43857-0167 HUMAN OTC DRUG Oligo Bio Iodine Chelidonium Majus, Spongia Tosta, Iodium, Lycopus Virginicus, Ginkgo Biloba, Pinus Sylvestris, Fucus Vesiculosus, Germanium Sesquioxide, Pituitaria Glandula (Suis), Thyroidinum (Suis), Cysteinum, Manganese Gluconate, Alpha-Ketoglutaricum acidum, Calcarea Carbonica, Ferrum Iodatum, Natrum Oxalaceticum, Pulsatilla, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Eugenol, Formalinum, Lidocaine, Mercurius Solubilis, Molybdenum Metallicum, Niccolum Metallicum, Palladium Metallicum, LIQUID ORAL 20130812 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; SPONGIA OFFICINALIS SKELETON, ROASTED; IODINE; LYCOPUS VIRGINICUS; GINKGO; PINUS SYLVESTRIS LEAFY TWIG; FUCUS VESICULOSUS; GERMANIUM SESQUIOXIDE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; CYSTEINE; MANGANESE GLUCONATE; .ALPHA.-KETOGLUTARIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; FUMARIC ACID; POTASSIUM IODIDE; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; SILVER; GOLD; COPPER; EUGENOL; FORMALDEHYDE; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; TIN; TITANIUM; ZINC; MUMPS VIRUS; RUBELLA VIRUS; HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B3; HUMAN COXSACKIEVIRUS B4 3; 3; 4; 4; 6; 6; 6; 8; 8; 8; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 16; 16; 16; 16; 16 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0168_4af75847-5944-45b7-95d6-efa3369c29ab 43857-0168 HUMAN OTC DRUG Food Additives Berberis Vulgaris, Chelidonium Majus, Trifolium Pratense, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Rhamnus Purshiana, Stillingia Sylvatica, Xanthoxylum Fraxineum, Arsenicum Album, Belladonna, Lycopodium Clavatum, Natrum Sulphuricum, Phosphoricum Acidum LIQUID ORAL 20130516 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; TRIFOLIUM PRATENSE FLOWER; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; STILLINGIA SYLVATICA ROOT; ZANTHOXYLUM AMERICANUM BARK; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; PHOSPHORIC ACID 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0169_f72fbe67-cbed-42e4-90e9-de37568751a7 43857-0169 HUMAN OTC DRUG Tobaccotox Avena Sativa, Kali Phosphoricum, Cactus Grandiflorus, Daphne Indica, Eucalyptol, Lobelia Inflata, Mentholum, Ignatia Amara, Nux Vomica, Staphysagria, Tabacum, Benzinum, Naphthalinum LIQUID ORAL 20130604 20200302 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AVENA SATIVA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SELENICEREUS GRANDIFLORUS STEM; DAPHNE ODORA BARK; EUCALYPTOL; LOBELIA INFLATA; MENTHOL; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF; BENZENE; NAPHTHALENE 1; 2; 3; 3; 3; 3; 3; 12; 12; 12; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0170_7c5ffea3-9b73-4135-9f56-02d633b05088 43857-0170 HUMAN OTC DRUG Cystoforce Sarsaparilla, Solidago Virgaurea, Uva Ursi, Apis Mellifica, Arsenicum Album, Cantharis, Hepar Sulphuris Calcareum LIQUID ORAL 20130605 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SMILAX REGELII ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; APIS MELLIFERA; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CALCIUM SULFIDE 3; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0171_ef3fa1f6-a7ec-4fba-b593-57df454867d0 43857-0171 HUMAN OTC DRUG Bio Argimony Agrimonia Eupatoria, Flos (Agrimony) LIQUID ORAL 20140826 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AGRIMONIA EUPATORIA FLOWER 6 [hp_X]/mL N 20181231 43857-0172_a38f0abb-4b64-4120-bd4f-08cae1f2ec47 43857-0172 HUMAN OTC DRUG Diathesis V 1 Ginkgo Biloba, Pancreas (Suis), Spleen (Suis), Stomach (Suis), Germanium Sesquioxide, Cuprum Metallicum, Cysteinum, Zincum Metallicum, Manganese Gluconate, Alpha-Ketoglutaricum Acidum, Fumaricum Acidum, Natrum Oxalaceticum LIQUID ORAL 20130516 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. GINKGO; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; GERMANIUM SESQUIOXIDE; COPPER; CYSTEINE; ZINC; MANGANESE GLUCONATE; .ALPHA.-KETOGLUTARIC ACID; FUMARIC ACID; SODIUM DIETHYL OXALACETATE 6; 6; 6; 6; 8; 9; 9; 9; 10; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0173_78c82e55-0fa8-4c92-9df1-f1c93109530b 43857-0173 HUMAN OTC DRUG TREE ANTIGEN American Beech, American Elm, Black Walnut, Black Willow, Negundo, Eastern Cottonwood, Hickory, Red Birch, Red Oak, Platanus, Fraxinus Americana, Melaleuca Blossom, Arsenicum Album, Lycopodium Clavatum, Pulsatilla Vulgaris LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. FAGUS GRANDIFOLIA POLLEN; ULMUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; CARYA OVATA POLLEN; BETULA OCCIDENTALIS POLLEN; QUERCUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; FRAXINUS AMERICANA POLLEN; MELALEUCA ALTERNIFOLIA FLOWERING TOP; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0174_4ff949ed-cc43-4502-bec8-eddcd3ebc60e 43857-0174 HUMAN OTC DRUG Bronci HP Carbo Vegetabilis, Cuprum Metallicum, Drosera (Rotundifolia), Ipecacuanha, Lachesis Mutus, Lobelia Inflata, Phosphorus, Pulsatilla (Vulgaris), Rumex Crispus, Spongia Tosta LIQUID ORAL 20130611 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACTIVATED CHARCOAL; COPPER; DROSERA ROTUNDIFOLIA; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0176_a42075b1-fa82-486b-9ec4-a0882c1fc1fe 43857-0176 HUMAN OTC DRUG Cerebroforce Capsicum Annuum, Ginkgo Biloba, Gelsemium Sempervirens, Kali Phosphoricum, Lycopodium Clavatum, Phosphorus, Arsenicum Album LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc CAPSICUM; GINKGO; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; ARSENIC TRIOXIDE 3; 3; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0177_0b1fd8a7-b47c-4705-b7d0-8b85476dd92e 43857-0177 HUMAN OTC DRUG Candida Candida Albicans LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 12 [hp_X]/mL N 20181231 43857-0178_edc0a842-5b2e-44de-9686-5d0bd0f28680 43857-0178 HUMAN OTC DRUG Bio Elm Ulmus Procera, Flos LIQUID ORAL 20130611 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ULMUS PROCERA FLOWERING TWIG 6 [hp_X]/mL N 20191231 43857-0179_0474528f-20ee-4ac4-85fa-92ce2e66f0a7 43857-0179 HUMAN OTC DRUG Bac HP Apis Mellifica, Arsenicum Album, Belladonna, Chamomilla, Lachesis Mutus, Mercurius Solubilis, Pulsatilla, Rhus Toxicodendron, Silicea LIQUID ORAL 20140826 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0180_7f1d2630-da6f-4320-aab3-774bf3c78eeb 43857-0180 HUMAN OTC DRUG FEMALE BALANCE Folliculinum, Progesterone LIQUID ORAL 20130801 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ESTRONE; PROGESTERONE 6; 6 [hp_X]/mL; [hp_X]/mL N 20181231 43857-0181_ef38de93-94f1-4f9a-a9bf-caecbd77b274 43857-0181 HUMAN OTC DRUG Hypert HP Arnica Montana, Aurum Metallicum, Cactus Grandiflorus, Calcarea Carbonica, Natrum Muriaticum, Nux Vomica, Phosphorus, Solidago Virgaurea LIQUID ORAL 20130612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; GOLD; SELENICEREUS GRANDIFLORUS STEM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SOLIDAGO VIRGAUREA FLOWERING TOP 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0182_64fbb371-c22d-472b-8595-f5f96ffe4307 43857-0182 HUMAN OTC DRUG Bio Wild Oat Bromus Ramosus, Flos LIQUID ORAL 20130612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BROMUS RAMOSUS FLOWER 6 [hp_X]/mL N 20181231 43857-0183_9412044f-f6c6-4206-a26f-90f44ed9d232 43857-0183 HUMAN OTC DRUG Bio Centaury Centaurium Umbellatum, Flos LIQUID ORAL 20130613 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CENTAURIUM ERYTHRAEA 6 [hp_X]/mL N 20181231 43857-0184_c3bb6040-8b39-4fe6-b5dc-50f2efee6b0c 43857-0184 HUMAN OTC DRUG Candida Alb Candida Albicans LIQUID ORAL 20130612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 500 [hp_X]/mL N 20181231 43857-0185_330f69bb-17d7-4646-af3e-6916c3d63a0e 43857-0185 HUMAN OTC DRUG Candida Alb Candida Albicans LIQUID ORAL 20130612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 12 [hp_X]/mL N 20181231 43857-0186_a5b4d93d-7865-48c5-a179-8bd42ad1a093 43857-0186 HUMAN OTC DRUG Gastrotone Capsicum Annuum, Foeniculum Vulgare, Symphytum Officinale, Argentum Nitricum, Arsenicum Album, Magnesia Phosphorica LIQUID ORAL 20130612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CAPSICUM; FENNEL SEED; COMFREY ROOT; SILVER NITRATE; ARSENIC TRIOXIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS 3; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0187_1cc46acd-4c59-4f83-80f5-09fbbe42d509 43857-0187 HUMAN OTC DRUG Neurotone Passiflora Incarnata, Glandula Suprarenalis Suis, Thyroidinum (Suis), Arnica Montana, Hypericum Perforatum, Lachesis Mutus, Muira Puama LIQUID ORAL 20130611 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PASSIFLORA INCARNATA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYROID; ARNICA MONTANA; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; PTYCHOPETALUM OLACOIDES ROOT 3; 8; 8; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0188_73b181d1-820c-455b-a391-1177c2be3449 43857-0188 HUMAN OTC DRUG ASTH-HP Arsenicum Album, Belladonna, Ipecacuanha, Kali Carbonicum, Lobelia Inflata, Natrum Sulphuricum, Silicea LIQUID ORAL 20130806 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; IPECAC; POTASSIUM CARBONATE; LOBELIA INFLATA; SODIUM SULFATE; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0189_3bcf5b8a-26a0-46d8-9834-ffb87ed569c3 43857-0189 HUMAN OTC DRUG BIO BEECH Beech LIQUID ORAL 20130806 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. FAGUS SYLVATICA FLOWERING TOP 6 [hp_X]/mL N 20181231 43857-0190_86992350-f0f7-47f2-af6c-40a0955e176c 43857-0190 HUMAN OTC DRUG PNEUMOPLEX Plantago Major, Arsenicum Album, Lung (Bovine), Symphytum Officinale, Silicea, Phellandrium Aquaticum, Phosphorus, Sulphur LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PLANTAGO MAJOR; ARSENIC TRIOXIDE; BEEF LUNG; COMFREY ROOT; SILICON DIOXIDE; OENANTHE AQUATICA FRUIT; PHOSPHORUS; SULFUR 3; 6; 6; 6; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0191_bf21b9cf-bd56-4e83-a552-1ed18fb9137b 43857-0191 HUMAN OTC DRUG NEUROFORCE Echinacea, Hypericum Perforatum, Symphytum Officinale, Arnica Montana, Agaricus Muscarius, Arsenicum Album, Gelsemium Sempervirens, Plumbum Metallicum, Rhus tox, LIQUID ORAL 20130801 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; COMFREY ROOT; ARNICA MONTANA; AMANITA MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; GELSEMIUM SEMPERVIRENS ROOT; LEAD; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0192_ebb1bf51-71ff-43c9-98c2-709aad162c5d 43857-0192 HUMAN OTC DRUG EAR Baptisia Tinctoria, Echincea, Hydrastis Canadensis, Phytolacca Decandra, Capsicum Annuum, Chamomilla, Ferrum Phosphoricum, Kali Muriaticum, Plantago Major, Pulsatilla LIQUID ORAL 20130730 20180820 UNAPPROVED HOMEOPATHIC BioActive Nutrional, Inc BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; CAPSICUM; MATRICARIA RECUTITA; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS 3; 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0193_6aff8dcc-ba06-4474-b525-0e976d0770f0 43857-0193 HUMAN OTC DRUG NEUROTOX Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Gelsemium Sempervirens, Latrodectus Mactans, Rhus Toxicodendron, Tarentula Cubensis, Salmonalla Typhi, Clostridium Perfringens, Alluminum Metallicum, Antimonium Crudum, Artentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium Metallicum, Cobaltum Metallicum, Cuprum Metallicum, LIQUID ORAL 20140725 20181218 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMANITA MUSCARIA FRUITING BODY; PROTORTONIA CACTI; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; GELSEMIUM SEMPERVIRENS ROOT; LATRODECTUS MACTANS; TOXICODENDRON PUBESCENS LEAF; CITHARACANTHUS SPINICRUS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; CLOSTRIDIUM PERFRINGENS; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; IRIDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANIUM; VANADIUM; YTTERBIUM OXIDE; ZINC; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE; MEASLES VIRUS; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); HUMAN HERPESVIRUS 4; POLIOVIRUS; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA 12; 12; 12; 12; 12; 30; 30; 30; 30; 33; 15; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0194_4987a0a7-eed4-4143-a8d3-62e3a44deb17 43857-0194 HUMAN OTC DRUG THYMUS Thymus (Suis) LIQUID ORAL 20130809 UNAPPROVED HOMEOPATHIC BioActive Nutrional, Inc. SUS SCROFA THYMUS 8 [hp_X]/mL N 20181231 43857-0195_802736ff-b724-468d-9513-d27e7a363ac1 43857-0195 HUMAN OTC DRUG Flu Tonic Echinacea, Uva-Ursi, Baptisia Tinctoria, Convallaria Majalis, Kali Muriaticum, Pinus Sylvetris, Thuja Occidentalis, Bryonia, Condurango, Crotalus Horridus, Ginkgo Biloba, Lachesis Mutus, Selenium Metallicum, Tabebuia Impetiginosa, Viscum Album LIQUID ORAL 20130910 20180928 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA, UNSPECIFIED; ARCTOSTAPHYLOS UVA-URSI LEAF; BAPTISIA TINCTORIA; CONVALLARIA MAJALIS; POTASSIUM CHLORIDE; PINUS SYLVESTRIS LEAFY TWIG; THUJA OCCIDENTALIS LEAF; BRYONIA ALBA ROOT; MARSDENIA CONDURANGO BARK; CROTALUS HORRIDUS HORRIDUS VENOM; GINKGO; LACHESIS MUTA VENOM; SELENIUM; TABEBUIA IMPETIGINOSA BARK; VISCUM ALBUM FRUITING TOP 1; 1; 3; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0196_156655ec-f374-42e7-811a-3a54a3d5346c 43857-0196 HUMAN OTC DRUG Throat Formula Baptisia Tinctoria, Phytolacca Decandra, Apis Mellifica, Belladonna, Lachesis Mutus, Mercurius Solubilis, Hepar Sulphuris Calcareum SPRAY ORAL 20130813 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA; PHYTOLACCA AMERICANA ROOT; APIS MELLIFERA; ATROPA BELLADONNA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; CALCIUM SULFIDE 3; 3; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0197_78ef4be3-b8a3-4154-9bbf-ce080e1a9a41 43857-0197 HUMAN OTC DRUG Renotox Triticum Aestivum, Asparagus Officinalis, Barosma (Betulina), Berberis Vulgaris, Echinacea, Kali Muriaticum, Petroselinum Sativum, Sabal Serrulata, Solidago Virgaurea, Taraxacum Officinale, Uva-Ursi, Eupatorium Purpureum, Kidney (Suis), Bryonia (Alba), Mercurius Corrosivus, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum LIQUID ORAL 20140728 20190121 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRITICUM AESTIVUM WHOLE; ASPARAGUS; AGATHOSMA BETULINA LEAF; BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; POTASSIUM CHLORIDE; PETROSELINUM CRISPUM; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF; EUPATORIUM PURPUREUM ROOT; PORK KIDNEY; BRYONIA ALBA ROOT; MERCURIC CHLORIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; CLOSTRIDIUM PERFRINGENS; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; IRIDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; MEASLES VIRUS; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); HUMAN HERPESVIRUS 4; POLIOVIRUS; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA 1; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 12; 12; 33; 15; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0198_fcd64d78-a07b-40de-a731-d5a822c68b55 43857-0198 HUMAN OTC DRUG Hydrate I Coffea Tosta, Ginkgo Biloba, Germanium Sesquioxide, Silicea LIQUID ORAL 20130911 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. COFFEA ARABICA SEED, ROASTED; GINKGO; GERMANIUM SESQUIOXIDE; SILICON DIOXIDE 1; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0199_5e7aebc7-dca2-4af0-9f75-c47652e3362a 43857-0199 HUMAN OTC DRUG Virotox Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Glandula Suprarenalis Bovine, Thymus (Bovine), Belladonna, Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Pyrogenium, LIQUID ORAL 20130815 20190317 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA, UNSPECIFIED; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM AQUATICUM; TABEBUIA IMPETIGINOSA BARK; BOS TAURUS ADRENAL GLAND; BOS TAURUS THYMUS; ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; RANCID BEEF 3; 3; 3; 3; 3; 3; 8; 8; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0200_5432620b-ef2c-4e7b-8398-a9db9de9d538 43857-0200 HUMAN OTC DRUG Bac GD Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Propolis, Tabebuia Impetiginosa, Glandula Suprarenalis, Lymph, Spleen, LIQUID ORAL 20140122 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA, UNSPECIFIED; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM AQUATICUM; PROPOLIS WAX; TABEBUIA IMPETIGINOSA BARK; BOS TAURUS ADRENAL GLAND; SUS SCROFA LYMPH; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; SUS SCROFA THYROID; ARSENIC TRIOXIDE; ATROPA BELLADONNA; HYPERICUM PERFORATUM; PHOSPHORUS; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; CLOSTRIDIUM PERFRINGENS; AMOEBA PROTEUS 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12; 30; 30; 30; 30; 30; 33; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0201_26fef16d-cad1-4003-9bda-dd47756a5347 43857-0201 HUMAN OTC DRUG VERTIFORCE Leonurus Cardiaca, Agaricus Muscarius, Arsenicum Album, Cocculus Indicus, Conium Maculatum, Petroleum, Phosphorus, Pulsatilla, Tabacum, Theridion LIQUID ORAL 20130812 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. LEONURUS CARDIACA; AMANITA MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; KEROSENE; PHOSPHORUS; PULSATILLA VULGARIS; TOBACCO LEAF; THERIDION CURASSAVICUM 3; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0202_26c7e72a-1e79-409b-922e-eb96f1e801ce 43857-0202 HUMAN OTC DRUG Grippe HP Aconitum Napellus, Arsenicum Album, Belladonna, Bryonia, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens LIQUID ORAL 20130911 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0203_6951631d-2627-410f-b803-8b5d7e116f1e 43857-0203 HUMAN OTC DRUG Menopause HP Belladonna, Lachesis Mutus, Nux Vomica, Pulsatilla (Vulgaris), Secale Cornutum, Sepia, Ustilago Maidis LIQUID ORAL 20130911 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; LACHESIS MUTA VENOM; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; USTILAGO MAYDIS 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0204_a70dd768-5ce2-4821-9cdf-f4ec73ba9730 43857-0204 HUMAN OTC DRUG Ovaplex Angelica Archangelica, Caulophyllum Thalictroides, Dioscorea Villosa, Hypophysis Suis, Oophorinum (Suis) Thyroidinum (Suis), Uterus (Suis), Zincum Gluconicum, Apis Mellifica, Belladonna, Cimicifuga Racemosa, Magnesia Phosphorica, Sepia LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANGELICA ARCHANGELICA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; DIOSCOREA VILLOSA TUBER; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; SUS SCROFA UTERUS; ZINC GLUCONATE; APIS MELLIFERA; ATROPA BELLADONNA; BLACK COHOSH; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE 3; 3; 3; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0205_c1f990cb-c09c-4f1c-b2ba-0231b0eaaaa4 43857-0205 HUMAN OTC DRUG Parathyroplex Parathyroid Gland (Bovine), Baryta Carbonica, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Cuprum Metallicum, Magnesia Phosphorica, Manganum Metallicum, Rhus Tox, Silicea LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BOS TAURUS PARATHYROID GLAND; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM FLUORIDE; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 6; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0206_f7ded984-f5d1-4242-a2b2-b2984b83bcfe 43857-0206 HUMAN OTC DRUG Rhustoxoforce Apis Mellifica, Cantharis, Graphites, Natrum Muriaticum, Rhus Glabra, Rhus Toxicodendron, Rhus Venenata, Urtica Dioica LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; LYTTA VESICATORIA; GRAPHITE; SODIUM CHLORIDE; RHUS GLABRA TOP; TOXICODENDRON PUBESCENS LEAF; TOXICODENDRON VERNIX LEAFY TWIG; URTICA DIOICA 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0207_87c4fb32-b88d-421b-b2f3-482bcf74a465 43857-0207 HUMAN OTC DRUG Septaforce Baptisia Tinctoria, Echinacea, Arsenicum Album, Chininum Sulphuricum, Crotalus Horridus, Lachesis Mutus, Loxosceles Reclusa LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; ARSENIC TRIOXIDE; QUININE SULFATE; CROTALUS HORRIDUS HORRIDUS VENOM; LACHESIS MUTA VENOM; LOXOSCELES RECLUSA; CLAVICEPS PURPUREA SCLEROTIUM; CITHARACANTHUS SPINICRUS; LATRODECTUS MACTANS; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0208_29abd755-83b9-45de-b0cd-0005104f9060 43857-0208 HUMAN OTC DRUG Oligo Bio Iodine Chelidonium Majus, Spongia Tosta, Iodium, Lycopus Virginicus, Ginkgo Biloba, Pinus Sylvestris, Fucus Vesiculosus, Germanium Sesquioxide, Pituitaria Glandula, Thyroidinum, Cysteinum, Manganese Gluconate, LIQUID ORAL 20131021 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; SPONGIA OFFICINALIS SKELETON, ROASTED; IODINE; LYCOPUS VIRGINICUS; GINKGO; PINUS SYLVESTRIS LEAFY TWIG; FUCUS VESICULOSUS; GERMANIUM SESQUIOXIDE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; CYSTEINE; MANGANESE GLUCONATE; .ALPHA.-KETOGLUTARIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; FUMARIC ACID; POTASSIUM IODIDE; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; SILVER; GOLD; COPPER; EUGENOL; FORMALDEHYDE; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; TIN; TITANIUM; ZINC; MUMPS VIRUS; RUBELLA VIRUS; HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B3; HUMAN COXSACKIEVIRUS B4 3; 3; 4; 4; 6; 6; 6; 8; 8; 8; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 16; 16; 16; 16; 16 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0209_8f207931-e279-4a29-8b0c-991c1cc10fe7 43857-0209 HUMAN OTC DRUG Cerebraplex Avena Sativa, Capsicum Annuum, Ginkgo Biloba, Hydrocotyle Asiatica, Polygonum Multiflorum, Rosmarinus Officinalis, Vinca Minor, Brain (Suis), Baryta Carbonica, Belladonna, Germanium Sesquioxide, Kali Phosphoricum, Stramonium LIQUID ORAL 20130821 20200403 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AVENA SATIVA FLOWERING TOP; CAPSICUM; GINKGO; CENTELLA ASIATICA; FALLOPIA MULTIFLORA ROOT; ROSMARINUS OFFICINALIS FLOWERING TOP; VINCA MINOR; PORK BRAIN; BARIUM CARBONATE; ATROPA BELLADONNA; GERMANIUM SESQUIOXIDE; POTASSIUM PHOSPHATE, DIBASIC; DATURA STRAMONIUM 3; 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0210_b3d6c156-af6c-4db7-a5ac-ccff0bc45d16 43857-0210 HUMAN OTC DRUG Endoplex F Cimicifuga Racemosa, Fucus Vesiculosus, Glycyrrhiza Glabra, Xanthoxylum Fraxineum, Adrenalinum, Brain (Suis), Hypothalamus (Suis), Oophorinum (Suis), Pineal (Suis), Pituitaria Glandula (Suis), Thyroidinum (Suis), Pulsatilla, Sepia LIQUID ORAL 20130821 20190708 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BLACK COHOSH; FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; ZANTHOXYLUM AMERICANUM BARK; EPINEPHRINE; PORK BRAIN; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 3; 3; 3; 3; 8; 8; 8; 8; 8; 8; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0211_9ae7e45b-ee90-4e21-a438-caddfd36fab1 43857-0211 HUMAN OTC DRUG BAC Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Propolis, Glandula Suprarenalis Suis, Lymph Node (Suis), Spleen (Suis), Thymus (Suis), Thyroidinum (Suis), Arsenicum Album, Belladonna, Hypericum Perforatum, Phosphorus, Botulinum, Escherichia Coli, Proteus (Vulgaris), Pseudomonas Aeruginosa, Yersinia Enterocolitica, Salmonella Typhi Nosode, Clostridium Perfringens LIQUID ORAL 20140617 20210502 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; THYROID, PORCINE; ARSENIC ACID; ATROPA BELLADONNA; HYPERICUM PERFORATUM; PHOSPHORUS; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; CLOSTRIDIUM PERFRINGENS 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12; 30; 30; 30; 30; 30; 33; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0212_464a262b-9c74-4c45-ad00-fb83cfc3c65d 43857-0212 HUMAN OTC DRUG Venoforce II Collinsonia Canadensis, Hamamelis Virginiana, Aesculus Hippocastanum, Belladonna, Calcarea Fluorica, Carduus Marianus, Pulsatilla, Secale Cornutum, Vipera Berus LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; ATROPA BELLADONNA; CALCIUM FLUORIDE; SILYBUM MARIANUM SEED; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM; VIPERA BERUS VENOM 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0213_becaaf29-a0a8-4d09-96e9-532867121a91 43857-0213 HUMAN OTC DRUG Pneumo HP Ammonium Muriaticum, Antimonium Tartaricum, Arsenicum Album, Calcarea Carbonica, Lobelia Inflata, Natrum Sulphuricum, Spongia Tosta, Phosphorus, LIQUID ORAL 20140122 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMMONIUM CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LOBELIA INFLATA; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0214_29ab1f89-b009-46ca-b6cf-84b0122edd8e 43857-0214 HUMAN OTC DRUG Influaforce Plus Bryonia (Alba), Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Kreosotum, Veratrum Viride, Avian Flu Virus Nosode LIQUID ORAL 20141002 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; WOOD CREOSOTE; VERATRUM VIRIDE ROOT; INFLUENZA A VIRUS A/VIETNAM/1203/2004 (H5N1, CLADE 1) ANTIGEN (FORMALDEHYDE INACTIVATED) 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0215_9264226a-7b20-43f1-8f9b-65b03f983ad0 43857-0215 HUMAN OTC DRUG Arterioforce II Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Phytolacca Decandra, Myrrha, Nasturtium Aquaticum, Trigonella Foenum-graecum, Kali Iodatum, Arnica Montana, Cactus Grandiflorus, Propolis, Baryta Carbonica, Conium Maculatum, Secale Cornutum, LIQUID ORAL 20130910 20180319 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; MYRRH; NASTURTIUM AQUATICUM; FENUGREEK SEED; POTASSIUM IODIDE; ARNICA MONTANA; SELENICEREUS GRANDIFLORUS STEM; PROPOLIS WAX; BARIUM CARBONATE; CONIUM MACULATUM FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM 3; 3; 3; 3; 4; 4; 4; 5; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0216_29c1e78d-af27-48e1-8897-149909898f2e 43857-0216 HUMAN OTC DRUG Depressoforce Picricum acidum, Arsenicum album, Aurum metallicum, Ignatia amara, Natrum muriaticum, Nitricum acidum, Pulsatilla (Vulgaris), Sepia, LIQUID ORAL 20140616 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PICRIC ACID; ARSENIC TRIOXIDE; GOLD; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; NITRIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 12; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0217_99a44b58-29e7-4016-ba9a-d883823a0589 43857-0217 HUMAN OTC DRUG Enuresis Equisetum Hyemale, Solidago Virgaurea, Uva-Ursi, Argentum Metallicum, Causticum, Kreosotum, Nitricum Acidum, Sepia, Thuja Occidentalis LIQUID ORAL 20150401 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. EQUISETUM HYEMALE; SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; SILVER; CAUSTICUM; WOOD CREOSOTE; NITRIC ACID; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0218_190e45f2-2db3-4be7-af16-ec33607fbfdd 43857-0218 HUMAN OTC DRUG Interferon Interferon (Suis) LIQUID ORAL 20130923 UNAPPROVED HOMEOPATHIC BioActive Nutritional INTERFERON .GAMMA. PORCINE RECOMBINANT 6 [hp_C]/mL N 20181231 43857-0219_94eceeac-bc5b-4761-81f4-7cf6d584634e 43857-0219 HUMAN OTC DRUG Bio Aspen Aspen LIQUID ORAL 20130830 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. POPULUS TREMULA FLOWERING TOP 6 [hp_X]/mL N 20181231 43857-0220_0d3ba25b-7a1b-4b42-b617-949b32844699 43857-0220 HUMAN OTC DRUG Bio Rock Water Rock Water LIQUID ORAL 20130829 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. WATER 6 [hp_X]/mL N 20181231 43857-0221_bf134eb5-91ad-42b4-a4ad-6e8478399b9d 43857-0221 HUMAN OTC DRUG NV-HP Arsenicum Album, Cocculus Indicus, Ipecacuanha, Kerosotum, Petroleum, Pulsatilla, Sanguinaria Canadensis, Tabacum LIQUID ORAL 20130917 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; ANAMIRTA COCCULUS SEED; IPECAC; WOOD CREOSOTE; LIQUID PETROLEUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; TOBACCO LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0222_1b18593b-09b2-47b1-9e44-f75ad5fb3933 43857-0222 HUMAN OTC DRUG Animal Antigens Canary Feathers, Cat Hair, Cattle Epithelia, Chicken Feathers, Dog Epithelia, Duck Feathers, Gerbil Epithelia, Goat Epithelia, Goose Feathers LIQUID ORAL 20130919 UNAPPROVED HOMEOPATHIC BioActive Nutritional SERINUS CANARIA FEATHER; FELIS CATUS HAIR; BOS TAURUS SKIN; GALLUS GALLUS FEATHER; CANIS LUPUS FAMILIARIS SKIN; ANAS PLATYRHYNCHOS FEATHER; MERIONES UNGUICULATUS SKIN; CAPRA HIRCUS SKIN; ANSER ANSER FEATHER; CAVIA PORCELLUS SKIN; MESOCRICETUS AURATUS SKIN; SUS SCROFA SKIN; EQUUS CABALLUS SKIN; MUS MUSCULUS SKIN; MELOPSITTACUS UNDULATUS FEATHER; ORYCTOLAGUS CUNICULUS SKIN; RATTUS NORVEGICUS SKIN; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0223_f67360e1-df4f-4eb3-a4d5-47c6cc330948 43857-0223 HUMAN OTC DRUG Dairy Antigens American Cheese, Blue Cheese, Brie Cheese, Cheddar Cheese, Cottage Cheese, Swiss Cheese, Lac Vaccinum, Goat Milk LIQUID ORAL 20130920 UNAPPROVED HOMEOPATHIC BioActive Nutritional WHEY; CALCIUM PHOSPHATE, UNSPECIFIED FORM; SODIUM CITRATE, UNSPECIFIED FORM; SODIUM CHLORIDE; SODIUM PHOSPHATE; SORBIC ACID; CITRIC ACID MONOHYDRATE; APOCAROTENAL; .BETA.-CAROTENE; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED; CASEIN, EMMENTAL CULTURED; COW MILK; GOAT MILK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SKIM MILK; SEPIA OFFICINALIS JUICE; SULFUR 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0224_efde31a8-2068-47dc-a754-0531ea093aa9 43857-0224 HUMAN OTC DRUG Prostatone HP Clematis Erecta, Conium Maculatum, Lycopodium Clavatum, Mercurius Corrosivus, Pulsatilla Vulgaris, Sabal Serrulata, Selenium Metallicum, Sepia, Staphysagria, Thuja Occidentalis LIQUID ORAL 20130920 20190702 UNAPPROVED HOMEOPATHIC BioActive Nutritional CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0225_2783c70e-60fc-44fa-8e2c-049856b45c6b 43857-0225 HUMAN OTC DRUG Household Antigens Acetonum, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Anacardium Orientale, Graphites, Nitricum Acidum, Pulsatilla (Vulgaris), Sulphur LIQUID ORAL 20130918 UNAPPROVED HOMEOPATHIC BioActive Nutritional ACETONE; SODIUM TRIPOLYPHOSPHATE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; AMMONIUM CHLORIDE; SODIUM LAURYL SULFATE; TURPENTINE OIL; SEMECARPUS ANACARDIUM JUICE; GRAPHITE; NITRIC ACID; PULSATILLA VULGARIS; SULFUR 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0226_37e29af7-2896-47d1-8f2e-d9ccd03108d6 43857-0226 HUMAN OTC DRUG L-Dopa L-Dopa LIQUID ORAL 20150327 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. LEVODOPA 6 [hp_X]/mL N 20181231 43857-0227_842929a8-8e58-4c45-89c9-56d39127ac8e 43857-0227 HUMAN OTC DRUG Colloidal Silver Colloidal Silver LIQUID ORAL 20150401 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SILVER 6 [hp_X]/mL N 20181231 43857-0229_242ee500-e8a9-4f8d-aebc-97d9e052aad2 43857-0229 HUMAN OTC DRUG Taurine Taurine LIQUID ORAL 20130923 UNAPPROVED HOMEOPATHIC BioActive Nutritional TAURINE 6 [hp_X]/mL N 20181231 43857-0230_eb23a6bf-6e2f-4cfb-904c-675334dd8034 43857-0230 HUMAN OTC DRUG Cryptotox Combo Crotalus Horridus, Naja Tripudians, Oxyuranus Scutellatus Canni, Cenchris Contortrix LIQUID ORAL 20130923 UNAPPROVED HOMEOPATHIC BioActive Nutritional CROTALUS HORRIDUS HORRIDUS VENOM; NAJA NAJA VENOM; CROTALUS DURISSUS TERRIFICUS VENOM; OXYURANUS SCUTELLATUS CANNI VENOM; AGKISTRODON CONTORTRIX VENOM 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0231_c15fc262-73ed-49dd-b340-0af171aec314 43857-0231 HUMAN OTC DRUG Hepataforce Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Lycopodium Clavatum, Magnesia Phosphorica, Natrum Sulphuricum LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC BioActive Nutritional MILK THISTLE; CHELIDONIUM MAJUS; TARAXACUM OFFICINALE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM SULFATE 3; 3; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0232_eaeb2204-2819-49a3-8ad2-1d9b5308c84e 43857-0232 HUMAN OTC DRUG Tryptophan Tryptophan LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRYPTOPHAN 6 [hp_X]/mL N 20181231 43857-0233_e17193dc-2246-4805-956f-2e9dbdc3ed3e 43857-0233 HUMAN OTC DRUG OB Metab Fucus Vesiculosus, Capsicum Annuum, Nicotinamidum, Spongia Tosta, L-Arginine, Croton Oil, L-Ornithine, Pituitaria Glandula (Suis), Thyroidinum (suis), L-Tyrosine, Calcarea Carbonica, Graphites, Kali Carbonicum LIQUID ORAL 20130926 20180424 UNAPPROVED HOMEOPATHIC BioActive Nutritional FUCUS VESICULOSUS; CAPSICUM; NIACINAMIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; ARGININE; CROTON OIL; ORNITHINE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; TYROSINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; POTASSIUM CARBONATE 2; 3; 5; 5; 6; 6; 6; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0234_a51c874e-e431-46ef-aa71-4859d8171362 43857-0234 HUMAN OTC DRUG Gallic Acid Gallicum Acidum LIQUID ORAL 20130923 UNAPPROVED HOMEOPATHIC BioActive Nutritional GALLIC ACID MONOHYDRATE 6 [hp_X]/mL N 20181231 43857-0235_92f766bc-ca2f-4fd5-ba38-5131ed00af32 43857-0235 HUMAN OTC DRUG Bio Larch Larix Decidua LIQUID ORAL 20131002 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. LARIX DECIDUA FLOWERING TOP 6 [hp_X]/mL N 20181231 43857-0236_04a8669c-c144-4d82-b5e3-a7adad10b541 43857-0236 HUMAN OTC DRUG Bio Olive Olea Europaea,Flos LIQUID ORAL 20131002 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. OLEA EUROPAEA FLOWER 6 [hp_X]/mL N 20181231 43857-0237_b72b71bc-10c1-4b47-b349-ee0cd0807ee8 43857-0237 HUMAN OTC DRUG Bio Pine Pinus Sylvestris LIQUID ORAL 20131002 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PINUS SYLVESTRIS FLOWERING TOP 6 [hp_X]/mL N 20181231 43857-0238_8bcbd185-5c1e-4acf-8aa5-74bfd0775590 43857-0238 HUMAN OTC DRUG Bio Vervain not applicable LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. VERBENA OFFICINALIS FLOWERING TOP 6 [hp_X]/mL N 20181231 43857-0239_08da90b8-c059-42c0-9cf3-2414a4f894f6 43857-0239 HUMAN OTC DRUG Bio White Chestnut Aesculus Hippocastanum, Flos LIQUID ORAL 20140826 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AESCULUS HIPPOCASTANUM FLOWER 6 [hp_X]/mL N 20181231 43857-0240_96ef367d-bfdc-49ab-b5f0-26f09b05c8c2 43857-0240 HUMAN OTC DRUG Bio Willow Salix Vitellina, Flos LIQUID ORAL 20131002 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SALIX ALBA FLOWER 6 [hp_X]/mL N 20181231 43857-0241_224926cc-8840-48ef-a346-41940a48b7d9 43857-0241 HUMAN OTC DRUG Allergen I Potassium Gluconate, Glandula Suprarenalis Bovine, Hepar Bovine, Arsenicum Album, Lycopodium Clavatum, Nux Vomica, Phosphorus, Peanut, Black Walnut, Juglans Regia, Almond, Cashew, Coconut, Pecan, Brazil Nut, Lycopersicum Esculentum, Potato, Black Pepper, Eggplant, Gossypium Herbaceum, Flax, Parmesan Cheese, Milk, Beef, Lamb, Pork, Chicken, Egg, Beans, Allium Cepa, Malus Pumila, Flos, Triticum Aestivum, Banana, Fragaria Vesca, Citrus Sinensis, Cod, Tuna, Salmon, Limulus, Oyster, Shrimp, Cortisone Aceticum LIQUID ORAL 20130926 UNAPPROVED HOMEOPATHIC BioActive Nutritional POTASSIUM GLUCONATE; BOS TAURUS ADRENAL GLAND; BEEF LIVER; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PEANUT; BLACK WALNUT; ENGLISH WALNUT; ALMOND; CASHEW; COCONUT; PECAN; BRAZIL NUT; SOLANUM LYCOPERSICUM; POTATO; BLACK PEPPER; EGGPLANT; LEVANT COTTON SEED; FLAX SEED; SESAME SEED; CASEIN, LACTOCOCCUS LACTIS CULTURED; COW MILK; BEEF; LAMB; PORK; CHICKEN; EGG; KIDNEY BEAN; ONION; MALUS PUMILA FLOWER; WHEAT; BANANA; ALPINE STRAWBERRY; ORANGE; COD, UNSPECIFIED; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; LIMULUS POLYPHEMUS; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; CORTISONE ACETATE; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; SEROTONIN HYDROCHLORIDE 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0242_74a18921-f988-421a-b3c0-12229d607ab9 43857-0242 HUMAN OTC DRUG Serotonin Serotonin (Hydrochloride) LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC BioActive Nutritional SEROTONIN HYDROCHLORIDE 6 [hp_X]/mL N 20181231 43857-0243_9258dcbb-cfec-414e-9ad6-4acb30634988 43857-0243 HUMAN OTC DRUG Serotonin Serotonin LIQUID ORAL 20160523 UNAPPROVED HOMEOPATHIC BioActive Nutritional SEROTONIN HYDROCHLORIDE 6 [hp_X]/mL N 20181231 43857-0244_7d134ead-078f-422e-984f-f07008413234 43857-0244 HUMAN OTC DRUG Metabolism Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Rhamnus Purshiana, Trifolium Pratense, Xanthoxylum Fraxineum, Ascorbic Acid LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; FRANGULA PURSHIANA BARK; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ASCORBIC ACID; CYANOCOBALAMIN; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; CYSTEINE; MANGANESE GLUCONATE; ADENOSINE TRIPHOSPHATE; .ALPHA.-KETOGLUTARIC ACID; FUMARIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; PYRUVIC ACID; UBIDECARENONE; CALCIUM SULFIDE; GERMANIUM SESQUIOXIDE 3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 30; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0245_2fd1d86e-78d3-4db5-891f-b325f6280a02 43857-0245 HUMAN OTC DRUG Serotonin Serotonin (Hydrochloride) LIQUID ORAL 20130930 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SEROTONIN HYDROCHLORIDE 6 [hp_X]/mL N 20181231 43857-0246_58f13b5f-6d26-43e0-849e-12249eb57450 43857-0246 HUMAN OTC DRUG Universaltox Alfalfa, Avena Sativa, Fucus Vesiculosus, Hordeum Vulgare, Nasturtium Aquaticum, Raphanus Sativus, Triticum Aestivum, Iodium, Ubiquinone LIQUID ORAL 20140110 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; FUCUS VESICULOSUS; HORDEUM VULGARE TOP; NASTURTIUM AQUATICUM; RAPHANUS SATIVUS; TRITICUM AESTIVUM WHOLE; IODINE; UBIDECARENONE; SUS SCROFA ADRENAL GLAND; PORK LIVER; MANGANESE GLUCONATE; BROWN RICE; SUS SCROFA THYROID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; CORTISONE ACETATE; PARAFFIN; ETHYLENE GLYCOL; PROPYL ALCOHOL; PALMITIC ACID; DIMETHICONE; SODIUM POLYACRYLATE (8000 MW); GLUTARAL; METHYL ACRYLATE; ANHYDROUS CITRIC ACID; TARTARIC ACID; ANTHRAQUINONE; HYDROGEN PEROXIDE; GLYCOLIC ACID; AMMONIUM THIOGLYCOLATE; SODIUM CARBONATE; ETHANOLAMINE; 2,5-DIAMINOTOLUENE SULFATE; P-AMINOPHENOL 3; 3; 4; 4; 4; 4; 4; 6; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0247_fc175c6d-4af7-414e-a8ea-cc5ba17336dd 43857-0247 HUMAN OTC DRUG Candida Alb Candida Albicans LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 30 [hp_X]/mL N 20181231 43857-0248_253eb7d4-8332-4ac9-b5f7-28d9fb78f258 43857-0248 HUMAN OTC DRUG Prostoforce Aralia Quinquefolia, Damiana, Hydrocotyle Asiatica, Juniperus Virginiana, Pareira Brava, Sabal Serrulata, Thuja Occidentalis, Clematis Erecta, Conium Maculatum, Pulsatilla (Vulgaris) LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; TURNERA DIFFUSA LEAFY TWIG; CENTELLA ASIATICA; JUNIPERUS VIRGINIANA OIL; CHONDRODENDRON TOMENTOSUM ROOT; SAW PALMETTO; THUJA OCCIDENTALIS LEAFY TWIG; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; PULSATILLA VULGARIS 3; 3; 3; 3; 3; 3; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0249_9eaa26b2-9397-4303-bcd3-67c5eb056795 43857-0249 HUMAN OTC DRUG Diathesis I Manganum Metallicum, Germanium Sesquioxide, Fel Tauri, Hepar Suis, Ginkgo Biloba, Cysteinum, Manganese Gluconate, Alpha-Ketoglutaricum Acidum, Arsenicum Album, Fumaricum Acidum, Phosphorus, Sodium Oxalate, Sulphur LIQUID ORAL 20140109 UNAPPROVED HOMEOPATHIC BioActive Nutritionals, Inc. MANGANESE; GERMANIUM SESQUIOXIDE; BOS TAURUS BILE; PORK LIVER; GINKGO; CYSTEINE; MANGANESE GLUCONATE; .ALPHA.-KETOGLUTARIC ACID; ARSENIC TRIOXIDE; FUMARIC ACID; PHOSPHORUS; SODIUM OXALATE; SULFUR 9; 8; 6; 6; 6; 9; 10; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0250_be74e7e2-3aee-450f-b7a1-778185edc3fd 43857-0250 HUMAN OTC DRUG Diathesis V 2 Ginkgo Biloba, Pancreas Suis, Spleen (Suis), Stomach (Suis), Germanium Sesquioxide, Cobaltum Metallicum, Cysteinum, Niccolum Metallicum, Zincum Metallicum, Manganese Gluconate, Alpha-Ketoglutaricum Acidum, Baryta Carbonica, Fumaricum Acidum, Phosphoricum Acidum, Phosphorus, Sodium Oxalate LIQUID ORAL 20170209 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. GINKGO; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; GERMANIUM SESQUIOXIDE; COBALT; CYSTEINE; NICKEL; ZINC; MANGANESE GLUCONATE; OXOGLURIC ACID; BARIUM CARBONATE; FUMARIC ACID; PHOSPHORIC ACID; PHOSPHORUS; SODIUM OXALATE 6; 6; 6; 6; 8; 9; 9; 9; 9; 10; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0251_e9ac3efe-2023-4fd7-92cd-60a915ad8d3b 43857-0251 HUMAN OTC DRUG Candida Alb Candida Albicans LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 200 [hp_X]/mL N 20181231 43857-0252_88e09a08-c7d5-4710-a10d-bd1b4b03d425 43857-0252 HUMAN OTC DRUG Eczemaforce Lappa Major, Phytolacca Decandra, Trifolium Pratense, Hydrocotyle Asiatica, Arsenicum Album, Graphites, Mezereum LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; TRIFOLIUM PRATENSE FLOWER; CENTELLA ASIATICA; ARSENIC TRIOXIDE; GRAPHITE; DAPHNE MEZEREUM BARK 3; 3; 3; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0253_087ff733-b206-46d1-98f6-236d52c17950 43857-0253 HUMAN OTC DRUG CV HP Lycopus Virginicus, Valeriana Officinalis, Aurum Metallicum, Cactus Glandiflorus, Cuprum Aceticum, Digitalis Purpurea, Natrum Muriaticum, Phosphorus, Pulsatilla LIQUID ORAL 20131231 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. LYCOPUS VIRGINICUS; VALERIAN; GOLD; SELENICEREUS GRANDIFLORUS STEM; CUPRIC ACETATE; DIGITALIS; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0254_fb3f2ef5-8647-4b6c-83aa-146f94d1754a 43857-0254 HUMAN OTC DRUG Senility HP Anacardium Orientale, Belladonna, Hyoscyamus Niger, Veratrum Album, Baryta Carbonica, Lachesis Mutus, Phosphorus, Stramonium LIQUID ORAL 20140113 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SEMECARPUS ANACARDIUM JUICE; ATROPA BELLADONNA; HYOSCYAMUS NIGER; VERATRUM ALBUM ROOT; BARIUM CARBONATE; LACHESIS MUTA VENOM; PHOSPHORUS; DATURA STRAMONIUM 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0255_de59039b-7b5e-498c-b287-a003f6f084e6 43857-0255 HUMAN OTC DRUG Eczema HP Arsenicum Album, Calcarea Carbonica, Graphites, Mercurius Solubilis, Mezereum, Rhus Tox, Sepia, Sulphur LIQUID ORAL 20140804 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0256_0721e5e4-458a-478f-a45d-6a603342975b 43857-0256 HUMAN OTC DRUG Dopamine Dopamine LIQUID ORAL 20140812 20180701 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. DOPAMINE 6 [hp_X]/mL N 20181231 43857-0257_6688b20f-ab3b-4dc1-9ccb-9fe972027f55 43857-0257 HUMAN OTC DRUG OB METAB not applicable LIQUID ORAL 20140731 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. FUCUS VESICULOSUS; CAPSICUM; NIACINAMIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; CROTON TIGLIUM SEED; ARGININE; ORNITHINE; TYROSINE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; POTASSIUM CARBONATE 2; 3; 5; 5; 6; 6; 6; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0258_aafb17d3-7e22-4f6b-a349-23d8f7bfe9d0 43857-0258 HUMAN OTC DRUG Cardioforce I Arnica Montana, Cactus Grandiflorus, Capsicum Annuum, Spigelia Anthelmia, Digitalis Purpurea, Kali Phosphoricum, Laurocerasus, Tabacum, Aconitum napellus, Agaricus muscarius, Aurum muriaticum, Glonoinum, Ignatia amara, Kalmia latifolia, Latrodectus Mactans, Valeriana officinalis LIQUID ORAL 20140611 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; SELENICEREUS GRANDIFLORUS STEM; CAPSICUM; SPIGELIA ANTHELMIA; DIGITALIS; POTASSIUM PHOSPHATE, DIBASIC; PRUNUS LAUROCERASUS LEAF; TOBACCO LEAF; ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; GOLD TRICHLORIDE; NITROGLYCERIN; STRYCHNOS IGNATII SEED; KALMIA LATIFOLIA LEAF; LATRODECTUS MACTANS; VALERIAN 3; 3; 3; 3; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0259_38140dba-d03d-4cbd-8e01-42f4c3b049ba 43857-0259 HUMAN OTC DRUG Strength M Aralia quinquefolia, Avena sativa, Damaina, L-Arginne, Epimedium, Glutathion, L-Leucine, L-Ornithine, Valine, Testosterone, Sabal serrulata, Sepia, LIQUID ORAL 20140617 20201110 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; TURNERA DIFFUSA LEAFY TWIG; ARGININE; EPIMEDIUM GRANDIFLORUM TOP; GLUTATHIONE; LEUCINE; ORNITHINE; VALINE; TESTOSTERONE; SAW PALMETTO; SEPIA OFFICINALIS JUICE 3; 3; 3; 6; 6; 6; 6; 6; 6; 12; 24; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0260_6cea2cd0-21dc-4a75-ada4-9f9c93187aa7 43857-0260 HUMAN OTC DRUG Norepinephrine Norepinephrine LIQUID ORAL 20150327 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. NOREPINEPHRINE 6 [hp_X]/mL N 20181231 43857-0261_5a536895-2dcf-4c48-93d5-30debb322bc4 43857-0261 HUMAN OTC DRUG Headache Tonic not applicable LIQUID ORAL 20140812 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MILK THISTLE; TANACETUM PARTHENIUM; CLAVICEPS PURPUREA SCLEROTIUM; ACONITUM NAPELLUS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; MELILOTUS OFFICINALIS TOP; STRYCHNOS NUX-VOMICA SEED; SEPIA OFFICINALIS JUICE; SPIGELIA ANTHELMIA 1; 1; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0262_77373d4f-a057-4c63-af16-25e9a7f8dd79 43857-0262 HUMAN OTC DRUG Psorinum Complex Phosphorus, Silicea, Sulphur, Aloe LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PHOSPHORUS; SILICON DIOXIDE; SULFUR; ALOE 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0263_df1e15cf-fa49-423a-bcb2-c9ef0b0424f7 43857-0263 HUMAN OTC DRUG Biting Insect Antigens Apis Mellifica, Hypericum Perforatum, Ledum Palustre, Cimex Lectularius (Bed Bug), Formica Rufa (Red Wood Ants), Pulex Irritans (Human Flea), Vespa Crabro (Hornet, Wasp) LIQUID ORAL 20140616 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; CIMEX LECTULARIUS; FORMICA RUFA; PULEX IRRITANS; VESPA CRABRO 12; 12; 12; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0264_6f6f45d0-4300-409e-b612-6ec4d8134361 43857-0264 HUMAN OTC DRUG RUTIN not applicable LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. RUTIN 6 [hp_X]/mL N 20181231 43857-0265_40a07315-2e9a-4af1-b5ca-7c3969280753 43857-0265 HUMAN OTC DRUG L DOPA 4X not applicable LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. LEVODOPA 4 [hp_X]/mL N 20181231 43857-0266_f6381166-bf4e-4d6c-8f37-06100ac594e7 43857-0266 HUMAN OTC DRUG Rheumatism HP Bryonia (Alba), Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre, Lycopodium Clavatum, Rhododendron Chrysanthum, Rhus Tox LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0267_155a3af0-5884-448c-b5b3-642b7dc84ac9 43857-0267 HUMAN OTC DRUG SCROPHULOUS HP Baryta Carbonica, Bromium, Calcarea Carbonica, Ferrum Iodatum, Mercurius Solubilis, Phytolacca Decandra, Rhus Tox, Silicea LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BARIUM CARBONATE; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0268_8e1a6c75-1e2c-47e3-a065-fca7dd3253de 43857-0268 HUMAN OTC DRUG Natural Testosterone Avena Sativa. Epimedium, Lycopodium Clavatum, Damiana, Testosterone, Agnus Castus SPRAY ORAL 20140224 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AVENA SATIVA FLOWERING TOP; EPIMEDIUM GRANDIFLORUM TOP; LYCOPODIUM CLAVATUM SPORE; TURNERA DIFFUSA LEAFY TWIG; TESTOSTERONE; CHASTE TREE 3; 3; 3; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0269_783730d4-aa9c-4e58-8109-a2b2d980b442 43857-0269 HUMAN OTC DRUG Bio Star of Bethlehem Ornithogallum Umbellatum, Flos LIQUID ORAL 20140702 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ORNITHOGALUM UMBELLATUM FLOWERING TOP 6 [hp_X]/mL N 20181231 43857-0270_dc876914-1970-42df-bb07-e0978d5f5b08 43857-0270 HUMAN OTC DRUG Acetylcholine Chloride not applicable LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACETYLCHOLINE CHLORIDE 6 [hp_X]/mL N 20181231 43857-0271_a99269f4-8abf-494a-b2a8-74d9351a7b99 43857-0271 HUMAN OTC DRUG Bio Vine Not applicable LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. VITIS VINIFERA FLOWERING TOP 6 [hp_X]/mL N 20181231 43857-0272_5fe223e3-2c46-401a-a585-0507dd3a5861 43857-0272 HUMAN OTC DRUG Coumarin Not applicable LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. COUMARIN 6 [hp_X]/mL N 20181231 43857-0273_c036ba04-8634-4500-a50f-bc09b36df3f6 43857-0273 HUMAN OTC DRUG Androtox Echinacea (Angustifolia), Hydrocotyle Asiatica, Juniperus Virginiana, Sabal Serrulata, Tabebuia Impetiginosa, Thuja Occidentalis, Astragalus Membranaceus, Glandula Suprarenalis Suis, Lymph Node (Suis), Zincum Gluconicum, Mercurius Solubilis, Natrum Sulphuricum, Orchitinum (Suis), Prostate (Suis), Pulsatilla (Vulgaris), Rhododendron Chrysanthum, Spongia Tosta, Calcarea Sulphurica, Lycopodium Clavatum, Phosphorus, Botulinum, Escherichia Coli, Proteus (Vulgaris), Pseudomonas Aeruginosa, Yersinia Enterocolitica LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; CENTELLA ASIATICA; JUNIPERUS VIRGINIANA TWIG; SAW PALMETTO; TABEBUIA IMPETIGINOSA BARK; THUJA OCCIDENTALIS LEAFY TWIG; ASTRAGALUS PROPINQUUS ROOT; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; ZINC GLUCONATE; MERCURIUS SOLUBILIS; SODIUM SULFATE; SUS SCROFA TESTICLE; SUS SCROFA PROSTATE; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; SPONGIA OFFICINALIS SKELETON, ROASTED; CALCIUM SULFATE ANHYDROUS; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA 3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 33; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0274_3d8008ea-76c7-4a2d-a477-a680b83e6b6e 43857-0274 HUMAN OTC DRUG Free Radical not applicable LIQUID ORAL 20140804 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRITICUM AESTIVUM WHOLE; ALFALFA; FUCUS VESICULOSUS; LAMINARIA DIGITATA; NASTURTIUM OFFICINALE; BROWN RICE; RADISH; COMFREY ROOT; HORDEUM VULGARE TOP; ASPARAGUS; MANGANESE GLUCONATE; FERROSOFERRIC PHOSPHATE; ARNICA MONTANA; COPPER; UBIDECARENONE; .ALPHA.-KETOGLUTARIC ACID; GLYOXAL TRIMER DIHYDRATE; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; IRIDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC 1; 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 12; 12; 12; 30; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0275_b8fda148-adeb-4579-8e74-cde068479c3b 43857-0275 HUMAN OTC DRUG Acne HP Carbo Animalis, Carbo Vegetabilis, Kali Bichromicum, Natrum Muriaticum, Pulsatilla (Vulgaris), Sepia, Silicea, Sulphur, Zincum Metallicum LIQUID ORAL 20140804 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CARBO ANIMALIS; ACTIVATED CHARCOAL; POTASSIUM DICHROMATE; SODIUM CHLORIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0276_cea0099a-a87a-4df0-af67-ab13c66a5bca 43857-0276 HUMAN OTC DRUG Bio Rock Rose 6X, 30C, 200C not applicable LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HELIANTHEMUM NUMMULARIUM FLOWER 6 [hp_X]/mL N 20181231 43857-0277_271f3fd7-136d-4a1c-86f3-0d11434b0b29 43857-0277 HUMAN OTC DRUG PYCNOGENOL 6X not applicable LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MARITIME PINE 6 [hp_X]/mL N 20181231 43857-0278_a16684f0-1625-4b52-9d3a-7a70feefdf27 43857-0278 HUMAN OTC DRUG PSORIASIS HP Arsenicum Album, Borax, Graphites, Natrum Muriaticum, Sepia, Sulphur LIQUID ORAL 20150130 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; SODIUM BORATE; GRAPHITE; SODIUM CHLORIDE; SEPIA OFFICINALIS JUICE; SULFUR 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0279_a4a6b2ad-4b70-44e7-be0b-b20684aed52b 43857-0279 HUMAN OTC DRUG Dopamine Dopamine Hydrochloride LIQUID ORAL 20140612 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. DOPAMINE HYDROCHLORIDE 6 [hp_X]/mL N 20181231 43857-0280_b3c0596d-e189-4c2f-be4a-7696bacf1b0b 43857-0280 HUMAN OTC DRUG Endoplex M Not applicable LIQUID ORAL 20140815 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc CHASTE TREE; AMERICAN GINSENG; JUNIPERUS VIRGINIANA TWIG; LYCOPODIUM CLAVATUM SPORE; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SAW PALMETTO; URTICA DIOICA; ZANTHOXYLUM AMERICANUM BARK; SUS SCROFA ADRENAL GLAND; SUS SCROFA TESTICLE; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; CLEMATIS RECTA FLOWERING TOP 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0281_fd9f22c3-c7b1-4d11-8568-babc78063fc1 43857-0281 HUMAN OTC DRUG Cough Syrup Formula not applicable LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. DROSERA ROTUNDIFOLIA; PROTORTONIA CACTI; SPONGIA OFFICINALIS SKELETON, ROASTED; ATROPA BELLADONNA; CUPRIC ACETATE; POTASSIUM CARBONATE; MENTHA PIPERITA; PHOSPHORUS 3; 5; 5; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0282_21bb7cfb-6486-4f73-8fdb-85a19d1855c8 43857-0282 HUMAN OTC DRUG Strength F Alpha-Ketoglutaricum Acidum, Isoleucine, L-Arginine, L Carnitine, L-Leucine, L-Ornithine, L-Valine, Estradiol, Folliculinum, Progesterone, Testosterone, Estriolcidum, Isoleucine, L-Arginine, L Carnitine, L-Leucine, L-Ornithine, L-Valine, Estradiol, Folliculinum, Progesterone, Testosterone, Estriol LIQUID ORAL 20140806 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. .ALPHA.-KETOGLUTARIC ACID; ISOLEUCINE; ARGININE; LEVOCARNITINE; LEUCINE; ORNITHINE; VALINE; ESTRADIOL; ESTRONE; PROGESTERONE; TESTOSTERONE; ESTRIOL 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0283_7ccf225f-c4fa-4eab-aa6d-edb71f054c2c 43857-0283 HUMAN OTC DRUG Lymph III Echinacea (Angustifolia), Phytolacca decandra, Boldo, Pinus sylvestris, Thyroidinum (Suis), Germanium sesquioxide, Arnica montana, Calcarea iodata, Hamamelis virginiana, Hepar sulphuris calcareum, ATP (Adenosine triphosphate disodium), Co-Enzyme Q-10, Naja tripudians, Calcarea phosphorica, Influenzinum, Natrum sulphuricum, Pyrogenium, Sulphur, Carcinosin LIQUID ORAL 20140416 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; PEUMUS BOLDUS LEAF; PINUS SYLVESTRIS LEAFY TWIG; SUS SCROFA THYROID; GERMANIUM SESQUIOXIDE; ARNICA MONTANA; CALCIUM IODIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; ADENOSINE TRIPHOSPHATE DISODIUM; UBIDECARENONE; NAJA NAJA VENOM; TRIBASIC CALCIUM PHOSPHATE; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); SODIUM SULFATE; RANCID BEEF; SULFUR; HUMAN BREAST TUMOR CELL 1; 3; 3; 6; 6; 8; 12; 12; 12; 12; 12; 12; 15; 30; 30; 30; 30; 30; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0284_00b6faa0-8a32-409c-86e7-eb97bf771c34 43857-0284 HUMAN OTC DRUG Androbalance DHEA (Dehydroepiandrosterone) Pregnenolone, Progesterone, Testosterone SPRAY ORAL 20140224 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PRASTERONE; PREGNENOLONE; PROGESTERONE; TESTOSTERONE 6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0285_405d2d71-c0ed-49e7-ad9d-000a911a200f 43857-0285 HUMAN OTC DRUG HA HP NOT APPLICABLE LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; MELILOTUS OFFICINALIS TOP; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0286_1e83bc29-b984-4051-abcb-e275241a0fb8 43857-0286 HUMAN OTC DRUG Osteoplex not applicable LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. EQUISETUM HYEMALE; MAGNESIUM CHLORIDE; COMFREY ROOT; ASCORBIC ACID; MANGANESE CHLORIDE; SUS SCROFA BONE MARROW; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; SILICON DIOXIDE; SUS SCROFA LIGAMENT; SUS SCROFA PARATHYROID GLAND 3; 3; 3; 6; 6; 8; 12; 12; 12; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0287_da1d9ce3-a381-499b-8828-01957cbdb527 43857-0287 HUMAN OTC DRUG Res Balancer Spleen (Bovine), Thymus (Bovine) SPRAY ORAL 20140818 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BOS TAURUS SPLEEN; BOS TAURUS THYMUS 8; 8 [hp_X]/mL; [hp_X]/mL N 20181231 43857-0288_1bfc5213-5b9e-403b-815d-3fabaee65cc3 43857-0288 HUMAN OTC DRUG Lumbagoforce Arnica montana, Hypericum perforatum, Symphytum officinale, Gnaphalium polycephalum, Colocynthis, Formica rufa, Rhus tox LIQUID ORAL 20140310 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; HYPERICUM PERFORATUM; COMFREY ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; CITRULLUS COLOCYNTHIS FRUIT PULP; FORMICA RUFA; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 5; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0289_be076387-8c16-4802-906b-2d05b9294a4f 43857-0289 HUMAN OTC DRUG LYM D Chelidonium majus, Echinacea (angustifolia), Hydrastis canadensis, Nasturtium aquaticim, Taraxacum officinale, Trifolium pratense, Urtica dioica, Thymus (suis), Thyuroidinum (suis), Arsenium album, Coccus cacti, Lycopodium clavatum, Phosphorus, Rhus toxicodendron, Borelia burgdorferi, Ledum palustre LIQUID ORAL 20140331 20190507 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; NASTURTIUM OFFICINALE; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA; SUS SCROFA THYMUS; SUS SCROFA THYROID; ARSENIC TRIOXIDE; PROTORTONIA CACTI; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; BORRELIA BURGDORFERI; LEDUM PALUSTRE TWIG 3; 3; 3; 3; 3; 3; 3; 8; 8; 12; 12; 12; 12; 12; 12; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0290_71f51df0-faf9-414b-8d94-dae5af172d37 43857-0290 HUMAN OTC DRUG Sinuforce Echinacea (Angustifolia), Hydrastis Canadensis, Nux Moschata, Trigonella Foenum Graecum, Arsenicum Album, Kali Bichromicum, Mercurius Sulphuratus Ruber, Pulsatilla (Vulgaris), Sepia, Mercurius Solubilis LIQUID ORAL 20140321 20201118 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; NUTMEG; FENUGREEK SEED; ARSENIC TRIOXIDE; POTASSIUM DICHROMATE; MERCURIC SULFIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; MERCURIUS SOLUBILIS 3; 3; 3; 3; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0291_7bd3a4ed-6366-4c9e-9c13-2bd602f5f251 43857-0291 HUMAN OTC DRUG ASP Echinacea (Angustifolia), Hydrastis canadensis, Tabebuia impetiginosa, Glandula suprarenalis suis, Thymus(suis), Thyroidinum (suis), Arsenicum album, LIQUID ORAL 20140403 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; TABEBUIA IMPETIGINOSA BARK; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; LEDUM PALUSTRE TWIG; MERCURIC CYANIDE; SODIUM SULFATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; ASPERGILLUS FLAVUS 3; 3; 3; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0292_d7fa04be-5591-4b47-acfc-964e9db3f30d 43857-0292 HUMAN OTC DRUG Immuno Fortifier Echinacea (Angustifolia), Hydrastis Canadensis, Ligusticum Porteri, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Trigonella Foenum-Graecum, Ascorbic Acid, Pinus Sylvestris, Lymph (Suis), Medulla Ossis Suis, Spleen (Suis), Thymus (Suis), Hepar Sulphuris Calcareum, Phosphoricum Acidum, Silicea LIQUID ORAL 20140424 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; MYRRH; NASTURTIUM AQUATICUM; LIGUSTICUM PORTERI ROOT; TABEBUIA IMPETIGINOSA BARK; FENUGREEK SEED; ASCORBIC ACID; PINUS SYLVESTRIS LEAFY TWIG; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; CALCIUM SULFIDE; PHOSPHORIC ACID; SILICON DIOXIDE 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0293_40c7b9bc-5fb3-4e8a-bec1-1a3e159c5bc5 43857-0293 HUMAN OTC DRUG FNG I Echinacea (Angustifolia), Hydrastis canadensis, Lomatium dissectum, Nasturtium aquaticum, Tabebuia impetiginosa, Condurango, Ginko biloba, Ligusticum porteri, Astragalus membranaceus, Propolis, Glandula suprarenalis bovine, Thymus (Bovine), Lycopodium clavatum, Nux vomica, Phosphoricum acidum, Phytolacca decandra, Sepia, Alternaria tenuis nees, Aspergillus niger, Candida albicans, Candida parapsilosis, Mucor racemosus, Pullularia pullulans, Rhizopus nigricans, Torula cerevisiae LIQUID ORAL 20140424 20201013 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; MARSDENIA CONDURANGO BARK; GINKGO; LIGUSTICUM PORTERI ROOT; ASTRAGALUS PROPINQUUS ROOT; PROPOLIS WAX; BOS TAURUS ADRENAL GLAND; BOS TAURUS THYMUS; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE 3; 3; 3; 3; 3; 4; 4; 4; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0294_a6a6df11-2370-470b-8475-78d0a0a85fb3 43857-0294 HUMAN OTC DRUG Lymphoplex Myrrha, Trigonella Foenum-Graecum, Pinus Sylvestris, Lymph (Suis), Spleen (Suis), Conium Maculatum, Echinacea (Angustifolia), Hepar Sulphuris Calcareum, Hydrangea Arborescens, Phytolacca Decandra, Silicea LIQUID ORAL 20140425 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MYRRH; FENUGREEK SEED; PINUS SYLVESTRIS LEAFY TWIG; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; HYDRANGEA ARBORESCENS ROOT; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE 3; 3; 6; 8; 8; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0295_1ef5eee8-ec59-4878-815e-be900599d1e1 43857-0295 HUMAN OTC DRUG EAR Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Phytolacca Decandra, Capsicum Annuum, Chamomilla, Ferrum Phosphoricum, Kali Muriaticum, Plantago Major, Pulsatilla (Vulgaris) LIQUID ORAL 20140818 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; CAPSICUM; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS 3; 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0296_86ff59fc-fb4f-43c1-ae64-aea0676cce73 43857-0296 HUMAN OTC DRUG Sinus Tonic Echinacea (Angustifolia), Baptisia Tinctoria, Hydrastis Canadensis, Thiaminum Hydrochloricum, Pyridoxinum Hydrochloricum, Spongia Tosta, Apis Mellifica, Ascorbic Acid, Hepar Sulphuris Calcareum, Kali Bichromicum, Lachesis Mutus, Mercurius Iodatus Ruber, Mercurius Sulphuratus Ruber, Pulsatilla (Vulgaris), Silicea, Sinusitisinum, Pantothenic Acid LIQUID ORAL 20140508 20201223 UNAPPROVED MEDICAL GAS BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; THIAMINE HYDROCHLORIDE; PYRIDOXINE HYDROCHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; APIS MELLIFERA; ASCORBIC ACID; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MERCURIC IODIDE; MERCURIC SULFIDE; PULSATILLA VULGARIS; SILICON DIOXIDE; SINUSITISINUM; PANTOTHENIC ACID 2; 3; 3; 4; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 28 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0297_a50ec3c1-d7ad-4dcc-a220-35a471e38f93 43857-0297 HUMAN OTC DRUG VAX Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Tabebuia Impetiginosa, Trifolium Pratense, Arnica Montana, Calendula Officinalis, Chelidonium Majus, Leptandra Virginica, Ligusticum Porteri, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Taraxacum Officinale, Trigonella Foenum-Graecum, Urtica Dioica, Astragalus Membranaceus, Propolis, Glandula Suprarenalis Suis, Thymus (Suis), Arsenicum Album, Belladonna, Chamomilla, Lycopodium Clavatum, Rhus Tox, Silicea, LIQUID ORAL 20140812 20200520 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; TABEBUIA IMPETIGINOSA BARK; TRIFOLIUM PRATENSE FLOWER; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; FENUGREEK SEED; URTICA DIOICA; ASTRAGALUS PROPINQUUS ROOT; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; ANTIMONY TRISULFIDE; CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS; THIMEROSAL 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 6; 6; 8; 8; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0298_0d566c5f-4fe9-433c-8229-6d5c8f75b610 43857-0298 HUMAN OTC DRUG EVTOX Cochlearia officinalis, Echinacea (Angustifolia), Hydrastis canadensis, Lomatium dissectum, Tabebuia impetiginosa, Propolis, Glandula suprarenalis suis, Thymus (suis), Aranea diadema, Ipecacuanha, Lycopodium clavatum, Muriaticum acidum, Nitricum acidum, Rhus tox, Silicea, EBV nosode, LIQUID ORAL 20140502 20200901 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. COCHLEARIA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; ARANEUS DIADEMATUS; IPECAC; LYCOPODIUM CLAVATUM SPORE; HYDROCHLORIC ACID; NITRIC ACID; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; HUMAN HERPESVIRUS 4 3; 3; 3; 3; 3; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0299_82926f74-2d2e-4644-97cd-4d0cab50af52 43857-0299 HUMAN OTC DRUG Edema HP Apis Mellifica, Arsenicum Album, Digitalis Purpurea, Ferrum Metallicum, Lycopodium Clavatum, Rhus Tox, Sambucus Nigra, Strophanthus Hispidus LIQUID ORAL 20140603 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; DIGITALIS; IRON; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0300_ce6b0ebc-ba1e-490e-abcc-3a9fd62fd361 43857-0300 HUMAN OTC DRUG Cardiotone Adonis Vernalis, Adenosinum Triphosphoricum Dinatrum, Cactus Grandiflorus, Convallaria Majalis, Heart (Suis), Magnesium Gluconate, Potassium Gluconate, Thyroidinum (Suis), Ubidecarenonum, Germanium Sesquioxide, Strophanthus Hispidus, Digitalis Purpurea LIQUID ORAL 20140604 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ADONIS VERNALIS; ADENOSINE TRIPHOSPHATE; SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; PORK HEART; MAGNESIUM GLUCONATE; POTASSIUM GLUCONATE; SUS SCROFA THYROID; UBIDECARENONE; GERMANIUM SESQUIOXIDE; STROPHANTHUS HISPIDUS SEED; DIGITALIS 3; 6; 6; 6; 6; 6; 6; 6; 6; 8; 10; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0301_c52ee746-ed33-40ea-8d8f-c3157f6ec369 43857-0301 HUMAN OTC DRUG V HP Arsenicum Album, Belladonna, Echinacea (Angustifolia), Eupatorium Perfoliatum, Gelsemium Sempervirens, Lycopodium Clavatum, Phosphoricum Acidum, Phosphorus, Pyrogenium, Rhus Tox LIQUID ORAL 20140903 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC ACID; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0302_3cf8bf57-7f01-4352-8ab0-599b84d29ddd 43857-0302 HUMAN OTC DRUG Virotox Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Glandula Suprarenalis Bovine, Thymus (Bovine), Belladonna, Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Pyrogenium LIQUID ORAL 20140603 20210302 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; BOS TAURUS ADRENAL GLAND; BOS TAURUS THYMUS; ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; RANCID BEEF 3; 3; 3; 3; 3; 3; 8; 8; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0303_bf98560a-0dd8-46d9-9e2b-6ec4774bce48 43857-0303 HUMAN OTC DRUG CANDIDA ALB 60X Candida Albicans LIQUID ORAL 20140702 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 60 [hp_X]/mL N 20181231 43857-0304_748d3189-d209-4fa3-945d-7d5b32f1a97b 43857-0304 HUMAN OTC DRUG Lymph II Echinacea (Angustifolia), Phytolacca Decandra, Collinsonia Canadensis, Kali Iodatum, Pinus Sylvestris, Pix Liquida, Ferrum Phosphoricum, Aesculus Hippocastanum, Baryta Carbonica, Berberis Vulgaris, Bufo Rana, Calcarea Carbonica, Causticum, Hepar Sulphuris Calcareum, Kreosotum, Lycopodium Clavatum, Mercurius Solubilis, Natrum Muriaticum, Nitricum Acidum, Phosphorus, Pulsatilla (Vulgaris), Silicea, Stellaria Media, Sulphur, Terebinthina, Thuja Occidentalis LIQUID ORAL 20140621 20210209 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; COLLINSONIA CANADENSIS ROOT; POTASSIUM IODIDE; PINUS SYLVESTRIS LEAFY TWIG; PINE TAR; FERROSOFERRIC PHOSPHATE; HORSE CHESTNUT; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BUFO BUFO CUTANEOUS GLAND; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; CALCIUM SULFIDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE; STELLARIA MEDIA; SULFUR; TURPENTINE OIL; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 6; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0305_586b5837-c2a2-4a87-b333-4c8c637a8bac 43857-0305 HUMAN OTC DRUG Bio Gentian Gentianella Amarella, Flos LIQUID ORAL 20140703 UNAPPROVED HOMEOPATHIC BioActive Nutritional Inc . GENTIANELLA AMARELLA FLOWER 6 [hp_X]/mL N 20181231 43857-0306_c8eee778-2e32-494d-8395-97c703ba6980 43857-0306 HUMAN OTC DRUG Bio Hornbeam 6X, 30C, 200C Carpinus Betulus, Flos LIQUID ORAL 20140703 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CARPINUS BETULUS FLOWERING TOP 6 [hp_X]/mL N 20181231 43857-0307_2d8012be-f305-4e46-8e83-b4814d7f42f4 43857-0307 HUMAN OTC DRUG Bio Scleranthus Scleranthus Annuus, Flos LIQUID ORAL 20140703 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SCLERANTHUS ANNUUS FLOWERING TOP 6 [hp_X]/mL N 20181231 43857-0308_7068573f-2038-4d58-8243-f4b2d553a62a 43857-0308 HUMAN OTC DRUG Bio Gorse Ulex Europaeus, Flos LIQUID ORAL 20140703 UNAPPROVED HOMEOPATHIC BioActive Nutritional Inc. ULEX EUROPAEUS FLOWER 6 [hp_X]/mL N 20181231 43857-0309_af598836-447c-4fed-828f-acefb47c9e29 43857-0309 HUMAN OTC DRUG Histamine 6X Histaminum Hydrochloricum LIQUID ORAL 20140707 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HISTAMINE DIHYDROCHLORIDE 30 [hp_X]/mL N 20181231 43857-0310_d3fc946e-f3f5-490a-bce1-0815c6b2f898 43857-0310 HUMAN OTC DRUG Adrenoplex Echinacea (Angustifolia), Adrenalinum, Glandula suprarenalis bovine, Spleen (suis), Carduus marianus, Lycopodium clavatum, Natrum muriaticum, Phosphoricum acidum LIQUID ORAL 20140708 20190715 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; EPINEPHRINE; BOS TAURUS ADRENAL GLAND; SUS SCROFA SPLEEN; MILK THISTLE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORIC ACID 3; 8; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0311_488c8b46-2c26-45b8-9414-ab75497d5e0f 43857-0311 HUMAN OTC DRUG Systemic Detox Berberis vulgaris, Boldo, Hydrastis canadensis, Lappa major, Sanguinaria canadensis, Taraxacum officinale, Trifolium pratense, Condurango, Ginkgo biloba, Tabebuia impetiginosa, Conium maculatum, Hepar sulphuris calcareum, Lycopodium clavatum, Sarsaparilla, Aloe, Echinacea (Angustifolia), Natrum sulphuricum, Nux vomica, Thuja occidentalis LIQUID ORAL 20140722 20190805 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; PEUMUS BOLDUS LEAF; GOLDENSEAL; ARCTIUM LAPPA ROOT; SANGUINARIA CANADENSIS ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; MARSDENIA CONDURANGO BARK; GINKGO; TABEBUIA IMPETIGINOSA BARK; CONIUM MACULATUM FLOWERING TOP; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; SMILAX REGELII ROOT; ALOE; ECHINACEA ANGUSTIFOLIA; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 3; 3; 3; 6; 6; 6; 12; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0312_c7afea9c-78d8-4a71-bbcb-d8bc876df462 43857-0312 HUMAN OTC DRUG Toxodetox Toxoplasma Gondii LIQUID ORAL 20140711 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TOXOPLASMA GONDII 12 [hp_X]/mL N 20181231 43857-0313_13472161-1cc9-460d-ab65-60edb2101b20 43857-0313 HUMAN OTC DRUG HZ Formula Baptisia Tinctoria, Echinacea (Angustifolia), Lomatium Dissectum, Tabebuia Impetiginosa, Propolis, Spleen (Suis), Thymus (Suis), Throidinum (Suis), Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Chlamydia Trachomatis, Herpes Simplex 1 Nosode, Herpes Simplex 2 Nosode, Candida Albicans, Human Papillomavirus, Trichinella Spiralis LIQUID ORAL 20140711 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc BAPTISIA TINCTORIA; ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; THYROID, PORCINE; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; CHLAMYDIA TRACHOMATIS; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; CANDIDA ALBICANS; HUMAN PAPILLOMAVIRUS; TRICHINELLA SPIRALIS 3; 3; 3; 3; 6; 6; 6; 6; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0314_872ccb13-7247-4336-81cb-444cacbf3691 43857-0314 HUMAN OTC DRUG PMS Angelica Archangelica, Cimicifuga Racemosa, Fucus Vesiculosus, Hypothalamus (Suis), Magnesium Gluconicum Dihydricum, Oophorinum (Suis) Pyridoxinum Hydrochloricum, Bovista, Cuprum Metallicum, Sepia, Zincum Metallicum, Lachesis Mutus LIQUID ORAL 20140714 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; FUCUS VESICULOSUS; SUS SCROFA HYPOTHALAMUS; MAGNESIUM GLUCONATE; SUS SCROFA OVARY; PYRIDOXINE HYDROCHLORIDE; LYCOPERDON UTRIFORME FRUITING BODY; COPPER; SEPIA OFFICINALIS JUICE; ZINC; LACHESIS MUTA VENOM 3; 3; 3; 6; 6; 6; 6; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0315_807dd6fe-cfb3-4812-aec6-b34fd11aee68 43857-0315 HUMAN OTC DRUG SEPTAFORCE Baptisia Tinctoria, Echinacea (Angustifolia), Arsenicum Album, Chininum Sulphuricum, Crotalus Horridus, Lachesis Mutus, Loxosceles Reclusa, Secale Cornutum, Tarentula Cubensis LIQUID ORAL 20140711 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA; ECHINACEA ANGUSTIFOLIA; ARSENIC TRIOXIDE; QUININE SULFATE; CROTALUS HORRIDUS HORRIDUS VENOM; LACHESIS MUTA VENOM; LOXOSCELES RECLUSA; CLAVICEPS PURPUREA SCLEROTIUM; CITHARACANTHUS SPINICRUS; LATRODECTUS MACTANS; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 33 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0316_0cb30600-6634-4a4b-aa62-99483c870c01 43857-0316 HUMAN OTC DRUG Drainage Echinacea (Angustifolia), Phytolacca Decandra, Trifolium Pratense, Calcarea Iodata, Kali Muriaticum, Nitricum Acidum, Phosphoricum Acidum, Sulphur Iodatum LIQUID ORAL 20140715 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; TRIFOLIUM PRATENSE FLOWER; CALCIUM IODIDE; POTASSIUM CHLORIDE; NITRIC ACID; PHOSPHORIC ACID; SULFUR IODIDE 3; 3; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0317_8f38abe9-28a3-49bc-b935-d05fdff9e39c 43857-0317 HUMAN OTC DRUG FNG II Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Nasturtium Aquaticum, Tabebuia Impetiginosa, Iodium, Adrenalinum, Argentum Metallicum, Thymus (Suis), Throidinum (Suis), Phosphoricum Acidum, Candida Albicans, Lycopodium Clavatum, Pulsatilla (Vulgaris), Sepia LIQUID ORAL 20140715 20210121 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; IODINE; EPINEPHRINE; SILVER; SUS SCROFA THYMUS; SUS SCROFA THYROID; PHOSPHORIC ACID; CANDIDA ALBICANS; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0319_3c933df3-3e01-490d-a9a1-88a0cb89f6bb 43857-0319 HUMAN OTC DRUG LIVER TONIC I not applicable LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC BioActive, Inc. MILK THISTLE; LYCOPODIUM CLAVATUM SPORE; TARAXACUM OFFICINALE; CHIONANTHUS VIRGINICUS BARK; QUASSIA AMARA WOOD; BEEF LIVER; CEANOTHUS AMERICANUS LEAF; CITRULLUS COLOCYNTHIS FRUIT PULP; VERONICASTRUM VIRGINICUM ROOT; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TEUCRIUM MARUM 1; 1; 1; 3; 3; 8; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0320_4b324ff7-a770-4f03-91fe-da179b408eaf 43857-0320 HUMAN OTC DRUG Arterioforce II Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Phytolacca Decandra. Myrrha, Nasturtium Aquaticum, Trigonella Foenum-Graecum, Kali Iodatum, Arnica Montana, Cactus Grandiflorus, Propolis, Baryta Carbonica, Conium Maculatum, Secale Cornutum LIQUID ORAL 20140715 20190723 UNAPPROVED HOMEOPATHIC Bio Active Nutritional, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; MYRRH; NASTURTIUM OFFICINALE; FENUGREEK SEED; POTASSIUM IODIDE; ARNICA MONTANA; SELENICEREUS GRANDIFLORUS STEM; PROPOLIS WAX; BARIUM CARBONATE; CONIUM MACULATUM FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM 3; 3; 3; 3; 4; 4; 4; 5; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0321_aa643df9-0439-4f6f-91d2-ba9cf8029cb1 43857-0321 HUMAN OTC DRUG Cardioforce II not applicable LIQUID ORAL 20140718 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc ARTEMISIA ABROTANUM FLOWERING TOP; PEUMUS BOLDUS LEAF; BLACK COHOSH; CONVALLARIA MAJALIS; POTASSIUM PHOSPHATE, DIBASIC; TARAXACUM OFFICINALE; MAGNESIUM SULFATE HEPTAHYDRATE; NERIUM OLEANDER LEAF; SODIUM CHLORIDE; BELLIS PERENNIS 3; 3; 3; 3; 3; 3; 5; 8; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0322_fab24ba5-05df-4e3c-aeea-9cff41eb0aff 43857-0322 HUMAN OTC DRUG LYM D Echinacea (Angustifolia), Hydrastis canadensis, Nasturtium aquaticum, Sanguinaria canadensis, Taraxacum officinale, Trifolium pratense, Urtica dioica, Thymus (suis), Thyroidinum (suis), Arsenicum album, Coccus cacti, Lycopodium clavatum, Phosphorus, Rhus tox, Borrelia burgdorferi, Ledum palustre LIQUID ORAL 20140723 20190811 UNAPPROVED HOMEOPATHIC BioActive Nutritional Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; NASTURTIUM OFFICINALE; SANGUINARIA CANADENSIS ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA; SUS SCROFA THYMUS; SUS SCROFA THYROID; ARSENIC TRIOXIDE; PROTORTONIA CACTI; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; BORRELIA BURGDORFERI; LEDUM PALUSTRE TWIG 3; 3; 3; 3; 3; 3; 3; 8; 8; 12; 12; 12; 12; 12; 12; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0323_7f6f8c92-966e-4795-ad9b-4c95aaa98d5a 43857-0323 HUMAN OTC DRUG Bio Chem Detox Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Purshiana, Stillingia Sylvatica, Trifolium Pratense, Triticum Aestivum, Xanthoxylum Fraxineum, Glandula Suprarenalis Suis, Hepar Suis, Lymph Node (Suis), Thyroidinum (Suis), Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Aconitum Napellus, Arsenicum Album, Belladonna, Carbo Vegetabilis, Cinchona Officinalis, Conium Maculatum, Mercurius Corrosivus, Phosphorus, Sulphur, Tabacum, Nitricum Acidum, Agaricus Muscarius SPRAY ORAL 20140731 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA PURSHIANA BARK; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; TRITICUM AESTIVUM WHOLE; ZANTHOXYLUM AMERICANUM BARK; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA LYMPH; SUS SCROFA THYROID; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ACTIVATED CHARCOAL; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; MERCURIC CHLORIDE; PHOSPHORUS; SULFUR; TOBACCO LEAF; NITRIC ACID; AMANITA MUSCARIA FRUITING BODY; LACHESIS MUTA VENOM; PHYSOSTIGMA VENENOSUM SEED; TUBOCURARINE CHLORIDE 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0324_29842920-4e27-48a7-b7a4-576ae3d1d07d 43857-0324 HUMAN OTC DRUG BIO WILD ROSE NOT APPLICABLE LIQUID ORAL 20140925 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ROSA ARKANSANA ROOT 6 [hp_X]/mL N 20181231 43857-0325_ad3157d8-0ccb-4ffa-9799-955200552271 43857-0325 HUMAN OTC DRUG CVTOX Cochlearia Armoracia, Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Tabebuia Impetiginosa, Propolis, Glandula Suprarenalis Bovine, Thymus (Suis), Aranea Diadema, Ipecacuanha, Lycopodium Clavatum, Muriaticum Acidum, Nitricum Acidum, Phosphoricum Acidum, Rhus Tox, Silicea, Cytomegalovirus Nosode, Epstein-Barr Virus Nosode, Herpes Zoster Nosode, Morbillinum, Poliomyelitis Nosode, Hepatitis B Nosode, Coxsackie B1 Nosode, Coxsackie B4 Nosode LIQUID ORAL 20140804 20200420 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HORSERADISH; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; BOS TAURUS ADRENAL GLAND; SUS SCROFA THYMUS; ARANEUS DIADEMATUS; IPECAC; LYCOPODIUM CLAVATUM SPORE; HYDROCHLORIC ACID; NITRIC ACID; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 3; MEASLES VIRUS; POLIOVIRUS; HEPATITIS B VIRUS; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4 3; 3; 3; 3; 3; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 33; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0326_90c036d9-ac2b-4546-86e1-327f73c70ee4 43857-0326 HUMAN OTC DRUG Diathesis IV Fel Tauri, Ginkgo Biloba, Kidney (Suis), Germanium Sesquioxide, Argentum Metallicum, Cuprum Metallicum, Cysteinum, Aurum Metallicum, Manganese Gluconate, alpha-Ketoglutaricum Acidum, Fumaricum Acidum, Mercurius Solubilis, Natrum Oxalaceticum, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BOS TAURUS BILE; GINKGO; PORK KIDNEY; GERMANIUM SESQUIOXIDE; SILVER; COPPER; CYSTEINE; GOLD; MANGANESE GLUCONATE; .ALPHA.-KETOGLUTARIC ACID; FUMARIC ACID; MERCURIUS SOLUBILIS; SODIUM DIETHYL OXALACETATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 5; 6; 6; 8; 9; 9; 9; 9; 10; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0327_0800a9d3-2ab3-4453-b164-90f003e5a6f4 43857-0327 HUMAN OTC DRUG Bio Water Violet not applicable LIQUID ORAL 20140828 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HOTTONIA PALUSTRIS FLOWER 6 [hp_X]/mL N 20181231 43857-0328_7e3e2ce2-4659-426c-8ac9-fc2fce550a6d 43857-0328 HUMAN OTC DRUG Liver Tonic II Boldo, Carduus Marianus, Curcuma Longa, Echinacea (Angustifolia), Taraxacum Officinale Magnesia Phosphorica, Gallbladder (Bovine), Hepar Bovine, Ammi Visnaga, Atropinum Sulphuricum, Chelidonium Majus, Leptandra Virginica, Podophyllinum LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PEUMUS BOLDUS LEAF; MILK THISTLE; TURMERIC; ECHINACEA ANGUSTIFOLIA; TARAXACUM OFFICINALE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; BOS TAURUS GALLBLADDER; BEEF LIVER; AMMI VISNAGA FRUIT; ATROPINE SULFATE; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; PODOPHYLLUM RESIN 1; 1; 1; 1; 1; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0329_c3b29917-9efb-428b-803a-26ff39b92476 43857-0329 HUMAN OTC DRUG Dust Mix Antigens Arsenicum Album, Drosera (Rotundifolia), Lycopodium Clavatum, Pothos Foetidus, Pulsatilla (Vulgaris), Barley, Corn, House, Mattress, Millet, Milo, Oat, Rice, Rug, Upholstery, Wheat LIQUID ORAL 20140828 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; DROSERA ROTUNDIFOLIA; LYCOPODIUM CLAVATUM SPORE; SYMPLOCARPUS FOETIDUS ROOT; PULSATILLA VULGARIS; BARLEY; CORN; HOUSE DUST; MILLET; SORGHUM BICOLOR WHOLE; OAT; WHITE RICE; WHEAT 12; 12; 12; 12; 12; 9; 9; 9; 9; 9; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0330_fb2146f8-955a-4484-8504-4921cff6c646 43857-0330 HUMAN OTC DRUG Renotox Triticum Aestivum, Asparagus Officinalis, Barosma (Betulina)Berberis Vulgaris, Echinacea (Angustifolia, Kali Muriaticum, Petroselinum Sativum, Sabal Serrulata, Solidago Virgaurea, Taraxacum Officinale, Uva-Ursi, Eupatorium Purpureum, Kidney (Suis), Bryonia (Alba), Mercurius Corrosivus, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cesium Chloride LIQUID ORAL 20140826 20190911 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRITICUM AESTIVUM WHOLE; ASPARAGUS; AGATHOSMA BETULINA LEAF; BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; POTASSIUM CHLORIDE; PETROSELINUM CRISPUM; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF; EUTROCHIUM PURPUREUM ROOT; PORK KIDNEY; BRYONIA ALBA ROOT; MERCURIC CHLORIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; CLOSTRIDIUM PERFRINGENS; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; IRIDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; MEASLES VIRUS; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); HUMAN HERPESVIRUS 4; POLIOVIRUS; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA 1; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 12; 12; 33; 15; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0331_16c1f72a-893f-4d9b-b219-e32bf1cee81e 43857-0331 HUMAN OTC DRUG ADRENOPLEX Chelidonium Majus, Echinacea (Angustifolia), Glandula Suprarenalis Bovine, Spleen (Suis), Carduus Marianus, Lycopodium Clavatum, Natrum Muriaticum, Phosphoricum Acidum LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; BOS TAURUS ADRENAL GLAND; SUS SCROFA SPLEEN; MILK THISTLE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORIC ACID 3; 3; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0332_05d07957-21c7-43be-88a7-a535977d4ab2 43857-0332 HUMAN OTC DRUG Albuminuriaforce Equisetum Hyemale, Solidago Virgaurea, Apis Mellifica, Mercurius Corrosivus, Nux Moschata, Phosphorus, Terebinthina LIQUID ORAL 20140903 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. EQUISETUM HYEMALE; SOLIDAGO VIRGAUREA FLOWERING TOP; APIS MELLIFERA; MERCURIC CHLORIDE; NUTMEG; PHOSPHORUS; TURPENTINE OIL 3; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0333_aeae3eec-af1f-4f14-a8d3-ec8ec881914a 43857-0333 HUMAN OTC DRUG Female Tonic Condurango, Humulus Lupulus, Agnus Castus, Caulophyllum Thalictroides, Iris Versicolor, Lilium Tigrinum, Asterias Rubens, Apis Mellifica, Calcarea Fluorica, Conium Maculatum, Ignatia Amara, Lac Caninum, Lachesis Mutus, Sepia Cyclamen Europaeum LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MARSDENIA CONDURANGO BARK; HOPS; CHASTE TREE; CAULOPHYLLUM THALICTROIDES ROOT; IRIS VERSICOLOR ROOT; LILIUM LANCIFOLIUM WHOLE FLOWERING; ASTERIAS RUBENS; APIS MELLIFERA; CALCIUM FLUORIDE; CONIUM MACULATUM FLOWERING TOP; STRYCHNOS IGNATII SEED; CANIS LUPUS FAMILIARIS MILK; LACHESIS MUTA VENOM; SEPIA OFFICINALIS JUICE; CYCLAMEN PURPURASCENS TUBER 1; 1; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0334_4907b07c-2b02-4d1f-b5d6-6df8d9686032 43857-0334 HUMAN OTC DRUG Hepatatox Triticum Aestivum, Chelidonium Majus, Taraxacum Officinale, Glutathione, Hepar Suis, Thyroidinum (Suis), Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Salicylicum Acidum, Adrenocorticotrophin, Cortisone Aceticum, Eugenol, Stearyl Alcohol, Xylitol, Folliculinum, Benzoicum Acidum, Chlorinum Potassium Sorbate, Sorbitol, Resorcinum, Benzyl Alcohol, Lacticum Acidum, Isopropyl Palmitate, Boricum Acidum, Aceticum Acidum, Phenyl Butazone, Petroleum Jelly, Plumbum Metallicum LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc TRITICUM AESTIVUM WHOLE; CHELIDONIUM MAJUS; TARAXACUM OFFICINALE; GLUTATHIONE; PORK LIVER; SUS SCROFA THYROID; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; SALICYLIC ACID; CORTICOTROPIN; CORTISONE ACETATE; EUGENOL; STEARYL ALCOHOL; XYLITOL; ESTRONE; BENZOIC ACID; CHLORINE; POTASSIUM SORBATE; SORBITOL; RESORCINOL; BENZYL ALCOHOL; LACTIC ACID, DL-; ISOPROPYL PALMITATE; BORIC ACID; ACETIC ACID; PHENYLBUTAZONE; PETROLATUM; LEAD 1; 3; 3; 6; 8; 8; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0335_97168e18-d266-4482-a0aa-b3671594155a 43857-0335 HUMAN OTC DRUG Flu Tonic Echinacea (Angustifolia), Uva-Ursi, Baptisia Tinctoria, Convallaria Majalis, Kali Muriaticum, Pinus Sylvestris, Thuja Occidentalis, Bryonia (Alba), Condurango, Crotalus Horridus, Ginkgo Biloba, Lachesis Mutus, Selenium Metallicum, Tabebuia Impetiginosa, Viscum Album LIQUID ORAL 20140911 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; ARCTOSTAPHYLOS UVA-URSI LEAF; BAPTISIA TINCTORIA ROOT; CONVALLARIA MAJALIS; POTASSIUM CHLORIDE; PINUS SYLVESTRIS LEAFY TWIG; THUJA OCCIDENTALIS LEAFY TWIG; BRYONIA ALBA ROOT; MARSDENIA CONDURANGO BARK; CROTALUS HORRIDUS HORRIDUS VENOM; GINKGO; LACHESIS MUTA VENOM; SELENIUM; TABEBUIA IMPETIGINOSA BARK; VISCUM ALBUM FRUITING TOP 1; 1; 3; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0336_89a000be-ceac-4a6f-8d12-a1d009b4a7e4 43857-0336 HUMAN OTC DRUG INDUSTROTOX NOT APPLICABLE LIQUID ORAL 20141003 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. GLYCYRRHIZA GLABRA; PLANTAGO MAJOR; STILLINGIA SYLVATICA ROOT; COMFREY ROOT; TRIFOLIUM PRATENSE FLOWER; ARNICA MONTANA; ASCLEPIAS TUBEROSA ROOT; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; EUCALYPTUS GLOBULUS LEAF; ARCTIUM LAPPA ROOT; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; TARAXACUM OFFICINALE; FENUGREEK SEED; URTICA DIOICA; ZANTHOXYLUM AMERICANUM BARK; PORK LIVER; SUS SCROFA LUNG; SUS SCROFA LYMPH; ATROPA BELLADONNA; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0337_c25f2cd5-a38c-4350-ad4f-d67d84d82be3 43857-0337 HUMAN OTC DRUG Metalogin Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Stillingia Sylvatica, Trifolium Pratense, Methionine, Thyroidinum (Suis), Selenium Dioxide, Lycopodium Clavatum, Nux Vomica, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium Metallicum, Cobaltum Metallicum LIQUID ORAL 20140818 20200212 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. GARLIC; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; METHIONINE; SUS SCROFA THYROID; SELENIUM DIOXIDE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; IRIDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0338_da5554bc-a0c4-458a-9dea-d97da0943111 43857-0338 HUMAN OTC DRUG PSORIAFORCE NOT APPLICABLE LIQUID ORAL 20141015 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; GLYCYRRHIZA GLABRA; GOLDENSEAL; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ARSENIC TRIIODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CLEMATIS RECTA FLOWERING TOP; GRAPHITE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; DAPHNE MEZEREUM BARK; KEROSENE; SEPIA OFFICINALIS JUICE 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0339_1b60de8a-3cec-47fc-821f-7981e4e7e174 43857-0339 HUMAN OTC DRUG SILICEA COMPLEX II NOT APPLICABLE LIQUID ORAL 20141015 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; TRIFOLIUM PRATENSE FLOWER; CALCIUM IODIDE; POTASSIUM CHLORATE; NITRIC ACID; PHOSPHORIC ACID; SULFUR IODIDE; DIMETHICONE 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0340_fe58d4a0-2153-429b-9e49-1c7354fec2c8 43857-0340 HUMAN OTC DRUG RENAFORCE Berberis Vulgaris, Echinacea (Angustifolia), Coccus Cacti, Kali Muriaticum, Lycopodium Clavatum, Nitricum Acidum LIQUID ORAL 20141015 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; PROTORTONIA CACTI; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0341_e25890de-0254-4afd-b53a-8af35a83c0c0 43857-0341 HUMAN OTC DRUG VARICO HP NOT APPLICABLE LIQUID ORAL 20141020 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CALCIUM FLUORIDE; ACTIVATED CHARCOAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM; DELPHINIUM STAPHISAGRIA SEED; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0342_46f62ae1-0bfb-4431-9bad-669a49a1697c 43857-0342 HUMAN OTC DRUG Neurotox Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Gelsemium Sempervirens, Latrodectus Mactans, Rhus Tox, Tarentula Cubensis, Salmonella Typhi, Clostridium Perfringens, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium Metallicum, Cobaltum Metallicum, Cuprum Metallicum, LIQUID ORAL 20141121 20191125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMANITA MUSCARIA FRUITING BODY; PROTORTONIA CACTI; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE; GELSEMIUM SEMPERVIRENS ROOT; LATRODECTUS MACTANS; TOXICODENDRON PUBESCENS LEAF; CITHARACANTHUS SPINICRUS; HUMAN HERPESVIRUS 4; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; POLIOVIRUS; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; CLOSTRIDIUM PERFRINGENS 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 33; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0343_5b3e9f56-71aa-4912-ac16-d6effeec9c96 43857-0343 HUMAN OTC DRUG DV HP NOT APPLICABLE LIQUID ORAL 20141125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0344_f8c01b0c-8955-446e-a855-c478bbff1ba7 43857-0344 HUMAN OTC DRUG Lymph III Echinacea (Angustifolia), Phytolacca Decandra, Boldo, Pinus Sylvestris, Thyroidinum (Suis), Germanium Sesquioxide, Arnica Montana, Calcarea Iodata, Hamamelis Virginiana, Hepar Sulphuris Calcareum, Adenosinum Triphosphoricum Dinatrum, Ubidecarenonum, Naja Tripudians, Calcarea Phosphorica, Influenzinum, Natrum Sulphuricum, Pyrogenium, Sulphur, Carcinosin LIQUID ORAL 20141118 20201106 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; PEUMUS BOLDUS LEAF; PINUS SYLVESTRIS LEAFY TWIG; THYROID, PORCINE; GERMANIUM SESQUIOXIDE; ARNICA MONTANA; CALCIUM IODIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; ADENOSINE TRIPHOSPHATE DISODIUM; UBIDECARENONE; NAJA NAJA VENOM; TRIBASIC CALCIUM PHOSPHATE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; SODIUM SULFATE; RANCID BEEF; SULFUR; HUMAN BREAST TUMOR CELL 1; 3; 3; 6; 6; 8; 12; 12; 12; 12; 12; 12; 15; 30; 30; 30; 30; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0345_e035bf23-b17e-47c8-a17d-6e10c071bf02 43857-0345 HUMAN OTC DRUG LIVER TONIC I Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Chionanthus Virginica, Quassia (Amara), Hepar Bovine, Ceanothus Americanus Colocynthis, Leptandra Virginica, Natrum Sulphuricum, Nux Vomica, Phosphorus, Teucrium Marum LIQUID ORAL 20141125 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MILK THISTLE; CHELIDONIUM MAJUS; TARAXACUM OFFICINALE; CHIONANTHUS VIRGINICUS BARK; QUASSIA AMARA WOOD; BEEF LIVER; CEANOTHUS AMERICANUS LEAF; CITRULLUS COLOCYNTHIS FRUIT PULP; VERONICASTRUM VIRGINICUM ROOT; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TEUCRIUM MARUM 1; 1; 1; 3; 3; 8; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0346_7c2ea190-74de-4a7b-9a9d-a0e0e501c9b6 43857-0346 HUMAN OTC DRUG ENERGIZER PHOSPHORICUM ACIDUM, COCCULUS INDICUS, HELONIAS DIOICA, IGNATIA AMARA, SEPIA, ZINCUM METALLICUM LIQUID ORAL 20141216 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PHOSPHORIC ACID; ANAMIRTA COCCULUS SEED; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; SEPIA OFFICINALIS JUICE; ZINC 4; 6; 6; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0347_ac882809-fe9c-440d-ac0c-46ff1128f90c 43857-0347 HUMAN OTC DRUG PHLORIDZIN NOT APPLICABLE LIQUID ORAL 20141119 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PHLORIZIN 6 [hp_X]/mL N 20181231 43857-0348_bb26b496-a71a-46f2-8796-277da2f5febd 43857-0348 HUMAN OTC DRUG MAMMARYPLEX Echinacea (Angustifolia), Hydrastis Canadensis, Myrrha, Phytolacca Decandra, Trigonella Foenum-Graecum, Lymph (Suis), Spleen (Suis), Bryonia (Alba), Bufo Rana, Conium Maculatum, Lac Caninum, Lachesis Mutus, Silicea, Mammary Gland (Human) LIQUID ORAL 20141201 20191204 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; MYRRH; PHYTOLACCA AMERICANA ROOT; FENUGREEK SEED; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CONIUM MACULATUM FLOWERING TOP; CANIS LUPUS FAMILIARIS MILK; LACHESIS MUTA VENOM; SILICON DIOXIDE; HUMAN MAMMARY GLAND 3; 3; 3; 3; 3; 8; 8; 12; 12; 12; 12; 12; 12; 36 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0349_4ae0c574-29d6-499c-83dc-9e9b3d9bcf7e 43857-0349 HUMAN OTC DRUG LYM D Chelidonium Majus, Echinacea (Angustifolia), Hydrastis Canadensis, Nasturtium Aquaticum, Taraxacum Officinale, Trifolium Pratense, Urtica Dioica, Thymus (Suis), Thyroidinum (Suis), Arsenicum Album, Coccus Cacti, Lycopodium Clavatum, Phosphorus, Rhus Tox, Borrelia Burgdorferi, Ledum Palustre LIQUID ORAL 20141202 20200901 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; NASTURTIUM OFFICINALE; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA; SUS SCROFA THYMUS; THYROID, PORCINE; ARSENIC TRIOXIDE; PROTORTONIA CACTI; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; BORRELIA BURGDORFERI; LEDUM PALUSTRE TWIG 3; 3; 3; 3; 3; 3; 3; 8; 8; 12; 12; 12; 12; 12; 12; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0350_904424ba-9abf-4c77-89d2-ade2e33d42b3 43857-0350 HUMAN OTC DRUG BIO CLEMATIS CLEMATIS VITALBA FLOWER LIQUID ORAL 20141204 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CLEMATIS VITALBA FLOWER 6 [hp_X]/mL N 20181231 43857-0351_75d71207-90ce-4a73-961d-5bfe34e20daf 43857-0351 HUMAN OTC DRUG Osteoforce Medulla Ossis Suis, Calcarea Carbonica, Calcarea Fluorica, Causticum, Cocculus Indicus, Ledum Palustre, Phosphoricum Acidum, Rhus Tox LIQUID ORAL 20141204 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SUS SCROFA BONE MARROW; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; ANAMIRTA COCCULUS SEED; LEDUM PALUSTRE TWIG; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0352_44af734f-d81e-4468-8120-9d3c86495e1f 43857-0352 HUMAN OTC DRUG BIO CRAB APPLE CRAB APPLE LIQUID ORAL 20141215 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. MALUS SYLVESTRIS FLOWER 6 [hp_X]/mL N 20181231 43857-0353_b3a7fc86-cae7-4a09-9d3e-a7b299cc1a5a 43857-0353 HUMAN OTC DRUG Influaforce Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Propolis, Bryonia (Alba), Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Ipecacuanha, Mercurius Corrosivus, Pyrogenium, Influenzinum LIQUID ORAL 20150914 20201110 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; MERCURIC CHLORIDE; RANCID BEEF; INFLUENZA A VIRUS; INFLUENZA B VIRUS 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 30; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0354_c35c339f-215a-47bb-92ff-1ad7de91ed05 43857-0354 HUMAN OTC DRUG THYRO TONIC Chelidonium Majus, Spongia Tosta, Lac Defloratum, Fucus Vesiculosus, Hepar Suis, Hypophysis Suis, Thyroidinum (Suis), Calcarea Carbonica, Ferrum Iodatum, Iodium, Kali Iodatum, Molybdenum, Pulsatilla (Vulgaris) LIQUID ORAL 20150116 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; SPONGIA OFFICINALIS SKELETON, ROASTED; SKIM MILK; FUCUS VESICULOSUS; PORK LIVER; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; IODINE; POTASSIUM IODIDE; MOLYBDENUM; PULSATILLA VULGARIS 3; 3; 4; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0355_ea4b58c7-4526-4630-a461-07f8b4a4123e 43857-0355 HUMAN OTC DRUG Systemic Detox Berberis Vulgaris, Boldo, Chelidonium Majus, Hydrastis Canadensis, Lappa Major, Taraxacum Officinale, Trifolium Pratense, Condurango, Ginko Biloba, Tabebuia Impetiginosa, Conium Maculatum, Hepar Sulphuris Calcareum, Lycopodium Clavatum, Sarsaparilla (Smilax Regelii), Aloe, Echinacea (Angustifolia), Natrum Sulphuricum, Nux Vomica, Thuja Occidentalis LIQUID ORAL 20150205 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; GOLDENSEAL; ARCTIUM LAPPA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; MARSDENIA CONDURANGO BARK; GINKGO; TABEBUIA IMPETIGINOSA BARK; CONIUM MACULATUM FLOWERING TOP; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; SMILAX REGELII ROOT; ALOE; ECHINACEA ANGUSTIFOLIA; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 3; 3; 3; 6; 6; 6; 12; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0356_63bfe83b-3620-4d55-bf36-7a5356e9d66f 43857-0356 HUMAN OTC DRUG Renotox Triticum Aestivum, Asparagus Officinalis, Barosma (Betulina), Berberis Vulgaris, Echinacea (Angustifolia), Kali Muriaticum, Petroselinum Sativum, Sabal Serrulata, Solidago Virgaurea, Taraxacum Officinale, Uva-Ursi, Eupatorium Purpureum, Kidney (suis), Bryonia (Alba), Mercurius Corrosivus, Epstein-Barr Virus Nosode, Influenzinum, Morbillinum, Poliomyelitis Nosode, Salmonella Typhi Nosode, Clostridium Perfringens, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album LIQUID ORAL 20150130 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRITICUM AESTIVUM WHOLE; ASPARAGUS; AGATHOSMA BETULINA LEAF; BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; POTASSIUM CHLORIDE; PETROSELINUM CRISPUM; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF; EUTROCHIUM PURPUREUM ROOT; PORK KIDNEY; BRYONIA ALBA ROOT; MERCURIC CHLORIDE; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; HUMAN HERPESVIRUS 4; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; POLIOVIRUS; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; CLOSTRIDIUM PERFRINGENS 1; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 33; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0357_54058c53-7234-4044-b3c2-ada849938244 43857-0357 HUMAN OTC DRUG Pneumotox Triticum Aestivum, Alfalfa, Arnica Montana, Asclepias Tuberosa, Chamomilla, Echinacea, Eucalyptus Globulus, Fucus Vesiculosus, Hordeum Vulgare, Laminaria Digitata, Nasturtium Aquaticum, Plantago Major, Raphanus Sativus, Symphytum Officinale, Trifolium Pratense, Trigonella Foenum-Graecum, Oryza Sativa, Lung (Suis), Silicea, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Arsenicum Album, Natrum Muriaticum, LIQUID ORAL 20150129 20200224 UNAPPROVED HOMEOPATHIC BioActive Nutritional TRITICUM AESTIVUM WHOLE; ALFALFA; ARNICA MONTANA; ASCLEPIAS TUBEROSA FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; EUCALYPTUS GLOBULUS LEAF; FUCUS VESICULOSUS; HORDEUM VULGARE TOP; LAMINARIA DIGITATA; NASTURTIUM OFFICINALE; PLANTAGO MAJOR; RAPHANUS SATIVUS; COMFREY ROOT; TRIFOLIUM PRATENSE FLOWER; FENUGREEK SEED; BROWN RICE; SUS SCROFA LUNG; SILICON DIOXIDE; ACETONE; SODIUM TRIPOLYPHOSPHATE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; AMMONIUM CHLORIDE; SODIUM LAURYL SULFATE; TURPENTINE OIL; ARSENIC TRIOXIDE; SODIUM CHLORIDE; NITRIC ACID; OENANTHE AQUATICA FRUIT; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; PARAFFIN; ETHYLENE GLYCOL; PROPYL ALCOHOL; PALMITIC ACID; DIMETHICONE; SODIUM POLYACRYLATE (8000 MW); GLUTARAL; METHYL METHACRYLATE; ANHYDROUS CITRIC ACID; TARTARIC ACID; ANTHRAQUINONE; HYDROGEN PEROXIDE; GLYCOLIC ACID; AMMONIUM THIOGLYCOLATE; SODIUM CARBONATE; MONOETHANOLAMINE; 2,5-DIAMINOTOLUENE SULFATE; P-AMINOPHENOL 1; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 8; 8; 8; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0358_a173b6dd-278f-4d56-989a-aaae426a2998 43857-0358 HUMAN OTC DRUG ACETALDEHYDE Acetaldehyde LIQUID ORAL 20150202 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ACETALDEHYDE 6 [hp_X]/mL N 20181231 43857-0360_2ce28d5e-f706-4e22-8481-f9ee37f06b30 43857-0360 HUMAN OTC DRUG Bio Honeysuckle Lonicera Caprifolium, Flos LIQUID ORAL 20150326 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. LONICERA CAPRIFOLIUM FLOWERING TOP 6 [hp_X]/mL N 20181231 43857-0361_fef8af2e-2be7-434a-9536-76a52eddc9ff 43857-0361 HUMAN OTC DRUG Convoforce Belladonna, Bufo Rana, Cicuta Virosa, Cina, Cuprum Metallicum, Hyoscyamus Niger, Moschus, Stramonium LIQUID ORAL 20150327 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ATROPA BELLADONNA; BUFO BUFO CUTANEOUS GLAND; CICUTA VIROSA ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; COPPER; HYOSCYAMUS NIGER; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; DATURA STRAMONIUM 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0362_436ab29f-f8e0-40b1-a149-1f8012cfc439 43857-0362 HUMAN OTC DRUG Enviroforce Hydrastis Canadensis, Phytolacca Decandra, Sarsaparilla (Smilax Regelii), Xanthoxylum Fraxineum, Aurum Metallicum, Carbo Animalis, Causticum, Iodium, Sulphur, Thuja Occidentalis LIQUID ORAL 20150406 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; SMILAX REGELII ROOT; ZANTHOXYLUM AMERICANUM BARK; GOLD; CARBO ANIMALIS; CAUSTICUM; IODINE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0363_47a2ff1f-0c54-4088-bc42-215edbe83daa 43857-0363 HUMAN OTC DRUG Orchiforce Avena Sativa, Damiana, Agnus Castus, Caladium Seguinum, Conium Maculatum, Phosphoricum Acidum, Phosphorus, Picricum Acidum LIQUID ORAL 20150406 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AVENA SATIVA FLOWERING TOP; TURNERA DIFFUSA LEAFY TWIG; CHASTE TREE; DIEFFENBACHIA SEGUINE; CONIUM MACULATUM FLOWERING TOP; PHOSPHORIC ACID; PHOSPHORUS; PICRIC ACID 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0364_e8013719-fffb-4224-9d70-06daca62e00c 43857-0364 HUMAN OTC DRUG Bio Holly Ilex Aquifolium (Holly), Flos LIQUID ORAL 20150401 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ILEX AQUIFOLIUM FRUITING TOP 6 [hp_X]/mL N 20181231 43857-0365_ac3eca87-c69e-419e-b8fa-e6c90fe8250d 43857-0365 HUMAN OTC DRUG Salsolinol Salsolinol LIQUID ORAL 20150422 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SALSOLINOL 6 [hp_X]/mL N 20181231 43857-0366_b39c9878-e192-4e20-b697-2d686de03492 43857-0366 HUMAN OTC DRUG Bio Sweet Chestnut Castanea Sativa (Sweet Chestnut), Flos LIQUID ORAL 20150428 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CASTANEA SATIVA FLOWER 6 [hp_X]/mL N 20181231 43857-0367_22da851b-0128-4740-90c8-39114b16eb4a 43857-0367 HUMAN OTC DRUG Burn Aide Calendula Officinalis, Hypericum Perforatum, Arsenicum Album, Belladonna, Cantharis, Causticum, Picricum Acidum, Urtica Urens SPRAY TOPICAL 20150521 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; ARSENIC TRIOXIDE; ATROPA BELLADONNA; LYTTA VESICATORIA; CAUSTICUM; PICRIC ACID; URTICA URENS 1; 1; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0368_a0ec5037-ab0e-4a33-bcf0-0acc16692d18 43857-0368 HUMAN OTC DRUG Coniferyl Alcohol Coniferyl Alcohol LIQUID ORAL 20150429 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CONIFERYL ALCOHOL 6 [hp_X]/mL N 20181231 43857-0369_3146eed5-1143-449c-8df8-32854d620716 43857-0369 HUMAN OTC DRUG Colic Beta Vulgaris, Carduus Marianus, Lappa Major, Aluminium Metallicum, Arsenicum Album, Chelidonium Majus, Hydrastis Canadensis, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phsophorus LIQUID ORAL 20150521 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BETA VULGARIS; MILK THISTLE; ARCTIUM LAPPA ROOT; ALUMINUM; ARSENIC TRIOXIDE; CHELIDONIUM MAJUS; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0370_41b0b0e1-1bf2-4aab-b1c7-c8020e5f1763 43857-0370 HUMAN OTC DRUG Mammaryplex Echinacea (Angustifolia), Hydrastis Canadensis, Myrrha, Phytolacca Decandra, Trigonella Foenum Graecum, Lymph Node (Suis), Spleen (Suis), Bryonia (Alba), Bufo Rana, Conium Maculatum, Lac Caninum, Lachesis Mutus, Silicea, Mammary Gland (Bovine) LIQUID ORAL 20150505 20201214 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; MYRRH; PHYTOLACCA AMERICANA ROOT; FENUGREEK SEED; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CONIUM MACULATUM FLOWERING TOP; CANIS LUPUS FAMILIARIS MILK; LACHESIS MUTA VENOM; SILICON DIOXIDE; BOS TAURUS MAMMARY GLAND 3; 3; 3; 3; 3; 8; 8; 12; 12; 12; 12; 12; 12; 36 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0371_3480fff4-4338-4fd8-9eb9-98b0dd99dfc6 43857-0371 HUMAN OTC DRUG Metalogin Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Rhamnus Frangula, Stillingia Sylvatica, Trifolium Pratense, Methionine, Thyroidinum (Suis), Selenium Dioxide, Lycopodium Clavatum, Nux Vomica, Lanthanum Oxide, Niobium Metallicum, Tantalum Metallicum, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum LIQUID ORAL 20150722 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. GARLIC; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; METHIONINE; SUS SCROFA THYROID; SELENIUM DIOXIDE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; LANTHANUM; NIOBIUM; TANTALUM; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; IRIDIUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 12; 12; 14; 30; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0372_e9e9be76-4b66-42b5-80de-bea58b041b1b 43857-0372 HUMAN OTC DRUG Diathesis II Germanium Sesquioxide, Cuprum Metallicum, Manganum Metallicum, Intestine (Suis), Lung (Suis), Cysteinum, Manganese Gluconate, alpha-Ketoglutaricum Acidum, Arsenicum Album, Calcarea Carbonica, Fumaricum Acidum, Natrum Oxalaceticum, Phosphorus LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. GERMANIUM SESQUIOXIDE; COPPER; MANGANESE; PORK INTESTINE; SUS SCROFA LUNG; CYSTEINE; MANGANESE GLUCONATE; OXOGLURIC ACID; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FUMARIC ACID; SODIUM DIETHYL OXALACETATE; PHOSPHORUS 8; 8; 8; 8; 8; 9; 10; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0373_0fce7d5a-e181-4c91-b1a1-fae6bed48a3e 43857-0373 HUMAN OTC DRUG Thuja Occidentalis Thuja Occidentalis LIQUID ORAL 20150723 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. THUJA OCCIDENTALIS LEAFY TWIG 12 [hp_X]/mL N 20181231 43857-0374_b3eba646-b09e-4e70-b700-256f0dc4df7a 43857-0374 HUMAN OTC DRUG Amoebatox Triticum Aestivum, Baptisia Tinctoria, Capsicum Annuum, Frasera Caroliniensis, Hamamelis Virginiana, Hydrastis Canadensis, Quassia Amara, Senna, Hepar Bovine, Pancreas Suis, Spleen (Bovine), Belladonna, Cinchona Officinalis, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Amoeba Axis, Giardia Lamblia LIQUID ORAL 20150728 20200826 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRITICUM AESTIVUM WHOLE; BAPTISIA TINCTORIA ROOT; CAPSICUM; FRASERA CAROLINIENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; GOLDENSEAL; QUASSIA AMARA WOOD; SENNA LEAF; BEEF LIVER; SUS SCROFA PANCREAS; BOS TAURUS SPLEEN; ATROPA BELLADONNA WHOLE; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; AMOEBA PROTEUS; GIARDIA LAMBLIA 1; 3; 3; 3; 3; 3; 3; 3; 8; 8; 8; 12; 12; 12; 12; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0375_1901b226-17ee-474c-836b-e8b63a3d1cad 43857-0375 HUMAN OTC DRUG Neurotox Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Epstein-Barr Virus Nosode, Gelsemium Sempervirens, Latrodectus Mactans, Morbillinum, Poliomyetilis Virus, Rhus Tox, Tarentula Cubensis, Salmonella Typhi, Lanthanum Metallicum, Clostridium Perfringens, Niobium Metallicum, Tantalum Metallicum, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron LIQUID ORAL 20150812 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMANITA MUSCARIA FRUITING BODY; PROTORTONIA CACTI; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE; HUMAN HERPESVIRUS 4; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LATRODECTUS MACTANS; MEASLES VIRUS; POLIOVIRUS; TOXICODENDRON PUBESCENS LEAF; CITHARACANTHUS SPINICRUS; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; LANTHANUM; CLOSTRIDIUM PERFRINGENS; NIOBIUM; TANTALUM 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 33; 14; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0376_89180ded-82eb-4043-9155-c88c175dabd9 43857-0376 HUMAN OTC DRUG Energy Boldo, Chelidonium Majus, Ginkgo Biloba, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Copper Gluconate, Germanium Sesquioxide LIQUID ORAL 20150812 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; GINKGO; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; COPPER GLUCONATE; GERMANIUM SESQUIOXIDE 3; 3; 3; 3; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0377_10fa1da9-b663-4a73-b89b-87414fc7d1f4 43857-0377 HUMAN OTC DRUG Lym D HP Arsenicum Album, Borrelia Burgdorferi Nosode, Chelidonium Majus, Coccus Cacti, Echinacea (Angustifolia), Hydrastis Canadensis, Lycopodium Clavatum, Nasturtium Aquaticum, Phosphorus, Rhus Tox, Taraxacum Officinale, Thymus (Suis), Thyroidinum (Suis), Trifolium Pratense, Urtica Dioica LIQUID ORAL 20151002 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARSENIC TRIOXIDE; BORRELIA BURGDORFERI; CHELIDONIUM MAJUS; PROTORTONIA CACTI; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; NASTURTIUM OFFICINALE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; TARAXACUM OFFICINALE; SUS SCROFA THYMUS; THYROID, PORCINE; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0378_fb0b3b99-cc39-4abd-bf47-aee381379195 43857-0378 HUMAN OTC DRUG Cough Syrup Formula Drosera (Rotundifolia), Coccus Cacti, Spongia Tosta, Belladonna, Cuprum Aceticum, Kali Carbonicum, Mentha Piperita, Phosphorus LIQUID ORAL 20150929 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. DROSERA ROTUNDIFOLIA; PROTORTONIA CACTI; SPONGIA OFFICINALIS SKELETON, ROASTED; ATROPA BELLADONNA; CUPRIC ACETATE; POTASSIUM CARBONATE; MENTHA PIPERITA; PHOSPHORUS 3; 5; 5; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0379_ddf1094a-496d-4e10-b5aa-67a70cc0cf92 43857-0379 HUMAN OTC DRUG Somineze Humulus Lupulus, Passiflora Incarnata, Valeriana Officinalis, Ambrosia Artemisiaefolia, Arsenicum Album, Coffea Tosta, Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Silicea LIQUID ORAL 20151014 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HOPS; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; COFFEA ARABICA SEED, ROASTED; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; SILICON DIOXIDE 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0380_1cfc7029-0624-4041-8462-ba109d79e821 43857-0380 HUMAN OTC DRUG Renotox Triticum Aestivum, Asparagus Officinalis, Barosma (Betulina), Berberis Vulgaris, Echinacea (Angustifolia), Kali Muriaticum, Petroselinum Sativum, Sabal Serrulata, Solidago Virgaurea, Taraxacum Officinale, Uva-Ursi, Eupatorium Purpureum, Kidney (suis), Bryonia (Alba), Mercurius Corrosivus, Epstein-Barr Virus Nosode, Influenzinum, Morbillinum, Poliomyelitis Nosode, Salmonella Typhi Nosode, Clostridium Perfringens, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album LIQUID ORAL 20151019 20201111 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRITICUM AESTIVUM WHOLE; ASPARAGUS; AGATHOSMA BETULINA LEAF; BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; POTASSIUM CHLORIDE; PETROSELINUM CRISPUM; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF; EUTROCHIUM PURPUREUM ROOT; PORK KIDNEY; BRYONIA ALBA ROOT; MERCURIC CHLORIDE; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; HUMAN HERPESVIRUS 4; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; POLIOVIRUS; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; LANTHANUM; CLOSTRIDIUM PERFRINGENS; NIOBIUM; TANTALUM 1; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 33; 14; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0381_074e4da3-ca01-42b0-88da-a2a0da804fd1 43857-0381 HUMAN OTC DRUG Neuralgia HP Agaricus Muscarius, Allium Cepa, Arnica Montana, Hypericum Perforatum, Lycopodium Clavatum, Mercurius Solubilis, Phosphorus, Plumbum Metallicum LIQUID ORAL 20151020 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMANITA MUSCARIA FRUITING BODY; ONION; ARNICA MONTANA; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; LEAD 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0382_b3ddb785-4aa5-4232-ad0e-107bca214160 43857-0382 HUMAN OTC DRUG Rheumatic Tonic I Ginkgo Biloba, Dioscorea Villosa, Glycyrrhiza Glabra, Viscum Album, Pinus Sylvestris, Apis Mellifica, Dulcamara, Kalmia Latifolia, Lycopodium Clavatum, Sulphur LIQUID ORAL 20151111 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. GINKGO; DIOSCOREA VILLOSA TUBER; GLYCYRRHIZA GLABRA; VISCUM ALBUM FRUITING TOP; PINUS SYLVESTRIS LEAFY TWIG; APIS MELLIFERA; SOLANUM DULCAMARA TOP; KALMIA LATIFOLIA LEAF; LYCOPODIUM CLAVATUM SPORE; SULFUR 1; 1; 3; 3; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0383_525004b4-0ff5-48d5-96ee-182bd8ba268f 43857-0383 HUMAN OTC DRUG Ginkgo Tonic Aralia Quinquefolia, Ginkgo Biloba, Hydrocotyle Asiatica, Polygonum Multiflorum, Aronia Melanocarpa, Vaccinium Myrtillus, Germanium Sesquioxide, Aurum Metallicum, Baryta Muriatica, Kali Phosphoricum, Plumbum Metallicum, Secale Cornutum, Tabacum, Viscum Album, Ubidecarenonum, Adenosinum Triphosphoricum Dinatrum LIQUID ORAL 20151130 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; GINKGO; CENTELLA ASIATICA; FALLOPIA MULTIFLORA ROOT; ARONIA MELANOCARPA FRUIT; BILBERRY; GERMANIUM SESQUIOXIDE; GOLD; BARIUM CHLORIDE DIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; LEAD; CLAVICEPS PURPUREA SCLEROTIUM; TOBACCO LEAF; VISCUM ALBUM FRUITING TOP; UBIDECARENONE; ADENOSINE TRIPHOSPHATE DISODIUM 1; 1; 1; 1; 3; 3; 8; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0384_6a041cb8-54d0-4650-9dbc-92a7ca74a0cd 43857-0384 HUMAN OTC DRUG Lipotox Squalene, Cholesterinum, Estradiol, Progesterone, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methyl Paraben, Propyl Paraben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum, Arsenicum Album, Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Aceticum Acidum, Adrenocorticotrophin, Benzoicum Acidum, Benzyl Alcohol, Boricum Acidum, Chlorinum, Cortisone Aceticum, Eugenol, Folliculinum, Isopropyl Palmitate, Lacticum Acidum, Petroleum Jelly LIQUID ORAL 20160111 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SQUALENE; CHOLESTEROL; ESTRADIOL; PROGESTERONE; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; ANHYDROUS TRISODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; ACETIC ACID; CORTICOTROPIN; BENZOIC ACID; BENZYL ALCOHOL; BORIC ACID; CHLORINE; CORTISONE ACETATE; EUGENOL; ESTRONE; ISOPROPYL ALCOHOL; LACTIC ACID, DL-; PETROLATUM; PHENYLBUTAZONE; LEAD; POTASSIUM SORBATE; RESORCINOL; SALICYLIC ACID; SORBITOL; STEARYL ALCOHOL; XYLITOL 8; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0385_661184be-8421-4d7b-a1b8-eaff0c352b74 43857-0385 HUMAN OTC DRUG Influaforce Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Propolis, Bryonia (Alba), Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Ipecacuanha, Mercurius Corrosivus, Pyrogenium, Influenzinum LIQUID ORAL 20160121 20210209 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; PROPOLIS WAX; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; MERCURIC CHLORIDE; RANCID BEEF; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 30; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0386_a677a213-3902-4589-a5f7-8b603bcc776e 43857-0386 HUMAN OTC DRUG VAX Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Tabebuia Impetiginosa, Trifolium Pratense, Arnica Montana, Calendula Officinalis, Chelidonium Majus, Leptandra Virginica, Ligusticum Porteri, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Taraxacum Officinale, Trigonella Foenum-Graecum, Urtica Dioica, Astragalus Membranaceus, Propolis, Glandula Suprarenalis Suis, Thymus (Suis), Arsenicum Album, Belladonna, Chamomilla, Lycopodium Clavatum, Rhus Tox, Silicea, LIQUID ORAL 20160121 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; TABEBUIA IMPETIGINOSA BARK; TRIFOLIUM PRATENSE FLOWER; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM AQUATICUM; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; FENUGREEK SEED; URTICA DIOICA; ASTRAGALUS PROPINQUUS ROOT; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; ANTIMONY TRISULFIDE; BORDETELLA PERTUSSIS; TETANUS TOXIN; THIMEROSAL 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 6; 6; 8; 8; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0388_169f273a-a44f-4b22-837a-3192b00c7be5 43857-0388 HUMAN OTC DRUG Lymph III Echinacea (Angustifolia), Phytolacca Decandra, Boldo, Pinus Sylvestris, Thyroidinum (Suis), Germanium Sesquioxide, Arnica Montana, Calcarea Iodata, Hamamelis Virginiana, Hepar Sulphuris Calcareum, Adenosinum Triphosphoricum, Dinatrum, Ubidecarenonum, Naja Tripudians, Calcarea Phosphorica, Influenzinum (2015-2016), Natrum Sulphuricum, Pyrogenium, Sulphur, Carcinosin LIQUID ORAL 20160412 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; PEUMUS BOLDUS LEAF; PINUS SYLVESTRIS LEAFY TWIG; THYROID, PORCINE; GERMANIUM SESQUIOXIDE; ARNICA MONTANA; CALCIUM IODIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; ADENOSINE TRIPHOSPHATE DISODIUM; UBIDECARENONE; NAJA NAJA VENOM; TRIBASIC CALCIUM PHOSPHATE; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); SODIUM SULFATE; RANCID BEEF; SULFUR; HUMAN BREAST TUMOR CELL 1; 3; 3; 6; 6; 8; 12; 12; 12; 12; 12; 12; 15; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0389_fba014b3-00a5-4408-8ddd-be4fe272ed87 43857-0389 HUMAN OTC DRUG Grain and Seed Antigens Bamboo, Barley, California Poppy, Corn, Flax, Levant Cotton, Millet, Milo, Oat, Rice, Rye, Safflower, Sesame, Sorghum, Soy Bean, Sugarcane, Sunflower, Wheat, Arsenicum Album, Lycopodium Clavatum, Natrum Muriaticum, Sulphur LIQUID ORAL 20160422 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAMBUSA VULGARIS LEAF; BARLEY; ESCHSCHOLZIA CALIFORNICA; CORN; FLAX SEED; LEVANT COTTON SEED; MILLET; SORGHUM BICOLOR WHOLE; OAT; BROWN RICE; RYE; SAFFLOWER; SESAME SEED; SOYBEAN; SUGARCANE; SUNFLOWER SEED; WHEAT; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SULFUR 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0390_5cf8582b-628f-4247-ada6-068e8722dc77 43857-0390 HUMAN OTC DRUG Bio Cerato Cerato LIQUID ORAL 20160502 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CERATOSTIGMA WILLMOTTIANUM FLOWER 6 [hp_X]/mL N 20181231 43857-0391_b3a947ae-ea12-43e2-8cba-ca36584fb298 43857-0391 HUMAN OTC DRUG CVTOX Cochlearia Armoracia, Echinacea (Angustifolia), Lomatium Dissectum, Tabebuia Impetiginosa, Hydrastis Canadensis, Propolis, Glandula Suprarenalis Bovine, Thymus (Suis), Aranea Diadema, Ipecacuanha, Lycopodium Clavatum, Muriaticum Acidum, Nitricum Acidum, Phosphoricum Acidum, Rhus Tox, Silicea, Cytomegalovirus Nosode, Epstein-Barr Virus Nosode, Herpes Zoster Nosode, Morbillinum, Poliomyelitis Nosode, Hepatitis B Nosode, Coxsackie B1 Nosode, Coxsackie B4 Nosode LIQUID ORAL 20160502 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HORSERADISH; ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; PROPOLIS WAX; BOS TAURUS ADRENAL GLAND; SUS SCROFA THYMUS; ARANEUS DIADEMATUS; IPECAC; LYCOPODIUM CLAVATUM SPORE; HYDROCHLORIC ACID; NITRIC ACID; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; HUMAN HERPESVIRUS 5; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 3; MEASLES VIRUS; POLIOVIRUS; HEPATITIS B VIRUS; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4 3; 3; 3; 3; 5; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 33; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0392_863a9d6e-f34f-4e12-8fcb-70c481b0f9f4 43857-0392 HUMAN OTC DRUG Prostatone HP Clematis Erecta, Conium Maculatum, Lycopodium Clavatum, Mercurius Corrosivus, Pulsatilla (Vulgaris), Sabal Serrulata, Selenium Metallicum, Sepia, Staphysagria, Thuja Occidentalis LIQUID ORAL 20160426 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0393_96ac2476-8b84-45ea-af43-c6f0c6f02da0 43857-0393 HUMAN OTC DRUG EVTOX Cochlearia Officinalis, Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Tabebuia Impetiginosa, Propolis, Glandula Suprarenalis Suis, Thymus (Suis), Aranea Diadema, Ipecacuanha, Lycopodium Clavatum, Muriaticum Acidum, Nitricum Acidum, Rhus Tox, Silicea, EBV Nosode, LIQUID ORAL 20160503 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. COCHLEARIA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; ARANEUS DIADEMATUS; IPECAC; LYCOPODIUM CLAVATUM SPORE; HYDROCHLORIC ACID; NITRIC ACID; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; HUMAN HERPESVIRUS 4 3; 3; 3; 3; 5; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0394_18509fe8-e3b9-4ed2-a15d-795e1a97a6fa 43857-0394 HUMAN OTC DRUG Influaforce Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Propolis, Bryonia (Alba), Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Ipecacuanha, Mercurius Corrosivus, Pyrogenium, Influenzinum LIQUID ORAL 20160503 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; PROPOLIS WAX; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; MERCURIC CHLORIDE; RANCID BEEF; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 3; 3; 3; 3; 3; 5; 6; 12; 12; 12; 12; 12; 12; 30; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0395_dd5344c1-5a59-416a-bd14-936f7c1c73f4 43857-0395 HUMAN OTC DRUG Edemaforce Cactus Grandiflorus, Calendula Officinalis, Dulcamara, Leptandra Virginica, Solidago Virgaurea, Convallaria Majalis, Apis Mellifica, Arnica Montana, Berberis Vulgaris, Bryonia (Alba), Chelidonium Majus, Lycopodium Clavatum, Plumbum Metallicum, Sambucus Nigra LIQUID ORAL 20160531 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SELENICEREUS GRANDIFLORUS STEM; CALENDULA OFFICINALIS FLOWERING TOP; SOLANUM DULCAMARA TOP; VERONICASTRUM VIRGINICUM ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; CONVALLARIA MAJALIS; APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; LEAD; SAMBUCUS NIGRA FLOWERING TOP 3; 3; 3; 3; 3; 4; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0396_50615e36-20f1-442a-8fa7-6659839ce45c 43857-0396 HUMAN OTC DRUG Arterioforce II Baptisia Tinctoria, Echinacea (Angustifolia), Phytolacca Decandra, Myrrha, Nasturtium Aquaticum, Trigonella Foenum-Graecum, Hydrastis Canadensis, Kali Iodatum, Arnica Montana, Cactus Grandiflorus, Propolis, Baryta Carbonica, Conium Maculatum, Secale Cornutum LIQUID ORAL 20160531 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; MYRRH; NASTURTIUM OFFICINALE; FENUGREEK SEED; GOLDENSEAL; POTASSIUM IODIDE; ARNICA MONTANA; SELENICEREUS GRANDIFLORUS STEM; PROPOLIS WAX; BARIUM CARBONATE; CONIUM MACULATUM FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM 3; 3; 3; 4; 4; 4; 5; 5; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0397_ef9405e7-e527-4971-b16d-9a361158db1b 43857-0397 HUMAN OTC DRUG FNG I Echinacea (Angustifolia), Lomatium Dissectum, Nasturtium Aquaticum, Tabebuia Impetiginosa, Condurango, Ginkgo Biloba, Ligusticum Porteri, Hydrastis Canadensis, Propolis, Glandula Suprarenalis Bovine, Thymus (Bovine), Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Phytolacca Decandra, Sepia, Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Pullularia Pullulans, Rhizopus Nigricans, Torula Cerevisiae LIQUID ORAL 20160614 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; MARSDENIA CONDURANGO BARK; GINKGO; LIGUSTICUM PORTERI ROOT; GOLDENSEAL; ASTRAGALUS PROPINQUUS ROOT; PROPOLIS WAX; BOS TAURUS ADRENAL GLAND; BOS TAURUS THYMUS; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; SACCHAROMYCES CEREVISIAE 3; 3; 3; 3; 4; 4; 4; 5; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0398_0b6d08ad-8853-4053-8171-319d0dace9bc 43857-0398 HUMAN OTC DRUG Cerebraplex Avena Sativa, Capsicum Annuum, Ginkgo Biloba, Hydrocotyle Asiatica, Polygonum Multiflorum, Rosmarinus Officinalis, Vinca Minor, Cerebrum Suis, Baryta Carbonica, Belladonna, Germanium Sesquioxide, Kali Phosphoricum, Stramonium LIQUID ORAL 20160606 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AVENA SATIVA FLOWERING TOP; CAPSICUM; GINKGO; CENTELLA ASIATICA; FALLOPIA MULTIFLORA ROOT; ROSMARINUS OFFICINALIS FLOWERING TOP; VINCA MINOR; SUS SCROFA CEREBRUM; BARIUM CARBONATE; ATROPA BELLADONNA; GERMANIUM SESQUIOXIDE; POTASSIUM PHOSPHATE, DIBASIC; DATURA STRAMONIUM 3; 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0399_5d463bbc-8232-4847-b522-16cf95f91936 43857-0399 HUMAN OTC DRUG Lymph II Echinacea (Angustifolia), Phytolacca Decandra, Collinsonia Canadensis, Kali Iodatum, Pinus Sylvestris, Pix Liquida, Ferrum Phosphoricum, Aesculus Hippocastanum, Baryta Carbonica, Berberis Vulgaris, Bufo Rana, Calcarea Carbonica, Calcarea Phosphorica, Causticum, Hepar Sulphuris Calcareum, Kreosotum, Lycopodium Clavatum, Mercurius Solubilis, Natrum Muriaticum, Nitricum Acidum, Phosphorus, Pulsatilla (Vulgaris), Silicea, Stellaria Media, Sulphur, Terebinthina, Thuja Occidentalis LIQUID ORAL 20160901 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; COLLINSONIA CANADENSIS ROOT; POTASSIUM IODIDE; PINUS SYLVESTRIS LEAFY TWIG; PINE TAR; FERRUM PHOSPHORICUM; HORSE CHESTNUT; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BUFO BUFO CUTANEOUS GLAND; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; CALCIUM SULFIDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE; STELLARIA MEDIA; SULFUR; TURPENTINE OIL; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 6; 6; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0400_fc1801d9-f6c2-4f78-a7ed-174352d381f1 43857-0400 HUMAN OTC DRUG Injury Topical Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Carbo Vegetabilis, Hamamelis Virginiana, Millefolium, Rhus Tox, Ruta Graveolens, Veratrum Album GEL TOPICAL 20160901 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; HYPERICUM PERFORATUM; COMFREY ROOT; BELLIS PERENNIS; ACTIVATED CHARCOAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACHILLEA MILLEFOLIUM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; VERATRUM ALBUM ROOT 1; 1; 3; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 43857-0401_bfa40d2c-0a70-4e9d-bc63-30e13f5d7f9a 43857-0401 HUMAN OTC DRUG LYM D Chelidonium Majus, Echinacea (Angustifolia), Nasturtium Aquaticum, Taraxacum Officinale, Trifolium Pratense, Urtica Dioica, Hydrastis Canadensis, Thymus (Suis), Thyroidinum (Suis), Arsenicum Album, Coccus Cacti, Lycopodium Clavatum, Phosphorus, Rhus Tox, Borrelia Burgdorferi Nosode, Ledum Palustre LIQUID ORAL 20160627 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; NASTURTIUM OFFICINALE; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA; GOLDENSEAL; SUS SCROFA THYMUS; SUS SCROFA THYROID; ARSENIC TRIOXIDE; PROTORTONIA CACTI; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; BORRELIA BURGDORFERI; LEDUM PALUSTRE TWIG 3; 3; 3; 3; 3; 3; 5; 8; 8; 12; 12; 12; 12; 12; 12; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0402_8986d9ac-ea3c-4a42-8eff-9994a983647a 43857-0402 HUMAN OTC DRUG Calciforce Arnica Montana, Chamomilla, Echinacea (Angustifolia), Boron Gluconate, Symphytum Officinale, Calcarea Fluorica, Calcarea Phosphorica, Hekla Lava, Lycopodium Clavatum, Silicea, Calcarea Carbonica LIQUID ORAL 20171004 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; BORON GLUCONATE; COMFREY ROOT; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; HEKLA LAVA; LYCOPODIUM CLAVATUM SPORE; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE 3; 3; 3; 6; 6; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0403_2bb6e247-9000-4e70-97cc-284b9b0e4d24 43857-0403 HUMAN OTC DRUG Renotox Triticum Aestivum, Asparagus Officinalis, Barosma (Betulina), Berberis Vulgaris, Echinacea (Angustifolia), Kali Muriaticum, Petroselinum Sativum, Sabal Serrulata, Solidago Virgaurea, Taraxacum Officinale, Uva-Ursi, Eupatorium Purpureum, Kidney (Suis), Bryonia (Alba), Mercurius Corrosivus, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum LIQUID ORAL 20160707 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. WHEAT; ASPARAGUS; AGATHOSMA BETULINA LEAF; BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; POTASSIUM CHLORIDE; PETROSELINUM CRISPUM; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF; EUPATORIUM PURPUREUM ROOT; PORK KIDNEY; BRYONIA ALBA ROOT; MERCURIUS SOLUBILIS; ALUMINUM; ANTIMONY; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; HUMAN HERPESVIRUS 4; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); MEASLES VIRUS; POLIOVIRUS; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; LANTHANUM; CLOSTRIDIUM PERFRINGENS; NIOBIUM; TANTALUM 1; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 33; 14; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0404_71fc8181-3b75-4c30-be38-a690d1960413 43857-0404 HUMAN OTC DRUG Injury Arnica Montana, Calendula Officinalis, Hypericum Perforatum, Symphytum Officinale, Belladonna, Bellis Perennis, Carbo Vegetabilis, Hamamelis Virginiana, Millefolium, Rhus Tox, Ruta Graveolens, Veratrum Album LIQUID ORAL 20160708 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; COMFREY ROOT; ATROPA BELLADONNA WHOLE; BELLIS PERENNIS; ACTIVATED CHARCOAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACHILLEA MILLEFOLIUM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; VERATRUM ALBUM ROOT 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0405_3077864c-a39b-41dd-92aa-b1511b27ec72 43857-0405 HUMAN OTC DRUG Pneumotox Triticum Aestivum, Alfalfa, Arnica Montana, Asclepias Tuberosa, Chamomilla, Echinacea (Angustifolia), Eucalyptus Globulus, Fucus Vesiculosus, Hordeum Vulgare, Laminaria Digitata, Nasturtium Aquaticum, Plantago Major, Raphanus Sativus, Trifolium Pratense, Trigonella Foenum-Graecum, Symphytum Officinale, Lung (Suis), Oryza Sativa, Silicea, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Arsenicum Album LIQUID ORAL 20160803 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRITICUM AESTIVUM WHOLE; ALFALFA; ARNICA MONTANA; ASCLEPIAS TUBEROSA ROOT; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; EUCALYPTUS GLOBULUS LEAF; FUCUS VESICULOSUS; HORDEUM VULGARE TOP; LAMINARIA DIGITATA; NASTURTIUM OFFICINALE; PLANTAGO MAJOR; RAPHANUS SATIVUS; TRIFOLIUM PRATENSE FLOWER; TRIGONELLA FOENUM-GRAECUM WHOLE; SYMPHYTUM OFFICINALE WHOLE; SUS SCROFA LUNG; ORYZA SATIVA WHOLE; SILICON DIOXIDE; ACETONE; SODIUM TRIPOLYPHOSPHATE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; AMMONIUM CHLORIDE; SODIUM LAURYL SULFATE; TURPENTINE OIL; ARSENIC TRIOXIDE; SODIUM CHLORIDE; NITRIC ACID; OENANTHE AQUATICA FRUIT; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; PARAFFIN; ETHYLENE GLYCOL; PROPYL ALCOHOL; PALMITIC ACID; DIMETHICONE; POLYACRYLIC ACID (8000 MW); GLUTARAL; METHYL METHACRYLATE; ANHYDROUS CITRIC ACID; TARTARIC ACID; ANTHRAQUINONE; HYDROGEN PEROXIDE; GLYCOLIC ACID; AMMONIUM THIOGLYCOLATE; SODIUM CARBONATE; MONOETHANOLAMINE; TOLUENE-2,5-DIAMINE; P-AMINOPHENOL 1; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0406_f00e158b-3a49-4114-a9aa-738ce56d74ad 43857-0406 HUMAN OTC DRUG Teething Arnica Montana, Trifolium Pratense, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Chamomilla, Kreosotum, Silicea LIQUID ORAL 20160727 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; TRIFOLIUM PRATENSE FLOWER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; WOOD CREOSOTE; SILICON DIOXIDE 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0407_4d621a86-10a2-42c0-a778-49968f18d678 43857-0407 HUMAN OTC DRUG Intestaforce Althaea Officinalis, Capsicum Annuum, Foeniculum Vulgare, Symphytum Officinale, Argentum Nitricum, Ferrum Phosphoricum, Magnesia Phosphorica, Mercurius Solubilis LIQUID ORAL 20160811 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALTHAEA OFFICINALIS ROOT; CAPSICUM; FENNEL SEED; COMFREY ROOT; SILVER NITRATE; FERRUM PHOSPHORICUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS 3; 3; 3; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0408_4c5db5f2-f9f0-4d47-b5d8-136cc06a1d3b 43857-0408 HUMAN OTC DRUG Apizelen Alfalfa, Avena Sativa, Chelidonium Majus, Aralia Quinquefolia, Beta Vulgaris, Calendula Officinalis, Echinacea (Angustifolia), Natrum Muriaticum, Oxalis Acetosella, Paloondo, Phytolacca Decandra, Trifolium Pratense, Urtica Dioica, Viscum Album, Cobalt Acetate, Cobalt Gluconate, Copper Gluconate, Cuprum Aceticum, Glutathione, Magnesium Gluconicum Dihydricum, Ganoderma Lucidum, Ubidecarenonum, Argentum Metallicum, Germanium Metallicum LIQUID ORAL 20160727 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; CHELIDONIUM MAJUS; AMERICAN GINSENG; BETA VULGARIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; SODIUM CHLORIDE; OXALIS ACETOSELLA LEAF; LARREA TRIDENTATA LEAF; PHYTOLACCA AMERICANA ROOT; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA; VISCUM ALBUM FRUITING TOP; COBALTOUS ACETATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; CUPRIC ACETATE; GLUTATHIONE; MAGNESIUM GLUCONATE; REISHI; UBIDECARENONE; SILVER; GERMANIUM 1; 1; 1; 2; 2; 2; 2; 2; 2; 2; 2; 2; 2; 2; 3; 3; 3; 3; 3; 3; 5; 5; 8; 8 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0409_345c972f-a337-4356-a950-86d518b34dc7 43857-0409 HUMAN OTC DRUG Amoebatox Triticum Aestivum, Baptisia Tinctoria, Capsicum Annuum, Frasera Caroliniensis, Hamamelis Virginiana, Hydrastis Canadensis, Quassia Amara, Senna, Hydrastis Canadensis, Hepar Bovine, Pancreas Suis, Spleen (Bovine), Belladonna, Cinchona Officinalis, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Entamoeba Histolytica, Giardia Lamblia30 LIQUID ORAL 20160818 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRITICUM AESTIVUM WHOLE; BAPTISIA TINCTORIA ROOT; CAPSICUM; ALPINE STRAWBERRY; FRASERA CAROLINIENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; QUASSIA AMARA WOOD; SENNA LEAF; GOLDENSEAL; BEEF LIVER; SUS SCROFA PANCREAS; BOS TAURUS SPLEEN; ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; ENTAMOEBA HISTOLYTICA; GIARDIA LAMBLIA 1; 3; 3; 3; 3; 3; 3; 3; 5; 8; 8; 8; 12; 12; 12; 12; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0410_8b5b7b18-6359-45d6-9a8f-49574d936835 43857-0410 HUMAN OTC DRUG Bio Walnut Juglans Regia, Flos LIQUID ORAL 20160811 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. JUGLANS REGIA FLOWERING TOP 6 [hp_X]/mL N 20181231 43857-0411_a7622d36-a4c7-40ab-a464-4d57271167cb 43857-0411 HUMAN OTC DRUG Virotox Echinacea (Angustifolia), Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Hydrastis Canadensis, Glandula Suprarenalis Bovine, Thymus (Bovine), Belladonna, Gelsemium Sempervirens, Lycopodium Clavatum, Nux Vomica, Pyrogenium LIQUID ORAL 20160818 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; BOS TAURUS ADRENAL GLAND; BOS TAURUS THYMUS; ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; RANCID BEEF 3; 3; 3; 3; 3; 5; 8; 8; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0412_727ccac0-3f68-41f5-be37-26c5b55fd848 43857-0412 HUMAN OTC DRUG Dopamine Dopamine Hydrochloride LIQUID ORAL 20160816 UNAPPROVED HOMEOPATHIC BioActive Nutritional DOPAMINE HYDROCHLORIDE 6 [hp_X]/mL N 20181231 43857-0413_7c629ce8-9dcb-4750-b23d-d40c12f62954 43857-0413 HUMAN OTC DRUG Enuresis HP Argentum Nitricum, Belladonna, Causticum, Equisetum Hyemale, Kreosotum, Nitricum Acidum, Pulsatilla (Vulgaris), Thuja Occidentalis LIQUID ORAL 20160907 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SILVER NITRATE; ATROPA BELLADONNA; CAUSTICUM; EQUISETUM HYEMALE; WOOD CREOSOTE; NITRIC ACID; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0414_39a9d97f-d917-43e4-9d08-738a4d334f47 43857-0414 HUMAN OTC DRUG Tobaccotox Avena Sativa, Kali Phosphoricum, Cactus Grandiflorus, Daphne Indica, Eucalyptol, Lobelia Inflata, Mentholum, Ignatia Amara, Nux Vomica, Staphysagria, Tabacum, Benzinum, Naphthalinum LIQUID ORAL 20160826 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AVENA SATIVA FLOWERING TOP; DIBASIC POTASSIUM PHOSPHATE; SELENICEREUS GRANDIFLORUS STEM; DAPHNE ODORA BARK; EUCALYPTOL; LOBELIA INFLATA; MENTHOL, UNSPECIFIED FORM; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF; BENZENE; NAPHTHALENE 1; 2; 3; 3; 3; 3; 4; 12; 12; 12; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0415_ad50fc9b-277f-4386-a7f0-b045bb43ea1a 43857-0415 HUMAN OTC DRUG Candida Alb Candida Albicans LIQUID ORAL 20160908 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CANDIDA ALBICANS 100 [hp_X]/mL N 20181231 43857-0416_5fcfeed5-7357-461f-96e0-c8066e1541d9 43857-0416 HUMAN OTC DRUG Tryptophan L-Tryptophan LIQUID ORAL 20160929 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. TRYPTOPHAN 6 [hp_X]/mL N 20181231 43857-0417_6b54713f-6236-46e6-9652-aaffb2715397 43857-0417 HUMAN OTC DRUG Endoplex F Cimicifuga Racemosa, Fucus Vesiculosus, Glycyrrhiza Glabra, Xanthoxylum Fraxineum, Adrenalinum, Cerebrum Suis, Hypophysis Suis, Hypothalamus (Suis), Oophorinum (Suis), Pineal (Suis), Thyroidinum (Suis), Pulsatilla (Vulgaris), Sepia LIQUID ORAL 20160929 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BLACK COHOSH; FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; ZANTHOXYLUM AMERICANUM BARK; EPINEPHRINE; SUS SCROFA CEREBRUM; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PINEAL GLAND; SUS SCROFA THYROID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 3; 3; 3; 3; 8; 8; 8; 8; 8; 8; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0418_00a77fb6-d971-4b37-8d0b-eb11407d7a79 43857-0418 HUMAN OTC DRUG Inflammation II Astragalus Membranaceus, Echinacea (Angustifolia), Sarsaparilla (Smilax Regelii), Tabebuia Impetiginosa, Hydrastis Canadensis, Thyroidinum (Suis), Aurum Metallicum, Carbo Animalis, Causticum, Gelsemium Sempervirens, Natrum Sulphuricum, Phosphorus, Sulphur, Thuja Occidentalis LIQUID ORAL 20161004 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ASTRAGALUS PROPINQUUS ROOT; ECHINACEA ANGUSTIFOLIA; SARSAPARILLA; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; SUS SCROFA THYROID; GOLD; ACTIVATED CHARCOAL; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; SODIUM SULFATE; PHOSPHORUS; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 6; 8; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0419_c25aa586-36af-4605-868a-ddbd81b9c8b9 43857-0419 HUMAN OTC DRUG Sinus Tonic Echinacea (Angustifolia), Baptisia Tinctoria, Thiaminum Hydrochloricum, Hydrastis Canadensis, Pyridoxinum Hydrochloricum, Spongia Tosta, Apis Mellifica, Ascorbic Acid, Hepar Sulphuris Calcareum, Kali Bichromicum, Lachesis Mutus, Mercurius Iodatus Ruber, Mercurius Sulphuratus Ruber, Pulsatilla (Vulgaris), Silicea, Sinusitisinum, Pantothenic Acid LIQUID ORAL 20161028 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; BAPTISIA TINCTORIA ROOT; THIAMINE HYDROCHLORIDE; GOLDENSEAL; PYRIDOXINE HYDROCHLORIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; APIS MELLIFERA; ASCORBIC ACID; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MERCURIC IODIDE; MERCURIC SULFIDE; ANEMONE PULSATILLA; SILICON DIOXIDE; SINUSITISINUM; PANTOTHENIC ACID 1; 3; 4; 5; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 28 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0420_ca94b8ed-f162-4e57-b3e0-eddcaed62b16 43857-0420 HUMAN OTC DRUG BAC Echinacea (Angustifolia), Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Hydrastis Canadensis, Propolis, Glandula Suprarenalis Suis, Lymph Node (Suis), Spleen (Suis), Thymus (Suis), Thyroidinum (Suis), Arsenicum Album, Belladonna, Hypericum Perforatum, Phosphorus, Botulinum, Escherichia Coli, Proteus (Vulgaris), Pseudomonas Aeruginosa, Yersinia Enterocolitica, Salmonella Typhi Nosode, Clostridium Perfringens LIQUID ORAL 20161116 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SUS SCROFA THYROID; ARSENIC TRIOXIDE; ATROPA BELLADONNA; HYPERICUM PERFORATUM; PHOSPHORUS; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; CLOSTRIDIUM PERFRINGENS 3; 3; 3; 3; 3; 5; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12; 30; 30; 30; 30; 30; 33; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0421_6af3fe9c-aa0e-4d2a-a34e-aabc1c03b9aa 43857-0421 HUMAN OTC DRUG Mammaryplex Echinacea (Angustifolia), Myrrha, Phytolacca Decandra, Trigonella Foenum-Graecum, Hydrastis Canadensis, Lymph (Suis), Spleen (Suis), Bryonia (Alba), Bufo Rana, Conium Maculatum, Lac Caninum, Lachesis Mutus, Silicea, Mammary Gland (Bovine) LIQUID ORAL 20161117 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; MYRRH; PHYTOLACCA AMERICANA ROOT; FENUGREEK SEED; GOLDENSEAL; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; BRYONIA ALBA ROOT; BUFO BUFO CUTANEOUS GLAND; CONIUM MACULATUM FLOWERING TOP; CANIS LUPUS FAMILIARIS MILK; LACHESIS MUTA VENOM; SILICON DIOXIDE; BOS TAURUS MAMMARY GLAND 3; 3; 3; 3; 5; 8; 8; 12; 12; 12; 12; 12; 12; 36 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0423_16c3f9d0-7560-4921-80ee-112fd381f69d 43857-0423 HUMAN OTC DRUG Sinuforce Echinacea (Angustifolia), Nux Moschata, Trigonella Foenum Graecum, Hydrastis Canadensis, Arsenicum Album, Kali Bichromicum, Mercurius Sulphuratus Ruber, Pulsatilla (Vulgaris), Sepia, Mercurius Solubilis LIQUID ORAL 20170104 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; NUTMEG; FENUGREEK SEED; GOLDENSEAL; ARSENIC TRIOXIDE; POTASSIUM DICHROMATE; MERCURIC SULFIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; MERCURIUS SOLUBILIS 3; 3; 3; 5; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0424_4e8887a0-b21d-4480-9c5f-ee239a75f7fd 43857-0424 HUMAN OTC DRUG FNG II Echinacea (Angustifolia), Lomatium Dissectum, Nasturtium Aquaticum, Tabebuia Impetiginosa, Hydrastis Canadensis, Iodium, Adrenalinum, Argentum Metallicum, Thymus (Suis), Thyroidinum (Suis), Phosphoricum Acidum, Candida Albicans, Lycopodium Clavatum, Pulsatilla (Vulgaris), Sepia LIQUID ORAL 20161220 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; IODINE; EPINEPHRINE; SILVER; SUS SCROFA THYMUS; SUS SCROFA THYROID; PHOSPHORIC ACID; CANDIDA ALBICANS; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 3; 3; 3; 3; 5; 6; 8; 8; 8; 8; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0425_96cfead1-a1ea-4953-aea8-fd9ca2ff0435 43857-0425 HUMAN OTC DRUG Cesium Chloride Cesium Chloride LIQUID ORAL 20170119 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CESIUM CHLORIDE 6 [hp_X]/mL N 20181231 43857-0426_dfba619a-b9de-4457-b7f9-fc20cd2e7640 43857-0426 HUMAN OTC DRUG ASP Echinacea (Angustifolia), Tabebuia Impetiginosa, Hydrastis Canadensis, Glandula Suprarenalis Suis, Thymus (Suis), Thyroidinum (Suis), Arsenicum Album, Bryonia (Alba), Cocculus Indicus, Colchicum Autumnale, Ledum Palustre, Mercurius Cyanatus, Natrum Sulphuricum, Pulsatilla (Vulgaris) Sepia, Silicea, Aspergillus Flavus LIQUID ORAL 20170124 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; HANDROANTHUS IMPETIGINOSUS BARK; GOLDENSEAL; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; LEDUM PALUSTRE TWIG; MERCURIC CYANIDE; SODIUM SULFATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; ASPERGILLUS FLAVUS 3; 3; 5; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0427_824320d4-43c6-41e8-9536-58b4a1c3f7e0 43857-0427 HUMAN OTC DRUG Pacreaplex Chelidonium Majus, Glycyrrhiza Glabra, Nux Moschata, Rheum (Officinale), Syzygium Jambolanum, Taraxacum Officinale, Zingiber Officinale, Hydrastis Canadensis, Glandula Suprarenalis Suis, Hepar Suis, Hypophysis Suis, Pancreas Suis, Thyroidinum (Suis), Phaseolus, Phosphoricum Acidum, Phosphorus LIQUID ORAL 20170124 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; GLYCYRRHIZA GLABRA; NUTMEG; RHEUM OFFICINALE ROOT; SYZYGIUM CUMINI SEED; TARAXACUM OFFICINALE; GINGER; GOLDENSEAL; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA PANCREAS; SUS SCROFA THYROID; KIDNEY BEAN; PHOSPHORIC ACID; PHOSPHORUS 3; 3; 3; 3; 3; 3; 3; 5; 6; 6; 6; 6; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0428_6611f777-ac10-4c17-bc9b-cde79ad86091 43857-0428 HUMAN OTC DRUG Strength M Aralia Quinquefolia, Avena Sativa, Damiana, Epimedium Grandiflorum, Glutathione, L-Arginine, L-Leucine, L-Ornithine, L-Valine, Testosterone, Sabal Serrulata, Sepia LIQUID ORAL 20170119 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; TURNERA DIFFUSA LEAFY TWIG; EPIMEDIUM GRANDIFLORUM TOP; GLUTATHIONE; ARGININE; LEUCINE; ORNITHINE; VALINE; TESTOSTERONE; SAW PALMETTO; SEPIA OFFICINALIS JUICE 3; 3; 3; 6; 6; 6; 6; 6; 6; 12; 24; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0429_e56f783d-eaf5-40a1-9eb5-81ea905d1e00 43857-0429 HUMAN OTC DRUG Neurotox Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum LIQUID ORAL 20170207 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. AMANITA MUSCARIA FRUITING BODY; PROTORTONIA CACTI; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE; HUMAN HERPESVIRUS 4; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); LATRODECTUS MACTANS; MEASLES VIRUS; POLIOVIRUS; TOXICODENDRON PUBESCENS LEAF; CITHARACANTHUS SPINICRUS; CLOSTRIDIUM BOTULINUM; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; LANTHANUM; CLOSTRIDIUM PERFRINGENS; NIOBIUM 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 33; 14; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0430_68ac5577-0376-4257-8153-e092e80bd70e 43857-0430 HUMAN OTC DRUG Osteoplex Equisetum Hyemale, Magnesia Muriatica, Ascorbic Acid, Manganum Muriaticum, Symphytum Officinale, Medulla Ossis Suis, Calcarea Fluorica, Calcarea Phosphorica, Silicea, Ligament (Suis), Parathyroid (Suis) LIQUID ORAL 20170207 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. EQUISETUM HYEMALE; MAGNESIUM CHLORIDE; ASCORBIC ACID; COMFREY ROOT; MANGANESE CHLORIDE; SUS SCROFA BONE MARROW; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; SILICON DIOXIDE; SUS SCROFA LIGAMENT; SUS SCROFA PARATHYROID GLAND 3; 3; 6; 6; 6; 8; 12; 12; 12; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0431_4bcf1dd2-ea2d-4796-8663-294dcb21297b 43857-0431 HUMAN OTC DRUG Oligo Bio Iodine Chelidonium Majus, Spongia Tosta, Iodium, Lycopus Virginicus, Ginkgo Biloba, Pinus Sylvestris, Fucus Vesiculosus, Germanium Sesquioxide, Hypophysis Suis, Thyroidinum (Suis), Cysteinum, Manganese Gluconate, Alpha-Ketoglutaricum Acidum, Calcarea Carbonica, Ferrum Iodatum, Fumaricum Acidum, Kali Iodatum, Natrum Oxalaceticum, Pulsatilla (Vulgaris), Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Eugenol, Formalinum, Lidocaine, Mercurius Solubilis, Molybdenum Metallicum, Niccolum Metallicum LIQUID ORAL 20170804 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; SPONGIA OFFICINALIS SKELETON, ROASTED; IODINE; LYCOPUS VIRGINICUS; GINKGO; PINUS SYLVESTRIS LEAFY TWIG; FUCUS VESICULOSUS; GERMANIUM SESQUIOXIDE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; CYSTEINE; MANGANESE GLUCONATE; OXOGLURIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; FUMARIC ACID; POTASSIUM IODIDE; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; SILVER; GOLD; COPPER; EUGENOL; FORMALDEHYDE; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; TIN; TITANIUM; ZINC; RUBELLA VIRUS; MUMPS VIRUS; HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B3; HUMAN COXSACKIEVIRUS B4 3; 3; 4; 4; 6; 6; 6; 8; 8; 8; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 16; 16; 16; 16; 16 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0432_939a35b6-dfee-449c-bee3-2ef6351de8d1 43857-0432 HUMAN OTC DRUG Prostatone Echinacea (Angustifolia), Phytolacca Decandra, Sabal Serrulata, Sarsaparilla (Smilax Regelii), Solidago Virgaurea, Zincum Sulphuricum, Hydrastis Canadensis, Orchitinum (Suis), Prostate (Suis), Clematis Erecta, Phosphoricum Acidum, Pulsatilla (Vulgaris) LIQUID ORAL 20170214 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; SAW PALMETTO; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; ZINC SULFATE HEPTAHYDRATE; GOLDENSEAL; SUS SCROFA TESTICLE; SUS SCROFA PROSTATE; CLEMATIS RECTA FLOWERING TOP; PHOSPHORIC ACID; PULSATILLA VULGARIS 3; 3; 3; 3; 3; 3; 5; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0433_72cf01a2-c97e-4835-96c4-a4acf5126c18 43857-0433 HUMAN OTC DRUG Arrhythmiaforce Juglans Nigra, Leonurus Cardiaca, Adonis Vernalis, Convallaria Majalis, Magnesia Sulphurica, Kali Chloricum, Digitalis Purpurea, Lycopus Virginicus, Phosphorus LIQUID ORAL 20170228 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BLACK WALNUT; LEONURUS CARDIACA; ADONIS VERNALIS; CONVALLARIA MAJALIS; MAGNESIUM SULFATE HEPTAHYDRATE; POTASSIUM CHLORATE; IBERIS AMARA SEED; DIGITALIS; LYCOPUS VIRGINICUS; PHOSPHORUS 3; 3; 4; 4; 4; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0434_fa1aa211-2180-4e63-a986-a3e4760685bc 43857-0434 HUMAN OTC DRUG Lumbagoforce Arnica Montana, Hypericum Perforatum, Gnaphalium Polycephalum, Symphytum Officinale, Colocynthis, Formica Rufa, Rhus Tox LIQUID ORAL 20170301 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; HYPERICUM PERFORATUM; PSEUDOGNAPHALIUM OBTUSIFOLIUM; COMFREY ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; FORMICA RUFA; TOXICODENDRON PUBESCENS LEAF 3; 3; 5; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0435_24d18fa7-be88-4cc9-9797-5c550d4a4dcd 43857-0435 HUMAN OTC DRUG Systemic Detox Berberis Vulgaris, Boldo, Chelidonium Majus, Lappa Major, Taraxacum Officinale, Trifolium Pratense, Hydrastis Canadensis, Condurango, Ginkgo Biloba, Tabebuia Impetiginosa, Conium Maculatum, Hepar Sulphuris Calcareum, Lycopodium Clavatum, Sarsaparilla (Smilax Regelii), Aloe, Echinacea (Angustifolia), Natrum Sulphuricum, Nux Vomica, Thuja Occidentalis LIQUID ORAL 20170301 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; ARCTIUM LAPPA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; GOLDENSEAL; MARSDENIA CONDURANGO BARK; GINKGO; TABEBUIA IMPETIGINOSA BARK; CONIUM MACULATUM FLOWERING TOP; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; SMILAX REGELII ROOT; ALOE; ECHINACEA ANGUSTIFOLIA; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 3; 3; 5; 6; 6; 6; 12; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0436_b0407a55-0e26-43ea-ac47-8d3915722a95 43857-0436 HUMAN OTC DRUG Lymph III Echinacea (Angustifolia), Phytolacca Decandra, Boldo, Pinus Sylvestris, Thyroidinum (Suis), Germanium Sesquioxide, Arnica Montana, Calcarea Iodata, Hamamelis Virginiana, Hepar Sulphuris Calcareum, ATP (Adenosine Triphosphate Disodium), Co-Enzyme Q-10, Naja Tripudians, Calcarea Phosphorica, Influenzinum, Natrum Sulphuricum, Pyrogenium, Sulphur, Carcinosin LIQUID ORAL 20170302 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; PEUMUS BOLDUS LEAF; PINUS SYLVESTRIS LEAFY TWIG; SUS SCROFA THYROID; GERMANIUM SESQUIOXIDE; ARNICA MONTANA; CALCIUM IODIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; ADENOSINE TRIPHOSPHATE DISODIUM; UBIDECARENONE; NAJA NAJA VENOM; TRIBASIC CALCIUM PHOSPHATE; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); SODIUM SULFATE; RANCID BEEF; SULFUR; HUMAN BREAST TUMOR CELL 1; 3; 3; 6; 6; 8; 12; 12; 12; 12; 12; 12; 15; 30; 30; 30; 30; 30; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0437_ed9a2948-e84d-4aae-ba4d-edaa28909969 43857-0437 HUMAN OTC DRUG Cardioforce II Abrotanum, Boldo, Cimicifuga Racemosa, Kali Phosphoricum, Taraxacum Officinale, Convallaria Majalis, Magnesia Sulphurica, Oleander, Natrum Muriaticum, Bellis Perennis LIQUID ORAL 20170302 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARTEMISIA ABROTANUM FLOWERING TOP; PEUMUS BOLDUS LEAF; BLACK COHOSH; POTASSIUM PHOSPHATE, DIBASIC; TARAXACUM OFFICINALE; CONVALLARIA MAJALIS; MAGNESIUM SULFATE HEPTAHYDRATE; NERIUM OLEANDER LEAF; SODIUM CHLORIDE; BELLIS PERENNIS 3; 3; 3; 3; 3; 4; 5; 8; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0438_10fd5b19-9aa0-4bae-9d42-299b1cae89cf 43857-0438 HUMAN OTC DRUG Bio Chestnut Bud Aesculus Hippocastanum Flower, Aesculus Hippocastanum Leaf LIQUID ORAL 20170302 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc AESCULUS HIPPOCASTANUM FLOWER; AESCULUS HIPPOCASTANUM LEAF 6; 6 [hp_X]/mL; [hp_X]/mL N 20181231 43857-0439_5e3a9bf0-5d17-46f8-a181-948c4f3f3113 43857-0439 HUMAN OTC DRUG Phenylalanine L-Phenylalanine LIQUID ORAL 20170309 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. PHENYLALANINE 6 [hp_X]/mL N 20181231 43857-0440_709a1c7e-6f6c-4f95-bb33-077d6a26696c 43857-0440 HUMAN OTC DRUG Rheumaforce Chondrus Crispus, Cimicifuga Racemosa, Spiraea Ulmaria, Trifolium Pratense, Urtica Urens, Xanthoxylum Fraxineum, Symphytum Officinale, Colchicum Autumnale, Ferrum Phosphoricum, Formica Rufa, Lithium Carbonicum, Natrum Sulphuricum, Rhododendron Chrysanthemum, Rhus Tox LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHONDRUS CRISPUS; BLACK COHOSH; FILIPENDULA ULMARIA ROOT; TRIFOLIUM PRATENSE FLOWER; URTICA URENS; ZANTHOXYLUM AMERICANUM BARK; COMFREY ROOT; COLCHICUM AUTUMNALE BULB; FERROSOFERRIC PHOSPHATE; FORMICA RUFA; LITHIUM CARBONATE; SODIUM SULFATE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0441_0e49f620-f753-4c59-9ef0-e4ce5fbf703c 43857-0441 HUMAN OTC DRUG Hayfever Tonic Echinacea Purpurea, Hydrastis Canadensis, Eupatorium Perfoliatum, Verbascum Thapsus, Alfalfa, American Elm, Platanus, Fraxinus Americana, Fagus Sylvatica, Flos, Black Walnut, Salix Nigra, Negundo, Eastern Cottonwood, False Ragweed, Giant Ragweed, Solidago Virguarea, Kentucky Bluegrass, Orchard Grass, Red Birch, Trifolium Pratense, Red Oak, Redtop Grass, Hickory, Rumex Acetosa, Ambrosia Artemesiafolia, Timothy Grass, Western Ragweed, Rumex Crispus, Ailanthus Glandulosus, Allium Cepa, Aurum Muriaticum LIQUID ORAL 20170517 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA PURPUREA; EUPATORIUM PERFOLIATUM FLOWERING TOP; VERBASCUM THAPSUS; GOLDENSEAL; ALFALFA; ULMUS AMERICANA POLLEN; ACER PSEUDOPLATANUS POLLEN; FRAXINUS AMERICANA POLLEN; FAGUS SYLVATICA FLOWERING TOP; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA TRIFIDA POLLEN; SOLIDAGO VIRGAUREA POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; BETULA OCCIDENTALIS POLLEN; TRIFOLIUM PRATENSE POLLEN; QUERCUS RUBRA POLLEN; AGROSTIS GIGANTEA POLLEN; CARYA OVATA POLLEN; RUMEX ACETOSELLA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX CRISPUS POLLEN; AILANTHUS ALTISSIMA POLLEN; ONION; GOLD TRICHLORIDE; CAMPHOR (NATURAL); IPECAC; POTASSIUM DICHROMATE; SOLIDAGO VIRGAUREA FLOWERING TOP 1; 1; 3; 5; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0442_c65f863e-ea55-471f-9079-58f05faf3d03 43857-0442 HUMAN OTC DRUG Cardioforce I Arnica Montana, Cactus Grandiflorus, Capsicum Annuum, Digitalis Purpurea, Kali Phosphoricum, Laurocerasus, Spigelia Anthelmia, Tabacum, Aconitum Napellus, Agaricus Muscarius, Aurum Muriaticum, Glonoinum, Ignatia Amara, Kalmia Latifolia, Latrodectus Mactans, Valeriana Officinalis LIQUID ORAL 20170508 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ARNICA MONTANA; SELENICEREUS GRANDIFLORUS STEM; CAPSICUM; DIGITALIS; POTASSIUM PHOSPHATE, DIBASIC; PRUNUS LAUROCERASUS LEAF; SPIGELIA ANTHELMIA; TOBACCO LEAF; ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; GOLD TRICHLORIDE; NITROGLYCERIN; STRYCHNOS IGNATII SEED; KALMIA LATIFOLIA LEAF; LATRODECTUS MACTANS; VALERIAN 3; 3; 3; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0443_48319020-ddf2-4486-85e5-4053bbb277a7 43857-0443 HUMAN OTC DRUG Bio Myelin Protein Cerebrum Suis SPRAY ORAL 20170519 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SUS SCROFA CEREBRUM 6 [hp_X]/mL N 20181231 43857-0445_9bef88c5-2977-4c39-b0f8-8f04e6ceb1c6 43857-0445 HUMAN OTC DRUG Metabolism Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Rhamnus Purshiana, Trifolium Pratense, Xanthoxylum Fraxineum, Ascorbic Acid, Cyanocobalamin, Riboflavinum, Thiaminum Hydrochloricum, Germanium Sesquioxide, Cysteinum, Manganese Gluconate, Adenosinum Triphosphoricum Dinatrum, alpha-Ketoglutaricum Acidum, Fumaricum Acidum, Magnesia Phosphorica, Natrum Oxalaceticum, Pulsatilla (Vulgaris), Pyruvic Acid, Ubidecarenonum, Hepar Sulphuris Calcareum LIQUID ORAL 20170518 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; FRANGULA PURSHIANA BARK; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ASCORBIC ACID; CYANOCOBALAMIN; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; GERMANIUM SESQUIOXIDE; CYSTEINE; MANGANESE GLUCONATE; ADENOSINE TRIPHOSPHATE DISODIUM; .ALPHA.-KETOGLUTARIC ACID; FUMARIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; PYRUVIC ACID; UBIDECARENONE; CALCIUM SULFIDE 3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 8; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0446_551bbf17-56e6-4197-aa31-7539ea5f3b87 43857-0446 HUMAN OTC DRUG Menopause Angelica Archangelica, Aralia Quinquefolia, Cimicifuga Racemosa, Hydrastis Canadensis, Pulsatilla, Sabina, Sepia, Sulphuricum Acidum, Lachesis Mutus LIQUID ORAL 20170518 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ANGELICA ARCHANGELICA ROOT; AMERICAN GINSENG; BLACK COHOSH; GOLDENSEAL; ANEMONE PULSATILLA; JUNIPERUS SABINA LEAFY TWIG; SEPIA OFFICINALIS JUICE; SULFURIC ACID; LACHESIS MUTA VENOM 3; 3; 3; 5; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0447_562a6e71-7273-4b9f-a4da-d6998baff786 43857-0447 HUMAN OTC DRUG Teething-HP Borax, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Passiflora Incarnata, Podophyllinum, Silicea LIQUID ORAL 20170616 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA; PASSIFLORA INCARNATA FLOWERING TOP; PODOPHYLLUM; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0448_cd94bdb5-c37e-47f7-8a65-65d82fdf8040 43857-0448 HUMAN OTC DRUG Rheumatic Tonic II Harpagophytum Procumbens, Symphytum Officinale, Salix Alba, Colchicum Autumnale, Pinus Sylvestris, Aconitum Napellus, Arnica Montana, Gelsemium Sempervirens, Iris Versicolor, Ledum Palustre, Lespedeza Capitata, Rhus Tox, Secale Cornutum, Spigelia Anthelmia, Spiraea Ulmaria, Tartaricum Acidum LIQUID ORAL 20170606 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HARPAGOPHYTUM PROCUMBENS ROOT; SALIX ALBA BARK; COLCHICUM AUTUMNALE BULB; PINUS SYLVESTRIS LEAFY TWIG; COMFREY ROOT; ACONITUM NAPELLUS; ARNICA MONTANA; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; LEDUM PALUSTRE TWIG; LESPEDEZA CAPITATA FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM; SPIGELIA ANTHELMIA; FILIPENDULA ULMARIA ROOT; TARTARIC ACID 1; 1; 3; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0449_e583a652-8ac5-4f04-87fa-1386371fa7e0 43857-0449 HUMAN OTC DRUG Occuloplex I Euphrasia Officinalis, Ginkgo Biloba, Taraxacum Officinale, Hydrastis Canadensis, Beta Carotene, Cyanocobalamin, Glutathione, Ubidecarenonum, Zincum Gluconicum, Citrus Bioflavonoids, Eye (Bovine), Ammonium Muriaticum, Calcarea Fluorica, Causticum, Conium Maculatum, Germanium Sesquioxide, Magnesia Carbonica, Selenium Dioxide, Silicea LIQUID ORAL 20170608 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. EUPHRASIA STRICTA; GINKGO; TARAXACUM OFFICINALE; GOLDENSEAL; .BETA.-CAROTENE; CYANOCOBALAMIN; GLUTATHIONE; UBIDECARENONE; ZINC; CITRUS BIOFLAVONOIDS; BOS TAURUS EYE; AMMONIUM CHLORIDE; CALCIUM CHLORIDE; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; GERMANIUM SESQUIOXIDE; MAGNESIUM CARBONATE; SELENIUM DIOXIDE; SILICON DIOXIDE 3; 3; 3; 5; 6; 6; 6; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0450_1293d52a-ac96-4912-8874-161bac1461af 43857-0450 HUMAN OTC DRUG Bio Red Chestnut Aesculus Carnea, Flos LIQUID ORAL 20170615 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc AESCULUS X CARNEA FLOWER 6 [hp_X]/mL N 20181231 43857-0451_95551b61-d8b5-4487-ac58-b7f368f609a6 43857-0451 HUMAN OTC DRUG Industrotox Glycyrrhiza Glabra, Plantago Major, Stillingia Sylvatica, Trifolium Pratense, Arnica Montana, Asclepias Tuberosa, Berberis Vulgaris, Calendula Officinalis, Chamomilla, Chelidonium Majus, Echinacea (Angustifolia), Eucalyptus Globulus, Lappa Major, Nasturtium Aquaticum, Phytolacca Decandra, Rhamnus Frangula, Rhamnus Purshiana, Taraxacum Officinale, Trigonella Foenum-Graecum, Urtica Dioica, Xanthoxylum Fraxineum, Symphytum Officinale, Hepar Suis, Lung (Suis), Lymph Node (Suis) LIQUID ORAL 20170616 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. GLYCYRRHIZA GLABRA; PLANTAGO MAJOR; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ARNICA MONTANA; ASCLEPIAS TUBEROSA ROOT; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; EUCALYPTUS GLOBULUS LEAF; ARCTIUM LAPPA ROOT; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; FRANGULA PURSHIANA BARK; TARAXACUM OFFICINALE; FENUGREEK SEED; URTICA DIOICA; ZANTHOXYLUM AMERICANUM BARK; COMFREY ROOT; PORK LIVER; SUS SCROFA LUNG; SUS SCROFA LYMPH; ATROPA BELLADONNA; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 6; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0452_029304f4-c605-451c-84ec-d537fa1e016d 43857-0452 HUMAN OTC DRUG Ricetsotox Rickettsia Nosode LIQUID ORAL 20170619 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. RICKETTSIA PROWAZEKII 16 [hp_X]/mL N 20181231 43857-0453_1322732d-5d86-4b79-bd55-91aebccb013d 43857-0453 HUMAN OTC DRUG VAX Baptisia Tinctoria, Echinacea (Angustifolia), Tabebuia Impetiginosa, Trifolium Pratense, Arnica Montana, Calendula Officinalis, Chelidonium Majus, Leptandra Virginica, Ligusticum Porteri, Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Taraxacum Officinale, Trigonella Foenum-Graecum, Urtica Dioica, Hydrastis Canadensis, Astragalus Membranaceus, Propolis, Glandula Suprarenalis Suis, Thymus (Suis), Arsenicum Album, Belladonna, Chamomilla, Lycopodium Clavatum, Rhus Tox, Silicea, LIQUID ORAL 20170720 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA; ECHINACEA ANGUSTIFOLIA; TABEBUIA IMPETIGINOSA BARK; TRIFOLIUM PRATENSE FLOWER; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; LIGUSTICUM PORTERI ROOT; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; FENUGREEK SEED; URTICA DIOICA; GOLDENSEAL; ASTRAGALUS PROPINQUUS ROOT; PROPOLIS WAX; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; ANTIMONY TRISULFIDE; BORDETELLA PERTUSSIS; TETANUS TOXIN; THIMEROSAL 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 5; 6; 6; 8; 8; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0454_bd68b3fa-7005-4741-9c99-6fb275318754 43857-0454 HUMAN OTC DRUG Immuno Fortifier Echinacea (Angustifolia), Hydrastis Canadensis, Ligusticum Porteri, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Trigonella Foenum-Graecum, Ascorbic Acid, Pinus Sylvestris, Lymph (Suis), Medulla Ossis Suis, Spleen (Suis), Thymus (Suis), Hepar Sulphuris Calcareum, Phosphoricum Acidum, Silicea LIQUID ORAL 20170721 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; LIGUSTICUM PORTERI ROOT; MYRRH; NASTURTIUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; FENUGREEK SEED; GOLDENSEAL; ASCORBIC ACID; PINUS SYLVESTRIS LEAFY TWIG; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; CALCIUM SULFIDE; PHOSPHORIC ACID; SILICON DIOXIDE 3; 3; 3; 3; 3; 3; 5; 6; 6; 8; 8; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 43857-0455_727faf99-98d5-4e55-8fe9-8e3fa3a5c0af 43857-0455 HUMAN OTC DRUG Thyroplex Fucus Vesiculosus, Spongia Tosta, Iodium, Pulsatilla (Vulgaris), Glandula Suprarenalis Suis, Hypophysis Suis, Thyroidinum (Suis), Liothyronine Sodium, Calcarea Carbonica, Ferrum Iodatum, Kali Iodatum, Lycopus Virginicus, Phosphoricum Acidum LIQUID ORAL 20170803 UNAPPROVED HOMEOPATHIC BioActive Nutritional FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; IODINE; ANEMONE PULSATILLA; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE; LIOTHYRONINE SODIUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; POTASSIUM IODIDE; LYCOPUS VIRGINICUS; PHOSPHORIC ACID 3; 3; 6; 6; 8; 8; 8; 10; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0456_7002d03e-0f31-4fcb-bd1a-40cce34ba228 43857-0456 HUMAN OTC DRUG Inflammation I Echinacea (Angustifolia), Nasturtium Aquaticum, Phytolacca Decandra, Hydrastis Canadensis, Apis Mellifica, Belladonna, Ferrum Phosphoricum, Nitricum Acidum, Oleander, Silicea LIQUID ORAL 20170727 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; APIS MELLIFERA; ATROPA BELLADONNA WHOLE; FERROSOFERRIC PHOSPHATE; NITRIC ACID; NERIUM OLEANDER LEAF; SILICON DIOXIDE 3; 3; 3; 5; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0457_c4c611f8-2d01-4a6f-8caa-a7e891f9e236 43857-0457 HUMAN OTC DRUG Neuroforce Echinacea (Angustifolia), Hypericum Perforatum, Arnica Montana, Symphytum Officinale, Agaricus Muscarius, Arsenicum Album, Gelsemium Sempervirens, Plumbum Metallicum, Rhus tox LIQUID ORAL 20170728 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; ARNICA MONTANA; COMFREY ROOT; AMANITA MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; GELSEMIUM SEMPERVIRENS ROOT; LEAD; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0458_a7ff4e0a-b652-4386-944d-558d47ab8641 43857-0458 HUMAN OTC DRUG Gastrotone Capsicum Annuum, Foeniculum Vulgare, Symphytum Officinale, Argentum Nitricum, Arsenicum Album, Magnesia Phosphorica, Pulsatilla (Vulgaris) LIQUID ORAL 20170905 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CAPSICUM; FENNEL SEED; COMFREY ROOT; SILVER NITRATE; ARSENIC TRIOXIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS 3; 3; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0459_19c24f42-160a-4640-8890-4e1faefd1938 43857-0459 HUMAN OTC DRUG Renotox Triticum Aestivum, Asparagus Officinalis, Barosma (Betulina), Berberis Vulgaris, Echinacea (Angustifolia), Kali Muriaticum, Petroselinum Sativum, Sabal Serrulata, Solidago Virgaurea, Taraxacum Officinale, Uva-Ursi, Eupatorium Purpureum, Kidney (Suis), Bryonia (Alba), Mercurius Corrosivus, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum LIQUID ORAL 20170802 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. WHEAT; ASPARAGUS; AGATHOSMA BETULINA LEAF; BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; POTASSIUM CHLORIDE; PETROSELINUM CRISPUM; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF; EUPATORIUM PURPUREUM ROOT; PORK KIDNEY; BRYONIA ALBA ROOT; MERCURIC CHLORIDE; ALUMINUM; ANTIMONY; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LANTHANUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; HUMAN HERPESVIRUS 4; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); MEASLES VIRUS; POLIOVIRUS; BOTULINUM TOXIN TYPE A; ESCHERICHIA COLI; PROTEUS VULGARIS; PSEUDOMONAS AERUGINOSA; YERSINIA ENTEROCOLITICA; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; CLOSTRIDIUM PERFRINGENS 1; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 6; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 33; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 43857-0460_baec17ce-577d-4693-ad1e-1bb2edec7a64 43857-0460 HUMAN OTC DRUG OB Metab Fucus Vesiculosus, Capsicum Annuum, Nicotinamidum, Spongia Tosta, Croton Tiglium, Hypophysis Suis, L-Arginine, L-Ornithine, L-Tyrosine, Thyroidinum (Suis), Calcarea Carbonica, Graphites, Kali Carbonicum LIQUID ORAL 20170908 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. FUCUS VESICULOSUS; CAPSICUM; NIACINAMIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; CROTON TIGLIUM SEED; ARGININE; ORNITHINE; TYROSINE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; POTASSIUM CARBONATE 1; 3; 5; 5; 6; 6; 6; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0461_d03b21ee-61c3-4d63-a018-b8ea020ef1bb 43857-0461 HUMAN PRESCRIPTION DRUG Occuloplex G Euphrasia Officinalis, Ginkgo Biloba, Petroselinum Sativum, Vaccinium Myrtillus, Ascorbic Acid, Spigelia Anthelmia, Eye (Suis), Germanium Sesquioxide, Lithium Metallicum, Ubidecarenonum, Aurum Metallicum, Bryonia (Alba), Hepar Sulphuris Calcareum, Phosphorus, Ruta Graveolens, Sulphur LIQUID ORAL 20170906 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. EUPHRASIA STRICTA; GINKGO; PETROSELINUM CRISPUM; BILBERRY; ASCORBIC ACID; SPIGELIA ANTHELMIA; SUS SCROFA EYE; GERMANIUM SESQUIOXIDE; LITHIUM; UBIDECARENONE; GOLD; BRYONIA ALBA ROOT; CALCIUM SULFIDE; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; SULFUR 3; 3; 3; 3; 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Mood Stabilizer [EPC],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 43857-0462_64ce2878-8d3a-4e40-9acb-44079fa54bb8 43857-0462 HUMAN OTC DRUG Oligo Bio Iodine Chelidonium Majus, Spongia Tosta, Iodium, Lycopus Virginicus, Ginkgo Biloba, Pinus Sylvestris, Fucus Vesiculosus, Germanium Sesquioxide, Hypophysis Suis, Thyroidinum (Suis), Cysteinum, Manganese Gluconate, alpha-Ketoglutaricum Acidum, Calcarea Carbonica, Ferrum Iodatum, Fumaricum Acidum, Kali Iodatum, Natrum Oxalaceticum, Pulsatilla (Vulgaris), Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Eugenol, Formalinum, Lidocaine, Mercurius Solubilis, Molybdenum Metallicum, Niccolum Metallicum LIQUID ORAL 20170913 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. CHELIDONIUM MAJUS; SPONGIA OFFICINALIS SKELETON, ROASTED; IODINE; LYCOPUS VIRGINICUS; GINKGO; PINUS SYLVESTRIS LEAFY TWIG; FUCUS VESICULOSUS; GERMANIUM SESQUIOXIDE; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; CYSTEINE; MANGANESE GLUCONATE; .ALPHA.-KETOGLUTARIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; FUMARIC ACID; POTASSIUM IODIDE; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; SILVER; GOLD; COPPER; EUGENOL; FORMALDEHYDE; LIDOCAINE; MERCURIUS SOLUBILIS; MOLYBDENUM; NICKEL; PALLADIUM; TIN; TITANIUM; ZINC; MUMPS VIRUS; HUMAN COXSACKIEVIRUS A2; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B3; HUMAN COXSACKIEVIRUS B4 3; 3; 4; 6; 6; 6; 8; 8; 8; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 16; 16; 16; 16; 16 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0463_25558fd8-03f7-41b0-9314-12a13705461d 43857-0463 HUMAN OTC DRUG Venoforce I Aesculus Hippocastanum, Collinsonia Canadensis, Echinacea (Angustifolia), Hamamelis Virginiana, Pulsatilla (Vulgaris), Arnica Montana, Carbo Vegetabilis, Graphites, Hydrofluoricum Acidum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Paeonia Officinalis, Sepia LIQUID ORAL 20170921 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. HORSE CHESTNUT; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ANEMONE PULSATILLA; ARNICA MONTANA; ACTIVATED CHARCOAL; GRAPHITE; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; SEPIA OFFICINALIS JUICE 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43857-0464_8247aab5-6f21-4334-a597-71cc1e33d0c3 43857-0464 HUMAN OTC DRUG Bio Biological Detox Echinacea (Angustifolia), Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Propolis, Tabebuia Impetiginosa, Hydrastis Canadensis, Thymus Serpyllum, Glandula Suprarenalis Suis, Lymph Node (Suis), Spleen (Suis), Thyroidinum (Suis), Belladonna, Hypericum Perforatum, Phosphorus, Pyrogenium, Anthracinum, Arsenicum Album, Carbolicum Acidum, Hepar Sulphuris Calcareum, Tarentula Cubensis, Variolinum, Botulinum, Bacillus Dysentery, Gaertner Bacillus, Mutabile Bacillus, Francisella Tularensis, Coxiella Burnetii, SPRAY ORAL 20171102 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; MYRRH; NASTURTIUM OFFICINALE; PROPOLIS WAX; TABEBUIA IMPETIGINOSA BARK; GOLDENSEAL; THYMUS SERPYLLUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA SPLEEN; SUS SCROFA THYROID; ATROPA BELLADONNA; HYPERICUM PERFORATUM; PHOSPHORUS; RANCID BEEF; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARSENIC TRIOXIDE; PHENOL; CALCIUM SULFIDE; CITHARACANTHUS SPINICRUS; VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN; BOTULINUM TOXIN TYPE A; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; FRANCISELLA TULARENSIS; COXIELLA BURNETII; CANIS LUPUS FAMILIARIS MILK; PLASMODIUM MALARIAE; ESCHERICHIA COLI; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; YERSINIA PESTIS; SULFUR 3; 3; 3; 3; 3; 3; 5; 5; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 15; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 43857-0465_9914b3e1-89fa-4134-96f1-6c3364b0c53a 43857-0465 HUMAN OTC DRUG Ear Baptisia Tinctoria, Echinacea (Angustifolia), Phytolacca Decandra, Hydrastis Canadensis, Capsicum Annuum, Chamomilla, Ferrum Phosphoricum, Kali Muriaticum, Plantago Major, Pulsatilla (Vulgaris) LIQUID ORAL 20171031 UNAPPROVED HOMEOPATHIC BioActive Nutritional, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; CAPSICUM; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS 3; 3; 3; 5; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43858-110_70093531-e996-4d0c-b5d0-9b74a8af713d 43858-110 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz GmbH AMPICILLIN SODIUM 125 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43858-111_70093531-e996-4d0c-b5d0-9b74a8af713d 43858-111 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz GmbH AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43858-112_70093531-e996-4d0c-b5d0-9b74a8af713d 43858-112 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz GmbH AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43858-113_70093531-e996-4d0c-b5d0-9b74a8af713d 43858-113 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz GmbH AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43858-114_70093531-e996-4d0c-b5d0-9b74a8af713d 43858-114 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz GmbH AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43858-115_f884d20a-8e52-470d-830e-fbb278ec5b47 43858-115 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Sandoz GmbH AMPICILLIN SODIUM 10 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43858-116_29d5b646-b13e-4bc5-8575-5fa6d5c6aeeb 43858-116 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz GmbH NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43858-117_29d5b646-b13e-4bc5-8575-5fa6d5c6aeeb 43858-117 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz GmbH NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43858-118_065ebb4a-4173-4835-ae6c-43f7ddf27480 43858-118 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19840802 ANDA ANDA062527 Sandoz GmbH NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43858-123_e9974d32-be0e-4800-acc2-bb0f56a0dd4f 43858-123 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870219 ANDA ANDA062738 Sandoz GmbH AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43858-124_e9974d32-be0e-4800-acc2-bb0f56a0dd4f 43858-124 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870219 ANDA ANDA062738 Sandoz GmbH AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 43858-601_b4a56ab8-fb05-4ad2-bf73-c0543551224d 43858-601 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20151021 ANDA ANDA065063 Sandoz GmbH AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43858-602_b4a56ab8-fb05-4ad2-bf73-c0543551224d 43858-602 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20151021 ANDA ANDA065065 Sandoz GmbH AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43858-603_b4a56ab8-fb05-4ad2-bf73-c0543551224d 43858-603 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, CHEWABLE ORAL 20151021 ANDA ANDA065065 Sandoz GmbH AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43858-604_b4a56ab8-fb05-4ad2-bf73-c0543551224d 43858-604 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20151021 ANDA ANDA065066 Sandoz GmbH AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43858-605_b4a56ab8-fb05-4ad2-bf73-c0543551224d 43858-605 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20151021 ANDA ANDA065066 Sandoz GmbH AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43858-606_b4a56ab8-fb05-4ad2-bf73-c0543551224d 43858-606 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20151021 ANDA ANDA065064 Sandoz GmbH AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43858-607_b4a56ab8-fb05-4ad2-bf73-c0543551224d 43858-607 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20151021 ANDA ANDA065189 Sandoz GmbH AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 43861-1013_0da5092d-d845-442a-9cee-fceaa3813e68 43861-1013 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS INTRAGASTRIC 19770101 UNAPPROVED MEDICAL GAS Sexton Weldilng Supply Co., Inc. CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 43861-1066_46bfcc84-82f7-4c58-bb7f-2d9df93d9ad2 43861-1066 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19710101 UNAPPROVED MEDICAL GAS Sexton Weldilng Supply Co., Inc. NITROGEN 99 L/100L N 20181231 43861-1930_a46c0731-b472-4f13-b034-a2e4fd59b3fa 43861-1930 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19710101 UNAPPROVED MEDICAL GAS Sexton Weldilng Supply Co., Inc. OXYGEN 99 L/100L N 20181231 43913-402_8cf80886-2241-4e7c-af0e-50da491bf38e 43913-402 HUMAN OTC DRUG G-BUCAL-C MENTHOL, UNSPECIFIED FORM and ZINC CHLORIDE SPRAY OROPHARYNGEAL 20120101 OTC MONOGRAPH NOT FINAL part356 MCLAREN MEDICAL INC MENTHOL, UNSPECIFIED FORM; ZINC CHLORIDE 45; 30 mg/30mL; mg/30mL E 20171231 43913-403_509fb31b-09bb-4671-be8f-3dcf1771cbd3 43913-403 HUMAN OTC DRUG G-BRONCO-D GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE SUSPENSION ORAL 20120701 OTC MONOGRAPH FINAL part341 MCLAREN MEDICAL INC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 200; 10; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 43913-404_2dfe9515-b626-41d6-a129-5054814af76f 43913-404 HUMAN OTC DRUG G-Tuss-NL Dextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride LIQUID ORAL 20140211 OTC MONOGRAPH FINAL part341 McLaren Medical DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 200; 30 mg/5mL; mg/5mL; mg/5mL E 20171231 43913-405_fd524b39-a374-4991-8388-9a8554d9d844 43913-405 HUMAN OTC DRUG G-Con-X Dexbrompheniramine Maleate and Pseudoephedrine Hydrochloride LIQUID ORAL 20140211 OTC MONOGRAPH FINAL part341 McLaren Medical DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 30 mg/5mL; mg/5mL E 20171231 43913-406_bdcee84a-2613-400a-a813-8ba860ed66c0 43913-406 HUMAN OTC DRUG G-Tuss-NL Ped Dextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride LIQUID ORAL 20140211 OTC MONOGRAPH FINAL part341 McLaren Medical DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 50; 15 mg/5mL; mg/5mL; mg/5mL E 20171231 43913-407_689b0cc1-a239-4ead-95be-e59de8951f61 43913-407 HUMAN OTC DRUG G-Xpect PSE Dextromethorphan Hydrobromide, Guaifenesin, and Pseudoephedrine Hydrochloride LIQUID ORAL 20140211 OTC MONOGRAPH FINAL part341 McLaren Medical DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 200; 30 mg/5mL; mg/5mL; mg/5mL E 20171231 43935-000_33335cf4-3bcf-70c8-e054-00144ff8d46c 43935-000 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20160317 OTC MONOGRAPH NOT FINAL part333E HANGZHOU SUNKING NOWOVENS CO., LTD. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 43935-002_62e49f9d-1efd-b9b4-e053-2a91aa0a801f 43935-002 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20180116 OTC MONOGRAPH NOT FINAL part333E HANGZHOU SUNKING NOWOVENS CO., LTD. BENZALKONIUM CHLORIDE .13 g/100g N 20191231 43948-1101_fbfc1668-b5bc-44f5-af5e-3988a99802ed 43948-1101 HUMAN OTC DRUG Dr. Young 2P Pearl Brightening Balm SPF35 PA ALLANTOIN CREAM TOPICAL 20120927 OTC MONOGRAPH FINAL part347 The Doctors Cosmetics Co., Ltd ALLANTOIN .5 mg/100mL E 20171231 43948-1201_6bcf7913-61ad-4c9b-ac76-e3a49657f25f 43948-1201 HUMAN OTC DRUG AC Out Spot stOp Serum SALICYLIC ACID LIQUID TOPICAL 20120927 UNAPPROVED DRUG OTHER The Doctors Cosmetics Co., Ltd SALICYLIC ACID .1 mg/100mL E 20171231 43948-1300_ffd893d1-c9d1-478b-aed9-7c583ff0f347 43948-1300 HUMAN OTC DRUG Dr Young Protect Prevent 2P Blemish Base Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Tdc, Co. Ltd TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.67; 1.95; .27 g/30mL; g/30mL; g/30mL N 20181231 43948-1310_2983bfd0-7bb8-47b3-b754-6f0d0f7312d8 43948-1310 HUMAN OTC DRUG Dr Young Protect Prevent 2P Pearl Brightening Balm Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Tdc, Co. Ltd TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.67; 1.95; .27 g/30mL; g/30mL; g/30mL N 20181231 43948-1320_64e4b10c-ccfb-4581-b6a9-f2bdd70faa16 43948-1320 HUMAN OTC DRUG Dr Young Protect Prevent UV Cut and Ultra Light Sun Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Tdc, Co. Ltd OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 2.5; .95 g/50mL; g/50mL; g/50mL N 20181231 43948-1330_a443b0a1-b275-4fb8-bb24-16b4b5e98095 43948-1330 HUMAN OTC DRUG Dr Young Protect Prevent Triple Action BB Titanium Dioxide, Octinoxate CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Tdc, Co. Ltd TITANIUM DIOXIDE; OCTINOXATE 2.4; 2.25 g/30mL; g/30mL N 20181231 43948-1340_2d5fae1b-195b-4e84-8bd5-831ad4365a93 43948-1340 HUMAN OTC DRUG Dr Young AC CONTROL AC Out Spot stop Serum Salicylic Acid CREAM TOPICAL 20171001 UNAPPROVED DRUG OTHER Tdc, Co. Ltd SALICYLIC ACID .01 g/15mL N 20181231 43948-1350_1cd35569-2b4d-4365-a213-b5e022503e98 43948-1350 HUMAN OTC DRUG Dr Young AC CONTROL U line Clearing Mist Salicylic Acid SPRAY TOPICAL 20171001 UNAPPROVED DRUG OTHER Tdc, Co. Ltd SALICYLIC ACID .14 g/140mL N 20181231 43948-3001_617514a3-4b2a-47d3-8f9b-f3a9b1d6d3b3 43948-3001 HUMAN OTC DRUG Dr G deWrinkle BOOSTER ample by EGF ADENOSINE GLYCERIN SOLUTION/ DROPS TOPICAL 20091101 OTC MONOGRAPH FINAL part347 The Doctor's Cosmetic Inc ADENOSINE; GLYCERIN .04; .5 mL/10mL; mL/10mL E 20171231 43948-3002_35872097-4626-45cd-a1a8-2e62b0117108 43948-3002 HUMAN OTC DRUG Dr G deWrinkle FORTIFIER by EGF ADENOSINE GLYCERIN CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part347 The Doctor's Cosmetic Inc ADENOSINE; GLYCERIN .012; 2.1 mL/30mL; mL/30mL E 20171231 43948-3003_0eb7cdbf-5615-48d9-b047-9edf8611b89a 43948-3003 HUMAN OTC DRUG Dr G deWrinkle REFORMER by EGF ADENOSINE DIMETHICONE CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part347 The Doctor's Cosmetic Inc ADENOSINE; DIMETHICONE .02; .35 mL/50mL; mL/50mL E 20171231 43948-4001_cebf131b-e264-4eea-ab8a-f6ed573968d2 43948-4001 HUMAN OTC DRUG Dr G Whitening FORTIFIER by EGF ARBUTIN GLYCERIN CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part347 The Doctor's Cosmetic Inc ARBUTIN; GLYCERIN .6; 3 mL/30mL; mL/30mL E 20171231 43948-4002_d9290e62-272d-417d-880d-ab29790125d2 43948-4002 HUMAN OTC DRUG Dr G Whitening REFORMER by EGF ARBUTIN DIMETHICONE CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part347 The Doctor's Cosmetic Inc ARBUTIN; DIMETHICONE 1; 2 mL/50mL; mL/50mL E 20171231 43948-5001_7dc42f89-3624-47b8-9092-a89408e467ec 43948-5001 HUMAN OTC DRUG Dr Young 2p Blemish Base SPF35 PA ALLANTOIN CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part347 The Doctor's Cosmetic Inc ALLANTOIN 3.6 mL/60mL E 20171231 43948-5002_e037669b-3a11-4a65-8cb1-b32ca6f822f5 43948-5002 HUMAN OTC DRUG Dr Young 2p Brightening UV Sun Block SPF50 PA ARBUTIN CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part352 The Doctor's Cosmetic Inc ARBUTIN .5 mL/50mL E 20171231 43948-5003_0a5ab7a7-8dff-4daf-a586-0689e0b29f6c 43948-5003 HUMAN OTC DRUG Dr Young 2p Brightening UV Sun Block SPF50 PA ARBUTIN, ETHYLHEXYL METHOXYCINNAMATE CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part352 The Doctor's Cosmetic Inc ARBUTIN; OCTINOXATE .5; 2.5 mL/50mL; mL/50mL E 20171231 43948-6001_5ecf591f-8090-430f-8a18-eed1909b3d26 43948-6001 HUMAN OTC DRUG High Protection Sun Air Spray SPF50 PA OCTINOXATE OCTISALATE ALUMINUM HYDROXIDE SPRAY TOPICAL 20091101 OTC MONOGRAPH FINAL part352 The Doctor's Cosmetic Inc OCTINOXATE 9.75 mL/130mL E 20171231 43948-7001_5be89c26-9877-40d5-910d-16f73be10ebd 43948-7001 HUMAN OTC DRUG Hydra Intensive Blemish Balm SPF30 PA TITANIUM DIOXIDE OCTINOXATE ZINC OXIDE CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part352 The Doctor's Cosmetic Inc TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3; 1.8; .3 mL/60mL; mL/60mL; mL/60mL E 20171231 43948-8001_946e823a-ff0c-4976-9a94-0b0675f49543 43948-8001 HUMAN OTC DRUG Medi UV Block Suncream SPF50 PA OCTINOXATE OCTOCRYLENE CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part352 The Doctor's Cosmetic Inc OCTINOXATE; OCTOCRYLENE 3; .6 mL/60mL; mL/60mL E 20171231 43965-0001_80739f65-cc26-40ab-9ec1-d1691cf2620e 43965-0001 HUMAN OTC DRUG Compre Tox Eriodictyon Californicum, Hamamelis Virginiana, Nymphaea Odorata, Plantago Major, Xanthoxylum Fraxineum, Xerophyllum Asphodeloides LIQUID ORAL 20120928 UNAPPROVED HOMEOPATHIC Kevin Sullivan Navillus ERIODICTYON CALIFORNICUM LEAF; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; NYMPHAEA ODORATA ROOT; PLANTAGO MAJOR; ZANTHOXYLUM AMERICANUM BARK; XEROPHYLLUM ASPHODELOIDES; YUCCA FILAMENTOSA; GINGER 3; 3; 3; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 43975-217_788ebfde-39a2-42a4-9bd6-34ad87f66a97 43975-217 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET ORAL 20161006 ANDA ANDA075201 Amerigen Pharmaceuticals Inc. INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 43975-220_c94d8749-b1fc-4b8d-b2aa-4d063f573254 43975-220 HUMAN PRESCRIPTION DRUG Carbidopa Carbidopa TABLET ORAL 20131101 ANDA ANDA203261 Amerigen Pharmaceuticals Inc. CARBIDOPA 25 mg/1 N 20181231 43975-248_02a8038f-f4bf-4f60-9888-b1233fa947d2 43975-248 HUMAN PRESCRIPTION DRUG Nebivolol Nebivolol TABLET ORAL 20150428 ANDA ANDA203659 Amerigen Pharmaceuticals Inc. NEBIVOLOL HYDROCHLORIDE 2.5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43975-249_02a8038f-f4bf-4f60-9888-b1233fa947d2 43975-249 HUMAN PRESCRIPTION DRUG Nebivolol Nebivolol TABLET ORAL 20150428 ANDA ANDA203659 Amerigen Pharmaceuticals Inc. NEBIVOLOL HYDROCHLORIDE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43975-250_02a8038f-f4bf-4f60-9888-b1233fa947d2 43975-250 HUMAN PRESCRIPTION DRUG Nebivolol Nebivolol TABLET ORAL 20150428 ANDA ANDA203659 Amerigen Pharmaceuticals Inc. NEBIVOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43975-251_02a8038f-f4bf-4f60-9888-b1233fa947d2 43975-251 HUMAN PRESCRIPTION DRUG Nebivolol Nebivolol TABLET ORAL 20150428 ANDA ANDA203659 Amerigen Pharmaceuticals Inc. NEBIVOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 43975-252_2f7a0015-4a92-4224-8105-599481e4fa44 43975-252 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE ORAL 20160713 ANDA ANDA203490 Amerigen Pharmaceuticals Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 43975-253_2f7a0015-4a92-4224-8105-599481e4fa44 43975-253 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE ORAL 20160713 ANDA ANDA203490 Amerigen Pharmaceuticals Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 43975-254_2f7a0015-4a92-4224-8105-599481e4fa44 43975-254 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE ORAL 20160713 ANDA ANDA203490 Amerigen Pharmaceuticals Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 43975-255_2f7a0015-4a92-4224-8105-599481e4fa44 43975-255 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE ORAL 20160713 ANDA ANDA203490 Amerigen Pharmaceuticals Inc. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 43975-256_2f7a0015-4a92-4224-8105-599481e4fa44 43975-256 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE ORAL 20160713 ANDA ANDA203490 Amerigen Pharmaceuticals Inc. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 43975-257_2f7a0015-4a92-4224-8105-599481e4fa44 43975-257 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE TEMOZOLOMIDE CAPSULE ORAL 20160713 ANDA ANDA203490 Amerigen Pharmaceuticals Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 43975-304_788ebfde-39a2-42a4-9bd6-34ad87f66a97 43975-304 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET ORAL 20161006 ANDA ANDA075201 Amerigen Pharmaceuticals Inc. INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 43979-400_48d9793a-aed9-47b0-a246-e767b201bc7f 43979-400 HUMAN OTC DRUG Golf Pain Away GPA Tea Tree OIl and Eucalyptus Oil OIL TOPICAL 20120601 UNAPPROVED DRUG OTHER Elmore Oil Company Pty Ltd TEA TREE OIL; EUCALYPTUS OIL 42.5; 38.6 mg/mL; mg/mL E 20171231 43979-439_20ccb5e0-2227-408e-b1ad-6e62ba1dc3de 43979-439 HUMAN OTC DRUG Elmore Oil Tea Tree OIl and Eucalyptus Oil OIL TOPICAL 20130701 UNAPPROVED DRUG OTHER Elmore Oil Company Pty Ltd TEA TREE OIL; EUCALYPTUS OIL 42.5; 38.6 mg/mL; mg/mL E 20171231 43979-445_3b04cd1f-ed03-47df-9315-1a085ec373c1 43979-445 HUMAN OTC DRUG Outback 2-in-1 Insect Repellent and Protective Sunscreen Octinoxate,4-Methylbenzylidene Camphor and Zinc CREAM TOPICAL 20120701 UNAPPROVED DRUG OTHER Elmore Oil Company Pty Ltd OCTINOXATE; ENZACAMENE; ZINC OXIDE 90; 13; 80 mg/mL; mg/mL; mg/mL E 20171231 43979-446_28745142-046e-4552-bd9b-1653fbb1a647 43979-446 HUMAN OTC DRUG Outback Series 2-in-1 Sunscreen Octyl Methoxycinnamate,Avobenzone and Zinc Oxide CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Elmore Oil Company Pty Ltd OCTINOXATE; AVOBENZONE; ZINC OXIDE 75; 13; 80 mg/mL; mg/mL; mg/mL E 20171231 43979-550_5109c9ab-837e-4705-ac81-83a552023a11 43979-550 HUMAN OTC DRUG Out Back Pain Relief Tea Tree OIl and Eucalyptus Oil OIL TOPICAL 20121001 UNAPPROVED DRUG OTHER Elmore Oil Company Pty Ltd TEA TREE OIL; EUCALYPTUS OIL 42.5; 38.6 mg/mL; mg/mL E 20171231 44001-321_f5157025-9ab5-4697-81bc-1adb13ea1dfc 44001-321 HUMAN PRESCRIPTION DRUG FACTIVE gemifloxacin mesylate TABLET ORAL 20030404 NDA NDA021158 Merus Labs International Inc. GEMIFLOXACIN MESYLATE 320 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 44004-321_178042cd-894a-4368-a36b-1484bb1c012d 44004-321 HUMAN PRESCRIPTION DRUG FACTIVE gemifloxacin mesylate TABLET ORAL 20030404 NDA NDA021158 Vansen Pharma Inc. GEMIFLOXACIN MESYLATE 320 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 44004-801_f99cc35f-6ffa-4f2e-bcdf-e51bb9a17c0d 44004-801 HUMAN PRESCRIPTION DRUG Spectracef cefditoren pivoxil TABLET, FILM COATED ORAL 20130205 NDA NDA021222 Vansen Pharma Inc. CEFDITOREN PIVOXIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 44004-802_f99cc35f-6ffa-4f2e-bcdf-e51bb9a17c0d 44004-802 HUMAN PRESCRIPTION DRUG Spectracef Cefditoren Pivoxil TABLET, FILM COATED ORAL 20130205 NDA NDA021222 Vansen Pharma Inc. CEFDITOREN PIVOXIL 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 44009-801_edeaf75d-92f5-4fef-a127-ad200561aa71 44009-801 HUMAN PRESCRIPTION DRUG Cefditoren Pivoxil cefditoren pivoxil TABLET, FILM COATED ORAL 20130212 NDA NDA021222 Pharma RomLev Inc. CEFDITOREN PIVOXIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 44009-802_edeaf75d-92f5-4fef-a127-ad200561aa71 44009-802 HUMAN PRESCRIPTION DRUG Cefditoren Pivoxil cefditoren pivoxil TABLET, FILM COATED ORAL 20100101 NDA NDA021222 Pharma RomLev Inc. CEFDITOREN PIVOXIL 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 44014-085_3656d7ee-bd4c-422c-8e4b-f24517dddc57 44014-085 HUMAN OTC DRUG Icy Hot Medicated Roll, Medium Menthol PATCH TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part348 Nichiban Company Limited MENTHOL 787.5 mg/1 E 20171231 44014-086_3656d7ee-bd4c-422c-8e4b-f24517dddc57 44014-086 HUMAN OTC DRUG Icy Hot Medicated Roll, Large Menthol PATCH TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part348 Nichiban Company Limited MENTHOL 866.25 mg/1 E 20171231 44019-000_615914d2-bd31-4048-e053-2991aa0a41d8 44019-000 HUMAN OTC DRUG Antibacterial Moisturizing Hand Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part333E Yinjing Medical Technology (Shanghai) Co., Ltd. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 44019-001_61592bda-a643-4052-e053-2991aa0a74f8 44019-001 HUMAN OTC DRUG MEDICATED-PADS Hemorrhoidal Pads with Witch Hazel WITCH HAZEL LIQUID TOPICAL 20160803 OTC MONOGRAPH FINAL part346 Yinjing Medical Technology (Shanghai) Co., Ltd. WITCH HAZEL 50 g/100g N 20181231 44019-002_615931fe-8862-a1f2-e053-2991aa0a6772 44019-002 HUMAN OTC DRUG Flushable Medicated Wipes Hemorrhoidal Pads with Witch Hazel and Aloe WITCH HAZEL LIQUID TOPICAL 20130708 OTC MONOGRAPH FINAL part346 Yinjing Medical Technology (Shanghai) Co., Ltd. WITCH HAZEL 50 g/100g N 20181231 44019-003_61592bda-a651-4052-e053-2991aa0a74f8 44019-003 HUMAN OTC DRUG Antimicrobial Alcohol Hand wipes ALCOHOL LIQUID TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333E Yinjing Medical Technology (Shanghai) Co., Ltd. ALCOHOL 65.9 g/100g N 20181231 44019-004_61592e61-0d21-2a1f-e053-2a91aa0a8036 44019-004 HUMAN OTC DRUG Skin Protectant Flushable Wipes DIMETHICONE LIQUID TOPICAL 20160803 OTC MONOGRAPH FINAL part347 Yinjing Medical Technology (Shanghai) Co., Ltd. DIMETHICONE 3.2 g/100g N 20181231 44019-005_85244a4b-c688-43f2-b3a4-f659943827a1 44019-005 HUMAN OTC DRUG moist wipes BENZALKONIUM CHLORIDE LOTION TOPICAL 20160615 OTC MONOGRAPH NOT FINAL part333A Yinjing Medical Technology (Shanghai) Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 44019-006_6fb89ccc-8f39-4563-804d-2e2e704423b0 44019-006 HUMAN OTC DRUG Acne Wipes SALICYLIC ACID SWAB TOPICAL 20160720 OTC MONOGRAPH FINAL part333D Yinjing Medical Technology (Shanghai) Co., Ltd. SALICYLIC ACID .5 g/100mL N 20181231 44019-007_6e54e1d3-41c0-4865-a207-129a9d430542 44019-007 HUMAN OTC DRUG moist wipes BENZALKONIUM CHLORIDE LOTION TOPICAL 20160726 OTC MONOGRAPH NOT FINAL part333A Yinjing Medical Technology (Shanghai) Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 44019-008_68b6a488-4d19-40c1-ba23-186153561a3d 44019-008 HUMAN OTC DRUG Assured Isopropyl Alcohol PATCH TOPICAL 20130104 OTC MONOGRAPH NOT FINAL part333A Yinjing Medical Technology (Shanghai) Co., Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 44019-100_616db8a9-6108-ed9a-e053-2a91aa0a32c7 44019-100 HUMAN OTC DRUG POVIDONE-IODINE PREP POVIDONE-IODINE PATCH TOPICAL 20170707 OTC MONOGRAPH NOT FINAL part333A Yinjing Medical Technology (Shanghai) Co., Ltd. POVIDONE-IODINE 10 g/100g N 20181231 44019-111_3ad274a5-a9ab-30c3-e054-00144ff88e88 44019-111 HUMAN OTC DRUG ALCOHOL PREP PAD - MEDIUM ISOPROPYL ALCOHOL SWAB TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333A Yinjing Medical Technology (Shanghai) Co., Ltd. ISOPROPYL ALCOHOL 70 g/100g N 20181231 44019-112_3ad21434-35d6-21e5-e054-00144ff88e88 44019-112 HUMAN OTC DRUG ALCOHOL PREP PAD - LARGE ISOPROPYL ALCOHOL SWAB TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333A Yinjing Medical Technology (Shanghai) Co., Ltd. ISOPROPYL ALCOHOL 70 g/100g N 20181231 44019-211_615940bc-14e9-3e74-e053-2a91aa0a22ae 44019-211 HUMAN OTC DRUG POVIDONE-IODINE PREP PAD POVIDONE-IODINE SWAB TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333A Yinjing Medical Technology (Shanghai) Co., Ltd. POVIDONE-IODINE 10 g/100g N 20181231 44019-236_61964a72-6962-a6dc-e053-2991aa0a8349 44019-236 HUMAN OTC DRUG POVIDONE IODINE povidone-iodine SWAB TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333A Yinjing Medical Technology (Shanghai) Co., Ltd. POVIDONE-IODINE 10 g/100g N 20181231 44019-323_6159370e-3de2-ac48-e053-2991aa0aaea1 44019-323 HUMAN OTC DRUG BZK ANTISEPTIC TOWELETTE BENZALKONIUM CHLORIDE SWAB TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333A Yinjing Medical Technology (Shanghai) Co., Ltd. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 44019-400_615940bc-14f8-3e74-e053-2a91aa0a22ae 44019-400 HUMAN OTC DRUG Baby Wipes with Allantoin ALLANTOIN LIQUID TOPICAL 20160803 OTC MONOGRAPH FINAL part347 Yinjing Medical Technology (Shanghai) Co., Ltd. ALLANTOIN .5 g/100g N 20181231 44019-401_61594cdf-df46-479c-e053-2a91aa0a5d26 44019-401 HUMAN OTC DRUG Healthcare Antiseptic Towelette CHLOROXYLENOL LIQUID TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333E Yinjing Medical Technology (Shanghai) Co., Ltd. CHLOROXYLENOL .5 g/100g N 20181231 44019-911_543515c9-9c76-1948-e054-00144ff88e88 44019-911 HUMAN OTC DRUG STING RELIEF PAD Benzocaine, Isopropyl Alcohol PATCH TOPICAL 20160823 OTC MONOGRAPH NOT FINAL part348 Yinjing Medical Technology (Shanghai) Co., Ltd. BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 g/mL; mL/mL N 20181231 44076-006_910f8bc6-0ec8-41db-bca6-926885e7d62b 44076-006 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20070401 NDA NDA205839 American Welding & Gas NITROGEN 990 mL/L N 20181231 44076-010_2d877f4c-b844-420d-aad7-581a12d24444 44076-010 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870401 NDA NDA205840 American Welding & Gas, Inc. OXYGEN 990 mL/L N 20181231 44076-012_60b2e28d-8344-60dd-e053-2a91aa0a3c5a 44076-012 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20140501 NDA NDA205704 American Welding & Gas NITROUS OXIDE 990 mL/L N 20181231 44087-0004_9b26f993-2f9d-4e0e-94e0-b72e19b0b86d 44087-0004 HUMAN PRESCRIPTION DRUG Serostim somatropin KIT SUBCUTANEOUS 19970725 NDA NDA020604 EMD Serono, Inc. N 20181231 44087-0005_9b26f993-2f9d-4e0e-94e0-b72e19b0b86d 44087-0005 HUMAN PRESCRIPTION DRUG Serostim somatropin KIT SUBCUTANEOUS 19960823 NDA NDA020604 EMD Serono, Inc. N 20181231 44087-0006_9b26f993-2f9d-4e0e-94e0-b72e19b0b86d 44087-0006 HUMAN PRESCRIPTION DRUG Serostim somatropin KIT SUBCUTANEOUS 19960823 NDA NDA020604 EMD Serono, Inc. N 20181231 44087-0016_796d492b-6871-4968-8c23-beeeb788d172 44087-0016 HUMAN PRESCRIPTION DRUG saizenprep somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 20170117 NDA NDA019764 EMD Serono, Inc. N 20181231 44087-0022_a0782365-7987-4882-94f7-20bd85e40401 44087-0022 HUMAN PRESCRIPTION DRUG REBIF INTERFERON BETA-1A INJECTION, SOLUTION SUBCUTANEOUS 20020307 BLA BLA103780 EMD Serono, Inc. INTERFERON BETA-1A 22 ug/.5mL Interferon-beta [Chemical/Ingredient],Recombinant Human Interferon beta [EPC],Recombinant Proteins [Chemical/Ingredient] N 20181231 44087-0044_a0782365-7987-4882-94f7-20bd85e40401 44087-0044 HUMAN PRESCRIPTION DRUG REBIF interferon beta-1a INJECTION, SOLUTION SUBCUTANEOUS 20020307 BLA BLA103780 EMD Serono, Inc. INTERFERON BETA-1A 44 ug/.5mL Interferon-beta [Chemical/Ingredient],Recombinant Human Interferon beta [EPC],Recombinant Proteins [Chemical/Ingredient] N 20181231 44087-0188_a0782365-7987-4882-94f7-20bd85e40401 44087-0188 HUMAN PRESCRIPTION DRUG REBIF REBIDOSE INTERFERON BETA-1A KIT SUBCUTANEOUS 20121221 BLA BLA103780 EMD Serono, Inc. N 20181231 44087-1005_796d492b-6871-4968-8c23-beeeb788d172 44087-1005 HUMAN PRESCRIPTION DRUG Saizen somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 19961008 NDA NDA019764 EMD Serono, Inc. N 20181231 44087-1080_796d492b-6871-4968-8c23-beeeb788d172 44087-1080 HUMAN PRESCRIPTION DRUG SAIZEN CLICKEASY somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 20040709 NDA NDA019764 EMD Serono, Inc. N 20181231 44087-1088_796d492b-6871-4968-8c23-beeeb788d172 44087-1088 HUMAN PRESCRIPTION DRUG Saizen somatropin KIT INTRAMUSCULAR; SUBCUTANEOUS 20000829 NDA NDA019764 EMD Serono, Inc. N 20181231 44087-1112_e93e7b13-ccd8-4d8a-896d-4581820283b5 44087-1112 HUMAN PRESCRIPTION DRUG Gonal-f RFF Pen folltropin alfa INJECTION, SOLUTION SUBCUTANEOUS 20040525 NDA NDA021684 EMD Serono, Inc. FOLLITROPIN 450 [iU]/.75mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] E 20171231 44087-1113_e93e7b13-ccd8-4d8a-896d-4581820283b5 44087-1113 HUMAN PRESCRIPTION DRUG Gonal-f RFF Pen folltropin alfa INJECTION, SOLUTION SUBCUTANEOUS 20040525 NDA NDA021684 EMD Serono, Inc. FOLLITROPIN 300 [iU]/.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] E 20171231 44087-1114_e93e7b13-ccd8-4d8a-896d-4581820283b5 44087-1114 HUMAN PRESCRIPTION DRUG Gonal-f RFF Pen folltropin alfa INJECTION, SOLUTION SUBCUTANEOUS 20040525 NDA NDA021684 EMD Serono, Inc. FOLLITROPIN 900 [iU]/1.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] E 20171231 44087-1115_4bf9f6a0-c586-4475-b953-4d92bcf558b1 44087-1115 HUMAN PRESCRIPTION DRUG Gonal-f RFF Redi-ject FOLLITROPIN INJECTION, SOLUTION SUBCUTANEOUS 20131016 NDA NDA021684 EMD Serono, Inc. FOLLITROPIN 300 [iU]/.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] N 20181231 44087-1116_4bf9f6a0-c586-4475-b953-4d92bcf558b1 44087-1116 HUMAN PRESCRIPTION DRUG Gonal-f RFF Redi-ject FOLLITROPIN INJECTION, SOLUTION SUBCUTANEOUS 20131016 NDA NDA021684 EMD Serono, Inc. FOLLITROPIN 450 [iU]/.75mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] N 20181231 44087-1117_4bf9f6a0-c586-4475-b953-4d92bcf558b1 44087-1117 HUMAN PRESCRIPTION DRUG Gonal-f RFF Redi-ject FOLLITROPIN INJECTION, SOLUTION SUBCUTANEOUS 20131016 NDA NDA021684 EMD Serono, Inc. FOLLITROPIN 900 [iU]/1.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] N 20181231 44087-1150_aa66e33f-3db4-4658-b31f-aef336eca26d 44087-1150 HUMAN PRESCRIPTION DRUG Ovidrel choriogonadotropin alfa INJECTION, SOLUTION SUBCUTANEOUS 20031006 NDA NDA021149 EMD Serono, Inc. CHORIOGONADOTROPIN ALFA 250 ug/.5mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient] N 20181231 44087-1225_7d99cb32-36dd-4d14-9b79-451266168ecb 44087-1225 HUMAN PRESCRIPTION DRUG Cetrotide cetrorelix acetate KIT SUBCUTANEOUS 20000811 NDA NDA021197 EMD Serono, Inc. N 20181231 44087-2011_9952905b-10a4-45d6-8eec-c4104aca002f 44087-2011 HUMAN PRESCRIPTION DRUG Egrifta tesamorelin KIT SUBCUTANEOUS 20120905 NDA NDA022505 EMD Serono, Inc. E 20171231 44087-3322_a0782365-7987-4882-94f7-20bd85e40401 44087-3322 HUMAN PRESCRIPTION DRUG REBIF REBIDOSE INTERFERON BETA-1A INJECTION, SOLUTION SUBCUTANEOUS 20121221 BLA BLA103780 EMD Serono, Inc. INTERFERON BETA-1A 22 ug/.5mL Interferon-beta [Chemical/Ingredient],Recombinant Human Interferon beta [EPC],Recombinant Proteins [Chemical/Ingredient] N 20181231 44087-3344_a0782365-7987-4882-94f7-20bd85e40401 44087-3344 HUMAN PRESCRIPTION DRUG REBIF REBIDOSE INTERFERON BETA-1A INJECTION, SOLUTION SUBCUTANEOUS 20121221 BLA BLA103780 EMD Serono, Inc. INTERFERON BETA-1A 44 ug/.5mL Interferon-beta [Chemical/Ingredient],Recombinant Human Interferon beta [EPC],Recombinant Proteins [Chemical/Ingredient] N 20181231 44087-3388_d2eda5ae-85e0-4155-97ea-a8a63a846f37 44087-3388 HUMAN PRESCRIPTION DRUG Zorbtive somatropin KIT SUBCUTANEOUS 20031201 NDA NDA021597 EMD Serono, Inc. N 20181231 44087-3535_8ee01856-b2ca-4b44-baaa-84a62573264b 44087-3535 HUMAN PRESCRIPTION DRUG BAVENCIO avelumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170323 BLA BLA761049 EMD Serono, Inc. AVELUMAB 20 mg/mL Programmed Death Ligand-1 Blocker [EPC],Programmed Death Ligand-1 Antagonists [MoA],Programmed Death Ligand-1-directed Antibody Interactions [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 44087-8822_a0782365-7987-4882-94f7-20bd85e40401 44087-8822 HUMAN PRESCRIPTION DRUG Rebif interferon beta-1a KIT SUBCUTANEOUS 20041217 BLA BLA103780 EMD Serono, Inc. N 20181231 44087-9005_eee6873e-7110-405e-bbc2-e4646a0df9a3 44087-9005 HUMAN PRESCRIPTION DRUG GONAL-F RFF follitropin alfa KIT SUBCUTANEOUS 20040325 NDA NDA021765 EMD Serono, Inc. N 20181231 44087-9030_af433a42-2178-473c-815a-d900942505d6 44087-9030 HUMAN PRESCRIPTION DRUG Gonal-f follitropin alfa KIT SUBCUTANEOUS 20040325 NDA NDA020378 EMD Serono, Inc. N 20181231 44087-9070_af433a42-2178-473c-815a-d900942505d6 44087-9070 HUMAN PRESCRIPTION DRUG Gonal-f follitropin alfa KIT SUBCUTANEOUS 20040325 NDA NDA020378 EMD Serono, Inc. N 20181231 44099-001_e1e3e28b-494d-440d-a456-385f8acd32aa 44099-001 HUMAN OTC DRUG skin MD Natural octinoxate, octisalate, homosalate LOTION TOPICAL 20080819 OTC MONOGRAPH NOT FINAL part352 21st Century Formulations OCTINOXATE; OCTISALATE; HOMOSALATE 7; 5; 3 mg/100mL; mg/100mL; mg/100mL N 20181231 44114-001_424f1042-47fb-4dc5-adc4-39c8985d4ec7 44114-001 HUMAN OTC DRUG Antibacterial Hand Sanitizer ALCOHOL SOLUTION TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part333E Scents Alive ALCOHOL .62 mL/mL E 20171231 44117-0001_f7c97c4f-7542-445a-96b4-5d2d8617b5c0 44117-0001 HUMAN OTC DRUG Testosterone Testosterone TABLET ORAL 20130403 UNAPPROVED HOMEOPATHIC Zoe Processing TESTOSTERONE 30 [hp_X]/mg N 20181231 44117-0002_e121aea2-a01c-465b-b048-8df536fa7953 44117-0002 HUMAN OTC DRUG Testosterone Testosterone, TABLET ORAL 20140429 UNAPPROVED HOMEOPATHIC Zoe Processing TESTOSTERONE 30 [hp_X]/1 N 20181231 44118-750_60c8daea-0a2d-a274-e053-2a91aa0aba42 44118-750 HUMAN PRESCRIPTION DRUG Duet DHA Balanced .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, MAGNESIUM, ZINC OXIDE, SODIUM SELENATE, CUPRIC OXIDE, IODINE, CHOLINE, OMEGA-3 FATTY ACIDS KIT 20121030 UNAPPROVED DRUG OTHER Eckson Labs, LLC N 20181231 44118-807_60ccbdf2-942e-3f1e-e053-2a91aa0ac993 44118-807 HUMAN PRESCRIPTION DRUG Duet DHA 400 .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IODINE, OMEGA-3 FATTY ACIDS KIT ORAL 20110909 UNAPPROVED DRUG OTHER Eckson Labs, LLC N 20181231 44118-902_60c77a68-4415-92e5-e053-2991aa0a3c84 44118-902 HUMAN PRESCRIPTION DRUG NataChew .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, IRON, NIACINAMIDE TABLET, CHEWABLE ORAL 20121015 UNAPPROVED DRUG OTHER Eckson Labs, LLC .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; IRON; NIACINAMIDE 2700; 120; 400; 20; 2; 3; 10; 1; 12; 28; 20 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 44183-880_5d167b20-6068-113b-e053-2a91aa0a9abf 44183-880 HUMAN PRESCRIPTION DRUG Desvenlafaxine Extended-release desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130710 NDA AUTHORIZED GENERIC NDA204683 Macoven Pharmaceuticals DESVENLAFAXINE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 44183-890_5d167b20-6068-113b-e053-2a91aa0a9abf 44183-890 HUMAN PRESCRIPTION DRUG Desvenlafaxine Extended-release desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130710 NDA AUTHORIZED GENERIC NDA204683 Macoven Pharmaceuticals DESVENLAFAXINE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 44206-251_618042b1-e7eb-4ff7-a547-c96aaa7076bd 44206-251 PLASMA DERIVATIVE AlbuRx ALBUMIN (HUMAN) SOLUTION INTRAVENOUS 20090106 BLA BLA102366 CSL Behring AG ALBUMIN HUMAN 12.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 44206-300_81aef654-4f74-4547-a259-d558b6869c54 44206-300 PLASMA DERIVATIVE Rhophylac HUMAN RHO(D) IMMUNE GLOBULIN SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090106 BLA BLA125070 CSL Behring AG HUMAN RHO(D) IMMUNE GLOBULIN 1500 [iU]/2mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Endogenous Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 44206-310_a76d7317-b85a-4050-a21f-bdad34da5113 44206-310 PLASMA DERIVATIVE AlbuRx ALBUMIN (HUMAN) SOLUTION INTRAVENOUS 20090106 BLA BLA102366 CSL Behring AG ALBUMIN HUMAN 12.5 g/250mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 44206-417_a42c1c72-8631-4dba-8bba-2e6a2a701da3 44206-417 PLASMA DERIVATIVE Carimune Nanofiltered HUMAN IMMUNOGLOBULIN G INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090210 BLA BLA102367 CSL Behring AG HUMAN IMMUNOGLOBULIN G 6 g/1 Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 44206-418_a42c1c72-8631-4dba-8bba-2e6a2a701da3 44206-418 PLASMA DERIVATIVE Carimune Nanofiltered HUMAN IMMUNOGLOBULIN G INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090210 BLA BLA102367 CSL Behring AG HUMAN IMMUNOGLOBULIN G 12 g/1 Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 44206-436_e61a518f-4c78-41e6-86ed-2486561b2cf4 44206-436 PLASMA DERIVATIVE Privigen Human Immunoglobulin G LIQUID INTRAVENOUS 20090120 BLA BLA125201 CSL Behring AG HUMAN IMMUNOGLOBULIN G 5 g/50mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 44206-437_e61a518f-4c78-41e6-86ed-2486561b2cf4 44206-437 PLASMA DERIVATIVE Privigen Human Immunoglobulin G LIQUID INTRAVENOUS 20090120 BLA BLA125201 CSL Behring AG HUMAN IMMUNOGLOBULIN G 10 g/100mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 44206-438_e61a518f-4c78-41e6-86ed-2486561b2cf4 44206-438 PLASMA DERIVATIVE Privigen Human Immunoglobulin G LIQUID INTRAVENOUS 20090120 BLA BLA125201 CSL Behring AG HUMAN IMMUNOGLOBULIN G 20 g/200mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 44206-439_e61a518f-4c78-41e6-86ed-2486561b2cf4 44206-439 PLASMA DERIVATIVE Privigen Human Immunoglobulin G LIQUID INTRAVENOUS 20090120 BLA BLA125201 CSL Behring AG HUMAN IMMUNOGLOBULIN G 40 g/400mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 44206-451_414ab6b7-15a9-4b09-9715-82cef5cb78cf 44206-451 PLASMA DERIVATIVE Hizentra HUMAN IMMUNOGLOBULIN G LIQUID SUBCUTANEOUS 20111003 BLA BLA125350 CSL Behring AG HUMAN IMMUNOGLOBULIN G .2 g/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 44206-452_414ab6b7-15a9-4b09-9715-82cef5cb78cf 44206-452 PLASMA DERIVATIVE Hizentra HUMAN IMMUNOGLOBULIN G LIQUID SUBCUTANEOUS 20111003 BLA BLA125350 CSL Behring AG HUMAN IMMUNOGLOBULIN G .2 g/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 44206-454_414ab6b7-15a9-4b09-9715-82cef5cb78cf 44206-454 PLASMA DERIVATIVE Hizentra HUMAN IMMUNOGLOBULIN G LIQUID SUBCUTANEOUS 20111003 BLA BLA125350 CSL Behring AG HUMAN IMMUNOGLOBULIN G .2 g/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 44206-455_414ab6b7-15a9-4b09-9715-82cef5cb78cf 44206-455 PLASMA DERIVATIVE Hizentra HUMAN IMMUNOGLOBULIN G LIQUID SUBCUTANEOUS 20111003 BLA BLA125350 CSL Behring AG HUMAN IMMUNOGLOBULIN G .2 g/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 44206-532_956999c6-95ee-4889-b149-4ab73f43f931 44206-532 PLASMA DERIVATIVE Cytogam Human Cytomegalovirus Immune Globulin LIQUID INTRAVENOUS 20090106 BLA BLA103189 CSL Behring AG HUMAN CYTOMEGALOVIRUS IMMUNE GLOBULIN 50 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] N 20181231 44224-0102_4adc9c0d-9ef3-281b-e054-00144ff8d46c 44224-0102 HUMAN OTC DRUG Adventure Medical Kits Dental Medic Benzocaine KIT ORAL; TOPICAL 20120919 OTC MONOGRAPH NOT FINAL part333A Tender Corporation N 20181231 44224-0118_57553fbf-e04c-4bb3-8a1e-3cdb7fd52f52 44224-0118 HUMAN OTC DRUG Mountain Series Weekender Medical BENZALKONIUM CHLORIDE, POVIDONE-IODINE, ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20110801 OTC MONOGRAPH FINAL part333A Tender Corporation dba Adventure Medical Kits E 20171231 44224-0120_4aca084a-fc33-360e-e054-00144ff88e88 44224-0120 HUMAN OTC DRUG Adventure First Aid Water Resistant Benzocaine, alcohol KIT ORAL; TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Tender Corporation N 20181231 44224-0203_4ad9d0a5-cd18-0808-e054-00144ff8d46c 44224-0203 HUMAN OTC DRUG Adventure First Aid .5 Tin BENZOCAINE, ALCOHOL, BENZALKONIUM CHLORIDE KIT ORAL; TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Tender Corporation N 20181231 44224-0299_63969fb7-907b-4788-8e6d-9c9c21e2c18f 44224-0299 HUMAN OTC DRUG Easy Care First Aid BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B KIT 20110407 OTC MONOGRAPH FINAL part348 Tender Corp dba Adventure Medical Kits E 20171231 44224-0468_4adc5dc0-4387-478c-e054-00144ff88e88 44224-0468 HUMAN OTC DRUG Suture Syringe Medic benzalkonium chloride, alcohol KIT TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Tender Corporation N 20181231 44224-0699_c7ffd563-e629-424b-af33-1730ea9bafc5 44224-0699 HUMAN OTC DRUG Easy Care First Aid Kit - Outdoor and Travel BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, IBUPROFEN, ACETAMINOPHEN KIT 20110413 OTC MONOGRAPH FINAL part348 Tender Corp dba Adventure Medical Kits E 20171231 44224-0999_434e6dde-b242-4b12-b9ee-a8477063bf60 44224-0999 HUMAN OTC DRUG Easy Care First Aid Kit - Sports and Travel BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, IBUPROFEN, ACETAMINOPHEN KIT 20110413 OTC MONOGRAPH FINAL part348 Tender Corp dba Adventure Medical Kits E 20171231 44224-1000_42d68a3b-5d81-41cc-8de8-f14402850ff7 44224-1000 HUMAN OTC DRUG ADVENTURE MEDICAL KITS 1 PERSON FIRST AID BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL KIT 20100825 OTC MONOGRAPH FINAL part348 Tender Corp dba Adventure Medical Kits N 20181231 44224-1030_3fdd097b-87b8-46d2-e054-00144ff88e88 44224-1030 HUMAN OTC DRUG After Bite the Itch Eraser SODIUM BICARBONATE LIQUID TOPICAL 20140902 OTC MONOGRAPH FINAL part347 Tender Corporation SODIUM BICARBONATE 50 mg/mL N 20181231 44224-1270_404015f1-e11d-4632-e054-00144ff8d46c 44224-1270 HUMAN OTC DRUG After Bite Xtra Diphenhydramine HCl GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part348 Tender Corporation DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/mL N 20181231 44224-1280_3fdb399c-9213-0827-e054-00144ff88e88 44224-1280 HUMAN OTC DRUG After Bite Kids SODIUM BICARBONATE LIQUID TOPICAL 20141126 OTC MONOGRAPH FINAL part347 Tender Corporation SODIUM BICARBONATE 5 g/100g N 20181231 44224-1499_58b9bec3-55b9-4d73-b4aa-97ca425d9f52 44224-1499 HUMAN OTC DRUG Easy Care First Aid Chest - Home and Workshop BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B KIT 20110413 OTC MONOGRAPH FINAL part348 Tender Corp dba Adventure Medical Kits E 20171231 44224-1560_403f6343-f921-1adb-e054-00144ff8d46c 44224-1560 HUMAN OTC DRUG After Bite Outdoor Diphenhydramine HCl GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part348 Tender Corporation DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/mL N 20181231 44224-1750_4ac65895-0a6d-1d93-e054-00144ff88e88 44224-1750 HUMAN OTC DRUG After Bite Sensitive SODIUM BICARBONATE LIQUID TOPICAL 20141126 OTC MONOGRAPH FINAL part347 Tender Corporation SODIUM BICARBONATE 5 g/100g N 20181231 44224-1760_3fdd411d-8d29-4d36-e054-00144ff88e88 44224-1760 HUMAN OTC DRUG After Bite Plus DIPHENHYDRAMINE HYDROCHLORIDE CREAM TOPICAL 20120703 OTC MONOGRAPH NOT FINAL part348 Tender Corporation DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/mL N 20181231 44224-1840_4ac5bd99-0a8c-6793-e054-00144ff8d46c 44224-1840 HUMAN OTC DRUG After Sting Diphenhydramine HCl GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part348 Tender Corporation DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/mL N 20181231 44224-1999_2f632b22-3649-433d-b2fa-748e01085413 44224-1999 HUMAN OTC DRUG Easy Care First Aid - All Purpose BENZALKONIUM CHLORIDE, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, IBUPROFEN, ACETAMINOPHEN KIT 20110415 OTC MONOGRAPH FINAL part348 Tender Corp dba Adventure Medical Kits E 20171231 44224-2000_22f141f4-f307-4e18-a8ca-275e075f2547 44224-2000 HUMAN OTC DRUG ADVENTURE MEDICAL KITS 1-2 PERSON FIRST AID BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN, DIPHENHYDRAMINE CHLORIDE KIT TOPICAL 20100826 OTC MONOGRAPH NOT FINAL part333B Tender Corp dba Adventure Medical Kits N 20181231 44224-2400_24fbc220-ff82-1a27-e054-00144ff8d46c 44224-2400 HUMAN OTC DRUG The Itch Eraser Max Strength DIPHENHYDRAMINE HYDROCHLORIDE GEL TOPICAL 20151117 OTC MONOGRAPH NOT FINAL part348 Tender Corporation DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/g N 20181231 44224-2410_26190269-bf92-591a-e054-00144ff8d46c 44224-2410 HUMAN OTC DRUG The Itch Eraser Max Strength DIPHENHYDRAMINE HYDROCHLORIDE SPRAY TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part348 Tender Corporation DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/mL N 20181231 44224-2420_24fc11d4-5d75-2f53-e054-00144ff8d46c 44224-2420 HUMAN OTC DRUG The Itch Eraser Sensitive SODIUM BICARBONATE CREAM TOPICAL 20151117 OTC MONOGRAPH FINAL part347 Tender Corporation SODIUM BICARBONATE 50 mg/g N 20181231 44224-2500_c6534a3b-0e77-4a7c-8c8c-1068cfa3f130 44224-2500 HUMAN OTC DRUG ADVENTURE MEDICAL KITS 1-2 PERSON NATIONAL SKI PATROL FIRST AID BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN KIT 20100826 OTC MONOGRAPH NOT FINAL part333B Tender Corp dba Adventure Medical Kits N 20181231 44224-2999_4a4e2759-49f0-20db-e054-00144ff8d46c 44224-2999 HUMAN OTC DRUG Easy Care First Aid Kit - Comprehensive Ammonia, Aspirin, Diphenhydramine Hydrochloride, Ibuprofen, Acetaminophen, Lidocaine Hydrochloride, Benzalkonium Chloride KIT ORAL; TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333A Tender Corporation N 20181231 44224-3000_b2a273a1-92fa-474f-afc9-1620960ee4e1 44224-3000 HUMAN OTC DRUG ADVENTURE MEDICAL KITS 1-4 PERSON FIRST AID BENZALKONIUM CHLORIDE, ASPIRIN, IBUPROFEN, ISOPROPYL ALCOHOL, BENZOCAINE, SD ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN, DIPHENHYDRAMINE CHLORIDE KIT TOPICAL 20100826 OTC MONOGRAPH NOT FINAL part333B Tender Corp dba Adventure Medical Kits E 20171231 44224-3120_35ce2638-6a78-41dd-e054-00144ff8d46c 44224-3120 HUMAN OTC DRUG Benzocaine and Benzethonium Benzocaine and Benzethonium AEROSOL, SPRAY TOPICAL 20140819 OTC MONOGRAPH NOT FINAL part348 Tender Corporation BENZETHONIUM CHLORIDE; BENZOCAINE 170; 8500 mg/85g; mg/85g N 20181231 44224-3122_35cad32c-947d-6b63-e054-00144ff8d46c 44224-3122 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20140819 OTC MONOGRAPH NOT FINAL part356 Tender Corporation HYDROGEN PEROXIDE 3.57 mL/118mL N 20181231 44224-3300_3fed1b06-722d-6f83-e054-00144ff88e88 44224-3300 HUMAN OTC DRUG After Cuts and Scrapes Lidocaine Hydrochloride, Benzalkonium Chloride SOLUTION TOPICAL 20030711 OTC MONOGRAPH NOT FINAL part333A Tender Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 26; 25 mg/mL; mg/mL N 20181231 44224-3621_407dcddf-1191-25f5-e054-00144ff8d46c 44224-3621 HUMAN OTC DRUG After Bite Wipe Ethyl Alcohol, Lidocaine HCl LIQUID TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part348 Tender Corporation LIDOCAINE HYDROCHLORIDE; ALCOHOL 20; .5 mg/mL; mL/mL N 20181231 44224-5120_490e37af-615a-34e9-e054-00144ff8d46c 44224-5120 HUMAN OTC DRUG After Burn LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20110412 OTC MONOGRAPH NOT FINAL part348 Tender Corporation LIDOCAINE HYDROCHLORIDE 25 mg/mL N 20181231 44237-001_fb9d0cfc-5f50-4856-ab66-7a2e6b804b57 44237-001 HUMAN OTC DRUG Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol LOZENGE ORAL 20100401 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 E 20171231 44237-002_1ea9092b-5431-4031-9e9d-8dbd26215658 44237-002 HUMAN OTC DRUG Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol LOZENGE ORAL 20100401 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 E 20171231 44237-003_c3e67adb-01bc-4baf-bdc2-a09df45a6db8 44237-003 HUMAN OTC DRUG Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol LOZENGE ORAL 20100401 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 E 20171231 44237-004_86d55ddc-81be-4418-a0b0-bc7c6286aaa7 44237-004 HUMAN OTC DRUG Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol LOZENGE ORAL 20100401 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 E 20171231 44237-005_38f54bc1-34c0-4503-b77c-f403c78fc401 44237-005 HUMAN OTC DRUG Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol LOZENGE ORAL 20100401 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 E 20171231 44237-006_47e38c86-dbbe-4aa1-bf0d-403f4ece2c49 44237-006 HUMAN OTC DRUG Linkus Lozenges Cough Suppressant/Oral Anesthetic Menthol LOZENGE ORAL 20100401 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 E 20171231 44237-007_f6aa67eb-5aa4-4ea8-806b-f47da3e4d5f9 44237-007 HUMAN OTC DRUG Sinosil Nasal Decongestant Xylometazoline HCL SPRAY NASAL 20110209 OTC MONOGRAPH FINAL part341 Herbion Pakistan Pvt Ltd XYLOMETAZOLINE HYDROCHLORIDE .015 mL/15mL E 20171231 44237-008_80f2c4e7-f566-428e-89e0-5947102d3d25 44237-008 HUMAN OTC DRUG Herbion Naturals Honey-Lemon Cough Drops Menthol LOZENGE ORAL 20130101 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 1.6 mg/1 E 20171231 44237-009_80f3dfc4-e4a9-44a1-a2de-074469b953d6 44237-009 HUMAN OTC DRUG Herbion Naturals Mint Cough Drops Menthol LOZENGE ORAL 20130101 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 6 mg/1 E 20171231 44237-010_da398452-612f-499c-917f-ef984fce1c08 44237-010 HUMAN OTC DRUG Herbion Naturals Orange Cough Drops Menthol LOZENGE ORAL 20130101 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd. MENTHOL 5 mg/1 E 20171231 44237-013_5165c550-1a06-4932-a136-66a5ecd0dc9d 44237-013 HUMAN OTC DRUG Herbion Naturals Mint Cough Drops Menthol LOZENGE ORAL 20131024 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/1 N 20181231 44237-014_8cc88c49-1039-47a8-af18-655544810f49 44237-014 HUMAN OTC DRUG Herbion Naturals Mint Cough Drops Menthol LOZENGE ORAL 20140423 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-014_8d70bbbf-7de1-4c34-be3f-0399f7d280af 44237-014 HUMAN OTC DRUG Herbion Naturals Mint Cough drops Menthol LOZENGE ORAL 20141219 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-015_007751d3-5e0f-41f5-ac89-261accd0e0ac 44237-015 HUMAN OTC DRUG Herbion Naturals Orange Menthol LOZENGE ORAL 20140415 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/1 N 20181231 44237-016_5cc4549d-2be3-4cb2-8886-845ac895f87d 44237-016 HUMAN OTC DRUG Herbion Naturals Honey Lemon Menthol LOZENGE ORAL 20140415 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/1 N 20181231 44237-017_12f08217-f4d6-40ff-9340-9f95941cc8b3 44237-017 HUMAN OTC DRUG Herbion Naturals Honey lemon Cough Drops Menthol LOZENGE ORAL 20141222 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-018_984a0a92-0e73-4dca-8603-bf62d5f6a938 44237-018 HUMAN OTC DRUG Herbion Naturals orange Cough drops Menthol LOZENGE ORAL 20141222 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-019_eff098d3-d51e-4777-bd84-b5ce6a6595a4 44237-019 HUMAN OTC DRUG Herbion Naturals Honey lemon Cough Drops Menthol LOZENGE ORAL 20141224 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-020_2084c617-9a09-4545-9418-8cb59ac53ba4 44237-020 HUMAN OTC DRUG Herbion Naturals Orange Cough Drops Menthol LOZENGE ORAL 20150101 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-021_3571255c-7487-4db9-8383-441310e1b2e7 44237-021 HUMAN OTC DRUG Herbion Naturals Mint Cough Drops Menthol LOZENGE ORAL 20150101 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-022_6799dfab-ba02-4697-a2a2-6ccb82bb06e9 44237-022 HUMAN OTC DRUG Herbion Naturals Mint Cough drops Menthol LOZENGE ORAL 20151102 OTC MONOGRAPH FINAL part341 Herbion Pakistan (pvt) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-023_2ee314f3-c11c-4d0b-9a17-7b90a853c634 44237-023 HUMAN OTC DRUG Herbion Naturals Honey lemon Cough Drops Menthol LOZENGE ORAL 20151103 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-024_21aec7bd-3295-4828-9cb8-4d790c606e0e 44237-024 HUMAN OTC DRUG Herbion Naturals orange Cough drops Menthol LOZENGE ORAL 20151103 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-025_485cda44-c880-4398-846d-d913ad151988 44237-025 HUMAN OTC DRUG Herbion Naturals Honey lemon Cough Drops Sugar Free Menthol LOZENGE ORAL 20170516 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/1 N 20181231 44237-026_913f8779-31e4-4e51-ba3d-b99ced029ba3 44237-026 HUMAN OTC DRUG Herbion Naturals Orange Cough drops Sugar Free Menthol LOZENGE ORAL 20170517 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-027_5bc3b009-d3a1-4343-a831-6e4b437cfa32 44237-027 HUMAN OTC DRUG Herbion Naturals Cherry Cough Drops Menthol LOZENGE ORAL 20160427 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-028_0cf91036-6468-4dba-a160-466c02817f0f 44237-028 HUMAN OTC DRUG Herbion Naturals Mint Cough drops Sugar Free Menthol LOZENGE ORAL 20160503 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-029_5ecb3a68-cde4-4078-bbd7-d2eb2d260313 44237-029 HUMAN OTC DRUG Herbion Naturals Cherry Cough Drops Menthol LOZENGE ORAL 20160831 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-030_e5006acc-d59f-4a23-a780-c90d898b98a5 44237-030 HUMAN OTC DRUG Herbion Naturals Honey Lemon Cough Drops Menthol LOZENGE ORAL 20160831 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-031_7eb5db56-bf56-4c01-9576-446262f98d49 44237-031 HUMAN OTC DRUG Herbion Naturals Orange Cough Drops Menthol LOZENGE ORAL 20160831 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-032_7845ed2d-ccd6-4729-a288-b5d0dafe804f 44237-032 HUMAN OTC DRUG Herbion Naturals Orange Cough drops Sugar Free Menthol LOZENGE ORAL 20170210 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-033_1127bc1c-2937-480c-b6f3-1a246bf2cc21 44237-033 HUMAN OTC DRUG Herbion Naturals Honey lemon Cough Drops Sugar Free Menthol LOZENGE ORAL 20170224 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/2.51 N 20181231 44237-100_37c61a09-9bee-4b5f-9642-bf6bcb302e28 44237-100 HUMAN OTC DRUG Herbion Naturals Orange Menthol LOZENGE ORAL 20131201 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/1 N 20181231 44237-300_940c54ed-fa54-4903-9498-4d35845b5d24 44237-300 HUMAN OTC DRUG Herbion Naturals Honey Lemon Menthol LOZENGE ORAL 20131024 OTC MONOGRAPH FINAL part341 Herbion Pakistan (Pvt.) Ltd MENTHOL 5.5 mg/1 N 20181231 44237-400_026dcf86-2358-41e1-8886-fd984c5cd531 44237-400 HUMAN OTC DRUG Claree Hand Sanitizer Gel Antiseptic GEL TOPICAL 20100401 OTC MONOGRAPH FINAL part333 Herbion Pakistan (Pvt.) Ltd. ALCOHOL 37 mL/60mL E 20171231 44338-001_8b26670f-3e68-43e7-8ee3-2c2fc6fa100b 44338-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20111212 ANDA ANDA203709 Wisconsin Medical Cyclotron LLC FLUDEOXYGLUCOSE F-18 500 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 44338-002_647f6497-acd7-455e-9bae-3029b2c20b5b 44338-002 HUMAN PRESCRIPTION DRUG Ammonia N 13 Ammonia N-13 INJECTION, SOLUTION INTRAVENOUS 20141223 ANDA ANDA204356 Wisconsin Medical Cyclotron, LLC AMMONIA N-13 260 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 44356-0001_b464387f-3f6b-4895-80c8-1bded4cbefd3 44356-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090926 UNAPPROVED MEDICAL GAS Linco Medical & Supply Inc OXYGEN 99 L/100L E 20171231 44363-1815_61045b8c-432b-4868-bc9f-42f3de524b6a 44363-1815 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19880101 NDA NDA205767 Institutional Care Pharmacy OXYGEN 99 L/100L N 20181231 44376-100_d2cb9eaf-519e-43e7-b24f-7033e6ab7d2e 44376-100 HUMAN OTC DRUG Today Vaginal Contraceptive Nonoxynol-9 SPONGE VAGINAL 19830401 NDA NDA018683 Mayer Laboratories, Inc. NONOXYNOL-9 1000 mg/1 N 20191231 44397-001_886b11d0-6897-49be-b71e-c64c6a2b281d 44397-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19740101 NDA NDA205889 Argyle Welding Supply Company, Inc. OXYGEN 99 L/100L E 20171231 44397-010_f3211ed5-af40-4037-85bb-a3ddceed4257 44397-010 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19740101 UNAPPROVED MEDICAL GAS Argyle Welding Supply Co. Inc. NITROUS OXIDE 99 L/100L E 20171231 44397-011_c25537ad-6191-41ce-99ae-ec359e6c10be 44397-011 HUMAN PRESCRIPTION DRUG nitrogen nitrogen GAS RESPIRATORY (INHALATION) 19740101 NDA NDA205891 Argyle Welding Supply Company, Inc. NITROGEN 99 L/100L E 20171231 44397-020_2ad3a940-2916-494c-8e9f-187916626074 44397-020 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19740101 UNAPPROVED MEDICAL GAS Argyle Welding Supply Co. Inc. NITROGEN 99 L/100L E 20171231 44397-021_7aad3e8f-3620-44c1-8f16-3399a390fc99 44397-021 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19740101 NDA NDA205704 Argyle Welding Supply Company, Inc. NITROUS OXIDE 99 L/100L E 20171231 44517-001_a5f97c54-89c4-45f8-91f0-de95caffa62f 44517-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20081201 NDA NDA205889 Blue Water Industrial Products, Inc. OXYGEN 99 L/100L N 20181231 44517-010_dfb4f3c4-7754-4366-9c61-1284853bb6db 44517-010 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20081201 NDA NDA205891 Blue Water Industrial Products, Inc. NITROGEN 99 L/100L N 20181231 44517-020_62c99ada-c6c7-4c5d-a98e-803133dea6b6 44517-020 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 20081201 NDA NDA209989 Blue Water Industrial Products, Inc. NITROUS OXIDE 99 L/100L N 20181231 44523-415_b32fe71a-4a58-04a1-64d3-bc3cc4a895bf 44523-415 HUMAN PRESCRIPTION DRUG Potassium Citrate potassium citrate TABLET ORAL 20131223 NDA AUTHORIZED GENERIC NDA019071 Biocomp Pharma, Inc. POTASSIUM CITRATE 15 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 44523-425_88bfdb3a-68d1-42c8-b74e-d1513a33ffa6 44523-425 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20120607 NDA AUTHORIZED GENERIC NDA021618 Biocomp Pharma, Inc. TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 44523-450_88bfdb3a-68d1-42c8-b74e-d1513a33ffa6 44523-450 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20120607 NDA AUTHORIZED GENERIC NDA021618 Biocomp Pharma, Inc. TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 44523-510_51f02205-3109-08ce-e054-00144ff88e88 44523-510 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide Sodium Sulfacetamide SHAMPOO TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-520_4c6c2afd-17c5-2615-e054-00144ff8d46c 44523-520 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide, Sulfur SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-535_5200de14-c00c-41f4-e054-00144ff88e88 44523-535 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide, Sulfur SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-542_52557cd0-d13b-683a-e054-00144ff88e88 44523-542 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide, Sulfur SULFACETAMIDE SODIUM CREAM TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-550_51f15267-9786-46a4-e054-00144ff8d46c 44523-550 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide, Sulfur SULFACETAMIDE SODIUM, SULFUR EMULSION TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 20 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-560_53bc7398-ea8a-5869-e054-00144ff8d46c 44523-560 HUMAN PRESCRIPTION DRUG SULFACETAMIDE SODIUM, SULFUR SULFACETAMIDE SODIUM, SULFUR EMULSION TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-568_4e78decf-4076-4e98-e054-00144ff8d46c 44523-568 HUMAN PRESCRIPTION DRUG SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM LIQUID TOPICAL 20110915 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-602_60156415-16d9-402c-e053-2a91aa0a7b93 44523-602 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE AND SULFUR SULFACETAMIDE SODIUM, SULFUR LOTION TOPICAL 20110430 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-603_60155fb3-8a21-3f4c-e053-2a91aa0aec20 44523-603 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE AND SULFUR SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20110430 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 g/g; g/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-604_601615e6-8453-1a05-e053-2a91aa0a88ee 44523-604 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE, SULFUR sulfacetamide sodium, sulfur SUSPENSION TOPICAL 20110604 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-606_4e7a26a6-1eb7-236f-e054-00144ff88e88 44523-606 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE SODIUM SULFACETAMIDE LIQUID TOPICAL 20130107 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-607_60162e0e-c14c-c13a-e053-2991aa0ac5f7 44523-607 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE AND SULFUR SULFACETAMIDE SODIUM, SULFUR LOTION TOPICAL 20110604 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-609_60168a68-4ad1-2e7e-e053-2a91aa0a50af 44523-609 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide and Sulfur sodium sulfacetamide, sulfur KIT TOPICAL 20110415 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. N 20181231 44523-612_60260b4d-d592-b154-e053-2991aa0a8da5 44523-612 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide, Sulfur SODIUM SULFACETAMIDE, SULFUR CLOTH TOPICAL 20090101 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFUR; SULFACETAMIDE SODIUM 40; 100 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-613_195ceb64-8837-1b63-e054-00144ff88e88 44523-613 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE SODIUM SULFACETAMIDE LIQUID TOPICAL 20110907 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 44523-616_6016d1da-5c8e-7acc-e053-2a91aa0a3e57 44523-616 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide and Sulfur sodium sulfacetamide, sulfur, avobenzone octinoxate, octisalate KIT TOPICAL 20110415 UNAPPROVED DRUG OTHER BioComp Pharma, Inc. N 20181231 44523-732_878e22cc-9f69-3074-3212-2b36763b2a65 44523-732 HUMAN PRESCRIPTION DRUG BioFerr 90 Dual-Iron TABLET, FILM COATED ORAL 20140701 UNAPPROVED DRUG OTHER Biocomp Pharma, Inc. ASCORBIC ACID; IRON PENTACARBONYL; DOCUSATE SODIUM; FERROUS GLUCONATE; FOLIC ACID; CYANOCOBALAMIN 138; 88.5; 55; 13.2; 1.4; 16.8 mg/1; mg/1; mg/1; mg/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 44523-825_14266e97-674b-b6a9-37a2-a955f0a01c4f 44523-825 HUMAN PRESCRIPTION DRUG carbinoxamine maleate carbinoxamine maleate TABLET ORAL 20110527 ANDA ANDA090756 Biocomp Pharma, Inc. CARBINOXAMINE MALEATE 4 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 44567-101_4daf3a64-cd3a-4394-823a-c164578b2c76 44567-101 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120510 ANDA ANDA063146 WG Critical Care, LLC AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 44567-102_4daf3a64-cd3a-4394-823a-c164578b2c76 44567-102 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120510 ANDA ANDA062772 WG Critical Care, LLC AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 44567-103_4daf3a64-cd3a-4394-823a-c164578b2c76 44567-103 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120510 ANDA ANDA063140 WG Critical Care, LLC AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 44567-104_9e6b39be-f5e6-4d20-9cdb-c8d6ba2384f4 44567-104 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120510 ANDA ANDA063142 WG Critical Care, LLC AMPICILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 44567-210_e51138bd-cb36-487a-8690-6003c604a9db 44567-210 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051130 ANDA ANDA065176 WG Critical Care, LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 44567-211_e51138bd-cb36-487a-8690-6003c604a9db 44567-211 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051130 ANDA ANDA065176 WG Critical Care, LLC SULBACTAM SODIUM; AMPICILLIN SODIUM 1; 2 g/20mL; g/20mL beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 44567-212_4c7ac8d5-2371-4d2d-8431-9af411535348 44567-212 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin and Sulbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20051125 ANDA ANDA065188 WG Critical Care, LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 10; 5 g/100mL; g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 44567-221_8d4f95a8-d18e-4ca7-99ef-9ef5809cd1b4 44567-221 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130118 ANDA ANDA090560 WG Critical Care, LLC NAFCILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 44567-222_8d4f95a8-d18e-4ca7-99ef-9ef5809cd1b4 44567-222 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130118 ANDA ANDA090560 WG Critical Care, LLC NAFCILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 44567-223_7bb40777-926b-4ea7-868d-12a9e9b72e74 44567-223 HUMAN PRESCRIPTION DRUG Nafcillin NAFCILLIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110427 ANDA ANDA090005 WG Critical Care, LLC NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 44567-235_e03f50e0-7798-4d9e-a07a-8282c6125c5b 44567-235 HUMAN PRESCRIPTION DRUG Ceftazidime Ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171026 ANDA ANDA062640 WG Critical Care, LLC CEFTAZIDIME 1 g/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-236_e03f50e0-7798-4d9e-a07a-8282c6125c5b 44567-236 HUMAN PRESCRIPTION DRUG Ceftazidime Ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20171026 ANDA ANDA062640 WG Critical Care, LLC CEFTAZIDIME 2 g/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-237_250aa1a6-5e79-45c6-92b3-b14c558666ac 44567-237 HUMAN PRESCRIPTION DRUG Ceftazidime Ceftazidime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20130131 ANDA ANDA062640 WG Critical Care, LLC CEFTAZIDIME 6 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-240_33dc9525-31fa-44da-8e1e-2a027626b890 44567-240 HUMAN PRESCRIPTION DRUG Cefepime Cefepime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141010 ANDA ANDA065441 WG Critical Care, LLC CEFEPIME HYDROCHLORIDE 1 g/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-241_33dc9525-31fa-44da-8e1e-2a027626b890 44567-241 HUMAN PRESCRIPTION DRUG Cefepime Cefepime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20141010 ANDA ANDA065441 WG Critical Care, LLC CEFEPIME HYDROCHLORIDE 2 g/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-245_658a0dc6-6da5-44dc-94f2-1211619297f7 44567-245 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20150218 ANDA ANDA065414 WG Critical Care, LLC CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-245_91ac4c14-8dd8-4efe-a462-d1c488a6184f 44567-245 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170710 ANDA ANDA065414 WG Critical Care, LLC CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-246_658a0dc6-6da5-44dc-94f2-1211619297f7 44567-246 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20150218 ANDA ANDA065414 WG Critical Care, LLC CEFOXITIN SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-246_91ac4c14-8dd8-4efe-a462-d1c488a6184f 44567-246 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170710 ANDA ANDA065414 WG Critical Care, LLC CEFOXITIN SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-247_f5288962-caee-4771-8229-df9cdefcfa67 44567-247 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20131001 ANDA ANDA065415 WG Critical Care, LLC CEFOXITIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-310_f27a91a3-3a1b-4a23-b113-1e93ca3ee40f 44567-310 HUMAN PRESCRIPTION DRUG Penicillin G Potassium Penicillin G Potassium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120510 ANDA ANDA065149 WG Critical Care, LLC PENICILLIN G POTASSIUM 1000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 44567-311_f27a91a3-3a1b-4a23-b113-1e93ca3ee40f 44567-311 HUMAN PRESCRIPTION DRUG Penicillin G Potassium Penicillin G Potassium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120510 ANDA ANDA065149 WG Critical Care, LLC PENICILLIN G POTASSIUM 5000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 44567-312_f27a91a3-3a1b-4a23-b113-1e93ca3ee40f 44567-312 HUMAN PRESCRIPTION DRUG Penicillin G Potassium Penicillin G Potassium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120510 ANDA ANDA065149 WG Critical Care, LLC PENICILLIN G POTASSIUM 20000000 [iU]/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 44567-410_79f595cf-1da9-4aa1-bb44-4dcfaa559414 44567-410 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION INTRAVENOUS 20160308 ANDA ANDA207349 WG Critical Care, LLC MAGNESIUM SULFATE HEPTAHYDRATE 1 g/100mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 44567-420_752f55bb-c4ca-4545-94b3-3deea66888d4 44567-420 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION INTRAVENOUS 20180109 ANDA ANDA207350 WG Critical Care, LLC MAGNESIUM SULFATE HEPTAHYDRATE 2 g/50mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 44567-421_752f55bb-c4ca-4545-94b3-3deea66888d4 44567-421 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION INTRAVENOUS 20180109 ANDA ANDA207350 WG Critical Care, LLC MAGNESIUM SULFATE HEPTAHYDRATE 4 g/100mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 44567-422_752f55bb-c4ca-4545-94b3-3deea66888d4 44567-422 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION INTRAVENOUS 20180109 ANDA ANDA207350 WG Critical Care, LLC MAGNESIUM SULFATE HEPTAHYDRATE 20 g/500mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 44567-423_752f55bb-c4ca-4545-94b3-3deea66888d4 44567-423 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION INTRAVENOUS 20180109 ANDA ANDA207350 WG Critical Care, LLC MAGNESIUM SULFATE HEPTAHYDRATE 40 g/1000mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 44567-424_752f55bb-c4ca-4545-94b3-3deea66888d4 44567-424 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION INTRAVENOUS 20180109 ANDA ANDA207350 WG Critical Care, LLC MAGNESIUM SULFATE HEPTAHYDRATE 4 g/50mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 44567-435_064f74e8-53b7-44d3-9acf-af67066db005 44567-435 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20160414 ANDA ANDA090343 WG Critical Care, LLC LEVOFLOXACIN 5 mg/mL N 20181231 44567-436_064f74e8-53b7-44d3-9acf-af67066db005 44567-436 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20160414 ANDA ANDA090343 WG Critical Care, LLC LEVOFLOXACIN 5 mg/mL N 20181231 44567-437_064f74e8-53b7-44d3-9acf-af67066db005 44567-437 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20160414 ANDA ANDA090343 WG Critical Care, LLC LEVOFLOXACIN 5 mg/mL N 20181231 44567-504_909339e7-d3cb-4c6a-a425-e21ecc877370 44567-504 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION INTRAVENOUS 20130711 NDA NDA020262 WG Critical Care, LLC PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 44567-505_909339e7-d3cb-4c6a-a425-e21ecc877370 44567-505 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION INTRAVENOUS 20130711 NDA NDA020262 WG Critical Care, LLC PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 44567-506_909339e7-d3cb-4c6a-a425-e21ecc877370 44567-506 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION INTRAVENOUS 20130711 NDA NDA020262 WG Critical Care, LLC PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 44567-507_82247827-8839-456f-be47-0593ebf13214 44567-507 HUMAN PRESCRIPTION DRUG Teniposide Teniposide INJECTION, SOLUTION INTRAVENOUS 20130430 NDA NDA020119 WG Critical Care, LLC TENIPOSIDE 10 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 44567-509_2308221c-f942-4c1e-a9f9-2ba58c43d362 44567-509 HUMAN PRESCRIPTION DRUG CISplatin CISplatin INJECTION, SOLUTION INTRAVENOUS 20120113 NDA NDA018057 WG Critical Care, LLC CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 44567-510_2308221c-f942-4c1e-a9f9-2ba58c43d362 44567-510 HUMAN PRESCRIPTION DRUG CISplatin CISplatin INJECTION, SOLUTION INTRAVENOUS 20120113 NDA NDA018057 WG Critical Care, LLC CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 44567-511_2308221c-f942-4c1e-a9f9-2ba58c43d362 44567-511 HUMAN PRESCRIPTION DRUG CISplatin CISplatin INJECTION, SOLUTION INTRAVENOUS 20150415 NDA NDA018057 WG Critical Care, LLC CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 44567-600_1bebd11d-f1de-45b6-ab00-3d261d59264e 44567-600 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160419 NDA NDA206628 WG Critical Care, LLC DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 44567-601_1bebd11d-f1de-45b6-ab00-3d261d59264e 44567-601 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160419 NDA NDA206628 WG Critical Care, LLC DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 44567-700_d56b6880-c756-45b5-94cb-c6506a16592b 44567-700 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080724 ANDA ANDA065329 WG Critical Care, LLC CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-701_d56b6880-c756-45b5-94cb-c6506a16592b 44567-701 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080724 ANDA ANDA065329 WG Critical Care, LLC CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-702_d56b6880-c756-45b5-94cb-c6506a16592b 44567-702 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080724 ANDA ANDA065329 WG Critical Care, LLC CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-703_d317080b-5b6c-47fc-8428-52973c0580d3 44567-703 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080724 ANDA ANDA065328 WG Critical Care, LLC CEFTRIAXONE SODIUM 10 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-706_2fbcb9e8-836c-4251-af4e-f1c0fe2e540f 44567-706 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150306 ANDA ANDA065303 WG Critical Care, LLC CEFAZOLIN SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-707_2fbcb9e8-836c-4251-af4e-f1c0fe2e540f 44567-707 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150306 ANDA ANDA065303 WG Critical Care, LLC CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-708_aab71ed1-9238-4ec7-b0ad-0a69dfb4ed02 44567-708 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20150306 ANDA ANDA065306 WG Critical Care, LLC CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 44567-710_4d14b1a4-39d2-4e96-b84d-e193fbc99b16 44567-710 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121004 ANDA ANDA064125 WG Critical Care, LLC CEFUROXIME SODIUM 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 44567-711_4d14b1a4-39d2-4e96-b84d-e193fbc99b16 44567-711 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121004 ANDA ANDA064125 WG Critical Care, LLC CEFUROXIME SODIUM 1.5 g/16mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 44567-712_e4a6cecb-b7bd-4e27-9535-4ab73c2ccc00 44567-712 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121004 ANDA ANDA064124 WG Critical Care, LLC CEFUROXIME SODIUM 7.5 g/80mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 44567-720_4d14b1a4-39d2-4e96-b84d-e193fbc99b16 44567-720 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121004 ANDA ANDA064125 WG Critical Care, LLC CEFUROXIME SODIUM 750 mg/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 44567-722_4d14b1a4-39d2-4e96-b84d-e193fbc99b16 44567-722 HUMAN PRESCRIPTION DRUG Cefuroxime Cefuroxime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121004 ANDA ANDA064125 WG Critical Care, LLC CEFUROXIME SODIUM 1.5 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 44567-801_539e5c29-85bd-4332-8c7d-a42f5a5f5eec 44567-801 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 WG Critical Care, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 44567-802_539e5c29-85bd-4332-8c7d-a42f5a5f5eec 44567-802 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 WG Critical Care, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 44567-803_539e5c29-85bd-4332-8c7d-a42f5a5f5eec 44567-803 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 WG Critical Care, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 44567-804_ae6ace4a-9fac-459c-a099-9881210016b4 44567-804 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin and Tazobactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091020 ANDA ANDA090498 WG Critical Care, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 36; 4.5 g/180mL; g/180mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 44567-811_60b10020-f802-4fef-a487-0f11eca246c5 44567-811 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride Esmolol Hydrochloride INJECTION INTRAVENOUS 20171204 NDA NDA205703 WG Critical Care, LLC ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 44567-812_60b10020-f802-4fef-a487-0f11eca246c5 44567-812 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride Esmolol Hydrochloride INJECTION INTRAVENOUS 20171204 NDA NDA205703 WG Critical Care, LLC ESMOLOL HYDROCHLORIDE 20 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 44577-001_48063228-ea03-498c-e054-00144ff88e88 44577-001 HUMAN OTC DRUG CLARUS Antifungal TOLNAFTATE CREAM TOPICAL 20120607 OTC MONOGRAPH FINAL part333C Clinical Therapeutic Solutions TOLNAFTATE 1 g/100g N 20181231 44577-002_480628ca-cfbe-001b-e054-00144ff8d46c 44577-002 HUMAN OTC DRUG CLARUS Antifungal TOLNAFTATE SOLUTION TOPICAL 20120607 OTC MONOGRAPH FINAL part333C Clinical Therapeutic Solutions TOLNAFTATE 1 g/100mL N 20181231 44577-020_480628ca-cfce-001b-e054-00144ff8d46c 44577-020 HUMAN OTC DRUG VerruStat Wart Remover SALICYLIC ACID LIQUID TOPICAL 20131016 OTC MONOGRAPH FINAL part358B Clinical Therapeutic Solutions SALICYLIC ACID 170 mg/mL N 20181231 44577-040_48bc8512-f91a-451b-e054-00144ff8d46c 44577-040 HUMAN OTC DRUG VerruStat Medicated Plantar Pads SALICYLIC ACID PATCH TOPICAL 20131016 OTC MONOGRAPH FINAL part358B Clinical Therapeutic Solutions SALICYLIC ACID .4 g/100g N 20181231 44577-205_480628ca-d025-001b-e054-00144ff8d46c 44577-205 HUMAN OTC DRUG MacerRx Web MICONAZOLE NITRATE CREAM TOPICAL 20130606 OTC MONOGRAPH FINAL part333C Clinical Therapeutic Solutions MICONAZOLE NITRATE 2 g/100g N 20181231 44577-623_480628ca-cfd9-001b-e054-00144ff8d46c 44577-623 HUMAN OTC DRUG KERA HC HYDROCORTISONE CREAM TOPICAL 20121017 OTC MONOGRAPH NOT FINAL part348 Clinical Therapeutic Solutions HYDROCORTISONE 1 g/100g N 20181231 44577-704_480628ca-cfe8-001b-e054-00144ff8d46c 44577-704 HUMAN OTC DRUG LidoStat LIDOCAINE HCL CREAM TOPICAL 20130619 OTC MONOGRAPH NOT FINAL part348 Clinical Therapeutic Solutions LIDOCAINE HYDROCHLORIDE 40 mg/g N 20181231 44577-711_492419ef-c64d-3880-e054-00144ff8d46c 44577-711 HUMAN OTC DRUG TRI-SOFT SOFTENING BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E Clinical Therapeutic Solutions BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 44597-5358_e0d6456f-1308-4c97-b2c0-228534403621 44597-5358 HUMAN OTC DRUG Herbon Wild Cherry Menthol and Echinacea LOZENGE ORAL 20090930 OTC MONOGRAPH FINAL part341 Purity Life Division of SunOpta MENTHOL; ECHINACEA 2; 100 mg/1; mg/1 E 20171231 44597-5505_a3fd4c19-574d-4aee-bae9-4c9972da6fe9 44597-5505 HUMAN OTC DRUG Herbon Glacial Mint Echinacea Purpurea, Menthol, and Eucalyptus Oil LOZENGE ORAL 20090930 OTC MONOGRAPH FINAL part341 Purity Life Division of SunOpta ECHINACEA PURPUREA; MENTHOL; EUCALYPTUS OIL 7.35; 10; 6 mg/1; mg/1; mg/1 E 20171231 44597-5535_fad6077b-2fc9-4017-b8f8-b9b95ccb5856 44597-5535 HUMAN OTC DRUG Herbon Sugar Free Lemon Honey Menthol and Echinacea Purpurea LOZENGE ORAL 20090930 OTC MONOGRAPH FINAL part341 Purity Life Division of SunOpta Co. MENTHOL; ECHINACEA PURPUREA 8; 7.35 mg/1; mg/1 E 20171231 44597-5605_e1937a4f-018f-44d5-a101-536edf4a5fbc 44597-5605 HUMAN OTC DRUG Herbon Berry Buddies/Watermelon Goodypops Pectin and Echinacea Purpurea LOZENGE ORAL 20090930 OTC MONOGRAPH FINAL part341 Purity Life Division of SunOpta PECTIN; ECHINACEA PURPUREA 10; 50 mg/1; mg/1 E 20171231 44647-032_6fdd8704-f1f7-4d5d-a2c2-e0d2fad37032 44647-032 HUMAN PRESCRIPTION DRUG MEROPENEM MEROPENEM INJECTION INTRAVENOUS 20160419 ANDA ANDA206086 Savior Lifetec Corporation MEROPENEM 500 mg/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 44647-033_6fdd8704-f1f7-4d5d-a2c2-e0d2fad37032 44647-033 HUMAN PRESCRIPTION DRUG MEROPENEM MEROPENEM INJECTION INTRAVENOUS 20160419 ANDA ANDA206086 Savior Lifetec Corporation MEROPENEM 1 g/30mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 44662-3111_f1ad775d-b008-4491-b830-3bc6ed3a3eab 44662-3111 HUMAN OTC DRUG Antimicrobial alcohol LIQUID TOPICAL 20131030 OTC MONOGRAPH NOT FINAL part333E Hopkins Medical ALCOHOL 700 mL/L N 20181231 44717-148_8d3fe2c3-2205-4bf6-aedc-c90d2b27d938 44717-148 HUMAN OTC DRUG Age Defying Blemish Treatment Salicylic Acid CREAM TOPICAL 20131024 OTC MONOGRAPH FINAL part358H Wasatch Product Development, LLC SALICYLIC ACID 2 g/100mL E 20171231 44717-532_05c929d2-f4fd-4b0b-8cb9-0c2f50a8610c 44717-532 HUMAN OTC DRUG Natures Sunshine Products Everflex Topical Analgesic Pain Relief Menthol CREAM TOPICAL 20100813 OTC MONOGRAPH NOT FINAL part348 Wasatch Product Development, LLC MENTHOL 1.25 g/100g E 20171231 44717-533_46a00fb6-410c-48a8-bc01-f78798790da9 44717-533 HUMAN OTC DRUG Natria Nourishing Daily Defense Ethylhexyl Methoxycinnamate, Zinc Oxide CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 Wasatch Product Development OCTINOXATE; ZINC OXIDE 7.5; 2.5 mL/100mL; mL/100mL E 20171231 44717-535_5b0cf83e-5231-4d7b-bd21-312348a7d201 44717-535 HUMAN OTC DRUG Natria Acne Treatment Salicylic Acid CREAM TOPICAL 20100628 OTC MONOGRAPH NOT FINAL part333 Wasatch Product Development, Inc. SALICYLIC ACID 30 mL/100mL E 20171231 44717-536_1ef931a4-35c1-4f41-a2c1-08c5b835a8fe 44717-536 HUMAN OTC DRUG Tahitian Noni Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100628 OTC MONOGRAPH NOT FINAL part352 Wasatch Product Development AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 6.5; 7; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 44717-538_9412749c-b788-4b7f-8b54-7503da58fb93 44717-538 HUMAN OTC DRUG Natria Brightening SPF 15 Ethylhexl Methoxycinnamate, Zinc Oxide CREAM TOPICAL 20100719 OTC MONOGRAPH NOT FINAL part352 Wasatch Product Development OCTINOXATE; ZINC OXIDE 7.5; 2.5 mL/100mL; mL/100mL E 20171231 44717-890_2ca353c6-a7ee-4e40-b943-729af882a3cb 44717-890 HUMAN OTC DRUG Canker Complete Canker Sore Relief Menthol CREAM TOPICAL 20101012 OTC MONOGRAPH FINAL part341 Wasatch Product Development MENTHOL .5 g/100g N 20181231 44738-4001_146504fc-a0de-446c-911d-660248fd8f01 44738-4001 HUMAN OTC DRUG Ginsamin Memory ginkgo leaf extract CAPSULE ORAL 20100306 UNAPPROVED DRUG OTHER BioGrand Co., Ltd GINKGO; ASIAN GINSENG 100.2; 75 mg/1; mg/1 E 20171231 44738-5001_d6d2fa42-3753-46dc-81a0-d2d370338c82 44738-5001 HUMAN OTC DRUG Ginsamin Health ginsamin health ginkgo leaf extract CAPSULE ORAL 20100307 UNAPPROVED DRUG OTHER Biogrand Co., Ltd GINKGO; ASIAN GINSENG 90; 75 mg/300mg; mg/300mg E 20171231 44738-6001_a8c08cd0-c00a-4aa2-9225-66b13db3f98c 44738-6001 HUMAN OTC DRUG Ginsamin Beauty ginkgo leaf extract GRANULE ORAL 20100307 UNAPPROVED DRUG OTHER Biogrand Co., Ltd GINKGO; ASIAN GINSENG; N-ACETYLGLUCOSAMINE; HYALURONIC ACID 150; 150; 200; 60 mg/2000mg; mg/2000mg; mg/2000mg; mg/2000mg E 20171231 44738-7001_2cbb9cc7-24c2-41d0-865d-00779a30809e 44738-7001 HUMAN OTC DRUG Ginsamin Energy ginkgo leaf extract LIQUID ORAL 20100307 UNAPPROVED DRUG OTHER Biogrand Co., Ltd GINKGO; ASIAN GINSENG; CREATINE; TAURINE; ASCORBIC ACID 160; 200; 10000; 1000; 1000 mg/20g; mg/20g; mg/20g; mg/20g; mg/20g E 20171231 44738-8001_263a6b61-1c3f-4059-9055-3fac0e5306f1 44738-8001 HUMAN OTC DRUG Ginsamin Power ginkgo leaf extract TABLET ORAL 20100307 UNAPPROVED DRUG OTHER Biogrand Co., Ltd GINKGO; ASIAN GINSENG; 1-OCTACOSANOL; ZINC 80.4; 118.2; 3; 5.4 mg/1; mg/1; mg/1; mg/1 E 20171231 44781-110_e18799bc-0be5-4444-9d07-1808ebb134c5 44781-110 HUMAN OTC DRUG ESOPINIO SUN SHIELD PLUS SPF 35 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 ZION SYNTHETIC FIBER CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.55; 1.4 mL/70mL; mL/70mL E 20171231 44781-120_43654868-5319-4987-8fbd-d568d17eaa0f 44781-120 HUMAN OTC DRUG WRINKLESS PLUS CT-1 LIFTING UP ESSENCE DIMETHICONE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. DIMETHICONE .45 mL/45mL E 20171231 44781-130_62088037-9364-47f9-a9ac-dc8f78c245a2 44781-130 HUMAN OTC DRUG BIOWHITE BEAUTY SERUM ALLANTOIN CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. ALLANTOIN .2 g/40g E 20171231 44781-140_e2ff4509-12eb-46a9-9a2f-e1b36786e09a 44781-140 HUMAN OTC DRUG ESOPINIO FRESH AND CLEAR FOUNDATION SPF20 TITANIUM DIOXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 ZION SYNTHETIC FIBER CO., LTD. TITANIUM DIOXIDE 3.5 g/35g E 20171231 44781-150_2ec37f00-c67c-4c69-9cd8-73d326db80e1 44781-150 HUMAN OTC DRUG WRINKLESS CT-1 EYE DIMETHICONE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. DIMETHICONE .3 g/30g E 20171231 44781-160_00e63613-bce5-48ec-9e61-99c2b1e7f263 44781-160 HUMAN OTC DRUG BIOWHITE BRIGHTENING ESSENCE DIMETHICONE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. DIMETHICONE .5 mL/50mL E 20171231 44781-170_22a29026-beca-4096-a8d1-d814c72312d7 44781-170 HUMAN OTC DRUG ESOPINIO ANIMATING WATER Dimethicone CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. DIMETHICONE .55 g/55g E 20171231 44781-180_72a4ebde-71f4-4379-a2bd-9f147ae9dc00 44781-180 HUMAN OTC DRUG REBIRTH HAIR PYRITHIONE ZINC SHAMPOO CUTANEOUS 20100401 OTC MONOGRAPH FINAL part358H ZION SYNTHETIC FIBER CO., LTD. PYRITHIONE ZINC .6 mL/360mL E 20171231 44781-190_e2761238-41a4-4e30-b274-557539924c20 44781-190 HUMAN OTC DRUG REBIRTH HAIR TONIC WITCH HAZEL SOLUTION CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. WITCH HAZEL .13 mL/130mL E 20171231 44781-200_4799401f-7c45-49dd-bba0-4151441a1a3e 44781-200 HUMAN OTC DRUG ESOPINIO JEWEL WITCH HAZEL SOAP CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. WITCH HAZEL .12 g/120g E 20171231 44781-210_f7ec0ec5-46bb-45a8-a125-9181ed0e16f4 44781-210 HUMAN OTC DRUG BIOWHITE RESILIENT MASSAGE DIMETHICONE CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part347 ZION SYNTHETIC FIBER CO., LTD. DIMETHICONE 4.27 g/95g E 20171231 44781-220_e8c2593f-791d-4a03-b7ba-f86f17ef1851 44781-220 HUMAN OTC DRUG RORIS SHINY CC SPF37 PA PLUS PLUS PLUS Titanium Dioxide, Zinc Oxide, Ethylhexyl Methoxycinnamate CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 ZION SYNTHETIC FIBER CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.87; 3.75; 1.5 g/50g; g/50g; g/50g E 20171231 44781-230_50b5c01b-65de-4ec4-b95a-550585ea2205 44781-230 HUMAN OTC DRUG Esopinio Topaz Phyto Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20130601 OTC MONOGRAPH FINAL part355 ZION SYNTHETIC FIBER CO., LTD. SODIUM MONOFLUOROPHOSPHATE .91 g/120g E 20171231 44781-447_2e7c2d4f-ea08-4398-affe-2548560fa48d 44781-447 HUMAN OTC DRUG Escopinio PHYTO alpha Toothpaste SODIUM MONOFLUOROPHOSPHATE PASTE ORAL 20100121 OTC MONOGRAPH FINAL part355 Zion Synthetic Fiber Corporation Limited SODIUM MONOFLUOROPHOSPHATE .912 g/120g E 20171231 44827-301_0691d246-5df7-4d84-bd2a-d10bb09db1a0 44827-301 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19940301 UNAPPROVED DRUG OTHER Valesco Pharmaceuticals LLC. EPINEPHRINE HYDROCHLORIDE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 44827-303_3cafda9b-8946-41d8-9687-8fa4c9d4b64a 44827-303 HUMAN PRESCRIPTION DRUG Dehydrated Alcohol Dehydrated alcohol injection SOLUTION INTRASPINAL 19900930 UNAPPROVED DRUG OTHER Valesco Pharmaceuticals ALCOHOL .98 mL/mL E 20171231 44873-006_64e54c65-de8b-4e47-a7b8-dff01fc49dc3 44873-006 HUMAN OTC DRUG Go Smile REFRESH SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20151027 OTC MONOGRAPH FINAL part355 Go Smile, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20191231 44873-007_045d1040-732e-4695-9166-5fd63908cf48 44873-007 HUMAN OTC DRUG Go Smile RELAX SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20110505 OTC MONOGRAPH FINAL part355 Go Smile, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20191231 44873-008_760cd2eb-f92e-4a15-a7a9-b79dd2b90c8b 44873-008 HUMAN OTC DRUG Go Smile MINT SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 20160504 OTC MONOGRAPH FINAL part355 Go Smile, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20191231 44911-0001_4bbf8d41-4c63-48c6-8aa2-a8a926e11a47 44911-0001 HUMAN OTC DRUG Arthritis HP Apis mellifica, Bryonia, Causticum, Colchicum autumnale, Kali carbonicum, Kalmia latifolia, Ledum palustre, Pulsatilla, Rhododendron chrysanthum, Rhus toxicodendron, LIQUID ORAL 20120423 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; BRYONIA ALBA ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0002_b76a4b0c-d96d-495f-8c70-cd8d2870cb7f 44911-0002 HUMAN OTC DRUG GABA Phenolic Gamma-Aminobutyric Acid LIQUID ORAL 20120427 UNAPPROVED HOMEOPATHIC Energique, Inc. .GAMMA.-AMINOBUTYRIC ACID 6 [hp_X]/mL N 20191231 44911-0003_d103202b-d3d8-4269-b6d1-93fb1af11bb3 44911-0003 HUMAN OTC DRUG Grippe HP Aconitum Napellus, Arsenicum Album, Baptisia Tinctoria, Belladonna, Bryonia (Alba), Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens LIQUID ORAL 20120427 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0004_c9e15fd0-02cb-4110-ab75-67f6f5fa1dab 44911-0004 HUMAN OTC DRUG BAC HP Apis mellifica, Arsenicum album, Belladonna, Chamomilla, Echinacea, Lachesis mutus, Mercurius solubilis, Pulsatilla, Pyrogenium, Rhus toxicodendron, Silicea, LIQUID ORAL 20120427 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0005_40299f6e-7d65-4182-9a93-bfa6693aac99 44911-0005 HUMAN OTC DRUG Allerstat I Chelidonium Majus, Echinacea, Gentiana Lutea, Arsenicum Album, Carbo Vegetablis, Lycopodium Clavatum LIQUID ORAL 20130311 UNAPPROVED HOMEOPATHIC Energique, Inc. CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GENTIANA LUTEA ROOT; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0006_3331dbf9-64fb-450a-a39c-9972a64ba8ea 44911-0006 HUMAN OTC DRUG Dust Mix Antigens Barley, Corn, House, Mattress, Millet, Milo, Oat, Rice, Rug, Upholstery, Wheat, Arsenicum album, Blatta orientalis, Drosera, Lycopodium clavatum, Pothos foetidus, Pulsatilla, LIQUID ORAL 20120504 UNAPPROVED HOMEOPATHIC Energique, Inc. BARLEY; CORN; HOUSE DUST; MILLET; SORGHUM; OAT; BROWN RICE; WHEAT; ARSENIC TRIOXIDE; BLATTA ORIENTALIS; LYCOPODIUM CLAVATUM SPORE; SYMPLOCARPUS FOETIDUS ROOT; PULSATILLA VULGARIS; DROSERA ROTUNDIFOLIA 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0007_b542f7de-4e28-4f7a-8b05-2ec8c6345ced 44911-0007 HUMAN OTC DRUG Bronchi HP Carbo vegetabilis, Cuprum metallicum Drosera, Hepar sulphuris calcareum, Ipecacuanha, Lachesis mutus, Lobelia inflata, Phosphorus, Pulsatilla, Rumex crispus, Spongia tosta, LIQUID ORAL 20120523 UNAPPROVED HOMEOPATHIC Energique, Inc. ACTIVATED CHARCOAL; COPPER; DROSERA ANGLICA; CALCIUM SULFIDE; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0008_b16f0ea6-3db4-417e-bf8c-915aa408513c 44911-0008 HUMAN OTC DRUG Bactestat Baptisia tinctoria, Echinacea, Phytolacca decandra, Aconitum napellus, Arsenicum album, Belladonna, Ferrum phosphoricum, Lachesis mutus, Phosphorus, LIQUID ORAL 20120524 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; PHYTOLACCA AMERICANA ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; PHOSPHORUS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0009_406b34b9-75b0-43be-a15a-8a945504c499 44911-0009 HUMAN OTC DRUG Parasite Detox Filix mas, Granatum, Juglans regia, Rhamnus purshiana, Absinthium, Aesculus hippocastanum, Arsenicum album, Baptisia tinctoria, Cina, Cuprum metallicum, Ipecacuanha, Lycopodium clavatum, Mercurius vivus, Nux vomica, LIQUID ORAL 20120619 UNAPPROVED HOMEOPATHIC Energique, Inc. DRYOPTERIS FILIX-MAS ROOT; PUNICA GRANATUM ROOT BARK; JUGLANS REGIA FLOWERING TOP; FRANGULA PURSHIANA BARK; WORMWOOD; HORSE CHESTNUT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ARTEMISIA CINA FLOWER; COPPER; IPECAC; LYCOPODIUM CLAVATUM SPORE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; KRAMERIA LAPPACEA ROOT; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SANTONIN; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TEUCRIUM MARUM 3; 3; 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0010_3e0395cc-63f5-4c14-a9b9-40b14a558566 44911-0010 HUMAN OTC DRUG Liver Gallbladder HP Belladonna, Carduus Marianus, Chelidonium Majus, Colocynthis, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus, Pulsatilla, Veratrum Album LIQUID ORAL 20120628 UNAPPROVED HOMEOPATHIC Energique, Inc. ATROPA BELLADONNA; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0011_ab628a94-9c21-4fa5-97a1-c7910cbeb31a 44911-0011 HUMAN PRESCRIPTION DRUG Animal Antigens Canary feathers, Cat hair, Cattle epithelia, Chicken feathers, Dog epithelia, Duck feathers, Gerbil epithelia, Goat epithelia, Goose feathers, LIQUID ORAL 20120803 UNAPPROVED HOMEOPATHIC Energique, Inc. SERINUS CANARIA FEATHER; FELIS CATUS HAIR; BOS TAURUS SKIN; GALLUS GALLUS FEATHER; CANIS LUPUS FAMILIARIS SKIN; ANAS PLATYRHYNCHOS FEATHER; MERIONES UNGUICULATUS SKIN; CAPRA HIRCUS SKIN; ANSER ANSER FEATHER; CAVIA PORCELLUS SKIN; MESOCRICETUS AURATUS SKIN; SUS SCROFA SKIN; EQUUS CABALLUS SKIN; MUS MUSCULUS SKIN; MELOPSITTACUS UNDULATUS FEATHER; ORYCTOLAGUS CUNICULUS SKIN; RATTUS NORVEGICUS SKIN; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 44911-0012_581ba8f6-4370-4d82-91c7-efae9b8d2da6 44911-0012 HUMAN OTC DRUG Lyme HP Baptisia tinctoria, Echinacea, Hydrastis canadensis, Lym D Nosode, Arsenicum album, Bryonia, Chelidonium majus, Colchicum autumnale, Kalmia latifolia, Ledum palustre, Lycopodium clavatum, Phosphorus, Rhus toxicodendron, LIQUID ORAL 20120620 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; NEISSERIA MENINGITIDIS; JAPANESE ENCEPHALITIS VIRUS; HEPATITIS B VIRUS; BORRELIA BURGDORFERI; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; GOLDENSEAL 3; 3; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 44911-0013_848467f3-9859-47aa-9af8-21914a2392c5 44911-0013 HUMAN OTC DRUG Quercetin Phenolic Quercetin, LIQUID ORAL 20120605 UNAPPROVED HOMEOPATHIC Energique, Inc. QUERCETIN 6 [hp_X]/mL N 20181231 44911-0014_d4b46ebc-4f8c-4d84-a62d-4d4e4a2a3338 44911-0014 HUMAN OTC DRUG SP Brosimum Acutifolium Bark, Himatanthus Sucuuba Bark, Mansoa Alliacea Bark and Leaf, Minquartia Guianenis Bark, Phyllanthus Niruri Whole LIQUID ORAL 20130912 UNAPPROVED HOMEOPATHIC Energique, Inc. BROSIMUM ACUTIFOLIUM BARK; HIMATANTHUS LANCIFOLIUS BARK; MANSOA ALLIACEA BARK; MANSOA ALLIACEA LEAF; MINQUARTIA GUIANENSIS BARK; PHYLLANTHUS NIRURI WHOLE; PIPER ADUNCUM LEAF 32; 32; 32; 32; 32; 32; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0015_0c65f772-20d9-4374-b44d-eae02a83eb62 44911-0015 HUMAN OTC DRUG Allerstat II Baptisia tinctoria, Echinacea, Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Euphrasia officinalis, Natrum sulphuricum, Nux vomica, LIQUID ORAL 20120717 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0016_99829ec8-5685-4893-b418-d3276c6e8cb2 44911-0016 HUMAN OTC DRUG Weed Grass Antigens Allium Cepa, Arsenicum Album, Nux Vomica, Pulsatilla, Alfalfa, Amaranthus, Bamboo, Cocklebur, Dandelion LIQUID ORAL 20120816 UNAPPROVED HOMEOPATHIC Energique, Inc. ONION; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; ALFALFA; AMARANTHUS PALMERI POLLEN; BAMBUSA VULGARIS LEAF; XANTHIUM STRUMARIUM POLLEN; TARAXACUM OFFICINALE WHOLE; SOLIDAGO VIRGAUREA FLOWERING TOP; POA PRATENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANGUSTIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; ARTEMISIA VULGARIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; RED CLOVER; AGROSTIS STOLONIFERA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; ARTEMISIA TRIDENTATA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA PSILOSTACHYA POLLEN; TRIFOLIUM REPENS FLOWER; RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS SPINOSUS POLLEN; IVA ANNUA POLLEN 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0017_a3c53c94-671a-4e06-a02b-b67ccfa16bf2 44911-0017 HUMAN OTC DRUG Household Antigens Acetone, Sodium tripolyphosphate, Propylene glycol, Sodium benzene sulfonate, Sodium lauryl sulfate, Terebinthina, LIQUID ORAL 20120807 UNAPPROVED HOMEOPATHIC Energique, Inc. ACETONE; SODIUM TRIPOLYPHOSPHATE; PROPYLENE GLYCOL; SODIUM BENZENESULFONATE; AMMONIUM CHLORIDE; SODIUM LAURYL SULFATE; TURPENTINE OIL; BUTYL ACETATE; TOLUENE; XYLENE; DIBUTYL PHTHALATE; KEROSENE; SEMECARPUS ANACARDIUM JUICE; GRAPHITE; NITRIC ACID; PULSATILLA VULGARIS; SULFUR; ETHYL ACETATE 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0018_6a261766-2447-4a5c-81a6-bbdc9e6de09f 44911-0018 HUMAN OTC DRUG Asthma HP Arsenicum Album, Belladonna, Blatta Orientalis, Ipecacuanha, Kali Carbonicum, Lobelia Inflata, Natrum Sulphuricum, Silicea LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLATTA ORIENTALIS; IPECAC; POTASSIUM CARBONATE; LOBELIA INFLATA; SODIUM SULFATE; SILICON DIOXIDE; SODIUM SULFATE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0019_b036e05a-0d7b-4cb8-a12c-0a6b819828b7 44911-0019 HUMAN OTC DRUG Adrenapar Aralia Quinoquefolia, Avena Sativa, Glandula Suparenalis Suis, Arsenicum Iodatum, Ignatia Amara, Lycopodium Clavatum, Nux Vomica LIQUID ORAL 20120820 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; ARSENIC TRIIODIDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; ZINC 3; 3; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0020_70aeba1d-8e01-4e4d-a5db-35d300ee95ec 44911-0020 HUMAN OTC DRUG Tree Antigens Conium Maculatum, White Fir, Tulip, Magnolia Sprengeri, Oleander, Lilac, Myrica Cerifera, Acacia Sp., Alder, Ailanthus Glandulosus, Alnus Serrulata, American Beech, American Sycamore, Arizona Ash, Arizona Cottonwood, Arizona Cypress, Austrian Pine, Black Cottonwood, Black Walnut, Black Willow, Blue Beech, Blue Spruce, California Black Oak, California Black Walnut, California Live Oak, Schinus Molle, California Scrub Oak, California White Oak, Celtis Occidentalis, Chinese Elm, Date Palm, Eastern White Pine, LIQUID ORAL 20140506 UNAPPROVED HOMEOPATHIC Energique, Inc. CONIUM MACULATUM FLOWERING TOP; ABIES CONCOLOR POLLEN; LIRIODENDRON TULIPIFERA WHOLE; MAGNOLIA SPRENGERI FLOWER BUD; NERIUM OLEANDER LEAF; SYRINGA VULGARIS FLOWER; MORELLA CERIFERA ROOT BARK; ACACIA SENEGAL FLOWER; ALNUS RUBRA POLLEN; AILANTHUS ALTISSIMA FLOWERING TWIG; ALNUS SERRULATA BARK; FAGUS GRANDIFOLIA POLLEN; PLATANUS OCCIDENTALIS POLLEN; FRAXINUS VELUTINA POLLEN; POPULUS DELTOIDES SUBSP. WISLIZENI POLLEN; CUPRESSUS ARIZONICA POLLEN; PINUS NIGRA POLLEN; POPULUS TRICHOCARPA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; CARPINUS CAROLINIANA POLLEN; PICEA PUNGENS POLLEN; QUERCUS KELLOGGII POLLEN; JUGLANS CALIFORNICA POLLEN; QUERCUS AGRIFOLIA POLLEN; SCHINUS MOLLE POLLEN; QUERCUS DUMOSA POLLEN; QUERCUS LOBATA POLLEN; CELTIS OCCIDENTALIS POLLEN; ULMUS PUMILA POLLEN; PHOENIX DACTYLIFERA POLLEN; PINUS STROBUS POLLEN; EUCALYPTUS GLOBULUS POLLEN; ULMUS CRASSIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; POPULUS FREMONTII POLLEN; BACCHARIS HALIMIFOLIA POLLEN; ACER SACCHARUM POLLEN; PINUS BANKSIANA POLLEN; PINUS THUNBERGII POLLEN; JUGLANS REGIA POLLEN; LIGUSTRUM LUCIDUM POLLEN; PINUS TAEDA POLLEN; PINUS CONTORTA POLLEN; POPULUS NIGRA POLLEN; PROSOPIS JULIFLORA POLLEN; JUNIPERUS ASHEI POLLEN; ACER NEGUNDO POLLEN; OLEA EUROPAEA FLOWER; FRAXINUS LATIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; PINUS SYLVESTRIS POLLEN; PINUS RIGIDA POLLEN; ACER PSEUDOPLATANUS POLLEN; PINUS PONDEROSA POLLEN; POPULUS TREMULOIDES POLLEN; LIGUSTRUM VULGARE POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER RUBRUM POLLEN; MORUS RUBRA POLLEN; PINUS RESINOSA POLLEN; JUNIPERUS SCOPULORUM POLLEN; CARYA OVATA POLLEN; PINUS ECHINATA POLLEN; ACER SACCHARINUM POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; ALNUS RHOMBIFOLIA POLLEN; CARYA TOMENTOSA POLLEN; MORUS ALBA POLLEN; POPULUS ALBA POLLEN; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; ANEMONE PULSATILLA 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0021_2d604973-9905-4613-8ffa-f4a39e772241 44911-0021 HUMAN OTC DRUG Virustat Echinace, Hydrastis Canadensis, Lomatium Dissectum, Aconitum Napellus, Arsenicum Album, Belladonna, Eupatorium Perfoliatum, Gelsemium Sempervirens, LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA, UNSPECIFIED; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; TOXICODENDRON PUBESCENS LEAF; RANCID BEEF 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0022_81b1e41d-9120-4235-a3f6-4a4121e56e82 44911-0022 HUMAN OTC DRUG Multi Flower Aesculus Carnea, Flos, Aesculus Hippocastanum, Flos, Agrimonia Eupatoria, Flos, Bromus Ramosus, Flos, Calluna Vulgaris, Flos, Carpinus Betulus , Flos, Castanea Sativa, Flos, Centaurium Umbellatum, Flos, Ceratostigma Willmottianum, Flos, Cichorium Intybus, Flos, Clematis Vitalba, Flos, Clematis Vitalba, Flos, Fagus Sylvatica, Flos, Gentianella Amarella, Flos, Helianthemum Nummularium, Flos, Ilex Aquifolium, Flos, Impatiens Glandulifera, Flos, Larix Decidua, Flos, Lonicera Caprifolium, Flos LIQUID ORAL 20120824 UNAPPROVED HOMEOPATHIC Energique, Inc. AESCULUS CARNEA FLOWER; AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; BROMUS RAMOSUS FLOWER; CALLUNA VULGARIS FLOWERING TOP; CARPINUS BETULUS FLOWER; CASTANEA SATIVA FLOWER; CENTAURIUM ERYTHRAEA; CERATOSTIGMA WILLMOTTIANUM FLOWER; CICHORIUM INTYBUS FLOWER; CLEMATIS VITALBA FLOWER; FAGUS SYLVATICA FLOWERING TOP; GENTIANELLA AMARELLA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; LARIX DECIDUA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWER; MALUS SYLVESTRIS FLOWER; MIMULUS GUTTATUS FLOWERING TOP; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM; PINUS SYLVESTRIS FLOWERING TOP; POPULUS TREMULA FLOWERING TOP; PRUNUS CERASIFERA FLOWER; QUERCUS ROBUR FLOWER; WATER; ROSA CANINA FLOWER; SALIX ALBA FLOWERING TOP; SCLERANTHUS ANNUUS FLOWERING TOP; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; ULEX EUROPAEUS FLOWER; ULMUS PROCERA FLOWERING TWIG; VERBENA OFFICINALIS FLOWERING TOP; VITIS VINIFERA FLOWERING TOP 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0023_b76cc105-c5bb-40c6-b14d-c30af698762b 44911-0023 HUMAN OTC DRUG BAC HP Apis Mellifica, Arsenicum Album, Belladonna, Chamomilla, Echinacea, Lachesis Mutus, Mercurius Solubilis LIQUID ORAL 20120827 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; ATROPA BELLADONNA; ARSENIC TRIOXIDE; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0024_086446c6-2209-42d5-8b90-fbc6a6bd9f3b 44911-0024 HUMAN OTC DRUG Fungustat I Echinacea, Tabebuia Impetiginosa, Abies Nigra, Lycopodium Clavatum, Nux Vomica, Phosporus, Pulsatilla LIQUID ORAL 20120827 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA, UNSPECIFIED; TABEBUIA IMPETIGINOSA BARK; PICEA MARIANA RESIN; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SKATOLE; CANDIDA ALBICANS 3; 3; 12; 12; 12; 12; 12; 12; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0025_b6d609b6-1aa8-4c08-9472-5c737a56e9a5 44911-0025 HUMAN OTC DRUG Acetylcholine Chloride Phenolic Acetylcholine chloride, LIQUID ORAL 20121108 UNAPPROVED HOMEOPATHIC Energique, Inc. ACETYLCHOLINE CHLORIDE 6 [hp_X]/mL N 20181231 44911-0026_20e9c537-6c01-48d0-a2d1-ab177df2d3d5 44911-0026 HUMAN OTC DRUG Lymphdrainex Geranium robertianum, Nasturtium aquaticum, Aloe socotrina, Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Apis mellifica, Equisetum hyemale, Fumaria officinalis, LIQUID ORAL 20121107 UNAPPROVED HOMEOPATHIC Energique, Inc. GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; ALOE; JUGLANS REGIA LEAF; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; VERONICA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; SMILAX REGELII ROOT; BARIUM CARBONATE; CALCIUM SULFIDE; MERCURIC CYANIDE; FERROUS IODIDE; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; BOS TAURUS PARATHYROID GLAND; SUS SCROFA THYMUS; THYROID, PORCINE 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0027_059da017-7f77-4714-ac17-80706060e18a 44911-0027 HUMAN PRESCRIPTION DRUG Mold Antigens Arsenicum Album, Phosphorus, Pulsatilla, Sepia, Alternaria tenuis, Aspergillus niger, Rhizopus nigricans LIQUID ORAL 20121107 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; RHIZOPUS STOLONIFER; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; SACCHAROMYCES CEREVISIAE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 44911-0028_1fab4ac0-64b1-469d-b4cb-ce64d75e16a0 44911-0028 HUMAN OTC DRUG Bronchitone Echinacea, Lobelia Inflata, Antimonium Tartaricum, Aralia Racemosa, Drosera, Ipecacuanha, Kali Carbonicum LIQUID ORAL 20121107 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; LOBELIA INFLATA; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; DROSERA ROTUNDIFOLIA; IPECAC; POTASSIUM CARBONATE; PHOSPHORUS; SPONGIA OFFICINALIS SKELETON, ROASTED 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0029_ae2c3d42-5392-49e7-bd2e-31a9d7f1ec62 44911-0029 HUMAN OTC DRUG Gastrotone Gentiana lutea, Sambucus nigra, Arsenicum album, Kali bichromicum, Lycopodium clavatum, Phosphorus, Pulsatilla, Bismuthum carbonicum, LIQUID ORAL 20121112 UNAPPROVED HOMEOPATHIC Energique, Inc. GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; ARSENIC TRIOXIDE; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; BISMUTH SUBCARBONATE 3; 3; 12; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0030_422b9ccd-3085-4cef-8921-3e7f5bd82115 44911-0030 HUMAN OTC DRUG ADD HP Gamma-aminobutyric acid, L-dopa, Norepinephrine, Serotonin, Adrenocorticotrophin, Anacardium orientale, Arsenicum album, Baryta carbonica, LIQUID ORAL 20121010 UNAPPROVED HOMEOPATHIC Energique, Inc. .GAMMA.-AMINOBUTYRIC ACID; LEVODOPA; NOREPINEPHRINE; SEROTONIN; CORTICOTROPIN; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; HYOSCYAMUS NIGER; LYCOPODIUM CLAVATUM SPORE; DATURA STRAMONIUM 6; 6; 6; 6; 8; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0031_3911e0db-4f40-43bf-ba97-e410666d9629 44911-0031 HUMAN OTC DRUG Dentastat Allium sativum, Berberis vulgaris, Fucus vesiculosus, Phytolacca decandra, Argentum metallicum, Aurum metallicum, Calcarea fluorica, Calcarea phosphorica, Iodium, Mercurius solubilis, LIQUID ORAL 20121113 UNAPPROVED HOMEOPATHIC Energique, Inc. GARLIC; BERBERIS VULGARIS ROOT BARK; FUCUS VESICULOSUS; PHYTOLACCA AMERICANA ROOT; SILVER; GOLD; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; IODINE; MERCURIUS SOLUBILIS; NICKEL; PLATINUM; SILICON DIOXIDE; ZINC 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0032_a0588cc6-aa3c-4dc3-9544-188bc6bb99df 44911-0032 HUMAN OTC DRUG Weed Grass Antigens Allium cepa, Arsenicum album, Nux vomica, Pulsatilla, Alfalfa, Amaranthus, Bamboo, Cocklebur, Dandelion, Goldenrod, Kentucky blue, Lambs quarter, LIQUID ORAL 20121008 UNAPPROVED HOMEOPATHIC Energique, Inc. ONION; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; ALFALFA; AMARANTHUS HYBRIDUS POLLEN; BAMBUSA VULGARIS LEAF; XANTHIUM STRUMARIUM POLLEN; TARAXACUM OFFICINALE; SOLIDAGO VIRGAUREA FLOWERING TOP; POA PRATENSIS TOP; CHENOPODIUM ALBUM POLLEN; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; FESTUCA PRATENSIS POLLEN; ARTEMISIA VULGARIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; TRIFOLIUM PRATENSE POLLEN; AGROSTIS STOLONIFERA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; ARTEMISIA TRIDENTATA POLLEN; AMARANTHUS SPINOSUS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA PSILOSTACHYA POLLEN; TRIFOLIUM REPENS POLLEN; RUMEX CRISPUS TOP; RUMEX ACETOSA WHOLE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0033_b4716c3f-81c3-49b3-9716-c22a4275e725 44911-0033 HUMAN OTC DRUG Renastat Berberis Vulgaris, Petroselinum Sativum, Sabal Serrulata, Uva Ursi, CAntharis, Lithium Carbonicum, Mercurius Corrosivus LIQUID ORAL 20121004 UNAPPROVED HOMEOPATHIC Energique, Inc. SAW PALMETTO; LYTTA VESICATORIA; LITHIUM CARBONATE; MERCURIC CHLORIDE; BERBERIS VULGARIS ROOT BARK; PETROSELINUM CRISPUM; ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 12; 12; 12; 3; 3; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0034_943bc446-ad67-4781-9e44-8fd95ede5d49 44911-0034 HUMAN OTC DRUG Parastat Artemisia Vulgaris, Cina, Filix Mas, Sabadilla, Spigelia Anthelmia, Baryta Carbonica, Calcarea Carbonica, Sulphur, Terebinthina LIQUID ORAL 20121002 UNAPPROVED HOMEOPATHIC Energique, Inc. ARTEMISIA VULGARIS ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; DRYOPTERIS FILIX-MAS ROOT; SCHOENOCAULON OFFICINALE SEED; SPIGELIA ANTHELMIA; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SULFUR; TURPENTINE OIL 3; 3; 3; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0035_e8613739-38b8-4b60-af6f-388a836d15f3 44911-0035 HUMAN OTC DRUG L Dopa Phenolic L Dopa LIQUID ORAL 20130219 UNAPPROVED HOMEOPATHIC Energique, Inc. LEVODOPA 6 [hp_X]/mL N 20181231 44911-0036_7205250e-a7f3-4b65-a03f-517526103fd7 44911-0036 HUMAN OTC DRUG Sinutone Echinachea, Hydrastis Canadensis, Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Kali Bichromicum, Nux Moschata LIQUID ORAL 20121005 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; ONION; AMBROSIA ARTEMISIIFOLIA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP; ARSENIC TRIOXIDE; POTASSIUM DICHROMATE; NUTMEG 12; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0037_951dd2c7-158c-4102-9382-a88a80aae714 44911-0037 HUMAN OTC DRUG Adrenapar Aralia Quinquefolia, Avena Sativa, Glandula Suprarenalis Suis, Arsenicum Iodatum, Ignatia Amara, Lycopodium Clavatum LIQUID ORAL 20121004 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; ARSENIC TRIIODIDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; ZINC 3; 3; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0038_9b4267d8-899d-41a6-ad61-ab8fdb65be46 44911-0038 HUMAN OTC DRUG Anxiety Aconitum Napellus, Arsenicum Album, Belladonna, Calcarea Carbonica, Carcinosin, Causticum, Gelsemium Sempervirens, Lachesis Mutus, Mercurius Vivus, Nitricum Acidum, Phosphorus, Rhus Tox SPRAY ORAL 20121016 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; ACONITUM NAPELLUS; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; HUMAN BREAST TUMOR CELL; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; MERCURY; NITRIC ACID; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20191231 44911-0039_c6e2c9f0-c204-487b-81a3-ecd654654b83 44911-0039 HUMAN PRESCRIPTION DRUG Liquid B Liquid B Homeopathic, Hordeum Vulgare, Hepar Suis, Heart (Suis), Torula Cerevisiae LIQUID ORAL 20121029 UNAPPROVED HOMEOPATHIC Energique, Inc. HORDEUM VULGARE TOP; PORK LIVER; PORK HEART; SACCHAROMYCES CEREVISIAE 2; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20181231 44911-0042_b386d065-afee-4473-86a5-893190276fd3 44911-0042 HUMAN OTC DRUG Ferrum Phos Ferrum Phosphoricum LIQUID ORAL 20121002 UNAPPROVED HOMEOPATHIC Energique, Inc. FERRUM PHOSPHORICUM 30 [hp_C]/mL N 20181231 44911-0043_56ad774b-9fb0-4d55-bfb4-c1e1145727fd 44911-0043 HUMAN OTC DRUG Diabenex HP Aceticum Acidum, Colchicum Autumnale, Lacticum Acidum, Lycopodium Clavatum, Phosphoricum Acidum, Phosphorus, Syzygium Jambolanum, Uranium Nitricum LIQUID ORAL 20121005 UNAPPROVED HOMEOPATHIC Energique, Inc. ACETIC ACID; COLCHICUM AUTUMNALE BULB; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0044_feb5dff8-087c-4062-a340-005ebf8aa7bd 44911-0044 HUMAN OTC DRUG Anxiety HP Arsenicum album, Calcarea carbonica , Ignatia amara, Kali carbonicum, Lachesis mutus, Natrum muriaticum, Phosphous, Pulsatilla, Staphysagria, LIQUID ORAL 20121015 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0045_dd939ca7-5c61-4703-9c18-2dc8126db127 44911-0045 HUMAN OTC DRUG Terrestristat Alfalfa, Avena Sativa, Fucus Vesiculosus, Thyroidinum, Agate, Cadmium Iodatum, Calcarea Phosphorica LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC Energique, Inc. ALFALFA; AVENA SATIVA TOP; FUCUS VESICULOSUS; THYROID, PORCINE; SILICON DIOXIDE; CADMIUM IODIDE; TRIBASIC CALCIUM PHOSPHATE; COPPER; PHOSPHORIC ACID; PHOSPHORUS; STRONTIUM CARBONATE; CITHARACANTHUS SPINICRUS; URANYL NITRATE HEXAHYDRATE; ALCOHOL, X-RAY EXPOSED (1000 RAD) 3; 3; 3; 6; 3; 12; 12; 12; 12; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 44911-0046_f1cb2c24-dfcb-42a3-a4bc-5f2318ce5ad3 44911-0046 HUMAN OTC DRUG Sinuchron HP Arsenicum album, Hepar sulphuris calcareum, Hydrastis canadensis, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum muriaticum, Phosphorus, Pulsatilla, Sepia Thuja occidentalis, LIQUID ORAL 20121015 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0047_80f6ee71-586e-40de-86c0-04cfb13314da 44911-0047 HUMAN OTC DRUG Progesterone Phenolic Progesterone LIQUID ORAL 20130311 UNAPPROVED HOMEOPATHIC Energique, Inc. PROGESTERONE 6 [hp_X]/mL N 20191231 44911-0048_9eae9a22-a401-4bb0-8f14-0841bf482618 44911-0048 HUMAN PRESCRIPTION DRUG Lyme HP Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Lym D Nosode, Arsenicum Album, Bryonia, Chelidonium Majus LIQUID ORAL 20121129 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; NEISSERIA MENINGITIDIS; JAPANESE ENCEPHALITIS VIRUS; HEPATITIS B VIRUS; BORRELIA BURGDORFERI; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0049_caf6c824-a7a5-4710-a4ec-406c60e4519e 44911-0049 HUMAN PRESCRIPTION DRUG Anpituapar Adrenocorticotrophin, Agnus Castus, Baryta Castus, Baryta Carbonica, Calcarea Carbonica, Iodium, Lac Caninum, Natrum Muriaticum, Phosphoricum Acidum, Sepia, Thyroidinum (Suis) LIQUID ORAL 20121029 20200722 UNAPPROVED HOMEOPATHIC Energique, Inc. CORTICOTROPIN; CHASTE TREE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; CANIS LUPUS FAMILIARIS MILK; SODIUM CHLORIDE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SUS SCROFA THYROID 6; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 44911-0050_f43c3458-2e4d-4a8c-bf93-36798ef9067b 44911-0050 HUMAN PRESCRIPTION DRUG Biting Insect Antigens Cimex lectularius, Formica rufa, Pulex irritans, Vespa crabro, Apis Mellifica, Hypericum Perforatum, Ledum Palustre LIQUID ORAL 20121031 UNAPPROVED HOMEOPATHIC Energique, Inc. CIMEX LECTULARIUS; FORMICA RUFA; PULEX IRRITANS; VESPA CRABRO; APIS MELLIFERA; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG 15; 15; 15; 15; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 44911-0051_50bb8aca-4545-4a40-90c2-c10a82d33cd7 44911-0051 HUMAN OTC DRUG Otoflam HP Belladonna, Conium Maculatum, Dulcamara, Ferrum Phosphoricum, Hepar Sulphuris Calcareum, Kali Bichromicum LIQUID ORAL 20121126 UNAPPROVED HOMEOPATHIC Energique, Inc. ATROPA BELLADONNA WHOLE; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SILICON DIOXIDE; MATRICARIA RECUTITA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 44911-0052_bf4f5364-a843-4cd7-9b63-976d10b755e5 44911-0052 HUMAN OTC DRUG Infect HP Aconitum Napellus, Arsenicum Album, Baptisia Tinctoria, Belladonna, Bryonia, Causticum, Echinacea, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Hydrastis Canadensis, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Lobelia Inflata, Lomatium Dissectum, Lung, Natrum Sulphuricum, Phosphorus, Phytolacca Decandra, Pulsatilla, Pyrogenium, Rhus Tox, Silicea, Sulphur, Symphytum Officinale LIQUID ORAL 20121217 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; CAUSTICUM; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; SUS SCROFA LUNG; SODIUM SULFATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; COMFREY ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0053_f0954931-4ec0-4287-99a7-c3f933245f4b 44911-0053 HUMAN OTC DRUG ALZ HP Anacardium Orientale, Belladonna, Hyoscyamus Niger, Kali Bromatum, Veratrum Album, Baryta Carbonica, Lachesis Mutus LIQUID ORAL 20121116 UNAPPROVED HOMEOPATHIC Energique, Inc. SEMECARPUS ANACARDIUM JUICE; ATROPA BELLADONNA WHOLE; HYOSCYAMUS NIGER; POTASSIUM BROMIDE; VERATRUM ALBUM ROOT; BARIUM CARBONATE; LACHESIS MUTA VENOM; PHOSPHORUS; DATURA STRAMONIUM 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0054_79e15d55-f3ba-4dc3-84fe-6728a928efe5 44911-0054 HUMAN OTC DRUG Bactestat Baptisia Tinctoria, Echinacea, Phytolacca Decandra, Aconitum Napellus, Arsenicum Album, Belladonna, Ferrum Phosphoricum LIQUID ORAL 20121126 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA; ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; PHOSPHORUS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0055_d8142398-6fba-414d-867b-e7d2f005cd2b 44911-0055 HUMAN OTC DRUG Envirostat Berberis Vulgaris, Chelidonium Majus, Lappa Major, Phytolacca Decandra, Calcarea Fluorica, Carbo Animalis, Nux Vomica LIQUID ORAL 20121218 UNAPPROVED HOMEOPATHIC Energique, Inc. BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; CALCIUM FLUORIDE; CARBO ANIMALIS; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SULFUR; THUJA OCCIDENTALIS LEAF 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0056_c327189f-9bfe-4fc5-b958-5004118045c1 44911-0056 HUMAN OTC DRUG Intestipar Gentiana Lutea, Arsenicum Album, Cinchona Officinalis, Colocynthis, Nux Vomica, Phosphorus, Intestinal Mucosa LIQUID ORAL 20121218 20200513 UNAPPROVED HOMEOPATHIC Energique, Inc. GENTIANA LUTEA ROOT; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; BOS TAURUS INTESTINAL MUCOSA 3; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0057_54d7827d-7553-4558-ac48-e283fb58310b 44911-0057 HUMAN OTC DRUG Thyroid HP Baryta Carbonica, Calcarea Carbonica, Calcarea Iodata, Fucus Vesiculosus, Iodium, Natrum Muriaticum, Pulsatilla LIQUID ORAL 20121203 UNAPPROVED HOMEOPATHIC Energique, Inc. BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM IODIDE; FUCUS VESICULOSUS; IODINE; SODIUM CHLORIDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0058_c3b547d6-7af2-4871-9e01-a7fa7559027b 44911-0058 HUMAN OTC DRUG Thyrostat Fucus Vesiculosus, Spongia Tosta, Pituitaria Glandula, Thyroidinum, Arsenicum Iodatum, Baryta Carbonica LIQUID ORAL 20121203 UNAPPROVED HOMEOPATHIC Energique, Inc. FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; ARSENIC TRIIODIDE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE 3; 3; 6; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0059_ab3b2d4d-c79a-4b19-bb67-626f61d6ddea 44911-0059 HUMAN OTC DRUG Rescue 5 Cherry Plum, Clematis, Impatiens, Rock Rose, Star of Bethlehem LIQUID ORAL 20130326 UNAPPROVED HOMEOPATHIC Energique, Inc. PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; ORNITHOGALUM UMBELLATUM 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0060_4a4409de-094b-463e-9153-ff63fd95094f 44911-0060 HUMAN OTC DRUG HZ HP Lycopodicum Clavatum, Mezereum, Natrum Muriaticum, Nitricum Acidum, Ranunculus Bulbosus, Rhus Tox, Sepia, Thuja Occidentalis LIQUID ORAL 20121219 UNAPPROVED HOMEOPATHIC Energique, Inc. LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; NITRIC ACID; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0061_7ecb2d33-2dd9-4f76-ae0d-d89f72c1baef 44911-0061 HUMAN OTC DRUG Rescue 5 Cherry Plum, Clematis, Impatiens, Rose Rose, Star of Bethlehem LIQUID ORAL 20121227 UNAPPROVED HOMEOPATHIC Energique, Inc. PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; ORNITHOGALUM UMBELLATUM 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 44911-0062_1c93b52b-03ca-4109-9de6-aac07a9c026e 44911-0062 HUMAN OTC DRUG Hepapar Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Chenopodium Anthelminticum, Hepar Suis, Lycopodium Clavatum LIQUID ORAL 20130104 UNAPPROVED HOMEOPATHIC Energique, Inc. SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; TARAXACUM OFFICINALE; DYSPHANIA AMBROSIOIDES; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 3; 3; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0063_628d9ac9-ed78-4ec3-9fe9-cc5245bc9c0b 44911-0063 HUMAN OTC DRUG Lymphapar Echinacea, Phytolacca Decandra, Lymph Node, Conium Maculatum, Ferrum Iodatum, Hepar Sulphuris Calcareum , Ferrum Iodatum LIQUID ORAL 20130103 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; SUS SCROFA LYMPH; CONIUM MACULATUM FLOWERING TOP; FERROUS IODIDE; CALCIUM SULFIDE; POTASSIUM CHLORIDE; LACHESIS MUTA VENOM; SILICON DIOXIDE 3; 3; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0064_e17abc2b-d9f8-4843-abca-05157c24e757 44911-0064 HUMAN OTC DRUG Traumatone Calendula Officinalis, Symphytum Officinale, Arnica Montana, Bellis Perennis, Hypericum Perforatum, Ledum Palustre, Phosphorus, Rhus Tox, Ruta Graveolens, Staphysagria, Strontium Carbonicum LIQUID ORAL 20130219 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; STRONTIUM CARBONATE 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0065_9a8a273b-b5fe-4883-a54a-163b6cb0d379 44911-0065 HUMAN OTC DRUG Virustat Echinacea, Hydrastis Canadensis, Lomatium Dissectum, Aconitum Napellus, Arsenicum Album, Belladonna LIQUID ORAL 20120219 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; TOXICODENDRON PUBESCENS LEAF; RANCID BEEF 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0066_fe38c973-9ac4-450c-a240-b647014f5326 44911-0066 HUMAN OTC DRUG Infectistat Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Lobelia Inflata, Lomatium Dissectum, Phytolacca Decandra LIQUID ORAL 20130102 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; SUS SCROFA LUNG; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; RANCID BEEF 3; 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0067_a51a42c5-104c-40f7-bf55-ac4ebc011c2e 44911-0067 HUMAN OTC DRUG Bone Repair HP Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Hekla Lava, Hydrofluoricum Acidum, Magnesia Phosphorica, Rhus Tox, Ruta Graveolens, Silicea, Symphytum Officinale LIQUID ORAL 20130220 UNAPPROVED HOMEOPATHIC Energique, Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; HEKLA LAVA; HYDROFLUORIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; COMFREY ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0068_2c1bcddf-a86f-45be-80c4-b8b3c0cbd95d 44911-0068 HUMAN OTC DRUG Allerpoll HP Allium Cepa, Ambrosia Artemisiaefolia, Apis Mellfica, Arsenic Album, Euphrasia Officinalis, Nux Vomica, Phosphorus, Pulsatilla LIQUID ORAL 20130912 UNAPPROVED HOMEOPATHIC Energique, Inc. ONION; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0069_c83bf209-7eae-4122-b2d9-867079d42fb1 44911-0069 HUMAN OTC DRUG Hypothalmupar Aralia Quinquefolia, Ginkgo Biloba, Hydrocotyle Asiatica, Brain, Hypothalamus, Pituitaria Glandula, Phosphorus, Silicea LIQUID ORAL 20130102 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; GINKGO; CENTELLA ASIATICA; PORK BRAIN; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; PHOSPHORUS; SILICON DIOXIDE 3; 3; 3; 6; 6; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0070_47e7ca59-62af-4f9c-962a-cd8bfe3a6c2d 44911-0070 HUMAN OTC DRUG Hepastat Beta Vulgaris, Carduus Marianus, Taraxacum Officinale, Cholesterinum, Fel Tauri, Chelidonium Majus, Lycopodium Clavatum LIQUID ORAL 20130411 UNAPPROVED HOMEOPATHIC Energique, Inc. BETA VULGARIS; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE; CHOLESTEROL; BOS TAURUS BILE; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 3; 3; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0071_a5efb6af-cd6b-4eaf-9700-bc82767b1665 44911-0071 HUMAN OTC DRUG Headache HP Belladonna, Bryonia, Gelsemium Sempervirens, Glonoinum, Melilotus Officinalis, Natrum Muriaticum LIQUID ORAL 20130306 UNAPPROVED HOMEOPATHIC Energique, Inc. ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; MELILOTUS OFFICINALIS TOP; SODIUM CHLORIDE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0072_b2c487fa-1cbd-4f4e-b078-7a72ea8fde68 44911-0072 HUMAN OTC DRUG Allerstat II Baptisia Tinctoria, Echinacea, Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Euphrasia Officinalis LIQUID ORAL 20130326 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0073_d3577e77-37f7-48cd-8cbb-068d58ef89cf 44911-0073 HUMAN OTC DRUG Gastropanpar Pancreas, Stomach, Arsenicum Album, Graphites, Lycopodium Clavatum, Nuv Vomica, Phosphorus, Syzygium Jambolanum LIQUID ORAL 20130325 UNAPPROVED HOMEOPATHIC Energique, Inc. SUS SCROFA PANCREAS; SUS SCROFA STOMACH; ARSENIC TRIOXIDE; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SYZYGIUM CUMINI SEED 6; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0074_fa8e82c9-f049-48fe-a905-3543f1850457 44911-0074 HUMAN OTC DRUG Nausea Vomitting HP Aethusa Cynapium, Arsenicum Album, Cocculus Indicus, Ipecacuanha, Kreosotum, Petroleum, Pulsatilla LIQUID ORAL 20130326 UNAPPROVED HOMEOPATHIC Energique, Inc. AETHUSA CYNAPIUM; ARSENIC TRIOXIDE; ANAMIRTA COCCULUS SEED; IPECAC; WOOD CREOSOTE; PETROLATUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; TOBACCO LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0075_5b166a19-d1fa-4713-9fe6-3a1c65b7f300 44911-0075 HUMAN OTC DRUG Pancreapar Hydrastis Canadensis, Syzygium Jambolanum, Glandula Suprarenalis Suis, Pancreas Suis, Pituitary, Phaseolus LIQUID ORAL 20130411 UNAPPROVED HOMEOPATHIC Energique, Inc. GOLDENSEAL; SYZYGIUM CUMINI SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PANCREAS; SUS SCROFA PITUITARY GLAND; KIDNEY BEAN; ACETIC ACID; LACTIC ACID; PHOSPHORIC ACID; PHOSPHORUS; URANYL NITRATE HEXAHYDRATE 3; 3; 6; 6; 6; 9; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0076_055c78a4-0a50-4a2e-b6ed-f8e4b50eeb34 44911-0076 HUMAN OTC DRUG Lymphdrainex Geeranium Robertianum, Nasturtium Aquaticum, Aloe Socotrina, Juglans Regia, Myosotis Arvensis, Scrophularia Nodosa LIQUID ORAL 20130411 UNAPPROVED HOMEOPATHIC Energique, Inc. GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; ALOE; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; VERONICA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; SARSAPARILLA; BARIUM CARBONATE; CALCIUM SULFIDE; MERCURIC CYANIDE; FERROUS IODIDE; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; BOS TAURUS PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID 3; 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0077_b482318f-1479-4642-a343-64c39c489783 44911-0077 HUMAN OTC DRUG Relaxatone Passiflora Incarnata, Scutellaria Lateriflora, Valeriana Officinalis, Arsenicum Album, Calcarea Carbonica, Coffea Cruda LIQUID ORAL 20130412 UNAPPROVED HOMEOPATHIC Energique, Inc. PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA; VALERIAN; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; LYCOPUS VIRGINICUS; DELPHINIUM STAPHISAGRIA SEED 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0078_b521ec49-c754-4777-b9eb-b23c720aecdd 44911-0078 HUMAN OTC DRUG Tinnitus HP Ginkgo Biloba, Chininum Sulphuricum, Cinchona Officinalis, Graphites, Natrum Salicylicum, Plumbum Metallicum LIQUID ORAL 20130412 UNAPPROVED HOMEOPATHIC Energique, Inc. GINKGO; QUININE SULFATE; CINCHONA OFFICINALIS BARK; GRAPHITE; SODIUM SALICYLATE; LEAD; SALICYLIC ACID; SPIGELIA ANTHELMIA; ALLYLTHIOUREA 6; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0079_9b2ba9c2-dac9-4bc5-9047-8a0f0eda5b18 44911-0079 HUMAN OTC DRUG PMS Tone Angelica Archangelica, Cimicifuga Racemosa, Fucus Vesiculosus, Cuprum Metallicum, Lac Caninum, Lachesis Mutus LIQUID ORAL 20130501 UNAPPROVED HOMEOPATHIC Energique, Inc. ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; FUCUS VESICULOSUS; COPPER; CANIS LUPUS FAMILIARIS MILK; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0080_25d80027-9574-451b-94bd-fe05d6a060dd 44911-0080 HUMAN OTC DRUG Flutone Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Phytolacca Decandra, Arsenicum Album, Bryonia, Eupatorium Perfoliatum LIQUID ORAL 20130423 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0081_cac60922-de0d-4771-8c2d-bf401ee7ac79 44911-0081 HUMAN OTC DRUG Anas Barbariae Anas Barbariae LIQUID ORAL 20130425 UNAPPROVED HOMEOPATHIC Energique, Inc. CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/mL N 20181231 44911-0082_666b1c54-e2bd-4e56-ba5e-747e3277ba37 44911-0082 HUMAN OTC DRUG Thymupar Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Thymus, Arsenicum Album, Belladonna, Hepar Sulphuris Calcareum LIQUID ORAL 20130501 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; SUS SCROFA THYMUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; CALCIUM SULFIDE; IRIDIUM; LACHESIS MUTA VENOM 3; 3; 3; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0083_9725d1d8-9bec-4771-a617-1f8bae387fcc 44911-0083 HUMAN OTC DRUG Infectistat Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Lobelia Inflata, Lomatium Dissectum, Phytolacca Decandra, Symphytum Officinale, Lung (Suis), Aconitum napellus, Arsenicum Album, Belladonna, Bryonia, Causticum, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Natrum Sulphuricum, Phosphorus, Pulsatilla, Rhus Toxicodendron, Silicea, Sulphur, Pyrogenium LIQUID ORAL 20130501 20201103 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; SUS SCROFA LUNG; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; RANCID BEEF 3; 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0084_4ffffcb8-7022-4176-969e-06cd1c901ff7 44911-0084 HUMAN OTC DRUG Thyropar Fucus Vesiculosus, Spongia Tosta, Glandula Suprarenalis Suis, Hypophysis Suis, Thyroidinum (Suis), Bromium, Calcarea Carbonica, Iodium, Lachesis Mutus, Pulsatilla (Vulgaris) LIQUID ORAL 20130501 UNAPPROVED HOMEOPATHIC Energique, Inc. FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; LACHESIS MUTA VENOM; PULSATILLA VULGARIS 3; 3; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0085_042ea8e9-dd30-4670-97e5-c50b7d4a207a 44911-0085 HUMAN OTC DRUG Thyropar Fucus Vesiculosus, Spongia Tosta, Glandula Suprarenalis Suis, Hypophysis Suis, Bromium, Calcarea Carbonica, Iodium, Lachesis Mutus, Pulsatilla (Vulgaris) LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC Energique, Inc. FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; LACHESIS MUTA VENOM; PULSATILLA VULGARIS 3; 3; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0086_1a5c077d-d2f7-41d0-81e2-24fd88317949 44911-0086 HUMAN OTC DRUG Cystotone Sarsaparilla, Uva-Ursi, Arsenicum Album, Cantharis, Pareira Brava, Pulsatilla, Sepia, Terebinthina, Populus Tremuloides LIQUID ORAL 20130815 UNAPPROVED HOMEOPATHIC Energique, Inc. SARSAPARILLA; ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CHONDRODENDRON TOMENTOSUM ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; TURPENTINE OIL; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF 3; 3; 12; 12; 12; 12; 12; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0087_470d850e-e251-4510-af25-a19f8b95491b 44911-0087 HUMAN OTC DRUG Terrestristat Alfalfa, Avena Sativa, Fucus Vesiculosus, Thyroidinum (Suis), Agate, Cadmium Iodatum, Calcarea Phosphorica, Cuprum Metallicum LIQUID ORAL 20130912 UNAPPROVED HOMEOPATHIC Energique, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; FUCUS VESICULOSUS; SUS SCROFA THYROID; SILICON DIOXIDE; CADMIUM IODIDE; TRIBASIC CALCIUM PHOSPHATE; COPPER; PHOSPHORIC ACID; PHOSPHORUS; STRONTIUM CARBONATE; CITHARACANTHUS SPINICRUS; URANYL NITRATE HEXAHYDRATE; ALCOHOL, X-RAY EXPOSED (1000 RAD) 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0088_80ae9e33-716f-43aa-9111-32f445e43096 44911-0088 HUMAN OTC DRUG TSH CORD Thyroid Stimulating Hormone (Bovine) LIQUID ORAL 20130815 UNAPPROVED HOMEOPATHIC Energique, Inc. THYROTROPIN 6 [hp_X]/mL N 20181231 44911-0089_6867cf9b-ab24-4065-b1e8-8c2a9f32f5db 44911-0089 HUMAN OTC DRUG Cold HP Aconitum Napellus, Allium Cepa, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Kali Bichromicum, LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; ONION; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0090_840cd3af-880b-43c0-9ff6-98a616404cb5 44911-0090 HUMAN OTC DRUG Star of Bethlehem 30C Star of Bethlehem LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC Energique, Inc. ORNITHOGALUM UMBELLATUM 30 [hp_C]/mL N 20181231 44911-0091_51ad43b2-7f2f-48c2-83e6-62ba5302af71 44911-0091 HUMAN OTC DRUG Grain and Seed Antigens Bamboo, Barley, Corn, Levant Cotton, Flax, Millet, Milo, Oat, California Poppy, Rice, Rye, Safflower, Sesame, Sorghum, Soy Bean, Sugarcane LIQUID ORAL 20130918 UNAPPROVED HOMEOPATHIC Energique, Inc. LOPHATHERUM GRACILE LEAF; BARLEY; CORN; LEVANT COTTON SEED; FLAX SEED; MILLET; SORGHUM BICOLOR WHOLE; OAT; ESCHSCHOLZIA CALIFORNICA; BROWN RICE; RYE; SAFFLOWER; SESAME SEED; SORGHUM; SOYBEAN; SUGARCANE; SUNFLOWER SEED; WHEAT; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0093_3750f867-636f-44c1-8606-3b4842d09f5c 44911-0093 HUMAN OTC DRUG Oak 30C Quercus Robur LIQUID ORAL 20140616 UNAPPROVED HOMEOPATHIC Energique, Inc. QUERCUS ROBUR FLOWER 30 [hp_C]/mL N 20181231 44911-0094_8c17b039-ba3c-49a0-a49f-da19c8f4c0da 44911-0094 HUMAN OTC DRUG Endopar M Aralia racemosa, Sabal serrulata, Glandula suprarenalis suis, Orchitinum suis, Pituitaria glandula suis, Prostrate suis, Agnus castus, LIQUID ORAL 20131030 UNAPPROVED HOMEOPATHIC Energique, Inc. ARALIA RACEMOSA ROOT; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; SUS SCROFA TESTICLE; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; CHASTE TREE; CLEMATIS RECTA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; THUJA OCCIDENTALIS LEAF 3; 3; 6; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0095_5e06ae1b-6a9f-485d-a8b9-c454eea3ae05 44911-0095 HUMAN OTC DRUG Thyroxine Cord Thyroxine LIQUID ORAL 20140110 20180618 UNAPPROVED HOMEOPATHIC Energique, Inc. LEVOTHYROXINE 8 [hp_X]/mL N 20181231 44911-0096_e9bd6bd4-509a-4e84-8ffc-f1830cf05dc6 44911-0096 HUMAN PRESCRIPTION DRUG Recovatone Glycyrrhiza glabra, Kali muriaticum, Magnesia muriatica, Zincum gluconicum, Kali phosphoricum, Natrum muriaticum, Iodium Phosphorus, Adrenalinum, LIQUID ORAL 20130709 UNAPPROVED HOMEOPATHIC Energique, Inc. GLYCYRRHIZA GLABRA; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; ZINC GLUCONATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; IODINE; PHOSPHORUS; EPINEPHRINE; CORTICOTROPIN; ASCORBIC ACID; CALCIUM GLUCONATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; CREATINE; FERROUS GLUCONATE; GLUTAMINE; ARGININE; LEVOCARNITINE; LEUCINE; ORNITHINE; VALINE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; POTASSIUM GLUCONATE; CHROMIUM; MOLYBDENUM; NICKEL; SELENIUM DIOXIDE; SELENIUM; STRONTIUM CARBONATE; VANADIUM; TRIBASIC CALCIUM PHOSPHATE; BORON 1; 2; 2; 2; 3; 3; 4; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient],Carnitine [Chemical/Ingredient],Carnitine Analog [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 44911-0097_fde517ab-34b1-407d-b8aa-fcd65b8d1607 44911-0097 HUMAN PRESCRIPTION DRUG Psorinum Psorinum LIQUID ORAL 20141209 UNAPPROVED HOMEOPATHIC Energique, Inc. SCABIES LESION LYSATE (HUMAN) 7 [hp_X]/mL N 20181231 44911-0098_eff08e5a-3455-492b-88b7-4d9aeb574c35 44911-0098 HUMAN OTC DRUG Vascular HP Aesculus hippocastanum, Collinsonia canadensis, Echinacea, Hamamelis virginiana, Pulsatilla (Vulgaris), Arnica montana, Carbo vegetabilis, Graphittes, LIQUID ORAL 20140224 UNAPPROVED HOMEOPATHIC Energique, Inc. HORSE CHESTNUT; COLLINSONIA CANADENSIS ROOT; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PULSATILLA VULGARIS; ARNICA MONTANA; ACTIVATED CHARCOAL; GRAPHITE; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS WHOLE; SEPIA OFFICINALIS JUICE 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0099_b2f99cb9-0b4c-4ef8-95cd-63cf2db11b2b 44911-0099 HUMAN OTC DRUG ADD HP Gaba, L-Dopa, Norepinephrine, Serotonin, Adrenocorticotrophin, Anacardium Orientale, Arsenicum Album, Baryta Carbonica, Calcarea Carbonica, Calcarea Phosphorica, Hyoscyamus Niger, Lycopodium Clavatum LIQUID ORAL 20140710 UNAPPROVED HOMEOPATHIC Engergique, Inc. .GAMMA.-AMINOBUTYRIC ACID; LEVODOPA; NOREPINEPHRINE; SEROTONIN HYDROCHLORIDE; CORTICOTROPIN; ANACARDIUM OCCIDENTALE FRUIT; ARSENIC TRIOXIDE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; HYOSCYAMUS NIGER; LYCOPODIUM CLAVATUM SPORE; DATURA STRAMONIUM 6; 6; 6; 6; 8; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0100_94ffdad8-9b58-4016-86c6-5952ac5972c3 44911-0100 HUMAN OTC DRUG PARASITE DETOX NOT APPLICABLE LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Energique, Inc. DRYOPTERIS FILIX-MAS ROOT; PUNICA GRANATUM ROOT BARK; FRANGULA PURSHIANA BARK; JUGLANS REGIA LEAF; WORMWOOD; HORSE CHESTNUT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ARTEMISIA CINA PRE-FLOWERING TOP; COPPER; IPECAC; LYCOPODIUM CLAVATUM SPORE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; KRAMERIA LAPPACEA ROOT; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SANTONIN; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TEUCRIUM MARUM 3; 3; 3; 5; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0101_b8735e23-433c-4025-a1c0-656463830f81 44911-0101 HUMAN OTC DRUG Lymphdrainex Geranium robertianum, Nasturtium aquaticum, Aloe socotrina, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Apis mellifica, Equisteum hyemale, LIQUID ORAL 20140527 UNAPPROVED HOMEOPATHIC Energique, Inc. GERANIUM ROBERTIANUM; NASTURTIUM AQUATICUM; ALOE; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; VERONICA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; SARSAPARILLA; BARIUM CARBONATE; CALCIUM SULFIDE; MERCURIC CYANIDE; FERROUS IODIDE; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; BOS TAURUS PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 5; 5; 5; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0102_0e8bbea7-37ce-431b-9114-3f05a60ed8fc 44911-0102 HUMAN PRESCRIPTION DRUG LYMPHDRAINEX Geranium Robertianum, Nasturtium Aquaticum, Aloe Socotrina, Mysotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia LIQUID ORAL 20130808 UNAPPROVED HOMEOPATHIC Energique, Inc. GERANIUM ROBERTIANUM; NASTURTIUM AQUATICUM; ALOE; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; VERONICA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; JUGLANS REGIA LEAF; SARSAPARILLA; BARIUM CARBONATE; CALCIUM SULFIDE; MERCURIC CYANIDE; FERROUS IODIDE; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; PARATHYROID HORMONE; SUS SCROFA THYMUS; SUS SCROFA THYROID 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 5; 5; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Parathyroid Hormone [Chemical/Ingredient],Parathyroid Hormone [EPC] N 20181231 44911-0103_61c6d4af-5f18-4126-81f5-6a59cb3848c6 44911-0103 HUMAN OTC DRUG Cherry Plum PRUNUS CERASIFERA, FLOS LIQUID ORAL 20141218 UNAPPROVED HOMEOPATHIC Energique, Inc. PRUNUS CERASIFERA FLOWER 30 [hp_C]/mL N 20181231 44911-0107_4d98f87c-7207-4297-8b24-3c6cfee138b2 44911-0107 HUMAN OTC DRUG Candique Candida Albicans LIQUID ORAL 20131115 UNAPPROVED HOMEOPATHIC Energique, Inc. CANDIDA ALBICANS 30 [hp_C]/mL N 20181231 44911-0108_9f69b1ef-5d2a-4887-9980-416b1db57780 44911-0108 HUMAN OTC DRUG FUNGUSTAT I Echinacea (Angustifolia), Tabebuia Impetiginosa, Abies Nigra, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris), Sepia, Skatolum, Candida Albicans LIQUID ORAL 20150105 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; TABEBUIA IMPETIGINOSA BARK; PICEA MARIANA RESIN; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SKATOLE; CANDIDA ALBICANS 3; 3; 12; 12; 12; 12; 12; 12; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0109_af5c4b65-7f9c-417d-add1-dde5e55c73a1 44911-0109 HUMAN OTC DRUG WINTER BLEND Echinacea (Angustifolia), Uva-Ursi, Baptisia Tinctoria, Convallaria Majalis, Kali Muriaticum, Pinus Sylvestris, Thuja Occidentalis, Bryonia, Crotalus Horridus, Lachesis Mutus, Selenium Metallicum, Viscum Album LIQUID ORAL 20141002 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; ARCTOSTAPHYLOS UVA-URSI LEAF; BAPTISIA TINCTORIA ROOT; CONVALLARIA MAJALIS; POTASSIUM CHLORIDE; PINUS SYLVESTRIS LEAFY TWIG; THUJA OCCIDENTALIS LEAFY TWIG; BRYONIA ALBA ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; LACHESIS MUTA VENOM; SELENIUM; VISCUM ALBUM FRUITING TOP 1; 1; 3; 6; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0110_19d8ba48-e574-418a-bb22-5da219bfc10a 44911-0110 HUMAN OTC DRUG Body Balance Avena Sativa, Chlorophytum Borivilianum, Nuphar Luteum, Punica Granatum, Spermidine, Spermine, Damiana, Selenium Metallicum, Staphysagria, Thuja Occidentalis LIQUID ORAL 20131202 UNAPPROVED HOMEOPATHIC Energique, Inc. AVENA SATIVA FLOWERING TOP; ASPARAGUS ADSCENDENS ROOT; NUPHAR LUTEUM ROOT; POMEGRANATE; SPERMIDINE; SPERMINE; TURNERA DIFFUSA LEAFY TWIG; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAF 3; 3; 6; 6; 6; 6; 9; 9; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0111_175aef77-002f-4b99-8d59-df1551d3f1b1 44911-0111 HUMAN OTC DRUG Allerstat II Baptisia tinctoria, Echinacea (angustifolia), Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Euphrasia officinalis, Natrum sulphuricum, LIQUID ORAL 20140317 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0112_aa2bc633-758f-4eb7-ada9-6a210725e9d8 44911-0112 HUMAN OTC DRUG ALLERSTAT II NOT APPLICABLE LIQUID ORAL 20141015 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0113_7f01c1cc-09a2-4745-bd83-1b5891335200 44911-0113 HUMAN OTC DRUG LYME HP NOT APPLICABLE LIQUID ORAL 20141028 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; BORRELIA BURGDORFERI; JAPANESE ENCEPHALITIS VIRUS; HEPATITIS B VIRUS; NEISSERIA MENINGITIDIS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0114_df942a2d-16a4-4dee-a082-2d77234a5f82 44911-0114 HUMAN OTC DRUG LYME HP NOT APPLICABLE LIQUID ORAL 20141020 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; BORRELIA BURGDORFERI; JAPANESE ENCEPHALITIS VIRUS; HEPATITIS B VIRUS; NEISSERIA MENINGITIDIS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0115_a73817c0-4ea2-465c-aa4e-e7e18214ac69 44911-0115 HUMAN OTC DRUG Terrestristat Alfalfa, Avena sativa, Fucus vesiculosus, Thyroidinum (suis), Agate, Cadmium iodatum, Calcarea phosphorica, Cuprum metallicum, Phosphoricum acidum, LIQUID ORAL 20140516 UNAPPROVED HOMEOPATHIC Energique, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; FUCUS VESICULOSUS; SUS SCROFA THYROID; SILICON DIOXIDE; CADMIUM IODIDE; TRIBASIC CALCIUM PHOSPHATE; COPPER; PHOSPHORIC ACID; PHOSPHORUS; STRONTIUM CARBONATE; CITHARACANTHUS SPINICRUS; URANYL NITRATE HEXAHYDRATE; ALCOHOL, X-RAY EXPOSED (1000 RAD) 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0116_493897dd-2151-4c5c-b06e-d4a63f83b805 44911-0116 HUMAN OTC DRUG Bactestat Baptisia tinctoria, Echinacea (angustifolia), Phytolacca decandra, Aconitum napellus, Arsenicum album, Belladonna, Ferrum phosphoricum LIQUID ORAL 20140324 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; PHOSPHORUS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0117_8ea403e8-2583-4d38-ae74-a36b999d5201 44911-0117 HUMAN OTC DRUG Virustat Echinacea (Angustifolia), Hydrastis canadensis, Lomatium dissectum, Aconitum napellus, Arsenicum album, Belladonna, Eupatorium perfoliatum, Gelsemium sempervirens, Lachesis mutus, Rhus tox, Pyrogenium, LIQUID ORAL 20140424 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; ACONITUM NAPELLUS; ARSENIC ACID; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; TOXICODENDRON PUBESCENS LEAF; RANCID BEEF 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0118_d9d1914c-ce7c-433e-9f7b-aea5a4ef5f58 44911-0118 HUMAN OTC DRUG Terrestristat Alfalfa, Avena sativa, Fucus vesiculosus, Thyroidinum (suis), Agate, Cadmium iodatum, Calcarea phosphorica, Cuprum metallicum, LIQUID ORAL 20140516 UNAPPROVED HOMEOPATHIC Energique, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; FUCUS VESICULOSUS; SUS SCROFA THYROID; SILICON DIOXIDE; CADMIUM IODIDE; TRIBASIC CALCIUM PHOSPHATE; COPPER; PHOSPHORIC ACID; PHOSPHORUS; STRONTIUM CARBONATE; CITHARACANTHUS SPINICRUS; URANYL NITRATE HEXAHYDRATE; ALCOHOL, X-RAY EXPOSED (1000 RAD) 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0119_55a638e0-98c8-4065-a22d-729a64abb0f9 44911-0119 HUMAN OTC DRUG Fungustat I Echinacea (Angustifolia), Tabebuia impetiginosa, Abies nigra, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla (Vulgaris), Sepia, Skatolum, Canadida albicans, LIQUID ORAL 20140505 UNAPPROVED HOMEOPATHIC Energique, Inc ECHINACEA ANGUSTIFOLIA; TABEBUIA IMPETIGINOSA BARK; PICEA MARIANA RESIN; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SKATOLE; CANDIDA ALBICANS 3; 3; 12; 12; 12; 12; 12; 12; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0120_f9e378d6-b689-4685-ae48-3225990f0f64 44911-0120 HUMAN OTC DRUG Lymphdrainex Geranium Robertianum, Nasturtium Aquaticum, Aloe Socotrina, Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Apis Mellifica, Equisetum Hyemale, Fumaria Officinalis, Natrum Sulphuricum, Phytolacca Decandra, Pinus Sylvestris, Veronica Officinalis, Gentiana Lutea, Juglans Regia, Sarsaparilla (Smilax Regelii) Baryta Carbonica, Hepar Sulphuris Calcareum, Mercurius Cyanatus, Ferrum Iodatum, Aranea Diadema, Calcarea Phosphorica, Parathyroid Gland (Bovine), Thymus (Suis), Thyroidinum (Suis) LIQUID ORAL 20140527 UNAPPROVED HOMEOPATHIC Energique, Inc. GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; ALOE; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; VERONICA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; SMILAX REGELII ROOT; BARIUM CARBONATE; CALCIUM SULFIDE; MERCURIC CYANIDE; FERROUS IODIDE; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; BOS TAURUS PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 5; 5; 5; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0121_1a8b2baf-f0a6-4d36-9c2d-b7067d826c68 44911-0121 HUMAN OTC DRUG Candida Cord Candida Albicans LIQUID ORAL 20140708 UNAPPROVED HOMEOPATHIC Energique, Inc. CANDIDA ALBICANS 12 [hp_X]/mL N 20181231 44911-0122_d73175c8-fb71-45f6-b58d-490645f60c2b 44911-0122 HUMAN OTC DRUG BAC HP NOT APPLICABLE LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0123_2df325c5-281e-49f0-9d42-52fdf0eb1d1f 44911-0123 HUMAN OTC DRUG BAC HP Apis mellifica, Arsenicum album, Belladonna, Chamomilla, Echinacea (Angustifolia), Lachesis mutus, Mercurius solubilis, Pulsatilla (Vulgaris), Pyrogenium, Rhus tox, Silicea, LIQUID ORAL 20141211 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0124_376042fd-89d6-48c6-8b85-69a700705722 44911-0124 HUMAN OTC DRUG Trauma plus Gel not applicable GEL TOPICAL 20140718 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; HYPERICUM PERFORATUM; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; SULFURIC ACID; CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE 1; 1; 1; 3; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g N 20181231 44911-0125_bba3235b-103c-4731-87f4-05dade29f2a3 44911-0125 HUMAN OTC DRUG Virustat Echinacea (Angustifolia), Hydrastis Canadensis, Lomatium Dissectum, Aconitum Napellus, Arsenicum Album, Belladonna, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lachesis Mutus, Rhus Tox Pyrogenium LIQUID ORAL 20140902 20210623 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; TOXICODENDRON PUBESCENS LEAF; RANCID BEEF 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0126_317b0ea8-2040-488c-8423-a393694a59f0 44911-0126 HUMAN OTC DRUG Male Balance NOT APPLICABLE LIQUID ORAL 20140915 UNAPPROVED HOMEOPATHIC Energique,Inc. (Larry Krenk) AVENA SATIVA FLOWERING TOP; PORK LIVER; SUS SCROFA TESTICLE; TESTOSTERONE; CHASTE TREE; TURNERA DIFFUSA LEAFY TWIG; GINKGO; SUS SCROFA HYPOTHALAMUS; LYCOPODIUM CLAVATUM SPORE; SPERMIDINE; SPERMINE; SOMATROPIN; EPIMEDIUM GRANDIFLORUM TOP; SEROTONIN HYDROCHLORIDE 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 26; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0127_dd554b5f-2ec8-43b7-8be9-21a68518adf3 44911-0127 HUMAN OTC DRUG TRAUMA PLUS NOT APPLICABLE GEL TOPICAL 20140926 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; HYPERICUM PERFORATUM; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; SULFURIC ACID; CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE 1; 1; 1; 3; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g N 20181231 44911-0130_28b0ffa1-f680-41f4-bd26-598cd31217aa 44911-0130 HUMAN OTC DRUG WART BARYTA CARBONICA, ANTIMONIUM CRUDUM, CAUSTICUM, DULCAMARA, NITRICUM ACIDUM, SILICEA, STAPHYSAGRIA, THUJA OCCIDENTALIS, CALCAREA CARBONICA, SEPIA GEL TOPICAL 20141203 UNAPPROVED HOMEOPATHIC Engergique, Inc. BARIUM CARBONATE; ANTIMONY TRISULFIDE; CAUSTICUM; SOLANUM DULCAMARA TOP; NITRIC ACID; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE 12; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_C]/g N 20181231 44911-0131_cce9bcc5-4187-46be-a048-35e49bf2694b 44911-0131 HUMAN OTC DRUG INFECTISTAT BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOBELIA INFLATA, LOMATIUM DISSECTUM, PHYTOLACCA DECANDRA LIQUID ORAL 20141205 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; SUS SCROFA LUNG; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; RANCID BEEF 3; 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 1; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0132_5a4c0cb2-032e-4673-b552-e761eac49815 44911-0132 HUMAN OTC DRUG MUSCLE/TENDON PAIN AND STRESS RELIEF Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20141230 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0133_b2552801-9c5b-4f4a-9c78-85f9b605de97 44911-0133 HUMAN OTC DRUG Joint Pain and Stiffness Relief Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (similax regelii) SPRAY TOPICAL 20150107 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0134_aa8a35b9-c5e9-4608-9599-fa1a170cec18 44911-0134 HUMAN OTC DRUG Headache Pain and Sinus Pressure Relief Calendula officinalis, Croton Tiglium, Natum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20141231 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0135_69398d56-cd32-4345-ae1c-cfde825b67f2 44911-0135 HUMAN OTC DRUG First Aid Pain and Trauma Relief Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20121230 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0136_ed4ede4c-00ec-46df-b3a2-9573eed11876 44911-0136 HUMAN OTC DRUG Skin Irritant and Healing Support Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (similax regelii) SPRAY TOPICAL 20140107 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0137_93b58835-1c14-4616-898c-dbc37bbcd543 44911-0137 HUMAN OTC DRUG SHINGLES PAIN ULCERATION RELIEF Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20150105 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0138_140f49ce-5cbb-4724-b786-8e40dd71d27e 44911-0138 HUMAN OTC DRUG TRAUMA PLUS Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum, Calcarea Fluorica, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Natrum Sulphuricum GEL TOPICAL 20150113 20201029 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; HYPERICUM PERFORATUM; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; SULFURIC ACID; CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE 1; 1; 1; 3; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g N 20181231 44911-0139_a796181d-5f11-4c78-9b55-56e56449a511 44911-0139 HUMAN OTC DRUG Arthritis Gel Colchicum Autumnale, Propolis, Kalmia Latifolia, Bronia (Alba), Causticum, Kali Carbonicum, Ledum Palustre, Rhododendron Chrysanthum, Rhus Tox, Thuja Occidentalis GEL TOPICAL 20150202 UNAPPROVED HOMEOPATHIC Energique, Inc. COLCHICUM AUTUMNALE BULB; PROPOLIS WAX; KALMIA LATIFOLIA LEAF; BRYONIA ALBA ROOT; CAUSTICUM; POTASSIUM CARBONATE; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 44911-0140_f532b5df-40cc-4ee5-90e7-d73c6a653a2a 44911-0140 HUMAN OTC DRUG VASCULAR HP Aesculus Hippocastanum, Collinsonia Canadensis, Echinacea (Angustifolia), Hamamelis Virginiana, Pulsatilla (Vulgaris), Arnica Montana, Carbo Vegetabilis, Graphites, Hydrofluoricum Acidum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Paeonia Officinalis, Sepia LIQUID ORAL 20150130 UNAPPROVED HOMEOPATHIC Energique, Inc. HORSE CHESTNUT; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PULSATILLA VULGARIS; ARNICA MONTANA; ACTIVATED CHARCOAL; GRAPHITE; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; SEPIA OFFICINALIS JUICE 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0141_181a4baf-339a-4989-b22d-2b8271120d2b 44911-0141 HUMAN OTC DRUG Ivy Relief Gel Impatiens Glandulifera, Flos, Arnica Montana, Croton Tiglium, Graphites, Grindelia, Sanguinaria Canadensis, Urtica Urens, Xerophyllum Asphdeloides, Anacardium Orientale, Mezereum, Rhus Tox GEL TOPICAL 20150407 UNAPPROVED HOMEOPATHIC Energique, Inc. IMPATIENS GLANDULIFERA FLOWER; ARNICA MONTANA; CROTON TIGLIUM SEED; GRAPHITE; GRINDELIA HIRSUTULA FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; URTICA URENS; XEROPHYLLUM ASPHODELOIDES; SEMECARPUS ANACARDIUM JUICE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF 2; 2; 12; 12; 12; 12; 12; 12; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 44911-0142_9468cb53-f25a-4f34-a293-be835c824f1c 44911-0142 HUMAN OTC DRUG Cort Sym Apis Mellifica, Belladonna, Calcarea Carbonica, Mezereum, Rhus Tox, Astacus Fluviatilis, Gelsemium Sempervirens GEL TOPICAL 20150402 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; ASTACUS ASTACUS; GELSEMIUM SEMPERVIRENS ROOT 12; 12; 12; 12; 12; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 44911-0143_9532f14a-c9ad-4bc9-8fdc-3330aab193fd 44911-0143 HUMAN OTC DRUG Serotonin Phenolic Serotonin (Hydrochloride) LIQUID ORAL 20150427 UNAPPROVED HOMEOPATHIC Energique, Inc. SEROTONIN HYDROCHLORIDE 4 [hp_X]/mL N 20181231 44911-0144_fd40572c-db80-443c-88e8-a60f3367c615 44911-0144 HUMAN OTC DRUG Ignatia Ignatia Amara LIQUID ORAL 20150508 UNAPPROVED HOMEOPATHIC Energique, Inc. STRYCHNOS IGNATII SEED 200 [hp_C]/mL N 20181231 44911-0145_ee0b7f47-ed49-40f5-9e96-c0fcca713f68 44911-0145 HUMAN OTC DRUG Ars Alb Arsenicum Album LIQUID ORAL 20150511 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE 200 [hp_C]/mL N 20181231 44911-0146_855120f9-f43d-43dc-b4fc-a6b685915c67 44911-0146 HUMAN OTC DRUG Ars Alb Arsenicum Album LIQUID ORAL 20150512 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE 30 [hp_C]/mL N 20181231 44911-0147_d995e555-2223-41bb-a0f1-d41e58d40d68 44911-0147 HUMAN OTC DRUG Lithium Carb Lithium Carbicum LIQUID ORAL 20150512 UNAPPROVED HOMEOPATHIC Energique, Inc. LITHIUM CARBONATE 12 [hp_X]/mL N 20181231 44911-0148_606b14c0-22eb-4eed-a796-e29ae0e5c3dd 44911-0148 HUMAN OTC DRUG EBV Stat Astragalus Membranaceus, Echinacea (Angustifolia), Hydrastis Canadensis, Phytolacca Decandra, Aranea Diadema, Iridium Metallicum, Lycopodium Clavatum, Rhus Tox, Silicea, Sepia LIQUID ORAL 20150706 UNAPPROVED HOMEOPATHIC Energique, Inc. ASTRAGALUS PROPINQUUS ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; ARANEUS DIADEMATUS; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SEPIA OFFICINALIS JUICE 3; 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0149_c0897539-ab33-46dd-8d07-d20a9039e9f7 44911-0149 HUMAN OTC DRUG Scarstat Calendula Officinalis, Graphites, Hypericum Perforatum, Silicea, Staphysagria, Thiosinaminum LIQUID ORAL 20150512 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; HYPERICUM PERFORATUM; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; ALLYLTHIOUREA 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0150_61667fa3-4cc1-42a4-8685-0074e0537ed3 44911-0150 HUMAN OTC DRUG Colostat Hydrastis Canadensis, Rhamnus Purshiana, Spigelia Anthelmia, Taraxacum Officinale, Cajuputum, Alumina, Cina, Cinchona Officinalis, Lycopodium Clavatum, Magnesia Phosphorica, Mandragora Officinarum, Nux Vomica LIQUID ORAL 20150512 20200520 UNAPPROVED HOMEOPATHIC Energique, Inc. GOLDENSEAL; FRANGULA PURSHIANA BARK; SPIGELIA ANTHELMIA; TARAXACUM OFFICINALE; CAJUPUT OIL; ALUMINUM OXIDE; ARTEMISIA CINA PRE-FLOWERING TOP; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANDRAGORA OFFICINARUM ROOT; STRYCHNOS NUX-VOMICA SEED 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0151_9804afb0-a8b6-4f64-b9ab-72f8da61553e 44911-0151 HUMAN OTC DRUG Parathyropar Symphytum Officinale, Calcarea Carbonica, Silicea, Calcarea Phosphorica, Manganum Metallicum, Baryta Carbonica, Hekla Lava, Rhus Tox, Parathormonum LIQUID ORAL 20150512 20200625 UNAPPROVED HOMEOPATHIC Energique, Inc. COMFREY ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE; MANGANESE; BARIUM CARBONATE; HEKLA LAVA; TOXICODENDRON PUBESCENS LEAF; PARATHYROID HORMONE 3; 12; 12; 12; 12; 12; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 44911-0152_9788ac4b-7443-4846-822c-9f09da9bb31d 44911-0152 HUMAN OTC DRUG Aconite Aconitum Napellus LIQUID ORAL 20150514 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS 30 [hp_C]/mL N 20181231 44911-0153_0effbb74-da9e-42b0-9562-21085c73298c 44911-0153 HUMAN OTC DRUG Enuresis HP Argentum Nitricum, Belladonna, Causticum, Equisetum Hyemale, Ferrum Phosphoricum, Kreosotum, Nitricum Acidum, Pulsatilla (Pratensis), Thuja Occidentalis, Thyroidinum (Suis) LIQUID ORAL 20150514 UNAPPROVED HOMEOPATHIC Energique, Inc. SILVER NITRATE; ATROPA BELLADONNA; CAUSTICUM; EQUISETUM HYEMALE; FERROSOFERRIC PHOSPHATE; WOOD CREOSOTE; NITRIC ACID; PULSATILLA PRATENSIS; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, PORCINE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0154_943196ce-682b-4c05-9254-e7cf51ea96d2 44911-0154 HUMAN OTC DRUG Drainpar Propolis, Solidago Virgaurea, Trifolium Pratense, Hepar (Suis), Kidney (Suis), Lymph Node (Suis), Berberis Vulgaris, Bryonia (Alba), Ceanothus Americanus, Chelidonium Majus, Nux Vomica LIQUID ORAL 20150514 UNAPPROVED HOMEOPATHIC Energique, Inc. PROPOLIS WAX; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIFOLIUM PRATENSE FLOWER; PORK LIVER; PORK KIDNEY; SUS SCROFA LYMPH; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; STRYCHNOS NUX-VOMICA SEED 2; 2; 2; 6; 6; 6; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0155_80b597fb-7f23-4a88-a36a-10532feb40c2 44911-0155 HUMAN OTC DRUG Phosphorus Phosphorus LIQUID ORAL 20150514 UNAPPROVED HOMEOPATHIC Energique, Inc. PHOSPHORUS 30 [hp_C]/mL N 20181231 44911-0156_3e26b7ec-729c-4b23-8c50-b7360cfbed97 44911-0156 HUMAN OTC DRUG Thuja Thuja Occidentalis LIQUID ORAL 20150514 UNAPPROVED HOMEOPATHIC Energique, Inc. THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_C]/mL N 20181231 44911-0157_2b8e9733-69be-486e-b4a7-1aee39eb6b3d 44911-0157 HUMAN OTC DRUG Cystoges HP Berberis Vulgaris, Cantharis, Clematis Erecta, Equisetum Hyemale, Lac Caninum, Lycopodium Clavatum, Pulsatilla (Pratensis), Sarsaparilla (Smilax Regelii), Sepia, Staphysagria LIQUID ORAL 20150519 UNAPPROVED HOMEOPATHIC Energique, Inc. BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; CLEMATIS RECTA FLOWERING TOP; EQUISETUM HYEMALE; CANIS LUPUS FAMILIARIS MILK; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PRATENSIS; SMILAX REGELII ROOT; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0158_a15cfb57-1c66-49d7-ae50-42ffd79a8e0b 44911-0158 HUMAN OTC DRUG Pre/Post Surgetone Hypericum Perforatum, Symphytum Officinale, Arnica Montana LIQUID ORAL 20150519 UNAPPROVED HOMEOPATHIC Energique, Inc. HYPERICUM PERFORATUM; COMFREY ROOT; ARNICA MONTANA 12; 12; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0159_5fa7c949-d090-41c8-8579-58d451f2c447 44911-0159 HUMAN OTC DRUG Nat Mur Natrum Muriaticum LIQUID ORAL 20150519 UNAPPROVED HOMEOPATHIC Energique, Inc. SODIUM CHLORIDE 30 [hp_C]/mL N 20181231 44911-0160_40e05ee1-f672-4cab-9594-7b84be49e84c 44911-0160 HUMAN OTC DRUG Multi-Cell Salt Kali Muriaticum, Kali Phosphoricum, Kali Sulphuricum, Natrum Muriaticum, Natrum Phosphoricum, Natrum Sulphuricum, Calcarea Sulphurica, Calcarea Fluorica, Calcarea Phosphorica, Ferrum Phosphoricum, Magnesia Phosphorica, Silicea LIQUID ORAL 20150615 UNAPPROVED HOMEOPATHIC Energique, Inc. POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; CALCIUM SULFATE ANHYDROUS; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE 3; 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0161_99769e74-5225-4684-a150-5e44dccaa077 44911-0161 HUMAN OTC DRUG Elm Ulmus Procera, Flos LIQUID ORAL 20150519 UNAPPROVED HOMEOPATHIC Energique, Inc. ULMUS PROCERA FLOWERING TWIG 30 [hp_C]/mL N 20181231 44911-0162_852e8205-9bd2-45b6-840d-1c4c2c7d84f1 44911-0162 HUMAN OTC DRUG Dermapar Epithelia (Bovine), Arsenicum Album, Calcarea Carbonica, Graphites, Mezereum, Natrum Muriaticum, Nitricum Acidum, Petroleum, Rhus Tox, Sulphur, Causticum LIQUID ORAL 20150706 UNAPPROVED HOMEOPATHIC Energique, Inc. BOS TAURUS SKIN; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; NITRIC ACID; KEROSENE; TOXICODENDRON PUBESCENS LEAF; SULFUR; CAUSTICUM 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0163_d25e7b24-1b8a-4254-b9d7-a130236a6ac9 44911-0163 HUMAN OTC DRUG Allertone Allium Sativum, Baptisia Tinctoria, Echinacea (Angustifolia), Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Phosphorus, Pulsatilla (Pratensis), Solidago Virgaurea LIQUID ORAL 20150519 UNAPPROVED HOMEOPATHIC Energique, Inc. GARLIC; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA PRATENSIS; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0164_052cbd85-4eef-499d-aa20-37374797415d 44911-0164 HUMAN OTC DRUG Dairy Antigens American Cheese, Blue Cheese, Brie Cheese, Cheddar Cheese, Cottage Cheese, Goat Milk, Lac Vaccinum, Swiss Cheese, Calcarea Carbonica, Sepia, Sulphur LIQUID ORAL 20150706 UNAPPROVED HOMEOPATHIC Energique, Inc. WHEY; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED; GOAT MILK; COW MILK; CASEIN, EMMENTAL CULTURED; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0165_c7970b2e-7a5d-414c-a0a2-d78e1b136838 44911-0165 HUMAN OTC DRUG LYME HP Baptisia tinctoria, Echinacea (angustifolia), Hydrastis canadensis, Borrelia burgdorferi nosode, Encephalitis nosode, Meningococcus nosode, Hepatitis B nosode, Arsenicum album, Bryonia (alba), Chelidonium majus, Colchicum autumnale, Kalmia latifolia, Ledum palustre, Lycopodium clavatum, Phosphorus, Rhus tox LIQUID ORAL 20150715 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; BORRELIA BURGDORFERI; JAPANESE ENCEPHALITIS VIRUS; NEISSERIA MENINGITIDIS; HEPATITIS B VIRUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 12; 12; 15; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0166_5bad3342-0bb4-4c96-a62d-46cefbd8c76e 44911-0166 HUMAN OTC DRUG Kali Mur Kali Muriaticum LIQUID ORAL 20150520 UNAPPROVED HOMEOPATHIC Energique, Inc. POTASSIUM CHLORIDE 200 [hp_C]/mL N 20181231 44911-0167_1f90a966-b8a7-44a5-ad0b-0199cf139208 44911-0167 HUMAN OTC DRUG Rescue 5 Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos LIQUID ORAL 20150616 20200617 UNAPPROVED HOMEOPATHIC Energique, Inc. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0169_24803f37-ae4c-4b2c-90ec-06b1059cf809 44911-0169 HUMAN OTC DRUG Pneumo HP Ammonium Muriaticum, Antimonium Tartaricum, Arsenicum Album, Bryonia (Alba), Calcarea Carbonica, Lobelia Inflata, Natrum Sulphuricum, Phosphorus, Spongia Tosta LIQUID ORAL 20150617 UNAPPROVED HOMEOPATHIC Energique, Inc. AMMONIUM CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LOBELIA INFLATA; SODIUM SULFATE; PHOSPHORUS; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0170_3c957d25-ae5a-4568-8850-109751e08f76 44911-0170 HUMAN OTC DRUG Nux Vom Nux Vomica LIQUID ORAL 20150617 UNAPPROVED HOMEOPATHIC Energique, Inc. STRYCHNOS NUX-VOMICA SEED 200 [hp_C]/mL N 20181231 44911-0171_2ec9dcf3-c13e-48b5-9223-e947bc8ab9bc 44911-0171 HUMAN OTC DRUG Salmonella Salmonella Typhi LIQUID ORAL 20150617 UNAPPROVED HOMEOPATHIC Energique, Inc. SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI 200 [hp_C]/mL N 20181231 44911-0172_f5b29bb0-8c27-449d-9543-ded029c672b6 44911-0172 HUMAN OTC DRUG Thyroid Homeopathic Capsicum Annuum, Thyroidinum (Suis), Ferrum Metallicum, Baryta Carbonica, Iodium, Pulsatilla (Vulgaris) LIQUID ORAL 20150618 UNAPPROVED HOMEOPATHIC Energique, Inc. CAPSICUM; THYROID, PORCINE; IRON; BARIUM CARBONATE; IODINE; PULSATILLA VULGARIS 6; 6; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0173_e355b1af-9351-4501-afff-87f40b860b3a 44911-0173 HUMAN OTC DRUG Aspergillus Niger Aspergillus Niger LIQUID ORAL 20150707 UNAPPROVED HOMEOPATHIC Energique, Inc. ASPERGILLUS NIGER VAR. NIGER 30 [hp_C]/mL N 20181231 44911-0174_7b6fe461-7f6f-4890-8494-c6a2ecd9d837 44911-0174 HUMAN OTC DRUG Rheumatism HP Bryonia (Alba), Colchicum Autumnale, Formica Rufa, Kalmia Latifolia, Ledum Palustre, Lycopodium Clavatum , Rhododendron Chrysanthum, Rhus Tox LIQUID ORAL 20150707 UNAPPROVED HOMEOPATHIC Energique, Inc. BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; FORMICA RUFA; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0175_8a22e483-7d00-4acf-aed7-35a991c31c40 44911-0175 HUMAN OTC DRUG Phosphorus Phosphorus LIQUID ORAL 20150707 UNAPPROVED HOMEOPATHIC Energique, Inc. PHOSPHORUS 200 [hp_C]/mL N 20191231 44911-0176_48534cf7-030e-4182-85df-32e24dca3b0b 44911-0176 HUMAN OTC DRUG Zinc Met Zincum metallicum LIQUID ORAL 20150708 UNAPPROVED HOMEOPATHIC Energique, Inc. ZINC 30 [hp_X]/mL N 20181231 44911-0177_82d101f6-983a-4c8c-b739-4ca0ab2d3ac6 44911-0177 HUMAN OTC DRUG Rhus Tox Rhus Tox LIQUID ORAL 20150708 UNAPPROVED HOMEOPATHIC Energique, Inc. TOXICODENDRON PUBESCENS LEAF 200 [hp_C]/mL N 20181231 44911-0178_d7f39310-7a39-47ac-bbf2-fe8b88918f6c 44911-0178 HUMAN OTC DRUG Allerstat I Chelidonium majus, Echinacea (Angustifolia), Gentiana lutea, Arsenicum album, Carbo vegetabilis, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla (Pratensis) LIQUID ORAL 20150708 UNAPPROVED HOMEOPATHIC Energique, Inc. CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GENTIANA LUTEA ROOT; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA PRATENSIS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0179_78332235-3b2c-4166-98ce-3d46dcac6a8e 44911-0179 HUMAN OTC DRUG Acetaldehyde Phenolic Acetaldehyde LIQUID ORAL 20150708 UNAPPROVED HOMEOPATHIC Energique, Inc. ACETALDEHYDE 6 [hp_X]/mL N 20181231 44911-0180_544bc1d5-b642-4420-9481-2e2c2877b8b0 44911-0180 HUMAN OTC DRUG Cancordistat Mercurius Solubilis, Candida Albicans LIQUID ORAL 20150708 UNAPPROVED HOMEOPATHIC Energique, Inc. MERCURIUS SOLUBILIS; CANDIDA ALBICANS 12; 12 [hp_X]/mL; [hp_X]/mL N 20181231 44911-0181_e8a14f87-6425-4fc3-9ed4-39c5708e864a 44911-0181 HUMAN OTC DRUG Vertitone Baptisia Tinctoria, Agaricus Muscarius, Arsenicum Album, Belladonna, Calcarea Carbonica, Cocculus Indicus, Conium Maculatum, Phosphorus, Pulsatilla (Pratensis) LIQUID ORAL 20150708 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; AMANITA MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; PHOSPHORUS; PULSATILLA PRATENSIS 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0182_015ce68e-18f6-4883-aad5-363d11879e0a 44911-0182 HUMAN OTC DRUG Alcostat Beta vulgaris, Taraxacum officinale, Trifolium pratense, Capsicum annuum, Chelidonium majus, Lycopodium clavatum, Nox vomica, Quercus glandium spiritus, Sulphuricum acidum, Ethylicum, Saccharum officinale, LIQUID ORAL 20150708 UNAPPROVED HOMEOPATHIC Energique, Inc. BETA VULGARIS; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; CAPSICUM; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; QUERCUS ROBUR NUT; SULFURIC ACID; ALCOHOL; SUCROSE 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0183_c8fca88c-5fce-4cab-bf4f-bf9feb508bb7 44911-0183 HUMAN OTC DRUG SILICEA Silicea LIQUID ORAL 20150708 UNAPPROVED HOMEOPATHIC Energique, Inc. SILICON DIOXIDE 200 [hp_C]/mL N 20181231 44911-0184_af4d9aa6-a820-40bc-9ca7-d9a1674c7cc3 44911-0184 HUMAN OTC DRUG CARDIO TONIC Cactus grandiflorus, L-carnitine, Strophanthus hispidus, Borago officinalis, Linum usitatissimum, Heart (suis), Kali carbonicum, Kali nitricum, Thyroidinum (suis), Adonis vernalis, Digitalis purpurea, Lycopus virginicus, LIQUID ORAL 20150708 20200724 UNAPPROVED HOMEOPATHIC Energique, Inc. SELENICEREUS GRANDIFLORUS STEM; LEVOCARNITINE; STROPHANTHUS HISPIDUS SEED; BORAGE; FLAX SEED; PORK HEART; POTASSIUM CARBONATE; POTASSIUM NITRATE; SUS SCROFA THYROID; ADONIS VERNALIS; DIGITALIS; LYCOPUS VIRGINICUS 3; 3; 3; 4; 4; 6; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0185_1eb2ff22-d401-4df7-a997-dd661777903d 44911-0185 HUMAN OTC DRUG Nat Phos Natrum Phosphoricum LIQUID ORAL 20150708 UNAPPROVED HOMEOPATHIC Energique, Inc. SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 200 [hp_C]/mL N 20181231 44911-0186_ab845fde-6044-495c-85e4-14682953d51c 44911-0186 HUMAN OTC DRUG Silicea Silicea LIQUID ORAL 20150708 UNAPPROVED HOMEOPATHIC Energique, Inc. SILICON DIOXIDE 30 [hp_C]/mL N 20181231 44911-0187_b769a083-9a20-49e1-848d-0e85768e5087 44911-0187 HUMAN OTC DRUG Dizziness HP Calcarea carbonica, Chenopodium anthelminticum, Cocculus indicus, Conium maculatum, Nux vomica, Phosphorus, Pulsatilla (pratensis), Silicea, Tabacum, LIQUID ORAL 20150708 UNAPPROVED HOMEOPATHIC Energique, Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA PRATENSIS; SILICON DIOXIDE; TOBACCO LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0188_8482cb2a-e8ce-433b-983b-42232d8c3702 44911-0188 HUMAN OTC DRUG Adrenal Homeopathic Capsicum Annuum, Glandula Suprarenalis Suis, Ferrum Metallicum, Ammonium Muriaticum, Kali Carbonicum, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20150723 UNAPPROVED HOMEOPATHIC Energique, Inc. CAPSICUM; SUS SCROFA ADRENAL GLAND; IRON; AMMONIUM CHLORIDE; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 6; 6; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0189_bc42f5e8-7993-49b0-b1ba-ec58b9710ae9 44911-0189 HUMAN OTC DRUG H. Pylori Helicobacter Pylori LIQUID ORAL 20150708 UNAPPROVED HOMEOPATHIC Energique, Inc. HELICOBACTER PYLORI 12 1/mL N 20181231 44911-0190_e04a24d5-d026-4aac-9b37-b00f41712ef6 44911-0190 HUMAN OTC DRUG Glutathione Glutathione, LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. GLUTATHIONE 5 [hp_X]/mL N 20181231 44911-0191_00a3ca4d-a739-411c-b0a7-5eccd2d1934e 44911-0191 HUMAN OTC DRUG CARCINOSIN CORD Carcinosin LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC Energique, Inc. HUMAN BREAST TUMOR CELL 12 [hp_X]/mL N 20181231 44911-0192_99539864-7f0b-4edd-aad9-b3c8d0fc56eb 44911-0192 HUMAN OTC DRUG Fungustat II Echinacea (angustifolia), Fucus vesiculosus, Hydrastis canadensis, Phytolacca decandra, Kreosotum, Natrum muriaticum, Candida albicans, Lycopodium clavatum, Pulsatilla (pratensis), Sepia, LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. ECHINACEA ANGUSTIFOLIA; FUCUS VESICULOSUS; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; WOOD CREOSOTE; SODIUM CHLORIDE; CANDIDA ALBICANS; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PRATENSIS; SEPIA OFFICINALIS JUICE 3; 3; 3; 6; 12; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0193_26aaedbb-a574-4793-a88c-7fb02fbc2639 44911-0193 HUMAN OTC DRUG Mastitis HP Belladonna, Bryonia (Alba), Hepar Sulphuris Calcareum, Mercurius Solubilis, Phytolacca Decandra, Pulsatilla (Pratensis), Silicea LIQUID ORAL 20150714 UNAPPROVED HOMEOPATHIC Energique, Inc. ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; PULSATILLA PRATENSIS; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0194_5a8d2f34-370a-4a73-90a4-2dfbb16d948e 44911-0194 HUMAN OTC DRUG MELATONIN CORD Melatonin LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC Energique, Inc. MELATONIN 6 [hp_C]/mL N 20181231 44911-0195_f6524a0b-0b30-4d99-bbcf-ef034a77e6db 44911-0195 HUMAN OTC DRUG DOPAMINE PHENOLIC Dopamine hydrochloride LIQUID ORAL 20150714 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. DOPAMINE HYDROCHLORIDE 6 [hp_X]/mL N 20181231 44911-0196_53ac933a-890b-4b63-a6b1-b34c550c534e 44911-0196 HUMAN OTC DRUG CV HP Adonis vernalis, Lachesis mutus, Lycopus virginicus, Valeriana officinalis, Aurum metallicum, Cactus grandiflorus, Digitalis purpurea, Natrum muriaticum, Phosphorus, Pulsatilla (pratensis), LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. ADONIS VERNALIS; LACHESIS MUTA VENOM; LYCOPUS VIRGINICUS; VALERIAN; GOLD; SELENICEREUS GRANDIFLORUS STEM; DIGITALIS; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA PRATENSIS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0197_66b7341f-e359-407d-95d6-45ab1c5c2f97 44911-0197 HUMAN OTC DRUG HYPERT HP Arnica montana, Aurum metallicum, Cactus grandiflorus, Calcarea carbonica, Lachesis mutus, Natrum muriaticum, Nux vomica, Phosphorus, Solidago virgaurea, LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. ARNICA MONTANA; GOLD; SELENICEREUS GRANDIFLORUS STEM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LACHESIS MUTA VENOM; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SOLIDAGO CANADENSIS FLOWERING TOP 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0198_d32dd610-8ac4-4051-83f3-efdd422cb844 44911-0198 HUMAN OTC DRUG CMV STAT Echnacea (angustifolia), Hydrastis canadensis, Lomatium dissectum, Phytolacca decandra, Tabebuia impetiginosa, Aranea diadema, Ipecacuanha, Iridium metallicum, Lachesis mutus, Muriaticum acidum, Rhox tox, Epstein-barr virus nosode, LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; PHYTOLACCA AMERICANA ROOT; TABEBUIA IMPETIGINOSA BARK; ARANEUS DIADEMATUS; IPECAC; IRIDIUM; LACHESIS MUTA VENOM; HYDROCHLORIC ACID; TOXICODENDRON PUBESCENS LEAF; HUMAN HERPESVIRUS 4 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0199_d2ee17c6-e59a-40f8-8bd6-383549cd909f 44911-0199 HUMAN OTC DRUG ESTROGEN PHENOLIC Estradiol, LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. ESTRADIOL 6 [hp_X]/mL N 20181231 44911-0200_ee5174c0-83b6-415f-800f-99037fc49b80 44911-0200 HUMAN OTC DRUG PMS HP Belladonna, Kali Carbonicum, Lachesis Mutus, Magnesia Phosphorica, Natrum Muriaticum, Nux Vomica, Pulsatilla (Pratensis), Sepia LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC Energique, Inc. ATROPA BELLADONNA; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA PRATENSIS; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0201_61474eea-743e-481b-b379-517e4ff5214b 44911-0201 HUMAN OTC DRUG PREGNENOLONE Pregnenolone LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC Energique, Inc. PREGNENOLONE 30 [hp_C]/mL N 20181231 44911-0202_7a926809-3668-496c-b56f-2302fc7bbcf7 44911-0202 HUMAN OTC DRUG Serotonin Phenolic Serotonin LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC Energique, Inc. SEROTONIN HYDROCHLORIDE 4 [hp_X]/mL N 20181231 44911-0203_3468720a-601a-469e-b3a3-510831ac9f0a 44911-0203 HUMAN OTC DRUG HZ STAT Astragalus membranaceus, Echinacea (angustifolia), Hydrastis canadensis, Hypericum perforatum, Dulcamara, Gelsemium sempervirens, Nitricum acidum, Ranunculus bulbosus, Thuja occidentalis LIQUID ORAL 20150714 20210524 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. ASTRAGALUS PROPINQUUS ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HYPERICUM PERFORATUM; SOLANUM DULCAMARA TOP; GELSEMIUM SEMPERVIRENS ROOT; NITRIC ACID; RANUNCULUS BULBOSUS; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0204_34530f24-e698-46e9-bd8c-2dc78a950bdb 44911-0204 HUMAN OTC DRUG FUNGUSTAT II Echinacea (angustifolia), Fucus vesiculosus, Hydrastis canadensis, Phytolacca decandra, Kreosotum, Natrum muriaticum, Candida albicans, Lycopodium clavatum, Pulsatilla (Pratensis), Sepia LIQUID ORAL 20150714 20200814 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. ECHINACEA ANGUSTIFOLIA; FUCUS VESICULOSUS; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; WOOD CREOSOTE; SODIUM CHLORIDE; CANDIDA ALBICANS; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PRATENSIS; SEPIA OFFICINALIS JUICE 3; 3; 3; 6; 12; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0205_4d378946-c7db-4340-83b7-30397694e238 44911-0205 HUMAN OTC DRUG Histamine Phenolic Histaminum Hydrochloricum LIQUID ORAL 20150727 UNAPPROVED HOMEOPATHIC Energique, Inc. HISTAMINE DIHYDROCHLORIDE 6 [hp_X]/mL N 20181231 44911-0206_ac385484-8092-4bd5-b491-fa5f6262a58d 44911-0206 HUMAN OTC DRUG Calc Phos Calcarea Phosphorica LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC Energique, Inc. TRIBASIC CALCIUM PHOSPHATE 200 [hp_C]/mL N 20181231 44911-0207_3909c45a-0eb0-4878-84f9-4777deed2216 44911-0207 HUMAN OTC DRUG CALC PHOS Calcarea Phosphorica LIQUID ORAL 20150709 UNAPPROVED HOMEOPATHIC Energique, Inc. TRIBASIC CALCIUM PHOSPHATE 30 [hp_C]/mL N 20181231 44911-0208_ef923f83-438d-4d49-9673-7bbb3bfe485e 44911-0208 HUMAN OTC DRUG FERRUM PHOS Ferrum Phosphoricum LIQUID ORAL 20150710 UNAPPROVED HOMEOPATHIC Energique, Inc. FERROSOFERRIC PHOSPHATE 200 [hp_C]/mL N 20181231 44911-0209_4a193c72-8451-405b-94ef-ba2b65558350 44911-0209 HUMAN OTC DRUG ACONITE Aconitum napellus LIQUID ORAL 20150715 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. ACONITUM NAPELLUS 200 [hp_C]/mL N 20181231 44911-0210_472536a1-4662-4c9d-a937-6c7b9ff10c02 44911-0210 HUMAN OTC DRUG PSORIASIS HP Arsenicum iodatum, Borax, Graphites, Lycopodium clavatum, Natrum muriaticum, Petroleum, Sepia, Sulphur LIQUID ORAL 20150715 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. ARSENIC TRIIODIDE; SODIUM BORATE; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; KEROSENE; SEPIA OFFICINALIS JUICE; SULFUR 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0211_6961d67a-b358-4cc9-8aca-ec0e99e1dfda 44911-0211 HUMAN OTC DRUG Ototone Baptisia Tinctoria, Echinacea Angustifolia, Hydrastis Canadensis, Phytolacca Decandra, Belladonna, Calcarea Carbonica, Chamomilla, Ferrum Phosphoricum, Mercurius Solubilis, Pulsatilla (Pratensis) LIQUID ORAL 20150810 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; MERCURIUS SOLUBILIS; PULSATILLA PRATENSIS 3; 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0212_1dd2cb43-381b-4b4f-8b63-3f6004c60c4d 44911-0212 HUMAN OTC DRUG PARATHYROID CORD Parathyroid gland (suis) LIQUID ORAL 20150716 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. SUS SCROFA PARATHYROID GLAND 12 [hp_X]/mL N 20181231 44911-0213_b26576c4-8ab8-42aa-805d-cc6b2ed68d15 44911-0213 HUMAN OTC DRUG LIGAPAR Lappa major, Arnica montana, Bryonia (alba), Calcarea phosphorica, Causticum, Rhododendron chrysanthum, Rhus tox, Ruta graveolens, Silicea, Zincum metallicum, Ligament (human) LIQUID ORAL 20150715 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. ARCTIUM LAPPA ROOT; ARNICA MONTANA; BRYONIA ALBA ROOT; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; ZINC; HUMAN LIGAMENT 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 44911-0214_65a0c434-bed0-44ef-aeba-a213f07a8e9f 44911-0214 HUMAN OTC DRUG E-COLI Colibacillinum cum natrum muriaticum LIQUID ORAL 20150715 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. ESCHERICHIA COLI 30 [hp_C]/mL N 20181231 44911-0215_c217811c-f165-4ecf-aebf-f4481a15099f 44911-0215 HUMAN OTC DRUG Sciatica HP Aconitum Napellus, Aesculus Hippocastanum, Colocynthis, Gnaphalium Polycephalum, Hypericum Perforatum, Magnesia Phosphorica, Plumbum Metallicum, Rhus Tox, Arnica Montana LIQUID ORAL 20150714 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; HORSE CHESTNUT; CITRULLUS COLOCYNTHIS FRUIT PULP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; LEAD; TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 44911-0216_0404bf92-0266-4052-9e0f-4af65cba7557 44911-0216 HUMAN OTC DRUG Estrogens Estradiol, Estriol, Folliculinum LIQUID ORAL 20150723 UNAPPROVED HOMEOPATHIC Energique, Inc. ESTRADIOL; ESTRIOL; ESTRONE 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0217_ecdd7ccd-c241-4a43-8e80-92dfa4b39411 44911-0217 HUMAN OTC DRUG Neurostat Cimicifuga Racemosa, Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Cuprum Metallicum, Gelsemium Sempervirens, Lycopodium Clavatum, Phosphorus, Rhus Tox, Tarentula Cubensis, Latrodectus Mactans, Pyrogenium LIQUID ORAL 20150715 UNAPPROVED HOMEOPATHIC Energique, Inc. BLACK COHOSH; AMANITA MUSCARIA FRUITING BODY; PROTORTONIA CACTI; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; CITHARACANTHUS SPINICRUS; LATRODECTUS MACTANS; RANCID BEEF 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0218_c8f99e32-6dac-45bb-8624-ac6a5b71c150 44911-0218 HUMAN OTC DRUG ARNICA Arnica montana LIQUID ORAL 20150715 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. ARNICA MONTANA 30 wk/mL N 20181231 44911-0219_fd4ffd53-39d1-4326-9974-7978487d981e 44911-0219 HUMAN OTC DRUG EASTER LILY Lilium longiflorum LIQUID ORAL 20150715 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. LILIUM LONGIFLORUM BULB 12 [hp_X]/mL N 20181231 44911-0220_db29294e-e9f8-47f5-ab86-81af5a0aad65 44911-0220 HUMAN OTC DRUG COFFEE TEA CHOCOLATE ANTIGENS Lycopodium clavatum, Causticum, Kali bichromicum, Nux vomica, Oxalicum acidum, Pulsatilla (pratensis), Sepia, Cacao, Coffea cruda Thea sinensis LIQUID ORAL 20150715 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. LYCOPODIUM CLAVATUM SPORE; CAUSTICUM; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED; OXALIC ACID; PULSATILLA PRATENSIS; SEPIA OFFICINALIS JUICE; COCOA; ARABICA COFFEE BEAN; GREEN TEA LEAF 3; 12; 12; 12; 12; 12; 12; 13; 13; 13 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0221_e6009c22-6ff8-4fe8-8010-ef0b42d4028b 44911-0221 HUMAN OTC DRUG LINDEN FLOWER TINC Tilia europaea LIQUID ORAL 20150716 UNAPPROVED HOMEOPATHIC ENERGIQUE, INC. TILIA X EUROPAEA FLOWER 1 [hp_X]/mL N 20181231 44911-0222_cedaf4d5-412c-488c-b62b-70b75923046d 44911-0222 HUMAN OTC DRUG ASTHMATONE Echinacea (angustifolia), Lobelia inflata, Trifolium pratense, Arsenicum album, Carbo vegetabilis, Kali carbonicum, Natrum sulphuricum, Phosphorus, Pothos foetidus, Pulsatilla (pratensis) LIQUID ORAL 20150715 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; LOBELIA INFLATA; TRIFOLIUM PRATENSE FLOWER; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; POTASSIUM CARBONATE; SODIUM SULFATE; PHOSPHORUS; SYMPLOCARPUS FOETIDUS ROOT; PULSATILLA PRATENSIS 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0223_893acab9-5a57-4c77-aca8-20d66ffe43fe 44911-0223 HUMAN OTC DRUG Arnica Arnica Montana LIQUID ORAL 20150723 UNAPPROVED HOMEOPATHIC Energique, Inc. ARNICA MONTANA 1 [hp_M]/mL N 20181231 44911-0224_5b43c05e-43ab-4254-bcf2-10ea74378ec0 44911-0224 HUMAN OTC DRUG Impatiens Impatiens Glandulifera, Flos LIQUID ORAL 20150723 UNAPPROVED HOMEOPATHIC Energique, Inc. IMPATIENS GLANDULIFERA FLOWER 30 [hp_C]/mL N 20181231 44911-0225_04f05177-9c2e-458b-a1b4-dc7aa659cf9b 44911-0225 HUMAN OTC DRUG Rescue 5 Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos LIQUID ORAL 20150724 UNAPPROVED HOMEOPATHIC Energique, Inc. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 200; 200; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0226_6d225b1b-8d84-485c-9501-815dc4107cf2 44911-0226 HUMAN OTC DRUG Drainpar Propolis, Solidago Virgaurea, Trifolium Pratense, Hepar (Suis), Kidney (Suis), Lymph Node (Suis), Berberis Vulgaris, Bryonia (Alba), Ceanothus Americanus, Chelidonium Majus, Nux Vomica LIQUID ORAL 20150724 UNAPPROVED HOMEOPATHIC Energique, Inc. PROPOLIS WAX; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIFOLIUM PRATENSE FLOWER; PORK LIVER; PORK KIDNEY; SUS SCROFA LYMPH; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; STRYCHNOS NUX-VOMICA SEED 2; 2; 2; 6; 6; 6; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0227_5fb439f0-1270-469c-8b41-f1a0e689fcd8 44911-0227 HUMAN OTC DRUG Varico HP Calcarea Fluorica, Carbo Vegetabilis, Carduus Marianus, Hamamelis Virginiana, Lachesis Mutus, Lycopodium Clavatum, Pulsatilla (Pratensis), Secale Cornutum, Staphysagria, Zincum Metallicum LIQUID ORAL 20150724 UNAPPROVED HOMEOPATHIC Energique, Inc. CALCIUM FLUORIDE; ACTIVATED CHARCOAL; MILK THISTLE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PRATENSIS; CLAVICEPS PURPUREA SCLEROTIUM; DELPHINIUM STAPHISAGRIA SEED; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0228_08aad695-40b4-4f6d-a5f3-bb8b339692f4 44911-0228 HUMAN OTC DRUG Allerphenex I Acetaldehyde, Acetylcholine Chloride, Adrenalinum, Caffeic Acid, Chlorogenic Acid, Cinnamic Acid, Coumarinum, Cysteinum, Gallicum Acidum, Hepar Suis, Histaminum Hydrochloricum, Indolum, Malvin (Chloride), Mannan, Menadione, Norepinephrine, Octopamine, Pancreas Suis, Phenyl Isothiocyanate, Phloridzinum, Quercetin, Salsolinol (Hydrochloride), Serotonin (Hydrochloride), Candida Albicans, LIQUID ORAL 20151117 UNAPPROVED HOMEOPATHIC Energique, Inc. ACETALDEHYDE; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; CAFFEIC ACID; CHLOROGENIC ACID; CINNAMIC ACID; COUMARIN; CYSTEINE; GALLIC ACID MONOHYDRATE; PORK LIVER; HISTAMINE DIHYDROCHLORIDE; INDOLE; MALVIN; YEAST MANNAN; MENADIONE; NOREPINEPHRINE; OCTOPAMINE; SUS SCROFA PANCREAS; PHENYL ISOTHIOCYANATE; PHLORIZIN; QUERCETIN; SALSOLINOL HYDROCHLORIDE; SEROTONIN HYDROCHLORIDE; CANDIDA ALBICANS 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [IR]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0229_07a65309-130d-454a-b9ea-193eee034103 44911-0229 HUMAN OTC DRUG Inflammation Miasm Astragalus Membranaceus, Echinacea (Angustifolia), Scrophularia Nodosa, Tabebuia Impetiginosa, Thyroidinum (Suis), Formicum Acidum, Phosphorus, Silicea, Sulphur, Thuja Occidentalis, Aurum Metallicum LIQUID ORAL 20150727 UNAPPROVED HOMEOPATHIC Energique, Inc. ASTRAGALUS PROPINQUUS ROOT; ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; TABEBUIA IMPETIGINOSA BARK; THYROID, PORCINE; FORMIC ACID; PHOSPHORUS; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; GOLD 3; 3; 3; 3; 8; 10; 10; 10; 10; 10; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0230_c68f1755-1819-4be5-9445-4dc6a10d0631 44911-0230 HUMAN OTC DRUG Arteriotone Baptisia Tinctoria, Cactus Grandiflorus, Echinacea (Angustifolia), Adonis Vernalis, Agnus Castus, Arnica Montana, Aurum Metallicum, Digitalis Purpurea, Glonoinum, Vanadium Metallicum LIQUID ORAL 20150727 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; SELENICEREUS GRANDIFLORUS STEM; ECHINACEA ANGUSTIFOLIA; ADONIS VERNALIS; CHASTE TREE; ARNICA MONTANA; GOLD; DIGITALIS; NITROGLYCERIN; VANADIUM 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0231_00ccb751-f98e-4334-90d2-5aba07802d03 44911-0231 HUMAN OTC DRUG Metalstat Allium Sativum, Avena Sativa, Berberis Vulgaris, Lappa Major, Phytolacca Decandra, Solidago Virgaurea, Lycopodium Clavatum, Nux Vomica, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum LIQUID ORAL 20150806 UNAPPROVED HOMEOPATHIC Energique, Inc. GARLIC; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; LANTHANUM; NIOBIUM; TANTALUM 3; 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 14; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0232_9bff172a-d52a-40af-8aff-2eebc3ad7372 44911-0232 HUMAN OTC DRUG White Chestnut Aesculus Hippocastanum, Flos LIQUID ORAL 20150727 UNAPPROVED HOMEOPATHIC Energique, Inc. AESCULUS HIPPOCASTANUM FLOWER 30 [hp_X]/mL N 20181231 44911-0233_1e9a11ab-a4ec-4ff4-9ec1-053932ece00f 44911-0233 HUMAN OTC DRUG Spleenex V Aralia Quinquefolia, Magnesium Gluconicum Dihydricum, Potassium Gluconate, Ginkgo Biloba, Pancreas Suis, Spleen (Suis), Stomach, Germanium Sesquioxide, Cuprum Metallicum, Zincum Metallicum, alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Magnesia Phosphorica, Malic Acid, Oxaloacetic Acid, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Aconitum Acidum, Cis- LIQUID ORAL 20150730 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; MAGNESIUM GLUCONATE; POTASSIUM GLUCONATE; GINKGO; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; GERMANIUM SESQUIOXIDE; COPPER; ZINC; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MALIC ACID; OXALOACETIC ACID; PYRUVIC ACID; SUCCINIC ACID; 1,4-NAPHTHOQUINONE; ACONITIC ACID, (Z)- 3; 3; 3; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0234_a16ab715-dd2b-4724-8e6d-7011d3fe4300 44911-0234 HUMAN OTC DRUG Septastat Baptisia Tinctoria, Echinacea (Angustifolia), Anthracinum, Arsenicum Album, Belladonna, Crotalus Horridus, Hyoscyamus Niger, Lachesis Mutus, Pyrogenium, Tarentula Cubensis LIQUID ORAL 20150806 20200825 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CROTALUS HORRIDUS HORRIDUS VENOM; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; RANCID BEEF; CITHARACANTHUS SPINICRUS 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0235_29b99fea-dd23-4850-a5a6-c5fe3afc6a2b 44911-0235 HUMAN OTC DRUG Lungex II Ginkgo Biloba, Colon (Suis), Lung (Suis), Pancreas Suis, Germanium Sesquioxide, Cuprum Metallicum, Manganum Metallicum, Stannum Metallicum, alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malic Acid, Oxaloacetic Acid, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Arsenicum Metallicum, Calcarea Carbonica, Aconiticum Acidum, Cis, Phosphorus LIQUID ORAL 20150807 UNAPPROVED HOMEOPATHIC Energique, Inc. GINKGO; SUS SCROFA COLON; SUS SCROFA LUNG; SUS SCROFA PANCREAS; GERMANIUM SESQUIOXIDE; COPPER; MANGANESE; TIN; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MALIC ACID; OXALOACETIC ACID; PYRUVIC ACID; SUCCINIC ACID; 1,2-NAPHTHOQUINONE; ARSENIC; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACONITIC ACID, (Z)-; PHOSPHORUS 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0236_af8e05fe-5646-4d01-80a6-b0edee6cccf2 44911-0236 HUMAN OTC DRUG Spleenex VH Aralia Quinquefolia, Ginkgo Biloba, Pancreas Suis, Spleen (Suis), Stomach (Suis), Germanium Sesquioxide, Cobaltum Metallicum, Niccolum Metallicum, Zincum Metallicum, alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malic Acid, Oxaloacetic Acid, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Baryta Carbonica, Phosphoricum Acidum, Aconitum Acidum, Cis-, Magnesium Gluconicum Dihydricum, Nux Vomica, Phosphorus LIQUID ORAL 20150810 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; GINKGO; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; GERMANIUM SESQUIOXIDE; COBALT; NICKEL; ZINC; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MALIC ACID; OXALOACETIC ACID; PYRUVIC ACID; SUCCINIC ACID; 1,4-NAPHTHOQUINONE; BARIUM CARBONATE; PHOSPHORIC ACID; ACONITIC ACID, (Z)-; MAGNESIUM GLUCONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0237_988caec1-2e83-4f3e-8f5c-9d30f0d279c1 44911-0237 HUMAN OTC DRUG Candida Albicans Phenolic Candida Albicans LIQUID ORAL 20150819 UNAPPROVED HOMEOPATHIC Energique, Inc. CANDIDA ALBICANS 12 [hp_X]/mL N 20181231 44911-0238_696083fb-74b7-4280-8593-e05042d4e1dd 44911-0238 HUMAN OTC DRUG Rescue 5 Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos LIQUID ORAL 20150730 UNAPPROVED HOMEOPATHIC Energique, Inc. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0239_c7743d08-1302-4088-b305-a8c83ae588a5 44911-0239 HUMAN OTC DRUG Lyme HP Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Borrelia Burgdorferi Nosode, Encephalitis Nosode, Meningococcus Nosode, Hepatitis B Nosode, Arsenicum Album, Bryonia (Alba), Chelidonium Majus, Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre, Lycopodium Clavatum, Phosphorus, Rhus Tox LIQUID ORAL 20150810 20200911 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; BORRELIA BURGDORFERI; JAPANESE ENCEPHALITIS VIRUS; NEISSERIA MENINGITIDIS; HEPATITIS B VIRUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 12; 12; 15; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0240_47bed8ef-590a-422e-8d71-a91339426b29 44911-0240 HUMAN OTC DRUG Multi-Phenolic Serotonin Hydrochloride, 5-Hydroxytryptophan, Acetaldehyde, Acetylcholine Chloride, Apiolum, Ascorbic Acid, Aspartame, Butylated Hydroxytoluene, Caffeic Acid, Chlorogenic Acid, Cinnamic Acid, Coniferyl Alcohol, Coumarinum, Dopamine Hydrochloride, Estradiol, Gallicum Acidum, Gamma Aminobutyric Acid, Histaminum Hydrochloricum, Hydrocortisone (Cortisol), Indolum, L-Dopa, Malvin, Mannan, Melatonin, Menadione, Norepinephrine, Octopamine, Phenyl Isothiocyanate, Phloridzinum, Piperine, Progesterone, Pyrrole LIQUID ORAL 20150811 UNAPPROVED HOMEOPATHIC Energique, Inc. SEROTONIN HYDROCHLORIDE; OXITRIPTAN; ACETALDEHYDE; ACETYLCHOLINE CHLORIDE; APIOLE (PARSLEY); ASCORBIC ACID; ASPARTAME; BUTYLATED HYDROXYTOLUENE; CAFFEIC ACID; CHLOROGENIC ACID; CINNAMIC ACID; CONIFERYL ALCOHOL; COUMARIN; DOPAMINE HYDROCHLORIDE; ESTRADIOL; GALLIC ACID MONOHYDRATE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE DIHYDROCHLORIDE; HYDROCORTISONE; INDOLE; LEVODOPA; MALVIN; YEAST MANNAN; MELATONIN; MENADIONE; NOREPINEPHRINE; OCTOPAMINE HYDROCHLORIDE; PHENYL ISOTHIOCYANATE; PHENYLALANINE; PHLORIZIN; PIPERINE; PROGESTERONE; PYRROLE; QUERCETIN; RUTIN; SALSOLINOL HYDROCHLORIDE; TAURINE; CANDIDA ALBICANS 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0241_bd6aec55-2622-4f37-9a9e-78fb7320ce21 44911-0241 HUMAN OTC DRUG Arnica Arnica Montana LIQUID ORAL 20150811 UNAPPROVED HOMEOPATHIC Energique, Inc. ARNICA MONTANA 200 [hp_C]/mL N 20181231 44911-0242_5072b4e3-4365-45d5-afcd-1dd4c3d06f85 44911-0242 HUMAN OTC DRUG Elimitone Bellis Perennis, Echinacea (Angustifolia), Phytolacca Decandra, Trifolium Pratense, Arnica Montana, Calcarea Iodata, Kali Muriaticum, Nitricum Acidum, Oscillococcinum, Phosphoricum Acidum, Sulphur Iodatum LIQUID ORAL 20150923 UNAPPROVED HOMEOPATHIC Energique, Inc. BELLIS PERENNIS; ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; TRIFOLIUM PRATENSE FLOWER; ARNICA MONTANA; CALCIUM IODIDE; POTASSIUM CHLORIDE; NITRIC ACID; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; PHOSPHORIC ACID; SULFUR IODIDE 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0243_c70908d5-07ce-4331-ac51-2d35f8506dc3 44911-0243 HUMAN OTC DRUG Free Radistat Baptisia Tinctoria, Echinacea (Angustifolia), Fucus Vesiculosus, Phytolacca Decandra, Uva-Ursi, Arsenicum Album, Aurum Metallicum, Ferrum Phosphoricum, Iodium, Iridium Metallicum, Lachesis Mutus, Zincum Metallicum, Cadmium Sulphuratum LIQUID ORAL 20150814 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; FUCUS VESICULOSUS; PHYTOLACCA AMERICANA ROOT; ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; GOLD; FERROSOFERRIC PHOSPHATE; IODINE; IRIDIUM; LACHESIS MUTA VENOM; ZINC; CADMIUM SULFIDE 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 13 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0244_9f8f4986-17dd-47fb-8360-b24c458b0af7 44911-0244 HUMAN OTC DRUG Edema HP Apis Mellifica, Apocynum Cannabinum, Arsenicum Album, Digitalis Purpurea, Lycopodium Clavatum, Rhus Tox, Sambucus Nigra, Strophanthus Hispidus LIQUID ORAL 20150824 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; APOCYNUM CANNABINUM ROOT; ARSENIC TRIOXIDE; DIGITALIS; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0245_9a0220b9-8376-4722-a968-67bd11be4353 44911-0245 HUMAN OTC DRUG Syphilitic Miasm Phytolacca Decandra, Anacardium Orientale, Arsenicum Album, Aurum Metallicum, Mercurius Solubilis, Nitricum Acidum, Thuja Occidentalis LIQUID ORAL 20150827 UNAPPROVED HOMEOPATHIC Energique, Inc. PHYTOLACCA AMERICANA ROOT; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; GOLD; MERCURIUS SOLUBILIS; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0247_45650335-16a2-4a28-8e16-16538856e0db 44911-0247 HUMAN OTC DRUG Melatonin Phenolic Melatonin LIQUID ORAL 20150814 UNAPPROVED HOMEOPATHIC Energique, Inc. MELATONIN 6 [hp_X]/mL N 20181231 44911-0248_d55b0025-91aa-40e1-a282-94a036345938 44911-0248 HUMAN OTC DRUG Menopause HP Belladonna, Lachesis Mutus, Manganum Aceticum, Nux Vomica, Pulsatilla (Pratensis), Secale Cornutum, Sepia, Ustilago Maidis LIQUID ORAL 20150827 UNAPPROVED HOMEOPATHIC Energique, Inc. ATROPA BELLADONNA; LACHESIS MUTA VENOM; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA PRATENSIS; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; USTILAGO MAYDIS 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0249_f0004b5f-4239-4265-9a33-119f5def6cf5 44911-0249 HUMAN OTC DRUG Renatone Berberis Vulgaris, Solidago Virgaurea, Cantharis, Arsenicum Album, Coccus Cacti, Lycopodium Clavatum, Phosphorus, Senecio Aureus LIQUID ORAL 20150827 UNAPPROVED HOMEOPATHIC Energique, Inc. BERBERIS VULGARIS ROOT BARK; SOLIDAGO VIRGAUREA FLOWERING TOP; LYTTA VESICATORIA; ARSENIC TRIOXIDE; PROTORTONIA CACTI; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PACKERA AUREA 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0250_473c2359-fb49-485a-abd2-f0ea9e830df0 44911-0250 HUMAN OTC DRUG Coxsackie Cord Coxsackie Nosode A3, A4, A5, A7, B1, B3, B5 LIQUID ORAL 20150923 UNAPPROVED HOMEOPATHIC Energique, Inc. HUMAN COXSACKIEVIRUS A; HUMAN COXSACKIEVIRUS A7; HUMAN COXSACKIEVIRUS B; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B3 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0251_222d4cfe-cad2-4a52-98b1-c20b3ec6ed47 44911-0251 HUMAN OTC DRUG Neuropar Passiflora Incarnata, Glandula Suprarenalis Suis, Thyroidinum (Bovine), Aranea Diadema, Arnica Montana, Arsenicum Album, Hypericum Perforatum, Lachesis Mutus, Physostigma Venenosum, Zincum Picricum LIQUID ORAL 20150831 UNAPPROVED HOMEOPATHIC Energique, Inc. PASSIFLORA INCARNATA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; THYROID, BOVINE; ARANEUS DIADEMATUS; ARNICA MONTANA; ARSENIC TRIOXIDE; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; PHYSOSTIGMA VENENOSUM SEED; ZINC PICRATE NONAHYDRATE 3; 6; 6; 12; 12; 12; 12; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0252_75e9f9a3-e655-4fac-9856-b8ddf3f32b00 44911-0252 HUMAN OTC DRUG Pneumopar Lobelia Inflata, Symphytum Officinale, Lung (Suis), Arsenicum Album, Blatta Orientalis, Bryonia (Alba), Phosphorus, Silicea, Sulphur LIQUID ORAL 20150831 20200914 UNAPPROVED HOMEOPATHIC Energique, Inc. LOBELIA INFLATA; COMFREY ROOT; SUS SCROFA LUNG; ARSENIC TRIOXIDE; BLATTA ORIENTALIS; BRYONIA ALBA ROOT; PHOSPHORUS; SILICON DIOXIDE; SULFUR 3; 3; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0253_1106d2ae-8fa4-43b7-b69b-21fd6dc36f26 44911-0253 HUMAN OTC DRUG Coniferyl Alcohol Phenolic Coniferyl Alcohol LIQUID ORAL 20150831 UNAPPROVED HOMEOPATHIC Energique, Inc. CONIFERYL ALCOHOL 6 [hp_X]/mL N 20181231 44911-0254_781ae9e4-9461-4a76-af41-38a42291c165 44911-0254 HUMAN OTC DRUG Pneumotone Lobelia Inflata, Verbascum Thapsus, Balsamum Peruvianum, Antimonium Tartaricum, Arsenicum Album, Drosera (Rotundifolia), Kali Bichromicum, Kali Carbonicum, Natrum Sulphuricum, Phosphorous, Spongia Tosta LIQUID ORAL 20150831 UNAPPROVED HOMEOPATHIC Energique, Inc. LOBELIA INFLATA; VERBASCUM THAPSUS; BALSAM PERU; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; DROSERA ROTUNDIFOLIA; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; SODIUM SULFATE; PHOSPHORUS; SPONGIA OFFICINALIS SKELETON, ROASTED 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0255_f5e1e2cf-e3f2-422e-851d-55a34ba44a4d 44911-0255 HUMAN OTC DRUG Allergic Reaction Rescue Apis Mellifica LIQUID ORAL 20150903 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA 12 [hp_X]/mL N 20181231 44911-0256_4ee9ab29-6026-4cee-8019-b9300d495755 44911-0256 HUMAN OTC DRUG Gallbladderpar Carduus Marianus, Fel Tauri, Taraxacum Officinale, Chelidonium Majus, Lycopodium Clavatum, Magnesia Phosphorica, Natrum Sulphuricum, Nux Vomica, Phosphorus, Sanguinaria Canadensis, Gallbladder (Suis) LIQUID ORAL 20150903 UNAPPROVED HOMEOPATHIC Energique, Inc. MILK THISTLE; BOS TAURUS BILE; TARAXACUM OFFICINALE; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SANGUINARIA CANADENSIS ROOT; SUS SCROFA GALLBLADDER 3; 6; 6; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0257_54d9a51a-898f-4ebc-beb1-9c2902825d69 44911-0257 HUMAN OTC DRUG Lymestat Chelidonium Majus, Echinacea, Hydrastis Canadensis, Arsenicum Album, Bryonia (Alba), Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre, Lycopodium Clavatum, Phosphorus, Rhus Tox LIQUID ORAL 20150904 20201002 UNAPPROVED HOMEOPATHIC Energique, Inc. CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0258_a3e8cd6b-af7e-4f11-b9f7-daebf1df0fd2 44911-0258 HUMAN OTC DRUG Menotone Angelica Archangelica, Cimicifuga Racemosa, Belladonna, Lachesis Mutus, Pulsatilla (Pratensis), Sabina, Sanguinaria Canadensis, Sepia, Sulphur LIQUID ORAL 20150904 UNAPPROVED HOMEOPATHIC Energique, Inc. ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; ATROPA BELLADONNA; LACHESIS MUTA VENOM; PULSATILLA PRATENSIS; JUNIPERUS SABINA LEAFY TWIG; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFUR 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0259_e1e904d2-3d7f-465b-9c7b-70b03c561ada 44911-0259 HUMAN OTC DRUG Hepatone Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus LIQUID ORAL 20150904 UNAPPROVED HOMEOPATHIC Energique, Inc. MILK THISTLE; CHELIDONIUM MAJUS; TARAXACUM OFFICINALE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0260_429815b6-30bb-43a0-97c3-adbdd30798e0 44911-0260 HUMAN OTC DRUG Shark Cartilage Cord Shark Cartilage LIQUID ORAL 20150904 UNAPPROVED HOMEOPATHIC Energique, Inc. SHARK CARTILAGE 6 [hp_C]/mL N 20181231 44911-0261_7cad2afe-5034-4bb7-b9aa-8ef58dad0f3f 44911-0261 HUMAN OTC DRUG Spleenpar Spleen (Suis), Arsenicum Album, Carbo Vegetabilis, Ceanothus Americanus, Chininum Sulphuricum, Ignatia Amara, Iodium, Natrum Muriaticum, Nitricum Acidum, Phosphoricum Acidum, Phosphorus LIQUID ORAL 20150904 UNAPPROVED HOMEOPATHIC Energique, Inc. SUS SCROFA SPLEEN; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; CEANOTHUS AMERICANUS LEAF; QUININE SULFATE; STRYCHNOS IGNATII SEED; IODINE; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORIC ACID; PHOSPHORUS 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0262_24658d20-412b-4ccd-9135-68e4381321f6 44911-0262 HUMAN OTC DRUG Infectone Astragalus Membranaceus, Phytolacca Decandra, Scrophularia Nodosa, Baptisia Tinctoria, Aconitum Napellus, Arnica Montana, Lachesis Mutus, Pyrogenium LIQUID ORAL 20150908 UNAPPROVED HOMEOPATHIC Energique, Inc. ASTRAGALUS PROPINQUUS ROOT; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; BAPTISIA TINCTORIA ROOT; ACONITUM NAPELLUS; ARNICA MONTANA; LACHESIS MUTA VENOM; RANCID BEEF 3; 3; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0263_3cbcf466-4c80-4552-ba31-39e021450849 44911-0263 HUMAN OTC DRUG Trace Mineral Cord Aluminum, Antimony, Barium, Beryllium, Bismuth, Boron, Bromine, Calcium, Carbon, Cerium, Cesium, Chloride, Chromium, Cobalt, Copper, Dysprosium, Erbium, Europium, Fluoride, Gadolinium, Gallium, Germanium, Gold, Hafnium, Holmium, Indium, Iodine, Iridium, Iron, Lanthanum, Lithium, Lutetium, Magnesium, Manganese, Molybdenum, Neodymium, Nickel, Niobium, Osmium, Palladium, Phosphorus, Platinum, Potassium, Praseodymium, Rhenium, Rhodium, Rubidium, Ruthenium, Samarium, Scandium, Selenium, Silicon, Silver LIQUID ORAL 20150924 UNAPPROVED HOMEOPATHIC Energique, Inc. ACTIVATED CHARCOAL; IRON; SULFUR; MAGNESIUM; ALUMINUM; CALCIUM; SILICON; PHOSPHORUS; CHLORIDE ION; MANGANESE; ZINC; POTASSIUM; LANTHANUM; NICKEL; SELENIUM; BERYLLIUM; VANADIUM; BORON; YTTRIUM; STRONTIUM; GADOLINIUM; COBALT; FLUORIDE ION; NEODYMIUM; CHROMIUM; TELLURIUM; BROMINE; COPPER; LITHIUM; ANTIMONY; TITANIUM; ZIRCONIUM; RUBIDIUM; SODIUM; THULIUM; MOLYBDENUM; SAMARIUM; YTTERBIUM; IODINE; CERIUM; DYSPROSIUM; PRASEODYMIUM; SCANDIUM; ERBIUM; LUTETIUM; GALLIUM; THORIUM; TUNGSTEN; BARIUM; TIN; BISMUTH; HOLMIUM; TANTALUM; TERBIUM; GERMANIUM; INDIUM; THALLIUM; CESIUM; RUTHENIUM; SILVER; EUROPIUM; NIOBIUM; HAFNIUM; RHENIUM; GOLD; IRIDIUM; OSMIUM; PALLADIUM; PLATINUM; RHODIUM 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0264_daee3f0f-b0fe-4916-a6f9-20249ca3fea6 44911-0264 HUMAN OTC DRUG 5-HTP Phenolic 5-Hydroxytryptophan LIQUID ORAL 20150908 UNAPPROVED HOMEOPATHIC Energique, Inc. OXITRIPTAN 6 [hp_X]/mL N 20181231 44911-0265_1edcf5a1-6c10-4d8b-b2f0-e98209b4489b 44911-0265 HUMAN OTC DRUG Parasite Infection Arsenicum Album, Baptisia Tinctoria, Lachesis Mutus, Pulsatilla (Pratensis), Rhus Tox LIQUID ORAL 20150908 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; LACHESIS MUTA VENOM; PULSATILLA PRATENSIS; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0266_cda2908b-289e-42ba-82c5-e9dc8c8194a1 44911-0266 HUMAN OTC DRUG Pituistat Aralia quinquefolia, Ginkgo biloba, Arsenicum iodatum, Avena sativa, Baryta carbonica, Phosphorus, Silicea, Thyroidinum (suis), Aluminum, Antimony, Barium, Beryllium, Bismuth, Boron, Bromine, Calcium, Carbon, Cerium, Cesium, Chloride, Chromium, Cobalt, Copper, Dysprosium, Erbium, Europium, Fluoride, Gadolinium, Gallium, Germanium, Gold, Hafnium, Holmium, Indium, Iodine, Iridium, Iron, Lanthanum, Lithium, Lutetium, Magnesium, Manganese, Molybdenum, Neodymium, Nickel, Niobium, Osmium, Palladium LIQUID ORAL 20150924 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; GINKGO; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; PHOSPHORUS; SILICON DIOXIDE; THYROID, PORCINE; ALUMINUM; ANTIMONY; BARIUM; BERYLLIUM; BISMUTH; BORON; BROMINE; CALCIUM; ACTIVATED CHARCOAL; CERIUM; CESIUM; CHLORIDE ION; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; FLUORIDE ION; GADOLINIUM; GALLIUM; GERMANIUM; GOLD; HAFNIUM; HOLMIUM; INDIUM; IODINE; IRIDIUM; IRON; LANTHANUM; LITHIUM; LUTETIUM; MAGNESIUM; MANGANESE; MOLYBDENUM; NEODYMIUM; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; POTASSIUM; PRASEODYMIUM; RHENIUM; RHODIUM; RUBIDIUM; RUTHENIUM; SAMARIUM; SCANDIUM; SELENIUM; SILICON; SILVER; SODIUM; STRONTIUM; SULFUR; TANTALUM; TELLURIUM; TERBIUM; THALLIUM; THORIUM; THULIUM; TIN; TITANIUM; TUNGSTEN; VANADIUM; YTTERBIUM; YTTRIUM; ZINC; ZIRCONIUM 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0267_65cdbf69-37cf-41c7-bbf5-341445af880e 44911-0267 HUMAN OTC DRUG Neuralgia HP Aconitum napellus, Agaricus muscarius, Allium cepa, Arnica montana, Coffea cruda, Hypericum perforatum, Lycopodium clavatum, Mercurius solubilis, Phosphorus, Plumbum metallicum LIQUID ORAL 20150923 UNAPPROVED HOMEOPATHIC Energique, Inc. ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; ONION; ARNICA MONTANA; ARABICA COFFEE BEAN; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHOSPHORUS; LEAD 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0268_d51e6fe8-6992-49db-a856-268b0a4afe44 44911-0268 HUMAN OTC DRUG Allerstat I Chelidonium Majus, Echinacea (Angustifolia), Gentiana Lutea, Arsenicum Album, Carbo Vegetabilis, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla (Pratensis) LIQUID ORAL 20151020 UNAPPROVED HOMEOPATHIC Energique, Inc. CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GENTIANA LUTEA ROOT; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA PRATENSIS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0269_7c54b9a0-5afa-4de8-bdc6-5272013a0191 44911-0269 HUMAN OTC DRUG Bio Immune Chelidonium Majus, Lobelia Inflata, Rumex Crispus, Sambucus Nigra, Scrophularia Nodosa, Senega Officinalis, Spongia Tosta, Taraxacum Officinale, Myristica Sebifera, Sticta Pulmonaria, Sulphur, Ustilago Maidis, Polyporus Officinalis, Candida Albicans, Carduus Marianus, Crotalus Horridus, Agaricus Muscarius, Bovista, Secale Cornutum, Anas Barbariae, Hepatis Et Cordis Extractum, Anthracinum, Arsenicum Album, Baptisia Tinctoria, Berberis Vulgaris, Botulinum, Dysentery Bacillus, Gaertner Bacillus LIQUID ORAL 20150924 UNAPPROVED HOMEOPATHIC Energique, Inc. CHELIDONIUM MAJUS; LOBELIA INFLATA; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SCROPHULARIA NODOSA; POLYGALA SENEGA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; TARAXACUM OFFICINALE; VIROLA SEBIFERA RESIN; LOBARIA PULMONARIA; SULFUR; USTILAGO MAYDIS; LARICIFOMES OFFICINALIS FRUITING BODY; CANDIDA ALBICANS; MILK THISTLE; CROTALUS HORRIDUS HORRIDUS VENOM; AMANITA MUSCARIA FRUITING BODY; LYCOPERDON UTRIFORME FRUITING BODY; CLAVICEPS PURPUREA SCLEROTIUM; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BOTULINUM TOXIN TYPE A; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; INFLUENZA A VIRUS; INFLUENZA B VIRUS; VACCINIA VIRUS; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; STREPTOCOCCUS PNEUMONIAE; RANCID BEEF; VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 8; 12; 12; 12; 10; 10; 10; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0270_daaaa59e-c064-423e-8c10-bc477402a946 44911-0270 HUMAN OTC DRUG Psora Miasm Eggshell Membrane, Whey Protein, Arsenicum Album, Croton Tiglium, Hydrocotyle Asiatica, Natrum Muriaticum LIQUID ORAL 20150929 UNAPPROVED HOMEOPATHIC Energique, Inc. EGG SHELL MEMBRANE; WHEY; ARSENIC TRIOXIDE; CROTON TIGLIUM SEED; CENTELLA ASIATICA; SODIUM CHLORIDE 6; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0271_572ae8b0-454b-46fd-9960-dd5330a59411 44911-0271 HUMAN OTC DRUG Calc Fluor Calcarea Fluorica LIQUID ORAL 20150930 UNAPPROVED HOMEOPATHIC Energique, Inc. CALCIUM FLUORIDE 200 [hp_C]/mL N 20181231 44911-0272_5f189d0b-4984-439c-865f-a288ed2cd3f5 44911-0272 HUMAN OTC DRUG Regen HP Cinnamomum, Echinacea (Angustifolia), Hydrastis Canadensis, Lappa Major, Trifolium Pratense LIQUID ORAL 20150930 UNAPPROVED HOMEOPATHIC Energique, Inc. CINNAMON; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; ARCTIUM LAPPA ROOT; TRIFOLIUM PRATENSE FLOWER 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0273_a9051dfe-8ded-4761-94c9-58fa1b1fc485 44911-0273 HUMAN OTC DRUG Bronchi HP Carbo Vegetabilis, Cuprum Metallicum, Drosera (Rotundifolia) Hepar Sulphuris Calcareum, Ipecacuanha, Lachesis Mutus, Lobelia Inflata, Phosphorus, Pulsatilla (Vulgaris), Rumex Crispus, Spongia Tosta LIQUID ORAL 20150930 UNAPPROVED HOMEOPATHIC Energique, Inc. ACTIVATED CHARCOAL; COPPER; DROSERA ROTUNDIFOLIA; CALCIUM SULFIDE; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; ANEMONE PULSATILLA WHOLE; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0274_832fc1db-ed5a-44e5-abb2-5c68d220e06f 44911-0274 HUMAN OTC DRUG Pneumostat Echinacea (Angustifolia), Hydrastis Canadensis, Hypericum Perforatum, Symphytum Officinale, Arsenicum Album, Causticum, Kali Carbonicum, Natrum Sulphuricum, Phosphorus, Pulsatilla (Pratensis), Silicea LIQUID ORAL 20150930 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HYPERICUM PERFORATUM; COMFREY ROOT; ARSENIC TRIOXIDE; CAUSTICUM; POTASSIUM CARBONATE; SODIUM SULFATE; PHOSPHORUS; PULSATILLA PRATENSIS; SILICON DIOXIDE 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 44911-0275_5eb79c76-7fde-4db8-b00e-cdf6e25f67d2 44911-0275 HUMAN OTC DRUG Cortisol Phenolic Hydrocortisone LIQUID ORAL 20151001 UNAPPROVED HOMEOPATHIC Energique, Inc. HYDROCORTISONE 6 [hp_X]/mL N 20181231 44911-0276_57689ac0-7116-4847-8317-031e7f85d2b5 44911-0276 HUMAN OTC DRUG Gastropar Gentiana Lutea, Sambucus Nigra, Symphytum Officinale, Stomach (Suis), Arsenicum Album, Bismuthum Subnitricum, Carbo Vegetabilis, Lycopodium Clavatum, Nux Vomica, Phosphorus LIQUID ORAL 20151001 UNAPPROVED HOMEOPATHIC Energique, Inc. GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; COMFREY ROOT; SUS SCROFA STOMACH; ARSENIC TRIOXIDE; BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 3; 3; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0277_7d398b59-0893-434c-a5fd-eefd77fa7292 44911-0277 HUMAN OTC DRUG Nux Vom Nux Vomica LIQUID ORAL 20151001 UNAPPROVED HOMEOPATHIC Energique, Inc. STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/mL N 20181231 44911-0278_7fc5ab51-f51a-4887-bcdc-d052415062ab 44911-0278 HUMAN OTC DRUG Postpituapar Apis Mellifica, Arsenicum Album, Lachesis Mutus, Nux Vomica, Phosphoricum Acidum, Pituitarum Posterium (Bovine), Pulsatilla (Pratensis), Sambucus Nigra, Thuja Occidentalis LIQUID ORAL 20151001 UNAPPROVED HOMEOPATHIC Energique, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; LACHESIS MUTA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; BOS TAURUS PITUITARY GLAND, POSTERIOR; PULSATILLA PRATENSIS; SAMBUCUS NIGRA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0279_8cebdf61-88d3-4a18-bf85-5ebdc06fe8d4 44911-0279 HUMAN OTC DRUG Gynestat Cimicifuga Racemosa, Eucalyptus Globulus, Argentum Nitricum, Calcarea Carbonica, Kali Bichromicum, Kreosotum, Mercurius Solubilis, Pulsatilla (Pratensis), Sepia, Staphysagria, Thuja Occidentalis LIQUID ORAL 20151023 UNAPPROVED HOMEOPATHIC Energique, Inc. BLACK COHOSH; EUCALYPTUS GLOBULUS LEAF; SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; WOOD CREOSOTE; MERCURIUS SOLUBILIS; PULSATILLA PRATENSIS; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL; 1/mL N 20181231 44911-0280_217fb1b8-67bf-44aa-8bcb-c85111ecfb2e 44911-0280 HUMAN OTC DRUG Renapar Pareira Brava, Petroselinum Sativum, Sarsaparilla (Smilax Regelii), Kidney (Suis), Bryonia (Alba), Mercurius Corrosivus, Rubia Tinctorum, Solidago Virgaurea, Triticum Repens LIQUID ORAL 20151023 UNAPPROVED HOMEOPATHIC Energique, Inc. CHONDRODENDRON TOMENTOSUM ROOT; PETROSELINUM CRISPUM; SMILAX REGELII ROOT; PORK KIDNEY; BRYONIA ALBA ROOT; MERCURIC CHLORIDE; RUBIA TINCTORUM ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; ELYMUS REPENS ROOT 3; 3; 3; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0281_fe281bee-03a6-4fc4-8d73-f0f505b9c80a 44911-0281 HUMAN OTC DRUG Systemistat Berberis Vulgaris, Chelidonium Majus, Hydrastis Canadensis, Lappa Major, Hepar Sulphuris Calcareum, Lycopodium Clavatum, Sulphur, Calcarea Carbonica, Mercurius Solubilis, Thuja Occidentalis LIQUID ORAL 20151023 UNAPPROVED HOMEOPATHIC Energique, Inc. BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; GOLDENSEAL; ARCTIUM LAPPA ROOT; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MERCURIUS SOLUBILIS; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 12; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0282_229f4395-f9de-4fa7-9845-5b13a9368772 44911-0282 HUMAN OTC DRUG Norepinephrine Phenolic Norepinephrine LIQUID ORAL 20151026 UNAPPROVED HOMEOPATHIC Energique, Inc. NOREPINEPHRINE 6 [hp_X]/mL N 20181231 44911-0283_f139eeb6-e687-478e-919c-6808fab9a71b 44911-0283 HUMAN OTC DRUG Vaccistat Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Antimonium Tartaricum, Mezereum, Mercurius Solubilis, Silicea, Thuja Occidentalis, Malandrinum, Variolinum LIQUID ORAL 20151026 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; ANTIMONY POTASSIUM TARTRATE; DAPHNE MEZEREUM BARK; MERCURIUS SOLUBILIS; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; VACCINIA VIRUS; VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 3; 3; 3; 12; 12; 30; 30; 30; 60; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 44911-0284_85e7a7c7-23d3-438f-bef4-dcbdbcf9f06c 44911-0284 HUMAN OTC DRUG Liverex I Ginkgo Biloba, Fel Tauri, Gallbladder (Suis), Hepar Suis, Thyroidinum (Suis), Germanium Sesquioxide, Aconitum Acidum, Cis-, alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malic Acid, Manganum Metallicum, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Sulphur, Lycopodium Clavatum, Phosphorus LIQUID ORAL 20151111 UNAPPROVED HOMEOPATHIC Energique, Inc. GINKGO; BOS TAURUS BILE; SUS SCROFA GALLBLADDER; PORK LIVER; THYROID, PORCINE; GERMANIUM SESQUIOXIDE; ACONITIC ACID, (Z)-; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MALIC ACID; MANGANESE; PYRUVIC ACID; SUCCINIC ACID; 1,2-NAPHTHOQUINONE; ARSENIC; SULFUR; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0285_998dc972-d34c-45f0-9a41-9ef9b8e8b708 44911-0285 HUMAN OTC DRUG V HP Arsenicum Album, Belladonna, Carcinosin, Echinacea (Angustifolia), Eupatorium Perfoliatum, Gelsemium Sempervirens, Lycopodium Clavatum, Phosphoricum Acidum, Phosphorus, Pyrogenium, Rhus Tox LIQUID ORAL 20151026 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; HUMAN BREAST TUMOR CELL; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0286_487d05cf-684b-473e-9f27-462bfa0d26b1 44911-0286 HUMAN OTC DRUG Industristat Plantago Major, Symphytum Officinale, Taraxacum Officinale, Trifolium Pratense, Arsenicum Album, Cadmium Sulphuratum, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20151026 UNAPPROVED HOMEOPATHIC Energique, Inc. PLANTAGO MAJOR; COMFREY ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; ARSENIC TRIOXIDE; CADMIUM SULFIDE; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0287_bf7c6b53-3f07-41d5-a71a-dd97e360e4f3 44911-0287 HUMAN PRESCRIPTION DRUG Menadione Phenolic Menadione LIQUID ORAL 20151026 UNAPPROVED HOMEOPATHIC Energique, Inc. MENADIONE 6 [hp_X]/mL N 20181231 44911-0288_ec8339b4-7127-4b65-a9a5-0b0b573021e0 44911-0288 HUMAN OTC DRUG Prostex HP Baryta Carbonica, Clematis Erecta, Conium Maculatum, Lycopodium Clavatum, Mercurius Corrosivus, Pulsatilla (Pratensis), Sabal Serrulata, Selenium Metallicum, Sepia, Staphysagria, Thuja Occidentalis LIQUID ORAL 20151028 UNAPPROVED HOMEOPATHIC Energique, Inc. BARIUM CARBONATE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; PULSATILLA PRATENSIS; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0289_d8bcd16c-7c7c-4ed8-9965-a93434f91904 44911-0289 HUMAN OTC DRUG Addastat Trifolium Pratense, Petroleum, Phytolacca Decandra, Arsenicum Album, Chelidonium Majus, Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Nitricum Acidum LIQUID ORAL 20151028 UNAPPROVED HOMEOPATHIC Energique, Inc. TRIFOLIUM PRATENSE FLOWER; KEROSENE; PHYTOLACCA AMERICANA ROOT; ARSENIC TRIOXIDE; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; NITRIC ACID 3; 6; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0290_eae6c79f-649a-461c-9f80-ef96c89d89a0 44911-0290 HUMAN OTC DRUG V HP Arsenicum Album, Belladonna, Carcinosin, Echinacea (Angustifolia), Eupatorium Perfoliatum, Gelsemium Sempervirens, Lycopodium Clavatum, Phosphoricum Acidum, Phosphorus, Pyrogenium, Rhus Tox LIQUID ORAL 20151028 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; HUMAN BREAST TUMOR CELL; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0291_f8239caf-b60c-4c6c-a5b0-dd65b62398db 44911-0291 HUMAN OTC DRUG Cardiopar Convallaria Majalis, Adonis Vernalis, Apocynum Cannabinum, Heart (Suis), Thyroidinum (Suis), Cactus Grandiflorus, Digitalis Purpurea, Lycopus Virginicus LIQUID ORAL 20151109 20201208 UNAPPROVED HOMEOPATHIC Energique, Inc. CONVALLARIA MAJALIS; ADONIS VERNALIS; APOCYNUM CANNABINUM ROOT; PORK HEART; THYROID, PORCINE; SELENICEREUS GRANDIFLORUS STEM; DIGITALIS; LYCOPUS VIRGINICUS 3; 5; 6; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0292_48394697-c1df-4329-b978-d14ba5be4cfe 44911-0292 HUMAN OTC DRUG Lungex II Ginkgo Biloba, Colon (Suis), Lung (Suis), Pancreas Suis, Germanium Sesquioxide, Cuprum Metallicum, Manganum Metallicum, Stannum Metallicum, alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malic Acid, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Arsenicum Metallicum, Calcarea Carbonica, Aconiticum Acidum, Cis, Phosphorus LIQUID ORAL 20151110 UNAPPROVED HOMEOPATHIC Energique, Inc. GINKGO; SUS SCROFA COLON; SUS SCROFA LUNG; SUS SCROFA PANCREAS; GERMANIUM SESQUIOXIDE; COPPER; MANGANESE; TIN; OXOGLURIC ACID; CITRIC ACID MONOHYDRATE; FUMARIC ACID; MALIC ACID; PYRUVIC ACID; SUCCINIC ACID; 1,2-NAPHTHOQUINONE; ARSENIC; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACONITIC ACID; PHOSPHORUS 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0293_7af4b550-7d50-4f8c-9e16-8d178b92297f 44911-0293 HUMAN OTC DRUG Spleenex V Aralia Quinquefolia, Magnesium Gluconicum, Dihydricum, Potassium Gluconate, Ginkgo Biloba, Pancreas Suis, Spleen (Suis), Stomach (Suis), Germanium Sesquioxide, Cuprum Metallicum, Zincum Metallicum, Alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Magnesia Phosphorica, Malic Acid, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Aconiticum Acidum, Cis LIQUID ORAL 20151111 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; MAGNESIUM GLUCONATE; POTASSIUM GLUCONATE; GINKGO; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; GERMANIUM SESQUIOXIDE; COPPER; ZINC; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MALIC ACID; PYRUVIC ACID; SUCCINIC ACID; NAPHTHOQUINE; ACONITIC ACID, CIS- 3; 3; 3; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0294_35dd5cfd-6c7a-40c7-9767-79b1a0d16f2b 44911-0294 HUMAN OTC DRUG Spleenex VH Aralia Quinquefolia, Ginkgo Biloba, Pancreas Suis, Spleen (Suis), Stomach (Suis), Germanium Sesquioxide, Cobaltum Metallicum, Niccolum Metallicum, Zincum Metallicum, Alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malic Acid, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Baryta Carbonica, Phosphoricum Acidum, Aconiticum Acidum, Cis, Magnesium Gluconicum Dihydricum, Nux Vomica, Phosphorus LIQUID ORAL 20151111 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; GINKGO; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; GERMANIUM SESQUIOXIDE; COBALT; NICKEL; ZINC; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MALIC ACID; PYRUVIC ACID; SUCCINIC ACID; NAPHTHOQUINE; BARIUM CARBONATE; PHOSPHORIC ACID; ACONITIC ACID, CIS-; MAGNESIUM GLUCONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0295_807b78bf-c3ab-4382-b78c-9b353d8cf335 44911-0295 HUMAN OTC DRUG Rescue 5 Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos LIQUID ORAL 20151111 UNAPPROVED HOMEOPATHIC Energique, Inc. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0296_5a5604a9-5fa2-4187-8323-a2faa7ae79ed 44911-0296 HUMAN OTC DRUG Metabatone Aralia Racemosa, Avena Sativa, Berberis Vulgaris, Capsicum Annuum, Ginkgo Biloba, Adenosinum Triphosphoricum Dinatrum, Alpha-Ketoglutaricum Acidum, Amino Acids, Bromelain, Fel Tauri, Hyaluronidase, Pancreatinum, Papain, Pepsinum, Protease, Calcarea Carbonica, Calcarea Phosphorica, Hepar Sulphuris Calcareum, Iodium, Lycopodium Clavatum, Magnesia Carbonica, Natrum Muriaticum LIQUID ORAL 20151117 UNAPPROVED HOMEOPATHIC Energique, Inc. ARALIA RACEMOSA ROOT; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CAPSICUM; GINKGO; ADENOSINE TRIPHOSPHATE DISODIUM; OXOGLURIC ACID; AMINO ACIDS; BROMELAINS; BOS TAURUS BILE; HYALURONIDASE; PANCRELIPASE; PAPAIN; PEPSIN; BRINOLASE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFIDE; IODINE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CHLORIDE 3; 3; 3; 3; 3; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0297_05e393c6-5533-4b73-bbe0-802094770acf 44911-0297 HUMAN OTC DRUG Contact Allergy Antigens Anacardium Orientale, Graphites, Mezereum, Xerophyllum Asphodeloides, Rhus Diversiloba, Rhus Tox, Rhus Venenata, Urtica Dioica LIQUID ORAL 20151118 UNAPPROVED HOMEOPATHIC Energique, Inc. SEMECARPUS ANACARDIUM JUICE; GRAPHITE; DAPHNE MEZEREUM BARK; XEROPHYLLUM ASPHODELOIDES; TOXICODENDRON DIVERSILOBUM LEAF; TOXICODENDRON PUBESCENS LEAF; TOXICODENDRON VERNIX LEAFY TWIG; URTICA DIOICA 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0298_1261fdbd-ab7e-4ff1-8fbc-1520cd444b79 44911-0298 HUMAN OTC DRUG Occulopar Euphrasia Officinalis, Aurum Metallicum, Calcarea Fluorica, Causticum, Conium Maculatum, Magnesia Carbonica, Phosphorus, Silicea, Osmium Metallicum, Physostigma Venenosum, Thuja Occidentalis LIQUID ORAL 20151118 UNAPPROVED HOMEOPATHIC Energique, Inc. EUPHRASIA STRICTA; GOLD; CALCIUM FLUORIDE; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; MAGNESIUM CARBONATE; PHOSPHORUS; SILICON DIOXIDE; OSMIUM; PHYSOSTIGMA VENENOSUM SEED; THUJA OCCIDENTALIS LEAFY TWIG 6; 12; 12; 12; 12; 12; 12; 12; 15; 15; 16 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0299_e628af8f-003e-40bb-af25-503bf1958e81 44911-0299 HUMAN OTC DRUG Mentox HP Aurum Metallicum, Baryta Carbonica, Calcarea Carbonica, Lachesis Mutus, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Phosphorus LIQUID ORAL 20151118 UNAPPROVED HOMEOPATHIC Energique, Inc. GOLD; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0301_0ccbfc05-daa0-4cde-a726-78774b64babf 44911-0301 HUMAN OTC DRUG Acne HP Carbo Animalis, Carbo Vegetabilis, Kali Bichromicum, Kali Iodatum, Natrum Muriaticum, Pulsatilla (Pratensis), Sepia, Silicea, Sulphur, Zincum Metallicum LIQUID ORAL 20151118 UNAPPROVED HOMEOPATHIC Energique, Inc. CARBO ANIMALIS; ACTIVATED CHARCOAL; POTASSIUM DICHROMATE; POTASSIUM IODIDE; SODIUM CHLORIDE; ANEMONE PRATENSIS; SEPIA OFFICINALIS JUICE; SULFUR; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0302_dde87318-67ed-4227-8a33-6206cc08c990 44911-0302 HUMAN OTC DRUG Kidnex IV Ginkgo Biloba, Kidney (Suis), Lymph Node (Suis), Urinary Bladder (Suis), Germanium Sesquioxide, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Mercurius Vivus, Alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malic Acid, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Nux Vomica, Aconiticum Acidum, Cis-, Phosphorus LIQUID ORAL 20151124 UNAPPROVED HOMEOPATHIC Energique, Inc. GINKGO; PORK KIDNEY; SUS SCROFA LYMPH; SUS SCROFA URINARY BLADDER; GERMANIUM SESQUIOXIDE; SILVER; GOLD; COPPER; MERCURY; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MALIC ACID; PYRUVIC ACID; SUCCINIC ACID; 1,2-NAPHTHOQUINONE; STRYCHNOS NUX-VOMICA SEED; ACONITIC ACID, (Z)-; PHOSPHORUS 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0303_b8dea780-043e-4ea3-8d37-a326dfde64cd 44911-0303 HUMAN OTC DRUG Muscle/Tendon Pain and Stress Relief Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20151118 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0304_bf80a2e4-68d8-46f9-97ea-fe42f6e68525 44911-0304 HUMAN OTC DRUG Joint Pain and Stiffness Relief Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20151118 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0305_4db85c3e-ecb4-4296-af0c-eace6082459b 44911-0305 HUMAN OTC DRUG Shingles Pain and Ulceration Relief Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20151118 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0306_4c1e9afe-0381-4481-95da-9b27dbada860 44911-0306 HUMAN OTC DRUG Eczema HP Arsenicum Album, Calcarea Carbonica, Graphites, Mercurius Solubilis, Mezereum, Petroleum, Rhus Tox, Sepia, Sulphur LIQUID ORAL 20151118 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; KEROSENE; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; s/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0307_d14e7233-c223-4043-9890-beb57d696237 44911-0307 HUMAN OTC DRUG TSH Cord Thyroid Stimulating Hormone (Porcine) LIQUID ORAL 20151123 UNAPPROVED HOMEOPATHIC Energique, Inc. THYROTROPIN 8 [hp_C]/mL N 20181231 44911-0308_182bb7b6-8c20-4558-aad4-7a53c647927d 44911-0308 HUMAN OTC DRUG Endopar F Cimicifuga Racemosa, Fucus Vesiculosus, Oophorinum (Suis), Pituitaria Glandula (Suis), Thyroidinum (Suis), Graphites, Lachesis Mutus, Natrum Muriaticum, Pulsatilla (Pratensis), Sepia LIQUID ORAL 20151130 UNAPPROVED HOMEOPATHIC Energique, Inc. BLACK COHOSH; FUCUS VESICULOSUS; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE; GRAPHITE; LACHESIS MUTA VENOM; SODIUM CHLORIDE; ANEMONE PRATENSIS; SEPIA OFFICINALIS JUICE 3; 3; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0309_b1e23276-6415-4980-9a3e-f645fc5b0b39 44911-0309 HUMAN OTC DRUG Thyroid Tonic Acacia Arabica, Oleum Olea Europaea, Sesame Oil, Fucus Vesiculosus 3X, Iodium, Thyroidinum (Suis), Baryta Carbonica, Borage Oil, Calcarea Carbonica, Natrum Muriaticum, Pulsatilla (Pratensis), Hydrofluoricum Acidum LIQUID ORAL 20151201 UNAPPROVED HOMEOPATHIC Energique, Inc. ACACIA; OLIVE OIL; SESAME OIL; FUCUS VESICULOSUS; IODINE; THYROID, PORCINE; BARIUM CARBONATE; BORAGE OIL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; ANEMONE PRATENSIS; HYDROFLUORIC ACID 2; 2; 2; 3; 5; 6; 12; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0310_c4621911-f827-4a79-b9e8-08679071bfc0 44911-0310 HUMAN OTC DRUG Rescue 5 Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos LIQUID ORAL 20151204 UNAPPROVED HOMEOPATHIC Energique, Inc. CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 2; 2; 2; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0311_5f6fcade-7dae-4393-acee-e570ac2f6b50 44911-0311 HUMAN OTC DRUG Prostatone Chimaphila Umbellata, Hydrangea Arborescens, Sabal Serrulata, Clematis Erecta, Conium Maculatum, Pareira Brava, Pulsatilla (Pratensis), Thuja Occidentalis, Triticum Occidentalis, Triticum Repens, Staphysagria, Zincum Metallicum LIQUID ORAL 20151211 UNAPPROVED HOMEOPATHIC Energique, Inc. CHIMAPHILA UMBELLATA; HYDRANGEA ARBORESCENS ROOT; SAW PALMETTO; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; CHONDRODENDRON TOMENTOSUM ROOT; PULSATILLA PRATENSIS; THUJA OCCIDENTALIS LEAFY TWIG; ELYMUS REPENS ROOT; DELPHINIUM STAPHISAGRIA SEED; ZINC 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0312_f917d157-7127-4450-9877-d6ed6c42cc8e 44911-0312 HUMAN OTC DRUG Endopar Glandula Suprarenalis Suis, Oophorinum (Suis), Orchitinum (Bovine), Pituitaria Glandula (Suis), Arsenicum Album, Baryta Carbonica, Natrum Muriaticum, Phosphoricum Acidum, Pulsatilla (Pratensis) LIQUID ORAL 20151211 UNAPPROVED HOMEOPATHIC Energique, Inc. SUS SCROFA ADRENAL GLAND; SUS SCROFA OVARY; BOS TAURUS TESTICLE; SUS SCROFA PITUITARY GLAND; ARSENIC TRIOXIDE; BARIUM CARBONATE; SODIUM CHLORIDE; PHOSPHORIC ACID; PULSATILLA PRATENSIS 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0313_6f92f885-3688-4c32-bb74-c6f635653c68 44911-0313 HUMAN OTC DRUG Influenzinum 2015-2016 Influenzinum LIQUID ORAL 20151216 20210126 UNAPPROVED HOMEOPATHIC Energique, Inc. INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 200; 200; 200; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0314_054d7b8e-c0b0-46dd-8094-383b24e5587e 44911-0314 HUMAN OTC DRUG Liverex I Ginkgo Biloba, Fel Tauri, Gallbladder (Suis), Hepar Suis, Thyroidinum (Suis), Germanium Sesquioxide, alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malic Acid, Manganum Metallicum, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Arsenicum Metallicum, Sulphur, Aconitum Acidum, Cis-, Lycopodium Clavatum, Phosphorus LIQUID ORAL 20151211 UNAPPROVED HOMEOPATHIC Energique, Inc. GINKGO; BOS TAURUS BILE; SUS SCROFA GALLBLADDER; PORK LIVER; THYROID, PORCINE; GERMANIUM SESQUIOXIDE; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MALIC ACID; MANGANESE; PYRUVIC ACID; SUCCINIC ACID; 1,2-NAPHTHOQUINONE; ARSENIC; SULFUR; ACONITIC ACID, (Z)-; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0315_9c1d107d-c5f2-49a5-bdec-4af99de5e2f1 44911-0315 HUMAN OTC DRUG Genstat Aesculus Hippocastanum, Equisetum Hyemale, Fumaria Officinalis, Hydrocotyle Asiatica, Oleum Olea Europaea, Ononis Spinosa, Passiflora Incarnata, Robes Nigrum, Solidago Virgaurea LIQUID ORAL 20160428 20210525 UNAPPROVED HOMEOPATHIC Energique, Inc. HORSE CHESTNUT; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; CENTELLA ASIATICA; OLIVE OIL; ONONIS SPINOSA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; BLACK CURRANT; SOLIDAGO VIRGAUREA FLOWERING TOP 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0316_9cde8aed-6fbd-4b54-8643-8f24844761f7 44911-0316 HUMAN OTC DRUG Vaccistat Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Antimonium Tartaricum, Mezereum, Mercurius Solubilis, Silicea, Thuja Occidentalis, Malandrinum, Variolinum LIQUID ORAL 20160105 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; ANTIMONY POTASSIUM TARTRATE; DAPHNE MEZEREUM BARK; MERCURIUS SOLUBILIS; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; VACCINIA VIRUS; VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 3; 3; 3; 12; 12; 30; 30; 30; 60; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 44911-0317_4a19c668-1c6a-4b11-aba0-97b491c3d846 44911-0317 HUMAN OTC DRUG Cerebrapar Baptisia Tinctoria, Cerebrum Suis, Secale Cornutum, Baryta Carbonica, Calcarea Carbonica, Gelsemium Sempervirens, Kali Phosphoricum, Lycopodium Clavatum, Staphysagria LIQUID ORAL 20160111 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; SUS SCROFA CEREBRUM; CLAVICEPS PURPUREA SCLEROTIUM; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; DELPHINIUM STAPHISAGRIA SEED 3; 6; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0318_3b7274c7-a10e-48c9-8936-97234fee002a 44911-0318 HUMAN OTC DRUG Tobaccostat Avena Sativa, Valeriana Officinalis, Capsicum Annuum, Paullinia Sorbilis, Tabacum, Lobelia Inflata, Cadmium Sulphuratum, Caladium Seguinum, Daphne Indica, Nux Vomica, Phosphoricum Acidum, Spigelia Anthelmia, Staphysagria LIQUID ORAL 20160112 UNAPPROVED HOMEOPATHIC Energique, Inc. AVENA SATIVA FLOWERING TOP; VALERIAN; CAPSICUM; PAULLINIA CUPANA SEED; TOBACCO LEAF; LOBELIA INFLATA; CADMIUM SULFIDE; DIEFFENBACHIA SEGUINE; DAPHNE ODORA BARK; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; SPIGELIA ANTHELMIA; DELPHINIUM STAPHISAGRIA SEED 1; 1; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0319_6396d704-ca8f-4e81-8da5-ae443fb8d538 44911-0319 HUMAN OTC DRUG Cough HP Arsenicum Album, Bryonia (Alba), Corallium Rubrum, Drosera (Rotundifolia), Ipecacuanha, Kali Carbonicum, Phosphorus, Pulsatilla (Pratensis), Spongia Tosta LIQUID ORAL 20160112 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CORALLIUM RUBRUM EXOSKELETON; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA PRATENSIS; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0320_73154132-293d-49e3-9f1d-e391c7ac253c 44911-0320 HUMAN OTC DRUG Hemotone Urtica Urens, Ferrum Metallicum, Aranea Diadema, Arsenicum Album, Indium Metallicum, Lachesis Mutus, Natrum Muriaticum, Phosphorus LIQUID ORAL 20160112 UNAPPROVED HOMEOPATHIC Energique, Inc. URTICA URENS; IRON; ARANEUS DIADEMATUS; ARSENIC TRIOXIDE; INDIUM; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS 2; 8; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0321_6a26c863-5b77-439b-9f84-1f2e9934991d 44911-0321 HUMAN OTC DRUG Limbex Aloe, Apis Mellifica, Cerebrum Suis, Pineal Gland (Suis), Pituitaria Glandula (Suis), Hypothalamus (Suis), Apiolum LIQUID ORAL 20160113 UNAPPROVED HOMEOPATHIC Energique, Inc. ALOE; APIS MELLIFERA; SUS SCROFA CEREBRUM; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; APIOLE (PARSLEY) 3; 3; 6; 6; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0322_1fe2fb5a-d9ed-49b5-9e3b-24958a0d29d8 44911-0322 HUMAN OTC DRUG Osteotone Symphytum Officinale, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Causticum, Hekla Lava, Rhus Tox, Silicea LIQUID ORAL 20160201 UNAPPROVED HOMEOPATHIC Energique, Inc. COMFREY ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; HEKLA LAVA; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0323_8ce6d230-9a86-4605-b1f5-2302227cc06e 44911-0323 HUMAN OTC DRUG Intestipar Gentiana Lutea, Arsenicum Album, Cinchona Officinalis, Colocynthis, Nux Vomica, Phosphorus, Small Intestine (Suis) LIQUID ORAL 20160212 UNAPPROVED HOMEOPATHIC Energique, Inc. GENTIANA LUTEA ROOT; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PORK INTESTINE 3; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0324_0c764b83-f342-46f8-9616-73b70bf36471 44911-0324 HUMAN OTC DRUG Flower Antigens Arsenicum Album, Lycopodium Clavatum, Pulsatilla (Pratensis), Bellis Perennis, Calendula Officinalis, Camellia Japonica, Chrysanthemum Coronarium, Chrysanthemum Leucanthemum, Convallaria Majalis, Gardenia Jasminoides, Impatiens Glandulifera, Flos, Iris Tenax, Lilium Tigrinum, Narcissus Pseudo-Narcissus, Rosa Damascena, Syringa Vulgaris LIQUID ORAL 20160708 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; ANEMONE PRATENSIS; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; CAMELLIA JAPONICA FLOWER; GLEBIONIS CORONARIA WHOLE; LEUCANTHEMUM VULGARE; CONVALLARIA MAJALIS; GARDENIA JASMINOIDES FLOWER; IMPATIENS GLANDULIFERA FLOWER; IRIS TENAX; LILIUM LANCIFOLIUM WHOLE FLOWERING; NARCISSUS PSEUDONARCISSUS FLOWER; ROSA DAMASCENA FLOWERING TOP; SYRINGA VULGARIS FLOWER 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0325_1e11fda5-3bd5-46ed-b1bb-1a50609b626a 44911-0325 HUMAN OTC DRUG Teething HP Belladonna, Borax, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Passiflora Incarnata, Podophyllum Peltatum, Silicea LIQUID ORAL 20160223 UNAPPROVED HOMEOPATHIC Energique, Inc. ATROPA BELLADONNA; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; PODOPHYLLUM; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0326_f06be5bc-2a23-4cf5-8279-cb5952d299ea 44911-0326 HUMAN OTC DRUG Ovapar Angelica Archangelica, Caulophyllum Thalictroides, Xanthoxylum Fraxineum, Oophorinum (Suis), Apis Mellifica, Belladonna, Lachesis Mutus, Magnesia Phosphorica, Sepia, Murex Purpurea LIQUID ORAL 20160322 UNAPPROVED HOMEOPATHIC Energique, Inc. ANGELICA ARCHANGELICA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; ZANTHOXYLUM AMERICANUM BARK; SUS SCROFA OVARY; APIS MELLIFERA; ATROPA BELLADONNA; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE 3; 3; 3; 6; 12; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0327_adbb81fd-c775-4bb9-b030-97435973ee19 44911-0327 HUMAN OTC DRUG Crisis Comfort Fringed Violet, Flos, Grey Spider Flower, Flos, Sundew, Flos, Waratah, Flos LIQUID ORAL 20170327 UNAPPROVED HOMEOPATHIC Energique, Inc. THYSANOTUS TUBEROSUS FLOWER; GREVILLEA BUXIFOLIA FLOWER; DROSERA ROTUNDIFOLIA FLOWERING TOP; TELOPEA SPECIOSISSIMA FLOWER 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0328_25e4f314-27bc-44eb-8561-c20f274d1c31 44911-0328 HUMAN OTC DRUG Crisis Comfort Fringed Violet, Flos, Grey Spider Flower, Flos, Sundew, Flos, Waratah, Flos LIQUID ORAL 20160907 UNAPPROVED HOMEOPATHIC Energique, Inc. THYSANOTUS TUBEROSUS FLOWER; GREVILLEA BUXIFOLIA FLOWER; DROSERA ROTUNDIFOLIA FLOWERING TOP; TELOPEA SPECIOSISSIMA FLOWER 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0329_c7a2bd3e-4f19-482b-bb88-30f9cab8be47 44911-0329 HUMAN OTC DRUG Crisis Comfort Fringed Violet, Flos, Grey Spider Flower, Flos, Sundew, Flos, Waratah, Flos LIQUID ORAL 20160825 UNAPPROVED HOMEOPATHIC Energique, Inc. THYSANOTUS TUBEROSUS FLOWER; GREVILLEA BUXIFOLIA FLOWER; DROSERA ROTUNDIFOLIA FLOWERING TOP; TELOPEA SPECIOSISSIMA FLOWER 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20191231 44911-0330_647d40f0-52e4-44ed-8b35-74d1cf09cc79 44911-0330 HUMAN OTC DRUG Crisis Comfort Fringed Violet, Flos, Grey Spider Flower, Flos, Sundew, Flos, Waratah, Flos LIQUID ORAL 20160323 UNAPPROVED HOMEOPATHIC Energique, Inc. THYSANOTUS TUBEROSUS FLOWER; GREVILLEA BUXIFOLIA FLOWER; DROSERA ROTUNDIFOLIA FLOWERING TOP; TELOPEA SPECIOSISSIMA FLOWER 200; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0331_52d34bc5-27bc-454d-b354-2dcd04ffee56 44911-0331 HUMAN OTC DRUG Colopar Colon (Suis), Arsenicum Album, Causticum, Ignatia Amara, Lachesis Mutus, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Sepia, Silicea, Thuja Occidentalis LIQUID ORAL 20160323 UNAPPROVED HOMEOPATHIC Energique, Inc. SUS SCROFA COLON; ARSENIC TRIOXIDE; CAUSTICUM; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0332_b81053ff-2ee5-4bc2-b243-b76d6b57445a 44911-0332 HUMAN OTC DRUG Circulapar Cactus Grandiflorus, Hamamelis Virginiana, Valeriana Officinalis, Arteria Suis, Heart (Suis), Arnica Montana, Aurum Metallicum, Baryta Muriatica, Cholesterinum, Lecithin, Magnesia Muriatica, Oxalicum Acidum, Phosphorus LIQUID ORAL 20160323 UNAPPROVED HOMEOPATHIC Energique, Inc. SELENICEREUS GRANDIFLORUS STEM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; VALERIAN; SUS SCROFA ARTERY; PORK HEART; ARNICA MONTANA; GOLD; BARIUM CHLORIDE DIHYDRATE; CHOLESTEROL; EGG PHOSPHOLIPIDS; MAGNESIUM CHLORIDE; OXALIC ACID; PHOSPHORUS 3; 3; 3; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0333_ed9ce0d6-35da-40bb-8aee-bd7ea2649a39 44911-0333 HUMAN OTC DRUG Dr. Wises Special Formula 1 Uncaria Tomentosa LIQUID ORAL 20160323 UNAPPROVED HOMEOPATHIC Energique, Inc. CAT'S CLAW 6 [hp_X]/mL N 20181231 44911-0334_b4b5520a-95e4-41bf-8d4d-4bc95130db8c 44911-0334 HUMAN OTC DRUG Shingles Pain Relief Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20160323 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; a/mL N 20181231 44911-0335_e025c51b-356c-483a-8460-3c98a0adcfe7 44911-0335 HUMAN OTC DRUG Scrophularitone Baptisia Tinctoria, Echinacea (Angustifolia), Trifolium Pratense, Phytolacca Decandra, Arsenicum Iodatum, Baryta Carbonica, Bromium, Calcarea Carbonica, Kali Muriaticum, Lachesis Mutus, Mercurius Solubilis LIQUID ORAL 20160330 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; TRIFOLIUM PRATENSE FLOWER; PHYTOLACCA AMERICANA ROOT; ARSENIC TRIIODIDE; BARIUM CARBONATE; BROMINE; POTASSIUM CHLORIDE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS 3; 3; 3; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0336_d52ddab2-139f-4ee1-bcf8-eb6012ae87bf 44911-0336 HUMAN OTC DRUG Lactistat Arsenicum Album, Calcarea Carbonica, Cocculus Indicus, Graphites, Hydrofluoricum Acidum, Lachesis Mutus, Lacticum Acidum, Rhus Tox, Ruta Graveolens, Sarcolacticum Acidum, Saccharum Officinale LIQUID ORAL 20160330 UNAPPROVED HOMEOPATHIC Energique, Inc. ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANAMIRTA COCCULUS SEED; GRAPHITE; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LACTIC ACID, DL-; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SUCROSE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0337_08d6a818-3758-4a9b-b847-62fe183a6e07 44911-0337 HUMAN OTC DRUG Acnetone Berberis Vulgaris, Cimicifuga Racemosa, Antimonium Crudum, Carbo Vegetabilis, Hepar Sulphuris Calcareum, Kali Iodatum, Lycopodium Clavatum, Sepia, Sulphur LIQUID ORAL 20160330 UNAPPROVED HOMEOPATHIC Energique, Inc. BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; ANTIMONY TRISULFIDE; ACTIVATED CHARCOAL; CALCIUM SULFIDE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; SEPIA OFFICINALIS JUICE; SULFUR 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0338_e5a53e3c-ca3b-4552-b000-70c2abebb131 44911-0338 HUMAN OTC DRUG Mag Phos Magnesia Phosphorica LIQUID ORAL 20160330 UNAPPROVED HOMEOPATHIC Energique, Inc. MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 200 [hp_C]/mL N 20181231 44911-0339_e5ca1b2e-fbfd-4ab1-90c0-c07117b89e99 44911-0339 HUMAN OTC DRUG CO Q 10 Ubidecarenonum LIQUID ORAL 20160330 UNAPPROVED HOMEOPATHIC Energique, Inc. UBIDECARENONE 30 [hp_X]/mL N 20181231 44911-0340_0b27cf40-4df9-415b-91cb-c1de7259a91a 44911-0340 HUMAN OTC DRUG Calc Fluor Calcarea Fluorica LIQUID ORAL 20160331 UNAPPROVED HOMEOPATHIC Energique, Inc. CALCIUM FLUORIDE 30 [hp_C]/mL N 20181231 44911-0341_c2fc6dff-3be2-4b66-9a01-07cce4468070 44911-0341 HUMAN OTC DRUG Silicea Silicea LIQUID ORAL 20160414 UNAPPROVED HOMEOPATHIC Energique, Inc. SILICON DIOXIDE 12 [hp_X]/mL N 20181231 44911-0342_c7181002-9205-4be0-b2a8-8bfa80b02b9f 44911-0342 HUMAN OTC DRUG Cosmestat Alfalfa, Avena Sativa, Iodium, Manganum Aceticum, Hypophysis Suis, Natrum Muriaticum, Petroleum, Pulsatilla (Pratensis), Rhus Tox, Terebinthina, Thyroidinum (Bovine), Cortisone Aceticum LIQUID ORAL 20160428 UNAPPROVED HOMEOPATHIC Energique, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; IODINE; MANGANESE ACETATE; SUS SCROFA PITUITARY GLAND; SODIUM CHLORIDE; KEROSENE; ANEMONE PRATENSIS; TOXICODENDRON PUBESCENS LEAF; TURPENTINE OIL; THYROID, BOVINE; CORTISONE ACETATE 3; 3; 6; 8; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0343_bf2e5d48-ef77-4a75-b379-c10a818755f9 44911-0343 HUMAN OTC DRUG China 30C Cinchona Officinalis LIQUID ORAL 20160331 UNAPPROVED HOMEOPATHIC Energique, Inc. CINCHONA OFFICINALIS BARK 30 [hp_C]/mL N 20181231 44911-0344_d5192162-8b03-492e-aa4c-ee411f89f7de 44911-0344 HUMAN OTC DRUG Hypericum Hypericum Perforatum LIQUID ORAL 20160412 UNAPPROVED HOMEOPATHIC Energique, Inc HYPERICUM PERFORATUM 200 [hp_C]/mL N 20181231 44911-0345_ce625508-06ca-42c1-bb47-dcbd66a75352 44911-0345 HUMAN OTC DRUG Zinc Met Zincum Metallicum LIQUID ORAL 20160414 UNAPPROVED HOMEOPATHIC Energique, Inc. ZINC 200 [hp_C]/mL N 20181231 44911-0346_ae3068aa-5fd5-4de5-a325-5e83690e77e5 44911-0346 HUMAN OTC DRUG Lycopodium Lycopodium Clavatum LIQUID ORAL 20160412 UNAPPROVED HOMEOPATHIC Energique, Inc. LYCOPODIUM CLAVATUM SPORE 200 [hp_C]/mL N 20181231 44911-0347_f93e101f-3e91-4f0d-a1ca-286034d37dfb 44911-0347 HUMAN OTC DRUG Psychypar Cerebrum Suis, Baryta Carbonica, Calcarea Carbonica, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Pulsatilla (Pratensis), Sepia, Silicea LIQUID ORAL 20160419 UNAPPROVED HOMEOPATHIC Energique, Inc. SUS SCROFA CEREBRUM; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; ANEMONE PRATENSIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0348_2fbab6bd-ce52-4225-bcb2-cf1f76fa8f1b 44911-0348 HUMAN OTC DRUG Septastat Baptisia Tinctoria, Echinacea (Angustifolia), Anthracinum, Arsenicum Album, Belladonna, Crotalus Horridus, Lachesis Mutus, Ledum Palustre, Pyrogenium, Stramonium, Tarentula Cubensis LIQUID ORAL 20160414 20210721 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CROTALUS HORRIDUS HORRIDUS VENOM; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; RANCID BEEF; DATURA STRAMONIUM; CITHARACANTHUS SPINICRUS 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0349_32e82136-c3d0-4baf-868d-ac7c41b1a6d3 44911-0349 HUMAN OTC DRUG Apizastat Avena Sativa, Beta Vulgaris, Alfalfa, Chelidonium Majus, Oxalis Acetosella, Paloondo, Phytolacca Decandra, Urtica Dioica, Verbascum Thapsus, Viscum Album, Argentum Metallicum, Calcarea Fluorica, Thuja Occidentalis, Thymolum, Anthracinum, Baptisia Tinctoria, Paronichia Illecebrum, X-Ray LIQUID ORAL 20160414 UNAPPROVED HOMEOPATHIC Energique, Inc. AVENA SATIVA FLOWERING TOP; BETA VULGARIS; ALFALFA; CHELIDONIUM MAJUS; OXALIS ACETOSELLA LEAF; LARREA TRIDENTATA LEAF; PHYTOLACCA AMERICANA ROOT; URTICA DIOICA; VERBASCUM THAPSUS; VISCUM ALBUM FRUITING TOP; SILVER; CALCIUM FLUORIDE; THUJA OCCIDENTALIS LEAFY TWIG; THYMOL; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BAPTISIA TINCTORIA ROOT; ALTERNANTHERA SESSILIS; ALCOHOL, X-RAY EXPOSED (1000 RAD) 1; 1; 2; 2; 2; 2; 2; 2; 2; 2; 6; 6; 6; 7; 12; 12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0350_680d3948-2780-4fa8-84f8-cc1ee1ffb481 44911-0350 HUMAN OTC DRUG Nightshade Antigens Capsicum Annuum, Lycopersicum Esculentum, Solanum Melongena, Solanum Tuberosum, Tabacum, Alumina, Arsenicum Album, Nux Vomica, Phosphorus, Pulsatilla (Pratensis) LIQUID ORAL 20160419 UNAPPROVED HOMEOPATHIC Energique, Inc. CAPSICUM; SOLANUM LYCOPERSICUM; EGGPLANT; SOLANUM TUBEROSUM; TOBACCO LEAF; ALUMINUM OXIDE; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE PULSATILLA 9; 9; 9; 9; 9; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0351_2ee2c5c2-ac9c-4a43-ba94-ce26c8c3ee1c 44911-0351 HUMAN OTC DRUG Heartex Spongia Tosta, Ginkgo Biloba, Digitalis Purpurea, Aconitum Napellus, Heart (Suis), Kidney (Suis), Small Intestine (Suis), Germanium Sesquioxide, Cobaltum Metallicum, Manganum Metallicum, Alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malicum Acidum, Naphthochinonum, Natrum Pyruvicum, Succinicum Acidum, Arsenicum Metallicum, Aurum Metallicum, Aconiticum Acidum Cis, Cactus Grandiflorus, Phosphorus LIQUID ORAL 20160412 UNAPPROVED HOMEOPATHIC Energique, Inc. SPONGIA OFFICINALIS SKELETON, ROASTED; GINKGO; DIGITALIS; ACONITUM NAPELLUS; PORK HEART; PORK KIDNEY; PORK INTESTINE; GERMANIUM SESQUIOXIDE; COBALT; MANGANESE; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MALIC ACID; 1,4-NAPHTHOQUINONE; SODIUM PYRUVATE; SUCCINIC ACID; ARSENIC; GOLD; ACONITIC ACID, (Z)-; SELENICEREUS GRANDIFLORUS STEM; PHOSPHORUS 3; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0352_c72aa8a0-9edb-48fe-9874-ee07a54808a1 44911-0352 HUMAN OTC DRUG Erogetone Aralia Quinquefolia, Berberis Vulgaris, Causticum, Graphites, Lachesis Mutus, Natrum Muriaticum, Phosphoricum Acidum, Phosphorus, Sepia LIQUID ORAL 20160414 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; BERBERIS VULGARIS ROOT BARK; CAUSTICUM; GRAPHITE; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORIC ACID; PHOSPHORUS; SEPIA OFFICINALIS JUICE 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0353_409ff4bb-3545-4abd-a2be-703110a59832 44911-0353 HUMAN OTC DRUG Mag Phos Magnesia Phosphorica LIQUID ORAL 20160420 UNAPPROVED HOMEOPATHIC Energique, Inc. MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 30 [hp_C]/30mL N 20181231 44911-0354_0abed208-fc23-4784-b180-538894ed351d 44911-0354 HUMAN OTC DRUG Kali Sulph Kali Sulphuricum LIQUID ORAL 20160414 UNAPPROVED HOMEOPATHIC Energique, Inc. POTASSIUM SULFATE 30 [hp_C]/mL N 20181231 44911-0355_3fa27354-5a54-49ce-9e39-261d2bae83e6 44911-0355 HUMAN OTC DRUG Allerphenex II Acetylcholine Chloride, Acetaldehyde, Adrenalinum, Caffeic Acid, Candida Albicans, Chlorogenic Acid, Cinnamic Acid, Coumarinum, Cysteinum, Gallicum Acidum, Hepar Suis, Histaminum Hydrochloricum, Indolum, Malvin, Mannan, Menadione, Norepinephrine, Octopamine (Hydrochloride), Pancreas Suis, Phenyl Isothiocyanate, Phloridzinum, Quercetin, Salsolinol, Serotonin (Hydrochloride) LIQUID ORAL 20160420 UNAPPROVED HOMEOPATHIC Energique, Inc. ACETYLCHOLINE CHLORIDE; ACETALDEHYDE; EPINEPHRINE; CAFFEIC ACID; CANDIDA ALBICANS; CHLOROGENIC ACID; CINNAMIC ACID; COUMARIN; CYSTEINE; GALLIC ACID MONOHYDRATE; PORK LIVER; HISTAMINE DIHYDROCHLORIDE; INDOLE; MALVIN; YEAST MANNAN; MENADIONE; NOREPINEPHRINE; OCTOPAMINE HYDROCHLORIDE; SUS SCROFA PANCREAS; PHENYL ISOTHIOCYANATE; PHLORIZIN; QUERCETIN; SALSOLINOL HYDROCHLORIDE; SEROTONIN HYDROCHLORIDE 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0356_3f89e305-a789-4314-8edb-6b52bd781409 44911-0356 HUMAN OTC DRUG Androstat Echinacea (Angustifolia), Sabal Serrulata, Clematis Erecta, Hepar Sulphuris Calcareum, Kali Bichromicum, Pulsatilla (Pratensis), Staphysagria, Triticum Repens, Zincum Metallicum, Mercurius Solubilis, Thuja Occidentalis. LIQUID ORAL 20160413 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; SAW PALMETTO; CLEMATIS RECTA FLOWERING TOP; CALCIUM SULFIDE; POTASSIUM DICHROMATE; ANEMONE PRATENSIS; DELPHINIUM STAPHISAGRIA SEED; ELYMUS REPENS ROOT; ZINC; MERCURIUS SOLUBILIS; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 12; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0357_f4d12dde-ed4c-4ec4-9941-a1a18362aae3 44911-0357 HUMAN OTC DRUG Sycosis Miasm Nitricum Acidum, Lycopodium Clavatum, Causticum, Natrum Sulphuricum, Thuja Occidentalis LIQUID ORAL 20160413 UNAPPROVED HOMEOPATHIC Energique, Inc. NITRIC ACID; LYCOPODIUM CLAVATUM SPORE; CAUSTICUM; SODIUM SULFATE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0358_8f195de7-821e-466d-8e85-f6972bae0710 44911-0358 HUMAN OTC DRUG Lipostat Capsicum Annuum, Fucus Vesiculosus, Borage Officinalis, Lecithin, Calcarea Carbonica, Ferrum Metallicum, Kali Bichromicum, Kali Carbonica, Pulsatilla (Pratensis), Sulphur LIQUID ORAL 20160506 UNAPPROVED HOMEOPATHIC Energique, Inc. CAPSICUM; FUCUS VESICULOSUS; BORAGE; EGG PHOSPHOLIPIDS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IRON; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; ANEMONE PRATENSIS; SULFUR 3; 3; 6; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0359_8aebae68-e3b7-45f3-bb44-9ccb0ebb8588 44911-0359 HUMAN OTC DRUG Chemstat Glycerinum, Phytolacca Decandra, Taraxacum Officinale, Arsenicum Album, Nitricum Acidum, Nux Vomica, Petroleum, Phosphoricum Acidum, Phosphorus, Acetylsalicylicum Acidum, Glonoinum, Insulinum (Suis), Lithium Carbonicum, Thyroidinum (Suis), Salicylicum Acidum, Adrenocorticotrophin, Cortisone Aceticum, Eugenol, Stearyl Alcohol, Xylitol, Folliculinum, Benzoicum Acidum, Chlorinum, Potassium Sorbate, Sorbitol, Resorcinum, Benzyl Alcohol, Lacticum Acidum, Isopropyl Palmitate, Boricum Acidum, Aceticum Acidum, LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Energique, Inc. GLYCERIN; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; ARSENIC TRIOXIDE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORIC ACID; PHOSPHORUS; ASPIRIN; NITROGLYCERIN; INSULIN PORK; LITHIUM CARBONATE; SUS SCROFA THYROID; SALICYLIC ACID; CORTICOTROPIN; CORTISONE ACETATE; EUGENOL; STEARYL ALCOHOL; XYLITOL; ESTRONE; BENZOIC ACID; CHLORINE; POTASSIUM SORBATE; SORBITOL; RESORCINOL; BENZYL ALCOHOL; LACTIC ACID, DL-; ISOPROPYL PALMITATE; BORIC ACID; ACETIC ACID; PHENYLBUTAZONE; PETROLATUM; LEAD 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0360_f9a7dee5-b976-4fea-9255-fbf696d312dc 44911-0360 HUMAN OTC DRUG Organdrainex Allium Cepa, Allium Sativum, Aloe, Ambrosia Artemisiaefolia, Berberis Vulgaris, Chelidonium Majus, Collinsonia Canadensis, Cynara Scolymus, Methylcobalamin, Petroselinum Sativum, Trifolium Pratense, Alpha-Lipoicum Acidum, Palladium Metallicum LIQUID ORAL 20160614 UNAPPROVED HOMEOPATHIC Energique, Inc. ONION; ALLIUM SATIVUM WHOLE; ALOE; AMBROSIA ARTEMISIIFOLIA; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; CYNARA SCOLYMUS LEAF; METHYLCOBALAMIN; PETROSELINUM CRISPUM; TRIFOLIUM PRATENSE FLOWER; THIOCTIC ACID; PALLADIUM 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 3; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0361_2f26d30b-2a3b-4302-bc5a-8a8f712e1466 44911-0361 HUMAN OTC DRUG Vegetable Antigens Allium Cepa, Allium Sativum, Apium Graveolens, Beta Vulgaris, Brassica Oleracea Var. Botrytis, Brassica Oleracea Var. Capitata, Brassica Oleracea Var. Italica, Brassica Oleracea Var. Sabellica, Brassica Rapa Var. Rapa, Cicer Arietinum, Cucumis Staivus, Glycine Max, Lactuca Sativa, Lens Culinaris, Pastinaca Sativa, Phaseolus, Phaseolus Lunatus, Phaseolus Vulgaris, Raphanus Sativus, Spinacia Oleracea, Arsenicum Album, Bryonia (Alba), Helleborus Niger, Lycopodium Clavatum, Petroleum LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Energique, Inc. ONION; GARLIC; CELERY SEED; BEET; CAULIFLOWER; CABBAGE; BROCCOLI; KALE; TURNIP; CHICKPEA; CUCUMBER; SOYBEAN; LETTUCE; LENTIL; PARSNIP; KIDNEY BEAN; LIMA BEAN; STRING BEAN; RADISH; SPINACH; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; KEROSENE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0362_4a346da4-372e-46c9-a75b-185e83ca5959 44911-0362 HUMAN OTC DRUG Lyme HP Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Borrelia Burgdorferi Nosode, Encephalitis Nosode, Meningococcus Nosode, Hepatitis B Nosode, Arsenicum Album, Bryonia (Alba), Chelidonium Majus, Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre, Lycopodium Clavatum, Phosphorus, Rhus Tox LIQUID ORAL 20160602 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; BORRELIA BURGDORFERI; JAPANESE ENCEPHALITIS VIRUS; NEISSERIA MENINGITIDIS; HEPATITIS B VIRUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 3; 3; 6; 12; 12; 15; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0363_aa74c2da-b8a6-434a-819e-80770965dcfb 44911-0363 HUMAN OTC DRUG Lymestat Chelidonium Majus, Echinacea (Angustifolia), Hydrastis Canadensis, Arsenicum Album, Bryonia (Alba), Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre, Lycopodium Clavatum, Phosphorus, Rhus Tox LIQUID ORAL 20160602 UNAPPROVED HOMEOPATHIC Energique, Inc. CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0364_3c5b431c-026b-49f6-b919-9e8b1adbf6fc 44911-0364 HUMAN OTC DRUG HZ Neurapain HP Echinacea (Angustifolia), Kali Phosphoricum, Sarracenia Purpurea, Arsenicum Album, Causticum, Dolichos Pruriens, Hypericum Perforatum, Mezereum, Ranunculus Bulbosus, Rhus Tox LIQUID ORAL 20160615 UNAPPROVED HOMEOPATHIC Energique, Inc ECHINACEA ANGUSTIFOLIA; POTASSIUM PHOSPHATE, DIBASIC; SARRACENIA PURPUREA; ARSENIC TRIOXIDE; CAUSTICUM; MUCUNA PRURIENS FRUIT TRICHOME; HYPERICUM PERFORATUM; DAPHNE MEZEREUM BARK; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 6; 6; 9; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0365_2e53e3f0-bf29-49c2-a4c1-6bef3ea3dc82 44911-0365 HUMAN OTC DRUG Trauma Plus Gel Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum, Calcarea Fluorica, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Natrum Sulphuricum GEL TOPICAL 20160615 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; HYPERICUM PERFORATUM; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; SULFURIC ACID; CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE 1; 1; 1; 6; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g N 20181231 44911-0366_bbd81280-46fe-45d6-9fb3-4775c97b01a2 44911-0366 HUMAN OTC DRUG Psoriasis Hydrocotyle Asiatica, Lappa Major, Arsenicum Album Arsenicum Iodatum, Borax, Graphites, Mezereum, Natrum Muriaticum, Petroleum, Phytolacca Decandra, Sepia, Kali Arsenicosum GEL TOPICAL 20160616 UNAPPROVED HOMEOPATHIC Energique, Inc. CENTELLA ASIATICA; ARCTIUM LAPPA ROOT; ARSENIC ACID; ARSENIC TRIOXIDE; SODIUM BORATE; GRAPHITE; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; PETROLATUM; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; POTASSIUM ARSENITE ANHYDROUS 1; 1; 12; 12; 12; 12; 12; 12; 12; 12; 12; 16 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 44911-0367_f6fa00bc-c95a-4c1e-be28-51596842b112 44911-0367 HUMAN OTC DRUG Osteopar Equisetum Hyemale, Symphytum Officinale, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Medulla Ossis Suis, Ossa Sepia, Silicea, Hekla Lava LIQUID ORAL 20160616 UNAPPROVED HOMEOPATHIC Energique, Inc. EQUISETUM HYEMALE; COMFREY ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA BONE MARROW; SEPIA ESCULENTA BONE; SILICON DIOXIDE; HEKLA LAVA 3; 6; 12; 12; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0368_a27f1763-be96-43b8-b157-e6f661e63c79 44911-0368 HUMAN OTC DRUG Anpituapar Adrenocorticotrophin, Agnus Castus, Baryta Carbonica, Calcarea Carbonica, Iodium, Natrum Muriaticum, Phosphoricum Acidum, Sepia, Thyroidinum (Suis), Lac Caninum LIQUID ORAL 20160616 UNAPPROVED HOMEOPATHIC Energique, Inc. CORTICOTROPIN; CHASTE TREE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; SODIUM CHLORIDE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SUS SCROFA THYROID; CANIS LUPUS FAMILIARIS MILK 6; 12; 12; 12; 12; 12; 12; 12; 12; 16 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0369_751df3f9-2bb4-4509-9cf5-087389fd57d6 44911-0369 HUMAN OTC DRUG Rheumatone Cimicifuga Racemosa, Lappa Major, Trifolium Pratense, Colchicum Autumnale, Dulcamara, Lycopodium Clavatum, Pulsatilla (Pratensis), Rhododendron Chrysanthum, Rhus Tox LIQUID ORAL 20160616 UNAPPROVED HOMEOPATHIC Energique, Inc. BLACK COHOSH; ARCTIUM LAPPA ROOT; TRIFOLIUM PRATENSE FLOWER; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PRATENSIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0370_ed817356-0402-43d1-b596-faacadc1d4d7 44911-0370 HUMAN OTC DRUG Parathyropar Symphytum Officinale, Baryta Carbonica, Calcarea Carbonica, Calcarea Phosphorica, Hekla Lava, Manganum Metallicum, Rhus Tox, Silicea, Parathormonum LIQUID ORAL 20160616 UNAPPROVED HOMEOPATHIC Energique, Inc. COMFREY ROOT; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; HEKLA LAVA; MANGANESE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; PARATHYROID HORMONE 6; 12; 12; 12; 12; 12; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 44911-0371_983e2e66-9a1a-450e-94e5-ac65da6cbb3d 44911-0371 HUMAN OTC DRUG HZ Stat Astragalus Membranaceus, Echinacea (Angustifolia), Hypericum Perforatum, Hydrastis Canadensis, Dulcamara, Gelsemium Sempervirens, Nitricum Acidum, Ranunculus Bulbosus, Thuja Occidentalis LIQUID ORAL 20160616 UNAPPROVED HOMEOPATHIC Energique, Inc. ASTRAGALUS PROPINQUUS ROOT; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; GOLDENSEAL; SOLANUM DULCAMARA TOP; GELSEMIUM SEMPERVIRENS ROOT; NITRIC ACID; RANUNCULUS BULBOSUS; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0372_971129fb-c067-4714-9e6c-864d068a50a1 44911-0372 HUMAN OTC DRUG Phloridzin Phenolic Phloridzinum LIQUID ORAL 20170328 UNAPPROVED HOMEOPATHIC Energique, Inc. PHLORIZIN 6 [hp_X]/mL N 20181231 44911-0373_9267e225-8acc-4de3-89cb-b64e60583bf5 44911-0373 HUMAN OTC DRUG Thyroxine Cord Levothyroxinum LIQUID ORAL 20160621 UNAPPROVED HOMEOPATHIC Energique, Inc. LEVOTHYROXINE 12 [hp_X]/mL N 20181231 44911-0374_0698a420-8607-43b0-b63f-218e4b72d50e 44911-0374 HUMAN OTC DRUG Pneumopar Lobelia Inflata, Lung (Suis), Symphytum Officinale, Arsenicum Album, Blatta Orientalis, Bryonia (Alba), Phosphorus, Silicea, Sulphur LIQUID ORAL 20160726 UNAPPROVED HOMEOPATHIC Energique, Inc. LOBELIA INFLATA; SUS SCROFA LUNG; COMFREY ROOT; ARSENIC TRIOXIDE; BLATTA ORIENTALIS; BRYONIA ALBA ROOT; PHOSPHORUS; SILICON DIOXIDE; SULFUR 3; 6; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0375_84d154da-706d-4136-bf0a-1d9ea6a6a93a 44911-0375 HUMAN OTC DRUG Calc Sulph Calcarea Sulphurica LIQUID ORAL 20160719 UNAPPROVED HOMEOPATHIC Energique, Inc. CALCIUM SULFATE ANHYDROUS 30 [hp_X]/mL N 20181231 44911-0376_77b5f528-8a5f-4e99-ac64-9eef265d5f63 44911-0376 HUMAN OTC DRUG Bio-Immune Chelidonium Majus, Lobelia Inflata, Rumex Crispus, Sambucus Nigra, Scrophularia Nodosa, Senega Officinalis, Spongia Tosta, Taraxacum Officinale, Myristica Sebifera, Sticta Pulmonaria, Sulphur, Ustilago Maidis, Polyporus Officinalis, Candida Albicans, Carduus Marianus, Crotalus Horridus, Agaricus Muscarius, Bovista Secale Cornutum, Anas Barbariae, Hepatis Et Cordis Extractum, Anthracinum, Arsenicum Album, Baptisia Tinctoria, Berberis Vulgaris, Botulinum, Dysentery Bacillus, Gaertner Bacillus (Bach) LIQUID ORAL 20160901 UNAPPROVED HOMEOPATHIC Energique, Inc. CHELIDONIUM MAJUS; LOBELIA INFLATA; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SCROPHULARIA NODOSA; POLYGALA SENEGA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; TARAXACUM OFFICINALE; VIROLA SEBIFERA RESIN; LOBARIA PULMONARIA; SULFUR; USTILAGO MAYDIS; LARICIFOMES OFFICINALIS FRUITING BODY; CANDIDA ALBICANS; MILK THISTLE; CROTALUS HORRIDUS HORRIDUS VENOM; AMANITA MUSCARIA FRUITING BODY; LYCOPERDON UTRIFORME FRUITING BODY; CLAVICEPS PURPUREA SCLEROTIUM; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; CLOSTRIDIUM BOTULINUM; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); VACCINIA VIRUS; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; STREPTOCOCCUS PNEUMONIAE; RANCID BEEF; VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 3; 3; 3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 8; 12; 12; 12; 10; 10; 10; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0378_837ee1f8-7967-4aef-b2ea-b244272c3b9b 44911-0378 HUMAN OTC DRUG Septastat Baptisia Tinctoria, Echinacea (Angustifolia), Anthracinum, Arsenicum Album, Belladonna, Crotalus Horridus, Hyoscyamus Niger, Lachesis Mutus, Pyrogenium, Tarentula Cubensis LIQUID ORAL 20160727 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CROTALUS HORRIDUS HORRIDUS VENOM; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; RANCID BEEF; CITHARACANTHUS SPINICRUS 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL N 20181231 44911-0379_4342f750-bc0e-44c4-93ff-38b2fa0a632d 44911-0379 HUMAN OTC DRUG Argentum Nitricum Argentum Nitricum LIQUID ORAL 20160816 UNAPPROVED HOMEOPATHIC Energique, Inc. SILVER NITRATE 200 [hp_C]/mL N 20181231 44911-0380_79b9e1c5-cbd1-4243-9aa4-bba8e41004ca 44911-0380 HUMAN OTC DRUG Aurum Met Aurum Metallicum LIQUID ORAL 20160816 UNAPPROVED HOMEOPATHIC Energique, Inc. GOLD 200 [hp_C]/mL N 20181231 44911-0381_5343ad4e-32a1-4e7f-8997-ae1d4eb0c19b 44911-0381 HUMAN OTC DRUG Belladonna Belladonna LIQUID ORAL 20160819 UNAPPROVED HOMEOPATHIC Energique, Inc. ATROPA BELLADONNA 200 [hp_C]/mL N 20181231 44911-0382_2ad4d9ad-6256-4bcf-86da-714304eb30e6 44911-0382 HUMAN OTC DRUG Bryonia Bryonia (Alba) LIQUID ORAL 20160819 UNAPPROVED HOMEOPATHIC Energique, Inc. BRYONIA ALBA ROOT 200 [hp_C]/mL N 20181231 44911-0383_f02fb08b-91a8-4173-afde-e23b5dafa647 44911-0383 HUMAN OTC DRUG Calc Carb Calcarea Carbonica LIQUID ORAL 20160822 UNAPPROVED HOMEOPATHIC Energique, Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE 200 [hp_C]/mL N 20181231 44911-0384_110f246d-b066-49f6-a4be-97c303c621c8 44911-0384 HUMAN OTC DRUG Causticum Causticum LIQUID ORAL 20160822 UNAPPROVED HOMEOPATHIC Energique, Inc. CAUSTICUM 200 [hp_C]/mL N 20181231 44911-0385_a35364b5-6390-4891-8903-dc1632b5e92c 44911-0385 HUMAN OTC DRUG Chamomilla Chamomilla LIQUID ORAL 20160822 UNAPPROVED HOMEOPATHIC Energique, Inc. MATRICARIA RECUTITA 200 [hp_C]/mL N 20181231 44911-0386_1baef387-e92a-43e2-82cc-6a46f80dcff2 44911-0386 HUMAN OTC DRUG Kali Carb Kali Carbonicum LIQUID ORAL 20160822 UNAPPROVED HOMEOPATHIC Energique, Inc. POTASSIUM CARBONATE 200 [hp_C]/mL N 20181231 44911-0387_05c8333c-fb4e-4cae-976a-eb513bd59b08 44911-0387 HUMAN OTC DRUG Trauma Plus Gel Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum, Calcarea Fluorica, Ferrum Phosphoricum, Rhus Tox, Ruta Graveolens, Natrum Sulphuricum GEL TOPICAL 20160804 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; HYPERICUM PERFORATUM; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; SULFURIC ACID; CALCIUM FLUORIDE; FERRUM PHOSPHORICUM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE 1; 1; 1; 6; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [IR]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g N 20181231 44911-0388_ea14b75d-4c77-4dee-a8bd-ef4fecb6e8f6 44911-0388 HUMAN OTC DRUG Lachesis Lachesis Mutus LIQUID ORAL 20160822 UNAPPROVED HOMEOPATHIC Energique, Inc. LACHESIS MUTA VENOM 200 [hp_C]/mL N 20181231 44911-0389_92e6fbf4-5bda-4947-9849-1d41d4f78927 44911-0389 HUMAN OTC DRUG Merc Sol Mercurius Solubilis LIQUID ORAL 20160822 UNAPPROVED HOMEOPATHIC Energique, Inc. MERCURIUS SOLUBILIS 200 [hp_C]/mL N 20181231 44911-0390_1c534f8a-5734-4652-956d-643a58517465 44911-0390 HUMAN OTC DRUG Pulsatilla Pulsatilla (Vulgaris) LIQUID ORAL 20160822 UNAPPROVED HOMEOPATHIC Energique, Inc. PULSATILLA VULGARIS 200 [hp_C]/mL N 20181231 44911-0391_d152a565-9339-412a-bb69-b65525aab3f6 44911-0391 HUMAN OTC DRUG Sepia Sepia LIQUID ORAL 20160822 UNAPPROVED HOMEOPATHIC Energique, Inc. SEPIA OFFICINALIS JUICE 200 [hp_C]/mL N 20181231 44911-0392_97e86194-53ee-47ba-b002-e3c73d7b5da9 44911-0392 HUMAN OTC DRUG Staphysagria Staphysagria LIQUID ORAL 20160823 UNAPPROVED HOMEOPATHIC Energique, Inc. DELPHINIUM STAPHISAGRIA SEED 200 [hp_C]/mL N 20181231 44911-0393_e7f58806-2d94-48e5-9dc9-abc420626153 44911-0393 HUMAN OTC DRUG Stramonium Stramonium LIQUID ORAL 20160823 UNAPPROVED HOMEOPATHIC Energique, Inc. DATURA STRAMONIUM 200 [hp_C]/mL N 20181231 44911-0394_c8d49a51-501a-402e-a0d7-da06dcb2ef64 44911-0394 HUMAN OTC DRUG Sulphur Sulphur LIQUID ORAL 20160823 UNAPPROVED HOMEOPATHIC Energique, Inc. SULFUR 200 [hp_C]/mL N 20181231 44911-0395_cab3b98c-ad48-4ce6-89ca-e64a6167a08b 44911-0395 HUMAN OTC DRUG Veratrum Alb Veratrum Album LIQUID ORAL 20160823 UNAPPROVED HOMEOPATHIC Energique, Inc. VERATRUM ALBUM ROOT 200 [hp_C]/mL N 20181231 44911-0396_77382e08-f990-4a1e-933c-4e9512a194f6 44911-0396 HUMAN OTC DRUG Septastat Baptisia Tinctoria, Echinacea (Angustifolia), Anthracinum, Arsenicum Album, Belladonna, Crotalus Horridus, Hyoscyamus Niger, Lachesis Mutus, Pyrogenium, Tarentula Cubensis LIQUID ORAL 20170328 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CROTALUS HORRIDUS HORRIDUS VENOM; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; RANCID BEEF; CITHARACANTHUS SPINICRUS 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0397_698ba521-3330-4b20-8d67-44bce6f533c6 44911-0397 HUMAN OTC DRUG Mannan Phenolic Mannan LIQUID ORAL 20170330 UNAPPROVED HOMEOPATHIC Energique, Inc. YEAST MANNAN 6 [hp_X]/mL N 20181231 44911-0398_15e48087-2c29-4eb2-abfe-1e2acb6215c9 44911-0398 HUMAN OTC DRUG Endurotone Aralia Quinquefolia, Avena Sativa, Sarsaparilla (Smilax Regelii), Agnus Castus, Damiana, Sabal Serrulata, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20161012 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; SMILAX REGELII ROOT; CHASTE TREE; TURNERA DIFFUSA LEAFY TWIG; SAW PALMETTO; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 3; 3; 3; 6; 6; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0399_b8b02fda-068b-4338-bc5c-148d8a6511fb 44911-0399 HUMAN OTC DRUG Estrogens Estradiol, Estriol, Folliculinum LIQUID ORAL 20160913 UNAPPROVED HOMEOPATHIC Energique, Inc. ESTRADIOL; ESTRIOL; ESTRONE 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0400_75ab6537-1d5e-45bb-b0b4-9c51cd83d2a0 44911-0400 HUMAN OTC DRUG Genstat Aesculus Hippocastanum, Equisetum Hyemale, Fumaria Officinalis, Hydrocotyle Asiatica, Oleum Olea Europaea, Passiflora Incarnata, Ribes Nigrum, Solidago Virgaurea, Ononis Spinosa LIQUID ORAL 20160914 UNAPPROVED HOMEOPATHIC Energique, Inc. HORSE CHESTNUT; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; CENTELLA ASIATICA; OLIVE OIL; PASSIFLORA INCARNATA FLOWERING TOP; RIBES NIGRUM LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; ONONIS SPINOSA WHOLE 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 44911-0401_dd0a93d1-4244-46e5-95bd-a2e4f3f45fcd 44911-0401 HUMAN OTC DRUG ThroatSpray Echinacea (Angustifolia), Eugenia Caryophyllata, Glycerinum, Myrrha, Salvia Officinalis, Spilanthes Oleracea, Thymus Serpyllum, Baptisia Tinctoria, Phytolacca Decandra, Hydrastis Canadensis, Apis Mellifica, Belladonna, Lachesis Mutus, Mercurius Solubilis, Hepar Sulphuris Calcareum SPRAY ORAL 20161013 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; CLOVE; GLYCERIN; MYRRH; SAGE; ACMELLA OLERACEA FLOWERING TOP; THYMUS SERPYLLUM; BAPTISIA TINCTORIA ROOT; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; APIS MELLIFERA; ATROPA BELLADONNA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; CALCIUM SULFIDE 1; 1; 1; 2; 2; 2; 2; 3; 3; 6; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0402_d20eb805-9156-43cb-bd94-6f8e6ce053be 44911-0402 HUMAN OTC DRUG Nut Antigens Almond (Nut), Cashew (Nut), Black Walnut (Nut), Pecan (Nut), Coconut, Oleum Olea Europaea, Chestnut (Nut), Water Chestnut (Nut), Pinenut (Nut), Macadamia (Nut), Pistachio (Nut), Peanut (Nut), English Walnut (Nut), Brazil Nut (Nut), Hazelnut (Nut), Arsenicum Album, Lycopodium Clavatum, Pulsatilla (Vulgaris), Sulphur, Carya Alba LIQUID ORAL 20161014 UNAPPROVED HOMEOPATHIC Energique, Inc. ALMOND; CASHEW; BLACK WALNUT; PECAN; COCONUT; OLIVE OIL; CHINESE CHESTNUT; TRAPA BICORNIS SEED; PINE NUT; MACADAMIA NUT; PISTACHIO; PEANUT; ENGLISH WALNUT; BRAZIL NUT; AMERICAN HAZELNUT; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; ANEMONE PULSATILLA; SULFUR; MOCKERNUT 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 15; 15; 15; 15; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 44911-0403_5257b5b8-23b3-42b0-b26e-f3c8368bd587 44911-0403 HUMAN OTC DRUG Influenzinum Influenzinum (2016-2017) LIQUID ORAL 20161115 UNAPPROVED HOMEOPATHIC Energique, Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0404_3e4e0840-4fcf-47f1-a049-e3f2e7093758 44911-0404 HUMAN OTC DRUG Scrophulous HP Baryta Carbonica, Bromium, Calcarea Carbonica, Ferrum Iodatum, Gnaphalium Polycephalum, Mercurius Solubilis, Phytolacca Decandra, Rhus Tox, Silicea LIQUID ORAL 20161115 UNAPPROVED HOMEOPATHIC Energique, Inc. BARIUM CARBONATE; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44911-0405_1903c016-46e0-4040-9ae1-56e308a44d01 44911-0405 HUMAN OTC DRUG Gonadal Homeopathic Capsicum Annuum, Oophorinum (Suis), Ferrum Metallicum, Lachesis Mutus, Sepia, Lac Caninum LIQUID ORAL 20161130 UNAPPROVED HOMEOPATHIC Energique, Inc. CAPSICUM; SUS SCROFA OVARY; IRON; LACHESIS MUTA VENOM; SEPIA OFFICINALIS JUICE; CANIS LUPUS FAMILIARIS MILK 6; 6; 12; 12; 12; 16 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0406_512983f6-6faf-4f5d-8c0b-801c3e7f72f9 44911-0406 HUMAN OTC DRUG Pituitary Homeopathic Capsicum Annuum, Hypophysis Suis, Baryta Carbonica, Ferrum Metallicum, Lycopodium Clavatum LIQUID ORAL 20170804 UNAPPROVED HOMEOPATHIC Energique, Inc. CAPSICUM; SUS SCROFA PITUITARY GLAND; BARIUM CARBONATE; IRON; LYCOPODIUM CLAVATUM SPORE 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0407_b0d7d76c-805f-4259-ad8e-ba30d9d486e4 44911-0407 HUMAN OTC DRUG Fungustat II Echinacea (Angustifolia), Fucus Vesiculosus, Hydrastis Canadensis, Phytolacca Decandra, Kreosotum, Natrum Muriaticum, Candida Albicans, Lycopodium Clavatum, Pulsatilla (Pratensis), Sepia LIQUID ORAL 20161122 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; FUCUS VESICULOSUS; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; WOOD CREOSOTE; SODIUM CHLORIDE; CANDIDA ALBICANS; LYCOPODIUM CLAVATUM SPORE; ANEMONE PRATENSIS; SEPIA OFFICINALIS JUICE 3; 3; 6; 6; 12; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0408_d04c6b93-f734-4e2c-b35d-4315fdb44fdb 44911-0408 HUMAN OTC DRUG Cardiopar Convallaria Majalis, Adonis Vernalis, Apocynum Cannabinum, Arteria Suis, Heart (Suis), Thyroidinum (Suis), Cactus Grandiflorus, Digitalis Purpurea, Lycopus Virginicus LIQUID ORAL 20161207 UNAPPROVED HOMEOPATHIC Energique, Inc. CONVALLARIA MAJALIS; ADONIS VERNALIS; APOCYNUM CANNABINUM ROOT; SUS SCROFA ARTERY; PORK HEART; SUS SCROFA THYROID; SELENICEREUS GRANDIFLORUS STEM; DIGITALIS; LYCOPUS VIRGINICUS 4; 5; 6; 8; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0409_f7b485c5-f2b7-49b7-9602-4cc12dbb6e34 44911-0409 HUMAN OTC DRUG Cardio Tonic Cactus Grandiflorus, L-Carnitine, Linum Usitatissimum, Strophanthus Hispidus, Borago Officinalis, Heart (Suis), Kali Carbonicum, Kali Nitricum, Thyroidinum (Suis), Adonis Vernalis, Digitalis Purpurea, Lycopus Virginicus LIQUID ORAL 20170103 UNAPPROVED HOMEOPATHIC Energique, Inc. SELENICEREUS GRANDIFLORUS STEM; LEVOCARNITINE; FLAX SEED; STROPHANTHUS HISPIDUS SEED; BORAGE; PORK HEART; POTASSIUM CARBONATE; POTASSIUM NITRATE; SUS SCROFA THYROID; ADONIS VERNALIS; DIGITALIS; LYCOPUS VIRGINICUS 3; 3; 4; 4; 6; 6; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0410_e32e83c1-25d5-4757-bdbb-2dccd74070c7 44911-0410 HUMAN OTC DRUG Infectistat Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Lobelia Inflata, Lomatium Dissectum, Phytolacca Decandra, Symphytum Officinale, Lung (Suis), Aconitum Napellus, Arsenicum Album, Belladonna, Bryonia, Causticum, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Natrum Sulphuricum, Phosphorus, Pulsatilla, Rhus Tox, Silicea, Sulphur, Pyrogenium LIQUID ORAL 20161230 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; SUS SCROFA LUNG; COMFREY ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; RANCID BEEF 3; 3; 3; 3; 3; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0411_9a10622b-ec65-491a-99b1-80a0b97e6ebe 44911-0411 HUMAN OTC DRUG Colostat Rhamnus Purshiana, Spigelia Anthelmia, Taraxacum Officinal, Cajuputum, Hydrastis Canadensis, Alumina, Cina, Cinchona Officinalis, Lycopodium Clavatum, Magnesia Phosphorica, Mandragora Officinarum, Nux Vomica LIQUID ORAL 20161230 UNAPPROVED HOMEOPATHIC Energique, Inc. FRANGULA PURSHIANA BARK; SPIGELIA ANTHELMIA; TARAXACUM OFFICINALE; CAJUPUT OIL; GOLDENSEAL; ALUMINUM OXIDE; ARTEMISIA CINA PRE-FLOWERING TOP; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANDRAGORA OFFICINARUM ROOT; STRYCHNOS NUX-VOMICA SEED 3; 3; 3; 6; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0412_8529ce9d-7494-4469-bc1c-a13ace91f23a 44911-0412 HUMAN OTC DRUG Phenylalanine Phenolic Phenylalanine LIQUID ORAL 20170105 UNAPPROVED HOMEOPATHIC Energique, Inc. PHENYLALANINE 6 [hp_X]/mL N 20181231 44911-0413_76ce04da-41c9-4bc8-b90d-18d8aa668702 44911-0413 HUMAN OTC DRUG Virustat Echinacea (Angustifolia), Lomatium Dissectum, Hydrastis Canadensis, Aconitum Napellus, Arsenicum Album, Belladonna, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lachesis Mutus, Rhus Tox, Pyrogenium LIQUID ORAL 20170109 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; GOLDENSEAL; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; TOXICODENDRON PUBESCENS LEAF; RANCID BEEF 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0414_2e63ad2b-f270-46ed-8f90-4ea04c8fa4f4 44911-0414 HUMAN OTC DRUG Lyme HP Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Borrelia Burgdorferi Nosode, Meningococcus Nosode, Encephalitis Nosode, Hepatitis B Nosode, Arsenicum Album, Bryonia (Alba), Chelidonium Majus, Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre, Lycopodium Clavatum, Phosphorus, Rhus Tox LIQUID ORAL 20170110 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; BORRELIA BURGDORFERI; NEISSERIA MENINGITIDIS; JAPANESE ENCEPHALITIS VIRUS; HEPATITIS B VIRUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 3; 3; 6; 12; 15; 18; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0415_34c154fb-3cbd-4812-89bc-4ec6b165a948 44911-0415 HUMAN OTC DRUG Recovatone Glycyrrhiza Glabra, Kali Muriaticum, Zincum Gluconicum, Kali Phosphoricum, Iodium, Phosphorus, Adrenocorticotrophin, Ascorbic Acid, Calcium Gluconate, L-Arginine, L-Carnitine, L-Ornithine, Magnesia Muriatica, Magnesium Gluconicum, Dihydricum, Manganese Gluconate, Natrum Muriaticum, Adrenalinum, Cobalt Gluconate, Copper Gluconate, Creatine, Ferrous Gluconate, Glutamine, L-Leucine, L-Valine, Potassium Gluconate, Selenium Dioxide, Boron, Calcarea Phosphorica, Chromium, Molybdenum, Niccolum Metallicum LIQUID ORAL 20170124 UNAPPROVED HOMEOPATHIC Energique, Inc. GLYCYRRHIZA GLABRA; POTASSIUM CHLORIDE; ZINC GLUCONATE; DIBASIC POTASSIUM PHOSPHATE; IODINE; PHOSPHORUS; CORTICOTROPIN HUMAN; ASCORBIC ACID; CALCIUM GLUCONATE; ARGININE; CARNITINE; ORNITHINE; MAGNESIUM CHLORIDE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; SODIUM CHLORIDE; EPINEPHRINE; COBALTOUS GLUCONATE; COPPER GLUCONATE; CREATINE; FERROUS GLUCONATE; GLUTAMINE; LEUCINE; VALINE; POTASSIUM GLUCONATE; SELENIUM DIOXIDE; BORON; TRIBASIC CALCIUM PHOSPHATE; CHROMIUM; MOLYBDENUM; NICKEL; SELENIUM; STRONTIUM CARBONATE; VANADIUM 1; 2; 2; 3; 4; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0416_7f7ca580-b28f-445f-8d0b-f614f5659f55 44911-0416 HUMAN OTC DRUG Traumatone Calendula Officinalis, Symphytum Officinale, Arnica Montana, Bellis Perennis, Hypericum Perforatum, Ledum Palustre, Phosphorus, Rhus Tox, Ruta Graveolens, Staphysagria, Strontium Carbonicum LIQUID ORAL 20170208 UNAPPROVED HOMEOPATHIC Energique, Inc. CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; STRONTIUM CARBONATE 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0417_4a022661-0d54-459b-a367-42890bd7d855 44911-0417 HUMAN OTC DRUG Grain and Seed Antigens Bamboo, Barley, Corn, Cotton Seed, Flax Seed (Linum Usitatissimum), Millet, Milo, Oat, Poppy Seed, Rice, Rye, Safflower, Sesame, Sorghum, Soy Bean, Sugarcane, Sunflower (Helianthus Annuus), Wheat, Arsenicum Album, Lycopodium Clavatum, Natrum Muriaticum, Sulphur LIQUID ORAL 20170208 UNAPPROVED HOMEOPATHIC Energique, Inc. BAMBUSA VULGARIS TOP; BARLEY; CORN; COTTON SEED; FLAX SEED; MILLET; OAT; POPPY SEED; BROWN RICE; RYE; SAFFLOWER; SESAME SEED; SORGHUM; SOYBEAN; SUGARCANE; HELIANTHUS ANNUUS FLOWERING TOP; WHEAT; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0418_3d1cf82b-47c3-4160-ad63-4cc0d68628b9 44911-0418 HUMAN OTC DRUG Coumarin Phenolic Coumarinum LIQUID ORAL 20170405 UNAPPROVED HOMEOPATHIC Energique, Inc. COUMARIN 6 [hp_X]/mL N 20181231 44911-0419_efcee114-e472-4654-8e84-f4c05d13a447 44911-0419 HUMAN OTC DRUG Liverex I Ginkgo Biloba, Fel Tauri, Gallbladder (Suis), Hepar Suis), Thyroidinum (Suis), Germanium Sesquioxide, Alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malicum Acidum, Manganum Metallicum, Pyruvic Acid, Succinicum Acidum, Naphthochinonum, Arsenicum Metallicum, Sulphur, Aconiticum Acidum, Cis, Lycopodium Clavatum, Natrum Oxalaceticum, Phosphorus LIQUID ORAL 20170228 UNAPPROVED HOMEOPATHIC Energique, Inc. GINKGO; BOS TAURUS BILE; SUS SCROFA GALLBLADDER; PORK LIVER; SUS SCROFA THYROID; GERMANIUM SESQUIOXIDE; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MALIC ACID; MANGANESE; PYRUVIC ACID; SUCCINIC ACID; 1,4-NAPHTHOQUINONE; ARSENIC; SULFUR; ACONITIC ACID, (Z)-; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; PHOSPHORUS 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0420_7871b6de-a6fb-4345-9854-f65ea27062d3 44911-0420 HUMAN OTC DRUG Pancreapar Syzygium Jambolanum, Glandula Suprarenalis Suis, Hydrastis Canadensis, Hypophysis Suis, Pancreas Suis, Phaseolus, Aceticum Acidum, Lacticum Acidum, Phosphoricum Acidum, Phosphorus, Uranium Nitricum LIQUID ORAL 20170804 UNAPPROVED HOMEOPATHIC Energique, Inc. SYZYGIUM CUMINI SEED; SUS SCROFA ADRENAL GLAND; GOLDENSEAL; SUS SCROFA PITUITARY GLAND; SUS SCROFA PANCREAS; KIDNEY BEAN; ACETIC ACID; LACTIC ACID; PHOSPHORIC ACID; PHOSPHORUS; URANYL NITRATE HEXAHYDRATE 3; 6; 6; 6; 6; 9; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0421_93f53e61-c7eb-4e6e-a9db-c6aeb28d7e83 44911-0421 HUMAN OTC DRUG Hypothalmupar Aralia Quinquefolia, Ginkgo Biloba, Hydrocotyle Asiatica, Cerebrum Suis, Hypophysis Suis, Hypothalamus (Bovine), Phosphorus, Silicea LIQUID ORAL 20170804 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; GINKGO; CENTELLA ASIATICA; SUS SCROFA CEREBRUM; SUS SCROFA PITUITARY GLAND; SUS SCROFA HYPOTHALAMUS; PHOSPHORUS; SILICON DIOXIDE 3; 3; 3; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0423_90526ab4-af7c-461d-a6fd-c9e11c1f6623 44911-0423 HUMAN OTC DRUG Phenylisothiocyanate Phenolic Phenyl Isothiocyanate LIQUID ORAL 20170502 UNAPPROVED HOMEOPATHIC Energique, Inc. PHENYL ISOTHIOCYANATE 6 [hp_X]/mL N 20181231 44911-0424_75b20b1b-6922-4e24-a8b3-eedd3fadce0c 44911-0424 HUMAN OTC DRUG EBV Stat Astragalus Membranaceus, Echinacea (Angustifolia), Hydrastis Canadensis, Phytolacca Decandra, Aranea Diadema, Iridium Metallicum, Lycopodium Clavatum, Rhus Tox, Silicea, Sepia, Epstein-Barr Virus Nosode LIQUID ORAL 20170519 UNAPPROVED HOMEOPATHIC Energique, Inc. ASTRAGALUS PROPINQUUS ROOT; ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; ARANEUS DIADEMATUS; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SEPIA OFFICINALIS JUICE; HUMAN HERPESVIRUS 4 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0425_548821f5-3bad-495d-b92c-ac08153d5fcc 44911-0425 HUMAN OTC DRUG Gastropar Gentiana Lutea, Sambucus Nigra, Stomach (Suis), Symphytum Officinale, Arsenicum Album, Bismuthum Subnitricum, Carbo Vegetabilis, Lycopodium Clavatum, Nux Vomica, Phosphorus LIQUID ORAL 20170530 UNAPPROVED HOMEOPATHIC Energique, Inc. GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; SUS SCROFA STOMACH; COMFREY ROOT; ARSENIC TRIOXIDE; BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 3; 6; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0427_0c1078ad-6d37-44d8-a9ee-ecbcfd26beb8 44911-0427 HUMAN OTC DRUG Thymupar Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Thymus (Suis), Arsenicum Album, Belladonna, Hepar Sulphuris Calcareum, Iridium Metallicum, Lachesis Mutus LIQUID ORAL 20170606 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; SUS SCROFA THYMUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; CALCIUM SULFIDE; IRIDIUM; LACHESIS MUTA VENOM 3; 3; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0428_7880862e-9655-44a1-9a42-a6fb6de6bbe9 44911-0428 HUMAN OTC DRUG Sinutone Echinacea (Angustifolia), Hydrastis Canadensis, Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Kali Bichromicum, Nux Moschata, Pulsatilla (Vulgaris), Sepia, Solidago Virgaurea LIQUID ORAL 20170609 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; ONION; AMBROSIA ARTEMISIIFOLIA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP; ARSENIC TRIOXIDE; POTASSIUM DICHROMATE; NUTMEG 3; 6; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0429_cbe3fed8-117d-4ccd-bc05-92b8439fe620 44911-0429 HUMAN OTC DRUG Spleenex V Aralia Quinquefolia, Magnesium Gluconicum Dihydricum, Potassium Gluconate, Ginkgo Biloba, Pancreas Suis, Spleen (Suis), Stomach (Suis), Germanium Sesquioxide, Cuprum Metallicum, Zincum Metallicum, Alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Magnesia Phosphorica, Malicum Acidum, Pyruvic Acid, Succinicum Acidum, Naphthochinonum, Aconiticum Acidum, Cis-, Natrum Oxalaceticum LIQUID ORAL 20170608 UNAPPROVED HOMEOPATHIC Energique, Inc. AMERICAN GINSENG; MAGNESIUM GLUCONATE; POTASSIUM GLUCONATE; GINKGO; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; GERMANIUM SESQUIOXIDE; COPPER; ZINC; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MALIC ACID; PYRUVIC ACID; SUCCINIC ACID; NAPHTHOQUINE; ACONITIC ACID, (Z)-; SODIUM DIETHYL OXALACETATE 3; 3; 3; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0430_e7a0f94d-40d5-47e9-a0bc-f9747f1cbbcb 44911-0430 HUMAN OTC DRUG Glutenstat Alfalfa, Cinchona Officinalis, Zingiber Officinale, Hydrastis Canadensis, Barley (Grain), Carbo Vegetabilis, Glyphosate, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Oat (Grain), Pulsatilla (Vulgaris), Rye (Grain), Wheat (Grain), Gluten LIQUID ORAL 20170621 UNAPPROVED HOMEOPATHIC Energique, Inc. ALFALFA; CINCHONA OFFICINALIS BARK; GINGER; GOLDENSEAL; BARLEY; ACTIVATED CHARCOAL; GLYPHOSATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; OATMEAL; ANEMONE PULSATILLA; RYE; WHEAT; WHEAT GLUTEN 4; 4; 4; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 16 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0431_392c71e5-69f9-4423-ad03-99339419070e 44911-0431 HUMAN OTC DRUG Pneumostat Echinacea (Angustifolia), Hydrastis Canadensis, Hypericum Perforatum, Symphytum Officinale, Arsenicum Album, Causticum, Kali Carbonicum, Natrum Sulphuricum, Phosphorus, Pulsatilla (Pratensis), Silicea LIQUID ORAL 20170620 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HYPERICUM PERFORATUM; COMFREY ROOT; ARSENIC TRIOXIDE; CAUSTICUM; POTASSIUM CARBONATE; SODIUM SULFATE; PHOSPHORUS; PULSATILLA PRATENSIS; SILICON DIOXIDE 3; 3; 6; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0433_91b67713-be57-4e48-ad7e-dbef2f48747a 44911-0433 HUMAN OTC DRUG Virustat Echinacea (Angustifolia), Lomatium Dissectum, Hydrastis Canadensis, Aconitum Napellus, Arsenicum Album, Belladonna, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lachesis Mutus, Rhus Tox, Pyrogenium LIQUID ORAL 20170724 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; LOMATIUM DISSECTUM ROOT; GOLDENSEAL; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; TOXICODENDRON PUBESCENS LEAF; RANCID BEEF 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0435_c525aced-2783-4566-b6e1-25095846bf82 44911-0435 HUMAN OTC DRUG Indole Phenolic Indolum LIQUID ORAL 20170801 UNAPPROVED HOMEOPATHIC Energique, Inc. INDOLE 6 [hp_X]/mL N 20181231 44911-0436_5ee16213-eb6a-40c3-8aec-0f45e4290364 44911-0436 HUMAN OTC DRUG Infectistat Baptisia Tinctoria, Echinacea (Angustifolia), Lobelia Inflata, Lomatium Dissectum, Phytolacca Decandra, Hydrastis Canadensis, Lung (Suis), Symphytum Officinale, Aconitum Napellus, Arsenicum Album, Belladonna, Bryonia (Alba), Causticum, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Natrum Sulphuricum, Phosphorus, Pulsatilla (Vulgaris), Rhus Tox, Silicea, Sulphur, Pyrogenium LIQUID ORAL 20170905 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; SUS SCROFA LUNG; COMFREY ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; RANCID BEEF 3; 3; 3; 3; 3; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0437_89753ec8-fbd4-4822-ade0-40d84102a348 44911-0437 HUMAN OTC DRUG Fungustat II Echinacea (Angustifolia), Fucus Vesiculosus, Hydrastis Canadensis, Phytolacca Decandra, Kreosotum, Natrum Muriaticum, Candida Albicans, Lycopodium Clavatum, Pulsatilla (Pratensis), Sepia LIQUID ORAL 20170905 UNAPPROVED HOMEOPATHIC Energique, Inc. ECHINACEA ANGUSTIFOLIA; FUCUS VESICULOSUS; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; WOOD CREOSOTE; SODIUM CHLORIDE; CANDIDA ALBICANS; LYCOPODIUM CLAVATUM SPORE; ANEMONE PRATENSIS; SEPIA OFFICINALIS JUICE 3; 3; 6; 6; 12; 12; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0438_f0a0f37b-0a5e-4ca1-bc0d-9d89b296083e 44911-0438 HUMAN PRESCRIPTION DRUG Lyme HP Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Borrelia Burgdorferi Nosode, Babesia Microti, Ehrlichia Nosode (Canine), Encephalitis Nosode, Meningococcus Nosode, Hepatitis B Nosode, Arsenicum Album, Bryonia (Alba), Chelidonium Majus, Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre, Lycopodium Clavatum, Phosphorus, Rhus Tox LIQUID ORAL 20170906 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; BORRELIA BURGDORFERI; BABESIA MICROTI; EHRLICHIA CANIS; JAPANESE ENCEPHALITIS VIRUS; NEISSERIA MENINGITIDIS; HEPATITIS B VIRUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 3; 3; 6; 12; 20; 20; 30; 30; 38; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0439_892cd054-2d5d-40b9-8014-25f06d899736 44911-0439 HUMAN OTC DRUG Lungex II Ginkgo Biloba, Colon (Suis), Lung (Suis), Pancreas Suis, Germanium Sesquioxide, Cuprum Metallicum, Manganum Metallicum, Stannum Metallicum, alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malic Acid, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Arsenicum Metallicum, Calcarea Carbonica, Aconiticum Acidum, Cis, Natrum Oxalaceticum, Phosphorus LIQUID ORAL 20170908 UNAPPROVED HOMEOPATHIC Energique, Inc. GINKGO; SUS SCROFA COLON; SUS SCROFA LUNG; SUS SCROFA PANCREAS; GERMANIUM SESQUIOXIDE; COPPER; MANGANESE; TIN; OXOGLURIC ACID; CITRIC ACID MONOHYDRATE; FUMARIC ACID; MALIC ACID; PYRUVIC ACID; SUCCINIC ACID; 1,2-NAPHTHOQUINONE; ARSENIC; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACONITIC ACID; SODIUM DIETHYL OXALACETATE; PHOSPHORUS 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0441_972e8120-33b6-4017-9fb1-357fb0d9b3ec 44911-0441 HUMAN OTC DRUG Kidnex IV Ginkgo Biloba, Kidney (Suis), Lymph Node (Suis), Urinary Bladder (Suis), Germanium Sesquioxide, Argentum Metallicum, Aurum Metallicum, Cuprum Metallicum, Mercurius Vivus, alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malicum Acidum, Pyruvic Acid, Succinicum Acidum, Naphthochinonum, Nux Vomica, Aconiticum Acidum, Cis-, Natrum Oxalaceticum, Phosphorus LIQUID ORAL 20170921 UNAPPROVED HOMEOPATHIC Energique, Inc. GINKGO; PORK KIDNEY; SUS SCROFA LYMPH; SUS SCROFA URINARY BLADDER; GERMANIUM SESQUIOXIDE; SILVER; GOLD; COPPER; MERCURY; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MALIC ACID; PYRUVIC ACID; SUCCINIC ACID; 1,2-NAPHTHOQUINONE; STRYCHNOS NUX-VOMICA SEED; ACONITIC ACID, (Z)-; SODIUM DIETHYL OXALACETATE; PHOSPHORUS 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0442_5f97d099-38ce-4c93-b44e-c247f2818bb9 44911-0442 HUMAN OTC DRUG Industristat Plantago Major, Taraxacum Officinale, Trifolium Pratense, Symphytum Officinale, Arsenicum Album, Cadmium Sulphuratum, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum LIQUID ORAL 20170926 UNAPPROVED HOMEOPATHIC Energique, Inc. PLANTAGO MAJOR; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; COMFREY ROOT; ARSENIC TRIOXIDE; CADMIUM SULFIDE; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0443_9d1db59a-467c-411c-8398-a82e29e2336d 44911-0443 HUMAN OTC DRUG Vaccistat Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Antimonium Tartaricum, Mezereum, Mercurius Solubilis, Silicea, Thuja Occidentalis, Malandrinum, Variolinum LIQUID ORAL 20170928 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; ANTIMONY POTASSIUM TARTRATE; DAPHNE MEZEREUM BARK; MERCURIUS SOLUBILIS; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; VACCINIA VIRUS; VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 3; 3; 6; 12; 12; 30; 30; 30; 60; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 44911-0444_add108ce-603f-424b-b8ce-0ed2f3d461b4 44911-0444 HUMAN OTC DRUG Influenzinum Influenzinum (2017-2018) LIQUID ORAL 20170929 UNAPPROVED HOMEOPATHIC Energique, Inc. INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED) 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 44911-0445_9548a238-6627-42a0-bc87-c6b4d7f4dca9 44911-0445 HUMAN OTC DRUG Vaccistat Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Antimonium Tartaricum, Mezereum, Mercurius Solubilis, Silicea, Thuja Occidentalis, Malandrinum, Variolinum LIQUID ORAL 20170929 UNAPPROVED HOMEOPATHIC Energique, Inc. BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; ANTIMONY POTASSIUM TARTRATE; DAPHNE MEZEREUM BARK; MERCURIUS SOLUBILIS; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; VACCINIA VIRUS; VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN 3; 3; 6; 12; 12; 30; 30; 30; 60; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 44911-0447_24311d62-4726-4cde-af87-1b3985708881 44911-0447 HUMAN OTC DRUG Osteotone Symphytum Officinale, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Causticum, Hekla Lava, Pulsatilla (Pratensis), Rhus Tox, Silicea, Strontium Carbonicum LIQUID ORAL 20171129 UNAPPROVED HOMEOPATHIC Energique, Inc. COMFREY ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; HEKLA LAVA; ANEMONE PRATENSIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; STRONTIUM CARBONATE 6; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 44911-0448_bd77973e-f14e-4c9e-a9b7-b5720f9ecc7e 44911-0448 HUMAN OTC DRUG Allerphenex I Acetaldehyde, Acetylcholine Chloride, Adrenalinum, Caffeic Acid, Chlorogenic Acid, Cinnamic Acid, Coumarinum, Cysteinum, Gallicum Acidum, Hepar Suis, Histaminum Hydrochloricum, Indolum, Malvin, Mannan, Menadione, Norepinephrine, Octopamine (Hydrochloride), Pancreas Suis, Phenyl Isothiocyanate, Phloridzinum, Quercetin, Salsolinol (Hydrochloride), Serotonin (Hydrochloride), Candida Albicans LIQUID ORAL 20180103 UNAPPROVED HOMEOPATHIC Energique, Inc. ACETALDEHYDE; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; CAFFEIC ACID; CHLOROGENIC ACID; CINNAMIC ACID; COUMARIN; CYSTEINE; GALLIC ACID MONOHYDRATE; PORK LIVER; HISTAMINE DIHYDROCHLORIDE; INDOLE; MALVIN; YEAST MANNAN; MENADIONE; NOREPINEPHRINE; OCTOPAMINE HYDROCHLORIDE; SUS SCROFA PANCREAS; PHENYL ISOTHIOCYANATE; PHLORIZIN; QUERCETIN; SALSOLINOL HYDROCHLORIDE; CANDIDA ALBICANS 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 44929-001_04da03d3-1cb6-40e5-a708-ce9ce6e655ab 44929-001 HUMAN OTC DRUG Cleanize sodium chloride SOLUTION NASAL; OPHTHALMIC 20081125 OTC MONOGRAPH NOT FINAL part349 Laboratoires Gifrer Barbezat SODIUM CHLORIDE 900 mg/100mL E 20171231 44929-002_7336682d-094c-4f71-9e15-6854ed73e304 44929-002 HUMAN OTC DRUG Cleanoz sodium chloride SOLUTION NASAL; OPHTHALMIC 20081125 OTC MONOGRAPH NOT FINAL part341 Laboratoires Gifrer Barbezat SODIUM CHLORIDE 900 mg/100mL E 20171231 44946-1008_8ba03ae3-c022-468a-8eff-ebb4a421299a 44946-1008 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc. SODIUM FLUORIDE .25 mg/1 N 20181231 44946-1009_53421065-825e-4ef7-949e-1ed7bf647990 44946-1009 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE .5 mg/1 N 20181231 44946-1010_91749143-7e08-4365-9f34-fa4a5c0da7e0 44946-1010 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE 1 mg/1 N 20181231 44946-1012_27b8a5b2-f436-4e6d-b9f8-967643b997c7 44946-1012 HUMAN PRESCRIPTION DRUG MVC Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid and cyanocobalamin TABLET, CHEWABLE ORAL 20091220 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN .25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5 mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 44946-1013_27b8a5b2-f436-4e6d-b9f8-967643b997c7 44946-1013 HUMAN PRESCRIPTION DRUG MVC Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid and cyanocobalamin TABLET, CHEWABLE ORAL 20091220 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN .5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5 mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 44946-1014_27b8a5b2-f436-4e6d-b9f8-967643b997c7 44946-1014 HUMAN PRESCRIPTION DRUG MVC Sodium Fluoride, Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Alpha-Tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid and cyanocobalamin TABLET, CHEWABLE ORAL 20091220 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE; VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN 1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5 mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20181231 44946-1015_3424acc5-d8d6-4d35-b83e-f89323bbc289 44946-1015 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20090910 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE .25 mg/1 E 20171231 44946-1016_3424acc5-d8d6-4d35-b83e-f89323bbc289 44946-1016 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20090910 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE .5 mg/1 E 20171231 44946-1017_3424acc5-d8d6-4d35-b83e-f89323bbc289 44946-1017 HUMAN PRESCRIPTION DRUG Ludent Sodium Fluoride TABLET, CHEWABLE ORAL 20090910 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE 1 mg/1 E 20171231 44946-1020_4c8f2bde-c355-4db1-adc4-f372b5666102 44946-1020 HUMAN PRESCRIPTION DRUG MVC-Fluoride Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-Tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, and Cyanocobalamin TABLET, CHEWABLE ORAL 20111207 UNAPPROVED DRUG OTHER Sancilio & Company Inc. SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN .25; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5 mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 44946-1021_887089c1-613a-4336-947e-fb3a4c2bccbc 44946-1021 HUMAN PRESCRIPTION DRUG MVC-Fluoride Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-Tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, and Cyanocobalamin TABLET, CHEWABLE ORAL 20111207 UNAPPROVED DRUG OTHER Sancilio & Company Inc. SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN .5; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5 mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 44946-1022_901a1793-5b94-4ca9-98ae-7428a438e31a 44946-1022 HUMAN PRESCRIPTION DRUG MVC-Fluoride Sodium Fluoride, Vitamin A, Ascorbic Acid, Vitamin D, Alpha-Tocopherol, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, and Cyanocobalamin TABLET, CHEWABLE ORAL 20111207 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN 1; 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5 mg/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 44946-1023_19a621a6-365c-404c-887f-c9f51fad3d30 44946-1023 HUMAN PRESCRIPTION DRUG Multivitamin with fluoride .Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, and Vitamin D TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; .25; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 44946-1024_dbe815bb-b981-42bf-ba55-13d6e3add71b 44946-1024 HUMAN PRESCRIPTION DRUG Multivitamin with fluoride .Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, and Vitamin D TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; .5; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] N 20181231 44946-1025_fde4127b-4d62-4bc2-8bd5-7fa3399cd2c2 44946-1025 HUMAN PRESCRIPTION DRUG Multivitamin with fluoride .Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, and Vitamin D TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; 1; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] N 20181231 44946-1032_aa5afa5f-7c2c-417c-bbb3-8b02e76e5d7f 44946-1032 HUMAN PRESCRIPTION DRUG Sodium Fluoride Sodium Fluoride SOLUTION/ DROPS ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE .5 mg/mL N 20181231 44946-1035_3db68350-344b-4e50-b3b4-79d4dd3f3a7d 44946-1035 HUMAN PRESCRIPTION DRUG Tri-Vitamin with Fluoride Vitamin A, Ascorbic Acid, Vitamin D, and Sodium Fluoride SOLUTION/ DROPS ORAL 20111220 UNAPPROVED DRUG OTHER Sancilio & Company Inc VITAMIN A; ASCORBIC ACID; VITAMIN D; SODIUM FLUORIDE 1500; 35; 400; .25 [iU]/mL; mg/mL; [iU]/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20181231 44946-1045_f6b0b78f-7c06-4131-a5f5-f1f790b973e4 44946-1045 HUMAN PRESCRIPTION DRUG PNV Prenatal Plus Multivitamin VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, and CUPRIC OXIDE TABLET ORAL 20130401 UNAPPROVED DRUG OTHER Sancilio & Company Inc VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE 2000; 2000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 44946-1046_f3af7e93-287a-4e40-9934-daf64e15efde 44946-1046 HUMAN PRESCRIPTION DRUG PNV Prenatal Vitamin Plus Vitamin A .Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, and Vitamin A Acetate TABLET ORAL 20121207 UNAPPROVED DRUG OTHER Sancilio & Company Inc .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; FERROUS FUMARATE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE 15; 60; 400; 4.5; 1; 27; 50; 13.5; 1.05; 1.2; 1.05; 2500 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] E 20171231 44946-1050_821e0038-5a99-4f53-a627-bec0bc200598 44946-1050 HUMAN PRESCRIPTION DRUG Neutral Sodium Fluoride Sodium Fluoride RINSE ORAL 20130101 UNAPPROVED DRUG OTHER Sancilio & Company Inc SODIUM FLUORIDE 20 mg/mL E 20171231 44946-2001_298b2592-7ef8-4c6b-a6f4-ae9c024e5476 44946-2001 HUMAN PRESCRIPTION DRUG Prenatal Plus Multivitamin Plus DHA MiniCaps VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, TOCOPHEROL, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE, NIACINAMIDE, and Fish Oil KIT 20161115 UNAPPROVED DRUG OTHER Sancilio & Company, Inc. E 20171231 44946-2005_f2c5e95a-65f6-423a-9c1a-c2ece1c8b9d4 44946-2005 HUMAN PRESCRIPTION DRUG Multivitamin Drops with Fluoride VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, TOCOPHEROL, THIAMINE ION, Riboflavin, NIACINAMIDE, PYRIDOXINE, CYANOCOBALAMIN, and Sodium Fluoride SOLUTION/ DROPS ORAL 20170410 UNAPPROVED DRUG OTHER Sancilio & Company, Inc. VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; TOCOPHEROL; THIAMINE ION; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE; CYANOCOBALAMIN; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 8; .4; 2; .25 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 44946-2006_8f83c3e1-fab6-42b6-9462-da33b847f138 44946-2006 HUMAN PRESCRIPTION DRUG Multivitamin Drops with Fluoride Vitamin A, Ascorbic Acid, Cholecalciferol, Tocopherol, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Cyanocobalamin, and Sodium Fluoride SOLUTION/ DROPS ORAL 20170410 UNAPPROVED DRUG OTHER Sancilio & Company, Inc. VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE; CYANOCOBALAMIN; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 8; .4; 2; .5 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 44946-2016_7010f259-e5db-470e-bd55-44e99d6788fa 44946-2016 HUMAN PRESCRIPTION DRUG MultiVitamin Drops with Fluoride and Iron Vitamin A Palmitate, Ascorbic Acid, Cholecalciferol, Tocopherol, Thiamine Hydrochloride, Riboflavin 5-Phosphate Sodium, Niacinamide, Pyridoxine Hydrochloride, Ferrous Sulfate, and Sodium Fluoride LIQUID ORAL 20170824 UNAPPROVED DRUG OTHER Sancilio & Company, Inc. VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; TOCOPHEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FERROUS SULFATE; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 8; .4; 10; .25 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 44946-2017_83aa0ac0-3fe0-45c2-887f-406de26995e3 44946-2017 HUMAN PRESCRIPTION DRUG Multivitamin Drops with Fluoride Vitamin A Palmitate, Ascorbic Acid, CHOLECALCIFEROL, TOCOPHEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, and Sodium Fluoride LIQUID ORAL 20170824 UNAPPROVED DRUG OTHER Sancilio & Company, Inc. VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; TOCOPHEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 8; .4; 2; .25 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; mg/mL Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20181231 44946-2018_83aa0ac0-3fe0-45c2-887f-406de26995e3 44946-2018 HUMAN PRESCRIPTION DRUG Multivitamin Drops with Fluoride Vitamin A Palmitate, Ascorbic Acid, CHOLECALCIFEROL, TOCOPHEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, and Sodium Fluoride LIQUID ORAL 20170824 UNAPPROVED DRUG OTHER Sancilio & Company, Inc. VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; TOCOPHEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 8; .4; 2; .5 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; mg/mL Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 45014-130_c96c5d9b-5566-4135-9438-0032c4e9b5a0 45014-130 HUMAN OTC DRUG Acetaminophen Acetaminophen LIQUID ORAL 20111001 OTC MONOGRAPH FINAL part343 Accudial Pharmaceutical, Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 45014-131_c9eb1f5c-6b5a-4ba5-932f-412a2fa463a1 45014-131 HUMAN OTC DRUG Pain and Fever Acetaminophen SUSPENSION ORAL 20100104 OTC MONOGRAPH FINAL part343 Accudial Pharmaceutical, Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 45014-136_33988a22-7905-4454-a0ee-6e402fd9ba5e 45014-136 HUMAN OTC DRUG Childrens Accudial Pain reliever/ Fever reducer Acetaminophen SUSPENSION ORAL 20120425 OTC MONOGRAPH FINAL part343 Accudial Pharmaceutical, Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 45014-137_3614e44e-8510-4fd2-9762-741b9659323d 45014-137 HUMAN OTC DRUG Childrens ACCUDIAL Pain reliever/ Fever reducer Acetaminophen SUSPENSION ORAL 20120425 OTC MONOGRAPH FINAL part343 Accudial Pharmaceutical, Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 45014-138_12ffc15e-707e-4f2d-8be8-731ded3db3aa 45014-138 HUMAN OTC DRUG Childrens ACCUDIAL Pain reliever/ Fever reducer Acetaminophen SUSPENSION ORAL 20120425 OTC MONOGRAPH FINAL part343 Accudial Pharmaceutical, Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 45014-139_e3231b59-92e6-4c68-9e50-e469fc2c2958 45014-139 HUMAN OTC DRUG Childrens ACCUDIAL Pain reliever/ Fever reducer Acetaminophen SUSPENSION ORAL 20120425 OTC MONOGRAPH FINAL part343 Accudial Pharmaceutical, Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 45014-140_ad761594-3a4d-403b-9f45-6cdbf365d0ab 45014-140 HUMAN OTC DRUG Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20091026 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 45014-141_bd6d673a-27d7-4fa7-9d0f-62a89882ea6e 45014-141 HUMAN OTC DRUG Allergy and Stuffy Nose Chlorpheniramine Maleate and Phenylephrine Hydrochloride LIQUID ORAL 20091111 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL E 20171231 45014-150_f0ffa4f3-7a9c-44ed-a4c1-cba9af870345 45014-150 HUMAN OTC DRUG Chest Congestion Guaifenesin LIQUID ORAL 20091026 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. GUAIFENESIN 100 mg/5mL E 20171231 45014-151_3c3797ea-03dd-41d3-8f2d-bcd80ee1c040 45014-151 HUMAN OTC DRUG Cough and Cold Chlorpheniramine Maleate and Dextromethorphan Hydrobromide LIQUID ORAL 20091125 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 1; 7.5 mg/5mL; mg/5mL E 20171231 45014-152_0fc0b6aa-ff81-4bff-b9d5-e10634b3c244 45014-152 HUMAN OTC DRUG Daytime Cough And Cold Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20091026 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 1.25 mg/5mL; mg/5mL E 20171231 45014-153_fa42da7d-006e-41a9-9885-5cb317e86020 45014-153 HUMAN OTC DRUG Runny Nose and Cough Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20091104 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE .5; 5; 1.25 mg/5mL; mg/5mL; mg/5mL E 20171231 45014-154_2d46d37d-abad-4b65-a19c-69d843ea6662 45014-154 HUMAN OTC DRUG Nite Time Cold and Cough Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride LIQUID ORAL 20091125 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL E 20171231 45014-158_97558c3c-84f5-4185-8462-a113bd2e3be8 45014-158 HUMAN OTC DRUG Daytime Cough and Cold Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride SOLUTION ORAL 20130201 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL E 20171231 45014-159_9eaf18d1-da77-46e4-9730-3671f8529fb6 45014-159 HUMAN OTC DRUG Nite Time Cold and Cough Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride SOLUTION ORAL 20130201 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL E 20171231 45014-161_f8c91261-b067-4bea-810b-6b28dc893b0e 45014-161 HUMAN OTC DRUG Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20130201 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 45014-163_c7ba2caf-ed17-4171-b900-4d3e0155cdc4 45014-163 HUMAN OTC DRUG Chest Congestion Guaifenesin SOLUTION ORAL 20130201 OTC MONOGRAPH FINAL part341 Accudial Pharmaceutical, Inc. GUAIFENESIN 100 mg/5mL E 20171231 45028-001_70658ea4-f35a-47e5-9d3e-817654b72d4a 45028-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20101130 UNAPPROVED MEDICAL GAS North Central Medical Supply, Inc. OXYGEN 992 mL/L N 20181231 45043-001_9c667450-88cd-45bf-9ef4-23f7d2d7d4f4 45043-001 HUMAN PRESCRIPTION DRUG Cholbam Cholic Acid CAPSULE ORAL 20150331 NDA NDA205750 Manchester Pharmaceuticals CHOLIC ACID 50 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] E 20171231 45043-002_9c667450-88cd-45bf-9ef4-23f7d2d7d4f4 45043-002 HUMAN PRESCRIPTION DRUG Cholbam Cholic Acid CAPSULE ORAL 20150331 NDA NDA205750 Manchester Pharmaceuticals CHOLIC ACID 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] E 20171231 45043-558_976f404f-4857-4bad-9a3c-9bf3d5ca9f5b 45043-558 HUMAN PRESCRIPTION DRUG Vecamyl Mecamylamine Hydrochloride TABLET ORAL 20130319 ANDA ANDA204054 Manchester Pharmaceuticals MECAMYLAMINE HYDROCHLORIDE 2.5 mg/1 Autonomic Ganglionic Blocker [EPC],Decreased Autonomic Ganglionic Activity [PE] N 20181231 45043-876_d6369783-3cd7-4d99-8ddd-07102a5512f9 45043-876 HUMAN PRESCRIPTION DRUG Chenodal Chenodiol TABLET, FILM COATED ORAL 20091001 ANDA ANDA091019 Manchester Pharmaceuticals Inc. CHENODIOL 250 mg/1 E 20171231 45046-0001_4917b7c0-8e44-4ba8-89a2-e244e6b65ac1 45046-0001 HUMAN OTC DRUG Ultimate High IGF 1 IGF 2 Arnica Montana, Deer Antler Velvet, Hepar Bovinum, HGH, HGH, IGF 1, Pituitary Bovinum, Pituitary Bovinum LIQUID ORAL 20130325 UNAPPROVED HOMEOPATHIC NewTropin, Inc. ARNICA MONTANA; CERVUS ELAPHUS VELVET; BEEF LIVER; SOMATROPIN; MECASERMIN; BOS TAURUS PITUITARY GLAND; THUJA OCCIDENTALIS LEAF 6; 8; 6; 24; 8; 5; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 45124-001_7f7ff9c6-8f65-45fd-9a30-35fcee39d2fd 45124-001 HUMAN OTC DRUG Oscar de la Renta Moisturizing Sunscreen SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20120411 OTC MONOGRAPH FINAL part352 Oscar de la Renta LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 6 mL/100mL; mL/100mL; mL/100mL N 20181231 45146-110_0e4e9936-ec7e-4a5d-8dd9-c04e2b4407d8 45146-110 HUMAN PRESCRIPTION DRUG Orabloc articaine hydrochloride and epinephrine bitartrate INJECTION SUBMUCOSAL 20110301 NDA NDA022466 Pierrel S.p.A. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 45146-120_0e4e9936-ec7e-4a5d-8dd9-c04e2b4407d8 45146-120 HUMAN PRESCRIPTION DRUG Orabloc articaine hydrochloride and epinephrine bitartrate INJECTION SUBMUCOSAL 20110301 NDA NDA022466 Pierrel S.p.A. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 45149-014_0eba1ccb-a938-4ae0-abee-5e05f0ee99fd 45149-014 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19650101 NDA NDA205815 Linde Merchant Production Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 45156-2250_e620a5fb-14fb-48b6-8e98-abeb9c19f21d 45156-2250 HUMAN OTC DRUG Flower O Life Pain Relieving Balm Camphor, Menthol, Wintergreen Oil OIL TOPICAL 20110808 OTC MONOGRAPH FINAL part348 Skin Deep CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 6; 15; 30 g/100g; g/100g; g/100g E 20171231 45156-5502_0f21ff3e-6619-41ee-bde7-473b91cb55e4 45156-5502 HUMAN OTC DRUG Inflammation OTC Bruise Relief Camphor LOTION TOPICAL 20110808 OTC MONOGRAPH FINAL part348 Skin Deep CAMPHOR (NATURAL) 32 g/1000g E 20171231 45156-5605_c241ecee-ca1a-4186-88d7-f6665fea3dcf 45156-5605 HUMAN OTC DRUG Inflammation OTC Deep Pain Care Hot Camphor, Capsicum, Menthol LOTION TOPICAL 20110816 OTC MONOGRAPH FINAL part348 Skin Deep CAMPHOR (NATURAL); CAPSICUM; MENTHOL 4; 38; 17 g/1000g; g/1000g; g/1000g E 20171231 45156-5610_a1c737d4-eec3-4bda-b406-54aab5b66e3f 45156-5610 HUMAN OTC DRUG Inflammation OTC Deep Pain Care Cold Camphor, Menthol LOTION TOPICAL 20110816 OTC MONOGRAPH FINAL part348 Skin Deep CAMPHOR (NATURAL); MENTHOL 18; 16 g/600g; g/600g E 20171231 45156-5616_2b840267-8a9f-4168-a63f-0b1d67647932 45156-5616 HUMAN OTC DRUG Inflammation OTC Radiation Relief Allantoin LOTION TOPICAL 20100613 OTC MONOGRAPH FINAL part347 Skin Deep ALLANTOIN 3 g/600g E 20171231 45163-451_41da3fff-f7b1-42d3-94c0-a21687449983 45163-451 HUMAN OTC DRUG NANO SILVER TOOTHPASTE SODIUM MONOFLUOROPHOSPHATE, SILICON DIOXIDE, GLYCERIN PASTE ORAL 20100120 OTC MONOGRAPH FINAL part355 Nanowell Korea Inc SODIUM MONOFLUOROPHOSPHATE; SILICON DIOXIDE; GLYCERIN 1.4; 14; 5 g/200g; g/200g; g/200g E 20171231 45167-030_e366ebbe-95bc-4027-a23e-70f15ec696de 45167-030 HUMAN OTC DRUG NWC21 NATURAL SUN PROTECTOR SPF35 TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 CLEANSIA CORPORATION LTD. TITANIUM DIOXIDE 1.18 mL/60mL E 20171231 45167-040_4b308335-55a5-486f-ae21-9e598a284275 45167-040 HUMAN OTC DRUG NWC21 NATURAL SUN PROTECTOR SPF50 TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 CLEANSIA CORPORATION LTD. TITANIUM DIOXIDE 2.1 mL/60mL E 20171231 45167-167_2fc4d5d7-bf45-4b1d-893b-12d05f919527 45167-167 HUMAN OTC DRUG NWC21 NATURAL WHITE CREAM TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20100121 OTC MONOGRAPH FINAL part352 Cleansia Co Ltd TITANIUM DIOXIDE; ZINC OXIDE 2; .8 g/200g; g/200g E 20171231 45167-451_1e6f4afe-fffe-4088-bcb0-7426d6281984 45167-451 HUMAN OTC DRUG NWC 21 NATURAL PREMIUM BB CREAM OCTINOXATE, TITANIUM DIOXIDE, ENZACAMENE CREAM TOPICAL 20100121 OTC MONOGRAPH FINAL part352 Cleansia Co Ltd OCTINOXATE; TITANIUM DIOXIDE; ENZACAMENE 3.75; 1.1; 1 g/50g; g/50g; g/50g E 20171231 45167-516_b5ab35c8-9590-4ff4-9c71-3d19867ec713 45167-516 HUMAN OTC DRUG QT SUN BLOCK OCTINOXATE, TITANIUM DIOXIDE, ENZACAMENE CREAM TOPICAL 20100121 OTC MONOGRAPH FINAL part352 Cleansia Co Ltd OCTINOXATE; TITANIUM DIOXIDE; ENZACAMENE 7.5; 2.2; 2 g/100g; g/100g; g/100g E 20171231 45334-205_45e85e34-fc18-0f9b-e054-00144ff88e88 45334-205 HUMAN OTC DRUG Free and Clear Pyrithione Zinc SHAMPOO TOPICAL 20170202 OTC MONOGRAPH FINAL part358H Pharmaceutical Specialties, Inc. PYRITHIONE ZINC 2 g/100mL N 20181231 45334-301_58b1c846-e3d8-21af-e053-2991aa0a2b8a 45334-301 HUMAN OTC DRUG Vanicream Diaper Rash Dimethicone, Zinc Oxide OINTMENT TOPICAL 20140630 OTC MONOGRAPH FINAL part347 Pharmaceutical Specialties, Inc. DIMETHICONE; ZINC OXIDE 11; 400 mg/g; mg/g N 20181231 45334-305_4145a4c6-8cc5-5d9d-e054-00144ff8d46c 45334-305 HUMAN OTC DRUG Vanicream Anti-perspirant/Deodorant Aluminum zirconium trichlorohydrex gly STICK TOPICAL 20161111 OTC MONOGRAPH FINAL part350 Pharmaceutical Specialties, Inc. ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 12.8 g/64g N 20181231 45334-327_5cffb8df-ddb8-d12a-e053-2991aa0a6ed4 45334-327 HUMAN OTC DRUG Vanicream HC Anti-Itch Hydrocortisone CREAM TOPICAL 20160126 OTC MONOGRAPH NOT FINAL part348 Pharmaceutical Specialties, Inc. HYDROCORTISONE ACETATE 1.12 g/100g N 20181231 45334-350_26b7ffcd-d29a-628e-e054-00144ff88e88 45334-350 HUMAN OTC DRUG Vanicream Lip Protectant/Sunscreen Dimethicone, Titanium dioxide, Zinc oxide OINTMENT TOPICAL 20140902 OTC MONOGRAPH FINAL part352 Pharmaceutical Specialties, Inc. TITANIUM DIOXIDE; DIMETHICONE; ZINC OXIDE 15; 12; 150 mg/g; g/g; mg/g N 20181231 45334-353_5ae22440-c747-9199-e053-2991aa0acad8 45334-353 HUMAN OTC DRUG VANICREAM Sunscreen BROAD SPECTRUM SPF 30 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20130419 OTC MONOGRAPH FINAL part352 Pharmaceutical Specialties, Inc. TITANIUM DIOXIDE; ZINC OXIDE .034; .06 g/g; g/g N 20181231 45334-355_5b42924a-7cc5-8f2e-e053-2a91aa0a6c70 45334-355 HUMAN OTC DRUG VANICREAM Sunscreen BROAD SPECTRUM SPF 35 octinoxate and zinc oxide CREAM TOPICAL 20130418 OTC MONOGRAPH FINAL part352 Pharmaceutical Specialties, Inc. OCTINOXATE; ZINC OXIDE .028; .11 g/g; g/g N 20181231 45334-356_5cdc3710-8445-1366-e053-2991aa0a8de9 45334-356 HUMAN OTC DRUG VANICREAM Sunscreen BROAD SPECTRUM SPF 50 PLUS Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20130327 OTC MONOGRAPH FINAL part352 Pharmaceutical Specialties, Inc. TITANIUM DIOXIDE; ZINC OXIDE .05; .07 g/g; g/g N 20181231 45334-390_5c8822de-684c-1e56-e053-2a91aa0a4378 45334-390 HUMAN OTC DRUG Vanicream Z-Bar Pyrithione Zinc SOAP TOPICAL 20160915 OTC MONOGRAPH FINAL part358H Pharmaceutical Specialties, Inc. PYRITHIONE ZINC 2 g/100g N 20181231 45334-600_5499839e-49f3-62e1-e054-00144ff8d46c 45334-600 HUMAN OTC DRUG Vaniply dimethicone OINTMENT TOPICAL 20110224 20190630 OTC MONOGRAPH FINAL part347 Pharmaceutical Specialties, Inc. DIMETHICONE 10 mg/g N 20181231 45334-601_58b23e79-d62e-8e9a-e053-2a91aa0a492e 45334-601 HUMAN OTC DRUG Vaniply Dimethicone OINTMENT TOPICAL 20170807 OTC MONOGRAPH FINAL part347 Pharmaceutical Specialties, Inc. DIMETHICONE 20 mg/g N 20181231 45341-0001_15225540-4aa7-4a6a-b4a5-1c81221b01f1 45341-0001 HUMAN OTC DRUG Artalgia Carduus Marianus, Arnica Montana, Agaricus Muscarius, Baryta Carbonica, Bellis Perennis, Glonoinum, Hamamelis Virginiana LIQUID ORAL 20120928 UNAPPROVED HOMEOPATHIC Todd Horton DPM SILYBUM MARIANUM SEED OIL; ARNICA MONTANA; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; BARIUM CARBONATE; BELLIS PERENNIS; NITROGLYCERIN; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MERCURIUS SOLUBILIS; LEAD; CLAVICEPS PURPUREA SCLEROTIUM; VANADIUM; ACTIVATED CHARCOAL; HYPERICUM PERFORATUM; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 45343-0001_f2b69adb-510f-4f8c-a7a4-89cca41b2377 45343-0001 HUMAN OTC DRUG Recapture HGH Phosphoricum Acidum, Heparus Suis, HGH, IGF-1, Pituitarum (suis) SPRAY ORAL 20120629 UNAPPROVED HOMEOPATHIC DefyAging.com Inc. PHOSPHORIC ACID; PORK LIVER; SOMATROPIN; MECASERMIN; SUS SCROFA PITUITARY GLAND 3; 6; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 45405-001_37d8b346-1e81-470d-b94b-8c9f54c76e81 45405-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19730101 NDA NDA205865 Gas Innovations LLC OXYGEN 99 L/100L N 20181231 45405-002_798de150-db07-4b02-a0fc-4007c4e9b3ee 45405-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19720101 NDA NDA205866 Gas Innovations LLC NITROGEN 99 L/100L N 20181231 45548-141_54998e92-2930-43ca-bfbd-3c898d13b996 45548-141 HUMAN PRESCRIPTION DRUG TECHNETIUM TC 99M SESTAMIBI Technetium TC 99m Sestamibi INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090701 ANDA ANDA078806 Jubilant Draximage (USA) Inc. TECHNETIUM TC-99M SESTAMIBI 1 mg/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20191231 45567-0030_a9ed0b6a-2896-4a79-88dd-9ec94725d5dd 45567-0030 HUMAN PRESCRIPTION DRUG Kit for the Prepartion of Technetium Tc99m Sulfur Colloid Technetium Tc 99m Sulfur Colloid KIT 19780419 NDA NDA017858 Pharmalucence Inc. N 20181231 45567-0040_7e55e7ef-f3ff-40f6-ac93-d8a2789d7710 45567-0040 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc 99M Medronate TC 99M MEDRONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19790829 NDA NDA018124 Pharmalucence, Inc. TECHNETIUM TC-99M MEDRONATE 20 mg/10mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 45567-0060_369869c4-dede-462a-9a31-085783ac88b8 45567-0060 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc99m Pyrophosphate Technetium Tc99m Pyrophosphate INJECTION INTRAVENOUS 19870630 NDA NDA019039 Pharmalucence, Inc. TECHNETIUM TC-99M PYROPHOSPHATE 12 mg/10mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 45567-0455_dfa4635c-3e4f-421d-809b-2c1c4bdb2584 45567-0455 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc 99m Mebrofenin Kit for the Preparation of Technetium Tc 99m Mebrofenin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080129 ANDA ANDA078242 Pharmalucence, Inc. MEBROFENIN 45 mg/10mL N 20181231 45567-0475_3a7eb7d8-af53-4c61-81b9-86931542f9fd 45567-0475 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc99m Disofenin HEPATOLITE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19820316 NDA NDA018467 Pharmalucence, Inc. TECHNETIUM TC-99M DISOFENIN 20 mg/10mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 45567-0555_3f5f3423-7800-4c53-9358-8918d4174e22 45567-0555 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc99m Sestamibi TECHNETIUM TC-99M SESTAMIBI INJECTION INTRAVENOUS 20090710 ANDA ANDA079157 Pharmalucence, Inc. TECHNETIUM TC-99M SESTAMIBI 1 mg/10mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 45591-002_60500e32-4fb6-5671-e053-2991aa0a73fb 45591-002 HUMAN OTC DRUG Chigg Away Benzocaine LOTION TOPICAL 20061201 OTC MONOGRAPH FINAL part348 Pierson Laboratories, Inc. BENZOCAINE 50 mg/mL N 20181231 45591-041_6050b319-9903-333d-e053-2a91aa0ad1f3 45591-041 HUMAN OTC DRUG Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 20171214 OTC MONOGRAPH FINAL part347 Pierson Laboratories ZINC OXIDE 160 mg/mL N 20181231 45632-736_482e2384-ef49-01c7-e054-00144ff88e88 45632-736 HUMAN OTC DRUG TriMotion Pain Relief MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part348 NatureMed, Inc MENTHOL; METHYL SALICYLATE 25; 100 mg/g; mg/g N 20181231 45634-121_a51b04fa-87a1-4b0e-b383-8c9c0c30895e 45634-121 HUMAN OTC DRUG Perricone No foundation foundation Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20120411 OTC MONOGRAPH NOT FINAL part352 NV Perricone LLC ZINC OXIDE; TITANIUM DIOXIDE 12.2; 3.2 mL/100mL; mL/100mL E 20171231 45725-001_e120445c-d52a-4fd5-bf88-b75f34aad1ec 45725-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20070101 UNAPPROVED MEDICAL GAS Advanced Apothecaries Inc. dba Health Depot OXYGEN 99 L/100L E 20171231 45737-203_f94b4022-2a3a-4cf6-95af-9c2ded70ad6f 45737-203 HUMAN OTC DRUG BIO Dtuss DMX Brompheniramine Maleate, Dextromethorphan, Pseudoephedrine LIQUID ORAL 20111201 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 20; 30 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-205_e0a64ad6-3457-491e-ba31-c2cad4dd634e 45737-205 HUMAN OTC DRUG BioGtuss Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 300; 15 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-206_432ffab3-9f96-4d68-8935-a2288e92bc65 45737-206 HUMAN OTC DRUG Bionel Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 200; 30 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-207_76748794-8d3f-48f3-b9b6-33309ff3d3f3 45737-207 HUMAN OTC DRUG Bionel Pediatric Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 50; 15 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-208_db9e055a-714f-49b3-9701-e0a87c8ca09d 45737-208 HUMAN OTC DRUG Biocotron-D Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl SUSPENSION/ DROPS ORAL 20130301 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-209_528a64b3-97e9-44ce-a145-45e236c22c25 45737-209 HUMAN PRESCRIPTION DRUG Biocotron - Dextromethorphan, Guaifenesin LIQUID ORAL 20090101 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] N 20181231 45737-210_3bf9cec4-9e30-44d2-b0d3-373167dbaddd 45737-210 HUMAN OTC DRUG Bionatuss DXP Dexbrompheniramine Maleate, Dextromethorphan, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 20; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-211_50874915-9770-492e-b883-56e72c6fe1b4 45737-211 HUMAN OTC DRUG Biospec DMX Dextromethorphan, Guaifenesin LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 15; 25 mg/5mL; mg/5mL N 20181231 45737-217_06e03308-11e6-4477-8b8e-22d9c68f43dd 45737-217 HUMAN OTC DRUG Biobron SF Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 350; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-218_cf40143f-720f-4edf-ab01-6a6f22c95255 45737-218 HUMAN OTC DRUG Bio-B Kids Dextromethorphan,Chlorpheniramine Maleate, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 15; 4; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-221_13b19375-4fe2-40ad-8ff1-efbc6684588d 45737-221 HUMAN OTC DRUG Biodesp DM Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20090101 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-225_a61ed81b-7422-43d6-8b84-c69810093637 45737-225 HUMAN OTC DRUG BioTPres Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 200; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-226_f84c77b1-d231-425c-9bc7-b88424c9129c 45737-226 HUMAN OTC DRUG Bio T Pres-B BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20121101 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 20; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-227_2cd2b7f9-9a3d-4b30-b4a4-99f21e7c85a4 45737-227 HUMAN OTC DRUG BioTPres Pediatric Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 75; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-230_c90fcf72-a633-40f0-985a-8d2aeb648f79 45737-230 HUMAN OTC DRUG Bio-S-Pres DX Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20130301 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/mL; mg/mL; mg/mL N 20191231 45737-239_3e9176ef-8eb2-477d-a3ae-82e1a0298fb4 45737-239 HUMAN OTC DRUG BIO-CNEX Dexbrompheniramine Maleate, Pseudoephedrine HCl LIQUID ORAL 20170101 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 30 mg/5mL; mg/5mL N 20181231 45737-240_ffde1631-ef74-4f74-9225-23758811429c 45737-240 HUMAN OTC DRUG Bio-G-Tuss Pediatric Drops Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20160401 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 7.5; 88; 2.5 mg/mL; mg/mL; mg/mL N 20181231 45737-242_a4ae9d65-88c6-4ad7-be39-e48d38128302 45737-242 HUMAN OTC DRUG BioGtuss NF Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20100901 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 28; 388; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-246_769465ec-c7b0-46f0-ac07-a82b9f059058 45737-246 HUMAN OTC DRUG Biobron DX Dextromethorphan, Guaifenesin, Phenylephrine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-249_4524b41f-d175-4411-a05c-a29f4dd1c5cc 45737-249 HUMAN OTC DRUG Biocof Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine HCL LIQUID ORAL 20120701 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/5mL; mg/5mL; mg/5mL N 20191231 45737-250_a9aad8d1-16ca-4bc3-9a93-2d3ecf7619de 45737-250 HUMAN OTC DRUG BIO-RYTUSS CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120801 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/5mL; mg/5mL; mg/5mL N 20191231 45737-251_58efaddb-718a-4ddf-b8aa-76ce8e5eb009 45737-251 HUMAN OTC DRUG Bio-Z-Cough Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20120701 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/5mL; mg/5mL N 20181231 45737-261_36fe8315-671b-4977-9a84-20ddc65a70fc 45737-261 HUMAN OTC DRUG Biocotron PED Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150301 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 350; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 45737-263_db44f724-8733-4f76-8c4f-c7d51118a2a4 45737-263 HUMAN OTC DRUG Biodesp DM NF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150301 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20191231 45737-264_7741bacf-2375-4172-ae43-54707357952d 45737-264 HUMAN OTC DRUG Biospec DMX Dextromethorphan, Guaifenesin LIQUID ORAL 20150301 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 187 mg/5mL; mg/5mL N 20181231 45737-605_678a8e9a-7480-4fbe-ad80-4907383b59c8 45737-605 HUMAN OTC DRUG Biogtuss TR Guaifenesin, Phenylephrine HCl, Dextromethorphan HBr TABLET ORAL 20140401 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 388; 10; 28 mg/1; mg/1; mg/1 E 20171231 45737-606_935db096-3fe5-44ca-b041-210d4ecfb96a 45737-606 HUMAN OTC DRUG Biophex TR Guaifenesin, Phenylephrine HCl TABLET ORAL 20140401 OTC MONOGRAPH FINAL part341 Advanced Generic Corporation GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 388; 10 mg/1; mg/1 E 20171231 45737-610_9e00b9ef-b627-4708-bde2-f1f121b978d0 45737-610 HUMAN OTC DRUG Biogesic Acetaminophen, Dexbrompheniramine Maleate TABLET ORAL 20170101 OTC MONOGRAPH NOT FINAL part343 Advanced Generic Corporation ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE 500; 1 mg/1; mg/1 N 20181231 45737-701_32f1abba-9cea-4bee-b116-d2ed47335394 45737-701 HUMAN OTC DRUG BioDCream Zinc Oxide CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part347 Advanced Generic Corporation ZINC OXIDE 15.25 g/100g N 20181231 45737-702_e701b5da-0fee-4cce-b03b-f542312d3616 45737-702 HUMAN OTC DRUG Umbiliclean Isopropyl Alcohol LIQUID TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part333A Advanced Generic Corporation ISOPROPYL ALCOHOL 90 mL/100mL N 20181231 45765-5100_fba075ec-06b1-4709-8e31-95bed7970c45 45765-5100 HUMAN OTC DRUG Baby Magic Medicated Patty Cake Zinc Oxide CREAM TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part347 Naterra International INC. ZINC OXIDE 2.75 g/11g E 20171231 45765-5130_95dba6f2-e2e4-4109-8146-1bf624d67d0f 45765-5130 HUMAN OTC DRUG Baby Magic Diaper Rx Zinc Oxide CREAM TOPICAL 20100430 OTC MONOGRAPH NOT FINAL part347 Naterra International INC. ZINC OXIDE 23.8 g/85g E 20171231 45765-5135_c2d311fd-e00b-4d97-be51-60b34eebb2bd 45765-5135 HUMAN OTC DRUG Fresh Baby Scent Soothing Jelly Petroleum GEL TOPICAL 20090112 OTC MONOGRAPH NOT FINAL part347 Naterra International INC. PETROLATUM 70.9787 g/71g E 20171231 45765-5142_7eb7f345-33c5-41d7-bc5d-c3d2e8b3ce77 45765-5142 HUMAN OTC DRUG Gentle Eczema Balm Colloid Oatmeal STICK TOPICAL 20101012 OTC MONOGRAPH NOT FINAL part347 Naterra International INC. OATMEAL .112 g/14g E 20171231 45782-0000_e6f70dd6-68ce-41a6-854b-3c925090e63d 45782-0000 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20060101 UNAPPROVED MEDICAL GAS Mountain Valley Home Medical Equipment, Inc OXYGEN 99 L/100L E 20171231 45802-001_fea34029-0e79-4d3f-9f83-327afbaaf620 45802-001 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20140409 ANDA ANDA078326 Perrigo New York Inc NICOTINE 4 mg/1 N 20181231 45802-004_840ea67f-77eb-43d0-8bfc-53dfd9b18cbd 45802-004 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20060331 ANDA ANDA085025 Perrigo New York Inc HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-008_c9d6a486-32f8-4fc7-bbea-29b68ba8133d 45802-008 HUMAN OTC DRUG loratadine d 24 hour Loratadine, Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20140425 ANDA ANDA075706 Perrigo New York Inc PSEUDOEPHEDRINE SULFATE; LORATADINE 240; 10 mg/1; mg/1 N 20181231 45802-009_e6af2549-50b5-4b7f-a0c0-de0f7626b6f3 45802-009 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide SOLUTION/ DROPS AURICULAR (OTIC) 20171004 ANDA ANDA202849 Perrigo New York Inc FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-014_840ea67f-77eb-43d0-8bfc-53dfd9b18cbd 45802-014 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20060613 ANDA ANDA085027 Perrigo New York Inc HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-021_0e059e98-cddf-4c2f-abaa-c9bc86863745 45802-021 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate LOTION TOPICAL 20060630 ANDA ANDA072538 Perrigo New York Inc BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-026_b2418340-efeb-45a7-bdb4-0f8771f0eb11 45802-026 HUMAN PRESCRIPTION DRUG azelastine hcl nasal Azelastine HCl SPRAY NASAL 20140509 ANDA ANDA202743 Perrigo New York Inc AZELASTINE HYDROCHLORIDE 205.5 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 45802-038_b93dceab-ed9c-4b4a-8f34-be12cbe398ac 45802-038 HUMAN PRESCRIPTION DRUG erythromycin erythromycin SOLUTION TOPICAL 20111219 ANDA ANDA063038 Perrigo New York Inc ERYTHROMYCIN 20 mg/mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 45802-039_a3f624ca-6cda-45d4-bd3b-f99fa7615895 45802-039 HUMAN PRESCRIPTION DRUG azelastine hydrochloride azelastine hydrochloride SPRAY, METERED NASAL 20150409 20180301 NDA NDA022371 Perrigo New York Inc AZELASTINE HYDROCHLORIDE 205.5 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 45802-040_55cf4839-2c5b-427e-86b3-2a3b5085de84 45802-040 HUMAN PRESCRIPTION DRUG SELENIUM SULFIDE SELENIUM SULFIDE LOTION TOPICAL 20060925 ANDA ANDA089996 Perrigo New York Inc SELENIUM SULFIDE 2.5 mg/100mL N 20181231 45802-042_6a686565-493b-458c-a554-276920f6e0c8 45802-042 HUMAN PRESCRIPTION DRUG Clindesse clindamycin phosphate CREAM VAGINAL 20150703 NDA NDA050793 Perrigo New York Inc CLINDAMYCIN PHOSPHATE 100 mg/5g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 45802-045_b07ff7e1-0770-4d4b-b775-68c2bd522e21 45802-045 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide AEROSOL, SPRAY TOPICAL 20150417 ANDA ANDA205782 Perrigo New York Inc TRIAMCINOLONE ACETONIDE .147 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-046_ed6716fd-d969-41b0-bcb1-bbf139ff31cd 45802-046 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate OINTMENT TOPICAL 20060710 ANDA ANDA062351 Perrigo New York Inc GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 45802-048_fee7355d-712b-4664-9819-b48d88bfb9e4 45802-048 HUMAN PRESCRIPTION DRUG Nystatin Nystatin OINTMENT TOPICAL 20060915 ANDA ANDA062472 Perrigo New York Inc NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 45802-049_a986cc20-ac47-42e9-b77d-72995bd70468 45802-049 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20061110 ANDA ANDA087385 Perrigo New York Inc TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-050_12dd45a6-395c-46aa-a962-e65d97957efe 45802-050 HUMAN OTC DRUG dibucaine dibucaine OINTMENT TOPICAL 20110620 OTC MONOGRAPH FINAL part346 Perrigo New York Inc DIBUCAINE 1 g/100g N 20181231 45802-053_b37e5a3f-c1c3-4ebf-bb95-30a3ee3d7629 45802-053 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate AEROSOL, FOAM TOPICAL 20130115 ANDA ANDA078337 Perrigo New York Inc BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-054_a986cc20-ac47-42e9-b77d-72995bd70468 45802-054 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20060512 ANDA ANDA087356 Perrigo New York Inc TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-055_a986cc20-ac47-42e9-b77d-72995bd70468 45802-055 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20060804 ANDA ANDA087357 Perrigo New York Inc TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-056_795068ad-0183-44c3-8c56-ab6d9280d89f 45802-056 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate CREAM TOPICAL 20060823 ANDA ANDA062307 Perrigo New York Inc GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 45802-057_d02eb754-b391-4304-81d8-6eabd7bc599a 45802-057 HUMAN OTC DRUG Ibuprofen ibuprofen SUSPENSION ORAL 20140409 ANDA ANDA075217 Perrigo New York Inc IBUPROFEN 50 mg/1.25mL N 20181231 45802-059_8d886b0b-5640-4658-8225-0189c245589e 45802-059 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 20060921 ANDA ANDA062225 Perrigo New York Inc NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 45802-060_5f1b35b5-3791-4a8e-91ba-c4a50f9b403e 45802-060 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20110620 OTC MONOGRAPH FINAL part333B Perrigo New York Inc BACITRACIN 500 [USP'U]/g N 20181231 45802-061_fabfc46c-9e26-4139-b85d-8c6e4a33192b 45802-061 HUMAN OTC DRUG triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20110307 OTC MONOGRAPH FINAL part333B Perrigo New York Inc BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 45802-063_bd38f89c-85fb-4c4c-a599-76adf46d8b21 45802-063 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20061009 ANDA ANDA086415 Perrigo New York Inc TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-064_bd38f89c-85fb-4c4c-a599-76adf46d8b21 45802-064 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20060928 ANDA ANDA086414 Perrigo New York Inc TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-065_bd38f89c-85fb-4c4c-a599-76adf46d8b21 45802-065 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20060517 ANDA ANDA086413 Perrigo New York Inc TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-083_059323b0-1034-4cc3-96b8-31af3c0c6d22 45802-083 HUMAN PRESCRIPTION DRUG Erythromycin-Benzoyl Peroxide erythromycin and benzoyl peroxide KIT 20130507 NDA AUTHORIZED GENERIC NDA050557 Perrigo New York Inc E 20171231 45802-083_4affcac1-7e58-4248-8466-d4b0395fa663 45802-083 HUMAN PRESCRIPTION DRUG Erythromycin-Benzoyl Peroxide erythromycin and benzoyl peroxide KIT 19841026 NDA AUTHORIZED GENERIC NDA050557 Perrigo New York Inc E 20171231 45802-087_f66205f2-4a06-4bb3-9a71-3ce8891fc08c 45802-087 HUMAN PRESCRIPTION DRUG Alogliptin Alogliptin TABLET, FILM COATED ORAL 20160408 NDA AUTHORIZED GENERIC NDA022271 Perrigo New York Inc ALOGLIPTIN BENZOATE 6.25 mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] N 20181231 45802-089_b765570e-e5b5-48e4-b4d2-2a85ac19a2ea 45802-089 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex LOZENGE ORAL 20160708 ANDA ANDA203690 Perrigo New York Inc NICOTINE 2 mg/1 N 20181231 45802-097_f76232ed-b109-43d1-bf2e-d41b6420c37d 45802-097 HUMAN PRESCRIPTION DRUG Estradiol Vaginal Estradiol CREAM VAGINAL 20180131 ANDA ANDA210194 Perrigo New York Inc ESTRADIOL .1 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20191231 45802-098_f58a6339-1143-4798-8daa-9fed6b5636a1 45802-098 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine ENEMA RECTAL 20071011 ANDA ANDA076751 Perrigo New York Inc MESALAMINE 4 g/60mL Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 45802-101_345999ee-d719-4b80-8093-2ba6d52c02b2 45802-101 HUMAN OTC DRUG benzoyl peroxide Benzoyl peroxide GEL TOPICAL 20120313 OTC MONOGRAPH FINAL part333D Perrigo New York Inc BENZOYL PEROXIDE 2.5 g/100g N 20181231 45802-103_f66205f2-4a06-4bb3-9a71-3ce8891fc08c 45802-103 HUMAN PRESCRIPTION DRUG Alogliptin Alogliptin TABLET, FILM COATED ORAL 20160408 NDA AUTHORIZED GENERIC NDA022271 Perrigo New York Inc ALOGLIPTIN BENZOATE 12.5 mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] N 20181231 45802-104_8c5cba2a-2fc0-4208-b940-fb288ff9809b 45802-104 HUMAN PRESCRIPTION DRUG olopatadine hydrochloride Olopatadine Hydrochloride SPRAY NASAL 20170614 ANDA ANDA202853 Perrigo New York Inc OLOPATADINE HYDROCHLORIDE 665 ug/1 Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 45802-105_3171ef31-322c-4098-8b89-1e5fa6975fe1 45802-105 HUMAN OTC DRUG Fluticasone propionate glucocorticoid Fluticasone propionate SPRAY, METERED NASAL 20160825 20180601 ANDA ANDA207957 Perrigo New York Inc FLUTICASONE PROPIONATE 50 ug/1 N 20181231 45802-106_a1b1216b-293e-4a46-b9dc-7dd52c9fd829 45802-106 HUMAN OTC DRUG Loratadine D Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120119 ANDA ANDA076050 Perrigo New York Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 45802-107_9ebb7d09-d10e-4542-9468-e87bcb142357 45802-107 HUMAN OTC DRUG pseudoephedrine hydrochloride Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140524 ANDA ANDA075153 Perrigo New York Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 45802-109_8468115a-4f0c-4ae8-bcd6-38f8b81cf871 45802-109 HUMAN OTC DRUG Triamcinolone Acetonide Nasal Triamcinolone acetonide SPRAY, METERED NASAL 20170328 ANDA ANDA078104 Perrigo New York Inc TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 45802-112_779d7cc3-d871-4366-bcb9-ea6ee40988c8 45802-112 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20091030 ANDA ANDA065123 Perrigo New York Inc MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20191231 45802-116_e4e50858-1080-49c3-8daf-6d87be0bedd6 45802-116 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL TOPICAL 20141227 NDA NDA203098 Perrigo New York Inc TESTOSTERONE 12.5 mg/1.25g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 45802-118_7f0b424f-522e-4fa6-a27d-635851ab6969 45802-118 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate SOLUTION TOPICAL 20081211 ANDA ANDA077180 Perrigo New York Inc MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-119_6a949562-55d9-4c72-9559-8ed99601978c 45802-119 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20080718 ANDA ANDA076067 Perrigo New York Inc MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-124_bb7c80ae-1f33-474a-bd31-46e1227d8d7f 45802-124 HUMAN PRESCRIPTION DRUG hydrocortisone acetate pramoxine HCl Hydrocortisone Acetate, Pramoxine HCl CREAM TOPICAL 20110329 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 2.5; 1 g/100g; g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-129_69090eb8-832b-4b8d-9a32-86b8c2e9ae24 45802-129 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate CREAM TOPICAL 20080804 ANDA ANDA077123 Perrigo New York Inc HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-131_11a533fa-bf42-482d-93b4-a101d34b9785 45802-131 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate OINTMENT TOPICAL 20090205 ANDA ANDA076872 Perrigo New York Inc HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-132_fe3552e1-1360-461e-a9e8-6ea75cfeb3fd 45802-132 HUMAN PRESCRIPTION DRUG fenofibrate fenofibrate TABLET ORAL 20140923 ANDA ANDA090715 Perrigo New York Inc FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 45802-133_0fe928bb-89f4-4894-9380-c85ed4689640 45802-133 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20140409 ANDA ANDA074937 Perrigo New York Inc IBUPROFEN 100 mg/5mL N 20181231 45802-138_269b1931-abd2-45a1-9314-f95761a132a5 45802-138 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine Ciclopirox Olamine CREAM TOPICAL 20060719 ANDA ANDA077364 Perrigo New York Inc CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 45802-140_b9b1072a-8798-4d8f-9fca-b0ae5729390d 45802-140 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20140409 ANDA ANDA074937 Perrigo New York Inc IBUPROFEN 100 mg/5mL N 20181231 45802-141_4ba4938b-32dd-4ed1-b9e2-f1ae4686d647 45802-141 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20070919 ANDA ANDA077623 Perrigo New York Inc CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 45802-143_adf1a41f-101f-4d52-bffc-ec4055d6005d 45802-143 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140520 OTC MONOGRAPH FINAL part333B Perrigo New York Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 45802-144_9eea5875-d153-4bba-aee2-b1d1cd8b5e57 45802-144 HUMAN PRESCRIPTION DRUG hydrocortisone acetate pramoxine hcl hydrocortisone acetate pramoxine hcl CREAM TOPICAL 20100413 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 1; 1 g/100g; g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-150_f66205f2-4a06-4bb3-9a71-3ce8891fc08c 45802-150 HUMAN PRESCRIPTION DRUG Alogliptin Alogliptin TABLET, FILM COATED ORAL 20160408 NDA AUTHORIZED GENERIC NDA022271 Perrigo New York Inc ALOGLIPTIN BENZOATE 25 mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] N 20181231 45802-151_eb2affdb-9774-47fa-a711-12c8cad3878c 45802-151 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140114 ANDA ANDA090256 Perrigo New York Inc FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-169_f0141690-a9c3-49f3-852e-f5c84a0d6eec 45802-169 HUMAN PRESCRIPTION DRUG alogliptin and metformin hydrochloride alogliptin and metformin hydrochloride TABLET, FILM COATED ORAL 20160408 NDA NDA203414 Perrigo New York Inc ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE 12.5; 500 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 45802-174_b5109d5c-7849-46b3-9bd6-44eac11ba556 45802-174 HUMAN OTC DRUG Muscle Rub Menthol, Methyl salicylate CREAM TOPICAL 20110303 OTC MONOGRAPH NOT FINAL part348 Perrigo New York Inc MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g N 20181231 45802-188_43826c68-0a20-460d-a7b5-f3e12395a7d0 45802-188 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131101 OTC MONOGRAPH FINAL part346 Perrigo New York Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 45802-201_cbad0192-eda5-4803-8066-8e3790069361 45802-201 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20140409 OTC MONOGRAPH NOT FINAL part343 Perrigo New York Inc ACETAMINOPHEN 160 mg/5mL N 20181231 45802-203_40cda38f-5903-4cab-8f63-24a4e5c35be3 45802-203 HUMAN OTC DRUG childrens acetaminophen Acetaminophen SUSPENSION ORAL 20140409 OTC MONOGRAPH NOT FINAL part343 Perrigo New York Inc ACETAMINOPHEN 160 mg/5mL N 20181231 45802-206_83080771-8c41-4f36-8802-b5dd615e35e7 45802-206 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20140409 ANDA ANDA078325 Perrigo New York Inc NICOTINE 2 mg/1 N 20181231 45802-210_a388dc49-9b81-4af3-ac9c-7bee5cb37ec7 45802-210 HUMAN PRESCRIPTION DRUG nitroglycerin lingual Nitroglycerin SPRAY ORAL 20130920 ANDA ANDA091496 Perrigo New York Inc NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 45802-211_f0141690-a9c3-49f3-852e-f5c84a0d6eec 45802-211 HUMAN PRESCRIPTION DRUG alogliptin and metformin hydrochloride alogliptin and metformin hydrochloride TABLET, FILM COATED ORAL 20160408 NDA NDA203414 Perrigo New York Inc ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE 12.5; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 45802-216_6e2e9383-db6e-4786-9a7d-682dbfc0a8fc 45802-216 HUMAN OTC DRUG benzoyl peroxide BENZOYL PEROXIDE GEL TOPICAL 20120313 OTC MONOGRAPH FINAL part333D Perrigo New York Inc BENZOYL PEROXIDE 5 g/100g N 20181231 45802-221_a4ec918e-b3a1-46f4-a528-05ff4c2c7833 45802-221 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate OINTMENT TOPICAL 20070709 ANDA ANDA076668 Perrigo New York Inc FLUTICASONE PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-222_c74d6c61-8be0-4de2-b3d2-9e719ff017b1 45802-222 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate CREAM TOPICAL 20060913 ANDA ANDA076793 Perrigo New York Inc FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-230_ca0b6375-6155-49d8-a969-4ff44a7ecd35 45802-230 HUMAN OTC DRUG Guaifenesin and pseudoephedrine hydrochloride Extended Release Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20160129 ANDA ANDA091071 Perrigo New York Inc GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 45802-237_7620ede7-bd65-434f-913e-a3af0ef5aef5 45802-237 HUMAN PRESCRIPTION DRUG Salicylic Acid Salicylic Acid SHAMPOO TOPICAL 20080825 20190101 UNAPPROVED DRUG OTHER Perrigo New York Inc SALICYLIC ACID 6 mg/100mL N 20181231 45802-238_e2413b56-bcc6-4c26-8e18-12b9249fdbbf 45802-238 HUMAN PRESCRIPTION DRUG Alogliptin and Pioglitazone Alogliptin Benzoate and Pioglitazone hydrochloride TABLET, FILM COATED ORAL 20160408 NDA AUTHORIZED GENERIC NDA022426 Perrigo New York Inc ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 12.5; 15 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 45802-244_605540d8-7189-49b9-9e91-572f6b519fae 45802-244 HUMAN PRESCRIPTION DRUG nystatin and triamcinolone acetonide nystatin and triamcinolone acetonide OINTMENT TOPICAL 20171018 ANDA ANDA207380 Perrigo New York Inc NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-245_7e5a93a2-ed9d-42fb-a66f-5f475f9d26de 45802-245 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120807 ANDA ANDA202319 Perrigo New York Inc LANSOPRAZOLE 15 mg/1 N 20181231 45802-257_a2bfb7b7-85b1-4d8c-a8b3-912d2badf34f 45802-257 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20041221 ANDA ANDA076679 Perrigo New York Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-260_e2413b56-bcc6-4c26-8e18-12b9249fdbbf 45802-260 HUMAN PRESCRIPTION DRUG Alogliptin and Pioglitazone Alogliptin Benzoate and Pioglitazone hydrochloride TABLET, FILM COATED ORAL 20160408 NDA AUTHORIZED GENERIC NDA022426 Perrigo New York Inc ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 12.5; 30 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 45802-263_dee4fcc5-3825-47e7-80b7-963e16bea987 45802-263 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin Phosphate SOLUTION TOPICAL 20060531 ANDA ANDA065049 Perrigo New York Inc CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 45802-269_0baa166f-18c3-4933-8e4f-1ec03e4a1b9e 45802-269 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20060811 ANDA ANDA076369 Perrigo New York Inc PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] N 20181231 45802-276_ecb5ffad-7a60-420e-93d1-3d491e42960c 45802-276 HUMAN OTC DRUG hydrocortisone hydrocortisone OINTMENT TOPICAL 20110818 OTC MONOGRAPH NOT FINAL part348 Perrigo New York Inc HYDROCORTISONE 1 g/100g N 20181231 45802-280_1f8a9762-5ef0-4b66-834a-31ca3f55b534 45802-280 HUMAN OTC DRUG benzoyl peroxide BENZOYL PEROXIDE LIQUID TOPICAL 20130124 OTC MONOGRAPH FINAL part333D Perrigo New York Inc BENZOYL PEROXIDE 5 g/100g N 20181231 45802-304_e2413b56-bcc6-4c26-8e18-12b9249fdbbf 45802-304 HUMAN PRESCRIPTION DRUG Alogliptin and Pioglitazone Alogliptin Benzoate and Pioglitazone hydrochloride TABLET, FILM COATED ORAL 20160408 NDA AUTHORIZED GENERIC NDA022426 Perrigo New York Inc ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 12.5; 45 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 45802-308_4af6a75f-4cbe-4600-a4fd-afed8a3da0bd 45802-308 HUMAN OTC DRUG benzoyl peroxide BENZOYL PEROXIDE GEL TOPICAL 20120406 OTC MONOGRAPH FINAL part333D Perrigo New York Inc BENZOYL PEROXIDE 10 g/100g N 20181231 45802-315_fe3552e1-1360-461e-a9e8-6ea75cfeb3fd 45802-315 HUMAN PRESCRIPTION DRUG fenofibrate fenofibrate TABLET ORAL 20140813 ANDA ANDA090715 Perrigo New York Inc FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 45802-318_09150b18-97cc-464f-87e6-c5d488cf563f 45802-318 HUMAN OTC DRUG benzoyl peroxide BENZOYL PEROXIDE LIQUID TOPICAL 20130220 OTC MONOGRAPH FINAL part333D Perrigo New York Inc BENZOYL PEROXIDE 10 g/100g N 20181231 45802-325_3ab0bea1-ba30-4594-b87b-ea06c8f6f42f 45802-325 HUMAN OTC DRUG Guaifenesin Extended Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160125 ANDA ANDA091009 Perrigo New York Inc GUAIFENESIN 1200 mg/1 N 20181231 45802-338_5dbf07d6-46c6-495d-b92a-bd8f4b979b9e 45802-338 HUMAN PRESCRIPTION DRUG hydroquinone time release hydroquinone CREAM TOPICAL 20080424 20181116 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 45802-344_9ffd8e77-006f-4003-bfb4-d7d73627ce1d 45802-344 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex LOZENGE ORAL 20140331 ANDA ANDA077007 Perrigo New York Inc NICOTINE 2 mg/1 N 20181231 45802-351_e2413b56-bcc6-4c26-8e18-12b9249fdbbf 45802-351 HUMAN PRESCRIPTION DRUG Alogliptin and Pioglitazone Alogliptin Benzoate and Pioglitazone hydrochloride TABLET, FILM COATED ORAL 20160408 NDA AUTHORIZED GENERIC NDA022426 Perrigo New York Inc ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 25; 15 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 45802-356_7d86923c-29fe-4cad-8210-a5f49d669e84 45802-356 HUMAN OTC DRUG Trolamine Salicylate Trolamine Salicylate CREAM TOPICAL 20101126 OTC MONOGRAPH NOT FINAL part348 Perrigo New York Inc TROLAMINE SALICYLATE 10 g/100g N 20181231 45802-358_5434ec48-6587-4ed0-9322-efa8e3f4da5d 45802-358 HUMAN OTC DRUG diphenhydramine hcl and zinc acetate Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20051205 OTC MONOGRAPH NOT FINAL part348 Perrigo New York Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 45802-368_42c5b579-35b5-4b82-b2c8-c226e5b1a795 45802-368 HUMAN PRESCRIPTION DRUG Imiquimod Imiquimod CREAM TOPICAL 20101109 ANDA ANDA078837 Perrigo New York Inc IMIQUIMOD 12.5 mg/.25g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] N 20181231 45802-376_75e7033a-15d0-4873-89d7-cb657c179d73 45802-376 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20060928 ANDA ANDA076592 Perrigo New York Inc BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-390_0e7bc961-22c0-4d02-9462-dad9412de8da 45802-390 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus OINTMENT TOPICAL 20141120 NDA NDA050777 Perrigo New York Inc TACROLIMUS .3 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 45802-395_77aa1453-6c05-40f8-97f9-06d486876e99 45802-395 HUMAN OTC DRUG vitamin a and d Lanolin, Petrolatum OINTMENT TOPICAL 20110503 OTC MONOGRAPH FINAL part347 Perrigo New York Inc LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g N 20181231 45802-396_c3c82e4e-d0d6-436b-865c-34535a87e784 45802-396 HUMAN PRESCRIPTION DRUG gynazole 1 butoconazole nitrate CREAM VAGINAL 20150429 ANDA ANDA200923 Perrigo New York Inc BUTOCONAZOLE NITRATE 100 mg/5g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 45802-400_dbd4f19e-c345-4862-9d92-831d052d02bf 45802-400 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine Ciclopirox Olamine SUSPENSION TOPICAL 20061229 ANDA ANDA077676 Perrigo New York Inc CICLOPIROX OLAMINE 7.7 mg/100mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 45802-401_24fd8df2-482d-44e1-a723-f73154136acb 45802-401 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SHAMPOO TOPICAL 20100217 ANDA ANDA078594 Perrigo New York Inc CICLOPIROX 1 g/100mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 45802-402_e2413b56-bcc6-4c26-8e18-12b9249fdbbf 45802-402 HUMAN PRESCRIPTION DRUG Alogliptin and Pioglitazone Alogliptin Benzoate and Pioglitazone hydrochloride TABLET, FILM COATED ORAL 20160408 NDA AUTHORIZED GENERIC NDA022426 Perrigo New York Inc ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 25; 30 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 45802-410_d6317877-39ff-4c94-b6c0-ba057c80b856 45802-410 HUMAN OTC DRUG oxymetazoline hcl oxymetazoline hydrochloride SPRAY NASAL 20051205 OTC MONOGRAPH FINAL part341 Perrigo New York Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 45802-419_4acff82e-10c7-4372-b2d6-c05f930cb78c 45802-419 HUMAN PRESCRIPTION DRUG Ammonium Lactate Ammonium Lactate LOTION TOPICAL 20060620 ANDA ANDA075570 Perrigo New York Inc AMMONIUM LACTATE 12 g/100g N 20181231 45802-422_8974cd07-b3c0-4c40-a5be-fd12a36033c6 45802-422 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 20060411 NDA NDA017010 Perrigo New York Inc DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-423_6896dbf7-8ce2-42be-ae56-f49869aa5943 45802-423 HUMAN PRESCRIPTION DRUG Desonide Desonide OINTMENT TOPICAL 20060822 NDA NDA017426 Perrigo New York Inc DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-425_860876c2-a0ea-4d0d-a746-6253533f93be 45802-425 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 Perrigo New York Inc FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 45802-432_2837f235-7f0c-4c26-a9e6-c25aeb0168ee 45802-432 HUMAN OTC DRUG pseudoephedrine hydrochloride Pseudoephedrine HCl TABLET, FILM COATED ORAL 20081017 OTC MONOGRAPH FINAL part341 Perrigo New York Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 45802-433_8dac1448-d51e-48c7-95bd-87f9f0051cfd 45802-433 HUMAN OTC DRUG dextromethorphan polistirex extended release dextromethorphan polistirex SUSPENSION ORAL 20120910 ANDA ANDA091135 Perrigo New York Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 45802-434_65e30756-4fd0-4f40-a555-f2c12747f6c8 45802-434 HUMAN OTC DRUG clotrimazole Clotrimazole CREAM TOPICAL 20110603 OTC MONOGRAPH FINAL part333C Perrigo New York Inc CLOTRIMAZOLE 1 g/100g N 20181231 45802-437_b3dbeb2e-f51d-4009-9759-5cf2273bcc76 45802-437 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol propionate AEROSOL, FOAM TOPICAL 20080320 ANDA ANDA077763 Perrigo New York Inc CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-438_13430c74-5731-461c-8c11-aa8509517557 45802-438 HUMAN OTC DRUG hydrocortisone Hydrocortisone CREAM TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part348 Perrigo New York Inc HYDROCORTISONE 1 g/100g N 20181231 45802-441_e50ce586-b7a8-4085-a57e-580effc7e64d 45802-441 HUMAN PRESCRIPTION DRUG fluticasone propionate fluticasone propionate LOTION TOPICAL 20130808 ANDA ANDA091553 Perrigo New York Inc FLUTICASONE PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-443_2384b809-a138-4de5-8fa3-36aa7a647655 45802-443 HUMAN OTC DRUG Triamcinolone Acetonide Glucocorticoid Triamcinolone acetonide SPRAY, METERED NASAL 20160817 ANDA ANDA078104 Perrigo New York Inc TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 45802-453_c3d51447-71f4-4f0b-8eff-e250466a98f0 45802-453 HUMAN PRESCRIPTION DRUG Adapalene Adapalene CREAM TOPICAL 20101026 NDA NDA020748 Perrigo New York Inc ADAPALENE .1 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 45802-455_af01d5e9-99a9-415e-baa4-9d8ea7572e98 45802-455 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate CREAM TOPICAL 20091202 ANDA ANDA075666 Perrigo New York Inc HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-465_06dbfe44-c415-4860-944c-1dacd32f28b4 45802-465 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20100119 ANDA ANDA076419 Perrigo New York Inc KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 45802-466_ea4d42e4-193f-471c-9f07-2d0bf4f0ed39 45802-466 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20060808 ANDA ANDA076479 Perrigo New York Inc ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 45802-472_87a4c494-56f9-48f6-8592-d610c507a4fc 45802-472 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate Pramoxine Hcl Hydrocortisone Acetate Pramoxine Hcl CREAM TOPICAL 19960927 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 2.5; 1 g/100g; g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-484_1c053783-bb52-45d6-a7b0-5ee31b1586fc 45802-484 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20140409 OTC MONOGRAPH NOT FINAL part343 Perrigo New York Inc ACETAMINOPHEN 500 mg/1 N 20181231 45802-485_0f029aed-2c29-4ed3-b272-260bca47f5d5 45802-485 HUMAN PRESCRIPTION DRUG Fluocinolone acetonide Fluocinolone acetonide OIL TOPICAL 20170614 ANDA ANDA202848 Perrigo New York Inc FLUOCINOLONE ACETONIDE .01 mg/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-486_de26b0f8-0b65-41c1-8d48-509cff5b6d86 45802-486 HUMAN OTC DRUG Docusate Sodium Docusate sodium CAPSULE, LIQUID FILLED ORAL 20081028 OTC MONOGRAPH NOT FINAL part334 Perrigo New York Inc DOCUSATE SODIUM 100 mg/1 N 20181231 45802-490_cdb60f74-ce23-4015-90eb-b23a2275f6cb 45802-490 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140411 ANDA ANDA074661 Perrigo New York Inc NAPROXEN SODIUM 220 mg/1 N 20181231 45802-493_bd31ffd7-75a2-4f0e-9734-55ab6e841386 45802-493 HUMAN PRESCRIPTION DRUG Ammonium Lactate Ammonium Lactate CREAM TOPICAL 20060816 ANDA ANDA075774 Perrigo New York Inc AMMONIUM LACTATE 12 g/100g N 20181231 45802-495_f9254569-26be-42e3-9de2-ad7e050f6729 45802-495 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 20061024 ANDA ANDA076510 Perrigo New York Inc DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-496_23d0652f-367c-4d60-ac53-c70a277fc124 45802-496 HUMAN PRESCRIPTION DRUG desoximetasone Desoximetasone OINTMENT TOPICAL 20150514 ANDA ANDA077770 Perrigo New York Inc DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-499_e2413b56-bcc6-4c26-8e18-12b9249fdbbf 45802-499 HUMAN PRESCRIPTION DRUG Alogliptin and Pioglitazone Alogliptin Benzoate and Pioglitazone hydrochloride TABLET, FILM COATED ORAL 20160408 NDA AUTHORIZED GENERIC NDA022426 Perrigo New York Inc ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 25; 45 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 45802-507_1144d82f-085c-45a4-b32d-9b24c495d154 45802-507 HUMAN PRESCRIPTION DRUG clindamycin and benzoyl peroxide clindamycin and benzoyl peroxide KIT 20160426 ANDA ANDA202440 Perrigo New York Inc N 20181231 45802-507_4972378f-3d4c-4623-ba0e-3a46f8125121 45802-507 HUMAN PRESCRIPTION DRUG clindamycin and benzoyl peroxide clindamycin and benzoyl peroxide KIT 20150922 ANDA ANDA202440 Perrigo New York Inc N 20181231 45802-507_9cba4e83-64b0-43b6-a337-cd0fd4744d31 45802-507 HUMAN PRESCRIPTION DRUG clindamycin and benzoyl peroxide clindamycin and benzoyl peroxide KIT 20150922 ANDA ANDA202440 Perrigo New York Inc N 20181231 45802-507_dcc01e01-b2c7-40a0-8813-c76583630b7a 45802-507 HUMAN PRESCRIPTION DRUG clindamycin and benzoyl peroxide clindamycin and benzoyl peroxide KIT 20160505 ANDA ANDA202440 Perrigo New York Inc N 20181231 45802-532_4ab17031-4603-4be2-9d45-2abf27074d53 45802-532 HUMAN PRESCRIPTION DRUG ketoconazole ketoconazole AEROSOL, FOAM TOPICAL 20110830 ANDA ANDA091550 Perrigo New York Inc KETOCONAZOLE 2 g/100g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 45802-562_7d3574d3-9fe8-4c12-9254-a8d9dcdc1c9b 45802-562 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin Phosphate SOLUTION TOPICAL 20130917 ANDA ANDA064050 Perrigo New York Inc CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 45802-571_3106e777-54d1-4fd8-b414-3deab09e6a12 45802-571 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 Perrigo New York Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 45802-580_f910c1ab-1905-4881-ae76-e979387b19c4 45802-580 HUMAN PRESCRIPTION DRUG Scopolamine Trandermal System scolopamine transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20170613 ANDA ANDA078830 Perrigo New York Inc SCOPOLAMINE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 45802-594_f90fa1ec-599e-4312-b94f-ccb76a9e0cab 45802-594 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride levocetirizine dihydrochloride TABLET ORAL 20101126 ANDA ANDA090229 Perrigo New York Inc LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 45802-608_fe175b5a-fb78-48fc-bd83-12177d86d6b8 45802-608 HUMAN PRESCRIPTION DRUG calcitriol calcitriol OINTMENT TOPICAL 20120308 NDA NDA022087 Perrigo New York Inc CALCITRIOL 3 ug/g Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 45802-610_3a15d84a-05eb-4b8b-8a56-cc74a50fa8f7 45802-610 HUMAN PRESCRIPTION DRUG testosterone testosterone SOLUTION TOPICAL 20170628 ANDA ANDA204255 Perrigo New York Inc TESTOSTERONE 30 mg/1.5mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 45802-626_2420b17e-0619-42e8-81ae-245cc0e8ec5b 45802-626 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine hydrochloride SOLUTION ORAL 20080724 ANDA ANDA078398 Perrigo New York Inc CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 45802-637_74dbe844-4825-4670-b985-53611583e965 45802-637 HUMAN PRESCRIPTION DRUG clobetasol propionate emollient formulation clobetasol propionate AEROSOL, FOAM TOPICAL 20130201 ANDA ANDA201402 Perrigo New York Inc CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-650_ccf00151-a202-41e7-8abe-4df13841b122 45802-650 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Perrigo New York Inc LORATADINE 10 mg/1 N 20181231 45802-660_92f7ea81-fc0c-4586-98a7-a6aa6ba5e0a1 45802-660 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate clindamycin phosphate AEROSOL, FOAM TOPICAL 20100331 ANDA ANDA090785 Perrigo New York Inc CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 45802-680_4b2e6419-4eb9-47fb-8b9c-8316b10e6f8d 45802-680 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride Levocetirizine dihydrochloride SOLUTION ORAL 20111107 ANDA ANDA091263 Perrigo New York Inc LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 45802-700_0e7bc961-22c0-4d02-9462-dad9412de8da 45802-700 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus OINTMENT TOPICAL 20141120 NDA NDA050777 Perrigo New York Inc TACROLIMUS 1 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 45802-717_4330f38d-1972-465f-8a73-0b106d6176f0 45802-717 HUMAN PRESCRIPTION DRUG Terconazole Terconazole SUPPOSITORY VAGINAL 20060828 ANDA ANDA077149 Perrigo New York Inc TERCONAZOLE 80 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 45802-721_80deb89f-d9d6-4e3e-9177-21320827f007 45802-721 HUMAN OTC DRUG Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080410 ANDA ANDA077170 Perrigo New York Inc CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 45802-730_96eab1b5-11f9-4ce8-a28e-7df704a8cf83 45802-730 HUMAN OTC DRUG acetaminophen pain reliever fever reducer Acetaminophen SUPPOSITORY RECTAL 20101028 ANDA ANDA070608 Perrigo New York Inc ACETAMINOPHEN 650 mg/1 N 20181231 45802-732_ae6994f1-e619-431b-8b5b-ea4bbf52bd4f 45802-732 HUMAN OTC DRUG acetaminophen for children Acetaminophen SUPPOSITORY RECTAL 20101214 ANDA ANDA070607 Perrigo New York Inc ACETAMINOPHEN 120 mg/1 N 20181231 45802-736_f1d946f4-0e08-4610-90a1-9f57c6091351 45802-736 HUMAN PRESCRIPTION DRUG clindamycin phosphate and benzoyl peroxide Clindamycin, Benzoyl Peroxide GEL TOPICAL 20120626 ANDA ANDA090979 Perrigo New York Inc CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE 10; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 45802-758_b099d0e7-19b7-4cb6-b760-f19f7a64d88f 45802-758 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20060627 ANDA ANDA040500 Perrigo New York Inc PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 45802-759_b099d0e7-19b7-4cb6-b760-f19f7a64d88f 45802-759 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20060517 ANDA ANDA040500 Perrigo New York Inc PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 45802-806_694359b0-f5da-43ef-86a6-3e3abaa0b0a0 45802-806 HUMAN PRESCRIPTION DRUG salicylic acid Salicylic Acid CREAM TOPICAL 20070907 20180601 UNAPPROVED DRUG OTHER Perrigo New York Inc SALICYLIC ACID 6 g/100g N 20181231 45802-818_694359b0-f5da-43ef-86a6-3e3abaa0b0a0 45802-818 HUMAN PRESCRIPTION DRUG salicylic acid Salicylic Acid LOTION TOPICAL 20070927 20190101 UNAPPROVED DRUG OTHER Perrigo New York Inc SALICYLIC ACID 6 mg/100mL N 20181231 45802-846_9dbe0978-9345-47e0-a7f8-7ae53cfa4c3f 45802-846 HUMAN PRESCRIPTION DRUG adapalene and benzoyl peroxide Adapalene and Benzoyl Peroxide GEL TOPICAL 20180124 ANDA ANDA205033 Perrigo New York Inc ADAPALENE; BENZOYL PEROXIDE .1; 2.5 g/100g; g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 45802-868_47e95092-c222-484d-85eb-62f3ccea7c2e 45802-868 HUMAN OTC DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091013 ANDA ANDA090685 Perrigo New York Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 45802-873_67011aad-0d04-4c4b-b564-c02b8d932bc8 45802-873 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex LOZENGE ORAL 20140331 ANDA ANDA077007 Perrigo New York Inc NICOTINE 4 mg/1 N 20181231 45802-880_6f2fa5dc-952d-49d5-84ad-899a06a59b84 45802-880 HUMAN PRESCRIPTION DRUG NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin, triamcinolone acetonide CREAM TOPICAL 20171127 ANDA ANDA208479 Perrigo New York Inc NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-887_803dc223-543a-4b99-9c5a-7eeeee9683a4 45802-887 HUMAN PRESCRIPTION DRUG fluocinolone acetonide fluocinolone acetonide OIL TOPICAL 20170614 ANDA ANDA202847 Perrigo New York Inc FLUOCINOLONE ACETONIDE .01 mg/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-888_1ae2665c-8858-49c0-af11-c207f402e6d9 45802-888 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080225 NDA NDA022032 Perrigo New York Inc OMEPRAZOLE 20 mg/1 N 20181231 45802-896_6e55840a-606e-4f56-acdb-a53e0d72f5bc 45802-896 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium LOTION TOPICAL 20121017 ANDA ANDA078649 Perrigo New York Inc SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 45802-897_173e4d71-b3a5-43f7-aa02-b603311a7150 45802-897 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION ORAL 20111117 ANDA ANDA074937 Perrigo New York Inc IBUPROFEN 100 mg/5mL N 20181231 45802-919_84295d4c-0d2b-426f-abab-e15d211d2a9e 45802-919 HUMAN OTC DRUG cetirizine hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA078336 Perrigo New York Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 45802-923_2f8ec78c-dc73-445c-a967-a29a12d26290 45802-923 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine KIT 20090901 ANDA ANDA076751 Perrigo New York Inc N 20181231 45802-923_eb5bcaab-0f86-4817-9373-0a5e5e1982d2 45802-923 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine KIT 20100217 ANDA ANDA076751 Perrigo New York Inc N 20181231 45802-925_6057fcfd-918d-4e31-8680-bca3dea00442 45802-925 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol propionate GEL TOPICAL 20080730 ANDA ANDA075027 Perrigo New York Inc CLOBETASOL PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-928_d8a48cf7-96ef-4ed9-b6d6-74670f66a825 45802-928 HUMAN PRESCRIPTION DRUG Flurandrenolide Flurandrenolide LOTION TOPICAL 20161006 ANDA ANDA207133 Perrigo New York Inc FLURANDRENOLIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-930_4c2db966-1b5b-4762-99f9-4c3f94df4975 45802-930 HUMAN PRESCRIPTION DRUG hydrocortisone Iodoquinol Hydrocortisone, Iodoquinol CREAM TOPICAL 20080714 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROCORTISONE; IODOQUINOL 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 45802-937_20a6e67d-f8ec-48f8-9940-7cd169bd549d 45802-937 HUMAN PRESCRIPTION DRUG hydrocortisone hydrocortisone LOTION TOPICAL 20080523 ANDA ANDA089074 Perrigo New York Inc HYDROCORTISONE 25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-939_0b229ef5-5e4b-4a31-9cc6-7693c672f8c6 45802-939 HUMAN PRESCRIPTION DRUG Seb Prev Wash Sodium Sulfacetamide LIQUID TOPICAL 20080725 20180930 UNAPPROVED DRUG OTHER Perrigo New York Inc SULFACETAMIDE SODIUM 100 mg/.95mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 45802-952_14a7cf20-cd5d-4eda-bd79-07c78e7117d0 45802-952 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20041208 ANDA ANDA076925 Perrigo New York Inc IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 45802-957_f6cc8d50-2d8d-4ed4-930a-a2479b1ebffe 45802-957 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex LOZENGE ORAL 20160708 ANDA ANDA203690 Perrigo New York Inc NICOTINE 4 mg/1 N 20181231 45802-961_a89b84da-c352-4fd0-9155-85a3acec49fe 45802-961 HUMAN PRESCRIPTION DRUG clobetasol propionate Clobetasol Propionate SHAMPOO TOPICAL 20120810 ANDA ANDA090974 Perrigo New York Inc CLOBETASOL PROPIONATE .05 g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45802-962_0c77c8df-3dac-4a7a-abea-71884137e216 45802-962 HUMAN PRESCRIPTION DRUG Ery Erythromycin SOLUTION TOPICAL 20080707 ANDA ANDA064126 Perrigo New York Inc ERYTHROMYCIN .8 mL/100mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 45802-966_483d6734-f1b5-4fe0-8146-a83d32af44a7 45802-966 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin GEL TOPICAL 20080612 ANDA ANDA063211 Perrigo New York Inc ERYTHROMYCIN 20 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 45802-974_0e535fdf-3ca2-4bd2-84d4-05eb94e4fc82 45802-974 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride SOLUTION ORAL 20080415 ANDA ANDA090254 Perrigo New York Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 45802-980_ebc6a9f0-40ad-4adf-8617-b3305b03e24d 45802-980 HUMAN PRESCRIPTION DRUG Hydroquinone Hydroquinone CREAM TOPICAL 20080617 20181121 UNAPPROVED DRUG OTHER Perrigo New York Inc HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 45802-989_8278b05c-8b52-4c26-a56e-c3eb6d9e96ca 45802-989 HUMAN PRESCRIPTION DRUG Calcipotriene and Betamethasone Dipropionate calcipotriene and betamethasone dipropionate OINTMENT TOPICAL 20080601 NDA AUTHORIZED GENERIC NDA021852 Perrigo New York Inc CALCIPOTRIENE HYDRATE; BETAMETHASONE DIPROPIONATE 50; .5 ug/g; mg/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45861-001_616902a3-a716-6948-e053-2a91aa0a469a 45861-001 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 5; .0375 g/100g; g/100g; g/100g N 20181231 45861-004_61691f99-73e6-e897-e053-2991aa0a3411 45861-004 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN PATCH TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 5; .0375 g/100g; g/100g; g/100g N 20181231 45861-005_0464d781-fa9d-442a-a7a7-94a3c8cf4786 45861-005 HUMAN PRESCRIPTION DRUG Medrox-Rx methyl salicylate, menthol, capsaicin OINTMENT TOPICAL 20111027 OTC MONOGRAPH FINAL part348 Pharmaceutica North America, Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 24; 8.4; .6 g/120g; g/120g; g/120g E 20171231 45861-006_61693dd4-19d2-40e9-e053-2a91aa0ae8db 45861-006 HUMAN OTC DRUG Endoxcin LIDOCAINE HYDROCHLORIDE and Menthol PATCH TOPICAL 20140505 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g N 20181231 45861-009_a72be0bf-0af3-4635-9cc8-6cb28252c683 45861-009 HUMAN OTC DRUG Medrox Menthol, CAPSAICIN, methyl salicylate PATCH TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America, Inc. MENTHOL; CAPSAICIN; METHYL SALICYLATE 5; .0375; 5 g/100g; g/100g; g/100g E 20171231 45861-009_c7f9ca4a-b147-454f-86b5-29bed05500a4 45861-009 HUMAN OTC DRUG Medrox Menthol, CAPSAICIN, methyl salicylate PATCH TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America, Inc. MENTHOL; CAPSAICIN; METHYL SALICYLATE 5; .0375; 5 g/100g; g/100g; g/100g E 20171231 45861-011_b7de5c70-4b14-4f5c-b1ca-b8e73be4de01 45861-011 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120809 ANDA ANDA090705 Pharmaceutica North America, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 45861-014_61698cd9-c343-a6a3-e053-2a91aa0a977f 45861-014 HUMAN OTC DRUG MEDROX MENTHOL, CAPSAICIN PATCH TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g N 20181231 45861-016_61699f20-6945-3963-e053-2991aa0a819e 45861-016 HUMAN OTC DRUG LenzaGel LIDOCAINE HYDROCHLORIDE, MENTHOL GEL TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g N 20181231 45861-017_1fb6fe1f-2d2a-47ce-ac4f-29d8b99ed834 45861-017 HUMAN OTC DRUG LenzaPatch LIDOCAINE HYDROCHLORIDE, MENTHOL LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Pharmaceutica North America, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g N 20181231 45861-061_303ff0d2-b320-4cb1-95dc-f6e189a43659 45861-061 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20150813 ANDA ANDA086724 Pharmaceutica North America, Inc LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 45861-062_7cab095e-8699-4703-9a42-9c58f2a66c80 45861-062 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20150813 ANDA ANDA203818 Pharmaceutica North America, Inc DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 45861-063_cc352589-8d6a-4b2b-b225-fbba5a2a4555 45861-063 HUMAN PRESCRIPTION DRUG Diclofenac sodium diclofenac sodium GEL TOPICAL 20160428 ANDA ANDA206298 Pharmaceutica North America, Inc DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 45861-064_ca010ed8-018b-4ad4-a378-e7f92406aeb9 45861-064 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20160202 ANDA ANDA200734 Pharmaceutica North America, Inc FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45861-065_32316002-893d-07ed-e054-00144ff88e88 45861-065 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20160506 ANDA ANDA086724 Pharmaceutica North America, Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 45861-066_328139c5-cfd7-5806-e054-00144ff8d46c 45861-066 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20160510 ANDA ANDA203818 Pharmaceutica North America, Inc DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 45861-067_38022679-1ed6-0cc4-e054-00144ff8d46c 45861-067 HUMAN PRESCRIPTION DRUG Diclofenac sodium diclofenac sodium GEL TOPICAL 20160617 ANDA ANDA206298 Pharmaceutica North America, Inc. DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 45861-100_4f2022e4-823d-4378-a63a-9caabea86b0a 45861-100 HUMAN PRESCRIPTION DRUG Gabapentin Kit GABAPENTIN KIT 20120828 ANDA ANDA090705 Pharmaceutica North America, Inc. N 20181231 45861-107_c6af6fb2-637b-4fa2-8941-7ed78b4eb51a 45861-107 HUMAN PRESCRIPTION DRUG Active-Medicated specimen collection kit Urine specimen collection kit KIT 20131031 ANDA ANDA078010 Pharmaceutica North America, Inc E 20171231 45861-108_79cfe36c-07d3-4f42-9118-609b9a22d693 45861-108 HUMAN PRESCRIPTION DRUG ACTIVE-PAC with Gabapentin GABAPENTIN, LIDOCAINE HYDROCHLORIDE, MENTHOL KIT 20140618 ANDA ANDA077242 Pharmaceutica North America, Inc. E 20171231 45861-111_9e916b9d-b233-44e1-ac33-5acf741611fe 45861-111 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20140212 ANDA ANDA077242 Pharmaceutica North America, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 45861-201_616acebf-db64-d685-e053-2a91aa0ab8dd 45861-201 HUMAN OTC DRUG Docuprene DOCUSATE SODIUM TABLET ORAL 20100616 OTC MONOGRAPH NOT FINAL part334 Pharmaceutica North America, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 45865-342_4c9c1111-c13e-42fc-9c1d-5f9c54c86515 45865-342 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20081217 ANDA ANDA075576 Medsource Pharmaceuticals OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 45865-347_62717c61-b047-49f2-ab29-a852dc5dead2 45865-347 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Medsource Pharmaceuticals GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 45865-348_db154152-f820-455d-a524-34591ca94e87 45865-348 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20081208 ANDA ANDA076286 Medsource Pharmaceuticals TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 45865-351_1c6ea763-40f1-0cc9-e054-00144ff8d46c 45865-351 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Medsource Pharmaceuticals NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 45865-352_1d382246-ee7c-69cc-e054-00144ff8d46c 45865-352 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20120913 ANDA ANDA200243 Medsource Pharmaceuticals BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 45865-356_1d382246-eec9-69cc-e054-00144ff8d46c 45865-356 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Medsource Pharmaceuticals GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 45865-357_1b439a3a-319a-43fd-e054-00144ff88e88 45865-357 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20140214 ANDA ANDA091498 Medsource Pharmaceuticals TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 45865-363_1d38a57b-9470-0776-e054-00144ff8d46c 45865-363 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET ORAL 20000215 ANDA ANDA040327 Medsource Pharmaceuticals ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 45865-364_f4dc2502-bb11-4c1d-a67d-67ea7785749c 45865-364 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Extended-Release Diclofenac Sodium TABLET, EXTENDED RELEASE ORAL 20090105 ANDA ANDA075910 Medsource Pharmaceuticals DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 45865-369_1d492b0e-d09f-65c4-e054-00144ff88e88 45865-369 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Medsource Pharmaceuticals BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 45865-373_b988f226-d4a8-4fa3-bea3-5f88462613b0 45865-373 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Medsource Pharmaceuticals IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 45865-374_1d6161e3-2dda-5446-e054-00144ff8d46c 45865-374 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20110715 ANDA ANDA090618 Medsource Pharmaceuticals NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 45865-382_1d6161e3-2e4f-5446-e054-00144ff8d46c 45865-382 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Medsource Pharmaceuticals MIRTAZAPINE 15 mg/1 N 20181231 45865-386_d78e34e6-d2eb-4bfa-8a9f-5f5768345599 45865-386 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20090105 ANDA ANDA076286 Medsource Pharmaceuticals TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 45865-402_1d631948-6492-7270-e054-00144ff88e88 45865-402 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19970605 ANDA ANDA074821 Medsource Pharmaceuticals TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 45865-407_feab4bc9-ea2d-41fe-bf5e-99c2897df8b6 45865-407 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA089160 Medsource Pharmaceuticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 45865-408_1b555b06-0da8-24c0-e054-00144ff8d46c 45865-408 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 Medsource Pharmaceuticals CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 45865-411_1e13cbb2-936a-4919-e054-00144ff8d46c 45865-411 HUMAN PRESCRIPTION DRUG HYDROCODONE BIT/APAP HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20110701 ANDA ANDA040400 Medsource Pharmaceuticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 45865-412_06640c94-07e3-42ea-ace5-2753b4295c33 45865-412 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040754 Medsource Pharmaceuticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 650 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 45865-413_1b65880c-3eac-4d7f-e054-00144ff88e88 45865-413 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Medsource Pharmaceuticals ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 45865-416_1d733324-93c7-201c-e054-00144ff88e88 45865-416 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Medsource Pharmaceuticals RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 45865-418_1d73e25f-69e6-3845-e054-00144ff8d46c 45865-418 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091568 Medsource Pharmaceuticals AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 45865-419_1e171e42-6084-4873-e054-00144ff88e88 45865-419 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Medsource Pharmaceticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 45865-424_1b66047b-478c-4808-e054-00144ff8d46c 45865-424 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20080925 ANDA ANDA078491 Medsource Pharmaceuticals ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 45865-426_0f799403-4e92-4119-a37b-ca4089437fb1 45865-426 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20091201 ANDA ANDA077918 Medsource Pharmaceuticals MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 45865-428_1d73e25f-6a62-3845-e054-00144ff8d46c 45865-428 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Medsource Pharmaceuticals CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 45865-432_1db11285-b9c8-5060-e054-00144ff8d46c 45865-432 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Medsource Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 45865-433_1db200b7-75d3-5e17-e054-00144ff8d46c 45865-433 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 ANDA ANDA090478 Medsource Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 45865-441_1dc2b41e-97c6-415b-e054-00144ff8d46c 45865-441 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Medsource Pharmaceuticals RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 45865-444_1dc3070b-c6ef-4dc0-e054-00144ff8d46c 45865-444 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19860710 ANDA ANDA062676 Medsource Pharmaceuticals DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 45865-445_1dc38234-be66-6be1-e054-00144ff88e88 45865-445 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA090365 Medsource Pharmaceuticals FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 45865-446_1dd4ffa6-c1d4-32d2-e054-00144ff8d46c 45865-446 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20111128 ANDA ANDA202170 Medsource Pharmaceuticals FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 45865-451_f25a460e-1569-4af3-ac4a-b99f44c51313 45865-451 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20090609 ANDA ANDA075465 Medsource Pharmaceuticals FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 45865-464_1dd7b8f4-a298-1c48-e054-00144ff88e88 45865-464 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Medsource Pharmaceuticals NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 45865-469_1b67c155-5a0e-2202-e054-00144ff8d46c 45865-469 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Medsource Pharmaceuticals TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 45865-471_1e2a799d-da6b-0bf1-e054-00144ff8d46c 45865-471 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Medsource Pharmaceuticals CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 45865-474_1ddb2839-218b-2176-e054-00144ff88e88 45865-474 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Medsource Pharmaceuticals IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 45865-498_1e3d9001-2d0b-2c2e-e054-00144ff8d46c 45865-498 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Medsource Pharmaceuticals GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 45865-518_1ea7e83b-e285-17f7-e054-00144ff8d46c 45865-518 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Medsource Pharmaceuticals SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 45865-519_1ea7e83b-e28c-17f7-e054-00144ff8d46c 45865-519 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070801 ANDA ANDA078314 Medsource Pharmaceuticals NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 45865-521_1b67c155-5a71-2202-e054-00144ff8d46c 45865-521 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Medsource Pharmaceuticals ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 45865-536_1eb8084b-68e2-3178-e054-00144ff88e88 45865-536 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 Medsource Pharmaceuticals AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 45865-542_1eb84981-b5b0-4cfd-e054-00144ff88e88 45865-542 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130115 ANDA ANDA086988 Medsource Pharmaceuticals METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 45865-563_1eb89f6e-6e02-5812-e054-00144ff88e88 45865-563 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Medsource Pharmaceuticals ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 45865-570_1ecbd827-e22c-113d-e054-00144ff8d46c 45865-570 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Medsource Pharmaceuticals SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 45865-573_1eceef06-af6b-1065-e054-00144ff8d46c 45865-573 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Medsource Pharmaceuticals DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 45865-574_60cda147-7683-074a-e053-2a91aa0ab9e8 45865-574 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 20180629 ANDA ANDA090937 Medsource Pharmaceuticals GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 45865-575_1edec3f0-b6ca-1c0f-e054-00144ff8d46c 45865-575 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Medsource Pharmaceuticals CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 45865-598_1edf01f7-8cc2-6616-e054-00144ff88e88 45865-598 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Medsource Pharmaceuticals ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 45865-602_1f7ce4bf-88d5-11eb-e054-00144ff88e88 45865-602 HUMAN PRESCRIPTION DRUG Fluticasone Fluticasone Propionate SPRAY, METERED NASAL 20120109 ANDA ANDA078492 Medsource Pharmaceuticals FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45865-605_1e171e42-6084-4873-e054-00144ff88e88 45865-605 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Medsource Pharmaceticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 45865-610_1f7d2f11-5b63-1c90-e054-00144ff88e88 45865-610 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Medsource Pharmaceuticals NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 45865-615_1f7dd809-74ab-366f-e054-00144ff8d46c 45865-615 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 Medsource Pharmaceuticals CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 45865-617_1f7dd809-74b1-366f-e054-00144ff8d46c 45865-617 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 Medsource Pharmaceuticals AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 45865-622_1f7fd914-08ef-664e-e054-00144ff88e88 45865-622 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071221 ANDA ANDA077056 Medsource Pharmaceuticals PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 45865-632_1f7fd914-0979-664e-e054-00144ff88e88 45865-632 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090501 ANDA ANDA077415 Medsource Pharmaceuticals BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 45865-638_1f7fd914-09b4-664e-e054-00144ff88e88 45865-638 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Medsource Pharmaceuticals PREDNISONE 5 mg/1 N 20181231 45865-643_1f80aef4-3ca8-42ec-e054-00144ff8d46c 45865-643 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA AUTHORIZED GENERIC NDA020699 Medsource Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 45865-647_1f80aef4-3ca8-42ec-e054-00144ff8d46c 45865-647 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA AUTHORIZED GENERIC NDA020699 Medsource Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 45865-653_1b68bd67-65d0-4c64-e054-00144ff8d46c 45865-653 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20110607 ANDA ANDA090871 Medsource Pharmaceuticals ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 45865-662_1f908b73-d7c8-4c6f-e054-00144ff8d46c 45865-662 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Medsource Pharmaceuticals BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 45865-670_1f908a83-f50f-2f19-e054-00144ff88e88 45865-670 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Medsource Pharmaceuticals PREDNISONE 10 mg/1 N 20181231 45865-672_1f908b73-d82a-4c6f-e054-00144ff8d46c 45865-672 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 19940511 ANDA ANDA064048 Medsource Pharmaceuticals GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 45865-684_1f919c57-4ae3-6f17-e054-00144ff88e88 45865-684 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Medsource Pharmaceuticals LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 45865-685_1f915bbb-93a2-6cfd-e054-00144ff8d46c 45865-685 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20110829 ANDA ANDA078722 Medsource Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 45865-696_1b7f4459-15d9-1051-e054-00144ff8d46c 45865-696 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19950103 ANDA ANDA074342 Medsource Pharmaceuticals ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 45865-709_1bbd525e-be02-310d-e054-00144ff88e88 45865-709 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120314 NDA NDA022370 Medsource Pharmaceuticals TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 45865-710_1fbe6b78-80d3-223b-e054-00144ff88e88 45865-710 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070614 ANDA ANDA076345 Medsource Pharmaceuticals GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 45865-721_1fc12db9-6562-509b-e054-00144ff88e88 45865-721 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20080320 ANDA ANDA077689 Medsource Pharmaceuticals CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 45865-722_1fc12db9-6581-509b-e054-00144ff88e88 45865-722 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20031107 ANDA ANDA065085 Medsource Pharmaceuticals MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 45865-725_60ce32de-22ca-6a26-e053-2a91aa0a67f9 45865-725 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20120401 20180430 ANDA ANDA088042 Medsource Pharmaceuticals TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45865-747_1ff68ace-8d62-64f5-e054-00144ff88e88 45865-747 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Medsource Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 45865-758_205d5ba3-4139-0b27-e054-00144ff8d46c 45865-758 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Medsource Pharmaceuticals LEVOFLOXACIN 500 mg/1 N 20181231 45865-772_205dc274-ff96-05ac-e054-00144ff88e88 45865-772 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 Medsource Pharmaceuticals CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 45865-775_205dc274-ffcb-05ac-e054-00144ff88e88 45865-775 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Medsource Pharmaceuticals DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 45865-798_205dfd31-09b8-0a48-e054-00144ff88e88 45865-798 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Medsource Pharmaceuticals METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 45865-813_2084fc8f-b9fa-65e2-e054-00144ff8d46c 45865-813 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20140618 ANDA ANDA090723 Medsource Pharmaceuticals DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 45865-816_2084fc8f-b9fa-65e2-e054-00144ff8d46c 45865-816 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20140618 ANDA ANDA090723 Medsource Pharmaceuticals DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 45865-825_2086f746-f922-1af1-e054-00144ff88e88 45865-825 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA200482 Medsource Pharmaceuticals RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 45865-828_1bbd525e-be07-310d-e054-00144ff88e88 45865-828 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Medsource Pharmaceuticals ESZOPICLONE 3 mg/1 CIV N 20181231 45865-829_1bbd525e-be07-310d-e054-00144ff88e88 45865-829 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Medsource Pharmaceuticals ESZOPICLONE 2 mg/1 CIV N 20181231 45865-830_1bbd525e-be07-310d-e054-00144ff88e88 45865-830 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Medsource Pharmaceuticals ESZOPICLONE 1 mg/1 CIV N 20181231 45865-839_60ce2412-fe4a-2e04-e053-2991aa0a2a3d 45865-839 HUMAN PRESCRIPTION DRUG POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate SOLUTION/ DROPS OPHTHALMIC 19970429 20180228 NDA AUTHORIZED GENERIC NDA050567 Medsource Pharmaceuticals POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 45865-840_2087ead6-69b4-5f5a-e054-00144ff8d46c 45865-840 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Medsource Pharmaceuticals CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 45865-845_209b629d-e461-61b1-e054-00144ff8d46c 45865-845 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961111 ANDA ANDA070848 Medsource Pharmaceuticals SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 45865-846_60ce1716-0d86-1b94-e053-2a91aa0a974f 45865-846 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 20181031 ANDA ANDA077802 Medsource Pharmaceuticals OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 45865-849_209ea823-e813-7269-e054-00144ff8d46c 45865-849 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Medsource Pharmaceuticals DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 45865-860_20c699bc-0cef-5984-e054-00144ff88e88 45865-860 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 Medsource Pharmaceuticals OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 45932-0023_ada0b3ec-6b19-49f0-858b-4c91032aef03 45932-0023 HUMAN PRESCRIPTION DRUG Colistimethate colistimethate sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20121122 ANDA ANDA205356 Xellia Pharmaceuticals ApS COLISTIMETHATE 150 mg/2mL N 20181231 45932-0026_c0d7bd10-891a-4ebc-b6c6-9220813d3b01 45932-0026 HUMAN PRESCRIPTION DRUG BACITRACIN BACITRACIN INJECTION INTRAMUSCULAR 20130131 ANDA ANDA203177 Xellia Pharmaceuticals ApS BACITRACIN 50000 [iU]/1 Decreased Cell Wall Synthesis & Repair [PE] N 20181231 45932-0027_9fa8b06d-a006-420c-93cb-89053b1564a1 45932-0027 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION INTRAVENOUS 20140410 ANDA ANDA205685 Xellia Pharmaceuticals ApS TOBRAMYCIN SULFATE 1200 mg/30mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 45932-0028_f678483a-285a-4880-acb8-d934a4cf5d43 45932-0028 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140410 ANDA ANDA091377 Xellia Pharmaceuticals, ApS VANCOMYCIN HYDROCHLORIDE 500 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 45932-0029_f678483a-285a-4880-acb8-d934a4cf5d43 45932-0029 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140410 ANDA ANDA091377 Xellia Pharmaceuticals, ApS VANCOMYCIN HYDROCHLORIDE 1 g/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 45932-0030_5039c2fa-cc43-4787-933c-a9943ca381eb 45932-0030 HUMAN PRESCRIPTION DRUG POLYMYXIN B POLYMYXIN B SULFATE INJECTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20140124 ANDA ANDA202766 Xellia Pharmaceuticals ApS POLYMYXIN B SULFATE 500000 1/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 45932-0031_ed462f6b-158d-4b97-92d0-8b91bef31132 45932-0031 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION INTRAVENOUS 20150210 ANDA ANDA206243 Xellia Pharmaceuticals ApS VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 45932-0032_ed462f6b-158d-4b97-92d0-8b91bef31132 45932-0032 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION INTRAVENOUS 20150210 ANDA ANDA206243 Xellia Pharmaceuticals ApS VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 45942-1629_a2384f16-1943-49d9-93fe-f35d5c09e424 45942-1629 HUMAN OTC DRUG Refresh Sanitizing Towlette Organic Grapefruit Splash BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part333A GIOVANNI COSMETICS INC BENZALKONIUM CHLORIDE .13 1/1 N 20191231 45942-1630_be826098-6127-463b-8b16-79d64189ad55 45942-1630 HUMAN OTC DRUG Recharge Sanitizing Towlette Organic Peppermint Surge BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part333A GIOVANNI COSMETICS INC BENZALKONIUM CHLORIDE .13 1/1 N 20191231 45942-1631_e8593057-4b0b-4870-93e2-b48e4cc2c937 45942-1631 HUMAN OTC DRUG Relax Sanitizing Towlette Organic Lavender Calm BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part333A GIOVANNI COSMETICS INC BENZALKONIUM CHLORIDE .13 1/1 N 20191231 45942-1632_6ef8bf6c-c623-4c41-b1b4-7b39b379d8b8 45942-1632 HUMAN OTC DRUG Mixed Sanitizing Towlettes Grapefruit Splash, Lavender Calm, Peppermint Surge Benzalkonium Chloride KIT 20140120 OTC MONOGRAPH NOT FINAL part333A GIOVANNI COSMETICS INC N 20191231 45945-155_5b051c22-c1c9-484c-969b-1c20e07e6c05 45945-155 HUMAN PRESCRIPTION DRUG Gablofen baclofen INJECTION INTRATHECAL 20101119 20180930 NDA NDA022462 Mallinckrodt Inc (Brand Pharmaceuticals) BACLOFEN 500 ug/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 45945-156_5b051c22-c1c9-484c-969b-1c20e07e6c05 45945-156 HUMAN PRESCRIPTION DRUG Gablofen baclofen INJECTION INTRATHECAL 20120710 20190731 NDA NDA022462 Mallinckrodt Inc (Brand Pharmaceuticals) BACLOFEN 1000 ug/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 45945-157_5b051c22-c1c9-484c-969b-1c20e07e6c05 45945-157 HUMAN PRESCRIPTION DRUG Gablofen baclofen INJECTION INTRATHECAL 20101119 20200131 NDA NDA022462 Mallinckrodt Inc (Brand Pharmaceuticals) BACLOFEN 2000 ug/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 45963-125_0dc74e95-1d42-4306-bafb-5ebe874774b3 45963-125 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION ORAL 20100511 ANDA ANDA079058 Actavis Pharma, Inc. IBUPROFEN 50 mg/1.25mL N 20181231 45963-142_e5d2341c-66a6-4fdb-8dae-71e37ea0111b 45963-142 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20150217 ANDA ANDA077285 Actavis Pharma, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 45963-152_9ced3f93-d8e7-496d-bf53-fdbf78bfd307 45963-152 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20120525 ANDA ANDA077899 Actavis Pharma, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 45963-293_d59e9c75-be15-44a2-bfaa-99789be224df 45963-293 HUMAN PRESCRIPTION DRUG Trimipramine Maleate Trimipramine Maleate CAPSULE ORAL 20111121 ANDA ANDA077361 Actavis Pharma, Inc. TRIMIPRAMINE MALEATE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 45963-294_d59e9c75-be15-44a2-bfaa-99789be224df 45963-294 HUMAN PRESCRIPTION DRUG Trimipramine Maleate Trimipramine Maleate CAPSULE ORAL 20111121 ANDA ANDA077361 Actavis Pharma, Inc. TRIMIPRAMINE MALEATE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 45963-295_d59e9c75-be15-44a2-bfaa-99789be224df 45963-295 HUMAN PRESCRIPTION DRUG Trimipramine Maleate Trimipramine Maleate CAPSULE ORAL 20111021 ANDA ANDA077361 Actavis Pharma, Inc. TRIMIPRAMINE MALEATE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 45963-303_933d0b49-b121-476b-b02e-9055600ca28c 45963-303 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140619 ANDA ANDA203901 Actavis Pharma, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 45963-304_933d0b49-b121-476b-b02e-9055600ca28c 45963-304 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140619 ANDA ANDA203901 Actavis Pharma, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 45963-305_933d0b49-b121-476b-b02e-9055600ca28c 45963-305 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20140619 ANDA ANDA203901 Actavis Pharma, Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 45963-325_42354fe6-26b6-47aa-965b-190eb0f31f1c 45963-325 HUMAN PRESCRIPTION DRUG Methoxsalen Methoxsalen CAPSULE, LIQUID FILLED ORAL 20160914 ANDA ANDA202603 Actavis Pharma, Inc. METHOXSALEN 10 mg/1 Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient] N 20181231 45963-341_70d2e39b-0b5f-4f4b-9807-a024249ae0be 45963-341 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060509 ANDA ANDA074430 Actavis Pharma, Inc. DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 45963-342_70d2e39b-0b5f-4f4b-9807-a024249ae0be 45963-342 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060501 ANDA ANDA071601 Actavis Pharma, Inc. DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 45963-343_70d2e39b-0b5f-4f4b-9807-a024249ae0be 45963-343 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060604 ANDA ANDA071588 Actavis Pharma, Inc. DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 45963-344_70d2e39b-0b5f-4f4b-9807-a024249ae0be 45963-344 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060508 ANDA ANDA071602 Actavis Pharma, Inc. DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 45963-345_70d2e39b-0b5f-4f4b-9807-a024249ae0be 45963-345 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060719 ANDA ANDA071766 Actavis Pharma, Inc. DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 45963-346_70d2e39b-0b5f-4f4b-9807-a024249ae0be 45963-346 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060509 ANDA ANDA074430 Actavis Pharma, Inc. DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 45963-412_c870d8d3-2c36-469b-a9e1-2230385e075f 45963-412 HUMAN PRESCRIPTION DRUG Hydrocortisone and Acetic Acid Hydrocortisone and Acetic Acid SOLUTION AURICULAR (OTIC) 20090629 ANDA ANDA087143 Actavis Pharma, Inc. HYDROCORTISONE; ACETIC ACID 1.1; 2.41 g/100mL; g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 45963-438_c258e1e8-7b94-488d-a978-0313647ca070 45963-438 HUMAN PRESCRIPTION DRUG Enulose Lactulose SOLUTION ORAL; RECTAL 20110228 ANDA ANDA090502 Actavis Pharma, Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 45963-439_06ebdca0-18be-4da3-8ad0-0253ebe91e01 45963-439 HUMAN PRESCRIPTION DRUG Constulose Lactulose SOLUTION ORAL 20110228 ANDA ANDA090503 Actavis Pharma, Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 45963-440_d6700f48-14db-4741-9ccc-df93624ac14a 45963-440 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20150413 ANDA ANDA202472 Actavis Pharma, Inc. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 45963-460_16cb41cf-11ea-4a42-a396-a8572ccaba04 45963-460 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20121218 ANDA ANDA201921 Actavis Inc LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 45963-461_16cb41cf-11ea-4a42-a396-a8572ccaba04 45963-461 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20121218 ANDA ANDA201921 Actavis Inc LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 45963-479_617bc128-2898-557e-e053-2a91aa0aa085 45963-479 HUMAN PRESCRIPTION DRUG Alosetron Hydrochloride alosetron hydrochloride TABLET ORAL 20150526 NDA NDA021107 Actavis Pharma, Inc. ALOSETRON HYDROCHLORIDE .5 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 45963-480_617bc128-2898-557e-e053-2a91aa0aa085 45963-480 HUMAN PRESCRIPTION DRUG Alosetron Hydrochloride alosetron hydrochloride TABLET ORAL 20150526 NDA NDA021107 Actavis Pharma, Inc. ALOSETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 45963-500_8f14f3c7-8ed8-4e96-9465-3131d25dd514 45963-500 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20070328 ANDA ANDA077914 Actavis Pharma, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 45963-538_4a9c8930-383b-4d5a-a36e-88409b857d41 45963-538 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070727 ANDA ANDA077851 Actavis Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 45963-539_4a9c8930-383b-4d5a-a36e-88409b857d41 45963-539 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070727 ANDA ANDA077851 Actavis Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 45963-555_65b53348-b2bf-46e6-b96f-84139fcfde70 45963-555 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140423 ANDA ANDA075350 Actavis Pharma, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 45963-556_65b53348-b2bf-46e6-b96f-84139fcfde70 45963-556 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140403 ANDA ANDA075350 Actavis Pharma, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 45963-557_65b53348-b2bf-46e6-b96f-84139fcfde70 45963-557 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140403 ANDA ANDA075350 Actavis Pharma, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 45963-558_552ced77-c9f2-43e2-ac82-cc6c0101833e 45963-558 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20110425 ANDA ANDA090370 Actavis Pharma, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 45963-559_552ced77-c9f2-43e2-ac82-cc6c0101833e 45963-559 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20110425 ANDA ANDA090370 Actavis Pharma, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 45963-565_40e5d87c-92f4-4ca9-b95c-85290d90bdc6 45963-565 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20170426 ANDA ANDA202968 Actavis Pharma, Inc. EZETIMIBE; SIMVASTATIN 10; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 45963-566_40e5d87c-92f4-4ca9-b95c-85290d90bdc6 45963-566 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20170426 ANDA ANDA202968 Actavis Pharma, Inc. EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 45963-567_40e5d87c-92f4-4ca9-b95c-85290d90bdc6 45963-567 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20170426 ANDA ANDA202968 Actavis Pharma, Inc. EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 45963-568_40e5d87c-92f4-4ca9-b95c-85290d90bdc6 45963-568 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20170426 ANDA ANDA202968 Actavis Pharma, Inc. EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 45963-600_5d149f38-6069-4d6d-9bc1-af0ace805520 45963-600 HUMAN PRESCRIPTION DRUG FINASTERIDE FINASTERIDE TABLET, FILM COATED ORAL 20131105 ANDA ANDA078371 Actavis Pharma, Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 45963-607_b181d370-7721-41b4-b386-f0fc56f3bc04 45963-607 HUMAN PRESCRIPTION DRUG Vinorelbine Vinorelbine INJECTION, SOLUTION INTRAVENOUS 20150105 ANDA ANDA078011 Actavis Pharma, Inc. VINORELBINE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] N 20181231 45963-608_9e692465-cea8-4bec-baba-c7c26f91471e 45963-608 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION INTRAVENOUS 20111128 ANDA ANDA065445 Actavis Pharma, Inc. EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 45963-609_f2ba0440-0b0e-4f0b-bb70-8eaa7b03907b 45963-609 HUMAN PRESCRIPTION DRUG Fludarabine phosphate Fludarabine phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150105 ANDA ANDA078610 Actavis Pharma, Inc. FLUDARABINE PHOSPHATE 50 mg/2mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 45963-611_d6f87d5b-687e-4e1f-b490-ae087a80d5ae 45963-611 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150105 ANDA ANDA078803 Actavis Pharma, Inc. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 45963-612_93c4e83e-9a8b-495f-b4ce-6bb798569f26 45963-612 HUMAN PRESCRIPTION DRUG gemcitabine hydrochloride gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150202 ANDA ANDA079160 Actavis Pharma, Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 45963-613_0ec86f28-16e1-46bc-9201-b16eb98f4b47 45963-613 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20150206 ANDA ANDA090130 Actavis Pharma, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 45963-614_b5a19c3f-402a-4f38-b2a9-6c938c6e0e9b 45963-614 HUMAN PRESCRIPTION DRUG Irinotecan hydrochloride Irinotecan hydrochloride INJECTION, SOLUTION INTRAVENOUS 20150312 ANDA ANDA078589 Actavis Pharma, Inc. IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20191231 45963-615_c7d3db2a-c934-44b4-beb2-42a9bbc70827 45963-615 HUMAN PRESCRIPTION DRUG Topotecan hydrochloride Topotecan hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150105 ANDA ANDA090620 Actavis Pharma, Inc. TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 45963-619_93c4e83e-9a8b-495f-b4ce-6bb798569f26 45963-619 HUMAN PRESCRIPTION DRUG gemcitabine hydrochloride gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150202 ANDA ANDA079160 Actavis Pharma, Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 45963-620_93c4e83e-9a8b-495f-b4ce-6bb798569f26 45963-620 HUMAN PRESCRIPTION DRUG gemcitabine hydrochloride gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20161103 ANDA ANDA079160 Actavis Pharma, Inc. GEMCITABINE HYDROCHLORIDE 2 g/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 45963-621_c13b73e1-fb00-48cd-b858-f4b9896deca0 45963-621 HUMAN PRESCRIPTION DRUG Fludarabine phosphate Fludarabine phosphate INJECTION, SOLUTION INTRAVENOUS 20170302 ANDA ANDA203738 Actavis Pharma, Inc. FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 45963-623_ff2c2008-7ad9-4fcf-bc0a-968ec25c59e5 45963-623 HUMAN PRESCRIPTION DRUG Gemcitabine Gemcitabine INJECTION INTRAVENOUS 20160412 ANDA ANDA204549 Actavis Pharma, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 45963-624_ff2c2008-7ad9-4fcf-bc0a-968ec25c59e5 45963-624 HUMAN PRESCRIPTION DRUG Gemcitabine Gemcitabine INJECTION INTRAVENOUS 20160412 ANDA ANDA204549 Actavis Pharma, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 45963-633_ff08f972-823b-4390-af42-3a6cb9e6a3dd 45963-633 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 Actavis Pharma, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 45963-634_ff08f972-823b-4390-af42-3a6cb9e6a3dd 45963-634 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 Actavis Pharma, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 45963-635_ff08f972-823b-4390-af42-3a6cb9e6a3dd 45963-635 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 Actavis Pharma, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 45963-636_ff2c2008-7ad9-4fcf-bc0a-968ec25c59e5 45963-636 HUMAN PRESCRIPTION DRUG Gemcitabine Gemcitabine INJECTION INTRAVENOUS 20160412 ANDA ANDA204549 Actavis Pharma, Inc. GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 45963-640_461c6dee-1e74-406a-9548-bcc556342c3e 45963-640 HUMAN PRESCRIPTION DRUG Busulfan Busulfan INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20180104 ANDA ANDA205139 Actavis Pharma, Inc. BUSULFAN 6 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 45963-686_0ec70923-043d-4a79-91ac-ae183bf68137 45963-686 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride KIT INTRAVENOUS 20170113 ANDA ANDA206018 Actavis Pharma, Inc. N 20181231 45963-733_dc2bfb35-5a35-4984-b9dd-55d77da72abc 45963-733 HUMAN PRESCRIPTION DRUG Doxorubicin hydrochloride Doxorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20141101 ANDA ANDA203622 Actavis Pharma, Inc. DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 45963-734_0414132a-71b4-40e3-bca0-2fbec324a969 45963-734 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140901 NDA NDA203551 Actavis Pharma, Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 45963-762_b15d7780-3032-47a2-bab8-8b66db2de384 45963-762 HUMAN PRESCRIPTION DRUG levoleucovorin levoleucovorin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170214 ANDA ANDA206516 Actavis Pharma, Inc. LEVOLEUCOVORIN CALCIUM 10 mg/mL N 20181231 45963-765_3a73d2be-d3b6-4975-a776-4933b0b6480c 45963-765 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140901 NDA NDA203551 Actavis Pharma, Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 45963-781_3a73d2be-d3b6-4975-a776-4933b0b6480c 45963-781 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140901 NDA NDA203551 Actavis Pharma, Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 45963-790_3a73d2be-d3b6-4975-a776-4933b0b6480c 45963-790 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20151013 NDA NDA203551 Actavis Pharma, Inc. DOCETAXEL 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 45963-806_713c4833-e483-4962-9b68-10eccc8b8c12 45963-806 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141201 20180208 ANDA ANDA079108 Actavis Pharma, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 45963-906_a8f153bd-3c85-490c-9f5b-ebb4051e4cad 45963-906 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20170113 ANDA ANDA204686 Actavis Pharma, Inc. DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 45984-0001_7a14f2f0-e8bb-4850-91ea-2aa3f7a0b943 45984-0001 HUMAN PRESCRIPTION DRUG neobryxol Neb Argentum nitricum, Arsenicum iodatum, Bryonia, Carbo vegetabiles, Conium maculatum, Kali bichromicum, Lachesis mutus, Lycopodium, Nux vomica and Viscum album LIQUID NASAL 20120104 UNAPPROVED HOMEOPATHIC Bryomed Inc SILVER NITRATE; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CONIUM MACULATUM FLOWERING TOP; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; VISCUM ALBUM WHOLE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 45984-0002_ea6128bb-29d8-4373-b6be-e1f24a6efb13 45984-0002 HUMAN PRESCRIPTION DRUG NeobryXol Forte Asterias rubens, Bryonia, Conium maculatum, Galium aparine, Hoang-nan, Lachesis mutus, Nux vomica, Ova tosta, Sepia and Viscum album LIQUID ORAL 20120404 UNAPPROVED HOMEOPATHIC Bryomed Inc. ASTERIAS RUBENS; BRYONIA ALBA ROOT; CONIUM MACULATUM FLOWERING TOP; STRYCHNOS WALLICHIANA BARK; GALIUM APARINE; LACHESIS MUTA VENOM; STRYCHNOS NUX-VOMICA SEED; EGG SHELL, COOKED; SEPIA OFFICINALIS JUICE; VISCUM ALBUM WHOLE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 45984-0003_f4210529-a4e4-44ab-abd7-9421921e4c2c 45984-0003 HUMAN PRESCRIPTION DRUG Neobryxol Ultra Asterias rubens, Bryonia alba, Conium maculatum Galium aparine, Hoang-nan, Lachesis, Ledum palustre, Nux Vomica, Ova tosta and Viscum album. LIQUID ORAL 20120404 UNAPPROVED HOMEOPATHIC Bryomed Inc. ASTERIAS RUBENS; BRYONIA ALBA ROOT; CONIUM MACULATUM FLOWERING TOP; GALIUM APARINE; STRYCHNOS WALLICHIANA BARK; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; STRYCHNOS NUX-VOMICA SEED; EGG SHELL, COOKED; VISCUM ALBUM WHOLE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 45984-0004_beb04235-f791-4104-9ce7-ae36989337a2 45984-0004 HUMAN PRESCRIPTION DRUG Oncospray Blue Homepathic RX LIQUID ORAL 20120309 UNAPPROVED HOMEOPATHIC Bryomed Inc. ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; PHOSPHORUS; SILICON DIOXIDE; VISCUM ALBUM WHOLE; MERCURY 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL N 20181231 46006-002_761b6fe0-8816-45fb-9629-84cb49af67a6 46006-002 HUMAN OTC DRUG elave Age Delay Daily Lip Defence SPF20 Octinoxate, Zinc Oxide OINTMENT TOPICAL 20111220 OTC MONOGRAPH NOT FINAL part352 Ovelle Ltd OCTINOXATE; ZINC OXIDE 1.125; .6 mL/15mL; mL/15mL E 20171231 46007-101_105ffc42-36be-489a-bd18-b31b2194b4cf 46007-101 HUMAN OTC DRUG ACNE AND OIL CONTROL SALICYLIC ACID GEL TOPICAL 20120419 OTC MONOGRAPH FINAL part333D Skin Authority LLC SALICYLIC ACID 2 g/100mL E 20171231 46007-201_bfc27b05-aab0-4c82-a43a-382d39a973a8 46007-201 HUMAN OTC DRUG AGE DEFYING HYDRATING SUNSCREEN SPF 30 AVOBENZONE OCTINOXATE OCTISALATE OXYBENZONE HOMOSALATE OCTOCRYLENE LOTION TOPICAL 20120419 OTC MONOGRAPH FINAL part352 Skin Authority LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; HOMOSALATE; OCTOCRYLENE 3; 7.5; 5; 6; 7; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 46007-202_8181d950-e6c5-4431-a4e0-ef6c80003bb6 46007-202 HUMAN OTC DRUG AGE DEFYING MOISTURIZER SPF 18 AVOBENZONE OCTINOXATE OCTISALATE OXYBENZONE LOTION TOPICAL 20120419 OTC MONOGRAPH FINAL part352 Skin Authority LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 46007-203_0f90b87f-9aba-456f-b785-1a6b0e311f09 46007-203 HUMAN OTC DRUG SUNSCREEN MOISTURIZER SPF 30 AVOBENZONE OCTINOXATE OCTISALATE OXYBENZONE HOMOSALATE OCTOCRYLENE LOTION TOPICAL 20120419 OTC MONOGRAPH FINAL part352 Skin Authority LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; HOMOSALATE; OCTOCRYLENE 3; 7.5; 5; 6; 7; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 46007-301_d29a562a-a775-46e7-9e5a-09a087e41a40 46007-301 HUMAN OTC DRUG HYPERPIGMENTATION TREATMENT HYDROQUINONE LOTION TOPICAL 20120419 OTC MONOGRAPH FINAL part358A Skin Authority LLC HYDROQUINONE 2 g/100mL N 20181231 46011-1234_76400985-539e-4b5e-a4e6-26e6100cf15d 46011-1234 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090204 UNAPPROVED MEDICAL GAS Kadence Healthcare, Inc. OXYGEN 99 L/100L E 20171231 46014-0501_8b66b3f1-06d1-4afa-8bfc-af6c19fcd649 46014-0501 HUMAN PRESCRIPTION DRUG Hepsera Adefovir Dipivoxil TABLET ORAL 20020920 NDA NDA021449 Excella GmbH ADEFOVIR DIPIVOXIL 10 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 46014-0601_1920b87b-ac14-4b51-ae82-9ccf51f1b00e 46014-0601 HUMAN PRESCRIPTION DRUG Emtriva emtricitabine CAPSULE ORAL 20030702 NDA NDA021500 Excella GmbH EMTRICITABINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 46017-012_587358ac-e28c-11e3-8b68-0800200c9a66 46017-012 HUMAN OTC DRUG Vivarin Caffeine TABLET ORAL 20140615 OTC MONOGRAPH FINAL part340 Meda Consumer Healthcare Inc. CAFFEINE 200 mg/1 N 20181231 46017-018_d686c0c0-d232-11e3-9c1a-0800200c9a66 46017-018 HUMAN OTC DRUG Vivarin Caffeine TABLET ORAL 20120115 OTC MONOGRAPH FINAL part340 Meda Consumer Healthcare Inc. CAFFEINE 200 mg/1 N 20181231 46017-020_8ed2df71-fdb1-11e3-a3ac-0800200c9a66 46017-020 HUMAN OTC DRUG Contac Cold and Flu Day Night acetaminophen and phenylephrine hydrochloride/ acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride KIT ORAL 20140701 OTC MONOGRAPH FINAL part341 Meda Consumer Healthcare Inc. N 20181231 46017-021_758605b0-fd52-11e3-a3ac-0800200c9a66 46017-021 HUMAN OTC DRUG Contac Cold and Flu Day acetaminophen and phenylephrine hydrochloride TABLET ORAL 20140701 OTC MONOGRAPH FINAL part341 Meda Consumer Healthcare Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 46017-022_56102400-fd56-11e3-a3ac-0800200c9a66 46017-022 HUMAN OTC DRUG Contac Cold and Flu Night acetaminophen, Chlorpheniramine maleate, and phenylephrine hydrochloride TABLET ORAL 20140701 OTC MONOGRAPH FINAL part341 Meda Consumer Healthcare Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 500; 2; 5 mg/1; mg/1; mg/1 N 20181231 46017-023_4c55f3f5-c4cf-11df-851a-0800200c9a66 46017-023 HUMAN OTC DRUG Contac Cold and Flu Maximum Strength acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride TABLET ORAL 20110715 OTC MONOGRAPH FINAL part341 Meda Consumer Healthcare Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 500; 2; 5 mg/1; mg/1; mg/1 N 20181231 46017-024_d68699b0-d232-11e3-9c1a-0800200c9a66 46017-024 HUMAN OTC DRUG Contac Cold and Flu Day acetaminophen and phenylephrine hydrochloride TABLET ORAL 20110701 OTC MONOGRAPH FINAL part341 Meda Consumer Healthcare Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 46028-208_2f98ff12-1e2c-4eda-b8cb-161a11da65c6 46028-208 VACCINE Menveo Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine KIT 20100219 20180430 BLA BLA125300 Novartis Vaccines and Diagnostics s.r.l. N 20181231 46084-012_113f7b27-dc67-473f-80ed-275c08320439 46084-012 HUMAN OTC DRUG APTRIZINE 24-HOUR ALL DAY ALLERGY CETIRIZINE HYDROCHLORIDE TABLET ORAL 20130221 ANDA ANDA019835 A P J Laboratories Limited CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 46084-021_496c0fce-ed16-49f1-89fd-946140bcdedc 46084-021 HUMAN OTC DRUG APROFEN REGULAR STRENGTH IBUPROFEN TABLET ORAL 20130221 OTC MONOGRAPH FINAL part343 A P J Laboratories Limited IBUPROFEN 200 mg/1 E 20171231 46084-031_cbc1050f-9b82-4e4c-aa84-78ba062e75b0 46084-031 HUMAN OTC DRUG APTIDINE 75 RANITIDINE HYDROCHLORIDE TABLET ORAL 20130301 ANDA ANDA075132 A P J Laboratories Limited RANITIDINE HYDROCHLORIDE 75 mg/1 E 20171231 46084-041_50d6dad6-66cb-40bf-9ae0-70dd6403d46d 46084-041 HUMAN OTC DRUG APHENAP DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20130301 OTC MONOGRAPH FINAL part341 A P J Laboratories Limited DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 46084-051_b4133ea4-5e75-46d7-80b4-e7350c8ce234 46084-051 HUMAN OTC DRUG GUAAP GUAIFENESIN LIQUID ORAL 20130301 OTC MONOGRAPH FINAL part341 A P J Laboratories Limited GUAIFENESIN 100 mg/5mL E 20171231 46084-061_5d9790ab-2120-4b04-a87c-d27e1e0640a2 46084-061 HUMAN OTC DRUG APINOPHEN EXTRA STRENGTH ACETAMINOPHEN TABLET ORAL 20130301 OTC MONOGRAPH NOT FINAL part343 A P J Laboratories Limited ACETAMINOPHEN 500 mg/1 E 20171231 46084-071_8747131c-4c0b-4306-8bd9-b29cefb71296 46084-071 HUMAN OTC DRUG APCAL Calcium Carbonate and Vitamin D3 TABLET ORAL 20130301 OTC MONOGRAPH FINAL part331 A P J Laboratories limited CALCIUM CARBONATE; CHOLECALCIFEROL 1250; 250 mg/1; [iU]/1 E 20171231 46084-081_8ef19bfe-6e70-4aed-979b-274315278c63 46084-081 HUMAN OTC DRUG APTRIMAZOLE 1.0% ANTIFUNGAL CREAM CLOTRIMAZOLE CREAM TOPICAL 20130427 OTC MONOGRAPH FINAL part333C A P J Laboratories Limited CLOTRIMAZOLE 1 g/100g E 20171231 46084-091_14d51b10-696d-4626-bb3b-143cde538b2f 46084-091 HUMAN OTC DRUG IBUPROFEN COLD AND SINUS A P J IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED ORAL 20130601 ANDA ANDA074567 A P J Laboratories Limited IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 E 20171231 46084-101_529b0e8e-4f74-4d96-b9dc-c57ba66162d3 46084-101 HUMAN OTC DRUG ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20130606 OTC MONOGRAPH FINAL part341 A P J Laboratories Limited ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 E 20171231 46084-111_a0c485a4-d719-42e7-8764-459756dfdae3 46084-111 HUMAN OTC DRUG APJ HEMORRHOIDAL PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM OINTMENT TOPICAL 20130701 OTC MONOGRAPH FINAL part346 A P J Laboratories Limited PHENYLEPHRINE HYDROCHLORIDE; PETROLATUM; MINERAL OIL 2.55; 720; 140 mg/g; mg/g; mg/g E 20171231 46084-121_c75e18ea-fbbe-477e-a961-6ce6d1954cab 46084-121 HUMAN OTC DRUG DAYTIME NIGHTTIME COLD/FLU RELIEF A P J DAYTIME NIGHTTIME COLD/FLU RELIEF KIT 20130601 OTC MONOGRAPH FINAL part341 A P J Laboratories Limited E 20171231 46088-010_f74dc486-5967-427c-aa71-166f11574950 46088-010 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20080101 UNAPPROVED MEDICAL GAS Purepoint, Inc OXYGEN 99 L/100L N 20181231 46122-010_46bb0d99-489d-49bb-bdc6-4cf668e8ac61 46122-010 HUMAN OTC DRUG Good Neighbor Pharmacy Ibuprofen Ibuprofen TABLET ORAL 20091019 ANDA ANDA076359 Amerisource Bergen IBUPROFEN 100 mg/1 N 20181231 46122-013_95e3b870-6f78-4ace-83de-da19b6d7c087 46122-013 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY DIAPER RASH CREAMY ZINC OXIDE OINTMENT TOPICAL 20120501 OTC MONOGRAPH FINAL part347 AMERISOURCE BERGEN ZINC OXIDE .1 g/g E 20171231 46122-014_d16945ca-59e2-4c66-b61f-f3da740d6811 46122-014 HUMAN OTC DRUG Good Neighbor Pharmacy ClearLax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091019 ANDA ANDA090685 Amerisource Bergen POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 46122-015_c250e344-4d58-4b0f-a07e-6320d8241edc 46122-015 HUMAN OTC DRUG Flu Relief Therapy Daytime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20130430 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 46122-016_ad68acb5-060d-4bb9-a61e-c8f71c276683 46122-016 HUMAN OTC DRUG Flu Relief Therapy Nighttime Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20130430 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 46122-017_886331f4-afb4-483b-8edf-9e4c392d6fda 46122-017 HUMAN OTC DRUG Good Neighbor Pharmacy tussin dm max adult Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20100907 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 46122-018_e0aee839-06bb-4398-aa39-eb623dbfca37 46122-018 HUMAN OTC DRUG GNP Lubricant Eye Polyethylene Glycol 400 SOLUTION/ DROPS OPHTHALMIC 20130630 OTC MONOGRAPH FINAL part349 Amerisource Bergen POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mg/mg; mg/mg N 20181231 46122-020_4cfaefc4-4d95-4792-a3b4-0bfb4169ca9c 46122-020 HUMAN OTC DRUG Good Neighbor Pharmacy Allergy childrens all day cetirizine Hydrochloride SOLUTION ORAL 20101029 ANDA ANDA090254 Amerisource Bergen CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 46122-022_6714df62-0cde-4302-b549-b6dcfa4d14d8 46122-022 HUMAN OTC DRUG good neighbor pharmacy flu and severe cold and cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20110204 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 46122-029_5ee545f5-e5f2-4fad-9bf8-9454c3f934ef 46122-029 HUMAN OTC DRUG good neighbor pharmacy omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080227 NDA NDA022032 Amerisource Bergen OMEPRAZOLE 20 mg/1 N 20181231 46122-030_d25d611e-ad01-4212-8f47-ec07cbcc43d0 46122-030 HUMAN OTC DRUG Good Neighbor Pain Relief Benzocaine LIQUID ORAL 20080801 OTC MONOGRAPH NOT FINAL part356 AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) BENZOCAINE 200 mg/mL N 20181231 46122-034_967a3a31-68de-42c0-8b7a-1a7826fa2274 46122-034 HUMAN OTC DRUG Nighttime Cold Multi-Symptom Cool Blast Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl LIQUID ORAL 20110304 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 46122-038_09ed037b-38f2-4316-821c-17b835294261 46122-038 HUMAN OTC DRUG Good Neighbor Pharmacy Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20110106 NDA NDA021920 Amerisource Bergen NAPROXEN SODIUM 220 mg/1 N 20181231 46122-039_8c23271d-d1dc-40e1-a99c-f0cb9ba63c0e 46122-039 HUMAN OTC DRUG Miconazole Nitrate Miconazorb AF Antifungal Powder POWDER TOPICAL 20120110 OTC MONOGRAPH FINAL part333C AmerisourceBergen Drug Corporation MICONAZOLE NITRATE 1.42 g/71g N 20181231 46122-040_d3d8b4d4-f854-4ac9-b250-748320a1c681 46122-040 HUMAN OTC DRUG good neighbor pharmacy allergy relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110622 ANDA ANDA076447 Amerisource Bergen FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 46122-041_ca051de0-704c-4dbd-8b9a-62cb15fd391d 46122-041 HUMAN OTC DRUG good neighbor pharmacy acid control 150 Ranitidine TABLET, FILM COATED ORAL 20111004 ANDA ANDA091429 Amerisource Bergen RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 46122-042_4874ac40-ef8c-460d-885d-2483d383c4d8 46122-042 HUMAN OTC DRUG good neighbor pharmacy pain and fever Acetaminophen SUSPENSION ORAL 20110828 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL N 20181231 46122-043_1e91a32c-524e-44ab-9553-b3e761dc3944 46122-043 HUMAN OTC DRUG Good Neighbor Pharmacy Alcohol Antiseptic Skin Cleanser Isopropyl Alcohol SWAB TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A Amerisouce Bergen ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 46122-044_f0abc596-7093-4a63-b3e5-d507c7085ba1 46122-044 HUMAN OTC DRUG GNP Acne Treatment Benzoyl Peroxide CREAM TOPICAL 20130630 OTC MONOGRAPH FINAL part333D Amerisource Bergen BENZOYL PEROXIDE 10 g/100g E 20171231 46122-050_56b18441-1704-49d1-9263-0b8e7f1a4a76 46122-050 HUMAN OTC DRUG Childrens Acetaminophen Cherry Childrens Tylenol SUSPENSION ORAL 20120101 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN 160 mg/5mL N 20181231 46122-051_ba016b9f-9275-439a-b722-3162229016c6 46122-051 HUMAN OTC DRUG Infant Gas Relief Dye Free Simethicone SUSPENSION ORAL 20140630 OTC MONOGRAPH FINAL part332 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DIMETHICONE 20 mg/.3mL N 20181231 46122-052_2b9443fd-881f-2352-e054-00144ff8d46c 46122-052 HUMAN OTC DRUG Allergy Plus Sinus Headache Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20110629 OTC MONOGRAPH FINAL part341 AmeriSource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 46122-053_2b94a2ae-b88c-60e7-e054-00144ff88e88 46122-053 HUMAN OTC DRUG Allergy Plus Severe Sinus Headache ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110629 OTC MONOGRAPH FINAL part341 AmeriSource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 46122-054_6a40bc88-e271-484b-a860-3b52471da070 46122-054 HUMAN OTC DRUG GNP Hygienic Cleansing Pads Witch Hazel SOLUTION RECTAL; TOPICAL 20130630 OTC MONOGRAPH FINAL part346 Amerisource Bergen WITCH HAZEL .5 mg/mg N 20181231 46122-055_1b91f562-e8d2-42e9-9bea-ea24ec7234bf 46122-055 HUMAN OTC DRUG GNP Medicated Wipes Witch Hazel SOLUTION RECTAL; TOPICAL 20130630 OTC MONOGRAPH FINAL part346 Amerisource Bergen WITCH HAZEL .5 mg/mg N 20181231 46122-056_ced2d30c-c637-4017-86e5-d1a463040543 46122-056 HUMAN OTC DRUG good neighbor pharmacy Pain and Fever Acetaminophen SUSPENSION ORAL 20110828 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL N 20181231 46122-057_916c59ed-07ea-4e0b-a6c0-de357d78ee0e 46122-057 HUMAN OTC DRUG Good Neighbor Pharmacy TabTussin Guaifenesin TABLET ORAL 20110926 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corp GUAIFENESIN 400 mg/1 N 20181231 46122-058_3f97cc9d-4bdf-4862-8bcd-ff2f0ef62d2b 46122-058 HUMAN OTC DRUG Good Neighbor Pharmacy Tab Tussin DM DMTDM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 AmerisourceBergen Drug Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 46122-059_863a0489-17e1-4c6f-925e-5142cb6a0b75 46122-059 HUMAN OTC DRUG Isopropyl Alcohol 70 Percent Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20141231 OTC MONOGRAPH NOT FINAL part333A AmerisourceBergen (Good Neighbor Pharmacy) 46122 ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 46122-060_7c620eb5-997a-4e6f-8745-cd745981b1aa 46122-060 HUMAN OTC DRUG Isopropyl Alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141231 OTC MONOGRAPH NOT FINAL part333A AmerisourceBergen (Good Neighbor Pharmacy) 46122 ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 46122-062_4fef2c61-8322-49ae-8bec-521fe9eb696b 46122-062 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Amerisource Bergen ACETAMINOPHEN 650 mg/1 N 20181231 46122-071_459fcbbf-c570-4a41-88f2-9985383df4ae 46122-071 HUMAN OTC DRUG Ethyl Alcohol 70 percent Ethyl alcohol LIQUID TOPICAL 20141231 OTC MONOGRAPH NOT FINAL part333A AmerisourceBergen (Good Neighbor Pharmacy) 46122 ALCOHOL 70 mL/100mL N 20181231 46122-072_2b9443fd-8833-2352-e054-00144ff8d46c 46122-072 HUMAN OTC DRUG Cold Relief Multi-Symptom Severe ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20111017 OTC MONOGRAPH FINAL part341 AmeriSource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 46122-073_2b94a2ae-b8a0-60e7-e054-00144ff88e88 46122-073 HUMAN OTC DRUG Cold Relief Multi-Symptom Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20111017 OTC MONOGRAPH FINAL part341 AmeriSource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 46122-074_2b94b275-756b-34c2-e054-00144ff8d46c 46122-074 HUMAN OTC DRUG Sinus Relief Congestion and Pain Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20111028 OTC MONOGRAPH FINAL part341 AmeriSource Bergen ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 46122-075_2b94a2ae-b8b5-60e7-e054-00144ff88e88 46122-075 HUMAN OTC DRUG Sinus Relief Congestion and Pain - Daytime and Nighttime Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride KIT 20111028 OTC MONOGRAPH FINAL part341 AmeriSource Bergen N 20181231 46122-100_8ed45954-251e-4ccf-ac0a-2695484faf6d 46122-100 HUMAN OTC DRUG Good Neighbor Pharmacy Natural Fiber Psyllium husk CAPSULE ORAL 20100712 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug Corporation PSYLLIUM HUSK .52 g/1 N 20181231 46122-101_b1ebbc59-6846-4cf1-b4a7-3429ee26652c 46122-101 HUMAN OTC DRUG All Day Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Amerisource Bergen CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 46122-103_2c792091-bfff-4751-b294-480a047971c3 46122-103 HUMAN OTC DRUG Good Neighbor Pharmacy Hemorrhoidal Mineral Oil OINTMENT TOPICAL 20130630 OTC MONOGRAPH FINAL part346 Amerisource Bergen MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 74.9; 2.5 mg/100g; mg/100g; mg/100g N 20181231 46122-104_e1f67e3f-d08e-4ec8-8b73-fb659154571d 46122-104 HUMAN OTC DRUG Headache relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET ORAL 20120415 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 46122-107_d43e247f-e50b-41c5-8437-5df8c904eb4b 46122-107 HUMAN OTC DRUG Good Neighbor Pharmacy Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120531 ANDA ANDA202319 Amerisource Bergen LANSOPRAZOLE 15 mg/1 N 20181231 46122-108_654ef9d6-0a29-4168-877b-542f2a8a382a 46122-108 HUMAN OTC DRUG good neighbor pharmacy lice treatment Permethrin LOTION TOPICAL 20120307 ANDA ANDA076090 Amerisource Bergen PERMETHRIN 1 mg/100mL N 20181231 46122-109_ab2d358a-809c-435d-93ce-f36b55aa7880 46122-109 HUMAN OTC DRUG good neighbor pharmacy loratadine d Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120323 ANDA ANDA076050 Amerisource Bergen LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 46122-110_ed37bf7a-96bc-4b2b-82b0-ab44ee403888 46122-110 HUMAN OTC DRUG good neighbor pharmacy childrens ibuprofen Ibuprofen SUSPENSION ORAL 20020402 ANDA ANDA074937 Amerisource Bergen IBUPROFEN 100 mg/5mL N 20181231 46122-111_541d7244-43ad-4624-b468-a7fb53604c38 46122-111 HUMAN OTC DRUG good neighbor pharmacy Loperamide hydrochloride loperamide HCl LIQUID ORAL 20120217 ANDA ANDA091292 Amerisource Bergen LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 46122-112_cf626574-6a68-4fcd-9986-c036cbec8cf1 46122-112 HUMAN OTC DRUG Good Neighbor Pharmacy Capsaicin Capsaicin LIQUID TOPICAL 20111028 OTC MONOGRAPH NOT FINAL part348 Amerisourcebergen Drug Corporation CAPSAICIN 150 mg/100000mg N 20181231 46122-113_40c7438e-d105-4c61-a56d-7f6064c7fcdd 46122-113 HUMAN OTC DRUG Good Neighbor Pharmacy Burn Relief Aloe Extra Lidocaine SPRAY CUTANEOUS 20111028 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen Drug Corporation LIDOCAINE .5 g/100g N 20181231 46122-114_ad9688ce-79d1-44ec-aeaf-a7c9e6c7f2fe 46122-114 HUMAN OTC DRUG Good Neighbor Pharmacy Itch Relief Extra Strength Diphenhydramine, Zinc Acetate AEROSOL, SPRAY TOPICAL 20111028 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen Drug Corporation DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 46122-115_13117be6-3ec4-499e-a36b-b361a9f34cde 46122-115 HUMAN OTC DRUG Good Neighbor Pharmacy First Aid Benzocaine, Triclosan AEROSOL, SPRAY TOPICAL 20111028 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen Drug Corporation BENZOCAINE; TRICLOSAN 20; 130 g/100g; mg/100g N 20181231 46122-116_4d92cdaa-838a-4032-a837-0843bf035481 46122-116 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY CAPSAICIN CAPSAICIN CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part348 AMERISOURCE BERGEN CAPSAICIN .1 g/100g E 20171231 46122-118_eea23fff-43b5-484e-967c-0f38f2cc737b 46122-118 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY ZINC OXIDE ZINC OXIDE OINTMENT TOPICAL 20120401 OTC MONOGRAPH FINAL part347 AMERISOURCE BERGEN ZINC OXIDE 20 g/100g N 20181231 46122-126_2b94b275-757f-34c2-e054-00144ff8d46c 46122-126 HUMAN OTC DRUG Cold Relief Head Congestion Severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20120319 OTC MONOGRAPH FINAL part341 AmeriSource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 46122-134_16e3e61c-2123-4e41-970a-202ae8c2472c 46122-134 HUMAN OTC DRUG good neighbor pharmacy headache pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20000201 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 46122-136_8bf59934-4c22-4fbc-a3f4-8d04c49ea2df 46122-136 HUMAN OTC DRUG good neighbor pharmacy night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110828 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 46122-137_26f3f68f-df27-13f7-e054-00144ff8d46c 46122-137 HUMAN OTC DRUG Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% LIQUID TOPICAL 20130401 NDA NDA019125 AmerisourceBergen Drug Corporation CHLORHEXIDINE GLUCONATE 4 mg/100mL N 20181231 46122-138_c5bcfdec-8eb0-4188-a75a-acab99f9a00f 46122-138 HUMAN OTC DRUG good neighbor pharmacy tussin cf max dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20120802 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 46122-139_f47cfecf-3955-494f-bc9c-2136a149bbb9 46122-139 HUMAN OTC DRUG good neighbor pharmacy tussin dm max dextromethorphan hbr, guaifenesin SUSPENSION ORAL 20120802 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 46122-140_fd7412ea-a337-49d7-b25e-012e193111b5 46122-140 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Good Neighbor Pharmacy LORATADINE 10 mg/1 N 20181231 46122-141_e5879277-23dc-4ca4-b218-14a21205e0a9 46122-141 HUMAN OTC DRUG Good Neighbor Pharmacy Cough DM ER dextromethorphan polistirex SUSPENSION ORAL 20120830 ANDA ANDA091135 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 46122-142_86407a02-70b0-4df9-9fe2-ab49584c08bb 46122-142 HUMAN OTC DRUG Good Neighbor Pharmacy Cough DM ER dextromethorphan polistirex SUSPENSION ORAL 20130624 ANDA ANDA091135 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 46122-143_c161ba96-1a89-48af-baf9-da75f916602e 46122-143 HUMAN OTC DRUG Good Neighbor Pharmacy Anti-Itch Steroid Free Camphor, Menthol LOTION CUTANEOUS 20130128 OTC MONOGRAPH NOT FINAL part348 AmerisourceBergen Drug Corporation CAMPHOR (NATURAL); MENTHOL .5; .5 g/100mL; g/100mL N 20181231 46122-145_3907bb55-3c39-48b7-b905-ab2e8da34b5e 46122-145 HUMAN OTC DRUG good neighbor pharmacy ibuprofen pm Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20120802 ANDA ANDA079113 Amerisource Bergen DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 46122-146_cd202a72-4588-4a96-a02d-9daedcbd3a24 46122-146 HUMAN OTC DRUG Itchy Eye Drops ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC 20131206 ANDA ANDA077958 Amerisource Bergen KETOTIFEN FUMARATE .35 mg/mL N 20181231 46122-149_dfc0e0b9-44d3-4b44-8062-098e4f5e18e1 46122-149 HUMAN OTC DRUG Good Neighbor Pharmacy Fast Acting Nasal Phenylephrine hydrochloride SPRAY NASAL 20150820 OTC MONOGRAPH FINAL part341 Amerisource Bergen PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL N 20181231 46122-150_a3a0d776-5fe3-4b6d-bb00-cc92e683ef3e 46122-150 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY Antacid Extra Strength aluminum hydroxide and magnesium carbonate TABLET, CHEWABLE ORAL 20150812 OTC MONOGRAPH FINAL part331 Amerisource Bergen ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 N 20181231 46122-151_4c7c7618-45b5-4678-b6ac-0f322a985bb7 46122-151 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid and Anti Gas Maximum Strength Antacid and Antigas TABLET, CHEWABLE ORAL 20150825 OTC MONOGRAPH FINAL part332 Amerisource Bergen CALCIUM CARBONATE; DIMETHICONE 1000; 60 mg/1; mg/1 N 20181231 46122-153_f2e137c0-e572-42e3-bb4c-d9998187dcdd 46122-153 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY Antacid Regular Strength Calcium carbonate and Magnesium hydroxide TABLET, CHEWABLE ORAL 20150825 OTC MONOGRAPH FINAL part331 Amerisource Bergen CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 550; 110 mg/1; mg/1 N 20181231 46122-157_1960fb28-b4bf-4e2e-a2b1-c2cdaf8ac753 46122-157 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090908 OTC MONOGRAPH FINAL part341 AmersourceBergen CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg N 20181231 46122-158_edba298d-ed0a-4f7e-a1b0-0afff57a1edd 46122-158 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Amerisource Bergen LORATADINE 10 mg/1 N 20181231 46122-161_f6a6bc0c-1164-4f52-9fb3-165e4e6a417a 46122-161 HUMAN OTC DRUG Good Neighbor Pharmacy Sodium Phosphate Enema ENEMA RECTAL 20130301 OTC MONOGRAPH NOT FINAL part334 AMERISOURCEBERGEN DRUG CORPORATION SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 46122-162_6e476b3b-2aed-490b-b6ba-7c129c48e3eb 46122-162 HUMAN OTC DRUG Good Neighbor Mineral Oil Mineral Oil ENEMA RECTAL 20130301 OTC MONOGRAPH NOT FINAL part334 AMERISOURCEBERGEN DRUG CORPORATION MINERAL OIL 118 mL/118mL E 20171231 46122-163_e735287e-92a2-4037-8650-e763c6895af9 46122-163 HUMAN OTC DRUG Eye Itch Relief ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC 20131206 ANDA ANDA077958 Amerisource Bergen KETOTIFEN FUMARATE .35 mg/mL N 20181231 46122-164_8ff17952-4a96-4093-8cca-fee6f443904c 46122-164 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 AmerisourceBergen LORATADINE 5 mg/5mL N 20181231 46122-165_9c3d7281-59f4-4618-b303-4fc3a3f88f4b 46122-165 HUMAN OTC DRUG good neighbor pharmacy nasal oxymetazoline hydrochloride SPRAY NASAL 19900115 OTC MONOGRAPH FINAL part341 Amerisource Bergen OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 46122-166_a8c0d9b9-de99-4e30-bd0f-18488585dc60 46122-166 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Amerisource Bergen PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 46122-167_75855860-b79d-41e4-80df-be40864823b5 46122-167 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Amerisource Bergen LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 46122-168_32b78301-99ce-4b9c-9e74-461be74005df 46122-168 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20130501 ANDA ANDA090283 AMERISOURCE BERGEN FAMOTIDINE 20 mg/1 N 20181231 46122-169_80a4c80a-d34f-48d8-8484-f605ad892a25 46122-169 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Amerisource Bergen LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 46122-170_880665b0-58d2-4d20-b3ad-d0bd2ceacf0f 46122-170 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Amerisource Bergen ACETAMINOPHEN 650 mg/1 N 20181231 46122-171_4e1d7262-d7a1-44cc-80b9-62e35478576e 46122-171 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20140123 ANDA ANDA078325 Amerisource Bergen NICOTINE 2 mg/1 N 20181231 46122-172_78ed88ba-afbe-444e-9458-ce47eb312b7e 46122-172 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20140123 ANDA ANDA078326 Amerisource Bergen NICOTINE 4 mg/1 N 20181231 46122-173_e1f33fce-5c18-4e99-9bf3-69dcc27be763 46122-173 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20130722 ANDA ANDA076775 Amerisource Bergen NICOTINE 2 mg/1 N 20181231 46122-174_de88c471-b7b3-425b-bea7-813da3cb7c7c 46122-174 HUMAN OTC DRUG good neighbor pharmacy nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050831 ANDA ANDA076789 Amerisource Bergen NICOTINE 4 mg/1 N 20181231 46122-176_106f58f3-ea8f-4eb4-bb15-f7d0e9e37cf1 46122-176 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex LOZENGE ORAL 20130802 ANDA ANDA077007 Amerisource Bergen NICOTINE 2 mg/1 N 20181231 46122-177_90f161fc-8be5-4d04-a5c2-b6fa92b29a22 46122-177 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex LOZENGE ORAL 20140319 ANDA ANDA077007 Amerisource Bergen NICOTINE 4 mg/1 N 20181231 46122-179_86fa81c8-3fd5-4bd0-99b8-d6b2ec7dc88b 46122-179 HUMAN OTC DRUG Pain Relief PM Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130423 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 46122-180_028c9ccb-6eba-48a2-afcb-09b37d2e8bfb 46122-180 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ASPIRIN 81 mg/1 N 20181231 46122-181_bbcde376-c820-4a63-821e-09a71777e757 46122-181 HUMAN OTC DRUG Cold and Allergy Maximum Strength Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20110402 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 46122-182_2faa31c0-ddf3-458d-8625-28dfe39dfcaf 46122-182 HUMAN OTC DRUG Aspirin Adult Low Strength Aspirin Aspirin TABLET, COATED ORAL 20110317 20180630 OTC MONOGRAPH FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ASPIRIN 81 mg/1 N 20181231 46122-183_47eb60d9-7647-4cbe-bd5a-efc86474790e 46122-183 HUMAN OTC DRUG Night time cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130225 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 46122-184_5818e817-f2a5-4acd-baa2-98efd15fb558 46122-184 HUMAN OTC DRUG Day time cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130210 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 46122-185_72fd3fd4-7cb2-4057-8ea3-e5dfb1b40bf5 46122-185 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY Hydrogen Peroxide Wipes HYDROGEN PEROXIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen HYDROGEN PEROXIDE 3 g/100g N 20181231 46122-188_4848f613-6985-40df-9674-13cd889424b7 46122-188 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY Isopropyl Alcohol Wipes ISOPROPYL ALCOHOL LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen ISOPROPYL ALCOHOL 70 g/100g N 20181231 46122-192_fe198ed9-3754-4309-8f13-5524295a05c9 46122-192 HUMAN OTC DRUG Good neighbor pharmacy mucus relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130624 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 46122-194_07715399-4f6c-4942-a590-c752ebb9dd8f 46122-194 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus Relief cold and sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130802 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 46122-195_7751c2f3-171e-4bea-bad9-bdc8cc30533a 46122-195 HUMAN OTC DRUG good neighbor pharmacy lubricating plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130517 OTC MONOGRAPH FINAL part349 Amerisource Bergen CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM .5 g/100mL N 20181231 46122-196_d2a3c212-8b2c-4c29-92c6-97421b84386b 46122-196 HUMAN OTC DRUG good neighbor pharmacy congestion relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20140927 ANDA ANDA203200 Amerisource Bergen IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20181231 46122-197_faa60bbf-5c20-48ca-8f87-c44f15f71676 46122-197 HUMAN OTC DRUG Good Neighbor Pharmacy Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130822 ANDA ANDA076518 Amerisource Bergen NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 46122-198_3d66c378-a2f9-423d-b0bb-ee152ef59007 46122-198 HUMAN OTC DRUG good neighbor pharmacy night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20111016 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 46122-199_dc31df89-f45d-411f-9740-c586e5fa6211 46122-199 HUMAN OTC DRUG PEG-Phen Lubricant Eye Drops Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20130322 OTC MONOGRAPH FINAL part349 Amerisource Bergen POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 46122-200_393a4319-d7b8-4181-8ea9-5b8f2d4a6a43 46122-200 HUMAN OTC DRUG CMC Lubricant Eye Drops Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20130322 OTC MONOGRAPH FINAL part349 Amerisource Bergen CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 46122-201_4a345b8d-7853-42d9-bbd4-42b6a9c6e54e 46122-201 HUMAN OTC DRUG PEG-Phen Ultra Lubricant Eye Drops Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20130322 OTC MONOGRAPH FINAL part349 Amerisource Bergen POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 46122-202_f506194d-c79f-4001-a651-e21a3f51b9db 46122-202 HUMAN OTC DRUG Lubricant PM Mineral Oil, White Petrolatum OINTMENT OPHTHALMIC 20130501 OTC MONOGRAPH FINAL part349 Amerisource Bergen MINERAL OIL; PETROLATUM 425; 573 mg/g; mg/g N 20181231 46122-203_c6951587-fe03-4bc8-8f0c-0687d49f7159 46122-203 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens All Day Allergy Cetirizine HCl SOLUTION ORAL 20151110 ANDA ANDA204226 Amerisource Bergen CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 46122-204_d8e5602e-318f-4d7e-bdc1-2e1926b4cd95 46122-204 HUMAN OTC DRUG Good Neighbor Pharmacy Sleep Time Diphenhydramine HCl SOLUTION ORAL 20130722 OTC MONOGRAPH FINAL part338 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 46122-205_c70dca82-e80d-43a4-93fc-45fc65638c6b 46122-205 HUMAN OTC DRUG Good Neighbor Pharmacy acid reducer Famotidine TABLET ORAL 20091007 ANDA ANDA075400 Amerisource Bergen FAMOTIDINE 10 mg/1 N 20181231 46122-207_fa02b9a4-4ffa-491f-99d4-c1389ef1b66a 46122-207 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl CAPSULE, LIQUID FILLED ORAL 20130607 NDA NDA021855 AmerisourceBergen (Good Neighbor Pharmacy) 46122 LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 46122-208_d0ceaced-316e-4f38-8bc8-07adcffd5dc8 46122-208 HUMAN OTC DRUG Good Neighbor Pharmacy Sleep Time Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140130 OTC MONOGRAPH FINAL part338 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 46122-210_ae63bcf8-4654-437f-9818-c10a08fe6c2c 46122-210 HUMAN OTC DRUG good neighbor pharmacy childrens pain and fever Acetaminophen SUSPENSION ORAL 19931012 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL N 20181231 46122-212_bb190952-d872-48ad-93c5-275d0e5560ee 46122-212 HUMAN OTC DRUG good neighbor pharmacy childrens pain and fever Acetaminophen SUSPENSION ORAL 20110201 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL N 20181231 46122-217_d915a60b-8835-4b16-aa3f-1e7c0131d8d1 46122-217 HUMAN OTC DRUG Mucus Relief Cold, Flu and Sore Throat Maximum Strength Mucinex Cold, Flu and Sore Throat Maximum Strength LIQUID ORAL 20131104 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 400; 20; 650; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 46122-218_665ff078-13da-4353-b00b-bdb3b1089a65 46122-218 HUMAN OTC DRUG Mucus Relief DM Max Maximum Strength Mucinex DM Max Maximum Strength LIQUID ORAL 20131025 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/20mL; mg/20mL N 20181231 46122-219_e4565f15-7bf1-48f3-bf5f-bb134e68c99c 46122-219 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Mucinex Congestion and Cough Maximum Strength LIQUID ORAL 20131104 OTC MONOGRAPH FINAL part341 Good Neighbor Pharmacy GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 400; 20; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 46122-223_ace6f559-73e4-4853-a71f-5d3b7cb96031 46122-223 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130906 ANDA ANDA201745 Amerisource Bergen RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 46122-224_8bbdce69-ba74-49f1-b72e-05b382a18778 46122-224 HUMAN OTC DRUG Good Neighbor Pharmacy Acid Control 150 Ranitidine TABLET, FILM COATED ORAL 20120208 ANDA ANDA091429 Amerisource Bergen RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 46122-229_2b94a2ae-b878-60e7-e054-00144ff88e88 46122-229 HUMAN OTC DRUG Sinus Relief Congestion and Pain Severe ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130926 OTC MONOGRAPH FINAL part341 AmeriSource Bergen ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 46122-230_2b94b275-7594-34c2-e054-00144ff8d46c 46122-230 HUMAN OTC DRUG Cold Relief Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130926 OTC MONOGRAPH FINAL part341 AmeriSource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 46122-231_35c8ce2d-2fc9-4845-b597-a46f011925ff 46122-231 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DOCUSATE SODIUM 100 mg/1 N 20181231 46122-232_0f986178-29e6-4f29-8c1a-62cc10f23c90 46122-232 HUMAN OTC DRUG Good Neighbor Pharmacy Severe Day Time acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140123 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 46122-233_6a690fb3-ccb1-433e-8005-e96c4c2547ec 46122-233 HUMAN OTC DRUG Good Neighbor Pharmacy Night Time Severe Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140109 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 46122-234_ea2ca472-9b3e-46dc-9449-cc87bdd68807 46122-234 HUMAN OTC DRUG Good Neighbor Pharmacy Day Time Severe acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20140109 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 46122-235_0b7cc4bc-897f-441b-a8b6-3b8303457bde 46122-235 HUMAN OTC DRUG good neighbor pharmacy childrens mucus relief dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20140218 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 46122-239_5e2a4027-8338-4249-8261-2d4504504de7 46122-239 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus D Guaifenesin, pseudoephedrine hydrochloride TABLET ORAL 20151221 ANDA ANDA091071 Amerisource Bergen GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 46122-241_2e7a424d-6626-4772-bb47-bd5d3dd181b3 46122-241 HUMAN OTC DRUG Good Neighbor Pharmacy Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140131 ANDA ANDA091292 Amerisource Bergen LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 46122-244_3d1694ea-3f3e-45d5-8edf-8b31ac7d3a40 46122-244 HUMAN OTC DRUG Good Neighbor Pharmacy Antibiotic and Pain Relief Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20140211 OTC MONOGRAPH FINAL part333B Amerisource Bergen NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g N 20181231 46122-245_622a6e93-aba8-4fb6-8977-330e073749c0 46122-245 HUMAN OTC DRUG Good Neighbor Pharmacy Night Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140306 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 46122-247_2b94a2ae-b865-60e7-e054-00144ff88e88 46122-247 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen TABLET ORAL 20110629 OTC MONOGRAPH NOT FINAL part343 AmeriSource Bergen ACETAMINOPHEN 325 mg/1 N 20181231 46122-248_d7c7148b-49f7-41da-b0da-bec72c8b478b 46122-248 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140131 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 46122-254_9cd187e1-1b9e-44f9-8e0b-4efeff78fcb4 46122-254 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex LOZENGE ORAL 20140814 ANDA ANDA203690 Amerisource Bergen NICOTINE 2 mg/1 N 20181231 46122-255_6b695002-f6d6-4d33-a386-e7b3adc83369 46122-255 HUMAN OTC DRUG good neighbor pharmacy nicotine mini Nicotine Polacrilex LOZENGE ORAL 20140907 ANDA ANDA203690 Amerisource Bergen NICOTINE 4 mg/1 N 20181231 46122-256_f8a84568-cd98-4561-ad9c-b5eb4f8ddfc7 46122-256 HUMAN OTC DRUG Laxative pills maximum strength Sennosides TABLET ORAL 20140731 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 SENNOSIDES 25 mg/1 N 20181231 46122-257_07f57d8e-e9dc-4aa7-b7de-65f2b2567f78 46122-257 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN 500 mg/1 N 20181231 46122-260_a042c2d1-7632-4632-a9d1-6e7b8dee7151 46122-260 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20140630 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DOCUSATE CALCIUM 240 mg/1 N 20181231 46122-262_19553cca-7394-4436-8037-d82fe335773d 46122-262 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ASPIRIN 81 mg/1 N 20181231 46122-263_4da6bbf6-e488-4602-918f-b9c05274e782 46122-263 HUMAN OTC DRUG Stool Softener Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DOCUSATE SODIUM 250 mg/1 N 20181231 46122-265_5b9b03a9-d095-498f-9484-605ede559ac6 46122-265 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140731 OTC MONOGRAPH NOT FINAL part356 AmerisourceBergen (Good Neighbor Pharmacy) 46122 PHENOL 1.4 g/100mL N 20181231 46122-266_324cc1d7-e222-4da7-b19d-b103109f0c48 46122-266 HUMAN OTC DRUG Good Neighbor Pharmacy Allergy Relief Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20140815 ANDA ANDA076447 Amerisource Bergen FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 46122-267_2b04144a-a2f1-4e1d-bed5-d4fee0166ccd 46122-267 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus Relief Severe Cold Cold and Flu Night Time Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl, diphenhydramine HCl KIT 20150218 OTC MONOGRAPH FINAL part341 Amerisource Bergen N 20181231 46122-268_5559cb0f-0395-4dc0-8446-ce1cecb5b2a7 46122-268 HUMAN OTC DRUG good neighbor pharmacy cold and flu night time Acetaminophen, diphenhydramine HCl, phenylephrine HCl TABLET, FILM COATED ORAL 20141109 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 46122-269_a3b8d3e3-1ecd-4ef5-a439-5dd33b44e85c 46122-269 HUMAN OTC DRUG good neighbor pharmacy sinus relief day time night time Acetaminophen, guaifenesin, diphenhydramine HCl, phenylephrine HCl KIT 20151023 OTC MONOGRAPH FINAL part341 Amerisource Bergen N 20181231 46122-270_f370d0ee-3d35-409f-a0aa-a1560207b2b9 46122-270 HUMAN OTC DRUG good neighbor pharmacy sinus relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20141221 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 46122-271_f1a3fa5a-8d86-4c02-b81c-343a7e2ede63 46122-271 HUMAN OTC DRUG good neighbor pharmacy sinus relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20141106 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 46122-272_3d52e6d9-f6ae-4a86-8d1a-ee5ac26491aa 46122-272 HUMAN OTC DRUG good neighbor pharmacy severe sinus congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20141221 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 46122-273_4231e1d3-6932-460e-9e9f-36adc3190567 46122-273 HUMAN OTC DRUG Good Neighbor Pharmacy Lice Solution Piperonyl butoxide, pyrethrum extract KIT 20160307 OTC MONOGRAPH FINAL part358G Amerisource Bergen N 20181231 46122-277_309e94ba-4cd7-4479-909c-496db70588e4 46122-277 HUMAN OTC DRUG good neighbor pharmacy multi symptom Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20141223 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 46122-278_60284fba-92df-4c3c-b3a8-c107615d2cd5 46122-278 HUMAN OTC DRUG Sore Throat Menthol Phenol LIQUID ORAL 20140831 OTC MONOGRAPH NOT FINAL part356 AmerisourceBergen (Good Neighbor Pharmacy) 46122 PHENOL 1.4 g/100mL N 20181231 46122-279_8ca6a3b3-9f39-4a36-93f2-7e74c9ac0031 46122-279 HUMAN OTC DRUG Good Neighbor Pharmacy Diaper Rash Zinc Oxide CREAM TOPICAL 20140923 OTC MONOGRAPH FINAL part347 Amerisource Bergen ZINC OXIDE 13 mg/g N 20181231 46122-280_64f8fa34-99a8-4b52-abab-0572576ab702 46122-280 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140930 OTC MONOGRAPH FINAL part347 AmerisourceBergen (Good Neighbor Pharmacy) 46122 WITCH HAZEL 842 mg/mL N 20181231 46122-281_5ee3cb79-5c0c-456f-b5d5-d5a008bbd118 46122-281 HUMAN OTC DRUG good neighbor pharmacy omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150325 NDA NDA022032 Amerisource Bergen OMEPRAZOLE 20 mg/1 N 20181231 46122-283_2da872aa-896c-45e1-a69e-0a7b21f56837 46122-283 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141130 NDA NDA021920 AmerisourceBergen (Good Neighbor Pharmacy) 46122 NAPROXEN SODIUM 220 mg/1 N 20181231 46122-284_4855a442-261a-4397-bf13-7af4ce635e89 46122-284 HUMAN OTC DRUG good neighbor pharmacy nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20141202 ANDA ANDA076777 Amerisource Bergen NICOTINE 2 mg/1 N 20181231 46122-286_30e45b9c-817a-4fdc-b7f1-20bd285519b9 46122-286 HUMAN OTC DRUG good neighbor pharmacy nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20141022 ANDA ANDA076779 Amerisource Bergen NICOTINE 4 mg/1 N 20181231 46122-287_cbdf3a82-aec5-4890-bd45-16b37c98c20e 46122-287 HUMAN OTC DRUG Good Neighbor Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20141127 ANDA ANDA076789 Amerisource Bergen NICOTINE 4 mg/1 N 20181231 46122-289_b309af55-2918-459a-9b96-e4a33379cf95 46122-289 HUMAN OTC DRUG good neighbor pharmacy cleartime Loratadine TABLET ORAL 20150325 ANDA ANDA076301 Amerisource Bergen LORATADINE 10 mg/1 N 20181231 46122-292_9d43655d-0abd-4cec-9ff8-d3a469817e0d 46122-292 HUMAN OTC DRUG Good Neighbor Pharmacy Aspirin Aspirin TABLET ORAL 20150220 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ASPIRIN 325 mg/1 N 20181231 46122-293_e9ea3884-cbcf-4a45-9053-73222cd7c2d9 46122-293 HUMAN OTC DRUG Good Neighbor Pharmacy Cough DM ER dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150419 ANDA ANDA091135 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 46122-294_b71187f4-4096-4ae2-824a-51e8891e0128 46122-294 HUMAN OTC DRUG Good Neighbor Pharmacy Cough DM ER Childrens Dextromethorphan polistirex SUSPENSION ORAL 20150510 ANDA ANDA091135 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 46122-295_99c6175f-c5b3-4442-b20f-8747da1e13ec 46122-295 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus Relief Severe Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20150216 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 46122-296_50dfc164-4c4f-4760-8082-6b9033dc7f5f 46122-296 HUMAN OTC DRUG Good Neighbor Pharmacy Nausea Relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20160509 UNAPPROVED DRUG OTHER Amerisource Bergen DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 46122-297_2b16f283-c069-4f26-9b19-f87612eae4c6 46122-297 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20150731 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN 500 mg/1 N 20181231 46122-298_daefac4b-4728-447c-8425-a21979e75ea8 46122-298 HUMAN OTC DRUG Good Neighbor Pharmacy Cold Multi Symptom acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20151026 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 46122-299_9998430f-eb14-4a6e-815c-8673189470de 46122-299 HUMAN OTC DRUG Good Neighbor Pharmacy Tussin Guaifenesin SYRUP ORAL 20150624 OTC MONOGRAPH FINAL part341 Amerisource Bergen GUAIFENESIN 200 mg/10mL N 20181231 46122-301_5afec4fd-db14-4268-b9b6-8b0994c991b9 46122-301 HUMAN OTC DRUG good neighbor pharmacy severe night time acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl TABLET, FILM COATED ORAL 20150903 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 46122-302_e243ceb9-1818-4073-981d-8e4b69532898 46122-302 HUMAN OTC DRUG Childrens Triacting Night Time Cold and Cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 46122-303_f13212e2-f2ef-42fd-b85e-ccb2dedcf396 46122-303 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 650; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 46122-305_ba8cb282-fa29-460a-aa15-c5e910fcce02 46122-305 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 46122-306_c0f62f42-5080-4cfa-95b5-da38d24d11f1 46122-306 HUMAN OTC DRUG Stomach Relief Original Strength Bismuth subsalicylate LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part335 AmerisourceBergen (Good Neighbor Pharmacy) 46122 BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 46122-308_7462fd33-8173-46cd-af7c-f9266bff8d0a 46122-308 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part335 AmerisourceBergen (Good Neighbor Pharmacy) 46122 BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 46122-309_7f6683d1-7a32-4a04-9402-1042537f896d 46122-309 HUMAN OTC DRUG good neighbor pharmacy naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20150803 ANDA ANDA074661 Amerisource Bergen NAPROXEN SODIUM 220 mg/1 N 20181231 46122-310_3de37772-f7e4-405e-85b9-22d421f17609 46122-310 HUMAN OTC DRUG Childrens Plus Multi Symptom Cold Dye Free Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride SUSPENSION ORAL 20150831 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 46122-311_bda4169d-59fe-4e60-bc26-a645af90749e 46122-311 HUMAN OTC DRUG Nighttime Flu Relief Therapy Severe Cold Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 46122-312_20037dfb-d2cb-4be9-ba40-c559396a4880 46122-312 HUMAN OTC DRUG Good Neighbor Pharmacy Pain Relief Acetaminophen TABLET, FILM COATED ORAL 20151109 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 500 mg/1 N 20181231 46122-313_09d0c563-d291-407c-9d38-02c931e6de40 46122-313 HUMAN OTC DRUG Pain Relief Infants Acetaminophen SUSPENSION ORAL 20151031 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN 160 mg/5mL N 20181231 46122-316_f586d2c2-163f-4732-9de4-26f34013e156 46122-316 HUMAN OTC DRUG Good Neighbor Pharmacy Severe Cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20160827 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 46122-317_63e47de4-f78f-4a9d-94b1-1dbcaf0ffe4c 46122-317 HUMAN OTC DRUG good neighbor pharmacy antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160517 OTC MONOGRAPH FINAL part331 Amerisource Bergen CALCIUM CARBONATE 750 mg/1 N 20181231 46122-318_61570412-062a-4ed7-b3cf-630ea5f2174e 46122-318 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160307 OTC MONOGRAPH FINAL part331 Amerisource Bergen CALCIUM CARBONATE 750 mg/1 N 20181231 46122-319_96cd9203-b822-4f4d-bc85-14dea5fa5b8a 46122-319 HUMAN OTC DRUG Good Neighbor Pharmacy Antacid calcium carbonate TABLET, CHEWABLE ORAL 20160307 OTC MONOGRAPH FINAL part331 Amerisource Bergen CALCIUM CARBONATE 750 mg/1 N 20181231 46122-320_3c7f973f-b6fc-4db9-8207-cb8d06b8f5d2 46122-320 HUMAN OTC DRUG good neighbor pharmacy antacid calcium carbonate TABLET, CHEWABLE ORAL 20160411 OTC MONOGRAPH FINAL part331 Amerisource Bergen CALCIUM CARBONATE 1000 mg/1 N 20181231 46122-321_cdd5287e-2a0f-43fe-9d3e-6525cd88c4b8 46122-321 HUMAN OTC DRUG Good Neighbor Pharmcy Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160307 OTC MONOGRAPH FINAL part331 Amerisource Bergen CALCIUM CARBONATE 1000 mg/1 N 20181231 46122-322_b65ebe98-16dc-474e-a379-b767c0e7c041 46122-322 HUMAN OTC DRUG good neighbor pharmacy pain and fever childrens Acetaminophen SUSPENSION ORAL 20150923 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL N 20181231 46122-323_bc32fb81-ae01-4ee8-af76-83e404458f7d 46122-323 HUMAN OTC DRUG good neighbor pharmacy pain and fever childrens Acetaminophen SUSPENSION ORAL 20150923 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/5mL N 20181231 46122-324_1ce10232-fdcf-4315-9bd3-068db3f2ae72 46122-324 HUMAN OTC DRUG Cough Relief Adult Dextromethorphan HBr LIQUID ORAL 20151130 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 46122-325_d7aa1eac-ff47-4c23-a73f-7851e69353ac 46122-325 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150930 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 46122-326_b945e707-03f2-4169-a752-756d4e8123fc 46122-326 HUMAN OTC DRUG Cold and Flu Relief Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20151130 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 46122-327_2d2b69a7-b22b-4bd2-ac67-429b907e34cd 46122-327 HUMAN OTC DRUG Triacting Day Time Cold and Cough Childrens Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 46122-328_a58e624b-ae9e-465d-adad-98ffdab6b5b3 46122-328 HUMAN OTC DRUG GNP Isopropyl Alcohol 50 Percent isopropyl alcohol LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen ISOPROPYL ALCOHOL 500 mg/mL N 20181231 46122-329_5e1b3940-bc53-8ad4-e053-2a91aa0a34cf 46122-329 HUMAN OTC DRUG GNP Ethyl Rubbing Alcohol 70 Percent ethyl alcohol LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen ALCOHOL 700 mg/mL N 20181231 46122-330_5e20cda5-11f3-3a12-e053-2991aa0aa951 46122-330 HUMAN OTC DRUG GNP Isopropyl Rubbing Alcohol 70 Percent Isopropyl alcohol LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen ISOPROPYL ALCOHOL 700 mg/mL N 20181231 46122-331_5e20cda5-1204-3a12-e053-2991aa0aa951 46122-331 HUMAN OTC DRUG GNP Isopropyl Alcohol 70 Percent With Wintergreen Oil isopropyl alcohol LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen ISOPROPYL ALCOHOL 700 mg/mL N 20181231 46122-332_5e1c86c6-617a-5290-e053-2a91aa0a89fe 46122-332 HUMAN OTC DRUG GNP Isopropyl Alcohol 91 Percent isopropyl alcohol LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen ISOPROPYL ALCOHOL 910 mg/mL N 20181231 46122-333_33ef902e-5a58-4e64-8491-648f14333872 46122-333 HUMAN OTC DRUG GNP Isopropyl Alcohol 50 Percent With Wintergreen Oil isopropyl alcohol LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen ISOPROPYL ALCOHOL 500 mg/mL N 20181231 46122-334_5e1bbad0-3947-07b3-e053-2991aa0a6009 46122-334 HUMAN OTC DRUG GNP Hydrogen Peroxide 3 Percent hydrogen peroxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Amerisource Bergen HYDROGEN PEROXIDE 30 mg/mL N 20181231 46122-335_5e1eb691-00d9-0f3f-e053-2991aa0ac3fb 46122-335 HUMAN OTC DRUG GNP Witch Hazel Witch Hazel LIQUID TOPICAL 20160101 OTC MONOGRAPH FINAL part347 Amerisource Bergen WITCH HAZEL 855 mg/mL N 20181231 46122-336_dc29773d-6330-4e62-b3f1-90b512162d23 46122-336 HUMAN OTC DRUG Severe Cold and Cough Relief Daytime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20151231 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 46122-337_4cca1ba3-02da-4325-840c-48c09f23c6a3 46122-337 HUMAN OTC DRUG Good Neighbor Pharmacy Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER AmerisourceBergen Drug Corp PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 46122-338_7a434ceb-c0f9-4d59-a3f5-2eab61dfc498 46122-338 HUMAN OTC DRUG Good Neighbor Pharmacy Fluticasone Propionate Fluticasone propionate SPRAY, METERED NASAL 20160529 ANDA ANDA207957 Amerisource Bergen FLUTICASONE PROPIONATE 50 ug/1 N 20181231 46122-339_8af845c1-c48c-4620-9579-743c16aa1a59 46122-339 HUMAN OTC DRUG Cold Flu Relief Daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20151130 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 46122-340_56054ff1-d0bf-4855-a881-b8f5ade576a5 46122-340 HUMAN OTC DRUG Infants Pain Relief Acetaminophen SUSPENSION ORAL 20160114 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN 160 mg/5mL N 20181231 46122-341_a4bf33fa-c93d-4b56-9283-3cbadea40942 46122-341 HUMAN OTC DRUG Good Neighbor Pharmacy Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20160321 ANDA ANDA206581 Amerisource Bergen IBUPROFEN SODIUM 256 mg/1 N 20181231 46122-342_e845e2a5-2f57-4b88-9280-393edbd63ecc 46122-342 HUMAN OTC DRUG Laxative Pills Extra Strength Sennosides TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 SENNOSIDES 25 mg/1 N 20181231 46122-343_75f1013d-a1ec-4d56-be9d-98dc5e5d010b 46122-343 HUMAN OTC DRUG Senna Plus DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 46122-344_df295f3e-08a6-4b51-a4bb-cdc881215846 46122-344 HUMAN OTC DRUG Stool Softener Stimulant laxative docusate sodium and sennosides TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 46122-345_b7453c0e-b452-409b-a324-83fdd105bfd0 46122-345 HUMAN OTC DRUG Good Neighbor Pharmacy Dual Action Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160129 ANDA ANDA077355 Amerisource Bergen FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 46122-346_178791b7-da25-4bc1-855e-27cacb0e0f4f 46122-346 HUMAN OTC DRUG Good Neighbor Pharmacy Dual Action Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20160129 ANDA ANDA077355 Amerisource Bergen FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 46122-347_4b1ed49f-b6f4-48c8-99f4-cbce245b207c 46122-347 HUMAN OTC DRUG Good Neighbor Pharmacy Nasal Oxymetazoline hydrochloride SPRAY NASAL 20160711 OTC MONOGRAPH FINAL part341 Amerisource Bergen OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 46122-348_5f205cb9-1aa1-4b5d-86ee-5a1c1e08d14d 46122-348 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160815 ANDA ANDA091070 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 46122-351_1e99f1a3-95bc-4108-8395-430a32c4f292 46122-351 HUMAN OTC DRUG Good Neighbor Pharmacy Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160321 ANDA ANDA091009 Amerisource Bergen GUAIFENESIN 1200 mg/1 N 20181231 46122-352_957b7258-38a7-9f6d-dcf5-d8c1e8feb06b 46122-352 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20160720 ANDA ANDA074612 AmerisourceBergen Drug Corporation NICOTINE 14 mg/24h N 20181231 46122-353_957b7258-38a7-9f6d-dcf5-d8c1e8feb06b 46122-353 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20160720 ANDA ANDA074612 AmerisourceBergen Drug Corporation NICOTINE 21 mg/24h N 20181231 46122-354_957b7258-38a7-9f6d-dcf5-d8c1e8feb06b 46122-354 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20160720 ANDA ANDA074612 AmerisourceBergen Drug Corporation NICOTINE 7 mg/24h N 20181231 46122-356_ba005f42-b1de-44d7-a728-d3d6153b87af 46122-356 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride SOLUTION ORAL 20160518 OTC MONOGRAPH FINAL part341 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/20mL N 20181231 46122-357_92452fd4-cdf6-4ff9-8f42-c7d1c79fb707 46122-357 HUMAN OTC DRUG Extra Strength Pain Relief acetaminophen LIQUID ORAL 20160518 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 500 mg/15mL N 20181231 46122-358_5e3ba822-6c1a-4693-89bb-0c921296afe3 46122-358 HUMAN OTC DRUG Pain Plus Sleep acetaminophen, diphenhydramine hydrochloride LIQUID ORAL 20160519 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/15mL; mg/15mL N 20181231 46122-359_53b5e704-b3eb-4b1b-9463-a80edf8dcb18 46122-359 HUMAN OTC DRUG Fast Maximum Night Time Cold and Flu Acetaminophen, Diphenhydramine hydrochloride and Phenylephrine hydrochloride SOLUTION ORAL 20160523 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 46122-360_98953d62-7f35-4cf8-88ba-897114a0a18f 46122-360 HUMAN OTC DRUG Fast Maximum Severe Congestion and Cough Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20160519 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 46122-361_a30480e9-ee68-4c12-85f8-a13dd4c6fca2 46122-361 HUMAN OTC DRUG Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20160520 OTC MONOGRAPH FINAL part341 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 46122-362_2904d2ed-0cd2-4860-b657-bbcac6108cb1 46122-362 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20160701 OTC MONOGRAPH FINAL part358F AmerisourceBergen Drug Corporation SALICYLIC ACID .17 g/9mL N 20181231 46122-363_2e728b3e-7be3-40f2-9550-3f223760e179 46122-363 HUMAN OTC DRUG Good Neighbor Pharmacy Mineral Oil Laxative Mineral Oil ENEMA RECTAL 20160315 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen MINERAL OIL 118 g/118mL N 20181231 46122-364_6bb06cd9-cd86-4747-aeba-b3a2c400ac6e 46122-364 HUMAN OTC DRUG Good Neighbor Pharmacy Single Saline Laxative Laxative SODIUM PHOSPHATE, DIBASIC and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM ENEMA RECTAL 20160315 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 7; 19 g/118mL; g/118mL N 20181231 46122-368_7b8ff5f9-a226-4f3e-8ad4-26e954fc6727 46122-368 HUMAN OTC DRUG Good Neighbor Pharmacy Athletes foot relief tolnaftate SPRAY TOPICAL 20161107 OTC MONOGRAPH FINAL part333C Amerisource Bergen TOLNAFTATE 1 g/100g N 20181231 46122-369_c2a24f12-756f-425d-87b7-1bc81361e835 46122-369 HUMAN OTC DRUG Good Neighbor Pharmacy athletes foot relief Tolnaftate SPRAY TOPICAL 20160906 OTC MONOGRAPH FINAL part333C Amerisource Bergen TOLNAFTATE 1 g/100g N 20181231 46122-370_188c9a1a-8d5f-4522-b9f3-221a3dd8c1ca 46122-370 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20160531 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN 500 mg/1 N 20181231 46122-371_b1ecf23b-780e-45fa-9222-26105fe8e4aa 46122-371 HUMAN OTC DRUG Mucus Relief DM Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20160531 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 46122-375_3f183c1b-2266-4854-a3ef-a35bd5d01825 46122-375 HUMAN OTC DRUG Good Neoghbor Pharmacy Tussin DM MAX Nighttime Cough dextromethorphan hbr, doxylamine succinate SOLUTION ORAL 20160825 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL N 20181231 46122-376_0f6a6cff-8545-47a2-b03a-509462f608a6 46122-376 HUMAN OTC DRUG GNP Lubricating Relief Eye Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20160930 OTC MONOGRAPH FINAL part349 Amerisource Bergen POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 46122-377_feffc1e7-e3c3-4443-986c-7feb44edf011 46122-377 HUMAN OTC DRUG GNP Lubricating Relief Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20160930 OTC MONOGRAPH FINAL part349 AmerisourceBergen Drug Corporation CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 46122-378_c7995986-50ec-4043-8d57-6596cb4f78c0 46122-378 HUMAN OTC DRUG Good Neighbor Pharmacy Redness Relief Glycerin and Naphazoline SOLUTION/ DROPS OPHTHALMIC 20170324 OTC MONOGRAPH FINAL part349 Amerisource Bergen GLYCERIN; NAPHAZOLINE HYDROCHLORIDE .0025; .00012 mg/mL; mg/mL N 20181231 46122-380_c43e4c4f-d75d-433a-8cca-8495223b1d7b 46122-380 HUMAN OTC DRUG Good Neighbor Pharmacy Athletes Foot Relief Miconazole Nitrate SPRAY TOPICAL 20170403 OTC MONOGRAPH FINAL part333C Amerisource Bergen MICONAZOLE NITRATE 2 g/100g N 20181231 46122-382_09e0f5ed-51af-4077-adf3-dc9c0be2ba54 46122-382 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20160930 OTC MONOGRAPH NOT FINAL part343 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20191231 46122-383_96635cb0-8c78-4c3a-8294-2804ff26f90a 46122-383 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20170802 ANDA ANDA076557 AMERISOURCE BERGEN LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 46122-384_8fa935e6-f7ec-45ab-bb04-3920175f5316 46122-384 HUMAN OTC DRUG Good Neighbor Pharmacy Gentle Laxative Bisacodyl SUPPOSITORY RECTAL 20150213 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen Drug Corp BISACODYL 10 mg/2000mg N 20181231 46122-385_8e9dbe87-b0d5-414a-b725-84023c5fc471 46122-385 HUMAN OTC DRUG Good Neighbor Pharmacy 24 Hour Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20161024 ANDA ANDA078104 Amerisource Bergen TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 46122-386_028983a6-1ce6-4fe5-bb46-360a57a80df5 46122-386 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20161010 ANDA ANDA207957 Amerisource Bergen FLUTICASONE PROPIONATE 50 ug/1 N 20181231 46122-387_179cbace-1755-408c-ab6e-4844c017ace9 46122-387 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20150115 ANDA ANDA202039 Amerisource Bergen FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 46122-388_f5e4dc6c-ef15-24ce-8d8b-4c10b820e53d 46122-388 HUMAN OTC DRUG Acetaminophen Acetaminophen CAPSULE, LIQUID FILLED ORAL 20170201 OTC MONOGRAPH NOT FINAL part343 AMERISOURCEBERGEN DRUG CORPORATION ACETAMINOPHEN 500 mg/1 N 20181231 46122-389_2c65e6a8-f828-3db2-df04-676dee56b6ad 46122-389 HUMAN OTC DRUG Budesonide Budesonide SPRAY, METERED NASAL 20160915 ANDA ANDA078949 Amerisource Bergen BUDESONIDE 32 ug/1 N 20181231 46122-390_4180c1d6-1a98-470e-e054-00144ff88e88 46122-390 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen TABLET ORAL 20110629 OTC MONOGRAPH NOT FINAL part343 AmeriSource Bergen ACETAMINOPHEN 325 mg/1 N 20181231 46122-393_47abb15b-efcb-442e-b622-1feece48cd1a 46122-393 HUMAN OTC DRUG Good Neighbor Pharmacy Jock Itch Relief Miconazole Nitrate SPRAY TOPICAL 20170406 OTC MONOGRAPH FINAL part333C Amerisource Bergen MICONAZOLE NITRATE 2 g/100g N 20181231 46122-394_030d5f5a-16e1-4332-b2ea-8677f9f8edb4 46122-394 HUMAN OTC DRUG Good Neighbor Pharmacy Acid Reducer Famotidine TABLET ORAL 20161212 ANDA ANDA075400 Amerisource Bergen FAMOTIDINE 10 mg/1 N 20181231 46122-395_deb85c13-4ac1-44ee-a469-e972ac9380d7 46122-395 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20161130 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 MINERAL OIL 100 mg/100mL N 20181231 46122-396_0ff3d2c4-0fb3-452f-9b62-6edd34e618c5 46122-396 HUMAN OTC DRUG Senna laxative Sennosides TABLET ORAL 20161130 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 SENNOSIDES 8.6 mg/1 N 20181231 46122-397_0562a1e8-daf1-4b71-b0dd-aa8287b2e9b0 46122-397 HUMAN OTC DRUG Good Neighbor Pharmacy Esomeprazole Magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170922 ANDA ANDA207193 Amerisource Bergen ESOMEPRAZOLE 20 mg/1 N 20181231 46122-399_58fff711-3203-67ef-e053-2a91aa0a4d44 46122-399 HUMAN OTC DRUG Stool Softener Liquid Docusate sodium LIQUID ORAL 20170901 OTC MONOGRAPH NOT FINAL part334 AMERISOURCEBERGEN DRUG CORPORATION DOCUSATE SODIUM 50 mg/5mL N 20181231 46122-400_5bc0844f-6d18-ae91-e053-2991aa0ae403 46122-400 HUMAN OTC DRUG Stool Softener Syrup Docusate sodium SYRUP ORAL 20170901 OTC MONOGRAPH NOT FINAL part334 AMERISOURCEBERGEN DRUG CORPORATION DOCUSATE SODIUM 60 mg/15mL N 20181231 46122-402_4fbf9f3f-8376-484f-9bbd-924101dc3926 46122-402 HUMAN OTC DRUG Good Neighbor Pharmacy Flu and Severe Cold and Cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20170322 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 46122-404_baefb694-b000-483f-b42f-3337f9f9a7b5 46122-404 HUMAN OTC DRUG Good Neighbor Pharmacy Night Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20170522 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 46122-408_86601f32-9597-4e8a-95a1-4e7d174cfd82 46122-408 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY CLEANSING PADS WITCH HAZEL SOLUTION RECTAL; TOPICAL 20110601 OTC MONOGRAPH FINAL part346 AMERISOURCE BERGEN WITCH HAZEL .5 mL/mL N 20181231 46122-414_b0c9e6cc-8bf8-46ed-888d-c022858dd2b0 46122-414 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20151215 OTC MONOGRAPH FINAL part333B AmerisourceBergen BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 46122-416_b742218f-8061-49cc-9cfe-c8d984343c1c 46122-416 HUMAN OTC DRUG Mucus Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170821 NDA NDA021282 AMERISOURCEBERGEN DRUG CORPORATION GUAIFENESIN 600 mg/1 N 20181231 46122-417_b36cda0a-f24c-496b-89f1-b8c4f819dbbf 46122-417 HUMAN OTC DRUG Mucus Extended Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170821 NDA NDA021282 AMERISOURCEBERGEN DRUG CORPORATION GUAIFENESIN 1200 mg/1 N 20181231 46122-419_cad83cb3-34f7-4067-b37f-226e4bf1e41c 46122-419 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20170531 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 46122-420_bf4bcec8-7136-4ae7-a459-a30ee881b98d 46122-420 HUMAN OTC DRUG Mucus DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Amerisource Bergen GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 46122-423_f8905ca0-2fa9-422e-a42d-7d2b99a07775 46122-423 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 AmerisourceBergen LORATADINE 5 mg/5mL N 20181231 46122-424_e312fc3b-4a74-432c-ac1f-8e936752f051 46122-424 HUMAN OTC DRUG Pain Relief Childrens acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 160 mg/1 N 20181231 46122-425_dec68663-9842-48c1-a363-1eab1625cdbe 46122-425 HUMAN OTC DRUG Allergy Relief diphenhydramine HCl TABLET, CHEWABLE ORAL 20110425 OTC MONOGRAPH FINAL part341 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20181231 46122-426_d12623bb-5cff-4e89-8c4e-c322d7d3319a 46122-426 HUMAN OTC DRUG Cough Gels dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Amerisource Bergen DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 46122-427_2a4804e0-eafe-4e1a-ad48-075eeda68d48 46122-427 HUMAN OTC DRUG Allergy Relief DYE-FREE Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 46122-428_a184eb1d-9244-4d62-ab2e-877da3e4cff8 46122-428 HUMAN OTC DRUG Nasal Decongestant Maximum Strength, Non-Drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 19810825 OTC MONOGRAPH FINAL part341 Amerisource Bergen PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 46122-429_4657604a-6e29-4bb1-9e5f-79a62501dbb1 46122-429 HUMAN OTC DRUG Womens Gentle Laxative Bisacodyl TABLET, COATED ORAL 20130401 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen BISACODYL 5 mg/1 N 20181231 46122-430_2a0f64b2-bba5-4651-b242-2a7e74fed379 46122-430 HUMAN OTC DRUG Acetaminophen Regular Strength Acetaminophen TABLET ORAL 20150724 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN 325 mg/1 N 20181231 46122-431_5d7ed603-c833-5278-e053-2991aa0aa58a 46122-431 HUMAN OTC DRUG ANTACID ANTIGAS NTA aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 20170901 OTC MONOGRAPH FINAL part331 AMERISOURCEBERGEN DRUG CORPORATION ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 46122-432_5d68a002-3cdc-b2ce-e053-2991aa0a98c9 46122-432 HUMAN OTC DRUG ANTACID ANTIGAS NTA aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 20170901 OTC MONOGRAPH FINAL part331 AMERISOURCEBERGEN DRUG CORPORATION ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 46122-433_5e1eedea-773f-ae8f-e053-2a91aa0a7e99 46122-433 HUMAN OTC DRUG REGULAR STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part331 AMERISOURCEBERGEN DRUG CORPORATION ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 46122-434_5d6835fb-83fc-144b-e053-2a91aa0aeb62 46122-434 HUMAN OTC DRUG REGULAR STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20170901 OTC MONOGRAPH FINAL part331 AMERISOURCEBERGEN DRUG CORPORATION ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 46122-435_5d7f1c70-b23a-7d4e-e053-2a91aa0a7bba 46122-435 HUMAN OTC DRUG MILK OF MAGNESIA CHERRY magnesium hydroxide LIQUID ORAL 20170901 OTC MONOGRAPH NOT FINAL part334 AMERISOURCEBERGEN DRUG CORPORATION MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 46122-436_5d6a973e-a805-0beb-e053-2a91aa0a163d 46122-436 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20170901 OTC MONOGRAPH NOT FINAL part334 AMERISOURCEBERGEN DRUG CORPORATION MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 46122-437_5d687860-adf4-4caa-e053-2a91aa0aef3c 46122-437 HUMAN OTC DRUG MILK OF MAGNESIA magnesium hydroxide LIQUID ORAL 20170901 OTC MONOGRAPH NOT FINAL part334 AMERISOURCEBERGEN DRUG CORPORATION MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 46122-440_e8d42de0-a8dc-48ac-bc7e-4809229e0235 46122-440 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 46122-441_d95385ca-26c2-44ba-b739-45254e9ae63c 46122-441 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, FILM COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 Amerisource Bergen DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 46122-443_c21853c1-5d37-4638-9735-87a21c05673a 46122-443 HUMAN OTC DRUG Sinus Pressure Pain Maximum Strength, Non-Drowsy Acetaminophen, Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 46122-444_9c6113be-088e-4709-8d7c-eb2fdb67edb7 46122-444 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Powder Miconazole Nitrate Talc Free POWDER TOPICAL 20170808 OTC MONOGRAPH FINAL part333C AmerisourceBergen Drug Corporation MICONAZOLE NITRATE 1.42 g/71g N 20181231 46122-447_45c2f451-62d3-4dec-ac34-b3f6a17f9829 46122-447 HUMAN OTC DRUG good neighbor pharmacy tussin CF Max Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20171216 OTC MONOGRAPH FINAL part341 Amerisource Bergen ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20191231 46122-450_f7622be8-a7aa-4c4e-bb9b-eabe2482eddc 46122-450 HUMAN OTC DRUG PAIN RELIEF PATCHES LIDOCAINE PATCH TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part348 Amerisource Bergen LIDOCAINE 4 g/100g N 20181231 46122-451_114ad73a-0a88-435e-bf53-de4e3518bc9c 46122-451 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20171001 OTC MONOGRAPH NOT FINAL part334 AmerisourceBergen (Good Neighbor Pharmacy) 46122 DOCUSATE SODIUM 100 mg/1 N 20191231 46122-456_20642a47-76e6-4512-bc1a-50c2b6aec8ae 46122-456 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Aspirin, Diphenhydramine citrate TABLET, FILM COATED ORAL 20160831 OTC MONOGRAPH NOT FINAL part343 Amerisource Bergen ACETAMINOPHEN; ASPIRIN; DIPHENHYDRAMINE CITRATE 250; 250; 38 mg/1; mg/1; mg/1 N 20181231 46122-457_13397695-8463-437e-ac4c-9b89581cddc8 46122-457 HUMAN OTC DRUG Alert Aid Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 Amerisource Bergen CAFFEINE 200 mg/1 N 20181231 46122-459_f6e84aa8-0837-4c5d-85be-6033fdab2523 46122-459 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part332 Amerisource Bergen DIMETHICONE 125 mg/1 N 20181231 46122-500_bec4d347-c500-421f-97d5-1d648125ec4f 46122-500 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 46122-501_12d16d19-2ee6-42e1-a075-6d780aa5a3e9 46122-501 HUMAN OTC DRUG Good Neighbor Pharmacy Cold Sore Treatment Benzocaine OINTMENT TOPICAL 20170110 OTC MONOGRAPH NOT FINAL part348 Good Neighbor Pharmacy BENZOCAINE 5 mg/g N 20181231 46122-524_641d56ee-a0e7-4c4d-9da6-9a92ffb0de91 46122-524 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20171221 OTC MONOGRAPH FINAL part358F AmerisourceBergen Drug Corporation SALICYLIC ACID 40 mg/41 N 20181231 46122-525_f7bc551f-c16d-404f-9b46-8ad0586cad49 46122-525 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part333A AmerisourceBergen Drug Corporation BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/9mL; mg/9mL N 20181231 46122-526_7d6eda97-857d-41d8-b98d-6092b50e07c7 46122-526 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20171221 OTC MONOGRAPH FINAL part358F AmerisourceBergen Drug Corporation SALICYLIC ACID 40 mg/91 N 20181231 46122-600_9788c057-665e-4352-b03a-022259e5ae76 46122-600 HUMAN OTC DRUG Good Neighbor Mineral Oil Laxative mineral oil ENEMA RECTAL 20120716 OTC MONOGRAPH NOT FINAL part334 Amerisource Bergen MINERAL OIL 118 mL/118mL E 20171231 46122-604_090872f9-1e84-4ff4-a8e7-3c99f744586e 46122-604 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20150630 OTC MONOGRAPH FINAL part341 AmerisourceBergen (Good Neighbor Pharmacy) 46122 ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 46123-001_d4baf0e3-f497-4848-9bcf-f8824a145899 46123-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19670101 NDA NDA205849 Roberts Oxygen Company, Inc. OXYGEN 990 mL/L N 20181231 46123-002_38a4f8f5-28d5-4ebf-9804-93137f488951 46123-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19670101 NDA NDA205849 Roberts Oxygen Company, Inc. OXYGEN 990 mL/L N 20181231 46123-003_40b5b154-c65e-447c-9d0a-9182233d9b87 46123-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19670101 NDA NDA205850 Roberts Oxygen Company, Inc NITROGEN 990 mL/L N 20181231 46123-004_6c475ec7-fbe3-48c8-af2a-9580f94bc5b4 46123-004 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19670101 NDA NDA205850 Roberts Oxygen Company, Inc NITROGEN 990 mL/L N 20181231 46123-005_e987c7a6-0c40-43a2-9abe-9fec19a6055c 46123-005 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 19670101 NDA NDA205764 Roberts Oxygen Company, Inc. CARBON DIOXIDE 990 g/kg Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-006_1d821204-19e9-432f-add7-5d67d39669f9 46123-006 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19670101 NDA NDA206009 Roberts Oxygen Company, Inc. NITROUS OXIDE 990 mL/L N 20181231 46123-007_d491a262-ddfa-454a-a808-e7f1cc6d4677 46123-007 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19670101 NDA NDA206009 Roberts Oxygen Company, Inc. NITROUS OXIDE 990 mL/L N 20181231 46123-008_a1568946-72c2-488b-9105-03c814779352 46123-008 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19670101 NDA NDA205864 Roberts Oxygen Company, Inc. HELIUM 990 mL/L N 20181231 46123-009_8b4765ea-a56d-40ac-9ae8-0a2909299a30 46123-009 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19670101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 210 mL/L N 20181231 46123-010_9676e970-b414-46bd-af91-0b021853a771 46123-010 HUMAN PRESCRIPTION DRUG Oxygen-Helium Mixture Oxygen-Helium Mixture GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 210 mL/L N 20181231 46123-011_74631d92-a377-49fd-a0cd-382766d9f8ca 46123-011 HUMAN PRESCRIPTION DRUG Oxygen-Helium Mixture Oxygen-Helium Mixture GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 250 mL/L N 20181231 46123-012_37922097-76ea-44a1-a294-39d3b6aadfe2 46123-012 HUMAN PRESCRIPTION DRUG Oxygen-Helium Mixture Oxygen-Helium Mixture GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 300 mL/L N 20181231 46123-013_a90ba065-69eb-46e8-abf4-e3d7c6094f89 46123-013 HUMAN PRESCRIPTION DRUG Oxygen-Helium Mixture Oxygen-Helium Mixture GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 330 mL/L N 20181231 46123-014_6b455fd7-0da6-483c-8c2c-7c83523d183d 46123-014 HUMAN PRESCRIPTION DRUG Oxygen-Helium Mixture Oxygen-Helium Mixture GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 400 mL/L N 20181231 46123-015_186a27a9-10c2-4110-82da-119625781a96 46123-015 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Air Mixture Carbon Dioxide-Air Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 50; 210 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-016_41c94166-a86f-478c-b649-0cb41e06aafa 46123-016 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Air Mixture Carbon Dioxide-Air Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 70; 210 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-017_91381ef5-247e-4c2d-a6cc-aea0c44e9684 46123-017 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Air Mixture Carbon Dioxide-Air Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 80; 210 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-018_80a0a565-c3fa-46fd-a151-b2f9d8221552 46123-018 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Air Mixture Carbon Dioxide-Air Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 100; 210 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-019_5677d368-b5cf-4719-8049-307e9028afb9 46123-019 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 50; 950 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-020_15eab8aa-dcd4-4cfe-bb05-c22c3527d07d 46123-020 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 70; 930 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-021_85dd8279-28bf-417a-8991-3c4cd42d15ad 46123-021 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 100; 900 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-022_4b848444-a38d-4473-9ddf-d806bd33fc76 46123-022 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 120; 880 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-023_5071b279-e676-465f-b056-ce58c24c6d08 46123-023 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 150; 850 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-024_38ec80f6-e02d-436b-98c1-af4fa3b00566 46123-024 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen Mixture Carbon Dioxide-Oxygen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 200; 800 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-025_327faa0b-d6b5-4a20-9236-10035aa0c706 46123-025 HUMAN PRESCRIPTION DRUG Oxygen-Carbon Dioxide Mixture Oxygen-Carbon Dioxide Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 700; 300 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-026_12b10ea5-21b9-4ebe-951b-acdf89293c9c 46123-026 HUMAN PRESCRIPTION DRUG Oxygen-Carbon Dioxide Mixture Oxygen-Carbon Dioxide Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 800; 200 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-027_3bb49e70-8ca7-4b82-b698-d3a5b97f2779 46123-027 HUMAN PRESCRIPTION DRUG Helium-Oxygen-Nitrogen Mixture Helium-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. HELIUM; OXYGEN 90; 350 mL/L; mL/L N 20181231 46123-028_25abe805-bd0f-487a-999c-b41e71633e2d 46123-028 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 250 mL/L N 20181231 46123-029_5549b904-3696-4093-9bc8-5cb68c588317 46123-029 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 300 mL/L N 20181231 46123-030_97173fb0-a700-417c-911a-c0ef21b2bcd1 46123-030 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 400 mL/L N 20181231 46123-031_222145d9-2195-4c79-a29f-a44b6cf37020 46123-031 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 500 mL/L N 20181231 46123-032_9672fed4-8dd8-4870-87a8-32a273b629b4 46123-032 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 600 mL/L N 20181231 46123-033_d891c784-444a-4baf-94aa-1e913510f078 46123-033 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 800 mL/L N 20181231 46123-034_2844e976-7d26-4d11-a00d-7ed5c30f4b4a 46123-034 HUMAN PRESCRIPTION DRUG Oxygen-Nitrogen Mixture Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN 900 mL/L N 20181231 46123-035_7cef2421-ea9f-408a-981b-e66e9512982a 46123-035 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. CARBON DIOXIDE; OXYGEN 50; 200 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-036_4d78cfb3-7c2f-46c4-91da-b4a44408de73 46123-036 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN; CARBON DIOXIDE 210; 70 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-037_4d57ec5c-da8d-4243-b9c3-3780bd7b51c9 46123-037 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN; CARBON DIOXIDE 350; 50 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-038_50ee5865-71fb-4227-88ab-d672c636716c 46123-038 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN; CARBON DIOXIDE 400; 50 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-039_319f3662-b0be-4d72-9be2-79632fd756f5 46123-039 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN; CARBON DIOXIDE 450; 50 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-040_8fffe9ba-0191-47f1-9d54-8ea03ad26f70 46123-040 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN; CARBON DIOXIDE 330; 70 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-041_733efd73-385c-47c4-a395-4727ef9574cb 46123-041 HUMAN PRESCRIPTION DRUG Carbon Dioxide-Oxygen-Nitrogen Mixture Carbon Dioxide-Oxygen-Nitrogen Mixture GAS RESPIRATORY (INHALATION) 19660101 UNAPPROVED MEDICAL GAS Roberts Oxygen Company, Inc. OXYGEN; CARBON DIOXIDE 250; 100 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-042_3ee321b0-3b08-44ab-8893-d6d00d420c07 46123-042 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20111101 NDA NDA205764 Roberts Oxygen Company, Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46123-044_a95a8d0d-a79c-424e-a85b-011171cc0053 46123-044 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20020701 NDA NDA205850 Roberts Oxygen Company, Inc. NITROGEN 990 mL/L N 20181231 46123-045_20e008c1-422b-4f30-9c20-3050faf9141c 46123-045 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140101 NDA NDA205849 Roberts Oxygen Company, Inc. OXYGEN 990 mL/L N 20181231 46129-200_c045b5a8-b220-4f0a-a831-155b29c19454 46129-200 HUMAN PRESCRIPTION DRUG Antizol fomepizole INJECTION INTRAVENOUS 20090731 NDA NDA020696 PALADIN LABORATORIES (USA) INC FOMEPIZOLE 1 g/mL Antidote [EPC] E 20171231 46144-162_ea916cea-85dd-4b38-8475-a33ab762b9b5 46144-162 HUMAN OTC DRUG ALLEVESS MENTHOL, CAPSAICIN PATCH TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part348 API Solutions, Inc. MENTHOL; CAPSAICIN 5; .05 g/100g; g/100g E 20171231 46144-163_93d31e54-efc5-4357-80cd-3f65a4cb8d5d 46144-163 HUMAN OTC DRUG RELIEVER MENTHOL, CAPSAICIN PATCH TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part348 API Solutions, Inc. MENTHOL; CAPSAICIN 5; .05 g/100g; g/100g E 20171231 46144-941_616f0b1f-b468-4ba0-e053-2991aa0ab38e 46144-941 HUMAN OTC DRUG FESI MENTHOL, CAPSAICIN PATCH TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 API SOLUTIONS INC. MENTHOL; CAPSAICIN 5; .05 g/100g; g/100g N 20181231 46163-300_239d5e8b-2115-47f4-a850-6c2c65aad62a 46163-300 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 20070412 ANDA ANDA078177 Fresenius Medical Care North America SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 46287-003_d3c88178-c4f0-42ec-b05c-af195e69035e 46287-003 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19850730 ANDA ANDA088138 CMP Pharma, Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 46287-006_1c5f49d2-ec5e-462d-a3cd-41c15e12f011 46287-006 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate sodium polystyrene sulfonate SUSPENSION ORAL; RECTAL 19821208 ANDA ANDA087859 CMP Pharma, Inc. SODIUM POLYSTYRENE SULFONATE 15 g/60mL N 20191231 46287-009_08faf623-90db-48c7-8bb5-75ad5f5d7cda 46287-009 HUMAN PRESCRIPTION DRUG Isoniazid isoniazid SOLUTION ORAL 19831111 ANDA ANDA088235 CMP Pharma, Inc. ISONIAZID 50 mg/5mL Antimycobacterial [EPC] N 20181231 46287-010_b629aa5b-c0fc-4ae7-a2d3-bb1bec07a20e 46287-010 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 19950323 ANDA ANDA089595 Carolina Medical Products Company TRIAMCINOLONE ACETONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 46287-012_f5f277bc-f5b1-4f10-be44-25b72a0c8253 46287-012 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate POWDER, FOR SUSPENSION ORAL; RECTAL 19890119 ANDA ANDA089910 CMP Pharma, Inc. SODIUM POLYSTYRENE SULFONATE 1 g/g N 20181231 46287-014_451b0304-847a-41b2-a5d6-8574ce414148 46287-014 HUMAN PRESCRIPTION DRUG Oracit Citric Acid and Sodium Citrate SOLUTION ORAL 19840515 UNAPPROVED DRUG OTHER CMP Pharma, Inc. CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 640; 490 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20191231 46287-015_9a6bcf5e-6fc5-4689-8c5f-91eafcb4aa7d 46287-015 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride amantadine hydrochloride SOLUTION ORAL 20020911 ANDA ANDA075819 CMP Pharma, Inc. AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] E 20171231 46287-020_d707f437-1548-4cf4-98bd-452d7da8f9ff 46287-020 HUMAN PRESCRIPTION DRUG CaroSpir CaroSpir SUSPENSION ORAL 20170804 NDA NDA209478 CMP Pharma, Inc. SPIRONOLACTONE 25 mg/5mL Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 46324-2421_60e1c571-5a30-badd-e053-2a91aa0ada02 46324-2421 HUMAN OTC DRUG Control Anti-Dandrudff PYRITHIONE ZINC SHAMPOO TOPICAL 20111028 OTC MONOGRAPH FINAL part358H AG Hair Ltd. PYRITHIONE ZINC 20 mg/mL N 20181231 46362-001_62feb716-65ac-452c-871c-4384a3df66dc 46362-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860101 NDA NDA205865 Red Ball Oxygen Co., Inc. OXYGEN 992 mL/L N 20181231 46362-002_42ef3a37-9847-4916-81fe-a26670bbd6c9 46362-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19860101 NDA NDA205866 Red Ball Oxygen Co., Inc. NITROGEN 992 mL/L N 20181231 46362-003_32f6a518-17f3-44d1-8c9f-27c498f72971 46362-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19860101 NDA NDA206009 Red Ball Oxygen Co., Inc. NITROUS OXIDE 992 mL/L N 20181231 46362-004_aeda376a-827a-4e3a-a504-72a8d04d58d8 46362-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20110401 NDA NDA205846 Red Ball Oxygen Co., Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 46414-2040_b58fff5a-a82f-4467-b6b9-5eeadd5423b5 46414-2040 HUMAN OTC DRUG Medicaine Sting and Bite Benzocaine SWAB TOPICAL 19861115 UNAPPROVED DRUG OTHER James Alexander Corporation BENZOCAINE; MENTHOL .12; .006 g/.6mL; g/.6mL N 20181231 46414-2222_ae50aae0-d07f-4096-b009-bf424a00f0b5 46414-2222 HUMAN PRESCRIPTION DRUG Amyl Nitrite Amyl Nitrite INHALANT RESPIRATORY (INHALATION) 19790207 UNAPPROVED DRUG OTHER James Alexander Corporation AMYL NITRITE .3 g/.3mL N 20181231 46414-3333_e1c555ea-fbe6-4860-b9d9-52c9ff836317 46414-3333 HUMAN OTC DRUG Ammonia Inhalants Ammonia Inhalants INHALANT RESPIRATORY (INHALATION) 19760214 UNAPPROVED DRUG OTHER James Alexander Corporation AMMONIA .045 g/.3mL N 20181231 46414-7777_de5b90e0-9d57-4584-af07-13f0f4260be2 46414-7777 HUMAN OTC DRUG POVIDONE-IODINE POVIDONE-IODINE SOLUTION TOPICAL 19760214 UNAPPROVED DRUG OTHER James Alexander Corporation POVIDONE-IODINE 10 mg/mL N 20181231 46414-8888_d52699c7-b6cc-424e-8766-017fc4837dee 46414-8888 HUMAN OTC DRUG Benzoin Benzoin SWAB TOPICAL 19761025 UNAPPROVED DRUG OTHER James Alexander Corporation BENZOIN; ALOE; TOLU BALSAM; LIQUIDAMBAR STYRACIFLUA RESIN .6; .12; .24; .48 g/.6mL; g/.12mL; g/.24mL; g/.48mL N 20181231 46437-001_f6b9f960-4f72-4b38-92d1-0b5b67add8a2 46437-001 HUMAN OTC DRUG Tanda pearl professional whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120803 OTC MONOGRAPH FINAL part355 Syneron Beauty Inc. SODIUM FLUORIDE .33 g/133g E 20171231 46581-100_60f770a3-1efd-4e24-986f-a9523c55c10d 46581-100 HUMAN OTC DRUG SALONPAS PAIN RELIEVING Camphor, Menthol, Methyl salicylate PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 19950301 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 7.1; 33; 36 mg/1; mg/1; mg/1 N 20181231 46581-110_4e486e81-74c8-4e2e-ae72-dc76044d9da2 46581-110 HUMAN OTC DRUG Salonpas Camphor, Menthol, Methyl salicylate PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 20150601 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 21.56; 41.73; 69.55 mg/1; mg/1; mg/1 N 20181231 46581-202_d87431c7-67bf-4183-a340-6dbecb237a4b 46581-202 HUMAN OTC DRUG SALONPAS PAIN RELIEVING Camphor, Menthol, Methyl salicylate PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 19980522 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 28.4; 131; 144 mg/1; mg/1; mg/1 N 20181231 46581-210_63eae536-5100-4a81-9471-e5c2985914af 46581-210 HUMAN OTC DRUG Salonpas Camphor, Menthol, Methyl salicylate PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 20160517 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 86.24; 166.92; 278.2 mg/1; mg/1; mg/1 N 20181231 46581-440_e7a0c92a-7d44-460d-8919-c3d13fabe09f 46581-440 HUMAN OTC DRUG Salonpas pain relieving JET Menthol, Methyl salicylate AEROSOL, SPRAY PERCUTANEOUS; TOPICAL; TRANSDERMAL 20110501 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. MENTHOL; METHYL SALICYLATE 3; 10 g/100g; g/100g N 20181231 46581-670_5f2ca1dc-926c-4183-8c3d-0d8e7d3386ea 46581-670 HUMAN OTC DRUG Salonpas Pain Relief Menthol, Methyl Salicylate PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 20080425 NDA NDA022029 Hisamitsu Pharmaceutical Co., Inc. MENTHOL; METHYL SALICYLATE 31.5; 105 mg/1; mg/1 N 20181231 46581-680_7402c10e-f276-4383-bba8-d32ad381b1ed 46581-680 HUMAN OTC DRUG Salonpas Arthritis Pain Menthol, Methyl Salicylate PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 20080425 NDA NDA022029 Hisamitsu Pharmaceutical Co., Inc. MENTHOL; METHYL SALICYLATE 31.5; 105 mg/1; mg/1 N 20181231 46581-700_93e8582f-66d6-4138-8d32-ea3a282ec106 46581-700 HUMAN OTC DRUG SALONPAS-HOT CAPSICUM Capsaicin PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 19981126 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAPSICUM 249 mg/1 N 20181231 46581-730_87f1bc2b-1729-4328-b311-6762c4ff8edf 46581-730 HUMAN OTC DRUG Salonpas pain relieving PATCH HOT Capsaicin OINTMENT PERCUTANEOUS; TOPICAL; TRANSDERMAL 20120101 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAPSICUM OLEORESIN 26.25 mg/1 N 20181231 46581-750_3afe306c-daf8-4735-9b34-fb825de06f46 46581-750 HUMAN OTC DRUG Salonpas pain relieving PATCH HOT LARGE Capsaicin OINTMENT PERCUTANEOUS; TOPICAL; TRANSDERMAL 20120101 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAPSICUM 131.25 mg/1 N 20181231 46581-830_1b0e1245-3a3c-4f97-9be8-237a349a6c2e 46581-830 HUMAN OTC DRUG Salonpas LIDOCAINE Pain Relieving Lidocaine PATCH PERCUTANEOUS; TOPICAL; TRANSDERMAL 20160801 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. LIDOCAINE 560 mg/1 N 20181231 46581-870_44c1d6c6-c10b-4748-a183-e790379487ef 46581-870 HUMAN OTC DRUG Salonpas pain relieving HOT Capsaicin, Menthol PATCH TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAPSICUM; MENTHOL .025; 1.25 g/100g; g/100g N 20181231 46581-871_6a06a129-9ac1-4f0f-a799-738437bf5607 46581-871 HUMAN OTC DRUG Salonpas pain relieving hot Capsaicin, Menthol PATCH TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAPSICUM; MENTHOL .025; 1.25 g/100g; g/100g N 20181231 46581-890_c5d62ed1-3e18-4ba6-aa58-6594f39457dc 46581-890 HUMAN OTC DRUG Salonpas pain relieving HOT-L Capsaicin, Menthol PATCH TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part348 Hisamitsu Pharmaceutical Co., Inc. CAPSICUM; MENTHOL .025; 1.25 g/100g; g/100g N 20181231 46607-111_c37e94a3-550b-4995-85d7-e4c842da748b 46607-111 HUMAN OTC DRUG Dandruff pyrithione zinc SHAMPOO TOPICAL 20160414 OTC MONOGRAPH FINAL part358H Ecocare PYRITHIONE ZINC 9.5 mg/100mL N 20191231 46672-036_6c7ac274-a194-4ac4-ba3a-8a6b5d0b6a89 46672-036 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20060119 ANDA ANDA040658 Mikart, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 46672-053_5caee91f-cf1c-41e9-ade5-5b7d65e46f41 46672-053 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 19870121 ANDA ANDA089175 Mikart, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 46672-092_16919470-c850-4a2b-a457-33eb8c3f5a09 46672-092 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20100609 ANDA ANDA040846 Mikart, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 46672-099_5a0d008b-754a-4e15-bd2f-779ac1f275e8 46672-099 HUMAN PRESCRIPTION DRUG Butapap butalbital and acetaminophen TABLET ORAL 19921026 ANDA ANDA089987 Mikart, Inc. BUTALBITAL; ACETAMINOPHEN 50; 325 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 46672-117_4499f9ad-433b-485d-b523-c2f3bc441ebb 46672-117 HUMAN PRESCRIPTION DRUG chlorzoxazone chlorzoxazone TABLET ORAL 20100601 ANDA ANDA040861 Mikart Inc. CHLORZOXAZONE 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 46672-118_4499f9ad-433b-485d-b523-c2f3bc441ebb 46672-118 HUMAN PRESCRIPTION DRUG chlorzoxazone chlorzoxazone TABLET ORAL 20100601 ANDA ANDA040861 Mikart Inc. CHLORZOXAZONE 375 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 46672-138_b72f962a-379d-419b-9b07-5e1e00893cc9 46672-138 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20000705 ANDA ANDA089452 Mikart, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 46672-147_3db0c45e-adc1-4022-8591-9cd6df699773 46672-147 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20030120 ANDA ANDA040432 Mikart, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 46672-166_6c7ac274-a194-4ac4-ba3a-8a6b5d0b6a89 46672-166 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20060324 ANDA ANDA040556 Mikart, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 46672-174_28b79621-4211-467e-8bc9-852c2be8506f 46672-174 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20000627 ANDA ANDA089452 Mikart, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 46672-191_748c233b-6ab9-42d0-89ab-e7ead30f7947 46672-191 HUMAN PRESCRIPTION DRUG carbinoxamine maleate carbinoxamine maleate TABLET ORAL 20030319 ANDA ANDA040442 Mikart, Inc. CARBINOXAMINE MALEATE 4 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 46672-192_6c7ac274-a194-4ac4-ba3a-8a6b5d0b6a89 46672-192 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20040623 ANDA ANDA040556 Mikart, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 46672-193_4d0bc403-5a2f-4ee5-a78e-f0a5c0c6c8a4 46672-193 HUMAN PRESCRIPTION DRUG oxycodone and acetaminophen oxycodone and acetaminophen TABLET ORAL 20051230 ANDA ANDA040608 Mikart, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 2.5; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46672-194_4d0bc403-5a2f-4ee5-a78e-f0a5c0c6c8a4 46672-194 HUMAN PRESCRIPTION DRUG oxycodone and acetaminophen oxycodone and acetaminophen TABLET ORAL 20051230 ANDA ANDA040608 Mikart, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46672-195_4d0bc403-5a2f-4ee5-a78e-f0a5c0c6c8a4 46672-195 HUMAN PRESCRIPTION DRUG oxycodone and acetaminophen oxycodone and acetaminophen TABLET ORAL 20051230 ANDA ANDA040608 Mikart, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46672-196_4d0bc403-5a2f-4ee5-a78e-f0a5c0c6c8a4 46672-196 HUMAN PRESCRIPTION DRUG oxycodone and acetaminophen oxycodone and acetaminophen TABLET ORAL 20051230 ANDA ANDA040608 Mikart, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46672-198_43f91528-2568-41b0-b08e-1731ca1bf864 46672-198 HUMAN PRESCRIPTION DRUG ergotamine tartrate and caffeine ergotamine tartrate and caffeine TABLET, FILM COATED ORAL 20050916 ANDA ANDA040590 Mikart, Inc. ERGOTAMINE TARTRATE; CAFFEINE 1; 100 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 46672-280_ca5cd4ca-5017-4d02-9be3-2c5510165b2f 46672-280 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20091109 ANDA ANDA040851 Mikart, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 46672-281_ca5cd4ca-5017-4d02-9be3-2c5510165b2f 46672-281 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20091109 ANDA ANDA040851 Mikart, Inc. BENZONATATE 150 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 46672-282_ca5cd4ca-5017-4d02-9be3-2c5510165b2f 46672-282 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20091109 ANDA ANDA040851 Mikart, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 46672-286_9b0ff3d5-b0d9-49b9-9b46-7c3a12e4c358 46672-286 HUMAN PRESCRIPTION DRUG butalbital and acetaminophen butalbital and acetaminophen CAPSULE ORAL 20171227 ANDA ANDA207313 Mikart, Inc. BUTALBITAL; ACETAMINOPHEN 50; 300 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20191231 46672-561_5e954505-e8fa-d0be-e053-2991aa0ac161 46672-561 HUMAN PRESCRIPTION DRUG acetaminophen and codeine phosphate acetaminophen and codeine phosphate LIQUID ORAL 19921027 ANDA ANDA089450 Mikart, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 46672-597_0044ca87-ab7e-4955-a77f-e8fd665ce2ae 46672-597 HUMAN PRESCRIPTION DRUG isoniazid isoniazid SYRUP ORAL 19970721 ANDA ANDA081118 Mikart, Inc. ISONIAZID 50 mg/5mL Antimycobacterial [EPC] N 20181231 46672-606_999d4eb9-57ec-48b9-8d8b-0d5f842f05bc 46672-606 HUMAN PRESCRIPTION DRUG amantadine hydrochloride amantadine hydrochloride SYRUP ORAL 19930628 ANDA ANDA074028 Mikart, Inc. AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 46672-633_9d1d4604-7969-4383-98b5-13807acdccac 46672-633 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine SYRUP ORAL 20030131 ANDA ANDA040387 Mikart, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/15mL; mg/15mL; mg/15mL Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 46672-635_8b5d1f1c-5c95-428e-90fd-842b78338892 46672-635 HUMAN PRESCRIPTION DRUG trihexyphenidyl hydrochloride trihexyphenidyl hydrochloride SOLUTION ORAL 19991004 ANDA ANDA040251 Mikart, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/5mL N 20181231 46672-641_ff69c8c2-1490-45b4-a0b8-21a84fb66326 46672-641 HUMAN PRESCRIPTION DRUG ethosuximide ethosuximide SOLUTION ORAL 20031222 ANDA ANDA040506 Mikart, Inc. ETHOSUXIMIDE 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 46672-642_b551ecde-1413-4940-8398-e8b2c8663775 46672-642 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen SYRUP ORAL 20030925 ANDA ANDA040482 Mikart, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 46672-644_748c233b-6ab9-42d0-89ab-e7ead30f7947 46672-644 HUMAN PRESCRIPTION DRUG carbinoxamine maleate carbinoxamine maleate SYRUP ORAL 20030425 ANDA ANDA040458 Mikart, Inc. CARBINOXAMINE MALEATE 4 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 46672-645_917bac06-323a-4df7-aca1-978596dcc1eb 46672-645 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen SYRUP ORAL 20100225 ANDA ANDA040881 Mikart, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 46672-646_848b7c56-f9cc-4613-92fe-dd7965698f61 46672-646 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate SOLUTION ORAL 20080129 ANDA ANDA040776 Mikart, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 46672-657_3fdc101a-6deb-481f-ac50-de4aa9198142 46672-657 HUMAN PRESCRIPTION DRUG dicyclomine hydrochloride dicyclomine hydrochloride SOLUTION ORAL 20050324 ANDA ANDA040169 Mikart, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 46672-829_9c97d814-64b9-4ba2-a161-fec679fe9d0b 46672-829 HUMAN PRESCRIPTION DRUG meperidine hydrochloride meperidine hydrochloride TABLET ORAL 20090624 ANDA ANDA040893 Mikart, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46672-830_9c97d814-64b9-4ba2-a161-fec679fe9d0b 46672-830 HUMAN PRESCRIPTION DRUG meperidine hydrochloride meperidine hydrochloride TABLET ORAL 20090624 ANDA ANDA040893 Mikart, Inc. MEPERIDINE HYDROCHLORIDE 75 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46672-831_9c97d814-64b9-4ba2-a161-fec679fe9d0b 46672-831 HUMAN PRESCRIPTION DRUG meperidine hydrochloride meperidine hydrochloride TABLET ORAL 20090624 ANDA ANDA040893 Mikart, Inc. MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46672-832_9c97d814-64b9-4ba2-a161-fec679fe9d0b 46672-832 HUMAN PRESCRIPTION DRUG meperidine hydrochloride meperidine hydrochloride TABLET ORAL 20090624 ANDA ANDA040893 Mikart, Inc. MEPERIDINE HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46672-836_64573fa5-b568-4485-abb1-a6422e408470 46672-836 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate TABLET ORAL 20111025 ANDA ANDA090533 Mikart, Inc. DEXTROAMPHETAMINE SULFATE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 46672-837_64573fa5-b568-4485-abb1-a6422e408470 46672-837 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate TABLET ORAL 20111025 ANDA ANDA090533 Mikart, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 46672-838_64573fa5-b568-4485-abb1-a6422e408470 46672-838 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate TABLET ORAL 20111025 ANDA ANDA090533 Mikart, Inc. DEXTROAMPHETAMINE SULFATE 7.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 46672-839_64573fa5-b568-4485-abb1-a6422e408470 46672-839 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate TABLET ORAL 20111025 ANDA ANDA090533 Mikart, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 46672-840_64573fa5-b568-4485-abb1-a6422e408470 46672-840 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate TABLET ORAL 20111025 ANDA ANDA090533 Mikart, Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 46672-841_64573fa5-b568-4485-abb1-a6422e408470 46672-841 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate TABLET ORAL 20111025 ANDA ANDA090533 Mikart, Inc. DEXTROAMPHETAMINE SULFATE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 46672-842_64573fa5-b568-4485-abb1-a6422e408470 46672-842 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate TABLET ORAL 20111025 ANDA ANDA090533 Mikart, Inc. DEXTROAMPHETAMINE SULFATE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 46672-844_76c76f8e-d8e8-429a-ba67-c270e5ac6c83 46672-844 HUMAN PRESCRIPTION DRUG benzphetamine hydrochloride benzphetamine hydrochloride TABLET ORAL 20111101 ANDA ANDA090473 Mikart, Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 46672-851_cab4b768-da1f-4f27-93a0-4d2e40fd0a1b 46672-851 HUMAN PRESCRIPTION DRUG sodium phenylbutyrate sodium phenylbutyrate TABLET ORAL 20111118 ANDA ANDA090910 Mikart, Inc. SODIUM PHENYLBUTYRATE 500 mg/1 Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 46672-856_91257639-85a1-404d-bfb1-b63a3f4521e7 46672-856 HUMAN PRESCRIPTION DRUG butalbital and acetaminophen butalbital and acetaminophen TABLET ORAL 20161115 ANDA ANDA207386 Mikart, Inc. BUTALBITAL; ACETAMINOPHEN 50; 300 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 46672-857_5c90961f-36c4-4a50-8971-180b42ac6998 46672-857 HUMAN PRESCRIPTION DRUG carbinoxamine maleate carbinoxamine maleate TABLET ORAL 20160531 ANDA ANDA207484 Mikart, Inc. CARBINOXAMINE MALEATE 6 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 46672-860_25d76674-a1d6-4d01-a8e2-85cf0e86b672 46672-860 HUMAN PRESCRIPTION DRUG chlorzoxazone chlorzoxazone TABLET ORAL 20160624 ANDA ANDA207483 Mikart, Inc. CHLORZOXAZONE 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 46672-865_38b899c9-1f8b-4260-a9b3-df5f140ee1ba 46672-865 HUMAN PRESCRIPTION DRUG isoniazid isoniazid TABLET ORAL 19970626 ANDA ANDA040090 Mikart, Inc. ISONIAZID 100 mg/1 Antimycobacterial [EPC] N 20181231 46672-866_38b899c9-1f8b-4260-a9b3-df5f140ee1ba 46672-866 HUMAN PRESCRIPTION DRUG isoniazid isoniazid TABLET ORAL 19970626 ANDA ANDA040090 Mikart, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 46708-003_92f6ef1e-3256-45a7-a409-80dd85e95187 46708-003 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20160322 ANDA ANDA078894 Alembic Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-004_92f6ef1e-3256-45a7-a409-80dd85e95187 46708-004 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20160322 ANDA ANDA078894 Alembic Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-005_92f6ef1e-3256-45a7-a409-80dd85e95187 46708-005 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20160322 ANDA ANDA078894 Alembic Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-006_92f6ef1e-3256-45a7-a409-80dd85e95187 46708-006 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20160322 ANDA ANDA078894 Alembic Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-007_92f6ef1e-3256-45a7-a409-80dd85e95187 46708-007 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20160322 ANDA ANDA078894 Alembic Pharmaceuticals Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-019_a0891a32-105b-48bc-a246-5e179d2e7fa1 46708-019 HUMAN PRESCRIPTION DRUG MEPROBAMATE MEPROBAMATE TABLET ORAL 20130723 ANDA ANDA090122 Alembic Pharmaceuticals Limited MEPROBAMATE 200 mg/1 CIV N 20181231 46708-020_a0891a32-105b-48bc-a246-5e179d2e7fa1 46708-020 HUMAN PRESCRIPTION DRUG MEPROBAMATE MEPROBAMATE TABLET ORAL 20130723 ANDA ANDA090122 Alembic Pharmaceuticals Limited MEPROBAMATE 400 mg/1 CIV N 20181231 46708-021_d1b962f7-531b-40a6-98d7-f41074fc2bf6 46708-021 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100507 ANDA ANDA090222 Alembic Pharmaceuticals Limited METRONIDAZOLE 750 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 46708-025_31f3c720-1597-4d43-9296-33017b90b15f 46708-025 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20101101 ANDA ANDA090430 Alembic Pharmaceuticals Limited THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 46708-026_31f3c720-1597-4d43-9296-33017b90b15f 46708-026 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20101101 ANDA ANDA090430 Alembic Pharmaceuticals Limited THEOPHYLLINE ANHYDROUS 450 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 46708-030_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-030 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-031_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-031 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-032_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-032 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-033_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-033 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-034_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-034 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-035_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-035 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-036_9a25f575-09ab-4d32-b73e-5426f08c00c4 46708-036 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130912 ANDA ANDA090429 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-044_6e2cd953-88bf-4094-8ba8-2c9ba020f4d7 46708-044 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20150106 ANDA ANDA091367 Alembic Pharmaceuticals Limited VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-045_6e2cd953-88bf-4094-8ba8-2c9ba020f4d7 46708-045 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20150106 ANDA ANDA091367 Alembic Pharmaceuticals Limited VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-046_6e2cd953-88bf-4094-8ba8-2c9ba020f4d7 46708-046 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20150106 ANDA ANDA091367 Alembic Pharmaceuticals Limited VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-047_6e2cd953-88bf-4094-8ba8-2c9ba020f4d7 46708-047 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20150106 ANDA ANDA091367 Alembic Pharmaceuticals Limited VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-060_d23fe59a-2ad6-4885-a0d8-2239048f05a3 46708-060 HUMAN PRESCRIPTION DRUG CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL TABLET ORAL 20170621 ANDA ANDA209119 Alembic Pharmaceuticals Limited CANDESARTAN CILEXETIL 32 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-063_33e6a772-382d-45f5-9d45-966c07759367 46708-063 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120613 ANDA ANDA091689 Alembic Pharmaceuticals Limited RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 46708-064_33e6a772-382d-45f5-9d45-966c07759367 46708-064 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120613 ANDA ANDA091689 Alembic Pharmaceuticals Limited RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 46708-065_33e6a772-382d-45f5-9d45-966c07759367 46708-065 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120613 ANDA ANDA091689 Alembic Pharmaceuticals Limited RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 46708-066_33e6a772-382d-45f5-9d45-966c07759367 46708-066 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120613 ANDA ANDA091689 Alembic Pharmaceuticals Limited RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 46708-092_6ca3acff-fe7c-483a-a728-39e06c279dbb 46708-092 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride 5 mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130304 ANDA ANDA201724 Alembic Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 46708-093_6ca3acff-fe7c-483a-a728-39e06c279dbb 46708-093 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride 5 mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20130219 ANDA ANDA201724 Alembic Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 46708-095_ae6522d4-d824-44aa-afe0-70cdcbd845af 46708-095 HUMAN PRESCRIPTION DRUG lamotrigine lamotrigine chewable dispersible TABLET, FOR SUSPENSION ORAL 20160129 ANDA ANDA201168 Alembic Pharmaceuticals Limited LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 46708-096_ae6522d4-d824-44aa-afe0-70cdcbd845af 46708-096 HUMAN PRESCRIPTION DRUG lamotrigine lamotrigine chewable dispersible TABLET, FOR SUSPENSION ORAL 20160129 ANDA ANDA201168 Alembic Pharmaceuticals Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 46708-112_23c75a4d-b479-4f77-ae48-ce9750fa2e1e 46708-112 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20140314 ANDA ANDA202871 Alembic Pharmaceuticals Limited METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 46708-113_23c75a4d-b479-4f77-ae48-ce9750fa2e1e 46708-113 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20140314 ANDA ANDA202871 Alembic Pharmaceuticals Limited METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 46708-114_23c75a4d-b479-4f77-ae48-ce9750fa2e1e 46708-114 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20140314 ANDA ANDA202871 Alembic Pharmaceuticals Limited METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 46708-115_538ea34a-1ac3-48c8-b841-43be09285e12 46708-115 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 Alembic Pharmaceuticals Limited METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 46708-116_538ea34a-1ac3-48c8-b841-43be09285e12 46708-116 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 Alembic Pharmaceuticals Limited METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 46708-117_538ea34a-1ac3-48c8-b841-43be09285e12 46708-117 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20130917 ANDA ANDA202870 Alembic Pharmaceuticals Limited METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 100; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 46708-128_53df64fc-7fec-4c14-8fe3-c6a128be814a 46708-128 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride 20 mg Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140609 ANDA ANDA202949 Alembic Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-129_53df64fc-7fec-4c14-8fe3-c6a128be814a 46708-129 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride 30 mg Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140609 ANDA ANDA202949 Alembic Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-130_53df64fc-7fec-4c14-8fe3-c6a128be814a 46708-130 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride 60 mg Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140609 ANDA ANDA202949 Alembic Pharmaceuticals Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-131_6e49aa1c-de92-47a6-b0f5-8911caa93a92 46708-131 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA203012 Alembic Pharmaceuticals Limited OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-132_6e49aa1c-de92-47a6-b0f5-8911caa93a92 46708-132 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA203012 Alembic Pharmaceuticals Limited OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-133_6e49aa1c-de92-47a6-b0f5-8911caa93a92 46708-133 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA203012 Alembic Pharmaceuticals Limited OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-134_1dc7eb8e-abec-4906-9e02-c5b25f8c1b3d 46708-134 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20170221 ANDA ANDA203390 Alembic Pharmaceuticals Limited QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-135_1dc7eb8e-abec-4906-9e02-c5b25f8c1b3d 46708-135 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20170221 ANDA ANDA203390 Alembic Pharmaceuticals Limited QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-136_1dc7eb8e-abec-4906-9e02-c5b25f8c1b3d 46708-136 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20170221 ANDA ANDA203390 Alembic Pharmaceuticals Limited QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-137_1dc7eb8e-abec-4906-9e02-c5b25f8c1b3d 46708-137 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20170221 ANDA ANDA203390 Alembic Pharmaceuticals Limited QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-138_1dc7eb8e-abec-4906-9e02-c5b25f8c1b3d 46708-138 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20170221 ANDA ANDA203390 Alembic Pharmaceuticals Limited QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-139_1dc7eb8e-abec-4906-9e02-c5b25f8c1b3d 46708-139 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20170221 ANDA ANDA203390 Alembic Pharmaceuticals Limited QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-148_3e3e090f-864c-40db-a329-4f6088f38d30 46708-148 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20170221 ANDA ANDA204445 Alembic Pharmaceuticals Limited LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 46708-149_8c65d555-8db8-40d9-be30-309ef09f19be 46708-149 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET ORAL 20170424 ANDA ANDA204233 Alembic Pharmaceuticals Limited OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 46708-150_8c65d555-8db8-40d9-be30-309ef09f19be 46708-150 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET ORAL 20170424 ANDA ANDA204233 Alembic Pharmaceuticals Limited OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 46708-151_8c65d555-8db8-40d9-be30-309ef09f19be 46708-151 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET ORAL 20170424 ANDA ANDA204233 Alembic Pharmaceuticals Limited OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 46708-181_b8d657ac-dbda-4455-8bb5-3896951c3b67 46708-181 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20161201 ANDA ANDA205074 Alembic Pharmaceuticals Limited ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 46708-182_b8d657ac-dbda-4455-8bb5-3896951c3b67 46708-182 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20161201 ANDA ANDA205074 Alembic Pharmaceuticals Limited ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 46708-183_74f035ec-a0b1-4371-a17b-20b0b11864c9 46708-183 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20151222 ANDA ANDA205233 Alembic Pharmaceuticals Limited LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 46708-184_15b438b4-4874-43f4-a50a-4e6f3e5530ac 46708-184 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20161122 ANDA ANDA205234 Alembic Pharmaceuticals Limited TELMISARTAN; AMLODIPINE BESYLATE 40; 5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 46708-185_15b438b4-4874-43f4-a50a-4e6f3e5530ac 46708-185 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20161122 ANDA ANDA205234 Alembic Pharmaceuticals Limited TELMISARTAN; AMLODIPINE BESYLATE 40; 10 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 46708-186_15b438b4-4874-43f4-a50a-4e6f3e5530ac 46708-186 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20161122 ANDA ANDA205234 Alembic Pharmaceuticals Limited TELMISARTAN; AMLODIPINE BESYLATE 80; 5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 46708-187_15b438b4-4874-43f4-a50a-4e6f3e5530ac 46708-187 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20161122 ANDA ANDA205234 Alembic Pharmaceuticals Limited TELMISARTAN; AMLODIPINE BESYLATE 80; 10 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 46708-204_f9d8b5a7-435f-40e6-8596-5f2376b92c74 46708-204 HUMAN PRESCRIPTION DRUG ITRACONAZOLE itraconazole CAPSULE ORAL 20161216 ANDA ANDA206741 Alembic Pharmaceuticals Limited ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 46708-209_5b476740-e3f0-4f68-b07c-cd9eb2fa27ca 46708-209 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide 40 mg/12.5 mg Telmisartan and Hydrochlorothiazide TABLET ORAL 20140314 ANDA ANDA203010 Alembic Pharmaceuticals Limited TELMISARTAN; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 46708-210_5b476740-e3f0-4f68-b07c-cd9eb2fa27ca 46708-210 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide 80 mg/12.5 mg Telmisartan and Hydrochlorothiazide TABLET ORAL 20140314 ANDA ANDA203010 Alembic Pharmaceuticals Limited TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 46708-211_5b476740-e3f0-4f68-b07c-cd9eb2fa27ca 46708-211 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide 80 mg/25 mg Telmisartan and Hydrochlorothiazide TABLET ORAL 20140314 ANDA ANDA203010 Alembic Pharmaceuticals Limited TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 46708-212_cb2df7f7-fee8-42ba-8936-0788c4fcc0cb 46708-212 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Olmesartran medoxomil Amlodipine besylate and Olmesartran medoxomil TABLET, FILM COATED ORAL 20170718 ANDA ANDA207073 Alembic Pharmaceuticals Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-213_cb2df7f7-fee8-42ba-8936-0788c4fcc0cb 46708-213 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Olmesartran medoxomil Amlodipine besylate and Olmesartran medoxomil TABLET, FILM COATED ORAL 20170718 ANDA ANDA207073 Alembic Pharmaceuticals Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-214_cb2df7f7-fee8-42ba-8936-0788c4fcc0cb 46708-214 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Olmesartran medoxomil Amlodipine besylate and Olmesartran medoxomil TABLET, FILM COATED ORAL 20170718 ANDA ANDA207073 Alembic Pharmaceuticals Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-215_cb2df7f7-fee8-42ba-8936-0788c4fcc0cb 46708-215 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Olmesartran medoxomil Amlodipine besylate and Olmesartran medoxomil TABLET, FILM COATED ORAL 20170718 ANDA ANDA207073 Alembic Pharmaceuticals Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-223_da7c2732-232c-4e71-92d9-577ef8617f56 46708-223 HUMAN PRESCRIPTION DRUG DARIFENACIN DARIFENACIN TABLET, EXTENDED RELEASE ORAL 20171212 ANDA ANDA207681 Alembic Pharmaceuticals Limited DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 46708-224_da7c2732-232c-4e71-92d9-577ef8617f56 46708-224 HUMAN PRESCRIPTION DRUG DARIFENACIN DARIFENACIN TABLET, EXTENDED RELEASE ORAL 20171212 ANDA ANDA207681 Alembic Pharmaceuticals Limited DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 46708-242_e24239fa-b929-43ef-a034-b18cb7c51b53 46708-242 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride TABLET, FILM COATED ORAL 20170415 ANDA ANDA208698 Alembic Pharmaceuticals Limited FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-243_e24239fa-b929-43ef-a034-b18cb7c51b53 46708-243 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride TABLET, FILM COATED ORAL 20170415 ANDA ANDA208698 Alembic Pharmaceuticals Limited FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-244_c880d43a-fa8c-4f7a-a488-419bae7cc311 46708-244 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20170515 ANDA ANDA208705 Alembic Pharmaceuticals Limited FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 46708-245_c880d43a-fa8c-4f7a-a488-419bae7cc311 46708-245 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20170518 ANDA ANDA208705 Alembic Pharmaceuticals Limited FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 46708-246_d8887814-3e56-447e-8bc3-add1861e0cf7 46708-246 HUMAN PRESCRIPTION DRUG amantadine amantadine CAPSULE ORAL 20170622 ANDA ANDA208966 Alembic Pharmaceuticals Limited AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 46708-249_254b8d32-2b6e-4894-8127-04e01c36c8f6 46708-249 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20170731 ANDA ANDA209165 Alembic Pharmaceuticals Limited DOXYCYCLINE 75 mg/1 N 20181231 46708-250_254b8d32-2b6e-4894-8127-04e01c36c8f6 46708-250 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20170731 ANDA ANDA209165 Alembic Pharmaceuticals Limited DOXYCYCLINE 100 mg/1 N 20181231 46708-251_9e3d0c09-a4b7-4735-835f-317ace43078d 46708-251 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine Succinate TABLET, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204003 Alembic Pharmaceuticals Limited DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 46708-252_9e3d0c09-a4b7-4735-835f-317ace43078d 46708-252 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine Succinate TABLET, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204003 Alembic Pharmaceuticals Limited DESVENLAFAXINE SUCCINATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 46708-254_793fc904-2f11-4f97-a0ac-4d6910cac0f9 46708-254 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Alembic Pharmaceuticals Limited ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-255_793fc904-2f11-4f97-a0ac-4d6910cac0f9 46708-255 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Alembic Pharmaceuticals Limited ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-256_793fc904-2f11-4f97-a0ac-4d6910cac0f9 46708-256 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Alembic Pharmaceuticals Limited ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-257_793fc904-2f11-4f97-a0ac-4d6910cac0f9 46708-257 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Alembic Pharmaceuticals Limited ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-258_793fc904-2f11-4f97-a0ac-4d6910cac0f9 46708-258 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Alembic Pharmaceuticals Limited ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-259_793fc904-2f11-4f97-a0ac-4d6910cac0f9 46708-259 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Alembic Pharmaceuticals Limited ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-260_4f1691a8-724e-430d-9bab-27b59ef9bd4e 46708-260 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET, ORALLY DISINTEGRATING ORAL 20150521 ANDA ANDA202102 Alembic Pharmaceuticals Limited ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-261_4f1691a8-724e-430d-9bab-27b59ef9bd4e 46708-261 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET, ORALLY DISINTEGRATING ORAL 20150521 ANDA ANDA202102 Alembic Pharmaceuticals Limited ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 46708-262_2e01dbdd-f439-45d7-9085-2d92a1a1fee2 46708-262 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130314 ANDA ANDA202786 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-263_2e01dbdd-f439-45d7-9085-2d92a1a1fee2 46708-263 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130314 ANDA ANDA202786 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-264_2e01dbdd-f439-45d7-9085-2d92a1a1fee2 46708-264 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130314 ANDA ANDA202786 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-265_2e01dbdd-f439-45d7-9085-2d92a1a1fee2 46708-265 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130314 ANDA ANDA202786 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-266_2e01dbdd-f439-45d7-9085-2d92a1a1fee2 46708-266 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130314 ANDA ANDA202786 Alembic Pharmaceuticals Limited ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 46708-267_14e8d788-e44c-4a40-8678-25cf45fed477 46708-267 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150822 ANDA ANDA204519 Alembic Pharmaceuticals Limited CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 46708-268_14e8d788-e44c-4a40-8678-25cf45fed477 46708-268 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150822 ANDA ANDA204519 Alembic Pharmaceuticals Limited CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 46708-269_14e8d788-e44c-4a40-8678-25cf45fed477 46708-269 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150822 ANDA ANDA204519 Alembic Pharmaceuticals Limited CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 46708-270_14e8d788-e44c-4a40-8678-25cf45fed477 46708-270 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150822 ANDA ANDA204519 Alembic Pharmaceuticals Limited CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 46708-271_7c8f445c-19a5-4643-898c-06a657977b06 46708-271 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20090701 ANDA ANDA090223 Alembic Pharmaceuticals Limited FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-272_7c8f445c-19a5-4643-898c-06a657977b06 46708-272 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20090701 ANDA ANDA090223 Alembic Pharmaceuticals Limited FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-273_7c8f445c-19a5-4643-898c-06a657977b06 46708-273 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20090701 ANDA ANDA090223 Alembic Pharmaceuticals Limited FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-274_be0e2f13-1aa5-44c2-b883-c250de496e9f 46708-274 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130101 ANDA ANDA090607 Alembic Pharmaceuticals Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 46708-275_be0e2f13-1aa5-44c2-b883-c250de496e9f 46708-275 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130101 ANDA ANDA090607 Alembic Pharmaceuticals Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 46708-276_be0e2f13-1aa5-44c2-b883-c250de496e9f 46708-276 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130101 ANDA ANDA090607 Alembic Pharmaceuticals Limited LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 46708-277_be0e2f13-1aa5-44c2-b883-c250de496e9f 46708-277 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130101 ANDA ANDA090607 Alembic Pharmaceuticals Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 46708-293_7c0f3fa5-0a44-4a98-bc43-8bff8e95c462 46708-293 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 Alembic Pharmaceuticals Limited FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 46708-294_7c0f3fa5-0a44-4a98-bc43-8bff8e95c462 46708-294 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 Alembic Pharmaceuticals Limited FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 46708-295_bc570682-413b-46fb-a069-c2986884bfce 46708-295 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20160129 ANDA ANDA201724 Alembic Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 46708-296_bc570682-413b-46fb-a069-c2986884bfce 46708-296 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20160129 ANDA ANDA201724 Alembic Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 46708-306_88adde35-f633-478c-8b5f-35aad9564be2 46708-306 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20160503 ANDA ANDA091368 Alembic Pharmaceuticals Limited CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 46708-307_88adde35-f633-478c-8b5f-35aad9564be2 46708-307 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20160503 ANDA ANDA091368 Alembic Pharmaceuticals Limited CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 46708-308_88adde35-f633-478c-8b5f-35aad9564be2 46708-308 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20160503 ANDA ANDA091368 Alembic Pharmaceuticals Limited CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 46708-385_5b8496fe-b647-4ce6-aeef-71245712e46f 46708-385 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20170630 ANDA ANDA202700 Alembic Pharmaceuticals Limited MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] N 20181231 46708-386_5b8496fe-b647-4ce6-aeef-71245712e46f 46708-386 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20170630 ANDA ANDA202700 Alembic Pharmaceuticals Limited MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] N 20181231 46708-428_d7455566-16aa-488a-af2a-93b55a04c02f 46708-428 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20161201 ANDA ANDA079067 Alembic Pharmaceuticals Limited METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 46708-429_d7455566-16aa-488a-af2a-93b55a04c02f 46708-429 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20161201 ANDA ANDA079067 Alembic Pharmaceuticals Limited METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 46708-430_b73da6e2-1494-436f-a204-2e4e4c5974b6 46708-430 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Alembic Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-431_b73da6e2-1494-436f-a204-2e4e4c5974b6 46708-431 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Alembic Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-432_b73da6e2-1494-436f-a204-2e4e4c5974b6 46708-432 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Alembic Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-433_b73da6e2-1494-436f-a204-2e4e4c5974b6 46708-433 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Alembic Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-434_b73da6e2-1494-436f-a204-2e4e4c5974b6 46708-434 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Alembic Pharmaceuticals Limited VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 46708-435_387053e5-7eda-4282-b58a-5789430a2e99 46708-435 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole CAPSULE ORAL 20161209 ANDA ANDA079065 Alembic Pharmaceuticals Limited METRONIDAZOLE 375 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 46708-436_f6a4107e-b393-45ed-8e5a-70af5bd53826 46708-436 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20161201 ANDA ANDA091369 Alembic Pharmaceuticals Limited LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] N 20181231 46708-437_f6a4107e-b393-45ed-8e5a-70af5bd53826 46708-437 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20161201 ANDA ANDA091369 Alembic Pharmaceuticals Limited LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] N 20181231 46708-438_34703033-14c4-459c-8b8f-2f2e1145aff7 46708-438 HUMAN PRESCRIPTION DRUG hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20170302 ANDA ANDA200645 Alembic Pharmaceuticals Limited HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 46708-439_0898f423-0aa9-409c-8d4e-1349b59141d1 46708-439 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET ORAL 20160701 ANDA ANDA091236 Alembic Pharmaceuticals Limited IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-440_0898f423-0aa9-409c-8d4e-1349b59141d1 46708-440 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET ORAL 20160701 ANDA ANDA091236 Alembic Pharmaceuticals Limited IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-441_0898f423-0aa9-409c-8d4e-1349b59141d1 46708-441 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET ORAL 20160701 ANDA ANDA091236 Alembic Pharmaceuticals Limited IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-442_9492a1cd-c012-4b43-931d-235220065e1e 46708-442 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20160523 ANDA ANDA091370 Alembic Pharmaceuticals Limited IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 46708-443_9492a1cd-c012-4b43-931d-235220065e1e 46708-443 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20160523 ANDA ANDA091370 Alembic Pharmaceuticals Limited IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 46708-444_9492a1cd-c012-4b43-931d-235220065e1e 46708-444 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20161017 ANDA ANDA091370 Alembic Pharmaceuticals Limited IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 46708-445_eeb77c84-38d3-432d-914a-54b312b374bd 46708-445 HUMAN PRESCRIPTION DRUG Losatan Potassium Losatan Potassium TABLET, FILM COATED ORAL 20160523 ANDA ANDA090428 Alembic Pharmaceuticals Limited LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-446_eeb77c84-38d3-432d-914a-54b312b374bd 46708-446 HUMAN PRESCRIPTION DRUG Losatan Potassium Losatan Potassium TABLET, FILM COATED ORAL 20160523 ANDA ANDA090428 Alembic Pharmaceuticals Limited LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-447_eeb77c84-38d3-432d-914a-54b312b374bd 46708-447 HUMAN PRESCRIPTION DRUG Losatan Potassium Losatan Potassium TABLET, FILM COATED ORAL 20160523 ANDA ANDA090428 Alembic Pharmaceuticals Limited LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 46708-448_bbf7e20d-dfc2-4115-8788-c0cac15a1148 46708-448 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160523 ANDA ANDA091617 Alembic Pharmaceuticals Limited LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 46708-449_bbf7e20d-dfc2-4115-8788-c0cac15a1148 46708-449 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160523 ANDA ANDA091617 Alembic Pharmaceuticals Limited LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 46708-450_bbf7e20d-dfc2-4115-8788-c0cac15a1148 46708-450 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160523 ANDA ANDA091617 Alembic Pharmaceuticals Limited LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 46708-451_b86c0f6e-480b-40e7-aa4d-21bd0659101d 46708-451 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine hydrochloride TABLET, COATED ORAL 20151013 ANDA ANDA200891 Alembic Pharmaceuticals Limited MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 46708-452_b86c0f6e-480b-40e7-aa4d-21bd0659101d 46708-452 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine hydrochloride TABLET, COATED ORAL 20151013 ANDA ANDA200891 Alembic Pharmaceuticals Limited MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 46708-453_3b80f726-9e1e-4d44-ad4f-afd10e26292f 46708-453 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160520 ANDA ANDA201662 Alembic Pharmaceuticals Limited VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 46708-454_3b80f726-9e1e-4d44-ad4f-afd10e26292f 46708-454 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160520 ANDA ANDA201662 Alembic Pharmaceuticals Limited VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 46708-455_3b80f726-9e1e-4d44-ad4f-afd10e26292f 46708-455 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160520 ANDA ANDA201662 Alembic Pharmaceuticals Limited VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 46708-456_3b80f726-9e1e-4d44-ad4f-afd10e26292f 46708-456 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160520 ANDA ANDA201662 Alembic Pharmaceuticals Limited VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 46708-457_3b80f726-9e1e-4d44-ad4f-afd10e26292f 46708-457 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160520 ANDA ANDA201662 Alembic Pharmaceuticals Limited VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 46708-458_a9c442dc-749e-4de0-bca3-1044eb78da72 46708-458 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET, FILM COATED ORAL 20161201 ANDA ANDA202713 Alembic Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 46708-459_a9c442dc-749e-4de0-bca3-1044eb78da72 46708-459 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET, FILM COATED ORAL 20161201 ANDA ANDA202713 Alembic Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 46708-460_a9c442dc-749e-4de0-bca3-1044eb78da72 46708-460 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET, FILM COATED ORAL 20161201 ANDA ANDA202713 Alembic Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 46708-461_a9c442dc-749e-4de0-bca3-1044eb78da72 46708-461 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET, FILM COATED ORAL 20161201 ANDA ANDA202713 Alembic Pharmaceuticals Limited AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 46708-462_75a92ce1-eade-4b71-80ab-d7fd1f57e352 46708-462 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20160104 ANDA ANDA204232 Alembic Pharmaceuticals Limited ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 46708-463_75a92ce1-eade-4b71-80ab-d7fd1f57e352 46708-463 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20160104 ANDA ANDA204232 Alembic Pharmaceuticals Limited ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 46783-121_5713eeed-db88-4e10-8ef1-baca3ca8c8ed 46783-121 HUMAN PRESCRIPTION DRUG Asclera POLIDOCANOL INJECTION, SOLUTION INTRAVENOUS 20100601 NDA NDA021201 Merz North America, Inc POLIDOCANOL .005 g/mL Sclerosing Agent [EPC],Sclerosing Activity [MoA],Vascular Sclerosing Activity [PE] N 20181231 46783-160_3b6e7a92-3a21-4551-bb21-6374328508e5 46783-160 HUMAN PRESCRIPTION DRUG Xeomin incobotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20110801 BLA BLA125360 Merz North America, Inc. BOTULINUM TOXIN TYPE A 100 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 46783-161_3b6e7a92-3a21-4551-bb21-6374328508e5 46783-161 HUMAN PRESCRIPTION DRUG Xeomin incobotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20110801 BLA BLA125360 Merz North America, Inc. BOTULINUM TOXIN TYPE A 50 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 46783-165_3b6e7a92-3a21-4551-bb21-6374328508e5 46783-165 HUMAN PRESCRIPTION DRUG Xeomin incobotulinumtoxinA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20110801 BLA BLA125360 Merz North America, Inc. BOTULINUM TOXIN TYPE A 50 [USP'U]/1 Acetylcholine Release Inhibitor [EPC],Acetylcholine Release Inhibitors [MoA] N 20181231 46783-175_7b2ebf7b-6181-41bc-9b3c-540c44838bb4 46783-175 HUMAN OTC DRUG Journee Riche Bio-restorative Day Balm Broad-spectrum Sunscreen SPF 30 OCTINOXATE and ZINC OXIDE LOTION TOPICAL 20150518 OTC MONOGRAPH FINAL part352 Merz North America, Inc. OCTINOXATE; ZINC OXIDE 7.5; 7.3 mg/100mL; mg/100mL E 20171231 46783-221_5713eeed-db88-4e10-8ef1-baca3ca8c8ed 46783-221 HUMAN PRESCRIPTION DRUG Asclera POLIDOCANOL INJECTION, SOLUTION INTRAVENOUS 20100601 NDA NDA021201 Merz North America, Inc POLIDOCANOL .01 g/mL Sclerosing Agent [EPC],Sclerosing Activity [MoA],Vascular Sclerosing Activity [PE] N 20181231 46823-001_b63c7831-9543-42ed-9991-79bd796a543a 46823-001 HUMAN OTC DRUG Eye Drops Glycerin SOLUTION OPHTHALMIC 20170306 OTC MONOGRAPH FINAL part346 Opto-Pharm Pte Ltd GLYCERIN 1 g/100g N 20191231 46911-001_4abb85a2-6520-41f1-b55b-96da09225a5b 46911-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS H & C Oxygen, Inc. OXYGEN 99 L/100L E 20171231 46987-322_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-322 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46987-323_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-323 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46987-324_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-324 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46987-325_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-325 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46987-326_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-326 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46987-327_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-327 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120507 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46987-328_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-328 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120507 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 70 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46987-329_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-329 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120507 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 130 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46987-330_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-330 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120507 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46987-377_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-377 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46987-410_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-410 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46987-412_b3a7cdbc-53b9-43e8-a7d1-949bac38350c 46987-412 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Kadian LLC MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 46994-069_accb9b31-3c20-4884-9665-c244781a6b6f 46994-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20141108 OTC MONOGRAPH FINAL part347 Save-A-Lot Food Stores, LTD PETROLATUM 1 g/g N 20181231 46994-072_d0db7c6e-b754-40db-947b-8a82e9e75953 46994-072 HUMAN OTC DRUG Being Well Antiseptic Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20141003 OTC MONOGRAPH NOT FINAL part356 Save-A-Lot Food Stores, LTD EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 46994-150_80628c43-32ef-4813-a659-1d3e2c0d9abd 46994-150 HUMAN OTC DRUG being well night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20150914 OTC MONOGRAPH FINAL part341 Save-A-Lot Food Stores Ltd ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 46994-157_4f6adc0d-4719-4e35-8210-07c1519b0d89 46994-157 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 SAVE-A-LOT FOOD STORES, LTD. ASPIRIN 325 mg/1 N 20181231 46994-175_ee3c42af-cf5f-45ed-879c-b71a459854f1 46994-175 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 SAVE-A-LOT FOOD STORES, LTD. ACETAMINOPHEN 500 mg/1 N 20181231 46994-291_04d1f730-225f-484c-9d74-87be76827d38 46994-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 SAVE-A-LOT FOOD STORES, LTD. IBUPROFEN 200 mg/1 N 20181231 46994-302_7e1bbaa4-f156-418b-8639-36b0cadce3e9 46994-302 HUMAN OTC DRUG Being Well stomach relief original strength Bismuth subsalicylate SUSPENSION ORAL 20060225 OTC MONOGRAPH FINAL part335 Save-A-Lot Food Stores Ltd BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 46994-304_cb9dc37d-3c9d-4594-a9a5-62954abf497b 46994-304 HUMAN OTC DRUG being well nasal 12 hour oxymetazoline hydrochloride SPRAY NASAL 20060225 OTC MONOGRAPH FINAL part341 Save-A-Lot Food Stores Ltd OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 46994-327_b9fb74bf-0a7b-4ef4-8302-599300fe13d7 46994-327 HUMAN OTC DRUG Laxative Gentle Bisacodyl TABLET, SUGAR COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 SAVE-A-LOT FOOD STORES, LTD. BISACODYL 5 mg/1 N 20181231 46994-329_cfbd7d22-f8d2-46da-bbec-1e7055dcc580 46994-329 HUMAN OTC DRUG Complete Allergy Medicine Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 SAVE-A-LOT FOOD STORES, LTD. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 46994-359_f2083b51-4e4f-4233-9a63-182ae74b0225 46994-359 HUMAN OTC DRUG Being Well Adult Cough Relief DM Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20060225 OTC MONOGRAPH FINAL part341 Save-A-Lot Food Stores Ltd DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 46994-368_93628cfd-ac93-42ce-8364-7db172e8a209 46994-368 HUMAN OTC DRUG Being Well all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20060225 ANDA ANDA074661 Save-A-Lot Food Stores Ltd NAPROXEN SODIUM 220 mg/1 N 20181231 46994-370_6fbb41d1-34db-4732-96ac-ee9175ad8109 46994-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20151122 OTC MONOGRAPH NOT FINAL part333A Save-A-Lot Food Stores, LTD ALCOHOL 70 mL/100mL N 20181231 46994-453_0067fb38-20cc-4ff5-97d5-33c53ac639a2 46994-453 HUMAN OTC DRUG Nasal Decongestant Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 SAVE-A-LOT FOOD STORES, LTD. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 46994-458_5a1a8cf6-d97c-422e-8483-3215d08621d2 46994-458 HUMAN OTC DRUG being well allergy Cetirizine Hydrochloride TABLET ORAL 20080519 ANDA ANDA078336 Save-A-Lot Food Stores Ltd CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 46994-489_3e150ad7-bf98-444e-a575-4d6731e22530 46994-489 HUMAN OTC DRUG being well antacid Calcium carbonate TABLET, CHEWABLE ORAL 20100901 OTC MONOGRAPH FINAL part331 Save-A-Lot Food Stores Ltd CALCIUM CARBONATE 750 mg/1 N 20181231 46994-500_6566ae73-8322-4254-85cb-a1bcdf46dbab 46994-500 HUMAN OTC DRUG Being Well Body Daily Moisturizing dimethicone LOTION TOPICAL 20130301 OTC MONOGRAPH FINAL part347 Save-A-Lot Food Stores Ltd DIMETHICONE 1.25 g/100mL E 20171231 46994-503_aafd36f5-d305-457d-b377-378b7600f1e2 46994-503 HUMAN OTC DRUG Hand Sanitizer with Moisturizers and Vitamin E Alcohol GEL TOPICAL 20131125 OTC MONOGRAPH NOT FINAL part333A Save-A-Lot Food Stores Ltd ALCOHOL 70 g/100mL E 20171231 46994-505_bcc9bb94-2a8a-4309-8caf-7e9dd1cff1ae 46994-505 HUMAN OTC DRUG Being Well Body White Petrolatum OINTMENT TOPICAL 20130301 OTC MONOGRAPH FINAL part347 Save-A-Lot Food Stores Ltd PETROLATUM 1 g/g N 20181231 46994-510_5ac4701d-89dd-4bc8-85a8-66d66ed8b146 46994-510 HUMAN OTC DRUG BEING WELL BODY 2in1 Dandruff and Conditioner pyrithione zinc SHAMPOO TOPICAL 20130325 OTC MONOGRAPH FINAL part358H Save-A-Lot Food Stores Ltd PYRITHIONE ZINC 1 g/100mL E 20171231 46994-511_7e2ed247-5bec-4fce-9464-2926aaad6f81 46994-511 HUMAN OTC DRUG BEING WELL BODY Dry Scalp Care pyrithione zinc SHAMPOO TOPICAL 20130325 OTC MONOGRAPH FINAL part358H Save-A-Lot Food Stores Ltd PYRITHIONE ZINC 1 g/100mL E 20171231 46994-568_e77d69a2-d428-43ad-b6e5-f2d66b2f8152 46994-568 HUMAN OTC DRUG Ultra Dish chloroxylenol 0.30% LIQUID TOPICAL 20160711 OTC MONOGRAPH NOT FINAL part333A Save A Lot CHLOROXYLENOL 3.06 mg/mL N 20181231 46994-600_7867f9dc-272b-4b14-8414-bb681c1f4ade 46994-600 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 SAVE-A-LOT FOOD STORES, LTD. ASPIRIN 81 mg/1 N 20181231 46994-612_6ca7ebc4-d61a-4374-b6db-75c9c394bd5d 46994-612 HUMAN OTC DRUG Being Well Allergy Relief Loratadine TABLET ORAL 20060225 ANDA ANDA076301 Save-A-Lot Food Stores Ltd LORATADINE 10 mg/1 N 20181231 46994-619_29025e0e-6ee4-4e95-af11-f6e46a4b44c7 46994-619 HUMAN OTC DRUG Oatmeal Dimethicone LOTION TOPICAL 20151120 OTC MONOGRAPH FINAL part347 Save A Lot Food Stores LTD DIMETHICONE 13 mg/mL N 20181231 46994-664_e2aa8aeb-3dfa-4443-b10e-0f023c2f21b2 46994-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20100617 OTC MONOGRAPH NOT FINAL part356 Save A Lot Food Stores LTD EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 46994-810_879582db-4cc7-4074-be85-f695c746ef70 46994-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20160214 OTC MONOGRAPH NOT FINAL part333A Save-A-Lot Food Stores, LTD ISOPROPYL ALCOHOL 500 mg/mL N 20181231 46994-851_6888c636-4dc7-4236-8dcf-f00e680fc735 46994-851 HUMAN OTC DRUG Being Well Extra Strength Menthol Heat Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 SAVE-A-LOT FOOD STORES, LTD. MENTHOL 750 mg/1 N 20181231 46994-852_0c4530e1-3e39-4e52-af94-8ab274d4ce80 46994-852 HUMAN OTC DRUG Being Well Heartburn Relief Ranitidine TABLET, FILM COATED ORAL 20130909 ANDA ANDA091429 Save-A-Lot Food Stores Ltd RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 46994-871_14032f31-2c2b-4ea4-88f8-74f56725a3e0 46994-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Save A Lot Food Stores LTD HYDROGEN PEROXIDE 30 mg/mL N 20181231 46994-897_658307dc-4acc-446f-a594-dc24332436b4 46994-897 HUMAN OTC DRUG being well ibuprofen Ibuprofen SUSPENSION ORAL 20060225 ANDA ANDA074937 Save-A-Lot Food Stores Ltd IBUPROFEN 100 mg/5mL N 20181231 46994-915_2c416eed-4ced-4265-8e33-64b4d1b34e41 46994-915 HUMAN OTC DRUG being well omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080320 NDA NDA022032 Save-A-Lot Food Stores Ltd OMEPRAZOLE 20 mg/1 N 20181231 46994-935_af343b2d-e34e-4b60-8b9e-5b9ea7b9df9a 46994-935 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 SAVE-A-LOT FOOD STORES, LTD. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 47066-402_37d4cc31-7bb1-4d5c-b8b1-832d1a569d2f 47066-402 HUMAN OTC DRUG Foam Safe Povidone Iodine LIQUID TOPICAL 20120401 OTC MONOGRAPH FINAL part333C Gremed Manufacturing LLC POVIDONE-IODINE 7.5 mg/100mL E 20171231 47124-055_3f2356fa-1bad-4f1d-9b90-c4c605d20648 47124-055 HUMAN OTC DRUG Wegmans Aloe and Vitamin E Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Wegmans Food Markets Inc. BENZALKONIUM CHLORIDE .115 g/1 N 20181231 47124-111_b65a586a-25e4-408a-ab40-23a22d8e454d 47124-111 HUMAN OTC DRUG Body Mist SPF 55 Wegman Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0% SPRAY TOPICAL 20130306 OTC MONOGRAPH NOT FINAL part352 Wegman AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 10 g/100g; g/100g; g/100g; g/100g N 20191231 47124-177_995617c9-bd5c-45dd-ba16-5c89da6f9261 47124-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .46 mL/100mL N 20181231 47124-221_abe318f4-bfd3-4a5c-8766-b775af713351 47124-221 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .15 mL/100mL N 20181231 47124-232_f0b858f5-66f0-4e7b-8dde-f01c96c5e4d9 47124-232 HUMAN OTC DRUG Wegmans Antibacterial Cucumber Melon TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Wegman Food Markets Inc TRICLOSAN .115 mL/100mL N 20181231 47124-294_d28f4581-7a35-453a-910c-1f74b4bb778d 47124-294 HUMAN OTC DRUG WEGMANS ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC. TRICLOSAN .15 mL/100mL N 20181231 47124-295_db69b3b2-1538-4fd9-8885-68c200f48455 47124-295 HUMAN OTC DRUG ANTIBACTERIAL CUCUMBER MELON TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .115 mL/100mL N 20181231 47124-295_fd2883b4-ffe7-41d8-9c33-7b8bc1ce4ebd 47124-295 HUMAN OTC DRUG ANTIBACTERIAL CUCUMBER MELON TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .115 mL/100mL N 20181231 47124-299_b7ee97b6-07b2-4753-91c7-971b9417c640 47124-299 HUMAN OTC DRUG WEGMANS TRICLOSAN LIQUID TOPICAL 20130328 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC. TRICLOSAN 1.5 mg/mL N 20181231 47124-326_fdcc7080-75b4-4d8e-8423-57dcb3684d47 47124-326 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20140203 OTC MONOGRAPH NOT FINAL part356 Wegmans Food Markets EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 47124-333_5b38aaf3-d2c9-4aa7-b0de-f9fec027dd48 47124-333 HUMAN OTC DRUG Sheer Sunscreen SPF 50 Wegmans Homosalate - 6.00% Octinoxate - 7.50% Octisalate - 5.00% Octocrylene - 10.00% Zinc Oxide - 8.00% STICK TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Wegman HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 6; 7.5; 5; 10; 8 g/100g; g/100g; g/100g; g/100g; g/100g N 20191231 47124-406_5c5de2a4-aa7e-4cdd-b180-dcfc35268f11 47124-406 HUMAN OTC DRUG WEGMANS HAND SANITIZER THAI BAMBOO ETHYL ALCOHOL LIQUID TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC ALCOHOL 650 mg/mL N 20181231 47124-406_da114cbc-3a64-4a47-80e7-f07f7765f558 47124-406 HUMAN OTC DRUG WEGMANS HAND SANITIZER THAI BAMBOO ETHYL ALCOHOL LIQUID TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC ALCOHOL 650 mg/mL N 20181231 47124-407_9e7985a1-8468-4613-8286-8c37e954b48d 47124-407 HUMAN OTC DRUG WEGMANS HAND SANITIZER LYCHEE BERRY ETHYL ALCOHOL LIQUID TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC ALCOHOL 650 mg/mL N 20181231 47124-407_bea125cf-63ba-44e6-b237-3498e7d08d79 47124-407 HUMAN OTC DRUG Wegmans Hand Sanitizer Lychee Berry Ethyl Alcohol LIQUID TOPICAL 20170522 OTC MONOGRAPH NOT FINAL part333E Wegmans Food Markets Inc ALCOHOL 650 mg/mL N 20181231 47124-407_fe65bf77-7b42-4a5f-8101-a8509bf3703b 47124-407 HUMAN OTC DRUG WEGMANS HAND SANITIZER LYCHEE BERRY ETHYL ALCOHOL LIQUID TOPICAL 20141116 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC ALCOHOL 650 mg/mL N 20181231 47124-434_82963802-cd9d-4704-b6f7-99324e55b2f1 47124-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20131122 OTC MONOGRAPH NOT FINAL part356 Wegmans Food Markets, inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 47124-445_625c20c3-01f7-0a5e-e053-2a91aa0a5da1 47124-445 HUMAN OTC DRUG Sport Sunscreen SPF 30 Wegmans Avobenzone - 3.0% Homosalate - 15.0% Octisalate - 5.0% Octocrylene - 7.0% LOTION TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Wegman AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 47124-446_464e64e7-e11a-4a4b-9448-12a50c19e5b3 47124-446 HUMAN OTC DRUG Sport Sunscreen SPF 30 Wegmans Avobenzone - 3.0% Homosalate - 15.0% Octisalate - 5.0% Octocrylene - 8.0% SPRAY TOPICAL 20130203 OTC MONOGRAPH NOT FINAL part352 Wegman AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 8 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 47124-447_625d2334-3e40-11e4-e053-2a91aa0a5560 47124-447 HUMAN OTC DRUG Sheer Sunscreen SPF 30 Wegmans Avobenzone 2.00% Homosalate 15.00% Octinoxate 7.50% Octisalate 5.00% STICK TOPICAL 20130203 OTC MONOGRAPH NOT FINAL part352 Wegman AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 2; 15; 7.5; 5 g/100g; g/100g; g/100g; g/100g N 20191231 47124-449_63476067-ed5b-40d4-b7ca-6270e599a99d 47124-449 HUMAN OTC DRUG Sport Sunscreen SPF 50 Wegmans Homosalate - 6.00% Octinoxate - 7.50% Octisalate - 5.00% Octocrylene - 10.00% Zinc Oxide - 8.00% STICK TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Wegman HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 6; 5; 5; 10; 8 g/100g; g/100g; g/100g; g/100g; g/100g N 20191231 47124-450_dfbb18bd-6be6-4cbd-8f7b-258741b59437 47124-450 HUMAN OTC DRUG Sunscreen SPF 30 Wegmans Avobenzone - 3.0% Homosalate - 10.0% Octisalate - 5.0% Octocrylene - 10.0% LOTION TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Wegman AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 47124-451_a14cbd90-d6d3-4ae3-8235-c9bee807dd16 47124-451 HUMAN OTC DRUG Clear SPF 30 Face Sunscreen Wegmans Avobenzone - 3.0% Homosalate - 12.0% Octisalate - 5.0% Octocrylene - 3.0% LIQUID TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Wegman AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 12; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 47124-720_02b942cf-698e-4199-9529-27cd1292c6fe 47124-720 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .115 mL/100mL N 20181231 47124-720_1fa5a00a-38a4-4ba9-8caf-364bb0afba80 47124-720 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .115 mL/100mL N 20181231 47124-720_cda6d730-3dea-4651-be6f-928445afa574 47124-720 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC TRICLOSAN .115 mL/100mL N 20181231 47124-721_46388d66-3209-4651-ae23-161cd2a0a8bd 47124-721 HUMAN OTC DRUG WEGMANS ANTIBACTERIAL WITH MOISTURIZERS TRICLOSAN LIQUID TOPICAL 20130328 OTC MONOGRAPH NOT FINAL part333E WEGMANS FOOD MARKETS INC. TRICLOSAN 1.15 mg/mL N 20181231 47133-574_7b66b195-fd76-4dba-9f8b-74e9013180bd 47133-574 HUMAN PRESCRIPTION DRUG Elepsia XR Levetiracetam TABLET, EXTENDED RELEASE ORAL 20150313 NDA NDA204417 Sun Pharma Advanced Research Company Limited LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 47133-575_7b66b195-fd76-4dba-9f8b-74e9013180bd 47133-575 HUMAN PRESCRIPTION DRUG Elepsia XR Levetiracetam TABLET, EXTENDED RELEASE ORAL 20150313 NDA NDA204417 Sun Pharma Advanced Research Company Limited LEVETIRACETAM 1500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 47202-1141_1c8a6538-a816-4bba-94a0-0760c10052cb 47202-1141 HUMAN OTC DRUG Moisturizing Hand Sanitizer Ethyl Alcohol LOTION TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Susanne Lang Fragrance Inc. ALCOHOL .62 mL/mL E 20171231 47202-1142_1c8a6538-a816-4bba-94a0-0760c10052cb 47202-1142 HUMAN OTC DRUG Moisturizing Hand Sanitizer Ethyl Alcohol LOTION TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Susanne Lang Fragrance Inc. ALCOHOL .62 mL/mL E 20171231 47202-1143_1c8a6538-a816-4bba-94a0-0760c10052cb 47202-1143 HUMAN OTC DRUG Moisturizing Hand Sanitizer Ethyl Alcohol LOTION TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Susanne Lang Fragrance Inc. ALCOHOL .62 mL/mL E 20171231 47202-1401_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1401 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g E 20171231 47202-1402_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1402 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g E 20171231 47202-1403_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1403 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g E 20171231 47202-1404_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1404 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g E 20171231 47202-1405_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1405 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g E 20171231 47202-1406_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1406 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g E 20171231 47202-1407_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1407 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g E 20171231 47202-1408_a29a0e6b-f9fd-48e3-8e33-7ead0133d5a4 47202-1408 HUMAN OTC DRUG Bite Beauty SPF 15 Sheer Balm Octinoxate Oxybenzone OINTMENT TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g E 20171231 47202-1506_041c1f97-d20d-4bb8-be66-5c2fefe8a720 47202-1506 HUMAN OTC DRUG Lip Love Ultimate Lip Rescue Octinoxate, Oxybenzone KIT 20141003 OTC MONOGRAPH NOT FINAL part352 Susanne Lang Fragrance Inc. E 20171231 47219-102_4f7c4940-c4ba-11de-b031-0002a5d5c51b 47219-102 HUMAN OTC DRUG COBROXIN FOR CHRONIC PAIN NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM .043 mg/mL N 20191231 47219-104_2b33a420-c87f-11de-ab47-0002a5d5c51b 47219-104 HUMAN OTC DRUG COBROXIN FOR CHRONIC PAIN NAJA NAJA VENOM GEL TOPICAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM .02 mg/mL N 20191231 47219-200_62c5a261-fb94-429c-8dcd-912818bd7a88 47219-200 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM SPRAY, METERED ORAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 4 [hp_X]/mL N 20191231 47219-201_9287af80-d915-11de-893d-0002a5d5c51b 47219-201 HUMAN OTC DRUG NYLOXIN Stage 2 Pain Relief NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM .07 mg/mL E 20171231 47219-202_bb43c7e0-d9d0-11de-b59b-0002a5d5c51b 47219-202 HUMAN OTC DRUG NYLOXIN Stage 2 Pain Relief NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM .1 mg/mL E 20171231 47219-203_4817aae0-ddc5-11de-a5b9-0002a5d5c51b 47219-203 HUMAN OTC DRUG NYLOXIN Stage 2 Pain Relief NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM .035 mg/mL E 20171231 47219-204_bd776560-d9ff-11de-8d68-0002a5d5c51b 47219-204 HUMAN OTC DRUG NYLOXIN Stage 2 Pain Relief NAJA NAJA VENOM GEL TOPICAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM .02 mg/mL E 20171231 47219-210_d662abef-a1af-49e2-ba95-4ed6b294ca20 47219-210 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM SPRAY, METERED ORAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 3 [hp_X]/mL N 20191231 47219-250_2ce90140-d912-11de-b0c5-0002a5d5c51b 47219-250 HUMAN OTC DRUG NYLOXIN Stage 3 Pain Relief NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM 140 ug/mL E 20171231 47219-251_7256a740-d931-11de-ae13-0002a5d5c51b 47219-251 HUMAN OTC DRUG NYLOXIN Stage 3 Pain Relief NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM 280 ug/mL E 20171231 47219-252_0fbb0300-d932-11de-8d29-0002a5d5c51b 47219-252 HUMAN OTC DRUG NYLOXIN Stage 3 Pain Relief NAJA NAJA VENOM SPRAY, METERED ORAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM 350 ug/mL E 20171231 47219-253_8d5c7de0-ddbd-11de-9b36-0002a5d5c51b 47219-253 HUMAN OTC DRUG NYLOXIN Stage 3 Pain Relief NAJA NAJA VENOM GEL TOPICAL 20090825 UNAPPROVED HOMEOPATHIC RECEPTOPHARM INC NAJA NAJA VENOM 60 ug/mL E 20171231 47219-300_e9854727-aa35-4f2b-9174-47faf8bb85cc 47219-300 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM GEL TOPICAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 4 [hp_X]/mL N 20191231 47219-300_f281ef65-9576-4006-b79e-fb4963e96c1e 47219-300 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM GEL TOPICAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 4 [hp_X]/mL N 20191231 47219-301_7f5ca81b-075b-46b8-bc3d-d61aacfa3e5d 47219-301 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM GEL TOPICAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 4 [hp_X]/mL N 20191231 47219-310_ed694f5d-a8f0-4219-99fb-cb9abcc272b7 47219-310 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM GEL TOPICAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 4 [hp_X]/mL N 20191231 47219-311_ef6ac736-4094-4c95-9106-9760d9dfadc3 47219-311 HUMAN OTC DRUG Nyloxin NAJA NAJA VENOM GEL TOPICAL 20100823 UNAPPROVED HOMEOPATHIC Receptopharm Inc. NAJA NAJA VENOM 4 [hp_X]/mL N 20191231 47219-341_3fb84585-44d5-472b-8605-9dd01e18e558 47219-341 HUMAN OTC DRUG QPR Quick Pain Relief Naja Naja Venom GEL TOPICAL 20160915 UNAPPROVED HOMEOPATHIC Nutra Pharma Corporation NAJA NAJA VENOM 4 [hp_X]/mL N 20191231 47242-0001_1d1e7751-5353-4d54-b15a-508e764ef95d 47242-0001 HUMAN OTC DRUG Allergy RELIEF ONION - CAUSTICUM - EUPHRASIA STRICTA - SODIUM CHLORIDE - WYETHIA HELENIOIDES ROOT - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ONION; CAUSTICUM; EUPHRASIA STRICTA; SODIUM CHLORIDE; WYETHIA HELENIOIDES ROOT 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0011_ccc4521a-325d-4fb9-a1b3-db9695280d90 47242-0011 HUMAN OTC DRUG Cough and Cold RELIEF ONION - ARSENIC TRIOXIDE - FERROSOFERRIC PHOSPHATE - CANIS LUPUS FAMILIARIS MILK - SODIUM CHLORIDE - STRYCHNOS NUX-VOMICA SEED - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ONION; ARSENIC TRIOXIDE; FERROSOFERRIC PHOSPHATE; CANIS LUPUS FAMILIARIS MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0021_8e3c50ef-5f9e-4c43-bb05-b9531bbd96c8 47242-0021 HUMAN OTC DRUG Flu RELIEF ACONITUM NAPELLUS - CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - ARSENIC TRIOXIDE - BRYONIA ALBA ROOT - GELSEMIUM SEMPERVIRENS ROOT - STRYCHNOS NUX-VOMICA SEED - PULSATILLA VULGARIS - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ACONITUM NAPELLUS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0031_4765bf8e-9bc8-464f-b330-8bc2947ea93c 47242-0031 HUMAN OTC DRUG Hang Over RELIEF ARSENIC TRIOXIDE - IPECAC - STRYCHNOS NUX-VOMICA SEED - VERATRUM ALBUM ROOT - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ARSENIC TRIOXIDE; IPECAC; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0041_8ad67f0e-55d6-46ad-892a-5a0ea55a6a57 47242-0041 HUMAN OTC DRUG Jet Lag RELIEF ACONITUM NAPELLUS - SILVER NITRATE - ARNICA MONTANA - ARSENIC TRIOXIDE - ARABICA COFFEE BEAN - GELSEMIUM SEMPERVIRENS ROOT - STRYCHNOS NUX-VOMICA SEED - TOBACCO LEAF - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ACONITUM NAPELLUS; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; ARABICA COFFEE BEAN; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0051_d8e5810e-7619-4e3c-826c-37012cf8ad3a 47242-0051 HUMAN OTC DRUG PMS RELIEF OYSTER SHELL CALCIUM CARBONATE, CRUDE - POTASSIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - SEPIA OFFICINALIS JUICE - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SEPIA OFFICINALIS JUICE 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0061_afb3dc8b-79f8-4c9c-ad64-077171f1b5f1 47242-0061 HUMAN OTC DRUG Sleep RELIEF ARSENIC TRIOXIDE - ARABICA COFFEE BEAN - NITRIC ACID - TOXICODENDRON PUBESCENS LEAF - SELENIUM - ZINC - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ARSENIC TRIOXIDE; ARABICA COFFEE BEAN; NITRIC ACID; TOXICODENDRON PUBESCENS LEAF; SELENIUM; ZINC 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0071_d2222074-b9f3-40ad-88f0-d6977891b074 47242-0071 HUMAN OTC DRUG Stress RELIEF MATRICARIA RECUTITA - ARABICA COFFEE BEAN - PHYSOSTIGMA VENENOSUM SEED - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. MATRICARIA RECUTITA; ARABICA COFFEE BEAN; PHYSOSTIGMA VENENOSUM SEED 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0081_0eb6cade-4779-4005-9955-345fc79f9b1c 47242-0081 HUMAN OTC DRUG Headache RELIEF BRYONIA ALBA ROOT - GELSEMIUM SEMPERVIRENS ROOT - SANGUINARIA CANADENSIS ROOT - SPIGELIA ANTHELMIA - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0091_e08b6d67-9c24-4eef-93ec-e345e09038ea 47242-0091 HUMAN OTC DRUG Weight Loss RELIEF OYSTER SHELL CALCIUM CARBONATE, CRUDE - IRON - GRAPHITE - POTASSIUM CARBONATE - SODIUM CHLORIDE - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; IRON; GRAPHITE; POTASSIUM CARBONATE; SODIUM CHLORIDE 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0201_42aa8809-b9c8-4690-848b-d9c09a75987f 47242-0201 HUMAN OTC DRUG Childrens Colic RELIEF ANTIMONY TRISULFIDE - MATRICARIA RECUTITA - STRYCHNOS NUX-VOMICA SEED - LYCOPODIUM CLAVATUM SPORE - PULSATILLA VULGARIS - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ANTIMONY TRISULFIDE; MATRICARIA RECUTITA; STRYCHNOS NUX-VOMICA SEED; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0211_540c397b-a7a0-4337-baf1-79bb2bfd9ed5 47242-0211 HUMAN OTC DRUG Childrens Cough and Cold RELIEF ARSENIC TRIOXIDE - FERROSOFERRIC PHOSPHATE - PULSATILLA VULGARIS - SILICON DIOXIDE - DROSERA ROTUNDIFOLIA - SPONGIA OFFICINALIS SKELETON, ROASTED - SAMBUCUS NIGRA FLOWERING TOP - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ARSENIC TRIOXIDE; FERROSOFERRIC PHOSPHATE; PULSATILLA VULGARIS; SILICON DIOXIDE; DROSERA ROTUNDIFOLIA; SPONGIA OFFICINALIS SKELETON, ROASTED; SAMBUCUS NIGRA FLOWERING TOP 6; 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0221_6f1ad4d3-83b8-4e30-90a5-b6390bc8ac9d 47242-0221 HUMAN OTC DRUG Childrens Earache RELIEF ARSENIC TRIOXIDE - MATRICARIA RECUTITA - ACONITUM NAPELLUS - PULSATILLA VULGARIS - MERCURIUS SOLUBILIS - SILICON DIOXIDE - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. ARSENIC TRIOXIDE; MATRICARIA RECUTITA; ACONITUM NAPELLUS; PULSATILLA VULGARIS; MERCURIUS SOLUBILIS; SILICON DIOXIDE 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47242-0231_00aca081-db2e-4c65-8a54-2c20b8ddfbd3 47242-0231 HUMAN OTC DRUG Childrens Teething RELIEF TRIBASIC CALCIUM PHOSPHATE - MATRICARIA RECUTITA - ARABICA COFFEE BEAN - RHEUM OFFICINALE ROOT - TABLET, CHEWABLE ORAL 20090901 UNAPPROVED HOMEOPATHIC Homeostasis Laboratories, Inc. TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; RHEUM OFFICINALE ROOT 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 47285-291_90f66c4a-89a0-4f84-9ae4-6e3f3613f7c6 47285-291 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19410101 UNAPPROVED MEDICAL GAS James C. Dawes Company, Inc OXYGEN 99 L/100L E 20171231 47313-876_d1cc59fc-9339-49b1-8f57-be47e609903c 47313-876 HUMAN OTC DRUG Foamy Mango Antiseptic Hand and Body Wash CHLOROXYLENOL SOAP TOPICAL 20170322 OTC MONOGRAPH NOT FINAL part333E Picolo CHLOROXYLENOL 3 mg/mL N 20181231 47335-001_b5a2261d-8b9a-44b2-971a-f08201fc6080 47335-001 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20121002 NDA AUTHORIZED GENERIC NDA021485 Sun Pharma Global FZE CARBIDOPA; LEVODOPA; ENTACAPONE 12.5; 50; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 47335-002_b5a2261d-8b9a-44b2-971a-f08201fc6080 47335-002 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20121002 NDA AUTHORIZED GENERIC NDA021485 Sun Pharma Global FZE CARBIDOPA; LEVODOPA; ENTACAPONE 18.75; 75; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 47335-003_b5a2261d-8b9a-44b2-971a-f08201fc6080 47335-003 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120401 NDA AUTHORIZED GENERIC NDA021485 Sun Pharma Global FZE CARBIDOPA; LEVODOPA; ENTACAPONE 25; 100; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 47335-004_b5a2261d-8b9a-44b2-971a-f08201fc6080 47335-004 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20121002 NDA AUTHORIZED GENERIC NDA021485 Sun Pharma Global FZE CARBIDOPA; LEVODOPA; ENTACAPONE 31.25; 125; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 47335-005_b5a2261d-8b9a-44b2-971a-f08201fc6080 47335-005 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120401 NDA AUTHORIZED GENERIC NDA021485 Sun Pharma Global FZE CARBIDOPA; LEVODOPA; ENTACAPONE 37.5; 150; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 47335-006_b5a2261d-8b9a-44b2-971a-f08201fc6080 47335-006 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20121002 NDA AUTHORIZED GENERIC NDA021485 Sun Pharma Global FZE CARBIDOPA; LEVODOPA; ENTACAPONE 50; 200; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 47335-007_9cacd238-3e21-4c6e-b12d-85bba995c4de 47335-007 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20130401 NDA AUTHORIZED GENERIC NDA020796 Sun Pharma Global FZE ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 47335-046_cf3dde66-d34e-4950-bea3-673266d21bc8 47335-046 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140409 ANDA ANDA202922 Sun Pharma Global FZE OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 47335-047_cf3dde66-d34e-4950-bea3-673266d21bc8 47335-047 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140409 ANDA ANDA202922 Sun Pharma Global FZE OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 47335-049_41545132-be5c-44e4-ad08-ac5cb90d0a2e 47335-049 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL INTRAVENOUS 20130205 ANDA ANDA203263 Sun Pharma Global FZE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 47335-050_41545132-be5c-44e4-ad08-ac5cb90d0a2e 47335-050 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL INTRAVENOUS 20130205 ANDA ANDA203263 Sun Pharma Global FZE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 47335-082_52e7503a-14bc-4964-8680-6302c1c70a6b 47335-082 HUMAN PRESCRIPTION DRUG LIPODOX Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL INTRAVENOUS 20120209 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Sun Pharma Global FZE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] E 20171231 47335-083_52e7503a-14bc-4964-8680-6302c1c70a6b 47335-083 HUMAN PRESCRIPTION DRUG LIPODOX 50 Doxorubicin Hydrochloride INJECTABLE, LIPOSOMAL INTRAVENOUS 20120209 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Sun Pharma Global FZE DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] E 20171231 47335-144_ccce3205-06b3-494b-9969-b5c2e25b7484 47335-144 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20070910 ANDA ANDA077058 Sun Pharma Global FZE PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 47335-153_9a1ae8f9-ea15-40fc-ba3e-e7a07cd0b705 47335-153 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 20180930 ANDA ANDA078433 Sun Pharma Global FZE GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 47335-154_9a1ae8f9-ea15-40fc-ba3e-e7a07cd0b705 47335-154 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 20181130 ANDA ANDA078433 Sun Pharma Global FZE GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 47335-176_f76206e3-0843-44d3-a372-dab1cf35b3fd 47335-176 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090819 ANDA ANDA078818 Sun Pharma Global FZE OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 47335-178_f76206e3-0843-44d3-a372-dab1cf35b3fd 47335-178 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090819 ANDA ANDA078818 Sun Pharma Global FZE OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 47335-179_e748ea91-3e84-407c-a430-428a567edc31 47335-179 HUMAN PRESCRIPTION DRUG Tetrabenazine Tetrabenazine TABLET ORAL 20150817 ANDA ANDA206129 Sun Pharma Global FZE TETRABENAZINE 25 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20181231 47335-186_8ced5251-9e9d-423a-a3e7-112c2a154448 47335-186 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING ORAL 20141215 ANDA ANDA078690 Sun Pharma Global FZE CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 47335-187_8ced5251-9e9d-423a-a3e7-112c2a154448 47335-187 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING ORAL 20141215 ANDA ANDA078690 Sun Pharma Global FZE CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 47335-188_8ced5251-9e9d-423a-a3e7-112c2a154448 47335-188 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING ORAL 20141215 ANDA ANDA078690 Sun Pharma Global FZE CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 47335-235_0bc03b30-1555-4344-8fb3-f0cc7442b627 47335-235 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate Sodium TABLET ORAL 20171110 ANDA ANDA201749 Sun Pharma Global FZE METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 47335-276_8e235f16-3b8e-4f74-b102-1912dfaaa83e 47335-276 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate INJECTION SUBCUTANEOUS 20110622 ANDA ANDA090358 Sun Pharma Global FZE SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 47335-277_e748ea91-3e84-407c-a430-428a567edc31 47335-277 HUMAN PRESCRIPTION DRUG Tetrabenazine Tetrabenazine TABLET ORAL 20150817 ANDA ANDA206129 Sun Pharma Global FZE TETRABENAZINE 12.5 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20181231 47335-284_8b36f829-1ec3-495f-b56b-bc2a65721c0c 47335-284 HUMAN PRESCRIPTION DRUG carboplatin carboplatin INJECTION INTRAVENOUS 20140303 ANDA ANDA077926 Sun Pharma Global FZE CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 47335-289_32292a4c-91fd-41c3-8e46-3e58489deb46 47335-289 HUMAN PRESCRIPTION DRUG Caffeine Citrate Caffeine Citrate INJECTION INTRAVENOUS 20091001 ANDA ANDA090077 Sun Pharma Global FZE CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 47335-289_d06d3810-9923-4199-be5e-ee5ee086b0a4 47335-289 HUMAN PRESCRIPTION DRUG Caffeine Citrate Caffeine Citrate INJECTION INTRAVENOUS 20140605 ANDA ANDA090077 Sun Pharma Global FZE CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 47335-290_32292a4c-91fd-41c3-8e46-3e58489deb46 47335-290 HUMAN PRESCRIPTION DRUG Caffeine Citrate Caffeine Citrate SOLUTION ORAL 20091001 ANDA ANDA090357 Sun Pharma Global FZE CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 47335-290_d06d3810-9923-4199-be5e-ee5ee086b0a4 47335-290 HUMAN PRESCRIPTION DRUG Caffeine Citrate Caffeine Citrate SOLUTION ORAL 20140602 ANDA ANDA090357 Sun Pharma Global FZE CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 47335-303_4133d373-2c2d-4500-9642-dec58b1af4ce 47335-303 HUMAN PRESCRIPTION DRUG Odomzo sonidegib CAPSULE ORAL 20170921 NDA NDA205266 Sun Pharma Global FZE SONIDEGIB PHOSPHATE 200 mg/1 Hedgehog Pathway Inhibitor [EPC],Smoothened Receptor Antagonists [MoA] N 20181231 47335-307_1ce7e512-404e-488c-8569-a1321c044ef4 47335-307 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170515 ANDA ANDA204170 Sun Pharma Global FZE ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 47335-308_1ce7e512-404e-488c-8569-a1321c044ef4 47335-308 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170515 ANDA ANDA204170 Sun Pharma Global FZE ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 47335-321_60eca5e0-1952-4ef0-ad64-56c11417a7ae 47335-321 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20150711 ANDA ANDA090058 Sun Pharma Global FZE MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 47335-322_60eca5e0-1952-4ef0-ad64-56c11417a7ae 47335-322 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20150711 ANDA ANDA090058 Sun Pharma Global FZE MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 47335-326_64cc17e8-ff8f-463e-aca3-5e85f3f4ec0a 47335-326 HUMAN PRESCRIPTION DRUG NALTREXONE HYDROCHLORIDE NALTREXONE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120229 ANDA ANDA090356 Sun Pharma Global FZE NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 47335-343_269c0a8d-cf20-466a-895d-1869dd9dfccd 47335-343 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20110909 ANDA ANDA090142 Sun Pharma Global FZE CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 47335-343_54812a5b-ce4a-47ff-a481-0ed36ca17f5d 47335-343 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20110926 ANDA ANDA090142 Sun Pharma Global FZE CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 47335-344_269c0a8d-cf20-466a-895d-1869dd9dfccd 47335-344 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20110909 ANDA ANDA090142 Sun Pharma Global FZE CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 47335-344_54812a5b-ce4a-47ff-a481-0ed36ca17f5d 47335-344 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20110926 ANDA ANDA090142 Sun Pharma Global FZE CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 47335-361_37ba1acf-b6b9-4876-a52b-c611e8a9ae53 47335-361 HUMAN PRESCRIPTION DRUG decitabine decitabine KIT 20140124 NDA NDA205582 Sun Pharma Global FZE N 20181231 47335-381_4f11065b-6ff1-4437-a231-dc189edcb284 47335-381 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090745 Sun Pharma Global FZE DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 47335-382_4f11065b-6ff1-4437-a231-dc189edcb284 47335-382 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090745 Sun Pharma Global FZE DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 47335-383_4f11065b-6ff1-4437-a231-dc189edcb284 47335-383 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090745 Sun Pharma Global FZE DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 47335-472_7f760b0e-c989-4521-9f02-45d81f1cae7a 47335-472 HUMAN PRESCRIPTION DRUG imatinib mesylate imatinib mesylate TABLET, FILM COATED ORAL 20160201 ANDA ANDA078340 Sun Pharma Global FZE IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 47335-475_7f760b0e-c989-4521-9f02-45d81f1cae7a 47335-475 HUMAN PRESCRIPTION DRUG imatinib mesylate imatinib mesylate TABLET, FILM COATED ORAL 20160201 ANDA ANDA078340 Sun Pharma Global FZE IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 47335-485_8b533fe4-287f-482c-b530-d9a5bf2ce40c 47335-485 HUMAN PRESCRIPTION DRUG bicalutamide bicalutamide TABLET, FILM COATED ORAL 20141215 ANDA ANDA079110 Sun Pharma Global FZE BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 47335-531_d7372162-343d-4ee1-9106-e32c6659cb1f 47335-531 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111230 ANDA ANDA091607 Sun Pharma Global FZE TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 47335-533_d7372162-343d-4ee1-9106-e32c6659cb1f 47335-533 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111230 ANDA ANDA091607 Sun Pharma Global FZE TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 47335-537_d7372162-343d-4ee1-9106-e32c6659cb1f 47335-537 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111230 ANDA ANDA091607 Sun Pharma Global FZE TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 47335-539_f9dce906-03c1-4834-93ff-cb0697256c54 47335-539 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140627 ANDA ANDA200484 Sun Pharma Global FZE NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 47335-573_c5628447-ec61-47e0-881c-daa20ce73756 47335-573 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130909 ANDA ANDA203059 Sun Pharma Global FZE LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 47335-576_c5628447-ec61-47e0-881c-daa20ce73756 47335-576 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130909 ANDA ANDA203059 Sun Pharma Global FZE LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 47335-580_ccce3205-06b3-494b-9969-b5c2e25b7484 47335-580 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20070910 ANDA ANDA077058 Sun Pharma Global FZE PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 47335-582_77105b58-2dc7-4128-a20a-28a348897183 47335-582 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079169 Sun Pharma Global FZE ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 47335-583_77105b58-2dc7-4128-a20a-28a348897183 47335-583 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079169 Sun Pharma Global FZE ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 47335-584_77105b58-2dc7-4128-a20a-28a348897183 47335-584 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079169 Sun Pharma Global FZE ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 47335-585_77105b58-2dc7-4128-a20a-28a348897183 47335-585 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079169 Sun Pharma Global FZE ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 47335-586_b565d0d0-ce6a-44a3-a908-ea6b6f2c1351 47335-586 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Sun Pharma Global FZE ESZOPICLONE 1 mg/1 CIV N 20181231 47335-587_b565d0d0-ce6a-44a3-a908-ea6b6f2c1351 47335-587 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Sun Pharma Global FZE ESZOPICLONE 2 mg/1 CIV N 20181231 47335-588_b565d0d0-ce6a-44a3-a908-ea6b6f2c1351 47335-588 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Sun Pharma Global FZE ESZOPICLONE 3 mg/1 CIV N 20181231 47335-613_f9dce906-03c1-4834-93ff-cb0697256c54 47335-613 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140627 ANDA ANDA200484 Sun Pharma Global FZE NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 47335-614_f9dce906-03c1-4834-93ff-cb0697256c54 47335-614 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140627 ANDA ANDA201273 Sun Pharma Global FZE NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 47335-666_22863a35-dfea-498d-9004-581769439767 47335-666 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20151130 ANDA ANDA090886 Sun Pharma Global FZE RISEDRONATE SODIUM HEMI-PENTAHYDRATE 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 47335-667_22863a35-dfea-498d-9004-581769439767 47335-667 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20151130 ANDA ANDA090886 Sun Pharma Global FZE RISEDRONATE SODIUM HEMI-PENTAHYDRATE 30 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 47335-668_22863a35-dfea-498d-9004-581769439767 47335-668 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20151130 ANDA ANDA090886 Sun Pharma Global FZE RISEDRONATE SODIUM HEMI-PENTAHYDRATE 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 47335-669_eed38e8d-b118-46e1-8566-f427a46341d8 47335-669 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101115 ANDA ANDA090421 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 47335-670_eed38e8d-b118-46e1-8566-f427a46341d8 47335-670 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101115 ANDA ANDA090421 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 47335-671_eed38e8d-b118-46e1-8566-f427a46341d8 47335-671 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101115 ANDA ANDA090421 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 47335-672_eed38e8d-b118-46e1-8566-f427a46341d8 47335-672 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101115 ANDA ANDA090421 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 47335-673_eed38e8d-b118-46e1-8566-f427a46341d8 47335-673 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101115 ANDA ANDA090421 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 47335-675_557198bb-070a-464a-aa83-862d2dd0a3cc 47335-675 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 47335-676_557198bb-070a-464a-aa83-862d2dd0a3cc 47335-676 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 47335-677_557198bb-070a-464a-aa83-862d2dd0a3cc 47335-677 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 47335-678_557198bb-070a-464a-aa83-862d2dd0a3cc 47335-678 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 47335-679_557198bb-070a-464a-aa83-862d2dd0a3cc 47335-679 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Sun Pharma Global FZE DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 47335-707_7401d4f7-470d-493f-9754-f0d913f060d4 47335-707 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 Sun Pharma Global FZE TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 47335-710_7401d4f7-470d-493f-9754-f0d913f060d4 47335-710 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 Sun Pharma Global FZE TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 47335-711_7401d4f7-470d-493f-9754-f0d913f060d4 47335-711 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 Sun Pharma Global FZE TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 47335-712_7401d4f7-470d-493f-9754-f0d913f060d4 47335-712 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 Sun Pharma Global FZE TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 47335-724_f23a4cbb-39b3-4c19-aeb4-11229c1c82bd 47335-724 HUMAN OTC DRUG Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150213 ANDA ANDA090818 Sun Pharma Global FZE FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 N 20181231 47335-727_22863a35-dfea-498d-9004-581769439767 47335-727 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140611 ANDA ANDA090886 Sun Pharma Global FZE RISEDRONATE SODIUM HEMI-PENTAHYDRATE 75 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 47335-758_ced3cd91-28bf-4bde-9f71-099374968130 47335-758 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141215 ANDA ANDA091272 Sun Pharma Global FZE VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 47335-759_ced3cd91-28bf-4bde-9f71-099374968130 47335-759 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141215 ANDA ANDA091272 Sun Pharma Global FZE VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 47335-760_ced3cd91-28bf-4bde-9f71-099374968130 47335-760 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141215 ANDA ANDA091272 Sun Pharma Global FZE VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 47335-779_540d2e65-b32c-4f73-b76b-f034a19aa1d3 47335-779 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine Hydrochloride SPRAY, METERED NASAL 20120524 ANDA ANDA090423 Sun Pharma Global FZE AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 47335-788_65420316-3251-490b-a0ef-e4cfec5cc384 47335-788 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate SOLUTION NASAL 20131224 ANDA ANDA078271 Sun Pharma Global FZE DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 47335-814_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-814 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] E 20171231 47335-815_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-815 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] E 20171231 47335-816_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-816 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] E 20171231 47335-817_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-817 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] E 20171231 47335-818_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-818 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] E 20171231 47335-819_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-819 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] E 20171231 47335-820_76b8f7da-7e69-4953-be59-e38397e0fd36 47335-820 HUMAN PRESCRIPTION DRUG Atomoxetine Hydrochloride Atomoxetine Hydrochloride CAPSULE ORAL 20101005 ANDA ANDA079020 Sun Pharma Global FZE ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] E 20171231 47335-835_ce300fc0-d9df-4198-9dd1-a7ca6b70ab9e 47335-835 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20110209 ANDA ANDA090178 Sun Pharma Global FZE GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 47335-836_ce300fc0-d9df-4198-9dd1-a7ca6b70ab9e 47335-836 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20110209 ANDA ANDA090178 Sun Pharma Global FZE GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 47335-837_ce300fc0-d9df-4198-9dd1-a7ca6b70ab9e 47335-837 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20110209 ANDA ANDA090178 Sun Pharma Global FZE GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 47335-859_584fe60c-240f-4459-9b54-d9925e41ce1f 47335-859 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111212 ANDA ANDA201384 Sun Pharma Global FZE TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 47335-860_584fe60c-240f-4459-9b54-d9925e41ce1f 47335-860 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111212 ANDA ANDA201384 Sun Pharma Global FZE TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 47335-861_584fe60c-240f-4459-9b54-d9925e41ce1f 47335-861 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111212 ANDA ANDA201384 Sun Pharma Global FZE TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 47335-890_b44325c2-063c-4c1f-871e-1d4392f83d4d 47335-890 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20140213 ANDA ANDA201742 Sun Pharma Global FZE TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 47335-891_b44325c2-063c-4c1f-871e-1d4392f83d4d 47335-891 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20140213 ANDA ANDA201742 Sun Pharma Global FZE TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 47335-892_b44325c2-063c-4c1f-871e-1d4392f83d4d 47335-892 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20140213 ANDA ANDA201742 Sun Pharma Global FZE TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 47335-893_b44325c2-063c-4c1f-871e-1d4392f83d4d 47335-893 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20140213 ANDA ANDA201742 Sun Pharma Global FZE TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 47335-894_1f16d2b1-86a9-4c55-9243-a2f57ccb8799 47335-894 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120518 ANDA ANDA090494 Sun Pharma Global FZE CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 47335-902_7fe07db8-c9a2-41e4-b846-624e48ac7bb9 47335-902 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Sun Pharma Global FZE QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 47335-903_7fe07db8-c9a2-41e4-b846-624e48ac7bb9 47335-903 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Sun Pharma Global FZE QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 47335-904_7fe07db8-c9a2-41e4-b846-624e48ac7bb9 47335-904 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Sun Pharma Global FZE QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 47335-905_7fe07db8-c9a2-41e4-b846-624e48ac7bb9 47335-905 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Sun Pharma Global FZE QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 47335-906_7fe07db8-c9a2-41e4-b846-624e48ac7bb9 47335-906 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Sun Pharma Global FZE QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 47335-907_7fe07db8-c9a2-41e4-b846-624e48ac7bb9 47335-907 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Sun Pharma Global FZE QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 47335-909_eea0886a-3b9d-43e8-aadb-df78926e62cc 47335-909 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120522 20180331 ANDA ANDA079085 Sun Pharma Global FZE CARBIDOPA; LEVODOPA; ENTACAPONE 25; 100; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 47335-910_eea0886a-3b9d-43e8-aadb-df78926e62cc 47335-910 HUMAN PRESCRIPTION DRUG Carbidopa, levodopa and entacapone Carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120522 20180331 ANDA ANDA079085 Sun Pharma Global FZE CARBIDOPA; LEVODOPA; ENTACAPONE 37.5; 150; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 47335-923_9bd78c0b-1bee-44af-a6d8-a742872470b3 47335-923 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130916 ANDA ANDA202637 Sun Pharma Global FZE LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 47335-924_9bd78c0b-1bee-44af-a6d8-a742872470b3 47335-924 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130916 ANDA ANDA091509 Sun Pharma Global FZE LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 47335-928_22863a35-dfea-498d-9004-581769439767 47335-928 HUMAN PRESCRIPTION DRUG risedronate sodium risedronate sodium TABLET, FILM COATED ORAL 20140611 ANDA ANDA090886 Sun Pharma Global FZE RISEDRONATE SODIUM HEMI-PENTAHYDRATE 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 47335-929_b44325c2-063c-4c1f-871e-1d4392f83d4d 47335-929 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20140213 ANDA ANDA201742 Sun Pharma Global FZE TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 47335-930_b44325c2-063c-4c1f-871e-1d4392f83d4d 47335-930 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20140213 ANDA ANDA201742 Sun Pharma Global FZE TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 47335-931_a14da3ee-a731-4282-be9d-407473517470 47335-931 HUMAN PRESCRIPTION DRUG vecuronium bromide vecuronium bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141215 ANDA ANDA079001 Sun Pharma Global FZE VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 47335-932_a14da3ee-a731-4282-be9d-407473517470 47335-932 HUMAN PRESCRIPTION DRUG vecuronium bromide vecuronium bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141215 ANDA ANDA079001 Sun Pharma Global FZE VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] E 20171231 47335-936_f1c11763-f8de-477f-86a1-1d9abe60da5e 47335-936 HUMAN PRESCRIPTION DRUG leuprolide acetate leuprolide acetate KIT 20141215 ANDA ANDA078885 Sun Pharma Global FZE N 20181231 47335-938_81e4a7c3-5448-47d2-bdf8-daa851be2387 47335-938 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine Hydrochloride SOLUTION/ DROPS INTRAOCULAR 20100531 ANDA ANDA078738 Sun Pharma Global FZE AZELASTINE HYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 47335-954_9dfd975a-5db3-47ed-84c7-abf785a0481e 47335-954 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141225 ANDA ANDA200695 Sun Pharma Global FZE BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 47335-956_c1492c00-7dea-4ffa-b19c-daa24f2bba85 47335-956 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111122 ANDA ANDA079057 Sun Pharma Global FZE ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 47341-002_a6b5ed46-bf0e-4e9e-8ced-a6645ee59148 47341-002 HUMAN OTC DRUG Burn-B Gone OTC Burn-B Gone OTC GEL TOPICAL 20100510 OTC MONOGRAPH FINAL part347 Quantum Labs LLC ALLANTOIN .75 g/75g E 20171231 47426-101_f8caa49c-a077-484b-80a8-fdd95a831515 47426-101 HUMAN PRESCRIPTION DRUG SUSTOL granisetron INJECTION SUBCUTANEOUS 20160809 NDA NDA022445 Heron Therapeutics GRANISETRON 10 mg/.4mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 47426-201_391a3e41-b2d5-453b-9f07-7ab477326575 47426-201 HUMAN PRESCRIPTION DRUG CINVANTI aprepitant INJECTION, EMULSION INTRAVENOUS 20180103 NDA NDA209296 Heron Therapeutics APREPITANT 130 mg/18mL Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 47444-001_43876265-2e4b-42a0-aaf2-617a41173d44 47444-001 HUMAN OTC DRUG Salicylic Acid Bosye Benefiting Hair Lotion LOTION TOPICAL 20090101 OTC MONOGRAPH FINAL part358H Bejing Rimeng Biological Technology Co Ltd SALICYLIC ACID .5 g/60mL E 20171231 47469-140_168f82f6-f52e-40d7-b2b9-79e500dfc005 47469-140 HUMAN OTC DRUG HANSKIN AIR BOUNCE CUSHION BB No 21 Light Beige Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.9; 1; .6 g/15g; g/15g; g/15g N 20181231 47469-150_ca97d544-ec68-44c9-a5b9-df042a8c2ff9 47469-150 HUMAN OTC DRUG HANSKIN AIR BOUNCE CUSHION BB No 23 Natural Beige Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.9; 1; .6 g/15g; g/15g; g/15g N 20181231 47469-160_d01f25a9-9455-4911-bc05-54667620aff1 47469-160 HUMAN OTC DRUG HANSKIN BIO ORIGIN ROYAL AMPOULE BB EX Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.61; 1.6; .78 g/40mL; g/40mL; g/40mL N 20181231 47469-170_232e5fc1-81ad-4b48-9e11-b3ab7648cb0a 47469-170 HUMAN OTC DRUG HANSKIN BIO ORIGIN THE AMPOULE SERUM Dimethicone CREAM TOPICAL 20160701 OTC MONOGRAPH FINAL part347 Celltrion Skincure Co.,Ltd. DIMETHICONE 1.5 g/60mL N 20181231 47469-180_b3232ffa-77a2-4211-88b4-b7b01679f2b9 47469-180 HUMAN OTC DRUG HANSKIN CELL COVER FOUNDATION NO 21 LIGHT BEIGE Titanium Dioxide, Octinoxate POWDER TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. TITANIUM DIOXIDE; OCTINOXATE 1.92; 1 g/20g; g/20g N 20181231 47469-190_08ba36a2-7bd9-4904-8770-4cda3990b663 47469-190 HUMAN OTC DRUG HANSKIN CELL COVER FOUNDATION NO 23 NATURAL BEIGE Titanium Dioxide, Octinoxate POWDER TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. TITANIUM DIOXIDE; OCTINOXATE 1.92; 1 g/20g; g/20g N 20181231 47469-200_859481fd-6577-4e66-843e-6ff731b94228 47469-200 HUMAN OTC DRUG HANSKIN REAL COMPLEXION Niacinamide CREAM TOPICAL 20160701 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. NIACINAMIDE 1 g/50g N 20181231 47469-210_4421992e-9f81-4772-a0c0-4374dd7df18e 47469-210 HUMAN OTC DRUG HANSKIN HYALURON SKIN ESSENCE Glycerin LIQUID TOPICAL 20160701 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. GLYCERIN 9 g/300mL N 20181231 47469-220_555f852e-b819-4198-984d-e13de4ecbdaf 47469-220 HUMAN OTC DRUG HANSKIN SUPER LIGHT TOUCH BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.13; .43 g/30g; g/30g N 20181231 47469-230_3404e36a-55c5-40d7-bee8-7c00cc6debf8 47469-230 HUMAN OTC DRUG HANSKIN PREMIUM PERFECT SUPER MAGIC BB Titanium Dioxide, Octinoxate CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. TITANIUM DIOXIDE; OCTINOXATE 4.96; 1.35 g/45g; g/45g N 20181231 47469-240_1c15684f-4fe3-4f48-a04c-540b4bc61679 47469-240 HUMAN OTC DRUG HANSKIN BIO ORIGIN 369 SUNFLOWER OIL TOPICAL 20161220 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. SUNFLOWER OIL 19.13 g/30mL N 20181231 47469-250_62edf31a-d88f-4eb8-b9e0-56567e6a367d 47469-250 HUMAN OTC DRUG HANSKIN BIO ORIGIN THE Niacinamide, Adenosine CREAM TOPICAL 20161220 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 47469-260_76d707a2-e145-4e32-87f3-67cfcc3778c9 47469-260 HUMAN OTC DRUG HANSKIN BIO ORIGIN THE EYE Dimethicone CREAM TOPICAL 20161220 OTC MONOGRAPH FINAL part347 Celltrion Skincure Co.,Ltd. DIMETHICONE 1.01 g/30mL N 20181231 47469-270_b15a57a1-6648-477b-8a6f-55c0b56e02d4 47469-270 HUMAN OTC DRUG HANSKIN BIO PRISM BRIGHTENING ALPHA SERUM Niacinamide LIQUID TOPICAL 20161220 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. NIACINAMIDE 2 g/100mL N 20181231 47469-280_13c806f9-8071-4e46-9122-af4851adb57c 47469-280 HUMAN OTC DRUG DEARSIR Gentle Relief Cleansing Fo am Glycerin GEL TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Celltrion Skincure Co.,Ltd. GLYCERIN 37.5 g/150mL N 20181231 47469-290_567309e6-8402-4657-b1ec-79783cdd5469 47469-290 HUMAN OTC DRUG DEARSIR Aqua Shuttle Essence Skin Glycerin, Dimethicone LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. GLYCERIN; DIMETHICONE 2.32; .96 g/140mL; g/140mL N 20181231 47469-300_c32c861f-7bd4-4482-9873-358a456bbfdb 47469-300 HUMAN OTC DRUG DEARSIR Perfection Fluid Glycerin, Dimethicone CREAM TOPICAL 20170701 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. GLYCERIN; DIMETHICONE 6.5; .81 g/130mL; g/130mL N 20181231 47469-310_b56b364d-3fd5-43b6-a9f0-9c241e69ea3c 47469-310 HUMAN OTC DRUG DEARSIR Age Defying Serum Dimethicone CREAM TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Celltrion Skincure Co.,Ltd. DIMETHICONE 2.92 g/75mL N 20181231 47469-320_3eb2bbec-699d-4e57-ba55-30f94dd50848 47469-320 HUMAN OTC DRUG DEARSIR UV Ultra Protection Sun Zinc Oxide, Octinoxate, Octisalate, Titanium Dioxide CREAM TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. ZINC OXIDE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 4.95; 3.4; 2.25; 2 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 47469-330_d7b2e965-3168-4435-9174-fb9655b8985b 47469-330 HUMAN OTC DRUG Peaufinee Baby and Kids Sun Titanium Dioxide CREAM TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. TITANIUM DIOXIDE 2.94 g/70mL N 20181231 47469-340_aa253df2-15f8-4966-9de9-78d19771b2ce 47469-340 HUMAN OTC DRUG Peaufinee Moisturizing Soothing Dimethicone LOTION TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Celltrion Skincure Co.,Ltd. DIMETHICONE 2.7 g/180mL N 20181231 47469-350_c91a3fd1-037d-478e-9ecb-4ea778b013c5 47469-350 HUMAN OTC DRUG HANSKIN REAL COMPLEXION CRE AM EX Niacinamide, Adenosine CREAM TOPICAL 20170701 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. NIACINAMIDE; ADENOSINE 1; .02 g/50g; g/50g N 20181231 47469-360_9c3733f4-40fe-4714-945d-59e6011af8c9 47469-360 HUMAN OTC DRUG HANSKIN BiO CLEAR PEP MASK Brightening and Moisture Niacinamide PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. NIACINAMIDE .59 g/27g N 20181231 47469-370_24f84d46-5568-46d3-9074-42d3eeee65b0 47469-370 HUMAN OTC DRUG HANSKIN BiO POWER PEP MASK Moisture and Vitality Niacinamide PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. NIACINAMIDE .59 g/27g N 20181231 47469-380_3c4fbd31-def5-4d4c-a63b-65d699bee8be 47469-380 HUMAN OTC DRUG HANSKIN BiO FILL PEP MASK Firming and Moisture Niacinamide PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. NIACINAMIDE .59 g/27g N 20181231 47469-390_f278ef65-f014-4959-a412-620bba3e35d9 47469-390 HUMAN OTC DRUG Hanskin Vstra toning water radiance Niacinamide, Adenosine CREAM TOPICAL 20170801 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 47469-400_81bcbafa-bd37-43e1-8db7-38d02da994d3 47469-400 HUMAN OTC DRUG Hanskin Vistra toner mask pad Niacinamide, Adenosine LIQUID TOPICAL 20170801 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. NIACINAMIDE; ADENOSINE 5; .1 g/250mL; g/250mL N 20181231 47469-410_cd859ef3-fff5-4e2e-a216-c7d9214f46d7 47469-410 HUMAN OTC DRUG Hanskin nontouring gradation pact L21 fair Serum cover balm Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide POWDER TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE .8; .57; .19; .18 g/9.5g; g/9.5g; g/9.5g; g/9.5g N 20181231 47469-420_017ff065-5fc5-4c92-9cd9-c8d3d258f985 47469-420 HUMAN OTC DRUG Hanskin nontouring gradation pact L21 fair Edge cover balm Octinoxate, Octisalate, Titanium Dioxide POWDER TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .28; .17; .07 g/4.2g; g/4.2g; g/4.2g N 20181231 47469-430_726d499d-5aad-4726-bed1-ba64578daa9a 47469-430 HUMAN OTC DRUG Hanskin nontouring gradation pact M22 nude Serum cover balm Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide POWDER TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE .8; .57; .19; .18 g/9.5g; g/9.5g; g/9.5g; g/9.5g N 20181231 47469-440_0ea864bc-c8a1-44be-b924-698ea33de287 47469-440 HUMAN OTC DRUG Hanskin nontouring gradation pact M22 nude Edge cover balm Octinoxate, Octisalate, Titanium Dioxide POWDER TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Celltrion Skincure Co.,Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .28; .17; .07 g/4.2g; g/4.2g; g/4.2g N 20181231 47469-450_f23d51ff-9f2b-4b89-a015-7ac4c7f31dd9 47469-450 HUMAN OTC DRUG HANSKIN BIO PRISM BRIGHTENING FO AMING CLEANSER Glycerin LIQUID TOPICAL 20170801 OTC MONOGRAPH FINAL part347 Celltrion Skincure Co.,Ltd. GLYCERIN 30 g/150mL N 20181231 47469-460_887a1105-67c4-4b1d-ba4c-3c4035b22c60 47469-460 HUMAN OTC DRUG HANSKIN SUPER THREE SOLU TION VITA BRIGHTENING SHEET MASK Niacinamide PATCH TOPICAL 20171001 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. NIACINAMIDE .5 g/25mL N 20181231 47469-470_969a4a8c-a834-4741-90d6-57655591bf8c 47469-470 HUMAN OTC DRUG HANSKIN SUPER THREE SOLU TION AQUA FIRMING SHEET MASK Adenosine PATCH TOPICAL 20171001 UNAPPROVED DRUG OTHER Celltrion Skincure Co.,Ltd. ADENOSINE .01 g/25mL N 20181231 47584-001_8c60f6f1-db86-4f23-bdc5-7af36e37bc95 47584-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20111208 ANDA ANDA203665 Cyclotron Partners LP dba Cyclotope FLUDEOXYGLUCOSE F-18 500 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 47584-002_d31845a1-1be5-4da1-a08f-2600eb0a663f 47584-002 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20111208 ANDA ANDA203544 Houston Cyclotron Partners LP dba Cyclotope SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 47584-003_353bd7ef-caa5-4360-b1ec-2f068c7008fd 47584-003 HUMAN PRESCRIPTION DRUG Ammonia N 13 AMMONIA N-13 INJECTION INTRAVENOUS 20110804 ANDA ANDA203543 Houston Cyclotron Partners LP dba Cyclotope AMMONIA N-13 260 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 47593-169_7288a68f-da3c-494e-ab21-37d395969857 47593-169 HUMAN OTC DRUG Bacti-Foam Triclosan SOLUTION TOPICAL 19970711 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-170_770900c9-46e7-451f-a03d-8dd037155992 47593-170 HUMAN OTC DRUG Bacti-Stat AE Triclosan SOLUTION TOPICAL 19970714 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3.06 mg/mL N 20181231 47593-178_5831cd36-c41a-49f8-b593-cb9ce0fe99eb 47593-178 HUMAN OTC DRUG Bacti-Stat triclosan SOLUTION TOPICAL 19970123 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3.06 mg/mL N 20181231 47593-244_f863d7f2-420d-412f-8518-4af0112d8b1c 47593-244 HUMAN OTC DRUG Endure 250 Triclosan SOLUTION TOPICAL 19990608 20180505 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 10.3 mg/mL N 20191231 47593-262_b539693d-596b-404f-823d-008b28f17d6d 47593-262 HUMAN OTC DRUG Endure 100 Triclosan SOLUTION TOPICAL 19981120 20180428 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 2.05 mg/mL N 20191231 47593-263_02f2ad0a-35f3-4829-916f-2773e903a484 47593-263 HUMAN OTC DRUG Endure 200 Triclosan SOLUTION TOPICAL 19981120 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 10.35 mg/mL N 20181231 47593-264_92519d5b-2b73-411e-b4de-5a9ed83cf07a 47593-264 HUMAN OTC DRUG Endure 300 Cida Rinse Gel Antimicrobial Hand Rinse Antiseptic handwash SOLUTION TOPICAL 19991122 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 70 mL/100mL N 20181231 47593-265_2acfa1bc-b658-4542-b843-34bae79ffbad 47593-265 HUMAN OTC DRUG Endure 400 Scrub-Stat 4 Chlorhexidine gluconate SOLUTION TOPICAL 20061001 NDA NDA019258 Ecolab Inc. CHLORHEXIDINE GLUCONATE 40 mg/mL N 20181231 47593-266_bbcda0bb-1e29-4c61-bdee-f0bef163dc9b 47593-266 HUMAN OTC DRUG EpiCare Plus Antimicrobial Skin Cleanser Antiseptic handwash SOLUTION TOPICAL 19990416 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. TRICLOSAN .3 mL/100mL N 20181231 47593-275_5d9a48ca-4adb-457e-b6ca-902ebc5a71ad 47593-275 HUMAN OTC DRUG EcoCare 360 Benzalkonium SOLUTION TOPICAL 19990223 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE .1 mg/100mL N 20181231 47593-279_41f63e7b-8fd5-4f6b-97a2-29cd66d74d1c 47593-279 HUMAN OTC DRUG Alphadine Scrub Topical Microbiocidal Skin Cleanser Surgical Hand Scrub/General Skin Cleanser SOLUTION TOPICAL 19970619 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. IODINE 7.5 mL/100mL N 20181231 47593-280_c9f9dc8f-33ba-45b6-804f-f3ab66990c5e 47593-280 HUMAN OTC DRUG Quik-Care Waterless Antimicrobial Foaming Hand Rub Antiseptic handwash SOLUTION TOPICAL 19990506 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 54.7 g/100g N 20181231 47593-284_bb7ed87f-bb79-4d98-b1ad-3fc1b023b11a 47593-284 HUMAN OTC DRUG Clean Force chloroxylenol SOLUTION TOPICAL 19990601 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL .6 mL/100mL N 20181231 47593-303_2467fb34-cd37-42a8-a4d9-85b2e575d079 47593-303 HUMAN OTC DRUG Endure 420 Cida-Stat Chlorhexidine gluconate SOLUTION TOPICAL 20061001 NDA NDA019258 Ecolab Inc. CHLORHEXIDINE GLUCONATE 20 mg/mL N 20181231 47593-305_e38e7304-db64-4dda-ad8f-ea565c8f95a9 47593-305 HUMAN OTC DRUG DigiClean E Triclosan SOLUTION TOPICAL 19990526 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-307_286cd573-f926-4fbe-901c-3c716c704377 47593-307 HUMAN OTC DRUG Ecolab Digiclean Triclosan SOLUTION TOPICAL 19990526 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-308_6b75ccad-4c21-468f-961d-4c4b1816d376 47593-308 HUMAN OTC DRUG DigiClean E Antiseptic handwash SOLUTION TOPICAL 19990526 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 1 mg/100mL N 20181231 47593-311_4152f071-8e61-4d29-89b9-f9e8f15dadf0 47593-311 HUMAN OTC DRUG DigiSan Hand Sanitizer Alcohol SOLUTION TOPICAL 20010110 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 54.7 g/100g N 20181231 47593-316_714cef2b-b73c-4bda-8d57-ff6abb78f109 47593-316 HUMAN OTC DRUG Puritan Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 19990628 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 60 mL/100mL N 20181231 47593-336_cf32e7d3-8538-493b-9c45-a2fac8d92d9f 47593-336 HUMAN OTC DRUG EpiSoft Foaming Antibacterial Lotin Soap Antiseptic handwash SOLUTION TOPICAL 20000310 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. TRICLOSAN .3 mL/100mL N 20181231 47593-341_ec6f0217-50f2-4d87-b1e0-a236ce0f41c8 47593-341 HUMAN OTC DRUG Keystone triclosan SOLUTION TOPICAL 20000726 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mg/100mL N 20181231 47593-356_4d8ea810-5194-4909-894e-db7a0742ddaf 47593-356 HUMAN OTC DRUG Renown Antiseptic Hand Cleaner for Gentle Hand Care Antiseptic handwash SOLUTION TOPICAL 20010716 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. CHLOROXYLENOL .8 mL/100mL N 20181231 47593-359_d0d84700-2acd-4928-9e63-306e8c1269a5 47593-359 HUMAN OTC DRUG Keystone Benzalkonium Chloride SOLUTION TOPICAL 20020726 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE .1 mg/100mL N 20181231 47593-360_b9a7db20-b6da-402e-bc31-a7fa25ba5032 47593-360 HUMAN OTC DRUG EcoCare 250 Triclosan SOLUTION TOPICAL 20020831 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-362_98812405-df7c-4215-9c0b-420ae8d955ee 47593-362 HUMAN OTC DRUG EcoCare 270 Antiseptic handwash SOLUTION TOPICAL 20020831 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL .9 mg/100mL N 20181231 47593-363_7563adf0-cf77-4069-a44a-0ad1a9e3716c 47593-363 HUMAN OTC DRUG EcoCare 350 Hand Sanitizer with Skin Conditioner Antiseptic hand wash SOLUTION TOPICAL 20021226 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ISOPROPYL ALCOHOL 75 mL/100mL N 20181231 47593-381_e4aa4d25-d5a4-4d8b-b449-f958f34b8896 47593-381 HUMAN OTC DRUG DigiClean Slim-Line Triclosan SOLUTION TOPICAL 20030415 OTC MONOGRAPH FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL N 20181231 47593-383_79eeebc1-0d8b-4107-8acc-12d90cc5bc25 47593-383 HUMAN OTC DRUG Eco-Clean Elite Triclosan SOLUTION TOPICAL 20040830 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL N 20181231 47593-385_39023364-945a-45ab-a038-e536b9295d09 47593-385 HUMAN OTC DRUG Eco-Clean Elite Foam Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 20020809 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 47593-387_1e1fdc60-3b46-41f2-af17-a8323d5524a8 47593-387 HUMAN OTC DRUG DigiClean Slim-Line Hand Sanitizer Benzalkonim chloride SOLUTION TOPICAL 20020726 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 47593-388_b2559151-5be4-4005-8c5f-9a0c865244cf 47593-388 HUMAN OTC DRUG DIGISAN Healthcare Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 20040317 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 70 mL/100mL N 20181231 47593-390_9d7db6e2-6861-4502-ba01-7d32a87026f1 47593-390 HUMAN OTC DRUG Digiclean Triclosan SOLUTION TOPICAL 20031027 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-391_977d26ec-88e1-465c-83d9-21357e7d84de 47593-391 HUMAN OTC DRUG Clean Force Triclosan SOLUTION TOPICAL 20040729 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mg/100mL N 20181231 47593-392_5cacdeda-119c-4f09-bdca-982673ecb9c0 47593-392 HUMAN OTC DRUG Puritan Triclosan SOLUTION TOPICAL 20040729 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL N 20181231 47593-404_0c37af16-4b95-4638-bc76-a1c31cbc0730 47593-404 HUMAN OTC DRUG DigiSan E Benzalkonium chloride SOLUTION TOPICAL 20031104 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 47593-406_a6e268c4-2d9f-417a-8395-69850a85a2e2 47593-406 HUMAN OTC DRUG Clean Force Ethyl Alcohol SOLUTION TOPICAL 20031027 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 60 mL/100mL N 20181231 47593-408_f18a21c8-a592-4214-af70-d8def8e80043 47593-408 HUMAN OTC DRUG Endure 320 Advanced Care Waterless Antimicrobial Hand Rinse with Moisturizers Anitspetic handwash SOLUTION TOPICAL 20031027 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 62 mL/100mL N 20181231 47593-409_887e7900-eb81-417e-aebe-bed45393aa42 47593-409 HUMAN OTC DRUG DigiSan Alcohol AEROSOL, FOAM TOPICAL 20031031 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 62.5 g/100g N 20181231 47593-410_ec3afee2-4612-435b-9ce3-7027635d6ae4 47593-410 HUMAN OTC DRUG Clean Force Foam Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20031027 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 47593-413_ba01b446-79d4-42ae-82a4-1994fa54b477 47593-413 HUMAN OTC DRUG Endure 300 Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 20050531 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 70 mL/100mL N 20181231 47593-416_c1c2f7c4-9f03-4c53-a46c-7072cb52edbf 47593-416 HUMAN OTC DRUG Keystone Classic Foam Hand Sanitizer Antiseptic handwash SOLUTION TOPICAL 20040317 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 47593-428_31388222-7a5b-4599-a6b9-cbdd55bcf876 47593-428 HUMAN OTC DRUG DigiKlenz Antibacterial Hand Soap Antiseptic handwash SOLUTION TOPICAL 20051007 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. TRICLOSAN .3 mL/100mL N 20181231 47593-431_bac2ba50-fcf4-473d-8f0a-d061a6f953ca 47593-431 HUMAN OTC DRUG Endure 450 Surgical and Healthcare Personnel Hand Antiseptic with Moisturizers Alcohol hand sanitizer SOLUTION TOPICAL 20051128 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. ETHANOL 62 mL/100mL N 20181231 47593-438_f14e28ac-44ad-49d7-8aeb-56b9ed587b47 47593-438 HUMAN OTC DRUG Proforce Commercial Products Triclosan SOLUTION TOPICAL 20080310 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-443_402263cc-b6af-420a-9f0d-d90bd9b6143f 47593-443 HUMAN OTC DRUG Antibacterial Clean and Smooth Gentle Skin Cleanser Triclosan SOLUTION TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-454_a191b382-9a23-42ef-a04e-dec63f1dde78 47593-454 HUMAN OTC DRUG Non-Aerosol Antimicrobial Foam Hand Rub Antiseptic handwash SOLUTION TOPICAL 20080115 OTC MONOGRAPH NOT FINAL part333 Ecolab Inc. BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 47593-457_a7fb6386-bcb5-4922-86e0-e3e0a3ce70e4 47593-457 HUMAN OTC DRUG Quik-Care Ethyl Alcohol SOLUTION TOPICAL 20081029 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 620 mg/mL N 20181231 47593-458_98e3aa83-0d05-4b0d-81c8-e3d4a26c55f3 47593-458 HUMAN OTC DRUG Quik-Care Alcohol SOLUTION TOPICAL 20090116 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 620 mg/mL N 20181231 47593-459_0be2b36b-9ecf-47d9-9d15-399924e7120b 47593-459 HUMAN OTC DRUG Ecolab Facilipro triclosan SOLUTION TOPICAL 20080904 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-462_1a6f270d-25b0-4f46-81d0-f8f759bcdad5 47593-462 HUMAN OTC DRUG Keystone Antibacterial Triclosan SOLUTION TOPICAL 20091111 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-463_edbfc9d7-3362-441c-a148-f1d3b68bd7ed 47593-463 HUMAN OTC DRUG Scrub-Stat Chlorhexidine gluconate SOLUTION TOPICAL 19860722 NDA NDA019258 Ecolab Inc. CHLORHEXIDINE GLUCONATE 20 mg/mL N 20181231 47593-464_df58999b-211e-4ac3-bd15-a9c837cb0d5d 47593-464 HUMAN OTC DRUG Scrub-Stat Chlorhexidine gluconate SOLUTION TOPICAL 19860722 NDA NDA019258 Ecolab Inc. CHLORHEXIDINE GLUCONATE 40 mg/mL N 20181231 47593-465_260cb042-7035-4fb8-9347-59f0b62277a5 47593-465 HUMAN OTC DRUG Ecolab Keystone Chloroxylenol SOLUTION TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5 mg/mL N 20181231 47593-466_4e6a22d5-64a8-4b60-8f06-a781563bac90 47593-466 HUMAN OTC DRUG Keystone Liquid Hand Sanitizer Alcohol SOLUTION TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 60 mL/100mL N 20181231 47593-467_368151a4-20c8-415e-8d8a-deadc4896b47 47593-467 HUMAN OTC DRUG Scrub-Stat Chlorhexidine gluconate SOLUTION TOPICAL 20110303 NDA NDA019258 Ecolab Inc. CHLORHEXIDINE GLUCONATE 20 mg/mL N 20181231 47593-468_83a1becc-b0d7-4f96-872d-1693123d1bcd 47593-468 HUMAN OTC DRUG Scrub-Stat Chlorhexidine gluconate SOLUTION TOPICAL 20110303 NDA NDA019258 Ecolab Inc. CHLORHEXIDINE GLUCONATE 40 mg/mL N 20181231 47593-469_d842a1f1-2c24-4918-b86c-8bc4f55ad88c 47593-469 HUMAN OTC DRUG Ecolab Triclosan SOLUTION TOPICAL 20110124 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-470_df609fa2-119a-4e14-906b-0cd167ab4666 47593-470 HUMAN OTC DRUG Foodservice Foam Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20101208 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE .1 mg/100mL N 20181231 47593-471_c6389eac-096b-4ba5-8d8f-efd222c97aab 47593-471 HUMAN OTC DRUG Ecolab Triclosan SOLUTION TOPICAL 20110211 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-472_f61cac4a-6c71-433b-a30c-dcd6db07c899 47593-472 HUMAN OTC DRUG Ecolab Alcohol SOLUTION TOPICAL 20101116 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 62 mL/100mL N 20181231 47593-473_179d92c5-748d-4c6e-838e-5b039fdaeccf 47593-473 HUMAN OTC DRUG Pureforce Alcohol SOLUTION TOPICAL 20110427 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 60 mL/100mL N 20181231 47593-474_50a0c55c-8c46-4783-98d5-c5cc489c523c 47593-474 HUMAN OTC DRUG Facilipro Waterless Hand Rinse Alcohol SOLUTION TOPICAL 20110418 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 70 mL/100mL N 20181231 47593-476_969ea6f6-ce84-4a51-b353-877404a39272 47593-476 HUMAN OTC DRUG Proforce Commercial Products triclosan SOLUTION TOPICAL 20110325 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mL/100mL N 20181231 47593-477_13907b41-85da-49f6-8ecb-903b975256e4 47593-477 HUMAN OTC DRUG Sysco Reliance Chloroxylenol SOLUTION TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL .5 mg/100mL N 20181231 47593-478_c54919a0-551e-4ae2-a2cc-beeec2cd6621 47593-478 HUMAN OTC DRUG Reliance Hand Saniziter Benzalkonium chloride SOLUTION TOPICAL 20110330 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE .1 mg/100mL N 20191231 47593-479_63cc68d1-4d28-4059-8f28-fd0d3ef45c4c 47593-479 HUMAN OTC DRUG Sysco chloroxylenol SOLUTION TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL .5 mg/100mL N 20191231 47593-480_a242ba91-73b0-4ae7-8fb6-40515df076d5 47593-480 HUMAN OTC DRUG Sysco Reliance alcohol SOLUTION TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 60 mL/100mL N 20191231 47593-483_cd8cce3a-015f-4432-9088-7c5c4a0ded23 47593-483 HUMAN OTC DRUG ECOLAB Povidone Iodine SOLUTION TOPICAL 20110624 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. POVIDONE-IODINE 7.5 mL/100mL N 20181231 47593-484_e64b80ca-065e-4d94-91fc-de557ff66897 47593-484 HUMAN OTC DRUG ECOLAB Povidone Iodine SOLUTION TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. POVIDONE-IODINE 7.5 mL/100mL N 20181231 47593-485_e46e727b-43bc-4475-9193-35589e05b1e8 47593-485 HUMAN OTC DRUG Ecolab Triclosan SOLUTION TOPICAL 20130425 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 10 mg/mL N 20191231 47593-487_18ee3b9d-6a3d-4939-a31e-63d8f2dfb6a3 47593-487 HUMAN OTC DRUG Ecolab Alcohol SOLUTION TOPICAL 20121128 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 589.4 mg/mL N 20181231 47593-488_4eeda622-8213-457e-b9c0-a95fa9253c5b 47593-488 HUMAN OTC DRUG Ecolab Alcohol SOLUTION TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 540.02 mg/mL N 20181231 47593-489_38a4f4a4-e3ab-418f-8a14-8439c0bc6303 47593-489 HUMAN OTC DRUG Ecolab Ethyl Alcohol SOLUTION TOPICAL 20131207 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 620 mg/mL N 20181231 47593-490_848fb5cf-13b3-421c-b2b6-58cbb12e97f6 47593-490 HUMAN OTC DRUG Quik-Care Ethyl Alcohol SOLUTION TOPICAL 20121010 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 54.7 g/100g N 20181231 47593-491_5bbbe1bd-ba67-4f72-afc3-c45a01280df4 47593-491 HUMAN OTC DRUG Quik-Care Ethyl Alcohol SOLUTION TOPICAL 20130619 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 539.71 mg/mL N 20181231 47593-492_576a5610-0366-4a59-b1ce-02e7c8c412e9 47593-492 HUMAN OTC DRUG Ecolab Benzalkonium Chloride SOLUTION TOPICAL 20111011 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 4.7 mg/mL N 20181231 47593-493_58d4bdee-4729-4d38-bd34-f0f3c4978036 47593-493 HUMAN OTC DRUG EcoCare 275 Chloroxylenol SOLUTION TOPICAL 20160622 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 100 mg/mL N 20181231 47593-495_679ddc51-1d0c-4e2f-99e0-3f4d4e875440 47593-495 HUMAN OTC DRUG PureForce Chloroxylenol SOLUTION TOPICAL 20120823 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5.25 mg/mL N 20181231 47593-496_74100f82-1845-46f4-a36e-35c1b569531b 47593-496 HUMAN OTC DRUG PureForce Benzalkonium SOLUTION TOPICAL 20120823 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 47593-497_a6bb7f93-da60-44d5-9cad-27023fdd0722 47593-497 HUMAN OTC DRUG PureForce Chloroxylenol SOLUTION TOPICAL 20120727 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5.2 mg/mL N 20181231 47593-498_e753edc7-1588-4ea0-8ddb-93842ae998c3 47593-498 HUMAN OTC DRUG PureForce Alcohol SOLUTION TOPICAL 20120823 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 534 mg/mL N 20181231 47593-499_436a663a-83f3-483a-bc77-7acdbc767b61 47593-499 HUMAN OTC DRUG Clean Strike Triclosan SOLUTION TOPICAL 20120619 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3.06 mg/mL N 20181231 47593-500_4ed8aa4c-8320-4c2e-bc71-1af6ab4bf6b5 47593-500 HUMAN OTC DRUG Quik-Care Alcohol SOLUTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 539.4 mg/mL N 20181231 47593-501_0a10d21f-e33f-41ff-bb27-d8b09617e33d 47593-501 HUMAN OTC DRUG Ecolab Chloroxylenol SOLUTION TOPICAL 20121024 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5.2 mg/mL N 20181231 47593-502_5b2a344c-c2a9-49f9-b39a-e1902a35dea7 47593-502 HUMAN OTC DRUG Ecolab Alcohol SOLUTION TOPICAL 20130326 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 598.5 mg/mL N 20181231 47593-503_b0c94276-c4f5-42b4-b2b3-01a9e9a83eb0 47593-503 HUMAN OTC DRUG Ecolab Inc. Chloroxylenol LIQUID TOPICAL 20131027 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5 mg/mL N 20181231 47593-504_2801768f-0b36-4228-b623-ebdb0b0cf410 47593-504 HUMAN OTC DRUG Pure Force Benzalkonium chloride LIQUID TOPICAL 20131028 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 47593-505_b440a068-1ee5-4da7-a12e-e679978c59d4 47593-505 HUMAN OTC DRUG Ecolab Chloroxylenol LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5 mg/mL N 20181231 47593-506_d638976a-5bf4-49f5-aca1-38e8161cf8b9 47593-506 HUMAN OTC DRUG Ecolab Chloroxylenol LIQUID TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 10 mg/mL N 20181231 47593-507_1c2fd22a-6ece-4705-9b02-9e1c026c1aff 47593-507 HUMAN OTC DRUG Ecolab Alcohol LIQUID TOPICAL 20131031 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 60 mL/100mL N 20181231 47593-508_ab1dff0b-de91-4c90-9295-acb996e6b4df 47593-508 HUMAN OTC DRUG Ecolab Facilipro Alcohol LIQUID TOPICAL 20140202 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 60 mL/100mL N 20181231 47593-509_41407093-f49e-4a66-9e9c-1910a36d95a0 47593-509 HUMAN OTC DRUG Ecolab Alcohol LIQUID TOPICAL 20140305 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 700 mg/mL N 20181231 47593-510_371c5e78-cff1-423e-a33f-04c305fcaa1c 47593-510 HUMAN OTC DRUG Ecolab Triclosan SOLUTION TOPICAL 20150803 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-511_17bd5848-4d64-4cf0-9bdb-b86199f8fc8d 47593-511 HUMAN OTC DRUG Ecolab Inc. Benzalkonium chloride SOLUTION TOPICAL 20150226 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 8.9 mg/mL N 20181231 47593-512_4e2832f4-e071-434c-af34-ef46d448b850 47593-512 HUMAN OTC DRUG Ecolab Inc. Benzalkonium chloride SOLUTION TOPICAL 20150302 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 8.9 mg/mL N 20181231 47593-513_56a10663-0bd9-4f4b-b674-78aca72f5942 47593-513 HUMAN OTC DRUG Ecolab Inc. Benzalkonium chloride SOLUTION TOPICAL 20150226 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 8.9 mg/mL N 20181231 47593-514_a0b505db-4566-476c-bc1d-9925f9b8d982 47593-514 HUMAN OTC DRUG Ecolab Inc. Benzalkonium chloride SOLUTION TOPICAL 20150302 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 8.9 mg/mL N 20181231 47593-515_efb0f95d-62e7-4e00-8569-4babd15b4a50 47593-515 HUMAN OTC DRUG Ecolab Clean Force Chloroxylenol SOLUTION TOPICAL 20150803 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5 mg/mL N 20181231 47593-521_88acbf7d-b325-427b-a829-29527c9e7b53 47593-521 HUMAN OTC DRUG Ecolab Benzalkonium chloride SOLUTION TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5.5 mg/mL N 20181231 47593-532_7396b431-b39b-4f35-8de8-d2454fb62be0 47593-532 HUMAN OTC DRUG Ecolab Benzalkonium chloride SOLUTION TOPICAL 20160428 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5.5 mg/mL N 20181231 47593-543_f5328ac8-76bf-41e4-a1b5-ca1b017be1b3 47593-543 HUMAN OTC DRUG Ecolab Benzalkonium Chloride SOLUTION TOPICAL 20150812 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5 mg/mL N 20181231 47593-546_74941d3f-e829-4a30-999a-8d054fa1a258 47593-546 HUMAN OTC DRUG Ecolab Triclosan SOLUTION TOPICAL 20150803 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-561_708b6e7e-080c-4513-b0ca-ef22f311b164 47593-561 HUMAN OTC DRUG Keystone Benzalkonium Chloride SOLUTION TOPICAL 20161221 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5 mg/mL N 20181231 47593-562_dfce15d3-585c-4e88-bc96-202502aca450 47593-562 HUMAN OTC DRUG Swisher Triclosan SOLUTION TOPICAL 20160202 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-563_cc357665-9384-44f7-9420-28862a75a2ca 47593-563 HUMAN OTC DRUG Facilipro Ethyl Alcohol SOLUTION TOPICAL 20101203 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 620 mg/mL N 20181231 47593-564_72656096-85bb-46c6-81f9-f321b0b05d0a 47593-564 HUMAN OTC DRUG Pureforce Triclosan SOLUTION TOPICAL 20110303 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN .3 mg/100mL N 20181231 47593-565_ddd6080b-d3c4-4ca2-846d-6d064104c29b 47593-565 HUMAN OTC DRUG Facilipro Benzalkonium chloride SOLUTION TOPICAL 20160329 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5.5 mg/mL N 20181231 47593-566_cef97db3-189a-46d5-8a1e-995b29c18063 47593-566 HUMAN OTC DRUG Facilipro Benzalkonium Chloride SOLUTION TOPICAL 20160523 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5 mg/mL N 20181231 47593-567_cab97d9c-6b1b-48e4-bfe7-a76130f61df3 47593-567 HUMAN OTC DRUG PureForce Benzalkonium chloride SOLUTION TOPICAL 20160614 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 47593-568_62990c82-1c11-4548-a905-620843ec961b 47593-568 HUMAN OTC DRUG PureForce Benzalkonium Chloride SOLUTION TOPICAL 20160726 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5 mg/mL N 20181231 47593-570_9b442df2-8499-4c6d-bb52-a2fc60d8c961 47593-570 HUMAN OTC DRUG PureForce Alcohol SOLUTION TOPICAL 20160727 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. ALCOHOL 534 mg/mL N 20181231 47593-571_2d862590-3a93-432e-9ee6-657d45861a88 47593-571 HUMAN OTC DRUG PureForce Chloroxylenol SOLUTION TOPICAL 20160727 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5 mg/mL N 20181231 47593-572_261bf148-f52f-4346-8b03-3c71aa3cc284 47593-572 HUMAN OTC DRUG Members Mark Benzalkonium Chloride SOLUTION TOPICAL 20160729 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5 mg/mL N 20181231 47593-573_0cd5fcd2-1f6e-40c4-801e-ab1c79183dea 47593-573 HUMAN OTC DRUG Members Mark Chloroxylenol SOLUTION TOPICAL 20160728 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. CHLOROXYLENOL 5 mg/mL N 20181231 47593-575_8aff7cbd-b1d2-4522-995f-525af4872fa1 47593-575 HUMAN OTC DRUG Ecolab Benzalkonium chloride SOLUTION TOPICAL 20170525 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5 mg/mL N 20181231 47593-576_7910028e-82ac-4f2b-84b1-229c55922336 47593-576 HUMAN OTC DRUG Swisher Benzalkonium chloride SOLUTION TOPICAL 20160908 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 47593-578_40ccf667-2dd6-4fd7-ab44-e440f099a3d8 47593-578 HUMAN OTC DRUG ProClean Triclosan SOLUTION TOPICAL 20160809 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. TRICLOSAN 3 mg/mL N 20181231 47593-579_690d9054-a64e-4340-840e-77821758473e 47593-579 HUMAN OTC DRUG ProClean Benzalkonium Chloride SOLUTION TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5 mg/mL N 20181231 47593-581_eaeec07e-a48b-4cae-9ec9-90af541015c0 47593-581 HUMAN OTC DRUG Ecolab Benzalkonium chloride SOLUTION TOPICAL 20170518 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 47593-582_a4d38793-d365-44b2-9eea-4fec8ff3067e 47593-582 HUMAN OTC DRUG Equi-Mild Benzalkonium Chloride SOLUTION TOPICAL 20170622 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5 mg/mL N 20181231 47593-584_cf82c891-2f55-4894-b7d1-a1240c9b1ee6 47593-584 HUMAN OTC DRUG Clean Force Benzalkonium Chloride SOLUTION TOPICAL 20170630 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5 mg/mL N 20181231 47593-585_fa8fc8ae-6f58-4ee1-8d23-d62d45930b8d 47593-585 HUMAN OTC DRUG Equi-Stat Benzalkonium chloride SOLUTION TOPICAL 20171220 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 5 mg/mL N 20181231 47593-586_ba6199bd-d719-49b3-aab9-8d1c8e425f3a 47593-586 HUMAN OTC DRUG Clean Force Benzalkonium chloride LIQUID TOPICAL 20171220 OTC MONOGRAPH NOT FINAL part333E Ecolab Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 47632-0003_01871d24-8aaf-4980-9ce5-817e9b3050bc 47632-0003 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19881215 NDA NDA205766 O.E. Meyer Company NITROGEN 99 L/100L N 20181231 47632-0025_523a3688-de53-4154-af26-a63e9143f3d6 47632-0025 HUMAN PRESCRIPTION DRUG AIR COMPRESSED AIR COMPRESSED GAS RESPIRATORY (INHALATION) 19881215 NDA NDA205765 O.E. Meyer Company OXYGEN 20 L/100L N 20191231 47632-0029_20aeba25-8c35-4921-8014-c33688c0b493 47632-0029 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19881215 NDA NDA205767 O.E. Meyer Company OXYGEN 99 L/100L N 20181231 47632-0030_20aeba25-8c35-4921-8014-c33688c0b493 47632-0030 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19881215 NDA NDA205767 O.E. Meyer Company OXYGEN 99 L/100L N 20181231 47649-0101_78a7af9d-f2b0-467d-8f5f-a0f32a327ff9 47649-0101 HUMAN OTC DRUG Dr.Whitiss 10% CARBAMIDE PEROXIDE GEL, DENTIFRICE DENTAL 20150607 OTC MONOGRAPH NOT FINAL part356 Nibec Co., Ltd CARBAMIDE PEROXIDE 10 g/100g N 20181231 47649-1101_45859a43-0916-45c7-a813-038ff8383163 47649-1101 HUMAN OTC DRUG Dr.Whitiss 15% CARBAMIDE PEROXIDE GEL, DENTIFRICE DENTAL 20150607 OTC MONOGRAPH NOT FINAL part356 Nibec Co., Ltd CARBAMIDE PEROXIDE 15 g/100g N 20181231 47649-1201_e1b98f79-af39-4c58-8136-1add99ba857a 47649-1201 HUMAN OTC DRUG Dr.Whitiss 20% CARBAMIDE PEROXIDE GEL, DENTIFRICE DENTAL 20150607 OTC MONOGRAPH NOT FINAL part356 Nibec Co., Ltd CARBAMIDE PEROXIDE 20 g/100g N 20181231 47649-1301_9ebb574d-f30d-404a-9046-42299a93e01a 47649-1301 HUMAN OTC DRUG Dr.Whitiss 35% CARBAMIDE PEROXIDE GEL, DENTIFRICE DENTAL 20150811 OTC MONOGRAPH NOT FINAL part356 Nibec Co., Ltd CARBAMIDE PEROXIDE 35 g/100g N 20181231 47649-9001_5f0112bb-31bf-d5c1-e053-2a91aa0a44d5 47649-9001 HUMAN OTC DRUG Dr. Whitiss (8.3%) CARBAMIDE PEROXIDE GEL, DENTIFRICE DENTAL 20140711 OTC MONOGRAPH NOT FINAL part356 Nibec Co., Ltd CARBAMIDE PEROXIDE .083 g/g N 20181231 47682-001_439023f1-5a8a-3160-e054-00144ff88e88 47682-001 HUMAN OTC DRUG Green Guard Advanced Sinus Relief ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 47682-002_438f372b-0afd-005d-e054-00144ff88e88 47682-002 HUMAN OTC DRUG Green Guard Advanced Sinus Relief ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 47682-003_168853ed-4039-2f02-e054-00144ff88e88 47682-003 HUMAN OTC DRUG Green Guard Pain and Ache Relief ACETAMINOPHEN, ASPIRIN, SALICYLAMIDE and CAFFEINE TABLET ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; ASPIRIN; SALICYLAMIDE; CAFFEINE 110; 162; 152; 32.4 mg/1; mg/1; mg/1; mg/1 N 20181231 47682-006_494c56d5-1b58-6c52-e054-00144ff8d46c 47682-006 HUMAN OTC DRUG Green Guard Cough and Cold Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 47682-007_0fc6bd8a-1552-2c34-e054-00144ff88e88 47682-007 HUMAN OTC DRUG Green Guard Stomach Relief calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 N 20181231 47682-008_04aa0e8d-8e96-4b70-9d95-0d8caeb5bfb5 47682-008 HUMAN OTC DRUG Green Guard Stomach Relief calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 N 20181231 47682-009_da360d0c-4587-433e-aefa-f90a813e0f9b 47682-009 HUMAN OTC DRUG Green Guard Maximum Non-Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 N 20181231 47682-010_0d190c2e-84de-67e8-e054-00144ff88e88 47682-010 HUMAN OTC DRUG Green Guard Maximum Non-Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 N 20181231 47682-016_4f2e3572-ca18-24c9-e054-00144ff8d46c 47682-016 HUMAN OTC DRUG Green Guard PMS Relief ACETAMINOPHEN, PAMABROM TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; PAMABROM 325; 25 mg/1; mg/1 N 20181231 47682-017_147bfae8-46c7-036c-e054-00144ff8d46c 47682-017 HUMAN OTC DRUG Green Guard Allergy 2 Relief PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 N 20181231 47682-018_0cb25f1b-6f31-73ed-e054-00144ff88e88 47682-018 HUMAN OTC DRUG Green Guard Cough Drop Relief Menthol LOZENGE ORAL 20111101 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation MENTHOL 7.6 mg/1 N 20181231 47682-019_562e3eaf-3fcd-4135-e054-00144ff8d46c 47682-019 HUMAN OTC DRUG Green Guard Sterile Alcohol Pads Isopropyl Alcohol LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 47682-030_5743634b-f32a-5fec-e053-2991aa0a751d 47682-030 HUMAN OTC DRUG Medi-First Plus Antiseptic Wipes Benzalkonium chloride SWAB TOPICAL 20170821 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 47682-031_52a0501f-5859-562c-e054-00144ff8d46c 47682-031 HUMAN OTC DRUG Medi-First Plus Alcohol Wipes 70% Isopropyl Alcohol SWAB TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation ISOPROPYL ALCOHOL .7 mL/1 N 20181231 47682-035_570baa70-e51a-328b-e054-00144ff8d46c 47682-035 HUMAN OTC DRUG Green Guard Sterile Alcohol Wipes Isopropyl alcohol 70% SWAB TOPICAL 20170818 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 47682-045_574970ca-cfc2-76d8-e053-2991aa0ac146 47682-045 HUMAN OTC DRUG Green Guard Antiseptic Wipes Benzalkonium chloride SWAB TOPICAL 20170821 OTC MONOGRAPH NOT FINAL part333A Uniforst First Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 47682-050_0cb25f1b-6f4c-73ed-e054-00144ff88e88 47682-050 HUMAN OTC DRUG MEDIQUE Medikoff Drops MENTHOL LOZENGE ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation MENTHOL 7.6 mg/1 N 20181231 47682-055_574970ca-cfc2-76d8-e053-2991aa0ac146 47682-055 HUMAN OTC DRUG Green Guard Antideptic Wipes Benzalkonium chloride SWAB TOPICAL 20170821 OTC MONOGRAPH NOT FINAL part333A Uniforst First Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 47682-073_178ed903-bf54-5a4a-e054-00144ff88e88 47682-073 HUMAN OTC DRUG MEDIQUE Back Pain Off Magnesium Salicylate/Acetaminophen/Caffeine TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation MAGNESIUM SALICYLATE; CAFFEINE; ACETAMINOPHEN 290; 50; 250 mg/1; mg/1; mg/1 N 20181231 47682-088_178c38cb-b58a-6918-e054-00144ff8d46c 47682-088 HUMAN OTC DRUG Medique Alcalak calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 N 20181231 47682-089_178c38cb-b58a-6918-e054-00144ff8d46c 47682-089 HUMAN OTC DRUG Medi First Antacid calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 N 20181231 47682-092_178c38cb-b58a-6918-e054-00144ff8d46c 47682-092 HUMAN OTC DRUG Medi First Plus Antacid calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 N 20181231 47682-097_3ff06e43-163d-6013-e054-00144ff8d46c 47682-097 HUMAN OTC DRUG MEDIQUE Aspirin Aspirin TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ASPIRIN 325 mg/1 N 20181231 47682-098_3ff06e43-163d-6013-e054-00144ff8d46c 47682-098 HUMAN OTC DRUG MEDI-FIRST Aspirin Aspirin TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ASPIRIN 325 mg/1 N 20181231 47682-099_3ff06e43-163d-6013-e054-00144ff8d46c 47682-099 HUMAN OTC DRUG Medi First Plus Aspirin Aspirin TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ASPIRIN 325 mg/1 N 20181231 47682-110_44f44824-7edb-4f9c-92db-65542682e618 47682-110 HUMAN OTC DRUG Medique Sugar Free Medikoff Drops Menthol LOZENGE ORAL 20111101 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation MENTHOL 5.8 mg/1 N 20181231 47682-112_42775923-a312-6149-e054-00144ff8d46c 47682-112 HUMAN OTC DRUG MEDIQUE APAP Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 N 20181231 47682-113_42775923-a312-6149-e054-00144ff8d46c 47682-113 HUMAN OTC DRUG MEDI-FIRST Non-Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 N 20181231 47682-114_42775923-a312-6149-e054-00144ff8d46c 47682-114 HUMAN OTC DRUG Medi First Plus Non-Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 N 20181231 47682-115_42775923-a312-6149-e054-00144ff8d46c 47682-115 HUMAN OTC DRUG Dover Aminophen Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 N 20181231 47682-120_4f2fd4c1-b699-58ac-e054-00144ff88e88 47682-120 HUMAN OTC DRUG Medique Medicidin D ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 47682-125_415b168c-126a-2777-e054-00144ff88e88 47682-125 HUMAN OTC DRUG MEDIQUE APAP Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 N 20181231 47682-126_415b168c-126a-2777-e054-00144ff88e88 47682-126 HUMAN OTC DRUG MEDI-FIRST Non-Aspirin Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 N 20181231 47682-127_415b168c-126a-2777-e054-00144ff88e88 47682-127 HUMAN OTC DRUG Medi First Plus Non-Aspirin Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 N 20181231 47682-135_178dded8-40ad-2e75-e054-00144ff88e88 47682-135 HUMAN OTC DRUG Medique Medi Seltzer aspirin, citric acid, sodium bicarbonate TABLET, EFFERVESCENT ORAL 20081230 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 N 20181231 47682-138_494a71e6-2d63-121e-e054-00144ff8d46c 47682-138 HUMAN OTC DRUG Medique Decorel Forte Plus ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 47682-139_494a71e6-2d63-121e-e054-00144ff8d46c 47682-139 HUMAN OTC DRUG Medi-First Cold Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 47682-145_4159c76c-deef-0f00-e054-00144ff8d46c 47682-145 HUMAN OTC DRUG MEDIQUE APAP Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 N 20181231 47682-146_42ec5821-7a91-5974-e054-00144ff8d46c 47682-146 HUMAN OTC DRUG Medi First Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 47682-148_42ec5821-7a91-5974-e054-00144ff8d46c 47682-148 HUMAN OTC DRUG Otis Clapp Mygrex ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 47682-158_42ec5821-7a91-5974-e054-00144ff8d46c 47682-158 HUMAN OTC DRUG Medi First Plus Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 47682-159_494a71e6-2d63-121e-e054-00144ff8d46c 47682-159 HUMAN OTC DRUG Medi-First Plus Cold Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 47682-161_429eb000-4086-559d-e054-00144ff88e88 47682-161 HUMAN OTC DRUG Medique Medi-Phenyl PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 N 20181231 47682-162_429eb000-4086-559d-e054-00144ff88e88 47682-162 HUMAN OTC DRUG Dover Sudanyl PE PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 N 20181231 47682-164_15e82e14-ecce-0851-e054-00144ff88e88 47682-164 HUMAN OTC DRUG Medique Chlorphen CHLORPHENIRAMINE MALEATE TABLET ORAL 20111001 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 47682-165_184242fa-91c8-53b0-e054-00144ff88e88 47682-165 HUMAN OTC DRUG MEDIQUE DIOTAME bismuth subsalicylate SUSPENSION ORAL 20110405 OTC MONOGRAPH FINAL part335 Unique First Aid Corporation BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 47682-167_429baaad-7550-3e82-e054-00144ff8d46c 47682-167 HUMAN OTC DRUG Medique Diphen DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120101 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 47682-168_402937f5-8026-165e-e054-00144ff8d46c 47682-168 HUMAN OTC DRUG Medique CCP Caffeine Free ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20110801 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 47682-170_429f93a5-6939-1171-e054-00144ff88e88 47682-170 HUMAN OTC DRUG Medi-First Sinus Decongestant PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120102 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 47682-175_415c9a90-a897-2c4c-e054-00144ff8d46c 47682-175 HUMAN OTC DRUG MEDIQUE APAP Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 N 20181231 47682-184_429baaad-7550-3e82-e054-00144ff8d46c 47682-184 HUMAN OTC DRUG Medique Diphen DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120101 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 47682-189_4f30bfb6-8905-2b2d-e054-00144ff8d46c 47682-189 HUMAN OTC DRUG Medique Medicidin D ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120319 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 47682-190_4f30bfb6-8905-2b2d-e054-00144ff8d46c 47682-190 HUMAN OTC DRUG Otis Clapp Valihist ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120319 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 47682-197_603cf1a5-0697-b45a-e053-2a91aa0a46ab 47682-197 HUMAN OTC DRUG Medi-First First Aid Eye Wash Water SOLUTION OPHTHALMIC 20151001 OTC MONOGRAPH FINAL part349 Unifirst First Aid Corporation WATER .983 mg/mL N 20181231 47682-198_603cf1a5-0697-b45a-e053-2a91aa0a46ab 47682-198 HUMAN OTC DRUG Medi-First First Aid Eye Wash Water SOLUTION OPHTHALMIC 20111202 OTC MONOGRAPH FINAL part349 Unifirst First Aid Corporation WATER .983 mg/mL N 20181231 47682-199_1a48c89e-9f53-6145-e054-00144ff88e88 47682-199 HUMAN OTC DRUG Medi-First Eyewash Water SOLUTION OPHTHALMIC 20140501 OTC MONOGRAPH FINAL part349 Unifirst First Aid Corporation WATER .929 g/946mL N 20181231 47682-200_429c83c0-a8f1-5495-e054-00144ff8d46c 47682-200 HUMAN OTC DRUG MEDIQUE Diamode Loperamide Hydrochloride TABLET ORAL 20081230 ANDA ANDA074091 Unifirst First Aid Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 47682-201_d5880d7b-898b-44c1-a861-16ba7dbc5564 47682-201 HUMAN OTC DRUG Medique Alcalak calcium carbonate TABLET, CHEWABLE ORAL 20140615 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 N 20181231 47682-203_429e98d2-6da6-559f-e054-00144ff88e88 47682-203 HUMAN OTC DRUG MEDIQUE Loradamed Loratadine TABLET, FILM COATED ORAL 20081230 ANDA ANDA076134 Unifirst First Aid Corporation LORATADINE 10 mg/1 N 20181231 47682-210_42af19b8-5ea2-16b4-e054-00144ff88e88 47682-210 HUMAN OTC DRUG Medique Diotame BISMUTH SUBSALICYLATE TABLET, CHEWABLE ORAL 20140401 OTC MONOGRAPH FINAL part335 Unifirst First Aid Corporation BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 47682-211_c065512c-2400-417b-94a8-f870a30721c4 47682-211 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation HYDROCORTISONE 10 mg/g N 20181231 47682-212_5743634b-f32a-5fec-e053-2991aa0a751d 47682-212 HUMAN OTC DRUG Medi-First Antiseptic Wipes Benzalkonium chloride SWAB TOPICAL 20170821 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation BENZALKONIUM CHLORIDE 1.33 mg/mL N 20181231 47682-213_20e75974-679b-7342-e054-00144ff8d46c 47682-213 HUMAN OTC DRUG Medi-first Burn First Aid benzethonium chloride, benzocaine, and menthol AEROSOL, SPRAY TOPICAL 20130405 20180501 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZOCAINE; BENZETHONIUM CHLORIDE; MENTHOL 8500; 170; 281 mg/85g; mg/85g; mg/85g N 20181231 47682-214_5baf4c11-c8ff-f75b-e053-2a91aa0abc80 47682-214 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20120222 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 47682-215_579673be-9de1-b137-e053-2991aa0ac2fc 47682-215 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation BENZALKONIUM CHLORIDE .0013 g/mL N 20181231 47682-217_18b6eda0-0d24-3678-e054-00144ff8d46c 47682-217 HUMAN OTC DRUG Medique Guaicon DMS Guaifenesin, Dextromethorphan Hbr SYRUP ORAL 20110405 OTC MONOGRAPH FINAL part341 UNIFIRST FIRST AID CORPORATION GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 47682-221_56d04cbc-ce5e-2066-e054-00144ff88e88 47682-221 HUMAN OTC DRUG Medi-First Sterile Alcohol Pads Isopropyl Alcohol LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 47682-222_52a0501f-5859-562c-e054-00144ff8d46c 47682-222 HUMAN OTC DRUG Medi-First Alcohol Wipes Isopropyl Alcohol SWAB TOPICAL 20161107 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation ISOPROPYL ALCOHOL .7 mL/1 N 20181231 47682-223_3f2863d0-b8d9-5ca9-e054-00144ff88e88 47682-223 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20130425 OTC MONOGRAPH FINAL part333B Unifirst First Aid Corporation NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 5000; 400 mg/g; [USP'U]/g; [USP'U]/g N 20181231 47682-225_331eb05d-6b64-0d8a-e054-00144ff88e88 47682-225 HUMAN OTC DRUG MediFirst Burn Lidocaine Hydrochloride SPRAY TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation LIDOCAINE HYDROCHLORIDE 20 g/L N 20181231 47682-226_a670852b-93b4-4857-b2b2-9d795ed160b6 47682-226 HUMAN OTC DRUG Blood Clotting First Aid benzethonium chloride and lidocaine AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation LIDOCAINE; BENZETHONIUM CHLORIDE 3400; 170 mg/85g; mg/85g N 20181231 47682-228_4f55d322-d073-5edc-e054-00144ff88e88 47682-228 HUMAN OTC DRUG Medique Pain Off ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ASPIRIN; CAFFEINE; ACETAMINOPHEN 250; 65; 250 mg/1; mg/1; mg/1 N 20181231 47682-229_01719e41-a8b4-4b4d-b67a-d5cb13ea9681 47682-229 HUMAN OTC DRUG Antifungal tolnaftate CREAM TOPICAL 20020630 OTC MONOGRAPH FINAL part333C Unifirst First Aid Corporation TOLNAFTATE 10 mg/g N 20181231 47682-231_331ef380-f4f4-16b3-e054-00144ff88e88 47682-231 HUMAN OTC DRUG Antiseptic alcohol, lidocaine hydrochloride LIQUID TOPICAL 20120306 20180903 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation ALCOHOL; LIDOCAINE HYDROCHLORIDE 500; 20 mg/g; mg/g N 20181231 47682-232_5d57f44c-f1a2-b9f7-e053-2991aa0aec18 47682-232 HUMAN OTC DRUG Medi-First Sting Relief Wipes Benzocaine, 6% SWAB TOPICAL 20160615 OTC MONOGRAPH FINAL part348 Unifirst First Aid Corporation BENZOCAINE 60 mg/mL N 20181231 47682-233_5d57f44c-f1a2-b9f7-e053-2991aa0aec18 47682-233 HUMAN OTC DRUG Medi-First Sting Relief Wipes Benzocaine SWAB TOPICAL 20171017 OTC MONOGRAPH FINAL part348 Unifirst First Aid Corporation BENZOCAINE 60 mg/mL N 20181231 47682-237_42b0ae8a-1c96-5626-e054-00144ff8d46c 47682-237 HUMAN OTC DRUG Medique Mediproxen NAPROXEN SODIUM TABLET, FILM COATED ORAL 20081230 ANDA ANDA079096 Unifirst First Aid Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 47682-244_05692b4f-b554-4099-adb8-784960255b04 47682-244 HUMAN OTC DRUG MediFirst Antiseptic benzalkonium chloride SPRAY TOPICAL 20090729 20190510 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation BENZALKONIUM CHLORIDE 1.3 g/L N 20181231 47682-245_984482b9-48b4-466e-9059-827da4313558 47682-245 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20160510 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation BENZALKONIUM CHLORIDE 1.3 g/L N 20181231 47682-257_331e575e-ae88-0249-e054-00144ff88e88 47682-257 HUMAN OTC DRUG MediFirst Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation HYDROGEN PEROXIDE 43.275 g/L N 20181231 47682-260_57ea7f8a-2694-367e-e053-2a91aa0a93e1 47682-260 HUMAN OTC DRUG Burn with Lidocaine Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g N 20181231 47682-261_57068e32-83a5-5495-e054-00144ff8d46c 47682-261 HUMAN OTC DRUG Medi-First First Aid Burn Cream Lidocaine CREAM TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE .5; .13 g/100g; g/100g N 20181231 47682-267_570a7564-2232-6009-e054-00144ff8d46c 47682-267 HUMAN OTC DRUG Medi-First PVP Iodine Wipes Povidone iodine 10% SWAB TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part333A Unifirst-First Aid POVIDONE-IODINE 10 mg/mL N 20181231 47682-268_331dd922-8ab4-0ff6-e054-00144ff8d46c 47682-268 HUMAN OTC DRUG MediFirst Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation ISOPROPYL ALCOHOL 550.2 g/L N 20181231 47682-279_5df7ffc8-ecab-0b30-e053-2991aa0a49b7 47682-279 HUMAN OTC DRUG Medi-first Antiseptic First Aid benzocaine and benzethonium chloride AEROSOL, SPRAY TOPICAL 20130405 20180501 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZETHONIUM CHLORIDE; BENZOCAINE 170; 8500 mg/85g; mg/85g N 20181231 47682-285_5a43b329-7db5-b479-e053-2991aa0a7d83 47682-285 HUMAN OTC DRUG Medique Ban-acid Maximum Strength 750 calcium carbonate TABLET, CHEWABLE ORAL 20140701 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 47682-300_3500357c-b134-4aba-8bf3-3435cb2575bc 47682-300 HUMAN OTC DRUG Green Guard Super Stat Blood Clotting First Aid benzethonium chloride and lidocaine AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation LIDOCAINE; BENZETHONIUM CHLORIDE 3400; 170 mg/85g; mg/85g N 20181231 47682-301_5df4a067-3a4f-5576-e053-2991aa0a2ec1 47682-301 HUMAN OTC DRUG Green Guard Antiseptic First Aid benzocaine and benzethonium chloride AEROSOL, SPRAY TOPICAL 20130405 20180402 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZOCAINE; BENZETHONIUM CHLORIDE 8500; 170 mg/85g; mg/85g N 20181231 47682-302_576ac99d-688e-372a-e053-2991aa0aa787 47682-302 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20120222 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation BENZALKONIUM CHLORIDE 1.3 mg/g N 20181231 47682-303_4159c76c-deef-0f00-e054-00144ff8d46c 47682-303 HUMAN OTC DRUG Dover Aminophen Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 N 20181231 47682-304_331dd6f1-f511-5ff2-e054-00144ff88e88 47682-304 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20131210 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation HYDROGEN PEROXIDE 30 mL/L N 20181231 47682-306_5d51dab1-2857-e33b-e053-2a91aa0ac7ff 47682-306 HUMAN OTC DRUG Antiseptic benzalkonium chloride SPRAY TOPICAL 20150610 20190516 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation BENZALKONIUM CHLORIDE 1.3 g/L N 20181231 47682-307_4d871c69-da97-7004-e054-00144ff88e88 47682-307 HUMAN OTC DRUG Dover Coldonyl ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 20180903 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 100; 5 mg/1; mg/1; mg/1 N 20181231 47682-308_f8edfbfd-8b63-4037-a783-7e1f58d917df 47682-308 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SPRAY TOPICAL 20150610 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation LIDOCAINE HYDROCHLORIDE 20 g/L N 20181231 47682-310_57f985e3-952e-477f-e053-2991aa0a61c9 47682-310 HUMAN OTC DRUG Green Guard Derma-Caine Lidocaine CREAM TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE .5; .13 g/100g; g/100g N 20181231 47682-313_5df59b46-527f-53dc-e053-2991aa0a3fc2 47682-313 HUMAN OTC DRUG Green Guard Hydrogen Peroxide First Aid hydrogen peroxide SPRAY, METERED TOPICAL 20130405 20180601 OTC MONOGRAPH NOT FINAL part356 Unifirst First Aid Corporation HYDROGEN PEROXIDE 3.54 mL/119mL N 20181231 47682-316_5d521272-df07-7940-e053-2a91aa0a9b2f 47682-316 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation BENZALKONIUM CHLORIDE 1.3 g/L N 20181231 47682-392_53333f93-83a8-73ba-e054-00144ff88e88 47682-392 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20130412 OTC MONOGRAPH FINAL part333B Unifirst First Aid Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 47682-397_5333273f-0917-6c84-e054-00144ff88e88 47682-397 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation HYDROCORTISONE 10 mg/g N 20181231 47682-399_57992c82-b03d-763e-e053-2a91aa0a6ea6 47682-399 HUMAN OTC DRUG Derma-Caine benzalkonium chloride, lidocaine hydrochloride CREAM TOPICAL 20120131 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g N 20181231 47682-406_070d5713-e000-2913-e054-00144ff8d46c 47682-406 HUMAN OTC DRUG Medi-First Pep-T-Med Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20111201 OTC MONOGRAPH FINAL part335 Unifirst First Aid Corporation BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 47682-410_6053448c-9fb7-b53e-e053-2991aa0a93db 47682-410 HUMAN OTC DRUG Green Guard First Aid Eye Wash Water SOLUTION OPHTHALMIC 20111202 OTC MONOGRAPH FINAL part349 Unifirst First Aid Corporation WATER .983 mg/mL N 20181231 47682-411_1a48c89e-9f43-6145-e054-00144ff88e88 47682-411 HUMAN OTC DRUG First Aid Eye Wash Water SOLUTION OPHTHALMIC 20140515 OTC MONOGRAPH FINAL part349 Unifirst First Aid Corporation WATER .929 g/946mL N 20181231 47682-412_6053448c-9fb7-b53e-e053-2991aa0a93db 47682-412 HUMAN OTC DRUG Green Guard First Aid Eye Wash Water SOLUTION OPHTHALMIC 20151001 OTC MONOGRAPH FINAL part349 Unifirst First Aid Corporation WATER .983 mg/mL N 20181231 47682-450_a3bdcbf3-41e3-47bc-a2eb-1cbaaf251e1e 47682-450 HUMAN OTC DRUG Medi-first Protective Coating Bandage benzethonium chloride and benzocaine AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation BENZETHONIUM CHLORIDE; BENZOCAINE 170; 2720 mg/85g; mg/85g N 20181231 47682-456_603f3ce9-6f2c-b461-e053-2a91aa0afaf3 47682-456 HUMAN OTC DRUG Bayer Genuine Aspirin Aspirin TABLET, COATED ORAL 20140124 OTC MONOGRAPH FINAL part343 Unifirst First Aid Corporation ASPIRIN 325 mg/1 N 20181231 47682-458_4431508e-2d91-6d79-e054-00144ff8d46c 47682-458 HUMAN OTC DRUG Medique ColdEeze Zinc Gluconate LOZENGE ORAL 20110330 UNAPPROVED HOMEOPATHIC Unifirs First-Aid Corporation ZINC GLUCONATE 2 [hp_X]/1 N 20181231 47682-477_3ec1dce3-cfe8-14df-e054-00144ff8d46c 47682-477 HUMAN OTC DRUG Medi-First Burn Lidocaine Hydrochloride GEL TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation LIDOCAINE HYDROCHLORIDE 20 mg/g N 20181231 47682-480_e03e0e32-9422-4c17-8436-b8b0043f5ebe 47682-480 HUMAN OTC DRUG Medique Medi-Meclizine MECLIZINE HYDROCHLORIDE TABLET ORAL 20130901 OTC MONOGRAPH FINAL part336 Unifirst First Aid Corporation MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 47682-487_681a80be-542f-4060-9e43-3c947de438b5 47682-487 HUMAN OTC DRUG Medi-first Ivy-Rid First Aid benzocaine and benzethonium chloride AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BENZOCAINE; BENZETHONIUM CHLORIDE 4250; 127.5 mg/85g; mg/85g N 20181231 47682-488_603ec392-785e-2cc9-e053-2a91aa0a77bc 47682-488 HUMAN OTC DRUG Bayer Aleve Naproxen Sodium TABLET ORAL 20140124 NDA NDA020204 Unifirst First Aid Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 47682-509_42ec722e-9808-2ec4-e054-00144ff88e88 47682-509 HUMAN OTC DRUG Otis Clapp Mygrex ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 47682-511_3f150683-5367-330d-e054-00144ff88e88 47682-511 HUMAN OTC DRUG Hand Sanitizer alcohol GEL TOPICAL 20130409 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation ALCOHOL 540.26 g/L N 20181231 47682-522_1ef6d566-64c3-4ecc-b11a-d952f010de93 47682-522 HUMAN OTC DRUG Hand Sanitizer benzalkonium chloride LIQUID TOPICAL 20130409 OTC MONOGRAPH NOT FINAL part333E Unifirst First Aid Corporation BENZALKONIUM CHLORIDE .0039 mg/mL N 20181231 47682-543_4f2fd4c1-b699-58ac-e054-00144ff88e88 47682-543 HUMAN OTC DRUG Otis Clapp Valihist ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 47682-581_39a1cff1-21e0-4a7d-8277-d64daf2ae9d9 47682-581 HUMAN OTC DRUG Medi-First Medi-First OINTMENT TOPICAL 20091020 OTC MONOGRAPH FINAL part333A Medique Products BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [USP'U]/1; mg/1; [USP'U]/1 N 20181231 47682-587_1465efb8-b89a-553e-e054-00144ff8d46c 47682-587 HUMAN OTC DRUG Otis Clapp Back Quell MAGNESIUM SALICYLATE, ACETAMINOPHEN TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation MAGNESIUM SALICYLATE; ACETAMINOPHEN 200; 200 mg/1; mg/1 N 20181231 47682-600_470461c7-a1f0-68bc-e054-00144ff88e88 47682-600 HUMAN OTC DRUG Medique Iprin Ibuprofen TABLET, COATED ORAL 20160201 ANDA ANDA075010 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 N 20181231 47682-602_470461c7-a1f0-68bc-e054-00144ff88e88 47682-602 HUMAN OTC DRUG Otis Clapp Ultraprin Ibuprofen TABLET, COATED ORAL 20160201 ANDA ANDA075010 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 N 20181231 47682-608_470461c7-a1f0-68bc-e054-00144ff88e88 47682-608 HUMAN OTC DRUG Medi-First Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20160201 ANDA ANDA075010 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 N 20181231 47682-609_470461c7-a1f0-68bc-e054-00144ff88e88 47682-609 HUMAN OTC DRUG Medi-First Plus Ibuprofen Ibuprofen TABLET, COATED ORAL 20160201 ANDA ANDA075010 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 N 20181231 47682-610_4703863a-4153-4d22-e054-00144ff88e88 47682-610 HUMAN OTC DRUG Green Guard Ibupro relief Ibuprofen TABLET, COATED ORAL 20160201 ANDA ANDA075010 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 N 20181231 47682-614_470461c7-a1f0-68bc-e054-00144ff88e88 47682-614 HUMAN OTC DRUG Dover Addaprin Ibuprofen TABLET, COATED ORAL 20160201 ANDA ANDA075010 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 N 20181231 47682-700_3ed3b7a3-8d68-3435-e054-00144ff88e88 47682-700 HUMAN OTC DRUG Medique Iprin Ibuprofen TABLET, COATED ORAL 20170126 ANDA ANDA079174 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 N 20181231 47682-702_3ed3b7a3-8d68-3435-e054-00144ff88e88 47682-702 HUMAN OTC DRUG Otis Clapp Ultraprin Ibuprofen TABLET, COATED ORAL 20141117 ANDA ANDA079174 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 N 20181231 47682-708_3ed3b7a3-8d68-3435-e054-00144ff88e88 47682-708 HUMAN OTC DRUG Medi-First Ibuprofen Ibuprofen TABLET, COATED ORAL 20170126 ANDA ANDA079174 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 N 20181231 47682-709_3ed3b7a3-8d68-3435-e054-00144ff88e88 47682-709 HUMAN OTC DRUG Medi-First Plus Ibuprofen Ibuprofen TABLET, COATED ORAL 20170126 ANDA ANDA079174 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 N 20181231 47682-710_47033909-4191-299e-e054-00144ff8d46c 47682-710 HUMAN OTC DRUG Green Guard Ibuprofen Relief Ibuprofen TABLET, COATED ORAL 20170126 ANDA ANDA079174 Unifirst First Aid IBUPROFEN 200 mg/1 N 20181231 47682-714_3ed3b7a3-8d68-3435-e054-00144ff88e88 47682-714 HUMAN OTC DRUG Dover Addaprin Ibuprofen TABLET, COATED ORAL 20170126 ANDA ANDA079174 Unifirst First Aid Corporation IBUPROFEN 200 mg/1 N 20181231 47682-803_4159c76c-deef-0f00-e054-00144ff8d46c 47682-803 HUMAN OTC DRUG MEDI-FIRST Non-Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 N 20181231 47682-804_415c9a90-a897-2c4c-e054-00144ff8d46c 47682-804 HUMAN OTC DRUG MEDI-FIRST Non-Aspirin Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 N 20181231 47682-809_42ae186d-5d89-4bb2-e054-00144ff8d46c 47682-809 HUMAN OTC DRUG Medi-First Sinus Decongestant PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 47682-810_439ee5be-ec61-5ff0-e054-00144ff88e88 47682-810 HUMAN OTC DRUG Medi First Cramp ACETAMINOPHEN, PAMABROM TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; PAMABROM 325; 25 mg/1; mg/1 N 20181231 47682-811_609f7c7d-8f75-507e-e053-2a91aa0aac74 47682-811 HUMAN OTC DRUG Medi First Pain Relief ACETAMINOPHEN, ASPIRIN, SALICYLAMIDE and CAFFEINE TABLET ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; ASPIRIN; SALICYLAMIDE; CAFFEINE 110; 162; 152; 32.4 mg/1; mg/1; mg/1; mg/1 N 20181231 47682-815_0cb25f1b-6f4c-73ed-e054-00144ff88e88 47682-815 HUMAN OTC DRUG MEDI-FIRST Cherry Cough Drops MENTHOL LOZENGE ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation MENTHOL 7.6 mg/1 N 20181231 47682-819_42ec722e-9808-2ec4-e054-00144ff88e88 47682-819 HUMAN OTC DRUG Medi First Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 47682-820_d5880d7b-898b-44c1-a861-16ba7dbc5564 47682-820 HUMAN OTC DRUG Medi-First Antacid calcium carbonate TABLET, CHEWABLE ORAL 20140615 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 N 20181231 47682-889_46c38500-670b-27ab-e054-00144ff8d46c 47682-889 HUMAN OTC DRUG Medique Medi-lax BISACODYL TABLET, DELAYED RELEASE ORAL 20081230 OTC MONOGRAPH NOT FINAL part334 Unifirst First Aid Corporation BISACODYL 5 mg/1 N 20181231 47682-903_4159c76c-deef-0f00-e054-00144ff8d46c 47682-903 HUMAN OTC DRUG Medi First Plus Non-Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 325 mg/1 N 20181231 47682-904_415c9a90-a897-2c4c-e054-00144ff8d46c 47682-904 HUMAN OTC DRUG Medi First Plus Non-Aspirin Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN 500 mg/1 N 20181231 47682-910_439ee5be-ec61-5ff0-e054-00144ff88e88 47682-910 HUMAN OTC DRUG Medi First Plus Cramp ACETAMINOPHEN, PAMABROM TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; PAMABROM 325; 25 mg/1; mg/1 N 20181231 47682-911_609f7c7d-8f75-507e-e053-2a91aa0aac74 47682-911 HUMAN OTC DRUG Medi First Plus Pain Zapper ACETAMINOPHEN, ASPIRIN, SALICYLAMIDE and CAFFEINE TABLET ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Unifirst First Aid Corporation ACETAMINOPHEN; ASPIRIN; SALICYLAMIDE; CAFFEINE 110; 162; 152; 32.4 mg/1; mg/1; mg/1; mg/1 N 20181231 47682-915_0cb25f1b-6f4c-73ed-e054-00144ff88e88 47682-915 HUMAN OTC DRUG Medi First Plus Cherry Cough Drops MENTHOL LOZENGE ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation MENTHOL 7.6 mg/1 N 20181231 47682-919_42ec722e-9808-2ec4-e054-00144ff88e88 47682-919 HUMAN OTC DRUG Medi First Plus Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Unifirst First Aid Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 47682-920_d5880d7b-898b-44c1-a861-16ba7dbc5564 47682-920 HUMAN OTC DRUG Medi-First Plus Antacid calcium carbonate TABLET, CHEWABLE ORAL 20140615 OTC MONOGRAPH FINAL part331 Unifirst First Aid Corporation CALCIUM CARBONATE 420 mg/1 N 20181231 47682-931_56e14d3c-99a4-54a5-e054-00144ff88e88 47682-931 HUMAN OTC DRUG MEDI-FIRST PLUS STERILE ALCOHOL PADS Isopropyl Alcohol LIQUID TOPICAL 20111223 OTC MONOGRAPH NOT FINAL part333A Unifirst First Aid Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 47682-933_5de6f369-1b2a-4fa8-8a64-3d85af46e71d 47682-933 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation HYDROCORTISONE 10 mg/g N 20181231 47682-934_3fc9b991-142e-48aa-e054-00144ff8d46c 47682-934 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20130412 OTC MONOGRAPH FINAL part333B Unifirst First Aid Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 47682-935_53337fde-6b7f-0564-e054-00144ff88e88 47682-935 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine OINTMENT TOPICAL 20130920 20180801 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; LIDOCAINE HYDROCHLORIDE 400; 3.5; 5000; 40 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 47682-936_baebc527-d18f-459a-bf2c-503cb9d34237 47682-936 HUMAN OTC DRUG Medi-First Plus First Aid Eye Wash Water SOLUTION OPHTHALMIC 20111202 OTC MONOGRAPH FINAL part349 Unifirst First Aid Corporation WATER .983 mg/mL N 20181231 47682-937_5709a184-54d4-3d0c-e054-00144ff8d46c 47682-937 HUMAN OTC DRUG Medi-First Plus Burn Cream Lidocaine CREAM TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE .5; .13 g/100g; g/100g N 20181231 47682-940_57ea7f8a-26e3-367e-e053-2a91aa0a93e1 47682-940 HUMAN OTC DRUG Medi-First Plus Burn Cream Benzalkonium chloride, Lidocaine HCl CREAM TOPICAL 20170829 OTC MONOGRAPH NOT FINAL part348 Unifirst First Aid Corporation LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE 5; 1.3 mg/g; mg/g N 20181231 47781-100_b48e595c-7f82-47f3-f1ca-27a0a81cb6f9 47781-100 HUMAN PRESCRIPTION DRUG nevirapine nevirapine TABLET ORAL 20120522 ANDA ANDA203176 Alvogen Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] E 20171231 47781-103_93d541f4-0c4b-3002-17b4-511ded18489d 47781-103 HUMAN PRESCRIPTION DRUG IBANDRONATE SODIUM IBANDRONATE SODIUM TABLET ORAL 20140501 ANDA ANDA078998 Alvogen Inc. IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 47781-108_abc57677-3d42-1329-b744-7939c4fd22e1 47781-108 HUMAN PRESCRIPTION DRUG Exemestane Exemestane TABLET ORAL 20140725 ANDA ANDA200898 Alvogen Inc. EXEMESTANE 25 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 47781-135_d68d9432-67d1-4171-b372-6b4bdad01748 47781-135 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10mL Ophthalmic Solution 2%, 10mL Dorzolamide Hydrochloride Ophthalmic Solution 2%, 10mL SOLUTION OPHTHALMIC 20131216 ANDA ANDA091034 ALVOGEN INC. DORZOLAMIDE HYDROCHLORIDE 22.3 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] E 20171231 47781-136_28d35df3-b0d6-1dad-0bfa-0c257b62c3b2 47781-136 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution Sterile Ophthalmic Solution Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution SOLUTION OPHTHALMIC 20131217 ANDA ANDA091180 ALVOGEN INC. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 22.3; 6.8 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 47781-137_6bdf899f-39fd-9215-0840-50981b13ef54 47781-137 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride Olopatadine Hydrochloride USP, 0.1% SOLUTION/ DROPS OPHTHALMIC 20151208 ANDA ANDA204706 Alvogen Inc. OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] E 20171231 47781-138_15132438-5ff9-8f37-d3b0-1d220da0f73d 47781-138 HUMAN PRESCRIPTION DRUG Rasagiline Mesylate Rasagiline Mesylate TABLET ORAL 20161219 ANDA ANDA201970 Alvogen, Inc. RASAGILINE MESYLATE .5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 47781-139_15132438-5ff9-8f37-d3b0-1d220da0f73d 47781-139 HUMAN PRESCRIPTION DRUG Rasagiline Mesylate Rasagiline Mesylate TABLET ORAL 20161219 ANDA ANDA201970 Alvogen, Inc. RASAGILINE MESYLATE 1 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 47781-146_04077f26-b87c-1617-1fd1-c19f5a80ea93 47781-146 HUMAN PRESCRIPTION DRUG Budesonide (enteric coated) Budesonide CAPSULE ORAL 20161128 ANDA ANDA206724 Alvogen, Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 47781-147_1d137c2c-fd59-4203-8115-b0a25a282bef 47781-147 HUMAN PRESCRIPTION DRUG Gadopentetate dimeglumine Gadopentetate dimeglumine INJECTION INTRAVENOUS 20140224 NDA AUTHORIZED GENERIC NDA019596 Alvogen, Inc GADOPENTETATE DIMEGLUMINE 469.01 mg/mL N 20181231 47781-147_7a334ed0-990b-4d48-bd67-7273f5451a25 47781-147 HUMAN PRESCRIPTION DRUG Gadopentetate dimeglumine gadopentetate dimeglumine INJECTION INTRAVENOUS 20140224 NDA AUTHORIZED GENERIC NDA021037 Alvogen, Inc GADOPENTETATE DIMEGLUMINE 469.01 mg/mL N 20181231 47781-153_40fcba9f-9b69-4136-4b9e-2c80729b308c 47781-153 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150311 NDA AUTHORIZED GENERIC NDA020353 Alvogen Inc. NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 47781-154_40fcba9f-9b69-4136-4b9e-2c80729b308c 47781-154 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150311 NDA AUTHORIZED GENERIC NDA020353 Alvogen Inc. NAPROXEN SODIUM 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 47781-155_40fcba9f-9b69-4136-4b9e-2c80729b308c 47781-155 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150311 NDA AUTHORIZED GENERIC NDA020353 Alvogen Inc. NAPROXEN SODIUM 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 47781-174_3d822ef0-3532-f916-c7d2-1e6f6ee798cf 47781-174 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 5 mg,Cll TABLET ORAL 20170728 ANDA ANDA207388 Alvogen inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 47781-175_3d822ef0-3532-f916-c7d2-1e6f6ee798cf 47781-175 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 7.5 mg,Cll TABLET ORAL 20170728 ANDA ANDA207388 Alvogen inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 47781-176_3d822ef0-3532-f916-c7d2-1e6f6ee798cf 47781-176 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 10 mg,Cll TABLET ORAL 20170728 ANDA ANDA207388 Alvogen inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 47781-177_3d822ef0-3532-f916-c7d2-1e6f6ee798cf 47781-177 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 12.5 mg,Cll TABLET ORAL 20170728 ANDA ANDA207388 Alvogen inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 47781-178_3d822ef0-3532-f916-c7d2-1e6f6ee798cf 47781-178 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 mg,Cll TABLET ORAL 20170728 ANDA ANDA207388 Alvogen inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 47781-179_3d822ef0-3532-f916-c7d2-1e6f6ee798cf 47781-179 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 20 mg,Cll TABLET ORAL 20170728 ANDA ANDA207388 Alvogen inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 47781-180_3d822ef0-3532-f916-c7d2-1e6f6ee798cf 47781-180 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 30 mg,Cll TABLET ORAL 20170728 ANDA ANDA207388 Alvogen inc. AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 47781-196_dc7b344d-a92b-8910-63e5-21da6aac9c8a 47781-196 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20160309 ANDA ANDA202677 Alvogen, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 47781-200_8cbb7338-0bf3-0df7-5e77-641bbca6cf32 47781-200 HUMAN PRESCRIPTION DRUG Melphalan Melphalan USP, 2 mg TABLET ORAL 20170322 ANDA ANDA207809 Alvogen Inc. MELPHALAN 2 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 47781-204_77003e01-a778-4305-a226-e068f944a464 47781-204 HUMAN PRESCRIPTION DRUG Estradiol Transdermal System Estradiol PATCH TRANSDERMAL 20111220 NDA NDA020375 Alvogen, Inc. ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 47781-205_77003e01-a778-4305-a226-e068f944a464 47781-205 HUMAN PRESCRIPTION DRUG Estradiol Transdermal System Estradiol PATCH TRANSDERMAL 20111220 NDA NDA020375 Alvogen, Inc. ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 47781-206_77003e01-a778-4305-a226-e068f944a464 47781-206 HUMAN PRESCRIPTION DRUG Estradiol Transdermal System Estradiol PATCH TRANSDERMAL 20111220 NDA NDA020375 Alvogen, Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 47781-207_77003e01-a778-4305-a226-e068f944a464 47781-207 HUMAN PRESCRIPTION DRUG Estradiol Transdermal System Estradiol PATCH TRANSDERMAL 20111220 NDA NDA020375 Alvogen, Inc. ESTRADIOL .06 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 47781-208_77003e01-a778-4305-a226-e068f944a464 47781-208 HUMAN PRESCRIPTION DRUG Estradiol Transdermal System Estradiol PATCH TRANSDERMAL 20111220 NDA NDA020375 Alvogen, Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 47781-209_77003e01-a778-4305-a226-e068f944a464 47781-209 HUMAN PRESCRIPTION DRUG Estradiol Transdermal System Estradiol PATCH TRANSDERMAL 20111219 NDA NDA020375 Alvogen, Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 47781-229_dc7b344d-a92b-8910-63e5-21da6aac9c8a 47781-229 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120117 ANDA ANDA202677 Alvogen, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 47781-230_dc7b344d-a92b-8910-63e5-21da6aac9c8a 47781-230 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120117 ANDA ANDA202677 Alvogen, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 47781-256_6cd4cb66-6689-0727-ee16-7ebac75c1b3b 47781-256 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION INTRAVENOUS 20171231 ANDA ANDA065515 Alvogen Inc. DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] E 20171231 47781-263_58682e56-beb4-e8b8-94f5-90ad764a8909 47781-263 HUMAN PRESCRIPTION DRUG Oxycodone hydrochloride Oxycodone hydrochloride TABLET ORAL 20111230 ANDA ANDA202116 Alvogen, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 47781-264_58682e56-beb4-e8b8-94f5-90ad764a8909 47781-264 HUMAN PRESCRIPTION DRUG Oxycodone hydrochloride Oxycodone hydrochloride TABLET ORAL 20111230 ANDA ANDA202116 Alvogen, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 47781-265_58682e56-beb4-e8b8-94f5-90ad764a8909 47781-265 HUMAN PRESCRIPTION DRUG Oxycodone hydrochloride Oxycodone hydrochloride TABLET ORAL 20111230 ANDA ANDA202116 Alvogen, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 47781-266_3232eab3-5f88-4c41-bdab-c1fd71e8dfe9 47781-266 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 20100118 ANDA ANDA065146 Alvogen, Inc. CEFACLOR 250 mg/1 E 20171231 47781-267_3232eab3-5f88-4c41-bdab-c1fd71e8dfe9 47781-267 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 20100118 ANDA ANDA065146 Alvogen, Inc. CEFACLOR 500 mg/1 E 20171231 47781-268_54fff5fe-c97e-453e-807f-c1255d5dacfe 47781-268 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20140129 NDA AUTHORIZED GENERIC NDA021085 Alvogen, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 47781-296_10ad7a20-e9df-703b-65d8-3f415a9543df 47781-296 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20101110 ANDA ANDA089771 Alvogen, Inc. NITROGLYCERIN .1 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 47781-297_10ad7a20-e9df-703b-65d8-3f415a9543df 47781-297 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20101110 ANDA ANDA089772 Alvogen, Inc. NITROGLYCERIN .2 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 47781-298_10ad7a20-e9df-703b-65d8-3f415a9543df 47781-298 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20101110 ANDA ANDA089773 Alvogen, Inc. NITROGLYCERIN .4 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 47781-299_10ad7a20-e9df-703b-65d8-3f415a9543df 47781-299 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20101110 ANDA ANDA089774 Alvogen, Inc. NITROGLYCERIN .6 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 47781-303_05f79c61-f9c5-cd77-2c56-262f0be11d36 47781-303 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Alvogen Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 47781-304_c3078cd7-d5cb-ce9a-cb32-856416c46605 47781-304 HUMAN PRESCRIPTION DRUG Rivastigmine Transdermal System Rivastigmine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20150904 ANDA ANDA204403 Alvogen Inc. RIVASTIGMINE 4.6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 47781-305_c3078cd7-d5cb-ce9a-cb32-856416c46605 47781-305 HUMAN PRESCRIPTION DRUG Rivastigmine Transdermal System Rivastigmine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20150904 ANDA ANDA204403 Alvogen Inc. RIVASTIGMINE 9.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 47781-306_a2c45dcd-462b-f5f9-450f-57f20da39729 47781-306 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Alvogen Inc. NITROFURANTOIN 25 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 47781-307_a2c45dcd-462b-f5f9-450f-57f20da39729 47781-307 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Alvogen Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 47781-308_a2c45dcd-462b-f5f9-450f-57f20da39729 47781-308 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Alvogen Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 47781-317_b9b81616-719b-12f5-1ce8-a5776aad7656 47781-317 HUMAN PRESCRIPTION DRUG Nevirapine Extended Release nevirapine TABLET ORAL 20150714 ANDA ANDA204621 Alvogen Inc. NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 47781-331_1333abef-2b71-3b54-679c-ec20b5047b65 47781-331 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET, FILM COATED ORAL 20111208 ANDA ANDA203924 Alvogen, Inc. PRIMAQUINE PHOSPHATE 26.3 mg/1 Antimalarial [EPC] E 20171231 47781-332_f673b96b-a928-41dc-6dd0-c30495807e44 47781-332 HUMAN PRESCRIPTION DRUG Carbidopa Tablets, 25 mg Carbidopa Tablets, 25 mg TABLET ORAL 20160125 ANDA ANDA204291 Alvogen Inc. CARBIDOPA 25 mg/1 N 20181231 47781-333_e0409fb4-899e-b8c9-148d-dfaa7bebf72b 47781-333 HUMAN PRESCRIPTION DRUG Dapsone dapsone TABLET ORAL 20160613 ANDA ANDA205429 Alvogen Inc. DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 47781-334_e0409fb4-899e-b8c9-148d-dfaa7bebf72b 47781-334 HUMAN PRESCRIPTION DRUG Dapsone dapsone TABLET ORAL 20160613 ANDA ANDA205429 Alvogen Inc. DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 47781-335_e05cdb0c-57ba-4965-321f-c37be13728d7 47781-335 HUMAN PRESCRIPTION DRUG Pyridostigmine Bromide Pyridostigmine Bromide TABLET, EXTENDED RELEASE ORAL 20150629 ANDA ANDA204737 Alvogen, Inc. PYRIDOSTIGMINE BROMIDE 180 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 47781-340_6b3a1576-6f9a-4dd3-b5f7-794c81ce335a 47781-340 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20080130 NDA AUTHORIZED GENERIC NDA020482 Alvogen, Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 47781-341_6b3a1576-6f9a-4dd3-b5f7-794c81ce335a 47781-341 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20080130 NDA AUTHORIZED GENERIC NDA020482 Alvogen, Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 47781-342_6b3a1576-6f9a-4dd3-b5f7-794c81ce335a 47781-342 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20080130 NDA AUTHORIZED GENERIC NDA020482 Alvogen, Inc. ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 47781-368_8e12f321-920c-5a5d-e854-69d925918b3e 47781-368 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130611 NDA AUTHORIZED GENERIC NDA020198 Alvogen Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 47781-369_8e12f321-920c-5a5d-e854-69d925918b3e 47781-369 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130611 NDA AUTHORIZED GENERIC NDA020198 Alvogen Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 47781-370_8e12f321-920c-5a5d-e854-69d925918b3e 47781-370 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130611 NDA AUTHORIZED GENERIC NDA020198 Alvogen Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 47781-384_a79fc56c-af33-1709-6345-0a0c6e2d7883 47781-384 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate for Oral Suspension Oseltamivir Phosphate POWDER, FOR SUSPENSION ORAL 20171101 ANDA ANDA208823 Alvogen Inc. OSELTAMIVIR PHOSPHATE 6 mg/mL N 20181231 47781-405_c3078cd7-d5cb-ce9a-cb32-856416c46605 47781-405 HUMAN PRESCRIPTION DRUG Rivastigmine Transdermal System Rivastigmine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20150902 ANDA ANDA204403 Alvogen Inc. RIVASTIGMINE 13.3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 47781-423_0d2070d5-ae1f-489c-bb99-de0b660b5042 47781-423 HUMAN PRESCRIPTION DRUG Fentanyl System Fentanyl PATCH TRANSDERMAL 20161104 ANDA ANDA202097 Alvogen, Inc. FENTANYL 12.5 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 47781-424_0d2070d5-ae1f-489c-bb99-de0b660b5042 47781-424 HUMAN PRESCRIPTION DRUG Fentanyl System Fentanyl PATCH TRANSDERMAL 20161104 ANDA ANDA202097 Alvogen, Inc. FENTANYL 25 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 47781-426_0d2070d5-ae1f-489c-bb99-de0b660b5042 47781-426 HUMAN PRESCRIPTION DRUG Fentanyl System Fentanyl PATCH TRANSDERMAL 20161104 ANDA ANDA202097 Alvogen, Inc. FENTANYL 50 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 47781-427_0d2070d5-ae1f-489c-bb99-de0b660b5042 47781-427 HUMAN PRESCRIPTION DRUG Fentanyl System Fentanyl PATCH TRANSDERMAL 20161104 ANDA ANDA202097 Alvogen, Inc. FENTANYL 75 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 47781-428_0d2070d5-ae1f-489c-bb99-de0b660b5042 47781-428 HUMAN PRESCRIPTION DRUG Fentanyl System Fentanyl PATCH TRANSDERMAL 20161104 ANDA ANDA202097 Alvogen, Inc. FENTANYL 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 47781-447_10f4efa7-8095-450c-9731-dfaec9905076 47781-447 HUMAN PRESCRIPTION DRUG Azelaic Acid azelaic acid GEL TOPICAL 20150708 NDA AUTHORIZED GENERIC NDA021470 Alvogen, Inc. AZELAIC ACID .15 g/g Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] E 20171231 47781-459_85c8222f-6c15-ed7b-4487-d14ec112f462 47781-459 HUMAN PRESCRIPTION DRUG Clindamycin clindamycin phosphate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160603 ANDA ANDA062800 Alvogen Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 47781-460_85c8222f-6c15-ed7b-4487-d14ec112f462 47781-460 HUMAN PRESCRIPTION DRUG Clindamycin clindamycin phosphate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160127 ANDA ANDA062800 Alvogen Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 47781-461_85c8222f-6c15-ed7b-4487-d14ec112f462 47781-461 HUMAN PRESCRIPTION DRUG Clindamycin clindamycin phosphate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160603 ANDA ANDA062800 Alvogen Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 47781-462_f640727f-6d06-fd56-e0cf-0237ea1d77cd 47781-462 HUMAN PRESCRIPTION DRUG Clindamycin clindamycin phosphate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20151113 ANDA ANDA062801 Alvogen Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 47781-463_f640727f-6d06-fd56-e0cf-0237ea1d77cd 47781-463 HUMAN PRESCRIPTION DRUG Clindamycin clindamycin phosphate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20151130 ANDA ANDA062801 Alvogen Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 47781-464_f640727f-6d06-fd56-e0cf-0237ea1d77cd 47781-464 HUMAN PRESCRIPTION DRUG Clindamycin clindamycin phosphate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160121 ANDA ANDA062801 Alvogen Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 47781-465_54f12c4f-0834-f0fc-c859-d7136d24f987 47781-465 HUMAN PRESCRIPTION DRUG Clindamycin clindamycin phosphate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160315 ANDA ANDA062943 Alvogen Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 47781-466_ba83c484-7ae1-6895-bc38-7c693c0db6ed 47781-466 HUMAN PRESCRIPTION DRUG VORICONAZOLE VORICONAZOLE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160808 ANDA ANDA206398 Alvogen Inc. VORICONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 47781-468_2d26de8f-35a6-9d94-1696-cc8c65ba152c 47781-468 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir phosphate CAPSULE ORAL 20161212 ANDA ANDA202595 Alvogen Inc. OSELTAMIVIR PHOSPHATE 30 mg/1 N 20181231 47781-469_2d26de8f-35a6-9d94-1696-cc8c65ba152c 47781-469 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir phosphate CAPSULE ORAL 20161212 ANDA ANDA202595 Alvogen Inc. OSELTAMIVIR PHOSPHATE 45 mg/1 N 20181231 47781-470_2d26de8f-35a6-9d94-1696-cc8c65ba152c 47781-470 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir phosphate CAPSULE ORAL 20161212 ANDA ANDA202595 Alvogen Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 47781-476_6e8fe795-2a4b-428b-ad16-4a201105de86 47781-476 HUMAN PRESCRIPTION DRUG PARICALCITOL paricalcitol CAPSULE ORAL 20180101 ANDA ANDA206710 ALVOGEN, INC. PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 47781-477_6e8fe795-2a4b-428b-ad16-4a201105de86 47781-477 HUMAN PRESCRIPTION DRUG PARICALCITOL paricalcitol CAPSULE ORAL 20180101 ANDA ANDA206710 ALVOGEN, INC. PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 47781-478_6e8fe795-2a4b-428b-ad16-4a201105de86 47781-478 HUMAN PRESCRIPTION DRUG PARICALCITOL paricalcitol CAPSULE ORAL 20180101 ANDA ANDA206710 ALVOGEN, INC. PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 47781-489_e3cefb68-c74b-875e-60e1-e24e0e6d8cba 47781-489 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20160627 ANDA ANDA062500 Alvogen, Inc. DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 47781-490_e3cefb68-c74b-875e-60e1-e24e0e6d8cba 47781-490 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20160627 ANDA ANDA062500 Alvogen, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 47781-491_e3cefb68-c74b-875e-60e1-e24e0e6d8cba 47781-491 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20160627 ANDA ANDA062505 Alvogen, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 47781-508_37019f3f-c5ab-63b8-ef1e-b5c109f09a16 47781-508 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20161219 ANDA ANDA062752 Alvogen Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 47781-509_37019f3f-c5ab-63b8-ef1e-b5c109f09a16 47781-509 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20161219 ANDA ANDA062752 Alvogen Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 47781-518_0f0b1ffc-96a9-f9ee-2408-7d3b38bbb12a 47781-518 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20171117 ANDA ANDA207805 Alvogen Inc. FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 47781-519_0f0b1ffc-96a9-f9ee-2408-7d3b38bbb12a 47781-519 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20171117 ANDA ANDA207805 Alvogen Inc. FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 47781-520_0f0b1ffc-96a9-f9ee-2408-7d3b38bbb12a 47781-520 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20171117 ANDA ANDA207805 Alvogen Inc. FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 47781-530_41708987-6fb4-e9b2-1d88-a17b93b07fda 47781-530 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox GEL TOPICAL 20170214 NDA NDA020519 Alvogen Inc. CICLOPIROX 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 47781-532_174aea30-7ca8-42f7-8525-a0fe8841a454 47781-532 HUMAN PRESCRIPTION DRUG Fluocinonide Cream (Emulsified Base) Fluocinonide Cream (Emulsified Base) CREAM TOPICAL 20170714 NDA NDA016908 Alvogen Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 47781-533_e416a391-2137-2b2a-d798-f3e6eb1b2b50 47781-533 HUMAN PRESCRIPTION DRUG Fluocinonide Gel Fluocinonide Gel GEL TOPICAL 20170214 NDA NDA017373 Alvogen Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 47781-534_60b2d2d7-0340-4adc-e053-2a91aa0ab876 47781-534 HUMAN PRESCRIPTION DRUG butalbital and acetaminophen butalbital and acetaminophen TABLET ORAL 20170606 ANDA ANDA207635 Alvogen Inc. BUTALBITAL; ACETAMINOPHEN 50; 300 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 47781-535_e835ff5e-9cba-b66d-88d6-cc8dfe9d072e 47781-535 HUMAN PRESCRIPTION DRUG Butalbital and Acetaminophen Butalbital and Acetaminophen TABLET ORAL 20170224 ANDA ANDA205120 Alvogen, Inc. ACETAMINOPHEN; BUTALBITAL 325; 50 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 47781-536_2c97f5cf-36d5-9c7c-10c2-5da43b998b44 47781-536 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine butalbital, acetaminophen, and caffeine TABLET ORAL 20170130 ANDA ANDA204984 Alvogen Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 47781-537_bda7c102-b0b0-7d0f-821e-0d3d09f63e70 47781-537 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20170407 ANDA ANDA206840 Alvogen Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 47781-538_bda7c102-b0b0-7d0f-821e-0d3d09f63e70 47781-538 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20161114 ANDA ANDA206840 Alvogen Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 47781-539_bda7c102-b0b0-7d0f-821e-0d3d09f63e70 47781-539 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20161114 ANDA ANDA206840 Alvogen Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 47781-540_1aead5c6-7b62-f509-99ab-37c761d4ef8f 47781-540 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20171020 ANDA ANDA204772 Alvogen Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 47781-541_1aead5c6-7b62-f509-99ab-37c761d4ef8f 47781-541 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20171020 ANDA ANDA204772 Alvogen Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 47781-543_670999d0-7a38-080a-41ed-c97240a85b3d 47781-543 HUMAN PRESCRIPTION DRUG Econazole Nitrate Cream Econazole Nitrate Cream CREAM TOPICAL 20170907 NDA NDA018751 Alvogen Inc. ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 47781-544_dbe9f7f7-5240-80fd-2910-36b24e1c1ab9 47781-544 HUMAN PRESCRIPTION DRUG minocycline hydrochloride minocycline hydrochloride CAPSULE ORAL 20171031 ANDA ANDA063066 Alvogen, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 47781-545_dbe9f7f7-5240-80fd-2910-36b24e1c1ab9 47781-545 HUMAN PRESCRIPTION DRUG minocycline hydrochloride minocycline hydrochloride CAPSULE ORAL 20171031 ANDA ANDA063067 Alvogen, Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 47781-546_dbe9f7f7-5240-80fd-2910-36b24e1c1ab9 47781-546 HUMAN PRESCRIPTION DRUG minocycline hydrochloride minocycline hydrochloride CAPSULE ORAL 20171031 ANDA ANDA063067 Alvogen, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 47781-550_761ba76f-a2bf-e13e-4eda-0421e00d9f6c 47781-550 HUMAN PRESCRIPTION DRUG Felbamate felbamate TABLET ORAL 20161228 ANDA ANDA204595 Alvogen Inc. FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 47781-551_761ba76f-a2bf-e13e-4eda-0421e00d9f6c 47781-551 HUMAN PRESCRIPTION DRUG Felbamate felbamate TABLET ORAL 20161228 ANDA ANDA204595 Alvogen Inc. FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 47781-569_617d2297-0cd6-757d-ab09-a24b65b54d64 47781-569 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 20171002 NDA NDA016909 Alvogen Inc. FLUOCINONIDE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 47781-570_9896b918-34f8-1573-978c-e80bac78d37c 47781-570 HUMAN OTC DRUG Lidocaine Lidocaine CREAM TOPICAL 20180112 OTC MONOGRAPH NOT FINAL part348 Alvogen Inc. LIDOCAINE 40 mg/g N 20191231 47781-577_7a9dfd96-da64-0144-cd7f-21e1d756e738 47781-577 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20100503 NDA NDA016151 Alvogen Inc. METHENAMINE HIPPURATE 1 g/1 N 20181231 47781-578_6d0fbbe0-a755-ec98-0b79-8b3348ed0a5d 47781-578 HUMAN PRESCRIPTION DRUG Dexrazoxane Dexrazoxane for Injection INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170901 ANDA ANDA207321 Alvogen Inc. DEXRAZOXANE HYDROCHLORIDE 500 mg/50mL Cytoprotective Agent [EPC] N 20181231 47781-583_ee8a12e3-1d4b-22f5-1236-0494bcab3022 47781-583 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170929 ANDA ANDA204216 Alvogen Inc. KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 47781-584_ee8a12e3-1d4b-22f5-1236-0494bcab3022 47781-584 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170929 ANDA ANDA204216 Alvogen Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 47781-585_ee8a12e3-1d4b-22f5-1236-0494bcab3022 47781-585 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR 20170929 ANDA ANDA204216 Alvogen Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 47781-586_0f752ae9-5d61-dfa1-4c13-18bcfeefdcc0 47781-586 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION INTRAVENOUS 20170601 ANDA ANDA090699 Alvogen Inc. LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 47781-587_6a744456-a1c0-2d13-2208-04ca28315444 47781-587 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate INJECTION, SOLUTION INTRAVENOUS 20171102 ANDA ANDA204205 Alvogen Inc. METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 47781-588_26bce648-5e94-cb0c-fdf0-a63ea22bce20 47781-588 HUMAN PRESCRIPTION DRUG Midazolam midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170811 ANDA ANDA090696 Alvogen Inc. MIDAZOLAM HYDROCHLORIDE 2 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 47781-589_4bc62708-1301-eec7-724d-8032b15b8083 47781-589 HUMAN PRESCRIPTION DRUG Midazolam midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170811 ANDA ANDA090850 Alvogen Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 47781-591_1abde18c-0062-e588-0318-cc7f1cda4291 47781-591 HUMAN PRESCRIPTION DRUG Oxaliplatin oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20170731 ANDA ANDA207325 Alvogen Inc. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 47781-592_1abde18c-0062-e588-0318-cc7f1cda4291 47781-592 HUMAN PRESCRIPTION DRUG Oxaliplatin oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20170731 ANDA ANDA207325 Alvogen Inc. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 47781-593_e7a03882-3788-2beb-a50f-b16f2d85c142 47781-593 HUMAN PRESCRIPTION DRUG Paclitaxel paclitaxel INJECTION, SOLUTION INTRAVENOUS 20171227 ANDA ANDA207326 Alvogen Inc. PACLITAXEL 30 mg/5mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 47781-594_e7a03882-3788-2beb-a50f-b16f2d85c142 47781-594 HUMAN PRESCRIPTION DRUG Paclitaxel paclitaxel INJECTION, SOLUTION INTRAVENOUS 20171227 ANDA ANDA207326 Alvogen Inc. PACLITAXEL 100 mg/16.7mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 47781-595_e7a03882-3788-2beb-a50f-b16f2d85c142 47781-595 HUMAN PRESCRIPTION DRUG Paclitaxel paclitaxel INJECTION, SOLUTION INTRAVENOUS 20171227 ANDA ANDA207326 Alvogen Inc. PACLITAXEL 300 mg/50mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 47781-596_89406b65-8778-f74e-c3d8-cbad6606dfde 47781-596 HUMAN PRESCRIPTION DRUG Polymyxin B polymyxin B sulfate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20170923 ANDA ANDA207322 Alvogen Inc. POLYMYXIN B SULFATE 500000 [iU]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 47781-597_36f72ae8-9bfc-9d7b-e164-19eb013ae092 47781-597 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170828 ANDA ANDA205694 Alvogen Inc. VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 47781-598_36f72ae8-9bfc-9d7b-e164-19eb013ae092 47781-598 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170828 ANDA ANDA205694 Alvogen Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 47781-600_99322e46-ea68-0c8b-7c77-7bd9511faf34 47781-600 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride TABLET, FILM COATED ORAL 20170901 NDA NDA202133 Alvogen Inc. FLUOXETINE HYDROCHLORIDE 60 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 47781-601_1360a48c-1be5-d604-6e28-03214d88f259 47781-601 HUMAN PRESCRIPTION DRUG Tranexamic Acid tranexamic acid INJECTION, SOLUTION INTRAVENOUS 20170901 ANDA ANDA207239 Alvogen Inc. TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 47781-603_4c3e61ea-5958-df98-abff-2ec3779afc87 47781-603 HUMAN PRESCRIPTION DRUG CARBOPLATIN Carboplatin INJECTION, SOLUTION INTRAVENOUS 20180201 ANDA ANDA207324 Alvogen Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20191231 47781-605_4c3e61ea-5958-df98-abff-2ec3779afc87 47781-605 HUMAN PRESCRIPTION DRUG CARBOPLATIN Carboplatin INJECTION, SOLUTION INTRAVENOUS 20180201 ANDA ANDA207324 Alvogen Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20191231 47781-607_b7fe114c-6473-5751-f631-664dab513a17 47781-607 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20120831 ANDA ANDA091681 Alvogen Inc. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 47781-609_88e08beb-d19a-d59f-c1b2-c9990f8a12a9 47781-609 HUMAN PRESCRIPTION DRUG Cisplatin cisplatin INJECTION, SOLUTION INTRAVENOUS 20170925 ANDA ANDA207323 Alvogen Inc. CISPLATIN 50 mg/50mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 47781-610_88e08beb-d19a-d59f-c1b2-c9990f8a12a9 47781-610 HUMAN PRESCRIPTION DRUG Cisplatin cisplatin INJECTION, SOLUTION INTRAVENOUS 20170925 ANDA ANDA207323 Alvogen Inc. CISPLATIN 100 mg/100mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 47781-613_339d41a1-7b73-8bec-2c43-47315244bf99 47781-613 HUMAN PRESCRIPTION DRUG Caspofungin Acetate caspofungin acetate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171201 ANDA ANDA207092 Alvogen Inc. CASPOFUNGIN ACETATE 5 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 47781-614_339d41a1-7b73-8bec-2c43-47315244bf99 47781-614 HUMAN PRESCRIPTION DRUG Caspofungin Acetate caspofungin acetate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171201 ANDA ANDA207092 Alvogen Inc. CASPOFUNGIN ACETATE 7 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 47781-619_587d460a-13a9-46d4-9f60-e4ff82e52940 47781-619 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 20171109 ANDA ANDA062803 Alvogen, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 47781-620_587d460a-13a9-46d4-9f60-e4ff82e52940 47781-620 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 20171109 ANDA ANDA062803 Alvogen, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 47781-621_587d460a-13a9-46d4-9f60-e4ff82e52940 47781-621 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAVENOUS 20171109 ANDA ANDA062803 Alvogen, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 47781-729_510ac736-ef6b-9a32-83c0-75d768416ce4 47781-729 HUMAN PRESCRIPTION DRUG vancomycin hydrochloride vancomycin hydrochloride CAPSULE ORAL 20120409 ANDA ANDA065490 Alvogen, Inc. VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 47781-730_510ac736-ef6b-9a32-83c0-75d768416ce4 47781-730 HUMAN PRESCRIPTION DRUG vancomycin hydrochloride vancomycin hydrochloride CAPSULE ORAL 20120409 ANDA ANDA065490 Alvogen, Inc. VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 47783-101_c24d5ed0-0fd4-4af2-971c-31869be9c9d5 47783-101 HUMAN PRESCRIPTION DRUG KALBITOR ECALLANTIDE INJECTION, SOLUTION SUBCUTANEOUS 20100202 BLA BLA125277 Dyax Corp. ECALLANTIDE 10 mg/mL Plasma Kallikrein Inhibitor [EPC],Kallikrein Inhibitors [MoA] N 20181231 47784-001_fb1962d5-b6a6-4f41-a88d-33c891d5961b 47784-001 HUMAN OTC DRUG SinuClean ECBALLIUM ELATERIUM SOLUTION SPRAY NASAL 20091022 UNAPPROVED HOMEOPATHIC Galsor S.r.l ECBALLIUM ELATERIUM FRUIT 22.09 mL/100mL E 20171231 47832-205_2d439d76-d59a-4456-9afb-5e187e1e6c93 47832-205 HUMAN OTC DRUG Hydrocortisone Acetate Hydrocortisone Acetate CREAM TOPICAL 20070124 OTC MONOGRAPH NOT FINAL part348 Bentlin Products LLC HYDROCORTISONE ACETATE 10 mg/g N 20181231 47918-874_67688ef7-19b8-435e-af8d-19a8f2ee5db8 47918-874 HUMAN PRESCRIPTION DRUG Afrezza Insulin Human POWDER, METERED RESPIRATORY (INHALATION) 20140711 NDA NDA022472 Mannkind Corporation INSULIN HUMAN 4 1/1 Insulin [Chemical/Ingredient],Insulin [EPC] N 20181231 47918-878_67688ef7-19b8-435e-af8d-19a8f2ee5db8 47918-878 HUMAN PRESCRIPTION DRUG Afrezza Insulin Human POWDER, METERED RESPIRATORY (INHALATION) 20140711 NDA NDA022472 Mannkind Corporation INSULIN HUMAN 8 1/1 Insulin [Chemical/Ingredient],Insulin [EPC] N 20181231 47918-880_67688ef7-19b8-435e-af8d-19a8f2ee5db8 47918-880 HUMAN PRESCRIPTION DRUG Afrezza Insulin Human KIT 20140711 NDA NDA022472 Mannkind Corporation N 20181231 47918-882_67688ef7-19b8-435e-af8d-19a8f2ee5db8 47918-882 HUMAN PRESCRIPTION DRUG Afrezza Insulin Human KIT 20140711 NDA NDA022472 Mannkind Corporation N 20181231 47918-884_67688ef7-19b8-435e-af8d-19a8f2ee5db8 47918-884 HUMAN PRESCRIPTION DRUG Afrezza Insulin Human KIT 20140711 NDA NDA022472 Mannkind Corporation N 20181231 47918-891_67688ef7-19b8-435e-af8d-19a8f2ee5db8 47918-891 HUMAN PRESCRIPTION DRUG Afrezza Insulin Human POWDER, METERED RESPIRATORY (INHALATION) 20140711 NDA NDA022472 Mannkind Corporation INSULIN HUMAN 12 1/1 Insulin [Chemical/Ingredient],Insulin [EPC] N 20181231 47918-894_67688ef7-19b8-435e-af8d-19a8f2ee5db8 47918-894 HUMAN PRESCRIPTION DRUG Afrezza Insulin Human KIT 20140711 NDA NDA022472 Mannkind Corporation N 20181231 47918-902_67688ef7-19b8-435e-af8d-19a8f2ee5db8 47918-902 HUMAN PRESCRIPTION DRUG Afrezza Insulin Human KIT 20140711 NDA NDA022472 Mannkind Corporation N 20181231 47993-200_448d8025-3f44-4582-90e7-7042e5072bf1 47993-200 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20140503 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 62 g/100g N 20181231 47993-200_4fbf9b20-2596-4424-a123-eefb5a3defee 47993-200 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20140503 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 62 g/100g N 20181231 47993-200_6043d837-2c47-674a-e053-2a91aa0a05fd 47993-200 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20140503 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 62 g/100g N 20181231 47993-200_8e1eee4c-d7d7-4105-9c3e-4546024b8de1 47993-200 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20140503 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 62 g/100g N 20181231 47993-200_fbccc24b-0404-4a62-a6d8-2b14cb3ee6a2 47993-200 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20140503 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 62 g/100g N 20181231 47993-201_5fa3f98d-87bc-075e-e053-2a91aa0a2af4 47993-201 HUMAN OTC DRUG Hand Sanitizer Spraying ALCOHOL SPRAY TOPICAL 20140503 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 62 g/100g N 20181231 47993-202_5fa3f98d-87c8-075e-e053-2a91aa0a2af4 47993-202 HUMAN OTC DRUG Hand Sanitizer Spraying ALCOHOL SPRAY TOPICAL 20140503 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 65 g/100g N 20181231 47993-203_5fa46357-c5a7-a19e-e053-2991aa0a93ce 47993-203 HUMAN OTC DRUG HAND SANITIZER HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL 62 g/100g N 20181231 47993-204_5fa964bb-55a7-1f45-e053-2a91aa0ad913 47993-204 HUMAN OTC DRUG HAND SANITIZER HAND SANITIZER LIQUID TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part356 NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD CITRIC ACID MONOHYDRATE; COCAMIDOPROPYL BETAINE .3; 5 g/100g; 1/100g N 20181231 47993-205_5fa964bb-5593-1f45-e053-2a91aa0ad913 47993-205 HUMAN OTC DRUG Foam Hand Washing Foam Hand Washing LIQUID TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD BENZALKONIUM CHLORIDE 2 g/100g N 20181231 47993-206_5fb6439f-7bb6-5896-e053-2991aa0a3b81 47993-206 HUMAN OTC DRUG HAND WASHING HAND WASHING LIQUID TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part356 NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD CITRIC ACID MONOHYDRATE .3 g/100g N 20181231 47993-207_601d10e7-6936-a6c3-e053-2a91aa0a8a51 47993-207 HUMAN OTC DRUG WHITE HAND SANITIZER HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL; .ALPHA.-TOCOPHEROL ACETATE, DL-; TITANIUM DIOXIDE 62; .6; .1 g/100g; g/100g; g/100g N 20181231 47993-215_3d823247-5b8e-4c29-ba34-e3f4ba06c486 47993-215 HUMAN OTC DRUG SUN BLOCK SPRARY SUN BLOCK SPRARY SPF15 SPRAY TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part352 NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD HOMOSALATE; OCTINOXATE 3; 6 g/100g; g/100g N 20191231 47993-215_63098fb5-213b-79dd-e053-2a91aa0a1ad7 47993-215 HUMAN OTC DRUG SUN BLOCK SPRARY SUN BLOCK SPRARY SPF15 SPRAY TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part352 NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD HOMOSALATE; OCTINOXATE 3; 6 g/100g; g/100g N 20191231 47993-215_ff63b216-2f70-4d48-8718-a45ee040fe51 47993-215 HUMAN OTC DRUG SUN BLOCK SPRARY SUN BLOCK SPRARY SPF15 SPRAY TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part352 NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD HOMOSALATE; OCTINOXATE 3; 6 g/100g; g/100g N 20191231 47993-216_63098fb5-2144-79dd-e053-2a91aa0a1ad7 47993-216 HUMAN OTC DRUG Sunscreen SPF30 Sunscreen SPF30 LIQUID TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part352 NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD PEG-100 STEARATE; TITANIUM DIOXIDE; ETHYLHEXYL METHOXYCRYLENE; BENZOPHENONE; AVOBENZONE 2.5; 4; 1.25; .5; .75 g/100g; g/100g; g/100g; g/100g; g/100g N 20191231 47993-220_5fa8d7a6-0e82-f26f-e053-2991aa0a6f65 47993-220 HUMAN OTC DRUG Aloe Vera Gel Aloe Vera Gel GEL TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part356 NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD GLYCERIN; PROPYLENE GLYCOL 10; 4 g/100g; g/100g N 20181231 47993-221_5faaf264-c10a-4dc0-e053-2a91aa0a28bc 47993-221 HUMAN OTC DRUG Aloe Vera Sprayer Aloe Vera Sprayer LIQUID TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part334 NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD GLYCERIN; PROPYLENE GLYCOL; ALOE VERA LEAF; TOCOPHEROL 4; 2; 2; .5 g/100g; g/100g; g/100g; g/100g N 20181231 47993-230_164e2ad7-7852-4087-9b00-61e408e3fa7c 47993-230 HUMAN OTC DRUG ALCOHOL FREE HAND SANITIZER ALCOHOL FREE HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD TRICLOSAN .3 g/100g N 20181231 47993-230_8d174431-87a6-4ad6-82fb-15ee6a524a44 47993-230 HUMAN OTC DRUG ALCOHOL FREE HAND SANITIZER ALCOHOL FREE HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD TRICLOSAN .3 g/100g N 20181231 47993-230_8e5dc0ba-0748-4982-a3ea-4019db4c1bc4 47993-230 HUMAN OTC DRUG ALCOHOL FREE HAND SANITIZER ALCOHOL FREE HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD TRICLOSAN .3 g/100g N 20181231 47993-230_9a53a9c4-e5d3-4358-86e4-b2175372041a 47993-230 HUMAN OTC DRUG ALCOHOL FREE HAND SANITIZER ALCOHOL FREE HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD TRICLOSAN .3 g/100g N 20181231 47993-230_d879d71b-fdd4-4a77-a84d-807f01dba5e8 47993-230 HUMAN OTC DRUG ALCOHOL FREE HAND SANITIZER ALCOHOL FREE HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD TRICLOSAN .3 g/100g N 20181231 47993-230_de706e7f-0c14-4234-a339-055f311598ef 47993-230 HUMAN OTC DRUG ALCOHOL FREE HAND SANITIZER ALCOHOL FREE HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD TRICLOSAN .3 g/100g N 20181231 47993-230_e55ff85e-91c5-4f62-8f94-2f799e3bf1f6 47993-230 HUMAN OTC DRUG ALCOHOL FREE HAND SANITIZER ALCOHOL FREE HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD TRICLOSAN .3 g/100g N 20181231 47993-230_ef0d813c-9aad-4bc7-8a71-0c8360f5f65b 47993-230 HUMAN OTC DRUG ALCOHOL FREE HAND SANITIZER ALCOHOL FREE HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD TRICLOSAN .3 g/100g N 20181231 47993-231_5fa94e8d-d398-535b-e053-2991aa0a54df 47993-231 HUMAN OTC DRUG Alcohol Free Hand Sanitizer Alcohol Free Hand Sanitizer LIQUID TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part333A NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD BENZALKONIUM CHLORIDE .3 g/100g N 20181231 47993-240_5fa96261-fabe-21d1-e053-2991aa0a24f8 47993-240 HUMAN OTC DRUG anti-frizz sheets anti-frizz sheets SWAB TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD SULISOBENZONE 2 g/100g N 20181231 47993-301_5fb74303-319a-738e-e053-2a91aa0a37cf 47993-301 HUMAN OTC DRUG HAND SANITIZER WITH VE ALCOHOL LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL; .ALPHA.-TOCOPHEROL ACETATE, DL- 62; 1.5 g/100g; g/100g N 20181231 47993-302_9db8eee8-4e02-4c1f-9e0e-5786340c3dcf 47993-302 HUMAN OTC DRUG WHITE HAND SANITIZER HAND SANITIZER LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL; .ALPHA.-TOCOPHEROL ACETATE, DL-; TITANIUM DIOXIDE 62; .6; .1 g/100g; g/100g; g/100g E 20171231 47993-304_b4ebbda9-8929-436e-812a-53f41ee235ed 47993-304 HUMAN OTC DRUG HAND SANITIZER WITH VE ALCOHOL LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL; .ALPHA.-TOCOPHEROL ACETATE, DL- 62; 1.5 g/100g; g/100g E 20171231 47993-305_894fb4fc-8d6b-4516-a8b9-647218b15e64 47993-305 HUMAN OTC DRUG HAND SANITIZER WITH VE ALCOHOL LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333E NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD ALCOHOL; .ALPHA.-TOCOPHEROL ACETATE, DL- 62; 1.5 g/100g; g/100g E 20171231 47993-400_5fab2012-60d5-b030-e053-2991aa0a639e 47993-400 HUMAN OTC DRUG antibacterial wet wipes antibacterial wet wipes SWAB TOPICAL 20160915 OTC MONOGRAPH NOT FINAL part333A NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD BENZALKONIUM CHLORIDE .3 g/100g N 20181231 48083-654_3b31c63f-365c-4321-9a1c-e316c218c6d0 48083-654 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20171229 OTC MONOGRAPH FINAL part343 Certified Safety Manufacturing ASPIRIN 325 mg/1 N 20191231 48095-390_a84f370d-5c7e-479a-831a-0cbff527511e 48095-390 HUMAN OTC DRUG Numb Nuts Lidocaine CREAM TOPICAL 20100610 OTC MONOGRAPH FINAL part348 Miss Smarty Pants Enterprises, Inc. LIDOCAINE 4 g/100g E 20171231 48102-021_98c50fe7-0f6f-4417-8d51-d8d9d7082496 48102-021 HUMAN PRESCRIPTION DRUG Cephalexin CEPHALEXIN CAPSULE ORAL 20170602 NDA NDA050405 Fera Pharmaceuticals, LLC CEPHALEXIN 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 48201-001_4404235d-a342-3e6f-e054-00144ff8d46c 48201-001 HUMAN OTC DRUG Sanaflu Xtra ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, GELATIN COATED ORAL 20150430 OTC MONOGRAPH FINAL part341 Grandall Distributing Co., Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 250; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 48201-002_45f84b04-29e0-4545-98fa-1b6c7338aae6 48201-002 HUMAN OTC DRUG Angidol Cherry Flavor BENZOCAINE, MENTHOL LOZENGE ORAL 20150722 OTC MONOGRAPH NOT FINAL part356 Grandall Distributing Co., Inc. BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 48201-003_a85a8077-a9fb-4287-ad7b-c1a53e35875e 48201-003 HUMAN OTC DRUG Angidol Honey Lemon Flavor BENZOCAINE, MENTHOL LOZENGE ORAL 20150722 OTC MONOGRAPH NOT FINAL part356 Grandall Distributing Co., Inc. BENZOCAINE; MENTHOL 15; 2.6 mg/1; mg/1 N 20181231 48201-004_634239e4-edb8-4d5f-99a5-d884a4046c39 48201-004 HUMAN OTC DRUG CALMADOL Camphor, Menthol, Methyl Salicylate LINIMENT TOPICAL 20150708 OTC MONOGRAPH NOT FINAL part348 Grandall Distributing Co., Inc. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 6; 1.9; 10 g/100g; g/100g; g/100g N 20181231 48201-006_3e9b88ec-8c81-486c-acfa-4ab7fd709e80 48201-006 HUMAN OTC DRUG Mata Piojos Lice Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20150709 OTC MONOGRAPH FINAL part358G Grandall Distributing Co., Inc. PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 48201-007_0fdf194e-6f63-4514-8e97-a6cdc8fe6246 48201-007 HUMAN OTC DRUG CALMADOL PAIN RELIEVER Naproxen Sodium TABLET ORAL 20150331 ANDA ANDA090545 Grandall Distributing Co., Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 48201-009_356a1a6a-76b8-0285-e054-00144ff88e88 48201-009 HUMAN OTC DRUG Calmadol Plus ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID TOPICAL 20160616 OTC MONOGRAPH FINAL part341 Grandall Distributing Co., Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 48201-010_60e23e43-02b1-4c4f-e053-2991aa0a0883 48201-010 HUMAN OTC DRUG Sanaflu Nighttime Xtreme Multi Symptom Cold Flu Relief Cherry Flavor ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20170831 OTC MONOGRAPH FINAL part341 Grandall Distributing Co., Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/mL; mg/mL; mg/mL N 20181231 48256-0002_47237012-bb77-42b0-8deb-91b10690c2d9 48256-0002 HUMAN OTC DRUG WHITE FLOWER ANALGESIC BALM CAMPHOR, MENTHOL AND METHYL SALICYLATE OIL TOPICAL 20100611 OTC MONOGRAPH NOT FINAL part348 HOE HIN PAK FAH YEOW MANUFACTORY LTD CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 6; 14.5; 40.02 g/100mL; g/100mL; g/100mL N 20181231 48256-0011_aed88b6f-3582-47a0-8997-0b14f52f9516 48256-0011 HUMAN OTC DRUG WHITE FLOWER ANALGESIC BALM FLORAL SCENTED CAMPHOR, MENTHOL AND METHYL SALICYLATE OIL TOPICAL 20100730 OTC MONOGRAPH NOT FINAL part348 HOE HIN PAK FAH YEOW MANUFACTORY LTD CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 5.4; 13; 35.8 g/100mL; g/100mL; g/100mL N 20181231 48256-0041_167d01fa-8890-4ba1-b0d4-e779f1af4d98 48256-0041 HUMAN OTC DRUG WHITE FLOWER STRAIN RELIEF CAMPHOR, MENTHOL AND METHYL SALICYLATE OIL TOPICAL 20120307 OTC MONOGRAPH NOT FINAL part348 HOE HIN PAK FAH YEOW MANUFACTORY LTD CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10.2; 15.3; 49.1 g/100mL; g/100mL; g/100mL N 20181231 48273-001_79b78253-f9e7-4cdb-b043-e5042372f2e4 48273-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19190101 NDA NDA205767 Keen Compressed Gas Co. Inc. OXYGEN 99 L/100L N 20181231 48273-002_99f582cb-927d-4fbd-a147-f789e8ed648a 48273-002 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19190101 UNAPPROVED MEDICAL GAS Keen Compressed Gas Co. Inc. NITROUS OXIDE 99 L/100L N 20181231 48273-006_52b9e132-8785-4cfd-a1f1-0761c61b65bd 48273-006 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19190101 NDA NDA205766 Keen Compressed Gas Co. Inc. NITROGEN 99 L/100L N 20181231 48273-007_be2bb171-9a4c-4115-9330-463179c4739a 48273-007 HUMAN PRESCRIPTION DRUG MEDICAL AIR AIR GAS RESPIRATORY (INHALATION) 19190101 NDA NDA206023 Keen Compressed Gas Co. Inc. OXYGEN 21 L/100L N 20181231 48324-773_8325368a-b0ee-4917-862a-afc488590ec6 48324-773 HUMAN OTC DRUG Sani Soft ALCOHOL AEROSOL, FOAM TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 Unlimited Sales, Inc. ALCOHOL 620 mg/g E 20171231 48324-785_6b5c38e3-68fa-4926-b5c9-0f92758da48d 48324-785 HUMAN OTC DRUG Instant Hand Sanitizing Wipes BENZETHONIUM CHLORIDE CLOTH TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Unlimited Sales, Inc. BENZETHONIUM CHLORIDE 2 mg/g E 20171231 48404-037_33361927-2f1d-43a1-b2bf-2332ae0baef7 48404-037 HUMAN OTC DRUG pre fense BENZALKONIUM CHLORIDE LIQUID TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E Prefense LLC BENZALKONIUM CHLORIDE 28.39 mg/100mL E 20171231 48404-106_0d37a812-ff1d-4bdc-a4d9-6830e534f72f 48404-106 HUMAN OTC DRUG Prefenz Silica Based Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20090101 OTC MONOGRAPH FINAL part333 Prefense LLC BENZALKONIUM CHLORIDE 12 mL/100mL E 20171231 48417-713_37c5e71a-9f69-4ee3-867c-4a4519a19f0e 48417-713 HUMAN OTC DRUG SaniSuds Antibacterial Foam Chloroxylenol SOAP TOPICAL 20170105 OTC MONOGRAPH NOT FINAL part333E Palmer Fixture Company CHLOROXYLENOL 7.5 mg/mL N 20181231 48417-726_90237e4b-4299-4b82-b481-0f9d1c185b88 48417-726 HUMAN OTC DRUG SaniSuds E-2 Foam Sanitizing Hand Benzalkonium Chloride SOAP TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part333E Palmer Fixture Company BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 48417-750_fe5d7193-3d51-4b9c-b34c-79f0c0238911 48417-750 HUMAN OTC DRUG SaniSuds Foam Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20090407 OTC MONOGRAPH NOT FINAL part333E Palmer Fixture Company BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 48417-780_3c3b2b38-aee4-4894-8e28-507b5c132593 48417-780 HUMAN OTC DRUG SaniSuds Foam Instant Hand Sanitizer Alcohol SOAP TOPICAL 20091111 OTC MONOGRAPH NOT FINAL part333E Palmer Fixture Company ALCOHOL 650 mL/L N 20181231 48433-100_e358437f-7c6b-4e49-957d-d7f5b8f4b8f5 48433-100 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxycycline hyclate TABLET, FILM COATED ORAL 19860710 ANDA ANDA062677 Safecor Health, LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 48433-101_a2586a38-4e2c-4244-8618-0b614d585605 48433-101 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000501 OTC MONOGRAPH NOT FINAL part334 Safecor Health, LLC DOCUSATE SODIUM 250 mg/1 N 20181231 48433-106_636a00a9-9df5-40cb-940a-61cc52016a1b 48433-106 HUMAN OTC DRUG Calcium Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20140825 OTC MONOGRAPH FINAL part331 Safecor Health, LLC CALCIUM CARBONATE 500 mg/1 N 20181231 48433-107_3c2efeee-7e66-4b2b-8fc9-5e68f6076b0b 48433-107 HUMAN OTC DRUG Calcium Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20141001 OTC MONOGRAPH FINAL part331 Safecor Health, LLC CALCIUM CARBONATE 750 mg/1 N 20181231 48433-111_33c8c8f4-faaa-4bda-90c1-56e29c89b516 48433-111 HUMAN OTC DRUG Sore Throat Relief Cherry Flavor BENZOCAINE, MENTHOL LOZENGE ORAL 20140825 OTC MONOGRAPH NOT FINAL part356 Safecor Health, LLC BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 E 20171231 48433-115_97d95498-f430-4647-90fe-eb27a2fa212e 48433-115 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151201 ANDA ANDA078583 Safecor Health, LLC ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 48433-116_97d95498-f430-4647-90fe-eb27a2fa212e 48433-116 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151201 ANDA ANDA078583 Safecor Health, LLC ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 48433-117_97d95498-f430-4647-90fe-eb27a2fa212e 48433-117 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151201 ANDA ANDA078583 Safecor Health, LLC ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 48433-118_97d95498-f430-4647-90fe-eb27a2fa212e 48433-118 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151201 ANDA ANDA078583 Safecor Health, LLC ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 48433-119_97d95498-f430-4647-90fe-eb27a2fa212e 48433-119 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151201 ANDA ANDA078583 Safecor Health, LLC ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 48433-120_97d95498-f430-4647-90fe-eb27a2fa212e 48433-120 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151201 ANDA ANDA078583 Safecor Health, LLC ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 48433-200_1985f628-0cd7-4833-8933-40f07f7a2846 48433-200 HUMAN PRESCRIPTION DRUG Morphine Sulfate morphine sulfate SOLUTION ORAL 20130117 ANDA ANDA202348 Safecor Health, LLC MORPHINE SULFATE 20 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 48433-300_f5a474f0-cbbf-4e79-a820-5c260cf3f0c4 48433-300 HUMAN PRESCRIPTION DRUG Calcium Acetate CALCIUM ACETATE TABLET ORAL 20140815 ANDA ANDA091561 Safecor Health, LLC CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 48433-301_45680e44-1ec1-48ed-81da-7b735ab09b47 48433-301 HUMAN OTC DRUG SENNA SENNOSIDES TABLET, COATED ORAL 20140930 OTC MONOGRAPH NOT FINAL part334 Safecor Health, LLC SENNOSIDES A AND B 8.6 mg/1 N 20181231 48433-302_640680ef-b856-467f-bbaf-1144b290d75d 48433-302 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20140930 OTC MONOGRAPH FINAL part331 Safecor Health, LLC MAGNESIUM OXIDE 400 mg/1 N 20181231 48433-303_97bf4e39-e53b-42fe-b770-03a0f568cff5 48433-303 HUMAN OTC DRUG aspirin low dose chewable aspirin TABLET, CHEWABLE ORAL 20140930 OTC MONOGRAPH NOT FINAL part343 Safecor Health, LLC ASPIRIN 81 mg/1 N 20181231 48433-304_8d0c5a61-4d68-44d1-a600-0261c221daa9 48433-304 HUMAN OTC DRUG Docusate Plus Senna DOCUSATE SODIUM-SENNOSIDES TABLET, FILM COATED ORAL 20140930 OTC MONOGRAPH NOT FINAL part334 Safecor Health, LLC DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; min/1 N 20181231 48433-305_5b102236-e994-4286-ba38-deb16b325228 48433-305 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, COATED ORAL 20140930 OTC MONOGRAPH NOT FINAL part343 Safecor Health, LLC ASPIRIN 325 mg/1 N 20181231 48433-306_0c27d406-45de-4df0-8db0-c3d654fe7637 48433-306 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140930 ANDA ANDA078787 Safecor Health, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 48433-307_0c27d406-45de-4df0-8db0-c3d654fe7637 48433-307 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140930 ANDA ANDA078787 Safecor Health, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 48433-308_790129ef-6a1b-45cb-8b02-25fa8a40c2ba 48433-308 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20140930 ANDA ANDA078414 Safecor Health, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 48433-309_08c7d5d2-c2bf-4c60-baf2-f6ce9f4717d2 48433-309 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20140930 ANDA ANDA086242 Safecor Health, LLC HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 48433-310_78fff200-e2f2-4813-8372-0f9cffdcd987 48433-310 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140930 ANDA ANDA202038 Safecor Health, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 48433-311_2a6a5f26-7d87-4a24-b51b-5613bbc3dbb7 48433-311 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20140930 ANDA ANDA077691 Safecor Health, LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 48433-312_12a9faa9-eb59-4b06-bbc0-7381f8526819 48433-312 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20140930 ANDA ANDA074141 Safecor Health, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 48433-313_89a7ff72-3696-4f6b-aad5-e2600f761332 48433-313 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20140930 ANDA ANDA076670 Safecor Health, LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 48433-314_d7e7508a-6f54-4349-9bd4-238fa48b3ae3 48433-314 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20140930 NDA NDA018569 Safecor Health, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 48433-315_2a297068-6155-40aa-bd2a-1a9ba1147785 48433-315 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140930 ANDA ANDA075743 Safecor Health, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 48433-316_b835dcf6-4cd0-4f68-a485-49182229c48a 48433-316 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20140930 ANDA ANDA077031 Safecor Health, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 48433-317_09447713-fdab-4cb7-90a2-f769693dde6f 48433-317 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20140930 OTC MONOGRAPH NOT FINAL part334 Safecor Health, LLC DOCUSATE SODIUM 100 mg/1 N 20181231 48433-320_1fe298f3-05eb-496d-a49d-4c38ee772d5a 48433-320 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20140930 ANDA ANDA040756 Safecor Health, LLC FOLIC ACID 1 mg/1 N 20181231 48433-321_f7ee9ca2-5123-4230-9666-8eb07a6de8e4 48433-321 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140930 ANDA ANDA040362 Safecor Health, LLC PREDNISONE 20 mg/1 N 20181231 48433-322_b3ad652f-9d8e-4795-9cc4-981eb44d78f1 48433-322 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20140930 ANDA ANDA074726 Safecor Health, LLC POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 48433-323_b3ad652f-9d8e-4795-9cc4-981eb44d78f1 48433-323 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20140930 ANDA ANDA074726 Safecor Health, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 48433-324_55c1bce9-9d05-4621-839d-a98b8d862692 48433-324 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20140930 ANDA ANDA091388 Safecor Health, LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 48433-325_351a8502-fa66-4aea-ba79-cfa050332c51 48433-325 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20140930 ANDA ANDA077351 Safecor Health, LLC FAMOTIDINE 20 mg/1 N 20181231 48433-326_14f29eeb-4db9-47be-a981-1e9f400a2139 48433-326 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140930 ANDA ANDA075978 Safecor Health, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 48433-327_6b537019-dd14-44af-a03f-a0853afa72b1 48433-327 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20140930 ANDA ANDA076048 Safecor Health, LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 48433-328_0c27d406-45de-4df0-8db0-c3d654fe7637 48433-328 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140930 ANDA ANDA078787 Safecor Health, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 48433-329_804e4e29-aadc-4eed-8210-b7013a4a384e 48433-329 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140930 ANDA ANDA202957 Safecor Health, LLC HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 48433-330_804e4e29-aadc-4eed-8210-b7013a4a384e 48433-330 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140930 ANDA ANDA203198 Safecor Health, LLC HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 48433-332_107ac38e-1a9b-40b2-b1e9-22f07e913397 48433-332 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20141001 ANDA ANDA075994 Safecor Health, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 48433-347_5061ddfc-311f-44ff-adde-e71225e38be7 48433-347 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION, CONCENTRATE ORAL 20130923 NDA AUTHORIZED GENERIC NDA200535 Safecor Health, LLC OXYCODONE HYDROCHLORIDE 20 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 48546-0001_dd6eef46-2204-4f08-af70-177f40f927c4 48546-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205767 Indiana Oxygen Company, Inc. OXYGEN 99 L/100L N 20181231 48546-0002_dd6eef46-2204-4f08-af70-177f40f927c4 48546-0002 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19610101 NDA NDA205767 Indiana Oxygen Company, Inc. OXYGEN 99.5 L/100L N 20181231 48546-0003_202abbfb-5e7c-4878-8c81-36e380c6b683 48546-0003 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19750101 NDA NDA205766 Indiana Oxygen Company, Inc. NITROGEN 99 L/100L N 20191231 48599-002_81d1aab5-1230-4c8a-86a9-e70eced7b73d 48599-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS CUTANEOUS; RESPIRATORY (INHALATION) 20160701 NDA NDA205766 Airweld, Inc NITROGEN 99 L/100L N 20181231 48599-345_6385f8cd-9719-4571-80e8-ab1082e0fcf5 48599-345 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS NASAL 19650101 NDA NDA205767 Airweld, Inc. OXYGEN 99 L/100L N 20181231 48663-0001_b139b672-645a-41ed-9ce6-0636f3c65abc 48663-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090415 UNAPPROVED MEDICAL GAS Michael R. Schroeder dba Respiratory Medical Services OXYGEN 99 L/100L E 20171231 48664-001_cd2272bb-6844-4e0d-96ac-8103f3ea87b3 48664-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 19200101 UNAPPROVED MEDICAL GAS Weiler Welding Company OXYGEN 1.13835106 kg/L E 20171231 48664-002_53c7ba03-369c-433a-a854-e5724e06f4a7 48664-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19200101 UNAPPROVED MEDICAL GAS Weiler Welding Company OXYGEN 992 L/1000L E 20171231 48769-060_5490aefc-7dcf-4bc5-a359-bf34907a0486 48769-060 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130101 OTC MONOGRAPH FINAL part338 Softech Pharma Pvt. Ltd DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 48769-112_bf3c674d-cf65-438b-a38a-eca8362d399e 48769-112 HUMAN OTC DRUG SIMETHICONE Dimethicone CAPSULE, LIQUID FILLED ORAL 20120115 OTC MONOGRAPH FINAL part332 Softech Pharma Pvt. Ltd. DIMETHICONE 180 mg/1 N 20181231 48769-113_7871e699-2df2-4655-b2db-a2b721d145ac 48769-113 HUMAN OTC DRUG Simethicone Dimethicone CAPSULE, LIQUID FILLED ORAL 20120115 OTC MONOGRAPH FINAL part332 Softech Pharma Pvt. Ltd DIMETHICONE 125 mg/1 N 20181231 48783-112_f751226c-6ec0-4e10-8f7e-045b2efe0b27 48783-112 HUMAN PRESCRIPTION DRUG Monsels Solution Ferric Subsulfate PASTE TOPICAL 20140610 UNAPPROVED DRUG OTHER Premier Dental Products Company FERRIC SUBSULFATE 210 mg/g Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20191231 48783-500_18bf7dce-a5de-47e4-bb2f-0cf7948e2f11 48783-500 HUMAN OTC DRUG Enamelon Preventive Treatment stannous fluoride GEL DENTAL 20140101 OTC MONOGRAPH FINAL part355 Premier Dental Products Company STANNOUS FLUORIDE .004 g/g N 20191231 48783-520_503bfe9b-75f3-4aaa-8e1c-16a91853af96 48783-520 HUMAN OTC DRUG Enamelon stannous fluoride PASTE, DENTIFRICE DENTAL 20140101 OTC MONOGRAPH FINAL part355 Premier Dental Products Company STANNOUS FLUORIDE .00454 g/g N 20191231 48792-7810_e656e5ff-8ea3-488f-a2c4-f38f5a9b6912 48792-7810 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20150929 ANDA ANDA203584 Sunshine Lake Pharma Co., Ltd. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 48792-7817_e656e5ff-8ea3-488f-a2c4-f38f5a9b6912 48792-7817 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20150929 ANDA ANDA203584 Sunshine Lake Pharma Co., Ltd. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 48815-1001_9f74fdc8-f22c-45b2-ab88-dc8336d44d46 48815-1001 HUMAN PRESCRIPTION DRUG Sodium Iodide I 123 Sodium Iodide I 123 CAPSULE, GELATIN COATED ORAL 20030102 NDA NDA018671 Cardinal Health 418, Inc SODIUM IODIDE I-123 100 uCi/1 N 20181231 48815-1002_9f74fdc8-f22c-45b2-ab88-dc8336d44d46 48815-1002 HUMAN PRESCRIPTION DRUG Sodium Iodide I 123 Sodium Iodide I 123 CAPSULE, GELATIN COATED ORAL 20030102 NDA NDA018671 Cardinal Health 418, Inc SODIUM IODIDE I-123 200 uCi/1 N 20181231 48818-001_f4201d12-9f89-4ce0-a2c9-66d2bcaf12ca 48818-001 HUMAN PRESCRIPTION DRUG Folotyn pralatrexate INJECTION INTRAVENOUS 20090924 NDA NDA022468 Allos Therapeutics PRALATREXATE 20 mg/mL Folate Analog Metabolic Inhibitor [EPC] N 20181231 48871-000_acecdf01-dc1a-4204-8bda-134abf496421 48871-000 HUMAN OTC DRUG CVS Pharmacy benzalkonium chloride, pramoxine hydrochloride SPRAY TOPICAL 20100119 OTC MONOGRAPH FINAL part310.545 Health-Tech, Inc. BENZALKONIUM CHLORIDE; PRAMOXINE HYDROCHLORIDE .195; .15 mL/15mL; mL/15mL E 20171231 48871-001_6c68c1fd-6471-4c20-8ccc-e4e59cc1e3d2 48871-001 HUMAN OTC DRUG Harmon Face Values Hand Sanitizer Spray Alcohol SPRAY TOPICAL 20100331 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. ETHANOL 4.65 mL/7.5mL E 20171231 48871-002_85ea2460-2a0d-4e0f-9430-c30dd74b9a43 48871-002 HUMAN OTC DRUG Hannaford Hand Sanitizer Ethyl alcohol SPRAY TOPICAL 20100331 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. ALCOHOL 4.65 mL/7.5mL E 20171231 48871-003_84059b22-9f9a-493f-b952-1f09bfbd42e8 48871-003 HUMAN OTC DRUG Live Better hand sanitizer benzalkonium chloride SPRAY TOPICAL 20100331 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL E 20171231 48871-005_874c9ac1-9470-4b13-8bcd-72e124fd5160 48871-005 HUMAN OTC DRUG Crayola Hand Sanitizing Foam benzalkonium chloride SPRAY TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL E 20171231 48871-006_6f56256b-561e-438d-8eb3-35b7d14da253 48871-006 HUMAN OTC DRUG Crayola Wild Blue Yonder Roll On Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL E 20171231 48871-007_576bf0fb-aa1b-4d91-ac42-9bf1b81816a7 48871-007 HUMAN OTC DRUG Crayola Radical Red Roll On Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL E 20171231 48871-008_0ef7f255-aca0-4237-aa21-267780aca1d1 48871-008 HUMAN OTC DRUG Oral B Instant Pain Relief benzocaine GEL ORAL OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. BENZOCAINE .2 mL/mL E 20171231 48871-009_18387bfe-dc5b-490e-9a4d-ecc425ac74f4 48871-009 HUMAN OTC DRUG Crayola Sunglow Yellow Roll On Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Health-Tech, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL E 20171231 48871-180_2296992d-070e-4329-955e-3fc9145f0a45 48871-180 HUMAN OTC DRUG Live Better Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Health Tech Inc SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 48878-0231_fed1632d-1c3b-4c4e-b461-cf18662655c7 48878-0231 HUMAN OTC DRUG Avagard D alcohol LOTION TOPICAL 19991001 OTC MONOGRAPH NOT FINAL part333E 3M ESPE Dental Products ALCOHOL 530.7 mg/mL N 20181231 48878-0620_682ddb3d-bb1f-4370-969e-194c39102e8c 48878-0620 HUMAN PRESCRIPTION DRUG Peridex chlorhexidine gluconate RINSE ORAL 19860813 NDA NDA019028 3M ESPE Dental Products CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 48878-3120_d3984963-4b9a-4f0e-b9c3-1dd35651bba9 48878-3120 HUMAN PRESCRIPTION DRUG Clinpro 5000 sodium fluoride PASTE, DENTIFRICE ORAL 20090101 UNAPPROVED DRUG OTHER 3M ESPE Dental Products SODIUM FLUORIDE 5 mg/g N 20181231 48878-3130_d3984963-4b9a-4f0e-b9c3-1dd35651bba9 48878-3130 HUMAN PRESCRIPTION DRUG Clinpro 5000 sodium fluoride PASTE, DENTIFRICE ORAL 20101015 UNAPPROVED DRUG OTHER 3M ESPE Dental Products SODIUM FLUORIDE 5 mg/g N 20181231 48878-3140_d3984963-4b9a-4f0e-b9c3-1dd35651bba9 48878-3140 HUMAN PRESCRIPTION DRUG Clinpro 5000 sodium fluoride PASTE, DENTIFRICE ORAL 20110107 UNAPPROVED DRUG OTHER 3M ESPE Dental Products SODIUM FLUORIDE 5 mg/g N 20181231 48878-3150_199b0dc2-4cf7-411f-96db-788a682969dd 48878-3150 HUMAN OTC DRUG Clinpro Tooth Creme sodium fluoride PASTE, DENTIFRICE ORAL 20130718 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products SODIUM FLUORIDE .95 mg/g N 20181231 48878-3315_e31be793-a0f5-4340-8141-89e3a5480076 48878-3315 HUMAN OTC DRUG PerioMed stannous fluoride RINSE ORAL 19670701 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 1.53 mg/g N 20181231 48878-3317_e31be793-a0f5-4340-8141-89e3a5480076 48878-3317 HUMAN OTC DRUG PerioMed stannous fluoride RINSE ORAL 19670701 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE 1.53 mg/g N 20181231 48878-4020_8039617b-c9e5-4436-9349-46f1c918e9bf 48878-4020 HUMAN OTC DRUG Just For Kids stannous fluoride GEL ORAL 19970701 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE .969 mg/g N 20181231 48878-4061_2b66401d-24b1-4074-9255-64da3b8cb506 48878-4061 HUMAN OTC DRUG OMNI stannous fluoride GEL ORAL 19980201 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE .969 mg/g N 20181231 48878-4070_8039617b-c9e5-4436-9349-46f1c918e9bf 48878-4070 HUMAN OTC DRUG Just For Kids stannous fluoride GEL ORAL 19970701 OTC MONOGRAPH FINAL part355 3M ESPE Dental Products STANNOUS FLUORIDE .969 mg/g N 20181231 48883-001_7b3aa405-9e0a-4a6c-8b72-7368986b442b 48883-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19550101 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases, Ltd. OXYGEN 990 mL/L E 20171231 48883-002_94a87283-d126-49c2-9542-135492092215 48883-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19550101 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases, Ltd. NITROGEN 990 mL/L E 20171231 48883-003_fcf00538-62b2-43fe-b00f-a70b7a73c18a 48883-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20080102 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases, Ltd. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 48883-004_ef3b5bcc-51d6-4ec8-8f5d-d5b8ff7fbba5 48883-004 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RECTAL 20080102 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases, Ltd. NITROUS OXIDE 990 mL/L E 20171231 48883-005_2080f772-ea23-4d7e-89e3-c3083b49a61f 48883-005 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20070401 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases, Ltd. AIR 1000 mL/L E 20171231 48883-006_6c805a0d-190e-4913-8773-189291f0161d 48883-006 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 20090415 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases, Ltd. HELIUM 990 mL/L E 20171231 48883-007_7f1be800-2f65-44ac-b6fa-df6904a1b0ec 48883-007 HUMAN PRESCRIPTION DRUG Helium Oxygen Mix Helium Oxygen Mix GAS RESPIRATORY (INHALATION) 20090415 UNAPPROVED MEDICAL GAS Encompass Medical & Specialty Gases Ltd HELIUM; OXYGEN 500; 500 mL/L; mL/L E 20171231 48948-406_81635a6a-41fc-43eb-8ace-b5a873635dcb 48948-406 HUMAN PRESCRIPTION DRUG Pre-Tabs DHA Prenatal Multi-vitamin/Mineral Supplement with DHA/EPA Sodium Ascorbate, Cholecalciferol, di-alpha-Tocopheryl Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine HCL, Folic Acid, Cyanocobalamin, Calcium Formate, Calcium Carbonate, Ferrous (II) bis-Glycinate Chelate, Potassium Iodide, Zinc Oxide, Choline Bitartrate, with Doconexent and Icosapent KIT 20140615 UNAPPROVED DRUG OTHER DEREMETRX LLC E 20171231 48951-1001_54227e54-5963-61c5-e054-00144ff88e88 48951-1001 HUMAN OTC DRUG Viscum Abietis VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-1002_54228087-7ab3-5561-e054-00144ff8d46c 48951-1002 HUMAN OTC DRUG Viscum Crataegi VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-1003_5423620d-7576-0d30-e054-00144ff88e88 48951-1003 HUMAN OTC DRUG Viscum Mali VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-1004_5420f39d-4754-1ebf-e054-00144ff88e88 48951-1004 HUMAN OTC DRUG Viscum Pini VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-1005_5422419e-0ff6-45f9-e054-00144ff8d46c 48951-1005 HUMAN OTC DRUG Viscum Populi VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-1006_fe0e2f22-a395-433e-8ccb-db619c993ff9 48951-1006 HUMAN OTC DRUG Viscum Quercus VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-1007_2ccc0327-1a79-4199-952b-4a2ed6c976dd 48951-1007 HUMAN OTC DRUG Viscum Salicis VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-1008_54222382-4610-5a14-e054-00144ff88e88 48951-1008 HUMAN OTC DRUG Viscum Tiliae VISCUM ALBUM FRUITING TOP LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-1009_57fb8062-c277-087c-e053-2991aa0a8d00 48951-1009 HUMAN OTC DRUG Aconitum e tub. 6 Aconitum e tub. 6 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS 6 [hp_X]/1 N 20181231 48951-1010_f20c4fed-6c80-4a83-bee1-5a7c5fd4ca35 48951-1010 HUMAN OTC DRUG Adonis Crataegus Special Order Adonis Crataegus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ADONIS VERNALIS FLOWERING TOP; HAWTHORN LEAF WITH FLOWER; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF 3; 3; 3; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1011_57090d1c-221f-23f2-e054-00144ff8d46c 48951-1011 HUMAN OTC DRUG Adonis Crataegus Adonis Crataegus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ADONIS VERNALIS FLOWERING TOP; HAWTHORN LEAF WITH FLOWER; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF 3; 3; 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1013_57090d1c-2211-23f2-e054-00144ff8d46c 48951-1013 HUMAN OTC DRUG Aesculus e cort. 3 Aesculus e cort. 3 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AESCULUS HIPPOCASTANUM BARK 3 [hp_X]/1 N 20181231 48951-1014_56e059ec-e536-3d88-e054-00144ff88e88 48951-1014 HUMAN OTC DRUG Aesculus e cort. 32 Special Order Aesculus e cort. 32 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AESCULUS HIPPOCASTANUM BARK 32 [hp_X]/mL N 20181231 48951-1016_554e309d-b8ec-062e-e054-00144ff88e88 48951-1016 HUMAN OTC DRUG Aesculus Quercus Essence Aesculus Quercus Essence LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BORAGO OFFICINALIS WHOLE; MELILOTUS INDICUS SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; HORSE CHESTNUT; SLOE; QUERCUS ROBUR WHOLE 1; 1; 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1019_e9c3fad7-7a6c-4d5f-baa0-8d838f549e23 48951-1019 HUMAN OTC DRUG Agaricus e pl. tota 4 Special Order Agaricus e pl. tota 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY 4 [hp_X]/mL N 20181231 48951-1021_238d580e-3648-427c-8684-d0400761aedb 48951-1021 HUMAN OTC DRUG Apis Rhus Apis Rhus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BRYONIA ALBA ROOT; TOXICODENDRON PUBESCENS LEAF 2; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1022_553b1a0a-f245-45e2-e054-00144ff88e88 48951-1022 HUMAN OTC DRUG Agaricus Phosphorus Agaricus Phosphorus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DRYOPTERIS FILIX-MAS ROOT; SILVER FLUORIDE; OSTREA EDULIS SHELL; PHOSPHORUS; AMANITA MUSCARIA FRUITING BODY 3; 6; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1023_5708e37c-fc84-1953-e054-00144ff8d46c 48951-1023 HUMAN OTC DRUG Agaricus Phosphorus Agaricus Phosphorus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DRYOPTERIS FILIX-MAS ROOT; SILVER FLUORIDE; OSTREA EDULIS SHELL; PHOSPHORUS; AMANITA MUSCARIA FRUITING BODY 3; 6; 6; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1024_ce684edc-9826-49af-8ce6-3a22d4fc9a80 48951-1024 HUMAN OTC DRUG Agnus castus e sem. 4 Agnus castus e sem. 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANGELICA ARCHANGELICA ROOT; ECHINACEA, UNSPECIFIED; LEVISTICUM OFFICINALE ROOT; ACMELLA OLERACEA WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; CUPRIC ACETATE; INULA HELENIUM ROOT; PLANTAGO MAJOR LEAF; VERBASCUM DENSIFLORUM LEAF 1; 1; 2; 2; 3; 3; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1027_57e7293b-2184-760f-e053-2991aa0ad459 48951-1027 HUMAN OTC DRUG Ammi Nicotiana Adult Size Ammi Nicotiana Adult Size SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMMI VISNAGA FRUIT; MATRICARIA RECUTITA; ATROPA BELLADONNA; TOBACCO LEAF 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1028_553c3301-a934-675f-e054-00144ff88e88 48951-1028 HUMAN OTC DRUG Amnion 30 Amnion 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMNIOTIC FLUID (BOVINE) 30 [hp_X]/mL N 20181231 48951-1030_553c604c-abe9-5ae1-e054-00144ff8d46c 48951-1030 HUMAN OTC DRUG Anagallis Taraxacum Anagallis Taraxacum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANAGALLIS ARVENSIS; MILK THISTLE; FRAGARIA VESCA WHOLE; TARAXACUM PALUSTRE ROOT; VITIS VINIFERA LEAF; CICHORIUM INTYBUS WHOLE; POTASSIUM CARBONATE 5; 5; 5; 5; 5; 7; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1031_5708e37c-fc5c-1953-e054-00144ff8d46c 48951-1031 HUMAN OTC DRUG Anagallis Taraxacum Aanagallis Taraxacum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANAGALLIS ARVENSIS; MILK THISTLE; TARAXACUM PALUSTRE ROOT; FRAGARIA VESCA WHOLE; VITIS VINIFERA LEAF; CICHORIUM INTYBUS WHOLE; POTASSIUM CARBONATE 3; 3; 3; 5; 5; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1032_5a38f8f5-eb7d-4ab6-ae4c-9848ef868898 48951-1032 HUMAN OTC DRUG Ananassa Resina Ananassa Resina LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PINEAPPLE; COLLOIDAL SILICON DIOXIDE; LARIX DECIDUA RESIN 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1033_554d8cc9-981d-2579-e054-00144ff8d46c 48951-1033 HUMAN OTC DRUG Ananassa Resina Ananassa Resina CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PINEAPPLE; LARIX DECIDUA RESIN; SILICON DIOXIDE 2; 2; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1034_5708e37c-fc77-1953-e054-00144ff8d46c 48951-1034 HUMAN OTC DRUG Ananassa Resina Ananassa Resina PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PINEAPPLE; SILICON DIOXIDE; LARIX DECIDUA RESIN 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1035_56e059ec-e528-3d88-e054-00144ff88e88 48951-1035 HUMAN OTC DRUG Angelica Comp. Angelica Comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANGELICA ARCHANGELICA ROOT; ECHINACEA ANGUSTIFOLIA; LEVISTICUM OFFICINALE ROOT; ACMELLA OLERACEA WHOLE; CALENDULA OFFICINALIS FLOWERING TOP; CUPRIC ACETATE; INULA HELENIUM ROOT; PLANTAGO MAJOR LEAF; VERBASCUM DENSIFLORUM LEAF 1; 1; 2; 2; 3; 3; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1036_57098ac2-d48c-3a8e-e054-00144ff8d46c 48951-1036 HUMAN OTC DRUG Anise Pyrite Anise Pyrite PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANISE; FERROUS DISULFIDE; SUCROSE 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1037_579510d4-d5f5-4670-e053-2991aa0a51e5 48951-1037 HUMAN OTC DRUG Antimonite Belladonna Antimonite Belladonna POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; BISMUTH SUBNITRATE 3; 4; 4; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1039_12973323-89bc-41d3-ab23-9335f913fd7e 48951-1039 HUMAN OTC DRUG Aorta 6 Special Order Aorta 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ARTERY 6 [hp_X]/mL N 20181231 48951-1040_7524b8a6-d668-4f7d-9e4d-627dbff58cf6 48951-1040 HUMAN OTC DRUG Aorta Belladonna Aorta Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ARTERY; ATROPA BELLADONNA 5; 5 [hp_X]/1; [hp_X]/1 N 20181231 48951-1041_579510d4-d5e8-4670-e053-2991aa0a51e5 48951-1041 HUMAN OTC DRUG Apatite Cucurbita Apatite Cucurbita POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUCURBITA PEPO FLOWER; FLUORAPATITE 3; 6 g/g; g/g N 20181231 48951-1042_605cac09-3f4f-43c2-ada3-8a0c7bc7259f 48951-1042 HUMAN OTC DRUG Apis Aconitum Apis Aconitum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; ACONITUM NAPELLUS 3; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1043_553cf8a6-8f55-6e63-e054-00144ff8d46c 48951-1043 HUMAN OTC DRUG Apis Arnica Apis Arnica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ARNICA MONTANA 3; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1044_57094b28-598d-00ad-e054-00144ff88e88 48951-1044 HUMAN OTC DRUG Apis Arnica Apis Arnica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ARNICA MONTANA 3; 3 [hp_X]/1; [hp_X]/1 N 20181231 48951-1045_553cf8a6-8f62-6e63-e054-00144ff8d46c 48951-1045 HUMAN OTC DRUG Apis Belladonna Apis Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; APIS MELLIFERA 4; 5 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1046_57962ea7-9ba6-8666-e053-2991aa0ae35f 48951-1046 HUMAN OTC DRUG Apis Belladonna Apis Belladonna CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA; POTASSIUM CHLORIDE; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS 2; 5; 6; 6; 7; 7; 9; 16; 16 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1048_dbab3a74-0b7d-4232-9491-f37ad2826d83 48951-1048 HUMAN OTC DRUG AURUM PLUMBUM AURUM PLUMBUM PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; GOLD; LEAD; HONEY 10; 10; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1049_57096d3d-8d59-7149-e054-00144ff88e88 48951-1049 HUMAN OTC DRUG Apis Belladonna Mercurius Apis Belladonna Mercurius PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; APIS MELLIFERA; MERCURIUS SOLUBILIS 4; 5; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1050_553d7690-fab3-2d4f-e054-00144ff88e88 48951-1050 HUMAN OTC DRUG Apis Bryonia Apis Bryonia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BRYONIA ALBA ROOT 3; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1051_570969e1-ae5c-2dff-e054-00144ff8d46c 48951-1051 HUMAN OTC DRUG Apis Bryonia Special Order Apis Bryonia Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BRYONIA ALBA ROOT 3; 3 [hp_X]/1; [hp_X]/1 N 20181231 48951-1052_9c0596f7-690f-4e54-8db7-bbcc0292f90b 48951-1052 HUMAN OTC DRUG Apis Eucalyptus Special Order Apis Eucalyptus Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; EUCALYPTUS GUM 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1053_8c877615-fdce-4ea0-8fca-e2ff11dd13ad 48951-1053 HUMAN OTC DRUG Apis ex animale 30 Apis ex animale 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 30 [hp_X]/mL N 20181231 48951-1054_f955c702-5567-41cf-a0b7-9003dde78b42 48951-1054 HUMAN OTC DRUG Apis ex animale 30 Special Order Apis ex animale 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 30 [hp_X]/mL N 20181231 48951-1055_57fc1cf7-13ef-f841-e053-2991aa0a31c1 48951-1055 HUMAN OTC DRUG Apis ex animale 4 Special Order Apis ex animale 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 4 [hp_X]/mL N 20181231 48951-1056_553c8cfa-cf16-0b1f-e054-00144ff88e88 48951-1056 HUMAN OTC DRUG Apis ex animale 6 Special Order Apis ex animale 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 6 [hp_X]/mL N 20181231 48951-1057_553e5492-6e36-33d5-e054-00144ff8d46c 48951-1057 HUMAN OTC DRUG Apis Gelsemium Apis Gelsemium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; GELSEMIUM SEMPERVIRENS ROOT; APIS MELLIFERA; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; COLCHICUM AUTUMNALE FLOWER; FORMICA RUFA; ARNICA MONTANA ROOT 3; 3; 4; 4; 5; 5; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1058_553e5492-6e48-33d5-e054-00144ff8d46c 48951-1058 HUMAN OTC DRUG Apis Levisticum Apis Levisticum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; LEVISTICUM OFFICINALE ROOT 3; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1060_553e5492-6e5e-33d5-e054-00144ff8d46c 48951-1060 HUMAN OTC DRUG Apis Phosphorus Apis Phosphorus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; SILVER SULFIDE; PHOSPHORUS 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1061_553e4f01-01b2-2ede-e054-00144ff8d46c 48951-1061 HUMAN OTC DRUG Apis Regina Cerebri Apis Regina Cerebri LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAINSTEM; ROYAL JELLY; ASTRAGALUS PROPINQUUS ROOT 8; 17; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1062_570a7991-b5bd-63d7-e054-00144ff8d46c 48951-1062 HUMAN OTC DRUG Apis regina Cerebri Apis regina Cerebri PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAINSTEM; ROYAL JELLY; ARNICA MONTANA ROOT 8; 17; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1063_91796e59-171f-4b6d-9618-f1397c9f160e 48951-1063 HUMAN OTC DRUG Agaricus e pl. tota 6 Special Order Agaricus e pl. tota 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY 6 [hp_X]/mL N 20181231 48951-1064_57fc1cf7-13e1-f841-e053-2991aa0a31c1 48951-1064 HUMAN OTC DRUG Apis venenum purum 5 Apis venenum purum 5 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA VENOM 5 [hp_X]/mL N 20181231 48951-1065_544ca7e6-922b-0189-e054-00144ff88e88 48951-1065 HUMAN OTC DRUG Aquavit 1 Aquavit 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HONEY; ANGELICA ARCHANGELICA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; EQUISETUM ARVENSE TOP; ST. JOHN'S WORT; IMPERATORIA OSTRUTHIA ROOT; ROSA RUGOSA FLOWER; ROSMARINUS OFFICINALIS FLOWERING TOP; CHAMOMILE; TANGERINE; CARDAMOM; LESSER GALANGAL ROOT; JUNIPER BERRY; LAVANDULA ANGUSTIFOLIA FLOWER; SWEET MARJORAM; ANISE; CENTAURIUM ERYTHRAEA FLOWERING TOP; CARAWAY SEED; COLA NUT; LITSEA CUBEBA FRUIT; FENNEL SEED; FUMARIA OFFICINALIS FLOWERING TOP; HYSSOPUS OFFICINALIS WHOLE; MYRISTICA FRAGRANS WHOLE; BLACK PEPPER; SYZYGIUM AROMATICUM FRUIT; THYME; GINGER; QUILLAJA SAPONARIA BARK; CINNAMON; CORIANDER OIL; SAFFRON; OREGANO; LONG PEPPER; VANILLA; FERROUS ARSENATE; AMBERGRIS; FERRIC OXIDE RED; PRUNUS SPINOSA FLOWER BUD; GOLD 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 8; 10; 11; 11; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1067_553eb5ab-5499-4fd6-e054-00144ff8d46c 48951-1067 HUMAN OTC DRUG Aquilinum Taraxicum Aquilinum Taraxicum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; SALIX PURPUREA BARK; ASPLENIUM SCOLOPENDRIUM TOP; SOLIDAGO CANADENSIS FLOWERING TOP; TARAXACUM PALUSTRE ROOT 5; 5; 5; 5; 5; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1068_57962ea7-9b9b-8666-e053-2991aa0ae35f 48951-1068 HUMAN OTC DRUG Aquilinum Taraxacum Aquilinum Taraxacum CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; SALIX PURPUREA BARK; WILLOW BARK; ASPLENIUM SCOLOPENDRIUM TOP; SOLIDAGO CANADENSIS FLOWERING TOP; TARAXACUM PALUSTRE ROOT 3; 3; 3; 3; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1069_56dfe635-8991-6b22-e054-00144ff8d46c 48951-1069 HUMAN OTC DRUG Aquilinum Taraxacum Aquilinum Taraxacum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; SALIX PURPUREA BARK; WILLOW BARK; SALIX ALBA FLOWER; ASPLENIUM SCOLOPENDRIUM TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM PALUSTRE ROOT 5; 5; 5; 5; 5; 5; 5; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1070_570a7564-2242-6009-e054-00144ff8d46c 48951-1070 HUMAN OTC DRUG Aquilinum Taraxicum Aquilinum Taraxicum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; SALIX PURPUREA BARK; WILLOW BARK; SALIX ALBA FLOWER; ASPLENIUM SCOLOPENDRIUM TOP; SOLIDAGO CANADENSIS FLOWERING TOP; TARAXACUM PALUSTRE ROOT 3; 3; 3; 3; 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1072_54ae6f4b-cf47-09e4-e054-00144ff88e88 48951-1072 HUMAN OTC DRUG Archangelica Eucalyptus Archangelica Eucalyptus OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANGELICA ARCHANGELICA ROOT; EUCALYPTUS OIL 1; 1 [hp_X]/100g; [hp_X]/100g N 20181231 48951-1073_56e04db0-a4fa-322b-e054-00144ff88e88 48951-1073 HUMAN OTC DRUG Argentite Urtica Argentite Urtica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SAW PALMETTO; URTICA DIOICA; ROYAL JELLY; SILVER SULFIDE; BOS TAURUS PITUITARY GLAND; BOS TAURUS TESTICLE 4; 4; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1074_57d32437-c182-6d5b-e053-2a91aa0ac461 48951-1074 HUMAN OTC DRUG Argentum 0.4 Argentum 0.4 OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 1 [hp_X]/g N 20181231 48951-1075_57e6cd1e-fdda-099e-e053-2a91aa0af26e 48951-1075 HUMAN OTC DRUG Argentum 0.4% Adult Argentum 0.4% Adult SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 2 [hp_X]/g N 20181231 48951-1076_553e9f30-3efe-4d21-e054-00144ff8d46c 48951-1076 HUMAN OTC DRUG Argentum 10/20/30 Special Order Argentum 10/20/30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 10 [hp_X]/mL N 20181231 48951-1077_6c6c2c71-7709-460c-8067-8b2750dcface 48951-1077 HUMAN OTC DRUG Argentum 10 Special Order Argentum 10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 10 [hp_X]/mL N 20181231 48951-1079_fba47e7d-49b1-468a-aba8-6ce5ff6e2821 48951-1079 HUMAN OTC DRUG Argentum 17 Special Order Argentum 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 17 [hp_X]/mL N 20181231 48951-1082_a79ee188-f116-4df6-b98e-7f1165fcab6b 48951-1082 HUMAN OTC DRUG Argentum 30 Special Order Argentum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 30 [hp_X]/mL N 20181231 48951-1084_57962ea7-9b8d-8666-e053-2991aa0ae35f 48951-1084 HUMAN OTC DRUG Argentum 5 Argentum 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 5 [hp_X]/g N 20181231 48951-1085_8b2cf79f-cfe5-4e22-919d-04c7e8788f1d 48951-1085 HUMAN OTC DRUG Argentum 6 Argentum 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 6 [hp_X]/mL N 20181231 48951-1087_553ef186-2dc2-5937-e054-00144ff8d46c 48951-1087 HUMAN OTC DRUG Argentum 8 Argentum 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 8 [hp_X]/mL N 20181231 48951-1088_553ed9a5-6b13-5cfb-e054-00144ff88e88 48951-1088 HUMAN OTC DRUG Argentum Bryophyllum Argentum Bryophyllum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; SILVER 6; 10 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1090_5709f29b-aa93-151f-e054-00144ff88e88 48951-1090 HUMAN OTC DRUG Argentum Bryophyllum Argentum Bryophyllum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; SILVER 6; 10 [hp_X]/1; [hp_X]/1 N 20181231 48951-1094_57fc1237-3ce6-46b2-e053-2991aa0acdbd 48951-1094 HUMAN OTC DRUG Argentum nitricum 20 Special Order Argentum nitricum 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 20 [hp_X]/mL N 20181231 48951-1096_57f98678-18a2-1790-e053-2991aa0a5eb7 48951-1096 HUMAN OTC DRUG Argentum Nitricum Argentum Nitricum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 4 [hp_X]/mL N 20181231 48951-1097_5709f29b-aa88-151f-e054-00144ff88e88 48951-1097 HUMAN OTC DRUG Argentum Quartz Argentum Quartz PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; SILICON DIOXIDE 20; 30 [hp_X]/1; [hp_X]/1 N 20181231 48951-1098_553f45a1-605d-6831-e054-00144ff88e88 48951-1098 HUMAN OTC DRUG Argentum Quartz Argentum Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; SILICON DIOXIDE 20; 30 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1099_fac72ca6-d6b3-469e-8b57-070f07f8a673 48951-1099 HUMAN OTC DRUG Argentum Saccharum Special Order Argentum Saccharum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; OXALIS MONTANA LEAF; SUGARCANE 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1100_5709f29b-aa7c-151f-e054-00144ff88e88 48951-1100 HUMAN OTC DRUG Argentum Saccharum Special Order Argentum Saccharum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; OXALIS ACETOSELLA LEAF; SUGARCANE 6; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1101_5709f29b-aa6e-151f-e054-00144ff88e88 48951-1101 HUMAN OTC DRUG Argentum Veratrum Argentum Veratrum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TARAXACUM PALUSTRE ROOT; URTICA DIOICA; CUPRIC SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM; APIS MELLIFERA; SUS SCROFA PANCREAS; SUGARCANE; VERATRUM ALBUM ROOT; SILVER; PHOSPHORUS; BOS TAURUS PARATHYROID GLAND; GOLD 2; 2; 4; 4; 5; 5; 5; 5; 6; 6; 7; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1102_57fa5fc8-5d30-f81d-e053-2991aa0ac47f 48951-1102 HUMAN OTC DRUG Argentum Viscum Argentum Viscum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER CHLORIDE; VISCUM ALBUM FRUITING TOP; BOS TAURUS EYE 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1103_5744609c-8725-6e0e-e053-2991aa0a93c1 48951-1103 HUMAN OTC DRUG Arnica Aconitum Arnica Aconitum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER; BETULA PUBESCENS LEAF; MANDRAGORA OFFICINARUM ROOT; ACONITUM NAPELLUS 1; 2; 2; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1106_553f9507-42f7-7381-e054-00144ff88e88 48951-1106 HUMAN OTC DRUG Arnica Aurum 20/30 Arnica Aurum 20/30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; ARNICA MONTANA; GOLD 3; 3; 4; 20; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1107_5744707f-01d7-53bc-e053-2991aa0a0d18 48951-1107 HUMAN OTC DRUG Arnica Aurum 20/30 Arnica Aurum 20/30 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; ARNICA MONTANA; GOLD 3; 3; 4; 20; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1108_554f5fca-f057-2c78-e054-00144ff88e88 48951-1108 HUMAN OTC DRUG Arnica Aurum 6 10 Arnica Aurum 6 10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; ARNICA MONTANA; GOLD 3; 3; 4; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1109_5744609c-8732-6e0e-e053-2991aa0a93c1 48951-1109 HUMAN OTC DRUG Arnica Aurum 6/10 Arnica Aurum 6/10 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; ARNICA MONTANA; GOLD 3; 3; 4; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1111_554f54e4-481f-6da4-e054-00144ff8d46c 48951-1111 HUMAN OTC DRUG Arnica Aurum Equisetum Arnica Aurum Equisetum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; EQUISETUM ARVENSE TOP; GOLD 3; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1112_57445cd5-20b4-0e4a-e053-2a91aa0ae9a3 48951-1112 HUMAN OTC DRUG Arnica Aurum Equisetum Arnica Aurum Equisetum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; EQUISETUM ARVENSE TOP; GOLD 3; 15; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1113_5744609c-8747-6e0e-e053-2991aa0a93c1 48951-1113 HUMAN OTC DRUG Arnica Berberis Teucrium Arnica Berberis Teucrium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; TEUCRIUM SCORODONIA WHOLE; ARNICA MONTANA 2; 2; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1114_554f5fca-f068-2c78-e054-00144ff88e88 48951-1114 HUMAN OTC DRUG Arnica Betula A Arnica Betula A LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; BETULA PUBESCENS BARK; BOS TAURUS CEREBELLUM; BOS TAURUS BRAIN; BOS TAURUS PITUITARY GLAND; BOS TAURUS EYE; BOS TAURUS NERVE; SUS SCROFA THALAMUS; ARNICA MONTANA; SILICON DIOXIDE; HONEY; LEAD 3; 4; 17; 17; 17; 17; 17; 17; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1115_5744609c-8758-6e0e-e053-2991aa0a93c1 48951-1115 HUMAN OTC DRUG Arnica Betula A Arnica Betula A PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; BETULA PUBESCENS BARK; BOS TAURUS CEREBELLUM; BOS TAURUS BRAIN; BOS TAURUS PITUITARY GLAND; BOS TAURUS EYE; BOS TAURUS NERVE; SUS SCROFA THALAMUS; ARNICA MONTANA; SILICON DIOXIDE; LEAD 3; 4; 17; 17; 17; 17; 17; 17; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1116_554f976f-5728-0282-e054-00144ff8d46c 48951-1116 HUMAN OTC DRUG Arnica Betula B Arnica Betula B LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; BETULA PUBESCENS BARK; BOS TAURUS CEREBELLUM; BOS TAURUS BRAIN; BOS TAURUS PINEAL GLAND; SUS SCROFA EAR; BOS TAURUS NERVE; ARNICA MONTANA; BIFENTHRIN; LEAD; HONEY 3; 4; 17; 17; 17; 17; 17; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1117_544be672-3164-00f5-e054-00144ff8d46c 48951-1117 HUMAN OTC DRUG Arnica Betula B Arnica Betula B PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; BETULA PUBESCENS BARK; BOS TAURUS CEREBELLUM; BOS TAURUS BRAIN; BOS TAURUS PINEAL GLAND; SUS SCROFA EAR; BOS TAURUS NERVE; ARNICA MONTANA; BIFENTHRIN; LEAD; HONEY 3; 4; 17; 17; 17; 17; 17; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1119_7ca32a07-095d-471b-a997-9115a6567f6f 48951-1119 HUMAN OTC DRUG Arnica Calendula Essence Arnica Calendula Essence LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP 1; 1 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1122_fceabd54-8548-4794-80c0-d1d15c376ed8 48951-1122 HUMAN OTC DRUG Arnica e pl. tota 12 Arnica e pl. tota 12 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 12 [hp_X]/1 N 20181231 48951-1123_574501b1-e10f-49eb-e053-2991aa0aabd2 48951-1123 HUMAN OTC DRUG Arnica e pl. tota 2 Arnica e pl. tota 2 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 2 [hp_X]/1 N 20181231 48951-1124_55525087-ab28-1b67-e054-00144ff88e88 48951-1124 HUMAN OTC DRUG Arnica e pl. tota 20 Arnica e pl. tota 20 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 20 [hp_X]/mL N 20181231 48951-1125_d1a99ca9-d05e-49a4-b035-6a0090026e7b 48951-1125 HUMAN OTC DRUG Arnica e pl. tota 20 Special Order Arnica e pl. tota 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 20 [hp_X]/mL N 20181231 48951-1126_549c8694-a34b-11aa-e054-00144ff8d46c 48951-1126 HUMAN OTC DRUG Arnica e pl. tota 3 Arnica e pl. tota 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 3 [hp_X]/mL N 20181231 48951-1128_5744f773-b0aa-37dd-e053-2991aa0a2154 48951-1128 HUMAN OTC DRUG Arnica e pl. tota 3 Arnica e pl. tota 3 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 3 [hp_X]/1 N 20181231 48951-1129_55526532-28e2-6fb3-e054-00144ff8d46c 48951-1129 HUMAN OTC DRUG Arnica e pl. tota 30 Arnica e pl. tota 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 30 [hp_X]/mL N 20181231 48951-1131_5744f773-b0bb-37dd-e053-2991aa0a2154 48951-1131 HUMAN OTC DRUG Arnica e pl. tota 30 Arnica e pl. tota 30 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 30 [hp_X]/1 N 20181231 48951-1132_544cf8f0-1175-1334-e054-00144ff88e88 48951-1132 HUMAN OTC DRUG Arnica e pl. tota 6 Arnica e pl. tota 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 6 [hp_X]/mL N 20181231 48951-1134_7e53a427-4216-4142-8f80-88b25588a33c 48951-1134 HUMAN OTC DRUG Arnica e pl. tota 6 Arnica e pl. tota 6 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 6 [hp_X]/1 N 20181231 48951-1135_22928ea8-198b-489f-81ea-58e4b25081ad 48951-1135 HUMAN OTC DRUG Arnica e rad. 12 Arnica e rad. 12 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT 12 [hp_X]/1 N 20181231 48951-1136_3b5c07cd-3c77-402e-aac1-a33c5214a055 48951-1136 HUMAN OTC DRUG Arnica e rad. 20 Arnica e rad. 20 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT 20 [hp_X]/mL N 20181231 48951-1137_f1656af6-affb-4f57-8c43-94dc831e58b1 48951-1137 HUMAN OTC DRUG Arnica e rad. 6 Special Order Arnica e rad. 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT 6 [hp_X]/1 N 20181231 48951-1139_8a771d63-7bb0-427d-8558-2763f2fa6b9a 48951-1139 HUMAN OTC DRUG Arnica e rad. 30 Arnica e rad. 30 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT 30 [hp_X]/1 N 20181231 48951-1141_fcd03114-494f-4842-a5aa-cd8235dba6b4 48951-1141 HUMAN OTC DRUG Arnica Echinacea Arnica Echinacea LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA LEAF; ST. JOHN'S WORT; ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; COMFREY ROOT 5; 5; 5; 5; 6; 6; 6; 6; 6; 6; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1144_54ae6f4b-cf16-09e4-e054-00144ff88e88 48951-1144 HUMAN OTC DRUG Arnica Arnica LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER 1 [hp_X]/mL N 20181231 48951-1145_57d211ec-c5f2-0761-e053-2991aa0a04c7 48951-1145 HUMAN OTC DRUG Arnica 10% First Aid Arnica 10% First Aid GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER 1 [hp_X]/g N 20181231 48951-1146_54c1a4ce-e569-112e-e054-00144ff8d46c 48951-1146 HUMAN OTC DRUG Arnica Forte Arnica Forte GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER 1 [hp_X]/g N 20181231 48951-1148_883ddf1c-2a28-4712-9b21-0f18c498408e 48951-1148 HUMAN OTC DRUG Arnica Nettle Burn and Bite Arnica Nettle Burn and Bite GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; THUJA OCCIDENTALIS WHOLE; URTICA URENS; LARIX DECIDUA RESIN; LYTTA VESICATORIA; SILVER 2; 2; 2; 2; 2; 3; 6; 7 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1149_769b7aa0-31ca-11df-9aae-0800200c9a66 48951-1149 HUMAN OTC DRUG Arnica Nettle Burn and Bite URTICA URENS CALENDULA OFFICINALIS FLOWERING TOP ARNICA MONTANA FLOWER COMFREY THUJA OCCIDENTALIS TWIG LYTTA VESICATORIA SILVER SPRAY TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc URTICA URENS; CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA FLOWER; COMFREY; THUJA OCCIDENTALIS TWIG; LYTTA VESICATORIA; SILVER 1; 2; 2; 2; 2; 7; 7 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1150_a955eebd-bb38-4e7a-9f25-761ec469b7e0 48951-1150 HUMAN OTC DRUG Arinica Nettle Essence Arnica Nettle Essence LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc URTICA URENS; ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; THUJA OCCIDENTALIS WHOLE; LYTTA VESICATORIA; SILVER 1; 1; 1; 1; 1; 7; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1152_5551b629-14d9-5393-e054-00144ff8d46c 48951-1152 HUMAN OTC DRUG Arnica Plumbum Mel Arnica Plumbum Mel LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; HONEY; LEAD 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1153_5744707f-01e4-53bc-e053-2991aa0a0d18 48951-1153 HUMAN OTC DRUG Arnica Plumbum Mel Arnica Plumbum Mel PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; LEAD; HONEY 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1154_5551b629-14e4-5393-e054-00144ff8d46c 48951-1154 HUMAN OTC DRUG Arnica Retina Arnica Retina LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS EYE; ARNICA MONTANA; EQUISETUM ARVENSE TOP 10; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1155_55520396-b96b-0eaf-e054-00144ff88e88 48951-1155 HUMAN OTC DRUG Arnica Scorodite Arnica Scorodite LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILICON DIOXIDE; ARNICA MONTANA; OSTREA EDULIS SHELL; LEVISTICUM OFFICINALE ROOT; SODIUM CARBONATE; ORCHIS MASCULA TUBER; FLUORAPATITE; FERROUS ARSENATE; BOS TAURUS CEREBELLUM 6; 6; 6; 6; 6; 6; 7; 7; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1156_5744f773-b0cd-37dd-e053-2991aa0a2154 48951-1156 HUMAN OTC DRUG Arnica Scorodite Arnica Scorodite PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILICON DIOXIDE; ARNICA MONTANA; OSTREA EDULIS SHELL; LEVISTICUM OFFICINALE ROOT; SODIUM CARBONATE; ORCHIS MASCULA TUBER; FLUORAPATITE; FERROUS ARSENATE; BOS TAURUS CEREBELLUM 6; 6; 6; 6; 6; 6; 7; 7; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1157_5447e6cb-3baf-23fb-e054-00144ff8d46c 48951-1157 HUMAN OTC DRUG Arnica Stannum Arnica Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; ARNICA MONTANA; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; BOS TAURUS BONE; TIN; BOS TAURUS TENDON 6; 6; 6; 6; 17; 17; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1158_574501b1-e11a-49eb-e053-2991aa0aabd2 48951-1158 HUMAN OTC DRUG Arnica Stannum Arnica Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; ARNICA MONTANA; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; BOS TAURUS BONE; TIN; BOS TAURUS TENDON 6; 6; 6; 6; 17; 17; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1160_d90729b8-1a01-4727-9ea5-1bcd355a53f2 48951-1160 HUMAN OTC DRUG Arsenicum album 30 Special Order Arsenicum album 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE 30 [hp_X]/mL N 20181231 48951-1161_5745be85-b0fd-1972-e053-2a91aa0afc09 48951-1161 HUMAN OTC DRUG Arsenicum album 30 Arsenicum album 30 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE 30 [hp_X]/1 N 20181231 48951-1162_02cf3372-d255-4ee7-b13d-97a6212af9e0 48951-1162 HUMAN OTC DRUG Arsenicum album 6 Special Order Arsenicum album 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE 6 [hp_X]/mL N 20181231 48951-1163_549e0b36-7041-0f5d-e054-00144ff88e88 48951-1163 HUMAN OTC DRUG Arsenicum Cerebrum Arsenicum Cerebrum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT; BOS TAURUS FRONTAL LOBE; BOS TAURUS BRAIN; SUS SCROFA TEMPORAL LOBE; SILVER SULFIDE; ARSENIC TRIOXIDE 6; 8; 8; 8; 20; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1164_5745837d-c408-757d-e053-2a91aa0a5255 48951-1164 HUMAN OTC DRUG Arsenicum Cerebrum Arsenicum Cerebrum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT; BOS TAURUS FRONTAL LOBE; BOS TAURUS BRAIN; ANTIMONY PENTASULFIDE; ARSENIC TRIOXIDE 6; 8; 8; 20; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1167_39448043-f5b4-4df9-bf0f-09ba8e07a3d7 48951-1167 HUMAN OTC DRUG Articulatio Coxae 8 Articulatio Coxae 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 8 [hp_X]/mL N 20181231 48951-1168_84b15eec-8eaa-4f21-90d0-a01ff1899527 48951-1168 HUMAN OTC DRUG Articulatio genus 8 Articulatio genus 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 8 [hp_X]/mL N 20181231 48951-1169_cb24aaa1-8520-46fd-afcb-893be6dc8f8a 48951-1169 HUMAN OTC DRUG Articulatio humeri 6 Special Order Articulatio humeri 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS JOINT CAPSULE 6 [hp_X]/mL N 20181231 48951-1170_6b773b14-dbeb-461a-838d-600e2c7a52bc 48951-1170 HUMAN OTC DRUG Articulatio interphalangea 17 Special Order Articulatio interphalangea 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 17 [hp_X]/mL N 20181231 48951-1171_56e09ff3-8633-2309-e054-00144ff8d46c 48951-1171 HUMAN OTC DRUG Astragalus Arnica Astragalus Arnica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASTRAGALUS PROPINQUUS ROOT; ARNICA MONTANA 3; 30 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1172_89b9af2b-a923-4e7c-a5db-b77488b36f3c 48951-1172 HUMAN OTC DRUG Astragalus e rad. 1% Astragalus e rad. 1% LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASTRAGALUS PROPINQUUS ROOT 2 [hp_X]/mL N 20181231 48951-1173_5561d412-8bfc-7020-e054-00144ff88e88 48951-1173 HUMAN OTC DRUG Astragalus e rad. 3 Astragalus e rad. 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ASTRAGALUS PROPINQUUS ROOT 3 [hp_X]/mL N 20181231 48951-1174_55620881-b173-6785-e054-00144ff8d46c 48951-1174 HUMAN OTC DRUG Astragalus Formica Astragalus Formica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; ASTRAGALUS PROPINQUUS ROOT; FORMICA RUFA; SILVER 3; 3; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1175_06bf7416-0111-400d-912f-da372ad4d032 48951-1175 HUMAN OTC DRUG Aurum 12 Special Order Aurum 12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 12 [hp_X]/mL N 20181231 48951-1177_55625251-0a91-0b7b-e054-00144ff88e88 48951-1177 HUMAN OTC DRUG Aurum 20 Aurum 20 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 20 [hp_X]/mL N 20181231 48951-1178_55625251-0aa0-0b7b-e054-00144ff88e88 48951-1178 HUMAN OTC DRUG Aurum 30 Aurum 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 30 [hp_X]/mL N 20181231 48951-1180_5796be77-80d1-a137-e053-2a91aa0a0ae2 48951-1180 HUMAN OTC DRUG Aurum 5 Aurum 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 5 [hp_X]/g N 20181231 48951-1181_55625251-0aae-0b7b-e054-00144ff88e88 48951-1181 HUMAN OTC DRUG Aurum 6 Aurum 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 6 [hp_X]/mL N 20181231 48951-1182_56e0f939-7803-4f0d-e054-00144ff88e88 48951-1182 HUMAN OTC DRUG Aurum 6 Aurum 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 6 [hp_X]/mL N 20181231 48951-1184_55530a85-18e2-372a-e054-00144ff88e88 48951-1184 HUMAN OTC DRUG Aurum Crataegus Aurum Crataegus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TARAXACUM PALUSTRE ROOT; HAWTHORN LEAF WITH FLOWER; VALERIAN; SELENICEREUS GRANDIFLORUS STEM; CAMPHOR (NATURAL); STROPHANTHUS KOMBE WHOLE; GOLD 2; 3; 3; 4; 4; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1186_12c8f896-25eb-420f-88d7-990b6ba952af 48951-1186 HUMAN OTC DRUG Aurum Equisetum A Aurum Equisetum A LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; PORK KIDNEY; GOLD; EQUISETUM ARVENSE TOP 8; 8; 10; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1187_5745837d-c3fb-757d-e053-2a91aa0a5255 48951-1187 HUMAN OTC DRUG Aurum Equisetum A Aurum Equisetum A PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; PORK KIDNEY; GOLD; EQUISETUM ARVENSE TOP 8; 8; 10; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1188_54485f8a-6861-309f-e054-00144ff8d46c 48951-1188 HUMAN OTC DRUG Aurum Equisetum B Aurum Equisetum B LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; GOLD 17; 30 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1189_a8e0dcba-0a9d-409d-a588-251fee20f353 48951-1189 HUMAN OTC DRUG Aurum Equisetum B Aurum Equisetum B PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; GOLD 17; 30 [hp_X]/1; [hp_X]/1 N 20181231 48951-1190_544c80da-8f40-1e87-e054-00144ff8d46c 48951-1190 HUMAN OTC DRUG Aurum Hypericum Aurum Hypericum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AVENA SATIVA FLOWERING TOP; ST. JOHN'S WORT; MAMMAL LIVER; MAGNESIUM HYDROXIDE; PHOSPHORIC ACID; STRYCHNOS IGNATII SEED; ROYAL JELLY; GOLD TRICHLORIDE; SILICON DIOXIDE 3; 3; 4; 4; 5; 5; 6; 7; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1192_57455ed3-fe4a-4967-e053-2991aa0ac838 48951-1192 HUMAN OTC DRUG Aurum Hypericum Stibium Aurum Hypericum Stibium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; ST. JOHN'S WORT; ANTIMONY 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1194_823ff8c0-4194-11df-9879-0800200c9a66 48951-1194 HUMAN OTC DRUG Aurum Lavender Rose HORSE CHESTNUT EQUISETUM ARVENSE TOP HYPERICUM PERFORATUM GOLD MYRRH CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc HORSE CHESTNUT; EQUISETUM ARVENSE TOP; HYPERICUM PERFORATUM; GOLD; MYRRH 2; 2; 3; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1195_de80e65b-1cca-4b7c-b257-5d13251913f6 48951-1195 HUMAN OTC DRUG Aurum Lavender Rose Aurum Lavender Rose OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; EQUISETUM ARVENSE TOP; ST. JOHN'S WORT; MYRRH; FRANKINCENSE; GOLD 3; 3; 2; 10; 10; 13 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1196_555319ab-fcf2-18d6-e054-00144ff8d46c 48951-1196 HUMAN OTC DRUG Aurum Olibanum Myrrha Aurum Olibanum Myrrha LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MYRRH; FRANKINCENSE; GOLD 7; 7; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1198_54c2a982-116e-16bb-e054-00144ff88e88 48951-1198 HUMAN OTC DRUG Threefold Balance Threefold Balance TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FRANKINCENSE; MYRRH; GOLD 2; 2; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1199_55533c33-46fb-449e-e054-00144ff88e88 48951-1199 HUMAN OTC DRUG Aurum Onopordon Aurum Onopordon LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; ARNICA MONTANA; GOLD; FORMICA RUFA 2; 2; 4; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1200_555331cb-8a6f-47e9-e054-00144ff88e88 48951-1200 HUMAN OTC DRUG Aurum Plumbum Aurum Plumbum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; GOLD; LEAD; HONEY 10; 10; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1201_57455ed3-fe3c-4967-e053-2991aa0ac838 48951-1201 HUMAN OTC DRUG Aurum Plumbum Aurum Plumbum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; GOLD; LEAD 10; 10; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1202_555331cb-8a7d-47e9-e054-00144ff88e88 48951-1202 HUMAN OTC DRUG Aurum Prunus Aurum Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE; GOLD 6; 10 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1203_56e1ab18-d9a2-62ee-e054-00144ff88e88 48951-1203 HUMAN OTC DRUG Aurum Prunus Aurum Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE; GOLD 6; 10 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1204_574693ca-46c2-a8c9-e053-2a91aa0a1ec6 48951-1204 HUMAN OTC DRUG Aurum Prunus Aurum Prunus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE; GOLD 6; 10 [hp_X]/1; [hp_X]/1 N 20181231 48951-1205_549e0607-d311-6b7e-e054-00144ff8d46c 48951-1205 HUMAN OTC DRUG Aurum Stibium Hyoscyamus Aurum Stibium Hyoscyamus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; ANTIMONY; GOLD 3; 3; 4; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1206_56e1ab18-d995-62ee-e054-00144ff88e88 48951-1206 HUMAN OTC DRUG AURUM STIBIUM HYOSCYAMUS AURUM STIBIUM HYOSCYAMUS LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC URIEL PHARMACY INC. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; ANTIMONY; GOLD 3; 3; 4; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1207_57468825-f749-5b08-e053-2991aa0a10fd 48951-1207 HUMAN OTC DRUG Aurum Stibium Hyocyamus Aurum Stibium Hyocyamus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PRIMULA VERIS FLOWER; ONOPORDUM ACANTHIUM FLOWER; HYOSCYAMUS NIGER LEAF; ANTIMONY; GOLD 3; 3; 4; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1208_574675b1-a44d-4459-e053-2991aa0ae5b3 48951-1208 HUMAN OTC DRUG Aurum Stibium Special Order Aurum Stibium Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; GOLD 8; 10 [hp_X]/1; [hp_X]/1 N 20181231 48951-1209_55534081-1439-496b-e054-00144ff88e88 48951-1209 HUMAN OTC DRUG Aurum Strophanthus Aurum Strophanthus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STROPHANTHUS KOMBE WHOLE; GOLD 6; 12 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1210_5746522f-a529-d78c-e053-2a91aa0a49c8 48951-1210 HUMAN OTC DRUG Aurum Strophanthus Special Order Aurum Strophanthus Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STROPHANTHUS KOMBE WHOLE; SILVER 6; 12 [hp_X]/1; [hp_X]/1 N 20181231 48951-1211_4786bc9e-366e-4435-b523-ab477450c70c 48951-1211 HUMAN OTC DRUG Avena Valeriana Avena Valeriana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AVENA SATIVA FLOWERING TOP; OSTREA EDULIS SHELL; VALERIAN; PHOSPHORUS; SULFUR 6; 7; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1212_daa2ab02-a3a0-4940-99d4-d130fd8f6998 48951-1212 HUMAN OTC DRUG Avena Valeriana Nerve Relief OAT VALERIAN ROOT OYSTER SHELL CALCIUM CARBONATE, CRUDE PHOSPHORUS SULFUR PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc OAT; VALERIAN ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SULFUR 3; 3; 7; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1213_76d68e05-4d4b-4d49-86b9-53a944f2683b 48951-1213 HUMAN OTC DRUG Arnica Rosa Arnica Rosa LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NERVE; BOS TAURUS EYE; BOS TAURUS BRAIN; ARNICA MONTANA; COLLOIDAL SILICON DIOXIDE 6; 6; 7; 17; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1214_5447dac6-6db8-3c5f-e054-00144ff88e88 48951-1214 HUMAN OTC DRUG Apis Belladonna Mercurius Apis Belladonna Mercurius LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; APIS MELLIFERA; MERCURIUS SOLUBILIS 4; 5; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1215_56dfe635-8983-6b22-e054-00144ff8d46c 48951-1215 HUMAN OTC DRUG Argentum Bryophyllum Special Order Argentum Bryophyllum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; SILVER 6; 10 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1216_56e09ff3-8640-2309-e054-00144ff8d46c 48951-1216 HUMAN OTC DRUG Aurum 17 Special Order Aurum 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 17 [hp_X]/mL N 20181231 48951-1217_56dfe635-89ba-6b22-e054-00144ff8d46c 48951-1217 HUMAN OTC DRUG Apis Belladonna Special Order Apis Belladonna Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA 3; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1218_914c9834-8883-4612-80c7-f1e6d9e7fbfb 48951-1218 HUMAN OTC DRUG Arnica Nettle Burn and Bite Special Order Arnica Nettle Burn and Bite Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. URTICA URENS; ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; LARIX DECIDUA RESIN; THUJA OCCIDENTALIS WHOLE; COMFREY ROOT; LYTTA VESICATORIA; SILVER 1; 1; 2; 2; 2; 2; 7; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1219_5708e37c-fc92-1953-e054-00144ff8d46c 48951-1219 HUMAN OTC DRUG Agaricus muscarius 30 Special Order Agaricus muscarius 30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMANITA MUSCARIA FRUITING BODY 30 [hp_X]/1 N 20181231 48951-1220_9fb97589-ee90-4f64-890f-721ca7ee7991 48951-1220 HUMAN OTC DRUG Argentite Urtica Special Order Argentite Urtica Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SAW PALMETTO; URTICA DIOICA; ROYAL JELLY; SILVER SULFIDE; BOS TAURUS PITUITARY GLAND; BOS TAURUS TESTICLE 4; 4; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1221_57e6e5d4-9c62-a0d4-e053-2991aa0ae2b3 48951-1221 HUMAN OTC DRUG Argentum 0.4 Adult Size (cocoa butter) Special Order Argentum 0.4 Adult Size (cocoa butter) Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 1 [hp_X]/g N 20181231 48951-1222_553bf80d-170d-606b-e054-00144ff88e88 48951-1222 HUMAN OTC DRUG Agaricus Equisetum Special Order Agaricus Equisetum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DRYOPTERIS FILIX-MAS ROOT; EQUISETUM ARVENSE TOP; SILICON DIOXIDE; SILVER FLUORIDE; OSTREA EDULIS SHELL; PHOSPHORUS; AMANITA MUSCARIA FRUITING BODY; LEAD; HONEY 3; 4; 4; 6; 6; 6; 8; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1223_56dfe635-899f-6b22-e054-00144ff8d46c 48951-1223 HUMAN OTC DRUG Apis Bryonia Special Order Apis Bryonia Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BRYONIA ALBA ROOT 3; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1224_f32bdc5c-8ad9-489f-b73b-c133d1c80c5f 48951-1224 HUMAN OTC DRUG Astragalus Formica Special Order Astragalus Formica Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; ASTRAGALUS PROPINQUUS ROOT; FORMICA RUFA; SILVER 3; 3; 6; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1225_0a17b1f2-6b6d-4c97-ae1d-b85f461178cb 48951-1225 HUMAN OTC DRUG Argentum 8 Special Order Argentum 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 8 [hp_X]/1 N 20181231 48951-1226_eaec21ae-143c-43a6-a324-0a38b02991d9 48951-1226 HUMAN OTC DRUG Apis Eucalyptus Special Order Apis Eucalyptus Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; EUCALYPTUS GUM 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1227_d68c26f9-2fb6-4eb9-bc8f-5617529b183e 48951-1227 HUMAN OTC DRUG Arnica Apis Nervus trigeminus Special Order Arnica Apis Nervus trigeminus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NERVE; ARNICA MONTANA; APIS MELLIFERA 10; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1228_553f8af1-436a-7247-e054-00144ff8d46c 48951-1228 HUMAN OTC DRUG Arnica Aurum 15/10 Special Order Arnica Aurum 15/10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; ARNICA MONTANA 10; 15 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1229_0a22df6d-972c-4ae0-a081-e5f375c38764 48951-1229 HUMAN OTC DRUG Aurum 30 Special Order Aurum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD 30 [hp_X]/mL N 20181231 48951-1230_55629855-d1a1-0d66-e054-00144ff8d46c 48951-1230 HUMAN OTC DRUG Aurum Hypericum Stibium Special Order Aurum Hypericum Stibium Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; ST. JOHN'S WORT; ANTIMONY 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1231_a5e7571c-c260-44df-8389-332562c3e9ca 48951-1231 HUMAN OTC DRUG Arnica Carbo Special Order Arnica Carbo Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT; ATROPA BELLADONNA; MELILOTUS INDICUS SEED; ACTIVATED CHARCOAL; LACHESIS MUTA VENOM 6; 6; 8; 10; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1232_0d4b4781-4fea-4823-8254-4b6d45d63567 48951-1232 HUMAN OTC DRUG Argentum Vesica urinaria 8/5 Special Order Argentum Vesica urinaria 8/5 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA URINARY BLADDER; SILVER 5; 8 [hp_X]/mL; 1/mL N 20181231 48951-1233_554f5fca-f049-2c78-e054-00144ff88e88 48951-1233 HUMAN OTC DRUG Arnica Aurum 3/30 Special Order Arnica Aurum 3/30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; GOLD 3; 30 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1234_d54cbdfa-b2dc-4d72-b7d9-e34bf7aa26d9 48951-1234 HUMAN OTC DRUG Argentum carbonicum 6 Special Order Argentum carbonicum 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER CARBONATE 6 [hp_X]/mL N 20181231 48951-1235_b7bee05c-ed34-489c-afa8-7efe971e9435 48951-1235 HUMAN OTC DRUG Apis ex animale 4 Special Order Apis ex animale 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 4 [hp_X]/mL N 20181231 48951-1236_ec38f1ac-6c97-4502-adab-4f0b6c996f12 48951-1236 HUMAN OTC DRUG Aconitum e tub. 6 Special Order Aconitum e tub. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS 6 [hp_X]/mL N 20181231 48951-1237_553c8cfa-cf05-0b1f-e054-00144ff88e88 48951-1237 HUMAN OTC DRUG Apis ex animale 3 Special Order Apis ex animale 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 3 [hp_X]/mL N 20181231 48951-1238_e9cfc22c-89a2-4afb-916b-75698ba5830b 48951-1238 HUMAN OTC DRUG Argentum nitricum 6 Special Order Argentum nitricum 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER 6 [hp_X]/mL N 20181231 48951-1239_0cad9075-7160-4c26-a523-ba025fdc8af4 48951-1239 HUMAN OTC DRUG Archangelica 3 Special Order Archangelica 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANGELICA ARCHANGELICA ROOT 3 [hp_X]/mL N 20181231 48951-1240_200b5ad6-de7c-4be8-8684-35bc6b36e17e 48951-1240 HUMAN OTC DRUG Absinthium ex herba 1 Special Order Absinthium ex herba 1 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. WORMWOOD 2 [hp_X]/mL N 20181231 48951-1241_d2c2886a-e690-4964-b167-ec2551b4840e 48951-1241 HUMAN OTC DRUG Antimonite Echincea Special Order Antimonite Echincea Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; BOS TAURUS OVARY; BEEF; SUS SCROFA FALLOPIAN TUBE; ANTIMONY TRISULFIDE 3; 6; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1242_5708fa75-f82e-203f-e054-00144ff8d46c 48951-1242 HUMAN OTC DRUG Apis Phosphorus Special Order Apis Phosphorus Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; SILVER SULFIDE; PHOSPHORUS 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1243_57fc308f-0228-b229-e053-2a91aa0a44e8 48951-1243 HUMAN OTC DRUG Aurum Stibium Special Order Aurum Stibium Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COMFREY ROOT; GOLD 8; 10 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1244_d10bd1ca-fd5f-4d01-8f4e-854ae044c16b 48951-1244 HUMAN OTC DRUG Aesculinum 30 Special Order Aesculinum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ESCULIN 30 [hp_X]/mL N 20181231 48951-1245_62111f3e-e3d4-478d-9cd5-522351137523 48951-1245 HUMAN OTC DRUG Arnica Stannum Special Order Arnica Stannum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; ARNICA MONTANA; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; BOS TAURUS BONE; TIN; BOS TAURUS TENDON 6; 6; 6; 6; 17; 17; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1247_57fc1cf7-140b-f841-e053-2991aa0a31c1 48951-1247 HUMAN OTC DRUG Aurum Ferrum sidereum 10/10 Special Order Aurum Ferrum sidereum 10/10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; IRON 10; 10 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1248_1d9aea5d-d995-4d1a-83bf-83dbb09291ce 48951-1248 HUMAN OTC DRUG Arnica Calendula Special Order Arnica Calendula Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; COLLOIDAL SILICON DIOXIDE; ANTIMONY 1; 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1249_dbd15d60-6475-4ae5-b675-22e6b522ccde 48951-1249 HUMAN OTC DRUG Aconitum e tub. 30 Special Order Aconitum e tub. 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS 30 [hp_X]/mL N 20181231 48951-1250_55627e32-e77b-0a09-e054-00144ff88e88 48951-1250 HUMAN OTC DRUG Aurum Equisetum 10/15 Special Order Aurum Equisetum 10/15 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; EQUISETUM ARVENSE TOP 10; 15 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1251_39ada185-e66a-454a-86f2-a136aba56d9d 48951-1251 HUMAN OTC DRUG Apis ex animale 20 Special Order Apis ex animale 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 20 [hp_X]/mL N 20181231 48951-1252_2e441193-e147-4545-af30-8cdd7a136263 48951-1252 HUMAN OTC DRUG Arnica Retina Quartz Special Order Arnica Retina Quartz Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; BOS TAURUS EYE; COLLOIDAL SILICON DIOXIDE; ARNICA MONTANA; EQUISETUM ARVENSE TOP 10; 10; 12; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1253_710a1125-9ee1-42eb-8d4c-3c7976a35694 48951-1253 HUMAN OTC DRUG Achillea Millefolium 10 Special Order Achillea Millefolium 10 Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACHILLEA MILLEFOLIUM 1 [hp_X]/g N 20181231 48951-1255_d993ee00-a601-454c-9985-f5c6b68f6130 48951-1255 HUMAN OTC DRUG Aconitum e tub. 6 Special Order Aconitum e tub. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS 6 [hp_X]/mL N 20181231 48951-1256_791f82e4-a93c-4562-bc23-404b3dca16b7 48951-1256 HUMAN OTC DRUG Allium Cuprum comp. Special Order Allium Cuprum comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; GARLIC; CUPRIC SULFATE 2; 2; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1257_126b6f08-531a-453b-9224-6a4622385f0d 48951-1257 HUMAN OTC DRUG Apis ex animale 30 Special Order Apis ex animale 30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA 30 [hp_X]/1 N 20181231 48951-1258_35b80602-d2eb-4426-9240-6d622c0d54d1 48951-1258 HUMAN OTC DRUG Arnica Echinacea Special Order Arnica Echinacea Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA LEAF; ST. JOHN'S WORT; ACONITUM NAPELLUS; ACHILLEA MILLEFOLIUM; ARNICA MONTANA; ATROPA BELLADONNA; MATRICARIA RECUTITA; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; COMFREY ROOT 3; 3; 3; 7; 7; 7; 7; 8; 8; 8; 8; 8; 11; 11; 11 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1259_ade091de-be74-4c21-a30d-c38dda9500e0 48951-1259 HUMAN OTC DRUG Arsenicum Cerebrum Special Order Arsenicum Cerebrum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA ROOT; BOS TAURUS FRONTAL LOBE; BOS TAURUS BRAIN; SUS SCROFA TEMPORAL LOBE; SILVER SULFIDE; ARSENIC TRIOXIDE 6; 8; 8; 8; 20; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1260_789dea19-ec15-48eb-b185-25a2c3e84b05 48951-1260 HUMAN OTC DRUG Artemesia absinthium 5 Special Order Artemesia absinthium 5 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. WORMWOOD 1 [hp_X]/mL N 20181231 48951-1261_91b900e3-ebfc-4d06-ba09-af9001ec6e6c 48951-1261 HUMAN OTC DRUG Arum maculatum Pteridium 5/5 Special Order Arum maculatum Pteridium 5/5 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARUM MACULATUM ROOT; PTERIDIUM AQUILINUM WHOLE 5; 5 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1262_f1ff416b-0567-4259-a0fc-5856b7ab0238 48951-1262 HUMAN OTC DRUG Aurum Belladonna Special Order Aurum Belladonna Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MYRRH; FRANKINCENSE; ATROPA BELLADONNA; GOLD 7; 7; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1263_18ea4f41-5da9-42a0-a7bd-2e92643b05eb 48951-1263 HUMAN OTC DRUG Aconitum Bryonia Child Size Special Order Aconitum Bryonia Child Size Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA; ATROPA BELLADONNA; QUILLAJA SAPONARIA BARK; EUCALYPTUS GUM; EUPATORIUM CANNABINUM; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; SILVER 2; 3; 4; 4; 4; 5; 5; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1264_55526532-28ef-6fb3-e054-00144ff8d46c 48951-1264 HUMAN OTC DRUG Arsenicum album 8 Special Order Arsenicum album 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARSENIC TRIOXIDE 8 [hp_X]/mL N 20181231 48951-1265_f248f845-9d65-49c7-ac87-556dd9ebfab2 48951-1265 HUMAN OTC DRUG Ananassa Arnica Ananassa Arnica CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PINEAPPLE; LARIX DECIDUA RESIN; ARNICA MONTANA FLOWER; COLLOIDAL SILICON DIOXIDE 2; 2; 2; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1266_ac7f722b-da39-4d39-a21f-aa0dc679cc75 48951-1266 HUMAN OTC DRUG Aurum Stibium Special Order Aurum Stibium Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY; GOLD 8; 10 [hp_X]/mL; [hp_X]/mL N 20181231 48951-1267_4c1fdc15-a4c8-4036-8fe5-d3115eebcfc7 48951-1267 HUMAN OTC DRUG Arnica e pl. tota 10 Arnica e pl. tota 10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 10 [hp_X]/mL N 20181231 48951-1268_8348fb19-7bea-4ee8-9b85-c977fd6a9b43 48951-1268 HUMAN OTC DRUG Archangelica Eucalyptus DKS Special Order Archangelica Eucalyptus DKS Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANGELICA ARCHANGELICA ROOT; PLANTAGO MAJOR LEAF; CAMPHOR (NATURAL); GOLD; MERCURY; ROSMARINUS OFFICINALIS FLOWERING TOP 1; 4; 6; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1269_3a02c3cc-1530-41af-be40-4fdeea605805 48951-1269 HUMAN OTC DRUG Argentum 5 DKS Special Order Argentum 5 DKS Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; BERBERIS VULGARIS ROOT BARK 5; 6 [hp_X]/g; [hp_X]/g N 20181231 48951-1270_40573922-bdf8-2962-e054-00144ff8d46c 48951-1270 HUMAN OTC DRUG Amber Amethyst Amber Amethyst CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; EQUISETUM ARVENSE TOP; AMBER; SILICON DIOXIDE 2; 2; 3; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1271_5438c524-8544-25d6-e054-00144ff88e88 48951-1271 HUMAN OTC DRUG Amethyst Rosa Amethyst Rosa CAPSULE ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILICON DIOXIDE; ACTIVATED CHARCOAL; FUMARIA OFFICINALIS FLOWERING TOP; WORMWOOD; BETULA PUBESCENS LEAF; ACORUS CALAMUS ROOT; MATRICARIA RECUTITA; COCHLEARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GEUM URBANUM ROOT; OXALIS ACETOSELLA LEAF; ROSA RUGOSA FLOWER BUD; URTICA DIOICA LEAF; URTICA DIOICA ROOT; GINGER; ANTIMONY TRISULFIDE; BLACK PEPPER; FERRIC OXIDE RED; GRAPHITE 2; 2; 3; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 5; 5; 6; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1273_54c2f487-75b1-602f-e054-00144ff8d46c 48951-1273 HUMAN OTC DRUG Apis Belladonna Apis Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ATROPA BELLADONNA; APIS MELLIFERA 4; 5 [hp_X]/1; [hp_X]/1 N 20181231 48951-1274_54c1984f-4107-6761-e054-00144ff88e88 48951-1274 HUMAN OTC DRUG Argentum Calendula Argentum Calendula OINTMENT VAGINAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP; SLOE; SILVER; BOS TAURUS OVARY 1; 2; 3; 7 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-1275_54c33967-4b25-1617-e054-00144ff88e88 48951-1275 HUMAN OTC DRUG Apis Levisticum Apis Levisticum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc APIS MELLIFERA; LEVISTICUM OFFICINALE LEAF 3; 3 [hp_X]/1; [hp_X]/1 N 20181231 48951-1276_54c33967-4b3a-1617-e054-00144ff88e88 48951-1276 HUMAN OTC DRUG Aquavit Aquavit LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ANISE; ANGELICA ARCHANGELICA ROOT; BLACK PEPPER; PRUNUS SPINOSA BUDDING TOP; CALENDULA OFFICINALIS FLOWERING TOP; CARAWAY SEED; MATRICARIA RECUTITA; GINGER; EQUISETUM ARVENSE TOP; JUNIPER BERRY; ORIGANUM MAJORANA; MELISSA OFFICINALIS; ROSE PETAL EXTRACT; ROSEMARY; SAGE; GOLD; HYPERICUM PERFORATUM; CINCHONA OFFICINALIS BARK 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 3; 3; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1277_54c38462-ff70-32aa-e054-00144ff88e88 48951-1277 HUMAN OTC DRUG Arnica Echinacea Arnica Echinacea PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ST. JOHN'S WORT; ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; COMFREY ROOT 5; 5; 5; 5; 6; 6; 6; 6; 6; 6; 9; 9; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1278_54c3c15d-f38d-6fb9-e054-00144ff8d46c 48951-1278 HUMAN OTC DRUG Aurum Crataegus Aurum Crataegus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc TARAXACUM OFFICINALE; HAWTHORN LEAF WITH FLOWER; VALERIAN; SELENICEREUS GRANDIFLORUS STEM; CAMPHOR (SYNTHETIC); STROPHANTHUS HISPIDUS SEED; GOLD 2; 3; 3; 4; 4; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1279_54c3c15d-f39e-6fb9-e054-00144ff8d46c 48951-1279 HUMAN OTC DRUG Avena Valeriana Avena Valeriana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc AVENA SATIVA FLOWERING TOP; VALERIAN; OSTREA EDULIS SHELL; PHOSPHORUS; SULFUR 3; 3; 7; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1280_55117ea3-0549-61f7-e054-00144ff88e88 48951-1280 HUMAN OTC DRUG Threefold Balance Threefold Balance PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc MYRRH; GOLD 7; 10 [hp_X]/1; [hp_X]/1 N 20181231 48951-1281_5512778c-1e0b-4545-e054-00144ff8d46c 48951-1281 HUMAN OTC DRUG Aurum Hypericum Aurum Hypericum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc OAT; HYPERICUM PERFORATUM; PHOSPHORIC ACID; STRYCHNOS IGNATII SEED; MAMMAL LIVER; MAGNESIUM; APIS MELLIFERA; SILICON DIOXIDE; GOLD TRICHLORIDE 3; 3; 5; 5; 5; 5; 6; 7; 7 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-1282_553dd6db-30ae-3520-e054-00144ff88e88 48951-1282 HUMAN OTC DRUG Arnica Nettle Burn and Bite Arnica Nettle Burn and Bite SPRAY TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. URTICA URENS; ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWERING TOP; LARIX DECIDUA RESIN; THUJA OCCIDENTALIS WHOLE; COMFREY ROOT; LYTTA VESICATORIA; SILVER 1; 1; 2; 2; 2; 2; 7; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-1283_555079df-2958-23ab-e054-00144ff8d46c 48951-1283 HUMAN OTC DRUG Argentum Malachite Argentum Malachite CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AZADIRACHTA INDICA FLOWER; SILVER; CUPRIC CATION; MERCURY 2; 3; 3; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-2001_5796a492-88ea-9a53-e053-2a91aa0a8e96 48951-2001 HUMAN OTC DRUG Bamboo Rosemary Bamboo Rosemary CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROSEMARY OIL; BAMBUSA VULGARIS WHOLE; EQUISETUM ARVENSE TOP; VISCUM ALBUM FRUITING TOP; BOS TAURUS INTERVERTEBRAL DISC; FORMICA RUFA; TIN 2; 3; 3; 3; 5; 5; 7 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-2002_55534081-1446-496b-e054-00144ff88e88 48951-2002 HUMAN OTC DRUG Bambusa Aesculus Bambusa Aesculus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; BOS TAURUS INTERVERTEBRAL DISC; SILICON DIOXIDE; ARNICA MONTANA; HORSE CHESTNUT 6; 6; 6; 7; 8; 12; 20; 50 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2003_57d20260-e824-55bf-e053-2991aa0a0287 48951-2003 HUMAN OTC DRUG BAMBUSA AESCULUS BAMBUSA AESCULUS GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC URIEL PHARMACY INC. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; BOS TAURUS INTERVERTEBRAL DISC; SILICON DIOXIDE; ARNICA MONTANA; HORSE CHESTNUT 6; 6; 6; 7; 8; 12; 20; 50 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-2004_574675b1-a442-4459-e053-2991aa0ae5b3 48951-2004 HUMAN OTC DRUG Bambusa Aesculus Bambusa Aesculus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; BOS TAURUS INTERVERTEBRAL DISC; SILICON DIOXIDE; ARNICA MONTANA; HORSE CHESTNUT 6; 6; 6; 7; 8; 12; 20; 50 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2005_5562f963-1ed1-26ea-e054-00144ff88e88 48951-2005 HUMAN OTC DRUG Bambusa Argentum Bambusa Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; BOS TAURUS INTERVERTEBRAL DISC; SILICON DIOXIDE; SILVER; ARNICA MONTANA 6; 6; 6; 7; 8; 17; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2006_5b6d9354-fe13-474d-a152-382a149621be 48951-2006 HUMAN OTC DRUG Bambusa Argentum Bambusa Argentum GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; ROSMARINUS OFFICINALIS FLOWERING TOP; GOLD; BOS TAURUS INTERVERTEBRAL DISC; COPPER; COLLOIDAL SILICON DIOXIDE; SILVER; ARNICA MONTANA 8; 8; 8; 9; 10; 11; 19; 22; 22 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-2007_4cd01554-db7b-49b9-84be-f8cca6c35fbb 48951-2007 HUMAN OTC DRUG Bambusa Argentum Bambusa Argentum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; BOS TAURUS INTERVERTEBRAL DISC; COLLOIDAL SILICON DIOXIDE; SILVER; ARNICA MONTANA 6; 6; 6; 7; 8; 17; 20; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2009_5746522f-a4d7-d78c-e053-2a91aa0a49c8 48951-2009 HUMAN OTC DRUG Bambusa Aurum Bambusa Aurum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; BOS TAURUS INTERVERTEBRAL DISC; ROSMARINUS OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; GOLD; ARNICA MONTANA 5; 6; 6; 6; 6; 12; 16; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2010_651d5692-230f-4c24-9f1b-318bcd068ce9 48951-2010 HUMAN OTC DRUG Bambusa Formica Bambusa Formica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MYRRH; FRANKINCENSE; BOS TAURUS CEREBELLUM; COLLOIDAL SILICON DIOXIDE; BOS TAURUS BRAIN; BOS TAURUS PITUITARY GLAND; BOS TAURUS EYE; SUS SCROFA THALAMUS; SILVER 7; 7; 8; 8; 8; 8; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2011_55629855-d1b2-0d66-e054-00144ff8d46c 48951-2011 HUMAN OTC DRUG Bambusa Nicotiana Bambusa Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; BOS TAURUS INTERVERTEBRAL DISC; BOS TAURUS PITUITARY GLAND; TOBACCO LEAF; TIN; SILICON DIOXIDE; EQUISETUM ARVENSE TOP 6; 6; 6; 7; 8; 8; 10; 10; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2013_5746c884-6d79-b4c8-e053-2991aa0ae2f4 48951-2013 HUMAN OTC DRUG Bambusa Nicotiana Bambusa Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; BOS TAURUS INTERVERTEBRAL DISC; BOS TAURUS PITUITARY GLAND; TOBACCO LEAF; TIN; SILICON DIOXIDE; EQUISETUM ARVENSE TOP 6; 6; 6; 7; 8; 8; 10; 10; 12; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2014_544b3867-fb5d-51c5-e054-00144ff8d46c 48951-2014 HUMAN OTC DRUG Bambusa Pulsatilla Bambusa Pulsatilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP; EQUISETUM ARVENSE TOP; FORMICA RUFA; PULSATILLA VULGARIS; BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; BOS TAURUS INTERVERTEBRAL DISC; ROSMARINUS OFFICINALIS FLOWERING TOP; TIN; FERROSOFERRIC PHOSPHATE; SILICON DIOXIDE 3; 5; 5; 5; 6; 6; 6; 6; 7; 7; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2015_5746c884-6d64-b4c8-e053-2991aa0ae2f4 48951-2015 HUMAN OTC DRUG Bambusa Pulsatilla Bambusa Pulsatilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP; EQUISETUM ARVENSE TOP; PULSATILLA VULGARIS; BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; BOS TAURUS INTERVERTEBRAL DISC; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; TIN; FERROSOFERRIC PHOSPHATE; SILICON DIOXIDE 3; 5; 5; 6; 6; 6; 6; 7; 7; 7; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2016_55630fd4-cce2-2b6e-e054-00144ff88e88 48951-2016 HUMAN OTC DRUG Bambusa Rhus Bambusa Rhus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GELSEMIUM SEMPERVIRENS ROOT; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; ACONITUM NAPELLUS; BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; MANDRAGORA OFFICINARUM ROOT; TOXICODENDRON PUBESCENS LEAF; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; BOS TAURUS INTERVERTEBRAL DISC; PENOXSULAM; SILICON DIOXIDE; SILVER; ARNICA MONTANA 4; 4; 6; 6; 6; 6; 6; 6; 7; 8; 10; 12; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2017_5746dd41-6f76-4d0c-e053-2991aa0a5e59 48951-2017 HUMAN OTC DRUG Bambusa Rhus Bambusa Rhus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GELSEMIUM SEMPERVIRENS ROOT; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; ACONITUM NAPELLUS; BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; MANDRAGORA OFFICINARUM ROOT; TOXICODENDRON PUBESCENS LEAF; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; BOS TAURUS INTERVERTEBRAL DISC; PENOXSULAM; SILICON DIOXIDE; SILVER; ARNICA MONTANA 4; 4; 6; 6; 6; 6; 6; 6; 7; 8; 10; 12; 20; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2018_556379ba-5508-385c-e054-00144ff88e88 48951-2018 HUMAN OTC DRUG Bambusa Stannum Bambusa Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; BOS TAURUS INTERVERTEBRAL DISC; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; TIN; SILICON DIOXIDE; EQUISETUM ARVENSE TOP 6; 6; 6; 6; 7; 7; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2019_5746dd41-6f69-4d0c-e053-2991aa0a5e59 48951-2019 HUMAN OTC DRUG Bambusa Stannum Bambusa Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; ROSMARINUS OFFICINALIS FLOWERING TOP; BOS TAURUS INTERVERTEBRAL DISC; FORMICA RUFA; TIN; SILICON DIOXIDE; EQUISETUM ARVENSE TOP 6; 6; 6; 6; 7; 7; 12; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2020_556379ba-5516-385c-e054-00144ff88e88 48951-2020 HUMAN OTC DRUG Bambusa Stibium Bambusa Stibium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; BOS TAURUS INTERVERTEBRAL DISC; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; ANTIMONY; SILICON DIOXIDE; ARNICA MONTANA 6; 6; 6; 6; 7; 8; 12; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2021_57468111-abb8-3ade-e053-2a91aa0af5ea 48951-2021 HUMAN OTC DRUG Bambusa Stibium Bambusa Stibium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; BOS TAURUS INTERVERTEBRAL DISC; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; ANTIMONY; SILICON DIOXIDE; ARNICA MONTANA 6; 6; 6; 6; 7; 8; 12; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2023_556379ba-5522-385c-e054-00144ff88e88 48951-2023 HUMAN OTC DRUG Bambusa Viscum Stannum Bambusa Viscum Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; BOS TAURUS INTERVERTEBRAL DISC; ROSMARINUS OFFICINALIS FLOWERING TOP; VISCUM ALBUM FRUITING TOP; TIN; SILICON DIOXIDE; EQUISETUM ARVENSE TOP 5; 6; 6; 6; 6; 6; 7; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2024_5746c884-6d55-b4c8-e053-2991aa0ae2f4 48951-2024 HUMAN OTC DRUG Bambusa Viscum Stannum Bambusa Viscum Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; BOS TAURUS INTERVERTEBRAL DISC; ROSMARINUS OFFICINALIS FLOWERING TOP; VISCUM ALBUM FRUITING TOP; TIN; SILICON DIOXIDE; EQUISETUM ARVENSE TOP 5; 6; 6; 6; 6; 6; 7; 12; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2027_57fa2c59-6170-68d6-e053-2a91aa0a38ff 48951-2027 HUMAN OTC DRUG Belladonna Betula Formica Belladonna Betula Formica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; ATROPA BELLADONNA; FORMICA RUFA 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2030_529ee179-efe3-459c-8248-47c017bc4114 48951-2030 HUMAN OTC DRUG Belladonna ex herba 30 Belladonna ex herba 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA 30 [hp_X]/mL N 20181231 48951-2031_571ae6c5-9c13-49f4-90cd-de18f6e1cfea 48951-2031 HUMAN OTC DRUG Belladonna ex herba 30 Special Order Belladonna ex herba 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA 30 [hp_X]/mL N 20181231 48951-2033_5563b6d4-3e58-402b-e054-00144ff88e88 48951-2033 HUMAN OTC DRUG Belladonna ex herba 6 Belladonna ex herba 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA 6 [hp_X]/mL N 20181231 48951-2034_56e10d0b-18b0-351a-e054-00144ff8d46c 48951-2034 HUMAN OTC DRUG Belladonna ex herba 6 Special Order Belladonna ex herba 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA 6 [hp_X]/mL N 20181231 48951-2035_5563b6d4-3e65-402b-e054-00144ff88e88 48951-2035 HUMAN OTC DRUG Berberis Aurum Berberis Aurum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; KALANCHOE DAIGREMONTIANA LEAF; URTICA URENS; STRYCHNOS IGNATII SEED; SEPIA OFFICINALIS JUICE; BOS TAURUS PLACENTA; GOLD 2; 3; 3; 4; 5; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2036_563b0fc7-e6fb-4b24-a5d2-0df3bef6bc8a 48951-2036 HUMAN OTC DRUG Berberis Aurum Special Order Berberis Aurum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; KALANCHOE DAIGREMONTIANA LEAF; URTICA URENS; STRYCHNOS IGNATII SEED; SEPIA OFFICINALIS JUICE; BOS TAURUS PLACENTA; GOLD 2; 3; 3; 4; 5; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2037_2e5df993-6dce-4752-86be-1c73e5b8e5a1 48951-2037 HUMAN OTC DRUG Berberis e fruct. 10% Special Order Berberis e fruct. 10% Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK 1 [hp_X]/g N 20181231 48951-2040_6f083a75-ce0f-4ce1-a2a1-bf868a4a24f2 48951-2040 HUMAN OTC DRUG Berberis e rad. 2 Special Order Berberis e rad. 2 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK 2 [hp_X]/mL N 20181231 48951-2042_549d7dee-b04d-7312-e054-00144ff88e88 48951-2042 HUMAN OTC DRUG Berberis Larix Berberis Larix LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACHILLEA MILLEFOLIUM; BERBERIS VULGARIS ROOT BARK; EQUISETUM ARVENSE TOP; LYTTA VESICATORIA; APIS MELLIFERA; FERROUS DISULFIDE; LARIX DECIDUA RESIN; SUS SCROFA URINARY BLADDER 3; 3; 3; 6; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2044_7b5159e5-c893-42f1-ae26-4a7e82f80d7a 48951-2044 HUMAN OTC DRUG Berberis Oxalis Berberis Oxalis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; OXALIS MONTANA LEAF; SAW PALMETTO; URTICA URENS; VISCUM ALBUM FRUITING TOP; MAGNESIUM SULFATE; BOS TAURUS PROSTATE GLAND; PENOXSULAM 2; 3; 3; 3; 4; 6; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2046_57e6bf49-41c3-0ed6-e053-2a91aa0a67e7 48951-2046 HUMAN OTC DRUG Berberis Populus Adult Size Berberis Populus Adult Size SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; POPULUS TREMULA WHOLE; SAW PALMETTO; URTICA URENS; LARIX DECIDUA RESIN; BLACK PEPPER 3; 3; 3; 3; 8; 17 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-2047_83b516de-d480-4f2d-98b3-ae85ab6a5070 48951-2047 HUMAN OTC DRUG Berberis Populus Berberis Populus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; POPULUS TREMULA WHOLE; SAW PALMETTO; URTICA URENS; LARIX DECIDUA RESIN; BLACK PEPPER 2; 3; 3; 3; 8; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2048_575847db-5973-56b1-e053-2991aa0ad814 48951-2048 HUMAN OTC DRUG Berberis Populus Berberis Populus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; POPULUS TREMULA WHOLE; SAW PALMETTO; URTICA URENS; LARIX DECIDUA RESIN; BLACK PEPPER 1; 3; 3; 3; 8; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2049_549d7dee-b05c-7312-e054-00144ff88e88 48951-2049 HUMAN OTC DRUG Berberis Prunus Berberis Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT; ECHINACEA ANGUSTIFOLIA; SLOE; BOS TAURUS NASAL MUCOSA; FERROSOFERRIC PHOSPHATE; SILVER; SILICON DIOXIDE 2; 2; 2; 6; 8; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2050_56e10d0b-18a2-351a-e054-00144ff8d46c 48951-2050 HUMAN OTC DRUG Berberis Prunus Berberis Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; SLOE; FERROSOFERRIC PHOSPHATE; SILVER; BOS TAURUS NASAL MUCOSA; SILICON DIOXIDE 2; 2; 2; 6; 8; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2052_1983313a-200b-4137-8cd2-2ee850c38c12 48951-2052 HUMAN OTC DRUG Berberis Pyrite Special Order Berberis Pyrite Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; SAGE; FERROUS DISULFIDE; MERCURIC SULFIDE 3; 3; 3; 8; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2053_575847db-59bb-56b1-e053-2991aa0ad814 48951-2053 HUMAN OTC DRUG Berberis Pyrite Berberis Pyrite PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; FERROUS DISULFIDE; SAGE; MERCURIC SULFIDE 3; 3; 3; 3; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2054_55639edf-80df-3d3d-e054-00144ff88e88 48951-2054 HUMAN OTC DRUG Berberis Quartz Berberis Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; BOS TAURUS NASAL MUCOSA; SILICON DIOXIDE 3; 7; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2055_575847db-59fb-56b1-e053-2991aa0ad814 48951-2055 HUMAN OTC DRUG BERBERIS QUARTZ BERBERIS QUARTZ PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC URIEL PHARMACY INC. BERBERIS VULGARIS ROOT BARK; BOS TAURUS NASAL MUCOSA; SILICON DIOXIDE 3; 7; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2056_55639edf-80ed-3d3d-e054-00144ff88e88 48951-2056 HUMAN OTC DRUG Berberis Urtica Berberis Urtica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; URTICA URENS 2; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-2057_5758fc0c-685f-9392-e053-2a91aa0a4775 48951-2057 HUMAN OTC DRUG Berberis Urtica Berberis Urtica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; URTICA URENS 1; 2 [hp_X]/1; [hp_X]/1 N 20181231 48951-2058_0270ab3d-7781-4d48-9391-bdc4ecf32805 48951-2058 HUMAN OTC DRUG Berberis Viscum Berberis Viscum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; OXALIS MONTANA LEAF; URTICA URENS; VISCUM ALBUM FRUITING TOP; MAGNESIUM SULFATE; BOS TAURUS OVARY; ALUMINUM OXIDE; BOS TAURUS UTERUS; PENOXSULAM 2; 3; 3; 4; 6; 6; 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2059_386d8c52-f466-4896-8991-c93a04bdf492 48951-2059 HUMAN OTC DRUG Berberis Viscum Berberis Viscum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; OXALIS MONTANA LEAF; URTICA URENS; VISCUM ALBUM FRUITING TOP; MAGNESIUM SULFATE; BOS TAURUS OVARY; ALUMINUM OXIDE; BOS TAURUS UTERUS; PENOXSULAM 1; 3; 3; 4; 6; 6; 6; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2062_57fc871f-c31d-da7b-e053-2991aa0a3280 48951-2062 HUMAN OTC DRUG Betonica Rosmarinus Betonica Rosmarinus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STACHYS OFFICINALIS; ROSMARINUS OFFICINALIS FLOWERING TOP 3; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-2063_55640c6f-5e6e-4394-e054-00144ff88e88 48951-2063 HUMAN OTC DRUG Betula Argentum Betula Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; FORMICA RUFA; SILVER; ARNICA MONTANA 3; 3; 3; 7; 8; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2064_5758d564-28ed-cdbd-e053-2991aa0a8a42 48951-2064 HUMAN OTC DRUG Betula Argentum Betula Argentum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; APIS MELLIFERA; FORMICA RUFA; SILVER; ARNICA MONTANA 1; 1; 6; 7; 8; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2068_55640cbe-7b69-48ba-e054-00144ff8d46c 48951-2068 HUMAN OTC DRUG Betula Spiraea Betula spiraea LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; FILIPENDULA ULMARIA ROOT; MANDRAGORA OFFICINARUM ROOT; LEAD; FORMICA RUFA; ARNICA MONTANA; EQUISETUM ARVENSE TOP 3; 3; 3; 4; 7; 10; 17; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2069_5758c657-7c84-57c6-e053-2a91aa0acff2 48951-2069 HUMAN OTC DRUG Betula Spiraea Betula Spiraea PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS BARK; BETULA PUBESCENS LEAF; FILIPENDULA ULMARIA ROOT; MANDRAGORA OFFICINARUM ROOT; LEAD SULFIDE; FORMICA RUFA; ARNICA MONTANA; EQUISETUM ARVENSE TOP 3; 3; 3; 4; 7; 10; 17; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2071_3fb529e0-0f4d-11df-8a39-0800200c9a66 48951-2071 HUMAN OTC DRUG Birch Juniper Rejuvenation BETULA PENDULA LEAF JUNIPERUS COMMUNIS FRUIT SYRUP ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc BETULA PENDULA LEAF; JUNIPERUS COMMUNIS FRUIT 1; 1 [hp_X]/1; [hp_X]/1 N 20181231 48951-2075_54c236ce-6948-06ef-e054-00144ff88e88 48951-2075 HUMAN OTC DRUG Borago Lavender cum Cupro Borago Lavender cum Cupro LOTION TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; BORAGE; MELILOTUS INDICUS WHOLE; CUPRIC SULFATE 20; 20; 13; 2 g/100g; g/100g; g/100g; [hp_X]/100g N 20181231 48951-2077_5c1a247e-aee6-4a4a-95af-2a1e4c460ce1 48951-2077 HUMAN OTC DRUG Borago Nicotiana Borago Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BORAGE; CENTAUREA BENEDICTA; HAMAMELIS VIRGINIANA LEAF; TOBACCO LEAF; ALUMINUM OXIDE; HORSE CHESTNUT; FERROUS ARSENATE 3; 3; 3; 6; 8; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2078_5758d564-28df-cdbd-e053-2991aa0a8a42 48951-2078 HUMAN OTC DRUG Borago Nicotiana Borago Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BORAGO OFFICINALIS WHOLE; CENTAUREA BENEDICTA; HAMAMELIS VIRGINIANA LEAF; TOBACCO LEAF; ALUMINUM OXIDE; HORSE CHESTNUT; FERROUS ARSENATE 3; 3; 3; 6; 8; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2079_56e10d0b-1895-351a-e054-00144ff8d46c 48951-2079 HUMAN OTC DRUG Breatheze Breatheze LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PAPRIKA; EUPHRASIA STRICTA; LONICERA DASYSTYLA FLOWER BUD; JUJUBE FRUIT; URTICA DIOICA ROOT; URTICA DIOICA LEAF 2; 2; 2; 2; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2080_4285d71e-98e2-4bc4-ad3c-d45b4dac8366 48951-2080 HUMAN OTC DRUG Bronchi 17 Special Order Bronchi 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF LUNG 17 [hp_X]/mL N 20181231 48951-2082_1e7d6a70-9c88-4156-bdc9-7676a0bbf805 48951-2082 HUMAN OTC DRUG Bryonia Apis Special Order Bryonia Apis Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; BRYONIA ALBA ROOT; PULSATILLA VULGARIS; APIS MELLIFERA; BOS TAURUS OVARY; SUS SCROFA FALLOPIAN TUBE 6; 6; 6; 8; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2083_5758ba85-e2e3-33c3-e053-2a91aa0ac620 48951-2083 HUMAN OTC DRUG Bryonia Apis Special Order Bryonia Apis Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; BRYONIA ALBA ROOT; PULSATILLA VULGARIS; APIS MELLIFERA; BOS TAURUS OVARY; SUS SCROFA FALLOPIAN TUBE 6; 6; 6; 8; 20; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2084_12742f30-e03b-11de-8a39-0800200c9a66 48951-2084 HUMAN OTC DRUG Bryonia Eucalyptus Flu Relief ACONITUM NAPELLUS ROOT BRYONIA CRETICA SUBSP. DIOICA ROOT EUPATORIUM CANNABINUM WHOLE FLOWERING CINCHONA OFFICINALIS BARK EUCALYPTUS GLOBULUS LEAF PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ACONITUM NAPELLUS ROOT; BRYONIA CRETICA SUBSP. DIOICA ROOT; EUPATORIUM CANNABINUM WHOLE FLOWERING; CINCHONA OFFICINALIS BARK; EUCALYPTUS GLOBULUS LEAF 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2085_56e23999-273d-682a-e054-00144ff8d46c 48951-2085 HUMAN OTC DRUG Bryonia Spongia Bryonia Spongia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; SPONGIA OFFICINALIS WHOLE 4; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2086_544ddf40-c763-564c-e054-00144ff8d46c 48951-2086 HUMAN OTC DRUG Bryonia Stannum Bryonia Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; TIN 3; 17 [hp_X]/mL; [hp_X]/mL N 20181231 48951-2087_5759461e-4c3d-34ea-e053-2991aa0abffa 48951-2087 HUMAN OTC DRUG Bryonia Stannum Bryonia Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; TIN 3; 17 [hp_X]/1; [hp_X]/1 N 20181231 48951-2088_544c80da-8f4c-1e87-e054-00144ff8d46c 48951-2088 HUMAN OTC DRUG Bryophyllum Argentum Bryophyllum Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; SILVER; BOS TAURUS UTERUS 3; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2089_5758c657-7c78-57c6-e053-2a91aa0acff2 48951-2089 HUMAN OTC DRUG Bryophyllum Argentum Bryophyllum Argentum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; SILVER; BOS TAURUS UTERUS 3; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2090_5564471c-c17a-55d3-e054-00144ff8d46c 48951-2090 HUMAN OTC DRUG Bryophyllum Avena Bryophyllum Avena LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; AVENA SATIVA FLOWERING TOP; OSTREA EDULIS SHELL; VALERIAN; PHOSPHORUS; SULFUR 3; 6; 7; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2091_5c17bd20-06ae-11df-8a39-0800200c9a66 48951-2091 HUMAN OTC DRUG Bryophyllum Avena Tension Relief OAT VALERIAN ROOT OYSTER SHELL CALCIUM CARBONATE, CRUDE PHOSPHORUS SULFUR LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc OAT; VALERIAN ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SULFUR 3; 3; 7; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2092_5758d564-28cd-cdbd-e053-2991aa0a8a42 48951-2092 HUMAN OTC DRUG Bryophyllum Conchae Bryophyllum Conchae PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; OSTREA EDULIS SHELL 5; 7 [hp_X]/1; [hp_X]/1 N 20181231 48951-2094_040b6c18-1a0e-4c08-b9fb-dcd26b753f8a 48951-2094 HUMAN OTC DRUG Bryophyllum e fol. 10 Bryophyllum e fol. 10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF 1 [hp_X]/mL N 20181231 48951-2095_97869a54-17e3-4c93-af55-be9d28be5d83 48951-2095 HUMAN OTC DRUG Bryophyllum e fol. 10 Bryophyllum e fol. 10 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF 1 [hp_X]/1 N 20181231 48951-2096_338f2bf7-6f1f-47dd-8435-a99cb83206ab 48951-2096 HUMAN OTC DRUG Bryophyllum e fol. 3 Special Order Bryophyllum e fol. 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF 3 [hp_X]/mL N 20181231 48951-2099_559de47e-754e-0f65-e054-00144ff88e88 48951-2099 HUMAN OTC DRUG Bryophyllum e fol. 5% Bryophyllum e fol. 5% LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF 1 [hp_X]/mL N 20181231 48951-2102_559f1dfb-0a8f-3827-e054-00144ff88e88 48951-2102 HUMAN OTC DRUG Citrus Cydonia 1 Citrus Cydonia 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE 1; 1 [hp_X]/mL; [hp_X]/mL N 20181231 48951-2104_57468825-f779-5b08-e053-2991aa0a10fd 48951-2104 HUMAN OTC DRUG Barium Conchae Mercurius Special Order Barium Conchae Mercurius Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BARIUM IODATE; BERBERIS VULGARIS ROOT BARK; MERCURIC SULFIDE; FERROUS ARSENATE; BARIUM CITRATE; OSTREA EDULIS SHELL; MERCURY 4; 4; 6; 6; 8; 10; 14 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2105_559d986c-0851-6f77-e054-00144ff8d46c 48951-2105 HUMAN OTC DRUG Bryophyllum Conchae Special Order Bryophyllum Conchae Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; OSTREA EDULIS SHELL 5; 7 [hp_X]/mL; [hp_X]/mL N 20181231 48951-2106_c121d46a-a455-4ed7-8116-3153e20ed108 48951-2106 HUMAN OTC DRUG Belladonna ex herba 3 Special Order Belladonna ex herba 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA 3 [hp_X]/mL N 20181231 48951-2108_a0e22454-5ba9-47f1-8003-8ffd8e9ae0ef 48951-2108 HUMAN OTC DRUG Bambusa Viscum Stannum Special Order Bambusa Viscum Stannum Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; BOS TAURUS INTERVERTEBRAL DISC; ROSMARINUS OFFICINALIS FLOWERING TOP; VISCUM ALBUM FRUITING TOP; TIN; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP 5; 6; 6; 6; 6; 6; 7; 12; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-2109_e3cc2d2f-2324-4932-84c6-267c22215e30 48951-2109 HUMAN OTC DRUG Bambusa Nicotiana Special Order Bambusa Nicotiana Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BAMBUSA VULGARIS WHOLE; STACHYS OFFICINALIS; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; BOS TAURUS INTERVERTEBRAL DISC; BOS TAURUS PITUITARY GLAND; TOBACCO LEAF; TIN; COLLOIDAL SILICON DIOXIDE; EQUISETUM ARVENSE TOP 6; 6; 6; 7; 8; 8; 10; 10; 12; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-2110_27a09a7c-eac3-4787-97f5-183d4d50d5df 48951-2110 HUMAN OTC DRUG Bryonia Stannum Special Order Bryonia Stannum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; TIN 3; 17 [hp_X]/mL; [hp_X]/mL N 20181231 48951-2111_7416822b-62ea-4d8c-a1d2-2db65470812b 48951-2111 HUMAN OTC DRUG Berberis Oxalis Special Order Berberis Oxalis Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; OXALIS MONTANA LEAF; SAW PALMETTO; URTICA URENS; VISCUM ALBUM FRUITING TOP; MAGNESIUM SULFATE; BOS TAURUS PROSTATE GLAND; PENOXSULAM 2; 3; 3; 3; 4; 6; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-2112_57fc871f-c329-da7b-e053-2991aa0a3280 48951-2112 HUMAN OTC DRUG Betula e cort. 2 Special Order Betula e cort. 2 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS BARK 2 [hp_X]/mL N 20181231 48951-2113_5759411c-dac8-7220-e053-2991aa0a2ce7 48951-2113 HUMAN OTC DRUG Bryophyllum Quartz Bryophyllum Quartz PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; SILVER; OSTREA EDULIS SHELL; SILICON DIOXIDE 4; 6; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2114_5796930a-4789-2fab-e053-2a91aa0ad549 48951-2114 HUMAN OTC DRUG Betula Rhus Special Order Betula Rhus Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS BARK; SAGE; FILIPENDULA ULMARIA ROOT; URTICA URENS; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; COLCHICUM AUTUMNALE WHOLE; FORMICA RUFA; TOXICODENDRON PUBESCENS LEAF 2; 2; 2; 2; 3; 4; 5; 10; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-2115_5447b876-d620-0a26-e054-00144ff8d46c 48951-2115 HUMAN OTC DRUG Berberis Prunus Berberis Prunus OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE; BERBERIS VULGARIS ROOT BARK; LEMON; QUINCE 1; 1; 2; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-2116_54ad5227-63ca-3326-e054-00144ff8d46c 48951-2116 HUMAN OTC DRUG Bismuth Stibium Bismuth Stibium OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GARLIC; CHELIDONIUM MAJUS; TURMERIC; THUJA OCCIDENTALIS WHOLE; BISMUTH; ANTIMONY 1; 1; 1; 1; 2; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-2117_543a1390-918e-47dd-e054-00144ff8d46c 48951-2117 HUMAN OTC DRUG Berberis Oxalis Berberis Oxalis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; OXALIS STRICTA WHOLE; SAW PALMETTO; URTICA URENS; VISCUM ALBUM FRUITING TOP; MAGNESIUM SULFATE, UNSPECIFIED; BOS TAURUS PROSTATE GLAND; PENOXSULAM 1; 3; 3; 3; 4; 6; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-2119_54c4f177-a77d-5dfa-e054-00144ff88e88 48951-2119 HUMAN OTC DRUG Berberis Larix Berberis Larix PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ACHILLEA MILLEFOLIUM; BERBERIS VULGARIS ROOT BARK; EQUISETUM ARVENSE TOP; LYTTA VESICATORIA; APIS MELLIFERA; LARIX DECIDUA RESIN 3; 3; 3; 6; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3001_5759461e-4c30-34ea-e053-2991aa0abffa 48951-3001 HUMAN OTC DRUG Cactus Cinis Avenae Cactus Cinis Avenae PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SELENICEREUS GRANDIFLORUS STEM; HAWTHORN LEAF WITH FLOWER; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; ARNICA MONTANA 3; 3; 6; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3002_559e14c5-686f-15ba-e054-00144ff88e88 48951-3002 HUMAN OTC DRUG Cactus Cinis Avenae Special Order Cactus Cinis Avenae Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SELENICEREUS GRANDIFLORUS STEM; HAWTHORN LEAF WITH FLOWER; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; ARNICA MONTANA 3; 3; 6; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3003_1441ab96-24e4-41f3-9555-41b2d77bde5f 48951-3003 HUMAN OTC DRUG Cactus Crataegus Special Order Cactus Crataegus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SELENICEREUS GRANDIFLORUS STEM; HAWTHORN LEAF WITH FLOWER; MELISSA OFFICINALIS 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3004_5796930a-477b-2fab-e053-2a91aa0ad549 48951-3004 HUMAN OTC DRUG Cactus Crataegus Cactus Crataegus CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; SELENICEREUS GRANDIFLORUS STEM; NITROGLYCERIN; ARNICA MONTANA; GOLD; TOBACCO LEAF; ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; STRYCHNOS NUX-VOMICA SEED; LATRODECTUS MACTANS 2; 3; 5; 9; 9; 11; 13; 13; 13; 16 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3005_5758fc0c-68bf-9392-e053-2a91aa0a4775 48951-3005 HUMAN OTC DRUG Cactus Crataegus Cactus Crataegus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SELENICEREUS GRANDIFLORUS STEM; HAWTHORN LEAF WITH FLOWER; MELISSA OFFICINALIS 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3006_30d9eca8-5861-422d-a702-5a83f3b003bb 48951-3006 HUMAN OTC DRUG Calcium carb. Cortex Quercus 30 Special Order Calcium carb. Cortex Quercus 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CARBONATE ION; QUERCUS ROBUR WHOLE 30; 30 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3007_b93104b0-a851-4877-aa16-3ad7175d76bc 48951-3007 HUMAN OTC DRUG Calcium carbonicum 3 Special Order Calcium carbonicum 3 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CARBONATE ION 3 [hp_X]/g N 20181231 48951-3008_67d058c9-bbc1-4249-b115-3d5b0688898c 48951-3008 HUMAN OTC DRUG Calcium Carbonicum 30 Special Order Calcium Carbonicum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CARBONATE ION 30 [hp_X]/mL N 20181231 48951-3009_b1f93276-a3e9-4781-87ba-27431f694517 48951-3009 HUMAN OTC DRUG Calendula 10 Calendula 10 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g N 20181231 48951-3010_64d67f68-0b2c-4ef4-b4d9-900bb8e5e8b4 48951-3010 HUMAN OTC DRUG Calendula Healing Calendula Healing GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g N 20181231 48951-3011_bd19aba7-71ce-4481-a533-136f24979f6e 48951-3011 HUMAN OTC DRUG Calendula ex herba 3 Special Order Calendula ex herba 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]/mL N 20181231 48951-3013_57fc871f-c30f-da7b-e053-2991aa0a3280 48951-3013 HUMAN OTC DRUG Calendula ex herba 6 Special Order Calendula ex herba 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_X]/mL N 20181231 48951-3015_57970b4e-b681-2c59-e053-2991aa0a683f 48951-3015 HUMAN OTC DRUG Calendula Stibium Calendula Stibium CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP; ANTIMONY 2; 3 [hp_X]/g; [hp_X]/g N 20181231 48951-3018_5900725d-7539-4b9f-9d8c-02d9bd710be5 48951-3018 HUMAN OTC DRUG Capsicum Chamomilla Special Order Capsicum Chamomilla Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEVISTICUM OFFICINALE ROOT; MATRICARIA RECUTITA; PAPRIKA; PULSATILLA VULGARIS; MERCURIC IODIDE; FERROSOFERRIC PHOSPHATE 2; 3; 6; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3019_5759411c-daa7-7220-e053-2991aa0a2ce7 48951-3019 HUMAN OTC DRUG Capsicum Chamomilla Capsicum Chamomilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEVISTICUM OFFICINALE ROOT; MATRICARIA RECUTITA; PAPRIKA; PULSATILLA VULGARIS; MERCURIC IODIDE; FERROSOFERRIC PHOSPHATE 2; 3; 6; 6; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3020_200bff68-bc6c-433a-a045-40345548b714 48951-3020 HUMAN OTC DRUG Carbo Betulae 20 Special Order Carbo Betulae 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL 20 [hp_X]/mL N 20181231 48951-3021_9d33bd5a-d109-473c-b74d-130bed591670 48951-3021 HUMAN OTC DRUG Carbo Betulae 30 Special Order Carbo Betulae 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL 30 [hp_X]/mL N 20181231 48951-3025_eb3f1e0d-1815-4104-8882-4aa677a277fb 48951-3025 HUMAN OTC DRUG Carbo Sulfur Carbo Sulfur POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL; SULFUR 2; 2 [hp_X]/g; [hp_X]/g N 20181231 48951-3027_a3a714f1-9cef-4759-99a2-72a89506d96c 48951-3027 HUMAN OTC DRUG Carduus Marianus e fruct. 30 Carduus Marianus e fruct. 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE 1 [hp_X]/mL N 20181231 48951-3028_c33b6579-06f4-4104-8c0a-b742fea98430 48951-3028 HUMAN OTC DRUG Carduus marianus e fruct. 6 Special Order Carduus marianus e fruct. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE 6 [hp_X]/mL N 20181231 48951-3029_edafb4be-45d2-4bf2-a073-a3eef3f71d97 48951-3029 HUMAN OTC DRUG Carduus Oxalis Special Order Carduus Oxalis Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE; OXALIS MONTANA LEAF 2; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3030_56e3e183-7c8a-33b2-e054-00144ff88e88 48951-3030 HUMAN OTC DRUG Carduus Oxalis Carduus Oxalis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE; OXALIS ACETOSELLA LEAF 1; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3031_5759c0ba-fb99-0a99-e053-2a91aa0a5fdc 48951-3031 HUMAN OTC DRUG Carduus Oxalis Special Order Carduus Oxalis Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE; OXALIS ACETOSELLA LEAF 3; 3 [hp_X]/1; [hp_X]/1 N 20181231 48951-3032_559e704e-1b3f-226f-e054-00144ff8d46c 48951-3032 HUMAN OTC DRUG Carduus Viscum Carduus Viscum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE; VISCUM ALBUM FRUITING TOP; MAMMAL LIVER 3; 4; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3033_c3f696b6-3082-4806-9f03-f29d1d56f24b 48951-3033 HUMAN OTC DRUG Carduus Viscum Special Order Carduus Viscum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE; VISCUM ALBUM FRUITING TOP; MAMMAL LIVER 3; 4; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3034_56e3d4c6-3df3-2675-e054-00144ff88e88 48951-3034 HUMAN OTC DRUG Carpellum Mali Comp. Carpellum Mali Comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ENGLISH WALNUT; MALUS DOMESTICA WHOLE 4; 4 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3035_aa93c9b5-f25e-4ef6-8e33-9d0cb3b6350c 48951-3035 HUMAN OTC DRUG Cartilago Argentum Cartilago Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MANDRAGORA OFFICINARUM ROOT; ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARNICA MONTANA; BETULA PUBESCENS LEAF; BOS TAURUS CARTILAGE; SILVER 5; 6; 6; 6; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3036_1f8da0d9-b5e0-493e-b212-580df96199df 48951-3036 HUMAN OTC DRUG Cartilago Argentum Joint Support Cartilago Argentum Joint Support CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; MANDRAGORA OFFICINARUM ROOT; ANTIMONY TRISULFIDE; ACONITUM NAPELLUS; ARNICA MONTANA; BOS TAURUS CARTILAGE; SILVER 3; 3; 5; 6; 6; 6; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3037_36181840-f632-11de-8a39-0800200c9a66 48951-3037 HUMAN OTC DRUG Cartilago Argentum Joint Support MANDRAGORA OFFICINARUM ROOT BETULA PENDULA LEAF ACONITUM NAPELLUS ROOT ARNICA MONTANA SILVER PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc MANDRAGORA OFFICINARUM ROOT; BETULA PENDULA LEAF; ACONITUM NAPELLUS ROOT; ARNICA MONTANA; SILVER 5; 5; 6; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3039_549d9cc4-13e3-57ad-e054-00144ff8d46c 48951-3039 HUMAN OTC DRUG Cartilago Betula Cartilago Betula LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; ACONITUM NAPELLUS; ARNICA MONTANA; BOS TAURUS CARTILAGE; TIN; GOLD; ONION; FORMICA RUFA 5; 6; 6; 8; 8; 10; 17; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3040_57970b4e-b66f-2c59-e053-2991aa0a683f 48951-3040 HUMAN OTC DRUG Cartilago Betula Cartilago Betula CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; BETULA PUBESCENS LEAF; ACONITUM NAPELLUS; ARNICA MONTANA; BOS TAURUS CARTILAGE; FORMICA RUFA; TIN; GOLD 3; 3; 6; 6; 6; 7; 8; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3041_5759c0ba-fba7-0a99-e053-2a91aa0a5fdc 48951-3041 HUMAN OTC DRUG Cartilago Betula Cartilago Betula PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; ACONITUM NAPELLUS; ARNICA MONTANA; BOS TAURUS CARTILAGE; TIN; GOLD; ONION; FORMICA RUFA 5; 6; 6; 8; 8; 10; 17; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3042_f025b01d-327f-4fe8-98a2-d1b33a937cf9 48951-3042 HUMAN OTC DRUG Cartilago Quartz Cartilago Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA; BEEF; COLLOIDAL SILICON DIOXIDE 3; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3043_57970b4e-b65d-2c59-e053-2991aa0a683f 48951-3043 HUMAN OTC DRUG Cartilago Quartz Cartilago Quartz CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; BEEF; SILICON DIOXIDE 2; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3044_5759ec4a-50e6-0a97-e053-2a91aa0a6b24 48951-3044 HUMAN OTC DRUG Cartilago Quartz Cartilago Quartz PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA; BEEF; SILICON DIOXIDE 2; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3045_a40bcf4e-fa9c-4107-a7d5-73807de0208d 48951-3045 HUMAN OTC DRUG Cavum Tympani 8 Special Order Cavum Tympani 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 8 [hp_X]/mL N 20181231 48951-3046_57fae1e5-e184-5dfa-e053-2991aa0aed89 48951-3046 HUMAN OTC DRUG Celandine Honey Celandine Honey LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; HONEY 4; 4 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3047_6dfd5061-4710-43bb-bab8-7f06f078bc97 48951-3047 HUMAN OTC DRUG Cerebellum 4 Special Order Cerebellum 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS CEREBELLUM 4 [hp_X]/mL N 20181231 48951-3048_ef7a027e-f277-4a9e-8439-de516aa59186 48951-3048 HUMAN OTC DRUG Cerebellum Thalamus A Cerebellum Thalamus A LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS CEREBELLUM; COLLOIDAL SILICON DIOXIDE; BOS TAURUS BRAIN; SUS SCROFA THALAMUS; BOS TAURUS PITUITARY GLAND; BOS TAURUS EYE; BOS TAURUS NERVE 8; 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3049_5759b796-8d64-7784-e053-2991aa0a1885 48951-3049 HUMAN OTC DRUG Cerebellum Thalamus A Cerebellum Thalamus A PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS CEREBELLUM; SILICON DIOXIDE; BOS TAURUS BRAIN; BOS TAURUS PITUITARY GLAND; BOS TAURUS EYE; SUS SCROFA THALAMUS 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3050_559e8eab-f641-2551-e054-00144ff8d46c 48951-3050 HUMAN OTC DRUG Cerebellum Thalamus A Aurm Cerebellum Thalamus A Aurum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MYRRH; FRANKINCENSE; BOS TAURUS CEREBELLUM; SILICON DIOXIDE; BOS TAURUS BRAIN; BOS TAURUS PITUITARY GLAND; BOS TAURUS EYE; BOS TAURUS NERVE; SUS SCROFA THALAMUS; GOLD 7; 7; 8; 8; 8; 8; 8; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3051_57596ce3-8b2a-29d1-e053-2a91aa0afc5b 48951-3051 HUMAN OTC DRUG Cerebellum Thalamus A Aurum Cerebellum Thalamus A Aurum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MYRRH; FRANKINCENSE; BOS TAURUS CEREBELLUM; SILICON DIOXIDE; BOS TAURUS BRAIN; BOS TAURUS PITUITARY GLAND; BOS TAURUS EYE; SUS SCROFA THALAMUS; GOLD 7; 7; 8; 8; 8; 8; 8; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3052_54ae69d9-8260-6212-e054-00144ff8d46c 48951-3052 HUMAN OTC DRUG Cerebellum Thalamus B Cerebellum Thalamus B LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS CEREBELLUM; BOS TAURUS BRAIN; BOS TAURUS PINEAL GLAND; BOS TAURUS NERVE; BIFENTHRIN; SUS SCROFA THALAMUS; SUS SCROFA EAR 8; 8; 8; 8; 8; 8; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3053_5759461e-4c48-34ea-e053-2991aa0abffa 48951-3053 HUMAN OTC DRUG Cerebellum Thalamus B Cerebellum Thalamus B PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP; BOS TAURUS BRAIN; BOS TAURUS BONE; BOS TAURUS NERVE; BIFENTHRIN; SUS SCROFA THALAMUS; SUS SCROFA EAR 8; 8; 8; 8; 8; 8; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3054_559eb306-8d2b-29e8-e054-00144ff88e88 48951-3054 HUMAN OTC DRUG Cerebellum Thalamus B Aurum Cerebellum Thalamus B Aurum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MYRRH; FRANKINCENSE; BOS TAURUS CEREBELLUM; BOS TAURUS BRAIN; BOS TAURUS PINEAL GLAND; BOS TAURUS NERVE; BIFENTHRIN; SUS SCROFA THALAMUS; GOLD; SUS SCROFA EAR 7; 7; 8; 8; 8; 8; 8; 8; 10; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3055_5759be23-c4c8-5078-e053-2a91aa0a7d8e 48951-3055 HUMAN OTC DRUG Cerebellum Thalamus B Aurum Cerebellum Thalamus B Aurum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MYRRH; FRANKINCENSE; BOS TAURUS CEREBELLUM; BOS TAURUS BRAIN; BOS TAURUS PINEAL GLAND; BOS TAURUS NERVE; BIFENTHRIN; SUS SCROFA THALAMUS; GOLD; SUS SCROFA EAR 7; 7; 8; 8; 8; 8; 8; 8; 10; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3056_57fc871f-c301-da7b-e053-2991aa0a3280 48951-3056 HUMAN OTC DRUG Cerussite 8 Cerussite 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD CARBONATE 8 [hp_X]/mL N 20181231 48951-3059_c4ea84b8-85a9-48ed-9bae-736486465b20 48951-3059 HUMAN OTC DRUG Chamomilla 10 Special Order Chamomilla 10 Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 1 [hp_X]/g N 20181231 48951-3060_c6d5c928-d954-4dfb-849b-fdf5e5ca27a9 48951-3060 HUMAN OTC DRUG Chamomilla Belladonna Adult Size Chamomilla Belladonna Adult Size SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; ATROPA BELLADONNA; SILVER 3; 3; 4; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3061_50a80ab6-08a7-4332-bbda-828feeef600d 48951-3061 HUMAN OTC DRUG Chamomilla Belladonna Special Order Chamomilla Belladonna Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA; ATROPA BELLADONNA; TOBACCO LEAF 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3062_e8313580-decb-11de-8a39-0800200c9a66 48951-3062 HUMAN OTC DRUG Chamomila Cramp Relief MATRICARIA RECUTITA ATROPA BELLADONNA ROOT TOBACCO LEAF PELLET ORAL 20091201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc MATRICARIA RECUTITA; ATROPA BELLADONNA ROOT; TOBACCO LEAF 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3064_8deb41c0-6477-49d7-82a1-037d0aa68758 48951-3064 HUMAN OTC DRUG Chamomilla Cupro 3 Special Order Chamomilla Cupro 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA; COPPER 3; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3065_7d891593-9b28-4dba-be1d-497a94302a6f 48951-3065 HUMAN OTC DRUG Chamomilla e pl. tota 15 Special Order Chamomilla e pl. tota 15 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 15 [hp_X]/mL N 20181231 48951-3066_3ad79ad7-9eed-4e34-aa79-c994bd20ae7c 48951-3066 HUMAN OTC DRUG Chamomilla e pl. tota 3 Special Order Chamomilla e pl. tota 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 3 [hp_X]/mL N 20181231 48951-3067_527716a4-2826-4de0-8e22-b8c082cdfd41 48951-3067 HUMAN OTC DRUG Chamomilla e pl. tota 30 Special Order Chamomilla e pl. tota 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 30 [hp_X]/mL N 20181231 48951-3068_575a8094-128b-e160-e053-2a91aa0aba53 48951-3068 HUMAN OTC DRUG Chamomilla e pl. tota 30 Special Order Chamomilla e pl. tota 30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 30 [hp_X]/1 N 20181231 48951-3070_397c735e-c980-4c4c-bebf-8e2f9ead6f57 48951-3070 HUMAN OTC DRUG Chamomilla e rad. 20 Special Order Chamomilla e rad. 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 20 [hp_X]/mL N 20181231 48951-3072_e40ef8f8-0322-40a2-ba3e-a02fbb311ff7 48951-3072 HUMAN OTC DRUG Chamomilla e rad. 6 Special Order Chamomilla e rad. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 6 [hp_X]/mL N 20181231 48951-3073_57e79e9c-ca0e-a22f-e053-2a91aa0ae60e 48951-3073 HUMAN OTC DRUG Chelidonium Cichorium Chelidonium Cichorium CAPSULE, LIQUID FILLED ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; CHICORY ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; BOS TAURUS GALLBLADDER; IRON 4; 4; 4; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3075_86df6318-1df9-4b5e-90f4-2a485d47dc65 48951-3075 HUMAN OTC DRUG Chelidonium Colocynthis Special Order Chelidonium Colocynthis Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT 2; 3 [hp_X]/1; [hp_X]/1 N 20181231 48951-3076_56e289a1-3e2a-0c1b-e054-00144ff88e88 48951-3076 HUMAN OTC DRUG Chelidonium Curcuma Chelidonium Curcuma LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT; TURMERIC 1; 1 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3077_575a7974-245f-1709-e053-2991aa0a6fa0 48951-3077 HUMAN OTC DRUG Chelidonium Curcuma Chelidonium Curcuma PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT; TURMERIC 3; 3 [hp_X]/1; [hp_X]/1 N 20181231 48951-3078_56e23999-2749-682a-e054-00144ff8d46c 48951-3078 HUMAN OTC DRUG Chelidonium Curcuma Thuja Chelidonium Curcuma Thuja LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT; TURMERIC; THUJA OCCIDENTALIS WHOLE 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3079_da54198e-f5c3-4c24-a9e4-02985b370516 48951-3079 HUMAN OTC DRUG Chelidonium Ferro 3 Chelidonium Ferro 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT 3 [hp_X]/mL N 20181231 48951-3080_57fae1e5-e175-5dfa-e053-2991aa0aed89 48951-3080 HUMAN OTC DRUG Chelidonium Rosa Chelidonium Rosa LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERRIC OXIDE RED; SEDUM ROSEUM WHOLE; CHELIDONIUM MAJUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; LARIX DECIDUA RESIN 3; 3; 4; 4; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3081_65970c54-952f-402c-b9cd-02fc85ece0da 48951-3081 HUMAN OTC DRUG Chelidonium Spongia Special Order Chelidonium Spongia Special Order OINTMENT ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE WHOLE; SPONGIA OFFICINALIS WHOLE 2; 2; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3082_57d355ed-c55a-0827-e053-2991aa0a9651 48951-3082 HUMAN OTC DRUG Chestnut Beeswax Chestnut Beeswax OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; EQUISETUM ARVENSE TOP; BRYONIA ALBA ROOT; FORMICA RUFA 1; 2; 3; 5 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3083_0532f490-2150-11df-8a39-0800200c9a66 48951-3083 HUMAN OTC DRUG Chicory Ginger Digestive Bitters SILYBUM MARIANUM SEED GENTIANA LUTEA ROOT ARTEMISIA VULGARIS ROOT GINGER CHELIDONIUM MAJUS BLACK PEPPER LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc SILYBUM MARIANUM SEED; GENTIANA LUTEA ROOT; ARTEMISIA VULGARIS ROOT; GINGER; CHELIDONIUM MAJUS; BLACK PEPPER 1; 1; 1; 1; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3085_aa4fdae4-e107-4cf6-815d-2b54245224a4 48951-3085 HUMAN OTC DRUG Chrysolith 6 Chrysolith 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 6 [hp_X]/mL N 20181231 48951-3086_544c80da-8f1d-1e87-e054-00144ff8d46c 48951-3086 HUMAN OTC DRUG Chrysolith Retina Chrysolith Retina LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILICON DIOXIDE; LARIX DECIDUA RESIN; BOS TAURUS EYE 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3087_575a4f17-ab14-87ca-e053-2a91aa0a279d 48951-3087 HUMAN OTC DRUG Chrysolith Retina Chrysolith Retina PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILICON DIOXIDE; LARIX DECIDUA RESIN; BOS TAURUS EYE 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3088_55a00928-433d-5525-e054-00144ff88e88 48951-3088 HUMAN OTC DRUG Chrysosplenium Chamomilla Chrysosplenium Chamomilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA; CHRYSOSPLENETIN; CICHORIUM INTYBUS WHOLE; TARAXACUM PALUSTRE ROOT 3; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3089_575a4f17-ab22-87ca-e053-2a91aa0a279d 48951-3089 HUMAN OTC DRUG Chrysosplenium Chamomilla Chrysosplenium Chamomilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA; CHRYSOSPLENETIN; CICHORIUM INTYBUS WHOLE; TARAXACUM PALUSTRE ROOT 3; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3091_c6f7768d-4e70-478b-a873-78f7301df50e 48951-3091 HUMAN OTC DRUG Cichorium Oxalis Cichorium Oxalis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CICHORIUM INTYBUS WHOLE; OXALIS MONTANA LEAF; ACTIVATED CHARCOAL; SUS SCROFA PANCREAS; BARIUM CITRATE; IRON 3; 3; 6; 6; 10; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3092_575a4f17-ab06-87ca-e053-2a91aa0a279d 48951-3092 HUMAN OTC DRUG Cichorium Oxalis Special Order Cichorium Oxalis Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CICHORIUM INTYBUS WHOLE; OXALIS ACETOSELLA LEAF; ACTIVATED CHARCOAL; SUS SCROFA PANCREAS; BARIUM CITRATE; IRON 3; 3; 6; 6; 10; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3093_55a03e62-0816-6e95-e054-00144ff8d46c 48951-3093 HUMAN OTC DRUG Cichorium Stibium Special Order Cichorium Stibium Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CICHORIUM INTYBUS WHOLE; TOBACCO LEAF; SUS SCROFA PANCREAS; ANTIMONY 4; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3094_575a4f17-aaf9-87ca-e053-2a91aa0a279d 48951-3094 HUMAN OTC DRUG Cichorium Stibium Cichorium Stibium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CICHORIUM INTYBUS WHOLE; TOBACCO LEAF; SUS SCROFA PANCREAS; ANTIMONY 4; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3095_7a80ceb2-da04-42a6-8cee-cb095416a044 48951-3095 HUMAN OTC DRUG Chamomilla Belladonna Child Size Special Order Chamomilla Belladonna Child Size Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHAMOMILE; ECHINACEA ANGUSTIFOLIA; ATROPA BELLADONNA; SILVER 3; 3; 4; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3096_6f3d0b8c-e6b6-4b9b-b3e6-c32cfa0a59ab 48951-3096 HUMAN OTC DRUG Caraway Oil 1 Special Order Caraway Oil 1 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CARAWAY OIL 2 [hp_X]/g N 20181231 48951-3097_4f7961ad-2492-4c61-8614-70c17dc7dff1 48951-3097 HUMAN OTC DRUG Cinis Quercus 3 Special Order Cinis Quercus 3 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE 3 [hp_X]/g N 20181231 48951-3100_575a4d9a-4dbd-9b6e-e053-2a91aa0a5e1f 48951-3100 HUMAN OTC DRUG Cinnabar comp. Cinnabar comp. PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA VENOM; ATROPA BELLADONNA; MERCURIC SULFIDE 6; 6; 7 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3101_5447e6cb-3bc4-23fb-e054-00144ff8d46c 48951-3101 HUMAN OTC DRUG Cinnabar Dandelion Cinnabar Dandelion LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ELYMUS REPENS ROOT; TARAXACUM PALUSTRE ROOT; FERROUS DISULFIDE; CARBONATE ION; MERCURIC CATION 3; 3; 8; 10; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3102_a8f9adb0-f62d-11de-8a39-0800200c9a66 48951-3102 HUMAN OTC DRUG Cinnabar Dandelion Cold Relief TARAXACUM OFFICINALE ELYMUS REPENS ROOT POTASH MERCURIC SULFIDE PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc TARAXACUM OFFICINALE; ELYMUS REPENS ROOT; POTASH; MERCURIC SULFIDE 2; 3; 10; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3103_54af55c0-bb37-2728-e054-00144ff88e88 48951-3103 HUMAN OTC DRUG Citrus Cydonia 3 Citrus Cydonia 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE 1; 1 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3104_54af34bc-c864-7236-e054-00144ff88e88 48951-3104 HUMAN OTC DRUG Citrus Cydonia 5% CITRUS CYDONIA 5% LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE 1; 1 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3105_57fab597-5040-8437-e053-2a91aa0af98a 48951-3105 HUMAN OTC DRUG Citrus Cydonia 1 Citrus Cydonia 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE 1; 1 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3106_559f5ad0-5ec3-401d-e054-00144ff88e88 48951-3106 HUMAN OTC DRUG Citrus Cydonia 7 Citrus Cydonia 7 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE 1; 1 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3107_559fa71f-f99e-55e8-e054-00144ff8d46c 48951-3107 HUMAN OTC DRUG Citrus Quartz Citrus Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE; AGROPYRON FRAGILE WHOLE; SAMBUCUS CANADENSIS FLOWER; TILIA AMERICANA FLOWER; LARIX DECIDUA RESIN; SILICON DIOXIDE 2; 2; 5; 5; 5; 10; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3108_9899d8f0-b3e0-4565-8fca-5f872f307382 48951-3108 HUMAN OTC DRUG Cocculus Conium Special Order Cocculus Conium Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANAMIRTA COCCULUS WHOLE; CONIUM MACULATUM ROOT; AMBERGRIS; LIQUID PETROLEUM 4; 4; 7; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3109_575b07bb-d13b-d09d-e053-2991aa0ab5ec 48951-3109 HUMAN OTC DRUG Cocculus Conium Cocculus Conium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANAMIRTA COCCULUS WHOLE; CONIUM MACULATUM ROOT; AMBERGRIS; LIQUID PETROLEUM 4; 4; 7; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3110_a0a6a0e5-0c1e-42f6-91ff-408040b62609 48951-3110 HUMAN OTC DRUG Cochlea 8 Special Order Cochlea 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE 8 [hp_X]/mL N 20181231 48951-3112_559fa71f-f9cb-55e8-e054-00144ff8d46c 48951-3112 HUMAN OTC DRUG Colchicum Chelidonium Colchicum Chelidonium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE WHOLE 3; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3113_575b17be-b649-a77e-e053-2991aa0a0bab 48951-3113 HUMAN OTC DRUG Colchicum Chelidonium Special Order Colchicum Chelidonium Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE WHOLE 3; 3 [hp_X]/1; [hp_X]/1 N 20181231 48951-3114_559f984c-9023-3a48-e054-00144ff8d46c 48951-3114 HUMAN OTC DRUG Colon 6 Colon 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS COLON 6 [hp_X]/mL N 20181231 48951-3115_559f984c-902f-3a48-e054-00144ff8d46c 48951-3115 HUMAN OTC DRUG Colon 8 Special Order Colon 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS COLON 8 [hp_X]/mL N 20181231 48951-3116_5794ea28-d6c8-4344-e053-2991aa0a66fc 48951-3116 HUMAN OTC DRUG Conchae 5 comp. Conchae 5 comp. POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OSTREA EDULIS SHELL; QUERCUS ROBUR WHOLE 1; 4 [hp_X]/g; [hp_X]/g N 20181231 48951-3117_559fc931-b816-4e65-e054-00144ff88e88 48951-3117 HUMAN OTC DRUG Conchae Argentum Conchae Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; ASPLENIUM SCOLOPENDRIUM WHOLE; SILVER; OSTREA EDULIS SHELL; AMANITA MUSCARIA FRUITING BODY 3; 3; 3; 6; 6; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3118_575acf1f-d553-39aa-e053-2a91aa0a3633 48951-3118 HUMAN OTC DRUG Conchae Argentum Conchae Argentum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; ASPLENIUM SCOLOPENDRIUM TOP; SILVER; OSTREA EDULIS SHELL; AMANITA MUSCARIA FRUITING BODY 3; 3; 3; 6; 6; 7 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3119_f7882132-e05b-4f28-8b2a-79ad1b436f04 48951-3119 HUMAN OTC DRUG Conchae Urtica Special Order Conchae Urtica Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. URTICA DIOICA ROOT; SLOE; EQUISETUM ARVENSE TOP; FORMICA RUFA; LEVISTICUM OFFICINALE ROOT; MAMMAL LIVER; PORK KIDNEY; SILVER; OSTREA EDULIS SHELL; THUJA OCCIDENTALIS WHOLE; AMANITA MUSCARIA FRUITING BODY; COLLOIDAL SILICON DIOXIDE; MERCURY 2; 2; 2; 2; 2; 4; 4; 5; 5; 6; 7; 12; 14 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3121_8e2db638-b4df-462c-94de-a6cc7b15d628 48951-3121 HUMAN OTC DRUG Conjunctiva Argentum Special Order Conjunctiva Argentum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; ATROPA BELLADONNA; COLLOIDAL SILICON DIOXIDE; SILVER; BOS TAURUS EYE 3; 20; 20; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3122_575aaf87-8d35-5b43-e053-2991aa0ab7cd 48951-3122 HUMAN OTC DRUG Conjunctiva Argentum Conjunctiva Argentum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; ATROPA BELLADONNA; SILICON DIOXIDE; SILVER; BOS TAURUS EYE 3; 20; 20; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3124_57d39a95-de86-83c0-e053-2991aa0a6a4c 48951-3124 HUMAN OTC DRUG Copper Oxide 0.4 Copper Oxide 0.4 OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC OXIDE 1 [hp_X]/g N 20181231 48951-3125_e75ea0cf-a30a-49f6-a78e-16c59bce5f95 48951-3125 HUMAN OTC DRUG Cor 5 Special Order Cor 5 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART 5 [hp_X]/mL N 20181231 48951-3127_57fc1cf7-13fd-f841-e053-2991aa0a31c1 48951-3127 HUMAN OTC DRUG Cor Aurum 17/10 Cor Aurum 17/10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; GOLD; BEEF HEART 3; 3; 4; 10; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3128_90f0e853-5c08-457b-b887-cf75a48c4220 48951-3128 HUMAN OTC DRUG Cor Aurum 6/10 Special Order Cor Aurum 6/10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; BEEF HEART; GOLD 3; 3; 4; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3130_a7ce3f8e-9eb0-427c-a3c5-8a7f8d734950 48951-3130 HUMAN OTC DRUG Corallium rubrum Stibium 6 Corallium rubrum Stibium 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CORALLIUM RUBRUM EXOSKELETON; ANTIMONY 6; 6 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3131_56e46345-d524-3ce6-e054-00144ff88e88 48951-3131 HUMAN OTC DRUG Cordia Cordia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ARNICA MONTANA FLOWER; GOLD; SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; HAWTHORN LEAF WITH FLOWER; SAFFRON; DIGITALIS; EQUISETUM ARVENSE TOP; ST. JOHN'S WORT; LEONURUS CARDIACA FLOWERING TOP; MELISSA OFFICINALIS; SEDUM ROSEUM WHOLE; ROSMARINUS OFFICINALIS FLOWERING TOP; RUTA GRAVEOLENS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3132_f03010f1-f722-4c0a-bd1c-33033429a0d9 48951-3132 HUMAN OTC DRUG Corpus Succinum Special Order Corpus Succinum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS EYE; AMBER 6; 6 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3133_f11d33d3-0429-4d01-8f70-08eeebb74e54 48951-3133 HUMAN OTC DRUG Cortisonum 30 Special Order Cortisonum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CORTISONE 30 [hp_X]/mL N 20181231 48951-3134_e173e293-d2b4-4d4a-8953-a0881f249b3a 48951-3134 HUMAN OTC DRUG Crataegus Nicotiana Crataegus Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; CERIUM; BEEF HEART; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; TOBACCO LEAF 3; 6; 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3135_576ca7c0-cb39-2911-e053-2a91aa0af95e 48951-3135 HUMAN OTC DRUG Crataegus Nicotiana Crataegus Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; CERIUM; BEEF HEART; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; TOBACCO LEAF 1; 6; 6; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3136_56e46345-d514-3ce6-e054-00144ff88e88 48951-3136 HUMAN OTC DRUG Crataegus Onopordon Crataegus Onopordon LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; HAWTHORN LEAF WITH FLOWER; SELENICEREUS GRANDIFLORUS STEM; BEEF HEART; GOLD 2; 2; 3; 3; 4; 6; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3137_19d81d7b-4f7f-45c4-909e-3b836368749c 48951-3137 HUMAN OTC DRUG Cuprite 3 Special Order Cuprite 3 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC OXIDE 3 [hp_X]/g N 20181231 48951-3138_57970b4e-b64e-2c59-e053-2991aa0a683f 48951-3138 HUMAN OTC DRUG Cuprum 5 Cuprum 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER 5 [hp_X]/g N 20181231 48951-3139_72ddefdc-0833-4610-a0b6-d5d10873fd6c 48951-3139 HUMAN OTC DRUG Cuprum Aceticum 3 Cuprum Aceticum 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC ACETATE 3 [hp_X]/mL N 20181231 48951-3140_a272b9bc-f81b-42f1-b725-ddfe75b14a0b 48951-3140 HUMAN OTC DRUG Cuprum aceticum 4 Special Order Cuprum aceticum 4 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC ACETATE 4 [hp_X]/1 N 20181231 48951-3141_484ab8af-7d23-40e4-94f3-bb9213812fd8 48951-3141 HUMAN OTC DRUG Cuprum aceticum Nicotiana Cuprum aceticum Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC ACETATE; LOBELIA SPICATA LEAF; PORK KIDNEY; TOBACCO LEAF; ARSENIC TRIOXIDE 6; 6; 6; 10; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3142_576caff4-53ce-e3e9-e053-2991aa0a2450 48951-3142 HUMAN OTC DRUG Cuprum aceticum Nicotiana Cuprum aceticum Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC ACETATE; LOBELIA SPICATA LEAF; PORK KIDNEY; TOBACCO LEAF; ARSENIC TRIOXIDE 6; 6; 6; 10; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3143_56e4d9bf-7619-4f2b-e054-00144ff88e88 48951-3143 HUMAN OTC DRUG Cuprum aceticum Zincum valerianicum Cuprum aceticum Zincum valerianicum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC ACETATE; ZINC VALERATE DIHYDRATE 5; 5 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3144_4e912f9e-99c2-4668-aa09-8a58f9a563b2 48951-3144 HUMAN OTC DRUG Cuprum Nicotiana Cuprum Nicotiana OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC OXIDE; MATRICARIA RECUTITA; TOBACCO LEAF 1; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3145_56e4d9bf-7609-4f2b-e054-00144ff88e88 48951-3145 HUMAN OTC DRUG Cuprum Stannum Cuprum Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. NITRIC ACID; SULFURIC ACID; TIN; COPPER; POTASSIUM ALUM 2; 2; 2; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3146_56e4d9bf-75fa-4f2b-e054-00144ff88e88 48951-3146 HUMAN OTC DRUG Cuprum sulfuricum 6 Cuprum sulfuricum 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC SULFATE 6 [hp_X]/mL N 20181231 48951-3148_55a0a1e6-6eb1-69ab-e054-00144ff88e88 48951-3148 HUMAN OTC DRUG Cutis (feti) 8 Special Order Cutis (feti) 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA SKIN 8 [hp_X]/mL N 20181231 48951-3152_72a11b30-dc26-40ae-82eb-1a35a73d60c3 48951-3152 HUMAN OTC DRUG Cuprum Quartz (Red) Cuprum Quartz (Red) OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE; CUPRIC OXIDE 1; 1 [hp_X]/g; [hp_X]/g N 20181231 48951-3153_da314ac9-4b8c-41fc-a3cb-329de4089be7 48951-3153 HUMAN OTC DRUG Cuprum Quartz (Metallic) Cuprum Quartz (Metallic) OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER 1 [hp_X]/g N 20181231 48951-3154_a6b0a567-ed4f-43b7-866b-2041af1d6a66 48951-3154 HUMAN OTC DRUG Chelidonium Curcuma P Chelidonium Curcuma P LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT; TURMERIC 1; 1 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3156_575b07bb-d165-d09d-e053-2991aa0ab5ec 48951-3156 HUMAN OTC DRUG Citrus Urtica comp. Special Order Citrus Urtica comp. Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. WORMWOOD; URTICA URENS; LEMON; QUINCE; BERBERIS VULGARIS ROOT BARK; LARIX DECIDUA RESIN; SILICON DIOXIDE 1; 1; 2; 2; 3; 3; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3157_bce7af2b-9749-4d1b-b19a-ee798bb51ba1 48951-3157 HUMAN OTC DRUG Cor Aurum 6/10 Special Order Cor Aurum 6/10 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; BEEF HEART; GOLD 3; 3; 4; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3158_4ff65401-59f3-4e15-9470-c4bdc0be79e8 48951-3158 HUMAN OTC DRUG Crataegus Onopordon Special Order Crataegus Onopordon Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; HAWTHORN LEAF WITH FLOWER; SELENICEREUS GRANDIFLORUS STEM; BEEF HEART; GOLD 1; 1; 1; 3; 4; 6; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3159_544d265c-e104-42b9-e054-00144ff8d46c 48951-3159 HUMAN OTC DRUG Crataegus Ferrum Saccharum Special Order Crataegus Ferrum Saccharum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; SUCROSE; IRON 3; 3; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3160_5498cd1e-76d6-5223-e054-00144ff88e88 48951-3160 HUMAN OTC DRUG Crotalus terrificus 30 Special Order Crotalus terrificus 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CROTALUS DURISSUS TERRIFICUS VENOM 30 [hp_X]/mL N 20181231 48951-3161_575b17be-b657-a77e-e053-2991aa0a0bab 48951-3161 HUMAN OTC DRUG Collagen 6 Special Order Collagen 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOVINE TYPE I COLLAGEN 6 [hp_X]/1 N 20181231 48951-3162_e15a6cfd-535c-456a-80ed-3317f0584770 48951-3162 HUMAN OTC DRUG Cuprum Stannum Special Order Cuprum Stannum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. NITRIC ACID; SULFURIC ACID; TIN; COPPER; ALUMINUM HYDROXIDE 4; 4; 4; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3163_559fa71f-f9d9-55e8-e054-00144ff8d46c 48951-3163 HUMAN OTC DRUG Colchicum e tub. 4 Special Order Colchicum e tub. 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLCHICUM AUTUMNALE WHOLE 4 [hp_X]/mL N 20181231 48951-3164_09aaf520-4c47-4d21-9352-fa3def968cf9 48951-3164 HUMAN OTC DRUG Cor Aurum 17/10 Special Order Cor Aurum 17/10 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; GOLD; BEEF HEART 3; 3; 4; 10; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-3165_093127f0-1a9a-4064-ad62-578bdf933965 48951-3165 HUMAN PRESCRIPTION DRUG Crataegus e fol. et fructus 2 Special Order Crataegus e fol. et fructus 2 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER 2 [hp_X]/mL N 20181231 48951-3166_f028ccd0-7d24-4c65-a097-78342f9b23d5 48951-3166 HUMAN OTC DRUG Cuprum 17 Special Order Cuprum 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER 17 [hp_X]/mL N 20181231 48951-3167_559e14c5-68cc-15ba-e054-00144ff88e88 48951-3167 HUMAN OTC DRUG Calc. carb. Cortex Quercus Special Order Calc. carb. Cortex Quercus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CARBONATE ION; QUERCUS ROBUR WHOLE 30; 30 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3168_a533a190-b85c-405d-9013-71d8765273a5 48951-3168 HUMAN OTC DRUG Calendula Thuja Adult Size Calendula Thuja Adult Size SUPPOSITORY VAGINAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; SWEET MARJORAM; LILIUM LANCIFOLIUM WHOLE FLOWERING; THUJA OCCIDENTALIS WHOLE; WOOD CREOSOTE; PULSATILLA VULGARIS; SILVER; CANDIDA ALBICANS 2; 2; 2; 3; 3; 6; 6; 7; 33 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3169_5498d86c-63c8-524a-e054-00144ff88e88 48951-3169 HUMAN OTC DRUG Carbo Prunus comp. Special Order Carbo Prunus comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE; SULFUR; CUPRIC ACETATE; POTASSIUM PHOSPHATE, MONOBASIC; SILVER; ATROPA BELLADONNA; ACTIVATED CHARCOAL; LEAD MONOSILICATE 4; 5; 6; 6; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3170_9a20f6d6-97c7-40a8-af56-771247ff5784 48951-3170 HUMAN OTC DRUG Cuprum 8 Special Order Cuprum 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER 8 [hp_X]/mL N 20181231 48951-3171_559e353c-2ddf-16ba-e054-00144ff8d46c 48951-3171 HUMAN OTC DRUG Carbo Equiseti 6 Special Order Carbo Equiseti 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL 6 [hp_X]/mL N 20181231 48951-3172_5794c51c-1b40-52d9-e053-2a91aa0a7cec 48951-3172 HUMAN OTC DRUG Carbo Betulae cum Methano 3 Special Order Carbo Betulae cum Methano 3 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACTIVATED CHARCOAL 3 [hp_X]/g N 20181231 48951-3173_0c938709-1fc4-466d-a342-29005c606834 48951-3173 HUMAN OTC DRUG Cinis Urtica Ferro 6 Special Order Cinis Urtica Ferro 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; URTICA DIOICA; IRON 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3174_6dd933df-642c-4315-bf80-0ee43c49ccd7 48951-3174 HUMAN OTC DRUG Citrus pericarpium 10% Special Order Citrus pericarpium 10% Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON PEEL 1 [hp_X]/mL N 20181231 48951-3175_d6c0763f-7fdd-40c8-b797-1b613559e1cf 48951-3175 HUMAN OTC DRUG Cuprum aceticum Zincum valerianicum Special Order Cuprum aceticum Zincum valerianicum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC ACETATE; ZINC VALERATE DIHYDRATE 5; 5 [hp_X]/1; [hp_X]/1 N 20181231 48951-3176_09420a54-81fa-4d70-8982-c2735ab3385c 48951-3176 HUMAN OTC DRUG Citrus Cydonia Special Order Citrus Cydonia Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE 2; 3 [hp_X]/g; [hp_X]/g N 20181231 48951-3177_306f4e40-da4b-4d02-b4c9-f1b2ead782b0 48951-3177 HUMAN OTC DRUG Calendula 3 Special Order Calendula 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]/mL N 20181231 48951-3178_aaa75166-8284-4538-bbfb-232147f95c2c 48951-3178 HUMAN OTC DRUG Cinis comp A 21 Special Order Cinis comp A 21 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 21 [hp_X]/mL N 20181231 48951-3179_56e3aa45-03cf-45b0-e054-00144ff8d46c 48951-3179 HUMAN OTC DRUG Carduus Viscum Special Order Carduus Viscum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE; VISCUM ALBUM FRUITING TOP; MAMMAL LIVER 3; 4; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3181_132faa51-fa42-4ffe-8d73-3c7b89290c6a 48951-3181 HUMAN OTC DRUG Citrus Cydonia 1% Special Citrus Cydonia 1% Special LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON JUICE; QUINCE 2; 2 [hp_X]/mL; [hp_X]/mL N 20181231 48951-3184_544ac849-fc96-40d3-b4f4-99edc5d8d182 48951-3184 HUMAN OTC DRUG Jasper 17 Special Order Jasper 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 17 [hp_X]/mL N 20181231 48951-3185_5758fc0c-68b2-9392-e053-2a91aa0a4775 48951-3185 HUMAN OTC DRUG Calcium Phosphoricum 13 Special Order Calcium Phosphoricum 13 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM PHOSPHATE 13 [hp_X]/1 N 20181231 48951-3186_a9f7e099-2a82-41ef-85a0-58bcdeee6fa2 48951-3186 HUMAN OTC DRUG Camphor Hypericum Special Order Camphor Hypericum Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CAMPHOR (NATURAL); BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; ST. JOHN'S WORT; GOLD 2; 7; 7; 7; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3187_66732ceb-2d69-4ed7-bf8a-4fe66ed624c5 48951-3187 HUMAN OTC DRUG Connective Tissue 6 Special Order Connective Tissue 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS CONJUNCTIVA 6 [hp_X]/mL N 20181231 48951-3188_3fb43401-3051-4c40-9fb4-3f2759245a55 48951-3188 HUMAN OTC DRUG Chamomilla 10 Special order Chamomilla 10 Special order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHAMOMILE 1 [hp_X]/g N 20181231 48951-3189_f5d48688-b99c-4569-9e06-95006ee4d620 48951-3189 HUMAN OTC DRUG Coffea tosta 30 Special Order Coffea tosta 30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COFFEA ARABICA SEED, ROASTED 30 [hp_X]/1 N 20181231 48951-3190_42733955-43c5-4c69-93e6-940205b742b3 48951-3190 HUMAN OTC DRUG Cuprum 12 Special Order Cuprum 12 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER 12 [hp_X]/1 N 20181231 48951-3191_9104f6c0-86e9-4e39-95bc-e5cddd6a490f 48951-3191 HUMAN OTC DRUG Sapphire 30 Special Order Sapphire 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ALUMINUM OXIDE 30 [hp_X]/mL N 20181231 48951-3193_b35c17b5-a7dd-46fe-a9ec-ac4b8e1c3b21 48951-3193 HUMAN OTC DRUG Colchicum Sabina Special Order Colchicum Sabina Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. JUNIPER BERRY; COLCHICUM AUTUMNALE WHOLE 3; 4 [hp_X]/1; [hp_X]/1 N 20181231 48951-3194_34342573-bb52-4cd7-9489-dffbc7f1f735 48951-3194 HUMAN OTC DRUG Citrus Quartz Special Order Citrus Quartz Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON; QUINCE; SAMBUCUS NIGRA FLOWERING TOP; ELYMUS REPENS ROOT; LINDEN LEAF; LARIX DECIDUA RESIN; COLLOIDAL SILICON DIOXIDE 2; 2; 3; 4; 4; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3196_a5f74056-17ee-4f77-b151-6ed9af5fd298 48951-3196 HUMAN OTC DRUG Cinis Quercus 17 Special Order Cinis Quercus 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE 17 [hp_X]/mL N 20181231 48951-3197_3f162e69-19bc-485e-a499-aec940ae9875 48951-3197 HUMAN OTC DRUG Chamomilla e rad. 12 Special Order Chamomilla e rad. 12 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA 12 [hp_X]/1 N 20181231 48951-3198_0ed11784-d6fd-44d8-987f-dd88db60298b 48951-3198 HUMAN OTC DRUG Cimicifuga Cocculus Special Order Cimicifuga Cocculus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP; BLACK COHOSH; ANAMIRTA COCCULUS WHOLE; ZINC; STRYCHNOS IGNATII SEED 2; 3; 4; 4; 5; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3200_ff2d9691-a78a-4d5e-934a-5b3ef22c5883 48951-3200 HUMAN OTC DRUG Cartilago Betula Adult Size Special Order Cartilago Betula Adult Size Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; BOS TAURUS CARTILAGE; TIN; GOLD; ONION; FORMICA RUFA 5; 6; 8; 10; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3201_02a93fea-6550-4f81-8376-198a7ad98da4 48951-3201 HUMAN OTC DRUG Cartilago comp. Special Order Cartilago comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS CARTILAGE; ECHINACEA, UNSPECIFIED; EQUISETUM ARVENSE TOP; MANDRAGORA OFFICINARUM ROOT; TIN 5; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-3202_57d3cbbf-8487-b981-e053-2991aa0ab099 48951-3202 HUMAN OTC DRUG Cera Aesculus DKS Special Order Cera Aesculus DKS Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; EQUISETUM ARVENSE TOP; BRYONIA ALBA ROOT; FORMICA RUFA; GOLD; SEDUM ROSEUM WHOLE; TIN; ANTIMONY; VESPA CRABRO 1; 2; 3; 5; 6; 6; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3203_544d265c-e0f9-42b9-e054-00144ff8d46c 48951-3203 HUMAN OTC DRUG Calendula Calendula LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/mL N 20181231 48951-3204_544cf25d-5141-41d0-e054-00144ff8d46c 48951-3204 HUMAN OTC DRUG Calendula Thuja Calendula Thuja GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; ORIGANUM MAJORANA WHOLE; LILIUM LANCIFOLIUM WHOLE FLOWERING; THUJA OCCIDENTALIS WHOLE; WOOD CREOSOTE; PULSATILLA VULGARIS; SILVER; CANDIDA ALBICANS 2; 2; 2; 3; 3; 6; 6; 7; 33 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3205_54c1d306-dc31-2885-e054-00144ff8d46c 48951-3205 HUMAN OTC DRUG Borago Lavender Borago Lavender LOTION TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; BORAGE; MELILOTUS INDICUS SEED 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-3206_54c56ae7-35bd-6144-e054-00144ff8d46c 48951-3206 HUMAN OTC DRUG Carbo Chamomilla Carbo Chamomilla POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ACTIVATED CHARCOAL; WORMWOOD; MATRICARIA RECUTITA; GENTIANA LUTEA ROOT; AVENS EXTRACT; BLACK PEPPER; GINGER; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE 2; 3; 3; 3; 3; 3; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-4001_c5b4dd97-16ab-4398-95fa-cddd52d65a86 48951-4001 HUMAN OTC DRUG Daphne Mezereum 30 Special Order Daphne Mezereum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DAPHNE MEZEREUM WHOLE 30 [hp_X]/mL N 20181231 48951-4002_3500fae6-e832-4bdd-8f89-3ebf01fc3e19 48951-4002 HUMAN OTC DRUG Daphne mezereum 4 Daphne mezereum 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DAPHNE MEZEREUM WHOLE 4 [hp_X]/mL N 20181231 48951-4009_56e46345-d4ff-3ce6-e054-00144ff88e88 48951-4009 HUMAN OTC DRUG Drosera comp. Drosera comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DROSERA ROTUNDIFOLIA; ATROPA BELLADONNA; QUILLAJA SAPONARIA BARK; PROTORTONIA CACTI; HELLEBORUS FOETIDUS ROOT; IPECAC; MEPHITIS MEPHITIS ANAL GLAND FLUID; VERATRUM ALBUM ROOT 3; 4; 4; 4; 4; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4010_56e47247-b257-4258-e054-00144ff88e88 48951-4010 HUMAN OTC DRUG Dulcamara comp. Dulcamara comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; ARSENIC TRIOXIDE; SOLANUM DULCAMARA TOP; LOBELIA SPICATA LEAF 5; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4011_56e40c2d-3e00-45b2-e054-00144ff8d46c 48951-4011 HUMAN OTC DRUG Ear Formula Ear Formula LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEVISTICUM OFFICINALE ROOT; PAPRIKA; ATROPA BELLADONNA; PULSATILLA VULGARIS; ACONITUM NAPELLUS; SILICON DIOXIDE 2; 3; 6; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4012_30daaeee-7c9c-4919-afab-f8dace4add49 48951-4012 HUMAN OTC DRUG Echinacea Apis Child Size Echinacea Apis Child Size SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; MERCURIUS SOLUBILIS; SILVER 3; 3; 3; 17; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-4013_57fab597-501c-8437-e053-2a91aa0af98a 48951-4013 HUMAN OTC DRUG Echinacea Argentum Echinacea Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; ATROPA BELLADONNA; SILICON DIOXIDE; SILVER 3; 20; 20; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4014_5561b23b-d94a-6b6c-e054-00144ff88e88 48951-4014 HUMAN OTC DRUG Echinacea Argentum Echinacea Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; SILVER 3; 30 [hp_X]/mL; [hp_X]/mL N 20181231 48951-4015_576c38df-a20d-a521-e053-2a91aa0afa5f 48951-4015 HUMAN OTC DRUG Echinacea Argentum Echinacea Argentum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; SILVER 2; 30 [hp_X]/1; [hp_X]/1 N 20181231 48951-4017_55a1ec98-73bc-1b1e-e054-00144ff88e88 48951-4017 HUMAN OTC DRUG Echinacea e rad. 50 Echinacea e rad. 50 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA 1 [hp_X]/mL N 20181231 48951-4018_786da849-d703-4364-86df-abffc91aaf6a 48951-4018 HUMAN OTC DRUG Echinacea Essence Echinacea Essence LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA 1 [hp_X]/mL N 20181231 48951-4019_52f1c80f-1d8d-4476-8050-d3fc6faa0e31 48951-4019 HUMAN OTC DRUG Echinacea Quartz Gum Support Echinacea Quartz Gum Support GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ALTHAEA OFFICINALIS ROOT; ECHINACEA, UNSPECIFIED; ANTIMONY TRISULFIDE; SILVER; ATROPA BELLADONNA; COLLOIDAL SILICON DIOXIDE 2; 2; 5; 20; 20; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-4021_55a1fb3c-f035-2e39-e054-00144ff8d46c 48951-4021 HUMAN OTC DRUG Echinacea Thuja Echinacea Thuja LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EUCALYPTUS GUM; CHLOROPHYLL; ECHINACEA, UNSPECIFIED; THUJA OCCIDENTALIS WHOLE; APIS MELLIFERA; SILVER 1; 3; 3; 3; 6; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4023_002efdc6-6557-422e-a746-ed90f031945d 48951-4023 HUMAN OTC DRUG Echinacea Apis Adult Size Special Order Echinacea Apis Adult Size Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; MERCURIUS SOLUBILIS; SILVER 3; 3; 3; 17; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-4024_b807a6a8-7fd2-4102-bed4-344db1bcd311 48951-4024 HUMAN OTC DRUG Endometrium Argentum Special Order Endometrium Argentum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; SILVER; BEEF; COLLOIDAL SILICON DIOXIDE 2; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-4025_2f612b22-9fbb-4787-b8f8-9236b70c51a5 48951-4025 HUMAN OTC DRUG Equisetum Sulfur Special Order Equisetum Sulfur Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; SULFUR 15; 25 [hp_X]/mL; [hp_X]/mL N 20181231 48951-4026_4a7a0424-cb69-471e-8783-84478af008e3 48951-4026 HUMAN OTC DRUG Epiphysis 8 Epiphysis 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PINEAL GLAND 8 [hp_X]/mL N 20181231 48951-4027_55a2568d-8989-1c7a-e054-00144ff88e88 48951-4027 HUMAN OTC DRUG Epiphysis Plumbum Epiphysis Plumbum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PINEAL GLAND; HONEY; LEAD 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4028_576c38df-a200-a521-e053-2a91aa0afa5f 48951-4028 HUMAN OTC DRUG Epiphysis Plumbum Epiphysis Plumbum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PINEAL GLAND; HONEY; LEAD 8; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-4030_b5519c81-020e-4eb9-82b2-f8a0f32c25b5 48951-4030 HUMAN OTC DRUG Equisetum 10 Equisetum 10 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP 1 [hp_X]/g N 20181231 48951-4032_a8fc68b9-c5b9-4147-ab46-3cf83ca84b09 48951-4032 HUMAN OTC DRUG Ferrum phosphoricum 8 Special Order Ferrum phosphoricum 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROSOFERRIC PHOSPHATE 8 [hp_X]/mL N 20181231 48951-4034_1889b348-eacb-4600-892b-36dd40278ce3 48951-4034 HUMAN OTC DRUG Equisetum ex herba 15 Special Order Equisetum ex herba 15 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP 15 [hp_X]/mL N 20181231 48951-4035_55a28f15-b55a-3590-e054-00144ff88e88 48951-4035 HUMAN OTC DRUG Equisetum Formica Equisetum Formica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; EQUISETUM ARVENSE TOP 6; 17 [hp_X]/mL; [hp_X]/mL N 20181231 48951-4036_576d08c1-f2cb-569f-e053-2991aa0aa1f8 48951-4036 HUMAN OTC DRUG Equisetum Formica Equisetum Formica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; EQUISETUM ARVENSE TOP 6; 17 [hp_X]/1; [hp_X]/1 N 20181231 48951-4038_55a26c8f-19ee-4c96-e054-00144ff8d46c 48951-4038 HUMAN OTC DRUG Equisetum limosum Rubellite 30 Equisetum limosum Rubellite 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; SILICON DIOXIDE 30; 30 [hp_X]/mL; [hp_X]/mL N 20181231 48951-4039_56e5ed78-968c-6daf-e054-00144ff88e88 48951-4039 HUMAN OTC DRUG Equisetum Silicea Equisetum Silicea LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; SILICON DIOXIDE 3; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-4040_55a28f15-b56d-3590-e054-00144ff88e88 48951-4040 HUMAN OTC DRUG Equisetum Stannum Equisetum Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN; EQUISETUM ARVENSE TOP 8; 17 [hp_X]/mL; [hp_X]/mL N 20181231 48951-4041_0c4fdb60-7280-4502-a5c4-06cb0003a8b5 48951-4041 HUMAN OTC DRUG Equisetum Stannum Special Order Equisetum Stannum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN; EQUISETUM ARVENSE TOP 8; 17 [hp_X]/1; [hp_X]/1 N 20181231 48951-4042_d06477de-8a32-4fc0-a891-d690d4aaf45a 48951-4042 HUMAN OTC DRUG Equisetum Viscum Equisetum Viscum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; PORK KIDNEY; VISCUM ALBUM FRUITING TOP 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4043_576d08c1-f2bf-569f-e053-2991aa0aa1f8 48951-4043 HUMAN OTC DRUG Equisetum Viscum Equisetum Viscum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; PORK KIDNEY; VISCUM ALBUM FRUITING TOP 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-4044_e7d2372e-f533-4c71-b32d-52b90de8f91b 48951-4044 HUMAN OTC DRUG Erythrocytes 6 Erythrocytes 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS RED BLOOD CELL 6 [hp_X]/mL N 20181231 48951-4046_576d08c1-f2b2-569f-e053-2991aa0aa1f8 48951-4046 HUMAN OTC DRUG Eucalyptus Cuprum sulf. Eucalyptus Cuprum sulf. PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EUCALYPTUS GUM; CUPRIC SULFATE 1; 5 [hp_X]/1; [hp_X]/1 N 20181231 48951-4047_30bb27e9-3778-4d5e-a893-fae1fd8afd7e 48951-4047 HUMAN OTC DRUG Eucalyptus Cuprum sulfuricum Special Order Eucalyptus Cuprum sulfuricum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EUCALYPTUS GUM; CUPRIC SULFATE 1; 6 [hp_X]/mL; [hp_X]/mL N 20181231 48951-4048_6fcdc0c5-e533-4c63-97d4-aaef46b4483a 48951-4048 HUMAN OTC DRUG Eucalyptus e fol. 5 Eucalyptus e fol. 5 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EUCALYPTUS GUM 5 [hp_X]/mL N 20181231 48951-4049_55a2b94a-ef6c-646f-e054-00144ff8d46c 48951-4049 HUMAN OTC DRUG Eupatorium comp. Eupatorium comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EUPATORIUM PERFOLIATUM FLOWERING TOP; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; PHOSPHORUS; LACHESIS MUTA VENOM 5; 6; 6; 7; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4051_57fb353e-cf44-103c-e053-2a91aa0a8c21 48951-4051 HUMAN OTC DRUG Euphrasia Euphrasia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Euphrasia EUPHRASIA STRICTA 3 [hp_X]/mL N 20181231 48951-4054_57976239-91ca-9e21-e053-2991aa0a2a13 48951-4054 HUMAN OTC DRUG Ferrum 5 Ferrum 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 5 [hp_X]/g N 20181231 48951-4055_8763d410-d249-44a0-9c12-6f93cb956dd5 48951-4055 HUMAN OTC DRUG Ferum Acidum cholalicum 4 Special Order Ferum Acidum cholalicum 4 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHOLIC ACID; FERROUS GLUCONATE; HONEY 4; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-4056_285f9663-84b1-42d2-9ecd-43a96b8b20c2 48951-4056 HUMAN OTC DRUG Ferrum arsenicosum 30 Special Order Ferrum arsenicosum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROUS ARSENATE 30 [hp_X]/mL N 20181231 48951-4057_55a2ff2e-bb7d-6e8f-e054-00144ff8d46c 48951-4057 HUMAN OTC DRUG Ferrum arsenicosum 6 Ferrum arsenicosum 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROUS ARSENATE 6 [hp_X]/mL N 20181231 48951-4059_579510d4-d61b-4670-e053-2991aa0a51e5 48951-4059 HUMAN OTC DRUG Ferrum phosphoricum 6 Ferrum phosphoricum 6 POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROSOFERRIC PHOSPHATE 6 [hp_X]/g N 20181231 48951-4060_57951914-f517-5e13-e053-2a91aa0aa374 48951-4060 HUMAN OTC DRUG Equisetum cum sulfure tosta 6 Equisetum cum sulfure tosta 6 POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; SULFUR 6; 6 [hp_X]/1; [hp_X]/1 N 20181231 48951-4062_55a2ff2e-bbd5-6e8f-e054-00144ff8d46c 48951-4062 HUMAN OTC DRUG Ferrum Quartz Ferrum Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SANGUINARIA CANADENSIS ROOT; SULFUR; IRON; SILICON DIOXIDE 6; 6; 8; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4064_56e5d8df-83b6-3610-e054-00144ff8d46c 48951-4064 HUMAN OTC DRUG Ferrum rosatum Graphites Ferrum rosatum Graphites LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SEDUM ROSEUM WHOLE; FERRIC OXIDE RED; IRON; GRAPHITE 3; 3; 6; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4065_d9361333-1ac4-423f-91ba-f3a17e6efd51 48951-4065 HUMAN OTC DRUG Ferrum sidereum Pancreas 10/4 Ferrum sidereum Pancreas 10/4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA PANCREAS; IRON 4; 10 [hp_X]/mL; [hp_X]/mL N 20181231 48951-4066_3aa7e04f-ee9c-4744-bbec-65520b8c3447 48951-4066 HUMAN OTC DRUG Ferrum sidereum 20 Ferrum sidereum 20 TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 20 [hp_X]/1 N 20181231 48951-4067_2b33112e-7e28-44b4-a937-4eb39cd95f3f 48951-4067 HUMAN OTC DRUG Ferrum sidereum 21 Special Order Ferrum sidereum 21 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 21 [hp_X]/mL N 20181231 48951-4068_ba9675b7-6ece-424e-89f0-d0aef1c454e3 48951-4068 HUMAN OTC DRUG Ferrum sidereum 30 Special Order Ferrum sidereum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 30 [hp_X]/mL N 20181231 48951-4070_55a3a9b3-bfb3-5f67-e054-00144ff88e88 48951-4070 HUMAN OTC DRUG Ferrum sidereum 6 Ferrum sidereum 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 6 [hp_X]/mL N 20181231 48951-4071_55a3a9b3-bfc3-5f67-e054-00144ff88e88 48951-4071 HUMAN OTC DRUG Ferrum sidereum Sulfur Ferrum sidereum Sulfur LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SULFUR; IRON; SILICON DIOXIDE 6; 8; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4072_bf9d9b31-9e4c-417c-859d-62967fd55ed1 48951-4072 HUMAN OTC DRUG Ferrum sidereum 21 Special Order Ferrum sidereum 21 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 21 [hp_X]/mL N 20181231 48951-4073_579510d4-d60d-4670-e053-2991aa0a51e5 48951-4073 HUMAN OTC DRUG Ferrum sidereum 6 Ferrum sidereum 6 POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 6 [hp_X]/g N 20181231 48951-4074_55b335a8-d026-6bb6-e054-00144ff88e88 48951-4074 HUMAN OTC DRUG Ferrum silicicum Urtica Ferrum silicicum Urtica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANISE; URTICA DIOICA; FERRIC OXIDE RED; SILICON DIOXIDE 3; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4075_576ca7c0-cb6a-2911-e053-2a91aa0af95e 48951-4075 HUMAN OTC DRUG Ferrum silicicum Urtica Ferrum silicicum Urtica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANISE; URTICA DIOICA ROOT; FERRIC OXIDE RED; SILICON DIOXIDE 3; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-4076_5794ea28-d6d8-4344-e053-2991aa0a66fc 48951-4076 HUMAN OTC DRUG Ferrum silicicum Urtica Ferrum silicicum Urtica POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. URTICA DIOICA; FERRIC OXIDE RED; SILICON DIOXIDE 2; 3; 5 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-4077_56e5e687-b1ab-6b43-e054-00144ff88e88 48951-4077 HUMAN OTC DRUG Flores Formica Flores Formica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; VESPA CRABRO; WHEAT 6; 6; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4081_43494917-73f4-4d6f-bb4b-fd4a27bfccf8 48951-4081 HUMAN OTC DRUG Formic acid 1 Special Order Formic acid 1 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMIC ACID 2 [hp_X]/mL N 20181231 48951-4082_56e590d1-94dc-0bad-e054-00144ff8d46c 48951-4082 HUMAN OTC DRUG Formica 3 Formica 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 3 [hp_X]/mL N 20181231 48951-4083_0b6dbd3f-1b9f-4b84-81bc-013318b822a8 48951-4083 HUMAN OTC DRUG Fomica 7 Special Order Fomica 7 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 7 [hp_X]/mL N 20181231 48951-4084_55a41a36-943b-2921-e054-00144ff8d46c 48951-4084 HUMAN OTC DRUG Formica Apis Formica Apis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; FORMICA RUFA 3; 3 [hp_X]/mL; 1/mL N 20181231 48951-4085_576d6995-1ffe-36af-e053-2991aa0a2944 48951-4085 HUMAN OTC DRUG Formica Apis Formica Apis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; FORMICA RUFA 3; 3 [hp_X]/1; [hp_X]/1 N 20181231 48951-4086_55a41a36-9448-2921-e054-00144ff8d46c 48951-4086 HUMAN OTC DRUG Formica Arnica Formica Arnica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; FORMICA RUFA; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE 3; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4087_576d6995-1ff1-36af-e053-2991aa0a2944 48951-4087 HUMAN OTC DRUG Formica Arnica Formica Arnica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; FORMICA RUFA; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE 3; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-4088_55a40688-7654-6e7b-e054-00144ff88e88 48951-4088 HUMAN OTC DRUG Formica ex animale 4 Formica ex animale 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 4 [hp_X]/mL N 20181231 48951-4089_aaae80d4-44de-4098-bf3c-0c19cd778260 48951-4089 HUMAN OTC DRUG Formica Oxalis Formica Oxalis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS MONTANA LEAF; FORMICA RUFA 3; 5 [hp_X]/mL; [hp_X]/mL N 20181231 48951-4090_576d6995-1fe5-36af-e053-2991aa0a2944 48951-4090 HUMAN OTC DRUG Formica Oxalis Formica Oxalis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS ACETOSELLA LEAF; FORMICA RUFA 3; 5 [hp_X]/1; [hp_X]/1 N 20181231 48951-4092_0cfddf89-f40b-4e16-99c9-daf647a23acc 48951-4092 HUMAN OTC DRUG Fragaria Vitis Liver Support Fragaria Vitis Liver Support LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FRAGARIA VESCA WHOLE; HONEY; VITIS VINIFERA LEAF 2; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4095_a2d08a2a-e075-422d-90e3-182ead01b2fb 48951-4095 HUMAN OTC DRUG Ferrum sidereum 20 Ferrum sidereum 20 POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 20 [hp_X]/g N 20181231 48951-4096_55b23c35-7f24-4521-e054-00144ff88e88 48951-4096 HUMAN OTC DRUG Formica ex animale 3/15 Formica ex animale 3/15 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 3 [hp_X]/mL N 20181231 48951-4097_3ed7dcfe-ef2e-48d4-b690-a977ac26c054 48951-4097 HUMAN OTC DRUG Dioscorea batata Special Order Dioscorea batata Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MYRRH; FRANKINCENSE; GOLD; CHINESE YAM 9; 9; 12; 16 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-4098_576ca7c0-cb2b-2911-e053-2a91aa0af95e 48951-4098 HUMAN OTC DRUG Dioscorea batata 16 Special Order Dioscorea batata 16 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHINESE YAM 16 [hp_X]/1 N 20181231 48951-4099_1943586f-b095-4854-a916-ab5ac97955fc 48951-4099 HUMAN OTC DRUG Echinacea Thuja Special Order Echinacea Thuja Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EUCALYPTUS GUM; CHLOROPHYLL; ECHINACEA, UNSPECIFIED; THUJA OCCIDENTALIS WHOLE; APIS MELLIFERA; SILVER 1; 3; 3; 3; 6; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4100_add5f6f1-e14c-42df-a999-f200ab61fb81 48951-4100 HUMAN OTC DRUG Ferrum sidereum Pancreas 10/4 Special Order Ferrum sidereum Pancreas 10/4 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA PANCREAS; IRON 4; 10 [hp_X]/1; [hp_X]/1 N 20181231 48951-4101_576d08c1-f2a3-569f-e053-2991aa0aa1f8 48951-4101 HUMAN OTC DRUG Ferrum phos. 6 Special Order Ferrum phos. 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 6 [hp_X]/1 N 20181231 48951-4102_e1df8dff-c26f-48fe-88a9-b7448713c3dd 48951-4102 HUMAN OTC DRUG Formica Stibium comp. Special Order Formica Stibium comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA LUNG; ANTIMONY; COLLOIDAL SILICON DIOXIDE; FORMICA RUFA 6; 8; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4103_4730618a-c415-4cd2-bf5a-23ca20fad7a4 48951-4103 HUMAN OTC DRUG Ferrum rosatum Graphites Special Order Ferrum rosatum Graphites Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SEDUM ROSEUM WHOLE; FERRIC OXIDE RED; IRON; GRAPHITE 3; 3; 6; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-4104_a83dced4-0f2e-47c8-a315-fd6d1ef6b5b2 48951-4104 HUMAN OTC DRUG Ferrum 8 Special Order Ferrum 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 8 [hp_X]/mL N 20181231 48951-4105_0fd89d87-cae6-476a-bc7c-380a20f8ae99 48951-4105 HUMAN OTC DRUG Eucalyptus comp. Special Order Eucalyptus comp. Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DROSERA ROTUNDIFOLIA; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-4106_576ca7c0-cb47-2911-e053-2a91aa0af95e 48951-4106 HUMAN OTC DRUG Flores Formica Special Order Flores Formica Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; VESPA CRABRO; WHEAT 6; 6; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-4107_09e3d6f4-cc8b-4fe1-af13-42367022b754 48951-4107 HUMAN OTC DRUG Formica 60 Special Order Formica 60 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 60 [hp_X]/mL N 20181231 48951-4108_6cd594bc-98bb-4bda-8f34-64a8d3d2ec5d 48951-4108 HUMAN OTC DRUG Ferrum picrinicum 8 Special Order Ferrum picrinicum 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROUS PICRATE 8 [hp_X]/mL N 20181231 48951-4109_0d854bf0-a54c-432d-bab3-d212c62c6309 48951-4109 HUMAN OTC DRUG Equisetum ex herba 30 Special Order Equisetum ex herba 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP 30 [hp_X]/mL N 20181231 48951-4110_55a40688-760e-6e7b-e054-00144ff88e88 48951-4110 HUMAN OTC DRUG Formica 6 Special Order Formica 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 6 [hp_X]/mL N 20181231 48951-4111_6eadebee-5727-49aa-b795-bc0044775a8b 48951-4111 HUMAN OTC DRUG Funiculus umbilicalis 30 Special Order Funiculus umbilicalis 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA UMBILICAL CORD 30 [hp_X]/mL N 20181231 48951-4112_7f53d6c2-5eaa-45ed-8ea6-d3f23229230d 48951-4112 HUMAN OTC DRUG Dioscorea batata Prunus Special Order Dioscorea batata Prunus Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; SLOE; MYRRH; FRANKINCENSE; GOLD; CHINESE YAM 5; 5; 9; 9; 12; 16 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-4113_e61dbde8-ea05-4437-a281-f2a4298ffcdf 48951-4113 HUMAN OTC DRUG Formica 12 Special Order Formica 12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 12 [hp_X]/mL N 20181231 48951-4114_d1c436f9-f205-4ad5-b141-e997a2c5cc4b 48951-4114 HUMAN OTC DRUG Ferrum 8 Special Order Ferrum 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 8 [hp_X]/1 N 20181231 48951-4115_c4a3b8d9-0333-4e28-af39-4108acfa0049 48951-4115 HUMAN OTC DRUG Equisetum ex herba 1 Special Order Equisetum ex herba 1 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP 2 [hp_X]/1 N 20181231 48951-4116_756d5ecc-8efd-40aa-a39d-1af160bfea21 48951-4116 HUMAN OTC DRUG Formica 30 Special Order Formica 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 30 [hp_X]/mL N 20181231 48951-4117_56e5d8df-83a8-3610-e054-00144ff8d46c 48951-4117 HUMAN OTC DRUG Ferrum sidereum 6 Special Order Ferrum sidereum 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON 6 [hp_X]/mL N 20181231 48951-4118_d1fce0ab-85b7-441d-a0d0-e64dc7bd7dca 48951-4118 HUMAN OTC DRUG Echinacea e rad. 3 Special Order Echinacea e rad. 3 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA 3 [hp_X]/1 N 20181231 48951-4119_55a2e78a-7f63-6be7-e054-00144ff8d46c 48951-4119 HUMAN OTC DRUG Femur 9 Special Order Femur 9 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE 9 [hp_X]/mL N 20181231 48951-4121_2e44ad2e-6e4c-4565-8d31-ab8a86c23221 48951-4121 HUMAN OTC DRUG Formica 3 Special Order Formica 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA 3 [hp_X]/mL N 20181231 48951-4122_7f03291c-1551-46cd-af98-2e5b372e8797 48951-4122 HUMAN OTC DRUG Funiculus umbilicalis 6 Special Order Funiculus umbilicalis 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA UMBILICAL CORD 6 [hp_X]/mL N 20181231 48951-4124_57e5517f-afc9-540c-e053-2991aa0a6a07 48951-4124 HUMAN OTC DRUG Disci Viscum Comp. cum Stanno DKS Special Order Disci Viscum Comp. cum Stanno DKS Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; URTICA DIOICA; VESPA CRABRO; COPPER; BAMBUSA VULGARIS WHOLE; BOS TAURUS INTERVERTEBRAL DISC; EQUISETUM ARVENSE TOP; TIN; VISCUM ALBUM FRUITING TOP 3; 3; 6; 8; 12; 12; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-4128_544a27c6-726e-1717-e054-00144ff88e88 48951-4128 HUMAN OTC DRUG Fragaria Vitis Fragaria Vitis TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FRAGARIA VESCA WHOLE; VITIS VINIFERA LEAF 1; 1 [hp_X]/1; [hp_X]/1 N 20181231 48951-4129_54480bec-88aa-2897-e054-00144ff8d46c 48951-4129 HUMAN OTC DRUG Equisteum Iris Equisteum Iris OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP; EQUISETUM ARVENSE TOP; C12-17 ALKANE; SULFUR 2; 2; 2; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-4131_549e48a5-be58-0042-e054-00144ff8d46c 48951-4131 HUMAN OTC DRUG Echinacea Quartz Echinacea Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; ANTIMONY TRISULFIDE; SILVER; ATROPA BELLADONNA; SILICON DIOXIDE 3; 6; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-4132_55108ffd-d6c8-41de-e054-00144ff88e88 48951-4132 HUMAN OTC DRUG Ferrum Quartz Pellets Ferrum Quartz Pellets PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc IRON; SANGUINARIA CANADENSIS ROOT; SULFUR; SILICON DIOXIDE 8; 6; 6; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-4133_5513d8a3-311b-5259-e054-00144ff8d46c 48951-4133 HUMAN OTC DRUG Echinacea Thuja Echinacea Thuja PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc EUCALYPTUS GLOBULUS LEAF; ECHINACEA PALLIDA; THUJA OCCIDENTALIS LEAFY TWIG; APIS MELLIFERA; SILVER NITRATE 1; 3; 3; 6; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-4134_54c23582-efdc-3d9d-e054-00144ff8d46c 48951-4134 HUMAN OTC DRUG Ferrum Quartz Ferrum Quartz TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROUS CATION; SULFUR 1; 1 [hp_X]/1; [hp_X]/1 N 20181231 48951-4135_555129d9-bd97-3b69-e054-00144ff8d46c 48951-4135 HUMAN OTC DRUG Echincaea Calendula Echinacea Calendula GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; CALENDULA OFFICINALIS FLOWERING TOP; LARIX DECIDUA RESIN; VISCUM ALBUM FRUITING TOP; CUPRIC ACETATE; SILVER; SUS SCROFA SKIN; SUS SCROFA UMBILICAL CORD; BOS TAURUS PLACENTA 1; 1; 1; 3; 6; 7; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-5001_55b2b35f-4765-1cc2-e054-00144ff8d46c 48951-5001 HUMAN OTC DRUG Galena Larix Special Order Galena Larix Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CLAVICEPS PURPUREA SCLEROTIUM; LARIX DECIDUA RESIN; BOS TAURUS EYE; LEAD SULFIDE 6; 10; 12; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5002_576d2667-c0d6-3f1d-e053-2a91aa0ab94b 48951-5002 HUMAN OTC DRUG Galena Larix Galena Larix PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS EYE; LARIX DECIDUA RESIN; CLAVICEPS PURPUREA SCLEROTIUM; LEAD SULFIDE 6; 6; 6; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-5004_55b289e4-f1d7-57f5-e054-00144ff88e88 48951-5004 HUMAN OTC DRUG Gelsemium Bryonia Gelsemium Bryonia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; FERROSOFERRIC PHOSPHATE 3; 3; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5007_38746455-8eb4-4d0c-af57-f0d4c6f34cc4 48951-5007 HUMAN OTC DRUG Gentiana Absinthium Gentiana Absinthium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. WORMWOOD; GENTIANA LUTEA ROOT; TARAXACUM PALUSTRE ROOT; STRYCHNOS NUX-VOMICA SEED 3; 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5008_576d2667-c0c8-3f1d-e053-2a91aa0ab94b 48951-5008 HUMAN OTC DRUG Gentiana Absinthium Gentiana Absinthium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. WORMWOOD; GENTIANA LUTEA ROOT; TARAXACUM PALUSTRE ROOT; STRYCHNOS NUX-VOMICA SEED 1; 1; 2; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-5009_56e565ef-f3a1-5cd4-e054-00144ff88e88 48951-5009 HUMAN OTC DRUG Geum urbanum e rad. 5 Geum urbanum e rad. 5 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GEUM URBANUM ROOT 1 [hp_X]/mL N 20181231 48951-5011_56e5950a-49f5-645f-e054-00144ff88e88 48951-5011 HUMAN OTC DRUG Gl. suprarenales Gl. thyreoidea Hypophysis Gl. suprarenales Gl. thyreoidea Hypophysis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYROID 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5012_55b448b7-9931-1571-e054-00144ff88e88 48951-5012 HUMAN OTC DRUG Glandula Thymus 4 Glandula Thymus 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS THYMUS 4 [hp_X]/mL N 20181231 48951-5013_5a920c39-bf24-41d9-96fe-ece3c368aa81 48951-5013 HUMAN OTC DRUG Glandula thymus 6 Special Order Glandula thymus 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy inc. BOS TAURUS THYMUS 6 [hp_X]/mL N 20181231 48951-5014_bbdb895d-e977-4a97-94bf-75ec8969a79a 48951-5014 HUMAN OTC DRUG Glandula thyreoidea 3 Special Order Glandula thyreoidea 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THYROID, UNSPECIFIED 3 [hp_X]/mL N 20181231 48951-5016_55b487e1-9263-6ac6-e054-00144ff8d46c 48951-5016 HUMAN OTC DRUG Glandula thyreoidea 8 Glandula thyreoidea 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THYROID, UNSPECIFIED 8 [hp_X]/mL N 20181231 48951-5019_55b2dcd2-e265-1c82-e054-00144ff8d46c 48951-5019 HUMAN OTC DRUG Glandulae suprarenales 4 Glandulae suprarenales 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND 4 [hp_X]/mL N 20181231 48951-5020_56f46465-d327-0972-e054-00144ff8d46c 48951-5020 HUMAN OTC DRUG Glandulae suprarenales 6 Special Order Glandulae suprarenales 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND 6 [hp_X]/mL N 20181231 48951-5021_55b2b35f-477e-1cc2-e054-00144ff8d46c 48951-5021 HUMAN OTC DRUG Glandulae suprarenales 6 Glandulae suprarenales 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND 6 [hp_X]/mL N 20181231 48951-5022_ce5a62d0-bfce-46b4-b065-776ad01e0e70 48951-5022 HUMAN OTC DRUG Glandulae suprarenales 8 Special Order Glandulae suprarenales 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND 8 [hp_X]/mL N 20181231 48951-5023_55b406b6-6c2e-17a8-e054-00144ff88e88 48951-5023 HUMAN OTC DRUG Glandulae Suprarenales Lien Glandulae Suprarenales Lien LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS GALLBLADDER; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5024_576e0a0c-5f6d-3946-e053-2991aa0a9bab 48951-5024 HUMAN OTC DRUG Glandulae suprarenales Lien Glandulae suprarenales Lien PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BILE; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-5027_55b481a7-69b0-288b-e054-00144ff88e88 48951-5027 HUMAN OTC DRUG Gnaphalium Stannum Gnaphalium Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS CEREBELLUM; BOS TAURUS BRAIN; BOS TAURUS PINEAL GLAND; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; SUS SCROFA EAR; BOS TAURUS NERVE; BIFENTHRIN; TIN 17; 17; 17; 17; 17; 17; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5028_576e0a0c-5f60-3946-e053-2991aa0a9bab 48951-5028 HUMAN OTC DRUG Gnaphalium Stannum Gnaphalium Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS CEREBELLUM; BOS TAURUS BRAIN; BOS TAURUS PINEAL GLAND; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; SUS SCROFA EAR; BOS TAURUS NERVE; BIFENTHRIN; TIN 17; 17; 17; 17; 17; 17; 20; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-5030_8ea24680-6d7d-4bb7-8f42-21ed2c577491 48951-5030 HUMAN OTC DRUG Hamamelis e cortex 3 Hamamelis e cortex 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAMAMELIS VIRGINIANA TOP 3 [hp_X]/mL N 20181231 48951-5031_55b4a125-6018-6be3-e054-00144ff8d46c 48951-5031 HUMAN OTC DRUG Hamamelis Aesculus Hamamelis Aesculus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; HAMAMELIS VIRGINIANA TOP; PAEONIA OFFICINALIS ROOT; PULSATILLA VULGARIS; HIRUDIN; MERCURY 3; 3; 3; 3; 6; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5032_21d13ed9-a64d-4f7f-80a2-80fb7685f1ee 48951-5032 HUMAN OTC DRUG Hamamelis Aesculus Hamamelis Aesculus CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; MILK THISTLE; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; KRAMERIA LAPPACEA WHOLE; NITRIC ACID; ARNICA MONTANA; CALCIUM FLUORIDE; SEPIA OFFICINALIS JUICE; ACTIVATED CHARCOAL 2; 2; 2; 2; 2; 7; 7; 9; 9; 11 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-5033_de464fb6-17d0-4108-81d5-d5adeeef7c6c 48951-5033 HUMAN OTC DRUG Hypophysis 6 Hypophysis 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND 6 [hp_X]/mL N 20181231 48951-5037_55b4a125-602b-6be3-e054-00144ff8d46c 48951-5037 HUMAN OTC DRUG Helleborus e pl. tota 2 Helleborus e pl. tota 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HELLEBORUS FOETIDUS ROOT 2 [hp_X]/mL N 20181231 48951-5038_55b4a125-6038-6be3-e054-00144ff8d46c 48951-5038 HUMAN OTC DRUG Helleborus e pl. tota 4 Helleborus e pl. tota 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HELLEBORUS FOETIDUS ROOT 4 [hp_X]/mL N 20181231 48951-5039_55c5f5db-a1f6-0550-e054-00144ff88e88 48951-5039 HUMAN OTC DRUG Hepar 6 Special Order Hepar 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER 6 [hp_X]/mL N 20181231 48951-5040_55c5df85-078e-7364-e054-00144ff88e88 48951-5040 HUMAN OTC DRUG Hepar Magnesium 10 Special Order Hepar Magnesium 10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; MAGNESIUM HYDROXIDE 10; 10 [hp_X]/mL; [hp_X]/mL N 20181231 48951-5041_55c5f5db-a204-0550-e054-00144ff88e88 48951-5041 HUMAN OTC DRUG Hepar Magnesium 4 Hepar Magnesium 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; MAGNESIUM HYDROXIDE 4; 4 [hp_X]/mL; [hp_X]/mL N 20181231 48951-5042_56f46465-d31a-0972-e054-00144ff8d46c 48951-5042 HUMAN OTC DRUG Hepar Magnesium 4 Hepar Magnesium 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; MAGNESIUM CATION 4; 4 [hp_X]/mL; [hp_X]/mL N 20181231 48951-5044_56f44dcc-a8f4-4ae9-e054-00144ff88e88 48951-5044 HUMAN OTC DRUG Hepar Magnesium Taraxicum 4 Hepar Magnesium 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; MAGNESIUM HYDROXIDE; TARAXACUM PALUSTRE ROOT 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5045_55c5dfc4-375a-6ac2-e054-00144ff88e88 48951-5045 HUMAN OTC DRUG Hepar Stannum 17/20 Hepar Stannum 17/20 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; TIN 17; 20 [hp_X]/mL; [hp_X]/mL N 20181231 48951-5046_576db6ba-c287-ebde-e053-2a91aa0aab51 48951-5046 HUMAN OTC DRUG Hepar Stannum 17/20 Hepar Stannum 17/20 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; TIN 17; 20 [hp_X]/1; [hp_X]/1 N 20181231 48951-5047_55c53f81-941e-33e1-e054-00144ff8d46c 48951-5047 HUMAN OTC DRUG Hepar Stannum 6/10 Heppar Stannum 6/10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; TIN 6; 10 [hp_X]/mL; [hp_X]/mL N 20181231 48951-5048_576db6ba-c279-ebde-e053-2a91aa0aab51 48951-5048 HUMAN OTC DRUG Hepar Stannum 6/10 Hepar Stannum 6/10 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; TIN 6; 10 [hp_X]/1; [hp_X]/1 N 20181231 48951-5049_024e7c4a-1fca-4235-bd95-0702f34bf537 48951-5049 HUMAN PRESCRIPTION DRUG Hepar sulfuris Sinus Hepar sulfuris Sinus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM SULFIDE; BOS TAURUS NASAL MUCOSA 6; 8 [hp_X]/mL; [hp_X]/mL N 20181231 48951-5050_576daa14-526c-dd3c-e053-2a91aa0aedad 48951-5050 HUMAN OTC DRUG Hepar sulfuris Sinus Hepar sulfuris Sinus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM SULFIDE; BOS TAURUS NASAL MUCOSA 6; 8 [hp_X]/1; [hp_X]/1 N 20181231 48951-5053_56f4b751-4201-571e-e054-00144ff88e88 48951-5053 HUMAN OTC DRUG Hepar Magnesium 6 Special Order Hepar Magnesium 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; MAGNESIUM HYDROXIDE 6; 6 [hp_X]/mL; [hp_X]/mL N 20181231 48951-5060_56f41733-85b4-4666-e054-00144ff88e88 48951-5060 HUMAN OTC DRUG Hypericum Bryophyllum Hypericum Bryophyllum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ST. JOHN'S WORT; KALANCHOE DAIGREMONTIANA LEAF; MILK THISTLE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE 1; 2; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5061_576db6ba-c261-ebde-e053-2a91aa0aab51 48951-5061 HUMAN OTC DRUG Hypericum Bryophyllum Hypericum Bryophyllum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ST. JOHN'S WORT; KALANCHOE DAIGREMONTIANA LEAF; MILK THISTLE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE 1; 2; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-5062_55c66edc-3e41-027b-e054-00144ff8d46c 48951-5062 HUMAN OTC DRUG Hypericum ex herba 3 Hypericum ex herba 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ST. JOHN'S WORT 3 [hp_X]/mL N 20181231 48951-5065_e4a803fa-cdb2-488a-8a27-3c2f5fd8e1e8 48951-5065 HUMAN OTC DRUG Hamamelis Aesculus Varicose Relief AESCULUS GLABRA NUT - HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - PAEONIA OFFICINALIS ROOT - PULSATILLA VULGARIS - DESIRUDIN - MERCURY - PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc AESCULUS GLABRA NUT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PAEONIA OFFICINALIS ROOT; PULSATILLA VULGARIS; DESIRUDIN; MERCURY 3; 3; 3; 3; 6; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-5066_85f08638-f166-42ab-b11c-a3c099e6bbaf 48951-5066 HUMAN OTC DRUG Hypophysis Stannum Special Order Hypophysis Stannum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND; TIN 8; 20 [hp_X]/mL; [hp_X]/mL N 20181231 48951-5067_576e0a0c-5f9b-3946-e053-2991aa0a9bab 48951-5067 HUMAN OTC DRUG Hypophysis Stannum Hypophysis Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND; TIN 8; 20 [hp_X]/1; [hp_X]/1 N 20181231 48951-5068_c2070a62-8fb5-44a9-9af4-53a222f78482 48951-5068 HUMAN OTC DRUG Ignatia Bryophyllum Ignatia Bryophyllum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; STRYCHNOS IGNATII SEED; SILVER; LACHESIS MUTA VENOM 3; 4; 10; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5069_576e9282-5186-6536-e053-2a91aa0a6a4f 48951-5069 HUMAN OTC DRUG Ignatia Bryophyllum Ignatia Bryophyllum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; STRYCHNOS IGNATII SEED; SILVER; LACHESIS MUTA VENOM 3; 4; 10; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-5070_d1760ac3-92a0-4406-ad56-9c184085157f 48951-5070 HUMAN OTC DRUG Immunodoron Immunodoron LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MELISSA OFFICINALIS; HYOSCYAMUS NIGER LEAF; ATROPA BELLADONNA 2; 5; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5071_55c75dc9-1ed3-2481-e054-00144ff8d46c 48951-5071 HUMAN OTC DRUG Iris germanica comp. Iris germanica comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; CENTAUREA BENEDICTA; C12-17 ALKANE; PAEONIA OFFICINALIS ROOT; POTASSIUM CARBONATE; BEEF HEART; GOLD; ARNICA MONTANA 3; 3; 4; 4; 5; 6; 10; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5072_56f43d5f-e2e3-522b-e054-00144ff8d46c 48951-5072 HUMAN OTC DRUG Iris germanica comp. Iris germanica comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; CENTAUREA BENEDICTA; C12-17 ALKANE; PAEONIA OFFICINALIS ROOT; POTASSIUM CARBONATE; BEEF HEART; GOLD; ARNICA MONTANA 3; 4; 4; 4; 5; 6; 10; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5073_5438ff7f-9da6-2c96-e054-00144ff88e88 48951-5073 HUMAN OTC DRUG Glandula thyreoidea 6 Special Order Glandula thyreoidea 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THYROID, UNSPECIFIED 6 [hp_X]/mL N 20181231 48951-5074_79ff57e5-a2d8-4ea9-85f3-2936f9dc4031 48951-5074 HUMAN OTC DRUG Gl. Supra Gl. Thyr Hypophysis 6 Special Order Gl. Supra Gl. Thyr Hypophysis 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; THYROID, UNSPECIFIED; BOS TAURUS PITUITARY GLAND 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-5075_55c66edc-3e35-027b-e054-00144ff8d46c 48951-5075 HUMAN OTC DRUG Hepar sulfuris Sinus Special Order Hepar sulfuris Sinus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM SULFIDE; BOS TAURUS NASAL MUCOSA 6; 15 [hp_X]/mL; [hp_X]/mL N 20181231 48951-5076_576db6ba-c26e-ebde-e053-2a91aa0aab51 48951-5076 HUMAN OTC DRUG Hypophysis 7 Special Order Hypophysis 7 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND 7 [hp_X]/1 N 20181231 48951-5077_d135bd08-a29c-448a-8f7b-03d718f8c4e3 48951-5077 HUMAN OTC DRUG Helleborus e pl. tota 3 Special Order Helleborus e pl. tota 3 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HELLEBORUS FOETIDUS ROOT 3 [hp_X]/1 N 20181231 48951-5078_1c9372f4-a8ba-4ad9-9eff-6b2cf3474240 48951-5078 HUMAN OTC DRUG Geum Gentian 1 Special Order Geum Gentian 1 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GENTIANA LUTEA ROOT; GEUM URBANUM ROOT 1; 1 [hp_Q]/1; [hp_Q]/1 N 20181231 48951-5080_8eceefb8-8be5-495c-a8af-9b9f96f5c371 48951-5080 HUMAN OTC DRUG Glandula suprarenales dextra cum cupro Special Order Glandula suprarenales dextra cum cupro Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER; BOS TAURUS ADRENAL GLAND 5; 7 [hp_X]/mL; [hp_X]/mL N 20181231 48951-5082_17b9a8f3-02a6-4a92-a29a-555477fa8ba9 48951-5082 HUMAN OTC DRUG Glandula supr. sinistra Mercurius Special Order Glandula supr. sinistra Mercurius Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; MERCURY 7; 14 [hp_X]/mL; [hp_X]/mL N 20181231 48951-5083_eca34ee6-b99e-48d3-8943-d96ee7566af3 48951-5083 HUMAN OTC DRUG Ginkgo 10 Special Order Ginkgo 10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GINKGO 10 [hp_X]/mL N 20181231 48951-5084_5b8173f3-fe0e-4316-a60f-2fa312b35319 48951-5084 HUMAN OTC DRUG Glandulae suprarenales 30 Special Order Glandulae suprarenales 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND 30 [hp_X]/mL N 20181231 48951-5085_2115c2d3-e891-456e-8d8f-eea5373eb339 48951-5085 HUMAN OTC DRUG Glandula thyreoidea 4 Special Order Glandula thyreoidea 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THYROID, UNSPECIFIED 4 [hp_X]/mL N 20181231 48951-5086_ca3c738f-3520-41c6-a308-23ad91e7545e 48951-5086 HUMAN OTC DRUG HCG 30/15/8 Special Order HCG 30/15/8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GONADOTROPHIN, CHORIONIC 8 1/mL N 20181231 48951-5087_6ed3b032-a307-4799-a457-a0d6d96ce483 48951-5087 HUMAN OTC DRUG Hypophysis Mel Special Order Hypophysis Mel Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PITUITARY GLAND; HONEY 10; 10 [hp_X]/mL; [hp_X]/mL N 20181231 48951-5088_8faf8584-0e3c-48b5-8496-88139f20c320 48951-5088 HUMAN OTC DRUG Glandulae suprarenales 3 Special Order Glandulae suprarenales 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND 3 [hp_X]/mL N 20181231 48951-5089_3d698482-6a00-4304-a2e6-f22af93febaf 48951-5089 HUMAN OTC DRUG Hepar mag. Pulsatilla Tormentilla 6/12/30 Special Order Hepar mag. Pulsatilla Tormentilla 6/12/30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; MAGNESIUM HYDROXIDE; PULSATILLA VULGARIS; POTENTILLA ERECTA ROOT 6; 6; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-5090_799c5ab6-e6db-4ccd-88c0-7a1cc828bd1d 48951-5090 HUMAN OTC DRUG Hypericum 6 Special Order Hypericum 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ST. JOHN'S WORT 6 [hp_X]/1 N 20181231 48951-5091_5d954e8f-d08e-4c4b-8370-a94504ff7a90 48951-5091 HUMAN OTC DRUG Glandulae suprarenales Lien Special Order Glandulae suprarenales Lien Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BILE; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5092_a1e548c9-ba70-4364-9906-c563a7618015 48951-5092 HUMAN OTC DRUG Hepar sulfuris 30 Special Order Hepar sulfuris 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM SULFIDE 30 [hp_X]/mL N 20181231 48951-5093_c35d2507-16ad-4a87-996c-ca4a9551d323 48951-5093 HUMAN OTC DRUG Hypericum ex herba 30 Special Order Hypericum ex herba 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ST. JOHN'S WORT 30 [hp_X]/mL N 20181231 48951-5095_1aaae5e5-41ca-4d50-91de-46ddd7c9ab59 48951-5095 HUMAN OTC DRUG Helleborus Berberis Special Order Helleborus Berberis Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; HELLEBORUS FOETIDUS ROOT; ALUMINUM HYDROXIDE 3; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-5096_7049bc75-de2c-4284-8350-7955919a7a3e 48951-5096 HUMAN OTC DRUG Ginkgo 2 Special Order Ginkgo 2 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GINKGO 2 [hp_X]/mL N 20181231 48951-5097_551224c5-bbbb-00f6-e054-00144ff88e88 48951-5097 HUMAN OTC DRUG Gelsemium Bryonia Gelsemium Bryonia PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc GELSEMIUM SEMPERVIRENS ROOT; BRYONIA CRETICA SUBSP. DIOICA ROOT 3; 3 [hp_X]/1; [hp_X]/1 N 20181231 48951-5098_5513abaa-8831-4bf5-e054-00144ff8d46c 48951-5098 HUMAN OTC DRUG Hypericum Kali Phos. Hypericum Kali Phos. PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc BERBERIS VULGARIS FRUIT; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, UNSPECIFIED FORM 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6000_674a4c13-c8c3-412f-8f0c-294d7bde9baa 48951-6000 HUMAN OTC DRUG Juglans Stannum Special Order Juglans Stannum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. JUGLANS REGIA LEAF; POTASSIUM PHOSPHATE, MONOBASIC; TIN 4; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6003_d33dc7e4-e96c-45c1-ae3d-da6139c4b173 48951-6003 HUMAN OTC DRUG Juniperus Eucalyptus Juniperus Eucalyptus CAPSULE, LIQUID FILLED ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; ACORUS CALAMUS ROOT; CAMPHOR (NATURAL); C12-17 ALKANE; LARIX DECIDUA RESIN; SOLIDAGO CANADENSIS FLOWERING TOP 1; 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6004_579599ad-52c3-4171-e053-2991aa0a9e85 48951-6004 HUMAN OTC DRUG Kalium aceticum comp. 6 Kalium aceticum comp. 6 POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CORALLIUM RUBRUM EXOSKELETON; SAFFRON; POTASSIUM ACETATE; ANTIMONY TRISULFIDE 6; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-6005_e3cafac5-b3cb-4454-8237-c0af3d9bd2e3 48951-6005 HUMAN OTC DRUG Kali Sulf. Bath Essence Kali Sulf. Bath Essence LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. POTASSIUM SULFIDE 1 [hp_X]/mL N 20181231 48951-6006_55c75dc9-1edf-2481-e054-00144ff8d46c 48951-6006 HUMAN OTC DRUG Kalium aceticum comp. 6 Kalium aceticum comp. 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; CORALLIUM RUBRUM EXOSKELETON; SAFFRON; POTASSIUM ACETATE 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6007_2074e9cf-5ac1-478a-8b6d-e8ce3a189057 48951-6007 HUMAN OTC DRUG Kalium carbonicum 10 Kalium carbonicum 10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. POTASSIUM CARBONATE 10 [hp_X]/mL N 20181231 48951-6011_b57bb5dc-79b6-4074-80b6-1ea0b8671c3e 48951-6011 HUMAN OTC DRUG Kali phos. Aurum Kali phos. Aurum TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. POTASSIUM PHOSPHATE, MONOBASIC; GOLD; FERROUS SULFATE; COLLOIDAL SILICON DIOXIDE 6; 10; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6012_55c77d78-d2d2-28bf-e054-00144ff8d46c 48951-6012 HUMAN OTC DRUG Lachesis Belladonna Lachesis Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; MERCURIALIS PERENNIS; CALCIUM SULFIDE; LACHESIS MUTA VENOM 4; 6; 7; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6013_56f41733-85a5-4666-e054-00144ff88e88 48951-6013 HUMAN OTC DRUG Lachesis Belladonna Lachesis Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURIALIS PERENNIS; ATROPA BELLADONNA; CALCIUM SULFIDE; LACHESIS MUTA VENOM 3; 4; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6014_576e9282-5179-6536-e053-2a91aa0a6a4f 48951-6014 HUMAN OTC DRUG Lachesis Belladonna Lachesis Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURIALIS PERENNIS; ATROPA BELLADONNA; CALCIUM SULFIDE; LACHESIS MUTA VENOM 3; 4; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6015_55c7a0dc-a46a-3db1-e054-00144ff88e88 48951-6015 HUMAN OTC DRUG Larynx Bryonia Special Order Larynx Bryonia Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BRYONIA ALBA ROOT; THYROID, BOVINE; LEVISTICUM OFFICINALE ROOT; BOS TAURUS NERVE 20; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6016_576e9282-516b-6536-e053-2a91aa0a6a4f 48951-6016 HUMAN OTC DRUG Larynx Bryonia Larynx Bryonia PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BRYONIA ALBA ROOT; THYROID, BOVINE; LEVISTICUM OFFICINALE ROOT; BOS TAURUS NERVE 20; 20; 20; 20; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6017_55c7a0dc-a476-3db1-e054-00144ff88e88 48951-6017 HUMAN OTC DRUG Larynx Levisticum Special Order Larynx Levisticum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BRYONIA ALBA ROOT; THYROID, BOVINE; LEVISTICUM OFFICINALE ROOT; BOS TAURUS NERVE; BOS TAURUS PARASYMPATHETIC NERVE 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6018_576e0a0c-5f8c-3946-e053-2991aa0a9bab 48951-6018 HUMAN OTC DRUG Larynx Levisticum Larynx Levisticum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; BRYONIA ALBA ROOT; THYROID, BOVINE; LEVISTICUM OFFICINALE ROOT; BOS TAURUS NERVE 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6021_54aed6c0-7ac0-1220-e054-00144ff88e88 48951-6021 HUMAN OTC DRUG Lavender Quartz Ear Oil Lavender Quartz Ear Oil LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ST. JOHN'S WORT; ACONITUM NAPELLUS; ATROPA BELLADONNA; SILICON DIOXIDE; TOXICODENDRON PUBESCENS LEAF; GARLIC; CAMPHOR (NATURAL); LEVISTICUM OFFICINALE ROOT; VERBASCUM DENSIFLORUM LEAF 1; 30; 30; 30; 30; 2; 2; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6023_57d213e3-fdc2-70b1-e053-2991aa0a2e9b 48951-6023 HUMAN OTC DRUG Lemon Quartz Lemon Quartz GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharamcy Inc. SILVER 1 [hp_X]/g N 20181231 48951-6024_cd89eef0-3139-11df-9aae-0800200c9a66 48951-6024 HUMAN OTC DRUG Lemon Quince Allergy Relief LEMON CHINESE QUINCE EXTRACT BERBERIS VULGARIS FRUIT SILICON DIOXIDE SPRAY NASAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc LEMON; CHINESE QUINCE EXTRACT; BERBERIS VULGARIS FRUIT; SILICON DIOXIDE 2; 2; 3; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6026_55c7b55c-b777-3e0d-e054-00144ff88e88 48951-6026 HUMAN OTC DRUG Levico Prunus Levico Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ST. JOHN'S WORT; FERROUS ARSENATE; FERRIC OXIDE RED; PRUNUS SPINOSA FLOWER BUD 3; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6027_576ee529-6ec0-c1bc-e053-2a91aa0a1160 48951-6027 HUMAN OTC DRUG Levico Prunus Levico Prunus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERRIC OXIDE RED; ST. JOHN'S WORT; FERROUS ARSENATE; SLOE 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6028_55c79770-a8ca-358b-e054-00144ff88e88 48951-6028 HUMAN OTC DRUG Levisticum e rad. 3 Levisticum e rad. 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEVISTICUM OFFICINALE ROOT 3 [hp_X]/mL N 20181231 48951-6029_576ee529-6eb4-c1bc-e053-2a91aa0a1160 48951-6029 HUMAN OTC DRUG Levisticum e rad. 3 Levisticum e rad. 3 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEVISTICUM OFFICINALE ROOT 3 [hp_X]/1 N 20181231 48951-6030_57fb353e-cf51-103c-e053-2a91aa0a8c21 48951-6030 HUMAN OTC DRUG Levisticum Quercus Levisticum Quercus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEVISTICUM OFFICINALE ROOT; QUERCUS ROBUR WHOLE; BOS TAURUS EYE; BOS TAURUS NERVE 6; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6031_9dc0c45f-71e1-4e8e-9dca-19102d7e9a65 48951-6031 HUMAN OTC DRUG Levisticum Quercus Special Order Levisticum Quercus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE; LEVISTICUM OFFICINALE ROOT; BOS TAURUS EYE; BOS TAURUS NERVE 6; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6032_576eeff7-5ed9-ca85-e053-2a91aa0a01ae 48951-6032 HUMAN OTC DRUG Levisticum Quercus Levisticum Quercus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE; BOS TAURUS EYE; LEVISTICUM OFFICINALE ROOT 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6033_55c7cbff-0c09-38d4-e054-00144ff8d46c 48951-6033 HUMAN OTC DRUG Lien Cichorium Lien Cichorium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS SPLEEN; PORK KIDNEY; BOS TAURUS CARTILAGE; CICHORIUM INTYBUS WHOLE; EQUISETUM ARVENSE TOP 6; 6; 8; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6034_d05a4765-6155-43a4-9907-3659d92484cf 48951-6034 HUMAN OTC DRUG Lien Cichorium Lien Cichorium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS SPLEEN; PORK KIDNEY; BOS TAURUS CARTILAGE; CICHORIUM INTYBUS WHOLE; EQUISETUM ARVENSE TOP 6; 6; 8; 20; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6035_55c7cbff-0c17-38d4-e054-00144ff8d46c 48951-6035 HUMAN OTC DRUG Lien Plumbum Lien Plumbum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS SPLEEN; LEAD 6; 30 [hp_X]/mL; [hp_X]/mL N 20181231 48951-6036_576ec487-5807-a402-e053-2991aa0a8130 48951-6036 HUMAN OTC DRUG Lien Plumbum Special Order Lien Plumbum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS SPLEEN; LEAD 6; 30 [hp_X]/1; [hp_X]/1 N 20181231 48951-6040_576f4522-4b56-2c03-e053-2a91aa0a8cf9 48951-6040 HUMAN OTC DRUG Lilium Viscum Lilium Viscum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLDENSEAL; LILIUM LANCIFOLIUM WHOLE FLOWERING; VISCUM ALBUM FRUITING TOP; POTASSIUM PHOSPHATE, MONOBASIC; TIN; ALUMINUM OXIDE 3; 3; 3; 6; 8; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6044_55c7d96c-6d0b-44d1-e054-00144ff88e88 48951-6044 HUMAN OTC DRUG Liver comp. Liver comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE; MAMMAL LIVER; MAGNESIUM CATION; TIN 3; 4; 4; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6045_55c7feb4-8fde-40a0-e054-00144ff8d46c 48951-6045 HUMAN OTC DRUG Lobelia Quercus Lobelia Quercus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE; VERONICA OFFICINALIS FLOWERING TOP; LOBELIA SPICATA LEAF; LEAD 4; 4; 6; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6046_56f41733-8575-4666-e054-00144ff88e88 48951-6046 HUMAN OTC DRUG Lobelia Quercus Lobelia Quercus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE; VERONICA OFFICINALIS FLOWERING TOP; LOBELIA SPICATA LEAF; LEAD 4; 4; 6; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6047_576ee529-6ed6-c1bc-e053-2a91aa0a1160 48951-6047 HUMAN OTC DRUG Lobelia Quercus Lobelia Quercus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE; VERONICA OFFICINALIS FLOWERING TOP; LOBELIA SPICATA LEAF; LEAD 4; 4; 6; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6048_55c7feb4-8fec-40a0-e054-00144ff8d46c 48951-6048 HUMAN OTC DRUG Lycopodium Berberis Lycopodium Berberis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS ROOT; TURMERIC; FRAGARIA VESCA WHOLE; LYCOPODIUM CLAVATUM SPORE; VITIS VINIFERA LEAF; SULFIDE ION; CALOMEL 3; 4; 5; 5; 5; 5; 5; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6049_576ec487-5812-a402-e053-2991aa0a8130 48951-6049 HUMAN OTC DRUG Lycopodium Berberis Lycopodium Berberis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE; BERBERIS VULGARIS ROOT BARK; LYCOPODIUM CLAVATUM SPORE; CHELIDONIUM MAJUS ROOT; TURMERIC; FRAGARIA VESCA WHOLE; VITIS VINIFERA LEAF; SULFIDE ION; CALOMEL 1; 3; 3; 5; 5; 5; 5; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6050_55c834d5-2f4e-4020-e054-00144ff8d46c 48951-6050 HUMAN OTC DRUG Lymphocytes 8 Lymphocytes 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUINE THYMOCYTE IMMUNE GLOBULIN 8 [hp_X]/mL N 20181231 48951-6051_56f43092-1098-6a8d-e054-00144ff8d46c 48951-6051 HUMAN OTC DRUG Lysimachia Solanum 5 Lysimachia Solanum 5 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LYSIMACHIA NUMMULARIA; SOLANUM DULCAMARA FLOWER 1; 1 [hp_X]/mL; [hp_X]/mL N 20181231 48951-6052_55c834d5-2f5b-4020-e054-00144ff8d46c 48951-6052 HUMAN OTC DRUG Lysimachia Solanum Special Order Lysimachia Solanum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LYSIMACHIA NUMMULARIA; SOLANUM DULCAMARA FLOWER 1; 1 [hp_X]/mL; [hp_X]/mL N 20181231 48951-6053_576db6ba-c295-ebde-e053-2a91aa0aab51 48951-6053 HUMAN OTC DRUG Hepar Magnesium 6 Special Order Hepar Magnesium 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; MAGNESIUM HYDROXIDE 6; 6 [hp_X]/1; [hp_X]/1 N 20181231 48951-6054_f795ae15-c999-494b-9e43-6d2a4b85b25c 48951-6054 HUMAN OTC DRUG Levisticum comp. Special Order Levisticum comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; APIS MELLIFERA; ATROPA BELLADONNA; MATRICARIA RECUTITA; LEVISTICUM OFFICINALE ROOT; PULSATILLA VULGARIS; THUJA OCCIDENTALIS WHOLE; MERCURY 2; 2; 3; 3; 3; 3; 3; 6; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6055_576f339c-33f3-a975-e053-2991aa0a0849 48951-6055 HUMAN OTC DRUG Liver comp. Special Order Liver comp. Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MILK THISTLE; MAMMAL LIVER; MAGNESIUM HYDROXIDE; TIN 3; 4; 4; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6056_4f957136-b1ec-4065-8c8b-2ba7509a14df 48951-6056 HUMAN OTC DRUG Kali aceticum comp 6 Special Order Kali aceticum comp 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; CORALLIUM RUBRUM EXOSKELETON; SAFFRON; POTASSIUM ACETATE 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-6057_4ba1c57a-6678-4ed1-b85b-5e0206692584 48951-6057 HUMAN OTC DRUG Lemon Quince Special Lemon Quince Special SPRAY NASAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEMON JUICE; QUINCE; BERBERIS VULGARIS ROOT BARK; COLLOIDAL SILICON DIOXIDE 1; 2; 3; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-6058_d0f0787d-8cd3-4a09-8b2c-1117a8a480e6 48951-6058 HUMAN OTC DRUG Lactic acid 6 Special Order Lactic acid 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LACTIC ACID 6 [hp_X]/mL N 20181231 48951-6059_ab58b526-0696-4bf2-ba4e-dbd7265cfed0 48951-6059 HUMAN OTC DRUG Ligamentum long. posterior 8 Special Order Ligamentum long. posterior 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS LIGAMENT 8 [hp_X]/mL N 20181231 48951-6060_b592f41c-3c2a-4bdc-9d2f-86c7779ae5e2 48951-6060 HUMAN OTC DRUG Lymphocytes 30 Special Order Lymphocytes 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUINE THYMOCYTE IMMUNE GLOBULIN 30 [hp_X]/mL N 20181231 48951-6061_55c7feb4-9005-40a0-e054-00144ff8d46c 48951-6061 HUMAN OTC DRUG Lycopodium e pl tota. 8 Special Order Lycopodium e pl tota. 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LYCOPODIUM CLAVATUM SPORE 8 [hp_X]/mL N 20181231 48951-6062_55c7feb4-8ff9-40a0-e054-00144ff8d46c 48951-6062 HUMAN OTC DRUG Lycopodium e pl. tota 3 Special Order Lycopodium e pl. tota 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LYCOPODIUM CLAVATUM SPORE 3 [hp_X]/mL N 20181231 48951-6063_973bde36-b06a-4e01-b443-fda937ceef26 48951-6063 HUMAN OTC DRUG Kalium phosphoricum 6 Special Order Kalium phosphoricum 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. POTASSIUM PHOSPHATE, MONOBASIC 6 [hp_X]/mL N 20181231 48951-6064_da95bfe9-48ee-4b27-9bd3-2213c428cb49 48951-6064 HUMAN OTC DRUG Juglans 14 Special Order Juglans 14 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ENGLISH WALNUT 14 [hp_X]/mL N 20181231 48951-6065_fbd3e47e-1ee0-4e2c-a170-0255b082902e 48951-6065 HUMAN OTC DRUG Lachesis e veneno 30 Special Order Lachesis e veneno 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LACHESIS MUTA VENOM 30 [hp_X]/mL N 20181231 48951-6066_9928a59a-728c-4513-a366-98351f9e256b 48951-6066 HUMAN OTC DRUG Lymphocytes 6 Special Order Lymphocytes 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUINE THYMOCYTE IMMUNE GLOBULIN 6 [hp_X]/mL N 20181231 48951-6067_5855c6bf-1c4d-4910-bd44-409c45fa27ed 48951-6067 HUMAN OTC DRUG Kalium carbonicum 12 Special Order Kalium carbonicum 12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. POTASSIUM CARBONATE 12 [hp_X]/mL N 20181231 48951-6068_54c618e8-7c99-0a1b-e054-00144ff88e88 48951-6068 HUMAN OTC DRUG Lemon Quince Lemon Quince PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc LEMON; CHAENOMELES SINENSIS FRUIT; BERBERIS VULGARIS FRUIT; SILICON DIOXIDE 2; 2; 3; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7000_55da44e6-ded4-35bd-e054-00144ff88e88 48951-7000 HUMAN OTC DRUG Magnesite Viscum Magnesite Viscum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP; APIS MELLIFERA; SUS SCROFA UMBILICAL CORD; BOS TAURUS PITUITARY GLAND; BOS TAURUS MAMMARY GLAND; MAGNESITE 5; 6; 6; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7001_576f7681-ad36-cbb3-e053-2a91aa0a514a 48951-7001 HUMAN OTC DRUG Magnesite Viscum Magnesite Viscum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP; APIS MELLIFERA; SUS SCROFA UMBILICAL CORD; BOS TAURUS PITUITARY GLAND; BOS TAURUS MAMMARY GLAND; MAGNESITE 5; 6; 6; 6; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7002_57959cc6-2da0-4f50-e053-2991aa0a3edd 48951-7002 HUMAN OTC DRUG Magnesium carbonicum 6 Magnesium carbonicum 6 POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM CARBONATE 6 [hp_X]/g N 20181231 48951-7004_576eeff7-5f19-ca85-e053-2a91aa0a01ae 48951-7004 HUMAN OTC DRUG Magnesium sulf. Bryonia Magnesium sulf. Bryonia PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BRYONIA ALBA ROOT; APIS MELLIFERA; VESPA CRABRO; SILICON DIOXIDE; SUS SCROFA UMBILICAL CORD; BOS TAURUS PITUITARY GLAND; MAGNESIUM CATION; BOS TAURUS OVARY; VISCUM ALBUM FRUITING TOP; TIN 3; 3; 5; 5; 6; 6; 6; 6; 6; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7006_55da3fd0-71ec-4666-e054-00144ff8d46c 48951-7006 HUMAN OTC DRUG Magnesium sulf. Bryonia Magnesium sulf. Bryonia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BRYONIA ALBA ROOT; APIS MELLIFERA; VESPA CRABRO; SILICON DIOXIDE; SUS SCROFA UMBILICAL CORD; BOS TAURUS PITUITARY GLAND; MAGNESIUM SULFATE, UNSPECIFIED; BOS TAURUS OVARY; VISCUM ALBUM FRUITING TOP; TIN 3; 3; 5; 5; 6; 6; 6; 6; 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7009_55da7020-9753-4ecc-e054-00144ff8d46c 48951-7009 HUMAN OTC DRUG Mamma (dextra) 6 Mamma (dextra) 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS MAMMARY GLAND 6 [hp_X]/mL N 20181231 48951-7010_55da7a69-e9ac-4ff1-e054-00144ff8d46c 48951-7010 HUMAN OTC DRUG Mamma (sinistra) 6 Mamma (sinistra) 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS MAMMARY GLAND 6 [hp_X]/mL N 20181231 48951-7012_55da9353-8716-3f5d-e054-00144ff88e88 48951-7012 HUMAN OTC DRUG Mandragora Arnica Mandragora Arnica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA MENISCUS; FORMICA RUFA; ARNICA MONTANA; EQUISETUM ARVENSE TOP 3; 3; 6; 10; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7013_e92bf64b-39cc-47cc-b903-c0258f15964c 48951-7013 HUMAN OTC DRUG Mandragora e rad. 2 Mandragora e rad. 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MANDRAGORA OFFICINARUM ROOT 2 [hp_X]/mL N 20181231 48951-7014_bc3ff308-da05-4507-9ed0-c73bc4884027 48951-7014 HUMAN OTC DRUG Mandragora e rad. 3 Mandragora e rad. 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MANDRAGORA OFFICINARUM ROOT 3 [hp_X]/mL N 20181231 48951-7015_55da86a9-10b5-5203-e054-00144ff8d46c 48951-7015 HUMAN OTC DRUG Mandragora Rheum Mandragora Rheum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MANDRAGORA OFFICINARUM ROOT; TARAXACUM PALUSTRE ROOT; SILVER; BOVINE TYPE I COLLAGEN; FORMICA RUFA; SUS SCROFA PANCREAS; BOS TAURUS BONE 3; 3; 6; 6; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7016_576f339c-340e-a975-e053-2991aa0a0849 48951-7016 HUMAN OTC DRUG Mandragora Rheum Mandragora Rheum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MANDRAGORA OFFICINARUM ROOT; TARAXACUM PALUSTRE ROOT; SILVER; BOVINE TYPE I COLLAGEN; FORMICA RUFA; SUS SCROFA PANCREAS; BOS TAURUS BONE 3; 3; 6; 6; 6; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7018_be60f6bc-a05d-4189-85ab-f2a2dcfc8640 48951-7018 HUMAN OTC DRUG Marjoram Melissa Adult Size Marjoram Melissa Adult Size SUPPOSITORY VAGINAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SWEET MARJORAM; MELISSA OFFICINALIS 1; 1 [hp_X]/g; [hp_X]/g N 20181231 48951-7021_55da86a9-10c1-5203-e054-00144ff8d46c 48951-7021 HUMAN OTC DRUG Medulla Arnica Medulla Arnica LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CERVUS ELAPHUS WHOLE; BOS TAURUS SPINAL CORD; ANTIMONY; GOLD; BETULA PUBESCENS BARK; SILICON DIOXIDE; ARNICA MONTANA 8; 8; 8; 10; 10; 17; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7022_576f7681-ad28-cbb3-e053-2a91aa0a514a 48951-7022 HUMAN OTC DRUG Medulla Arnica Medulla Arnica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CERVUS ELAPHUS WHOLE; BOS TAURUS SPINAL CORD; ANTIMONY; GOLD; BETULA PUBESCENS BARK; SILICON DIOXIDE; ARNICA MONTANA 8; 8; 8; 10; 10; 17; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7023_55dac11c-a7ad-5a71-e054-00144ff8d46c 48951-7023 HUMAN OTC DRUG Medulla ossium 8 Medulla ossium 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE MARROW 8 [hp_X]/mL N 20181231 48951-7027_cc7aba4e-d6c7-41d4-97bf-8507f19dc1d4 48951-7027 HUMAN OTC DRUG Melissa Chamomilla Melissa Chamomilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; MATRICARIA RECUTITA; MELISSA OFFICINALIS; SEPIA OFFICINALIS JUICE; ACONITUM NAPELLUS; LACHESIS MUTA VENOM 3; 3; 3; 6; 10; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7028_3c550202-4f1d-4194-9635-64b67f5e00b8 48951-7028 HUMAN OTC DRUG Melissa Chamomilla Special Order Melissa Chamomilla Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; MATRICARIA RECUTITA; MELISSA OFFICINALIS; SEPIA OFFICINALIS JUICE; ACONITUM NAPELLUS; LACHESIS MUTA VENOM 1; 1; 1; 4; 8; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-7035_5a36dee7-d855-4ff2-80ac-21949055fcd9 48951-7035 HUMAN OTC DRUG Meniscus 6 Meniscus 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA MENISCUS 6 [hp_X]/mL N 20181231 48951-7036_57fb2f25-d610-85be-e053-2991aa0a8ad5 48951-7036 HUMAN OTC DRUG Mercurialis 3 Mercurialis 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURIALIS PERENNIS 3 [hp_X]/mL N 20181231 48951-7038_1c54ad3e-398a-4551-bb84-2d4fa905c268 48951-7038 HUMAN OTC DRUG Mercurius auratus 15 Special Order Mercurius auratus 15 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 15 [hp_X]/mL N 20181231 48951-7039_914c098e-9383-4763-8bb1-9824d7193473 48951-7039 HUMAN OTC DRUG Mercurius auratus 15 Special Order Mercurius auratus 15 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 15 [hp_X]/mL N 20181231 48951-7040_55dae099-0005-4b76-e054-00144ff88e88 48951-7040 HUMAN OTC DRUG Mercurius auratus Pulmo Mercurius auratus Pulmo LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA LUNG; MERCURY 6; 15 [hp_X]/mL; [hp_X]/mL N 20181231 48951-7042_56f5220e-e799-61e8-e054-00144ff88e88 48951-7042 HUMAN OTC DRUG Mercurius cyanatus 6 Mercurius cyanatus 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURIC CYANIDE 6 [hp_X]/mL N 20181231 48951-7043_54d013d6-ab8b-4b6b-b2bd-757f07ab37c2 48951-7043 HUMAN OTC DRUG Mercurius Nasturtium Special Order Mercurius Nasturtium Special Order TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TROPAEOLUM MAJUS; MERCURY; TIN 2; 5; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7044_55daff90-9413-63a0-e054-00144ff8d46c 48951-7044 HUMAN OTC DRUG Mercurius vivus 8 Mercurius vivus 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 8 [hp_X]/mL N 20181231 48951-7046_55db0b56-f28b-66e2-e054-00144ff8d46c 48951-7046 HUMAN OTC DRUG Mesenchyme Quercus Mesenchyme Quercus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; MAMMAL LIVER; SUS SCROFA PANCREAS; SUS SCROFA LUNG; QUERCUS ROBUR WHOLE; PORK KIDNEY; BOS TAURUS CARTILAGE 6; 6; 6; 6; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7047_57976239-91bc-9e21-e053-2991aa0a2a13 48951-7047 HUMAN OTC DRUG Mesenchyme Quercus Mesenchyme Quercus CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; MAMMAL LIVER; SUS SCROFA PANCREAS; SUS SCROFA LUNG; QUERCUS ROBUR WHOLE; PORK KIDNEY; BOS TAURUS CARTILAGE 8; 8; 8; 8; 8; 8; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-7048_576ec487-582e-a402-e053-2991aa0a8130 48951-7048 HUMAN OTC DRUG Mesenchyme Quercus Mesenchyme Quercus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; MAMMAL LIVER; SUS SCROFA PANCREAS; SUS SCROFA LUNG; QUERCUS ROBUR WHOLE; PORK KIDNEY; BOS TAURUS CARTILAGE 6; 6; 6; 6; 6; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7050_e1ad0035-5be7-4f50-af3c-465f3b22a392 48951-7050 HUMAN OTC DRUG Meteoric iron Phos Quartz Meteoric iron Phos Quartz PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS; IRON; COLLOIDAL SILICON DIOXIDE 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7051_55db3799-28e4-6c64-e054-00144ff8d46c 48951-7051 HUMAN OTC DRUG Meteoric Iron Phosphorus Quartz Meteoric Iron Phosphorus Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS; IRON; SILICON DIOXIDE 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7052_55db3959-8662-5664-e054-00144ff88e88 48951-7052 HUMAN OTC DRUG Meteoric Iron Prunus Meteoric Iron Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE; ECHINACEA, UNSPECIFIED; PHOSPHORUS; IRON; SILICON DIOXIDE 2; 3; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7053_e97b28cb-3052-4cb1-92e8-7673469d1906 48951-7053 HUMAN OTC DRUG Meteoric Iron Prunus Immune Support PRUNUS SPINOSA ECHINACEA PALLIDA PHOSPHORUS SILICON DIOXIDE IRON PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc PRUNUS SPINOSA FLOWER BUD; ECHINACEA PALLIDA; PHOSPHORUS; SILICON DIOXIDE; IRON 2; 3; 6; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7054_56f43092-108a-6a8d-e054-00144ff8d46c 48951-7054 HUMAN OTC DRUG Meteoric Iron Prunus Meteoric Iron Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE; ECHINACEA, UNSPECIFIED; PHOSPHORUS; IRON; SILICON DIOXIDE 2; 3; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7055_576fc260-277d-5376-e053-2991aa0ac317 48951-7055 HUMAN OTC DRUG Mezereum Comp. Mezereum Comp. PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; LYTTA VESICATORIA; CROTON TIGLIUM WHOLE; DAPHNE MEZEREUM WHOLE; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7057_7c95d552-02de-4971-b32b-9e0ba1a76749 48951-7057 HUMAN OTC DRUG Minimum Formica Special Order Minimum Formica Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FORMICA RUFA; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; FUCUS VESICULOSUS; THYROID, UNSPECIFIED; BOS TAURUS PINEAL GLAND; PENOXSULAM 6; 6; 6; 6; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7058_55dc055c-f610-1774-e054-00144ff8d46c 48951-7058 HUMAN OTC DRUG Musculus deltoides comp. 12 Special Order Musculus deltoides comp. 12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 12 [hp_X]/mL N 20181231 48951-7061_56f50eda-538c-1bfe-e054-00144ff8d46c 48951-7061 HUMAN OTC DRUG Mygale Agaricus Mygale Agaricus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DATURA STRAMONIUM; AMANITA MUSCARIA FRUITING BODY; AVICULARIA AVICULARIA 3; 4; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7062_55dc055c-f620-1774-e054-00144ff8d46c 48951-7062 HUMAN OTC DRUG Myristica Argentum Myristica Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VIROLA SEBIFERA RESIN; DICHROMATE ION; BOS TAURUS NASAL MUCOSA; SILVER 4; 6; 7; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7063_285c67a0-05dd-11df-8a39-0800200c9a66 48951-7063 HUMAN OTC DRUG Myristica Argentum Sinus Relief POTASSIUM DICHROMATE SUS SCROFA NASAL MUCOSA SILVER NITRATE PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc POTASSIUM DICHROMATE; SUS SCROFA NASAL MUCOSA; SILVER NITRATE 6; 7; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7064_c4f583ca-9e97-4683-876e-d989f78ec133 48951-7064 HUMAN OTC DRUG Naja e veneno 10 Naja e veneno 10 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. NAJA NAJA VENOM 10 [hp_X]/mL N 20181231 48951-7066_7afcc3a7-9f64-46f3-82e4-8bb793df4d82 48951-7066 HUMAN OTC DRUG Nervus ischiadicus 6 Special Order Nervus ischiadicus 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NERVE 6 [hp_X]/mL N 20181231 48951-7068_def9cdb6-fc8c-43ae-a516-3adb244f4179 48951-7068 HUMAN OTC DRUG Nervus peronaeus 30 Special Order Nervus peronaeus 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NERVE 30 [hp_X]/mL N 20181231 48951-7069_4923a294-a37f-4eb7-94b0-ce70091562b3 48951-7069 HUMAN OTC DRUG Nervus trigeminus 30 Special Order Nervus trigeminus 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NERVE 30 [hp_X]/mL N 20181231 48951-7071_55dc8e66-02cf-0ede-e054-00144ff88e88 48951-7071 HUMAN OTC DRUG Nicotiana Carbo Nicotiana Carbo LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA; LOBELIA SPICATA LEAF; TOBACCO LEAF; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL 3; 6; 10; 12; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7072_576fbf45-62f2-351a-e053-2991aa0af5ab 48951-7072 HUMAN OTC DRUG Nicotiana Carbo Nicotiana Carbo PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA; LOBELIA SPICATA LEAF; TOBACCO LEAF; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL 3; 6; 10; 12; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7074_55dc93ad-c542-234f-e054-00144ff8d46c 48951-7074 HUMAN OTC DRUG Nicotiana e fol. 6 Nicotiana e fol. 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TOBACCO LEAF 6 [hp_X]/mL N 20181231 48951-7075_5d69ae64-b2b3-4559-81d8-745b70c7aea8 48951-7075 HUMAN OTC DRUG Nicotiana Pulsatilla Special Order Nicotiana Pulsatilla Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; PULSATILLA VULGARIS; TOBACCO LEAF 3; 4; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7076_576fc260-27c3-5376-e053-2991aa0ac317 48951-7076 HUMAN OTC DRUG Nicotiana Pulsatilla Nicotiana Pulsatilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; PULSATILLA VULGARIS; TOBACCO LEAF 3; 4; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7077_4f00c342-7914-4d0e-84cd-aec9515faf55 48951-7077 HUMAN OTC DRUG Nodi Lymphatici 8 Nodi Lymphatici 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS LYMPH VESSEL 8 [hp_X]/mL N 20181231 48951-7079_576fd03b-4edb-b41d-e053-2a91aa0a0da2 48951-7079 HUMAN OTC DRUG Nux vomica e sem. 3 Nux vomica e sem. 3 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STRYCHNOS NUX-VOMICA SEED 3 [hp_X]/1 N 20181231 48951-7080_55dcc526-05b7-352e-e054-00144ff8d46c 48951-7080 HUMAN OTC DRUG Nux vomica Chamomilla Nux vomica Chamomilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA; ROBINIA PSEUDOACACIA BARK; PORK KIDNEY; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; ACTIVATED CHARCOAL 3; 6; 7; 8; 10; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7081_576fc260-27b0-5376-e053-2991aa0ac317 48951-7081 HUMAN OTC DRUG Nux vomica Chamomilla Nux vomica Chamomilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT; ROBINIA PSEUDOACACIA BARK; PORK KIDNEY; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; ACTIVATED CHARCOAL 3; 6; 7; 8; 10; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7083_b6e3e76b-d817-4dcc-b441-a1dd682448fe 48951-7083 HUMAN OTC DRUG Olivenite 17 Special Order Olivenite 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC ARSENITE 17 [hp_X]/mL N 20181231 48951-7084_549b24fe-1488-24a4-e054-00144ff88e88 48951-7084 HUMAN OTC DRUG Olivenite 6 Special Order Olivenite 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER ARSENATE 6 [hp_X]/mL N 20181231 48951-7086_2a9a38f4-326c-4eec-9468-934024232c25 48951-7086 HUMAN OTC DRUG Olivenite Stannum Special Order Olivenite Stannum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. JACOBAEA VULGARIS; SPINACIA OLERACEA ROOT; COPPER ARSENATE; PULSATILLA VULGARIS; FERROSOFERRIC PHOSPHATE; TIN 3; 3; 6; 6; 7; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7087_576fc260-27a1-5376-e053-2991aa0ac317 48951-7087 HUMAN OTC DRUG Olivenite Stannum Olivenite Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. JACOBAEA VULGARIS; SPINACIA OLERACEA ROOT; CUPRIC ARSENATE; PULSATILLA VULGARIS; FERROSOFERRIC PHOSPHATE; TIN 3; 3; 6; 6; 7; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7088_56f43092-107f-6a8d-e054-00144ff8d46c 48951-7088 HUMAN OTC DRUG Onopordon Aurum Onopordon Aurum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GOLD; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF 10; 1; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7089_56f43092-1071-6a8d-e054-00144ff8d46c 48951-7089 HUMAN OTC DRUG Onopordon comp. Onopordon comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF 1; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7090_577106d0-02bc-4be3-e053-2991aa0a1a0a 48951-7090 HUMAN OTC DRUG Onopordon comp. Onopordon comp. PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF 1; 1; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7092_55dcd063-567f-35aa-e054-00144ff8d46c 48951-7092 HUMAN OTC DRUG Onopordon Comp. Onopordon Comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF 1; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7093_55dcc526-05c5-352e-e054-00144ff8d46c 48951-7093 HUMAN OTC DRUG Onopordon comp. mite Onopordon comp. mite LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF 1; 1; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7094_55dcc526-05d7-352e-e054-00144ff8d46c 48951-7094 HUMAN OTC DRUG Organoplex Organoplex LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; MAMMAL LIVER; SUS SCROFA LUNG; PORK KIDNEY 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7095_577106d0-029e-4be3-e053-2991aa0a1a0a 48951-7095 HUMAN OTC DRUG Organoplex Organoplex PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; MAMMAL LIVER; SUS SCROFA LUNG; PORK KIDNEY 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7096_009d1de0-2bc6-11df-8a39-0800200c9a66 48951-7096 HUMAN OTC DRUG Osteodoron AM Bone Support PUMPKIN SILICON DIOXIDE CALCIUM FLUORIDE FLUORAPATITE POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc PUMPKIN; SILICON DIOXIDE; CALCIUM FLUORIDE; FLUORAPATITE 3; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7097_ff723fd0-2df1-11df-8a39-0800200c9a66 48951-7097 HUMAN OTC DRUG Osteodoron PM Bone Support OYSTER SHELL CALCIUM CARBONATE, CRUDE WHITE OAK BARK CALCIUM FLUORIDE SILICON DIOXIDE POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc OYSTER SHELL CALCIUM CARBONATE, CRUDE; WHITE OAK BARK; CALCIUM FLUORIDE; SILICON DIOXIDE 1; 4; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7098_55de4016-e494-4db7-e054-00144ff88e88 48951-7098 HUMAN OTC DRUG Ovaria Apis Special Order Ovaria Apis Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROYAL JELLY; SILVER; BOS TAURUS OVARY 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7099_577106d0-0290-4be3-e053-2991aa0a1a0a 48951-7099 HUMAN OTC DRUG Ovaria Apis Ovaria Apis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROYAL JELLY; SILVER; BOS TAURUS OVARY 6; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7100_29457538-f360-49a1-8f23-89c9f0e69887 48951-7100 HUMAN OTC DRUG Ovarium 6 Special Order Ovarium 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS OVARY 6 [hp_X]/mL N 20181231 48951-7102_47cfeba8-d2b4-45e4-b9e3-9d0a9a4bd249 48951-7102 HUMAN OTC DRUG Oxalis 10 Oxalis 10 GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS MONTANA LEAF 1 [hp_X]/g N 20181231 48951-7103_e207f5a2-25a4-47c7-bda9-28838afd4fa9 48951-7103 HUMAN OTC DRUG Oxalis 20 Oxalis 20 GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS MONTANA LEAF 1 [hp_X]/g N 20181231 48951-7106_57974c81-7483-682e-e053-2a91aa0a84b1 48951-7106 HUMAN OTC DRUG Oxalis 5 Oxalis 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS ACETOSELLA LEAF 5 [hp_X]/g N 20181231 48951-7108_56f5a172-d3a5-735c-e054-00144ff88e88 48951-7108 HUMAN OTC DRUG Oxalis Belladonna Oxalis Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; MATRICARIA RECUTITA; GELSEMIUM SEMPERVIRENS ROOT; OXALIS ACETOSELLA LEAF; SANGUINARIA CANADENSIS ROOT 4; 4; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7109_b8ae6ff2-f300-4240-9515-539528d818b9 48951-7109 HUMAN OTC DRUG Oxalis e pl. tota 3 Oxalis e pl. tota 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS MONTANA LEAF 3 [hp_X]/mL N 20181231 48951-7112_55dbf40a-9271-6b93-e054-00144ff88e88 48951-7112 HUMAN OTC DRUG Opal 30 Opal 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HYDRATED SILICA 30 [hp_X]/mL N 20181231 48951-7113_576f4522-4b73-2c03-e053-2a91aa0a8cf9 48951-7113 HUMAN OTC DRUG Medulla Ossium 8 Special Order Medulla Ossium 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE MARROW 8 [hp_X]/1 N 20181231 48951-7114_20febe31-e741-461a-8816-5f01f3a211c7 48951-7114 HUMAN OTC DRUG Magnesium sulf Conchae Special Order Magnesium sulf Conchae Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS BARK; URTICA URENS; MAGNESIUM SULFATE; OSTREA EDULIS SHELL; FORMICA RUFA; COLLOIDAL SILICON DIOXIDE 2; 3; 6; 10; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7115_5795a22d-81cc-028a-e053-2a91aa0a8bec 48951-7115 HUMAN OTC DRUG Osteodoron AM Special Formula Osteodoron AM Special Formula POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUCURBITA PEPO FLOWER; FLUORAPATITE; CALCIUM FLUORIDE; SILICON DIOXIDE; LEAD CARBONATE 3; 6; 6; 6; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-7116_577106d0-02d0-4be3-e053-2991aa0a1a0a 48951-7116 HUMAN OTC DRUG Onopordon Aurum Special Order Onopordon Aurum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; GOLD 3; 3; 5; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7117_ce1344e1-8c89-462b-a927-af3eb0d8271a 48951-7117 HUMAN OTC DRUG Musculus deltoideus comp. 8 Special Order Musculus deltoideus comp. 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 8 [hp_X]/1 N 20181231 48951-7119_56f4b751-4247-571e-e054-00144ff88e88 48951-7119 HUMAN OTC DRUG Organoplex Special Order Organoplex Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART; MAMMAL LIVER; SUS SCROFA LUNG; PORK KIDNEY 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7120_55dae099-0020-4b76-e054-00144ff88e88 48951-7120 HUMAN OTC DRUG Mercurius vivus 10/20/30 Special Order Mercurius vivus 10/20/30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 10 [hp_X]/mL N 20181231 48951-7121_9e7d509f-2035-41d7-a1fc-95f5c005cc80 48951-7121 HUMAN OTC DRUG Nervus facialis comp. Special Order Nervus facialis comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PARASYMPATHETIC NERVE; APIS MELLIFERA; SILVER; ARNICA MONTANA; FORMICA RUFA; ST. JOHN'S WORT 8; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7122_55c834d5-2f68-4020-e054-00144ff8d46c 48951-7122 HUMAN OTC DRUG Magnesium phosphoricum 6 Special Order Magnesium phosphoricum 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE 6 [hp_X]/mL N 20181231 48951-7123_5c084296-f874-4a51-81a9-8fb389e32699 48951-7123 HUMAN OTC DRUG Mercurius solubilis 12 Special Order Mercurius solubilis 12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURIUS SOLUBILIS 12 [hp_X]/mL N 20181231 48951-7124_0726160c-5785-4533-80e0-964f0c2dc76e 48951-7124 HUMAN OTC DRUG Musculus deltoideus 8 Special Order Musculus deltoideus 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 8 [hp_X]/mL N 20181231 48951-7125_55dc40db-0c82-04ff-e054-00144ff88e88 48951-7125 HUMAN OTC DRUG Nervus Vagus 6 Special Order Nervus Vagus 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PARASYMPATHETIC NERVE 6 [hp_X]/mL N 20181231 48951-7126_e47cbdea-c17a-4d7f-83a2-163368aae0c3 48951-7126 HUMAN OTC DRUG Nervus pudendus 8 Special Order Nervus pudendus 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS SOMATIC NERVE 8 [hp_X]/mL N 20181231 48951-7127_71657854-9a6f-45b6-afbc-783c3ab61569 48951-7127 HUMAN OTC DRUG Mercurialis Calendula Prunus Special Order Mercurialis Calendula Prunus Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; MERCURIALIS PERENNIS; SLOE 2; 2; 2; 2; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-7128_15c22c9e-200c-4c3c-afd3-3a1743e5d867 48951-7128 HUMAN OTC DRUG Mandragora 5% Special Order Mandragora 5% Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MANDRAGORA OFFICINARUM ROOT 1 [hp_X]/g N 20181231 48951-7129_34aad93b-d596-4c60-85f1-abc40d553f75 48951-7129 HUMAN OTC DRUG Mercurius vivus 5 Special Order Mercurius vivus 5 Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 5 [hp_X]/g N 20181231 48951-7130_09033082-ae6d-4683-a581-b58a690bdc18 48951-7130 HUMAN OTC DRUG Minium Formica Special Order Minium Formica Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OXALIS MONTANA LEAF; KALANCHOE DAIGREMONTIANA LEAF; ROSMARINUS OFFICINALIS FLOWERING TOP; ARSENIC TRIOXIDE; LEAD TETROXIDE; FORMICA RUFA; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; FUCUS VESICULOSUS; THYROID, UNSPECIFIED; BOS TAURUS PINEAL GLAND; PENOXSULAM 2; 2; 4; 6; 6; 6; 6; 6; 6; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7132_9eaf5ea9-30f7-4dfd-a5ce-8b462e427d2b 48951-7132 HUMAN OTC DRUG Mercurialis 10 Special Order Mercurialis 10 Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURIALIS PERENNIS 1 [hp_X]/g N 20181231 48951-7133_11264e8b-7c0c-486c-a240-ee81bc64c706 48951-7133 HUMAN OTC DRUG Myristica Levisticum comp Special Order Myristica Levisticum comp Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEVISTICUM OFFICINALE ROOT; VIROLA SEBIFERA RESIN; POTASSIUM DICHROMATE; BOS TAURUS NASAL MUCOSA; SILVER 3; 4; 6; 7; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-7134_55dcd063-5665-35aa-e054-00144ff8d46c 48951-7134 HUMAN OTC DRUG Nux vomica e sem. 6 Special Order Nux vomica e sem. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STRYCHNOS NUX-VOMICA SEED 6 [hp_X]/mL N 20181231 48951-7135_55ba7592-ffcd-44cf-87a4-2c3f5c32375a 48951-7135 HUMAN OTC DRUG Onyx 6 Special Order Onyx 6 Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BIFENTHRIN 6 [hp_X]/g N 20181231 48951-7136_78d8ccb3-cce6-4afd-8b8b-70ddc078b2ef 48951-7136 HUMAN OTC DRUG Mercurius 10/20/30 Special Order Mercurius 10/20/30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 10 [hp_X]/mL N 20181231 48951-7137_735faa31-aa09-4a2b-b2d0-da53506c22a2 48951-7137 HUMAN OTC DRUG Mercurius auratus Pulmo Special Order Mercurius auratus Pulmo Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA LUNG; MERCURY 6; 15 [hp_X]/mL; [hp_X]/mL N 20181231 48951-7140_006f75dc-e2ff-4b51-b4f3-d5ec56f0221b 48951-7140 HUMAN OTC DRUG Mandragora 10 Special Order Mandragora 10 Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MANDRAGORA OFFICINARUM ROOT 1 [hp_X]/g N 20181231 48951-7141_4bf32eb9-d210-4bf7-aedd-0e47edb64fdc 48951-7141 HUMAN OTC DRUG Mercurius vivus 10/20/30 Special Order Mercurius vivus 10/20/30 Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURY 10 [hp_X]/g N 20181231 48951-7142_ed11eaef-29c9-4aec-8e35-e2159ceefc9f 48951-7142 HUMAN OTC DRUG Mercurius cyanatus 8 Mercurius cyanatus 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURIC CYANIDE 8 [hp_X]/mL N 20181231 48951-7143_0614d477-aaab-41d7-ba0b-0c4e2891390d 48951-7143 HUMAN OTC DRUG Meniscus 6 Special Order Meniscus 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA MENISCUS 6 [hp_X]/1 N 20181231 48951-7144_0305bbce-a0a8-46a9-82cf-45872921ff45 48951-7144 HUMAN OTC DRUG Myristica Argentum Special Order Myristica Argentum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VIROLA SEBIFERA RESIN; DICHROMATE ION; BOS TAURUS NASAL MUCOSA; SILVER 4; 6; 7; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7146_f3af3dc3-0bbf-4ae6-9db5-7a718ff0d615 48951-7146 HUMAN OTC DRUG Lien Plumbum Special Order Lien Plumbum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS SPLEEN; LEAD 6; 30 [hp_X]/mL; [hp_X]/mL N 20181231 48951-7147_54ac5a58-2760-366a-e054-00144ff88e88 48951-7147 HUMAN OTC DRUG Melissa Melissa GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MELISSA OFFICINALIS 1 [hp_X]/g N 20181231 48951-7150_549b24fe-1493-24a4-e054-00144ff88e88 48951-7150 HUMAN OTC DRUG Oxalis Belladonna Special Order Oxalis Belladonna Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; CHELIDONIUM MAJUS ROOT; GELSEMIUM SEMPERVIRENS ROOT; OXALIS STRICTA WHOLE; SANGUINARIA CANADENSIS ROOT 4; 4; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-7151_54c23582-f001-3d9d-e054-00144ff8d46c 48951-7151 HUMAN OTC DRUG Mercurialis Calendula Healing Mercurialis Calendula Healing OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MERCURIALIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ONION 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-7152_54c653b7-2e58-19e3-e054-00144ff88e88 48951-7152 HUMAN OTC DRUG Melissa Chamomilla Melissa Chamomilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc MATRICARIA RECUTITA; MELISSA OFFICINALIS; ACONITUM NAPELLUS ROOT; LACHESIS MUTA VENOM 3; 3; 10; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8000_55de30f8-b944-6207-e054-00144ff8d46c 48951-8000 HUMAN OTC DRUG Pancreas Argentum Pancreas Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA; SUS SCROFA PANCREAS; SILVER 3; 20; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8001_5770fcc8-5902-9c37-e053-2a91aa0a9f01 48951-8001 HUMAN OTC DRUG Pancreas Argentum Pancreas Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; SUS SCROFA PANCREAS; SILVER 3; 17; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8002_55deaed0-9482-0aaf-e054-00144ff8d46c 48951-8002 HUMAN OTC DRUG Pancreas Equisetum Pancreas Equisetum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA PANCREAS; QUERCUS ROBUR WHOLE; EQUISETUM ARVENSE TOP 5; 5; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8003_57713e5f-f538-954f-e053-2991aa0a82a7 48951-8003 HUMAN OTC DRUG Pancreas Equisetum Pancreas Equisetum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; SUS SCROFA PANCREAS; QUERCUS ROBUR WHOLE 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8004_55deaed0-94bd-0aaf-e054-00144ff8d46c 48951-8004 HUMAN OTC DRUG Pancreas Meteoric Iron Pancreas Meteoric Iron LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROSMARINUS OFFICINALIS FLOWERING TOP; SUS SCROFA PANCREAS; IRON 4; 6; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8005_56f5a172-d396-735c-e054-00144ff88e88 48951-8005 HUMAN OTC DRUG Pancreas Meteoric Iron Pancreas Meteoric Iron LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROSMARINUS OFFICINALIS FLOWERING TOP; SUS SCROFA PANCREAS; IRON 4; 6; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8006_55de7d41-2231-6faa-e054-00144ff8d46c 48951-8006 HUMAN OTC DRUG Pandanus Calc. carb. Pandanus Calc. carb. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM CARBONATE; PANDANUS TECTORIUS ROOT 6; 6 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8007_57718ee8-c2ad-60e0-e053-2a91aa0a8271 48951-8007 HUMAN OTC DRUG Pandanus Calc. Carb Pandanus Calc. Carb PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALCIUM CARBONATE; PANDANUS TECTORIUS ROOT 1; 6 [hp_X]/1; [hp_X]/1 N 20181231 48951-8008_406e2a06-3494-4e1c-8384-dc2b6dc962dc 48951-8008 HUMAN OTC DRUG Parathyreoidea Aurum Special Order Parathyreoidea Aurum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE; BOS TAURUS PARATHYROID GLAND; GOLD 6; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8009_c5d118bf-6151-4952-bdd7-c0c6479dc97b 48951-8009 HUMAN OTC DRUG Parathyreoidea Aurum Special Order Parathyreoidea Aurum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE; BOS TAURUS PARATHYROID GLAND; GOLD 6; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8011_55decb3d-617e-613a-e054-00144ff88e88 48951-8011 HUMAN OTC DRUG Passiflora Crataegus Passiflora Crataegus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; HAWTHORN LEAF WITH FLOWER; PASSIFLORA INCARNATA FLOWERING TOP; SALIX ALBA FLOWER 2; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8012_57713e5f-f52a-954f-e053-2991aa0a82a7 48951-8012 HUMAN OTC DRUG Passiflora Crataegus Passiflora Crataegus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; HAWTHORN LEAF WITH FLOWER; PASSIFLORA INCARNATA FLOWERING TOP; SALIX ALBA FLOWER 2; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8013_e3770cf5-37cc-441d-9394-8370bda7c498 48951-8013 HUMAN OTC DRUG Passiflora ex herba 1 Special Order Passiflora ex herba 1 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X]/mL N 20181231 48951-8016_55dec89e-05bf-5f55-e054-00144ff88e88 48951-8016 HUMAN OTC DRUG Periodontium Hypophysis Periodontium Hypophysis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF TONGUE; BOS TAURUS PITUITARY GLAND; BOS TAURUS BONE; SUS SCROFA TOOTH; TIN 8; 8; 8; 8; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8017_55dee711-0cbb-1080-e054-00144ff8d46c 48951-8017 HUMAN OTC DRUG Periodontium Quartz Periodontium Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP; ATROPA BELLADONNA; BEEF TONGUE; BOS TAURUS BONE; SUS SCROFA TOOTH; SILVER; SILICON DIOXIDE 3; 17; 17; 17; 17; 20; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8018_fa650229-6e71-4391-9663-8d93d06d6f6b 48951-8018 HUMAN OTC DRUG Petasites e rad. 1 Special Order Petasites e rad. 1 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PETASITES HYBRIDUS ROOT 1 [hp_X]/mL N 20181231 48951-8019_4ec3e3b2-930b-4af4-a9d7-357871b057d1 48951-8019 HUMAN OTC DRUG Petasites Plantago Special Order Petasites Plantago Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ABIES ALBA LEAFY TWIG; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF; FERROSOFERRIC PHOSPHATE; SUS SCROFA LUNG 3; 3; 3; 8; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8020_577155d7-4a59-b4d4-e053-2991aa0adee1 48951-8020 HUMAN OTC DRUG Petasites Plantago Petasites Plantago PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ABIES ALBA LEAFY TWIG; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF; FERROSOFERRIC PHOSPHATE; SUS SCROFA LUNG 3; 3; 3; 8; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8021_5771d032-ffbd-50f7-e053-2991aa0a98f4 48951-8021 HUMAN OTC DRUG Petasites Quercus Petasites Quercus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ABIES ALBA LEAFY TWIG; PETASITES HYBRIDUS ROOT; QUERCUS ROBUR WHOLE; PLANTAGO MAJOR 3; 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8022_57711166-1eea-3c0e-e053-2a91aa0a65e0 48951-8022 HUMAN OTC DRUG Petasites Veronica Petasites Veronica PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ABIES ALBA LEAFY TWIG; PETASITES HYBRIDUS ROOT; VERONICA OFFICINALIS FLOWERING TOP; PLANTAGO MAJOR LEAF 3; 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8023_55df1359-3bce-20bf-e054-00144ff8d46c 48951-8023 HUMAN OTC DRUG Phosphorus 30 Phosphorus 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS 30 [hp_X]/mL N 20181231 48951-8024_09741445-2d0d-459e-83af-dc6707306adb 48951-8024 HUMAN OTC DRUG Phosphorus 30 Special Order Phosphorus 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS 30 [hp_X]/mL N 20181231 48951-8025_57711166-1edd-3c0e-e053-2a91aa0a65e0 48951-8025 HUMAN OTC DRUG Phosphorus 30 Special Order Phosphorus 30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS 30 [hp_X]/1 N 20181231 48951-8026_56f5883e-887d-3f3e-e054-00144ff8d46c 48951-8026 HUMAN OTC DRUG Phosphorus 6 Phosphorus 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS 6 [hp_X]/mL N 20181231 48951-8027_55df1359-3bdd-20bf-e054-00144ff8d46c 48951-8027 HUMAN OTC DRUG Phosphorus 8 Phosphorus 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS 8 [hp_X]/mL N 20181231 48951-8028_98fb582c-9f99-422b-a7c3-16185654bd25 48951-8028 HUMAN OTC DRUG Phosphorus 8 Special Order Phosphorus 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHOSPHORUS 8 [hp_X]/1 N 20181231 48951-8029_55df46f4-bff4-2896-e054-00144ff8d46c 48951-8029 HUMAN OTC DRUG Phosphorus comp. Phosphorus comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC SULFATE; SUS SCROFA PANCREAS; PHOSPHORUS; ROSMARINUS OFFICINALIS FLOWERING TOP; AMBER; SILICON DIOXIDE; SILVER 4; 6; 6; 6; 6; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8030_56f574f3-acdf-6df3-e054-00144ff88e88 48951-8030 HUMAN OTC DRUG Phosphorus comp. Phosphorus comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC SULFATE; SUS SCROFA PANCREAS; PHOSPHORUS; ROSMARINUS OFFICINALIS FLOWERING TOP; AMBER; SILICON DIOXIDE; SILVER 4; 6; 6; 6; 6; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8031_56f540f0-f3ce-3149-e054-00144ff8d46c 48951-8031 HUMAN OTC DRUG Phosphorus Tartarus Phosphorus Tartarus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY POTASSIUM TARTRATE; PHOSPHORUS 3; 6 1/mL; 1/mL N 20181231 48951-8032_55dee711-0cce-1080-e054-00144ff8d46c 48951-8032 HUMAN OTC DRUG Placenta (bovis) 6 Special Order Placenta (bovis) 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PLACENTA 6 [hp_X]/mL N 20181231 48951-8034_55df46f4-c01b-2896-e054-00144ff8d46c 48951-8034 HUMAN OTC DRUG Plantago Primula Plantago Primula LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PLANTAGO MAJOR LEAF; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF 2; 2; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8035_577137a3-12ec-1007-e053-2991aa0a594c 48951-8035 HUMAN OTC DRUG Plantago Primula Plantago Primula PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PLANTAGO MAJOR LEAF; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF 1; 1; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8036_55dee711-0cdb-1080-e054-00144ff8d46c 48951-8036 HUMAN OTC DRUG Plantago Pyrite Plantago Pyrite LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; ABIES ALBA LEAFY TWIG; PLANTAGO MAJOR LEAF; SAGE; FERROSOFERRIC PHOSPHATE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; BEEF LUNG; THYROID, BOVINE; FERROUS DISULFIDE; BOS TAURUS NASAL MUCOSA 3; 6; 6; 6; 7; 8; 8; 17; 17; 17; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8037_57723d12-a65c-61f0-e053-2991aa0af8e8 48951-8037 HUMAN OTC DRUG Plantago Pyrite Plantago Pyrite PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; PICEA ABIES LEAF; PLANTAGO MAJOR LEAF; SAGE; FERROSOFERRIC PHOSPHATE; BRYONIA ALBA ROOT; EUPATORIUM CANNABINUM FLOWERING TOP; BEEF LUNG; THYROID, BOVINE; FERROUS DISULFIDE; BOS TAURUS NASAL MUCOSA 3; 6; 6; 6; 7; 8; 8; 17; 17; 17; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8038_a3e4fd35-4e7a-4dcd-900b-be65e6651f79 48951-8038 HUMAN OTC DRUG Plantain Beeswax Cough Relief Plantain Beeswax Cough Relief OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LARIX DECIDUA RESIN; SAGE; DROSERA ROTUNDIFOLIA; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF 1; 3; 4; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8039_34ad2313-e2c5-42eb-a810-9c312a91a423 48951-8039 HUMAN OTC DRUG Plantain Beeswax Mild Cough Relief Plantain Beeswax Mild Cough Relief OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LARIX DECIDUA RESIN; SAGE; DROSERA ROTUNDIFOLIA; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF 1; 3; 4; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8041_55502e8d-654a-17a6-e054-00144ff8d46c 48951-8041 HUMAN OTC DRUG Plantain Spruce Cough PLANTAGO LANCEOLATA DROSERA ROTUNDIFOLIA ATROPA BELLADONNA CINCHONA OFFICINALIS BARK PROTORTONIA CACTI IPECAC HELLEBORUS VERATRUM ALBUM ROOT SYRUP ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc PLANTAGO LANCEOLATA; DROSERA ROTUNDIFOLIA; ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; PROTORTONIA CACTI; IPECAC; HELLEBORUS; VERATRUM ALBUM ROOT 1; 5; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8042_113bb558-234c-4173-b47a-dac9f0b9b919 48951-8042 HUMAN OTC DRUG Platinum Cichorium Platinum Cichorium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CICHORIUM INTYBUS WHOLE; OXALIS MONTANA LEAF; ROSMARINUS OFFICINALIS FLOWERING TOP; ACTIVATED CHARCOAL; SUS SCROFA PANCREAS; PLATINUM 3; 3; 3; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8043_6803f2d2-2736-4d5c-9340-0ffa5e303bb0 48951-8043 HUMAN OTC DRUG Platinum Cichorium Platinum Cichorium PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CICHORIUM INTYBUS WHOLE; OXALIS MONTANA LEAF; ROSMARINUS OFFICINALIS FLOWERING TOP; ACTIVATED CHARCOAL; SUS SCROFA PANCREAS; PLATINIC CHLORIDE 3; 3; 3; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8046_22457f9d-9628-4135-b5be-14ee393e9756 48951-8046 HUMAN OTC DRUG Plexus coeliacus 6 Special Order Plexus coeliacus 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS NERVE 6 [hp_X]/mL N 20181231 48951-8052_5796db07-ce63-d3ce-e053-2a91aa0a0720 48951-8052 HUMAN OTC DRUG Plumbum 5 Plumbum 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD 5 [hp_X]/g N 20181231 48951-8053_54fbfb4b-b4a8-403f-a240-90aa42785244 48951-8053 HUMAN OTC DRUG Plumbum 8 Special Order Plumbum 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD 8 [hp_X]/mL N 20181231 48951-8055_3dd413a2-d997-49e9-a922-15d60ad31de8 48951-8055 HUMAN OTC DRUG Plumbum mellitum 12 Special Order Plumbum mellitum 12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD; HONEY 12; 12 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8056_ff0bc259-db09-400f-b15e-ae6ccc335981 48951-8056 HUMAN OTC DRUG Plumbum mellitum 20 Special Order Plumbum mellitum 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD; HONEY 20; 20 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8057_ae12463c-a950-4b24-aeb6-e50982a9e61a 48951-8057 HUMAN OTC DRUG Plumbum mellitum 8 Plumbum mellitum 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HONEY; LEAD 8; 8 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8058_56f66508-b6ec-6581-e054-00144ff8d46c 48951-8058 HUMAN OTC DRUG Plumbum silicicum 20 Special Order Plumbum silicicum 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD MONOSILICATE 20 [hp_X]/mL N 20181231 48951-8065_55e013e1-48cd-1d15-e054-00144ff88e88 48951-8065 HUMAN OTC DRUG Primula Onopordon Special Order Primula Onopordon Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF 3; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8067_d391ca8b-62ff-4c5a-a357-fe282edf40ea 48951-8067 HUMAN OTC DRUG Primula Scilla Special Order Primula Scilla Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; HAWTHORN LEAF WITH FLOWER; MELISSA OFFICINALIS; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; DRIMIA MARITIMA BULB; HYOSCYAMUS NIGER LEAF; BEEF HEART; OSTREA EDULIS SHELL 3; 3; 3; 3; 3; 3; 3; 4; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8068_5771bef7-ed11-3a56-e053-2991aa0ab542 48951-8068 HUMAN OTC DRUG Primula Scilla Primula Scilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; HAWTHORN LEAF WITH FLOWER; MELISSA OFFICINALIS; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; DRIMIA MARITIMA BULB; HYOSCYAMUS NIGER LEAF; BEEF HEART; OSTREA EDULIS SHELL 3; 3; 3; 3; 3; 3; 3; 4; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8076_ddc09cbb-3661-4d59-bdb9-f259180ff9e4 48951-8076 HUMAN OTC DRUG Prunus Prunus LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 1 [hp_X]/mL N 20181231 48951-8077_55e0248f-233d-1ea6-e054-00144ff88e88 48951-8077 HUMAN OTC DRUG Prunus Iron Prunus Iron LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE; FERRIC OXIDE RED 6; 6 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8078_55dfc385-0405-35d5-e054-00144ff8d46c 48951-8078 HUMAN OTC DRUG Prunus spinosa e flor. et summ. 2 Prunus spinosa e flor. et summ. 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PRUNUS SPINOSA FLOWER BUD 2 [hp_X]/mL N 20181231 48951-8079_55e07e54-a0f3-2a58-e054-00144ff88e88 48951-8079 HUMAN OTC DRUG Prunus spinosa e flor. et summ. 5 Prunus spinosa e flor. et summ. 5 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 1 [hp_X]/mL N 20181231 48951-8080_65874bec-74af-4b88-8d3e-902498085870 48951-8080 HUMAN OTC DRUG Prunus spinosa e flor. et summ. 6 Prunus spinosa e flor. et summ. 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 6 [hp_X]/mL N 20181231 48951-8081_1406e3ea-13d5-436f-ba0a-f6dd0afb970b 48951-8081 HUMAN OTC DRUG Prunus spinosa e flor. et summ. 6 Special Order Prunus spinosa e flor. et summ. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 6 [hp_X]/mL N 20181231 48951-8082_c26c7548-d3a3-40ae-9dfe-1064c66f9cde 48951-8082 HUMAN OTC DRUG Prunus spinosa e summ 10% Prunus spinosa e summ 10% LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PRUNUS SPINOSA WHOLE 10 g/1 N 20181231 48951-8083_55ee333e-bdba-0672-e054-00144ff88e88 48951-8083 HUMAN OTC DRUG Pulmo 8 Pulmo 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA LUNG 8 [hp_X]/mL N 20181231 48951-8084_55ee491f-69a9-0801-e054-00144ff88e88 48951-8084 HUMAN OTC DRUG Pulmo Bryonia Pulmo Bryonia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; ANTIMONY POTASSIUM TARTRATE; FERROSOFERRIC PHOSPHATE; SUS SCROFA LUNG 6; 6; 8; 8; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8085_55ee491f-69b6-0801-e054-00144ff88e88 48951-8085 HUMAN OTC DRUG Pulmo Echinacea Pulmo Echinacea LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA; ASTRAGALUS PROPINQUUS ROOT; ATROPA BELLADONNA; TARAXACUM PALUSTRE ROOT; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; SUS SCROFA LUNG; SILVER 2; 3; 3; 4; 6; 12; 17; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8086_5771bef7-ed06-3a56-e053-2991aa0ab542 48951-8086 HUMAN OTC DRUG Pulmo Echinacea Pulmo Echinacea PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA; ASTRAGALUS PROPINQUUS ROOT; ATROPA BELLADONNA; TARAXACUM PALUSTRE ROOT; FERROSOFERRIC PHOSPHATE; LACHESIS MUTA VENOM; SUS SCROFA LUNG; SILVER 2; 3; 3; 4; 6; 12; 17; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8087_55ee491f-69c4-0801-e054-00144ff88e88 48951-8087 HUMAN OTC DRUG Pulmo Ferrum Pulmo Ferrum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA LUNG; IRON 17; 8 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8088_5771bef7-ecf7-3a56-e053-2991aa0ab542 48951-8088 HUMAN OTC DRUG Pulmo Ferrum Pulmo Ferrum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON; SUS SCROFA LUNG 8; 17 [hp_X]/1; [hp_X]/1 N 20181231 48951-8089_55ee491f-69ff-0801-e054-00144ff88e88 48951-8089 HUMAN OTC DRUG Pulmo Mercurius Pulmo Mercurius LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA LUNG; MERCURY 8; 17 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8091_55ee8dd0-96a5-5109-e054-00144ff8d46c 48951-8091 HUMAN OTC DRUG Pulmo Tartarus 17/8 Special Order Pulmo Tartarus 17/8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IRON; ANTIMONY POTASSIUM TARTRATE; SUS SCROFA LUNG 8; 8; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8092_55ee8dd0-96b4-5109-e054-00144ff8d46c 48951-8092 HUMAN OTC DRUG Pulmo Tartarus 6/8 Pulmo Tartarus 6/8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA LUNG; ANTIMONY POTASSIUM TARTRATE 6; 8 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8093_5771d032-ffd6-50f7-e053-2991aa0a98f4 48951-8093 HUMAN OTC DRUG Pulmo Tartarus 6/8 Pulmo Tartarus 6/8 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA LUNG; IRON; ANTIMONY POTASSIUM TARTRATE 6; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8094_7ba315ee-ded7-4960-8821-b5e2ae702002 48951-8094 HUMAN OTC DRUG Pulpa dentis 30 Special Order Pulpa dentis 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA TOOTH 30 [hp_X]/mL N 20181231 48951-8097_56f5883e-888b-3f3e-e054-00144ff8d46c 48951-8097 HUMAN OTC DRUG Pulsatilla e flor. 6 Special Order Pulsatilla e flor. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PULSATILLA VULGARIS 6 [hp_X]/mL N 20181231 48951-8098_55ee98dc-4bb6-5411-e054-00144ff8d46c 48951-8098 HUMAN OTC DRUG Pulsatilla Tormentilla Pulsatilla Tormentilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; MAGNESIUM HYDROXIDE; PULSATILLA VULGARIS; POTENTILLA ERECTA ROOT 4; 4; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8099_56f71f04-8451-1f08-e054-00144ff8d46c 48951-8099 HUMAN OTC DRUG Pulsatilla Tormentilla Pulsatilla Tormentilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MAMMAL LIVER; MAGNESIUM HYDROXIDE; PULSATILLA VULGARIS; POTENTILLA ERECTA ROOT 4; 4; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8100_da55e5a0-e678-11de-8a39-0800200c9a66 48951-8100 HUMAN OTC DRUG Pulsatilla Tormentilla PMS Relief MAMMAL LIVER PULSATILLA VULGARIS ACHILLEA MILLEFOLIUM PELLET ORAL 20091211 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc MAMMAL LIVER; PULSATILLA VULGARIS; ACHILLEA MILLEFOLIUM 4; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8102_ce765470-04e7-4084-8ddf-5ac62a982024 48951-8102 HUMAN OTC DRUG Pyrite 8 Pyrite 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERROUS DISULFIDE 8 [hp_X]/mL N 20181231 48951-8103_89318414-3d01-4740-9403-136be5f62c33 48951-8103 HUMAN OTC DRUG Pyrite Salvia Pyrite Salvia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SAGE; ANGELICA ARCHANGELICA ROOT; HYOSCYAMUS NIGER LEAF; FERROUS DISULFIDE; SILVER; HYACINTHUS ORIENTALIS WHOLE 3; 5; 7; 7; 15; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8104_56f71f04-8436-1f08-e054-00144ff8d46c 48951-8104 HUMAN OTC DRUG Pyrite Salvia Pyrite Salvia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SAGE; ANGELICA ARCHANGELICA ROOT; HYOSCYAMUS NIGER LEAF; FERROUS DISULFIDE; SILVER; HYACINTHUS ORIENTALIS WHOLE 3; 5; 7; 7; 15; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8106_0063aa03-2afa-4bfd-87f8-4fc2dde3e316 48951-8106 HUMAN OTC DRUG Quartz 20 Special Order Quartz 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 20 [hp_X]/mL N 20181231 48951-8108_55ef703e-9855-72ed-e054-00144ff8d46c 48951-8108 HUMAN OTC DRUG Quartz 30 Quartz 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILICON DIOXIDE 30 [hp_X]/mL N 20181231 48951-8109_55ef3639-2af2-6dbf-e054-00144ff8d46c 48951-8109 HUMAN OTC DRUG Quartz 8 Quartz 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILICON DIOXIDE 8 [hp_X]/mL N 20181231 48951-8110_55ef60e5-bbfa-313f-e054-00144ff88e88 48951-8110 HUMAN OTC DRUG Quartz Nicotiana Special Order Quartz Nicotiana Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; HAMAMELIS VIRGINIANA LEAF; TOBACCO LEAF; SILICON DIOXIDE 3; 3; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8111_5d81efb2-ca1f-4b24-8f08-47683526f875 48951-8111 HUMAN OTC DRUG Quartz Oxalis Nicotiana Quartz Oxalis Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; TOBACCO LEAF; OXALIS MONTANA LEAF; COLLOIDAL SILICON DIOXIDE 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8113_335ef225-0f5c-4fe2-9640-c300c29a84aa 48951-8113 HUMAN OTC DRUG Quercus 5 Quercus 5 OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE 1 [hp_X]/g N 20181231 48951-8115_57e76968-925b-6692-e053-2a91aa0a9f23 48951-8115 HUMAN OTC DRUG Quercus Borago Adult Size Quercus Borago Adult Size SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AESCULUS HIPPOCASTANUM BARK; BORAGE; MILK THISTLE; HAMAMELIS VIRGINIANA LEAF; QUERCUS ROBUR WHOLE; MERCURIALIS PERENNIS; ANTIMONY 3; 3; 3; 3; 1; 2; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8116_e0412273-1f0a-43ee-a9d4-52a66f88876b 48951-8116 HUMAN OTC DRUG Quercus Borago Hemorrhoid Relief Quercus Borago Hemorrhoid Relief OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE; MERCURIALIS PERENNIS; HORSE CHESTNUT; BORAGE; MILK THISTLE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ANTIMONY 1; 1; 1; 1; 1; 1; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8117_55ef7e8c-85ca-335c-e054-00144ff88e88 48951-8117 HUMAN OTC DRUG Quercus Cinis Quercus Cinis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE 5 [hp_X]/mL N 20181231 48951-8119_437ede4e-68e2-4aba-9eae-5d9e9ef5615a 48951-8119 HUMAN OTC DRUG Quercus Essence Quercus Essence LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. QUERCUS ROBUR WHOLE 1 [hp_X]/mL N 20181231 48951-8121_44780b9e-7300-410b-a365-c9214c7f26ce 48951-8121 HUMAN OTC DRUG Rectum 6 Special Order Rectum 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA RECTUM 6 [hp_X]/mL N 20181231 48951-8124_55ef9598-0c31-06a9-e054-00144ff8d46c 48951-8124 HUMAN OTC DRUG Renes Argentum nitricum Renes Argentum nitricum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PORK KIDNEY; SILVER 17; 20 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8125_56f71f04-841b-1f08-e054-00144ff8d46c 48951-8125 HUMAN OTC DRUG Renes Betula Renes Betula LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ELYMUS REPENS TOP; ONONIS REPENS ROOT; PARSLEY; CAPSELLA BURSA-PASTORIS; ARCTOSTAPHYLOS UVA-URSI LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; BETULA PUBESCENS LEAF; EQUISETUM ARVENSE TOP; PORK KIDNEY; CYTISUS SCOPARIUS FLOWERING TOP; COPPER 2; 2; 2; 2; 2; 2; 3; 3; 3; 3; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8126_55efd857-d14e-4166-e054-00144ff88e88 48951-8126 HUMAN OTC DRUG Renes Carbo Renes Carbo LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PORK KIDNEY; ACTIVATED CHARCOAL 6; 20 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8127_55efd857-d15b-4166-e054-00144ff88e88 48951-8127 HUMAN OTC DRUG Renes Cuprum Renes Cuprum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; PORK KIDNEY; COPPER 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8128_56f6f18f-55da-1478-e054-00144ff8d46c 48951-8128 HUMAN OTC DRUG Renes Cuprum Special Order Renes Cuprum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PORK KIDNEY; COPPER 6; 8 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8129_577288ed-5923-bd0d-e053-2991aa0aa5c6 48951-8129 HUMAN OTC DRUG Renes Cuprum Renes Cuprum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ADRENAL GLAND; PORK KIDNEY; COPPER 6; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8130_55ef675e-97b3-3230-e054-00144ff88e88 48951-8130 HUMAN OTC DRUG Renes Mesenchyme Renes Mesenchyme LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BORAGE; CUPRIC ACETATE; BOS TAURUS CONJUNCTIVA; BOS TAURUS LYMPH VESSEL; SUS SCROFA UMBILICAL CORD; BOS TAURUS CARTILAGE; PORK KIDNEY; VISCUM ALBUM FRUITING TOP 6; 6; 8; 8; 8; 8; 8; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8131_577288ed-5915-bd0d-e053-2991aa0aa5c6 48951-8131 HUMAN OTC DRUG Renes Mesenchyme Renes Mesenchyme LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BORAGE; CUPRIC ACETATE; BOS TAURUS CONJUNCTIVA; BOS TAURUS LYMPH VESSEL; SUS SCROFA UMBILICAL CORD; BOS TAURUS CARTILAGE; PORK KIDNEY; VISCUM ALBUM FRUITING TOP 6; 6; 8; 8; 8; 8; 8; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8132_55f01fe0-ebdc-4a92-e054-00144ff88e88 48951-8132 HUMAN OTC DRUG Renes Veratrum Renes Veratrum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VERATRUM ALBUM ROOT; PORK KIDNEY; EQUISETUM ARVENSE TOP; VISCUM ALBUM FRUITING TOP; APIS MELLIFERA 6; 7; 20; 20; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8133_57723d12-a66b-61f0-e053-2991aa0af8e8 48951-8133 HUMAN OTC DRUG Renes Veratrum Renes Veratrum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VERATRUM ALBUM ROOT; PORK KIDNEY; EQUISETUM ARVENSE TOP; VISCUM ALBUM FRUITING TOP; APIS MELLIFERA 6; 7; 20; 20; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8135_55f01fa9-8285-4a94-e054-00144ff88e88 48951-8135 HUMAN OTC DRUG Reticuloendothelial system 8 Special Order Reticuloendothelial system 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF LIVER 8 [hp_X]/mL N 20181231 48951-8140_55f01fa9-8293-4a94-e054-00144ff88e88 48951-8140 HUMAN OTC DRUG Rhus Aconitum Rhus Aconitum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GELSEMIUM SEMPERVIRENS ROOT; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; ACONITUM NAPELLUS; ATROPA BELLADONNA; MANDRAGORA OFFICINARUM ROOT; TOXICODENDRON PUBESCENS LEAF; PENOXSULAM 4; 4; 6; 6; 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8142_5780d136-25e4-2988-e053-2a91aa0a2ac1 48951-8142 HUMAN OTC DRUG Rhus Aconitum Rhus Aconitum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GELSEMIUM SEMPERVIRENS ROOT; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; MANDRAGORA OFFICINARUM ROOT; TOXICODENDRON PUBESCENS LEAF; ATROPA BELLADONNA; PENOXSULAM 3; 4; 4; 4; 4; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8143_55efe92b-128a-0a1e-e054-00144ff8d46c 48951-8143 HUMAN OTC DRUG Rhus Tox. e fol. 4 Rhus Tox. e fol. 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TOXICODENDRON PUBESCENS LEAF 4 [hp_X]/mL N 20181231 48951-8144_55f0524e-3057-1c64-e054-00144ff8d46c 48951-8144 HUMAN OTC DRUG Robinia Nicotiana Robinia Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROBINIA PSEUDOACACIA BARK; SILVER; BOS TAURUS ADRENAL GLAND; TOBACCO LEAF; STRYCHNOS NUX-VOMICA SEED; COPPER; SODIUM PHOSPHATE 4; 6; 6; 6; 6; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8145_56f6f18f-55ca-1478-e054-00144ff8d46c 48951-8145 HUMAN OTC DRUG Robinia Nicotiana Robina Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROBINIA PSEUDOACACIA BARK; SILVER; BOS TAURUS ADRENAL GLAND; TOBACCO LEAF; STRYCHNOS NUX-VOMICA SEED; COPPER; SODIUM PHOSPHATE 4; 6; 6; 6; 6; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8146_5780c9e4-5db7-270c-e053-2a91aa0a36ba 48951-8146 HUMAN OTC DRUG Robinia Nicotiana Robinia Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROBINIA PSEUDOACACIA BARK; SILVER; SUS SCROFA ADRENAL GLAND; TOBACCO LEAF; STRYCHNOS NUX-VOMICA SEED; COPPER; SODIUM PHOSPHATE 4; 6; 6; 6; 6; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8149_cd31f860-3a39-45de-8ea8-7037cc8b6d7e 48951-8149 HUMAN OTC DRUG Rose Iron Graphite Rose Iron Graphite LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERRIC OXIDE RED; SEDUM ROSEUM WHOLE; GRAPHITE 6; 6; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8150_5780d136-25d7-2988-e053-2a91aa0a2ac1 48951-8150 HUMAN OTC DRUG Rose iron Graphite Rose iron Graphite PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FERRIC OXIDE RED; SEDUM ROSEUM WHOLE; GRAPHITE 6; 6; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8154_55f01fe0-ec36-4a92-e054-00144ff88e88 48951-8154 HUMAN OTC DRUG Rosmarinus Argentum Rosmarinus Argentum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TARAXACUM OFFICINALE ROOT; ROSMARINUS OFFICINALIS FLOWERING TOP; AMBER; SILVER 3; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8155_55f01fe0-ec43-4a92-e054-00144ff88e88 48951-8155 HUMAN OTC DRUG Rosmarinus e fol. 1% Special Order Rosmarinus e fol. 1% Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROSMARINUS OFFICINALIS FLOWERING TOP 2 [hp_X]/mL N 20181231 48951-8156_5aa1ec2e-8f96-49ab-99b7-f39d8b309946 48951-8156 HUMAN OTC DRUG Rosmarinus ex herba 3 Special Order Rosmarinus ex herba 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROSMARINUS OFFICINALIS FLOWERING TOP 3 [hp_X]/mL N 20181231 48951-8157_57d213e3-fda2-70b1-e053-2991aa0a2e9b 48951-8157 HUMAN OTC DRUG Rosmarinus Lavandula Rosmarinus Lavandula GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF; OSTREA EDULIS SHELL; SUS SCROFA SKIN; SUS SCROFA UMBILICAL CORD; BOS TAURUS PLACENTA; BOS TAURUS SOMATIC NERVE; TIN 8; 8; 8; 8; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8158_55f11a98-4602-433e-e054-00144ff8d46c 48951-8158 HUMAN OTC DRUG Rosmarinus Poterium Rosmarinus Poterium LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SANGUISORBA OFFICINALIS ROOT; TARAXACUM PALUSTRE ROOT; ROSMARINUS OFFICINALIS FLOWERING TOP; AMBER; ROSEMARY OIL; SILVER 2; 3; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8159_5780c790-62ae-3fac-e053-2991aa0a09de 48951-8159 HUMAN OTC DRUG Sabal Populus Sabal Populus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; POPULUS TREMULA WHOLE; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS WHOLE; MAGNESITE 3; 3; 3; 3; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8161_56cbdbfe-8ef2-13fe-e054-00144ff88e88 48951-8161 HUMAN OTC DRUG Sabal Populus Sabal Populus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; POPULUS TREMULA WHOLE; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS WHOLE; MAGNESITE 3; 3; 3; 3; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8162_e35024da-9da2-45df-a006-2e7f05470b05 48951-8162 HUMAN OTC DRUG Sambucus Larix Sambucus Larix LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BLACK COHOSH; SAMBUCUS NIGRA FLOWERING TOP; LARIX DECIDUA RESIN 3; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8163_57809f20-37f7-1a3e-e053-2991aa0ad4df 48951-8163 HUMAN OTC DRUG Sambucus Larix Sambucus Larix PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BLACK COHOSH; SAMBUCUS NIGRA FLOWERING TOP; LARIX DECIDUA RESIN 3; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8164_cae663a2-865f-4d9a-89bf-2a3e36616383 48951-8164 HUMAN OTC DRUG Sarothamnus Aurum Special Order Sarothamnus Aurum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; CYTISUS SCOPARIUS FLOWER; SELENICEREUS GRANDIFLORUS STEM; CAMPHOR (NATURAL); HYOSCYAMUS NIGER LEAF; GOLD; BERYLLIUM 3; 3; 3; 4; 4; 4; 17; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8165_5780d3e2-8946-6217-e053-2a91aa0a602b 48951-8165 HUMAN OTC DRUG Sarothamnus Aurum Sarothamnus Aurum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; CYTISUS SCOPARIUS FLOWER; SELENICEREUS GRANDIFLORUS STEM; CAMPHOR (NATURAL); HYOSCYAMUS NIGER LEAF; GOLD; BERYLLIUM 3; 3; 3; 4; 4; 4; 17; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8166_792bc757-6b73-47c8-badc-6ca001e5a76f 48951-8166 HUMAN OTC DRUG Scilla Crataegus Scilla Crataegus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ADONIS VERNALIS FLOWERING TOP; HAWTHORN LEAF WITH FLOWER; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; CONVALLARIA MAJALIS; HYOSCYAMUS NIGER LEAF; DRIMIA MARITIMA BULB 3; 3; 3; 3; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8167_5780d3e2-893b-6217-e053-2a91aa0a602b 48951-8167 HUMAN OTC DRUG Scilla Crataegus Scilla Crataegus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ADONIS VERNALIS FLOWERING TOP; HAWTHORN LEAF WITH FLOWER; ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; CONVALLARIA MAJALIS; HYOSCYAMUS NIGER LEAF; DRIMIA MARITIMA BULB 3; 3; 3; 3; 4; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8168_56cbdbfe-8f01-13fe-e054-00144ff88e88 48951-8168 HUMAN OTC DRUG Scorodite Prunus Scorodite Prunus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CAMPHOR (NATURAL); VERATRUM ALBUM ROOT; SLOE; FERROUS ARSENATE; BOS TAURUS PITUITARY GLAND; GOLD 4; 4; 6; 6; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8169_5780d136-2626-2988-e053-2a91aa0a2ac1 48951-8169 HUMAN OTC DRUG Scorodite Prunus Scorodite Prunus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CAMPHOR (NATURAL); VERATRUM ALBUM ROOT; SLOE; FERROUS ARSENATE; BOS TAURUS PITUITARY GLAND; GOLD 4; 4; 6; 6; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8170_2a434c26-eeb0-41bd-8acc-7ef8c440bcca 48951-8170 HUMAN OTC DRUG Scorodite Saccharum Special Order Scorodite Saccharum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PARATHYROID GLAND; OXALIS MONTANA LEAF; FERROUS ARSENATE; SUGARCANE 6; 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8171_99f339e2-5ce3-4176-8e1e-09a6e96ef63f 48951-8171 HUMAN OTC DRUG Scorodite Saccharum Special Order Scorodite Saccharum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS PARATHYROID GLAND; FERROUS ARSENATE; OXALIS MONTANA LEAF; SUGARCANE 6; 6; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8172_f5db73f1-de5b-4ef1-8021-94a1fcefba8f 48951-8172 HUMAN OTC DRUG Secale Argentum Special Order Secale Argentum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARISTOLOCHIA CLEMATITIS WHOLE; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM; SILVER 3; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8173_57810927-8d46-6689-e053-2a91aa0adff6 48951-8173 HUMAN OTC DRUG Secale Argentum Special Order Secale Argentum Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARISTOLOCHIA CLEMATITIS WHOLE; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM; GOLD 3; 6; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8174_ec5fa9fe-a321-4e86-b896-a273fc9d65c3 48951-8174 HUMAN OTC DRUG Secale Betula Special Order Secale Betula Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; BETULA PUBESCENS BARK; LEVISTICUM OFFICINALE ROOT; TOBACCO LEAF; CLAVICEPS PURPUREA SCLEROTIUM; LEAD SULFIDE; BOS TAURUS EYE; ARNICA MONTANA 3; 4; 6; 6; 6; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8175_edcf38f1-7119-4ca7-abd8-33a2436256e6 48951-8175 HUMAN OTC DRUG Secale Betula Secale Betula PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; BETULA PUBESCENS BARK; LEVISTICUM OFFICINALE ROOT; TOBACCO LEAF; CLAVICEPS PURPUREA SCLEROTIUM; LEAD SULFIDE; BOS TAURUS EYE; ARNICA MONTANA 3; 4; 6; 6; 6; 8; 8; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8176_56cbdbfe-8f20-13fe-e054-00144ff88e88 48951-8176 HUMAN OTC DRUG Secale Nicotiana Secale Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; BETULA PUBESCENS BARK; TOBACCO LEAF; CLAVICEPS PURPUREA SCLEROTIUM; BOS TAURUS ARTERY; LEAD SULFIDE 3; 4; 6; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8177_5781599b-c2db-d0ed-e053-2a91aa0a4450 48951-8177 HUMAN OTC DRUG Secale Nicotiana Secale Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; BETULA PUBESCENS BARK; TOBACCO LEAF; CLAVICEPS PURPUREA SCLEROTIUM; BOS TAURUS ARTERY; LEAD SULFIDE 3; 4; 6; 6; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8178_56cc1385-b833-1a72-e054-00144ff88e88 48951-8178 HUMAN OTC DRUG Secale Quartz Secale Quartz LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SANGUINARIA CANADENSIS ROOT; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8180_578150a6-0c62-2373-e053-2991aa0a8e85 48951-8180 HUMAN OTC DRUG Secale Quartz Secale Quartz PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SANGUINARIA CANADENSIS ROOT; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE 6; 6; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8182_b8a246e2-1493-409a-a9ef-81cff84633f0 48951-8182 HUMAN OTC DRUG Silica 12 Special Order Silica 12 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 12 [hp_X]/1 N 20181231 48951-8183_18a6e33e-d03f-4f42-a667-a5b27611ae3f 48951-8183 HUMAN OTC DRUG Silica 20 Special Order Silica 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 20 [hp_X]/mL N 20181231 48951-8185_56f7feb8-3bdb-46e0-e054-00144ff88e88 48951-8185 HUMAN OTC DRUG Silica 8 Silica 8 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILICON DIOXIDE 8 [hp_X]/mL N 20181231 48951-8187_56cc1385-b841-1a72-e054-00144ff88e88 48951-8187 HUMAN OTC DRUG Silicea Belladonna Silicea Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; ATROPA BELLADONNA; SILICON DIOXIDE 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8189_5780c9e4-5e31-270c-e053-2a91aa0a36ba 48951-8189 HUMAN OTC DRUG Silicea Belladonna Silicea Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; ATROPA BELLADONNA; SILICON DIOXIDE 20; 20; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8192_57819843-176e-158d-e053-2a91aa0acae9 48951-8192 HUMAN OTC DRUG Solanum lycopersicum 4 Solanum lycopersicum 4 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SOLANUM LYCOPERSICUM 4 [hp_X]/1 N 20181231 48951-8193_56cc1385-b852-1a72-e054-00144ff88e88 48951-8193 HUMAN OTC DRUG Solum Aesculus Solum Aesculus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; EQUISETUM ARVENSE TOP; ST. JOHN'S WORT; SPHAGNUM SQUARROSUM PEAT 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8197_5780c9e4-5e25-270c-e053-2a91aa0a36ba 48951-8197 HUMAN OTC DRUG Solum Aesculus Sensitivity Solum Aesculus Sensitivity PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; EQUISETUM ARVENSE TOP; ST. JOHN'S WORT; SPHAGNUM SQUARROSUM PEAT 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8200_b2b32b1c-3165-49f1-8b11-c79dbce62263 48951-8200 HUMAN OTC DRUG Spongia Aurum Special Order Spongia Aurum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PULSATILLA VULGARIS; SLOE; SEPIA OFFICINALIS JUICE; SILVER; CALCIUM CARBONATE; SUGARCANE; SPONGIA OFFICINALIS SKELETON, ROASTED 4; 6; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8201_57819843-1760-158d-e053-2a91aa0acae9 48951-8201 HUMAN OTC DRUG Spongia Aurum Spongia Aurum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PRUNUS SPINOSA FLOWER BUD; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; GOLD; CALCIUM CARBONATE; SUGARCANE; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 7; 7; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8203_57819843-1752-158d-e053-2a91aa0acae9 48951-8203 HUMAN OTC DRUG Spongia Ovi Spongia Ovi PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SPONGIA OFFICINALIS SKELETON, ROASTED; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE WHOLE; CALCIUM CARBONATE; SUGARCANE 1; 3; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8204_1b0afa56-585a-4aff-811a-d5713e7aa0e6 48951-8204 HUMAN OTC DRUG Stannum 10 Special Order Stannum 10 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 10 [hp_X]/mL N 20181231 48951-8206_57d16cf9-d198-59fb-e053-2a91aa0ac0bb 48951-8206 HUMAN OTC DRUG Stannum 5 Stannum 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 5 [hp_X]/g N 20181231 48951-8207_57e5ec6f-f9f5-4462-e053-2a91aa0aa907 48951-8207 HUMAN OTC DRUG Stannum 5 Stannum 5 OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 1 [hp_X]/g N 20181231 48951-8208_57facfb3-3ae9-5dfc-e053-2991aa0a52a9 48951-8208 HUMAN OTC DRUG Stannum Succinum Stannum Succinum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. AMBER; TIN 6; 6 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8210_57e5ed64-134c-658e-e053-2a91aa0aff82 48951-8210 HUMAN OTC DRUG Stannum 0.4 Stannum 0.4 OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 1 [hp_X]/g N 20181231 48951-8211_56cc1385-b88d-1a72-e054-00144ff88e88 48951-8211 HUMAN OTC DRUG Stibium 20 Stibium 20 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 20 [hp_X]/mL N 20181231 48951-8212_57d19658-14dc-45ad-e053-2a91aa0a8483 48951-8212 HUMAN OTC DRUG Stibium 5 Stibium 5 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 5 [hp_X]/g N 20181231 48951-8213_56cc1385-b899-1a72-e054-00144ff88e88 48951-8213 HUMAN OTC DRUG Stibium 6 Stibium 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 6 [hp_X]/mL N 20181231 48951-8214_27e8cf87-db1e-4944-a6a7-2d9d50cae22c 48951-8214 HUMAN OTC DRUG Stibium 6 Special Order Stibium 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 6 [hp_X]/mL N 20181231 48951-8216_9cb970f7-3c70-4cb7-b578-36e1f4fb8c08 48951-8216 HUMAN OTC DRUG Strophanthus Aurum Strophanthus Aurum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; STROPHANTHUS KOMBE WHOLE; ANTIMONY; GOLD 3; 3; 4; 5; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8217_57816443-bbea-0946-e053-2991aa0a3a10 48951-8217 HUMAN OTC DRUG Strophanthus Aurum Strophanthus Aurum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; STROPHANTHUS KOMBE WHOLE; ANTIMONY; GOLD 3; 3; 4; 5; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8218_6c9cca5f-502f-4804-9182-321ab1a7c8d6 48951-8218 HUMAN OTC DRUG Strophanthus Nicotiana Strophanthus Nicotiana LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STROPHANTHUS HISPIDUS SEED; TOBACCO LEAF; HONEY; LEAD 6; 10; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8219_57819843-173f-158d-e053-2a91aa0acae9 48951-8219 HUMAN OTC DRUG Strophanthus Nicotiana Strophanthus Nicotiana PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STROPHANTHUS HISPIDUS SEED; TOBACCO LEAF; LEAD; HONEY 6; 10; 15; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8220_5b8b705c-aebe-429a-a706-1a576f55bece 48951-8220 HUMAN OTC DRUG Sulfur 30 Special Order Sulfur 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SULFUR 30 [hp_X]/mL N 20181231 48951-8221_56f7f29a-cf27-4573-e054-00144ff8d46c 48951-8221 HUMAN OTC DRUG Sulfur 6 Sulfur 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SULFUR 6 [hp_X]/mL N 20181231 48951-8222_56f887a8-3086-6146-e054-00144ff8d46c 48951-8222 HUMAN OTC DRUG Symphytum Hamamelis Symphytum Hamamelis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COMFREY ROOT; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA TOP; RUTA GRAVEOLENS FLOWERING TOP; ONION; ARNICA MONTANA; BELLIS PERENNIS 2; 3; 3; 3; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8223_54dbf0f3-0579-415b-a84c-42683fda23b4 48951-8223 HUMAN OTC DRUG Symphytum Stannum Symphytum Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; ARNICA MONTANA; COMFREY ROOT; TIN 3; 3; 3; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8224_57817ecc-38ed-b240-e053-2a91aa0a0120 48951-8224 HUMAN OTC DRUG Symphytum Stannum Bone Support Symphytum Stannum Bone Support PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; ARNICA MONTANA; COMFREY ROOT; TIN 3; 3; 3; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8225_57e61a89-a11e-621c-e053-2991aa0a1c3e 48951-8225 HUMAN OTC DRUG Stibium 0.4 Stibium 0.4 OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 1 [hp_X]/g N 20181231 48951-8226_56f7f29a-cf49-4573-e054-00144ff8d46c 48951-8226 HUMAN OTC DRUG Sepia comp. Sepia comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STRYCHNOS IGNATII SEED; SEPIA OFFICINALIS JUICE; OSTREA EDULIS SHELL 5; 5; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8229_56f72c95-6391-30f6-e054-00144ff88e88 48951-8229 HUMAN OTC DRUG Pulmo Mercurius Special Order Pulmo Mercurius Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA LUNG; MERCURY 8; 17 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8230_56f7f29a-cf36-4573-e054-00144ff8d46c 48951-8230 HUMAN OTC DRUG Stibium 20 Special Order Stibium 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 20 [hp_X]/mL N 20181231 48951-8231_644fb606-fd15-46ef-aa6f-faeffa841595 48951-8231 HUMAN OTC DRUG Silica 30 Special Order Silica 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 30 [hp_X]/mL N 20181231 48951-8232_55ef7e8c-85d9-335c-e054-00144ff88e88 48951-8232 HUMAN OTC DRUG Regio substantiae nigrae 6 Special Order Regio substantiae nigrae 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAIN 6 [hp_X]/mL N 20181231 48951-8233_354e8ec7-2d33-4e14-b84c-5bbec04ad321 48951-8233 HUMAN OTC DRUG Rosmarinus Lavendula Special Order Rosmarinus Lavendula Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE; BEEF; CUPRIC OXIDE; OSTREA EDULIS SHELL; LAVANDULA ANGUSTIFOLIA FLOWER; SEDUM ROSEUM WHOLE; FERRIC OXIDE RED; ROSMARINUS OFFICINALIS FLOWERING TOP; TIN; URTICA DIOICA; SUS SCROFA SKIN; BOS TAURUS OVARY; BOS TAURUS PLACENTA 5; 6; 10; 10; 10; 10; 10; 10; 10; 10; 12; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8234_345d3f4a-8d33-4fa0-b6ae-d55e4301d799 48951-8234 HUMAN OTC DRUG Periodontium Quartz Special Order Periodontium Quartz Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CALENDULA OFFICINALIS FLOWERING TOP; ATROPA BELLADONNA; BEEF TONGUE; BOS TAURUS BONE; SUS SCROFA TOOTH; SILVER; COLLOIDAL SILICON DIOXIDE 3; 17; 17; 17; 17; 20; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8235_57729c22-ef6f-6549-e053-2a91aa0a7229 48951-8235 HUMAN OTC DRUG Renes Betula Special Order Renes Betula Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ELYMUS REPENS TOP; ONONIS REPENS ROOT; PARSLEY; CAPSELLA BURSA-PASTORIS; ARCTOSTAPHYLOS UVA-URSI LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; BETULA PUBESCENS LEAF; EQUISETUM ARVENSE TOP; CYTISUS SCOPARIUS FLOWERING TOP; PORK KIDNEY; COPPER 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8236_57729c22-ef61-6549-e053-2a91aa0a7229 48951-8236 HUMAN OTC DRUG Renes Carbo Special Order Renes Carbo Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PORK KIDNEY; ACTIVATED CHARCOAL 6; 20 [hp_X]/1; [hp_X]/1 N 20181231 48951-8237_8aa86a90-ed30-478f-8f3a-0622aa3375fc 48951-8237 HUMAN OTC DRUG Reticuloendothelial system 8 Special Order Reticuloendothelial system 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF LIVER 8 [hp_X]/1 N 20181231 48951-8238_421a06cb-faa3-4466-962a-99cf9c381432 48951-8238 HUMAN OTC DRUG Pancreas Meteoric Iron Special Order Pancreas Meteoric Iron Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROSMARINUS OFFICINALIS FLOWERING TOP; SUS SCROFA PANCREAS; IRON 4; 6; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8239_d745e31f-833e-463e-af55-2330930c83ac 48951-8239 HUMAN OTC DRUG Mandragora Arnica Special Order Mandragora Arnica Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA MENISCUS; FORMICA RUFA; ARNICA MONTANA; EQUISETUM ARVENSE TOP 3; 3; 6; 10; 15; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8240_b6e704ce-8652-40da-ad8a-50a48b02285a 48951-8240 HUMAN OTC DRUG Quartz Nicotiana Special Order Quartz Nicotiana Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; HAMAMELIS VIRGINIANA LEAF; TOBACCO LEAF; COLLOIDAL SILICON DIOXIDE 3; 3; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8241_55ef675e-97a5-3230-e054-00144ff88e88 48951-8241 HUMAN OTC DRUG Quartz 60 Special Order Quartz 60 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILICON DIOXIDE 60 [hp_X]/mL N 20181231 48951-8242_5796db07-ce55-d3ce-e053-2a91aa0a0720 48951-8242 HUMAN OTC DRUG Rhus tox. 1 Special Order Rhus tox. 1 Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TOXICODENDRON PUBESCENS LEAF 2 [hp_X]/g N 20181231 48951-8243_56cb51dd-c841-4e5e-e054-00144ff8d46c 48951-8243 HUMAN OTC DRUG Stannum 17 Special Order Stannum 17 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 17 [hp_X]/mL N 20181231 48951-8245_31177374-4326-446e-b67b-104f28c01f54 48951-8245 HUMAN OTC DRUG Pulmo Mercurius Special Order Pulmo Mercurius Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA LUNG; MERCURY 8; 17 [hp_X]/1; [hp_X]/1 N 20181231 48951-8246_15dccd61-8427-4c5e-a8ee-d2857f1c9574 48951-8246 HUMAN OTC DRUG Sulfur 6 Special Order Sulfur 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SULFUR 6 [hp_X]/mL N 20181231 48951-8247_2a918f39-1caa-4728-8af4-fb24ff4c1eab 48951-8247 HUMAN OTC DRUG Periosteum 8 Special Order Periosteum 8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE 8 [hp_X]/1 N 20181231 48951-8248_578203e7-60f2-40ad-e053-2991aa0aa3d6 48951-8248 HUMAN OTC DRUG Sulfur 30 Special Order Sulfur 30 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SULFUR 30 [hp_X]/1 N 20181231 48951-8249_d239666b-a1a3-4155-b5ac-6c40711ba5da 48951-8249 HUMAN OTC DRUG Rhus Aconitum Special Order Rhus Aconitum Special Order GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; EQUISETUM ARVENSE TOP; ACONITUM NAPELLUS; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; SLOE; TOXICODENDRON PUBESCENS LEAF; URTICA DIOICA LEAF; GOLD 3; 3; 5; 5; 5; 5; 5; 5; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8250_d83888f6-b280-4a62-a697-c7baba045e57 48951-8250 HUMAN OTC DRUG Strophanthus Aurum Special Order Strophanthus Aurum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF; STROPHANTHUS KOMBE WHOLE; ANTIMONY; GOLD 3; 3; 4; 5; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8251_57718ee8-c2fb-60e0-e053-2a91aa0a8271 48951-8251 HUMAN OTC DRUG Phosphorus comp. Special Order Phosphorus comp. Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC SULFATE; SUS SCROFA PANCREAS; PHOSPHORUS; ROSMARINUS OFFICINALIS FLOWERING TOP; AMBER; SILICON DIOXIDE; SILVER 4; 6; 6; 6; 6; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8252_56f5a172-d386-735c-e054-00144ff88e88 48951-8252 HUMAN OTC DRUG Passiflora Crataegus Special Order Passiflora Crataegus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; HAWTHORN LEAF WITH FLOWER; PASSIFLORA INCARNATA FLOWERING TOP; SALIX ALBA FLOWER 2; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8253_56f62eea-8684-5beb-e054-00144ff8d46c 48951-8253 HUMAN OTC DRUG Prunus spinosa e summ. 30 Special Order Prunus spinosa e summ. 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 1 [hp_X]/mL N 20181231 48951-8254_56f66508-b6fd-6581-e054-00144ff8d46c 48951-8254 HUMAN OTC DRUG Plantago Primula Special Order Plantago Primula Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PLANTAGO MAJOR LEAF; PRIMULA VERIS FLOWER; HYOSCYAMUS NIGER LEAF 1; 1; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8255_39c28a68-3aaf-4853-b9e4-7837383d3014 48951-8255 HUMAN OTC DRUG Prunus spinosa e fruct. 3 Special Order Prunus spinosa e fruct. 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 3 [hp_X]/mL N 20181231 48951-8256_ba065041-db92-4eb4-8de2-878507b85738 48951-8256 HUMAN OTC DRUG Phosphorus Coffea Special Order Phosphorus Coffea Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; VALERIAN; SILVER; PHOSPHORUS; SULFUR; GOLD; OSTREA EDULIS SHELL; COFFEA ARABICA SEED, ROASTED 5; 7; 20; 25; 25; 30; 30; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8257_3546dc87-14c5-4ee0-b5e2-854e36d811e9 48951-8257 HUMAN OTC DRUG Phytolacca e rad 6 Special Order Phytolacca e rad 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PHYTOLACCA AMERICANA ROOT 6 [hp_X]/mL N 20181231 48951-8258_c785b3a7-8615-4445-8b8b-179ece20f27f 48951-8258 HUMAN OTC DRUG Pulsatilla e flor. 30 Special Order Pulsatilla e flor. 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PULSATILLA VULGARIS 30 [hp_X]/mL N 20181231 48951-8259_55132937-1dfe-1e1a-e054-00144ff88e88 48951-8259 HUMAN OTC DRUG Pulsatilla e flor. 6 Special Order Pulsatilla e flor. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PULSATILLA VULGARIS 6 [hp_X]/mL N 20181231 48951-8260_e577b61e-ee56-47ee-a3a7-94cfb81baf31 48951-8260 HUMAN OTC DRUG Rosmarinus Formica Special Order Rosmarinus Formica Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STACHYS OFFICINALIS; BOS TAURUS SOMATIC NERVE; ROSMARINUS OFFICINALIS FLOWERING TOP; FORMICA RUFA; COLLOIDAL SILICON DIOXIDE; TIN; SILVER; ARNICA MONTANA ROOT 6; 6; 6; 7; 12; 17; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8261_f43c5aab-451c-4d51-89c3-a0d98c79b0ea 48951-8261 HUMAN OTC DRUG Pharynx 8 Special Order Pharynx 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS ESOPHAGUS 8 [hp_X]/mL N 20181231 48951-8262_d196d6d6-986c-4ba4-8490-9805e9508a58 48951-8262 HUMAN OTC DRUG Renes 5 Special Order Renes 5 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PORK KIDNEY 5 [hp_X]/mL N 20181231 48951-8263_cac29191-86d4-4120-9478-b2691aef2d18 48951-8263 HUMAN OTC DRUG Renes Pulmo 8/8/12 Special Order Renes Pulmo 8/8/12 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA LUNG; PORK KIDNEY 8; 8 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8265_d67ab06f-03d1-44ea-8bd3-4f34e10eef79 48951-8265 HUMAN OTC DRUG Rhus Aconitum Special Order Rhus Aconitum Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. GELSEMIUM SEMPERVIRENS ROOT; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; ACONITUM NAPELLUS; ATROPA BELLADONNA; MANDRAGORA OFFICINARUM ROOT; TOXICODENDRON PUBESCENS LEAF; PENOXSULAM 4; 4; 6; 6; 6; 6; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8266_899e065a-3356-4de9-bf57-923fcd154575 48951-8266 HUMAN OTC DRUG Plantago e fol. 4 Special Order Plantago e fol. 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PLANTAGO MAJOR LEAF 4 [hp_X]/mL N 20181231 48951-8268_d75a305b-d951-49a2-a183-80903650cf1f 48951-8268 HUMAN OTC DRUG Stannum mellitum 20 Special Order Stannum mellitum 20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HONEY; TIN 20; 20 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8269_56f5a172-d375-735c-e054-00144ff88e88 48951-8269 HUMAN OTC DRUG Periodontium Quartz Special Order Periodontium Quartz Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILICON DIOXIDE; CALENDULA OFFICINALIS FLOWERING TOP; ATROPA BELLADONNA; BEEF TONGUE; BOS TAURUS BONE; SUS SCROFA TOOTH; SILVER 30; 3; 17; 17; 17; 17; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8270_55e013e1-48c0-1d15-e054-00144ff88e88 48951-8270 HUMAN OTC DRUG Polygonatum Apis Special Order Polygonatum Apis Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; ECHINACEA ANGUSTIFOLIA; ROYAL JELLY; SILVER; HIRUDIN; POLYGONATUM CYRTONEMA ROOT; BOS TAURUS TESTICLE; VESPA CRABRO; GOLD; BOS TAURUS CARTILAGE; COPPER; SUS SCROFA SKIN; BOS TAURUS PLACENTA; SILICON DIOXIDE; THUJA OCCIDENTALIS WHOLE; BARIUM CITRATE; GRAPHITE 6; 6; 6; 6; 6; 8; 10; 10; 10; 10; 10; 10; 10; 10; 10; 14; 19 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8272_107df484-4e2c-4aa4-ae3f-cb29c466f189 48951-8272 HUMAN OTC DRUG Quartz Oxalis Nicotiana Special Order Quartz Oxalis Nicotiana Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COPPER; TIN; HORSE CHESTNUT; HAMAMELIS VIRGINIANA LEAF; TOBACCO LEAF; COLLOIDAL SILICON DIOXIDE 3; 3; 3; 3; 6; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8273_ddc49f1c-eaf2-4543-a7f9-039f96167691 48951-8273 HUMAN OTC DRUG Sepia comp Special Order Sepia comp Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STRYCHNOS IGNATII SEED; SEPIA OFFICINALIS JUICE; OSTREA EDULIS SHELL 5; 5; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8274_341db6bd-4319-489b-9322-53919a16803a 48951-8274 HUMAN OTC DRUG Solum Aesculus Essence Special Order Solum Aesculus Essence Special Order LIQUID TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HORSE CHESTNUT; EQUISETUM ARVENSE TOP; ST. JOHN'S WORT 2; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8275_3cad4a2a-ff02-4d8e-903b-e156ef01d289 48951-8275 HUMAN OTC DRUG Plumbum mellitum 30 Special Order Plumbum mellitum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HONEY; LEAD 30; 30 [hp_X]/mL; [hp_X]/mL N 20181231 48951-8276_dbfa0c6c-0f57-4d85-b34f-134c7bf8e7cc 48951-8276 HUMAN OTC DRUG Plantain Beeswax Cough Relief Special Order Plantain Beeswax Cough Relief Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SAGE; DROSERA ROTUNDIFOLIA; PETASITES HYBRIDUS ROOT; PLANTAGO MAJOR LEAF; LARIX DECIDUA RESIN 5; 6; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8277_50c80ab8-d040-482d-8e95-0c304911e98e 48951-8277 HUMAN OTC DRUG Silica 30 Special Order Silica 30 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COLLOIDAL SILICON DIOXIDE 30 [hp_X]/g N 20181231 48951-8278_febbef32-2e48-42ef-8442-cae2976d59a4 48951-8278 HUMAN OTC DRUG Rhus tox. e fol. 30 Special Order Rhus tox. e fol. 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TOXICODENDRON PUBESCENS LEAF 30 [hp_X]/mL N 20181231 48951-8279_44bc5ec7-0a1e-45fa-9aea-c2da03de728d 48951-8279 HUMAN OTC DRUG Stibium 30 Special Order Stibium 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 30 [hp_X]/mL N 20181231 48951-8280_00ccd518-b1e3-4bfa-8d0f-4325744c8e4b 48951-8280 HUMAN OTC DRUG Symphytum Stannum Special Order Symphytum Stannum Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; ARNICA MONTANA; COMFREY ROOT; TIN 3; 3; 3; 17 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8282_5793a1c7-e1e9-4de8-8602-4e1dff760644 48951-8282 HUMAN OTC DRUG Stannum 8 Special Order Stannum 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 8 [hp_X]/mL N 20181231 48951-8283_73e296c4-fd2c-4d46-8fef-3ad0cfda2a72 48951-8283 HUMAN OTC DRUG Piper nigrum e fruct. 6 Special Order Piper nigrum e fruct. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BLACK PEPPER 6 [hp_X]/mL N 20181231 48951-8284_34e6a7b1-b2c1-413e-97de-f04f4cbc2d52 48951-8284 HUMAN OTC DRUG Renes Mesenchyme Special Order Renes Mesenchyme Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BORAGE; CUPRIC ACETATE; BOS TAURUS CONJUNCTIVA; BOS TAURUS LYMPH VESSEL; SUS SCROFA UMBILICAL CORD; BOS TAURUS CARTILAGE; PORK KIDNEY; VISCUM ALBUM FRUITING TOP 6; 6; 8; 8; 8; 8; 8; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8285_d521e249-072b-4f58-a628-bb34052660af 48951-8285 HUMAN OTC DRUG Silicea Belladonna Special Order Silicea Belladonna Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; ATROPA BELLADONNA; COLLOIDAL SILICON DIOXIDE 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8286_f73a9661-bd40-49af-adac-7b5ac32d0264 48951-8286 HUMAN OTC DRUG Stannum 30 Special Order Stannum 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TIN 30 [hp_X]/mL N 20181231 48951-8287_695d152f-3e5f-4c73-be20-726eb1043908 48951-8287 HUMAN OTC DRUG Stibium 6 Special Order Stibium 6 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 6 [hp_X]/g N 20181231 48951-8288_cf5bc938-5f9a-446d-b971-317639c9777f 48951-8288 HUMAN OTC DRUG Prunus spinosa e flor. et summ. 2 Special Order Prunus spinosa e flor. et summ. 2 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE 2 [hp_X]/1 N 20181231 48951-8289_d88903bd-540a-4297-83d9-0694b18273eb 48951-8289 HUMAN OTC DRUG Secale Nicotiana Special Order Secale Nicotiana Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BETULA PUBESCENS LEAF; BETULA PUBESCENS BARK; TOBACCO LEAF; CLAVICEPS PURPUREA SCLEROTIUM; BOS TAURUS ARTERY; LEAD SULFIDE 3; 4; 6; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8292_c3f079e6-1e6c-429e-a994-439709ad1484 48951-8292 HUMAN OTC DRUG Stibium 0.4 Adult Size Special Order Stibium 0.4 Adult Size Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY 3 [hp_X]/g N 20181231 48951-8293_e62111f9-978f-4900-8c7d-b730460db64a 48951-8293 HUMAN OTC DRUG Quartz Oxalis Nicotiana Special Order Quartz Oxalis Nicotiana Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER; TOBACCO LEAF; OXALIS MONTANA LEAF; COLLOIDAL SILICON DIOXIDE 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8294_12500c1b-6480-47e0-bfdb-80e8b97275f1 48951-8294 HUMAN OTC DRUG Plantago e fol. 10 Special Order Plantago e fol. 10 Special Order GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. PLANTAGO MAJOR LEAF 1 [hp_X]/g N 20181231 48951-8295_47b64582-d131-43ea-9e09-6adb001946e4 48951-8295 HUMAN OTC DRUG Pyromorphite 8 Special Order Pyromorphite 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. LEAD DIPHOSPHATE 8 [hp_X]/mL N 20181231 48951-8296_5795f461-0122-0288-e053-2a91aa0aeef4 48951-8296 HUMAN OTC DRUG Pyrargyrite 6 Special Order Pyrargyrite 6 Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SILVER SULFIDE 6 [hp_X]/g N 20181231 48951-8297_439ad147-1c59-4dcc-a9f9-9da517d4b3e3 48951-8297 HUMAN OTC DRUG Rose Copper Viscum Special Order Rose Copper Viscum Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP; FORMICA RUFA; EQUISETUM ARVENSE TOP 1; 8; 19 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8298_e54670bf-27ed-4076-9880-932a9068e8de 48951-8298 HUMAN OTC DRUG Rheuma DKS Special Order Rheuma DKS Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; ARNICA MONTANA FLOWER; COMFREY ROOT; TIN 1; 1; 1; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8300_57959cc6-2e07-4f50-e053-2991aa0a3edd 48951-8300 HUMAN OTC DRUG Silica Skin Support DKS Special Order Silica Skin Support DKS Special Order POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; ANTIMONY; QUERCUS ROBUR WHOLE; BEEF HEART; PORK KIDNEY; MAMMAL LIVER; BOS TAURUS CARTILAGE; SUS SCROFA PANCREAS; SUS SCROFA LUNG 5; 5; 9; 9; 9; 9; 9; 9; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8301_2c41f98e-1ea1-425c-b02e-e8d112ba71da 48951-8301 HUMAN OTC DRUG Sabal Populus Special Order Sabal Populus Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BERBERIS VULGARIS ROOT BARK; POPULUS TREMULA WHOLE; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS WHOLE; MAGNESITE 3; 3; 3; 3; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8302_57e602d5-975f-21ba-e053-2991aa0a1d68 48951-8302 HUMAN OTC DRUG Rhus tox. 1 DKS Special Order Rhus tox. 1 DKS Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TOXICODENDRON PUBESCENS LEAF 2 [hp_X]/g N 20181231 48951-8304_be1329a1-281c-4f69-a0fd-b9e0f71e8f5d 48951-8304 HUMAN OTC DRUG Rosmarinus Lavandula DKS Special Order Rosmarinus Lavandula DKS Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SLOE; BEEF; GOLD; ANTIMONY; CUPRIC CATION; OSTREA EDULIS SHELL; LAVANDULA ANGUSTIFOLIA FLOWER; SEDUM ROSEUM WHOLE; IRON; ROSMARINUS OFFICINALIS FLOWERING TOP; TIN; URTICA DIOICA; SUS SCROFA SKIN; BOS TAURUS OVARY; BOS TAURUS PLACENTA 5; 6; 7; 7; 10; 10; 10; 10; 10; 10; 10; 10; 12; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8306_39bd979f-919f-0554-e054-00144ff8d46c 48951-8306 HUMAN OTC DRUG Ignatia Bryophyllum Ignatia Bryophyllum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; SILVER; KALANCHOE DAIGREMONTIANA LEAF 4; 12; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8307_3d0935dc-cacc-73ec-e054-00144ff88e88 48951-8307 HUMAN OTC DRUG Bismuth Magnesite comp. Bismuth Magnesite comp. POWDER ORAL 20090109 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BISMUTH; ANTIMONY TRISULFIDE; SAFFRON; MAGNESITE; POTASSIUM ACETATE; CORALLIUM RUBRUM EXOSKELETON 3; 6; 6; 3; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8308_3fcb4594-cce5-46ee-e054-00144ff88e88 48951-8308 HUMAN OTC DRUG Arnica e pl. tota 6 Arnica e pl. tota 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA 6 [hp_X]/mL N 20181231 48951-8309_544d7573-213a-577a-e054-00144ff8d46c 48951-8309 HUMAN OTC DRUG Rose Quartz Rose Quartz OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. KALANCHOE DAIGREMONTIANA LEAF; SILICON DIOXIDE 2; 32 [hp_X]/g; [hp_X]/g N 20181231 48951-8310_549c9f43-c3d8-4313-e054-00144ff88e88 48951-8310 HUMAN OTC DRUG Polygonatum Cepa Polygonatum Cepa GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; ECHINACEA ANGUSTIFOLIA; HIRUDIN; POLYGONATUM CYRTONEMA ROOT; VESPA CRABRO; GOLD; BOS TAURUS CARTILAGE; COPPER; SUS SCROFA SKIN; BOS TAURUS PLACENTA; SILICON DIOXIDE; THUJA OCCIDENTALIS WHOLE; SILVER; BARIUM CITRATE; GRAPHITE 2; 2; 4; 4; 6; 8; 8; 8; 8; 8; 8; 8; 12; 12; 17 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8311_549d08f7-da2b-5873-e054-00144ff88e88 48951-8311 HUMAN OTC DRUG Rose Copper Rose Copper OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC CATION 1 [hp_X]/g N 20181231 48951-8312_54c2a982-111b-16bb-e054-00144ff88e88 48951-8312 HUMAN OTC DRUG Rheuma Rheuma OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ONION; ARNICA MONTANA FLOWER; COMFREY ROOT 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-8313_54c2a204-5434-15b5-e054-00144ff88e88 48951-8313 HUMAN OTC DRUG Sabadilla Eucalyptus Sabadilla Eucalyptus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; EUCALYPTUS GUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; ACONITUM NAPELLUS; SCHOENOCAULON OFFICINALE SEED; PHOSPHORUS 3; 3; 3; 4; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-8314_54c6b84f-a1b6-1f18-e054-00144ff8d46c 48951-8314 HUMAN OTC DRUG Primula Onopordon Primula Onopordon PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ONOPORDUM ACANTHIUM FLOWER; PRIMULA VERIS; HYOSCYAMUS NIGER 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8315_5510f584-ce12-411c-e054-00144ff88e88 48951-8315 HUMAN OTC DRUG Pyrite Salvia Pyrite Salvia PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc ANGELICA ARCHANGELICA ROOT; SAGE; HYOSCYAMUS NIGER; SILVER NITRATE 3; 3; 7; 15 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8316_5510f584-ce57-411c-e054-00144ff88e88 48951-8316 HUMAN OTC DRUG Quercus Cinis Quercus Cinis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc WHITE OAK BARK 5 [hp_X]/1 N 20181231 48951-8317_551153e9-cc50-5cb8-e054-00144ff88e88 48951-8317 HUMAN OTC DRUG Silica Silica POWDER ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc EQUISETUM ARVENSE TOP; WHITE OAK BARK; MAMMAL LIVER 5; 9; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-8318_55134586-07b9-2b76-e054-00144ff8d46c 48951-8318 HUMAN OTC DRUG Purple Coneflower Purple Coneflower SPRAY ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc SAGE; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PALLIDA; EUCALYPTUS GLOBULUS LEAF; MERCURIC CYANIDE; SILVER NITRATE; ATROPA BELLADONNA; SILICON DIOXIDE 1; 1; 1; 1; 8; 20; 20; 20 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9000_a3191b8e-22fe-43c9-b2c2-086c1935ee98 48951-9000 HUMAN OTC DRUG Taraxacum e pl tota 1 Special Order Taraxacum e pl tota 1 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TARAXACUM PALUSTRE ROOT 2 [hp_X]/mL N 20181231 48951-9001_56cd4bdb-ef95-48ce-e054-00144ff8d46c 48951-9001 HUMAN OTC DRUG Testes Apis Testes Apis LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROYAL JELLY; SILVER; BOS TAURUS TESTICLE 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9002_5781e813-cb98-18b0-e053-2991aa0a3298 48951-9002 HUMAN OTC DRUG Testes Apis Testes Apis PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. APIS MELLIFERA; SILVER; BOS TAURUS TESTICLE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9003_56cd4bdb-efb3-48ce-e054-00144ff8d46c 48951-9003 HUMAN OTC DRUG Thrombocytes 6 Thrombocytes 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUUS CABALLUS WHOLE 6 [hp_X]/mL N 20181231 48951-9004_56f887a8-3077-6146-e054-00144ff8d46c 48951-9004 HUMAN OTC DRUG Thuja e summ. 6 Special Order Thuja e summ. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THUJA OCCIDENTALIS WHOLE 6 [hp_X]/mL N 20181231 48951-9005_5781e813-cb8a-18b0-e053-2991aa0a3298 48951-9005 HUMAN OTC DRUG Thuja Thymus comp. Thuja Thymus comp. PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; LEVISTICUM OFFICINALE ROOT; SLOE; URTICA DIOICA; DRYOPTERIS FILIX-MAS ROOT; FORMICA RUFA; PTERIDIUM AQUILINUM WHOLE; ASPLENIUM SCOLOPENDRIUM TOP; BOS TAURUS THYMUS; MAMMAL LIVER; OSTREA EDULIS SHELL; SILVER; PORK KIDNEY; THUJA OCCIDENTALIS WHOLE; AMANITA MUSCARIA FRUITING BODY; SILICON DIOXIDE; MERCURY 2; 2; 2; 2; 3; 3; 3; 3; 4; 4; 5; 6; 6; 6; 7; 12; 14 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-9006_56f81b49-79ca-499c-e054-00144ff88e88 48951-9006 HUMAN OTC DRUG Thuja Thymus comp. Thuja Thymus comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUISETUM ARVENSE TOP; LEVISTICUM OFFICINALE ROOT; SLOE; URTICA DIOICA; DRYOPTERIS FILIX-MAS ROOT; FORMICA RUFA; PTERIDIUM AQUILINUM WHOLE; ASPLENIUM SCOLOPENDRIUM TOP; MAMMAL LIVER; BOS TAURUS THYMUS; OSTREA EDULIS SHELL; SILVER; PORK KIDNEY; THUJA OCCIDENTALIS WHOLE; AMANITA MUSCARIA FRUITING BODY; SILICON DIOXIDE; MERCURY 2; 2; 2; 2; 3; 3; 3; 3; 4; 4; 5; 6; 6; 6; 7; 12; 14 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9008_dc32813e-da0f-4333-b6ae-5eb56b6176fa 48951-9008 HUMAN OTC DRUG Thymus Mercurius Thymus Mercurius LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS THYMUS; MERCURY 8; 20 [hp_X]/mL; [hp_X]/mL N 20181231 48951-9009_57825cb5-9e6a-7c48-e053-2a91aa0a3cd7 48951-9009 HUMAN OTC DRUG Thymus Mercurius Thymus Mercurius PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS THYMUS; MERCURY 8; 20 [hp_X]/1; [hp_X]/1 N 20181231 48951-9010_56cd4734-08ff-4843-e054-00144ff8d46c 48951-9010 HUMAN OTC DRUG Thyreoidea Belladonna Thyreoidea Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC SULFATE; OSTREA EDULIS SHELL; THYROID, UNSPECIFIED; ATROPA BELLADONNA; ARSENIC TRIOXIDE 6; 7; 8; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9011_57816443-bbfc-0946-e053-2991aa0a3a10 48951-9011 HUMAN OTC DRUG Thyreoidea Belladonna Thyreoidea Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CUPRIC SULFATE; OSTREA EDULIS SHELL; THYROID, UNSPECIFIED; ATROPA BELLADONNA; ARSENIC TRIOXIDE 6; 7; 8; 15; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9012_6c7536d1-0840-459d-bfbd-ff5a1e971a95 48951-9012 HUMAN OTC DRUG Thyreoidea Ferrum Thyreoidea Ferrum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THYROID, UNSPECIFIED; IRON 6; 12 [hp_X]/mL; [hp_X]/mL N 20181231 48951-9013_57828d70-4eca-b70d-e053-2a91aa0a26da 48951-9013 HUMAN OTC DRUG Thyreoidea Ferrum Thyreoidea Ferrum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THYROID, UNSPECIFIED; IRON 6; 12 [hp_X]/1; [hp_X]/1 N 20181231 48951-9014_e6172647-3051-42e9-b3a2-05c0c9819dbd 48951-9014 HUMAN OTC DRUG Thyreoidea Melissa Thyreoidea Melissa LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FUCUS VESICULOSUS; LYCOPUS VIRGINICUS; MELISSA OFFICINALIS; BOS TAURUS THYMUS; ARSENIC TRIOXIDE; CUPRIC SULFATE; VESPA CRABRO; BOS TAURUS PITUITARY GLAND; THYROID, UNSPECIFIED 3; 3; 3; 5; 6; 6; 6; 20; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9015_57825cb5-9e76-7c48-e053-2a91aa0a3cd7 48951-9015 HUMAN OTC DRUG Thyreoidea Melissa Thyreoidea Melissa PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FUCUS VESICULOSUS; LYCOPUS VIRGINICUS; MELISSA OFFICINALIS; BOS TAURUS THYMUS; ARSENIC TRIOXIDE; CUPRIC SULFATE; VESPA CRABRO; BOS TAURUS PITUITARY GLAND; THYROID, UNSPECIFIED 3; 3; 3; 5; 6; 6; 6; 20; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9016_56cda4aa-06e8-475f-e054-00144ff88e88 48951-9016 HUMAN OTC DRUG Tormentilla Cochlearia Tormentilla Cochlearia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. COCHLEARIA OFFICINALIS FLOWERING TOP; POTENTILLA ERECTA ROOT; ANTIMONY 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9020_56cda727-02aa-475d-e054-00144ff88e88 48951-9020 HUMAN OTC DRUG Triticum Cerebri Triticum Cerebri LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAINSTEM; WHEAT SPROUT 8; 20 [hp_X]/mL; [hp_X]/mL N 20181231 48951-9021_5782a93e-253c-3579-e053-2991aa0aaf2d 48951-9021 HUMAN OTC DRUG Triticum Cerebri Triticum Cerebri PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BRAINSTEM; WHEAT 8; 6 [hp_X]/1; [hp_X]/1 N 20181231 48951-9026_56cda727-02b8-475d-e054-00144ff88e88 48951-9026 HUMAN OTC DRUG Urtica Conchae Special Order Urtica Conchae Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. URTICA URENS; OSTREA EDULIS SHELL; TIN 3; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9027_578203e7-6144-40ad-e053-2991aa0aa3d6 48951-9027 HUMAN OTC DRUG Urtica Conchae Urtica Conchae PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. OSTREA EDULIS SHELL; URTICA URENS; TIN 2; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9028_20d4feec-ea61-4a3b-a712-e3995d2a1fa9 48951-9028 HUMAN OTC DRUG Triticum 3 Triticum 3 PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. WHEAT 3 [hp_X]/1 N 20181231 48951-9029_5e0549a1-4430-4b83-b05a-ea3c85ebfe49 48951-9029 HUMAN OTC DRUG Urtica dioica e pl. tota 1 Urtica dioica e pl. tota 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. URTICA DIOICA 2 [hp_X]/mL N 20181231 48951-9031_afa8779d-2e9b-4bab-b8fd-985bf3e49306 48951-9031 HUMAN OTC DRUG Vagina 11 Special Order Vagina 11 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF 11 1/mL N 20181231 48951-9032_d88e2d65-e8c1-4af7-91ec-661bd5a2b77c 48951-9032 HUMAN OTC DRUG Taraxacum e rad. autumnale 3 Taraxacum e rad. autumnale 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TARAXACUM OFFICINALE ROOT 3 [hp_X]/mL N 20181231 48951-9033_56cda727-02db-475d-e054-00144ff88e88 48951-9033 HUMAN OTC DRUG Valeriana Conchae Special Order Valeriana Conchae Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VALERIAN; OSTREA EDULIS SHELL; PHOSPHORUS; SULFUR 3; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9034_578203e7-6138-40ad-e053-2991aa0aa3d6 48951-9034 HUMAN OTC DRUG Valeriana Conchae Valeriana Conchae PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VALERIAN; OSTREA EDULIS SHELL; PHOSPHORUS; SULFUR 3; 6; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9036_56cda727-02e9-475d-e054-00144ff88e88 48951-9036 HUMAN OTC DRUG Valeriana e rad. 3 Valeriana e rad. 3 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VALERIAN 3 [hp_X]/mL N 20181231 48951-9037_56cde38c-99e5-645a-e054-00144ff8d46c 48951-9037 HUMAN OTC DRUG Veratrum Chamomilla Veratrum Chamomilla LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; MATRICARIA RECUTITA; VERATRUM ALBUM ROOT; CUPRIC SULFATE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; BOS TAURUS NERVE; PRUNUS SPINOSA FLOWER BUD; ANTIMONY 3; 3; 4; 6; 6; 6; 6; 6 [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9038_5783091e-d360-342d-e053-2991aa0a57b3 48951-9038 HUMAN OTC DRUG Veratrum Chamomilla Veratrum Chamomilla PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; MATRICARIA RECUTITA; VERATRUM ALBUM ROOT; CUPRIC SULFATE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; BOS TAURUS NERVE; SLOE; ANTIMONY 3; 3; 4; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9039_62f7f7d7-f3f9-446b-abd1-cb229f4ac9bc 48951-9039 HUMAN OTC DRUG Vertebra thoracica 6 Special Order Vertebra thoracica 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE 6 [hp_X]/mL N 20181231 48951-9040_c8ee3870-82ee-476f-905e-78905268b147 48951-9040 HUMAN OTC DRUG Vertebra lumbalis 6 Vertebra lumbalis 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS BONE 6 [hp_X]/mL N 20181231 48951-9041_56ce2d24-d609-72c1-e054-00144ff8d46c 48951-9041 HUMAN OTC DRUG Vesica fellea Ferrum 17/20 Special Order Vesica fellea Ferrum 17/20 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA ANGUSTIFOLIA; BOS TAURUS GALLBLADDER; IRON; SILVER 3; 17; 20; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9042_cb5d84f9-fd9c-4bcc-af51-38da28c8d431 48951-9042 HUMAN OTC DRUG Vesica fellea Ferrum 17/20 Special Order Vesica fellea Ferrum 17/20 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS GALLBLADDER; IRON 17; 20 [hp_X]/1; [hp_X]/1 N 20181231 48951-9043_d91b72de-797c-4d6e-821b-c125beb51c73 48951-9043 HUMAN OTC DRUG Vesica fellea Ferrum 6/8 Special Order Vesica fellea Ferrum 6/8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. CHELIDONIUM MAJUS ROOT; TURMERIC; BOS TAURUS GALLBLADDER; IRON 3; 3; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9044_51f51206-c728-4459-b87b-ca7589e8221e 48951-9044 HUMAN OTC DRUG Vesica fellea 6 Special Order Vesica fellea 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS GALLBLADDER 6 [hp_X]/mL N 20181231 48951-9045_94c445d6-fdf5-4cb7-af95-0faeab9e8c0b 48951-9045 HUMAN OTC DRUG Vespa crabro ex animale 6 Special Order Vespa crabro ex animale 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VESPA CRABRO 6 [hp_X]/mL N 20181231 48951-9047_f4ae142d-5d2d-495d-9609-4d28ca36bef7 48951-9047 HUMAN OTC DRUG Viola comp. Special Order Viola comp. Special Order GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VIOLA ODORATA FLOWERING TOP; URTICA DIOICA; SAMBUCUS NIGRA FLOWERING TOP; ANTIMONY 1; 1; 2; 5 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-9048_57d19658-14ce-45ad-e053-2a91aa0a8483 48951-9048 HUMAN OTC DRUG Viscum 1 Viscum 1 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/g N 20181231 48951-9049_57d19658-14b1-45ad-e053-2a91aa0a8483 48951-9049 HUMAN OTC DRUG Viscum 3 Viscum 3 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/g N 20181231 48951-9050_57d19658-14bf-45ad-e053-2a91aa0a8483 48951-9050 HUMAN OTC DRUG Viscum 10 Viscum 10 CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/g N 20181231 48951-9055_03df7eae-4dff-448c-bf44-fbabb890c66b 48951-9055 HUMAN OTC DRUG Viscum Abietis e pl. tota 4 Special Order Viscum Abietis e pl. tota 4 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 4 [hp_X]/mL N 20181231 48951-9060_3a791d03-a35b-44d4-b3cc-9058656664a9 48951-9060 HUMAN OTC DRUG Viscum album 1 Special Order Viscum album 1 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9061_154ed979-4aad-45ce-8e95-027cfde86174 48951-9061 HUMAN OTC DRUG Viscum Belladonna Viscum Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP; ARNICA MONTANA; GOLD; ATROPA BELLADONNA 4; 6; 10; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9062_5783165e-65e1-5123-e053-2a91aa0a6fa6 48951-9062 HUMAN OTC DRUG Viscum Belladonna Viscum Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP; ARNICA MONTANA; GOLD; ATROPA BELLADONNA 4; 6; 10; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9072_556b716a-54ac-4eef-8246-756aba5caf69 48951-9072 HUMAN OTC DRUG Viscum Crataegus Viscum Crataegus LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; VISCUM ALBUM FRUITING TOP; GOLD; EQUISETUM ARVENSE TOP 3; 4; 10; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9073_5783165e-65d4-5123-e053-2a91aa0a6fa6 48951-9073 HUMAN OTC DRUG Viscum Crataegus Viscum Crataegus PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. HAWTHORN LEAF WITH FLOWER; VISCUM ALBUM FRUITING TOP; GOLD; EQUISETUM ARVENSE TOP 3; 4; 10; 17 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9074_06140d47-52dd-4e19-a2bd-c646c766c1d4 48951-9074 HUMAN OTC DRUG Viscum Echinacea Viscum Echinacea LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; VISCUM ALBUM FRUITING TOP; FORMICA RUFA 2; 2; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9075_5782f9da-0852-1cce-e053-2a91aa0a8882 48951-9075 HUMAN OTC DRUG Viscum Echinacea Viscum Echinacea PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ECHINACEA, UNSPECIFIED; VISCUM ALBUM FRUITING TOP; FORMICA RUFA 2; 2; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9076_a31114f0-5759-4c15-bbb4-d0ca6e0bd750 48951-9076 HUMAN OTC DRUG Viscum Mali (I) 0.01mg Viscum Mali (I) 0.01mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 5 [hp_X]/mL N 20181231 48951-9077_66d8be3f-4b54-4cd1-b0ce-928187cd052a 48951-9077 HUMAN OTC DRUG Viscum Mali (I) 0.1mg Viscum Mali (I) 0.1mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 4 [hp_X]/mL N 20181231 48951-9078_a4a8697d-df47-488c-8365-a2228e960639 48951-9078 HUMAN OTC DRUG Viscum Mali (I) 1mg Viscum Mali (I) 1mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 3 [hp_X]/mL N 20181231 48951-9079_f75c8d77-3075-407f-a23c-d7bb7789b8a1 48951-9079 HUMAN OTC DRUG Viscum Mali (I) 2mg Viscum Mali (I) 2mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9080_493a2654-8488-40fc-9ef3-ed0a78314e7d 48951-9080 HUMAN OTC DRUG Viscum (I) Mali Series 0 Viscum (I) Mali Series 0 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 3 [hp_X]/mL N 20181231 48951-9081_bbae5818-33dd-48f5-a6df-f120f358f522 48951-9081 HUMAN OTC DRUG Viscum Quercus (I) 1mg Viscum Quercus (I) 1mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 3 [hp_X]/mL N 20181231 48951-9082_7bd78c77-e5ec-4f6c-bc2f-aa2169342f10 48951-9082 HUMAN OTC DRUG Viscum Quercus (I) 2mg Viscum Quercus (I) 2mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9083_8b4ea9ed-b277-4f07-9ff2-07c9ee74242b 48951-9083 HUMAN OTC DRUG Viscum (I) Quercus Series 0 Viscum (I) Quercus Series 0 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 3 [hp_X]/mL N 20181231 48951-9084_d0019c84-8158-469a-a704-212cf4c39e53 48951-9084 HUMAN OTC DRUG Viscum Mali 4 Viscum Mali 4 SPRAY NASAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 4 [hp_X]/mL N 20181231 48951-9085_00f5879b-67da-4510-abd1-b9b7fb061558 48951-9085 HUMAN OTC DRUG Viscum Mali e pl. tota 5% Viscum Mali e pl. tota 5% PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/1 N 20181231 48951-9091_2293c306-a538-4eba-95f9-5e59e8ef070c 48951-9091 HUMAN OTC DRUG Viscum Mali e pl. tota 30 Viscum Mali e pl. tota 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 30 [hp_X]/mL N 20181231 48951-9092_3a81f2e0-e230-48cc-b556-96b7e25189d0 48951-9092 HUMAN OTC DRUG Viscum Mali e pl. tota 4 Viscum Mali e pl. tota 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 4 [hp_X]/mL N 20181231 48951-9093_961b5c34-ef91-409f-9463-a208842a02d0 48951-9093 HUMAN OTC DRUG Viscum Mali e pl. tota 6 Viscum Mali e pl. tota 6 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 6 [hp_X]/mL N 20181231 48951-9105_b43dba99-9757-4026-a486-7dbd9f5c7625 48951-9105 HUMAN OTC DRUG Viscum Pini e pl. tota 4 Viscum Pini e pl. tota 4 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 4 [hp_X]/mL N 20181231 48951-9122_09e92815-3288-4430-bb72-78c33f2bccdd 48951-9122 HUMAN OTC DRUG Viscum comp. Viscum comp. LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP; ANTIMONY; PHOSPHORUS 4; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9144_7fadc775-2a81-4132-a72f-47dc0271c483 48951-9144 HUMAN OTC DRUG Viscum Stannum Viscum Stannum LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; VISCUM ALBUM FRUITING TOP; MAMMAL LIVER; BEEF; TIN 3; 3; 6; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9145_57831a51-a349-53c8-e053-2a91aa0a3729 48951-9145 HUMAN OTC DRUG Viscum Stannum Viscum Stannum PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BRYONIA ALBA ROOT; VISCUM ALBUM FRUITING TOP; MAMMAL LIVER; BEEF; TIN 3; 3; 6; 8; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9157_57e7293b-2195-760f-e053-2991aa0ad459 48951-9157 HUMAN OTC DRUG Vitamin E Adult Size Special Order Vitamin E Adult Size Special Order SUPPOSITORY RECTAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. .ALPHA.-TOCOPHEROL 200 [iU]/g N 20181231 48951-9158_549c7037-9574-068b-e054-00144ff8d46c 48951-9158 HUMAN OTC DRUG Vitis Stibium Vitis Stibium TABLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. FRAGARIA VESCA WHOLE; VITIS VINIFERA LEAF; CALCIUM CATION; ANTIMONY 1; 1; 3; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9160_57831a51-a33b-53c8-e053-2a91aa0a3729 48951-9160 HUMAN OTC DRUG Willow Fern Willow Fern PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. DRYOPTERIS FILIX-MAS ROOT; PTERIDIUM AQUILINUM WHOLE; SALIX PURPUREA BARK; WILLOW BARK; SALIX ALBA FLOWER; ASPLENIUM SCOLOPENDRIUM TOP 3; 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9166_553b1a0a-f1fe-45e2-e054-00144ff88e88 48951-9166 HUMAN OTC DRUG Aconitum Belladonna Aconitum Belladonna LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ATROPA BELLADONNA; APIS MELLIFERA 4; 5 [hp_X]/mL; [hp_X]/mL N 20181231 48951-9167_57090d1c-222c-23f2-e054-00144ff8d46c 48951-9167 HUMAN OTC DRUG Aconitum Belladonna Aconitum Belladonna PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9170_56dfe635-8976-6b22-e054-00144ff8d46c 48951-9170 HUMAN OTC DRUG Aconitum Bryonia Aconitum Bryonia LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT 3; 3 [hp_X]/mL; [hp_X]/mL N 20181231 48951-9171_553b4043-7399-2f1e-e054-00144ff8d46c 48951-9171 HUMAN OTC DRUG Aconitum e tub. 30 Aconitum e tub. 30 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ACONITUM NAPELLUS 30 [hp_X]/mL N 20181231 48951-9175_57d2549e-fb23-1791-e053-2a91aa0a7f63 48951-9175 HUMAN OTC DRUG Jewelweed 20 Jewelweed 20 GEL TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. IMPATIENS BALSAMINA FLOWER 1 [hp_X]/g N 20181231 48951-9176_877f70fd-9fea-43d8-9614-8669e7f05a47 48951-9176 HUMAN OTC DRUG Vesica urinaria 8 Special Order Vesica urinaria 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA URINARY BLADDER 8 [hp_X]/mL N 20181231 48951-9177_549c56d2-ef60-4946-e054-00144ff88e88 48951-9177 HUMAN OTC DRUG Urtica Betula Special Order Urtica Betula Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. URTICA DIOICA; BETULA PUBESCENS LEAF; SILVER SULFIDE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; FERROSOFERRIC PHOSPHATE; BOS TAURUS BONE MARROW 3; 4; 6; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9178_3d79ddaa-931a-47bf-a65b-7739a89b9cb4 48951-9178 HUMAN OTC DRUG Tourmaline Formica comp. Special Order Tourmaline Formica comp. Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ANTIMONY TRISULFIDE; BEEF HEART; FORMICA RUFA; SCHORL TOURMALINE 6; 6; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9179_2796d462-cd7a-4461-8bed-fe83837c4654 48951-9179 HUMAN OTC DRUG Thuja e summ. 6 Special Order Thuja e summ. 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THUJA OCCIDENTALIS WHOLE 6 [hp_X]/mL N 20181231 48951-9180_f5ad67a7-3d89-4839-bb80-af8afe9e1e99 48951-9180 HUMAN OTC DRUG Valvula aortae 6 Special Order Valvula aortae 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BEEF HEART 6 [hp_X]/mL N 20181231 48951-9181_56cde38c-99f3-645a-e054-00144ff8d46c 48951-9181 HUMAN OTC DRUG Vespa crabro 15 Special Order Vespa crabro 15 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VESPA CRABRO 15 [hp_X]/mL N 20181231 48951-9182_275296f0-f5e6-4095-9c39-ebab173d1e96 48951-9182 HUMAN OTC DRUG Thrombocytes 30 Special Order Thrombocytes 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. EQUUS CABALLUS WHOLE 30 [hp_X]/mL N 20181231 48951-9183_9d2b559b-fc00-484a-9b1a-07f29f0b0723 48951-9183 HUMAN OTC DRUG Tourmaline 30 Special Order Tourmaline 30 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SCHORL TOURMALINE 30 [hp_X]/mL N 20181231 48951-9184_56f84f76-90b8-4eee-e054-00144ff8d46c 48951-9184 HUMAN OTC DRUG Thyreoidea Ferrum Special Order Thyreoidea Ferrum Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THYROID, UNSPECIFIED; IRON 6; 12 [hp_X]/mL; [hp_X]/mL N 20181231 48951-9185_56cd4428-7b36-22a1-e054-00144ff8d46c 48951-9185 HUMAN OTC DRUG Taraxacum e rad. vernale 3 Special Order Taraxacum e rad. vernale 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TARAXACUM OFFICINALE ROOT 3 [hp_X]/mL N 20181231 48951-9186_65a8c1b8-b2e3-49b0-8a2f-56e0eda78fbd 48951-9186 HUMAN OTC DRUG Viscum Quercus 3 Special Order Viscum Quercus 3 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 3 [hp_X]/1 N 20181231 48951-9187_c172009e-e8f9-494f-a694-c1ee6630871e 48951-9187 HUMAN OTC DRUG Testes Arnica Special Order Testes Arnica Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ARNICA MONTANA; BOS TAURUS TESTICLE 6; 6 [hp_X]/mL; [hp_X]/mL N 20181231 48951-9188_5782a93e-2531-3579-e053-2991aa0aaf2d 48951-9188 HUMAN OTC DRUG Tuba auditiva 6 Special Order Tuba auditiva 6 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA EAR 6 [hp_X]/1 N 20181231 48951-9189_abcb9077-8e7f-47fb-b34c-f39de9cc54a8 48951-9189 HUMAN OTC DRUG Urtica dioica ex herba Essence Special Order Urtica dioica ex herba Essence Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. URTICA DIOICA LEAF 1 [hp_X]/mL N 20181231 48951-9190_cc310c8a-b77a-4c67-9adc-1d10399df1d5 48951-9190 HUMAN OTC DRUG Thalamus 8 Special Order Thalamus 8 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. SUS SCROFA THALAMUS 8 [hp_X]/mL N 20181231 48951-9192_f3a32667-c86a-4827-9639-31f6ad16ca98 48951-9192 HUMAN OTC DRUG Viscum 30 Special Order Viscum 30 Special Order CREAM TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/g N 20181231 48951-9193_9292c3b9-9a9e-48cb-a6da-5b10213e6527 48951-9193 HUMAN OTC DRUG Vesica fellea Ferrum 6/8 Special Order Vesica fellea Ferrum 6/8 Special Order PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. BOS TAURUS GALLBLADDER; IRON 6; 8 [hp_X]/1; [hp_X]/1 N 20181231 48951-9194_0a186550-e1b9-416a-ac18-0727150207c4 48951-9194 HUMAN OTC DRUG Viola Chamomilla Special Order Viola Chamomilla Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. MATRICARIA RECUTITA; VIOLA ODORATA FLOWERING TOP; ATROPA BELLADONNA; MERCURIC IODIDE; FERROSOFERRIC PHOSPHATE 3; 3; 7; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 48951-9195_06b1632a-8c15-4414-992f-8f2be907c9a2 48951-9195 HUMAN OTC DRUG Taraxacum e pl. tota 2 Special Order Taraxacum e pl. tota 2 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. TARAXACUM PALUSTRE ROOT 2 [hp_X]/mL N 20181231 48951-9196_2e470845-d52d-4680-a114-0d4b7dd4706b 48951-9196 HUMAN OTC DRUG Testes Apis Special Order Testes Apis Special Order CAPSULE ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROYAL JELLY; SILVER; BOS TAURUS TESTICLE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9197_0185ffe9-1e8f-4693-92c5-abf04a78ba22 48951-9197 HUMAN OTC DRUG Thuja e summ. 3 Special Order Thuja e summ. 3 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. THUJA OCCIDENTALIS WHOLE 3 [hp_X]/mL N 20181231 48951-9198_dbc93a8d-fb42-47ca-b2e4-af9d26d6be42 48951-9198 HUMAN OTC DRUG Viscum Quercus 6 Special Order Viscum Quercus 6 Special Order LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 6 [hp_X]/mL N 20181231 48951-9199_c4d8d5a3-5004-423c-9a58-c9964a325464 48951-9199 HUMAN OTC DRUG Viscum Mali 12.5mg Viscum Mali 12.5mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9200_38b9c3d0-8618-48eb-b1ac-4cc4a4c5d295 48951-9200 HUMAN OTC DRUG Viscum Abietis 12.5mg Viscum Abietis 12.5mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9201_9078fff6-7df9-477e-832c-af1922b42455 48951-9201 HUMAN OTC DRUG Viscum Quercus (I) 0.1mg Viscum Quercus (I) 0.1mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 4 [hp_Q]/mL N 20181231 48951-9202_0ae53889-db3b-4763-9495-fca39f30f1b5 48951-9202 HUMAN OTC DRUG Viscum Quercus (I) 0.01mg Viscum Quercus (I) 0.01mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 5 [hp_X]/mL N 20181231 48951-9203_02a1769b-5ae0-44a4-94c2-93a129f14bab 48951-9203 HUMAN OTC DRUG Viscum Pini (I) 1mg Viscum Pini (I) 1mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 3 [hp_X]/mL N 20181231 48951-9204_6de6fc2b-74b2-46ee-8e81-acc7ec517ab4 48951-9204 HUMAN OTC DRUG Viscum Pini (I) 2mg Viscum Pini (I) 2mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9205_54236151-37cc-0b5a-e054-00144ff88e88 48951-9205 HUMAN OTC DRUG Viscum Abietis Series 1 Viscum Abietis Series 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 6 [hp_X]/mL N 20181231 48951-9206_54238b31-ee96-0065-e054-00144ff88e88 48951-9206 HUMAN OTC DRUG Viscum Abietis Series 2 Viscum Abietis Series 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9207_54243432-477f-2682-e054-00144ff88e88 48951-9207 HUMAN OTC DRUG Viscum Crataegi Series 1 Viscum Crataegi Series 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 6 [hp_X]/mL N 20181231 48951-9208_542385ba-6f85-06fe-e054-00144ff8d46c 48951-9208 HUMAN OTC DRUG Viscum Crataegi Series 2 Viscum Crataegi Series 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9209_5423c0da-eb06-20cd-e054-00144ff8d46c 48951-9209 HUMAN OTC DRUG Viscum Mali Series 1 Viscum Mali Series 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 6 [hp_X]/mL N 20181231 48951-9210_5423d703-f335-1b9d-e054-00144ff88e88 48951-9210 HUMAN OTC DRUG Viscum Mali Series 2 Viscum Mali Series 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9211_5421382e-2636-3af2-e054-00144ff88e88 48951-9211 HUMAN OTC DRUG Viscum Pini Series 1 Viscum Pini Series 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 6 [hp_X]/mL N 20181231 48951-9212_5421a0f2-c1d3-3038-e054-00144ff8d46c 48951-9212 HUMAN OTC DRUG Viscum Pini Series 2 Viscum Pini Series 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9213_5423c0da-eb19-20cd-e054-00144ff8d46c 48951-9213 HUMAN OTC DRUG Viscum Populi Series 1 Viscum Populi Series 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 6 [hp_X]/mL N 20181231 48951-9214_54241254-1da2-346a-e054-00144ff8d46c 48951-9214 HUMAN OTC DRUG Viscum Populi Series 2 Viscum Populi Series 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9215_542385ba-6f6a-06fe-e054-00144ff8d46c 48951-9215 HUMAN OTC DRUG Viscum Quercus Series 1 Viscum Quercus Series 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 6 [hp_X]/mL N 20181231 48951-9216_5423c0da-eafa-20cd-e054-00144ff8d46c 48951-9216 HUMAN OTC DRUG Viscum Quercus Series 2 Viscum Quercus Series 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9217_542462c0-15af-40f2-e054-00144ff8d46c 48951-9217 HUMAN OTC DRUG Viscum Salicis Series 1 Viscum Salicis Series 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 6 [hp_X]/mL N 20181231 48951-9218_5424c65b-e7fe-3de2-e054-00144ff88e88 48951-9218 HUMAN OTC DRUG Viscum Salicis Series 2 Viscum Salicis Series 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9219_5423a39f-09a3-154a-e054-00144ff88e88 48951-9219 HUMAN OTC DRUG Viscum Tiliae Series 1 Viscum Tiliae Series 1 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 6 [hp_X]/mL N 20181231 48951-9220_5423d703-f325-1b9d-e054-00144ff88e88 48951-9220 HUMAN OTC DRUG Viscum Tiliae Series 2 Viscum Tiliae Series 2 LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9239_643e7cf8-0f33-446d-bd20-bf210462b4e3 48951-9239 HUMAN OTC DRUG Vespa crabro DKS Special Order Vespa crabro DKS Special Order OINTMENT TOPICAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. ROYAL JELLY; TIN; ANTIMONY; VESPA CRABRO; BOS TAURUS PLACENTA; URTICA DIOICA; EQUISETUM ARVENSE TOP; VISCUM ALBUM FRUITING TOP; SEDUM ROSEUM WHOLE; GOLD; COPPER 6; 6; 6; 6; 8; 8; 8; 8; 10; 10; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 48951-9240_542561bc-c6b4-537a-e054-00144ff88e88 48951-9240 HUMAN OTC DRUG Viscum Abietis 10mg Viscum Abietis 10mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9241_542561bc-c67e-537a-e054-00144ff88e88 48951-9241 HUMAN OTC DRUG Viscum Abietis 20mg Viscum Abietis 20mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9242_4b6ef268-1972-04f6-e054-00144ff88e88 48951-9242 HUMAN OTC DRUG Viscum Abietis Series 1 7ml Viscum Abietis Series 1 7ml LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9243_4d9f65f2-7a2b-67e4-e054-00144ff8d46c 48951-9243 HUMAN OTC DRUG Viscum Mali 10mg Viscum Mali 10mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9244_4d9f9fe4-ed88-4418-e054-00144ff88e88 48951-9244 HUMAN OTC DRUG Viscum Mali 1mg Viscum Mali 1mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 3 [hp_X]/mL N 20181231 48951-9245_4d9feb6b-5bea-0dc4-e054-00144ff8d46c 48951-9245 HUMAN OTC DRUG Viscum Mali 20mg Viscum Mali 20mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9246_4da00868-1e28-1499-e054-00144ff8d46c 48951-9246 HUMAN OTC DRUG Viscum Mali 30mg Viscum Mali 30mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9247_4d9fd880-aa37-0aea-e054-00144ff8d46c 48951-9247 HUMAN OTC DRUG Viscum Mali 5mg Viscum Mali 5mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9248_4ea55c2d-9d72-21fe-e054-00144ff8d46c 48951-9248 HUMAN OTC DRUG Viscum Mali Series 1 7ml Viscum Mali Series 1 7ml LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9249_4ea52119-aa5e-185e-e054-00144ff8d46c 48951-9249 HUMAN OTC DRUG Viscum Mali Series 2 7ml Viscum Mali Series 2 7ml LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9250_4fe19a27-ab28-72ce-e054-00144ff8d46c 48951-9250 HUMAN OTC DRUG Viscum Mali Series 3 7ml Viscum Mali Series 3 7ml LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9251_4fe19908-c36a-5c8e-e054-00144ff88e88 48951-9251 HUMAN OTC DRUG Viscum Pini 10mg Viscum Pini 10mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9252_4fe19a27-ab4c-72ce-e054-00144ff8d46c 48951-9252 HUMAN OTC DRUG Viscum Pini 1mg Viscum Pini 1mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 3 [hp_X]/mL N 20181231 48951-9253_4fe1eed3-bc1d-09d7-e054-00144ff8d46c 48951-9253 HUMAN OTC DRUG Viscum Pini 20mg Viscum Pini 20mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9254_4fe230be-ec70-12c2-e054-00144ff8d46c 48951-9254 HUMAN OTC DRUG Viscum Pini 30mg Viscum Pini 30mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9256_4fe2876d-49fb-08bb-e054-00144ff88e88 48951-9256 HUMAN OTC DRUG Viscum Pini Series 1 7ml Viscum Pini Series 1 7ml LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9257_4fe2876d-4a0e-08bb-e054-00144ff88e88 48951-9257 HUMAN OTC DRUG Viscum Pini Series 2 7ml Viscum Pini Series 2 7ml LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9258_541030f1-c34a-730b-e054-00144ff8d46c 48951-9258 HUMAN OTC DRUG Viscum Pini Series 3 7ml Viscum Pini Series 3 7ml LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9259_54255033-c290-042b-e054-00144ff8d46c 48951-9259 HUMAN OTC DRUG Viscum Abietis 1mg Viscum Abietis 1mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 3 [hp_X]/mL N 20181231 48951-9260_54255033-c282-042b-e054-00144ff8d46c 48951-9260 HUMAN OTC DRUG Viscum Abietis 5mg Viscum Abietis 5mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9261_542540dc-49e8-501d-e054-00144ff88e88 48951-9261 HUMAN OTC DRUG Viscum Abietis 30mg Viscum Abietis 30mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9262_542540dc-49f2-501d-e054-00144ff88e88 48951-9262 HUMAN OTC DRUG Viscum Abietis 50mg Viscum Abietis 50mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9263_54341164-caa8-0297-e054-00144ff8d46c 48951-9263 HUMAN OTC DRUG Viscum Abietis 100mg Viscum Abietis 100mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9264_4b6ef268-197f-04f6-e054-00144ff88e88 48951-9264 HUMAN OTC DRUG Viscum Abietis Series 2 7ml Viscum Abietis Series 2 7ml LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9265_4d9edeb1-59da-380c-e054-00144ff8d46c 48951-9265 HUMAN OTC DRUG Viscum Abietis Series 3 7ml Viscum Abietis Series 3 7ml LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9266_4d9f525d-a62e-64aa-e054-00144ff8d46c 48951-9266 HUMAN OTC DRUG Viscum Abietis Series 4 7ml Viscum Abietis Series 4 7ml LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9267_4ea4acf8-1848-57c0-e054-00144ff88e88 48951-9267 HUMAN OTC DRUG Viscum Mali 50mg Viscum Mali 50mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9268_4ea517e7-15bf-1749-e054-00144ff8d46c 48951-9268 HUMAN OTC DRUG Viscum Mali 100mg Viscum Mali 100mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9269_4fe17bf6-cd25-6597-e054-00144ff8d46c 48951-9269 HUMAN OTC DRUG Viscum Mali Series 4 7ml Viscum Mali Series 4 7ml LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9270_4fe251d0-3601-1b80-e054-00144ff8d46c 48951-9270 HUMAN OTC DRUG Viscum Pini 50mg Viscum Pini 50mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9271_4fe24a01-ed4a-019d-e054-00144ff88e88 48951-9271 HUMAN OTC DRUG Viscum Pini 100mg Viscum Pini 100mg LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9272_4fe2cf36-6241-12ef-e054-00144ff88e88 48951-9272 HUMAN OTC DRUG Viscum Pini Series 4 7ml Viscum Pini Series 4 7ml LIQUID ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9273_543479f4-23b1-6a80-e054-00144ff88e88 48951-9273 HUMAN OTC DRUG Viscum Abietis 100mg Viscum Abietis 100mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9274_5434dea2-c3bb-0324-e054-00144ff88e88 48951-9274 HUMAN OTC DRUG Viscum Abietis 50mg Viscum Abietis 50mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9275_543515c9-9c64-1948-e054-00144ff88e88 48951-9275 HUMAN OTC DRUG Viscum Mali 100mg Viscum Mali 100mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9276_543515c9-9c75-1948-e054-00144ff88e88 48951-9276 HUMAN OTC DRUG Viscum Mali 50mg Viscum Mali 50mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 1 [hp_X]/mL N 20181231 48951-9277_543515c9-9c83-1948-e054-00144ff88e88 48951-9277 HUMAN OTC DRUG Viscum Pini 100mg Viscum Pini 100mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9278_54351529-07c0-0624-e054-00144ff88e88 48951-9278 HUMAN OTC DRUG Viscum Pini 50mg Viscum Pini 50mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9279_55118ae9-a1a8-5e1c-e054-00144ff8d46c 48951-9279 HUMAN OTC DRUG Wild Yam Ginger Wild Yam Ginger SPRAY NASAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc DIOSCOREA VILLOSA ROOT; GINGER 2; 2 [hp_X]/1; [hp_X]/1 N 20181231 48951-9280_55118d3e-11e4-6345-e054-00144ff88e88 48951-9280 HUMAN OTC DRUG Travel Remedy Travel Remedy PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc PRIMULA VERIS; ONOPORDUM; HYOSCYAMUS NIGER; ANTIMONY; GOLD; ARNICA MONTANA; BELLIS PERENNIS; MATRICARIA RECUTITA; IPECAC; LYCOPODIUM CLAVATUM SPORE 3; 3; 4; 8; 10; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9281_5513b81f-160c-4d14-e054-00144ff8d46c 48951-9281 HUMAN OTC DRUG Tormentilla Cochlearia Tormentilla Cochlearia PELLET ORAL 20090901 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc HORSERADISH; ACHILLEA MILLEFOLIUM; ANTIMONY 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 48951-9282_5425d7f4-8dfa-19cc-e054-00144ff8d46c 48951-9282 HUMAN OTC DRUG Viscum Pini 5mg Viscum Pini 5mg LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc. VISCUM ALBUM FRUITING TOP 2 [hp_X]/mL N 20181231 48951-9998_fa4e73f6-1039-11df-8a39-0800200c9a66 48951-9998 HUMAN OTC DRUG Saline SODIUM CHLORIDE SOLUTION/ DROPS ORAL 20100201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc SODIUM CHLORIDE 1 [hp_X]/1 N 20181231 48951-9999_b5cb3250-1038-11df-8a39-0800200c9a66 48951-9999 HUMAN OTC DRUG Sucrose SUCROSE PELLET ORAL 20100201 UNAPPROVED HOMEOPATHIC Uriel Pharmacy Inc SUCROSE 1 [hp_X]/1 N 20181231 48964-112_bb27c349-d154-4974-8dce-4c79ebea9659 48964-112 HUMAN OTC DRUG nexafed pseudoephedrine HCL TABLET ORAL 20121210 OTC MONOGRAPH FINAL part341 Acura Pharmaceuticals, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 E 20171231 49035-000_49720dcf-7e48-4372-8e43-94c25c95df61 49035-000 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20130318 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 49035-001_165f3d5f-f2bb-43aa-9d00-7abc23d34aea 49035-001 HUMAN OTC DRUG Diaper Rash Zinc oxide CREAM TOPICAL 19940131 OTC MONOGRAPH FINAL part347 Wal-Mart Stores Inc ZINC OXIDE 130 mg/g N 20181231 49035-003_4ca98452-1c8b-4612-86c6-fc1545d920e9 49035-003 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20050620 OTC MONOGRAPH FINAL part333D Wal-Mart Stores Inc SALICYLIC ACID 19.8 mg/g N 20181231 49035-004_14931b92-098e-4805-be91-8c1d67659ebb 49035-004 HUMAN OTC DRUG Anticavity Rinse Sodium Fluoride MOUTHWASH ORAL 20040406 OTC MONOGRAPH FINAL part355 Wal Mart SODIUM FLUORIDE .2 mg/mL N 20181231 49035-005_211a112e-1891-4942-9f01-dce491c8c53e 49035-005 HUMAN OTC DRUG Stool Softener Gentle Relief DOCUSATE SODIUM CAPSULE ORAL 20110331 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 100 mg/1 N 20181231 49035-006_917cfb04-7e7b-4041-8b71-eecc4edbfaaa 49035-006 HUMAN OTC DRUG Hair Regrowth Treatment for Women Minoxidil SOLUTION TOPICAL 20040204 20190228 ANDA ANDA074588 Wal-Mart Stores Inc MINOXIDIL 20 mg/mL N 20181231 49035-007_74b84b17-ee7d-48ff-b0c1-6a8a3b0a5871 49035-007 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090522 20180330 OTC MONOGRAPH NOT FINAL part333A EQUATE (Walmart Stores, Inc.) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 49035-008_7b655986-1a3b-4e1b-8bae-cdee81bebdf5 49035-008 HUMAN OTC DRUG Wintergreen Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090506 20180228 OTC MONOGRAPH NOT FINAL part333A EQUATE (Walmart Stores, Inc.) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 49035-009_22ddb82e-72f2-4292-b222-3b708092d2d5 49035-009 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20050208 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc COAL TAR 25 mg/mL N 20181231 49035-010_3866a4ec-c51f-d62f-7308-da420c0dd0d2 49035-010 HUMAN OTC DRUG Allergy Relief Cetirizine Hydrochloride Tablets TABLET, FILM COATED ORAL 20110208 ANDA ANDA078343 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 49035-011_731ff711-ba7f-4cca-a83c-86e3c2352a52 49035-011 HUMAN OTC DRUG Hydrocortisone Hydrocortisone Continuous Spray AEROSOL, SPRAY TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc HYDROCORTISONE 1.13 g/113g N 20181231 49035-012_316968e1-7716-4caa-e054-00144ff8d46c 49035-012 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20160426 OTC MONOGRAPH FINAL part341 Walmart Stores Inc. MENTHOL 5.8 mg/1 N 20181231 49035-012_417049c6-5842-2a1c-e054-00144ff88e88 49035-012 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20160428 OTC MONOGRAPH FINAL part341 Walmart Stores Inc. MENTHOL 5.8 mg/1 N 20181231 49035-013_c898f1f8-b066-4ce0-8e18-f76a83a81d85 49035-013 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130930 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 49035-014_81667123-5c31-41b0-8a47-2ea39967f0fc 49035-014 HUMAN OTC DRUG Equate Antibacterial Foaming Hand Spring Showers Benzalkonium Chloride LIQUID TOPICAL 20170413 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-014_9609888b-79bd-4a32-8cbe-79dc0d1592f6 49035-014 HUMAN OTC DRUG EQUATE ANTIBACTERIAL FOAMING HAND SPRING SHOWERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORE INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-014_ce2410d1-0de3-4435-9bdd-f0a7746b6172 49035-014 HUMAN OTC DRUG EQUATE ANTIBACTERIAL FOAMING HAND SPRING SHOWERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-015_0ca0f0d4-603c-4966-aab9-5a867262ecc1 49035-015 HUMAN OTC DRUG Diphenhydramine HCl and Zinc Acetate Anti-Itch Continuous Spray AEROSOL, SPRAY TOPICAL 20130303 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.5; .075 g/88mL; g/88mL N 20181231 49035-016_9196d85a-c3dd-46b8-abb4-7315ed2c07c4 49035-016 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Wal-Mart Stores, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 49035-017_5b7805b0-be13-4878-81ac-9fc3b04a8f2b 49035-017 HUMAN OTC DRUG Maximum Strength Wart Remover with Salicylic Acid Wart Remover with Salicylic Acid LIQUID TOPICAL 20111231 OTC MONOGRAPH FINAL part358B Wal-Mart Stores, Inc. SALICYLIC ACID 17 mg/100mg N 20181231 49035-018_e2ebe2f5-5cea-4acd-b7fd-f4c055baa4c5 49035-018 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20140304 OTC MONOGRAPH FINAL part358F Wal-Mart Stores, Inc. SALICYLIC ACID .17 g/g N 20181231 49035-019_ef1fd96c-ffa4-4070-b4c5-a126f5e92f3a 49035-019 HUMAN OTC DRUG Extra Thick Callus Removers Extra Thick Callus Removers with Salicylic Acid PATCH TOPICAL 20130801 OTC MONOGRAPH FINAL part358F Wal-Mart Stores, Inc. SALICYLIC ACID 40 mg/100mg N 20181231 49035-020_377a73c8-06c1-4405-9521-21db4e483dde 49035-020 HUMAN OTC DRUG Equate Repairing Benzoyl Peroxide LOTION TOPICAL 20111010 OTC MONOGRAPH NOT FINAL part333D Wal-Mart Stores Inc BENZOYL PEROXIDE 25 mg/mL E 20171231 49035-021_4d9de360-92c8-4d41-bb59-7d62656396dc 49035-021 HUMAN OTC DRUG BENZOYL PEROXIDE BENZOYL PEROXIDE KIT TOPICAL 20100226 OTC MONOGRAPH NOT FINAL part333D Wal-Mart Stores Inc N 20181231 49035-022_e6837d64-e885-4999-b481-dcebb1aed420 49035-022 HUMAN OTC DRUG Equate Maximum Strength Spot Treatment BENZOYL PEROXIDE GEL TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333D Wal-Mart Stores Inc BENZOYL PEROXIDE 135 mg/g N 20181231 49035-023_359763f3-d55a-4001-8c9d-a2193118bd4e 49035-023 HUMAN OTC DRUG Equate Cleansing Pads SALICYLIC ACID SWAB TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333D Wal-Mart Stores Inc SALICYLIC ACID 21 mg/1 N 20181231 49035-024_20079dc1-43b6-4daf-b913-6fe07961a55f 49035-024 HUMAN OTC DRUG Equate Acne Treatment Body Pads SALICYLIC ACID SWAB TOPICAL 20110713 OTC MONOGRAPH NOT FINAL part333D Wal-Mart Stores Inc SALICYLIC ACID 20 mg/1 E 20171231 49035-025_9bcec8f7-8532-42b8-92d9-19c5dde5a90b 49035-025 HUMAN OTC DRUG Equate Purifying Cleanser Benzoyl Peroxide GEL TOPICAL 20111010 OTC MONOGRAPH NOT FINAL part333D Wal-Mart Stores Inc BENZOYL PEROXIDE 25 mg/mL E 20171231 49035-026_90074711-62ce-445f-8682-19639b60b3ff 49035-026 HUMAN OTC DRUG ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20140601 OTC MONOGRAPH NOT FINAL part343 WALMART STORES INC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 49035-027_317bbd33-6088-3af1-e054-00144ff8d46c 49035-027 HUMAN OTC DRUG Honey Lemon cough drops menthol LOZENGE ORAL 20160427 OTC MONOGRAPH FINAL part341 Walmart Stores Inc. MENTHOL 7.5 mg/1 N 20181231 49035-028_5bfb52e1-9dab-4b6c-91bc-767ddc7bdcb2 49035-028 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20141031 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49035-029_08ac4053-e0fa-46d6-afb0-ce848f3fde46 49035-029 HUMAN OTC DRUG Equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050309 ANDA ANDA076775 Wal-Mart Stores Inc NICOTINE 2 mg/1 N 20181231 49035-030_f36b3480-fb28-45d8-b4e0-65d08b832e97 49035-030 HUMAN OTC DRUG Calamine Plus FERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE, ZINC OXIDE AEROSOL, SPRAY TOPICAL 20130303 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores, Inc. FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE .345; 2.72; 24.16 mg/mL; mg/mL; mg/mL N 20181231 49035-031_318f27b8-57de-6179-e054-00144ff88e88 49035-031 HUMAN OTC DRUG Herbal Cough Drops Menthol LOZENGE ORAL 20160428 OTC MONOGRAPH FINAL part341 Walmart Stores Inc. MENTHOL 4.8 mg/1 N 20181231 49035-032_3b1a370b-2ab7-4861-b46d-7044879823df 49035-032 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49035-033_61cbd778-48a1-d8b4-e053-2a91aa0a1bfe 49035-033 HUMAN OTC DRUG Instant Ear Dry Equate Isopropyl Alcohol SOLUTION/ DROPS TOPICAL 20140529 OTC MONOGRAPH FINAL part344 WalMart ISOPROPYL ALCOHOL .95 g/100mL N 20191231 49035-034_be89dec9-4df3-4ec4-b125-5cdbabdd4f01 49035-034 HUMAN OTC DRUG Shiny and Sleek pyrithione zinc SHAMPOO TOPICAL 19990206 OTC MONOGRAPH FINAL part358H Wal-Mart PYRITHIONE ZINC 10 mg/mL N 20181231 49035-035_70d9bfa5-9a29-4225-b4e7-9abf6013075e 49035-035 HUMAN OTC DRUG Mineral oil Mineral oil OIL ORAL 20141031 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) MINERAL OIL 100 mg/100mL N 20181231 49035-036_598bbd34-f770-41cd-9af9-0748c8b6fa65 49035-036 HUMAN OTC DRUG Equate Foaming Hand Wash Energy Berry Benzalkonium Chloride SOAP TOPICAL 20170427 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-036_b70dd39c-b628-4799-81bc-6fb02634493f 49035-036 HUMAN OTC DRUG Equate Foaming Hand Wash Energy Berry Benzalkonium Chloride SOAP TOPICAL 20160821 OTC MONOGRAPH NOT FINAL part333E Wal-mart Stores Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-037_bbee8cb0-6b2a-4cda-8a15-ac488ece2cce 49035-037 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 EQUATE (Wal-Mart Stores, Inc.) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 49035-038_f596cb66-ff61-4e6c-a970-242259793d10 49035-038 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19900415 OTC MONOGRAPH FINAL part347 Wal-Mart Stores, Inc PETROLATUM 1 g/g N 20181231 49035-039_0b182fd7-83b9-4530-9f26-d99c3c688fd0 49035-039 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140530 OTC MONOGRAPH FINAL part347 EQUATE (Walmart Stores, Inc.) WITCH HAZEL 842 mg/mL N 20181231 49035-040_40e2aedd-aae9-598e-e054-00144ff8d46c 49035-040 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20140730 OTC MONOGRAPH FINAL part341 Walmart Stores Inc MENTHOL 5.8 mg/1 N 20181231 49035-041_4492c96a-c686-404e-ae15-b482acc3bb02 49035-041 HUMAN OTC DRUG Nighttime Cold and Flu acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090807 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 49035-042_b6b4130f-da27-4079-935f-1774f73c5af5 49035-042 HUMAN OTC DRUG equate pain and fever childrens Acetaminophen SUSPENSION ORAL 20151106 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL N 20181231 49035-043_619235d9-83d3-6020-e053-2a91aa0a5cbb 49035-043 HUMAN OTC DRUG equate Fiber Therapy Original Texture Unflavored PSYLLIUM HUSK GRANULE, FOR SOLUTION ORAL 20120905 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc PSYLLIUM HUSK 3.4 g/7g N 20181231 49035-044_a3796c9d-88b4-4dbd-b9d0-1b25296e4cdb 49035-044 HUMAN OTC DRUG NiteTime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 49035-045_40f86686-51e7-43d0-e054-00144ff88e88 49035-045 HUMAN OTC DRUG Sugar Free Hiney Lemon Cough Drops Menthol LOZENGE ORAL 20140703 OTC MONOGRAPH FINAL part341 Walmart Stores Inc. MENTHOL 7.6 mg/1 N 20181231 49035-046_40f9338f-41ae-19a8-e054-00144ff8d46c 49035-046 HUMAN OTC DRUG Cherry Antacid Soft Chews calcium carbonate TABLET, CHEWABLE ORAL 20161110 OTC MONOGRAPH FINAL part331 Walmart Stores Inc. CALCIUM CARBONATE 1177 mg/1 N 20181231 49035-047_33820ab2-137a-4a51-8c53-9f0412bd43db 49035-047 HUMAN OTC DRUG Acetaminophen PM Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20141130 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 49035-048_4171e196-8f21-276a-e054-00144ff8d46c 49035-048 HUMAN OTC DRUG Assorted Fruit Antacid Flavor Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20160830 OTC MONOGRAPH FINAL part331 Walmart Stores CALCIUM CARBONATE 750 mg/1 N 20181231 49035-050_4706234f-5579-4bb2-a3c4-28d54061c39d 49035-050 HUMAN OTC DRUG First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 49035-051_4181004c-c4ce-4d6c-e054-00144ff88e88 49035-051 HUMAN OTC DRUG Assorted Fruit Antacid Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20160830 OTC MONOGRAPH FINAL part331 Walmart Stores CALCIUM CARBONATE 750 mg/1 N 20181231 49035-052_6294deeb-17fa-48d7-9a4e-9f31b83eced3 49035-052 HUMAN OTC DRUG Childrens Allergy Relief Fexofenadine Hydrochloride SUSPENSION ORAL 20150701 ANDA ANDA203330 Wal-Mart Stores Inc FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 49035-053_f1e45b42-6d18-4069-94a4-eebf3a9ce1f4 49035-053 HUMAN OTC DRUG Cold and Flu severe Acetaminophen,Dextromethorphan HBr,Guaifenesin,Phenylephrine HCl TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49035-055_5837ed0e-e893-4182-9566-0d1ead627222 49035-055 HUMAN OTC DRUG Equate Baby Advanced Healing Petrolatum OINTMENT TOPICAL 20170713 OTC MONOGRAPH FINAL part347 Wal-Mart Store Inc PETROLATUM .41 g/g N 20181231 49035-055_70a067bd-8c82-4385-92b8-8c40a3747458 49035-055 HUMAN OTC DRUG Equate Baby Advanced Healing Petrolatum OINTMENT TOPICAL 20170522 OTC MONOGRAPH FINAL part347 Wal-mart Stores Inc PETROLATUM .41 g/g N 20181231 49035-058_491164c1-6247-5e1d-e054-00144ff8d46c 49035-058 HUMAN OTC DRUG Mixed Berry Antacid and Anti-Gas Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20160830 OTC MONOGRAPH FINAL part331 Walmart Stores CALCIUM CARBONATE; DIMETHICONE 750; 80 mg/1; mg/1 N 20181231 49035-059_6242c677-c0a8-4463-9129-fab3a7674339 49035-059 HUMAN OTC DRUG Equate Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20170613 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Store Inc ALCOHOL 650 mg/mL N 20181231 49035-060_8a6e73e9-be5c-3b70-1519-0030df7845a1 49035-060 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160610 ANDA ANDA208150 Walmart FLUTICASONE PROPIONATE 50 ug/1 N 20181231 49035-061_fdf600f7-5fc6-4fa2-8d40-29b38db62e02 49035-061 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Wal-Mart Stores Inc LORATADINE 5 mg/5mL N 20181231 49035-062_bbb6bc13-d2f6-4587-8b17-9ddd48e8d268 49035-062 HUMAN OTC DRUG Parents Choice Daily Moisturizing Dimethicone LOTION TOPICAL 20170613 OTC MONOGRAPH FINAL part347 Wal-Mart Stores Inc DIMETHICONE 12 mg/mL N 20181231 49035-063_0c7e5219-3c5d-40c2-e952-9560f6d9f29f 49035-063 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20171011 ANDA ANDA208150 Walmart FLUTICASONE PROPIONATE 50 ug/1 N 20181231 49035-064_f59a28a9-8bcd-46e3-ad27-a42065f3e988 49035-064 HUMAN OTC DRUG Equate Candied Watermelon Antibacterial Hand With Moisturizer Benzalkonium Chloride SOAP TOPICAL 20180105 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 49035-065_ca25cf8f-acdb-4267-8836-2ccf6c038aa9 49035-065 HUMAN OTC DRUG Ibuprofen and Diphenhydramine HCl IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED ORAL 20151231 ANDA ANDA090397 EQUATE (Walmart Stores, Inc.) IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE 200; 25 mg/1; mg/1 N 20181231 49035-066_6183f62c-3098-0d74-e053-2a91aa0a7be3 49035-066 HUMAN OTC DRUG equate Sugar Free Fiber Therapy Smooth Texture Orange Flavor PSYLLIUM HUSK GRANULE, FOR SOLUTION ORAL 20120905 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc PSYLLIUM HUSK 3.5 g/5.8g N 20181231 49035-067_706a0509-3e0c-416a-918a-26955c5ebd76 49035-067 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate OINTMENT TOPICAL 20100831 20180331 OTC MONOGRAPH FINAL part333B Wal-Mart Stores Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 49035-068_4b09ed20-909f-415c-8d6f-313e99ae52a0 49035-068 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140212 ANDA ANDA079096 EQUATE (Walmart Stores, Inc.) NAPROXEN SODIUM 220 mg/1 N 20181231 49035-069_6184042c-45db-4caa-e053-2a91aa0aee69 49035-069 HUMAN OTC DRUG equate Fiber Therapy Smooth Texture Orange Flavor PSYLLIUM HUSK GRANULE, FOR SOLUTION ORAL 20121001 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc PSYLLIUM HUSK 3.4 g/12g N 20181231 49035-070_da034b2b-c752-4086-92eb-28d81d1fa4c0 49035-070 HUMAN OTC DRUG Mucus Guaifenesin TABLET, EXTENDED RELEASE ORAL 20171115 NDA NDA021282 WALMART STORES, INC. GUAIFENESIN 600 mg/1 N 20181231 49035-071_7403f735-d7bd-4f09-8219-c2c1c4460f57 49035-071 HUMAN OTC DRUG Body Menthol POWDER TOPICAL 20120110 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores, Inc MENTHOL 1.5 mg/g N 20181231 49035-072_6d6705f4-a9b4-4ea5-a769-a9fe363558fb 49035-072 HUMAN OTC DRUG Antiseptic Mouthrinse Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 19891111 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 49035-073_67eeef9a-45a0-449d-b2b8-bea72baa071e 49035-073 HUMAN OTC DRUG Body Wash Salicylic Acid GEL TOPICAL 20150115 OTC MONOGRAPH FINAL part333D Wal-Mart Stores, Inc SALICYLIC ACID 25 mg/mL N 20181231 49035-074_e622938c-a1a4-48ab-bed1-50c7580b7a8b 49035-074 HUMAN OTC DRUG Guaifenesin Extended Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20171210 NDA NDA021282 WALMART STORES, INC. GUAIFENESIN 1200 mg/1 N 20181231 49035-075_29a9c7bf-d45e-45c6-a4eb-c7dd229e4db2 49035-075 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA021920 EQUATE (Walmart Stores, Inc.) NAPROXEN SODIUM 220 mg/1 N 20181231 49035-076_8376c1b3-b451-4cfd-91d9-117fbdf3dcc1 49035-076 HUMAN OTC DRUG Isopropyl alcohol 70 percent Wintergreen Isopropyl alcohol LIQUID TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part333A EQUATE (Walmart Stores, Inc.) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 49035-077_7875436d-046f-4e14-ab1b-c9b23c5536ac 49035-077 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20171015 NDA NDA021620 WALMART STORES, INC. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 49035-078_0e384653-6714-4ae2-ac0d-d08b878a1141 49035-078 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20171231 OTC MONOGRAPH NOT FINAL part334 EQUATE (Wal-Mart Stores, Inc.) DOCUSATE SODIUM 100 mg/1 N 20191231 49035-079_0fa49ae8-d1dd-41bc-ad32-1f78cfc6c479 49035-079 HUMAN OTC DRUG Antibacterial Hand Wash Benzalkonium chloride 0.13% LIQUID TOPICAL 20160728 OTC MONOGRAPH NOT FINAL part333A Wal-Mart, Inc BENZALKONIUM CHLORIDE 1.313 mg/mL N 20181231 49035-080_b2ea9d75-5626-47fa-93f9-222942bb65ad 49035-080 HUMAN OTC DRUG equate Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Wal-Mart Stores Inc TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 49035-081_299036f0-f6f8-4870-8264-0c6283c3ae8a 49035-081 HUMAN OTC DRUG Equate Spring Rain Liquid Hand Benzalkonium Chloride SOAP TOPICAL 20180111 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 49035-082_d3d21c07-4a73-4421-8caf-a7127a39fee6 49035-082 HUMAN OTC DRUG equate childrens cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20060812 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 49035-084_1614b4f3-2997-4bac-b89c-de8dee13cc83 49035-084 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative Docusate sodium, Sennosides TABLET ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 49035-085_c5e12887-e185-4add-bdbb-0172e595301e 49035-085 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 49035-086_ace9b879-f2fb-4c0f-b046-e69d7340dd9b 49035-086 HUMAN OTC DRUG Equate Dry Scalp Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20180205 OTC MONOGRAPH FINAL part358H Wal-Mart Stores Inc PYRITHIONE ZINC 10 mg/mL N 20191231 49035-087_07857100-01f6-4f7e-87e3-e724562248fd 49035-087 HUMAN OTC DRUG Equate Everyday Clean Gentle Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20180205 OTC MONOGRAPH FINAL part358H Wal-Mart Stores Inc PYRITHIONE ZINC 10 mg/mL N 20191231 49035-088_67cd0670-e085-4ecd-836e-97efc8e99087 49035-088 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 49035-089_6413c0ec-1605-61a2-e053-2a91aa0aca0e 49035-089 HUMAN OTC DRUG Herbal Cough Drops Menthol LOZENGE ORAL 20180131 OTC MONOGRAPH FINAL part341 Walmart MENTHOL 4.8 mg/1 N 20191231 49035-090_3bbc126e-dce5-4d1b-8276-975ebf23958a 49035-090 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110928 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-090_74cd7978-b7b1-459a-91df-03b2748b7cd8 49035-090 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120907 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-091_76baf4c6-a130-4419-af13-e5030654fdaf 49035-091 HUMAN OTC DRUG All Day Moisturizing Octinoxate, zinc oxide LOTION TOPICAL 20060407 OTC MONOGRAPH FINAL part352 Wal-Mart Stores, Inc OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 49035-092_b12e1df6-1da9-4d77-9862-667dbc1030f6 49035-092 HUMAN OTC DRUG equate Childrens Allergy Relief Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Wal-Mart Stores Inc LORATADINE 5 mg/5mL N 20181231 49035-096_2f926a41-bf6a-4982-9ba8-ffa57f25f681 49035-096 HUMAN OTC DRUG equate flu and severe cold and cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20120228 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 49035-098_e24b94b8-96d9-4297-be24-12a7f6bb17b6 49035-098 HUMAN OTC DRUG Equate Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20130809 NDA NDA021920 Wal-Mart Stores Inc NAPROXEN SODIUM 220 mg/1 N 20181231 49035-099_11e46343-58f9-46ee-9ddb-d5f99f5b2550 49035-099 HUMAN OTC DRUG Vaporizing Camphor INHALANT RESPIRATORY (INHALATION) 20140307 OTC MONOGRAPH FINAL part341 Wal-Mart Stores, Inc CAMPHOR (SYNTHETIC) 62 mg/mL N 20181231 49035-100_e615a06f-ac7d-0ba9-fc5c-7de9849c7bb0 49035-100 HUMAN OTC DRUG Equate Ranitidine Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20150215 ANDA ANDA200172 Wal-Mart Stores Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 49035-101_6a18cd92-cc51-401b-9074-fbaa1afb42ac 49035-101 HUMAN OTC DRUG equate Ultra Strength Antacid Peppermint Flavor Antacid Tablets TABLET, CHEWABLE ORAL 20151012 OTC MONOGRAPH FINAL part331 Wal-Mart Stores,Inc., CALCIUM CARBONATE 1000 mg/1 E 20171231 49035-104_0c9b9dde-0e27-4eaa-a2c0-4b6818a928ee 49035-104 HUMAN OTC DRUG Pretty in Paris Hand Sanitizer bodycology Alcohol LIQUID TOPICAL 20130521 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc ALCOHOL 75 g/100mL E 20171231 49035-105_448d1c72-2308-4041-8ba6-dd1e0802cc47 49035-105 HUMAN OTC DRUG equate Extra Strength Antacid aluminum hydroxide and magnesium carbonate TABLET, CHEWABLE ORAL 20151020 OTC MONOGRAPH FINAL part331 Wal-Mart Stores,Inc ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 N 20181231 49035-105_7fb82ca2-15d3-4c96-bea1-24b7a7e813f5 49035-105 HUMAN OTC DRUG Equate Childrens acetaminophen Acetaminophen SUSPENSION ORAL 19960402 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL N 20181231 49035-106_70de80f9-9cfb-44b2-90f4-f8bce4c20618 49035-106 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 49035-107_628e51b6-51bb-4b4e-a516-9994ca05790b 49035-107 HUMAN OTC DRUG blackberry vanilla hand sanitizer bodycology Alcohol LIQUID TOPICAL 20130521 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc ALCOHOL 75 g/100mL E 20171231 49035-108_f5f4eefa-d8f5-4b68-81f6-915545331974 49035-108 HUMAN OTC DRUG sweet love hand sanitizer bodycology Alcohol LIQUID TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc ALCOHOL 75 g/100mL E 20171231 49035-109_c4bee47e-a5be-4159-b419-fe5725843021 49035-109 HUMAN OTC DRUG winter vanilla hand sanitizer bodycology Alcohol LIQUID TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc ALCOHOL 75 1/100mL E 20171231 49035-110_0fe94699-e766-464c-80fb-343fa12f8d15 49035-110 HUMAN OTC DRUG EQUATE SPRING SHOWERS ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC. TRICLOSAN 4.6 mg/mL N 20181231 49035-110_51d1d0d2-7f33-4e4d-9fa7-beec3ea7cdd9 49035-110 HUMAN OTC DRUG EQUATE SPRING SHOWERS ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC. TRICLOSAN 4.6 mg/mL N 20181231 49035-111_26d6f847-ae05-4ea2-869c-e8108b5846f7 49035-111 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120301 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 100 mg/1 N 20181231 49035-113_b5ec1f20-2826-4dac-8e19-fbcb970c2526 49035-113 HUMAN OTC DRUG frosted sugar plum hand sanitizer bodycology Alcohol LIQUID TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc ALCOHOL 75 g/100mL E 20171231 49035-114_e5713d3d-eff9-4c1e-9745-9c31c310698b 49035-114 HUMAN OTC DRUG EQUATE SPRING SHOWERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131030 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-114_fc9b67d2-2da2-4e16-8aaf-84521fd66ef5 49035-114 HUMAN OTC DRUG EQUATE SPRING SHOWERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-115_6013756e-6b7d-e5a7-e053-2a91aa0abcbe 49035-115 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150215 20200430 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 100 mg/1 N 20181231 49035-116_b36edcf5-bd0c-47d8-b9c8-646d8a85f74b 49035-116 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20160314 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc DOCUSATE SODIUM 100 mg/1 N 20181231 49035-117_a664a000-fcfe-cf73-9154-8ed6706fe9bf 49035-117 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20170629 ANDA ANDA200172 Wal-mart Stores Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 49035-118_1a69e4a7-4053-accf-8571-97d82bd8229d 49035-118 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20120705 ANDA ANDA077367 Wal-Mart Stores Inc FAMOTIDINE 10 mg/1 N 20181231 49035-119_504b8282-d93f-454f-9f93-84cb8a9105d7 49035-119 HUMAN OTC DRUG equate omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150902 NDA NDA022032 Wal-Mart Stores Inc OMEPRAZOLE 20 mg/1 N 20181231 49035-120_8901a21d-1963-4d31-a42f-caa47cdc6d48 49035-120 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20151215 OTC MONOGRAPH FINAL part333B Wal-Mart Stores, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 49035-121_da75f3ed-4f2f-428a-8777-b59cffe77a08 49035-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20150228 ANDA ANDA202300 EQUATE (Walmart Stores, Inc.) IBUPROFEN 200 mg/1 N 20181231 49035-123_a7875f9c-fdf7-4def-a860-61465184716f 49035-123 HUMAN OTC DRUG Clotrimazole Jock Itch Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Wal-Mart Stores, Inc. CLOTRIMAZOLE 10 mg/g N 20181231 49035-124_011eec57-f84c-4236-a480-569061470e94 49035-124 HUMAN OTC DRUG equate nicotine Nicotine Polacrilex LOZENGE ORAL 20090910 ANDA ANDA090711 Wal-Mart Stores Inc NICOTINE 2 mg/1 N 20181231 49035-125_2fab799b-1988-4965-af61-93ca5d15b2c6 49035-125 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION ORAL 20120521 ANDA ANDA079058 Wal-Mart Stores Inc IBUPROFEN 50 mg/1.25mL N 20181231 49035-126_a99741c8-aaea-4e1b-930c-5621d6cd6a86 49035-126 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20120517 ANDA ANDA074916 Wal-Mart Stores Inc IBUPROFEN 100 mg/5mL N 20181231 49035-128_0becc489-941b-4e34-bbd0-338dec9ab0e5 49035-128 HUMAN OTC DRUG Famotidine original strength Famotidine TABLET ORAL 20121218 ANDA ANDA077146 EQUATE (Walmart Stores, Inc.) FAMOTIDINE 10 mg/1 N 20181231 49035-129_ef8d8a53-09c2-47c9-b798-f62ea14a5888 49035-129 HUMAN OTC DRUG Parents Choice Advanced Healing Petrolatum OINTMENT TOPICAL 20170713 OTC MONOGRAPH FINAL part347 Wal-Mart Stores Inc PETROLATUM .41 mg/g N 20181231 49035-131_5693b0b2-ec0d-49c4-ad67-ef03b93b64a5 49035-131 HUMAN OTC DRUG Equate Suphedrine PE Phenylephrine Hydrochloride TABLET ORAL 20140321 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 49035-132_35b9b047-8169-4537-aad7-07f1df0b6333 49035-132 HUMAN OTC DRUG Equate Beauty Acne Foaming Cleanser Benzoyl Peroxide LIQUID TOPICAL 20170713 OTC MONOGRAPH FINAL part333D Wal-Mart Stores Inc BENZOYL PEROXIDE .1 mg/g N 20181231 49035-133_f1f051d8-b8d8-4afd-84d8-82a59d9fa4fb 49035-133 HUMAN OTC DRUG Equate Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20140702 ANDA ANDA079205 Walmart stores Inc IBUPROFEN 200 mg/1 N 20181231 49035-134_23221f9b-ed3d-4a77-bf6e-c2430dd2adf9 49035-134 HUMAN OTC DRUG equate SPORT Sunscreen Broad Spectrum AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20161114 OTC MONOGRAPH NOT FINAL part352 Wal-Mart Stores Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.11; 30.81; 11.85; 23.7; 14.22 g/237mL; g/237mL; g/237mL; g/237mL; g/237mL N 20181231 49035-137_4fbbc5e1-749d-2ec5-e054-00144ff88e88 49035-137 HUMAN OTC DRUG Equate Beauty Acne Cleansing Bar Benzoyl Peroxide SOAP TOPICAL 20170517 OTC MONOGRAPH FINAL part333D Wal-Mart Stores, Inc. BENZOYL PEROXIDE 100 mg/g N 20181231 49035-138_694c0716-ee8a-48fa-82dc-d494bbddc442 49035-138 HUMAN OTC DRUG Equate Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20150115 UNAPPROVED DRUG OTHER Walmart PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20191231 49035-140_ad995658-b0be-4ce3-baa2-dbdf787ece17 49035-140 HUMAN OTC DRUG Equate Naproxen Sodium Naproxen sodium TABLET, FILM COATED ORAL 20130809 ANDA ANDA074661 Wal-Mart Stores Inc NAPROXEN SODIUM 200 mg/1 N 20181231 49035-142_07c1a066-9750-424a-b295-01e4f6bfffc8 49035-142 HUMAN OTC DRUG Equate vagicaine maximum strength Benzocaine, Resorcinol CREAM TOPICAL 20050628 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g N 20181231 49035-143_f54ec0bf-6d4a-476f-a232-a73ad482b23e 49035-143 HUMAN OTC DRUG equate Clinical Strength Antiperspirant/Deodorant Aluminum zirconium trichlorohydrex gly STICK TOPICAL 20090505 OTC MONOGRAPH FINAL part350 Wal-mart Stores, Inc. ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g N 20181231 49035-144_de77a3f3-085f-461e-9ec3-8f8446fe37d8 49035-144 HUMAN OTC DRUG equate MEN COOL OCEAN ANTIPERSPIRANT Aluminum zirconium octachlorohydrex Gly GEL TOPICAL 20170102 OTC MONOGRAPH FINAL part350 Wal-mart Stores, Inc. ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY .16 g/g N 20181231 49035-145_5c6ba700-0a7f-4231-abfa-f0726955579a 49035-145 HUMAN OTC DRUG Equate Support Moisture Lubricant Eye Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20150204 OTC MONOGRAPH FINAL part349 Wal-Mart Stores, Inc. PROPYLENE GLYCOL 6 mg/mL N 20191231 49035-150_4eff620e-ec4e-4655-9f7b-40bc655f9605 49035-150 HUMAN OTC DRUG Stool Softener Extra strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140224 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 250 mg/1 N 20181231 49035-151_a2c85ab2-bc07-43a7-81b0-495c833b1720 49035-151 HUMAN OTC DRUG Equate Corn and Callus Remover Salicylic Acid LIQUID TOPICAL 20101001 OTC MONOGRAPH FINAL part358B Wal-Mart Stores Inc. SALICYLIC ACID 170 mL/mL N 20181231 49035-152_15f6de88-46f8-4c0d-92d7-84da2d375c9d 49035-152 HUMAN OTC DRUG Equate One Step Corn Remover Pad Salicylic Acid LIQUID TOPICAL 20101001 OTC MONOGRAPH FINAL part358B Wal-Mart Stores Inc. SALICYLIC ACID 40 mg/1 N 20181231 49035-153_b27846ce-2925-4ce8-9d63-b06fdc3b6b22 49035-153 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950715 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 49035-156_b6f8e977-4f1f-41a7-9a15-14b9898079cf 49035-156 HUMAN OTC DRUG Equate Barrier Cream Barrier Cream CREAM TOPICAL 20170228 OTC MONOGRAPH FINAL part347 WALMART STORES INC ZINC OXIDE; MENTHOL 200; 4.5 mg/g; mg/g N 20181231 49035-157_813dfe1c-3f61-4e03-9edd-0cbca0bf5d53 49035-157 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 325 mg/1 N 20181231 49035-158_6b5cc061-cca4-4a62-a9a1-e653ae690366 49035-158 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20130930 OTC MONOGRAPH NOT FINAL part343 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN 500 mg/1 N 20181231 49035-161_a6286824-2514-444f-ab2a-3378522191b5 49035-161 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20130315 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 49035-163_eb374aa0-5997-4602-b9f7-3761d1a5c3ba 49035-163 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20060513 OTC MONOGRAPH FINAL part355 Wal-Mart SODIUM FLUORIDE 999.5 mL/100L N 20181231 49035-165_11faa53e-c638-4042-ae93-c091f8c6db41 49035-165 HUMAN OTC DRUG Severe Congestion Relief Maximum Strength Sinus Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140630 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20191231 49035-166_60730a7e-ad03-4cba-8329-f1892a171ddb 49035-166 HUMAN OTC DRUG equate ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020416 ANDA ANDA074937 Wal-Mart Stores Inc IBUPROFEN 100 mg/5mL N 20191231 49035-168_86810df2-eea7-4074-9f7c-3efa818e240d 49035-168 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20111024 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC TRICLOSAN .6 mL/100mL N 20181231 49035-170_f7b7fdc0-7102-4740-adff-1a2393e73fb1 49035-170 HUMAN OTC DRUG Equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050322 ANDA ANDA076789 Wal-Mart Stores Inc NICOTINE 4 mg/1 N 20181231 49035-173_27283cd3-43bb-40e6-b6d4-fdd7d3749fb6 49035-173 HUMAN OTC DRUG equate lice treatment Piperonyl Butoxide, Pyrethrum Extract KIT 20070807 OTC MONOGRAPH FINAL part358G Wal-Mart Stores Inc N 20181231 49035-173_fe11d8a2-3a94-4d95-84eb-b47f7b0aff55 49035-173 HUMAN OTC DRUG equate lice treatment Piperonyl Butoxide, Pyrethrum Extract KIT 20070807 OTC MONOGRAPH FINAL part358G Wal-Mart Stores Inc N 20181231 49035-175_4a141915-ed33-4e43-8f1a-8a10d9df63cf 49035-175 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 500 mg/1 N 20181231 49035-177_f3f112dd-d22f-43fb-88f2-fabfae234e9f 49035-177 HUMAN OTC DRUG EQUATE ANTIBACTERIAL FOAMING Triclosan SOAP TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC TRICLOSAN .46 mL/100mL N 20181231 49035-180_72c9c5c9-c782-41fa-bdd5-2bd2c2ee9eb5 49035-180 HUMAN OTC DRUG Healing Healing Ointment OINTMENT TOPICAL 20071202 OTC MONOGRAPH FINAL part347 Wal Mart PETROLATUM 41 kg/g N 20181231 49035-183_cd91b99e-f6cc-4653-8740-9ede653d591a 49035-183 HUMAN OTC DRUG Childrens allergy relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Wal-Mart Stores Inc LORATADINE 5 mg/5mL N 20181231 49035-186_09307b4d-b130-45f3-b85f-50ca08cbe6b4 49035-186 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20150504 ANDA ANDA076460 EQUATE (Walmart Stores, Inc.) IBUPROFEN 200 mg/1 N 20181231 49035-187_6748528c-7549-4d8e-bd42-41f492fb9bb8 49035-187 HUMAN OTC DRUG Equate Anti-Wrinkle Avobenzone and Octocrylene CREAM TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Walmart Stores Inc. AVOBENZONE; OCTOCRYLENE 3; 10 g/100g; g/100g N 20181231 49035-188_81ecb091-38da-4b3e-a0a1-b4986b97ee09 49035-188 HUMAN OTC DRUG Equate Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140102 OTC MONOGRAPH FINAL part346 Wal-Mart Stores Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 49035-189_f2eb3005-b0e4-4404-bf97-0a1c9910e5b5 49035-189 HUMAN OTC DRUG Equate Restore Tears Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20140410 OTC MONOGRAPH FINAL part349 Wal-Mart Stores, Inc. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20191231 49035-190_0460182e-1b0a-4ffb-ba86-b9f7e59802b4 49035-190 HUMAN OTC DRUG Equate Nicotine Nicotine Polacrilex LOZENGE ORAL 20090910 ANDA ANDA090711 Wal-Mart Stores Inc NICOTINE 4 mg/1 N 20181231 49035-191_efe9c35e-163d-490b-98cb-bdf32294a50e 49035-191 HUMAN OTC DRUG Equate Restore PM Nighttime Lubricant Eye Mineral Oil and Petrolatum OINTMENT OPHTHALMIC 20130314 OTC MONOGRAPH FINAL part349 Wal-Mart Stores, Inc. MINERAL OIL; PETROLATUM 425; 573 mg/g; mg/g N 20191231 49035-194_7621fc78-1091-45cf-bdc8-a5a40987078f 49035-194 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20101019 NDA AUTHORIZED GENERIC NDA020165 Wal-Mart Stores Inc NICOTINE 21 mg/24h N 20181231 49035-195_7621fc78-1091-45cf-bdc8-a5a40987078f 49035-195 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20101019 NDA AUTHORIZED GENERIC NDA020165 Wal-Mart Stores Inc NICOTINE 14 mg/24h N 20181231 49035-196_7621fc78-1091-45cf-bdc8-a5a40987078f 49035-196 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20101019 NDA AUTHORIZED GENERIC NDA020165 Wal-Mart Stores Inc NICOTINE 7 mg/24h N 20181231 49035-197_2755662a-389d-4553-844b-97f0a35bd603 49035-197 HUMAN OTC DRUG Equate Comfort Carboxymethylcellulose Sodium and Hypromelloses GEL OPHTHALMIC 20140410 OTC MONOGRAPH FINAL part349 Wal-Mart Stores, Inc. HYPROMELLOSES; CARBOXYMETHYLCELLULOSE SODIUM 3; 2.5 mg/mL; mg/mL N 20191231 49035-198_c0080c27-9503-44d8-ab33-8a8fd187b423 49035-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20121211 ANDA ANDA078682 EQUATE (Walmart Stores, Inc.) IBUPROFEN 200 mg/1 N 20181231 49035-199_1800b776-0b58-416c-ae56-e17a6368cc91 49035-199 HUMAN OTC DRUG equate miconazole 1 Miconazole nitrate KIT 20100609 ANDA ANDA079114 Wal-Mart Stores Inc N 20181231 49035-200_ac30251d-0c00-4667-a2ae-a1461c94d1cf 49035-200 HUMAN OTC DRUG equate allergy relief Fluticasone propionate SPRAY, METERED NASAL 20160528 ANDA ANDA207957 Wal-Mart Stores Inc FLUTICASONE PROPIONATE 50 ug/1 N 20181231 49035-201_4fef2281-ef57-44e0-bcf6-15d2b896ad2b 49035-201 HUMAN OTC DRUG Equate Nicotine Nicotine Polacrilex LOZENGE ORAL 20161011 ANDA ANDA090821 Wal-Mart Stores Inc NICOTINE 2 mg/1 N 20181231 49035-202_4d4c9a1a-436e-4481-94a6-e56ef829bc54 49035-202 HUMAN OTC DRUG equate hair regrowth treatment for women minoxidil SOLUTION TOPICAL 20110127 ANDA ANDA075357 Wal-Mart Stores Inc MINOXIDIL 2 g/100mL N 20181231 49035-205_b9c13542-3345-4bac-a617-b0132af40123 49035-205 HUMAN OTC DRUG equate athletes foot powder Tolnaftate SPRAY TOPICAL 20040929 OTC MONOGRAPH FINAL part333C Wal-Mart Stores Inc TOLNAFTATE 1 g/100g N 20191231 49035-206_61043a74-d49f-4888-bf1f-f8ff6131eab8 49035-206 HUMAN OTC DRUG equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050308 ANDA ANDA078325 Wal-Mart Stores Inc NICOTINE 2 mg/1 N 20181231 49035-210_7c73e1a0-6b72-4bd6-8c58-f9f6f6dfeef9 49035-210 HUMAN OTC DRUG Advanced Citrus Eucalyptol MOUTHWASH ORAL 20100722 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 49035-211_f79322b1-4f8d-4c27-aaff-1ec6e3daab4f 49035-211 HUMAN OTC DRUG Hand Sanitizer Pink Strawberry Lollipop Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 63 mL/100mL E 20171231 49035-212_bd540f68-6ea4-403e-a2be-6deccf444d3b 49035-212 HUMAN OTC DRUG Hand Sanitizer Winter Jelly Bean Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL E 20171231 49035-213_72d820d8-3ec9-4f46-beb3-1ad29db6b8d5 49035-213 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20010806 OTC MONOGRAPH FINAL part355 Wal-Mart SODIUM FLUORIDE .5 mg/mL N 20181231 49035-214_934c51da-92e2-4945-a33f-43c6fcacc937 49035-214 HUMAN OTC DRUG Hand Sanitizer Passionfruit Pomegranate Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL E 20171231 49035-216_0d8121c6-f53f-4a5a-b27b-eeb0340e3f69 49035-216 HUMAN OTC DRUG Hand Sanitizer Sweet Sugar Cookie Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL E 20171231 49035-217_11103326-12da-4a41-8b3c-9f18fa894946 49035-217 HUMAN OTC DRUG Hand Sanitizer Orange Tangerine Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL E 20171231 49035-218_16d68fd9-af59-43fc-9b26-1bcd7b3b0e5c 49035-218 HUMAN OTC DRUG Hand Sanitizer Juicy Blueberry Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL E 20171231 49035-219_f64abd39-98e9-4553-b6ad-f6533442085c 49035-219 HUMAN OTC DRUG Hand Sanitizer Spicy Peppermint Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL E 20171231 49035-220_4ebf2fa8-b7c3-4d50-ad0b-f9b19ca495c2 49035-220 HUMAN OTC DRUG Hand Sanitizer Sugared Berry Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL E 20171231 49035-221_86946ee9-b074-4020-a3ce-30ad5af353e6 49035-221 HUMAN OTC DRUG Hand Sanitizer Cranberry Tart Alcohol LIQUID TOPICAL 20140418 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL E 20171231 49035-222_0c84f88d-2b27-49ff-b5e7-7c5fca574fd9 49035-222 HUMAN OTC DRUG Hand Sanitizer Sugar Coated Plum Alcohol LIQUID TOPICAL 20140418 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 62 mL/100mL E 20171231 49035-223_5f0d41bd-5df5-4416-ad36-8389d475aeca 49035-223 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20140630 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 49035-224_7c539531-a337-43b9-b1e3-c0524e457a6d 49035-224 HUMAN OTC DRUG Equate anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030214 ANDA ANDA075232 Wal-Mart Stores Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 49035-226_5da7f51a-0730-496f-a538-91638c29f970 49035-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 Wal-Mart Stores Inc CAFFEINE 200 mg/1 N 20181231 49035-229_f373be1f-b2d9-4a96-86f3-999373718001 49035-229 HUMAN OTC DRUG Acne Treatment Benzoyl peroxide GEL TOPICAL 20150106 OTC MONOGRAPH FINAL part333D Wal-Mart Stores, Inc BENZOYL PEROXIDE 1 mg/g N 20181231 49035-230_e27db65b-9f66-4e15-880e-b4ddac4c82f9 49035-230 HUMAN OTC DRUG Nighttime Sleep Aid maximum strength Diphenhydramine HCl CAPSULE ORAL 20100706 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 49035-232_dc00aea6-d444-46f1-97dd-c466c7c0f221 49035-232 HUMAN OTC DRUG Ritz Spritz Mulled Cranberry Alcohol GEL TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 63 1/100g E 20171231 49035-233_87fec9c3-ad5c-46e7-a6ea-57385cb7e63a 49035-233 HUMAN OTC DRUG Glitter Ritz Iced Berry Alcohol GEL TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 63 1/100g E 20171231 49035-234_6376f16a-d05f-4862-8630-0300b8e0b62b 49035-234 HUMAN OTC DRUG Glitter Ritz Golden Vanilla Embers Alcohol GEL TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc. ALCOHOL 63 1/100g E 20171231 49035-235_1f338e2a-4810-4351-a930-6b32a67e3c09 49035-235 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 20190525 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 49035-236_0055e6ef-2e24-434f-b9dd-40edcd544ddd 49035-236 HUMAN OTC DRUG Sleep Aid maximum strength DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 49035-237_d1216fac-6c52-4f52-9d0a-a2ac40e05bf3 49035-237 HUMAN OTC DRUG NIGHTTIME SLEEP AID Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg CAPSULE, LIQUID FILLED ORAL 20131031 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 49035-238_855c6ccc-783d-4d2d-818c-54e2180cde47 49035-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130830 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 100 mg/1 N 20181231 49035-240_778d5b9e-33ac-441a-9dbe-6bdd21a9a155 49035-240 HUMAN OTC DRUG Maximum Strength One Step Wart Remover Strips Maximum Strength One Step Wart Remover Strips with Salicylic Acid PLASTER TOPICAL 20130801 OTC MONOGRAPH FINAL part358B Wal-Mart Stores, Inc. SALICYLIC ACID .4 g/g N 20181231 49035-242_522615f7-cddf-4b1c-bb11-8203f638c040 49035-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH FINAL part347 EQUATE (Walmart Stores, Inc.) DIMETHICONE 125 mg/1 N 20181231 49035-244_53dc277a-abc5-4217-90dc-42e0c7502a02 49035-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 100 mg/1 N 20181231 49035-246_4f32e6df-2272-40ef-b2d6-08af71dd5a05 49035-246 HUMAN OTC DRUG Each Relief Equate Diphenhydramine HCI 2% GEL TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 Walmart DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100mL N 20181231 49035-248_63a4ee97-ab64-47b8-8463-3af893dfc2d2 49035-248 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20131230 ANDA ANDA079174 EQUATE (Walmart Stores, Inc.) IBUPROFEN 200 mg/1 N 20181231 49035-251_644a7761-7fdd-43b3-aa79-94d7a7c5cba9 49035-251 HUMAN OTC DRUG arthricream Trolamine Salicylate CREAM TOPICAL 20090425 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc TROLAMINE SALICYLATE 10 g/100g N 20181231 49035-252_76f204ca-6d4d-4587-ba84-d50281043413 49035-252 HUMAN OTC DRUG Equate Athletes Foot TOLNAFTATE CREAM TOPICAL 20160831 OTC MONOGRAPH FINAL part333C WALMART STORES INC TOLNAFTATE 10 mg/g N 20181231 49035-253_3ba229d0-b0cd-4aa4-b1f1-c81b17a743ed 49035-253 HUMAN OTC DRUG Equate Jock Itch CLOTRIMAZOLE CREAM TOPICAL 20160831 OTC MONOGRAPH FINAL part333C WALMART STORES INC CLOTRIMAZOLE 10 mg/g N 20181231 49035-255_7674cdac-bbe1-40fe-8f9b-a9d4795c4262 49035-255 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140430 ANDA ANDA091353 EQUATE (Walmart Stores, Inc.) NAPROXEN SODIUM 220 mg/1 N 20181231 49035-258_e91cb62c-f88d-429f-9857-e2591799028e 49035-258 HUMAN OTC DRUG STOOL SOFTENER Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) DOCUSATE SODIUM 250 mg/1 N 20181231 49035-260_9b53923b-48ad-452c-9950-7a1233fc9646 49035-260 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20160630 ANDA ANDA075209 Wal-Mart LORATADINE 10 mg/1 N 20181231 49035-264_e5daaba9-53ea-451f-aec8-cfb05af8c94b 49035-264 HUMAN OTC DRUG Acne Cleanser Benzoyl peroxide CREAM TOPICAL 20140218 OTC MONOGRAPH FINAL part333D Wal-Mart Stores, Inc BENZOYL PEROXIDE 104 mg/10g N 20181231 49035-267_b10f3ca7-c906-43bf-aaa6-8d765095898e 49035-267 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20170630 OTC MONOGRAPH NOT FINAL part333A EQUATE (Walmart Stores, Inc.) HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 49035-268_927246a0-aa8a-405d-a614-8a1709d32e65 49035-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part356 EQUATE (Walmart Stores, Inc.) HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 49035-271_77c80af2-e95a-4d9f-8e16-9de5138ed302 49035-271 HUMAN OTC DRUG Isopropyl alcohol 50 percent Isopropyl alcohol LIQUID TOPICAL 20170630 OTC MONOGRAPH NOT FINAL part333A EQUATE (Walmart Stores, Inc.) ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 49035-272_2f7be8fd-4888-4f90-9ff7-75be9c758104 49035-272 HUMAN OTC DRUG Isopropyl alcohol 50 percent Isopropyl alcohol LIQUID TOPICAL 20160229 OTC MONOGRAPH NOT FINAL part333A EQUATE (Walmart Stores, Inc.) ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 49035-274_e4dbc9b7-9a0c-4be3-a8bc-0672fe7ab0aa 49035-274 HUMAN OTC DRUG equate aspirin chewable Aspirin TABLET, CHEWABLE ORAL 20030306 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 81 mg/1 N 20181231 49035-275_46698626-4130-4308-a5b2-03663c590e95 49035-275 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part333A EQUATE (Walmart Stores, Inc.) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 49035-276_dcae5efc-fc9f-405b-af33-b4a66b13b8f3 49035-276 HUMAN OTC DRUG Equate Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 49035-277_27143fda-89d8-4064-ad9b-0a6d89692ccd 49035-277 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part333A EQUATE (Walmart Stores, Inc.) ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 49035-278_d5ad830c-64d6-4aa2-bdc6-2895ccccdcf3 49035-278 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen LIQUID ORAL 20151231 OTC MONOGRAPH NOT FINAL part343 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN 500 mg/15mL N 20181231 49035-279_d8caa86b-7315-46f9-9592-40584465b40d 49035-279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores, Inc BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 49035-281_4e61e8e5-d372-4e0c-9202-d79c400dffc6 49035-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090105 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49035-281_ffc861ed-8929-4aad-9067-b584cc965f8e 49035-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090105 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc PYRITHIONE ZINC 1 kg/100L N 20181231 49035-287_618156e8-8fcb-1e2b-e053-2991aa0a230c 49035-287 HUMAN OTC DRUG Pain Relief Equate Lidocaine HCl 4% CREAM TOPICAL 20170529 OTC MONOGRAPH NOT FINAL part348 Walmart LIDOCAINE HYDROCHLORIDE 4 g/100mL N 20181231 49035-288_99b74f42-1e81-47a6-a2e8-a5128f8895f1 49035-288 HUMAN OTC DRUG Pain Reliever Childrens Acetaminophen SUSPENSION ORAL 20150531 OTC MONOGRAPH NOT FINAL part343 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN 160 mg/5mL N 20181231 49035-290_0f30f06f-3888-4bda-8d50-3aee72208b17 49035-290 HUMAN OTC DRUG Hand Citrus Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20161112 OTC MONOGRAPH NOT FINAL part333E Walmart Stores Inc ALCOHOL 35.15 g/60mL N 20181231 49035-292_0f30f06f-3888-4bda-8d50-3aee72208b17 49035-292 HUMAN OTC DRUG Hand Coconut Lime Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20161112 OTC MONOGRAPH NOT FINAL part333E Walmart Stores Inc ALCOHOL 35.15 g/60mL N 20181231 49035-294_ff61459e-b141-42e4-a0eb-b4c6b7fbe85c 49035-294 HUMAN OTC DRUG equate hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20120301 ANDA ANDA091344 Wal-Mart Stores Inc MINOXIDIL 5 g/100g N 20181231 49035-295_3af6617c-2131-49d5-8c3d-99d27cd3c253 49035-295 HUMAN OTC DRUG Medicated Body Powder MENTHOL, ZINC OXIDE POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part348 Walmart Stores Inc MENTHOL; ZINC OXIDE 3; 20 mg/2g; mg/2g N 20181231 49035-296_0474a3ad-f1d7-4e0f-93f6-d756d1959855 49035-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 19980324 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 49035-298_af334373-bc70-48f2-93c6-99dcf2712373 49035-298 HUMAN OTC DRUG EQUATE SPRING SHOWERS ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC. TRICLOSAN 1.5 mg/mL N 20181231 49035-299_e03cb002-64ca-40b5-9dac-ba5a1f40d346 49035-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20080222 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 49035-300_2aa74a15-0f1a-4224-87d9-28389d0102fa 49035-300 HUMAN OTC DRUG Equate beauty road Spectrum SPF30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20160415 OTC MONOGRAPH NOT FINAL part352 Wal-Mart Stores, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE .02; .04; .04; .02 g/29g; g/29g; g/29g; g/29g N 20181231 49035-301_1953b1ce-d3ec-43f6-b995-c0b29e24caaa 49035-301 HUMAN OTC DRUG Blackhead Clearing Scrug Salicylic acid GEL TOPICAL 20070813 OTC MONOGRAPH FINAL part333D Wal Mart SALICYLIC ACID 19.4 mg/g N 20181231 49035-304_192be571-623f-46ba-a512-c540ac0908ee 49035-304 HUMAN OTC DRUG equate nasal original oxymetazoline hydrochloride SPRAY NASAL 19900815 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 49035-306_5ad7f9da-722f-4280-9278-1f41edce0dfb 49035-306 HUMAN OTC DRUG equate clear lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091008 ANDA ANDA090685 Wal-Mart Stores Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 49035-311_08436026-29d7-4ef8-b786-17cfba37efc6 49035-311 HUMAN OTC DRUG Everyday Clean Pyrithione zinc SHAMPOO TOPICAL 20100709 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49035-312_a0391ab1-e9cf-47cb-982d-992bd6a7ddf8 49035-312 HUMAN OTC DRUG Equate Allergy Relief cetirizine hydrochloride TABLET, FILM COATED ORAL 20130725 ANDA ANDA077318 Wal-Mart Stores, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 49035-313_34917c9f-7e95-4883-b40d-4b2507fb2d17 49035-313 HUMAN OTC DRUG Equate Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20131208 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL N 20181231 49035-315_2b88869a-ea80-44af-99a5-ea5bb7ede042 49035-315 HUMAN OTC DRUG Day and Night Cold and Flu Formula acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride KIT 20170823 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-317_e4eb9f24-aed5-497d-b826-378d32edbde5 49035-317 HUMAN OTC DRUG EQUATE MAXIMUM STRENGTH CREAMY DIAPER RASH RELIEF ZINC OXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part347 Wal-Mart Stores, Inc. ZINC OXIDE 181.6 g/454g E 20171231 49035-318_cbe0e0eb-61f7-4ad0-bb0d-df42352e73c7 49035-318 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Metyl salicylate, Thymol RINSE ORAL 19920727 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49035-319_910fe4b9-71b6-46f7-83e3-3c1c518877d6 49035-319 HUMAN OTC DRUG EQUATE CREAMY DIAPER RASH RELIEF ZINC OXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part347 Wal-Mart Stores, Inc. ZINC OXIDE 59.02 g/454g E 20171231 49035-320_911e1680-5fae-4684-a364-20c3fc6ec763 49035-320 HUMAN OTC DRUG EARACHE DROPS ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, and SULFUR LIQUID AURICULAR (OTIC) 20150225 UNAPPROVED HOMEOPATHIC Wal-Mart Stores, Inc ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SULFUR 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 49035-321_6ff87aeb-9c85-49a9-bd3d-b52da4c9bf18 49035-321 HUMAN OTC DRUG Equate Acid Reducer Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20080808 ANDA ANDA077355 Wal-Mart Stores Inc FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 49035-325_dbf82918-9ca8-4679-a967-06b009d3ad58 49035-325 HUMAN OTC DRUG Equate Mucus ER Max Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160422 ANDA ANDA091009 Wal-Mart Stores Inc GUAIFENESIN 1200 mg/1 N 20181231 49035-326_2e638aa7-d40d-4103-a097-9ec00cd203a7 49035-326 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20000901 20181214 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc BISACODYL 5 mg/1 E 20171231 49035-327_f4e234fa-5699-4dd0-b62d-f6a6fec24057 49035-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET, SUGAR COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc BISACODYL 5 mg/1 N 20181231 49035-328_c82cd03c-c82a-46fa-bb08-c68ee810eb7f 49035-328 HUMAN OTC DRUG Equate Sore Throat Phenol SPRAY ORAL 20050628 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores Inc PHENOL 1.4 g/100mL N 20181231 49035-329_5316cc33-37e3-4425-9307-36b219d1e7c0 49035-329 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20141031 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49035-330_084324e8-b2cb-4e04-ac9f-ab3bfcda6cde 49035-330 HUMAN OTC DRUG Nighttime Sleep Aid Alcohol Free Diphenhydramine HCl LIQUID ORAL 20160912 OTC MONOGRAPH FINAL part338 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 49035-331_2b78219a-9934-4b7e-bd2b-530c19eadbd5 49035-331 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20131101 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49035-333_9b8dab1e-cf22-4e33-92a9-577b6d29d231 49035-333 HUMAN OTC DRUG EQUATE MEDICATED DRY AND ITCH Dimethicone, Menthol LOTION TOPICAL 20160216 OTC MONOGRAPH FINAL part347 WAL-MART STORES INC DIMETHICONE; MENTHOL .05; .005 g/g; g/g N 20181231 49035-333_fabbb4fd-251f-49bb-a70e-8013a71e2208 49035-333 HUMAN OTC DRUG Equate Medicated Dry and Itch Dimethicone, Menthol LOTION TOPICAL 20170301 OTC MONOGRAPH FINAL part347 Wal-Mart Stores Inc DIMETHICONE; MENTHOL .05; .005 g/g; g/g N 20181231 49035-334_b4c7ed6b-1630-4432-a9b7-323a3e328d78 49035-334 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 49035-335_4b7e5195-aee6-4eaa-85e6-d3e6befbb9b2 49035-335 HUMAN OTC DRUG equate nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110806 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 49035-338_9f7990b2-05f0-4a2b-8802-400d25b83230 49035-338 HUMAN OTC DRUG Naturally Beaming Avobenzone, Octinoxate, Octisalate LOTION TOPICAL 20100117 OTC MONOGRAPH FINAL part352 Wal-Mart AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL N 20181231 49035-339_86caecd2-4d62-40fe-8c03-20c996858a54 49035-339 HUMAN OTC DRUG Miconazole Nitrate Jock Itch Powder Spray AEROSOL, POWDER TOPICAL 20140225 OTC MONOGRAPH FINAL part333C Wal-Mart Stores, Inc. MICONAZOLE NITRATE 2.6 g/130g N 20181231 49035-341_3ac4798e-11f5-4dec-b9db-3bc66940badf 49035-341 HUMAN OTC DRUG equate athletes foot Miconazole Nitrate SPRAY TOPICAL 20110918 OTC MONOGRAPH FINAL part333C Wal-Mart Stores Inc MICONAZOLE NITRATE 2 g/100g N 20181231 49035-342_381d2adb-8dd7-4ca2-82c7-c8578abea553 49035-342 HUMAN OTC DRUG Equate Liquid Foot Tolnaftate SPRAY TOPICAL 20140701 OTC MONOGRAPH FINAL part333C Wal-Mart Stores, Inc TOLNAFTATE 1 g/150g N 20181231 49035-344_e6edc5dc-7e4f-4b12-b7a4-ca3577b001ed 49035-344 HUMAN OTC DRUG Kids Anticavity Post-Brush Fluoride Rinse AnticavityFluoride MOUTHWASH ORAL 20090820 OTC MONOGRAPH FINAL part355 Wal-Mart Stores, Inc. SODIUM FLUORIDE .0221 kg/100L N 20181231 49035-346_e339218b-50a1-4e48-b7c9-2c0ecb77942d 49035-346 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate TABLET ORAL 20110506 20200911 OTC MONOGRAPH FINAL part335 Wal-Mart Stores Inc BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 49035-348_2ce66ff7-a766-430b-bfea-afe1130d8a17 49035-348 HUMAN OTC DRUG Laxative Sennosides TABLET, SUGAR COATED ORAL 20030102 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc SENNOSIDES 25 mg/1 N 20191231 49035-350_4552c571-a168-4f8a-8d29-71ecfb575425 49035-350 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, EXTENDED RELEASE ORAL 20130805 ANDA ANDA078569 Wal-Mart Stores, Inc ACETAMINOPHEN 650 mg/1 N 20181231 49035-351_ab07997b-6468-4ff8-88ef-080a28bb0dbe 49035-351 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20130909 ANDA ANDA200536 Wal-Mart Stores, Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 49035-352_ea19f0ea-80a7-4134-8a9f-0be933b12394 49035-352 HUMAN OTC DRUG Equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20081014 ANDA ANDA078547 Wal-Mart Stores Inc NICOTINE 2 mg/1 N 20181231 49035-353_eab45a8e-bc72-42d0-86f9-2eaef2b1e7b3 49035-353 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Wal-Mart Stores, Inc RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 49035-354_7f57869d-6897-4b88-917c-935fdccfdbdc 49035-354 HUMAN OTC DRUG Suphedrine PE Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 49035-357_28843406-63d6-4521-b490-47ac8a1a6a77 49035-357 HUMAN OTC DRUG Equate Antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19900615 OTC MONOGRAPH FINAL part331 Wal-Mart Stores Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 49035-359_0fcc3a0a-d237-42b8-a3da-82f7c0d19c22 49035-359 HUMAN OTC DRUG Equate Tussin DM adult Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 19920603 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 49035-362_f991e639-2a6f-c811-aec3-2dac1ccd512e 49035-362 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20171023 ANDA ANDA208150 Walmart FLUTICASONE PROPIONATE 50 ug/1 N 20181231 49035-365_89149fa0-4a76-487c-b442-5797c292876a 49035-365 HUMAN OTC DRUG equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20111004 ANDA ANDA091349 Wal-Mart Stores Inc NICOTINE 2 mg/1 N 20181231 49035-367_953b9e16-f33a-4b8d-9842-692532dc5c66 49035-367 HUMAN OTC DRUG Sleep Aid Nighttime Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49035-368_7c4ac91a-ac45-44d2-8d37-fe5ba64df301 49035-368 HUMAN OTC DRUG equate naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20070427 ANDA ANDA074661 Wal-Mart Stores Inc NAPROXEN SODIUM 220 mg/1 N 20181231 49035-369_7154d454-0f22-4832-a670-c6d3a92b2a5c 49035-369 HUMAN OTC DRUG Equate Hydrocortisone Hydrocortisone CREAM TOPICAL 20090121 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc HYDROCORTISONE 1 g/100g N 20181231 49035-370_f1315a6a-8dc1-4769-81f9-96891c76b462 49035-370 HUMAN OTC DRUG Aspirin regular strength Aspirin TABLET, COATED ORAL 20131025 OTC MONOGRAPH FINAL part343 EQUATE (Walmart Stores, Inc.) ASPIRIN 325 mg/1 N 20181231 49035-371_aa94c73a-cc54-4ec6-a16f-685b4678e0bc 49035-371 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part335 EQUATE (Walmart Stores, Inc.) BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 49035-372_7e74d601-938c-447f-8002-4b045c463379 49035-372 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part335 EQUATE (Wal-Mart Stores, Inc.) BISMUTH SUBSALICYLATE 525 mg/30mL N 20191231 49035-376_3bf05892-7658-4d0f-84c6-59599b0ad3db 49035-376 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20140731 OTC MONOGRAPH NOT FINAL part356 EQUATE (Wal-Mart Stores, Inc.) PHENOL 1.4 g/100mL N 20181231 49035-379_0255259e-8719-4ef7-b84f-e924fd1a204f 49035-379 HUMAN OTC DRUG equate allergy relief Diphenhydramine Hydrochloride SOLUTION ORAL 19900815 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 49035-380_fb049417-d9b3-4151-86d1-f59e4c0ea6ee 49035-380 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20120413 OTC MONOGRAPH FINAL part334 Wal-Mart Stores Inc MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49035-383_35ac039a-3038-4100-b9e7-125fe59cef3c 49035-383 HUMAN OTC DRUG Foaming Hand Wash Antibacterial Triclosan LIQUID TOPICAL 19930319 OTC MONOGRAPH NOT FINAL part333A Wal-Mart TRICLOSAN 6 mg/mL N 20181231 49035-384_fb222ce7-c63b-42d9-8ee1-2b523f03d657 49035-384 HUMAN OTC DRUG Equate Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120829 ANDA ANDA091135 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 49035-386_3900a445-7fea-4559-b9ea-198b55914c42 49035-386 HUMAN OTC DRUG Extra Strength Medicated Body Dimethicone LOTION TOPICAL 19950117 OTC MONOGRAPH FINAL part347 Wal-Mart Stores, Inc DIMETHICONE; MENTHOL 5; .5 kg/100kg; kg/100kg N 20181231 49035-388_f331337f-3ef5-4032-8f00-ce795f216c2a 49035-388 HUMAN OTC DRUG Equate Nasal Oxymetazoline HCl SPRAY NASAL 20070727 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 49035-390_4d54db7a-146d-4c9c-a326-35d17c8c7def 49035-390 HUMAN OTC DRUG Menstrual Complete Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET, FILM COATED ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20191231 49035-393_9cf54cea-dc16-4287-b858-95d302075f35 49035-393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020408 20190708 ANDA ANDA075139 Wal-Mart Stores Inc IBUPROFEN 200 mg/1 E 20171231 49035-395_b6564f84-75ba-4bf3-afc5-d84c1289f644 49035-395 HUMAN OTC DRUG Epsom Salt Epsom Salt GRANULE ORAL; TOPICAL 20161130 OTC MONOGRAPH NOT FINAL part334 EQUATE (Walmart Stores, Inc.) MAGNESIUM SULFATE, UNSPECIFIED 1 g/g N 20181231 49035-396_a976cbbf-f98c-367a-7521-6486f18af0c8 49035-396 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20111104 ANDA ANDA077367 Walmart Stores Inc. FAMOTIDINE 20 mg/1 N 20181231 49035-397_ec9feab4-c7b5-8d4f-1b50-f26820fc5538 49035-397 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium 20.6mg Capsules CAPSULE, DELAYED RELEASE ORAL 20100115 ANDA ANDA078878 Wal-Mart Stores Inc OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 49035-401_b1527f14-c1fa-4ef6-a880-5d1a96c22c12 49035-401 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET ORAL 20130930 OTC MONOGRAPH FINAL part338 EQUATE (Walmart Stores, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49035-402_61fbfd43-f6c5-3f0a-e053-2a91aa0acf06 49035-402 HUMAN OTC DRUG Calaclear Pramoxine Hydrochloride and Zinc Acetate LOTION TOPICAL 20180103 OTC MONOGRAPH FINAL part347 Wal-Mart Stores, Inc. PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20191231 49035-403_b96f1d31-694e-43fe-a08f-5ef41e355495 49035-403 HUMAN OTC DRUG Less Drowsy Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 Wal-Mart Stores Inc MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 49035-404_3693cc0e-7683-b24c-60f9-9b0804b8fd64 49035-404 HUMAN OTC DRUG Ranitidine 150 Ranitidine Hydrochloride Tablets 150mg TABLET, COATED ORAL 20100105 ANDA ANDA078192 Walmart Stores Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 49035-407_a3757879-be7b-4eae-9d35-90086e7b62be 49035-407 HUMAN OTC DRUG equate arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110719 20180220 ANDA ANDA075077 Wal-Mart Stores Inc ACETAMINOPHEN 650 mg/1 N 20181231 49035-408_80049595-b91c-4b64-9652-50647b5776a8 49035-408 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20161231 ANDA ANDA078682 EQUATE (Walmart Stores, Inc.) IBUPROFEN 200 mg/1 N 20181231 49035-411_c75fff46-9e07-4dae-b3f3-91545de28480 49035-411 HUMAN OTC DRUG equate lansoprazole delayed release Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20140505 ANDA ANDA202319 Wal-Mart Stores Inc LANSOPRAZOLE 15 mg/1 N 20181231 49035-412_3b8ba1fb-e7b6-464b-9c7b-d50501f653de 49035-412 HUMAN OTC DRUG Tussin CF Adult Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 49035-413_61928b8a-8c3b-bafd-e053-2a91aa0adcbe 49035-413 HUMAN OTC DRUG Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 20171230 OTC MONOGRAPH FINAL part347 Wal-Mart Stores, Inc. ZINC OXIDE 160 mg/mL N 20181231 49035-416_9efcacef-71fe-4873-9036-d3f3c0ad2c0a 49035-416 HUMAN OTC DRUG Equate Aspirin Aspirin TABLET ORAL 19900215 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 325 mg/1 N 20181231 49035-419_931cbf8d-65f9-485b-b656-4fa7b366e04d 49035-419 HUMAN OTC DRUG Equate Support Advanced Lubricant Polyethylene Glycol, and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20160309 OTC MONOGRAPH FINAL part349 Wal-mart Stores Inc POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 49035-421_6271bb48-74b1-eb57-e053-2991aa0afd1b 49035-421 HUMAN OTC DRUG Equate Effervescent Antacid and Pain Relief Aspirin, Citric Acid, Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20110923 OTC MONOGRAPH FINAL part343 Walmart ASPIRIN; SODIUM BICARBONATE; ANHYDROUS CITRIC ACID 325; 1916; 1000 mg/1; mg/1; mg/1 N 20191231 49035-422_9b16bff6-5f3a-48f2-ab52-fd762cd3ef17 49035-422 HUMAN OTC DRUG equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050308 ANDA ANDA078326 Wal-Mart Stores Inc NICOTINE 4 mg/1 N 20181231 49035-424_0d2f9cb2-8e21-4439-bf83-9beb7645598a 49035-424 HUMAN OTC DRUG Equate Everyday Clean 2in1 Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20170413 OTC MONOGRAPH FINAL part358H Wal-Mart Stores Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49035-424_2adcabc8-9b08-4837-8206-ac6d14a1e61e 49035-424 HUMAN OTC DRUG EQUATE EVERYDAY CLEAN 2IN1 DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20160228 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC PYRITHIONE ZINC 10 mg/mL N 20181231 49035-424_37ed4679-bc5d-40bc-9a57-fe98a3163042 49035-424 HUMAN OTC DRUG EQUATE EVERYDAY CLEAN 2IN1 DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20160710 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC PYRITHIONE ZINC 10 mg/mL N 20181231 49035-424_5f4f8ff8-0faf-4379-a17d-f5f2896dcf3d 49035-424 HUMAN OTC DRUG Equate Everyday Clean 2in1 Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20171214 OTC MONOGRAPH FINAL part358H Wal-mart Stores Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49035-425_695ed806-49ce-40ac-b65d-b2cb6fa64243 49035-425 HUMAN OTC DRUG EQUATE DRY SCALP 2 IN 1 DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20160711 OTC MONOGRAPH FINAL part358H WAL-MART STORE INC PYRITHIONE ZINC 10 mg/mL N 20181231 49035-425_7eabb9d9-56bb-4229-b90e-0be41456d2aa 49035-425 HUMAN OTC DRUG Equate Dry Scalp 2 in 1 Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20170413 OTC MONOGRAPH FINAL part358H Wal-Mart Store Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49035-425_df3bef63-2594-42b2-8b23-942bffab254e 49035-425 HUMAN OTC DRUG EQUATE DRY SCALP 2 IN 1 DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20160228 OTC MONOGRAPH FINAL part358H WAL-MART STORE INC PYRITHIONE ZINC 10 mg/mL N 20181231 49035-426_d4b8edc8-a5f9-4c28-8024-f2264323bb82 49035-426 HUMAN OTC DRUG Equate tioconazole 1 day Tioconazole OINTMENT VAGINAL 20071101 ANDA ANDA075915 Wal-Mart Stores Inc TIOCONAZOLE 6.5 g/100g N 20181231 49035-427_21d7f974-49c1-48e2-baaa-19f95b916192 49035-427 HUMAN OTC DRUG Equate Everyday Clean Pyritione Zinc LIQUID TOPICAL 20170413 OTC MONOGRAPH FINAL part358H Wal-Mart Stores Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49035-427_28ee2704-9b2b-4bc9-8a5d-72d85f442a99 49035-427 HUMAN OTC DRUG Equate Everyday Clean Pyritione Zinc LIQUID TOPICAL 20171214 OTC MONOGRAPH FINAL part358H Wal-mart Stores Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49035-427_f05d9616-5983-49e3-a178-8528bd3078e8 49035-427 HUMAN OTC DRUG EQUATE EVERYDAY CLEAN PYRITIONE ZINC LIQUID TOPICAL 20160225 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC PYRITHIONE ZINC 10 mg/mL N 20181231 49035-428_156bb44a-972a-41cb-afef-3148f37dfb45 49035-428 HUMAN OTC DRUG Equate Dry Scalp Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20170427 OTC MONOGRAPH FINAL part358H Wal-Mart Stores Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49035-428_dee74cd8-4516-4be7-b9d2-8ef43827a6a7 49035-428 HUMAN OTC DRUG EQUATE DRY SCALP DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20160228 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC PYRITHIONE ZINC 10 mg/mL N 20181231 49035-429_582bca14-9ed6-4aa5-96f0-176533351ebd 49035-429 HUMAN OTC DRUG Equate Green Apple 2 in 1 Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20170427 OTC MONOGRAPH FINAL part358H Wal-Mart Stores Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49035-429_e1e44955-67b0-4e85-9afc-db1f87f79150 49035-429 HUMAN OTC DRUG EQUATE GREEN APPLE 2 IN 1 DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20160225 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC PYRITHIONE ZINC 10 mg/mL N 20181231 49035-430_9067e10e-a023-4dd2-866b-854e79993590 49035-430 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20100831 NDA NDA020065 Wal-Mart Stores Inc NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL N 20181231 49035-432_3d6a43a7-970a-45b8-b94a-193d6964336d 49035-432 HUMAN OTC DRUG Equate Classic Spice 2 in 1 Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20170427 OTC MONOGRAPH FINAL part358H Wal-Mart Stores Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49035-432_eaddba37-0f37-43bd-ae43-c3d68a2b7602 49035-432 HUMAN OTC DRUG EQUATE CLASSIC SPICE 2 IN 1 DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20160216 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC PYRITHIONE ZINC 10 mg/mL N 20181231 49035-433_cee047a6-1b55-4bea-8ca8-053529224143 49035-433 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 49035-434_8921ccc9-f6b9-4d8f-ac32-e17dcb3c3e80 49035-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130926 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49035-435_e7411c7d-b6fc-48b5-b093-686163f0a7d4 49035-435 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20150601 OTC MONOGRAPH FINAL part355 Wal-Mart Stores, Inc SODIUM FLUORIDE .2 mg/mL N 20181231 49035-437_31bafec2-a105-4e41-8e53-9913642a8a77 49035-437 HUMAN OTC DRUG Equate Beauty Color Safe Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20161215 OTC MONOGRAPH FINAL part358H Wal-Mart Store Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49035-438_20f3bf67-82d4-4268-8b32-016f9b84f729 49035-438 HUMAN OTC DRUG Ibuprofen Dye-Free Ibuprofen TABLET, FILM COATED ORAL 20040311 ANDA ANDA075139 Wal-Mart Stores Inc IBUPROFEN 200 mg/1 N 20181231 49035-440_53cb48b3-fe37-4096-9a05-103b646cd5d1 49035-440 HUMAN OTC DRUG Equate beauty Color Safe Dandruff Conditioner Pyrithione Zinc LIQUID TOPICAL 20161215 OTC MONOGRAPH FINAL part358H Wal-Mart Store Inc PYRITHIONE ZINC 3 mg/mL N 20181231 49035-442_600a1415-830e-4885-aed8-dc939b8a051f 49035-442 HUMAN OTC DRUG equate Nicotine Nicotine polacrilex GUM, CHEWING ORAL 19900615 ANDA ANDA091354 Wal-Mart Stores Inc NICOTINE 4 mg/1 N 20181231 49035-443_754ecdca-3bec-4bd9-a9b0-6c909cd6ff92 49035-443 HUMAN OTC DRUG Equate Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20160417 ANDA ANDA078104 Wal-Mart Stores Inc TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 49035-447_56bfe266-f9ff-483c-b360-ecac1d21fdb1 49035-447 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050203 20200911 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 80 mg/1 N 20181231 49035-449_712be5c2-baa3-402a-a971-585ebda54ccb 49035-449 HUMAN OTC DRUG Junior Acetaminophen Ages 6-11 Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/1 N 20181231 49035-450_535fd575-1c19-4f26-a890-c8327b31e31e 49035-450 HUMAN OTC DRUG EQUATE ANTI DANDRUFF SALICYLIC ACID SHAMPOO TOPICAL 20160228 OTC MONOGRAPH FINAL part333D WAL-MART STORES INC SALICYLIC ACID 20 mg/mL N 20181231 49035-452_e2d01237-7ff8-4108-9701-fa043876c068 49035-452 HUMAN OTC DRUG Hand Sanitizer Bodycology Ethyl Alcohol GEL TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores, Inc. ALCOHOL 70 mL/100mL E 20171231 49035-453_469b107d-1d87-4bda-b8bf-ab088186f1c3 49035-453 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine HCl TABLET, COATED ORAL 20041206 20181118 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 E 20171231 49035-454_8623d6a5-1ab2-49f9-8bac-55a48f35cfa4 49035-454 HUMAN OTC DRUG Artifical Tears Glycerin and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Wal-Mart Stores Inc GLYCERIN; PROPYLENE GLYCOL 3; 10 mg/mL; mg/mL N 20181231 49035-455_3329cf52-d211-4c01-86b5-cf01dc55406b 49035-455 HUMAN OTC DRUG Pain and Fever Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/1 N 20181231 49035-456_1e88852a-d3f3-4b68-b8d5-08b284f92c14 49035-456 HUMAN OTC DRUG Equate Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070509 ANDA ANDA076777 Wal-Mart Stores Inc NICOTINE 2 mg/1 N 20181231 49035-457_34bcacbd-e0b9-42fd-a9c0-f5491e951c75 49035-457 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20150228 OTC MONOGRAPH NOT FINAL part343 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN 500 mg/1 N 20181231 49035-458_894f1238-e474-49c6-9169-8878b798935d 49035-458 HUMAN OTC DRUG equate allergy relief Cetirizine Hydrochloride TABLET ORAL 20080109 ANDA ANDA078336 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 49035-459_5b9c420d-e4a9-40da-af71-8f2a620b6e26 49035-459 HUMAN OTC DRUG equate nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110802 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 49035-462_9a52ee9a-af79-4e02-9ac9-43aba177398b 49035-462 HUMAN OTC DRUG Suphedrine PE Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 49035-463_27c193da-7e21-4b24-aeff-d9bf3d7e2f9c 49035-463 HUMAN OTC DRUG equate hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140523 OTC MONOGRAPH FINAL part346 Wal-Mart Stores Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 49035-466_a34257cf-d5f7-47f5-a139-ebf2c27b2d5a 49035-466 HUMAN OTC DRUG Daytime Cold and Flu Non drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 49035-467_c56dcfe4-a700-45fe-ace9-bf95237d4806 49035-467 HUMAN OTC DRUG equate aspirin Aspirin TABLET, CHEWABLE ORAL 20030319 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 81 mg/1 N 20181231 49035-469_4082a07e-e501-49d9-a3c4-f283ba3b3dc7 49035-469 HUMAN OTC DRUG equate Daily Facial Moisturizer Broad Spectrum Sunscreen AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20161114 OTC MONOGRAPH NOT FINAL part352 Wal-Mart Stores Inc AVOBENZONE; OCTOCRYLENE 3.54; 11.8 g/118mL; g/118mL N 20181231 49035-480_4e17703f-50ec-4d6a-b63c-c1fabb5d264b 49035-480 HUMAN OTC DRUG equate Age Guard Face Broad Spectrum SPF 110 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20161118 OTC MONOGRAPH NOT FINAL part352 Wal-Mart Stores Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.64; 13.2; 4.4; 8.8; 5.28 g/88mL; g/88mL; g/88mL; g/88mL; g/88mL N 20181231 49035-481_60a5a699-d1f9-0aa2-e053-2a91aa0a6e20 49035-481 HUMAN OTC DRUG Equate Restore Dual Sensitive Lubricant Carboxymethylcellulose sodium, and Glycerin SOLUTION/ DROPS OPHTHALMIC 20160503 OTC MONOGRAPH FINAL part349 Wal-mart Stores, Inc CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 49035-482_78897a22-6536-4526-89e9-bd09f3d03f7f 49035-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20131227 OTC MONOGRAPH FINAL part355 Wal-Mart Stores, Inc SODIUM FLUORIDE .1 mg/mL N 20181231 49035-484_53eee5af-d407-4ff1-aaeb-88a2334a48d0 49035-484 HUMAN OTC DRUG equate acetaminophen Acetaminophen TABLET ORAL 19890915 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 500 mg/1 N 20181231 49035-487_27544130-1ea0-46a5-8dd1-2569ad1b0f75 49035-487 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part347 EQUATE (Walmart Stores, Inc.) DIMETHICONE 125 mg/1 N 20181231 49035-490_c7445973-7ae8-427c-88e2-27827f5c3c37 49035-490 HUMAN OTC DRUG equate naproxen sodium Naproxen Sodium TABLET ORAL 20070502 ANDA ANDA074661 Wal-Mart Stores Inc NAPROXEN SODIUM 220 mg/1 N 20181231 49035-491_3cd1343d-c199-4b89-b204-333e1952c141 49035-491 HUMAN OTC DRUG Pain Reliever Regular Strength Acetaminophen TABLET ORAL 20151031 OTC MONOGRAPH NOT FINAL part343 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN 325 mg/1 N 20181231 49035-494_216ad32d-a063-4506-849c-2e1755b4d044 49035-494 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 EQUATE (Walmart Stores, Inc.) ACETAMINOPHEN 500 mg/1 N 20181231 49035-496_207d2daa-d8d0-4cdb-b841-f78338e0ae10 49035-496 HUMAN OTC DRUG Daily Baby Dimethicone LOTION TOPICAL 20160428 OTC MONOGRAPH FINAL part347 Wal-Mart DIMETHICONE 12.12 mg/mL N 20181231 49035-497_5c1311ff-4ea1-4fae-87a8-c155fa45d7ec 49035-497 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20110831 OTC MONOGRAPH FINAL part358H Wal-Mart COAL TAR 1 g/100mL N 20181231 49035-498_f41273ab-e849-4d00-a138-f7be68d8316d 49035-498 HUMAN OTC DRUG Equate Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130322 ANDA ANDA078912 Wal-Mart Stores Inc GUAIFENESIN 600 mg/1 N 20181231 49035-499_44842382-685e-4133-9cb5-a8068fb46497 49035-499 HUMAN OTC DRUG equate Athletes Foot Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Wal-Mart Stores Inc TOLNAFTATE 10 mg/g N 20181231 49035-501_783b1489-2dce-8619-9a95-2c43dfb4cb61 49035-501 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20161109 ANDA ANDA208150 Walmart FLUTICASONE PROPIONATE 50 ug/1 N 20181231 49035-502_265431d0-8e34-4655-9c3b-30c8181e4a38 49035-502 HUMAN OTC DRUG Suphedrine PE Acetaminophen and Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 49035-503_719ae406-636e-442b-a57d-510767be8da7 49035-503 HUMAN OTC DRUG Severe Cold Multi-Symptom Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 20190126 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 49035-505_6ab43beb-97c1-41c8-bd9a-c7dc61fe1199 49035-505 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20160426 ANDA ANDA206531 Wal-Mart Stores, Inc. FAMOTIDINE 20 mg/1 N 20181231 49035-507_15973213-0e11-4d18-b437-50b0a593cb7b 49035-507 HUMAN OTC DRUG Equate Famotidine Famotidine TABLET ORAL 20160104 ANDA ANDA075400 Wal-Mart Stores Inc FAMOTIDINE 10 mg/1 N 20181231 49035-510_d8ef09f2-fda4-40fd-ac41-f67f6baeb371 49035-510 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20170807 OTC MONOGRAPH FINAL part333B Wal-Mart Stores Inc BACITRACIN ZINC 500 [USP'U]/g N 20181231 49035-511_b423b1f8-afd2-470e-8f92-395f265a269b 49035-511 HUMAN OTC DRUG equate first aid antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140612 OTC MONOGRAPH FINAL part333B Wal-Mart Stores Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 49035-515_02924218-124f-46f5-b241-511b36174b83 49035-515 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Doxylamine succinate , Phenylephrine HCl KIT 20070803 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-515_f540b4e7-ba66-48d0-93a9-eb9ad3f55e67 49035-515 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Doxylamine succinate , Phenylephrine HCl KIT 20110608 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-515_fb1728fd-ad61-4c52-9e4f-578348612f66 49035-515 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Doxylamine succinate , Phenylephrine HCl KIT 20120911 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-516_a41278dd-515c-4cd2-ace2-cfe9d5002db7 49035-516 HUMAN OTC DRUG Equate Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060310 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 49035-517_153bc4ac-427d-426a-9bb8-665487e4b169 49035-517 HUMAN OTC DRUG Equate Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20160302 ANDA ANDA077349 Wal-Mart Stores Inc IBUPROFEN 200 mg/1 N 20181231 49035-518_8fa6b06c-9c4d-4860-8e41-c6082201f852 49035-518 HUMAN OTC DRUG White Petrolatum White Petrolatum JELLY TOPICAL 20090512 OTC MONOGRAPH FINAL part347 Wal-Mart Stores, Inc. PETROLATUM 100 g/100g N 20181231 49035-519_26135c91-15c9-4e7d-8393-601767b6ea0c 49035-519 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 500 mg/1 N 20181231 49035-520_92ed3c1e-4659-468d-9daf-3da0213eeb0a 49035-520 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130115 NDA NDA021855 EQUATE (Walmart Stores, Inc.) LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 49035-521_4a65f733-d32a-4f99-9ad0-67783936c7b2 49035-521 HUMAN OTC DRUG equate ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20111025 ANDA ANDA076359 Wal-Mart Stores Inc IBUPROFEN 100 mg/1 N 20181231 49035-522_4006a712-42b6-432b-a961-ab58eefc7135 49035-522 HUMAN OTC DRUG EQUATE MOISTURIZING DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20151123 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC SELENIUM SULFIDE 10 mg/mL N 20181231 49035-523_ac04f1ce-2345-4692-be3f-4a6dfdbe0c5d 49035-523 HUMAN OTC DRUG Equate Acetaminophen Acetaminophen TABLET ORAL 19890915 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 325 mg/1 N 20181231 49035-525_d1403e49-3eb1-41ed-8d9d-8a7444a26836 49035-525 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19950829 OTC MONOGRAPH FINAL part334 Wal-Mart Stores, Inc MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49035-527_dc2fec61-5929-4d2a-b42d-375dcf3be5d9 49035-527 HUMAN OTC DRUG Sinus Congestion and Pain Severe Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 49035-530_b54afe54-7e47-4438-9785-6dddafdf9185 49035-530 HUMAN OTC DRUG GAS RELIEF Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20130115 OTC MONOGRAPH FINAL part332 EQUATE (Walmart Stores, Inc.) DIMETHICONE 180 mg/1 E 20171231 49035-531_b509547e-ea4b-4c2e-a0c1-7e9b8e031167 49035-531 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 500 mg/1 N 20181231 49035-532_bdca77c0-9725-4f96-9c3c-9d6ef4461631 49035-532 HUMAN OTC DRUG Equate nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070509 ANDA ANDA076779 Wal-Mart Stores Inc NICOTINE 4 mg/1 N 20181231 49035-535_45739013-5582-12bb-e054-00144ff88e88 49035-535 HUMAN OTC DRUG Equate Anticavity Oral Rinse Fluoride LIQUID ORAL 20170105 OTC MONOGRAPH FINAL part355 Wal-Mart Stores, Inc. SODIUM FLUORIDE .021 g/mL N 20181231 49035-536_45c223c9-c1c4-28f0-e054-00144ff88e88 49035-536 HUMAN OTC DRUG Equate Tartar Control Plus Eucalyptol, Menthol, Methyl Salicylate, Thymol LIQUID ORAL 20170105 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/mL; g/mL; g/mL; g/mL N 20181231 49035-537_618083ab-73e1-1a00-e053-2a91aa0a1ccd 49035-537 HUMAN OTC DRUG Earwax Removal Drops Equate Carbamide Peroxide 6.5% LIQUID AURICULAR (OTIC) 20170605 OTC MONOGRAPH FINAL part344 Walmart CARBAMIDE PEROXIDE 6.5 g/100mL N 20181231 49035-543_f2d87c26-8c0f-4fca-8d00-109b297916b8 49035-543 HUMAN OTC DRUG Severe Allergy Plus Sinus Headache Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET, FILM COATED ORAL 20070627 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 49035-544_8c063f9f-bc17-4bbc-85f4-df6c5738b0f7 49035-544 HUMAN OTC DRUG Equate arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000516 ANDA ANDA075077 Wal-Mart Stores Inc ACETAMINOPHEN 650 mg/1 N 20181231 49035-546_b08e0d5e-9895-47ed-995c-9140267d3b5a 49035-546 HUMAN OTC DRUG Equate Acid Reducer Complete Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20080808 ANDA ANDA077355 Wal-Mart Stores Inc FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 49035-548_e79701c8-63ad-4c21-bc0a-1400ebdffcfa 49035-548 HUMAN OTC DRUG equate daytime severe acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140727 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49035-550_b9c4f926-a69f-4003-b667-fda9d43174cd 49035-550 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100706 OTC MONOGRAPH FINAL part332 EQUATE (Walmart Stores, Inc.) DIMETHICONE 125 mg/1 N 20181231 49035-553_9c2e57d3-e04b-42ee-bf58-392454598532 49035-553 HUMAN OTC DRUG Equate Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130813 ANDA ANDA072096 Wal-Mart Stores Inc IBUPROFEN 200 mg/1 N 20181231 49035-554_61cc4d9f-26ea-190a-e053-2991aa0a1d9f 49035-554 HUMAN OTC DRUG Ear Wax Removal System Carbamide Peroxide - 6.50% KIT 20111004 OTC MONOGRAPH FINAL part344 Walmart N 20191231 49035-556_a6e1f9ae-7304-487f-9fde-919b25084005 49035-556 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 49035-558_162aa818-fe45-490f-8e31-f2898a227d41 49035-558 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Acetaminophen and Phenylephrine HCl TABLET ORAL 20080317 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 49035-559_5bb7babd-c700-4c2d-93f8-66ae69b03e76 49035-559 HUMAN OTC DRUG Rapid Release Multi-Symptom Allergy Relief Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate CAPSULE, GELATIN COATED ORAL 20080317 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE 325; 5; 2 mg/1; mg/1; mg/1 N 20181231 49035-560_93b6d8f2-2b76-4449-8e36-e2a817dc21f2 49035-560 HUMAN OTC DRUG Cold Multi-Symptom Daytime Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl TABLET ORAL 20080329 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 49035-561_f3185cc3-0e76-4c8b-9aa4-a3bdbd762a17 49035-561 HUMAN OTC DRUG Multi-Symptom Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130630 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 49035-563_4e8a6822-7ead-4c5a-b394-8a674e3cd9be 49035-563 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 81 mg/1 N 20181231 49035-568_c7ac0431-c154-4033-9264-12f83ac695e1 49035-568 HUMAN OTC DRUG Bodycology Brown Sugar Vanilla Ethyl Alcohol GEL TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores, Inc. ALCOHOL 70 mL/100mL E 20171231 49035-571_d523553a-67ab-4b66-8ea6-155a70b5a821 49035-571 HUMAN OTC DRUG equate allergy relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Wal-Mart Stores Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 49035-576_71e21ef6-0780-4773-a296-f5390403e8d0 49035-576 HUMAN OTC DRUG Oral Antivavity Sodium fluoride MOUTHWASH ORAL 20150108 OTC MONOGRAPH FINAL part355 Wal-Mart Stores, Inc SODIUM FLUORIDE 10.41 mg/mL N 20181231 49035-578_c2615957-3095-46a0-8db4-3b98293c92f5 49035-578 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine HCl TABLET, CHEWABLE ORAL 20081031 20200911 ANDA ANDA078692 Wal-Mart Stores Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 49035-580_f7bb6808-ff55-4e59-930a-22a804a92d59 49035-580 HUMAN OTC DRUG Equate DayTime NiteTime Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140507 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-581_bb2ee889-69f3-496d-a215-54f23017a2ac 49035-581 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20160925 OTC MONOGRAPH FINAL part355 Wal-Mart Stores, Inc SODIUM FLUORIDE .2 mg/mL N 20181231 49035-582_2eadc2b4-7cdd-426c-a39c-89727d73b7ff 49035-582 HUMAN OTC DRUG equate vitamins a and d Lanolin, Petrolatum OINTMENT TOPICAL 20050629 OTC MONOGRAPH FINAL part347 Wal-Mart Stores Inc LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g N 20181231 49035-583_005e7f3d-55d0-48e3-809c-113e709184fc 49035-583 HUMAN OTC DRUG Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20170818 OTC MONOGRAPH FINAL part332 Wal-Mart Stores Inc DIMETHICONE 125 mg/1 N 20181231 49035-585_a1c5ded6-8796-4f12-820f-0177c281506c 49035-585 HUMAN OTC DRUG Ultra Strength Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20171024 OTC MONOGRAPH FINAL part332 Wal-Mart Stores Inc DIMETHICONE 180 mg/1 N 20181231 49035-586_a60352f7-f102-45b6-9011-25c5a34560c6 49035-586 HUMAN OTC DRUG Day Severe Cold and Night Cold and Flu Maximum Strength acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride KIT 20180131 OTC MONOGRAPH FINAL part341 Wal-Mart Stores, Inc. N 20191231 49035-587_26cdc8d4-9249-47eb-be0b-10a16df8ffbe 49035-587 HUMAN OTC DRUG Day and Night Sinus Relief Maximum Strength acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride KIT 20180131 OTC MONOGRAPH FINAL part341 Wal-Mart Stores, Inc. N 20191231 49035-590_97a8b699-ef98-4dcb-9dbd-e576375a8915 49035-590 HUMAN OTC DRUG equate pain and fever acetaminophen SUSPENSION ORAL 19930317 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL N 20181231 49035-591_aa3bcadd-fd45-4f40-9539-6c91bed4c391 49035-591 HUMAN OTC DRUG equate Benzalkonium Chloride LIQUID TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part333E Walmart BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 49035-594_010ff33d-a05f-48d2-99b2-b16a717f0801 49035-594 HUMAN OTC DRUG Equate Lice Treatment Piperonyl butoxide, pyrethrum extract KIT 20160228 OTC MONOGRAPH FINAL part358G Wal-Mart Stores Inc N 20181231 49035-597_6f84c8db-a3df-445b-acba-d8124584236a 49035-597 HUMAN OTC DRUG Equate DayTime NiteTime Severe acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140812 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-599_aee6525f-ffc8-4f6d-9515-4edadf061930 49035-599 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine HCl TABLET, CHEWABLE ORAL 20110425 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20191231 49035-601_ffb1ca02-c0d0-4a06-a6c5-322c4ffa173c 49035-601 HUMAN OTC DRUG parents choice infants ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20170712 ANDA ANDA075217 Wal-Mart Stores Inc IBUPROFEN 50 mg/1.25mL N 20181231 49035-603_e6ea2ab7-eec6-42d2-890e-56f95287e69e 49035-603 HUMAN OTC DRUG Equate DayTime Severe acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20160227 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 49035-604_b5fe0fd0-681e-4c6a-a9ca-c6277ac05d9b 49035-604 HUMAN OTC DRUG equate ibuprofen Ibuprofen TABLET ORAL 19891015 ANDA ANDA072096 Wal-Mart Stores Inc IBUPROFEN 200 mg/1 N 20181231 49035-606_b6725cc2-d26c-472f-a0ec-c316db82747b 49035-606 HUMAN OTC DRUG Equate Adult Tussin DM Max Daytime Nighttime Dextromethorphan HBr, Doxylamine Succinate, Guaifenesin KIT 20170721 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-607_f07c064c-c26d-4ef3-96a3-72b500c1e7f9 49035-607 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, SUGAR COATED ORAL 20130401 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc BISACODYL 5 mg/1 N 20191231 49035-608_1e6ecaab-dc84-484f-88dc-0add1d3cc53b 49035-608 HUMAN OTC DRUG Equate Ranitidine Ranitidine TABLET, FILM COATED ORAL 20120212 ANDA ANDA091429 Wal-Mart Stores Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20191231 49035-610_95e0bc76-6ea1-460c-8e2e-b1549f9feedb 49035-610 HUMAN OTC DRUG MEDICATED DANDRUFF MAXIMUM STRENGTH SELENIUM SULFIDE SHAMPOO TOPICAL 20110819 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC SELENIUM SULFIDE 1 mL/100mL N 20181231 49035-612_b91b37bc-b0ac-45f3-a137-058cfcb9e3b7 49035-612 HUMAN OTC DRUG equate allergy relief Loratadine TABLET ORAL 20070427 ANDA ANDA076301 Wal-Mart Stores Inc LORATADINE 10 mg/1 N 20181231 49035-613_04c0db47-a7f1-494f-8d0f-7df46419c7d9 49035-613 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING BUCCAL 20161001 ANDA ANDA204833 Wal-Mart Stores Inc NICOTINE 4 mg/1 N 20181231 49035-614_8d8aa80b-3a05-4384-b4e0-01826a36236b 49035-614 HUMAN OTC DRUG equate ECZEMA RELIEF COLLOIDAL OATMEAL CREAM TOPICAL 20171023 OTC MONOGRAPH FINAL part347 Wal-Mart Stores Inc OATMEAL 4.52 g/226g N 20181231 49035-616_ad129e4b-bf4d-4ec0-b6f6-e1261cf783b3 49035-616 HUMAN OTC DRUG Multi-Symptom Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49035-618_aca81965-1089-4051-8aae-75ba6b4ccf53 49035-618 HUMAN OTC DRUG EQUATE CRITICAL STRENGTH SELENIUM SULFIDE LIQUID TOPICAL 20120919 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC. SELENIUM SULFIDE 10 mg/mL N 20181231 49035-619_411a4a10-9fd3-49f3-80df-404c8d2f8585 49035-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20100222 OTC MONOGRAPH FINAL part347 Wal-Mart Stores, Inc DIMETHICONE 13.13 mg/mL N 20181231 49035-620_6d42e9f9-17e0-478c-b43c-34b95844dc06 49035-620 HUMAN OTC DRUG EQUATE SELENIUM SULFIDE LIQUID TOPICAL 20130621 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC. SELENIUM SULFIDE 10 mg/mL N 20181231 49035-621_e057a277-3121-4c20-9e2b-df84ce069ec8 49035-621 HUMAN OTC DRUG EQUATE ALOE SELENIUM SULFIDE LIQUID TOPICAL 20131125 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC SELENIUM SULFIDE 10 mg/mL N 20181231 49035-622_97a12fef-d5eb-453c-8c0d-6642f873ec82 49035-622 HUMAN OTC DRUG Equate Anti Itch Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20050629 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 49035-626_44e76a5d-70ee-472e-8ddd-bacb1e2251bd 49035-626 HUMAN OTC DRUG equate first aid antibiotic pain relieving Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20170324 OTC MONOGRAPH FINAL part333B Wal-Mart Stores Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 49035-628_d0ff2795-216c-49c5-9e01-9ed9f584f2ca 49035-628 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20160914 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 49035-633_7c494492-2b52-4f26-bec1-f00fc1c642a2 49035-633 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20161221 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores, Inc., BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 49035-637_5d9e5081-38b5-449c-9d78-e6e2445e3d38 49035-637 HUMAN OTC DRUG Equate Naproxen Sodium Naproxen Sodium TABLET ORAL 20130911 ANDA ANDA074661 Wal-Mart Stores Inc NAPROXEN SODIUM 200 mg/1 N 20181231 49035-641_871f45f3-a82c-4029-a85a-4f85f3741c74 49035-641 HUMAN OTC DRUG Cold and Flu DayTime, NightTime Severe Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl KIT 20150801 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-644_270fe7e6-679c-49d4-b920-7197e9afee4c 49035-644 HUMAN OTC DRUG Equate Purifying Cleanser Benzoyl Peroxide LIQUID TOPICAL 20170202 OTC MONOGRAPH FINAL part333D Wal-Mart Stores Inc BENZOYL PEROXIDE 3 g/120g N 20181231 49035-645_a6d75cf9-05cd-459c-8f95-2fb67bdc85c3 49035-645 HUMAN OTC DRUG Equate Loperamide Hydrochloride loperamide HCl SUSPENSION ORAL 20111007 ANDA ANDA091292 Wal-Mart Stores Inc LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 49035-646_2bde44cc-0f56-44db-8026-ea97b106613f 49035-646 HUMAN OTC DRUG Equate Repairing Benzoyl Peroxide LOTION TOPICAL 20170203 OTC MONOGRAPH FINAL part333D Wal-Mart Stores Inc BENZOYL PEROXIDE 1.5 g/60g N 20181231 49035-647_3dd154fd-c29f-44fe-89ff-d3091d05492d 49035-647 HUMAN OTC DRUG equate ibuprofen Ibuprofen TABLET, COATED ORAL 19890915 ANDA ANDA072096 Wal-Mart Stores Inc IBUPROFEN 200 mg/1 N 20181231 49035-648_95ef1819-edc3-4dda-8514-85b61538cc72 49035-648 HUMAN OTC DRUG Equate Nasal Phenylephrine hydrochloride SPRAY NASAL 20020724 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 49035-650_4c965c03-6962-4768-8b76-68d22c2f35cb 49035-650 HUMAN OTC DRUG Equate Famotidine Famotidine TABLET ORAL 20070502 ANDA ANDA077351 Wal-Mart Stores Inc FAMOTIDINE 20 mg/1 N 20181231 49035-654_2f6f2297-ab31-4250-a014-b4a52f5349fe 49035-654 HUMAN OTC DRUG Sleep Aid NightTime Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH FINAL part338 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49035-655_6181b25a-5c29-daa7-e053-2991aa0abf21 49035-655 HUMAN OTC DRUG Anorectal Equate Lidocaine CREAM TOPICAL 20160416 OTC MONOGRAPH FINAL part346 Walmart LIDOCAINE 5 g/100mL N 20181231 49035-656_fb7fdca8-f7f2-4d10-a0ee-cd431bb6ce5a 49035-656 HUMAN OTC DRUG Equate Day time cold and flu multi symptom relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20060608 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 49035-657_99707059-a693-452b-98bd-78949b712cba 49035-657 HUMAN OTC DRUG Equate Restore Plus Lubricant Eye Carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20130905 OTC MONOGRAPH FINAL part349 Wal-Mart Stores Inc. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 49035-658_a918264e-4cbd-4bfb-9d9c-01ddc04901b6 49035-658 HUMAN OTC DRUG Allergy Relief Dye-Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49035-659_e3d437b2-a454-43c9-8de2-8a1e88b80f10 49035-659 HUMAN OTC DRUG Cold and Flu Non-Drowsy, DayTime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 49035-660_d2c8ec4a-21e4-4378-8b2c-0feef79962a1 49035-660 HUMAN OTC DRUG equate ibuprofen childrens Ibuprofen SUSPENSION ORAL 20100819 ANDA ANDA074937 Wal-Mart Stores Inc IBUPROFEN 100 mg/5mL N 20181231 49035-661_611490eb-15ba-4f32-ab48-a74ea1cf1c24 49035-661 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20171005 ANDA ANDA079174 EQUATE (Wal-Mart Stores, Inc.) IBUPROFEN 200 mg/1 N 20191231 49035-663_baa1dee9-34d6-41af-9489-5c03859d6d18 49035-663 HUMAN OTC DRUG Daytime Sinus Non-Drowsy Acetaminophen, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 20190331 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 49035-664_1da9207d-7701-4ebd-b8aa-80a86f226fb3 49035-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19920915 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49035-666_35ea44c0-cbda-4867-abc6-afdd47ffd336 49035-666 HUMAN OTC DRUG Quick Action Salicylic acid SWAB TOPICAL 20160621 OTC MONOGRAPH FINAL part333D Equate SALICYLIC ACID 2 g/100mL N 20181231 49035-667_80010e07-6cef-44b8-88f6-70ea5558a687 49035-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20120321 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores, Inc MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 49035-668_8bb3dc12-ec8a-4b19-bde3-8eb80b9f0ac5 49035-668 HUMAN OTC DRUG Equate Nite Time Cough Dextromethorphan Hydrobromide, Doxylamine Succinate SOLUTION ORAL 20020724 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 49035-672_e59af2e3-1b55-4f7e-a041-c3086da2f146 49035-672 HUMAN OTC DRUG Sleep Aid NightTime Diphenhydramine HCl TABLET, FILM COATED ORAL 20150724 OTC MONOGRAPH FINAL part338 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49035-675_fa1e496f-740b-4ac2-826d-da68ba89b8af 49035-675 HUMAN OTC DRUG EZ Nite Sleep Aid Diphenhydramine HCl LIQUID ORAL 20151031 OTC MONOGRAPH FINAL part338 EQUATE (Walmart Stores, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 49035-676_a6b82ab4-3473-4ffe-9b06-9d23cedee0d9 49035-676 HUMAN OTC DRUG Womens Gentle Laxative Bisacodyl TABLET ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc BISACODYL 5 mg/1 N 20181231 49035-679_5be57bb8-ac10-41cd-876f-0f8439ad8d85 49035-679 HUMAN OTC DRUG equate first aid antibiotic plus pain relief Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20161212 OTC MONOGRAPH FINAL part333B Wal-Mart Stores Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 49035-688_3b4b668e-03f5-4286-b0a6-67412768c173 49035-688 HUMAN OTC DRUG Age Control Anti-Sagging and Ultra Hydrating Day SPF 15 Ensulizole, Octinoxate CREAM TOPICAL 20131220 OTC MONOGRAPH NOT FINAL part352 Wal-Mart Stores, Inc. ENSULIZOLE; OCTINOXATE 1.7; 7.5 g/100g; g/100g N 20181231 49035-692_8af92641-e4ae-4392-84e1-ed49ef77c921 49035-692 HUMAN OTC DRUG Equate Cool and Heat Menthol, Methyl salicylate CREAM TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 49035-699_fc0a94b2-42b7-427a-8a0e-c26e55740a7e 49035-699 HUMAN OTC DRUG equate ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090415 ANDA ANDA079113 Wal-Mart Stores Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 49035-700_85416cf0-a00b-483b-bdec-8eb907465fdc 49035-700 HUMAN OTC DRUG Equate Pain Relieving Ultra Strength Camphor, Menthol, Methyl salicylate CREAM TOPICAL 20110613 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 10; 300 mg/g; mg/g; mg/g N 20181231 49035-701_2009f2c8-c730-4308-bd07-aad71e3be8f5 49035-701 HUMAN OTC DRUG Equate Antibacterial Citrus Hand Benzalkonium Chloride LIQUID TOPICAL 20170105 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Store Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-702_982ccdb3-2e5e-4d2f-8ae1-2653f6430d61 49035-702 HUMAN OTC DRUG Equate Nicotine Nicotine Polacrilex LOZENGE ORAL 20161007 ANDA ANDA090821 Wal-Mart Stores Inc NICOTINE 4 mg/1 N 20181231 49035-703_1620d33f-9214-8b27-a138-496fe7482f33 49035-703 HUMAN OTC DRUG Budesonide Budesonide SPRAY, METERED NASAL 20160822 ANDA ANDA078949 Walmart BUDESONIDE 32 ug/1 N 20181231 49035-707_19d39dba-1962-412d-831d-2afc14154036 49035-707 HUMAN OTC DRUG equate hydrocortisone Hydrocortisone CREAM TOPICAL 20120313 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc HYDROCORTISONE 1 g/100g N 20181231 49035-709_966f0506-c2d2-4d3c-bd2d-c5a6b1e0a157 49035-709 HUMAN OTC DRUG Infants Gas Relief Drops Simethicone EMULSION ORAL 20171016 OTC MONOGRAPH FINAL part332 Wal-Mart Stores,Inc., DIMETHICONE 20 mg/.3mL N 20181231 49035-710_d9b5f1f5-4951-4afb-8179-df3679f64c79 49035-710 HUMAN OTC DRUG dishwashing chloroxylenol LIQUID TOPICAL 20170114 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores Inc., CHLOROXYLENOL 3.09 1/mL N 20181231 49035-711_5124ce03-5ea9-45e3-a77d-c245f440723c 49035-711 HUMAN OTC DRUG Allergy Relief Cetirizine HCl CAPSULE ORAL 20160531 NDA NDA022429 EQUATE (Walmart Stores, Inc.) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 49035-713_765b764c-4e94-4727-b573-e955bed77cb5 49035-713 HUMAN OTC DRUG dishwashing chloroxylenol LIQUID TOPICAL 20170114 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores Inc., CHLOROXYLENOL 3.09 1/mL N 20181231 49035-719_02dc1f13-2e38-4421-87db-0de757cd1747 49035-719 HUMAN OTC DRUG EQUATE MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20151111 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC SELENIUM SULFIDE 10 mg/mL N 20181231 49035-719_5a5fadcb-1ad8-4f19-97b4-7726af068b13 49035-719 HUMAN OTC DRUG EQUATE MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC SELENIUM SULFIDE 10 mg/mL N 20181231 49035-721_114f6f9d-ac81-4dc5-b280-3ebe8515d450 49035-721 HUMAN OTC DRUG EQUATE LIGHT MOISTURIZERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20151126 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-721_1faaae1a-cd88-4611-8e33-b5e8664f91c4 49035-721 HUMAN OTC DRUG EQUATE LIGHT MOISTURIZERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-721_795f5bad-8294-45fc-bdd5-a43d59bb01db 49035-721 HUMAN OTC DRUG Equate Light Moisturizers Benzalkonium Chloride LIQUID TOPICAL 20170105 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-722_54476d66-4b74-46b9-b4c5-3f0ff41e7ff2 49035-722 HUMAN OTC DRUG Regular Strength Aspirin Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 325 mg/1 N 20181231 49035-723_94a0328c-0922-4818-89db-cde227869ac8 49035-723 HUMAN OTC DRUG EQUATE SPRING SHOWERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-724_1661e148-bdac-415b-9bad-49219a2ca41c 49035-724 HUMAN OTC DRUG EQUATE ANTIBACTERIAL HAND WITH MOISTURIZERS SPRING SHOWERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 49035-730_39db8fde-b49f-44d9-8120-7b0e2e037cca 49035-730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20080303 ANDA ANDA074164 Wal-Mart Stores Inc MICONAZOLE NITRATE 20 mg/g N 20181231 49035-731_139990ff-3c02-46df-b134-671c2599b031 49035-731 HUMAN OTC DRUG Miconazole 3 Combination Pack Miconazole Nitrate KIT 20070611 ANDA ANDA074926 Wal-Mart Stores Inc N 20181231 49035-732_baed9705-7b11-4afa-bb1b-eb66dc2e7ea2 49035-732 HUMAN OTC DRUG Hydrocortisone anti-itch plus Hydrocortisone CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores, Inc. HYDROCORTISONE 10 mg/g N 20181231 49035-733_d2006ad7-92fc-416b-a51c-4debcd084eca 49035-733 HUMAN OTC DRUG Equate NiteTime DayTime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130815 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-734_06ba0f5a-bb7c-4059-8a4f-12432cc5fd03 49035-734 HUMAN OTC DRUG Equate Nicotine Nicotine Polacrilex LOZENGE ORAL 20130214 ANDA ANDA203690 Wal-Mart Stores Inc NICOTINE 2 mg/1 N 20181231 49035-735_2dc67651-84f0-4069-8a14-ed3e4e72f4ee 49035-735 HUMAN OTC DRUG Equate Mucus DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160718 ANDA ANDA091070 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 49035-737_a91746d0-9f09-43e7-b226-e052fd82e847 49035-737 HUMAN OTC DRUG Equate Miconazole 1 Miconazole nitrate KIT 20130812 ANDA ANDA079114 Wal-Mart Stores Inc N 20181231 49035-739_bda67032-54f3-e449-f7a7-c0f3b42c3e74 49035-739 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202194 Wal-Mart Stores Inc LANSOPRAZOLE 15 mg/1 N 20181231 49035-741_ca7f0f68-2862-4265-bf4a-3a89994b4d6b 49035-741 HUMAN OTC DRUG Equate 8HR Arthritis Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160718 ANDA ANDA075077 Wal-Mart Stores Inc ACETAMINOPHEN 650 mg/1 N 20181231 49035-751_23e58f77-c8ed-423f-8967-be736d1c4040 49035-751 HUMAN OTC DRUG Hygienic Cleansing Pad witch hazel SOLUTION RECTAL; TOPICAL 20070301 OTC MONOGRAPH FINAL part346 Wal-Mart Stores Inc WITCH HAZEL .5 mL/mL E 20171231 49035-756_7acc30b4-e946-42cd-8eec-cf15159d478d 49035-756 HUMAN OTC DRUG equate Fiber Therapy Methylcellulose TABLET ORAL 20170830 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores,Inc., METHYLCELLULOSE (4000 MPA.S) 500 mg/1 N 20181231 49035-758_93ca15e9-36b8-4ca5-829c-837ced533fe4 49035-758 HUMAN OTC DRUG Wal-Mart Stores Inc. Equate Fluoride PASTE, DENTIFRICE DENTAL 20140701 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores Inc. SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 49035-761_4a11d025-58f4-070f-e054-00144ff88e88 49035-761 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20160525 ANDA ANDA091353 Wal-Mart Stores, Inc., NAPROXEN SODIUM 220 mg/1 N 20181231 49035-762_4a11d025-58f4-070f-e054-00144ff88e88 49035-762 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20160525 ANDA ANDA091353 Wal-Mart Stores, Inc., NAPROXEN SODIUM 220 mg/1 N 20181231 49035-763_e8afafd3-9bf9-47ce-870f-91b1a5b1096b 49035-763 HUMAN OTC DRUG equate nitetime severe Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140727 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 49035-766_30a51b90-a565-4e38-82ee-b5af29762977 49035-766 HUMAN OTC DRUG Parents Choice Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20170707 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL N 20181231 49035-768_6271b34b-55b4-40a8-e053-2a91aa0acb22 49035-768 HUMAN OTC DRUG Equate Effervescent Cold Relief Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20171102 OTC MONOGRAPH FINAL part341 Walmart ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 N 20191231 49035-771_2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc 49035-771 HUMAN OTC DRUG Maximum Strength Mucus Relief Cold,Flu and Sore Throat Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin ,Phenylephrine HCL LIQUID ORAL 20170906 OTC MONOGRAPH FINAL part341 Wal-Mart Stores,Inc., ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 49035-774_770c0e4f-0eed-4b8c-85a5-761b6a84db62 49035-774 HUMAN OTC DRUG Maximum Strength Mucus Relief Severe Congestion and Cough dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride LIQUID ORAL 20170808 OTC MONOGRAPH FINAL part341 Wal-Mart Stores,Inc., DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 49035-775_0d4ea3ad-6a8f-43d4-b757-0bf5e7abb594 49035-775 HUMAN OTC DRUG Salicylic Acid Astringent LIQUID TOPICAL 20170318 OTC MONOGRAPH FINAL part333D Wal-Mart SALICYLIC ACID 5 mg/mL N 20181231 49035-777_48513168-e54b-41ed-87e9-0b09ed43ef03 49035-777 HUMAN OTC DRUG Pain and Fever Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/1 N 20181231 49035-784_fc388ed7-eedb-1227-e0d1-a4edcbb7302d 49035-784 HUMAN OTC DRUG Allergy Relief Fexofenadine hydrochloride TABLET ORAL 20110413 ANDA ANDA076502 Wal-Mart Stores, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 49035-793_47030da2-557f-3eaa-e054-00144ff88e88 49035-793 HUMAN OTC DRUG Equate Hemorrhoidal Medicated Wipes Witch Hazel CLOTH TOPICAL 20100101 OTC MONOGRAPH FINAL part346 Wal-Mart Stores, Inc. WITCH HAZEL .5 mg/mL N 20181231 49035-798_3eaa6509-63d3-4a6d-84dc-3a67adbb5224 49035-798 HUMAN OTC DRUG equate hair regrowth treatment for men Minoxidil SOLUTION TOPICAL 20110201 ANDA ANDA075598 Wal-Mart Stores Inc MINOXIDIL 3 g/60mL N 20181231 49035-799_d22c08f3-9f50-4f85-985e-50b7eb0d9d1b 49035-799 HUMAN OTC DRUG Equate Tussin DM Max Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20110628 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 49035-800_1e358cc2-eff5-42a8-9263-2771c5241906 49035-800 HUMAN OTC DRUG Equate Ranitidine Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130222 ANDA ANDA091429 Wal-Mart Stores Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20191231 49035-801_0762c3b3-ddd9-41a9-98c0-a0d8dde11c39 49035-801 HUMAN OTC DRUG Island Spring Antibacterial Body Wash with Moisturizers Triclosan SOAP TOPICAL 20100819 OTC MONOGRAPH NOT FINAL part333E Wal-mart Stores Inc. TRICLOSAN .15 mL/100mL N 20181231 49035-802_c6afefe3-7315-4720-b724-6fa5971db89a 49035-802 HUMAN OTC DRUG Equate 8HR Arthritis Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160725 ANDA ANDA075077 Wal-Mart Stores Inc ACETAMINOPHEN 650 mg/1 N 20181231 49035-805_5895a5c0-2665-46fe-99f0-7422d9700254 49035-805 HUMAN OTC DRUG Island Spring Antibacterial Body Wash with Moisturizers Triclosan LIQUID TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E WAL-MART STORES INC TRICLOSAN .15 mL/100mL N 20181231 49035-809_7e41b7a1-c180-4afa-b239-5dda1e6e6147 49035-809 HUMAN OTC DRUG Equate Antibiotic Plus Pain Relief Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20110421 OTC MONOGRAPH FINAL part333B Wal-Mart Stores Inc NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g N 20181231 49035-810_2b67ced0-2bef-48f9-85dd-129dc12c194a 49035-810 HUMAN OTC DRUG Extra Strength Smooth Antacid Antacid Tablets TABLET, CHEWABLE ORAL 20160315 OTC MONOGRAPH FINAL part331 Wal-Mart Stores,Inc., CALCIUM CARBONATE 750 mg/1 N 20181231 49035-810_90f9311b-5340-4841-8302-7e5e3a800fb0 49035-810 HUMAN OTC DRUG Extra Strength Smooth Antacid Antacid Tablets TABLET, CHEWABLE ORAL 20170403 OTC MONOGRAPH FINAL part331 Wal-Mart Stores,Inc., CALCIUM CARBONATE 750 mg/1 N 20181231 49035-812_d0444da2-9a7e-425e-a338-a368723a570a 49035-812 HUMAN OTC DRUG Clotrimazole Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Wal-Mart Stores, Inc. CLOTRIMAZOLE 10 mg/g N 20181231 49035-815_cc93e3b4-adbc-4a2c-b6fc-bf7456ef1656 49035-815 HUMAN OTC DRUG equate Extra Strength Smooth Antacid Assorted Berries Antacid Tablets TABLET, CHEWABLE ORAL 20151028 OTC MONOGRAPH FINAL part331 Wal-Mart Stores,Inc., CALCIUM CARBONATE 750 mg/1 N 20181231 49035-820_24cb1ce8-0489-4128-99f6-e2bafe04cbec 49035-820 HUMAN OTC DRUG Equate Cimetidine Cimetidine TABLET ORAL 20060927 ANDA ANDA075285 Wal-Mart Stores Inc CIMETIDINE 200 mg/1 N 20181231 49035-821_cfe548de-5677-450b-b204-6f96b85ee4ab 49035-821 HUMAN OTC DRUG Acne Scrub Salicylic Acid GEL TOPICAL 20150115 OTC MONOGRAPH FINAL part333D Wal-Mart Stores, Inc SALICYLIC ACID 21 mg/mL N 20181231 49035-823_1b933092-0769-4620-b369-b4174330aef8 49035-823 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride OINTMENT TOPICAL 20100312 20180228 OTC MONOGRAPH FINAL part333B Wal-Mart Stores Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 49035-826_95ad4a1b-9607-4536-9722-93c19d6e7eeb 49035-826 HUMAN OTC DRUG Alcohol Alcohol LIQUID TOPICAL 20170719 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores, Inc ALCOHOL 62 mg/mL N 20181231 49035-827_56843517-e1c8-4acb-9179-40168197c3d8 49035-827 HUMAN OTC DRUG Alcohol Alcohol LIQUID TOPICAL 20170719 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores, Inc ALCOHOL 63 mg/mL N 20181231 49035-829_7d8a2e59-5602-488a-9775-8ff940cffc03 49035-829 HUMAN OTC DRUG Equate Clear Complexion Facial Cleanser Benzoyl Peroxide LIQUID TOPICAL 20161214 OTC MONOGRAPH FINAL part333D Wal-mart Stores Inc BENZOYL PEROXIDE 100 mg/mL N 20181231 49035-830_406a7bc0-c887-4b01-e054-00144ff88e88 49035-830 HUMAN OTC DRUG EQUATE ANTI BACTERIAL HAND SANITIZER Alcohol LIQUID TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores Inc ALCOHOL 62 g/100mL N 20181231 49035-831_407bc783-f17c-4469-e054-00144ff88e88 49035-831 HUMAN OTC DRUG EQUATE ANTI BACTERIAL HAND SANITIZER COCONUT Alcohol LIQUID TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores Inc ALCOHOL 62 g/100mL N 20181231 49035-832_407c20f7-b6a5-417f-e054-00144ff8d46c 49035-832 HUMAN OTC DRUG EQUATE ANTI BACTERIAL HAND SANITIZER STRAWBERRY Alcohol LIQUID TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores Inc ALCOHOL 62 g/100mL N 20181231 49035-833_407fc29e-6ab3-1191-e054-00144ff8d46c 49035-833 HUMAN OTC DRUG EQUATE ANTI BACTERIAL HAND SANITIZER BLACK CHERRY GRAPE Alcohol LIQUID TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores Inc ALCOHOL 62 g/100mL N 20181231 49035-834_407fe0e4-f1fb-4876-e054-00144ff88e88 49035-834 HUMAN OTC DRUG EQUATE ANTI BACTERIAL HAND SANITIZER LEMON Alcohol LIQUID TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores Inc ALCOHOL 62 g/100mL N 20181231 49035-835_40f98ef6-5e1d-6fe9-e054-00144ff88e88 49035-835 HUMAN OTC DRUG EQUATE ANTI BACTERIAL HAND SANITIZER BEACH Alcohol LIQUID TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores Inc ALCOHOL 62 g/100mL N 20181231 49035-836_f69b5374-1c21-484c-9b7f-78e8dfaedda5 49035-836 HUMAN OTC DRUG 2 in 1 Pyrithione zinc SHAMPOO TOPICAL 20120712 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc PYRITHIONE ZINC 10.3 mg/mL N 20181231 49035-850_cdba11da-ae4d-4381-ad64-c6717761af43 49035-850 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20140404 OTC MONOGRAPH FINAL part358H Wal-Mart COAL TAR 1.02 mg/mL N 20181231 49035-851_fc309c75-b95b-442f-8f54-aa7bab554ead 49035-851 HUMAN OTC DRUG Equate antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20021113 OTC MONOGRAPH FINAL part332 Wal-Mart Stores Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 49035-852_d77e5d05-10b4-4088-b79b-7f82ca055ed3 49035-852 HUMAN OTC DRUG equate acid reducer Ranitidine TABLET, FILM COATED ORAL 20120212 ANDA ANDA091429 Wal-Mart Stores Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 49035-854_333ee420-89b5-4798-aa95-4671ef06ada9 49035-854 HUMAN OTC DRUG Equate Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20081014 ANDA ANDA078546 Wal-Mart Stores Inc NICOTINE 4 mg/1 N 20181231 49035-855_35d7c39a-979c-41d6-9523-5020ed434de7 49035-855 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20160910 OTC MONOGRAPH NOT FINAL part356 Wal-Mart Stores, Inc., EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49035-863_c78f9413-32a1-4f80-8c7e-8fab7cf45a86 49035-863 HUMAN OTC DRUG Nighttime Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 Wal-Mart Stores Inc DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 49035-864_6f752a72-b349-4f2a-be85-eaaf85058053 49035-864 HUMAN OTC DRUG equate baby sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20161114 OTC MONOGRAPH NOT FINAL part352 Wal-Mart Stores Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.11; 35.55; 11.85; 23.7; 14.22 g/237mL; g/237mL; g/237mL; g/237mL; g/237mL N 20181231 49035-866_04ec1406-b036-4ea4-beef-1f2214fe1035 49035-866 HUMAN OTC DRUG equate lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070708 OTC MONOGRAPH FINAL part358G Wal-Mart Stores Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL N 20181231 49035-870_d5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc 49035-870 HUMAN OTC DRUG Equate Menthol Pain Relieving menthol PATCH TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc MENTHOL, UNSPECIFIED FORM 50 mg/1 N 20181231 49035-871_1627aad4-ccb2-4a27-bb0f-414da2251723 49035-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20170709 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores, Inc. HYDROGEN PEROXIDE 30 mg/mL N 20181231 49035-872_709688f3-5711-416d-b3fc-3c01cb657b9e 49035-872 HUMAN OTC DRUG Equate Vaporizing camphor, eucalyptus oil, menthol OINTMENT TOPICAL 20070112 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL, UNSPECIFIED FORM 48; 12; 26 mg/g; mg/g; mg/g N 20181231 49035-873_501b408b-cac6-4468-a787-3b318a204aa4 49035-873 HUMAN OTC DRUG equate nicotine Nicotine Polacrilex LOZENGE ORAL 20061215 ANDA ANDA077007 Wal-Mart Stores Inc NICOTINE 4 mg/1 N 20181231 49035-875_a9ab5289-176d-4eb1-be01-96533dffc5df 49035-875 HUMAN OTC DRUG Advanced Healing Petrolatum OINTMENT TOPICAL 20130827 OTC MONOGRAPH FINAL part347 Equate PETROLATUM 340 mg/100g N 20181231 49035-876_3e245b33-b731-4e63-a279-976835012aed 49035-876 HUMAN OTC DRUG Equate Ranitidine Ranitidine TABLET, COATED ORAL 20170519 ANDA ANDA076195 Wal-Mart Stores Inc RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 49035-877_20ffce86-43ac-4aed-8d07-24f06f095138 49035-877 HUMAN OTC DRUG equate beauty Day Cream ENSULIZOLE, OCTINOXATE CREAM TOPICAL 20170625 OTC MONOGRAPH NOT FINAL part352 Wal-Mart Stores, Inc. ENSULIZOLE; OCTINOXATE 1.19; 5.25 g/70g; g/70g N 20181231 49035-881_ef4d82f6-2b77-41cd-9f4a-86ca9906a00d 49035-881 HUMAN OTC DRUG Zinc ZINC GLUCONATE TABLET ORAL 20171030 UNAPPROVED HOMEOPATHIC Wal-Mart Stores,Inc., ZINC GLUCONATE 1 [hp_X]/1 N 20181231 49035-884_80b86068-c5f3-4156-8147-f684fa0e046a 49035-884 HUMAN OTC DRUG equate beauty ALL-DAYMoisturizing Broad SpectrumSPF 15 Sunscreen Octinoxate, Zinc Oxide CREAM TOPICAL 20170723 OTC MONOGRAPH NOT FINAL part352 Wal-Mart Stores, Inc. OCTINOXATE; ZINC OXIDE 10.32; 5.31 g/177mL; g/177mL N 20181231 49035-888_ca3088a7-e1ec-4e69-80d9-fd0051bde938 49035-888 HUMAN OTC DRUG Equate Cool and Heat Extra Strength Menthol PATCH TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc MENTHOL 50 mg/1 N 20181231 49035-889_6e7cd170-b169-4fc0-bc90-f4421bbd9fcd 49035-889 HUMAN OTC DRUG Regular Strength Antacid Antacid TABLET, CHEWABLE ORAL 20170830 OTC MONOGRAPH FINAL part331 Wal-Mart Stores,Inc., CALCIUM CARBONATE 500 mg/1 N 20181231 49035-890_745b2cf5-2599-4383-818b-19fed248a11f 49035-890 HUMAN OTC DRUG Equate Capsaicin Pain Relieving capsaicin PATCH TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part348 Wal-Mart Stores Inc CAPSAICIN 25 mg/1 N 20181231 49035-892_baa7055b-a09d-4824-b4f3-f6b98c7eb326 49035-892 HUMAN OTC DRUG Natural Laxative Sennosides TABLET, FILM COATED ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 Wal-Mart Stores Inc SENNOSIDES 8.6 mg/1 N 20181231 49035-897_9209eb73-0cfe-408b-9caa-7759d5984371 49035-897 HUMAN OTC DRUG equate ibuprofen Ibuprofen SUSPENSION ORAL 19990202 ANDA ANDA074937 Wal-Mart Stores Inc IBUPROFEN 100 mg/5mL N 20191231 49035-898_4e2bb92a-73fc-41ab-a9ad-f795ba1b5669 49035-898 HUMAN OTC DRUG Clean Apple Pyrithione zinc SHAMPOO TOPICAL 20131121 OTC MONOGRAPH FINAL part358H Wal-Mart Stores, Inc PYRITHIONE ZINC 1 g/mL N 20181231 49035-899_5f72c4ad-1c30-41ea-b39c-7f4bb3deced6 49035-899 HUMAN OTC DRUG equate cough dm Dextromethorphan polistirex SUSPENSION ORAL 20150721 ANDA ANDA091135 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 49035-901_65f5222b-b7bd-4b0a-aaa4-fb7ea9389118 49035-901 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49035-902_1b535a28-e355-4e04-88fe-427646ee97fc 49035-902 HUMAN OTC DRUG equate Sugar Free Extra Strength Antacid Orange Cream Flavor Antacid TABLET, CHEWABLE ORAL 20150916 OTC MONOGRAPH FINAL part331 Wal-Mart Stores,Inc., CALCIUM CARBONATE 750 mg/1 N 20181231 49035-905_b5327990-654f-4c1f-8cd4-95470f12d767 49035-905 HUMAN OTC DRUG equate hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20171226 ANDA ANDA091344 Wal-Mart Stores Inc MINOXIDIL 50 mg/g N 20191231 49035-907_bf9f0c98-8a37-47aa-831b-6e5ca6faaf39 49035-907 HUMAN OTC DRUG Equate Severe Cold Multi Symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20160718 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 49035-909_1445a752-fb7d-4172-b87d-64fb5a205a54 49035-909 HUMAN OTC DRUG All Day Moisture Octinoxate, Zinc Oxide LOTION TOPICAL 20090512 OTC MONOGRAPH NOT FINAL part352 Wal-Mart OCTINOXATE; ZINC OXIDE 61.2; 30.6 mg/mL; mg/mL N 20181231 49035-910_e6087f04-20bf-402c-892b-e64f778b0144 49035-910 HUMAN OTC DRUG Extra Strength Gas Relief Simethicone TABLET, CHEWABLE ORAL 20151027 OTC MONOGRAPH FINAL part332 Wal-Mart Stores,Inc., DIMETHICONE 125 mg/1 N 20181231 49035-911_5586d59b-598a-4aa4-b92b-861e1987b0cd 49035-911 HUMAN OTC DRUG Allergy Relief Cetirizine HCl CAPSULE ORAL 20180206 NDA NDA022429 EQUATE (Wal-Mart Stores, Inc.) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20191231 49035-912_c55ea7b7-97be-40e7-b739-b2d9250203d1 49035-912 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Wal-Mart Stores Inc IBUPROFEN 200 mg/1 N 20181231 49035-914_b942d68c-1978-4746-acac-e66791d9f8c5 49035-914 HUMAN OTC DRUG Aspirin Adult Low Dose Aspirin TABLET, COATED ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ASPIRIN 81 mg/1 N 20181231 49035-915_054010e0-d887-4ac8-bfca-ae5a94c9247e 49035-915 HUMAN OTC DRUG Equate omeprazole delayed release acid reducer Omeprazole TABLET, DELAYED RELEASE ORAL 20080227 NDA NDA022032 Wal-Mart Stores Inc OMEPRAZOLE 20 mg/1 N 20181231 49035-917_dbafbbf4-0799-4e05-9df7-64d0a1fc66be 49035-917 HUMAN OTC DRUG EQUATE Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110424 OTC MONOGRAPH FINAL part350 Wal-Mart Stores Inc ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g E 20171231 49035-918_60643e5a-5023-48e9-9dda-a0a10b6eed44 49035-918 HUMAN OTC DRUG EQUATE CLINICAL STRENGTH DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH FINAL part358H WAL-MART STORES INC SELENIUM SULFIDE 10 mg/mL N 20181231 49035-921_aaafc536-f846-4019-a629-b52b3f36e682 49035-921 HUMAN OTC DRUG equate esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20171005 ANDA ANDA207193 Wal-Mart Stores Inc ESOMEPRAZOLE 20 mg/1 N 20181231 49035-928_78d548af-75e8-4ec4-afcc-161b53da9929 49035-928 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride KIT 20080209 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-928_d28be689-47d1-499e-91f1-d93fb16fa985 49035-928 HUMAN OTC DRUG equate daytime nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl KIT 20110310 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-929_59744e3b-54e2-43d4-b436-1a36943bcc2d 49035-929 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49035-931_0f93c8e1-32a8-4b3b-b5a9-1e514350655c 49035-931 HUMAN OTC DRUG Cold Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-934_6ab6ed0d-48fc-441d-a2eb-730ee71d6bbb 49035-934 HUMAN OTC DRUG Quick Action Salicylic acid LIQUID TOPICAL 20170621 OTC MONOGRAPH FINAL part333D Equate SALICYLIC ACID 2 g/100mL N 20181231 49035-936_d150a2d9-02be-4771-bdac-025d16d70d8e 49035-936 HUMAN OTC DRUG EQUATE LUBRICATING EYE CARBOXYMETHYLCELLULOSE SODIUM, AND GLYCERIN SOLUTION/ DROPS OPHTHALMIC 20120401 OTC MONOGRAPH FINAL part349 WAL-MART STORES INC. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 49035-939_a9ec4935-76d0-48ac-9a7a-084e49d64f38 49035-939 HUMAN OTC DRUG EQUATE LUBRICANT EYE POLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOL SOLUTION/ DROPS OPHTHALMIC 20120401 OTC MONOGRAPH FINAL part349 WAL-MART STORES INC POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 49035-940_a25c9e02-e9ee-4d08-8a30-8bf53e64e5af 49035-940 HUMAN OTC DRUG ChlorTabs Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 49035-941_e6d7aebb-1545-458e-b131-178f32b396d6 49035-941 HUMAN OTC DRUG Daily Moisturizer Salicylic acid CREAM TOPICAL 20161219 OTC MONOGRAPH FINAL part333D Wal-Mart Stores, Inc., SALICYLIC ACID 5.05 mg/mL N 20181231 49035-942_800c2957-5686-41ff-b7b0-a2b4078ee543 49035-942 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20170113 OTC MONOGRAPH FINAL part355 Wal-Mart Stores, Inc SODIUM FLUORIDE .2 mg/mL N 20181231 49035-944_8af74c41-0cac-4ca3-9723-9867702b5737 49035-944 HUMAN OTC DRUG equate hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20070925 OTC MONOGRAPH FINAL part346 Wal-Mart Stores Inc GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 49035-946_25f4f564-d9a2-41df-ab23-4c7f8a72c319 49035-946 HUMAN OTC DRUG equate pain and fever infants Acetaminophen SUSPENSION ORAL 20110808 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL N 20181231 49035-947_661249f1-3998-4dbc-ab7b-452a503aa51f 49035-947 HUMAN OTC DRUG Oil Free Acne Wash Salicylic Acid 2% LOTION TOPICAL 20090512 OTC MONOGRAPH FINAL part333D Wal-Mart SALICYLIC ACID 20.6 mg/mL N 20181231 49035-951_62498483-cdcd-47e4-e053-2a91aa0ad8e5 49035-951 HUMAN OTC DRUG Scar Equate Allantoin 0.5% GEL TOPICAL 20150202 OTC MONOGRAPH FINAL part347 Walmart ALLANTOIN .5 g/100g N 20191231 49035-952_48defe93-9837-4691-bb8b-fa9af2ccd5e1 49035-952 HUMAN OTC DRUG Diaper Rash ZINC OXIDE PASTE TOPICAL 20160309 OTC MONOGRAPH FINAL part347 Wal-Mart Stores ZINC OXIDE 532 mg/g N 20191231 49035-954_e49e1492-8990-46b2-8342-9d832f4713d9 49035-954 HUMAN OTC DRUG Antibacterial Citrus Fresh TRICLOSAN SOAP TOPICAL 20100819 OTC MONOGRAPH NOT FINAL part333A Wal-Mart Stores, Inc TRICLOSAN .115 kg/100L N 20181231 49035-956_ff7280e7-804b-423d-add8-54ec2c76fca2 49035-956 HUMAN OTC DRUG Maximum Strength Mucus Relief DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Wal-Mart Stores, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20191231 49035-957_e6c87290-f0e7-4bbb-b15c-154619076db3 49035-957 HUMAN OTC DRUG Equate Nicotine Nicotine Polacrilex LOZENGE ORAL 20130214 ANDA ANDA203690 Wal-Mart Stores Inc NICOTINE 4 mg/1 N 20181231 49035-958_c65dc6ea-42bb-4046-be06-61485681eec0 49035-958 HUMAN OTC DRUG Equate Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130820 ANDA ANDA091135 Wal-Mart Stores Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 49035-959_df391879-2e02-4faa-93f2-89b0c6be7999 49035-959 HUMAN OTC DRUG equate childrens pain and fever Acetaminophen SUSPENSION ORAL 20120124 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 160 mg/5mL N 20181231 49035-964_b9627491-d018-4620-8a19-23c27e6d01fe 49035-964 HUMAN OTC DRUG Equate Flu and Severe Cold and Cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20110711 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 49035-965_af71a539-9112-4339-b53e-9f561f8acf9e 49035-965 HUMAN OTC DRUG Soothing Moisturizing Colloidal oatmeal CREAM TOPICAL 20140422 OTC MONOGRAPH FINAL part347 Wal-Mart Stores, Inc OATMEAL 10.4 mg/g N 20181231 49035-966_13f2c073-8356-4640-99d7-a4a1a1cfc956 49035-966 HUMAN OTC DRUG Anticavity Sodium Fluoride MOUTHWASH ORAL 20100819 OTC MONOGRAPH FINAL part355 Wal-Mart Stores, Inc. SODIUM FLUORIDE .02 kg/100L N 20181231 49035-970_6d2b76a1-8e15-4852-a0ad-114e5b206903 49035-970 HUMAN OTC DRUG Undecylenic Acid Antifungal Pen LIQUID TOPICAL 20170501 OTC MONOGRAPH FINAL part333C Wal-Mart Stores, Inc. UNDECYLENIC ACID 25 mg/1.7mL N 20181231 49035-971_09d81821-d589-4170-a853-b5e3c3ee20d1 49035-971 HUMAN OTC DRUG Anticavity Sodium Fluoride RINSE ORAL 20150114 OTC MONOGRAPH FINAL part355 Wal-Mart Stores, Inc SODIUM FLUORIDE .02 mg/mL N 20181231 49035-975_e7679d4c-d264-4867-ad69-9ae7da9faa80 49035-975 HUMAN OTC DRUG Equate Acetaminophen Acetaminophen TABLET ORAL 20130809 OTC MONOGRAPH NOT FINAL part343 Wal-Mart Stores Inc ACETAMINOPHEN 500 mg/1 N 20181231 49035-978_60e0878f-8697-4b98-8bef-2f07a451178e 49035-978 HUMAN OTC DRUG NiteTime Cold/Flu, Multi-Symptom Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20160309 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 49035-980_c14f096d-ea1f-4539-8ad0-bb9907745cfc 49035-980 HUMAN OTC DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20171016 ANDA ANDA209339 Wal-Mart Stores, Inc. ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg/1 N 20181231 49035-981_ae5c9c57-ae5c-45bc-bc8d-7c4eee830ab2 49035-981 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Wal-Mart Stores Inc DIMENHYDRINATE 50 mg/1 N 20181231 49035-985_f0ecca61-e1cf-4b2e-bf72-9d91ae2a4652 49035-985 HUMAN OTC DRUG Bodycology Sweet Petals Ethyl Alcohol GEL TOPICAL 20110409 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores, Inc. ALCOHOL 70 mL/100mL E 20171231 49035-986_5cdc51ed-9895-4fb7-9201-3a1040c0a1bf 49035-986 HUMAN OTC DRUG Adult Allergy Relief Diphenhydramine Hydrochloride SOLUTION ORAL 20170503 OTC MONOGRAPH FINAL part341 Wal-Mart Stores, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/20mL N 20181231 49035-987_c7e441a0-026e-4646-9b88-a1b9c34f07a5 49035-987 HUMAN OTC DRUG UNDECYLENIC ACID UNDECYLENIC ACID LIQUID TOPICAL 20080601 OTC MONOGRAPH FINAL part333C Wal-Mart Stores Inc UNDECYLENIC ACID 288 mg/mL E 20171231 49035-990_02ba6810-744e-4a2f-9023-17ba1c62a068 49035-990 HUMAN OTC DRUG Undecylenic Acid Antifungal Liquid LIQUID TOPICAL 20140508 OTC MONOGRAPH FINAL part333C Wal-Mart Stores, Inc. UNDECYLENIC ACID .25 g/mL N 20181231 49035-991_994fa270-65bb-4097-b88a-d5ce3c0e1c79 49035-991 HUMAN OTC DRUG No Drip Nasal Mist Nasal Decongestant Severe Congestion oxymetazoline hydrochloride SPRAY NASAL 20170821 OTC MONOGRAPH FINAL part341 Wal-Mart Stores,Inc., OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 49035-992_155414b8-b645-4e4c-99a8-d4998ae50c66 49035-992 HUMAN OTC DRUG Bodycology Vanilla Cupcake Ethyl Alcohol GEL TOPICAL 20110409 OTC MONOGRAPH NOT FINAL part333E Wal-Mart Stores, Inc. ALCOHOL 70 mL/100mL E 20171231 49035-994_3a4c0dad-5705-42f4-b427-9c2852e667a3 49035-994 HUMAN OTC DRUG equate daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20060814 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 49035-995_6db002e0-ae98-4be2-b410-fbfa6fc9e65f 49035-995 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20150930 ANDA ANDA202039 Wal-Mart Stores, Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 49035-996_2054ffa0-57ec-479e-9173-f8c57573d0d9 49035-996 HUMAN OTC DRUG Day and Night Sinus Maximum Strength Acetaminophen, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl KIT 20130630 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-997_8f5be47b-e7fa-4791-9771-a6af8348b9e1 49035-997 HUMAN OTC DRUG Daytime Mucus Relief Severe Cold/Nighttime Mucus Relief Cold and Flu Acetaminophen, Dextromehtorphan HBr, Guaifenesin, Phenylephrine HCl/Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl KIT 20130407 OTC MONOGRAPH FINAL part341 Wal-Mart Stores Inc N 20181231 49035-998_94263d28-2f31-45d5-893d-6483a2265533 49035-998 HUMAN OTC DRUG Equate Nicotine Nicotine Polacrilex LOZENGE ORAL 20061215 ANDA ANDA077007 Wal-Mart Stores Inc NICOTINE 2 mg/1 N 20181231 49121-001_b2e46589-9ed5-4694-a5bc-d683939a640a 49121-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20120401 UNAPPROVED MEDICAL GAS Global Medical LLC OXYGEN 99 L/100L N 20181231 49199-100_6cb26c17-ed7a-4751-af1e-2cc884369890 49199-100 HUMAN OTC DRUG Menticol first aid antiseptic and external analgesic lotion MENTHOL , ALCOHOL LOTION TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Perfumeria Lemaitre S.A. ALCOHOL; MENTHOL .39; 70 mL/100mL; mL/100mL E 20171231 49203-710_057276ba-97a1-4870-ad23-414c873c0fbf 49203-710 HUMAN OTC DRUG Skin Active Intensive Day Octocrylene, Avobenzone, Oxybenzone, and Ensulizole CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part352 Cat Media Pty Ltd OCTOCRYLENE; AVOBENZONE; OXYBENZONE; ENSULIZOLE 49.7; 19.9; 9.9; 9.9 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 49203-730_da4d9b79-878c-4d0b-a03d-5c00ff82eb39 49203-730 HUMAN OTC DRUG Skin Doctors Photo Age Reverse Night Serum Thermus Thermophilus Lysate and Glycerin LIQUID TOPICAL 20100401 UNAPPROVED DRUG OTHER Cat Media Pty Ltd THERMUS THERMOPHILUS LYSATE; GLYCERIN 48.2; 2.54 mg/mL; mg/mL E 20171231 49203-740_856ccb85-0961-4970-ad90-7a569600521d 49203-740 HUMAN OTC DRUG Skin Doctors Photo Age Reverse Thermus Thermophilus Lysate and Glycerin CREAM TOPICAL 20100401 UNAPPROVED DRUG OTHER Cat Media Pty Ltd THERMUS THERMOPHILUS LYSATE; GLYCERIN 46.1; 2.4 mg/mL; mg/mL E 20171231 49204-001_d2eed6c3-559d-4256-a2e9-9df4d75e4da5 49204-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19770701 NDA NDA205712 HARTMAN BROTHERS, INC. OXYGEN 990 mL/L N 20181231 49204-002_9eb5d732-b268-4cb2-ac43-5c379b70dcf7 49204-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19770701 NDA NDA205713 HARTMAN BROTHERS, INC. NITROGEN 990 mL/L N 20181231 49204-003_c9d7c6bd-5368-4450-88af-00cfbd22e944 49204-003 HUMAN PRESCRIPTION DRUG AIR AIR GAS NOT APPLICABLE 20100409 UNAPPROVED MEDICAL GAS HARTMAN BROTHERS, INC AIR 1000 mL/L E 20171231 49204-004_1cbfa9f9-7807-47a5-bb52-016da4229046 49204-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19770701 NDA NDA205712 HARTMAN BROTHERS, INC. OXYGEN 210 mL/L N 20181231 49215-0001_eeb9c4e0-dbbb-4bc8-a06b-07a46600548d 49215-0001 HUMAN OTC DRUG GH Flex Arnica Montana, Carduus Marianus, Hepar Suis, Korean Ginseng, Phosphoricum Acidum, Pituitaria Glandula, LIQUID ORAL 20131024 UNAPPROVED HOMEOPATHIC Safe Anabolic Sciences ARNICA MONTANA; SILYBUM MARIANUM SEED; PORK LIVER; ASIAN GINSENG; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND 3; 1; 6; 1; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49215-0003_8b29aa24-7dd7-4371-a66a-2b70265da275 49215-0003 HUMAN OTC DRUG Winnie Flex Amino Acids, Apis Mellifica, Arnica Montana, Fucus Vesiculosus, Gambogia, Hepar Suis, Phosphoricum Acidum, Pituitaria Glandula suis, Thuja Occidentalis, Thyroidinum, LIQUID ORAL 20131024 20180515 UNAPPROVED HOMEOPATHIC Safe Anabolic Sciences AMINO ACIDS; APIS MELLIFERA; ARNICA MONTANA; FUCUS VESICULOSUS; GAMBOGE; PORK LIVER; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAF; SUS SCROFA THYROID 6; 3; 3; 3; 3; 6; 3; 24; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 49215-0004_790045b3-207a-4c26-a79c-82e55abb9a9d 49215-0004 HUMAN OTC DRUG Test Flex Avena Sativa, Calcarea Carbonica, Damiana, Glandula Suprarenalis Suis, Magnesia Carbonica, Millefolium, Pituitaria Glandula, Sabal Serrulata, Thuja Occidentalis, Urtica Urens, SPRAY ORAL 20140110 UNAPPROVED HOMEOPATHIC Safe Anabolic Sciences AVENA SATIVA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TURNERA DIFFUSA LEAFY TWIG; SUS SCROFA ADRENAL GLAND; MAGNESIUM CARBONATE; ACHILLEA MILLEFOLIUM; BOS TAURUS PITUITARY GLAND; SAW PALMETTO; THUJA OCCIDENTALIS LEAF; URTICA URENS 3; 8; 3; 6; 8; 6; 12; 3; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49215-0005_ca534a61-8a83-41a4-99e4-0d3df504bbe4 49215-0005 HUMAN OTC DRUG Winnie Flex Apis Mellifica, Arnica Montana, Calcarea Carbonica, Fucus Vesiculosus, Gambogia, Hepar Suis, Phosphoricum Acidum, Pituitaria Glandula, Thuja Occidentalis, Thyroidinum Suis, SPRAY ORAL 20140110 20210104 UNAPPROVED HOMEOPATHIC Safe Anabolic Sciences APIS MELLIFERA; ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FUCUS VESICULOSUS; GAMBOGE; PORK LIVER; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAF; SUS SCROFA THYROID 3; 3; 8; 3; 3; 6; 3; 24; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 49215-0006_f6a74f50-a725-4b29-8772-a18e76911ca7 49215-0006 HUMAN OTC DRUG Test Flex Avena Sativa, Calcarea Carbonica, Damiana, Glandula Suprarenalis Suis, Hypophysis Suis, Magnesia Carbonica, Millefolium, Sabal Serrulata, Thuja Occidentalis, Urtica Urens SPRAY ORAL 20170817 UNAPPROVED HOMEOPATHIC Safe Anabolic Sciences AVENA SATIVA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TURNERA DIFFUSA LEAFY TWIG; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; MAGNESIUM CARBONATE; ACHILLEA MILLEFOLIUM; SAW PALMETTO; THUJA OCCIDENTALIS LEAF; URTICA URENS 3; 8; 3; 6; 12; 8; 6; 3; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49215-0007_e32d3280-3092-4997-8a3c-d80cc97f3206 49215-0007 HUMAN OTC DRUG Winnie Flex Apis Mellifica, Arnica Montana, Calcarea Carbonica, Fucus Vesiculosus, Garcinia Cambogia, Hepar Suis, Phosphoricum Acidum, Hypophysis Suis, Thuja Occidentalis, Thyroidinum (Suis) SPRAY ORAL 20170407 UNAPPROVED HOMEOPATHIC Safe Anabolic Sciences APIS MELLIFERA; ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FUCUS VESICULOSUS; GARCINIA CAMBOGIA FRUIT; PORK LIVER; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA THYROID 3; 3; 8; 3; 3; 6; 3; 24; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 49215-0008_ec812dab-ffe3-4081-9f62-b78f588f8b5d 49215-0008 HUMAN OTC DRUG GH Flex Arnica Montana, Carduus Marianus, Hepar Suis, Hypophysis Suis, Panax Ginseng, Phosphoricum Acidum LIQUID ORAL 20170814 UNAPPROVED HOMEOPATHIC Safe Anabolic Sciences ARNICA MONTANA; MILK THISTLE; PORK LIVER; SUS SCROFA PITUITARY GLAND; ASIAN GINSENG; PHOSPHORIC ACID 3; 1; 6; 12; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49221-0025_aa613743-9f0c-4528-b4eb-c8a81cbfab03 49221-0025 HUMAN PRESCRIPTION DRUG MEDICAL AIR AIR GAS RESPIRATORY (INHALATION) 19490101 NDA NDA205765 Strate Welding Supply Co., Inc. OXYGEN 21 L/100L N 20181231 49221-0030_5f04183c-ca74-47a5-927f-2382ec3719a2 49221-0030 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19490101 NDA NDA205767 Strate Welding Supply Co., Inc. OXYGEN 99 L/100L N 20181231 49221-0041_9bd02b8d-e195-4cb9-9353-b17553dacb1d 49221-0041 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19490101 UNAPPROVED MEDICAL GAS Strate Welding Supply Co., Inc. NITROUS OXIDE 99 L/100L N 20181231 49221-0042_ef597192-568b-4c29-8fde-9feed6ddf047 49221-0042 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19490101 NDA NDA205766 Strate Welding Supply Co., Inc. NITROGEN 99 L/100L N 20181231 49221-3000_e399508f-50a4-4834-8649-d96c5b2a8b6f 49221-3000 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19490101 NDA NDA205767 Strate Welding Supply Co., Inc. OXYGEN 99 L/100L N 20181231 49230-188_369a88c0-add6-11e2-9e96-0800200c9a66 49230-188 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 567; 353; 25.7; 15.2 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-188_5d925912-6584-18f2-e053-2a91aa0aa1bf 49230-188 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 567; 392; 25.7; 15.2 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-188_f851a3d0-add7-11e2-9e96-0800200c9a66 49230-188 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 567; 353; 25.7; 15.2 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-191_369a88c0-add6-11e2-9e96-0800200c9a66 49230-191 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 567; 353; 25.7; 15.2 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-191_5d925912-6584-18f2-e053-2a91aa0aa1bf 49230-191 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 567; 392; 25.7; 15.2 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-191_f851a3d0-add7-11e2-9e96-0800200c9a66 49230-191 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 567; 353; 25.7; 15.2 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-194_369a88c0-add6-11e2-9e96-0800200c9a66 49230-194 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 567; 353; 25.7; 15.2 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 49230-194_f851a3d0-add7-11e2-9e96-0800200c9a66 49230-194 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 567; 353; 25.7; 15.2 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 49230-197_369a88c0-add6-11e2-9e96-0800200c9a66 49230-197 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 538; 409; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 49230-197_f851a3d0-add7-11e2-9e96-0800200c9a66 49230-197 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 538; 409; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 49230-200_369a88c0-add6-11e2-9e96-0800200c9a66 49230-200 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 538; 409; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 49230-200_f851a3d0-add7-11e2-9e96-0800200c9a66 49230-200 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 538; 409; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 49230-203_369a88c0-add6-11e2-9e96-0800200c9a66 49230-203 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 538; 409; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 49230-203_f851a3d0-add7-11e2-9e96-0800200c9a66 49230-203 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19841130 NDA NDA018883 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 538; 409; 25.7; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 49230-206_494d8150-addd-11e2-9e96-0800200c9a66 49230-206 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 538; 409; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-206_5d91eba1-9a82-7aad-e053-2a91aa0a22e4 49230-206 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 538; 448; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-206_5d925ac1-5f19-255c-e053-2a91aa0adbe7 49230-206 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 538; 448; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-206_bc39e4d0-addb-11e2-9e96-0800200c9a66 49230-206 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 1.5; 538; 409; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-209_494d8150-addd-11e2-9e96-0800200c9a66 49230-209 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 538; 409; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-209_5d91eba1-9a82-7aad-e053-2a91aa0a22e4 49230-209 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 538; 448; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-209_5d925ac1-5f19-255c-e053-2a91aa0adbe7 49230-209 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 538; 448; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-209_bc39e4d0-addb-11e2-9e96-0800200c9a66 49230-209 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 2.5; 538; 409; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-212_494d8150-addd-11e2-9e96-0800200c9a66 49230-212 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 538; 409; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-212_5d91eba1-9a82-7aad-e053-2a91aa0a22e4 49230-212 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 538; 448; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-212_5d925ac1-5f19-255c-e053-2a91aa0adbe7 49230-212 HUMAN PRESCRIPTION DRUG DELFLEX Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 538; 448; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-212_bc39e4d0-addb-11e2-9e96-0800200c9a66 49230-212 HUMAN PRESCRIPTION DRUG DELFLEX Neutral pH Dextrose Monohydrate, Sodium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Lactate SOLUTION INTRAPERITONEAL 19920819 NDA NDA020171 Fresenius Medical Care North America DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE 4.25; 538; 409; 18.4; 5.08 g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 49230-300_5d8e0e94-b8ec-56db-e053-2991aa0a410f 49230-300 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 20070412 ANDA ANDA078177 Fresenius Medical Care North America SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 49230-530_17e1c611-b419-4666-a221-313f055f9aed 49230-530 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20110127 NDA NDA021135 Fresenius Medical Care North America IRON SUCROSE 20 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 49230-534_17e1c611-b419-4666-a221-313f055f9aed 49230-534 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20081104 NDA NDA021135 Fresenius Medical Care North America IRON SUCROSE 20 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 49230-640_5f4a243c-e5f0-8b71-e053-2991aa0afbe0 49230-640 HUMAN PRESCRIPTION DRUG PhosLo Calcium Acetate CAPSULE ORAL 20010402 NDA NDA021160 Fresenius Medical Care North America CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 49230-643_5f4a4820-4d8c-1715-e053-2991aa0aca5f 49230-643 HUMAN PRESCRIPTION DRUG Phoslyra calcium acetate SOLUTION ORAL 20110415 NDA NDA022581 Fresenius Medical Care North America CALCIUM ACETATE 667 mg/5mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 49230-645_59009145-795f-a7d3-e053-2991aa0a4958 49230-645 HUMAN PRESCRIPTION DRUG Velphoro sucroferric oxyhydroxide TABLET, CHEWABLE ORAL 20131127 NDA NDA205109 Fresenius Medical Care North America FERRIC OXYHYDROXIDE 500 mg/1 N 20181231 49252-001_7ac4b965-1cfa-4d0d-bcac-51ad644ce616 49252-001 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20120601 ANDA ANDA201991 Inventia Healthcare Private Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 49252-007_1902e3e6-2ffb-4ffb-9aab-268ca6a4b776 49252-007 HUMAN PRESCRIPTION DRUG duloxetine duloxetine CAPSULE, DELAYED RELEASE ORAL 20151205 ANDA ANDA202336 Inventia Healthcare Private Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49252-008_1902e3e6-2ffb-4ffb-9aab-268ca6a4b776 49252-008 HUMAN PRESCRIPTION DRUG duloxetine duloxetine CAPSULE, DELAYED RELEASE ORAL 20151205 ANDA ANDA202336 Inventia Healthcare Private Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49252-009_1902e3e6-2ffb-4ffb-9aab-268ca6a4b776 49252-009 HUMAN PRESCRIPTION DRUG duloxetine duloxetine CAPSULE, DELAYED RELEASE ORAL 20151205 ANDA ANDA202336 Inventia Healthcare Private Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49260-611_beb66257-641f-415c-baa9-cf01657cbab3 49260-611 HUMAN OTC DRUG Help I have allergies Loratadine TABLET ORAL 20090701 UNAPPROVED DRUG OTHER Help Remedies, Inc. LORATADINE 10 mg/1 N 20181231 49260-613_0e723c3c-c6bd-46b2-9302-1faec8278095 49260-613 HUMAN OTC DRUG Help I cant Sleep Diphenhydramine TABLET ORAL 20090701 OTC MONOGRAPH FINAL part336 Help Remedies, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 49260-615_62df5f70-2fbf-4620-ab95-09680d33f306 49260-615 HUMAN OTC DRUG Help I Have an Aching Body Ibuprofen TABLET ORAL 20090701 ANDA ANDA075139 Help Remedies, Inc. IBUPROFEN 200 mg/1 N 20181231 49260-710_1073bca3-c40b-4dcc-b8e1-80c90a2dbce1 49260-710 HUMAN OTC DRUG Help I Have a Headache Acetaminophen TABLET ORAL 20120501 OTC MONOGRAPH NOT FINAL part343 Help Remedies, Inc. ACETAMINOPHEN 325 mg/1 E 20171231 49260-716_c8c22f51-49cf-468f-b5da-177cc774cde5 49260-716 HUMAN OTC DRUG Help I Have a Stuffy Nose Phenylephrine TABLET ORAL 20120501 OTC MONOGRAPH FINAL part341 Help Remedies, Inc. PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 E 20171231 49261-001_c2868895-ca73-4929-8511-b09172f9862a 49261-001 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20090815 OTC MONOGRAPH NOT FINAL part333A Conney Safety Products LLC HYDROGEN PEROXIDE 30 mg/mL N 20191231 49261-002_36dc5ec1-48a4-4f2a-bc09-e9be25a66eb9 49261-002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20091005 OTC MONOGRAPH NOT FINAL part333A Conney Safety ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 49281-183_d78e1180-5714-11e1-b7ee-0002a5d5c51b 49281-183 HUMAN PRESCRIPTION DRUG Sklice ivermectin LOTION TOPICAL 20120709 NDA NDA202736 Sanofi Pasteur, Inc IVERMECTIN .585 g/117g Antiparasitic [EPC],Pediculicide [EPC] E 20171231 49281-190_0554e76f-a5a3-4480-998c-62bd4e40c0b8 49281-190 PLASMA DERIVATIVE IMOGAM RABIES-HT HUMAN RABIES VIRUS IMMUNE GLOBULIN INJECTION, SOLUTION INTRAMUSCULAR 19840427 BLA BLA103932 Sanofi Pasteur Inc. HUMAN RABIES VIRUS IMMUNE GLOBULIN 150 [iU]/mL N 20181231 49281-215_088d31f4-c974-4bf8-8142-a4a2942cd0df 49281-215 VACCINE TENIVAC CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20101208 BLA BLA103171 Sanofi Pasteur Inc. CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5; 2 [Lf]/.5mL; [Lf]/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient] N 20181231 49281-225_71231ab7-9fcd-4f58-a860-54a74a480569 49281-225 VACCINE DIPHTHERIA AND TETANUS TOXOIDS ADSORBED CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20100329 BLA BLA103944 Sanofi Pasteur Inc. CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 25; 5 [Lf]/.5mL; [Lf]/.5mL Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient] N 20181231 49281-250_c033f520-a16a-4cad-bf58-3c14b49f73a4 49281-250 VACCINE IMOVAX RABIES RABIES VIRUS STRAIN PM-1503-3M ANTIGEN (PROPIOLACTONE INACTIVATED) and WATER KIT 19800609 BLA BLA103931 Sanofi Pasteur Inc. N 20181231 49281-286_f073f4bd-6a41-4bfb-8961-6006b8dfefa6 49281-286 VACCINE DAPTACEL corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen INJECTION, SUSPENSION INTRAMUSCULAR 20020514 BLA BLA103666 Sanofi Pasteur Inc. CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 15; 5; 10; 5; 3; 5 [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient] N 20181231 49281-400_e55b7408-9107-462a-99ee-576e793d06a1 49281-400 VACCINE Adacel TDaP CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN, and BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN INJECTION, SUSPENSION INTRAMUSCULAR 20050610 BLA BLA125111 Sanofi Pasteur Inc. CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5; 2; 2.5; 5; 3; 5 [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient] N 20181231 49281-401_787ba574-424a-43ca-9336-ebe051bb1698 49281-401 VACCINE FLUZONE High-Dose INFLUENZA A VIRUSA/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20170701 20180630 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) 60; 60; 60 ug/.5mL; ug/.5mL; ug/.5mL N 20181231 49281-417_25e00f2b-d034-4059-ac64-82cb489857a5 49281-417 VACCINE FLUZONE QUADRIVALENT INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20170701 20180630 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL N 20181231 49281-489_0352aee2-4805-4782-89e5-58fa36d1d47f 49281-489 VACCINE MENOMUNE - A/C/Y/W-135 COMBINED Neisseria Meningitidis Group A Capsular Polysaccharide Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Antigen, and Neisseria Meningitidis Group W-135 Capsular Polysaccharide Antigen KIT 19811123 BLA BLA103926 Sanofi Pasteur Inc. N 20181231 49281-489_87b5b316-127e-4524-8c06-876315d52365 49281-489 VACCINE MENOMUNE - A/C/Y/W-135 COMBINED NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE ANTIGEN and NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE ANTIGEN KIT 19811123 BLA BLA103924 Sanofi Pasteur Inc. N 20181231 49281-510_f408b684-659f-4b8d-81e0-ba12b7f1113d 49281-510 VACCINE PENTACEL DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE KIT 20080620 BLA BLA125145 Sanofi Pasteur Inc. N 20181231 49281-517_25e00f2b-d034-4059-ac64-82cb489857a5 49281-517 VACCINE FLUZONE QUADRIVALENT INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20170701 20180630 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) 7.5; 7.5; 7.5; 7.5 ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL N 20181231 49281-545_596df50c-179e-4714-a293-569f75a90e9e 49281-545 VACCINE ActHIB HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN KIT 19930330 BLA BLA103935 Sanofi Pasteur Inc. N 20181231 49281-562_dcaae581-b2b7-453c-975f-c6908401fd17 49281-562 VACCINE QUADRACEL diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20150324 BLA BLA125525 Sanofi Pasteur Inc. CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 15; 5; 20; 20; 3; 5; 40; 8; 32 [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 49281-589_42dae752-40cd-4445-b79f-0fb67bf54ab7 49281-589 VACCINE Menactra NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, and NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN INJECTION, SOLUTION INTRAMUSCULAR 20050114 BLA BLA125089 Sanofi Pasteur Inc. NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4; 4; 4; 4 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 49281-627_25e00f2b-d034-4059-ac64-82cb489857a5 49281-627 VACCINE FLUZONE QUADRIVALENT INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20170701 20180630 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL N 20181231 49281-650_3b63f190-7d2d-4fd7-ab3e-b07378f44d93 49281-650 VACCINE INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20090915 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL E 20171231 49281-712_623d9ae7-c353-454f-85e1-c8cfaa51055d 49281-712 VACCINE FLUZONE INTRADERMAL QUADRIVALENT INFLUENZA A VIRUS A/Michigan/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20170701 20180630 BLA BLA103914 Sanofi Pasteur Inc. INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) 9; 9; 9; 9 ug/.1mL; ug/.1mL; ug/.1mL; ug/.1mL N 20181231 49281-752_ac2ffa6c-45c8-4782-bbe8-44e9822b22fc 49281-752 HUMAN PRESCRIPTION DRUG TUBERSOL Tuberculin Purified Protein Derivative INJECTION, SOLUTION INTRADERMAL 19560815 BLA BLA103941 Sanofi Pasteur Inc. TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU]/.1mL Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [Chemical/Ingredient] N 20181231 49281-790_47d28f8b-8293-4e16-a084-cc7936faa9b7 49281-790 VACCINE Typhim Vi SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN INJECTION, SOLUTION INTRAMUSCULAR 19941128 BLA BLA103936 Sanofi Pasteur Inc. SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN 25 ug/.5mL Inactivated Salmonella Typhi Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Vaccines, Typhoid [Chemical/Ingredient],Vi polysaccharide vaccine, typhoid [Chemical/Ingredient] N 20181231 49281-860_478a4aa9-3609-4cdf-9b30-2072b0d77557 49281-860 VACCINE IPOL POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED), POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED), and POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 19901221 BLA BLA103930 Sanofi Pasteur Inc. POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 40; 8; 32 [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 49281-912_a6571c56-a858-439a-b8fd-16c6ae80d816 49281-912 VACCINE Sodium Chloride Sodium Chloride INJECTION SUBCUTANEOUS 19530522 BLA BLA103915 Sanofi Pasteur Inc. N 20181231 49281-913_a2aba84a-d782-4698-8dd0-21978281cf5a 49281-913 VACCINE STAMARIL YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN KIT 20160927 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Sanofi Pasteur Inc. N 20181231 49281-915_a6571c56-a858-439a-b8fd-16c6ae80d816 49281-915 VACCINE YF-VAX YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION SUBCUTANEOUS 19530522 BLA BLA103915 Sanofi Pasteur Inc. YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN 4.74 [PFU]/.5mL Live Attenuated Yellow Fever Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Yellow Fever Vaccine [Chemical/Ingredient] N 20181231 49283-005_a4dbac5a-4791-44a5-b531-01693316a8cb 49283-005 HUMAN OTC DRUG FAST RELIEF ARTROSAMIN Menthol, Methyl Salicylate CREAM TOPICAL 20131111 OTC MONOGRAPH NOT FINAL part348 Chemco Corporation METHYL SALICYLATE; MENTHOL 12.5; 2.5 g/100g; g/100g E 20171231 49283-006_e54e85df-63d5-4a0c-b3bd-19d17c0605d5 49283-006 HUMAN OTC DRUG FAST RELIEF REUMACETIN Menthol, Methyl Salicylate CREAM TOPICAL 20130826 OTC MONOGRAPH NOT FINAL part348 Chemco Corporation METHYL SALICYLATE; MENTHOL 12.5; 2.5 g/100g; g/100g E 20171231 49283-011_49803f6d-f90e-427c-994a-982d9f344c14 49283-011 HUMAN OTC DRUG Natural 17 Anti-Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20130808 OTC MONOGRAPH FINAL part358H Chemco Corporation PYRITHIONE ZINC 1 g/100mL E 20171231 49283-511_25b9717a-0ab5-4725-afdb-51e5e64a5d1b 49283-511 HUMAN OTC DRUG FAST RELIEF ARTROSAMIN Menthol, Methyl Salicylate CREAM TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part348 Chemco Corporation METHYL SALICYLATE; MENTHOL 7.5; 2.5 g/100g; g/100g E 20171231 49283-512_d46bbf3d-f22e-4515-a883-a7bca00908bc 49283-512 HUMAN OTC DRUG FAST RELIEF REUMACETIN Menthol, Methyl Salicylate CREAM TOPICAL 20130826 OTC MONOGRAPH NOT FINAL part348 Chemco Corporation METHYL SALICYLATE; MENTHOL 7.5; 2.5 g/100g; g/100g E 20171231 49288-0001_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0001 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0002_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0002 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0003_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0003 HUMAN PRESCRIPTION DRUG Alternaria alternata Alternaria alternata INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA .025 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0004_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0004 HUMAN PRESCRIPTION DRUG A Mold Mixture A Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER .0017; .0017; .0017; .0017; .0067; .0067; .0067; .0067; .0067; .0067; .0033; .0033; .0022; .0022; .0011; .0011; .0011; .0011; .0011; .0011; .0067; .0067; .0067; .0067; .0067; .0022 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC] E 20171231 49288-0005_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0005 HUMAN PRESCRIPTION DRUG A Mold Mixture A Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER .0008; .0008; .0008; .0008; .0033; .0033; .0033; .0033; .0033; .0033; .0017; .0017; .0011; .0011; .0006; .0006; .0006; .0006; .0006; .0006; .0033; .0033; .0033; .0033; .0033; .0011 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC] E 20171231 49288-0006_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0006 HUMAN PRESCRIPTION DRUG A Mold Mixture A Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; GEOTRICHUM CANDIDUM; COCHLIOBOLUS SATIVUS; CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA; MUCOR PLUMBEUS; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; SACCHAROMYCES CEREVISIAE; RHIZOPUS STOLONIFER .0004; .0004; .0004; .0004; .0017; .0017; .0017; .0017; .0017; .0017; .0008; .0008; .0006; .0006; .0003; .0003; .0003; .0003; .0003; .0003; .0017; .0017; .0017; .0017; .0017; .0006 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC] E 20171231 49288-0007_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0007 HUMAN PRESCRIPTION DRUG Aspergillus Mixture Aspergillus Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS .0025; .0025; .0025; .0025 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0008_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0008 HUMAN PRESCRIPTION DRUG Aspergillus Mixture Aspergillus Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0009_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0009 HUMAN PRESCRIPTION DRUG Almond Almond INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALMOND .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 49288-0010_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0010 HUMAN PRESCRIPTION DRUG Apple Apple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. APPLE .05 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 49288-0011_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0011 HUMAN PRESCRIPTION DRUG Apricot Apricot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. APRICOT 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0012_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0012 HUMAN PRESCRIPTION DRUG Asparagus Asparagus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPARAGUS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0013_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0013 HUMAN PRESCRIPTION DRUG Avocado Avocado INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AVOCADO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0014_13c9eea1-38b5-472b-b735-a814ca886718 49288-0014 HUMAN PRESCRIPTION DRUG Acacia Pollen Acacia Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740423 BLA BLA102223 Antigen Laboratories, Inc. ACACIA BAILEYANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0015_13c9eea1-38b5-472b-b735-a814ca886718 49288-0015 HUMAN PRESCRIPTION DRUG Smooth (Tag) Alder Smooth (Tag) Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740423 BLA BLA102223 Antigen Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0016_13c9eea1-38b5-472b-b735-a814ca886718 49288-0016 HUMAN PRESCRIPTION DRUG White Alder White Alder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0017_13c9eea1-38b5-472b-b735-a814ca886718 49288-0017 HUMAN PRESCRIPTION DRUG Ash Mixture Ash Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0018_13c9eea1-38b5-472b-b735-a814ca886718 49288-0018 HUMAN PRESCRIPTION DRUG Ash Mixture Ash Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN .01; .01 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0019_13c9eea1-38b5-472b-b735-a814ca886718 49288-0019 HUMAN PRESCRIPTION DRUG Arizona Ash Arizona Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0020_13c9eea1-38b5-472b-b735-a814ca886718 49288-0020 HUMAN PRESCRIPTION DRUG Oregon Ash Oregon Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740423 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS LATIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0021_13c9eea1-38b5-472b-b735-a814ca886718 49288-0021 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0022_13c9eea1-38b5-472b-b735-a814ca886718 49288-0022 HUMAN PRESCRIPTION DRUG White Ash White Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0023_13c9eea1-38b5-472b-b735-a814ca886718 49288-0023 HUMAN PRESCRIPTION DRUG Aspen Pollen Aspen Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS TREMULOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0024_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0024 HUMAN PRESCRIPTION DRUG Western Water Hemp Western Water Hemp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0025_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0025 HUMAN PRESCRIPTION DRUG Careless Weed Careless Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0026_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0026 HUMAN PRESCRIPTION DRUG Wingscale Wingscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATRIPLEX CANESCENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0027_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0027 HUMAN PRESCRIPTION DRUG Shadscale Shadscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATRIPLEX CONFERTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0028_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0028 HUMAN PRESCRIPTION DRUG Lenscale Lenscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0029_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0029 HUMAN PRESCRIPTION DRUG Alfalfa Pollen Alfalfa Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MEDICAGO SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0030_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0030 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0031_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0031 HUMAN PRESCRIPTION DRUG Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FUMIGATUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0032_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0032 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0033_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0033 HUMAN PRESCRIPTION DRUG Aspergillus niger Aspergillus niger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740423 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0034_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0034 HUMAN PRESCRIPTION DRUG Atriplex Mixture Atriplex Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN; ATRIPLEX WRIGHTII POLLEN; ATRIPLEX LENTIFORMIS POLLEN; ATRIPLEX CANESCENS POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0035_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0035 HUMAN PRESCRIPTION DRUG B Mold Mixture B Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. TRICHOTHECIUM ROSEUM; PASSALORA FULVA; COCHLIOBOLUS SPICIFER; MYROTHECIUM VERRUCARIA; HYPOMYCES PERNICIOSUS; NEUROSPORA CRASSA; KHUSKIA ORYZAE; PAECILOMYCES VARIOTII; MICROASCUS BREVICAULIS; COLLETOTRICHUM COCCODES; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071; .0071 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0036_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0036 HUMAN PRESCRIPTION DRUG B Mold Mixture B Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOTHECIUM ROSEUM; PASSALORA FULVA; COCHLIOBOLUS SPICIFER; MYROTHECIUM VERRUCARIA; HYPOMYCES PERNICIOSUS; NEUROSPORA CRASSA; KHUSKIA ORYZAE; PAECILOMYCES VARIOTII; MICROASCUS BREVICAULIS; COLLETOTRICHUM COCCODES; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0037_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0037 HUMAN PRESCRIPTION DRUG B Mold Mixture B Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOTHECIUM ROSEUM; PASSALORA FULVA; COCHLIOBOLUS SPICIFER; MYROTHECIUM VERRUCARIA; HYPOMYCES PERNICIOSUS; NEUROSPORA CRASSA; KHUSKIA ORYZAE; PAECILOMYCES VARIOTII; MICROASCUS BREVICAULIS; COLLETOTRICHUM COCCODES; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII .0018; .0018; .0018; .0018; .0018; .0018; .0018; .0036; .0018; .0018; .0018; .0018; .0018; .0018 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0038_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0038 HUMAN PRESCRIPTION DRUG Botrytis Botrytis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0039_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0039 HUMAN PRESCRIPTION DRUG Botrytis Botrytis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BOTRYTIS CINEREA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0040_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0040 HUMAN PRESCRIPTION DRUG Banana Banana INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BANANA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0041_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0041 HUMAN PRESCRIPTION DRUG Basil Basil INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BASIL .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 49288-0042_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0042 HUMAN PRESCRIPTION DRUG Whole Grain Barley Whole Grain Barley INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BARLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 49288-0043_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0043 HUMAN PRESCRIPTION DRUG Lima Bean Lima Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LIMA BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0044_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0044 HUMAN PRESCRIPTION DRUG Mung Bean Mung Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MUNG BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 49288-0045_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0045 HUMAN PRESCRIPTION DRUG Navy Bean Navy Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0046_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0046 HUMAN PRESCRIPTION DRUG Pinto Bean Pinto Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0047_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0047 HUMAN PRESCRIPTION DRUG Green (Sting) Bean Green (String) Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. STRING BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0048_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0048 HUMAN PRESCRIPTION DRUG Soybean Soybean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SOYBEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0049_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0049 HUMAN PRESCRIPTION DRUG Broccoli Broccoli INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BROCCOLI .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0050_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0050 HUMAN PRESCRIPTION DRUG Brussels Sprout Brussels Sprout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BRUSSELS SPROUT .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0051_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0051 HUMAN PRESCRIPTION DRUG Buckwheat Buckwheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BUCKWHEAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 49288-0052_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0052 HUMAN PRESCRIPTION DRUG Beet Beet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BEET .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0053_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0053 HUMAN PRESCRIPTION DRUG Brazil Nut Meat Brazil Nut Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BRAZIL NUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 49288-0054_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0054 HUMAN PRESCRIPTION DRUG Blackberry Blackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BLACKBERRY .05 g/mL E 20171231 49288-0055_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0055 HUMAN PRESCRIPTION DRUG Blueberry Blueberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BLUEBERRY .05 g/mL E 20171231 49288-0056_13c9eea1-38b5-472b-b735-a814ca886718 49288-0056 HUMAN PRESCRIPTION DRUG Birch Mixture Birch Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN .0083; .0083; .0083; .0083; .0083; .0083 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0057_13c9eea1-38b5-472b-b735-a814ca886718 49288-0057 HUMAN PRESCRIPTION DRUG Birch Mixture Birch Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN .0033; .0033; .0033; .0033; .0033; .0033 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0058_13c9eea1-38b5-472b-b735-a814ca886718 49288-0058 HUMAN PRESCRIPTION DRUG Spring (Water) Birch Spring (Water) Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0059_13c9eea1-38b5-472b-b735-a814ca886718 49288-0059 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0060_13c9eea1-38b5-472b-b735-a814ca886718 49288-0060 HUMAN PRESCRIPTION DRUG Box Elder Box Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0061_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0061 HUMAN PRESCRIPTION DRUG Kidney Bean Kidney Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. KIDNEY BEAN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0062_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0062 HUMAN PRESCRIPTION DRUG Canadian Bluegrass Canadian Bluegrass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POA COMPRESSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0063_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0063 HUMAN PRESCRIPTION DRUG Standardized Bermuda Grass Pollen Standardized Bermuda Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102226 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0064_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0064 HUMAN PRESCRIPTION DRUG Bermuda Grass Smut Bermuda Grass Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO CYNODONTIS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0065_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0065 HUMAN PRESCRIPTION DRUG Bermuda Grass Smut Bermuda Grass Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO CYNODONTIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0066_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0066 HUMAN PRESCRIPTION DRUG Barley Smut Barley Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO NUDA HORDEI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0067_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0067 HUMAN PRESCRIPTION DRUG Annual Bluegrass Annual Bluegrass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0068_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0068 HUMAN PRESCRIPTION DRUG Cheat Brome Grass Cheat Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BROMUS SECALINUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0069_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0069 HUMAN PRESCRIPTION DRUG Smooth Brome Grass Smooth Brome Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0070_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0070 HUMAN PRESCRIPTION DRUG Beef Beef INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BEEF .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 49288-0071_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0071 HUMAN PRESCRIPTION DRUG Bay Leaf Bay Leaf INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LAURUS NOBILIS .05 g/mL E 20171231 49288-0072_13c9eea1-38b5-472b-b735-a814ca886718 49288-0072 HUMAN PRESCRIPTION DRUG Paperbark Birch Paperbark Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770809 BLA BLA102223 Antigen Laboratories, Inc. BETULA PAPYRIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0073_13c9eea1-38b5-472b-b735-a814ca886718 49288-0073 HUMAN PRESCRIPTION DRUG American Beech American Beech INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0074_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0074 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PASPALUM NOTATUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0075_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0075 HUMAN PRESCRIPTION DRUG Bahia Grass Bahia Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0076_13c9eea1-38b5-472b-b735-a814ca886718 49288-0076 HUMAN PRESCRIPTION DRUG Groundsel Tree Groundsel Tree INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0077_13c9eea1-38b5-472b-b735-a814ca886718 49288-0077 HUMAN PRESCRIPTION DRUG Red (River) Birch Red (River) Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. BETULA NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0078_13c9eea1-38b5-472b-b735-a814ca886718 49288-0078 HUMAN PRESCRIPTION DRUG Red (River) Birch Red (River) Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0079_bffa4c39-d658-4a1c-b00a-3f0c411fa524 49288-0079 HUMAN PRESCRIPTION DRUG Bayberry Pollen Bayberry Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MORELLA CERIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0080_13c9eea1-38b5-472b-b735-a814ca886718 49288-0080 HUMAN PRESCRIPTION DRUG White Birch White Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA POPULIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0081_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0081 HUMAN PRESCRIPTION DRUG Sugar Beet Pollen Sugar Beet Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0082_13c9eea1-38b5-472b-b735-a814ca886718 49288-0082 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. POPULUS DELTOIDES POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0083_13c9eea1-38b5-472b-b735-a814ca886718 49288-0083 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0084_13c9eea1-38b5-472b-b735-a814ca886718 49288-0084 HUMAN PRESCRIPTION DRUG Eastern Cottonwood Eastern Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS DELTOIDES POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0085_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0085 HUMAN PRESCRIPTION DRUG Chenopodium Mixture Chenopodium Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM BOTRYS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0086_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0086 HUMAN PRESCRIPTION DRUG Chenopodium Mixture Chenopodium Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM BOTRYS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN .0067; .0067; .0067 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0087_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0087 HUMAN PRESCRIPTION DRUG Cephalosporium Cephalosporium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ACREMONIUM STRICTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0088_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0088 HUMAN PRESCRIPTION DRUG Cephalosporium Cephalosporium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACREMONIUM STRICTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0089_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0089 HUMAN PRESCRIPTION DRUG Cephalosporium Cephalosporium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACREMONIUM STRICTUM .025 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0090_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0090 HUMAN PRESCRIPTION DRUG C Mold Mixture C Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. MYCOCLADUS CORYMBIFERUS; ACROTHECIUM ROBUSTUM; HUMICOLA GRISEA; MICROSPORUM AUDOUINII; MICROSPORUM CANIS; APIOSPORA MONTAGNEI; PHYCOMYCES BLAKESLEEANUS; SPOROTRICHUM PRUINOSUM; STACHYBOTRYS CHARTARUM; SYNCEPHALASTRUM RACEMOSUM; TETRACOCCOSPORIUM PAXIANUM; VERTICILLIUM ALBO-ATRUM .0083; .0083; .0083; .0083; .0083; .0083; .0083; .0083; .0083; .0083; .0083; .0083 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0091_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0091 HUMAN PRESCRIPTION DRUG C Mold Mixture C Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MYCOCLADUS CORYMBIFERUS; ACROTHECIUM ROBUSTUM; HUMICOLA GRISEA; MICROSPORUM AUDOUINII; MICROSPORUM CANIS; APIOSPORA MONTAGNEI; PHYCOMYCES BLAKESLEEANUS; SPOROTRICHUM PRUINOSUM; STACHYBOTRYS CHARTARUM; SYNCEPHALASTRUM RACEMOSUM; TETRACOCCOSPORIUM PAXIANUM; VERTICILLIUM ALBO-ATRUM .0042; .0042; .0042; .0042; .0042; .0042; .0042; .0042; .0042; .0042; .0042; .0042 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0092_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0092 HUMAN PRESCRIPTION DRUG C Mold Mixture C Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MYCOCLADUS CORYMBIFERUS; ACROTHECIUM ROBUSTUM; HUMICOLA GRISEA; MICROSPORUM AUDOUINII; MICROSPORUM CANIS; APIOSPORA MONTAGNEI; PHYCOMYCES BLAKESLEEANUS; SPOROTRICHUM PRUINOSUM; STACHYBOTRYS CHARTARUM; SYNCEPHALASTRUM RACEMOSUM; TETRACOCCOSPORIUM PAXIANUM; VERTICILLIUM ALBO-ATRUM .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0093_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0093 HUMAN PRESCRIPTION DRUG Chaetomium Chaetomium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CHAETOMIUM GLOBOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0094_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0094 HUMAN PRESCRIPTION DRUG Chaetomium Chaetomium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHAETOMIUM GLOBOSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0095_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0095 HUMAN PRESCRIPTION DRUG Cephalothecium Cephalothecium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOTHECIUM ROSEUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0096_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0096 HUMAN PRESCRIPTION DRUG Cladosporium fulvum Cladosporium fulvum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PASSALORA FULVA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0097_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0097 HUMAN PRESCRIPTION DRUG Curvularia Curvularia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SPICIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0098_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0098 HUMAN PRESCRIPTION DRUG Curvularia Curvularia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SPICIFER .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0099_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0099 HUMAN PRESCRIPTION DRUG Corn Corn INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CORN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 49288-0100_afc65820-1d95-4bc6-81a6-ef5ca82cbd81 49288-0100 HUMAN PRESCRIPTION DRUG Coffee Coffee INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARABICA COFFEE BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 49288-0101_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0101 HUMAN PRESCRIPTION DRUG Cabbage Cabbage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CABBAGE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0102_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0102 HUMAN PRESCRIPTION DRUG Cantaloupe Cantaloupe INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANTALOUPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0103_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0103 NON-STANDARDIZED ALLERGENIC Carp Carp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COMMON CARP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0104_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0104 HUMAN PRESCRIPTION DRUG Carrot Carrot INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARROT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0105_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0105 HUMAN PRESCRIPTION DRUG Cashew Nut Meat Cashew Nut Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CASHEW .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 49288-0106_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0106 NON-STANDARDIZED ALLERGENIC Catfish Catfish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. WHITE CATFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0107_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0107 HUMAN PRESCRIPTION DRUG Cauliflower Cauliflower INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CAULIFLOWER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0108_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0108 HUMAN PRESCRIPTION DRUG Celery Celery INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CELERY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0109_80e3a713-b3c2-4981-9f01-d987196bc528 49288-0109 HUMAN PRESCRIPTION DRUG Carob Carob INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CAROB .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 49288-0110_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0110 HUMAN PRESCRIPTION DRUG Cherry Cherry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SWEET CHERRY .05 g/mL E 20171231 49288-0111_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0111 NON-STANDARDIZED ALLERGENIC Clam Clam INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUAHOG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 49288-0112_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0112 HUMAN PRESCRIPTION DRUG Clove Clove INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CLOVE .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 49288-0113_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0113 HUMAN PRESCRIPTION DRUG Chicken Chicken INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHICKEN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 49288-0114_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0114 HUMAN PRESCRIPTION DRUG Cinnamon Cinnamon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CINNAMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0115_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0115 HUMAN PRESCRIPTION DRUG Whole Bean Cacao Whole Bean Cacao INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COCOA BEAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0116_afc65820-1d95-4bc6-81a6-ef5ca82cbd81 49288-0116 HUMAN PRESCRIPTION DRUG Cottonseed Cottonseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COTTON SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 49288-0117_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0117 HUMAN PRESCRIPTION DRUG Cranberry Cranberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CRANBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0118_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0118 HUMAN PRESCRIPTION DRUG Cucumber Cucumber INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CUCUMBER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0119_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0119 NON-STANDARDIZED ALLERGENIC Crab Crab INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20110722 BLA BLA102223 Antigen Laboratories, Inc. OPILIO CRAB .05 g/mL E 20171231 49288-0120_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0120 HUMAN PRESCRIPTION DRUG Coconut Coconut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COCONUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0121_bc075035-e18d-4cbd-be9d-d4d75cb7c2d1 49288-0121 HUMAN PRESCRIPTION DRUG Standardized Cat Hair Standardized Cat Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19921021 BLA BLA103368 Antigen Laboratories, Inc. FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] E 20171231 49288-0122_bc075035-e18d-4cbd-be9d-d4d75cb7c2d1 49288-0122 HUMAN PRESCRIPTION DRUG Standardized Cat Hair Standardized Cat Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19921021 BLA BLA103368 Antigen Laboratories, Inc. FELIS CATUS HAIR 5000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] E 20171231 49288-0123_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0123 HUMAN PRESCRIPTION DRUG Cattle Hair Cattle Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. BOS TAURUS HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] E 20171231 49288-0124_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0124 HUMAN PRESCRIPTION DRUG Cattle Hair Cattle Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BOS TAURUS HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] E 20171231 49288-0125_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0125 HUMAN PRESCRIPTION DRUG Chicken Feather Chicken Feather INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0126_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0126 HUMAN PRESCRIPTION DRUG Chicken Feather Chicken Feather INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER .02 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0127_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0127 HUMAN PRESCRIPTION DRUG Canary Feather Canary Feather INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SERINUS CANARIA FEATHER .02 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Allergens [Chemical/Ingredient] E 20171231 49288-0128_13c9eea1-38b5-472b-b735-a814ca886718 49288-0128 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS ASHEI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0129_13c9eea1-38b5-472b-b735-a814ca886718 49288-0129 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0130_13c9eea1-38b5-472b-b735-a814ca886718 49288-0130 HUMAN PRESCRIPTION DRUG Mountain Cedar Mountain Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS ASHEI POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0131_13c9eea1-38b5-472b-b735-a814ca886718 49288-0131 HUMAN PRESCRIPTION DRUG Redberry Juniper Redberry Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0132_13c9eea1-38b5-472b-b735-a814ca886718 49288-0132 HUMAN PRESCRIPTION DRUG Red Cedar Red Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0133_13c9eea1-38b5-472b-b735-a814ca886718 49288-0133 HUMAN PRESCRIPTION DRUG Salt Cedar Salt Cedar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TAMARIX GALLICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0134_13c9eea1-38b5-472b-b735-a814ca886718 49288-0134 HUMAN PRESCRIPTION DRUG Black Cottonwood Black Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0135_13c9eea1-38b5-472b-b735-a814ca886718 49288-0135 HUMAN PRESCRIPTION DRUG Western Cottonwood Western Cottonwood INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0136_13c9eea1-38b5-472b-b735-a814ca886718 49288-0136 HUMAN PRESCRIPTION DRUG Arizona Cypress Arizona Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0137_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0137 HUMAN PRESCRIPTION DRUG Lambs Quarters Lambs Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM ALBUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0138_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0138 HUMAN PRESCRIPTION DRUG Lambs Quarters Lambs Quarters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0139_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0139 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0140_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0140 HUMAN PRESCRIPTION DRUG Cocklebur Cocklebur INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0141_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0141 HUMAN PRESCRIPTION DRUG Corn Pollen Corn Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0142_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0142 HUMAN PRESCRIPTION DRUG Sweet Clover Mixture Sweet Clover Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740325 BLA BLA102223 Antigen Laboratories, Inc. MELILOTUS ALBUS POLLEN; MELILOTUS OFFICINALIS POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0143_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0143 HUMAN PRESCRIPTION DRUG Corn Smut Corn Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO MAYDIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0144_13c9eea1-38b5-472b-b735-a814ca886718 49288-0144 HUMAN PRESCRIPTION DRUG Bald Cypress Bald Cypress INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TAXODIUM DISTICHUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0145_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0145 HUMAN PRESCRIPTION DRUG Reed Canary Grass Reed Canary Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0146_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0146 HUMAN PRESCRIPTION DRUG Cattail Cattail INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TYPHA LATIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0147_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0147 NON-STANDARDIZED ALLERGENIC Cod Cod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATLANTIC COD .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0148_0c2a583c-28b8-4184-9f4d-9feba1e683c9 49288-0148 HUMAN PRESCRIPTION DRUG American Cockroach American Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PERIPLANETA AMERICANA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0149_0c2a583c-28b8-4184-9f4d-9feba1e683c9 49288-0149 HUMAN PRESCRIPTION DRUG American Cockroach American Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PERIPLANETA AMERICANA .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0150_0c2a583c-28b8-4184-9f4d-9feba1e683c9 49288-0150 HUMAN PRESCRIPTION DRUG American Cockroach American Cockroach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PERIPLANETA AMERICANA .02 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0151_80e3a713-b3c2-4981-9f01-d987196bc528 49288-0151 HUMAN PRESCRIPTION DRUG Currant Currant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RED CURRANT .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 49288-0152_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0152 HUMAN PRESCRIPTION DRUG Caraway Seed Caraway Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARAWAY .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 49288-0153_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0153 HUMAN PRESCRIPTION DRUG Mexican Tea Mexican Tea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0154_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0154 HUMAN PRESCRIPTION DRUG Cotton Linters Cotton Linters INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COTTON FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0155_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0155 HUMAN PRESCRIPTION DRUG Cumin Cumin INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CUMIN .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 49288-0156_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0156 HUMAN PRESCRIPTION DRUG Yellow Sweet Clover Yellow Sweet Clover INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MELILOTUS OFFICINALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0157_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0157 HUMAN PRESCRIPTION DRUG White Sweet Clover White Sweet Clover INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MELILOTUS ALBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0158_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0158 HUMAN PRESCRIPTION DRUG Cladosporium herbarum Cladosporium herbarum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CLADOSPORIUM HERBARUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0159_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0159 HUMAN PRESCRIPTION DRUG Cladosporium herbarum Cladosporium herbarum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CLADOSPORIUM HERBARUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0160_993fabf7-14f0-4417-9838-d1a609628cb5 49288-0160 HUMAN PRESCRIPTION DRUG Cricket Cricket INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACHETA DOMESTICUS .05 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0161_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0161 HUMAN PRESCRIPTION DRUG Date Date INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. DATE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0162_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0162 HUMAN PRESCRIPTION DRUG Dill Seed Dill Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740326 BLA BLA102223 Antigen Laboratories, Inc. DILL .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 49288-0163_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0163 HUMAN PRESCRIPTION DRUG Duck Meat Duck Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. DUCK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 49288-0164_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0164 HUMAN PRESCRIPTION DRUG Dog Hair Dog Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0165_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0165 HUMAN PRESCRIPTION DRUG Dog Hair Dog Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0166_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0166 HUMAN PRESCRIPTION DRUG Dog Hair Dog Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR .02 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0167_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0167 HUMAN PRESCRIPTION DRUG Duck Feather Duck Feather INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 49288-0168_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0168 HUMAN PRESCRIPTION DRUG Deer Hair Deer Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ODOCOILEUS VIRGINIANUS HAIR .05 g/mL E 20171231 49288-0169_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0169 HUMAN PRESCRIPTION DRUG Dandelion Dandelion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TARAXACUM OFFICINALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0170_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0170 HUMAN PRESCRIPTION DRUG Yellow Dock Yellow Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX CRISPUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0171_a1f5af98-9952-4103-a728-433b94a14e0a 49288-0171 HUMAN PRESCRIPTION DRUG Grain Mill Dust Grain Mill Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GRAIN MILL DUST .02 g/mL E 20171231 49288-0172_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0172 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides pteronyssinus Standardized Mite, Dermatophagoides pteronyssinus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19911022 BLA BLA102225 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0173_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0173 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides pteronyssinus Standardized Mite, Dermatophagoides pteronyssinus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920206 BLA BLA102225 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 3000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0174_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0174 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides pteronyssinus Standardized Mite, Dermatophagoides pteronyssinus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19911022 BLA BLA102225 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 5000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0175_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0175 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides farinae Standardized Mite, Dermatophagoides farinae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19911022 BLA BLA102224 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0176_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0176 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides farinae Standardized Mite, Dermatophagoides farinae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920206 BLA BLA102224 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE 3000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0177_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0177 HUMAN PRESCRIPTION DRUG Standardized Mite, Dermatophagoides farinae Standardized Mite, Dermatophagoides farinae INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19911022 BLA BLA102224 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE 5000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0178_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0178 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. RUMEX ACETOSELLA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0179_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0179 HUMAN PRESCRIPTION DRUG Sheep Sorrel Sheep Sorrel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0180_89b69938-05fc-4bd8-9c55-4fb46e9018c7 49288-0180 HUMAN PRESCRIPTION DRUG A. Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HOUSE DUST .1 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] E 20171231 49288-0181_89b69938-05fc-4bd8-9c55-4fb46e9018c7 49288-0181 HUMAN PRESCRIPTION DRUG A. Dust House Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HOUSE DUST .05 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] E 20171231 49288-0182_745162a9-2fdc-4b03-a3bc-32d410b3d9c1 49288-0182 HUMAN PRESCRIPTION DRUG Mixture of Standardized Mites Mixture of Standardized Mites INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19911022 BLA BLA102225 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE 5000; 5000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0183_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0183 HUMAN PRESCRIPTION DRUG Dock/Sorrel Mixture Dock/Sorrel Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20070716 BLA BLA102223 Antigen Laboratories, Inc. RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0184_13c9eea1-38b5-472b-b735-a814ca886718 49288-0184 HUMAN PRESCRIPTION DRUG Elm Mixture Elm Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0185_13c9eea1-38b5-472b-b735-a814ca886718 49288-0185 HUMAN PRESCRIPTION DRUG Elm Mixture Elm Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN .01; .01 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0186_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0186 HUMAN PRESCRIPTION DRUG Epicoccum Epicoccum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0187_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0187 HUMAN PRESCRIPTION DRUG Epicoccum Epicoccum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EPICOCCUM NIGRUM .05 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0188_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0188 HUMAN PRESCRIPTION DRUG Egg White Egg White INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EGG WHITE .05 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 49288-0189_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0189 HUMAN PRESCRIPTION DRUG Whole Egg Whole Egg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EGG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0190_13c9eea1-38b5-472b-b735-a814ca886718 49288-0190 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ULMUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0191_13c9eea1-38b5-472b-b735-a814ca886718 49288-0191 HUMAN PRESCRIPTION DRUG American Elm American Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0192_13c9eea1-38b5-472b-b735-a814ca886718 49288-0192 HUMAN PRESCRIPTION DRUG Chinese (Siberian) Elm Chinese (Siberian) Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ULMUS PUMILA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0193_13c9eea1-38b5-472b-b735-a814ca886718 49288-0193 HUMAN PRESCRIPTION DRUG Eucalyptus Eucalyptus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0194_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0194 HUMAN PRESCRIPTION DRUG Epidermophyton Epidermophyton INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EPIDERMOPHYTON FLOCCOSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0195_13c9eea1-38b5-472b-b735-a814ca886718 49288-0195 HUMAN PRESCRIPTION DRUG Cedar Elm Cedar Elm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0196_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0196 HUMAN PRESCRIPTION DRUG Eggplant Eggplant INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EGGPLANT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0197_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0197 HUMAN PRESCRIPTION DRUG Fusarium oxysporum Fusarium oxysporum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FUSARIUM OXYSPORUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0198_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0198 HUMAN PRESCRIPTION DRUG Fusarium oxysporum Fusarium oxysporum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FUSARIUM OXYSPORUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0199_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0199 HUMAN PRESCRIPTION DRUG Filbert Nut Meat Filbert Nut Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HAZELNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 49288-0200_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0200 NON-STANDARDIZED ALLERGENIC Flounder Flounder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FLOUNDER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0201_afc65820-1d95-4bc6-81a6-ef5ca82cbd81 49288-0201 HUMAN PRESCRIPTION DRUG Flaxseed Flaxseed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FLAX SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 49288-0202_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0202 HUMAN PRESCRIPTION DRUG Franseria Mixture Franseria Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA DUMOSA POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA DELTOIDEA POLLEN; AMBROSIA CONFERTIFLORA POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0203_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0203 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0204_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0204 HUMAN PRESCRIPTION DRUG False Ragweed False Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0205_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0205 HUMAN PRESCRIPTION DRUG Standardized Meadow Fescue Grass Pollen Standardized Meadow Fescue Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102227 Antigen Laboratories, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0206_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0206 HUMAN PRESCRIPTION DRUG Feather Mixture Feather Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .0333; .0333; .0333 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 49288-0207_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0207 HUMAN PRESCRIPTION DRUG Feather Mixture Feather Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 49288-0208_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0208 HUMAN PRESCRIPTION DRUG Rabbit Bush Rabbit Bush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0209_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0209 HUMAN PRESCRIPTION DRUG Dog Fennel Dog Fennel INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0210_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0210 HUMAN PRESCRIPTION DRUG Number Four Mold Mixture Number Four Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI .0125; .0031; .0031; .0031; .0031; .0125; .0021; .0021; .0021; .0021; .0021; .0021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0211_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0211 HUMAN PRESCRIPTION DRUG Grain Smut Mixture Grain Smut Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI .025; .025; .025; .025 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0212_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0212 HUMAN PRESCRIPTION DRUG Grain Smut Mixture Grain Smut Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970909 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0213_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0213 HUMAN PRESCRIPTION DRUG Grain Smut Mixture Grain Smut Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970909 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI .005; .005; .005; .005 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0214_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0214 HUMAN PRESCRIPTION DRUG Grass Smut Mixture Grass Smut Mixture INJECTION, SOLUTION SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM .05; .05 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0215_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0215 HUMAN PRESCRIPTION DRUG Grass Smut Mixture Grass Smut Mixture INJECTION, SOLUTION SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM .025; .025 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0216_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0216 HUMAN PRESCRIPTION DRUG Grass Smut Mixture Grass Smut Mixture INJECTION, SOLUTION SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM .01; .01 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0217_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0217 HUMAN PRESCRIPTION DRUG Gliocladium Gliocladium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MYROTHECIUM VERRUCARIA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0218_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0218 HUMAN PRESCRIPTION DRUG Garlic Garlic INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GARLIC .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0219_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0219 HUMAN PRESCRIPTION DRUG Ginger Ginger INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GINGER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 49288-0220_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0220 HUMAN PRESCRIPTION DRUG Goose Meat Goose Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GOOSE .05 g/mL E 20171231 49288-0221_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0221 HUMAN PRESCRIPTION DRUG Concord Grape Concord Grape INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CONCORD GRAPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0222_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0222 HUMAN PRESCRIPTION DRUG Grapefruit Grapefruit INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GRAPEFRUIT 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0223_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0223 HUMAN PRESCRIPTION DRUG Grapefruit Grapefruit INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GRAPEFRUIT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0224_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0224 HUMAN PRESCRIPTION DRUG Goat Hair Goat Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CAPRA HIRCUS HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0225_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0225 HUMAN PRESCRIPTION DRUG Goose Feather Goose Feather INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ANSER ANSER FEATHER .05 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 49288-0226_13c9eea1-38b5-472b-b735-a814ca886718 49288-0226 HUMAN PRESCRIPTION DRUG Sweet Gum Sweet Gum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0227_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0227 HUMAN PRESCRIPTION DRUG Goldenrod Goldenrod INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0228_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0228 HUMAN PRESCRIPTION DRUG Geotrichum candidum Geotrichum candidum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GEOTRICHUM CANDIDUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0229_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0229 HUMAN PRESCRIPTION DRUG Guinea Pig Hair Guinea Pig Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CAVIA PORCELLUS HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] E 20171231 49288-0230_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0230 HUMAN PRESCRIPTION DRUG Guinea Pig Hair Guinea Pig Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CAVIA PORCELLUS HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] E 20171231 49288-0231_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0231 HUMAN PRESCRIPTION DRUG White Grape White Grape INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. WINE GRAPE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0232_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0232 HUMAN PRESCRIPTION DRUG Mixture of Four Standardized Grasses Mixture of Four Standardized Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN 25000; 25000; 25000; 25000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0233_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0233 HUMAN PRESCRIPTION DRUG Mixture of Five Standardized Grasses Mixture of Five Standardized Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN 20000; 20000; 20000; 20000; 20000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0234_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0234 HUMAN PRESCRIPTION DRUG Mixture of Six Standardized Grasses Mixture of Six Standardized Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN 16667; 16667; 16667; 16667; 16667; 16667 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0235_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0235 HUMAN PRESCRIPTION DRUG Mixture of Seven Standardized Grasses Mixture of Seven Standardized Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; ANTHOXANTHUM ODORATUM POLLEN 14286; 14286; 14286; 14286; 14286; 14286; 14286 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0236_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0236 HUMAN PRESCRIPTION DRUG Mixture of Eight Standardized Grasses Mixture of Eight Standardized Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102226 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; ANTHOXANTHUM ODORATUM POLLEN 1250; 12500; 12500; 12500; 12500; 12500; 12500; 12500 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0238_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0238 HUMAN PRESCRIPTION DRUG Number Fourteen Grass Mixture Number Fourteen Grass Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102223 Antigen Laboratories, Inc. POA COMPRESSA POLLEN; TYPHA LATIFOLIA POLLEN; BROMUS SECALINUS POLLEN; ZEA MAYS POLLEN; SECALE CEREALE POLLEN; TRITICUM AESTIVUM POLLEN; SORGHUM HALEPENSE POLLEN; ELYMUS REPENS POLLEN; PHALARIS ARUNDINACEA POLLEN; BROMUS INERMIS POLLEN; SORGHUM BICOLOR SSP. DRUMMONDII POLLEN; ARRHENATHERUM ELATIUS POLLEN; HOLCUS LANATUS POLLEN; PASCOPYRUM SMITHII POLLEN .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0239_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0239 HUMAN PRESCRIPTION DRUG Mixture of Standardized and Non-Standardized Southern Grasses Mixture of Standardized and Non-Standardized Southern Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102226 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; AGROSTIS GIGANTEA POLLEN; SORGHUM HALEPENSE POLLEN 1667; 16667; 16667; 16667; 16667; .0083 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0240_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0240 HUMAN PRESCRIPTION DRUG Mixture of Twenty-Two Standardized and Non-Standardized Grasses Mixture of Twenty-Two Standardized and Non-Standardized Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102226 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; POA COMPRESSA POLLEN; TYPHA LATIFOLIA POLLEN; BROMUS SECALINUS POLLEN; ZEA MAYS POLLEN; SECALE CEREALE POLLEN; TRITICUM AESTIVUM POLLEN; SORGHUM HALEPENSE POLLEN; ELYMUS REPENS POLLEN; PHALARIS ARUNDINACEA POLLEN; BROMUS INERMIS POLLEN; SORGHUM BICOLOR SSP. DRUMMONDII POLLEN; ARRHENATHERUM ELATIUS POLLEN; HOLCUS LANATUS POLLEN; PASCOPYRUM SMITHII POLLEN 455; 4545; 4545; 4545; 4545; 4545; 4545; 4545; .00227; .00227; .00227; .00227; .00227; .00227; .00227; .00227; .00227; .00227; .00227; .00227; .00227; .00227 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0241_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0241 HUMAN PRESCRIPTION DRUG Mixture of Standardized and Non-Standardized Inland Grasses Mixture of Standardized and Non-Standardized Inland Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; POA COMPRESSA POLLEN; BROMUS INERMIS POLLEN 14286; 14286; 14286; 14286; 14286; .0071; .0071 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0242_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0242 HUMAN PRESCRIPTION DRUG Mixture of Standardized and Non-Standardized Coastal Grasses Mixture of Standardized and Non-Standardized Coastal Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; PHLEUM PRATENSE POLLEN; POA COMPRESSA POLLEN; ARRHENATHERUM ELATIUS POLLEN; HOLCUS LANATUS POLLEN 11111; 11111; 11111; 11111; 11111; 11111; .0056; .0056; .0056 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0243_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0243 HUMAN PRESCRIPTION DRUG Mixture of Standardized and Non-Standardized Southeastern Grasses Mixture of Standardized and Non-Standardized Southeastern Grasses INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102226 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; PASPALUM NOTATUM POLLEN 3333; 33333; .0167 [BAU]/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0244_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0244 HUMAN PRESCRIPTION DRUG Hormodendrum Hormodendrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0245_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0245 HUMAN PRESCRIPTION DRUG Hormodendrum Hormodendrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0246_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0246 HUMAN PRESCRIPTION DRUG Hormodendrum Hormodendrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .025 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0247_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0247 HUMAN PRESCRIPTION DRUG Helminthosporium Helminthosporium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SATIVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0248_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0248 HUMAN PRESCRIPTION DRUG Helminthosporium Helminthosporium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SATIVUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0249_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0249 HUMAN PRESCRIPTION DRUG Helminthosporium Helminthosporium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SATIVUS .025 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0250_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0250 NON-STANDARDIZED ALLERGENIC Haddock Haddock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HADDOCK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0251_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0251 NON-STANDARDIZED ALLERGENIC Halibut Halibut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PACIFIC HALIBUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0252_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0252 NON-STANDARDIZED ALLERGENIC Halibut Halibut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PACIFIC HALIBUT .02 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0253_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0253 NON-STANDARDIZED ALLERGENIC Herring Herring INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HERRING .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0254_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0254 HUMAN PRESCRIPTION DRUG Hops Hops INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HOPS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 49288-0255_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0255 HUMAN PRESCRIPTION DRUG Horse Hair Horse Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. EQUUS CABALLUS HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0256_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0256 HUMAN PRESCRIPTION DRUG Horse Hair Horse Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EQUUS CABALLUS HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0257_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0257 HUMAN PRESCRIPTION DRUG Horse Hair Horse Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EQUUS CABALLUS HAIR .02 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0258_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0258 HUMAN PRESCRIPTION DRUG Hog Hair Hog Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. SUS SCROFA HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0259_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0259 HUMAN PRESCRIPTION DRUG Hog Hair Hog Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SUS SCROFA HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0260_13c9eea1-38b5-472b-b735-a814ca886718 49288-0260 HUMAN PRESCRIPTION DRUG Hackberry Hackberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0261_13c9eea1-38b5-472b-b735-a814ca886718 49288-0261 HUMAN PRESCRIPTION DRUG Hazelnut Pollen Hazelnut Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CORYLUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0262_13c9eea1-38b5-472b-b735-a814ca886718 49288-0262 HUMAN PRESCRIPTION DRUG Hickory Pollen Mixture Hickory Pollen Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA CORDIFORMIS POLLEN; CARYA GLABRA POLLEN; CARYA OVATA POLLEN; CARYA ALBA POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0263_13c9eea1-38b5-472b-b735-a814ca886718 49288-0263 HUMAN PRESCRIPTION DRUG Shagbark Hickory Shagbark Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0264_13c9eea1-38b5-472b-b735-a814ca886718 49288-0264 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CARYA ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0265_13c9eea1-38b5-472b-b735-a814ca886718 49288-0265 HUMAN PRESCRIPTION DRUG White Hickory White Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0266_13c9eea1-38b5-472b-b735-a814ca886718 49288-0266 HUMAN PRESCRIPTION DRUG Hickory/Pecan Mixture Hickory/Pecan Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19960712 BLA BLA102223 Antigen Laboratories, Inc. CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0267_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0267 HUMAN PRESCRIPTION DRUG Marsh Elder Mixture Marsh Elder Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. IVA XANTHIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0268_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0268 HUMAN PRESCRIPTION DRUG Marsh Elder Mixture Marsh Elder Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. IVA XANTHIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN .01; .01 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0269_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0269 HUMAN PRESCRIPTION DRUG Burweed Marsh Elder Burweed Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. IVA XANTHIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0270_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0270 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0271_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0271 HUMAN PRESCRIPTION DRUG Rough Marsh Elder Rough Marsh Elder INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0272_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0272 HUMAN PRESCRIPTION DRUG Jute Jute INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CORCORUS CAPSULARIS FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0273_13c9eea1-38b5-472b-b735-a814ca886718 49288-0273 HUMAN PRESCRIPTION DRUG Oneseed Juniper Oneseed Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0274_13c9eea1-38b5-472b-b735-a814ca886718 49288-0274 HUMAN PRESCRIPTION DRUG Utah Juniper Utah Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0275_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0275 HUMAN PRESCRIPTION DRUG Johnson Grass Pollen Johnson Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. SORGHUM HALEPENSE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0276_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0276 HUMAN PRESCRIPTION DRUG Johnson Grass Pollen Johnson Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0277_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0277 HUMAN PRESCRIPTION DRUG Standardized Kentucky (June) Bluegrass Standardized Kentucky (June) Bluegrass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103421 Antigen Laboratories, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0278_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0278 HUMAN PRESCRIPTION DRUG Johnson Grass Smut Johnson Grass Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. SPORISORIUM CRUENTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0279_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0279 HUMAN PRESCRIPTION DRUG Johnson Grass Smut Johnson Grass Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SPORISORIUM CRUENTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0280_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0280 HUMAN PRESCRIPTION DRUG Johnson Grass Smut Johnson Grass Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SPORISORIUM CRUENTUM .02 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0281_13c9eea1-38b5-472b-b735-a814ca886718 49288-0281 HUMAN PRESCRIPTION DRUG Western (Sierra) Juniper Western (Sierra) Juniper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0282_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0282 HUMAN PRESCRIPTION DRUG Kochia Kochia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. KOCHIA SCOPARIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0283_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0283 HUMAN PRESCRIPTION DRUG Kochia Kochia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. KOCHIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0284_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0284 HUMAN PRESCRIPTION DRUG Kochia Kochia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. KOCHIA SCOPARIA POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0285_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0285 HUMAN PRESCRIPTION DRUG Kapok Kapok INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CEIBA PENTANDRA FIBER .05 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0286_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0286 HUMAN PRESCRIPTION DRUG Lettuce Lettuce INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LETTUCE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0287_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0287 HUMAN PRESCRIPTION DRUG Lamb Lamb INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LAMB .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 49288-0288_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0288 HUMAN PRESCRIPTION DRUG Lemon Lemon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LEMON 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0289_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0289 HUMAN PRESCRIPTION DRUG Lime Lime INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LIME (CITRUS) 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0290_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0290 HUMAN PRESCRIPTION DRUG Lentil Lentil INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LENTIL .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0291_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0291 NON-STANDARDIZED ALLERGENIC Lobster Lobster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LOBSTER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 49288-0292_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0292 HUMAN PRESCRIPTION DRUG Malt Malt INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MALT EXTRACT, BARLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 49288-0293_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0293 HUMAN PRESCRIPTION DRUG Monilia Mixture Monilia Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANDIDA TROPICALIS; NEUROSPORA INTERMEDIA .025; .025 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0294_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0294 HUMAN PRESCRIPTION DRUG Mucor Mixture Mucor Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. MUCOR PLUMBEUS; MUCOR RACEMOSUS; RHIZOPUS STOLONIFER .0333; .0333; .0333 g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0295_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0295 HUMAN PRESCRIPTION DRUG Mucor Mixture Mucor Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MUCOR PLUMBEUS; MUCOR RACEMOSUS; RHIZOPUS STOLONIFER .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0296_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0296 HUMAN PRESCRIPTION DRUG Mycogone perniciosa Mycogone perniciosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. HYPOMYCES PERNICIOSUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0297_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0297 HUMAN PRESCRIPTION DRUG Mycogone perniciosa Mycogone perniciosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HYPOMYCES PERNICIOSUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0298_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0298 HUMAN PRESCRIPTION DRUG Microsporum audouinii Microsporum audouinii INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MICROSPORUM AUDOUINII .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0299_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0299 HUMAN PRESCRIPTION DRUG Microsporum canis Microsporum canis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MICROSPORUM CANIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0300_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0300 HUMAN PRESCRIPTION DRUG Honeydew Melon Honeydew Melon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HONEYDEW MELON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0301_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0301 HUMAN PRESCRIPTION DRUG Cow Milk Cow Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COW MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] E 20171231 49288-0302_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0302 HUMAN PRESCRIPTION DRUG Goat Milk Goat Milk INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GOAT MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] E 20171231 49288-0303_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0303 HUMAN PRESCRIPTION DRUG Millet Millet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MILLET SEED .05 g/mL E 20171231 49288-0304_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0304 HUMAN PRESCRIPTION DRUG Mint Mint INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SPEARMINT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 49288-0305_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0305 HUMAN PRESCRIPTION DRUG Mushroom Mushroom INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CULTIVATED MUSHROOM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 49288-0306_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0306 HUMAN PRESCRIPTION DRUG Mustard Seed Mustard Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MUSTARD SEED .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 49288-0307_13c9eea1-38b5-472b-b735-a814ca886718 49288-0307 HUMAN PRESCRIPTION DRUG Coastal Maple Coastal Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER MACROPHYLLUM POLLEN .05 g/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0308_13c9eea1-38b5-472b-b735-a814ca886718 49288-0308 HUMAN PRESCRIPTION DRUG Maple Pollen Mixture Maple Pollen Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0309_13c9eea1-38b5-472b-b735-a814ca886718 49288-0309 HUMAN PRESCRIPTION DRUG Maple Pollen Mixture Maple Pollen Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN .0067; .0067; .0067 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0310_13c9eea1-38b5-472b-b735-a814ca886718 49288-0310 HUMAN PRESCRIPTION DRUG Mesquite Mesquite INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0311_13c9eea1-38b5-472b-b735-a814ca886718 49288-0311 HUMAN PRESCRIPTION DRUG Mulberry Mixture Mulberry Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0312_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0312 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CANDIDA ALBICANS .1 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 49288-0313_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0313 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANDIDA ALBICANS .05 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 49288-0314_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0314 HUMAN PRESCRIPTION DRUG Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANDIDA ALBICANS .02 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 49288-0315_89b69938-05fc-4bd8-9c55-4fb46e9018c7 49288-0315 HUMAN PRESCRIPTION DRUG Mattress Dust Mattress Dust INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HOUSE DUST .05 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] E 20171231 49288-0316_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0316 HUMAN PRESCRIPTION DRUG Mustard Greens Mustard Greens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MUSTARD GREENS .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0317_13c9eea1-38b5-472b-b735-a814ca886718 49288-0317 HUMAN PRESCRIPTION DRUG Melaleuca Melaleuca INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0318_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0318 HUMAN PRESCRIPTION DRUG Mucor racemosus Mucor racemosus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. MUCOR RACEMOSUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0319_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0319 HUMAN PRESCRIPTION DRUG Mucor racemosus Mucor racemosus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MUCOR RACEMOSUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0320_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0320 HUMAN PRESCRIPTION DRUG Candida tropicalis Candida tropicalis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CANDIDA TROPICALIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0321_13c9eea1-38b5-472b-b735-a814ca886718 49288-0321 HUMAN PRESCRIPTION DRUG Hard (Sugar) Maple Hard (Sugar) Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0322_13c9eea1-38b5-472b-b735-a814ca886718 49288-0322 HUMAN PRESCRIPTION DRUG Red Maple Red Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER RUBRUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0323_13c9eea1-38b5-472b-b735-a814ca886718 49288-0323 HUMAN PRESCRIPTION DRUG Soft (Silver) Maple Soft (Silver) Maple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACER SACCHARINUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0324_13c9eea1-38b5-472b-b735-a814ca886718 49288-0324 HUMAN PRESCRIPTION DRUG Red Mulberry Red Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MORUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0325_13c9eea1-38b5-472b-b735-a814ca886718 49288-0325 HUMAN PRESCRIPTION DRUG White Mulberry White Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MORUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0326_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0326 HUMAN PRESCRIPTION DRUG Neurospora intermedia Neurospora intermedia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. NEUROSPORA INTERMEDIA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0327_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0327 HUMAN PRESCRIPTION DRUG Nigrospora Nigrospora INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. KHUSKIA ORYZAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0328_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0328 HUMAN PRESCRIPTION DRUG Nigrospora Nigrospora INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. KHUSKIA ORYZAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0329_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0329 HUMAN PRESCRIPTION DRUG Nutmeg Nutmeg INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. NUTMEG .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 49288-0330_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0330 HUMAN PRESCRIPTION DRUG Nettle Pollen Nettle Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. URTICA DIOICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0331_13c9eea1-38b5-472b-b735-a814ca886718 49288-0331 HUMAN PRESCRIPTION DRUG Oak Mixture Oak Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN .0063; .0063; .0063; .0063; .0063; .0063; .0063; .0063 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0332_13c9eea1-38b5-472b-b735-a814ca886718 49288-0332 HUMAN PRESCRIPTION DRUG Oak Mixture Oak Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS MUEHLENBERGII POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS PALUSTRIS POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN .0025; .0025; .0025; .0025; .0025; .0025; .0025; .0025 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0333_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0333 HUMAN PRESCRIPTION DRUG Orange Orange INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ORANGE 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0334_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0334 HUMAN PRESCRIPTION DRUG Whole Grain Oat Whole Grain Oat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. OAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 49288-0335_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0335 HUMAN PRESCRIPTION DRUG Onion Onion INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ONION .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0336_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0336 NON-STANDARDIZED ALLERGENIC Oyster Oyster INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. OYSTER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 49288-0337_13c9eea1-38b5-472b-b735-a814ca886718 49288-0337 HUMAN PRESCRIPTION DRUG California (Coastal) Live Oak California (Coastal) Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0339_13c9eea1-38b5-472b-b735-a814ca886718 49288-0339 HUMAN PRESCRIPTION DRUG Olive Pollen Olive Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0340_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0340 HUMAN PRESCRIPTION DRUG Tall Oat Grass Tall Oat Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARRHENATHERUM ELATIUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0341_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0341 HUMAN PRESCRIPTION DRUG Standardized Orchard Grass Pollen Standardized Orchard Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102228 Antigen Laboratories, Inc. DACTYLIS GLOMERATA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0342_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0342 HUMAN PRESCRIPTION DRUG Oat Smut Oat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO AVENAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0343_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0343 HUMAN PRESCRIPTION DRUG Orris Root Orris Root INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .1 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0344_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0344 HUMAN PRESCRIPTION DRUG Orris Root Orris Root INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .05 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0345_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0345 HUMAN PRESCRIPTION DRUG Olive Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GREEN OLIVE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0346_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0346 HUMAN PRESCRIPTION DRUG Cultivated Oat Pollen Cultivated Oat Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AVENA SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0347_13c9eea1-38b5-472b-b735-a814ca886718 49288-0347 HUMAN PRESCRIPTION DRUG Orange Pollen Orange Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CITRUS SINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0348_13c9eea1-38b5-472b-b735-a814ca886718 49288-0348 HUMAN PRESCRIPTION DRUG Live Oak Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0349_13c9eea1-38b5-472b-b735-a814ca886718 49288-0349 HUMAN PRESCRIPTION DRUG Live Oak Live Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0350_13c9eea1-38b5-472b-b735-a814ca886718 49288-0350 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS ALBA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0351_13c9eea1-38b5-472b-b735-a814ca886718 49288-0351 HUMAN PRESCRIPTION DRUG White Oak White Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0352_13c9eea1-38b5-472b-b735-a814ca886718 49288-0352 HUMAN PRESCRIPTION DRUG Bur Oak Bur Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS MACROCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0353_13c9eea1-38b5-472b-b735-a814ca886718 49288-0353 HUMAN PRESCRIPTION DRUG Pin Oak Pin Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS PALUSTRIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0354_13c9eea1-38b5-472b-b735-a814ca886718 49288-0354 HUMAN PRESCRIPTION DRUG Russian Olive Russian Olive INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0355_13c9eea1-38b5-472b-b735-a814ca886718 49288-0355 HUMAN PRESCRIPTION DRUG Garrys Oak Garrys Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS GARRYANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0356_13c9eea1-38b5-472b-b735-a814ca886718 49288-0356 HUMAN PRESCRIPTION DRUG Gambel Oak Gambel Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS GAMBELII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0357_13c9eea1-38b5-472b-b735-a814ca886718 49288-0357 HUMAN PRESCRIPTION DRUG Number Three Oak Mixture Number Three Oak Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19760712 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0358_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0358 HUMAN PRESCRIPTION DRUG Pigweed Mixture Pigweed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0359_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0359 HUMAN PRESCRIPTION DRUG Pigweed Mixture Pigweed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN .005; .005; .005; .005 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0360_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0360 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0361_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0361 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0362_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0362 HUMAN PRESCRIPTION DRUG English Plantain English Plantain INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0363_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0363 HUMAN PRESCRIPTION DRUG Penicillium Mixture Penicillium Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI .0167; .0167; .0167; .0167; .0167; .0167 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0364_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0364 HUMAN PRESCRIPTION DRUG Penicillium Mixture Penicillium Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI .0083; .0083; .0083; .0083; .0083; .0083 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0365_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0365 HUMAN PRESCRIPTION DRUG Phoma Phoma INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PHOMA DESTRUCTIVA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0366_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0366 HUMAN PRESCRIPTION DRUG Phoma Phoma INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PHOMA DESTRUCTIVA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0367_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0367 HUMAN PRESCRIPTION DRUG Pullularia Pullularia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0368_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0368 HUMAN PRESCRIPTION DRUG Pullularia Pullularia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0369_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0369 HUMAN PRESCRIPTION DRUG Pullularia Pullularia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .025 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0370_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0370 HUMAN PRESCRIPTION DRUG Paecilomyces Paecilomyces INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PAECILOMYCES VARIOTII .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0371_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0371 HUMAN PRESCRIPTION DRUG Paecilomyces Paecilomyces INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PAECILOMYCES VARIOTII .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0372_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0372 HUMAN PRESCRIPTION DRUG Papularia Papularia INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. APIOSPORA MONTAGNEI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0373_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0373 HUMAN PRESCRIPTION DRUG Phycomyces Phycomyces INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PHYCOMYCES BLAKESLEEANUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0374_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0374 HUMAN PRESCRIPTION DRUG Potato Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POTATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0375_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0375 HUMAN PRESCRIPTION DRUG Pork Pork INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PORK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 49288-0376_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0376 HUMAN PRESCRIPTION DRUG Paprika Paprika INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PAPRIKA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 49288-0377_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0377 HUMAN PRESCRIPTION DRUG Parsley Parsley INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PARSLEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0378_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0378 HUMAN PRESCRIPTION DRUG Peach Peach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PEACH 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0379_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0379 HUMAN PRESCRIPTION DRUG Peanut Peanut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PEANUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 49288-0380_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0380 HUMAN PRESCRIPTION DRUG Green Pea Green Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PEA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0381_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0381 HUMAN PRESCRIPTION DRUG Black-eyed Pea Black-eyed Pea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BLACK-EYED PEA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] E 20171231 49288-0382_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0382 HUMAN PRESCRIPTION DRUG Pear Pear INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PEAR .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0383_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0383 HUMAN PRESCRIPTION DRUG Pecan Nut Meat Pecan Nut Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PECAN .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 49288-0384_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0384 HUMAN PRESCRIPTION DRUG Black Pepper Black Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BLACK PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0385_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0385 HUMAN PRESCRIPTION DRUG Red Pepper Red Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RED BELL PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0386_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0386 HUMAN PRESCRIPTION DRUG Green Bell Pepper Green Bell Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GREEN BELL PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0387_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0387 NON-STANDARDIZED ALLERGENIC Perch Perch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PERCH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0388_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0388 HUMAN PRESCRIPTION DRUG Sweet Potato Sweet Potato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SWEET POTATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0389_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0389 HUMAN PRESCRIPTION DRUG Pumpkin Pumpkin INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PUMPKIN 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0390_1d474d27-4ce9-4bf6-b468-4a92281edc72 49288-0390 HUMAN PRESCRIPTION DRUG Parakeet Feather Parakeet Feather INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MELOPSITTACUS UNDULATUS FEATHER .02 g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0391_13c9eea1-38b5-472b-b735-a814ca886718 49288-0391 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0392_13c9eea1-38b5-472b-b735-a814ca886718 49288-0392 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0393_13c9eea1-38b5-472b-b735-a814ca886718 49288-0393 HUMAN PRESCRIPTION DRUG Pecan Pollen Pecan Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0396_13c9eea1-38b5-472b-b735-a814ca886718 49288-0396 HUMAN PRESCRIPTION DRUG Ponderosa Pine Ponderosa Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS PONDEROSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0397_13c9eea1-38b5-472b-b735-a814ca886718 49288-0397 HUMAN PRESCRIPTION DRUG Poplar Mixture Poplar Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0398_13c9eea1-38b5-472b-b735-a814ca886718 49288-0398 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0399_13c9eea1-38b5-472b-b735-a814ca886718 49288-0399 HUMAN PRESCRIPTION DRUG Privet Privet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LIGUSTRUM VULGARE POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0400_13c9eea1-38b5-472b-b735-a814ca886718 49288-0400 HUMAN PRESCRIPTION DRUG Pepper Tree Pepper Tree INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0401_13c9eea1-38b5-472b-b735-a814ca886718 49288-0401 HUMAN PRESCRIPTION DRUG Queen Palm Queen Palm INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0402_13c9eea1-38b5-472b-b735-a814ca886718 49288-0402 HUMAN PRESCRIPTION DRUG Number Three Pine Mixture Number Three Pine Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS TAEDA POLLEN; PINUS PONDEROSA POLLEN; PINUS ECHINATA POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0403_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0403 HUMAN PRESCRIPTION DRUG Pyrethrum Pyrethrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PYRETHRUM CINERARIIFOLIUM .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0404_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0404 HUMAN PRESCRIPTION DRUG Pimento Pimento INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RED BELL PEPPER .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0405_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0405 HUMAN PRESCRIPTION DRUG Pineapple Pineapple INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINEAPPLE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0406_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0406 HUMAN PRESCRIPTION DRUG Plum Plum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLUM 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0407_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0407 HUMAN PRESCRIPTION DRUG Plum Plum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLUM .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0408_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0408 HUMAN PRESCRIPTION DRUG Rough (Redroot) Pigweed Rough (Redroot) Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0409_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0409 HUMAN PRESCRIPTION DRUG Rough (Redroot) Pigweed Rough (Redroot) Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0410_13c9eea1-38b5-472b-b735-a814ca886718 49288-0410 HUMAN PRESCRIPTION DRUG Eastern White Pine Eastern White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PINUS STROBUS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0411_13c9eea1-38b5-472b-b735-a814ca886718 49288-0411 HUMAN PRESCRIPTION DRUG Eastern White Pine Eastern White Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19790909 BLA BLA102223 Antigen Laboratories, Inc. PINUS STROBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0412_13c9eea1-38b5-472b-b735-a814ca886718 49288-0412 HUMAN PRESCRIPTION DRUG Australian Pine Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0413_13c9eea1-38b5-472b-b735-a814ca886718 49288-0413 HUMAN PRESCRIPTION DRUG Australian Pine Australian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0414_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0414 HUMAN PRESCRIPTION DRUG Spiny Pigweed Spiny Pigweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0415_13c9eea1-38b5-472b-b735-a814ca886718 49288-0415 HUMAN PRESCRIPTION DRUG Slash Pine Slash Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS ELLIOTTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0416_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0416 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0417_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0417 HUMAN PRESCRIPTION DRUG Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0418_13c9eea1-38b5-472b-b735-a814ca886718 49288-0418 HUMAN PRESCRIPTION DRUG White Poplar White Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0419_13c9eea1-38b5-472b-b735-a814ca886718 49288-0419 HUMAN PRESCRIPTION DRUG Lombardy Poplar Lombardy Poplar INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. POPULUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0420_13c9eea1-38b5-472b-b735-a814ca886718 49288-0420 HUMAN PRESCRIPTION DRUG Lodgepole Pine Lodgepole Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS CONTORTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0421_13c9eea1-38b5-472b-b735-a814ca886718 49288-0421 HUMAN PRESCRIPTION DRUG Scotch Pine Scotch Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS SYLVESTRIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0422_13c9eea1-38b5-472b-b735-a814ca886718 49288-0422 HUMAN PRESCRIPTION DRUG Loblolly Pine Loblolly Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS TAEDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0423_13c9eea1-38b5-472b-b735-a814ca886718 49288-0423 HUMAN PRESCRIPTION DRUG Pitch Pine Pitch Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS RIGIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0424_13c9eea1-38b5-472b-b735-a814ca886718 49288-0424 HUMAN PRESCRIPTION DRUG Shortleaf Pine Shortleaf Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS ECHINATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0425_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0425 HUMAN PRESCRIPTION DRUG Poverty Weed Poverty Weed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. IVA AXILLARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0426_80e3a713-b3c2-4981-9f01-d987196bc528 49288-0426 HUMAN PRESCRIPTION DRUG Cayenne Pepper Cayenne Pepper INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHILI PEPPER .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0427_13c9eea1-38b5-472b-b735-a814ca886718 49288-0427 HUMAN PRESCRIPTION DRUG Number Two Pine Mixture Number Two Pine Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102223 Antigen Laboratories, Inc. PINUS CONTORTA POLLEN; PINUS PONDEROSA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0429_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0429 HUMAN PRESCRIPTION DRUG Bakers Yeast Bakers Yeast INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 49288-0430_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0430 HUMAN PRESCRIPTION DRUG Quack Grass Quack Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0431_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0431 HUMAN PRESCRIPTION DRUG Ragweed Mixture Ragweed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0432_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0432 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. SALSOLA KALI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0433_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0433 HUMAN PRESCRIPTION DRUG Russian Thistle Russian Thistle INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0434_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0434 HUMAN PRESCRIPTION DRUG Rhizopus Rhizopus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. RHIZOPUS STOLONIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0435_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0435 HUMAN PRESCRIPTION DRUG Rhizopus Rhizopus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RHIZOPUS STOLONIFER .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0436_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0436 HUMAN PRESCRIPTION DRUG Rhodotorula Rhodotorula INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RHODOTORULA RUBRA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0437_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0437 HUMAN PRESCRIPTION DRUG Rabbit Meat Rabbit Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RABBIT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 49288-0438_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0438 HUMAN PRESCRIPTION DRUG Radish Radish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RAPHANUS SATIVUS .05 g/mL E 20171231 49288-0439_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0439 HUMAN PRESCRIPTION DRUG Raspberry Raspberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RASPBERRY 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0440_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0440 HUMAN PRESCRIPTION DRUG Raspberry Raspberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RASPBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0441_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0441 HUMAN PRESCRIPTION DRUG Rice Rice INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RICE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 49288-0442_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0442 HUMAN PRESCRIPTION DRUG Rye Rye INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RYE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 49288-0443_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0443 HUMAN PRESCRIPTION DRUG Rabbit Hair Rabbit Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ORYCTOLAGUS CUNICULUS HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] E 20171231 49288-0444_f08d6882-f5d5-4109-b9df-64c85e82a0a1 49288-0444 HUMAN PRESCRIPTION DRUG Rabbit Hair Rabbit Hair INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ORYCTOLAGUS CUNICULUS HAIR .05 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] E 20171231 49288-0445_bffa4c39-d658-4a1c-b00a-3f0c411fa524 49288-0445 HUMAN PRESCRIPTION DRUG Redwood Pollen Redwood Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SEQUOIA SEMPERVIRENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0446_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0446 HUMAN PRESCRIPTION DRUG Slender Ragweed Slender Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA CONFERTIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0447_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0447 HUMAN PRESCRIPTION DRUG Giant Ragweed Giant Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0448_3a632396-c97c-4b7f-8eef-8908cf591385 49288-0448 HUMAN PRESCRIPTION DRUG Standardized Short Ragweed Pollen Standardized Short Ragweed Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19830115 BLA BLA102232 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 100000 [AU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0449_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0449 HUMAN PRESCRIPTION DRUG Southern Ragweed Southern Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA BIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0450_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0450 HUMAN PRESCRIPTION DRUG Western Ragweed Western Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0451_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0451 HUMAN PRESCRIPTION DRUG Standardized Redtop Grass Pollen Standardized Redtop Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102229 Antigen Laboratories, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0452_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0452 HUMAN PRESCRIPTION DRUG Standardized Perennial Rye Grass Pollen Standardized Perennial Rye Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102230 Antigen Laboratories, Inc. LOLIUM PERENNE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0453_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0453 HUMAN PRESCRIPTION DRUG Cultivated Rye Grass Cultivated Rye Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SECALE CEREALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0454_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0454 HUMAN PRESCRIPTION DRUG Short/Giant Ragweed Mixture Short/Giant Ragweed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0455_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0455 HUMAN PRESCRIPTION DRUG Desert Ragweed Desert Ragweed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA DUMOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0456_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0456 HUMAN PRESCRIPTION DRUG Short/Giant/Western Ragweed Mixture Short/Giant/Western Ragweed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0457_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0457 HUMAN PRESCRIPTION DRUG Sage Mixture Sage Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA VULGARIS POLLEN; ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA LUDOVICIANA POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0458_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0458 HUMAN PRESCRIPTION DRUG Sage Mixture Sage Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA VULGARIS POLLEN; ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA LUDOVICIANA POLLEN .005; .005; .005; .005 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0459_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0459 HUMAN PRESCRIPTION DRUG Sorrel Mixture Sorrel Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX OBTUSIFOLIUS POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX ALTISSIMUS POLLEN; RUMEX SALICIFOLIUS VAR. MEXICANUS POLLEN; RUMEX CRISPUS POLLEN .01; .01; .01; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0460_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0460 HUMAN PRESCRIPTION DRUG Sorrel Mixture Sorrel Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX OBTUSIFOLIUS POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX ALTISSIMUS POLLEN; RUMEX SALICIFOLIUS VAR. MEXICANUS POLLEN; RUMEX CRISPUS POLLEN .004; .004; .004; .004; .004 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0461_f1a31511-6642-4da5-82cf-67c9ca728bc6 49288-0461 HUMAN PRESCRIPTION DRUG Miller Moth Miller Moth INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SITOTROGA CEREALELLA .05 g/mL E 20171231 49288-0462_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0462 HUMAN PRESCRIPTION DRUG Saccharomyces Saccharomyces INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 49288-0463_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0463 HUMAN PRESCRIPTION DRUG Scopulariopsis Scopulariopsis INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MICROASCUS BREVICAULIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0464_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0464 HUMAN PRESCRIPTION DRUG Spondylocladium Spondylocladium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. COLLETOTRICHUM COCCODES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0465_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0465 HUMAN PRESCRIPTION DRUG Spondylocladium Spondylocladium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. COLLETOTRICHUM COCCODES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0466_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0466 HUMAN PRESCRIPTION DRUG Stemphylium Stemphylium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PLEOSPORA HERBARUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0467_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0467 HUMAN PRESCRIPTION DRUG Stemphylium Stemphylium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLEOSPORA HERBARUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0468_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0468 HUMAN PRESCRIPTION DRUG Streptomyces Streptomyces INJECTION, SOLUTION INTRADERMAL; SUBCONJUNCTIVAL 19740323 BLA BLA102223 Antigen Laboratories, Inc. STREPTOMYCES GRISEUS .05 g/mL Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0469_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0469 HUMAN PRESCRIPTION DRUG Sporotrichum Sporotrichum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SPOROTRICHUM PRUINOSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0470_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0470 HUMAN PRESCRIPTION DRUG Stachybotrys Stachybotrys INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. STACHYBOTRYS CHARTARUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0471_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0471 HUMAN PRESCRIPTION DRUG Stachybotrys Stachybotrys INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. STACHYBOTRYS CHARTARUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0472_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0472 HUMAN PRESCRIPTION DRUG Syncephalastrum Syncephalastrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SYNCEPHALASTRUM RACEMOSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0473_38eb8027-2cc3-42f8-ad39-70588a8bd791 49288-0473 HUMAN PRESCRIPTION DRUG Sole Sole INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ENGLISH SOLE .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0474_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0474 HUMAN PRESCRIPTION DRUG Safflower Seed Safflower Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SAFFLOWER .05 g/mL E 20171231 49288-0475_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0475 HUMAN PRESCRIPTION DRUG Sesame Seed Sesame Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SESAME SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0476_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0476 NON-STANDARDIZED ALLERGENIC Salmon Salmon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATLANTIC SALMON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0477_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0477 NON-STANDARDIZED ALLERGENIC Sardine Sardine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. EUROPEAN PILCHARD .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0478_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0478 NON-STANDARDIZED ALLERGENIC Shrimp Shrimp INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SHRIMP .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] E 20171231 49288-0479_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0479 HUMAN PRESCRIPTION DRUG Spinach Spinach INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SPINACH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0480_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0480 HUMAN PRESCRIPTION DRUG Strawberry Strawberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. STRAWBERRY 1 mL/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0481_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0481 HUMAN PRESCRIPTION DRUG Sugar Beet Sugar Beet INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BEET .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0482_80e3a713-b3c2-4981-9f01-d987196bc528 49288-0482 HUMAN PRESCRIPTION DRUG Sugar Cane Sugar Cane INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SUGARCANE .05 g/mL E 20171231 49288-0483_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0483 HUMAN PRESCRIPTION DRUG Sunflower Seed Sunflower Seed INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SUNFLOWER SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0484_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0484 HUMAN PRESCRIPTION DRUG Annual Saltbush Annual Saltbush INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0485_13c9eea1-38b5-472b-b735-a814ca886718 49288-0485 HUMAN PRESCRIPTION DRUG American Sycamore American Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0486_13c9eea1-38b5-472b-b735-a814ca886718 49288-0486 HUMAN PRESCRIPTION DRUG American Sycamore American Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0487_13c9eea1-38b5-472b-b735-a814ca886718 49288-0487 HUMAN PRESCRIPTION DRUG California Sycamore California Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLATANUS RACEMOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0488_13c9eea1-38b5-472b-b735-a814ca886718 49288-0488 HUMAN PRESCRIPTION DRUG Maple Leaf Sycamore Maple Leaf Sycamore INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PLATANUS HYBRIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0489_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0489 HUMAN PRESCRIPTION DRUG Coastal Sage Coastal Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0490_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0490 HUMAN PRESCRIPTION DRUG Sunflower Pollen Sunflower Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HELIANTHUS ANNUUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0491_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0491 HUMAN PRESCRIPTION DRUG Sudan Grass Sudan Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SORGHUM BICOLOR SSP. DRUMMONDII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0492_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0492 HUMAN PRESCRIPTION DRUG Standardized Sweet Vernal Grass Pollen Standardized Sweet Vernal Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA103624 Antigen Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0493_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0493 HUMAN PRESCRIPTION DRUG Sage Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SALVIA OFFICINALIS .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0494_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0494 HUMAN PRESCRIPTION DRUG Saltgrass Saltgrass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0495_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0495 HUMAN PRESCRIPTION DRUG Common Mugwort Sage Common Mugwort Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0496_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0496 HUMAN PRESCRIPTION DRUG Desert Sage Desert Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0497_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0497 HUMAN PRESCRIPTION DRUG Desert Sage Desert Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0498_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0498 HUMAN PRESCRIPTION DRUG Common Wormwood Sage Common Wormwood Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0499_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0499 HUMAN PRESCRIPTION DRUG Western Mugwort Sage Western Mugwort Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0560_13c9eea1-38b5-472b-b735-a814ca886718 49288-0560 HUMAN PRESCRIPTION DRUG Tree Mixture Tree Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; CARPINUS CAROLINIANA POLLEN; PICEA PUNGENS POLLEN; ACER NEGUNDO POLLEN; PINUS STROBUS POLLEN; CELTIS OCCIDENTALIS POLLEN; ACER SACCHARUM POLLEN; JUNIPERUS ASHEI POLLEN; BETULA PAPYRIFERA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER RUBRUM POLLEN; MORUS RUBRA POLLEN; JUNIPERUS PINCHOTII POLLEN; CARYA OVATA POLLEN; ACER SACCHARINUM POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; AILANTHUS ALTISSIMA POLLEN; FRAXINUS AMERICANA POLLEN; CARYA ALBA POLLEN; MORUS ALBA POLLEN; POPULUS ALBA POLLEN .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021; .0021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] E 20171231 49288-0561_13c9eea1-38b5-472b-b735-a814ca886718 49288-0561 HUMAN PRESCRIPTION DRUG Tree Mixture Tree Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; CARPINUS CAROLINIANA POLLEN; PICEA PUNGENS POLLEN; ACER NEGUNDO POLLEN; PINUS STROBUS POLLEN; CELTIS OCCIDENTALIS POLLEN; ACER SACCHARUM POLLEN; JUNIPERUS ASHEI POLLEN; BETULA PAPYRIFERA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER RUBRUM POLLEN; MORUS RUBRA POLLEN; JUNIPERUS PINCHOTII POLLEN; CARYA OVATA POLLEN; ACER SACCHARINUM POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; AILANTHUS ALTISSIMA POLLEN; FRAXINUS AMERICANA POLLEN; CARYA ALBA POLLEN; MORUS ALBA POLLEN; POPULUS ALBA POLLEN .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008; .0008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] E 20171231 49288-0562_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0562 HUMAN PRESCRIPTION DRUG Trichoderma Trichoderma INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. TRICHODERMA VIRIDE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0563_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0563 HUMAN PRESCRIPTION DRUG Trichoderma Trichoderma INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHODERMA VIRIDE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0564_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0564 HUMAN PRESCRIPTION DRUG Tetracoccosporium paxianum Tetracoccosporium paxianum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TETRACOCCOSPORIUM PAXIANUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0565_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0565 HUMAN PRESCRIPTION DRUG Tomato Tomato INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TOMATO .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 49288-0566_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0566 HUMAN PRESCRIPTION DRUG Tapioca Tapioca INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. STARCH, TAPIOCA .05 g/mL E 20171231 49288-0567_80e3a713-b3c2-4981-9f01-d987196bc528 49288-0567 HUMAN PRESCRIPTION DRUG Tea Tea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TEA LEAF .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0568_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0568 NON-STANDARDIZED ALLERGENIC Trout Trout INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TROUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0569_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0569 NON-STANDARDIZED ALLERGENIC Tuna Tuna INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TUNA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0570_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0570 HUMAN PRESCRIPTION DRUG Turkey Turkey INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TURKEY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] E 20171231 49288-0571_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0571 HUMAN PRESCRIPTION DRUG Turnip Turnip INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TURNIP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0572_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0572 HUMAN PRESCRIPTION DRUG Thyme Thyme INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GARDEN THYME .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0573_13c9eea1-38b5-472b-b735-a814ca886718 49288-0573 HUMAN PRESCRIPTION DRUG Tamarack Tamarack INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. LARIX OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0574_13c9eea1-38b5-472b-b735-a814ca886718 49288-0574 HUMAN PRESCRIPTION DRUG Tree of Heaven Tree of Heaven INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0575_bb0c98b2-aaa8-49c4-887a-928e3937769c 49288-0575 HUMAN PRESCRIPTION DRUG Standardized Timothy Grass Pollen Standardized Timothy Grass Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970613 BLA BLA102231 Antigen Laboratories, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0576_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0576 HUMAN PRESCRIPTION DRUG Trichophyton Mixture Trichophyton Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTON RUBRUM .05; .05 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0577_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0577 HUMAN PRESCRIPTION DRUG Trichophyton Mixture Trichophyton Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTON RUBRUM .025; .025 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0578_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0578 HUMAN PRESCRIPTION DRUG Trichophyton Mixture Trichophyton Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTON RUBRUM .01; .01 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0579_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0579 HUMAN PRESCRIPTION DRUG Trichophyton rubrum Trichophyton rubrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON RUBRUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0580_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0580 HUMAN PRESCRIPTION DRUG Trichophyton rubrum Trichophyton rubrum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON RUBRUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0581_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0581 HUMAN PRESCRIPTION DRUG Leaf Tobacco Leaf Tobacco INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. TOBACCO LEAF .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0582_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0582 HUMAN PRESCRIPTION DRUG Leaf Tobacco Leaf Tobacco INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TOBACCO LEAF .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0583_3af4be6b-c022-4834-9006-f6cc8d8041da 49288-0583 HUMAN PRESCRIPTION DRUG Leaf Tobacco Leaf Tobacco INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TOBACCO LEAF .02 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 49288-0584_13c9eea1-38b5-472b-b735-a814ca886718 49288-0584 HUMAN PRESCRIPTION DRUG Number Eleven Tree Mixture Number Eleven Tree Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN; ULMUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ACER SACCHARUM POLLEN; QUERCUS RUBRA POLLEN; BETULA NIGRA POLLEN; CARYA OVATA POLLEN; FRAXINUS AMERICANA POLLEN .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0585_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0585 HUMAN PRESCRIPTION DRUG Trichophyton mentagrophytes Trichophyton mentagrophytes INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0586_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0586 HUMAN PRESCRIPTION DRUG Number Ten Mold Mixture Number Ten Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19920413 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER .01; .0025; .0025; .0025; .0025; .01; .01; .01; .01; .0017; .0017; .0017; .0017; .0017; .0017; .01; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0587_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0587 HUMAN PRESCRIPTION DRUG Number Ten Mold Mixture Number Ten Mold Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER .005; .0013; .0013; .0013; .0013; .005; .005; .005; .005; .0008; .0008; .0008; .0008; .0008; .0008; .005; .005; .005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0588_13c9eea1-38b5-472b-b735-a814ca886718 49288-0588 HUMAN PRESCRIPTION DRUG Washington/Oregon Coastal Tree Mixture Washington/Oregon Coastal Tree Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19960712 BLA BLA102223 Antigen Laboratories, Inc. POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; JUGLANS NIGRA POLLEN; PINUS CONTORTA POLLEN; JUGLANS REGIA POLLEN; QUERCUS GARRYANA POLLEN; FRAXINUS LATIFOLIA POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0589_13c9eea1-38b5-472b-b735-a814ca886718 49288-0589 HUMAN PRESCRIPTION DRUG Washington/Oregon Inland Tree Mixture Washington/Oregon Inland Tree Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19960712 BLA BLA102223 Antigen Laboratories, Inc. POPULUS TREMULOIDES POLLEN; POPULUS BALSAMIFERA SUBSP. TRICHOCARPA POLLEN; ACER NEGUNDO POLLEN; PINUS CONTORTA POLLEN; FRAXINUS LATIFOLIA POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; PINUS PONDEROSA POLLEN; SALIX LUCIDA SSP. LASIANDRA POLLEN .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056; .0056 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0590_13c9eea1-38b5-472b-b735-a814ca886718 49288-0590 HUMAN PRESCRIPTION DRUG Number Seven Tree Mixture Number Seven Tree Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102223 Antigen Laboratories, Inc. ULMUS AMERICANA POLLEN; QUERCUS VIRGINIANA POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; CARYA ILLINOINENSIS POLLEN; BETULA NIGRA POLLEN; JUNIPERUS VIRGINIANA; POPULUS ALBA POLLEN .0071; .0071; .0024; .0024; .0024; .0071; .0071; .0071; .0071 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0591_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0591 HUMAN PRESCRIPTION DRUG Vanilla Bean Vanilla Bean INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. VANILLA .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0592_ab729e90-03ec-4b3a-8c11-390b49ff5173 49288-0592 HUMAN PRESCRIPTION DRUG Venison Venison INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. VENISON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] E 20171231 49288-0593_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0593 HUMAN PRESCRIPTION DRUG Velvet Grass Velvet Grass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HOLCUS LANATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0594_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0594 HUMAN PRESCRIPTION DRUG Verticillium Verticillium INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. VERTICILLIUM ALBO-ATRUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0595_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0595 HUMAN PRESCRIPTION DRUG Whole Wheat Whole Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. WHEAT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] E 20171231 49288-0596_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0596 HUMAN PRESCRIPTION DRUG English Walnut Meat English Walnut Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ENGLISH WALNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 49288-0597_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0597 HUMAN PRESCRIPTION DRUG Black Walnut Meat Black Walnut Meat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BLACK WALNUT .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] E 20171231 49288-0598_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0598 HUMAN PRESCRIPTION DRUG Watermelon Watermelon INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. WATERMELON .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] E 20171231 49288-0599_28463a0e-70af-4169-b592-df65f4f13a5f 49288-0599 NON-STANDARDIZED ALLERGENIC White Fish White Fish INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. WHITEFISH .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] E 20171231 49288-0600_13c9eea1-38b5-472b-b735-a814ca886718 49288-0600 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUGLANS NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0601_13c9eea1-38b5-472b-b735-a814ca886718 49288-0601 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0602_13c9eea1-38b5-472b-b735-a814ca886718 49288-0602 HUMAN PRESCRIPTION DRUG Black Walnut Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUGLANS NIGRA POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0603_13c9eea1-38b5-472b-b735-a814ca886718 49288-0603 HUMAN PRESCRIPTION DRUG California Black Walnut California Black Walnut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUGLANS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0605_13c9eea1-38b5-472b-b735-a814ca886718 49288-0605 HUMAN PRESCRIPTION DRUG English Walnut Pollen English Walnut Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. JUGLANS REGIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0606_13c9eea1-38b5-472b-b735-a814ca886718 49288-0606 HUMAN PRESCRIPTION DRUG Western Black Willow Western Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SALIX LUCIDA SSP. LASIANDRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0607_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0607 HUMAN PRESCRIPTION DRUG Wheat Smut Wheat Smut INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19970909 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO TRITICI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0608_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0608 HUMAN PRESCRIPTION DRUG Cultivated Wheat Cultivated Wheat INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRITICUM AESTIVUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0609_13c9eea1-38b5-472b-b735-a814ca886718 49288-0609 HUMAN PRESCRIPTION DRUG Pussy Willow Pussy Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19770909 BLA BLA102223 Antigen Laboratories, Inc. SALIX DISCOLOR POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0610_13c9eea1-38b5-472b-b735-a814ca886718 49288-0610 HUMAN PRESCRIPTION DRUG Black Willow Black Willow INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0611_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0611 HUMAN PRESCRIPTION DRUG Number Two Weed Mixture Number Two Weed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN .01; .01; .01; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0612_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0612 HUMAN PRESCRIPTION DRUG Number Four Weed Mixture Number Four Weed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA CALIFORNICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ARTEMISIA VULGARIS POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA DRACUNCULUS POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA AXILLARIS POLLEN; ARTEMISIA FRIGIDA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS TUBERCULATUS POLLEN; RUMEX CRISPUS POLLEN .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036; .0036 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0613_0247493a-8221-44f5-afa6-071bde3bfac2 49288-0613 HUMAN PRESCRIPTION DRUG Western Wheatgrass Western Wheatgrass INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PASCOPYRUM SMITHII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0614_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0614 HUMAN PRESCRIPTION DRUG Washington/Oregon Coastal Weed Mixture Washington/Oregon Coastal Weed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19960711 BLA BLA102223 Antigen Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN; ARTEMISIA VULGARIS POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN .0071; .0071; .0071; .0071; .0071; .0071; .0071 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0615_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0615 HUMAN PRESCRIPTION DRUG Washington/Oregon Inland Weed Mixture Washington/Oregon Inland Weed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19960711 BLA BLA102223 Antigen Laboratories, Inc. IVA XANTHIFOLIA POLLEN; ARTEMISIA VULGARIS POLLEN; ARTEMISIA TRIDENTATA POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA TRIFIDA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ATRIPLEX CANESCENS POLLEN .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045; .0045 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0616_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0616 HUMAN PRESCRIPTION DRUG Number Three Weed Mixture Number Three Weed Mixture INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19960711 BLA BLA102223 Antigen Laboratories, Inc. KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN .0125; .0125; .0125; .0125 g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0617_1d11d7ba-8b48-401c-a02e-42b54abb4296 49288-0617 HUMAN PRESCRIPTION DRUG Brewers Yeast Brewers Yeast INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. SACCHAROMYCES CEREVISIAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] E 20171231 49288-0618_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0618 HUMAN PRESCRIPTION DRUG Trichophyton schoenleinii Trichophyton schoenleinii INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. TRICHOPHYTON SCHOENLEINII .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0619_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0619 HUMAN PRESCRIPTION DRUG Absidia ramosa Absidia ramosa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MYCOCLADUS CORYMBIFERUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0620_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0620 HUMAN PRESCRIPTION DRUG Acrothecium robustum Acrothecium robustum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ACROTHECIUM ROBUSTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0621_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0621 HUMAN PRESCRIPTION DRUG Aspergillus repens Aspergillus repens INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS REPENS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0622_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0622 HUMAN PRESCRIPTION DRUG Allscale Allscale INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ATRIPLEX POLYCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0623_13c9eea1-38b5-472b-b735-a814ca886718 49288-0623 HUMAN PRESCRIPTION DRUG Green Ash Green Ash INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS PENNSYLVANICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0624_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0624 HUMAN PRESCRIPTION DRUG Aspergillus flavus Aspergillus flavus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FLAVUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0625_13c9eea1-38b5-472b-b735-a814ca886718 49288-0625 HUMAN PRESCRIPTION DRUG Blue Beech (Hornbeam) Blue Beech (Hornbeam) INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARPINUS CAROLINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0626_13c9eea1-38b5-472b-b735-a814ca886718 49288-0626 HUMAN PRESCRIPTION DRUG Black Birch Black Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0627_13c9eea1-38b5-472b-b735-a814ca886718 49288-0627 HUMAN PRESCRIPTION DRUG Yellow Birch Yellow Birch INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BETULA ALLEGHANIENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0628_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0628 HUMAN PRESCRIPTION DRUG Jerusalem Oak Jerusalem Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM BOTRYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0629_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0629 HUMAN PRESCRIPTION DRUG Tall Dock Tall Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX ALTISSIMUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0630_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0630 HUMAN PRESCRIPTION DRUG Bitter Dock Bitter Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX OBTUSIFOLIUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0631_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0631 HUMAN PRESCRIPTION DRUG White (Mexican) Dock White (Mexican) Dock INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RUMEX SALICIFOLIUS VAR. MEXICANUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0633_13c9eea1-38b5-472b-b735-a814ca886718 49288-0633 HUMAN PRESCRIPTION DRUG Pignut Hickory Pignut Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA GLABRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0634_13c9eea1-38b5-472b-b735-a814ca886718 49288-0634 HUMAN PRESCRIPTION DRUG Bitternut Hickory Bitternut Hickory INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. CARYA CORDIFORMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0635_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0635 HUMAN PRESCRIPTION DRUG Humicola grisea Humicola grisea INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. HUMICOLA GRISEA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0636_13c9eea1-38b5-472b-b735-a814ca886718 49288-0636 HUMAN PRESCRIPTION DRUG Paper Mulberry Paper Mulberry INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0637_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0637 HUMAN PRESCRIPTION DRUG Mucor mucedo Mucor mucedo INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. RHIZOPUS STOLONIFER .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0638_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0638 HUMAN PRESCRIPTION DRUG Mucor plumbeus Mucor plumbeus INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. MUCOR PLUMBEUS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0639_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0639 HUMAN PRESCRIPTION DRUG Neurospora crassa Neurospora crassa INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. NEUROSPORA CRASSA .05 g/mL E 20171231 49288-0640_13c9eea1-38b5-472b-b735-a814ca886718 49288-0640 HUMAN PRESCRIPTION DRUG Black Oak Black Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0641_13c9eea1-38b5-472b-b735-a814ca886718 49288-0641 HUMAN PRESCRIPTION DRUG Chestnut Oak Chestnut Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS MUEHLENBERGII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0642_13c9eea1-38b5-472b-b735-a814ca886718 49288-0642 HUMAN PRESCRIPTION DRUG Post Oak Post Oak INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS STELLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0643_bffa4c39-d658-4a1c-b00a-3f0c411fa524 49288-0643 HUMAN PRESCRIPTION DRUG Jack Pine Pollen Jack Pine Pollen INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS BANKSIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0644_13c9eea1-38b5-472b-b735-a814ca886718 49288-0644 HUMAN PRESCRIPTION DRUG Red Pine Red Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS RESINOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0645_13c9eea1-38b5-472b-b735-a814ca886718 49288-0645 HUMAN PRESCRIPTION DRUG Austrian Pine Austrian Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0646_13c9eea1-38b5-472b-b735-a814ca886718 49288-0646 HUMAN PRESCRIPTION DRUG Japanese Black Pine Japanese Black Pine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PINUS THUNBERGII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0647_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0647 HUMAN PRESCRIPTION DRUG Penicillium roquefortii Penicillium roquefortii INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM ROQUEFORTI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0648_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0648 HUMAN PRESCRIPTION DRUG Penicillium camembertii Penicillium camembertii INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CAMEMBERTI .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0649_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0649 HUMAN PRESCRIPTION DRUG Penicillium chrysogenum Penicillium chrysogenum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0650_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0650 HUMAN PRESCRIPTION DRUG Penicillium expansum Penicillium expansum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM EXPANSUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0651_272c9910-2160-4d41-afbd-faab3055ba1d 49288-0651 HUMAN PRESCRIPTION DRUG Penicillium italicum Penicillium italicum INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM ITALICUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0652_13c9eea1-38b5-472b-b735-a814ca886718 49288-0652 HUMAN PRESCRIPTION DRUG Blue Spruce Blue Spruce INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PICEA PUNGENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0653_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0653 HUMAN PRESCRIPTION DRUG Prairie Sage Prairie Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA FRIGIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0654_8b59a012-60d1-4fa4-9ee7-fe89524760a2 49288-0654 HUMAN PRESCRIPTION DRUG Indian Wormwood Sage Indian Wormwood Sage INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ARTEMISIA DRACUNCULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0655_fb54abb5-85cd-485f-9542-a2742a31bf72 49288-0655 HUMAN PRESCRIPTION DRUG Coca-Glycerine Control Coca-Glycerine Control INJECTION, SOLUTION INTRADERMAL 19740323 BLA BLA102223 Antigen Laboratories, Inc. GLYCERIN .525 mL/mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient] E 20171231 49288-0656_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0656 HUMAN PRESCRIPTION DRUG Treatment Set TS329678 Treatment Set TS329678 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN 10000; 1000; 10000; .005; .005; .005 [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0657_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0657 HUMAN PRESCRIPTION DRUG Treatment Set TS333938 Treatment Set TS333938 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; AMBROSIA TRIFIDA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; IVA XANTHIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; FAGUS GRANDIFOLIA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; CARPINUS CAROLINIANA POLLEN; PICEA PUNGENS POLLEN; ACER NEGUNDO POLLEN; PINUS STROBUS POLLEN; CELTIS OCCIDENTALIS POLLEN; ACER SACCHARUM POLLEN; JUNIPERUS ASHEI POLLEN; BETULA PAPYRIFERA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER RUBRUM POLLEN; MORUS RUBRA POLLEN; JUNIPERUS PINCHOTII POLLEN; CARYA OVATA POLLEN; ACER SACCHARINUM POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; AILANTHUS ALTISSIMA POLLEN; FRAXINUS AMERICANA POLLEN; CARYA ALBA POLLEN; MORUS ALBA POLLEN; POPULUS ALBA POLLEN; ALTERNARIA ALTERNATA; ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS REPENS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; MUCOR RACEMOSUS; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM EXPANSUM; PENICILLIUM ITALICUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM ROQUEFORTI; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; CYNODON DACTYLON POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; POA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; POA COMPRESSA POLLEN; TYPHA LATIFOLIA POLLEN; BROMUS SECALINUS POLLEN; ZEA MAYS POLLEN; SECALE CEREALE POLLEN; TRITICUM AESTIVUM POLLEN; SORGHUM HALEPENSE POLLEN; ELYMUS REPENS POLLEN; PHALARIS ARUNDINACEA POLLEN; BROMUS INERMIS POLLEN; SORGHUM BICOLOR SSP. DRUMMONDII POLLEN; ARRHENATHERUM ELATIUS POLLEN; HOLCUS LANATUS POLLEN; PASCOPYRUM SMITHII POLLEN 1000; .00125; .00125; .00125; .00125; .0025; .0025; .005; .005; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .001; .00025; .00025; .00025; .00025; .001; .001; .001; .001; .00017; .00017; .00017; .00017; .00017; .00017; .001; .001; .001; 45.5; 454.5; 454.5; 454.5; 454.5; 454.5; 454.5; 454.5; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227 [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0658_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0658 HUMAN PRESCRIPTION DRUG Treatment Set TS128872 Treatment Set TS128872 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; KOCHIA SCOPARIA POLLEN; FAGUS GRANDIFOLIA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; CARPINUS CAROLINIANA POLLEN; PICEA PUNGENS POLLEN; ACER NEGUNDO POLLEN; PINUS STROBUS POLLEN; CELTIS OCCIDENTALIS POLLEN; ACER SACCHARUM POLLEN; JUNIPERUS ASHEI POLLEN; BETULA PAPYRIFERA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER RUBRUM POLLEN; MORUS RUBRA POLLEN; JUNIPERUS PINCHOTII POLLEN; CARYA OVATA POLLEN; ACER SACCHARINUM POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; AILANTHUS ALTISSIMA POLLEN; FRAXINUS AMERICANA POLLEN; CARYA ALBA POLLEN; MORUS ALBA POLLEN; POPULUS ALBA POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; FESTUCA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; PHLEUM PRATENSE POLLEN; POA COMPRESSA POLLEN; TYPHA LATIFOLIA POLLEN; BROMUS SECALINUS POLLEN; ZEA MAYS POLLEN; SECALE CEREALE POLLEN; TRITICUM AESTIVUM POLLEN; SORGHUM HALEPENSE POLLEN; ELYMUS REPENS POLLEN; PHALARIS ARUNDINACEA POLLEN; BROMUS INERMIS POLLEN; SORGHUM BICOLOR SSP. DRUMMONDII POLLEN; ARRHENATHERUM ELATIUS POLLEN; HOLCUS LANATUS POLLEN; PASCOPYRUM SMITHII POLLEN; ARTEMISIA VULGARIS POLLEN; ARTEMISIA ABSINTHIUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA LUDOVICIANA POLLEN; IVA XANTHIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN .00125; .00125; .00125; .00125; .00125; .00125; .00125; .00125; .005; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; 1045.5; 454.5; 454.5; 454.5; 454.5; 454.5; 454.5; 454.5; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .000227; .00125; .00125; .00125; .00125; .0025; .0025; .0025; .0025 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] E 20171231 49288-0659_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0659 HUMAN PRESCRIPTION DRUG Treatment Set TS128871 Treatment Set TS128871 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES; ACREMONIUM STRICTUM; TRICHOTHECIUM ROSEUM; PASSALORA FULVA; COCHLIOBOLUS SPICIFER; MYROTHECIUM VERRUCARIA; HYPOMYCES PERNICIOSUS; NEUROSPORA CRASSA; KHUSKIA ORYZAE; PAECILOMYCES VARIOTII; MICROASCUS BREVICAULIS; COLLETOTRICHUM COCCODES; PLEOSPORA HERBARUM; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE; TRICHOPHYTON SCHOENLEINII; MYCOCLADUS CORYMBIFERUS; ACROTHECIUM ROBUSTUM; HUMICOLA GRISEA; MICROSPORUM AUDOUINII; MICROSPORUM CANIS; APIOSPORA MONTAGNEI; PHYCOMYCES BLAKESLEEANUS; SPOROTRICHUM PRUINOSUM; STACHYBOTRYS CHARTARUM; SYNCEPHALASTRUM RACEMOSUM; TETRACOCCOSPORIUM PAXIANUM; VERTICILLIUM ALBO-ATRUM; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR .005; .005; .00036; .00036; .00036; .00036; .00036; .00036; .00036; .00036; .00036; .00036; .00036; .00036; .00036; .00036; .00042; .00042; .00042; .00042; .00042; .00042; .00042; .00042; .00042; .00042; .00042; .00042; .0025; .0025; .005; 500 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0660_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0660 HUMAN PRESCRIPTION DRUG Treatment Set TS128873 Treatment Set TS128873 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM BOTRYS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; IVA XANTHIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN; FAGUS GRANDIFOLIA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; CARPINUS CAROLINIANA POLLEN; PICEA PUNGENS POLLEN; ACER NEGUNDO POLLEN; PINUS STROBUS POLLEN; CELTIS OCCIDENTALIS POLLEN; ACER SACCHARUM POLLEN; JUNIPERUS ASHEI POLLEN; BETULA PAPYRIFERA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER RUBRUM POLLEN; MORUS RUBRA POLLEN; JUNIPERUS PINCHOTII POLLEN; CARYA OVATA POLLEN; ACER SACCHARINUM POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; AILANTHUS ALTISSIMA POLLEN; FRAXINUS AMERICANA POLLEN; CARYA ALBA POLLEN; MORUS ALBA POLLEN; POPULUS ALBA POLLEN .00125; .00125; .00125; .00125; .00125; .00125; .00125; .00125; .005; .00167; .00167; .00167; .0025; .0025; .005; .005; .0025; .0025; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021; .00021 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] E 20171231 49288-0661_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0661 HUMAN PRESCRIPTION DRUG Treatment Set TS128870 Treatment Set TS128870 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; EQUUS CABALLUS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR .005; .005; 300; 500 g/mL; g/mL; [AU]/mL; [BAU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] E 20171231 49288-0662_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0662 HUMAN PRESCRIPTION DRUG Treatment Set TS330718 Treatment Set TS330718 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; PERIPLANETA AMERICANA; ASPERGILLUS FUMIGATUS; MUCOR RACEMOSUS; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; MORUS ALBA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PLANTAGO LANCEOLATA POLLEN; SALSOLA KALI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; URTICA DIOICA POLLEN 80; 80; 16; .00008; 80; 4000; .002; .0004; .002; .002; .002; .002; .002; .002; .002; .002; 800; .002; .002; .002; .002; .002 [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0663_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0663 HUMAN PRESCRIPTION DRUG Treatment Set TS333400 Treatment Set TS333400 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ASPERGILLUS FUMIGATUS; PHLEUM PRATENSE POLLEN 2000; .01; .01; 20000 [BAU]/mL; g/mL; g/mL; [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0664_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0664 HUMAN PRESCRIPTION DRUG Treatment Set TS331884 Treatment Set TS331884 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; PERIPLANETA AMERICANA 2000; 2000; .01 [AU]/mL; [AU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0665_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0665 HUMAN PRESCRIPTION DRUG Treatment Set TS331413 Treatment Set TS331413 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PHLEUM PRATENSE POLLEN; CYNODON DACTYLON POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; JUNIPERUS ASHEI POLLEN; JUGLANS NIGRA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN 800; 1000; 10000; .005; .005; .005; .005; .002; .002 [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0666_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0666 HUMAN PRESCRIPTION DRUG Treatment Set TS333541 Treatment Set TS333541 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; JUNIPERUS ASHEI POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN 2000; .01; 20000; .01 [BAU]/mL; g/mL; [AU]/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0667_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0667 HUMAN PRESCRIPTION DRUG Treatment Set TS333312 Treatment Set TS333312 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ACER NEGUNDO POLLEN; PLATANUS OCCIDENTALIS POLLEN; FRAXINUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN .002; .01; .01; .01; 80; 800 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0668_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0668 HUMAN PRESCRIPTION DRUG Treatment Set TS332975 Treatment Set TS332975 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR 400; .01 [BAU]/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0669_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0669 HUMAN PRESCRIPTION DRUG Treatment Set TS333635 Treatment Set TS333635 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA; ACER NEGUNDO POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN .005; .005; .005; .005; .005; .002; .005; .005; .005; 10000 g/mL; g/mL; g/mL; g/mL; g/mL; [Amb'a'1'U]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0670_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0670 HUMAN PRESCRIPTION DRUG Treatment Set TS332406 Treatment Set TS332406 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; PERIPLANETA AMERICANA; AMBROSIA ARTEMISIIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; MORUS ALBA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; IVA ANNUA VAR. ANNUA POLLEN 400; .002; 4000; .002; .002; .002; .002; .002; .002; .002; .002; .002; .002; .002; 400; 4000; .002; .002; .002 [AU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0671_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0671 HUMAN PRESCRIPTION DRUG Treatment Set TS332499 Treatment Set TS332499 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN .002; .002; 400; .002; .002; .002; .002; .002; .002; .002; 4000; 4000 g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0672_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0672 HUMAN PRESCRIPTION DRUG Treatment Set TS332229 Treatment Set TS332229 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLADOSPORIUM HERBARUM; PHLEUM PRATENSE POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; CYNODON DACTYLON POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; IVA ANNUA VAR. ANNUA POLLEN 400; 400; .002; .0004; .002; .002; .002; .002; 4000; .002; .002; .002; .002; .002; .002; .002; .002; .001; .001; 400; 4000; .002; .002; .002 [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0673_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0673 HUMAN PRESCRIPTION DRUG Treatment Set TS332090 Treatment Set TS332090 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; IVA ANNUA VAR. ANNUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN 400; 400; .002; 400; .002; .002; .002; .002; .002; .001; .001; 400; 4000; 4000 [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0674_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0674 HUMAN PRESCRIPTION DRUG Treatment Set TS332091 Treatment Set TS332091 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091221 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLADOSPORIUM HERBARUM; ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; ACER NEGUNDO POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; SALSOLA KALI POLLEN 400; 400; .002; .002; .002; .002; .002; .0004; .002; .002; .002; .002; .002; .002; .001; .001; 400; 4000; 4000; .002 [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0675_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0675 HUMAN PRESCRIPTION DRUG Treatment Set TS128811 Treatment Set TS128811 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; POA PRATENSIS POLLEN; FESTUCA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ULMUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; JUGLANS NIGRA POLLEN .0025; .0025; 1428.6; 1428.6; 1428.6; 1428.6; 1428.6; 1428.6; 1428.6; .005; .005; .005; .005 g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0676_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0676 HUMAN PRESCRIPTION DRUG Treatment Set TS129085 Treatment Set TS129085 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. MORUS RUBRA POLLEN; ULMUS AMERICANA POLLEN; ACER RUBRUM POLLEN; QUERCUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CLADOSPORIUM CLADOSPORIOIDES; MUCOR RACEMOSUS; CARYA ALBA POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; PLEOSPORA HERBARUM .002; .0004; .0004; .0004; .0004; 80; 32; .00008; .0004; .002; .0004; 800; .0004; .0004; 120; .0004; .002; .002; .002; 120; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0677_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0677 HUMAN PRESCRIPTION DRUG Treatment Set TS329595 Treatment Set TS329595 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR; AMBROSIA ARTEMISIIFOLIA POLLEN .05; 800 g/mL; [AU]/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0678_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0678 HUMAN PRESCRIPTION DRUG Treatment Set TS129259 Treatment Set TS129259 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 400; 2000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0679_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0679 HUMAN PRESCRIPTION DRUG Treatment Set TS331657 Treatment Set TS331657 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; FELIS CATUS HAIR; DACTYLIS GLOMERATA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; POA PRATENSIS POLLEN; IVA ANNUA VAR. ANNUA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; ALNUS RHOMBIFOLIA POLLEN; JUNIPERUS ASHEI POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN .002; 400; 4000; 800; .002; .002; .002; 4000; .002; 4000; 4000; 4000; .002; .002; .001; .001 g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0680_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0680 HUMAN PRESCRIPTION DRUG Treatment Set TS333519 Treatment Set TS333519 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN; CYNODON DACTYLON POLLEN; LOLIUM PERENNE POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; DACTYLIS GLOMERATA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN 4000; 2000; 4000; 4000; .01; 2000; 4000; 4000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [AU]/mL; [BAU]/mL; [AU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0681_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0681 HUMAN PRESCRIPTION DRUG Treatment Set TS333743 Treatment Set TS333743 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN; SALSOLA KALI POLLEN; ALNUS RHOMBIFOLIA POLLEN; BOS TAURUS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; CLADOSPORIUM HERBARUM; ACER NEGUNDO POLLEN; FELIS CATUS HAIR; DACTYLIS GLOMERATA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; QUERCUS ALBA POLLEN; POA PRATENSIS POLLEN; EPICOCCUM NIGRUM .002; 400; 4000; 4000; .002; .002; .002; .002; 400; 400; .002; .002; 400; 4000; 4000; .002; .002; 4000; .002 g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0682_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0682 HUMAN PRESCRIPTION DRUG Treatment Set TS329802 Treatment Set TS329802 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ACER NEGUNDO POLLEN; PERIPLANETA AMERICANA; DACTYLIS GLOMERATA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; BETULA POPULIFOLIA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; POA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; CYNODON DACTYLON POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; SALSOLA KALI POLLEN; JUNIPERUS ASHEI POLLEN; POPULUS DELTOIDES POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; EPICOCCUM NIGRUM; COCHLIOBOLUS SATIVUS 400; .002; .002; .002; 4000; 4000; .002; .002; .002; 4000; 4000; 400; 4000; 4000; .002; .002; .002; .002; .002; .001; .001; .002; .002 [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0683_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0683 HUMAN PRESCRIPTION DRUG Treatment Set TS330316 Treatment Set TS330316 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; BOS TAURUS HAIR; SUS SCROFA HAIR; CAPRA HIRCUS HAIR; MUCOR RACEMOSUS 400; 400; 400; .002; .002; .002; .002; .002; .002 [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0684_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0684 HUMAN PRESCRIPTION DRUG Treatment Set TS330317 Treatment Set TS330317 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; MORUS ALBA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; IVA ANNUA VAR. ANNUA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; SORGHUM HALEPENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; RUMEX ACETOSELLA POLLEN; ALNUS RHOMBIFOLIA POLLEN .002; .002; .002; .002; .002; .002; .002; .002; .001; .001; .002; 400; 4000; 4000; .002; .002; .002; 4000; 4000; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0685_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0685 HUMAN PRESCRIPTION DRUG Treatment Set TS333001 Treatment Set TS333001 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PHLEUM PRATENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA ALBA POLLEN; QUERCUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS CALIFORNICA POLLEN 400; .002; 4000; .002; .002; .002; 4000; .002; .002; .002; .002; .002; .002; .002 [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0686_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0686 HUMAN PRESCRIPTION DRUG Treatment Set TS331802 Treatment Set TS331802 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; SALSOLA KALI POLLEN .005; .005; .005; .005; .005; 10000; .005 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0687_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0687 HUMAN PRESCRIPTION DRUG Treatment Set TS330170 Treatment Set TS330170 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; SORGHUM HALEPENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; JUNIPERUS ASHEI POLLEN; BOS TAURUS HAIR; SUS SCROFA HAIR; CAPRA HIRCUS HAIR 400; 800; 4000; .002; 800; 800; .002; .0002; 400; .002; .002; .002; .002; .002 [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0688_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0688 HUMAN PRESCRIPTION DRUG Treatment Set TS329123 Treatment Set TS329123 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; CYNODON DACTYLON POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; SORGHUM HALEPENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; SALSOLA KALI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; MUCOR RACEMOSUS; MORUS ALBA POLLEN; PERIPLANETA AMERICANA 4000; .002; .002; .002; .002; .002; .002; .002; .002; .002; 4000; 400; 4000; 4000; .002; .002; .002; .002; .002; .002; .001; .001; .002; .002; .002 [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0689_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0689 HUMAN PRESCRIPTION DRUG Treatment Set TS331579 Treatment Set TS331579 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA 400; .002; .01 [BAU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0690_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0690 HUMAN PRESCRIPTION DRUG Treatment Set TS329894 Treatment Set TS329894 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; FELIS CATUS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; PLATANUS OCCIDENTALIS POLLEN; MORUS RUBRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN .00017; 1.33; 833.33; .0083; .0083; .0083; 16666 g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; [AU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0691_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0691 HUMAN PRESCRIPTION DRUG Treatment Set TS333308 Treatment Set TS333308 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; CYNODON DACTYLON POLLEN; ULMUS AMERICANA POLLEN; ACER RUBRUM POLLEN; CARYA ALBA POLLEN; CARYA ALBA POLLEN; MORUS ALBA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; QUERCUS ALBA POLLEN 80; 80; 80; 80; .002; .002; .002; .0004; .002; 800; .0004; 160; .0004; .0004 [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0692_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0692 HUMAN PRESCRIPTION DRUG Treatment Set TS332780 Treatment Set TS332780 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; CYNODON DACTYLON POLLEN; QUERCUS ALBA POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PLANTAGO LANCEOLATA POLLEN; SALSOLA KALI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN 16; 3.2; 3.2; .0002; 6.4; .000016; 160; .0002; .0002; .0002; .0002 [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0693_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0693 HUMAN PRESCRIPTION DRUG Treatment Set TS329905 Treatment Set TS329905 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; KOCHIA SCOPARIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN 66.67; .0017; .0017; .0017; .0017; .00056; .00056; .00056; .0017; .0017; .00083; .00083; .0017; .0017; .0017; .0017; .0017; .0003; .0003; 666.67; .0003; .0017 [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0694_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0694 HUMAN PRESCRIPTION DRUG Treatment Set TS329906 Treatment Set TS329906 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FUSARIUM OXYSPORUM; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; PLEOSPORA HERBARUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; RHIZOPUS STOLONIFER; PHOMA DESTRUCTIVA; DERMATOPHAGOIDES PTERONYSSINUS; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .00083; .00083; .00083; .00083; .00017; .00042; .00042; .00083; .00083; .00083; .00083; .00083; .00083; 166.67; .00083; .00083; 166.67; 166.67; .00021; .00021; .00021; .00021; .00028; .00028; .00028 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0695_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0695 HUMAN PRESCRIPTION DRUG Treatment Set TS332509 Treatment Set TS332509 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .002; .002; .002; .002; 4000; 400; .002; 16; 16; 400; .000668; .000668; .000668 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 49288-0696_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0696 HUMAN PRESCRIPTION DRUG Treatment Set TS330370 Treatment Set TS330370 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FUSARIUM OXYSPORUM; CLADOSPORIUM CLADOSPORIOIDES; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; COCHLIOBOLUS SATIVUS; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; SORGHUM HALEPENSE POLLEN; PERIPLANETA AMERICANA; RHIZOPUS STOLONIFER; PHOMA DESTRUCTIVA; DERMATOPHAGOIDES PTERONYSSINUS; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PLEOSPORA HERBARUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .0008; .0008; 3333.33; 333.33; .0008; .0008; .0008; .0017; .0008; .0008; .0008; 333.33; .0008; .00017; 333.33; 33.33; .00042; .00042; .00021; .00021; .00021; .00021; .0008; .0008; .0008; .00028; .00028; .00028 g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0697_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0697 HUMAN PRESCRIPTION DRUG Treatment Set TS330359 Treatment Set TS330359 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. KOCHIA SCOPARIA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; IVA ANNUA VAR. ANNUA POLLEN; RUMEX ACETOSELLA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN .0017; .00083; .00083; .0017; .0017; .0017; .0017; .00011; .00011; .00011; .0017; .0017; .0017; .0017; .0017; .0017; .0017; .0017; .0017 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0698_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0698 HUMAN PRESCRIPTION DRUG Treatment Set TS330454 Treatment Set TS330454 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM ALBUM POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; ACER NEGUNDO POLLEN; FRAXINUS AMERICANA POLLEN; BETULA NIGRA POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; PLEOSPORA HERBARUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR .00033; .0000044; .0000044; .0000044; .0083; .0017; .00017; .00017; .000133; .00033; .000133; 66.67; .000133; .0021; .0021; .00017; .00083; .0042; 33.33; .00017; 33.33; 33.33 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [AU]/mL; [BAU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0699_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0699 HUMAN PRESCRIPTION DRUG Treatment Set TS330583 Treatment Set TS330583 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; RUMEX ACETOSELLA POLLEN .001; .001; 4000; 400; .00008; 80; 80; .002 g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0700_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0700 HUMAN PRESCRIPTION DRUG Treatment Set TS331977 Treatment Set TS331977 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUGLANS NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN .0083; .0017; .0017; .0083; .0083; .0017; .00083; .00083; 16666.67; 133.33; .0017 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0701_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0701 HUMAN PRESCRIPTION DRUG Treatment Set TS331955 Treatment Set TS331955 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN 26.67; 2.67; .0000133 [BAU]/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0702_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0702 HUMAN PRESCRIPTION DRUG Treatment Set TS332080 Treatment Set TS332080 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN .00033; 666.67; 66.67; .00033; .00033; .00033; .00033 g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0703_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0703 HUMAN PRESCRIPTION DRUG Treatment Set TS332594 Treatment Set TS332594 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; SORGHUM HALEPENSE POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; POPULUS DELTOIDES POLLEN; RUMEX ACETOSELLA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; KOCHIA SCOPARIA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN .0000133; .0000066; .0000066; .0000133; 2.67; 26.67; .0000133; .0000133; .0000066; .0000066; .0000133; .0000133; .00033; .0000133; .0000133; .0000133; .0000133; .0000133; .0000133; .0000133; .0000133 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0704_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0704 HUMAN PRESCRIPTION DRUG Treatment Set TS331046 Treatment Set TS331046 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLADOSPORIUM HERBARUM; ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ACER NEGUNDO POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; JUNIPERUS ASHEI POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; IVA ANNUA VAR. ANNUA POLLEN .0042; .0000333; .00083; .00017; 166.67; .00083; .0017; .000165; .000165; 333.33; 666.67; .0017; .0017; .0017; .0017; .00033; .0017; .00033; 133.33; .0017; .0017; .0017 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0705_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0705 HUMAN PRESCRIPTION DRUG Treatment Set TS330376 Treatment Set TS330376 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; QUERCUS ALBA POLLEN; CLADOSPORIUM CLADOSPORIOIDES; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; SORGHUM HALEPENSE POLLEN; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; PLEOSPORA HERBARUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; RHIZOPUS STOLONIFER; PHOMA DESTRUCTIVA; DERMATOPHAGOIDES PTERONYSSINUS; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .00033; .0000044; .0000044; .0000044; .00033; .00017; 133.33; 66.67; .00017; .00017; .00033; .000415; .000415; .00083; .00083; .00083; .00083; .00021; .00021; .00021; .00021; .00083; .00083; 166.67; .00083; .00083; 166.67; 33.33; .00028; .00028; .00028 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0706_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0706 HUMAN PRESCRIPTION DRUG Treatment Set TS333246 Treatment Set TS333246 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; MUCOR RACEMOSUS; ALTERNARIA ALTERNATA; PLEOSPORA HERBARUM; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; ACER RUBRUM POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PLANTAGO LANCEOLATA POLLEN; SALSOLA KALI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; CANDIDA ALBICANS; COCHLIOBOLUS SATIVUS; FUSARIUM OXYSPORUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; EPICOCCUM NIGRUM 400; 80; .002; 80; 160; .0004; .002; .00008; .004; .002; .004; .004; .002; .002; 800; .002; .002; .004; .004; .002; .002; .002; .002; .002 [AU]/mL; [BAU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0707_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0707 HUMAN PRESCRIPTION DRUG Treatment Set TS331810 Treatment Set TS331810 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; JUNIPERUS ASHEI POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; MORUS ALBA POLLEN; URTICA DIOICA POLLEN .0083; .00085; .00085; .0017; .0083; .0083; .0017; .0083; .0083 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0708_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0708 HUMAN PRESCRIPTION DRUG Treatment Set TS331632 Treatment Set TS331632 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLADOSPORIUM HERBARUM; ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; JUNIPERUS ASHEI POLLEN; FRAXINUS AMERICANA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; IVA ANNUA VAR. ANNUA POLLEN 833.33; .00083; .00017; .00083; .00017; .00083; 333.33; 3333.33; .000067; .0083; 666.67; .0083; .0017 [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0709_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0709 HUMAN PRESCRIPTION DRUG Treatment Set TS332626 Treatment Set TS332626 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; MORUS ALBA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; IVA ANNUA VAR. ANNUA POLLEN; RUMEX ACETOSELLA POLLEN; URTICA DIOICA POLLEN 166.67; 166.67; 33.33; .00083; .0042; .00033; .0017; .00033; .00033; .0017; .0017; .00033; .00033; .00085; .00085; .0083; 66.67; 666.67; 133.33; .0017; .00033; .00033; .00033; .0017 [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0710_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0710 HUMAN PRESCRIPTION DRUG Treatment Set TS333315 Treatment Set TS333315 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; POA PRATENSIS POLLEN; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; CHENOPODIUM ALBUM POLLEN; ULMUS AMERICANA POLLEN; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .00011; .00011; .00011; 8333.33; .0042; .0042; 833.33; .0042; 833.33; 833.33; .00033; .00033; .0021; .0021; .0014; .0014; .0014 g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 49288-0711_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0711 HUMAN PRESCRIPTION DRUG Treatment Set TS330453 Treatment Set TS330453 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; KOCHIA SCOPARIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; FUSARIUM OXYSPORUM; CLADOSPORIUM CLADOSPORIOIDES; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; COCHLIOBOLUS SATIVUS; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; SORGHUM HALEPENSE POLLEN .002; .002; .002; .002; .00067; .00067; .00067; .002; .002; .002; .002; .001; .001; .002; .002; .002; .002; .002; .002; .002; .002; .002; 4000; 400; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC] E 20171231 49288-0712_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0712 HUMAN PRESCRIPTION DRUG Treatment Set TS329388 Treatment Set TS329388 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR .0083; 333.33; .0017; 166.67; 166.67; 1.33 g/mL; [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] E 20171231 49288-0713_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0713 HUMAN PRESCRIPTION DRUG Treatment Set TS331327 Treatment Set TS331327 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; PLANTAGO LANCEOLATA POLLEN; CYNODON DACTYLON POLLEN; ASPERGILLUS FUMIGATUS; SORGHUM HALEPENSE POLLEN; ALTERNARIA ALTERNATA 160; .002; 400; .002; .00008; .002 [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0714_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0714 HUMAN PRESCRIPTION DRUG Treatment Set TS332256 Treatment Set TS332256 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN; URTICA DIOICA POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; IVA ANNUA VAR. ANNUA POLLEN .00167; .00167; 333.33; 16666.67; .00167; .00833; .00167; .00033; 133.33; .00167; .00167; .00833; .00167; .00167; .000833; .000833; .00167; .00033 g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0715_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0715 HUMAN PRESCRIPTION DRUG Treatment Set TS331153 Treatment Set TS331153 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; KOCHIA SCOPARIA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; ACER NEGUNDO POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; BETULA NIGRA POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN .002; .002; .002; .002; .002; .002; .001; .001; .002; .002; .002; .002; 160; 400; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0716_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0716 HUMAN PRESCRIPTION DRUG Treatment Set TS329151 Treatment Set TS329151 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; KOCHIA SCOPARIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN .0000133; .0000133; .00167; .00167; .0000044; .0000044; .0000044; .0000133; .000067; .00167; .00083; .00083; .00167; .00167; .00167; .00167; .00167; .0000133; .00167; 3333.33; 333.33; .0000133 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0717_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0717 HUMAN PRESCRIPTION DRUG Treatment Set TS329152 Treatment Set TS329152 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FUSARIUM OXYSPORUM; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; PLEOSPORA HERBARUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PERIPLANETA AMERICANA; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; RHIZOPUS STOLONIFER; PHOMA DESTRUCTIVA; DERMATOPHAGOIDES PTERONYSSINUS; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .000833; .000833; .000833; .000833; .000833; .0004167; .0004167; .000833; .000833; .000833; .000833; .0002083; .0002083; .0002083; .0002083; .000833; .000833; 166.67; .000833; .000833; 166.67; 166.67; .0002783; .0002783; .002783 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0718_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0718 HUMAN PRESCRIPTION DRUG Treatment Set TS332147 Treatment Set TS332147 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; KOCHIA SCOPARIA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; SALSOLA KALI POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; SORGHUM HALEPENSE POLLEN; FELIS CATUS HAIR; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .0004; .002; .0000267; .0000267; .0000267; .002; .001; .001; 800; 400; .002; .002; .002; 400; .00067; .00067; .00067 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 49288-0719_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0719 HUMAN PRESCRIPTION DRUG Treatment Set TS330836 Treatment Set TS330836 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. SALSOLA KALI POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; POA PRATENSIS POLLEN .00167; .00033; .00033; .00033; 3333.33 g/mL; g/mL; g/mL; g/mL; [BAU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0720_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0720 HUMAN PRESCRIPTION DRUG Treatment Set TS331634 Treatment Set TS331634 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; CYNODON DACTYLON POLLEN; ALTERNARIA ALTERNATA; SORGHUM HALEPENSE POLLEN; IVA ANNUA VAR. ANNUA POLLEN; COCHLIOBOLUS SATIVUS; PHOMA DESTRUCTIVA; PLEOSPORA HERBARUM 2000; 80; .0004; .01; .01; .002; .002; .002 [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0721_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0721 HUMAN PRESCRIPTION DRUG Treatment Set TS330927 Treatment Set TS330927 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; DERMATOPHAGOIDES PTERONYSSINUS; CANDIDA ALBICANS; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PLEOSPORA HERBARUM; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM 400; .002; .002; .002; .00067; .00067; .00067; 400; .00008; .00002; .00002; .00002; .00002; .00008; .001; .001 [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0722_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0722 HUMAN PRESCRIPTION DRUG Treatment Set TS330928 Treatment Set TS330928 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN .00067; .00067; .00067; 400; .002; .00008; .002; .002; .001; .001; .002; .00008; .00008; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0723_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0723 HUMAN PRESCRIPTION DRUG Treatment Set TS331455 Treatment Set TS331455 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. PERIPLANETA AMERICANA; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; BETULA NIGRA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CHENOPODIUM ALBUM POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; POA PRATENSIS POLLEN; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI .002; .00067; .00067; .00067; 400; 400; 80; .002; .002; .002; .002; .002; .001; .001; .002; .00013; .00013; .00013; .002; .002; .002; .002; 80; .0004; 800; .002; .002; .0005; .0005; .0005; .0005 g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0724_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0724 HUMAN PRESCRIPTION DRUG Treatment Set TS331621 Treatment Set TS331621 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; POA PRATENSIS POLLEN; PERIPLANETA AMERICANA; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; JUNIPERUS VIRGINIANA POLLEN; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PLEOSPORA HERBARUM; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN 400; 160; .002; 16; 80; .00008; .002; .0004; .0004; .00004; .00004; .0004; .0004; .00004; .00004; .002; .002; .002; .0004; .0004; .0004; .0004; .002; .002; .002; .0004; .002 [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0725_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0725 HUMAN PRESCRIPTION DRUG Treatment Set TS330171 Treatment Set TS330171 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20091218 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ULMUS AMERICANA POLLEN; PLANTAGO LANCEOLATA POLLEN; SORGHUM HALEPENSE POLLEN; POA PRATENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; ACER NEGUNDO POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; SALSOLA KALI POLLEN 80; 160; .002; .002; .0004; 800; .0004; .002; 800; 800; 800; .0004 [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0726_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0726 HUMAN PRESCRIPTION DRUG Treatment Set TS329197 Treatment Set TS329197 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ULMUS AMERICANA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; BETULA NIGRA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; SORGHUM HALEPENSE POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN .00008; .00013; .00013; .00013; 16; 4000; .002; .002; .002; .002; .00004; .00004; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0727_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0727 HUMAN PRESCRIPTION DRUG Treatment Set TS330416 Treatment Set TS330416 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; CANDIDA ALBICANS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; QUERCUS ALBA POLLEN; PLEOSPORA HERBARUM; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM .0000267; .0000267; .0000267; .0004; .002; .00067; .00067; .00067; 400; .00008; .00008; .002; .002; .002; .002; .002; .00008; .001; .001; .00008; .002; .00008; .002; .00008; .00008; .00008; .002; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] E 20171231 49288-0728_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0728 HUMAN PRESCRIPTION DRUG Treatment Set TS329467 Treatment Set TS329467 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; ACER NEGUNDO POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PLEOSPORA HERBARUM; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; RUMEX ACETOSELLA POLLEN; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM .002; .00008; .002; .002; .002; .002; .002; .00008; .002; .001; .001; .002; .00002; .00002; .00002; .00002; .00008; .002; .0004; .002; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 49288-0729_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0729 HUMAN PRESCRIPTION DRUG Treatment Set TS332343 Treatment Set TS332343 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN 160; .00008; .0000267; .0000267; .0000267; 16; .002; .00008; .00008; .00008; .00004; .00004; .00008; .00008; .00008; .00008; .00008; .00008; .00008; .00008; .00008; .00008 [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0730_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0730 HUMAN PRESCRIPTION DRUG Treatment Set TS332344 Treatment Set TS332344 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; ASPERGILLUS FUMIGATUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PLEOSPORA HERBARUM; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM 16; 400; .00008; .002; 400; .002; .002; .00002; .00002; .00002; .00002; .00008; .00004; .00004 [BAU]/mL; [AU]/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0731_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0731 HUMAN PRESCRIPTION DRUG Treatment Set TS329066 Treatment Set TS329066 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CANIS LUPUS FAMILIARIS HAIR; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; DERMATOPHAGOIDES PTERONYSSINUS; PLANTAGO LANCEOLATA POLLEN; CANDIDA ALBICANS; JUNIPERUS VIRGINIANA POLLEN; ASPERGILLUS FUMIGATUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; ACER NEGUNDO POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; PLEOSPORA HERBARUM 4000; .00013; .00013; .00013; .002; .00067; .00067; .00067; 400; .00008; .002; .00008; .002; .002; .002; .002; .002; .002; .002 [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0732_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0732 HUMAN PRESCRIPTION DRUG Treatment Set TS329915 Treatment Set TS329915 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; DERMATOPHAGOIDES PTERONYSSINUS; PLANTAGO LANCEOLATA POLLEN; CANDIDA ALBICANS; CLADOSPORIUM CLADOSPORIOIDES; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; FUSARIUM OXYSPORUM 400; 400; .002; 400; .002; .002; .002; .002; .002; .002; .002; .002; .002 [BAU]/mL; [AU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0733_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0733 HUMAN PRESCRIPTION DRUG Treatment Set TS329109 Treatment Set TS329109 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; POA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; ULMUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; QUERCUS ALBA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN .01; 4000; 4000; 20000; .01; .01; .002; 800 g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [AU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0734_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0734 HUMAN PRESCRIPTION DRUG Treatment Set TS329161 Treatment Set TS329161 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PLEOSPORA HERBARUM; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM 16; 16; .00008; .002; .0004; 16; .00008; .0004; .0004; .00008; .00008; .0004; .0004; .00008; .002; .0005; .0005; .0005; .0005; .0004; .001; .001 [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0735_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0735 HUMAN PRESCRIPTION DRUG Treatment Set TS329162 Treatment Set TS329162 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN 160; .0000267; .0000267; .0000267; 16; .00008; .0004; .002; .002; .00004; .00004; .002; .00008; .002; .0004; .002; .002; .002 [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0736_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0736 HUMAN PRESCRIPTION DRUG Treatment Set TS331975 Treatment Set TS331975 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; DERMATOPHAGOIDES FARINAE; ULMUS AMERICANA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; PLANTAGO LANCEOLATA POLLEN; CANDIDA ALBICANS; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN 160; 16; .002; .0000267; .0000267; .0000267; .002; .00008; 400; .00008; .002; .002; .000078; .00008; .00004; .00004; .00008; .00008; .00008; .00002; .00002; .00002; .00002; .002; .00008; .002; .002 [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0737_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0737 HUMAN PRESCRIPTION DRUG Treatment Set TS329526 Treatment Set TS329526 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; QUERCUS ALBA POLLEN; PHLEUM PRATENSE POLLEN; DERMATOPHAGOIDES FARINAE .002; 4000; .0004; 4000; 400 g/mL; [AU]/mL; g/mL; [BAU]/mL; [AU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0738_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0738 HUMAN PRESCRIPTION DRUG Treatment Set TS330503 Treatment Set TS330503 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; POA PRATENSIS POLLEN; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; ULMUS AMERICANA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CYNODON DACTYLON POLLEN; JUNIPERUS VIRGINIANA POLLEN; ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; PLEOSPORA HERBARUM; SORGHUM HALEPENSE POLLEN; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM 400; 160; 16; .00008; .002; .00067; .00067; .00067; .002; .002; .00067; .00067; .00067; 16; .002; .002; .002; .002; .002; .002; .002; .002; .00008; .00008; .001; .001 [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 49288-0739_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0739 HUMAN PRESCRIPTION DRUG Treatment Set TS329750 Treatment Set TS329750 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; POA PRATENSIS POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; JUNIPERUS VIRGINIANA POLLEN; CLADOSPORIUM CLADOSPORIOIDES; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PLEOSPORA HERBARUM; SORGHUM HALEPENSE POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM 16; 160; .0000267; .0000267; .0000267; .0004; .00008; 400; 16; .002; .002; .002; .002; .001; .001; .00008; .002; .002; .0005; .0005; .0005; .0005; .002; .002; .002; .002; .002; .002; .001; .001 [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0740_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0740 HUMAN PRESCRIPTION DRUG Treatment Set TS331150 Treatment Set TS331150 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; JUNIPERUS VIRGINIANA POLLEN; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM 16; 400; .0000267; .0000267; .0000267; .002; 400; 400; .00008; .002; .002; .002; .00008; .002; .002; .00008; .00008; .002; .002; .0004; .002; .002; .001; .001 [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0741_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0741 HUMAN PRESCRIPTION DRUG Treatment Set TS333176 Treatment Set TS333176 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; PLEOSPORA HERBARUM 16; .002; .002; .002; 16; .002; .002; .002; .002; .002; .002; .002; .002 [AU]/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0742_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0742 HUMAN PRESCRIPTION DRUG Treatment Set TS333177 Treatment Set TS333177 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CYNODON DACTYLON POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN 4000; .00067; .00067; .00067; 16; .00008; .00008; .0002; .0002; .00008; .00008; .0004; .002; .002; .002; .002; .002; .002 [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0743_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0743 HUMAN PRESCRIPTION DRUG Treatment Set TS332486 Treatment Set TS332486 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN .00013; .00013; .00013; .0000267; .0000267; 16; .00008; .00008; .00008; .00008; .0004; .002; .002; .002; .002; .002; .00008; .00008; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0744_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0744 HUMAN PRESCRIPTION DRUG Treatment Set TS332487 Treatment Set TS332487 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; COCHLIOBOLUS SATIVUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; PLEOSPORA HERBARUM; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; CANDIDA ALBICANS; FUSARIUM OXYSPORUM; CLADOSPORIUM CLADOSPORIOIDES; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER .0000267; .0000267; .0000267; .0005; .0005; .0005; .0005; .001; .001; .00008; .00008; .00008; .00008; .002; .00008; 16; .002; .00008; .00008; .00008; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient] E 20171231 49288-0745_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0745 HUMAN PRESCRIPTION DRUG Treatment Set TS329227 Treatment Set TS329227 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; DERMATOPHAGOIDES PTERONYSSINUS; ULMUS AMERICANA POLLEN; PLANTAGO LANCEOLATA POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; BETULA NIGRA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; KOCHIA SCOPARIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; CHENOPODIUM ALBUM POLLEN .00013; .00013; .00013; .001; .001; .0005; .0005; .0005; .0005; .001; .001; 400; .002; .002; 16; 160; .002; .002; .002; .002; .00008; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0746_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0746 HUMAN PRESCRIPTION DRUG Treatment Set TS330716 Treatment Set TS330716 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; POA PRATENSIS POLLEN; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN .0000267; .0000267; .0000267; .00004; .00004; 160; .00008; 16; .0004; .00008; .00008; .0004; .00008; .00008; .0004; .00008; .00008; .0004; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0747_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0747 HUMAN PRESCRIPTION DRUG Treatment Set TS330717 Treatment Set TS330717 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; DERMATOPHAGOIDES PTERONYSSINUS; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; PLEOSPORA HERBARUM; RHIZOPUS STOLONIFER; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM 16; .00008; .00008; .00067; .00067; .00067; 16; .00008; 10.00008; .002; .00008; .00008; .002; .00008; .002; .00002; .00002; .00002; .00002; .001; .001 [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient] E 20171231 49288-0748_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0748 HUMAN PRESCRIPTION DRUG Treatment Set TS332340 Treatment Set TS332340 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; PERIPLANETA AMERICANA; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; FRAXINUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POA PRATENSIS POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; KOCHIA SCOPARIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; CANDIDA ALBICANS; COCHLIOBOLUS SATIVUS; RHIZOPUS STOLONIFER; PLEOSPORA HERBARUM .00067; .00067; .00067; .0000267; .0000267; .0000267; .00004; .00004; .001; .001; .002; 16; 16; .0004; 80; .0004; 400; .002; .0004; .00008; .00008; 160; .002; .002; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0749_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0749 HUMAN PRESCRIPTION DRUG Treatment Set TS331258 Treatment Set TS331258 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; POA PRATENSIS POLLEN; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN .0000267; .0000267; .0000267; .00004; .00004; 160; .00008; 16; .00008; .00008; .002; .00008; .00008; .00008; .00008; .00008; .00008; .00008; .002; .0004; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0750_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0750 HUMAN PRESCRIPTION DRUG Treatment Set TS331259 Treatment Set TS331259 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; PLEOSPORA HERBARUM; CLADOSPORIUM CLADOSPORIOIDES; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM .0000267; .0000267; .0000267; .001; .001; .002; .002; 16; .00008; .002; .00008; 16; .00008; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0751_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0751 HUMAN PRESCRIPTION DRUG Treatment Set TS331794 Treatment Set TS331794 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; DERMATOPHAGOIDES PTERONYSSINUS; JUNIPERUS VIRGINIANA POLLEN; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN .001; .001; 400; .002; .01; .01; .00008; .00008; .01; .01 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0752_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0752 HUMAN PRESCRIPTION DRUG Treatment Set TS330533 Treatment Set TS330533 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PLEOSPORA HERBARUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; FELIS CATUS HAIR; RHIZOPUS STOLONIFER; DERMATOPHAGOIDES FARINAE; PHOMA DESTRUCTIVA; FUSARIUM OXYSPORUM; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA .00067; .00067; .00067; .0005; .0005; .0005; .0005; .001; .001; .00008; .00008; .00008; .002; .00008; 16; .0004; 16; .00008; .00008; .002; .002; 16; .002; .00008; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0753_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0753 HUMAN PRESCRIPTION DRUG Treatment Set TS330534 Treatment Set TS330534 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; CYNODON DACTYLON POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLANTAGO LANCEOLATA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; IVA ANNUA VAR. ANNUA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN .001; .001; 400; .00008; .002; .00008; .002; .00008; .002; .002; .002; .002; .002; .002 g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0754_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0754 HUMAN PRESCRIPTION DRUG Treatment Set TS332850 Treatment Set TS332850 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FELIS CATUS HAIR; CLADOSPORIUM CLADOSPORIOIDES; RUMEX ACETOSELLA POLLEN; ASPERGILLUS FUMIGATUS 16; 16; 400; .01; .002; .01 [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0755_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0755 HUMAN PRESCRIPTION DRUG Treatment Set TS332131 Treatment Set TS332131 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; PERIPLANETA AMERICANA; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR; ULMUS AMERICANA POLLEN; PLANTAGO LANCEOLATA POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; ALTERNARIA ALTERNATA; CLADOSPORIUM CLADOSPORIOIDES; BETULA NIGRA POLLEN; POPULUS DELTOIDES POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; KOCHIA SCOPARIA POLLEN; CANDIDA ALBICANS .00013; .00013; .00013; .0004; .00013; .00013; .00013; 3.2; 3.2; .0004; 80; .0004; .0004; 80; 32; .0004; .0004; .0004; .0004; .0004; .0004; .0004; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0756_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0756 HUMAN PRESCRIPTION DRUG Treatment Set TS332507 Treatment Set TS332507 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ULMUS AMERICANA POLLEN; POA PRATENSIS POLLEN; ALTERNARIA ALTERNATA; FRAXINUS AMERICANA POLLEN; BETULA NIGRA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN .0000267; .0000267; .0000267; .002; 160; .01; .00008; .00008; .00008; .002; .00008 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0757_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0757 HUMAN PRESCRIPTION DRUG Treatment Set TS331567 Treatment Set TS331567 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; ALTERNARIA ALTERNATA; JUNIPERUS VIRGINIANA POLLEN; CANDIDA ALBICANS .00013; .00013; .00013; .0002; .0002; 16; 16; .0004; 400; 1000; 10000; .005; .00008; .005 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 49288-0758_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0758 HUMAN PRESCRIPTION DRUG Treatment Set TS331133 Treatment Set TS331133 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PLEOSPORA HERBARUM; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; FELIS CATUS HAIR; POA PRATENSIS POLLEN; ALTERNARIA ALTERNATA; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN .00067; .00067; .00067; .0002; .0002; .0001; .0001; .0001; .0001; .00008; .0002; .0002; 16; 800; .0004; 400; 400; .0004; .00008; .00008; .0004; .00008; .00008; .0004; .0004; .002; .0004; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0759_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0759 HUMAN PRESCRIPTION DRUG Treatment Set TS333374 Treatment Set TS333374 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; SORGHUM HALEPENSE POLLEN; IVA ANNUA VAR. ANNUA POLLEN; CHENOPODIUM ALBUM POLLEN .00067; .00067; .00067; 4000; 16; .00008; .00008; .00008; .002; .00008; .002; .002; .002 g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0760_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0760 HUMAN PRESCRIPTION DRUG Treatment Set TS333373 Treatment Set TS333373 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PLEOSPORA HERBARUM; FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER .00067; .00067; .00067; .00002; .00002; .00002; .00002; .002; .002; .002; .002; .00008; 400; 400; .002; .00008; .00008; 16; .00008; .00008; .00008; .002; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient] E 20171231 49288-0761_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0761 HUMAN PRESCRIPTION DRUG Treatment Set TS332287 Treatment Set TS332287 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; POA PRATENSIS POLLEN; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; IVA ANNUA VAR. ANNUA POLLEN .001; .001; .00067; .00067; .00067; 4000; .002; 16; .00008; .00008; .00008; .0004; .002; .00008; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0762_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0762 HUMAN PRESCRIPTION DRUG Treatment Set TS332291 Treatment Set TS332291 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PLEOSPORA HERBARUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SATIVUS; RHIZOPUS STOLONIFER; PHOMA DESTRUCTIVA; FUSARIUM OXYSPORUM; ASPERGILLUS FUMIGATUS; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA .0000267; .0000267; .0000267; .00002; .00002; .00002; .00002; .0004; .0004; .002; .00008; .002; .002; .00008; .00008; 400; 16; .00008; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient] E 20171231 49288-0763_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0763 HUMAN PRESCRIPTION DRUG Treatment Set TS329240 Treatment Set TS329240 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLEOSPORA HERBARUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; JUNIPERUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; PLANTAGO LANCEOLATA POLLEN; PHOMA DESTRUCTIVA; CANDIDA ALBICANS; KOCHIA SCOPARIA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN .0000267; .0000267; .0000267; .00004; .00004; .00008; .0004; .00008; .00008; .00008; .00008; 160; 80; 400; .0004; .00008; .002; .002; .00008; .00008; .00008; .002; .0004; .002; .002; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0764_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0764 HUMAN PRESCRIPTION DRUG Treatment Set TS333375 Treatment Set TS333375 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; PLANTAGO LANCEOLATA POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; BETULA NIGRA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; SORGHUM HALEPENSE POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; KOCHIA SCOPARIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; CHENOPODIUM ALBUM POLLEN .0000267; .0000267; .0000267; .00004; .00004; .00008; .002; .0004; .002; 80; 160; .00008; .0004; .00008; .00008; .00008; .00008; .00008; .002; .002; .00008; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0765_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0765 HUMAN PRESCRIPTION DRUG Treatment Set TS330821 Treatment Set TS330821 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; JUNIPERUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; PLANTAGO LANCEOLATA POLLEN; FELIS CATUS HAIR; POA PRATENSIS POLLEN; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; PERIPLANETA AMERICANA; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; CANDIDA ALBICANS; ACER NEGUNDO POLLEN; BETULA NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN .0000267; .0000267; .0000267; .001; .001; .00067; .00067; .00067; .00008; .002; .002; 16; 160; 16; .002; .002; 400; 400; .00008; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 49288-0766_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0766 HUMAN PRESCRIPTION DRUG Treatment Set TS330156 Treatment Set TS330156 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PLEOSPORA HERBARUM; CLADOSPORIUM CLADOSPORIOIDES; QUERCUS ALBA POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; FELIS CATUS HAIR; POA PRATENSIS POLLEN; ALTERNARIA ALTERNATA; CYNODON DACTYLON POLLEN; CANDIDA ALBICANS; FUSARIUM OXYSPORUM; ACER NEGUNDO POLLEN; BETULA NIGRA POLLEN; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; SALSOLA KALI POLLEN .0000267; .0000267; .0000267; .001; .001; .001; .001; .0001; .0001; .0001; .0001; .00008; .002; .002; .002; .002; 16; 160; .002; 16; .00008; .002; .002; .002; .00008; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0767_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0767 HUMAN PRESCRIPTION DRUG Treatment Set TS332678 Treatment Set TS332678 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLADOSPORIUM CLADOSPORIOIDES; FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; DERMATOPHAGOIDES PTERONYSSINUS; ASPERGILLUS FUMIGATUS .001; .001; .00067; .00067; .00067; .002; .002; 80; 80; .0004; 80; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; [AU]/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0768_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0768 HUMAN PRESCRIPTION DRUG Treatment Set TS332679 Treatment Set TS332679 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; PLANTAGO LANCEOLATA POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; ACER NEGUNDO POLLEN; RUMEX ACETOSELLA POLLEN; CHENOPODIUM ALBUM POLLEN; SORGHUM HALEPENSE POLLEN; BETULA NIGRA POLLEN; POPULUS DELTOIDES POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; KOCHIA SCOPARIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN .0000267; .0000267; .0000267; .00004; .00004; .00008; .00008; .00008; .00008; .00008; 160; 16; .00008; .002; .002; .0004; .00008; .00008; .0004; .002; .002; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0769_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0769 HUMAN PRESCRIPTION DRUG Treatment Set TS331795 Treatment Set TS331795 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. SPORISORIUM CRUENTUM; USTILAGO CYNODONTIS; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; PLEOSPORA HERBARUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; COCHLIOBOLUS SATIVUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CLADOSPORIUM CLADOSPORIOIDES; RHIZOPUS STOLONIFER; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; PHOMA DESTRUCTIVA; PERIPLANETA AMERICANA; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM .001; .001; .0005; .0005; .0005; .0005; .00067; .00067; .00067; .002; .002; .002; .002; .002; .002; 400; 16; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0770_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0770 HUMAN PRESCRIPTION DRUG Treatment Set TS331796 Treatment Set TS331796 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; JUNIPERUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN .001; .001; .002; .002; .002; 400; .002; .002; .002; .002; .0004; .00008; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0771_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0771 HUMAN PRESCRIPTION DRUG Treatment Set TS329413 Treatment Set TS329413 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. COCHLIOBOLUS SATIVUS; FRAXINUS AMERICANA POLLEN; PERIPLANETA AMERICANA; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; SALSOLA KALI POLLEN; IVA ANNUA VAR. ANNUA POLLEN; CANDIDA ALBICANS .01; .01; .01; 1000; 1000; .01; .01; .01 g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 49288-0772_89f9e682-acd9-4cc7-982d-c32f69b33b07 49288-0772 HUMAN PRESCRIPTION DRUG Treatment Set TS334128 Treatment Set TS334128 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; POPULUS DELTOIDES POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN 160; .00008; .000027; .000027; .000027; .002; .002; 16; .002; .00008; .002; .002; .00008; .00004; .00004; .00008; .00008; .00008; .002; .002; .002; .002 [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0773_b29faef0-2249-45b7-974b-212faa8c91d8 49288-0773 HUMAN PRESCRIPTION DRUG Treatment Set TS334696 Treatment Set TS334696 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. RUMEX ACETOSELLA POLLEN; URTICA DIOICA POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; MORUS ALBA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; IVA ANNUA VAR. ANNUA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN .0000666; .0003333; 33.33; .0008333; .0000666; .0000666; .0000666; .0000666; .0000666; .0000133; .0000666; .0000666; .00833; 13.3333; 666.67; 5.33; .00033; .0000666; .0000666; .0000333; .0000333 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0774_93e07e85-ef26-4a23-a178-148bbd9369e2 49288-0774 HUMAN PRESCRIPTION DRUG Treatment Set TS334946 Treatment Set TS334946 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN 160; .00002666; .00002666; .00002666; 16; .00008; .002; .00008; .002; .00004; .00004; .00008; .0004; .0004; .00008; .002; .0004; .0004; .0004; .002; .00008 [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE] E 20171231 49288-0775_93e07e85-ef26-4a23-a178-148bbd9369e2 49288-0775 HUMAN PRESCRIPTION DRUG Treatment Set TS334947 Treatment Set TS334947 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; DERMATOPHAGOIDES PTERONYSSINUS; ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER; PLEOSPORA HERBARUM .00008; .00008; .00002666; .00002666; .00002666; 16; .00008; .0004; .0004; .0004; .0004; .0004; .00008; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0776_620f9cd6-e5b8-4036-a2dd-388186abade3 49288-0776 HUMAN PRESCRIPTION DRUG Treatment Set TS334972 Treatment Set TS334972 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN .0000133; .000067; .000067; .000033; .000033; .00033; .000067; .0000133; .000067; .0000133; .0000133; .0000133; 26.67; 13.33; .000067 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0777_769ae8c8-2f24-4e91-a9ae-4baf91c5a756 49288-0777 HUMAN PRESCRIPTION DRUG Treatment Set TS335100 Treatment Set TS335100 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; DERMATOPHAGOIDES PTERONYSSINUS; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER; PLEOSPORA HERBARUM; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM 16; .002; .002; .0004; .000027; .000027; .000027; 16; .0004; .002; .002; .002; .002; .002; .002; .002; .00008; .0005; .0005; .0005; .0005; .00004; .00004 [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient] E 20171231 49288-0778_769ae8c8-2f24-4e91-a9ae-4baf91c5a756 49288-0778 HUMAN PRESCRIPTION DRUG Treatment Set TS335101 Treatment Set TS335101 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN 16; .00008; .0004; .00008; .002; .001; .001; .00008; .002; .002; .002; .0004; .0004; .00008; .00008; .0004; .002 [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0779_769ae8c8-2f24-4e91-a9ae-4baf91c5a756 49288-0779 HUMAN PRESCRIPTION DRUG Treatment Set TS335061 Treatment Set TS335061 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; PLANTAGO LANCEOLATA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN .002; .002; .002; .001; .001; .002; .002; .002; .002; .002; .002; .002; 4000; 400; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0780_52150fa7-4a21-4e92-8659-4277b21eff92 49288-0780 HUMAN PRESCRIPTION DRUG Treatment Set TS335657 Treatment Set TS335657 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PLEOSPORA HERBARUM; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM 400; .00008; .00008; 400; 16; .00008; .00008; .00008; .0002; .0002; .002; .002; .002; .00002; .00002; .00002; .00002; .00008; .00008; .00008; .002; .00008; .00008; .00004; .00004 [AU]/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0781_52150fa7-4a21-4e92-8659-4277b21eff92 49288-0781 HUMAN PRESCRIPTION DRUG Treatment Set TS335683 Treatment Set TS335683 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN 2000; 20000 [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0782_7653a564-fc76-4deb-bab0-0897c1851350 49288-0782 HUMAN PRESCRIPTION DRUG Treatment Set TS335823 Treatment Set TS335823 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; PERIPLANETA AMERICANA; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CYNODON DACTYLON POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; PLEOSPORA HERBARUM; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN 160; 16; .00008; .0000266; .0000266; .0000266; .0004; .0006666; .0006666; .0006666; 400; .00008; .00008; .00002; .00002; .00008; .00008; .00008; .0005; .0005; .0005; .0005; .00004; .00004; .00008; .00008; .00008; .004; .002; .002 [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0783_7653a564-fc76-4deb-bab0-0897c1851350 49288-0783 HUMAN PRESCRIPTION DRUG Treatment Set TS335861 Treatment Set TS335861 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; POA PRATENSIS POLLEN; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; ULMUS AMERICANA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; ANSER ANSER FEATHER; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; CYNODON DACTYLON POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; PLANTAGO LANCEOLATA POLLEN; CANDIDA ALBICANS; JUNIPERUS VIRGINIANA POLLEN; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; RHIZOPUS STOLONIFER; FRAXINUS AMERICANA POLLEN; PLEOSPORA HERBARUM 16; 160; 80; .00008; .002; .0000266; .0000266; .0000266; .0004; .0004; .0006666; .0006666; .0006666; 400; 400; .00008; .00008; .0004; .002; .002; .002; .00008; .002 [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0784_84a6e36f-24af-40ed-8dd9-114b1108ccf3 49288-0784 HUMAN PRESCRIPTION DRUG Treatment Set TS336924 Treatment Set TS336924 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLADOSPORIUM HERBARUM; ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ACER NEGUNDO POLLEN; JUGLANS NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; SALSOLA KALI POLLEN 400; 400; .002; .002; .002; .002; 400; .002; .002; .002; .002; .002; .001; .001; 4000; .002 [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0785_84a6e36f-24af-40ed-8dd9-114b1108ccf3 49288-0785 HUMAN PRESCRIPTION DRUG Treatment Set TS336312 Treatment Set TS336312 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ANSER ANSER FEATHER; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BETULA NIGRA POLLEN; QUERCUS ALBA POLLEN; PLEOSPORA HERBARUM; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI .002; .0006666; .0006666; .0006666; .000667; .000667; .000667; .00008; .00008; 400; .002; .002; .001; .001; .002; .002; .002; .002; .002; .00008; .00008; .00008; .00008; .0004; .00008; .00002; .0002; .0002; .00002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0786_51d18fca-e7c9-4032-8120-be71ed6e2a7f 49288-0786 HUMAN PRESCRIPTION DRUG Treatment Set TS336437 Treatment Set TS336437 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; BETULA NIGRA POLLEN; QUERCUS ALBA POLLEN; PLEOSPORA HERBARUM; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; POA PRATENSIS POLLEN; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; RUMEX ACETOSELLA POLLEN .002; .0000266; .0000266; .0000266; 400; .00004; .00004; .00008; .00008; .00008; .00008; .00008; .00008; .00008; .00008; .00008; .00008; .00002; .00002; .00002; .00002; .0002; .0002; 160; .002; 16; .00008; .0008; .00008; .00008; .00008 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient] E 20171231 49288-0787_b4053499-e3af-4991-9c56-5eb96ac94dca 49288-0787 HUMAN PRESCRIPTION DRUG Treatment Set TS336667 Treatment Set TS336667 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PHLEUM PRATENSE POLLEN .002; 4000; 400; .002; 4000 g/mL; [AU]/mL; [BAU]/mL; g/mL; [BAU]/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] E 20171231 49288-0788_b4053499-e3af-4991-9c56-5eb96ac94dca 49288-0788 HUMAN PRESCRIPTION DRUG Treatment Set TS336682 Treatment Set TS336682 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; POA PRATENSIS POLLEN; PASPALUM NOTATUM POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; RHIZOPUS STOLONIFER; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN 400; .005; 80; .0004; 800; .0004; 1000; 1000; .005; 4000; 160; 800 [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0789_b4053499-e3af-4991-9c56-5eb96ac94dca 49288-0789 HUMAN PRESCRIPTION DRUG Treatment Set TS336683 Treatment Set TS336683 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. BETULA POPULIFOLIA POLLEN; ULMUS AMERICANA POLLEN; ACER RUBRUM POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; JUNIPERUS VIRGINIANA POLLEN; CARYA ILLINOINENSIS POLLEN; FRAXINUS AMERICANA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN .000016; .0004; .0004; .0004; .00008; .00008; .000016; .0004; 20000; .0004; .002; .01; .0004; .0004; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0790_2fc9a4e3-a3ca-4795-91c7-95f1061f4ae0 49288-0790 HUMAN PRESCRIPTION DRUG Treatment Set TS336851 Treatment Set TS336851 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLADOSPORIUM HERBARUM; ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; QUERCUS ALBA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; IVA ANNUA VAR. ANNUA POLLEN 400; 400; .002; .002; .002; .002; 400; .002; .002; .002; 4000; .002; .002; .002 [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0791_2fc9a4e3-a3ca-4795-91c7-95f1061f4ae0 49288-0791 HUMAN PRESCRIPTION DRUG Treatment Set TS337026 Treatment Set TS337026 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PLEOSPORA HERBARUM; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN; CANDIDA ALBICANS .002; 80; .00067; .00067; .00067; .00067; .00067; .00067; .002; .002; .0004; .00008; .00004; .00004; .00008; .00008; .00008; .00002; .00002; .00002; .00002; .0004; .002; .002; .002; .002; .002; .002 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0792_d7b4b93b-b9fc-4188-a1ab-b905d286e2ee 49288-0792 HUMAN PRESCRIPTION DRUG Treatment Set TS337554 Treatment Set TS337554 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; QUERCUS ALBA POLLEN 2000; .01 [AU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0793_d7b4b93b-b9fc-4188-a1ab-b905d286e2ee 49288-0793 HUMAN PRESCRIPTION DRUG Treatment Set TS337681 Treatment Set TS337681 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; CLADOSPORIUM HERBARUM; ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; QUERCUS ALBA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; IVA ANNUA VAR. ANNUA POLLEN; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN 166.667; 166.667; .0008333; .0008333; .0008333; 33.333; .0000333; .0016666; 666.667; .0016666; .0016666; .0003333; .0016666; 333.333; 666.667; .0016666; .0016666; .0016666; .0003333; .0016666; .0016666; .0016666; .0016666; .0008333; .0008333 [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0794_d7b4b93b-b9fc-4188-a1ab-b905d286e2ee 49288-0794 HUMAN PRESCRIPTION DRUG Treatment Set TS338384 Treatment Set TS338384 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; POA PRATENSIS POLLEN; DERMATOPHAGOIDES FARINAE; CANIS LUPUS FAMILIARIS HAIR; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CANDIDA ALBICANS; JUNIPERUS VIRGINIANA POLLEN; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; RHIZOPUS STOLONIFER; ACER NEGUNDO POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; PLEOSPORA HERBARUM; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN 16; 4000; 400; .002; .0006666; .0006666; .0006666; .005; .002; .002; .002; .002; .005; .002; .002; .005; .005; .00008; .005 [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 49288-0795_dea14126-aacc-4f9f-81fe-9bf179310483 49288-0795 HUMAN PRESCRIPTION DRUG Treatment Set TS338618 Treatment Set TS338618 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; FRAXINUS AMERICANA POLLEN 2000; 2000; 20000; 10000; .05; .005 [BAU]/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0796_dea14126-aacc-4f9f-81fe-9bf179310483 49288-0796 HUMAN PRESCRIPTION DRUG Treatment Set TS338909 Treatment Set TS338909 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; FRAXINUS AMERICANA POLLEN; POA PRATENSIS POLLEN; ALTERNARIA ALTERNATA; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; BETULA NIGRA POLLEN; QUERCUS ALBA POLLEN; PLEOSPORA HERBARUM; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN 3.2; .000016; 32; .000016; .000016; .000016; .000016; .000016; .000016; .000016; .000016; .000008; .000008; .0000053; .0000053; .0000053; .000008; .000008 [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0797_dea14126-aacc-4f9f-81fe-9bf179310483 49288-0797 HUMAN PRESCRIPTION DRUG Treatment Set TS338910 Treatment Set TS338910 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CYNODON DACTYLON POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; PERIPLANETA AMERICANA; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN .00013; .00013; .00013; 80; .0001; .0001; .0001; .0001; .00008; .00008; .0004; .0004 g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0798_dea14126-aacc-4f9f-81fe-9bf179310483 49288-0798 HUMAN PRESCRIPTION DRUG Treatment Set TS339118 Treatment Set TS339118 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; ASPERGILLUS FUMIGATUS; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; PHOMA DESTRUCTIVA; PERIPLANETA AMERICANA; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .00008; 16; .002; 16; .002; .002; .00008; .00008; .00008; .00008; .01; .0005; .0005; .0005; .0005; .0000266; .0000266; .00000266 g/mL; [AU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 49288-0799_dea14126-aacc-4f9f-81fe-9bf179310483 49288-0799 HUMAN PRESCRIPTION DRUG Treatment Set TS339119 Treatment Set TS339119 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN .0004; .0004; .0000266; .0000266; .0000266; .002; 80; .002; .00008; .00008; .0004; .00008; .002; .01; .01; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0800_546445e5-abf0-45e0-99fc-859dccb66062 49288-0800 HUMAN PRESCRIPTION DRUG Treatment Set TS339184 Treatment Set TS339184 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; ASPERGILLUS FUMIGATUS; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; PLEOSPORA HERBARUM; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI 16; .00008; .00008; .0008; .00008; .0004; .0004; .00008; .00008; .00008; .00008; .00002; .00002; .00002; .00002 [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0801_546445e5-abf0-45e0-99fc-859dccb66062 49288-0801 HUMAN PRESCRIPTION DRUG Treatment Set TS339185 Treatment Set TS339185 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; BETULA NIGRA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN 160; .002; .00008; .00008; .00008; .00008; .00067; .00067; .00067; .00004; .00004; .0004; 400; .0004; .00008; .00008; .00008; .00008; .0004; .00008 [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0802_604c0704-1a4c-431a-9876-de77f5f3882c 49288-0802 HUMAN PRESCRIPTION DRUG Treatment Set TS339754 Treatment Set TS339754 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; POA PRATENSIS POLLEN; PASPALUM NOTATUM POLLEN; BETULA POPULIFOLIA POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PLANTAGO LANCEOLATA POLLEN; FESTUCA PRATENSIS POLLEN; CARYA ALBA POLLEN 16; 400; .002; 4000; .002; .002; .002; .002; 800; .002; 4000; .002 [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0803_604c0704-1a4c-431a-9876-de77f5f3882c 49288-0803 HUMAN PRESCRIPTION DRUG Treatment Set TS339813 Treatment Set TS339813 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; JUNIPERUS ASHEI POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN .002; 400; .002; .002; 4000; .002 g/mL; [BAU]/mL; g/mL; g/mL; [AU]/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0804_604c0704-1a4c-431a-9876-de77f5f3882c 49288-0804 HUMAN PRESCRIPTION DRUG Treatment Set TS339992 Treatment Set TS339992 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; CYNODON DACTYLON POLLEN; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ULMUS AMERICANA POLLEN; ACER NEGUNDO POLLEN 400; 400; 1000; .005; .002; 4000; 10000; .005; .005 [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0805_604c0704-1a4c-431a-9876-de77f5f3882c 49288-0805 HUMAN PRESCRIPTION DRUG Treatment Set TS340053 Treatment Set TS340053 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; ASPERGILLUS FUMIGATUS; CLADOSPORIUM CLADOSPORIOIDES; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER; CANDIDA ALBICANS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; COCHLIOBOLUS SATIVUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; PLEOSPORA HERBARUM; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER 16; 16; .00008; .002; .00008; 16; .00008; .002; .002; .00008; .00008; .002; .01; .00008; .002; .0005; .0005; .0005; .0005; .0002; .0002; .0006666; .0006666; .0006666 [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0806_604c0704-1a4c-431a-9876-de77f5f3882c 49288-0806 HUMAN PRESCRIPTION DRUG Treatment Set TS340054 Treatment Set TS340054 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; BETULA NIGRA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN 160; .00008; .002; .002; .002; .00008; .0000266; .0000266; .0000266; .001; .001; .0004; 16; .00008; .00008; .002; .002; .002; .0004; .00008; .0004 [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0807_ae8520ee-f4a4-4de4-9d2d-bccc97d30931 49288-0807 HUMAN PRESCRIPTION DRUG Treatment Set TS340074 Treatment Set TS340074 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CYNODON DACTYLON POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ALBA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; CANIS LUPUS FAMILIARIS HAIR; JUGLANS NIGRA POLLEN; ULMUS AMERICANA POLLEN; PHLEUM PRATENSE POLLEN; IVA ANNUA VAR. ANNUA POLLEN; CARYA TOMENTOSA POLLEN 400; 1000; 10000; .0025; 400; 400; .002; .005; .005; 4000; .005; .0025 [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0808_ae8520ee-f4a4-4de4-9d2d-bccc97d30931 49288-0808 HUMAN PRESCRIPTION DRUG Treatment Set TS340153 Treatment Set TS340153 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CARYA TOMENTOSA POLLEN; CARYA ILLINOINENSIS POLLEN; ULMUS AMERICANA POLLEN; SALSOLA KALI POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN .0002; .0002; .01; .01; .01; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0809_ae8520ee-f4a4-4de4-9d2d-bccc97d30931 49288-0809 HUMAN PRESCRIPTION DRUG Treatment Set TS340525 Treatment Set TS340525 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; RHIZOPUS STOLONIFER; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; ASPERGILLUS FUMIGATUS; CANDIDA ALBICANS; PERIPLANETA AMERICANA; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PLEOSPORA HERBARUM; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .00008; .00008; .00008; 16; 16; .002; .002; .00008; .002; .00008; .00008; .00008; .00002; .00002; .00002; .00002; .00067; .00067; .00067 g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient] E 20171231 49288-0810_ae8520ee-f4a4-4de4-9d2d-bccc97d30931 49288-0810 HUMAN PRESCRIPTION DRUG Treatment Set TS340526 Treatment Set TS340526 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; IVA ANNUA VAR. ANNUA POLLEN; ACER NEGUNDO POLLEN; POA PRATENSIS POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; CARYA TOMENTOSA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN 16; .002; .00008; 400; .002; .002; .00008; .00004; .0004; .00008; .00004; .0004; .002; .002; .002; .002; .00008; .00008; .00008 [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0811_2413d900-60a6-4cfd-99b2-0ceccd0d1249 49288-0811 HUMAN PRESCRIPTION DRUG Treatment Set TS340796 Treatment Set TS340796 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; PERIPLANETA AMERICANA; JUGLANS NIGRA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMARANTHUS RETROFLEXUS POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN 400; 400; .002; .002; 400; 4000; .002; .001; .001 [AU]/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0812_2413d900-60a6-4cfd-99b2-0ceccd0d1249 49288-0812 HUMAN PRESCRIPTION DRUG Treatment Set TS340826 Treatment Set TS340826 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA TRIFIDA POLLEN; HOUSE DUST; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; FRAXINUS AMERICANA POLLEN; POPULUS DELTOIDES POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; PLANTAGO LANCEOLATA POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN; IVA XANTHIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN .0012; .0024; .0012; .0024; 476.19; .0024; 4761.9; 4761.9; .0024; .0024; .0024; .0024; .0024; .0024; .0024; .0024; .0024; .0012; .0012; .0012; .0012; .0008; .0008; .0008; .0008; .0008; .0008; .0004; .0004; .0004; .0004; .0004; .0004 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] E 20171231 49288-0813_059e23cb-ae1d-4fe5-9496-93f48225effd 49288-0813 HUMAN PRESCRIPTION DRUG Treatment Set TS340987 Treatment Set TS340987 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR .002 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0814_059e23cb-ae1d-4fe5-9496-93f48225effd 49288-0814 HUMAN PRESCRIPTION DRUG Treatment Set TS341430 Treatment Set TS341430 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; SORGHUM HALEPENSE POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; ULMUS AMERICANA POLLEN; POPULUS DELTOIDES POLLEN; IVA ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; BASSIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; RHIZOPUS STOLONIFER; PHOMA DESTRUCTIVA; CANDIDA ALBICANS; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM .00008; .002; .002; .001; .001; .00008; .002; .002; .002; .002; .002; .002; 16; 16; 400; .002; .002; .00008; .002; .002; .0004; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0815_059e23cb-ae1d-4fe5-9496-93f48225effd 49288-0815 HUMAN PRESCRIPTION DRUG Treatment Set TS341451 Treatment Set TS341451 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; SPORISORIUM CRUENTUM; ULMUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; CARYA TOMENTOSA POLLEN; PLATANUS OCCIDENTALIS POLLEN; MORUS ALBA POLLEN; PLANTAGO LANCEOLATA POLLEN; SALSOLA KALI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; URTICA DIOICA POLLEN .002; 4000; 400; 400; 80; 32; .0004; .002; .002; .002; .002; .002; .002; .002; .002; .002; .002 g/mL; [AU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0817_059e23cb-ae1d-4fe5-9496-93f48225effd 49288-0817 HUMAN PRESCRIPTION DRUG Treatment Set TS341474 Treatment Set TS341474 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; CYNODON DACTYLON POLLEN; IVA ANNUA POLLEN; ACER NEGUNDO POLLEN; CANIS LUPUS FAMILIARIS HAIR; CANDIDA ALBICANS; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER; PERIPLANETA AMERICANA; JUNIPERUS VIRGINIANA POLLEN; ASPERGILLUS FUMIGATUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; PLEOSPORA HERBARUM; SORGHUM HALEPENSE POLLEN; AMARANTHUS RETROFLEXUS POLLEN; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI 400; 16; .002; .002; .002; .00008; .002; .002; .002; .00008; .002; .00008; .00008; .002; .00008; .002; .002; .002; .002; .002; .002; .0000266; .0000266; .0000266; .00004; .00004; .0005; .0005; .0005; .0005 [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0818_059e23cb-ae1d-4fe5-9496-93f48225effd 49288-0818 HUMAN PRESCRIPTION DRUG Treatment Set TS341824 Treatment Set TS341824 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. SORGHUM HALEPENSE POLLEN; LOLIUM PERENNE POLLEN; FRAXINUS AMERICANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; PLANTAGO LANCEOLATA POLLEN; BASSIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN .0029; 5882; .0029; .0029; .0029; .0029; .0029; .0029; .0029; .0029; .0029; .0029; .00145; .00145; .00145; .00145; .00097; .00097; .00097; .00097; .00097; .00097; .00048; .00048; .00048; .00048; .00048; .00048 g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0819_88d480d9-a016-4787-9db3-dcca62d0d1ca 49288-0819 NON-STANDARDIZED ALLERGENIC Treatment Set TS342034 Treatment Set TS342034 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR; PLANTAGO LANCEOLATA POLLEN .01; .01 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0820_88d480d9-a016-4787-9db3-dcca62d0d1ca 49288-0820 NON-STANDARDIZED ALLERGENIC Treatment Set TS342109 Treatment Set TS342109 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; QUERCUS ALBA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; CARYA TOMENTOSA POLLEN; RUMEX ACETOSELLA POLLEN; ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA; FELIS CATUS HAIR; JUNIPERUS ASHEI POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; PHLEUM PRATENSE POLLEN .002; .002; 4000; .001; .002; 400; .002; .002; .002; .002; .001; .002; .002; .002; 400; .002; .002; .002; 4000 g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0821_88d480d9-a016-4787-9db3-dcca62d0d1ca 49288-0821 NON-STANDARDIZED ALLERGENIC Treatment Set TS342155 Treatment Set TS342155 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; JUNIPERUS ASHEI POLLEN 80; .01; .01 [BAU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0822_88d480d9-a016-4787-9db3-dcca62d0d1ca 49288-0822 NON-STANDARDIZED ALLERGENIC Treatment Set TS342370 Treatment Set TS342370 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN 2000; .01; .002 [BAU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0823_da61c6b6-9055-4d5e-909c-eeb1bf0e016c 49288-0823 HUMAN PRESCRIPTION DRUG Treatment Set TS342922 Treatment Set TS342922 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; CYNODON DACTYLON POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ACER NEGUNDO POLLEN; FELIS CATUS HAIR; POA PRATENSIS POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; GALLUS GALLUS FEATHER; ANSER ANSER FEATHER; ANAS PLATYRHYNCHOS FEATHER; PLANTAGO LANCEOLATA POLLEN; CANDIDA ALBICANS; JUNIPERUS VIRGINIANA POLLEN; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; PLEOSPORA HERBARUM; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI 16; 400; 16; .0006666; .00008; 16; 4000; .002; .0006666; .0006666; .000027; .000027; .000027; .0004; .00008; .00008; .002; .00008; .002; .002; .002; .00008; .002; .002; .002; .002; .0005; .0005; .0005; .0005 [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0824_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0824 HUMAN PRESCRIPTION DRUG Treatment Set TS343825 Treatment Set TS343825 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .01; .01; .01; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0825_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0825 HUMAN PRESCRIPTION DRUG Treatment Set TS343826 Treatment Set TS343826 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. SORGHUM HALEPENSE POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ULMUS AMERICANA POLLEN; PLANTAGO LANCEOLATA POLLEN; FRAXINUS AMERICANA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; LOLIUM PERENNE POLLEN; PLATANUS OCCIDENTALIS POLLEN; ARTEMISIA VULGARIS POLLEN; IVA AXILLARIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN .003; .0015; .0015; .003; .003; .003; .003; .003; .003; .003; 6666.67; .003; .003; .003; .0015; .0015; .001; .001; .001 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0826_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0826 HUMAN PRESCRIPTION DRUG Treatment Set TS344001 Treatment Set TS344001 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; AMBROSIA ARTEMISIIFOLIA POLLEN; PLANTAGO LANCEOLATA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; FESTUCA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 1000; .005; 800; .0004; .005; 800; 1000; .005; .005; 800; .002; 80; 400 [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; [AU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0827_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0827 HUMAN PRESCRIPTION DRUG Treatment Set TS344002 Treatment Set TS344002 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ULMUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN 80; 800; 800; .0004; .0004; .0004; .0004; .0004; .0004; .0004; 800; .0004; .0004; .0004; .0004; .0004; .0004; .0004; .0004; .0002; .0002 [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0828_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0828 HUMAN PRESCRIPTION DRUG Treatment Set TS344003 Treatment Set TS344003 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; ASPERGILLUS FUMIGATUS; COCHLIOBOLUS SATIVUS; CLADOSPORIUM HERBARUM; FUSARIUM OXYSPORUM 400; 400; .0004; .002; 80; .002; .002; .002; .0004 [BAU]/mL; [AU]/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0829_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0829 HUMAN PRESCRIPTION DRUG Treatment Set TS344004 Treatment Set TS344004 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN 800; 400; .0002; .0002; .002; .002; .002; .002; .002; 4000; .002; .002; 800; .002; .002; .002; .002; .002; .002; .002; .002 [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0830_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc 49288-0830 HUMAN PRESCRIPTION DRUG Treatment Set TS344005 Treatment Set TS344005 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; EQUUS CABALLUS HAIR 80; .002; .005; 400; 400; .002; .002; .005; .005; .005; .0004 [BAU]/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0831_f38e0c9c-da50-41d7-a0c6-506be87d4981 49288-0831 HUMAN PRESCRIPTION DRUG Treatment Set TS344059 Treatment Set TS344059 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; AMBROSIA ARTEMISIIFOLIA POLLEN; ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA 2000; 20000; .01; .01 [BAU]/mL; [AU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0832_f38e0c9c-da50-41d7-a0c6-506be87d4981 49288-0832 HUMAN PRESCRIPTION DRUG Treatment Set TS344419 Treatment Set TS344419 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; CHENOPODIUM ALBUM POLLEN; CARYA TOMENTOSA POLLEN; URTICA DIOICA POLLEN; RUMEX ACETOSELLA POLLEN; FESTUCA PRATENSIS POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; BETULA POPULIFOLIA POLLEN .002; .00008; .00008; .00008; 160; .00004; .00008; 16; .00008; .00008; .00008; .002; .00008; .00004; .00008; .00008; 160; .00008; 160; .00008; .00008 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0833_f38e0c9c-da50-41d7-a0c6-506be87d4981 49288-0833 HUMAN PRESCRIPTION DRUG Treatment Set TS344420 Treatment Set TS344420 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PERIPLANETA AMERICANA; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS .002; 400; 400; .002; .00008 g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0834_f38e0c9c-da50-41d7-a0c6-506be87d4981 49288-0834 HUMAN PRESCRIPTION DRUG Treatment Set TS344421 Treatment Set TS344421 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ULMUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; RUMEX ACETOSELLA POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN 16; 400; 160; .00008; .002; .00008; .00008; .00008; .00008; 400; .002; .002; .002; .00008; .01; .00008; .00008; .00004; .00004 [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0835_f38e0c9c-da50-41d7-a0c6-506be87d4981 49288-0835 HUMAN PRESCRIPTION DRUG Treatment Set TS344422 Treatment Set TS344422 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; COCHLIOBOLUS SATIVUS; CLADOSPORIUM HERBARUM 2000; 400; .002; .01; 400; .002; .002 [BAU]/mL; [AU]/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0836_3d2e8502-9a04-4060-a553-26e1bf285501 49288-0836 HUMAN PRESCRIPTION DRUG Treatment Set TS344558 Treatment Set TS344558 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES; ASPERGILLUS FUMIGATUS; COCHLIOBOLUS SATIVUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; FUSARIUM OXYSPORUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN .00008; .00004; .005; .005; .005; .002; .005; .002; .005; .005 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0837_3d2e8502-9a04-4060-a553-26e1bf285501 49288-0837 HUMAN PRESCRIPTION DRUG Treatment Set TS344570 Treatment Set TS344570 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; DERMATOPHAGOIDES PTERONYSSINUS; AMBROSIA ARTEMISIIFOLIA POLLEN; SORGHUM HALEPENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN 400; 400; .01; 400; 4000; .002; .01; .01; .01 [BAU]/mL; [AU]/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0838_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0838 HUMAN PRESCRIPTION DRUG Treatment Set TS344592 Treatment Set TS344592 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; CANIS LUPUS FAMILIARIS HAIR 2000; .002 [AU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0839_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0839 HUMAN PRESCRIPTION DRUG Treatment Set TS344801 Treatment Set TS344801 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; IVA ANNUA VAR. ANNUA POLLEN; CARYA TOMENTOSA POLLEN; JUGLANS NIGRA POLLEN; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR .002; 4000; .001; .002; .001; .002; .002; 400 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] E 20171231 49288-0840_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0840 HUMAN PRESCRIPTION DRUG Treatment Set TS345048 Treatment Set TS345048 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; AMBROSIA ARTEMISIIFOLIA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 2000; .01; 20000; 2000; 2000 [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; [AU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0841_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0841 HUMAN PRESCRIPTION DRUG Treatment Set TS345049 Treatment Set TS345049 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; POA PRATENSIS POLLEN; PLANTAGO LANCEOLATA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; CARYA TOMENTOSA POLLEN; CARYA ILLINOINENSIS POLLEN 16; .002; .00067; .002; .00067; .00067; 4000; .002; .00008; .00008; .00008; .002; .002; .001; .001 [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0842_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0842 HUMAN PRESCRIPTION DRUG Treatment Set TS345050 Treatment Set TS345050 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; ASPERGILLUS FUMIGATUS; PHOMA DESTRUCTIVA; RHIZOPUS STOLONIFER; CANDIDA ALBICANS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; COCHLIOBOLUS SATIVUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; PLEOSPORA HERBARUM; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER 400; .002; .00008; .00008; .002; .00008; .002; .002; .0008; .00008; .002; .002; .001; .001; .00003; .00003; .00003 [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 49288-0843_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0843 HUMAN PRESCRIPTION DRUG Treatment Set TS345268 Treatment Set TS345268 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN 20000; .01 [AU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0844_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0844 HUMAN PRESCRIPTION DRUG Treatment Set TS345302 Treatment Set TS345302 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ASPERGILLUS FUMIGATUS; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PHOMA DESTRUCTIVA; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PLEOSPORA HERBARUM; GALLUS GALLUS FEATHER; ANSER ANSER FEATHER; ANAS PLATYRHYNCHOS FEATHER; USTILAGO AVENAE; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO TRITICI; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM 80; 400; .00008; .0004; .0004; .002; .0004; .00008; .00067; .00067; .00067; .0005; .0005; .0005; .0005; .001; .001 [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0845_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0845 HUMAN PRESCRIPTION DRUG Treatment Set TS345303 Treatment Set TS345303 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; ULMUS AMERICANA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA PSILOSTACHYA POLLEN 160; .00008; 16; .0004; .002; .00008; .00008; .00008; .00008; .00008; .00008; .002; .0004; .002; .0004; .00004; .00004; .00013; .00013; .00013 [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0846_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0846 HUMAN PRESCRIPTION DRUG Treatment Set TS345380 Treatment Set TS345380 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS WHOLE; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; SORGHUM HALEPENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN 400; .002; .002; .002; 160; .004; .0004; .002; .0004; .01; .002; .002; .0004; .002 [BAU]/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0847_9a8e59e8-156a-4999-a000-b68054b405d3 49288-0847 HUMAN PRESCRIPTION DRUG Treatment Set TS345381 Treatment Set TS345381 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM .0004; 80; .0004; 16; 16; .01; .0004 g/mL; [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0848_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0848 HUMAN PRESCRIPTION DRUG Treatment Set TS345463 Treatment Set TS345463 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA 16; .001; .001; .002; 160; .0004; .002; 160; .0004; .002 [BAU]/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0849_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0849 HUMAN PRESCRIPTION DRUG Treatment Set TS345476 Treatment Set TS345476 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; CARYA TOMENTOSA POLLEN; DERMATOPHAGOIDES FARINAE; FELIS CATUS HAIR; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; ALTERNARIA ALTERNATA; PLEOSPORA HERBARUM; ARTEMISIA ABSINTHIUM POLLEN; RUMEX ACETOSELLA POLLEN 4000; 1000; .005; 1000; 400; .005; .002; .005; .005; .005 g/mL; [BAU]/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0850_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0850 HUMAN PRESCRIPTION DRUG Treatment Set TS345694 Treatment Set TS345694 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; AMBROSIA ARTEMISIIFOLIA POLLEN; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; CARYA TOMENTOSA POLLEN; CARYA ILLINOINENSIS POLLEN; RUMEX ACETOSELLA POLLEN; PHLEUM PRATENSE POLLEN; FRAXINUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; EQUUS CABALLUS HAIR .002; 80; .002; 800; 80; 80; 400; 4000; .0002; .0002; .002; 4000; .002; .002; .002; .0004; .00008 g/mL; [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0851_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0851 HUMAN PRESCRIPTION DRUG Treatment Set TS345784 Treatment Set TS345784 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ACER NEGUNDO POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PASCOPYRUM SMITHII POLLEN; CARYA TOMENTOSA POLLEN; CARYA ILLINOINENSIS POLLEN; FELIS CATUS HAIR; PERIPLANETA AMERICANA 400; 400; 160; 800; .0004; 800; .002; .0004; .002; .0002; .0002; 400; .00008 [AU]/mL; [AU]/mL; [BAU]/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0852_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0852 HUMAN PRESCRIPTION DRUG Treatment Set TS345825 Treatment Set TS345825 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; CARYA TOMENTOSA POLLEN; PLATANUS OCCIDENTALIS POLLEN; MORUS ALBA POLLEN; JUNIPERUS ASHEI POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PLANTAGO LANCEOLATA POLLEN; SALSOLA KALI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; URTICA DIOICA POLLEN 400; 16; 160; .00008; .00008; .0004; .0004; .0004; .0004; .0004; .002; 160; .0004; .0004; .0004; .002; .002 [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0853_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0853 HUMAN PRESCRIPTION DRUG Treatment Set TS345883 Treatment Set TS345883 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. URTICA DIOICA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; EQUUS CABALLUS HAIR; CARYA TOMENTOSA POLLEN; CARYA ILLINOINENSIS POLLEN; FELIS CATUS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; PERIPLANETA AMERICANA; ALTERNARIA ALTERNATA .0004; .0004; .002; 4000; .00008; 800; .002; .00008; .002; .00008; .0004; .00008; .0004; .00008; .01; .00004; .00004; 400; 16; .0004; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE] E 20171231 49288-0854_bfb6bdbb-da65-4cb3-a50d-250270cdd448 49288-0854 HUMAN PRESCRIPTION DRUG Treatment Set TS346157 Treatment Set TS346157 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; IVA ANNUA POLLEN 1000; 1000; .005; 1000; 4000; 4000; .005 [AU]/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; [AU]/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0855_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0855 NON-STANDARDIZED ALLERGENIC Treatment Set TS346618 Treatment Set TS346618 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. BETULA POPULIFOLIA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PLANTAGO LANCEOLATA POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; PERIPLANETA AMERICANA; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; PASCOPYRUM SMITHII POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS .002; 4000; .002; .002; .002; .002; .002; .002; .002; .002; .002; .002; .002; 400; .002; .002 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0856_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0856 NON-STANDARDIZED ALLERGENIC Treatment Set TS346619 Treatment Set TS346619 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; SORGHUM HALEPENSE POLLEN; CARYA ILLINOINENSIS POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; FRAXINUS AMERICANA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; CARYA TOMENTOSA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN .002; .002; .00008; .00004; 16; .002; .0004; .00008; .00004; 160; 800; .0004; 160; .0004 g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0857_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0857 NON-STANDARDIZED ALLERGENIC Treatment Set TS346620 Treatment Set TS346620 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ALTERNARIA ALTERNATA; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; COCHLIOBOLUS SATIVUS; PERIPLANETA AMERICANA .002; 80; .002; 80; 80; .01; .01 g/mL; [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0858_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0858 NON-STANDARDIZED ALLERGENIC Treatment Set TS346697 Treatment Set TS346697 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; ULMUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; MORUS RUBRA POLLEN; CARYA TOMENTOSA POLLEN; CARYA ILLINOINENSIS POLLEN 400; 10000; .005; .005; .005; .005; .0004; .00008; .002; .005; .00008; .002; .001; .001 [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0859_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0859 NON-STANDARDIZED ALLERGENIC Treatment Set TS346698 Treatment Set TS346698 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PHLEUM PRATENSE POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN .002; 800; 4000; .00008; .002 g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0860_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0860 NON-STANDARDIZED ALLERGENIC Treatment Set TS346752 Treatment Set TS346752 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA TOMENTOSA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; .002; .002; 4000; .002; 400; .002; .002; 4000; .002; .002; .00008; .002; .0004; .0004; .002; .002; .00008; .00004; .00004; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0861_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0861 NON-STANDARDIZED ALLERGENIC Treatment Set TS346790 Treatment Set TS346790 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; CARYA TOMENTOSA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN .002; .002; 4000; .002; 400; 160; .0004; .002; 160; .00008; .002; .002; .0004; .002; .001; .001; .002 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0862_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0862 NON-STANDARDIZED ALLERGENIC Treatment Set TS346791 Treatment Set TS346791 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS 400; .01; .01; .0004; .01 [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0863_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0863 NON-STANDARDIZED ALLERGENIC Treatment Set TS346876 Treatment Set TS346876 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; SALIX NIGRA POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN .002; .0004; .0004; .00008; 160; .005; .00008; .005; .002; .005; .0004; .0004; .002; .00004; .0004; .00008; .0004; .002; .001; .001 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0864_fdad2abe-8504-4d78-9599-5e850d792dc8 49288-0864 NON-STANDARDIZED ALLERGENIC Treatment Set TS346877 Treatment Set TS346877 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS 16; 10000; .0004; .0004; 160; .0004; 16; .005; .005; .005; .005 [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0865_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0865 NON-STANDARDIZED ALLERGENIC Treatment Set TS346889 Treatment Set TS346889 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; PERIPLANETA AMERICANA; ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM; FRAXINUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; MORUS RUBRA POLLEN .002; .002; .002; 4000; 16; 160; .0004; .00008; 800; .0004; 400; .002; .002; .002; .002; .002; .002; .002; .002; .00004; .00004; .002 g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] E 20171231 49288-0866_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0866 NON-STANDARDIZED ALLERGENIC Treatment Set TS346962 Treatment Set TS346962 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; .002; .0004; 160; .0004; .0004; .002; .0004; .002; .002; .002; .002; .00004; .00004; .001; .001; .00008; .002; .002; .0004 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0867_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0867 NON-STANDARDIZED ALLERGENIC Treatment Set TS346963 Treatment Set TS346963 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN 400; .002; .002; 80; 400; .002; .002; .002; .002; .002; 16; 4000; .002; .002; 800; .0004 [BAU]/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0868_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0868 NON-STANDARDIZED ALLERGENIC Treatment Set TS346964 Treatment Set TS346964 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; URTICA DIOICA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; FRAXINUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; 4000; .002; 400; 4000; .002; .00008; 4000; .0004; 400; .002; .002; .002; .002; .0002; .0002; .002; .0004 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0869_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0869 NON-STANDARDIZED ALLERGENIC Treatment Set TS347115 Treatment Set TS347115 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; BETULA NIGRA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN .002; .0004; .0004; .00008; 4000; .0004; 16; 4000; .002; .002; 800; .002; .00008; .0004; .0004; .00008; .00008; .00008; .0004; .00004; .00004; .0004; .0002; .0002; .0004; .0004 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0870_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0870 NON-STANDARDIZED ALLERGENIC Treatment Set TS347116 Treatment Set TS347116 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS; MORUS RUBRA POLLEN 80; .002; 400; 2000; .01; .002; .0004 [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0871_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0871 NON-STANDARDIZED ALLERGENIC Treatment Set TS347226 Treatment Set TS347226 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; JUGLANS NIGRA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN .002; .002; .002; .002; .002; 80; 160; .00008; .00008; 160; .00008; 80; .002; .00004; .00004; .002; .001; .001; .0004; .00067; .00067; .00067 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0872_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0872 NON-STANDARDIZED ALLERGENIC Treatment Set TS347227 Treatment Set TS347227 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; COCHLIOBOLUS SATIVUS; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN 400; 4000; .0004; 800; .002; 400; .002; .002; .002; .002; .0004; .002; .0004; .00004; .00004; .001; .001; .002; .002; .00013; .00013; .00013 [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0873_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0873 NON-STANDARDIZED ALLERGENIC Treatment Set TS347249 Treatment Set TS347249 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; FRAXINUS AMERICANA POLLEN; POPULUS DELTOIDES POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; MORUS RUBRA POLLEN .002; .002; .002; 4000; .002; 80; 800; .002; .002; 800; .002; 400; 400; 400; .002; .002; .002; .002; .002; .001; .001; .002; .0004 g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0874_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0874 NON-STANDARDIZED ALLERGENIC Treatment Set TS347250 Treatment Set TS347250 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FESTUCA PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN 20000; 4000; .01; .0004; .0004; .0002; .0002 [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0875_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0875 NON-STANDARDIZED ALLERGENIC Treatment Set TS347335 Treatment Set TS347335 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA; POPULUS DELTOIDES POLLEN; COCHLIOBOLUS SATIVUS; ULMUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; MORUS RUBRA POLLEN; EQUUS CABALLUS HAIR 1000; 4000; .005; 4000; .002; 80; .002; .002; .002; .00008; .005; .002; .005; .002 [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0876_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0876 NON-STANDARDIZED ALLERGENIC Treatment Set TS347336 Treatment Set TS347336 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .0004; .002; .0004; 4000; .0004; .0004; .0004; .00008; .00008; .0004; .00008; .00004; .00004; .0004; .002; .0004; .00008 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0877_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0877 NON-STANDARDIZED ALLERGENIC Treatment Set TS347337 Treatment Set TS347337 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PASCOPYRUM SMITHII POLLEN; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA 80; 20000; .00008; .01; .002; .002; 2000; .002 [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0878_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0878 NON-STANDARDIZED ALLERGENIC Treatment Set TS347338 Treatment Set TS347338 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; FELIS CATUS HAIR; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS; FRAXINUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN; MORUS RUBRA POLLEN .002; 800; 400; .002; .002; 800; 400; .002; .002; .0004; .002; .002; .002; .002; .0002; .0002; .002; .002; .002 g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0879_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0879 NON-STANDARDIZED ALLERGENIC Treatment Set TS347483 Treatment Set TS347483 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; URTICA DIOICA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; ALTERNARIA ALTERNATA; BETULA NIGRA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN .005; .005; 10000; 400; .002; .0004; 4000; .002; .005; .002; .001; .001 g/mL; g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0880_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0880 NON-STANDARDIZED ALLERGENIC Treatment Set TS347484 Treatment Set TS347484 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; FRAXINUS AMERICANA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; EQUUS CABALLUS HAIR .002; .002; .005; 400; .002; .005; .005; .005; .001; .001; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0881_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0881 NON-STANDARDIZED ALLERGENIC Treatment Set TS347536 Treatment Set TS347536 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN .01; .002; .002; 4000; .01; 2000; .002; .002; .002; .001; .001; .002 g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0882_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0882 NON-STANDARDIZED ALLERGENIC Treatment Set TS347537 Treatment Set TS347537 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; FRAXINUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; .002; .0004; .002; 4000; 400; .002; .002; .002; .0004; .002; .002; .0002; .0002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0883_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0883 NON-STANDARDIZED ALLERGENIC Treatment Set TS347627 Treatment Set TS347627 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; EQUUS CABALLUS HAIR; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; ORYCTOLAGUS CUNICULUS HAIR; BOS TAURUS HAIR; ODOCOILEUS VIRGINIANUS HAIR 400; .002; .002; 400; .002; .005; .002; .00008; .00067; .00067; .0067; .005; .005; .005 [BAU]/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] E 20171231 49288-0884_f6f33373-7c0b-4834-add6-a7c79d24e403 49288-0884 NON-STANDARDIZED ALLERGENIC Treatment Set TS347628 Treatment Set TS347628 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; .002; 4000; 16; 160; .0004; .00008; 160; .00008; .00008; .00008; .002; .002; .002; .002; .00008; .0002; .0002; .002; .004; .004; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] E 20171231 49288-0885_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0885 NON-STANDARDIZED ALLERGENIC Treamtent Set TS347738 Treamtent Set TS347738 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS; FRAXINUS AMERICANA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; 4000; 80; 160; .002; 400; .002; .00008; .002; .002; .002; .001; .001; .002; .001; .001; .002; .002 g/mL; g/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0886_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0886 NON-STANDARDIZED ALLERGENIC Treatment Set TS347745 Treatment Set TS347745 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; MORUS RUBRA POLLEN .002; .002; .002; .0004; 160; .0004; .002; .002; .002; .0004; .002; .002; .001; .001; .002; .002 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0887_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0887 NON-STANDARDIZED ALLERGENIC Treatment Set TS347746 Treatment Set TS347746 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM 16; 800; .002; .0004; 160; .0004; 400; .002; .002; .0004; .002; .002 [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0888_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0888 NON-STANDARDIZED ALLERGENIC Treatment Set TS348237 Treatment Set TS348237 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR .005; 10000; .005; 10000; .005; 400; .002 g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0889_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0889 NON-STANDARDIZED ALLERGENIC Treatment Set TS348283 Treatment Set TS348283 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; ALTERNARIA ALTERNATA; QUERCUS ALBA POLLEN; ACER NEGUNDO POLLEN; PLATANUS OCCIDENTALIS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PLANTAGO LANCEOLATA POLLEN; RUMEX ACETOSELLA POLLEN; POA PRATENSIS POLLEN 400; .002; 400; .002; .002; .002; .002; .002; 4000; .002; .002; 4000 [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0890_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0890 NON-STANDARDIZED ALLERGENIC Treatment Set TS348334 Treatment Set TS348334 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; .002; .002; 4000; .002; 80; 4000; .002; .002; 4000; .002; .0004; .002; .002; .002; .0004; .002; .0004; .001; .001; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0891_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0891 NON-STANDARDIZED ALLERGENIC Treatment Set TS348335 Treatment Set TS348335 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PERIPLANETA AMERICANA; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS .002; .002; .01; .01; .01; .01 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0892_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0892 NON-STANDARDIZED ALLERGENIC Treatment Set TS348402 Treatment Set TS348402 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; 4000; .002; 400; 4000; .0004; .0004; 800; .002; .002; .002; .0004; .002; .002; .002; .0002; .0002; .0004; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0893_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0893 NON-STANDARDIZED ALLERGENIC Treatment Set TS348403 Treatment Set TS348403 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS 400; .01; .002; .002 [BAU]/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0894_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0894 NON-STANDARDIZED ALLERGENIC Treatment Set TS348404 Treatment Set TS348404 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .0004; .002; .00008; 4000; .002; .0004; .002; .002; .002; .002; .002; .00004; .00004; .002; .0002; .0002; .002; .00008; .002 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0895_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0895 NON-STANDARDIZED ALLERGENIC Treatment Set TS348405 Treatment Set TS348405 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PERIPLANETA AMERICANA; ALTERNARIA ALTERNATA 80; 20000; .0004; .002; 20000; .01; .00008 [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0896_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0896 NON-STANDARDIZED ALLERGENIC Treatment Set TS348467 Treatment Set TS348467 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; MUCOR RACEMOSUS; ALTERNARIA ALTERNATA; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; PLATANUS OCCIDENTALIS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PLANTAGO LANCEOLATA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX ACETOSELLA POLLEN; URTICA DIOICA POLLEN; POA PRATENSIS POLLEN; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PLEOSPORA HERBARUM; CARYA TOMENTOSA POLLEN; MORUS ALBA POLLEN; JUNIPERUS ASHEI POLLEN; SALSOLA KALI POLLEN 400; 400; .002; .002; .002; .002; .0004; .002; .002; .002; .002; 160; .002; .002; .002; .002; 800; .002; .0004; .0004; .002; .002; .002 [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0897_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0897 NON-STANDARDIZED ALLERGENIC Treatment Set TS348490 Treatment Set TS348490 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20121116 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; .002; .002; 800; .0004; .002; .002; .002; .002; .002; .002; .00004; .00004; .002; .001; .001; .002; .002 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0898_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0898 NON-STANDARDIZED ALLERGENIC Treatment Set TS348491 Treatment Set TS348491 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 20121116 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS 16; 800; .00008; .0004; 800; .002; 400; .01; 400; 400; .002; .01 [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0899_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0899 NON-STANDARDIZED ALLERGENIC Treatment Set TS348560 Treatment Set TS348560 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM ALBUM POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN; POPULUS DELTOIDES POLLEN; BOS TAURUS HAIR; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; ASPERGILLUS FUMIGATUS; ACER NEGUNDO POLLEN; JUGLANS NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; IVA ANNUA VAR. ANNUA POLLEN .002; .002; .002; .002; .002; .002; .002; .002; .002; 80; 80; .002; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0900_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0900 NON-STANDARDIZED ALLERGENIC Treatment Set TS348562 Treatment Set TS348562 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. ACER NEGUNDO POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; SORGHUM HALEPENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; RUMEX ACETOSELLA POLLEN; PERIPLANETA AMERICANA; CLADOSPORIUM HERBARUM; ASPERGILLUS FUMIGATUS; ALTERNARIA ALTERNATA; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS .002; .002; .002; .002; .002; .002; .002; 4000; .002; .002; 4000; 4000; .002; .002; .002; .002; .002; .002; .0004; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0901_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0901 NON-STANDARDIZED ALLERGENIC Treatment Set TS348563 Treatment Set TS348563 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. SORGHUM HALEPENSE POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; POA PRATENSIS POLLEN; FESTUCA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ALNUS RHOMBIFOLIA POLLEN; JUNIPERUS ASHEI POLLEN; POPULUS DELTOIDES POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; MORUS ALBA POLLEN; BOS TAURUS HAIR; COCHLIOBOLUS SATIVUS; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; ACER NEGUNDO POLLEN; JUGLANS NIGRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN .002; .002; .002; .002; .002; .002; 571.43; 571.43; 571.43; 571.43; 571.43; 571.43; 571.43; .002; .002; .002; .001; .001; .002; .002; .002; .002; 16; 16; .002; .002; .002; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient] E 20171231 49288-0902_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0902 NON-STANDARDIZED ALLERGENIC Treatment Set TS348650 Treatment Set TS348650 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; DERMATOPHAGOIDES PTERONYSSINUS; CANDIDA ALBICANS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; RHIZOPUS STOLONIFER; PLEOSPORA HERBARUM; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM 400; 16; .00008; .00008; .0004; .00003; .00003; .00003; 400; .002; .002; .002; .002; .002; .002; .002; .001; .001 [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0903_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0903 NON-STANDARDIZED ALLERGENIC Treatment Set TS348651 Treatment Set TS348651 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; QUERCUS ALBA POLLEN; POA PRATENSIS POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; POPULUS DELTOIDES POLLEN; FRAXINUS AMERICANA POLLEN; BETULA NIGRA POLLEN; KOCHIA SCOPARIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN 16; .002; .00008; .001; .001; .002; 4000; .000027; .000027; .000027; .002; .002; .002; .002; .00008 [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0904_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0904 NON-STANDARDIZED ALLERGENIC Treatment Set TS348982 Treatment Set TS348982 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; FRAXINUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN 400; .002; .002; .002; .002; .002; .002; .002; .0004; .002; .0002; .0002; .002; .001; .001; .002; .002; .002 [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0905_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0905 NON-STANDARDIZED ALLERGENIC Treatment Set TS349185 Treatment Set TS349185 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; 4000; .002; .002; .002; .002; .002; .002; .002; .002; .001; .001; .002; .001; .001; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0906_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0906 NON-STANDARDIZED ALLERGENIC Treatment Set TS349186 Treatment Set TS349186 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS; ANSER ANSER FEATHER; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER 80; .002; .002; 4000; .002; 400; .002; .002; 400; .002; .002; .002; .002; .00067; .00067; .00067 [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] E 20171231 49288-0907_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0907 NON-STANDARDIZED ALLERGENIC Treatment Set TS349163 Treatment Set TS349163 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FRAXINUS AMERICANA POLLEN; BETULA NIGRA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .005; .005; .002; .002; .005; .005; .00004; .00004; .005; .0025; .0025; .005; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0908_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0908 NON-STANDARDIZED ALLERGENIC Treatment Set TS349162 Treatment Set TS349162 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA .0004; .002; .002; .002; 20000; .01; 400; .002; 800; .002; 2000; .002; .0004 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0909_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0909 NON-STANDARDIZED ALLERGENIC Treatment Set TS349274 Treatment Set TS349274 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; EQUUS CABALLUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; BOS TAURUS HAIR; ODOCOILEUS VIRGINIANUS HAIR .002; 2000; .002; .00008; .01; .002; .01 g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] E 20171231 49288-0910_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0910 NON-STANDARDIZED ALLERGENIC Treatment Set TS349290 Treatment Set TS349290 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .00008; 160; .002; .002; .002; .002; .0004; .002; .002; .002; .00004; .00004; .002; .001; .001; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0911_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0911 NON-STANDARDIZED ALLERGENIC Treatment Set TS349291 Treatment Set TS349291 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS 400; 10000; .002; .002; 4000; .005; 400; .005; 1000; .00008; .005 [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0912_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0912 NON-STANDARDIZED ALLERGENIC Treatment Set TS349357 Treatment Set TS349357 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; ALTERNARIA ALTERNATA; PLATANUS OCCIDENTALIS POLLEN .002; 4000; .002; .01 g/mL; [BAU]/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0913_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0913 NON-STANDARDIZED ALLERGENIC Treatment Set TS349358 Treatment Set TS349358 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS; JUNIPERUS VIRGINIANA POLLEN .005; .002; 800; .002; 1000; 4000; .002; .0004; 800; .002; 400; .005; 1000; .002; .005; .0004 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0914_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0914 NON-STANDARDIZED ALLERGENIC Treatment Set TS349573 Treatment Set TS349573 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; 4000; .002; 16; 160; .00008; .00008; 160; .00008; 400; 400; .002; .002; .00004; .00004; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0915_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0915 NON-STANDARDIZED ALLERGENIC Treatment Set TS349574 Treatment Set TS349574 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; 4000; .002; .002; .002; .002; .002; .002; .00008; .00004; .00004; .002; .005; .005; .002; .0004; .002 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0916_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0916 NON-STANDARDIZED ALLERGENIC Treatment Set TS349575 Treatment Set TS349575 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; CLADOSPORIUM HERBARUM; COCHLIOBOLUS SATIVUS 400; .00008; 160; .002; 400; .005; 1000; .0004; .005; .005; .002 [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0917_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0917 NON-STANDARDIZED ALLERGENIC Treatment Set TS349576 Treatment Set TS349576 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; COCHLIOBOLUS SATIVUS; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .00008; 160; .002; 1000; .002; .005; .005; .005; .001; .001; .005; .005 g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0918_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0918 NON-STANDARDIZED ALLERGENIC Treatment Set TS349577 Treatment Set TS349577 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA; JUNIPERUS VIRGINIANA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; EQUUS CABALLUS HAIR .005; 160; 4000; 10000; .002; 400; .005; .005; .00008; .0002; .0002; .00008 g/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0919_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0919 NON-STANDARDIZED ALLERGENIC Treatment Set TS349631 Treatment Set TS349631 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .0004; .002; .0004; .00008; 160; .002; .00008; .00008; .00008; .00008; .0004; .0004; .00008; .00004; .00004; .0004; .001; .001; .0004; .00008; .00008 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0920_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0920 NON-STANDARDIZED ALLERGENIC Treatment Set TS349632 Treatment Set TS349632 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN 80; 160; .00008; .00008; 160; .0004 [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0921_c3d917bc-fa5c-42d8-aef9-5973a92fcb55 49288-0921 NON-STANDARDIZED ALLERGENIC Treatment Set TS349705 Treatment Set TS349705 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FESTUCA PRATENSIS POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; ALTERNARIA ALTERNATA; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; 800; .002; 800; .002; 160; .002; 400; .002; .002; .002; .002; .002; .002; .002; .002; .001; .001; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0922_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0922 NON-STANDARDIZED ALLERGENIC Treatment Set TS349778 Treatment Set TS349778 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .00008; .0004; .002; .00008; 160; .00008; .00008; .002; .0004; .0004; .0004; .002; .002; .00004; .00004; .00008; .001; .001; .002; .0004; .00008 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0923_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0923 NON-STANDARDIZED ALLERGENIC Treatment Set TS349779 Treatment Set TS349779 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 16; 160; .00008; .0004; 160; .0004; 400; .002; 16; 16 [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; [AU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0924_e266b12c-c311-4e1b-9d5a-1f448a15eb0e 49288-0924 NON-STANDARDIZED ALLERGENIC Treatment Set TS349815 Treatment Set TS349815 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES FARINAE; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; ASPERGILLUS FUMIGATUS 2000; .01; .01 [AU]/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0925_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0925 NON-STANDARDIZED ALLERGENIC Treatment Set TS349930 Treatment Set TS349930 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; MORUS RUBRA POLLEN .002; .002; .002; .0004; 4000; 16; 4000; .002; .0004; 160; .002; .002; .002; .0004; .0004; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0926_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0926 NON-STANDARDIZED ALLERGENIC Treatment Set TS349931 Treatment Set TS349931 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN 20000; .01; 400; 800; .00008; .00008; 160; .00008; .0004; .005; .005 [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0927_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0927 NON-STANDARDIZED ALLERGENIC Treatment Set TS349945 Treatment Set TS349945 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; EQUUS CABALLUS HAIR 400; 4000; .002; .002; 4000; .002; 400; .002; .002; 400; .002; .002; .002; .002; .002; .001; .001; .002; .002; .002; .00008 [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC] E 20171231 49288-0928_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0928 NON-STANDARDIZED ALLERGENIC Treatment Set TS350093 Treatment Set TS350093 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .0004; .002; .00008; 160; .00008; 16; .0004; .0004; 4000; .002; .00008; .0004; .0004; .0004; .00008; .0004; .0004; .00004; .00004; .002; .001; .001; .0004; .0004; .0004 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0929_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0929 NON-STANDARDIZED ALLERGENIC Treatment Set TS350094 Treatment Set TS350094 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS 16; .002; 16; 80; .00008; .01 [BAU]/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0930_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0930 NON-STANDARDIZED ALLERGENIC Treatment Set TS350242 Treatment Set TS350242 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PERIPLANETA AMERICANA; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR; ULMUS AMERICANA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; FRAXINUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; POA PRATENSIS POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; KOCHIA SCOPARIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN; CANDIDA ALBICANS; COCHLIOBOLUS SATIVUS; RHIZOPUS STOLONIFER; PLEOSPORA HERBARUM; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM .002; 16; 16; .00067; .00067; .00067; .0004; 80; .0004; .000027; .000027; .000027; 400; .002; .0004; .00008; .00008; .00004; .00004; 160; .002; .002; .002; .002; .002; .002; .002; .002; .001; .001 g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0931_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0931 NON-STANDARDIZED ALLERGENIC Treatment Set TS350256 Treatment Set TS350256 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; RUMEX ACETOSELLA POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; MORUS RUBRA POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN .0004; .00004; .00004; .002; .001; .001; .0004; .002; .00008; .0004; .0004; 4000; .0004; .00008; .0004; .0004; .00008; .0004; .00008; .002; .00008 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0932_01ea9b64-5114-40fc-a417-019ec52aa574 49288-0932 NON-STANDARDIZED ALLERGENIC Treatment Set TS350257 Treatment Set TS350257 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN 16; 800; .00008; .00008; 800; .0004 [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0933_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0933 NON-STANDARDIZED ALLERGENIC Treatment Set TS350393 Treatment Set TS350393 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; .002; .002; 800; .002; .002; .002; .0004; .00008; .0004; .002; .00008; .0002; .0002; .0004; .0002; .0002; .002; .0004; .002 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0934_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0934 NON-STANDARDIZED ALLERGENIC Treatment Set TS350394 Treatment Set TS350394 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA 16; 160; .00008; .00008; 160; .0004; .002 [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0935_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0935 NON-STANDARDIZED ALLERGENIC Treatment Set TS350534 Treatment Set TS350534 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ULMUS AMERICANA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; MORUS RUBRA POLLEN .002; 4000; 400; .002; .002; 4000; .002; .005; .005; .005; .001; .001; .0025; .0025; .002 g/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0936_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0936 NON-STANDARDIZED ALLERGENIC Treatment Set TS350533 Treatment Set TS350533 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; FESTUCA PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS; FRAXINUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; MORUS RUBRA POLLEN .0004; 10000; 4000; .005; .005; .005; .0004; .005; .0004; .002; .001; .001; .005; .002 g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0937_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0937 NON-STANDARDIZED ALLERGENIC Treatment Set TS350535 Treatment Set TS350535 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS; FRAXINUS AMERICANA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; 800; 400; 4000; .002; .002; 4000; .002; 400; .002; .002; .002; .002; .002; .002; .001; .001; .002; .002; .002 g/mL; [AU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] E 20171231 49288-0938_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0938 NON-STANDARDIZED ALLERGENIC Treatment Set TS350565 Treatment Set TS350565 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS; COCHLIOBOLUS SATIVUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 400; .0004; .002 [AU]/mL; g/mL; g/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0939_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0939 NON-STANDARDIZED ALLERGENIC Treatment Set TS350566 Treatment Set TS350566 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. SORGHUM HALEPENSE POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; BETULA LENTA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA POPULIFOLIA POLLEN; BETULA ALLEGHANIENSIS POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN; IVA XANTHIFOLIA POLLEN; IVA ANNUA VAR. ANNUA POLLEN .00008; 160; .0033; .0033; .0033; .00167; .00167; .00167; .00167; .00167; .00167; .002; .002; .002; .002; .001; .001; .001; .001 g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0940_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0940 NON-STANDARDIZED ALLERGENIC Treatment Set TS350619 Treatment Set TS350619 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. QUERCUS RUBRA POLLEN; FELIS CATUS HAIR; PHLEUM PRATENSE POLLEN .01; 304.04; 10000 g/mL; [BAU]/mL; [BAU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0941_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0941 NON-STANDARDIZED ALLERGENIC Treatment Set TS350623 Treatment Set TS350623 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; .002; 800; .002; .002; .002; .002; .002; .002; .002; .00008; .001; .001; .002; .001; .001; .002; .002; .002 g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0942_6e25c8e0-c526-446a-ae3c-33c3078f6714 49288-0942 NON-STANDARDIZED ALLERGENIC Treatment Set TS350622 Treatment Set TS350622 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN 400; .002; .002; .002; 16; 800; .0004; .00008; 160; .002 [BAU]/mL; g/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0943_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0943 NON-STANDARDIZED ALLERGENIC Treatment Set TS350663 Treatment Set TS350663 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; COCHLIOBOLUS SATIVUS; BETULA POPULIFOLIA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN 4000; 400; 4000; 4000; .002; .002; .002; 400; .002; .002; .002; .002; .002; .002; .001; .001 [AU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0944_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0944 NON-STANDARDIZED ALLERGENIC Treatment Set TS350905 Treatment Set TS350905 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; DERMATOPHAGOIDES PTERONYSSINUS; CANDIDA ALBICANS; ASPERGILLUS FUMIGATUS; PLEOSPORA HERBARUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER 16; 80; .00008; .00008; .00008; .00013; .00013; .00013; 16; .00008; .002; .0004; .00008; .002; .0005; .0005; .0005; .0005; .00008; 10.00008 [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0945_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0945 NON-STANDARDIZED ALLERGENIC Treatment Set TS350906 Treatment Set TS350906 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. POA PRATENSIS POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CYNODON DACTYLON POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; RUMEX ACETOSELLA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN 160; .0004; .000027; .000027; .000027; 16; .00008; .00008; .00008; .0004; .00004; .00004; .00008; .00008; .00008; .002; .002; .002; .002 [BAU]/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0946_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0946 NON-STANDARDIZED ALLERGENIC Treatment Set TS351004 Treatment Set TS351004 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; ALTERNARIA ALTERNATA; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; JUNIPERUS VIRGINIANA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN 80; .0004; 160; .0004; .002; .01; .002; .01; .001; .001 [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0947_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0947 NON-STANDARDIZED ALLERGENIC Treatment Set TS351003 Treatment Set TS351003 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .0002; .0002; .0004; .0004; .00008; 800; .0004; 80; 4000; .002; .00008; 4000; .0004; 400; .002; .0004; .002; .0004; .002; .00008; .00008; .002; .0004; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] E 20171231 49288-0948_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0948 NON-STANDARDIZED ALLERGENIC Treatment Set TS351030 Treatment Set TS351030 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; CANIS LUPUS FAMILIARIS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; ASPERGILLUS FUMIGATUS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; PLEOSPORA HERBARUM; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI; USTILAGO CYNODONTIS; SPORISORIUM CRUENTUM 16; 16; .0004; .002; .002; 16; .00008; .0004; .0004; .0004; .0004; .002; .0004; .002; .0004; .0001; .0001; .0001; .0001; .0002; .0002 [BAU]/mL; [AU]/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] E 20171231 49288-0949_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0949 NON-STANDARDIZED ALLERGENIC Treatment Set TS351031 Treatment Set TS351031 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; POA PRATENSIS POLLEN; KOCHIA SCOPARIA POLLEN; ULMUS AMERICANA POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN .000027; .000027; .000027; .0002; .0002; 160; .002; .002; .00008; .00008; .0004; .00008; .00008; .00008; .00008; .0004; .002; .002; .002; .002; .0004 g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE] E 20171231 49288-0950_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0950 NON-STANDARDIZED ALLERGENIC Treatment Set TS351125 Treatment Set TS351125 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; CANIS LUPUS FAMILIARIS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN .01; .002; .002; 4000; .01; 2000; .002; .002; .002; .001; .001; .002 g/mL; g/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0951_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0951 NON-STANDARDIZED ALLERGENIC Treatment Set TS351129 Treatment Set TS351129 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; FELIS CATUS HAIR; PERIPLANETA AMERICANA; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; 4000; .002; 400; .002; .002; 4000; 400; .002; .002; .002; .002; .002; .0004; .001; .001; .002; .002; .002 g/mL; [AU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0952_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0952 NON-STANDARDIZED ALLERGENIC Treatment Set TS351142 Treatment Set TS351142 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. SORGHUM HALEPENSE POLLEN; PHLEUM PRATENSE POLLEN; QUERCUS ALBA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN .01; 20000; .0033; .0033; .0033; .005; .005; .005; .005 g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0953_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0953 NON-STANDARDIZED ALLERGENIC Treatment Set TS351167 Treatment Set TS351167 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FESTUCA PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; CANIS LUPUS FAMILIARIS HAIR; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; COCHLIOBOLUS SATIVUS; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; MORUS RUBRA POLLEN; EQUUS CABALLUS HAIR; GALLUS GALLUS FEATHER; ANSER ANSER FEATHER; ANAS PLATYRHYNCHOS FEATHER; ORYCTOLAGUS CUNICULUS HAIR; ODOCOILEUS VIRGINIANUS HAIR; BOS TAURUS HAIR .002; .002; 4000; .002; 4000; 4000; .002; 400; .002; .002; .002; .002; .002; .002; .002; .002; .002; .002; .00067; .00067; .00067; .002; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient] E 20171231 49288-0954_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0954 NON-STANDARDIZED ALLERGENIC Treatment Set TS351200 Treatment Set TS351200 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; .002; .0004; 4000; .0004; .00008; .002; .002; .002; .002; .002; .002; .00004; .00004; .002; .0004; .002; .002 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0955_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0955 NON-STANDARDIZED ALLERGENIC Treatment Set TS351201 Treatment Set TS351201 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; COCHLIOBOLUS SATIVUS 400; .002; .002; 4000; .002; 2000; .01; .01 [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0957_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0957 NON-STANDARDIZED ALLERGENIC Treatment Set TS351312 Treatment Set TS351312 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; PERIPLANETA AMERICANA; DERMATOPHAGOIDES PTERONYSSINUS; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN .002; .002; 800; .002; 400; 4000; .002; .0004; 4000; .002; 400; .002; 400; .002; .002; .001; .001; .002; .002 g/mL; g/mL; [AU]/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0958_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0958 NON-STANDARDIZED ALLERGENIC Treatment Set TS351313 Treatment Set TS351313 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. URTICA DIOICA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; SALIX NIGRA POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN; EQUUS CABALLUS HAIR .002; .002; .00008; .002; .002; .002; .002; .0004; .001; .001; .002; .001; .001; .002; .002; .002; .002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0959_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0959 NON-STANDARDIZED ALLERGENIC Treatment Set TS351314 Treatment Set TS351314 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; CARYA ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; MORUS RUBRA POLLEN .002; .002; .002; .00008; 4000; .000008; .0004; .00008; .0004; .002; .0004; .0004; .00008; .00004; .00004; .002; .002; .0004 g/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-0960_57885b81-24e5-4a64-8d65-8a6517157bd9 49288-0960 NON-STANDARDIZED ALLERGENIC Treatment Set TS351315 Treatment Set TS351315 INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19861031 BLA BLA102223 Antigen Laboratories, Inc. CYNODON DACTYLON POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FELIS CATUS HAIR; DERMATOPHAGOIDES PTERONYSSINUS; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS 400; 4000; .005; .002; 160; .002; 16; 1000; .005; .005 [BAU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; [BAU]/mL; [AU]/mL; g/mL; g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 49288-9932_60ce9c8c-5855-42da-91ee-8bfe8edf51ab 49288-9932 HUMAN PRESCRIPTION DRUG Sterile Diluent for Allergenic Extract Glycerine and Phenol INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GLYCERIN; PHENOL .1; .004 mL/mL; mL/mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient] E 20171231 49288-9933_60ce9c8c-5855-42da-91ee-8bfe8edf51ab 49288-9933 HUMAN PRESCRIPTION DRUG Sterile Diluent for Allergenic Extract Phenol INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. PHENOL .004 mL/mL E 20171231 49288-9934_60ce9c8c-5855-42da-91ee-8bfe8edf51ab 49288-9934 HUMAN PRESCRIPTION DRUG Sterile Diluent for Allergenic Extract Human Albumin and Phenol INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. ALBUMIN (HUMAN); PHENOL .0003; .004 mL/mL; mL/mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] E 20171231 49288-9935_60ce9c8c-5855-42da-91ee-8bfe8edf51ab 49288-9935 HUMAN PRESCRIPTION DRUG Sterile Diluent for Allergenic Extract Glycerine INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GLYCERIN .5 mL/mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient] E 20171231 49288-9936_60ce9c8c-5855-42da-91ee-8bfe8edf51ab 49288-9936 HUMAN PRESCRIPTION DRUG Sterile Diluent for Allergenic Extract Glycerine and Phenol INJECTION, SOLUTION INTRADERMAL; SUBCUTANEOUS 19740323 BLA BLA102223 Antigen Laboratories, Inc. GLYCERIN; PHENOL .25; .004 mL/mL; mL/mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient] E 20171231 49291-0001_e661c666-7c81-4242-a856-6df998b4b23f 49291-0001 HUMAN OTC DRUG SHERO Arnica Montana, Galium Aparine, Hepar Suis, L-Isoleucine, L-Leucine, L-Valine, Pituitary (Suis), Hyaluronic Acid, IGF-1, Elk Velvet Antler LIQUID ORAL 20130913 UNAPPROVED HOMEOPATHIC Hero LLC ARNICA MONTANA; GALIUM APARINE; PORK LIVER; ISOLEUCINE; LEUCINE; VALINE; SUS SCROFA PITUITARY GLAND; HYALURONIC ACID; MECASERMIN; CERVUS ELAPHUS VELVET; LEVOCARNITINE; GLUTAMINE; PREGNENOLONE; NITRIC ACID; SOMATROPIN; NADH; COENZYME A; CHROMIUM; PRASTERONE; ARGININE PYROGLUTAMATE; FERULIC ACID; ORNITHINE .ALPHA.-KETOGLUTARATE; .ALPHA.-TOCOPHEROL; RIBOSE, D-; TRYPSIN 3; 4; 6; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 14; 30; 30; 30; 30; 30; 30; 100; 3; 4; 12; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 49291-0002_948225d1-6330-4817-8553-690cfa92f1b5 49291-0002 HUMAN OTC DRUG Hero Arnica Montana, Galium Aparine, Hepar Suis, L-Isoleucine, L-Leucine, L-Valine, Pituitary, Hyaluronic Acid, IGF-1, Elk Velvet Antler, LIQUID ORAL 20131015 UNAPPROVED HOMEOPATHIC Hero ARNICA MONTANA; GALIUM APARINE; PORK LIVER; ISOLEUCINE; LEUCINE; VALINE; SUS SCROFA PITUITARY GLAND; HYALURONIC ACID; MECASERMIN; CERVUS ELAPHUS VELVET; LEVOCARNITINE; GLUTAMINE; PREGNENOLONE; NITRIC ACID; SOMATROPIN; NADH; COENZYME A; CHROMIUM; PRASTERONE; ARGININE PYROGLUTAMATE; CREATINE MONOHYDRATE; FERULIC ACID; ORNITHINE .ALPHA.-KETOGLUTARATE; .ALPHA.-TOCOPHEROL; RIBOSE, D-; TRYPSIN 3; 4; 6; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 14; 30; 30; 30; 30; 30; 30; 100; 100; 3; 4; 12; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 49291-0003_44b80bc9-0829-42d7-b58d-c3aa5d203beb 49291-0003 HUMAN OTC DRUG Super Hero Arnica Montana, Galium Aparine, Hepar Suis, L-Isoleucine, L-Leucine, L-Valine, Pituitary, Hyaluronic Acid, IGF-1, Elk Velvet Antler, LIQUID ORAL 20131015 UNAPPROVED HOMEOPATHIC Hero ARNICA MONTANA; GALIUM APARINE; PORK LIVER; ISOLEUCINE; LEUCINE; VALINE; SUS SCROFA PITUITARY GLAND; HYALURONIC ACID; MECASERMIN; CERVUS ELAPHUS VELVET; LEVOCARNITINE; GLUTAMINE; PREGNENOLONE; NITRIC ACID; SOMATROPIN; NADH; COENZYME A; CHROMIUM; PRASTERONE; ARGININE PYROGLUTAMATE; CREATINE MONOHYDRATE; FERULIC ACID; TESTOSTERONE; ORNITHINE .ALPHA.-KETOGLUTARATE; .ALPHA.-TOCOPHEROL; RIBOSE, D-; TRYPSIN 3; 4; 6; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 14; 30; 30; 30; 30; 30; 30; 100; 100; 100; 3; 4; 12; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 49295-0001_2d9d93ea-a9c4-4601-aacd-eeba8efe2728 49295-0001 HUMAN OTC DRUG GH Human Growth Hormone, Pituitaria Glandula, Hepar Suis SPRAY ORAL 20140714 UNAPPROVED HOMEOPATHIC Oxylife Nutritional Supplements Inc SOMATROPIN; SUS SCROFA PITUITARY GLAND; PORK LIVER 30; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49299-1090_98e43dc4-f14a-498d-ac18-fc4c2695a71c 49299-1090 HUMAN PRESCRIPTION DRUG LIPITOR atorvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA020702 PHARMAKON, LLC ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 49299-1091_98e43dc4-f14a-498d-ac18-fc4c2695a71c 49299-1091 HUMAN PRESCRIPTION DRUG LIPITOR atorvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA020702 PHARMAKON, LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 49299-1092_98e43dc4-f14a-498d-ac18-fc4c2695a71c 49299-1092 HUMAN PRESCRIPTION DRUG LIPITOR atorvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA020702 PHARMAKON, LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 49299-1093_98e43dc4-f14a-498d-ac18-fc4c2695a71c 49299-1093 HUMAN PRESCRIPTION DRUG LIPITOR atorvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA020702 PHARMAKON, LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 49304-0001_5f80102b-fad2-460c-b238-8d94b56aaf49 49304-0001 HUMAN OTC DRUG Male Energy Dehydroepiandrosterone, Sabal serrulata, Setotonin, Orchitinum (suis), Pituitary (suis), Thyroidinum (suis), Conium maculatum, Testosterone, LIQUID ORAL 20120507 UNAPPROVED HOMEOPATHIC Alternative Pharmacy PRASTERONE; SAW PALMETTO; SEROTONIN; SUS SCROFA TESTICLE; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE; CONIUM MACULATUM FLOWERING TOP; TESTOSTERONE 6; 6; 6; 8; 8; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0003_6c505141-9b53-4629-b040-0b802156a079 49304-0003 HUMAN OTC DRUG Happy Bones Boron, Calcarea carbonica, Calcarea fluorica, Calcarea hypophosphorosa, Calcarea phosphorica, Hekla lava, Mezereum, Natrum phosphoricum, Silicea, Symphytum officinale, Urtica dioica, Vanadium metallicum, LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC Alternative Pharmacy BORON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CALCIUM HYPOPHOSPHITE; TRIBASIC CALCIUM PHOSPHATE; HEKLA LAVA; DAPHNE MEZEREUM BARK; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE; COMFREY ROOT; URTICA DIOICA; VANADIUM 12; 30; 8; 6; 8; 12; 6; 6; 12; 6; 4; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0004_d7d62cf3-c32b-4fb9-abd8-e6d5315275d1 49304-0004 HUMAN OTC DRUG Flexible Arnica montana, Causticum, Colchicum autumnale, Hypericum perforatum, Kalmia Latifolia, Phytolacca decandra, Rhododendrom chrysanthum, LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC Alternative Pharmacy ARNICA MONTANA; CAUSTICUM; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; URTICA URENS; ZINC 6; 6; 6; 6; 12; 6; 4; 6; 4; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0005_8b2fd8dd-9afe-4423-9318-937f7b429199 49304-0005 HUMAN OTC DRUG Cold and Flu Solution Aconitum Napellus, Belladonna, Echinacea, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ferrum Phosphoricum, Anas Barbariae, Hepatis Et Cordis Extractum LIQUID ORAL 20130910 UNAPPROVED HOMEOPATHIC Alternative Pharmacy ACONITUM NAPELLUS; ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; FERRUM PHOSPHORICUM; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 3; 3; 3; 3; 3; 4; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 49304-0006_a79e6e2e-2d65-4ab5-9231-4b1a4d996c72 49304-0006 HUMAN OTC DRUG Quiet Calm Ammonium Bromatum, Avena Sativa, Chamomilla, Coffea Cruda, Gelsemium Sempervirens, Phosphoricum Acidum LIQUID ORAL 20130306 UNAPPROVED HOMEOPATHIC Alternative Pharmacy AMMONIUM BROMIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORIC ACID; TRYPTOPHAN; VALERIAN 3; 1; 6; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0007_082f9e0b-5c1a-478c-beb4-107f5625b4f5 49304-0007 HUMAN OTC DRUG High Potency Heal Grief Ignatia Amara, Natrum Muriaticum, Staphysagria LIQUID ORAL 20130424 UNAPPROVED HOMEOPATHIC Alternative Pharmacy STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; DELPHINIUM STAPHISAGRIA SEED 200; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0009_0e83f0d8-bfb7-4883-a15f-1611f9065497 49304-0009 HUMAN OTC DRUG ADRENAL ENERGY Berberis Vulgaris, Agaricus Muscarius, Urtica Urens, Glandula Suprarenalis Bovinum, Echinacea, Atropinum Sulphuricum, Ceanothus Americanus LIQUID ORAL 20130809 20181210 UNAPPROVED HOMEOPATHIC Alternative Pharmacy BERBERIS VULGARIS ROOT BARK; AMANITA MUSCARIA FRUITING BODY; URTICA URENS; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; ECHINACEA, UNSPECIFIED; ATROPINE SULFATE; CEANOTHUS AMERICANUS LEAF 3; 3; 3; 8; 8; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0010_4892c6ea-ea0b-4500-a279-1006801c9e96 49304-0010 HUMAN OTC DRUG UR IN CONTROL Apis Mellifica, Argentum Nitricum, Belladonna, Cantharis, Causticum, Equsetum Arvense, Petroselinum Sativum, Pulsatilla, Sarsaparilla, Terebinthina LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC Alternative Pharmacy APIS MELLIFERA; SILVER NITRATE; ATROPA BELLADONNA; LYTTA VESICATORIA; CAUSTICUM; EQUISETUM ARVENSE TOP; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SARSAPARILLA; TURPENTINE OIL 6; 6; 4; 6; 8; 6; 8; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0011_52739b96-46d8-4166-a655-a478be6a73b4 49304-0011 HUMAN OTC DRUG Stay Well Argentum Nitricum, Baptisia Tinctoria, Echinacea, Echinacea Purpurea, Galium Aparine, Phosphorus, Pulstilla, Sulphur, Thuma Occidentalis, Thymus Serpyllum LIQUID ORAL 20130821 UNAPPROVED HOMEOPATHIC Alternative Pharmacy SILVER NITRATE; BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; GALIUM APARINE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; THUJA OCCIDENTALIS LEAF; THYMUS SERPYLLUM 6; 6; 6; 3; 6; 6; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0012_3ed1caa2-68b9-4773-8f06-f99fe25bfd7a 49304-0012 HUMAN OTC DRUG Thyroid Rhythm Adrenalinum, Calarea Carbonica, Calcarea Fluorica, Calcarea Iodata, Ferrum Iodatum, Fucus Vesiculosus, Iodium, Kali Iodatum, Naturm Muriaticum LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC Alternative Pharmacy EPINEPHRINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CALCIUM IODIDE; FERROUS IODIDE; FUCUS VESICULOSUS; IODINE; POTASSIUM IODIDE; SODIUM CHLORIDE; BOS TAURUS PITUITARY GLAND; BOS TAURUS SPLEEN; SPONGIA OFFICINALIS SKELETON, ROASTED; BOS TAURUS THYMUS; SUS SCROFA THYROID 6; 30; 8; 6; 8; 6; 9; 6; 30; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0013_90d29cd7-aa5f-48c2-9f65-62a2a53fbf50 49304-0013 HUMAN OTC DRUG Energize Aralia QuinQuefolia, Avena Sativa, Kali Phosphoricum, Phosphoricum Acidum, Picricum Acidum, Zingiber Officinale LIQUID ORAL 20131002 UNAPPROVED HOMEOPATHIC Alternate Pharmacy AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; PHOSPHORIC ACID; PICRIC ACID; GINGER 6; 3; 12; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0014_168698de-198c-449c-a71b-01711b31f383 49304-0014 HUMAN OTC DRUG Happy Happy not applicable LIQUID ORAL 20140724 UNAPPROVED HOMEOPATHIC Alternative Pharmacy GOLD; LITHIUM CARBONATE; SEROTONIN HYDROCHLORIDE 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0015_2d19a4f7-9faf-4c52-8fbd-fe4fab43f725 49304-0015 HUMAN OTC DRUG Stomach Relief not applicable LIQUID ORAL 20140724 UNAPPROVED HOMEOPATHIC Alternative Pharmacy ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; STRYCHNOS NUX-VOMICA SEED; ROBINIA PSEUDOACACIA BARK 30; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 49304-0016_822f03f1-1ffd-4e57-a3f5-c9d0e9b1c534 49304-0016 HUMAN OTC DRUG Trauma Drama Arnica Montana, Belladonna, Bellis Perennis, Calendula Officinalis, Chamomilla, Hypericum Perforatum, Mercurius Solubilis, Rhus Tox, Ruta Graveolens, Symphytum Officinale LIQUID ORAL 20140724 UNAPPROVED HOMEOPATHIC Alternative Pharmacy ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; MERCURIUS SOLUBILIS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 30; 6; 6; 6; 6; 6; 12; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 49304-0017_47a8d661-1deb-4a86-b432-cbf6382d5f6e 49304-0017 HUMAN OTC DRUG TICKED Not applicable LIQUID ORAL 20140724 UNAPPROVED HOMEOPATHIC Alternative Pharmacy ACONITUM NAPELLUS; EPINEPHRINE; ARNICA MONTANA; BORRELIA BURGDORFERI; CALENDULA OFFICINALIS FLOWERING TOP; LEDUM PALUSTRE TWIG; PHYTOLACCA AMERICANA ROOT 30; 8; 30; 12; 3; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0018_ccd9fbab-7033-440e-9f40-519986a609bd 49304-0018 HUMAN OTC DRUG Happy Heart not applicable LIQUID ORAL 20140724 UNAPPROVED HOMEOPATHIC Alternative Pharmacy ACONITUM NAPELLUS; ARNICA MONTANA; SELENICEREUS GRANDIFLORUS STEM; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; POTASSIUM CARBONATE; RANUNCULUS BULBOSUS; SPIGELIA ANTHELMIA; SULFUR 30; 30; 4; 10; 6; 6; 10; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0019_d8281b61-62c0-4488-a906-d00cbec1791c 49304-0019 HUMAN OTC DRUG Adrenal Energy NOT APPLICABLE LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC Alternative Pharmacy AMANITA MUSCARIA FRUITING BODY; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; CEANOTHUS AMERICANUS LEAF; ECHINACEA ANGUSTIFOLIA; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; URTICA URENS 3; 12; 3; 12; 12; 8; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49304-0020_09c56e7a-7a80-4369-a4bb-6a57ef7d5f94 49304-0020 HUMAN OTC DRUG Nighty Nite NOT APPLICABLE LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC Alternative Pharmacy GRINDELIA HIRSUTULA WHOLE; MELATONIN; PASSIFLORA INCARNATA FLOWERING TOP 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49310-001_6455f4f4-9523-4243-8e36-d0025643b3ce 49310-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090501 NDA NDA205889 Fairmont Home Equipment & Supply OXYGEN 990 mL/L N 20181231 49314-0098_018e7378-c05c-47ed-bed1-c5d4ce426261 49314-0098 HUMAN OTC DRUG First Aid Antiseptic benzalkonium chloride and benzocaine SPRAY TOPICAL 20150127 OTC MONOGRAPH NOT FINAL part333A Unishield BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/g; mg/g N 20181231 49314-5801_ce039b46-d1d2-40bf-9a2c-d5c177793fb2 49314-5801 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20100728 OTC MONOGRAPH FINAL part348 UniShield HYDROCORTISONE 10 mg/mL N 20181231 49317-001_aa44f437-54e3-439e-9b2c-4d3ccf219854 49317-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS Abbott Welding Supply OXYGEN 995 mL/L E 20171231 49344-0001_d5968e24-6663-4f42-bfc0-9547496ca765 49344-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091110 UNAPPROVED MEDICAL GAS Westmoreland Medical Equipment Company OXYGEN 99 L/100L E 20171231 49348-001_8f85f9af-cf27-45a0-b953-2b18d98db714 49348-001 HUMAN OTC DRUG Sunmark Aspirin Regular Strength Aspirin TABLET ORAL 20030624 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 325 mg/1 N 20181231 49348-002_c6864411-6fb4-44a4-b0f1-3b3483349c59 49348-002 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 49348-003_841eb1c1-7154-4e0f-b6d2-43884d906ccf 49348-003 HUMAN OTC DRUG Ethyl Rubbing Alcohol alcohol LIQUID TOPICAL 20090416 OTC MONOGRAPH NOT FINAL part333A McKesson (Sunmark) ALCOHOL 70 mL/100mL N 20181231 49348-004_529f8b58-e86e-4eaf-bec2-b58b96451ceb 49348-004 HUMAN OTC DRUG Isopropyl rubbing alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141130 OTC MONOGRAPH NOT FINAL part333A McKesson (Sunmark) ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 49348-005_40892738-fa0d-4ab4-8609-3c4eda46be7e 49348-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 McKesson SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 49348-006_c58744ba-2de1-4157-a0eb-78f89239c4fc 49348-006 HUMAN OTC DRUG Mineral Oil Lubricant Laxative mineral oil ENEMA RECTAL 20120716 OTC MONOGRAPH NOT FINAL part334 McKesson MINERAL OIL 118 mL/118mL E 20171231 49348-007_06450d9c-0be5-4f38-834d-df3d9da63471 49348-007 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 percent Wintergreen Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A McKesson (Sunmark) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 49348-010_1de42f97-b375-47a9-984a-52d79a6d2588 49348-010 HUMAN OTC DRUG sunmark dual action complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160114 ANDA ANDA077355 McKesson FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 49348-011_602cb0ae-4368-7ac2-e053-2a91aa0a60b6 49348-011 HUMAN OTC DRUG Sunmark Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 McKesson ZINC OXIDE 160 mg/mL N 20181231 49348-013_bf1f9e85-7fc0-4513-9d2d-ba8268622196 49348-013 HUMAN OTC DRUG Stool Softener With Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 49348-014_5dac558a-b181-4389-ab0b-77ced08d478d 49348-014 HUMAN OTC DRUG Sunmark stomach relief Bismuth subsalicylate SUSPENSION ORAL 20160212 OTC MONOGRAPH FINAL part335 Mckesson BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 49348-016_602d10fc-10a7-c1dd-e053-2a91aa0a675e 49348-016 HUMAN OTC DRUG Sunmark Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 McKesson CASTOR OIL 1 mg/mL N 20181231 49348-017_81c2e572-162f-4e9e-b2f1-309927261b92 49348-017 HUMAN OTC DRUG Sun Mark Tussin DM cough and chest congestion Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 20030627 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 49348-018_82dc9662-efff-4562-93ea-3cd12c1fb8e3 49348-018 HUMAN OTC DRUG Epsom Salt Magnesium sulfate GRANULE ORAL; TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) MAGNESIUM SULFATE 1 g/g N 20181231 49348-019_e12821b1-8919-4129-9a93-1a5949b52bd7 49348-019 HUMAN OTC DRUG Sunmark Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20030913 OTC MONOGRAPH FINAL part332 McKesson ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 49348-020_b2c1d690-33bc-4094-8629-09949f4c1502 49348-020 HUMAN OTC DRUG sunmark antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20030821 OTC MONOGRAPH FINAL part331 Mckesson ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 49348-024_af2e7d91-28ac-431c-bb92-a9041c6d16b4 49348-024 HUMAN OTC DRUG Sunmark Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20030815 OTC MONOGRAPH FINAL part341 McKesson PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 49348-025_b3aa336f-d20e-4490-ad26-82060b20c555 49348-025 HUMAN OTC DRUG Sun Mark Allergy Antihistamine Chlorpheniramine Maleate TABLET ORAL 20030919 OTC MONOGRAPH FINAL part341 McKesson CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 49348-026_cc539679-b068-4d74-a885-b3801b84c5e6 49348-026 HUMAN OTC DRUG acid reducer Ranitidine TABLET ORAL 20140107 ANDA ANDA200536 McKesson RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 49348-028_378783d7-b473-426b-9bc0-1d421f9d0e78 49348-028 HUMAN OTC DRUG Sunmark Nasal Original oxymetazoline hydrochloride SPRAY NASAL 20030627 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 49348-029_45df6359-262f-442a-bdd5-c7d62d43a449 49348-029 HUMAN OTC DRUG sunmark triple antibiotic polymyxin B sulfate, bacitracin zinc, and neomycin sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B McKesson BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 49348-030_6039f6da-7f26-3839-e053-2a91aa0a7ad2 49348-030 HUMAN OTC DRUG sunmark Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL LIQUID TOPICAL 20120628 OTC MONOGRAPH NOT FINAL part333A McKesson ISOPROPYL ALCOHOL 70 L/100L N 20181231 49348-032_cbd1da13-803e-498b-959f-6c93501d6f3f 49348-032 HUMAN OTC DRUG gentle laxative Bisacodyl TABLET, COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) BISACODYL 5 mg/1 N 20181231 49348-037_d1a8e105-763a-48f9-92e4-7375bf055297 49348-037 HUMAN OTC DRUG Sunmark Eye Drops Original Formula Tetrahydrozoline HCl LIQUID OPHTHALMIC 20070301 OTC MONOGRAPH FINAL part349 McKesson Corporation TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 49348-039_1f694d67-5e41-4bc4-b2d6-1fd0f1d5da1b 49348-039 HUMAN OTC DRUG Healing Petrolatum OINTMENT TOPICAL 20130801 OTC MONOGRAPH FINAL part347 McKesson PETROLATUM 340 mg/g N 20181231 49348-042_f94b8360-6000-4b5d-ac8f-88f7d5145764 49348-042 HUMAN OTC DRUG Sunmark pain reliever extra strength Acetaminophen TABLET ORAL 20030811 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 N 20181231 49348-045_da361df5-dd70-470b-97b6-a7aee889a768 49348-045 HUMAN OTC DRUG Sunmark Allergy Relief Antihistamine Diphenhydramine Hydrochloride SOLUTION ORAL 20030821 OTC MONOGRAPH FINAL part341 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 49348-047_9bde93d4-81fc-4461-b77e-5f75d49dd0b6 49348-047 HUMAN OTC DRUG Original texture Orange flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20061227 OTC MONOGRAPH NOT FINAL part334 Sunmark PSYLLIUM HUSK 3.4 g/11g N 20181231 49348-055_efc1f7f7-d605-4ce3-8205-6f19f52f5086 49348-055 HUMAN OTC DRUG SUNMARK Calcium Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20130808 OTC MONOGRAPH FINAL part331 Mckesson CALCIUM CARBONATE 750 mg/1 N 20181231 49348-056_ea16aeba-89fc-4246-b244-4c3f1b267791 49348-056 HUMAN OTC DRUG Childrens allergy relief antihistamine LIQUID ORAL 20130808 OTC MONOGRAPH FINAL part341 Mckesson DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 49348-061_139c1945-f1ee-4e6b-a020-27950b898c04 49348-061 HUMAN OTC DRUG sunmark nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20111121 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 49348-062_190803e2-7f05-4916-92bf-4513fbd51f44 49348-062 HUMAN OTC DRUG Senna laxative Natural vegetable laxative SENNOSIDES TABLET ORAL 20130220 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) SENNOSIDES 8.6 mg/1 N 20181231 49348-063_ff130d3b-4acc-4a1b-80b9-4077f6e672b3 49348-063 HUMAN OTC DRUG Sunmark Junior Rapid Melts Acetaminophen TABLET, CHEWABLE ORAL 20130801 OTC MONOGRAPH NOT FINAL part343 Mckesson ACETAMINOPHEN 160 mg/1 N 20181231 49348-070_e7855bd6-96cd-41e9-8f07-5937863fa8e9 49348-070 HUMAN OTC DRUG Motion Sickness Original formula Dimenhydrinate TABLET ORAL 20110613 OTC MONOGRAPH FINAL part336 McKesson (Sunmark) DIMENHYDRINATE 50 mg/1 N 20181231 49348-073_0d3cfc5d-eb0c-4a44-ac16-6404752945d5 49348-073 HUMAN OTC DRUG gas relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part332 McKesson (Sunmark) DIMETHICONE 125 mg/1 N 20181231 49348-074_96227853-31b8-42d1-bb9f-959be3e118d0 49348-074 HUMAN OTC DRUG Sleep Aid maximum strength Diphenhydramine HCl CAPSULE ORAL 20100709 OTC MONOGRAPH FINAL part341 Mckesson (Sunmark) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 49348-076_6ae78778-70a2-4d82-a3ce-ae82127e055b 49348-076 HUMAN OTC DRUG Sunmark Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER Mckesson PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 49348-077_9d01dd36-d079-4d65-b8b0-1fbd345b35fc 49348-077 HUMAN OTC DRUG Alcohol Pad isopropyl alcohol SWAB TOPICAL 20030619 OTC MONOGRAPH NOT FINAL part333E McKesson ISOPROPYL ALCOHOL .7 mL/1 E 20171231 49348-078_58e4bb07-ab4b-4beb-a182-f6f85d85eefa 49348-078 HUMAN OTC DRUG Childrens all day allergy Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 49348-080_05ae4cbe-51c1-404d-94b6-f96c778a35a5 49348-080 HUMAN OTC DRUG adult cold, flu and sore throat acteaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 1/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 49348-081_49a37879-7659-42e2-b21a-174bbd6c60d6 49348-081 HUMAN OTC DRUG Sunmark Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20111025 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL N 20181231 49348-082_3e0e2dba-cd80-4e1b-b0cb-6e8e918889ec 49348-082 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH FINAL part347 McKesson (Sunmark) DIMETHICONE 125 mg/1 N 20181231 49348-083_22d26c0a-b9f5-4130-89a4-32aab896ece5 49348-083 HUMAN OTC DRUG adult severe congestion and cough Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Mckesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 49348-090_733836c8-642d-460f-9414-be13e1534fc2 49348-090 HUMAN OTC DRUG Sunmark fiber Smooth Texture psyllium husk POWDER, FOR SUSPENSION ORAL 20061227 OTC MONOGRAPH NOT FINAL part334 McKesson PSYLLIUM HUSK 3.4 g/5.8g N 20181231 49348-091_f6e43342-8b0c-48ac-a7b6-75466ee1fab0 49348-091 HUMAN OTC DRUG Smooth texture Orange flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20070405 OTC MONOGRAPH NOT FINAL part334 McKesson PSYLLIUM HUSK 3.4 g/12g N 20181231 49348-093_e0d535d2-3518-415d-b29e-59c5ea3f503c 49348-093 HUMAN OTC DRUG Sunmark childrens pain and fever Acetaminophen SUSPENSION ORAL 20140124 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL N 20181231 49348-094_50cb8f34-06d9-4b1f-bcb6-60470b45e6ff 49348-094 HUMAN OTC DRUG sunmark calcium antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160303 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 750 mg/1 N 20181231 49348-095_c6c6ffb9-b924-4cec-8192-044fd248db7f 49348-095 HUMAN OTC DRUG Dry eye relief Glycerin, Hypromellose, Polyethylene glycol LIQUID OPHTHALMIC 20130501 OTC MONOGRAPH FINAL part349 McKesson Corporation HYPROMELLOSES; GLYCERIN; POLYETHYLENE GLYCOL 400 .2; .2; 1 g/100mL; g/100mL; g/100mL N 20181231 49348-097_0871053e-dabb-4db1-8363-3be7a4d80ea9 49348-097 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Sunmark IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 49348-100_dbcf83f0-c2e1-4bfc-8070-f69b5046d9c3 49348-100 HUMAN OTC DRUG Sunmark cough dm dextromethorphan polistirex SUSPENSION ORAL 20130618 ANDA ANDA091135 McKesson DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 49348-104_d04248cb-5e64-4978-93ed-f9b0918b5d90 49348-104 HUMAN OTC DRUG sunmark cold and flu severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20080319 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49348-106_335bb5ae-2e1a-4c3c-89ba-017d52125558 49348-106 HUMAN OTC DRUG sunmark calcium antacid calcium carbonate TABLET, CHEWABLE ORAL 20160304 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 500 mg/1 N 20181231 49348-107_36f43472-05f0-40c3-be10-08489ad3084e 49348-107 HUMAN OTC DRUG eye itch relief ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC 20140207 ANDA ANDA077958 McKesson Corporation Valu-Rite KETOTIFEN FUMARATE .35 mg/mL N 20181231 49348-108_4c3a0723-4895-4b13-86f8-52f30653f7d4 49348-108 HUMAN OTC DRUG sunmark calcium antacid calcium carbonate TABLET, CHEWABLE ORAL 20160303 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 500 mg/1 N 20181231 49348-109_bdf8a661-100c-45bf-ac0f-4aef41cd90b2 49348-109 HUMAN OTC DRUG Sunmark acid reducer Ranitidine TABLET, FILM COATED ORAL 20160614 ANDA ANDA091429 Mckesson RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 49348-110_256cf9d9-67d1-4f6c-abed-42b9cd7604fc 49348-110 HUMAN OTC DRUG Oral Saline Laxative Cherry dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120831 OTC MONOGRAPH NOT FINAL part334 McKesson Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.7; 7.2 g/15mL; g/15mL E 20171231 49348-111_37d2d0d2-ed3d-485e-be10-6c29c509e678 49348-111 HUMAN OTC DRUG Oral Saline Laxative Ginger Lemon dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120831 OTC MONOGRAPH NOT FINAL part334 Mckesson Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.7; 7.2 g/15mL; g/15mL E 20171231 49348-112_fea30ab2-45bc-409b-8296-a4b4f71a4a99 49348-112 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20160601 ANDA ANDA075209 Sunmark LORATADINE 10 mg/1 N 20181231 49348-113_9d9b9078-ee47-49dd-a61b-88b6a72f98fe 49348-113 HUMAN OTC DRUG Sunmark mucus relief d Guaifenesin, pseudoephedrine hydrochloride TABLET ORAL 20151221 ANDA ANDA091071 McKesson GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 49348-115_26f1aac0-c4b4-217a-e054-00144ff88e88 49348-115 HUMAN OTC DRUG Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% LIQUID TOPICAL 20140220 NDA NDA019125 McKesson CHLORHEXIDINE GLUCONATE 4 mg/100mL N 20181231 49348-116_062dd7dd-a069-58a1-e054-00144ff8d46c 49348-116 HUMAN OTC DRUG Pain Reliever Rapid Release Acetaminophen TABLET, COATED ORAL 20141024 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 N 20181231 49348-117_066afeed-a4af-3c5e-e054-00144ff8d46c 49348-117 HUMAN OTC DRUG Sinus Congestion and Pain Severe ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141027 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 49348-118_066afeed-a4c3-3c5e-e054-00144ff8d46c 49348-118 HUMAN OTC DRUG Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141027 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49348-119_0fea928a-ad8c-4682-b4fe-efe8e7328eaa 49348-119 HUMAN OTC DRUG sunmark childrens pain and fever Acetaminophen SUSPENSION ORAL 20140428 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL N 20181231 49348-121_769bd49f-24e5-47fe-bc1a-441f65eefc22 49348-121 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE ORAL 20140530 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) DOCUSATE SODIUM 100 mg/1 N 20181231 49348-122_42fc9282-1fde-42db-a1e5-ef3cbd63189a 49348-122 HUMAN OTC DRUG stool softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20140530 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) DOCUSATE CALCIUM 240 mg/1 N 20181231 49348-123_89791b9c-70b6-4f2b-be28-bf86248948e4 49348-123 HUMAN OTC DRUG Sunmark Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140519 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL N 20181231 49348-125_4a9549f1-a018-46d6-aa63-cac9f7545628 49348-125 HUMAN OTC DRUG STOOL SOFTENER EXTRA STRENGTH DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140530 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) DOCUSATE SODIUM 250 mg/1 N 20181231 49348-126_5c6d7fb2-a6bc-491c-b9bd-9f80fd54fa7c 49348-126 HUMAN OTC DRUG sunmark lice solution Piperonyl butoxide, pyrethrum extract KIT 20170306 OTC MONOGRAPH FINAL part358G McKesson N 20181231 49348-128_877e9b4a-f852-4e8e-b22d-3a5c2c2c3cff 49348-128 HUMAN OTC DRUG sunmark acid reducer Famotidine TABLET ORAL 20090910 ANDA ANDA075400 Mckesson FAMOTIDINE 10 mg/1 N 20181231 49348-130_4ec6376e-d1f8-44d5-b9fc-82874af1de01 49348-130 HUMAN OTC DRUG sunmark nasal Oxymetazoline HCl SPRAY NASAL 20140926 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 49348-131_59f8882f-4193-4ecf-a4ec-75dcbd82739c 49348-131 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20141231 OTC MONOGRAPH FINAL part347 McKesson (Sunmark) WITCH HAZEL 842 mg/mL N 20181231 49348-133_4ff55a3c-b85f-4490-87f3-51181e63a8bc 49348-133 HUMAN OTC DRUG Sunmark Iodine IODINE, SODIUM IODIDE, ALCOHOL TINCTURE TOPICAL 20120628 OTC MONOGRAPH FINAL part333A McKesson IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 49348-135_961abc8a-f8ba-497c-8547-f31e411c23d4 49348-135 HUMAN OTC DRUG sunmark tussin Guaifenesin SOLUTION ORAL 20140917 OTC MONOGRAPH FINAL part341 McKesson GUAIFENESIN 200 mg/10mL N 20181231 49348-136_009be4d3-555a-4f90-a8e8-a455b2524a30 49348-136 HUMAN OTC DRUG Sunmark acid reducer Ranitidine TABLET, COATED ORAL 20160523 ANDA ANDA076195 Mckesson RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 49348-138_602ca757-595b-c507-e053-2991aa0a14b4 49348-138 HUMAN OTC DRUG Sunmark Benzoin Compound Tincture Benzoin Resin LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part356 McKesson BENZOIN RESIN 1000 mg/mL N 20181231 49348-140_bf922605-99ef-4249-b2f7-ce9e07d7c6e4 49348-140 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20141231 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 49348-142_532e15bc-060e-4134-8859-cd7c0e59682d 49348-142 HUMAN OTC DRUG Day Time Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20150930 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 49348-143_3c0395a5-784a-299a-e054-00144ff8d46c 49348-143 HUMAN OTC DRUG CLEARLAX polyethylene glycol 3350 POWDER, FOR SOLUTION ORAL 20160701 ANDA ANDA090812 MCKESSON (SUNMARK) POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 49348-144_4c503a65-ce34-4bda-7957-b37f78b900f8 49348-144 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20151102 NDA NDA020076 Mckesson (Sun Mark) NICOTINE 21 mg/24h N 20181231 49348-145_4c503a65-ce34-4bda-7957-b37f78b900f8 49348-145 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20151102 NDA NDA020076 Mckesson (Sun Mark) NICOTINE 14 mg/24h N 20181231 49348-146_4c503a65-ce34-4bda-7957-b37f78b900f8 49348-146 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20151102 NDA NDA020076 Mckesson (Sun Mark) NICOTINE 7 mg/24h N 20181231 49348-147_3bed0156-9a66-42b8-e054-00144ff8d46c 49348-147 HUMAN OTC DRUG GAS RELIEF Simethicone TABLET, CHEWABLE ORAL 20160401 OTC MONOGRAPH FINAL part332 MCKESSON (SUNMARK) DIMETHICONE 80 mg/1 N 20181231 49348-148_602cca55-3268-0eba-e053-2991aa0abe66 49348-148 HUMAN OTC DRUG Sunmark Camphor Spirit Camphor 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 McKesson CAMPHOR (NATURAL) 100 mg/mL N 20181231 49348-149_dd98a470-73f3-4869-977e-4b79e8b76809 49348-149 HUMAN OTC DRUG Sunmark Lubricating Tears Polyethylene glycol 400, Propylene glycol LIQUID OPHTHALMIC 20130501 OTC MONOGRAPH FINAL part349 McKesson Corporation POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL N 20181231 49348-150_b20a2395-d3a5-48ff-b19b-089411fcc0d1 49348-150 HUMAN OTC DRUG sunmark lice treatment Permethrin LOTION TOPICAL 20150803 ANDA ANDA076090 Mckesson PERMETHRIN 1 mg/100mL N 20181231 49348-151_d9494ae1-6ce9-4ab1-85de-f39629fc19f2 49348-151 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20150731 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 49348-153_3ac2be80-bfd4-06a8-e054-00144ff8d46c 49348-153 HUMAN OTC DRUG ADVANCED ANTACID REGULAR STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20120601 OTC MONOGRAPH FINAL part331 MCKESSON (SUNMARK) ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 49348-154_75e3ef84-b7c8-440c-ac49-42bd8f7d5ca2 49348-154 HUMAN OTC DRUG antibiotic Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B McKesson BACITRACIN ZINC 500 [iU]/g N 20181231 49348-155_155ba245-491d-4a85-be99-f49786e61cd9 49348-155 HUMAN OTC DRUG sunmark antifungal Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C McKesson TOLNAFTATE 10 mg/g N 20181231 49348-156_3b625ff6-ffa8-6ac6-e054-00144ff8d46c 49348-156 HUMAN OTC DRUG SENNA-S Sennosides and Docusate Sodium TABLET, FILM COATED ORAL 20160201 OTC MONOGRAPH NOT FINAL part334 SUNMARK (MCKESSON) SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 49348-157_6f6b750e-8e3c-4fd0-b2ca-d45c68e931cf 49348-157 HUMAN OTC DRUG Nighttime cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20150930 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 49348-158_6813476e-56c3-4726-8579-17d570c9fb30 49348-158 HUMAN OTC DRUG Infant Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20050909 OTC MONOGRAPH FINAL part334 McKesson GLYCERIN 1.3 g/1 E 20171231 49348-159_d4b0c77c-9a3d-4bae-b4f9-bf6defbdc796 49348-159 HUMAN OTC DRUG Adult Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20050803 OTC MONOGRAPH FINAL part334 McKesson GLYCERIN 1.614 g/1 E 20171231 49348-162_676d80c0-16a1-4f21-ad43-c2e2c6117f2b 49348-162 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 20150930 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49348-165_3b4dc404-146f-26c0-e054-00144ff8d46c 49348-165 HUMAN OTC DRUG SENNA LAXATIVE Sennosides TABLET ORAL 20160201 OTC MONOGRAPH NOT FINAL part334 MCKESSON (SUNMARK) SENNOSIDES 8.6 mg/1 N 20181231 49348-166_fc371d60-ee74-48e9-9848-fc45de771053 49348-166 HUMAN OTC DRUG Fiber original texture psyllium husk POWDER, FOR SUSPENSION ORAL 20070115 OTC MONOGRAPH NOT FINAL part334 McKesson PSYLLIUM HUSK 3.4 g/7g N 20181231 49348-167_3ec5a0f8-ac26-2f84-e054-00144ff88e88 49348-167 HUMAN OTC DRUG STOOL SOFTENER docusate sodium TABLET ORAL 20160301 OTC MONOGRAPH NOT FINAL part334 McKesson DOCUSATE SODIUM 100 mg/1 N 20181231 49348-171_3a3680e8-02a1-6a58-e054-00144ff8d46c 49348-171 HUMAN OTC DRUG SUNMARK MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20120401 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 49348-173_6039fb14-e278-08fb-e053-2991aa0a495a 49348-173 HUMAN OTC DRUG Sunmark Isopropyl Rubbing Alcohol 70 Percent isopropyl alcohol LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A McKesson ISOPROPYL ALCOHOL 700 mg/mL N 20181231 49348-174_602d0c43-53cc-d221-e053-2a91aa0a81a9 49348-174 HUMAN OTC DRUG Sunmark Isopropyl Alcohol 91 Percent isopropyl alcohol LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A McKesson ISOPROPYL ALCOHOL 910 mg/mL N 20181231 49348-175_603a1d63-4768-441b-e053-2991aa0abc97 49348-175 HUMAN OTC DRUG Sunmark Isopropyl Alcohol 70 Percent With Wintergreen Oil isopropyl alcohol LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A McKesson ISOPROPYL ALCOHOL 700 mg/mL N 20181231 49348-179_602c529d-170f-5011-e053-2a91aa0a0295 49348-179 HUMAN OTC DRUG Sunmark Hydrogen Peroxide 3 Percent hydrogen peroxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A McKesson HYDROGEN PEROXIDE 30 mg/mL N 20181231 49348-181_603a3e9c-367d-7cb9-e053-2a91aa0a4d1f 49348-181 HUMAN OTC DRUG Sunmark Witch Hazel Witch Hazel LIQUID TOPICAL 20160101 OTC MONOGRAPH FINAL part347 McKesson WITCH HAZEL 855 mg/mL N 20181231 49348-182_c992112b-e8c5-4cdc-ba75-1625947f8cad 49348-182 HUMAN OTC DRUG SunMark allergy relief nasal 24 hr Fluticasone propionate SPRAY, METERED NASAL 20160529 ANDA ANDA207957 Mckesson FLUTICASONE PROPIONATE 50 ug/1 N 20191231 49348-183_ec0dc654-1569-4dbc-8dd0-ceacea213711 49348-183 HUMAN OTC DRUG sunmark loratadine d Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120306 ANDA ANDA076050 McKesson LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 49348-185_baa745b0-4aae-4570-8fdd-8968a7cfd095 49348-185 HUMAN OTC DRUG Sunmark Mineral Oil Laxative Mineral Oil ENEMA RECTAL 20021113 OTC MONOGRAPH NOT FINAL part334 McKesson MINERAL OIL 118 g/118mL N 20181231 49348-186_f7cc405a-c69f-4335-888f-5caa57e4c017 49348-186 HUMAN OTC DRUG Sunmark Saline Single Laxative Sodium Phosphate, Dibasic and Sodium Phosphate, Monobasic, Unspecified Form ENEMA RECTAL 20130306 OTC MONOGRAPH NOT FINAL part334 McKesson SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 7; 19 g/118mL; g/118mL N 20181231 49348-187_5086db04-bd5b-49ca-af47-059bb489b4f7 49348-187 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20151130 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 49348-188_429bf336-72ab-6722-e054-00144ff88e88 49348-188 HUMAN OTC DRUG GAS RELIEF Simethicone TABLET, CHEWABLE ORAL 20160401 OTC MONOGRAPH FINAL part332 MCKESSON (SUNMARK) DIMETHICONE 80 mg/1 N 20181231 49348-189_b785bc88-afce-457c-a6da-29070a3c1a21 49348-189 HUMAN OTC DRUG Senna laxative Sennosides TABLET ORAL 20151130 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) SENNOSIDES 8.6 mg/1 N 20181231 49348-190_ea679572-1a4b-46cb-8b00-0cf0c6342fec 49348-190 HUMAN OTC DRUG Fiber Caplets CALCIUM POLYCARBOPHIL TABLET ORAL 20160601 OTC MONOGRAPH NOT FINAL part334 Mckesson CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 49348-191_babf9ee4-5bc2-48a4-ab23-022149abea52 49348-191 HUMAN OTC DRUG sunmark aspirin Aspirin TABLET, CHEWABLE ORAL 20030906 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 N 20181231 49348-193_0e2c15bc-2f1e-44a2-b199-33a88078754d 49348-193 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) SENNOSIDES 25 mg/1 N 20181231 49348-196_a8507ff0-b9ab-415d-acbc-ea424e35d12c 49348-196 HUMAN OTC DRUG sunmark ibuprofen Ibuprofen TABLET, COATED ORAL 20030624 ANDA ANDA072096 McKesson IBUPROFEN 200 mg/1 N 20181231 49348-197_347209d3-6bff-4cd1-84f9-57e57f54d05d 49348-197 HUMAN OTC DRUG Sunmark Nose Phenylephrine hydrochloride SOLUTION/ DROPS NASAL 20030821 OTC MONOGRAPH FINAL part341 McKesson PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 49348-198_96272510-a5ac-45eb-b693-4ccd1df85405 49348-198 HUMAN OTC DRUG Sunmark Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20160725 OTC MONOGRAPH FINAL part346 Mckesson MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 49348-199_40357721-64f9-42ea-b457-86dc0dc6c551 49348-199 HUMAN OTC DRUG Sunmark mucus relief DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160711 ANDA ANDA091070 Mckesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 49348-224_c318abc8-00ea-4d3f-b3d3-768e86f1c819 49348-224 HUMAN OTC DRUG Laxative pills maximum strength Sennosides TABLET ORAL 20100710 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) SENNOSIDES 25 mg/1 N 20181231 49348-225_51e6d388-56c6-48cd-8a86-b84b922853ae 49348-225 HUMAN OTC DRUG Sunmark allergy relief Chlorpheniramine Maleate TABLET ORAL 20160713 OTC MONOGRAPH FINAL part341 Mckesson CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 49348-229_f8a3bca0-5c10-4524-8f4c-b0633c6c90e1 49348-229 HUMAN OTC DRUG sunmark ibuprofen Ibuprofen SUSPENSION ORAL 20030919 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL N 20181231 49348-230_2ae13282-c942-4f64-afa8-6903cf9f41f4 49348-230 HUMAN OTC DRUG sunmark nasal Oxymetazoline HCl SPRAY NASAL 20030919 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 49348-231_a99b482f-9a9e-4893-8344-7898f56f4289 49348-231 HUMAN OTC DRUG Sunmark Nasal oxymetazoline hydrochloride SPRAY NASAL 20030624 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 49348-233_b6b94f7e-e500-400b-bdef-0f3ff497d469 49348-233 HUMAN OTC DRUG PAIN RELIEVER PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130308 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 49348-236_cc2bf895-7f57-46a3-9281-33746dc84e2d 49348-236 HUMAN OTC DRUG pain reliever pm extra strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20130326 OTC MONOGRAPH NOT FINAL part343 McKesson (Sunmark) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 49348-246_af3fb1fb-9871-46d7-b8ff-ab6fcb804283 49348-246 HUMAN OTC DRUG SunMark heartburn relief acid reducer Cimetidine TABLET ORAL 20030919 ANDA ANDA075285 McKesson CIMETIDINE 200 mg/1 N 20181231 49348-260_e8434137-f58d-47e7-8849-e3264b01338d 49348-260 HUMAN OTC DRUG Sunmark Naproxen Sodium Naproxen Sodium TABLET ORAL 20030821 ANDA ANDA074661 McKesson NAPROXEN SODIUM 220 mg/1 N 20181231 49348-262_b31f9a7e-d5b3-489b-8595-ec4a4c6b75e4 49348-262 HUMAN OTC DRUG Senna laxative Natural vegetable laxative SENNOSIDES TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) SENNOSIDES 8.6 mg/1 N 20181231 49348-274_9a8897f4-132d-44d4-a3d8-483956e7b84a 49348-274 HUMAN OTC DRUG sunmark double antibiotic Bacitracin zinc and Polymyxin B sulfate OINTMENT TOPICAL 20120321 OTC MONOGRAPH FINAL part333B McKesson BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 49348-279_261fdce9-7005-421a-a3f5-b92a8ff40cb4 49348-279 HUMAN OTC DRUG Sunmark Antifungal Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C McKesson CLOTRIMAZOLE 10 mg/g N 20181231 49348-280_05990ba5-4433-477e-9ab0-d740a13b6479 49348-280 HUMAN OTC DRUG stool softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) DOCUSATE CALCIUM 240 mg/1 N 20181231 49348-301_1d623317-d07d-429a-8f97-8f6b5741ab73 49348-301 HUMAN OTC DRUG sunmark lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120521 ANDA ANDA202319 McKesson LANSOPRAZOLE 15 mg/1 N 20181231 49348-302_60c9732e-32a9-6627-e053-2a91aa0aad94 49348-302 HUMAN OTC DRUG SUNMARK ANTACID MAXIMUM STRENGTH CHERRY aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 20120601 OTC MONOGRAPH FINAL part331 McKesson ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 49348-303_60c9aca8-2b3e-5fdd-e053-2991aa0a19e3 49348-303 HUMAN OTC DRUG ANTACID MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20120601 OTC MONOGRAPH FINAL part331 MCKESSON (SUNMARK) ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 49348-305_60b5c8b1-ca9e-06e8-e053-2a91aa0ae8b5 49348-305 HUMAN OTC DRUG SUNMARK MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20120401 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 49348-306_b6cc4a42-54c0-4fa7-bb4b-e4de842374e3 49348-306 HUMAN OTC DRUG Sunmark Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20030811 ANDA ANDA074661 McKesson NAPROXEN SODIUM 220 mg/1 N 20181231 49348-315_f05b4f9d-f919-4ae4-b10c-7b31af0d7fb1 49348-315 HUMAN OTC DRUG Sunmark cough dm dextromethorphan polistirex SUSPENSION ORAL 20120828 ANDA ANDA091135 McKesson DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 49348-325_04bbd467-19ef-410f-8455-b6315e770482 49348-325 HUMAN OTC DRUG Sunmark pain and fever childrens Acetaminophen SUSPENSION ORAL 20130117 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL N 20181231 49348-326_4e3feada-e5dd-42f1-823e-7fdf4d47c845 49348-326 HUMAN OTC DRUG sunmark Childrens Cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 49348-329_64b62344-7def-43f7-93b3-0e2a0c19008b 49348-329 HUMAN OTC DRUG Sunmark Lubricating Plus carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20130606 OTC MONOGRAPH FINAL part349 McKesson CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM .5 g/100mL N 20181231 49348-333_42c6a214-9cc6-4939-806c-42d8d33cfdcc 49348-333 HUMAN OTC DRUG sunmark Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 McKesson LORATADINE 5 mg/5mL N 20181231 49348-337_bf5b8a27-76f1-4ce0-9891-7f2cf751ed25 49348-337 HUMAN OTC DRUG Sunmark Caldiphen Calamine and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 McKesson ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 49348-354_fe1ff901-7ed2-40aa-94aa-a5fc62a740a2 49348-354 HUMAN OTC DRUG sunmark miconazole 3 Miconazole nitrate KIT 20030905 ANDA ANDA075329 McKesson N 20181231 49348-355_0935591a-6ead-4cfc-aa4e-3a49f1870110 49348-355 HUMAN OTC DRUG sunmark miconazole 3 Miconazole nitrate KIT 20030905 ANDA ANDA075329 McKesson N 20181231 49348-361_63c2388c-fc00-4789-b454-f8b59aa569c1 49348-361 HUMAN OTC DRUG Sunmark Sinus 12 hour Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030624 ANDA ANDA075153 McKesson PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 49348-363_6ce8f2e2-382c-4759-84c9-14643367aa28 49348-363 HUMAN OTC DRUG Motion sickness less drowsy formula Meclizine HCl TABLET ORAL 20100709 OTC MONOGRAPH FINAL part336 McKesson (Sunmark) MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 49348-364_18a65eb2-f8ff-48ea-b3c0-3b74fe81832c 49348-364 HUMAN OTC DRUG Urinary Pain Relief Phenazopyridine Hydrochloride TABLET ORAL 20100709 UNAPPROVED DRUG OTHER Mckesson (Sunmark) PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 49348-374_feadd09a-97bb-462b-a99c-929adc566d8e 49348-374 HUMAN OTC DRUG sunmark ibuprofen infants ibuprofen SUSPENSION ORAL 20030828 ANDA ANDA075217 McKesson IBUPROFEN 50 mg/1.25mL N 20181231 49348-379_72c65af4-b92d-454d-a3e3-ea22020331fc 49348-379 HUMAN OTC DRUG sunmark Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 McKesson CLOTRIMAZOLE 2 g/100g N 20181231 49348-389_66aefab9-b8cd-4498-a7ae-a10c1719e02e 49348-389 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Sunmark CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 49348-393_842c22cf-6e1a-4aae-ad68-e50ef5ee59c1 49348-393 HUMAN OTC DRUG Sunmark Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130815 ANDA ANDA076518 McKesson NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 49348-394_99e74217-d36b-412f-8907-a145c9e2645a 49348-394 HUMAN OTC DRUG SUNMARK LORATADINE Loratadine TABLET ORAL 20140331 ANDA ANDA076301 Mckesson LORATADINE 10 mg/1 N 20181231 49348-398_911b2293-abd6-4d7c-a1ea-6c6121235067 49348-398 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090109 OTC MONOGRAPH FINAL part341 McKesson CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg N 20181231 49348-405_de4f7e5e-4e57-484f-8150-84debabc2588 49348-405 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20130121 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL 70 mL/100mL N 20181231 49348-412_8a64ca81-448d-4400-a913-833d0ab9ad76 49348-412 HUMAN OTC DRUG Sunmark z sleep Diphenhydramine HCl SOLUTION ORAL 20130716 OTC MONOGRAPH FINAL part338 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 49348-413_d9b92ac3-efcf-4826-aa5e-168a64e13c53 49348-413 HUMAN OTC DRUG Sunmark z-sleep Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140131 OTC MONOGRAPH FINAL part338 Mckesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49348-421_f8ac8c1c-31bc-4e97-806f-3a0a0a462915 49348-421 HUMAN OTC DRUG Sunmark Adult Tussin DM Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20130813 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 49348-426_8b7ca96b-11b6-476a-a3c7-7e4e27a323bd 49348-426 HUMAN OTC DRUG Sunmark Muscle Rub Menthol, Methyl salicylate CREAM TOPICAL 20131103 OTC MONOGRAPH NOT FINAL part348 McKesson MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g N 20181231 49348-430_9f206c0b-0eb3-4767-82ce-a233fd702c4a 49348-430 HUMAN OTC DRUG Sunmark Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20110926 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL N 20181231 49348-441_1d0959e7-9d66-4ec2-aa39-6686aec42203 49348-441 HUMAN OTC DRUG sunmark Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 McKesson HYDROCORTISONE 1 g/100g N 20181231 49348-443_28e32dd2-f68b-4eb8-ba99-b560f6413308 49348-443 HUMAN OTC DRUG Sunmark Lice Killing Maximum Strength Lice Treatment Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070727 OTC MONOGRAPH FINAL part358G McKesson PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 49348-459_73c0301c-5ca8-492c-8a25-5016f355b4b6 49348-459 HUMAN OTC DRUG Hygienic Cleansing Pads witch hazel SOLUTION TOPICAL 20030618 OTC MONOGRAPH FINAL part346 McKesson WITCH HAZEL .5 mL/mL E 20171231 49348-471_a69c1165-3b6b-422c-a718-e2fc4b4540d5 49348-471 HUMAN OTC DRUG SunMark Night Time Sleep Aid Diphenhydramine Hydrochloride TABLET ORAL 20030821 OTC MONOGRAPH FINAL part338 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49348-473_7b32dc8d-59e9-4772-8f66-7b22a7b73688 49348-473 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130920 ANDA ANDA201745 Sunmark RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 49348-476_d02e494b-85e0-4617-b4a3-9f8d7140236e 49348-476 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19950825 OTC MONOGRAPH NOT FINAL part356 McKesson EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49348-477_7deb0760-45ea-4aa1-8000-5ad91991a383 49348-477 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20121217 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL 700 mg/mL N 20181231 49348-480_5e3aa435-fd90-481d-a227-5352b8c7602d 49348-480 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Metyl salicylate, Thymol RINSE ORAL 20090519 OTC MONOGRAPH NOT FINAL part356 McKesson EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49348-482_47582d82-533e-4563-83e0-babcfbe12693 49348-482 HUMAN OTC DRUG Antiseptic EUCALYPTOL,MENTHOL, METHYL SALICYLATE, THYMOL RINSE ORAL 19900815 OTC MONOGRAPH NOT FINAL part356 McKesson EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 49348-483_20d58c23-8eda-486d-b3d0-e6dd5a6989d1 49348-483 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130815 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) DOCUSATE SODIUM 100 mg/1 N 20181231 49348-487_4605a235-a22e-40d1-8f6e-00c361e92904 49348-487 HUMAN OTC DRUG sunmark lice solution kit Piperonyl Butoxide, Pyrethrum Extract KIT 20071019 OTC MONOGRAPH FINAL part358G McKesson N 20181231 49348-489_d71d8a53-4bf0-42d5-9040-a5042f2dbf9c 49348-489 HUMAN OTC DRUG gas relief ultra strength Simethicone CAPSULE ORAL 20100709 OTC MONOGRAPH FINAL part332 McKesson (Sunmark) DIMETHICONE 180 mg/1 E 20171231 49348-498_850d330e-87ba-47e4-89b4-76af533545a4 49348-498 HUMAN OTC DRUG Sunmark aspirin adult low strength Aspirin TABLET, CHEWABLE ORAL 20030919 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 N 20181231 49348-499_b5df6851-af20-46b7-9b4b-3340397f01d7 49348-499 HUMAN OTC DRUG Sunmark ibuprofen childrens Ibuprofen SUSPENSION ORAL 20030906 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL N 20181231 49348-500_9624f66a-66e6-4144-8c9f-8a8ee8edcb9c 49348-500 HUMAN OTC DRUG Sunmark ibuprofen childrens Ibuprofen SUSPENSION ORAL 20030624 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL N 20181231 49348-504_9c487a9c-cebe-4925-83f2-91bcbc9fdf73 49348-504 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20020301 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49348-506_db277be3-e188-4a34-8564-c6df34af3d76 49348-506 HUMAN OTC DRUG Sunmark migraine relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20030818 ANDA ANDA075794 McKesson ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 49348-508_3cff64a0-518c-4a50-86e3-7df70cdf2393 49348-508 HUMAN OTC DRUG SUNMARK TIOCONAZOLE 1 Tioconazole OINTMENT VAGINAL 20071218 ANDA ANDA075915 McKesson TIOCONAZOLE 6.5 g/100g N 20181231 49348-509_f99a3bd4-7fe1-4c4e-8532-b29e9ebb2156 49348-509 HUMAN OTC DRUG Sunmark Gas relief Dimethicone TABLET, CHEWABLE ORAL 20040410 OTC MONOGRAPH FINAL part332 McKesson DIMETHICONE 80 mg/1 N 20181231 49348-511_c3ad9e18-4bc2-4f52-b762-36f60c7d6cca 49348-511 HUMAN OTC DRUG Stomach relief Bismuth subsalicylate TABLET ORAL 20110909 OTC MONOGRAPH FINAL part335 McKesson BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 49348-520_0e921767-7cbf-4739-895c-29567fbcb357 49348-520 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H McKesson PYRITHIONE ZINC 10 mg/mL N 20181231 49348-521_f4e86652-6179-4aef-bd2c-179419bf4183 49348-521 HUMAN OTC DRUG Sunmark Hydrocortisone with Aloe Maximum Strength Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 McKesson HYDROCORTISONE 1 g/100g N 20181231 49348-522_7f8d90f1-5da5-4307-bce4-487cc80fe71d 49348-522 HUMAN OTC DRUG sunmark Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 McKesson HYDROCORTISONE 1 g/100g N 20181231 49348-529_1faa923e-5e03-4d4e-87e9-457aa784b044 49348-529 HUMAN OTC DRUG sunmark anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030627 ANDA ANDA075232 McKesson LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 49348-530_e21ebe8d-de66-457e-9362-a132516a239a 49348-530 HUMAN OTC DRUG Sunmark Miconazole 7 Miconazole nitrate CREAM VAGINAL 20030731 ANDA ANDA074760 McKesson MICONAZOLE NITRATE 2 g/100g N 20181231 49348-532_64d14310-f581-4be8-ba67-b27ddc93abdb 49348-532 HUMAN OTC DRUG natural laxative plus stool softener docusate sodium and sennosides TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 49348-541_60d0d9f4-45c6-4861-8423-d5cc7a755144 49348-541 HUMAN OTC DRUG Sunmark fiber laxative Methylcellulose TABLET ORAL 20070102 OTC MONOGRAPH FINAL part334 McKesson METHYLCELLULOSE (4000 CPS) 500 mg/1 N 20181231 49348-543_000c5c1b-d378-4acb-af47-5414dcab8b70 49348-543 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Sunmark LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 49348-544_50737cb7-6884-4960-a0bf-89188bedd322 49348-544 HUMAN OTC DRUG Stool Softener plus stimulant Laxative Docusate sodium and Sennosides TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 49348-559_056ac079-32ec-4558-a8e2-10617b8e39cd 49348-559 HUMAN OTC DRUG Medicated Wipes witch hazel SOLUTION TOPICAL 20030619 OTC MONOGRAPH FINAL part346 McKesson WITCH HAZEL .5 mL/mL E 20171231 49348-568_fe80bf8c-8ba4-43e8-b1ff-60a1bb8cade0 49348-568 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100709 ANDA ANDA078682 Mckesson (Sunmark) IBUPROFEN 200 mg/1 N 20181231 49348-572_15a819d7-b243-4931-ae18-7e92ad05508b 49348-572 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050618 ANDA ANDA076789 McKesson NICOTINE 4 mg/1 N 20181231 49348-573_f478a7b0-cf06-414e-9a02-537b35292242 49348-573 HUMAN OTC DRUG sunmark nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050618 ANDA ANDA076775 McKesson NICOTINE 2 mg/1 N 20181231 49348-574_6225b637-253e-45f8-9ba2-4b81e738ac92 49348-574 HUMAN OTC DRUG Sunmark sleep aid Doxylamine succinate TABLET ORAL 20030815 ANDA ANDA040167 McKesson DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 49348-576_67ab7388-88a6-445e-8692-6b91cf41ec0b 49348-576 HUMAN OTC DRUG sunmark anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20031007 UNAPPROVED DRUG OTHER Mckesson DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 49348-577_44bfb19c-57f6-46cc-b9b9-9b007dab6722 49348-577 HUMAN OTC DRUG Sunmark infants gas relief drops Simethicone EMULSION ORAL 20031031 OTC MONOGRAPH FINAL part332 McKesson DIMETHICONE 20 mg/.3mL N 20181231 49348-598_82c6ecbf-31e4-4029-9d12-1342b602f99c 49348-598 HUMAN OTC DRUG Bisacodyl Laxative bisacodyl SUPPOSITORY RECTAL 20050808 OTC MONOGRAPH FINAL part334 McKesson BISACODYL 10 mg/1 E 20171231 49348-599_93b9892a-eb53-45d1-9e30-cb99485c998e 49348-599 HUMAN OTC DRUG Gentle Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20130110 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) BISACODYL 5 mg/1 N 20181231 49348-600_78121745-fe0c-4277-9e1f-520beb179c78 49348-600 HUMAN OTC DRUG sunmark triple antibiotic plus pain relief polymyxin B sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B McKesson BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 49348-602_4bd8eeb3-3eaa-4dba-a2eb-d91a799be582 49348-602 HUMAN OTC DRUG Anti-Dandruff Coal Tar SHAMPOO TOPICAL 20050521 OTC MONOGRAPH FINAL part358H McKesson COAL TAR 25.25 mg/mL N 20191231 49348-603_51c2bd90-0725-4186-8821-2e504deeeebb 49348-603 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE RINSE ORAL 20010817 OTC MONOGRAPH FINAL part355 McKesson SODIUM FLUORIDE .05 kg/100L N 20181231 49348-610_602ca10d-48cf-c90c-e053-2991aa0a3850 49348-610 HUMAN OTC DRUG Sunmark Caldyphen Clear Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 McKesson ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 49348-622_abbac463-435c-4dc2-9623-6cc1dc3a6339 49348-622 HUMAN OTC DRUG sunmark Povidone-Iodine Topical POVIDONE-IODINE SOLUTION TOPICAL 20120628 OTC MONOGRAPH FINAL part333A McKesson POVIDONE-IODINE 100 mg/mL N 20181231 49348-632_98d0f85c-b530-46b9-bd32-4becd65eebbe 49348-632 HUMAN OTC DRUG Sunmark smooth antacid Calcium carbonate TABLET, CHEWABLE ORAL 20040426 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 750 mg/1 N 20181231 49348-633_ce441faa-49d4-45fb-a13d-ea6396db77c8 49348-633 HUMAN OTC DRUG Fiber laxative Psyllium husk CAPSULE ORAL 20031114 OTC MONOGRAPH NOT FINAL part334 McKesson PSYLLIUM HUSK 520 mg/1 N 20181231 49348-636_285e79a3-f79a-42e3-8462-ccbbe6f6ea65 49348-636 HUMAN OTC DRUG Sunmark childrens loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 McKesson LORATADINE 5 mg/5mL N 20181231 49348-639_107a79ca-1917-48d2-9e7d-b87ab4bade17 49348-639 HUMAN OTC DRUG Sunmark Ibuprofen IB Ibuprofen TABLET, CHEWABLE ORAL 20040710 ANDA ANDA076359 McKesson IBUPROFEN 100 mg/1 N 20181231 49348-642_734e2926-a090-4c7a-8f66-327392b30f9b 49348-642 HUMAN OTC DRUG sunmark ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20040429 ANDA ANDA075217 McKesson IBUPROFEN 50 mg/1.25mL N 20181231 49348-645_92f79e18-6593-4dbf-8613-6497789f9865 49348-645 HUMAN OTC DRUG sunmark miconazole 3 Miconazole nitrate KIT 20040720 ANDA ANDA076357 McKesson N 20181231 49348-686_539e2c02-b258-45ea-8694-58ce5165ea7c 49348-686 HUMAN OTC DRUG SUNMARK 12 HOUR ALLERGY RELIEF Clemastine fumarate TABLET ORAL 20030703 ANDA ANDA074512 McKesson CLEMASTINE FUMARATE 1.34 mg/1 N 20181231 49348-689_c76dad76-41a3-4417-a734-f45c61ba1391 49348-689 HUMAN OTC DRUG SUNMARK MICONAZOLE NITRATE antifungal Miconazole Nitrate CREAM TOPICAL 19911001 OTC MONOGRAPH FINAL part333C McKesson MICONAZOLE NITRATE 20 mg/g N 20181231 49348-690_a85c4659-1d93-4c17-80be-6d613c8fc69a 49348-690 HUMAN OTC DRUG sunmark antibiotic plus pain relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B McKesson NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 49348-691_9574a3ea-6b46-4943-bb95-d853050b218c 49348-691 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050623 ANDA ANDA078325 McKesson NICOTINE 2 mg/1 N 20181231 49348-692_da607012-e5ed-4c75-b207-b1da6723c804 49348-692 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050623 ANDA ANDA078326 McKesson NICOTINE 4 mg/1 N 20181231 49348-696_2da588a0-d07c-4d22-ab3b-c21dc1874c8e 49348-696 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20120320 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49348-697_c07d59b4-b416-49a2-8e49-3346b37cf6b9 49348-697 HUMAN OTC DRUG Sunmark Eye Drops Advanced Moisturizer/Lubricant Dextran, Polyethylene glycol, Povidone, Tetrahydrozoline LIQUID OPHTHALMIC 20070301 OTC MONOGRAPH FINAL part349 McKesson Corporation DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .1; 1; 1; .05 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 49348-700_623fc7da-54aa-4317-a4a5-2c9a07e2b479 49348-700 HUMAN OTC DRUG sunmark nasal decongestant pe maximum strength Phenylephrine Hydrochloride TABLET ORAL 20050214 OTC MONOGRAPH FINAL part341 McKesson PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 49348-706_1eee03cb-d8ca-413e-ab42-aed41b5fdd24 49348-706 HUMAN OTC DRUG sunmark ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20030624 ANDA ANDA072096 McKesson IBUPROFEN 200 mg/1 N 20181231 49348-709_73b0825f-fe9b-43fb-b1ed-7ce95b33e0e0 49348-709 HUMAN OTC DRUG pain reliever extra strength Acetaminophen CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH NOT FINAL part343 Mckesson (Sunmark) ACETAMINOPHEN 500 mg/1 N 20181231 49348-711_602d29e1-c83b-d8c5-e053-2a91aa0ae7fd 49348-711 HUMAN OTC DRUG Sunmark Iodides Tincture Ethyl Alcohol LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL .45 mL/mL N 20181231 49348-714_49cdb4b9-d20c-49ab-8348-fb4b373253ca 49348-714 HUMAN OTC DRUG STOOL SOFTENER EXTRA STRENGTH DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) DOCUSATE SODIUM 250 mg/1 N 20181231 49348-727_fbb21f97-a506-4282-a403-1fa836c749e1 49348-727 HUMAN OTC DRUG sunmark ibuprofen ib Ibuprofen TABLET, FILM COATED ORAL 20060428 ANDA ANDA077349 McKesson IBUPROFEN 200 mg/1 N 20181231 49348-728_909de6c3-2371-47e5-927d-20afc57e89a0 49348-728 HUMAN OTC DRUG Sunmark Chest Congestion Relief DM DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 49348-729_3f6499ed-2286-461a-8532-3577f5165ba9 49348-729 HUMAN OTC DRUG Chest Congestion Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Mckesson GUAIFENESIN 400 mg/1 N 20181231 49348-730_8cfcf60c-3465-4961-b7ed-bced476cdbe5 49348-730 HUMAN OTC DRUG Sunmark Pain Reliever Acetaminophen TABLET, COATED ORAL 20051227 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 N 20181231 49348-737_60734161-ec9b-49bd-bf56-577a3d00630c 49348-737 HUMAN OTC DRUG SUNMARK TUSSIN CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060502 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 49348-738_1abb2c29-b55b-43b2-8aea-f26182ee6cf6 49348-738 HUMAN OTC DRUG Day Time PE cold and flu relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20100709 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 49348-740_1e9f8701-44c2-40dc-aee5-c5f5f3210595 49348-740 HUMAN OTC DRUG gas relief drops infants simethicone EMULSION ORAL 20121201 OTC MONOGRAPH FINAL part332 Mckesson DIMETHICONE 20 mg/.3mL N 20181231 49348-741_57db4fbe-5121-4d7d-be68-12b20e0c0fd6 49348-741 HUMAN OTC DRUG Nite time cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120718 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 49348-743_709fd6a0-4485-443d-a6b4-f5dc4ddadfd3 49348-743 HUMAN OTC DRUG McKesson Nite Time acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090709 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 49348-752_d2f9ece0-36f9-4271-9e35-1b2ef9d2697d 49348-752 HUMAN OTC DRUG Anti-Diarrheal loperamide HCl LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20060801 NDA NDA021855 McKesson (Sunmark) LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 49348-753_78841fd6-c4d2-41ef-a2d6-886740fb6049 49348-753 HUMAN OTC DRUG Sunmark Day time cold and flu acetaminophen, dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20060609 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 49348-757_bd0f0376-0a8f-4b47-94f7-01d0590a1b53 49348-757 HUMAN OTC DRUG Sunmark Aspirin Aspirin TABLET, CHEWABLE ORAL 20030821 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 N 20181231 49348-759_3b0b735c-59e0-40f2-a574-e92cebeb6a15 49348-759 HUMAN OTC DRUG Sunmark fiber laxative Calcium polycarbophil TABLET, FILM COATED ORAL 20030922 OTC MONOGRAPH NOT FINAL part334 McKesson CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 49348-771_0957762a-59e3-46b1-b2b9-02aa12360a38 49348-771 HUMAN OTC DRUG Sunmark stay awake Caffeine TABLET ORAL 20030821 OTC MONOGRAPH FINAL part340 McKesson CAFFEINE 200 mg/1 N 20181231 49348-774_e2c69896-9616-45ad-904a-318909928664 49348-774 HUMAN OTC DRUG Sunmark Chest Congestion Relief PE PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Mckesson Corporation GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 49348-775_8e6b5f06-42e3-4340-8ecd-24189f9300e4 49348-775 HUMAN OTC DRUG SUNMARK COLD AND COUGH DM CHILDRENS Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20060911 OTC MONOGRAPH FINAL part341 McKesson BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 49348-777_941c2e89-ecc4-4e24-ab9f-b917896b39fd 49348-777 HUMAN OTC DRUG Sunmark Cold and Allergy Childrens phenylephrine hcl, brompheniramine maleate SOLUTION ORAL 20060911 OTC MONOGRAPH FINAL part341 McKesson PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 49348-778_ef414c05-e257-4e5e-8d4e-77b91d35c666 49348-778 HUMAN OTC DRUG sunmark allergy multi symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20051206 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 49348-787_28582c2d-467f-4e6e-a7c7-7689a5f4ad58 49348-787 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061221 ANDA ANDA076777 McKesson NICOTINE 2 mg/1 N 20181231 49348-788_f6018208-549d-4d26-814d-6a137ee92be5 49348-788 HUMAN OTC DRUG Sunmark Nicotine Nicotine GUM, CHEWING ORAL 20061221 ANDA ANDA076779 McKesson NICOTINE 4 mg/1 N 20181231 49348-790_5ffb32df-6b19-436e-ac92-0a0ab5b6f550 49348-790 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 McKesson TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 49348-793_648a75e0-169f-4510-9001-ab66cc2a3283 49348-793 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 19930719 ANDA ANDA074165 McKesson CLOTRIMAZOLE 10 mg/g N 20181231 49348-801_d906e423-1437-4198-884a-5b31752a6381 49348-801 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 McKesson MENTHOL 1.5 mg/g N 20181231 49348-802_602cb0ae-4354-7ac2-e053-2a91aa0a60b6 49348-802 HUMAN OTC DRUG Sunmark Phenolated Calamine Calamine and Zinc Oxide and Phenol LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 McKesson ZINC OXIDE; PHENOL 160; 10 mg/mL; mg/mL N 20181231 49348-811_33943cff-4aa0-43c0-8787-a08130b8a4d0 49348-811 HUMAN OTC DRUG Hemorrhoidal Cooling Gel phenylephrine and witch hazel GEL TOPICAL 20061115 OTC MONOGRAPH FINAL part346 McKesson PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/g; g/g E 20171231 49348-813_ec1985ab-a2c5-433b-9acc-de7a3cdb0365 49348-813 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20061128 OTC MONOGRAPH NOT FINAL part333A McKesson BENZALKONIUM CHLORIDE .13 mL/mL E 20171231 49348-817_3b49e035-57b7-488f-a1dd-137dcccae876 49348-817 HUMAN OTC DRUG SunMark Acid Reducer maximum strength Famotidine TABLET ORAL 20070618 ANDA ANDA077351 McKesson FAMOTIDINE 20 mg/1 N 20181231 49348-818_d51883ce-73e9-4d89-ba9b-0fd0c5b548fd 49348-818 HUMAN OTC DRUG Sunmark Loratadine Loratadine TABLET ORAL 20070621 ANDA ANDA076301 McKesson LORATADINE 10 mg/1 N 20181231 49348-828_f3d929ee-6fd4-4d84-906a-0c16127c87bc 49348-828 HUMAN OTC DRUG Sun Mark Mucus Relief Cough Childrens Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 20071012 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 49348-831_02b1b982-82b0-4bbc-b845-5273ac1b53e2 49348-831 HUMAN OTC DRUG Sunmark Mineral OIL ORAL 20021113 OTC MONOGRAPH NOT FINAL part334 McKesson MINERAL OIL 999 mg/mL N 20181231 49348-833_d3ab3e08-420f-4e7a-a18d-4f89a8e70d18 49348-833 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate SUPPOSITORY VAGINAL 20111209 ANDA ANDA073507 McKesson MICONAZOLE NITRATE 100 mg/1 N 20181231 49348-834_af235554-f943-4e69-9557-6880cc6168f7 49348-834 HUMAN OTC DRUG Medicated Body MENTHOL, ZINC OXIDE POWDER TOPICAL 19940618 OTC MONOGRAPH NOT FINAL part348 McKesson MENTHOL; ZINC OXIDE .15; 1 g/100kg; g/100kg N 20181231 49348-839_e33151fd-14ef-4fc6-be7f-67dd513d4b5d 49348-839 HUMAN OTC DRUG Glycerin Glycerin LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part347 McKesson GLYCERIN 995 mg/mL N 20181231 49348-846_f4ac4cee-d3fa-4997-822b-b24dc562ed06 49348-846 HUMAN OTC DRUG sunmark omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080226 NDA NDA022032 McKesson OMEPRAZOLE 20 mg/1 N 20181231 49348-849_492e6c04-e1a4-41a4-9090-bfe010609c90 49348-849 HUMAN OTC DRUG Sunmark childrens loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 McKesson LORATADINE 5 mg/5mL N 20181231 49348-851_0cabdccd-5d24-40fe-a004-5ad4b5379718 49348-851 HUMAN OTC DRUG Sunmark All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080418 ANDA ANDA077170 McKesson CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 49348-852_bfc83396-13f1-4b64-b65c-20c032c18dc6 49348-852 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex LOZENGE ORAL 20080507 ANDA ANDA077007 McKesson NICOTINE 2 mg/1 N 20181231 49348-853_651556ac-1b17-41f0-b69f-26ede58fb44b 49348-853 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex LOZENGE ORAL 20080430 ANDA ANDA077007 McKesson NICOTINE 4 mg/1 N 20181231 49348-854_5d4a1e9f-ce43-47ce-8fa8-52a45bdb3b46 49348-854 HUMAN OTC DRUG sunmark anti-itch diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH FINAL part348 McKesson DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 49348-861_21574cd7-db75-47b2-ac9e-26ad27f72334 49348-861 HUMAN OTC DRUG sunmark tussin dm sugar free Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20030624 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 49348-863_fff9a801-cc0f-424b-b237-6ecf84833bd7 49348-863 HUMAN OTC DRUG gas relief simethicone TABLET, CHEWABLE ORAL 20121001 OTC MONOGRAPH FINAL part332 Mckesson DIMETHICONE 125 mg/1 N 20181231 49348-864_41243323-23ac-40c1-b87b-65f8fcfdab4f 49348-864 HUMAN OTC DRUG Sunmark Saline Laxative ENEMA RECTAL 20130306 OTC MONOGRAPH NOT FINAL part334 Mckesson Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 49348-872_0d8fad72-55d4-460b-9b76-91f2f62f1579 49348-872 HUMAN OTC DRUG sunmark miconazole 7 Miconazole nitrate CREAM VAGINAL 20031125 ANDA ANDA074760 McKesson MICONAZOLE NITRATE 2 g/100g N 20181231 49348-873_d3cdd5fc-d793-402b-86f8-72918547d34d 49348-873 HUMAN OTC DRUG sunmark ibuprofen pm diphenhydramine citrate and ibuprofen TABLET, FILM COATED ORAL 20090218 ANDA ANDA079113 McKesson DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 49348-876_2282d7b9-6264-48d9-a23b-dfebd8172a68 49348-876 HUMAN OTC DRUG Sunmark ibuprofen childrens Ibuprofen SUSPENSION ORAL 20090401 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL N 20181231 49348-880_925963ca-3b24-4400-9650-839358e8ada7 49348-880 HUMAN OTC DRUG Sunmark Mineral Oil Mineral Oil ENEMA RECTAL 20130801 OTC MONOGRAPH NOT FINAL part334 Mckesson Corporation MINERAL OIL 118 mL/118mL E 20171231 49348-883_afc09b45-3a66-4edd-bcc5-28b47fa6a10e 49348-883 HUMAN OTC DRUG sunmark arthricream rub Trolamine Salicylate CREAM TOPICAL 20090610 OTC MONOGRAPH NOT FINAL part348 McKesson TROLAMINE SALICYLATE 10 g/100g N 20181231 49348-890_c29cd973-f3ab-45f3-837c-afd4738782fc 49348-890 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20061206 OTC MONOGRAPH FINAL part358H McKesson PYRITHIONE ZINC 1 g/100mL N 20181231 49348-893_e90b00be-b4f9-4262-9a58-61451014a2c1 49348-893 HUMAN OTC DRUG sunmark clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 McKesson POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 49348-894_117ea02b-a6ac-4bf4-bb54-52489b58dbc4 49348-894 HUMAN OTC DRUG Sunmark Redness Relief Glycerin, Naphazoline hydrochloride LIQUID OPHTHALMIC 20091001 OTC MONOGRAPH FINAL part349 McKesson Corporation GLYCERIN; NAPHAZOLINE HYDROCHLORIDE .2; .012 g/100mL; g/100mL N 20181231 49348-896_adfcf5ae-e6f1-4707-bbf1-2cbb90a026e3 49348-896 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333A McKesson Corporation ISOPROPYL ALCOHOL .7 mL/1 N 20181231 49348-897_6c17c3de-00b9-4f92-aa3e-ec48fc7220db 49348-897 HUMAN OTC DRUG Alcohol Prep Pads with Pain Relief benzocaine SWAB TOPICAL 20100219 OTC MONOGRAPH NOT FINAL part348 McKesson BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 E 20171231 49348-917_4f0877a3-431e-4fd2-b006-c232cc5ca3a2 49348-917 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE ORAL 20100824 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) DOCUSATE SODIUM 100 mg/1 N 20181231 49348-920_6220eb74-1c4f-4e22-9887-70da296c24cd 49348-920 HUMAN OTC DRUG womans laxative Bisacodyl TABLET ORAL 20100709 OTC MONOGRAPH NOT FINAL part334 Mckesson (Sunmark) BISACODYL 5 mg/1 N 20181231 49348-921_ebc79b1d-d574-43e1-80f8-86bb904bdd8a 49348-921 HUMAN OTC DRUG Sunmark Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Sunmark ACETAMINOPHEN 650 mg/1 N 20181231 49348-922_1e48129f-b871-4670-b040-590a0689f11b 49348-922 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20150131 OTC MONOGRAPH FINAL part335 McKesson (Sunmark) BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 49348-923_c1399ce3-df38-42ce-bb09-4c37714ab5c6 49348-923 HUMAN OTC DRUG Stomach Relief Maximum Strength Maximum Strength Pepto Bismol SUSPENSION ORAL 20131108 OTC MONOGRAPH FINAL part335 McKesson (Sunmark) BISMUTH SUBSALICYLATE 525 mg/15mL N 20181231 49348-924_579c5e78-3a1a-4b93-b1ad-3d71d83c91f7 49348-924 HUMAN OTC DRUG Sunmark Arthritis 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Sunmark ACETAMINOPHEN 650 mg/1 N 20181231 49348-927_d1345cd6-c22d-42a0-b301-cc004df94ec3 49348-927 HUMAN OTC DRUG Sunmark ibuprofen ib Ibuprofen TABLET, COATED ORAL 20060320 ANDA ANDA077349 McKesson IBUPROFEN 200 mg/1 N 20181231 49348-929_e1e28a49-a526-42b0-8a64-c3546094962f 49348-929 HUMAN OTC DRUG Sunmark Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Sunmark LORATADINE 10 mg/1 N 20181231 49348-930_e1e28a49-a526-42b0-8a64-c3546094962f 49348-930 HUMAN OTC DRUG Sunmark Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Sunmark LORATADINE 10 mg/1 N 20181231 49348-934_c3bda682-3a3e-4874-911f-a4c0b6cb6c36 49348-934 HUMAN OTC DRUG sunmark childrens all day allergy cetirizine Hydrochloride SOLUTION ORAL 20100909 ANDA ANDA090254 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 49348-937_777bb87f-ecde-444b-b361-52b1fca524f2 49348-937 HUMAN OTC DRUG Enteric coated aspirin Regular strength Aspirin TABLET, COATED ORAL 20100915 OTC MONOGRAPH FINAL part343 McKesson (Sunmark) ASPIRIN 325 mg/1 N 20181231 49348-939_3c2dd452-9a10-416c-91e6-170ba0723fed 49348-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20110801 ANDA ANDA078862 McKesson CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 49348-940_4020b635-77f1-4807-82c7-d1066dec1e7b 49348-940 HUMAN OTC DRUG Sunmark Naproxen Sodium Naproxen sodium CAPSULE, LIQUID FILLED ORAL 20101207 NDA NDA021920 McKesson NAPROXEN SODIUM 220 mg/1 N 20181231 49348-941_e10aebb7-5190-476c-822e-5669a3296491 49348-941 HUMAN OTC DRUG Sunmark Urinary Pain Relief Maximum Strength PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20101118 UNAPPROVED DRUG OTHER McKesson PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 49348-946_f986195f-5b08-4c10-bab6-44fd7855653e 49348-946 HUMAN OTC DRUG Gas Relief Extra strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20110412 OTC MONOGRAPH FINAL part347 McKesson (Sunmark) DIMETHICONE 125 mg/1 E 20171231 49348-947_9297b3f0-c2ed-4eaa-ae6c-9f551d753598 49348-947 HUMAN OTC DRUG Sunmark Lubricant Eye Drops Polypropylene glycol 400, Propylene glycol LIQUID OPHTHALMIC 20101201 OTC MONOGRAPH FINAL part349 McKesson Corporation POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL N 20181231 49348-953_01f2e040-5701-430c-a03c-e5b8ec71f207 49348-953 HUMAN OTC DRUG Sunmark Stomach relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20110301 OTC MONOGRAPH FINAL part335 McKesson BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 49348-954_5599b10c-3620-4cf5-977e-579d73c38d04 49348-954 HUMAN OTC DRUG Calcium antacid Calcium antacid TABLET, CHEWABLE ORAL 20110407 OTC MONOGRAPH FINAL part331 Sunmark CALCIUM CARBONATE 750 mg/1 N 20181231 49348-955_7d0a075f-452e-4cff-9076-39b42fc85d22 49348-955 HUMAN OTC DRUG Sunmark Assorted Berries calcium carbonate TABLET, CHEWABLE ORAL 20101010 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 750 mg/1 N 20181231 49348-956_8b7bfcc8-5e6b-49c6-93e2-bd7666c41d93 49348-956 HUMAN OTC DRUG Sunmark Tropical fruit Calcium antacid TABLET, CHEWABLE ORAL 20101010 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 750 mg/1 N 20181231 49348-957_4ef36e62-0078-4ee1-858f-95d04f77229c 49348-957 HUMAN OTC DRUG calcium antacid calcium antacid TABLET, CHEWABLE ORAL 20110305 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 500 mg/1 N 20181231 49348-958_af38c50a-0f5d-4893-ab0d-b17a9b2ae474 49348-958 HUMAN OTC DRUG Sunmark calcium antacid calcium carbonate TABLET, CHEWABLE ORAL 20110401 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 500 mg/1 N 20181231 49348-959_1e5cc1e2-6fde-4e2e-9808-f4364497b770 49348-959 HUMAN OTC DRUG Sunmark Assorted fruit Calcium Antacid TABLET, CHEWABLE ORAL 20110404 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 1000 mg/1 N 20181231 49348-960_ebd958f3-8205-430e-9f2b-a67e5ffa4995 49348-960 HUMAN OTC DRUG Earwax Removal Aid Earwax Removal Aid LIQUID AURICULAR (OTIC) 20110124 OTC MONOGRAPH FINAL part344 McKesson CARBAMIDE PEROXIDE 6.5 mg/100mL E 20171231 49348-968_c1170b59-d1ba-4662-8d7e-e3babd64ed61 49348-968 HUMAN OTC DRUG sunmark fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 McKesson FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 49348-971_9b22a344-24cd-4d4f-968c-073c07b727ee 49348-971 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 20110826 OTC MONOGRAPH FINAL part336 Mckesson (Sunmark) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49348-972_fa33ef6f-3f62-4ff7-a6e8-ef431f4f209d 49348-972 HUMAN OTC DRUG Childrens all day allergy Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 49348-973_5956201e-9c4f-605d-e053-2991aa0ad790 49348-973 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 325 mg/1 N 20181231 49348-974_9b218a04-28ba-443f-a522-86c25a803cfa 49348-974 HUMAN OTC DRUG Isopropyl Alcohol with Benzocaine Isopropyl Alcohol, Benzocaine SWAB TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part348 McKesson Corporation ISOPROPYL ALCOHOL; BENZOCAINE .7; .06 mL/mL; mL/mL N 20181231 49348-975_44d1ed75-8880-4e0e-ac13-cf30694c5f66 49348-975 HUMAN OTC DRUG sunmark nite time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20111121 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 49348-980_8bbbf339-e159-4a6b-8090-9dfd685d2976 49348-980 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 N 20181231 49348-981_9c1ce649-8e4b-4bfc-9bc5-cecd9a015d3b 49348-981 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 N 20181231 49348-982_e1d0d46a-d74f-49da-b12e-ec2cb4fc958f 49348-982 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20110802 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL 65 mL/100L N 20181231 49348-983_541b6894-84d9-4182-84f2-a65bce63fcf4 49348-983 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl TABLET ORAL 20110928 OTC MONOGRAPH FINAL part336 Mckesson (Sunmark) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49348-984_05657d14-ba53-4412-b69f-382a32de3f47 49348-984 HUMAN OTC DRUG All Day Allergy Relief 24 hour Cetirizine HCl TABLET ORAL 20130315 ANDA ANDA078780 McKesson (Sunmark) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 49348-985_bb339ab4-5255-4a08-af7d-132e5c3b4231 49348-985 HUMAN OTC DRUG Sinus and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20111207 OTC MONOGRAPH FINAL part341 Mckesson (Sunmark) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 49348-986_4922086c-6270-4248-e054-00144ff8d46c 49348-986 HUMAN OTC DRUG sugar free cherry cough drops menthol LOZENGE ORAL 20130310 OTC MONOGRAPH FINAL part341 McKesson MENTHOL 5.8 mg/1 N 20181231 49348-987_4921b160-1db2-1696-e054-00144ff88e88 49348-987 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20130310 OTC MONOGRAPH FINAL part341 McKesson MENTHOL 5.8 mg/1 N 20181231 49348-988_4921e9e6-5b23-1dc2-e054-00144ff88e88 49348-988 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20130310 OTC MONOGRAPH FINAL part341 McKesson MENTHOL 7.5 mg/1 N 20181231 49348-990_4921dcac-b9cd-39bb-e054-00144ff8d46c 49348-990 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20130310 OTC MONOGRAPH FINAL part341 McKesson MENTHOL 5.4 mg/1 N 20181231 49348-991_264eb6f0-9fa5-4e2e-845a-7ef237af2b1b 49348-991 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140930 OTC MONOGRAPH NOT FINAL part356 McKesson (Sunmark) PHENOL 1.4 g/100mL N 20181231 49348-992_9a541106-70d3-4691-a8a8-9955db5196b1 49348-992 HUMAN OTC DRUG Anti-Itch Diphenhydramine HCL, Zinc Acetate SPRAY TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part348 McKesson DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 18; .882 mg/mL; mg/mL N 20181231 49348-998_af01d992-7930-44e7-9bb9-d0a54785841f 49348-998 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 N 20181231 49348-999_075bf2ac-1d2c-4306-9c6a-64077d2a12dc 49348-999 HUMAN OTC DRUG sunmark loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20140218 ANDA ANDA091292 McKesson LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 49349-000_0d4423d4-8764-489e-aee7-f2af160e3b60 49349-000 HUMAN PRESCRIPTION DRUG AFEDITAB CR NIFEDIPINE TABLET, EXTENDED RELEASE ORAL 20100513 NDA NDA123456 RemedyRepack NIFEDIPINE 60 mg/60mg Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 49349-101_53be8900-a479-6140-e054-00144ff8d46c 49349-101 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170707 ANDA ANDA077567 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49349-117_3e6f1911-e52c-0a70-e054-00144ff8d46c 49349-117 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20090902 ANDA ANDA070791 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 49349-119_5990dfd1-f8b7-84bf-e053-2a91aa0a8b93 49349-119 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090915 NDA NDA018832 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 49349-139_53bf4c52-85fd-084e-e054-00144ff88e88 49349-139 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20170707 ANDA ANDA078597 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49349-140_3e70e5af-49bd-49a4-e054-00144ff88e88 49349-140 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20090916 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 49349-154_540fae2b-2507-63b1-e054-00144ff8d46c 49349-154 HUMAN PRESCRIPTION DRUG Amiodarone hydrochloride Amiodarone hydrochloride TABLET ORAL 20170711 ANDA ANDA079029 REMEDYREPACK INC. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 49349-156_36e4c5eb-d330-6996-e054-00144ff88e88 49349-156 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20090917 ANDA ANDA076832 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 49349-161_53a6c4c7-50bc-5639-e054-00144ff8d46c 49349-161 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20100113 NDA NDA018877 REMEDYREPACK INC. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 49349-163_3d9951c7-1030-5706-e054-00144ff8d46c 49349-163 HUMAN OTC DRUG Aspirin NSAID Aspirin TABLET ORAL 20090924 OTC MONOGRAPH NOT FINAL part343 REMEDYREPACK INC. ASPIRIN 325 mg/1 E 20171231 49349-175_3e87d5f3-17dd-1572-e054-00144ff88e88 49349-175 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20091230 ANDA ANDA074388 REMEDYREPACK INC. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 49349-189_3d42beb6-531b-646b-e054-00144ff88e88 49349-189 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride fluphenazine hydrochloride TABLET, FILM COATED ORAL 20091030 ANDA ANDA089804 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 49349-207_3eacc3aa-19e1-41fb-e054-00144ff88e88 49349-207 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20091013 ANDA ANDA081049 REMEDYREPACK INC. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 49349-218_40edf56f-dd24-41e0-8002-986e2fd1e0a5 49349-218 HUMAN PRESCRIPTION DRUG Loratadineantihistamine antihistamine Loratadine TABLET ORAL 20130520 ANDA ANDA076301 REMEDYREPACK INC. LORATADINE 10 mg/1 N 20181231 49349-229_540fc836-1cdf-3303-e054-00144ff88e88 49349-229 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20170711 ANDA ANDA086242 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 49349-236_86aa067a-7407-4296-ae07-f0c20fd4b9e7 49349-236 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20110505 ANDA ANDA079088 REMEDYREPACK INC. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 49349-242_4d9bae52-26b1-3b21-e054-00144ff88e88 49349-242 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20091119 ANDA ANDA072838 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 49349-248_3ec1db8a-9cf9-3347-e054-00144ff88e88 49349-248 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20091201 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 49349-261_3f0e93de-853a-4178-e054-00144ff8d46c 49349-261 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET ORAL 20091209 ANDA ANDA078069 REMEDYREPACK INC. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 49349-271_549b295b-217d-1f4a-e054-00144ff88e88 49349-271 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20170718 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 49349-289_549b400b-91e2-26d1-e054-00144ff88e88 49349-289 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20170718 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 49349-305_549b7c13-55fd-512d-e054-00144ff8d46c 49349-305 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20170718 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49349-308_549bc21c-6c9d-37f3-e054-00144ff88e88 49349-308 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20170718 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49349-310_3cf591cc-6be4-4bbc-e054-00144ff8d46c 49349-310 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20100128 ANDA ANDA073556 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 49349-319_549c8694-a323-11aa-e054-00144ff8d46c 49349-319 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20170718 ANDA ANDA074869 REMEDYREPACK INC. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49349-346_55a84b30-042a-5f5c-e054-00144ff8d46c 49349-346 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20100322 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 49349-353_3f4b44bd-aabe-110f-e054-00144ff8d46c 49349-353 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20100325 ANDA ANDA065136 REMEDYREPACK INC. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 49349-358_3f9f55f2-bd4c-42d3-e054-00144ff88e88 49349-358 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100330 ANDA ANDA040625 REMEDYREPACK INC. FOLIC ACID 1 mg/1 E 20171231 49349-386_3cde2bf8-60bf-5c47-e054-00144ff8d46c 49349-386 HUMAN OTC DRUG Enteric Coated Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20100423 OTC MONOGRAPH FINAL part343 REMEDYREPACK INC. ASPIRIN 325 mg/1 E 20171231 49349-418_5037eddb-ec18-5956-e054-00144ff88e88 49349-418 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET, FILM COATED ORAL 20100608 OTC MONOGRAPH NOT FINAL part343 REMEDYREPACK INC. ACETAMINOPHEN 500 mg/1 N 20181231 49349-500_476a7e4c-8cc1-13a0-e054-00144ff88e88 49349-500 HUMAN PRESCRIPTION DRUG Fluphenazine hydrochloride Fluphenazine hydrochloride TABLET, FILM COATED ORAL 20170127 ANDA ANDA089804 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 49349-505_407eaff3-5d2b-5500-e054-00144ff8d46c 49349-505 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20100810 ANDA ANDA073554 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 49349-511_55b8913b-47a4-453b-e054-00144ff88e88 49349-511 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET ORAL 20100812 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. GUAIFENESIN 200 mg/1 N 20181231 49349-512_40b5f72c-5f63-5096-e054-00144ff8d46c 49349-512 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20100812 ANDA ANDA077580 REMEDYREPACK INC. HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] E 20171231 49349-575_3e38d49e-cc70-2365-e054-00144ff8d46c 49349-575 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20100917 ANDA ANDA075483 REMEDYREPACK INC. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 49349-576_518d8415-38a2-492a-e054-00144ff8d46c 49349-576 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 20160414 ANDA ANDA077066 REMEDYREPACK INC. NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 49349-591_4284b85c-c426-4c93-e054-00144ff8d46c 49349-591 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20101027 ANDA ANDA070278 REMEDYREPACK INC. HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] E 20171231 49349-598_428748a1-b74a-5801-e054-00144ff8d46c 49349-598 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20100930 ANDA ANDA089586 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 49349-612_4bfdbcb4-ab48-4a25-963d-b7955b2eede9 49349-612 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20110315 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 49349-612_9ed37a42-ec21-4de3-9bcc-f1d3817482e1 49349-612 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20110524 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 49349-614_55b966d2-dfb6-56ed-e054-00144ff88e88 49349-614 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20101012 ANDA ANDA077802 REMEDYREPACK INC. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 49349-618_4b56a930-2b32-0261-e054-00144ff88e88 49349-618 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20101115 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 49349-631_4b78872f-66ee-31a1-e054-00144ff88e88 49349-631 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 20101215 ANDA ANDA071093 REMEDYREPACK INC. THIOTHIXENE 2 mg/1 Typical Antipsychotic [EPC] N 20181231 49349-644_48354621-2930-0e35-e054-00144ff88e88 49349-644 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20110103 ANDA ANDA086242 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 49349-659_55b9ece5-e9aa-532d-e054-00144ff8d46c 49349-659 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 20110110 ANDA ANDA040254 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 N 20181231 49349-668_3d9c651c-2db8-0df9-e054-00144ff8d46c 49349-668 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20110127 ANDA ANDA074556 REMEDYREPACK INC. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 49349-691_41ee9931-34b5-5a69-e054-00144ff8d46c 49349-691 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20110314 ANDA ANDA076691 REMEDYREPACK INC. LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] E 20171231 49349-701_d9d63875-a435-479f-ae39-e83ad7462d93 49349-701 HUMAN PRESCRIPTION DRUG Epzicom Abacavir Sulfate and Lamivudine TABLET, FILM COATED ORAL 20110912 NDA NDA021652 REMEDYREPACK INC. ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 49349-716_417468df-5373-484b-e054-00144ff88e88 49349-716 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20110503 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 49349-718_55b9ece5-e9bc-532d-e054-00144ff8d46c 49349-718 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20110516 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 49349-733_40e542fd-854b-2282-e054-00144ff88e88 49349-733 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110721 ANDA ANDA062298 REMEDYREPACK INC. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 49349-754_4fae8f8b-72c0-30eb-e054-00144ff8d46c 49349-754 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20120718 NDA NDA021153 REMEDYREPACK INC. ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 49349-778_408177f3-9664-157f-e054-00144ff88e88 49349-778 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110916 ANDA ANDA079162 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 49349-779_3aed8ed9-ce1e-5368-e054-00144ff88e88 49349-779 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20110928 ANDA ANDA078154 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 49349-785_407f8aa0-2073-3867-e054-00144ff88e88 49349-785 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET ORAL 20110927 ANDA ANDA078069 REMEDYREPACK INC. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 49349-787_615a1916-b00f-4287-e053-2a91aa0a739e 49349-787 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20111010 ANDA ANDA077156 REMEDYREPACK INC. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 49349-789_574970ca-cfd0-76d8-e053-2991aa0ac146 49349-789 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20111024 ANDA ANDA078154 REMEDYREPACK INC. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 49349-792_517c77c7-67dd-6c16-e054-00144ff8d46c 49349-792 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 20111024 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. SENNOSIDES A AND B 8.6 mg/1 N 20181231 49349-802_405acbff-e488-2203-e054-00144ff88e88 49349-802 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20111031 ANDA ANDA079162 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 49349-811_401a0d22-10e7-02ac-e054-00144ff88e88 49349-811 HUMAN PRESCRIPTION DRUG LEXIVA fosamprenavir calcium TABLET, FILM COATED ORAL 20111111 NDA NDA021548 REMEDYREPACK INC. FOSAMPRENAVIR CALCIUM 700 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],P-Glycoprotein Inducers [MoA] E 20171231 49349-814_55cd4cee-7be8-2e7d-e054-00144ff8d46c 49349-814 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111114 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 49349-821_40183d1e-522b-3c85-e054-00144ff88e88 49349-821 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20111114 ANDA ANDA077987 REMEDYREPACK INC. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 49349-826_40183d1e-51bc-3c85-e054-00144ff88e88 49349-826 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin TABLET, FILM COATED ORAL 20111121 ANDA ANDA061621 REMEDYREPACK INC. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 49349-827_55cd4cee-7bcc-2e7d-e054-00144ff8d46c 49349-827 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20111114 ANDA ANDA072575 REMEDYREPACK INC. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 49349-852_3fbaf0f4-7edb-224f-e054-00144ff8d46c 49349-852 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111205 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 49349-865_3f8dc63a-f44b-6f2b-e054-00144ff8d46c 49349-865 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20120118 ANDA ANDA070791 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 49349-868_50d853fa-cd98-488a-e054-00144ff88e88 49349-868 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20120112 OTC MONOGRAPH FINAL part343 REMEDYREPACK INC. ASPIRIN 81 mg/1 N 20181231 49349-876_567fc67a-3d0a-4916-e054-00144ff88e88 49349-876 HUMAN OTC DRUG Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20141117 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. OXYMETAZOLINE HYDROCHLORIDE 5 g/100mL N 20181231 49349-899_36ea237d-d5f4-7206-e054-00144ff8d46c 49349-899 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20120119 ANDA ANDA077397 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 49349-901_5644dacb-5b98-419c-e054-00144ff88e88 49349-901 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20120209 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 49349-904_3f2e2e51-0394-1124-e054-00144ff8d46c 49349-904 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET ORAL 20120131 ANDA ANDA078069 REMEDYREPACK INC. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 49349-931_a3102f3d-3c7a-4b6e-ab6a-1239125d67f2 49349-931 HUMAN PRESCRIPTION DRUG Olanzapine OLANZAPINE TABLET, FILM COATED ORAL 20121213 ANDA ANDA076000 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 49349-933_5f8d08bd-13f3-5416-e053-2a91aa0a3a35 49349-933 HUMAN PRESCRIPTION DRUG Benztropine Mesylate BENZTROPINE MESYLATE TABLET ORAL 20121113 ANDA ANDA040742 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 49349-946_acee238b-9131-4bd7-bb17-f8e4c86babe0 49349-946 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRAMUSCULAR 20130411 NDA NDA014901 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 40 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 49349-947_da4e461e-becb-4654-9b8c-be512c4e36ee 49349-947 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRAMUSCULAR 20130411 NDA NDA014901 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 40 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 49349-957_5646e6cb-bffa-707b-e054-00144ff8d46c 49349-957 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 20120405 NDA NDA011153 REMEDYREPACK INC. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49349-958_513ec713-f94a-3cf0-e054-00144ff8d46c 49349-958 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20120413 UNAPPROVED DRUG OTHER REMEDYREPACK INC. PHENOBARBITAL 16.2 mg/1 CIV N 20181231 49349-959_402acc5f-7c20-534d-e054-00144ff8d46c 49349-959 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20161031 UNAPPROVED DRUG OTHER REMEDYREPACK INC. PHENOBARBITAL 64.8 mg/1 CIV E 20171231 49349-962_3e24a805-ee18-4af9-e054-00144ff8d46c 49349-962 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120413 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 49349-969_3e104d56-16a2-32d2-e054-00144ff88e88 49349-969 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20120418 ANDA ANDA040189 REMEDYREPACK INC. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49349-991_7c7c429c-14f9-4c4d-b1a6-2a2782aaf8ab 49349-991 HUMAN PRESCRIPTION DRUG FLuvoxamine Maleate FLUVOXAMINE MALEATE TABLET ORAL 20121015 NDA NDA021519 REMEDYREPACK INC. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 49349-993_3dfc4a1d-6f3d-33ab-e054-00144ff8d46c 49349-993 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20120818 ANDA ANDA079162 REMEDYREPACK INC. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 49349-998_563dab0d-730c-4bba-e054-00144ff88e88 49349-998 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20170808 ANDA ANDA079132 REMEDYREPACK INC. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49351-015_ecd79636-6f9a-4652-8ea5-d25f4dfa8900 49351-015 HUMAN OTC DRUG Tork Premium Triclosan LIQUID TOPICAL 20100303 OTC MONOGRAPH NOT FINAL part333 SCA Tissue North America TRICLOSAN .5 g/100mL E 20171231 49351-016_9f2186c0-1be3-4d63-bc13-281ebd9b263f 49351-016 HUMAN OTC DRUG Tork Premium Hand Sanitizer Foam Alcohol-Free Benzalkonium Chloride LIQUID TOPICAL 20100303 OTC MONOGRAPH NOT FINAL part333 SCA Tissue North America BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 49351-018_31c9f4b2-be43-406a-960f-35ee4443b9fe 49351-018 HUMAN OTC DRUG Tork Premium Hand Sanitizer Foam Alcohol LIQUID TOPICAL 20100423 OTC MONOGRAPH NOT FINAL part333 SCA Tissue North America ALCOHOL 67 mL/100mL E 20171231 49351-101_ac7515ec-a0de-4f40-98a8-5682c6a234c5 49351-101 HUMAN OTC DRUG Tork Hand Sanitizer Alcohol Gel Ethyl alcohol GEL TOPICAL 20140430 OTC MONOGRAPH NOT FINAL part333E SCA Tissue North America ALCOHOL 76 mL/100mL N 20181231 49351-103_a837515b-1ca5-47fc-925e-a5f2d8a486c9 49351-103 HUMAN OTC DRUG Tork Hand Sanitizer Alcohol Free Foam Benzalkonium Chloride LIQUID TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part333E SCA Tissue North America BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 49351-104_2537616b-861a-4c16-841a-449e667eace3 49351-104 HUMAN OTC DRUG Tork Foam Antibacterial benzalkonium chloride SOAP TOPICAL 20170315 OTC MONOGRAPH NOT FINAL part333E SCA Tissue North America LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 49351-200_ebbb8aa6-bccc-42f4-b7ea-2c1832ef934d 49351-200 HUMAN OTC DRUG Tork Hand Sanitizer Alcohol Foam Ethyl alcohol liquid LIQUID TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333E SCA Tissue North America ALCOHOL .72 mL/mL N 20181231 49351-201_066a8c5c-6ddd-489f-9c9b-5b2f96efadbd 49351-201 HUMAN OTC DRUG Tork Liquid Antibacterial Chloroxylenol LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part333A SCA Tissue North America CHLOROXYLENOL 2.75 g/100mL N 20181231 49351-202_1e5505c7-dd08-4c69-bf58-f134f26b80ef 49351-202 HUMAN OTC DRUG Tork Foam Antibacterial Chloroxylenol SOAP TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part333A SCA Tissue North America CHLOROXYLENOL 2.75 g/100mL N 20181231 49358-541_79924b9a-f6df-42f3-81ef-12d2ece358b0 49358-541 HUMAN OTC DRUG MDSolarSCIENCES Natural Mineral Sunscreen TITANIUM DIOXIDE and ZINC OXIDE LIPSTICK TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE .96; .792 g/12g; g/12g E 20171231 49358-542_c47ce0df-897a-40c0-9ce7-2731f2eb41b7 49358-542 HUMAN OTC DRUG MDSolarSciences Natural Mineral Sunscreen Tinted TITANIUM DIOXIDE and ZINC OXIDE GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE 2.7; 1.33 g/35g; g/35g E 20171231 49358-543_513e7f65-9bdf-405b-95ea-1761da4fe96a 49358-543 HUMAN OTC DRUG MDSOLARSCIENCES Natural Mineral Sunscreen Kid Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE 6.16; 3.04 g/80g; g/80g E 20171231 49358-544_e8b49e5d-db0c-44d0-a435-4bde9abcf38a 49358-544 HUMAN OTC DRUG MDSolarSciences SPF 40 Quick Dry Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MD Solar Sciences AVOBENZONE; OCTISALATE; OCTOCRYLENE 4.44; 7.4; 4.07 mL/148mL; mL/148mL; mL/148mL E 20171231 49358-545_f7b7e9ac-e198-4ed5-a5d4-ac83e5f244b0 49358-545 HUMAN OTC DRUG MDSolarSciences Natural Mineral Sunscreen Titanium Dioxide and Zinc Oxide LIPSTICK TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE .96; .792 g/12g; g/12g E 20171231 49358-546_bed494be-e4a1-4c46-8341-eee1a25f4cf8 49358-546 HUMAN OTC DRUG MDSOLARSCIENCES SPF 50 Mineral TITANIUM DIOXIDE and Zinc Oxide CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE 15; 170 mg/g; mg/g E 20171231 49358-547_8cdf78f7-851c-4362-be3d-7372fbb7a1df 49358-547 HUMAN OTC DRUG MDSOLARSCIENCES SPF 30 Mineral Tinted TITANIUM DIOXIDE and Zinc Oxide CREAM TOPICAL 20160101 OTC MONOGRAPH FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE 15; 170 mg/g; mg/g E 20171231 49358-548_c0669e4f-4fd4-42ab-8c09-151ef9775e96 49358-548 HUMAN OTC DRUG MDSOLARSCIENCES SPF 50 Mineral TITANIUM DIOXIDE and Zinc Oxide LOTION TOPICAL 20130201 OTC MONOGRAPH FINAL part352 MD Solar Sciences TITANIUM DIOXIDE; ZINC OXIDE 30; 150 mg/g; mg/g E 20171231 49358-549_312099f4-da7b-45b0-a478-bbb84915d19c 49358-549 HUMAN OTC DRUG MDSOLARSCIENCES Daily Anti Aging Moisturizer SPF 30 Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20130201 OTC MONOGRAPH FINAL part352 MD Solar Sciences AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 27.5 mg/mL; mg/mL; mg/mL E 20171231 49358-550_ba441b37-1228-4ddf-9bd3-99151ed96a9c 49358-550 HUMAN OTC DRUG Mineral Beauty Balm Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen Light/Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part352 MDSolarSciences TITANIUM DIOXIDE; ZINC OXIDE 2.7; 1.3 g/35g; g/35g E 20171231 49358-551_ba441b37-1228-4ddf-9bd3-99151ed96a9c 49358-551 HUMAN OTC DRUG Mineral Beauty Balm Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen Medium/Dark Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part352 MDSolarSciences TITANIUM DIOXIDE; ZINC OXIDE 2.7; 1.3 g/35g; g/35g E 20171231 49358-552_63b5403d-10c3-4f08-9e80-0550f6bccd8d 49358-552 HUMAN OTC DRUG Mineral Creme Broad Spectrum SPF 30 Sunscreen UVA-UVB Suncreen Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part352 MDSolarSciences TITANIUM DIOXIDE; ZINC OXIDE 2.7; 1.3 g/35g; g/35g E 20171231 49358-553_08a61634-a495-4283-ac6d-1f607ee6bd91 49358-553 HUMAN OTC DRUG Mineral Sunscreen Broad Spectrum SPF 40 Sunscreen UVA-UVB Sunscreen Titanium Dioxide and Zinc Oxide STICK TOPICAL 20160201 OTC MONOGRAPH FINAL part352 MDSolarSciences TITANIUM DIOXIDE; ZINC OXIDE .96; .792 g/12g; g/12g E 20171231 49358-554_dc5468a8-2150-4b94-8509-b122098b80cb 49358-554 HUMAN OTC DRUG Mineral Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20160101 OTC MONOGRAPH FINAL part352 MDSolarSciences TITANIUM DIOXIDE; ZINC OXIDE 2.7; 1.3 g/35g; g/35g E 20171231 49358-555_ce1ca804-a1ba-4fcc-94ab-192583acd612 49358-555 HUMAN OTC DRUG Daily Anti-Aging Moisturizer Broad Spectrum SPF30 Sunscreen UVA-UVB Sunscreen with SolSci-X Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20150301 OTC MONOGRAPH FINAL part352 MDSolarSciences AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 27.5 mg/mL; mg/mL; mg/mL E 20171231 49358-556_7434ceaa-74a5-49ce-9f97-deb2fded07db 49358-556 HUMAN OTC DRUG Quick Dry Body Broad Spectrum SPF40 Sunscreen UVA-UVB Sunscreen with SolSci-X Avobenzone, Octisalate, and Octocrylene SPRAY TOPICAL 20150301 OTC MONOGRAPH FINAL part352 MDSolarSciences AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 2.75 g/100g; g/100g; g/100g E 20171231 49358-558_38f8afed-d59b-447d-8234-a455e79fa18d 49358-558 HUMAN OTC DRUG Mineral Moisture Defense Broad Spectrum SPF 50 Sunscreen UVA-UVB Suncreen Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20160101 OTC MONOGRAPH FINAL part352 MDSolarSciences TITANIUM DIOXIDE; ZINC OXIDE 2.7; 1.3 g/35g; g/35g E 20171231 49358-559_78e47f70-5225-4f02-ae50-a619b69e1bfb 49358-559 HUMAN OTC DRUG KidCreme Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB Suncreen Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20170616 OTC MONOGRAPH FINAL part352 MDSolarSciences TITANIUM DIOXIDE; ZINC OXIDE 2.7; 1.3 g/35g; g/35g N 20181231 49358-560_b703b70a-688b-438d-9cde-f71a9508ecaa 49358-560 HUMAN OTC DRUG KidStick Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB Sunscreen Titanium Dioxide and Zinc Oxide STICK TOPICAL 20170616 OTC MONOGRAPH FINAL part352 MDSolarSciences TITANIUM DIOXIDE; ZINC OXIDE .96; .792 g/12g; g/12g N 20181231 49363-9901_f12b1c11-8974-4976-a9df-c5d764661401 49363-9901 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Gano Welding Supplies, Inc OXYGEN 99.5 L/100L E 20171231 49364-110_08d050e8-f5dc-4dca-bbef-833156e28729 49364-110 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101109 ANDA ANDA065248 Strategic Pharmaceutical Solutions, Inc. DBA VetSource CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 49364-111_08d050e8-f5dc-4dca-bbef-833156e28729 49364-111 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101109 ANDA ANDA065248 Strategic Pharmaceutical Solutions, Inc. DBA VetSource CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 49371-015_cbdbc8ef-91cc-44d8-a11c-1432d923837c 49371-015 HUMAN OTC DRUG Pier 1 Imports Blueberry Parfait Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-016_1c46a615-7e92-4c1d-af2a-e108ddaced8d 49371-016 HUMAN OTC DRUG Pier 1 Imports Cherry Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-017_ecef821f-08e2-46ba-8b2b-c3babccf0c26 49371-017 HUMAN OTC DRUG Pier 1 Imports Lavender Vanilla Anti-Bacterial Hand Sanitizer Pier 1 Imports Hand Sanitizer LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-018_da3a1bbf-7260-4c23-8902-3cd33536427f 49371-018 HUMAN OTC DRUG Pier 1 Imports Lily blossom Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-019_715ddd48-f14b-4282-992f-b31ed82e418e 49371-019 HUMAN OTC DRUG Pier 1 Imports Melon and Mint Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-020_3d3c09cf-7bf4-4a10-a2c0-b8fc98c834c7 49371-020 HUMAN OTC DRUG Pier 1 Imports Passion Fruit Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-021_6b751edb-e42b-4da2-88fa-c904b130ec72 49371-021 HUMAN OTC DRUG Wild Strawberry Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-022_36ed9405-5b62-45ea-ad2f-82f2d3e0fb7e 49371-022 HUMAN OTC DRUG Peach Mango Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-023_6709c311-85cd-4c38-935e-eb76ad1e6d29 49371-023 HUMAN OTC DRUG Coconut Lime Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-024_9fbf3e68-9a84-4b24-9926-724c9ba4539f 49371-024 HUMAN OTC DRUG Mandarin Orange Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-025_2b032c9b-765a-458f-a383-15a36660d175 49371-025 HUMAN OTC DRUG Pier 1 Imports Crisp Bamboo Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-026_3f1b7dd3-e565-41bd-895e-0f18849f6ac2 49371-026 HUMAN OTC DRUG Pier 1 Imports Ginger Peach Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-027_4361f570-3903-430f-a086-bbf0310e488c 49371-027 HUMAN OTC DRUG Pier 1 Imports Lavender Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-028_a66ee6bb-c3ef-4383-8724-e0fc0329ac21 49371-028 HUMAN OTC DRUG Pier 1 Imports Iced Cookie Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-030_24b3b68e-9e1d-4bee-9c8a-c7a01b4cb642 49371-030 HUMAN OTC DRUG Pier 1 Imports Sugared Plum Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-031_85260ee1-f2be-4671-b1de-f5333b42a686 49371-031 HUMAN OTC DRUG Pier 1 Imports Vanilla Mint Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-032_6985404e-5215-4208-a053-9590e12236b3 49371-032 HUMAN OTC DRUG Healing Water Amber Flower Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100320 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-033_5cdd43ba-b909-4606-b2a0-f87149e84e60 49371-033 HUMAN OTC DRUG Healing Waters Vanilla Orchid Anti-Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100320 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-034_2e9aa2df-d3b6-4527-ae44-ee0fe1fddce1 49371-034 HUMAN OTC DRUG Dots Apple Cinnamon Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-035_619e7ed6-491d-4863-a12b-b66f61b2eeb4 49371-035 HUMAN OTC DRUG Dots Asian Spice Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-036_e8be399f-69a5-41eb-987e-531ac530b69d 49371-036 HUMAN OTC DRUG Lavender Vanilla Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-037_2db88a46-707d-4e5d-bd20-c321e98cd9d6 49371-037 HUMAN OTC DRUG Wild Strawberry Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-038_abce3d3b-c12e-4313-9d27-79bc961ff771 49371-038 HUMAN OTC DRUG Love and Beauty Melon and Mint Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-039_54ecb3f0-5b0a-4d51-9cf1-d45aa92faddf 49371-039 HUMAN OTC DRUG Love and Beauty Peach Mango Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-040_b38e4d1d-4194-47ea-be1f-6ddd4bbbf25c 49371-040 HUMAN OTC DRUG Rue 21 Asian Spice Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-041_bee9a57a-7599-43c4-9bc5-34c67ef5ebf3 49371-041 HUMAN OTC DRUG Rue21 Coco Breeze Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-042_7a446ab9-2daf-4180-bacf-3042d6ec70ba 49371-042 HUMAN OTC DRUG Rue21 Island Fruits Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-043_c644b1a4-67b6-43a6-9229-bb08162f0cdf 49371-043 HUMAN OTC DRUG Rue21 Ocean Anti-Bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. ALCOHOL 62 g/100g E 20171231 49371-044_8c686337-2236-4bae-bc4e-d09de3133ee6 49371-044 HUMAN OTC DRUG Aromafields Jasmine Scented Anti-Bacterial Hand Triclosan LOTION TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. TRICLOSAN .15 g/100g E 20171231 49371-045_35006f88-a5bc-4633-ab70-9cafa6f41301 49371-045 HUMAN OTC DRUG Aromafields Lavender Scented Anti-Bacterial Hand Triclosan LOTION TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. TRICLOSAN .15 g/100g E 20171231 49371-046_0bbf7e17-819b-44e5-9d17-96a9ca3401a7 49371-046 HUMAN OTC DRUG Aromafields Plumeria Scented Anti-Bacterial Hand Triclosan LOTION TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. TRICLOSAN .15 g/100g E 20171231 49371-047_83d16199-e5b8-4aa3-abdc-1da530b74238 49371-047 HUMAN OTC DRUG Aromafields Tiger Lily Scented Anti-Bacterial Hand Triclosan LOTION TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part333 ALILY (ZHANGZHOU) BATH PRODUCTS LTD. TRICLOSAN .15 g/100g E 20171231 49390-100_095640b9-b5fc-4988-bd91-c7b11e9cb0d6 49390-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091201 UNAPPROVED MEDICAL GAS Linweld, Inc. OXYGEN 995 mL/L E 20171231 49390-300_76f28081-a5b6-4da7-9784-ee6462d709c0 49390-300 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20091201 UNAPPROVED MEDICAL GAS Linweld, Inc NITROGEN 99 mL/L E 20171231 49401-088_bdb3042f-a604-455a-bbd3-d263a9130c75 49401-088 HUMAN PRESCRIPTION DRUG BENLYSTA belimumab SOLUTION SUBCUTANEOUS 20170720 BLA BLA761043 Human Genome Sciences, Inc. BELIMUMAB 200 mg/mL Decreased B Lymphocyte Activation [PE],B Lymphocyte Stimulator-specific Inhibitor [EPC],B Lymphocyte Stimulator-directed Antibody Interactions [MoA] N 20181231 49401-101_bdb3042f-a604-455a-bbd3-d263a9130c75 49401-101 HUMAN PRESCRIPTION DRUG BENLYSTA belimumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110310 BLA BLA125370 Human Genome Sciences, Inc. BELIMUMAB 120 mg/1.5mL Decreased B Lymphocyte Activation [PE],B Lymphocyte Stimulator-specific Inhibitor [EPC],B Lymphocyte Stimulator-directed Antibody Interactions [MoA] N 20181231 49401-102_bdb3042f-a604-455a-bbd3-d263a9130c75 49401-102 HUMAN PRESCRIPTION DRUG BENLYSTA belimumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110310 BLA BLA125370 Human Genome Sciences, Inc. BELIMUMAB 400 mg/5mL Decreased B Lymphocyte Activation [PE],B Lymphocyte Stimulator-specific Inhibitor [EPC],B Lymphocyte Stimulator-directed Antibody Interactions [MoA] N 20181231 49401-103_d0fdec4e-5d92-4466-9c58-7c1fc95a9b4e 49401-103 HUMAN PRESCRIPTION DRUG Raxibacumab raxibacumab INJECTION INTRAVENOUS 20121214 BLA BLA125349 Human Genome Sciences, Inc. RAXIBACUMAB 50 mg/mL Anthrax Protective Antigen-directed Antibody [EPC],Anthrax Protective Antigen-directed Antibody Interactions [MoA] N 20191231 49401-104_d0fdec4e-5d92-4466-9c58-7c1fc95a9b4e 49401-104 HUMAN PRESCRIPTION DRUG Raxibacumab raxibacumab INJECTION INTRAVENOUS 20121214 BLA BLA125349 Human Genome Sciences, Inc. RAXIBACUMAB 50 mg/mL Anthrax Protective Antigen-directed Antibody [EPC],Anthrax Protective Antigen-directed Antibody Interactions [MoA] N 20191231 49404-100_eb6c9dea-6078-4cf5-b3bb-ad7d7a44c67a 49404-100 HUMAN OTC DRUG Dr. Jart Water Fuse Beauty Balm Titanium Dioxide, Octinoxate, Octisalate EMULSION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Have and Be Co.,Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 3.611; 3; 2.25 mg/50mL; mg/50mL; mg/50mL N 20181231 49404-101_8d9db43d-ec41-4b73-ac82-5776fa73e5b7 49404-101 HUMAN OTC DRUG Dr. Jart Premium Beauty Balm Titanium Dioxide, Zinc Oxide EMULSION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Have and Be Co.,Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.606; 2.522 mg/40mL; mg/40mL N 20181231 49404-106_edaab6ff-7774-400a-a90f-61e35ee02026 49404-106 HUMAN OTC DRUG Dr.Jart Renewalist BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120730 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 2.704; 1.891 mL/30mL; mL/30mL N 20181231 49404-107_f4680ef0-a28c-4a87-aecb-6f9cd1504668 49404-107 HUMAN OTC DRUG Dr.Jart Black Label Detox BB Beaty Balm Titanium Dioxide, Zinc Oxide EMULSION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.8132; 1.536 mg/40mL; mg/40mL N 20181231 49404-118_035c5b88-3b89-47c2-8843-2efef798b715 49404-118 HUMAN OTC DRUG Dr.Jart BB Mate Contouring 01 Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20141027 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .695; .24; .0588 mg/6mL; mg/6mL; mg/6mL N 20181231 49404-119_49b912b3-e118-4ec0-b927-3643a33cf3f8 49404-119 HUMAN OTC DRUG Dr.Jart BB Mate Contouring 02 Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20141027 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .567; .24; .0588 mg/6mL; mg/6mL; mg/6mL N 20181231 49404-120_00aeb51b-bc8a-491f-ade1-e95fff35548e 49404-120 HUMAN OTC DRUG Dr.Jart BB Mate Contouring 03 Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20141027 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .566; .24; .059 mg/6mL; mg/6mL; mg/6mL N 20181231 49404-121_3f0670c8-e266-0537-e054-00144ff8d46c 49404-121 HUMAN OTC DRUG Dr.Jart Premium Beauty Balm 02 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.606; 2.522 mg/40mL; mg/40mL N 20181231 49404-122_3f975996-6749-1003-e054-00144ff88e88 49404-122 HUMAN OTC DRUG Dr.Jart Ceramidin Day Tint Octinoxate, Octisalate CREAM TOPICAL 20150114 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. OCTINOXATE; OCTISALATE 3; 1 mg/50mL; mg/50mL N 20181231 49404-123_3f05d53a-fbf1-1eee-e054-00144ff88e88 49404-123 HUMAN OTC DRUG Dr.Jart Bounce Beauty Balm Moist 01 Light Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150127 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 1.2036; .3456 g/12g; g/12g N 20181231 49404-124_3f077d4c-575c-530a-e054-00144ff88e88 49404-124 HUMAN OTC DRUG Dr.Jart Bounce Beauty Balm Moist 02 Medium Deep Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150126 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 1.2036; .3456 g/12g; g/12g N 20181231 49404-126_3f077d4c-5767-530a-e054-00144ff88e88 49404-126 HUMAN OTC DRUG Dr.Jart Dis-A-Pore Beauty Balm 02 MEDIUM-DEEP TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20151230 OTC MONOGRAPH NOT FINAL part352 Have & Be Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.73; 2; .49 mg/50mL; mg/50mL; mg/50mL N 20181231 49404-127_3f077d4c-5791-530a-e054-00144ff88e88 49404-127 HUMAN OTC DRUG Dr. Jart Illuminating BB Brush TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 Have & Be Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.68; 2; 1.96 mg/40mL; mg/40mL; mg/40mL N 20181231 49404-128_3f077d4c-577b-530a-e054-00144ff88e88 49404-128 HUMAN OTC DRUG Dr.Jart Every Sun Day Illuminating Sunscreen SPF 36 OCTINOXATE, OCTISALATE, ENSULIZOLE, TITANIUM DIOXIDE, OCTOCRYLENE CREAM TOPICAL 20160125 OTC MONOGRAPH NOT FINAL part352 Have & Be Co., Ltd. OCTINOXATE; OCTISALATE; ENSULIZOLE; TITANIUM DIOXIDE; OCTOCRYLENE 3.5; 2.25; 2; 1.15; .5 mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 49404-129_3f08263a-352c-67ca-e054-00144ff88e88 49404-129 HUMAN OTC DRUG Dr.Jart Every Sun Day Sun Fluid SPF 30 HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20160125 OTC MONOGRAPH NOT FINAL part352 Have & Be Co., Ltd. HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 10; 5; 5; 3 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 49404-130_3f42326a-6b16-31eb-e054-00144ff88e88 49404-130 HUMAN OTC DRUG Dr.Jart Every Sun Day Sunscreen SPF 50 ZINC OXIDE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20160125 OTC MONOGRAPH NOT FINAL part352 Have & Be Co., Ltd. ZINC OXIDE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 6.33; 3.4; 2.25; 1.25 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 49404-131_c4821ee9-cc80-4e5e-9414-0c8b47d11255 49404-131 HUMAN OTC DRUG Dr.Jart Dermask Micro Jet Clearing Solution NIACINAMIDE, SALICYLIC ACID CREAM TOPICAL 20161102 UNAPPROVED DRUG OTHER Have & Be Co., Ltd. NIACINAMIDE; SALICYLIC ACID .54; .00027 g/27g; g/27g N 20181231 49404-132_3f08263a-3545-67ca-e054-00144ff88e88 49404-132 HUMAN OTC DRUG Dr.Jart Cicapair Tiger Grass Color Correcting Treatment TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20160526 OTC MONOGRAPH NOT FINAL part352 Have & Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3.08; 1.44 mg/50mL; mg/50mL N 20181231 49404-133_3fc3e89d-3bf2-3a8d-e054-00144ff8d46c 49404-133 HUMAN OTC DRUG Dr.Jart Air Mesh TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20161021 OTC MONOGRAPH NOT FINAL part352 Have & Be Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.1346; .48; .1176 g/12g; g/12g; g/12g N 20181231 49404-134_30bb91c5-56bc-40c7-8d4f-8b27af87ead0 49404-134 HUMAN OTC DRUG DTRT Boys Be Bold BB SPF 25 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20161021 OTC MONOGRAPH NOT FINAL part352 Have & Be Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.914; .9; .576 mg/30mL; mg/30mL; mg/30mL N 20181231 49404-135_9d866c4d-f369-4804-88e7-bcd7bee757bd 49404-135 HUMAN OTC DRUG DTRT Get Ready BB SPF 50 Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170626 OTC MONOGRAPH NOT FINAL part352 Have & Be Co., Ltd. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 2.25; 1.5; 1.47; .87 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 49404-136_d76108eb-0286-4b20-bce2-0e560f145476 49404-136 HUMAN OTC DRUG Dr.Jart Premuim Beauty Balm 03 Deep Octinoxate, Octisalate CREAM TOPICAL 20180108 OTC MONOGRAPH NOT FINAL part352 Have & Be Co., Ltd. OCTINOXATE; OCTISALATE 2.71; 1.8 mg/40mL; mg/40mL N 20191231 49404-202_601ee72a-97b2-4c90-a5ef-9eba173bf775 49404-202 HUMAN OTC DRUG Dr. Jart DIS-A-PORE Beauty Balm Titanium Dioxide, Octinoxate, Zinc Oxide EMULSION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 4.7275; .49; 2 mg/50mL; mg/50mL; mg/50mL N 20181231 49404-203_5a626c5d-6f27-4a94-8ecb-1152bb78c228 49404-203 HUMAN OTC DRUG Dr. Jart RADIANCE Beauty Balm Titanium Dioxide, Octinoxate, Zinc Oxide EMULSION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Have and Be Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 3.78; .392; 1.6 mg/40mL; mg/40mL; mg/40mL N 20181231 49406-003_4d10d0cc-1d73-7214-e054-00144ff88e88 49406-003 HUMAN OTC DRUG Formula 3 TOLNAFTATE SOLUTION TOPICAL 20121030 OTC MONOGRAPH FINAL part333C The Tetra Corporation TOLNAFTATE 10 mg/mL N 20181231 49406-004_617d5645-ab31-dcdf-e053-2991aa0a6019 49406-004 HUMAN OTC DRUG FungiFoam TOLNAFTATE AEROSOL, FOAM TOPICAL 20121031 OTC MONOGRAPH FINAL part333C The Tetra Corporation TOLNAFTATE 10 mg/mL N 20181231 49410-200_62180c5e-1369-1c60-e053-2a91aa0a3668 49410-200 HUMAN OTC DRUG teeth desensitizing and remineralizing gel Potassium nitrate,Sodium Fluoride,Sodium Monofluorophosphate PASTE DENTAL 20160307 OTC MONOGRAPH NOT FINAL part356 Fuzhou Difeng Bio-tech Co., Ltd. POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20191231 49411-050_bba3bfb1-b56e-4370-8b68-25f18db3fc02 49411-050 HUMAN PRESCRIPTION DRUG AMICAR Aminocaproic Acid TABLET ORAL 20150601 NDA NDA015197 Clover Pharmaceuticals Corp. AMINOCAPROIC ACID 500 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 49411-051_bba3bfb1-b56e-4370-8b68-25f18db3fc02 49411-051 HUMAN PRESCRIPTION DRUG AMICAR Aminocaproic Acid TABLET ORAL 20150601 NDA NDA015197 Clover Pharmaceuticals Corp. AMINOCAPROIC ACID 1000 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 49411-052_bba3bfb1-b56e-4370-8b68-25f18db3fc02 49411-052 HUMAN PRESCRIPTION DRUG AMICAR Aminocaproic Acid SOLUTION ORAL 20150601 NDA NDA015230 Clover Pharmaceuticals Corp. AMINOCAPROIC ACID .25 g/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 49415-0001_e5c5d38a-1e49-4369-b2d5-a5f0bea5ed1e 49415-0001 HUMAN OTC DRUG HGH Complex Arnica Montana, Carduus Marianus, Hepar Suis, Panax Ginseng, Phosphoricum Acidum, Hypophysis Suis SPRAY ORAL 20131230 UNAPPROVED HOMEOPATHIC Maximum Results Solution, Inc. ARNICA MONTANA; SILYBUM MARIANUM SEED; PORK LIVER; ASIAN GINSENG; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND 3; 1; 6; 1; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49415-0002_4446b99e-1efe-43b2-a710-c475d62800e4 49415-0002 HUMAN OTC DRUG Weight Loss Solution Amino Acids, Apis Mellifica, Arnica Montana, Fucus Vesiculosus, Gambogia, Hepar Suis, Phosphoricum Acidum, Pituitaria Glandula Suis, Thuja Occidentalis, Thyroidinum Suis, SPRAY ORAL 20131025 UNAPPROVED HOMEOPATHIC Maximum Results Solution, Inc. AMINO ACIDS; APIS MELLIFERA; ARNICA MONTANA; FUCUS VESICULOSUS; GAMBOGE; PORK LIVER; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAF; SUS SCROFA THYROID 6; 4; 3; 3; 3; 6; 3; 24; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 49415-0004_3657946e-bbf6-4e78-aef0-5cd6393accbe 49415-0004 HUMAN OTC DRUG HGH Complex Arnica Montana, Carduus Marianus, Hepar Suis, Hypophysis Suis, Panax Ginseng, Phosphoricum Acidum SPRAY ORAL 20170801 UNAPPROVED HOMEOPATHIC Maximum Results Solution, Inc. ARNICA MONTANA; SILYBUM MARIANUM SEED; PORK LIVER; SUS SCROFA PITUITARY GLAND; ASIAN GINSENG; PHOSPHORIC ACID 3; 1; 6; 12; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49415-0005_6554d405-8bc0-4a13-839e-64a4d5a253c2 49415-0005 HUMAN OTC DRUG H7 Complex Arnica Montana, Carduus Marianus, Hepar Suis, Hypophysis Suis, Panax Ginseng, Phosphoricum Acidum SPRAY ORAL 20171129 UNAPPROVED HOMEOPATHIC Maximum Results Solution, Inc. ARNICA MONTANA; SILYBUM MARIANUM SEED; PORK LIVER; SUS SCROFA PITUITARY GLAND; ASIAN GINSENG; PHOSPHORIC ACID 3; 1; 6; 12; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49435-001_290f5411-fda4-6521-e054-00144ff88e88 49435-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160111 OTC MONOGRAPH NOT FINAL part333E NPW-USA, Inc. ALCOHOL 62 mL/100mL N 20181231 49436-290_d21e1381-d9f9-495e-9037-23e1443483d7 49436-290 HUMAN OTC DRUG PurTect PETROLATUM, CHLOROXYLENOL OINTMENT TOPICAL 20120501 OTC MONOGRAPH FINAL part346 PurKlenz Formulations Inc. PETROLATUM; CHLOROXYLENOL 63; .8 mL/100mL; mL/100mL N 20181231 49436-291_e9acef71-ae6f-4cb3-b9f4-b1642b3ec7cf 49436-291 HUMAN OTC DRUG PurKlenz CHLOROXYLENOL LIQUID TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part333E PurKlenz Formulations Inc. CHLOROXYLENOL 2.949 g/100mL N 20191231 49436-292_6a7006c4-222a-4def-9072-15e96e0c718c 49436-292 HUMAN OTC DRUG PurSan CHLOROXYLENOL LOTION TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333E PurKlenz Formulations Inc. CHLOROXYLENOL .08 mg/100mL N 20181231 49449-100_c3be950b-28cf-47c2-9570-ebd46e43b1ba 49449-100 HUMAN OTC DRUG TCX Skincare Colloidal Oatmeal CREAM TOPICAL 20120517 OTC MONOGRAPH FINAL part347 Theraceutix, LLC OATMEAL 2 mL/100mL N 20181231 49467-104_9d340806-5ccc-4f8d-a227-9609c2d1fa2c 49467-104 HUMAN OTC DRUG NAUS-EASE MECLIZINE HYDROCHLORIDE FILM, SOLUBLE ORAL 20120416 OTC MONOGRAPH FINAL part336 Sunascen Therapeutics LLC MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 49467-124_267b73c1-511c-4403-bc3e-45006e02d517 49467-124 HUMAN OTC DRUG NAUS-EASE MECLIZINE HYDROCHLORIDE TABLET ORAL 20120416 ANDA ANDA040659 Sunascen Therapeutics LLC MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 49471-001_2fbcc40c-f102-4abe-bce5-a93de95874fe 49471-001 HUMAN PRESCRIPTION DRUG PRE-PEN benzylpenicilloyl polylysine INJECTION INTRADERMAL; SUBCUTANEOUS 19740725 NDA NDA050114 AllerQuest LLC BENZYLPENICILLOYL POLYLYSINE 60 umol/.25mL E 20171231 49479-498_d01fc8e5-ede8-49c1-b3cd-81a2c7f9132a 49479-498 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20130628 NDA NDA205985 Praxair Canada, Inc. NITROGEN 990 mL/L N 20181231 49479-720_80a0d50d-c559-46ae-a04c-67f9505006e3 49479-720 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130628 NDA NDA205986 Praxair Canada, Inc. OXYGEN 990 mL/L N 20181231 49483-003_5461e0e3-f8c3-4e22-8b60-52f82ccd45db 49483-003 HUMAN OTC DRUG STIMULANT LAXATIVE BISACODYL TABLET, DELAYED RELEASE ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 TIME CAP LABORATORIES, INC. BISACODYL 5 mg/1 N 20181231 49483-011_44323eb2-3218-42a3-92a3-35569c11d8f8 49483-011 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, COATED ORAL 20140402 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABS INC ASPIRIN 325 mg/1 N 20181231 49483-016_ad109144-ae93-4679-9b66-927a1a89cea2 49483-016 HUMAN OTC DRUG PSEUDO-TIME PSEUDOEPHEDRINE HCL TABLET, COATED ORAL 20120501 OTC MONOGRAPH FINAL part341 TIME CAP LABORATORIES, INC. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 49483-046_8da3d6dc-fb6e-48f5-bacb-5ab1c5ec9e30 49483-046 HUMAN OTC DRUG NEW CORRECT BISACODYL TABLET, DELAYED RELEASE ORAL 20080806 OTC MONOGRAPH NOT FINAL part334 Time-Cap Labs, Inc BISACODYL 5 mg/1 N 20181231 49483-052_b1c1f6da-f87a-4e89-b9ad-da6a79573184 49483-052 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, DELAYED RELEASE ORAL 20120508 OTC MONOGRAPH FINAL part343 TIME CAP LABORATORIES INC. ASPIRIN 325 mg/1 N 20181231 49483-054_15e2f689-ed8f-4cdd-b00e-cd0358b2cfda 49483-054 HUMAN OTC DRUG MINIPRIN ASPIRIN TABLET, COATED ORAL 20120507 OTC MONOGRAPH FINAL part343 TIME CAP LABORATORIES, INC ASPIRIN 81 mg/1 N 20181231 49483-061_dcd4537b-a1f5-4081-8aa8-7c168135fb05 49483-061 HUMAN OTC DRUG ALLER-G-TIME DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120501 OTC MONOGRAPH FINAL part341 TIME CAP LABORATORIES, INC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49483-080_790c6fca-0100-4f6a-83ef-729befb7feef 49483-080 HUMAN OTC DRUG SENNA TIME SENNOSIDES TABLET, COATED ORAL 20120514 OTC MONOGRAPH NOT FINAL part334 TIME CAP LABORATORIES, INC SENNOSIDES A AND B 8.6 mg/1 N 20181231 49483-081_52a597bd-4088-4688-8b95-f4c28ebe7ba4 49483-081 HUMAN OTC DRUG SENNA TIME S DOCUSATE SODIUM-SENNOSIDES TABLET, FILM COATED ORAL 20120514 OTC MONOGRAPH NOT FINAL part334 TIME CAP LABORATORIES, INC DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; min/1 N 20181231 49483-097_f3dcbb41-3272-4f01-b244-96245eab31bb 49483-097 HUMAN OTC DRUG SENNOSIDES AND DOCUSATE SODIUM SENNOSIDES AND DOCUSATE SODIUM TABLET, FILM COATED ORAL 20100101 OTC MONOGRAPH NOT FINAL part334 TIME CAP LABORATORIES, INC SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 49483-221_0985311e-10c0-43fe-bb8c-e720c325bb69 49483-221 HUMAN PRESCRIPTION DRUG NITRO-TIME NITROGLYCERIN CAPSULE ORAL 20140619 UNAPPROVED DRUG OTHER TIME CAP LABORATORIES, INC NITROGLYCERIN 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 49483-222_0985311e-10c0-43fe-bb8c-e720c325bb69 49483-222 HUMAN PRESCRIPTION DRUG NITRO-TIME NITROGLYCERIN CAPSULE ORAL 20140619 UNAPPROVED DRUG OTHER TIME CAP LABORATORIES, INC NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 49483-223_0985311e-10c0-43fe-bb8c-e720c325bb69 49483-223 HUMAN PRESCRIPTION DRUG NITRO-TIME NITROGLYCERIN CAPSULE ORAL 20140619 UNAPPROVED DRUG OTHER TIME CAP LABORATORIES, INC NITROGLYCERIN 9 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 49483-234_2709c2f7-6835-4f5b-b3ef-77aaec7f2025 49483-234 HUMAN OTC DRUG PSEUDO TIME PE PHENYLEPHRINE HCHLORIDE TABLET, FILM COATED ORAL 20120514 OTC MONOGRAPH NOT FINAL part341 TIME CAP LABORATORIES, INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 49483-242_ed77fca7-5e50-416e-8ef6-9d4fe08ccb61 49483-242 HUMAN OTC DRUG Allergy Time Chlorpheniramine Maleate TABLET ORAL 20110208 OTC MONOGRAPH FINAL part341 Time Cap Labs Inc CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 49483-252_697a6cd9-ba32-4069-a59a-6b6ae8c76a38 49483-252 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20110712 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABS INC ACETAMINOPHEN 500 mg/1 N 20181231 49483-272_89e46bbb-e592-4892-8be4-aa5956544edf 49483-272 HUMAN OTC DRUG MUCOSA GUAIFENESIN TABLET ORAL 20120416 OTC MONOGRAPH FINAL part341 TIME CAP LABORATORIES,INC GUAIFENESIN 400 mg/1 N 20181231 49483-280_6b0db81c-fba0-4305-a34d-f849af1f575a 49483-280 HUMAN OTC DRUG MUCOSA DM GUAIFENESIN DEXTROMETHORPHAN TABLET ORAL 20120417 OTC MONOGRAPH FINAL part341 TIME CAP LABORATORIES, INC. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 49483-328_e449eb3e-6363-4f5d-be12-d2982ca4739d 49483-328 HUMAN OTC DRUG Low Dose Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20100811 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/1 N 20181231 49483-329_42e5cb1a-5f14-4c2e-ad9e-6478c07f99de 49483-329 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20100301 OTC MONOGRAPH FINAL part341 Time-Cap Labs, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49483-330_c9db41ce-82b3-45c6-bcbc-0466d5169819 49483-330 HUMAN OTC DRUG Low Dose Miniprin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20100811 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/1 N 20181231 49483-331_6c52b0ef-7098-48c2-a9fd-c998c06b1272 49483-331 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength Aspirin TABLET, DELAYED RELEASE ORAL 20110104 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 325 mg/3251 N 20181231 49483-333_83fa6fe0-38f3-4538-9334-cfb15f77fe56 49483-333 HUMAN OTC DRUG Motion-Time Chewable Meclizine HCl TABLET, CHEWABLE ORAL 20100809 OTC MONOGRAPH FINAL part336 Time-Cap Labs, Inc MECLIZINE HYDROCHLORIDE 25 mg/251 N 20181231 49483-334_7cbe5b15-f6f6-49a3-ba9a-cf4ba9389113 49483-334 HUMAN OTC DRUG aspirin low dose chewable aspirin TABLET, CHEWABLE ORAL 20100716 OTC MONOGRAPH NOT FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/1 N 20181231 49483-340_ca914f43-ad7a-4538-a264-12d56aac5fb1 49483-340 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20111215 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABS INC ACETAMINOPHEN 325 mg/1 N 20181231 49483-341_af176493-5b64-4dcc-bd1a-e01517146737 49483-341 HUMAN OTC DRUG ACETAMINOPHEN EXTRA STRENGTH ACETAMINOPHEN TABLET, FILM COATED ORAL 20110718 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABS INC ACETAMINOPHEN 500 mg/1 N 20181231 49483-342_308c3978-c956-4b2e-9275-21791ed922dd 49483-342 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET, FILM COATED ORAL 20120501 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABORATORIES, INC ACETAMINOPHEN 500 mg/1 N 20181231 49483-343_36c720dd-a758-4033-b925-24b8b6b7b7e1 49483-343 HUMAN OTC DRUG Alert Caffeine TABLET, FILM COATED ORAL 20111130 OTC MONOGRAPH FINAL part340 Time Cap Labs, Inc CAFFEINE 200 mg/1 N 20181231 49483-347_23c705a0-380c-4de8-b00d-b704cc023c3c 49483-347 HUMAN OTC DRUG Comfort-Time Acetaminophen, Caffeine, and Pyrilamine Maleate TABLET, FILM COATED ORAL 20111130 OTC MONOGRAPH NOT FINAL part343 Time Cap Labs, Inc ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 49483-349_9b82ef2e-c898-4a71-be2d-ee22806bca24 49483-349 HUMAN OTC DRUG Aspirin Delayed Release Aspirin TABLET, DELAYED RELEASE ORAL 20101223 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/811 N 20181231 49483-352_1a1fa4eb-5672-4f61-8e95-2c5f00d08f69 49483-352 HUMAN OTC DRUG DIMENHYDRINATE DIMENHYDRINATE TABLET, FILM COATED ORAL 20110128 OTC MONOGRAPH FINAL part336 Time Cap Labs, Inc DIMENHYDRINATE 50 mg/1 N 20181231 49483-356_92884990-789c-40b6-a937-2b3da8c4a58f 49483-356 HUMAN OTC DRUG TIME-GESIC ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20121218 OTC MONOGRAPH FINAL part341 Time-Cap Labs, Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 325; 12.5 mg/1; mg/1 N 20181231 49483-370_ece45d42-9d58-4f79-8018-9e96db032371 49483-370 HUMAN OTC DRUG EXTRA PAIN RELIEF ACETAMINOPHEN, ASPIRIN AND CAFFEINE TABLET, FILM COATED ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABS ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 49483-381_b92872cb-0e33-47eb-b61f-cbeff1958a81 49483-381 HUMAN OTC DRUG Low Dose Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20100810 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/1 N 20181231 49483-382_adca4a69-3258-4604-955e-a8e3d46d102b 49483-382 HUMAN OTC DRUG ASPIRIN EXTRA STRENGTH Aspirin TABLET, COATED ORAL 20130211 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 500 mg/5001 N 20181231 49483-387_0a64066d-1a04-4fc7-afa2-cdd4a56475aa 49483-387 HUMAN OTC DRUG aspirin low dose enteric coated aspirin TABLET, COATED ORAL 20100628 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/1 N 20181231 49483-390_c94b1a7b-bd1c-4334-91f3-b43cfeb15111 49483-390 HUMAN OTC DRUG aspirin low dose enteric coated aspirin TABLET ORAL 20100716 OTC MONOGRAPH FINAL part343 Time-Cap Labs, Inc ASPIRIN 81 mg/1 N 20181231 49483-481_7262527d-45da-4bda-9420-93d64ebfc524 49483-481 HUMAN OTC DRUG LOW DOSE ASPIRIN ASPIRIN TABLET, COATED ORAL 20150619 OTC MONOGRAPH NOT FINAL part343 TIME CAP LABORATORIES, INC ASPIRIN 81 mg/1 N 20181231 49483-600_5df1b693-96f0-4b35-e053-2991aa0a3baf 49483-600 HUMAN OTC DRUG IBUPROFEN IBUPFROFEN TABLET, FILM COATED ORAL 20160322 ANDA ANDA091239 TIME CAP LABORATORIES,INC IBUPROFEN 200 mg/1 N 20181231 49483-601_5df1b693-96f0-4b35-e053-2991aa0a3baf 49483-601 HUMAN OTC DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20160322 ANDA ANDA091239 TIME CAP LABORATORIES,INC IBUPROFEN 200 mg/1 N 20181231 49483-602_815ced56-0c51-4c41-ac5a-985ca111c840 49483-602 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20151230 ANDA ANDA090796 TIME CAP LABORATORIES, INC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49483-603_815ced56-0c51-4c41-ac5a-985ca111c840 49483-603 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20151230 ANDA ANDA090796 TIME CAP LABORATORIES, INC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49483-604_815ced56-0c51-4c41-ac5a-985ca111c840 49483-604 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20151230 ANDA ANDA090796 TIME CAP LABORATORIES, INC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49483-605_d41859f2-5820-4a4e-8d1e-d9bb4d1e7c00 49483-605 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20151230 ANDA ANDA090007 TIME CAP LABORATORIES, INC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 49483-606_d41859f2-5820-4a4e-8d1e-d9bb4d1e7c00 49483-606 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20151230 ANDA ANDA090007 TIME CAP LABORATORIES, INC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 49483-607_d41859f2-5820-4a4e-8d1e-d9bb4d1e7c00 49483-607 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20151230 ANDA ANDA090007 TIME CAP LABORATORIES, INC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 49483-608_d7f321f5-7ea8-489e-9daf-7181e5e1c0a7 49483-608 HUMAN OTC DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET, FILM COATED ORAL 20160328 ANDA ANDA090545 TIME CAP LABORATORIES, INC NAPROXEN SODIUM 220 mg/1 N 20181231 49483-609_e3d9b9a9-e6a1-481c-8df0-aa3e331dcdb5 49483-609 HUMAN OTC DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET, FILM COATED ORAL 20160328 ANDA ANDA090545 TIME CAP LABORATORIES, INC NAPROXEN SODIUM 220 mg/1 N 20181231 49483-610_5e05057f-db80-0a3d-e053-2a91aa0a4a4c 49483-610 HUMAN OTC DRUG IBUPROFEN IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20151223 ANDA ANDA079205 TIME CAP LABORATORIES, INC IBUPROFEN 200 mg/1 N 20181231 49483-611_3aacf896-adf0-47fb-9cc4-a85ee9f61367 49483-611 HUMAN OTC DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20161116 ANDA ANDA091237 TIME CAP LABORATORIES,INC IBUPROFEN 200 mg/1 N 20181231 49483-612_3aacf896-adf0-47fb-9cc4-a85ee9f61367 49483-612 HUMAN OTC DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20161116 ANDA ANDA091237 TIME CAP LABORATORIES,INC IBUPROFEN 200 mg/1 N 20181231 49483-617_87b3a4df-a231-4f2f-ac84-cf5a83f1888e 49483-617 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20160706 ANDA ANDA091416 TIME CAP LABORATORIES NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49483-618_87b3a4df-a231-4f2f-ac84-cf5a83f1888e 49483-618 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20160706 ANDA ANDA091416 TIME CAP LABORATORIES NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49483-619_87b3a4df-a231-4f2f-ac84-cf5a83f1888e 49483-619 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20160706 ANDA ANDA091416 TIME CAP LABORATORIES NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49483-620_0af53553-2f64-4421-9f0a-4b03da566a4a 49483-620 HUMAN PRESCRIPTION DRUG METFORMIN HCL METFORMIN HCL TABLET, FILM COATED ORAL 20161114 ANDA ANDA090888 TIME CAP LABORATORIES, INC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 49483-621_0af53553-2f64-4421-9f0a-4b03da566a4a 49483-621 HUMAN PRESCRIPTION DRUG METFORMIN HCL METFORMIN HCL TABLET, FILM COATED ORAL 20161114 ANDA ANDA090888 TIME CAP LABORATORIES, INC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 49483-622_0af53553-2f64-4421-9f0a-4b03da566a4a 49483-622 HUMAN PRESCRIPTION DRUG METFORMIN HCL METFORMIN HCL TABLET, FILM COATED ORAL 20161114 ANDA ANDA090888 TIME CAP LABORATORIES, INC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 49483-623_5d8fff9b-7b6e-abc1-e053-2991aa0a414d 49483-623 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE EXTENDED RELEASE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20160512 ANDA ANDA090295 TIME CAP LABORATORIES, INC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 49483-624_5d8fff9b-7b6e-abc1-e053-2991aa0a414d 49483-624 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE EXTENDED RELEASE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20160512 ANDA ANDA090295 TIME CAP LABORATORIES, INC METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 49483-686_5cdc8b69-0ee1-463e-aa60-c46be88080d7 49483-686 HUMAN OTC DRUG LORATADINE LORATADINE CAPSULE, LIQUID FILLED ORAL 20161013 ANDA ANDA206214 TIME CAP LABORATORIES INC LORATADINE 10 mg/1 N 20181231 49483-687_61430400-d5a1-4b2f-af00-5f1842017293 49483-687 HUMAN PRESCRIPTION DRUG PARICALCITOL PARICALCITOL CAPSULE, LIQUID FILLED ORAL 20170103 ANDA ANDA204948 TIME CAP LABORATORIES, INC PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 49483-688_61430400-d5a1-4b2f-af00-5f1842017293 49483-688 HUMAN PRESCRIPTION DRUG PARICALCITOL PARICALCITOL CAPSULE, LIQUID FILLED ORAL 20151230 ANDA ANDA204948 TIME CAP LABORATORIES, INC PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 49483-689_61430400-d5a1-4b2f-af00-5f1842017293 49483-689 HUMAN PRESCRIPTION DRUG PARICALCITOL PARICALCITOL CAPSULE, LIQUID FILLED ORAL 20170103 ANDA ANDA204948 TIME CAP LABORATORIES, INC PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 49496-001_f78e2256-0401-413b-83dc-09b60d0684a4 49496-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100827 NDA NDA205712 American Compressed Gases Inc. OXYGEN 992 mL/L N 20181231 49502-101_23b29f26-d8e6-4e2d-b8db-49d171832e1f 49502-101 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION INTRAMUSCULAR 20161215 NDA AUTHORIZED GENERIC NDA019430 Mylan Specialty L.P. EPINEPHRINE .15 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 49502-102_23b29f26-d8e6-4e2d-b8db-49d171832e1f 49502-102 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION INTRAMUSCULAR 20161215 NDA AUTHORIZED GENERIC NDA019430 Mylan Specialty L.P. EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 49502-420_3b7ab092-6ab9-41b7-b9db-0593b81b8edf 49502-420 HUMAN PRESCRIPTION DRUG Eldepryl selegiline hydrochloride CAPSULE ORAL 19960515 NDA NDA020647 Mylan Specialty L.P. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 49502-500_46c3c47e-95a9-42ec-94fd-69687bbf88ff 49502-500 HUMAN PRESCRIPTION DRUG EPIPEN epinephrine INJECTION INTRAMUSCULAR 19871222 NDA NDA019430 Mylan Specialty L.P. EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 49502-501_46c3c47e-95a9-42ec-94fd-69687bbf88ff 49502-501 HUMAN PRESCRIPTION DRUG EPIPEN JR epinephrine INJECTION INTRAMUSCULAR 19871222 NDA NDA019430 Mylan Specialty L.P. EPINEPHRINE .15 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 49502-605_a91f925c-144d-430c-ab35-8e982e066159 49502-605 HUMAN PRESCRIPTION DRUG Perforomist formoterol fumarate dihydrate SOLUTION RESPIRATORY (INHALATION) 20071001 NDA NDA022007 Mylan Specialty L.P. FORMOTEROL FUMARATE 20 ug/2mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 49502-900_5e530449-b3e9-4f49-a15d-a86e30a65c3c 49502-900 HUMAN PRESCRIPTION DRUG EMSAM selegiline PATCH TRANSDERMAL 20060227 NDA NDA021336 Mylan Specialty L.P. SELEGILINE 6 mg/24h Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 49502-901_5e530449-b3e9-4f49-a15d-a86e30a65c3c 49502-901 HUMAN PRESCRIPTION DRUG EMSAM selegiline PATCH TRANSDERMAL 20060227 NDA NDA021336 Mylan Specialty L.P. SELEGILINE 9 mg/24h Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 49502-902_5e530449-b3e9-4f49-a15d-a86e30a65c3c 49502-902 HUMAN PRESCRIPTION DRUG EMSAM selegiline PATCH TRANSDERMAL 20060227 NDA NDA021336 Mylan Specialty L.P. SELEGILINE 12 mg/24h Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 49507-001_64902b20-ba13-4a47-ae0b-61373e62f9e0 49507-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19770101 NDA NDA206023 Hagan, Logan Welding Supply Inc OXYGEN 995 mL/L N 20181231 49514-051_4ec32445-4496-420d-a9aa-797f4bbd297e 49514-051 HUMAN OTC DRUG BRIGHTON PROFESSIONAL Antibacterial Hand So ap Chloroxylenol LIQUID TOPICAL 20060430 OTC MONOGRAPH NOT FINAL part333E Staples CHLOROXYLENOL .003 mg/mL N 20181231 49514-075_f37ccdca-151e-4700-9c08-7d379cf02102 49514-075 HUMAN OTC DRUG Staples Instant Hand Sanitizer Alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Staples ALCOHOL 62 mL/100mL E 20171231 49514-076_06cec0fe-2b11-47b6-beb5-38cb9ae9da68 49514-076 HUMAN OTC DRUG Staples Instant Hand Sanitizer Alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Staples ALCOHOL 62 mL/100mL E 20171231 49514-080_f4398700-81d1-43e3-908d-8f0eb0376fcf 49514-080 HUMAN OTC DRUG BRIGHTON PROFESSIONAL Antibacterial Foaming Hand So ap Chloroxylenol LIQUID TOPICAL 20060530 OTC MONOGRAPH NOT FINAL part333E Staples CHLOROXYLENOL .003 mg/mL N 20181231 49514-081_ca29b8c4-82ba-45e2-8247-cbf897bddd43 49514-081 HUMAN OTC DRUG BRIGHTON PROFESSIONAL Premium Antibacterial Foam So ap Chloroxylenol LIQUID TOPICAL 20070330 OTC MONOGRAPH NOT FINAL part333E Staples CHLOROXYLENOL .003 mg/mL N 20181231 49514-200_e431a7b9-1565-49ec-9e2d-34d8bce94556 49514-200 HUMAN OTC DRUG STAPLES Hand Sanitizer alcohol GEL TOPICAL 20150330 OTC MONOGRAPH NOT FINAL part333E Staples ALCOHOL .7 mL/mL N 20181231 49514-250_070eb7c6-06c5-4d94-9142-28e1f69f06ee 49514-250 HUMAN OTC DRUG STAPLES Hand Sanitizer Aloe ALCOHOL LIQUID TOPICAL 20150330 OTC MONOGRAPH NOT FINAL part333E Staples ALCOHOL .7 mL/mL N 20181231 49514-253_3d972999-0568-6b4c-e054-00144ff8d46c 49514-253 HUMAN OTC DRUG Antiseptic Hand Sanitizer ALCOHOL SPRAY TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333A Staples the Office Superstore, LLC ALCOHOL 62 mL/100mL E 20171231 49514-400_e82c81b7-f0a2-4f20-9df6-8e5976610afb 49514-400 HUMAN OTC DRUG BRIGHTON PROFESSIONAL Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Staples BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 49514-472_7a3a1f1b-8fcd-4e8b-99f8-0b98f4b0e4d5 49514-472 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160616 OTC MONOGRAPH NOT FINAL part333A Staples the Office Superstore, LLC ALCOHOL 545 mg/mL N 20181231 49517-0001_67c282fa-4c45-42f5-80df-be34cac4f76b 49517-0001 HUMAN OTC DRUG Sayuki Broad Spectrum SPF 30 Anti-Aging Daily Moisturizer Sunscreen AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120419 OTC MONOGRAPH FINAL part352 Sayuki Custom Cosmetics AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49520-101_3985a28f-9688-405e-ac32-602c06f45d9c 49520-101 HUMAN OTC DRUG OBLITERATE BENZOYL PEROXIDE LOTION TOPICAL 20120424 OTC MONOGRAPH FINAL part333D mybody BENZOYL PEROXIDE 5 g/100mL E 20171231 49520-102_e3393b63-1dbc-4c50-b114-da74582319f5 49520-102 HUMAN OTC DRUG myHELPER BENZOYL PEROXIDE CREAM TOPICAL 20120424 OTC MONOGRAPH FINAL part333D mybody BENZOYL PEROXIDE 5 g/100mL E 20171231 49520-103_f646e74c-7e69-4992-b8d2-0e9661930c82 49520-103 HUMAN OTC DRUG LET ME CLARIFY SALICYLIC ACID GEL TOPICAL 20120924 OTC MONOGRAPH FINAL part333D mybody SALICYLIC ACID 2 g/100mL E 20171231 49520-104_75ca949f-d649-4a76-8543-58c5e94daa0a 49520-104 HUMAN OTC DRUG TAKE CONTROL CALMING CLEANSER SALICYLIC ACID GEL TOPICAL 20120927 OTC MONOGRAPH FINAL part333D mybody SALICYLIC ACID 2 g/100mL E 20171231 49520-201_f4775a0b-f209-4591-9d3b-c84c95d6be5c 49520-201 HUMAN OTC DRUG LIGHT THE WAY HYDROQUINONE LOTION TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part358A mybody HYDROQUINONE 2 g/100mL E 20171231 49520-301_9e7a0fcb-b887-45d1-9644-dd51021c2ea3 49520-301 HUMAN OTC DRUG PROTECT AND SERVE TINTED SUN SHIELD SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE LOTION TOPICAL 20120923 OTC MONOGRAPH NOT FINAL part352 mybody TITANIUM DIOXIDE; ZINC OXIDE 11; 4 g/100mL; g/100mL E 20171231 49520-302_b09bf60f-15c1-44bf-9511-7aa909ed075c 49520-302 HUMAN OTC DRUG myBody PROTECT AND SERVE SPF-30 ZINC OXIDE LOTION TOPICAL 20150903 OTC MONOGRAPH NOT FINAL part352 mybody TITANIUM DIOXIDE; ZINC OXIDE 11; 4 g/100mL; g/100mL E 20171231 49520-501_32bcb76e-21f4-4c81-9604-225e549314a7 49520-501 HUMAN OTC DRUG ERASE IT KIT SALICYLIC ACID, TITANIUM DIOXIDE, ZINC OXIDE KIT 20140510 OTC MONOGRAPH FINAL part333D mybody E 20171231 49520-502_10847989-96c6-427a-82d3-1ac9121c4beb 49520-502 HUMAN OTC DRUG CALM IT DOWN KIT TITANIUM DIOXIDE, ZINC OXIDE KIT 20140510 OTC MONOGRAPH FINAL part352 mybody E 20171231 49520-503_c1930042-d8a9-4265-bdce-7cbdd3ea4e26 49520-503 HUMAN OTC DRUG REVERSE IT KIT TITANIUM DIOXIDE, ZINC OXIDE KIT 20140510 OTC MONOGRAPH FINAL part352 mybody E 20171231 49523-501_f416a05d-3253-49de-9688-4b652315cae5 49523-501 HUMAN OTC DRUG Baczol Expectorant GUAIFENESIN and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20130204 OTC MONOGRAPH FINAL part341 Lex Inc GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 200; 5 mg/5mL; mg/5mL E 20171231 49523-505_25259b06-cfdb-4497-8a12-a27a0a0f65dd 49523-505 HUMAN OTC DRUG Baczol Cold Medicine ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, and CHLORPHENIRAMINE MALEATE LIQUID ORAL 20130204 OTC MONOGRAPH FINAL part341 Lex Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE 250; 10; 10; 4 mg/5mL; mg/5mL; mg/5mL; mg/5mL E 20171231 49527-001_5eb8ad12-afba-474e-95b1-f9b3bcfe8d76 49527-001 HUMAN OTC DRUG CITY STICK SPF 15 TITANIUM DIOXIDE STICK TOPICAL 19990501 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE 4 g/100g E 20171231 49527-002_30758c13-7195-4d93-840c-563fc8577a1a 49527-002 HUMAN OTC DRUG ALMOST MAKEUP SPF 15 TITANIUM DIOXIDE LIQUID TOPICAL 19980102 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE 45 mL/100mL E 20171231 49527-003_4d21b548-1986-4bc2-bfbe-c66cae33e9b8 49527-003 HUMAN OTC DRUG CLINIQUE SKIN SUPPLIES FOR MEN AGE DEFENSE HYDRATOR SPF 15 octinoxate, octisalate, avobenzone LOTION TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 2 mL/100mL; mL/100mL; mL/100mL N 20181231 49527-005_651ed07d-d801-458b-bb84-3ca903a55303 49527-005 HUMAN OTC DRUG REDNESS SOLUTIONS MAKEUP SPF 15 WITH PROBIOTIC TECHNOLOGY OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 5.9; 3.7; 2.9 mL/100mL; mL/100mL; mL/100mL N 20181231 49527-006_64471e3b-3e02-4085-b456-7f3a76da27df 49527-006 HUMAN OTC DRUG CLINIQUE CLARIFYING MAKEUP SALICYLIC ACID POWDER TOPICAL 20101001 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC SALICYLIC ACID .5 g/100g N 20181231 49527-007_bdbcc35e-1e60-4bf4-818e-c44dd90e841c 49527-007 HUMAN OTC DRUG MOISTURE SURGE TINTED MOISTURIZER SPF 15 TITANIUM DIOXIDE, OCTISALATE, OCTINOXATE LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE; OCTISALATE; OCTINOXATE 6.8; 5; 2.8 mL/100mL; mL/100mL; mL/100mL E 20171231 49527-008_ff0d1114-24c2-4367-a60d-b1e144649925 49527-008 HUMAN OTC DRUG DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABS INC OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 7.5; 5.2; 2 mL/100mL; mL/100mL; mL/100mL N 20181231 49527-009_c6e53627-bd4a-4f91-8fdc-594b686f07c8 49527-009 HUMAN OTC DRUG REPAIRWEAR LIFT SPF 15 FIRMING DAY COMBO TO OILY SKIN OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; TITANIUM DIOXIDE 7.5; 1.4 mL/100mL; mL/100mL E 20171231 49527-010_57a20355-aa90-462f-b51e-68616a1a555d 49527-010 HUMAN OTC DRUG CONTINUOUS COVERAGE MAKEUP SPF 15 TITANIUM DIOXIDE CREAM TOPICAL 19920101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE 2 mL/100mL N 20181231 49527-011_5a4c19e1-4570-4b11-abad-36b19cd16c35 49527-011 HUMAN OTC DRUG REPAIRWEAR LASERFOCUS ALL SMOOTH MAKEUP SPF 15 TITANIUM DIOXIDE, OCTOCRYLENE LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE; OCTOCRYLENE 2.9; 2 mL/100mL; mL/100mL N 20181231 49527-013_852f2307-d92a-4149-acb8-b09fc712490f 49527-013 HUMAN OTC DRUG EVEN BETTER DARK SPOT CORRECTING BROAD SPECTRUM SPF 15 AVOBENZONE, HOMOSALATE, and OCTISALATE CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC AVOBENZONE; HOMOSALATE; OCTISALATE .03; .03; .05 g/mL; g/mL; g/mL N 20181231 49527-014_8efb261e-c071-4029-863e-b60335b75899 49527-014 HUMAN OTC DRUG CLINIQUE REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY COMBO OILY OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 3.5; 1.7 mL/100mL; mL/100mL; mL/100mL N 20181231 49527-015_b0611de3-4a29-4f8c-ae39-d9a383bb15df 49527-015 HUMAN OTC DRUG CITY BASE COMPACT FOUNDATION SPF 15 TITANIUM DIOXIDE PASTE TOPICAL 19981001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE 5.8 g/100g E 20171231 49527-017_7972ff02-09c1-4863-9584-ba736f84a978 49527-017 HUMAN OTC DRUG REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 3.5; 1.7 mL/100mL; mL/100mL; mL/100mL N 20181231 49527-018_92d5f660-b3ce-4123-bd39-c763f59311cd 49527-018 HUMAN OTC DRUG EVEN BETTER COMPACT MAKEUP BROAD SPECTRUM SPF15 TITANIUM DIOXIDE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE 3.8 g/100g N 20181231 49527-022_f7640d95-e749-44c8-b826-5543f51414f4 49527-022 HUMAN OTC DRUG REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION OILY OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .078; .0364; .0176 g/mL; g/mL; g/mL N 20181231 49527-025_b358fe4d-5e3d-4ab1-bebf-f13d4bd891e0 49527-025 HUMAN OTC DRUG EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .06962; .0412; .033 g/mL; g/mL; g/mL N 20181231 49527-027_d3e7b8b6-a77a-4249-9820-306e70e8fffa 49527-027 HUMAN OTC DRUG EVEN BETTER SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM SPF 20 AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTISALATE; OCTOCRYLENE .0303; .0505; .2727 g/mL; g/mL; g/mL N 20181231 49527-028_bcbeaf06-aeb0-49b3-8127-2e93776eca9a 49527-028 HUMAN OTC DRUG MOISTURE SURGE CC BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .08175; .0555; .5772; .0355 g/mL; g/mL; g/mL; g/mL N 20181231 49527-030_975f3b26-3ebb-4615-8407-9752166040d8 49527-030 HUMAN OTC DRUG AGE DEFENSE BB BROAD SPECTRUM SPF 30 ALL SKIN TYPES OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .084375; .0495; .039375; .02475 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 49527-034_0eaa9753-0cc1-4a16-9c93-4242086acbfe 49527-034 HUMAN OTC DRUG SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 VERY DRY TO DRY OCTISALATE, OXYBENZONE, and AVOBENZONE CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTISALATE; OXYBENZONE; AVOBENZONE .0508; .0508; .0305 g/mL; g/mL; g/mL E 20171231 49527-035_f28af51c-2628-45c9-b1c4-68341157bd53 49527-035 HUMAN OTC DRUG CLINIQUE SKIN SUPPLIES FOR MEN AGE DEFENSE HYDRATOR BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, and OCTISALATE LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTINOXATE; OCTISALATE .0203; .076; .0507 g/mL; g/mL; g/mL E 20171231 49527-036_1d09711f-7990-4c85-8f75-82ff33e34aaa 49527-036 HUMAN OTC DRUG SUPERDEFENSE AGE DEFENSE BROAD SPECTRUM SPF 20 TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE; ZINC OXIDE .060217; .040861 g/100mL; g/100mL N 20181231 49527-037_9845e0c1-55a0-4c30-83e7-35f5fd3c4094 49527-037 HUMAN OTC DRUG SUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (COMBINATION OILY - OILY) AVOBENZONE and OCTISALATE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTISALATE .03; .05 g/mL; g/mL N 20181231 49527-039_4a3b55c9-4e14-45a6-ba1f-fe327a9f873d 49527-039 HUMAN OTC DRUG SUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (VERY DRY - DRY COMB) AVOBENZONE and OCTISALATE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTISALATE .03; .05 g/mL; g/mL N 20181231 49527-040_89519e46-d9ca-47ba-b53f-6692d53d59ba 49527-040 HUMAN OTC DRUG CLINIQUE MOISTURE SURGE CC COMPACT HYDRATING COLOUR CORRECTOR BROAD SPECTRUM SPF 25 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; TITANIUM DIOXIDE 5.5; 4.7 g/100g; g/100g N 20181231 49527-041_a317d9aa-c479-4f2b-b15f-64eb5f33f3af 49527-041 HUMAN OTC DRUG CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN HOMOSALATE, OCTISALATE, and AVOBENZONE STICK TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. HOMOSALATE; OCTISALATE; AVOBENZONE 5; 5; 3 g/100g; g/100g; g/100g N 20181231 49527-044_4bdf0a21-865e-469a-94ec-70368f1d774d 49527-044 HUMAN OTC DRUG ACNE BB BROAD SPECTRUM SPF 40 OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE CREAM TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .08175; .0218; .01744 g/100mL; g/100mL; g/100mL N 20181231 49527-045_9e8d729b-4e14-4eac-8dbe-f0cf7d91de36 49527-045 HUMAN OTC DRUG ACNE CLEANSING SALICYLIC ACID GEL TOPICAL 20141001 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC. SALICYLIC ACID .02158 g/100mL N 20181231 49527-046_ec740f94-c1a0-427b-bbb7-593ed36ef048 49527-046 HUMAN OTC DRUG CLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 titanium dioxide and zinc oxide LOTION TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE; ZINC OXIDE .06696; .0432 g/100mL; g/100mL N 20181231 49527-047_dbf208b4-bd01-47be-8248-920206746c02 49527-047 HUMAN OTC DRUG SUPER CITY BLOCK BB CUSHION COMPACT BROAD SPECTRUM SPF 50 Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE; ZINC OXIDE 7.6; 5.1 g/100g; g/100g N 20181231 49527-048_7ff94cd7-02f6-4dac-955c-8b1cd625ca1c 49527-048 HUMAN OTC DRUG CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRY AVOBENZONE and OCTISALATE CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTISALATE .03015; .05025 g/100mL; g/100mL N 20181231 49527-049_36cc4d92-fdbe-49dd-b9f0-ce34dd43f82b 49527-049 HUMAN OTC DRUG REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATION OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .076125; .03745; .015225 g/100mL; g/100mL; g/100mL N 20181231 49527-050_207b96b1-98f2-41a7-810b-b33f684e74f2 49527-050 HUMAN OTC DRUG CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILY AVOBENZONE and OCTISALATE CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTISALATE 30; 50 mg/mL; mg/mL N 20181231 49527-052_0877fd82-73dd-4b7e-ad8c-bb9b71dbeb6f 49527-052 HUMAN OTC DRUG CLINIQUE SUPERBALANCED SILK MAKEUP BROAD SPECTRUM SPF 15 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20160715 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .077; .05; .085; .021 g/mL; g/mL; g/mL; g/mL N 20181231 49527-053_c9297200-50a3-4e27-9c95-ad9b0ad7c6ff 49527-053 HUMAN OTC DRUG ACNE AND LINE CORRECTING SERUM SALICYLIC ACID LOTION TOPICAL 20160815 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC. SALICYLIC ACID 10 mg/mL N 20181231 49527-054_7c89043b-6135-4e00-8c10-c450cd0cad75 49527-054 HUMAN OTC DRUG PEP START HYDRORUSH MOISTURIZER BROAD SPECTRUM SPF 20 AVOBENZONE and OCTISALATE CREAM TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. AVOBENZONE; OCTISALATE 30; 50 mg/mL; mg/mL N 20181231 49527-055_24722136-75f0-41ec-86b7-c07b29f84e38 49527-055 HUMAN OTC DRUG CLINIQUE FIT WORKOUT MAKEUP BROAD SPECTRUM SPF 40 OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE CREAM TOPICAL 20170215 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .08175; .0218; .01744 g/100mL; g/100mL; g/100mL N 20181231 49527-056_a44d2ee2-9350-4fd6-819b-099ac2c647c5 49527-056 HUMAN OTC DRUG EVEN BETTER GLOW LIGHT REFLECTING MAKEUP BROAD SPECTRUM SPF 15 Octinoxate, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170320 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .0675; .04275; .03375 g/mL; g/mL; g/mL N 20181231 49527-057_8808bc27-c692-4844-b817-ca4d70c0ca01 49527-057 HUMAN OTC DRUG CLINIQUE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN FLUID FOR FACE titanium dioxide and zinc oxide LIQUID TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE; ZINC OXIDE .032; .02 g/mL; g/mL N 20181231 49527-058_fa601cde-755a-4bd5-bb7f-ff3613648bfa 49527-058 HUMAN OTC DRUG CLINIQUE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN FOR BODY titanium dioxide and zinc oxide LIQUID TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE; ZINC OXIDE .032; .02 g/mL; g/mL N 20181231 49527-112_2cfb7096-0a73-4e39-838b-8024d1b2926f 49527-112 HUMAN OTC DRUG CLINIQUE EVEN BETTER SKIN TONE CORRECTING BROAD SPECTRUM SPF 20 OCTISALATE, AVOBENZONE, and OCTOCRYLENE LOTION TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTISALATE; AVOBENZONE; OCTOCRYLENE 5; 3; 2.7 mL/100mL; mL/100mL; mL/100mL N 20181231 49527-571_a9d2ee62-41fe-45b6-a93e-e00b93c818a6 49527-571 HUMAN OTC DRUG CLINIQUE ANTIPERSPIRANT DEODORANT ROLL-ON ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 19921201 OTC MONOGRAPH FINAL part350 CLINIQUE LABORATORIES INC ALUMINUM CHLOROHYDRATE 70 mL/100mL N 20181231 49527-706_f11115d4-0d4f-49b6-a44b-ea4c8d022b78 49527-706 HUMAN OTC DRUG SKIN SUPPLIES FOR MEN ANTIPERSPIRANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY CREAM TOPICAL 19840401 OTC MONOGRAPH FINAL part350 CLINIQUE LABORATORIES INC. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.6 g/100g N 20181231 49527-707_df1d5fe1-1708-49e2-a9cd-5a473c822202 49527-707 HUMAN OTC DRUG SUPER DEFENSE SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 DRY COMBINATION OXYBENZONE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OXYBENZONE; OCTISALATE; AVOBENZONE 5; 5; 3 mL/100mL; mL/100mL; mL/100mL E 20171231 49527-708_169e5628-2a40-429c-9bf8-cf24ce3fb9eb 49527-708 HUMAN OTC DRUG SUPER DEFENSE SUPERDEFENSE AGE DEFENSE MOISTURIZER SPF 25 VERY DRY SKIN OXYBENZONE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OXYBENZONE; OCTISALATE; AVOBENZONE 5; 5; 3 mL/100mL; mL/100mL; mL/100mL E 20171231 49527-709_1699bc81-2bf7-4cdb-a19e-708dfa2f32d3 49527-709 HUMAN OTC DRUG CLINIQUE SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 AVOBENZONE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20040401 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 1.3; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49527-712_c354f9e8-101b-43e7-a06f-016bbfb6fb8c 49527-712 HUMAN OTC DRUG EVEN BETTER MAKEUP SPF 15 EVENS AND CORRECTS OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE LIQUID TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 6; 3.5; 2.9 mL/100mL; mL/100mL; mL/100mL E 20171231 49527-713_53f99ad0-776f-4fac-8a26-187a23321618 49527-713 HUMAN OTC DRUG ACNE SOLUTIONS OIL CONTROL CLEANSING MASK ACNE MEDICATION ALL SKIN TYPES SALICYLIC ACID CREAM TOPICAL 20070901 OTC MONOGRAPH FINAL part333 CLINIQUE LABORATORIES INC SALICYLIC ACID 1 mL/100mL N 20181231 49527-715_1030d397-237f-4a31-bc1d-04ecece86aca 49527-715 HUMAN OTC DRUG Skin Supplies for Men antiperspirant Clinique Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20120223 OTC MONOGRAPH FINAL part350 CLINIQUE LABORATORIES INC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.6 g/100mL N 20181231 49527-716_7a0ac6b2-61f0-47f2-bbeb-f6e50830d2b2 49527-716 HUMAN OTC DRUG CLINIQUE SPF 30 with SOLAR SMART octisalate, homosalate, oxybenzone, avobenzone, and octocrylene CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTISALATE; HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 5; 5; 4; 3; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49527-717_ed67f891-45eb-4ce2-a39e-91d71ec741a8 49527-717 HUMAN OTC DRUG SPF 50 with SOLAR SMART oxybenzone, octisalate, homosalate, avobenzone, and octocrylene CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OXYBENZONE; OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE 5; 5; 5; 3; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49527-718_8becbebb-d1e3-45aa-8a1f-43d5de0afc99 49527-718 HUMAN OTC DRUG ACNE SOLUTIONS EMERGENCY BENZOYL PEROXIDE LOTION TOPICAL 20001201 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC BENZOYL PEROXIDE 2.5 mL/100mL N 20181231 49527-719_f887bd06-097b-4391-b4e4-68c1ce76cdd6 49527-719 HUMAN OTC DRUG REPAIRWEAR LIFT SPF 15 FIRMING DAY DRY COMBO SKIN OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 3.5; 1 mL/100mL; mL/100mL; mL/100mL E 20171231 49527-722_f22e64e9-8b07-4af1-9bbc-1978bf835562 49527-722 HUMAN OTC DRUG CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE; ZINC OXIDE 6.4; 2 mL/100mL; mL/100mL N 20181231 49527-723_af89f625-9d44-4263-920e-a7c5b7e9c217 49527-723 HUMAN OTC DRUG ACNE SOLUTIONS CLARIFYING SALICYLIC ACID LIQUID TOPICAL 20060901 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC SALICYLIC ACID 1.5 mL/100mL N 20181231 49527-724_8e5070fa-9ca7-4907-8136-da89d9c931dc 49527-724 HUMAN OTC DRUG ALMOST POWDER COMPACT MAKEUP SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE 6.9 g/100g N 20181231 49527-727_147dcb1b-5838-4dd9-804a-b9f34a1db9fc 49527-727 HUMAN OTC DRUG HIGH IMPACT LIP COLOUR SPF 15 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; ZINC OXIDE 7.5; 2.1 g/100g; g/100g E 20171231 49527-730_5759b0af-ab98-41ce-ac9f-9725d5788e26 49527-730 HUMAN OTC DRUG YOUTH SURGE SPF 15 AGE DECELERATING MOISTURIZER DRY COMBINATION SKIN OCTINOXATE OCTISALATE TITANIUM DIOXIDE CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.5; 3.5; 1.2 mL/100mL; mL/100mL; mL/100mL E 20171231 49527-731_11e55ace-e2c9-4c6d-b9ff-80c9ca3e4c1c 49527-731 HUMAN OTC DRUG YOUTH SURGE SPF 15 AGE DECELERATING MOISTURIZER ANTI RIDES HYDRATANT OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20090224 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; TITANIUM DIOXIDE 7.5; 1.4 mL/100mL; mL/100mL E 20171231 49527-732_04e85925-302f-4bb0-af4d-13ba7ed29e1b 49527-732 HUMAN OTC DRUG YOUTH SURGE AGE DECELERATING MOISTURIZER SPF 15 octisalate, avobenzone, octocrylene, and homosalate CREAM TOPICAL 20080301 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE 5; 3; 2.7; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 49527-734_ea862b96-2ee9-4a7a-81d9-3b7d88ab25e9 49527-734 HUMAN OTC DRUG CLINIQUE SPF 50 with SOLAR SMART ADVANCED PROTECTION oxybenzone, octisalate, homosalate, avobenzone, and octocrylene CREAM TOPICAL 20090302 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OXYBENZONE; OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE 5; 5; 5; 3; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49527-735_ccaf35c2-e800-4f09-9881-55decb422123 49527-735 HUMAN OTC DRUG CLINIQUE SPF 15 with SOLAR SMART ADVANCED PROTECTION homosalate, octisalate, avobenzone, and octocrylene CREAM TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 10; 5; 3; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 49527-736_dfbb4a0f-2878-48b2-b2d6-96c58c877f14 49527-736 HUMAN OTC DRUG CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM with SOLAR SMART octisalate, homosalate, oxybenzone, avobenzone, octocrylene CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABS INC OCTISALATE; HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 5; 5; 4; 3; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49527-743_cf9c4903-54d0-44ad-90a3-f61b6e78cbb2 49527-743 HUMAN OTC DRUG LONG LAST GLOSSWEAR SPF 15 OCTINOXATE, OCTISALATE LIQUID TOPICAL 20080301 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE 7.5; 4 mL/100mL; mL/100mL E 20171231 49527-746_2d8f51b5-b51b-47f3-b07d-de1345ea4990 49527-746 HUMAN OTC DRUG SUPERBALANCED MAKEUP SPF 15 MINERAL RICH FORMULA TITANIUM DIOXIDE POWDER TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE 6.3 g/100g N 20181231 49527-749_8cfbc730-2097-4261-9011-1c76ba1a31a3 49527-749 HUMAN OTC DRUG ACNE SOLUTIONS CLEARING CONCEALER ACNE MEDICATION ALL SKIN TYPES SALICYLIC ACID LOTION TOPICAL 20080402 OTC MONOGRAPH FINAL part333 CLINIQUE LABORATORIES INC SALICYLIC ACID 1 mL/100mL N 20181231 49527-750_99eda414-2647-4c41-8deb-7bf2b99141be 49527-750 HUMAN OTC DRUG CX DAILY EYE PROTECTOR SPF 15 TITANIUM DIOXIDE GEL TOPICAL 20020201 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE 7.8 mL/100mL E 20171231 49527-751_c31f35a5-ba3d-4b6e-8c2b-9fb47f952084 49527-751 HUMAN OTC DRUG ACNE SOLUTIONS LIQUID MAKEUP SALICYLIC ACID ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20090409 OTC MONOGRAPH FINAL part333 CLINIQUE LABORATORIES INC SALICYLIC ACID .5 mL/100mL N 20181231 49527-752_5c3328c6-436b-4f1d-bc12-ac9374003855 49527-752 HUMAN OTC DRUG CLINIQUE SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN FLUID FOR FACE TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE; ZINC OXIDE 66.46; 42.2 mg/mL; mg/mL N 20181231 49527-759_1a87f014-4fd5-4ba5-9a47-a8276815f6d2 49527-759 HUMAN OTC DRUG EVEN BETTER SKIN TONE CORRECTING MOSTURIZER SPF 20 OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20090801 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES, INC. OCTISALATE; AVOBENZONE; OCTOCRYLENE 5; 3; 2.7 mL/100mL; mL/100mL; mL/100mL N 20181231 49527-760_6d32bd57-878f-461d-b31c-30d42da77028 49527-760 HUMAN OTC DRUG Age Defense BB Cream SPF 30 OCTINOXATE, OCTISALATE, ZINC OXIDE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20100823 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 4; 3.5; 2.5; 1.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 49527-800_9d821a45-3ceb-4b8c-a58c-08dc973fb934 49527-800 HUMAN OTC DRUG ALMOST POWDER MAKEUP SPF 15 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC TITANIUM DIOXIDE; OCTINOXATE 13; 2 g/100g; g/100g N 20181231 49527-801_ac87746b-ecb8-4446-a496-6f00d91cf549 49527-801 HUMAN OTC DRUG almost bronzer spf 15 titanium dioxide POWDER TOPICAL 20010901 OTC MONOGRAPH NOT FINAL part352 clinique laboratories inc TITANIUM DIOXIDE 9.8 g/100g E 20171231 49527-802_6bf4ae0a-983c-4053-8a2c-3de94b836438 49527-802 HUMAN OTC DRUG ALMOST MAKEUP BROAD SPECTRUM SPF 15 TITANIUM DIOXIDE and OCTINOXATE POWDER TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE; OCTINOXATE 13; 2 g/100g; g/100g N 20181231 49527-825_8583e169-abb4-4ffb-92a7-7864b7538d6d 49527-825 HUMAN OTC DRUG ACNE SOLUTIONS SPOT HEALING ACNE MEDICATION SALICYLIC ACID GEL TOPICAL 20081201 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC SALICYLIC ACID .5 mL/100mL N 20181231 49527-886_35c7c68e-924c-487c-bdd9-be60717eb96a 49527-886 HUMAN OTC DRUG CLINIQUE skin supplies for men octinoxate, octisalate, avobenzone, and oxybenzone LOTION TOPICAL 20040901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. OCTINOXATE; OCTISALATE; AVOBENZONE; OXYBENZONE 7.4; 5; 3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49527-920_e4f4efa2-ee46-4b31-9339-525ae422a616 49527-920 HUMAN OTC DRUG REPAIRWEAR ANTI -AGING MAKEUP SPF 15 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20050621 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE; ZINC OXIDE 12.6; 2 mL/100mL; mL/100mL E 20171231 49527-942_9df7e655-0bff-4fab-8de4-7c5ec0b053fb 49527-942 HUMAN OTC DRUG SUPER CITY BLOCK SPF 40 OIL FREE DAILY FACE PROTECTOR zinc oxide, octinoxate, titanium dioxide, and octisalate CREAM TOPICAL 20040901 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 8.8; 7.5; 6.6; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49527-953_3db07dee-3ef4-417d-a4ac-1a18421ddcb4 49527-953 HUMAN OTC DRUG CLINIQUE CX PROTECTIVE BASE SPF 40 OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE CREAM TOPICAL 20050501 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 7.5; 5; 4.6; 1.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49527-989_da7f4dee-33bc-4add-a1ba-821bd8e31644 49527-989 HUMAN OTC DRUG CITY BLOCK SHEER SPF 25 OIL FREE DAILY FACE PROTECTOR TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part352 CLINIQUE LABORATORIES INC. TITANIUM DIOXIDE; ZINC OXIDE 7.3; 6.9 mL/100mL; mL/100mL N 20181231 49527-992_e85134d9-61c5-4388-9e47-b0ad7e44a357 49527-992 HUMAN OTC DRUG ACNE SOLUTIONS CLEANSING FOAM salicylic acid LIQUID TOPICAL 20061212 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC SALICYLIC ACID 2 mL/100mL N 20181231 49527-997_1d66e5cd-35ee-41e6-b39b-bcb45a7a275f 49527-997 HUMAN OTC DRUG ACNE SOLUTIONS CLEARING MOISTURIZER ACNE MEDICATION BENZOYL PEROXIDE LOTION TOPICAL 20060901 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC BENZOYL PEROXIDE 2.5 mL/100mL N 20181231 49527-999_7747fb7f-1580-4b67-9ead-01b6c19cd5f4 49527-999 HUMAN OTC DRUG ACNE SOLUTIONS CLEANSING BAR FOR FACE AND BODY salicylic acid SOAP TOPICAL 20060401 OTC MONOGRAPH FINAL part333D CLINIQUE LABORATORIES INC SALICYLIC ACID 2 g/100g N 20181231 49543-738_38497a7a-2859-4b3e-b4df-2fb3ac34e4fc 49543-738 HUMAN OTC DRUG Hansan Spray ALCOHOL LIQUID TOPICAL 20091231 OTC MONOGRAPH NOT FINAL part333 Nexgen ALCOHOL .7 mL/mL E 20171231 49543-773_e755d227-f275-4f93-b7f4-79964d464f1c 49543-773 HUMAN OTC DRUG Hansan Foam ALCOHOL AEROSOL, FOAM TOPICAL 20091231 OTC MONOGRAPH NOT FINAL part333 Nexgen ALCOHOL 620 mg/g E 20171231 49543-783_5d1393c7-4ec7-4b19-9399-fc80a0e80081 49543-783 HUMAN OTC DRUG Hand Sanitizer Wipes ALCOHOL CLOTH TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part333E Nexgen ALCOHOL 620 mg/g N 20181231 49546-105_6154b5de-86a7-9252-e053-2991aa0ad345 49546-105 HUMAN OTC DRUG Ivy-Dry Super BENZYL ALCOHOL, CAMPHOR, MENTHOL SPRAY TOPICAL 20120711 OTC MONOGRAPH NOT FINAL part348 Ivy-Dry, Inc. BENZYL ALCOHOL; CAMPHOR (SYNTHETIC); MENTHOL 100; 5; 2.5 mg/mL; mg/mL; mg/mL N 20181231 49546-106_09f9480f-f2e7-4275-afe3-001676e6a826 49546-106 HUMAN OTC DRUG Ivy-Dry Super BENZYL ALCOHOL, CAMPHOR, MENTHOL SPRAY TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part348 Ivy-Dry, Inc. BENZYL ALCOHOL; CAMPHOR (SYNTHETIC); MENTHOL 10; .5; .25 mL/100mL; mL/100mL; mL/100mL E 20171231 49546-201_4b4d2721-d863-4065-92a5-723d9dd218f6 49546-201 HUMAN OTC DRUG Ivy Dry Benzyl Alcohol, Camphor, Menthol CREAM TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part348 Ivy Dry, Inc. BENZYL ALCOHOL; CAMPHOR (SYNTHETIC); MENTHOL 10; .6; .4 g/100g; g/100g; g/100g N 20181231 49557-221_1a602bf9-674c-4705-bb9b-91f6dd1b6b4a 49557-221 HUMAN OTC DRUG High Five ALCOHOL GEL TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part333E Jani-Source, LLC ALCOHOL .7 mL/mL N 20181231 49557-572_832c4566-d2e7-41d7-81be-5d6f663d9568 49557-572 HUMAN OTC DRUG High Five TRICLOSAN SOAP TOPICAL 20120425 OTC MONOGRAPH NOT FINAL part333E Jani-Source, LLC TRICLOSAN 3 mg/mL E 20171231 49557-575_82fbbdb6-a80c-4da0-b281-82aaa78e6cd6 49557-575 HUMAN OTC DRUG High Five BENZETHONIUM CHLORIDE LIQUID TOPICAL 20160224 OTC MONOGRAPH NOT FINAL part333E Jani-Source, LLC BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 49557-576_f7622198-fdd4-4157-a8ef-c26abd924e1d 49557-576 HUMAN OTC DRUG Foaming Antimicrobial TRICLOSAN SOAP TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part333E Jani-Source, LLC TRICLOSAN .003 mg/mL E 20171231 49557-875_41d0dda4-b108-4d55-b5dc-0285373f392d 49557-875 HUMAN OTC DRUG High Five Antiseptic Hand and Body Wash CHLOROXYLENOL SOAP TOPICAL 20161024 OTC MONOGRAPH NOT FINAL part333E Jani-Source, LLC CHLOROXYLENOL 3 mg/mL N 20181231 49562-515_8802dcd8-3c4f-40a5-b017-ba5e808595dc 49562-515 HUMAN OTC DRUG Thario Instant Hand Sanitizer alcohol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 Thario Building Services ALCOHOL 600 mL/1000mL E 20171231 49571-001_4ed88bb7-19d7-43bc-9cbd-4cc68a55f3a1 49571-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19590101 NDA NDA205767 Capitol Welders Supply Co., Inc. OXYGEN 99 L/100L N 20181231 49571-002_000edb6a-038f-4e4f-8ef8-b0d4551e8335 49571-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19590101 NDA NDA205766 Capitol Welders Supply Co., Inc. NITROGEN 99 L/100L N 20181231 49571-003_dca53a55-ed0e-4fde-b65c-3f40f9fcb21b 49571-003 HUMAN PRESCRIPTION DRUG MEDICAL AIR AIR GAS RESPIRATORY (INHALATION) 19590101 NDA NDA205767 Capitol Welders Supply Co., Inc. OXYGEN 21 L/100L N 20181231 49575-001_0ea98535-3607-4c2a-a7b5-f49dbed1671a 49575-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990615 NDA NDA205767 Machine & Welding Supply Company dba Arc3 Gases South OXYGEN 992 mL/L N 20181231 49575-002_0d4f43d2-c329-4f0a-bd84-6fd4013d3ad6 49575-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19990615 NDA NDA205766 Machine & Welding Supply Company dba Arc3 Gases South NITROGEN 990 mL/L N 20181231 49575-003_60b36126-686f-fbbf-e053-2a91aa0ad9a4 49575-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19900615 NDA NDA205704 Machine & Welding Supply Company dba Arc3 Gases South NITROUS OXIDE 990 mL/L N 20181231 49575-004_764aa8f5-cff5-469e-bcfc-95221582cd2b 49575-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19990615 NDA NDA205796 Machine & Welding Supply Company dba Arc3 Gases South AIR 1000 mL/L N 20181231 49580-0014_03a3da5c-622a-433b-bfad-e62004170e02 49580-0014 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20131204 OTC MONOGRAPH NOT FINAL part356 P & L Development, LLC HYDROGEN PEROXIDE 3 mL/100mL N 20181231 49580-0024_b13f4502-385c-4453-8cf3-72f23e9f5690 49580-0024 HUMAN OTC DRUG Peptic Relief Maximum Strength Maximum Strength Pepto Bismol SUSPENSION ORAL 20131211 OTC MONOGRAPH FINAL part335 P & L Development, LLC BISMUTH SUBSALICYLATE 525 mg/15mL N 20181231 49580-0110_507f83b6-a5ad-4a5f-9bc8-04943b4baf37 49580-0110 HUMAN OTC DRUG Peptic Relief Pepto Bismol SUSPENSION ORAL 20100108 OTC MONOGRAPH FINAL part335 P & L Development, LLC BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 49580-0155_ae0e45c8-c0f2-48c1-aee9-fc6c094e099a 49580-0155 HUMAN OTC DRUG Flu Relief Therapy Day Time Theraflu Daytime LIQUID ORAL 20131211 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 49580-0158_a3626465-7646-4b7a-9785-7a64ddf9c5a9 49580-0158 HUMAN OTC DRUG Childrens Mucus Relief Cough Cherry Childrens Mucinex Cough LIQUID ORAL 20131212 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 49580-0192_74a22e35-bdfe-4705-bf6d-7195d4ef6275 49580-0192 HUMAN OTC DRUG Day Time Cold Multi-Symptom Cool Blast Tylenol Multi Symptom Cool Blast Daytime LIQUID ORAL 20100101 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 10; 5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 49580-0242_806317df-61f5-4e52-9eaa-2b31758a4435 49580-0242 HUMAN OTC DRUG EZ Nite Sleep ZzzQuil LIQUID ORAL 20130101 OTC MONOGRAPH FINAL part341 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 49580-0268_033e1c5d-6251-4a9a-a58e-399d0d2bce25 49580-0268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent ReadyInCase Hydrogen Peroxide LIQUID TOPICAL 20140831 OTC MONOGRAPH NOT FINAL part356 P & L Development, LLC HYDROGEN PEROXIDE 3 mL/100mL N 20181231 49580-0269_e2d3f8fb-4ed8-4a2b-9bd0-fdc45960f29b 49580-0269 HUMAN OTC DRUG Iso Blu 50 percent Isopropyl alcohol LIQUID TOPICAL 20150531 OTC MONOGRAPH NOT FINAL part333A P & L Development, LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 49580-0271_4641b3ca-3bcc-4fbb-97b0-b370ab8dd044 49580-0271 HUMAN OTC DRUG Isopropyl alcohol 50 percent ReadyInCase Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A P & L Development, LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 49580-0272_c1270442-931e-4fa1-8972-a910cb3e1fa6 49580-0272 HUMAN OTC DRUG Isopropyl alcohol 50 percent Wintergreen ReadyInCase Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A P & L Development, LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 49580-0274_cab105a2-7d38-4642-87ee-110ca50c4d5a 49580-0274 HUMAN OTC DRUG Ethyl alcohol 70 percent ReadyInCase Ethyl alcohol LIQUID TOPICAL 20140831 OTC MONOGRAPH NOT FINAL part333A P & L Development, LLC ALCOHOL 70 mL/100mL N 20181231 49580-0275_c5607c4b-ed64-42d7-8794-172accb5aaea 49580-0275 HUMAN OTC DRUG Isopropyl alcohol 70 percent ReadyInCase Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A P & L Development, LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 49580-0276_b67e562f-caa7-483f-974e-9c1d4446d1e7 49580-0276 HUMAN OTC DRUG Isopropyl alcohol 70 percent Wintergreen ReadyInCase Isopropyl alcohol LIQUID TOPICAL 20140831 OTC MONOGRAPH NOT FINAL part333A P & L Development, LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 49580-0277_ef05f2c2-194d-4935-a004-8a1cf9a7ff38 49580-0277 HUMAN OTC DRUG Isopropyl alcohol 91 percent ReadyInCase Isopropyl alcohol LIQUID TOPICAL 20140831 OTC MONOGRAPH NOT FINAL part333A P & L Development, LLC ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 49580-0281_fbb0c485-5acd-4b18-af38-c601f8df2e7f 49580-0281 HUMAN OTC DRUG Pain Reliever Childrens Acetaminophen SUSPENSION ORAL 20160430 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 49580-0282_631f1798-0b1b-47d6-8278-2c90f28fd926 49580-0282 HUMAN OTC DRUG Pain and Fever Childrens Acetaminophen SUSPENSION ORAL 20160531 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 49580-0288_16eaad3c-3946-479f-9980-0d26e5994ef0 49580-0288 HUMAN OTC DRUG Childrens Pain Relief ReadyInCase Acetaminophen SUSPENSION ORAL 20141130 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 49580-0292_66bd130c-5ad3-49e9-82c4-99660b76f538 49580-0292 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 49580-0293_faedfe0e-3f8f-45f5-ba93-76857b3bb0a8 49580-0293 HUMAN OTC DRUG Childrens Dye Free Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 49580-0297_6b0ff35c-73aa-4ffe-b923-ce40cbceded3 49580-0297 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide SUSPENSION ORAL 20150630 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 49580-0311_6c881d7a-b832-455c-8dcb-52be0abb67dd 49580-0311 HUMAN OTC DRUG Day Time Cold and Flu Non Drowsy ReadyInCase Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 49580-0312_318c2346-0463-468f-9ca8-9a4b5002dd92 49580-0312 HUMAN OTC DRUG Cold and Allergy Childrens Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20160531 OTC MONOGRAPH FINAL part341 P & L Development, LLC BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/10mL; mg/10mL N 20181231 49580-0313_65ceecd3-9348-453c-89cb-ca69de872f98 49580-0313 HUMAN OTC DRUG Dibromm Cold and Cough Childrens Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20160531 OTC MONOGRAPH FINAL part341 P & L Development, LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 49580-0314_936934de-132d-4940-98dd-d69d589216a5 49580-0314 HUMAN OTC DRUG Sleep Aid NightTime Diphenhydramine HCl LIQUID ORAL 20160831 OTC MONOGRAPH FINAL part341 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 49580-0319_ca10c624-c68b-4173-ab98-4ad62b4f9b30 49580-0319 HUMAN OTC DRUG Pain Relief Infants Acetaminophen SUSPENSION ORAL 20160430 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 49580-0322_6fc9a3c5-6bd6-44ed-8241-c763e96e6381 49580-0322 HUMAN OTC DRUG Pain Relief Infants Acetaminophen SUSPENSION ORAL 20160430 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 49580-0324_19328862-8d52-4c6a-9d8f-33957597437c 49580-0324 HUMAN OTC DRUG Pain Relief Infants Acetaminophen SUSPENSION ORAL 20160430 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 49580-0325_4da191c2-d5d1-4283-acbe-88db28c2f541 49580-0325 HUMAN OTC DRUG Infants Gas Relief Simethicone SUSPENSION ORAL 20150630 OTC MONOGRAPH FINAL part332 P & L Development, LLC DIMETHICONE 20 mg/.3mL N 20181231 49580-0326_440488ad-ef11-48c7-80f1-9e280d856df9 49580-0326 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150131 OTC MONOGRAPH NOT FINAL part334 P & L Development, LLC MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49580-0329_0afbbe29-eed3-449d-a54d-395613074585 49580-0329 HUMAN OTC DRUG Magnesium Citrate Lemon ReadyInCase Magnesium citrate LIQUID ORAL 20140630 OTC MONOGRAPH NOT FINAL part334 P & L Development, LLC MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49580-0334_9cd9dd66-4395-4cca-b83f-beca4a067a21 49580-0334 HUMAN OTC DRUG Mineral oil Mineral oil OIL ORAL 20140831 OTC MONOGRAPH NOT FINAL part334 P & L Development, LLC MINERAL OIL 100 mg/100mL N 20181231 49580-0335_3e724666-26bc-481b-8dbe-9c9d17bbf077 49580-0335 HUMAN OTC DRUG Mucus Relief Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 49580-0342_9fb58e6f-64b9-47e0-8a5f-68ea77115a33 49580-0342 HUMAN OTC DRUG Night time cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 49580-0343_86fa90f5-ba09-4e1c-b6d3-09baa49ba7d0 49580-0343 HUMAN OTC DRUG Night Time Cold and Flu ReadyInCase Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 49580-0344_e365464c-634b-4385-bf2e-86bf75fe107d 49580-0344 HUMAN OTC DRUG Nighttime Cold and Flu ReadyInCase Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 49580-0345_a77c3fa1-ca77-4cf1-a67a-59386738ee0b 49580-0345 HUMAN OTC DRUG Nighttime Cough all night cough relief Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140731 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 49580-0346_a6677570-7f2f-4ec1-a3e5-7e87fcfde19b 49580-0346 HUMAN OTC DRUG Nighttime Cold and Flu ReadyInCase Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 49580-0371_57035962-1c46-4db9-a7e4-f6efd8065606 49580-0371 HUMAN OTC DRUG Stomach Relief Maximum Strength ReadyInCase Bismuth subsalicylate LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part335 P & L Development, LLC BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 49580-0372_4c2e59a8-0271-4123-9695-b297549d8640 49580-0372 HUMAN OTC DRUG Stomach Relief Regular Strength ReadyInCase Bismuth subsalicylate LIQUID ORAL 20140930 OTC MONOGRAPH FINAL part335 P & L Development, LLC BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 49580-0376_575216a9-9309-4143-9e71-6593e493acb3 49580-0376 HUMAN OTC DRUG Sore Throat ReadyInCase Phenol SPRAY ORAL 20141130 OTC MONOGRAPH NOT FINAL part356 P & L Development, LLC PHENOL 1.4 g/100mL N 20181231 49580-0377_de765865-a5b2-4d49-a240-49a49e3bcff8 49580-0377 HUMAN OTC DRUG Sore Throat Relief Menthol Phenol LIQUID ORAL 20160430 OTC MONOGRAPH NOT FINAL part356 P & L Development, LLC PHENOL 1.5 g/100mL N 20181231 49580-0378_ffc1de00-5349-4400-a955-63cff6e74458 49580-0378 HUMAN OTC DRUG DayTime Cold and Cough Childrens Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 49580-0379_fd33c303-4719-47b2-9025-8998ab8b7ebe 49580-0379 HUMAN OTC DRUG Childrens Triacting Nighttime Cold and Cough ReadyInCase Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 P & L Development, LLC PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE 2.5; 6.25 mg/5mL; mg/5mL N 20181231 49580-0382_5c8e6711-bb21-4e5a-a292-80b1c84439c8 49580-0382 HUMAN OTC DRUG Tussin CF Multi Symptom Cold Adult Dextromethorphan HBr, Guaifenesin, Phenylephrine LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 49580-0383_30366137-c97f-4e2c-ada5-0f6792b82858 49580-0383 HUMAN OTC DRUG Tussin Long Acting Cough READYINCASE Dextromethorphan HBr LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL N 20181231 49580-0384_5445edc2-43fb-47db-af60-eb5b37ed864f 49580-0384 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion sugar-free ReadyInCase Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/10mL; mg/10mL N 20181231 49580-0385_4beffa7b-5a16-452e-85eb-294cd98ea904 49580-0385 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion Adult Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 49580-0386_b8484833-3de0-4a8e-a94a-dcccd7c3dd13 49580-0386 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM maximum strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 49580-0389_8752bda2-c012-4177-805c-035f8781afc2 49580-0389 HUMAN OTC DRUG Tussin adult mucus and chest congestion Guaifenesin LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 P & L Development, LLC GUAIFENESIN 200 mg/10mL N 20181231 49580-0390_0652947b-c7a5-4ee9-9b94-208bad86abcf 49580-0390 HUMAN OTC DRUG Witch Hazel ReadyInCase Witch hazel LIQUID TOPICAL 20140831 OTC MONOGRAPH FINAL part347 P & L Development, LLC WITCH HAZEL 86 g/100mL N 20181231 49580-0414_f51cc997-b2bf-4c12-80bf-dbea79963315 49580-0414 HUMAN OTC DRUG Tussin DM Cough Nighttime Maximum Strength Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20160930 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL N 20181231 49580-0416_3d17d8b1-fdde-4b3c-8aac-948d8d4f934f 49580-0416 HUMAN OTC DRUG Severe cold and flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 49580-0425_13ca2bc8-8bde-4739-9e42-bad2334578cb 49580-0425 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20160531 OTC MONOGRAPH FINAL part335 P & L Development, LLC BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 49580-0454_8844257f-9265-4054-a5a0-64abee7e5c14 49580-0454 HUMAN OTC DRUG Cough Relief Grape Dextromethorphan HBr LIQUID ORAL 20160430 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 49580-0466_ae94db4c-b264-443c-8951-976e4ff73f54 49580-0466 HUMAN OTC DRUG Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 49580-0467_5d5a5895-3712-4684-a3cc-c9fc8b16dc9c 49580-0467 HUMAN OTC DRUG Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20171231 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20191231 49580-0499_a768a287-3fe7-4710-9304-5d12da1e5812 49580-0499 HUMAN OTC DRUG Night Time Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20171231 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20191231 49580-0505_ce25da5a-8267-4003-a039-f50e5877b571 49580-0505 HUMAN OTC DRUG Mucus Relief DM Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20160430 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 49580-0515_2a9bf6f0-a74a-405e-a799-b43897d58741 49580-0515 HUMAN OTC DRUG Cold Max Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI LIQUID ORAL 20161031 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 49580-0843_a67d7db1-05d0-4f83-a3ee-50b879b8caab 49580-0843 HUMAN OTC DRUG Night time cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20171231 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20191231 49580-0844_71254e35-7fb2-4c2c-82e5-04da62208590 49580-0844 HUMAN OTC DRUG Cold and Flu Relief Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20171231 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20191231 49580-0902_353f5176-5e99-4188-864b-77ddca0e5069 49580-0902 HUMAN OTC DRUG 91 Percent Isopropyl alcohol Isopropyl alcohol LIQUID TOPICAL 20120820 OTC MONOGRAPH NOT FINAL part333A P & L Development, LLC ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 49580-0905_dfcae7b3-bcea-4527-99bf-54e96f5a0488 49580-0905 HUMAN OTC DRUG Ethyl Rubbing Alcohol Ethyl Rubbing Alcohol LIQUID TOPICAL 20091003 OTC MONOGRAPH NOT FINAL part333A P & L Development, LLC ALCOHOL 70 mL/100mL N 20181231 49580-0911_40d72eab-dd79-4b85-9a90-69b2ed6160d5 49580-0911 HUMAN OTC DRUG Iso-Blu Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090402 OTC MONOGRAPH NOT FINAL part333A P & L Development, LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 49580-1403_bb61abbb-cf64-4309-91cb-5f5ac67a794a 49580-1403 HUMAN OTC DRUG Night Time Cherry Pseudo-Free NyQuil Cherry LIQUID ORAL 20051108 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 49580-1417_e6e4b5ce-2221-4656-86f2-12e6d359df98 49580-1417 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20090729 OTC MONOGRAPH FINAL part341 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 49580-1434_d69f0fa9-1750-4d1b-a8a8-db0c149cd1c0 49580-1434 HUMAN OTC DRUG Childrens Plus Multi-Symptom Cold Grape with PE Childrens Tylenol Plus Multi-Symptom Cold SUSPENSION ORAL 20090101 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 49580-2004_3db0f587-1fc1-4774-a34b-a5ea1d805bf1 49580-2004 HUMAN OTC DRUG Flu Relief Therapy Night Time Acetaminophen, DIPHENHYDRAMINE HYDROCHLORIDE, Phenylephrine Hydrochloride LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 49580-3304_06767bb2-276a-471b-8dd2-633e01e8bc59 49580-3304 HUMAN OTC DRUG Childrens Mucus Relief Cough Cherry DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20090203 OTC MONOGRAPH FINAL part341 P & L Development, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 49580-3414_f24ba0ae-cc0f-4856-ac0f-4540591463be 49580-3414 HUMAN OTC DRUG Childrens Acetaminophen Oral Grape Flavor Acetaminophen SUSPENSION ORAL 20090729 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 49580-3444_66388c84-44bc-40eb-9379-956960c32413 49580-3444 HUMAN OTC DRUG Dye-Free Childrens Acetaminophen Grape Acetaminophen SUSPENSION ORAL 20090623 20190731 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 49580-4406_639b2546-04d6-43d9-8efc-8ef597fc4865 49580-4406 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20090801 OTC MONOGRAPH NOT FINAL part356 P & L Development, LLC PHENOL 1.4 g/100mL N 20181231 49580-4506_6d3b3267-bed4-4f5f-a34c-54d222596b7f 49580-4506 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20090801 20180228 OTC MONOGRAPH NOT FINAL part356 P & L Development, LLC PHENOL 1.4 g/100mL N 20181231 49589-102_de24a080-4009-4150-abb1-06622b29db02 49589-102 HUMAN OTC DRUG SOOTHE AND CURE Hydrocotyle asiatica, Echinacea purpurea, and Sambucus Nigra Flower GEL TOPICAL 20091101 UNAPPROVED HOMEOPATHIC Izun Pharmaceuticals Corporation HYDROCOTYLE ASIATICA; ECHINACEA PURPUREA; SAMBUCUS NIGRA FLOWER .7; .35; 5.95 mg/1; mg/1; mg/1 E 20171231 49589-103_039450a4-91be-49c3-a0bb-cd1359709d77 49589-103 HUMAN OTC DRUG IZUNRINSE Hydrocotyle asiatica, Echinacea purpurea, and Sambucus Nigra Flower MOUTHWASH TOPICAL 20091101 UNAPPROVED HOMEOPATHIC Izun Pharmaceuticals Corporation HYDROCOTYLE ASIATICA; ECHINACEA PURPUREA; SAMBUCUS NIGRA FLOWER .5; .25; 4.25 g/mL; g/mL; g/mL E 20171231 49589-111_c99d713c-e21c-47bc-ae05-d4a86bb76f85 49589-111 HUMAN OTC DRUG PeriActive Sambucus nigra flower, Echinacea purpurea, and Centella Asiatica MOUTHWASH TOPICAL 20090111 UNAPPROVED HOMEOPATHIC Izun Pharmaceutical Corporation SAMBUCUS NIGRA FLOWER; ECHINACEA PURPUREA; CENTELLA ASIATICA 3; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 49589-115_7a7247e7-5513-4c7b-baf9-680eac576525 49589-115 HUMAN OTC DRUG Natural Vaginal Care Sambucus nigra flower, Echinacea purpurea, and Centella Asiatica CREAM VAGINAL 20150529 UNAPPROVED HOMEOPATHIC Izun Pharmaceuticals Corporation SAMBUCUS NIGRA FLOWER; ECHINACEA PURPUREA; CENTELLA ASIATICA 2; 3; 3 [hp_X]/2.5g; [hp_X]/2.5g; [hp_X]/2.5g E 20171231 49609-101_17e6c438-f411-44f9-b24f-86537fbbfeb8 49609-101 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F-18 INJECTION INTRAVENOUS 20111208 ANDA ANDA203591 Zevacor Pharma, Inc. FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 49609-102_10b8843a-5f98-4ebf-bb07-239eddbe5d53 49609-102 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20111208 ANDA ANDA203592 Zevacor Pharma, Inc. SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 49609-201_b299d82c-7045-4e93-a76e-be37d02e344a 49609-201 HUMAN PRESCRIPTION DRUG Ammonia N 13 Ammonia N-13 INJECTION INTRAVENOUS 20130131 ANDA ANDA204667 Zevacor Pharma, Inc. AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 49614-131_22cdf899-52f4-417f-93e4-a42881bd11cf 49614-131 HUMAN OTC DRUG The Medicine Shoppe Gentle Laxative Bisacodyl TABLET ORAL 20111014 OTC MONOGRAPH NOT FINAL part334 The Medicine Shoppe International BISACODYL 5 mg/1 N 20181231 49614-133_39b6ed99-c766-4ee9-87a6-f953c0742ddc 49614-133 HUMAN OTC DRUG Bisacodyl Laxative bisacodyl SUPPOSITORY RECTAL 20080308 OTC MONOGRAPH FINAL part334 Medicine Shoppe International Inc BISACODYL 10 mg/1 E 20171231 49614-134_ce463dcc-6a04-47be-83c4-b44221589a4f 49614-134 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 19890621 OTC MONOGRAPH NOT FINAL part334 Medicine Shoppe International MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49614-170_546ad538-0d4f-4ef8-a603-8984cbe64091 49614-170 HUMAN OTC DRUG Medicine Shoppe Loratadine Allergy Relief Loratadine TABLET ORAL 20030819 ANDA ANDA076134 The Medicine Shoppe International LORATADINE 10 mg/1 N 20181231 49614-172_47920893-349e-4826-88d7-83ebfc149794 49614-172 HUMAN OTC DRUG Medicine Shoppe Allergy Relief D24 Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 The Medicine Shoppe International LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 49614-174_14033efa-adbe-42e6-8c67-8311464554cf 49614-174 HUMAN OTC DRUG Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Medicine Shoppe International Inc LORATADINE 5 mg/5mL N 20181231 49614-191_ad868cf2-c7c5-42db-a1cc-8f68983b1779 49614-191 HUMAN OTC DRUG Soothing Bath Treatment Colloidal Oatmeal POWDER TOPICAL 20030717 OTC MONOGRAPH FINAL part347 Medicine Shoppe International Inc OATMEAL 1 g/g E 20171231 49614-221_492729bf-8e0d-4cba-b46b-01edf0d4fb47 49614-221 HUMAN OTC DRUG Alcohol Prep Pads with Pain Relief alcohol and benzocaine SWAB TOPICAL 20070628 OTC MONOGRAPH NOT FINAL part348 Medicine Shoppe International Inc BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 E 20171231 49614-404_aab81888-3f53-4f5d-814f-193835e923f4 49614-404 HUMAN OTC DRUG Medi-Cortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Medicine Shoppe International Inc HYDROCORTISONE 1 g/100g N 20181231 49614-412_0b6e3b61-2a63-4faf-ac17-b7ba9b986aea 49614-412 HUMAN OTC DRUG The Medicine Shoppe Extra Strength Pain Relieving MENTHOL GEL TOPICAL 20120126 OTC MONOGRAPH FINAL part348 Medicine Shoppe International Inc MENTHOL 3.5 mL/100mL N 20181231 49614-448_882bb8d4-69fc-4ce8-97d4-e062d6b8ad52 49614-448 HUMAN OTC DRUG The Medicine Shoppe Chest Congestion Relief Guaifenesin TABLET ORAL 20050301 OTC MONOGRAPH FINAL part341 Medicine Shoppe International Inc GUAIFENESIN 400 mg/1 N 20181231 49614-462_19a7f748-d0e0-4898-bffc-d56af1f81794 49614-462 HUMAN OTC DRUG Allergy Diphenhydramine HCl CAPSULE ORAL 19900315 20201207 OTC MONOGRAPH FINAL part341 Medicine Shoppe International Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49614-473_deaaaeb4-2919-4131-916f-1ba2018cb5b5 49614-473 HUMAN OTC DRUG Medicine Shoppe Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 The Medicine Shoppe International ACETAMINOPHEN 650 mg/1 N 20181231 49614-535_b1bc4af9-0b47-490f-8af6-98ca1d50a6e6 49614-535 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 Medicine Shoppe International Inc ASPIRIN 81 mg/1 N 20181231 49614-622_7e805afe-736c-4935-81f2-a23653a892d4 49614-622 HUMAN OTC DRUG Alcohol Pad isopropyl alcohol SWAB TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part333E Medicine Shoppe International Inc ISOPROPYL ALCOHOL .7 mL/1 E 20171231 49631-178_3c8b2479-2089-47b5-83d3-1567533f380b 49631-178 HUMAN OTC DRUG Ohtas Isan Antacid Calcium carbonate, sodium bicarbonate POWDER ORAL 20001016 OTC MONOGRAPH FINAL part331 OHTA'S ISAN CO., LTD CALCIUM CARBONATE; SODIUM BICARBONATE 1; 1 g/g; g/g N 20181231 49631-178_b0024d6d-c9d6-45fe-b9b8-cee5a03d6284 49631-178 HUMAN OTC DRUG OHTAS ISAN ANTACID calcium carbonate, sodium bicarbonate POWDER ORAL 20170701 OTC MONOGRAPH FINAL part331 OHTA'S ISAN CO.,LTD. CALCIUM CARBONATE; SODIUM BICARBONATE 1; 1 g/g; g/g N 20181231 49631-182_18ea7d4b-fc53-f158-0e6c-fe4ce795325c 49631-182 HUMAN OTC DRUG Ohtas Isan Antacid magnesium aluminosilicate, Calcium carbonate, sodium bicarbonate TABLET ORAL 20001116 OTC MONOGRAPH FINAL part331 OHTA'S ISAN CO., LTD ALMASILATE; CALCIUM CARBONATE; SODIUM BICARBONATE 125; 200; 200 mg/1; mg/1; mg/1 N 20181231 49631-212_bd89caaa-d992-517d-1477-130c534046f0 49631-212 HUMAN OTC DRUG Ohtas Isan Antacid magnesium aluminosilicate, Calcium carbonate, sodium bicarbonate TABLET ORAL 20121201 OTC MONOGRAPH FINAL part331 OHTA'S ISAN CO., LTD ALMASILATE; CALCIUM CARBONATE; SODIUM BICARBONATE 83.3; 133.3; 133.3 mg/1; mg/1; mg/1 N 20181231 49638-001_7d323d29-531f-49d0-b123-b0a9b026429a 49638-001 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET ORAL 20120515 OTC MONOGRAPH FINAL part343 America Medic ASPIRIN 81 mg/1 E 20171231 49638-002_91ec78d4-1907-43b7-a6d1-0d286b20a3c5 49638-002 HUMAN OTC DRUG TYLO Extra Strength Acetaminophen TABLET ORAL 20120515 OTC MONOGRAPH FINAL part343 America Medic ACETAMINOPHEN 500 mg/1 E 20171231 49638-481_af54c8ac-4bff-4152-8577-d69dcdbc02c4 49638-481 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20170118 OTC MONOGRAPH FINAL part343 America Medic & Science ASPIRIN 81 mg/1 N 20181231 49643-003_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-003 NON-STANDARDIZED ALLERGENIC Cattle Epithelia Cattle Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BOS TAURUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-004_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-004 NON-STANDARDIZED ALLERGENIC Cotton Linters Cotton Linters INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. COTTON FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-005_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-005 NON-STANDARDIZED ALLERGENIC Cottonseed Cottonseed INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. COTTON SEED .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 49643-006_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-006 NON-STANDARDIZED ALLERGENIC Dog Hair Dog Hair INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR .1 g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-008_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-008 NON-STANDARDIZED ALLERGENIC House Dust House Dust INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. HOUSE DUST .02 g/mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] N 20181231 49643-010_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-010 NON-STANDARDIZED ALLERGENIC Flaxseed Flaxseed INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. FLAX SEED .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 49643-011_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-011 NON-STANDARDIZED ALLERGENIC Goat Epithelia Goat Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CAPRA HIRCUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-012_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-012 NON-STANDARDIZED ALLERGENIC Guinea Pig Epithelia Guinea Pig Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CAVIA PORCELLUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-013_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-013 NON-STANDARDIZED ALLERGENIC Hamster Epithelia Hamster Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. MESOCRICETUS AURATUS SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-014_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-014 NON-STANDARDIZED ALLERGENIC Hog Epithelia Hog Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. SUS SCROFA SKIN .05 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-015_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-015 NON-STANDARDIZED ALLERGENIC Horse Epithelia Horse Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. EQUUS CABALLUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-016_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-016 NON-STANDARDIZED ALLERGENIC Jute Jute INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CORCORUS CAPSULARIS FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-017_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-017 NON-STANDARDIZED ALLERGENIC Kapok Kapok INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CEIBA PENTANDRA FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-018_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-018 NON-STANDARDIZED ALLERGENIC Karaya Gum Karaya Gum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. KARAYA GUM .01 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-019_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-019 NON-STANDARDIZED ALLERGENIC Mouse Epithelia Mouse Epithelia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. MUS MUSCULUS SKIN .1 g/mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-020_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-020 NON-STANDARDIZED ALLERGENIC Orris Root Orris Root INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT .1 g/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] N 20181231 49643-021_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-021 NON-STANDARDIZED ALLERGENIC Sisal Sisal INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AGAVE SISALANA FIBER .1 g/mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-022_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-022 NON-STANDARDIZED ALLERGENIC Tobacco Leaf Tobacco Leaf INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. TOBACCO LEAF .1 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 49643-047_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-047 NON-STANDARDIZED ALLERGENIC Cockroach, American Periplaneta americana INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PERIPLANETA AMERICANA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-048_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-048 NON-STANDARDIZED ALLERGENIC Cockroach, German Blattella germanica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BLATELLA GERMANICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-101_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-101 NON-STANDARDIZED ALLERGENIC Alternaria Alternaria alternata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-104_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-104 NON-STANDARDIZED ALLERGENIC Botrytis Botrytis cinerea INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-105_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-105 NON-STANDARDIZED ALLERGENIC Candida Candida albicans INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CANDIDA ALBICANS .05 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 49643-106_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-106 NON-STANDARDIZED ALLERGENIC Cephalosporium Cephalosporium roseum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CEPHALOSPORIUM ROSEUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-107_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-107 NON-STANDARDIZED ALLERGENIC Chaetomium Chaetomium globosum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CHAETOMIUM GLOBOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-108_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-108 NON-STANDARDIZED ALLERGENIC Cladosporium Cladosporium herbarum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CLADOSPORIUM HERBARUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-109_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-109 NON-STANDARDIZED ALLERGENIC Curvularia Curvularia lunata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. COCHLIOBOLUS LUNATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-110_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-110 NON-STANDARDIZED ALLERGENIC Epicoccum Epicoccum nigrum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 49643-111_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-111 NON-STANDARDIZED ALLERGENIC Fusarium Fusarium solani INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. HAEMATONECTRIA HAEMATOCOCCA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-112_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-112 NON-STANDARDIZED ALLERGENIC Helminthosporium sativum Helminthosporium sativum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. COCHLIOBOLUS SATIVUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-113_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-113 NON-STANDARDIZED ALLERGENIC Monilia Monilia sitophila INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CHRYSONILIA SITOPHILA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-114_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-114 NON-STANDARDIZED ALLERGENIC Mucor Mucor racemosus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. MUCOR RACEMOSUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-115_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-115 NON-STANDARDIZED ALLERGENIC Penicillium Penicillium chrysogenum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-116_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-116 NON-STANDARDIZED ALLERGENIC Phoma Phoma betae INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PLEOSPORA BETAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-117_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-117 NON-STANDARDIZED ALLERGENIC Pullularia Pullularia pullulans INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS .01 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-118_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-118 NON-STANDARDIZED ALLERGENIC Rhizopus Rhizopus oryzae INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. RHIZOPUS ARRHIZUS VAR. ARRHIZUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-120_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-120 NON-STANDARDIZED ALLERGENIC Rust, Wheat Puccinia striiformis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PUCCINIA STRIIFORMIS VAR. STRIIFORMIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-122_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-122 NON-STANDARDIZED ALLERGENIC Smut, Corn Ustilago maydis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. USTILAGO MAYDIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-123_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-123 NON-STANDARDIZED ALLERGENIC Smut, Johnson Grass Sphacelotheca cruenta INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. SPORISORIUM CRUENTUM .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-124_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-124 NON-STANDARDIZED ALLERGENIC Smut, Wheat Tilletia caries (tritici) INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. TILLETIA CARIES .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-126_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-126 NON-STANDARDIZED ALLERGENIC Stemphylium Stemphylium botryosum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PLEOSPORA TARDA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-128_f7d4e8ff-edb0-4e5c-a1b6-72635e9b2e3a 49643-128 HUMAN PRESCRIPTION DRUG Trichophyton for Intradermal Skin Testing Trichophyton mentagrophytes and Trichophyton rubrum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 20070815 BLA BLA102211 Allermed Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES; TRICHOPHYTON RUBRUM 1; 1 g/1000mL; g/1000mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-130_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-130 NON-STANDARDIZED ALLERGENIC Aspergillus fumigatus Aspergillus fumigatus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-161_6429872b-bb39-a235-e053-2991aa0a25f7 49643-161 NON-STANDARDIZED ALLERGENIC Aspergillus nidulans Aspergillus nidulans LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ASPERGILLUS NIDULANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-162_6429872b-bb39-a235-e053-2991aa0a25f7 49643-162 NON-STANDARDIZED ALLERGENIC Aspergillus niger Aspergillus niger LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-166_6429872b-bb39-a235-e053-2991aa0a25f7 49643-166 NON-STANDARDIZED ALLERGENIC Mucor plumbeus Mucor plumbeus LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. MUCOR PLUMBEUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-168_6429872b-bb39-a235-e053-2991aa0a25f7 49643-168 NON-STANDARDIZED ALLERGENIC Saccharomyces cerevisiae Saccharomyces cerevisiae LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. SACCHAROMYCES CEREVISIAE .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20191231 49643-170_6429872b-bb39-a235-e053-2991aa0a25f7 49643-170 NON-STANDARDIZED ALLERGENIC Rhizopus nigricans Rhizopus nigricans LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. RHIZOPUS STOLONIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-171_6429872b-bb39-a235-e053-2991aa0a25f7 49643-171 NON-STANDARDIZED ALLERGENIC Smut, Barley Ustilago nuda LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. USTILAGO NUDA .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-172_6429872b-bb39-a235-e053-2991aa0a25f7 49643-172 NON-STANDARDIZED ALLERGENIC Smut, Bermuda Grass Ustilago cynodontis INJECTION PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. USTILAGO CYNODONTIS .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-173_6429872b-bb39-a235-e053-2991aa0a25f7 49643-173 NON-STANDARDIZED ALLERGENIC Stemphylium solani Stemphylium solani LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. STEMPHYLIUM SOLANI .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-174_6429872b-bb39-a235-e053-2991aa0a25f7 49643-174 NON-STANDARDIZED ALLERGENIC Trichophyton mentagrophytes Trichophyton mentagrophytes LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-175_6429872b-bb39-a235-e053-2991aa0a25f7 49643-175 NON-STANDARDIZED ALLERGENIC Trichophyton rubrum Trichophyton rubrum LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. TRICHOPHYTON RUBRUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-176_6429872b-bb39-a235-e053-2991aa0a25f7 49643-176 NON-STANDARDIZED ALLERGENIC Smut, Oat Ustilago avenae LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. USTILAGO AVENAE .05 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-177_6429872b-bb39-a235-e053-2991aa0a25f7 49643-177 NON-STANDARDIZED ALLERGENIC Smut, Wheat Ustilago tritici LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. USTILAGO TRITICI .033 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-178_6429872b-bb39-a235-e053-2991aa0a25f7 49643-178 NON-STANDARDIZED ALLERGENIC Cladosporium cladosporioides Cladosporium cladosporioides LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-264_6429872b-bb39-a235-e053-2991aa0a25f7 49643-264 NON-STANDARDIZED ALLERGENIC Oak, California Mix Quercus agrifolia/Quercus kelloggii LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN; QUERCUS KELLOGGII POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-300_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-300 NON-STANDARDIZED ALLERGENIC Alfalfa Pollen Medicago sativa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. MEDICAGO SATIVA POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-301_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-301 NON-STANDARDIZED ALLERGENIC Acacia Pollen Acacia spp. INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ACACIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-302_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-302 NON-STANDARDIZED ALLERGENIC Coast Maple Pollen Acer macrophyllum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ACER MACROPHYLLUM POLLEN .05 g/mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 49643-303_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-303 NON-STANDARDIZED ALLERGENIC Box Elder Maple Pollen Acer negundo INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ACER NEGUNDO POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-304_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-304 NON-STANDARDIZED ALLERGENIC Silver Maple Pollen Acer saccharinum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ACER SACCHARINUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-305_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-305 NON-STANDARDIZED ALLERGENIC Western Waterhemp Pollen Acnida tamariscina INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-307_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-307 NON-STANDARDIZED ALLERGENIC Quackgrass Pollen Agropyron repens INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ELYMUS REPENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-308_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-308 NON-STANDARDIZED ALLERGENIC Western Wheatgrass Pollen Agropyron smithii INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PASCOPYRUM SMITHII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-309_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-309 HUMAN PRESCRIPTION DRUG Standardized Redtop Grass Agrostis alba INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102218 Allermed Laboratories, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-310_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-310 NON-STANDARDIZED ALLERGENIC Tree of Heaven Pollen Ailanthus altissima INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-311_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-311 NON-STANDARDIZED ALLERGENIC Iodine Bush Pollen Allenrolfea occidentalis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ALLENROLFEA OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-312_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-312 NON-STANDARDIZED ALLERGENIC Alder, White Pollen Alnus rhombifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-313_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-313 NON-STANDARDIZED ALLERGENIC Careless Weed Pollen Amaranthus palmerii INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-314_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-314 NON-STANDARDIZED ALLERGENIC Redroot Pigweed Pollen Amaranthus retroflexus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-315_3fcc80fc-8fff-620c-e054-00144ff8d46c 49643-315 HUMAN PRESCRIPTION DRUG Short Ragweed Ambrosia artemisiifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19820322 BLA BLA103113 Allermed Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 1 g/10mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-316_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-316 NON-STANDARDIZED ALLERGENIC Western Ragweed Pollen Ambrosia psilostachia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-317_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-317 NON-STANDARDIZED ALLERGENIC Giant Ragweed Pollen Ambrosia trifida INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-318_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-318 HUMAN PRESCRIPTION DRUG Standardized Sweet Vernal Grass Anthoxanthum odoratum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102220 Allermed Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-319_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-319 NON-STANDARDIZED ALLERGENIC Wormwood Sage Pollen Artemisia absinthium INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-320_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-320 NON-STANDARDIZED ALLERGENIC Common Sage Pollen Artemisia tridentata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-321_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-321 NON-STANDARDIZED ALLERGENIC Mugwort Sage Pollen Artemisia vulgaris INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-322_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-322 NON-STANDARDIZED ALLERGENIC Cultivated Oat Pollen Avena sativa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AVENA SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-323_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-323 NON-STANDARDIZED ALLERGENIC Bassia Pollen Bassia hyssopifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BASSIA HYSSOPIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-324_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-324 NON-STANDARDIZED ALLERGENIC Sugar Beet Pollen Beta vulgaris INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BETA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-325_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-325 NON-STANDARDIZED ALLERGENIC Gray (White) Birch Pollen Betula populifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BETULA POPULIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-326_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-326 NON-STANDARDIZED ALLERGENIC Grama grass Pollen Bouteloua spp. INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BOUTELOUA GRACILIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-327_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-327 NON-STANDARDIZED ALLERGENIC Mustard Pollen Brassica campestris INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BRASSICA RAPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-328_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-328 NON-STANDARDIZED ALLERGENIC Smooth Brome Pollen Bromus inermis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-329_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-329 NON-STANDARDIZED ALLERGENIC Cheat Grass Pollen Bromus secalinus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BROMUS SECALINUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-330_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-330 NON-STANDARDIZED ALLERGENIC Bottlebrush Pollen Callistemon citrinus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CALLISTEMON CITRINUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-332_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-332 NON-STANDARDIZED ALLERGENIC Shagbark Hickory Pollen Carya ovata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-334_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-334 NON-STANDARDIZED ALLERGENIC White Hickory Pollen Carya tomentosa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CARYA ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-335_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-335 NON-STANDARDIZED ALLERGENIC Australian Pine Pollen Casuarina equisetifoli INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CASUARINA EQUISETIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-336_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-336 NON-STANDARDIZED ALLERGENIC Hackberry Pollen Celtis occidentalis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-338_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-338 NON-STANDARDIZED ALLERGENIC Palo Verde Pollen Cercidium torreyana INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PARKINSONIA FLORIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-339_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-339 NON-STANDARDIZED ALLERGENIC Lambs Quarters Pollen Chenopodium album INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-340_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-340 NON-STANDARDIZED ALLERGENIC Hazelnut Pollen Corylus americana INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CORYLUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-341_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-341 NON-STANDARDIZED ALLERGENIC Cypress, Arizona Pollen Cupressus arizonica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-342_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-342 HUMAN PRESCRIPTION DRUG Standardized Bermuda Grass CYNODON DACTYLON INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102214 Allermed Laboratories, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-343_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-343 HUMAN PRESCRIPTION DRUG Standardized Orchard Grass Dactylis glomerata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102217 Allermed Laboratories, Inc. DACTYLIS GLOMERATA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-344_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-344 NON-STANDARDIZED ALLERGENIC Silver Ragweed Pollen Dicoria canescens INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. DICORIA CANESCENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-345_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-345 NON-STANDARDIZED ALLERGENIC Salt Grass Pollen Distichlis spicata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. DISTICHLIS SPICATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-346_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-346 NON-STANDARDIZED ALLERGENIC Russian Olive Pollen Elaeagnus angustifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ELAEAGNUS ANGUSTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-347_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-347 NON-STANDARDIZED ALLERGENIC Eucalyptus Pollen Eucalyptus globulus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-348_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-348 NON-STANDARDIZED ALLERGENIC Winterfat Pollen Eurotia lanata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. KRASCHENINNIKOVIA LANATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-349_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-349 NON-STANDARDIZED ALLERGENIC Beech Pollen Fagus grandifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-350_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-350 HUMAN PRESCRIPTION DRUG Standardized Meadow Fescue Grass Festuca elatior INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102216 Allermed Laboratories, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-351_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-351 NON-STANDARDIZED ALLERGENIC False Ragweed Pollen Ambrosia acanthicarpa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-352_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-352 NON-STANDARDIZED ALLERGENIC Canyon Ragweed Pollen Ambrosia ambrosioides INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AMBROSIA AMBROSIOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-353_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-353 NON-STANDARDIZED ALLERGENIC Sandbur Ragweed Pollen Ambrosia bipinnatifida INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AMBROSIA CHAMISSONIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-354_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-354 NON-STANDARDIZED ALLERGENIC Rabbitbush Pollen Ambrosia deltoides INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AMBROSIA DELTOIDEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-355_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-355 NON-STANDARDIZED ALLERGENIC Desert Ragweed Pollen Ambrosia dumosa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AMBROSIA DUMOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-356_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-356 NON-STANDARDIZED ALLERGENIC Slender Ragweed Pollen Ambrosia tenuifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AMBROSIA TENUIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-357_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-357 NON-STANDARDIZED ALLERGENIC White Ash Pollen Fraxinus americana INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-358_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-358 NON-STANDARDIZED ALLERGENIC Green Ash Pollen Fraxinus pennsylvanica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. FRAXINUS PENNSYLVANICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-359_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-359 NON-STANDARDIZED ALLERGENIC Arizona Ash Pollen Fraxinus velutina INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. FRAXINUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-360_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-360 NON-STANDARDIZED ALLERGENIC Sunflower Pollen Helianthus annua INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. HELIANTHUS ANNUUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-361_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-361 NON-STANDARDIZED ALLERGENIC Velvet Grass Pollen Holcus lanatus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. HOLCUS LANATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-362_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-362 NON-STANDARDIZED ALLERGENIC Burrobrush Pollen Hymenoclea salsola INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. AMBROSIA SALSOLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-363_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-363 NON-STANDARDIZED ALLERGENIC Poverty Weed Pollen Iva axillaris INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. IVA AXILLARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-364_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-364 NON-STANDARDIZED ALLERGENIC Rough Marshelder Pollen Iva ciliata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. IVA ANNUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-365_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-365 NON-STANDARDIZED ALLERGENIC Burweed Marshelder Pollen Iva xanthifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CYCLACHAENA XANTHIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-366_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-366 NON-STANDARDIZED ALLERGENIC Black Walnut Pollen Juglans nigra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-367_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-367 NON-STANDARDIZED ALLERGENIC English Walnut Pollen Juglans regia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. JUGLANS REGIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-368_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-368 NON-STANDARDIZED ALLERGENIC California Juniper Pollen Juniperus californica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. JUNIPERUS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-369_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-369 NON-STANDARDIZED ALLERGENIC Western Juniper Pollen Juniperus occidentalis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. JUNIPERUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-370_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-370 NON-STANDARDIZED ALLERGENIC Utah Juniper Pollen Juniperus osteosperma INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. JUNIPERUS OSTEOSPERMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-371_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-371 NON-STANDARDIZED ALLERGENIC Mountain Cedar Pollen Juniperus sabinoides INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-372_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-372 NON-STANDARDIZED ALLERGENIC Rocky Mtn. Juniper Pollen Juniperus scopulorum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-373_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-373 NON-STANDARDIZED ALLERGENIC Red Cedar Pollen Juniperus virginiana INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-374_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-374 NON-STANDARDIZED ALLERGENIC Burning Bush Pollen Kochia scoparia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BASSIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-375_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-375 NON-STANDARDIZED ALLERGENIC Koelers Grass Pollen Koeleria cristata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. KOELERIA MACRANTHA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-376_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-376 NON-STANDARDIZED ALLERGENIC Privet Pollen Ligustrum vulgare INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-377_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-377 NON-STANDARDIZED ALLERGENIC Sweet Gum Pollen Liquidamber styraciflua INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-379_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-379 HUMAN PRESCRIPTION DRUG Standardized Perennial Rye Grass Lolium perenne INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102219 Allermed Laboratories, Inc. LOLIUM PERENNE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-380_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-380 NON-STANDARDIZED ALLERGENIC Melaleuca Pollen Melaleuca leucadendron INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-382_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-382 NON-STANDARDIZED ALLERGENIC White Mulbery Pollen Morus alba INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. MORUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-383_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-383 NON-STANDARDIZED ALLERGENIC European Olive Pollen Olea europea INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-384_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-384 NON-STANDARDIZED ALLERGENIC Bahia Grass Pollen Paspalum notatum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-385_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-385 NON-STANDARDIZED ALLERGENIC Canary Grass Pollen Phalaris arundinaceae INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PHALARIS ARUNDINACEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-386_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-386 HUMAN PRESCRIPTION DRUG Standardized Timothy Grass Phleum pratense INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102221 Allermed Laboratories, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-387_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-387 NON-STANDARDIZED ALLERGENIC Date Palm Pollen Phoenix dactylifera INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PHOENIX DACTYLIFERA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-388_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-388 NON-STANDARDIZED ALLERGENIC Eastern White Pine Pollen Pinus strobus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PINUS STROBUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-389_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-389 NON-STANDARDIZED ALLERGENIC English Plantain Pollen Plantago lanceolata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-391_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-391 NON-STANDARDIZED ALLERGENIC Eastern Sycamore Pollen Platanus occidentalis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-392_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-392 NON-STANDARDIZED ALLERGENIC Western Sycamore Pollen Platanus racemosa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PLATANUS RACEMOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-393_e24f1cbe-e247-4bcd-aa7c-b0d297e815ac 49643-393 HUMAN PRESCRIPTION DRUG Standardized Kentucky Blue (June) Grass Poa pratensis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19961202 BLA BLA102215 Allermed Laboratories, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-394_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-394 NON-STANDARDIZED ALLERGENIC White Poplar Pollen Populus alba INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. POPULUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-395_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-395 NON-STANDARDIZED ALLERGENIC Eastern Cottonwood Pollen Populus deltoides INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-396_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-396 NON-STANDARDIZED ALLERGENIC Fremont Cottonwood Pollen Populus fremontii INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. POPULUS FREMONTII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-397_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-397 NON-STANDARDIZED ALLERGENIC Lombard Poplar Pollen Populus nigra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. POPULUS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-398_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-398 NON-STANDARDIZED ALLERGENIC Aspen Pollen Populus tremuloides INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. POPULUS TREMULOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-399_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-399 NON-STANDARDIZED ALLERGENIC Black Cottonwood Pollen Populus trichocarpa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. POPULUS TRICHOCARPA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-400_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-400 NON-STANDARDIZED ALLERGENIC Mesquite Pollen Prosopis juliflora INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-401_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-401 NON-STANDARDIZED ALLERGENIC Coast Live Oak Pollen Quercus agrifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. QUERCUS AGRIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-402_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-402 NON-STANDARDIZED ALLERGENIC White Oak Pollen Quercus alba INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. QUERCUS ALBA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-403_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-403 NON-STANDARDIZED ALLERGENIC California Scrub Oak Pollen Quercus dumosa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. QUERCUS DUMOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-404_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-404 NON-STANDARDIZED ALLERGENIC Gambels Oak Pollen Quercus gambelii INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. QUERCUS GAMBELII POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-405_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-405 NON-STANDARDIZED ALLERGENIC Sheep Sorrel Pollen Rumex acetosella INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 49643-406_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-406 NON-STANDARDIZED ALLERGENIC Dock, Yellow Pollen Rumex crispus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. RUMEX CRISPUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-407_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-407 NON-STANDARDIZED ALLERGENIC Pussy Willow Pollen Salix discolor INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. SALIX DISCOLOR POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-408_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-408 NON-STANDARDIZED ALLERGENIC Arroyo Willow Pollen Salix lasiolepsis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. SALIX LASIOLEPIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-409_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-409 NON-STANDARDIZED ALLERGENIC Black Willow Pollen Salix nigra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-410_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-410 NON-STANDARDIZED ALLERGENIC Russian Thistle Pollen Salsola kali INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-411_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-411 NON-STANDARDIZED ALLERGENIC Greasewood Pollen Sarcobatus vermiculatus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-412_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-412 NON-STANDARDIZED ALLERGENIC Pepper Tree Pollen Schinus molle INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-413_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-413 NON-STANDARDIZED ALLERGENIC Johnson Grass Pollen Sorghum halepense INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-414_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-414 NON-STANDARDIZED ALLERGENIC Alkali Blite Pollen Suaeda spp. INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. SUAEDA NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-415_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-415 NON-STANDARDIZED ALLERGENIC Salt Cedar Pollen Tamarix gallica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. TAMARIX GALLICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-416_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-416 NON-STANDARDIZED ALLERGENIC Dandelion Pollen Taraxacum officinale INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. TARAXACUM OFFICINALE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-417_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-417 NON-STANDARDIZED ALLERGENIC American Elm Pollen Ulmus americana INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-419_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-419 NON-STANDARDIZED ALLERGENIC Chinese Elm Pollen Ulmus pumila INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ULMUS PUMILA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-420_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-420 NON-STANDARDIZED ALLERGENIC Cocklebur Pollen Xanthium commune INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-422_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-422 NON-STANDARDIZED ALLERGENIC Corn Pollen Pollen Zea mays INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-423_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-423 NON-STANDARDIZED ALLERGENIC Nettle Pollen Urtica dioica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. URTICA DIOICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-434_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-434 NON-STANDARDIZED ALLERGENIC Red Maple Pollen Acer rubrum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ACER RUBRUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-435_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-435 NON-STANDARDIZED ALLERGENIC Red Alder Pollen Alnus rubra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ALNUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-436_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-436 NON-STANDARDIZED ALLERGENIC Tag Alder Pollen Alnus rugosa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-437_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-437 NON-STANDARDIZED ALLERGENIC Coast Sage Pollen Artemisia californica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ARTEMISIA CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-438_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-438 NON-STANDARDIZED ALLERGENIC Wing Scale Pollen Atriplex canescens INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ATRIPLEX CANESCENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-439_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-439 NON-STANDARDIZED ALLERGENIC Shad Scale Pollen Atriplex confertifolia INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ATRIPLEX CONFERTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-440_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-440 NON-STANDARDIZED ALLERGENIC Lens Scale Pollen Atriplex lentiformis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ATRIPLEX LENTIFORMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-441_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-441 NON-STANDARDIZED ALLERGENIC Spring Birch Pollen Betula fontinalis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BETULA OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-442_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-442 NON-STANDARDIZED ALLERGENIC Cherry Birch Pollen Betula lenta INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BETULA LENTA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-443_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-443 NON-STANDARDIZED ALLERGENIC River/Red Birch Pollen Betula nigra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. BETULA NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-444_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-444 NON-STANDARDIZED ALLERGENIC Pecan Pollen Carya illinoinensis INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-446_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-446 NON-STANDARDIZED ALLERGENIC Calif. Black Walnut Pollen Juglans californica INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. JUGLANS CALIFORNICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-447_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-447 NON-STANDARDIZED ALLERGENIC Red Mulberry Pollen Morus rubra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. MORUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-448_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-448 NON-STANDARDIZED ALLERGENIC Shortleaf Pine Pollen Pinus echinata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PINUS ECHINATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-449_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-449 NON-STANDARDIZED ALLERGENIC Yellow Pine Pollen Pinus ponderosa INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PINUS PONDEROSA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-450_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-450 NON-STANDARDIZED ALLERGENIC Red Oak Pollen Quercus rubra INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-451_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-451 NON-STANDARDIZED ALLERGENIC Black Oak Pollen Quercus velutina INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. QUERCUS VELUTINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-452_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-452 NON-STANDARDIZED ALLERGENIC Hard Maple Pollen Acer saccharum INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-460_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-460 NON-STANDARDIZED ALLERGENIC Linden Pollen Tilia cordata INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. TILIA CORDATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-501_6429872b-bb39-a235-e053-2991aa0a25f7 49643-501 NON-STANDARDIZED ALLERGENIC Alder Mix Alnus rhombifolia/Alnus rubra/Alnus rugosa LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ALNUS RHOMBIFOLIA POLLEN; ALNUS RUBRA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-520_6429872b-bb39-a235-e053-2991aa0a25f7 49643-520 NON-STANDARDIZED ALLERGENIC Maple, California Mix Acer macrophyllum/Acer negundo LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. ACER NEGUNDO POLLEN; ACER MACROPHYLLUM POLLEN .025; .025 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20191231 49643-524_6429872b-bb39-a235-e053-2991aa0a25f7 49643-524 NON-STANDARDIZED ALLERGENIC Pine Mix Pinus echinata/Pinus ponderosa/Pinus strobus LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. PINUS ECHINATA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-544_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-544 NON-STANDARDIZED ALLERGENIC Walnut Mix Walnut Mix INJECTION PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. JUGLANS NIGRA POLLEN; JUGLANS REGIA POLLEN; JUGLANS CALIFORNICA POLLEN .0167; .0167; .0167 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Increased Histamine Release [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-702_5664e19e-6019-4b8b-b2d0-c349910bcf07 49643-702 HUMAN PRESCRIPTION DRUG House Dust Mite, Dermatophagoides farinae House Dust Mite, Dermatophagoides farinae INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19861224 BLA BLA102212 Allermed Laboratories, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-704_5664e19e-6019-4b8b-b2d0-c349910bcf07 49643-704 HUMAN PRESCRIPTION DRUG House Dust Mite, Dermatophagoides pteronyssinus House Dust Mite, Dermatophagoides pteronyssinus INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19861224 BLA BLA102213 Allermed Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 49643-705_4794134f-8c59-4a48-bcb3-032bd384dc4e 49643-705 HUMAN PRESCRIPTION DRUG Cat Hair Cat Hair INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19920815 BLA BLA103473 Allermed Laboratories, Inc. FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] N 20181231 49643-802_6429872b-bb39-a235-e053-2991aa0a25f7 49643-802 NON-STANDARDIZED ALLERGENIC Trichophyton Mix Trichophyton mentagrophytes/Trichophyton rubrum LIQUID PERCUTANEOUS; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. TRICHOPHYTON RUBRUM; TRICHOPHYTON MENTAGROPHYTES .005; .0005 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 49643-818_4f1be4f6-9f9e-5c19-e054-00144ff8d46c 49643-818 NON-STANDARDIZED ALLERGENIC Glycerol-Saline Control Glycerol-Saline Diluent INJECTION CUTANEOUS; INTRADERMAL; SUBCUTANEOUS 19740312 BLA BLA102211 Allermed Laboratories, Inc. GLYCERIN .53 g/mL Non-Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Glycerol [Chemical/Ingredient] N 20181231 49644-001_61434e9d-ab07-d4ba-e053-2991aa0a59a1 49644-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19700101 NDA NDA206023 Terry Supply Company Inc OXYGEN 997 mL/L N 20181231 49647-0001_0b8672eb-e9e3-45c9-bbbe-4a3ce11e3361 49647-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20090629 UNAPPROVED MEDICAL GAS Wenzl Drug, Inc OXYGEN 99 L/100L E 20171231 49653-001_02e4d867-7f71-44de-9d32-2f80f51852f5 49653-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800321 NDA NDA205767 Superior Welding Supply Co OXYGEN 990 mL/L N 20191231 49653-002_90ad727c-671b-4bfa-af07-12137c29c636 49653-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19800321 UNAPPROVED MEDICAL GAS Superior Welding Supply Co NITROGEN 990 mL/L E 20171231 49658-1001_061ba527-b2fb-472d-b5b3-1b7d598b1aff 49658-1001 HUMAN OTC DRUG HairQ PYRITHIONE ZINC SHAMPOO TOPICAL 20120523 UNAPPROVED DRUG OTHER Cresson PYRITHIONE ZINC .1 mL/100mL E 20171231 49658-2001_c0cdfc33-66c5-4f25-b2be-73b28f989726 49658-2001 HUMAN OTC DRUG HairQ-Plus BIOTIN SHAMPOO TOPICAL 20120523 UNAPPROVED DRUG OTHER Cresson BIOTIN .06 mL/100mL E 20171231 49658-3001_9a896b34-1e0f-459d-a29c-dc8c1792f268 49658-3001 HUMAN OTC DRUG HairQ PYRITHIONE ZINC SOLUTION TOPICAL 20120523 UNAPPROVED DRUG OTHER Cresson PYRITHIONE ZINC .1 mL/100mL E 20171231 49658-4001_1c58c007-5cfa-45e4-921d-78c68ceecb28 49658-4001 HUMAN OTC DRUG HairQ-Plus BIOTIN SOLUTION TOPICAL 20120525 UNAPPROVED DRUG OTHER Cresson BIOTIN .06 mL/100mL E 20171231 49663-001_08143c14-809a-4203-965e-7fd3bdec0807 49663-001 HUMAN PRESCRIPTION DRUG PROCYSBI Delayed-release cysteamine bitartrate CAPSULE, DELAYED RELEASE PELLETS ORAL 20130430 20190228 NDA NDA203389 Raptor Therapeutics Inc. CYSTEAMINE BITARTRATE 25 mg/1 Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] N 20181231 49663-002_08143c14-809a-4203-965e-7fd3bdec0807 49663-002 HUMAN PRESCRIPTION DRUG PROCYSBI Delayed-release cysteamine bitartrate CAPSULE, DELAYED RELEASE PELLETS ORAL 20130430 20190228 NDA NDA203389 Raptor Therapeutics Inc. CYSTEAMINE BITARTRATE 75 mg/1 Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] N 20181231 49668-001_3aba460a-1912-4794-a317-f477af962b40 49668-001 HUMAN OTC DRUG Carboxymethylcellulose sodium Carboxymethylcellulose sodium SOLUTION OPHTHALMIC 20091001 OTC MONOGRAPH FINAL part349 PROMED EXPORTS PRIVATE LIMITED CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL E 20171231 49671-001_4830f52a-e9c7-6a41-e054-00144ff88e88 49671-001 HUMAN OTC DRUG Wellness Products J-FLEX CAPSAICIN CREAM TOPICAL 20120412 OTC MONOGRAPH NOT FINAL part348 Wellness Products CAPSAICIN .07 g/100g N 20181231 49671-002_4830f52a-e9d7-6a41-e054-00144ff88e88 49671-002 HUMAN OTC DRUG Wellness Products VictoRx CAPSAICIN CREAM TOPICAL 20120607 OTC MONOGRAPH NOT FINAL part348 Wellness Products CAPSAICIN .07 g/100g N 20181231 49672-100_f2f97861-043b-456a-89d1-505acc6246d1 49672-100 HUMAN OTC DRUG TECHNIblock ULTRA SUNSCREEN AVOBENZONE,OCTINOXATE,OXYBENZONE,PADIMATE LOTION TOPICAL 20100405 OTC MONOGRAPH FINAL part352 The Myles Group LLC AVOBENZONE; OCTINOXATE; OXYBENZONE; PADIMATE A .6; 6.3; 3.4; 5.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 49673-424_e6e278f4-f056-4aed-addd-76a970e281bb 49673-424 HUMAN PRESCRIPTION DRUG Indocyanine green Indocyanine green INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120701 ANDA ANDA040811 Novadaq Technologies Inc. INDOCYANINE GREEN 25 mg/1 E 20171231 49678-1005_86f17b54-e097-4373-9bc6-af13b92db10b 49678-1005 HUMAN OTC DRUG Dynamic Defence Concentrate Anti-Ageing Day SPF 15 OCTYL METHOXYCINNAMATE , OCTYL SALICYLATE, OXYBENZONE, AND AVOBENZONE CREAM TOPICAL 20100504 OTC MONOGRAPH FINAL part352 SARAH CHAPMAN LTD OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 50; 50; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 49681-001_e5d5c331-5e03-9d75-5fcd-e43cb8d62c7e 49681-001 HUMAN OTC DRUG Vitale Sensitive Scalp Daily Scalp Healer Pyrithione Zinc CREAM TOPICAL 20091101 OTC MONOGRAPH FINAL part358 JF Labs, Inc. PYRITHIONE ZINC 250 mg/100g E 20171231 49681-002_4666b310-b806-f603-4c2d-2e94761169bb 49681-002 HUMAN OTC DRUG Vitale Sensitive Scalp 12 in 1 Instant Relief Anti Dandruff Spray Salicylic Acid SPRAY TOPICAL 20091101 OTC MONOGRAPH FINAL part358 JF Labs, Inc. SALICYLIC ACID 15 mg/mL E 20171231 49681-010_39cc039b-b58c-6925-31d9-9564f377201d 49681-010 HUMAN OTC DRUG Lusti Therapeutic Ice Analgesic Rub menthol, camphor GEL TOPICAL 20100324 OTC MONOGRAPH NOT FINAL part348 JF Labs, Inc. MENTHOL; CAMPHOR (SYNTHETIC) .015; .031 g/g; g/g E 20171231 49681-012_33f0793c-a486-39ca-dbda-e05f299cd840 49681-012 HUMAN OTC DRUG Lusti Profesional Vaporizing Rub Camphor,Eucalyptus Oil, Menthol OINTMENT TOPICAL 20100804 OTC MONOGRAPH FINAL part341 JF Labs, Inc. CAMPHOR, (SYNTHETIC); EUCALYPTUS OIL; MENTHOL .048; .012; .026 g/g; g/g; g/g E 20171231 49685-928_5bf1a6d7-539b-4cbb-944f-3a1f39128d4f 49685-928 HUMAN PRESCRIPTION DRUG Qutenza capsaicin KIT 20100301 NDA NDA022395 NeurogesX, Inc. N 20181231 49687-0010_3c681072-55aa-100a-e054-00144ff8d46c 49687-0010 HUMAN OTC DRUG Eye Wash WATER SOLUTION OPHTHALMIC 20160809 OTC MONOGRAPH FINAL part349 CMC Group Inc. WATER 991 mg/mL N 20181231 49687-0011_39b88326-bf60-545e-e054-00144ff8d46c 49687-0011 HUMAN OTC DRUG Antiseptic Towelettes BENZALKONIUM CHLORIDE CLOTH TOPICAL 20160806 OTC MONOGRAPH NOT FINAL part333A CMC Group Inc. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 49687-0012_39b88326-bf6c-545e-e054-00144ff8d46c 49687-0012 HUMAN OTC DRUG Alcohol Cleansing ISOPROPYL ALCOHOL CLOTH TOPICAL 20160806 OTC MONOGRAPH NOT FINAL part333A CMC Group Inc. ISOPROPYL ALCOHOL 70 g/100g N 20181231 49687-0013_3a3680e8-028f-6a58-e054-00144ff8d46c 49687-0013 HUMAN OTC DRUG Antibiotic Application BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE OINTMENT TOPICAL 20160806 OTC MONOGRAPH FINAL part333B CMC Group, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 49687-0014_3a6cd104-c821-015e-e054-00144ff88e88 49687-0014 HUMAN OTC DRUG Burn Treatment BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20160806 OTC MONOGRAPH NOT FINAL part333A CMC Group Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; .5 g/100g; g/100g N 20181231 49687-0015_39b89055-8645-67af-e054-00144ff8d46c 49687-0015 HUMAN OTC DRUG Hand Sanitizer ALCOHOL GEL TOPICAL 20160808 OTC MONOGRAPH NOT FINAL part333E CMC Group Inc. ALCOHOL .62 g/g N 20181231 49687-0016_6107df1e-f7bc-3040-e053-2991aa0a7451 49687-0016 HUMAN OTC DRUG Refill 2 BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20160810 OTC MONOGRAPH NOT FINAL part333 CMC Group, Inc. N 20181231 49687-0017_6107ed2c-0691-754b-e053-2a91aa0a2eca 49687-0017 HUMAN OTC DRUG Refill 3 BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part333A CMC Group Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; .5 g/100g; g/100g N 20181231 49687-0018_6107aff5-a597-1b21-e053-2a91aa0af862 49687-0018 HUMAN OTC DRUG Refill 4 ISOPROPYL ALCOHOL CLOTH TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part333A CMC Group Inc. ISOPROPYL ALCOHOL 70 g/100g N 20181231 49687-0019_6107aff5-a57a-1b21-e053-2a91aa0af862 49687-0019 HUMAN OTC DRUG Refill 6 ALCOHOL, WATER KIT 20160810 OTC MONOGRAPH NOT FINAL part333 CMC Group, Inc. N 20181231 49687-0020_6107aff5-a4f4-1b21-e053-2a91aa0af862 49687-0020 HUMAN OTC DRUG Standard ANSI First Aid WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE KIT 20160810 OTC MONOGRAPH NOT FINAL part333 CMC Group, Inc. N 20181231 49687-0021_610787e1-5f70-e2e3-e053-2a91aa0ae6a2 49687-0021 HUMAN OTC DRUG Large ANSI First Aid Kit WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE KIT 20160809 OTC MONOGRAPH NOT FINAL part333 CMC Group, Inc. N 20181231 49693-1001_280436c4-0260-4bc2-8c3d-d80d1f29b54f 49693-1001 HUMAN OTC DRUG Aspergillus Aspergillus niger var. niger LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo ASPERGILLUS NIGER VAR. NIGER 4 [hp_X]/10mL E 20171231 49693-1101_66546d5c-a8b0-4894-817e-d82f399a97ac 49693-1101 HUMAN OTC DRUG Candida Candida parapsilosis LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo CANDIDA PARAPSILOSIS 4 [hp_X]/10mL E 20171231 49693-1301_87f66e2e-ffef-400b-bf7a-cfff9d99e14a 49693-1301 HUMAN OTC DRUG Mucor Mucor racemosus LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo MUCOR RACEMOSUS 4 [hp_X]/10mL E 20171231 49693-1306_bb64565a-3f29-4b46-be43-84373e03c67f 49693-1306 HUMAN OTC DRUG Mucor Mucor racemosus LIQUID OPHTHALMIC 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo MUCOR RACEMOSUS 5 [hp_X]/5mL E 20171231 49693-1401_7537f2a7-b0ea-4b8e-8c24-690aaf1c34e5 49693-1401 HUMAN OTC DRUG Mucor/Aspergillus Mucor racemosus and Aspergillus niger var. niger LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo MUCOR RACEMOSUS; ASPERGILLUS NIGER VAR. NIGER 4; 4 [hp_X]/10mL; [hp_X]/10mL E 20171231 49693-1501_55fe1ebe-5cee-4447-a6e0-faee948b59a9 49693-1501 HUMAN OTC DRUG Notatum Penicillium Chrysogenum Var. Chrysogenum LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [hp_X]/10mL E 20171231 49693-1601_96db674c-cd96-4555-912f-ec770413d1bd 49693-1601 HUMAN OTC DRUG Notatum-Quentans Penicillium chrysogenum var. chrysogenum and Penicillium glabrum LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM 4; 4 [hp_X]/10mL; [hp_X]/10mL E 20171231 49693-1604_fecf48bb-b6bc-4185-88cf-95f1f6631be6 49693-1604 HUMAN OTC DRUG Notatum-Quentans Penicillium chrysogenum var. chrysogenum and Penicillium glabrum SUSPENSION/ DROPS NASAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM 4; 4 [hp_X]/10mL; [hp_X]/10mL E 20171231 49693-1701_514a89fa-ddc3-4493-bc9d-c80e233f87d5 49693-1701 HUMAN OTC DRUG Quentans Penicillium glabrum LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo PENICILLIUM GLABRUM 4 [hp_X]/10mL E 20171231 49693-1801_09feba2f-b6b5-458d-af19-e7ab0c84e93e 49693-1801 HUMAN OTC DRUG Roqueforti Penicillium roqueforti LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo PENICILLIUM ROQUEFORTI 4 [hp_X]/10mL E 20171231 49693-2001_323bf388-43f1-42de-adc8-265ca164aa6f 49693-2001 HUMAN OTC DRUG Cereus Bacillus cereus LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo BACILLUS CEREUS 6 [hp_X]/5mL E 20171231 49693-2101_7bb653a1-456e-4674-b00b-50aecd53aeb8 49693-2101 HUMAN OTC DRUG Firmus Bacillus firmus LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo BACILLUS FIRMUS 6 [hp_X]/5mL E 20171231 49693-2201_e0374546-af46-43b5-babd-db2c9849786e 49693-2201 HUMAN OTC DRUG Mycobactin S Mycobacterium phlei LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo MYCOBACTERIUM PHLEI 6 [hp_X]/5mL E 20171231 49693-2301_1b295707-cae6-4a8d-9d90-da81a54e3ab7 49693-2301 HUMAN OTC DRUG Subtilis Bacillus subtilis LIQUID ORAL 20091215 UNAPPROVED HOMEOPATHIC USPharmaCo BACILLUS SUBTILIS 6 [hp_X]/5mL E 20171231 49696-622_5aeebd30-19fc-4633-b4ae-939d2a7fcfa9 49696-622 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19550101 UNAPPROVED MEDICAL GAS Oxygen Service Company, Inc OXYGEN 99 L/100L E 20171231 49696-632_5aeebd30-19fc-4633-b4ae-939d2a7fcfa9 49696-632 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19550101 UNAPPROVED MEDICAL GAS Oxygen Service Company, Inc OXYGEN 99 L/100L E 20171231 49701-2000_fc31e3f2-edb3-44f9-b55d-d54785703f9a 49701-2000 HUMAN OTC DRUG Antibacterial Hand Sanitizer Spray ALCOHOL SPRAY TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 The Webb Company ALCOHOL 62 mL/100mL E 20171231 49701-3000_7664a7ae-1c09-498e-aaaa-4c00b2b96ead 49701-3000 HUMAN OTC DRUG Antibacterial Hand Sanitizer Gel ALCOHOL GEL TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 The Webb Company ALCOHOL 62 mL/100mL E 20171231 49701-4000_926f0d23-a4f5-4d45-a364-e58bf5257b02 49701-4000 HUMAN OTC DRUG Citrus Scent Antibacterial Hand Wipe BENZALKONIUM CHLORIDE SWAB TOPICAL 20091124 OTC MONOGRAPH NOT FINAL part333 The Webb Company BENZALKONIUM CHLORIDE .1 1/1 E 20171231 49701-9000_65f7c57b-3787-4c7a-9399-a1f858045109 49701-9000 HUMAN OTC DRUG Webb Candy Peppermint Candy Cane Lip Balm LIPSTICK TOPICAL 20090911 OTC MONOGRAPH FINAL part352 Webb Candy OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 3; 2 g/100g; g/100g; g/100g E 20171231 49701-9001_4ec7c880-0e07-411c-9add-312499ec11ed 49701-9001 HUMAN OTC DRUG Cherry Candy Cane Lip Balm Octinoxate, Oxybenzone, Octisalate LIPSTICK TOPICAL 20090911 OTC MONOGRAPH FINAL part352 Webb Candy OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 3; 2 g/100g; g/100g; g/100g E 20171231 49702-202_459f25dc-f8d4-4801-b882-5d86409280b2 49702-202 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 20101019 NDA NDA020857 ViiV Healthcare Company LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-203_6f889614-bc31-4c40-97b5-963be9c28c07 49702-203 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20101004 NDA NDA020564 ViiV Healthcare Company LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-204_6f889614-bc31-4c40-97b5-963be9c28c07 49702-204 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20101004 NDA NDA020564 ViiV Healthcare Company LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-205_6f889614-bc31-4c40-97b5-963be9c28c07 49702-205 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine SOLUTION ORAL 20101004 NDA NDA020596 ViiV Healthcare Company LAMIVUDINE 10 mg/mL Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-206_0221430c-c188-48d1-8c49-9256f7b6a896 49702-206 HUMAN PRESCRIPTION DRUG EPZICOM abacavir sulfate and lamivudine TABLET, FILM COATED ORAL 20101012 NDA NDA021652 ViiV Healthcare Company ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-207_4564569b-1107-413d-aaef-12ff2e0a8675 49702-207 HUMAN PRESCRIPTION DRUG LEXIVA fosamprenavir calcium TABLET, FILM COATED ORAL 20101004 NDA NDA021548 ViiV Healthcare Company FOSAMPRENAVIR CALCIUM 700 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],P-Glycoprotein Inducers [MoA] N 20181231 49702-208_4564569b-1107-413d-aaef-12ff2e0a8675 49702-208 HUMAN PRESCRIPTION DRUG LEXIVA fosamprenavir calcium SUSPENSION ORAL 20101004 NDA NDA022116 ViiV Healthcare Company FOSAMPRENAVIR CALCIUM 50 mg/mL HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],P-Glycoprotein Inducers [MoA] N 20181231 49702-209_bd0a3b2a-cb86-4a9f-badc-4f9f8037dc18 49702-209 HUMAN PRESCRIPTION DRUG RESCRIPTOR delavirdine mesylate TABLET ORAL 20101013 NDA NDA020705 ViiV Healthcare Company DELAVIRDINE MESYLATE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-211_454868b1-a0fe-43eb-8af7-c244b127bc32 49702-211 HUMAN PRESCRIPTION DRUG RETROVIR zidovudine CAPSULE ORAL 20101028 NDA NDA019655 ViiV Healthcare Company ZIDOVUDINE 100 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-212_454868b1-a0fe-43eb-8af7-c244b127bc32 49702-212 HUMAN PRESCRIPTION DRUG RETROVIR zidovudine SYRUP ORAL 20101028 NDA NDA019910 ViiV Healthcare Company ZIDOVUDINE 10 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-213_454868b1-a0fe-43eb-8af7-c244b127bc32 49702-213 HUMAN PRESCRIPTION DRUG RETROVIR zidovudine INJECTION, SOLUTION INTRAVENOUS 20101104 NDA NDA019951 ViiV Healthcare Company ZIDOVUDINE 10 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-217_3cc3a365-e877-4ebf-84d3-1a08d507f8e3 49702-217 HUMAN PRESCRIPTION DRUG TRIZIVIR abacavir sulfate, lamivudine, and zidovudine TABLET, FILM COATED ORAL 20101102 NDA NDA021205 ViiV Healthcare Company ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE 300; 150; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-221_1d009fec-e3a2-416c-8a89-37d7d54739f3 49702-221 HUMAN PRESCRIPTION DRUG ZIAGEN abacavir sulfate TABLET, FILM COATED ORAL 19981229 NDA NDA020977 ViiV Healthcare Company ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-222_1d009fec-e3a2-416c-8a89-37d7d54739f3 49702-222 HUMAN PRESCRIPTION DRUG ZIAGEN abacavir sulfate SOLUTION ORAL 19990128 NDA NDA020978 ViiV Healthcare Company ABACAVIR SULFATE 20 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-223_af4a9734-c224-4d54-8247-38e621e64ea3 49702-223 HUMAN PRESCRIPTION DRUG SELZENTRY maraviroc TABLET, FILM COATED ORAL 20110516 NDA NDA022128 ViiV Healthcare Company MARAVIROC 150 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] N 20181231 49702-224_af4a9734-c224-4d54-8247-38e621e64ea3 49702-224 HUMAN PRESCRIPTION DRUG SELZENTRY maraviroc TABLET, FILM COATED ORAL 20110516 NDA NDA022128 ViiV Healthcare Company MARAVIROC 300 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] N 20181231 49702-225_bd0a3b2a-cb86-4a9f-badc-4f9f8037dc18 49702-225 HUMAN PRESCRIPTION DRUG RESCRIPTOR delavirdine mesylate TABLET ORAL 20120411 NDA NDA020705 ViiV Healthcare Company DELAVIRDINE MESYLATE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-226_36990c23-0f08-4194-9ca9-0fe2ce77bf2e 49702-226 HUMAN PRESCRIPTION DRUG Tivicay dolutegravir sodium TABLET, FILM COATED ORAL 20160609 NDA NDA204790 ViiV Healthcare Company DOLUTEGRAVIR SODIUM 10 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 49702-227_36990c23-0f08-4194-9ca9-0fe2ce77bf2e 49702-227 HUMAN PRESCRIPTION DRUG Tivicay dolutegravir sodium TABLET, FILM COATED ORAL 20160609 NDA NDA204790 ViiV Healthcare Company DOLUTEGRAVIR SODIUM 25 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 49702-228_36990c23-0f08-4194-9ca9-0fe2ce77bf2e 49702-228 HUMAN PRESCRIPTION DRUG Tivicay dolutegravir sodium TABLET, FILM COATED ORAL 20130813 NDA NDA204790 ViiV Healthcare Company DOLUTEGRAVIR SODIUM 50 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 49702-231_a975461d-3a35-4c71-aaa2-d0f17d58b1fc 49702-231 HUMAN PRESCRIPTION DRUG Triumeq abacavir sulfate, dolutegravir sodium, lamivudine TABLET, FILM COATED ORAL 20140822 NDA NDA205551 ViiV Healthcare Company ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE 600; 50; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 49702-233_af4a9734-c224-4d54-8247-38e621e64ea3 49702-233 HUMAN PRESCRIPTION DRUG SELZENTRY maraviroc TABLET, FILM COATED ORAL 20161104 NDA NDA022128 ViiV Healthcare Company MARAVIROC 25 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] N 20181231 49702-235_af4a9734-c224-4d54-8247-38e621e64ea3 49702-235 HUMAN PRESCRIPTION DRUG SELZENTRY maraviroc TABLET, FILM COATED ORAL 20161104 NDA NDA022128 ViiV Healthcare Company MARAVIROC 75 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] N 20181231 49702-237_af4a9734-c224-4d54-8247-38e621e64ea3 49702-237 HUMAN PRESCRIPTION DRUG SELZENTRY maraviroc SOLUTION ORAL 20161104 NDA NDA208984 ViiV Healthcare Company MARAVIROC 20 mg/mL CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] N 20181231 49702-242_6199b67d-3b29-4348-81f7-e7da7927c507 49702-242 HUMAN PRESCRIPTION DRUG Juluca dolutegravir sodium and rilpivirine hydrochloride TABLET, FILM COATED ORAL 20171121 NDA NDA210192 ViiV Healthcare Company DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE 50; 25 mg/1; mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [Chemical/Ingredient] N 20181231 49708-101_7a94885b-62b6-4db9-8d01-f594be8dba13 49708-101 HUMAN PRESCRIPTION DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20090814 NDA NDA022418 Caraco Pharma, Inc. FENOFIBRIC ACID 35 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] E 20171231 49708-102_7a94885b-62b6-4db9-8d01-f594be8dba13 49708-102 HUMAN PRESCRIPTION DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20090814 NDA NDA022418 Caraco Pharma, Inc. FENOFIBRIC ACID 105 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] E 20171231 49708-145_b3ce197f-a541-44ca-a12d-e0c4460412e8 49708-145 HUMAN PRESCRIPTION DRUG Bactrim sulfamethoxazole and Trimethoprim TABLET ORAL 20041101 NDA NDA017377 Sun Pharmaceutical Industries, Inc SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 49708-146_b3ce197f-a541-44ca-a12d-e0c4460412e8 49708-146 HUMAN PRESCRIPTION DRUG Bactrim DS sulfamethoxazole and Trimethoprim TABLET ORAL 20041101 NDA NDA017377 Sun Pharmaceutical Industries, Inc SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 49708-153_23b2114f-fa6c-4567-85bd-69892bc74de9 49708-153 HUMAN PRESCRIPTION DRUG Qualaquin Quinine Sulfate CAPSULE ORAL 20050812 NDA NDA021799 Sun Pharmaceutical Industries, Inc. QUININE SULFATE 324 mg/1 Antimalarial [EPC] N 20181231 49708-419_7f5a021d-7474-4639-92d8-bbb761737c87 49708-419 HUMAN PRESCRIPTION DRUG Synalgos Aspirin, Caffeine, and Dihydrocodeine Bitartrate Capsules CAPSULE ORAL 20081230 NDA NDA011483 Caraco Pharma Inc. ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE 356.4; 30; 16 mg/1; mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 49708-521_3f2752c1-89c7-483d-a974-e47b75ffa259 49708-521 HUMAN PRESCRIPTION DRUG Flumadine flumadine TABLET ORAL 20090922 NDA NDA019649 Caraco Pharma, Inc. RIMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 49708-644_bfd3f76e-094c-4148-a74b-f10efed03685 49708-644 HUMAN PRESCRIPTION DRUG ELIXOPHYLLIN THEOPHYLLINE ANHYDROUS LIQUID ORAL 20091001 ANDA ANDA085186 Caraco Pharma, Inc. THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 49708-754_8bb03980-2e6c-47c2-bf36-b817f609dc66 49708-754 HUMAN PRESCRIPTION DRUG BromSite 0.075% bromfenac SOLUTION/ DROPS OPHTHALMIC 20160501 NDA NDA206911 Sun Pharmaceutical Industries, Inc. BROMFENAC SODIUM .76 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49710-0001_93eef23c-1f71-4f81-a7ba-53d7ec72db1e 49710-0001 HUMAN OTC DRUG Optimal Diet Drops Fucus Vesiculosus, Cyanocobalamin, Glandula Suprarenalis Suis, Hepar Suis, L Carnitine, L Ornithine LIQUID ORAL 20130311 UNAPPROVED HOMEOPATHIC Optimal Labs LLC FUCUS VESICULOSUS; CYANOCOBALAMIN; SUS SCROFA ADRENAL GLAND; PORK LIVER; LEVOCARNITINE; ORNITHINE; ANTIMONY TRISULFIDE; SUS SCROFA THYROID; SODIUM SULFATE; PANCRELIPASE; SUS SCROFA HYPOTHALAMUS 2; 6; 6; 6; 6; 6; 8; 8; 10; 12; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49715-001_f1b5402d-6f4c-4d4b-b629-6bcc05a29034 49715-001 HUMAN OTC DRUG J and R Perfect Essence Beblesh Balm (40mL) TITANIUM DIOXIDE OCTINOXATE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; OCTINOXATE 3.6; 1.6 mL/40mL; mL/40mL E 20171231 49715-002_5373e6a1-1175-4dd8-ac66-e400f206f998 49715-002 HUMAN OTC DRUG SKIN 79 Super Plus Beblesh Balm SPF25 PA (40g) TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE 1.92; .78 g/40g; g/40g E 20171231 49715-003_8f1fdbb9-349f-4e80-b69d-e5ca411bdc0b 49715-003 HUMAN OTC DRUG SKIN79 Super Plus Beblesh Balm Triple Functions SPF25 PA (5g) ZINC OXIDE, OCTISALATE, OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20091001 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ZINC OXIDE; OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE .1; .1; .15; .24 g/5g; g/5g; g/5g; g/5g E 20171231 49715-004_9e62e349-eb9a-466b-9f27-f97e8f955515 49715-004 HUMAN OTC DRUG SKIN 79 The Prestige Beblesh Balm (5g) ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ZINC OXIDE; TITANIUM DIOXIDE .19; .312 g/5g; g/5g E 20171231 49715-005_3ef970da-b81a-4e01-8022-f940d4e08f45 49715-005 HUMAN OTC DRUG SKIN 79 Super Plus Beblesh Balm Triple Functions SPF25 PA (40g) ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ZINC OXIDE; OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE .78; .8; 1.2; 1.92 g/40g; g/40g; g/40g; g/40g E 20171231 49715-006_b057c6df-a75b-49cd-bd5b-2b6191095d33 49715-006 HUMAN OTC DRUG SKIN 79 The Prestige Beblesh Balm (40g) ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD ZINC OXIDE; TITANIUM DIOXIDE 1.54; 2.5 g/40g; g/40g E 20171231 49715-007_961857f9-b7fd-43f6-aa44-7f120e2c41ed 49715-007 HUMAN OTC DRUG Super Plus Beblesh Balm Triple Functions SPF50 Plus PA 3Plus (40g) TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, AMILOXATE, ARBUTIN, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; AMILOXATE; ARBUTIN; ADENOSINE 5.52; 1.569; 2.8; .4; .8; .016 g/40g; g/40g; g/40g; g/40g; g/40g; g/40g E 20171231 49715-008_01c4d4e4-62a5-4901-8746-511eb2c8f02b 49715-008 HUMAN OTC DRUG The Prestige BB SPF25 PA 2Plus TITANIUM DIOXIDE, ZINC OXIDE, ARBUTIN, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE; ARBUTIN; ADENOSINE 2.5; 1.54; .8; .016 g/40g; g/40g; g/40g; g/40g E 20171231 49715-009_e6cd817f-eb06-4d40-a2a6-9af3a9c028a4 49715-009 HUMAN OTC DRUG Sun Protect Beblesh Pact SPF30 PA 2Plus TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE 1.125; .75 g/15g; g/15g E 20171231 49715-010_235c341a-03b1-4c37-bbff-46744c0c7142 49715-010 HUMAN OTC DRUG The Oriental Gold BB SPF25 PA 2Plus TITANIUM DIOXIDE, ZINC OXIDE, ARBUTIN, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE; ARBUTIN; ADENOSINE 2.5; 1.54; .8; .016 g/40g; g/40g; g/40g; g/40g E 20171231 49715-011_48208893-0350-453a-aa5a-de1fa6673ec8 49715-011 HUMAN OTC DRUG Absolute Total BB SPF37 PA 3Plus TITANIUM DIOXIDE, ZINC OXIDE, ARBUTIN, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE; ARBUTIN; ADENOSINE 3.6; 2.52; .8; .016 g/40g; g/40g; g/40g; g/40g E 20171231 49715-012_3763e28f-eda9-4ffa-88b2-3f0b3c74ac21 49715-012 HUMAN OTC DRUG Super Plus Beblesh Balm Triple Functions SPF25 PA 2Plus TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE 1.875; 1.25 g/25g; g/25g E 20171231 49715-013_9177a2ba-206e-4c0a-b5b0-3a164508f7e3 49715-013 HUMAN OTC DRUG Homme Aqua Sun Block SPF50 Plus PA 2Plus OCTINOXATE, OCTISALATE, ENSULIZOLE, BEMOTRIZINOL, AVOBENZONE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD OCTINOXATE; OCTISALATE; ENSULIZOLE; BEMOTRIZINOL; AVOBENZONE 3.26; 2.175; 1.74; 1.305; 1.305 g/43.5g; g/43.5g; g/43.5g; g/43.5g; g/43.5g E 20171231 49715-014_1fe70565-1417-45de-aa7e-691f916d1b12 49715-014 HUMAN OTC DRUG SuperPlus Beblesh Balm Triple Functions SPF25 PA 2Plus TITANIUM DIOXIDE, CTINOXATE, OCTISALATE, ARBUTIN, ZINC OXIDE, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE; ARBUTIN; ADENOSINE; OCTINOXATE; OCTISALATE 1.92; .768; .8; .016; 1.2; .8 g/40g; g/40g; g/40g; g/40g; g/40g; g/40g E 20171231 49715-015_730b1887-7bb8-46bd-a496-9b494c34ad3a 49715-015 HUMAN OTC DRUG SuperPlus Beblesh Balm Gold SPF25 PA 2Plus TITANIUM DIOXIDE, ZINC OXIDE, ARBUTIN, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE; ARBUTIN; ADENOSINE 1.56; .96; .5; .01 g/25g; g/25g; g/25g; g/25g E 20171231 49715-016_7c53be37-7056-41b6-b53f-93812fb73e68 49715-016 HUMAN OTC DRUG SuperPlus Beblesh Balm Gold SPF25 PA 2Plus TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ARBUTIN, ZINC OXIDE, ADENOSINE CREAM TOPICAL 20111201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE; ARBUTIN; ADENOSINE; OCTINOXATE; OCTISALATE 1.92; .78; .8; .016; 1.2; .8 g/40g; g/40g; g/40g; g/40g; g/40g; g/40g E 20171231 49715-017_8148764f-8aa6-4d78-87de-4ae5635e6355 49715-017 HUMAN OTC DRUG SuperPlus Beblesh Balm SPF25 PA 2Plus TITANIUM DIOXIDE, ZINC OXIDE, ARBUTIN, ADENOSINE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE; ARBUTIN; ADENOSINE 1.56; .96; .5; .01 g/25g; g/25g; g/25g; g/25g E 20171231 49715-018_17643708-053c-4aed-a3da-0abbf1d6e06d 49715-018 HUMAN OTC DRUG SuperPlus Beblesh Balm SPF25 PA 2Plus TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ARBUTIN, ZINC OXIDE, ADENOSINE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD TITANIUM DIOXIDE; ZINC OXIDE; ARBUTIN; ADENOSINE; OCTINOXATE; OCTISALATE 1.92; .78; .8; .016; 1.2; .8 g/40g; g/40g; g/40g; g/40g; g/40g; g/40g E 20171231 49715-019_6b9a720d-96f7-4f70-8938-aea18203e254 49715-019 HUMAN OTC DRUG SKIN79 SNAIL NUTRITION BBCREAM Snail Secretion Filtrate Titanium Dioxide Zinc Oxide Arbutin Adenosine CREAM TOPICAL 20130301 OTC MONOGRAPH FINAL part352 WIZCOZ CORPORATION LTD SNAIL, UNSPECIFIED; TITANIUM DIOXIDE; ZINC OXIDE; ARBUTIN; ADENOSINE 18.05; 3.6; 2.52; .8; .016 g/40g; g/40g; g/40g; g/40g; g/40g E 20171231 49721-0001_861c4866-fd4c-43b9-bf10-8574f70e1ec9 49721-0001 HUMAN OTC DRUG Liquid Detox Drops Citrus Limonum, Taraxacum Officinale, Uva Ursi, Berberis Vulgaris, Capsicum Annuum, Galium Aparine, Lobelia Inflata LIQUID ORAL 20130403 UNAPPROVED HOMEOPATHIC Weight Loss Products LLC LEMON JUICE; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CAPSICUM; GALIUM APARINE; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; SCHISANDRA CHINENSIS FRUIT; TYLOPHORA INDICA LEAF; PORK BRAIN; PORK HEART; SUS SCROFA ADRENAL GLAND; PORK LIVER; CALCIUM SULFIDE; PORK INTESTINE; PORK KIDNEY; LACTIC ACID; SUS SCROFA LUNG; SUS SCROFA LYMPH; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SUS SCROFA SPLEEN; SUS SCROFA THYROID 1; 2; 2; 3; 3; 3; 3; 3; 3; 3; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49721-0003_eded6ea9-4348-4c50-b219-2017393f20c7 49721-0003 HUMAN OTC DRUG RK Detox Drops not applicable LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC Weight Loss Products, LLC LEMON JUICE; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CAPSICUM; GALIUM APARINE; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; SCHISANDRA CHINENSIS FRUIT; TYLOPHORA INDICA WHOLE; PORK BRAIN; SUS SCROFA ADRENAL GLAND; PORK HEART; PORK LIVER; CALCIUM SULFIDE; PORK INTESTINE; PORK KIDNEY; LACTIC ACID, DL-; SUS SCROFA LUNG; SUS SCROFA LYMPH; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SUS SCROFA SPLEEN; SUS SCROFA THYROID 1; 2; 2; 3; 3; 3; 3; 3; 3; 3; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 49725-926_f910e9d7-b443-4ad1-a88f-93bdfc26858c 49725-926 HUMAN OTC DRUG Antimicrobial Hand Sanitizing Lotion Mango Scented Ethyl Alcohol LOTION TOPICAL 20090928 OTC MONOGRAPH FINAL part333 HandsFree ALCOHOL 62 mL/100mL N 20181231 49726-002_4da7f83c-4826-4a4c-b95b-7e4f89db5b87 49726-002 HUMAN OTC DRUG Activive Fatigue Symptom Relief Alfalfa, Ambra Grisea, Anacardium Orientale, Argentum Nitricum, Aurum Metalicum, Avena Sativa, Caladium Seguinum, Calcarea Carbonica, Cocculus Indicus, Gelsemium Sempervirens, Ignatia Amara, Kali Phosphoricum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Selenium Metallicum, Sepia, Silicea, Sulphur LIQUID ORAL 20100107 UNAPPROVED HOMEOPATHIC Hello Life, Inc. ALFALFA; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-003_7e548810-4ced-4a4d-aeb0-4063cbe17aa5 49726-003 HUMAN OTC DRUG Respitrol Respiratory Symptom Relief Ammonium Carbonicum, Antimonim Arsenicosum, Antimonium Tartaricum, Arsenicum Album, Bromium, Carbo Vegetabilis, Chlorinum, Kali Carbonicum, Lobelia Inflata, Stannum Metallicum, Sulphuricum Acidum LIQUID ORAL 20100107 UNAPPROVED HOMEOPATHIC Hello Life, Inc. AMMONIUM CARBONATE; ANTIMONY ARSENATE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BROMINE; ACTIVATED CHARCOAL; CHLORINE; POTASSIUM CARBONATE; LOBELIA INFLATA; TIN; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-004_375dcad3-5e6d-4382-b217-126c11499f76 49726-004 HUMAN OTC DRUG Rhumatol Arthitis Symptom and Muscle Pain Relief ACTAEA SPICATA, AESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALCAREA CARBONICA, CALCAREA FLUORICA, CAUSTICUM, CIMICIFUGA RACEMOSA, FORMICUM ACIDUM, HYPERICUM PERFORATUM, LEDUM PAULSTRE, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHODODENDRON CHRYSANTHUM, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SALICYLICUM ACIDUM, SEPIA, ZINCUM METALLICUM LIQUID ORAL 20100107 UNAPPROVED HOMEOPATHIC Hello Life, Inc. ACTAEA SPICATA ROOT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; HORSE CHESTNUT; PHOSPHORUS; LITHIUM CARBONATE; SEPIA OFFICINALIS JUICE; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-005_3fa24bee-0a03-41bb-96ec-c99aea665d11 49726-005 HUMAN OTC DRUG Candidol Candida Overgrowth Sympton Relief Abies Nigra, Antimonium Crudum, Asafoetida, Baptisia Tinctoria, Borax, Candida Albicans, Lachesis Mutus, Phosphoricum Acidum, Phytolacca Decandra, Pulsatilla, Sticta Pulmonaria, Sulphur, Thuja Occidentalis LIQUID ORAL; TOPICAL 20100107 UNAPPROVED HOMEOPATHIC Hello Life, Inc. PICEA MARIANA RESIN; ANTIMONY TRISULFIDE; ASAFETIDA; BAPTISIA TINCTORIA; SODIUM BORATE; CANDIDA ALBICANS; LACHESIS MUTA VENOM; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; LOBARIA PULMONARIA; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-006_45e2f4fe-f123-4752-9295-f43d302f537f 49726-006 HUMAN OTC DRUG Claritose ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARUNDO MURITANICA, ARUM TRIPHYLIUM, EUPHRASIA OFFICINALIS, NAPHTHALINUM, NATRUM MURIATICUM, SABADILLA, WYETHIA HELENIODES LIQUID ORAL 20100107 UNAPPROVED HOMEOPATHIC Hello Life, Inc. ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ARUNDO PLINIANA ROOT; ARISAEMA TRIPHYLLUM ROOT; EUPHRASIA STRICTA; NAPHTHALENE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; WYETHIA HELENIOIDES ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-009_e50137f1-df98-4148-9577-d7c4de0d3bc3 49726-009 HUMAN OTC DRUG Viratrol Herpes Symptom Relief Apis Mellifica, Arsenicum Album, Borax, Capsicum Annuum, Graphites, Mentha piperita, Mezereum, Natrum muriaticum, Nux vomica, Petroleum, Ranunculus bulbosus LIQUID ORAL; TOPICAL 20100107 UNAPPROVED HOMEOPATHIC Hello Life, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; SODIUM BORATE; CAPSICUM; GRAPHITE; PEPPERMINT; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PARAFFIN; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-012_2db73bfe-7c3e-4786-b136-39563a3ed234 49726-012 HUMAN OTC DRUG Painazol Pain Relief ACTAEA SPICATA, AESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA ALBA, CALCAREA CARBONICA, CALCAREA FLUORICA, CAUSTICUM, CIMICIFUGA RACEMOSA, FORMICUM ACIDUM, HYPERICUM PERFORATUM, LEDUM PAULSTRE, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHODODENDRON CHRYSANTHUM, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SALICYLICUM ACIDUM, SEPIA, SULPHUR, ZINCUM METALLICUM LIQUID ORAL; TOPICAL 20100520 UNAPPROVED HOMEOPATHIC Hello Life, Inc. ACTAEA SPICATA ROOT; AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; SULFUR; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-015_7408f007-0487-46bf-bff6-d5c1df887ee2 49726-015 HUMAN OTC DRUG Neuroveen Neuropathy Symptom Relief Acontium Napellus, Agaricus Muscarius, Baryta Muriatica, Calendula Officinalis, Carbo Vegetabilis, Carduus Marianus, Chamomilla, Dulcamara, Glonoinum, Hamamelis Virginiana, Lycopersicum Esculentum, Magnesia Phosphorica, Phosphorus, Plumbum Metallicum, Rhus Toxicondendron, Secale Cornutum LIQUID ORAL; TOPICAL 20100914 UNAPPROVED HOMEOPATHIC Hello Life, Inc. ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA; BARIUM CHLORIDE DIHYDRATE; CALENDULA OFFICINALIS FLOWERING TOP; ACTIVATED CHARCOAL; SILYBUM MARIANUM SEED; MATRICARIA RECUTITA; SOLANUM DULCAMARA TOP; NITROGLYCERIN; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOMATO; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; LEAD; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-016_88c6eae4-b11c-4bcc-aad7-0001c93135bf 49726-016 HUMAN OTC DRUG Premensa PMS Symptom Relief Apis Mellifica, Chamomilla, Cimicifuga Racemosa, Cyclamen Europaeum, Helonias Dioca, Ignatia Amara, Lac Caninum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Platinum Metallicum, Sepia LIQUID ORAL 20110221 UNAPPROVED HOMEOPATHIC Hello Life, Inc. APIS MELLIFERA; CHAMOMILE; BLACK COHOSH; CYCLAMEN PURPURASCENS TUBER; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; CANIS LUPUS FAMILIARIS MILK; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PLATINUM; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-017_ae3afe80-47e9-4a37-8e87-c4ad3ff440df 49726-017 HUMAN OTC DRUG Honey Dont Cough Aconitum napellus, Bromium, Coccus Cacti, Corallium Rubrum, Cuprum Metallicum, Drosera Rotundifolia, Hepar Sulphuris Calcareum, Iodium, Mephitis Mephitica, Spongia Tosta SYRUP ORAL 20110314 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a Hello Life Inc. ACONITUM NAPELLUS; MEPHITIS MEPHITIS ANAL GLAND FLUID; BROMINE; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; COPPER; DROSERA ROTUNDIFOLIA; CALCIUM SULFIDE; IODINE; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL N 20181231 49726-018_7b8a5f40-6de9-4802-9c52-c8888f9e6d1e 49726-018 HUMAN OTC DRUG Anxietin Anxiety Symptom Relief Aconitum Napellus, Alfalfa, Argentum Nitricum, Aresenicum Album, Aurum Metallicum, Baryta Carbonica, Calcarea Phosphorica, Chamomilla, Kali Phosphoricum, Kali Arsenicosum, Natrum Phosphoricum, Staphysagria, Phosphorus, Stramonium, Ignatia Amara, Muriaticum Acidum, Gelsemium Sempervirens, Passiflora Incarnata, Glononium, Humulus Lupulus, Avena Sativa LIQUID ORAL 20110401 UNAPPROVED HOMEOPATHIC Hello Life, Inc. ACONITUM NAPELLUS; ALFALFA; SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; CHAMOMILE; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; STRYCHNOS IGNATII SEED; POTASSIUM ARSENITE ANHYDROUS; POTASSIUM PHOSPHATE, DIBASIC; HOPS; HYDROCHLORIC ACID; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PASSIFLORA INCARNATA FLOWER; PHOSPHORUS; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; ARSENIC TRIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-019_3f26ddf3-0431-42ea-83ab-b8ec04b5efa2 49726-019 HUMAN OTC DRUG Stressivin Stress Relief Aconitum napellus, Hypericum perforatum, Apis mellifica, Arsenicum album, Arnica montana, Calendula officinalis, Ferrum phosphoricum, Histaminum hydrochloricum, Ignatia amara, Belladonna, Bellis perennis, Chamomilla, Bryonia, Passiflora incarnata, Sulphur, Symphytum officinale, Veratrum album, Cistus canadensis, Clematis erecta, Phosphorus, Impatiens glandulifera, flos, Prunus cerasifera, flos, Ornithogalum umbellatum, flos, Rhus toxicodendron LIQUID ORAL 20111107 UNAPPROVED HOMEOPATHIC Hello Life, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; FERRUM PHOSPHORICUM; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWER; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF; SULFUR; COMFREY ROOT; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-022_2285e5e0-f87f-4c4c-8bb4-588449b25b12 49726-022 HUMAN OTC DRUG Restulex Restless Leg Symptom Relief Arsenicum album, Bufo rana, Causticum, Chamomilla, Crotalus horridus, Digitalis purpurea, Lachesis mutus, Lilium tigrinum, Pulsatilla, Rhus toxicodendron, Sulphur, Tarentula hispana, Viscum album, Zincum metallicum LIQUID ORAL; TOPICAL 20111109 UNAPPROVED HOMEOPATHIC Hello Life, Inc. ARSENIC TRIOXIDE; BUFO BUFO CUTANEOUS GLAND; CAUSTICUM; MATRICARIA RECUTITA; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM FLOWERING TOP; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SULFUR; LYCOSA TARANTULA; VISCUM ALBUM FRUITING TOP; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-023_96748160-3467-4b61-8022-46c3713810b0 49726-023 HUMAN OTC DRUG Goutinex Gout Symptom Relief ACTAEA SPICATA, AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, PHYTOLACCA DECANDRA, RHODODENDRON CHRYSANTHUM, SALICYLICUM ACIDUM, URTICA URENS LIQUID ORAL 20111109 UNAPPROVED HOMEOPATHIC Hello Life, Inc. ACTAEA SPICATA ROOT; AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; SALICYLIC ACID; URTICA URENS; LEDUM PALUSTRE TWIG; FRAXINUS EXCELSIOR LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-025_e8f585f6-f072-439b-89f7-91ee34e7080e 49726-025 HUMAN OTC DRUG Thyroveev Hyperthyroid Symptom Relief Antimonium crudum, Antimonium iodatum, Aqua Marina, Argentum iodatum, Badiaga, Bromium, Calcarea Carbonica, Calcarea Iodata, Cobaltum nitricum, Ferrum iodatum, Fucus, Gelsemium, Gentianella amarella flos, Hydrastis, Ignatia, Iodium, Kali iodatum, Lapis, Natrum bromatum, Natrum muriaticum, Parathormonum, Phosphoricum acidum, Rosmarinus, Sulphur iodatum, Thyroidinum LIQUID ORAL 20120815 UNAPPROVED HOMEOPATHIC Hello Life, Inc. ANTIMONY TRISULFIDE; ANTIMONY TRIIODIDE; SODIUM CHLORIDE; SILVER IODIDE; SPONGILLA LACUSTRIS; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM IODIDE; COBALTOUS NITRATE HEXAHYDRATE; FERROUS IODIDE; FUCUS VESICULOSUS; GELSEMIUM SEMPERVIRENS ROOT; GENTIANELLA AMARELLA FLOWER; GOLDENSEAL; STRYCHNOS IGNATII SEED; IODINE; POTASSIUM IODIDE; CALCIUM HEXAFLUOROSILICATE; SODIUM BROMIDE; THYROID, UNSPECIFIED; PARATHYROID HORMONE; PHOSPHORIC ACID; ROSMARINUS OFFICINALIS FLOWERING TOP; SULFUR IODIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-026_256d79b4-9dca-47b4-a4ba-0034a8df4076 49726-026 HUMAN OTC DRUG Insomulex Insomnia Symptom Relief Aesculus hipp, flos, Ambra, Arsenicum alb, Avena, Baryta carb, Camphora, Cinchona, Cocculus, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Ignatia, Kali brom, Kali phos, Mag carb, Muriaticum ac, Nat phos, Passiflora, Scutellaria, Sulphur, Valeriana, Zinc met LIQUID ORAL 20120815 UNAPPROVED HOMEOPATHIC Hello Life, Inc. AESCULUS HIPPOCASTANUM FLOWER; AMBERGRIS; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM CARBONATE; HYDROCHLORIC ACID; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PASSIFLORA INCARNATA FLOWERING TOP; ARSENIC TRIOXIDE; SCUTELLARIA LATERIFLORA; SULFUR; VALERIAN; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-027_a5fedd96-83bb-483e-a294-add4b2004fc4 49726-027 HUMAN OTC DRUG Diet Defense ABIES CANADENSIS, ANACARDIUM ORIENTALE, ARGENTUM METALLICUM, ADRENOCORTICOTROPHIN, HYPOTHALAMUS, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM PHOSPHORICUM, PHOSPHORUS, PITUITARUM POSTERIUM, SABADILLA, STAPHYSAGRIA, SULPHUR, THYROIDINUM, VERATRUM ALBUM LIQUID ORAL 20111024 UNAPPROVED HOMEOPATHIC Hello Life, Inc. TSUGA CANADENSIS BARK; SEMECARPUS ANACARDIUM JUICE; SILVER; CORTICOTROPIN; BOS TAURUS HYPOTHALAMUS; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PHOSPHORUS; SUS SCROFA PITUITARY GLAND; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THYROID, UNSPECIFIED; VERATRUM ALBUM ROOT 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1 [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL; [hp_Q]/59mL N 20181231 49726-028_38100e98-7cac-4c24-98fd-2b327a42ca34 49726-028 HUMAN OTC DRUG Synaptol Aconitum ferox, adrenallnum, aesculus hippocastanum, apis mellifica, argentum nitricum, avena sativa, baptisia tinctoria, cochlearia armoracia, phosphorus, scleranthus annuus, scutellaria lateriflora, sumbul, viola odorata LIQUID ORAL 20120831 UNAPPROVED HOMEOPATHIC Hello Life, Inc. ACONITUM FEROX ROOT; EPINEPHRINE; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; SILVER NITRATE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; HORSERADISH; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; FERULA SUMBUL ROOT; VIOLA ODORATA 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-029_543cee0b-4e47-4191-b7bf-6bb9d553b5d0 49726-029 HUMAN OTC DRUG Licenex Agaricus musc, Bovista, Muriaticum Ac, Pix liquida, Staphysag, Sulphur, Anacardium or, Apis mel, Causticum, Graphites, Oleander, Quassia, Rhus tox SHAMPOO TOPICAL 20130501 UNAPPROVED HOMEOPATHIC Hello Life, Inc. AMANITA MUSCARIA FRUITING BODY; LYCOPERDON UTRIFORME FRUITING BODY; HYDROCHLORIC ACID; QUASSIA AMARA WOOD; PINE TAR; DELPHINIUM STAPHISAGRIA SEED; SULFUR; SEMECARPUS ANACARDIUM JUICE; APIS MELLIFERA; CAUSTICUM; GRAPHITE; NERIUM OLEANDER LEAF; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL N 20181231 49726-030_2f8701e2-11f7-4cf2-a0ef-182f48d03aaf 49726-030 HUMAN OTC DRUG Genitrex Agaricus musc, Bovista, Muriaticum Ac, Pix liquida, Staphysag, Sulphur, Anacardium or, Apis mel, Causticum, Graphites, Oleander, Rhus tox SHAMPOO TOPICAL 20130204 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife LLC AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; LYCOPERDON UTRIFORME FRUITING BODY; HYDROCHLORIC ACID; PINE TAR; DELPHINIUM STAPHISAGRIA SEED; SULFUR; SEMECARPUS ANACARDIUM JUICE; APIS MELLIFERA; CAUSTICUM; GRAPHITE; NERIUM OLEANDER LEAF; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 6; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL N 20181231 49726-031_09eb856e-9730-43a2-a3b8-3017836c6906 49726-031 HUMAN OTC DRUG MoodBrite Seasonal Depression Symptom Relief anacardium orientale, larix decidua, flos, aurum metallicum, avena sativa, calcarea carbonica, cinchona officinalis, hypericum perforatum, kali bromatum, natrum sulphuricum, tabacum, ignatia amara, pulsatilla, sepia, sinapis arvensis, flos, cimicifuga racemosa, natrum carbonicum, phosphoricum acidum, phosphorus, carpinus betulus, flos LIQUID ORAL 20130308 UNAPPROVED HOMEOPATHIC Hello Life, Inc. SEMECARPUS ANACARDIUM JUICE; LARIX DECIDUA FLOWERING TOP; GOLD; AVENA SATIVA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CINCHONA OFFICINALIS BARK; HYPERICUM PERFORATUM; POTASSIUM BROMIDE; SODIUM SULFATE; TOBACCO LEAF; STRYCHNOS IGNATII SEED; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; SODIUM CARBONATE; PHOSPHORIC ACID; PHOSPHORUS; CARPINUS BETULUS FLOWERING TOP; BLACK COHOSH 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-033_065f538f-92c6-4f30-b1cb-1597e8a4eaa0 49726-033 HUMAN OTC DRUG Painazol Shingles Symptom Relief Cream Cedron, Mezereum, Phytolacca, Sempervivum, Croton, Mentha pip, Rhus tox, Dulcamara, Ranunc bulb, Grindelia, Salicylicum ac CREAM TOPICAL 20130805 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. SIMABA CEDRON SEED; DAPHNE MEZEREUM BARK; PHYTOLACCA AMERICANA ROOT; SEMPERVIVUM TECTORUM LEAF; CROTON TIGLIUM SEED; MENTHA PIPERITA; TOXICODENDRON PUBESCENS LEAF; SOLANUM DULCAMARA TOP; RANUNCULUS BULBOSUS; GRINDELIA HIRSUTULA FLOWERING TOP; SALICYLIC ACID 3; 1; 1; 2; 3; 1; 3; 2; 3; 1; 3 [hp_C]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g; [hp_X]/128g N 20181231 49726-034_675e1a10-f0d2-4085-a5bd-9af940d7b888 49726-034 HUMAN OTC DRUG Compulsin ARSENICUM ALBUM, ARSENICUM IODATUM, CALCAREA CARBONICA, COFFEA CRUDA, IODIUM, ULMUS PROCERA, FLOS, MANCINELLA, PHYSOSTIGMA VENENOSUM, SILICEA LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC Hello Life, Inc. ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; IODINE; ULMUS PROCERA FLOWERING TWIG; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 49726-035_4778568f-221f-443d-871a-1741141bc075 49726-035 HUMAN OTC DRUG Painazol Pain Relief Aconitum nap, Actaea, Aesculus hipp, Cimicifuga, Gnaphalium poly, Lilium, Lycopersicum, Oxalicum ac, Arnica, Bellis, Bryonia, Salicylicum ac, Colocynthis, Iris vers, Mag phos, Ruta, Stellaria med, Hypericum GEL TOPICAL 20131024 UNAPPROVED HOMEOPATHIC Ionx Holdings d/b/a HelloLife Inc. ACONITUM NAPELLUS; ACTAEA SPICATA ROOT; HORSE CHESTNUT; BLACK COHOSH; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LILIUM LANCIFOLIUM WHOLE FLOWERING; SOLANUM LYCOPERSICUM; OXALIC ACID DIHYDRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; SALICYLIC ACID; CITRULLUS COLOCYNTHIS FRUIT PULP; IRIS VERSICOLOR ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP; STELLARIA MEDIA; HYPERICUM PERFORATUM 5; 5; 5; 5; 5; 5; 5; 6; 5; 5; 5; 5; 5; 5; 8; 5; 5; 5 [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g E 20171231 49726-037_b3420046-8164-4f3f-a5d4-9697d107c000 49726-037 HUMAN OTC DRUG Vertaway Amyl Nitrosum, Thyroidinum (Bovine), Argentum Nitricum, Bryonia (Alba), Calendula Officinalis, Cocculus Indicus, Glonoinum, Lac Defloratum, Nux Vomica, Petroleum, Tabacum, Belladonna, Theridion, Sanicula TABLET, ORALLY DISINTEGRATING ORAL 20160621 UNAPPROVED HOMEOPATHIC HelloLife, Inc. AMYL NITRITE; THYROID, BOVINE; SILVER NITRATE; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ANAMIRTA COCCULUS SEED; NITROGLYCERIN; SKIM MILK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; TOBACCO LEAF; ATROPA BELLADONNA; THERIDION CURASSAVICUM; WATER 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 49726-041_0db03ef7-0ade-447d-a293-2d11116b3ccb 49726-041 HUMAN OTC DRUG Synaptol Aconitum Ferox, Adrenalinum, Aesculus Hippocastanum, Flos, Apis Mellifica, Argentum Nitricum, Avena Sativa, Baptisia Tinctoria, Cochlearia Armoracia, Phosphorus, Scleranthus Annuus, Flos, Scutellaria Lateriflora, Sumbul, Viola Odorata TABLET, ORALLY DISINTEGRATING ORAL 20171211 UNAPPROVED HOMEOPATHIC HelloLife, Inc. ACONITUM FEROX ROOT; EPINEPHRINE; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; SILVER NITRATE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; HORSERADISH; PHOSPHORUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; FERULA SUMBUL ROOT; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 49730-111_56b49a42-bdf8-4582-8643-fe8c370d509e 49730-111 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089884 Hercon Laboratories Corporation NITROGLYCERIN .2 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 49730-112_56b49a42-bdf8-4582-8643-fe8c370d509e 49730-112 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089885 Hercon Laboratories Corporation NITROGLYCERIN .4 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 49730-113_56b49a42-bdf8-4582-8643-fe8c370d509e 49730-113 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin PATCH TRANSDERMAL 19981030 ANDA ANDA089886 Hercon Laboratories Corporation NITROGLYCERIN .6 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 49738-001_98d48ec8-ab28-4bfb-b3a4-497fa90bb0f9 49738-001 HUMAN OTC DRUG Smart Sense Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140218 ANDA ANDA075153 Kmart Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 49738-003_dfb72423-bd79-494d-b3d5-b85f91ecf698 49738-003 HUMAN OTC DRUG image essentials miconazole treatment Miconazole nitrate KIT 20150820 ANDA ANDA079114 Kmart Corporation N 20181231 49738-004_d4867f54-6844-41b0-9234-a94a6e50565a 49738-004 HUMAN OTC DRUG smart sense anti itch Hydrocortisone CREAM TOPICAL 20151209 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g N 20181231 49738-005_8ae787e9-66bb-4044-8d3e-a98104e9b473 49738-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Kmart Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 49738-007_499ecb69-6135-400b-a70b-89cf66dc33e1 49738-007 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20150131 OTC MONOGRAPH NOT FINAL part333A SMART SENSE (Kmart) ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 49738-008_a718fc01-4588-451f-9aa2-1d655f336ac8 49738-008 HUMAN OTC DRUG Smart Sense triple antibitotic plus pain relief Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20160329 OTC MONOGRAPH FINAL part333B Kmart Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 49738-009_d5df61ad-ce0a-4e1c-af46-d571d9d4c3bd 49738-009 HUMAN OTC DRUG smart sense sinus 12 hour Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150817 ANDA ANDA075153 Kmart Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 49738-011_6a09e769-a383-4b96-981f-5124cf59ae8a 49738-011 HUMAN OTC DRUG smart sense multi symptom fever and cold childrens Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20151023 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 49738-013_4b0cb030-9405-4468-9c4a-e4d99757e5dc 49738-013 HUMAN OTC DRUG Smart Sense allergy and congestion relief indoor and outdoor allergies Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20130510 ANDA ANDA076050 Kmart Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 49738-015_b3c00e3e-a55e-402b-844e-8802df55e533 49738-015 HUMAN OTC DRUG IMAGE ESSENTIALS ANTIBACTERIAL HAND MANDARIN AND GRAPEFRUIT TRICLOSAN LIQUID TOPICAL 20141123 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 1.5 mg/mL N 20181231 49738-017_a3df74d5-3819-46e0-8a51-f918e9cf7c0d 49738-017 HUMAN OTC DRUG smart sense itch stopping Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20151223 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 49738-018_2134157a-ba5f-42fa-a243-841a2196c0a4 49738-018 HUMAN OTC DRUG smart sense childrens pain relief Acetaminophen SUSPENSION ORAL 20150501 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 49738-019_1c0cef91-cfb1-4cc2-a5a8-d2bfbfeb3280 49738-019 HUMAN OTC DRUG smart sense sinus pe Phenylephrine Hydrochloride TABLET ORAL 20151223 OTC MONOGRAPH FINAL part341 Kmart Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 49738-023_bf4a35d3-08f3-4c90-b0a9-82825acabd36 49738-023 HUMAN OTC DRUG smart sense chewable aspirin Aspirin TABLET, CHEWABLE ORAL 20160314 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ASPIRIN 81 mg/1 N 20181231 49738-024_6d06ad74-e519-41bb-bdcc-56ac165ca249 49738-024 HUMAN OTC DRUG Extra Strength Pain Relief ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20160601 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 N 20181231 49738-025_25174042-ddd0-4320-8cba-0c257e7b6b71 49738-025 HUMAN OTC DRUG Smart Sense Pain Relief Acetaminophen TABLET, FILM COATED ORAL 20160127 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 N 20181231 49738-031_92031cad-72fa-4b00-a0f5-7eb19b722716 49738-031 HUMAN OTC DRUG Smart Sense Allergy Relief Cetirizine HCl SOLUTION ORAL 20160404 ANDA ANDA204226 Kmart Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 49738-033_4f3fe9fd-eb07-4aab-9015-f459c3fc8848 49738-033 HUMAN OTC DRUG smart sense PETROLATUM, LANOLIN OINTMENT TOPICAL 20150314 OTC MONOGRAPH FINAL part347 Kmart Corporation PETROLATUM; LANOLIN 53.4; 15.5 g/100g; g/100g N 20181231 49738-036_b3726cd0-5806-4baa-a551-3a8c891429d4 49738-036 HUMAN OTC DRUG sever daytime cold and flu and sever nighttime cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride KIT 20170712 OTC MONOGRAPH FINAL part341 Kmart Corporation N 20181231 49738-037_e9011575-8bcd-4d19-bf90-a58895eebe4a 49738-037 HUMAN OTC DRUG daytime cold and flu and nighttime cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride KIT 20170712 OTC MONOGRAPH FINAL part341 Kmart Corporation N 20181231 49738-050_7d0cc3a7-5ebf-4381-92c6-9d7eee6ee0cf 49738-050 HUMAN OTC DRUG Povidone Iodine povidone-iodine SOLUTION TOPICAL 20060913 OTC MONOGRAPH NOT FINAL part333A Kmart Corporation POVIDONE-IODINE .1 mg/mL E 20171231 49738-052_2faed564-3b82-4e76-b3fc-e7fa8deab430 49738-052 HUMAN OTC DRUG Smart Sense Nighttime Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20151021 OTC MONOGRAPH FINAL part338 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49738-054_34086c00-3796-4ebf-b7cc-bed4de186a38 49738-054 HUMAN OTC DRUG smart sense 12 hour decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110314 ANDA ANDA075153 Kmart Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 49738-061_f16e266f-cd94-461c-ad3d-77bde3d626fb 49738-061 HUMAN OTC DRUG image essentials tioconazole treatment Tioconazole OINTMENT VAGINAL 20141226 ANDA ANDA075915 Kmart Corporation TIOCONAZOLE 6.5 g/100g N 20181231 49738-062_b88c45b9-e359-44e6-bc95-7a8176248f9d 49738-062 HUMAN OTC DRUG Motion Sickness Relief Less Drowsy Meclizine HCl TABLET ORAL 20140228 OTC MONOGRAPH FINAL part336 SMART SENSE (Kmart) MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 49738-063_c92ddbe6-7689-40f0-a3e4-4d1306a4a10d 49738-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20090413 OTC MONOGRAPH FINAL part346 Kmart Corporation FERRIC OXIDE RED; ZINC OXIDE .8; .8 kg/100L; kg/100L N 20181231 49738-065_e393e370-59ed-488f-8424-2d9df1dd5ad9 49738-065 HUMAN OTC DRUG smart sense nasal extra moisturizing Oxymetazoline HCl SPRAY NASAL 20101112 OTC MONOGRAPH FINAL part341 Kmart Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 49738-071_cf6180f9-ca17-48a5-a957-8dbff8338671 49738-071 HUMAN OTC DRUG Multi Symptom Cold and Flu Relief Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20160731 OTC MONOGRAPH FINAL part341 SMART SENSE (Kmart) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 49738-077_4ccaa0fa-0b84-4b38-b6b1-9eba4e36535f 49738-077 HUMAN OTC DRUG Aspirin Low Dose Enteric Coated Aspirin TABLET ORAL 20130331 OTC MONOGRAPH FINAL part343 SMART SENSE (Kmart) ASPIRIN 81 mg/1 N 20181231 49738-078_f040213c-135b-4bee-9e29-c79321fe0c2a 49738-078 HUMAN OTC DRUG LITTLE ONES ORIGINAL ETHYL ALCOHOL LIQUID TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 700 mg/mL N 20181231 49738-079_03bb27e2-67c0-41ad-89a1-ea5eab4da5b8 49738-079 HUMAN OTC DRUG SMART SENSE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131107 OTC MONOGRAPH NOT FINAL part333E KMARTK CORPORATION ALCOHOL 700 mg/mL N 20181231 49738-079_14f2ec7e-b403-4016-ad4f-cbf611bdedc4 49738-079 HUMAN OTC DRUG SMART SENSE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20150708 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 700 mg/mL N 20181231 49738-079_70156c58-74a0-46d5-ba10-4ae9723285c8 49738-079 HUMAN OTC DRUG SMART SENSE ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131107 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 700 mg/mL N 20181231 49738-080_23d9e230-e477-4348-baf4-eb89aa6a067c 49738-080 HUMAN OTC DRUG LITTLE ONES LAVENDER ETHYL ALCOHOL LIQUID TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 700 mg/mL N 20181231 49738-084_5388a805-640f-473e-ab1c-f1f50724d54a 49738-084 HUMAN OTC DRUG smart sense hair regrowth Minoxidil AEROSOL, FOAM TOPICAL 20170227 ANDA ANDA091344 Kmart Corporation MINOXIDIL 5 g/100g N 20181231 49738-086_499cae2f-13a0-45ec-af9c-aab2e35e4139 49738-086 HUMAN OTC DRUG smart sense Ultra Strength CAMPHOR, MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20150315 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g N 20181231 49738-088_407551ab-cff8-4463-9b3c-c0778adf9ee5 49738-088 HUMAN OTC DRUG Smart Sense Tioconazole 1 Tioconazole OINTMENT VAGINAL 20160628 ANDA ANDA075915 Kmart Corporation TIOCONAZOLE 6.5 g/100g N 20181231 49738-091_1f345537-691e-4c39-befb-bdc9ccd011a8 49738-091 HUMAN OTC DRUG Smart Sense Dual Action Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160201 ANDA ANDA077355 Kmart Corporation FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 49738-094_4fbafdb0-762e-431f-91a1-3791ecfec4b8 49738-094 HUMAN OTC DRUG Smart Sense nasal decongestant pe maximum strength Phenylephrine Hydrochloride TABLET ORAL 20101229 OTC MONOGRAPH FINAL part341 Kmart Corporation PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 49738-100_5c313084-fd5d-48f1-a223-3313b093a527 49738-100 HUMAN OTC DRUG IMAGE ESSENTIALS SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 4.6 mg/mL N 20181231 49738-100_fccef42e-a9ea-4e52-b0dd-99ff75d586c7 49738-100 HUMAN OTC DRUG IMAGE ESSENTIALS SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 4.6 mg/mL N 20181231 49738-101_ac089b6c-873b-4c01-9b17-b5804fa64e5a 49738-101 HUMAN OTC DRUG IMAGE ESSENTIALS SPRING FRESH TRICLOSAN LIQUID TOPICAL 20131120 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 4.6 mg/mL N 20181231 49738-103_7006cef1-04da-4f8e-a171-5f9ac277697d 49738-103 HUMAN OTC DRUG smart sense sinus Pseudoephedrine HCl TABLET, FILM COATED ORAL 20150827 OTC MONOGRAPH FINAL part341 Kmart Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 49738-104_662adc51-02f9-4d55-820e-47a4b4c99c2f 49738-104 HUMAN OTC DRUG daytime nighttime severe cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl KIT 20170817 OTC MONOGRAPH FINAL part341 Kmart Corporation N 20181231 49738-109_3698e096-4881-40d8-a5bf-1dc98b3e3919 49738-109 HUMAN OTC DRUG Mucus DM Dextromethorphan Hydrobromide and Guaifenesin TABLET ORAL 20140131 OTC MONOGRAPH FINAL part341 SMART SENSE (Kmart) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 49738-111_bd389554-c994-4c05-89a0-b0a6845a1324 49738-111 HUMAN OTC DRUG Oral Saline Laxative Ginger Lemon dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120831 OTC MONOGRAPH NOT FINAL part334 Kmart Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.7; 7.2 g/15mL; g/15mL E 20171231 49738-118_eac3922f-c494-4da5-92cf-f2f5a196e968 49738-118 HUMAN OTC DRUG smart sense allergy and congestion relief d Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20150729 ANDA ANDA076050 Kmart Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 49738-120_0dfcd931-fdfe-420b-b48e-37ba604ad205 49738-120 HUMAN OTC DRUG Womens Gentle Laxative Bisacodyl TABLET, COATED ORAL 20141231 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) BISACODYL 5 mg/1 N 20181231 49738-129_971b1158-cb43-4de6-9ddf-4f14625f89ca 49738-129 HUMAN OTC DRUG Smart Sense antibiotic plus pain relief Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20160920 OTC MONOGRAPH FINAL part333B Kmart Corporation NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g N 20181231 49738-138_57c5ff84-f115-44e9-a9bf-769dbb5dc51f 49738-138 HUMAN OTC DRUG Smart Sense Anti Itch hydrocortisone OINTMENT TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g N 20181231 49738-140_1e822fee-0d52-4422-84a7-c6e041f05d92 49738-140 HUMAN OTC DRUG smart sense naproxen sodium Naproxen sodium TABLET, FILM COATED ORAL 20101001 ANDA ANDA074661 Kmart Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 49738-142_46e38ad1-90d4-48d4-8c9a-68ccc71912a9 49738-142 HUMAN OTC DRUG smart sense vagicaine maximum strength Benzocaine, Resorcinol CREAM TOPICAL 20110223 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g N 20181231 49738-143_1f8f8013-783d-44d5-a5c0-f221c59cc9cb 49738-143 HUMAN OTC DRUG smart sense cough and chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20150930 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 49738-149_572b1caf-a328-48f8-805d-3fee4039828b 49738-149 HUMAN OTC DRUG smart sense mucus and chest congestion Guaifenesin SOLUTION ORAL 20151012 OTC MONOGRAPH FINAL part341 Kmart Corporation GUAIFENESIN 200 mg/10mL N 20181231 49738-150_e260a19e-cbd4-4350-b01c-58cadbf62870 49738-150 HUMAN OTC DRUG Stool Softener Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) DOCUSATE SODIUM 250 mg/1 N 20181231 49738-154_07af2413-edd0-4611-bff5-7d01b6a8691d 49738-154 HUMAN OTC DRUG Smart Sense Athletes Foot tolnaftate SPRAY TOPICAL 20110421 OTC MONOGRAPH FINAL part333C Kmart Corporation TOLNAFTATE 1 g/100g N 20181231 49738-160_dd1e5abc-8d09-4832-8521-fb7627323f0b 49738-160 HUMAN OTC DRUG Senna S docusate sodium and sennosides TABLET ORAL 20121231 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 49738-161_4d636c18-a5ae-3e94-e054-00144ff8d46c 49738-161 HUMAN OTC DRUG Smart Sense Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% LIQUID TOPICAL 20160101 NDA NDA019125 Kmart Corporation CHLORHEXIDINE GLUCONATE 2 g/100mL N 20181231 49738-166_e415bf48-7001-41df-83b7-e12dfe471cec 49738-166 HUMAN OTC DRUG Smart Sense ibuprofen Ibuprofen SUSPENSION ORAL 20100520 ANDA ANDA074937 Kmart Corporation IBUPROFEN 100 mg/5mL N 20181231 49738-168_b1a6a2d7-3244-4df1-b873-62a945159742 49738-168 HUMAN OTC DRUG ANTIBACTERIAL FOAMING REFILL TRICLOSAN LIQUID TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .46 mL/100mL N 20181231 49738-173_5daf3e12-7837-4a8c-bd65-cc4fa70450ed 49738-173 HUMAN OTC DRUG Smart Sense lice control Piperonyl butoxide, pyrethrum extract KIT 20170530 OTC MONOGRAPH FINAL part358G Kmart Corporation N 20181231 49738-174_370fb4d7-a448-48d8-98e0-b8ec8391086d 49738-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141231 NDA NDA021920 SMART SENSE (Kmart) NAPROXEN SODIUM 220 mg/1 N 20181231 49738-175_49df8b90-f803-47b8-b1a6-76b9995772a2 49738-175 HUMAN OTC DRUG smart sense pain relief childrens Acetaminophen SUSPENSION ORAL 20100715 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 49738-176_d5b9925d-96c4-488e-8e2e-22a14d0e3d76 49738-176 HUMAN OTC DRUG Smart Sense All Day Allergy D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20110314 ANDA ANDA077170 Kmart Corporation CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 49738-177_55f977de-3fcd-4da9-a0c4-21ee0df9d919 49738-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110516 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .46 mL/100mL N 20181231 49738-178_b030f080-38bf-437c-9b41-0a11ba59854f 49738-178 HUMAN OTC DRUG Kmart Corporation Healthy Protection Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 Kmart Corporation STANNOUS FLUORIDE .454 g/100g N 20181231 49738-182_dd3992c9-e060-4f2b-97dc-71f11574a7a7 49738-182 HUMAN OTC DRUG Smart Sense Hydrocortisone Hydrocortisone CREAM TOPICAL 20131217 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g N 20181231 49738-184_0fc266ea-375f-43e5-b82f-b3fb6d0a2cf3 49738-184 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20120619 OTC MONOGRAPH NOT FINAL part343 SMART SENSE (Kmart) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 49738-186_dd7c1f05-e234-4bb3-96bf-ae06318b7daa 49738-186 HUMAN OTC DRUG Smart Sense Nighttime Sleep Aid Diphenhydramine HCl SOLUTION ORAL 20151021 OTC MONOGRAPH FINAL part338 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20191231 49738-188_a02077bd-b22f-4f77-8690-34864649d593 49738-188 HUMAN OTC DRUG smart sense hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140324 OTC MONOGRAPH FINAL part346 Kmart Corporation MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 49738-189_befba295-f3e5-4ff7-a337-315fb54966cc 49738-189 HUMAN OTC DRUG Smart Sense Childrens Allergy Cetirizine HCl SOLUTION ORAL 20140102 ANDA ANDA204226 Kmart Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 49738-191_cd0e92b2-a574-444b-8885-44044da910ab 49738-191 HUMAN OTC DRUG smart sense ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20100527 ANDA ANDA079113 Kmart Corporation DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 49738-194_413c7671-f223-4ab7-88da-59225771d954 49738-194 HUMAN OTC DRUG Smart Sense Acid Reducer Maximum Strength Famotidine TABLET ORAL 20101221 ANDA ANDA077351 Kmart Corporation FAMOTIDINE 20 mg/1 N 20181231 49738-198_4e984d46-212e-414f-bdd9-90121a87432e 49738-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120930 ANDA ANDA078682 SMART SENSE (Kmart) IBUPROFEN 200 mg/1 N 20181231 49738-199_2f94474b-a033-4746-8a0a-de90b6c95ed5 49738-199 HUMAN OTC DRUG Smart Sense miconazole 1 Miconazole nitrate KIT 20100616 ANDA ANDA079114 Kmart Corporation N 20181231 49738-200_fe437e83-2817-465f-b3cb-b2dd5fd16ec1 49738-200 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333A Kmart Corporation BENZALKONIUM CHLORIDE .13 mL/mL E 20171231 49738-201_1afd815b-6502-41eb-870a-5af70a1e1d14 49738-201 HUMAN OTC DRUG smart sense famotidine Famotidine TABLET ORAL 20140218 ANDA ANDA075400 Kmart Corporation FAMOTIDINE 10 mg/1 N 20181231 49738-202_8c2c3744-32dd-4648-9517-cfcdcd3ceae4 49738-202 HUMAN OTC DRUG image essentials hair regrowth treatment minoxidil SOLUTION TOPICAL 20110620 ANDA ANDA075357 Kmart Corporation MINOXIDIL 2 g/100mL N 20181231 49738-203_33cd868e-4af1-466c-9a4b-7734f9cbb83d 49738-203 HUMAN OTC DRUG Smart Sense Triple Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140519 OTC MONOGRAPH FINAL part333B Kmart Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 49738-211_778659a3-092f-42ba-8975-7e321fc9c2cd 49738-211 HUMAN OTC DRUG Cetirizine HCl Cetirizine Hydrochloride CAPSULE ORAL 20130501 NDA NDA022429 SMART SENSE (Kmart) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 49738-215_365013d1-6f01-4d6b-aabb-80ae1e0c63d5 49738-215 HUMAN OTC DRUG ANTIBACTERIAL MANDARIN AND GRAPEFRUIT TRICLOSAN LIQUID TOPICAL 20110707 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .15 mL/100mL N 20181231 49738-216_857d3687-f334-4d2c-a8a6-3ab8cf3cc9f2 49738-216 HUMAN OTC DRUG ANTIBACTERIAL REFILL TRICLOSAN LIQUID TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .15 L/100L N 20181231 49738-216_daaf0bba-5114-4699-81a6-a56ff7910227 49738-216 HUMAN OTC DRUG ANTIBACTERIAL REFILL TRICLOSAN LIQUID TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .15 L/100L N 20181231 49738-217_5246ed7d-ca4f-4e19-a35a-50f72d975cb1 49738-217 HUMAN OTC DRUG smart sense pain relief 8 hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101022 ANDA ANDA075077 Kmart Corporation ACETAMINOPHEN 650 mg/1 N 20181231 49738-219_a12b0684-f86f-4f88-becb-bfa419afe578 49738-219 HUMAN OTC DRUG Anti-Itch Scherer Labs Hydrocortisone 1.00% SPRAY TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g N 20181231 49738-220_bdcff56d-93b1-4048-b857-f192af4e0d89 49738-220 HUMAN OTC DRUG Image Essentials Antibacterial Gold TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Kmart Corporation TRICLOSAN .15 mL/100mL N 20181231 49738-227_d8ad2666-2ba3-4aee-8657-ccbea131fd96 49738-227 HUMAN OTC DRUG Smart Sense pain relief extra strength Acetaminophen TABLET, COATED ORAL 20101215 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 N 20181231 49738-230_12d50c85-548a-4158-ad8d-84e730d75f80 49738-230 HUMAN OTC DRUG Nighttime Sleep-Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20130331 OTC MONOGRAPH FINAL part341 SMART SENSE (Kmart) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 49738-236_f98d691f-ad44-4f4e-84b1-1c2dd812b7fa 49738-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 SMART SENSE (Kmart) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 49738-237_64885319-a36f-4d1a-90dd-271143a2a7b4 49738-237 HUMAN OTC DRUG smart sense childrens pain relief Acetaminophen SUSPENSION ORAL 20140312 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 49738-238_c396bf67-563f-4e7f-bc70-3846fc151b7c 49738-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) DOCUSATE SODIUM 100 mg/1 N 20181231 49738-242_5ad6fcd4-1057-40b0-9c5c-2de7b00dbe36 49738-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20141231 OTC MONOGRAPH FINAL part347 SMART SENSE (Kmart) DIMETHICONE 125 mg/1 N 20181231 49738-244_f0598967-2bc7-4e3d-a404-ccb014976e9a 49738-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) DOCUSATE SODIUM 100 mg/1 N 20181231 49738-247_08c69a22-058b-4311-8e33-d48c83027082 49738-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20141231 OTC MONOGRAPH NOT FINAL part343 SMART SENSE (Kmart) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 49738-252_ab8091c9-165e-4958-9656-135f517ffc99 49738-252 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl, TABLET ORAL 20140331 OTC MONOGRAPH FINAL part338 SMART SENSE (Kmart) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49738-255_7f838987-a4ed-4b62-8446-eb764be4c1c8 49738-255 HUMAN OTC DRUG smart sense ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20100514 ANDA ANDA075217 Kmart Corporation IBUPROFEN 50 mg/1.25mL N 20181231 49738-258_5addf9ba-48ed-488a-bd95-e67e0c1ca652 49738-258 HUMAN OTC DRUG STOOL SOFTENER Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) DOCUSATE SODIUM 250 mg/1 N 20181231 49738-268_32a57aa4-8b01-4020-bb99-9abc041c1d1e 49738-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20150131 OTC MONOGRAPH NOT FINAL part356 SMART SENSE (Kmart) HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 49738-269_bf2e978d-b7b2-4600-98c5-ffc38a8f83b0 49738-269 HUMAN OTC DRUG Image Essentials Vagicaine Benzocaine, Resorcinol CREAM TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g N 20181231 49738-272_a99fe2da-46b5-489f-a223-0f4dee99391c 49738-272 HUMAN OTC DRUG smart sense sinus Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20101203 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 49738-274_6384f623-d152-401d-838d-84fd9caac7cd 49738-274 HUMAN OTC DRUG smart sense aspirin Aspirin TABLET, CHEWABLE ORAL 20100604 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ASPIRIN 81 mg/1 N 20181231 49738-275_14698cae-8224-4a87-879a-701c426b7284 49738-275 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20150131 OTC MONOGRAPH NOT FINAL part333A SMART SENSE (Kmart) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 49738-276_ccfed75e-da11-4061-bad5-bc15160d207a 49738-276 HUMAN OTC DRUG Isopropyl alcohol 70 percent Wintergreen Isopropyl alcohol LIQUID TOPICAL 20150131 OTC MONOGRAPH NOT FINAL part333A SMART SENSE (Kmart) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 49738-279_2c96b322-f06f-41e8-aa88-e931ddea3ced 49738-279 HUMAN OTC DRUG smart sense hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141002 OTC MONOGRAPH FINAL part346 Kmart Corporation COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 49738-280_61cab3eb-d902-4f11-9827-1235007a15af 49738-280 HUMAN OTC DRUG smart sense multi symptom cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20151012 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 49738-284_d1e8b3d5-4adf-4229-805d-9fb1fe912de6 49738-284 HUMAN OTC DRUG Smart Sense Bacitracin Bacitracin OINTMENT TOPICAL 20160520 OTC MONOGRAPH FINAL part333B Kmart Corporation BACITRACIN 500 [USP'U]/g N 20181231 49738-288_530d65e4-515b-4281-b1c0-025a1dce86b2 49738-288 HUMAN OTC DRUG Smart Sense Childrens Mucus Relief Guaifenesin SOLUTION ORAL 20101203 OTC MONOGRAPH FINAL part341 Kmart Corporation GUAIFENESIN 100 mg/5mL N 20181231 49738-291_e01f9ebd-c204-4eb6-b1ef-0ef927666078 49738-291 HUMAN OTC DRUG Smart Sense nausea relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20150914 UNAPPROVED DRUG OTHER Kmart Corporation DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 49738-294_08b887f5-8bff-4723-a88f-3adfb6cf2c24 49738-294 HUMAN OTC DRUG ANTIBACTERIAL REFILL TRICLOSAN LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .15 L/100L N 20181231 49738-294_55460a49-667c-4346-b003-dd583911d096 49738-294 HUMAN OTC DRUG ANTIBACTERIAL REFILL TRICLOSAN LIQUID TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .15 L/100L N 20181231 49738-294_fb8d3933-9aa6-4054-b420-562be1e48834 49738-294 HUMAN OTC DRUG ANTIBACTERIAL REFILL TRICLOSAN LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .15 L/100L N 20181231 49738-295_7467d8eb-69a1-49fb-b6ba-e47eab3b4ae4 49738-295 HUMAN OTC DRUG SMART SENSE TOLNFTATE ANTIFUNGAL TOLNAFTATE CREAM TOPICAL 20111114 OTC MONOGRAPH FINAL part333C KMART CORPORATION TOLNAFTATE 10 mg/g E 20171231 49738-296_b998fd1f-8c57-485f-813b-f1ed1fddd824 49738-296 HUMAN OTC DRUG Smart Sense Cold and Hot Extra Strength Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation MENTHOL 750 mg/1 N 20181231 49738-298_af432e3f-e862-4373-98e4-c2c83deb6e93 49738-298 HUMAN OTC DRUG IMAGE ESSENTIALS SPRING FRESH TRICLOSAN LIQUID TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 1.5 mg/mL N 20181231 49738-299_c51e07cb-42ec-49dd-9706-2307986f6be5 49738-299 HUMAN OTC DRUG Smart Sense Famotidine Famotidine TABLET ORAL 20140207 ANDA ANDA077351 Kmart Corporation FAMOTIDINE 20 mg/1 N 20181231 49738-300_51bca0e5-0bdf-46df-bec6-870a72a2861a 49738-300 HUMAN OTC DRUG Image Essentials Hair Regrowth Treatment For Men Minoxidil AEROSOL, FOAM TOPICAL 20120716 ANDA ANDA091344 Kmart Corporation MINOXIDIL 5 g/100g N 20181231 49738-303_60e0bd48-25e1-432e-96e2-4ecbeb8d9f08 49738-303 HUMAN OTC DRUG Smart Sense Allergy Relief Fluticasone propionate SPRAY, METERED NASAL 20160610 ANDA ANDA207957 Kmart Corporation FLUTICASONE PROPIONATE 50 ug/1 N 20181231 49738-304_5691c9df-1d4b-4bba-894e-2da7527304bb 49738-304 HUMAN OTC DRUG smart sense nasal original oxymetazoline hydrochloride SPRAY NASAL 20100903 OTC MONOGRAPH FINAL part341 Kmart Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 49738-306_eb310fd4-9d78-4360-bff3-e8dfcaac6320 49738-306 HUMAN OTC DRUG Smart Sense Clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20110407 ANDA ANDA090685 Kmart Corporation POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 49738-317_c9f0bdf9-8d27-4887-a8bf-de46f1faeb76 49738-317 HUMAN OTC DRUG Smart Sense Chewable Aspirin Aspirin TABLET, CHEWABLE ORAL 20160823 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ASPIRIN 81 mg/1 N 20181231 49738-319_8997f53c-e721-4b8b-a2c4-ee4e76d0507b 49738-319 HUMAN OTC DRUG Smart sense Hydrocortisone Hydrocortisone CREAM TOPICAL 20150708 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g N 20181231 49738-320_ecc34f8e-3746-49fa-a086-e7c8f6eaec1f 49738-320 HUMAN OTC DRUG IMAGE ESSENTIALS OATMEAL MOISTURIZING DIMETHICONE LOTION TOPICAL 20140225 OTC MONOGRAPH FINAL part347 KMART CORPORATION DIMETHICONE 12.5 mg/mL N 20181231 49738-325_8b71fc58-0972-43f5-ae39-c66fbd186924 49738-325 HUMAN OTC DRUG Smart Sense Mucus Relief ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160901 ANDA ANDA091009 Kmart Corporation GUAIFENESIN 1200 mg/1 N 20181231 49738-326_7e9129e5-bc23-4c5e-8c0d-909c20ed0c3f 49738-326 HUMAN OTC DRUG Magnesium Citrate Saline Laxative Magnesium citrate LIQUID ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49738-329_e0b5a5c6-0e32-4e30-84ac-42aca5aea217 49738-329 HUMAN OTC DRUG Magnesium Citrate Lemon Magnesium citrate LIQUID ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 49738-334_eea7cf19-1501-410d-97c5-3d79d071ae07 49738-334 HUMAN OTC DRUG Mineral oil Mineral oil OIL ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) MINERAL OIL 100 mg/100mL N 20181231 49738-335_088d0e5a-1570-480e-a140-8cb212cde754 49738-335 HUMAN OTC DRUG smart sense nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20120508 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 49738-339_bc7a4cae-985d-420b-aff1-78d1c69f693c 49738-339 HUMAN OTC DRUG KMart Smart Sense Benzocaine PASTE, DENTIFRICE TOPICAL 20131201 OTC MONOGRAPH FINAL part333B KMart BENZOCAINE 20 g/100g N 20181231 49738-340_b53ea917-dbb1-4bcb-a685-0c87143fee5b 49738-340 HUMAN OTC DRUG Hygienic Cleansing Pads witch hazel SOLUTION TOPICAL 20060822 OTC MONOGRAPH FINAL part346 Kmart Corporation WITCH HAZEL .5 mL/mL E 20171231 49738-350_7eac48fb-b063-4145-9595-d4867df6bb59 49738-350 HUMAN OTC DRUG IMAGE ESSENTIALS WHITE PETROLATUM JELLY TOPICAL 20130610 OTC MONOGRAPH FINAL part346 KMART CORPORATION PETROLATUM 1000 mg/g N 20181231 49738-350_da7b2821-43aa-451c-b3e5-9f76924b5993 49738-350 HUMAN OTC DRUG IMAGE ESSENTIALS WHITE PETROLATUM JELLY TOPICAL 20150505 OTC MONOGRAPH FINAL part346 KMART CORPORATION PETROLATUM 1000 mg/g N 20181231 49738-351_69d7da0e-9fd7-4d36-a5d4-b9bdb5727796 49738-351 HUMAN OTC DRUG LITTLE ONES PETROLEUM PETROLATUM JELLY TOPICAL 20150427 OTC MONOGRAPH FINAL part347 KMART CORPORATION PETROLATUM 1000 mg/g N 20181231 49738-361_3aaf662a-fc5f-4c9d-ac4e-b5c134d207eb 49738-361 HUMAN OTC DRUG smart sense ranitidine Ranitidine TABLET, FILM COATED ORAL 20140321 ANDA ANDA091429 Kmart Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 49738-368_c08ad15e-1c1b-45cd-a074-3926b5d67df6 49738-368 HUMAN OTC DRUG Smart Sense Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20101008 ANDA ANDA074661 Kmart Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 49738-369_22c02b10-8ada-484f-8d06-4c77285ec477 49738-369 HUMAN OTC DRUG smart sense anti itch maximum strength Hydrocortisone CREAM TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g N 20181231 49738-374_93d0f7ef-d74e-4c23-bc54-effe21092396 49738-374 HUMAN OTC DRUG Smart Sense migraine relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20100527 ANDA ANDA075794 Kmart Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 49738-376_13b353fb-b03f-499a-a91d-294d81f449d0 49738-376 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20141130 OTC MONOGRAPH NOT FINAL part356 SMART SENSE (Kmart) PHENOL 1.4 g/100mL N 20181231 49738-381_a5d67b44-0978-4296-b1fd-433f70889b04 49738-381 HUMAN OTC DRUG Smart Sense cold flu and sore throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20151128 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49738-383_d13f069f-a78c-48c6-947e-d1e2499d1bf3 49738-383 HUMAN OTC DRUG Smart Sense anti diarrheal loperamide HCl SUSPENSION ORAL 20160126 ANDA ANDA091292 Kmart Corporation LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 49738-384_95dc9ca8-bcc2-40da-bd50-37dc75fedc88 49738-384 HUMAN OTC DRUG Smart Sense Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130805 ANDA ANDA091135 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 49738-385_c7515bfc-b5c7-4557-bf73-e505d072347a 49738-385 HUMAN OTC DRUG Smart Sense Hair Regrowth Minoxidil SOLUTION TOPICAL 20170508 ANDA ANDA075598 Kmart Corporation MINOXIDIL 3 g/60mL N 20181231 49738-390_b4cf24d2-5fe8-4c68-990b-5afdcc3f4a2b 49738-390 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20150131 OTC MONOGRAPH FINAL part347 SMART SENSE (Kmart) WITCH HAZEL 473 mg/mL N 20181231 49738-392_ab328178-2bae-4b45-97cf-d3138e828af4 49738-392 HUMAN OTC DRUG Smart Sense Athletes Foot Relief tolnaftate SPRAY TOPICAL 20110421 OTC MONOGRAPH FINAL part333C Kmart Corporation TOLNAFTATE 1 g/100g N 20181231 49738-395_d0306502-234a-45bc-8f3c-6d6d20dea6c4 49738-395 HUMAN OTC DRUG Epsom Salt Magnesium sulfate GRANULE ORAL; TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) MAGNESIUM SULFATE, UNSPECIFIED 1 g/g N 20181231 49738-397_06b40618-5365-402e-8d0a-43f3486f5929 49738-397 HUMAN OTC DRUG Smart Sense Childrens Pain Relief Acetaminophen SUSPENSION ORAL 20130805 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 49738-399_c3369b57-adf7-48aa-af05-0def2857a2ce 49738-399 HUMAN OTC DRUG Smart Sense Arthritis Trolamine Salicylate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation TROLAMINE SALICYLATE 10 g/100g N 20181231 49738-401_d9a67b78-0e77-45a9-9149-8c005d657138 49738-401 HUMAN OTC DRUG smart sense lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20151228 ANDA ANDA202319 Kmart Corporation LANSOPRAZOLE 15 mg/1 N 20181231 49738-403_a64f2ce5-5bff-46d6-9c84-d3f3084d89fd 49738-403 HUMAN OTC DRUG Smart Sense Miconazole 1 Miconazole nitrate KIT 20160817 ANDA ANDA079114 Kmart Corporation N 20181231 49738-405_6ccc6e10-97a3-495a-9e15-bae011a655ca 49738-405 HUMAN OTC DRUG Smart Sense Hand Sanitizer Lychee Berry Ethyl Alcohol LIQUID TOPICAL 20161003 OTC MONOGRAPH NOT FINAL part333E Kmart Corporation ALCOHOL 650 mg/mL N 20181231 49738-407_fc6275e2-7e0d-4e22-b30b-adefd6436042 49738-407 HUMAN OTC DRUG Smart Sense Cold Sore Treatment Benzalkonium chloride CREAM TOPICAL 20130408 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; ug/g N 20181231 49738-408_0add8e2a-d0d8-4655-bc18-3ec5d3de4698 49738-408 HUMAN OTC DRUG Smart Sense Hand Sanitizer Cotton Breeze Ethyl Alcohol LIQUID TOPICAL 20161003 OTC MONOGRAPH NOT FINAL part333E Kmart Corporation ALCOHOL 650 mg/mL N 20181231 49738-409_5a86338c-04ed-4c09-9df1-55b8159caa11 49738-409 HUMAN OTC DRUG Smart Sense Stay Awake Caffeine TABLET ORAL 20101216 OTC MONOGRAPH FINAL part340 Kmart Corporation CAFFEINE 200 mg/1 N 20181231 49738-413_00ee3b51-83ef-44b0-8d5f-ef997d59410d 49738-413 HUMAN OTC DRUG Little Ones Baby Fresh Sanitizer Ethyl Alcohol LIQUID TOPICAL 20170522 OTC MONOGRAPH NOT FINAL part333E Kmart Corporation ALCOHOL 650 mg/mL N 20181231 49738-413_fe5f18a2-c727-4650-a469-14621f82e574 49738-413 HUMAN OTC DRUG LITTLE ONES BABY FRESH SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20150427 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 650 mg/mL N 20181231 49738-419_394bf8e1-f1e9-48e1-9725-6a50fc690ba9 49738-419 HUMAN OTC DRUG Smart Sense Mucus Relief Cough Childrens Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 20101209 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 49738-424_64cc0999-faca-459d-8076-0468458599bb 49738-424 HUMAN OTC DRUG Smart Sense Tolnaftate Antifungal Tolnaftate CREAM TOPICAL 20140923 OTC MONOGRAPH FINAL part333C Kmart Corporation TOLNAFTATE 10 mg/g E 20171231 49738-425_f1143a34-1bb8-42b2-a238-c003e150f6c5 49738-425 HUMAN OTC DRUG smart sense allergy relief Fexofenadine HCl TABLET, FILM COATED ORAL 20110901 ANDA ANDA076447 Kmart Corporation FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 49738-426_54b2355b-84c4-45a6-854e-f2c2501725e8 49738-426 HUMAN OTC DRUG Smart Sense Tioconazole 1 Tioconazole OINTMENT VAGINAL 20110711 ANDA ANDA075915 Kmart Corporation TIOCONAZOLE 6.5 g/100g N 20181231 49738-429_34a7f994-6d3a-47b2-a850-e6e09cc7134c 49738-429 HUMAN OTC DRUG Smart Sense Anti Gas Simethicone CAPSULE, LIQUID FILLED ORAL 20140318 OTC MONOGRAPH FINAL part332 Kmart Corporation DIMETHICONE 180 mg/1 N 20181231 49738-431_fc61e21d-6139-4f82-b505-58ae12e49a1f 49738-431 HUMAN OTC DRUG smart sense nightime sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20070629 OTC MONOGRAPH FINAL part338 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49738-432_eced7c46-2104-480a-84d4-03ce46e3c8d5 49738-432 HUMAN OTC DRUG Smart Sense Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20110314 OTC MONOGRAPH FINAL part341 Kmart Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 49738-441_053199cc-de97-44c4-abd1-c5ee78dfa023 49738-441 HUMAN OTC DRUG smart sense sleep aid Doxylamine succinate TABLET ORAL 20101229 ANDA ANDA040167 Kmart Corporation DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 49738-443_6c110ab7-782d-48e4-8c89-c6b2fc9fe1a8 49738-443 HUMAN OTC DRUG Smart Sense Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20170208 ANDA ANDA078104 Kmart Corporation TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 49738-444_1ac78d45-7499-4ffb-8217-c6be7908e568 49738-444 HUMAN OTC DRUG Smart Sense Migraine Formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20140417 ANDA ANDA075794 Kmart Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 49738-453_2c80033d-0fd1-4e6e-a6de-46761491a4cf 49738-453 HUMAN OTC DRUG Smart Sense Childrens Nighttime Cold and Cough Diphenhydramine HCl, Phenylephrine HCl SOLUTION ORAL 20140418 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 49738-458_76dc9367-a74d-4223-8c9a-0f6371cd6351 49738-458 HUMAN OTC DRUG Smart Sense all day allergy Cetirizine Hydrochloride TABLET ORAL 20110118 ANDA ANDA078336 Kmart Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 49738-459_3cc505c4-221f-4a92-9c78-682c4e74cc7a 49738-459 HUMAN OTC DRUG smart sense nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110913 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 49738-461_fa7aa278-eb0b-4e81-909d-161764355b58 49738-461 HUMAN OTC DRUG smart sense ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20100624 ANDA ANDA076359 Kmart Corporation IBUPROFEN 100 mg/1 N 20181231 49738-466_9a8023e3-bb70-4bcd-8044-727ee8666ff9 49738-466 HUMAN OTC DRUG Smart Sense Childrens allergy relief Diphenhydramine HCl SOLUTION ORAL 20140221 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 49738-467_8f9a11a9-070a-4db2-ae1e-863da0ba66e8 49738-467 HUMAN OTC DRUG Smart Sense Aspirin Aspirin TABLET, CHEWABLE ORAL 20100604 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ASPIRIN 81 mg/1 N 20181231 49738-470_802346bf-5546-41a8-ad3a-68b884dcb946 49738-470 HUMAN OTC DRUG DayTime Cold Flu Non-Drowsy ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20121231 OTC MONOGRAPH FINAL part341 SMART SENSE (Kmart) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 49738-471_5c43c60c-898f-452b-b1d0-f08204d1aefc 49738-471 HUMAN OTC DRUG Smart Sense Ranitidine Ranitidine TABLET, FILM COATED ORAL 20110527 ANDA ANDA091429 Kmart Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 49738-475_76510ab2-8044-46c5-954c-df20bd5d7ab2 49738-475 HUMAN OTC DRUG smart sense allergy relief childrens Cetirizine HCl SOLUTION ORAL 20151021 ANDA ANDA204226 Kmart Corporation CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 49738-476_c3374bc6-d388-4e78-982d-6d0ab57279e3 49738-476 HUMAN OTC DRUG Smart Sense Sleep Aid Diphenhydramine Hydrochloride TABLET ORAL 20140418 OTC MONOGRAPH FINAL part338 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49738-478_52811813-36dd-4321-9341-a8ad3ad30f27 49738-478 HUMAN OTC DRUG SMART SENSE ORIGINAL ETHYL ALCOHOL LIQUID TOPICAL 20160308 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 700 mg/mL N 20181231 49738-478_5ad647b7-4404-4b02-84aa-b11b1516ad67 49738-478 HUMAN OTC DRUG SMART SENSE ORIGINAL ETHYL ALCOHOL LIQUID TOPICAL 20131107 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 700 mg/mL N 20181231 49738-479_c2c6f4cc-c190-4cda-8b67-2951e07e75d5 49738-479 HUMAN OTC DRUG smart sense allergy Diphenhydramine Hydrochloride TABLET ORAL 20110106 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49738-480_987551e2-ccc3-4c98-b2a7-4ab382be559c 49738-480 HUMAN OTC DRUG Nighttime cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20121231 OTC MONOGRAPH FINAL part341 SMART SENSE (Kmart) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 49738-482_d5bbfcab-e4e6-46ef-98ad-5069bf677cb5 49738-482 HUMAN OTC DRUG SMART SENSE VITAMIN E SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION ALCOHOL 700 mg/mL N 20181231 49738-483_1100f854-f15f-4862-9505-e1582a200e1e 49738-483 HUMAN OTC DRUG Allergy Relief Dye Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20160731 OTC MONOGRAPH FINAL part341 SMART SENSE (Kmart) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49738-484_ce6c93be-958c-4662-ac57-07ad1a92c733 49738-484 HUMAN OTC DRUG Smart Sense pain relief extra strength Acetaminophen TABLET ORAL 20100520 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 N 20181231 49738-490_64649f07-d48d-4ae5-92bc-be3b47b9587c 49738-490 HUMAN OTC DRUG Smart Sense naproxen sodium Naproxen Sodium TABLET ORAL 20100715 ANDA ANDA074661 Kmart Corporation NAPROXEN SODIUM 220 mg/1 N 20181231 49738-499_512ed2d6-bdbe-441d-883e-98fce4c729ba 49738-499 HUMAN OTC DRUG Smart Sense Pump Mist Oxymetazoline HCl SPRAY NASAL 20140128 OTC MONOGRAPH FINAL part341 Kmart Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 49738-500_d30d9563-e610-4900-a936-2ddb46e86725 49738-500 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130430 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) DOCUSATE SODIUM 100 mg/1 N 20181231 49738-504_59beddc5-bb8f-4ed1-8092-c6ba4f8bdb37 49738-504 HUMAN OTC DRUG Smart Sense Allergy Relief diphenhydramine HCl CAPSULE ORAL 20140210 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49738-507_2464c9b3-e8d3-4255-b904-94e1cdc990a8 49738-507 HUMAN OTC DRUG Smart Sense nighttime cold and flu acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl TABLET, FILM COATED ORAL 20150806 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49738-510_32a5f79e-9341-1944-e054-00144ff88e88 49738-510 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110430 ANDA ANDA091355 SMART SENSE (KMART) IBUPROFEN 200 mg/1 N 20181231 49738-511_8b361ba4-4722-4cf6-8e1b-5cba70e9ff21 49738-511 HUMAN OTC DRUG Smart Sense Antacid aluminum hydroxide, magnesium hydroxide, simethicone SUSPENSION ORAL 20150819 OTC MONOGRAPH FINAL part331 Kmart Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 49738-517_e140a0c0-981c-4d3e-9d20-d6a3e90014f5 49738-517 HUMAN OTC DRUG smart sense ibuprofen gluten free Ibuprofen TABLET, FILM COATED ORAL 20100618 ANDA ANDA077349 Kmart Corporation IBUPROFEN 200 mg/1 N 20181231 49738-519_8f8986b8-6010-4ffd-9134-d10223ee9618 49738-519 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 N 20181231 49738-522_6a926298-20b9-44b5-8cf6-2da54e3b745a 49738-522 HUMAN OTC DRUG smart sense cough and chest congestion Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20151002 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 49738-530_b2bed99f-5316-4f27-b76e-bbdc4a4608fd 49738-530 HUMAN OTC DRUG Oil-Free Acne Wash Salicylic Acid LOTION TOPICAL 20130801 OTC MONOGRAPH FINAL part333D Kmart Corporation SALICYLIC ACID 2 g/100mL N 20181231 49738-541_7887ac4e-ecdf-4750-aa57-da38581c214d 49738-541 HUMAN OTC DRUG anti itch maximum strength Hydrocortisone CREAM TOPICAL 20101223 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g N 20181231 49738-544_c82f2a27-a1d8-4f4f-97c3-077594a2715e 49738-544 HUMAN OTC DRUG Smart Sense arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100909 ANDA ANDA075077 Kmart Corporation ACETAMINOPHEN 650 mg/1 N 20181231 49738-548_97e67a88-968e-41b3-b4a7-9fb342479de0 49738-548 HUMAN OTC DRUG Smart Sense daytime cold and flu acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20150813 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49738-551_1a69506b-a1e5-4f3a-b75a-6e6e7fa21fcf 49738-551 HUMAN OTC DRUG SMART SENSE ICEBERG BLUE EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20150817 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-551_7a1fcc3f-44e8-4901-8cbe-0c512fcde547 49738-551 HUMAN OTC DRUG Smart sense Iceberg Blue Eucalyptol, Menthol, Methyl Salicylate, Thymol LIQUID ORAL 20130422 OTC MONOGRAPH NOT FINAL part356 Kmart Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-552_1c7cb46c-2865-4290-adc4-5a5df3f104c1 49738-552 HUMAN OTC DRUG SMART SENSE ANTICAVITY SODIUM FLUORIDE LIQUID ORAL 20130509 OTC MONOGRAPH FINAL part355 KMART CORPORATION SODIUM FLUORIDE .2 mg/mL N 20181231 49738-553_cc7d57bf-7b5e-4ad3-8481-40be811f0935 49738-553 HUMAN OTC DRUG SMART SENSE ALCOHOL FREE CETYLPYRIDINIUM CHLORIDE LIQUID ORAL 20130509 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 49738-554_e99e0f9f-b4b8-478f-a21c-79cd724c02af 49738-554 HUMAN OTC DRUG SMART SENSE ALCOHOL FREE SODIUM FLUORIDE LIQUID ORAL 20130509 OTC MONOGRAPH FINAL part355 KMART CORPORATION SODIUM FLUORIDE .5 mg/mL N 20181231 49738-555_72219800-a4dd-4dc7-a0ad-9ce266237e39 49738-555 HUMAN OTC DRUG SMART SENSE CITRUS EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL LIQUID ORAL 20130509 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .06; .064 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-555_84916c58-5f36-466f-ba09-08ae808c8258 49738-555 HUMAN OTC DRUG SMART SENSE CITRUS EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .06; .064 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-555_8bbbce03-a811-4a3a-9a5c-5b72816ef95e 49738-555 HUMAN OTC DRUG SMART SENSE CITRUS EUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOL LIQUID ORAL 20160210 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .06; .064 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-556_1ccbd9e6-213f-42fc-a26b-4c0fa4e248d9 49738-556 HUMAN OTC DRUG Smart Sense Original Flavor eucalyptol, Menthol, Methyl Salicylate, Thymol LIQUID ORAL 20170329 OTC MONOGRAPH NOT FINAL part356 Kmart Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-556_7ccbff24-3c70-4df1-89fd-1a66895f36af 49738-556 HUMAN OTC DRUG SMART SENSE ORIGINAL FLAVOR EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-556_a84f1f11-bc04-40e6-ab6d-d86b5c06939b 49738-556 HUMAN OTC DRUG SMART SENSE ORIGINAL FLAVOR EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20160210 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-556_d82e7e36-82f7-4ccb-ad87-a887474c473b 49738-556 HUMAN OTC DRUG SMART SENSE ORIGINAL FLAVOR EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-557_5703294a-2f10-483d-a019-a05df9f4706f 49738-557 HUMAN OTC DRUG SMART SENSE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20151126 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-557_79bc9379-7814-481c-940a-598d1eec2cab 49738-557 HUMAN OTC DRUG SMART SENSE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-557_7b3b8e8a-91d2-48fd-9510-2f08d6667ed2 49738-557 HUMAN OTC DRUG SMART SENSE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20160210 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-557_c10cb010-2ccf-4d81-a5cc-814fcb590447 49738-557 HUMAN OTC DRUG SMART SENSE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-557_c7eb62aa-b110-4129-8e68-59b8a0f3b7c4 49738-557 HUMAN OTC DRUG SMART SENSE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140319 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-557_da935006-0cfb-40a0-9e6b-f75683b9c34e 49738-557 HUMAN OTC DRUG SMART SENSE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-558_0e11677f-c35b-4bf9-9cb4-e063fb469d47 49738-558 HUMAN OTC DRUG SMART SENSE SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-558_29e36ace-4baa-4619-835b-36967d7ebb1a 49738-558 HUMAN OTC DRUG SMART SENSE SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20160210 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-558_34fdf76b-ff8f-40e5-b373-969015022e90 49738-558 HUMAN OTC DRUG SMART SENSE SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140319 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-558_949dd636-d8ba-4a5b-ae1e-3ccec300cd7b 49738-558 HUMAN OTC DRUG SMART SENSE SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130513 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-558_c0039f0d-480d-466d-9c92-819035b077bf 49738-558 HUMAN OTC DRUG SMART SENSE SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20160308 OTC MONOGRAPH NOT FINAL part356 KMART CORPORATION EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49738-563_6bfd2de7-28be-4889-9ea4-36749469bc39 49738-563 HUMAN OTC DRUG smart sense sinus and headache Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20170405 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 49738-567_398805b0-ab12-4696-b559-42d9ef788dd5 49738-567 HUMAN OTC DRUG smart sense daytime nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130415 OTC MONOGRAPH FINAL part341 Kmart Corporation N 20181231 49738-571_2605c902-fa49-4808-ad0d-aee324cf0d57 49738-571 HUMAN OTC DRUG smart sense allergy relief fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110623 ANDA ANDA076447 Kmart Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 49738-584_929de813-61a9-4980-8447-32e1fe4255e0 49738-584 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20171001 OTC MONOGRAPH NOT FINAL part334 SMART SENSE (Kmart) DOCUSATE SODIUM 100 mg/1 N 20181231 49738-588_d8063a7a-7ef7-4c27-aca2-87c66313333a 49738-588 HUMAN OTC DRUG Smart Sense Hydrocortisone Hydrocortisone CREAM TOPICAL 20140227 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g N 20181231 49738-599_63790f1f-8fac-4c46-b734-867c80d308b4 49738-599 HUMAN OTC DRUG Image Essentials Miconazole Treatment Miconazole nitrate KIT 20150204 ANDA ANDA076357 Kmart Corporation N 20181231 49738-600_9ceb8c88-c221-44c7-ae1c-9f1f43be1c21 49738-600 HUMAN OTC DRUG smart sense allergy relief Cetirizine Hydrochloride TABLET ORAL 20140418 ANDA ANDA078336 Kmart Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 49738-603_2218fefb-64c9-4c1a-a5bf-c391f592e6e1 49738-603 HUMAN OTC DRUG Smart Sense DayTime acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20131206 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 49738-604_6d1806c5-fbc6-43ae-8126-13e256f89719 49738-604 HUMAN OTC DRUG smart sense ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20100604 ANDA ANDA072096 Kmart Corporation IBUPROFEN 200 mg/1 N 20181231 49738-612_9b370a5b-4cec-4d64-a3d7-7e6848a243b8 49738-612 HUMAN OTC DRUG Smart Sense Allergy Relief non drowsy Loratadine TABLET ORAL 20101124 ANDA ANDA076301 Kmart Corporation LORATADINE 10 mg/1 N 20181231 49738-617_90247c36-86bb-49c4-ac62-a63a62d01000 49738-617 HUMAN OTC DRUG Smart Sense Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Kmart Corporation SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 49738-619_0905203c-804b-4756-8272-d955cef5c299 49738-619 HUMAN OTC DRUG Acid Reducer Regular Strength Ranitidine TABLET, FILM COATED ORAL 20130615 20180715 ANDA ANDA200536 Kmart Corporation RANITIDINE HYDROCHLORIDE 75 mg/1 E 20171231 49738-620_44aaccba-0350-63dc-e054-00144ff8d46c 49738-620 HUMAN OTC DRUG Smart Sense Hydrogen Peroxide Solution Hydrogen Peroxide SPRAY TOPICAL 20150410 OTC MONOGRAPH NOT FINAL part333A Kmart Corporation HYDROGEN PEROXIDE 3 mL/100mL N 20181231 49738-621_44aaccba-0360-63dc-e054-00144ff8d46c 49738-621 HUMAN OTC DRUG Smart Sense 70% Isopropyl Rubbing Alcohol First Aid Antiseptic Isopropyl alcohol LIQUID TOPICAL 20150410 OTC MONOGRAPH NOT FINAL part333A Kmart Corporation ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 49738-626_08db02c3-c4af-40ff-8d39-1e8e943ce9e1 49738-626 HUMAN OTC DRUG Daily Moisturizing Broad Spectrum SPF15 Sunscreen Avobenzone, Homosalate, Octinoxate, Octocrylene LOTION TOPICAL 20131110 OTC MONOGRAPH NOT FINAL part352 Kmart Corporation AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 3; 5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 49738-629_406b0dca-0e67-3ce1-e054-00144ff8d46c 49738-629 HUMAN OTC DRUG cherry cough drop menthol LOZENGE ORAL 20150811 OTC MONOGRAPH FINAL part341 Kmart MENTHOL 5.8 mg/1 N 20181231 49738-630_388e2bd6-3126-4de8-e054-00144ff88e88 49738-630 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20150811 OTC MONOGRAPH FINAL part341 Kmart Corporation MENTHOL 5.4 mg/1 N 20181231 49738-631_38a2a1d5-a70f-1f7b-e054-00144ff8d46c 49738-631 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20150811 OTC MONOGRAPH FINAL part341 Kmart Corporation MENTHOL 5.8 mg/1 N 20181231 49738-632_38a52b40-92b8-63ab-e054-00144ff88e88 49738-632 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20150811 OTC MONOGRAPH FINAL part341 Kmart Corporation MENTHOL 7.5 mg/1 N 20181231 49738-632_4069cf32-8bb7-572e-e054-00144ff8d46c 49738-632 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20150811 OTC MONOGRAPH FINAL part341 Kmart MENTHOL 7.5 mg/1 N 20181231 49738-633_39d05ef7-be76-5823-e054-00144ff8d46c 49738-633 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20150811 OTC MONOGRAPH FINAL part341 Kmart Corporation MENTHOL 5.8 mg/1 N 20181231 49738-634_390615cc-3b2e-20ef-e054-00144ff88e88 49738-634 HUMAN OTC DRUG sugar free cherry cough drops menthol LOZENGE ORAL 20150811 OTC MONOGRAPH FINAL part341 Kmart Corporation MENTHOL 5.8 mg/1 N 20181231 49738-635_390976bc-7f5f-249a-e054-00144ff88e88 49738-635 HUMAN OTC DRUG sugar free honey lemon cough drops menthol LOZENGE ORAL 20150811 OTC MONOGRAPH FINAL part341 Kmart Corporation MENTHOL 7.6 mg/1 N 20181231 49738-636_39d18e69-a8f0-6774-e054-00144ff8d46c 49738-636 HUMAN OTC DRUG Sore Throat and Cough Lozenge Benzocaine LOZENGE ORAL 20150811 OTC MONOGRAPH NOT FINAL part356 Kmart Corporation BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20181231 49738-637_bdec1da3-39af-412f-ab15-8fa0740e7be0 49738-637 HUMAN OTC DRUG smart sense miconazole 7 Miconazole nitrate CREAM VAGINAL 20160624 ANDA ANDA074760 Kmart Corporation MICONAZOLE NITRATE 2 g/100g N 20181231 49738-639_c7942a74-afae-489b-9313-1065c6fe099a 49738-639 HUMAN OTC DRUG Smart Sense Miconazole 3 Miconazole nitrate KIT 20160818 ANDA ANDA075329 Kmart Corporation N 20181231 49738-645_bfc6c14c-4c45-4095-ba9d-0f2ecb241d36 49738-645 HUMAN OTC DRUG smart sense loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120514 ANDA ANDA091292 Kmart Corporation LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 49738-647_d7fcd367-dd0a-4686-a2b3-3918ef68a586 49738-647 HUMAN OTC DRUG smart sense ibuprofen Ibuprofen TABLET, COATED ORAL 20100617 ANDA ANDA072096 Kmart Corporation IBUPROFEN 200 mg/1 N 20181231 49738-655_c0f46b78-9605-4251-ad62-a1203f5a898c 49738-655 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 49738-656_6bc7b775-2cce-41a1-b6d3-35991eb93b40 49738-656 HUMAN OTC DRUG smart sense daytime acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20110201 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 49738-668_8d9d3e68-bc39-4201-8589-a2ea337ddac9 49738-668 HUMAN OTC DRUG smart sense nighttime cough Dextromethorphan Hydrobromide, Doxylamine Succinate SOLUTION ORAL 20101203 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 49738-679_5d77b701-f252-42d0-a483-4f5fa4d8a324 49738-679 HUMAN OTC DRUG smart sense triple antibiotic Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20101106 OTC MONOGRAPH FINAL part333B Kmart Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 49738-685_3df74276-f204-4369-b144-93e513a64e78 49738-685 HUMAN OTC DRUG Smart Sense ibuprofen Ibuprofen SUSPENSION ORAL 20100520 ANDA ANDA074937 Kmart Corporation IBUPROFEN 100 mg/5mL N 20181231 49738-686_918faf0a-196f-4ccf-a577-fc2c8793de99 49738-686 HUMAN OTC DRUG LORATADINE LORATADINE CAPSULE, LIQUID FILLED ORAL 20170131 ANDA ANDA206214 SMART SENSE (KMART) LORATADINE 10 mg/1 N 20181231 49738-692_de703c9a-1af3-436e-8ef6-def436fe83f4 49738-692 HUMAN OTC DRUG smart sense cool heat Menthol, Methyl salicylate CREAM TOPICAL 20110724 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 49738-694_c9a2cae8-3eb1-473a-850b-68472524347d 49738-694 HUMAN OTC DRUG Anti-Aging Vitamin Complex 7-in-1 Broad Spectrum SPF15 Sunscreen Avobenzone, Octisalate, Octocrylene LOTION TOPICAL 20131110 OTC MONOGRAPH NOT FINAL part352 Kmart Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 g/100mL; g/100mL; g/100mL N 20181231 49738-695_22236ca1-49d3-4a8e-855c-f7847e145a44 49738-695 HUMAN OTC DRUG smart sense Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20140220 OTC MONOGRAPH FINAL part341 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49738-700_30b73cf9-a06c-436d-bcea-a4c89ff72ddc 49738-700 HUMAN OTC DRUG smart sense anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20110109 ANDA ANDA075232 Kmart Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 49738-702_feafc7dd-d41a-451e-969b-54b309b5b072 49738-702 HUMAN OTC DRUG Smart Sense Topical Analgesic Skin Protectant Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20131213 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 49738-705_4fdb432f-ba73-4c50-80e1-6db3f11c3f7e 49738-705 HUMAN OTC DRUG Smart Sense Cough and chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20160606 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 49738-707_9b5dcae1-3c58-4c83-8ad6-73a3e332ca1a 49738-707 HUMAN OTC DRUG Smart sense Hydrocortisone hydrocortisone OINTMENT TOPICAL 20150708 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g N 20181231 49738-709_0702d99a-6bf2-44c0-8b5a-9ea2809a65ba 49738-709 HUMAN OTC DRUG smart sense allergy relief d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20150810 ANDA ANDA077170 Kmart Corporation CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 49738-711_91168e94-8281-42de-bfc8-84028a5b72de 49738-711 HUMAN OTC DRUG Smart Sense sinus plus headache Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate KIT 20170605 OTC MONOGRAPH FINAL part341 Kmart Corporation N 20181231 49738-713_70aed9bd-6863-401b-a054-2423bd14ac4a 49738-713 HUMAN OTC DRUG Smart Sense Miconazole 3 Miconazole nitrate KIT 20160629 ANDA ANDA076357 Kmart Corporation N 20181231 49738-715_bbf88e3f-8c8f-4465-87c3-5022288e446e 49738-715 HUMAN OTC DRUG Kmart Corporation Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Kmart Corporation SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 49738-720_f0da44e2-affd-4e9b-99e6-0c6c3d0444df 49738-720 HUMAN OTC DRUG IMAGE ESSENTIALS Antibacterial TRICLOSAN SOAP TOPICAL 20101109 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .115 mL/100mL N 20181231 49738-721_fa936a1a-6158-42de-8201-0814f33366c1 49738-721 HUMAN OTC DRUG IMAGE ESSENTIALS TRICLOSAN LIQUID TOPICAL 20120221 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN .115 mL/100mL N 20181231 49738-722_6b1a5c79-8629-491a-bf0f-e9e7b1a7d738 49738-722 HUMAN OTC DRUG IMAGE ESSENTIALS ANTIBACTERIAL HAND GOLD TRICLOSAN LIQUID TOPICAL 20141117 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 1.5 mg/mL N 20181231 49738-723_678282d8-1ba3-4447-b87d-2caf2978f632 49738-723 HUMAN OTC DRUG IMAGE ESSENTIALS ANTIBACTERIAL HAND GOLD TRICLOSAN LIQUID TOPICAL 20141117 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 1.5 mg/mL N 20181231 49738-723_8b60047f-d36d-496c-b266-8f731a565e45 49738-723 HUMAN OTC DRUG IMAGE ESSENTIALS ANTIBACTERIAL HAND GOLD TRICLOSAN LIQUID TOPICAL 20140826 OTC MONOGRAPH NOT FINAL part333E KMART CORPORATION TRICLOSAN 1.5 mg/mL N 20181231 49738-731_3ebef41a-c050-4b0e-bd1b-de9e7ad210fe 49738-731 HUMAN OTC DRUG Image Essentials Gold Triclocarban SOAP TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333A Kmart Corporation TRICLOCARBAN .3 g/100g E 20171231 49738-733_af10bfae-1f14-4557-9965-c071349a7373 49738-733 HUMAN OTC DRUG Smart Sense NightTime DayTime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130823 OTC MONOGRAPH FINAL part341 Kmart Corporation N 20181231 49738-737_a85cadbf-719a-4dab-a01d-74bb98e09902 49738-737 HUMAN OTC DRUG smart sense miconazole 1 Miconazole nitrate KIT 20100615 ANDA ANDA079114 Kmart Corporation N 20181231 49738-746_4307e83a-65a1-4084-ac98-ae31f820140f 49738-746 HUMAN OTC DRUG Image Essentials Daily Illuminating Moisturizer Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 KMART Corporation AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 g/100g; g/100g; g/100g N 20181231 49738-758_9c752c32-7e1c-47ad-a01a-1e7dde8f0c7d 49738-758 HUMAN OTC DRUG Smart Sense Infants Pain Relief Acetaminophen SUSPENSION ORAL 20131217 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 160 mg/5mL N 20181231 49738-763_1123e4b0-c623-4db4-98c8-72f303b1d4e4 49738-763 HUMAN OTC DRUG Smart Sense Severe Cold and Flu NightTime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20131122 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 49738-771_c88822bb-087b-4318-bcfa-83d6bdc7839f 49738-771 HUMAN OTC DRUG Smart Sense Enamel Guard Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Kmart Corporation SODIUM FLUORIDE; POTASSIUM NITRATE 1.5; 5 g/g; g/g N 20181231 49738-779_32a5f79e-931e-1944-e054-00144ff88e88 49738-779 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen TABLET ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 SMART SENSE (KMART) ACETAMINOPHEN 325 mg/1 N 20181231 49738-780_32a66e5e-9f60-231f-e054-00144ff8d46c 49738-780 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20131014 OTC MONOGRAPH NOT FINAL part343 SMART SENSE (KMART) ACETAMINOPHEN 500 mg/1 N 20181231 49738-781_32a5f79e-9380-1944-e054-00144ff88e88 49738-781 HUMAN OTC DRUG ASPIRIN Regular Strength ASPIRIN TABLET, COATED ORAL 20110430 OTC MONOGRAPH NOT FINAL part343 SMART SENSE (KMART) ASPIRIN 325 mg/1 N 20181231 49738-782_32a5f79e-9331-1944-e054-00144ff88e88 49738-782 HUMAN OTC DRUG Complete Allergy Relief 4-Hour CHLORPHENIRAMINE MALEATE TABLET, COATED ORAL 20150630 OTC MONOGRAPH FINAL part341 SMART SENSE (KMART) CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 49738-783_32a66e5e-9f8a-231f-e054-00144ff8d46c 49738-783 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20120331 OTC MONOGRAPH FINAL part341 Smart Sense (KMART) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 49738-784_32a66e5e-9f9f-231f-e054-00144ff8d46c 49738-784 HUMAN OTC DRUG CHEWABLE ASPIRIN LOW DOSE ASPIRIN TABLET, CHEWABLE ORAL 20110630 OTC MONOGRAPH NOT FINAL part343 SMART SENSE (KMART) ASPIRIN 81 mg/1 N 20181231 49738-785_32a5f79e-9356-1944-e054-00144ff88e88 49738-785 HUMAN OTC DRUG DAYTIME MULTI-SYMPTOM COLD RELIEF ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20150930 OTC MONOGRAPH FINAL part341 SMART SENSE (KMART) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 49738-786_32a5f79e-936c-1944-e054-00144ff88e88 49738-786 HUMAN OTC DRUG Low Dose Aspirin Low Dose ASPIRIN TABLET, DELAYED RELEASE ORAL 20110630 OTC MONOGRAPH NOT FINAL part343 SMART SENSE (KMART) ASPIRIN 81 mg/1 N 20181231 49738-787_32a66e5e-9fb8-231f-e054-00144ff8d46c 49738-787 HUMAN OTC DRUG Severe Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20150930 OTC MONOGRAPH FINAL part341 SMART SENSE (KMART) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49738-788_32a6f15c-d822-5566-e054-00144ff8d46c 49738-788 HUMAN OTC DRUG PRESSURE plus PAIN plus MUCUS ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20150630 OTC MONOGRAPH FINAL part341 SMART SENSE (KMART) ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 49738-789_32a6d3d3-3a2f-3fdd-e054-00144ff8d46c 49738-789 HUMAN OTC DRUG SEVERE COLD HEAD CONGESTION ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20151031 OTC MONOGRAPH FINAL part341 SMART SENSE (KMART) ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 49738-798_02f7e7af-2879-4f27-b91a-f9f7e5514c5c 49738-798 HUMAN OTC DRUG Image Essentials Hair Regrowth Treatment Minoxidil SOLUTION TOPICAL 20110712 ANDA ANDA075598 Kmart Corporation MINOXIDIL 3 g/60mL N 20181231 49738-801_454305d0-2701-4ecd-ad32-95749f74dd48 49738-801 HUMAN OTC DRUG K-Mart SmartSense First Aid Contains 101 Pieces BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100511 OTC MONOGRAPH FINAL part333 K Mart N 20181231 49738-802_075459e9-2adb-44b5-a8c6-99c05ff35a08 49738-802 HUMAN OTC DRUG K-Mart SmartSense First Aid Contains 303 Pieces BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOTROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100511 OTC MONOGRAPH FINAL part333 Kmart Corporation N 20181231 49738-805_b998c975-d779-4e2c-880a-472226215595 49738-805 HUMAN OTC DRUG Antibacterial Body Wash Triclosan LIQUID TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E Kmart Corporation TRICLOSAN .15 mL/100mL N 20181231 49738-811_9687ed77-5357-4f0e-b341-03636a58d593 49738-811 HUMAN OTC DRUG KMart Corporation Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20140224 OTC MONOGRAPH FINAL part355 KMart Corporation SODIUM FLUORIDE .243 g/100g N 20181231 49738-812_f6bb3c7a-442c-491a-9f63-be90315f38d5 49738-812 HUMAN OTC DRUG KMart Corporation Prisim White Fluoride PASTE, DENTIFRICE DENTAL 20140224 OTC MONOGRAPH FINAL part355 KMart Corporation SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 49738-813_8ff6161e-e9fc-4a7d-a232-5b2d6a9bdd34 49738-813 HUMAN OTC DRUG smart sense sinus relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20151229 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 49738-823_d8a123d8-9065-4c9d-8bf2-558e4160eefb 49738-823 HUMAN OTC DRUG Smart Sense Miconazole 1 Miconazole nitrate KIT 20160818 ANDA ANDA079114 Kmart Corporation N 20181231 49738-825_8652a0dc-f4be-463a-87c3-7c9e24ad8685 49738-825 HUMAN OTC DRUG smart sense 7 day treatment Miconazole nitrate CREAM VAGINAL 20110210 ANDA ANDA074760 Kmart Corporation MICONAZOLE NITRATE 2 g/100g N 20181231 49738-857_b3361486-d068-44e1-aeb2-482c5ebfa5e2 49738-857 HUMAN OTC DRUG smart sense athletes foot antifungal Clotrimazole CREAM TOPICAL 20101119 OTC MONOGRAPH FINAL part333C Kmart Corporation CLOTRIMAZOLE 1 g/100g N 20181231 49738-866_5c678b29-7440-4f7b-ad15-1033addc71d8 49738-866 HUMAN OTC DRUG smart sense lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20110627 OTC MONOGRAPH FINAL part358G Kmart Corporation PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 49738-886_2f7d1901-e33a-4764-af7f-e1a340127763 49738-886 HUMAN OTC DRUG smart sense sinus congestion and pain day night Acetaminophen,Phenylephrine HCl, Chlorpheniramine maleate KIT 20111116 OTC MONOGRAPH FINAL part341 Kmart Corporation N 20181231 49738-886_d1d56170-80f0-4e7c-9106-001263dff3cb 49738-886 HUMAN OTC DRUG smart sense sinus Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20110310 OTC MONOGRAPH FINAL part341 Kmart Corporation N 20181231 49738-888_387a6587-7ddd-479b-9f22-64ffee525795 49738-888 HUMAN OTC DRUG Smart Sense Zinc Cold Remedy Zincum Aceticum, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20140228 UNAPPROVED HOMEOPATHIC Kmart Corporation ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 49738-897_6e5a614e-5f3d-4fbf-8764-fea0c77b608c 49738-897 HUMAN OTC DRUG smart sense ibuprofen Ibuprofen SUSPENSION ORAL 20100520 ANDA ANDA074937 Kmart Corporation IBUPROFEN 100 mg/5mL N 20191231 49738-898_7e899a44-cade-42e7-bfa4-c5cf87f96f17 49738-898 HUMAN OTC DRUG smart sense esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20171002 ANDA ANDA207193 Kmart Corporation ESOMEPRAZOLE 20 mg/1 N 20181231 49738-906_14857827-0b79-4be8-a9ff-6331be58a0eb 49738-906 HUMAN OTC DRUG smart sense cold and allergy childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20110331 OTC MONOGRAPH FINAL part341 Kmart Corporation PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 49738-911_f7aa38e9-c590-43cc-b335-10e366736b98 49738-911 HUMAN OTC DRUG Smart Sense pump mist Oxymetazoline hydrochloride SPRAY NASAL 20170530 OTC MONOGRAPH FINAL part341 Kmart Corporation OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 49738-915_545672b3-7927-4da2-9ad6-19f5aeeebb3d 49738-915 HUMAN OTC DRUG smart sense omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20110120 NDA NDA022032 Kmart Corporation OMEPRAZOLE 20 mg/1 N 20181231 49738-922_edf45752-286d-4009-857f-b4b69389fd95 49738-922 HUMAN OTC DRUG Smart Sense Severe Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20151111 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49738-927_bb0f601b-4a5e-4ab5-8255-4a3f3e25ebc3 49738-927 HUMAN OTC DRUG Maximum Strength Original Diaper Rash Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 KMART Corporation ZINC OXIDE 400 mg/g N 20181231 49738-936_4e472e39-a5ea-4e65-bcb9-6cc6ecf0b232 49738-936 HUMAN OTC DRUG smart sense sinus relief Acetaminophen, guaifenesin, diphenhydramine HCl, phenylephrine HCl KIT 20151229 OTC MONOGRAPH FINAL part341 Kmart Corporation N 20181231 49738-945_4236ae39-41d8-44a4-8efd-654e333c43b6 49738-945 HUMAN OTC DRUG Little Ones Petroleum Petrolatum JELLY TOPICAL 20121022 OTC MONOGRAPH FINAL part347 Kmart Corporation PETROLATUM 100 g/100g E 20171231 49738-958_a47e4af0-5d33-4508-856f-d2b40e71759f 49738-958 HUMAN OTC DRUG Smart Sense Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130805 ANDA ANDA091135 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 49738-960_78b3fbc0-98f5-47aa-b5f5-f21082bb2232 49738-960 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide LIQUID ORAL 20160128 OTC MONOGRAPH NOT FINAL part334 Kmart Corporation MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 49738-966_e8e9f2d4-9b58-4896-b575-0463a18ce266 49738-966 HUMAN OTC DRUG smart sense arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101014 ANDA ANDA075077 Kmart Corporation ACETAMINOPHEN 650 mg/1 N 20181231 49738-970_c2f4ec17-c56f-4dc6-9be5-f71760a34383 49738-970 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130401 OTC MONOGRAPH FINAL part336 SMART SENSE (Kmart) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49738-973_d69e6063-8ce3-4816-b0ea-27fb1b112a90 49738-973 HUMAN OTC DRUG smart sense anti itch hydrocortisone CREAM TOPICAL 20100927 OTC MONOGRAPH NOT FINAL part348 Kmart Corporation HYDROCORTISONE 1 g/100g N 20181231 49738-975_19cf2bd1-6fde-44cf-8ee1-b7b624ee7f63 49738-975 HUMAN OTC DRUG smart sense pain relief Acetaminophen TABLET ORAL 20100722 OTC MONOGRAPH NOT FINAL part343 Kmart Corporation ACETAMINOPHEN 500 mg/1 N 20181231 49738-982_e41d1c88-489a-47b2-be54-ec0a3dccc78d 49738-982 HUMAN OTC DRUG smart sense 3 day treatment vaginal antifungal Miconazole nitrate KIT 20110516 ANDA ANDA076357 Kmart Corporation N 20181231 49738-987_c3173dd1-9bf2-4e25-abe4-2d67a80a8195 49738-987 HUMAN OTC DRUG smart sense cold and cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20101229 OTC MONOGRAPH FINAL part341 Kmart Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 49738-994_6c604f5c-0a25-407a-a543-082f9be261d7 49738-994 HUMAN OTC DRUG Little Ones Maximum Strength ZINC OXIDE CREAM TOPICAL 20150312 OTC MONOGRAPH FINAL part347 Kmart Corporation ZINC OXIDE 40 g/100g N 20181231 49738-995_ae2070c3-e318-42e0-8239-4e3781001a5c 49738-995 HUMAN OTC DRUG KMart - Fast Maximum Cold, Flu and Sore Throat Relief Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20150811 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 49738-996_a76bcd58-6930-477d-bfde-981fcb70fdd0 49738-996 HUMAN OTC DRUG KMart - Fast Maximum Cold and Sinus Acetaminophen, Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20150811 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 49738-997_023422db-fc33-4a07-9a37-bcc3e47d3be9 49738-997 HUMAN OTC DRUG KMart - Fast Maximum Severe Congestion and Cough Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20150730 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 49738-998_8c31ce45-b91b-4d75-a1d3-4266a16f6a89 49738-998 HUMAN OTC DRUG KMart - Fast Maximum DM MAX Dextromethorphan Hydrobromide and Guaifenesin SOLUTION ORAL 20150730 OTC MONOGRAPH FINAL part341 Kmart Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 49738-999_b55b98d0-99bb-4432-9863-8325964303f5 49738-999 HUMAN OTC DRUG KMart - Pain Relief PM Acetaminophen and Diphenhydramine HCl SOLUTION ORAL 20150817 OTC MONOGRAPH FINAL part341 Kmart Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/15mL; mg/15mL N 20181231 49741-1005_5e6e713c-9d13-8392-e053-2991aa0a7f9e 49741-1005 HUMAN OTC DRUG MedActive Patient Friendly Stannous Fluoride KIT ORAL 20140731 OTC MONOGRAPH FINAL part355 Integrate Oral Care, LLC. N 20181231 49741-1006_5e6e9c4e-c3d5-46ad-e053-2a91aa0ac9e4 49741-1006 HUMAN OTC DRUG MedActive Patient Friendly Stannous Fluoride Rinse Stannous Fluoride KIT ORAL 20140731 OTC MONOGRAPH FINAL part355 Integrate Oral Care, LLC. N 20181231 49741-1007_5e6df46c-2528-06b4-e053-2a91aa0a7064 49741-1007 HUMAN OTC DRUG MedActive Patient Friendly Stannous Fluoride KIT ORAL 20140731 OTC MONOGRAPH FINAL part355 Integrate Oral Care, LLC. N 20181231 49741-1009_5e989afa-f21c-8639-e053-2991aa0a3ac7 49741-1009 HUMAN OTC DRUG MedActive Oral Relief Lozenge LOZENGE ORAL 20150831 OTC MONOGRAPH NOT FINAL part356 Integrate Oral Care, LLC. PECTIN 2.8 mg/1 N 20181231 49741-1010_616b75c9-63fa-1731-e053-2991aa0a3ff5 49741-1010 HUMAN OTC DRUG MedActive Oral Relief Lozenge LOZENGE ORAL 20150831 OTC MONOGRAPH NOT FINAL part356 Integrate Oral Care, LLC. PECTIN 2.8 mg/1 N 20181231 49741-1011_616b4399-762a-5e59-e053-2a91aa0a0f75 49741-1011 HUMAN OTC DRUG MedActive Oral Relief Lozenge LOZENGE ORAL 20150831 OTC MONOGRAPH NOT FINAL part356 Integrate Oral Care, LLC. PECTIN 2.8 mg/1 N 20181231 49741-1012_616b84b8-58b0-2e24-e053-2a91aa0ac110 49741-1012 HUMAN OTC DRUG MedActive Oral Relief Lozenge LOZENGE ORAL 20150831 OTC MONOGRAPH NOT FINAL part356 Integrate Oral Care, LLC. PECTIN 2.8 mg/1 N 20181231 49741-1016_5e97d32a-901d-35fe-e053-2a91aa0aea9f 49741-1016 HUMAN OTC DRUG MedActive Oral Relief Spray SPRAY ORAL 20150831 OTC MONOGRAPH NOT FINAL part356 Integrate Oral Care, LLC. GLYCERIN 29.5 mg/mL N 20181231 49741-1019_5e9886a3-0d47-15e6-e053-2a91aa0a1586 49741-1019 HUMAN OTC DRUG MedActive Oral Relief Spray SPRAY ORAL 20150831 OTC MONOGRAPH NOT FINAL part356 Integrate Oral Care, LLC. GLYCERIN 29.5 mg/mL N 20181231 49742-1001_8089b888-7b55-44ea-a12a-6ab827edf4e8 49742-1001 HUMAN OTC DRUG Skin-ion ARBUTIN, ADENOSINE, GLYCERIN SPRAY TOPICAL 20100101 OTC MONOGRAPH FINAL part347 WAKO Korea Corp ARBUTIN; ADENOSINE; GLYCERIN .8; .016; .8 mL/40mL; mL/40mL; mL/40mL E 20171231 49743-3001_7da063a7-3c4f-4626-b1c9-70bfd6488314 49743-3001 HUMAN OTC DRUG SelectHealth Tussin DM Guaifenesin LIQUID ORAL 20110901 OTC MONOGRAPH FINAL part341 Axcentria Pharmaceuticals, LLC. GUAIFENESIN 100 mg/5mL E 20171231 49743-3003_dfcebe7c-7215-47cf-9e2c-9822439eb207 49743-3003 HUMAN OTC DRUG Select Health Allergy Relief Cherry Diphenhydramine Hydrochloride LIQUID ORAL 20110901 OTC MONOGRAPH FINAL part341 Axcentria Pharmaceuticals, LLC. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 49743-3047_d763cf0b-a67f-490c-852d-ce795fa6e62f 49743-3047 HUMAN OTC DRUG Mineral Oil, Petrolatum and Phenylephrine HCl mineral oil, petrolatum, phenylephrine HCl OINTMENT TOPICAL 20130628 OTC MONOGRAPH FINAL part346 Axcentria Pharmaceuticals, LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 741; 2.5 mg/g; mg/g; mg/g E 20171231 49744-0001_564ecb41-7fcc-4041-9da6-fd51e3b64c6b 49744-0001 HUMAN OTC DRUG Herplex Anatherum Muricatum, Clematis Erecta, Mezereum, Phytolacca Decandra, Ranunculus Bulbosus, Thus Tox, Thuja Occidentalis, Natrum Muriaticum, Sepia TABLET ORAL 20140722 UNAPPROVED HOMEOPATHIC Paradigm, Inc. CHRYSOPOGON ZIZANIOIDES ROOT; CLEMATIS RECTA FLOWERING TOP; DAPHNE MEZEREUM BARK; PHYTOLACCA AMERICANA ROOT; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG; SODIUM CHLORIDE; SEPIA OFFICINALIS JUICE 12; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 49758-100_15cd1ba5-1174-4a5f-aeea-a5c7c59d0592 49758-100 HUMAN OTC DRUG Dermabon Psoriasis and Dandruff Soap COAL TAR SOAP TOPICAL 20091001 OTC MONOGRAPH FINAL part358 Jose Maria Licona Saenz COAL TAR 2.13 g/100g E 20171231 49762-450_41cd1174-13f5-4a50-8955-9f1cf9fc398e 49762-450 HUMAN OTC DRUG Earwax Removal Earwax Removal LIQUID AURICULAR (OTIC) 20080831 OTC MONOGRAPH FINAL part344 Apothecary Products, LLC CARBAMIDE PEROXIDE 6.5 mg/100mL E 20171231 49762-453_391897b2-7553-4c30-b756-9ac7e7b18e27 49762-453 HUMAN OTC DRUG Earwax Removal Aid Earwax Removal Aid LIQUID AURICULAR (OTIC) 20100831 OTC MONOGRAPH FINAL part344 Apothecary Products, LLC CARBAMIDE PEROXIDE 6.5 mg/100mL E 20171231 49765-310_d86f7aa6-1cb2-4c8d-829a-f3de5eb48c81 49765-310 HUMAN OTC DRUG ARTEMIS Alcohol-Free Antiseptic Foam Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110224 OTC MONOGRAPH FINAL part333E Artemis Bio-Solutions Inc BENZALKONIUM CHLORIDE .13 mL/100mL N 20181231 49765-410_5181a4d6-c9c0-4f4e-8662-b3193e5f28e6 49765-410 HUMAN OTC DRUG ARTEMIS Alcohol-Free Antiseptic Foam Hand BENZALKONIUM CHLORIDE SOAP TOPICAL 20110224 OTC MONOGRAPH FINAL part333E Artemis Bio-Solutions Inc BENZALKONIUM CHLORIDE .13 mL/100mL N 20181231 49766-2858_4e77ecca-c5c2-403d-a9d1-4e30ab1a6aca 49766-2858 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070225 UNAPPROVED MEDICAL GAS Max's Breathe Easy Gases & Supplies, Inc. OXYGEN 99 L/100L E 20171231 49771-002_fc25d647-a82a-4d47-bee7-19601ab73218 49771-002 HUMAN PRESCRIPTION DRUG Mitosol mitomycin KIT 20120208 NDA NDA022572 Mobius Therapeutics LLC N 20191231 49778-001_ff818ac6-b10e-4b24-b435-f2a75f290f89 49778-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090501 UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 992 mL/1000mL E 20171231 49778-002_11ca393a-47aa-4ee5-8d3b-61d818bdfe63 49778-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090501 UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 992 L/1000L E 20171231 49778-003_cb6fda01-23d6-4358-8bc8-37495c829949 49778-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20090501 UNAPPROVED MEDICAL GAS American Welding & Gas NITROGEN 99 mL/100mL E 20171231 49778-004_f4577f6b-6e29-4299-83e9-d02133ce44b8 49778-004 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20090501 UNAPPROVED MEDICAL GAS American Welding & Gas NITROGEN 99 L/100L E 20171231 49778-005_8f3fc95a-ae07-4d4e-b6e3-5309101a857b 49778-005 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090501 UNAPPROVED MEDICAL GAS American Welding & Gas OXYGEN 992 L/1000L E 20171231 49781-010_abc11406-1045-4f5d-b137-c5fa13c879ce 49781-010 HUMAN OTC DRUG leader childrens pain and fever Acetaminophen SUSPENSION ORAL 20100303 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL N 20181231 49781-011_8222e98b-3bd5-4802-97bf-52bfc24098fb 49781-011 HUMAN OTC DRUG Cold Head Congestion Nighttime Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20050721 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49781-012_ecc5e0ef-d46a-425f-a0f7-f996666c5a48 49781-012 HUMAN OTC DRUG LEADER Cough Drops Menthol Flavor MENTHOL LOZENGE ORAL 20131125 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 5.4 mg/1 N 20181231 49781-013_b2043aaf-5c61-4583-af25-3e4ef8f682af 49781-013 HUMAN OTC DRUG LEADER Cough Drops Cherry Flavor MENTHOL LOZENGE ORAL 20131125 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 5.8 mg/1 N 20181231 49781-014_f491ab2f-1245-439a-b50b-bb106fb8caa2 49781-014 HUMAN OTC DRUG LEADER Cough Drops Honey Lemon MENTHOL LOZENGE ORAL 20131125 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 7.5 mg/1 N 20181231 49781-015_308ba68d-86e8-43e3-a601-2e278250fe69 49781-015 HUMAN OTC DRUG leader childrens pain and fever Acetaminophen SUSPENSION ORAL 19900515 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL N 20181231 49781-016_5538ee62-aeee-4698-83cc-376bdc973e4d 49781-016 HUMAN OTC DRUG leader childrens pain and fever Acetaminophen SUSPENSION ORAL 19970622 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL N 20181231 49781-017_41930241-c72f-4c6b-a2d3-61ffb40b0f3e 49781-017 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20120301 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) 49781 DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 49781-018_0d456543-6b62-458d-a1cd-013f37f39b41 49781-018 HUMAN OTC DRUG Leader Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 19970512 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL N 20181231 49781-023_32893bd3-7ad0-4415-85ee-7a2da5b9cc4c 49781-023 HUMAN OTC DRUG Leader Childrens All Day Allergy Cetirizine HCl SOLUTION ORAL 20160203 ANDA ANDA204226 Cardinal Health CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 49781-025_5834d266-aa9b-4109-b08b-91cb9ae6bac9 49781-025 HUMAN OTC DRUG Leader Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 19900415 OTC MONOGRAPH FINAL part335 Cardinal Health BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 49781-026_4943c1d0-dd17-4785-99bd-bf3dd78461f0 49781-026 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130925 ANDA ANDA201745 Cardinal Health RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 49781-027_5fe5c89e-ca10-4981-9899-e42e2884628c 49781-027 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20130925 ANDA ANDA200536 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 49781-028_1c0d66c8-cb5e-42c8-8ff4-33043dd20bce 49781-028 HUMAN OTC DRUG leader lice treatment Permethrin LOTION TOPICAL 20110615 ANDA ANDA076090 Cardinal Health PERMETHRIN 1 mg/100mL N 20181231 49781-031_cccd18b5-6c61-48c3-b862-a386bf137df0 49781-031 HUMAN OTC DRUG Leader Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER Cardinal Health PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 49781-032_a83dc654-73f5-437c-9b0f-e0ff535d05d7 49781-032 HUMAN OTC DRUG Leader Lubricant Eye Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20140218 OTC MONOGRAPH FINAL part349 Cardinal Health CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL E 20171231 49781-034_d430ee2e-6036-4da4-8823-d84a4056aec0 49781-034 HUMAN OTC DRUG Leader Aller Ease fexofenadine hcl TABLET, FILM COATED ORAL 20140205 ANDA ANDA076447 Cardinal Health FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 49781-037_924de479-41f6-4ff6-b17c-d069edcc9d6f 49781-037 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) 49781 DOCUSATE SODIUM 100 mg/1 N 20181231 49781-038_3abd558c-9219-4d5a-bb6c-d1bd52dd5e9d 49781-038 HUMAN OTC DRUG Leader Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20131030 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49781-039_dca3b46f-3db4-4f13-8e68-b60c42edc6f9 49781-039 HUMAN OTC DRUG Leader Mucus Relief Cold and Sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20131030 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 49781-040_4b200473-6137-4af1-b9e1-2357c07caad9 49781-040 HUMAN OTC DRUG Leader Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20140123 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 49781-041_341dc604-9a56-448d-8e47-2ceb1d2f83ee 49781-041 HUMAN OTC DRUG Leader Original Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20130829 OTC MONOGRAPH FINAL part341 Cardinal Health OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mg N 20181231 49781-042_21664281-cf91-4943-a5be-c2b03fcd0695 49781-042 HUMAN OTC DRUG Leader Extra Moisturizing Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20130829 OTC MONOGRAPH FINAL part341 Cardinal Health OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mg N 20181231 49781-043_53ccf71f-0f08-4a08-92ea-93225d2a3f32 49781-043 HUMAN OTC DRUG LEADER Sugar Free Cough Drops Black Cherry MENTHOL LOZENGE ORAL 20131125 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 5.8 mg/1 N 20181231 49781-044_eb136fde-c907-47a0-bfb5-aaa74a7ad863 49781-044 HUMAN OTC DRUG Chocolated Laxative Sennosides Stimulant Laxative TABLET, CHEWABLE ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) SENNOSIDES 15 mg/1 E 20171231 49781-045_ad0edecb-408c-4f30-b290-41c886883488 49781-045 HUMAN OTC DRUG Vapor Inhaler Levmetamfetamine Nasal Decongestant INHALANT NASAL 20140301 OTC MONOGRAPH FINAL part341 Cardinal Health (Leader) LEVMETAMFETAMINE 50 mg/1 E 20171231 49781-046_8939d594-0ac6-4ce7-aef9-8b6cf3eb0875 49781-046 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20120625 ANDA ANDA079096 Cardinal Health (Leader) 49781 NAPROXEN SODIUM 220 mg/1 N 20181231 49781-047_1030edf0-5aaa-43b8-b5ef-bf6f30f65e65 49781-047 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20120625 ANDA ANDA079096 Cardinal Health (Leader) 49781 NAPROXEN SODIUM 220 mg/1 N 20181231 49781-048_81800296-ca5c-4ae0-a0e0-516a108b9bd7 49781-048 HUMAN OTC DRUG Leader SleepTime Diphenhydramine HCl SOLUTION ORAL 20131011 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 49781-049_02d4155a-d04c-4774-83e5-72c27e7f6296 49781-049 HUMAN OTC DRUG Leader SleepTime Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20131202 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49781-050_99cbd85c-58de-4878-9b22-81f7ff059018 49781-050 HUMAN OTC DRUG Leader Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20140220 OTC MONOGRAPH FINAL part335 Cardinal Health BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 49781-051_e8538b31-aa69-41d5-9cfd-05002e5bea7d 49781-051 HUMAN OTC DRUG Leader Acid Control Ranitidine TABLET, FILM COATED ORAL 20110525 ANDA ANDA091429 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 49781-052_ce605a19-3a32-4255-a775-b9466c9db0dd 49781-052 HUMAN OTC DRUG Leader Day Time acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20131112 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 49781-053_3acd58a4-6308-4f1d-810d-a50a869dd96c 49781-053 HUMAN OTC DRUG Leader Childrens Mucus Relief Multi Symptom Cold dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20131122 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 49781-054_e940230f-8efa-4e6e-8f06-f4351b14f794 49781-054 HUMAN OTC DRUG leader nite time severe cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20131121 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 49781-055_6c2a735a-7283-436a-a038-8df56f65da09 49781-055 HUMAN OTC DRUG Leader Day Time acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20131121 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49781-056_d9d198c6-5e05-48aa-8ba8-fee836a9e376 49781-056 HUMAN OTC DRUG Leader Severe Sinus Congestion Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20131121 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49781-057_e3d361ba-e117-40ad-a7b6-1bacd7375435 49781-057 HUMAN OTC DRUG Leader Sinus and Cold-D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20131105 ANDA ANDA076518 Cardinal Health NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 49781-058_17e6e28a-f156-4777-8bcb-24f78ef56c32 49781-058 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl TABLET ORAL 20110928 OTC MONOGRAPH FINAL part336 Cardinal Health (Leader) 49781 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49781-059_c8cb10dc-6121-471f-9772-44b9b16f06d5 49781-059 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Cardinal Health (Leader) 49781 DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 49781-060_d8596968-4c1c-47bb-ba0c-82d4b73da009 49781-060 HUMAN OTC DRUG Leader Adult Tussin Mucus Plus Chest Congestion Guaifenesin SOLUTION ORAL 19900415 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 200 mg/10mL N 20181231 49781-061_1d6c3011-4279-485a-8b72-a21da75e16a8 49781-061 HUMAN OTC DRUG Leader Loperamide Hydrochloride loperamide HCl SUSPENSION ORAL 20140423 ANDA ANDA091292 Cardinal Health LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 49781-062_c9125838-6f87-423d-99ce-bd88851e6680 49781-062 HUMAN OTC DRUG Leader Pain Relief 8 HR Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140123 ANDA ANDA075077 Cardinal Health ACETAMINOPHEN 650 mg/1 N 20181231 49781-063_fe2e2371-a9c3-4801-af01-a040633879ee 49781-063 HUMAN OTC DRUG Leader Arthritis Pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140123 ANDA ANDA075077 Cardinal Health ACETAMINOPHEN 650 mg/1 N 20181231 49781-064_ac9f13e6-1f2c-4060-b9b1-b0774516d49b 49781-064 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20140531 ANDA ANDA074164 Cardinal Health (Leader) MICONAZOLE NITRATE 20 mg/g N 20181231 49781-065_04513a18-9f20-4ecd-9c2e-62595452e91c 49781-065 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 20200515 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 49781-067_f275b6cb-cb34-4992-a6f7-39a09193d23d 49781-067 HUMAN OTC DRUG Leader Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20140207 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49781-071_525cc513-9945-43fe-af1b-e168d562a1db 49781-071 HUMAN OTC DRUG Leader Congestion Relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20140915 ANDA ANDA203200 Cardinal Health IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20181231 49781-074_728b6944-75c8-41f0-9965-23729a689e4f 49781-074 HUMAN OTC DRUG Leader Nite Time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140123 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 49781-075_b8c16af4-16f0-498b-8f3e-3c6f7f1edf48 49781-075 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140113 ANDA ANDA077958 Cardinal Health KETOTIFEN FUMARATE .35 mg/mL N 20181231 49781-077_601add8a-fa6f-f308-e053-2a91aa0a6b4f 49781-077 HUMAN OTC DRUG Leader Hemorrholidal Mineral Oil, Petrolatum, Phenylephrine Hydrochloride OINTMENT TOPICAL 20131210 OTC MONOGRAPH FINAL part346 Cardinal Health MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/g; mg/g; mg/g N 20181231 49781-078_c340fbc9-bf97-462b-a777-b10cbbbbeab4 49781-078 HUMAN OTC DRUG Allergy Eye Drops Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140113 ANDA ANDA077958 Cardinal Health KETOTIFEN FUMARATE .35 mg/mL N 20181231 49781-079_3cdb4406-8a0b-4783-aab1-848b73f7629d 49781-079 HUMAN OTC DRUG Leader Acid Control Ranitidine TABLET, FILM COATED ORAL 20140311 ANDA ANDA091429 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 49781-080_54e8ce60-7c76-440f-b6e1-0860d99f36c9 49781-080 HUMAN OTC DRUG Pediatric Glycerin Laxative GLYCERIN SUPPOSITORY RECTAL 20140401 OTC MONOGRAPH NOT FINAL part334 Cardinal Health, Inc. GLYCERIN 1 g/1 N 20181231 49781-081_7a5e0b45-5bfc-4a24-a25e-d71fafbaf9ac 49781-081 HUMAN OTC DRUG Adult Glycerin Laxative GLYCERIN SUPPOSITORY RECTAL 20140401 OTC MONOGRAPH NOT FINAL part334 Cardinal Health, Inc. GLYCERIN 2 g/1 N 20181231 49781-083_2b839fb3-6dd4-42c2-ba99-fdaa1272cd3b 49781-083 HUMAN OTC DRUG Leader Extra Strength Medicated Pain Relief Patch Menthol PATCH TOPICAL 20140325 OTC MONOGRAPH NOT FINAL part348 Cardinal Health MENTHOL 50 mg/g N 20181231 49781-084_8435bba9-abf7-473a-88b7-a29c00592c3c 49781-084 HUMAN OTC DRUG Leader Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20140920 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 81 mg/1 N 20181231 49781-087_738a0339-dc6f-413f-b9f2-8a0f1c231e74 49781-087 HUMAN OTC DRUG Leader Ibuprofen 200 Ibuprofen TABLET ORAL 20140723 ANDA ANDA079129 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 49781-088_93eb0033-b25c-4e1f-8027-cd92e18fc8a2 49781-088 HUMAN OTC DRUG Leader Extra Strength Pain Relief Acetaminophen TABLET ORAL 20140823 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 500 mg/1 N 20181231 49781-089_6f421dda-eed1-41bd-98f2-ffa2fb41f6ec 49781-089 HUMAN OTC DRUG leader loperamide Loperamide Hydrochloride SUSPENSION ORAL 20140530 ANDA ANDA091292 Cardinal Health LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 49781-090_2dcad275-3d50-42a1-a7b4-2fd0d1878039 49781-090 HUMAN OTC DRUG Leader Glycerin, Petrolatum, Phenylephrine Hydrochloride and Pramoxine Hydrochloride CREAM RECTAL 20140428 OTC MONOGRAPH FINAL part346 Cardinal Health GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 144; 150; 2.5; 10 mg/L; mg/L; mg/L; mg/L N 20191231 49781-091_cb63faac-995c-4868-9980-e433005b2a85 49781-091 HUMAN OTC DRUG Leader phenylephrine hydrochloride and witch hazel CREAM RECTAL 20140428 OTC MONOGRAPH FINAL part346 Cardinal Health PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 2.5; 500 mg/L; mg/L N 20191231 49781-092_65823825-1cc7-4aae-a10d-63d9ebb2f940 49781-092 HUMAN OTC DRUG Leader Anti-Itch Maximum Strength Benzocaine and Resorcinol CREAM TOPICAL 20130519 OTC MONOGRAPH FINAL part346 Cardinal Health BENZOCAINE; RESORCINOL 200; 30 mg/g; mg/g N 20191231 49781-093_4163e89f-0469-4080-937f-d20f0ef19353 49781-093 HUMAN OTC DRUG Leader Anti-Itch Regular Strength Benzocaine and Resorcinol CREAM TOPICAL 20140519 OTC MONOGRAPH FINAL part346 Cardinal Health BENZOCAINE; RESORCINOL 50; 20 mg/g; mg/g N 20191231 49781-094_9a159f37-c369-493d-9d4b-fedf6a4f2280 49781-094 HUMAN OTC DRUG Leader Aspirin Aspirin TABLET, CHEWABLE ORAL 20140920 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 81 mg/1 N 20181231 49781-095_688f138a-45d7-477f-988b-fb991ece1d4f 49781-095 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140920 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 325 mg/1 N 20181231 49781-096_761b3a57-a538-4698-a09d-2917a29081b5 49781-096 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140920 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 325 mg/1 N 20181231 49781-097_c6c75bb4-3a9d-4562-bb5c-773e0b71fece 49781-097 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140920 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 81 mg/1 N 20181231 49781-098_c9ab0ad0-600c-4795-a29a-4b28a62f90d4 49781-098 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140731 OTC MONOGRAPH NOT FINAL part356 Cardinal Health (Leader) 49781 PHENOL 1.4 g/100mL N 20181231 49781-099_a47c4dd4-9955-4564-8167-6f10875ee966 49781-099 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ALCOHOL 70 mL/100mL N 20181231 49781-100_3b82c438-2272-466b-a5e0-34bfe6c2c6b4 49781-100 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140731 ANDA ANDA091353 Cardinal Health (Leader) 49781 NAPROXEN SODIUM 220 mg/1 N 20181231 49781-101_37be6747-1ad2-405b-9e55-67e4b91c0626 49781-101 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140731 ANDA ANDA091353 Cardinal Health (Leader) 49781 NAPROXEN SODIUM 220 mg/1 N 20181231 49781-102_631c5a65-0a5c-4196-a48f-3a6cb9055431 49781-102 HUMAN OTC DRUG Leader Nicotine Nicotine Polacrilex LOZENGE ORAL 20141110 ANDA ANDA203690 Cardinal Health NICOTINE 4 mg/1 N 20181231 49781-103_112a11c3-efee-4e99-b4d9-3818564e9c2e 49781-103 HUMAN OTC DRUG Leader Nicotine Nicotine Polacrilex LOZENGE ORAL 20141110 ANDA ANDA203690 Cardinal Health NICOTINE 2 mg/1 N 20181231 49781-104_8fafba41-76ee-4f52-9e45-f50e3ff0312b 49781-104 HUMAN OTC DRUG Leader Pain Reliever Acetaminophen TABLET ORAL 20140519 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 325 mg/1 N 20181231 49781-105_5e21b366-476f-1ca9-e053-2a91aa0a876f 49781-105 HUMAN OTC DRUG Leader Poison Ivy Wash Pramoxine Hydrochloride LOTION TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part348 Cardinal Health PRAMOXINE HYDROCHLORIDE 10 mg/mL N 20181231 49781-106_bf876705-d66c-46f5-a902-c017b5e9a8af 49781-106 HUMAN OTC DRUG leader all day allergy Cetirizine Hydrochloride TABLET ORAL 20140604 ANDA ANDA078336 Cardinal Health CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 49781-108_c7238549-4eb4-4603-9f70-f2b793b54d97 49781-108 HUMAN OTC DRUG LEADER Hydrogen Peroxide Wipes HYDROGEN PEROXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333A Cardinal Health HYDROGEN PEROXIDE 3 g/100g N 20181231 49781-109_c3384ddd-7cc7-4c7e-8377-eef944f55fe8 49781-109 HUMAN OTC DRUG LEADER ISOPROPYL Alcohol Wipes ISOPROPYL ALCOHOL LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL 70 g/100g N 20181231 49781-111_b5cce596-b285-4cf9-a5c8-1bdeadfc245b 49781-111 HUMAN OTC DRUG Leader Lip Treatment Petrolatum GEL TOPICAL 20130502 OTC MONOGRAPH FINAL part347 Cardinal Health (Leader) PETROLATUM 99.98 mg/g N 20181231 49781-112_64c42b1f-db62-44d5-903f-227efb23e93d 49781-112 HUMAN OTC DRUG Leader Medicated Lip Balm Petrolatum STICK TOPICAL 20130401 OTC MONOGRAPH FINAL part347 Cardinal Health (Leader) PETROLATUM 41 mg/g N 20181231 49781-113_89847ce8-136a-44e1-ab93-0f94a6aa3295 49781-113 HUMAN OTC DRUG Restfully Sleep Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 20200810 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49781-114_99c585f9-0858-4899-9db0-0c0727adfed5 49781-114 HUMAN OTC DRUG Salicylic Acid One Step Clear Wart Remover PATCH TOPICAL 20100201 OTC MONOGRAPH FINAL part358B Cardinal Health SALICYLIC ACID 40 mg/141 N 20181231 49781-115_616a896a-d21e-7f7c-e053-2a91aa0a0f5b 49781-115 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20011001 OTC MONOGRAPH FINAL part358F Cardinal Health Inc. SALICYLIC ACID .17 g/g N 20181231 49781-116_ad474fa5-948c-44a7-b8d0-c1b46864ab30 49781-116 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20100201 OTC MONOGRAPH FINAL part358F Cardinal Health SALICYLIC ACID 40 mg/41 N 20181231 49781-117_7921f741-700b-426a-b7e8-6054bd4ae0b3 49781-117 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20100201 OTC MONOGRAPH FINAL part358F Cardinal Health SALICYLIC ACID 40 mg/91 N 20181231 49781-118_616a3261-68ae-1dc8-e053-2991aa0a2c61 49781-118 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20041001 OTC MONOGRAPH FINAL part358F Cardinal Health Inc. SALICYLIC ACID .17 g/g N 20181231 49781-119_30c1a312-cc80-494d-ac77-0978badf32f2 49781-119 HUMAN OTC DRUG Leader Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20140930 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 1000 mg/1 N 20181231 49781-120_066b9593-1d9b-4204-ab48-11dd581f2a21 49781-120 HUMAN OTC DRUG leader antacid calcium carbonate TABLET, CHEWABLE ORAL 20140930 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 1000 mg/1 N 20181231 49781-121_cfe98436-3377-46c0-bc72-3adb91ebb6fc 49781-121 HUMAN OTC DRUG Leader Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20140930 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 1000 mg/1 N 20181231 49781-122_12e7b9fb-8aca-4d35-ba6b-3f6f2ecfb7ae 49781-122 HUMAN OTC DRUG Leader Sinus Relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20161003 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 49781-123_1e412989-20bd-40f4-8d9b-d5139aa8db3d 49781-123 HUMAN OTC DRUG leader cold and flu Acetaminophen, diphenhydramine HCl, phenylephrine HCl TABLET, FILM COATED ORAL 20151019 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 49781-124_1baaeecc-4e86-40cb-ae22-a262d138961a 49781-124 HUMAN OTC DRUG Leader Sinus Relief Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20150803 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 49781-125_2220cea6-9e8e-4be6-83f0-1c8ac76564bc 49781-125 HUMAN OTC DRUG Leader Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20150713 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49781-126_a2c0d196-6933-4883-aafb-38a6f8c20ff6 49781-126 HUMAN OTC DRUG leader flu and severe cold and cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20141031 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 49781-127_027c34d5-b741-4053-8726-7954058fd9e4 49781-127 HUMAN OTC DRUG leader flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20141027 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 49781-129_eda5b0c4-8dd7-411b-8a56-3879c68e233f 49781-129 HUMAN OTC DRUG leader ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20150313 ANDA ANDA072096 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 49781-130_e212f3d8-d2ae-4a82-bba1-0dd3129cb905 49781-130 HUMAN OTC DRUG leader ibuprofen Ibuprofen TABLET, COATED ORAL 20150324 ANDA ANDA072096 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 49781-131_94b715e1-31cc-4bcf-b1d9-3648a9182bc8 49781-131 HUMAN OTC DRUG Leader Gentle Laxative Bisacodyl SUPPOSITORY RECTAL 20150213 OTC MONOGRAPH NOT FINAL part334 Cardinal Health BISACODYL 10 mg/2000mg N 20181231 49781-132_5de4dbad-f4a9-45d0-96d0-b74ca07110a4 49781-132 HUMAN OTC DRUG Leader Nausea Relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20150709 UNAPPROVED DRUG OTHER Cardinal Health DEXTROSE; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 49781-136_8dc33b53-2a8e-4ab4-bbbf-a1c3e2fc71e9 49781-136 HUMAN OTC DRUG leader nasal Oxymetazoline HCl SPRAY NASAL 20141204 OTC MONOGRAPH FINAL part341 Cardinal Health OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 49781-138_f534cedf-40f2-4653-b3eb-92caeb3725ca 49781-138 HUMAN OTC DRUG leader cough dm dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150403 ANDA ANDA091135 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 49781-139_845814a6-d19a-4416-8349-64cd6b1acdf2 49781-139 HUMAN OTC DRUG Leader Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20150115 UNAPPROVED DRUG OTHER Cardinal Health PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 49781-142_b112553b-e7ac-5feb-9d32-78739c3804cf 49781-142 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20151001 NDA NDA020076 Cardinal Health (Leader) NICOTINE 21 mg/24h N 20181231 49781-143_b112553b-e7ac-5feb-9d32-78739c3804cf 49781-143 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20151001 NDA NDA020076 Cardinal Health (Leader) NICOTINE 7 mg/24h N 20181231 49781-144_b112553b-e7ac-5feb-9d32-78739c3804cf 49781-144 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20151001 NDA NDA020076 Cardinal Health (Leader) NICOTINE 14 mg/24h N 20181231 49781-145_a2ac502c-60e8-479d-a4c0-1862d0fd19aa 49781-145 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20151130 ANDA ANDA079096 Cardinal Health (Leader) 49781 NAPROXEN SODIUM 220 mg/1 N 20181231 49781-146_b6760742-e41a-46fd-82d2-a33a0513b78e 49781-146 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20151130 ANDA ANDA079096 Cardinal Health (Leader) 49781 NAPROXEN SODIUM 220 mg/1 N 20181231 49781-147_18e2956f-b3e5-4bea-bdb2-cca84ae5041a 49781-147 HUMAN OTC DRUG Allergy Diphenhydramine HCl CAPSULE ORAL 20160131 OTC MONOGRAPH FINAL part341 Cardinal Health (Leader) 49781 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49781-148_517608cd-157e-4e62-a06d-eae030cd996e 49781-148 HUMAN OTC DRUG Senna laxative Sennosides TABLET ORAL 20160229 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) 49781 SENNOSIDES 8.6 mg/1 N 20181231 49781-149_1da5e841-b1f3-4bdc-9368-4a2724f96ec1 49781-149 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) 49781 DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 49781-150_9bbe5b40-d6ab-410e-a3b9-e141b1f04b53 49781-150 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 Cardinal Health (Leader) 49781 DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 49789-050_e9ad6a60-d765-4fa6-a155-b7e1e1bfc733 49789-050 HUMAN OTC DRUG PROBUFEN IBUPROFEN TABLET ORAL 20111201 OTC MONOGRAPH NOT FINAL part343 SAMSUNG PHARM IND. CO., LTD. IBUPROFEN 400 mg/537mg E 20171231 49789-060_b1cce823-c1c1-4653-8047-fbc087977c58 49789-060 HUMAN OTC DRUG HIS ULC MINT BLUE Calcium carbonate TABLET, CHEWABLE ORAL 20121201 OTC MONOGRAPH FINAL part331 SAMSUNG PHARM IND. CO., LTD. CALCIUM CARBONATE 350 mg/492mg E 20171231 49790-001_74d8d839-3cf1-4fbf-bc2b-4999f577c7f4 49790-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091104 UNAPPROVED MEDICAL GAS Allen's Cylinder Testing & Inspection Company OXYGEN 992 mL/L E 20171231 49794-003_d39d1621-4d46-4c22-a0ad-dd78fc4313ef 49794-003 HUMAN OTC DRUG Ear Wax Removal Aid Carbamide Peroxide LIQUID AURICULAR (OTIC) 20100827 OTC MONOGRAPH FINAL part344 Continental Manufacturing Chemist, Inc. CARBAMIDE PEROXIDE 6.5 mg/100mL E 20171231 49794-009_ced19de1-ff9a-4d6b-868c-45164e65e05c 49794-009 HUMAN OTC DRUG Antibacterial Alcohol GEL TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333A Continental Manufacturing Chemist, Inc. ALCOHOL 620 g/kg E 20171231 49794-010_6ee89d0f-fb5a-4229-bc4c-eb85c28966ad 49794-010 HUMAN OTC DRUG Antibacterial Ethyl Alcohol LIQUID TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333A Continental Manufacturing Chemist, Inc. ALCOHOL 620 g/L E 20171231 49794-048_3110ce92-5a57-4dd5-84a0-aebaa5f0678a 49794-048 HUMAN OTC DRUG SPF-15 Sunscreen Octocrylene, Avobenzone LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Continental Manufacturing Chemist, Inc. OCTOCRYLENE; AVOBENZONE 100; 30 g/L; g/L E 20171231 49795-227_8a7de862-5193-4363-aeab-e87ec4a13e68 49795-227 HUMAN OTC DRUG Pro-Flex Camphor, Menthol CREAM TOPICAL 20040201 OTC MONOGRAPH NOT FINAL part348 Nutri-Dyn Products Ltd. dba Professional Health Products CAMPHOR (NATURAL); MENTHOL 4; 4 g/100g; g/100g E 20171231 49795-416_2ca61eb1-40d1-4811-80d1-bc102ccc2208 49795-416 HUMAN OTC DRUG Professional Therapy Muscle Care Pain Relieving Gel by Dr. Chris Oswald Maximum Strength Menthol, Camphor GEL TOPICAL 20100115 OTC MONOGRAPH NOT FINAL part348 Nutri-Dyn Products Ltd. dba Professional Health Products MENTHOL; CAMPHOR 10; 4 g/100g; g/100g E 20171231 49795-417_a0ab277f-141c-4718-9f79-92775d1a61c2 49795-417 HUMAN OTC DRUG Professional Therapy Muscle Care Pain Relieving Ointment by Dr. Chris Oswald Maximum Strength Camphor, Menthol CREAM TOPICAL 20100115 OTC MONOGRAPH NOT FINAL part348 Nutri-Dyn Products Ltd. dba Professional Health Products CAMPHOR; MENTHOL 4; 4 g/100g; g/100g E 20171231 49795-809_13ebda7d-fe67-4c51-a2c9-98669867d711 49795-809 HUMAN OTC DRUG Motion Medicine Camphor, Menthol CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part348 Nutri-Dyn Products Ltd. dba Professional Health Products CAMPHOR (NATURAL); MENTHOL 4; 4 g/100g; g/100g E 20171231 49798-001_0e089773-e9d9-43f7-af1f-944103c208e6 49798-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19560101 NDA NDA205767 James Oxygen and Supply Company OXYGEN 992 mL/L N 20181231 49799-001_819a51e5-bd40-4f7e-ab91-61c69d789986 49799-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091001 UNAPPROVED MEDICAL GAS Medical Equipment and Supplies of America, LLC OXYGEN 99 L/100L E 20171231 49804-101_5e3e64e8-adb5-4072-a226-732d7ca75f57 49804-101 HUMAN OTC DRUG hybrid CF APAP 500 mg Phenylephrine HCL 5 mg Chlorpheniramine maleate 2 mg TABLET, FILM COATED ORAL 20100203 OTC MONOGRAPH FINAL part341 Hybrid-Rx LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE 500; 5; 2 mg/1; mg/1; mg/1 E 20171231 49811-001_185c655b-7233-4398-948d-f47cd0b18a3d 49811-001 HUMAN OTC DRUG Amari Silicea, Zincum Oxidatum CREAM TOPICAL 20080831 UNAPPROVED HOMEOPATHIC Pacific Media Direct, LLC SILICON DIOXIDE; ZINC OXIDE .85; .085 g/4.25g; g/4.25g E 20171231 49817-0063_95293750-2aab-4d17-9b4d-23d9e6cff287 49817-0063 HUMAN OTC DRUG TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 LIGHT 01 OCTINOXATE POWDER TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain OCTINOXATE 25 mg/mL N 20181231 49817-0064_76f99b55-46c4-47e1-b41e-1c2dc24f2c50 49817-0064 HUMAN OTC DRUG TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 02 MEDIUM OCTINOXATE POWDER TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Guerlain OCTINOXATE 25 mg/mL N 20181231 49817-0067_e12b62fd-14e7-4953-bb36-098820f303a8 49817-0067 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 01 BEIGE PALE TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain TITANIUM DIOXIDE 29.2 mg/mL N 20181231 49817-0068_903cf5d8-2c24-4878-b096-bc9825bd6866 49817-0068 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 02 BEIGE CLAIR TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain TITANIUM DIOXIDE 29.2 mg/mL N 20181231 49817-0069_ff12da7c-fbcf-42dc-8f1a-3cb036eb8be7 49817-0069 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 03 BEIGE NATUREL TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain TITANIUM DIOXIDE 29.2 mg/mL N 20181231 49817-0070_e3f1529a-752b-47ac-8d1d-40c79f56023e 49817-0070 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 04 BEIGE MOYEN TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain TITANIUM DIOXIDE 29.2 mg/mL N 20181231 49817-0071_0b3df17e-082f-4b10-969d-83948fd89a28 49817-0071 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 12 ROSE CLAIR TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain TITANIUM DIOXIDE 29.2 mg/mL N 20181231 49817-0072_8584a677-8714-4127-97ac-b69a51e08666 49817-0072 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 13 ROSE NATUREL TITANIUM DIOXIDE LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain TITANIUM DIOXIDE 29.2 mg/mL N 20181231 49817-0073_0a24b95d-2443-47c9-909f-646eca7b5043 49817-0073 HUMAN OTC DRUG TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 EBONY OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 43.8 mg/mL; mg/mL N 20181231 49817-0074_d32b9b43-abdb-42b7-81b6-af09a804a299 49817-0074 HUMAN OTC DRUG TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 DARK OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 43.8 mg/mL; mg/mL N 20181231 49817-0075_deace444-4310-4696-b2cf-43f9a2d0f1d9 49817-0075 HUMAN OTC DRUG TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 MEDIUM OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 43.8 mg/mL; mg/mL N 20181231 49817-0076_5d1d8827-af21-4c60-b0da-74367a731168 49817-0076 HUMAN OTC DRUG TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 NATURAL OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 43.8 mg/mL; mg/mL N 20181231 49817-0077_aad80f51-7360-4326-8229-465007a6eb6c 49817-0077 HUMAN OTC DRUG TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 LIGHT OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 43.8 mg/mL; mg/mL N 20181231 49817-0078_e17d9bf4-39e6-4115-a378-2e122f577d60 49817-0078 HUMAN OTC DRUG SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 LIGHT OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 74.9; 38.4 mg/mL; mg/mL N 20181231 49817-0079_f9a91687-d200-4c2d-b8f5-cc9af21b7fbc 49817-0079 HUMAN OTC DRUG SUPER AQUA-SERUM BB HYDRA BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF 25 MEDIUM OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 74.9; 38.4 mg/mL; mg/mL N 20181231 49817-0080_75aba2e7-af5c-4270-8de7-53560185a969 49817-0080 HUMAN OTC DRUG LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 LIGHT OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.4; 10; 35.5 mg/mL; mg/mL; mg/mL N 20181231 49817-0081_b8516a67-a38d-4aef-8dc7-57a39bed9145 49817-0081 HUMAN OTC DRUG LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 MEDIUM OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.4; 10; 35.5 mg/mL; mg/mL; mg/mL N 20181231 49817-0083_8c9832d3-00ef-4968-98ea-4c6255d9d7ee 49817-0083 HUMAN OTC DRUG METEORITES BABY GLOW BROAD SPECTRUM SPF 25 2 LIGHT OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 54.9; 21.9 mg/mL; mg/mL N 20181231 49817-0084_476b47e6-18d5-693c-e054-00144ff8d46c 49817-0084 HUMAN OTC DRUG METEORITES BABY GLOW BROAD SPECTRUM SPF 25 3 MEDIUM OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 54.9; 21.9 mg/mL; mg/mL N 20181231 49817-0085_5c6c6933-7831-44f0-a2e2-1f0d229a7c8a 49817-0085 HUMAN OTC DRUG METEORITES BABY GLOW BROAD SPECTRUM SPF 25 4 GOLDEN OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20141020 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 54.9; 21.9 mg/mL; mg/mL N 20181231 49817-0089_e7308efb-1f5f-4bd4-8f92-3e60415635c2 49817-0089 HUMAN OTC DRUG ORCHIDEE IMPERIALE - EXCEPTIONAL COMPLETE CARE - THE UV BEAUTY PROTECTOR WITH SUNSCREEN BROAD SPECTRUM SPF 50 UNIVERSAL SHADE OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 74.9; 20; 67.4 mg/mL; mg/mL; mg/mL N 20181231 49817-1986_8d142844-baf4-40b8-8dee-279f865391ff 49817-1986 HUMAN OTC DRUG Fresh Sugar Roll-On Deodorant Antiperspirant aluminum chlorohydrate LIQUID TOPICAL 20020501 OTC MONOGRAPH FINAL part350 Guerlain ALUMINUM CHLOROHYDRATE 15 g/100g E 20171231 49817-1987_53cabb11-252a-44dd-b7dd-974e004e23aa 49817-1987 HUMAN OTC DRUG Fresh Sugar Honey Tinted Lip Treatment SPF15 octinoxate and oxybenzone LIPSTICK TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE 7.49; 2 g/100g; g/100g E 20171231 49817-1988_850cf12e-7152-4bfc-82fa-d882cd7d5ad2 49817-1988 HUMAN OTC DRUG Fresh Sugar Rose Tinted Lip Treatment SPF 15 octinoxate and oxybenzone LIPSTICK TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE 7.49; 2 g/100g; g/100g E 20171231 49817-1989_8ed54a06-b651-42cc-8e30-f287b2c9831a 49817-1989 HUMAN OTC DRUG Fresh Sugar Plum Tinted Lip Treatment SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE 7.49; 2 g/100g; g/100g E 20171231 49817-1990_a858d752-bfb6-4d52-a4ba-6744576f15c0 49817-1990 HUMAN OTC DRUG Fresh Sugar Lip Treatment SPF 15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20030601 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE 7.49; 2 g/100g; g/100g E 20171231 49817-2001_30c479fd-3301-63d6-e054-00144ff88e88 49817-2001 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 00N PORCELAINE PORCELAIN OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160413 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2002_30c479fd-32e0-63d6-e054-00144ff88e88 49817-2002 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 02C CLAIR ROSE LIGHT COOL OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160413 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2003_30c487d1-b2b3-6245-e054-00144ff8d46c 49817-2003 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 02N CLAIR LIGHT OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160413 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2004_30c479fd-3323-63d6-e054-00144ff88e88 49817-2004 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 02W CLAIR DORE LIGHT WARM OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160413 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2005_30c487d1-b282-6245-e054-00144ff8d46c 49817-2005 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 03C NATUREL ROSE NATURAL COOL OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160413 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2006_30c479fd-32c0-63d6-e054-00144ff88e88 49817-2006 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 03N NATUREL NATURAL OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2007_30c479fd-3312-63d6-e054-00144ff88e88 49817-2007 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 03W NATUREL DORE NATURAL WARM OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2008_30c487d1-b2a3-6245-e054-00144ff8d46c 49817-2008 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 04C MOYEN ROSE MEDIUM COOL OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2009_30c479fd-3343-63d6-e054-00144ff88e88 49817-2009 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 04N MOYEN MEDIUM OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2010_30c479fd-3333-63d6-e054-00144ff88e88 49817-2010 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 04W MOYEN DORE MEDIUM WARM OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2011_30c487d1-b2c3-6245-e054-00144ff8d46c 49817-2011 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 05C FONCE ROSE DEEP COOL OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2012_30c479fd-32d0-63d6-e054-00144ff88e88 49817-2012 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 05N FONCE DEEP OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2013_30c479fd-32f0-63d6-e054-00144ff88e88 49817-2013 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 03N NATUREL NATURAL OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2014_30c487d1-b292-6245-e054-00144ff8d46c 49817-2014 HUMAN OTC DRUG LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 06W TRES FONCE DORE VERY DEEP WARM OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 49817-2015_4fa8cdf8-e716-6f46-e054-00144ff88e88 49817-2015 HUMAN OTC DRUG LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 02N LIGHT OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20170513 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 30.4 mg/mL; mg/mL N 20181231 49817-2016_4fa8cdf8-e726-6f46-e054-00144ff88e88 49817-2016 HUMAN OTC DRUG LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 06W VERY DEEP WARM OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20170513 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 30.4 mg/mL; mg/mL N 20181231 49817-2017_4fa8cdf8-e736-6f46-e054-00144ff88e88 49817-2017 HUMAN OTC DRUG LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 05W DEEP WARM OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20170513 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 30.4 mg/mL; mg/mL N 20181231 49817-2018_4fa8cdf8-e746-6f46-e054-00144ff88e88 49817-2018 HUMAN OTC DRUG LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 04N MEDIUM OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 30.4 mg/mL; mg/mL N 20181231 49817-2019_4fa8cced-4cb9-71f2-e054-00144ff88e88 49817-2019 HUMAN OTC DRUG LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 03W NATURAL WARM OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20170504 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 30.4 mg/mL; mg/mL N 20181231 49817-2020_4fa8cced-4cc9-71f2-e054-00144ff88e88 49817-2020 HUMAN OTC DRUG LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 03N NATURAL OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 30.4 mg/mL; mg/mL N 20181231 49817-2021_4fa8cced-4cd7-71f2-e054-00144ff88e88 49817-2021 HUMAN OTC DRUG LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 02C LIGHT COOL OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 30.4 mg/mL; mg/mL N 20181231 49817-2022_4fb7ecda-8155-217a-e054-00144ff88e88 49817-2022 HUMAN OTC DRUG LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 01N VERY LIGHT OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 30.4 mg/mL; mg/mL N 20181231 49817-2023_4fa8cced-4ce6-71f2-e054-00144ff88e88 49817-2023 HUMAN OTC DRUG LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 00N PORCELAIN OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20170504 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; TITANIUM DIOXIDE 39.9; 30.4 mg/mL; mg/mL N 20181231 49817-2024_58b11150-f9ff-37b7-e053-2991aa0aba39 49817-2024 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 01 BEIGE PALE TITANIUM DIOXIDE EMULSION TOPICAL 20170908 OTC MONOGRAPH NOT FINAL part352 Guerlain TITANIUM DIOXIDE 29.2 mg/mL N 20181231 49817-2025_58b14d30-cd0c-754a-e053-2991aa0a36d3 49817-2025 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 02 BEIGE CLAIR TITANIUM DIOXIDE EMULSION TOPICAL 20170908 OTC MONOGRAPH NOT FINAL part352 Guerlain TITANIUM DIOXIDE 29.2 mg/mL N 20181231 49817-2026_58b1676d-1265-5c90-e053-2991aa0afb15 49817-2026 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 03 BEIGE NATUREL TITANIUM DIOXIDE EMULSION TOPICAL 20170908 OTC MONOGRAPH NOT FINAL part352 Guerlain TITANIUM DIOXIDE 29.2 mg/mL N 20181231 49817-2027_58b17e77-5558-2e8d-e053-2a91aa0a2dc8 49817-2027 HUMAN OTC DRUG TENUE DE PERFECTION TIMEPROOF FOUNDATION WITH SUNSCREEN ULTIMATE LASTING PERFECTION BROAD SPECTRUM SPF 20 04 BEIGE MOYEN TITANIUM DIOXIDE EMULSION TOPICAL 20170908 OTC MONOGRAPH NOT FINAL part352 Guerlain TITANIUM DIOXIDE 29.2 mg/mL N 20181231 49817-2028_58e92ebe-ac01-69e7-e053-2991aa0a3efd 49817-2028 HUMAN OTC DRUG LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 BB 2 LIGHT OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE EMULSION TOPICAL 20170908 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.4; 10; 35.5 mg/mL; mg/mL; mg/mL N 20181231 49817-2029_58e92ebe-ac11-69e7-e053-2991aa0a3efd 49817-2029 HUMAN OTC DRUG LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 BB 3 NATURAL OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE EMULSION TOPICAL 20170908 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.4; 10; 35.5 mg/mL; mg/mL; mg/mL N 20181231 49817-2030_58e977fd-1e35-5323-e053-2a91aa0a99c1 49817-2030 HUMAN OTC DRUG LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 BB 4 MEDIUM OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE EMULSION TOPICAL 20170908 OTC MONOGRAPH NOT FINAL part352 Guerlain OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.4; 10; 35.5 mg/mL; mg/mL; mg/mL N 20181231 49825-070_cc43dbee-189a-4fa7-a813-e9755a826439 49825-070 HUMAN OTC DRUG FORME COSMETICS DELICIOUS LIP BALM SPF 12 TITANIUM DIOXIDE, OCTINOXATE, AVOBENZONE LIPSTICK TOPICAL 20091022 OTC MONOGRAPH NOT FINAL part352 CHROMAVIS SPA TITANIUM DIOXIDE; AVOBENZONE; OCTINOXATE .04128; .048; .192 g/3.2g; g/3.2g; g/3.2g E 20171231 49825-111_f9832814-3ee2-457b-aee8-b6fd421b16c4 49825-111 HUMAN PRESCRIPTION DRUG Bioelements Active Astringent Salicylic Acid LIQUID TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Bioelements SALICYLIC ACID .5 mL/100mL N 20181231 49825-112_b2b61a68-fe3e-4569-9da5-388e3cd97779 49825-112 HUMAN OTC DRUG Bioelements Amino Mask Salicylic Acid CREAM TOPICAL 20090101 OTC MONOGRAPH FINAL part358H Bioelements SALICYLIC ACID 2 mL/100mL N 20181231 49825-113_87645f39-f53a-463a-b956-e4172f3ecdb2 49825-113 HUMAN OTC DRUG Bioelements Spotless Cleanser Salicylic Acid GEL TOPICAL 20100505 OTC MONOGRAPH FINAL part358H Bioelements Inc. SALICYLIC ACID 2 mL/100mL N 20181231 49825-114_19d7afa4-cd7c-4876-91f7-cf916fa73748 49825-114 HUMAN OTC DRUG Bioelements Sun Diffusing Protector SPF 15 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Bioelements Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 3; .01; .01 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49825-116_9396b4e0-a337-48a4-b530-c8785c96c772 49825-116 HUMAN OTC DRUG Bioelements Breakout Control Benzoyl Peroxide CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333D Bioelements, Inc. BENZOYL PEROXIDE 2.5 mL/100mL N 20181231 49825-117_059a477f-0046-4d61-8b56-59ffd0c287cd 49825-117 HUMAN OTC DRUG Bioelements, Inc. SPF 50 FaceScreen Homosalate, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 Bioelements, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 7.5; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49825-119_da5d25e6-bce7-4c25-a91a-b83a3e6b54a5 49825-119 HUMAN OTC DRUG Bioelements Immediate Comfort Hydrocortisone Hydrocortisone LOTION TOPICAL 20100819 OTC MONOGRAPH NOT FINAL part348 Bioelements, Inc. HYDROCORTISONE 1 mL/100mL N 20181231 49825-120_4a581a7c-0a89-4a11-8c2b-e1eefeb61938 49825-120 HUMAN OTC DRUG Sun Diffusing Protector SPF 15 Bioelements Avobenzone, Homosalate, Octocrylene, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20120321 OTC MONOGRAPH FINAL part352 Bioelements Inc AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 2; 7.5; 1.8; 5; .49 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 49825-121_dfc63c1a-873f-4e93-b46e-7ed7d6311773 49825-121 HUMAN OTC DRUG Ray Defense SPF 30 Sunscreen Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone LIQUID TOPICAL 20120323 OTC MONOGRAPH NOT FINAL part352 Bioelements, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 7.5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49825-122_b735fb3d-6a7a-412d-a9c4-2577c6bc9470 49825-122 HUMAN OTC DRUG Facescreen SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene,Oxybenzone LIQUID TOPICAL 20120323 OTC MONOGRAPH NOT FINAL part352 Bioelements AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7; 5; 5; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 49825-123_e77fa75f-9d7f-4749-81e0-9089b3811174 49825-123 HUMAN OTC DRUG Bioelements Amino Mask Sulfur CREAM TOPICAL 20120426 OTC MONOGRAPH FINAL part333D Bioelements SULFUR 5 mL/100mL N 20181231 49825-124_c1266138-fbc3-4663-a73d-6d941851823b 49825-124 HUMAN OTC DRUG Breakout Control Acne Treatment Benzoyl Peroxide LOTION TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part333D Bioelements, Inc. BENZOYL PEROXIDE 5 mL/100mL N 20181231 49825-126_0afc9d3f-47f9-4424-8ad4-2b4b7d34607f 49825-126 HUMAN PRESCRIPTION DRUG Bioelements Immediate Comfort Hydrocortisone Acetate LOTION TOPICAL 20120823 OTC MONOGRAPH NOT FINAL part348 Bioelements, Inc. HYDROCORTISONE ACETATE .088 mL/88mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49825-128_eb3becd1-1d9d-4006-80f7-86193353a0a8 49825-128 HUMAN OTC DRUG Amino Mask Bioelements Sulfur CREAM TOPICAL 20130614 OTC MONOGRAPH FINAL part358H Bioelements SULFUR 5 g/100mL N 20181231 49825-129_dfdfb3a0-e5b5-469d-835b-dd9856f4253f 49825-129 HUMAN OTC DRUG Breakout Control Bioelements Benzoyl Peroxide CREAM TOPICAL 20130614 OTC MONOGRAPH FINAL part333D Bioelements, Inc. BENZOYL PEROXIDE 5 g/100mL N 20181231 49825-130_e1a609b0-d5e6-40e9-9021-efa39188bb5b 49825-130 HUMAN OTC DRUG Acne Toner Biolements Salicylic Acid CREAM TOPICAL 20130617 OTC MONOGRAPH FINAL part333D Bioelements, Inc. SALICYLIC ACID .5 g/100mL N 20181231 49825-131_870c7bde-d419-40e7-8a36-b5c5d8faffd8 49825-131 HUMAN OTC DRUG Spotless Cleanser Bioelements Salicylic Acid CREAM TOPICAL 20130617 OTC MONOGRAPH FINAL part333D Bioelements, Inc. SALICYLIC ACID 2 g/100mL N 20181231 49825-132_5054ad1c-9909-485b-a078-0bde8f0e3981 49825-132 HUMAN OTC DRUG Ray Defense Borad Spectrum SPF 30 sunscreen Biolements Avobenzone , Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part352 Bioelements, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 7; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 49825-133_511ea5f5-7cbd-495f-b252-fbe14ae0bf7c 49825-133 HUMAN OTC DRUG Broad Spectrum SPF 50 Sunscreen Bioelements Avobenzone, Homosalate, Ocinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20130711 OTC MONOGRAPH FINAL part352 Bioelements AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7; 5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 49825-134_2f599a6d-1d8e-4325-b851-f1c2badaff1d 49825-134 HUMAN OTC DRUG Immediate Comfort Bioelements Hydrocortisone Acetate LOTION TOPICAL 20120823 OTC MONOGRAPH NOT FINAL part348 Bioelements, Inc. HYDROCORTISONE ACETATE 1 g/88mL N 20181231 49825-136_e4294319-c352-41a8-9834-d25b45dde50e 49825-136 HUMAN OTC DRUG Acne Toner Acne Clearing System Salicylic Acid LIQUID TOPICAL 20150410 OTC MONOGRAPH FINAL part358B Bioelements SALICYLIC ACID .5 g/.5mL N 20181231 49825-138_58d7bcfe-14e4-4d97-9c79-375811653e06 49825-138 HUMAN OTC DRUG Ray Defense Broad Spectrum SPF 30 Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20150427 OTC MONOGRAPH FINAL part352 Bioelements AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 7; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 49825-201_795d0ec9-0d4d-407b-a076-15d388c894a9 49825-201 HUMAN OTC DRUG SPF 50 Face Sunscreen Bioelements Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20160104 OTC MONOGRAPH FINAL part352 Bioelements AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7; 5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 49834-001_885df0e0-63d4-11e1-a41e-0002a5d5c51b 49834-001 HUMAN OTC DRUG Gellert Joint Care Capsaicin CREAM TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part348 Gellert Health Solutions LLC CAPSAICIN .17 g/100g E 20171231 49836-000_face4e96-82cb-4c2e-b3c2-9a17c432228a 49836-000 HUMAN PRESCRIPTION DRUG P-Care 100MX Bupivacaine Hydrochloride, Lidocaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA016964 RX PHARMA-PACK, INC. N 20181231 49836-001_379f8dac-bd95-4c94-bfef-72e04c4df517 49836-001 HUMAN PRESCRIPTION DRUG P-Care M Bupivacaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA016964 RX PHARMA-PACK, INC. N 20181231 49836-002_6493ec3d-3f78-4bda-b666-3cdbdebf6673 49836-002 HUMAN PRESCRIPTION DRUG P-Care MG Bupivacaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA016964 RX PHARMA-PACK, INC. N 20181231 49836-003_af484973-33a2-4ca7-a61f-14622a8b18d4 49836-003 HUMAN PRESCRIPTION DRUG P-Care X Lidocaine Hydrochloride, Sodium Chloride, Povidone-Iodine, Isopropyl alcohol KIT 20170616 NDA NDA006488 RX PHARMA-PACK, INC. N 20181231 49836-004_26103bba-cb55-44d8-b7fd-88d002c5f6b0 49836-004 HUMAN PRESCRIPTION DRUG P-Care K40MX Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA014901 RX PHARMA-PACK, INC. N 20181231 49836-005_645938c3-5036-4c00-a1c5-cf78a4bd98da 49836-005 HUMAN PRESCRIPTION DRUG P-Care K40G Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA014901 RX PHARMA-PACK, INC. N 20181231 49836-006_07f07dd0-faba-494f-8584-d99362a1c35b 49836-006 HUMAN PRESCRIPTION DRUG P-Care K40 triamcinolone acetonide, povidone-iodine, isopropyl alcohol KIT 20170616 NDA NDA014901 RX PHARMA-PACK, INC. N 20181231 49836-007_1cbf15de-0a67-4fb7-af28-cbcb3db6c6cb 49836-007 HUMAN PRESCRIPTION DRUG P-Care K80MX Triamcinolone Acetonide, Bupivacaine HCl, Lidocaine HCl, Sodium Chloride, Povidone Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA014901 RX PHARMA-PACK, INC. N 20181231 49836-008_684e41d3-6e1a-475e-8016-aa46e9795ea0 49836-008 HUMAN PRESCRIPTION DRUG P-Care K80 Triamcinolone Acetonide, Povidone Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA014901 RX PHARMA-PACK, INC. N 20181231 49836-009_bf181754-cb9f-4878-9917-47297356ce6a 49836-009 HUMAN PRESCRIPTION DRUG P-Care K80G Triamcinolone Acetonide, Povidone-Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA014901 RX PHARMA-PACK, INC. N 20181231 49836-010_a9964323-f050-4520-8981-d4e36ee61c63 49836-010 HUMAN PRESCRIPTION DRUG P-Care D40MX Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HCl KIT 20170616 NDA NDA011757 RX PHARMA-PACK, INC. N 20181231 49836-011_9ab9963a-267a-4ec4-aa73-0ca72ad1fd23 49836-011 HUMAN PRESCRIPTION DRUG P-Care D40 Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA011757 RX PHARMA-PACK, INC. N 20181231 49836-012_f62b1d5a-7e88-4c2c-a5d9-85d74a2340f7 49836-012 HUMAN PRESCRIPTION DRUG P-Care D40G Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA011757 RX PHARMA-PACK, INC. N 20181231 49836-013_b488dff7-3a44-478e-a2cb-5a644cd2cbf2 49836-013 HUMAN PRESCRIPTION DRUG P-Care D80MX Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HCl KIT 20170616 NDA NDA011757 RX PHARMA-PACK, INC. N 20181231 49836-014_c05a01e6-aeae-4606-9935-9fe2ec819060 49836-014 HUMAN PRESCRIPTION DRUG P-Care D80 Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA011757 RX PHARMA-PACK, INC. N 20181231 49836-015_0f82b3fc-0559-4c58-a8a4-90c904a5c85f 49836-015 HUMAN PRESCRIPTION DRUG P-Care D80G Methylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA011757 RX PHARMA-PACK, INC. N 20181231 49836-016_79da1cc4-88fd-45fb-8909-f8f5849c587a 49836-016 HUMAN PRESCRIPTION DRUG D-Care 100X Lidocaine Hydrochloride, Povidone-Iodine, Isopropyl Alcohol KIT 20170616 NDA NDA006488 RX PHARMA-PACK, INC. N 20181231 49836-023_63784189-9bcb-427d-8a60-e780c7c69bd0 49836-023 HUMAN PRESCRIPTION DRUG Anesthesia S/I-50 PROPOFOL ,ISOPROPYL ALCOHOL KIT 20170616 NDA NDA019627 RX PHARMA-PACK, INC. N 20181231 49836-024_24ad940e-0b03-4f26-aeee-68173969c331 49836-024 HUMAN PRESCRIPTION DRUG Anesthesia S/I-60 Propofol, Sterile Isopropyl Alcohol KIT 20170616 NDA NDA019627 RX PHARMA-PACK, INC. N 20181231 49836-025_a1900f3d-0201-46f4-8594-c9d4ba27be76 49836-025 HUMAN PRESCRIPTION DRUG Anesthesia S/I-40 Propofol, Isopropyl Alcohol KIT 20170824 NDA NDA019627 RX PHARMA-PACK, INC. N 20181231 49836-524_411d6009-8720-4017-88d1-bf023c11c070 49836-524 HUMAN PRESCRIPTION DRUG JTT Physicians Joint, Tunnel and Trigger triamcinolone acetonide,lidocaine hydrochloride, povidone iodine, ammonia KIT 20151026 20180331 NDA NDA014901 RX PHARMA-PACK, INC. N 20181231 49836-527_c410323e-e3e6-47fa-8d53-47752f98075b 49836-527 HUMAN PRESCRIPTION DRUG B-12 Compliance Cyanocobalamin, Isopropyl Alcohol KIT 20151023 ANDA ANDA080737 RX PHARMA-PACK, INC. N 20181231 49836-740_7ad17e6d-7b53-4c33-8e20-fd7dd8f619e4 49836-740 HUMAN PRESCRIPTION DRUG MLP A-1 Bupivacaine Hydrochloride, Lidocaine Hydrochloride, Triamcinolone Acetonide, and Povidone-Iodine KIT 20090601 NDA NDA014901 RX PHARMA-PACK, INC. E 20171231 49839-100_434e0805-2e13-4bd4-8764-6c7da5a2c890 49839-100 HUMAN OTC DRUG BACTEX Antiseptic Hand Sanitizer ALCOHOL GEL TOPICAL 20091101 OTC MONOGRAPH FINAL part333 Punto Rojo, S.A ALCOHOL 62 mL/100mL E 20171231 49839-200_8768191f-d306-4348-b7f1-e878c8c3ead0 49839-200 HUMAN OTC DRUG BACTEX Antiseptic Hand Sanitizer ALCOHOL GEL TOPICAL 20091101 OTC MONOGRAPH FINAL part333 Punto Rojo, S.A ALCOHOL 62 mL/100mL E 20171231 49839-300_447cba3b-bfdf-4193-9e67-d406a35835ec 49839-300 HUMAN OTC DRUG BACTEX Antiseptic Hand Sanitizer ALCOHOL GEL TOPICAL 20091101 OTC MONOGRAPH FINAL part333 Punto Rojo, S.A ALCOHOL 62 mL/100mL E 20171231 49852-001_c7a26701-cc9a-4065-b961-d4a9f7ceb949 49852-001 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20100107 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 65 mL/100mL N 20181231 49852-002_7429805f-2ccf-4940-884d-bd11dd632241 49852-002 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-003_9b976d12-431c-4b3b-aaf0-475859bae24d 49852-003 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 65 mL/100mL E 20171231 49852-004_49cc533f-5b9b-450e-b7ce-6ac0b9c63064 49852-004 HUMAN OTC DRUG moisturizing anti-bacterial hand soap TRICLOSAN LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL N 20181231 49852-005_6f3355c9-da00-43be-8ff1-595aaa147407 49852-005 HUMAN OTC DRUG anti-bacterial foaming TRICLOSAN SOAP TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL N 20181231 49852-006_8543b3b9-cf4c-4fed-9ae2-d9e3f6b2a16f 49852-006 HUMAN OTC DRUG moisturizing anti-bacterial hand soap TRICLOSAN LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL N 20181231 49852-007_7aa82e96-6731-4897-b193-767d1908018a 49852-007 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-009_ac9d7c4c-c4f9-4ac7-a9e9-df3a56c9e36c 49852-009 HUMAN OTC DRUG moisturizing anti-bacterial hand soap TRICLOSAN LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL N 20181231 49852-011_64233e92-5712-4d34-9092-b1ae4ef331f0 49852-011 HUMAN OTC DRUG anti-bacterial foaming TRICLOSAN SOAP TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL N 20181231 49852-012_a2650678-96bf-4b01-ab96-c6dd4be8fb9f 49852-012 HUMAN OTC DRUG anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-013_2e5bfee7-c831-4ae1-9ce8-070b950ca9a9 49852-013 HUMAN OTC DRUG anti-bacterial foaming TRICLOSAN SOAP TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL N 20181231 49852-014_db1ededd-fe07-4e94-bfed-0a0e92924bd1 49852-014 HUMAN OTC DRUG moisturizing anti-bacterial hand soap TRICLOSAN LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL N 20181231 49852-015_91c7dcb7-fa0e-426b-9872-ed5b2375b2d7 49852-015 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-016_bcfcf47e-e76a-4e98-8820-675839f5c4ad 49852-016 HUMAN OTC DRUG anti-bacterial foaming TRICLOSAN SOAP TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL N 20181231 49852-017_08468bea-d3a0-4652-92d3-0b6243c03517 49852-017 HUMAN OTC DRUG anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-025_34b5a5ce-990e-1525-e054-00144ff8d46c 49852-025 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333E Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-026_34b70efb-80d1-5160-e054-00144ff8d46c 49852-026 HUMAN OTC DRUG claires BEyouTIFUL hand sanitizer Alcohol LIQUID TOPICAL 20160606 OTC MONOGRAPH NOT FINAL part333E Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-030_231f30b1-303f-4a81-9d29-def719081a38 49852-030 HUMAN OTC DRUG waterless anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 63 mL/100mL N 20181231 49852-031_d5e31d2d-e313-42b5-a5d8-2847f33d5f82 49852-031 HUMAN OTC DRUG waterless anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 63 mL/100mL N 20181231 49852-032_5bea66de-2f5f-4d59-93fd-0dacfd727e94 49852-032 HUMAN OTC DRUG waterless anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 63 mL/100mL N 20181231 49852-033_8128c495-e0cf-40bd-b0b1-b70e04fc752e 49852-033 HUMAN OTC DRUG waterless anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 63 mL/100mL N 20181231 49852-034_ffd4f2fb-6eb9-432e-8eba-435800bcd131 49852-034 HUMAN OTC DRUG waterless anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 63 mL/100mL N 20181231 49852-069_0ce6c9e2-bd8f-4d97-916b-19972ea5f383 49852-069 HUMAN OTC DRUG anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-160_589503f4-50c9-4b36-8962-24600cf5e53e 49852-160 HUMAN OTC DRUG anti bacterial hand sanitizer Ethyl Alcohol LIQUID TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-161_4f2d07b2-357b-43a0-93e5-65d572306112 49852-161 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091211 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-162_2d039dd6-6bb3-47be-9bf1-7c5fe93aa52c 49852-162 HUMAN OTC DRUG moisturizing anti-bacterial hand soap TRICLOSAN LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL N 20181231 49852-163_5f2de8ed-41ac-49ee-a468-d76081fa9897 49852-163 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-164_c5a42019-22ec-40c3-b2af-b4b63bbf9f1c 49852-164 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-165_7c2e405f-6c9d-4816-b8e2-b9eab149c0ad 49852-165 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-166_328ecc4e-767e-4272-bda1-498e5e40fba9 49852-166 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-169_3c185938-b1ad-4ea3-b918-55361c93d992 49852-169 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20091211 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. ALCOHOL 62 mL/100mL N 20181231 49852-170_492a78af-6ee7-40d8-8d59-1003ac073397 49852-170 HUMAN OTC DRUG moisturizing anti-bacterial hand soap TRICLOSAN LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Tri-Coastal Design Company Inc. TRICLOSAN .1 mL/100mL N 20181231 49852-171_f26c0e48-35a9-4531-afd5-126befde1dff 49852-171 HUMAN OTC DRUG simple pleasures antibacterial foaming hand TRICLOSAN SOAP TOPICAL 20121021 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .3 g/100mL N 20181231 49852-172_9c04c602-a1ca-4039-a187-c7914add7948 49852-172 HUMAN OTC DRUG simple pleasures antibacterial foaming hand TRICLOSAN SOAP TOPICAL 20121021 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .3 g/100mL N 20181231 49852-173_d217f066-4ad6-4ba0-884d-b9549f782da4 49852-173 HUMAN OTC DRUG simple pleasures antibacterial foaming hand TRICLOSAN SOAP TOPICAL 20121021 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .3 g/100mL N 20181231 49852-174_6d5f4441-6153-486a-bb8e-aa8d8c61a8ea 49852-174 HUMAN OTC DRUG simple pleasures antibacterial hand TRICLOSAN SOAP TOPICAL 20121021 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .3 g/100mL N 20181231 49852-175_fb27bfbc-db30-4d3c-be2c-81ba22bfe41f 49852-175 HUMAN OTC DRUG simple pleasures antibacterial foaming hand TRICLOSAN SOAP TOPICAL 20121021 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .3 g/100mL N 20181231 49852-176_79f963e9-4e4a-4bd5-878e-137ac7af66f1 49852-176 HUMAN OTC DRUG simple pleasures antibacterial foaming hand TRICLOSAN SOAP TOPICAL 20121021 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. TRICLOSAN .3 g/100mL N 20181231 49852-180_5b683090-237e-42c4-b896-a8deb84c1a59 49852-180 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Alcohol LIQUID TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL N 20181231 49852-181_3fcf0266-213e-434e-9e3a-a05203363331 49852-181 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Alcohol LIQUID TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL N 20181231 49852-182_213951ec-9e15-4068-8ee7-249156263a44 49852-182 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Alcohol LIQUID TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL N 20181231 49852-183_7eb205ad-358b-43a2-9386-ab2b89cce6e6 49852-183 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Alcohol LIQUID TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL N 20181231 49852-184_2125cce3-df11-4702-8c36-9de57a201667 49852-184 HUMAN OTC DRUG Waterless Anti-Bacterial Hand Cleanser Alcohol LIQUID TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL N 20181231 49852-200_22f42874-2f04-45b9-9199-9b9e025974d1 49852-200 HUMAN OTC DRUG Suntan Lotion OCTINOXATE OXYBENZONE TITANIUM DIOXIDE LOTION TOPICAL 20100228 OTC MONOGRAPH FINAL part352 Tri-Coastal Design Company Inc. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 6; 1 mL/100mL; mL/100mL; mL/100mL N 20181231 49852-201_45b4245a-efad-4b1d-b924-fe5fdf36bbc6 49852-201 HUMAN OTC DRUG Suntan Lotion OCTINOXATE OXYBENZONE TITANIUM DIOXIDE LOTION TOPICAL 20100228 OTC MONOGRAPH FINAL part352 Tri-Coastal Design Company Inc. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 6; 1 mL/100mL; mL/100mL; mL/100mL N 20181231 49852-202_f5b7726a-b83a-4df8-8642-d56ec01793c4 49852-202 HUMAN OTC DRUG Lip Balm OCTINOXATE OXYBENZONE DIMETHICONE LIPSTICK TOPICAL 20100228 OTC MONOGRAPH FINAL part352 Tri-Coastal Design Company Inc. OCTINOXATE; OXYBENZONE; DIMETHICONE 6; 6; 6 g/100g; g/100g; g/100g N 20181231 49852-300_5fb33fba-4682-5f01-e053-2991aa0a8d89 49852-300 HUMAN OTC DRUG anti-bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL N 20181231 49852-301_61c20cf5-536d-be22-e053-2a91aa0abbf7 49852-301 HUMAN OTC DRUG anti-bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL N 20191231 49852-302_5fb35246-b48f-7ef2-e053-2991aa0ab860 49852-302 HUMAN OTC DRUG anti-bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL N 20181231 49852-303_5fb37926-9af5-8eee-e053-2a91aa0a7bc7 49852-303 HUMAN OTC DRUG anti-bacterial Hand Cleanser Ethyl Alcohol LIQUID TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL N 20181231 49852-304_5fb30b45-8d6b-4867-e053-2a91aa0a91b2 49852-304 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER Ethyl Alcohol LIQUID TOPICAL 20160509 OTC MONOGRAPH NOT FINAL part333A Tri-Coastal Design Company Inc. ALCOHOL 62 g/100mL N 20181231 49854-001_0be88133-4808-4bb2-8859-9229ca7f30d5 49854-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870101 UNAPPROVED MEDICAL GAS Seeley Enterprises Inc OXYGEN 999 mL/L E 20171231 49869-002_a238b922-010a-40fb-8ee8-da3a82c376c4 49869-002 HUMAN OTC DRUG Avitears polysorbate 80 SOLUTION/ DROPS TOPICAL 20090717 OTC MONOGRAPH FINAL part349 Pinnacle Science, LLc POLYSORBATE 80 10 mg/mL E 20171231 49873-018_e94904cf-d0b5-4a35-a1ba-11954b50223e 49873-018 HUMAN OTC DRUG Satohap dl-camphor, l-menthol, methyl salicylate PATCH TOPICAL 19891108 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 5; 4; 8 mg/1; mg/1; mg/1 N 20181231 49873-019_ededce60-9749-44c0-9b7c-31a0c8072bd0 49873-019 HUMAN OTC DRUG KEEPAN A benzalkonium chloride, lidocaine hydrochloride SPRAY TOPICAL 19810715 OTC MONOGRAPH NOT FINAL part333A Sato Pharmaceutical Co., Ltd. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .1; 1 g/100mL; g/100mL N 20181231 49873-020_22f2f38e-1e71-4c5f-b977-83aa914a6ed4 49873-020 HUMAN OTC DRUG Dorama-Neo water LIQUID OPHTHALMIC 19831108 OTC MONOGRAPH FINAL part349 Sato Pharmaceutical Co., Ltd. WATER 98.4 mL/100mL N 20181231 49873-044_d6810599-b9b2-486b-bba1-a2a77ada3636 49873-044 HUMAN OTC DRUG Sato Clear NAPHAZOLINE HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 19890531 OTC MONOGRAPH FINAL part349 Sato Pharmaceutical Co., Ltd. NAPHAZOLINE HYDROCHLORIDE 12 mg/100mL N 20181231 49873-045_55d0ad13-a37a-4366-b461-1d35195c1f93 49873-045 HUMAN OTC DRUG INON aluminum hydroxide, magnesium carbonate, sodium bicarbonate GRANULE ORAL 19890531 OTC MONOGRAPH FINAL part331 Sato Pharmaceutical Co., Ltd. ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE; SODIUM BICARBONATE 400; 400; 700 mg/1.92g; mg/1.92g; mg/1.92g N 20181231 49873-050_7214f42c-c4c9-4aca-a3c1-507d376d2068 49873-050 HUMAN OTC DRUG Hi Vetic tolnaftate SOLUTION TOPICAL 19900814 OTC MONOGRAPH FINAL part333C Sato Pharmaceutical Co., Ltd. TOLNAFTATE 1 g/100mL N 20181231 49873-056_7b7ea288-3a83-444e-9763-2c14f33e5997 49873-056 HUMAN OTC DRUG Hi Vetic tolnaftate OINTMENT TOPICAL 19961025 OTC MONOGRAPH FINAL part333C Sato Pharmaceutical Co., Ltd. TOLNAFTATE 1 g/100g N 20181231 49873-057_7750c714-3e28-4951-a0ea-b8521d6ec2a0 49873-057 HUMAN OTC DRUG Nazal Naphazoline hydrochloride LIQUID NASAL 19900611 OTC MONOGRAPH NOT FINAL part341 Sato Pharmaceutical Co., Ltd. NAPHAZOLINE HYDROCHLORIDE 50 mg/100mL N 20181231 49873-060_262d37c0-19a5-472b-a270-7f36cd8145cf 49873-060 HUMAN OTC DRUG Satogesic dl-camphor, l-menthol, methyl salicylate PATCH TOPICAL 19901203 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 5; 4; 8 mg/1; mg/1; mg/1 N 20181231 49873-065_b20010de-daf7-4aa7-8304-5ed83dc7a9c9 49873-065 HUMAN OTC DRUG Satohap methyl salicylate, dl-camphor, l-menthol LOTION TOPICAL 19910205 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. METHYL SALICYLATE; CAMPHOR (SYNTHETIC); LEVOMENTHOL 10; 5; 4 g/100mL; g/100mL; g/100mL N 20181231 49873-067_1a6b231c-2752-4172-bdb4-4ef51fe2739d 49873-067 HUMAN OTC DRUG Satogesic dl-camphor, l-menthol, methyl salicylate SPRAY TOPICAL 19911125 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 5; 4; 10 g/100mL; g/100mL; g/100mL N 20181231 49873-068_e1cbbc3f-da84-4b43-9caf-de6e04ddd5a1 49873-068 HUMAN OTC DRUG Satohap methyl salicylate, dl-camphor, l-menthol SPRAY TOPICAL 20061109 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. METHYL SALICYLATE; CAMPHOR (SYNTHETIC); LEVOMENTHOL 10; 5; 4 g/100mL; g/100mL; g/100mL N 20181231 49873-078_e89ccd89-1018-4b67-9d64-e54dab6ddf40 49873-078 HUMAN OTC DRUG Satos Corn and Callus Remover salicylic acid LIQUID TOPICAL 19870919 OTC MONOGRAPH FINAL part358F Sato Pharmaceutical Co., Ltd. SALICYLIC ACID 12 g/100mL N 20181231 49873-082_092cb41d-b085-4263-9685-9b4b9a70691a 49873-082 HUMAN OTC DRUG Ringl acetaminophen TABLET ORAL 19960509 OTC MONOGRAPH NOT FINAL part343 Sato Pharmaceutical Co., Ltd. ACETAMINOPHEN 325 mg/1 N 20181231 49873-108_9306d00a-280d-4da5-8484-8695e32f7207 49873-108 HUMAN OTC DRUG Stona for Children acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide SYRUP ORAL 20010103 OTC MONOGRAPH FINAL part341 Sato Pharmaceutical Co., Ltd. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 325; 2; 10 mg/15mL; mg/15mL; mg/15mL N 20181231 49873-109_630430bf-675f-4165-abf9-17abcd738464 49873-109 HUMAN OTC DRUG Stonarhini Chlorpheniramine maleate, phenylephrine TABLET ORAL 20011116 OTC MONOGRAPH FINAL part341 Sato Pharmaceutical Co., Ltd. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/1; mg/1 N 20181231 49873-113_02227437-a9e9-4f21-b382-11a263594553 49873-113 HUMAN OTC DRUG Stona-S acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride CAPSULE ORAL 20040927 OTC MONOGRAPH FINAL part341 Sato Pharmaceutical Co., Ltd. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 162.5; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49873-114_43202695-5e1e-4d0f-887c-4df5b40fbd3b 49873-114 HUMAN OTC DRUG Stona acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride TABLET ORAL 20040929 OTC MONOGRAPH FINAL part341 Sato Pharmaceutical Co., Ltd. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 162.5; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 49873-301_ab10a7df-15de-4d89-8f7b-661520fc2b0f 49873-301 HUMAN OTC DRUG Stona Troche dextromethorphan hydrobromide LOZENGE ORAL 19951119 OTC MONOGRAPH NOT FINAL part341 Sato Pharmaceutical Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 N 20181231 49873-302_2f28c7bd-ca49-4d95-970e-6bbc06d38a45 49873-302 HUMAN OTC DRUG Stona Cough dextromethorphan hydrobromide, guaifenesin SYRUP ORAL 20010103 OTC MONOGRAPH FINAL part341 Sato Pharmaceutical Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30; 200 mg/10mL; mg/10mL N 20181231 49873-306_7a0a91e3-c25e-40a9-8e43-13afc350baaf 49873-306 HUMAN OTC DRUG Stona Cough dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride TABLET ORAL 20041124 OTC MONOGRAPH FINAL part341 Sato Pharmaceutical Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 100; 5 mg/1; mg/1; mg/1 N 20181231 49873-401_a32f01b5-42f2-4dad-b87e-587b22e13d9f 49873-401 HUMAN OTC DRUG MINICA-S glycerin ENEMA RECTAL 19940501 OTC MONOGRAPH NOT FINAL part334 Sato Pharmaceutical Co., Ltd. GLYCERIN 80 mL/100mL N 20181231 49873-402_e5a5bd2b-a8ff-436f-b95b-cd5cc6367728 49873-402 HUMAN OTC DRUG Inon Ace magnesium aluminosilicates, magnesium hydroxide, simethicone TABLET ORAL 19951101 OTC MONOGRAPH FINAL part331 Sato Pharmaceutical Co., Ltd. MAGNESIUM HYDROXIDE; SILODRATE; DIMETHICONE 60; 200; 20 mg/1; mg/1; mg/1 N 20181231 49873-403_e0e2e5d4-704c-41cd-8d19-545bc77d5dbd 49873-403 HUMAN OTC DRUG Inon Ace magnesium aluminosilicate, magnesium hydroxide SOLUTION ORAL 20000520 OTC MONOGRAPH FINAL part331 Sato Pharmaceutical Co., Ltd. SILODRATE; MAGNESIUM HYDROXIDE 900; 250 mg/30mL; mg/30mL N 20181231 49873-404_3e306e24-1bcf-44bc-b2dd-5abbef95b298 49873-404 HUMAN OTC DRUG Sankaijo docusate sodium, sennosides TABLET ORAL 20021220 OTC MONOGRAPH NOT FINAL part334 Sato Pharmaceutical Co., Ltd. DOCUSATE SODIUM; SENNOSIDES 8.33; 1.36 mg/1; mg/1 N 20181231 49873-501_3639b8df-0b0f-4f36-bd3c-73f222b71b53 49873-501 HUMAN OTC DRUG Optic Splash naphazoline hydrochloride, glycerin SOLUTION/ DROPS OPHTHALMIC 20080122 OTC MONOGRAPH FINAL part349 Sato Pharmaceutical, Co., Ltd. NAPHAZOLINE HYDROCHLORIDE; GLYCERIN 20; 200 mg/100mL; mg/100mL N 20181231 49873-608_bc960609-8e02-49c7-ab99-95fd84b3783f 49873-608 HUMAN OTC DRUG Satogesic Hot capsaicin PATCH TOPICAL 20061122 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. CAPSAICIN .25 mg/1 N 20181231 49873-703_d6d1a3ec-2c2a-4823-bd1b-d495542f1ec3 49873-703 HUMAN OTC DRUG Poli-A hydrocortisone acetate OINTMENT TOPICAL 19950319 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. HYDROCORTISONE ACETATE 1 g/100g N 20181231 49873-704_a0e6cca1-cad5-4622-8735-04e0239a1abd 49873-704 HUMAN OTC DRUG Tact Cool Jelly diphenhydramine hydrochloride, levomenthol GEL TOPICAL 19971002 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Co., Ltd. DIPHENHYDRAMINE HYDROCHLORIDE; LEVOMENTHOL 2; 1 g/100g; g/100g N 20181231 49873-705_f88439ae-d9ee-45e7-aae1-165c4bbf2cc8 49873-705 HUMAN OTC DRUG TACT diphenhydramine hydrochloride, menthol CREAM TOPICAL 19970909 OTC MONOGRAPH NOT FINAL part348 Sato Pharmaceutical Inc., Ltd. DIPHENHYDRAMINE HYDROCHLORIDE; LEVOMENTHOL 2; 1 g/100g; g/100g N 20181231 49873-802_165c3555-b0bf-4b7a-9beb-bb8960f6829a 49873-802 HUMAN OTC DRUG Airmit Ace dimenhydrinate TABLET ORAL 20050311 OTC MONOGRAPH FINAL part336 Sato Pharmaceutical Co., Ltd. DIMENHYDRINATE 25 mg/1 N 20181231 49873-803_cff56526-56de-4a8f-a5a5-b4220e3d8ab8 49873-803 HUMAN OTC DRUG Zentrip meclizine hydrochloride FILM, SOLUBLE ORAL 20090203 OTC MONOGRAPH FINAL part336 Sato Pharmaceutical Co., Ltd. MECLIZINE HYDROCHLORIDE 25 mg/1 E 20171231 49877-006_5dc51c6f-3311-4bef-8a88-3e825d205777 49877-006 HUMAN OTC DRUG Goldlove Hand Sanitizer None Hand Sanitizer LIQUID TOPICAL 20091110 OTC MONOGRAPH FINAL part333 Cixi Zhixin Bird Clean-care Product Co., Ltd. ALCOHOL 62 g/100g E 20171231 49877-011_cc0e831d-9fa0-402c-9118-393376e65734 49877-011 HUMAN OTC DRUG Ultracruz Antibacterial None BENZALKONIUM CHLORIDE LOTION TOPICAL 20140822 OTC MONOGRAPH NOT FINAL part333A Cixi Zhixin Bird Clean-care Product Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 49877-012_b163da89-3588-4aac-8c97-1e2af1479ef7 49877-012 HUMAN OTC DRUG Ultracruz Antibacterial Hand None BENZALKONIUM CHLORIDE SOAP TOPICAL 20140822 OTC MONOGRAPH NOT FINAL part333A Cixi Zhixin Bird Clean-care Product Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 49882-0929_1519f7e2-94da-4e60-a317-617bbcce4794 49882-0929 HUMAN OTC DRUG SKILCRAFT Anti-bacterial Wipes SKILCRAFT Anti-bacterial Wipes CLOTH TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Winston Salem Industries for the Blind, Inc. BENZALKONIUM CHLORIDE; BENZETHONIUM CHLORIDE .1; .1 g/970mL; g/970mL E 20171231 49884-006_4584c707-7c10-4c8d-8ed9-693cc576ac97 49884-006 HUMAN PRESCRIPTION DRUG Sodium Phenylbutyrate Sodium Phenylbutyrate POWDER ORAL 20160831 ANDA ANDA203918 Par Pharmaceutical, Inc. SODIUM PHENYLBUTYRATE .94 g/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 49884-007_4479e5ce-016a-4b18-a1c0-224fca0fa28f 49884-007 HUMAN PRESCRIPTION DRUG Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg Aspirin and Extended - Release Dipyridamole CAPSULE ORAL 20170130 ANDA ANDA207944 Par Pharmaceutical, Inc. ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 49884-009_c155c11f-7c5d-4316-98ef-641e8badbd1f 49884-009 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19830210 ANDA ANDA087946 Par Pharmaceutical Inc. ISOSORBIDE DINITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 49884-010_47ad879f-77c0-4955-a5a1-783aaa19d59f 49884-010 HUMAN PRESCRIPTION DRUG ACCOLATE zafirlukast TABLET, FILM COATED ORAL 20150109 NDA NDA020547 Par Pharmaceutical Inc. ZAFIRLUKAST 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 49884-011_47ad879f-77c0-4955-a5a1-783aaa19d59f 49884-011 HUMAN PRESCRIPTION DRUG ACCOLATE zafirlukast TABLET, FILM COATED ORAL 20150109 NDA NDA020547 Par Pharmaceutical Inc. ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 49884-019_4e277407-8a23-4615-9683-4831c97bfab6 49884-019 HUMAN PRESCRIPTION DRUG Omega-3-Acid Ethyl Esters omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20140630 ANDA ANDA091018 Par Pharmaceutical, Inc. OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 49884-020_c155c11f-7c5d-4316-98ef-641e8badbd1f 49884-020 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19791213 ANDA ANDA086923 Par Pharmaceutical Inc. ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 49884-021_c155c11f-7c5d-4316-98ef-641e8badbd1f 49884-021 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19791222 ANDA ANDA086925 Par Pharmaceutical Inc. ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 49884-022_c155c11f-7c5d-4316-98ef-641e8badbd1f 49884-022 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19811215 ANDA ANDA087537 Par Pharmaceutical Inc. ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 49884-027_7de33596-55b5-4e3d-905e-9dfc8f72932c 49884-027 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19800227 20180430 ANDA ANDA086961 Par Pharmaceutical, Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 49884-028_7de33596-55b5-4e3d-905e-9dfc8f72932c 49884-028 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19800227 20180430 ANDA ANDA086962 Par Pharmaceutical, Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 49884-029_7de33596-55b5-4e3d-905e-9dfc8f72932c 49884-029 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19821005 20180430 ANDA ANDA087836 Par Pharmaceutical, Inc. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 49884-032_d976e22b-8299-4c5d-ae49-be15229b9f04 49884-032 HUMAN PRESCRIPTION DRUG Tranylcypromine Sulfate tranylcypromine sulfate TABLET ORAL 20060630 ANDA ANDA040640 Par Pharmaceutical, Inc. TRANYLCYPROMINE SULFATE 10 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 49884-034_1929e0b0-74b1-4d91-9ff3-f2f82e8ad3f7 49884-034 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087127 Par Pharmaceutical, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 49884-035_1929e0b0-74b1-4d91-9ff3-f2f82e8ad3f7 49884-035 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 Par Pharmaceutical, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 49884-038_18957b76-0baa-495e-8917-03b6fc16d065 49884-038 HUMAN PRESCRIPTION DRUG Phenoxybenzamine Hydrochloride Phenoxybenzamine Hydrochloride CAPSULE ORAL 20170124 ANDA ANDA204522 Par Pharmaceutical, Inc. PHENOXYBENZAMINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 49884-044_dc1371a6-b595-4d77-9f34-46de41d51c86 49884-044 HUMAN PRESCRIPTION DRUG Travoprost Ophthalmic Solution 0.004% travoprost SOLUTION OPHTHALMIC 20130415 20191031 ANDA ANDA091340 Par Pharmaceutical, Inc. TRAVOPROST .04 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] E 20171231 49884-048_416f9913-d186-4ada-a775-aba06dda7db7 49884-048 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170105 ANDA ANDA202842 Par Pharmaceutical, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 49884-049_416f9913-d186-4ada-a775-aba06dda7db7 49884-049 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170105 ANDA ANDA202842 Par Pharmaceutical, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 49884-054_6dde92b0-06d6-4d7d-b342-a5e0e315be8a 49884-054 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19831021 ANDA ANDA088292 Par Pharmaceutical, Inc. IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 49884-055_6dde92b0-06d6-4d7d-b342-a5e0e315be8a 49884-055 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19831021 ANDA ANDA088262 Par Pharmaceutical, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 49884-056_6dde92b0-06d6-4d7d-b342-a5e0e315be8a 49884-056 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19831021 ANDA ANDA088276 Par Pharmaceutical, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 49884-065_b9bf32fd-f345-4f10-aa36-33ed8e7b5fb7 49884-065 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20060926 ANDA ANDA040653 Par Pharmaceutical Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 49884-066_b9bf32fd-f345-4f10-aa36-33ed8e7b5fb7 49884-066 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20060926 ANDA ANDA040653 Par Pharmaceutical Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 49884-084_ef69689b-d06c-4784-80c8-8226e6bd2e64 49884-084 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088148 Par Pharmaceutical Inc. DEXAMETHASONE .5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49884-085_ef69689b-d06c-4784-80c8-8226e6bd2e64 49884-085 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088160 Par Pharmaceutical Inc. DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49884-086_ef69689b-d06c-4784-80c8-8226e6bd2e64 49884-086 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088237 Par Pharmaceutical Inc. DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49884-087_ef69689b-d06c-4784-80c8-8226e6bd2e64 49884-087 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088238 Par Pharmaceutical Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49884-090_416f9913-d186-4ada-a775-aba06dda7db7 49884-090 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170105 ANDA ANDA202842 Par Pharmaceutical, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 49884-091_604db7b7-6aa7-4576-a35f-768ba9c53004 49884-091 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline TABLET ORAL 20001215 20200331 ANDA ANDA065070 Par Pharmaceutical, Inc. DOXYCYCLINE 50 mg/1 N 20181231 49884-092_604db7b7-6aa7-4576-a35f-768ba9c53004 49884-092 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline TABLET ORAL 20001215 20200331 ANDA ANDA065070 Par Pharmaceutical, Inc. DOXYCYCLINE 75 mg/1 N 20181231 49884-093_604db7b7-6aa7-4576-a35f-768ba9c53004 49884-093 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline TABLET ORAL 20001215 20200831 ANDA ANDA065070 Par Pharmaceutical, Inc. DOXYCYCLINE 100 mg/1 N 20181231 49884-096_3bb7df02-5222-4765-b0ba-2a7c8f41e98d 49884-096 HUMAN PRESCRIPTION DRUG DYNACIN Minocycline Hydrochloride TABLET ORAL 20110620 ANDA ANDA065131 Par Pharmaceutical, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 49884-097_3bb7df02-5222-4765-b0ba-2a7c8f41e98d 49884-097 HUMAN PRESCRIPTION DRUG DYNACIN Minocycline Hydrochloride TABLET ORAL 20110620 ANDA ANDA065131 Par Pharmaceutical, Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 49884-098_3bb7df02-5222-4765-b0ba-2a7c8f41e98d 49884-098 HUMAN PRESCRIPTION DRUG DYNACIN Minocycline Hydrochloride TABLET ORAL 20110620 ANDA ANDA065131 Par Pharmaceutical, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 49884-110_1f7b926e-6962-4437-a2ea-02120983631b 49884-110 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20090109 ANDA ANDA078088 Par Pharmaceutical, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49884-111_1f7b926e-6962-4437-a2ea-02120983631b 49884-111 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20090109 ANDA ANDA078088 Par Pharmaceutical, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49884-113_5bf111b8-37c8-4697-868e-5af24fb1d029 49884-113 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110103 ANDA ANDA078540 Par Pharmaceutical, Inc. PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] N 20181231 49884-117_b16f693b-7e1c-40e1-9d1b-b5da7979b7cd 49884-117 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL 19860122 ANDA ANDA070346 Par Pharmaceutical, Inc. AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 49884-121_7de33596-55b5-4e3d-905e-9dfc8f72932c 49884-121 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19830927 20180430 ANDA ANDA088391 Par Pharmaceutical, Inc. HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 49884-122_0807b84f-3844-4e39-884c-92cefa80c408 49884-122 HUMAN PRESCRIPTION DRUG Labetalol HCL Labetalol Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA200908 Par Pharmaceutical, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49884-123_0807b84f-3844-4e39-884c-92cefa80c408 49884-123 HUMAN PRESCRIPTION DRUG Labetalol HCL Labetalol Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA200908 Par Pharmaceutical, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49884-124_0807b84f-3844-4e39-884c-92cefa80c408 49884-124 HUMAN PRESCRIPTION DRUG Labetalol HCL Labetalol Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA200908 Par Pharmaceutical, Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49884-136_1a82d9cc-a636-4838-a50f-ed542fa5cd26 49884-136 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 20201231 NDA AUTHORIZED GENERIC NDA022272 Par Pharmaceutical, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-137_1a82d9cc-a636-4838-a50f-ed542fa5cd26 49884-137 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 20201231 NDA AUTHORIZED GENERIC NDA022272 Par Pharmaceutical, Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-138_1a82d9cc-a636-4838-a50f-ed542fa5cd26 49884-138 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 20201231 NDA AUTHORIZED GENERIC NDA022272 Par Pharmaceutical, Inc. OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-161_b7b5a9b3-bc6e-4c91-a18b-e08abd181a4c 49884-161 HUMAN PRESCRIPTION DRUG CALCITONIN SALMON CALCITONIN SALMON SPRAY, METERED NASAL 20090608 ANDA ANDA076979 Par Pharmaceutical, Inc. CALCITONIN SALMON 200 [iU]/.09mL Calcitonin [Chemical/Ingredient],Calcitonin [EPC] N 20181231 49884-170_682dc4ca-6e05-435d-bc94-708d19acdea8 49884-170 HUMAN PRESCRIPTION DRUG Sodium Phenylbutyrate Sodium Phenylbutyrate Tablets, 500 mg TABLET ORAL 20160429 ANDA ANDA204395 Par Pharmaceutical, Inc. SODIUM PHENYLBUTYRATE 500 mg/1 Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 49884-172_dde88dc7-431f-454e-89ef-56cf5415ad19 49884-172 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine besylate valsartan hydrochlorothiazide TABLET, FILM COATED ORAL 20150601 ANDA ANDA201087 Par Pharmaceutical, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49884-173_dde88dc7-431f-454e-89ef-56cf5415ad19 49884-173 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine besylate valsartan hydrochlorothiazide TABLET, FILM COATED ORAL 20150601 ANDA ANDA201087 Par Pharmaceutical, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49884-174_dde88dc7-431f-454e-89ef-56cf5415ad19 49884-174 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine besylate valsartan hydrochlorothiazide TABLET, FILM COATED ORAL 20150601 ANDA ANDA201087 Par Pharmaceutical, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49884-175_dde88dc7-431f-454e-89ef-56cf5415ad19 49884-175 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine besylate valsartan hydrochlorothiazide TABLET, FILM COATED ORAL 20150601 ANDA ANDA201087 Par Pharmaceutical, Inc. AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10; 25; 320 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 49884-185_dde88dc7-431f-454e-89ef-56cf5415ad19 49884-185 HUMAN PRESCRIPTION DRUG AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE amlodipine besylate valsartan hydrochlorothiazide TABLET, FILM COATED ORAL 20150601 ANDA ANDA201087 Par Pharmaceutical, Inc. AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10; 25; 160 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 49884-197_1a82d9cc-a636-4838-a50f-ed542fa5cd26 49884-197 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 20201231 NDA AUTHORIZED GENERIC NDA022272 Par Pharmaceutical, Inc. OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-204_8b278c49-8e40-4873-b73d-d5a4a3d6ee3a 49884-204 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, EXTENDED RELEASE ORAL 20110913 ANDA ANDA091291 Par Pharmaceutical Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 49884-205_8b278c49-8e40-4873-b73d-d5a4a3d6ee3a 49884-205 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, EXTENDED RELEASE ORAL 20110913 ANDA ANDA091291 Par Pharmaceutical Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 49884-210_5bf111b8-37c8-4697-868e-5af24fb1d029 49884-210 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110103 ANDA ANDA078540 Par Pharmaceutical, Inc. PROPAFENONE HYDROCHLORIDE 325 mg/1 Antiarrhythmic [EPC] N 20181231 49884-211_5bf111b8-37c8-4697-868e-5af24fb1d029 49884-211 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110103 ANDA ANDA078540 Par Pharmaceutical, Inc. PROPAFENONE HYDROCHLORIDE 425 mg/1 Antiarrhythmic [EPC] N 20181231 49884-212_32079395-365a-48a4-99e0-8770a87841ca 49884-212 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090601 ANDA ANDA077494 Par Pharmaceutical, Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-213_1f7b926e-6962-4437-a2ea-02120983631b 49884-213 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20090109 ANDA ANDA078088 Par Pharmaceutical, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49884-214_1f7b926e-6962-4437-a2ea-02120983631b 49884-214 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET, ORALLY DISINTEGRATING ORAL 20090109 ANDA ANDA078088 Par Pharmaceutical, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49884-217_e5c5b6b5-16a4-4542-8e31-e5293c5c8472 49884-217 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20170901 ANDA ANDA071697 Par Pharmaceutical, Inc. DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20191231 49884-218_e5c5b6b5-16a4-4542-8e31-e5293c5c8472 49884-218 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20170901 ANDA ANDA071437 Par Pharmaceutical, Inc. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 49884-219_e5c5b6b5-16a4-4542-8e31-e5293c5c8472 49884-219 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20170901 ANDA ANDA071595 Par Pharmaceutical, Inc. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 49884-220_e5c5b6b5-16a4-4542-8e31-e5293c5c8472 49884-220 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20170901 ANDA ANDA071608 Par Pharmaceutical, Inc. DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20191231 49884-221_e5c5b6b5-16a4-4542-8e31-e5293c5c8472 49884-221 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20170901 ANDA ANDA071422 Par Pharmaceutical, Inc. DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20191231 49884-222_e5c5b6b5-16a4-4542-8e31-e5293c5c8472 49884-222 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19871109 ANDA ANDA071669 Par Pharmaceutical, Inc. DOXEPIN HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20191231 49884-228_fb237f7e-7a4c-4e8b-bdbc-1221b9b1a565 49884-228 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20161212 ANDA ANDA078560 Par Pharmaceutical Inc EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] E 20171231 49884-230_9439c3c2-338a-4d5a-be71-62c71e255504 49884-230 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20150728 NDA AUTHORIZED GENERIC NDA021778 Par Pharmaceutical, Inc. MEGESTROL ACETATE 125 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 49884-232_d9c16907-aec5-47ee-ac40-9102e68b4a1e 49884-232 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET ORAL 20130915 20200731 ANDA ANDA202542 Par Pharmaceutical, Inc. DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 49884-236_604db7b7-6aa7-4576-a35f-768ba9c53004 49884-236 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline TABLET ORAL 20001215 20200630 ANDA ANDA065070 Par Pharmaceutical, Inc. DOXYCYCLINE 150 mg/1 N 20181231 49884-238_d1fb6563-6efb-461a-9e63-faa0eee29720 49884-238 HUMAN PRESCRIPTION DRUG CLARITHROMYCIN CLARITHROMYCIN EXTENDED-RELEASE TABLET ORAL 20160620 ANDA ANDA203243 Par Pharmaceutical, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 49884-239_1ab16de8-4677-4b43-8a7b-c0a8ac7300b1 49884-239 HUMAN PRESCRIPTION DRUG Itraconazole Itraconazole CAPSULE ORAL 20160701 ANDA ANDA205724 Par Pharmaceutical, Inc. ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 49884-248_416f9913-d186-4ada-a775-aba06dda7db7 49884-248 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170105 ANDA ANDA202842 Par Pharmaceutical, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 49884-250_30b65c17-8cd3-4ea4-aa8c-2d0050ef2b4f 49884-250 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine olanzapine and fuoxetine CAPSULE ORAL 20121126 ANDA ANDA077742 Par Pharmaceutical, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 6; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49884-251_30b65c17-8cd3-4ea4-aa8c-2d0050ef2b4f 49884-251 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine olanzapine and fuoxetine CAPSULE ORAL 20121126 ANDA ANDA077742 Par Pharmaceutical, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 6; 50 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49884-252_30b65c17-8cd3-4ea4-aa8c-2d0050ef2b4f 49884-252 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine olanzapine and fuoxetine CAPSULE ORAL 20121126 ANDA ANDA077742 Par Pharmaceutical, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 12; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49884-253_30b65c17-8cd3-4ea4-aa8c-2d0050ef2b4f 49884-253 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine olanzapine and fuoxetine CAPSULE ORAL 20121126 ANDA ANDA077742 Par Pharmaceutical, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 12; 50 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49884-254_d3496441-83fe-4df9-aa8d-5d776fda27bc 49884-254 HUMAN PRESCRIPTION DRUG Tolcapone Tolcapone TABLET, COATED ORAL 20150106 ANDA ANDA204584 Par Pharmaceutical, Inc. TOLCAPONE 100 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 49884-256_39fdf801-c02f-42e0-a4fa-36057178d6bd 49884-256 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 19881114 ANDA ANDA071826 Par Pharmaceutical Inc MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 49884-257_39fdf801-c02f-42e0-a4fa-36057178d6bd 49884-257 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 19881114 ANDA ANDA071839 Par Pharmaceutical Inc MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 49884-258_a06fd81d-a033-4cc3-abff-797d711303ff 49884-258 HUMAN PRESCRIPTION DRUG Metaproterenol Sulfate Metaproterenol Sulfate TABLET ORAL 19880628 ANDA ANDA072024 Par Pharmaceutical, Inc. METAPROTERENOL SULFATE 10 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 49884-259_a06fd81d-a033-4cc3-abff-797d711303ff 49884-259 HUMAN PRESCRIPTION DRUG Metaproterenol Sulfate Metaproterenol Sulfate TABLET ORAL 19880628 ANDA ANDA072025 Par Pharmaceutical, Inc. METAPROTERENOL SULFATE 20 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 49884-260_6c13ce4e-fa54-4a72-9466-bb025c064b76 49884-260 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET ORAL 20160719 20200630 ANDA ANDA079168 Par Pharmaceutical, Inc. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 49884-261_6c13ce4e-fa54-4a72-9466-bb025c064b76 49884-261 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET ORAL 20160719 20200831 ANDA ANDA079168 Par Pharmaceutical, Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 49884-262_6c13ce4e-fa54-4a72-9466-bb025c064b76 49884-262 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET ORAL 20160719 20200831 ANDA ANDA079168 Par Pharmaceutical, Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 49884-263_6c13ce4e-fa54-4a72-9466-bb025c064b76 49884-263 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium rosuvastatin calcium TABLET ORAL 20160719 20200630 ANDA ANDA079168 Par Pharmaceutical, Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 49884-265_aa5d4728-5548-4db0-8d36-4cd70950dabf 49884-265 HUMAN PRESCRIPTION DRUG Chlordiazepoxide and Amitriptyline HCl Chlordiazepoxide and Amitriptyline hydrochloride TABLET ORAL 19880509 ANDA ANDA072277 Par Pharmaceutical Inc CHLORDIAZEPOXIDE; AMITRIPTYLINE HYDROCHLORIDE 5; 12.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] CIV N 20181231 49884-266_aa5d4728-5548-4db0-8d36-4cd70950dabf 49884-266 HUMAN PRESCRIPTION DRUG Chlordiazepoxide and Amitriptyline HCl Chlordiazepoxide and Amitriptyline hydrochloride TABLET ORAL 19880509 ANDA ANDA072278 Par Pharmaceutical Inc CHLORDIAZEPOXIDE; AMITRIPTYLINE HYDROCHLORIDE 10; 25 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Tricyclic Antidepressant [EPC] CIV N 20181231 49884-268_1a997b43-0f4a-48ee-93ab-af54aad32684 49884-268 HUMAN PRESCRIPTION DRUG Omeprazole/Sodium Bicarbonate Omeprazole and Sodium Bicarbonate POWDER, FOR SUSPENSION ORAL 20160718 ANDA ANDA079182 Par Pharmaceutical, Inc. OMEPRAZOLE; SODIUM BICARBONATE 20; 1680 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 49884-269_1a997b43-0f4a-48ee-93ab-af54aad32684 49884-269 HUMAN PRESCRIPTION DRUG Omeprazole/Sodium Bicarbonate Omeprazole and Sodium Bicarbonate POWDER, FOR SUSPENSION ORAL 20160718 ANDA ANDA079182 Par Pharmaceutical, Inc. OMEPRAZOLE; SODIUM BICARBONATE 40; 1680 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 49884-270_57e60d83-dac0-4748-bec5-485690f1eea4 49884-270 HUMAN PRESCRIPTION DRUG Nascobal cyanocobalamin SPRAY NASAL 20090813 NDA NDA021642 Par Pharmaceutical , Inc CYANOCOBALAMIN 500 ug/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 49884-270_f8743deb-4616-4327-9d16-cb454505bc65 49884-270 HUMAN PRESCRIPTION DRUG Nascobal cyanocobalamin SPRAY NASAL 20090813 NDA NDA021642 Par Pharmaceutical , Inc CYANOCOBALAMIN 500 ug/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 49884-276_f8bc298e-6564-42a7-84b3-81539f3519b1 49884-276 HUMAN PRESCRIPTION DRUG Ethacrynic Acid Ethacrynic Acid TABLET ORAL 20170721 ANDA ANDA208501 Par Pharmaceutical, Inc. ETHACRYNIC ACID 25 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 49884-277_30b65c17-8cd3-4ea4-aa8c-2d0050ef2b4f 49884-277 HUMAN PRESCRIPTION DRUG Olanzapine and Fluoxetine olanzapine and fuoxetine CAPSULE ORAL 20121126 ANDA ANDA077742 Par Pharmaceutical, Inc. OLANZAPINE; FLUOXETINE HYDROCHLORIDE 3; 25 mg/1; mg/1 Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49884-289_238cfa3a-01b2-4b94-8274-a1a00ecdc9ff 49884-289 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19880808 ANDA ANDA072422 Par Pharmaceutical, Inc. MEGESTROL ACETATE 20 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 49884-290_238cfa3a-01b2-4b94-8274-a1a00ecdc9ff 49884-290 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19880808 ANDA ANDA072423 Par Pharmaceutical, Inc. MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 49884-301_b6abfdb5-35c6-4551-9af6-fc9ba287b310 49884-301 HUMAN PRESCRIPTION DRUG Oxandrolone oxandrolone TABLET ORAL 20070820 ANDA ANDA077827 Par Pharmaceutical, Inc. OXANDROLONE 2.5 mg/1 CIII N 20181231 49884-302_b6abfdb5-35c6-4551-9af6-fc9ba287b310 49884-302 HUMAN PRESCRIPTION DRUG Oxandrolone oxandrolone TABLET ORAL 20070820 ANDA ANDA077827 Par Pharmaceutical, Inc. OXANDROLONE 10 mg/1 CIII N 20181231 49884-304_0e2c3d04-10d8-4b5f-b702-a697d4a21076 49884-304 HUMAN PRESCRIPTION DRUG ZAFIRLUKAST Zafirlukast TABLET, FILM COATED ORAL 20101201 20180228 NDA NDA020547 Par Pharmaceutical Inc. ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 49884-305_e0c4cd47-bf67-48de-b28e-201628fbf312 49884-305 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20110601 ANDA ANDA065055 Par Pharmaceutical, Inc. DOXYCYCLINE 150 mg/1 N 20191231 49884-306_a61c5e39-45ea-4a49-b3d0-2013369d7983 49884-306 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050805 ANDA ANDA077171 Par Pharmaceutical, Inc. CLONAZEPAM .125 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49884-307_a61c5e39-45ea-4a49-b3d0-2013369d7983 49884-307 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050805 ANDA ANDA077171 Par Pharmaceutical, Inc. CLONAZEPAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49884-308_a61c5e39-45ea-4a49-b3d0-2013369d7983 49884-308 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050805 ANDA ANDA077171 Par Pharmaceutical, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49884-309_a61c5e39-45ea-4a49-b3d0-2013369d7983 49884-309 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050805 ANDA ANDA077171 Par Pharmaceutical, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49884-310_a61c5e39-45ea-4a49-b3d0-2013369d7983 49884-310 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20050805 ANDA ANDA077171 Par Pharmaceutical, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49884-311_32079395-365a-48a4-99e0-8770a87841ca 49884-311 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090601 ANDA ANDA077494 Par Pharmaceutical, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-315_32079395-365a-48a4-99e0-8770a87841ca 49884-315 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091026 ANDA ANDA077494 Par Pharmaceutical, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-320_9312a278-16cd-4994-a4f2-f1299f4a15d8 49884-320 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA078109 Par Pharmaceutical, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-321_9312a278-16cd-4994-a4f2-f1299f4a15d8 49884-321 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA078109 Par Pharmaceutical, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-322_9312a278-16cd-4994-a4f2-f1299f4a15d8 49884-322 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA078109 Par Pharmaceutical, Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-323_9312a278-16cd-4994-a4f2-f1299f4a15d8 49884-323 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA078109 Par Pharmaceutical, Inc. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-333_416f9913-d186-4ada-a775-aba06dda7db7 49884-333 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170105 ANDA ANDA202842 Par Pharmaceutical, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 25 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 49884-335_5cdceb12-d10a-45e9-8115-e44e709b3fa3 49884-335 HUMAN PRESCRIPTION DRUG fluoxetine hydrochloride fluoxetine hydrochloride TABLET, COATED ORAL 20160822 ANDA ANDA203836 Par Pharmaceutical, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49884-336_5cdceb12-d10a-45e9-8115-e44e709b3fa3 49884-336 HUMAN PRESCRIPTION DRUG fluoxetine hydrochloride fluoxetine hydrochloride TABLET, COATED ORAL 20160822 ANDA ANDA203836 Par Pharmaceutical, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49884-339_416f9913-d186-4ada-a775-aba06dda7db7 49884-339 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170105 ANDA ANDA202842 Par Pharmaceutical, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 35 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 49884-347_e7e07fa7-9faa-4893-a15b-576ebc02c30f 49884-347 HUMAN PRESCRIPTION DRUG Pimozide Pimozide TABLET ORAL 20150928 ANDA ANDA204521 Par Pharmaceutical, Inc. PIMOZIDE 1 mg/1 Typical Antipsychotic [EPC] N 20181231 49884-348_e7e07fa7-9faa-4893-a15b-576ebc02c30f 49884-348 HUMAN PRESCRIPTION DRUG Pimozide Pimozide TABLET ORAL 20150928 ANDA ANDA204521 Par Pharmaceutical, Inc. PIMOZIDE 2 mg/1 Typical Antipsychotic [EPC] N 20181231 49884-358_4fa93c50-da5a-4aa7-aea2-01eab0d2f37f 49884-358 HUMAN PRESCRIPTION DRUG VIGABATRIN vigabatrin POWDER, FOR SOLUTION ORAL 20170427 ANDA ANDA208218 Par Pharmaceutical, Inc. VIGABATRIN 50 mg/mL Anti-epileptic Agent [EPC] N 20181231 49884-362_2decf1b9-9567-4351-8352-6e376ee86a84 49884-362 HUMAN PRESCRIPTION DRUG dantrolene sodium dantrolene sodium CAPSULE ORAL 20160328 NDA AUTHORIZED GENERIC NDA017443 Par Pharmaceutical, Inc. DANTROLENE SODIUM 25 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 49884-363_2decf1b9-9567-4351-8352-6e376ee86a84 49884-363 HUMAN PRESCRIPTION DRUG dantrolene sodium dantrolene sodium CAPSULE ORAL 20160328 NDA AUTHORIZED GENERIC NDA017443 Par Pharmaceutical, Inc. DANTROLENE SODIUM 50 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 49884-364_2decf1b9-9567-4351-8352-6e376ee86a84 49884-364 HUMAN PRESCRIPTION DRUG dantrolene sodium dantrolene sodium CAPSULE ORAL 20160328 NDA AUTHORIZED GENERIC NDA017443 Par Pharmaceutical, Inc. DANTROLENE SODIUM 100 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 49884-367_2beb116c-9681-4a10-8d54-4e3d772d88fb 49884-367 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium TABLET ORAL 20150908 ANDA ANDA206336 Par Pharmaceutical Inc. BALSALAZIDE DISODIUM 1.1 g/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 49884-373_ef69689b-d06c-4784-80c8-8226e6bd2e64 49884-373 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19831128 ANDA ANDA088481 Par Pharmaceutical Inc. DEXAMETHASONE 6 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49884-397_cea2adf4-ca6f-4872-b7a2-afb99dd8e23a 49884-397 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20160718 ANDA ANDA078966 Par Pharmaceutical Inc. OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 49884-401_32079395-365a-48a4-99e0-8770a87841ca 49884-401 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090601 ANDA ANDA077494 Par Pharmaceutical, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-402_32079395-365a-48a4-99e0-8770a87841ca 49884-402 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090601 ANDA ANDA077494 Par Pharmaceutical, Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-403_32079395-365a-48a4-99e0-8770a87841ca 49884-403 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090601 ANDA ANDA077494 Par Pharmaceutical, Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-404_4ab77f04-6b8c-42a6-aa8b-fbcca7a4ed22 49884-404 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20061121 20190831 NDA AUTHORIZED GENERIC NDA019962 Par Pharmaceutical Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49884-405_4ab77f04-6b8c-42a6-aa8b-fbcca7a4ed22 49884-405 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20070802 20191031 NDA AUTHORIZED GENERIC NDA019962 Par Pharmaceutical Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49884-406_4ab77f04-6b8c-42a6-aa8b-fbcca7a4ed22 49884-406 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20070726 20190930 NDA AUTHORIZED GENERIC NDA019962 Par Pharmaceutical Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49884-412_ce30ffda-4c61-4110-b827-e3daab7a72b3 49884-412 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20130801 ANDA ANDA202540 Par Pharmaceutical, Inc. URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 49884-413_ce30ffda-4c61-4110-b827-e3daab7a72b3 49884-413 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20130801 ANDA ANDA202540 Par Pharmaceutical, Inc. URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 49884-418_d1a361d7-3e2b-448f-a909-563700982faa 49884-418 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL TRANSDERMAL 20150902 ANDA ANDA076744 Par Pharmaceutical, Inc. TESTOSTERONE 25 mg/2.5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 49884-428_367b71aa-e462-4aeb-8f7e-a27728d7d4d5 49884-428 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20131119 ANDA ANDA078992 Par Pharmaceuticals, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 49884-430_367b71aa-e462-4aeb-8f7e-a27728d7d4d5 49884-430 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20131119 ANDA ANDA078992 Par Pharmaceuticals, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 49884-455_cea2adf4-ca6f-4872-b7a2-afb99dd8e23a 49884-455 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20160718 ANDA ANDA078966 Par Pharmaceutical Inc. OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 49884-459_118d40d5-78fe-453a-b476-1a3b232a6dea 49884-459 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Par Pharmaceutical Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-460_118d40d5-78fe-453a-b476-1a3b232a6dea 49884-460 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Par Pharmaceutical Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-461_118d40d5-78fe-453a-b476-1a3b232a6dea 49884-461 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Par Pharmaceutical Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-462_118d40d5-78fe-453a-b476-1a3b232a6dea 49884-462 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Par Pharmaceutical Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-463_118d40d5-78fe-453a-b476-1a3b232a6dea 49884-463 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Par Pharmaceutical Inc. FENTANYL CITRATE 1200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-464_118d40d5-78fe-453a-b476-1a3b232a6dea 49884-464 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 20111017 ANDA ANDA077312 Par Pharmaceutical Inc. FENTANYL CITRATE 1600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-465_e82385d4-d257-4a7b-ad54-1b96f79c2e0f 49884-465 HUMAN PRESCRIPTION DRUG Cholestyramine cholestyramine POWDER, FOR SUSPENSION ORAL 20050915 ANDA ANDA077204 Par Pharmaceutical, Inc. CHOLESTYRAMINE 4 g/9g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 49884-466_e82385d4-d257-4a7b-ad54-1b96f79c2e0f 49884-466 HUMAN PRESCRIPTION DRUG Cholestyramine cholestyramine POWDER, FOR SUSPENSION ORAL 20050915 ANDA ANDA077203 Par Pharmaceutical, Inc. CHOLESTYRAMINE 4 g/5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 49884-468_08c9b462-0c2c-4c00-91e2-ca0e6b954619 49884-468 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine TABLET, FILM COATED ORAL 20171116 ANDA ANDA209419 Par Pharmaceutical, Inc. FLUOXETINE HYDROCHLORIDE 60 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49884-484_a95eb62f-dabe-48be-ab32-379dc94d4b3c 49884-484 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20151216 ANDA ANDA204158 Par Pharmaceutical, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49884-485_a95eb62f-dabe-48be-ab32-379dc94d4b3c 49884-485 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20151216 ANDA ANDA204158 Par Pharmaceutical, Inc. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49884-486_a95eb62f-dabe-48be-ab32-379dc94d4b3c 49884-486 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20151216 ANDA ANDA204158 Par Pharmaceutical, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49884-487_a95eb62f-dabe-48be-ab32-379dc94d4b3c 49884-487 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20151216 ANDA ANDA204158 Par Pharmaceutical, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49884-494_a0f5ffea-2416-470a-b399-c35c8babc997 49884-494 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20140114 NDA AUTHORIZED GENERIC NDA020405 Par Pharmaceutical Inc. DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 49884-501_6f5e0c8c-0697-4975-88a6-0c88b29f0f30 49884-501 HUMAN PRESCRIPTION DRUG Budesonide Budesonide CAPSULE ORAL 20110818 NDA AUTHORIZED GENERIC NDA021324 Par Pharmaceutical Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49884-510_d1a361d7-3e2b-448f-a909-563700982faa 49884-510 HUMAN PRESCRIPTION DRUG Testosterone Testosterone GEL TRANSDERMAL 20150902 ANDA ANDA076744 Par Pharmaceutical, Inc. TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 49884-511_2cf85e27-1ed4-42df-ae5a-6fde2a6ed998 49884-511 HUMAN PRESCRIPTION DRUG Minocycline Minocycline TABLET ORAL 20030416 ANDA ANDA065131 Par Pharmaceutical, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 49884-512_2cf85e27-1ed4-42df-ae5a-6fde2a6ed998 49884-512 HUMAN PRESCRIPTION DRUG Minocycline Minocycline TABLET ORAL 20030416 ANDA ANDA065131 Par Pharmaceutical, Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 49884-513_2cf85e27-1ed4-42df-ae5a-6fde2a6ed998 49884-513 HUMAN PRESCRIPTION DRUG Minocycline Minocycline TABLET ORAL 20030416 ANDA ANDA065131 Par Pharmaceutical, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 49884-514_a0f5ffea-2416-470a-b399-c35c8babc997 49884-514 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20140114 NDA AUTHORIZED GENERIC NDA020405 Par Pharmaceutical Inc. DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 49884-534_0a4a2678-c1a0-41d1-b423-4ff0e9a8a1dd 49884-534 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120406 NDA AUTHORIZED GENERIC NDA020717 Par Pharmaceutical, Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 49884-535_0a4a2678-c1a0-41d1-b423-4ff0e9a8a1dd 49884-535 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120406 NDA AUTHORIZED GENERIC NDA020717 Par Pharmaceutical, Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 49884-539_416f9913-d186-4ada-a775-aba06dda7db7 49884-539 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170105 ANDA ANDA202842 Par Pharmaceutical, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 49884-545_842781c2-57fb-4d76-9389-7b8f1b79847b 49884-545 HUMAN PRESCRIPTION DRUG Ranitidine ranitidine TABLET ORAL 19990128 ANDA ANDA075180 Par Pharmaceutical Inc RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 49884-546_416f9913-d186-4ada-a775-aba06dda7db7 49884-546 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170105 ANDA ANDA202842 Par Pharmaceutical, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 49884-547_4a331b58-0095-421d-89a1-0ba413e654a5 49884-547 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, COATED ORAL 20170329 ANDA ANDA206294 Par Pharmaceutical, Inc. ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 49884-548_4a331b58-0095-421d-89a1-0ba413e654a5 49884-548 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, COATED ORAL 20170329 ANDA ANDA206294 Par Pharmaceutical, Inc. ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 49884-549_aa643c68-0079-4299-ba61-93a7b2d70f30 49884-549 HUMAN PRESCRIPTION DRUG Zafirlukast zafirlukast TABLET, COATED ORAL 20101119 NDA NDA020547 Par Pharmaceutical, Inc. ZAFIRLUKAST 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 49884-554_aa643c68-0079-4299-ba61-93a7b2d70f30 49884-554 HUMAN PRESCRIPTION DRUG Zafirlukast zafirlukast TABLET, COATED ORAL 20101119 NDA NDA020547 Par Pharmaceutical, Inc. ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 49884-561_c8beb57b-4b9c-4fc6-abd7-c86f50e2f98d 49884-561 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Par Pharmaceutical, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49884-562_c8beb57b-4b9c-4fc6-abd7-c86f50e2f98d 49884-562 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Par Pharmaceutical, Inc. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49884-563_c8beb57b-4b9c-4fc6-abd7-c86f50e2f98d 49884-563 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Par Pharmaceutical, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49884-564_c8beb57b-4b9c-4fc6-abd7-c86f50e2f98d 49884-564 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Par Pharmaceutical, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49884-574_7c4057df-ac2c-40bb-9ccb-be5872b43306 49884-574 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan amlodipine and valsartan TABLET ORAL 20140930 ANDA ANDA090011 Par Pharmaceutical, Inc. AMLODIPINE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 49884-575_7c4057df-ac2c-40bb-9ccb-be5872b43306 49884-575 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan amlodipine and valsartan TABLET ORAL 20140930 ANDA ANDA090011 Par Pharmaceutical, Inc. AMLODIPINE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 49884-576_7c4057df-ac2c-40bb-9ccb-be5872b43306 49884-576 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan amlodipine and valsartan TABLET ORAL 20140930 ANDA ANDA090144 Par Pharmaceutical, Inc. AMLODIPINE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 49884-577_7c4057df-ac2c-40bb-9ccb-be5872b43306 49884-577 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan amlodipine and valsartan TABLET ORAL 20140930 ANDA ANDA090011 Par Pharmaceutical, Inc. AMLODIPINE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 49884-580_a21eeb04-f516-41fb-91f3-39f2c698af47 49884-580 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 19980629 20180430 NDA AUTHORIZED GENERIC NDA020865 Par Pharmaceutical Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 49884-589_d31ecca3-23ff-470e-8c91-1bea8a537b3c 49884-589 HUMAN PRESCRIPTION DRUG Accolate zafirlukast TABLET, COATED ORAL 20151101 NDA NDA020547 Par Pharmaceutical Inc. ZAFIRLUKAST 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 49884-590_d31ecca3-23ff-470e-8c91-1bea8a537b3c 49884-590 HUMAN PRESCRIPTION DRUG Accolate zafirlukast TABLET, COATED ORAL 20151101 NDA NDA020547 Par Pharmaceutical Inc. ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 49884-604_c8beb57b-4b9c-4fc6-abd7-c86f50e2f98d 49884-604 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Par Pharmaceutical, Inc. LAMOTRIGINE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49884-605_c8beb57b-4b9c-4fc6-abd7-c86f50e2f98d 49884-605 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Par Pharmaceutical, Inc. LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 49884-611_c1d1c81d-5ab7-49f9-a69a-d18868bd27c7 49884-611 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE ORAL 20170315 ANDA ANDA207199 Par Pharmaceutical, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 49884-640_d5f1fcca-e3b3-4bd9-9c29-0e2be4255afe 49884-640 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20000329 ANDA ANDA040350 Par Pharmaceutical, Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 49884-641_d5f1fcca-e3b3-4bd9-9c29-0e2be4255afe 49884-641 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20000329 ANDA ANDA040350 Par Pharmaceutical, Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 49884-649_8a87dcd6-883f-486e-8f4a-8ff1e6080140 49884-649 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20030124 ANDA ANDA076009 Par Pharmaceutical Inc NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 49884-650_8a87dcd6-883f-486e-8f4a-8ff1e6080140 49884-650 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20030124 ANDA ANDA076009 Par Pharmaceutical Inc NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 49884-658_d8c1369c-6b62-4e4c-80ef-0abacebb7b34 49884-658 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 NDA AUTHORIZED GENERIC NDA020838 Par Pharmaceutical Inc. CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 49884-659_d8c1369c-6b62-4e4c-80ef-0abacebb7b34 49884-659 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 NDA AUTHORIZED GENERIC NDA020838 Par Pharmaceutical Inc. CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 49884-660_d8c1369c-6b62-4e4c-80ef-0abacebb7b34 49884-660 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 NDA AUTHORIZED GENERIC NDA020838 Par Pharmaceutical Inc. CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 49884-661_d8c1369c-6b62-4e4c-80ef-0abacebb7b34 49884-661 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 NDA AUTHORIZED GENERIC NDA020838 Par Pharmaceutical Inc. CANDESARTAN CILEXETIL 32 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 49884-665_eeecad4f-c932-4099-9448-674fbdc04e21 49884-665 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Par Pharmaceutical Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-666_eeecad4f-c932-4099-9448-674fbdc04e21 49884-666 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Par Pharmaceutical Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-667_eeecad4f-c932-4099-9448-674fbdc04e21 49884-667 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Par Pharmaceutical Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-668_eeecad4f-c932-4099-9448-674fbdc04e21 49884-668 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Par Pharmaceutical Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-669_eeecad4f-c932-4099-9448-674fbdc04e21 49884-669 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Par Pharmaceutical Inc. MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-670_eeecad4f-c932-4099-9448-674fbdc04e21 49884-670 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20111110 ANDA ANDA200812 Par Pharmaceutical Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-673_1bef161f-47c6-445e-8006-dec4a68f5ed6 49884-673 HUMAN PRESCRIPTION DRUG Cabergoline Cabergoline TABLET ORAL 20051229 ANDA ANDA076310 Par Pharmaceutical, Inc. CABERGOLINE .5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 49884-677_be0ad7fd-6e38-496c-969c-7f4633295f20 49884-677 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20070622 ANDA ANDA077899 Par Pharmaceutical, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 49884-678_be0ad7fd-6e38-496c-969c-7f4633295f20 49884-678 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20070622 ANDA ANDA077899 Par Pharmaceutical, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 49884-679_0fffb6c5-dfc5-4d13-bc1f-d4a35f3f66fe 49884-679 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20120529 ANDA ANDA077899 Par Pharmaceutical, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 49884-685_ed6e4a1f-1157-4d47-ad75-f588976fa406 49884-685 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19851017 ANDA ANDA070581 Par Pharmaceutical Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 49884-689_ed6e4a1f-1157-4d47-ad75-f588976fa406 49884-689 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19851017 ANDA ANDA070581 Par Pharmaceutical Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 49884-701_838a5383-870c-405b-b427-95e01c0bd99f 49884-701 HUMAN PRESCRIPTION DRUG Clomiphene Citrate Clomiphene Citrate TABLET ORAL 19990830 ANDA ANDA075528 Par Pharmaceutical, Inc. CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 49884-719_c1d1c81d-5ab7-49f9-a69a-d18868bd27c7 49884-719 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE ORAL 20170315 ANDA ANDA207199 Par Pharmaceutical, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 49884-724_fbad4bdf-7141-499c-8984-46d39f2149fa 49884-724 HUMAN PRESCRIPTION DRUG Hydroxyurea Hydroxyurea CAPSULE ORAL 19990224 ANDA ANDA075340 Par Pharmaceutical, Inc. HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] N 20181231 49884-725_c7cbd4c5-c83d-482f-9321-c6e178f93a8c 49884-725 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20120423 ANDA ANDA075467 Par Pharmaceutical Inc. BUSPIRONE HYDROCHLORIDE 7.5 mg/1 N 20181231 49884-726_e0c4cd47-bf67-48de-b28e-201628fbf312 49884-726 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20001201 ANDA ANDA065055 Par Pharmaceutical, Inc. DOXYCYCLINE 50 mg/1 N 20191231 49884-727_e0c4cd47-bf67-48de-b28e-201628fbf312 49884-727 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20001201 ANDA ANDA065055 Par Pharmaceutical, Inc. DOXYCYCLINE 100 mg/1 N 20191231 49884-732_1e4f1def-9e2e-4879-ace2-b20a8b3c2ff0 49884-732 HUMAN PRESCRIPTION DRUG SUMYCIN Tetracycline Hydrochloride TABLET, FILM COATED ORAL 20170404 ANDA ANDA061147 Par Pharmaceutical, Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 49884-733_1e4f1def-9e2e-4879-ace2-b20a8b3c2ff0 49884-733 HUMAN PRESCRIPTION DRUG SUMYCIN Tetracycline Hydrochloride TABLET, FILM COATED ORAL 20170404 ANDA ANDA061147 Par Pharmaceutical, Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 49884-745_15166897-a5ff-41a5-8e74-68b86efb2b60 49884-745 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130923 ANDA ANDA076159 Par Pharmaceutical, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 49884-746_15166897-a5ff-41a5-8e74-68b86efb2b60 49884-746 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130923 ANDA ANDA076159 Par Pharmaceutical, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 49884-753_763976d4-d47d-45c8-af0a-7f16e53ae743 49884-753 HUMAN PRESCRIPTION DRUG Flutamide Flutamide CAPSULE ORAL 20060126 ANDA ANDA075298 Par Pharmaceutical, Inc. FLUTAMIDE 125 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 49884-761_d0358673-e6f2-42e2-87cb-73bfcb52c4f6 49884-761 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20070820 ANDA ANDA077062 Par Pharmaceutical Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49884-762_d0358673-e6f2-42e2-87cb-73bfcb52c4f6 49884-762 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20070820 ANDA ANDA077062 Par Pharmaceutical Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49884-763_d0358673-e6f2-42e2-87cb-73bfcb52c4f6 49884-763 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20070820 ANDA ANDA077062 Par Pharmaceutical Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49884-764_d0358673-e6f2-42e2-87cb-73bfcb52c4f6 49884-764 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20070820 ANDA ANDA077062 Par Pharmaceutical Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49884-765_c1d1c81d-5ab7-49f9-a69a-d18868bd27c7 49884-765 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE ORAL 20170315 ANDA ANDA207199 Par Pharmaceutical, Inc. TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 49884-771_f52af01e-b8a1-44e5-a1b1-ba5d779d06e5 49884-771 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20000526 ANDA ANDA040357 Par Pharmaceutical, Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 49884-773_e214a64e-c56e-4292-aeca-00d55f0f7efd 49884-773 HUMAN PRESCRIPTION DRUG TIZANIDINE TIZANIDINE TABLET ORAL 20170117 ANDA ANDA207170 Par Pharmaceutical, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 49884-786_f30c005f-57a2-44ac-a4b0-0e7ad279302a 49884-786 HUMAN PRESCRIPTION DRUG olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 ANDA ANDA206137 Par Pharmaceutical, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 20; 5; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49884-787_f30c005f-57a2-44ac-a4b0-0e7ad279302a 49884-787 HUMAN PRESCRIPTION DRUG olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 ANDA ANDA206137 Par Pharmaceutical, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 5; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49884-788_f30c005f-57a2-44ac-a4b0-0e7ad279302a 49884-788 HUMAN PRESCRIPTION DRUG olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 ANDA ANDA206137 Par Pharmaceutical, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 5; 25 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49884-789_f30c005f-57a2-44ac-a4b0-0e7ad279302a 49884-789 HUMAN PRESCRIPTION DRUG olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 ANDA ANDA206137 Par Pharmaceutical, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 10; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49884-790_f30c005f-57a2-44ac-a4b0-0e7ad279302a 49884-790 HUMAN PRESCRIPTION DRUG olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 ANDA ANDA206137 Par Pharmaceutical, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 10; 25 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49884-805_d3b42f13-187f-48f5-b554-140cdf829fca 49884-805 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended Release Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20161101 NDA AUTHORIZED GENERIC NDA022047 Par Pharmaceutical Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-806_d3b42f13-187f-48f5-b554-140cdf829fca 49884-806 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended Release Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20161101 NDA AUTHORIZED GENERIC NDA022047 Par Pharmaceutical Inc. QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-807_d3b42f13-187f-48f5-b554-140cdf829fca 49884-807 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended Release Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20161101 NDA AUTHORIZED GENERIC NDA022047 Par Pharmaceutical Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-808_d3b42f13-187f-48f5-b554-140cdf829fca 49884-808 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended Release Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20161101 NDA AUTHORIZED GENERIC NDA022047 Par Pharmaceutical Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 49884-821_ba9bb1c8-a1d5-4d8b-a391-c5780701492d 49884-821 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20120628 ANDA ANDA078783 Par Pharmaceutical, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 49884-822_ba9bb1c8-a1d5-4d8b-a391-c5780701492d 49884-822 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20120628 ANDA ANDA078783 Par Pharmaceutical, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 49884-823_ba9bb1c8-a1d5-4d8b-a391-c5780701492d 49884-823 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20120628 ANDA ANDA078783 Par Pharmaceutical, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 49884-825_4ab77f04-6b8c-42a6-aa8b-fbcca7a4ed22 49884-825 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20061121 NDA AUTHORIZED GENERIC NDA019962 Par Pharmaceutical Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49884-826_4ab77f04-6b8c-42a6-aa8b-fbcca7a4ed22 49884-826 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20070802 NDA AUTHORIZED GENERIC NDA019962 Par Pharmaceutical Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49884-827_4ab77f04-6b8c-42a6-aa8b-fbcca7a4ed22 49884-827 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20070726 NDA AUTHORIZED GENERIC NDA019962 Par Pharmaceutical Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49884-828_4ab77f04-6b8c-42a6-aa8b-fbcca7a4ed22 49884-828 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20070726 NDA AUTHORIZED GENERIC NDA019962 Par Pharmaceutical Inc. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49884-829_2268b074-1ba9-42ff-b496-8913ef8cd21c 49884-829 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Par Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 49884-830_2268b074-1ba9-42ff-b496-8913ef8cd21c 49884-830 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Par Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 49884-831_2268b074-1ba9-42ff-b496-8913ef8cd21c 49884-831 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Par Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 49884-832_2268b074-1ba9-42ff-b496-8913ef8cd21c 49884-832 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991224 ANDA ANDA074984 Par Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 49884-833_db8c1cd9-742a-496a-9715-53208e23695a 49884-833 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20121109 NDA NDA020616 Par Pharmaceutical Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-834_db8c1cd9-742a-496a-9715-53208e23695a 49884-834 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20121109 NDA NDA020616 Par Pharmaceutical Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-835_db8c1cd9-742a-496a-9715-53208e23695a 49884-835 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20121109 NDA NDA020616 Par Pharmaceutical Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-836_db8c1cd9-742a-496a-9715-53208e23695a 49884-836 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20121109 NDA NDA020616 Par Pharmaceutical Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-837_db8c1cd9-742a-496a-9715-53208e23695a 49884-837 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20121109 NDA NDA020616 Par Pharmaceutical Inc. MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-838_db8c1cd9-742a-496a-9715-53208e23695a 49884-838 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20121109 NDA NDA020616 Par Pharmaceutical Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49884-867_ec1753de-3762-4398-820c-2e4dcc5f4915 49884-867 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20080627 ANDA ANDA078292 Par Pharmaceutical, Inc. DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 49884-868_ec1753de-3762-4398-820c-2e4dcc5f4915 49884-868 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20080627 ANDA ANDA078292 Par Pharmaceutical, Inc. DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 49884-869_ec1753de-3762-4398-820c-2e4dcc5f4915 49884-869 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20080627 ANDA ANDA078292 Par Pharmaceutical, Inc. DRONABINOL 10 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 49884-872_bba4eccb-50e0-4d28-b214-39560fc1921b 49884-872 HUMAN PRESCRIPTION DRUG FLUOXETINE fluoxetine hydrochloride CAPSULE ORAL 20081014 ANDA ANDA076922 Par Pharmaceutical, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 49884-898_c9d4355d-73af-4804-b747-a28dbe49f1c4 49884-898 HUMAN PRESCRIPTION DRUG Zolpidem tartrate sublingual Zolpidem tartrate sublingual TABLET SUBLINGUAL 20170911 ANDA ANDA204229 Par Pharmaceutical, Inc. ZOLPIDEM TARTRATE 1.75 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 49884-899_c9d4355d-73af-4804-b747-a28dbe49f1c4 49884-899 HUMAN PRESCRIPTION DRUG Zolpidem tartrate sublingual Zolpidem tartrate sublingual TABLET SUBLINGUAL 20170911 ANDA ANDA204229 Par Pharmaceutical, Inc. ZOLPIDEM TARTRATE 3.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 49884-902_2ac267d5-35a9-4310-be5b-97b5dd6c46cb 49884-902 HUMAN PRESCRIPTION DRUG Mafenide acetate Mafenide acetate POWDER, FOR SOLUTION TOPICAL 20130212 ANDA ANDA201511 Par Pharmaceutical, Inc. MAFENIDE ACETATE 50 g/1 Methylated Sulfonamide Antibacterial [EPC],Methylated Sulfonamides [Chemical/Ingredient] N 20181231 49884-903_8b4f7e3a-55b9-45ad-9ee9-55273c8758e3 49884-903 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET SUBLINGUAL 20161104 ANDA ANDA201509 Par Pharmaceutical, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 49884-904_8b4f7e3a-55b9-45ad-9ee9-55273c8758e3 49884-904 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET SUBLINGUAL 20161104 ANDA ANDA201509 Par Pharmaceutical, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 49884-905_2d45648f-cbea-41a4-8e3e-007b7bb7912c 49884-905 HUMAN PRESCRIPTION DRUG Diclofenac Potassium for Oral Solution Diclofenac Potassium for Oral Solution POWDER ORAL 20151001 ANDA ANDA202964 Par Pharmaceutical Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49884-907_20e0b65b-e860-46aa-885f-61d2dc46ed67 49884-907 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20010725 ANDA ANDA075671 Par Pharmaceutical, Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 49884-922_4d29e7e8-7d71-403f-aae1-ea79e1e0e0ef 49884-922 HUMAN PRESCRIPTION DRUG mercaptopurine mercaptopurine TABLET ORAL 20040211 ANDA ANDA040461 Par Pharmaceutical Inc. MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 49884-929_a7dff6fb-1626-4f44-8ca1-34191eaaae84 49884-929 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Par Pharmaceutical Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 49884-930_a7dff6fb-1626-4f44-8ca1-34191eaaae84 49884-930 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Par Pharmaceutical Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 49884-931_a7dff6fb-1626-4f44-8ca1-34191eaaae84 49884-931 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Par Pharmaceutical Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 49884-932_a7dff6fb-1626-4f44-8ca1-34191eaaae84 49884-932 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Par Pharmaceutical Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 49884-935_f742b66a-5045-44b7-8551-bcd067f3087d 49884-935 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium GEL TOPICAL 20160701 NDA AUTHORIZED GENERIC NDA022122 Par Pharmaceutical Inc DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49884-936_cbafb444-c4f5-4230-8d90-b023aaca26ea 49884-936 HUMAN PRESCRIPTION DRUG QUESTRAN Cholestyramine POWDER, FOR SUSPENSION ORAL 20050915 ANDA ANDA077204 Par Pharmaceutical, Inc. CHOLESTYRAMINE 4 g/9g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 49884-937_cbafb444-c4f5-4230-8d90-b023aaca26ea 49884-937 HUMAN PRESCRIPTION DRUG QUESTRAN Cholestyramine POWDER, FOR SUSPENSION ORAL 20030724 ANDA ANDA077203 Par Pharmaceutical, Inc. CHOLESTYRAMINE 4 g/5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 49884-946_dad8854e-8808-4c46-8a4b-e38c513ddc48 49884-946 HUMAN PRESCRIPTION DRUG Tramadol hydrochloride and acetaminophen tramadol hydrochloride and acetaminophen TABLET ORAL 20050421 ANDA ANDA076475 Par Pharmaceutical, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 49884-947_e214a64e-c56e-4292-aeca-00d55f0f7efd 49884-947 HUMAN PRESCRIPTION DRUG TIZANIDINE TIZANIDINE TABLET ORAL 20170117 ANDA ANDA207170 Par Pharmaceutical, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 49884-949_ad5147c4-60e0-442f-b4fd-41d1956d7724 49884-949 HUMAN PRESCRIPTION DRUG Megace ES megesterol acetate SUSPENSION ORAL 20050702 NDA NDA021778 Par Pharmaceutical, Inc MEGESTROL ACETATE 125 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 49884-952_a7dff6fb-1626-4f44-8ca1-34191eaaae84 49884-952 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Par Pharmaceutical Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 49884-953_a7dff6fb-1626-4f44-8ca1-34191eaaae84 49884-953 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Par Pharmaceutical Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 49884-984_40b9fd61-fa6e-4d91-8196-ae6b29d559c9 49884-984 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20090908 ANDA ANDA077463 Par Pharmaceutical, Inc. NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 49884-985_40b9fd61-fa6e-4d91-8196-ae6b29d559c9 49884-985 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20090908 ANDA ANDA077463 Par Pharmaceutical, Inc. NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 49886-001_0be179e8-6b58-424d-8af2-be237a80bc84 49886-001 HUMAN OTC DRUG Migralex Dr. Mauskop Aspirin buffered with magnesium oxide TABLET, COATED ORAL 20091115 OTC MONOGRAPH NOT FINAL part343 Migralex Inc. ASPIRIN; MAGNESIUM OXIDE 500; 75 mg/1; mg/1 E 20171231 49889-1906_039b0db0-90f0-4f2b-aa43-80aa439c5f8a 49889-1906 HUMAN OTC DRUG Germ Crusher Hand Sanitizer Wipes Germ Crusher Hand Sanitizer Wipes CLOTH TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 GMS Industrial Supply, Inc. BENZALKONIUM CHLORIDE; BENZETHONIUM CHLORIDE .1; .1 g/970mL; g/970mL E 20171231 49892-0002_aa4d0cde-7167-46ff-9af0-88a89f8a81af 49892-0002 HUMAN OTC DRUG Musco MXT Aralia quinquefolia, Epiphegus virginiana, Jacaranda caroba, Lacticum acidum, Hydrocotyle asiatica, Hydrocyanicum acidum, LIQUID ORAL 20130627 UNAPPROVED HOMEOPATHIC Sandco International, Inc PANAX QUINQUEFOLIUS WHOLE; EPIFAGUS VIRGINIANA; JACARANDA CAROBA FLOWER; LACTIC ACID, DL-; CENTELLA ASIATICA; HYDROGEN CYANIDE 15; 15; 15; 15; 100; 100 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 49893-100_f2258cda-072e-413f-8feb-07bcbd11218a 49893-100 HUMAN OTC DRUG Total Suncare Sunscreen SPF 15 AVOBENZONE, OCTISALATE, OCTINOXATE, OXYBENZONE SPRAY TOPICAL 20091125 OTC MONOGRAPH FINAL part352 Total Suncare LLC AVOBENZONE; OCTISALATE; OCTINOXATE; OXYBENZONE 2; 2; 1; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 49893-200_b07bf5e6-4502-438f-8ed5-a21e3f3ccbf7 49893-200 HUMAN OTC DRUG Total Suncare Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTINOXATE, OXYBENZONE SPRAY TOPICAL 20091125 OTC MONOGRAPH FINAL part352 Total Suncare LLC AVOBENZONE; OCTISALATE; OCTINOXATE; OXYBENZONE 3; 2; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 49893-300_53d8c96e-f8df-4033-851c-c7cb0337d018 49893-300 HUMAN OTC DRUG Total Suncare Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE SPRAY TOPICAL 20091125 OTC MONOGRAPH FINAL part352 Total Suncare LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 10; 3; 3; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 49893-500_3ff235f5-6093-482c-a0f8-20498228e063 49893-500 HUMAN OTC DRUG Total Suncare Sunscreen SPF 70 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE SPRAY TOPICAL 20091208 OTC MONOGRAPH FINAL part352 Total Suncare LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 15; 5; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 49902-3591_64557d60-ef59-4ef5-8991-a11a9de25c07 49902-3591 HUMAN OTC DRUG NEW BRAND PERFUMES MENS ROLL ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20101213 OTC MONOGRAPH FINAL part350 BB TRADING WORLDWIDE, INC ALUMINUM CHLOROHYDRATE 25 mL/100mL E 20171231 49902-3690_dabaa933-c04f-4182-8c6a-371339312093 49902-3690 HUMAN OTC DRUG CUBA ORIGINAL MENS ROLL ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100831 OTC MONOGRAPH FINAL part350 BB TRADING WORLDWIDE, INC ALUMINUM CHLOROHYDRATE 25 mL/100mL E 20171231 49902-3942_b839191c-1417-487c-8761-07c324473111 49902-3942 HUMAN OTC DRUG CUBA ORIGINAL LADIES ROLL ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100831 OTC MONOGRAPH FINAL part350 BB TRADING WORLDWIDE, INC ALUMINUM CHLOROHYDRATE 25 mL/100mL E 20171231 49902-5366_63dfb796-b13e-42c2-b337-4ec178f24b4b 49902-5366 HUMAN OTC DRUG NEW BRAND PERFUMES LADIES ROLL ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20101213 OTC MONOGRAPH FINAL part350 BB TRADING WORLDWIDE, INC ALUMINUM CHLOROHYDRATE 25 mL/100mL E 20171231 49908-117_3d32addc-f42a-6b9c-e054-00144ff8d46c 49908-117 HUMAN PRESCRIPTION DRUG Adapalene Topical Solution Adapalene Topical Solution SOLUTION TOPICAL 20161003 ANDA ANDA203981 CALL INC (d.b.a Rochester Pharmaceuticals) ADAPALENE 1 mg/mL Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 49908-118_28c09b4a-dc3a-3abb-e054-00144ff8d46c 49908-118 HUMAN PRESCRIPTION DRUG Adapalene Adapalene SWAB TOPICAL 20160105 ANDA ANDA204593 CALL INC. (dba Rochester Pharmaceuticals) ADAPALENE 1 mg/mL Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 49908-137_5513abaa-8811-4bf5-e054-00144ff8d46c 49908-137 HUMAN PRESCRIPTION DRUG Salicylic Acid Salicylic Acid LIQUID TOPICAL 20110330 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals SALICYLIC ACID 260 mg/mL N 20181231 49908-146_56e0f978-c892-4957-e054-00144ff88e88 49908-146 HUMAN PRESCRIPTION DRUG SELENIUM SULFIDE SELENIUM SULFIDE SHAMPOO TOPICAL 20110330 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals SELENIUM SULFIDE 22.5 mg/mL N 20181231 49908-150_5512777b-e07d-0b9f-e054-00144ff88e88 49908-150 HUMAN PRESCRIPTION DRUG PRAMCORT HYDROCORTISONE ACETATE and PRAMOXINE HYDROCHLORIDE CREAM TOPICAL 20110330 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49908-167_2430c9f9-e79c-5791-e054-00144ff88e88 49908-167 HUMAN PRESCRIPTION DRUG FORMALDEHYDE FORMALDEHYDE SOLUTION TOPICAL 20110427 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals FORMALDEHYDE 100 mg/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC] N 20181231 49908-173_243102f5-8597-2911-e054-00144ff8d46c 49908-173 HUMAN PRESCRIPTION DRUG SODIUM SULFACETAMIDE and SULFUR SODIUM SULFACETAMIDE and SULFUR CREAM TOPICAL 20110804 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals SULFACETAMIDE SODIUM; SULFUR 90; 45 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 49908-237_55134586-07c4-2b76-e054-00144ff8d46c 49908-237 HUMAN PRESCRIPTION DRUG Salicylic Acid Salicylic Acid LIQUID TOPICAL 20111107 UNAPPROVED DRUG OTHER Rochester Pharmaceuticals SALICYLIC ACID 275 mg/mL N 20181231 49909-005_6f7883fc-9561-fb7c-6cd3-55678f75aedd 49909-005 HUMAN PRESCRIPTION DRUG Fluoxetine HCl Fluoxetine HCl TABLET, FILM COATED ORAL 20111114 NDA NDA202133 Edgemont Pharmaceuticals, LLC FLUOXETINE HYDROCHLORIDE 60 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49909-010_6bcdd4f3-e369-b5c7-f7d2-1fdbb9a0aef0 49909-010 HUMAN PRESCRIPTION DRUG Forfivo XL bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121001 NDA NDA022497 Edgemont Pharmaceuticals, LLC BUPROPION HYDROCHLORIDE 450 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 49911-884_d5ee882b-fa9c-4657-9488-fa81bee09dfc 49911-884 HUMAN OTC DRUG Plum Smooth Plumb Numb Gelee Lidocaine GEL TOPICAL 20120329 OTC MONOGRAPH NOT FINAL part348 Universal Companies, Inc. LIDOCAINE 4 g/100g N 20181231 49922-001_f2b8ef51-43a1-4f9a-a810-30ff727fdfa2 49922-001 HUMAN OTC DRUG Secure Instant Foaming Hand Sanitizer Hand Sanitizer LIQUID TOPICAL 20091005 OTC MONOGRAPH NOT FINAL part333 American Cleaning Solutions BENZALKONIUM CHLORIDE .1 mL/100mL E 20171231 49922-002_6d36a498-239e-4f67-b44f-c21e31de900b 49922-002 HUMAN OTC DRUG Secure Instant Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333A American Cleaning Solutions BENZALKONIUM CHLORIDE .1 mL/100mL E 20171231 49924-1231_dd3a1acb-ee7e-4acb-8a22-108f513aa57d 49924-1231 HUMAN OTC DRUG On Guard Hand Sanitizing Wipe Alcohol CLOTH TOPICAL 20091101 OTC MONOGRAPH FINAL part358 do Terra ALCOHOL 1 ug/mL E 20171231 49930-001_e7c36f95-b15d-4bef-89c9-cf87eaf1f6c3 49930-001 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20141117 ANDA ANDA200981 Rubicon Research Private Limited METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 49930-002_e7c36f95-b15d-4bef-89c9-cf87eaf1f6c3 49930-002 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20141117 ANDA ANDA200981 Rubicon Research Private Limited METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 49930-003_e7c36f95-b15d-4bef-89c9-cf87eaf1f6c3 49930-003 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20141117 ANDA ANDA200981 Rubicon Research Private Limited METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 49936-1303_9a2ac669-27ef-4908-84ee-c5ed10fa22c9 49936-1303 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091117 UNAPPROVED MEDICAL GAS Orsini Home Medical Equipment Inc. OXYGEN 1 L/L E 20171231 49938-101_981fd618-fc7b-4916-8482-04e1f3e8b271 49938-101 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 19790703 ANDA ANDA086842 Jacobus Pharmaceutical Company, Inc. DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 49938-101_9b4f801d-0290-4662-b7b8-26d7d2538425 49938-101 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20080815 ANDA ANDA086842 Jacobus Pharmaceutical Company, Inc. DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 49938-102_981fd618-fc7b-4916-8482-04e1f3e8b271 49938-102 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 19790703 ANDA ANDA086841 Jacobus Pharmaceutical Company, Inc. DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 49938-102_9b4f801d-0290-4662-b7b8-26d7d2538425 49938-102 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20080815 ANDA ANDA086841 Jacobus Pharmaceutical Company, Inc. DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 49938-107_122349ff-58d4-4ddc-a589-3a4e2d8c3816 49938-107 HUMAN PRESCRIPTION DRUG Paser AMINOSALICYLIC ACID GRANULE, DELAYED RELEASE ORAL 19950215 ANDA ANDA074346 Jacobus Pharmaceutical Company, Inc. AMINOSALICYLIC ACID 4 g/1 N 20181231 49939-201_bd5cc995-1925-4260-8999-6ea8cac811f7 49939-201 HUMAN OTC DRUG NeutraCaine Benzocaine hydrochloride POWDER, FOR SOLUTION ORAL 20140307 OTC MONOGRAPH NOT FINAL part356 Invado Pharmaceuticals, LLC BENZOCAINE HYDROCHLORIDE 90 mg/1 E 20171231 49944-001_eae13135-3dbc-48f0-86ff-2dee3bd51bdf 49944-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS I.D.M. Medical Supply Company Inc. OXYGEN 99 L/100L N 20181231 49944-010_eae13135-3dbc-48f0-86ff-2dee3bd51bdf 49944-010 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS I.D.M. Medical Supply Company Inc. OXYGEN 99 L/100L N 20181231 49947-001_4f4cbaa4-fdea-4105-a702-9b239e454951 49947-001 HUMAN OTC DRUG Hush Anesthetic Lidocaine SPRAY TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 HUSH Anesthetic LIDOCAINE 40 mg/g N 20181231 49947-002_2c28e5a6-6651-4978-92ac-5b24d8daeff0 49947-002 HUMAN OTC DRUG Hush Anesthetic Lidocaine GEL TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 HUSH Anesthetic LIDOCAINE 40 mg/g N 20181231 49947-003_202ea613-ef09-401a-8b5c-5027a09d2190 49947-003 HUMAN OTC DRUG Hush Anesthetic Lidocaine, Benzalkonium Chloride SOAP TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part348 HUSH Anesthetic LIDOCAINE; BENZALKONIUM CHLORIDE 40; 1.3 mg/g; mg/g N 20181231 49952-001_9d448bee-41f5-4baa-a356-d0f457a73f58 49952-001 HUMAN OTC DRUG Zhenweilong Huoluo You External Analgesic Camphor Menthol Methyl Salicylate OIL TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 Uncle Bill Trading USA Inc. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 10; 15; 30 g/100mL; g/100mL; g/100mL E 20171231 49952-002_8e73e7ef-56a4-469f-9ace-b89c926745fa 49952-002 HUMAN OTC DRUG Jun Wai Lung Medicine Pain relieving Camphor Menthol Methyl Salicylate OIL TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 Uncle Bill Trading USA Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 15; 33 g/100mL; g/100mL; g/100mL E 20171231 49952-003_ebe8ddad-525c-43b4-922d-f3ed97bd0b5d 49952-003 HUMAN OTC DRUG Zihuadick Pain relieving Camphor Menthol Methyl Salicylate LIQUID TOPICAL 20131230 OTC MONOGRAPH NOT FINAL part348 Uncle Bill Trading USA Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3; 10; 10 g/100mL; g/100mL; g/100mL E 20171231 49952-004_d831d537-3a36-4410-9c18-e980e1f36e45 49952-004 HUMAN OTC DRUG ZIHUA EMBROCATION Cooling Pain Relief Camphor Menthol Methyl Salicylate OIL TOPICAL 20140415 OTC MONOGRAPH NOT FINAL part348 Uncle Bill Trading USA Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 11; 15; 15 g/100mL; g/100mL; g/100mL E 20171231 49953-1893_aeb97fea-9573-4a32-a452-9e4d704c3c3f 49953-1893 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SWAB TOPICAL 20100702 OTC MONOGRAPH FINAL part333C Dalian Rongbang Medical Healthy Devices Co POVIDONE-IODINE 10 mL/100mL N 20181231 49953-1894_e2f13ed7-395b-4bb6-aa3d-2516921a107c 49953-1894 HUMAN OTC DRUG Lemon Glycerin Glycerine SWAB TOPICAL 20100702 OTC MONOGRAPH FINAL part349 Dalian Rongbang Medical Healthy Devices Co GLYCERIN .43 mL/10mL N 20181231 49953-2801_41fc6c25-9999-6e44-e054-00144ff88e88 49953-2801 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20100702 OTC MONOGRAPH FINAL part344 Dalian Rongbang Medical Healthy Devices Co., Ltd. ISOPROPYL ALCOHOL 7 mL/10mL N 20181231 49953-2801_42669cda-156e-4181-e054-00144ff8d46c 49953-2801 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20100702 OTC MONOGRAPH FINAL part344 Dalian Rongbang Medical Healthy Devices Co., Ltd. ISOPROPYL ALCOHOL 7 mL/10mL N 20181231 49953-2805_39e6ca2b-0fb9-42ae-91f3-b7e1b71c8687 49953-2805 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SWAB TOPICAL 20100702 OTC MONOGRAPH FINAL part333C Dalian Rongbang Medical Healthy Devices Co POVIDONE-IODINE 1 mL/10mL N 20181231 49955-100_1f8fe83c-fcaf-489e-b0b8-01817ee2a81a 49955-100 HUMAN OTC DRUG Azuro ALCOHOL GEL TOPICAL 20091118 OTC MONOGRAPH NOT FINAL part333 Noveko Inc ALCOHOL .7 L/L E 20171231 49955-600_0c3d075b-8b9a-4c6d-a431-7eff637819fe 49955-600 HUMAN OTC DRUG Microban ALCOHOL GEL TOPICAL 20091118 OTC MONOGRAPH NOT FINAL part333 Noveko Inc ALCOHOL .7 L/L E 20171231 49955-610_48e0ca8e-637a-4cc7-bd2a-a4ea7061becc 49955-610 HUMAN OTC DRUG Microban Unscented ALCOHOL GEL TOPICAL 20091118 OTC MONOGRAPH NOT FINAL part333 Noveko Inc ALCOHOL .7 L/L E 20171231 49955-680_542a1fa4-24f2-4ce6-96b2-58095b899d90 49955-680 HUMAN OTC DRUG Microban 80 ALCOHOL GEL TOPICAL 20091118 OTC MONOGRAPH NOT FINAL part333 Noveko Inc ALCOHOL .8 L/L E 20171231 49955-700_494b48be-e227-332f-e054-00144ff88e88 49955-700 HUMAN OTC DRUG Amoveo 80% ALCOHOL LIQUID TOPICAL 20170224 OTC MONOGRAPH NOT FINAL part333E Protair-X Health Solutions Inc. ALCOHOL 800 mg/mL N 20181231 49955-701_494b48be-e238-332f-e054-00144ff88e88 49955-701 HUMAN OTC DRUG Amoveo Original ALCOHOL GEL TOPICAL 20170224 OTC MONOGRAPH NOT FINAL part333E Protair-X Health Solutions Inc. ALCOHOL 700 mg/mL N 20181231 49955-702_494b48be-e249-332f-e054-00144ff88e88 49955-702 HUMAN OTC DRUG Amoveo Unscented ALCOHOL GEL TOPICAL 20170224 OTC MONOGRAPH NOT FINAL part333E Protair-X Health Solutions Inc. ALCOHOL 700 mg/mL N 20181231 49959-1111_8b28802d-c750-4607-a01c-4ebaa25e115f 49959-1111 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol GEL TOPICAL 20091130 OTC MONOGRAPH FINAL part333 Graphic Controls ALCOHOL .6 g/mL N 20181231 49963-118_85b201f0-1f3b-4401-ad6d-b76c270ff883 49963-118 HUMAN OTC DRUG Bronkids Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide LIQUID ORAL 20070403 OTC MONOGRAPH FINAL part341 Portal Pharmaceutical CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE .6; 1.5; 2.75 mg/mL; mg/mL; mg/mL E 20171231 49963-210_a2c5b8a8-e7ca-4e6c-9432-538ca8294077 49963-210 HUMAN OTC DRUG Bronkids Chlorpheniramine/Dextromethorphan/Phenylephrine LIQUID ORAL 20090801 OTC MONOGRAPH FINAL part341 Portal Pharmaceutical CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 49963-381_148d8c18-9501-4127-9357-24372c7a84c3 49963-381 HUMAN OTC DRUG Brontuss SF-NR Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20111222 OTC MONOGRAPH FINAL part341 Portal Pharmaceutical DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 300; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 49963-532_c386c458-4510-437b-beb7-5d5ec607a732 49963-532 HUMAN OTC DRUG Bronkids Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20111010 OTC MONOGRAPH FINAL part341 Portal Pharmaceutical CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 10; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 49963-630_11108f5d-d9ea-498e-ba87-a6eff07dfa7f 49963-630 HUMAN OTC DRUG Clophed Chlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20100528 OTC MONOGRAPH FINAL part341 Portal Pharmaceutical CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 12.5; 100; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 49963-813_e1f6b972-4786-4c51-aaf8-181d6da0f5e8 49963-813 HUMAN OTC DRUG Brontuss SF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20100316 OTC MONOGRAPH FINAL part341 Portal Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 300; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 49963-913_5012801b-7bba-48d0-8636-68300642c6bd 49963-913 HUMAN OTC DRUG Brontuss DX Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20091124 OTC MONOGRAPH FINAL part341 Portal Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 49967-003_35da0fc7-528f-43f7-a88f-ba56ccae536c 49967-003 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 60 Melt In Sunscreen Milk Broad Spectrum SPF 60 Face and Body Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-005_da781855-a73f-4ae5-a3b8-6c5db87ced24 49967-005 HUMAN OTC DRUG Vichy Laboratoires Normaderm Daily Deep Cleansing Salicylic Acid GEL TOPICAL 20120201 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL N 20181231 49967-006_29102500-f316-49df-8b42-9b556a233f37 49967-006 HUMAN OTC DRUG Maybelline New York Instant Age Rewind Eraser Treatment Makeup SPF 18 Octinoxate LIQUID TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 1.5 mL/20mL E 20171231 49967-007_f07b2ab5-096f-453e-89df-fdcd26f81054 49967-007 HUMAN OTC DRUG Maybelline New York Instant Age Rewind Eraser Treatment Makeup Broad Spectrum SPF 18 Sunscreen Octinoxate LOTION TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 75 mg/mL N 20181231 49967-008_f0da8719-2002-4130-87f8-2daea16a666e 49967-008 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.8; 96; 28.8; 53.8; 34.6 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 49967-017_c507511a-5e4f-45bd-bdd6-809a5926c445 49967-017 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios SX Daily Moisturizing Sunscreen Broad Spectrum SPF 15 Avobenzone, Ecamsule and Octocrylene CREAM TOPICAL 20140729 NDA NDA021502 L'Oreal USA Products Inc AVOBENZONE; ECAMSULE; OCTOCRYLENE 20; 20; 100 mg/g; mg/g; mg/g N 20181231 49967-018_eaba598c-4b0a-4a3e-a4ce-853b91fc472a 49967-018 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Body Broad Spectrum SPF 50 Ultra Light Sunscreen Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 110 mg/mL N 20181231 49967-019_433ec4ec-284b-41ea-bc61-b8ab90874289 49967-019 HUMAN OTC DRUG Dermablend Quick Fix Concealer Titanium Dioxide CREAM TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 30 mg/g N 20181231 49967-020_8e6a42a3-9fe3-41b8-b3ed-adafda0f2e16 49967-020 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen Titanium Dioxide LOTION TOPICAL 20170130 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 110 mg/mL N 20181231 49967-021_72cc2ecb-2226-4576-9bf7-d14edec66b53 49967-021 HUMAN OTC DRUG Yves Saint Laurent Forever Youth Liberator Sunscreen Broad Spectrum SPF 15 Antiwrinkle Lift Plump Radiance Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 21; 35; 49 mg/mL; mg/mL; mg/mL N 20181231 49967-022_e8e1d2f1-2fc3-435a-8d6d-77111c43dad7 49967-022 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Effaclar BB Blur Broad Spectrum SPF 20 Sunscreen Titanium Dioxide CREAM TOPICAL 20150820 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 106.6 mg/mL N 20181231 49967-023_0cdcaaf2-367c-4b2a-ab5b-85d4afef039b 49967-023 HUMAN OTC DRUG La Roche Posay Laboratorie Dermatologique Effaclar Medicated Cleanser Salicylic Acid GEL TOPICAL 20140801 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 20 mg/mL N 20181231 49967-024_91257f65-8226-4407-ad72-eead08fdfcaf 49967-024 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Effaclar Clarifying Salicylic Acid SOLUTION TOPICAL 20140801 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL N 20181231 49967-027_6de9482c-ce7e-4a72-a8f4-b783c053fede 49967-027 HUMAN OTC DRUG Garnier UltraLift Transformer AntiAge Skin Corrector Broad Spectrum SPF 20 Sunscreen Octisalate and Octocrylene LOTION TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTISALATE; OCTOCRYLENE 49; 44 mg/mL; mg/mL N 20181231 49967-028_bea38b05-c62d-4979-a94f-743b8c743985 49967-028 HUMAN OTC DRUG Garnier Nutritioniste Skin Renew Radiance Moisture Lotion SPF 15 Ensulizole Octinoxate LOTION TOPICAL 20090801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 1.125; 5.62 mL/75mL; mL/75mL E 20171231 49967-029_48907ba7-385c-4d15-9636-f7320949ebf4 49967-029 HUMAN OTC DRUG La Roche-Posay Laboratoire Pharmaceutique Anthelios 60 Melt-In Sunscreen Lotion SPF 60 Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20090801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL E 20171231 49967-030_5a0e8828-8f6b-4fe4-8a0a-a848627408a8 49967-030 HUMAN OTC DRUG SkinCeuticals Daily Sun Defense Broad Spectrum SPF 20 Sunscreen Octinoate and Zinc Oxide CREAM TOPICAL 20060607 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 49967-031_922a1b4b-4f13-45cc-8c36-d53ab68cbb29 49967-031 HUMAN OTC DRUG LOreal Paris Advanced Suncare Quick Dry Sheer Finish 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.6; 87.8; 48.8; 59.2 mg/g; mg/g; mg/g; mg/g N 20181231 49967-032_6316ef1b-7408-4316-93b9-f38f12e96193 49967-032 HUMAN OTC DRUG La Roche-Posay Laboratoire Pharmaceutique Anthelios 60 Melt-In Sunscreen Milk SPF 60 Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20090801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.5; 22.5; 7.5; 7.5; 9 mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL E 20171231 49967-035_4dc1042d-9aa4-4c0c-a95e-7fae183c3734 49967-035 HUMAN OTC DRUG Garnier Clean Blackhead Eliminating Scrub Salicylic Acid GEL TOPICAL 20140101 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 20 mg/mL N 20181231 49967-037_40fa1bf4-9670-4338-9e46-f4eee1066c84 49967-037 HUMAN OTC DRUG Giorgio Armani ArmaniPrima Color Control Glow Moisturizer Broad Spectrum SPF 35 Sunscreen Octinoxate and Titanium Dioxide LOTION TOPICAL 20180115 OTC MONOGRAPH NOT FINAL part352 -L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 50; 19 mg/mL; mg/mL N 20191231 49967-038_0e0d6655-169f-4350-8440-e3484f54a900 49967-038 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 60 Face and Body Cooling Water Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-039_08392b29-af55-4473-91cb-1cc2093b8b0e 49967-039 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 45 Ultra Light Sunscreen Fluid Broad Spectrum SPF 45 Sunscreen Water Resistant 40 Minutes Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-041_bf8e4ceb-61c5-4a31-8d6e-759b09ba0f07 49967-041 HUMAN OTC DRUG Vichy Laboratoires Aqualia Thermal Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 60; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-045_e645ace1-d77e-4ca3-8b81-31579e4ef959 49967-045 HUMAN OTC DRUG Maybelline New York Instant Age Rewind Radiant Firming Makeup Broad Spectrum SPF 18 Sunscreen Octinoxate LOTION TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 45 mg/mL N 20181231 49967-047_af968aef-cccd-49a2-bf51-db69bc1fe2f5 49967-047 HUMAN OTC DRUG Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 50 Sunscreen Water Resistant 80 MInutes Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20150215 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-050_a3eef931-cd87-4ce6-b4ee-c94417491638 49967-050 HUMAN OTC DRUG SkinCeuticals Physical Eye UV Defense Sunscreen Titanium dioxide and Zinc oxide LOTION TOPICAL 20140418 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE; ZINC OXIDE 90; 40 mg/mL; mg/mL N 20181231 49967-052_59977a05-7261-4fb1-8a12-9bc8350d4c5e 49967-052 HUMAN OTC DRUG Matrix Biolage ScalpSync Antidandruff Pyrithione Zinc SHAMPOO TOPICAL 20140501 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49967-058_18a4a303-8ae9-4a97-b9e3-aff746147fbf 49967-058 HUMAN OTC DRUG Lancome Paris Imanance Broad Spectrum SPF 15 Sunscreen Octinoxate and Titanium Dioxide LOTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 60; 34 mg/mL; mg/mL N 20181231 49967-060_ffcb0095-2129-4cc0-b7a4-ca74467e7a05 49967-060 HUMAN OTC DRUG Dermablend Smooth Indulgence Concealer Titanium Dioxide LOTION TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 61 mg/mL N 20181231 49967-064_551f276a-ad56-4c24-a8fb-9ffae42546ab 49967-064 HUMAN OTC DRUG Yves Saint Laurent Le Teint Touche Eclat Illuminating Foundation Broad Spectrum SPF 19 Sunscreen Octinoxate LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 70 mg/mL N 20181231 49967-065_c64699b8-6bbe-408a-9862-d5626c1cc943 49967-065 HUMAN OTC DRUG Yves Saint Laurent Le Teint Touche Eclat Sunscreen Illuminating Foundation SPF 19 Octinoxate LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 2.1 mL/30mL N 20181231 49967-066_d764204d-8675-4485-b40f-89bd572a42dd 49967-066 HUMAN OTC DRUG SkinCeuticals Sport UV Defense Sunscreen Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 150; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-067_d4d5d821-34da-4d26-a2fc-3f2bc82700a3 49967-067 HUMAN OTC DRUG Dermablend Smooth Indulgence Foundation Titanium Dioxide LOTION TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 61 mg/mL N 20181231 49967-075_f40cb41f-058f-4c7c-b064-29183cf749e0 49967-075 HUMAN OTC DRUG La Roche Posay Laboratoire DermatologiqueEffaclar Duo Effaclar Duo Benzoyl peroxide LOTION TOPICAL 20120701 OTC MONOGRAPH FINAL part333D L'OREAL USA, INC. BENZOYL PEROXIDE 2.2 mg/40mL E 20171231 49967-076_a275ad66-5bc6-4f57-879e-8c6487c801ed 49967-076 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne Treatment Benzoyl peroxide LOTION TOPICAL 20120701 OTC MONOGRAPH FINAL part333D L'OREAL USA, INC. BENZOYL PEROXIDE 55 mg/mL N 20181231 49967-077_b3e55b25-2588-4d8d-9f55-7a0e7e927e5f 49967-077 HUMAN OTC DRUG SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 50 mg/mL; mg/mL N 20181231 49967-078_60a44f60-0897-4f90-b6a5-d4cddc570769 49967-078 HUMAN OTC DRUG Kiehls Since 1851 Activated Sun Protector For Body Broad Spectrum SPF 50 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-079_ca8c23a2-9705-4157-ac83-8bdd00103302 49967-079 HUMAN OTC DRUG LOreal Paris Youth Code Day Avobenzone Homosalate Octisalate Octocrylene CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.35; 2.25; 2.25; 3.15 g/45g; g/45g; g/45g; g/45g E 20171231 49967-080_13bd7c1d-8fbf-4d6f-bc18-831b010edc78 49967-080 HUMAN OTC DRUG Maybelline New York Dream Wonder Fluid Touch Foundation Broad Spectrum SPF 20 Sunscreen Octinoxate LOTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL N 20181231 49967-082_12634841-99c4-4fa5-a4d1-381e621e8231 49967-082 HUMAN OTC DRUG LOreal Paris Revitalift Triple Power Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-085_f8f3e929-0c4f-47ec-8805-a5e9963fcf6e 49967-085 HUMAN OTC DRUG La Roche Posay Anthelios 30 Ultralight Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.29; 17.16; 7.17; 10.01; 8.58 g/143g; g/143g; g/143g; g/143g; g/143g E 20171231 49967-087_6c7bf147-6b12-4fde-9b59-9376d893c119 49967-087 HUMAN OTC DRUG Vichy Laboratoires Ideal Capital Soleil 45 Sunscreen Broad Spectrum SPF 45 Water Resistant 80 Minutes Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20150520 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-088_daf8a5b0-c5d5-41f2-9fcf-989a55079428 49967-088 HUMAN OTC DRUG Vichy Laboratoire Capital Soleil SPF 60 Soft Sheer Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.5; 22.5; 7.5; 7.5; 9 mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL E 20171231 49967-089_a88609bc-0d95-4be5-b8a4-7b46d50eec6c 49967-089 HUMAN OTC DRUG Vichy Laboratoire Capital Soleil SPF 30 Soft Sheer Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.5; 7.5; 7.5; 10.5; 9 mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL E 20171231 49967-090_f36d4647-9237-49b5-b3f8-be8cb9f110a5 49967-090 HUMAN OTC DRUG La RochePosay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen Titanium dioxide LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 5.5 mL/50mL E 20171231 49967-092_9bcbe8cc-414b-430d-a2b4-aa4eba12a30d 49967-092 HUMAN OTC DRUG Garnier UltraLift SPF 30 Deep Wrinkle Day Avobenzone Homosalate Octisalate Octocrylene CREAM TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.44; .96; 2.4; 3.36 mL/48mL; mL/48mL; mL/48mL; mL/48mL E 20171231 49967-094_2a612854-ed7d-4efc-8c1b-39b1bc84397e 49967-094 HUMAN OTC DRUG LOreal Paris Skin Expertise Age Perfect Broad Spectrum SPF 20 Sunscreen BB Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL N 20181231 49967-095_d3d5987d-1f4d-4ee5-b142-5cfa0310d21d 49967-095 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 50 Daily Antiaging Primer with Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20120405 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.2; 4; 2; 2; 2.4 mL/40mL; mL/40mL; mL/40mL; mL/40mL; mL/40mL N 20181231 49967-097_ffe50d11-2709-4931-a9f5-08b70aaca549 49967-097 HUMAN OTC DRUG SkinCeuticals Blemish Plus Age Defense Acne Treatment Salicylic Acid LOTION TOPICAL 20050801 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 15 mg/mL N 20181231 49967-099_ac21bc86-ec4f-4b62-b94e-45847de721ac 49967-099 HUMAN OTC DRUG Kiehls Since 1851 Ultra Facial Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-105_7c568f28-5573-4f10-b4a0-97444fe9b979 49967-105 HUMAN OTC DRUG Dermablend Professional SkinPerfector Redness Reducing Primer Sunscreen Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 20; 33; 46 mg/mL; mg/mL; mg/mL N 20181231 49967-106_7a016f56-fbf2-4e5e-9056-2de1be5baa98 49967-106 HUMAN OTC DRUG Dermablend Professional SkinPerfector Blemish and Oil Clearing Primer Salicylic acid LOTION TOPICAL 20121001 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL N 20181231 49967-111_1457ebb5-feb8-4ccc-8d95-7b96b350ce4d 49967-111 HUMAN OTC DRUG Garnier SkinActive Clearly Brighter Brightening and Smoothing Daily Moisturizer Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 50 mg/mL; mg/mL; mg/mL N 20181231 49967-112_55de38f6-c72a-4cf8-8cbb-888a980bd749 49967-112 HUMAN OTC DRUG Garnier SkinActive Clearly Brighter AntiSun Damage Daily Moisturizer Broad Spectrum SPF 30 Sunscreen Avobenzone, Homoslate, Octisalate and Octocrylene LOTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; 1/mL; mg/mL; mg/mL N 20181231 49967-116_5c2c509b-dddc-4bec-b4b2-f0d10143ec68 49967-116 HUMAN OTC DRUG Lancome Paris La Base Pro Redness Corrector Broad Spectrum SPF 10 Sunscreen Neutralizing Makeup Base Octinoxate and Titanium Dioxide LOTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 30; 28.2 mg/mL; mg/mL N 20181231 49967-120_62378718-2f7f-4782-8079-d74dc1d2b4c6 49967-120 HUMAN OTC DRUG Giorgio Armani Regenessence High Lift SPF 15 Avobenzone Octisalate Octocrylene CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 3.5 mL/50mL; mL/50mL; mL/50mL E 20171231 49967-121_3e909d27-23c6-4e14-8cbf-ef8fb785e7d9 49967-121 HUMAN OTC DRUG Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 30 Sunscreen for Body Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone AEROSOL, SPRAY TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 70; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 49967-125_63d9bb35-7730-4a9c-85aa-cd4ae07f7752 49967-125 HUMAN OTC DRUG Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 50 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone AEROSOL, SPRAY TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 70; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 49967-126_4a92624d-6934-41a6-9dec-6b771f2b8638 49967-126 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Moisturizer Broad Spectrum SPF 20 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 47; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-128_7df19ac5-9984-4d3d-a759-08e11e4ef800 49967-128 HUMAN OTC DRUG Maybelline New York Pure Stay Powder Foundation Broad Spectrum SPF 15 Sunscreen Octinoxate POWDER TOPICAL 20020801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 40 mg/g N 20181231 49967-129_a111e5d1-9133-4759-9fcc-1db9d53393a6 49967-129 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Ultra Light Fluid Sunscreen Broad Spectrum SPF 60 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-130_66e7a421-fde3-4b61-887e-eb04187a51db 49967-130 HUMAN OTC DRUG LOreal Paris Skin Expertise Collagen Moisture Filler Daily Moisturizer Day Lotion SPF15 Ensulizole Octinoxate LOTION TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 1.08; 4.5 mL/60mL; mL/60mL E 20171231 49967-134_017ab6a5-4992-4aa3-b890-39709de0bff5 49967-134 HUMAN OTC DRUG Garnier Skin Renew Miracle Skin Perfector AntiAging BB Broad Spectrum SPF 15 Sunscreen Octinoxate and Titanium Dioxide CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 30; 36 mg/mL; mg/mL N 20181231 49967-135_be62eccc-97e2-497d-be2b-d9a2a4f7d632 49967-135 HUMAN OTC DRUG Yves Saint Laurent Forever Youth Liberator Broad Spectrum SPF 15 Sunscreen Fluid Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 21; 35; 49 mg/mL; mg/mL; mg/mL N 20181231 49967-137_2bd066d0-2e0d-4005-9703-1af2fff00bd7 49967-137 HUMAN OTC DRUG Lancome Paris Absolue Hand Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Anti Age Spot Unifying And Replenishing Treatment Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 20; 50; 100 mg/g; mg/g; mg/g N 20181231 49967-152_dc26e8a3-63ff-447a-b54e-b84e8fdddf12 49967-152 HUMAN OTC DRUG Giorgio Armani Designer Shaping Foundation Broad Spectrum SPF 20 Sunscreen Octinoxate and Titanium dioxide CREAM TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 40; 20 mg/mL; mg/mL N 20181231 49967-159_46c143f3-7155-40d7-a145-62f7c4c3f0b6 49967-159 HUMAN OTC DRUG LOreal Paris Dermo Expertise SPF 15 Active Daily Moisture Ensulizole Octinoxate LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 2.36; 8.26 mL/118mL; mL/118mL E 20171231 49967-166_953f3250-ed42-4f22-8fce-3edc0c7a1258 49967-166 HUMAN OTC DRUG Lancome Paris Absolue Precious Cells Sunscreen Repairing and Recovering Day Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20090801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/g; mg/g; mg/g N 20181231 49967-170_1715cf6e-2e76-4413-b8dc-f16adb118f42 49967-170 HUMAN OTC DRUG LOreal Paris Skin Expertise Age Perfect For Mature Skin Anti-Sagging Anti-Age Spot Hydrating Moisturizer Day Cream SPF 15 Ensulizole Octinoxate CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 1.19; 5.25 g/70g; g/70g E 20171231 49967-171_eee717ef-ab0a-42dc-a1a2-839cb53dfd16 49967-171 HUMAN OTC DRUG Garnier Skin Renew Miracle Skin Perfector Octinoxate CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 3 mL/75mL E 20171231 49967-182_9f919927-f9b2-42e9-ac6c-a32d30696b51 49967-182 HUMAN OTC DRUG Giorgio Armani Designer Lift Smoothing Firming Foundation Broad Spectrum SPF 20 Sunscreen Octinoxate and Titanium dioxide LOTION TOPICAL 20060801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 75; 19 mg/mL; mg/mL N 20181231 49967-184_0d340eba-ebe4-4630-84a4-148ea6b95b34 49967-184 HUMAN OTC DRUG Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 Sunscreen 24 Hour Moisturization Antioxidant and Vitamin Enriched Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20051001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL N 20181231 49967-187_3f7facf8-6c91-459f-a24d-3c58aee3c3e7 49967-187 HUMAN OTC DRUG Lancome Paris Bienfait MultiVital Eye SPF 28 Sunscreen 24 Hour Moisturization Antioxidant and Vitamin Enriched Octinoxate and Titanium Dioxide CREAM TOPICAL 20081101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 75; 50 mg/g; mg/g N 20181231 49967-194_412a21c0-0015-41d3-a29b-a62b131fac55 49967-194 HUMAN OTC DRUG Lancome Paris Visionnaire Broad Spectrum SPF 20 Sunscreen Advanced Multi Correcting All Skin Types Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/g; mg/g; mg/g N 20181231 49967-195_400a7251-f893-491e-b5b9-812a6572821d 49967-195 HUMAN OTC DRUG Lancome Paris Absolue Premium Bx Absolute Replenishing SPF 15 Avobenzone Octisalate Octocrylene CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 5; 2.5; 4 g/50g; g/50g; g/50g E 20171231 49967-196_d3e31672-9eab-4626-b5d4-744fdadb5e5f 49967-196 HUMAN OTC DRUG Maybelline New York Master Prime By Face Studio Primer Broad Spectrum SPF 30 Sunscreen Octinoxate LOTION TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc OCTINOXATE 75 mg/mL N 20181231 49967-201_604b10cb-eb85-4be3-9ef7-8cc17ac0981c 49967-201 HUMAN OTC DRUG CeraVe Developed with Dermatologists Healing Lip Balm Broad Spectrum SPF 30 Sunscreen Avobenzone, Dimethicone, Homosalate, Octisalate and Octocrylene STICK TOPICAL 20170831 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; DIMETHICONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 10; 100; 50; 100 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 49967-205_6f7745ef-00d1-4d80-b620-cd02645a5fe4 49967-205 HUMAN OTC DRUG Lancome Paris Teint Visionnaire Skin Correcting Makeup Duo Foundation Broad Spectrum SPF 20 Octinoxate LOTION TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 75 mg/mL N 20181231 49967-206_11496439-4310-44ae-9dff-b47eb0ea5eed 49967-206 HUMAN OTC DRUG Giorgio Armani Regenessence High Lift Muti Firming Rejuvenating Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL N 20181231 49967-207_d42d1320-5472-4702-86f0-91c486dc3c2f 49967-207 HUMAN OTC DRUG LOreal Paris Youth Code Dark Spot Corrector Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/g; mg/g; mg/g; mg/g N 20181231 49967-208_feb4a445-9e91-4c58-9b39-edc0674ef26e 49967-208 HUMAN OTC DRUG Vichy Laboratoires Capital Soleil 30 Broad Spectrum SPF 30 Sunscreen Luxurious Protective Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone OIL TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 70; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-213_041d7131-5c9f-4290-8928-604994308822 49967-213 HUMAN OTC DRUG Giorgio Armani lasting silk UV compact foundation Octinoxate and Titanium Dioxide POWDER TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 30; 86 mg/g; mg/g E 20171231 49967-222_a5b1ba1d-8a18-4766-9243-e4a055198212 49967-222 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 45 Ultra Light Sunscreen Fluid Water Resistant 40 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-229_7a672eef-693f-4bf0-8df1-6fc782187540 49967-229 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 30 Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.64; 4.4; 4.4; 6.16; 5.28 mL/88mL; mL/88mL; mL/88mL; mL/88mL; mL/88mL E 20171231 49967-232_bc5df22b-6723-47aa-a920-ccbf1c4d9a64 49967-232 HUMAN OTC DRUG Vichy Laboratoires Normaderm Daily Gentle Cleanser Salicylic Acid CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL N 20181231 49967-239_19e56c0f-ea4f-4db6-8c8c-755dea258bcf 49967-239 HUMAN OTC DRUG Dermablend Professional Blurring Mousse Camo Foundation Broad Spectrum SPF 25 Sunscreen Titanium dioxide LOTION TOPICAL 20160523 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 104 mg/mL N 20181231 49967-243_d227cd29-2560-4d7a-9e20-e75a730b10b5 49967-243 HUMAN OTC DRUG Giorgio Armani Lasting Silk UV Foundation Broad Spectrum SPF 20 Sunscreen Octinoxate and Titanium dioxide LOTION TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 30; 62 mg/mL; mg/mL N 20181231 49967-246_bddfe622-9694-4e36-805e-6593085bd35d 49967-246 HUMAN OTC DRUG Garnier SkinActive Ultra Lift AntiWrinkle Firming Daily Moisturizer Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 30 mg/mL; mg/mL; mg/mL N 20181231 49967-250_ac29f2c8-e523-4719-88ca-a02452e3fe3f 49967-250 HUMAN OTC DRUG Lancome Paris Absolue Premium Bx Broad Spectrum SPF 15 Sunscreen Absolute Replenishing Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 30; 80 mg/mL; mg/mL; mg/mL N 20181231 49967-264_152cb574-13b4-48ff-9fa8-c34f7b61b43f 49967-264 HUMAN OTC DRUG Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 Sunscreen Titanium Dioxide CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 11.5 mg/mL N 20181231 49967-269_0b17dd73-3eb6-4938-9951-53d59fe16796 49967-269 HUMAN OTC DRUG Lancome Paris Teint Idole Ultra Makeup Broad Spectrum SPF 21 Octinoxate and Titanium Dioxide STICK TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 20; 19 mg/g; mg/g N 20181231 49967-272_98384153-6258-48da-8aab-604cef6bc45c 49967-272 HUMAN OTC DRUG Kiehls Since 1851 CrossTerrain Antiperspirant Deodorant 24 Hour Strong Dry Aluminum Chlorohydrate STICK TOPICAL 20100601 OTC MONOGRAPH FINAL part350 L'Oreal USA Products Inc ALUMINUM CHLOROHYDRATE 15 g/75g N 20181231 49967-279_d65bec5f-0428-46ba-80a9-9ffa201ccb56 49967-279 HUMAN OTC DRUG Kiehls Since 1851 Facial Fuel UV Guard Fast Absorbing Sunscreen for Men SPF 50 Plus Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL E 20171231 49967-280_f6d8c1c4-8fcf-4d26-8b9a-1494a9981d7a 49967-280 HUMAN OTC DRUG LOreal Paris Magic Nude Bare Skin Perfecting Makeup OCTINOXATE LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL N 20181231 49967-288_ec6e0f0d-1092-42af-aac0-e797dc231092 49967-288 HUMAN OTC DRUG Dermablend Leg and Body Cover Titanium Dioxide LOTION TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 10 mg/mL N 20181231 49967-295_a069dbcf-2e09-4548-bd01-e99ca777ad05 49967-295 HUMAN OTC DRUG LOreal Paris Men Expert Comfort Max Hydra Energetic After Shave Balm Broad Spectrum SPF 15 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20131219 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-301_1ab036fe-87d3-4a3d-8a07-63d3715d6b71 49967-301 HUMAN OTC DRUG CeraVe Developed with Dermatologists Heal and Protect Balm Dimethicone STICK TOPICAL 20171001 OTC MONOGRAPH FINAL part347 L'Oreal USA Products Inc DIMETHICONE 10 mg/g N 20181231 49967-311_9028aa46-2554-48e8-936c-6cd63bd4601a 49967-311 HUMAN OTC DRUG Dermablend Cover Titanium Dioxide CREAM TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 30 mg/g N 20181231 49967-319_d3c0eb7b-79f5-4167-8aab-7f0a24ec3d72 49967-319 HUMAN OTC DRUG Garnier Skin Renew Dark Spot Hand Treatment Broad Spectrum SPF 30 Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL N 20181231 49967-324_a217c36e-2346-475f-a764-5ff83d5f5204 49967-324 HUMAN OTC DRUG LOreal Paris Advanced Suncare Silky Sheer 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 50; 70; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-325_9eef55b0-2c62-4e74-affe-60a53b0ffbb9 49967-325 HUMAN OTC DRUG LOreal Paris Advanced Suncare Silky Sheer 50 Plus Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-326_aa396f1c-7090-4b50-a498-5cc0bb69b88b 49967-326 HUMAN OTC DRUG Lancome Paris Renergie Lift Multi Action Broad Spectrum SPF 15 Sunscreen Lifting and Firming for Dry Skin Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/g; mg/g; mg/g N 20181231 49967-327_e71c28ea-a863-4b3f-a5fa-9f0783621c9f 49967-327 HUMAN OTC DRUG LOreal Paris Advanced Suncare Silky Sheer Face 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-328_638d1aa6-a0d8-4b72-940b-49f63bf9244d 49967-328 HUMAN OTC DRUG LOreal Paris Advanced Suncare Silky Sheer Face 50 Plus Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-330_a1762f07-7ca7-4598-bbba-39d1ccf2b9b1 49967-330 HUMAN OTC DRUG Dermablend Professional Smooth Camo Medium Coverage Foundation Broad Spectrum SPF 25 Sunscreen Titanium Dioxide LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 68 mg/mL N 20181231 49967-332_8b243497-5497-4ba5-b294-a16e6ffe3a77 49967-332 HUMAN OTC DRUG Vichy Laboratoires Normaderm Triple Action 3 in 1 Cleanser Salicylic Acid CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 5 mg/mL N 20181231 49967-333_c46bd6b2-f95c-46a6-bc56-2811628ba80a 49967-333 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Sheer 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 70 mg/g; mg/g; mg/g; mg/g N 20181231 49967-334_c23eb8ba-b192-4b6a-a2ea-59abba82918b 49967-334 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Sheer 50 Plus Broad Spectrum SPF 50 Plus Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 70; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 49967-343_1a90fbf4-d882-453c-9d8d-7336eedd9b9d 49967-343 HUMAN OTC DRUG LOreal Paris Hair Expert Ever Fresh Sulfate Free Antidandruff Pyrithione Zinc SHAMPOO TOPICAL 20161101 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49967-344_d1e15a7b-b781-4843-b34f-b704e930acbc 49967-344 HUMAN OTC DRUG Urban Decay Naked Skin One and Done Hybrid Complexion Perfector Broad Spectrum SPF 20 Octinoxate and Zinc Oxide LOTION TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; ZINC OXIDE 75; 34 mg/mL; mg/mL N 20181231 49967-345_415c896c-044d-4e07-b698-2377e9ec4fe9 49967-345 HUMAN OTC DRUG Garnier Moisture Rescue Lightweight UV Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 50 mg/mL; mg/mL; mg/mL N 20181231 49967-349_d15af666-e3a6-4d2d-851a-95f0604b46de 49967-349 HUMAN OTC DRUG Giorgio Armani Power Fabric Long Wear High Cover Foundation Broad Spectrum SPF 25 Sunscreen Octinoxate LOTION TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc. OCTINOXATE 67 mg/mL N 20181231 49967-352_e2391223-6609-4982-9dca-d2de94208504 49967-352 HUMAN OTC DRUG Yves Saint Laurent Forever Youth Liberator Avobenzone Octisalate Octocrylene CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.05; 1.75; 2.45 mL/50mL; mL/50mL; mL/50mL N 20181231 49967-357_93034a24-a2c3-490f-98d3-b4ae9d6030da 49967-357 HUMAN OTC DRUG LOreal Paris Sublime Sun 30 Crystal Clear Sunscreen Mist Broad Spectrum SPF 30 Water Resistant Avobenzone, Homosalate, Octisalate and Octocrylene AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 70 mg/g; mg/g; mg/g; mg/g N 20181231 49967-358_d7f55afc-6f68-4bf6-adc7-041f5441aed0 49967-358 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 30 Crystal Clear Mist Avobenzone Homosalate Octisalate Octocrylene AEROSOL, SPRAY TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3.75; 12.5; 6.25; 8.75 mL/125mL; mL/125mL; mL/125mL; mL/125mL E 20171231 49967-359_6ff4609d-932a-4d25-9a42-c89c7c9502cc 49967-359 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 50 Plus Crystal Clear Mist Avobenzone Homosalate Octisalate Octocrylene Oxybenzone AEROSOL, SPRAY TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.75; 18.75; 6.25; 8.75; 8.75 mL/125mL; mL/125mL; mL/125mL; mL/125mL; mL/125mL E 20171231 49967-361_63b1b0bd-c5de-4063-99b6-ee4be4fc3a24 49967-361 HUMAN OTC DRUG LOreal Paris Sublime Bronze Summer Express Wash Off Face Bronzer Broad Spectrum SPF 20 Sunscreen Homosalate, Octisalate, Octocrylene and Titanium Dioxide CREAM TOPICAL 20150925 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc HOMOSALATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 60; 50; 70; 31 mg/mL; mg/mL; mg/mL; 1/mL N 20181231 49967-362_b23f865a-9ab0-4360-b8e2-937b60acb234 49967-362 HUMAN OTC DRUG Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 20 Sunscreen Octinoxate LOTION TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL N 20181231 49967-369_a4966e4b-bd68-41f2-a00a-74df690a5651 49967-369 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 50 Plus Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.64; 13.2; 4.4; 4.4; 5.28 mL/88mL; mL/88mL; mL/88mL; mL/88mL; mL/88mL E 20171231 49967-370_efb5a14e-3837-4699-94db-d3ae57ef7345 49967-370 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios AOX Daily Antioxidant Serum Broad Spectrum SPF 50 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.8; 96; 28.8; 53.8; 34.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-371_d25ddcee-d093-472a-a843-d004d6445a3c 49967-371 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 50 Plus Liquid Silk Sunshield For Face Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL E 20171231 49967-372_bec766c1-6854-45e2-87d8-e12a1a23d9e6 49967-372 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 30 Hydra Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.6; 14.4; 6; 8.4; 7.2 g/120g; g/120g; g/120g; g/120g; g/120g E 20171231 49967-373_da38ae12-0735-4bde-8047-a8b18f216322 49967-373 HUMAN OTC DRUG LOreal Paris Sublime Sun Advanced Sunscreen SPF 50 Plus Hydra Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.6; 18; 6; 8.4; 7.2 g/120g; g/120g; g/120g; g/120g; g/120g E 20171231 49967-374_f8b6a46e-2598-434e-a7fd-e2356981acd6 49967-374 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face and Body Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-376_47d68a93-741f-478a-a4ab-4aee484346ec 49967-376 HUMAN OTC DRUG Yves Saint Laurent Forever Light Creator CC Primer Color Correcting Primer Broad Spectrum SPF 35 Sunscreen Octinoxate and Titanium Dioxide LOTION TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc. OCTINOXATE; TITANIUM DIOXIDE 50; 63 mg/mL; mg/mL N 20181231 49967-382_db4d13f8-fd4b-4642-b4a9-13c889b63c34 49967-382 HUMAN OTC DRUG Kiehls Since 1851 CrossTerrain UV Skin Protector SPF 50 Water and Sweat Resistant Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone OINTMENT TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.2; 4; 2; 3; 2 g/40g; g/40g; g/40g; g/40g; g/40g N 20181231 49967-384_d03fe21a-7585-4fa5-8b08-6d210cca7ead 49967-384 HUMAN OTC DRUG Lancome Paris BB Bienfait Teinte Beauty Balm Broad Spectrum SPF 30 Sunscreen Octinoxate and Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 75; 58 mg/mL; mg/mL N 20181231 49967-388_0aa34392-51d9-4eb9-b9ec-bc12fd2e9e15 49967-388 HUMAN OTC DRUG Mizani Scalp Care Antidandruff Pyrithione Zinc SHAMPOO TOPICAL 20080601 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49967-389_f55e9245-4681-4551-9d9d-0617a10ac422 49967-389 HUMAN OTC DRUG Mizani Scalp Care Conditioner Antidandruff Conditioner Pyrithione Zinc LOTION TOPICAL 20080601 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49967-392_0374ac05-4607-4657-b0bd-82091a3f5be1 49967-392 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 30 Cooling Water Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 22.4; 80; 24; 44.8; 28.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-403_3ad26dcb-7bbf-45d0-a088-4d02628f4a46 49967-403 HUMAN OTC DRUG Yves Saint Laurent All Hours Primer Broad Spectrum SPF 18 Sunscreen Octinoxate LOTION TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 65 mg/mL N 20181231 49967-406_64d4978d-95cf-44fe-9198-2d6e55cabc8e 49967-406 HUMAN OTC DRUG Yves Saint Laurent Touche Eclat All in One Glow Instant Complexion Enhancer Broad Spectrum SPF 23 Sunscreen Octinoxate LOTION TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL N 20181231 49967-409_93f0fa46-e104-4fec-9f85-481350631783 49967-409 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Mineral Defense Broad Spectrum SPF 50 Plus Sunscreen Titanium Dioxide LOTION TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 150 mg/mL N 20181231 49967-410_27f888e2-db42-45bf-be93-f0d724b0a64f 49967-410 HUMAN OTC DRUG Kiehls Since 1851 Super Multi Corrective Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-411_03dd8a55-eed4-4ce4-9dc2-60a3bd720013 49967-411 HUMAN OTC DRUG Vichy Laboratoires Normaderm Beautifying Anti Acne Care 24 H Hydrating Acne Treatment Salicylic acid LOTION TOPICAL 20160101 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 15 mg/mL N 20181231 49967-413_fbb96945-1b89-4151-99d5-2f87134982e7 49967-413 HUMAN OTC DRUG SkinCeuticals Ultimate UV Defense Broad Spectrum SPF 30 Sunscreen Octinoxate and Zinc Oxide CREAM TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; ZINC OXIDE 75; 70 mg/mL; mg/mL N 20181231 49967-422_f33bf301-4d3d-47bc-a80a-897120529a82 49967-422 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Rosaliac Daily Complete Tone Correcting Broad Spectrum SPF 30 Sunscreen CC Octinoxate, Octisalate, Octocrylene and Titanium Dioxide CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 30; 35; 45; 62 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-423_2430c070-d2be-4ea1-b416-da520a50a94b 49967-423 HUMAN OTC DRUG Lancome Paris Teint Idole Ultra Cushion Broad Spectrum SPF 50 Sunscreen Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 50; 105.9 mg/g; mg/g N 20181231 49967-425_59a0993f-d504-4bfb-879b-1da8321fe7e7 49967-425 HUMAN OTC DRUG LOreal Paris True Match Naturale gentle mineral makeup Broad Spectrum SPF 19 Titanium Dioxide POWDER TOPICAL 20060701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 100 mg/g N 20181231 49967-427_941858bb-8672-421f-8fd8-d5225e9480c4 49967-427 HUMAN OTC DRUG Maybelline New York Dream Nude Airfoam Air Infused Makeup Sunscreen Broad Spectrum SPF 16 Octinoxate, Octisalate and Octocrylene AEROSOL, FOAM TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; OCTISALATE; OCTOCRYLENE 71.2; 23.8; 9.5 mg/g; mg/g; mg/g N 20181231 49967-428_cff13883-e1c9-48a4-9ebb-f84fead0514b 49967-428 HUMAN OTC DRUG Maybelline New York Dream Nude Airfoam Air Infused Foundation SPF 16 Octinoxate Octisalate Octocrylene AEROSOL, FOAM TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; OCTISALATE; OXYBENZONE 3.2752; 1.0948; .437 g/46g; g/46g; g/46g E 20171231 49967-432_6f7e10d7-b9f6-4f6b-95c0-d85498fe9b8f 49967-432 HUMAN OTC DRUG Giorgio Armani Crema Nera Extrema Essential Defense Fluid Broad Spectrum SPF 14 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20170331 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 70; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-439_9fcb3259-7956-4709-b5dc-3ba19ae0d019 49967-439 HUMAN OTC DRUG Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry Skin Octinoxate LIQUID TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 70 mg/mL N 20191231 49967-441_cf3144ee-4421-4595-9031-1842410367e7 49967-441 HUMAN OTC DRUG Garnier SkinActive Moisture Rescue Actively Hydrating Daily Fragrance Free Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 50 mg/mL; mg/mL; mg/mL N 20181231 49967-444_2fcdcbec-bc0f-486c-b239-4f5e5d283080 49967-444 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions Super Fluid UV Defense Ultra Light Sunscreen SPF 50 Plus Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL N 20181231 49967-445_ace0402a-c529-42f7-865a-077f72a23f69 49967-445 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions Skin Tone Correcting and Beautifying BB Sunscreen Homosalate, Octisalate, Octocrylene and Titanium dioxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc HOMOSALATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 100; 50; 50; 45 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-452_eeededf6-b965-49eb-bbfd-3a8fa8c12eb1 49967-452 HUMAN OTC DRUG Maybelline New York Baby Lips Moisturizing Lip Balm SPF 20 Octinoxate Octisalate LIPSTICK TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; OCTISALATE .33; .132 g/4.4g; g/4.4g N 20181231 49967-453_e5425723-8a7e-49d8-af21-2b0d7921b69d 49967-453 HUMAN OTC DRUG Maybelline New York Baby Lips Peppermint Moisturizing Lip Balm SPF 20 Sunscreen Octinoxate and Octisalate LIPSTICK TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; OCTISALATE 75; 30 mg/g; mg/g N 20181231 49967-456_b4e2189b-844f-4f77-b43e-655eb6e52042 49967-456 HUMAN OTC DRUG Lancome Paris Bienfait MultiVital Broad Spectrum SPF 30 Sunscreen Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20060701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/g; mg/g; mg/g N 20181231 49967-457_35b96198-786e-456f-b428-6845319defd3 49967-457 HUMAN OTC DRUG Garnier Nutritioniste Moisture Rescue Lightweight UV SPF 15 Ensulizole Octinoxate LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 2; 10 mL/133mL; mL/133mL E 20171231 49967-458_e228ded8-c08f-4595-809e-84ad5face819 49967-458 HUMAN OTC DRUG LOreal Paris Revitalift Antiwrinkle Plus Firming SPF 18 Sunscreen Day Moisturizer Ensulizole and Octinoxate CREAM TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 20; 75 mg/g; mg/g N 20181231 49967-472_f3da2da9-8bb5-4dbe-b60f-2261967b6cf6 49967-472 HUMAN OTC DRUG SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 Sunscreen Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 40 mg/mL; mg/mL N 20181231 49967-475_bcb31086-feec-421c-b1d8-2972f1c52f0c 49967-475 HUMAN OTC DRUG LOreal Paris True Match Lumi Healthy Luminous Makeup Broad Spectrum SPF 20 Octinoxate LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 70 mg/mL N 20181231 49967-479_bb68d4f6-f940-4cf9-8463-04bc4dd40b1e 49967-479 HUMAN OTC DRUG Ralph Lauren Romance Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20120701 OTC MONOGRAPH FINAL part350 L'Oreal USA Products Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 1.2 g/75g N 20181231 49967-483_b07afc2e-2d2e-4785-bbc3-4b62c6333461 49967-483 HUMAN OTC DRUG Kerastase Specifique Bain Exfoliant Hydratant Pyrithione Zinc SHAMPOO TOPICAL 20120701 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc PYRITHIONE ZINC 10 mg/mL E 20171231 49967-489_2fb6153d-ab24-411d-a1db-8092d6190813 49967-489 HUMAN OTC DRUG Maybelline New York Baby Lips Dr Rescue Medicated Balm Menthol LIPSTICK TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 L'Oreal USA Products Inc MENTHOL 5 mg/g N 20181231 49967-495_3772f9d4-9bbf-4d14-814a-690b85fa6ce7 49967-495 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions Acne Blemish Control Daily Skin Clearing Treatment Salicylic Acid LOTION TOPICAL 20081101 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 15 mg/mL N 20181231 49967-501_47622cc0-aa2d-48f6-9692-02c42e971e66 49967-501 HUMAN OTC DRUG Kiehls Since 1851 Broad Spectrum SPF 30 Sunscreen Powerful Wrinkle Reducing Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 27; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-502_b9d9bc33-e470-4324-8ddc-cb9f16379589 49967-502 HUMAN OTC DRUG Lancome Paris High Resolution Refill 3X Triple Action Renewal Anti Wrinkle Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 30 mg/g; mg/g; mg/g N 20181231 49967-503_1e713f04-5ac0-4747-9fe5-a3fecc578b5c 49967-503 HUMAN OTC DRUG Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Octinoxate and Titanium Dioxide LIQUID TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 70; 17 mg/mL; mg/mL N 20181231 49967-504_2d94cb50-1697-4d8a-89f4-2a7e9b29ba4f 49967-504 HUMAN OTC DRUG LOreal Paris Skin Expert Revitalift Bright Reveal Brightening Day Moisturizer Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-505_eb643342-e048-4372-83d1-222af306d07f 49967-505 HUMAN OTC DRUG Yves Saint Laurent Rouge Pur Couture Pure Colour Satiny Radiance Octinoxate LIPSTICK TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .076 g/3.8g E 20171231 49967-506_20af29ee-db79-4b18-a707-a06e164b068c 49967-506 HUMAN OTC DRUG Lancome Paris Teint Miracle Lit From Within Makeup Broad Spectrum SPF 15 Sunscreen Octinoxate LIQUID TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL N 20181231 49967-507_2a39dd85-3b56-4a22-83b9-67eba16e6318 49967-507 HUMAN OTC DRUG LOreal Paris Age Perfect Hydra Nutrition Instant Glow Daily Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene OIL TOPICAL 20150921 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.6; 87.8; 48.8; 59.2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-513_c6391f86-f486-4c63-80bb-782b41726316 49967-513 HUMAN OTC DRUG VICHY LABORATOIRES DERMAFINISH CORRECTIVE FOUNDATION TITANIUM DIOXIDE LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 156.752 mg/mL N 20181231 49967-516_3127f5d1-21a0-4381-8eda-7bdeb899be6d 49967-516 HUMAN OTC DRUG Lancome Teint Miracle Lit from within Makeup SPF 15 Sunscreen Octinoxate LIQUID TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .9 mL/30mL E 20171231 49967-517_7ecab4ac-f9fb-43ec-8f4a-a84bbcfb9fef 49967-517 HUMAN OTC DRUG CeraVe Developed with Dermotologists Ultra Light Moisturizing Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20180122 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 49967-521_a0b0b7f3-bb21-4d0b-a927-2df1151e6259 49967-521 HUMAN OTC DRUG Yves Saint Laurent Terre Saharienne Bronzing Octinoxate POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .6 g/10g E 20171231 49967-524_dbcde648-fa77-4110-ba60-fc4c36f13f5d 49967-524 HUMAN OTC DRUG Maybelline New York Baby Lips Quenched Moisturizing Lip Balm SPF 20 Sunscreen Octinoxate and Octisalate LIPSTICK TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; OCTISALATE 75; 30 mg/g; mg/g N 20181231 49967-542_15b9ddb9-8c7c-428c-81cf-bc5bf40ea3e4 49967-542 HUMAN OTC DRUG Lancome Bienfait UV SPF 50 Plus Super Fluid Facial Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL E 20171231 49967-549_a7dd18e5-3edb-4bd6-8871-9fd9a249cb49 49967-549 HUMAN OTC DRUG Lancome Paris Star Bronzer Long Lasting Bronzer SPF 15 Octinoxate POWDER TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .975 g/13g E 20171231 49967-553_5a52baf6-bbd9-4ddd-9804-e2a8e9a7b7ec 49967-553 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Clear Cool 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.6; 87.8; 48.8; 59.2 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 49967-554_059788ae-c7c2-4ffa-98b7-618ea402f10b 49967-554 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Clear Cool 50 Plus Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 49967-555_bb58310d-e3c7-4a50-9c61-d2961f242134 49967-555 HUMAN OTC DRUG LOreal Paris Advanced Suncare Silky Sheer Face 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20131220 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.6; 87.8; 48.8; 59.2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-556_eae45c4c-2586-43df-85ca-578c863855d7 49967-556 HUMAN OTC DRUG LOreal Paris Advanced Suncare Silky Sheer BB Face 50 Plus Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20131220 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-561_22d5a903-5f4e-4840-a5be-c73039d41dd6 49967-561 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions Clearly Corrective Dark Circle Perfector Broad Spectrum SPF 30 Sunscreen Titanium Dioxide LOTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc TITANIUM DIOXIDE 78.5 mg/mL N 20181231 49967-563_e6d59fa0-e0b3-4890-86cc-0a707fa602fb 49967-563 HUMAN OTC DRUG Giorgio Armani Maestro UV Skin Defense Primer Broad Spectrum SPF 50 Sunscreen Avobenzone, Octinoxate and Octisalate LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 74.9; 50 mg/mL; mg/mL; mg/mL N 20181231 49967-564_affb6a5c-31c5-4f06-932e-5a85dd5aa1e4 49967-564 HUMAN OTC DRUG Lancome Tropiques Minerale Mineral Smoothing Pressed Bronzer SPF 15 Sunscreen Octinoxate POWDER TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .75 g/10g E 20171231 49967-575_62a5c777-5528-4938-8e77-e968ff49467e 49967-575 HUMAN OTC DRUG Giorgio Armani Face Fabric Second Skin Nude Makeup Broad Spectrum SPF 12 Sunscreen Octinoxate LOTION TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 20 mg/mL N 20181231 49967-578_3aeb06a1-2ce1-445a-a7b5-47d858299e6a 49967-578 HUMAN OTC DRUG Lancome Paris City Miracle Broad Spectrum SPF 50 Sunscreen CC Homosalate, Octisalate, Octocrylene and Titanium Dioxide CREAM TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc HOMOSALATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 100; 50; 50; 16 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-583_9908ca14-5b5d-423b-b4be-69701dcc4584 49967-583 HUMAN OTC DRUG Kiehls Since 1851 Facial Fuel Energizing Moisture Treatment for Men Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 50 mg/mL; mg/mL; mg/mL N 20181231 49967-584_56cb3116-f888-43e5-b12d-53aebca1fc02 49967-584 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20161221 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-585_9e90e912-37d7-4422-8041-222a0dbba752 49967-585 HUMAN OTC DRUG Giorgio Armani Luminessence CC Color Control Bright Moisturizer Broad Spectrum SPF 35 Sunscreen Octinoxate and Titanium Dioxide LOTION TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part352 -L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 50; 18.5 mg/mL; mg/mL N 20181231 49967-593_99c4619c-a118-47fb-a7a2-74bff18d5f55 49967-593 HUMAN OTC DRUG Yves Saint Laurent Forever Youth Liberator Ensulizole Octinoxate LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE 1; 3.745 mL/50mL; mL/50mL E 20171231 49967-595_4a481259-f2f5-45c6-a009-39f4a3a0d5be 49967-595 HUMAN OTC DRUG Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 Sunscreen Titanium dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 110 mg/mL N 20181231 49967-596_84899a0c-0868-40b3-a079-3df252aeda5e 49967-596 HUMAN OTC DRUG Lancome Paris Absolue Makeup Broad Spectrum SPF 20 Sunscreen Absolute Replenishing Makeup for Dry and Very Dry Skin Octinoxate CREAM TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 75 mg/mL N 20181231 49967-599_60b6f9d6-17e3-4190-9ee7-f76f18e662d5 49967-599 HUMAN OTC DRUG Giorgio Armani Maestro Glow Nourishing Fusion Makeup Broad Spectrum SPF 30 Sunscreen Octinoxate LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 50 mg/mL N 20181231 49967-601_afd04fc5-1457-4e28-9c67-9e717cb9c4b7 49967-601 HUMAN OTC DRUG CeraVe Developed with Dermatologists Psoriasis Cleanser Salicylic Acid LOTION TOPICAL 20170818 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc SALICYLIC ACID 20 mg/mL N 20181231 49967-605_82cc5529-1725-4383-be3f-36adb41cc905 49967-605 HUMAN OTC DRUG em michelle phan the everything tinted makeup cc Titanium Dioxide CREAM TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 11.5 mg/mL E 20171231 49967-610_3578c6ad-3ebc-4bf9-b560-224fa66dcfe7 49967-610 HUMAN OTC DRUG LOreal Paris Visible Lift CC Broad Spectrum SPF 20 Light Medium Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL N 20181231 49967-611_abddabd8-f5d0-48c8-8440-55f1bd096142 49967-611 HUMAN OTC DRUG LOreal Paris Visible lift Medium Deep CC Broad Spectrum SPF 20 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL N 20181231 49967-618_df5493ba-1575-4d02-b39b-39decb8e421b 49967-618 HUMAN OTC DRUG Kiehls Since 1851 Blue Herbal Acne Cleanser Treatment Salicylic Acid LOTION TOPICAL 20170301 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 15 mg/mL N 20181231 49967-621_f1af802a-86a5-472f-bb20-c9b0ba4931e4 49967-621 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief Oatmeal CREAM TOPICAL 20171121 OTC MONOGRAPH FINAL part347 L'Oreal USA Products Inc OATMEAL 10 mg/mL N 20181231 49967-622_e12eb676-8748-402b-9d22-10e8667ce004 49967-622 HUMAN OTC DRUG Urban Decay Urban Defense Complexion Primer Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 46 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-626_2fbffc17-58f3-47e1-8929-cf223dc04474 49967-626 HUMAN OTC DRUG Yves Saint Laurent Top Secrets All In One BB Octinoxate CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 74.9 mg/mL N 20181231 49967-627_e1d4293a-2c31-4921-8255-1d3b78a71e05 49967-627 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Dry 15 Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene SPRAY TOPICAL 20131220 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL E 20171231 49967-628_89fb49ab-1922-42a2-bf89-e73d953c5d79 49967-628 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Dry 30 Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene SPRAY TOPICAL 20131223 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 49967-629_a6077557-0bb1-438f-88e0-208d89078261 49967-629 HUMAN OTC DRUG LOreal Paris Advanced Suncare Invisible Protect Dry 50 Plus Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20131223 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 70; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-631_005196f7-52ae-4e44-b0ef-9d5329413484 49967-631 HUMAN OTC DRUG Kiehls Since 1851 Activated Sun Protector for Face Broad Spectrum SPF 50 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-633_3ea74a60-a63f-4714-86a5-d07d0c98403c 49967-633 HUMAN OTC DRUG Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Lift and Firming Face and Neck All Skin Types Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20161227 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/g; mg/g; mg/g N 20191231 49967-636_bd80ead6-2948-4972-aa39-b528f7b127c8 49967-636 HUMAN OTC DRUG Lancome Paris Nude Miracle Broad Spectrum SPF 15 Sunscreen Octinoxate LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL N 20181231 49967-641_0972d6ff-bb8a-4f01-97c3-3b0c195295db 49967-641 HUMAN OTC DRUG Lancome Paris Renergie Lift Multi Action All Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/g; mg/g; mg/g N 20181231 49967-643_c2873b9d-72ca-4d4a-b1ad-b4ca824af57e 49967-643 HUMAN OTC DRUG Kiehls Since 1851 Butterstick Lip Treatment Broad Spectrum SPF 25 Sunscreen Avobenzone, Octinoxate and Octocrylene LIPSTICK TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTINOXATE; OCTOCRYLENE 30; 60; 60 mg/g; mg/g; mg/g N 20181231 49967-644_db19d4ba-48c3-40d2-ae56-6571a06e30a7 49967-644 HUMAN OTC DRUG Garnier Ultra Lift Anti Wrinkle Firming Moisturizer Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 30 mg/mL; mg/mL; mg/mL N 20181231 49967-645_ce099258-98e0-4386-a0fa-551a04350995 49967-645 HUMAN OTC DRUG Lancome Paris Renergie Lift MultiAction Dry Avobenzone Octisalate Octocrylene CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 3.5 g/50g; g/50g; g/50g N 20181231 49967-651_ac123b6a-3001-4fd0-8f19-567c9fc2a69a 49967-651 HUMAN OTC DRUG LOreal Paris Visible Lift Line Minimizing and Tone Enhancing Makeup Broad Spectrum SPF 17 Octinoxate LIQUID TOPICAL 20030101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 60 mg/mL N 20181231 49967-658_f4aeb471-97b6-49bc-998e-5821def2fb13 49967-658 HUMAN OTC DRUG LOreal Paris Age Perfect Glow Renewal Day Moisturizer Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-659_e978c383-c177-4ee5-9c36-e4b71ff3e2bd 49967-659 HUMAN OTC DRUG LOreal Paris true match super blendable compact makeup Broad Spectrum SPF 17 Octinoxate CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 49 mg/g N 20181231 49967-661_cc85c27a-e615-4fff-bfcf-362edfa049c3 49967-661 HUMAN OTC DRUG Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 20 Sunscreen Octinoxate and Titanium Dioxide LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 75; 31 mg/mL; mg/mL N 20181231 49967-664_06034bae-3526-41a2-9af4-d063bd9259f4 49967-664 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Pigmentclar Daily Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-667_a121a70a-44b0-4cfc-b2bb-6ed8d61867f3 49967-667 HUMAN OTC DRUG Lancome Paris Absolue Precious Cells Broad Spectrum SPF 15 Sunscreen Intense Revitalizing Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-671_3f0702b0-cce5-4ae5-87e6-a653b317d0d4 49967-671 HUMAN OTC DRUG Garnier Skin Naturals Lift SPF 15 Day Ensulizole Octinoxate CREAM TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc ENSULIZOLE; OCTINOXATE .85; 3.75 mL/50mL; mL/50mL E 20171231 49967-674_c911c06d-9230-4df8-9bb7-5ae00942fabf 49967-674 HUMAN OTC DRUG Yves Saint Laurent Top Secrets CC Primer Color Correcting Primer Broad Spectrum SPF 35 Sunscreen Octinoxate and Titanium Dioxide LOTION TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc. OCTINOXATE; TITANIUM DIOXIDE 50; 63 mg/mL; mg/mL N 20181231 49967-686_18bbd72e-c426-4861-994b-205578044d18 49967-686 HUMAN OTC DRUG LOreal Paris Skin Expertise Revitalift Deep-Set Wrinkle Repair Eye Cream 24 Hour Eye Repair Duo SPF 15 Avobenzone Octisalate Octocrylene LOTION TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE .18; .3; .18 mL/6mL; mL/6mL; mL/6mL E 20171231 49967-689_f22ca315-4298-4207-8570-8737e71949d6 49967-689 HUMAN OTC DRUG LOreal Paris Revitalift Clinical Repair 10 SPF 20 Avobenzone Homosalate Octisalate Octocrylene LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.5; 5; 2.5; 3.5 mL/50mL; mL/50mL; mL/50mL; mL/50mL E 20171231 49967-699_480d73af-42ba-41a8-8dc9-ed2c1bf17808 49967-699 HUMAN OTC DRUG Garnier Skin Renew Daily Moisture Anti Sun Damage Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL N 20181231 49967-700_49b73b92-cf55-4d0d-89dd-9f67a7bce04b 49967-700 HUMAN OTC DRUG SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 30 Sunscreen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 50 mg/mL; mg/mL E 20171231 49967-701_3f6d6a9a-91fe-40bd-9864-f197cec0f17a 49967-701 HUMAN OTC DRUG CeraVe Developed with Dermatologists Psoriasis Moisturizing Salicylic Acid CREAM TOPICAL 20170830 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc SALICYLIC ACID 20 mg/g N 20181231 49967-703_bdeb7924-362e-41aa-ba65-af63c32cd076 49967-703 HUMAN OTC DRUG LOreal Paris Advanced Suncare Quick Dry Sheer Finish 50 Plus Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 49967-707_f087048f-0691-4d52-81a5-ac5c61664ac1 49967-707 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions Activated Sun Protector Sunscreen Broad Spectrum SPF 50 For Body Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.5; 22.5; 7.5; 7.5; 9 mL/150mL; mL/150mL; mL/150mL; mL/150mL; mL/150mL N 20181231 49967-709_43059da3-b4d8-4663-9a53-f02b7ce6f3ed 49967-709 HUMAN OTC DRUG Garnier Ultra Lift Deep Wrinkle Intensive Day Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 20; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-710_c0f8b8d2-4a4a-46ff-82a5-d26d83092927 49967-710 HUMAN OTC DRUG LOreal Paris Visible Lift Repair Absolute Rapid Age Reversing Makeup Broad Spectrum SPF 16 Sunscreen Titanium Dioxide CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 61 mg/g N 20181231 49967-713_99ea31b8-6707-40d5-af52-91d4660b209d 49967-713 HUMAN OTC DRUG Giorgio Armani Maestro Sunscreen Fusion Makeup SPF 15 Octinoxate LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .9 mL/30mL N 20181231 49967-714_e395aa65-0b5a-4273-acaf-e8469d8ba804 49967-714 HUMAN OTC DRUG Giorgio Armani Maestro Fusion Makeup Broad Spectrum SPF 15 Sunscreen Octinoxate LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL N 20181231 49967-715_a5f9168f-e918-400a-87cc-dd49a238cba5 49967-715 HUMAN OTC DRUG Maybelline New York Fit Me Foundation Octinoxate LIQUID TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 2.1 mL/30mL E 20171231 49967-720_7f7eac59-91bf-4efd-9ff0-ee5e22dd1a65 49967-720 HUMAN OTC DRUG Garnier SkinActive Moisture Rescue Broad Spectrum SPF 15 Sunscreen Oil Free All Skin Types Actively Hydrating Daily Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 50 mg/mL; mg/mL; mg/mL N 20181231 49967-724_cf3d4439-b9f5-4654-ae7f-a5a5fd49d383 49967-724 HUMAN OTC DRUG LOreal Paris Youth Code Broad Spectrum SPF 15 BB Octinoxate and Titanium Dioxide CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 40; 36 mg/mL; mg/mL N 20181231 49967-728_f67badd6-a37a-46fe-89c9-5a37cdb25f36 49967-728 HUMAN OTC DRUG La Roche Posay Redermic C UV Sunscreen Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 70 mg/mL; mg/mL; mg/mL N 20181231 49967-736_433deca4-92d5-4971-9d08-0a5582e072af 49967-736 HUMAN OTC DRUG Lancome Paris Skin Feels Good Broad Spectrum SPF 23 Sunscreen Hydrating Skin Tint Healthy Glow Octinoxate LIQUID TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL N 20181231 49967-754_2659d3fd-7de4-4233-ae19-62ba8969cae7 49967-754 HUMAN OTC DRUG Lancome Paris Bienfait UV 50 Plus Broad Spectrum SPF 50 Plus Water Resistant 80 Minutes Super Fluid Facial Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-760_88dca72b-20be-4c56-bd08-adbb722e3223 49967-760 HUMAN OTC DRUG Cerafill Retaliate Extra Strength For Men Minoxidil SOLUTION TOPICAL 20140428 20180430 ANDA ANDA075518 L'oreal Usa, Inc. MINOXIDIL 50 mg/mL N 20181231 49967-768_de6f81f1-7a3e-4cf7-8350-f45ad6365f82 49967-768 HUMAN OTC DRUG Lancome Paris Renergie Lift MultiAction Ultra Firming and Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-770_fd42173b-1e79-4db4-bdb5-d73d63fd0d53 49967-770 HUMAN OTC DRUG SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 Sunscreen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 50 mg/mL; mg/mL N 20181231 49967-779_d031ae94-34dc-4403-99ff-b08082b9c44b 49967-779 HUMAN OTC DRUG Garnier Skin Renew Miracle Skin Perfector BB Octinoxate and Titanium Dioxide CREAM TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 40; 21 mg/mL; mg/mL N 20181231 49967-787_819ae151-0747-4fa3-aa01-b35f49e70119 49967-787 HUMAN OTC DRUG Yves Saint Laurent Touche Eclat Le Teint Radiance Awakening Foundation Broad Spectrum SPF 22 Sunscreen Octinoxate LOTION TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 68 mg/mL N 20181231 49967-789_215b3f18-7a5f-4f70-a64d-482ad3113b4a 49967-789 HUMAN OTC DRUG Yves Saint Laurent Le Teint Encre De Peau Fusion Ink Foundation Broad Spectrum SPF 18 Sunscreen Octinoxate LOTION TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL N 20181231 49967-790_d3365441-0254-47d8-b63a-a2d71fdbe852 49967-790 HUMAN OTC DRUG Kiehls Since 1851 Facial Fuel UV Guard Broad Spectrum SPF 50 Plus Sunscreen WR80 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-795_bf13769b-fe2f-43fd-bc34-25f12bc4a391 49967-795 HUMAN OTC DRUG Redken 5th Avenue NYC Scalp Relief Dandruff Control Pyrithione Zinc SHAMPOO TOPICAL 20060817 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49967-797_8af7b757-3166-44ba-aaf8-39623acce125 49967-797 HUMAN OTC DRUG Kiehls Since 1851 Ultra Facial Moisturizer Broad Spectrum SPF 30 Sunscreen For All Skin Types Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 70; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-799_f76bd8f8-18f8-41ea-9446-6778e24a0160 49967-799 HUMAN OTC DRUG Kiehls Since 1851 Scalp Purifying Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20120604 OTC MONOGRAPH FINAL part358H L'Oreal USA Products Inc PYRITHIONE ZINC 10 mg/mL N 20181231 49967-800_4a1d6766-5e60-4a7c-9188-e74b8eebb6d1 49967-800 HUMAN OTC DRUG SkinCeuticals Clarifying Cleanser Salicylic Acid CREAM TOPICAL 20050801 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 20 mg/mL N 20181231 49967-803_412d07ba-64a2-4aea-a0e0-532c67e8ac86 49967-803 HUMAN OTC DRUG Giorgio Armani Maestro Fusion Makeup Compact Broad Spectrum SPF 29 Sunscreen Octinoxate CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 50 mg/g E 20171231 49967-810_78bc067a-7d54-4db6-8047-cf51a1f86901 49967-810 HUMAN OTC DRUG Yves Saint Laurent Youth Liberator Serum Foundation Octinoxate LOTION TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 40 mg/mL N 20181231 49967-821_9ce030ff-b60d-41c6-96f8-de2a6b4d8ac5 49967-821 HUMAN OTC DRUG Kiehls Since 1851 CrossTerrain UV Skin Protector Broad Spectrum SPF 50 Sunscreen Water Resistant 80 Minutes Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone OINTMENT TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 75; 50 mg/g; min/g; mg/g; mg/g; mg/g N 20181231 49967-837_a684f52b-1c65-4f75-8acd-6db40ac2825e 49967-837 HUMAN OTC DRUG Maybelline New York Superstay Better Skin Skin Transforming Foundation Broad Spectrum SPF 20 Sunscreen Titanium Dioxide LOTION TOPICAL 20130131 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc TITANIUM DIOXIDE 15.3 mg/mL N 20181231 49967-839_d1f9d415-0941-4e2d-ba4f-3fc131b11cb8 49967-839 HUMAN OTC DRUG Lancome Teint Idole Ultra 24H Makeup SPF 15 Sunscreen Octinoxate LOTION TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .9 mL/30mL E 20171231 49967-844_582e0e14-683c-439e-bf7a-c487b601adb0 49967-844 HUMAN OTC DRUG LOreal Paris Visible Lift Instant Age Reversing Foundation SPF 17 Octinoxate Titanium Dioxide LIQUID TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 1.375; 2.225 mL/25mL; mL/25mL E 20171231 49967-857_46f7ed04-be77-4dfb-b46c-6645e4981e99 49967-857 HUMAN OTC DRUG Lancome Paris Renergie Lift Volumetry Volumetric Lifting and Reshaping SPF 15 Normal Combination Skin Avobenzone Octisalate Octocrylene CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 3.5 g/50g; g/50g; g/50g E 20171231 49967-859_28d52669-5d96-40a2-be17-d49919e3eecf 49967-859 HUMAN OTC DRUG Lancome Paris Renergie Lift Volumetry Volumetric Lifting and Reshaping SPF 15 Normal to Dry Skin Avobenzone Octisalate Octocrylene CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 3.5 g/50g; g/50g; g/50g E 20171231 49967-860_a867b6d9-d118-4a9b-bcab-b91272f2cf3d 49967-860 HUMAN OTC DRUG Lancome Paris Flash Bronzer AntiAge Tinted Antiage SelfTanning Face Lotion SPF 15 Avobenzone Homosalate Octisalate Octocrylene LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2.5; 3.5 mL/50mL; mL/50mL; mL/50mL; mL/50mL E 20171231 49967-862_7e4e431b-7373-479f-a8fc-400ffafa5671 49967-862 HUMAN OTC DRUG LOreal Paris Skin Expertise Revitalift Complete SPF 30 Day AntiWrinkle and Firming Moisturizer Avobenzone Homosalate Octisalate Octocrylene LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.5; 2.35; 2.5; 3.5 mL/50mL; mL/50mL; mL/50mL; 1/50mL E 20171231 49967-863_1d665e84-5a8f-4a31-98c4-fb05f03f2304 49967-863 HUMAN OTC DRUG LOreal Paris true match super blendable makeup broad spectrum spf 17 Titanium Dioxide LIQUID TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 32.6 mg/mL N 20181231 49967-864_d8064f58-b0db-4712-b54a-6a1e3ea8084a 49967-864 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 60 Melt In Sunscreen Milk Face and Body Broad Spectrum SPF 60 Water Resistant 80 Minutes Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; 1/mL N 20181231 49967-867_26e5b09a-c370-4471-af87-d7de08675898 49967-867 HUMAN OTC DRUG Lancome Paris Photogenic Lumessence Light Mastering and Line Smoothing Makeup Normal to Dry Skin Broad Spectrum SPF 15 Sunscreen Octinoxate LOTION TOPICAL 20101223 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc OCTINOXATE 50 mg/mL N 20181231 49967-875_54a6aa23-2e01-4583-a129-251457a65ee1 49967-875 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions Breakout Control Acne Treatment Facial Salicylic Acid LOTION TOPICAL 20161101 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 15 mg/mL N 20181231 49967-882_00971c47-11c9-4d12-b6e6-919f956cd52a 49967-882 HUMAN OTC DRUG Kiehls Since 1851 Superbly Efficient Antiperspirant and Deodorant Aluminum chlorohydrate CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part350 L'Oreal USA Products Inc ALUMINUM CHLOROHYDRATE 128 mg/mL N 20181231 49967-883_22016df6-5775-4b9b-bf0a-cc2bc5e726aa 49967-883 HUMAN OTC DRUG Vichy Laboratoires Ideal Capital Soleil 50 Sunscreen Broad Spectrum SPF 50 Water Resistant 40 Minutes Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20150520 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-889_dabbeeff-868a-45be-96c9-88ad7526a45b 49967-889 HUMAN OTC DRUG Vichy Laboratoires Ideal Capital Soleil 60 Sunscreen Broad Spectrum SPF 60 Water Resistant 40 Minutes Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20150520 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-891_fd7088c6-9abb-4d59-8955-07fdb8fc4d8c 49967-891 HUMAN OTC DRUG Vichy Laboratoires Capital Soleil SPF 50 Ultra Light Sunscreen Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL E 20171231 49967-893_b84f61db-412f-4307-b50f-5b17b3f44a0a 49967-893 HUMAN OTC DRUG LOreal Paris Visible lift Serum Absolute Advanced Age Reversing Makeup Broad Spectrum SPF 17 Octinoxate and Titanium Dioxide LIQUID TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 10; 67 mg/mL; mg/mL N 20181231 49967-895_494d11bc-f075-4e7e-ba44-e25fc5388875 49967-895 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot Treatment Sulfur LOTION TOPICAL 20161101 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SULFUR 100 mg/mL N 20181231 49967-898_c1a2a599-2c5c-43e3-bc4c-f4cd3fe303d6 49967-898 HUMAN OTC DRUG Lancome Paris Teint Idole Fresh Wear Enduring Shine Free Makeup Broad Spectrum SPF 15 Sunscreen Octinoxate LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL N 20181231 49967-899_92fc30b7-4470-4c60-ae84-31b47a435b96 49967-899 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE 110 mg/mL N 20181231 49967-902_4b3d6edf-223b-4001-8104-55e5905ffef6 49967-902 HUMAN OTC DRUG Lancome Teint Idole Fresh Wear Enduring Shine Free Makeup SPF 15 Sunscreen Octinoxate LIQUID TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE .72 mL/24mL E 20171231 49967-906_ba351aca-84d6-44f7-8769-d7e7b392fa3d 49967-906 HUMAN OTC DRUG Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen Octisalate and Octocrylene LOTION TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTISALATE; OCTOCRYLENE 32; 60 mg/mL; mg/mL N 20181231 49967-907_6cae6c56-7c0f-4d34-a178-6f22435eb8ba 49967-907 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen Titanium dioxide and Zinc oxide LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 50 mg/mL; mg/mL N 20181231 49967-909_49b6613a-28f9-4e4c-adeb-bf882866da8c 49967-909 HUMAN OTC DRUG LOreal Go 360 Clean AntiBreakout Facial Cleanser Salicylic Acid LIQUID TOPICAL 20110101 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 20 mg/mL N 20181231 49967-913_1598c57e-be25-4ca0-8b2b-1ce9626a2e00 49967-913 HUMAN OTC DRUG LOreal Paris Revitalift Miracle Blur Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-921_6d6ac5c0-77f2-4fef-9dbe-86eb6d860897 49967-921 HUMAN OTC DRUG Kiehls Since 1851 Dermatologist Solutions SuperFluid UV Defense Broad Spectrum SPF 50 Plus Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20141215 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-928_451533ad-9638-4b17-860b-cd2165a8ceee 49967-928 HUMAN OTC DRUG Kerastase Densifique Minoxidil SOLUTION TOPICAL 20150223 20180331 ANDA ANDA074588 L'oreal Usa, Inc. MINOXIDIL 2 g/100mL N 20181231 49967-930_817e4951-de31-483e-8b6e-4dbfe18b6fbf 49967-930 HUMAN OTC DRUG Giorgio Armani Maestro Summer Broad Spectrum SPF 15 Sunscreen Octinoxate LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL N 20181231 49967-933_1926e668-7cdb-407c-8bfb-b6b405f7b9e1 49967-933 HUMAN OTC DRUG SoftSheenCarson Magic Bump Rescue Spot Treatment Salicylic Acid LOTION TOPICAL 20131101 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 20 mg/mL E 20171231 49967-934_eb34adac-c23e-4d93-8d85-0f37df3334dc 49967-934 HUMAN OTC DRUG LOreal Paris Age Perfect Cell Renewal Day Moisturizer Broad Spectrum SPF 15 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 50 mg/g; mg/g; mg/g; mg/g N 20181231 49967-937_ff66529f-eabb-43eb-9094-e3012ec62dc7 49967-937 HUMAN OTC DRUG Guy Laroche Paris Drakkar Essence Antiperspirant Deodorant Aluminum zirconium tetrachlorohydrex gly STICK TOPICAL 20150319 OTC MONOGRAPH FINAL part350 L'Oreal USA Products Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 160 mg/g N 20181231 49967-939_8ccb3893-830a-4aca-9065-b6e87efa3c16 49967-939 HUMAN OTC DRUG Garnier SkinActive Moisture Bomb Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 22; 80; 24; 45; 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-941_a18da5a8-7fd3-4ce4-b535-078037df3a52 49967-941 HUMAN OTC DRUG Kiehls Since 1851 Ultra Facial Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene CREAM TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 L’Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-944_c4e29d44-4661-4d88-925c-9498371fcb32 49967-944 HUMAN OTC DRUG LOreal Paris Men Expert Vita Lift Daily Moisturizer Sunscreen Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20131219 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 20; 50; 55 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-952_b6f660cb-7395-4ac7-a087-35dbb4d82512 49967-952 HUMAN OTC DRUG Lancome Paris Absolue Premium Bx Replenishing and Rejuvenating Day Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 20; 50; 80 mg/g; mg/g; mg/g N 20181231 49967-956_2bc06bef-293b-4ca6-b15b-50ff26790c1f 49967-956 HUMAN OTC DRUG Lancome Paris Teint Idole Ultra 24H Makeup Broad Spectrum SPF 15 Sunscreen Octinoxate LIQUID TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 30 mg/mL N 20191231 49967-957_3cdec159-ac84-451d-b371-7c6b0137c43a 49967-957 HUMAN OTC DRUG Maybelline Dream Pure BB Beauty Balm Salicylic Acid LOTION TOPICAL 20140601 OTC MONOGRAPH FINAL part333D L'Oreal USA Products Inc SALICYLIC ACID 20 mg/mL N 20181231 49967-969_a633efc4-c6c4-46df-8587-fb55049eb3c9 49967-969 HUMAN OTC DRUG Maybelline New York Fit Me Foundation Dewy Plus Smooth SPF 18 Sunscreen Octinoxate LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 70 mg/mL N 20181231 49967-971_c3cebf32-ea19-4a04-aa17-9f009b7cc5f8 49967-971 HUMAN OTC DRUG Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 30 Sunscreen Water Resistant 80 MInutes Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20150215 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 22.4; 80; 24; 44.8; 28.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-972_9cb35f7c-21b1-4b55-bebc-d2fdace7f52b 49967-972 HUMAN OTC DRUG Garnier Skin Renew Miracle Skin Perfector Combination to Oily Skin BB Broad Spectrum SPF 20 Sunscreen Octinoxate and Titanium dioxide CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE; TITANIUM DIOXIDE 30; 47 mg/mL; mg/mL N 20181231 49967-980_fae075a9-15f8-4f3b-beb8-f8e95b21aa1e 49967-980 HUMAN OTC DRUG LOreal Paris Visible Lift Blur Foundation Broad Spectrum SPF 18 Sunscreen Octinoxate LOTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc OCTINOXATE 75 mg/mL N 20181231 49967-981_5052e77f-56b7-4867-a558-48c5fe2983af 49967-981 HUMAN OTC DRUG LOreal Paris Ideal Moisture Normal Skin Broad Spectrum SPF 25 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-982_3eeb1eb4-e496-4f3c-9493-3f1dfd6001bf 49967-982 HUMAN OTC DRUG LOreal Paris Ideal Moisture Dry Skin Broad Spectrum SPF 25 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 20; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-983_92c311d4-84d7-45e0-a872-028d2efdbe65 49967-983 HUMAN OTC DRUG LOreal Paris Ideal Moisture Sensitive Skin Broad Spectrum SPF 25 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 20; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-984_fce64240-4337-499d-8972-9b7b707d71e9 49967-984 HUMAN OTC DRUG LOreal Paris Ideal Moisture Even Skin Tone Moisturizer Broad Spectrum SPF 25 Sunscreen Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-994_943b5f7c-1d95-4cc7-aea7-e33f53dde92d 49967-994 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes Avobenzone, Homosalate, Octisalate and Octocrylene LOTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 150; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 49967-999_e96957f6-36ef-46b8-bbbf-d1d364727872 49967-999 HUMAN OTC DRUG Vichy Laboratoires Capital Soleil 30 Sunscreen Luxurious Protective Avobenzone Homosalate Octisalate Octocrylene Oxybenzone OIL TOPICAL 20120307 OTC MONOGRAPH NOT FINAL part352 L'Oreal USA Products Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 5.31; 26.55; 8.85; 12.39; 10.62 mL/177mL; mL/177mL; mL/177mL; mL/177mL; mL/177mL N 20181231 49969-001_9a4ddddf-0ca7-4988-919b-974958cb7811 49969-001 HUMAN OTC DRUG Jun Wai Lung Medicine Pain relieving Camphor Menthol Methyl Salicylate OIL TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 Wah Sing Pharmaceutical Limited CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 15; 33 g/100mL; g/100mL; g/100mL E 20171231 49969-002_616dd1ab-b262-493a-9cc9-76b04e70e3e7 49969-002 HUMAN OTC DRUG Zihuadick Pain relieving Camphor Menthol Methyl Salicylate LIQUID TOPICAL 20131230 OTC MONOGRAPH NOT FINAL part348 Wah Sing Pharmaceutical Limited CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3; 10; 10 g/100mL; g/100mL; g/100mL E 20171231 49972-001_09fa9785-b76d-4fc6-8bb3-883d97d8eaca 49972-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC OXYGEN 990 mL/L E 20171231 49972-002_e13e1878-48f5-4f9a-bc2a-77fc21dc6eaa 49972-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC NITROGEN 990 mL/L E 20171231 49972-003_039a0d72-7c14-4a26-b1de-e7015caa19af 49972-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 49972-004_845551da-0662-4741-bb99-2b834f8c97f3 49972-004 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC NITROUS OXIDE 990 mL/L E 20171231 49972-006_32884d25-191f-4a8c-bef7-5864b4a15fff 49972-006 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20020501 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC AIR 1000 mL/L E 20171231 49972-008_6acbb947-9026-4329-aad2-0b4adf2375c2 49972-008 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mix Carbon Dioxide Oxygen Mix GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution Southest LLC CARBON DIOXIDE; OXYGEN 300; 700 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 49972-009_1a00ab3c-4e4f-4c78-876c-9a973789b7d7 49972-009 HUMAN PRESCRIPTION DRUG Helium Oxygen mixture Helium Oxygen mixture GAS RESPIRATORY (INHALATION) 20070801 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC HELIUM; OXYGEN 800; 200 mL/L; mL/L E 20171231 49972-010_8bb5643c-ffd6-462e-aa8f-821b54937b4a 49972-010 HUMAN PRESCRIPTION DRUG Helium Oxygen Nitrogen mixture Helium Oxygen Nitrogen mixture GAS RESPIRATORY (INHALATION) 20051001 UNAPPROVED MEDICAL GAS Praxair Distribution Southeast LLC HELIUM; OXYGEN; NITROGEN 200; 500; 300 mL/L; mL/L; mL/L E 20171231 49973-011_52100db9-e4cb-46ed-b669-75877ada87ec 49973-011 HUMAN OTC DRUG Azo Urinary Tract Defense Antibacterial Protection Methenamine, Sodium salicylate TABLET ORAL 20151106 UNAPPROVED DRUG OTHER i-Health, Inc. METHENAMINE; SODIUM SALICYLATE 162; 162.5 mg/1; mg/1 N 20181231 49973-244_2306a17a-efc3-4dfb-9112-9125b07fc305 49973-244 HUMAN OTC DRUG AZO Urinary Pain Relief TABLET ORAL 20120518 UNAPPROVED DRUG OTHER i-Health, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20191231 49973-245_57a0fc53-42db-42e2-9982-16ada0fd9e39 49973-245 HUMAN OTC DRUG AZO Urinary Pain Relief TABLET ORAL 20140304 UNAPPROVED DRUG OTHER i-Health, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 49973-246_a8503d45-f0ff-4b59-90c0-388b216c6725 49973-246 HUMAN OTC DRUG AZO Urinary Pain Relief Maximum Strength Phenazopyridine Hydrochloride TABLET ORAL 20150209 UNAPPROVED DRUG OTHER i-Health, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 49973-246_c514fe60-e0d0-44e7-b7dc-3794186227f1 49973-246 HUMAN OTC DRUG AZO Urinary Pain Relief Maximum Strength Phenazopyridine Hydrochloride TABLET ORAL 20150209 UNAPPROVED DRUG OTHER i-Health, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 49973-301_7fe8bb8d-8752-433b-8b66-5da5bb2f07eb 49973-301 HUMAN OTC DRUG AZO Urinary Pain Relief TABLET ORAL 20120524 UNAPPROVED DRUG OTHER i-Health, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 49973-606_7597b3c7-2fa7-4a91-b90f-32a64f3434aa 49973-606 HUMAN OTC DRUG AZO Yeast Eupatorium Perfoliatum Flowering Top and Viscum Album Leaf TABLET ORAL 20120522 UNAPPROVED HOMEOPATHIC i-Health, Inc. EUPATORIUM PERFOLIATUM FLOWERING TOP; VISCUM ALBUM LEAF 5; 5 [hp_X]/1; [hp_X]/1 N 20181231 49973-667_66137af6-89d6-435f-bf43-5a1e19018ed6 49973-667 HUMAN OTC DRUG AZO Yeast Plus Candida Albicans, Wood Creosote, Sodium Chloride, and Sulfur TABLET ORAL 20141001 UNAPPROVED HOMEOPATHIC i-Health, Inc. CANDIDA ALBICANS; WOOD CREOSOTE; SODIUM CHLORIDE; SULFUR 30; 30; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 49973-760_a8aa0528-6988-45f0-8fff-8b0184a112f5 49973-760 HUMAN PRESCRIPTION DRUG AZO Urinary Tract Health Phenazopyridine Hydrochloride TABLET ORAL 20140228 UNAPPROVED DRUG OTHER i-Health, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 49973-761_57355928-2301-4f98-b6d9-5c8a541d0a70 49973-761 HUMAN OTC DRUG AZO Urinary Pain Relief Phenazopyridine Hydrochloride TABLET ORAL 20141101 UNAPPROVED DRUG OTHER i-Health, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 49980-001_263af858-1edb-47ab-8ef5-928a86695024 49980-001 HUMAN OTC DRUG Zhenweilong Huoluo You External Analgesic Camphor Menthol Methyl Salicylate OIL TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 Hong Kong Zihua Pharmaceutical Ltd. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 10; 15; 30 g/100mL; g/100mL; g/100mL E 20171231 49980-003_6f8edaf3-ed18-49f4-93fb-e39e191a85cf 49980-003 HUMAN OTC DRUG ZIHUA EMBROCATION Cooling Pain Relief Camphor Menthol Methyl Salicylate OIL TOPICAL 20140415 OTC MONOGRAPH NOT FINAL part348 Hong Kong Zihua Pharmaceutical Ltd. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 11; 15; 15 g/100mL; g/100mL; g/100mL E 20171231 49981-001_64bad65e-2db3-49e3-8a5f-bbae6424f883 49981-001 HUMAN OTC DRUG Jasmine Rose Hand Wash Nettoyant Pour Les Mains None Hand Wash LIQUID TOPICAL 20091112 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-002_5a3df9d3-ac22-487f-a888-811ba2b0979f 49981-002 HUMAN OTC DRUG Hand Wash Nettoyant Pour Les Mains Orange Pekoe None Hand Wash LIQUID TOPICAL 20091115 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-003_7abab773-55b2-4d33-b499-d841b4ac0f61 49981-003 HUMAN OTC DRUG Hand Wash Nettoyant Pour Les Mains Vallina Tuberose None Hand Wash LIQUID TOPICAL 20091115 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-004_d7d37c8a-5e38-455b-9626-c47336490f1e 49981-004 HUMAN OTC DRUG Hand Wash Nettoyant Pour Les Mains Plum Grapefruit None Hand Wash LIQUID TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-005_66c815bc-afa2-4db8-891e-669857c89ebc 49981-005 HUMAN OTC DRUG Hand Wash Nettoyant Pour Les Mains Citrus Cilantro None Hand Wash LIQUID TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-007_646fe108-8ec7-4ac5-bfd2-bda0a442fb88 49981-007 HUMAN OTC DRUG Pier 1 Imports Coconut Breeze Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-008_6cbebeea-b8ae-4f19-b015-b174fbd2b5a0 49981-008 HUMAN OTC DRUG Pier 1 Imports Ocean Water Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-009_3aa02027-ef00-438e-8d4d-7bd296d42143 49981-009 HUMAN OTC DRUG Pier 1 Imports Lily Flower Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-010_3647eb43-25cb-4baa-9423-68e43ce254ea 49981-010 HUMAN OTC DRUG Pier 1 Imports Sweet Cherry Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-011_9c0b7379-8276-4b95-84e2-c3c777faf4cd 49981-011 HUMAN OTC DRUG Pier 1 Imports Warm Vanilla Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-012_8b3bfcbd-ebc1-4100-823f-14ee5ce37a44 49981-012 HUMAN OTC DRUG Pier 1 Imports Cool Watermelon Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-013_3beda4f1-7b13-49a5-8900-422ccccafca3 49981-013 HUMAN OTC DRUG Pier 1 Imports Sweet Orange Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-014_ea8c9409-72d6-4d5d-a583-39d0ba5543d2 49981-014 HUMAN OTC DRUG Pier 1 Imports Granny Smith Apple Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-016_f467a19d-71b3-4f7f-ac67-d6c96c0813f7 49981-016 HUMAN OTC DRUG Pier 1 Imports Citrus and Sunflowers Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-017_87358109-1e2b-4ab7-acb6-0d5ccde111f7 49981-017 HUMAN OTC DRUG Pier 1 Imports Sweet Grape Anti-bacterial Hand Wash N/A Anti-bacterial Hand Wash LIQUID TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd TRICLOSAN .115 g/100g E 20171231 49981-018_f3f49066-7e24-4243-b202-36f938612d42 49981-018 HUMAN OTC DRUG Body Blends Apple Attraction Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd ALCOHOL 62 g/100g E 20171231 49981-019_4075c19c-9704-40fd-ad18-cb26fddff5be 49981-019 HUMAN OTC DRUG Body Blends Citrus Awakening Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd ALCOHOL 62 g/100g E 20171231 49981-020_8afd6ec7-13e7-4f1c-92a1-57457d1f9c42 49981-020 HUMAN OTC DRUG Body Blends Coconut Lime Escape Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd ALCOHOL 62 g/100g E 20171231 49981-021_fc92e622-c701-4b34-983e-d182520a630a 49981-021 HUMAN OTC DRUG Body Blends Vanilla Sugar Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333 Xiamen Anna Global Co., Ltd ALCOHOL 62 g/100g E 20171231 49981-022_c59fa27c-b9f1-4538-ae16-baa196461303 49981-022 HUMAN OTC DRUG Friuts and Flowers Clean Cotton Waterless Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100810 OTC MONOGRAPH NOT FINAL part333E Xiamen Anna Global Co., Ltd ALCOHOL 62 g/100g E 20171231 49981-023_230c20f0-9a63-4e00-9ea3-1cf45266bfaa 49981-023 HUMAN OTC DRUG Friuts and Flowers Grapefruit Waterless Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100810 OTC MONOGRAPH NOT FINAL part333E Xiamen Anna Global Co., Ltd ALCOHOL 62 g/100g E 20171231 49989-515_5a9e1728-8a4b-4608-96f4-7115405927a8 49989-515 HUMAN OTC DRUG JANITECH JAN-HS-40 INSTANT HAND SANITIZER alcohol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 CHEM-SALES INC. ALCOHOL 600 mL/1000mL E 20171231 49991-001_ce25e2f5-f431-4c82-acd9-5984c12f2efb 49991-001 HUMAN OTC DRUG Rich Girl Hand Avobenzone, Octinoxate, and Octisalate CREAM TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 Lippmann Enterprises, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 2; 7.5; 5 g/100g; g/100g; g/100g N 20181231 49993-860_a6232b52-e181-42a1-9140-b096cf7dd43f 49993-860 HUMAN OTC DRUG Glo Scinece Antioxidant Fluoride PASTE, DENTIFRICE DENTAL 20120601 OTC MONOGRAPH FINAL part355 GLO Science Inc SODIUM MONOFLUOROPHOSPHATE .84 g/100g N 20181231 49993-861_cc10ab81-f079-4582-aa58-26259b026d41 49993-861 HUMAN OTC DRUG Glo Science Antioxidant Fluoride PASTE, DENTIFRICE DENTAL 20120601 OTC MONOGRAPH FINAL part355 GLO Science Inc SODIUM MONOFLUOROPHOSPHATE .84 g/100g N 20181231 49997-356_b5858372-b8af-4805-b3ac-4e2c5d2152e4 49997-356 HUMAN OTC DRUG RhinoBlaster Nasal Spray SPRAY NASAL 20100203 UNAPPROVED HOMEOPATHIC JD888 LLC CHILI PEPPER 6 [hp_X]/30mL E 20171231 49998-332_462cee25-b508-4d40-9b67-acd87bb3a3d1 49998-332 HUMAN OTC DRUG Trival Homeopathic Alopecia Areata Treatment TINCTURE TOPICAL 20091222 UNAPPROVED HOMEOPATHIC TE-Point Doo URTICA URENS; OLEA EUROPAEA FLOWER; ST. JOHN'S WORT; FRAGARIA VESCA FRUIT; GARLIC; FAGUS SYLVATICA NUT 1; 1; 2; 1; 1; 1 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 49999-002_09855f5a-3359-4cc6-a60d-11be7c3b93a8 49999-002 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20070413 ANDA ANDA062936 Lake Erie Medical DBA Quality Care Products LLC PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 49999-003_da8b8453-3e45-4ab6-9a89-7c82d0e95f8d 49999-003 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 49999-006_810fae04-8338-43ab-afdf-ba3bfa7160bd 49999-006 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20111121 ANDA ANDA078558 Lake Erie Medical DBA Quality Care Products LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-011_f726e8ad-0ae8-46c6-8a63-964fcefca44c 49999-011 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20110201 ANDA ANDA063083 Lake Erie Medical DBA Quality Care Products LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 49999-015_48f55c42-0d49-4bb4-97fc-afc3a0d9bc4e 49999-015 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20111215 ANDA ANDA065291 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 49999-016_c7261192-4825-4524-a801-069ebd34d2a0 49999-016 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 49999-020_6ef25d95-4d05-4899-a33a-7dda5e54415c 49999-020 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20111207 ANDA ANDA065095 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 49999-020_ba1c1248-12c7-446d-a0af-cebd584bca43 49999-020 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20111207 ANDA ANDA065095 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 49999-021_eaf9b4bf-aa93-417b-8d6e-d6e2e6fdde0a 49999-021 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20060207 ANDA ANDA065311 Lake Erie Medical DBA Quality Care Products LLC CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 49999-022_1bc87bc7-23f7-419d-829e-b7408d9d9871 49999-022 HUMAN PRESCRIPTION DRUG ULTRAM tramadol hydrochloride TABLET, COATED ORAL 20120320 NDA NDA020281 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 49999-024_f924573c-9d67-4836-85c7-eb11f7ca2fe2 49999-024 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20111121 ANDA ANDA040804 Lake Erie Medical DBA Quality Care Products LLC HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 49999-028_ac6cb2cc-7906-49bf-9a7c-41c680bce592 49999-028 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20100811 ANDA ANDA040256 Lake Erie medical DBA Quality Care Products LLC PREDNISONE 10 mg/1 N 20181231 49999-029_e18eab59-9856-4723-8b1f-876dcbadb111 49999-029 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120123 ANDA ANDA087128 Lake Erie Medical DBA Quality Care Products LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 49999-030_a0c7cfb2-b022-4376-a330-bec0ab3d9248 49999-030 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20111128 NDA NDA018569 Lake Erie Medical DBA Quality Care Products LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 49999-032_cdfe44a1-4b6a-4813-b4e5-f80e2f841913 49999-032 HUMAN PRESCRIPTION DRUG Alprazolam ALPRAZOLAM TABLET ORAL 20100401 ANDA ANDA074112 Lake Erie Medical DBA Quality Care Products LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49999-034_e0e8404e-3d19-4373-96f3-66c900970b91 49999-034 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20100701 ANDA ANDA078218 Lake Erie Medical DBA Quality Care Product LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 49999-035_8946b1bf-d18d-489f-838e-775bee031454 49999-035 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20111128 ANDA ANDA091176 Lake Erie Medical DBA Quality Care Products LLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 49999-037_c6482978-0820-48b8-b3e9-ac5970ce26a9 49999-037 HUMAN PRESCRIPTION DRUG Ambien zolpidem tartrate TABLET, FILM COATED ORAL 20090630 NDA NDA019908 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 49999-038_cd46a6ca-e30f-49a6-a411-12d083036c80 49999-038 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20111219 ANDA ANDA074903 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 49999-039_189cc961-c8a8-4706-8768-e1db58056c92 49999-039 HUMAN PRESCRIPTION DRUG Alprazolam ALPRAZOLAM TABLET ORAL 20100401 ANDA ANDA074112 Lake Erie Medical DBA Quality Care Products LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49999-042_4d652dd7-25d5-47f1-a403-d7f6f3ce0744 49999-042 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20101019 ANDA ANDA076112 Lake Erie Medical DBA Quality Care Products LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-043_0175b20d-1379-46ba-85b1-af7d3da80325 49999-043 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20101006 ANDA ANDA075180 Lake Erie Medical DBA Quality Care Products LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 49999-044_41348867-7110-40f8-be0a-da7becda2669 49999-044 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110412 ANDA ANDA089859 Lake Erie Medical DBA Quality Care Products LLC CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 49999-046_e33e1451-7da8-4ed4-b0b8-87e98e4622ea 49999-046 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 20110207 ANDA ANDA040284 Lake Erie Medical DBA Quality Care Products LLC ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 49999-048_9f10c663-3b60-4a8f-9a10-988d5fd9f1a0 49999-048 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20111116 ANDA ANDA085159 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 49999-049_b17920e0-b17b-4edf-9638-da0f78182831 49999-049 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20111104 ANDA ANDA078250 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-050_f3afcca3-2a9f-4369-8a48-e5e8703ae30a 49999-050 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Lake Erie Medical DBA Quality Care Products LLC PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 49999-051_9f511e95-b671-47d4-a086-db59060fb679 49999-051 HUMAN PRESCRIPTION DRUG Vicodin Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 19830107 ANDA ANDA088058 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 49999-055_c56f1c4e-d9db-4afa-b2fc-1bc5f17157f9 49999-055 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 20110601 ANDA ANDA074224 Lake Erie Medical DBA Quality Care Products LLC TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49999-057_6961f280-d0c6-4f2f-ad43-8ab638831c7e 49999-057 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Lake Erie Medical DBA Quality Care Products LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 49999-058_35ca46f3-497b-41be-8154-a3bac37cd4a6 49999-058 HUMAN PRESCRIPTION DRUG NAPROXEN naproxen sodium TABLET, FILM COATED ORAL 19960514 ANDA ANDA074480 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-059_5f4dd2ca-caba-492c-ab75-43136ee60d57 49999-059 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 Lake Erie Medical DBA Quality Care Products LLC DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49999-060_e2864205-6e0d-4aa2-9703-f9207981a2ea 49999-060 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET ORAL 20110914 ANDA ANDA040419 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 49999-063_0a1cb449-1ca0-4dd9-a630-1e6624ae20f3 49999-063 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA085966 Lake Erie Medical DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 49999-064_b8134afe-556f-4975-b5b8-8c2fd8eb120b 49999-064 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20111111 ANDA ANDA040245 Lake Erie Medical DBA Quality Care Products LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 49999-066_287bedf2-68dc-48df-adf2-0e348415f6ae 49999-066 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide triamterene and hydrochlorothiazide CAPSULE ORAL 20110504 ANDA ANDA074701 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 49999-068_1922679a-99fc-452a-ab2c-72828523edcf 49999-068 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET ORAL 19970109 ANDA ANDA074661 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN SODIUM 220 mg/1 N 20181231 49999-071_01e0cf61-39c8-448b-a0dd-d81578fcec6a 49999-071 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20120216 OTC MONOGRAPH NOT FINAL part343 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC IBUPROFEN 200 mg/1 N 20181231 49999-074_fb7fb7bc-b028-4889-9e2d-54e7a346d123 49999-074 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19940126 ANDA ANDA074131 Lake Erie Medical DBA Quality Care Products LLC PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-075_1c7e621d-974c-4b0d-929a-02efd455408a 49999-075 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090917 ANDA ANDA078906 Lake Erie Medical DBA Quality Care Products LLC VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 49999-078_b440e65b-3007-4d7f-b478-0852404c8a1e 49999-078 HUMAN OTC DRUG Guaifenesin Extended Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20120328 ANDA ANDA078912 Lake Erie Medical DBA Quality Care Products LLC GUAIFENESIN 600 mg/1 N 20181231 49999-081_7945bc72-adc1-41f2-bdfe-919838a232f6 49999-081 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20111118 ANDA ANDA085223 Lake Erie Medical DBA Quality Care Products LLC DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 49999-083_9f73eaf3-3241-45f7-802c-f186a89a413c 49999-083 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20120312 ANDA ANDA040114 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 49999-090_1e7c2c4c-fe7a-400b-8ae2-218463d68d47 49999-090 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20101124 ANDA ANDA083426 Lake Erie Medical DBA Quality Care Products LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 49999-090_427320ff-8aee-4d81-a968-3d9b82686a41 49999-090 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20101028 ANDA ANDA083426 Lake Erie Medical DBA Quality Care Products LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 49999-091_f2e2f2be-b9fb-49a4-9f88-a14316d8116d 49999-091 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20111205 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 49999-094_130a0a1e-a6a6-416a-91a0-838ca83df486 49999-094 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA071851 Lake Erie Medical DBA Quality Care Products LLC TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 49999-095_e41ae0ce-bd73-4964-a17f-d9bf5d909f01 49999-095 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20120316 NDA NDA070033 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 49999-097_810fae04-8338-43ab-afdf-ba3bfa7160bd 49999-097 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20111121 ANDA ANDA078558 Lake Erie Medical DBA Quality Care Products LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-099_e9a44ccf-5780-45cc-b32e-9639b354bd7d 49999-099 HUMAN OTC DRUG ACETAMINOPHEN PAIN RELIEF Acetaminophen TABLET ORAL 20120202 OTC MONOGRAPH FINAL part343 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ACETAMINOPHEN 500 mg/1 E 20171231 49999-100_a03aff24-52dc-4065-b7b1-f686cd2e8101 49999-100 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20110420 ANDA ANDA070756 Lake Erie Medical DBA Quality Care Products LLC INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-102_ccf28938-de23-4a68-b1a0-64aa71ee0ea4 49999-102 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20100826 ANDA ANDA075280 Lake Erie Medical DBA Quality Care Products LLC NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 49999-103_c41c45d4-30ce-49bf-b0e4-2d4aae89181f 49999-103 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20101116 ANDA ANDA078671 Lake Erie Medical DBA Quality Care Products LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-104_38838132-630e-411a-ac8c-e7c108cd12d6 49999-104 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100524 ANDA ANDA077877 Lake Erie Medical DBA Quality Care Products LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49999-106_c99c86f1-a491-43e5-b19f-ee15a2464659 49999-106 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110127 ANDA ANDA077095 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 49999-107_784d4a19-6056-4fb3-b306-00f5363e2ba8 49999-107 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20110531 ANDA ANDA074223 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 49999-108_4eda2774-ce9d-44cc-9a89-e200c89efab4 49999-108 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 49999-109_27dc071c-0b39-475d-8281-a1d498632e6e 49999-109 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20120321 NDA NDA004782 Lake Erie Medical DBA Quality Care Products LLC ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 49999-113_3d774b4a-3054-46c9-a86d-58094a6a8dec 49999-113 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20110223 ANDA ANDA074388 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 49999-115_46e2ef91-04a8-46ac-8773-f3c9486e25c9 49999-115 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 20120223 ANDA ANDA086162 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII E 20171231 49999-116_9b6838ca-4b1c-4615-b9de-d1f1d3234128 49999-116 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 49999-118_1786e75f-e280-4a1f-8f93-3d0d1e9d303f 49999-118 HUMAN PRESCRIPTION DRUG ULTRACET tramadol hydrochloride and acetaminophen TABLET ORAL 20120320 NDA NDA021123 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 49999-120_d47b3cbf-d3bf-4aae-87a4-14da55ed6476 49999-120 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20120319 ANDA ANDA062286 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 49999-122_9deefd7a-5305-41c8-ab1d-b23836571440 49999-122 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110131 ANDA ANDA072927 Lake Erie Medical DBA Quality Care Products LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49999-126_6862e000-ee1a-4617-9e6b-7178b2d6e40d 49999-126 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20120416 ANDA ANDA062676 Lake Erie Medical DBA Quality Care Products LLC DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 49999-127_eabc45de-a4e0-451f-90d6-16cbf521d87b 49999-127 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20100519 ANDA ANDA070317 Lake Erie Medical DBA Quality Care Products LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 49999-128_6880c6d1-48b3-45a0-9093-417cb24f7dde 49999-128 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20100819 ANDA ANDA075049 Lake Erie Medical DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 49999-130_fbb8b618-b374-4799-80f2-e57df5b0618f 49999-130 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20101117 ANDA ANDA074761 Lake Erie Medical DBA Quality Care Products LLC KETOROLAC TROMETHAMINE 10 mg/1 E 20171231 49999-131_8b913973-d543-4e12-9f87-e3a8a48cab51 49999-131 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20110421 OTC MONOGRAPH NOT FINAL part343 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN 325 mg/1 N 20181231 49999-133_878fa968-f8d1-482c-bff8-206032c3378f 49999-133 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20120323 OTC MONOGRAPH FINAL part349 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC POLYVINYL ALCOHOL 14 mg/mL E 20171231 49999-136_fbb8ef16-82eb-47e3-8ddb-c938c2c05382 49999-136 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20100118 ANDA ANDA062447 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 49999-138_b0a345f4-009c-4ca6-8267-e074633559f1 49999-138 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20120312 ANDA ANDA064048 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 49999-139_74947ad5-fc98-4d0e-b3a4-3b268c1e6132 49999-139 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19760430 ANDA ANDA080693 Lake Erie Medical DBA Quality Care Products LLC HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49999-140_ceb9d58b-727e-445f-83e8-69351703905d 49999-140 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 49999-141_963565fc-b682-48d2-98a6-7d2ebe02786f 49999-141 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone neomycin sulfate, polymyxin b sulfate and dexamethasone SUSPENSION OPHTHALMIC 19960221 ANDA ANDA062341 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49999-142_f82fe29a-dcd5-4f31-8f96-7e898cbb19e1 49999-142 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20120319 OTC MONOGRAPH FINAL part333B Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BACITRACIN 500 [USP'U]/g N 20181231 49999-143_3028f759-2298-4f22-a3b5-7b54d5e8430e 49999-143 HUMAN PRESCRIPTION DRUG SILVADENE silver sulfadiazine CREAM TOPICAL 19731126 NDA NDA017381 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 49999-144_fdbfa5ca-e859-489f-b500-5b87944ba67b 49999-144 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 19941228 ANDA ANDA040066 Lake Erie Medical DBA Quality Care Products LLC SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 49999-148_a4e51ef9-ebaa-49e2-af70-c436cd540fb2 49999-148 HUMAN PRESCRIPTION DRUG Tobramycin tobramycin SOLUTION OPHTHALMIC 19940525 ANDA ANDA063176 Lake Erie Medical DBA Quaity Care Products LLC TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 49999-150_2552e5b6-aaaf-438a-90e6-55db6882f5cd 49999-150 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20120320 ANDA ANDA086414 Lake Erie Medical DBA Quality Care Products LLC TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49999-151_403222f5-78a8-4dc7-b2ae-004829e2cd77 49999-151 HUMAN PRESCRIPTION DRUG Butalbital Acetaminophen and Caffeine Butalbital Acetaminophen and Caffeine TABLET ORAL 20101011 ANDA ANDA088616 Lake Erie Medical DBA Quality Care Products LLC BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 49999-151_97b7ecd9-5917-4abd-9d35-70de39aa7135 49999-151 HUMAN PRESCRIPTION DRUG Butalbital Acetaminophen and Caffeine Butalbital Acetaminophen and Caffeine TABLET ORAL 20101011 ANDA ANDA088616 Lake Erie Medical DBA Quality Care Products LLC BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 49999-152_4977b1d6-57d7-4630-a62c-66c0a10c3da3 49999-152 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20120321 ANDA ANDA040650 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV N 20181231 49999-153_ccfdb5dc-27b2-4f1f-aaee-16190cb04a92 49999-153 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20120209 NDA NDA011153 Lake Erie Medical DBA Quality Care Products LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49999-154_c953233a-30cd-4801-9d64-9704897fbe1f 49999-154 HUMAN OTC DRUG triple antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20110307 OTC MONOGRAPH FINAL part333B Lake Erie Medical DBA Quality Care Products LLC BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g E 20171231 49999-156_09be09a3-b215-4e27-96c1-4a2fa95d78b0 49999-156 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20111214 ANDA ANDA071524 Lake Erie Medical DBA Quality Care Products LLC TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 49999-158_e31c18ee-9fd8-40f9-871a-033f22369ee5 49999-158 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 19900129 NDA NDA019949 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 49999-159_a0e3b94b-4eac-40ab-9895-e0cf62a866e1 49999-159 HUMAN PRESCRIPTION DRUG Gentak Gentamicin Sulfate OINTMENT OPHTHALMIC 20120327 ANDA ANDA064093 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 49999-162_a239a410-be74-43f6-836b-a4e93bf06edb 49999-162 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20120206 ANDA ANDA089414 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49999-167_ee988e8e-d3da-49c1-a8ca-31f1b102dc89 49999-167 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20120328 ANDA ANDA084878 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49999-168_387f4ae6-d12a-48a0-b87c-52d7f10925e4 49999-168 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065387 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 49999-170_747fe9d8-57b0-4476-b7e2-39ec69201d53 49999-170 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20100804 ANDA ANDA090219 Lake Erie Medical DBA Quality Care Products LLC CLOTRIMAZOLE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 49999-172_89b8b3f8-ae11-4a39-ad11-91aa0fe3f2e3 49999-172 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 NDA NDA019117 Lake Erie Medical DBA Quality Care Products LLC FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49999-178_e38eb140-86b6-464c-b9e0-2229afbccd2f 49999-178 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073026 Lake Erie Medical DBA Quality Care Products LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49999-180_aeae1aff-2a5b-4baf-8589-d53a1723d716 49999-180 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Lake Erie Medical DBA Quality Care Products LLC DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 49999-181_d6f680f0-4fcd-4997-afad-f2a8520093b9 49999-181 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Lake Erie Medical DBA Quality Care Products LLC DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 49999-182_06ca94ec-b699-429d-81a3-fb3ac82a62a6 49999-182 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20120327 ANDA ANDA077321 Lake Erie Medical Quality Care Products LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 49999-183_7d814126-0fb8-41c9-a0e3-f7471c2f1f4e 49999-183 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20110719 ANDA ANDA075994 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 49999-184_0ce79c31-9d4e-4cd9-b641-ad698731e67b 49999-184 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 Lake Erie Medical DBA Quality Care Products LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] E 20171231 49999-185_1f879e75-4324-497e-920c-da822c06bcdb 49999-185 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 20120322 ANDA ANDA018578 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 49999-190_e6d803d1-1b9c-4b15-86a8-60b444a35df5 49999-190 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20120305 ANDA ANDA070791 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 49999-205_4d43f252-ba19-48d8-8efa-4168d179ba1e 49999-205 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20111031 ANDA ANDA085969 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 49999-206_317e2d79-bbe2-4bc7-8244-d4257c4bcc46 49999-206 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20001020 ANDA ANDA075536 Lake Erie Medical DBA Quality Care Products LLC DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 49999-207_c2cf5a3c-78a5-4d08-8536-ec17f60efc84 49999-207 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 Lake Erie Medical DBA Quality Care Products LLC DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 49999-210_04e4ce0c-58ae-4495-b4d5-1a8ee97453b6 49999-210 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20120403 ANDA ANDA073652 Lake Erie Medical DBA Quality Care Products LLC NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 49999-215_fbe88b7c-9ce3-4bfd-ba53-e9b7c8b6a3b5 49999-215 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20110127 ANDA ANDA074132 Lake Erie Medical DBA Quality Care Products LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 49999-216_918744fc-2e74-4ee9-87cf-0cd4e346efae 49999-216 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT TOPICAL 19780214 ANDA ANDA085691 Lake Erie Medical DBA Quality Care Products LLC TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49999-222_758e95db-4d65-484f-925b-965e70e902e9 49999-222 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20120326 ANDA ANDA019137 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 49999-223_b0497216-052b-4284-8da2-9dc75f7659b3 49999-223 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20120326 ANDA ANDA075673 Lake Erie Medical DBA Quality Care Products LLC CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 49999-227_ccc64f09-b121-4e10-9665-3e1f25608dc3 49999-227 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 Lake Erie Medical DBA Quality Care Products LLC TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 49999-228_fb2f3471-0169-4eaa-9a11-c32129ba651b 49999-228 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100901 ANDA ANDA040218 Lake Erie Medical DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 49999-231_f6d92c1c-bc4b-4b27-9d36-5b87c00e1497 49999-231 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20060313 ANDA ANDA077309 Lake Erie Medical DBA Quality Care Products LLC ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 49999-237_7013c9a7-c034-46f5-8e3d-7751e94d6fb5 49999-237 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Lake Erie Medical DBA Quality Care Products LLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 49999-241_907d5019-3804-4e9e-a373-1eb4646f3510 49999-241 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 Lake Erie Medical DBA Quality Care Products LLC WATER 99.05 mL/100mL N 20181231 49999-245_b5fb289f-2fb6-4551-b113-c93ca9bf1027 49999-245 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20130514 ANDA ANDA090637 Lake Erie Medical DBA Quality Care Products LLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 49999-246_c76616cf-31ca-4c57-b299-bbf29ea3e8f5 49999-246 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120308 ANDA ANDA065064 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 49999-248_515af0ba-de00-47da-abcd-3db247bb5a28 49999-248 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 19920731 NDA AUTHORIZED GENERIC NDA019787 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 49999-249_3bf9aa0c-d8c5-46da-af5d-46db557387c7 49999-249 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110131 NDA NDA020699 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49999-251_2c7230a2-dc14-42d1-8100-b0fefcef951c 49999-251 HUMAN PRESCRIPTION DRUG Nystatin nystatin CREAM TOPICAL 20060531 ANDA ANDA065315 Lake Erie Medical DBA Quality Care Products LLC NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 49999-253_5dfd1ccf-fadb-4c39-9ab1-ccfdfa2d2713 49999-253 HUMAN PRESCRIPTION DRUG Alprazolam ALPRAZOLAM TABLET ORAL 20100401 ANDA ANDA074909 Lake Erie Medical DBA Quality Care Products LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 49999-254_c0e8537b-687b-4935-b61b-cbc911c46a73 49999-254 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Lake Erie Medical DBA Quality Care Products LLC NEOMYCIN; POLYMYXIN B; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 49999-265_bf8f09fa-4905-4b1e-85f3-8e8b096d5235 49999-265 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20101013 ANDA ANDA075576 Lake Erie Medical DBA Quality Care Products LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 49999-266_8af38fe8-472d-4e63-9d0e-e0e1a78d467e 49999-266 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110131 ANDA ANDA071195 Lake Erie Medical DBA Quality Care Products LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49999-268_10a61ddb-2969-4e43-91a2-ebf9bdef0a00 49999-268 HUMAN PRESCRIPTION DRUG Tetracaine Hydrochloride Tetracaine Hydrochloride SOLUTION OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER Lake Erie Medical DBA Quality Care Products LLC TETRACAINE HYDROCHLORIDE 5 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 49999-271_5995c9a4-44d3-4713-96d2-d3e516598632 49999-271 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110222 NDA AUTHORIZED GENERIC NDA018279 Lake Erie Medical DBA Quality Care Products LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 49999-280_2d71804c-69f7-4baa-a456-25d122e10ed0 49999-280 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate GEL TOPICAL 20100128 ANDA ANDA064160 Lake Erie Medical DBA Quality Care Products LLC CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 49999-283_dce7b93f-ed76-4b04-8405-3db03489ab9d 49999-283 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 Lake Erie Medical DBA Quality Care Products LLC VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 49999-284_04ad6b46-9783-4447-b790-06a90dc319dc 49999-284 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 Lake Erie Medical DBA Quality Care Products LLC VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 49999-286_cd6775bd-348a-40d8-8a72-21aed918eda8 49999-286 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20120323 ANDA ANDA078955 Lake Erie Medical DBA Quality Care Products LLC PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49999-290_32c254f4-7491-4645-b0d6-3ff9d307cae2 49999-290 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20101108 ANDA ANDA063083 Lake Erie Medical DBA Quality Care Products LLC CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 49999-292_55b378c6-34ee-439d-941f-3ebb4793d63c 49999-292 HUMAN PRESCRIPTION DRUG ZOLOFT SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120403 NDA NDA019839 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 49999-293_05df9651-2ae2-43a8-9061-a92f6e18b8cc 49999-293 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 Lake Erie Medical DBA Quality Care Products LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 49999-297_557b4124-6397-4471-81ec-ab4d2c35bebc 49999-297 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Lake Erie Medical DBA Quality Care Products LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 49999-301_5294ebc7-b54a-4c19-bfbe-d2f032704349 49999-301 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075273 Lake Erie Medical DBA Quality Care Products LLC KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 49999-307_c45557d5-8d2b-4355-8906-9b40ffd705a1 49999-307 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20110225 NDA NDA021153 Lake Erie Medical DBA Quality Care Products LLC ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 49999-311_769ab3f2-fe6b-4896-b2f2-18ac79a85ed6 49999-311 HUMAN PRESCRIPTION DRUG Flurbiprofen Flurbiprofen TABLET, FILM COATED ORAL 20120307 ANDA ANDA074431 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-316_b3dc84c2-b866-4008-9f5d-9ebe5fa0c288 49999-316 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 20110713 NDA NDA020895 Lake Erie Medical DBA Quality Care Products LLC SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 49999-321_fe7d03cf-ca3c-43cb-b344-84bc68a6a303 49999-321 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20100811 ANDA ANDA076265 Lake Erie medical DBA Quality Care Products LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49999-324_2cc7a37a-17ee-4531-8a41-20caa890bc8a 49999-324 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 Lake Erie Medical DBA Quality Care Products LLC AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 49999-328_7a0c7cd7-afc8-454c-b3d2-e379bee256c2 49999-328 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20111219 ANDA ANDA074979 Lake Erie Medical DBA Quality Care Products LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49999-333_92610bec-af36-45e9-ac29-3d93d16bf52f 49999-333 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET ORAL 20120229 ANDA ANDA076794 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 49999-343_09be09a3-b215-4e27-96c1-4a2fa95d78b0 49999-343 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20111214 ANDA ANDA071523 Lake Erie Medical DBA Quality Care Products LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 49999-346_7b0089fb-f3e5-4759-a5ec-952ea6c53699 49999-346 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20120214 ANDA ANDA070920 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49999-347_37e3de25-0e0b-40c2-8f35-7f0f445ee284 49999-347 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride TABLET ORAL 20101123 ANDA ANDA076286 Lake Erie Medical DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 49999-349_bd669c40-51ba-446a-baa0-0fa40978b4e4 49999-349 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 49999-357_f4ed3236-3a27-457d-88dd-3820b81d4fac 49999-357 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Lake Erie Medical DBA Quality Care Products LLC NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 49999-363_32468414-0a23-4196-a590-a6d9e9cc45cf 49999-363 HUMAN PRESCRIPTION DRUG SKELAXIN metaxalone TABLET ORAL 20111214 NDA NDA013217 Lake Erie Medical DBA Quality Care Products LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 49999-371_57b6c5e6-8b4d-461f-af20-f12a9bb48c4a 49999-371 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20111121 ANDA ANDA091549 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-374_0feccef6-a2e3-4c4f-8382-f07d9794b20d 49999-374 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20100401 ANDA ANDA018832 Lake Erie Medical DBA Quality Care Products LLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 49999-375_55b378c6-34ee-439d-941f-3ebb4793d63c 49999-375 HUMAN PRESCRIPTION DRUG ZOLOFT SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120403 NDA NDA019839 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 49999-378_36f891ad-0aad-4453-b58b-dcdff0f4aac1 49999-378 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 20120320 ANDA ANDA064120 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 49999-381_02a7fc5a-de5f-48ce-bb0d-2edeedb72beb 49999-381 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Extended Release SR Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101004 ANDA ANDA075932 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 49999-383_836e2ffd-c264-4ca6-8882-c352941e53bf 49999-383 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 20111122 NDA NDA020998 Lake Erie Medical DBA Quality Care Products LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-388_2a09e420-e0b1-4168-aab0-01ecf2f1cf60 49999-388 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20111121 NDA AUTHORIZED GENERIC NDA020504 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49999-392_02e0c3d4-29da-49b6-a57b-8bc52b005de5 49999-392 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20120305 NDA NDA020702 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 49999-401_986d28a9-030b-4a74-bae4-7ef2c9a74985 49999-401 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070614 ANDA ANDA076345 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 49999-402_0ae01d29-b09b-4d7f-858e-c120da91b6df 49999-402 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 20111213 NDA NDA020839 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 49999-406_d634adab-7540-458d-adee-65a9458d3491 49999-406 HUMAN PRESCRIPTION DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 19950130 ANDA ANDA064028 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 49999-411_f0b73405-3aed-4033-80ca-aadcbb711356 49999-411 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20120326 NDA NDA009218 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 49999-418_a3d5b0f5-ab9d-43f4-b86b-e1cbb5bcd92e 49999-418 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 20110127 NDA NDA020634 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 500 mg/1 E 20171231 49999-419_6f9fd881-5c2c-4925-940c-b3ac3152db3b 49999-419 HUMAN PRESCRIPTION DRUG LIDODERM lidocaine PATCH CUTANEOUS 20051130 NDA NDA020612 Lake Erie Medical DBA Quality Care Products LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 49999-439_eaf89fa3-caec-4a9c-b36e-5e622946cba9 49999-439 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin and Polymyxin B Sulfates and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 20120124 ANDA ANDA064065 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 10; 10000 mg/mL; mg/mL; [USP'U]/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 49999-447_533dbcc4-1c27-4ab8-80cb-d84f68a4634b 49999-447 HUMAN PRESCRIPTION DRUG AcipHex rabeprazole sodium TABLET, COATED ORAL 20120229 NDA NDA020973 Lake Erie Medical & Surgical Supplies DBA Quality Care Products LLC RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 49999-449_4be80657-c3c5-4fc7-bc0a-0dc1ad037e68 49999-449 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 20120217 NDA NDA021073 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 49999-450_4be80657-c3c5-4fc7-bc0a-0dc1ad037e68 49999-450 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 20120217 NDA NDA021073 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 49999-451_4be80657-c3c5-4fc7-bc0a-0dc1ad037e68 49999-451 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 20120217 NDA NDA021073 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 49999-454_9d582f30-72a0-4703-9bec-134b91dad96a 49999-454 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20120418 ANDA ANDA077877 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 49999-455_71f0fbcc-f5df-43e7-a8c2-3f5ebc1b90cd 49999-455 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20111207 NDA NDA021085 Lake Erie Medical DBA Quality Care Products LLC MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 49999-458_c2c69a91-1be5-4ada-a0b9-e40e7fc1c474 49999-458 HUMAN PRESCRIPTION DRUG Evista Raloxifene hydrochloride TABLET ORAL 20120307 NDA NDA020815 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 49999-467_02e0c3d4-29da-49b6-a57b-8bc52b005de5 49999-467 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20120305 NDA NDA020702 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 49999-468_02e0c3d4-29da-49b6-a57b-8bc52b005de5 49999-468 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20120305 NDA NDA020702 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 49999-471_aeed5777-58ca-40ca-a5f3-ddc2e0dc8611 49999-471 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Lake Erie Medical DBA Quality Care Products LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 49999-475_390144bf-d618-46b1-bd9a-928eec27c9a6 49999-475 HUMAN PRESCRIPTION DRUG Niaspan ER Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110207 NDA NDA020381 Lake Erie Medical DBA Quality Care Products LLC NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 49999-476_a32ada5b-8360-4e8d-8d78-2aca82a313ac 49999-476 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20070622 ANDA ANDA077899 Lake Erie Medical DBA Quality Care Products LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 49999-478_f152cfa5-287c-4ce8-88a3-e1e64be76d54 49999-478 HUMAN PRESCRIPTION DRUG Norvasc amlodipine besylate TABLET ORAL 20111122 NDA NDA019787 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 49999-480_f951d5af-8235-4240-a279-3ad98abe47f2 49999-480 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 19950510 NDA NDA020406 Lake Erie Medical DBA Quality Care Products LLC LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 49999-481_b7c3d57f-6d35-415c-abff-444efe2f5da2 49999-481 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20111117 NDA NDA020987 Lake Erie Medical DBA Quality Care Products LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 49999-483_1bf1ee83-3ece-4cee-a0d7-cfd949724f16 49999-483 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 49999-486_15eaad48-7fb2-462c-a00e-5e4615bf4ddc 49999-486 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120320 NDA NDA020487 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 49999-487_6dfd1117-3b04-45e8-a31d-22aba7d856c6 49999-487 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20120319 NDA NDA021445 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] E 20171231 49999-504_23dc0e3a-4a59-4fa5-858b-013328ada178 49999-504 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063181 Lake Erie Medical DBA Quality Care Products LLC MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 49999-505_24c4bcfe-5c8f-4058-a294-77e45fc8024f 49999-505 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20101008 ANDA ANDA063065 Lake Erie Medical DBA Quality Care Products LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 49999-517_688a43cc-84c2-47e6-83bf-73a343706ca5 49999-517 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040876 Lake Erie Medical DBA Quality Care Products PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 49999-520_4efec3eb-da83-40d6-9a6f-8cf9ae2b05d4 49999-520 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20120307 ANDA ANDA077253 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 49999-521_d500f8c3-d133-444d-817b-596d08bbe99e 49999-521 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin calcium CREAM TOPICAL 20120328 NDA NDA050746 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MUPIROCIN CALCIUM 21.5 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 49999-539_0e0b38f6-23b7-4252-bf6a-367f32a5a1d4 49999-539 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100917 ANDA ANDA075350 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 49999-540_85967055-9c54-403a-841f-dcc10509e62a 49999-540 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20101104 ANDA ANDA075350 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 49999-542_3e519781-2cfe-4ef2-b3f1-1caa08488b55 49999-542 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, EXTENDED RELEASE ORAL 19980731 ANDA ANDA075028 Lake Erie Medical DBA Quality Care Products LLC PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] E 20171231 49999-543_648903ce-1832-4d04-a645-01bdff20788f 49999-543 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20111115 NDA NDA021283 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 49999-552_d5f6ab45-dc2c-459e-8c48-db861223e10d 49999-552 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Lake Erie Medical DBA Quality Care Products LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 49999-555_82e01324-9fbd-4a0b-a8c8-12168a73330f 49999-555 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20120323 ANDA ANDA070176 Lake Erie Medical DBA Quality Care Products LLC PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49999-568_c062ac06-2739-4933-b447-35cbeee67efe 49999-568 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20111105 ANDA ANDA078428 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 49999-574_d878ffc7-a553-4949-b0bc-bde2fd1d6e05 49999-574 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20061212 ANDA ANDA040621 Lake Erie Medical DBA Quality Care Products LLC PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 49999-575_94e70902-1849-42df-a565-bc55c1bc71ef 49999-575 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 49999-588_9309c8e8-2168-4fc1-a12f-01fb41fb4d67 49999-588 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20101117 ANDA ANDA076604 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-593_808492b4-a3eb-4a20-9c92-de39181adfbd 49999-593 HUMAN PRESCRIPTION DRUG Diclofenac Potassium diclofenac potassium TABLET, FILM COATED ORAL 20111205 ANDA ANDA075463 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-598_56d26f2d-776e-4000-97db-62b07392fa51 49999-598 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20120217 NDA NDA021436 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 49999-599_cd960c6d-1f04-4a57-95d5-134d3f228d57 49999-599 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110525 NDA NDA020699 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49999-600_1c13d5c6-a213-453a-9768-6cad8e84383b 49999-600 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20111214 NDA NDA021323 Lake Erie Medical DBA Quality Care Products LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49999-602_0deca45f-5003-40e0-b464-ea0905de58ce 49999-602 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20120416 NDA NDA020639 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 49999-603_0deca45f-5003-40e0-b464-ea0905de58ce 49999-603 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20120416 NDA NDA020639 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] E 20171231 49999-606_22ed737e-df95-4780-bf50-5f53ef9887d8 49999-606 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20120330 NDA NDA020592 Lake Erie Medical DBA Quality Care Products LLC OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 49999-607_1656244d-1e72-4ca0-9515-7800f99545f2 49999-607 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100519 ANDA ANDA074584 Lake Erie Medical DBA Quality Care Products LLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 49999-610_b55c729d-06b6-43cd-bb5a-f496eebf1f2a 49999-610 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC GUAIFENESIN; CODEINE PHOSPHATE 100; 10 mg/5mL; mg/5mL CV N 20181231 49999-611_116c17bf-c6e2-4cff-932f-f7f1037594ac 49999-611 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE ORAL 20101012 ANDA ANDA075576 Lake Erie Medical DBA Quality Care Products LLC OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 49999-616_01f75cae-b8fe-4563-ae31-1bb31a3e804a 49999-616 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20091023 ANDA ANDA077272 Lake Erie Medical DBA Quality Care Products LLC CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 49999-618_e8eaffb2-9e64-4c06-8b6d-53af10803849 49999-618 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20110714 NDA NDA021427 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49999-619_e8eaffb2-9e64-4c06-8b6d-53af10803849 49999-619 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20110714 NDA NDA021427 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49999-620_e1e6efcf-60ff-42af-baa5-64d65862c210 49999-620 HUMAN PRESCRIPTION DRUG Geodon Ziprasidone Hydrochloride Monohydrate CAPSULE ORAL 20101105 NDA NDA020825 Lake Erie Medical DBA Quality Care Products LLC ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 49999-621_5c14a19c-0519-4855-9a58-59b686bd0eb8 49999-621 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20120327 NDA NDA020825 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] E 20171231 49999-627_1c13d5c6-a213-453a-9768-6cad8e84383b 49999-627 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20111214 NDA NDA021323 Lake Erie Medical DBA Quality Care Products LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49999-629_2a4c3543-cfd3-4ab3-89a3-6c19704edb0e 49999-629 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Lake Erie Medical DBA Quality Care Products LLC MIRTAZAPINE 15 mg/1 N 20181231 49999-630_8efdc34f-4a69-4d91-a9cd-785ab349ffa8 49999-630 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20100828 ANDA ANDA076119 Lake Erie Medical DBA Quality Care Products LLC MIRTAZAPINE 30 mg/1 N 20181231 49999-631_f62efab2-5fd5-4529-8ccf-74fd4306e52e 49999-631 HUMAN PRESCRIPTION DRUG PAROXETINE Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Lake Erie Medical DBA Quality Care Products LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49999-632_f62efab2-5fd5-4529-8ccf-74fd4306e52e 49999-632 HUMAN PRESCRIPTION DRUG PAROXETINE Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20111108 ANDA ANDA077584 Lake Erie Medical DBA Quality Care Products LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49999-636_5f48f6d9-92c0-4437-b354-5cbe1ac225cf 49999-636 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine CAPSULE ORAL 20100713 NDA NDA021411 Lake Erie Medical DBA Quality Care Products LLC ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 49999-644_38361fc7-4edf-4dd9-a66e-a88ad3df9691 49999-644 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20091030 ANDA ANDA065123 Lake Erie Medical DBA Quality Care Products LLC MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 49999-646_fce94d1c-69de-4bfa-854e-d08a2de7327e 49999-646 HUMAN PRESCRIPTION DRUG CICLOPIROX OLAMINE CICLOPIROX OLAMINE CREAM TOPICAL 20101103 ANDA ANDA077364 Lake Erie Medical DBA Quality Care Products LLC CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 49999-654_4f58f61e-d674-452e-b205-2a42e2925c44 49999-654 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20111122 ANDA ANDA077289 Lake Erie Medical DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49999-656_da108c5b-931a-459f-ac67-ccd8036ce357 49999-656 HUMAN PRESCRIPTION DRUG SULINDAC SULINDAC TABLET ORAL 20100623 ANDA ANDA071795 Lake Erie Medical DBA Quality Care Products LLC SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-692_7d516a2a-4b48-4812-8719-271b2bb31e67 49999-692 HUMAN PRESCRIPTION DRUG GABITRIL tiagabine hydrochloride TABLET ORAL 20111115 NDA NDA020646 Lake Erie Medical & Surgial Supply DBA Quality Care Products LLC TIAGABINE HYDROCHLORIDE 4 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 49999-693_f853d592-5559-4a15-ae0f-679c26f7a977 49999-693 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20111209 ANDA ANDA090485 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 49999-699_55507c53-4bd0-4f5e-bdbc-ffcf8d8f9180 49999-699 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 49999-701_0e10e444-cfe7-4bb9-9f8c-e77a8726aa7a 49999-701 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Lake Erie Medical DBA Quality Care Products LLC HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 49999-711_ca9278a5-e5ea-4109-85ba-7698cbec3deb 49999-711 HUMAN OTC DRUG Senna Plus Senna Plus TABLET ORAL 20120215 OTC MONOGRAPH NOT FINAL part334 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SENNOSIDES A AND B 8.6 mg/1 N 20181231 49999-725_ea13db84-e8d6-4ae6-9f25-4d77cb8ebbb5 49999-725 HUMAN OTC DRUG Non-Habit Forming Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Lake Erie Medical DBA Quality Care Products LLC DOCUSATE SODIUM 100 mg/1 E 20171231 49999-737_95ed9e98-360f-49d9-ae62-1e554f1dc229 49999-737 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20110718 NDA NDA021476 Lake Erie Medical DBA Quality Care Products LLC ESZOPICLONE 3 mg/1 CIV N 20181231 49999-740_e7603afa-7fb0-4de3-b837-814ec8ee3228 49999-740 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 Lake Erie Medical DBA Quality Care Products LLC POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 49999-758_40db2e99-1d21-4df4-bf80-ab14eaacc6f0 49999-758 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19930701 ANDA ANDA072801 Lake Erie Medical DBA Quality Care Products LLC METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 49999-763_b14add9a-30ab-4cf1-b411-4f46d4ea09e7 49999-763 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20111213 NDA NDA021774 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 49999-764_8db8978c-7eaa-4b7f-b6f2-026922a83877 49999-764 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET ORAL 20111110 NDA NDA021774 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 49999-771_c66a14ed-6401-4952-8733-9b4929771ba1 49999-771 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET ORAL 20091209 ANDA ANDA076502 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 49999-772_308aebef-6081-447b-ba14-890825969eee 49999-772 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20050801 ANDA ANDA020872 Lake Erie Medical DBA Quality Care Products LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 49999-774_83884fd4-6a9b-4df5-ae97-5d59a097f766 49999-774 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA021515 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 49999-779_b2535647-00a9-4342-aa15-235bbc2a3fec 49999-779 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20111118 NDA NDA021476 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ESZOPICLONE 2 mg/1 CIV E 20171231 49999-784_319760b6-5234-4587-92b0-967e3627eb78 49999-784 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20111104 ANDA ANDA077662 Lake Erie Medica & Surgical Supply DBA Quality Care Products LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 49999-785_55b09832-cae7-497a-bcfb-eee4d5b65857 49999-785 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20030725 ANDA ANDA065135 Lake Erie Medical DBA Quality Care Products LLC CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 49999-791_681e814e-2608-45fa-a9e5-c766d60ac78c 49999-791 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120202 ANDA ANDA071611 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 49999-797_34fc7137-d495-417b-abde-e8cc0726f19b 49999-797 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 49999-799_6624ed11-53f2-4232-8598-3e13ed8790f2 49999-799 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20101206 ANDA ANDA077662 Lake Erie Medical & Surgical S6758upply DBA Quality Care Products LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 49999-800_7a72b026-532a-4744-a8ae-f06267d6c1a4 49999-800 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20040419 ANDA ANDA074623 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 49999-805_be299d89-60e6-42f1-9213-f65dc524fa92 49999-805 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20111117 ANDA ANDA072926 Lake Erie Medical DBA Quality Care Products LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 49999-811_f8463b5d-350c-4c4b-b05d-95ec3b168fa0 49999-811 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Lake Erie Medical DBA Quality Care Products LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 49999-812_a62ed0d3-f41c-4b00-b141-70dd4eb44fdf 49999-812 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101116 ANDA ANDA074253 Lake Erie Medical DBA Quality Care Products LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 49999-815_1539e354-7334-4e81-a18e-b4233e00c85c 49999-815 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20120222 NDA NDA021286 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 49999-816_56d26f2d-776e-4000-97db-62b07392fa51 49999-816 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20120217 NDA NDA021436 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 49999-817_28f0dea2-4ea7-4d31-a4a7-907e412e11e8 49999-817 HUMAN PRESCRIPTION DRUG Abilify Aripiprazole TABLET ORAL 20100603 NDA NDA021436 Lake Erie Medical DBA Quality Care Products LLC ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] E 20171231 49999-818_d674cdc7-ba5b-4509-a365-baae3cc6ea02 49999-818 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20110728 NDA NDA021436 Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 49999-819_2eb360bb-9b05-4fcf-b368-48283c3a9fca 49999-819 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20120217 NDA NDA021077 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 250 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 49999-820_213ec3de-1f1d-4399-adf6-18b445a058bf 49999-820 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040616 ANDA ANDA076172 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 49999-823_c9f1d3d8-b65a-449b-9ec0-edfe6355e38b 49999-823 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090723 ANDA ANDA076486 Lake Erie Medical DBA Quality Care Products LLC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49999-828_f261b7f8-57d6-4113-a46e-cc4ef18b2930 49999-828 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 49999-831_9eca5036-8a29-4890-b271-5e51dcfe3b1b 49999-831 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20111209 ANDA ANDA076709 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 25 ug/72h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49999-832_9eca5036-8a29-4890-b271-5e51dcfe3b1b 49999-832 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20111209 ANDA ANDA076709 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 50 ug/72h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49999-833_2e8cec25-4507-41cf-ae44-aa6c158d5d11 49999-833 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20111209 ANDA ANDA076709 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FENTANYL 7.5 mg/72h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49999-834_9eca5036-8a29-4890-b271-5e51dcfe3b1b 49999-834 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20111209 ANDA ANDA076709 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 100 ug/72h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49999-839_b4e3d741-8f72-4cce-be1e-50408db9b382 49999-839 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20120206 ANDA ANDA040517 Lake Erie Medical DBA Quality Care Products LLC METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49999-839_d07edc62-5515-4b83-b4c4-c5dc6c95aaf2 49999-839 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20101011 ANDA ANDA040517 Lake Erie Medical DBA Quality Care Products LLC METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49999-844_d6e66612-57de-4712-a85d-b3a03e5b9003 49999-844 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20100915 ANDA ANDA040220 Lake Erie Medical DBA Quality Care Products LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 49999-845_6eedbed7-e74d-4eeb-8362-5f8272128217 49999-845 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, EXTENDED RELEASE ORAL; ORAL 20100917 ANDA ANDA075295 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49999-845_82528d8c-dd19-4861-9344-8c83ac2a962a 49999-845 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, EXTENDED RELEASE ORAL; ORAL 20100917 ANDA ANDA075295 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49999-846_76068868-db8a-4252-a422-cb76087a47a7 49999-846 HUMAN PRESCRIPTION DRUG Morphine Sulfate ER Morphine Sulfate TABLET ORAL 20100812 ANDA ANDA076438 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49999-846_faa7d020-60db-4c79-8fca-2887e48f3fe3 49999-846 HUMAN PRESCRIPTION DRUG Morphine SulfateER ER Morphine Sulfate TABLET ORAL 20100407 ANDA ANDA076438 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49999-847_98e7839d-d75f-4a8b-9ecd-09a04af593ad 49999-847 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET ORAL 20100828 ANDA ANDA076438 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49999-847_e32d0192-7da9-4563-869c-ab835b2d4dc2 49999-847 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET ORAL 20100819 ANDA ANDA076438 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49999-848_dadb8114-f39a-48eb-bacd-238e52a3357a 49999-848 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20120319 NDA NDA022207 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49999-849_df88b967-cf31-4714-a180-75bbe8d9d0b5 49999-849 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20111213 NDA NDA022195 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49999-850_8e2e4990-5938-4513-988d-c395e32deb76 49999-850 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20120214 ANDA ANDA076758 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49999-852_33ebe0f4-06ee-413b-a706-abfe1fd01c39 49999-852 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20100610 ANDA ANDA087463 Lake Erie Medical DBA Quality Care products LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49999-853_c9bd4376-b77d-483d-af96-1c0e9920aac0 49999-853 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20111115 ANDA ANDA040535 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49999-856_12f20ab6-a011-4785-a518-b8ced96410e6 49999-856 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19951201 NDA NDA022272 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49999-857_28987a0c-43ef-481a-afc8-c6af282200ef 49999-857 HUMAN PRESCRIPTION DRUG Oxycontin Oxycodone Hydrochloride TABLET ORAL 20100828 NDA NDA020553 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 49999-860_ec057887-c4e1-4907-81f6-257eaf07e8a6 49999-860 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111107 NDA AUTHORIZED GENERIC NDA019839 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 49999-861_ec057887-c4e1-4907-81f6-257eaf07e8a6 49999-861 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111107 NDA AUTHORIZED GENERIC NDA019839 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 49999-868_0f6f2f59-7826-4ed0-95f0-3b5581314610 49999-868 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20111107 ANDA ANDA077918 Lake Erie Medical DBA Quality Care Products LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-869_1af3bdaa-a50e-4673-876a-f3ac1f1c91ce 49999-869 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100917 ANDA ANDA077927 Lake Erie Medical DBA Quality Care Products LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-870_cd98b981-61d2-4870-8eca-82f92bc9d693 49999-870 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20070215 ANDA ANDA077321 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 49999-872_5a4dec4b-ebdd-484e-aa42-2060f27f2343 49999-872 HUMAN PRESCRIPTION DRUG COREG carvedilol TABLET, FILM COATED ORAL 20111121 NDA NDA020297 Lake Erie Medical DBA Quality Care Products LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 49999-873_53a2af25-fd90-46f0-b0c1-60399e543ff2 49999-873 HUMAN PRESCRIPTION DRUG Crestor Rosuvastatin calcium TABLET, COATED ORAL 20101109 NDA NDA021366 Lake Erie Medical DBA Quality Care Products LLC ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 49999-876_8404295c-5f7f-46e6-8f69-a1629c38ab1e 49999-876 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 Lake Erie Medical DBA Quality Care Products LLC PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 49999-877_13a8217d-9554-4885-8ec6-1498f82c5734 49999-877 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20120228 NDA NDA021283 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 49999-878_13a8217d-9554-4885-8ec6-1498f82c5734 49999-878 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20120228 NDA NDA021283 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 49999-879_c689c7c6-4d37-4b5e-919f-49da9125e4b5 49999-879 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20111115 NDA NDA020818 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 49999-880_39a06fb8-9987-4cb8-8fd3-883e8000ec6a 49999-880 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120228 NDA NDA020818 Lake Erie Medical DBA Quality Care Products LLC VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 49999-881_a1cc795d-6be7-44d3-9e66-a2a6ca6c0cf5 49999-881 HUMAN PRESCRIPTION DRUG Flomax Flomax CAPSULE ORAL 20100513 NDA NDA020579 Lake Erie Medical DBA Quality Care Products TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 49999-882_02e0c3d4-29da-49b6-a57b-8bc52b005de5 49999-882 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20120305 NDA NDA020702 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 49999-885_3a198a09-0cf3-449c-9c64-8530cb29b8a9 49999-885 HUMAN PRESCRIPTION DRUG Tricor Fenofibrate TABLET ORAL 20120320 NDA NDA021656 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 49999-886_bb51375f-7929-420f-8209-630916f85324 49999-886 HUMAN PRESCRIPTION DRUG FLUOXETINE fluoxetine hydrochloride CAPSULE ORAL 20111107 ANDA ANDA076922 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 49999-889_2efb9b2d-cbed-42cc-baba-b255796c31cc 49999-889 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111122 ANDA ANDA077691 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 49999-895_0488a4b1-3f25-4625-9105-a951820f31f8 49999-895 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20110210 NDA NDA021724 Lake Erie Medical DBA Quality Care Products LLC PREGABALIN 75 mg/1 CIV N 20181231 49999-896_f7825d82-44f7-40ae-a394-9a5e14e7e459 49999-896 HUMAN PRESCRIPTION DRUG Ultram ER Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 NDA NDA021692 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 49999-897_94b1b49f-32b5-4b63-b1c1-11a87ddb5ef8 49999-897 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20110203 ANDA ANDA075227 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-899_5fb1d43d-c286-436f-b46f-ee73f23d3eb4 49999-899 HUMAN PRESCRIPTION DRUG Oxycodone Hydchloride Oxycodone Hydchloride TABLET ORAL 20111220 ANDA ANDA091393 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 49999-904_d53ca0b3-95e2-44a7-abf1-c3e3a89af7c7 49999-904 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20101115 ANDA ANDA065136 Lake Erie Medical DBA Quality Care Products LLC CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 49999-905_0ec72d6f-10c9-4e35-b400-22be3a1e7098 49999-905 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20120206 NDA NDA021724 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC PREGABALIN 100 mg/1 N 20181231 49999-906_18314e7c-8ded-416f-acff-6c7d8d519a11 49999-906 HUMAN PRESCRIPTION DRUG Lyrica Pregabalin CAPSULE ORAL 20100927 NDA NDA021724 Lake Erie Medical DBA Quality Care Products LLC PREGABALIN 200 mg/1 CV N 20181231 49999-907_9cbbbdf3-5e8a-4077-a42d-f1c4dd3d17fb 49999-907 HUMAN PRESCRIPTION DRUG Proventil HFA Albuterol Sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20011001 NDA NDA020503 Lake Erie Medical DBA Quality Care Products LLC ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 49999-908_4c7bf665-30aa-4db8-a720-2bad24e02a06 49999-908 HUMAN PRESCRIPTION DRUG PROAIR HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20120321 NDA NDA021457 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 49999-913_09be09a3-b215-4e27-96c1-4a2fa95d78b0 49999-913 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Lake Erie Medical DBA Quality Care Products LLC TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 49999-914_d2272b86-d84d-42e9-81aa-93dfe93b3106 49999-914 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961111 ANDA ANDA070848 Lake Erie Medical DBA Quality Care Products LLC SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 49999-915_79a25c8f-4c75-47e3-83a2-51edee8846fd 49999-915 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20111205 ANDA ANDA073555 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 49999-916_0c4baa20-6def-4135-b496-3f2440c549a8 49999-916 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20120316 ANDA ANDA074377 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC MEXILETINE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] E 20171231 49999-918_1c50448f-3189-4da8-b10e-b7c5e2a8ff25 49999-918 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 49999-924_f07957fa-ae4c-428b-8189-668e25053dc9 49999-924 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060927 ANDA ANDA077912 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 49999-928_1012017d-1f8f-4e91-8858-813a3f5e319b 49999-928 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20041208 ANDA ANDA076925 Lake Erie Medical DBA Quality Care Products LLC IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 49999-931_1d49a704-4cec-4f82-a326-24aef9d01f88 49999-931 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20110415 ANDA ANDA078616 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 49999-932_be58a296-dc68-480e-93f7-90868fc0941b 49999-932 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20111107 ANDA ANDA078616 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 49999-936_dedb1efa-4833-4483-a055-b5d3cc735223 49999-936 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil CAPSULE ORAL 20111129 NDA NDA050722 Lake Erie Medical DBA Quality Care Products LLC MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 49999-937_ec4d064b-7e0a-49b7-89f2-d8c0787b52e9 49999-937 HUMAN PRESCRIPTION DRUG CellCept Mycophenolate Mofetil TABLET, FILM COATED ORAL 19970619 NDA NDA050723 Lake Erie Medical DBA Quality Care Products LLC MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 49999-943_39a06fb8-9987-4cb8-8fd3-883e8000ec6a 49999-943 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120228 NDA NDA020818 Lake Erie Medical DBA Quality Care Products LLC VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 49999-949_998c886d-bc5c-4d5e-a30f-58398d776c84 49999-949 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20111108 NDA NDA021724 Lake Erie Medical & Surgical Supply, DBA Quality Care Products, LLC PREGABALIN 50 mg/1 CIV N 20181231 49999-951_e8432823-6d78-461e-b5e2-64552809e122 49999-951 HUMAN PRESCRIPTION DRUG Seroquel Quetiapine Fumarate TABLET, FILM COATED ORAL 20100708 NDA NDA020639 Lake Erie Medical DBA Quality Care Products LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 49999-957_74e37778-f545-4590-bc96-07fdb5d6ff9c 49999-957 HUMAN PRESCRIPTION DRUG Vytorin Ezetimibe Simvastin TABLET ORAL 20100927 NDA NDA021687 Lake Erie Medical DBA Quality Care Products LLC EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 49999-958_434bf376-4331-444a-a925-9f1e8bff3c36 49999-958 HUMAN PRESCRIPTION DRUG Vytorin Ezetimibe/Simvastin TABLET ORAL 20100827 NDA NDA021687 Lake Erie Medical DBA Quality Care Products LLC EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 49999-982_983cdbf8-d9d3-45f9-a6ef-0898b86c059c 49999-982 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20120312 ANDA ANDA077570 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 49999-983_fe3bd3c9-25a7-47b7-8623-22b4ee444729 49999-983 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 49999-984_2eb360bb-9b05-4fcf-b368-48283c3a9fca 49999-984 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20120217 NDA NDA021077 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 100 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 49999-985_2eb360bb-9b05-4fcf-b368-48283c3a9fca 49999-985 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20120217 NDA NDA021077 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 500 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 49999-987_4328ede8-499a-446b-9d76-8809a2258eb2 49999-987 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 20120223 NDA NDA020607 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 49999-992_a1d421a7-73ea-4bb6-99f5-b4529d360daf 49999-992 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20120227 NDA NDA021366 Lake Erie Medical & Surgucal Supply DBA Quality Care Products LLC ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 50001-111_347f2743-075b-46c7-82ad-19e4d5ba42b3 50001-111 HUMAN OTC DRUG Level Anticavity SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20091230 OTC MONOGRAPH NOT FINAL part355 Level Oral Care, LLC SODIUM MONOFLUOROPHOSPHATE 76 g/100g N 20181231 50001-121_bec980cf-92d7-4c5c-bce8-1da7113cfc08 50001-121 HUMAN OTC DRUG LEVEL WINTERMINT FIVE WHITENING FORMULA ANTICAVITY SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100816 OTC MONOGRAPH FINAL part356 LEVEL ORAL CARE, LLC SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 50001-131_acbdcd4b-ada1-4f89-9046-428b73844128 50001-131 HUMAN OTC DRUG LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100812 OTC MONOGRAPH FINAL part356 LEVEL ORAL CARE, LLC POTASSIUM NITRATE; SODIUM MONOFLUOROPHOSPHATE 5; .76 g/100g; g/100g N 20181231 50007-1000_062f4b65-ebd4-4dd5-a3ba-3e7c1995c8ae 50007-1000 HUMAN OTC DRUG Lactovit Original Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20091216 OTC MONOGRAPH FINAL part350 Antonio Puig, S.A. ALUMINUM CHLOROHYDRATE 15 mL/100mL E 20171231 50007-2000_0a4436d5-8d69-4a97-bec2-16b378a9334c 50007-2000 HUMAN OTC DRUG Lactovit Sensitive Skin Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20091216 OTC MONOGRAPH FINAL part350 Antonio Puig, S.A. ALUMINUM CHLOROHYDRATE 10 mL/100mL E 20171231 50007-3000_bb3c62cb-a3de-4296-a8fc-129da58170eb 50007-3000 HUMAN OTC DRUG Lactovit Men Roll-On Antiperspirant Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20091216 OTC MONOGRAPH FINAL part350 Antonio Puig, S.A. ALUMINUM CHLOROHYDRATE 15 mL/100mL E 20171231 50014-100_5b5b7a7c-6d8e-e147-e053-2991aa0aa499 50014-100 HUMAN OTC DRUG Antibacterial Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333E Xi'an Livingbond Nonwoven Products Corp., Ltd. BENZALKONIUM CHLORIDE .1 1/1 N 20181231 50014-110_5f16a2f9-1487-2f8f-e053-2991aa0aad65 50014-110 HUMAN OTC DRUG Antibacterial Wet Benzalkonium Chloride LIQUID TOPICAL 20171127 OTC MONOGRAPH NOT FINAL part333E Xi'an Livingbond Nonwoven Products Corp., Ltd. BENZALKONIUM CHLORIDE .3 g/100g N 20181231 50017-020_b972fec1-ac0a-45fd-8a73-ada973845c25 50017-020 HUMAN OTC DRUG Foot Saver Antiperspirant GEL TOPICAL 20130328 OTC MONOGRAPH FINAL part350 Neat Feat Products Limited ALUMINUM CHLOROHYDRATE 13.5 g/60mL N 20181231 50017-022_4b17b0ca-e73c-46e6-9f0c-da97a5028a7c 50017-022 HUMAN OTC DRUG Bodysaver skin protectant CREAM TOPICAL 20130407 OTC MONOGRAPH FINAL part347 Neat Feat Products Limited ZINC ACETATE .15 g/75g N 20181231 50017-023_f4244448-e528-42f7-bb11-4790af8f74e3 50017-023 HUMAN OTC DRUG Action Cream skin protectant CREAM TOPICAL 20130407 OTC MONOGRAPH FINAL part347 Neat Feat Products Limited ZINC ACETATE .15 g/75g E 20171231 50017-024_a6b2aa68-6158-4c14-8250-3f254c93a8be 50017-024 HUMAN OTC DRUG Face Saver Gel Antiperspirant GEL TOPICAL 20130328 OTC MONOGRAPH FINAL part350 Neat Feat Products Limited ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 8.75 g/g N 20181231 50017-025_b7359404-7df9-4830-b298-7acf5d630b02 50017-025 HUMAN OTC DRUG Hand Saver Antiperspirant LOTION TOPICAL 20130328 OTC MONOGRAPH FINAL part350 Neat Feat Products Limited ALUMINUM CHLOROHYDRATE 11 g/50g N 20181231 50017-026_2dba96ab-82e8-46a0-a4f3-64fb3a5084f6 50017-026 HUMAN OTC DRUG BabyB BabySaver skin protectant CREAM TOPICAL 20130407 OTC MONOGRAPH FINAL part347 Neat Feat Products Limited ZINC ACETATE 1 g/50g N 20181231 50017-027_560cd43e-d36d-4db5-b0d2-65c562436ae0 50017-027 HUMAN OTC DRUG BabyB BabySaver skin protectant CREAM TOPICAL 20130407 OTC MONOGRAPH FINAL part347 Neat Feat Products Limited ZINC ACETATE 15 g/150g N 20181231 50021-016_4ce56875-4b80-471f-8124-0c24d65329b8 50021-016 HUMAN OTC DRUG Sunzone Family SPF 15 Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTINOXATE; AVOBENZONE 2.35; 1.18 g/235g; g/235g E 20171231 50021-061_a3e1687e-55ea-46bd-888b-76ae21b21dbb 50021-061 HUMAN OTC DRUG SUNZONE KIDS SPF 60 Broad Spectrum Octinoxate, Octocrylene, Octisalate, Oxybenzone, Avobenzone and Homosalate. AEROSOL, SPRAY TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE; HOMOSALATE 7.75; 7.75; 7.75; 9.3; 4.65; 18.6 g/155g; g/155g; g/155g; g/155g; g/155g; g/155g E 20171231 50021-062_fb7fc079-c9bc-4469-b5b2-f3fc32876844 50021-062 HUMAN OTC DRUG SUNZONE FAMILY SPF 60 Broad Spectrum Octinoxate, Octocrylene, Octisalate, Oxybenzone, Avobenzone and Homosalate. AEROSOL, SPRAY TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE; HOMOSALATE 7.75; 7.75; 7.75; 9.3; 4.65; 18.6 g/155g; g/155g; g/155g; g/155g; g/155g; g/155g E 20171231 50021-065_da941e21-1a79-11e0-ac64-0800200c9a66 50021-065 HUMAN OTC DRUG ZYTEC Germ Buster Hand Sanitizer Ethanol GEL TOPICAL 20110128 OTC MONOGRAPH NOT FINAL part356 Empack ETHANOL 143 g/238g E 20171231 50021-080_da941e20-1a79-11e0-ac64-0800200c9a66 50021-080 HUMAN OTC DRUG ZYTEC GERM BUSTER HAND SANITIZER ETHANOL AEROSOL, SPRAY TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part356 Empack ETHANOL 224 g/400g E 20171231 50021-144_38676290-f5ea-470f-bf1c-7c4fce8b059d 50021-144 HUMAN OTC DRUG SUNZONE FAMILY SUNSCREEN SPF 30 Broad Spectrum Octinoxate, Octocrylene, Octisalate, Oxybenzone, Avobenzone and Homosalate. AEROSOL, SPRAY TOPICAL 20121108 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE; HOMOSALATE 11.48; 11.48; 7.65; 6.12; 4.59; 2.4 g/153g; g/153g; g/153g; g/153g; g/153g; g/153g E 20171231 50021-151_84c7e96a-ba3d-4eaa-bce0-eb882e5bf6c7 50021-151 HUMAN OTC DRUG SunZone Kids SPF 45 Broad Spectrum Octocrylene, Octisalate, Homosalate, Avobenzone and Oxybenzone AEROSOL, SPRAY TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 3; 7.5; 15; 3; 7.5 g/150g; g/150g; g/150g; g/150g; g/150g E 20171231 50021-152_2a410231-4b49-4f62-aa30-d5ea47e6e37c 50021-152 HUMAN OTC DRUG SunZone Family SPF 45 Broad Spectrum Octocrylene, Octisalate, Homosalate, Avobenzone and Oxybenzone AEROSOL, SPRAY TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 3; 7.5; 15; 3; 7.5 g/150g; g/150g; g/150g; g/150g; g/150g E 20171231 50021-234_89797ab4-0766-4f9b-b313-e59b02004923 50021-234 HUMAN OTC DRUG SunZone SPF-60 Broad Spectrum Avobenzone and Octinoxate LOTION TOPICAL 20121113 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTINOXATE; AVOBENZONE 9.36; 7.02 g/234g; g/234g E 20171231 50021-235_84b3de68-9b88-46d9-9234-a13925f2ec56 50021-235 HUMAN OTC DRUG SunZone Family SPF 30 Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc OCTINOXATE; AVOBENZONE 4.7; 1.76 g/235g; g/235g E 20171231 50021-236_104b8f3e-77e1-4967-aa67-246613a39410 50021-236 HUMAN OTC DRUG SunZone Sport SPF 30 Sunscreen Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc OCTINOXATE; AVOBENZONE 4.7; 1.76 g/235g; g/235g E 20171231 50021-237_acb4d88f-ad55-43ab-866d-daf227fa9307 50021-237 HUMAN OTC DRUG SunZone Baby SPF 30 Sunscreen Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc OCTINOXATE; AVOBENZONE 4.7; 1.76 g/235g; g/235g E 20171231 50021-240_9b5a15c9-f298-4b95-89c6-1b12b775a941 50021-240 HUMAN OTC DRUG SunZone Work Sunscreen SPF-60 Broad Spectrum Avobenzone and Octinoxate LOTION TOPICAL 20121113 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTINOXATE; AVOBENZONE 9.36; 7.02 g/234g; g/234g E 20171231 50021-241_4805c9e5-d7eb-4433-aeb4-af9e2e5a53f6 50021-241 HUMAN OTC DRUG SunZone Baby Sunscreen SPF-60 Broad Spectrum Avobenzone and Octinoxate LOTION TOPICAL 20121113 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTINOXATE; AVOBENZONE 9.36; 7.02 g/234g; g/234g E 20171231 50021-242_645c0701-8d41-47ec-a3c1-d9d86f0475d0 50021-242 HUMAN OTC DRUG SunZone Sport Sunscreen SPF-60 Broad Spectrum Avobenzone and Octinoxate LOTION TOPICAL 20121113 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTINOXATE; AVOBENZONE 9.36; 7.02 g/234g; g/234g E 20171231 50021-243_da5f3a12-80ff-4afe-9a71-ac276041cfa1 50021-243 HUMAN OTC DRUG SunZone Family Sunscreen SPF-60 Broad Spectrum Avobenzone and Octinoxate LOTION TOPICAL 20121113 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTINOXATE; AVOBENZONE 9.36; 7.02 g/234g; g/234g E 20171231 50021-300_7fc98345-9dca-4511-ad3e-c1a0d977c8e0 50021-300 HUMAN OTC DRUG SunZone Kids SPF 30 Sunscreen Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc OCTINOXATE; AVOBENZONE 4.7; 1.76 g/235g; g/235g E 20171231 50021-301_4d17b269-7bb8-41ea-b188-8976ae6377cf 50021-301 HUMAN OTC DRUG SUNZONE SPORT SUNSCREEN SPF 30 Broad Spectrum Octisalate, Oxybenzone, Avobenzone and Homosalate. AEROSOL, SPRAY TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTISALATE; OXYBENZONE; AVOBENZONE; HOMOSALATE 7.55; 6.04; 3.02; 22.65 g/151g; g/151g; g/151g; g/151g E 20171231 50021-302_93f40589-36c8-40cc-b8fb-243fd6ddfea8 50021-302 HUMAN OTC DRUG SunZone Sunscreen Sport SPF 45 Broad Spectrum Octocrylene, Octisalate, Homosalate, Avobenzone and Oxybenzone AEROSOL, SPRAY TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 3; 7.5; 15; 3; 7.5 g/150g; g/150g; g/150g; g/150g; g/150g E 20171231 50021-304_e93c22e7-f25d-4c70-a9c5-470747f547f2 50021-304 HUMAN OTC DRUG Sunzone Sunscreen Sport SPF 15 Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20121217 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTINOXATE; AVOBENZONE 2.35; 1.18 g/235g; g/235g E 20171231 50021-305_f08b93f6-e2dd-4457-b043-afb802ddcdc6 50021-305 HUMAN OTC DRUG Sunzone Sunscreen Sport SPF 60 Broad Spectrum Octinoxate, Octocrylene, Octisalate, Oxybenzone, Avobenzone and Homosalate. AEROSOL, SPRAY TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE; HOMOSALATE 7.75; 7.75; 7.75; 9.3; 4.65; 18.6 g/155g; g/155g; g/155g; g/155g; g/155g; g/155g E 20171231 50021-306_b36d5ad3-c720-4e6b-abee-c4a7294c701d 50021-306 HUMAN OTC DRUG SunZone Sunscreen Kids SPF 60 Broad Spectrum Avobenzone and Octinoxate LOTION TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTINOXATE; AVOBENZONE 9.36; 7.02 g/234g; g/234g E 20171231 50021-307_62e4970f-149c-4188-9652-eb487232685f 50021-307 HUMAN OTC DRUG SunZone Sunscreen Family SPF 30 Broad Spectrum Octisalate, Oxybenzone, Avobenzone and Homosalate. AEROSOL, SPRAY TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc. OCTISALATE; OXYBENZONE; AVOBENZONE; HOMOSALATE 7.55; 6.04; 3.02; 22.65 g/151g; g/151g; g/151g; g/151g E 20171231 50021-508_bf716762-2dd4-4e3e-bdc1-cab9edf0326a 50021-508 HUMAN OTC DRUG SunZone Sunscreen Family SPF 30 Broad Spectrum Octinoxate and Avobenzone LOTION TOPICAL 20130102 OTC MONOGRAPH NOT FINAL part352 Empack Spraytech Inc OCTINOXATE; AVOBENZONE 4.7; 1.76 g/235g; g/235g E 20171231 50025-1001_9a69d03e-bf9e-4c24-9e02-b7a2ba4b4500 50025-1001 HUMAN OTC DRUG DANCHUN JADE oriental herb cosmetics GLYCERIN LIQUID TOPICAL 20091101 OTC MONOGRAPH FINAL part347 UniqueInternational Co, Ltd GLYCERIN 1 kg/20kg E 20171231 50030-001_9df32819-4a8f-4271-8be6-eb1af7ca2357 50030-001 HUMAN OTC DRUG GEM BEAUTY AMETHYST INTENSIVE FIRMING EYE CREAM ALOE VERA FLOWER CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part310.545 GEMPARK CO LTD ALOE VERA FLOWER 5.4 mL/30mL E 20171231 50030-003_15aac30d-fbe4-493f-ad9e-7d6aeb3e84a7 50030-003 HUMAN OTC DRUG GEM BEAUTY AMETHYST REJUVENATION CREAM ALOE VERA FLOWER CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part310.545 GEMPARK CO LTD ALOE VERA FLOWER 9.15 mL/50mL E 20171231 50030-004_38e58c7a-aff7-46ce-8c3e-ba042531a5d6 50030-004 HUMAN OTC DRUG GEM BEAUTY AMETHYST PERFECT SOLUTION BB CREAM ALOE FEROX LEAF CREAM TOPICAL 20091201 OTC MONOGRAPH FINAL part310.545 GEMPARK CO LTD ALOE FEROX LEAF 6.65 g/50g E 20171231 50036-514_a1c2ade4-3511-4214-be58-9da4c5eb3108 50036-514 HUMAN OTC DRUG Fikes Northwest Non-Alcohol Foaming Instant Hand Sanitizer Husky 514 SOLUTION TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part333 Fikes Northwest, Corp. BENZALKONIUM CHLORIDE 1 g/1000mL E 20171231 50036-515_bf64ef1f-5fc1-47ba-92dd-48061e8a866e 50036-515 HUMAN OTC DRUG FIKES INSTANT HAND SANITIZER alcohol GEL TOPICAL 20100721 OTC MONOGRAPH NOT FINAL part333 Fikes Northwest, Corp. ALCOHOL 600 mL/1000mL E 20171231 50036-571_077f6779-3d56-4283-be25-8de99e7f4af0 50036-571 HUMAN OTC DRUG FIKES Foaming Anti-Microbial Food Service Hand Wash chloroxylenol LIQUID TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333E Fikes Northwest, Corp. CHLOROXYLENOL 15.75 g/1000mL E 20171231 50048-012_d22ef9b8-fd49-42c4-995c-ab4c5e3ef8a1 50048-012 HUMAN OTC DRUG Kidney Stone Clear Berberis vulg, Calc carb, Cantharis, Lycopodium, Belladonna TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC W. Last CC BERBERIS VULGARIS FRUIT; CALCIUM CARBONATE; LYTTA VESICATORIA; LYCOPODIUM CLAVATUM SPORE; ATROPA BELLADONNA 6; 6; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 50048-015_bda02f69-7328-4cc8-9849-87fdc357c2b4 50048-015 HUMAN OTC DRUG ORAL ASSIST ORAL ASSIST TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC W LAST CC SALICYLIC ACID; SILICON DIOXIDE; BELLADONNA LEAF; MERCURIUS SOLUBILIS; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE 6; 6; 30; 12; 6; 12 [hp_C]/33.33mg; [hp_X]/33.33mg; [hp_C]/33.33mg; [hp_C]/33.33mg; [hp_X]/33.33mg; [hp_C]/33.33mg E 20171231 50048-138_f6e41cb3-c146-456d-9843-08ea53c43dbb 50048-138 HUMAN OTC DRUG Arnica Complex Arnica Montana TABLET ORAL 20091111 UNAPPROVED HOMEOPATHIC W Last CC ARNICA MONTANA 6 [hp_X]/1 E 20171231 50051-0001_c41d549d-9876-4de2-b35f-728c9d919ba2 50051-0001 HUMAN OTC DRUG Ariel Sun Smacker SPF 24 Strawberry Kiwi OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0002_36b6d2c0-b068-491b-87d0-529fb985ff57 50051-0002 HUMAN OTC DRUG Flounder Sun Smacker SPF 24 Watermelon Wave OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0003_61de5d4d-47d0-45bb-9129-608221978b92 50051-0003 HUMAN OTC DRUG Sebastian Sun Smacker SPF 24 Calypso Berry Beat OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0004_55ab1771-f287-4202-bb1a-ccc71a1b57f2 50051-0004 HUMAN OTC DRUG Donald Duck Sun Smacker SPF 24 Tropical Touchdown OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0005_157aa76a-7532-457d-9245-b575406212fe 50051-0005 HUMAN OTC DRUG Goofy Sun Smacker SPF 24 Berry Goal OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0006_1809a22c-3840-4d8c-83d0-211964a3c958 50051-0006 HUMAN OTC DRUG Mickey Sun Smacker SPF 24 Classic Sherbet OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0007_9986ca1b-b906-491d-97b8-62efc88b4998 50051-0007 HUMAN OTC DRUG Mickey Sun Smacker SPF 24 Classic Strawberry OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0008_717b9d65-5755-4c18-b8aa-b8773c9bbac6 50051-0008 HUMAN OTC DRUG Mickey Sun Smacker SPF 24 Classic Vanilla OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0009_74a1bec1-d18c-4ee1-9d4e-dcddb151fb7d 50051-0009 HUMAN OTC DRUG Mickey Sun Smacker SPF 24 Home Run Star Fruit OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0010_40efbbc3-9043-4d93-ae59-201297eaf787 50051-0010 HUMAN OTC DRUG Lightning McQueen Sun Smacker SPF 24 Revved Up Raspberry OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0011_82217fee-8d08-4b92-975a-a9e8f5742355 50051-0011 HUMAN OTC DRUG Tow Mater Sun Smacker SPF 24 Tow-Tally Orange OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0012_3b2bfa0e-90ae-4420-848d-41b2e5d17c3a 50051-0012 HUMAN OTC DRUG Fin McMissie Sun Smacker SPF 24 Vroom Vroom Vanilla OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0013_173b8d28-812f-499d-984e-aec4d17de752 50051-0013 HUMAN OTC DRUG Phineas and Ferb Sun Smacker SPF 24 Berry Busted OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0014_00ac9d57-dd1a-4312-bed0-ab575f851fa9 50051-0014 HUMAN OTC DRUG Phineas and Ferb Sun Smacker SPF 24 Secret Agent Strawberry OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0015_f44cc17c-bb7d-49ce-95c6-7c1746cd6316 50051-0015 HUMAN OTC DRUG Phineas and Ferb Sun Smacker SPF 24 Vanilla Vacation OCTINOXATE, OXYBENZONE, PADIMATE O LIPSTICK TOPICAL 20120906 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0016_0bfe070d-bca0-47c0-9b7d-bd5524918de7 50051-0016 HUMAN OTC DRUG Lip Smacker SPF 24 Cool Strawberry Orange OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0017_1d76301f-bf65-4393-9481-7fcbd62192f5 50051-0017 HUMAN OTC DRUG Lip Smacker SPF 24 Vanilla Ice OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0018_718df646-b00e-447b-947c-b451dd8d72d8 50051-0018 HUMAN OTC DRUG Lip Smacker SPF Cherry Berry Ball OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0019_501e08e6-2970-46f8-ac50-e222f62855e8 50051-0019 HUMAN OTC DRUG Lip Smacker SPF 24 Lemon Lime Rush OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0020_61dbbea0-04f0-45b2-bd3f-d0c2c42f84c5 50051-0020 HUMAN OTC DRUG Lip Smacker SPF 24 Melon Extreme OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0021_d5acd24d-91d1-40fc-95ab-97defd7cc1f4 50051-0021 HUMAN OTC DRUG Lip Smacker SPF 24 Strawberry Scoop OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0022_5fbdd8bb-c47e-47cd-9655-7bf0204a1e53 50051-0022 HUMAN OTC DRUG Lip Smacker SPF 24 Kiwi Berry Crush OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0023_e3d9ee30-db14-44bb-8d40-2ab87bd8c270 50051-0023 HUMAN OTC DRUG Lip Smacker SPF 24 Power Punch OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50051-0024_40f33076-d0e2-4622-b204-47c222129bfb 50051-0024 HUMAN OTC DRUG Lip Smacker SPF 24 Watermelon Wave OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Bonne Bell LLC OCTINOXATE; OXYBENZONE; PADIMATE O 7.5; 6; 8 g/100g; g/100g; g/100g E 20171231 50061-001_eb5cb0fd-671e-4681-a7b2-796c3b850c4d 50061-001 HUMAN OTC DRUG Command AntiBac Instant Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20091217 OTC MONOGRAPH NOT FINAL part333 FAZ Marketing ALCOHOL 62 mL/100mL E 20171231 50061-381_b8465814-67f7-4768-a309-5e785097e367 50061-381 HUMAN OTC DRUG Multi Symptom Cold Double Max Power dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 FAZ Marketing DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 50061-412_0427c703-52c8-44ee-a30c-75e79bb1c0a7 50061-412 HUMAN OTC DRUG Multi Symptom Cold CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part341 FAZ Marketing DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 50063-001_477f76fd-3b81-44d8-8299-3a9fe52808c5 50063-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070101 NDA NDA205767 Andy-Oxy Co., Inc. OXYGEN 995 mL/L N 20181231 50063-002_c49ba773-035b-46e3-816b-d5bbb86b5d5b 50063-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20130101 NDA NDA205766 Andy-Oxy Co., Inc. NITROGEN 992 mL/L N 20181231 50063-003_40e3a56e-cc6b-4f13-b36c-a905108423fa 50063-003 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20070101 UNAPPROVED MEDICAL GAS Andy-Oxy Co., Inc. AIR 1000 mL/L E 20171231 50063-004_60cca331-ce6e-13dc-e053-2a91aa0a09fa 50063-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20070101 NDA NDA205767 Andy-Oxy Co., Inc. OXYGEN 210 mL/L N 20181231 50066-001_79e8c9ea-fe91-474b-8392-67ae85c973c3 50066-001 HUMAN OTC DRUG Nikzon Hemorrhoidal PHENYLEPHRINE HYDROCHLORIDE and PRAMOXINE HYDROCHLORIDE CREAM TOPICAL 20131201 OTC MONOGRAPH FINAL part346 Genoma Lab USA Inc PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 2.5; 10 mg/g; mg/g N 20181231 50066-002_566a5a7d-38d2-484a-b71e-6f8edfd42247 50066-002 HUMAN OTC DRUG Cicatricure Ultra Moisturizing HYDROCORTISONE CREAM TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part348 Genoma Lab USA Inc HYDROCORTISONE 10 mg/g N 20181231 50066-013_d9f65879-a059-4fe1-afd7-1b119f735657 50066-013 HUMAN OTC DRUG Pomada De La Campana Triple Antibiotic Pain Relief Bacitracin, Neomycin sulfate, Polymyxin B sulfate, Pramoxine Hydrochloride CREAM TOPICAL 20140630 OTC MONOGRAPH FINAL part333B Genomma Lab USA, Inc. BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 50066-033_fefe7328-314b-4e80-b375-2aaeb8b04457 50066-033 HUMAN OTC DRUG Advanced Anti-Wrinkle Therapy Cicatricure Avobenxone 3.00 Octinoxate 7.50 Octisalate 5.00 Octocrylene 2.70 Oxybenzone 4.00 CREAM TOPICAL 20160609 OTC MONOGRAPH NOT FINAL part352 Genomma Lab AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 50066-034_b95e3203-b8e2-470c-957c-3d4f0d3fa17f 50066-034 HUMAN OTC DRUG Cicatricure Scar SPF 30 Avobenzone - 3% Octocrylene - 10% Oxybenzone - 6% CREAM TOPICAL 20170301 OTC MONOGRAPH FINAL part352 Genomma Lab AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 6 g/100mL; g/100mL; g/100mL N 20181231 50066-057_6613842a-e72d-4cd3-bc77-116df9161a99 50066-057 HUMAN OTC DRUG RAY DOL Pain Relieving Cream CREAM TOPICAL 20131215 OTC MONOGRAPH NOT FINAL part348 Genomma Lab USA Inc. MENTHOL; METHYL SALICYLATE 100; 150 mg/g; mg/g N 20181231 50066-065_f8d1488e-919d-496c-b1a6-e2090b6fe786 50066-065 HUMAN OTC DRUG Nasalub Nasal Relief Oxymetazoline HCL SPRAY NASAL 20141202 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 50066-070_01bc3409-9156-4400-8c5c-67e1f9d8ee3f 50066-070 HUMAN OTC DRUG Lagicam antifungal Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Genomma Lab USA, Inc. MICONAZOLE NITRATE 40 mg/g N 20181231 50066-080_1b71fc66-77ce-4d3c-ae78-358851dfb6b5 50066-080 HUMAN OTC DRUG Silka Antifungal Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Genomma Lab USA, Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 50066-161_671d14d7-d8b7-4999-94ac-727cb237b564 50066-161 HUMAN OTC DRUG DR BELLS POMADE Triple Antibiotic Plus Pain Relief OINTMENT TOPICAL 20120516 OTC MONOGRAPH FINAL part333B Genomma lab USA Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE 500; 10000; 3.5; 10 [USP'U]/g; [USP'U]/g; mg/g; mg/g N 20181231 50066-247_4792ae82-fa15-45ff-834f-f9231d272176 50066-247 HUMAN OTC DRUG Dalay Maximum Strength Diphenhydramine HCl 25 mg TABLET ORAL 20150421 OTC MONOGRAPH FINAL part338 Genomma Labs USA DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 50066-267_1ae15feb-bd13-4aec-afc7-ff77de8b0256 50066-267 HUMAN OTC DRUG Bi Electro Extra Strength Acetaminophen/Diphenhydramine HCl Caplets TABLET ORAL 20150427 OTC MONOGRAPH NOT FINAL part343 Genomma Lab USA ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 50066-285_28eaec3f-50eb-4e68-94e9-af971b16da0e 50066-285 HUMAN OTC DRUG Bi Electro Extra Strength Acetaminophen 250 mg /Aspirin 250 mg/Caffeine 65 mg TABLET ORAL 20150108 OTC MONOGRAPH NOT FINAL part343 Genomma Lab USA ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 E 20171231 50066-356_73930e63-c5a8-47d0-a6ac-017b8e5c322d 50066-356 HUMAN OTC DRUG Next Day Time Non drowsy Cold and Flue Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCI 5 mg CAPSULE, LIQUID FILLED ORAL 20150119 OTC MONOGRAPH FINAL part341 Genomma Lab USA ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 50066-357_574f4302-2db9-48b8-94f6-c0671fa38846 50066-357 HUMAN OTC DRUG Next Night Time Cold and Flu Relief Acetaminophen, Dextromethorphan, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20150121 OTC MONOGRAPH FINAL part341 Genomma Lab USA ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 E 20171231 50066-374_ab07e341-51a3-4d8d-b584-0719da994c1c 50066-374 HUMAN OTC DRUG Dragon Tabs Ibuprofen 200 mg TABLET ORAL 20150417 ANDA ANDA075010 Genomma Lab USA IBUPROFEN 200 mg/1 N 20181231 50066-400_592c1d1d-c6fa-7e93-e053-2a91aa0abb88 50066-400 HUMAN OTC DRUG Asepxia Acne Medication wipes Salicylic acid CLOTH TOPICAL 20150701 OTC MONOGRAPH FINAL part333D Genomma Labs SALICYLIC ACID 20 mg/mL N 20181231 50066-423_88f0cb1d-bda7-4951-a693-a3ce68171e44 50066-423 HUMAN OTC DRUG Nikzon Hemorrhoidal Phenylephrine Hydrochloride, and Pramoxine Hydrochloride CREAM TOPICAL 20150508 OTC MONOGRAPH FINAL part346 Genoma Lab USA Inc PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 2.5; 10 mg/g; mg/g N 20181231 50066-500_4ede6f4f-7b91-4e8b-ba6b-d9d0dcafeaeb 50066-500 HUMAN OTC DRUG Foot Silka Miconazole Nitrate POWDER TOPICAL 20160225 OTC MONOGRAPH FINAL part333C Genomma Lab MICONAZOLE NITRATE 2 g/100mL E 20171231 50066-501_60f59cac-fc05-4b6d-9a1c-6c511832f91b 50066-501 HUMAN OTC DRUG X Ray Pain Relieving Menthol - 10.00% Methyl Salicylate - 15.00% CREAM TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part348 Genomma Lab MENTHOL; METHYL SALICYLATE 10; 15 g/100mL; g/100mL N 20181231 50066-504_cf4d22ec-528d-4953-8a55-72ba90db4917 50066-504 HUMAN OTC DRUG Tukol Multi Symptom Cold DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120515 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 50066-516_70722c60-7e3a-430d-b694-18c0f619b737 50066-516 HUMAN OTC DRUG Tukol MAX ACTION Cold, Sore Throat and Cough ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCL LIQUID ORAL 20161216 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 50066-517_3a983e29-8847-40c9-b538-9b793eab9a15 50066-517 HUMAN OTC DRUG Tukol MAX ACTION Severe Congestion and Cough DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCL LIQUID ORAL 20161216 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 50066-519_2cb39d46-aba2-4f2c-a034-613db62a7380 50066-519 HUMAN OTC DRUG Childrens Tukol Multi-Symptom Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20160504 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL N 20181231 50066-525_abbc3017-0f3f-4c00-aa6f-c5786b17b423 50066-525 HUMAN OTC DRUG Childrens Tukol Acetaminophen Fever Reducer Pain Reducer ACETAMINOPHEN LIQUID ORAL 20160503 OTC MONOGRAPH NOT FINAL part343 Genomma Lab USA, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 50066-533_78c29875-153f-4c79-8fef-e1a23486e8fc 50066-533 HUMAN OTC DRUG Tukol X-Pecto Miel Multi Symptom Cold DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20130915 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 50066-536_158e568c-c1da-4e77-a6a4-34062f86f1fc 50066-536 HUMAN OTC DRUG Tukol A DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20140609 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 50066-540_62554b50-a5b2-47b8-999a-d135e286ecb3 50066-540 HUMAN OTC DRUG Next Night Severe Cold, Flu and Sore Throat ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20160602 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 50066-601_fa673d33-89b9-40b9-adc3-6c0c6ca420e8 50066-601 HUMAN OTC DRUG Tukol Maxium Strength Cough and Mucus Relief DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN CAPSULE, GELATIN COATED ORAL 20150317 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 N 20181231 50066-603_9ef494f6-e0a0-4b35-aecc-ab6f32eef10f 50066-603 HUMAN OTC DRUG NEXT COLD and FLU NIGHTTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE CAPSULE, GELATIN COATED ORAL 20160503 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 50066-604_8b1cb6dc-e098-4cd4-90a4-262f8b0f28bb 50066-604 HUMAN OTC DRUG NEXT COLD and FLU DAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, GELATIN COATED ORAL 20160503 OTC MONOGRAPH FINAL part341 Genomma Lab USA, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 50066-701_8f52d711-5aaa-470b-bbd1-d6724d85b3ca 50066-701 HUMAN OTC DRUG Cicatricure Avobenzone, Octinoxate, and Octocrylene CREAM TOPICAL 20171101 OTC MONOGRAPH FINAL part352 Genomma Lab USA AVOBENZONE; OCTINOXATE; OCTOCRYLENE 30; 75; 75 mg/mL; mg/mL; mg/mL N 20181231 50066-915_7b6700e4-3aeb-4446-a65c-88360feafbab 50066-915 HUMAN OTC DRUG Genozol Omeprazole TABLET, DELAYED RELEASE ORAL 20160729 NDA NDA022032 Genomma Lab USA, Inc. OMEPRAZOLE 20 mg/1 N 20181231 50066-916_e78ea36b-1e58-48c7-b6f3-7c102ecb0bc8 50066-916 HUMAN OTC DRUG TUKOL MAX ACTION COLD SORE THROAT AND COUGH Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20171115 OTC MONOGRAPH FINAL part341 Genomma Lab USA Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 50066-917_aaf1322a-d6b4-494c-912c-fd1fd708d614 50066-917 HUMAN OTC DRUG Tukol Max Action Severe Congestion and Cough Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20171115 OTC MONOGRAPH FINAL part341 Genomma Lab USA Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 50066-918_44ea11d2-7f7c-46b3-8658-e0cc73c3ba22 50066-918 HUMAN OTC DRUG Tukol Cough and Congestion Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL LIQUID ORAL 20171114 OTC MONOGRAPH FINAL part341 Genomma Lab USA Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 50078-101_6751ad6e-a9c1-4d10-a8ca-5cf089a81fc7 50078-101 HUMAN OTC DRUG Ed Hardy Habit Antiseptic Hand Sanitizing Wipe BENZALKONIUM CHLORIDE SWAB TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Ed Hardy Habit BENZALKONIUM CHLORIDE .12 1/1 N 20181231 50078-201_d34dd3f5-ad9a-4ce4-90b0-d8f3a3d6a0f0 50078-201 HUMAN OTC DRUG Ed Hardy Habit Antiseptic Hand Sanitizing Wipe BENZALKONIUM CHLORIDE SWAB TOPICAL 20091209 OTC MONOGRAPH NOT FINAL part333 Ed Hardy Habit BENZALKONIUM CHLORIDE .12 1/1 N 20181231 50090-0002_3805f386-c043-493e-89e3-cd31f4854781 50090-0002 HUMAN OTC DRUG Pharbest Regular Strength Aspirin Aspirin TABLET ORAL 20070112 OTC MONOGRAPH NOT FINAL part343 A-S Medication Solutions ASPIRIN 325 mg/1 N 20181231 50090-0003_50479dca-be02-4908-b26e-0438baba8f1c 50090-0003 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength TABLET ORAL 20110204 OTC MONOGRAPH NOT FINAL part343 A-S Medication Solutions ASPIRIN 325 mg/1 N 20181231 50090-0004_d1f3850e-99fd-4bdd-90bc-a73d144edf75 50090-0004 HUMAN OTC DRUG Pharbest Aspirin 325mg Aspirin TABLET, DELAYED RELEASE ORAL 20100920 OTC MONOGRAPH NOT FINAL part343 A-S Medication Solutions ASPIRIN 325 mg/1 N 20181231 50090-0005_d4402d4f-1061-407e-a7ea-64b8c7f20308 50090-0005 HUMAN OTC DRUG TYLENOL Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19840819 OTC MONOGRAPH NOT FINAL part343 A-S Medication Solutions ACETAMINOPHEN 500 mg/1 N 20181231 50090-0006_cf5c46fa-d6a7-49df-ad1d-6102e073b574 50090-0006 HUMAN PRESCRIPTION DRUG TYLENOL with Codeine acetaminophen and codeine phosphate TABLET ORAL 19770817 ANDA ANDA085055 A-S Medication Solutions ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 50090-0015_99257832-37cc-482a-a95d-db6f25580e65 50090-0015 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 A-S Medication Solutions SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 50090-0019_da7ed7ad-8595-43e5-b0e3-4b5fb66579d0 50090-0019 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 A-S Medication Solutions SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 50090-0022_b29535dc-ac33-473e-97ec-598f717153dd 50090-0022 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 A-S Medication Solutions DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 50090-0023_dfa9ac52-c494-4482-903d-d99ebc93ea09 50090-0023 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19860710 ANDA ANDA062677 A-S Medication Solutions DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 50090-0025_26c367d9-a237-45d2-9b84-b3be37b4ebf6 50090-0025 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET, FILM COATED ORAL 20110801 ANDA ANDA060359 A-S Medication Solutions ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50090-0026_839fac92-7e15-4b4b-90c8-16b4dff7f7f9 50090-0026 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19841107 ANDA ANDA062396 A-S Medication Solutions DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 50090-0029_f69f5bf2-858b-484b-9bb5-656a1a8f60f2 50090-0029 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 A-S Medication Solutions PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 50090-0030_9d1c5bd2-ca8e-40bc-ba6b-a551f6047167 50090-0030 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 A-S Medication Solutions AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50090-0031_9d1c5bd2-ca8e-40bc-ba6b-a551f6047167 50090-0031 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 A-S Medication Solutions AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50090-0034_72b9a3d9-9253-4833-88fd-1e49a7873e81 50090-0034 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19831021 ANDA ANDA088262 A-S Medication Solutions IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50090-0035_4886b22d-4c0b-4cd2-b9de-916cc5513414 50090-0035 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 ANDA ANDA081049 A-S Medication Solutions IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50090-0039_fe0aa825-19d1-4916-a1cc-a629d9b52295 50090-0039 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 A-S Medication Solutions DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 50090-0040_839dbfd9-3b28-451e-8ab9-792fab939072 50090-0040 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 A-S Medication Solutions DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 50090-0042_538ad9b7-f11b-495d-b7cc-afc39f3cf9fa 50090-0042 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20091116 ANDA ANDA078253 A-S Medication Solutions ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 50090-0045_f097c2d7-fd55-4191-b906-4ad6803c1704 50090-0045 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH NOT FINAL part348 A-S Medication Solutions DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50090-0046_ee73db53-d8e9-462c-a97c-5ddb32e267d4 50090-0046 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH NOT FINAL part348 A-S Medication Solutions DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50090-0050_4664aff2-7962-4f6e-a1d0-20597e89e4c1 50090-0050 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 A-S Medication Solutions INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0052_4664aff2-7962-4f6e-a1d0-20597e89e4c1 50090-0052 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 A-S Medication Solutions INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0055_625f6e1f-218c-4149-a828-a384539f11d6 50090-0055 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 A-S Medication Solutions INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0060_87aa80a2-7907-45b5-af4c-0f40b3125989 50090-0060 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 A-S Medication Solutions IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0066_87aa80a2-7907-45b5-af4c-0f40b3125989 50090-0066 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 A-S Medication Solutions IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0072_4dce682c-4324-4806-9e1a-5a426d32b689 50090-0072 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 A-S Medication Solutions CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50090-0073_7e0b4016-d569-4285-afe8-58bdf392156f 50090-0073 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 A-S Medication Solutions CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50090-0079_d90c4272-d62b-4e0e-9791-fce711b04b47 50090-0079 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 A-S Medication Solutions CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50090-0080_125a979d-50da-46fe-aa74-fc94874e596f 50090-0080 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 A-S Medication Solutions CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50090-0081_ef7683b3-7c15-4cc2-8faf-f4f1dbfae81e 50090-0081 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 A-S Medication Solutions CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50090-0086_2adbf54b-3222-44bf-91e5-3b1ddc3dc875 50090-0086 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20030701 NDA AUTHORIZED GENERIC NDA007073 A-S Medication Solutions SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 50090-0088_a7987f3f-425d-4be4-be84-8042451773d9 50090-0088 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 A-S Medication Solutions DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0089_1c4d9134-2467-474f-afcd-fef0b43d60a1 50090-0089 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 A-S Medication Solutions DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0092_2d91eb4a-e441-4b2a-a664-02fdf12b156e 50090-0092 HUMAN PRESCRIPTION DRUG Medrol methylprednisolone TABLET ORAL 19571024 NDA NDA011153 A-S Medication Solutions METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0095_a6b85aac-9f8d-4794-b76e-60e5fc8e6f39 50090-0095 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA080292 A-S Medication Solutions PREDNISONE 5 mg/1 N 20181231 50090-0096_83cdad70-b6ad-4d3f-9071-87cefe966c3f 50090-0096 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA080292 A-S Medication Solutions PREDNISONE 5 mg/1 N 20181231 50090-0097_c97bd55f-d4ce-4559-b12f-1b9b888850cb 50090-0097 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 A-S Medication Solutions PREDNISONE 10 mg/1 N 20181231 50090-0099_a6b85aac-9f8d-4794-b76e-60e5fc8e6f39 50090-0099 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 A-S Medication Solutions PREDNISONE 20 mg/1 N 20181231 50090-0100_83cdad70-b6ad-4d3f-9071-87cefe966c3f 50090-0100 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 A-S Medication Solutions PREDNISONE 20 mg/1 N 20181231 50090-0101_b5fbbe12-16cd-48c5-977b-7b7a2e79acc3 50090-0101 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 A-S Medication Solutions PREDNISONE 20 mg/1 N 20181231 50090-0102_1b4156af-d4ad-4b7f-acd4-afd74c8a6c5c 50090-0102 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030314 ANDA ANDA084283 A-S Medication Solutions PREDNISONE 50 mg/1 N 20181231 50090-0105_b202041b-4f8d-4ad7-a1cb-67e5b979f16f 50090-0105 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20100212 ANDA ANDA201451 A-S Medication Solutions MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 50090-0106_b202041b-4f8d-4ad7-a1cb-67e5b979f16f 50090-0106 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20100212 ANDA ANDA201451 A-S Medication Solutions MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 50090-0107_0b78c854-5c28-4e2e-b743-54d23255a292 50090-0107 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20100212 ANDA ANDA201451 A-S Medication Solutions MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 50090-0108_76e7782c-1a17-4df6-b1d2-261b5bda83d5 50090-0108 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 A-S Medication Solutions PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 50090-0109_41f7d7ae-ad0e-4180-9693-9e26955850ac 50090-0109 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 A-S Medication Solutions PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 50090-0111_ea3445d9-7654-4f13-984b-9c47c0dfefc7 50090-0111 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 19961118 ANDA ANDA040185 A-S Medication Solutions PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 50090-0120_38421709-eb17-4d08-9be3-f769a69632ec 50090-0120 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride ER Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111024 ANDA ANDA091680 A-S Medication Solutions DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50090-0121_366a82ea-2259-4e1c-94e6-87ec18cb6b40 50090-0121 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 19601117 NDA NDA012546 A-S Medication Solutions DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50090-0122_c15ea798-8d97-40a5-96c7-f41790d91048 50090-0122 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040786 A-S Medication Solutions HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 50090-0127_427c321f-1bae-41ce-aa11-944eda9e8c54 50090-0127 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 A-S Medication Solutions DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 50090-0129_d2234902-d085-42df-a65b-bd9af0484868 50090-0129 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 A-S Medication Solutions DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 50090-0130_3c0cc1ba-a21d-4636-b221-dd837d7c1cdc 50090-0130 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 A-S Medication Solutions DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 50090-0131_d3231415-94b8-4d55-ad3f-abf53dddaaaf 50090-0131 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride/Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20120608 UNAPPROVED DRUG OTHER A-S Medication Solutions CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] N 20181231 50090-0132_0ae0c220-34b8-4371-86bd-007299d67661 50090-0132 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 A-S Medication Solutions METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 50090-0133_8561b720-03ec-4ea0-9e12-e172e803fccb 50090-0133 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 A-S Medication Solutions NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50090-0135_da1aee4d-c5fc-45bd-a07a-4ce79ccbbb3e 50090-0135 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130617 ANDA ANDA202297 A-S Medication Solutions CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50090-0136_900d92c8-3ac0-492b-94bd-8632bc27e8e3 50090-0136 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 19860723 ANDA ANDA089424 A-S Medication Solutions SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 50090-0138_c21906b5-2db6-4e6c-99b5-3585baec7601 50090-0138 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 A-S Medication Solutions HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 50090-0139_2301ee4b-460f-4b3d-8806-19b3a02eace8 50090-0139 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 A-S Medication Solutions HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 50090-0140_c0cd6c90-f352-43cb-bd0d-7a40e61fc836 50090-0140 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20090702 ANDA ANDA040907 A-S Medication Solutions HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-0141_6b001daa-bc54-477d-9f7c-4447099766d8 50090-0141 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20090702 ANDA ANDA040907 A-S Medication Solutions HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-0143_bfca9229-46d2-41fc-8d24-1155a066cdd9 50090-0143 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070720 ANDA ANDA040780 A-S Medication Solutions HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-0147_482b54d9-3d6c-4367-8329-f45ed44151ac 50090-0147 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 A-S Medication Solutions PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-0148_7cee028f-fc82-423e-88db-3625002b4844 50090-0148 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070218 A-S Medication Solutions PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-0149_7cee028f-fc82-423e-88db-3625002b4844 50090-0149 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070219 A-S Medication Solutions PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-0150_eb31a367-334a-4aa4-a114-48e6cee9196d 50090-0150 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 A-S Medication Solutions FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50090-0152_eb31a367-334a-4aa4-a114-48e6cee9196d 50090-0152 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 A-S Medication Solutions FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50090-0154_eb31a367-334a-4aa4-a114-48e6cee9196d 50090-0154 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 A-S Medication Solutions FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50090-0156_04b810b5-854d-4f54-967a-448f8ac30b40 50090-0156 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20110107 ANDA ANDA071881 A-S Medication Solutions VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50090-0160_81c8cb15-3d4f-4561-a100-5ba6e06e0d3c 50090-0160 HUMAN OTC DRUG Tolnaftate TOLNAFTATE CREAM TOPICAL 20100211 OTC MONOGRAPH FINAL part333C A-S Medication Solutions TOLNAFTATE 10 mg/g N 20181231 50090-0161_ecc077c4-d280-486a-9366-d8bbed05a235 50090-0161 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20110802 OTC MONOGRAPH FINAL part333C A-S Medication Solutions TOLNAFTATE 1 g/100g N 20181231 50090-0162_35703d18-7143-4928-a2a9-a55c1ebc3a50 50090-0162 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 A-S Medication Solutions TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0163_b263caf6-669a-4364-aa6c-07f74ade2a2c 50090-0163 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT TOPICAL 19780214 ANDA ANDA085691 A-S Medication Solutions TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0165_add1563f-d3b7-4da2-9c7a-058cac7d70be 50090-0165 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate OINTMENT TOPICAL 19830831 NDA NDA018865 A-S Medication Solutions BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0166_21bf01d3-e7c0-48f9-8060-e4585ae3e754 50090-0166 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 A-S Medication Solutions MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 50090-0167_fb3f9607-9d04-430f-afee-c7c3739dd582 50090-0167 HUMAN PRESCRIPTION DRUG Premarin estrogens, conjugated TABLET, FILM COATED ORAL 20060101 NDA NDA004782 A-S Medication Solutions ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 50090-0169_21608110-756c-4a0a-8210-82760eaf105d 50090-0169 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 A-S Medication Solutions ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-0170_9e4322ea-f539-41c8-b3b4-90aee88b7502 50090-0170 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 A-S Medication Solutions METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-0171_032e832f-0c4c-4b7e-aa57-a0fdb8338d48 50090-0171 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 A-S Medication Solutions METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-0172_e4bd2091-7ab1-46a5-ad3a-d007079314cb 50090-0172 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 A-S Medication Solutions METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-0173_b9fa647a-f8ae-426f-ad8a-809a107ef040 50090-0173 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 A-S Medication Solutions METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-0174_af010477-03ff-40f3-ba95-9fb1bfcaa6bb 50090-0174 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 A-S Medication Solutions METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-0175_a16cb586-4796-4f23-b8eb-c83f8871093f 50090-0175 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 A-S Medication Solutions METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-0177_04976641-fe9a-4ab7-8819-b386c7f384a9 50090-0177 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 A-S Medication Solutions METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-0178_c7f8b6ff-8522-477a-ad80-c3deb560b3fc 50090-0178 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 A-S Medication Solutions METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-0185_47287ed7-c48b-4a13-8a81-0f04f75da831 50090-0185 HUMAN OTC DRUG Naphcon A naphazoline hydrochloride and pheniramine maleate SOLUTION/ DROPS OPHTHALMIC 19940608 NDA NDA020226 A-S Medication Solutions NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL N 20181231 50090-0189_78f9a562-dc70-4f9a-874d-8064f5cec740 50090-0189 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER A-S Medication Solutions THYROID, PORCINE 30 mg/1 N 20181231 50090-0190_0878bff1-6ca9-4548-9027-5b3485e662f0 50090-0190 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER A-S Medication Solutions THYROID, PORCINE 60 mg/1 N 20181231 50090-0193_e7f1bf9a-a200-4d24-95a5-a6342d0cd9d8 50090-0193 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 A-S Medication Solutions DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50090-0194_a1c93c1e-dffc-423f-8f56-cd70d42fb4c8 50090-0194 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 A-S Medication Solutions DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50090-0195_9b330527-abcb-4100-84e3-02faf1078770 50090-0195 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071307 A-S Medication Solutions DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50090-0199_387d017e-a159-4992-bc73-c6126b10e120 50090-0199 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100604 ANDA ANDA040756 A-S Medication Solutions FOLIC ACID 1 mg/1 N 20181231 50090-0200_e5a8b37d-f804-47d2-9dbd-73050b910d13 50090-0200 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20090601 ANDA ANDA040796 A-S Medication Solutions FOLIC ACID 1 mg/1 N 20181231 50090-0201_d1239c14-b179-4bdb-a037-67f88e792850 50090-0201 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 A-S Medication Solutions METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 50090-0211_e448c9bf-0a97-4d1a-86ba-fb48f3d94619 50090-0211 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 A-S Medication Solutions METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 50090-0212_1c813117-c214-46e8-8535-56d2c1d35971 50090-0212 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 A-S Medication Solutions METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 50090-0213_546c1abc-eed3-4dbb-abd5-ba3433bdfcaf 50090-0213 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 A-S Medication Solutions METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 50090-0217_670e53be-e033-42f4-952b-5ab47d473815 50090-0217 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20050628 ANDA ANDA065148 A-S Medication Solutions NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 50090-0218_90c5eef5-859e-4055-822e-5700802a03ad 50090-0218 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 A-S Medication Solutions CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50090-0219_ade37884-236a-4254-a267-580c069c283f 50090-0219 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 A-S Medication Solutions CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50090-0220_23a90928-56a9-4f39-a4d5-baca9dfc89e4 50090-0220 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 A-S Medication Solutions CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50090-0221_63fbb6ef-d00c-4446-b06e-7ab7bd5f0884 50090-0221 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 19981222 ANDA ANDA040183 A-S Medication Solutions METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0224_66f7b27e-99ca-416d-9c9f-3d1903e62065 50090-0224 HUMAN OTC DRUG Delsym Dextromethorphan SUSPENSION, EXTENDED RELEASE ORAL 20100504 NDA NDA018658 A-S Medication Solutions DEXTROMETHORPHAN 30 mg/5mL N 20181231 50090-0228_83b99432-49bb-4d30-97c2-7185d4d4e867 50090-0228 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 A-S Medication Solutions TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0230_468fdb63-04e8-402d-b450-a32159a037b3 50090-0230 HUMAN PRESCRIPTION DRUG SILVADENE silver sulfadiazine CREAM TOPICAL 19731126 NDA NDA017381 A-S Medication Solutions SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 50090-0233_3f539422-44d2-4396-bfb4-b7b13e9c35a4 50090-0233 HUMAN PRESCRIPTION DRUG Nystatin Nystatin OINTMENT TOPICAL 20060915 ANDA ANDA062472 A-S Medication Solutions NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 50090-0235_a8dca9b7-28c2-481b-ac22-f1aecb51ee15 50090-0235 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19840626 NDA NDA019137 A-S Medication Solutions BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0236_68cbfc13-b5ee-4982-bf57-4263f6d65983 50090-0236 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 19840904 NDA NDA019141 A-S Medication Solutions BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0237_98f3a144-efc8-4d3c-afba-babfad8e8a73 50090-0237 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate CREAM TOPICAL 19970901 ANDA ANDA070050 A-S Medication Solutions BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0244_e27cb061-02b2-48cd-baea-f775ff6393c9 50090-0244 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20060331 ANDA ANDA085025 A-S Medication Solutions HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0245_da7f6522-c055-44d1-af63-b6d51cda32c3 50090-0245 HUMAN PRESCRIPTION DRUG Nystatin nystatin CREAM TOPICAL 20060531 ANDA ANDA065315 A-S Medication Solutions NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 50090-0246_fba3bc28-6b36-4552-9b0e-c64b53b3e428 50090-0246 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 19941228 ANDA ANDA040066 A-S Medication Solutions SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 50090-0247_b8302d06-dcc6-46d8-9c08-ad903b69a3fe 50090-0247 HUMAN PRESCRIPTION DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN neomycin sulfate, polymyxin b sulfate and gramicidin SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064047 A-S Medication Solutions NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN 1.75; 10000; .025 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 50090-0248_9c3dba59-64fb-49ad-b208-1d2795255db2 50090-0248 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 A-S Medication Solutions ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50090-0252_a0d8e19b-e4c1-442e-96ea-2727d5f53c9e 50090-0252 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20111007 OTC MONOGRAPH FINAL part349 A-S Medication Solutions POLYVINYL ALCOHOL 14 mg/mL N 20181231 50090-0255_18f0fb30-72b7-403e-ba3e-2af5a075b9ae 50090-0255 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 A-S Medication Solutions LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 50090-0258_2ddce535-b17b-4938-aab3-ce4f7488550d 50090-0258 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20050712 ANDA ANDA088299 A-S Medication Solutions LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 50090-0261_1ec22815-b24d-44af-a130-ebe7d668c642 50090-0261 HUMAN PRESCRIPTION DRUG TUBERSOL Tuberculin Purified Protein Derivative INJECTION, SOLUTION INTRADERMAL 19560815 BLA BLA103941 A-S Medication Solutions TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU]/.1mL Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [Chemical/Ingredient] N 20181231 50090-0263_a1e202aa-d73f-46b3-816b-9f4623a618b8 50090-0263 HUMAN PRESCRIPTION DRUG INDOMETHACIN Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20090306 ANDA ANDA079175 A-S Medication Solutions INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0264_9d1c5bd2-ca8e-40bc-ba6b-a551f6047167 50090-0264 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 A-S Medication Solutions AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50090-0265_5f06c6c0-4a1b-45f3-a17a-6413e1c09cc8 50090-0265 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20050615 ANDA ANDA088327 A-S Medication Solutions LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 50090-0266_96e41c6d-c8bc-49b6-863b-2f6bb32484f2 50090-0266 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20110421 OTC MONOGRAPH NOT FINAL part343 A-S Medication Solutions ACETAMINOPHEN 325 mg/1 N 20181231 50090-0267_2247d401-c9dc-4f27-a2a9-40b4857618fd 50090-0267 HUMAN OTC DRUG Pharbetol Regular strength Acetaminophen TABLET ORAL 20070109 OTC MONOGRAPH NOT FINAL part343 A-S Medication Solutions ACETAMINOPHEN 325 mg/1 N 20181231 50090-0278_b87f3b0d-8aaa-4297-9d09-459085fcb083 50090-0278 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 A-S Medication Solutions DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50090-0279_b08268cc-cf9b-444d-b3bd-199663e79a96 50090-0279 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528 ANDA ANDA040195 A-S Medication Solutions ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 50090-0280_a0629db9-fc05-46d4-a75c-1cddb44a92b4 50090-0280 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 A-S Medication Solutions CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 50090-0281_9a8ae062-2aec-47e3-961d-74d1776a824b 50090-0281 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 A-S Medication Solutions CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 50090-0293_f54653bc-685d-482c-be7c-023d24ff42af 50090-0293 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 A-S Medication Solutions TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0294_3326e6bd-1923-4557-a392-85fc95d6603c 50090-0294 HUMAN PRESCRIPTION DRUG METHOTREXATE METHOTREXATE TABLET ORAL 19531207 NDA NDA008085 A-S Medication Solutions METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 50090-0295_ca388e48-60d8-440a-8a4e-626db0c0497f 50090-0295 HUMAN PRESCRIPTION DRUG KENALOG-10 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL 20090601 NDA NDA012041 A-S Medication Solutions TRIAMCINOLONE ACETONIDE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0298_dfa9ac52-c494-4482-903d-d99ebc93ea09 50090-0298 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19860710 ANDA ANDA062676 A-S Medication Solutions DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 50090-0299_63a97fb5-6dd0-488a-a060-3a78c907eb2a 50090-0299 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19860710 ANDA ANDA062676 A-S Medication Solutions DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 50090-0314_ca346d43-2745-4a9d-bf68-ae9bb69958dc 50090-0314 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 A-S Medication Solutions NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 50090-0315_4b605e1b-5c68-4a2d-938e-c73215edc363 50090-0315 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 A-S Medication Solutions CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-0316_1d834777-d60a-451b-9e33-1cbd26266562 50090-0316 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 A-S Medication Solutions CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-0317_668cabca-35a6-4b47-b356-c6b077a8c0b4 50090-0317 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20111107 ANDA ANDA074625 A-S Medication Solutions OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 50090-0324_5c89b148-571a-464e-8d13-e7b5592e4ce7 50090-0324 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 A-S Medication Solutions TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0325_e9c5aada-7aba-4f24-9049-71f3182b997a 50090-0325 HUMAN OTC DRUG Double Antibiotic Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B A-S Medication Solutions BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 50090-0326_366a82ea-2259-4e1c-94e6-87ec18cb6b40 50090-0326 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 19590806 NDA NDA011722 A-S Medication Solutions DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50090-0327_2c721bb9-0967-4a49-a139-cee566031b54 50090-0327 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TABLET ORAL 20101227 ANDA ANDA201212 A-S Medication Solutions DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50090-0332_04be70bd-587f-4e35-89e6-7b9a16d2fa43 50090-0332 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 A-S Medication Solutions NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50090-0333_9d1c5bd2-ca8e-40bc-ba6b-a551f6047167 50090-0333 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 A-S Medication Solutions AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50090-0338_3fce76fe-d5b2-4ff9-9b31-4947a1d3f0b9 50090-0338 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 A-S Medication Solutions PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 50090-0339_f30a2a64-bbcf-49b1-9af7-3415b6f5aa61 50090-0339 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 A-S Medication Solutions ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50090-0350_c9676da3-4784-4259-83c8-36cac3d325f6 50090-0350 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20060331 ANDA ANDA085025 A-S Medication Solutions HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0351_ef1e19ff-fb9e-4213-8d79-a1260dcd657b 50090-0351 HUMAN PRESCRIPTION DRUG acetic acid acetic acid SOLUTION AURICULAR (OTIC) 20100122 NDA NDA012179 A-S Medication Solutions ACETIC ACID 20.65 mg/mL N 20181231 50090-0352_270de939-e175-41d2-ab62-6409f586bc38 50090-0352 HUMAN OTC DRUG Humulin N Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 19830627 NDA NDA018781 A-S Medication Solutions INSULIN HUMAN 100 [iU]/mL N 20181231 50090-0353_7656db71-2f97-4364-8074-0643874ff9a8 50090-0353 HUMAN OTC DRUG Humulin R Insulin human INJECTION, SOLUTION PARENTERAL 19830627 NDA NDA018780 A-S Medication Solutions INSULIN HUMAN 100 [iU]/mL N 20181231 50090-0355_38b91d8e-82b5-4a42-954e-9a28a20c126d 50090-0355 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20140627 ANDA ANDA087479 A-S Medication Solutions HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 50090-0356_aa236fb9-1c97-4388-a272-936ad70c14a2 50090-0356 HUMAN PRESCRIPTION DRUG Multivitamin with fluoride .Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cyanocobalamin, Sodium Fluoride, Folic Acid, Niacin, Pyridoxine, Riboflavin, Thiamine, Vitamin A, and Vitamin D TABLET, CHEWABLE ORAL 20111220 UNAPPROVED DRUG OTHER A-S Medication Solutions .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE; FOLIC ACID; NIACIN; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A; VITAMIN D 15; 60; 4.5; 1; .3; 13.5; 1.05; 1.2; 1.05; 2500; 400 [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] N 20181231 50090-0357_df16dee8-7e8a-4236-8daf-bcf96f6ac0da 50090-0357 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20070122 OTC MONOGRAPH NOT FINAL part334 A-S Medication Solutions DOCUSATE SODIUM 100 mg/1 N 20181231 50090-0358_a641a1c6-adc8-4195-8d9e-450951d5e2d3 50090-0358 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 A-S Medication Solutions DOCUSATE SODIUM 100 mg/1 N 20181231 50090-0360_0cd97d90-420f-45ca-bdb5-b3e10f5cf56a 50090-0360 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20100108 OTC MONOGRAPH FINAL part333B A-S Medication Solutions BACITRACIN ZINC 500 [USP'U]/g N 20181231 50090-0361_3e299dd1-4808-4fe7-8080-33e1685a3188 50090-0361 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 A-S Medication Solutions ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50090-0362_e7ae783a-0d9c-445c-b74a-e684c38dff8d 50090-0362 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20060512 ANDA ANDA087356 A-S Medication Solutions TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0380_b2015e99-a71c-4d55-b56d-bc019de539df 50090-0380 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071745 A-S Medication Solutions PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50090-0417_08960965-7698-4a28-ae3d-271a6baadc4f 50090-0417 HUMAN PRESCRIPTION DRUG Myambutol Ethambutol hydrochloride TABLET, FILM COATED ORAL 20070810 NDA NDA016320 A-S Medication Solutions ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] N 20181231 50090-0427_bfbc31b2-832c-4884-8416-66de3cffcffb 50090-0427 HUMAN OTC DRUG Childrens Chewable Mapap Acetaminophen TABLET, CHEWABLE ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 A-S Medication Solutions ACETAMINOPHEN 80 mg/1 N 20181231 50090-0430_1684d789-4e35-485b-a7b8-f88d462b6813 50090-0430 HUMAN OTC DRUG Theragesic Creme METHYL SALICYLATE GEL TOPICAL 19810101 OTC MONOGRAPH NOT FINAL part348 A-S Medication Solutions METHYL SALICYLATE; MENTHOL 150; 10 mg/g; mg/g N 20181231 50090-0431_2a5bb8dd-880c-4963-9469-a7450c323772 50090-0431 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 A-S Medication Solutions HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 50090-0442_8382524f-cffe-4b70-aa98-be6b01b66df1 50090-0442 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 A-S Medication Solutions ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-0444_6576ec56-9574-47a0-a784-82cad20091b0 50090-0444 HUMAN OTC DRUG Humulin 70/30 Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 19890626 NDA NDA019717 A-S Medication Solutions INSULIN HUMAN 100 [iU]/mL N 20181231 50090-0447_71f22077-b18d-4d51-871c-e0c69f44fc3b 50090-0447 HUMAN PRESCRIPTION DRUG AK-POLY-BAC Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 20060508 ANDA ANDA064028 A-S Medication Solutions BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 50090-0448_f6199067-08d1-4de7-8d29-bcaa0070752a 50090-0448 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 A-S Medication Solutions ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-0455_6c6b0037-6273-4041-9f92-26eddcbe77e4 50090-0455 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 19930101 ANDA ANDA064013 A-S Medication Solutions AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 50090-0459_9d4bddff-3e49-4a58-8068-895f4f35657e 50090-0459 HUMAN PRESCRIPTION DRUG Depo-Provera medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA NDA020246 A-S Medication Solutions MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 50090-0468_a4272e18-598c-4375-9270-ae3022fc8ab4 50090-0468 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 A-S Medication Solutions NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0478_a4272e18-598c-4375-9270-ae3022fc8ab4 50090-0478 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 A-S Medication Solutions NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0480_922c3a3b-11c5-4657-9030-d8d1cc8b3e6f 50090-0480 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 A-S Medication Solutions NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0481_407c03e2-0e3d-4a03-885b-83441dab041f 50090-0481 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 A-S Medication Solutions NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0483_7a77f4a2-2282-4aef-b127-37ef76a80755 50090-0483 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 A-S Medication Solutions NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0485_202f6cb7-64dc-4e64-a6d8-886822756315 50090-0485 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20110815 ANDA ANDA070929 A-S Medication Solutions TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 50090-0489_0772bded-19e9-40fe-8562-28d07cdb19c0 50090-0489 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA074644 A-S Medication Solutions METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-0490_245eea0d-8801-4aa8-8602-f1c1bec64705 50090-0490 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 A-S Medication Solutions MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 50090-0491_1ac0e8a2-1e15-4e92-b503-4971109ccc3f 50090-0491 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961203 ANDA ANDA040159 A-S Medication Solutions MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 50090-0494_610dba3f-e06c-48b2-a678-2597b66a0e2a 50090-0494 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 A-S Medication Solutions GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50090-0497_41799e6f-cbc7-40a4-b7af-8b995057e8db 50090-0497 HUMAN OTC DRUG Novolin R Human Insulin INJECTION, SOLUTION SUBCUTANEOUS 19910625 NDA NDA019938 A-S Medication Solutions INSULIN HUMAN 100 [iU]/mL N 20181231 50090-0498_ddb78bda-b189-4b72-8426-26f40216135a 50090-0498 HUMAN OTC DRUG Novolin N Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 19910701 NDA NDA019959 A-S Medication Solutions INSULIN HUMAN 100 [iU]/mL N 20181231 50090-0500_208c4f4d-f080-4315-9b27-d2c4f827c1ca 50090-0500 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20040202 ANDA ANDA074151 A-S Medication Solutions CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50090-0503_53e92815-55a9-4580-985a-033a01911b75 50090-0503 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 A-S Medication Solutions GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50090-0505_62bd72ef-f4ad-4cf4-b61f-44faced4e2aa 50090-0505 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 A-S Medication Solutions GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50090-0507_257c1119-0291-4cca-998a-95a3b0feb670 50090-0507 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 A-S Medication Solutions NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50090-0509_07407986-40e8-4fbf-b15b-5be4f3ec7e15 50090-0509 HUMAN PRESCRIPTION DRUG Flurbiprofen Flurbiprofen TABLET, FILM COATED ORAL 19950602 ANDA ANDA074431 A-S Medication Solutions FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0510_afc009a6-3985-4b7c-b00c-edf6f799cc35 50090-0510 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 19960328 ANDA ANDA074461 A-S Medication Solutions INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 50090-0513_a36e63e7-b35c-43ac-a7ef-bce65c55305f 50090-0513 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride and Hydrochlorothiazide Amiloride Hydrochloride and Hydrochlorothiazide TABLET ORAL 19891201 ANDA ANDA071111 A-S Medication Solutions AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-0514_0355c798-f1a1-45c9-8b3e-44e7098060d2 50090-0514 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 A-S Medication Solutions ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-0517_c05ad3da-19fa-4c95-8111-1fac0f2875b6 50090-0517 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19980115 ANDA ANDA074543 A-S Medication Solutions ALBUTEROL SULFATE 5 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 50090-0520_cd272578-ca53-4624-aed7-99d3b184e175 50090-0520 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 19950401 ANDA ANDA081319 A-S Medication Solutions PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] N 20181231 50090-0521_4426d024-e0b0-42c4-80f9-2ca3de70ce57 50090-0521 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 19710603 ANDA ANDA080157 A-S Medication Solutions PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] N 20181231 50090-0522_e60a5b57-3f7b-4214-8a99-1cafdcaa2226 50090-0522 HUMAN PRESCRIPTION DRUG Triazolam triazolam TABLET ORAL 19821115 NDA AUTHORIZED GENERIC NDA017892 A-S Medication Solutions TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50090-0525_c7865043-7b79-463e-88f2-2146932439a0 50090-0525 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20100608 ANDA ANDA091348 A-S Medication Solutions SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 50090-0527_ab74815b-99d2-4bc9-b575-0c1cef7e4889 50090-0527 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20060613 ANDA ANDA085027 A-S Medication Solutions HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0529_4162ed59-036f-48c4-8929-e2e3388a0359 50090-0529 HUMAN PRESCRIPTION DRUG SULINDAC SULINDAC TABLET ORAL 20100125 ANDA ANDA072711 A-S Medication Solutions SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0530_46cf103a-471f-4272-982c-42ebe0dfb23e 50090-0530 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19850418 UNAPPROVED DRUG OTHER A-S Medication Solutions SODIUM BICARBONATE 84 mg/mL N 20181231 50090-0532_bf076a98-29b8-4ba0-b3a6-13d114f35b61 50090-0532 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 A-S Medication Solutions BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 50090-0534_b4faa752-aec5-43e5-bbd5-779dc1806430 50090-0534 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 A-S Medication Solutions BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 50090-0539_959873b3-ff09-4418-a222-89f22baa1f98 50090-0539 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 A-S Medication Solutions DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0542_ac9f9ba1-aa5a-4e59-baaa-e99f8e9f2590 50090-0542 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 A-S Medication Solutions DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0543_d5b84221-d687-459e-b422-370392e1eb6a 50090-0543 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 A-S Medication Solutions DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0550_919f0d67-a0da-4ad8-a12a-e0c0922cd4be 50090-0550 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20101004 NDA NDA020564 A-S Medication Solutions LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 50090-0552_94e2ad17-95bf-4125-b9a6-5cb35f9176ca 50090-0552 HUMAN OTC DRUG Adult Low Dose Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20070112 OTC MONOGRAPH NOT FINAL part343 A-S Medication Solutions ASPIRIN 81 mg/1 N 20181231 50090-0556_7701faf2-704b-41eb-9c75-809090fbae7b 50090-0556 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 A-S Medication Solutions METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0559_f6fd2a7b-0af2-47fe-bfda-e9a2b2f1db94 50090-0559 HUMAN PRESCRIPTION DRUG Prednisolone Acetate Prednisolone Acetate SUSPENSION/ DROPS OPHTHALMIC 19941215 NDA AUTHORIZED GENERIC NDA017469 A-S Medication Solutions PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0561_a4467432-2f2b-4ec4-b6a2-f3ea70292a88 50090-0561 HUMAN PRESCRIPTION DRUG Prednisolone Acetate Prednisolone Acetate SUSPENSION/ DROPS OPHTHALMIC 19941215 NDA AUTHORIZED GENERIC NDA017469 A-S Medication Solutions PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0562_8b56e60a-ddde-424f-8f4b-54c14d803964 50090-0562 HUMAN OTC DRUG clotrimazole Clotrimazole CREAM TOPICAL 20110603 OTC MONOGRAPH FINAL part333C A-S Medication Solutions CLOTRIMAZOLE 1 g/100g N 20181231 50090-0568_2663b158-a395-476c-81d4-381e14394d90 50090-0568 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20061213 ANDA ANDA064163 A-S Medication Solutions GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 50090-0569_379e0b7f-c090-472b-b8be-c9bf71dd33b0 50090-0569 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 19940511 ANDA ANDA064048 A-S Medication Solutions GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 50090-0570_e58fe8ca-380d-4c90-86a7-be4e9601a0af 50090-0570 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 A-S Medication Solutions NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0571_4ec67f4e-7f93-41fa-a3d1-2b6d74df63f9 50090-0571 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin, Polymyxin B Sulfates, Dexamethasone OINTMENT OPHTHALMIC 20140703 ANDA ANDA062938 A-S Medication Solutions DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 50090-0572_4a74e125-6b78-46ea-982b-37b21cbe502c 50090-0572 HUMAN PRESCRIPTION DRUG Tetracaine Hydrochloride Tetracaine Hydrochloride SOLUTION OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER A-S Medication Solutions TETRACAINE HYDROCHLORIDE 5 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 50090-0579_b2772999-e2ec-418d-85d2-9e73be6d1ac7 50090-0579 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20060207 ANDA ANDA065311 A-S Medication Solutions CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50090-0582_f7e0c0ba-d705-48b6-a204-74f7adcf4cea 50090-0582 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961111 ANDA ANDA070848 A-S Medication Solutions SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 50090-0584_63759830-8765-4a88-aa57-264adfc0f363 50090-0584 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 A-S Medication Solutions VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50090-0591_18f2bfde-8ec9-4e3d-9170-771cfa2bd0cb 50090-0591 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 A-S Medication Solutions ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0593_632bae16-5ed9-493c-84eb-26ce6c7990f3 50090-0593 HUMAN PRESCRIPTION DRUG Patanol olopatadine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19970217 NDA NDA020688 A-S Medication Solutions OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 50090-0595_47e8bac6-4db4-4c32-8ed1-ba92ebf6d90b 50090-0595 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20060320 ANDA ANDA075677 A-S Medication Solutions ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50090-0596_f7e90b10-555d-4167-b030-3f0a06c6c95c 50090-0596 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20091022 ANDA ANDA075090 A-S Medication Solutions ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50090-0601_a6751be4-4f5a-442e-82b7-57053a961f58 50090-0601 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 A-S Medication Solutions KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 50090-0603_c1f2370f-8885-46e8-8130-6ad81ced0747 50090-0603 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate TABLET, FILM COATED ORAL 19960718 NDA NDA050711 A-S Medication Solutions AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50090-0604_6c2e077d-fee8-43ed-b1eb-514d08c1e3ae 50090-0604 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 A-S Medication Solutions RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50090-0605_376f8698-da9a-44e1-bd79-6c8f045c2473 50090-0605 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 A-S Medication Solutions RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50090-0606_56044c34-fb0e-43ea-a1be-918addd0fa4c 50090-0606 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 A-S Medication Solutions RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50090-0607_ad82e00a-983e-469c-a938-3a34d10fdd88 50090-0607 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 A-S Medication Solutions SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 50090-0611_64bd965c-0594-4463-80a6-33cf21eddbc2 50090-0611 HUMAN OTC DRUG FERROUS SULFATE IRON SUPPLEMENT TABLET ORAL 20010219 UNAPPROVED DRUG OTHER A-S Medication Solutions FERROUS SULFATE 325 mg/1 N 20181231 50090-0617_26dd0268-08b8-445b-a631-cf5fa1bd7eb5 50090-0617 HUMAN PRESCRIPTION DRUG PNV Prenatal Plus Multivitamin VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, and CUPRIC OXIDE TABLET ORAL 20130401 UNAPPROVED DRUG OTHER A-S Medication Solutions VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE 2000; 2000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 50090-0622_ba0ed39a-2f34-4892-b32a-2f221f96191f 50090-0622 HUMAN OTC DRUG Aprodine Pseudoephedrine HCl and Tripolidine TABLET, FILM COATED ORAL 19930109 OTC MONOGRAPH FINAL part341 A-S Medication Solutions PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 60; 2.5 mg/1; mg/1 N 20181231 50090-0624_215b2f9b-1f81-4433-9cef-97c339ad6c2c 50090-0624 HUMAN PRESCRIPTION DRUG Proventil HFA Albuterol Sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20011001 NDA NDA020503 A-S Medication Solutions ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 50090-0625_cd6861b6-11ce-4821-9f6a-c22a55042037 50090-0625 HUMAN PRESCRIPTION DRUG Flurbiprofen Sodium Flurbiprofen Sodium SOLUTION/ DROPS OPHTHALMIC 19950104 ANDA ANDA074447 A-S Medication Solutions FLURBIPROFEN SODIUM .3 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0632_09e4ae16-0361-4993-b903-dd95de78da03 50090-0632 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19920201 ANDA ANDA063181 A-S Medication Solutions MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 50090-0633_ae1f9917-152a-4fbd-8409-6921b416b826 50090-0633 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 A-S Medication Solutions MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 50090-0635_5b06439f-84a8-47a0-ab3b-ca4863a419cc 50090-0635 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA063065 A-S Medication Solutions MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 50090-0638_f9655a55-b873-4e01-b4d5-07bcbf12226e 50090-0638 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 A-S Medication Solutions ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50090-0644_74661dc7-9e98-44df-a0f2-f04292b8653f 50090-0644 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 A-S Medication Solutions ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50090-0645_0d4b7763-5a82-424f-b54b-5f526db55ce8 50090-0645 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 A-S Medication Solutions ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50090-0646_8dffa5ef-6334-4ce1-ba31-81f9575bf19d 50090-0646 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19980811 ANDA ANDA075219 A-S Medication Solutions DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0647_9fd8f9b7-4bd3-448c-ab20-71bc8dab440f 50090-0647 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19981120 ANDA ANDA075229 A-S Medication Solutions DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0650_c857dcdf-3c9b-4382-82d3-adc74bc4df2c 50090-0650 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 A-S Medication Solutions TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0651_16134051-f28f-4612-a565-987755a9b4c8 50090-0651 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 19980420 NDA AUTHORIZED GENERIC NDA020404 A-S Medication Solutions TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 50090-0659_930f1134-176a-4913-b24a-c072a794ff23 50090-0659 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 19980330 ANDA ANDA074823 A-S Medication Solutions TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 50090-0662_d5b50c96-3232-4f7e-b4e6-c05682070f6b 50090-0662 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 19991027 NDA NDA021087 A-S Medication Solutions OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 50090-0665_704c099c-3a96-4bc2-bf20-363e841c719e 50090-0665 HUMAN PRESCRIPTION DRUG Depo-Provera medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA NDA020246 A-S Medication Solutions MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 50090-0668_97f9ee82-19ce-47ad-a8af-8075aff576a8 50090-0668 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110201 ANDA ANDA075693 A-S Medication Solutions IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 50090-0670_b6b00aea-2d30-49f6-bf0d-f1e86b7b7f2d 50090-0670 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 A-S Medication Solutions DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 50090-0671_aa61242f-3516-4d62-97f7-4476724372c0 50090-0671 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 A-S Medication Solutions DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 50090-0672_24456cf1-26ae-484c-a562-2f2b15459096 50090-0672 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 A-S Medication Solutions DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 50090-0674_aa61242f-3516-4d62-97f7-4476724372c0 50090-0674 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 A-S Medication Solutions DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 50090-0678_302eff16-52ef-46ab-9e37-72bbb170579d 50090-0678 HUMAN PRESCRIPTION DRUG Clomiphene Citrate Clomiphene Citrate TABLET ORAL 19990830 ANDA ANDA075528 A-S Medication Solutions CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 50090-0679_c28230dd-9040-427b-a8f5-71ea5df1ebe4 50090-0679 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20010726 ANDA ANDA075993 A-S Medication Solutions LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 50090-0681_2a3424e0-0db4-4a29-918c-f129d9d08732 50090-0681 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 A-S Medication Solutions HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 50090-0683_e95ad769-208b-4a8b-b952-8e446e341367 50090-0683 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 A-S Medication Solutions MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50090-0685_587e4dc9-6489-4daf-95e8-e914830cc87c 50090-0685 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140411 ANDA ANDA074661 A-S Medication Solutions NAPROXEN SODIUM 220 mg/1 N 20181231 50090-0687_d2bb8dfd-2302-42ba-a3b9-e33aaa489714 50090-0687 HUMAN PRESCRIPTION DRUG MALARONE atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20000726 NDA NDA021078 A-S Medication Solutions ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 50090-0689_3ac8abd3-2b54-4e50-b970-c10f8c62e7a1 50090-0689 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 A-S Medication Solutions ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50090-0690_3ac8abd3-2b54-4e50-b970-c10f8c62e7a1 50090-0690 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 A-S Medication Solutions ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50090-0692_3ac8abd3-2b54-4e50-b970-c10f8c62e7a1 50090-0692 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 A-S Medication Solutions ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50090-0695_57c99a1a-7ccb-4df5-88ca-11959877a737 50090-0695 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130611 NDA AUTHORIZED GENERIC NDA020198 A-S Medication Solutions NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50090-0697_57c99a1a-7ccb-4df5-88ca-11959877a737 50090-0697 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19930421 NDA AUTHORIZED GENERIC NDA020198 A-S Medication Solutions NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50090-0699_4c7f1cb6-f005-45dd-881b-729f5d9aa553 50090-0699 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100331 NDA AUTHORIZED GENERIC NDA019684 A-S Medication Solutions NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50090-0701_0520fe5d-5450-4e60-9e55-6b630abec4ae 50090-0701 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 A-S Medication Solutions DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50090-0704_0520fe5d-5450-4e60-9e55-6b630abec4ae 50090-0704 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 A-S Medication Solutions DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50090-0706_0520fe5d-5450-4e60-9e55-6b630abec4ae 50090-0706 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 A-S Medication Solutions DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50090-0709_1ab86027-dd3a-45b8-9b94-c2913d27590a 50090-0709 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 A-S Medication Solutions AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50090-0711_b3f317fd-10d3-49a2-bc6b-a5224609b03b 50090-0711 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 A-S Medication Solutions AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50090-0712_d21fb950-919d-4d68-a6f3-8d8f499b3fc3 50090-0712 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 A-S Medication Solutions AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50090-0713_1ab86027-dd3a-45b8-9b94-c2913d27590a 50090-0713 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 A-S Medication Solutions AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50090-0714_94634c5c-f7e2-47b6-b039-9d31e15b2db7 50090-0714 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 A-S Medication Solutions AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50090-0717_7078038f-9a3a-4496-97a0-aaa531f8da52 50090-0717 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 A-S Medication Solutions SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 50090-0719_f0cddd6b-9c09-4626-93dd-d0aa3f1dc718 50090-0719 HUMAN PRESCRIPTION DRUG ketoconazole ketoconazole CREAM TOPICAL 20040428 ANDA ANDA076294 A-S Medication Solutions KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50090-0720_0428c295-38da-44f5-a601-ca03314b0dfa 50090-0720 HUMAN PRESCRIPTION DRUG ketoconazole ketoconazole CREAM TOPICAL 20040428 ANDA ANDA076294 A-S Medication Solutions KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50090-0724_18a76bf7-79ea-42e3-981b-5b6e47a480ce 50090-0724 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20100315 ANDA ANDA090510 A-S Medication Solutions HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-0729_70981a97-452b-4595-a77e-6519679c653f 50090-0729 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 A-S Medication Solutions HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50090-0730_94ebb336-3423-4116-bdcc-ffa72e4532a1 50090-0730 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010228 NDA NDA021077 A-S Medication Solutions SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 100 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0731_94ebb336-3423-4116-bdcc-ffa72e4532a1 50090-0731 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010205 NDA NDA021077 A-S Medication Solutions SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 250 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0732_94ebb336-3423-4116-bdcc-ffa72e4532a1 50090-0732 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20010305 NDA NDA021077 A-S Medication Solutions SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 500 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0734_0520fe5d-5450-4e60-9e55-6b630abec4ae 50090-0734 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 A-S Medication Solutions DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50090-0735_40aad14a-5dc4-4602-8f7a-58dfd47b4004 50090-0735 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20040610 ANDA ANDA076161 A-S Medication Solutions DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50090-0737_70c2d6e6-1146-43c9-961a-15ebd949577b 50090-0737 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020301 ANDA ANDA076008 A-S Medication Solutions BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 50090-0742_22d86308-38c8-4388-acb4-9b0f571e7b52 50090-0742 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 A-S Medication Solutions ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50090-0745_6aeb4db1-33cb-4b5d-80e4-1db015cc0c0c 50090-0745 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 A-S Medication Solutions FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-0746_4bfb0847-138c-48e6-b63e-e4d92036d019 50090-0746 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 19790725 ANDA ANDA085635 A-S Medication Solutions TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 50090-0749_6aeb4db1-33cb-4b5d-80e4-1db015cc0c0c 50090-0749 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 A-S Medication Solutions FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-0750_9a3f66c5-9ce1-4cbb-8ba1-7ad15d01a211 50090-0750 HUMAN PRESCRIPTION DRUG FLUOXETINE fluoxetine hydrochloride CAPSULE ORAL 20081014 ANDA ANDA076922 A-S Medication Solutions FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-0753_85a93d38-3584-4562-a98d-caa0d0cdf279 50090-0753 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 20020812 NDA NDA020487 A-S Medication Solutions VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50090-0754_ea07bdcf-3567-4ba9-9d30-e73b51394b8b 50090-0754 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED ORAL 20011026 NDA NDA021356 A-S Medication Solutions TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 50090-0759_3aec15c5-051a-40ed-b76b-3d77306e96ed 50090-0759 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 A-S Medication Solutions LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-0762_3aec15c5-051a-40ed-b76b-3d77306e96ed 50090-0762 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 A-S Medication Solutions LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-0763_d7d1029f-bf7d-4887-ae46-f33937d91a23 50090-0763 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 A-S Medication Solutions SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 50090-0766_e84c7ade-5b1c-4ee0-9944-5f9debe0caec 50090-0766 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 A-S Medication Solutions METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50090-0768_9375bbcc-8228-41b1-9f3e-7705772c0bc5 50090-0768 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate GEL TOPICAL 20000128 ANDA ANDA064160 A-S Medication Solutions CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 50090-0771_3a592046-786e-45e8-a050-103929efab94 50090-0771 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20020129 ANDA ANDA075967 A-S Medication Solutions METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50090-0775_e84c7ade-5b1c-4ee0-9944-5f9debe0caec 50090-0775 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 A-S Medication Solutions METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50090-0785_d67c4dfc-6b05-4eb7-a740-2b76b8899973 50090-0785 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 A-S Medication Solutions BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50090-0787_687bcb34-71fe-46b9-8f77-3c22f43878e8 50090-0787 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 A-S Medication Solutions ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50090-0789_8f4f7795-ef13-433c-b36f-9a03500d6f6c 50090-0789 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 A-S Medication Solutions HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE 6.25; 5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-0794_de02d4ab-6ddb-4889-854d-509055a856fa 50090-0794 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 A-S Medication Solutions POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 50090-0796_8f4f7795-ef13-433c-b36f-9a03500d6f6c 50090-0796 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 A-S Medication Solutions HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE 6.25; 2.5 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-0798_0e5553e2-87eb-4175-bc04-3b9a2d34e71f 50090-0798 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20030725 ANDA ANDA065135 A-S Medication Solutions CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50090-0799_8f4f7795-ef13-433c-b36f-9a03500d6f6c 50090-0799 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 A-S Medication Solutions HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE 6.25; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-0800_73dc086b-c1ab-420c-8dfd-33b65c14d802 50090-0800 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 A-S Medication Solutions NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-0802_092ba250-0e16-4b45-a464-03f434b6ae21 50090-0802 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 A-S Medication Solutions DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 50090-0809_9f9d0380-adb4-4abe-a51b-05ec545a3f40 50090-0809 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130213 ANDA ANDA076063 A-S Medication Solutions LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-0811_41e3bb73-706c-413b-b9a4-0503a2371e37 50090-0811 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 A-S Medication Solutions TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50090-0813_bb0ded28-c903-4377-9513-ad652aea8958 50090-0813 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 A-S Medication Solutions TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50090-0815_ee6b4b85-805e-4a1f-aa46-f4e99920f71a 50090-0815 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20110620 OTC MONOGRAPH FINAL part333B A-S Medication Solutions BACITRACIN 500 [USP'U]/g N 20181231 50090-0831_9aa371c0-dbd5-4a79-b2d9-5170f9e36676 50090-0831 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 A-S Medication Solutions AMOXICILLIN; CLAVULANIC ACID 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 50090-0832_9aa371c0-dbd5-4a79-b2d9-5170f9e36676 50090-0832 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 A-S Medication Solutions AMOXICILLIN; CLAVULANIC ACID 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 50090-0833_dbdc73a2-c144-4fd0-a4af-d821ff0617f6 50090-0833 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20021025 NDA NDA021445 A-S Medication Solutions EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 50090-0836_d33c7b72-281c-4148-969d-364f44e63841 50090-0836 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 A-S Medication Solutions LORATADINE 10 mg/1 N 20181231 50090-0837_ca8340a1-3a6a-42a3-8ef8-0c439f290571 50090-0837 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 A-S Medication Solutions LORATADINE 10 mg/1 N 20181231 50090-0838_3efd1beb-f277-4826-9c68-cc63ea59001e 50090-0838 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20050124 ANDA ANDA076471 A-S Medication Solutions LORATADINE 10 mg/1 N 20181231 50090-0840_41e3bb73-706c-413b-b9a4-0503a2371e37 50090-0840 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 A-S Medication Solutions TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50090-0841_bb0ded28-c903-4377-9513-ad652aea8958 50090-0841 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 A-S Medication Solutions TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50090-0846_87d69a2c-a722-4795-a007-2c33a0576c22 50090-0846 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 19950110 OTC MONOGRAPH FINAL part333B A-S Medication Solutions BACITRACIN 500 [USP'U]/g N 20181231 50090-0847_af08353d-302a-4c23-8e83-8ee466582b6e 50090-0847 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20110620 OTC MONOGRAPH FINAL part333B A-S Medication Solutions BACITRACIN 500 [USP'U]/g N 20181231 50090-0848_dd4a4f31-4318-4280-be28-775024541cfa 50090-0848 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 A-S Medication Solutions PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-0849_fe3117ad-ed0b-4660-b292-1937250c146c 50090-0849 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 A-S Medication Solutions PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-0858_7b71b2fc-28ce-46e5-9dc8-0b1c2bdd7e46 50090-0858 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 A-S Medication Solutions AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50090-0859_b2c311ba-019e-4bd1-867e-d965e78973bd 50090-0859 HUMAN PRESCRIPTION DRUG VIGAMOX moxifloxacin hydrochloride SOLUTION/ DROPS OPHTHALMIC 20030507 NDA NDA021598 A-S Medication Solutions MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50090-0861_e698cc2e-6e1b-494c-ac71-210cd37cfba8 50090-0861 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090324 ANDA ANDA079095 A-S Medication Solutions BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50090-0864_a538e1ac-d007-4ba5-9d91-4dc9dbe14ef3 50090-0864 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 A-S Medication Solutions CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50090-0865_27fc6fb8-6657-45cf-9113-910338291479 50090-0865 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 A-S Medication Solutions NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 50090-0867_e4da2d9a-26fb-4935-8540-60c57012306a 50090-0867 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 A-S Medication Solutions CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50090-0868_a538e1ac-d007-4ba5-9d91-4dc9dbe14ef3 50090-0868 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 A-S Medication Solutions CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50090-0869_98c9b33d-fdba-4e7e-84df-4a3bcfa64a21 50090-0869 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 A-S Medication Solutions FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 50090-0872_94482f28-0d48-49aa-98d6-bec3ab560693 50090-0872 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 A-S Medication Solutions BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 50090-0874_a0b0db6c-48a5-43ce-af4f-012465362c40 50090-0874 HUMAN PRESCRIPTION DRUG EPZICOM abacavir sulfate and lamivudine TABLET, FILM COATED ORAL 20101012 NDA NDA021652 A-S Medication Solutions ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 50090-0876_34096eb7-d16c-4dc8-ba6e-1399ffa00423 50090-0876 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20090923 NDA NDA021081 A-S Medication Solutions INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 50090-0883_bddfbdd3-3e8b-47ba-b483-8782a820b77f 50090-0883 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA AUTHORIZED GENERIC NDA020246 A-S Medication Solutions MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 50090-0890_6489d9fe-0912-48dc-af03-c77ed94d9adb 50090-0890 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 A-S Medication Solutions FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-0891_e39819ac-97bb-4167-a683-15ee8ee4db9c 50090-0891 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20080701 ANDA ANDA076407 A-S Medication Solutions OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50090-0892_1b43d5c8-def0-4cd9-b2cc-be2f3437f6a3 50090-0892 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 A-S Medication Solutions CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-0893_4e4a4440-c724-439b-9919-093b134393ad 50090-0893 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 A-S Medication Solutions CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-0895_350f325c-8704-4d7a-b709-bdaccc9442f2 50090-0895 HUMAN PRESCRIPTION DRUG gabapentin gabapentin CAPSULE ORAL 20060824 ANDA ANDA077242 A-S Medication Solutions GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50090-0898_03e58908-e585-4d0d-9611-3b958cb5d8d9 50090-0898 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20110608 ANDA ANDA090480 A-S Medication Solutions MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 50090-0909_d34b7638-1b89-423a-a498-ec4e1e8d793b 50090-0909 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20070822 OTC MONOGRAPH NOT FINAL part343 A-S Medication Solutions ASPIRIN 81 mg/1 N 20181231 50090-0910_c51ae8f3-7f4d-46c2-a96a-74d031390e89 50090-0910 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20070129 NDA NDA021433 A-S Medication Solutions FLUTICASONE PROPIONATE 110 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0912_31ee3c8c-04f0-4c00-a35f-eea09e32cf34 50090-0912 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 A-S Medication Solutions BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50090-0913_15815059-b591-46f2-a9bf-43e3027d6c3f 50090-0913 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 A-S Medication Solutions BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50090-0914_61615bd7-28b7-42e0-82e4-b6998de66069 50090-0914 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 A-S Medication Solutions BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50090-0916_15382109-c481-4f4b-a2ce-dbe8cb209693 50090-0916 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20070406 NDA NDA021433 A-S Medication Solutions FLUTICASONE PROPIONATE 44 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0917_e3b9c382-baef-42e7-95bc-8aec17b7f502 50090-0917 HUMAN PRESCRIPTION DRUG Terconazole Terconazole CREAM VAGINAL 20050119 ANDA ANDA076043 A-S Medication Solutions TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 50090-0921_8da2d290-c9b4-4c47-803d-521022a3a122 50090-0921 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 A-S Medication Solutions PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-0928_008c5fad-fe88-4222-967a-eedea6b9f673 50090-0928 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 A-S Medication Solutions AMOXICILLIN; CLAVULANIC ACID 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 50090-0934_d2b9e192-3dd5-4728-bd7e-16722ecf50a2 50090-0934 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20070125 NDA NDA021433 A-S Medication Solutions FLUTICASONE PROPIONATE 220 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0937_90f80b43-1360-4b7b-832a-cbd006cd3f19 50090-0937 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120120 ANDA ANDA078457 A-S Medication Solutions QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-0942_28799145-abe4-4c99-8213-93d616fa1381 50090-0942 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20110815 ANDA ANDA070929 A-S Medication Solutions TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 50090-0943_f1215b9a-a4be-408f-af20-bccc5de0c718 50090-0943 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 A-S Medication Solutions CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50090-0946_91ea395e-c503-4eea-b017-1d88f78e3ff7 50090-0946 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 A-S Medication Solutions LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-0948_fcf4fd48-7af5-45e1-a78a-0c58c70bd8c5 50090-0948 HUMAN PRESCRIPTION DRUG gabapentin gabapentin CAPSULE ORAL 20060824 ANDA ANDA077242 A-S Medication Solutions GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50090-0949_349a34bf-64ee-4b53-9426-ed5590288218 50090-0949 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 A-S Medication Solutions GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50090-0950_17afe9fc-41b0-4e2b-b099-cd70407583ba 50090-0950 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 A-S Medication Solutions FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 50090-0955_3821815d-058e-4ca5-b4bb-029295b7efa5 50090-0955 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20041004 ANDA ANDA076895 A-S Medication Solutions PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0958_b636b339-d0c3-46da-bca6-75bdc0ac4f96 50090-0958 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110718 ANDA ANDA065507 A-S Medication Solutions AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50090-0959_e18d5d7c-1cb9-400c-8d44-39fe76a444f1 50090-0959 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 A-S Medication Solutions AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50090-0963_2507f6d0-296e-4846-9dd9-6390715f62a4 50090-0963 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20080420 ANDA ANDA065390 A-S Medication Solutions RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 50090-0967_158c9d0d-0c3e-4b35-9d3b-fe9696d03962 50090-0967 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 A-S Medication Solutions CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 50090-0968_2e3f31bb-2ce5-437f-b52b-27ed448579ba 50090-0968 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20070919 ANDA ANDA077538 A-S Medication Solutions FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-0969_c626e4d7-55d1-46de-aca8-55147a99e297 50090-0969 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 A-S Medication Solutions CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-0972_65253537-e0b4-4720-98eb-83d1e4373f8b 50090-0972 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 A-S Medication Solutions SOLIFENACIN SUCCINATE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 50090-0975_1eff5754-725c-4b13-bf11-9859a221ea0d 50090-0975 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 A-S Medication Solutions PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-0980_17a747c1-84bd-4288-bfdd-192566d37a1b 50090-0980 HUMAN PRESCRIPTION DRUG Atripla efavirenz, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20060720 NDA NDA021937 A-S Medication Solutions EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600; 200; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 50090-0983_99163de8-f7be-406c-ab41-0ffce09fafe0 50090-0983 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101217 ANDA ANDA065246 A-S Medication Solutions AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50090-0984_63bbfbf1-807e-4a38-8d10-ae55f88d827e 50090-0984 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101217 ANDA ANDA065246 A-S Medication Solutions AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50090-0989_6a8dbf22-778c-47e5-84c1-95b940fbf176 50090-0989 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 A-S Medication Solutions SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-0991_3d5d69bc-fd62-4785-af1f-5ff61297cf9e 50090-0991 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 A-S Medication Solutions SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-0992_75808280-3a42-4424-816e-986730eaae16 50090-0992 HUMAN OTC DRUG Sudogest PE Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 A-S Medication Solutions PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 50090-0994_b2fef28b-13fc-46cf-8317-ed0d0d339fff 50090-0994 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin FOR SUSPENSION ORAL 20070904 ANDA ANDA065283 A-S Medication Solutions CLARITHROMYCIN 250 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50090-0999_caeebcfa-0cf2-4a9f-8555-ddd4c3a30bcb 50090-0999 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 A-S Medication Solutions SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-1000_fba215fa-ce70-47f0-8de2-9048169c2229 50090-1000 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 A-S Medication Solutions SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-1001_ed0b3665-4c17-4dc9-b85f-1d0722144942 50090-1001 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 A-S Medication Solutions PREDNISONE 10 mg/1 N 20181231 50090-1007_07a92e16-603b-4208-88e9-ed3399a3c3e6 50090-1007 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20030624 NDA NDA021567 A-S Medication Solutions ATAZANAVIR SULFATE 300 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 50090-1008_a17f7705-a20e-4a46-b5f6-16c4eddfa703 50090-1008 HUMAN PRESCRIPTION DRUG NUVARING etonogestrel and ethinyl estradiol INSERT, EXTENDED RELEASE VAGINAL 20011003 NDA NDA021187 A-S Medication Solutions ETONOGESTREL; ETHINYL ESTRADIOL .12; .015 mg/d; mg/d Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50090-1012_762c6951-54da-41d2-9345-00a74fbbc5a0 50090-1012 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL VAGINAL 20061031 ANDA ANDA077264 A-S Medication Solutions METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 50090-1015_ae8a53e2-4e44-4dff-a8e0-1da21dcf59fd 50090-1015 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 A-S Medication Solutions ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 50090-1016_ee6941d0-d560-44fe-b056-19a6cdfb061b 50090-1016 HUMAN PRESCRIPTION DRUG BICILLIN L-A penicillin G benzathine INJECTION, SUSPENSION INTRAMUSCULAR 19520627 NDA NDA050141 A-S Medication Solutions PENICILLIN G BENZATHINE 1200000 [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50090-1021_c1df8199-52c0-44a9-b166-3d6317a646f5 50090-1021 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 A-S Medication Solutions AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50090-1024_ac3f5ebc-4ae7-4899-9e33-3c6f0286bfc7 50090-1024 HUMAN PRESCRIPTION DRUG BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET ORAL 20100721 ANDA ANDA090968 A-S Medication Solutions BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 50090-1027_06a98c0d-6917-47d4-9a7e-4a0124c8c54c 50090-1027 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 A-S Medication Solutions CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50090-1042_04785d79-156a-44b9-8f36-62adf0d808cb 50090-1042 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 A-S Medication Solutions AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50090-1045_9ab53b3a-60ba-4883-83e9-6f9cdb1def09 50090-1045 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 A-S Medication Solutions FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50090-1057_d70b0d30-da05-4c1d-b438-156c9513352e 50090-1057 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 A-S Medication Solutions MIRTAZAPINE 30 mg/1 N 20181231 50090-1059_fcbc1339-e7f0-4527-8c5a-3c6fc6708c1b 50090-1059 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 A-S Medication Solutions BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50090-1064_34f70866-a826-4bcc-83c5-d2b739234a24 50090-1064 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 A-S Medication Solutions CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 50090-1069_34f70866-a826-4bcc-83c5-d2b739234a24 50090-1069 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 A-S Medication Solutions CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 50090-1075_c8716217-1af7-4a00-ab06-45333c8a2a0f 50090-1075 HUMAN OTC DRUG Mucinex D Guaifenesin and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120626 NDA NDA021585 A-S Medication Solutions GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 50090-1076_0436b531-6c52-4c21-ab85-d207f4c8514d 50090-1076 HUMAN OTC DRUG Mucinex D Guaifenesin and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120626 NDA NDA021585 A-S Medication Solutions GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 50090-1077_35bb89bc-369c-4b94-a7ab-6134859809b0 50090-1077 HUMAN OTC DRUG Mucinex DM Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20120626 NDA NDA021620 A-S Medication Solutions GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 600; 30 mg/1; mg/1 N 20181231 50090-1078_173f3868-3bc3-4a8f-aa39-36550d5bae2f 50090-1078 HUMAN OTC DRUG Mucinex DM Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20120626 NDA NDA021620 A-S Medication Solutions GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 600; 30 mg/1; mg/1 N 20181231 50090-1080_b2dc07ac-536b-4ba9-b752-2167e7a7196f 50090-1080 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 A-S Medication Solutions GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50090-1083_f549da52-6d7e-410c-b4f3-a4e732833dfc 50090-1083 HUMAN PRESCRIPTION DRUG Benicar HCT olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 A-S Medication Solutions OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-1085_afb2f47c-0a7c-428c-a2a6-526e2a6ead30 50090-1085 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20071012 NDA NDA022145 A-S Medication Solutions RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] N 20181231 50090-1086_67bc03e1-7c36-44a6-9772-41c8ee063cc6 50090-1086 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 A-S Medication Solutions AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50090-1088_e7e7d49c-5bd4-4ab3-acfb-589fe75a828f 50090-1088 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130418 ANDA ANDA202556 A-S Medication Solutions HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-1089_880a0b4e-286d-44f6-9d67-39c73f772b1e 50090-1089 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 A-S Medication Solutions CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 50090-1090_9fba8d5c-b5ec-4675-9267-ad5e44feddec 50090-1090 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20040514 ANDA ANDA076527 A-S Medication Solutions OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50090-1091_3a565ac8-ab1d-436e-82d3-d027604681aa 50090-1091 HUMAN PRESCRIPTION DRUG alendronate sodium alendronate sodium TABLET ORAL 20091023 ANDA ANDA076984 A-S Medication Solutions ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 50090-1097_70fb4dad-f26f-49a3-b110-47cebea154c2 50090-1097 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 A-S Medication Solutions ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-1098_5a85da77-ec08-44f3-a486-d253aa056e7f 50090-1098 HUMAN OTC DRUG Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080410 ANDA ANDA077170 A-S Medication Solutions CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 50090-1099_5849f7ca-c08b-4acb-b6b0-0f9792826dfc 50090-1099 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20071017 NDA NDA022122 A-S Medication Solutions DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-1101_89bb20a0-9a04-4800-b335-ced9b9401ea8 50090-1101 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071002 NDA NDA021777 A-S Medication Solutions CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50090-1106_1866e2e5-4d2b-42ea-ba0f-1ea13172df5a 50090-1106 HUMAN OTC DRUG Sudafed 12 Hour Pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080601 ANDA ANDA073585 A-S Medication Solutions PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 50090-1107_3afbf7c2-7ce1-4045-8ce7-f479cd35a239 50090-1107 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 A-S Medication Solutions LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-1112_d68a494d-99fe-4c46-aba7-5abe6b1f2ec2 50090-1112 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 A-S Medication Solutions FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-1118_a006588e-c60e-4673-8637-46957a75c357 50090-1118 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 A-S Medication Solutions RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-1121_fba215fa-ce70-47f0-8de2-9048169c2229 50090-1121 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 A-S Medication Solutions SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-1125_c275d26e-72a6-427e-9bd9-25bc06c19172 50090-1125 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 A-S Medication Solutions FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50090-1127_00ffcacf-9e81-4fc0-bec0-7066c1612c3d 50090-1127 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 A-S Medication Solutions NEBIVOLOL HYDROCHLORIDE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-1129_5ac97c50-63e1-4d3b-a70e-dd9770aa18df 50090-1129 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 A-S Medication Solutions SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 50090-1130_5ac97c50-63e1-4d3b-a70e-dd9770aa18df 50090-1130 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 A-S Medication Solutions SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 50090-1133_e6ea4d32-4635-4972-a7f2-ef5f2c1db8fe 50090-1133 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20091201 ANDA ANDA075442 A-S Medication Solutions FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 50090-1141_db3e93d9-c16b-44b4-99f1-f2bf4b6ff108 50090-1141 HUMAN OTC DRUG Plan B One-Step Levonorgestrel TABLET ORAL 20131218 NDA NDA021998 A-S Medication Solutions LEVONORGESTREL 1.5 mg/1 N 20181231 50090-1142_313a96eb-e27b-4a75-9ed7-116101a41aa7 50090-1142 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078434 A-S Medication Solutions KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 50090-1145_20201182-d7c5-4473-9d71-1b92f4b00fd7 50090-1145 HUMAN OTC DRUG Nicorelief Nicotine Polacrilex GUM, CHEWING ORAL 20050412 ANDA ANDA078325 A-S Medication Solutions NICOTINE 2 mg/1 N 20181231 50090-1150_bb93f53a-f573-417b-b71e-cd1025b1a754 50090-1150 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090611 ANDA ANDA079094 A-S Medication Solutions BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50090-1152_a619ca8b-b47c-4855-8ad8-f60a39f450e6 50090-1152 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex LOZENGE ORAL 20140331 ANDA ANDA077007 A-S Medication Solutions NICOTINE 2 mg/1 N 20181231 50090-1154_0b7a5138-1805-4198-a0a2-ba87d6d6536e 50090-1154 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex LOZENGE ORAL 20140331 ANDA ANDA077007 A-S Medication Solutions NICOTINE 4 mg/1 N 20181231 50090-1157_c668349a-7509-4db5-b0e3-d1ef2ffcbdb3 50090-1157 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 A-S Medication Solutions OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50090-1158_51996fd7-92d0-42fb-ad71-eb846475dab4 50090-1158 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 A-S Medication Solutions ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 50090-1159_b6f6b267-05a0-4f62-a70a-c4739731305e 50090-1159 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 A-S Medication Solutions ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 50090-1161_75d5cb53-eb4d-439e-b4b1-a6d32bf24f61 50090-1161 HUMAN PRESCRIPTION DRUG Labetalol HCL Labetalol Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA200908 A-S Medication Solutions LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-1162_54eb1678-e698-4ceb-bd90-b5d196d45ede 50090-1162 HUMAN PRESCRIPTION DRUG Norvir Ritonavir TABLET, FILM COATED ORAL 20100506 NDA NDA022417 A-S Medication Solutions RITONAVIR 100 mg/1 UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 50090-1176_8eadcf83-6eac-4ecc-b581-4844b709036d 50090-1176 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA090528 A-S Medication Solutions HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50090-1177_8eadcf83-6eac-4ecc-b581-4844b709036d 50090-1177 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA090528 A-S Medication Solutions HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50090-1182_6735cfdc-65ac-45fe-8804-b39286371f64 50090-1182 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20130531 ANDA ANDA203399 A-S Medication Solutions METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 50090-1185_592f0c76-9264-4c59-a7e0-9697c012eea9 50090-1185 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021106 ANDA ANDA076201 A-S Medication Solutions DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-1186_aef61a17-dd7d-4638-91a7-4e5b73bb7113 50090-1186 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 A-S Medication Solutions SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-1195_96609fc7-f430-461d-b1a5-2466a8e48140 50090-1195 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20080114 NDA NDA021234 A-S Medication Solutions DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-1196_c826a5c1-4779-410b-ab92-12ea43f95a7a 50090-1196 HUMAN PRESCRIPTION DRUG Terconazole Terconazole CREAM VAGINAL 20040406 ANDA ANDA075953 A-S Medication Solutions TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 50090-1200_937c3ca6-d99d-4646-a059-5975815a233b 50090-1200 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 A-S Medication Solutions ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 50090-1203_e4baae96-d8c1-4696-8603-df83a6244f13 50090-1203 HUMAN OTC DRUG Allegra-D Allergy and Congestion fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110303 NDA NDA020786 A-S Medication Solutions FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 N 20181231 50090-1210_8eadcf83-6eac-4ecc-b581-4844b709036d 50090-1210 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA090528 A-S Medication Solutions HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50090-1214_ecc3b48c-a9d1-4cbe-b036-ef2069f92fc8 50090-1214 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 A-S Medication Solutions VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-1216_ecc3b48c-a9d1-4cbe-b036-ef2069f92fc8 50090-1216 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 A-S Medication Solutions VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-1220_7d7e1138-6d96-4962-bb11-7aebdb94440e 50090-1220 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20100119 ANDA ANDA076419 A-S Medication Solutions KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50090-1223_9f6b2d06-8836-4ed8-8e66-776c370c7079 50090-1223 VACCINE ENGERIX-B Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR 20070328 BLA BLA103239 A-S Medication Solutions HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug/mL N 20181231 50090-1228_223b715c-83d1-4637-989d-46a7c668a8c8 50090-1228 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 A-S Medication Solutions LEVOFLOXACIN 750 mg/1 N 20181231 50090-1240_dc59eec6-cc4c-473c-a7a8-ee2c08f9e008 50090-1240 HUMAN PRESCRIPTION DRUG LATANOPROST LATANOPROST SOLUTION/ DROPS OPHTHALMIC 20120701 ANDA ANDA090887 A-S Medication Solutions LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 50090-1241_ca85a796-0d10-49fa-8ced-13152bcb7d66 50090-1241 HUMAN PRESCRIPTION DRUG Besivance Besifloxacin SUSPENSION OPHTHALMIC 20090528 NDA NDA022308 A-S Medication Solutions BESIFLOXACIN 6 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50090-1242_6bcc443e-9e43-4f9b-b941-95501b6bcd1e 50090-1242 HUMAN PRESCRIPTION DRUG RESTASIS cyclosporine EMULSION OPHTHALMIC 20030401 NDA NDA050790 A-S Medication Solutions CYCLOSPORINE .5 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50090-1244_c2b47596-9523-46f0-b948-d4c55c632b69 50090-1244 HUMAN PRESCRIPTION DRUG Tamiflu Oseltamivir Phosphate POWDER, FOR SUSPENSION ORAL 20130801 NDA NDA021246 A-S Medication Solutions OSELTAMIVIR PHOSPHATE 6 mg/mL N 20181231 50090-1246_8258673b-2434-414b-a63b-f1d55f9b7680 50090-1246 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride Dorzolamide Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20081028 ANDA ANDA077846 A-S Medication Solutions DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] N 20181231 50090-1247_32fe5529-d667-4ca2-a77d-f5dae3b6aee4 50090-1247 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20081028 ANDA ANDA077847 A-S Medication Solutions DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-1248_5b88be70-8056-442d-8fac-a374f029e06a 50090-1248 HUMAN PRESCRIPTION DRUG COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20110810 NDA NDA202123 A-S Medication Solutions EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE 200; 25; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [Chemical/Ingredient],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 50090-1250_ee935dc7-22f5-48a5-9fd9-792b8d1de27f 50090-1250 HUMAN PRESCRIPTION DRUG Tekturna aliskiren hemifumarate TABLET, FILM COATED ORAL 20070305 NDA NDA021985 A-S Medication Solutions ALISKIREN HEMIFUMARATE 300 mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA] N 20181231 50090-1269_7060813e-2937-4d30-a2bd-cadccde3bd41 50090-1269 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 A-S Medication Solutions LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50090-1270_320c2923-e8ab-4485-9668-ab12d9d1baef 50090-1270 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA073449 A-S Medication Solutions TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-1276_ce0f18da-6ca1-44d5-8368-4bc4be56c973 50090-1276 HUMAN PRESCRIPTION DRUG Levemir insulin detemir INJECTION, SOLUTION SUBCUTANEOUS 20060327 NDA NDA021536 A-S Medication Solutions INSULIN DETEMIR 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 50090-1277_caeebcfa-0cf2-4a9f-8555-ddd4c3a30bcb 50090-1277 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 A-S Medication Solutions SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-1278_045f2541-98b6-44c8-a597-e7478a27aa9f 50090-1278 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 A-S Medication Solutions TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 50090-1284_dc7fa505-bd6e-4dd8-a142-c3cdc8068e1e 50090-1284 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202910 A-S Medication Solutions IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50090-1285_944c3593-1d3e-421e-b12f-fccd86195608 50090-1285 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 A-S Medication Solutions DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 50090-1286_944c3593-1d3e-421e-b12f-fccd86195608 50090-1286 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 A-S Medication Solutions DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 50090-1290_75d5cb53-eb4d-439e-b4b1-a6d32bf24f61 50090-1290 HUMAN PRESCRIPTION DRUG Labetalol HCL Labetalol Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA200908 A-S Medication Solutions LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-1291_75d5cb53-eb4d-439e-b4b1-a6d32bf24f61 50090-1291 HUMAN PRESCRIPTION DRUG Labetalol HCL Labetalol Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA200908 A-S Medication Solutions LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-1296_fe3117ad-ed0b-4660-b292-1937250c146c 50090-1296 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 A-S Medication Solutions PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-1298_1b43d5c8-def0-4cd9-b2cc-be2f3437f6a3 50090-1298 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 A-S Medication Solutions CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-1299_6bb80cc3-5fdd-4863-acb9-f392d98d1c9b 50090-1299 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 A-S Medication Solutions SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 50090-1302_9f9f3fbc-cf4a-4e32-8769-31a8709a6495 50090-1302 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 A-S Medication Solutions ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 50090-1308_9fbbb0b1-7900-435a-a89b-2cad792048de 50090-1308 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 A-S Medication Solutions SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 50090-1316_d8755afb-5caa-4f61-b021-a718d13f1f8e 50090-1316 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 A-S Medication Solutions ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-1317_dc0f426e-5c71-4c8b-bb27-55866209a86a 50090-1317 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 A-S Medication Solutions ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-1318_b9f34088-ae70-4d4c-9bb0-5082745daeb4 50090-1318 HUMAN PRESCRIPTION DRUG Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20120827 NDA NDA203100 A-S Medication Solutions ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 150; 150; 200; 300 mg/1; mg/1; mg/1; mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 50090-1323_9dc43481-b807-4960-a319-a3e959458e4c 50090-1323 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 A-S Medication Solutions NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50090-1326_f08d05bd-517f-4a2f-983d-2b2df9cb5509 50090-1326 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110222 NDA AUTHORIZED GENERIC NDA018279 A-S Medication Solutions POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 50090-1327_a41f626a-2e4f-43d1-969a-5297cab4271c 50090-1327 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20121109 NDA NDA021976 A-S Medication Solutions DARUNAVIR ETHANOLATE 800 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 50090-1329_4831d61f-09d0-4127-91f7-9fa2327f3ec2 50090-1329 HUMAN PRESCRIPTION DRUG PROAIR HFA Albuterol Sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20121203 NDA NDA021457 A-S Medication Solutions ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 50090-1336_533195c2-6daa-4d7c-a4c0-929a16ff8d53 50090-1336 HUMAN PRESCRIPTION DRUG Aplisol Tuberculin Purified Protein Derivative INJECTION INTRADERMAL 20140425 BLA BLA103782 A-S Medication Solutions TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU]/.1mL Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [Chemical/Ingredient] N 20181231 50090-1337_7d66e1e4-a552-471d-a7af-550b7de263d1 50090-1337 HUMAN PRESCRIPTION DRUG Flumazenil flumazenil INJECTION, SOLUTION INTRAVENOUS 20070101 ANDA ANDA078527 A-S Medication Solutions FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 50090-1340_88acb57a-8c90-41a2-95a4-9b6e04942ac9 50090-1340 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20120703 NDA NDA021282 A-S Medication Solutions GUAIFENESIN 600 mg/1 N 20181231 50090-1342_c397a30d-eb13-48c3-aa6e-f3f9bf0d17a4 50090-1342 HUMAN PRESCRIPTION DRUG QVAR Beclomethasone Dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20140915 NDA NDA020911 A-S Medication Solutions BECLOMETHASONE DIPROPIONATE 80 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-1343_f96aad7c-781c-47f5-894e-32a31f6c934c 50090-1343 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 A-S Medication Solutions ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50090-1346_0b4ca118-6c8f-4e10-a906-933f0d659c0e 50090-1346 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20080701 ANDA ANDA076407 A-S Medication Solutions OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50090-1347_58615c0d-58f2-49de-84e1-85dfa0682ac6 50090-1347 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 A-S Medication Solutions AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50090-1354_b8827cf4-b6f2-42ca-bb10-7f8d96a28a78 50090-1354 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 A-S Medication Solutions RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-1360_8762adbc-29bb-47d0-b094-8dd0e4aa2a5e 50090-1360 HUMAN PRESCRIPTION DRUG epinephrine epinephrine INJECTION SUBCUTANEOUS 20100401 NDA AUTHORIZED GENERIC NDA020800 A-S Medication Solutions EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 50090-1362_1edee105-6dc9-45d8-b9d2-1288ff8429bf 50090-1362 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 A-S Medication Solutions PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-1363_6aff3eba-d47f-400d-a260-040e33f13c4b 50090-1363 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 A-S Medication Solutions FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 50090-1364_6511fbf9-2355-4a84-88ab-660e48b77550 50090-1364 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 A-S Medication Solutions FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 50090-1372_fcbc1339-e7f0-4527-8c5a-3c6fc6708c1b 50090-1372 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 A-S Medication Solutions BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50090-1375_6e954358-f583-4b19-a100-c20af304a16d 50090-1375 HUMAN PRESCRIPTION DRUG Humalog Insulin lispro INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19960614 NDA NDA020563 A-S Medication Solutions INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 50090-1377_45dd3085-f8e1-4eff-a22b-58a0c29ba569 50090-1377 VACCINE BOOSTRIX Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed SUSPENSION INTRAMUSCULAR 20090724 BLA BLA125106 A-S Medication Solutions CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 5; 2.5; 8; 8; 2.5 [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient] N 20181231 50090-1382_21244055-bad4-4ac8-8d1d-43ff14e59372 50090-1382 HUMAN PRESCRIPTION DRUG IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20121015 ANDA ANDA202496 A-S Medication Solutions ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 2.5; .5 mg/3mL; mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 50090-1383_ce321c8e-fe52-4434-87ac-320b5ce2f82c 50090-1383 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate clindamycin phosphate CREAM VAGINAL 20041227 ANDA ANDA065139 A-S Medication Solutions CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 50090-1386_971181a4-9336-4416-b656-41f2609c5fa6 50090-1386 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate OINTMENT TOPICAL 19960223 ANDA ANDA074407 A-S Medication Solutions CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-1388_1e043bf1-5768-4138-b05b-68f8d597bb88 50090-1388 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100710 ANDA ANDA078920 A-S Medication Solutions PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 50090-1392_c9552208-3213-4668-81b1-ec0e1397816a 50090-1392 HUMAN PRESCRIPTION DRUG MARLISSA Levonorgestrel and Ethinyl Estradiol KIT 20120229 ANDA ANDA091452 A-S Medication Solutions N 20181231 50090-1398_90fa3657-e9e7-4331-8dfa-3a9045b4d4bf 50090-1398 HUMAN PRESCRIPTION DRUG Lantus Solostar insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20090923 NDA NDA021081 A-S Medication Solutions INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 50090-1400_396f30cc-3873-48e4-8b93-f7867fc1a0ff 50090-1400 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 A-S Medication Solutions VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50090-1406_ecc3b48c-a9d1-4cbe-b036-ef2069f92fc8 50090-1406 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 A-S Medication Solutions VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-1411_a8847e53-e406-4b2e-a780-b76cb2e44859 50090-1411 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20030326 ANDA ANDA075183 A-S Medication Solutions PREDNISOLONE SODIUM PHOSPHATE 5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50090-1412_d6452326-6693-4edc-b788-3c2552b631f7 50090-1412 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 A-S Medication Solutions VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-1420_d6452326-6693-4edc-b788-3c2552b631f7 50090-1420 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 A-S Medication Solutions VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-1422_d6452326-6693-4edc-b788-3c2552b631f7 50090-1422 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 A-S Medication Solutions VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-1432_9ab53b3a-60ba-4883-83e9-6f9cdb1def09 50090-1432 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 A-S Medication Solutions FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50090-1434_1edee105-6dc9-45d8-b9d2-1288ff8429bf 50090-1434 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 A-S Medication Solutions PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-1436_672261fb-0951-4e91-9bd5-07621ef4766f 50090-1436 HUMAN PRESCRIPTION DRUG ELIQUIS apixaban TABLET, FILM COATED ORAL 20121228 NDA NDA202155 A-S Medication Solutions APIXABAN 2.5 mg/1 Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 50090-1437_672261fb-0951-4e91-9bd5-07621ef4766f 50090-1437 HUMAN PRESCRIPTION DRUG ELIQUIS apixaban TABLET, FILM COATED ORAL 20121228 NDA NDA202155 A-S Medication Solutions APIXABAN 5 mg/1 Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 50090-1444_54e3cc07-cb2d-44a5-a0b8-f5c110b58048 50090-1444 HUMAN OTC DRUG Nasacort Allergy 24HR Triamcinolone Acetonide SPRAY, METERED NASAL 20140203 NDA NDA020468 A-S Medication Solutions TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 50090-1451_1e043bf1-5768-4138-b05b-68f8d597bb88 50090-1451 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100710 ANDA ANDA078920 A-S Medication Solutions PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 50090-1454_c404a768-a5c0-423f-a40f-b722867de610 50090-1454 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20101124 ANDA ANDA077421 A-S Medication Solutions LORATADINE 5 mg/5mL N 20181231 50090-1460_b28de4fd-c88e-408b-b59c-413a624e2b9f 50090-1460 HUMAN OTC DRUG Nexium 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20140527 NDA NDA204655 A-S Medication Solutions ESOMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 50090-1462_e2e926d7-b3db-4ffe-85b3-2cbb72807054 50090-1462 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20120501 ANDA ANDA091605 A-S Medication Solutions DOXYCYCLINE 100 mg/1 N 20181231 50090-1470_40d12955-6c2d-4ba5-ba7e-9920e7b938ec 50090-1470 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101227 ANDA ANDA091544 A-S Medication Solutions LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 50090-1472_a8b584b2-a435-4fa5-b785-2159aa8840cf 50090-1472 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20001201 ANDA ANDA065055 A-S Medication Solutions DOXYCYCLINE 100 mg/1 N 20181231 50090-1475_ce0f18da-6ca1-44d5-8368-4bc4be56c973 50090-1475 HUMAN PRESCRIPTION DRUG Levemir insulin detemir INJECTION, SOLUTION SUBCUTANEOUS 20131031 NDA NDA021536 A-S Medication Solutions INSULIN DETEMIR 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 50090-1484_4762c39d-c0c4-4346-b7f6-edc5c778add1 50090-1484 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 A-S Medication Solutions ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50090-1485_ca40d09e-75c5-467e-8538-f9f9fa24d3cd 50090-1485 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 A-S Medication Solutions BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 50090-1486_074b036c-dfce-4827-9586-2d67f95891b2 50090-1486 HUMAN PRESCRIPTION DRUG SELZENTRY maraviroc TABLET, FILM COATED ORAL 20110516 NDA NDA022128 A-S Medication Solutions MARAVIROC 300 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] N 20181231 50090-1491_a41f626a-2e4f-43d1-969a-5297cab4271c 50090-1491 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20080308 NDA NDA021976 A-S Medication Solutions DARUNAVIR ETHANOLATE 600 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 50090-1493_8649c2e8-0ef0-4dda-bbf8-b2feed9cb065 50090-1493 VACCINE Typhim Vi SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN INJECTION, SOLUTION INTRAMUSCULAR 19941128 BLA BLA103936 A-S Medication Solutions SALMONELLA TYPHI TY2 VI POLYSACCHARIDE ANTIGEN 25 ug/.5mL Inactivated Salmonella Typhi Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Vaccines, Typhoid [Chemical/Ingredient],Vi polysaccharide vaccine, typhoid [Chemical/Ingredient] N 20181231 50090-1498_d8b81a4e-dfda-471c-9a16-1ffc532167c6 50090-1498 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20130812 ANDA ANDA040526 A-S Medication Solutions PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50090-1499_99db2e98-4432-4aab-8a15-470ed91836d9 50090-1499 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20130812 ANDA ANDA040526 A-S Medication Solutions PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50090-1501_b4df1f79-66ee-48f3-a732-82cc3d24067b 50090-1501 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130311 ANDA ANDA078703 A-S Medication Solutions PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-1502_d4486ae5-1ee1-45dc-ab41-650dc318026b 50090-1502 VACCINE HAVRIX Hepatitis A Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20070413 BLA BLA103475 A-S Medication Solutions HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 1440 [iU]/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 50090-1504_d68a494d-99fe-4c46-aba7-5abe6b1f2ec2 50090-1504 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 A-S Medication Solutions FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-1507_9f9d0380-adb4-4abe-a51b-05ec545a3f40 50090-1507 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130213 ANDA ANDA076063 A-S Medication Solutions LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-1519_02af03e5-400a-4614-94a0-a8b6b1059309 50090-1519 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 A-S Medication Solutions HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50090-1520_f2035708-e37a-4fcf-95b9-9f829e4671ea 50090-1520 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 A-S Medication Solutions HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50090-1524_d427fa85-a139-4b46-b7b5-0e603ee71963 50090-1524 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 A-S Medication Solutions KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50090-1526_54614b08-aa2f-4eb8-815a-3411d30b99c1 50090-1526 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 A-S Medication Solutions GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50090-1527_1ea2de41-078a-4f1c-94f5-1eab130a85b3 50090-1527 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 A-S Medication Solutions AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50090-1528_03c677f0-6aef-4a72-a5cf-d2a77322e2bd 50090-1528 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20090923 NDA AUTHORIZED GENERIC NDA012750 A-S Medication Solutions CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA],Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 50090-1531_14428872-e95e-4b47-801f-010f65f7bc53 50090-1531 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 A-S Medication Solutions NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-1533_bd5592e7-4502-4e34-bdda-8255aa6084d3 50090-1533 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 A-S Medication Solutions PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-1534_fde1f03b-4351-4ea6-a77f-078cd4fbbd92 50090-1534 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120217 ANDA ANDA202248 A-S Medication Solutions PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50090-1536_b76b2949-6f4b-4d6e-ae7e-cac16c0dd779 50090-1536 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100629 NDA NDA020381 A-S Medication Solutions NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 50090-1550_b2dc07ac-536b-4ba9-b752-2167e7a7196f 50090-1550 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 A-S Medication Solutions GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50090-1556_7608d6ea-015f-47b5-a38c-7624a8272df4 50090-1556 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 A-S Medication Solutions GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50090-1563_28b6e2ad-acc7-4422-be93-421d78ad9b69 50090-1563 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19931223 ANDA ANDA076704 A-S Medication Solutions METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-1566_396f30cc-3873-48e4-8b93-f7867fc1a0ff 50090-1566 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090917 ANDA ANDA078906 A-S Medication Solutions VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50090-1581_07a92e16-603b-4208-88e9-ed3399a3c3e6 50090-1581 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20030624 NDA NDA021567 A-S Medication Solutions ATAZANAVIR SULFATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 50090-1583_abfccd45-0669-4189-a428-552b80167a16 50090-1583 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 A-S Medication Solutions NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-1585_7a77f4a2-2282-4aef-b127-37ef76a80755 50090-1585 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 A-S Medication Solutions NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-1594_bd5592e7-4502-4e34-bdda-8255aa6084d3 50090-1594 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 A-S Medication Solutions PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-1597_da7f4dc5-0af5-4090-9554-9c567eee97c5 50090-1597 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 A-S Medication Solutions GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50090-1600_ae8a53e2-4e44-4dff-a8e0-1da21dcf59fd 50090-1600 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 A-S Medication Solutions ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 50090-1663_6e954358-f583-4b19-a100-c20af304a16d 50090-1663 HUMAN PRESCRIPTION DRUG Humalog KwikPen Insulin lispro INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20070906 NDA NDA020563 A-S Medication Solutions INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] N 20181231 50090-1666_ee6941d0-d560-44fe-b056-19a6cdfb061b 50090-1666 HUMAN PRESCRIPTION DRUG BICILLIN L-A penicillin G benzathine INJECTION, SUSPENSION INTRAMUSCULAR 19520627 NDA NDA050141 A-S Medication Solutions PENICILLIN G BENZATHINE 600000 [iU]/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50090-1691_ca40d09e-75c5-467e-8538-f9f9fa24d3cd 50090-1691 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 A-S Medication Solutions BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 50090-1702_b9d3c2b9-a9db-459d-8289-bd31467097f5 50090-1702 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19710401 ANDA ANDA061454 A-S Medication Solutions DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50090-1737_9f9d0380-adb4-4abe-a51b-05ec545a3f40 50090-1737 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130213 ANDA ANDA076063 A-S Medication Solutions LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-1742_aca91738-e761-4e0e-936c-b90e55ae5f7d 50090-1742 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040787 A-S Medication Solutions HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 50090-1743_c15ea798-8d97-40a5-96c7-f41790d91048 50090-1743 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040787 A-S Medication Solutions HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 50090-1938_aca91738-e761-4e0e-936c-b90e55ae5f7d 50090-1938 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040788 A-S Medication Solutions HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 50090-1950_9fbbb0b1-7900-435a-a89b-2cad792048de 50090-1950 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 A-S Medication Solutions SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 50090-1987_54614b08-aa2f-4eb8-815a-3411d30b99c1 50090-1987 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 A-S Medication Solutions GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50090-1989_ed0b3665-4c17-4dc9-b85f-1d0722144942 50090-1989 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 A-S Medication Solutions PREDNISONE 20 mg/1 N 20181231 50090-1990_41a0b67a-2c1f-401d-a0ea-e8f27543896d 50090-1990 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 A-S Medication Solutions PREDNISONE 20 mg/1 N 20181231 50090-2017_dc7fa505-bd6e-4dd8-a142-c3cdc8068e1e 50090-2017 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202910 A-S Medication Solutions IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50090-2060_98c9b33d-fdba-4e7e-84df-4a3bcfa64a21 50090-2060 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 A-S Medication Solutions FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 50090-2079_34f70866-a826-4bcc-83c5-d2b739234a24 50090-2079 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 A-S Medication Solutions CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 50090-2085_fb35ce13-b401-43f1-9f7f-43cdb79a79ac 50090-2085 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 A-S Medication Solutions HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-2086_fb35ce13-b401-43f1-9f7f-43cdb79a79ac 50090-2086 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 A-S Medication Solutions HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-2113_f08d05bd-517f-4a2f-983d-2b2df9cb5509 50090-2113 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140116 NDA AUTHORIZED GENERIC NDA018279 A-S Medication Solutions POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 50090-2114_f08d05bd-517f-4a2f-983d-2b2df9cb5509 50090-2114 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140116 NDA AUTHORIZED GENERIC NDA018279 A-S Medication Solutions POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 50090-2119_fe87c3b1-d372-46fa-8dc9-07b8e3851a5a 50090-2119 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 A-S Medication Solutions CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 50090-2121_20248b81-98c8-494d-b7c0-7476298027f5 50090-2121 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 A-S Medication Solutions HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 50090-2140_d70b0d30-da05-4c1d-b438-156c9513352e 50090-2140 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 A-S Medication Solutions MIRTAZAPINE 15 mg/1 N 20181231 50090-2142_7060813e-2937-4d30-a2bd-cadccde3bd41 50090-2142 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 A-S Medication Solutions LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50090-2143_dd4a4f31-4318-4280-be28-775024541cfa 50090-2143 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 A-S Medication Solutions PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50090-2144_5ac97c50-63e1-4d3b-a70e-dd9770aa18df 50090-2144 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 A-S Medication Solutions SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 50090-2171_e7e7d49c-5bd4-4ab3-acfb-589fe75a828f 50090-2171 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 A-S Medication Solutions HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50090-2175_fe87c3b1-d372-46fa-8dc9-07b8e3851a5a 50090-2175 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 A-S Medication Solutions CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 50090-2208_6b66cf74-77ab-47b0-92e2-faef9d3bc7ff 50090-2208 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20031211 ANDA ANDA076416 A-S Medication Solutions TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50090-2257_de02d4ab-6ddb-4889-854d-509055a856fa 50090-2257 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 A-S Medication Solutions POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 50090-2402_41a0b67a-2c1f-401d-a0ea-e8f27543896d 50090-2402 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 A-S Medication Solutions PREDNISONE 5 mg/1 N 20181231 50090-2423_7a751835-7a97-4b1f-a85d-336ca80372a5 50090-2423 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 A-S Medication Solutions HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 50090-2446_516b6d3b-d5d5-492d-b167-10e87ca70932 50090-2446 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20160627 ANDA ANDA062505 A-S Medication Solutions DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 50090-2475_b8827cf4-b6f2-42ca-bb10-7f8d96a28a78 50090-2475 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 A-S Medication Solutions RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-2498_223b715c-83d1-4637-989d-46a7c668a8c8 50090-2498 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 A-S Medication Solutions LEVOFLOXACIN 250 mg/1 N 20181231 50090-2531_da1aee4d-c5fc-45bd-a07a-4ce79ccbbb3e 50090-2531 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130617 ANDA ANDA202297 A-S Medication Solutions CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50090-2543_caeebcfa-0cf2-4a9f-8555-ddd4c3a30bcb 50090-2543 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20130902 ANDA ANDA078155 A-S Medication Solutions SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50090-2574_f6374d91-c95b-4c35-aa3c-a98ba6a82416 50090-2574 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 A-S Medication Solutions RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50090-2577_b8827cf4-b6f2-42ca-bb10-7f8d96a28a78 50090-2577 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 A-S Medication Solutions RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50090-2584_e698cc2e-6e1b-494c-ac71-210cd37cfba8 50090-2584 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090324 ANDA ANDA079095 A-S Medication Solutions BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50090-2600_da1aee4d-c5fc-45bd-a07a-4ce79ccbbb3e 50090-2600 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130617 ANDA ANDA202297 A-S Medication Solutions CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50090-2602_d1665e8e-6d16-4050-8844-fc2fe7d529f7 50090-2602 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20160627 ANDA ANDA062500 A-S Medication Solutions DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 50090-2615_482b54d9-3d6c-4367-8329-f45ed44151ac 50090-2615 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 A-S Medication Solutions PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50090-2704_4bc7aae2-2469-4ddf-bb89-3b5f280d5c11 50090-2704 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 A-S Medication Solutions ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 50090-2729_65a4088c-d89a-4b2e-ad45-762b8691485f 50090-2729 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073516 A-S Medication Solutions KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-2817_70981a97-452b-4595-a77e-6519679c653f 50090-2817 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 A-S Medication Solutions HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50090-2875_0f9c3d06-3b28-4b34-b463-6676fe06c7c6 50090-2875 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120109 ANDA ANDA090515 A-S Medication Solutions LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50090-2996_a362a834-2b8b-44fc-979e-03bec227acba 50090-2996 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 A-S Medication Solutions IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50090-3005_6c6b0037-6273-4041-9f92-26eddcbe77e4 50090-3005 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 A-S Medication Solutions AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 50090-3130_b36e1a18-8820-4a91-a4e1-c1b31d0e37f6 50090-3130 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20091010 ANDA ANDA076126 A-S Medication Solutions CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50093-001_4032003d-dd6e-4695-a300-05184598cb93 50093-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100209 UNAPPROVED MEDICAL GAS Centrad Healthcare, LLC OXYGEN 995 mL/L E 20171231 50096-502_533186fe-abfd-34f4-e054-00144ff88e88 50096-502 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser SULFACETAMIDE SODIUM, SULFUR LIQUID TOPICAL 20050901 UNAPPROVED DRUG OTHER Rosemar Labs, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 50096-503_4db0d67d-a2d0-228a-e054-00144ff88e88 50096-503 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cream SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20050901 UNAPPROVED DRUG OTHER Rosemar Labs, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 50096-505_4db1ade6-b7a0-0024-e054-00144ff8d46c 50096-505 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 9.8% and Sulfur 4.8% SULFACETAMIDE SODIUM, SULFUR LOTION TOPICAL 20050901 UNAPPROVED DRUG OTHER Rosemar Labs, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 50101-0001_40e80052-9d05-49d4-b280-f3684a8ab96a 50101-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090903 UNAPPROVED MEDICAL GAS Laramie Respiratory Service OXYGEN 99 L/100L E 20171231 50102-100_230b1884-dd75-444c-a430-624a863a5195 50102-100 HUMAN PRESCRIPTION DRUG LYZA norethindrone TABLET ORAL 20130624 ANDA ANDA200980 Afaxys Pharma LLC NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 50102-111_5e7ced25-334b-4ac8-a3d2-b1b7113ce15b 50102-111 HUMAN OTC DRUG ECONTRA EZ levonorgestrel TABLET ORAL 20150101 ANDA ANDA202739 Afaxys Pharma, LLC LEVONORGESTREL 1.5 mg/1 N 20181231 50102-120_d301a49d-1dc6-47da-acd4-ba6a3364794b 50102-120 HUMAN PRESCRIPTION DRUG AUBRA Levonorgestrel and Ethinyl Estradiol KIT 20131015 ANDA ANDA200245 Afaxys Pharma, LLC N 20181231 50102-128_16309133-4917-46f2-b037-d82ef8e7ca22 50102-128 HUMAN PRESCRIPTION DRUG TARINA Fe 1/20 norethindrone acetate and ethinyl estradiol KIT 20140915 ANDA ANDA202772 Afaxys Pharma, LLC. N 20181231 50102-130_5f148660-29d0-4e51-967a-481e42ebe981 50102-130 HUMAN PRESCRIPTION DRUG CHATEAL levonorgestrel and ethinyl estradiol KIT 20130122 ANDA ANDA091663 Afaxys Pharma, LLC N 20181231 50102-154_204bc5fe-c4d3-4323-868a-1e2b24585c27 50102-154 HUMAN PRESCRIPTION DRUG CYRED desogestrel and ethinyl estradiol KIT 20150807 ANDA ANDA202085 Afaxys Pharma, LLC N 20181231 50102-233_f59acc3e-21d9-4fa3-ad52-d77225739e1a 50102-233 HUMAN PRESCRIPTION DRUG Tri-VyLibra Norgestimate and Ethinyl Estradiol KIT 20160706 ANDA ANDA205441 Afaxys Pharma, LLC N 20191231 50102-235_13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc3 50102-235 HUMAN PRESCRIPTION DRUG VyLibra norgestimate and ethinyl estradiol KIT 20160707 ANDA ANDA205449 Afaxys Pharma, LLC N 20191231 50102-911_1f254340-663e-4931-bc07-ab7f0aecd829 50102-911 HUMAN PRESCRIPTION DRUG ella ulipristal acetate TABLET ORAL 20100813 NDA NDA022474 Afaxys Pharma LLC ULIPRISTAL ACETATE 30 mg/1 Selective Progesterone Receptor Modulators [MoA],Progesterone Agonist/Antagonist [EPC] N 20181231 50107-100_dd6beeaf-c547-43cc-88e0-ffe9b64d9900 50107-100 HUMAN OTC DRUG Reme-Flu BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , KIT 20091222 UNAPPROVED HOMEOPATHIC Legacy Biotechnologies Inc. E 20171231 50111-323_0a02e7f6-173e-460c-9752-2aa3d4f68663 50111-323 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 19900930 ANDA ANDA089095 Teva Pharmaceuticals USA, Inc. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 50111-324_0a02e7f6-173e-460c-9752-2aa3d4f68663 50111-324 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 19900930 ANDA ANDA088440 Teva Pharmaceuticals USA, Inc. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 50111-325_0a02e7f6-173e-460c-9752-2aa3d4f68663 50111-325 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 19900930 ANDA ANDA088441 Teva Pharmaceuticals USA, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 50111-326_0a02e7f6-173e-460c-9752-2aa3d4f68663 50111-326 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 19900930 ANDA ANDA089096 Teva Pharmaceuticals USA, Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 50111-327_63be284c-b10b-4457-ac58-c73d7751127a 50111-327 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA088467 Teva Pharmaceuticals USA, Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 50111-328_63be284c-b10b-4457-ac58-c73d7751127a 50111-328 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA088468 Teva Pharmaceuticals USA, Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 50111-333_58a991f0-0bc2-49d3-8498-97a9eb2f725f 50111-333 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 Teva Pharmaceuticals USA, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 50111-334_58a991f0-0bc2-49d3-8498-97a9eb2f725f 50111-334 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 Teva Pharmaceuticals USA, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 50111-397_63be284c-b10b-4457-ac58-c73d7751127a 50111-397 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA089098 Teva Pharmaceuticals USA, Inc. HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 50111-398_63be284c-b10b-4457-ac58-c73d7751127a 50111-398 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA089097 Teva Pharmaceuticals USA, Inc. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 50111-433_3a0fdd33-63b8-4c33-8ea0-9b48ce46563b 50111-433 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Teva Pharmaceuticals USA, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 50111-434_3a0fdd33-63b8-4c33-8ea0-9b48ce46563b 50111-434 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 Teva Pharmaceuticals USA, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 50111-441_3a0fdd33-63b8-4c33-8ea0-9b48ce46563b 50111-441 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Teva Pharmaceuticals USA, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 50111-456_3477bc1d-4679-4458-9232-e2edbb17ca33 50111-456 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 19900930 ANDA ANDA071655 Pliva Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 50111-459_61621021-ef1c-4815-a26c-0840e11153ce 50111-459 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089763 Teva Pharmaceuticals USA, Inc. THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 50111-467_f8400547-0d8f-449f-ba91-476555e2ca01 50111-467 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 20190331 ANDA ANDA071972 Teva Pharmaceuticals USA, Inc. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50111-468_f8400547-0d8f-449f-ba91-476555e2ca01 50111-468 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 20190331 ANDA ANDA071973 Teva Pharmaceuticals USA, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50111-469_f8400547-0d8f-449f-ba91-476555e2ca01 50111-469 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 20190430 ANDA ANDA071974 Teva Pharmaceuticals USA, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50111-470_f8400547-0d8f-449f-ba91-476555e2ca01 50111-470 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 20190228 ANDA ANDA071975 Teva Pharmaceuticals USA, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50111-471_f8400547-0d8f-449f-ba91-476555e2ca01 50111-471 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 20190430 ANDA ANDA071976 Teva Pharmaceuticals USA, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50111-482_61621021-ef1c-4815-a26c-0840e11153ce 50111-482 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089808 Teva Pharmaceuticals USA, Inc. THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 50111-483_61621021-ef1c-4815-a26c-0840e11153ce 50111-483 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089807 Teva Pharmaceuticals USA, Inc. THEOPHYLLINE ANHYDROUS 100 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 50111-518_61621021-ef1c-4815-a26c-0840e11153ce 50111-518 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19931031 ANDA ANDA081236 Teva Pharmaceuticals USA, Inc. THEOPHYLLINE ANHYDROUS 450 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 50111-647_31c52c6a-2fb4-41aa-9522-138b69004a79 50111-647 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Teva Pharmaceuticals USA, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50111-648_31c52c6a-2fb4-41aa-9522-138b69004a79 50111-648 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Teva Pharmaceuticals USA, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50111-787_ed44df6e-7f3c-49fa-b137-4a9ac926d205 50111-787 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 Teva Pharmaceuticals USA, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50111-788_ed44df6e-7f3c-49fa-b137-4a9ac926d205 50111-788 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065223 Teva Pharmaceuticals USA, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50111-789_e78f742a-1e63-4db5-b146-5e3088b56a8a 50111-789 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051201 ANDA ANDA065218 Teva Pharmaceuticals USA, Inc. AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50111-915_397b348c-a9fe-4c82-a20d-67bfc81c8b0e 50111-915 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20040601 ANDA ANDA076346 Teva Pharmaceuticals USA, Inc. TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50111-916_397b348c-a9fe-4c82-a20d-67bfc81c8b0e 50111-916 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20040601 ANDA ANDA076346 Teva Pharmaceuticals USA, Inc. TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50111-917_397b348c-a9fe-4c82-a20d-67bfc81c8b0e 50111-917 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20040601 ANDA ANDA076346 Teva Pharmaceuticals USA, Inc. TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50111-918_397b348c-a9fe-4c82-a20d-67bfc81c8b0e 50111-918 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20041020 ANDA ANDA076346 Teva Pharmaceuticals USA, Inc. TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50112-514_8ed3fc29-b4cc-4bda-a674-0da3085169e9 50112-514 HUMAN OTC DRUG Envirokleen Non-Alcohol Instant Hand Sanitizer Husky 514 SOLUTION TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part333 EnviroKleen LLC BENZALKONIUM CHLORIDE 1 g/mL E 20171231 50112-515_250723d7-ec8a-4f2b-a09c-ffda6b655944 50112-515 HUMAN OTC DRUG Envirokleen Instant Hand Sanitizer alcohol GEL TOPICAL 20110309 OTC MONOGRAPH NOT FINAL part333E EnviroKleen LLC ALCOHOL 600 mL/1000mL E 20171231 50114-0110_cdc6114c-1b6f-4329-a612-fdc1535b6c06 50114-0110 HUMAN OTC DRUG Solidago Compositum SOLIDAGO VIRGAUREA FLOWERING TOP and BAPTISIA TINCTORIA ROOT and BERBERIS VULGARIS ROOT BARK and EQUISETUM HYEMALE and SILVER NITRATE and LYTTA VESICATORIA and CAPSICUM and CUPRIC SULFATE and CLERODENDRANTHUS SPICATUS LEAF and CHONDRODENDRON TOMENTOSUM ROOT and SMILAX REGELII ROOT and TURPENTINE OIL and APIS MELLIFERA VENOM and AGATHOSMA BETULINA LEAF and HUMAN COXSACKIEVIRUS A and MERCURIC CHLORIDE and SUS SCROFA URINARY BLADDER and CALCIUM SULFIDE and SODIUM PYRUVATE SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc SOLIDAGO VIRGAUREA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; SILVER NITRATE; LYTTA VESICATORIA; CAPSICUM; CUPRIC SULFATE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; TURPENTINE OIL; APIS MELLIFERA VENOM; AGATHOSMA BETULINA LEAF; HUMAN COXSACKIEVIRUS A; MERCURIC CHLORIDE; SUS SCROFA URINARY BLADDER; CALCIUM SULFIDE; SODIUM PYRUVATE; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; ESCHERICHIA COLI; ARSENIC TRIOXIDE 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 13; 28 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL E 20171231 50114-1075_a05a3b66-3e1a-4453-82a4-34b178720003 50114-1075 HUMAN OTC DRUG Hormeel AQUILEGIA VULGARIS and ORIGANUM MAJORANA WHOLE and NITRIC ACID and NUTMEG and OYSTER SHELL CALCIUM CARBONATE, CRUDE and CYPRIPEDIUM PARVIFOLUM ROOT and CONYZA CANADENSIS and CAPSELLA BURSA-PASTORIS and VIBURNUM OPULUS BARK and CYCLAMEN PURPURASCENS TUBER and PULSATILLA VULGARIS and SEPIA OFFICINALIS JUICE and STRYCHNOS IGNATII SEED and MOSCHUS MOSCHIFERUS MUSK SAC RESIN LIQUID ORAL 19951120 UNAPPROVED HOMEOPATHIC Heel Inc AQUILEGIA VULGARIS; ORIGANUM MAJORANA WHOLE; NITRIC ACID; NUTMEG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CYPRIPEDIUM PARVIFOLUM ROOT; CONYZA CANADENSIS; CAPSELLA BURSA-PASTORIS; VIBURNUM OPULUS BARK; CYCLAMEN PURPURASCENS TUBER; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS MUSK SAC RESIN 4; 4; 6; 6; 8; 8; 3; 3; 3; 4; 4; 4; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL E 20171231 50114-1165_9f8cf8e1-df0f-43c5-ad97-f3ae07f5c127 50114-1165 HUMAN OTC DRUG Valerianaheel VALERIAN and TRINITROPHENOL and PRUNUS SPINOSA FLOWER BUD and HOPS and HYPERICUM PERFORATUM and MELISSA OFFICINALIS and AVENA SATIVA FLOWERING TOP and MATRICARIA RECUTITA and AMMONIUM BROMIDE and POTASSIUM BROMIDE and SODIUM BROMIDE LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc VALERIAN; TRINITROPHENOL; PRUNUS SPINOSA FLOWER BUD; HOPS; HYPERICUM PERFORATUM; MELISSA OFFICINALIS; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; AMMONIUM BROMIDE; POTASSIUM BROMIDE; SODIUM BROMIDE 2; 6; 2; 2; 3; 2; 2; 2; 2; 2; 2 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mm/50mL; [hp_X]/50mL E 20171231 50114-1220_3d6e9e55-5ae5-4f69-ba6a-57a155791e23 50114-1220 HUMAN OTC DRUG Cimicifuga Homaccord BLACK COHOSH and STRONTIUM CARBONATE and LIQUID ORAL 19860131 UNAPPROVED HOMEOPATHIC Heel Inc BLACK COHOSH; STRONTIUM CARBONATE 2; 8 [hp_X]/50mL; [hp_X]/50mL E 20171231 50114-3250_d13fa4ba-b63a-41ef-aaae-7636eeba7e8d 50114-3250 HUMAN OTC DRUG Sinusin PULSATILLA VULGARIS and EUPHORBIA RESINIFERA RESIN and LUFFA OPERCULATA FRUIT and MERCURIC IODIDE and SILVER NITRATE and CALCIUM SULFIDE and SINUSITISINUM and INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) LIQUID ORAL 20070131 UNAPPROVED HOMEOPATHIC Heel Inc PULSATILLA VULGARIS; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SILVER NITRATE; CALCIUM SULFIDE; SINUSITISINUM; INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED); INFLUENZA A VIRUS A/BEIJING/32/92 (H3N2) HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED); INFLUENZA B VIRUS B/PANAMA/45/90 HEMAGGLUTININ ANTIGEN (HEAT INACTIVATED) 2; 6; 6; 6; 10; 10; 13; 8; 8; 8 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL E 20171231 50114-4262_891a55df-7722-4dd6-b53f-4b5c5d4e0065 50114-4262 HUMAN OTC DRUG Back CITRULLUS COLOCYNTHIS FRUIT PULP and PSEUDOGNAPHALIUM OBTUSIFOLIUM and AMMONIUM CHLORIDE and GELSEMIUM SEMPERVIRENS ROOT and TOXICODENDRON PUBESCENS LEAF and ARSENIC TRIOXIDE and MATRICARIA RECUTITA and TABLET ORAL 20070830 UNAPPROVED HOMEOPATHIC Heel Inc. CITRULLUS COLOCYNTHIS FRUIT PULP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; AMMONIUM CHLORIDE; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF; ARSENIC TRIOXIDE; MATRICARIA RECUTITA 5; 5; 6; 6; 8; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 50114-4426_01a0c80e-4016-4cf7-b543-392ab1e7e4a3 50114-4426 HUMAN OTC DRUG Body Pure .ALPHA.-LIPOIC ACID and AVENA SATIVA FLOWERING TOP and RICINUS COMMUNIS SEED and SOLIDAGO VIRGAUREA FLOWERING TOP and VIOLA TRICOLOR and BERBERIS VULGARIS ROOT BARK and CAFFEINE and JUGLANS REGIA FLOWERING TOP and FRANGULA PURSHIANA BARK and URTICA URENS and CHOLESTEROL and INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) ANTIGEN (HEAT INACTIVATED) and KEROSENE and TOBACCO LEAF and ALCOHOL, X-RAY EXPOSED (1000 RAD) and STRYCHNOS NUX-VOMICA SEED TABLET ORAL 20070830 UNAPPROVED HOMEOPATHIC Heel Inc .ALPHA.-LIPOIC ACID; AVENA SATIVA FLOWERING TOP; RICINUS COMMUNIS SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; VIOLA TRICOLOR; BERBERIS VULGARIS ROOT BARK; CAFFEINE; JUGLANS REGIA FLOWERING TOP; FRANGULA PURSHIANA BARK; URTICA URENS; CHOLESTEROL; INFLUENZA A VIRUS A/SINGAPORE/6/86 (H1N1) ANTIGEN (HEAT INACTIVATED); KEROSENE; TOBACCO LEAF; ALCOHOL, X-RAY EXPOSED (1000 RAD); STRYCHNOS NUX-VOMICA SEED 3; 3; 3; 4; 4; 6; 6; 6; 6; 6; 10; 12; 12; 12; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_Q]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 50114-5324_6bd1d376-97d2-4876-96e6-31c7ad4903cb 50114-5324 HUMAN PRESCRIPTION DRUG Psorinoheel SULFUR, THUJA OCCIDENTALIS LEAFY TWIG, VACCINIA VIRUS STRAIN NEW YORK CITY BOARD, GONORRHEAL URETHRAL SECRETION HUMAN,SODIUM CHLORIDE, NERIUM OLEANDER LEAF,CICUTA VIROSA ROOT, SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN; BUFO BUFO CUTANEOUS GLAND; SCABIES LESION LYSATE (HUMAN); GONORRHEAL URETHRAL SECRETION HUMAN; NERIUM OLEANDER LEAF; CICUTA VIROSA ROOT; POTASSIUM DICHROMATE 6; 6; 8; 10; 10; 12; 4; 5; 5 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL Live Vaccinia Virus Vaccine [EPC],Actively Acquired Immunity [PE],Smallpox Vaccine [Chemical/Ingredient],Vaccines, Live, Unattenuated [Chemical/Ingredient] E 20171231 50114-6085_fb7148f6-313c-4225-b4f4-9230c6c6690a 50114-6085 HUMAN OTC DRUG Klimaktheel LACHESIS MUTA VENOM and TIN and SANGUINARIA CANADENSIS ROOT and SIMABA CEDRON SEED and STRYCHNOS IGNATII SEED and SEPIA OFFICINALIS JUICE and SULFUR TABLET ORAL 19840131 UNAPPROVED HOMEOPATHIC Heel Inc LACHESIS MUTA VENOM; TIN; SANGUINARIA CANADENSIS ROOT; SIMABA CEDRON SEED; STRYCHNOS IGNATII SEED; SEPIA OFFICINALIS JUICE; SULFUR 12; 12; 3; 4; 4; 4; 4 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg E 20171231 50114-6110_eeb47dac-a7c9-4559-93b0-2798b2a7cf47 50114-6110 HUMAN OTC DRUG Oculoheel SPIGELIA ANTHELMIA and CALCIUM SULFIDE and TOXICODENDRON PUBESCENS LEAF and DELPHINIUM STAPHISAGRIA SEED and APIS MELLIFERA and SODIUM CHLORIDE and MERCURIC SULFIDE TABLET ORAL 19840131 UNAPPROVED HOMEOPATHIC Heel Inc SPIGELIA ANTHELMIA; CALCIUM SULFIDE; TOXICODENDRON PUBESCENS LEAF; DELPHINIUM STAPHISAGRIA SEED; APIS MELLIFERA; SODIUM CHLORIDE; MERCURIC SULFIDE 6; 12; 12; 4; 4; 6; 8 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg E 20171231 50114-6129_eab7b089-635c-472d-a952-8ad4f063ae0c 50114-6129 HUMAN OTC DRUG Spascupreel ACONITUM NAPELLUS and AMMONIUM BROMIDE and CITRULLUS COLOCYNTHIS FRUIT PULP and ATROPINE SULFATE and GELSEMIUM SEMPERVIRENS ROOT and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE and VERATRUM ALBUM ROOT and PASSIFLORA INCARNATA FLOWERING TOP and MATRICARIA RECUTITA and AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY and CUPRIC SULFATE SOLUTION ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc ACONITUM NAPELLUS; AMMONIUM BROMIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; ATROPINE SULFATE; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; VERATRUM ALBUM ROOT; PASSIFLORA INCARNATA FLOWERING TOP; MATRICARIA RECUTITA; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; CUPRIC SULFATE 6; 4; 4; 6; 6; 6; 6; 2; 3; 4; 6 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL E 20171231 50114-6134_0183c6a7-6195-451c-9eef-81d60c769d4f 50114-6134 HUMAN OTC DRUG Abropernol ARTEMISIA ABROTANUM FLOWERING TOP and PULSATILLA VULGARIS and CALCIUM FLUORIDE and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY and NITRIC ACID and KEROSEN TABLET ORAL 19840131 UNAPPROVED HOMEOPATHIC Heel Inc ARTEMISIA ABROTANUM FLOWERING TOP; PULSATILLA VULGARIS; CALCIUM FLUORIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; NITRIC ACID; KEROSENE 4; 4; 12; 4; 5; 6; 6 [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg; [hp_X]/300mg E 20171231 50114-6141_8c1438b4-65d2-4dcf-b23d-9b495f7efa89 50114-6141 HUMAN OTC DRUG Coenzyme Compositum BETA VULGARIS and ASCORBIC ACID and CYSTEINE and MAGNESIUM OROTATE and MANGANESE PHOSPHATE, DIBASIC and SODIUM DIETHYL OXALACETATE and NIACINAMIDE and PULSATILLA VULGARIS and PYRIDOXINE HYDROCHLORIDE and RIBOFLAVIN and THIAMINE HYDROCHLORIDE and .ALPHA.-LIPOIC ACID and .ALPHA.-KETOGLUTARIC ACID and CEROUS OXALATE NONAHYDRATE and ACONITIC ACID, (Z)- and ANHYDROUS CITRIC ACID and COENZYME A and FUMARIC ACID and MALIC ACID and NADIDE and SODIUM PYRUVATE and SUCCINIC ACID TABLET ORAL 20030831 UNAPPROVED HOMEOPATHIC Heel Inc BETA VULGARIS; ASCORBIC ACID; CYSTEINE; MAGNESIUM OROTATE; MANGANESE PHOSPHATE, DIBASIC; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; .ALPHA.-LIPOIC ACID; .ALPHA.-KETOGLUTARIC ACID; CEROUS OXALATE NONAHYDRATE; ACONITIC ACID, (Z)-; ANHYDROUS CITRIC ACID; COENZYME A; FUMARIC ACID; MALIC ACID; NADIDE; SODIUM PYRUVATE; SUCCINIC ACID; ADENOSINE TRIPHOSPHATE; BARIUM OXALOSUCCINATE; CALCIUM SULFIDE; SULFUR 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 50114-6922_f5e8083a-dccf-4b62-b5b4-6060e12c3f3e 50114-6922 HUMAN PRESCRIPTION DRUG BHI Mucus ANTIMONY POTASSIUM TARTRATE,ATROPA BELLADONNA,BRYONIA ALBA ROOT,ANEMONE AMERICANA,HYOSCYAMUS NIGER,IPECAC,LOBELIA INFLATA,HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED, and LOBARIA PULMONARIA TABLET ORAL 19930131 UNAPPROVED HOMEOPATHIC Heel Inc ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; ANEMONE AMERICANA; HYOSCYAMUS NIGER; IPECAC; LOBELIA INFLATA; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; LOBARIA PULMONARIA 5; 6; 6; 6; 5; 6; 4; 30; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 50114-7004_a424b304-b16c-46eb-9272-0de7d580bc66 50114-7004 HUMAN PRESCRIPTION DRUG Traumeel ARNICA MONTANA ROOT, ATROPA BELLADONNA, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ACHILLEA MILLEFOLIUM, CALCIUM SULFIDE, COMFREY ROOT, ACONITUM NAPELLUS, BELLIS PERENNIS, MERCURIUS SOLUBILIS, HYPERICUM PERFORATUM, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK INJECTION INTRA-ARTICULAR; INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20070509 UNAPPROVED HOMEOPATHIC Medinatura ARNICA MONTANA ROOT; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ACHILLEA MILLEFOLIUM; CALCIUM SULFIDE; COMFREY ROOT; ACONITUM NAPELLUS; BELLIS PERENNIS; MERCURIUS SOLUBILIS; HYPERICUM PERFORATUM; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 2; 2; 2; 3; 3; 6; 6; 2; 2; 6; 2; 2; 2; 1 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL N 20181231 50114-7015_b543d3c7-4cbf-431d-b11a-c5bd26af355c 50114-7015 HUMAN PRESCRIPTION DRUG Engystol CYNANCHUM VINCETOXICUM ROOT and SULFUR INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140531 UNAPPROVED HOMEOPATHIC MediNatura CYNANCHUM VINCETOXICUM ROOT; SULFUR 6; 4 [hp_X]/1.1mL; [hp_X]/1.1mL N 20191231 50114-7030_87a0d8ef-46b5-4dff-bf88-91f8074bcd49 50114-7030 HUMAN PRESCRIPTION DRUG Zeel ARNICA MONTANA ROOT, TOXICODENDRON PUBESCENS LEAF, SOLANUM DULCAMARA TOP, COMFREY ROOT, SULFUR, SANGUINARIA CANADENSIS ROOT, SUS SCROFA CARTILAGE, SUS SCROFA EMBRYO, SUS SCROFA UMBILICAL CORD, SUS SCROFA PLACENTA, .ALPHA.-LIPOIC ACID, COENZYME A, NADIDE and SODIUM DIETHYL OXALACETATE INJECTION INTRA-ARTICULAR; INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140731 UNAPPROVED HOMEOPATHIC MediNatura ARNICA MONTANA ROOT; TOXICODENDRON PUBESCENS LEAF; SOLANUM DULCAMARA TOP; COMFREY ROOT; SULFUR; SANGUINARIA CANADENSIS ROOT; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA UMBILICAL CORD; SUS SCROFA PLACENTA; .ALPHA.-LIPOIC ACID; COENZYME A; NADIDE; SODIUM DIETHYL OXALACETATE 4; 2; 3; 6; 6; 4; 6; 6; 6; 6; 8; 8; 8; 8 [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL N 20181231 50114-7040_69204e74-f947-48ae-8029-053723e8b5b1 50114-7040 HUMAN PRESCRIPTION DRUG Spascupreel ACONITUM NAPELLUS, AMMONIUM BROMIDE, CITRULLUS COLOCYNTHIS FRUIT PULP, ATROPINE SULFATE, GELSEMIUM SEMPERVIRENS ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, VERATRUM ALBUM ROOT, PASSIFLORA INCARNATA FLOWERING TOP, MATRICARIA RECUTITA, AMANITA MUSCARIA FRUITING BODY and CUPRIC SULFATE INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110120 UNAPPROVED HOMEOPATHIC MediNatura Inc ACONITUM NAPELLUS; AMMONIUM BROMIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; ATROPINE SULFATE; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; VERATRUM ALBUM ROOT; PASSIFLORA INCARNATA FLOWERING TOP; MATRICARIA RECUTITA; AMANITA MUSCARIA FRUITING BODY; CUPRIC SULFATE 6; 4; 4; 6; 6; 6; 6; 2; 3; 4; 6 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 50114-7041_b56ceb53-f812-40b1-967e-72a85d653e62 50114-7041 HUMAN PRESCRIPTION DRUG Thyreoidea Compositum LACTIC ACID, L- and VISCUM ALBUM and COLCHICUM AUTUMNALE BULB and CONIUM MACULATUM FLOWERING TOP and GALIUM APARINE and FUCUS VESICULOSUS and SEDUM ACRE and SEMPERVIVUM TECTORUM LEAF and ADENOSINE TRI INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110708 UNAPPROVED HOMEOPATHIC Heel Inc LACTIC ACID, L-; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; GALIUM APARINE; FUCUS VESICULOSUS; SEDUM ACRE; SEMPERVIVUM TECTORUM LEAF; ADENOSINE TRIPHOSPHATE; FUMARIC ACID; .ALPHA.-KETOGLUTARIC ACID; MALIC ACID; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYROID; CALCIUM FLUORIDE; SUS SCROFA UMBILICAL CORD; PORK LIVER; SUS SCROFA BONE MARROW; SUS SCROFA SPLEEN; SULFUR; SUS SCROFA THYMUS; VISCUM ALBUM FRUIT; CORTISONE ACETATE 3; 4; 4; 4; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 3; 28 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 50114-7055_cc3f0e8b-fc8c-4a62-b3e7-d70b061977e4 50114-7055 HUMAN PRESCRIPTION DRUG Placenta Compositum HORSE CHESTNUT and LACTIC ACID, L- and CLAVICEPS PURPUREA SCLEROTIUM and CUPRIC SULFATE and MELILOTUS OFFICINALIS TOP and SUS SCROFA PLACENTA and SOLANUM NIGRUM WHOLE and STROPHANTHUS HISPIDUS SEED and SUS SCROFA EMBRYO and SODIUM PYRUVATE and SUS SCROFA VEIN and SUS SCROFA ARTERY and SUS SCROFA UMBILICAL CORD and TOBACCO LEAF and VIPERA BERUS VENOM and BARIUM CARBONATE and LEAD IODIDE INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20090430 UNAPPROVED HOMEOPATHIC Heel Inc HORSE CHESTNUT; LACTIC ACID, L-; CLAVICEPS PURPUREA SCLEROTIUM; CUPRIC SULFATE; MELILOTUS OFFICINALIS TOP; SUS SCROFA PLACENTA; SOLANUM NIGRUM WHOLE; STROPHANTHUS HISPIDUS SEED; SUS SCROFA EMBRYO; SODIUM PYRUVATE; SUS SCROFA VEIN; SUS SCROFA ARTERY; SUS SCROFA UMBILICAL CORD; TOBACCO LEAF; VIPERA BERUS VENOM; BARIUM CARBONATE; LEAD IODIDE 4; 4; 4; 6; 6; 6; 6; 6; 8; 8; 8; 10; 10; 10; 10; 13; 18 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] E 20171231 50114-7070_61f38ebe-0441-4b8d-be15-0b3fed1da6c2 50114-7070 HUMAN PRESCRIPTION DRUG Neuralgo Rheum PSEUDOGNAPHALIUM OBTUSIFOLIUM, CAUSTICUM, COLCHICUM AUTUMNALE BULB, CITRULLUS COLOCYNTHIS FRUIT PULP, IRON, LITHIUM BENZOATE, TOXICODENDRON PUBESCENS LEAF and FILIPENDULA ULMARIA ROOT INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140708 UNAPPROVED HOMEOPATHIC MediNatura Inc PSEUDOGNAPHALIUM OBTUSIFOLIUM; CAUSTICUM; COLCHICUM AUTUMNALE BULB; CITRULLUS COLOCYNTHIS FRUIT PULP; IRON; LITHIUM BENZOATE; TOXICODENDRON PUBESCENS LEAF; FILIPENDULA ULMARIA ROOT 6; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL Mood Stabilizer [EPC] N 20181231 50114-7110_68dcd90d-95e7-41e1-b527-449af5f287ab 50114-7110 HUMAN PRESCRIPTION DRUG Traumeel ARNICA MONTANA ROOT and ATROPA BELLADONNA and ACONITUM NAPELLUS and HYPERICUM PERFORATUM and CALENDULA OFFICINALIS FLOWERING TOP and MATRICARIA RECUTITA and ACHILLEA MILLEFOLIUM and CALCIUM SULFIDE and COMFREY ROOT and BELLIS PERENNIS and MERCURIUS SOLUBILIS and ECHINACEA, UNSPECIFIED and ECHINACEA PURPUREA and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK SOLUTION/ DROPS ORAL 20020930 UNAPPROVED HOMEOPATHIC Heel Inc ARNICA MONTANA ROOT; ATROPA BELLADONNA; ACONITUM NAPELLUS; HYPERICUM PERFORATUM; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ACHILLEA MILLEFOLIUM; CALCIUM SULFIDE; COMFREY ROOT; BELLIS PERENNIS; MERCURIUS SOLUBILIS; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 3; 3; 3; 3; 2; 3; 3; 6; 6; 2; 6; 2; 2; 1 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 50114-8015_1051dac8-cc5d-4223-b13b-eaddea62eee2 50114-8015 HUMAN OTC DRUG Traumeel CALENDULA OFFICINALIS FLOWERING TOP and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and ARNICA MONTANA ROOT and ACONITUM NAPELLUS and ATROPA BELLADONNA and BELLIS PERENNIS and MATRICARIA RECUTITA and ECHINACEA, UNSPECIFIED and ECHINACEA PURPUREA and ACHILLEA MILLEFOLIUM and CALCIUM SULFIDE and MERCURIUS SOLUBILIS and COMFREY ROOT and HYPERICUM PERFORATUM and GEL TOPICAL 19991031 UNAPPROVED HOMEOPATHIC Heel Inc CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ARNICA MONTANA ROOT; ACONITUM NAPELLUS; ATROPA BELLADONNA; BELLIS PERENNIS; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; ACHILLEA MILLEFOLIUM; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; COMFREY ROOT; HYPERICUM PERFORATUM 1; 1; 3; 3; 3; 1; 1; 1; 1; 1; 8; 8; 4; 6 [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g; [hp_X]/250g E 20171231 50114-8200_79c25951-d629-45d6-a570-d5ee08a09a3a 50114-8200 HUMAN PRESCRIPTION DRUG Lymphomyosot X ARANEUS DIADEMATUS, TRIBASIC CALCIUM PHOSPHATE, EQUISETUM HYEMALE, FERROUS IODIDE,FUMARIA OFFICINALIS FLOWERING TOP, GENTIANA LUTEA ROOT, GERANIUM ROBERTIANUM, MYOSOTIS ARVENSIS, NASTURTIUM OFFICINALE, SODIUM SULFATE, PINUS SYLVESTRIS LEAFY TWIG,SMILAX REGELII ROOT, SCROPHULARIA NODOSA, TEUCRIUM SCORODONIA FLOWERING TOP, THYROID, UNSPECIFIED andVERONICA OFFICINALIS FLOWERING TOP INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100401 UNAPPROVED HOMEOPATHIC MediNatura ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; SMILAX REGELII ROOT; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; THYROID, UNSPECIFIED; VERONICA OFFICINALIS FLOWERING TOP 6; 12; 12; 3; 4; 5; 4; 3; 4; 4; 4; 6; 3; 3; 12; 3 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 50114-8510_4081b17d-14e8-4aed-ab4e-8d962d417af6 50114-8510 HUMAN OTC DRUG Nectadyn DROSERA ROTUNDIFOLIA and IPECAC and RUMEX CRISPUS ROOT and ANTIMONY POTASSIUM TARTRATE and CUPRIC SULFATE and SPONGIA OFFICINALIS SKELETON, ROASTED SYRUP ORAL 20070831 UNAPPROVED HOMEOPATHIC Heel Inc DROSERA ROTUNDIFOLIA; IPECAC; RUMEX CRISPUS ROOT; ANTIMONY POTASSIUM TARTRATE; CUPRIC SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED 4; 4; 4; 6; 6; 8 [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL E 20171231 50114-8550_ba1d7b8e-0475-40f3-9fef-5b20fb600ec0 50114-8550 HUMAN OTC DRUG Reboost ANTIMONY POTASSIUM TARTRATE SYRUP ORAL 20130213 UNAPPROVED HOMEOPATHIC Heel Inc ANTIMONY POTASSIUM TARTRATE; CUPRIC SULFATE; DROSERA ROTUNDIFOLIA; IPECAC; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 4; 4; 4; 8 [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL E 20171231 50114-9001_1322684e-33d8-49ae-8215-728e44cc3c21 50114-9001 HUMAN PRESCRIPTION DRUG WellMind Vertigo SEMECARPUS ANACARDIUM JUICE, ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, KEROSENE, and SELENIUM TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC MediNatura Inc. SEMECARPUS ANACARDIUM JUICE; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; PETROLEUM ALKYLATE; SELENIUM 6; 4; 3; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 50114-9002_dbe0a1cc-3a39-44fe-b739-9b7fa5b867ea 50114-9002 HUMAN PRESCRIPTION DRUG BHI Uri-Control RX APIS MELLIFERA. SILVER NITRATE, ATROPA BELLADONNA, LYTTA VESICATORIA, CAUSTICUM, EQUISETUM HYEMALE, PETROSELINUM CRISPUM, PULSATILLA VULGARIS, SMILAX REGELII ROOT, and TURPENTINE OIL TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC MediNatura Inc APIS MELLIFERA; SILVER NITRATE; ATROPA BELLADONNA; LYTTA VESICATORIA; CAUSTICUM; EQUISETUM HYEMALE; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SMILAX REGELII ROOT; TURPENTINE OIL 6; 6; 4; 6; 8; 6; 8; 6; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20191231 50114-9482_68aacb15-faba-4541-b3a0-06dc9766ab8a 50114-9482 HUMAN PRESCRIPTION DRUG Traumeel Rx ACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM and COMFREY ROOT OINTMENT TOPICAL 20160428 UNAPPROVED HOMEOPATHIC MediNatura Inc ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; HYPERICUM PERFORATUM; MERCURIUS SOLUBILIS; ACHILLEA MILLEFOLIUM; COMFREY ROOT 1; 3; 1; 1; 1; 1; 1; 1; 1; 6; 6; 6; 1; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g E 20171231 50114-9483_7d9dd108-5826-47d3-a2f0-dc5c0d497e6c 50114-9483 HUMAN PRESCRIPTION DRUG Traumeel Rx Traumeel Rx TABLET ORAL 20160701 UNAPPROVED HOMEOPATHIC MediNatura Inc ATROPA BELLADONNA; ECHINACEA, UNSPECIFIED; ACHILLEA MILLEFOLIUM; ARNICA MONTANA ROOT; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; COMFREY ROOT; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA LEAF; ECHINACEA PURPUREA; MERCURIUS SOLUBILIS; ACONITUM NAPELLUS ROOT; SYMPHYTUM OFFICINALE WHOLE 4; 2; 3; 2; 2; 2; 2; 8; 3; 2; 2; 8; 3; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 50125-001_d7e65c45-74f4-45bc-bbba-3f30166aad4f 50125-001 HUMAN OTC DRUG Medessence Plus Homeopathic Nail Thuja Occidentalis, Antimonium Crudum SOLUTION TOPICAL 20090501 UNAPPROVED HOMEOPATHIC Deep Cover Systems LLC THUJA OCCIDENTALIS TWIG; ANTIMONY TRISULFIDE; DIOSCOREA VILLOSA EXTRACT; GRAPHITE; SILICON DIOXIDE; SODIUM BORATE; CINNAMON 10; 10; 10; 10; 10; 10; 10 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL E 20171231 50130-316_5089eb28-fb10-4013-b683-e625d14c386b 50130-316 HUMAN OTC DRUG BIO-ICE MENTHOL, CAMPHOR GEL TOPICAL 20130101 OTC MONOGRAPH FINAL part341 Electrostim Medical Services Inc. d/b/a EMSI MENTHOL; CAMPHOR (SYNTHETIC) 5.4; .48 g/100mL; g/100mL E 20171231 50136-555_906cda44-1f0f-41fd-94d2-7ee341c85dda 50136-555 HUMAN OTC DRUG Hy5 Alcohol Free Benzalkonium Chloride LIQUID TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 MGS Brands, Inc. BENZALKONIUM CHLORIDE .13 L/100L N 20181231 50145-222_62bb10cd-4e99-4e93-a7f5-9dabf692a2d6 50145-222 HUMAN OTC DRUG Hipoglos Zinc Oxide and Lanolin OINTMENT TOPICAL 20101103 OTC MONOGRAPH NOT FINAL part348 Laboratorios Andromaco S.A. ZINC OXIDE; LANOLIN 15; 15 g/100g; g/100g E 20171231 50148-052_4fd65ef8-b6d2-60f7-e054-00144ff8d46c 50148-052 HUMAN OTC DRUG Naturlax Ginger Peach Flavored Psyllium Fiber Naturlax Ginger Peach Flavored Psyllium Fiber POWDER ORAL 20170520 OTC MONOGRAPH NOT FINAL part334 Seelect Inc PSYLLIUM HUSK 15 g/99g N 20181231 50153-110_28d7cf3b-d58a-42af-bfc1-521cd57c53c4 50153-110 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130326 UNAPPROVED MEDICAL GAS Island Equipment Company OXYGEN 99 L/100L E 20171231 50154-000_8bead96a-1dd8-4f9f-b710-2da783a31169 50154-000 HUMAN OTC DRUG Le Vital Wake Me Up ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 g/100g E 20171231 50154-001_9ef583f2-e65e-482f-8328-d06042d4d671 50154-001 HUMAN OTC DRUG Le Vital Hidden Passion ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 g/100g E 20171231 50154-002_afd773a2-479d-40ef-a9dc-ce84cc223b47 50154-002 HUMAN OTC DRUG Le Vital Dreamy Glow ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 g/100g E 20171231 50154-003_47377e80-20dd-41c0-aa6c-c377b0d10d73 50154-003 HUMAN OTC DRUG Le Vital Blossom Delight ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 g/100g E 20171231 50154-0030_575e8741-8aec-4c17-92b6-e7ba43d0fc46 50154-0030 HUMAN OTC DRUG Mellow Instant Hand Sanitizer With Aloe and Vitamin E Ethyl Alcohol GEL TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333A Lantern Enterprises Ltd. ALCOHOL 62 mL/100mL E 20171231 50154-004_d46cba71-d5f2-4ab8-944b-db98b8377dda 50154-004 HUMAN OTC DRUG Le Vital Berry Kissed ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 g/100g E 20171231 50154-0040_08259087-acd2-49ab-a4a6-d9121d545481 50154-0040 HUMAN OTC DRUG Mellow Instant Hand Sanitizer Original Ethyl Alcohol GEL TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Lantern Enterprises Ltd. ALCOHOL 62 mL/100mL N 20181231 50154-005_330d573d-a034-10f8-e054-00144ff8d46c 50154-005 HUMAN OTC DRUG Le Vital Japanese Cherry Blossom ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 g/100g E 20171231 50154-006_e8fb1a39-b1ba-4b7f-a768-9662e270f73b 50154-006 HUMAN OTC DRUG Le Vital Midnight Rush ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 g/100g E 20171231 50154-007_3208323d-d4e3-36ae-e054-00144ff8d46c 50154-007 HUMAN OTC DRUG Le Vital Moon to Light ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 g/100g E 20171231 50154-007_385bb863-6230-43f6-980e-47ec100cde06 50154-007 HUMAN OTC DRUG Le Vital Moon to Light ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 g/100g E 20171231 50154-008_3208323d-d528-36ae-e054-00144ff8d46c 50154-008 HUMAN OTC DRUG Le Vital Sweet Pea ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 g/100g E 20171231 50154-008_b474b8f9-d615-4534-81ec-5e9cb21a487b 50154-008 HUMAN OTC DRUG Le Vital Sweet Pea ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 g/100g E 20171231 50154-009_05d047eb-b9ed-42f9-84ba-1471904ea389 50154-009 HUMAN OTC DRUG Le Vital Vanilla Heaven ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 g/100g E 20171231 50154-010_5c8b8314-178c-7d75-e053-2a91aa0ae19b 50154-010 HUMAN OTC DRUG SmartCare Shopkins ethyl alcohol GEL TOPICAL 20171027 OTC MONOGRAPH NOT FINAL part333E Lantern Enterprises Ltd. ALCOHOL 62 mL/100mL N 20181231 50154-011_32c0fcf5-a016-6dc7-e054-00144ff88e88 50154-011 HUMAN OTC DRUG Daily Moisturizing with Colloidal Oats CETYL ALCOHOL 0.80% LOTION TOPICAL 20160513 UNAPPROVED DRUG OTHER Lantern Enterprises Ltd. CETYL ALCOHOL 80 mg/100mL E 20171231 50154-012_32c041a6-afee-461b-e054-00144ff88e88 50154-012 HUMAN OTC DRUG All Day Skin Relief with Colloidal Oats CETYL ALCOHOL LOTION TOPICAL 20160513 UNAPPROVED DRUG OTHER Lantern Enterprises Ltd. CETYL ALCOHOL 80 mg/100mL E 20171231 50154-021_3a2782b7-25df-4208-9e14-ee84839adc7b 50154-021 HUMAN OTC DRUG MELLOW HAND SANITIZER (ALOE AND VITAMIN E) ALCOHOL GEL TOPICAL 20170616 OTC MONOGRAPH NOT FINAL part333A Lantern Enterprises Ltd. ALCOHOL 62 mL/100mL N 20181231 50154-022_4b292d5b-79ed-4b0e-8254-a75b2eba235b 50154-022 HUMAN OTC DRUG MELLOW HAND SANITIZER (ORIGINAL) WITH MOISTURIZER AND VITAMIN E ALCOHOL GEL TOPICAL 20170616 OTC MONOGRAPH NOT FINAL part333A Lantern Enterprises Ltd. ALCOHOL 62 mL/100mL N 20181231 50154-1050_270e8603-618f-495c-a9f4-b124097c4180 50154-1050 HUMAN OTC DRUG Instant Hand Sanitizer Original With Moisturizer and Vitamin E ALCOHOL SPRAY TOPICAL 20100506 OTC MONOGRAPH FINAL part333 Lantern Enterprises Ltd ALCOHOL 62 mL/100mL N 20181231 50154-1060_2af6053a-5a4e-4869-9a32-1938fa38ae53 50154-1060 HUMAN OTC DRUG Instant Hand Sanitizer With Aloe and Vitamin E ALCOHOL SPRAY TOPICAL 20100506 OTC MONOGRAPH FINAL part333 Lantern Enterprises Ltd ALCOHOL 62 mL/100mL E 20171231 50154-4000_54628be5-806d-4b32-84de-752942892b5d 50154-4000 HUMAN OTC DRUG Instant Hand Sanitizer With Shea Butter Beads ALCOHOL GEL TOPICAL 20100527 OTC MONOGRAPH FINAL part333 Lantern Enterprises Ltd ALCOHOL 62 mL/100mL E 20171231 50154-5000_d0abeff8-2675-46e9-b244-155e75d7ba96 50154-5000 HUMAN OTC DRUG Instant Hand Sanitizer Unscented With Moisturizer and Vitamin E ALCOHOL GEL TOPICAL 20100527 OTC MONOGRAPH FINAL part333 Lantern Enterprises Ltd ALCOHOL 62 mL/100mL E 20171231 50157-100_0812c2b7-a905-3252-e054-00144ff88e88 50157-100 HUMAN OTC DRUG Visibly Clean Hand Sanitizer ALCOHOL SOLUTION TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E Brands International ALCOHOL 62 mL/100mL E 20171231 50157-101_34100d44-e309-6fc0-e054-00144ff8d46c 50157-101 HUMAN OTC DRUG SpaSoap Liquid Antibacterial TRICLOSAN SOLUTION TOPICAL 20150124 OTC MONOGRAPH NOT FINAL part333A Brands International TRICLOSAN 1.15 mg/mL E 20171231 50157-102_34100d44-e30b-6fc0-e054-00144ff8d46c 50157-102 HUMAN OTC DRUG SpaSoap Liquid Antibacterial 2X Ultra TRICLOSAN SOLUTION TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Brands International TRICLOSAN 1.15 mg/mL E 20171231 50157-103_2a32ad22-ea77-128e-e054-00144ff88e88 50157-103 HUMAN OTC DRUG Gingerbread Antibacterial Hand Sanitizer GEL TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Brands International ALCOHOL 620 mL/1000mL E 20171231 50157-104_21242e8d-50c4-32cc-e054-00144ff8d46c 50157-104 HUMAN OTC DRUG FROSTED SUGAR COOKIE Antibacterial Hand Sanitizer GEL TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Brands International ALCOHOL 620 mL/1000mL E 20171231 50157-105_14479bd7-1d11-551f-e054-00144ff8d46c 50157-105 HUMAN OTC DRUG Hibiscus Coconut Hand Sanitizer ALCOHOL SOLUTION TOPICAL 20150420 OTC MONOGRAPH NOT FINAL part333E Brands International ALCOHOL 62 mL/100mL E 20171231 50157-106_14479bd7-1d03-551f-e054-00144ff8d46c 50157-106 HUMAN OTC DRUG Hawaiian Passion Hand Sanitizer ALCOHOL SOLUTION TOPICAL 20150420 OTC MONOGRAPH NOT FINAL part333E Brands International ALCOHOL 62 mL/100mL E 20171231 50157-107_1446e6c4-d9f1-2b88-e054-00144ff8d46c 50157-107 HUMAN OTC DRUG Mango Madness Hand Sanitizer ALCOHOL SOLUTION TOPICAL 20150420 OTC MONOGRAPH NOT FINAL part333E Brands International ALCOHOL 62 mL/100mL E 20171231 50157-108_c3164b9a-fd69-46fe-a2b8-4d7edfe00561 50157-108 HUMAN OTC DRUG AEROSCENT Milk and Honey Antibacterial Moisturizing TRICLOSAN SOLUTION TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part333E Brands International TRICLOSAN 1.15 mg/mL E 20171231 50157-109_2123aca0-706f-1d8b-e054-00144ff8d46c 50157-109 HUMAN OTC DRUG SUGAR PLUM ANTIBACTERIAL HAND SANITIZER GEL TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Brands International ALCOHOL 620 mL/1000mL E 20171231 50157-110_3e109713-e23a-6ce9-e054-00144ff8d46c 50157-110 HUMAN OTC DRUG TWISTED PEPPERMINT ANTIBACTERIAL HAND SANITIZER GEL TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Brands International ALCOHOL 620 mL/1000mL E 20171231 50157-111_34100d44-e30a-6fc0-e054-00144ff8d46c 50157-111 HUMAN OTC DRUG SpaSoap Liquid Antibacterial TRICLOSAN SOLUTION TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Brands International TRICLOSAN 1.15 mg/mL E 20171231 50157-112_213f5624-0de6-5992-e054-00144ff88e88 50157-112 HUMAN OTC DRUG CRANBERRY CAKE ANTIBACTERIAL HAND SANITIZER GEL TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Brands International ALCOHOL 620 mL/1000mL E 20171231 50157-113_2ed2be6b-c6f2-409c-e054-00144ff88e88 50157-113 HUMAN OTC DRUG Vanilla Cream Antibacterial Gel Hand Wash LIQUID TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Brands International TRICLOSAN 1.15 mg/mL E 20171231 50157-114_2346dcb3-f1ba-6ba8-e054-00144ff8d46c 50157-114 HUMAN OTC DRUG SWIRLING LOLLIPOP Antibacterial Hand Sanitizer Gel GEL TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part333A Brands International Corp ALCOHOL 620 mL/1000mL E 20171231 50157-115_3f8b6baa-4897-376c-e054-00144ff8d46c 50157-115 HUMAN OTC DRUG Japanese Cherry Blossom Antibacterial Hand Sanitizer Gel GEL TOPICAL 20150110 OTC MONOGRAPH NOT FINAL part333A Brands International Corp ALCOHOL 620 mL/1000mL E 20171231 50157-116_3f8bfbc5-c5c0-1523-e054-00144ff8d46c 50157-116 HUMAN OTC DRUG Bubble Gum Antibacterial Hand Sanitizer Gel GEL TOPICAL 20150110 OTC MONOGRAPH NOT FINAL part333A Brands Internation Corp ALCOHOL 620 mL/1000mL E 20171231 50157-117_3f8ed4b8-0b01-2ebb-e054-00144ff8d46c 50157-117 HUMAN OTC DRUG Island Cotton Antibacterial Hand Sanitizer GEL TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part333A Brands International Corp ALCOHOL 620 mL/1000mL E 20171231 50157-118_2ae120dd-a1a8-0a21-e054-00144ff8d46c 50157-118 HUMAN OTC DRUG Pear Blossom Antibacterial Gel Hand Wash Triclosan LIQUID TOPICAL 20160203 OTC MONOGRAPH NOT FINAL part333A Brands International TRICLOSAN 1.15 mg/mL E 20171231 50157-119_34100d44-e308-6fc0-e054-00144ff8d46c 50157-119 HUMAN OTC DRUG Triclosan Antibacterial Liquid Soap Refill SOAP TOPICAL 20160203 OTC MONOGRAPH NOT FINAL part333A Brands International TRICLOSAN 1.15 mg/mL E 20171231 50157-200_d9f0b9a3-32ba-4bdd-bf90-00d22099dfb7 50157-200 HUMAN OTC DRUG secure chloroxylenol AEROSOL, FOAM TOPICAL 20110424 OTC MONOGRAPH NOT FINAL part333A Brands International CHLOROXYLENOL .5 mL/100mL E 20171231 50157-201_3f8e32da-7ccd-605a-e054-00144ff88e88 50157-201 HUMAN OTC DRUG Antibacterial Triclosan LIQUID TOPICAL 20160506 OTC MONOGRAPH NOT FINAL part333A Brands International Corp TRICLOSAN 1.15 mg/100mL E 20171231 50157-202_3f90a5ae-8775-1312-e054-00144ff8d46c 50157-202 HUMAN OTC DRUG Antibacterial Triclosan LIQUID TOPICAL 20160506 OTC MONOGRAPH NOT FINAL part333A Brands International Corp TRICLOSAN 1.15 mg/mL E 20171231 50157-203_3f90a5ae-878c-1312-e054-00144ff8d46c 50157-203 HUMAN OTC DRUG Antibacterial Triclosan LIQUID TOPICAL 20160506 OTC MONOGRAPH NOT FINAL part333A Brands International Corp TRICLOSAN 1.15 mg/100mL E 20171231 50157-204_3f9465db-1c02-0517-e054-00144ff8d46c 50157-204 HUMAN OTC DRUG Blackhead clearing scrub Salicyclic Acid RINSE TOPICAL 20161001 OTC MONOGRAPH FINAL part358H Brands International Corp SALICYLIC ACID .2 mg/100mg E 20171231 50157-206_3e00ec76-8601-1091-e054-00144ff88e88 50157-206 HUMAN OTC DRUG Benzalkonium Chloride Antibacterial Hand Soap Refill LIQUID TOPICAL 20161003 OTC MONOGRAPH NOT FINAL part333A Brands International Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 50157-207_53c13b0c-9c2d-49f1-e054-00144ff88e88 50157-207 HUMAN OTC DRUG Antibacterial Benzalkonium Chloride LIQUID TOPICAL 20170707 OTC MONOGRAPH NOT FINAL part333A Brands International Corporation BENZALKONIUM CHLORIDE 1.3 mg/1000mL N 20181231 50164-0001_d2dfc402-4538-43ee-b90b-e986c89aa585 50164-0001 HUMAN OTC DRUG Trauma Free Drops Symphytum officinale, Bellis perennis, Hypericum perforatum, Magnesia phosphorica, Ruta graveolens, Arnica montana, LIQUID ORAL 20120626 20200817 UNAPPROVED HOMEOPATHIC Sago Natural Products COMFREY ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA 3; 12; 12; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50164-0002_0d71e450-0df2-45de-853e-2df95a4fd531 50164-0002 HUMAN OTC DRUG Trauma Free Symphytum officinale, Bellis perennis, Hypericum perforatum, Magnesia Phosphorica, Ruta graveolens, Arnica montana, LIQUID ORAL 20120621 20200903 UNAPPROVED HOMEOPATHIC Sago Natural Products COMFREY ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA 3; 12; 12; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50164-0003_c3ea0e7d-d5f0-47e2-b8ca-f934aa37a903 50164-0003 HUMAN OTC DRUG Trauma Free Symphytum Officinale, Bellis Perennis, Hypericum Perforatum, Magnesia Phosphorica, Ruta Graveolens, Arnica Montana LIQUID ORAL 20160624 UNAPPROVED HOMEOPATHIC Sago Natural Products COMFREY ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA 6; 12; 12; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50164-0004_6b7e4683-5d6e-42f3-be8d-369df0e3561c 50164-0004 HUMAN OTC DRUG Trauma Free Symphytum Officinale, Bellis Perennis, Hypericum Perforatum, Magnesia Phosphorica, Ruta Graveolens, Arnica Montana LIQUID ORAL 20160624 UNAPPROVED HOMEOPATHIC Sago Natural Products COMFREY ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA 6; 12; 12; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50167-7100_738fc1b8-bfb4-45d7-882a-3d4f90f3d798 50167-7100 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol GEL TOPICAL 20091202 OTC MONOGRAPH FINAL part333 Germs Travel, LLC ALCOHOL .6 g/1 N 20181231 50169-0001_8024fadf-746c-44c5-baa4-57eadbd5e2c8 50169-0001 HUMAN OTC DRUG Type 4 Noise Regular Causticum, Chininum Sulphuricum, Cinchona Officinalis, Pulsatilla, Thiosinaminum TABLET, ORALLY DISINTEGRATING ORAL 20130402 UNAPPROVED HOMEOPATHIC T Gone Remedies CAUSTICUM; QUININE SULFATE; CINCHONA OFFICINALIS BARK; PULSATILLA VULGARIS; ALLYLTHIOUREA 3; 3; 6; 6; 6 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 50169-0002_0cbdfc87-59a1-477a-b0ce-5f3ad0a20d69 50169-0002 HUMAN OTC DRUG Type 3 Sinus Regular Silicea, Hydrastis Canadensis, Kali Bichromicum, Calcarea Carbonica TABLET, ORALLY DISINTEGRATING ORAL 20130403 UNAPPROVED HOMEOPATHIC T Gone Remedies SILICON DIOXIDE; GOLDENSEAL; POTASSIUM DICHROMATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE 6; 6; 6; 12 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 50169-0003_346a698e-1eee-4020-a06d-50fb93b1ccf2 50169-0003 HUMAN OTC DRUG Type 4 Noise Max Causticum, Chininum Sulphuricum, Cinchona Officinalis, Pulsatilla, Thiosinaminum TABLET, ORALLY DISINTEGRATING ORAL 20130410 UNAPPROVED HOMEOPATHIC T Gone Remedies CAUSTICUM; QUININE SULFATE; CINCHONA OFFICINALIS BARK; PULSATILLA VULGARIS; ALLYLTHIOUREA 200; 200; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_X]/mg N 20181231 50169-0004_8f509f40-c521-4561-b688-ae3e280cd999 50169-0004 HUMAN OTC DRUG Type 7 Stress Anxiety Regular Kali Phosphoricum, Phosphoricum Acidum, Sepia, Sulphur, Calcarea Carbonica, Silicea TABLET, ORALLY DISINTEGRATING ORAL 20130424 UNAPPROVED HOMEOPATHIC T-Gone Remedies POTASSIUM PHOSPHATE, DIBASIC; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE 3; 6; 6; 6; 12; 12 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 50169-0005_2e602966-60ec-4c61-974a-a024e535f902 50169-0005 HUMAN OTC DRUG Type 3 Sinus Max Calcarea Carbonica, Hydrastis Candensis, Kali Bichromicum, Silicea TABLET, ORALLY DISINTEGRATING ORAL 20130905 UNAPPROVED DRUG OTHER TGone Remedies Ltd OYSTER SHELL CALCIUM CARBONATE, CRUDE; GOLDENSEAL; POTASSIUM DICHROMATE; SILICON DIOXIDE 200; 200; 200; 200 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 50169-0006_a0066455-bb88-4b09-8380-0a6f92a6ee58 50169-0006 HUMAN OTC DRUG Type 11 Dizziness Max Belladonna, Calcarea carbonica, Phosphorus, Pulsatilla (Vulgaris), Silicea, TABLET ORAL 20140617 UNAPPROVED HOMEOPATHIC T-Gone Remedies ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE 200; 200; 200; 200; 200 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 50169-0007_912b886b-2c65-40e6-94c0-1b1eb3b5d9fa 50169-0007 HUMAN OTC DRUG Type 7 Stress Anxiety Max Calcarea Carbonica, Kali Phosphoricum, Phosphoricum Acidum, Sepia, Silicea, Sulphur TABLET ORAL 20140708 UNAPPROVED HOMEOPATHIC TGone Remedies Ltd OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM PHOSPHATE, DIBASIC; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 200; 200; 200; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg N 20181231 50181-0001_3b360f48-fcee-4a73-a81b-845592866e93 50181-0001 HUMAN OTC DRUG MBM 11 Thyroid Adrenal Iodium, Phytolacca Decandra, Adrenalinum, Adrenocorticotrophin, Thyroidinum, Belladonna, Phosphorus, Calcarea Carbonica, Natrum Muriaticum, Nux Moschata, Stramonium, Argentum Nitricum LIQUID ORAL 20120803 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. IODINE; PHYTOLACCA AMERICANA ROOT; EPINEPHRINE; CORTICOTROPIN; SUS SCROFA THYROID; ATROPA BELLADONNA; PHOSPHORUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; NUTMEG; DATURA STRAMONIUM; SILVER NITRATE 3; 3; 3; 5; 5; 34; 55; 89; 89; 89; 89; 233 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0002_d3c96c13-0570-4eb9-9e27-04340c2a57f2 50181-0002 HUMAN OTC DRUG Thyro T3 Rescue Spongia Tosta, Iodium, Fucus Vesiculosus, Belladonna, Adenosinum Triphosphoricum Dinatrum, Parathyroid (Bovinum), Selenium Metallicum, Thyroidinum (Suis), Hepar Bovine, Hypothalamus (Suis), Kidney (Suis), Pituitaria Glandula (Suis), Thymus (Suis), Levothyroxinum, Triiodothyronine LIQUID ORAL 20120815 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education SPONGIA OFFICINALIS SKELETON, ROASTED; IODINE; FUCUS VESICULOSUS; ATROPA BELLADONNA; ADENOSINE TRIPHOSPHATE; BOS TAURUS PARATHYROID GLAND; SELENIUM; THYROID, PORCINE; BEEF LIVER; SUS SCROFA HYPOTHALAMUS; PORK KIDNEY; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; LEVOTHYROXINE; LIOTHYRONINE 3; 3; 3; 4; 6; 8; 8; 8; 8; 8; 8; 8; 8; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_Q]/mL N 20181231 50181-0003_b5b01858-7a92-4fea-8a60-63c467841565 50181-0003 HUMAN OTC DRUG MBM 6 Liver Chelidonium Majus, Hepar Suis, Cholesterinum, Lycopodium Clavatum, Tarentula Hispana, Arsenicum Album, Belladonna LIQUID ORAL 20120915 UNAPPROVED HOMEOPATHIC Wellness Center CHELIDONIUM MAJUS; PORK LIVER; CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; ARSENIC TRIOXIDE; ATROPA BELLADONNA FRUITING TOP 3; 3; 21; 144; 144; 233; 233 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0004_20fa7138-99b8-45cf-8381-e326b2f244e5 50181-0004 HUMAN OTC DRUG Endopure Testos for Men DNA, Hypothalamus (suis), RNA, Cortisol, Glandula suprarenalis suis, Pituitary (suis), Prostate (suis), Testosterone, Chelidonium majus, Sabal serrulata, Thuja occidentalis, LIQUID ORAL 20121011 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. HERRING SPERM DNA; SUS SCROFA HYPOTHALAMUS; SACCHAROMYCES CEREVISIAE RNA; HYDROCORTISONE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; TESTOSTERONE; CHELIDONIUM MAJUS; SAW PALMETTO; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6; 6; 6; 6; 6; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0005_2c35ec18-eeb2-49ef-83c7-a2a8522268e0 50181-0005 HUMAN OTC DRUG Endopure Testos For Women DNA, Hypothalamus suis, RNA, Sabal Serrulata, Hydocortisone, Glandula Suprarenalis Suis, Pituitary suis, Testosterone, Chelidonium Majus, Thuja Occidentalis, LIQUID ORAL 20121011 UNAPPROVED HOMEOPATHIC The Wellness Center HERRING SPERM DNA; SUS SCROFA HYPOTHALAMUS; SACCHAROMYCES CEREVISIAE RNA; SAW PALMETTO; HYDROCORTISONE; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; TESTOSTERONE; CHELIDONIUM MAJUS; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6; 6; 6; 6; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0007_ab4b31ab-828b-40e8-a51c-1657cbf05fd1 50181-0007 HUMAN OTC DRUG Lymph Detox Plus Apis mellifica, Arnica montana, Berberis vulgaris, Gelsemium sempervirens, Hydrastis canadensis, Phytolacca decandra, Solidago virgaurea, LIQUID ORAL 20121012 UNAPPROVED HOMEOPATHIC The Wellness Center APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; CHELIDONIUM MAJUS; TOXICODENDRON PUBESCENS LEAF; LACHESIS MUTA VENOM 3; 3; 3; 3; 3; 3; 3; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50181-0008_ab5ee37a-9d51-47f9-9ef7-3e2e8b176df1 50181-0008 HUMAN OTC DRUG MBM 2 Gallbladder Fel Tauri, Chionanthus Virginica, Nux Vomica, Arsenicum Album, Plantinum Metallicum LIQUID ORAL 20121024 UNAPPROVED HOMEOPATHIC The Wellness Center BOS TAURUS BILE; CHIONANTHUS VIRGINICUS BARK; STRYCHNOS NUX-VOMICA SEED; ARSENIC TRIOXIDE; PLATINUM 3; 34; 34; 233; 233 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50181-0009_be558b38-b02d-4359-923c-33d8c3f5a4be 50181-0009 HUMAN OTC DRUG 11 Thyroid Adrenal Kodium, Phytocalla decandra, Adrenalinum, Adrenocorticotrophin, Belladonna, Thyroidinum (suis), Natrum muriaticum, Argentum nitricum, Calcarea carbonica, Nux moschata, Phosphorus, LIQUID ORAL 20121012 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. IODINE; PHYTOLACCA AMERICANA ROOT; EPINEPHRINE; CORTICOTROPIN; SUS SCROFA THYROID; SODIUM CHLORIDE; SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; NUTMEG; PHOSPHORUS 3; 3; 6; 6; 30; 200; 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50181-0010_161e954d-39c5-461c-9912-74c9d3c55e23 50181-0010 HUMAN OTC DRUG MBM 3 Heart-Shock Phytolacca Decandra, Spongia Tosta, Crocus Sativus, Coffea Cruda, Aurum Metallicum LIQUID ORAL 20121024 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education PHYTOLACCA AMERICANA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; SAFFRON; ARABICA COFFEE BEAN; GOLD 3; 3; 34; 34; 34 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0011_60fc34b5-2af2-47d9-b86d-5c9e406ffb1b 50181-0011 HUMAN OTC DRUG MBM 10 Stomach Condurango, Stomach (Suis), Nux Vomica, Aurum Metallicum, Antimonium Crudum, Hyoscyamus Niger, Sulphur LIQUID ORAL 20130913 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. MARSDENIA CONDURANGO BARK; SUS SCROFA STOMACH; STRYCHNOS NUX-VOMICA SEED; GOLD; ANTIMONY TRISULFIDE; HYOSCYAMUS NIGER; SULFUR 3; 5; 89; 144; 233; 233; 233 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0012_1299735b-1f5f-47df-b92a-3d336ba00244 50181-0012 HUMAN OTC DRUG 4 Kidney Solidago Virgaurea, Berberis Vulgaris, Aconitum Napellus, Argentum Nitricum, Arnica Montana, Nitricum Acidum LIQUID ORAL 20121012 UNAPPROVED HOMEOPATHIC The Wellness Center SOLIDAGO VIRGAUREA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; ACONITUM NAPELLUS; ARNICA MONTANA; SILVER NITRATE; NITRIC ACID 3; 30; 1; 1; 1; 1 [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 50181-0013_9cb2784c-5ab2-49fb-bed5-c18871c6270d 50181-0013 HUMAN OTC DRUG 2 Gallbladder Fel Tauri, Chionanthus Virginica, Arsenicum Album, Nux Vomica, Platinum Metallicum LIQUID ORAL 20121024 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. BOS TAURUS BILE; CHIONANTHUS VIRGINICUS BARK; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; PLATINUM 3; 34; 1; 1; 1 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 50181-0014_c8cb0d0d-e9cc-4693-810d-5e24caf782cc 50181-0014 HUMAN OTC DRUG Biotox Para Cochlearia Armoracia, Toxoplasma Gondii, Vibrio Cholerae, Candida Albicans, Trichinella Spiralis LIQUID ORAL 20130607 UNAPPROVED HOMEOPATHIC The Wellness Center HORSERADISH; TOXOPLASMA GONDII; VIBRIO CHOLERAE; CANDIDA ALBICANS; TRICHINELLA SPIRALIS; TARAXACUM OFFICINALE; PLASMODIUM MALARIAE; TRICHOPHYTON RUBRUM 3; 12; 30; 30; 30; 8; 12; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0015_6194b870-2f64-4072-af48-7d2f3aae673e 50181-0015 HUMAN PRESCRIPTION DRUG 5 Large Intestine Hydrastis Canadensis, Senna, Agaricus Muscarius, Arnica Montana, Baptisia Tinctoria, Cuprum Metallicum LIQUID ORAL 20121026 UNAPPROVED HOMEOPATHIC The Wellness Center SENNA LEAF; GOLDENSEAL; ARNICA MONTANA; BAPTISIA TINCTORIA; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; COPPER; NITRIC ACID 3; 3; 1; 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] N 20181231 50181-0016_ba6d5b5d-a93a-4465-a44f-68d04fa8475e 50181-0016 HUMAN OTC DRUG MBM 5 Large Intestine Hydrastis Canadensis, Large Intestine, Senna, Cuprum Metallicum, Nitricum Acidum, Agaricus Muscarius, Arnica Montanna LIQUID ORAL 20121126 UNAPPROVED HOMEOPATHIC The Wellness Center GOLDENSEAL; SUS SCROFA LARGE INTESTINE; SENNA LEAF; COPPER; NITRIC ACID; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT 3; 3; 3; 89; 89; 144; 144; 144 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0017_48e59b69-cb61-443d-b1a2-fd0709d0d26d 50181-0017 HUMAN OTC DRUG Slim Lycopodium Clavatum, Phytolacca Decandra, Abies Canadensis, Ammonium Bromatum, Ammonium Muriaticum, Pulsatilla LIQUID ORAL 20121130 UNAPPROVED HOMEOPATHIC The Wellness Center LYCOPODIUM CLAVATUM SPORE; PHYTOLACCA AMERICANA ROOT; TSUGA CANADENSIS BARK; AMMONIUM BROMIDE; AMMONIUM CHLORIDE; PULSATILLA VULGARIS; POTASSIUM DICHROMATE; AMMONIUM CARBONATE; FUCUS VESICULOSUS; CAPSICUM; SILVER NITRATE; SILICON DIOXIDE; BOS TAURUS ADRENAL GLAND; CALCIUM ARSENATE; IRON; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; POTASSIUM CARBONATE; SEMECARPUS ANACARDIUM JUICE; IODINE; SUS SCROFA THYROID; LEPTIN HUMAN 2; 3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 8; 8; 12; 12; 12; 12; 12; 30; 4; 4; 5; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0018_45634cb0-8d75-4ac5-90aa-31cd8a273c55 50181-0018 HUMAN OTC DRUG MBM 13 Female Oxytocin, Phytolacca Decandra, Pituitary (Suis), Scrophularia Nodosa, Hypothalamus (Suis), Calcarea Carbonica, Cumicifuga Racemosa, Lilium Tigrinum, Sulphur, Causticum, Graphites, Kali Phosphoricum LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education OXYTOCIN; PHYTOLACCA AMERICANA ROOT; SUS SCROFA PITUITARY GLAND; SCROPHULARIA NODOSA; SUS SCROFA HYPOTHALAMUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; BLACK COHOSH; LILIUM LANCIFOLIUM WHOLE FLOWERING; SULFUR; CAUSTICUM; GRAPHITE; POTASSIUM PHOSPHATE, DIBASIC 6; 3; 3; 3; 5; 89; 89; 89; 89; 144; 144; 233 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0019_ec58a298-7df5-4570-a561-fbafe36b98c3 50181-0019 HUMAN OTC DRUG MBM 12 Male Oxytocin, Chimaphila Umbellata, Pituitary (Suis), Uva Ursi, Orchitinum (Suis), Prostate (Suis), Sarsaparilla, Gelsemium Sempervirens, Zincum Metallicum, Kali Phosphoricum, Phosphoricum Acidum LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education OXYTOCIN; CHIMAPHILA UMBELLATA; SUS SCROFA PITUITARY GLAND; ARCTOSTAPHYLOS UVA-URSI LEAF; SUS SCROFA TESTICLE; SUS SCROFA PROSTATE; SARSAPARILLA; GELSEMIUM SEMPERVIRENS ROOT; ZINC; POTASSIUM PHOSPHATE, DIBASIC; PHOSPHORIC ACID 6; 3; 3; 5; 5; 8; 8; 34; 55; 144; 233 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0020_9e440d0f-b5a9-4466-860e-b6666a225ed8 50181-0020 HUMAN OTC DRUG 3 Heart Phytolacca Decandra, Spongia Tosta, Aurum Metallicum, Coffea Cruda, Crocus Sativus LIQUID ORAL 20121228 UNAPPROVED HOMEOPATHIC The Wellness Center for Research & Education PHYTOLACCA AMERICANA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; GOLD; ARABICA COFFEE BEAN; SAFFRON 3; 3; 30; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 50181-0021_e7ea6725-b393-4d0e-b142-f3aaa52461f6 50181-0021 HUMAN OTC DRUG MBM 4 Kidney Kidney (suis), Solidago virgaurea, Berberis vulgaris, Carcinosinum, Belladonna, Cicuta virosa, Nitricum acidum, Aconitum napellus, Argentum nitricum, Arnica montana, LIQUID ORAL 20130102 UNAPPROVED HOMEOPATHIC The Wellness Center PORK KIDNEY; SOLIDAGO VIRGAUREA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; HUMAN BREAST TUMOR CELL; ATROPA BELLADONNA WHOLE; CICUTA VIROSA ROOT; NITRIC ACID; ACONITUM NAPELLUS; SILVER NITRATE; ARNICA MONTANA 3; 3; 5; 8; 8; 84; 89; 144; 233; 233 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0022_1559c3b7-7cb0-4e9b-9485-a5b1f2c8deca 50181-0022 HUMAN OTC DRUG EndoPure Pro L Arginine, Pineal, Pituitary, Progesteronium, Belladonna, Chelidonium Majus, Dioscorea Villosa, Folliculinum LIQUID ORAL 20130108 UNAPPROVED HOMEOPATHIC The Wellness Center ARGININE; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; PROGESTERONE; ATROPA BELLADONNA WHOLE; CHELIDONIUM MAJUS; DIOSCOREA VILLOSA TUBER; ESTRONE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; LILIUM LANCIFOLIUM WHOLE FLOWERING; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SULFUR 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0023_5e239647-8b72-47cb-9471-bd5e28b211ce 50181-0023 HUMAN OTC DRUG EndoPure Estro Estriol, Estradiol, Folliculinum, Belladonna, Chelidonium Majus, Hydrocortisone, Glandula Suprarenalis Suis, Hypothalamus suis, Oophorinum suis, Pineal suis, Pituitary suis, Sanguinaria Canadensis, Lilium Tigrinum, Pulsatilla, Sepia, Sulphur LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education ESTRIOL; ESTRADIOL; ESTRONE; ATROPA BELLADONNA WHOLE; CHELIDONIUM MAJUS; HYDROCORTISONE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; SANGUINARIA CANADENSIS ROOT; LILIUM LANCIFOLIUM WHOLE FLOWERING; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SULFUR 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0024_19e6569c-1a3f-464f-9f2b-0e305475670f 50181-0024 HUMAN OTC DRUG MBM 8 Small Intestine Condurango, Intestine (Suis), Phytolacca Decandra, Aconitum Napellus, Aurum Metallicum, Sulphur, Hydrastis Canadensis, Mercurius Solubilis, Graphites, Pulsatilla LIQUID ORAL 20130405 UNAPPROVED HOMEOPATHIC The Wellness Center MARSDENIA CONDURANGO BARK; PORK INTESTINE; PHYTOLACCA AMERICANA ROOT; ACONITUM NAPELLUS; GOLD; SULFUR; GOLDENSEAL; MERCURIUS SOLUBILIS; GRAPHITE; PULSATILLA VULGARIS 3; 3; 3; 55; 55; 55; 89; 144; 233; 233 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0025_87dda463-afe6-4675-9347-af54ca5d4354 50181-0025 HUMAN OTC DRUG NEUROBALANCE PRO Adrenocorticotrophin, Gaba, Glutamic Acid, norepinephrine, Acetylcholine Chloride, Adrenalinum, L-Dopa, Serotonin, Thyroidinum (Suis) LIQUID ORAL 20130809 UNAPPROVED HOMEOPATHIC The Wellness Center for Reseach and Education, Inc. CORTICOTROPIN; .GAMMA.-AMINOBUTYRIC ACID; GLUTAMIC ACID; NOREPINEPHRINE; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; LEVODOPA; SEROTONIN; SUS SCROFA THYROID; SEMECARPUS ANACARDIUM JUICE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; DATURA STRAMONIUM 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0026_7e36db6b-9038-459d-b658-a1c4e35b55e4 50181-0026 HUMAN OTC DRUG 6 Liver Chelidonium Majus, Cholesterinum, Arsenicum Album, Belladonna, Lycopodium Clavatum, Tarentula Hispana LIQUID ORAL 20130809 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. CHELIDONIUM MAJUS; CHOLESTEROL; ARSENIC TRIOXIDE; ATROPA BELLADONNA; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA 3; 30; 1; 1; 1; 10 [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20191231 50181-0028_fa698cf8-35e9-4cfa-97bd-a24b2e58749c 50181-0028 HUMAN OTC DRUG BIOTOX VI Cochlearia Armoracia, Spleen (Bovine), Thymus Gland (Bovine), Influenzinum, Mycoplasma Pneumoniae, Cytomegalovirus, HPV, Coxsackie B1, Coxsackie B4, Pneumococcinum, Carcinosin LIQUID ORAL 20141208 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. HORSERADISH; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MYCOPLASMA PNEUMONIAE; HUMAN HERPESVIRUS 5; HUMAN PAPILLOMAVIRUS; HUMAN COXSACKIEVIRUS B1; HUMAN COXSACKIEVIRUS B4; STREPTOCOCCUS PNEUMONIAE; HUMAN BREAST TUMOR CELL 3; 8; 8; 10; 10; 12; 12; 12; 8; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0029_97a0956a-af2c-416f-95aa-752afa584118 50181-0029 HUMAN OTC DRUG 8 Small Intestine Condurango, Phytolacca Decandra, Aconitum Napellus, Aurum Metallicum, Graphites, Hydrastis Canadensis, Mercurius Vivus, Sulphur, Pulsatilla LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC The Wellness Center MARSDENIA CONDURANGO BARK; PHYTOLACCA AMERICANA ROOT; ACONITUM NAPELLUS; GOLD; GRAPHITE; GOLDENSEAL; MERCURY; SULFUR; PULSATILLA VULGARIS 3; 3; 1; 1; 1; 1; 1; 1; 10 [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 50181-0030_7804a88d-aa5d-4103-bc66-541a75fa8522 50181-0030 HUMAN OTC DRUG 12 Male Reproductive Chimaphila Umbellata, Pituitaria Glandula (Suis), Sabal Serrulata, Uva-Ursi, Gelsemium Sempervirens, Sarsaparilla (Smilax Regelii) LIQUID ORAL 20130904 UNAPPROVED HOMEOPATHIC The Wellness Center CHIMAPHILA UMBELLATA; SUS SCROFA PITUITARY GLAND; SAW PALMETTO; ARCTOSTAPHYLOS UVA-URSI LEAF; GELSEMIUM SEMPERVIRENS ROOT; SARSAPARILLA; POTASSIUM PHOSPHATE, DIBASIC; PHOSPHORIC ACID; ZINC 3; 3; 6; 6; 30; 30; 1; 1; 1 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 50181-0031_c3de0ab3-1e88-4a95-8ac7-0935c73d90f4 50181-0031 HUMAN OTC DRUG Mercury Plus Detox Glutathione, Reduced, Brain (Suis), Spinal Cord (Suis), Thuja Occidentalis, Dimercaptopropane Sulfonate, Mercurius Solubilis, Silver Amalgam LIQUID ORAL 20130905 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. GLUTATHIONE; PORK BRAIN; SUS SCROFA SPINAL CORD; THUJA OCCIDENTALIS LEAF; UNITHIOL; MERCURIUS SOLUBILIS; SILVER; TIN; COPPER; MERCURY; THIMEROSAL 6; 6; 6; 6; 8; 8; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0032_fe7e5870-e01d-4237-849e-228f04a3cbc0 50181-0032 HUMAN OTC DRUG MBM 9 SPLEEN/PANCREAS Ceanothus americanus, Senna, Pancreas Suis, Spleen, Chionanthus virginica, Cinchona officinalis, Sepia, Arsenicum album, Lycopodium clavatum LIQUID ORAL 20131031 UNAPPROVED HOMEOPATHIC The Wellness Center CEANOTHUS AMERICANUS LEAF; SENNA LEAF; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; SEPIA OFFICINALIS JUICE; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE 3; 3; 5; 5; 34; 89; 144; 233; 233 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0033_c47c37a1-7daa-4aac-8ffd-24d05875db76 50181-0033 HUMAN OTC DRUG MBM 1 BLADDER Berberis Vulgaris, Bladder, Thuja Occidentalis, Byronia, Hepar Sulphuris Calcareum, Pulsatilla, Staphysagria, Apis Mellifica, Baryta Carbonica LIQUID ORAL 20140103 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. BERBERIS VULGARIS ROOT BARK; SUS SCROFA URINARY BLADDER; THUJA OCCIDENTALIS LEAF; BRYONIA ALBA ROOT; CALCIUM SULFIDE; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; APIS MELLIFERA; BARIUM CARBONATE 3; 3; 34; 89; 89; 89; 89; 89; 144 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0034_12383df9-a74d-457a-beeb-d92d14b9dde0 50181-0034 HUMAN OTC DRUG MBM 7 Lung Coccus Cacti, Lung (Suis), Ignatia Amara, Causticum, Natrum Muriaticum LIQUID ORAL 20140102 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. PROTORTONIA CACTI; SUS SCROFA LUNG; STRYCHNOS IGNATII SEED; CAUSTICUM; SODIUM CHLORIDE 3; 3; 34; 233; 233 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0035_6803ba40-83b1-4ef4-a574-155d7e256db8 50181-0035 HUMAN OTC DRUG BioTox Gut Cochlearia Armoracia, Phytolacca Decandra, Chelidonium Majus, Intestinal Mucosa, Spleen, Hepar Bovine, Thymus, Salmonella Enteritidis, Helicobacter Pylori, Nux Vomica, Salmonella Paratyphi, Botulinum LIQUID ORAL 20140103 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. HORSERADISH; PHYTOLACCA AMERICANA ROOT; CHELIDONIUM MAJUS; BOS TAURUS INTESTINAL MUCOSA; SUS SCROFA SPLEEN; BEEF LIVER; SUS SCROFA THYMUS; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; HELICOBACTER PYLORI; STRYCHNOS NUX-VOMICA SEED; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI; BOTULINUM TOXIN TYPE A 3; 3; 3; 8; 8; 8; 8; 12; 15; 3; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0036_d54b0607-ad30-4e12-be42-4b4697643988 50181-0036 HUMAN OTC DRUG Candida Ease Borax, Thuja Occidentalis, Arsenicum Album, Kreosotum, Sulphur, Candida Parapsilosis, Candida Albicans, Aspergillus Niger, Mucor Racemosus, Candida Krusei, Candida Pseudotropicalis, Candida Tropicalis LIQUID ORAL 20160809 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. SODIUM BORATE; THUJA OCCIDENTALIS LEAFY TWIG; ARSENIC TRIOXIDE; WOOD CREOSOTE; SULFUR; CANDIDA PARAPSILOSIS; CANDIDA ALBICANS; ASPERGILLUS NIGER VAR. NIGER; MUCOR RACEMOSUS; ISSATCHENKIA ORIENTALIS WHOLE; KLUYVEROMYCES MARXIANUS; CANDIDA TROPICALIS 3; 3; 6; 6; 6; 12; 15; 12; 12; 14; 32; 34 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0037_85a14a12-a1d1-4830-bde9-98eaf743ce1a 50181-0037 HUMAN OTC DRUG 1 Bladder Berberis Vulgaris, Thuja Occidentalis, Apis Mellifica, Pulsatilla, Staphysagria, Baryta Carbonica, Bryonia, Hepar Sulphuris Calcareum LIQUID ORAL 20140103 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. BERBERIS VULGARIS ROOT BARK; THUJA OCCIDENTALIS LEAF; APIS MELLIFERA; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; BARIUM CARBONATE; BRYONIA ALBA ROOT; CALCIUM SULFIDE 3; 30; 200; 200; 200; 1; 1; 1 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50181-0038_e4215264-661d-4d07-a48b-929ace08e4a3 50181-0038 HUMAN OTC DRUG BioTox Lyme Phytolacca Decandra, Ehrlichia, Mycoplasma Pneumoniae, Borrelia Burgdorferi, Babesia Microti, Coxiella Burnetii, Chelidonium Majus, Herpes Zoster, Francisella Tularensis, Rickettsia Rickettsii LIQUID ORAL 20140313 20190310 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education PHYTOLACCA AMERICANA ROOT; EHRLICHIA CHAFFEENSIS; MYCOPLASMA PNEUMONIAE; BORRELIA BURGDORFERI; BABESIA MICROTI; COXIELLA BURNETII; CHELIDONIUM MAJUS; HUMAN HERPESVIRUS 3; FRANCISELLA TULARENSIS; RICKETTSIA RICKETTSII 6; 8; 9; 12; 15; 30; 6; 6; 6; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0040_80875745-28f9-406d-8553-02c1d410c8ac 50181-0040 HUMAN OTC DRUG BIOTOX STD 2 Chelidonium Majus, Phytolacca Decandra, Herpes Zoster Nosode, Herpes Simplex 1 Nosode, Herpes Simplex 2 Nosode, Sulphur LIQUID ORAL 20150113 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. CHELIDONIUM MAJUS; PHYTOLACCA AMERICANA ROOT; HUMAN HERPESVIRUS 3; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; SULFUR 3; 3; 12; 30; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 50181-0041_467fd45d-c37c-485a-a1f0-58b16240ecba 50181-0041 HUMAN OTC DRUG Neurobalance Pro Adrenocorticotrophin, GABA, Glutamic Acid, Norepinephrine, Acetylcholine Chloride, Adrenalinum, L-Dopa, Serotonin (Hydrochloride), Thyroidinum (Suis), Anacardium Orientale, Baryta Carbonica, Calcarea Carbonica, Stramonium LIQUID ORAL 20151002 UNAPPROVED HOMEOPATHIC The Wellness Center for Reseach and Education, Inc. CORTICOTROPIN; .GAMMA.-AMINOBUTYRIC ACID; GLUTAMIC ACID; NOREPINEPHRINE; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; LEVODOPA; SEROTONIN HYDROCHLORIDE; THYROID, PORCINE; SEMECARPUS ANACARDIUM JUICE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; DATURA STRAMONIUM 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0042_bd3acb72-ea71-4ed0-8c07-6b50250ea62c 50181-0042 HUMAN OTC DRUG BIOTOX V MMR Cochlearia Armoracia, Varicella Zoster Nosode, Spleen (Suis), Thymus (Suis), Hepar Suis, Epstein-Barr Virus Nosode, Morbillinum, Meningococcus Nosode, Parotidinum, Rubella Nosode, Poliomyelitis Nosode LIQUID ORAL 20140519 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. HORSERADISH; HUMAN HERPESVIRUS 3; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; PORK LIVER; HUMAN HERPESVIRUS 4; MEASLES VIRUS; JAPANESE ENCEPHALITIS VIRUS; MUMPS VIRUS; RUBELLA VIRUS; POLIOVIRUS 3; 6; 8; 8; 8; 9; 12; 15; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 50181-0043_05b13696-c2ab-4590-b884-dd2341617548 50181-0043 HUMAN OTC DRUG Radiation Chelidonium Majus, Fucus Vesiculosus, Hypericum Perforatum, Sulphur, Cesium Chloride, Glandula Suprarenalis Suis, Thyroidinum (Suis), Strontium Carbonicum, Cadmium Iodatum, Cadmium Sulphuricum, X-Ray, Radium Bromatum, Uranium Nitricum, Electricitas, Plutonium Nitricum LIQUID ORAL 20140513 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. CHELIDONIUM MAJUS; FUCUS VESICULOSUS; HYPERICUM PERFORATUM; SULFUR; CESIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYROID; STRONTIUM CARBONATE; CADMIUM IODIDE; CADMIUM SULFATE; ALCOHOL, X-RAY EXPOSED (1000 RAD); RADIUM BROMIDE; URANYL NITRATE HEXAHYDRATE; LACTOSE; PLUTONIUM 3; 3; 6; 6; 6; 8; 8; 8; 8; 8; 8; 15; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0044_dc661061-8839-44b0-a568-c05e52cc7893 50181-0044 HUMAN OTC DRUG ALL FLU Aconitum napellus, Arsenicum iodatum, Bryonia (Alba), Eupatorium perfoliatum, Gelsenium sempervirens, Helix tosta, PELLET ORAL 20140619 20190714 UNAPPROVED HOMEOPATHIC The Wellness Center For Research and Education ACONITUM NAPELLUS; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ESCARGOT SHELL, COOKED; HYDROGEN; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); WOOD CREOSOTE; PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200 [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g N 20181231 50181-0045_b345d724-b84b-468a-bd78-53509bd2c3a0 50181-0045 HUMAN OTC DRUG BioTox Bac I Cochlearia armoracia, Taraxacum officinale, Tabebuia impetiginosa, Brucella abortus, Colibacillinum cum natrum muriaticum, Germanium, Pertussinum, Anthracinum, Bacillus tetani, Pyrogenium, Coxiella burnetii, Francisella tularensis, Yersinia enterocolitica, Brucella melitensis, Citrobacter diversus, Bacillus cereus, Serratia marcescenis, Enterobacter aerogenes, Pestinum, Pseudomonas aeruginosa, Proteus (mirabilis) LIQUID ORAL 20140408 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education HORSERADISH; TARAXACUM OFFICINALE; TABEBUIA IMPETIGINOSA BARK; BRUCELLA ABORTUS; ESCHERICHIA COLI; GERMANIUM; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; CLOSTRIDIUM TETANI; RANCID BEEF; COXIELLA BURNETII; FRANCISELLA TULARENSIS; YERSINIA ENTEROCOLITICA; BRUCELLA MELITENSIS; CITROBACTER KOSERI; BACILLUS CEREUS; SERRATIA MARCESCENS; ENTEROBACTER AEROGENES; YERSINIA PESTIS; PSEUDOMONAS AERUGINOSA; PROTEUS MIRABILIS 3; 3; 3; 12; 12; 15; 30; 60; 60; 60; 60; 60; 60; 9; 9; 12; 12; 15; 15; 60; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [iU]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0046_157fbb2e-3bcc-4d91-a264-edd3dc6460ba 50181-0046 HUMAN OTC DRUG BIOTOX BAC 2 Streptococcus viridans, Chlamydia trachomatis, Bacillus tetani, Meningococcus nosode, Phytolacca decandra, Streptococcus agalactiae, Streptococcus pheumoniae, LIQUID ORAL 20140512 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. STREPTOCOCCUS VIRIDANS GROUP; CHLAMYDIA TRACHOMATIS; CLOSTRIDIUM TETANI; NEISSERIA MENINGITIDIS; PHYTOLACCA AMERICANA ROOT; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS PNEUMONIAE; ENTEROCOCCUS FAECALIS; STREPTOCOCCUS MUTANS; SHIGELLA DYSENTERIAE; LISTERIA MONOCYTOGENES; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS UBERIS; CLOSTRIDIUM PERFRINGENS; STREPTOCOCCUS EQUINUS 8; 9; 12; 15; 6; 6; 6; 9; 9; 12; 12; 12; 12; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0048_c776086b-304d-4eab-a8f8-87c42cb8c538 50181-0048 HUMAN OTC DRUG 13 Female Phytolacca decandra, Scrophularia nodosa, Cimicifuga racemosa, Calcarea carbonica, Causticum, Graphites, Kali phosphoricum, Lilium tigrinum, Sulphur LIQUID ORAL 20140904 UNAPPROVED HOMEOPATHIC The Wellness Center For Research and Education PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; BLACK COHOSH; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; GRAPHITE; POTASSIUM PHOSPHATE, DIBASIC; LILIUM LANCIFOLIUM WHOLE FLOWERING; SULFUR 3; 3; 200; 1; 1; 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 50181-0049_b9b9805c-5f63-45ca-9cb7-ed8f8a9bdc31 50181-0049 HUMAN OTC DRUG SLIM Lycopodium Clavatum, Phytolacca Decandra, Abies Canadensis, Ammonium Bromatum, Ammonium Muriatiucm, Pulsatilla (Vulgaris), Kali Bichromicum, Ammonium Carbonicum, Fucus Vesiculosus, Capiscum Annuum, Argentum Nitricum, Silicea, Glandula Suprarenalis Bovine, Calcarea Arsenicica, Ferrum Metallicum, Antimonium Crudum, Calcarea Carbonica, Graphites, Kali Carbonicum, Anacaridum Oreintale, Iodium, Thyroidium (Suis), Leptin LIQUID ORAL 20150401 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education LYCOPODIUM CLAVATUM SPORE; PHYTOLACCA AMERICANA ROOT; TSUGA CANADENSIS BARK; AMMONIUM BROMIDE; AMMONIUM CHLORIDE; PULSATILLA VULGARIS; POTASSIUM DICHROMATE; AMMONIUM CARBONATE; FUCUS VESICULOSUS; CAPSICUM; SILVER NITRATE; SILICON DIOXIDE; BOS TAURUS ADRENAL GLAND; CALCIUM ARSENATE; IRON; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; POTASSIUM CARBONATE; SEMECARPUS ANACARDIUM JUICE; IODINE; THYROID, PORCINE; LEPTIN HUMAN 2; 3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 8; 8; 12; 12; 12; 12; 12; 30; 4; 4; 5; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0050_945cf7e3-343f-4a98-97c9-b5aa40444c43 50181-0050 HUMAN OTC DRUG 9 Spleen Pancreas CEANOTHUS AMERICANUS, SENNA (CASSIA ANGUSTIFOLIA), CHIONANTHUS VIRGINICA, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, SEPIA LIQUID ORAL 20141215 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. CEANOTHUS AMERICANUS LEAF; SENNA LEAF; CHIONANTHUS VIRGINICUS BARK; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; SEPIA OFFICINALIS JUICE 3; 3; 30; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 50181-0051_1b3653af-81be-4e5b-9ea2-a5fe37170859 50181-0051 HUMAN OTC DRUG 10 STOMACH CONDURANGO, ANTIMONIUM CRUDUM, AURUM METALLICUM, HYOSCYAMUS NIGER, NUX VOMICA, SULPHUR LIQUID ORAL 20141208 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. MARSDENIA CONDURANGO BARK; ANTIMONY TRISULFIDE; GOLD; HYOSCYAMUS NIGER; STRYCHNOS NUX-VOMICA SEED; SULFUR 3; 1; 1; 1; 1; 1 [hp_X]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 50181-0052_ddf8fdc4-1e1f-401c-89a3-6f2f0a14dcef 50181-0052 HUMAN OTC DRUG 7 LUNG COCCUS CACTI, IGNATIA AMARA, CAUSTICUM, NATRUM MURIATICUM LIQUID ORAL 20141205 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. PROTORTONIA CACTI; STRYCHNOS IGNATII SEED; CAUSTICUM; SODIUM CHLORIDE 3; 600; 1; 5 [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 50181-0053_3f430f6b-4a2c-4be5-bbe6-b7dbe2a3dfc3 50181-0053 HUMAN PRESCRIPTION DRUG HAIR STIM Pediculus Capitis, Thyroidinum (Suis), Baryta Carbonica, Borax, Calcarea Carbonica, Cinchona Officinalis, Glandula Suprarenalis Suis, Hydrofluoricum Acidum, Mercurius Solubilis, Mezereum, Natrum Muriaticum, Phosphorus, Pulsatilla (Pratensis), Sepia, Silicea, Sulphur, Thuja Occidentalis, Vinca Minor LIQUID ORAL 20150122 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. PEDICULUS HUMANUS VAR. CAPITIS; THYROID, PORCINE; BARIUM CARBONATE; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CINCHONA OFFICINALIS BARK; SUS SCROFA ADRENAL GLAND; HYDROFLUORIC ACID; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA PRATENSIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; VINCA MINOR 4; 4; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50181-0054_bb63efa1-2908-4b4d-b9b6-1394dafae306 50181-0054 HUMAN OTC DRUG All Flu Aconitum Napellus, Arsenicum Iodatum, Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Helix Tosta, Hydrogen, Influenzinum, Kreosotum, Phosphorus, Teucrium Scorodonia, Thuja Occidentalis, Veratrum Viride, Anas Barbariae, Hepatis Et Cordis Extractum PELLET ORAL 20150312 UNAPPROVED HOMEOPATHIC The Wellness Center For Research and Education ACONITUM NAPELLUS; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ESCARGOT SHELL, COOKED; HYDROGEN; INFLUENZA A VIRUS; INFLUENZA B VIRUS; WOOD CREOSOTE; PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200 [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g N 20181231 50181-0055_e4b23bfb-9493-4abc-b02a-f63ec38edadb 50181-0055 HUMAN OTC DRUG BioTox Hep Cochlearia Armoracia, Chelidonium Majus, Arsenicum Album, Hepar Suis, Spleen (Suis), Thymus (Suis), Hepatitis C Nosode, Hepatitis A Nosode, Hepatitis B Nosode LIQUID ORAL 20151015 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. HORSERADISH; CHELIDONIUM MAJUS; ARSENIC TRIOXIDE; PORK LIVER; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; HEPATITIS C VIRUS; HEPATITIS A VIRUS; HEPATITIS B VIRUS 3; 3; 6; 8; 8; 8; 17; 17; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50181-0056_f3f49c2e-ad71-4524-a7fc-4ec987e46401 50181-0056 HUMAN OTC DRUG Biotox Lyme Phytolacca Decandra, Mycoplasma Pneumoniae, Borrelia Burgdorferi Nosode, Ehrlichia Nosode (Canine), Babesia Microti, Coxiella Burnetii, Chelidonium Majus, Herpes Zoster Nosode, Francisella Tularensis, Rickettsia Prowazekii LIQUID ORAL 20160324 UNAPPROVED HOMEOPATHIC The Wellness Center for Research and Education, Inc. PHYTOLACCA AMERICANA ROOT; MYCOPLASMA PNEUMONIAE; BORRELIA BURGDORFERI; EHRLICHIA CANIS; BABESIA MICROTI; COXIELLA BURNETII; CHELIDONIUM MAJUS; HUMAN HERPESVIRUS 3; FRANCISELLA TULARENSIS; RICKETTSIA PROWAZEKII 6; 9; 12; 15; 15; 30; 6; 6; 6; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50183-112_c42571fb-3f0e-4328-92c7-759ff5140b55 50183-112 HUMAN OTC DRUG go wipes benzalkonium chloride CLOTH TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 American Hygiene Industries BENZALKONIUM CHLORIDE 3.48 g/34.8g E 20171231 50184-1000_438aff74-9816-41f3-967b-0c02dc008179 50184-1000 HUMAN OTC DRUG help me broad spectrum spf 30 sunscreen retinol day treatment lotion Avobenzone LIQUID TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 Philosophy Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .6; 3; 1.5; .45; 1.2 mL/30mL; mL/30mL; mL/30mL; mL/30mL; mL/30mL E 20171231 50184-1005_148012ef-5c25-4c53-b11e-24085a5bb0d9 50184-1005 HUMAN OTC DRUG clear days ahead oil-free salicylic acid acne treatment cleanser Salicylic Acid LIQUID TOPICAL 20120401 OTC MONOGRAPH FINAL part333D Philosophy Inc. SALICYLIC ACID 2.4 mL/240mL N 20181231 50184-1010_0c7d5336-1b7a-4520-943b-b4e09fc03432 50184-1010 HUMAN OTC DRUG clear days ahead oil-free salicylic acid acne treatment and moisturizer Salicylic Acid CREAM TOPICAL 20120401 OTC MONOGRAPH FINAL part333D Philosophy Inc. SALICYLIC ACID .6 mL/60mL N 20181231 50184-1015_1dff6f6e-e4f4-43c6-8b37-498e692bc859 50184-1015 HUMAN OTC DRUG clear days ahead overnight repair salicylic acid acne treatment pads Salicylic Acid CLOTH TOPICAL 20120401 OTC MONOGRAPH FINAL part333D Philosophy Inc. SALICYLIC ACID 283.5 mg/56.7g N 20181231 50184-1020_b5fe3060-a2ce-430b-b1e3-26edc1a06674 50184-1020 HUMAN OTC DRUG clear days ahead fast-acting salicylic acid acne spot treatment Salicylic Acid GEL TOPICAL 20120401 OTC MONOGRAPH FINAL part333D Philosophy SALICYLIC ACID .3 mL/15mL N 20181231 50184-1025_38c3d5fb-ae5d-4bfd-9649-1485e4c42d9d 50184-1025 HUMAN OTC DRUG clear days ahead 30-day acne trial kit salicylic acid KIT TOPICAL 20120401 OTC MONOGRAPH FINAL part333D Philosophy, Inc. N 20181231 50184-1026_9705f8c0-9b78-4918-b06e-ddc730d93caf 50184-1026 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen natural ivory Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE 882.7 mg/9.1g N 20181231 50184-1027_19498a1d-4692-4f5a-be99-24cdae00d51c 50184-1027 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen beige Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE 882.7 mg/9.1g N 20181231 50184-1028_ed1a3739-b64f-46d8-80c7-878630c30525 50184-1028 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen bronze Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE 882.7 mg/9.1g N 20181231 50184-1029_3ef2d5dc-1b60-46d2-a7f2-7ef344476966 50184-1029 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen rich Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE 882.7 mg/9.1g N 20181231 50184-1030_acc9bec2-b872-4d2c-9505-6e7f4194b423 50184-1030 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen extra rich Zinc Oxide CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE 882.7 mg/9.1g N 20181231 50184-1031_bf4e2bad-073f-4078-b93c-c7579cc31f8a 50184-1031 HUMAN OTC DRUG Keep the Peace Broad Spectrum SPF 20 Sunscreen Protective Color Corrector Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; ZINC OXIDE 11.52; 2.772 g/60mL; g/60mL E 20171231 50184-1032_2082c139-d898-4829-a64e-0cf83086477e 50184-1032 HUMAN OTC DRUG hope in a jar broad spectrum spf 25 sunscreen and moisturizer for all skin types Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 Philosophy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.088; 2.838; 3.041; 1.733; 3.96 g/60mL; g/60mL; g/60mL; g/60mL; g/60mL E 20171231 50184-1033_882bbc29-ee32-4f06-92f5-92836045d18b 50184-1033 HUMAN OTC DRUG hope in a jar a to z cream broad spectrum spf 20 sunscreen Titanium Dioxide, zinc oxide CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 Philosophy TITANIUM DIOXIDE; ZINC OXIDE 3.35; 5.49 g/30mL; g/30mL N 20181231 50184-1034_80501217-b3b3-421e-8b1a-2024a74e23f5 50184-1034 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen natural ivory Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE; TITANIUM DIOXIDE 882.7; 5.733 mg/9.1g; g/9.1g N 20181231 50184-1035_f0dde3fb-593f-4d13-8ec9-55b3b1621a5b 50184-1035 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen medium beige Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE; TITANIUM DIOXIDE .455; 5.49 mg/9.1g; mg/9.1g N 20181231 50184-1036_f23dc8f8-22f6-4fbc-8489-1b6e77d323bd 50184-1036 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen beige Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE; TITANIUM DIOXIDE 882.7; 5.49 mg/9.1g; mg/9.1g N 20181231 50184-1037_56191ccf-b83c-459f-a1f0-9cd9f8c2a273 50184-1037 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen fair Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE; TITANIUM DIOXIDE 882.7; 5.49 mg/9.1g; mg/9.1g N 20181231 50184-1038_a9962ddc-c3b8-47ce-9569-3948377bc2a4 50184-1038 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen honey Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE; TITANIUM DIOXIDE 882.7; 5.49 mg/9.1g; mg/9.1g N 20181231 50184-1039_e41d7335-3ea9-439d-96c5-988b7f6bd4f4 50184-1039 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen light bronze Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE; TITANIUM DIOXIDE 882.7; 5.49 mg/9.1g; mg/9.1g N 20181231 50184-1040_245c2233-9cd6-4f69-88d5-267997047952 50184-1040 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen rich toffee Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE; TITANIUM DIOXIDE 882.7; 5.49 mg/9.1g; mg/9.1g N 20181231 50184-1041_9e14ab5c-b8f7-46d4-a207-c0ec58503ebc 50184-1041 HUMAN OTC DRUG supernatural airbrushed canvas broad spectrum spf 15 sunscreen sand Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 philosophy ZINC OXIDE; TITANIUM DIOXIDE 882.7; 5.49 mg/9.1g; mg/9.1g N 20181231 50184-1050_df34e2b1-f924-41e2-bf25-54c446e94154 50184-1050 HUMAN OTC DRUG Take A Deep Breath Cushion Foundation SPF 20 Shade xx Titanium Dioxide and Octinoxate LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; OCTINOXATE .253; .525 g/13mL; g/13mL N 20181231 50184-1053_df34e2b1-f924-41e2-bf25-54c446e94154 50184-1053 HUMAN OTC DRUG Take A Deep Breath Cushion Foundation SPF 20 Shade xx Titanium Dioxide and Octinoxate LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; OCTINOXATE .253; .525 g/13mL; g/13mL N 20181231 50184-1054_df34e2b1-f924-41e2-bf25-54c446e94154 50184-1054 HUMAN OTC DRUG Take A Deep Breath Cushion Foundation SPF 20 Shade xx Titanium Dioxide and Octinoxate LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; OCTINOXATE .253; .525 g/13mL; g/13mL N 20181231 50184-1055_df34e2b1-f924-41e2-bf25-54c446e94154 50184-1055 HUMAN OTC DRUG Take A Deep Breath Cushion Foundation SPF 20 Shade xx Titanium Dioxide and Octinoxate LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; OCTINOXATE .253; .525 g/13mL; g/13mL N 20181231 50184-1056_df34e2b1-f924-41e2-bf25-54c446e94154 50184-1056 HUMAN OTC DRUG Take A Deep Breath Cushion Foundation SPF 20 Shade xx Titanium Dioxide and Octinoxate LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; OCTINOXATE .253; .525 g/13mL; g/13mL N 20181231 50184-1057_df34e2b1-f924-41e2-bf25-54c446e94154 50184-1057 HUMAN OTC DRUG Take A Deep Breath Cushion Foundation SPF 20 Shade xx Titanium Dioxide and Octinoxate LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; OCTINOXATE .253; .525 g/13mL; g/13mL N 20181231 50184-1058_df34e2b1-f924-41e2-bf25-54c446e94154 50184-1058 HUMAN OTC DRUG Take A Deep Breath Cushion Foundation SPF 20 Shade xx Titanium Dioxide and Octinoxate LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; OCTINOXATE .253; .525 g/13mL; g/13mL N 20181231 50184-1059_df34e2b1-f924-41e2-bf25-54c446e94154 50184-1059 HUMAN OTC DRUG Take A Deep Breath Cushion Foundation SPF 20 Shade xx Titanium Dioxide and Octinoxate LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; OCTINOXATE .253; .525 g/13mL; g/13mL N 20181231 50184-2900_71718b49-ed10-4144-a696-74646ef93f7e 50184-2900 HUMAN OTC DRUG Hope In A Bottle SALICYLIC ACID LOTION TOPICAL 20110928 OTC MONOGRAPH FINAL part333D Philosophy, Inc. SALICYLIC ACID 1.184 mL/59.2mL E 20171231 50184-3800_b189b6ba-6d2b-4142-8ba2-2719dd5607a6 50184-3800 HUMAN OTC DRUG Supernatural Poreless Flawless Tinted SPF 15 Octisalate and Titanium Dioxide CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; OCTISALATE 40; 50 mg/g; mg/g N 20191231 50184-4700_50e7bd88-779b-424f-aa74-938a90603f7e 50184-4700 HUMAN OTC DRUG Shelter Tinted octinoxate, octisalate, oxybenzone, titanium dioxide CREAM TOPICAL 20040914 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 50; 50; 10 mg/g; mg/g; mg/g; mg/g E 20171231 50184-4800_d57415b0-ed15-4226-9d41-184f96e1ca91 50184-4800 HUMAN OTC DRUG Shelter Octinoxate and Octisalate and Oxybenzone and Titanium Dioxide CREAM TOPICAL 20040914 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 50; 50; 12 mg/g; mg/g; mg/g; mg/g E 20171231 50184-6000_29725a47-cab0-4a10-b849-d1da1580890b 50184-6000 HUMAN OTC DRUG Supernatural Superbeautiful Makeup SPF 15 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; ZINC OXIDE 45; 20 mg/g; mg/g E 20171231 50184-6100_9cca60d6-7b77-4601-bfc1-d9800406e5a3 50184-6100 HUMAN OTC DRUG Hope Oil Free Moisturizer SPF 30 Octinoxate and Octisalate and Oxybenzone and zinc oxide CREAM TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 75; 50; 40; 45 mg/g; mg/g; mg/g; mg/g E 20171231 50184-6200_4ffd2344-84c8-487c-8863-55ed5aff6d8b 50184-6200 HUMAN OTC DRUG Hope In A Jar SPF 25 avobenzone and homosalate and octisalate and octocrylene and oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 45; 50; 27.5; 50 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 50184-6300_6f514ddf-08f3-40f1-af01-5b92a430fef7 50184-6300 HUMAN OTC DRUG Hope In A Tinted Moisturizer octinoxate, oxybenzone CREAM TOPICAL 20100825 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTINOXATE; OXYBENZONE 3.75; 1.75 mL/50mL; mL/50mL E 20171231 50184-6400_5de3d011-a893-498f-b8ad-1c528e3c897b 50184-6400 HUMAN OTC DRUG Hope In A Jar For Dry Skin SPF broad spectrum spf 20 sunscreen and extra-rich moisturizer for normal to dry skin avobenzone, octinoxate, and oxybenzone CREAM TOPICAL 20101022 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 1.392; 4.242; 1.98 g/60mL; g/60mL; g/60mL E 20171231 50184-6500_46163b03-b532-4d5d-99f1-c9d024800086 50184-6500 HUMAN OTC DRUG Miracle Worker SPF 55 avobenzone, homosalate, octisalate, octocrylene and oxybenzone CREAM TOPICAL 20101119 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 5; 2.5; 1; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL E 20171231 50184-6600_ad44f5ba-c6f9-4f87-a3fc-1edc4ceb753c 50184-6600 HUMAN OTC DRUG Keep The Peace Protect and Correct Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20110124 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2.88; 1.8 mL/60mL; mL/60mL E 20171231 50184-6700_e8ea185f-414e-4dbb-9823-4308d1085598 50184-6700 HUMAN OTC DRUG Divine Lift Foundation SPF Octinoxate and Titanium Dioxide CREAM TOPICAL 20110105 OTC MONOGRAPH NOT FINAL part352 Philosophy Inc. OCTINOXATE; TITANIUM DIOXIDE 1.065; .71 g/14.2g; g/14.2g N 20181231 50184-6800_f408d8b4-9fa8-485a-8daf-d24a0e863ed2 50184-6800 HUMAN OTC DRUG Kiss of Hope SPF 15 Octinoxate and Oxybenzone STICK TOPICAL 20110207 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTINOXATE; OXYBENZONE .238; .102 g/3.4g; g/3.4g N 20181231 50184-6900_936d0093-f7c6-4730-b0ff-15a22a87301b 50184-6900 HUMAN OTC DRUG Kiss of Hope Pink Tinted SPF 15 Octinoxate and Oxybenzone STICK TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. OCTINOXATE; OXYBENZONE .238; .102 g/3.4g; g/3.4g N 20181231 50184-7000_51cb3fb5-c7ed-4d0c-9d9c-6f245732b918 50184-7000 HUMAN OTC DRUG Divine Illumination Divine Flawless Foundation SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20120114 OTC MONOGRAPH NOT FINAL part352 Philosophy, Inc. TITANIUM DIOXIDE; ZINC OXIDE 4.68; 4.5 mL/45mL; mL/45mL N 20181231 50191-0001_0d0db30e-b120-4870-96ba-3c2696b1e999 50191-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091203 UNAPPROVED MEDICAL GAS Home Health Depot OXYGEN 99 L/100L E 20171231 50191-123_60c70d70-a9fe-7644-e053-2a91aa0a7cf6 50191-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010301 UNAPPROVED MEDICAL GAS Home Health Depot OXYGEN 99 L/100L N 20181231 50192-113_3a38ddb1-2e6b-406e-8992-a1c9cbd9acd0 50192-113 HUMAN PRESCRIPTION DRUG CAMBIA Diclofenac Potassium POWDER, FOR SOLUTION ORAL 20100420 NDA NDA022165 Nautilus Neurosciences, Inc. DICLOFENAC POTASSIUM 1 mg/mg Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 50198-2826_c26150bf-c0d5-465e-a559-ea4e61e08318 50198-2826 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090101 UNAPPROVED MEDICAL GAS WeCare Medical LLC OXYGEN 1000 mL/L E 20171231 50201-0246_b3d1e541-da02-4735-81be-b4a45f045c7b 50201-0246 HUMAN OTC DRUG Effervescent Cold Relief ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20100701 OTC MONOGRAPH FINAL part341 Tower Laboratories Ltd ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 N 20181231 50201-0421_60b769f7-eab1-1a00-e053-2a91aa0ab7a7 50201-0421 HUMAN OTC DRUG Bromo Seltzer ASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLET, EFFERVESCENT ORAL 20120716 OTC MONOGRAPH FINAL part343 Tower Laboratories Ltd SODIUM BICARBONATE; ANHYDROUS CITRIC ACID; ASPIRIN 1916; 1000; 325 mg/1; mg/1; mg/1 N 20191231 50201-2400_3e793569-811c-4f71-8c0f-06eb94edad5a 50201-2400 HUMAN PRESCRIPTION DRUG TowerX Effervescent Potassium POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20060106 UNAPPROVED DRUG OTHER Tower Laboratories Ltd POTASSIUM BICARBONATE 25 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 50201-4212_60dcb44e-3f1c-6a9c-e053-2991aa0a174f 50201-4212 HUMAN OTC DRUG Top Value Effervescent Pain Relief Apirin, Citric Acid, Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20061201 OTC MONOGRAPH FINAL part343 Tower Laboratories Ltd ASPIRIN; ANHYDROUS CITRIC ACID; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 N 20191231 50201-4213_5d0299c4-9061-ab76-e053-2991aa0afafa 50201-4213 HUMAN OTC DRUG Top Value Effervescent Pain Relief Aspirin, Citric Acid, Sodium Bicarobonate TABLET, EFFERVESCENT ORAL 20061201 OTC MONOGRAPH FINAL part343 Tower Laboratories Ltd SODIUM BICARBONATE; ASPIRIN; ANHYDROUS CITRIC ACID 1916; 325; 1000 mg/1; mg/1; mg/1 N 20191231 50201-4216_6157820d-465f-ea51-e053-2991aa0a847b 50201-4216 HUMAN OTC DRUG Good Sense Effervescent Antacid and Pain Relief Aspirin, Citric Acid, Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20130211 OTC MONOGRAPH FINAL part343 Tower Laboratories Ltd. SODIUM BICARBONATE; ASPIRIN; ANHYDROUS CITRIC ACID 1916; 325; 1000 mg/1; mg/1; mg/1 N 20191231 50201-7682_5f9d2757-1d92-b8cb-e053-2a91aa0a3c80 50201-7682 HUMAN OTC DRUG Top Value Effervescent Cold Relief Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20100701 OTC MONOGRAPH FINAL part341 Tower Laboratories Ltd ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE 325; 7.8; 2 mg/1; mg/1; mg/1 N 20181231 50201-8736_6017239d-f47d-9722-e053-2991aa0aab58 50201-8736 HUMAN OTC DRUG Good Sense Effervescent Cold Relief Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20130219 OTC MONOGRAPH FINAL part341 Tower Laboratories Ltd. ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE 325; 7.8; 2 mg/1; mg/1; mg/1 N 20181231 50211-001_559c93c2-a949-4fd9-98cb-7bb570c6de0e 50211-001 HUMAN OTC DRUG Hemo Fin Petrolatum OINTMENT RECTAL 20120910 OTC MONOGRAPH FINAL part346 PD MERC LLC PETROLATUM 93.3 g/100g E 20171231 50220-001_b1baeda9-c804-4012-8932-6f5f3a7ca4e3 50220-001 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET, FILM COATED ORAL 20100917 UNAPPROVED DRUG OTHER Tal Pharma LLC ESTRONE SODIUM SULFATE; METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] E 20171231 50220-002_b1baeda9-c804-4012-8932-6f5f3a7ca4e3 50220-002 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET, FILM COATED ORAL 20100917 UNAPPROVED DRUG OTHER Tal Pharma LLC ESTRONE SODIUM SULFATE; METHYLTESTOSTERONE 1.25; 2.5 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] E 20171231 50222-203_4bc7922d-bfb2-4450-bc47-b356a6be58ec 50222-203 HUMAN PRESCRIPTION DRUG Protopic Tacrolimus OINTMENT TOPICAL 20001208 NDA NDA050777 LEO Pharma Inc. TACROLIMUS .3 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 50222-211_4bc7922d-bfb2-4450-bc47-b356a6be58ec 50222-211 HUMAN PRESCRIPTION DRUG Protopic Tacrolimus OINTMENT TOPICAL 20001208 NDA NDA050777 LEO Pharma Inc. TACROLIMUS 1 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 50222-227_dd8e0682-9c71-4d38-88dd-a3abf09771d3 50222-227 HUMAN PRESCRIPTION DRUG Taclonex calcipotriene and betamethasone dipropionate OINTMENT TOPICAL 20080601 NDA NDA021852 LEO Pharma Inc. CALCIPOTRIENE HYDRATE; BETAMETHASONE DIPROPIONATE 50; .5 ug/g; mg/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50222-260_bcc1c92d-af88-4925-994c-ad41c711204d 50222-260 HUMAN PRESCRIPTION DRUG Dovonex Calcipotriene CREAM TOPICAL 19961001 NDA NDA020554 LEO Pharma Inc. CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 50222-302_3bd49f56-f110-492e-b95a-a7461711769e 50222-302 HUMAN PRESCRIPTION DRUG ENSTILAR calcipotriene and betamethasone dipropionate AEROSOL, FOAM TOPICAL 20151016 NDA NDA207589 LEO Pharma Inc. CALCIPOTRIENE HYDRATE; BETAMETHASONE DIPROPIONATE 50; .5 ug/g; mg/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50222-501_3d3f4506-221b-4a4d-a3a6-05c3012b4985 50222-501 HUMAN PRESCRIPTION DRUG TACLONEX calcipotriene and betamethasone dipropionate SUSPENSION TOPICAL 20080601 NDA NDA022185 LEO Pharma Inc. CALCIPOTRIENE HYDRATE; BETAMETHASONE DIPROPIONATE 50; .5 ug/g; mg/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50222-502_ce9c6324-f7f6-4bd0-bbde-8f7efde5b725 50222-502 HUMAN PRESCRIPTION DRUG Picato ingenol mebutate GEL TOPICAL 20120123 NDA NDA202833 LEO Pharma Inc. INGENOL MEBUTATE 150 ug/g Cell Death Inducer [EPC],Increased Cellular Death [PE] N 20181231 50222-503_ce9c6324-f7f6-4bd0-bbde-8f7efde5b725 50222-503 HUMAN PRESCRIPTION DRUG Picato ingenol mebutate GEL TOPICAL 20120123 NDA NDA202833 LEO Pharma Inc. INGENOL MEBUTATE 500 ug/g Cell Death Inducer [EPC],Increased Cellular Death [PE] N 20181231 50224-002_028f7e8a-ca00-4456-a1d6-b94235741d6c 50224-002 HUMAN PRESCRIPTION DRUG Refissa Tretinoin CREAM TOPICAL 20090617 ANDA ANDA076498 Suneva Medical, Inc. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 50224-002_09e54922-049f-48fe-953a-3320621413f3 50224-002 HUMAN PRESCRIPTION DRUG REFISSA TRETINOIN CREAM TOPICAL 20090617 ANDA ANDA076498 Suneva Medical, Inc. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 50225-355_f9ca8878-77e5-4644-965f-e4b75ac6fa34 50225-355 HUMAN OTC DRUG Instant Hand Sanitizer Instant Hand Sanitizer GEL TOPICAL 20100106 OTC MONOGRAPH FINAL part333 Global Protection USA, Inc. ALCOHOL 60 g/mL N 20181231 50227-0101_574dfd30-4cb0-c05b-e053-2a91aa0a0d8b 50227-0101 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate LIQUID ORAL 20160122 ANDA ANDA077789 Patterson Dental Supply Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 50227-0101_574e4ad1-33da-4b53-e053-2a91aa0a7714 50227-0101 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate LIQUID ORAL 20170630 ANDA ANDA077789 Patterson Dental Supply Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 50227-0501_b67d45f7-77f8-4a06-aa4d-4db91a9a7d92 50227-0501 HUMAN PRESCRIPTION DRUG Topical 60 Sec Sodium Fluoride Strawberry Sodium Fluoride AEROSOL, FOAM TOPICAL 19970401 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 123 mg/g E 20171231 50227-0511_719aaea7-cf05-4f74-8e97-8284cdf535bb 50227-0511 HUMAN PRESCRIPTION DRUG Topical 60 Sec Sodium Fluoride Mint Sodium Fluoride AEROSOL, FOAM TOPICAL 19970401 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 123 mg/g E 20171231 50227-0521_b711eb86-8ef8-48cf-a4ea-6c4c49a877cc 50227-0521 HUMAN PRESCRIPTION DRUG Topical 60 Sec Sodium Fluoride Bubble Gum Sodium Fluoride AEROSOL, FOAM TOPICAL 19970401 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 123 mg/g E 20171231 50227-0531_15ab2941-7281-49f5-bc25-6293893e1c73 50227-0531 HUMAN PRESCRIPTION DRUG Topical 60 Sec Sodium Fluoride Grape Sodium Fluoride AEROSOL, FOAM TOPICAL 19970401 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 123 mg/g E 20171231 50227-0541_30034c1e-56bf-4c01-b8ed-45ecfad739df 50227-0541 HUMAN PRESCRIPTION DRUG Topical 60 Sec Sodium Fluoride Orange Cream Sodium Fluoride AEROSOL, FOAM TOPICAL 19970401 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 123 mg/g E 20171231 50227-1001_e99b7dc6-6d05-4525-878e-1588f6997820 50227-1001 HUMAN OTC DRUG Patterson Dental Topical Anesthetic Benzocaine GEL DENTAL 20150201 OTC MONOGRAPH NOT FINAL part356 Patterson Dental BENZOCAINE 200 mg/g N 20181231 50227-1002_6ce363a8-0d34-44bd-bc12-5bdf7964647f 50227-1002 HUMAN OTC DRUG Patterson Dental Topical Anesthetic Benzocaine GEL DENTAL 20150201 OTC MONOGRAPH NOT FINAL part356 Patterson Dental BENZOCAINE 200 mg/g N 20181231 50227-1003_124942d9-d5da-4b67-a1ae-d4402ebf59ee 50227-1003 HUMAN OTC DRUG Patterson Dental Topical Anesthetic Benzocaine GEL DENTAL 20150201 OTC MONOGRAPH NOT FINAL part356 Patterson Dental BENZOCAINE 200 mg/g N 20181231 50227-1004_0a40ea2f-b80f-4732-bbbc-5f3ac8d8327f 50227-1004 HUMAN OTC DRUG Patterson Dental Topical Anesthetic Benzocaine GEL DENTAL 20150201 OTC MONOGRAPH NOT FINAL part356 Patterson Dental BENZOCAINE 200 mg/g N 20181231 50227-1005_233ffa06-941f-46b1-b268-24af3bade834 50227-1005 HUMAN OTC DRUG Patterson Dental Topical Anesthetic Benzocaine GEL DENTAL 20150201 OTC MONOGRAPH NOT FINAL part356 Patterson Dental BENZOCAINE 200 mg/g N 20181231 50227-1006_e706de58-1350-47c2-83d2-0b8562ac5953 50227-1006 HUMAN PRESCRIPTION DRUG Take Home Fluoride Cool Mint Sodium Fluoride GEL, DENTIFRICE DENTAL 19970415 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 5 mg/g N 20181231 50227-1007_9a87d20d-9f15-4a58-b409-b7d7fb3cac03 50227-1007 HUMAN OTC DRUG Patterson Dental Topical Anesthetic Benzocaine GEL DENTAL 20150201 OTC MONOGRAPH NOT FINAL part356 Patterson Dental BENZOCAINE 200 mg/g N 20181231 50227-1009_a074b589-cd9c-4a10-b672-a474c1a09e85 50227-1009 HUMAN OTC DRUG Patterson Dental Topical Anesthetic Benzocaine GEL DENTAL 20150201 OTC MONOGRAPH NOT FINAL part356 Patterson Dental BENZOCAINE 200 mg/g N 20181231 50227-1010_261c91fc-85b2-478a-8853-ceb34b07acfe 50227-1010 HUMAN OTC DRUG Patterson Dental Topical Anesthetic Benzocaine GEL DENTAL 20150201 OTC MONOGRAPH NOT FINAL part356 Patterson Dental BENZOCAINE 200 mg/g N 20181231 50227-1011_5487f2d9-caf7-4367-8cc3-11974a8df240 50227-1011 HUMAN OTC DRUG Patterson Dental Topical Anesthetic Benzocaine GEL DENTAL 20150201 OTC MONOGRAPH NOT FINAL part356 Patterson Dental BENZOCAINE 200 mg/g N 20181231 50227-1020_35407d14-a2a6-4728-a0c8-3af5af242569 50227-1020 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088389 Patterson Dental LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .02 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 50227-1030_660ae637-2446-44ea-b0e4-45e7828a5b90 50227-1030 HUMAN PRESCRIPTION DRUG LIDOCAINE Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 Patterson Dental LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 50227-1040_9d18ab68-5316-408b-b2d1-39e844a85f0e 50227-1040 HUMAN PRESCRIPTION DRUG ARTICAINE Articaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20141222 NDA NDA020971 Patterson Dental ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 50227-1050_bc5f3728-4993-45a1-a873-3750883a975a 50227-1050 HUMAN PRESCRIPTION DRUG ARTICAINE Articaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20141222 NDA NDA020971 Patterson Dental ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 50227-1080_2aeda61d-8b92-4bf7-81c5-8734d3a159a4 50227-1080 HUMAN PRESCRIPTION DRUG Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088387 Patterson Dental Supply, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 50227-1090_2aeda61d-8b92-4bf7-81c5-8734d3a159a4 50227-1090 HUMAN PRESCRIPTION DRUG Mepivacaine with Levonordefrin Mepivacaine Hydrochloride and Levonordefrin INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088388 Patterson Dental Supply, Inc. MEPIVACAINE HYDROCHLORIDE; LEVONORDEFRIN 20; .05 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 50227-2110_ab34ed6b-565e-43b1-ac3f-41092504f48b 50227-2110 HUMAN OTC DRUG Topical Anesthetic Pina Colada Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental Supply Inc BENZOCAINE 220 mg/g E 20171231 50227-2111_22efcf7c-4ffd-4519-ad4a-05cf422a4882 50227-2111 HUMAN OTC DRUG Topical Anesthetic Strawberry Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental Supply Inc BENZOCAINE 220 mg/g E 20171231 50227-2112_7f2da304-84cf-435c-9246-903a05ef2cdc 50227-2112 HUMAN OTC DRUG Topical Anesthetic Mint Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental Supply Inc BENZOCAINE 220 mg/g E 20171231 50227-2113_b56a0462-a028-4d4d-8a21-036ac1ac53bc 50227-2113 HUMAN OTC DRUG Topical Anesthetic Raspberry Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental Supply Inc BENZOCAINE 220 mg/g E 20171231 50227-2114_561311f4-566e-454f-a451-1b84ebfad810 50227-2114 HUMAN OTC DRUG Topical Anesthetic Bubble Gum Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental Supply Inc BENZOCAINE 220 mg/g E 20171231 50227-2115_33c213ed-f380-4b4b-90cd-8ead44c7d8a5 50227-2115 HUMAN OTC DRUG Topical Anesthetic Cherry Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental Supply Inc BENZOCAINE 220 mg/g E 20171231 50227-2116_69850139-6b9d-4bcd-b448-8a2fdb0bbfa5 50227-2116 HUMAN PRESCRIPTION DRUG Topical Anesthetic Banana Benzocaine GEL, DENTIFRICE DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Patterson Dental BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 50227-3211_ea05caa6-a1b7-41f7-8c4a-8b0458dfbfc3 50227-3211 HUMAN PRESCRIPTION DRUG 60-Second Fluoride Cherry Sodium Fluoride GEL DENTAL 19780101 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 12.3 mg/g E 20171231 50227-3221_ea05caa6-a1b7-41f7-8c4a-8b0458dfbfc3 50227-3221 HUMAN PRESCRIPTION DRUG 60-Second Fluoride Mint Sodium Fluoride GEL DENTAL 19780101 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 12.3 mg/g E 20171231 50227-3241_ea05caa6-a1b7-41f7-8c4a-8b0458dfbfc3 50227-3241 HUMAN PRESCRIPTION DRUG 60-Second Fluoride Pina Colada Sodium Fluoride GEL DENTAL 19780101 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 12.3 mg/g E 20171231 50227-3251_ea05caa6-a1b7-41f7-8c4a-8b0458dfbfc3 50227-3251 HUMAN PRESCRIPTION DRUG 60-Second Fluoride Bubble Gum Sodium Fluoride GEL DENTAL 19780101 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 12.3 mg/g E 20171231 50227-3271_ea05caa6-a1b7-41f7-8c4a-8b0458dfbfc3 50227-3271 HUMAN PRESCRIPTION DRUG 60-Second Fluoride Orange Cream Sodium Fluoride GEL DENTAL 19780101 UNAPPROVED DRUG OTHER Patterson Dental Supply Inc SODIUM FLUORIDE 12.3 mg/g E 20171231 50228-105_f564346f-5acb-44a5-8f92-b89d979e6eeb 50228-105 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20150201 ANDA ANDA203769 ScieGen Pharmaceuticals Inc METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50228-106_f564346f-5acb-44a5-8f92-b89d979e6eeb 50228-106 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20150201 ANDA ANDA203769 ScieGen Pharmaceuticals Inc METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50228-107_f564346f-5acb-44a5-8f92-b89d979e6eeb 50228-107 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20150201 ANDA ANDA203769 ScieGen Pharmaceuticals Inc METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50228-109_a4a840bd-f143-489d-b624-39e556bd4d42 50228-109 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20140127 ANDA ANDA203374 ScieGen Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 50228-111_bca0e012-cfa2-4b92-bff8-ccfcb776c78e 50228-111 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140723 ANDA ANDA203018 ScieGen Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50228-112_bca0e012-cfa2-4b92-bff8-ccfcb776c78e 50228-112 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140205 ANDA ANDA203018 ScieGen Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50228-113_ec530678-4b07-4a74-abc6-3b69d0cb3699 50228-113 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20150316 ANDA ANDA204597 ScieGen Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50228-114_ec530678-4b07-4a74-abc6-3b69d0cb3699 50228-114 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20150316 ANDA ANDA204597 ScieGen Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50228-115_ec530678-4b07-4a74-abc6-3b69d0cb3699 50228-115 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20150316 ANDA ANDA204597 ScieGen Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50228-121_c6970c4a-8d8b-40da-9169-ea5a92bef34e 50228-121 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20150915 ANDA ANDA204165 ScieGen Pharmaceuticals Inc CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 50228-124_c6970c4a-8d8b-40da-9169-ea5a92bef34e 50228-124 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20150915 ANDA ANDA204165 ScieGen Pharmaceuticals Inc CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 50228-126_da108147-2835-447a-a7df-aa892b3cd7d0 50228-126 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 ScieGen Pharmaceuticals Inc PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 50228-127_da108147-2835-447a-a7df-aa892b3cd7d0 50228-127 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 ScieGen Pharmaceuticals Inc PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 50228-128_da108147-2835-447a-a7df-aa892b3cd7d0 50228-128 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 ScieGen Pharmaceuticals Inc PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 50228-129_da108147-2835-447a-a7df-aa892b3cd7d0 50228-129 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 ScieGen Pharmaceuticals Inc PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 50228-130_da108147-2835-447a-a7df-aa892b3cd7d0 50228-130 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 ScieGen Pharmaceuticals Inc PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 50228-131_da108147-2835-447a-a7df-aa892b3cd7d0 50228-131 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 ScieGen Pharmaceuticals Inc PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 50228-136_d15b5a04-4aa6-4fb9-b099-328e1e8b79fa 50228-136 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride levocetirizine dihydrochloride TABLET ORAL 20140909 ANDA ANDA203646 ScieGen Pharmaceuticals, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 50228-139_b2d4fdaa-7771-4e15-9ef4-cc225f9fc244 50228-139 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20141029 ANDA ANDA203907 ScieGen Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 50228-140_b2d4fdaa-7771-4e15-9ef4-cc225f9fc244 50228-140 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20141029 ANDA ANDA203907 ScieGen Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 50228-144_628c10e5-4146-45fc-97ec-5062211674d8 50228-144 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170412 ANDA ANDA207479 ScieGen Pharmaceuticals,Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50228-145_628c10e5-4146-45fc-97ec-5062211674d8 50228-145 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170412 ANDA ANDA207479 ScieGen Pharmaceuticals,Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50228-160_c80b730f-8aa5-4237-9cc6-a580a0c84c59 50228-160 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20151207 ANDA ANDA204774 ScieGen Pharmaceuticals, Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50228-161_c80b730f-8aa5-4237-9cc6-a580a0c84c59 50228-161 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20151207 ANDA ANDA204774 ScieGen Pharmaceuticals, Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50228-162_c80b730f-8aa5-4237-9cc6-a580a0c84c59 50228-162 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20151207 ANDA ANDA204774 ScieGen Pharmaceuticals, Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50228-174_0000887d-f03d-4d32-94ef-41a5fed5a4b0 50228-174 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160301 ANDA ANDA205794 ScieGen Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50228-175_0000887d-f03d-4d32-94ef-41a5fed5a4b0 50228-175 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160301 ANDA ANDA205794 ScieGen Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50228-176_0000887d-f03d-4d32-94ef-41a5fed5a4b0 50228-176 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160301 ANDA ANDA205794 ScieGen Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50228-177_37856597-350e-423d-9157-07be64ab57ea 50228-177 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20160204 ANDA ANDA205101 ScieGen Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50228-178_37856597-350e-423d-9157-07be64ab57ea 50228-178 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20160204 ANDA ANDA205101 ScieGen Pharmaceuticals, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50228-179_ca26996a-0f54-4db6-8266-042c3f88948b 50228-179 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160218 ANDA ANDA204989 ScieGen Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50228-180_ca26996a-0f54-4db6-8266-042c3f88948b 50228-180 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160218 ANDA ANDA204989 ScieGen Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50228-181_ca26996a-0f54-4db6-8266-042c3f88948b 50228-181 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160218 ANDA ANDA204989 ScieGen Pharmaceuticals, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50228-201_8f5f5037-e3d8-4b11-af9f-67afd0b73c0e 50228-201 HUMAN OTC DRUG fexofenadine hcl fexofenadine hcl TABLET, FILM COATED ORAL 20141226 ANDA ANDA204507 ScieGen Pharmaceuticals, Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 50228-202_8f5f5037-e3d8-4b11-af9f-67afd0b73c0e 50228-202 HUMAN OTC DRUG fexofenadine hcl fexofenadine hcl TABLET, FILM COATED ORAL 20141226 ANDA ANDA204507 ScieGen Pharmaceuticals, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 50228-306_380a71e9-b411-4199-9ffa-819287f6506a 50228-306 HUMAN PRESCRIPTION DRUG Raloxifene hydrochloride Raloxifene hydrochloride TABLET, FILM COATED ORAL 20161012 ANDA ANDA206384 ScieGen Pharmaceuticals Inc RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 50228-319_d63c6f6d-4f50-40c3-ba45-e1cb005f9a91 50228-319 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20151130 ANDA ANDA206382 ScieGen Pharmaceuticals, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50228-320_d63c6f6d-4f50-40c3-ba45-e1cb005f9a91 50228-320 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20151130 ANDA ANDA206382 ScieGen Pharmaceuticals, Inc. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50228-321_d63c6f6d-4f50-40c3-ba45-e1cb005f9a91 50228-321 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20151130 ANDA ANDA206382 ScieGen Pharmaceuticals, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50228-322_d63c6f6d-4f50-40c3-ba45-e1cb005f9a91 50228-322 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, ORALLY DISINTEGRATING ORAL 20151130 ANDA ANDA206382 ScieGen Pharmaceuticals, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50228-323_aaa5693a-7832-42fe-8a81-ef28594c4b99 50228-323 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20170831 ANDA ANDA207466 ScieGen Pharmaceuticals, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 50228-324_3bf2dc99-1cf4-4c3f-9c69-7de4fc11b97b 50228-324 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160929 ANDA ANDA206383 ScieGen Pharmaceuticals Inc ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 50228-325_3bf2dc99-1cf4-4c3f-9c69-7de4fc11b97b 50228-325 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160929 ANDA ANDA206383 ScieGen Pharmaceuticals Inc ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 50228-326_3bf2dc99-1cf4-4c3f-9c69-7de4fc11b97b 50228-326 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160929 ANDA ANDA206383 ScieGen Pharmaceuticals Inc ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 50228-327_3bf2dc99-1cf4-4c3f-9c69-7de4fc11b97b 50228-327 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160929 ANDA ANDA206383 ScieGen Pharmaceuticals Inc ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 50228-328_3bf2dc99-1cf4-4c3f-9c69-7de4fc11b97b 50228-328 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160929 ANDA ANDA206383 ScieGen Pharmaceuticals Inc ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 50228-329_3bf2dc99-1cf4-4c3f-9c69-7de4fc11b97b 50228-329 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160929 ANDA ANDA206383 ScieGen Pharmaceuticals Inc ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 50228-363_ae7410ba-95a9-4a0a-9250-d7969cc0884f 50228-363 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20161206 ANDA ANDA207476 ScieGen Pharmaceuticals, Inc. OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50228-364_ae7410ba-95a9-4a0a-9250-d7969cc0884f 50228-364 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20161206 ANDA ANDA207476 ScieGen Pharmaceuticals, Inc. OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50228-381_6009a490-9290-4cc7-8fb2-d818401a078a 50228-381 HUMAN PRESCRIPTION DRUG Quetiapine Extended Release Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA209635 ScieGen Pharmaceuticals, Inc QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 50228-382_6009a490-9290-4cc7-8fb2-d818401a078a 50228-382 HUMAN PRESCRIPTION DRUG Quetiapine Extended Release Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA209635 ScieGen Pharmaceuticals, Inc QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 50228-383_6009a490-9290-4cc7-8fb2-d818401a078a 50228-383 HUMAN PRESCRIPTION DRUG Quetiapine Extended Release Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA209635 ScieGen Pharmaceuticals, Inc QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 50228-384_6009a490-9290-4cc7-8fb2-d818401a078a 50228-384 HUMAN PRESCRIPTION DRUG Quetiapine Extended Release Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA209635 ScieGen Pharmaceuticals, Inc QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 50228-451_88a7ba19-2c80-4a5b-b2ce-08bb9cbe1e78 50228-451 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160519 ANDA ANDA205519 ScieGen Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 50228-452_88a7ba19-2c80-4a5b-b2ce-08bb9cbe1e78 50228-452 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160519 ANDA ANDA205519 ScieGen Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 50228-453_88a7ba19-2c80-4a5b-b2ce-08bb9cbe1e78 50228-453 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160519 ANDA ANDA205519 ScieGen Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 50228-454_88a7ba19-2c80-4a5b-b2ce-08bb9cbe1e78 50228-454 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160519 ANDA ANDA205519 ScieGen Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 50231-211_ee17a387-a771-4ff3-a8ca-518237a141ca 50231-211 HUMAN OTC DRUG MEDISTIK DUAL MENTHOL, METHYL SALICYLATE, EUCALUPTUS STICK TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part348 Natureteq Inc. MENTHOL; METHYL SALICYLATE; EUCALYPTUS GLOBULUS LEAF 15; 30; 1 g/100g; g/100g; g/100g E 20171231 50231-311_892fd570-a20d-451f-9a6f-85d615857452 50231-311 HUMAN OTC DRUG Medistik analgesic Menthol and Methyl Salicylate STICK TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part348 Natureteq Inc. MENTHOL; METHYL SALICYLATE 15; 30 g/100g; g/100g E 20171231 50231-411_10ea9120-73ab-412f-a49c-17bcd447d1b2 50231-411 HUMAN OTC DRUG Medistik Ice Menthol and Methyl Salicylate STICK TOPICAL 20160217 OTC MONOGRAPH NOT FINAL part348 Natureteq Inc. MENTHOL; CAMPHOR OIL 10; 4 g/100mL; g/100mL E 20171231 50231-511_6f96a9b4-8485-4268-9707-f2801e5cd5a0 50231-511 HUMAN OTC DRUG Medistik Dual Hot and Cold Methyl Salicylate, Menthol SPRAY TOPICAL 20160219 OTC MONOGRAPH NOT FINAL part348 Natureteq Inc. MENTHOL; METHYL SALICYLATE 10; 12 g/100mL; g/100mL E 20171231 50232-001_62180579-6f92-6a2c-e053-2a91aa0aa2ec 50232-001 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20120514 OTC MONOGRAPH FINAL part344 BEIJING RUICHENG MEDICAL SUPPLIES CO., LTD. ISOPROPYL ALCOHOL .7 mL/mL N 20191231 50236-001_41e7889e-a183-4fea-9e12-63052f878cc0 50236-001 HUMAN PRESCRIPTION DRUG Visudyne verteporfin for injection INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20000412 NDA NDA021119 QLT Ophthalmics, Inc. VERTEPORFIN 15 mg/1 Photoabsorption [MoA],Photoenhancer [EPC],Photosensitizing Activity [PE] E 20171231 50241-011_1dd3bf4b-4372-489e-998c-4c1159c757bd 50241-011 HUMAN OTC DRUG MG DermaSan N/A LIQUID TOPICAL 20140131 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 50241-013_b200936f-f7b2-463c-a6b5-07a71e53878a 50241-013 HUMAN OTC DRUG MG DermaSan MG DermaSan LIQUID TOPICAL 20131203 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher Inc. BENZALKONIUM CHLORIDE .13 g/100g E 20171231 50241-014_33ed3686-ff68-4ad3-ab83-9fa569ae6e8b 50241-014 HUMAN OTC DRUG MG DermaClean N/A LIQUID TOPICAL 20140203 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher Inc. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 50241-020_f122c48d-1170-4cef-bd02-3e066c43b2f0 50241-020 HUMAN OTC DRUG Antibacterial Liquid Hand Parachlorometaxylenol LIQUID TOPICAL 20151112 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. CHLOROXYLENOL .3 kg/100kg N 20181231 50241-030_2dee0f59-7d36-4821-bc96-27de50b2045e 50241-030 HUMAN OTC DRUG MG DermaWash N/A LIQUID TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher Inc. CHLOROXYLENOL .3 g/100g N 20181231 50241-141_ecf9e50b-b758-4638-9e71-725c7ffb8f0b 50241-141 HUMAN OTC DRUG Skyline Antibacterial Hand Cleanser parachlorometaxylenol LIQUID TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc. CHLOROXYLENOL .3 kg/100kg N 20181231 50241-142_7f574f6f-8aee-4534-ba22-cfd03d2aa7f9 50241-142 HUMAN OTC DRUG PROBLEND Antibacterial Foam Triclosan LIQUID TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc. TRICLOSAN .3 kg/100kg E 20171231 50241-143_c619396a-7a9a-4902-8c7c-66876e8d7193 50241-143 HUMAN OTC DRUG PROBLEND Antibacterial Liquid Cleanser Parachlorometaxylenol LIQUID TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher, Inc. DBA Custom Chemical Formulators, Inc. CHLOROXYLENOL .3 kg/100kg N 20181231 50241-154_71cb4905-fe32-4ac2-beae-d76fa5a11202 50241-154 HUMAN OTC DRUG E3 Foaming Hand Sanitizer N/A LIQUID TOPICAL 20150330 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 50241-201_68ca9655-5e69-4c94-91a5-dd60385466e1 50241-201 HUMAN OTC DRUG TOTAL PERFORMANCE ANTIBACTERIAL FOAM HAND HAND LIQUID TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part333E MORGAN GALLACHER INC CHLOROXYLENOL .3 kg/100kg N 20181231 50241-246_64ba036c-2ffa-4b88-9265-f7d4d75a11de 50241-246 HUMAN OTC DRUG Hand Sanitizer Solution 101 BENZALKONIUM CHLORIDE LIQUID TOPICAL 20151113 OTC MONOGRAPH NOT FINAL part333E Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. BENZALKONIUM CHLORIDE .13 kg/100kg N 20181231 50241-300_ec9519a0-adc9-4198-b00b-7b0703ffbfa6 50241-300 HUMAN OTC DRUG Foaming Hand Hand Wash LIQUID TOPICAL 20161021 OTC MONOGRAPH NOT FINAL part333E MORGAN GALLACHER INC CHLOROXYLENOL .3 kg/100kg N 20181231 50242-040_3b8385d1-4327-4c6c-b431-766ab5fefaae 50242-040 HUMAN PRESCRIPTION DRUG XOLAIR omalizumab INJECTION, SOLUTION SUBCUTANEOUS 20030620 BLA BLA103976 Genentech, Inc. OMALIZUMAB 202.5 mg/1.4mL Anti-IgE [EPC],Decreased IgE Activity [PE],IgE-directed Antibody Interactions [MoA] N 20181231 50242-041_aecdd261-2cad-4316-925a-c1f96c560981 50242-041 HUMAN PRESCRIPTION DRUG Cathflo Activase Alteplase INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010904 BLA BLA103172 Genentech, Inc. ALTEPLASE 2.2 mg/2mL N 20181231 50242-044_86494e0d-6fb3-41d4-9894-c3d30ea9ba39 50242-044 HUMAN PRESCRIPTION DRUG Activase Alteplase KIT 19871113 BLA BLA103172 Genentech, Inc. N 20181231 50242-051_bfbe99a2-201d-4496-b574-9baee169f7da 50242-051 HUMAN PRESCRIPTION DRUG Rituxan rituximab INJECTION, SOLUTION INTRAVENOUS 19971126 BLA BLA103705 Genentech, Inc. RITUXIMAB 10 mg/mL CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC] N 20181231 50242-053_bfbe99a2-201d-4496-b574-9baee169f7da 50242-053 HUMAN PRESCRIPTION DRUG Rituxan rituximab INJECTION, SOLUTION INTRAVENOUS 19971126 BLA BLA103705 Genentech, Inc. RITUXIMAB 10 mg/mL CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC] N 20181231 50242-060_75079d22-cc98-4171-a91e-29f35b224bc9 50242-060 HUMAN PRESCRIPTION DRUG Avastin bevacizumab INJECTION, SOLUTION INTRAVENOUS 20040226 BLA BLA125085 Genentech, Inc. BEVACIZUMAB 100 mg/4mL Vascular Endothelial Growth Factor Receptor Inhibitors [MoA],Vascular Endothelial Growth Factor-directed Antibody [EPC],Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA] N 20191231 50242-061_75079d22-cc98-4171-a91e-29f35b224bc9 50242-061 HUMAN PRESCRIPTION DRUG Avastin bevacizumab INJECTION, SOLUTION INTRAVENOUS 20040226 BLA BLA125085 Genentech, Inc. BEVACIZUMAB 400 mg/16mL Vascular Endothelial Growth Factor Receptor Inhibitors [MoA],Vascular Endothelial Growth Factor-directed Antibody [EPC],Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA] N 20191231 50242-062_6631b633-d740-45eb-a544-f802a2848db2 50242-062 HUMAN PRESCRIPTION DRUG TARCEVA erlotinib hydrochloride TABLET ORAL 20050430 NDA NDA021743 Genentech, Inc. ERLOTINIB HYDROCHLORIDE 25 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 50242-063_6631b633-d740-45eb-a544-f802a2848db2 50242-063 HUMAN PRESCRIPTION DRUG TARCEVA erlotinib hydrochloride TABLET ORAL 20050430 NDA NDA021743 Genentech, Inc. ERLOTINIB HYDROCHLORIDE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 50242-064_6631b633-d740-45eb-a544-f802a2848db2 50242-064 HUMAN PRESCRIPTION DRUG TARCEVA erlotinib hydrochloride TABLET ORAL 20050430 NDA NDA021743 Genentech, Inc. ERLOTINIB HYDROCHLORIDE 150 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 50242-070_cd064735-cb5d-4d90-aa61-3929262948a3 50242-070 HUMAN PRESCRIPTION DRUG Gazyva obinutuzumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20131101 BLA BLA125486 Genentech, Inc. OBINUTUZUMAB 1000 mg/40mL CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC] N 20181231 50242-074_f2b6bd04-6837-44a6-a785-12c2138e5657 50242-074 HUMAN PRESCRIPTION DRUG Nutropin AQ NuSpin 10 somatropin INJECTION, SOLUTION SUBCUTANEOUS 19951229 NDA NDA020522 Genentech, Inc. SOMATROPIN 10 mg/2mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] N 20191231 50242-075_f2b6bd04-6837-44a6-a785-12c2138e5657 50242-075 HUMAN PRESCRIPTION DRUG Nutropin AQ NuSpin 5 somatropin INJECTION, SOLUTION SUBCUTANEOUS 19951229 NDA NDA020522 Genentech, Inc. SOMATROPIN 5 mg/2mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] N 20191231 50242-076_f2b6bd04-6837-44a6-a785-12c2138e5657 50242-076 HUMAN PRESCRIPTION DRUG Nutropin AQ NuSpin 20 somatropin INJECTION, SOLUTION SUBCUTANEOUS 19951229 NDA NDA020522 Genentech, Inc. SOMATROPIN 20 mg/2mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] N 20191231 50242-080_3324ea2f-1ca4-403c-8049-61108762e7c7 50242-080 HUMAN PRESCRIPTION DRUG LUCENTIS RANIBIZUMAB INJECTION, SOLUTION INTRAVITREAL 20060630 BLA BLA125156 Genentech, Inc. RANIBIZUMAB 10 mg/mL Vascular Endothelial Growth Factor Inhibitors [MoA],Vascular Endothelial Growth Factor Inhibitor [EPC] N 20181231 50242-082_3324ea2f-1ca4-403c-8049-61108762e7c7 50242-082 HUMAN PRESCRIPTION DRUG LUCENTIS RANIBIZUMAB INJECTION, SOLUTION INTRAVITREAL 20120810 BLA BLA125156 Genentech, Inc. RANIBIZUMAB 6 mg/mL Vascular Endothelial Growth Factor Inhibitors [MoA],Vascular Endothelial Growth Factor Inhibitor [EPC] N 20181231 50242-085_86494e0d-6fb3-41d4-9894-c3d30ea9ba39 50242-085 HUMAN PRESCRIPTION DRUG Activase Alteplase KIT 19871113 BLA BLA103172 Genentech, Inc. N 20181231 50242-087_9524befe-98f1-4068-8352-a0006d5d516a 50242-087 HUMAN PRESCRIPTION DRUG KADCYLA ADO-TRASTUZUMAB EMTANSINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130222 BLA BLA125427 Genentech, Inc. ADO-TRASTUZUMAB EMTANSINE 20 mg/mL N 20181231 50242-088_9524befe-98f1-4068-8352-a0006d5d516a 50242-088 HUMAN PRESCRIPTION DRUG KADCYLA ADO-TRASTUZUMAB EMTANSINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130222 BLA BLA125427 Genentech, Inc. ADO-TRASTUZUMAB EMTANSINE 20 mg/mL N 20181231 50242-090_53c0f611-92af-48d1-a4a8-c449d4898b2e 50242-090 HUMAN PRESCRIPTION DRUG ZELBORAF Vemurafenib TABLET, FILM COATED ORAL 20110817 NDA NDA202429 Genentech, Inc. VEMURAFENIB 240 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50242-100_9dbc2667-1708-4c75-84bb-169c16a0165c 50242-100 HUMAN PRESCRIPTION DRUG Pulmozyme dornase alfa SOLUTION RESPIRATORY (INHALATION) 19931230 BLA BLA103532 Genentech, Inc. DORNASE ALFA 1 mg/mL Decreased Respiratory Secretion Viscosity [PE],Deoxyribonuclease I [Chemical/Ingredient],Recombinant Human Deoxyribonuclease 1 [EPC],Recombinant Proteins [Chemical/Ingredient] N 20191231 50242-108_c64a8797-07c1-4c1f-a6bb-3cd44a2a5de6 50242-108 HUMAN PRESCRIPTION DRUG Rituxan Hycela rituximab and hyaluronidase INJECTION, SOLUTION SUBCUTANEOUS 20170622 BLA BLA761064 Genentech, Inc. RITUXIMAB; HYALURONIDASE 120; 2000 mg/mL; U/mL CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC],Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] N 20181231 50242-109_c64a8797-07c1-4c1f-a6bb-3cd44a2a5de6 50242-109 HUMAN PRESCRIPTION DRUG Rituxan Hycela rituximab and hyaluronidase INJECTION, SOLUTION SUBCUTANEOUS 20170622 BLA BLA761064 Genentech, Inc. RITUXIMAB; HYALURONIDASE 120; 2000 mg/mL; U/mL CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC],Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] N 20181231 50242-120_ae3589a5-e6bb-48d5-abc1-d94d73219d82 50242-120 HUMAN PRESCRIPTION DRUG TNKase tenecteplase KIT 20000602 BLA BLA103909 Genentech, Inc. N 20181231 50242-121_dd00149f-3a11-46f0-9b2b-c18733fdcc18 50242-121 HUMAN PRESCRIPTION DRUG ESBRIET PIRFENIDONE CAPSULE ORAL 20141015 NDA NDA022535 Genentech, Inc. PIRFENIDONE 267 mg/1 Pyridone [EPC],Pyridones [Chemical/Ingredient] N 20181231 50242-122_dd00149f-3a11-46f0-9b2b-c18733fdcc18 50242-122 HUMAN PRESCRIPTION DRUG ESBRIET PIRFENIDONE TABLET, COATED ORAL 20170111 NDA NDA208780 Genentech, Inc. PIRFENIDONE 267 mg/1 Pyridone [EPC],Pyridones [Chemical/Ingredient] N 20181231 50242-123_dd00149f-3a11-46f0-9b2b-c18733fdcc18 50242-123 HUMAN PRESCRIPTION DRUG ESBRIET PIRFENIDONE TABLET, COATED ORAL 20170111 NDA NDA208780 Genentech, Inc. PIRFENIDONE 801 mg/1 Pyridone [EPC],Pyridones [Chemical/Ingredient] N 20181231 50242-130_dd264b8b-a151-4ed6-87de-526b302069ca 50242-130 HUMAN PRESCRIPTION DRUG ALECENSA ALECTINIB HYDROCHLORIDE CAPSULE ORAL 20151211 NDA NDA208434 Genentech, Inc. ALECTINIB HYDROCHLORIDE 150 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA] N 20181231 50242-132_c6f5f327-583d-45a8-9a71-2e8c50588ec9 50242-132 HUMAN PRESCRIPTION DRUG Herceptin Trastuzumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170210 BLA BLA103792 Genentech, Inc. TRASTUZUMAB 150 mg/7.4mL HER2 Receptor Antagonist [EPC],HER2/Neu/cerbB2 Antagonists [MoA] N 20181231 50242-134_c6f5f327-583d-45a8-9a71-2e8c50588ec9 50242-134 HUMAN PRESCRIPTION DRUG Herceptin Trastuzumab KIT 19980925 BLA BLA103792 Genentech, Inc. N 20181231 50242-135_b14d7563-8e1d-493e-8ef1-25fdbc8ceef6 50242-135 HUMAN PRESCRIPTION DRUG ACTEMRA tocilizumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100108 BLA BLA125276 Genentech, Inc. TOCILIZUMAB 20 mg/mL Interleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC] N 20181231 50242-136_b14d7563-8e1d-493e-8ef1-25fdbc8ceef6 50242-136 HUMAN PRESCRIPTION DRUG ACTEMRA tocilizumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100108 BLA BLA125276 Genentech, Inc. TOCILIZUMAB 20 mg/mL Interleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC] N 20181231 50242-137_b14d7563-8e1d-493e-8ef1-25fdbc8ceef6 50242-137 HUMAN PRESCRIPTION DRUG ACTEMRA tocilizumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100108 BLA BLA125276 Genentech, Inc. TOCILIZUMAB 20 mg/mL Interleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC] N 20181231 50242-138_b14d7563-8e1d-493e-8ef1-25fdbc8ceef6 50242-138 HUMAN PRESCRIPTION DRUG Actemra tocilizumab INJECTION, SOLUTION SUBCUTANEOUS 20131021 BLA BLA125472 Genentech, Inc. TOCILIZUMAB 180 mg/mL Interleukin 6 Receptor Antagonists [MoA],Interleukin-6 Receptor Antagonist [EPC] N 20181231 50242-140_26783c68-eef3-4b39-940f-267e5bd472ad 50242-140 HUMAN PRESCRIPTION DRUG ERIVEDGE vismodegib CAPSULE ORAL 20120130 NDA NDA203388 Genentech, Inc. VISMODEGIB 150 mg/1 Hedgehog Pathway Inhibitor [EPC],Smoothened Receptor Antagonists [MoA] N 20181231 50242-145_eb3d4df5-0dd3-4db7-af73-a38e1a222a0f 50242-145 HUMAN PRESCRIPTION DRUG PERJETA Pertuzumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20120608 BLA BLA125409 Genentech, Inc. PERTUZUMAB 30 mg/mL HER2 Receptor Antagonist [EPC],HER2/Neu/cerbB2 Antagonists [MoA] N 20181231 50242-150_11462749-5f11-4524-99e6-6fe0d6b7f7f9 50242-150 HUMAN PRESCRIPTION DRUG OCREVUS ocrelizumab INJECTION INTRAVENOUS 20170328 BLA BLA761053 Genentech, Inc. OCRELIZUMAB 300 mg/10mL CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC],Antibodies, Monoclonal [Chemical/Ingredient],Antibodies, Monoclonal, Humanized [Chemical/Ingredient] N 20181231 50242-333_c6f5f327-583d-45a8-9a71-2e8c50588ec9 50242-333 HUMAN PRESCRIPTION DRUG Herceptin Trastuzumab KIT 19980925 BLA BLA103792 Genentech, Inc. N 20181231 50242-717_174ba6a9-f796-4003-9cf9-1dede66d5649 50242-717 HUMAN PRESCRIPTION DRUG Cotellic COBIMETINIB TABLET, FILM COATED ORAL 20151110 NDA NDA206192 Genentech, Inc. COBIMETINIB FUMARATE 20 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA] N 20191231 50242-917_74b9753b-3449-421f-84c1-3cd15ed231fc 50242-917 HUMAN PRESCRIPTION DRUG TECENTRIQ atezolizumab INJECTION, SOLUTION INTRAVENOUS 20160518 BLA BLA761034 Genentech, Inc. ATEZOLIZUMAB 1200 mg/20mL Programmed Death Receptor-1 Blocking Antibody [EPC],Programmed Death Receptor-1-directed Antibody Interactions [MoA],Antibodies, Monoclonal, Humanized [Chemical/Ingredient],Antibodies, Monoclonal [Chemical/Ingredient],Antibodies [Chemical/Ingredient] N 20181231 50242-920_23ff602d-4ab1-435b-b0ed-cbeafe34fe66 50242-920 HUMAN PRESCRIPTION DRUG Hemlibra emicizumab INJECTION, SOLUTION SUBCUTANEOUS 20171116 BLA BLA761083 Genentech, Inc. EMICIZUMAB 30 mg/mL N 20181231 50242-921_23ff602d-4ab1-435b-b0ed-cbeafe34fe66 50242-921 HUMAN PRESCRIPTION DRUG Hemlibra emicizumab INJECTION, SOLUTION SUBCUTANEOUS 20171116 BLA BLA761083 Genentech, Inc. EMICIZUMAB 150 mg/mL N 20181231 50242-922_23ff602d-4ab1-435b-b0ed-cbeafe34fe66 50242-922 HUMAN PRESCRIPTION DRUG Hemlibra emicizumab INJECTION, SOLUTION SUBCUTANEOUS 20171116 BLA BLA761083 Genentech, Inc. EMICIZUMAB 150 mg/mL N 20181231 50242-923_23ff602d-4ab1-435b-b0ed-cbeafe34fe66 50242-923 HUMAN PRESCRIPTION DRUG Hemlibra emicizumab INJECTION, SOLUTION SUBCUTANEOUS 20171116 BLA BLA761083 Genentech, Inc. EMICIZUMAB 150 mg/mL N 20181231 50254-365_bff3b23b-ffe9-4644-a266-65e4ac412389 50254-365 HUMAN OTC DRUG Bea-Silky ALCOHOL LOTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333E Beaver Research Company ALCOHOL .7 mL/mL N 20181231 50254-773_e3a89587-cb6a-4b7b-9a02-442edb088622 50254-773 HUMAN OTC DRUG Germ Bullet ALCOHOL AEROSOL, FOAM TOPICAL 20091031 OTC MONOGRAPH NOT FINAL part333 Beaver Research Company ALCOHOL 620 mg/g E 20171231 50260-200_4a6a41af-8bad-4153-a8c0-b410f1455fad 50260-200 HUMAN OTC DRUG HAND SANITIZER HAND SANITIZER GEL PERCUTANEOUS 20100201 OTC MONOGRAPH FINAL part348 Fercy Personal Care Products Co Limited ALCOHOL 62 mL/100mL E 20171231 50260-300_e8881780-74bb-481a-b58a-31b9d2a04e3a 50260-300 HUMAN OTC DRUG HAND SANITIZER ALCOHOL FREE ALCOHOL FREE HAND SANITIZER GEL PERCUTANEOUS 20100406 OTC MONOGRAPH FINAL part348 Fercy Personal Care Products Co Limited TRICLOSAN 2 mL/100mL E 20171231 50260-500_f8575e6b-5930-40de-bf98-0f141fc508c8 50260-500 HUMAN OTC DRUG NON ALCOHOL HAND SANITIZER Benzalkonium Chloride GEL TOPICAL 20101113 OTC MONOGRAPH NOT FINAL part333A Fercy Personal Care Products Co Limited BENZALKONIUM CHLORIDE .1 mL/100mL E 20171231 50260-800_6033f19a-bfc6-494f-89ca-efb8b0a7ed8d 50260-800 HUMAN OTC DRUG Lip Balm SPF 15 Octinoxate OXYBENZONE OINTMENT TOPICAL 20101209 OTC MONOGRAPH FINAL part352 Fercy Personal Care Products Co Limited OXYBENZONE; OCTINOXATE 3; 7.5 g/100g; g/100g E 20171231 50268-050_cdf79b36-3c95-a47d-6338-249e8f647049 50268-050 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091201 ANDA ANDA075047 AvPAK ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50268-052_3311e81a-65bc-6320-1927-67efcd86d1d0 50268-052 HUMAN OTC DRUG Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160307 ANDA ANDA076200 AvPAK ACETAMINOPHEN 650 mg/1 N 20181231 50268-053_47483bc6-547e-128c-c513-22d09bede6b8 50268-053 HUMAN OTC DRUG EXTRA PAIN RELIEF ACETAMINOPHEN, ASPIRIN AND CAFFEINE TABLET, FILM COATED ORAL 20160823 OTC MONOGRAPH NOT FINAL part343 AvPAK ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 50268-060_8e1ae7dd-3bb1-9826-9ed1-b832a2b18479 50268-060 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20130502 ANDA ANDA075090 AvPAK ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50268-061_d7b2d8a6-05fb-218e-81c7-09a02b6a0605 50268-061 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 AvPAK ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50268-062_d7b2d8a6-05fb-218e-81c7-09a02b6a0605 50268-062 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20140718 ANDA ANDA075382 AvPAK ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50268-063_b2a8587b-f788-adfd-5f49-986962c7f91d 50268-063 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20160801 ANDA ANDA075798 AvPAK ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 50268-064_b2a8587b-f788-adfd-5f49-986962c7f91d 50268-064 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20160801 ANDA ANDA075798 AvPAK ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 50268-069_e11af652-e90e-4f05-b165-948e3703897c 50268-069 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140328 ANDA ANDA078720 AvPAK AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 50268-071_c606b6c4-5ced-7e57-742c-a905757efc69 50268-071 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL 20130128 ANDA ANDA079133 AvPAK AMILORIDE HYDROCHLORIDE 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 50268-083_441d8ee7-7ce0-cc11-574b-1a69aafd8acc 50268-083 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140110 ANDA ANDA078552 AvPAK AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50268-084_441d8ee7-7ce0-cc11-574b-1a69aafd8acc 50268-084 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140110 ANDA ANDA078552 AvPAK AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50268-085_441d8ee7-7ce0-cc11-574b-1a69aafd8acc 50268-085 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140110 ANDA ANDA078552 AvPAK AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50268-087_cf91b4e0-648d-9715-7f2a-f176968348a1 50268-087 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160428 ANDA ANDA205064 AvPAK ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-088_cf91b4e0-648d-9715-7f2a-f176968348a1 50268-088 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160428 ANDA ANDA205064 AvPAK ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-089_cf91b4e0-648d-9715-7f2a-f176968348a1 50268-089 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160428 ANDA ANDA205064 AvPAK ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-090_cf91b4e0-648d-9715-7f2a-f176968348a1 50268-090 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160428 ANDA ANDA205064 AvPAK ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-091_cf91b4e0-648d-9715-7f2a-f176968348a1 50268-091 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160428 ANDA ANDA205064 AvPAK ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-092_cf91b4e0-648d-9715-7f2a-f176968348a1 50268-092 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160428 ANDA ANDA205064 AvPAK ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-093_95de7ccb-17d3-8662-e525-ece93513d0e4 50268-093 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160624 ANDA ANDA090548 AvPAK ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-094_95de7ccb-17d3-8662-e525-ece93513d0e4 50268-094 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160624 ANDA ANDA090548 AvPAK ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-095_95de7ccb-17d3-8662-e525-ece93513d0e4 50268-095 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160624 ANDA ANDA090548 AvPAK ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-096_95de7ccb-17d3-8662-e525-ece93513d0e4 50268-096 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160624 ANDA ANDA090548 AvPAK ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-102_98ab4c37-72f9-61d0-25b9-cb41c956c9e1 50268-102 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20141106 ANDA ANDA077883 AvPAK BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 50268-103_d985f9dd-9e10-c394-b6d3-db58f1372976 50268-103 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20161116 ANDA ANDA065507 AvPAK AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50268-104_d985f9dd-9e10-c394-b6d3-db58f1372976 50268-104 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20161116 ANDA ANDA065509 AvPAK AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50268-109_dfbf6fef-a824-25a2-6006-083e52f01829 50268-109 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20140414 ANDA ANDA076820 AvPAK BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50268-110_dfbf6fef-a824-25a2-6006-083e52f01829 50268-110 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20140415 ANDA ANDA076820 AvPAK BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50268-111_dfbf6fef-a824-25a2-6006-083e52f01829 50268-111 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20140415 ANDA ANDA076820 AvPAK BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50268-112_dfbf6fef-a824-25a2-6006-083e52f01829 50268-112 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20140415 ANDA ANDA076820 AvPAK BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50268-113_9fe2cddf-ecdc-fb80-984a-03e3793f51cc 50268-113 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20070111 ANDA ANDA040855 AvPAK BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 50268-114_9fe2cddf-ecdc-fb80-984a-03e3793f51cc 50268-114 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20070111 ANDA ANDA040855 AvPAK BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 50268-115_f1bfb708-4a67-14bb-abd9-b1f7586ca9d2 50268-115 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20150325 ANDA ANDA090294 AvPAK BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 50268-116_f1bfb708-4a67-14bb-abd9-b1f7586ca9d2 50268-116 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20150325 ANDA ANDA090294 AvPAK BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 50268-117_f1bfb708-4a67-14bb-abd9-b1f7586ca9d2 50268-117 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20150325 ANDA ANDA090294 AvPAK BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 50268-139_2ddeef14-69e8-4b8b-9415-a6dfade75aec 50268-139 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 20170721 ANDA ANDA089718 AvPAK BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 50268-141_b2b86023-8fbc-af58-11cf-47466f4c9e9b 50268-141 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161004 ANDA ANDA077284 AvPAK BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50268-142_c82adb13-5a84-47af-a860-a0ec25579da3 50268-142 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20170802 ANDA ANDA076143 AvPAK BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50268-143_c82adb13-5a84-47af-a860-a0ec25579da3 50268-143 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20170802 ANDA ANDA076143 AvPAK BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50268-144_2811c515-e6ba-e17b-77ca-34a7bcc55f00 50268-144 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20161205 ANDA ANDA203136 AvPAK BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 50268-145_2811c515-e6ba-e17b-77ca-34a7bcc55f00 50268-145 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20161205 ANDA ANDA203136 AvPAK BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 50268-148_df406483-2516-b9e3-ed84-99f123952b23 50268-148 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20151116 ANDA ANDA201658 AvPAK CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 50268-151_f2ee2e63-c60f-c44f-ea62-5fc6d1a6985c 50268-151 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140912 ANDA ANDA090836 AvPAK CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50268-152_f2ee2e63-c60f-c44f-ea62-5fc6d1a6985c 50268-152 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140912 ANDA ANDA090836 AvPAK CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50268-176_a191fa25-f363-93b4-d1f4-34e53715ba0b 50268-176 HUMAN PRESCRIPTION DRUG cilostazol cilostazol TABLET ORAL 20161018 ANDA ANDA077030 AvPAK CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 50268-177_a191fa25-f363-93b4-d1f4-34e53715ba0b 50268-177 HUMAN PRESCRIPTION DRUG cilostazol cilostazol TABLET ORAL 20161018 ANDA ANDA077030 AvPAK CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 50268-178_4ae1f5a9-0b00-a540-0757-e90d43e728cc 50268-178 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20161010 ANDA ANDA065489 AvPAK CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50268-179_4ae1f5a9-0b00-a540-0757-e90d43e728cc 50268-179 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20161010 ANDA ANDA065489 AvPAK CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50268-180_05880c4a-3c68-709f-c917-6016b79cf2a0 50268-180 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140715 ANDA ANDA065442 AvPAK CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 50268-181_05880c4a-3c68-709f-c917-6016b79cf2a0 50268-181 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140715 ANDA ANDA065442 AvPAK CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 50268-190_65575bd1-0a0a-cf26-854f-14d9958b12cc 50268-190 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20140610 ANDA ANDA090478 AvPAK CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50268-218_7143241d-539b-b917-6625-dcbd18e821fe 50268-218 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20151125 ANDA ANDA078355 AvPAK DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 50268-220_21174971-6cf2-c95c-1311-53db61b8fd62 50268-220 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20130724 ANDA ANDA076470 AvPAK DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 50268-221_21174971-6cf2-c95c-1311-53db61b8fd62 50268-221 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20130724 ANDA ANDA076470 AvPAK DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 50268-258_d173c36f-0b6c-294d-1e07-924fc4166f47 50268-258 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium CAPSULE, COATED PELLETS ORAL 20160714 ANDA ANDA078919 AvPAK DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50268-266_0561f5a6-5e1d-481c-928b-48e7333bc757 50268-266 HUMAN OTC DRUG Docusate Calcium 240 mg sodium free Docusate Calcium CAPSULE, LIQUID FILLED ORAL 20170517 OTC MONOGRAPH NOT FINAL part334 AvPAK DOCUSATE CALCIUM 240 mg/1 N 20181231 50268-268_af9d09ca-81b6-4766-8ae5-7a5c3ff5d2b7 50268-268 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20170517 OTC MONOGRAPH NOT FINAL part334 AvPAK DOCUSATE SODIUM 250 mg/1 N 20181231 50268-273_1eb1010e-f264-436a-977c-06173ad96453 50268-273 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20170125 ANDA ANDA076161 AvPAK DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50268-274_1eb1010e-f264-436a-977c-06173ad96453 50268-274 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20170125 ANDA ANDA076161 AvPAK DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50268-275_1eb1010e-f264-436a-977c-06173ad96453 50268-275 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20170125 ANDA ANDA076161 AvPAK DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50268-276_1eb1010e-f264-436a-977c-06173ad96453 50268-276 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20170125 ANDA ANDA076161 AvPAK DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50268-277_7bd8f46f-3bd1-4409-931c-d3b3228410d7 50268-277 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20140605 ANDA ANDA062675 AvPAK DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 50268-278_7bd8f46f-3bd1-4409-931c-d3b3228410d7 50268-278 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20140605 ANDA ANDA062676 AvPAK DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 50268-279_7bd8f46f-3bd1-4409-931c-d3b3228410d7 50268-279 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20140605 ANDA ANDA062677 AvPAK DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 50268-282_0790e4d5-78ca-4b3a-be02-3a543a2ccc92 50268-282 HUMAN PRESCRIPTION DRUG Dutasteride Dutasteride CAPSULE, LIQUID FILLED ORAL 20171107 ANDA ANDA206574 AvPAK DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 50268-283_dc124693-8ee8-4769-9c7e-abbc4b3be08a 50268-283 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20170419 ANDA ANDA090778 AvPAK DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-284_dc124693-8ee8-4769-9c7e-abbc4b3be08a 50268-284 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20170419 ANDA ANDA090778 AvPAK DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-285_dc124693-8ee8-4769-9c7e-abbc4b3be08a 50268-285 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20170419 ANDA ANDA090778 AvPAK DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-290_a178389c-c1b5-0dea-32b8-09ff41700cd8 50268-290 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20140212 ANDA ANDA040114 AvPAK ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50268-291_a178389c-c1b5-0dea-32b8-09ff41700cd8 50268-291 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20140212 ANDA ANDA040114 AvPAK ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50268-292_a178389c-c1b5-0dea-32b8-09ff41700cd8 50268-292 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20140212 ANDA ANDA040114 AvPAK ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50268-295_61396c8d-08a0-8c3a-dd6c-b384e392cdd5 50268-295 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20161205 ANDA ANDA203437 AvPAK ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 50268-303_ef8b2ebc-08d8-6596-d328-5de0b0967c33 50268-303 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20141006 ANDA ANDA075805 AvPAK FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50268-304_ef8b2ebc-08d8-6596-d328-5de0b0967c33 50268-304 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20141006 ANDA ANDA075805 AvPAK FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50268-305_79438060-ffdd-b240-40e5-f4a4320395a0 50268-305 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20130516 ANDA ANDA201022 AvPAK FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50268-306_79438060-ffdd-b240-40e5-f4a4320395a0 50268-306 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20130516 ANDA ANDA201022 AvPAK FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50268-307_79438060-ffdd-b240-40e5-f4a4320395a0 50268-307 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20130516 ANDA ANDA201022 AvPAK FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50268-309_0d8bb480-6505-4231-82b0-74af2bc860a5 50268-309 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20170110 ANDA ANDA075868 AvPAK FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 50268-310_4b8695f7-28fe-d02c-e58d-b8b632325ef4 50268-310 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160919 ANDA ANDA090856 AvPAK FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 50268-311_4b8695f7-28fe-d02c-e58d-b8b632325ef4 50268-311 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160919 ANDA ANDA090856 AvPAK FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 50268-312_6d78d012-2718-4b88-2744-cce59be587d5 50268-312 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20150813 ANDA ANDA076509 AvPAK FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 50268-313_6d78d012-2718-4b88-2744-cce59be587d5 50268-313 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20150813 ANDA ANDA076509 AvPAK FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 50268-315_0601e8f9-6e83-48de-b0e7-a1288a961a14 50268-315 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20170802 ANDA ANDA202039 AvPAK FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 50268-316_3abfd7f0-d7ca-5bbc-9a16-f940104311f7 50268-316 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20160816 ANDA ANDA202039 AvPAK FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 50268-320_b664da33-623a-9eb8-ade8-62edad88b193 50268-320 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20150209 ANDA ANDA075442 AvPAK FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] N 20181231 50268-321_b664da33-623a-9eb8-ade8-62edad88b193 50268-321 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20150209 ANDA ANDA075442 AvPAK FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 50268-322_b664da33-623a-9eb8-ade8-62edad88b193 50268-322 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20150209 ANDA ANDA075442 AvPAK FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 50268-323_f924ee84-d6c4-6f5b-2944-e9003b044e9e 50268-323 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20070328 ANDA ANDA077914 AvPAK FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 50268-324_267b9e91-a7ba-ee5a-508a-9a6182160831 50268-324 HUMAN PRESCRIPTION DRUG Flavoxate Hydrochloride Flavoxate Hydrochloride TABLET ORAL 20121130 ANDA ANDA076835 AvPAK FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 50268-330_82349812-2737-4778-b9a6-593c025217ff 50268-330 HUMAN PRESCRIPTION DRUG FLUDROCORTISONE ACETATE FLUDROCORTISONE ACETATE TABLET ORAL 20110801 ANDA ANDA040431 AvPAK FLUDROCORTISONE ACETATE .1 mg/1 N 20181231 50268-333_03472d45-03de-de19-7864-34619df38053 50268-333 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20140820 ANDA ANDA078619 AvPAK FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-334_03472d45-03de-de19-7864-34619df38053 50268-334 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20140820 ANDA ANDA078619 AvPAK FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-335_03472d45-03de-de19-7864-34619df38053 50268-335 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20140820 ANDA ANDA078619 AvPAK FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-337_ec761b6a-454e-1007-f21a-5a126c9259a1 50268-337 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20160909 ANDA ANDA077731 AvPAK FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 50268-339_ec761b6a-454e-1007-f21a-5a126c9259a1 50268-339 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20160909 ANDA ANDA077731 AvPAK FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 50268-345_0d12eeea-3a42-8630-7131-0873fb2ebae4 50268-345 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20050722 ANDA ANDA040625 AvPAK FOLIC ACID 1 mg/1 N 20181231 50268-348_6b913939-59ec-5129-28a2-cd1a42f788c9 50268-348 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20160310 ANDA ANDA090007 AvPAK GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-349_6b913939-59ec-5129-28a2-cd1a42f788c9 50268-349 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20160311 ANDA ANDA090007 AvPAK GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-350_99ab0a7a-f31c-4a50-f8a6-92b1413dfd30 50268-350 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20140710 ANDA ANDA077836 AvPAK GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 50268-351_7d59998a-6be4-b21f-ba4d-4353cb2055d5 50268-351 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 20150213 ANDA ANDA202764 AvPAK GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-352_7d59998a-6be4-b21f-ba4d-4353cb2055d5 50268-352 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 20150213 ANDA ANDA202764 AvPAK GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-353_6286af18-5399-c590-e053-2a91aa0ac96a 50268-353 HUMAN OTC DRUG Germ Bloc Hand Sanitizer Benzalkonium Chloride LOTION TOPICAL 20160711 OTC MONOGRAPH NOT FINAL part333A AvPAK BENZALKONIUM CHLORIDE .0013 g/mL N 20191231 50268-354_d309dd1a-054d-4910-913d-b6dfb33e803a 50268-354 HUMAN OTC DRUG Germ Bloc Hand Sanitizer Foam Peppermint Benzalkonium Chloride LIQUID TOPICAL 20160711 OTC MONOGRAPH NOT FINAL part333A AvPAK BENZALKONIUM CHLORIDE .001 g/mL N 20181231 50268-374_2e68061b-92b8-418b-91a6-769a20c3b29b 50268-374 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine TABLET ORAL 20170607 ANDA ANDA075109 AvPAK GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50268-382_cac242df-2e95-329e-65c2-62b3bc202d81 50268-382 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET ORAL 20161004 OTC MONOGRAPH FINAL part341 AvPAK GUAIFENESIN 200 mg/1 N 20181231 50268-383_201d692b-f304-2f3d-c615-35b1d8e985ce 50268-383 HUMAN OTC DRUG MUCOSA GUAIFENESIN TABLET ORAL 20150311 OTC MONOGRAPH FINAL part341 AvPAK GUAIFENESIN 400 mg/1 N 20181231 50268-400_f15d499b-3db8-0d9a-2a6f-9c96e4164915 50268-400 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161028 ANDA ANDA040746 AvPAK HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50268-401_92e8fdac-0738-bba8-d5ae-b5a580cdbadd 50268-401 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140915 ANDA ANDA040736 AvPAK HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50268-402_92e8fdac-0738-bba8-d5ae-b5a580cdbadd 50268-402 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140915 ANDA ANDA040746 AvPAK HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50268-411_b9122d01-3d27-4fbb-ae50-8f8e54c1a767 50268-411 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate Hydrocortisone Acetate SUPPOSITORY RECTAL 20170117 UNAPPROVED DRUG OTHER AvPAK HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50268-426_a5a537f2-b50a-484a-b6b4-2f2be89853f4 50268-426 HUMAN PRESCRIPTION DRUG Imatinib Mesylate Imatinib Mesylate TABLET, FILM COATED ORAL 20170824 ANDA ANDA079179 AvPAK IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 50268-427_a5a537f2-b50a-484a-b6b4-2f2be89853f4 50268-427 HUMAN PRESCRIPTION DRUG Imatinib Mesylate Imatinib Mesylate TABLET, FILM COATED ORAL 20170824 ANDA ANDA079179 AvPAK IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 50268-430_7edff194-3cbc-944e-5483-919722f18952 50268-430 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20150519 ANDA ANDA091240 AvPAK INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50268-431_7edff194-3cbc-944e-5483-919722f18952 50268-431 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20150520 ANDA ANDA091240 AvPAK INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50268-432_810c0aeb-4b55-9fd0-46cc-5ae2cf24c3de 50268-432 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20150915 ANDA ANDA201807 AvPAK INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50268-440_5818deff-4df8-29ed-d009-6e8a407133f5 50268-440 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20151027 ANDA ANDA202910 AvPAK IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-441_5818deff-4df8-29ed-d009-6e8a407133f5 50268-441 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20151027 ANDA ANDA202910 AvPAK IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-442_5818deff-4df8-29ed-d009-6e8a407133f5 50268-442 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20151027 ANDA ANDA202910 AvPAK IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-447_34c3922e-3bb2-4367-886d-323f39c0a0e2 50268-447 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20160913 ANDA ANDA086923 AvPAK ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50268-448_34c3922e-3bb2-4367-886d-323f39c0a0e2 50268-448 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20170606 ANDA ANDA086925 AvPAK ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50268-449_34c3922e-3bb2-4367-886d-323f39c0a0e2 50268-449 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20160913 ANDA ANDA087537 AvPAK ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50268-451_df526d96-1920-ac40-2ec2-84b34d2cc8d3 50268-451 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20121213 ANDA ANDA075155 AvPAK ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50268-452_df526d96-1920-ac40-2ec2-84b34d2cc8d3 50268-452 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20121213 ANDA ANDA075155 AvPAK ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50268-453_df526d96-1920-ac40-2ec2-84b34d2cc8d3 50268-453 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20140428 ANDA ANDA075155 AvPAK ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50268-454_35cacb47-8c18-14b0-8c68-cc96f03cc318 50268-454 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20140106 ANDA ANDA077317 AvPAK ISRADIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50268-455_35cacb47-8c18-14b0-8c68-cc96f03cc318 50268-455 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20140106 ANDA ANDA077317 AvPAK ISRADIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50268-459_209de052-4981-2ad4-ccc8-63740c10f988 50268-459 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20150730 ANDA ANDA203277 AvPAK LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 50268-460_209de052-4981-2ad4-ccc8-63740c10f988 50268-460 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20150730 ANDA ANDA203277 AvPAK LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 50268-461_28d586f4-cf55-257a-768b-e658901becc7 50268-461 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20150625 ANDA ANDA079132 AvPAK LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50268-462_28d586f4-cf55-257a-768b-e658901becc7 50268-462 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20150625 ANDA ANDA079132 AvPAK LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50268-463_28d586f4-cf55-257a-768b-e658901becc7 50268-463 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20150625 ANDA ANDA079132 AvPAK LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50268-464_28d586f4-cf55-257a-768b-e658901becc7 50268-464 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20150625 ANDA ANDA079132 AvPAK LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50268-465_7ce84420-72fa-046d-c224-2c702fab5b28 50268-465 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20160714 ANDA ANDA202366 AvPAK LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 50268-466_7ce84420-72fa-046d-c224-2c702fab5b28 50268-466 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20160714 ANDA ANDA202366 AvPAK LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 50268-467_2c5275b7-cc65-22fa-9f8b-add8bc6ebaa5 50268-467 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090320 ANDA ANDA077319 AvPAK LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-468_2c5275b7-cc65-22fa-9f8b-add8bc6ebaa5 50268-468 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090320 ANDA ANDA077319 AvPAK LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-469_2c5275b7-cc65-22fa-9f8b-add8bc6ebaa5 50268-469 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090320 ANDA ANDA077319 AvPAK LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-471_b8421a13-2148-a9bd-a21f-234e981eaa60 50268-471 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20151231 ANDA ANDA205517 AvPAK LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 50268-472_c9b0f7bd-8202-40b6-850d-0a2b50b9f2a5 50268-472 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20170613 ANDA ANDA078106 AvPAK LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-473_c9b0f7bd-8202-40b6-850d-0a2b50b9f2a5 50268-473 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20170613 ANDA ANDA078106 AvPAK LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-474_c9b0f7bd-8202-40b6-850d-0a2b50b9f2a5 50268-474 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20170613 ANDA ANDA078106 AvPAK LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-475_c9b0f7bd-8202-40b6-850d-0a2b50b9f2a5 50268-475 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20170613 ANDA ANDA078106 AvPAK LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-488_b08e530c-3098-1442-f395-0836379502ec 50268-488 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20160311 ANDA ANDA076471 AvPAK LORATADINE 10 mg/1 N 20181231 50268-510_0e02b2e2-5fb5-89cc-d89d-4bb813a0e946 50268-510 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140429 ANDA ANDA075991 AvPAK LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-511_0e02b2e2-5fb5-89cc-d89d-4bb813a0e946 50268-511 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140429 ANDA ANDA075991 AvPAK LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-512_0e02b2e2-5fb5-89cc-d89d-4bb813a0e946 50268-512 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140429 ANDA ANDA075991 AvPAK LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-513_0b997049-21d2-5bf9-ed1c-eb2a098af150 50268-513 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20140328 ANDA ANDA090528 AvPAK HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-514_0b997049-21d2-5bf9-ed1c-eb2a098af150 50268-514 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20140328 ANDA ANDA090528 AvPAK HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-515_0b997049-21d2-5bf9-ed1c-eb2a098af150 50268-515 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20140328 ANDA ANDA090528 AvPAK HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-516_07da41d7-f958-dfe4-9411-77182e8b9fd0 50268-516 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20140327 ANDA ANDA090467 AvPAK LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-517_07da41d7-f958-dfe4-9411-77182e8b9fd0 50268-517 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20140327 ANDA ANDA090467 AvPAK LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-518_07da41d7-f958-dfe4-9411-77182e8b9fd0 50268-518 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20140327 ANDA ANDA090467 AvPAK LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-522_fa653e96-da55-1353-94d3-3a94a9ab4192 50268-522 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20130808 ANDA ANDA201451 AvPAK MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 50268-523_fa653e96-da55-1353-94d3-3a94a9ab4192 50268-523 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20130808 ANDA ANDA201451 AvPAK MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 50268-525_301def14-decf-21dc-8240-4f07b16ecbc2 50268-525 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20121009 ANDA ANDA077918 AvPAK MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50268-526_301def14-decf-21dc-8240-4f07b16ecbc2 50268-526 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20121009 ANDA ANDA077918 AvPAK MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50268-530_f75efb73-8520-facd-cee7-b074172c3944 50268-530 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20150313 ANDA ANDA203399 AvPAK METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 50268-531_b279608d-85b8-967c-4be1-78d2292f171c 50268-531 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 AvPAK METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50268-532_b279608d-85b8-967c-4be1-78d2292f171c 50268-532 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141112 ANDA ANDA078596 AvPAK METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50268-536_de659d15-2863-3d4f-063c-a51d6a6b9623 50268-536 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20141020 ANDA ANDA086989 AvPAK METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50268-537_de659d15-2863-3d4f-063c-a51d6a6b9623 50268-537 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20141020 ANDA ANDA086988 AvPAK METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50268-538_68e87a61-e8e1-3d84-b586-ab4accefdf84 50268-538 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20161108 ANDA ANDA070035 AvPAK METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 50268-539_68e87a61-e8e1-3d84-b586-ab4accefdf84 50268-539 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20161108 ANDA ANDA070044 AvPAK METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 50268-564_04e9adc6-4572-204f-3143-a900d4d0694b 50268-564 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20110817 ANDA ANDA076449 AvPAK MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 50268-565_04e9adc6-4572-204f-3143-a900d4d0694b 50268-565 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20110817 ANDA ANDA076449 AvPAK MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 50268-566_04e9adc6-4572-204f-3143-a900d4d0694b 50268-566 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20110817 ANDA ANDA076449 AvPAK MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 50268-567_23891007-31e1-556b-5c88-7475a15c8899 50268-567 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20150128 ANDA ANDA063181 AvPAK MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 50268-569_23891007-31e1-556b-5c88-7475a15c8899 50268-569 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20141107 ANDA ANDA063065 AvPAK MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 50268-570_5773a885-471d-3e98-d897-dc2ba336410c 50268-570 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20160801 ANDA ANDA202566 AvPAK MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 50268-571_5773a885-471d-3e98-d897-dc2ba336410c 50268-571 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20160801 ANDA ANDA202566 AvPAK MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 50268-572_85417ef4-0b8b-5671-5c40-2e1541016866 50268-572 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20160914 ANDA ANDA065123 AvPAK MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 50268-573_bd71531f-ce41-f5fb-456a-559f4b67e43f 50268-573 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20141111 ANDA ANDA200405 AvPAK MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 50268-574_bd71531f-ce41-f5fb-456a-559f4b67e43f 50268-574 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20141112 ANDA ANDA200405 AvPAK MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 50268-575_bd71531f-ce41-f5fb-456a-559f4b67e43f 50268-575 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20141002 ANDA ANDA201522 AvPAK MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 50268-576_eecff0cd-8ee2-06bb-c46e-e1b76320d290 50268-576 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET, FILM COATED ORAL 20160722 ANDA ANDA202632 AvPAK MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50268-581_2a32a5ec-8381-b237-6c75-795247089599 50268-581 HUMAN PRESCRIPTION DRUG Mycophenolate mofetil Mycophenolate mofetil TABLET, FILM COATED ORAL 20160825 ANDA ANDA090456 AvPAK MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 50268-584_9eaead94-c8eb-4955-b570-4ad0ef3d0567 50268-584 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20170914 ANDA ANDA203578 AvPAK NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 50268-586_9eaead94-c8eb-4955-b570-4ad0ef3d0567 50268-586 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20170914 ANDA ANDA203578 AvPAK NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 50268-589_2986e6ad-750e-1b27-6479-a72f6466b5ef 50268-589 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20161122 ANDA ANDA091083 AvPAK NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50268-590_2986e6ad-750e-1b27-6479-a72f6466b5ef 50268-590 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20161122 ANDA ANDA091083 AvPAK NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50268-592_c6d19254-e24f-3d66-ea34-4db716532ae6 50268-592 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20121011 ANDA ANDA078432 AvPAK NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50268-593_c6d19254-e24f-3d66-ea34-4db716532ae6 50268-593 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20121011 ANDA ANDA078432 AvPAK NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50268-594_52f723e3-11dc-24b3-848e-60f265ad83a5 50268-594 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20150205 ANDA ANDA075927 AvPAK NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50268-595_52f723e3-11dc-24b3-848e-60f265ad83a5 50268-595 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20150205 ANDA ANDA075927 AvPAK NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50268-596_52f723e3-11dc-24b3-848e-60f265ad83a5 50268-596 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20150205 ANDA ANDA075927 AvPAK NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50268-597_cfe4585b-bf25-71d0-3c59-2d5e370f3b08 50268-597 HUMAN PRESCRIPTION DRUG Nifedipine ER Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 AvPAK NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50268-598_cfe4585b-bf25-71d0-3c59-2d5e370f3b08 50268-598 HUMAN PRESCRIPTION DRUG Nifedipine ER Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 AvPAK NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50268-599_cfe4585b-bf25-71d0-3c59-2d5e370f3b08 50268-599 HUMAN PRESCRIPTION DRUG Nifedipine ER Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071003 ANDA ANDA077410 AvPAK NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50268-600_ae47b610-544d-f251-cce6-f8ebc6aa8fe9 50268-600 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 20150729 ANDA ANDA072579 AvPAK NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50268-601_ae47b610-544d-f251-cce6-f8ebc6aa8fe9 50268-601 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 20150729 ANDA ANDA072556 AvPAK NIFEDIPINE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50268-602_7759504e-becc-af06-7d44-c2f91ce0991a 50268-602 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone TABLET ORAL 20141117 ANDA ANDA200275 AvPAK NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 50268-603_234de3aa-b83d-44df-ac54-1a6c08c693a6 50268-603 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20170314 ANDA ANDA075520 AvPAK NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50268-604_234de3aa-b83d-44df-ac54-1a6c08c693a6 50268-604 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20170314 ANDA ANDA075520 AvPAK NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50268-605_234de3aa-b83d-44df-ac54-1a6c08c693a6 50268-605 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20170314 ANDA ANDA075520 AvPAK NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50268-609_7e0012f4-57d2-9931-36de-b915e7f9b810 50268-609 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20161012 ANDA ANDA090798 AvPAK OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-610_7e0012f4-57d2-9931-36de-b915e7f9b810 50268-610 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20161012 ANDA ANDA090798 AvPAK OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-611_7e0012f4-57d2-9931-36de-b915e7f9b810 50268-611 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20161012 ANDA ANDA090798 AvPAK OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-612_7e0012f4-57d2-9931-36de-b915e7f9b810 50268-612 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20161012 ANDA ANDA090798 AvPAK OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-613_7e0012f4-57d2-9931-36de-b915e7f9b810 50268-613 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20161012 ANDA ANDA090798 AvPAK OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-614_7e0012f4-57d2-9931-36de-b915e7f9b810 50268-614 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20161012 ANDA ANDA090798 AvPAK OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-615_6c444ed9-3031-cbd3-bda4-96eca3ed1d86 50268-615 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140417 ANDA ANDA091415 AvPAK OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-616_6c444ed9-3031-cbd3-bda4-96eca3ed1d86 50268-616 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140417 ANDA ANDA091415 AvPAK OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-617_6c444ed9-3031-cbd3-bda4-96eca3ed1d86 50268-617 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140417 ANDA ANDA091415 AvPAK OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-618_6c444ed9-3031-cbd3-bda4-96eca3ed1d86 50268-618 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140417 ANDA ANDA091415 AvPAK OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-619_9c99c849-616b-4800-ff64-d503fdd0c11e 50268-619 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20110711 ANDA ANDA075410 AvPAK OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50268-620_9c99c849-616b-4800-ff64-d503fdd0c11e 50268-620 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20110711 ANDA ANDA075410 AvPAK OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50268-621_d5f1c26b-c45e-bad9-edf1-b9dbb2eb80e2 50268-621 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20160805 ANDA ANDA078539 AvPAK ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 50268-622_d5f1c26b-c45e-bad9-edf1-b9dbb2eb80e2 50268-622 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20160805 ANDA ANDA078539 AvPAK ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 50268-623_20ffda8d-3f42-442a-bfa8-9d99b497539e 50268-623 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20171208 ANDA ANDA073671 AvPAK NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 50268-624_20ffda8d-3f42-442a-bfa8-9d99b497539e 50268-624 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20171208 ANDA ANDA073652 AvPAK NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 50268-627_0fd19753-cfd1-15fd-9459-420909b0eab1 50268-627 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20120517 ANDA ANDA078503 AvPAK OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 50268-628_0fd19753-cfd1-15fd-9459-420909b0eab1 50268-628 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20120517 ANDA ANDA078503 AvPAK OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 50268-629_0fd19753-cfd1-15fd-9459-420909b0eab1 50268-629 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20120516 ANDA ANDA078503 AvPAK OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 50268-630_8119abe7-18c1-f3e4-fe4c-10c7c4462ee1 50268-630 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20160524 ANDA ANDA201504 AvPAK QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-631_8119abe7-18c1-f3e4-fe4c-10c7c4462ee1 50268-631 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20160524 ANDA ANDA201504 AvPAK QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-632_8119abe7-18c1-f3e4-fe4c-10c7c4462ee1 50268-632 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20160524 ANDA ANDA201504 AvPAK QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-633_8119abe7-18c1-f3e4-fe4c-10c7c4462ee1 50268-633 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20160524 ANDA ANDA201504 AvPAK QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-634_8119abe7-18c1-f3e4-fe4c-10c7c4462ee1 50268-634 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20160524 ANDA ANDA201504 AvPAK QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-635_8119abe7-18c1-f3e4-fe4c-10c7c4462ee1 50268-635 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20160524 ANDA ANDA201504 AvPAK QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-636_2c9bf1b5-18ef-7dec-a071-6d540ec3ad14 50268-636 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130115 ANDA ANDA078281 AvPAK PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 50268-639_2c9bf1b5-18ef-7dec-a071-6d540ec3ad14 50268-639 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20150130 ANDA ANDA078281 AvPAK PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 50268-640_2b07b378-ade5-dbcd-0b99-dd770c478baf 50268-640 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20160311 ANDA ANDA078406 AvPAK PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-641_2b07b378-ade5-dbcd-0b99-dd770c478baf 50268-641 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20160311 ANDA ANDA078406 AvPAK PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-642_2b07b378-ade5-dbcd-0b99-dd770c478baf 50268-642 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20160311 ANDA ANDA078406 AvPAK PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-643_2b07b378-ade5-dbcd-0b99-dd770c478baf 50268-643 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20160311 ANDA ANDA078406 AvPAK PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-653_2dc79652-0b53-4d56-a41d-a86c702de763 50268-653 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20170724 UNAPPROVED DRUG OTHER AvPAK PHENOBARBITAL 15 mg/1 CIV N 20181231 50268-654_2dc79652-0b53-4d56-a41d-a86c702de763 50268-654 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20170724 UNAPPROVED DRUG OTHER AvPAK PHENOBARBITAL 30 mg/1 CIV N 20181231 50268-655_2dc79652-0b53-4d56-a41d-a86c702de763 50268-655 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20170724 UNAPPROVED DRUG OTHER AvPAK PHENOBARBITAL 60 mg/1 CIV N 20181231 50268-671_5703348d-4c60-b210-144c-cea3f9b5629c 50268-671 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20160128 ANDA ANDA202128 AvPAK POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 50268-672_94302c20-d386-769b-e69d-c07b87540bce 50268-672 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20160315 ANDA ANDA076397 AvPAK PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-673_94302c20-d386-769b-e69d-c07b87540bce 50268-673 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20160315 ANDA ANDA076397 AvPAK PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-686_0a24a7ea-10a9-b084-baff-54255eac4ad6 50268-686 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20110519 ANDA ANDA040866 AvPAK PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-687_0a24a7ea-10a9-b084-baff-54255eac4ad6 50268-687 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20110519 ANDA ANDA040866 AvPAK PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50268-692_81377a2f-c4a8-b984-1be9-41c524040a5a 50268-692 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20150804 ANDA ANDA077824 AvPAK RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50268-693_81377a2f-c4a8-b984-1be9-41c524040a5a 50268-693 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20150804 ANDA ANDA077824 AvPAK RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50268-695_21297bd2-00b8-21de-de4d-0dbabd18511f 50268-695 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140827 ANDA ANDA078040 AvPAK RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-696_21297bd2-00b8-21de-de4d-0dbabd18511f 50268-696 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140827 ANDA ANDA078040 AvPAK RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-697_21297bd2-00b8-21de-de4d-0dbabd18511f 50268-697 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140827 ANDA ANDA078040 AvPAK RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-698_21297bd2-00b8-21de-de4d-0dbabd18511f 50268-698 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140827 ANDA ANDA078040 AvPAK RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-699_21297bd2-00b8-21de-de4d-0dbabd18511f 50268-699 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140827 ANDA ANDA078040 AvPAK RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 50268-700_62d3353e-08a4-b429-e053-2a91aa0ab237 50268-700 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20180115 ANDA ANDA070175 AvPAK PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 50268-701_62d3353e-08a4-b429-e053-2a91aa0ab237 50268-701 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20180115 ANDA ANDA070176 AvPAK PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 50268-702_62d3353e-08a4-b429-e053-2a91aa0ab237 50268-702 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20180115 ANDA ANDA070177 AvPAK PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 50268-712_d211da8e-f9e8-c418-6e50-fed6b9136f86 50268-712 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141202 ANDA ANDA077691 AvPAK SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-713_d211da8e-f9e8-c418-6e50-fed6b9136f86 50268-713 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141202 ANDA ANDA077691 AvPAK SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-714_d211da8e-f9e8-c418-6e50-fed6b9136f86 50268-714 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141202 ANDA ANDA077691 AvPAK SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-715_d211da8e-f9e8-c418-6e50-fed6b9136f86 50268-715 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141202 ANDA ANDA077691 AvPAK SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-716_d211da8e-f9e8-c418-6e50-fed6b9136f86 50268-716 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141202 ANDA ANDA077691 AvPAK SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50268-717_983342a7-2c95-2dd6-d24a-78c1f58d09f8 50268-717 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET ORAL 20150529 ANDA ANDA202025 AvPAK SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 50268-726_a26bb6b1-f0d3-4d30-220e-d1c6ee14e7c7 50268-726 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20110519 ANDA ANDA040353 AvPAK SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 50268-728_8faea049-4465-ca88-e1d2-7b81d152c2cd 50268-728 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140923 ANDA ANDA090624 AvPAK SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 50268-729_8faea049-4465-ca88-e1d2-7b81d152c2cd 50268-729 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140923 ANDA ANDA090624 AvPAK SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 50268-730_11e7b169-220e-6b25-8769-11d8fd31cb44 50268-730 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20140114 ANDA ANDA085828 AvPAK SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 50268-740_62fa7fdf-c589-6f79-e053-2a91aa0a4c19 50268-740 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20180117 ANDA ANDA207405 AvPAK TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 50268-750_646c2247-840a-8b09-e4a3-2de6a9e34a47 50268-750 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140917 ANDA ANDA079162 AvPAK TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50268-751_646c2247-840a-8b09-e4a3-2de6a9e34a47 50268-751 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140917 ANDA ANDA079162 AvPAK TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50268-752_646c2247-840a-8b09-e4a3-2de6a9e34a47 50268-752 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140917 ANDA ANDA079162 AvPAK TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50268-753_646c2247-840a-8b09-e4a3-2de6a9e34a47 50268-753 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140917 ANDA ANDA079162 AvPAK TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50268-754_1ffb99da-a666-3823-0d58-dd29fb80cf76 50268-754 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20141007 ANDA ANDA079234 AvPAK TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50268-755_1ffb99da-a666-3823-0d58-dd29fb80cf76 50268-755 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20141007 ANDA ANDA079234 AvPAK TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50268-756_1ffb99da-a666-3823-0d58-dd29fb80cf76 50268-756 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20141007 ANDA ANDA079234 AvPAK TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50268-757_1ffb99da-a666-3823-0d58-dd29fb80cf76 50268-757 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20141007 ANDA ANDA079234 AvPAK TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50268-759_021f84b8-4c61-42be-b0d9-422737303bf9 50268-759 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20170824 ANDA ANDA076286 AvPAK TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50268-760_021f84b8-4c61-42be-b0d9-422737303bf9 50268-760 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20170824 ANDA ANDA076286 AvPAK TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50268-761_bd85642f-0762-4fe4-8cd6-9a3c95379f71 50268-761 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170323 ANDA ANDA203691 AvPAK TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 50268-762_bd85642f-0762-4fe4-8cd6-9a3c95379f71 50268-762 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170323 ANDA ANDA203691 AvPAK TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 50268-763_bd85642f-0762-4fe4-8cd6-9a3c95379f71 50268-763 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170323 ANDA ANDA203691 AvPAK TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 50268-771_ed36f40c-b6c9-de2a-e957-752cc7c157e1 50268-771 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20160808 ANDA ANDA071196 AvPAK TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 50268-774_dc8b112e-804c-b6b3-4ecd-1231d97346fd 50268-774 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20150114 ANDA ANDA090485 AvPAK TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50268-775_60fe1c72-6583-8bf3-c896-c983485a78ca 50268-775 HUMAN PRESCRIPTION DRUG Trimethoprim Trimethoprim TABLET ORAL 20130731 ANDA ANDA070049 AvPAK TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 50268-783_501da7f0-9d3d-6836-8b3f-2c21edee0519 50268-783 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160629 ANDA ANDA203311 AvPAK VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-784_501da7f0-9d3d-6836-8b3f-2c21edee0519 50268-784 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160629 ANDA ANDA203311 AvPAK VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-785_501da7f0-9d3d-6836-8b3f-2c21edee0519 50268-785 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160629 ANDA ANDA203311 AvPAK VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-786_501da7f0-9d3d-6836-8b3f-2c21edee0519 50268-786 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160629 ANDA ANDA203311 AvPAK VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-787_174dd06d-3026-2e23-7f76-1f827f96fdde 50268-787 HUMAN PRESCRIPTION DRUG Valganciclovir Valganciclovir TABLET, FILM COATED ORAL 20160727 ANDA ANDA205166 AvPAK VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 50268-788_b9415153-0008-74c7-353d-958c42faea22 50268-788 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20140922 ANDA ANDA090682 AvPAK VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50268-789_b9415153-0008-74c7-353d-958c42faea22 50268-789 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20140922 ANDA ANDA090682 AvPAK VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50268-790_6270d966-da4f-3b24-8c2a-60f332d1b9bd 50268-790 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160801 ANDA ANDA078946 AvPAK HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-791_6270d966-da4f-3b24-8c2a-60f332d1b9bd 50268-791 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160801 ANDA ANDA078946 AvPAK HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-792_6270d966-da4f-3b24-8c2a-60f332d1b9bd 50268-792 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160801 ANDA ANDA078946 AvPAK HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-793_6270d966-da4f-3b24-8c2a-60f332d1b9bd 50268-793 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160801 ANDA ANDA078946 AvPAK HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-794_6270d966-da4f-3b24-8c2a-60f332d1b9bd 50268-794 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160801 ANDA ANDA078946 AvPAK HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50268-796_e860e5ae-3f1f-0ec6-61ea-0d522a3297c3 50268-796 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20120725 ANDA ANDA075517 AvPAK URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 50268-798_6a33a904-0dc1-b683-bd9b-35615726f8ff 50268-798 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20160531 ANDA ANDA079098 AvPAK VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-799_6a33a904-0dc1-b683-bd9b-35615726f8ff 50268-799 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20160531 ANDA ANDA079098 AvPAK VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-800_6a33a904-0dc1-b683-bd9b-35615726f8ff 50268-800 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20160531 ANDA ANDA079098 AvPAK VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-801_6a33a904-0dc1-b683-bd9b-35615726f8ff 50268-801 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20160531 ANDA ANDA079098 AvPAK VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-802_6a33a904-0dc1-b683-bd9b-35615726f8ff 50268-802 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20160531 ANDA ANDA079098 AvPAK VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50268-804_4944dae2-66b4-4f51-8211-c2cb84dfb0bb 50268-804 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET ORAL 20161207 ANDA ANDA206747 AvPAK VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 50268-805_c063565a-bf48-4941-9db5-aff7b39412c7 50268-805 HUMAN PRESCRIPTION DRUG Zafirlukast Zafirlukast TABLET, FILM COATED ORAL 20170915 ANDA ANDA090372 AvPAK ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 50268-816_67faf46c-2eef-4843-8622-78eb5c6eafeb 50268-816 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20140702 ANDA ANDA077869 AvPAK ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50269-220_60a45d64-aca4-f579-e053-2991aa0aacb4 50269-220 HUMAN OTC DRUG Zantac 150 RANITIDINE TABLET ORAL 20160729 NDA NDA021698 JC World Bell Wholesale Co., Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 50269-222_60a48e93-d396-36ed-e053-2a91aa0a975b 50269-222 HUMAN OTC DRUG Zantac 75 RANITIDINE TABLET ORAL 20160729 NDA NDA020520 JC World Bell Wholesale Co., Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 50269-476_356a907d-8aad-1121-e054-00144ff8d46c 50269-476 HUMAN OTC DRUG Pepto Bismol BISMUTH SUBSALICYLATE TABLET ORAL 20160616 OTC MONOGRAPH FINAL part335 JC World Bell Wholesale Co., Inc. BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 50269-557_5a54bae0-16fd-7137-e053-2991aa0a1b5e 50269-557 HUMAN OTC DRUG Vicks NyQuil Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20150601 20181101 OTC MONOGRAPH FINAL part341 JC World Bell Wholesale Co., Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 50269-691_bc702d65-d81a-4ba1-947a-4b82226c6d7c 50269-691 HUMAN OTC DRUG Pepto-Bismol Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20150601 OTC MONOGRAPH FINAL part335 JC World Bell Wholesale Co., Inc. BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 50269-811_bbe23871-56af-411a-9c22-97eefac8ef63 50269-811 HUMAN OTC DRUG Vicks DayQuil Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20150601 OTC MONOGRAPH FINAL part341 JC World Bell Wholesale Co., Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 50269-813_33d7d1b8-b372-17d2-e054-00144ff8d46c 50269-813 HUMAN OTC DRUG NyQuil Severe Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20160526 OTC MONOGRAPH FINAL part341 JC World Bell Wholesale Co., Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 50289-3250_bc28ef5d-20c3-44cb-8c98-95be042379eb 50289-3250 HUMAN OTC DRUG AER Pre-moistened Witch Hazel Pad Witch Hazel SOLUTION RECTAL; TOPICAL 20111230 OTC MONOGRAPH FINAL part346 Birchwood Laboratories Inc WITCH HAZEL .5 mL/mL N 20181231 50289-9250_d8238a39-7224-4782-946c-a17e5154a571 50289-9250 HUMAN OTC DRUG B-SURE Traveler Towelette B-SURE Traveler SOLUTION RECTAL; TOPICAL 20080701 OTC MONOGRAPH FINAL part346 Birchwood Laboratories Inc WITCH HAZEL .5 g/g N 20181231 50297-0001_ef71b5ba-5eb0-4ffc-9613-20da97a66395 50297-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090730 UNAPPROVED MEDICAL GAS Pure Oxygen Services OXYGEN 99 L/100L E 20171231 50300-010_a9135b18-5e61-495f-a1f6-f5e6149b5a0a 50300-010 HUMAN OTC DRUG GOONG MAHN GEUM BENZALKONIUM CHLORIDE PILL VAGINAL 20120301 OTC MONOGRAPH NOT FINAL part333A CHUNG SOL BENZALKONIUM CHLORIDE .003 g/1 E 20171231 50302-100_00c18c7f-e8de-4fc5-a1e3-6b8b7588b9c9 50302-100 HUMAN OTC DRUG Panrosa Antibacterial Hand With Moisturizers TRICLOSAN SOAP TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. TRICLOSAN 1.5 mg/mL E 20171231 50302-200_6064142c-2129-68ce-e053-2991aa0a1192 50302-200 HUMAN OTC DRUG Panrosa Instant Antiseptic Hand Sanitizer With Moisturizers ALCOHOL GEL TOPICAL 20100203 20200203 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. ALCOHOL 62 mL/100mL N 20181231 50302-300_24e51fec-57f8-4582-ad0b-e3233c774a61 50302-300 HUMAN OTC DRUG PANROSA Green Apple Scented Hand TRICLOSAN SOAP TOPICAL 20101210 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. TRICLOSAN .115 mL/100mL E 20171231 50302-320_4a66f9c1-28a9-23a5-e054-00144ff88e88 50302-320 HUMAN OTC DRUG PANROSA Lavender Scented Hand TRICLOSAN SOAP TOPICAL 20101210 20200203 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. TRICLOSAN 1.15 mg/mL N 20191231 50302-330_55e1c338-42ea-45cc-8264-507d7f117343 50302-330 HUMAN OTC DRUG PANROSA Rose Scented Hand TRICLOSAN SOAP TOPICAL 20101210 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. TRICLOSAN .115 mL/100mL E 20171231 50302-340_4a679629-b7db-3e73-e054-00144ff88e88 50302-340 HUMAN OTC DRUG PANROSA Antibacterial Hand TRICLOSAN SOAP TOPICAL 20101210 20200203 OTC MONOGRAPH NOT FINAL part333A Panrosa Enterprises, Inc. TRICLOSAN 1.5 mg/mL N 20191231 50302-400_6063c4fb-c121-9e7e-e053-2a91aa0a482d 50302-400 HUMAN OTC DRUG Panrosa FRESH CLEAN Pyrithione Zinc Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20130301 OTC MONOGRAPH FINAL part358H Panrosa Enterprises, Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 50302-500_6191aa37-914b-207c-e053-2a91aa0af2d0 50302-500 HUMAN OTC DRUG Antibacterial Hand Green Apple Scented CHLOROXYLENOL LIQUID TOPICAL 20160520 OTC MONOGRAPH NOT FINAL part333E PANROSA ENTERPRISES, INC. CHLOROXYLENOL 2.5 mg/mL N 20181231 50302-510_57fa6eb8-36bf-4138-e053-2991aa0a58cd 50302-510 HUMAN OTC DRUG Antibacterial Hand Milk and Honey Scented CHLOROXYLENOL LIQUID TOPICAL 20160520 OTC MONOGRAPH NOT FINAL part333E PANROSA ENTERPRISES, INC. CHLOROXYLENOL 2.5 mg/mL N 20181231 50302-520_57fa6eb8-36b2-4138-e053-2991aa0a58cd 50302-520 HUMAN OTC DRUG Antibacterial Hand Shea Butter Scented CHLOROXYLENOL LIQUID TOPICAL 20160520 OTC MONOGRAPH NOT FINAL part333E PANROSA ENTERPRISES, INC. CHLOROXYLENOL 2.5 mg/mL N 20181231 50302-530_57fa5fc8-5d3e-f81d-e053-2991aa0ac47f 50302-530 HUMAN OTC DRUG Antibacterial Hand Rose Scented CHLOROXYLENOL LIQUID TOPICAL 20160520 OTC MONOGRAPH NOT FINAL part333E PANROSA ENTERPRISES, INC. CHLOROXYLENOL 2.5 mg/mL N 20181231 50302-540_57fa94ed-b28d-456a-e053-2a91aa0af484 50302-540 HUMAN OTC DRUG Hand Antibacterial CHLOROXYLENOL SOAP TOPICAL 20160520 OTC MONOGRAPH NOT FINAL part333E PANROSA ENTERPRISES, INC. CHLOROXYLENOL 2.5 mg/mL N 20181231 50305-120_6f4aa252-aee6-485e-ab23-10e074e87d8c 50305-120 HUMAN OTC DRUG Labsco Sterile Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20120503 OTC MONOGRAPH FINAL part344 Laboratory Supply Company ISOPROPYL ALCOHOL .7 mL/mL N 20181231 50306-000_32e45245-0705-4ef7-9c07-f3c3b29f27a4 50306-000 HUMAN OTC DRUG Le Vital Wake Me Up ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Shanghai Lantern Cosmetic Co., Ltd. ALCOHOL 62 g/100g E 20171231 50306-001_4b2e8d2f-177c-4425-90ae-6273d806e33a 50306-001 HUMAN OTC DRUG Le Vital Hidden Passion ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Shanghai Lantern Cosmetic Co., Ltd. ALCOHOL 62 g/100g E 20171231 50306-002_b0fb692e-665c-4ec0-95ad-4351aad7fddf 50306-002 HUMAN OTC DRUG Le Vital Dreamy Glow ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Shanghai Lantern Cosmetic Co., Ltd. ALCOHOL 62 g/100g E 20171231 50306-003_bc8791f2-6dba-4bf1-bb1e-f61a2de15b01 50306-003 HUMAN OTC DRUG Le Vital Blossom Delight ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Shanghai Lantern Cosmetic Co., Ltd. ALCOHOL 62 g/100g E 20171231 50306-004_5ccbd3ac-e36a-4aba-9f25-9f7f66c9d70c 50306-004 HUMAN OTC DRUG Le Vital Berry Kissed ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Shanghai Lantern Cosmetic Co., Ltd. ALCOHOL 62 g/100g E 20171231 50306-005_01d375e5-b10f-4292-8154-98531703ec8f 50306-005 HUMAN OTC DRUG Le Vital Japanese Cherry Blossom ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Shanghai Lantern Cosmetic Co., Ltd. ALCOHOL 62 g/100g E 20171231 50306-006_218380c1-97f1-4c64-bfcf-908a5cb9ce90 50306-006 HUMAN OTC DRUG Le Vital Midnight Rush ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Shanghai Lantern Cosmetic Co., Ltd. ALCOHOL 62 g/100g E 20171231 50306-007_1ac9eadd-6a7b-4728-9661-a67e54b03257 50306-007 HUMAN OTC DRUG Le Vital Moon to Light ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Shanghai Lantern Cosmetic Co., Ltd. ALCOHOL 62 g/100g E 20171231 50306-008_d2d3f4fd-84a1-46cd-bab5-c8cec5c14753 50306-008 HUMAN OTC DRUG Le Vital Sweet Pea ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Shanghai Lantern Cosmetic Co., Ltd. ALCOHOL 62 g/100g E 20171231 50306-009_aa1edeb7-1d5c-4a93-81eb-c1abd6972b43 50306-009 HUMAN OTC DRUG Le Vital Vanilla Heaven ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Shanghai Lantern Cosmetic Co., Ltd. ALCOHOL 62 g/100g E 20171231 50306-010_32f88ea4-4cf8-05c7-e054-00144ff88e88 50306-010 HUMAN OTC DRUG Daily Moisturizing with Colloidal Oats CETYL ALCOHOL 0.80% LOTION TOPICAL 20160516 UNAPPROVED DRUG OTHER Shanghai Lantern Cosmetic Co CETYL ALCOHOL 80 mg/100mL E 20171231 50306-011_32f89d79-20f2-4b3b-e054-00144ff8d46c 50306-011 HUMAN OTC DRUG All Day Skin Relief with Colloidal Oats CETYL ALCOHOL LOTION TOPICAL 20160516 UNAPPROVED DRUG OTHER Shanghai Lantern Cosmetic Co CETYL ALCOHOL 80 mg/100mL E 20171231 50308-001_8bf9e434-f0d6-46c5-8630-8b2720032d30 50308-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19500101 UNAPPROVED MEDICAL GAS Ohio Air Products of Canton, Inc. OXYGEN 990 mL/L E 20171231 50309-777_8d0e5e63-2766-4a91-98a7-a4e203a1a6f5 50309-777 HUMAN OTC DRUG Pain Relieving Patch MENTHOL PATCH TOPICAL 20100130 OTC MONOGRAPH NOT FINAL part348 Heilongjiang Huashen Science & Technology Development Co Ltd MENTHOL .2 1/1 E 20171231 50320-111_9514da65-6c4b-4d24-a764-fdfac847680d 50320-111 HUMAN OTC DRUG Monk Hand Sanitizing Wipes Benzethonium Chloride CLOTH TOPICAL 20100106 OTC MONOGRAPH NOT FINAL part333 National Towelette Company BENZETHONIUM CHLORIDE 30 mL/1000mL E 20171231 50322-003_ed9a66b4-8b1d-4eaf-886b-94e9cfa256b1 50322-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20090101 NDA NDA205866 C & C Oxygen Company NITROGEN 990 mL/L N 20181231 50322-005_c6d7e28e-d69c-4c0e-b112-8716104a3b50 50322-005 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091210 NDA NDA205865 C & C Oxygen Company OXYGEN 990 mL/L N 20181231 50332-0029_ef848a1c-6ea9-44d9-a5da-e0554a133ee0 50332-0029 HUMAN OTC DRUG Blistex Lip dimethicone, camphor, menthol, phenol OINTMENT TOPICAL 19950809 OTC MONOGRAPH NOT FINAL part348 HART Health DIMETHICONE; CAMPHOR OIL; MENTHOL; PHENOL 1.1; .5; .6; .5 g/100g; g/100g; g/100g; g/100g E 20171231 50332-0031_a9857098-f25d-46e2-91d9-82c3fecf8c28 50332-0031 HUMAN OTC DRUG TRIBIOTICLC LC LC BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE OINTMENT TOPICAL 20120504 OTC MONOGRAPH FINAL part333B HART Health BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; LIDOCAINE 400; 5; 5000; 40 1/g; mg/g; 1/g; mg/g N 20181231 50332-0032_42ef4a98-b629-4cbb-ad6d-2bf06cb0d7c3 50332-0032 HUMAN OTC DRUG TRIBIOTIC BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE OINTMENT TOPICAL 20051003 OTC MONOGRAPH FINAL part333B HART Health BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 1/g; mg/g; 1/g N 20181231 50332-0042_72700593-9738-4fb2-9846-70774c3e1846 50332-0042 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE ACETATE CREAM TOPICAL 19900130 OTC MONOGRAPH NOT FINAL part348 HART Health HYDROCORTISONE ACETATE 10 mg/g N 20181231 50332-0043_44beada9-cee7-4e34-9cd2-59f17f962b05 50332-0043 HUMAN OTC DRUG WOUND WIPES benzalkonium chloride SWAB TOPICAL 19740101 OTC MONOGRAPH NOT FINAL part333A HART Health BENZALKONIUM CHLORIDE .0013 g/g N 20181231 50332-0046_7915b6ad-78b8-4ae2-818e-13e3cbb82525 50332-0046 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 19740401 OTC MONOGRAPH FINAL part344 HART Health ISOPROPYL ALCOHOL .7 g/g N 20181231 50332-0047_ea4d8769-9526-46e9-9288-d910ce26791f 50332-0047 HUMAN OTC DRUG PVP Iodine Povidone-Iodine SWAB TOPICAL 19740401 OTC MONOGRAPH NOT FINAL part333A HART Health POVIDONE-IODINE .1 g/g N 20181231 50332-0048_4b548097-d596-4cf5-acd1-b58bc14abe43 50332-0048 HUMAN OTC DRUG Sooth-a-Sting BENZOCAINE, ISOPROPYL ALCOHOL SWAB TOPICAL 19740401 OTC MONOGRAPH NOT FINAL part348 HART Health BENZOCAINE; ISOPROPYL ALCOHOL .06; .6 g/g; 1/g N 20181231 50332-0102_bc2b8b1e-0402-4d4c-ad0f-edeafeb8f44c 50332-0102 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET ORAL 19860604 OTC MONOGRAPH FINAL part343 HART Health ASPIRIN 325 mg/1 N 20181231 50332-0103_c8feb7bc-c862-489b-9d88-6cca7bc3588a 50332-0103 HUMAN OTC DRUG CETAFEN ACETAMINOPHEN TABLET ORAL 19860604 OTC MONOGRAPH NOT FINAL part343 HART Health ACETAMINOPHEN 325 mg/1 N 20181231 50332-0105_16b4d71a-fead-491a-b5dc-a170f5c96dd8 50332-0105 HUMAN OTC DRUG EXAPRIN acetaminophen, aspirin, caffeine, salicylamide TABLET ORAL 19870120 OTC MONOGRAPH NOT FINAL part343 HART Health ACETAMINOPHEN; ASPIRIN; CAFFEINE; SALICYLAMIDE 110; 162; 32.4; 152 mg/1; mg/1; mg/1; mg/1 N 20181231 50332-0106_3e776f16-02e7-49e5-9ff3-40fc35e90afe 50332-0106 HUMAN OTC DRUG NUTRALOX CALCIUM CARBONATE TABLET, CHEWABLE ORAL 19870120 OTC MONOGRAPH FINAL part331 HART Health CALCIUM CARBONATE 420 mg/1 N 20181231 50332-0108_be810cb9-d7f4-481a-808f-527c3a157b29 50332-0108 HUMAN OTC DRUG CETAFEN EXTRA acetaminophen TABLET ORAL 19900105 OTC MONOGRAPH NOT FINAL part343 HART Health ACETAMINOPHEN 500 mg/1 N 20181231 50332-0109_bf79ff33-0c19-4066-afe4-a14a118bb067 50332-0109 HUMAN OTC DRUG Proprinal ibuprofen TABLET, SUGAR COATED ORAL 19900601 OTC MONOGRAPH NOT FINAL part343 NorMed IBUPROFEN 200 mg/1 N 20181231 50332-0118_c390ecb3-4a05-452e-9a46-7852100ccffb 50332-0118 HUMAN OTC DRUG IBUPROFEN ibuprofen TABLET ORAL 19870603 OTC MONOGRAPH NOT FINAL part343 HART Health IBUPROFEN 200 mg/1 E 20171231 50332-0126_aff1a2e6-dfd0-48b3-ad03-f557602c58fd 50332-0126 HUMAN OTC DRUG Sudo-Tab PE phenylephrine hcl TABLET ORAL 20051003 OTC MONOGRAPH FINAL part341 HART Health PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 E 20171231 50332-0127_cdc37028-7070-4541-8d4a-52507e512a6b 50332-0127 HUMAN OTC DRUG Relief-PE ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE TABLET, COATED ORAL 20120416 OTC MONOGRAPH NOT FINAL part343 NorMed ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE 325; 5; 2 mg/1; mg/1; mg/1 E 20171231 50332-0132_799687e5-495e-4976-9c42-646e23168002 50332-0132 HUMAN OTC DRUG HISTAPRIN DIPHENHYDRAMINE TABLET ORAL 20090101 OTC MONOGRAPH FINAL part336 NorMed DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50332-0201_10cfade6-b054-47a5-8044-78b9da174b1c 50332-0201 HUMAN OTC DRUG Eye Clean Eye Wash LIQUID OPHTHALMIC 19000101 OTC MONOGRAPH FINAL part349 HART Health WATER 98.3 mL/100mL E 20171231 50332-0212_2dd9c749-a510-4b9e-acdf-0f34c5239ee9 50332-0212 HUMAN OTC DRUG First Aid Benzalkonium Chloride, Benzocaine SPRAY TOPICAL 19960206 OTC MONOGRAPH FINAL part333A HART Health BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/1000mg; mg/1000mg N 20181231 50346-001_f0a92676-2545-457f-80c3-d2e24b83653d 50346-001 HUMAN OTC DRUG Pure Petroleum White Petroleum JELLY TOPICAL 20120526 OTC MONOGRAPH FINAL part347 Pan Aromas LLC PETROLATUM 1 g/g N 20181231 50346-002_2160c60b-093e-4042-9b7a-6568b5527b36 50346-002 HUMAN OTC DRUG Baby Fresh Scent Petroleum White Petroleum JELLY TOPICAL 20120526 OTC MONOGRAPH FINAL part347 Pan Aromas LLC PETROLATUM .99 g/g N 20181231 50346-003_b1e5495f-9bdf-4264-9cd1-3d004d2f599f 50346-003 HUMAN OTC DRUG Pure Petroleum Cocoa Butter Scented White Petroleum JELLY TOPICAL 20120526 OTC MONOGRAPH FINAL part347 Pan Aromas LLC PETROLATUM .99 g/g N 20181231 50346-004_e8f3c7ef-caed-42fc-bdc6-532544390ee8 50346-004 HUMAN OTC DRUG Pan Aromas Baby TALC POWDER TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part347 Pan Aromas LLC TALC 1 g/g N 20181231 50346-005_a1ef7014-45b2-408e-8e99-952c0ffbcc27 50346-005 HUMAN OTC DRUG Pan Aromas Baby Mineral Oil OIL TOPICAL 20121220 OTC MONOGRAPH FINAL part347 Pan Aromas LLC MINERAL OIL 99.9 mL/100mL N 20181231 50353-100_44f1506a-45ff-44e9-a016-014f5ecb740b 50353-100 HUMAN OTC DRUG Purmist CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL SOLUTION TOPICAL 20100601 OTC MONOGRAPH FINAL part333 MKR International Inc ALCOHOL; CHLORHEXIDINE GLUCONATE .7; .01 g/mL; g/mL E 20171231 50353-101_23cadcaa-85ff-4e72-a3e2-88fde5ad51f1 50353-101 HUMAN OTC DRUG Purmist CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL SOLUTION TOPICAL 20100601 OTC MONOGRAPH FINAL part333 MKR International Inc ALCOHOL; CHLORHEXIDINE GLUCONATE .7; .01 g/mL; g/mL E 20171231 50353-102_a7019078-4f92-487b-8104-2e7347befa97 50353-102 HUMAN OTC DRUG Purmist CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL SOLUTION TOPICAL 20100601 OTC MONOGRAPH FINAL part333 MKR International Inc ALCOHOL; CHLORHEXIDINE GLUCONATE .7; .01 g/mL; g/mL E 20171231 50353-103_e0ff1b42-3823-43b0-a3e1-2c21b3fbf932 50353-103 HUMAN OTC DRUG Purmist CHLORHEXIDINE GLUCONATE, ETHYL ALCOHOL SOLUTION TOPICAL 20100601 OTC MONOGRAPH FINAL part333 MKR International Inc ALCOHOL; CHLORHEXIDINE GLUCONATE .7; .01 g/mL; g/mL E 20171231 50353-150_61cf56c1-04e0-d288-e053-2a91aa0aa560 50353-150 HUMAN OTC DRUG PurMist benzalkonium chloride SPRAY TOPICAL 20171230 OTC MONOGRAPH NOT FINAL part333E MKR International Inc BENZALKONIUM CHLORIDE 13 mg/mL N 20191231 50367-100_d338e7ef-67ed-461f-ac55-9d9610c275e7 50367-100 HUMAN OTC DRUG FLUEndz Asafoetida, Astragalus Menziesii, Illicium Anisatum, Lonicera Zylosteum SPRAY ORAL 20100115 UNAPPROVED HOMEOPATHIC Herbology International LLC ASAFETIDA; ASTRAGALUS NUTTALLII LEAF; STAR ANISE; LONICERA XYLOSTEUM FRUIT 3; 6; 1; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 50375-2001_7490359b-f33e-4f4f-b0e5-1e2dc01fd312 50375-2001 HUMAN OTC DRUG Scal-tonic intensive liquid hair care panthenol LIQUID TOPICAL 20100301 UNAPPROVED DRUG OTHER Doori Cosmetics Co., Ltd PANTHENOL; MENTHOL; SALICYLIC ACID 200; 300; 250 mg/g; mg/g; mg/g E 20171231 50375-3001_17f6b292-aac0-4f27-b42e-e300bfe801ee 50375-3001 HUMAN OTC DRUG Scal tonic shampoo hair care panthenol SHAMPOO TOPICAL 20100301 UNAPPROVED DRUG OTHER Doori Cosmetics Co., Ltd PANTHENOL .002 mL/mL E 20171231 50375-4001_57ad69ad-d47e-43d2-acde-26462dc6f186 50375-4001 HUMAN OTC DRUG Intensive scalp care essence hair care panthenol LIQUID TOPICAL 20100301 UNAPPROVED DRUG OTHER Doori Cosmetics Co., Ltd PANTHENOL .002 mL/mL E 20171231 50375-5001_aa3ecbe1-ed79-4719-b40a-ed5dda9ee476 50375-5001 HUMAN OTC DRUG Intensive Scal Care Shampoo hair care panthenol SHAMPOO TOPICAL 20100301 UNAPPROVED DRUG OTHER Doori Cosmetics Co., Ltd PANTHENOL .02 mL/mL E 20171231 50382-002_43a17fc1-50a5-4be9-85d2-b0d7ed36be2b 50382-002 HUMAN OTC DRUG Saline Enema SALINE ENEMA ENEMA RECTAL 20130801 OTC MONOGRAPH NOT FINAL part334 Galentic Pharma (India) Priva Te Ltd. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 50382-003_ac08d733-4b4a-4721-b701-5c8444aafc8d 50382-003 HUMAN OTC DRUG Galentic Vitamin A D Petrolatum OINTMENT TOPICAL 20130806 OTC MONOGRAPH FINAL part347 Galentic Pharma (India) Priva Te Limited PETROLATUM .76 g/g E 20171231 50382-004_64c54ba8-05dd-48a2-b8c3-c26d7f869233 50382-004 HUMAN OTC DRUG Antifungal Antifungal CREAM TOPICAL 20130807 OTC MONOGRAPH FINAL part333C Galentic Pharma (India) Priva Te Limited CLOTRIMAZOLE 1 g/100g E 20171231 50382-005_2a35f493-11e4-49ab-bacd-3b1eede3d97a 50382-005 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20130802 OTC MONOGRAPH FINAL part333B Galentic Pharma (India) Priva Te Limited BACITRACIN 500 [iU]/g E 20171231 50382-006_37af0e27-24ed-45d3-a331-f3f9d263bb77 50382-006 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20170807 OTC MONOGRAPH FINAL part333B Galentic Pharma (India) Private Limited BACITRACIN ZINC 500 [iU]/g N 20181231 50382-007_c9bb6350-4876-4aa2-8986-51dc17925315 50382-007 HUMAN OTC DRUG HYDROCORTISONE ACETATE Hydrocortisone Acetate OINTMENT TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part348 Galentic Pharma (India) Private Limited HYDROCORTISONE ACETATE 1 g/100g E 20171231 50382-008_cae22cb8-66e4-4702-80c2-89428b37f1cc 50382-008 HUMAN OTC DRUG bacitracin zinc, neomycin sulfate and polymyxin b sulfate bacitracin zinc, neomycin sulfate and polymyxin b sulfate OINTMENT TOPICAL 20130807 OTC MONOGRAPH FINAL part333B Galentic Pharma (India) Private Limited BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 50382-009_8b6f01c2-5a58-4818-b9f7-22bad9bddbd4 50382-009 HUMAN OTC DRUG Mineral Oil MINERAL OIL ENEMA RECTAL 20130807 OTC MONOGRAPH NOT FINAL part334 Galentic Pharma (India) Priva Te Limited MINERAL OIL 118 g/118mL E 20171231 50382-010_a66e7c0f-e3f8-4b5d-8e07-4522c86b6c38 50382-010 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part348 Galentic Pharma (India) Priva Te Limited HYDROCORTISONE ACETATE 1 g/100g E 20171231 50382-011_646352db-de91-4a3f-9681-ec47226fa11a 50382-011 HUMAN OTC DRUG zinc oxide zinc oxide OINTMENT TOPICAL 20130808 OTC MONOGRAPH FINAL part347 Galentic Pharma (India) Private Limited ZINC OXIDE 1.8 g/100g E 20171231 50382-012_c824ad2f-391a-464f-a444-7b7d43d75038 50382-012 HUMAN OTC DRUG Zinc Oxide and Dimethicone with Dimethicone Zinc Oxide and Dimethicone CREAM TOPICAL 20130808 OTC MONOGRAPH FINAL part347 Galentic Pharma (India) Private Limited ZINC OXIDE; DIMETHICONE 200; 18 mg/g; mg/g E 20171231 50382-013_ce3508ad-18b4-4ddc-8d7f-538484aab8d1 50382-013 HUMAN OTC DRUG Galentic Hydrogel glycerin GEL TOPICAL 20140414 OTC MONOGRAPH FINAL part346 Galentic Pharma (India) Private Limited GLYCERIN 20 g/100g E 20171231 50382-014_1553cbe7-9b76-49f8-9801-e05eb8e3425e 50382-014 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part333C Galentic Pharma (India) Private Limited TOLNAFTATE 10 mg/g N 20181231 50382-015_32a6a611-0832-4549-ac97-5be8d1c6d2c3 50382-015 HUMAN OTC DRUG Muscle Rub MENTHOL, UNSPECIFIED FORM and Methyl Salicylate CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part348 Galentic Pharma (India) Private Limited MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 100; 150 mg/g; mg/g N 20181231 50382-016_1a809c24-349b-4059-ae6e-cb780d2194e4 50382-016 HUMAN OTC DRUG Muscle and Joint Menthol, Unspecified Form GEL TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part348 Galentic Pharma (India) Private Limited MENTHOL, UNSPECIFIED FORM 25 mg/g N 20181231 50382-017_78f04adf-52a6-4702-9180-74a65f2bc864 50382-017 HUMAN OTC DRUG Lubricating Eye Mineral Oil and Petrolatum OINTMENT OPHTHALMIC 20130902 OTC MONOGRAPH FINAL part347 Galentic Pharma (India) Private Limited MINERAL OIL; PETROLATUM 200; 800 mg/g; mg/g N 20191231 50382-020_a3b4a268-805e-4b26-901b-e1237443a5f6 50382-020 HUMAN OTC DRUG Burn Lidocaine Hydrochloride GEL TOPICAL 20170907 OTC MONOGRAPH NOT FINAL part348 Galentic Pharma (India) Private Limited LIDOCAINE HYDROCHLORIDE 20 mg/g N 20181231 50382-022_3aed9595-6b39-4f79-8954-897501645126 50382-022 HUMAN OTC DRUG Burn Lidocaine Hydrochloride and Benzalkonium Chloride CREAM TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part348 Galentic Pharma (India) Private Limited LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE 5; 1.3 mg/g; mg/g N 20191231 50382-023_2fc33045-1fc0-4f5e-bca0-f7552478b1df 50382-023 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20130807 OTC MONOGRAPH FINAL part333B Galentic Pharma (India) Private Limited BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g N 20191231 50382-024_c508160c-72b4-4dba-bbff-56afc659fe31 50382-024 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part348 Galentic Pharma (India) Private Limited HYDROCORTISONE 10 mg/g N 20191231 50382-025_e70ba530-2be3-4ccf-b7f4-e1ea30b8c66e 50382-025 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20130807 OTC MONOGRAPH FINAL part333C Galentic Pharma (India) Private Limited CLOTRIMAZOLE 10 mg/g N 20191231 50382-050_3484819a-ee23-4388-bafa-c3ee839ddae8 50382-050 HUMAN OTC DRUG MICONAZOLE antifungal CREAM TOPICAL 20130718 OTC MONOGRAPH FINAL part333C Galentic Pharma (India) Priva Te Limited MICONAZOLE NITRATE 20 mg/g E 20171231 50382-051_443b48e9-ab2a-4681-ae64-436aa73a504f 50382-051 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20130404 OTC MONOGRAPH FINAL part347 Galentic Pharma (India) Private Limited ZINC OXIDE 200 mg/g N 20181231 50382-051_e1464e9e-9350-4572-ba59-c4c26535fec3 50382-051 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20130719 OTC MONOGRAPH FINAL part347 Galentic Pharma (India) Priva Te Limited ZINC OXIDE 200 mg/g N 20181231 50383-001_a414363e-8491-4f83-ac22-371c577178a4 50383-001 HUMAN OTC DRUG Minoxidil Minoxidil SOLUTION TOPICAL 19961224 ANDA ANDA074731 Hi-Tech Pharmacal Co., Inc. MINOXIDIL 2 g/100mL N 20181231 50383-001_d5595f80-3f73-4f16-a701-1e4276b68b5e 50383-001 HUMAN OTC DRUG Minoxidil Minoxidil SOLUTION TOPICAL 19961224 ANDA ANDA074731 Hi-Tech Pharmacal Co., Inc. MINOXIDIL 2 g/100mL N 20181231 50383-018_39eb84cd-6655-4d8a-b952-6f823f3b5473 50383-018 HUMAN OTC DRUG Eye Wash Eye Wash SOLUTION/ DROPS INTRAOCULAR 19970106 OTC MONOGRAPH FINAL part349 Hi-Tech Pharmacal Co., Inc. WATER 980 mg/mL N 20181231 50383-021_6da53275-f400-4fbe-9159-22fd2377b3cc 50383-021 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20020910 ANDA ANDA075163 Hi-Tech Pharmacal Co., Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 50383-024_0095d1d6-d83e-4e22-aa61-3b4753f0753b 50383-024 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076615 Hi-Tech Pharmacal Co., Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50383-025_10d0fd2b-81f4-4836-b279-cf2b17813eb5 50383-025 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxaxin SOLUTION/ DROPS AURICULAR (OTIC) 20080317 ANDA ANDA076616 Hi-Tech Pharmacal Co., Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50383-040_4157d921-2808-4689-8bbe-d10d718f6f9a 50383-040 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20030326 ANDA ANDA075183 Hi-Tech Pharmacal Co., Inc. PREDNISOLONE SODIUM PHOSPHATE 5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50383-042_67542ba5-0bb2-41a1-bff1-74b4ddb17670 50383-042 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Hi-Tech Pharmacal Co., Inc. PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50383-043_714c12dc-c782-4f01-9fec-4d09bf413f1d 50383-043 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP ORAL 20080208 ANDA ANDA040613 Hi-Tech Pharmacal Co., Inc. HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50383-050_f2ec923a-2b88-43c0-ac2a-7ae20c053039 50383-050 HUMAN PRESCRIPTION DRUG Cimetidine Hydrochloride Oral Solution Cimetidine Hydrochloride Oral Solution SOLUTION ORAL 19971028 ANDA ANDA074664 Hi-Tech Pharmacal Co., Inc. CIMETIDINE HYDROCHLORIDE 300 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50383-051_7a316ed8-68a7-43fa-a247-b72609893a76 50383-051 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SOLUTION ORAL 20110322 ANDA ANDA091078 Hi-Tech Pharmacal Co., Inc. RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50383-062_eda4db26-e020-4ca8-a63f-590484a06824 50383-062 HUMAN OTC DRUG Dextromethorphan HBr and Guaifenesin Dextromethorphan HBr and Guaifenesin SOLUTION ORAL 20120307 OTC MONOGRAPH FINAL part341 Hi-Tech Pharmacal Co., Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 50383-063_4d939198-a09c-46b0-a8fe-fc2b09b5177d 50383-063 HUMAN OTC DRUG Guaifenesin Guaifenesin SOLUTION ORAL 20120307 OTC MONOGRAPH FINAL part341 Hi-Tech Pharmacal Co., Inc. GUAIFENESIN 100 mg/5mL N 20181231 50383-079_646af78f-cb76-4e4a-ae99-5896a9f56fe9 50383-079 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 19960426 ANDA ANDA040119 Hi-Tech Pharmacal Co., Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 50383-087_a3f9be67-29e5-4038-bfc4-150d3a339199 50383-087 HUMAN OTC DRUG Guaiatussin AC guaifenesin and codeine phosphate LIQUID ORAL 20100908 OTC MONOGRAPH FINAL part341 Hi-Tech Pharmacal Co., Inc. CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV N 20181231 50383-171_61fd1e9d-9919-4f59-b810-10230bdd42a0 50383-171 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine SOLUTION ORAL 19860410 NDA NDA019257 Hi-Tech Pharmacal Co., Inc. LEVOCARNITINE 1 g/10mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] N 20181231 50383-172_839b4b25-9dac-4265-82ff-cf822d06330a 50383-172 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine TABLET ORAL 20051101 NDA NDA018948 Hi-Tech Pharmacal Co., Inc. LEVOCARNITINE 330 mg/1 Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] N 20191231 50383-189_3b49883f-27c7-4d28-adf9-5149969e7c80 50383-189 HUMAN PRESCRIPTION DRUG Gatifloxacin Gatifloxacin SOLUTION/ DROPS OPHTHALMIC 20141006 ANDA ANDA203189 Hi-Tech Pharmacal Co., Inc. GATIFLOXACIN ANHYDROUS 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50383-232_903303ea-ad3a-4d4f-9ce2-928effe6ab8e 50383-232 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride Dorzolamide Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20081028 ANDA ANDA077846 Hi-Tech Pharmacal Co., Inc. DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] N 20181231 50383-233_97b39121-fa8b-4190-80ad-d8d035c66fe4 50383-233 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20081028 ANDA ANDA077847 Hi-Tech Pharmacal Co., Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50383-241_6fa23910-d0ee-45cf-997a-22f6587ab034 50383-241 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20120228 ANDA ANDA090601 Hi-Tech Pharmacal Co., Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50383-249_3f300766-1a87-4241-aa89-fb5ee5864248 50383-249 HUMAN PRESCRIPTION DRUG bromfenac bromfenac SOLUTION/ DROPS OPHTHALMIC 20140122 ANDA ANDA203395 Hi-Tech Pharmacal Co., Inc. BROMFENAC SODIUM 1.035 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50383-266_4fc7e152-1d4e-489d-bd00-0b00338b8eba 50383-266 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SOLUTION TOPICAL 20100607 ANDA ANDA074222 Hi-Tech Pharmacal Co., Inc. CLOBETASOL PROPIONATE .4625 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50383-267_9153a74e-b768-4fc6-866b-c5eb8dabb612 50383-267 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20100607 ANDA ANDA074220 Hi-Tech Pharmacal Co., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50383-268_9153a74e-b768-4fc6-866b-c5eb8dabb612 50383-268 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20100607 ANDA ANDA074221 Hi-Tech Pharmacal Co., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50383-269_c2fe3323-7cfd-47b2-9695-ac39ae559f44 50383-269 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate GEL TOPICAL 20100607 ANDA ANDA076141 Hi-Tech Pharmacal Co., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50383-270_38d748cc-331d-4671-b0aa-b17fd0193ed3 50383-270 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate EMULSION TOPICAL 20100607 ANDA ANDA075325 Hi-Tech Pharmacal Co., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50383-282_a2d36cea-f8be-40c5-97ab-deec91fa885c 50383-282 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 Hi-Tech Pharmacal Co., Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50383-283_1272557e-0530-4164-8579-7927b0ec1de7 50383-283 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin SOLUTION/ DROPS OPHTHALMIC 20110210 ANDA ANDA076826 Hi-Tech Pharmacal Co., Inc. LEVOFLOXACIN 5 mg/mL N 20181231 50383-286_261fc07c-b921-482a-8231-4543c6cf9f2b 50383-286 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin SOLUTION ORAL 20110621 ANDA ANDA091678 Hi-Tech Pharmacal Co., Inc. LEVOFLOXACIN 25 mg/mL N 20181231 50383-287_0931b2e5-53b7-482b-af10-96080de7d312 50383-287 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20160107 ANDA ANDA204431 Hi-Tech Pharmacal Co. Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 50383-294_0931b2e5-53b7-482b-af10-96080de7d312 50383-294 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20160107 ANDA ANDA204431 Hi-Tech Pharmacal Co. Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 50383-311_2d14df7a-bb92-4e38-a110-aa38023a2dfb 50383-311 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin SOLUTION ORAL 20110223 ANDA ANDA078974 Hi-Tech Pharmacal Co., Inc. GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50383-419_c6496f76-af80-472f-900a-1eef25de4e2f 50383-419 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20070918 ANDA ANDA078270 Hi-Tech Pharmacal Co., Inc. CICLOPIROX 71.3 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 50383-565_de0cfcaa-6b07-481b-af8e-e3c5c4365f28 50383-565 HUMAN PRESCRIPTION DRUG Neomycin Sulfate Neomycin Sulfate TABLET ORAL 20100312 ANDA ANDA065220 Hi-Tech Pharmacal NEOMYCIN SULFATE 500 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 50383-584_52d4f805-210b-4633-9fdf-c8a2952dee5d 50383-584 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20161128 ANDA ANDA205647 Hi-Tech Pharmacal Co., Inc. IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50383-587_0d649357-80be-426c-87b3-696675bd7478 50383-587 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20120127 ANDA ANDA064042 Hi-Tech Pharmacal Co., Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 50383-618_12bef5ba-d5d3-4b19-8a22-6f2c542ebd76 50383-618 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SOLUTION ORAL 19951117 ANDA ANDA074352 Hi-Tech Pharmacal Co., Inc. LOPERAMIDE HYDROCHLORIDE 1 mg/5mL N 20181231 50383-667_390ccf7a-2bf5-4ba0-9bc4-d0293520e05b 50383-667 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20030925 ANDA ANDA076290 Hi-Tech Pharmacal Co., Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 50383-700_bda03c5e-90ac-496c-964f-00219a152d5d 50383-700 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20080116 ANDA ANDA077570 Hi-Tech Pharmacal Co., Inc. FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50383-705_193c067c-99d4-4ed4-a01a-971af0447979 50383-705 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam CONCENTRATE ORAL 20120130 ANDA ANDA200169 Hi-Tech Pharmacal Co., Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50383-720_209359cf-9007-491e-9675-ad0c8b3a8f20 50383-720 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 19960507 ANDA ANDA074356 Hi-Tech Pharmacal Co., Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 50383-732_5b8e379e-6f2c-4852-88fe-6dc8afccd16f 50383-732 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene SOLUTION TOPICAL 20141006 ANDA ANDA077579 Hi-Tech Pharmacal Co., Inc. CALCIPOTRIENE HYDRATE .05 mg/mL Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 50383-740_4e8265de-7553-44ac-98ca-ddaace18aa56 50383-740 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 19980130 ANDA ANDA074749 Hi-Tech Pharmacal Co., Inc. ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 50383-741_eca182e9-e869-471f-ae39-4e15a5b2bcd8 50383-741 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19980115 ANDA ANDA074543 Hi-Tech Pharmacal Co., Inc. ALBUTEROL SULFATE 5 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 50383-771_b2595e23-d30f-44ac-8125-5ec61871088c 50383-771 HUMAN OTC DRUG Docu Liquid Docusate Sodium LIQUID ORAL 19970801 OTC MONOGRAPH NOT FINAL part334 Hi-Tech Pharmacal Co., Inc. DOCUSATE SODIUM 50 mg/5mL N 20181231 50383-772_319b6093-ed21-4526-b6ed-a9470430ca47 50383-772 HUMAN PRESCRIPTION DRUG Anestacon Lidocaine hydrochloride JELLY TOPICAL 20011105 ANDA ANDA080429 Hi-Tech Pharmacal Co., Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 50383-775_92fca27f-2964-4fc4-a825-84443b5ffad7 50383-775 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 Hi-Tech Pharmacal Co., Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 50383-779_2a039f04-91df-492f-ab04-f9b85d1f3caa 50383-779 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19950703 ANDA ANDA074076 Hi-Tech Pharmacal Co., Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 50383-781_dcadad76-691a-477d-ac38-fc749419396c 50383-781 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 20110323 ANDA ANDA040837 Hi-Tech Pharmacal Co., Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 50383-792_2be4317c-461b-4e7f-a474-3f91164d916d 50383-792 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 19950113 ANDA ANDA074060 Hi-Tech Pharmacal Co., Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50383-795_3649ca34-b4ac-4861-84b1-f8df74166e9d 50383-795 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL; RECTAL 19950703 ANDA ANDA074077 Hi-Tech Pharmacal Co., Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 50383-796_88f90356-87f7-4717-9e57-272cebb7b642 50383-796 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride SOLUTION ORAL 19941028 ANDA ANDA040010 Hi-Tech Pharmacal Co., Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 50383-801_d9d4feb4-61a7-409f-a909-79e8ad3e6d4d 50383-801 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SOLUTION ORAL 19980925 ANDA ANDA040026 Hi-Tech Pharmacal Co., Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 50383-802_9818f555-2084-444c-ae6f-11d49d7d7e2e 50383-802 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Phenylephrine Hydrochloride Promethazine Hydrochloride and Phenylephrine Hydrochloride SYRUP ORAL 20150616 ANDA ANDA040675 Hi-Tech Pharmacal Co., Inc. PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 5 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] N 20181231 50383-803_c07da3e0-db14-4f19-b4dc-b25a6b3289f2 50383-803 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethophan Hydrobromide Promethazine Hydrochloride and Dextromethophan Hydrobromide SOLUTION ORAL 19960731 ANDA ANDA040027 Hi-Tech Pharmacal Co., Inc. PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 6.25; 15 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] N 20181231 50383-804_44349f34-b764-437a-bd6a-196fa2572618 50383-804 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Codeine Phosphate Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 19970826 ANDA ANDA040151 Hi-Tech Pharmacal Co., Inc. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV N 20181231 50383-805_5b6ba06a-1b39-431c-ab33-c1abc026436c 50383-805 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate SYRUP ORAL 20150616 ANDA ANDA040674 Hi-Tech Pharmacal Co., Inc. PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 5; 10 mg/5mL; mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 50383-807_5deef177-0aa4-4bf9-ad05-1d2f59e3678b 50383-807 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride SOLUTION ORAL 19941028 ANDA ANDA074170 Hi-Tech Pharmacal Co., Inc. AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 50383-810_449d2a92-17d6-46a8-90dd-bfaa2463f071 50383-810 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir SUSPENSION ORAL 20050607 ANDA ANDA077026 Hi-Tech Pharmacal Co., Inc. ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50383-823_3caeb6b0-702d-4581-8b10-d913d53cf394 50383-823 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19971229 ANDA ANDA074650 Hi-Tech Pharmacal Co., Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 50383-824_3caeb6b0-702d-4581-8b10-d913d53cf394 50383-824 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19971229 ANDA ANDA074650 Hi-Tech Pharmacal Co., Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 50383-855_e39e6b6a-f449-41fe-92f6-a79de5dab2d1 50383-855 HUMAN PRESCRIPTION DRUG Paregoric Paregoric LIQUID ORAL 20120806 UNAPPROVED DRUG OTHER Hi-Tech Pharmacal Co., Inc. MORPHINE 2 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 50383-859_234460f6-965b-41d1-8655-6a4fdc2eece9 50383-859 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20170609 ANDA ANDA203960 Hi-Tech Pharmacal Co., Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 50383-889_9cdf3d75-ea91-4d23-9697-b004ecb9e6e3 50383-889 HUMAN PRESCRIPTION DRUG Acetic Acid Acetic Acid SOLUTION AURICULAR (OTIC) 20100122 NDA NDA012179 Hi-Tech Pharmacal Co., Inc. ACETIC ACID 20.65 mg/mL N 20191231 50383-901_d21f6fff-111d-4222-a996-b3bfd0f3d6ee 50383-901 HUMAN PRESCRIPTION DRUG Hydrocortisone and Acetic Acid Hydrocortisone and Acetic Acid SOLUTION AURICULAR (OTIC) 20090604 NDA NDA012770 Hi-Tech Pharmacal Co., Inc. ACETIC ACID; HYDROCORTISONE 20.75; 10.375 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50383-913_66f9aec2-8cb1-48f9-9cda-8452cac474aa 50383-913 HUMAN PRESCRIPTION DRUG Famotidine Famotidine POWDER, FOR SOLUTION ORAL 20160316 ANDA ANDA201995 Hi-Tech Pharmacal Co., Inc. FAMOTIDINE 40 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50383-924_d8be28f8-6422-43a3-8d62-1fe32fa8c4ea 50383-924 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 Hi-Tech Pharmacal Co., Inc. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 50383-930_d8be28f8-6422-43a3-8d62-1fe32fa8c4ea 50383-930 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 Hi-Tech Pharmacal Co., Inc. BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 50383-933_acb312b6-f780-4241-a756-2527479f3eb1 50383-933 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20120312 ANDA ANDA040911 Hi-Tech Pharmacal Co., Inc. LIDOCAINE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 50383-955_e9f0104c-2506-4ddb-bae2-342c73a24ee3 50383-955 HUMAN PRESCRIPTION DRUG Trifluridine Trifluridine SOLUTION/ DROPS OPHTHALMIC 20170728 ANDA ANDA205438 Hi-Tech Pharmacal Co., Inc. TRIFLURIDINE 10 mg/mL Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC],Nucleoside Metabolic Inhibitor [EPC],Nucleic Acid Synthesis Inhibitors [MoA] N 20181231 50383-959_f5b06262-82e0-424e-8c8f-35303efd90ac 50383-959 HUMAN PRESCRIPTION DRUG Protriptyline hydrochloride Protriptyline hydrochloride TABLET, FILM COATED ORAL 20131028 ANDA ANDA202220 Hi-Tech Pharmacal Co., Inc. PROTRIPTYLINE HYDROCHLORIDE 5 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50383-960_f5b06262-82e0-424e-8c8f-35303efd90ac 50383-960 HUMAN PRESCRIPTION DRUG Protriptyline hydrochloride Protriptyline hydrochloride TABLET, FILM COATED ORAL 20131028 ANDA ANDA202220 Hi-Tech Pharmacal Co., Inc. PROTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50383-961_bb0767d1-b0f8-4975-bf51-631c9fa1b9bb 50383-961 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20170810 ANDA ANDA208817 Hi-Tech Pharmacal Co., Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 50383-964_d1c542ab-0d9d-488a-b11a-0305d177b0f6 50383-964 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20170807 ANDA ANDA208795 Hi-Tech Pharmacal Co., Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 50383-965_431a06fb-b6e3-4aab-a965-6b90ad8b5aa5 50383-965 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20170706 ANDA ANDA208809 Hi-Tech Pharmacal Co., Inc. MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 50383-979_2ded8c5f-3449-40fb-99a4-89b0fb6f0df7 50383-979 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SHAMPOO TOPICAL 20171030 ANDA ANDA209871 Hi-Tech Pharmacal Co., Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50387-100_bbcf9449-9ed4-43c9-877f-59aa7901e1c8 50387-100 HUMAN OTC DRUG Forest Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 E-House Korea Holdings International STARCH, CORN 3.16 g/4g E 20171231 50387-100_db1381c4-9d07-4daa-9846-ebd3adaefb35 50387-100 HUMAN OTC DRUG Forest Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 E-House Korea Holdings International STARCH, CORN 3.16 g/4g E 20171231 50387-200_19bf408e-ddaa-4b11-8ae7-bc45ce26a846 50387-200 HUMAN OTC DRUG Warm Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 E-House Korea Holdings International STARCH, CORN 3.16 g/4g E 20171231 50387-200_cd5cff0a-ecaa-42a5-8a50-a1fafbf610a6 50387-200 HUMAN OTC DRUG Warm Sap Patch TOPICAL STARCH POULTICE TOPICAL 20100115 OTC MONOGRAPH FINAL part347 E-House Korea Holdings International STARCH, CORN 3.16 g/4g E 20171231 50387-300_19ca3cbb-95e1-4565-975b-3014969fd671 50387-300 HUMAN OTC DRUG BBCREAM TITANIUM DIOXIDE, ETHYLHEXYL METHOXYCINNAMATE CREAM TOPICAL 20110420 OTC MONOGRAPH FINAL part352 E-House Korea Holdings International TITANIUM DIOXIDE; OCTINOXATE 3.04; 1.35 mL/30mL; mL/30mL E 20171231 50390-000_3024fdf8-4958-4df2-83e2-0b86b5fb22dd 50390-000 HUMAN OTC DRUG SATINIQUE ANTI-DANDRUFF for dry, irritated scalp PYRITHIONE ZINC SHAMPOO TOPICAL 20140213 OTC MONOGRAPH FINAL part358H Amway Corp PYRITHIONE ZINC 9.5 mg/mL E 20171231 50390-001_61ceb6f4-3ef4-4675-e053-2991aa0a086e 50390-001 HUMAN OTC DRUG Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Light/Medium ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 Amway Corp ENSULIZOLE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 20; 55; 5; 8.8; 98 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 50390-002_61ceb7b5-8450-1166-e053-2a91aa0a3982 50390-002 HUMAN OTC DRUG Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Medium ENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 Amway Corp ENSULIZOLE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 20; 55; 5; 8.8; 98 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 50390-003_61cedbd3-55c5-393a-e053-2a91aa0a11fe 50390-003 HUMAN OTC DRUG Artistry Exact Fit Longwearing Foundation SPF 15 Broad Spectrum Sunscreen TITANIUM DIOXIDE CREAM TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 Amway Corp TITANIUM DIOXIDE 40.25 mg/mL N 20191231 50390-004_61ceda7f-f5fc-5359-e053-2a91aa0aa875 50390-004 HUMAN OTC DRUG Artistry Beauty Balm Perfecting Primer SPF 35 Broad Spectrum Sunscreen ENSULIZOLE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20150505 OTC MONOGRAPH NOT FINAL part352 Amway Corp ENSULIZOLE; OCTINOXATE; ZINC OXIDE 20; 50; 54.9 mg/mL; mg/mL; mg/mL N 20191231 50390-010_5a03e0a5-3f0e-c998-e053-2991aa0a19e4 50390-010 HUMAN OTC DRUG Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Deep ENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170923 OTC MONOGRAPH NOT FINAL part352 Amway Corp ENSULIZOLE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 20; 55; 5; 84; 98 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 50390-011_5a0437e4-58ae-6dd0-e053-2991aa0a67da 50390-011 HUMAN OTC DRUG Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Med/Deep ENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170923 OTC MONOGRAPH NOT FINAL part352 Amway Corp ENSULIZOLE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 20; 55; 5; 84; 98 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 50390-012_5a043a93-8f8c-1e83-e053-2991aa0afb4e 50390-012 HUMAN OTC DRUG Clear.now Nourish Acne Treatment SALICYLIC ACID LOTION TOPICAL 20170923 OTC MONOGRAPH FINAL part333D Amway Corp SALICYLIC ACID 7 mg/mL N 20181231 50390-013_5a043a93-8f97-1e83-e053-2991aa0afb4e 50390-013 HUMAN OTC DRUG Clear.now Scrub Acne Treatment Wash SALICYLIC ACID LIQUID TOPICAL 20170923 OTC MONOGRAPH FINAL part333D Amway Corp SALICYLIC ACID 20 mg/mL N 20181231 50390-014_5a043a93-8fa2-1e83-e053-2991aa0afb4e 50390-014 HUMAN OTC DRUG Artistry Hydro-V Sheer Weightless Foundation SPF 15 Broad Spectrum Sunscreen OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20170923 OTC MONOGRAPH NOT FINAL part352 Amway Corp OCTINOXATE; ZINC OXIDE 40; 27.4 mg/mL; mg/mL N 20181231 50390-108_61cf1613-b9f6-5fc1-e053-2991aa0aaa74 50390-108 HUMAN OTC DRUG ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum Sunscreen OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part352 Amway Corp OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 68; 45; 126.6; 24.9 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 50390-110_eee8d16c-45bd-40a1-b3ec-f3a5dc3e2131 50390-110 HUMAN OTC DRUG ARTISTRY Time Defiance UV Defense SPF 50 Ultra Facial Sunscreen OCTINOXATE, ZINC OXIDE, OCTISALATE,TITANIUM DIOXIDE CREAM TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Amway Corp OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE 7.5; 6.528; 5; 2.49 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 50390-111_61cf1613-ba07-5fc1-e053-2991aa0aaa74 50390-111 HUMAN OTC DRUG ARTISTRY YOUTH XTEND Lifting Smoothing Foundation Broad Spectrum SPF 20 Sunscreen OCTINOXATE, OXYBENZONE CREAM TOPICAL 20130506 OTC MONOGRAPH NOT FINAL part352 Amway Corp OCTINOXATE; OXYBENZONE 75; 10 mg/mL; mg/mL N 20191231 50390-112_61cf45ba-c2f8-b623-e053-2a91aa0a018e 50390-112 HUMAN OTC DRUG ARTISTRY YOUTH XTEND Protecting Broad Spectrum SPF 15 Sunscreen OCTINOXATE,AVOBENZONE,OXYBENZONE CREAM TOPICAL 20130506 OTC MONOGRAPH NOT FINAL part352 Amway Corp OCTINOXATE; AVOBENZONE; OXYBENZONE 7.5; 3; 1 g/100g; g/100g; g/100g N 20191231 50390-113_61cf498c-d65c-5e26-e053-2991aa0a59c7 50390-113 HUMAN OTC DRUG ARTISTRY YOUTH XTEND Protecting Broad Spectrum SPF 15 OCTINOXATE,AVOBENZONE,OXYBENZONE LOTION TOPICAL 20130506 OTC MONOGRAPH NOT FINAL part352 Amway Corp OCTINOXATE; AVOBENZONE; OXYBENZONE 75; 30; 10 mg/mL; mg/mL; mg/mL N 20191231 50390-701_12838bda-3b39-4415-a956-cff0532dda35 50390-701 HUMAN OTC DRUG Peter Island Continuous Sport Sunscreen SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE SPRAY TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 15; 6; 3; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 50390-702_d42740ea-1ae3-4a4c-a0b3-a780f5a59c96 50390-702 HUMAN OTC DRUG Peter Island Sunscreen SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 13; 4; 3; 5; 7 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 50390-703_7519d11b-d59f-483a-a242-b38dea2f5b35 50390-703 HUMAN OTC DRUG Peter Island Kids Sunscreen SPF 65 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 15; 6; 3; 5; 10 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 50390-704_97e0b336-4a3f-44e1-8fef-69bf4ad865fd 50390-704 HUMAN OTC DRUG Peter Island Sunscreen SPF 70 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 15; 6; 3; 5; 10 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 50390-705_d6626f99-360b-407c-ad4a-c9a9f9258e3c 50390-705 HUMAN OTC DRUG Peter Island Sunscreen SPF 30 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 10; 2; 2; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 50390-706_710ba90e-e8ac-498d-8971-3f6777f9c094 50390-706 HUMAN OTC DRUG Peter Island Baby Sunscreen SPF 50 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 13; 4; 3; 5; 7 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 50390-707_1426a253-7c87-489d-95da-1e078f3c9fab 50390-707 HUMAN OTC DRUG Peter Island Ultimate Sheer Dry Touch Sunscreen SPF 70 HOMOSALATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 AMWAY CORP. HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 15; 6; 3; 5; 2.8 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 50402-100_243d0321-266d-4f8c-a8f4-2c311eb839d1 50402-100 HUMAN PRESCRIPTION DRUG IDkit HP ONE citric acid anhydrous and 13C urea KIT ORAL 20091228 NDA NDA021314 Exalenz Bioscience Ltd. E 20171231 50403-050_c64d5251-a899-4b64-9d6d-d0d285bbe92e 50403-050 HUMAN OTC DRUG IQQU Advanced Sunscreen SPF 50 Octyl Methoxycinnamate and Simmondsia Chinensis Seed Oil and Titanium Dioxide and Tocopheryl Acetate LOTION TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 IQQU USA Co. OCTINOXATE; JOJOBA OIL; TITANIUM DIOXIDE; .ALPHA.-TOCOPHEROL ACETATE, D-; LYCOPENE; SACCHARIDE ISOMERATE .9; 1.5; .9; .3; .3; .3 g/.03g; g/.05g; g/.03g; g/.01g; g/.01g; g/.01g E 20171231 50403-226_ecd5a40f-07db-4814-b08b-710f3a85f10f 50403-226 HUMAN OTC DRUG IQQU Acne Serum Acne Serum LOTION TOPICAL 20090801 UNAPPROVED DRUG OTHER IQQU USA Co. CARNITINE; UBIDECARENONE; LECITHIN, SOYBEAN .012; .0012; .024 g/g; g/g; g/30g E 20171231 50403-999_2083b860-64a8-4ea5-b56f-5af21f82bb2a 50403-999 HUMAN OTC DRUG IQQU Advance Sunscreen Dimethicone and Butyl Methoxydibenzoylmethane and Titanium Dioxide and Octyl Methoxycinnamate LOTION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 IQQU USA Co. DIMETHICONE; AVOBENZONE; TITANIUM DIOXIDE; OCTINOXATE 25; 22; 40; 50 g/mL; g/mL; g/mL; g/mL E 20171231 50405-001_7b0792e4-a4bd-471d-a1b9-6ab737af51f3 50405-001 HUMAN OTC DRUG SohMed Extra Strength Acetaminophen TABLET ORAL 20130825 OTC MONOGRAPH NOT FINAL part343 SOHM Inc. ACETAMINOPHEN 500 mg/1 N 20181231 50405-002_db5fbd25-f7dd-4a7e-8244-4b416e68dede 50405-002 HUMAN OTC DRUG SohMed Acid Reducer ALUMINUM HYDROXIDE and MAGNESIUM CARBONATE TABLET, CHEWABLE ORAL 20130825 OTC MONOGRAPH FINAL part331 SOHM Inc. ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 N 20181231 50405-003_fc1abe03-01c3-4256-88cc-8f12081ce662 50405-003 HUMAN OTC DRUG SohMed Allergy Sinus Acetaminophen, Chlorpheniramine maleate, and Phenylephrine HCl TABLET ORAL 20130825 OTC MONOGRAPH FINAL part341 SOHM Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 50405-004_47dc0428-8164-4ef3-97d4-47e6237dd824 50405-004 HUMAN OTC DRUG SohMed Allergy Diphenhydramine Hydrochloride TABLET ORAL 20130825 OTC MONOGRAPH FINAL part341 SOHM Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50405-005_80ebd529-8309-4e99-aad8-11ea709ca5f7 50405-005 HUMAN OTC DRUG SohMed Alertness Aid Caffeine TABLET ORAL 20130825 OTC MONOGRAPH FINAL part340 SOHM Inc. CAFFEINE 200 mg/1 N 20181231 50405-006_4173790e-f178-44a6-a5fd-0301465ac08f 50405-006 HUMAN OTC DRUG SohMed Cold Relief Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20130825 OTC MONOGRAPH FINAL part341 SOHM Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 50405-007_e8334d2f-c39d-46e5-adf6-74ec49c0c2fa 50405-007 HUMAN OTC DRUG SohMed Pain Relief PM Acetaminophen and Diphenhydramine Hydrochloride TABLET ORAL 20130825 OTC MONOGRAPH NOT FINAL part343 SOHM Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 50405-008_53f2e6c3-b328-4867-a442-3bc74cfaf799 50405-008 HUMAN OTC DRUG SohMed Pain Reliever Acetaminophen, Aspirin, and Caffeine TABLET ORAL 20130825 OTC MONOGRAPH NOT FINAL part343 SOHM Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 50405-009_13d67cad-bab8-4bae-bbe9-d3e4a14bd501 50405-009 HUMAN OTC DRUG SohMed Sinus Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20130825 OTC MONOGRAPH FINAL part341 Sohm Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 50405-110_3c64e61b-aa7c-4978-8def-10647713dae3 50405-110 HUMAN OTC DRUG Salic-2 Salicylic Acid GEL TOPICAL 20131115 OTC MONOGRAPH FINAL part333D SOHM Inc. SALICYLIC ACID 1.2 g/60g N 20181231 50409-514_86f6b0d9-e0f9-4042-9e9c-62607f7679c6 50409-514 HUMAN OTC DRUG Native Green Foaming Hand Sanitizer benzalkonium chloride SOLUTION TOPICAL 20100421 OTC MONOGRAPH NOT FINAL part333 Native Green BENZALKONIUM CHLORIDE 1 g/1000mL E 20171231 50410-010_8ebf53d8-d29b-46ce-a142-6f94cfffc3db 50410-010 HUMAN OTC DRUG Belucie Luxury Essential Twin Pact NO21 SPF25 PA PLUS PLUS Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20120301 OTC MONOGRAPH FINAL part352 KIMJEONGMOON ALOE CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .744; .48; .235 g/12g; g/12g; g/12g N 20181231 50410-020_f404b40e-6ba1-47d7-a0d0-179c21d11c35 50410-020 HUMAN OTC DRUG Belucie Luxury Essential Twin Pact NO23 SPF25 PA PLUS PLUS Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20120301 OTC MONOGRAPH FINAL part352 KIMJEONGMOON ALOE CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .744; .48; .235 g/12g; g/12g; g/12g N 20181231 50410-030_f0420d22-97a6-4ad2-8e95-e9fa1ec0d74b 50410-030 HUMAN OTC DRUG Belucie Luxury Essential foundation BB ANTI WRINKLE SPF20 PA PLUS PLUS Titanium Dioxide CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part352 KIMJEONGMOON ALOE CO., LTD. TITANIUM DIOXIDE 3.25 g/35mL N 20181231 50410-040_b7676b00-faaf-41c5-bf78-ebe22d79a552 50410-040 HUMAN OTC DRUG Belucie Luxury Timeless Golden Age Emulsion Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 KIMJEONGMOON ALOE CO., LTD. DIMETHICONE 2.93 g/125mL N 20181231 50410-050_dd2997d9-df75-4445-9122-a9f5b864c317 50410-050 HUMAN OTC DRUG Belucie Luxury Timeless Golden Age Eye Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 KIMJEONGMOON ALOE CO., LTD. DIMETHICONE 1.5 g/30mL N 20181231 50410-060_eb6747f2-2ecb-4a82-ae42-38ef221cfe29 50410-060 HUMAN OTC DRUG Belucie Luxury Timeless Golden Age Day Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 KIMJEONGMOON ALOE CO., LTD. DIMETHICONE .5 g/50mL N 20181231 50410-070_383f5b74-e7c8-487f-9bbc-5e04f9b0694c 50410-070 HUMAN OTC DRUG Belucie Luxury Timeless Golden Age Night Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 KIMJEONGMOON ALOE CO., LTD. DIMETHICONE .5 g/50mL N 20181231 50410-080_2a1ef280-12ba-401d-a02c-27cc07eb2252 50410-080 HUMAN OTC DRUG Sereve Professional Scalp PYRITHIONE ZINC SHAMPOO TOPICAL 20150102 OTC MONOGRAPH FINAL part358H Kimjeongmoon Aloe Co., Ltd. PYRITHIONE ZINC 5 g/250g N 20181231 50410-090_0c6e0cdc-aa1d-40b3-ac5d-31ed48382704 50410-090 HUMAN OTC DRUG Belucie Luxury Shinning Foundation BC Titanium Dioxide CREAM TOPICAL 20150102 OTC MONOGRAPH NOT FINAL part352 Kimjeongmoon Aloe Co., Ltd. TITANIUM DIOXIDE 3.69 g/40g N 20181231 50414-100_ac63737f-53f9-4668-8921-78f25a44f20b 50414-100 HUMAN OTC DRUG Hand Gel Prolim Instant Hand Sanitizer Alcohol GEL TOPICAL 20100310 OTC MONOGRAPH NOT FINAL part333 Prolim Quimica Avancada Ltda. ALCOHOL .7 mg/mL E 20171231 50419-171_a4e10546-4306-44f4-b670-e203d495e794 50419-171 HUMAN PRESCRIPTION DRUG Stivarga regorafenib TABLET, FILM COATED ORAL 20120927 NDA NDA203085 Bayer HealthCare Pharmaceuticals Inc. REGORAFENIB MONOHYDRATE 40 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 50419-188_130fbcc6-b111-43c2-81a6-9c961033878f 50419-188 HUMAN PRESCRIPTION DRUG Magnevist Gadopentetate dimeglumine INJECTION INTRAVENOUS 20140611 NDA NDA019596 Bayer HealthCare Pharmaceuticals Inc. GADOPENTETATE DIMEGLUMINE 469.01 mg/mL N 20181231 50419-188_640b8995-8945-4f87-b40d-733786fdc88e 50419-188 HUMAN PRESCRIPTION DRUG Magnevist gadopentetate dimeglumine INJECTION INTRAVENOUS 20101214 NDA NDA021037 Bayer HealthCare Pharmaceuticals Inc. GADOPENTETATE DIMEGLUMINE 469.01 mg/mL N 20181231 50419-208_f45869fa-8747-4375-86cd-bfd46620d088 50419-208 HUMAN PRESCRIPTION DRUG Xofigo Radium Ra 223 dichloride INJECTION INTRAVENOUS 20130520 NDA NDA203971 Bayer HealthCare Pharmaceuticals Inc. RADIUM RA-223 DICHLORIDE 30 uCi/mL Radioactive alpha-Particle Emitting Therapeutic Agent [EPC],alpha-Particle Emitting Activity [MoA] N 20181231 50419-250_55cfe406-6338-4ae0-8313-88a1466ef7d9 50419-250 HUMAN PRESCRIPTION DRUG Adempas riociguat TABLET, FILM COATED ORAL 20131008 NDA NDA204819 Bayer HealthCare Pharmaceuticals Inc. RIOCIGUAT .5 mg/1 Guanylate Cyclase Stimulators [MoA],Soluble Guanylate Cyclase Stimulator [EPC] N 20181231 50419-251_55cfe406-6338-4ae0-8313-88a1466ef7d9 50419-251 HUMAN PRESCRIPTION DRUG Adempas riociguat TABLET, FILM COATED ORAL 20131008 NDA NDA204819 Bayer HealthCare Pharmaceuticals Inc. RIOCIGUAT 1 mg/1 Guanylate Cyclase Stimulators [MoA],Soluble Guanylate Cyclase Stimulator [EPC] N 20181231 50419-252_55cfe406-6338-4ae0-8313-88a1466ef7d9 50419-252 HUMAN PRESCRIPTION DRUG Adempas riociguat TABLET, FILM COATED ORAL 20131008 NDA NDA204819 Bayer HealthCare Pharmaceuticals Inc. RIOCIGUAT 1.5 mg/1 Guanylate Cyclase Stimulators [MoA],Soluble Guanylate Cyclase Stimulator [EPC] N 20181231 50419-253_55cfe406-6338-4ae0-8313-88a1466ef7d9 50419-253 HUMAN PRESCRIPTION DRUG Adempas riociguat TABLET, FILM COATED ORAL 20131008 NDA NDA204819 Bayer HealthCare Pharmaceuticals Inc. RIOCIGUAT 2 mg/1 Guanylate Cyclase Stimulators [MoA],Soluble Guanylate Cyclase Stimulator [EPC] N 20181231 50419-254_55cfe406-6338-4ae0-8313-88a1466ef7d9 50419-254 HUMAN PRESCRIPTION DRUG Adempas riociguat TABLET, FILM COATED ORAL 20131008 NDA NDA204819 Bayer HealthCare Pharmaceuticals Inc. RIOCIGUAT 2.5 mg/1 Guanylate Cyclase Stimulators [MoA],Soluble Guanylate Cyclase Stimulator [EPC] N 20181231 50419-320_cb749f4d-2b5a-4d49-9836-7274eb58f152 50419-320 HUMAN PRESCRIPTION DRUG EOVIST Gadoxetate Disodium INJECTION, SOLUTION INTRAVENOUS 20080703 NDA NDA022090 Bayer HealthCare Pharmaceuticals Inc. GADOXETATE DISODIUM 181.43 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] N 20181231 50419-325_f613ff35-06d2-469a-89c2-88a132ed3b8c 50419-325 HUMAN PRESCRIPTION DRUG Gadavist gadobutrol INJECTION INTRAVENOUS 20110314 NDA NDA201277 Bayer HealthCare Pharmaceuticals Inc. GADOBUTROL 604.72 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] N 20181231 50419-325_f6f8452e-7765-485f-be10-7570775130c2 50419-325 HUMAN PRESCRIPTION DRUG Gadavist gadobutrol INJECTION INTRAVENOUS 20110314 NDA NDA201277 Bayer HealthCare Pharmaceuticals Inc. GADOBUTROL 604.72 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] N 20181231 50419-342_2489e7db-08dc-4023-8265-66e0424200ef 50419-342 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL 20091230 NDA NDA021425 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 498.72 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 50419-342_5c21072d-c219-406e-97d9-e8be8cdc28e2 50419-342 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL; INTRAVENOUS 20091230 NDA NDA020220 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 498.72 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 50419-344_2489e7db-08dc-4023-8265-66e0424200ef 50419-344 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL 20091230 NDA NDA021425 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 623.4 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 50419-344_5c21072d-c219-406e-97d9-e8be8cdc28e2 50419-344 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL; INTRAVENOUS 20091230 NDA NDA020220 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 623.4 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 50419-346_2489e7db-08dc-4023-8265-66e0424200ef 50419-346 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL 20091230 NDA NDA021425 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 768.86 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 50419-346_5c21072d-c219-406e-97d9-e8be8cdc28e2 50419-346 HUMAN PRESCRIPTION DRUG Ultravist iopromide INJECTION INTRA-ARTERIAL; INTRAVENOUS 20091230 NDA NDA020220 Bayer HealthCare Pharmaceuticals Inc. IOPROMIDE 768.86 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 50419-385_f372a5e6-a0f0-44e8-8d79-f5a616ea207b 50419-385 HUMAN PRESCRIPTION DRUG ALIQOPA copanlisib INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170914 NDA NDA209936 Bayer HealthCare Pharmaceuticals Inc. COPANLISIB 15 mg/mL Kinase Inhibitor [EPC],Kinase Inhibitors [MoA] N 20181231 50419-402_39f574dc-19af-4ea9-b129-32a95ceceba0 50419-402 HUMAN PRESCRIPTION DRUG Yasmin drospirenone and ethinyl estradiol KIT 20010511 NDA NDA021098 Bayer HealthCare Pharmaceuticals Inc. N 20181231 50419-403_919376d4-f719-43dd-98ee-84c75d358348 50419-403 HUMAN PRESCRIPTION DRUG Safyral Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium KIT 20120213 NDA NDA022574 Bayer HealthCare Pharmaceuticals Inc. N 20181231 50419-405_1092ba3a-c20f-49f2-a4c9-e3a5489992ef 50419-405 HUMAN PRESCRIPTION DRUG Yaz Drospirenone and ethinyl estradiol KIT 20060316 NDA NDA021676 Bayer HealthCare Pharmaceuticals Inc. N 20181231 50419-407_08854504-cbbf-4c87-b91a-df25d41a3418 50419-407 HUMAN PRESCRIPTION DRUG Beyaz Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium KIT 20101007 NDA NDA022532 Bayer HealthCare Pharmaceuticals Inc. N 20181231 50419-409_395f9953-7cd8-4b9c-ac73-283716cae7a6 50419-409 HUMAN PRESCRIPTION DRUG Natazia estradiol valerate and estradiol valerate/dienogest KIT 20100506 NDA NDA022252 Bayer HealthCare Pharmaceuticals Inc. N 20181231 50419-422_c21cce8b-a5e4-4142-b17f-cbbc025b73ec 50419-422 HUMAN PRESCRIPTION DRUG Skyla Levonorgestrel INTRAUTERINE DEVICE INTRAUTERINE 20130111 NDA NDA203159 Bayer HealthCare Pharmaceuticals Inc. LEVONORGESTREL 13.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] N 20181231 50419-423_7e8d55c2-40b0-4e5c-ae9c-1590e0bdce80 50419-423 HUMAN PRESCRIPTION DRUG Mirena Levonorgestrel INTRAUTERINE DEVICE INTRAUTERINE 20091001 NDA NDA021225 Bayer HealthCare Pharmaceuticals Inc. LEVONORGESTREL 52 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] N 20181231 50419-424_67e4ef32-3fc6-4897-85fe-279c8fa9d712 50419-424 HUMAN PRESCRIPTION DRUG Kyleena Levonorgestrel INTRAUTERINE DEVICE INTRAUTERINE 20160919 NDA NDA208224 Bayer HealthCare Pharmaceuticals Inc. LEVONORGESTREL 19.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] N 20181231 50419-451_fea9e359-414a-42a5-a190-c30b83a472ad 50419-451 HUMAN PRESCRIPTION DRUG Climara Estradiol PATCH TRANSDERMAL 19941222 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50419-452_fea9e359-414a-42a5-a190-c30b83a472ad 50419-452 HUMAN PRESCRIPTION DRUG Climara Estradiol PATCH TRANSDERMAL 19941222 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50419-453_fea9e359-414a-42a5-a190-c30b83a472ad 50419-453 HUMAN PRESCRIPTION DRUG Climara Estradiol PATCH TRANSDERMAL 19980323 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50419-454_fea9e359-414a-42a5-a190-c30b83a472ad 50419-454 HUMAN PRESCRIPTION DRUG Climara Estradiol PATCH TRANSDERMAL 19990305 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50419-455_5e70b657-4dd0-434f-8a4a-c25fc8bfb06a 50419-455 HUMAN PRESCRIPTION DRUG Menostar estradiol PATCH TRANSDERMAL 20040608 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL 14 ug/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50419-456_fea9e359-414a-42a5-a190-c30b83a472ad 50419-456 HUMAN PRESCRIPTION DRUG Climara Estradiol PATCH TRANSDERMAL 20030527 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50419-459_fea9e359-414a-42a5-a190-c30b83a472ad 50419-459 HUMAN PRESCRIPTION DRUG Climara Estradiol PATCH TRANSDERMAL 20080103 NDA NDA020375 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL .06 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50419-482_28511b4c-595e-4229-bd8f-c5b7cd264ace 50419-482 HUMAN PRESCRIPTION DRUG Angeliq drospirenone and estradiol TABLET, FILM COATED ORAL 20120229 NDA NDA021355 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL; DROSPIRENONE .5; .25 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 50419-483_28511b4c-595e-4229-bd8f-c5b7cd264ace 50419-483 HUMAN PRESCRIPTION DRUG Angeliq drospirenone and estradiol TABLET, FILM COATED ORAL 20051128 NDA NDA021355 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL; DROSPIRENONE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 50419-488_c614a52e-7ba4-4adb-b11c-d34bc7165dd6 50419-488 HUMAN PRESCRIPTION DRUG Nexavar sorafenib TABLET, FILM COATED ORAL 20051220 NDA NDA021923 Bayer HealthCare Pharmaceuticals Inc. SORAFENIB 200 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 50419-491_fff84920-33e6-4075-a547-bef529dbe2a1 50419-491 HUMAN PRESCRIPTION DRUG Climara Pro Estradiol and Levonorgestrel PATCH TRANSDERMAL 20031121 NDA NDA021258 Bayer HealthCare Pharmaceuticals Inc. ESTRADIOL; LEVONORGESTREL .045; .015 mg/d; mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] N 20181231 50419-524_c49f770b-f578-4ce7-a220-9661fcda0722 50419-524 HUMAN PRESCRIPTION DRUG Betaseron interferon beta-1b KIT 20090709 BLA BLA103471 Bayer HealthCare Pharmaceuticals Inc. N 20181231 50419-530_b4a8c1c4-6aa4-4deb-919d-a7c4b8d97279 50419-530 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 19991210 NDA NDA021085 Bayer HealthCare Pharmaceuticals Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50419-537_b4a8c1c4-6aa4-4deb-919d-a7c4b8d97279 50419-537 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20011130 NDA NDA021277 Bayer HealthCare Pharmaceuticals Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/250mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50419-747_3c99216b-a7a1-48af-8dea-00815d6091dd 50419-747 HUMAN PRESCRIPTION DRUG Biltricide praziquantel TABLET, FILM COATED ORAL 20110421 NDA NDA018714 Bayer HealthCare Pharmaceuticals Inc. PRAZIQUANTEL 600 mg/1 Antihelminthic [EPC] N 20181231 50419-754_b1f6573e-e634-4757-ad42-8c5487433a78 50419-754 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 19871022 NDA NDA019537 Bayer HealthCare Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50419-758_b1f6573e-e634-4757-ad42-8c5487433a78 50419-758 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 19871022 NDA NDA019537 Bayer HealthCare Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50419-759_f94f3800-252e-4b03-823a-099d24abc301 50419-759 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin SOLUTION, CONCENTRATE INTRAVENOUS 20090422 NDA NDA019857 Bayer HealthCare Pharmaceuticals Inc. CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50419-773_b1f6573e-e634-4757-ad42-8c5487433a78 50419-773 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin KIT 19970926 NDA NDA020780 Bayer HealthCare Pharmaceuticals Inc. N 20181231 50419-777_b1f6573e-e634-4757-ad42-8c5487433a78 50419-777 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin KIT 19970926 NDA NDA020780 Bayer HealthCare Pharmaceuticals Inc. N 20181231 50419-788_6a45ebbd-49c4-4177-8ee3-ad4e02b780da 50419-788 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121001 NDA NDA021473 Bayer HealthCare Pharmaceuticals Inc. CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 212.6; 287.5 mg/1; 1/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50419-789_6a45ebbd-49c4-4177-8ee3-ad4e02b780da 50419-789 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121001 NDA NDA021473 Bayer HealthCare Pharmaceuticals Inc. CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 452.2; 574.9 mg/1; 1/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50419-825_64b1f2d1-87ab-4d10-87e3-5c6e5c982371 50419-825 HUMAN PRESCRIPTION DRUG Finacea azelaic acid GEL TOPICAL 20021224 NDA NDA021470 Bayer HealthCare Pharmaceuticals Inc. AZELAIC ACID .15 g/g Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] N 20181231 50419-828_0e276ec9-8b14-4618-8219-5f3ad4bbc273 50419-828 HUMAN PRESCRIPTION DRUG DESONATE desonide GEL TOPICAL 20061020 NDA NDA021844 Bayer HealthCare Pharmaceuticals Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50419-829_7c4a2987-ebe5-403c-b9a1-1bc82334983c 50419-829 HUMAN PRESCRIPTION DRUG FINACEA FOAM azelaic acid AEROSOL, FOAM TOPICAL 20150803 NDA NDA207071 Bayer HealthCare Pharmaceuticals Inc. AZELAIC ACID .15 g/g Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] N 20181231 50419-861_fb9cf098-681d-461c-a6fa-3eb1168d127c 50419-861 HUMAN PRESCRIPTION DRUG Precose Acarbose TABLET ORAL 20080130 NDA NDA020482 Bayer HealthCare Pharmaceuticals Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 50419-862_fb9cf098-681d-461c-a6fa-3eb1168d127c 50419-862 HUMAN PRESCRIPTION DRUG Precose Acarbose TABLET ORAL 20080130 NDA NDA020482 Bayer HealthCare Pharmaceuticals Inc. ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 50419-863_fb9cf098-681d-461c-a6fa-3eb1168d127c 50419-863 HUMAN PRESCRIPTION DRUG Precose Acarbose TABLET ORAL 20080130 NDA NDA020482 Bayer HealthCare Pharmaceuticals Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 50421-002_0c57f630-0294-41c0-b423-a4cb1d4c3f40 50421-002 HUMAN OTC DRUG Camphor, Menthol Camphor, Menthol GEL TOPICAL 20100113 OTC MONOGRAPH FINAL part348 Active & Innovative Inc. CAMPHOR; MENTHOL 3.4; 8.5 g/85g; g/85g E 20171231 50421-004_7576e9e6-fcc8-437e-bbd4-3e6a4b2dcb73 50421-004 HUMAN OTC DRUG Camphor, Menthol Camphor, Menthol OINTMENT TOPICAL 20100113 OTC MONOGRAPH FINAL part348 Active & Innovative Inc. CAMPHOR; MENTHOL 4.6; 4.6 g/115g; g/115g E 20171231 50425-010_6027cb7f-178d-5cd5-e053-2a91aa0a08d5 50425-010 HUMAN OTC DRUG Scrub Care Povidone Iodine Cleansing Scrub povidone iodine SOLUTION TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part333A CareFusion 213 LLC POVIDONE-IODINE 7.5 mg/mL N 20181231 50425-011_60276eec-6a33-71f5-e053-2a91aa0af483 50425-011 HUMAN OTC DRUG Scrub Care Povidone Iodine Topical Paint providone iodine SOLUTION TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part333A CareFusion 213 LLC POVIDONE-IODINE 10 mg/mL N 20181231 50428-0030_285f23e4-84e6-4930-ba12-c7626713d2cb 50428-0030 HUMAN OTC DRUG Alcohol Wipe Isopropyl Alcohol SWAB TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part333A Dorel Juvenile Group ISOPROPYL ALCOHOL .7 mL/1 N 20181231 50428-3001_51c10961-bcf8-49d1-9b56-4825290b319e 50428-3001 HUMAN OTC DRUG Naturals by Safety 1st Zinc Oxide OINTMENT TOPICAL 20100201 OTC MONOGRAPH FINAL part347 Dorel Juvenile Group ZINC OXIDE 8.8 g/88mL E 20171231 50435-100_480c58fe-de75-70b3-e054-00144ff8d46c 50435-100 HUMAN OTC DRUG Virx Hand Sanitizer Liquid Alcohol GEL TOPICAL 20170208 OTC MONOGRAPH NOT FINAL part333E Filo America ALCOHOL 62 g/100mL N 20181231 50435-101_480c56da-9dbe-708a-e054-00144ff8d46c 50435-101 HUMAN OTC DRUG Virx Hand Sanitizer Liquid Alcohol GEL TOPICAL 20170208 OTC MONOGRAPH NOT FINAL part333E Filo America ALCOHOL 62 g/100mL N 20181231 50435-200_5e704f71-e963-5d97-e053-2991aa0a89d2 50435-200 HUMAN OTC DRUG Royal Alcohol Cleansing ISOPROPYL ALCOHOL PATCH TOPICAL 20171111 OTC MONOGRAPH NOT FINAL part333A Filo America ISOPROPYL ALCOHOL 70 g/100g N 20181231 50436-0006_72dbd8d2-7fd6-4a0b-82ca-02a5318acf9b 50436-0006 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 Unit Dose Services CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50436-0007_9f16f3a0-f0db-4bb8-91a7-92349412d335 50436-0007 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Unit Dose Services ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 50436-0008_9f16f3a0-f0db-4bb8-91a7-92349412d335 50436-0008 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Unit Dose Services ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 50436-0014_ab189210-7a46-4cd6-bf2b-e456f351bae4 50436-0014 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 Unit Dose Services MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 50436-0018_6ffccdca-0b3b-47bf-b89e-9af6f2b43181 50436-0018 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Unit Dose Services DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-0019_6ffccdca-0b3b-47bf-b89e-9af6f2b43181 50436-0019 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Unit Dose Services DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-0022_9fce4392-db82-4386-bed5-e882faded707 50436-0022 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Unit Dose Services LEVOFLOXACIN 500 mg/1 N 20181231 50436-0025_bc11bde2-384f-4b42-a352-4d2e0ef80d70 50436-0025 HUMAN PRESCRIPTION DRUG Mupirocin mupirocin OINTMENT TOPICAL 20051130 ANDA ANDA065192 Unit Dose Services MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 50436-0026_96af229a-fee6-4de8-9dac-fb339ca79330 50436-0026 HUMAN PRESCRIPTION DRUG FROVA frovatriptan succinate TABLET, FILM COATED ORAL 20011108 NDA NDA021006 Unit Dose Services FROVATRIPTAN SUCCINATE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 50436-0029_54999e35-3dc9-4fd8-8d34-7ce496d21be0 50436-0029 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Unit Dose Services AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50436-0031_1c1d6b74-9697-4fd6-b832-e32ea5546b29 50436-0031 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Unit Dose Services AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50436-0041_027761e5-46c8-44ed-97c6-0a4d37984969 50436-0041 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20030501 ANDA ANDA076004 Unit Dose Services ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-0053_c48b4d9f-e78d-4b0c-895f-858092194b6b 50436-0053 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Unit Dose Services ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-0054_ff3894ec-fd44-4499-b70a-3a696b7b7201 50436-0054 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Unit Dose Services ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-0065_0385b658-c242-4bba-9d68-afdb4730b118 50436-0065 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Unit Dose Services OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-0098_948d530d-990d-4abe-98e6-90b4da6eaaa8 50436-0098 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Unit Dose Services MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-0102_39fbd627-211b-48b7-bfb5-df0ab4888762 50436-0102 HUMAN OTC DRUG Promolaxin Docusate sodium TABLET ORAL 20110415 OTC MONOGRAPH NOT FINAL part334 Unit Dose Services DOCUSATE SODIUM 100 mg/1 N 20181231 50436-0106_78a60007-40e0-49aa-9cc6-a6d0e688afd1 50436-0106 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19880225 20180430 ANDA ANDA062881 Unit Dose Services AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50436-0107_26bd4e89-63a7-4657-8953-d108ec052e96 50436-0107 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20080311 ANDA ANDA065470 Unit Dose Services MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 50436-0108_edbdc0b0-b98a-47c0-a370-4b55d29dc8d6 50436-0108 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20080311 ANDA ANDA065470 Unit Dose Services MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 50436-0109_eea1d781-b26f-4995-bfdd-a44b84844119 50436-0109 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 Unit Dose Services HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50436-0112_784a4523-f9c6-4d5e-adc8-f9701bd7b39f 50436-0112 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20091030 ANDA ANDA065123 Unit Dose Services MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 50436-0116_b0a2a7ca-8b8a-4a25-ac78-92f24db5091f 50436-0116 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Extended-Release Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111206 ANDA ANDA078148 Unit Dose Services ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 50436-0117_51a8f729-cedf-4974-b630-4528f2222f5a 50436-0117 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Unit Dose Services CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50436-0119_9f7a82cb-cb37-48c7-bed5-993fe0c94573 50436-0119 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 Unit Dose Services TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50436-0120_5bc72c7a-5bb8-4c00-b047-514727e6e475 50436-0120 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-0121_f1b8bed1-9e4d-49a1-b992-5537889663b2 50436-0121 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-0122_7c6dcb63-555c-421b-abb5-bd7efe8186bf 50436-0122 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-0124_2d0873db-e414-47c0-ab82-483bdbcde47c 50436-0124 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-0125_3f31cba1-f740-4843-b198-d06f59130362 50436-0125 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-0126_c3bd926e-5274-42be-88e6-b4d2051d5d42 50436-0126 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Unit Dose Services GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-0127_c559529b-a79e-494e-b83d-7b1fea7201bf 50436-0127 HUMAN OTC DRUG ASPIRIN ENTERIC COATED ASPIRIN TABLET, COATED ORAL 20150619 OTC MONOGRAPH NOT FINAL part343 Unit Dose Services ASPIRIN 81 mg/1 N 20191231 50436-0128_3afa1966-3613-4e1b-b9ab-5b2712df183e 50436-0128 HUMAN OTC DRUG Aspir Low Aspirin TABLET ORAL 20110524 OTC MONOGRAPH FINAL part343 Unit Dose Services ASPIRIN 81 mg/1 N 20181231 50436-0131_44c61b5f-6100-4396-9219-510cc5198b3f 50436-0131 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Unit Dose Services ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 50436-0132_45e452bf-f06c-4f85-ba9f-d51c7fadc497 50436-0132 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Unit Dose Services ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 50436-0133_39d8379b-aa65-4a42-b0e5-13ab68e25573 50436-0133 HUMAN PRESCRIPTION DRUG ondansetron ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Unit Dose Services ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 50436-0134_83aa2360-ad96-400f-88f9-80208901b89e 50436-0134 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Unit Dose Services ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 50436-0136_e05a6f61-027a-4021-a307-3f75cf7eb59d 50436-0136 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE Tramadol hydrochloride TABLET ORAL 20150522 ANDA ANDA091498 Unit Dose Services TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50436-0139_9327804a-3908-401b-9b06-a55d9b630462 50436-0139 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Unit Dose Services TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-0146_c45d7a7f-d9cf-42d1-9919-ad90c3e3a017 50436-0146 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA076048 Unit Dose Services OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-0149_35004c15-2ff1-4184-b6cb-4d3ec7af6098 50436-0149 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Unit Dose Services LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50436-0155_f3fcf2c8-d953-43fb-ac35-8fb5a9250599 50436-0155 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Unit Dose Services CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 50436-0156_ce240ef3-8770-4579-8b72-0d080b4dde93 50436-0156 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Unit Dose Services OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 50436-0157_d84bfec2-52fe-4083-a052-7d8df4348a7c 50436-0157 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 Unit Dose Services POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 50436-0158_5602fce7-0b6a-4e98-85df-ed3c8e97bc26 50436-0158 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Unit Dose Services OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 50436-0160_6d0c44d2-6414-4c05-985a-8688d2d104fb 50436-0160 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Unit Dose Services HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 50436-0165_12eb3b1e-df09-43e8-be5f-55e765790b61 50436-0165 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services METHYL SALICYLATE; MENTHOL; CAPSAICIN 18; 6; .015 mL/60mL; mL/60mL; mL/60mL N 20181231 50436-0170_9c2d7add-a0bc-48fc-9c98-b1c99d6393c6 50436-0170 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130321 ANDA ANDA202389 Unit Dose Services ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-0171_4ad875c6-37c4-4a39-803c-120c04c74ca9 50436-0171 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Unit Dose Services FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 50436-0172_401427a8-9e96-4bb1-ba27-f72bdcc9445e 50436-0172 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Unit Dose Services FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 50436-0173_cb93f0b7-a534-433f-aa0f-86fee6d553e6 50436-0173 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Unit Dose Services FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 50436-0174_5311688b-a04d-482a-b12f-b2dda2535489 50436-0174 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141226 ANDA ANDA202446 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-0175_5311688b-a04d-482a-b12f-b2dda2535489 50436-0175 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-0180_8e5be629-01f8-4fe1-820a-c2c282d6bf3a 50436-0180 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20110608 ANDA ANDA090480 Unit Dose Services MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 50436-0187_59402cab-f387-452a-bcf9-af77daa95ebe 50436-0187 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Unit Dose Services ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 50436-0188_5bc3d304-da41-470f-8005-c3dfa7c0d244 50436-0188 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Unit Dose Services NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-0190_5bc3d304-da41-470f-8005-c3dfa7c0d244 50436-0190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Unit Dose Services NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-0193_43f0f104-7592-444b-a118-13c2e848f74f 50436-0193 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Unit Dose Services ESZOPICLONE 3 mg/1 N 20181231 50436-0195_a0eabb3a-fe54-4d37-9d54-f2e8a89a65e5 50436-0195 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960917 ANDA ANDA074569 Unit Dose Services CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-0201_2dbf2711-d07e-45ae-9694-a9a678d61854 50436-0201 HUMAN PRESCRIPTION DRUG Provigil Modafinil TABLET ORAL 19990215 NDA NDA020717 Unit Dose Services MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 50436-0210_ca939814-2dff-4692-a480-88fe35187a83 50436-0210 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20080320 ANDA ANDA077689 Unit Dose Services CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50436-0223_6e765ce1-fd04-4918-a89b-7b4ac0c8d7bf 50436-0223 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Unit Dose Services GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-0224_6e765ce1-fd04-4918-a89b-7b4ac0c8d7bf 50436-0224 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Unit Dose Services GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-0226_b91095dd-3a7d-4296-b4a5-c7fbd70bcac0 50436-0226 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Unit Dose Services DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 50436-0227_7e30c07f-5581-40f5-9e59-05d9001b0e4d 50436-0227 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 Unit Dose Services METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20191231 50436-0248_d1d78349-7612-4471-aa7c-b57372bf050e 50436-0248 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20041216 ANDA ANDA076706 Unit Dose Services METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50436-0250_e4b1be0b-1dab-4945-bd40-30e0922e6852 50436-0250 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040876 Unit Dose Services PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-0251_94a44a05-8615-4f00-a38d-db8a8ddf60e0 50436-0251 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Unit Dose Services TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50436-0252_94a44a05-8615-4f00-a38d-db8a8ddf60e0 50436-0252 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Unit Dose Services TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50436-0253_6bd8528a-f012-4785-9cde-a8718cfc647c 50436-0253 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Unit Dose Services RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50436-0262_848a08b3-babc-445e-87e3-0d1c1e368146 50436-0262 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Unit Dose Services ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-0263_8176d432-b0d2-44b5-a335-e2cc47cc224d 50436-0263 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980430 ANDA ANDA075078 Unit Dose Services ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-0264_9c0d464b-2cdf-4402-9fc3-8405fd94107f 50436-0264 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000811 ANDA ANDA075665 Unit Dose Services ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-0274_bf821697-e560-4edf-b8ab-15673ad6579f 50436-0274 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Unit Dose Services FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-0284_0111d0f7-eb51-4f3d-a3bf-63e08a6b32f9 50436-0284 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Unit Dose Services AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50436-0291_5456e371-00d0-4689-bd69-be0942714410 50436-0291 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SYRUP ORAL 20130715 ANDA ANDA090102 Unit Dose Services RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50436-0296_5a343324-9546-4bae-96fd-0af00d1531e4 50436-0296 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120222 ANDA ANDA090796 Unit Dose Services IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-0299_8fc6797c-64d4-4344-8911-8f89f9130d8a 50436-0299 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Unit Dose Services ESZOPICLONE 1 mg/1 CIV N 20181231 50436-0300_8fc6797c-64d4-4344-8911-8f89f9130d8a 50436-0300 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Unit Dose Services ESZOPICLONE 2 mg/1 CIV N 20181231 50436-0301_8fc6797c-64d4-4344-8911-8f89f9130d8a 50436-0301 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Unit Dose Services ESZOPICLONE 3 mg/1 CIV N 20181231 50436-0302_2c7b54cd-e68b-408e-ad8c-cb946979a4d8 50436-0302 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA090678 Unit Dose Services RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 50436-0308_8658be4b-aa31-4eb7-b58d-8855aa218f3a 50436-0308 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Unit Dose Services NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20191231 50436-0320_171b21a8-23e9-46d4-a654-212168967e93 50436-0320 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 Unit Dose Services ESZOPICLONE 1 mg/1 CIV N 20181231 50436-0321_e2bc4b4b-c341-4045-b9f1-e93e7f24d044 50436-0321 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 Unit Dose Services IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-0322_171b21a8-23e9-46d4-a654-212168967e93 50436-0322 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 Unit Dose Services ESZOPICLONE 3 mg/1 CIV N 20181231 50436-0324_f1c44f48-8681-41b4-b7d4-ed95adf48249 50436-0324 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Unit Dose Services DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 50436-0331_b89686a0-da68-41b6-995c-272cc44a3540 50436-0331 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Unit Dose Services ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 50436-0333_45db3dec-7d7a-4992-a808-e85738c6e73d 50436-0333 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19841207 OTC MONOGRAPH FINAL part341 Unit Dose Services PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 N 20181231 50436-0340_f5984368-3775-4191-a1d3-b9ba23e532db 50436-0340 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19830202 ANDA ANDA062421 Unit Dose Services DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 50436-0352_698932ae-f417-4a67-b7e4-8140ec84267a 50436-0352 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Unit Dose Services LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-0376_87f12ef8-77a2-4849-b7eb-a837bfc3a6aa 50436-0376 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160602 ANDA ANDA202554 Unit Dose Services LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-0377_291234bd-9662-4501-8b02-73d042bbc9d0 50436-0377 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 Unit Dose Services TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50436-0387_088b8e35-794b-41fc-b793-e85c82328759 50436-0387 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Unit Dose Services DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-0396_d35beb8e-db2a-46e8-9b02-3445260f4f07 50436-0396 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Unit Dose Services OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-0399_dfbffe89-bad2-4518-a111-a67540b7425a 50436-0399 HUMAN OTC DRUG STOOL SOFTNER Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20160301 OTC MONOGRAPH NOT FINAL part334 Unit Dose Services DOCUSATE SODIUM 100 mg/1 N 20181231 50436-0412_cad7a5ce-4dc3-42a9-b189-fd9201205c92 50436-0412 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Unit Dose Services CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 50436-0423_ed3b7ad0-8bc6-4bc2-95b4-ed5aceab72f8 50436-0423 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL ELIXIR ORAL 20091101 UNAPPROVED DRUG OTHER Unit Dose Services PHENOBARBITAL; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; ATROPINE SULFATE 16.2; .1037; .0065; .0194 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 50436-0433_de7deea7-e574-4b93-ba10-65a446e7f2ff 50436-0433 HUMAN OTC DRUG dextromethorphan polistirex extended release dextromethorphan polistirex SUSPENSION ORAL 20120910 ANDA ANDA091135 Unit Dose Services DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 50436-0446_f8daa3ea-c4c2-4652-8d31-86b263233111 50436-0446 HUMAN PRESCRIPTION DRUG FINASTERIDE FINASTERIDE TABLET, FILM COATED ORAL 20110818 ANDA ANDA090507 Unit Dose Services FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 50436-0448_d42eb6ce-d25c-40df-b98f-72d9e916a577 50436-0448 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20100331 ANDA ANDA040445 Unit Dose Services METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 50436-0521_273b7ac7-4daf-4c7b-9b51-a151b4c2602a 50436-0521 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Unit Dose Services PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 50436-0528_dc3df43e-1baa-4ef4-a005-ba4d161184b3 50436-0528 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA200834 Unit Dose Services VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-0533_731fdb81-63d9-4aa9-a87e-e7123fdabbc1 50436-0533 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Unit Dose Services METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50436-0534_731fdb81-63d9-4aa9-a87e-e7123fdabbc1 50436-0534 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Unit Dose Services METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50436-0551_2397e723-aaee-4aa5-8a2e-a1fcf9606c16 50436-0551 HUMAN OTC DRUG Preferred Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER Unit Dose Services PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 50436-0555_1c6cf549-34d1-4d71-a034-98561abc0419 50436-0555 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Unit Dose Services RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 50436-0573_73bcef74-85cd-4842-9c93-f8cefb27113d 50436-0573 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040627 Unit Dose Services BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 50436-0576_0b46975c-65b5-4db7-827d-d9accc2dd0da 50436-0576 HUMAN PRESCRIPTION DRUG Metoclopramide metoclopramide hydrochloride SOLUTION ORAL 19910601 ANDA ANDA072744 Unit Dose Services METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 50436-0597_943b0832-a2ba-44b5-9c95-b97bdbc1105c 50436-0597 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20120515 ANDA ANDA202418 Unit Dose Services LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 50436-0619_0019dee9-0d88-4d70-89ab-c0980fb402e7 50436-0619 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, COATED ORAL 20140415 ANDA ANDA091024 Unit Dose Services ESZOPICLONE 2 mg/1 CIV N 20181231 50436-0676_9f5f695d-8a2f-4cbe-a15f-2d37d3d2c585 50436-0676 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021106 ANDA ANDA076201 Unit Dose Services DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-0682_6cef2a9e-e2ba-4cfe-9b65-d72fda13fb95 50436-0682 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 Unit Dose Services ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 50436-0684_97aeb9d2-7f81-4db3-b2d3-d238af2adac7 50436-0684 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Unit Dose Services IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 50436-0703_6440e641-138f-4d4d-88a1-ee83908185f8 50436-0703 HUMAN OTC DRUG Plus Pharma Pain Reliever,Fever Reducer ACETAMINOPHEN TABLET ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 Unit Dose Services ACETAMINOPHEN 325 mg/1 N 20181231 50436-0705_e3674d8a-6f2d-4012-9f49-2774d43496de 50436-0705 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20150601 ANDA ANDA205085 Unit Dose Services CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50436-0712_44fa8a21-2bde-4fe6-be85-b0696256af06 50436-0712 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE TABLET, DELAYED RELEASE ORAL 20140910 ANDA ANDA202882 Unit Dose Services PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 50436-0724_0e2db0e4-1bf4-4fbe-a8e2-ff06b378954d 50436-0724 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole TABLET, DELAYED RELEASE ORAL 20151001 ANDA ANDA204179 Unit Dose Services RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 50436-0736_41e03a34-a457-44c8-bd32-3b4b045ce60d 50436-0736 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Unit Dose Services NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-0737_62715127-8097-4344-bed0-d63518d2a935 50436-0737 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 Unit Dose Services HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 50436-0759_76969a41-c4ac-459b-ae71-debb016380be 50436-0759 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20050425 ANDA ANDA076913 Unit Dose Services PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-0775_7980ef69-c643-4d6a-b78e-84717693890f 50436-0775 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 Unit Dose Services LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 50436-0777_5a34150a-2253-4fbe-be4f-26e5002b54cb 50436-0777 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 Unit Dose Services ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50436-0787_277f2a3d-85c4-4d4b-bbb5-f3003d812b22 50436-0787 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 Unit Dose Services AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50436-0792_60be9ae1-1026-4c6b-a942-3f675341e9b6 50436-0792 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Unit Dose Services ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50436-0810_6e7cbe57-a125-442b-ae84-6f02bfa5e124 50436-0810 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Unit Dose Services NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-0813_89ec6ab3-4134-4a6d-89be-bcbd3913be1d 50436-0813 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Unit Dose Services GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-0821_b30450ac-db81-4f63-9b85-cd0078cc31af 50436-0821 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150701 NDA NDA022370 Unit Dose Services TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50436-0823_c3ffd953-4cd1-4c9d-b0d0-b4b5fffec802 50436-0823 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20120628 ANDA ANDA078783 Unit Dose Services TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50436-0824_29205219-3034-435c-a04a-f65586ff75b3 50436-0824 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111230 ANDA ANDA091607 Unit Dose Services TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50436-0830_3659ce4c-8aca-4680-81cc-3624ac4e1414 50436-0830 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 Unit Dose Services NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-0842_d611241c-fb45-4db9-8f51-17ac898793a6 50436-0842 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Unit Dose Services TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-0843_19101546-f25d-4a2e-875e-96771e736400 50436-0843 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Unit Dose Services TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-0846_3ba3933c-d2e8-4ab6-8490-4c933c8ba232 50436-0846 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 Unit Dose Services CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50436-0874_abe3c6cc-1c57-448d-83b9-42faf3efa58d 50436-0874 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 Unit Dose Services GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50436-0875_2c17dbf3-01fd-4ea6-9e7b-3169a43961f7 50436-0875 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 Unit Dose Services INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-0898_43f5def8-59be-45d2-835e-9c9dfad794c8 50436-0898 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM TOPICAL 19840710 NDA NDA018827 Unit Dose Services CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-0902_2b391cef-e0c3-48d4-8d53-a6bd95e841e7 50436-0902 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090225 NDA AUTHORIZED GENERIC NDA018553 Unit Dose Services PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-0903_b9188c9d-f023-480b-935e-81d15d86e3ba 50436-0903 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Unit Dose Services ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-0908_9e0d7c95-4bf8-4f9e-85bf-add84a9b5d55 50436-0908 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060403 ANDA ANDA076467 Unit Dose Services GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50436-0910_505e9885-1f3a-451c-a61c-e85026f80ce7 50436-0910 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Unit Dose Services NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-0913_63a0b555-09b1-4c7c-8704-7bf48643b84a 50436-0913 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970212 ANDA ANDA074869 Unit Dose Services CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-0915_5a27bd23-f391-435d-9a96-f8cab1bb80d9 50436-0915 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960917 ANDA ANDA074569 Unit Dose Services CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-0916_5d214e00-4bd2-465f-b710-7f393d760c28 50436-0916 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Unit Dose Services CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-0917_cf394877-82cb-4b0a-96bb-094d21885195 50436-0917 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 Unit Dose Services CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-0919_0a796822-44e7-46a5-94ca-f9a372ac29bb 50436-0919 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Unit Dose Services BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 50436-0922_b3b917f6-b8c9-4b9a-a6fd-6bd4926b7732 50436-0922 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Unit Dose Services FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-0923_7675fb6d-3904-4b34-8039-5bda7632d156 50436-0923 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Unit Dose Services FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-0924_38649f64-ac80-4d02-9cfe-fb2f86ee0992 50436-0924 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Unit Dose Services FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-0933_7867908c-c0e2-4d1b-b178-0be2a3014a40 50436-0933 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20120312 ANDA ANDA040911 Unit Dose Services LIDOCAINE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 50436-0934_711fcd8b-4c89-421e-bd7c-e40ec1989112 50436-0934 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50436-0950_7175311c-a773-40ac-80df-cc71fed6f2a2 50436-0950 HUMAN PRESCRIPTION DRUG Fexmid Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20111001 ANDA ANDA071611 Unit Dose Services CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50436-0994_5bd37e03-b64f-486b-98a0-884f48bf0377 50436-0994 HUMAN OTC DRUG Meclizine HCl 25 mg Meclizine Hydrochloride TABLET, CHEWABLE ORAL 20151015 OTC MONOGRAPH FINAL part336 Unit Dose Services MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 50436-1000_5d747b2d-0ff7-41f5-933f-2b374b0f581a 50436-1000 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 Unit Dose Services FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50436-1001_b5b70109-7b3d-4832-9ca8-48fbf1b9684f 50436-1001 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021121 ANDA ANDA065093 Unit Dose Services AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 50436-1006_e85ee5db-46e6-4b44-a456-3fcb5b8bc0fd 50436-1006 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077239 Unit Dose Services ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 50436-1010_e965a8f3-5d07-4e39-a960-ca936504a80a 50436-1010 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20031107 ANDA ANDA065085 Unit Dose Services MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 50436-1020_68c17d23-60f2-4b50-85a0-c7e9d6ab6ec2 50436-1020 HUMAN PRESCRIPTION DRUG Cephalexin cephalexin CAPSULE ORAL 20150602 ANDA ANDA062713 Unit Dose Services CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50436-1022_8c2c000b-7df9-45d2-9fb8-a375610ea5b9 50436-1022 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Unit Dose Services DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-1029_a5ea91e6-6323-46bf-abf2-260d887ce56c 50436-1029 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SOLUTION ORAL 20060131 ANDA ANDA040650 Unit Dose Services PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 50436-1070_489f031d-6996-404f-bdb6-07783fd61ea2 50436-1070 HUMAN PRESCRIPTION DRUG Rabeprazole sodium Rabeprazole sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA202376 Unit Dose Services RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 50436-1074_17fd7416-2452-4465-9768-61609bbd94fe 50436-1074 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Unit Dose Services FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 50436-1182_ef2f8367-f02a-4c60-b5d0-f3c64b3900b3 50436-1182 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19950928 ANDA ANDA074376 Unit Dose Services DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-1220_77ea7abc-e3c9-4104-b9dc-18aa5275aeda 50436-1220 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Unit Dose Services TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-1221_4d47995a-79e1-4a57-9119-766baa5d6d22 50436-1221 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 Unit Dose Services DOCUSATE SODIUM 100 mg/1 N 20181231 50436-1222_b947c887-4900-452b-bff2-d2044f9d403d 50436-1222 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 Unit Dose Services DOCUSATE SODIUM 100 mg/1 N 20181231 50436-1223_1d4c47c9-f1c3-451a-8847-c6783fe7ad7f 50436-1223 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Unit Dose Services DOCUSATE SODIUM 100 mg/1 N 20181231 50436-1262_02926bb2-e906-467c-aae1-4dedaab2b7c3 50436-1262 HUMAN PRESCRIPTION DRUG Gralise gabapentin TABLET, FILM COATED ORAL 20110128 NDA NDA022544 Unit Dose Services GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-1263_b59d3f10-38d8-4708-82ef-fe9135f2e458 50436-1263 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Unit Dose Services GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-1265_d25545fa-12a6-48d8-bd62-67c162316019 50436-1265 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Unit Dose Services PREGABALIN 50 mg/1 N 20181231 50436-1310_18723264-f933-49a2-ae5e-cfb576ec15bb 50436-1310 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 Unit Dose Services PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-1331_d61820f8-f0bb-4fa8-bd50-719070081acc 50436-1331 HUMAN PRESCRIPTION DRUG LIDODERM lidocaine PATCH CUTANEOUS 19990320 NDA NDA020612 Unit Dose Services LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 50436-1332_0498faaf-5cd8-4aed-a750-444f16abf35f 50436-1332 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20080114 NDA NDA021234 Unit Dose Services DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-1334_b78a4ba1-c7ec-429a-af84-611da47ad132 50436-1334 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine GEL TOPICAL 20130301 UNAPPROVED DRUG OTHER Unit Dose Services LIDOCAINE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 50436-1425_7eba52aa-ba39-4ca1-8edf-41b4b73bb0bb 50436-1425 HUMAN PRESCRIPTION DRUG Nystatin nystatin OINTMENT TOPICAL 19820923 ANDA ANDA062124 Unit Dose Services NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 50436-1496_c9c07e01-3d5c-4535-8b04-f386b8ca65a3 50436-1496 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Unit Dose Services AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50436-1695_d4345c7e-cad9-4686-a4ff-e5cae6bcd6b0 50436-1695 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20120913 ANDA ANDA200243 Unit Dose Services BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 50436-1720_181da524-97ce-4ada-adf0-c1682d822ba1 50436-1720 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Unit Dose Services PREDNISONE 5 mg/1 N 20181231 50436-1750_181da524-97ce-4ada-adf0-c1682d822ba1 50436-1750 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Unit Dose Services PREDNISONE 20 mg/1 N 20181231 50436-1827_3c37691d-5bdf-4208-a30a-8b4ba17e765f 50436-1827 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION OROPHARYNGEAL 20070227 ANDA ANDA040708 Unit Dose Services LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 50436-1867_14f7c995-e018-4cc6-8b48-d160aa2c9047 50436-1867 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SOLUTION ORAL 20060214 ANDA ANDA040649 Unit Dose Services DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 50436-1873_623fb153-dde3-46f2-a170-2aed4163c83c 50436-1873 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19930701 ANDA ANDA072801 Unit Dose Services METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 50436-2000_aa45b0b5-cf0c-4b0e-bccc-bed7081a0e31 50436-2000 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 Unit Dose Services LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-2002_eaf0e72d-d713-4f40-a19c-d67f043dae73 50436-2002 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20100601 ANDA ANDA077789 Unit Dose Services CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 50436-2143_01d045b8-1007-43cf-88cc-7b137828faf6 50436-2143 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19861216 ANDA ANDA089414 Unit Dose Services HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-2144_d1c3ba72-408f-4ef3-bd2d-c601dbedcfbd 50436-2144 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20050428 ANDA ANDA088799 Unit Dose Services HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-2171_c224e7fb-44e1-4631-9f12-545c27368eab 50436-2171 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141118 ANDA ANDA040148 Unit Dose Services HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50436-2210_9be4b3c9-0881-4a4b-9199-9d0307837b46 50436-2210 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 Unit Dose Services CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50436-2212_798a9231-5e90-4caa-aa82-c4fe87240d05 50436-2212 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-2472_572d3e3d-4af3-4982-b57e-3beddca893f3 50436-2472 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20101104 ANDA ANDA077839 Unit Dose Services ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 50436-2582_48872b8b-a0c5-4330-ba0c-24d545c83aac 50436-2582 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Unit Dose Services CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 50436-2605_c224e7fb-44e1-4631-9f12-545c27368eab 50436-2605 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130314 ANDA ANDA040148 Unit Dose Services HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50436-2607_c00f0b75-f25c-426d-b7f4-502b4b46dddd 50436-2607 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Unit Dose Services CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 50436-2608_b8de2345-a8fc-4191-a109-d01dd0742794 50436-2608 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Unit Dose Services CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 50436-2609_6cc12ca2-8c09-411d-b3b5-335c7df145da 50436-2609 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Unit Dose Services CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 50436-2612_c224e7fb-44e1-4631-9f12-545c27368eab 50436-2612 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130307 ANDA ANDA040148 Unit Dose Services HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50436-2640_015b035a-00e5-45d0-9b3b-9de18a3be561 50436-2640 HUMAN PRESCRIPTION DRUG Fluticasone Fluticasone Propionate SPRAY, METERED NASAL 20120109 ANDA ANDA078492 Unit Dose Services FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-2703_5311688b-a04d-482a-b12f-b2dda2535489 50436-2703 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-2892_4d2a8baf-f63d-466f-aac1-4df63c965245 50436-2892 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20131217 ANDA ANDA090776 Unit Dose Services DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-2899_04491d11-f854-4302-b297-1ff55ea22268 50436-2899 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20030512 ANDA ANDA075849 Unit Dose Services OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-2948_73f867a1-3da9-4c6f-8f57-d337d237af2c 50436-2948 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Unit Dose Services CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-2982_116ad40d-1ca3-4621-b370-fd639b079990 50436-2982 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131127 ANDA ANDA201447 Unit Dose Services OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 50436-2983_116ad40d-1ca3-4621-b370-fd639b079990 50436-2983 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131127 ANDA ANDA201447 Unit Dose Services OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 50436-2995_597ce431-4b0c-44cc-9483-70eff4423961 50436-2995 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Unit Dose Services DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-2996_597ce431-4b0c-44cc-9483-70eff4423961 50436-2996 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Unit Dose Services DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-2997_597ce431-4b0c-44cc-9483-70eff4423961 50436-2997 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Unit Dose Services DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-3000_0f229ba8-b967-4f58-9a6f-b951872536b7 50436-3000 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Unit Dose Services LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-3011_b1dd907e-9af0-450c-8a83-8068b6ce7dc2 50436-3011 HUMAN PRESCRIPTION DRUG gabapentin gabapentin TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Unit Dose Services GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-3024_d65020d4-51d5-4562-967d-fab060cb1b9b 50436-3024 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 Unit Dose Services METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 50436-3026_1a416e51-612f-43a2-ac6f-c84c8a4ae537 50436-3026 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Unit Dose Services ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 50436-3027_31f1f83b-d11b-445f-9250-ae3ec38ae5c8 50436-3027 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20091001 ANDA ANDA071586 Unit Dose Services ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 50436-3028_8c636850-8c42-4726-ad4a-da47151cca35 50436-3028 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Unit Dose Services ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 50436-3030_efa32477-9a65-4f9f-bc2d-02c059bb8a4c 50436-3030 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Unit Dose Services ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 50436-3031_e62c15ca-46f0-4750-b155-f1b8014dc849 50436-3031 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Unit Dose Services ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 50436-3071_b99aa89e-3148-4b0e-8116-b97f3b39f274 50436-3071 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-3072_89eb0844-d69a-4e2d-992c-090e310b7474 50436-3072 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-3073_32fefe57-a9f6-44ae-8ea5-b1fdc2b60992 50436-3073 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-3074_4f601f35-3045-4406-b0ed-17d1fad4dab4 50436-3074 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085967 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-3075_7e6ce3a5-fef4-4126-afc0-c029b15564fd 50436-3075 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Unit Dose Services AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-3098_9c938a00-3ee9-4729-84c8-97e2194064a5 50436-3098 HUMAN PRESCRIPTION DRUG Silver Sulfadiazene Silver Sulfadiazine CREAM TOPICAL 19820225 NDA NDA018578 Unit Dose Services SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 50436-3099_8f71d414-5762-44b5-8cd1-02af10abb95a 50436-3099 HUMAN PRESCRIPTION DRUG Silver Sulfadiazene Silver Sulfadiazine CREAM TOPICAL 19820225 NDA NDA018578 Unit Dose Services SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 50436-3101_ec5d2e6d-59e3-4769-8708-3efae672cb3d 50436-3101 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19950703 ANDA ANDA074076 Unit Dose Services LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 50436-3120_50e2c3d5-7948-43bf-8995-5ea53105ef93 50436-3120 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20150217 ANDA ANDA078003 Unit Dose Services ESOMEPRAZOLE MAGNESIUM DIHYDRATE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-3121_5e637840-e5e7-4b81-8837-5d2fde2be7f8 50436-3121 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 Unit Dose Services ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-3125_04c1739e-c969-4866-90a1-ee7284cb5ef6 50436-3125 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 Unit Dose Services OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-3126_6aa8ec24-1ae8-458a-902b-63843c322ea6 50436-3126 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Unit Dose Services OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-3127_fff53f05-b9b1-49e3-874f-df2dca0e19a7 50436-3127 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Unit Dose Services OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-3129_66e466b2-fce8-4158-8d30-ab6ebeb951ee 50436-3129 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 Unit Dose Services AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 50436-3135_cad7a5ce-4dc3-42a9-b189-fd9201205c92 50436-3135 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Unit Dose Services CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 50436-3136_fd611572-856d-4d95-8c5b-2b2bf2ed1317 50436-3136 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150818 ANDA ANDA065399 Unit Dose Services AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50436-3138_40901a58-57b6-44fe-8f24-7f2b52455724 50436-3138 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Unit Dose Services FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-3140_3d3d2f01-4c85-49a9-a3e8-32528f0a9c4e 50436-3140 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Unit Dose Services BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50436-3145_2525a0b7-7131-48a6-9691-f37019e7bbfd 50436-3145 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Unit Dose Services BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50436-3146_5ad48c1d-1c87-48d5-9da7-4426fcae1e40 50436-3146 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Unit Dose Services BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50436-3148_6b9c7d29-ea99-4100-b03b-918d372885de 50436-3148 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Unit Dose Services CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 50436-3155_a8d7b233-9e82-4be0-815e-52ecd61abc32 50436-3155 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090324 ANDA ANDA078459 Unit Dose Services METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-3171_e25df306-ad2a-4af5-a8d9-6ce35cba9304 50436-3171 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Unit Dose Services HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 50436-3172_917481f1-e5f4-46a0-b956-b96ec5336256 50436-3172 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20130412 ANDA ANDA091667 Unit Dose Services MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 50436-3173_29d60b3e-3e48-410c-8b91-5a5fa2ecdcb4 50436-3173 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 Unit Dose Services PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-3174_c4ad2282-304c-4199-b27b-ce00fbd8c6ce 50436-3174 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20031023 ANDA ANDA040525 Unit Dose Services PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-3175_bfe9528c-b63a-4ba2-812c-2dbd4d53e1a3 50436-3175 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Unit Dose Services PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-3176_18723264-f933-49a2-ae5e-cfb576ec15bb 50436-3176 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 Unit Dose Services PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-3182_116ac935-7862-471c-9cc3-35d07cd472da 50436-3182 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Unit Dose Services OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 50436-3220_b09e920c-deb1-4be9-8f7a-9e20764a3921 50436-3220 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20110421 OTC MONOGRAPH NOT FINAL part343 Unit Dose Services ACETAMINOPHEN 325 mg/1 N 20181231 50436-3227_850264fa-bc78-43d1-85da-187a3cbac55b 50436-3227 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 Unit Dose Services ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 50436-3330_e256b188-290a-4a7c-a4ca-8278699a46b8 50436-3330 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Unit Dose Services ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-3331_7cc04f91-7f71-4df6-b73d-092bf765dcee 50436-3331 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Unit Dose Services ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-3332_ef619d26-10cf-47a4-8eb9-16fa991acdfb 50436-3332 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100610 ANDA ANDA077443 Unit Dose Services ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-3367_ee79dc05-95bb-465d-bc6b-1923fa414574 50436-3367 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 Unit Dose Services DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 50436-3415_0069f75e-9a4a-4051-a519-b7e731a8b92f 50436-3415 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 Unit Dose Services CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 50436-3435_de5fbc65-b5ae-4717-ab51-eabcc2ddad76 50436-3435 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 Unit Dose Services CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 50436-3444_79069abb-74da-4b2c-b6d4-27ddd8dced65 50436-3444 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 Unit Dose Services CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50436-3501_cba498ce-6f23-44b4-82e4-dc1c7074369d 50436-3501 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Unit Dose Services LORATADINE 10 mg/1 N 20181231 50436-3502_08c4eeec-7df1-4ac1-8557-46eb0118a02d 50436-3502 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Unit Dose Services LORATADINE 10 mg/1 N 20181231 50436-3523_cdb1087f-c366-42cf-aee4-a9a260057b4f 50436-3523 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070974 Unit Dose Services CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50436-3524_9720cd33-6862-451e-a590-d3ed7a8bdcee 50436-3524 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Unit Dose Services CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50436-3526_a3bfc5ec-cc12-49f1-8ed1-30fa92b05422 50436-3526 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070923 Unit Dose Services CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50436-3592_a8b57ca8-723d-4637-b004-08802486356b 50436-3592 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071321 Unit Dose Services DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-3593_dd6b33ce-17c8-45f6-90c7-35bbc2a6dfb3 50436-3593 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 20190831 ANDA ANDA077749 Unit Dose Services DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-3594_6a955499-253f-4acf-bae5-8bdddbee0662 50436-3594 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Unit Dose Services DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50436-3613_8cfb08cd-4a16-4f77-839e-ca176bbfb6e5 50436-3613 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062936 Unit Dose Services PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50436-3621_45470c3b-f437-4380-a9a4-85a16a30ee18 50436-3621 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20071017 NDA NDA022122 Unit Dose Services DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-3622_376f2ced-6874-4b62-aa44-c04ea9524a48 50436-3622 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20100723 ANDA ANDA091004 Unit Dose Services ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 50436-3718_f5b30aac-692e-4302-be23-c4987468182c 50436-3718 HUMAN PRESCRIPTION DRUG Triazolam triazolam TABLET ORAL 19821115 NDA AUTHORIZED GENERIC NDA017892 Unit Dose Services TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-3762_084d9c08-d54c-4539-9a62-efe20624547d 50436-3762 HUMAN OTC DRUG Banophen diphenhydramine hcl CAPSULE ORAL 20091102 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 50436-3763_f462b10a-d193-41d4-8d1a-bf724cb9c319 50436-3763 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20130227 NDA AUTHORIZED GENERIC NDA012462 Unit Dose Services DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 50436-3779_9fe00c5c-dc3a-428f-b648-1031e5cb2828 50436-3779 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 NDA AUTHORIZED GENERIC NDA020699 Unit Dose Services VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-3800_e6bd46d6-fe7d-44c2-81d0-4744cc6a0f0e 50436-3800 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Unit Dose Services PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-3840_4a4962a2-fddf-452a-a541-de89b6039b6a 50436-3840 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Unit Dose Services FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50436-3841_6c397fb1-dc0b-4e70-a377-a2062ef651c9 50436-3841 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Unit Dose Services FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50436-3845_b4b93a91-4b55-4572-8149-2906934821c1 50436-3845 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 Unit Dose Services FOLIC ACID 1 mg/1 N 20181231 50436-3849_d165d1f4-c436-4f7c-a706-5fdd5a4a02a6 50436-3849 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 Unit Dose Services CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-3874_4d9d861f-f48e-4c59-b6e8-22756387fb5d 50436-3874 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Unit Dose Services HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 50436-3897_fdf14401-b3e3-4f14-a7da-351d7898be6e 50436-3897 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Unit Dose Services MIRTAZAPINE 15 mg/1 N 20181231 50436-3913_116ad40d-1ca3-4621-b370-fd639b079990 50436-3913 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131210 ANDA ANDA201447 Unit Dose Services OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 50436-3918_5b96a445-e22d-43f7-a3b0-a11cda29e3e2 50436-3918 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Unit Dose Services HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50436-3919_2ac42df2-d4f7-4a88-a0b1-a2e3ff1f428c 50436-3919 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 Unit Dose Services HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50436-3922_e3d78a24-d4e9-4790-b2be-82cd74c5bca0 50436-3922 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070501 ANDA ANDA084325 Unit Dose Services HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50436-3933_3c32f960-ac0d-461c-9d73-2110b36291b9 50436-3933 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Unit Dose Services PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-3944_07387db8-293b-4ae4-8625-c8e89360a293 50436-3944 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Unit Dose Services ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50436-3945_16c1472e-5bba-4f37-ac56-3dbba8b5c68a 50436-3945 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100607 ANDA ANDA075522 Unit Dose Services ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50436-3953_f30a6044-f4d1-46ec-826c-bcbc5f3de3fb 50436-3953 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 50436-3954_c65fa8af-2972-47bb-87a1-efd5c3911134 50436-3954 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 50436-3960_2faac410-f6c5-485b-837a-f7f98c9e50fc 50436-3960 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 Unit Dose Services LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-3974_ab0b3856-ca6c-4e62-9c16-63c04b8e1bd8 50436-3974 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 19910918 ANDA ANDA072741 Unit Dose Services LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 50436-3983_86d24602-62de-49ce-914f-9ea8defe0bc8 50436-3983 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150312 ANDA ANDA200562 Unit Dose Services CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-3984_86d24602-62de-49ce-914f-9ea8defe0bc8 50436-3984 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150312 ANDA ANDA200562 Unit Dose Services CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-3986_bde4458c-5c7a-493e-bc32-5a37b08de19d 50436-3986 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 20100604 ANDA ANDA040659 Unit Dose Services MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 50436-3988_2e9294f8-ef0b-40e2-a73c-13489d63fcd8 50436-3988 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 Unit Dose Services MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 50436-3989_bc04325e-2eb5-4f0f-ba02-8ec2a46cdd6b 50436-3989 HUMAN OTC DRUG TRAVEL SICKNESS MECLIZINE HCL Meclizine HCl TABLET, CHEWABLE ORAL 20140819 OTC MONOGRAPH FINAL part336 Unit Dose Services MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 50436-3995_0720797a-7f77-4eae-be44-1bcc5e333d24 50436-3995 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Unit Dose Services LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50436-3996_c602621b-13e0-44e4-a644-3b8ee9fb92ed 50436-3996 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Unit Dose Services LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50436-3998_229f0f2a-9bbe-481f-88f0-ad178f7f5704 50436-3998 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 Unit Dose Services ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50436-4000_a36c3511-0056-41e7-b6de-2950f9c1d86f 50436-4000 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 Unit Dose Services LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-4026_5d8c9708-c98d-4045-868a-ba6cf61ba872 50436-4026 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Unit Dose Services METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50436-4027_2675e5aa-def7-46de-bca9-ed997a321f60 50436-4027 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Unit Dose Services METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50436-4032_4e52cf0f-97af-4db4-ac3a-8fb33cf8b3c1 50436-4032 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070035 Unit Dose Services METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 50436-4033_a4f6fca2-035d-4406-bd2d-7e5bd67a75bc 50436-4033 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070044 Unit Dose Services METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 50436-4034_5b9fd3c0-d4da-4d35-a3bd-8d01cad614bb 50436-4034 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Unit Dose Services HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 50436-4037_a640ff30-da86-4523-9848-3499265ab745 50436-4037 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 Unit Dose Services METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-4068_1ff669f1-8947-4022-8c55-a889b8a6c7e9 50436-4068 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Unit Dose Services NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50436-4069_3f490c79-a773-46be-ae11-6ecbcac231ae 50436-4069 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Unit Dose Services NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50436-4097_463d6e98-1821-4276-9778-223890c75873 50436-4097 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072235 Unit Dose Services BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 50436-4164_70fac393-0c33-43da-a152-61dfd38ae346 50436-4164 HUMAN PRESCRIPTION DRUG DIETHYLPROPION HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TABLET ORAL 20101227 ANDA ANDA201212 Unit Dose Services DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-4233_bb0347ee-0c45-49cf-9ee8-4a7cc81cfbf8 50436-4233 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Unit Dose Services BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50436-4234_7f8cf9a1-4345-4d71-9223-a0ce3456ec07 50436-4234 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Unit Dose Services BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 50436-4247_4c3698d1-517f-41ec-b617-8de8db8f5751 50436-4247 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 19980330 ANDA ANDA074823 Unit Dose Services TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50436-4311_42a2b0b6-9781-4001-a9a1-0f806fe3c9d6 50436-4311 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 Unit Dose Services POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 50436-4313_c9c3ac59-f1d5-4f0c-9f84-f34b1fecf258 50436-4313 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Unit Dose Services PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-4314_90e51e66-005f-472b-b003-4df2c9ed3755 50436-4314 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Unit Dose Services PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-4315_d266a2f3-a7bb-4837-9ec2-d4be17f4373d 50436-4315 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Unit Dose Services PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-4324_2ab26951-c3f2-44a5-903a-1ad2b9dded0d 50436-4324 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 Unit Dose Services PREDNISONE 5 mg/1 N 20181231 50436-4325_2b6c52d4-8fbc-4b9c-ab10-48d9291eb5f2 50436-4325 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19851204 ANDA ANDA088832 Unit Dose Services PREDNISONE 10 mg/1 N 20181231 50436-4326_81d67588-8000-4cc0-8a53-2960fd1fd224 50436-4326 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 Unit Dose Services PREDNISONE 20 mg/1 N 20181231 50436-4335_cabf48bf-5b14-4c99-8424-6ff784650af7 50436-4335 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 19970214 ANDA ANDA064120 Unit Dose Services POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 50436-4352_c78e0dd0-0412-4387-b19a-277f987dc9e7 50436-4352 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50436-4353_b2536193-1c24-4156-b6ec-c45e66359d9c 50436-4353 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50436-4356_dfcaa7bd-7b27-419a-96ad-9acb93c31834 50436-4356 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Unit Dose Services AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50436-4357_a6aa72f4-f6df-40e9-a446-f2801ac785c9 50436-4357 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065153 Unit Dose Services AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 50436-4364_53a68870-5146-42eb-9925-7e748bf7afa3 50436-4364 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Unit Dose Services LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-4365_fda9d15a-984f-463e-bfaa-ab0a25047342 50436-4365 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA074787 Unit Dose Services LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-4379_4008c6a9-f18b-4d8e-8af6-592be18d910d 50436-4379 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET ORAL 20060731 ANDA ANDA040712 Unit Dose Services PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 50436-4380_49ef1618-abc2-48b5-8d61-af91cb1b9169 50436-4380 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 50436-4387_66b05fad-7017-46fe-8d38-b7c95bc1e5bb 50436-4387 HUMAN OTC DRUG Preferred Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20150115 UNAPPROVED DRUG OTHER Unit Dose Services PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 50436-4388_b376ff39-4351-46a0-8dca-31a25dba3a81 50436-4388 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Unit Dose Services PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 50436-4448_9f9812a3-78f1-45ec-97b8-f1648d1bc4fb 50436-4448 HUMAN PRESCRIPTION DRUG ketoconazole ketoconazole CREAM TOPICAL 20040428 ANDA ANDA076294 Unit Dose Services KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50436-4477_2a42310c-b64a-401f-8c5a-391127ee710c 50436-4477 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 Unit Dose Services SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 50436-4500_932e320c-7728-445e-a181-09b6e3afe78f 50436-4500 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Unit Dose Services DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-4501_c870aa61-af8b-40af-9b2d-578175165c18 50436-4501 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Unit Dose Services DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-4543_1a19a61a-5a82-450f-b76d-4025ef92bb60 50436-4543 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 Unit Dose Services AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50436-4546_b8656e41-ef9e-4571-8da3-6bcf44b965f9 50436-4546 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20010605 ANDA ANDA075502 Unit Dose Services CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-4565_f81af2c6-92c6-461e-b562-f3dab3331ded 50436-4565 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Unit Dose Services DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-4600_33d9d737-7a48-4a25-9fe5-6387897b43b3 50436-4600 HUMAN PRESCRIPTION DRUG Acetic Acid Acetic Acid SOLUTION AURICULAR (OTIC) 19960726 ANDA ANDA040166 Unit Dose Services ACETIC ACID 20 mg/mL N 20181231 50436-4604_97aeb9d2-7f81-4db3-b2d3-d238af2adac7 50436-4604 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Unit Dose Services IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 50436-4605_3084b568-a1f8-461b-97ad-00be615eac2e 50436-4605 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Unit Dose Services IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-4606_e751abdb-c833-49a1-b3a6-7d481af0757f 50436-4606 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Unit Dose Services IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-4622_7f099ecb-33ab-4bf7-955f-cbbeb8614d8b 50436-4622 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20090813 ANDA ANDA076554 Unit Dose Services SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 50436-4623_1e6a54ec-5b23-40e2-879e-db839374bc7a 50436-4623 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20090813 ANDA ANDA076554 Unit Dose Services SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 50436-4624_016bafb1-591f-40ee-a1e5-72e698051eac 50436-4624 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Unit Dose Services SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 50436-4628_dfd073ae-757d-4868-aa76-a76b36723b0b 50436-4628 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19900930 ANDA ANDA071620 Unit Dose Services TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-4629_2fa92384-13e6-44a3-ae56-188355987b23 50436-4629 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19900930 ANDA ANDA071620 Unit Dose Services TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-4630_bbc37c80-5793-43c1-bd19-2487dc61fbc8 50436-4630 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120628 ANDA ANDA071457 Unit Dose Services TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-4633_c3f06148-8939-4eae-90fb-238c8bd66e62 50436-4633 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931001 ANDA ANDA074342 Unit Dose Services ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-4634_6eb58cf9-2a81-4972-8c69-d9656929eedf 50436-4634 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Unit Dose Services ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-4635_c62a7198-b3f4-4a5f-b6d5-f92d2f75f714 50436-4635 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Unit Dose Services ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-4636_57e09bd8-0f86-4894-b62a-ec2475aa9db8 50436-4636 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Unit Dose Services ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-4652_2588bc36-25ce-4e79-ab41-2ae9f24f5b1d 50436-4652 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202254 Unit Dose Services IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50436-4653_51d88509-cbeb-4bfb-895a-84781ae344b7 50436-4653 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50436-4688_0df8e8b9-8a34-4f2a-b7fd-caa129ce84d5 50436-4688 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 Unit Dose Services TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 50436-4693_bfe65adc-442b-4121-9acd-e48fb25a8060 50436-4693 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Unit Dose Services SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 50436-4694_4ef53df1-92ba-4d99-a3b6-fcaefd863238 50436-4694 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Unit Dose Services SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 50436-4715_5d539266-6da4-4583-9208-4cc4fa7b1dab 50436-4715 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Unit Dose Services TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 50436-4777_ddfe8060-bf75-44e2-80aa-39ea9d42705e 50436-4777 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 19900930 ANDA ANDA071655 Unit Dose Services OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 50436-4842_32dbc9c9-fb8d-48d0-80ac-11eed02a0507 50436-4842 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 20181031 ANDA ANDA077797 Unit Dose Services CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50436-4856_12f33220-6250-4b56-8758-94d2c51fbd11 50436-4856 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 19870121 ANDA ANDA089175 Unit Dose Services BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 50436-5000_d2e876c3-3e89-4260-956a-388237ad09fd 50436-5000 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 Unit Dose Services LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-5015_be118d7d-fa6c-44e5-9420-9a824d59ac22 50436-5015 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 Unit Dose Services SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 50436-5022_620547c6-4c2e-441b-b7fc-c95e0c409091 50436-5022 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Unit Dose Services CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50436-5050_66eb2b5f-0210-4c45-a14a-25cc89396fe2 50436-5050 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110301 ANDA ANDA075693 Unit Dose Services IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 50436-5101_163b6898-4fdb-4fbb-9652-78e3580555e3 50436-5101 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Unit Dose Services AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50436-5128_cdf30efe-780c-4989-a99f-25d0a0f3fdd9 50436-5128 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 19900129 NDA AUTHORIZED GENERIC NDA019949 Unit Dose Services FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 50436-5129_d134dfcd-14ab-4b0d-b46d-40e5cb323d22 50436-5129 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140620 ANDA ANDA076658 Unit Dose Services FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 50436-5130_2d4eaeee-b9b6-4943-a8fe-b5c02b96e06d 50436-5130 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 Unit Dose Services CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50436-5165_3263a6cb-005d-4fce-97d8-e6345f0924be 50436-5165 HUMAN OTC DRUG Plus Pharma Senna Standardized Senna Concentrate 8.6 mg Sennosides Each SENNOSIDES TABLET, FILM COATED ORAL 20060327 OTC MONOGRAPH NOT FINAL part334 Unit Dose Services SENNOSIDES 8.6 mg/1 N 20181231 50436-5166_511abdb0-d6aa-488d-a421-857afa9498d7 50436-5166 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20040923 ANDA ANDA065162 Unit Dose Services AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 50436-5500_0ab3c14a-f79d-44fa-926d-666148c79ff9 50436-5500 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 50436-5501_16626b29-36c7-4fd9-949e-65cbcef62728 50436-5501 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 50436-5503_27293535-56c6-42dd-baa4-08e8e8ead721 50436-5503 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 50436-5504_0bbb0057-7483-4fce-9ed6-40c95092b51a 50436-5504 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 50436-5505_4c8799c6-08f4-465c-96d7-6b25363118e7 50436-5505 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 50436-5506_0873d315-b290-4b67-b3d2-95541094d19d 50436-5506 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 50436-5537_72a8b737-aedc-4983-9fd9-b3dcf9320b85 50436-5537 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Unit Dose Services ESZOPICLONE 1 mg/1 CIV N 20181231 50436-5538_217153c5-d085-43a3-92a8-5b2cbda2dbd6 50436-5538 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140414 ANDA ANDA091169 Unit Dose Services ESZOPICLONE 2 mg/1 CIV N 20181231 50436-5539_217153c5-d085-43a3-92a8-5b2cbda2dbd6 50436-5539 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140414 ANDA ANDA091169 Unit Dose Services ESZOPICLONE 3 mg/1 CIV N 20181231 50436-5550_cb44ee11-74ba-4e5d-aa5b-3858fd48110a 50436-5550 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 Unit Dose Services GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-5559_f788ef5d-2cc8-4990-9369-2447297253b4 50436-5559 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20100105 ANDA ANDA074118 Unit Dose Services PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-5604_25efaebc-f5ca-4cb3-8b6f-a30467d20648 50436-5604 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Unit Dose Services LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-5605_32204496-6dce-422d-8550-0f225af40a68 50436-5605 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Unit Dose Services LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-5606_84493ff4-6df1-4599-a1ef-b8890128e23b 50436-5606 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Unit Dose Services LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-5620_3a2bf7d1-fb41-4c93-acbd-cdecf853ffd7 50436-5620 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071136 Unit Dose Services DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-5851_d36705e1-174c-4b9c-8d0b-ec6a8c698390 50436-5851 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Unit Dose Services ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-5861_9ee021c2-8348-4910-8b6a-10cda83194ca 50436-5861 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20141215 ANDA ANDA090022 Unit Dose Services ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 50436-5862_4344f027-ee56-46c3-aa02-a71f89121b7d 50436-5862 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Unit Dose Services ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 50436-5890_c15f644b-745d-43fe-9b6e-a14968da24d7 50436-5890 HUMAN OTC DRUG FERROUS SULFATE IRON SUPPLEMENT TABLET ORAL 20010219 UNAPPROVED DRUG OTHER Unit Dose Services FERROUS SULFATE 325 mg/1 N 20181231 50436-5891_957f89f7-5aad-42ba-acf4-35e1359b6a5e 50436-5891 HUMAN OTC DRUG FERROUS SULFATE IRON SUPPLEMENT TABLET ORAL 20010219 UNAPPROVED DRUG OTHER Unit Dose Services FERROUS SULFATE 325 mg/1 N 20181231 50436-5995_27f420ea-8046-458b-af75-d9869b80e987 50436-5995 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Unit Dose Services BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 50436-5996_dc6172ff-43c6-4d41-8395-8ff9a0fc642d 50436-5996 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Unit Dose Services BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 50436-6041_0a1819ad-cf70-405a-b3d0-263bc344996d 50436-6041 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 Unit Dose Services CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50436-6046_0daa6ea0-5367-4ad4-bfff-ddf3afc5830c 50436-6046 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Unit Dose Services NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-6050_aa58d675-a818-482e-88be-f2f7236e09ba 50436-6050 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 Unit Dose Services ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 50436-6051_c600f834-3429-4be4-9514-5be109748043 50436-6051 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 Unit Dose Services AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 50436-6052_b5b70109-7b3d-4832-9ca8-48fbf1b9684f 50436-6052 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021127 ANDA ANDA065117 Unit Dose Services AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 50436-6103_597b4162-9e37-45a3-b65a-6e2f73d915d9 50436-6103 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Unit Dose Services CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-6104_535f31b7-c266-4008-ada2-39f06983558d 50436-6104 HUMAN PRESCRIPTION DRUG CAPTOPRIL captopril TABLET ORAL 19970328 ANDA ANDA074532 Unit Dose Services CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-6106_c5e4aa3c-5d75-4e38-91f6-8def2e769aab 50436-6106 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Unit Dose Services CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-6112_701c61c5-5588-410d-a69e-c492e35321dd 50436-6112 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076622 Unit Dose Services OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 50436-6124_4d827f4c-eafa-4285-83b1-0c216cb34575 50436-6124 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Unit Dose Services DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 50436-6126_2c551417-a2d1-487c-8a24-dbbba526ff65 50436-6126 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Unit Dose Services DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 50436-6140_f571913e-f403-433d-bad0-0466743c8c8d 50436-6140 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Unit Dose Services VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-6195_a40ab628-cb6c-4966-aa09-7160332829f5 50436-6195 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078434 Unit Dose Services KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 50436-6232_59ee6d3e-bacf-4888-adba-6f421d9e2603 50436-6232 HUMAN OTC DRUG MUCOSA GUAIFENESIN TABLET ORAL 20120416 OTC MONOGRAPH FINAL part341 Unit Dose Services GUAIFENESIN 400 mg/1 N 20181231 50436-6291_ff44699e-9b23-4cf1-86df-13af89b89bc8 50436-6291 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Unit Dose Services TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 50436-6301_323f622f-6ffb-4557-af9d-4ef6f40541e8 50436-6301 HUMAN PRESCRIPTION DRUG Bromday bromfenac SOLUTION/ DROPS OPHTHALMIC 20100920 NDA NDA021664 Unit Dose Services BROMFENAC SODIUM .9 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-6302_04ea34ab-7652-4fc3-97b0-c8bb9baac9d5 50436-6302 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031119 ANDA ANDA076467 Unit Dose Services GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50436-6304_0f5f2a54-442a-4653-bdf5-8b351956d0f4 50436-6304 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Unit Dose Services SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-6305_fc2f7db2-1614-4e5f-a32c-0f0ca9a9749d 50436-6305 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Unit Dose Services SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-6306_4c11eab8-c2f0-4bc7-a0a4-8f7c16dbccd5 50436-6306 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Unit Dose Services SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-6312_58071d44-eb11-405f-8a4a-b7bde7e810bc 50436-6312 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20140909 ANDA ANDA075536 Unit Dose Services DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 50436-6334_97cf6511-89f7-4ce5-a8f2-3b2e7e356963 50436-6334 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Unit Dose Services NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-6338_bb81a715-d800-46b5-af23-c4bdf8782b4f 50436-6338 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 Unit Dose Services QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 50436-6339_bb81a715-d800-46b5-af23-c4bdf8782b4f 50436-6339 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 Unit Dose Services QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 50436-6357_493a1a58-4349-4f95-a590-b91c91c5238f 50436-6357 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Unit Dose Services WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 50436-6358_4e801d72-02f8-4a34-8059-6f2e68037975 50436-6358 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Unit Dose Services WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 50436-6360_e17824de-1805-4e42-99ee-483aa3722732 50436-6360 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Unit Dose Services WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 50436-6363_025da0e8-eebc-4071-9424-9d36019bb420 50436-6363 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Unit Dose Services WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 50436-6364_c8ca0e56-72a0-4be3-b151-ac45b587536f 50436-6364 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150722 ANDA ANDA040616 Unit Dose Services WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 50436-6375_40f046dc-b484-43ba-9e68-be69090d0614 50436-6375 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Unit Dose Services ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-6400_c65ac35e-7a91-42f1-be5c-c30a89197a2b 50436-6400 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Unit Dose Services LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-6408_d80916b8-d975-4e82-b962-38807205766e 50436-6408 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Unit Dose Services GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50436-6409_a2ba73c1-2ace-4497-8bcd-3adb40f05eaf 50436-6409 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Unit Dose Services GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50436-6462_d16ad8b3-059d-41bd-8942-0e5ee0ab3a1e 50436-6462 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Unit Dose Services GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50436-6463_2838f077-c250-40ba-a153-3cc93e6b6a91 50436-6463 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Unit Dose Services GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50436-6500_ad3afc5a-6d08-4888-8f27-98450a14b2d5 50436-6500 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Unit Dose Services LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-6523_3703a561-d5b8-4931-8497-0a57383eff39 50436-6523 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Unit Dose Services PREGABALIN 75 mg/1 N 20181231 50436-6524_fce9d5b7-07f2-45a6-bf88-800631e2bcbe 50436-6524 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Unit Dose Services PREGABALIN 300 mg/1 N 20181231 50436-6525_32275776-636f-45e4-bb4e-6d194a74e176 50436-6525 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Unit Dose Services PREGABALIN 25 mg/1 CV N 20181231 50436-6526_3ceff1b7-a764-476a-bee9-6e4808bfc7d7 50436-6526 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Unit Dose Services PREGABALIN 100 mg/1 N 20181231 50436-6527_81a96dfa-e764-44d4-9947-342f88dc4e04 50436-6527 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Unit Dose Services PREGABALIN 150 mg/1 N 20181231 50436-6528_306c41c5-9231-400d-bb67-8feb59ea36fa 50436-6528 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Unit Dose Services PREGABALIN 200 mg/1 N 20181231 50436-6540_9e482cfc-1f55-48aa-9b15-362902afc807 50436-6540 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19981001 ANDA ANDA075034 Unit Dose Services GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 50436-6578_99fd3e64-2723-4ba6-a435-595239e2d2db 50436-6578 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090315 ANDA ANDA078459 Unit Dose Services METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-6579_a5f04fd8-d4d3-4cd2-b5a9-e93438b32faf 50436-6579 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA074644 Unit Dose Services METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-6585_c98cbc80-6a06-4c04-956c-fc90661787f8 50436-6585 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Unit Dose Services LEVOFLOXACIN 500 mg/1 N 20181231 50436-6590_ba2b93dc-76fb-4f79-a5ad-8642563003bd 50436-6590 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Unit Dose Services NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 50436-6591_c10f78f1-d9b1-4843-9162-ee73debee64e 50436-6591 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20070308 ANDA ANDA073652 Unit Dose Services NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 50436-6601_787912ad-5a6d-4287-8f3a-9fd48089c41e 50436-6601 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Unit Dose Services LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-6606_77e212d2-4bba-4135-97e7-51d247f785a1 50436-6606 HUMAN OTC DRUG good sense all day pain relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Unit Dose Services NAPROXEN SODIUM 220 mg/1 N 20181231 50436-6607_05a06d96-d8b1-43a4-a4d6-cf53f396bfae 50436-6607 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Unit Dose Services NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-6608_c28cfc98-f1eb-470f-83d4-130e24bb689b 50436-6608 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Unit Dose Services NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-6609_0199562b-d815-4542-a595-d77db699647a 50436-6609 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Unit Dose Services NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-6613_64fb6ab5-977e-4c48-8ca6-6d541b6f97e4 50436-6613 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Unit Dose Services NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-6617_729b230c-dba1-4c21-84ed-39fbf0c7a1b2 50436-6617 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Unit Dose Services PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-6624_692efcf4-b593-4233-9301-d457f15cd095 50436-6624 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Unit Dose Services AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50436-6650_6a3c3a25-e4fb-4321-8bca-e36e829936bf 50436-6650 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073554 Unit Dose Services NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-6651_984f18b4-55ac-42b1-abe8-37f2a2147dad 50436-6651 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073555 Unit Dose Services NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-6652_e7a205f3-bb66-4c1b-826d-4d34c8f09d81 50436-6652 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073553 Unit Dose Services NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 50436-6660_80718f51-1626-4f86-87fb-897f957f4007 50436-6660 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Unit Dose Services DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 50436-6664_ce060a7d-18d1-4fd5-8a98-4c25162c72f3 50436-6664 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Unit Dose Services LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50436-6665_9ebd882d-68b0-400f-b212-47fe2ee77f61 50436-6665 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078385 Unit Dose Services HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50436-6666_73ccaab7-6282-48c0-8f86-5f03260eb4c1 50436-6666 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA090528 Unit Dose Services HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50436-6667_155045cb-5d57-4315-a872-630663eb82fc 50436-6667 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA090528 Unit Dose Services HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50436-6668_ad93d991-e6cb-469a-8d70-cb3b0bef3f82 50436-6668 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Unit Dose Services LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50436-6669_706ad749-4ddd-463d-83e6-a72327e3d774 50436-6669 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Unit Dose Services LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 50436-6733_2a8bb3e8-eaef-4020-8c40-330f9612ddbf 50436-6733 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20080211 ANDA ANDA078391 Unit Dose Services HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50436-6743_0cfd103d-4e9d-4555-bcaf-d2d24a48adf4 50436-6743 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120815 ANDA ANDA040887 Unit Dose Services PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-6744_7099dd58-8d62-48ab-af45-1534c3acb244 50436-6744 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20050415 ANDA ANDA040555 Unit Dose Services PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-6745_671be0ff-6e88-43e3-917b-61100a21ffb0 50436-6745 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 Unit Dose Services PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-6746_dca6be28-7d5f-4e25-8d6e-b74e9f39ffca 50436-6746 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 Unit Dose Services PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-6752_846d26c3-9e4f-466a-870c-03438e73de47 50436-6752 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 19940511 ANDA ANDA064048 Unit Dose Services GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 50436-6753_a90756aa-b213-4faa-b711-a5c1a69769f6 50436-6753 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20081028 ANDA ANDA078536 Unit Dose Services CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 50436-6754_dfeb350f-80e2-412c-8363-8e9beee7c29e 50436-6754 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 19940511 ANDA ANDA064048 Unit Dose Services GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 50436-6755_5ec52e0b-9ae4-41d0-9dda-fc2a28b8898e 50436-6755 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Unit Dose Services TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50436-6756_69857599-9207-41e9-862c-78b55db14609 50436-6756 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Unit Dose Services TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 50436-6760_53f446d9-0533-4379-a1f9-268c29a832cf 50436-6760 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20130812 ANDA ANDA040526 Unit Dose Services PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-6810_7dacb813-62de-4145-95e3-3e4bafe053a8 50436-6810 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA073449 Unit Dose Services TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 50436-6811_c48b140d-03c4-499b-b0e9-e2d9495d691d 50436-6811 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090501 ANDA ANDA077415 Unit Dose Services BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50436-6858_204b5823-292b-40c7-bd6f-01b79a8e7f49 50436-6858 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50436-6859_e8e7d67d-23bd-4923-8dd7-ffa9325dbc0f 50436-6859 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 50436-6914_f546d3da-7038-4a76-b998-1e10255148af 50436-6914 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090917 ANDA ANDA078906 Unit Dose Services VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50436-6916_2466dd33-37f3-4a91-aec4-fccacf3434f3 50436-6916 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 Unit Dose Services VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50436-6924_b58508c4-66a0-4f7c-b2c8-f0f49aa791ff 50436-6924 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Unit Dose Services DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-6925_dee8075a-2d03-4359-bcc5-d130ef37b65b 50436-6925 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020109 ANDA ANDA075910 Unit Dose Services DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-6930_a03d0b1e-004b-4c41-9d19-21f5a6a10494 50436-6930 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Unit Dose Services RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50436-6942_be26121b-f1f0-44f7-88a0-a0602e43ab21 50436-6942 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Unit Dose Services RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50436-6951_fd5551a0-fbeb-4caa-84f4-ddb2e46e80c6 50436-6951 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20070609 ANDA ANDA077309 Unit Dose Services ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 50436-7000_d6e4ff81-2bdc-4cd0-be12-10326ef0087f 50436-7000 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20061004 ANDA ANDA077912 Unit Dose Services HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-7053_a4ae205e-3111-48b1-a1b1-2539ff522103 50436-7053 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Unit Dose Services METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-7054_1b36365e-dda2-428d-9da7-b501bb76b06a 50436-7054 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Unit Dose Services METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-7056_f8c5fb16-a7df-440b-aeaf-f17971ffb6e6 50436-7056 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Unit Dose Services METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 50436-7066_38fbfe5d-149f-4310-b16b-a56968eacc77 50436-7066 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20010327 ANDA ANDA040411 Unit Dose Services METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 50436-7067_4b396d80-abcb-4534-96b5-84b300be7ae2 50436-7067 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Unit Dose Services CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 50436-7073_8ad2195d-213e-4c30-8165-f04b87b9a0a8 50436-7073 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Unit Dose Services GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50436-7074_674ef5b8-2fe7-48b0-b77a-7ab86c6054c3 50436-7074 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Unit Dose Services GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50436-7075_1dcb7264-1f3b-432d-aaa6-ecf822cdac58 50436-7075 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Unit Dose Services GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 50436-7076_954d9a68-8b66-4ff8-886e-0b6c6ac5fbd9 50436-7076 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Unit Dose Services AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50436-7210_c3bd926e-5274-42be-88e6-b4d2051d5d42 50436-7210 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Unit Dose Services GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-7216_e658080f-3de4-412a-b5fd-a21f909475aa 50436-7216 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Unit Dose Services CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 50436-7218_89dbcc13-a496-4118-804d-902870124b46 50436-7218 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070301 ANDA ANDA065291 Unit Dose Services AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50436-7284_cc44dcb8-0938-4c45-b6e6-b603d1c6d0e0 50436-7284 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Unit Dose Services GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-7285_89f4ab86-a22f-45e4-9df1-a74e8474fc99 50436-7285 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Unit Dose Services GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-7286_5e36627a-09e8-4614-a046-9649af9ce2fb 50436-7286 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20080801 ANDA ANDA076017 Unit Dose Services GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50436-7350_fdb5104b-cb42-452f-83a7-fd49c1363ae1 50436-7350 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 ANDA ANDA077255 Unit Dose Services LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 50436-7370_f0970fdc-e432-47c1-8807-f58959d3caca 50436-7370 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Unit Dose Services FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50436-7371_1cfb6c8d-e054-4596-989e-dd2886d94877 50436-7371 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Unit Dose Services FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 50436-7376_0ef66670-4c90-4e96-808b-1c082058247c 50436-7376 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Unit Dose Services HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 50436-7379_97b738ba-5c1b-41e7-9be4-6922063a360e 50436-7379 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Unit Dose Services HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 50436-7382_c803082a-e64f-495a-ad05-56724bf9fe56 50436-7382 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 Unit Dose Services KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 50436-7392_73074e65-e6e6-44a9-a959-7cf0a5c62268 50436-7392 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19950109 ANDA ANDA062535 Unit Dose Services TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 50436-7601_258bd4ad-5886-4348-99dc-a496e07e309c 50436-7601 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Unit Dose Services ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50436-7602_5013c9e9-7e68-4d5f-ab6b-4ad95ab0d244 50436-7602 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Unit Dose Services CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-7701_4eb0c01b-f375-4c01-b53e-84c78cf319c2 50436-7701 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Unit Dose Services CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-7801_e0e82ccb-56bf-408b-9a53-7343315d6ee5 50436-7801 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Unit Dose Services CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-7901_4eb0c01b-f375-4c01-b53e-84c78cf319c2 50436-7901 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Unit Dose Services CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-7988_cdee60e6-2470-44ae-bb67-ff45584ce80d 50436-7988 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Unit Dose Services LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-8000_2eeaa323-5e45-4e06-aa0e-b6af68e0bf2c 50436-8000 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 Unit Dose Services HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-8101_84ff7247-2f9d-4cec-af0b-dac19b991af0 50436-8101 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20070910 ANDA ANDA077058 Unit Dose Services PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 50436-8102_35cd24c7-0159-4ad2-8c04-7d94375120fb 50436-8102 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 Unit Dose Services PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 50436-8675_2e43a98c-a38c-428b-bbb0-ed4baa8ac300 50436-8675 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20040923 ANDA ANDA065162 Unit Dose Services AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 50436-8700_7124e41d-20e7-483e-b9e5-a6e711cf8faa 50436-8700 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 Unit Dose Services LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-8787_5ebefee2-b56e-4553-bf97-c921384a8575 50436-8787 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Unit Dose Services TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50436-8788_29205219-3034-435c-a04a-f65586ff75b3 50436-8788 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111230 ANDA ANDA091607 Unit Dose Services TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50436-8900_05e04fd2-9902-49d1-a25e-534bd816c0a9 50436-8900 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 Unit Dose Services HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 50436-9022_c118215e-f1b8-4aff-9c46-da74338aff9c 50436-9022 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072234 Unit Dose Services BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 50436-9023_c92ec4eb-82c5-45ce-aacb-08c0e234098c 50436-9023 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072235 Unit Dose Services BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 50436-9028_d761706f-1f5b-4f11-be5c-7e88eb360fa9 50436-9028 HUMAN PRESCRIPTION DRUG phentermine hydrochloride phentermine hydrochloride CAPSULE ORAL 19810612 ANDA ANDA087190 Unit Dose Services PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-9029_24b06cb9-5212-4858-91a1-a867504eda97 50436-9029 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Unit Dose Services PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 50436-9036_b5b855be-c250-4a25-93a6-55a6f94abb81 50436-9036 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 19940601 ANDA ANDA074224 Unit Dose Services TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 50436-9054_e3381eaf-80da-463b-bd15-ed6c485bb935 50436-9054 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Unit Dose Services METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50436-9055_c409a1d3-b85e-4f30-a77d-1069d26890d1 50436-9055 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Unit Dose Services METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50436-9056_75848948-0d43-4874-8fa6-cde477932024 50436-9056 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Unit Dose Services METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50436-9071_efb3d059-ae8d-4c83-a780-e1bbd093c09c 50436-9071 HUMAN PRESCRIPTION DRUG TRANZGEL ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM GEL TRANSDERMAL 20100701 UNAPPROVED HOMEOPATHIC Unit Dose Services ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE 1; 1; 3; 3; 1; 1; 3; 1; 1; 1; 6; 4; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20181231 50436-9072_b3e5f18b-e26c-4b92-a2c6-b407a2efc147 50436-9072 HUMAN PRESCRIPTION DRUG SPEEDGEL RX ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE GEL TRANSDERMAL 20111201 UNAPPROVED HOMEOPATHIC Unit Dose Services ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE; GINGER 1; 1; 3; 1; 1; 1; 3; 1; 1; 1; 1; 3; 3; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 50436-9074_ce61371a-c75c-487d-9c33-55f9404dcb3a 50436-9074 HUMAN PRESCRIPTION DRUG SPEEDGEL RX ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE GEL TRANSDERMAL 20111201 UNAPPROVED HOMEOPATHIC Unit Dose Services ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE; GINGER 1; 1; 3; 1; 1; 1; 3; 1; 1; 1; 1; 3; 3; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 50436-9101_ebfed222-df25-4474-873c-aea5e9076b43 50436-9101 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Unit Dose Services BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 50436-9787_f21e57ec-1e49-4c31-aa2c-f13f0081aafc 50436-9787 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Unit Dose Services MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50436-9802_e1d34c06-3287-430a-9ef8-36d936eee416 50436-9802 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 20180731 ANDA ANDA077797 Unit Dose Services CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 50436-9803_9270b2e7-ac73-4680-aa5a-00c19c345bca 50436-9803 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Unit Dose Services ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-9887_87602381-d0a2-4795-9c66-168e8ebedee4 50436-9887 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 Unit Dose Services AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 50436-9933_27902e0d-aecf-40d0-9595-288c45a52e27 50436-9933 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Unit Dose Services WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 50436-9946_fde8e330-e3ac-4053-949d-652edd69c6b1 50436-9946 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Unit Dose Services WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 50436-9949_515a1bbb-9d40-4b63-bf5b-1d7909b7672c 50436-9949 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Unit Dose Services TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-9950_c2fa6157-6ad6-4024-bd46-8d3343cb18ff 50436-9950 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Unit Dose Services TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-9951_7270d2bd-c39c-428f-a629-174f386746e9 50436-9951 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Unit Dose Services TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-9952_72ead1c8-4794-4510-b056-a16682da2f76 50436-9952 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Unit Dose Services TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50436-9972_e95b8511-d38e-4444-8e95-7afcd2129d6b 50436-9972 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021210 Unit Dose Services LEVOTHYROXINE SODIUM ANHYDROUS .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 50436-9973_6a0cc439-2e10-4945-b266-f0a415d9cfec 50436-9973 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 19860723 ANDA ANDA089424 Unit Dose Services SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 50436-9976_0791a065-fe8c-42bd-bf32-03aa0ad5676f 50436-9976 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078790 Unit Dose Services DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 50436-9978_cbc10dc6-4d9a-4280-be5c-f7ca14cfa871 50436-9978 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA NDA020825 Unit Dose Services ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 50436-9979_752e1469-01c4-4058-876a-1cf212033d0c 50436-9979 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Unit Dose Services DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-9980_b8bb55bb-8cdc-4a1a-aa77-839d37ebea3c 50436-9980 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Unit Dose Services DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-9982_104f33ba-99ea-4d60-b0c7-c2f09c7db821 50436-9982 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 Unit Dose Services DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-9983_a0350885-4191-4403-bc5d-b59bdbdbb873 50436-9983 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Unit Dose Services ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-9985_f8817f00-6617-44a5-9853-9a49d848ed69 50436-9985 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate CREAM TOPICAL 19960930 ANDA ANDA074392 Unit Dose Services CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-9986_d2f13046-b901-4b53-a3d0-76fb752a2768 50436-9986 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 Unit Dose Services CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 50436-9987_d366553f-b55c-4df9-9293-1bafe5b5d933 50436-9987 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Unit Dose Services ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-9988_0d91948e-d79b-4d8d-abb2-7b2d5064b35d 50436-9988 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Unit Dose Services ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-9989_39d569b1-8944-4c67-8628-605ce43b618f 50436-9989 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Unit Dose Services ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 50436-9990_56985f25-b3d8-455a-bcd9-9584f6415779 50436-9990 HUMAN OTC DRUG Topical Pain Relief Methyl Salicylate, Menthol, capsaicin CREAM TOPICAL 20110115 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 5; .0355 g/100g; g/100g; g/100g N 20181231 50436-9991_48c078c9-bafb-4648-9610-ec3a0eec2b7f 50436-9991 HUMAN OTC DRUG MEDROX MENTHOL, CAPSAICIN PATCH TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g N 20181231 50436-9992_d307b7fb-c019-4499-b650-ec7a5452567f 50436-9992 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20080116 ANDA ANDA077570 Unit Dose Services FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50436-9993_fc412246-7fad-449e-870a-39730864ad73 50436-9993 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Unit Dose Services MILNACIPRAN HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50436-9994_a5301358-a8cd-436a-abb5-0494b1e5f15c 50436-9994 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 5; .0375 g/100g; g/100g; g/100g N 20181231 50436-9995_08c55b04-4e94-4866-9e22-46f116b2eb52 50436-9995 HUMAN OTC DRUG Terocin Methyl Salicylate, Capsaicin, Menthol and Lidocaine Hydrochloride LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services METHYL SALICYLATE; CAPSAICIN; MENTHOL; LIDOCAINE HYDROCHLORIDE 25; .025; 10; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 50436-9996_4d2cf4d7-cf34-4321-99b2-898db12ee338 50436-9996 HUMAN OTC DRUG New Terocin Methyl Salicylate, Capsaicin, and Menthol LOTION TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Unit Dose Services METHYL SALICYLATE; CAPSAICIN; MENTHOL 25; .025; 10 g/100mL; g/100mL; g/100mL N 20181231 50438-000_59010069-606b-4b93-b56e-653c6eae3a27 50438-000 HUMAN OTC DRUG ROYAL ALCOHOL CLEANSING PADS ISOPROPYL ALCOHOL LIQUID TOPICAL 20130729 OTC MONOGRAPH NOT FINAL part333A Filo America ISOPROPYL ALCOHOL .45 mg/g E 20171231 50438-001_61c73a37-7089-4062-8a0b-cf4647dc1765 50438-001 HUMAN OTC DRUG ROYAL Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL 20141029 OTC MONOGRAPH NOT FINAL part334 Filo America MAGNESIUM SULFATE 1 kg/kg N 20181231 50438-100_56cdf7a1-8490-47d5-bf58-d400f2ac9eda 50438-100 HUMAN OTC DRUG Virx Instant Hand Sanitizer with moisturizers and Vitamin E ALCOHOL GEL TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part333E Filo America ALCOHOL 62 mL/100mL N 20181231 50438-101_c6a8b618-d4a4-4c20-9a83-1ac6d9dc5d07 50438-101 HUMAN OTC DRUG Pacific Anti-bacterial Hand Cleanse Kiwi Essence Triclosan GEL TOPICAL 20130808 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL N 20181231 50438-102_515c193f-3aae-4fd0-b905-584e18c1ee79 50438-102 HUMAN OTC DRUG Pacific Anti-bacterial Hand Cleanse Blueberry Essence Triclosan GEL TOPICAL 20130808 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL N 20181231 50438-103_8d196a15-6dd5-4079-9235-a86f89dcb576 50438-103 HUMAN OTC DRUG Pacific Anti-bacterial Hand Cleanse Peach Essence Triclosan GEL TOPICAL 20130808 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL N 20181231 50438-104_1c5da675-5a4b-4c81-8977-6ecf24fe403a 50438-104 HUMAN OTC DRUG Pacific Anti-bacterial Hand Cleanse Strawberry Essence Triclosan GEL TOPICAL 20130808 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL N 20181231 50438-105_0c57dc16-b5f4-4cbe-82a4-77d3fa9798f8 50438-105 HUMAN OTC DRUG Royal Antibacterial Orange Berry Hand Cleanse Triclosan GEL TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL N 20181231 50438-106_dc31d249-4359-4cc3-abec-ab59ccef7378 50438-106 HUMAN OTC DRUG Royal Antibacterial Raspberry Hand Cleanse Triclosan GEL TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL N 20181231 50438-107_5ca9d71b-5e14-4d97-a492-a1d1e8ca1cf0 50438-107 HUMAN OTC DRUG Royal Antibacterial Passion Plum Hand Cleanse Triclosan GEL TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL N 20181231 50438-108_701409ce-fddc-4257-baeb-e18939be1d55 50438-108 HUMAN OTC DRUG Royal Antibacterial Tropical Fruit Hand Cleanse Triclosan GEL TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL N 20181231 50438-128_19e6c55a-4b14-4215-aa0a-a576b62b6968 50438-128 HUMAN OTC DRUG ANTIBACTERIAL BANDAGE benzalkonium chloride SWAB TOPICAL 20130816 OTC MONOGRAPH NOT FINAL part333A Filo America BENZALKONIUM CHLORIDE .12 g/100g E 20171231 50438-200_5bd06cd2-6ea1-4c7a-bde2-d5d35f66b17f 50438-200 HUMAN OTC DRUG Virx Instant Hand Sanitizer with security clip ALCOHOL GEL TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part333E Filo America ALCOHOL 62 mL/100mL N 20181231 50438-210_3b5edd70-a846-426a-ab44-018dc701f11e 50438-210 HUMAN OTC DRUG Oil-Free Acne Wash Salicylic Acid LOTION TOPICAL 20080608 OTC MONOGRAPH FINAL part333D Filo America SALICYLIC ACID 20 mg/mL N 20181231 50438-300_f132d80e-721f-4219-963e-43764aaa88bf 50438-300 HUMAN OTC DRUG Royal dandruff Dry Scalp Care PYRITHIONE ZINC SHAMPOO TOPICAL 20130917 OTC MONOGRAPH FINAL part358H Filo America PYRITHIONE ZINC 1 g/100mL N 20181231 50438-301_475471b0-8431-3e53-e054-00144ff8d46c 50438-301 HUMAN OTC DRUG Green MINT Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130730 OTC MONOGRAPH NOT FINAL part356 Filo America EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 50438-302_20145361-4fa7-45bf-a640-fdcc214c0269 50438-302 HUMAN OTC DRUG Peppermint Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130730 OTC MONOGRAPH NOT FINAL part356 Filo America EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 50438-303_3e53869c-ea36-4599-849f-ff629a1be9b7 50438-303 HUMAN OTC DRUG Amber Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130730 OTC MONOGRAPH NOT FINAL part356 Filo America EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 50438-304_1dd6b65e-11df-4ec2-93af-70888a53b1b1 50438-304 HUMAN OTC DRUG Royal Mouthwash Fresh and Clean Original Mint EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20130917 OTC MONOGRAPH NOT FINAL part356 Filo America EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 50438-400_c3d4fca4-d621-465a-b3a9-f0bef5779d40 50438-400 HUMAN OTC DRUG Royal Petroleum (Cocoa Scent) PETROLATUM JELLY TOPICAL 20140219 OTC MONOGRAPH FINAL part347 Filo America PETROLATUM 30 g/100g N 20181231 50438-401_bee0a22f-1615-45d0-bbf5-f30c48b0fe62 50438-401 HUMAN OTC DRUG Royal Petroleum (Vitamin E Enriched) PETROLATUM JELLY TOPICAL 20140219 OTC MONOGRAPH FINAL part347 Filo America PETROLATUM 30 g/100g N 20181231 50438-501_10caa662-d984-4ada-8ae7-3df087cb3506 50438-501 HUMAN OTC DRUG Ice ANALGESIC MENTHOL GEL TOPICAL 20150505 OTC MONOGRAPH NOT FINAL part348 Filo America MENTHOL 1 g/100g N 20181231 50438-502_025033fb-5b58-4edd-a7e7-882ffc2a2880 50438-502 HUMAN OTC DRUG Vaporizing Chest Rub Cough Supressant Camphor (Synthetic), Eucalyptus Oil, and Menthol OINTMENT TOPICAL 20150505 OTC MONOGRAPH FINAL part341 Filo America CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.7; 1; 1 g/100g; g/100g; g/100g N 20181231 50438-600_28e530b4-133e-43fe-b17f-43302454eddb 50438-600 HUMAN OTC DRUG Royal Antibacterial (coconut and lime) Triclosan GEL TOPICAL 20150604 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL N 20181231 50438-601_1255fcfa-030c-48b7-82aa-844840b9a863 50438-601 HUMAN OTC DRUG Royal Antibacterial (mango) Triclosan GEL TOPICAL 20150605 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL N 20181231 50438-602_2b8999bb-77b9-4ceb-89c0-08a52400a867 50438-602 HUMAN OTC DRUG Royal Antibacterial (apple and pear) moisturizing hand cleanse Triclosan GEL TOPICAL 20150605 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL N 20181231 50438-603_1eedb0ce-d81a-4ace-879b-a4e483e4556d 50438-603 HUMAN OTC DRUG Royal Antibacterial (coconut and lime) moisturizing hand cleanse Triclosan GEL TOPICAL 20150605 OTC MONOGRAPH NOT FINAL part333E Filo America TRICLOSAN 1.5 mg/mL N 20181231 50438-605_854825c0-9a15-4cf1-9f7b-7a0ecf4701ad 50438-605 HUMAN OTC DRUG basic essentials dandruff everyday clean PYRITHIONE ZINC SHAMPOO TOPICAL 20150610 OTC MONOGRAPH FINAL part358H Filo America PYRITHIONE ZINC 1 g/100mL N 20181231 50438-606_0931af4e-8fd6-48d7-bece-d2193fa7d676 50438-606 HUMAN OTC DRUG basic essentials dandruff (clean and conditioner) 2 in 1 everyday clean PYRITHIONE ZINC SHAMPOO TOPICAL 20150610 OTC MONOGRAPH FINAL part358H Filo America PYRITHIONE ZINC 1 g/100mL N 20181231 50438-607_f7c0686f-73d6-4105-8fcf-35152089bf41 50438-607 HUMAN OTC DRUG basic essentials dandruff dry scalp PYRITHIONE ZINC SHAMPOO TOPICAL 20150610 OTC MONOGRAPH FINAL part358H Filo America PYRITHIONE ZINC 1 g/100mL N 20181231 50438-807_e8c7b337-38d8-4848-b296-7673e5a987e8 50438-807 HUMAN OTC DRUG Virx Instant Hand Sanitizer GEL TOPICAL 20100211 OTC MONOGRAPH FINAL part333 Filo America ALCOHOL 496 mL/800mL E 20171231 50441-0001_c8c66c66-0932-4b32-8b8b-80f0972424ca 50441-0001 HUMAN OTC DRUG PainDefense Actaea spicata, Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Lemna minor, Lithium carbonicum, Magnesia phosphorica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus toxicodendron, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum LIQUID ORAL 20130806 UNAPPROVED HOMEOPATHIC PharmWest Inc. ACTAEA SPICATA ROOT; HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; LEMNA MINOR; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 50441-0002_7cdc345d-b78e-41dd-8d9d-7294f40f2966 50441-0002 HUMAN OTC DRUG Allergy and Hay Fever Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Arum triphyllum, Arundo mauritanica, Euphrasia officinalis, Naphthalinum, Natrum muriaticum, Sabadilla, Wyethia helenioides LIQUID ORAL 20121108 UNAPPROVED HOMEOPATHIC PharmWest Inc. ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; EUPHRASIA STRICTA; NAPHTHALENE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; WYETHIA HELENIOIDES ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 50441-0003_9c4ad935-0db7-4c92-9059-42b8a4c98ee0 50441-0003 HUMAN OTC DRUG Sinus Relief Apis mellifica, Baptisia tinctoria, Colocynthis, Hepar sulphuris calcareum, Histaminum hydrochloricum, Hydrastis canadensis, Ignatia amara, Kali bichromicum, Lemna minor, Mercurius vivus, Pulsatilla, Rhus toxicodendron, Sabadilla, Thuja occidentalis LIQUID ORAL 20131121 UNAPPROVED HOMEOPATHIC PharmWest Inc. APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LEMNA MINOR; MERCURY; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 50441-0005_6d73454f-5078-4de4-be5d-c6a6a2c48138 50441-0005 HUMAN OTC DRUG Cold and Flu Relief Aconitum napellus, Arsenicum album, Baptisia tinctoria, Bryonia, Causticum, Cinchona officinalis, Echinacea purpurea, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Influenzinum, Phytolacca decandra, Rhus toxicodendron, Sarcolacticum acidum, Sulphur, Wyethia helenioides, Zincum aceticum, Zincum muriaticum, Zincum oxydatum LIQUID ORAL 20131121 UNAPPROVED HOMEOPATHIC PharmWest Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; WYETHIA HELENIOIDES ROOT; ZINC ACETATE ANHYDROUS; ZINC CHLORIDE; ZINC OXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 50452-221_6587cd4a-676b-4a03-b5ad-14006c19a37c 50452-221 HUMAN OTC DRUG Pure Gel ALCOHOL GEL TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part333 Phoenix Research Industries, Inc. ALCOHOL .7 mL/mL E 20171231 50452-773_167bec9c-75c6-43ad-978b-b5862e435a7b 50452-773 HUMAN OTC DRUG Pure Foam ALCOHOL AEROSOL, FOAM TOPICAL 20100131 OTC MONOGRAPH NOT FINAL part333 Phoenix Research Industries, Inc. ALCOHOL 620 mg/g E 20171231 50458-090_91c9a17d-58a2-4ff3-97b4-f1e1c4dbd627 50458-090 HUMAN PRESCRIPTION DRUG DURAGESIC fentanyl PATCH TRANSDERMAL 19900807 NDA NDA019813 Janssen Pharmaceuticals, Inc. FENTANYL 12.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 50458-091_91c9a17d-58a2-4ff3-97b4-f1e1c4dbd627 50458-091 HUMAN PRESCRIPTION DRUG DURAGESIC fentanyl PATCH TRANSDERMAL 19900807 NDA NDA019813 Janssen Pharmaceuticals, Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 50458-092_91c9a17d-58a2-4ff3-97b4-f1e1c4dbd627 50458-092 HUMAN PRESCRIPTION DRUG DURAGESIC fentanyl PATCH TRANSDERMAL 19900807 NDA NDA019813 Janssen Pharmaceuticals, Inc. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 50458-093_91c9a17d-58a2-4ff3-97b4-f1e1c4dbd627 50458-093 HUMAN PRESCRIPTION DRUG DURAGESIC fentanyl PATCH TRANSDERMAL 19900807 NDA NDA019813 Janssen Pharmaceuticals, Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 50458-094_91c9a17d-58a2-4ff3-97b4-f1e1c4dbd627 50458-094 HUMAN PRESCRIPTION DRUG DURAGESIC fentanyl PATCH TRANSDERMAL 19900807 NDA NDA019813 Janssen Pharmaceuticals, Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 50458-098_c2e6eea1-81d2-4940-a173-5e454894317d 50458-098 HUMAN PRESCRIPTION DRUG ELMIRON PENTOSAN POLYSULFATE SODIUM CAPSULE, GELATIN COATED ORAL 19960926 NDA NDA020193 Janssen Pharmaceuticals, Inc. PENTOSAN POLYSULFATE SODIUM 100 mg/1 Glycosaminoglycan [EPC],Glycosaminoglycans [Chemical/Ingredient] N 20181231 50458-140_a68673e8-e33b-4978-8593-01318d94a53f 50458-140 HUMAN PRESCRIPTION DRUG INVOKANA canagliflozin TABLET, FILM COATED ORAL 20130329 NDA NDA204042 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN 100 mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50458-141_a68673e8-e33b-4978-8593-01318d94a53f 50458-141 HUMAN PRESCRIPTION DRUG INVOKANA canagliflozin TABLET, FILM COATED ORAL 20130329 NDA NDA204042 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN 300 mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50458-176_6a5368ca-daa5-11e7-bdde-e0f7d4b1bee7 50458-176 HUMAN PRESCRIPTION DRUG Ortho Novum 135 norethindrone and ethinyl estradiol KIT 19770623 NDA NDA017919 Janssen Pharmaceuticals, Inc. N 20181231 50458-178_6a5368ca-daa5-11e7-bdde-e0f7d4b1bee7 50458-178 HUMAN PRESCRIPTION DRUG Ortho-Novum 777 norethindrone and ethinyl estradiol KIT 19840404 NDA NDA018985 Janssen Pharmaceuticals, Inc. N 20181231 50458-191_761dc81a-aa38-43ab-96fa-87dd38657bed 50458-191 HUMAN PRESCRIPTION DRUG Ortho Tri Cyclen norgestimate and ethinyl estradiol KIT 19891229 NDA NDA019653 Janssen Pharmaceuticals, Inc. N 20181231 50458-192_91d2e319-86db-4f6d-bdf9-81795d6cf722 50458-192 HUMAN PRESCRIPTION DRUG Ortho Evra norelgestromin and ethinyl estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20011120 NDA NDA021180 Janssen Pharmaceutical, Inc. NORELGESTROMIN; ETHINYL ESTRADIOL 150; 35 ug/d; ug/d Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 50458-194_df27a691-e980-4aaa-ba3a-12b5c9dfecb5 50458-194 HUMAN PRESCRIPTION DRUG Ortho Micronor NORETHINDRONE TABLET ORAL 19730102 NDA NDA016954 Janssen Pharmaceuticals, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 50458-197_761dc81a-aa38-43ab-96fa-87dd38657bed 50458-197 HUMAN PRESCRIPTION DRUG Ortho Cyclen norgestimate and ethinyl estradiol KIT 19891229 NDA NDA019653 Janssen Pharmaceuticals, Inc. N 20181231 50458-210_c2890aae-3ca3-426d-ba03-19d9b99abe3b 50458-210 HUMAN PRESCRIPTION DRUG AXERT almotriptan malate TABLET, COATED ORAL 20010507 NDA NDA021001 Janssen Pharmaceuticals, Inc. ALMOTRIPTAN MALATE 12.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 50458-211_c2890aae-3ca3-426d-ba03-19d9b99abe3b 50458-211 HUMAN PRESCRIPTION DRUG AXERT almotriptan malate TABLET, COATED ORAL 20010507 NDA NDA021001 Janssen Pharmaceuticals, Inc. ALMOTRIPTAN MALATE 6.25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 50458-251_04bb626c-9442-4f3e-a965-672c00b0fc79 50458-251 HUMAN PRESCRIPTION DRUG ORTHO TRI CYCLEN Lo norgestimate and ethinyl estradiol KIT 20020822 NDA NDA021241 Janssen Pharmaceuticals, Inc. N 20181231 50458-253_a8486135-6aa8-4c95-a511-edaed7ad32c0 50458-253 HUMAN PRESCRIPTION DRUG Haldol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 19860114 NDA NDA018701 Janssen Pharmaceuticals, Inc. HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] N 20181231 50458-254_a8486135-6aa8-4c95-a511-edaed7ad32c0 50458-254 HUMAN PRESCRIPTION DRUG Haldol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 19860114 NDA NDA018701 Janssen Pharmaceuticals, Inc. HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] N 20181231 50458-255_c7cd5045-0d5c-4508-baed-8a29df6dd43d 50458-255 HUMAN PRESCRIPTION DRUG Haldol Haloperidol INJECTION INTRAMUSCULAR 19710518 NDA NDA015923 Janssen Pharmaceuticals, Inc. HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20181231 50458-290_b61076ee-a00a-45ba-b8c8-9278dca8c105 50458-290 HUMAN PRESCRIPTION DRUG SPORANOX ITRACONAZOLE CAPSULE ORAL 19920911 NDA NDA020083 Janssen Pharmaceuticals, Inc. ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50458-295_cd0edebc-1d6e-4b94-aa08-6829f6e60dc9 50458-295 HUMAN PRESCRIPTION DRUG SPORANOX itraconazole SOLUTION ORAL 19970221 NDA NDA020657 Janssen Pharmaceuticals, Inc. ITRACONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50458-300_b0182323-8924-4688-8456-35e92fe7fa75 50458-300 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceuticals, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-301_b0182323-8924-4688-8456-35e92fe7fa75 50458-301 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceuticals, Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-302_b0182323-8924-4688-8456-35e92fe7fa75 50458-302 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceuticals, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-305_b0182323-8924-4688-8456-35e92fe7fa75 50458-305 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone SOLUTION ORAL 19960610 NDA NDA020588 Janssen Pharmaceuticals, Inc. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 50458-306_2fb064a7-1ee7-4105-8431-7a176329ad10 50458-306 HUMAN PRESCRIPTION DRUG RISPERDAL CONSTA risperidone KIT 20031029 NDA NDA021346 Janssen Pharmaceuticals, Inc. N 20181231 50458-307_2fb064a7-1ee7-4105-8431-7a176329ad10 50458-307 HUMAN PRESCRIPTION DRUG RISPERDAL CONSTA risperidone KIT 20031029 NDA NDA021346 Janssen Pharmaceuticals, Inc. N 20181231 50458-308_2fb064a7-1ee7-4105-8431-7a176329ad10 50458-308 HUMAN PRESCRIPTION DRUG RISPERDAL CONSTA risperidone KIT 20031029 NDA NDA021346 Janssen Pharmaceuticals, Inc. N 20181231 50458-309_2fb064a7-1ee7-4105-8431-7a176329ad10 50458-309 HUMAN PRESCRIPTION DRUG RISPERDAL CONSTA risperidone KIT 20031029 NDA NDA021346 Janssen Pharmaceuticals, Inc. N 20181231 50458-315_b0182323-8924-4688-8456-35e92fe7fa75 50458-315 HUMAN PRESCRIPTION DRUG RISPERDAL M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceuticals, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-320_b0182323-8924-4688-8456-35e92fe7fa75 50458-320 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceuticals, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-325_b0182323-8924-4688-8456-35e92fe7fa75 50458-325 HUMAN PRESCRIPTION DRUG RISPERDAL M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceuticals, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-330_b0182323-8924-4688-8456-35e92fe7fa75 50458-330 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceuticals, Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-335_b0182323-8924-4688-8456-35e92fe7fa75 50458-335 HUMAN PRESCRIPTION DRUG RISPERDAL M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceuticals, Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-341_c9e43d34-a442-4db8-82b8-636f9ca562a2 50458-341 HUMAN PRESCRIPTION DRUG PANCREAZE PANCRELIPASE CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022523 Janssen Pharmaceuticals, Inc. PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE 4200; 24600; 14200 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 50458-342_c9e43d34-a442-4db8-82b8-636f9ca562a2 50458-342 HUMAN PRESCRIPTION DRUG PANCREAZE PANCRELIPASE CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022523 Janssen Pharmaceuticals, Inc. PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE 10500; 61500; 35500 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 50458-343_c9e43d34-a442-4db8-82b8-636f9ca562a2 50458-343 HUMAN PRESCRIPTION DRUG PANCREAZE PANCRELIPASE CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022523 Janssen Pharmaceuticals, Inc. PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE 16800; 98400; 56800 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 50458-346_c9e43d34-a442-4db8-82b8-636f9ca562a2 50458-346 HUMAN PRESCRIPTION DRUG PANCREAZE PANCRELIPASE CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022523 Janssen Pharmaceuticals, Inc. PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE 21000; 83900; 54700 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 50458-347_c9e43d34-a442-4db8-82b8-636f9ca562a2 50458-347 HUMAN PRESCRIPTION DRUG PANCREAZE PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE CAPSULE, DELAYED RELEASE ORAL 20160801 NDA NDA022523 Janssen Pharmaceuticals, Inc. PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE 2600; 10850; 6200 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 50458-350_b0182323-8924-4688-8456-35e92fe7fa75 50458-350 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceuticals, Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-355_b0182323-8924-4688-8456-35e92fe7fa75 50458-355 HUMAN PRESCRIPTION DRUG RISPERDAL M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceuticals, Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-387_3236b68d-e757-4f5e-bbb7-aed95ebc0d3b 50458-387 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20041224 NDA NDA021615 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 50458-388_3236b68d-e757-4f5e-bbb7-aed95ebc0d3b 50458-388 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20041224 NDA NDA021615 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 50458-389_3236b68d-e757-4f5e-bbb7-aed95ebc0d3b 50458-389 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide CAPSULE, EXTENDED RELEASE ORAL 20041224 NDA NDA021615 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 50458-395_b0182323-8924-4688-8456-35e92fe7fa75 50458-395 HUMAN PRESCRIPTION DRUG RISPERDAL M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceuticals, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-396_3236b68d-e757-4f5e-bbb7-aed95ebc0d3b 50458-396 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide TABLET, FILM COATED ORAL 20010301 NDA NDA021169 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 50458-397_3236b68d-e757-4f5e-bbb7-aed95ebc0d3b 50458-397 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide TABLET, FILM COATED ORAL 20010301 NDA NDA021169 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 50458-398_3236b68d-e757-4f5e-bbb7-aed95ebc0d3b 50458-398 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide TABLET, FILM COATED ORAL 20010301 NDA NDA021169 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 50458-490_3236b68d-e757-4f5e-bbb7-aed95ebc0d3b 50458-490 HUMAN PRESCRIPTION DRUG RAZADYNE galantamine hydrobromide SOLUTION ORAL 20010622 NDA NDA021224 Janssen Pharmaceuticals, Inc. GALANTAMINE HYDROBROMIDE 4 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 50458-513_911e2a95-e081-4aea-b756-2910630dc07d 50458-513 HUMAN PRESCRIPTION DRUG TYLENOL with Codeine acetaminophen and codeine phosphate TABLET ORAL 19770817 ANDA ANDA085055 Janssen Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 50458-515_911e2a95-e081-4aea-b756-2910630dc07d 50458-515 HUMAN PRESCRIPTION DRUG TYLENOL with Codeine acetaminophen and codeine phosphate TABLET ORAL 19770817 ANDA ANDA085055 Janssen Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 50458-531_7325732c-8475-4ed2-8189-4b9e2353be63 50458-531 HUMAN PRESCRIPTION DRUG Terazol 3 TERCONAZOLE SUPPOSITORY VAGINAL 19880524 NDA NDA019641 Janssen Pharmaceuticals, Inc. TERCONAZOLE 80 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 50458-535_7325732c-8475-4ed2-8189-4b9e2353be63 50458-535 HUMAN PRESCRIPTION DRUG Terazol 7 TERCONAZOLE CREAM VAGINAL 19871231 NDA NDA019579 Janssen Pharmaceuticals, Inc. TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 50458-536_7325732c-8475-4ed2-8189-4b9e2353be63 50458-536 HUMAN PRESCRIPTION DRUG Terazol 3 TERCONAZOLE CREAM VAGINAL 19910221 NDA NDA019964 Janssen Pharmaceuticals, Inc. TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 50458-540_217d3693-95c8-4556-a519-3a861991b2b6 50458-540 HUMAN PRESCRIPTION DRUG INVOKAMET canagliflozin and metformin hydrochloride TABLET, FILM COATED ORAL 20140808 NDA NDA204353 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 50; 500 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50458-541_217d3693-95c8-4556-a519-3a861991b2b6 50458-541 HUMAN PRESCRIPTION DRUG INVOKAMET canagliflozin and metformin hydrochloride TABLET, FILM COATED ORAL 20140808 NDA NDA204353 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 50; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50458-542_217d3693-95c8-4556-a519-3a861991b2b6 50458-542 HUMAN PRESCRIPTION DRUG INVOKAMET canagliflozin and metformin hydrochloride TABLET, FILM COATED ORAL 20140808 NDA NDA204353 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 150; 500 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50458-543_217d3693-95c8-4556-a519-3a861991b2b6 50458-543 HUMAN PRESCRIPTION DRUG INVOKAMET canagliflozin and metformin hydrochloride TABLET, FILM COATED ORAL 20140808 NDA NDA204353 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 150; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50458-550_a18f9498-e4ff-460d-a181-77abf702fe18 50458-550 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20061219 NDA NDA021999 Janssen Pharmaceuticals, Inc. PALIPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20191231 50458-551_a18f9498-e4ff-460d-a181-77abf702fe18 50458-551 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20061219 NDA NDA021999 Janssen Pharmaceuticals, Inc. PALIPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] N 20191231 50458-552_a18f9498-e4ff-460d-a181-77abf702fe18 50458-552 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20061219 NDA NDA021999 Janssen Pharmaceuticals, Inc. PALIPERIDONE 9 mg/1 Atypical Antipsychotic [EPC] N 20191231 50458-554_a18f9498-e4ff-460d-a181-77abf702fe18 50458-554 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20090910 NDA NDA021999 Janssen Pharmaceuticals, Inc. PALIPERIDONE 1.5 mg/1 Atypical Antipsychotic [EPC] N 20191231 50458-560_12c2bcb8-2521-4d40-ba85-a4508ca37fe0 50458-560 HUMAN PRESCRIPTION DRUG INVEGA SUSTENNA paliperidone palmitate INJECTION INTRAMUSCULAR 20090731 NDA NDA022264 Janssen Pharmaceuticals, Inc. PALIPERIDONE PALMITATE 39 mg/.25mL Atypical Antipsychotic [EPC] N 20181231 50458-561_12c2bcb8-2521-4d40-ba85-a4508ca37fe0 50458-561 HUMAN PRESCRIPTION DRUG INVEGA SUSTENNA paliperidone palmitate INJECTION INTRAMUSCULAR 20090731 NDA NDA022264 Janssen Pharmaceuticals, Inc. PALIPERIDONE PALMITATE 78 mg/.5mL Atypical Antipsychotic [EPC] N 20181231 50458-562_12c2bcb8-2521-4d40-ba85-a4508ca37fe0 50458-562 HUMAN PRESCRIPTION DRUG INVEGA SUSTENNA paliperidone palmitate INJECTION INTRAMUSCULAR 20090731 NDA NDA022264 Janssen Pharmaceuticals, Inc. PALIPERIDONE PALMITATE 117 mg/.75mL Atypical Antipsychotic [EPC] N 20181231 50458-563_12c2bcb8-2521-4d40-ba85-a4508ca37fe0 50458-563 HUMAN PRESCRIPTION DRUG INVEGA SUSTENNA paliperidone palmitate INJECTION INTRAMUSCULAR 20090731 NDA NDA022264 Janssen Pharmaceuticals, Inc. PALIPERIDONE PALMITATE 156 mg/mL Atypical Antipsychotic [EPC] N 20181231 50458-564_12c2bcb8-2521-4d40-ba85-a4508ca37fe0 50458-564 HUMAN PRESCRIPTION DRUG INVEGA SUSTENNA paliperidone palmitate INJECTION INTRAMUSCULAR 20090731 NDA NDA022264 Janssen Pharmaceuticals, Inc. PALIPERIDONE PALMITATE 234 mg/1.5mL Atypical Antipsychotic [EPC] N 20181231 50458-578_7db43726-eb28-48c0-b367-d759e5067bdc 50458-578 HUMAN PRESCRIPTION DRUG Xarelto rivaroxaban TABLET, FILM COATED ORAL 20111104 NDA NDA202439 Janssen Pharmaceuticals, Inc. RIVAROXABAN 15 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] N 20181231 50458-579_7db43726-eb28-48c0-b367-d759e5067bdc 50458-579 HUMAN PRESCRIPTION DRUG Xarelto rivaroxaban TABLET, FILM COATED ORAL 20111105 NDA NDA202439 Janssen Pharmaceuticals, Inc. RIVAROXABAN 20 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] N 20181231 50458-580_7db43726-eb28-48c0-b367-d759e5067bdc 50458-580 HUMAN PRESCRIPTION DRUG Xarelto rivaroxaban TABLET, FILM COATED ORAL 20110701 NDA NDA022406 Janssen Pharmaceuticals, Inc. RIVAROXABAN 10 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] N 20181231 50458-584_7db43726-eb28-48c0-b367-d759e5067bdc 50458-584 HUMAN PRESCRIPTION DRUG XARELTO Rivaroxaban KIT 20140916 NDA NDA022406 Janssen Pharmaceuticals, Inc. N 20181231 50458-585_c88b1b05-a937-4ef6-96ef-af2104f09111 50458-585 HUMAN PRESCRIPTION DRUG CONCERTA Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20000801 NDA NDA021121 Janssen Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 50458-586_c88b1b05-a937-4ef6-96ef-af2104f09111 50458-586 HUMAN PRESCRIPTION DRUG CONCERTA Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20000801 NDA NDA021121 Janssen Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 50458-587_c88b1b05-a937-4ef6-96ef-af2104f09111 50458-587 HUMAN PRESCRIPTION DRUG CONCERTA Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20000801 NDA NDA021121 Janssen Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 50458-588_c88b1b05-a937-4ef6-96ef-af2104f09111 50458-588 HUMAN PRESCRIPTION DRUG CONCERTA Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20000801 NDA NDA021121 Janssen Pharmaceuticals, Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 50458-590_398d9d74-0e8c-41c1-9948-23e2a0e81c0b 50458-590 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceutical, Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-591_398d9d74-0e8c-41c1-9948-23e2a0e81c0b 50458-591 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceutical, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-592_398d9d74-0e8c-41c1-9948-23e2a0e81c0b 50458-592 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceutical, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-593_398d9d74-0e8c-41c1-9948-23e2a0e81c0b 50458-593 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceutical, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-594_398d9d74-0e8c-41c1-9948-23e2a0e81c0b 50458-594 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceutical, Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-595_398d9d74-0e8c-41c1-9948-23e2a0e81c0b 50458-595 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Janssen Pharmaceutical, Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-596_398d9d74-0e8c-41c1-9948-23e2a0e81c0b 50458-596 HUMAN PRESCRIPTION DRUG Risperidone risperidone SOLUTION ORAL 19960610 NDA NDA020588 Janssen Pharmaceutical, Inc. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 50458-601_398d9d74-0e8c-41c1-9948-23e2a0e81c0b 50458-601 HUMAN PRESCRIPTION DRUG Risperidone M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceutical, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-602_398d9d74-0e8c-41c1-9948-23e2a0e81c0b 50458-602 HUMAN PRESCRIPTION DRUG Risperidone M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceutical, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-603_398d9d74-0e8c-41c1-9948-23e2a0e81c0b 50458-603 HUMAN PRESCRIPTION DRUG Risperidone M-TAB risperidone TABLET, ORALLY DISINTEGRATING ORAL 20030402 NDA NDA021444 Janssen Pharmaceutical, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 50458-606_cee057fd-9f3d-43d0-8779-0230b0d187c1 50458-606 HUMAN PRESCRIPTION DRUG INVEGA TRINZA paliperidone palmitate INJECTION, SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 20150519 NDA NDA207946 Janssen Pharmaceuticals, Inc PALIPERIDONE PALMITATE 273 mg/.875mL Atypical Antipsychotic [EPC] N 20181231 50458-607_cee057fd-9f3d-43d0-8779-0230b0d187c1 50458-607 HUMAN PRESCRIPTION DRUG INVEGA TRINZA paliperidone palmitate INJECTION, SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 20150519 NDA NDA207946 Janssen Pharmaceuticals, Inc PALIPERIDONE PALMITATE 410 mg/1.315mL Atypical Antipsychotic [EPC] N 20181231 50458-608_cee057fd-9f3d-43d0-8779-0230b0d187c1 50458-608 HUMAN PRESCRIPTION DRUG INVEGA TRINZA paliperidone palmitate INJECTION, SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 20150519 NDA NDA207946 Janssen Pharmaceuticals, Inc PALIPERIDONE PALMITATE 546 mg/1.75mL Atypical Antipsychotic [EPC] N 20181231 50458-609_cee057fd-9f3d-43d0-8779-0230b0d187c1 50458-609 HUMAN PRESCRIPTION DRUG INVEGA TRINZA paliperidone palmitate INJECTION, SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 20150519 NDA NDA207946 Janssen Pharmaceuticals, Inc PALIPERIDONE PALMITATE 819 mg/2.625mL Atypical Antipsychotic [EPC] N 20181231 50458-639_2989ad6f-4145-4b83-b1e9-f6afa236df8f 50458-639 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Janssen Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50458-640_2989ad6f-4145-4b83-b1e9-f6afa236df8f 50458-640 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Janssen Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50458-641_2989ad6f-4145-4b83-b1e9-f6afa236df8f 50458-641 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Janssen Pharmaceuticals, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50458-642_2989ad6f-4145-4b83-b1e9-f6afa236df8f 50458-642 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Janssen Pharmaceuticals, Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50458-645_2989ad6f-4145-4b83-b1e9-f6afa236df8f 50458-645 HUMAN PRESCRIPTION DRUG Topamax topiramate CAPSULE, COATED PELLETS ORAL 19981101 NDA NDA020844 Janssen Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50458-647_2989ad6f-4145-4b83-b1e9-f6afa236df8f 50458-647 HUMAN PRESCRIPTION DRUG Topamax topiramate CAPSULE, COATED PELLETS ORAL 19981101 NDA NDA020844 Janssen Pharmaceuticals, Inc. TOPIRAMATE 15 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 50458-650_eab2a296-02a3-44da-9337-fd04185f71f4 50458-650 HUMAN PRESCRIPTION DRUG ULTRACET tramadol hydrochloride and acetaminophen TABLET, COATED ORAL 20010815 NDA NDA021123 Janssen Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50458-653_96bec1b6-7ff2-4e89-be58-d5c359fb51f4 50458-653 HUMAN PRESCRIPTION DRUG Ultram ER Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20051001 NDA NDA021692 Janssen Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50458-655_96bec1b6-7ff2-4e89-be58-d5c359fb51f4 50458-655 HUMAN PRESCRIPTION DRUG Ultram ER Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20051001 NDA NDA021692 Janssen Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50458-657_96bec1b6-7ff2-4e89-be58-d5c359fb51f4 50458-657 HUMAN PRESCRIPTION DRUG Ultram ER Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20051001 NDA NDA021692 Janssen Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50458-659_776c0657-469b-4a0f-9adf-00b05b475d67 50458-659 HUMAN PRESCRIPTION DRUG ULTRAM tramadol hydrochloride TABLET, COATED ORAL 19950303 NDA NDA020281 Janssen Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 50458-675_086f72d0-a9b6-46ea-ac0d-53a4999fa3a2 50458-675 HUMAN PRESCRIPTION DRUG VERMOX mebendazole TABLET, CHEWABLE ORAL 20161020 NDA NDA208398 Janssen Pharmaceuticals, Inc. MEBENDAZOLE 500 mg/1 Antihelminthic [EPC] N 20181231 50458-680_06febdbd-2183-4776-8243-754a5ca16211 50458-680 HUMAN PRESCRIPTION DRUG Nizoral ketoconazole SHAMPOO TOPICAL 19900831 NDA NDA019927 Janssen Pharmaceuticals, Inc. KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 50458-805_48d813b7-3c57-4c0c-8b4f-9ce60ba809ed 50458-805 HUMAN PRESCRIPTION DRUG Ditropan XL oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 19990626 NDA NDA020897 Janssen Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 50458-810_48d813b7-3c57-4c0c-8b4f-9ce60ba809ed 50458-810 HUMAN PRESCRIPTION DRUG Ditropan XL oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 19990626 NDA NDA020897 Janssen Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 50458-815_48d813b7-3c57-4c0c-8b4f-9ce60ba809ed 50458-815 HUMAN PRESCRIPTION DRUG Ditropan XL oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 19990626 NDA NDA020897 Janssen Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 50458-817_6554342f-4aa7-4ef4-bcef-e1a7e3a84991 50458-817 HUMAN PRESCRIPTION DRUG Nucynta tapentadol hydrochloride SOLUTION ORAL 20121015 NDA NDA203794 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 20 mg/mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50458-820_b3bc3bb7-1cb6-4d72-bc00-9a2bf1492b03 50458-820 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50458-830_b3bc3bb7-1cb6-4d72-bc00-9a2bf1492b03 50458-830 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 75 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50458-840_b3bc3bb7-1cb6-4d72-bc00-9a2bf1492b03 50458-840 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50458-860_bdb7e201-5be5-44cf-8b9f-a9a885112b96 50458-860 HUMAN PRESCRIPTION DRUG Nucynta ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50458-861_bdb7e201-5be5-44cf-8b9f-a9a885112b96 50458-861 HUMAN PRESCRIPTION DRUG Nucynta ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50458-862_bdb7e201-5be5-44cf-8b9f-a9a885112b96 50458-862 HUMAN PRESCRIPTION DRUG Nucynta ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 150 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50458-863_bdb7e201-5be5-44cf-8b9f-a9a885112b96 50458-863 HUMAN PRESCRIPTION DRUG Nucynta ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 200 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50458-864_bdb7e201-5be5-44cf-8b9f-a9a885112b96 50458-864 HUMAN PRESCRIPTION DRUG Nucynta ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Janssen Pharmaceuticals, Inc. TAPENTADOL HYDROCHLORIDE 250 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 50458-920_755a9621-13b0-4162-b0f9-3fe67edd88f3 50458-920 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Janssen Pharmaceuticals, Inc. LEVOFLOXACIN 250 mg/1 N 20191231 50458-925_755a9621-13b0-4162-b0f9-3fe67edd88f3 50458-925 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Janssen Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20191231 50458-930_755a9621-13b0-4162-b0f9-3fe67edd88f3 50458-930 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Janssen Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 N 20191231 50458-940_b1940fea-9706-4998-8d23-cdda61bb3cd9 50458-940 HUMAN PRESCRIPTION DRUG INVOKAMET XR canagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160920 NDA NDA205879 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 50; 500 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 50458-941_b1940fea-9706-4998-8d23-cdda61bb3cd9 50458-941 HUMAN PRESCRIPTION DRUG INVOKAMET XR canagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160920 NDA NDA205879 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 50; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 50458-942_b1940fea-9706-4998-8d23-cdda61bb3cd9 50458-942 HUMAN PRESCRIPTION DRUG INVOKAMET XR canagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160920 NDA NDA205879 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 150; 500 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 50458-943_b1940fea-9706-4998-8d23-cdda61bb3cd9 50458-943 HUMAN PRESCRIPTION DRUG INVOKAMET XR canagliflozin and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160920 NDA NDA205879 Janssen Pharmaceuticals, Inc. CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE 150; 1000 mg/1; mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 50462-107_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-107 HUMAN OTC DRUG Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20120704 OTC MONOGRAPH FINAL part348 ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC METHYL SALICYLATE; MENTHOL 30; 14.5 mL/100mL; mL/100mL E 20171231 50462-110_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-110 HUMAN OTC DRUG Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20120704 OTC MONOGRAPH FINAL part348 ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC METHYL SALICYLATE; MENTHOL 30; 14.5 mL/100mL; mL/100mL E 20171231 50462-113_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-113 HUMAN OTC DRUG Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20120704 OTC MONOGRAPH FINAL part348 ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC METHYL SALICYLATE; MENTHOL 30; 14.5 mL/100mL; mL/100mL E 20171231 50462-114_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-114 HUMAN OTC DRUG Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20120704 OTC MONOGRAPH FINAL part348 ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC METHYL SALICYLATE; MENTHOL 30; 14.5 mL/100mL; mL/100mL E 20171231 50462-115_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-115 HUMAN OTC DRUG Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20120704 OTC MONOGRAPH FINAL part348 ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC METHYL SALICYLATE; MENTHOL 30; 14.5 mL/100mL; mL/100mL E 20171231 50462-119_a3c86cb1-8bc6-4b16-8256-fe6e305acb75 50462-119 HUMAN OTC DRUG Noble Lion Medicated Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20120704 OTC MONOGRAPH FINAL part348 ABBP (ARRINGTON, BATTLE, BELL & PERRY), LLC METHYL SALICYLATE; MENTHOL 30; 14.5 mL/100mL; mL/100mL E 20171231 50466-575_6f22381d-e90d-4a1d-bffc-705ca89ad96b 50466-575 HUMAN OTC DRUG Foaming Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part333 Interstate Solutions, Inc. BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 50474-001_5d675a50-b11f-4fd5-e053-2a91aa0a9474 50474-001 HUMAN PRESCRIPTION DRUG Keppra levetiracetam SOLUTION ORAL 20031020 NDA NDA021505 UCB, Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 50474-002_5d678568-65a3-0d1b-e053-2991aa0a7335 50474-002 HUMAN PRESCRIPTION DRUG Keppra levetiracetam INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060823 NDA NDA021872 UCB, Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50474-370_7d59b2b8-0e38-4a6a-8e63-488ca47a0288 50474-370 HUMAN PRESCRIPTION DRUG Briviact brivaracetam TABLET, FILM COATED ORAL 20160512 NDA NDA205836 UCB, Inc. BRIVARACETAM 10 mg/1 Epoxide Hydrolase Inhibitors [MoA] CV N 20181231 50474-470_7d59b2b8-0e38-4a6a-8e63-488ca47a0288 50474-470 HUMAN PRESCRIPTION DRUG Briviact brivaracetam TABLET, FILM COATED ORAL 20160512 NDA NDA205836 UCB, Inc. BRIVARACETAM 25 mg/1 Epoxide Hydrolase Inhibitors [MoA] CV N 20181231 50474-570_7d59b2b8-0e38-4a6a-8e63-488ca47a0288 50474-570 HUMAN PRESCRIPTION DRUG Briviact brivaracetam TABLET, FILM COATED ORAL 20160512 NDA NDA205836 UCB, Inc. BRIVARACETAM 50 mg/1 Epoxide Hydrolase Inhibitors [MoA] CV N 20181231 50474-594_5d675a50-b11f-4fd5-e053-2a91aa0a9474 50474-594 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 UCB, Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 50474-595_5d675a50-b11f-4fd5-e053-2a91aa0a9474 50474-595 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 UCB, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 50474-596_5d675a50-b11f-4fd5-e053-2a91aa0a9474 50474-596 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 UCB, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 50474-597_5d675a50-b11f-4fd5-e053-2a91aa0a9474 50474-597 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 UCB, Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 50474-598_5d677e9f-b551-5296-e053-2a91aa0a6052 50474-598 HUMAN PRESCRIPTION DRUG Keppra XR levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080924 NDA NDA022285 UCB, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50474-599_5d677e9f-b551-5296-e053-2a91aa0a6052 50474-599 HUMAN PRESCRIPTION DRUG Keppra XR levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090401 NDA NDA022285 UCB, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 50474-670_7d59b2b8-0e38-4a6a-8e63-488ca47a0288 50474-670 HUMAN PRESCRIPTION DRUG Briviact brivaracetam TABLET, FILM COATED ORAL 20160512 NDA NDA205836 UCB, Inc. BRIVARACETAM 75 mg/1 Epoxide Hydrolase Inhibitors [MoA] CV N 20181231 50474-700_02283a90-77a9-4af2-81c6-fec71632fb9e 50474-700 HUMAN PRESCRIPTION DRUG Cimzia certolizumab pegol KIT 20080420 BLA BLA125160 UCB, Inc. N 20181231 50474-710_02283a90-77a9-4af2-81c6-fec71632fb9e 50474-710 HUMAN PRESCRIPTION DRUG Cimzia certolizumab pegol INJECTION, SOLUTION SUBCUTANEOUS 20090514 BLA BLA125160 UCB, Inc. CERTOLIZUMAB PEGOL 200 mg/mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] N 20181231 50474-770_7d59b2b8-0e38-4a6a-8e63-488ca47a0288 50474-770 HUMAN PRESCRIPTION DRUG Briviact brivaracetam TABLET, FILM COATED ORAL 20160512 NDA NDA205836 UCB, Inc. BRIVARACETAM 100 mg/1 Epoxide Hydrolase Inhibitors [MoA] CV N 20181231 50474-801_0bb12d38-8fec-4b7f-8bfa-87ba7014a464 50474-801 HUMAN PRESCRIPTION DRUG Neupro rotigotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120402 NDA NDA021829 UCB, Inc. ROTIGOTINE 1 mg/24h N 20181231 50474-802_0bb12d38-8fec-4b7f-8bfa-87ba7014a464 50474-802 HUMAN PRESCRIPTION DRUG Neupro rotigotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120402 NDA NDA021829 UCB, Inc. ROTIGOTINE 2 mg/24h N 20181231 50474-803_0bb12d38-8fec-4b7f-8bfa-87ba7014a464 50474-803 HUMAN PRESCRIPTION DRUG Neupro rotigotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120402 NDA NDA021829 UCB, Inc. ROTIGOTINE 3 mg/24h N 20181231 50474-804_0bb12d38-8fec-4b7f-8bfa-87ba7014a464 50474-804 HUMAN PRESCRIPTION DRUG Neupro rotigotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120402 NDA NDA021829 UCB, Inc. ROTIGOTINE 4 mg/24h N 20181231 50474-805_0bb12d38-8fec-4b7f-8bfa-87ba7014a464 50474-805 HUMAN PRESCRIPTION DRUG Neupro rotigotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120402 NDA NDA021829 UCB, Inc. ROTIGOTINE 6 mg/24h N 20181231 50474-806_0bb12d38-8fec-4b7f-8bfa-87ba7014a464 50474-806 HUMAN PRESCRIPTION DRUG Neupro rotigotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120402 NDA NDA021829 UCB, Inc. ROTIGOTINE 8 mg/24h N 20181231 50474-808_0bb12d38-8fec-4b7f-8bfa-87ba7014a464 50474-808 HUMAN PRESCRIPTION DRUG Neupro rotigotine KIT 20120402 NDA NDA021829 UCB, Inc. N 20181231 50474-870_7d59b2b8-0e38-4a6a-8e63-488ca47a0288 50474-870 HUMAN PRESCRIPTION DRUG Briviact brivaracetam SOLUTION ORAL 20160512 NDA NDA205838 UCB, Inc. BRIVARACETAM 10 mg/mL Epoxide Hydrolase Inhibitors [MoA] CV N 20181231 50474-920_b52bea04-cd52-4ea3-807e-a2e33a76c5c0 50474-920 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride TABLET, FILM COATED ORAL 20070809 20190119 NDA NDA022064 UCB, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 50474-921_b52bea04-cd52-4ea3-807e-a2e33a76c5c0 50474-921 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride SOLUTION ORAL 20080402 20180608 NDA NDA022157 UCB, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 50474-970_7d59b2b8-0e38-4a6a-8e63-488ca47a0288 50474-970 HUMAN PRESCRIPTION DRUG Briviact brivaracetam INJECTION, SUSPENSION INTRAVENOUS 20160512 NDA NDA205837 UCB, Inc. BRIVARACETAM 50 mg/5mL Epoxide Hydrolase Inhibitors [MoA] CV N 20181231 50481-3201_84d728d6-b6f1-4df6-84e0-0bb157ca7567 50481-3201 HUMAN OTC DRUG Tussy Antiperspirant and Deodorant Original Fresh Spice ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100127 OTC MONOGRAPH FINAL part350 KCM Brands LLC ALUMINUM CHLOROHYDRATE 19 mL/100mL E 20171231 50481-3300_60e2c59d-007d-a31a-e053-2a91aa0a7578 50481-3300 HUMAN OTC DRUG Tussy Antiperspirant and Deodorant Invisible Original Fresh Spice ALUMINUM CHLOROHYDRATE STICK TOPICAL 20100127 OTC MONOGRAPH FINAL part350 KCM Brands LLC ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 50484-010_af5af2b1-765a-4ff8-94d0-795655bf70a5 50484-010 HUMAN PRESCRIPTION DRUG COLLAGENASE SANTYL COLLAGENASE SANTYL OINTMENT TOPICAL 20061018 BLA BLA101995 SMITH & NEPHEW, INC COLLAGENASE CLOSTRIDIUM HISTOLYTICUM 250 [arb'U]/g Collagenases [Chemical/Ingredient],Collagen-specific Enzyme [EPC] N 20181231 50484-044_7826d5e7-2fd4-4490-a3e2-614ef923b8e1 50484-044 HUMAN OTC DRUG PROSHIELD PLUS SKIN PROTECTANT DIMETHICONE OINTMENT TOPICAL 19970101 OTC MONOGRAPH FINAL part347 Smith & Nephew, Inc. DIMETHICONE .01 g/g N 20191231 50484-212_34991422-e43d-4ed5-bed6-b1ae9f470005 50484-212 HUMAN OTC DRUG I.V. Prep Antiseptic Wipe ISOPROPYL ALCOHOL SOLUTION TOPICAL 19991001 20180630 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew, Inc. ISOPROPYL ALCOHOL .57 1/1 N 20181231 50484-302_c42e7ff0-d2e5-4868-a9b6-441695f431e3 50484-302 HUMAN OTC DRUG Secura Total Body Foam Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 20180731 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 ug/mL N 20181231 50484-303_c42e7ff0-d2e5-4868-a9b6-441695f431e3 50484-303 HUMAN OTC DRUG Secura Total Body Foam Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 20180731 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 ug/mL N 20181231 50484-304_55595908-eb3f-4e53-a6e9-0a8897f00f60 50484-304 HUMAN OTC DRUG Secura Personal Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 20180731 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 ug/mL N 20181231 50484-305_55595908-eb3f-4e53-a6e9-0a8897f00f60 50484-305 HUMAN OTC DRUG Secura Personal Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 20180731 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 mg/L N 20181231 50484-308_c2b49409-483f-4b6f-b441-a16992befe4b 50484-308 HUMAN OTC DRUG Secura Moisturizing Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 20221231 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 ug/mL N 20181231 50484-309_c2b49409-483f-4b6f-b441-a16992befe4b 50484-309 HUMAN OTC DRUG Secura Moisturizing Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 20221231 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 ug/mL N 20181231 50484-311_a4ebdf39-83e5-4f3a-89b8-ad2dcaa342f6 50484-311 HUMAN OTC DRUG Secura Protective ZINC OXIDE CREAM TOPICAL 20030801 20200731 OTC MONOGRAPH FINAL part347 Smith & Nephew, Inc. ZINC OXIDE 100 mg/g N 20181231 50484-312_a4ebdf39-83e5-4f3a-89b8-ad2dcaa342f6 50484-312 HUMAN OTC DRUG Secura Protective ZINC OXIDE CREAM TOPICAL 20030801 20200731 OTC MONOGRAPH FINAL part347 Smith & Nephew, Inc. ZINC OXIDE 100 mg/g N 20181231 50484-315_acb3a980-0ba7-436c-a707-77a788fe2312 50484-315 HUMAN OTC DRUG Secura Protective PETROLATUM OINTMENT TOPICAL 20030801 20180731 OTC MONOGRAPH FINAL part347 Smith & Nephew, Inc. PETROLATUM 987.89 mg/g N 20181231 50484-316_acb3a980-0ba7-436c-a707-77a788fe2312 50484-316 HUMAN OTC DRUG Secura Protective PETROLATUM OINTMENT TOPICAL 20030801 20180731 OTC MONOGRAPH FINAL part347 Smith & Nephew, Inc. PETROLATUM 987.89 mg/g N 20181231 50484-322_54103054-7c98-4f4f-9cd6-3fe1c053c587 50484-322 HUMAN OTC DRUG Secura Dimethicone Protectant DIMETHICONE CREAM TOPICAL 20050801 20180731 OTC MONOGRAPH FINAL part347 Smith & Nephew, Inc. DIMETHICONE 50 mg/g N 20181231 50484-324_9118b139-bb72-49fa-8a6b-e33ebfc02770 50484-324 HUMAN OTC DRUG Secura Extra Protective ZINC OXIDE CREAM TOPICAL 20030801 20180831 OTC MONOGRAPH FINAL part347 Smith & Nephew, Inc. ZINC OXIDE 306.1 mg/g N 20181231 50484-325_9118b139-bb72-49fa-8a6b-e33ebfc02770 50484-325 HUMAN OTC DRUG Secura Extra Protective ZINC OXIDE CREAM TOPICAL 20030801 20180831 OTC MONOGRAPH FINAL part347 Smith & Nephew, Inc. ZINC OXIDE 306.1 mg/g N 20181231 50484-328_11265aac-a6c8-43b7-a7d8-c85aee51ffc7 50484-328 HUMAN OTC DRUG Secura Antifungal Greaseless MICONAZOLE NITRATE CREAM TOPICAL 20030801 20180630 OTC MONOGRAPH FINAL part333C Smith & Nephew, Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 50484-329_11265aac-a6c8-43b7-a7d8-c85aee51ffc7 50484-329 HUMAN OTC DRUG Secura Antifungal Extra Thick MICONAZOLE NITRATE CREAM TOPICAL 20030801 20180630 OTC MONOGRAPH FINAL part333C Smith & Nephew, Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 50484-341_1c69f85f-2aa6-4fb5-b266-be41d5bee0f2 50484-341 HUMAN OTC DRUG Secura EPC Skin Care Starter Kit ZINC OXIDE,BENZETHONIUM CHLORIDE KIT 20030801 20180730 OTC MONOGRAPH NOT FINAL part347 Smith & Nephew, Inc. N 20181231 50484-344_0cb1b4ad-56c4-4228-a8f2-532d5e6105ea 50484-344 HUMAN OTC DRUG Secura Two Step Kit BENZETHONIUM CHLORIDE AND ZINC OXIDE KIT TOPICAL 20030801 20200131 OTC MONOGRAPH FINAL part347 Smith & Nephew, Inc. N 20181231 50484-490_4d90b12a-3b61-435a-b8e5-9deaa716360d 50484-490 HUMAN OTC DRUG Dermal Wound Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 19910401 20180630 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 ug/mL N 20181231 50484-492_4d90b12a-3b61-435a-b8e5-9deaa716360d 50484-492 HUMAN OTC DRUG Dermal Wound Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 19940401 20180630 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew, Inc. BENZETHONIUM CHLORIDE 1.3 ug/mL N 20181231 50484-810_090ffb2d-8570-4d0b-ac81-c292420c2f2d 50484-810 HUMAN PRESCRIPTION DRUG REGRANEX becaplermin GEL TOPICAL 20111101 BLA BLA103691 SMITH & NEPHEW, INC. BECAPLERMIN 100 ug/g Human Platelet-derived Growth Factor [EPC],Platelet-Derived Growth Factor [Chemical/Ingredient] N 20181231 50485-101_784ef895-d19f-4ab2-a26e-8eab661e4b02 50485-101 HUMAN OTC DRUG Healerz for Noses BENZALKONIUM CHLORIDE and LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333A Wellco Brands LLC BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g N 20181231 50485-102_5fdb1314-c7bc-4543-9fb7-957161bff0ed 50485-102 HUMAN OTC DRUG Healerz for Itches HYDROCORTISONE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part348 Wellco Brands LLC HYDROCORTISONE 1 g/100g N 20181231 50486-221_bec562bb-b81d-4913-a98c-b82844dde61c 50486-221 HUMAN OTC DRUG Encare Nonoxynol-9 INSERT VAGINAL 19990901 OTC MONOGRAPH NOT FINAL part333A Blairex Laboratories, Inc. NONOXYNOL-9 100 mg/1 N 20181231 50486-468_9c1493b9-be1d-448b-a588-00d1d68e19b6 50486-468 HUMAN OTC DRUG Zilactin Early Relief Cold Sore benzyl alcohol GEL TOPICAL 20050630 OTC MONOGRAPH FINAL part346 Blairex Laboratories, Inc. BENZYL ALCOHOL .1 g/g N 20181231 50486-550_a9220e25-13cc-46f1-b213-1e874cf04df5 50486-550 HUMAN OTC DRUG Zilactin-B benzocaine GEL TOPICAL 20050629 OTC MONOGRAPH FINAL part346 Blairex Laboratories, Inc. BENZOCAINE .1 g/g N 20181231 50486-616_005b68f3-4a8e-4c66-bd3a-f32b5815697e 50486-616 HUMAN OTC DRUG Sleepinal diphenhydramine hydrochloride CAPSULE ORAL 19991001 OTC MONOGRAPH FINAL part338 Blairex Laboratories, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 50488-0901_5f114e84-0f7a-d12d-e053-2a91aa0acd7f 50488-0901 HUMAN OTC DRUG Laxacin Docusate sodium and sennosides TABLET ORAL 20111001 20191231 OTC MONOGRAPH NOT FINAL part334 Alexso Inc DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 N 20181231 50488-1001_4d5b9c08-87af-4322-8e02-2703d853caba 50488-1001 HUMAN OTC DRUG Terocin Lidocaine, Menthol PATCH TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Alexso, Inc. LIDOCAINE; MENTHOL, UNSPECIFIED FORM 600; 600 mg/1; mg/1 N 20181231 50488-1129_5dbd5fc0-a27e-4979-aca7-28f73096fd5f 50488-1129 HUMAN OTC DRUG New Terocin Methyl Salicylate, Capsaicin, and Menthol LOTION TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Alexso Inc. METHYL SALICYLATE; CAPSAICIN; MENTHOL 25; .025; 10 g/100mL; g/100mL; g/100mL N 20181231 50488-1201_0e58b6be-5c7d-432a-b33a-7bafbcda2f90 50488-1201 HUMAN OTC DRUG Limencin Lidocaine and Menthol PATCH TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part348 Alexso Inc LIDOCAINE; MENTHOL, UNSPECIFIED FORM 40; 40 mg/1; mg/1 N 20181231 50488-1231_85066887-44d0-4a4a-adee-670073e4b22c 50488-1231 HUMAN OTC DRUG Terocin Methyl Salicylate, Capsaicin, Menthol and Lidocaine Hydrochloride LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part348 Alexso Inc. METHYL SALICYLATE; CAPSAICIN; MENTHOL; LIDOCAINE HYDROCHLORIDE 25; .025; 10; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 50488-1701_e28eafb1-9155-41e6-aa7d-fa1b02e46cd7 50488-1701 HUMAN OTC DRUG MenCaps Capsaicin and Menthol PATCH TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part348 Alexso Inc CAPSAICIN; MENTHOL, UNSPECIFIED FORM .0225; 4.5 g/1; g/1 N 20181231 50488-2626_d4dfc5b4-bdc1-46d4-bf9c-6e35859962ae 50488-2626 HUMAN PRESCRIPTION DRUG Morcin Acontium Napellus CREAM TOPICAL 20140320 UNAPPROVED HOMEOPATHIC Alexso, Inc ACONITUM NAPELLUS; ARNICA MONTANA; BELLADONNA LEAF; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWER; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; COLCHICUM AUTUMNALE FLOWER; HAMAMELIS VIRGINIANA WHOLE; ECHINACEA PURPUREA; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM 6; 6; 6; 6; 5; 6; 4; 6; 6; 6; 6; 6 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL N 20181231 50488-6262_82e07775-1078-432b-8e18-286c40b6d29d 50488-6262 HUMAN OTC DRUG Lidocaine 4% Lidocaine CREAM TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part348 Alexso Inc LIDOCAINE 4 g/100g N 20181231 50491-585_bebff6bf-67b4-4f6a-aab7-f087c79f50b3 50491-585 HUMAN OTC DRUG Instant Foam Hand Sanitizer ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Dixie Packing & Seal Company ALCOHOL .7 mL/mL E 20171231 50491-855_410b1726-9e33-424f-944e-8594e48669f9 50491-855 HUMAN OTC DRUG Instant Foam Hand Sanitizer ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333E Dixie Packing & Seal Company ALCOHOL .62 mL/mL E 20171231 50493-0001_63350c4c-ea72-4fdf-92fc-bfa4188dd0a1 50493-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100118 UNAPPROVED MEDICAL GAS Service Drug OXYGEN 99 L/100L E 20171231 50499-100_ada35464-8cb9-4107-a4c0-822bf7dffeca 50499-100 HUMAN OTC DRUG Dr MINERAL Nasal Spray SODIUM CHLORIDE SPRAY NASAL 20100131 OTC MONOGRAPH FINAL part349 MineralBio SODIUM CHLORIDE .39 mL/60mL E 20171231 50499-200_c490aedc-1254-43dd-a51f-4be89e80dd12 50499-200 HUMAN OTC DRUG Dr MINERAL Anti-Itch Spray SODIUM CHLORIDE SPRAY TOPICAL 20100220 OTC MONOGRAPH FINAL part349 MineralBio SODIUM CHLORIDE; MENTHOL .7; .05 mL/100mL; mL/100mL E 20171231 50499-300_6ed10c93-b0f4-4965-9417-c81bf2be4650 50499-300 HUMAN OTC DRUG Dr MINERAL Anti-Itch SODIUM CHLORIDE SPRAY TOPICAL 20100220 OTC MONOGRAPH FINAL part349 MineralBio SODIUM CHLORIDE; MENTHOL .7; .05 mL/100mL; mL/100mL E 20171231 50503-001_0053785c-5d6d-4d62-a252-03b158ef9dc6 50503-001 HUMAN OTC DRUG Aramis Antiperspirant Aluminum Zirconium Tetra chlorohydrex GLY STICK TOPICAL 20141217 OTC MONOGRAPH FINAL part350 Swallowfield PLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18.6 g/100mL N 20181231 50503-002_2a041ac8-b523-4679-b31f-364361da590f 50503-002 HUMAN OTC DRUG Lab Series Antiperspirant Deodorant Skincare for Men Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20160226 OTC MONOGRAPH FINAL part350 Swallowfield PLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.6 g/100mL N 20181231 50503-003_72ead85d-d072-457f-bb77-33fdddf21f96 50503-003 HUMAN OTC DRUG Clinique For Men Antiperspirant Deodorant Stick aluminum zirconium tetrachlorohydrex gly stick STICK TOPICAL 20160229 OTC MONOGRAPH FINAL part350 Swallowfield PLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.6 g/100g N 20181231 50503-004_82577310-5dcc-4c1a-9356-b7bda6adbf5e 50503-004 HUMAN OTC DRUG Re-Charge Black Pepper Antiperspirant Molton Brown Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101123 OTC MONOGRAPH FINAL part350 Swallowfield PLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 50505-001_d7bac26b-fc14-4f57-bebc-4c96e252b7d2 50505-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19640101 NDA NDA205849 James Supply and Rental Company OXYGEN 99 L/100L N 20181231 50509-100_9b93761d-4ab6-47a0-b8bb-8894639dd9c1 50509-100 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate SOLUTION PARENTERAL 20100722 UNAPPROVED DRUG OTHER Onpharma, Inc. SODIUM BICARBONATE 84 mg/mL E 20171231 50519-221_60c9f9c4-032c-45a3-85db-2239d362ccc5 50519-221 HUMAN OTC DRUG Sani-Gel ALCOHOL GEL TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 American Industrial Supply, Inc. ALCOHOL .7 mL/mL E 20171231 50519-738_440f158e-0626-428e-9ad5-a49265926364 50519-738 HUMAN OTC DRUG Sani Spritz ALCOHOL LIQUID TOPICAL 20091231 OTC MONOGRAPH NOT FINAL part333 American Industrial Supply, Inc. ALCOHOL .7 mL/mL E 20171231 50519-773_73ed2d6c-2168-47c6-81f4-6b5dc0b75335 50519-773 HUMAN OTC DRUG Sani Soft ALCOHOL AEROSOL, FOAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part333 American Industrial Supply, Inc. ALCOHOL 620 mg/g E 20171231 50522-221_c7bf6427-61e9-4fec-b121-e23071010409 50522-221 HUMAN OTC DRUG Sani ALCOHOL GEL TOPICAL 20120524 OTC MONOGRAPH NOT FINAL part333E AIS Specialty Products, Inc. ALCOHOL .7 mL/mL N 20181231 50523-000_9686d3fc-f7ab-4ba1-9c2b-304caeb77e6d 50523-000 HUMAN OTC DRUG DT Ice Cold Analgesic Menthol GEL TOPICAL 20101222 OTC MONOGRAPH FINAL part341 Volume Distributors, Inc. MENTHOL 1 g/100g N 20181231 50523-083_9a9e378d-d51f-4308-be0e-898124f38826 50523-083 HUMAN OTC DRUG Antibacterial Hand Cleanse triclosan SOAP TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part333E Volume Distributors, Inc. TRICLOSAN .15 g/100g E 20171231 50523-084_a678ef92-f3a6-4acc-b4dc-917ae12b4a8c 50523-084 HUMAN OTC DRUG Hand Cleanse Citrus Blast Scent triclosan SOAP TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part333E Volume Distributors, Inc. TRICLOSAN .2 g/100g E 20171231 50523-085_16b17ed2-1190-46d6-b1c6-f0609cd07db8 50523-085 HUMAN OTC DRUG Hand Cleanse Water Melon Scent triclosan SOAP TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part333E Volume Distributors, Inc. TRICLOSAN .2 g/100g E 20171231 50523-086_427b48a4-36da-444d-8bc5-7d3ccfde2632 50523-086 HUMAN OTC DRUG Hand Cleanse Fresh Peach Scent triclosan SOAP TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part333E Volume Distributors, Inc. TRICLOSAN .2 g/100g E 20171231 50523-087_0d1ea536-2af2-4f7d-b43d-51c470b0fe83 50523-087 HUMAN OTC DRUG Ice Cold Analgesic menthol GEL TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part348 Volume Distributors, Inc. MENTHOL 1 g/100g E 20171231 50523-100_5bc72876-5a5a-4e1a-9854-e31cebeac925 50523-100 HUMAN OTC DRUG SPA MYSTIQUE SKIN RELIEF OATMEAL DAILY MOISTURIZING DIMETHICONE LOTION TOPICAL 20120620 OTC MONOGRAPH FINAL part347 Volume Distributors, Inc. DIMETHICONE 13 mg/mL N 20181231 50523-101_696b5c9d-ad61-4b60-b01b-21a566a9a431 50523-101 HUMAN OTC DRUG SPA Mystique Skin Protection Soothing Relief Moisturizing DIMETHICONE CREAM TOPICAL 20130109 OTC MONOGRAPH FINAL part347 Volume Distributors, Inc. DIMETHICONE 13 mg/mL N 20181231 50523-488_aca9ddb6-412d-440b-9c1c-4e2210a97294 50523-488 HUMAN OTC DRUG Silky Smooth Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE CREAM TOPICAL 20110107 OTC MONOGRAPH FINAL part350 VOLUME DISTRIBUTORS ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 50523-489_a4a13d86-7b23-41f4-922d-6d15ce4be2a5 50523-489 HUMAN OTC DRUG Xtreme Stick Anti-Perspirant and Deodorant ALUMINUM CHLOROHYDRATE CREAM TOPICAL 20110107 OTC MONOGRAPH FINAL part350 VOLUME DISTRIBUTORS ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 50523-546_afd2a12b-1062-4577-9911-12ebd30a4d87 50523-546 HUMAN OTC DRUG Bebelle for Kids Antibacterial Hand TRICLOSAN SOAP TOPICAL 20101222 OTC MONOGRAPH NOT FINAL part333E Volume Distributors, Inc. TRICLOSAN .2 g/100mL N 20181231 50523-567_bd4a392f-5a0c-4300-af83-8b4049d57dfc 50523-567 HUMAN OTC DRUG DT ANTIBACTERIAL HAND TRICLOSAN SOAP TOPICAL 20100715 OTC MONOGRAPH NOT FINAL part333E VOLUME DISTRIBUTORS TRICLOSAN 1.5 mg/mL N 20181231 50523-632_1a0d1ba2-c216-415a-9486-813549803baa 50523-632 HUMAN OTC DRUG DT Antibacterial Foaming Hand Wash TRICLOSAN LIQUID TOPICAL 20101222 OTC MONOGRAPH NOT FINAL part333E Volume Distributors, Inc. TRICLOSAN .15 mL/100mL N 20181231 50523-739_7f1c6ad7-9db0-4274-aa74-4e9efbdfa128 50523-739 HUMAN OTC DRUG DT Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110722 OTC MONOGRAPH FINAL part355 Volume Distributors, Inc. SODIUM MONOFLUOROPHOSPHATE .1 g/100g E 20171231 50523-740_f6be5d77-dcbc-458b-a4d0-f971d5fbe7d6 50523-740 HUMAN OTC DRUG DT Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110722 OTC MONOGRAPH FINAL part355 Volume Distributors, Inc. SODIUM MONOFLUOROPHOSPHATE .1 g/100g E 20171231 50532-066_bc736980-23b1-11e2-b904-0002a5d5c51b 50532-066 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine SUSPENSION RECTAL 20100401 NDA AUTHORIZED GENERIC NDA019618 Franklin Pharmaceutical LLC MESALAMINE 4 g/60mL Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 50532-112_f2608534-332a-46af-98f1-87fa47226492 50532-112 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate HYOSCYAMINE SULFATE TABLET ORAL 20100501 UNAPPROVED DRUG OTHER Franklin Pharmaceutical LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 50532-113_02ab3cb8-eac0-4bf9-9c25-5ed1173bab93 50532-113 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate SL HYOSCYAMINE SULFATE TABLET, SOLUBLE ORAL 20100501 UNAPPROVED DRUG OTHER Franklin Pharmaceutical LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 50532-115_5ae1ed10-3ec3-4a6d-bf30-7b8085d37757 50532-115 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate HYOSCYAMINE SULFATE TABLET ORAL 20100501 UNAPPROVED DRUG OTHER Franklin Pharmaceutical LLC HYOSCYAMINE SULFATE .375 mg/1 N 20181231 50536-039_9b886300-68c0-4832-86ed-517d2e731029 50536-039 HUMAN OTC DRUG SANIFOAM HAND SANITIZER ALCOHOL LOTION TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY INC ALCOHOL 62 mL/100mL N 20181231 50536-077_185d3235-1886-41d9-8e0f-1dcb0fa2652e 50536-077 HUMAN OTC DRUG PREVENT HAND SANITIZER ALCOHOL GEL TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY INC ALCOHOL 62 mL/100mL N 20181231 50536-078_b33c9a99-0e81-4793-8d07-2f8593e9d8bc 50536-078 HUMAN OTC DRUG SANIFOAM HAND SANITIZER ALCOHOL GEL TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY INC ALCOHOL 62 mL/100mL N 20181231 50536-101_0cfae509-e730-4604-9eae-52a6871349b7 50536-101 HUMAN OTC DRUG SUPER SUDS ANTI-BACTERIAL ALCOHOL SOAP TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY INC ALCOHOL 62 mL/100mL N 20181231 50536-102_c63b6d76-fb9e-4c71-83af-0cd2311006fc 50536-102 HUMAN OTC DRUG T-CHEM ANTIMICROBIAL HAND ALCOHOL SOAP TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY INC ALCOHOL 62 mL/100mL N 20181231 50536-192_b43f9b02-f843-4949-b93d-05adf9006e9e 50536-192 HUMAN OTC DRUG T-Chem E2 Rated CHLOROXYLENOL, TRICLOSAN SOAP TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A AMERICAN CHEMICAL AND SANITARY SUPPLY INC CHLOROXYLENOL; TRICLOSAN .45; .06 g/100mL; 1/100mL N 20181231 50538-001_3f8653ea-0f28-41ae-bdb7-9bb718361f49 50538-001 HUMAN OTC DRUG All-Natural Pen Spray Silver Citrate AEROSOL, SPRAY TOPICAL 20100209 OTC MONOGRAPH NOT FINAL part333 HANGZHOU KARIC COMMODITIES CO., LTD. SILVER CITRATE; ANHYDROUS CITRIC ACID .15; .15 g/100g; g/100g E 20171231 50539-221_32cc712f-dc81-4e98-945b-c57f47c9d77c 50539-221 HUMAN OTC DRUG Pure Hands ALCOHOL GEL TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Buck Head Products & Systems ALCOHOL .7 mL/mL E 20171231 50544-001_038390ce-8684-4c27-98dc-9521d0e3964b 50544-001 HUMAN OTC DRUG Oil-Free Acne Cleanser Benzoyl Peroxide CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part333D University Medical Pharmaceuticals Corp BENZOYL PEROXIDE 2.5 g/100g E 20171231 50544-004_f3aa84cc-d4dd-4fe2-96d2-90a6a4052e6d 50544-004 HUMAN OTC DRUG Therapeutic Sulfur Mask Sulfur CREAM TOPICAL 20110906 OTC MONOGRAPH FINAL part333D University Medical Pharmaceuticals Corp SULFUR 35 g/1000g E 20171231 50544-100_56a897db-8b8f-4c86-92ec-dceaa84f3810 50544-100 HUMAN OTC DRUG AcneFree Severe Antibacterial Cleansing Wash Benzoyl Peroxide CREAM TOPICAL 20111221 OTC MONOGRAPH FINAL part333D University Medical Pharmaceuticals Corp BENZOYL PEROXIDE 2.5 mL/100mL E 20171231 50544-101_56a897db-8b8f-4c86-92ec-dceaa84f3810 50544-101 HUMAN OTC DRUG AcneFree Severe Maximum Strength Repair Lotion Benzoyl Peroxide LOTION TOPICAL 20111220 OTC MONOGRAPH FINAL part333D University Medical Pharmaceuticals Corp BENZOYL PEROXIDE 10 mL/100mL E 20171231 50544-301_dbf02fdc-bab0-4fab-a9ba-d92cfd134704 50544-301 HUMAN OTC DRUG AF Foam Clear Skin Acne Pore Cleanser Benzoyl Peroxide AEROSOL, FOAM TOPICAL 20111101 OTC MONOGRAPH FINAL part333D University Medical Pharmaceuticals Corp BENZOYL PEROXIDE 2.5 g/100g E 20171231 50544-304_a5c8f9f0-a6cd-4163-99ad-db2ba00fbd92 50544-304 HUMAN OTC DRUG AF Foam Sensitive Acne Pore Cleanser Salicylic Acid AEROSOL, FOAM TOPICAL 20111115 OTC MONOGRAPH FINAL part333D University Medical Pharmaceuticals Corp SALICYLIC ACID 1.5 g/100g E 20171231 50552-001_5d865601-206a-449d-88fe-feebb7d8a1fa 50552-001 HUMAN OTC DRUG Anti-Bacterial Wipes BENZALKONIUM CHLORIDE CLOTH TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part333 Tongling Jieya Biological Technology Co., Ltd. BENZALKONIUM CHLORIDE .155 1/1001 N 20181231 50554-002_58d4d5ad-b238-47c3-8a54-a1db9060ba46 50554-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20140101 NDA NDA205850 DuPuy Oxygen & Supply Company, Inc. NITROGEN 990 mL/L N 20181231 50554-005_83ab3943-952e-4d78-8b63-6841966cffc7 50554-005 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19540101 NDA NDA206009 DuPuy Oxygen & Supply Company, Inc. NITROUS OXIDE 990 mL/L N 20181231 50554-007_e5dc9443-8ba3-4819-a103-45226091facb 50554-007 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20140113 NDA NDA205826 DuPuy Oxygen & Supply Company, Inc. AIR 1000 mL/L N 20181231 50554-100_ab9301ec-cbec-4d01-b0b5-d91aeac07fe5 50554-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140101 NDA NDA205849 DuPuy Oxygen & Supply Company, Inc. OXYGEN 990 mL/L N 20181231 50555-010_97989b50-745d-4dc6-8ad0-b988de7daab7 50555-010 HUMAN OTC DRUG Pororo Toothpas te Melon Sodium Monofluorophosphate PASTE, DENTIFRICE TOPICAL 20160801 OTC MONOGRAPH FINAL part355 KMPHARMACEUTICAL CO.,LTD SODIUM MONOFLUOROPHOSPHATE .31 g/90g N 20181231 50555-020_338a4b06-7b94-4014-ae58-f32068a314f8 50555-020 HUMAN OTC DRUG Pororo Toothpas te Apple Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20160801 OTC MONOGRAPH FINAL part355 KMPHARMACEUTICAL CO.,LTD SODIUM MONOFLUOROPHOSPHATE .31 g/90g N 20181231 50555-030_25a47ee8-a17f-46c4-b2e1-91014b22a36f 50555-030 HUMAN OTC DRUG Pororo Toothpas te Pineapple Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20160801 OTC MONOGRAPH FINAL part355 KMPHARMACEUTICAL CO.,LTD SODIUM MONOFLUOROPHOSPHATE .31 g/90g N 20181231 50555-040_2fbdf954-7684-42eb-b081-945612af9e63 50555-040 HUMAN OTC DRUG Pororo Toothpas te Mixed Fruits Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20160801 OTC MONOGRAPH FINAL part355 KMPHARMACEUTICAL CO.,LTD SODIUM MONOFLUOROPHOSPHATE .31 g/90g N 20181231 50556-001_9ebea00c-ffd4-47cb-afb8-189b0e1ba705 50556-001 HUMAN OTC DRUG SUPER BB ANTI WRINKLE AND SUN PROTECTION SPF36 TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 UNHWA CORPORATION TITANIUM DIOXIDE 1.6 mL/30mL E 20171231 50556-003_c3ab1ffd-4767-477b-9cbd-4773813d7683 50556-003 HUMAN OTC DRUG SUPER SERUM ANTI AGING AND FIRMING DIMETHICONE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part347 UNHWA CORPORATION DIMETHICONE .7 mL/35mL E 20171231 50556-004_67322f6b-875a-4019-828f-6b87391c46d7 50556-004 HUMAN OTC DRUG SUPER CREAM AGE CONTROL AND FIRMING DIMETHICONE CREAM CUTANEOUS 20091001 OTC MONOGRAPH FINAL part347 UNHWA CORPORATION DIMETHICONE .58 mL/45mL E 20171231 50558-001_48eed65c-3411-47f9-9c3a-8dcc84c2ce23 50558-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960401 UNAPPROVED MEDICAL GAS BGR Enterprises, Inc. dba Penn Oxygen & Supply Company OXYGEN 995 mL/L E 20171231 50558-002_48eed65c-3411-47f9-9c3a-8dcc84c2ce23 50558-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 19960401 UNAPPROVED MEDICAL GAS BGR Enterprises, Inc. dba Penn Oxygen & Supply Company OXYGEN 995 mL/L E 20171231 50562-001_285f3b46-1b67-4cfd-a797-78974fe858a9 50562-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20090601 NDA NDA205767 Alliance Welding Supplies, Inc. OXYGEN 992 mL/L N 20181231 50562-002_65e3cdd5-62c5-4332-b178-9b89a6752fb1 50562-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20100601 NDA NDA205766 Alliance Welding Supplies, Inc. NITROGEN 992 mL/L N 20181231 50563-101_33adff8a-5eec-4d4c-91c1-b1f8cca9fa8d 50563-101 HUMAN OTC DRUG Enchanted Moments Berries and Cream Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110607 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g E 20171231 50563-102_dd4541b9-6b31-41d0-a1f4-760b23b69773 50563-102 HUMAN OTC DRUG Enchanted Moments Candy Apple Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110629 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g E 20171231 50563-103_04f873b8-31b2-4ca5-94fc-d86f33a0b858 50563-103 HUMAN OTC DRUG Enchanted Moments Mistletoe Kisses Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g E 20171231 50563-104_8401bbfe-a58f-49e6-8bbd-74e756818af0 50563-104 HUMAN OTC DRUG Enchanted Moments Vanilla Snow Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g E 20171231 50563-105_be0e79a2-a13e-40a5-bcaf-efbf55184c12 50563-105 HUMAN OTC DRUG Body Luxuries Fresh Cotton Hand Sanitizer ALCOHOL LIQUID TOPICAL 20111007 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g E 20171231 50563-106_b705dbc3-7ee4-4760-949d-e02c36dcbf0c 50563-106 HUMAN OTC DRUG Body Luxuries Sweet Lavender Hand Sanitizer ALCOHOL LIQUID TOPICAL 20111007 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g E 20171231 50563-107_10f33869-ab1c-4408-9302-9223998b5ab9 50563-107 HUMAN OTC DRUG Bella Maison Tropical Vanilla Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g E 20171231 50563-108_240fb7e3-d96f-49ae-baab-c1da05154e6f 50563-108 HUMAN OTC DRUG Bella Maison Coconut Pineapple Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 g/100g E 20171231 50563-109_2701c8d9-18f8-4014-9144-40233a4b8c53 50563-109 HUMAN OTC DRUG Ocean Mist Scented Hand Sanitizer Anti-Bacterial BENZETHONIUM CHLORIDE LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. BENZETHONIUM CHLORIDE .13 g/100mL E 20171231 50563-110_fcec2e97-45d1-4c3d-8f8d-a1993574bc5f 50563-110 HUMAN OTC DRUG Peach Sensation Scented Hand Sanitizer Anti-Bacterial BENZETHONIUM CHLORIDE LIQUID TOPICAL 20120628 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. BENZETHONIUM CHLORIDE .13 g/100mL E 20171231 50563-111_5b50d462-2d19-47e1-9cb0-b04c127d2310 50563-111 HUMAN OTC DRUG Magnolia Blossom Scented Hand Sanitizer Anti-Bacterial BENZETHONIUM CHLORIDE LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. BENZETHONIUM CHLORIDE .13 g/100mL E 20171231 50563-112_792b050f-8c64-4d68-9646-f7bbab86311e 50563-112 HUMAN OTC DRUG Pink Grapefruit Scented Hand Sanitizer Anti-Bacterial BENZETHONIUM CHLORIDE LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. BENZETHONIUM CHLORIDE .13 g/100mL E 20171231 50563-113_838a9bbf-ef6e-44cc-ab60-37a2a27d7c85 50563-113 HUMAN OTC DRUG April Bath and Shower Cucumber Melon Scented Hand Sanitizer Anti-Bacterial CHLOROXYLENOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. CHLOROXYLENOL .5 g/100mL E 20171231 50563-114_b0a1cbfc-b1b1-4425-946e-db4f7c321f11 50563-114 HUMAN OTC DRUG April Bath and Shower Sweet Blossom Scented Hand Sanitizer Anti-Bacterial CHLOROXYLENOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. CHLOROXYLENOL .5 g/100mL E 20171231 50563-115_ce229c80-8b32-4497-962a-be10ccc21813 50563-115 HUMAN OTC DRUG April Bath and Shower Warm Vanilla Scented Hand Sanitizer Anti-Bacterial CHLOROXYLENOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. CHLOROXYLENOL .5 g/100mL E 20171231 50563-116_9ea688d7-280f-4660-a8b5-9917a5ce03dc 50563-116 HUMAN OTC DRUG Body Luxuries French Lavender Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-117_aa569442-12a2-4e15-9f0c-fb5e924cd37d 50563-117 HUMAN OTC DRUG Body Luxuries Coconut Vanilla Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-118_359248fb-5522-451e-b114-a83b401dd7fb 50563-118 HUMAN OTC DRUG Body Luxuries Cherry Blossom Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120630 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-119_77903bd5-39a3-4d89-8580-a37fb2589302 50563-119 HUMAN OTC DRUG Body Luxuries Pineapple Mango Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120628 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-120_afa135c1-536b-4e6a-a5db-fef3ed676c48 50563-120 HUMAN OTC DRUG Raymond Waites Gerber Daisy Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120908 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-121_6f866143-d79e-4787-89a4-453a7024e41f 50563-121 HUMAN OTC DRUG Raymond Waites Gerber Daisy Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120908 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-122_69e8b844-afd8-4576-91e2-f3ddf5daea46 50563-122 HUMAN OTC DRUG Raymond Waites Honeysuckle Rose Waterless Anti-bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120908 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-123_96210b7e-2bdb-4721-ba50-144c3c07ea96 50563-123 HUMAN OTC DRUG Susan Winget Berries and Cream Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121208 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-124_fc473a22-d3d7-41a6-bc75-ccdcf887373e 50563-124 HUMAN OTC DRUG Susan Winget Mango Orange Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-125_40a5a072-2d6e-43a9-9221-e524106d7dd6 50563-125 HUMAN OTC DRUG Body Luxuries Moroccan Rose Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-126_8a31dd1d-1ba6-47f9-80ad-cd0ae31de208 50563-126 HUMAN OTC DRUG Body Luxuries French Lavender Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-127_157080f3-9a0c-402a-b49d-a0278ab70557 50563-127 HUMAN OTC DRUG Body Luxuries Tihitian Vanilla Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-128_b7cd7b1c-77de-494f-95fa-e920de64ab19 50563-128 HUMAN OTC DRUG Body Luxuries English Pear Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-129_cb394321-7ac5-43fb-b89c-858644249bb1 50563-129 HUMAN OTC DRUG Charlie girl Blueberry Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130509 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-130_6f2629ce-03c9-40bb-935d-1ecc9745dfd3 50563-130 HUMAN OTC DRUG Charlie girl Strawberry Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130509 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-131_b16e858c-b9d0-4670-b73b-6b6623455cf9 50563-131 HUMAN OTC DRUG Charlie girl Grape Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130509 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-132_97afeb31-646f-4f88-9ae9-0c8b6370d43d 50563-132 HUMAN OTC DRUG RUE21 Doughnut Sprinkles Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-133_9b122791-1029-4de7-bf53-0b9449596f2e 50563-133 HUMAN OTC DRUG RUE21 Midnight Musk Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-134_67b64c4e-0885-4950-9142-4304241021ac 50563-134 HUMAN OTC DRUG RUE21 Cotton Candy Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-135_b22e572f-0620-4ca8-86bc-eacbc92b10ab 50563-135 HUMAN OTC DRUG RUE21 Sugar Cookie Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-136_09b1fc0f-b422-4fcd-862b-32d7795765fe 50563-136 HUMAN OTC DRUG RUE21 Vanilla Spice Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-137_2d730cff-4674-40e2-8bed-36e19f7b0dd6 50563-137 HUMAN OTC DRUG RUE21 Cherry Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-138_daf30076-785d-47e3-91be-d64f6b8c815e 50563-138 HUMAN OTC DRUG RUE21 Apple Spice Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-139_63b40786-ea37-49fb-8d61-0d995b021d83 50563-139 HUMAN OTC DRUG RUE21 Ocean Breeze Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-140_2d276c45-839e-440a-ac0f-0e04bfaff19e 50563-140 HUMAN OTC DRUG RUE21 Strawberry Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-141_7a23e1a7-9722-487b-8249-e61ecc78269e 50563-141 HUMAN OTC DRUG RUE21 Peppermint Twist Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-142_18d86058-6e4c-4ac1-85d8-ede966129046 50563-142 HUMAN OTC DRUG RUE21 Cherry Blossom Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-143_6dae7eaa-24b3-4dfb-bc0a-c83abc8223fb 50563-143 HUMAN OTC DRUG RUE21 Runway 21 Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-144_c87734fc-5a80-4a4d-8cd5-90616095ce6c 50563-144 HUMAN OTC DRUG RUE21 Posh Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-145_8f41b5c8-ee91-41c8-b7dd-d950a7a13182 50563-145 HUMAN OTC DRUG Body Luxuries Lotus Flower Scented Waterless Anti Bacterial Hand gel ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-146_90f2996d-c334-4259-b7e7-334ed12bb857 50563-146 HUMAN OTC DRUG Body Luxuries Dahlia Blossom Scented Waterless Anti Bacterial Hand gel ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-147_a0f0a234-9610-491b-89bb-c1d5224aa389 50563-147 HUMAN OTC DRUG Body Luxuries Strawberry Scented Waterless Anti Bacterial Hand gel ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-148_e469255a-b993-485b-a618-26ed4b9f8d49 50563-148 HUMAN OTC DRUG Body Luxuries Blueberry Scented Waterless Anti Bacterial Hand gel ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-149_68b9ee12-304d-4faa-8638-588049875cf3 50563-149 HUMAN OTC DRUG Body Luxuries French Lavender Scented Waterless Anti Bacterial Hand gel ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-150_551712e8-2f48-4772-909f-c23f7590d4ad 50563-150 HUMAN OTC DRUG Raspberry Vanilla Scented Waterless Hand Sanitizer ALCOHOL GEL TOPICAL 20100222 OTC MONOGRAPH FINAL part333 Enchante Accessories, Inc ALCOHOL 62 mL/100mL E 20171231 50563-151_a9c00d06-5f7f-4dfb-83d0-9a86bfb4938c 50563-151 HUMAN OTC DRUG Healing Waters Cucumber Melon Scented Waterless Hand Sanitizer ALCOHOL GEL TOPICAL 20100222 OTC MONOGRAPH FINAL part333 Enchante Accessories, Inc ALCOHOL 62 mL/100mL E 20171231 50563-152_911214a6-48a9-4629-86f0-f4a59328d5a3 50563-152 HUMAN OTC DRUG Healing Waters Cherry Blossom Scented Waterless Hand Sanitizer ALCOHOL GEL TOPICAL 20100222 OTC MONOGRAPH FINAL part333 Enchante Accessories, Inc ALCOHOL 62 mL/100mL E 20171231 50563-153_9a4d91be-8209-4b2a-96f8-fd33d6291f7c 50563-153 HUMAN OTC DRUG Body Luxuries Waterless Hand Sanitizer Ethyl Alcolhol LIQUID TOPICAL 20100621 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL E 20171231 50563-154_402e84ca-af1a-4fe8-bee7-ece7db01c9d7 50563-154 HUMAN OTC DRUG Body Raves Antibacterial Hand Sanitizer - Wild Strawberry Ethyl Alcohol LIQUID TOPICAL 20100621 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL E 20171231 50563-155_de57563b-3bda-4b2e-ae5e-1ac100147c1c 50563-155 HUMAN OTC DRUG Body Raves Antibacterial Hand Sanitizer - Lavender Vanilla Ethyl Alcohol LIQUID TOPICAL 20100621 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL E 20171231 50563-160_de930654-8a5d-4e90-81d7-0ace313c0a1b 50563-160 HUMAN OTC DRUG Body Luxuries English Pear Scented Waterless Anti Bacterial Hand gel ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-161_576a9300-a353-40f6-aef4-c321ee96a9af 50563-161 HUMAN OTC DRUG Just 4 Girl Waterless Anti Bacterial Hand Sanitizer Berry Blast ALCOHOL LIQUID TOPICAL 20130709 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-162_848a678c-ab24-48ee-b54e-a86468269025 50563-162 HUMAN OTC DRUG RUE 21 Fallen Vixen Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-163_56b570f2-c3f6-49b9-8a25-627c9fd0bd6b 50563-163 HUMAN OTC DRUG RUE 21 Legend Blueberry Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-164_6f812a79-33f2-43dc-a8a8-4d502c89b353 50563-164 HUMAN OTC DRUG RUE 21 Free Spirit Fresh Flowers Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-165_ed43b469-06e3-4528-b1e5-59cd7077a775 50563-165 HUMAN OTC DRUG RUE 21 Young Strawberry Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-166_18d39064-fdc3-4a48-b9f9-5311e4a54ebd 50563-166 HUMAN OTC DRUG RUE 21 Queen Cherry Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-167_3b45d5e8-53ad-4a51-8ced-1e4021d819da 50563-167 HUMAN OTC DRUG RUE 21 Love Cherry Blossom Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-168_ab6a163d-3e81-40d6-81a8-db4c644bb4df 50563-168 HUMAN OTC DRUG RUE 21 Apple Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-169_e82c6b01-0e3e-4d50-8f6b-1914c32b58c2 50563-169 HUMAN OTC DRUG RUE 21 Sugar Cookie Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-170_f0302b56-f418-465a-acdb-e11181672f6e 50563-170 HUMAN OTC DRUG RUE 21 Dream Dance Love Vanilla Spice Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-171_14587702-10bf-4e99-bca4-07b6dc1e55e4 50563-171 HUMAN OTC DRUG RUE 21 Paris Creamsicle Anti Bacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20131109 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 63 mL/100mL E 20171231 50563-176_465c7f67-1013-4539-bd2c-609b0a9944b6 50563-176 HUMAN OTC DRUG Jelly Bean Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-177_08a019c8-abf0-425d-a3f6-2b7e085c78b7 50563-177 HUMAN OTC DRUG Vanilla Sugar Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-178_5e3e924c-99c0-4589-a4a5-05dc8e2343f2 50563-178 HUMAN OTC DRUG Angel Foodcake Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-179_baf91ee4-aa99-4968-a5d2-72ecedfbcc07 50563-179 HUMAN OTC DRUG Pink Macaroon Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-180_f11cfab1-b052-4724-8d0e-faadd3678990 50563-180 HUMAN OTC DRUG Cotton Candy Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-181_11f34eb6-f4ef-47c0-89be-cdc40f8fe45b 50563-181 HUMAN OTC DRUG Passion Fruit Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-182_e27532f1-a40a-496e-93d7-eb45f13cb876 50563-182 HUMAN OTC DRUG Green Apple Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-183_e47f6114-6cf9-4a4e-ab86-cc33f0abde0e 50563-183 HUMAN OTC DRUG Blue Rasberry Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-184_5029ed1a-b53f-4f5d-9973-3d987bb794ca 50563-184 HUMAN OTC DRUG Creamsicle Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-185_da5165d4-aa86-4135-b1d5-7e07d3f60366 50563-185 HUMAN OTC DRUG Creamsicle Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-186_55d866bf-b255-4730-8162-9bc271ef3d44 50563-186 HUMAN OTC DRUG Pink Lemonade Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141002 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-191_3a3a41cb-7142-661f-e054-00144ff88e88 50563-191 HUMAN OTC DRUG Holiday Wonders Frosted Marshmallow Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20160815 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-192_3a3bce42-d9c0-1380-e054-00144ff88e88 50563-192 HUMAN OTC DRUG Holiday Wonders Vanilla Peppermint Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20160815 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-193_3a3bce42-d9cc-1380-e054-00144ff88e88 50563-193 HUMAN OTC DRUG Holiday Wonders Sugared Plums Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20160815 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-194_3a3bd4e2-a686-0652-e054-00144ff8d46c 50563-194 HUMAN OTC DRUG Holiday Wonders Winter Berries Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20160815 OTC MONOGRAPH NOT FINAL part333E ENCHANTE ACCESSORIES INC. ALCOHOL 62 mL/100mL E 20171231 50563-200_4fccfc18-002d-4ef9-adae-26522d91adac 50563-200 HUMAN OTC DRUG Cranberry Vanilla Scented Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL E 20171231 50563-201_59d88bcc-585c-434d-8ce9-1d21df71115a 50563-201 HUMAN OTC DRUG Sugar Cookies Scented Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL E 20171231 50563-202_951d908e-7cec-4e0d-a639-997193a2006a 50563-202 HUMAN OTC DRUG Jingle Berry Scented Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL E 20171231 50563-204_3e078a40-c0bb-4dce-9c6e-cc1ec9b5df6d 50563-204 HUMAN OTC DRUG Orange Spice Scented Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL E 20171231 50563-300_dec06938-8de5-404b-b00a-9f2a0c8c7a97 50563-300 HUMAN OTC DRUG Vanilla Mint Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL E 20171231 50563-301_558e39ad-4eb2-4494-8f96-4d169b15bf7b 50563-301 HUMAN OTC DRUG Sugared Pear Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL E 20171231 50563-302_63861145-29a5-4afc-ae1a-d4b4dc88c3a9 50563-302 HUMAN OTC DRUG Vanilla Cupcake Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL E 20171231 50563-303_0563acc8-bcbd-4b2c-a92e-e8b4fd53b929 50563-303 HUMAN OTC DRUG Peppermint Swirl Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20100707 OTC MONOGRAPH FINAL part333 Enchante Accessories ALCOHOL 62 mL/100mL E 20171231 50563-400_bfc49ce8-6eb7-47b8-bfaa-410b2e6fb4e4 50563-400 HUMAN OTC DRUG Aromafields Plumeria Scented Antibacterial Hand Wash TRICLOSAN LIQUID TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Enchante Accessories TRICLOSAN .025 mL/100mL E 20171231 50563-401_774dd919-b528-45ab-b3ef-48815b949a96 50563-401 HUMAN OTC DRUG Aromafields Tiger Lily Scented Antibacterial Hand Wash TRICLOSAN LIQUID TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Enchante Accessories TRICLOSAN .025 mL/100mL E 20171231 50563-402_cffdcb82-467e-4461-8d26-b626b0baf923 50563-402 HUMAN OTC DRUG Aromafields Jasmine Scented Antibacterial Hand Wash TRICLOSAN LIQUID TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Enchante Accessories TRICLOSAN .025 mL/100mL E 20171231 50563-403_84c0aeff-4798-47d1-8aac-4d40d5b96404 50563-403 HUMAN OTC DRUG Aromafields Lavender Scented Antibacterial Hand Wash TRICLOSAN LIQUID TOPICAL 20100707 OTC MONOGRAPH NOT FINAL part333 Enchante Accessories TRICLOSAN .025 mL/100mL E 20171231 50563-500_b14f78b9-58e0-450f-93ca-1c0e6a2f6dd1 50563-500 HUMAN OTC DRUG body luxuries Vanilla Frosting Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100120 OTC MONOGRAPH FINAL part333E Enchante Accessories, Inc. ALCOHOL 62 mL/100mL E 20171231 50563-501_ce4ba711-aee3-4dcf-823f-0ca39b7f06e7 50563-501 HUMAN OTC DRUG body luxuries Strawberry Shortcake Antibacterial Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100120 OTC MONOGRAPH FINAL part333E Enchante Accessories, Inc. ALCOHOL 62 mL/100mL E 20171231 50564-544_62529440-d079-4a5a-abd0-ef1134895b7b 50564-544 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Jerome Stevens Pharmaceuticals, Inc. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 50564-545_62529440-d079-4a5a-abd0-ef1134895b7b 50564-545 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Jerome Stevens Pharmaceuticals, Inc. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 50573-3550_dd921222-b1fa-495a-8883-e657dd77b050 50573-3550 HUMAN OTC DRUG Diaper Rash Skin Protectant Crema Cero ZINC OXIDE CREAM TOPICAL 20100224 OTC MONOGRAPH FINAL part347 Laboratorios Cero S.A. ZINC OXIDE 4.9 g/100g N 20181231 50573-3560_11192570-eef5-43d5-9c24-68473fe2c049 50573-3560 HUMAN OTC DRUG Diaper Rash Skin Protectant Crema Cero With Aloe Vera ZINC OXIDE CREAM TOPICAL 20110526 OTC MONOGRAPH FINAL part347 Laboratorios Cero S.A. ZINC OXIDE 4.9 g/100g N 20181231 50577-0001_ca7c81ad-3466-4678-b7d1-657c7397e7fe 50577-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100119 UNAPPROVED MEDICAL GAS Horn's Medical Supply, Inc. OXYGEN 99 L/100L E 20171231 50580-070_3e39b5e3-d0de-4d0d-93a5-071198551c0e 50580-070 HUMAN PRESCRIPTION DRUG VERMOX mebendazole TABLET, CHEWABLE ORAL 19750114 NDA NDA017481 Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Division MEBENDAZOLE 100 mg/1 Antihelminthic [EPC] N 20181231 50580-100_a6fed46c-5c77-4a38-a904-7bd902946949 50580-100 HUMAN OTC DRUG Infants Motrin Ibuprofen SUSPENSION/ DROPS ORAL 20040601 NDA NDA020603 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division IBUPROFEN 50 mg/1.25mL N 20181231 50580-110_e36d9511-fcec-4de0-bbe7-81a89c4bd9a5 50580-110 HUMAN OTC DRUG Motrin IB Ibuprofen TABLET, FILM COATED ORAL 20000801 NDA NDA019012 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division IBUPROFEN 200 mg/1 N 20181231 50580-123_7fe66c12-211e-4627-8747-8bacd83b25bf 50580-123 HUMAN OTC DRUG Childrens TYLENOL acetaminophen SUSPENSION ORAL 20111101 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-134_ea7c07ee-efee-4e5a-ab03-19a8021e3588 50580-134 HUMAN OTC DRUG Imodium A-D Loperamide Hydrochloride SOLUTION ORAL 20040701 NDA NDA019487 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 50580-164_c85f98f3-f122-44f8-bc85-470716f33822 50580-164 HUMAN OTC DRUG Childrens TYLENOL acetaminophen SUSPENSION ORAL 20140601 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-170_a1544fa0-d956-468b-9785-9eba0b97435e 50580-170 HUMAN OTC DRUG Childrens TYLENOL Acetaminophen SUSPENSION ORAL 20170116 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-184_b6eecd17-36d3-4533-83e3-26f2cf841e5b 50580-184 HUMAN OTC DRUG Childrens Motrin Ibuprofen SUSPENSION ORAL 20010901 NDA NDA020516 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division IBUPROFEN 100 mg/5mL N 20181231 50580-191_cbfc00e4-66ee-4577-be27-cd2da45a0eb8 50580-191 HUMAN OTC DRUG Infants TYLENOL acetaminophen SUSPENSION ORAL 20130501 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-194_5ce15358-3109-4722-8c14-2ef1526756c5 50580-194 HUMAN OTC DRUG Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT Acetaminophen and Dextromethorphan Hydrobromide SUSPENSION ORAL 20170626 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL N 20181231 50580-198_45134687-4a87-4dd9-b5f4-e4e461cc68ae 50580-198 HUMAN OTC DRUG Motrin Infants Ibuprofen SUSPENSION/ DROPS ORAL 20010901 NDA NDA020603 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division IBUPROFEN 50 mg/1.25mL N 20181231 50580-223_ff802956-d69c-4e31-8e6f-2bf3623b7fd4 50580-223 HUMAN OTC DRUG Infants TYLENOL acetaminophen SUSPENSION ORAL 20130510 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-226_fe847ac8-40fb-4a7a-be13-9e02ce3d8b61 50580-226 HUMAN OTC DRUG Benadryl Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20080901 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50580-228_93865c14-e5b7-4658-abb1-8058e7d0ffda 50580-228 HUMAN OTC DRUG Benadryl Allergy Liqui-Gels diphenhydramine hydrochloride CAPSULE, LIQUID FILLED ORAL 20090301 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50580-230_09082bbf-b8cd-4f87-8b39-fbef48c864ec 50580-230 HUMAN OTC DRUG Motrin IB Ibuprofen TABLET, FILM COATED ORAL 20160701 ANDA ANDA077349 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division IBUPROFEN 200 mg/1 N 20181231 50580-232_0799ace5-53b7-4264-93a4-35ff0c4534ae 50580-232 HUMAN OTC DRUG Childrens Benadryl Chewables diphenhydramine hydrochloride TABLET, CHEWABLE ORAL 20160711 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20181231 50580-241_c89c0d17-d135-4049-8233-17f9b0aae87c 50580-241 HUMAN OTC DRUG Tylenol Cold plus Flu Severe and Tylenol Cold Max Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, and Phenylephrine Hydrochloride KIT 20161003 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division N 20181231 50580-245_290e8323-2ae1-498d-9984-ccd2252a93a7 50580-245 HUMAN OTC DRUG Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE Acetaminophen, Chlorpheniramine Maleate, and Dextromethorphan Hydrobromide SUSPENSION ORAL 20170626 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 50580-296_fd040f2e-4af7-4150-951b-9003bbdf1c7e 50580-296 HUMAN OTC DRUG Childrens TYLENOL Acetaminophen SUSPENSION ORAL 20040701 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-299_a358bcd5-c4f6-40fa-b552-49bd4a2fd7e7 50580-299 HUMAN OTC DRUG Childrens TYLENOL COLD Plus FLU Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride SUSPENSION ORAL 20170626 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 50580-309_dd84834f-a942-4d82-b39b-d6dfea591afb 50580-309 HUMAN OTC DRUG Tylenol 8HR acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160118 NDA NDA019872 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 650 mg/1 N 20181231 50580-317_9e3f4489-c557-4b87-8ceb-83d65e3a13e9 50580-317 HUMAN OTC DRUG Imodium A-D Loperamide hydrochloride TABLET, FILM COATED ORAL 20150713 ANDA ANDA075232 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 50580-325_aa8baf93-80a6-45d5-86c1-62636425441e 50580-325 HUMAN OTC DRUG Infants TYLENOL Acetaminophen SUSPENSION ORAL 20170925 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-338_bb6e86bb-fee4-45b1-ab6b-d9206998f362 50580-338 HUMAN OTC DRUG IMODIUM Multi-Symptom Relief loperamide hydrochloride and dimethicone TABLET ORAL 20080701 NDA NDA021140 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division LOPERAMIDE HYDROCHLORIDE; DIMETHICONE 2; 125 mg/1; mg/1 N 20181231 50580-341_b3cab5d8-f759-4236-97c5-08a91b2152d4 50580-341 HUMAN OTC DRUG Childrens Benadryl Allergy Plus Congestion Diphenhydramine hydrochloride and Phenylephrine hydrochloride SOLUTION ORAL 20140930 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/5mL; mg/5mL N 20181231 50580-342_056dd304-133c-4e19-ae29-05de311b0077 50580-342 HUMAN OTC DRUG SUDAFED 12 HOUR Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170901 ANDA ANDA075153 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 50580-367_ef66d241-4852-47f2-8d9e-a1beb279fe2e 50580-367 HUMAN OTC DRUG Imodium A-D Loperamide Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160711 NDA NDA021855 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 50580-370_886f167e-77b8-4a6e-82dd-4fbf17f3b938 50580-370 HUMAN OTC DRUG Benadryl diphenhydramine hydrochloride KIT 20170612 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division N 20181231 50580-378_680f9e8b-f85d-48fd-9679-716b6c074b6a 50580-378 HUMAN OTC DRUG Tylenol Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20141101 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 500 mg/1 N 20181231 50580-402_76e2325c-87f5-4d07-856f-5fc0c66e4e9b 50580-402 HUMAN OTC DRUG TYLENOL Cold Plus Flu Severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20110901 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 50580-403_b9224a8f-e5b8-44c0-9b0f-ca4dccafa90d 50580-403 HUMAN OTC DRUG TYLENOL COLD PLUS FLU SEVERE Acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION ORAL 20100705 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 50580-404_6f314b2f-8838-4853-a2a8-21ce9246d0cd 50580-404 HUMAN OTC DRUG TYLENOL COLD PLUS SORE THROAT Extra Strength Acetaminophen SOLUTION ORAL 20100716 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 500 mg/15mL N 20181231 50580-409_3e4d0fa2-ff25-4d9e-8e8c-7ef20c10b59f 50580-409 HUMAN OTC DRUG Motrin IB Ibuprofen CAPSULE, LIQUID FILLED ORAL 20150126 ANDA ANDA078682 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division IBUPROFEN 200 mg/1 N 20181231 50580-412_8851a351-49b8-430b-9903-3aa2116e267f 50580-412 HUMAN OTC DRUG TYLENOL Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20160919 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 500 mg/1 N 20181231 50580-414_aeee89ae-8972-4ce3-9645-5e1e6e713b86 50580-414 HUMAN OTC DRUG TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride KIT 20160718 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division N 20181231 50580-415_94209431-ef0e-4606-a88f-18c453d9b16c 50580-415 HUMAN OTC DRUG Benadryl Allergy Plus Congestion Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20170619 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 25; 10 mg/1; mg/1 N 20181231 50580-424_caef41ca-a394-49dd-8bd0-2581f14b6e3e 50580-424 HUMAN OTC DRUG Childrens TYLENOL ACETAMINOPHEN SUSPENSION ORAL 20170116 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-433_9e418ccb-f9e5-42b5-8794-5d5a024900d5 50580-433 HUMAN OTC DRUG Infants TYLENOL Acetaminophen SUSPENSION ORAL 20170807 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-449_7a941847-ddaa-4241-aeab-24da046400a3 50580-449 HUMAN OTC DRUG TYLENOL Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19840819 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 500 mg/1 N 20191231 50580-451_8c8f78fd-425a-42ab-ad6b-7c827000381e 50580-451 HUMAN OTC DRUG TYLENOL Extra Strength Acetaminophen TABLET, COATED ORAL 19940819 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 500 mg/1 N 20181231 50580-456_b72c5ee8-9be5-4bb1-8bfc-e834a8cc9f0a 50580-456 HUMAN OTC DRUG Childrens TYLENOL COLD Plus FLU Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride SUSPENSION ORAL 20170626 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20191231 50580-487_25c041f0-d104-4fb2-8eae-dad611693c22 50580-487 HUMAN OTC DRUG Tylenol Regular Strength Acetaminophen CAPSULE, LIQUID FILLED ORAL 20160105 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 325 mg/1 N 20181231 50580-488_c01f2cd0-1942-46cc-925c-d1c2a8e05b48 50580-488 HUMAN OTC DRUG TYLENOL Extra Strength Acetaminophen TABLET, COATED ORAL 20170116 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 500 mg/1 N 20191231 50580-496_34e5cd75-7465-47cc-aedd-f4af6ae13b79 50580-496 HUMAN OTC DRUG TYLENOL Regular Strength Acetaminophen TABLET ORAL 19990201 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 325 mg/1 N 20181231 50580-501_f91a8208-682b-4092-a01f-08332b6c73b6 50580-501 HUMAN OTC DRUG TYLENOL Regular Strength Acetaminophen TABLET, FILM COATED ORAL 19990201 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 325 mg/1 N 20181231 50580-506_67c7da7f-0428-4bcb-9fde-0f521f9fef68 50580-506 HUMAN OTC DRUG Tylenol PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20140929 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 50580-507_e4023bb2-c985-408a-988d-13028991c99f 50580-507 HUMAN OTC DRUG Tylenol Sinus Severe Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20150515 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 50580-509_b2f5a299-5659-4b91-9d39-abbf3f084841 50580-509 HUMAN OTC DRUG Childrens TYLENOL Acetaminophen SUSPENSION ORAL 20170116 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-510_96c65ef7-bc67-4b65-b365-3a46f1805b7b 50580-510 HUMAN OTC DRUG Childrens RHINOCORT Allergy Budesonide SPRAY, METERED NASAL 20170116 NDA NDA020746 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division BUDESONIDE 32 ug/1 N 20181231 50580-511_06a64e2d-2564-4652-9eae-76484d1c5d2c 50580-511 HUMAN OTC DRUG TYLENOL Cold Plus Mucus Severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine hydrochloride SOLUTION ORAL 20150622 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 50580-515_ce596551-c1da-4862-b32e-83bb6d6da78d 50580-515 HUMAN OTC DRUG TYLENOL COLD MAX DAY acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride TABLET, FILM COATED ORAL 20150715 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 50580-521_63af2c45-d7f5-4300-b5bb-0a45712bbfa8 50580-521 HUMAN OTC DRUG Childrens TYLENOL Acetaminophen TABLET, CHEWABLE ORAL 20170227 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/1 N 20191231 50580-522_2d43130f-947d-4688-8534-3077e3126cb7 50580-522 HUMAN OTC DRUG Childrens Tylenol Acetaminophen TABLET, CHEWABLE ORAL 20170227 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/1 N 20191231 50580-525_5d7c632b-cba3-4090-aec4-4d7c7f31fb7d 50580-525 HUMAN OTC DRUG TYLENOL COLD MAX DAY Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride SOLUTION ORAL 20150525 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 50580-534_72f0618d-954a-4946-b6f4-f818ed5314cc 50580-534 HUMAN OTC DRUG Childrens Benadryl ALLERGY Diphenhydramine hydrochloride SOLUTION ORAL 20080701 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 50580-535_45abb8ba-ca25-437a-93fd-4e609e146f0e 50580-535 HUMAN OTC DRUG Childrens Benadryl DYE-FREE ALLERGY Diphenhydramine hydrochloride SOLUTION ORAL 20080701 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 50580-536_5ebcf366-e81f-4ed7-8efd-2b03411f74ad 50580-536 HUMAN OTC DRUG Childrens Sudafed Nasal Decongestant Pseudoephedrine hydrochloride SOLUTION ORAL 20081001 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg/5mL N 20181231 50580-539_da2dd8dd-76fe-4d9c-91d7-664d5c39ff21 50580-539 HUMAN OTC DRUG Sudafed 12 Hour Pressure And Pain Naproxen sodium and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101101 ANDA ANDA076518 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 50580-545_c9f34262-e43b-4ea5-9be4-ef13724f8103 50580-545 HUMAN OTC DRUG SUDAFED Pseudoephedrine Hydrochloride TABLET, COATED ORAL 20111001 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 50580-546_6251fa24-d4f3-4e41-a873-25188c2334fe 50580-546 HUMAN OTC DRUG Sudafed PE Congestion Phenylephrine Hydrochloride TABLET ORAL 20150713 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 50580-547_171e1fdf-0e73-40a8-a22e-8a593a5f6d95 50580-547 HUMAN OTC DRUG SUDAFED PE Pressure Plus Pain acetaminophen and phenylephrine hydrochloride TABLET, FILM COATED ORAL 20120701 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 50580-550_f0f27e98-4a14-42ae-ab2d-cad2fb1f3370 50580-550 HUMAN OTC DRUG Sudafed PE Pressure plus Pain plus Cough Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20130225 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 50580-563_73d34d19-1b41-4b6e-92d9-93a8f7c24882 50580-563 HUMAN OTC DRUG Motrin PM Ibuprofen and Diphenhydramine Citrate TABLET, COATED ORAL 20100111 ANDA ANDA079113 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division IBUPROFEN; DIPHENHYDRAMINE CITRATE 200; 38 mg/1; mg/1 N 20181231 50580-566_cd29bf35-b5f3-4f6f-99bd-53a9cfb0012f 50580-566 HUMAN OTC DRUG Tylenol Cold Plus Head Congestion Severe Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20130715 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 50580-571_12495891-4dcc-43e7-b883-f4d0ef981a00 50580-571 HUMAN OTC DRUG TYLENOL COLD MAX NIGHT Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride SOLUTION ORAL 20150413 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 50580-579_23731061-2dc3-4b44-8a10-aa359170ed23 50580-579 HUMAN OTC DRUG Childrens TYLENOL Acetaminophen SUSPENSION ORAL 20170116 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-598_f392985c-f78b-454e-bddd-090800e83167 50580-598 HUMAN OTC DRUG TYLENOL SINUS PLUS HEADACHE DAY Acetaminophen and Phenylephrine hydrochloride TABLET, FILM COATED ORAL 20150715 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 50580-599_27464945-14cd-4bf8-84eb-a900e91aaf16 50580-599 HUMAN OTC DRUG Infants TYLENOL acetaminophen SUSPENSION ORAL 20170626 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-600_e66866f8-143f-40cf-a1c3-1a21781d93d3 50580-600 HUMAN OTC DRUG TYLENOL Regular Strength Acetaminophen TABLET, FILM COATED ORAL 20170531 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 325 mg/1 N 20181231 50580-601_09e9b344-d098-4587-9102-406124bf84be 50580-601 HUMAN OTC DRUG Childrens MOTRIN Ibuprofen SUSPENSION ORAL 19950901 NDA NDA020516 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division IBUPROFEN 100 mg/5mL N 20181231 50580-603_ef939aee-a526-4f5d-9f6b-44065f24cba7 50580-603 HUMAN OTC DRUG Childrens Motrin Ibuprofen SUSPENSION ORAL 20160125 NDA NDA020516 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division IBUPROFEN 100 mg/5mL N 20181231 50580-604_8573c01c-4b7c-44e4-a135-137cc6e8724a 50580-604 HUMAN OTC DRUG Childrens Motrin Ibuprofen SUSPENSION ORAL 20160125 NDA NDA020516 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division IBUPROFEN 100 mg/5mL N 20181231 50580-608_9e743229-c716-42f1-9620-3ed52aeb922d 50580-608 HUMAN OTC DRUG Tylenol PM Extra Strength acetaminophen and diphenhydramine hydrochloride TABLET, FILM COATED ORAL 20160711 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 50580-612_7a3684e9-f528-4b17-baa3-b13cf9d177ab 50580-612 HUMAN OTC DRUG Childrens TYLENOL Acetaminophen SUSPENSION ORAL 20160801 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-614_08fe1415-dc2d-4386-83c5-ecc678ba0dcd 50580-614 HUMAN OTC DRUG Childrens TYLENOL ACETAMINOPHEN SUSPENSION ORAL 20160801 OTC MONOGRAPH NOT FINAL part343 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 160 mg/5mL N 20181231 50580-646_b091a9a7-c26e-4acb-9b8c-0fee989467a7 50580-646 HUMAN OTC DRUG RHINOCORT Allergy budesonide SPRAY, METERED NASAL 20160114 NDA NDA020746 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division BUDESONIDE 32 ug/1 N 20181231 50580-669_e569f8c0-4f16-498d-bedb-8a1ac7a3e2d6 50580-669 HUMAN OTC DRUG Sudafed 24 Hour Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20081001 NDA NDA020021 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division PSEUDOEPHEDRINE HYDROCHLORIDE 240 mg/1 N 20181231 50580-670_f6cc4ab8-ce62-4811-a55e-ace614fee4b8 50580-670 HUMAN OTC DRUG Sudafed 12 Hour Pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080601 ANDA ANDA073585 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 50580-679_824180e0-436f-4f21-97aa-023f5ec1f8bc 50580-679 HUMAN OTC DRUG Sudafed PE Pressure Plus Pain Plus Cold Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20130801 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 50580-680_760330ed-4a48-4345-b117-8769564158a6 50580-680 HUMAN OTC DRUG SUDAFED PE Pressure PLUS Pain PLUS Mucus Acetaminophen, Guaifenesin, and Phenylephrine hydrochloride TABLET, FILM COATED ORAL 20130701 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 50580-721_11a712d7-d6c1-4291-a561-b1957b054116 50580-721 HUMAN OTC DRUG Childrens Zyrtec Allergy Cetirizine Hydrochloride SYRUP ORAL 20090120 NDA NDA022155 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 50580-726_0c0d7bf6-e10e-4d32-83d3-08dc39b8c436 50580-726 HUMAN OTC DRUG Zyrtec Allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20080101 NDA NDA019835 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 50580-728_ec5415c8-4bc0-4bba-8505-6f0d37e1b3a2 50580-728 HUMAN OTC DRUG ZYRTEC-D Allergy Plus Congestion Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080101 NDA NDA021150 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 50580-730_0060c096-9ea8-4967-882c-5a739387e776 50580-730 HUMAN OTC DRUG Childrens Zyrtec Cetirizine Hydrochloride SYRUP ORAL 20090601 NDA NDA022155 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 50580-736_3631044f-259d-4822-9368-6a3eb7f5ce30 50580-736 HUMAN OTC DRUG SUDAFED PE DAY PLUS NIGHT SINUS CONGESTION Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride KIT 20170626 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division N 20181231 50580-778_3a640dce-3522-4db5-95d3-37ddd7c6697f 50580-778 HUMAN OTC DRUG Zyrtec Allergy Cetirizine Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20140120 NDA NDA022578 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 50580-779_e1537226-1719-4fb4-a9b0-422478850521 50580-779 HUMAN OTC DRUG ZYRTEC Cetirizine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100208 NDA NDA022429 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 50580-782_9b31aa7a-cda4-4772-8b74-78d79be41146 50580-782 HUMAN OTC DRUG Childrens Zyrtec Allergy Cetirizine Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20140120 NDA NDA022578 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 50580-783_3e831b11-b312-48d8-a3ba-5d0a6d8f05ee 50580-783 HUMAN OTC DRUG Tylenol 8 HR Arthritis Pain Acetaminophen TABLET, EXTENDED RELEASE ORAL 20150713 NDA NDA019872 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ACETAMINOPHEN 650 mg/1 N 20191231 50580-784_4ee5a0f0-e24b-4db5-9d9e-0d88fbd88d6b 50580-784 HUMAN OTC DRUG Childrens Sudafed PE NASAL DECONGESTANT Phenylephrine hydrochloride SOLUTION ORAL 20081001 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL N 20181231 50580-785_28c68f63-36fc-4a8c-a6a6-5aa1e504e2bb 50580-785 HUMAN OTC DRUG Childrens SUDAFED PE Cold plus Cough Dextromethorphan hydrobromide and Phenylephrine hydrochloride SOLUTION ORAL 20081001 OTC MONOGRAPH FINAL part341 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 50580-843_e2a44920-55cc-4b66-be51-af7fa476e7d6 50580-843 HUMAN OTC DRUG Simply Sleep diphenhydramine hydrochloride TABLET, FILM COATED ORAL 20040201 OTC MONOGRAPH FINAL part338 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50580-895_b1ab7972-edcf-4ee8-bd1d-4eb24b10ef78 50580-895 HUMAN OTC DRUG Nizoral A-D Ketoconazole SHAMPOO TOPICAL 19990401 NDA NDA020310 Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division KETOCONAZOLE 10 mg/mL N 20181231 50593-001_77f40592-d27e-45af-ab84-d48dc95b44c9 50593-001 HUMAN OTC DRUG Pink Grape Fruit Waterless Anti-bacterial Hand Sanitizer Alcohol LIQUID TOPICAL 20100210 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. ALCOHOL 62 g/100g E 20171231 50593-002_0083c1f9-9189-4ca0-9f6a-249450b913f1 50593-002 HUMAN OTC DRUG Healing Waters Cucumber Mint Antibacterial Hand Soap TRICLOSAN LIQUID TOPICAL 20100210 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. TRICLOSAN .115 g/100g E 20171231 50593-003_948df7ae-0e0d-49dd-a55b-282fadb84bc6 50593-003 HUMAN OTC DRUG Healing Waters Mandarin Vanilla Antibacterial Hand Soap TRICLOSAN LIQUID TOPICAL 20100210 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. TRICLOSAN .115 g/100g E 20171231 50593-004_4b7b4a08-75d6-42ae-a287-bf098e162c95 50593-004 HUMAN OTC DRUG Healing Waters Sweet Pea Antibacterial Hand Soap TRICLOSAN LIQUID TOPICAL 20100210 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. TRICLOSAN .115 g/100g E 20171231 50593-005_9eaf54fb-5951-44f0-a194-c735fbbf87aa 50593-005 HUMAN OTC DRUG Clinical Works Cucumber Melon Waterless Hand Sanitizer Alcohol LIQUID TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. ALCOHOL 62 g/100g E 20171231 50593-006_eac3dd3f-f0d9-4be9-9b40-fbd47fabb775 50593-006 HUMAN OTC DRUG Clinical Works Lavender Blossom Waterless Hand Sanitizer Alcohol LIQUID TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. ALCOHOL 62 g/100g E 20171231 50593-007_beecd4bf-d696-4d57-8f5b-ba72335650f0 50593-007 HUMAN OTC DRUG Clinical Works Pink Grapefruit Waterless Hand Sanitizer Alcohol LIQUID TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. ALCOHOL 62 g/100g E 20171231 50593-008_31c5471f-3a5d-41a3-b7f2-3dd5931cca45 50593-008 HUMAN OTC DRUG Clinical Works Ocean Breeze Waterless Hand Sanitizer Alcohol LIQUID TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part333 Taizhou Xinzhixuan Daily-Use Co., Ltd. ALCOHOL 62 g/100g E 20171231 50594-001_92b40e7c-98d6-4880-8b08-8031d2d1c36d 50594-001 HUMAN OTC DRUG sound body stomach relief Bismuth subsalicylate SUSPENSION ORAL 20150421 OTC MONOGRAPH FINAL part335 Big Lots Stores, Inc. BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 50594-002_42753067-07cb-4759-939a-dc580e1e7a8e 50594-002 HUMAN OTC DRUG sound body acid reducer Famotidine TABLET ORAL 20150521 ANDA ANDA077351 Big Lots Stores, Inc. FAMOTIDINE 20 mg/1 N 20181231 50594-003_46c899f3-3601-489b-9203-1c84efa1b5f5 50594-003 HUMAN OTC DRUG Sound Body Calcium Antacid calcium carbonate TABLET, CHEWABLE ORAL 20150710 OTC MONOGRAPH FINAL part331 Big Lots Stores, Inc. CALCIUM CARBONATE 1000 mg/1 N 20181231 50594-004_a932bbe4-795a-4b3c-b52d-a1b4c8f47e42 50594-004 HUMAN OTC DRUG Sound Body Calcium Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20150626 OTC MONOGRAPH FINAL part331 Big Lots Stores, Inc. CALCIUM CARBONATE 750 mg/1 N 20181231 50594-005_1dc4c593-80ac-4889-9118-1255dcae68e8 50594-005 HUMAN OTC DRUG sound body ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20150421 ANDA ANDA077349 Big Lots Stores, Inc. IBUPROFEN 200 mg/1 N 20181231 50594-006_047a04a4-16b5-479d-b4f4-496c19f95095 50594-006 HUMAN OTC DRUG sound body all day allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20150428 ANDA ANDA078336 Big Lots Stores, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 50594-007_019e3707-7dff-4ce0-997e-d8dd904e0d83 50594-007 HUMAN OTC DRUG sound body stomach relief Bismuth subsalicylate SUSPENSION ORAL 20150529 OTC MONOGRAPH FINAL part335 Big Lots Stores, Inc. BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 50594-008_b9dfeb2a-cba4-4bff-a1dd-9c37589ec5ec 50594-008 HUMAN OTC DRUG sound body nighttime sleep aid Diphenhydramine HCl SOLUTION ORAL 20150421 OTC MONOGRAPH FINAL part338 Big Lots Stores, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 50594-010_528f3d32-90c5-42b2-a308-7f7806b81814 50594-010 HUMAN OTC DRUG Sound Body Allergy Relief Loratadine TABLET ORAL 20150612 ANDA ANDA076301 Big Lots Stores, Inc. LORATADINE 10 mg/1 N 20181231 50594-011_5e72b06d-5724-4c1b-8eb7-721cfd3f317b 50594-011 HUMAN OTC DRUG Sound Body Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20150817 NDA NDA022032 Big Lots Stores, Inc. OMEPRAZOLE 20 mg/1 N 20181231 50594-012_d2e545ea-edef-4dcc-b506-1b562e1bb15d 50594-012 HUMAN OTC DRUG Sound Body Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20160119 OTC MONOGRAPH NOT FINAL part343 Big Lots Stores, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 50594-013_a295a7d5-aac8-4e82-91eb-bc67881b9541 50594-013 HUMAN OTC DRUG Sound Body Childrens Allergy Relief Diphenhydramine HCl SOLUTION ORAL 20160112 OTC MONOGRAPH FINAL part341 Big Lots Stores, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 50594-014_1a6215c0-d3ea-45e7-ab95-223ebe00a614 50594-014 HUMAN OTC DRUG Sound Body Cold and Flu Relief DayTime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20151015 OTC MONOGRAPH FINAL part341 Big Lots Stores, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 50594-015_68f167cb-15f1-4b75-97b5-3c2e0da664f8 50594-015 HUMAN OTC DRUG Sound Body Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20160324 OTC MONOGRAPH NOT FINAL part334 Big Lots Stores, Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 50594-016_99a74da9-c2f6-4985-944c-73012f59b0e8 50594-016 HUMAN OTC DRUG Sound Body Cold and Flu Relief acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20160503 OTC MONOGRAPH FINAL part341 Big Lots Stores, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 50594-017_f4e61108-f4df-4a84-8d62-87358cf97332 50594-017 HUMAN OTC DRUG Sound Body Nasal oxymetazoline hydrochloride SPRAY NASAL 20160503 OTC MONOGRAPH FINAL part341 Big Lots Stores, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 50594-018_45fc679b-fde2-47e2-8d4e-0fcac50e9546 50594-018 HUMAN OTC DRUG Sound Body Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20160503 ANDA ANDA074937 Big Lots Stores, Inc. IBUPROFEN 100 mg/5mL N 20181231 50594-019_25e6fce9-1455-4eff-9006-0fb92df22f01 50594-019 HUMAN OTC DRUG Sound Body Pain Reliever Acetaminophen TABLET ORAL 20160919 OTC MONOGRAPH NOT FINAL part343 Big Lots Stores, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 50594-020_d4b0a63e-d10f-48b8-b272-acafa41b338e 50594-020 HUMAN OTC DRUG Sound Body Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20160919 ANDA ANDA072096 Big Lots Stores, Inc. IBUPROFEN 200 mg/1 N 20181231 50594-021_56288bfc-6908-416f-9c3d-763e539c7da6 50594-021 HUMAN OTC DRUG Sound Body Tussin DM Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20160919 OTC MONOGRAPH FINAL part341 Big Lots Stores, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 50594-023_244f5cf1-98c5-4530-a49b-d5557d840298 50594-023 HUMAN OTC DRUG Sound Body Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20170420 OTC MONOGRAPH FINAL part341 Big Lots Stores, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 50594-024_133ae6de-e8b4-4351-aab1-a70dec61dde9 50594-024 HUMAN OTC DRUG Sound Body Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20170420 ANDA ANDA074661 Big Lots Stores, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 50594-025_9c530942-f98d-4b8c-bd9b-7437c67c1e0f 50594-025 HUMAN OTC DRUG Sound Body Allergy Relief fexofenadine hcl TABLET, FILM COATED ORAL 20170426 ANDA ANDA076447 Big Lots Stores, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 50594-026_a323e398-cf39-47c1-94b0-77008f6aa09d 50594-026 HUMAN OTC DRUG Sound Body Acid Reducer Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20170420 ANDA ANDA202319 Big Lots Stores, Inc. LANSOPRAZOLE 15 mg/1 N 20181231 50594-027_e2c3e146-108c-4ad1-a61c-70c540c19a45 50594-027 HUMAN OTC DRUG sound body cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20170330 OTC MONOGRAPH FINAL part341 Big Lots Stores, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 50594-030_481ae869-00ed-0c55-e054-00144ff8d46c 50594-030 HUMAN OTC DRUG Menthol cough drop menthol LOZENGE ORAL 20150305 OTC MONOGRAPH FINAL part341 Big Lots MENTHOL 5.4 mg/1 N 20181231 50594-031_49c3b47a-f894-568a-e054-00144ff8d46c 50594-031 HUMAN OTC DRUG Menthol cough drop menthol LOZENGE ORAL 20170201 OTC MONOGRAPH FINAL part341 Sound Body MENTHOL 5.4 mg/1 N 20181231 50594-032_49d44219-d521-0768-e054-00144ff88e88 50594-032 HUMAN OTC DRUG menthol cough drop cherry menthol LOZENGE ORAL 20130924 OTC MONOGRAPH FINAL part341 Sound Body MENTHOL 5.8 mg/1 N 20181231 50594-033_4a116e0c-20ea-55db-e054-00144ff8d46c 50594-033 HUMAN OTC DRUG Menthol Cough drop Cherry Menthol LOZENGE ORAL 20170201 OTC MONOGRAPH FINAL part341 Sound Body MENTHOL 5.8 mg/1 N 20181231 50594-034_4a253d99-7230-5406-e054-00144ff8d46c 50594-034 HUMAN OTC DRUG Menthol cough drop Honey Lemon menthol LOZENGE ORAL 20130924 OTC MONOGRAPH FINAL part341 Sound Body MENTHOL 7.5 mg/1 N 20181231 50594-035_4a38ee66-5465-5bae-e054-00144ff88e88 50594-035 HUMAN OTC DRUG Menthol cough drop Honey Lemon menthol LOZENGE ORAL 20170201 OTC MONOGRAPH FINAL part341 Sound Body MENTHOL 7.5 mg/1 N 20181231 50594-036_4a4e2759-49ea-20db-e054-00144ff8d46c 50594-036 HUMAN OTC DRUG Sugar Free menthol cough drop Sugar Free Cherry LOZENGE ORAL 20151006 OTC MONOGRAPH FINAL part341 Sound Body MENTHOL 5.8 mg/1 N 20181231 50594-037_4a61318b-2116-531c-e054-00144ff88e88 50594-037 HUMAN OTC DRUG Sugar Free menthol cough drop Sugar Free Honey Lemon LOZENGE ORAL 20170201 OTC MONOGRAPH FINAL part341 Sound Body MENTHOL 7.6 mg/1 N 20181231 50594-038_5e32b0e7-55cb-2a49-e053-2991aa0a23b4 50594-038 HUMAN OTC DRUG Menthol cough drops Menthol LOZENGE ORAL 20171117 OTC MONOGRAPH FINAL part341 Big Lots MENTHOL 5.4 mg/1 N 20181231 50594-039_5e33b13e-d73d-72e8-e053-2a91aa0af70b 50594-039 HUMAN OTC DRUG Cherry cough drops Menthol LOZENGE ORAL 20171117 OTC MONOGRAPH FINAL part341 Big Lots MENTHOL 5.8 mg/1 N 20181231 50594-040_5e345fde-35db-d3d2-e053-2a91aa0ac227 50594-040 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20171117 OTC MONOGRAPH FINAL part341 Big Lots MENTHOL 7.5 mg/1 N 20181231 50594-041_9c49da08-04a9-40d2-b3fc-5612dd09d9a4 50594-041 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20150429 OTC MONOGRAPH FINAL part333D Big Lots SALICYLIC ACID 19.8 mg/g N 20181231 50594-042_5f89ba8c-abe0-247b-e053-2a91aa0a5009 50594-042 HUMAN OTC DRUG Sugar Free Honey Lemon Cough Drops Menthol LOZENGE ORAL 20171204 OTC MONOGRAPH FINAL part341 Big Lots MENTHOL 7.6 mg/1 N 20181231 50594-069_72c6d416-b547-49d3-94c2-9d170a14b074 50594-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20150129 OTC MONOGRAPH FINAL part347 Big Lots PETROLATUM 1 g/g N 20181231 50594-072_ea9a5c13-0cf6-4b94-a5e2-07d84f62fa28 50594-072 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20150430 OTC MONOGRAPH NOT FINAL part356 Big Lots EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 50594-153_33a981a1-f13c-47f8-aab2-6f7b3bd8ae82 50594-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione zinc SHAMPOO TOPICAL 20150429 OTC MONOGRAPH FINAL part358H Big Lots PYRITHIONE ZINC 10 mg/mL N 20181231 50594-163_6347e9e3-d54d-4d2b-a742-c15f36a2e43d 50594-163 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20160317 OTC MONOGRAPH FINAL part355 Big Lots SODIUM FLUORIDE .1 mg/mL N 20181231 50594-205_046f1b06-a1c2-4083-abe5-29d541dfee4e 50594-205 HUMAN OTC DRUG Therapeutic Anti-Dandruff Coal Tar SHAMPOO TOPICAL 20160318 OTC MONOGRAPH FINAL part358H Big Lots COAL TAR 25 mg/mL N 20181231 50594-229_8203beaa-8716-4d84-a445-cc4d88de6a20 50594-229 HUMAN OTC DRUG Acne Treatment Benzoyl peroxide GEL TOPICAL 20160223 OTC MONOGRAPH FINAL part333D Big Lots BENZOYL PEROXIDE 1 mg/g N 20181231 50594-296_800b1759-618d-42f1-a03c-88ba9014a012 50594-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20150429 OTC MONOGRAPH FINAL part358H Big Lots PYRITHIONE ZINC 10 mg/mL N 20181231 50594-335_c5f396f0-f383-44ac-bdaa-5b44e0a832af 50594-335 HUMAN OTC DRUG sound body cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20150304 OTC MONOGRAPH FINAL part341 Big Lots Stores, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 50594-459_a979d6b0-13f0-4971-8ee6-b1ba3e2856bc 50594-459 HUMAN OTC DRUG sound body cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20150304 OTC MONOGRAPH FINAL part341 Big Lots Stores, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 50594-529_2e7c6282-7a76-4717-a77f-26fb1b9138f8 50594-529 HUMAN OTC DRUG Sound Body SALICYLIC ACID CREAM TOPICAL 20160501 OTC MONOGRAPH FINAL part333D Big Lots Stores, Inc. SALICYLIC ACID 2 g/100g N 20181231 50594-530_8f9c748f-8d73-4ab1-8e86-3b319e055ff2 50594-530 HUMAN OTC DRUG Sound Body SALICYLIC ACID GEL TOPICAL 20160501 OTC MONOGRAPH FINAL part333D Big Lots Stores, Inc. SALICYLIC ACID 2 g/100g N 20181231 50594-602_b0c0158b-b4ed-48c7-8f3e-760637377e09 50594-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20150721 OTC MONOGRAPH NOT FINAL part334 Meijer Distribution, Inc MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20191231 50594-612_a5aab3ea-72c7-417b-8db4-d894f853f241 50594-612 HUMAN OTC DRUG 2 in 1 Dandruff Pyrithione zinc SHAMPOO TOPICAL 20160118 OTC MONOGRAPH FINAL part358H Big Lots PYRITHIONE ZINC 1 g/mL N 20181231 50594-619_a4c28e82-617f-4ec4-bcba-72d7d721f178 50594-619 HUMAN OTC DRUG Daily Moisturizing Daily Moistruizing LOTION TOPICAL 20150429 OTC MONOGRAPH FINAL part347 Big Lots DIMETHICONE 13 mg/mL N 20181231 50594-664_80653928-a925-45d2-844e-c2d46acad90f 50594-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20150430 OTC MONOGRAPH NOT FINAL part356 Big Lots EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 50594-667_3ecd0c98-3be4-4593-bb78-456028435037 50594-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20160309 OTC MONOGRAPH NOT FINAL part334 Big Lots MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 50594-734_f4aaef35-32d5-4ace-a3b8-26b6c728b299 50594-734 HUMAN OTC DRUG sound body nicotine Nicotine Polacrilex LOZENGE ORAL 20171120 ANDA ANDA203690 Big Lots Stores, Inc. NICOTINE 2 mg/1 N 20191231 50594-804_16112a64-875d-4dce-8eca-112d0ce1ddbb 50594-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20160329 OTC MONOGRAPH NOT FINAL part333A Big Lots ISOPROPYL ALCOHOL 910 mg/mL N 20181231 50594-810_38735f33-72a9-4e93-91a4-9d0f704ee750 50594-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20150909 OTC MONOGRAPH NOT FINAL part333A Big Lots ISOPROPYL ALCOHOL 500 mg/mL N 20181231 50594-821_add375f3-99de-444c-9965-23ceba182149 50594-821 HUMAN OTC DRUG Acne Scrub Salicylic Acid GEL TOPICAL 20150115 OTC MONOGRAPH FINAL part333D Big Lots SALICYLIC ACID 21 mg/mL N 20181231 50594-822_9b7371ac-ed3e-40a0-82b9-b0c3b33ecef3 50594-822 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20150430 OTC MONOGRAPH FINAL part346 Big Lots WITCH HAZEL 979 mg/mL N 20181231 50594-875_5dabd9ab-44a4-48cb-a923-7f4387a6aa37 50594-875 HUMAN OTC DRUG Astringent Salicylic Acid LIQUID TOPICAL 20160315 OTC MONOGRAPH FINAL part333D Big Lots SALICYLIC ACID 5 mg/mL N 20181231 50597-010_a75ce2b8-f359-4bcc-a474-52605f809b64 50597-010 HUMAN PRESCRIPTION DRUG Oxygen oxygen GAS RESPIRATORY (INHALATION) 20100504 UNAPPROVED MEDICAL GAS W. H. Goodale Co. Inc. OXYGEN 210 mL/L E 20171231 50600-001_416869ea-9d24-4d29-941a-95cf59eac966 50600-001 HUMAN OTC DRUG Correway Personal Lubricant Glycerin JELLY ENTERAL 20090501 OTC MONOGRAPH NOT FINAL part347 Ningbo Correway Cosmetics Co., Ltd. GLYCERIN 19.312 g/48.28g E 20171231 50600-002_7b68e830-c387-492a-a31a-2f2001e1ca69 50600-002 HUMAN OTC DRUG Correway Sunscreen (Non-waterproof) Octinoxate CREAM TOPICAL 20100308 OTC MONOGRAPH NOT FINAL part352 Ningbo Correway Cosmetics Co., Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 75; 50; 35; 35 mg/g; mg/g; mg/g; mg/g E 20171231 50600-003_fa432f97-c3e0-467d-a7d4-ada152c50677 50600-003 HUMAN OTC DRUG Correway Sunscreen (Waterproof) Zinc Oxide CREAM TOPICAL 20100423 OTC MONOGRAPH NOT FINAL part352 Ningbo Correway Cosmetics Co., Ltd. ZINC OXIDE; OCTINOXATE; ENZACAMENE; AVOBENZONE 80; 70; 35; 10 mg/g; mg/g; mg/g; mg/g E 20171231 50600-004_edf63270-e217-4ad3-ad85-46b53fc77777 50600-004 HUMAN OTC DRUG Correway Sunscreen (Non-waterproof) Octinoxate CREAM TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part352 Ningbo Correway Cosmetics Co., Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 75; 50; 35; 35 mg/g; mg/g; mg/g; mg/g E 20171231 50607-1111_fb5e49f7-4aae-4bf4-bdc4-ba23bb2a7412 50607-1111 HUMAN OTC DRUG Instant Hand Sanitizer Instant Hand Sanitizer GEL TOPICAL 20100501 OTC MONOGRAPH FINAL part333 B8 Sales, Inc. ALCOHOL .6 g/.9g N 20181231 50607-5600_51d351ee-2de5-45f1-a1c2-e1b05433a300 50607-5600 HUMAN OTC DRUG Triple Antibiotic Triple Antibiotic OINTMENT TOPICAL 20100501 OTC MONOGRAPH FINAL part333 B8 Sales, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 1/g; mg/g; 1/g N 20181231 50607-5700_ecdf4659-d30b-42a6-a987-168a2e391542 50607-5700 HUMAN OTC DRUG First aid and Burn First aid and Burn CREAM TOPICAL 20100501 OTC MONOGRAPH FINAL part333 B8 Sales, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g N 20181231 50607-5802_9fa5a9a0-ed3b-4d00-8f8f-bd91076f587c 50607-5802 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20100501 OTC MONOGRAPH FINAL part347 B8 Sales, Inc. HYDROCORTISONE 10 mg/g N 20181231 50629-1005_f3631ad1-cfe5-45b1-8062-3a76dc1a4aa7 50629-1005 HUMAN OTC DRUG RICHENNAPHARM GROWMAX Hair care Tonic LEVOMENTHOL LIQUID TOPICAL 20100428 UNAPPROVED DRUG OTHER SEWHA P&C INC LEVOMENTHOL; ALPHA-TOCOPHEROL ACETATE .4; .2 mL/200mL; mL/200mL E 20171231 50629-1010_c76e93dd-0da7-41eb-9319-d44ad0c1bb92 50629-1010 HUMAN OTC DRUG MOLYHEN MENTHOL LIQUID TOPICAL 20110629 UNAPPROVED DRUG OTHER SEWHA P&C INC MENTHOL; .ALPHA.-TOCOPHEROL ACETATE, D-; SWERTIA JAPONICA; PYRIDOXINE HYDROCHLORIDE 4; 2; 10; 2 mL/200mL; mL/200mL; mL/200mL; mL/200mL E 20171231 50633-110_25ffdbf0-8e0f-40ac-ae05-c0f83ba6a4e9 50633-110 HUMAN PRESCRIPTION DRUG CroFab ovine crotalidae venoms immune fab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20000210 BLA BLA103788 BTG International Inc. CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE); AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE); CROTALUS SCUTULATUS IMMUNE FAB ANTIVENIN (OVINE); CROTALUS ADAMANTEUS IMMUNE FAB ANTIVENIN (OVINE) 1; 1; 1; 1 g/1; g/1; g/1; g/1 Antivenin [EPC],Passively Acquired Immunity [PE],Venom Neutralization [MoA],Antivenins [Chemical/Ingredient],Antivenin [EPC],Passively Acquired Immunity [PE],Venom Neutralization [MoA],Antivenins [Chemical/Ingredient],Passively Acquired Immunity [PE],Venom Neutralization [MoA],Antivenins [Chemical/Ingredient],Antivenin [EPC],Antivenin [EPC],Passively Acquired Immunity [PE],Venom Neutralization [MoA],Antivenins [Chemical/Ingredient] N 20181231 50633-120_23e6b396-31d3-46cd-e054-00144ff88e88 50633-120 HUMAN PRESCRIPTION DRUG DigiFab ovine digoxin immune fab INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010831 BLA BLA103910 BTG International Inc. OVINE DIGOXIN IMMUNE FAB 40 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 50633-210_2645decc-fcc7-48ab-a217-029dcd6d8ccc 50633-210 HUMAN PRESCRIPTION DRUG Voraxaze glucarpidase INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120401 BLA BLA125327 BTG International Inc. GLUCARPIDASE 1000 [USP'U]/1 Carboxypeptidase [EPC],Carboxypeptidases [Chemical/Ingredient] N 20181231 50636-001_d2248934-7fc8-4f1f-9ca7-4fd5fcd91b0f 50636-001 HUMAN OTC DRUG antiperspirant deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331 OTC MONOGRAPH FINAL part350 Frabel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 mL/100mL E 20171231 50636-002_0fe7be41-1ff2-43f4-9831-3fc1983b5d69 50636-002 HUMAN OTC DRUG antiperspirant deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331 OTC MONOGRAPH FINAL part350 Frabel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 mL/100mL E 20171231 50636-003_7f404ca0-d463-416a-a7ce-dbf3404fc63d 50636-003 HUMAN OTC DRUG antiperspirant deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331 OTC MONOGRAPH FINAL part350 Frabel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 mL/100mL E 20171231 50636-004_9d6e2def-c6ee-4dc7-9023-564c04e25958 50636-004 HUMAN OTC DRUG antiperspirant deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331 OTC MONOGRAPH FINAL part350 Frabel S.A de C.V. ALUMINUM CHLOROHYDRATE 15 mL/100mL E 20171231 50653-1001_3d47d557-c24e-49e7-840f-ca0cbf48a9b7 50653-1001 HUMAN OTC DRUG Bonogen hair care shampoo panthenol SHAMPOO TOPICAL 20100301 UNAPPROVED DRUG OTHER Bonogen Co., Ltd PANTHENOL; BIOTIN; NADIDE; PYRITHIONE ZINC .5; .06; .3; 2.1 g/100g; g/100g; g/100g; g/100g E 20171231 50653-2001_7d820b69-58e8-4834-8131-cc58ad762124 50653-2001 HUMAN OTC DRUG Bonogen Plus hair care shampoo panthenol SHAMPOO TOPICAL 20100409 UNAPPROVED DRUG OTHER Bonogen Co., Ltd PANTHENOL; BIOTIN; NADIDE; PYRITHIONE ZINC .6; .06; .3; 2.1 g/100g; g/100g; g/100g; g/100g E 20171231 50653-3001_ff548e74-db58-404e-be2b-1d85db798467 50653-3001 HUMAN OTC DRUG Bonogen Activator hair loss treatment BIOTIN LIQUID TOPICAL 20100425 UNAPPROVED DRUG OTHER Bonogen Co., Ltd BIOTIN .002 mL/mL E 20171231 50653-4001_f86f54eb-fac3-4ba7-8d67-a49c7df6a0c7 50653-4001 HUMAN OTC DRUG Born Hair panthenol SHAMPOO TOPICAL 20100409 UNAPPROVED DRUG OTHER Bonogen Co., Ltd PANTHENOL; BIOTIN; NADIDE; PYRITHIONE ZINC .6; .06; .3; 2.1 g/100g; g/100g; g/100g; g/100g E 20171231 50664-100_5163e38a-5b1c-4cf9-88a8-95030d88a329 50664-100 HUMAN OTC DRUG Herbasoul Male Genital Desensitizer Cream BENZOCAINE CREAM TOPICAL 20100223 OTC MONOGRAPH FINAL part348 Bodon Med Laboratories Ltd. BENZOCAINE 4.5 g/100g E 20171231 50666-001_e5b471da-8358-4e09-a4b6-d647b716a078 50666-001 HUMAN OTC DRUG JIANZE ALCOHOL PREP PAD LARGE ISOPROPYL ALCOHOL SWAB TOPICAL 20120601 OTC MONOGRAPH FINAL part333A Changzhou Jianze Sanitary Material Co., Ltd. ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 50666-002_b44c4d10-4b2e-4064-bc13-8cfc5726f6b6 50666-002 HUMAN OTC DRUG JIANZE ALCOHOL PREP PAD MEDIUM ISOPROPYL ALCOHOL SWAB TOPICAL 20120601 OTC MONOGRAPH FINAL part333A Changzhou Jianze Sanitary Material Co., Ltd. ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 50666-003_3ae904dc-012e-4e47-9183-8186aaa53102 50666-003 HUMAN OTC DRUG JIANZE SURGICAL SCRUB BRUSH NAIL CLEANER POVIDONE-IODINE SPONGE TOPICAL 20120601 OTC MONOGRAPH FINAL part333E Changzhou Jianze Sanitary Material Co., Ltd. POVIDONE-IODINE 2 g/20g E 20171231 50666-004_d6b92858-ceed-4880-90a0-c991d5d082f4 50666-004 HUMAN OTC DRUG JIANZE ALCOHOL ISOPROPYL ALCOHOL SWAB TOPICAL 20120606 OTC MONOGRAPH FINAL part333A Changzhou Jianze Sanitary Material Co., Ltd. ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 50666-005_8568d2c8-f9f4-4fcc-8745-b59927950f54 50666-005 HUMAN OTC DRUG JIANZE POVIDONE-IODINE POVIDONE-IODINE GEL TOPICAL 20120614 OTC MONOGRAPH FINAL part333E Changzhou Jianze Sanitary Material Co., Ltd. POVIDONE-IODINE 10 g/100g E 20171231 50666-006_c6df728b-a711-4e1f-acc8-6e188c1368de 50666-006 HUMAN OTC DRUG JIANZE POVIDONE IODINE SCRUB POVIDONE-IODINE LIQUID TOPICAL 20120614 OTC MONOGRAPH FINAL part333E Changzhou Jianze Sanitary Material Co., Ltd. POVIDONE-IODINE 10 g/100g E 20171231 50666-007_3a942c4f-72d0-4963-ac8b-831cbd46a948 50666-007 HUMAN OTC DRUG JIANZE FIRST AID ANTISEPTIC SKIN TOWELETTE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120614 OTC MONOGRAPH FINAL part333A Changzhou Jianze Sanitary Material Co., Ltd. BENZALKONIUM CHLORIDE .13 g/100g E 20171231 50666-008_2043ea3a-4c3a-499d-bfc8-f1664f3ceeeb 50666-008 HUMAN OTC DRUG JIANZE STING RELIEF PADS BENZOCAINE LIQUID TOPICAL 20120614 OTC MONOGRAPH FINAL part348 Changzhou Jianze Sanitary Material Co., Ltd. BENZOCAINE 6 g/100g E 20171231 50666-009_a2de7bd5-82e1-4c78-8941-24181fc913d9 50666-009 HUMAN OTC DRUG JIANZE WASH TOWELETTE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120614 OTC MONOGRAPH FINAL part333A Changzhou Jianze Sanitary Material Co., Ltd. BENZALKONIUM CHLORIDE .13 g/100g E 20171231 50672-838_93d9496a-952d-456b-9738-fceb351103b6 50672-838 HUMAN OTC DRUG Antibacterial Wet Wipes Benzalkonium Chloride SWAB TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A MC Group Development Ltd. BENZALKONIUM CHLORIDE .1 g/100g E 20171231 50682-507_409093a5-b4f0-4857-b3d6-3d40481511d4 50682-507 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20120116 UNAPPROVED DRUG OTHER 3T Federal Solutions LLC SALSALATE 500 mg/1 E 20171231 50682-508_409093a5-b4f0-4857-b3d6-3d40481511d4 50682-508 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20120116 UNAPPROVED DRUG OTHER 3T Federal Solutions LLC SALSALATE 750 mg/1 E 20171231 50682-527_dec971e0-6bec-4ae4-aec4-76c8ded82c47 50682-527 HUMAN OTC DRUG LidoPatch Pain Relief lidocaine and menthol PATCH TRANSDERMAL 20120201 OTC MONOGRAPH NOT FINAL part348 3T Federal Solutions LLC LIDOCAINE; MENTHOL 40; 50 mg/1; mg/1 E 20171231 50685-001_c00d1071-a360-415d-af59-4c23d64e53f1 50685-001 HUMAN OTC DRUG Good Care Povidone Iodine POVIDONE-IODINE SWAB TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. POVIDONE-IODINE 10 mL/100mL N 20181231 50685-002_24bb3855-c800-441e-ac3e-5ab6a3b199b1 50685-002 HUMAN OTC DRUG Good Care Isopropyl Alcohol ISOPROPYL ALCOHOL SWAB TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 50685-004_2614486b-10d2-4b2b-87d0-a8c5ff269471 50685-004 HUMAN OTC DRUG Good Care Surgical Brush With Nail Cleaner POVIDONE-IODINE SPONGE TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. POVIDONE-IODINE 10 mL/100mL N 20181231 50685-005_f31bd0b5-a920-4807-a0b7-093101e3537e 50685-005 HUMAN OTC DRUG Good Care Surgical Brush With Nail Cleaner POVIDONE-IODINE SPONGE TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. POVIDONE-IODINE 7.5 mL/100mL N 20181231 50685-006_c71b9e6b-b633-404e-83fe-ef3f950cc0ad 50685-006 HUMAN OTC DRUG Good Care Alcohol Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. ISOPROPYL ALCOHOL 70 g/100g N 20181231 50685-007_dc36edc7-08b8-435e-9071-3f9e0c739d33 50685-007 HUMAN OTC DRUG Good Care Povidone Iodine Pad POVIDONE-IODINE SWAB TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. POVIDONE-IODINE 10 g/100g N 20181231 50685-008_424d19aa-9e50-42a7-8a79-0892060bf151 50685-008 HUMAN OTC DRUG Good Care Sterile Scrub Brush with PCMX CHLOROXYLENOL SOLUTION TOPICAL 20130213 OTC MONOGRAPH FINAL part333E Dalian Goodwood Medical Care Ltd. CHLOROXYLENOL 3.3 g/100g N 20181231 50685-009_acfdbb6e-316a-4fa0-9819-7612d49eb92b 50685-009 HUMAN OTC DRUG Good Care Povidone Iodine Swabsticks POVIDONE-IODINE SWAB TOPICAL 20130213 OTC MONOGRAPH FINAL part333E Dalian Goodwood Medical Care Ltd. POVIDONE-IODINE 10 g/100g N 20181231 50685-010_d89a86cf-4736-410d-97bd-418f6dde6b13 50685-010 HUMAN OTC DRUG BZK BENZALKONIUM CHLORIDE SWAB TOPICAL 20150319 OTC MONOGRAPH NOT FINAL part333A Dalian Goodwood Medical Care Ltd. BENZALKONIUM CHLORIDE 1 mg/g N 20181231 50693-276_da33d3c6-f991-4c07-b3ed-5929e9af5a55 50693-276 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19790101 UNAPPROVED MEDICAL GAS Dixie Welding Supply Co, Inc. OXYGEN 99.5 L/100L E 20171231 50699-1072_53262f28-6f93-41f7-bb05-fa513c553bcd 50699-1072 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19770101 NDA NDA205865 Atlas Welding Supply Co., Inc. OXYGEN 99 L/100L N 20181231 50699-1977_3b38927a-ad66-47dd-ac1d-03490b5f2749 50699-1977 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19770101 NDA NDA205866 Atlas Welding Supply Co, Inc. NITROGEN 99 L/100L N 20181231 50718-0012_a2df5fb6-08c9-4df5-ac02-cf596e17ccc0 50718-0012 HUMAN OTC DRUG Calm Eczema Therapy Wash Sulphur 12X LIQUID TOPICAL 20180101 UNAPPROVED HOMEOPATHIC Kamedis SULFUR 12 [hp_X]/mL N 20191231 50718-0021_b1463b21-0412-4636-b736-a7c22466b738 50718-0021 HUMAN OTC DRUG Control Dandruff Therapy dandruff therapy shampoo SHAMPOO TOPICAL 20180101 OTC MONOGRAPH FINAL part358H Kamedis PYRITHIONE ZINC 10 mg/mL N 20191231 50718-0032_c24a4700-51ac-4141-b1e8-423ee8b0d1f2 50718-0032 HUMAN OTC DRUG Clear Acne Spot Treatment Acne Spot Treatment LIQUID TOPICAL 20180101 UNAPPROVED HOMEOPATHIC Kamedis SALICYLIC ACID 28.8 mg/mL N 20191231 50728-510_8926bd49-6c43-44ce-b8fd-3c9905ad5065 50728-510 HUMAN OTC DRUG Nans Healing Aconitum Napellus, Arnica Montana, Arsenicum Iodatum, Belladonna, Bellis Perenis, Bryonia, Calendula Officinalis, Chamomilla Matricaria, Echinacea Angustifolia, Echinacea Purpurea, Graphites, Hamameli OINTMENT TOPICAL 20100801 UNAPPROVED HOMEOPATHIC Eycnan, LLC ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIIODIDE; BELLADONNA LEAF; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; ACHILLEA MILLEFOLIUM; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; STELLARIA MEDIA; SULFUR; COMFREY ROOT; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 8; 3; 3; 3; 3; 3; 3; 3; 8; 3; 4; 3; 8; 3; 3; 9; 6; 3; 3; 4; 3; 5; 3; 3 [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_C]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g; [hp_X]/57g E 20171231 50730-1000_e8f9eebb-679f-4252-b54a-652fa7a0479b 50730-1000 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .13 mL/mL E 20171231 50730-1001_12b9b3c5-5a05-4595-87bc-cc53bcbf1fd7 50730-1001 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .13 mL/mL E 20171231 50730-1004_2e9ca551-7499-44bf-b013-228f7e3bdff1 50730-1004 HUMAN OTC DRUG Bisacodyl bisacodyl SUPPOSITORY RECTAL 20090101 OTC MONOGRAPH FINAL part334 H and P Industries, Inc. dba Triad Group BISACODYL 10 mg/1 E 20171231 50730-1016_7c90787f-4b8f-48a9-a416-35d7c5f1b5e8 50730-1016 HUMAN OTC DRUG Bisacodyl bisacodyl SUPPOSITORY RECTAL 20090101 OTC MONOGRAPH FINAL part334 H and P Industries, Inc. dba Triad Group BISACODYL 10 mg/1 E 20171231 50730-1020_c5c5716a-a492-4e6d-bbbf-05fdb9ffbff8 50730-1020 HUMAN OTC DRUG Isopropyl Alcohol Swabs isopropyl alcohol SWAB TOPICAL 20071001 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 E 20171231 50730-1033_3552f34e-b5c4-48ce-8060-47c766193011 50730-1033 HUMAN OTC DRUG Isopropyl alcohol Prep Pad isopropyl alcohol SWAB TOPICAL 20070928 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 E 20171231 50730-1059_0ecd0a0a-2d8d-42a8-af4a-8201a7cacd4c 50730-1059 HUMAN OTC DRUG Isopropyl alcohol Prep Pad isopropyl alcohol SWAB TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 E 20171231 50730-1089_edc68e78-f911-4a5a-8c76-8d448f3edee6 50730-1089 HUMAN OTC DRUG Isopropyl Alcohol Swabs isopropyl alcohol SWAB TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 E 20171231 50730-1091_5d77ae33-8fe6-41f1-b028-ba5a6d003b03 50730-1091 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20090701 OTC MONOGRAPH FINAL part334 H and P Industries, Inc. dba Triad Group GLYCERIN 2 g/1 E 20171231 50730-1092_6c6213c3-4563-4b0b-b676-f348ec934036 50730-1092 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20030420 OTC MONOGRAPH FINAL part334 H and P Industries, Inc. dba Triad Group GLYCERIN 1.614 g/1 E 20171231 50730-1238_56b021e0-497c-44dc-9ddf-87f6ffe81f7c 50730-1238 HUMAN OTC DRUG Isopropyl Alcohol Prep Swab isopropyl alcohol SWAB TOPICAL 20030601 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 E 20171231 50730-1404_975d3fa6-36b6-49dd-8f42-30eae5ebce00 50730-1404 HUMAN OTC DRUG Alcohol Swabs with Benzocaine alcohol and benzocaine SWAB TOPICAL 20100405 OTC MONOGRAPH NOT FINAL part348 Triad Group BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 E 20171231 50730-1410_cac2e470-8e7c-406a-8606-f320b1ca90fc 50730-1410 HUMAN OTC DRUG Alcohol Prep Pad with Benzocaine benzocaine SWAB TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part348 H and P Industries, Inc. dba Triad Group BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 E 20171231 50730-1411_0de077c4-4843-4d07-aa29-86475adc3f8f 50730-1411 HUMAN OTC DRUG Alcohol Prep Pad with Benzocaine benzocaine SWAB TOPICAL 20080701 OTC MONOGRAPH NOT FINAL part348 H and P Industries, Inc. dba Triad Group BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 E 20171231 50730-1450_b025f2ae-2e20-4cff-bbca-65c9239226ec 50730-1450 HUMAN OTC DRUG Alcohol Prep Swab with Pain Relief benzocaine SWAB TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part348 H and P Industries, Inc. dba Triad Group BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mL/1; mL/1 E 20171231 50730-1481_ec714dbf-89f7-476e-bad9-a8ef85aa6837 50730-1481 HUMAN OTC DRUG cocoa butter, phenylephrine hydrochloride, shark liver oil cocoa butter, phenylephrine hydrochloride, shark liver oil SUPPOSITORY RECTAL 20040306 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2077; 6; 73 mg/1; mg/1; mg/1 E 20171231 50730-1512_1162e9c4-000e-488f-b042-043743aad63c 50730-1512 HUMAN OTC DRUG Hemorrhoidal Starch starch SUPPOSITORY RECTAL 20060801 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group STARCH, CORN .51 g/1 E 20171231 50730-2000_52ca50c3-5890-4f93-ab96-67b39ddb13dc 50730-2000 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .13 mL/mL E 20171231 50730-2001_d4aa6122-d5aa-4144-b45e-cbeaa358e738 50730-2001 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .13 mL/mL E 20171231 50730-2005_04b7b28b-3470-49c7-a4a7-b6aead4020a8 50730-2005 HUMAN OTC DRUG Cold Sore Treatment Benzalkonium Chloride TINCTURE TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .13 mL/mL E 20171231 50730-3001_e185f1ee-efff-4b33-b693-ffce9a28ef5b 50730-3001 HUMAN OTC DRUG Isopropyl alcohol isopropyl alcohol SWAB TOPICAL 19860501 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 E 20171231 50730-3002_613db179-9d50-4c78-a55e-a74e5f7d3fe1 50730-3002 HUMAN OTC DRUG Isopropyl alcohol isopropyl alcohol SWAB TOPICAL 19860501 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 E 20171231 50730-3003_f45899d3-8868-4729-a0c3-354cae3d0bcd 50730-3003 HUMAN OTC DRUG Isopropyl alcohol isopropyl alcohol SWAB TOPICAL 19860501 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 E 20171231 50730-3004_99770d6c-f3d8-4605-8884-eb690b3c771d 50730-3004 HUMAN OTC DRUG Isopropyl alcohol isopropyl alcohol SWAB TOPICAL 19860501 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 E 20171231 50730-3101_90755816-c7dd-449b-9ac4-ee25289818ba 50730-3101 HUMAN OTC DRUG Isopropyl alcohol isopropyl alcohol SWAB TOPICAL 19960930 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/1 E 20171231 50730-3201_fb26f261-407b-4f86-881e-f0fd068f9ceb 50730-3201 HUMAN OTC DRUG Povidone Iodine Prep Pad povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .1 g/1 E 20171231 50730-4101_195f25e7-21ce-4c6d-bedb-b79ceb28b385 50730-4101 HUMAN OTC DRUG Povidone-Iodine Prep Swabstick povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .1 mg/mL E 20171231 50730-4102_021d76b8-2021-43e7-be7c-cf9135742bcb 50730-4102 HUMAN OTC DRUG Povidone-Iodine Prep Swabsticks povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 Triad Group POVIDONE-IODINE .1 mg/mL E 20171231 50730-4300_96758b29-178e-4fd4-97af-ce05768de078 50730-4300 HUMAN OTC DRUG Isopropyl alcohol Swabsticks isopropyl alcohol LIQUID TOPICAL 19860501 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/mL E 20171231 50730-4301_323b2954-3b60-43ce-823c-692832ea9695 50730-4301 HUMAN OTC DRUG Isopropyl alcohol Swabstick Sterile isopropyl alcohol LIQUID TOPICAL 19860501 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ISOPROPYL ALCOHOL .7 mL/mL E 20171231 50730-4401_605ef4ee-a9f1-4437-8882-c071bba9caad 50730-4401 HUMAN OTC DRUG Povidone-Iodine Scrub Swabstick povidone-iodine SOLUTION TOPICAL 19870114 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .075 mg/mL E 20171231 50730-4402_0926eb7c-d18c-4f74-bc07-79e1c0852e89 50730-4402 HUMAN OTC DRUG Povidone-Iodine Scrub Swabsticks povidone-iodine SOLUTION TOPICAL 19870114 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .075 mg/mL E 20171231 50730-4536_ed0362d7-00a3-4082-b613-93b865efccce 50730-4536 HUMAN OTC DRUG mineral oil, petrolatum, phenylephrine hydrochloride, shark liver oil mineral oil, petrolatum, phenylephrine hydrochloride, shark liver oil OINTMENT RECTAL; TOPICAL 20050701 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group LIGHT MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 140; 719; 2.5; 30 mg/g; mg/g; mg/g; mg/g E 20171231 50730-4812_1065863d-fc11-4ca8-86f2-76ba8eba05c5 50730-4812 HUMAN OTC DRUG phenylephrine hydrochloride phenylephrine hydrochloride SUPPOSITORY RECTAL 20090301 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2077; 6; 73 mg/1; mg/1; mg/1 E 20171231 50730-5101_562fdc6a-587d-4751-900f-734dcdf30a22 50730-5101 HUMAN OTC DRUG BZK Antiseptic Towelette benzalkonium chloride SOLUTION TOPICAL 19971017 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .0013 mL/1 E 20171231 50730-5102_4f082dc2-bac8-4d2c-901f-381c65c2e7cc 50730-5102 HUMAN OTC DRUG OB Towelette benzalkonium chloride SOLUTION TOPICAL 19990701 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .004 mL/1 E 20171231 50730-5150_419e24a2-9ce1-4768-871e-79d85ce678a1 50730-5150 HUMAN OTC DRUG BZK Plus Swabsticks benzalkonium chloride SOLUTION TOPICAL 20030210 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .0013 mL/mL E 20171231 50730-5151_c07da60d-33ca-4cc7-b48a-31c38943e264 50730-5151 HUMAN OTC DRUG BZK Plus Prep Pad benzalkonium chloride SOLUTION TOPICAL 20030210 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .0013 mL/1 E 20171231 50730-5201_9bd7c888-e159-4f13-b98e-4441c315fb14 50730-5201 HUMAN OTC DRUG BZK Towelette benzalkonium chloride SOLUTION EPIDURAL; TOPICAL 19970828 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group BENZALKONIUM CHLORIDE .0013 mL/1 E 20171231 50730-5400_6eb90f61-5c21-4232-ae64-8d707fca13ee 50730-5400 HUMAN OTC DRUG Relief Towelette witch hazel SOLUTION TOPICAL 19941017 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group WITCH HAZEL .5 mL/1 E 20171231 50730-7100_96a14e06-0256-4d9f-9c25-e50037177909 50730-7100 HUMAN OTC DRUG Soothing Bath Treatment Colloidal Oatmeal POWDER TOPICAL 19951101 OTC MONOGRAPH FINAL part347 Triad Group OATMEAL 1 g/g E 20171231 50730-7502_0bc97563-7db2-40b8-b08c-b55acd9baec4 50730-7502 HUMAN OTC DRUG Relief witch hazel SWAB RECTAL; TOPICAL 19970114 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group WITCH HAZEL .5 mL/1 E 20171231 50730-7503_2ae8f16c-3de6-4ca5-9404-668ea20c9614 50730-7503 HUMAN OTC DRUG Hygienic Cleansing Pad witch hazel SOLUTION RECTAL; TOPICAL 20080301 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group WITCH HAZEL .5 mL/mL E 20171231 50730-7549_b0f0c2af-ef39-47ea-b3b4-af08a5c095e8 50730-7549 HUMAN OTC DRUG Medicated Pad witch hazel SOLUTION RECTAL; TOPICAL 20070201 OTC MONOGRAPH FINAL part346 H and P Industries, Inc. dba Triad Group WITCH HAZEL .5 mL/mL E 20171231 50730-7701_9aa4224e-0160-43a2-80ce-61e177aa757c 50730-7701 HUMAN OTC DRUG Medicated Acne Pads salicylic acid SWAB TOPICAL 20031202 OTC MONOGRAPH FINAL part333D H and P Industries, Inc. dba Triad Group SALICYLIC ACID .02 mL/1 E 20171231 50730-7801_20c9b7f4-9bba-4712-b47f-08805db3013d 50730-7801 HUMAN OTC DRUG Daily Cleansing salicylic acid SWAB TOPICAL 20030831 OTC MONOGRAPH FINAL part333D H and P Industries, Inc. dba Triad Group SALICYLIC ACID .02 mL/1 E 20171231 50730-7993_3ab22487-f897-4f83-aef7-0c6ceae92c95 50730-7993 HUMAN OTC DRUG Medicated Wipes witch hazel SOLUTION TOPICAL 20100413 OTC MONOGRAPH FINAL part346 Triad Group WITCH HAZEL .5 mL/mL E 20171231 50730-8201_65583b31-de0a-4fd4-a594-2d8a86079f6e 50730-8201 HUMAN OTC DRUG Povidone Iodine Plus povidone-iodine OINTMENT TOPICAL 20010501 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .1 g/g E 20171231 50730-8204_630e7a63-8a73-4af2-95f8-f8049baacb06 50730-8204 HUMAN OTC DRUG Triadine Prep povidone-iodine SOLUTION TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 Triad Group POVIDONE-IODINE .1 mg/mL E 20171231 50730-8214_fdf1b647-67ef-48f8-b14a-676ad7cc57e3 50730-8214 HUMAN OTC DRUG Povidone Iodine Plus povidone-iodine GEL TOPICAL 20010401 OTC MONOGRAPH NOT FINAL part333A H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .1 g/mL E 20171231 50730-8230_bce84330-48e5-4544-b2a4-d547dc85ffe6 50730-8230 HUMAN OTC DRUG Povidone Iodine povidone-iodine SOLUTION TOPICAL 20071206 OTC MONOGRAPH NOT FINAL part333A Triad Group POVIDONE-IODINE .1 mg/mL E 20171231 50730-8304_6919cacc-ec42-4b8e-9bd9-7d3da99eab12 50730-8304 HUMAN OTC DRUG Triadine Scrub povidone-iodine SOLUTION TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 Triad Group POVIDONE-IODINE .075 mL/mL E 20171231 50730-8308_2eb12584-c65b-4af6-9760-cc554dad229d 50730-8308 HUMAN OTC DRUG Triadine povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .075 mL/mL E 20171231 50730-8316_e85b8e2a-d879-4f02-90e2-da0d0c723bbf 50730-8316 HUMAN OTC DRUG Triadine povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .075 mL/mL E 20171231 50730-8328_1695c60d-5415-49a4-a131-03b212c7d7ab 50730-8328 HUMAN OTC DRUG Triadine povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .075 L/L E 20171231 50730-8332_9bbc5059-f040-4a4c-a293-6f46669b4e62 50730-8332 HUMAN OTC DRUG Triadine povidone-iodine SOLUTION EPIDURAL; PERCUTANEOUS; TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .075 mL/mL E 20171231 50730-8428_c9cd53bb-0345-49ba-bc38-3762c6ea8391 50730-8428 HUMAN OTC DRUG Triadine Whirlpool povidone-iodine SOLUTION TOPICAL 19850621 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group POVIDONE-IODINE .1 L/L E 20171231 50730-8604_e96d67d0-0edb-4057-83f4-7e00df3bc33e 50730-8604 HUMAN OTC DRUG Antiseptic Hand Gel ethyl alcohol GEL TOPICAL 19971117 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ALCOHOL .7 mL/mL E 20171231 50730-8608_5edbeea6-d9fc-40c7-ba5e-7e242e3bee4f 50730-8608 HUMAN OTC DRUG Antiseptic Hand Gel ethyl alcohol GEL TOPICAL 19971117 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ALCOHOL .7 mL/mL E 20171231 50730-8616_9d0fc5ee-99be-4b72-930f-ec3a7245f592 50730-8616 HUMAN OTC DRUG Antiseptic Hand Gel ethyl alcohol GEL TOPICAL 19971117 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ALCOHOL .7 mL/mL E 20171231 50730-8628_457094d1-02ad-411f-a2ad-fbf42845eafc 50730-8628 HUMAN OTC DRUG Antiseptic Hand Gel ethyl alcohol GEL TOPICAL 19971117 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ALCOHOL .7 L/L E 20171231 50730-8672_49997a44-d29b-4228-ab6e-c6de0b4133ed 50730-8672 HUMAN OTC DRUG ethyl alcohol ethyl alcohol GEL TOPICAL 19971117 OTC MONOGRAPH NOT FINAL part333 H and P Industries, Inc. dba Triad Group ALCOHOL .7 g/g E 20171231 50730-8712_d61fddbc-319f-4531-92ef-fa5629b608f1 50730-8712 HUMAN OTC DRUG Vitamin A and D petrolatum OINTMENT TOPICAL 20011231 OTC MONOGRAPH FINAL part347 H and P Industries, Inc. dba Triad Group PETROLATUM .948 g/g E 20171231 50730-8717_ac90561d-d907-47ce-b33d-3ff4a422b770 50730-8717 HUMAN OTC DRUG Vitamin A and D petrolatum OINTMENT TOPICAL 20040306 OTC MONOGRAPH FINAL part347 H and P Industries, Inc. dba Triad Group PETROLATUM .948 mL/mL E 20171231 50730-8719_214a3a07-87f0-4e95-bebc-210cd87aacb5 50730-8719 HUMAN OTC DRUG Vitamin A and D petrolatum OINTMENT TOPICAL 20040306 OTC MONOGRAPH FINAL part347 H and P Industries, Inc. dba Triad Group PETROLATUM .948 mL/mL E 20171231 50730-8744_2969534a-c2de-458a-90b1-9ffddc685260 50730-8744 HUMAN OTC DRUG Vitamin A and D petrolatum OINTMENT TOPICAL 20011231 OTC MONOGRAPH FINAL part347 H and P Industries, Inc. dba Triad Group PETROLATUM .948 g/g E 20171231 50742-112_53fb25aa-065f-45d3-9ca7-20b714391d22 50742-112 HUMAN PRESCRIPTION DRUG DESIPRAMINE HYDROCHLORIDE desipramine hydrochloride TABLET ORAL 20180106 ANDA ANDA204963 Ingenus Pharmaceuticals, LLC DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20191231 50742-113_53fb25aa-065f-45d3-9ca7-20b714391d22 50742-113 HUMAN PRESCRIPTION DRUG DESIPRAMINE HYDROCHLORIDE desipramine hydrochloride TABLET ORAL 20180106 ANDA ANDA204963 Ingenus Pharmaceuticals, LLC DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 50742-114_53fb25aa-065f-45d3-9ca7-20b714391d22 50742-114 HUMAN PRESCRIPTION DRUG DESIPRAMINE HYDROCHLORIDE desipramine hydrochloride TABLET ORAL 20180106 ANDA ANDA204963 Ingenus Pharmaceuticals, LLC DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 50742-115_53fb25aa-065f-45d3-9ca7-20b714391d22 50742-115 HUMAN PRESCRIPTION DRUG DESIPRAMINE HYDROCHLORIDE desipramine hydrochloride TABLET ORAL 20180106 ANDA ANDA204963 Ingenus Pharmaceuticals, LLC DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20191231 50742-116_53fb25aa-065f-45d3-9ca7-20b714391d22 50742-116 HUMAN PRESCRIPTION DRUG DESIPRAMINE HYDROCHLORIDE desipramine hydrochloride TABLET ORAL 20180106 ANDA ANDA204963 Ingenus Pharmaceuticals, LLC DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20191231 50742-117_53fb25aa-065f-45d3-9ca7-20b714391d22 50742-117 HUMAN PRESCRIPTION DRUG DESIPRAMINE HYDROCHLORIDE desipramine hydrochloride TABLET ORAL 20180106 ANDA ANDA204963 Ingenus Pharmaceuticals, LLC DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20191231 50742-135_457d1969-77ba-47c3-904e-95b1b3fa1db2 50742-135 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20160808 ANDA ANDA204467 Ingenus Pharmaceuticals LLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20191231 50742-136_457d1969-77ba-47c3-904e-95b1b3fa1db2 50742-136 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20160808 ANDA ANDA204467 Ingenus Pharmaceuticals LLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20191231 50742-152_4e112dce-66a9-4a2c-83d4-1e386581b628 50742-152 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20140401 ANDA ANDA078963 Ingenus Pharmaceuticals, LLC MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 50742-153_4e112dce-66a9-4a2c-83d4-1e386581b628 50742-153 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20140401 ANDA ANDA078963 Ingenus Pharmaceuticals, LLC MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 50742-154_21f8ca32-248d-42c5-9a3e-fc1fccd56a02 50742-154 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20140716 ANDA ANDA090564 Ingenus Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50742-155_21f8ca32-248d-42c5-9a3e-fc1fccd56a02 50742-155 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20140716 ANDA ANDA090564 Ingenus Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50742-156_21f8ca32-248d-42c5-9a3e-fc1fccd56a02 50742-156 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20140716 ANDA ANDA090564 Ingenus Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 50742-190_a975cc3a-8ddc-4bfc-9bc2-c08254a1880e 50742-190 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20150923 ANDA ANDA205087 Ingenus Pharmaceuticals LLC CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 50742-233_b60cc5d4-6dda-4239-bfb6-8fbccf893ee7 50742-233 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20170731 ANDA ANDA203434 Ingenus Pharmaceuticals, LLC ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 50742-234_33569dfb-6849-4de6-96b8-dc98f2548870 50742-234 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20170810 ANDA ANDA204853 Ingenus Pharmaceuticals, LLC INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50742-238_a7c71029-1908-49bb-bd2e-d65fdd62bbb4 50742-238 HUMAN PRESCRIPTION DRUG Quinine Sulfate Quinine Sulfate CAPSULE ORAL 20171211 ANDA ANDA204372 Ingenus Pharmaceuticals, LLC QUININE SULFATE 324 mg/1 Antimalarial [EPC] N 20181231 50742-304_8d3d73b9-b8c7-41be-aec3-d16e0489063a 50742-304 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate AEROSOL, FOAM TOPICAL 20170731 ANDA ANDA206805 Ingenus Pharmaceuticals, LLC CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50742-306_8f15e67d-3391-456d-a729-bf10a4dd095d 50742-306 HUMAN PRESCRIPTION DRUG LIDOCAINE Lidocaine OINTMENT TOPICAL 20170920 ANDA ANDA208604 Ingenus Pharmaceuticals, LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 50742-308_738244f8-7715-40f2-a6b4-1e4d91710043 50742-308 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Topical Solution Diclofenac Sodium SOLUTION TOPICAL 20171101 ANDA ANDA206715 Ingenus Pharmaceuticals, LLC DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 50742-315_801bac90-2ed7-4f68-9fa4-be1705b1f98c 50742-315 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate AEROSOL, FOAM TOPICAL 20170525 ANDA ANDA207144 Ingenus Pharmaceuticals LLC BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50742-401_bf428a1f-4537-47e7-acc7-4b971cef0596 50742-401 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20170605 ANDA ANDA206935 Ingenus Pharmaceuticals, LLC IRINOTECAN HYDROCHLORIDE 40 mg/2mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 50742-402_bf428a1f-4537-47e7-acc7-4b971cef0596 50742-402 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20170605 ANDA ANDA206935 Ingenus Pharmaceuticals, LLC IRINOTECAN HYDROCHLORIDE 100 mg/5mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 50742-404_e854f2d8-391c-4abf-9d69-b956cfdbf8c3 50742-404 HUMAN PRESCRIPTION DRUG Topotecan Topotecan INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20161207 ANDA ANDA206962 Ingenus Pharmaceuticals, LLC TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 50742-428_b598d9f9-09d4-48a8-bc07-5595890cdae9 50742-428 HUMAN PRESCRIPTION DRUG DOCETAXEL DOCETAXEL ANHYDROUS INJECTION, SOLUTION INTRAVENOUS 20170907 ANDA ANDA207563 Ingenus Pharmaceuticals, LLC DOCETAXEL ANHYDROUS 10 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 50742-431_b598d9f9-09d4-48a8-bc07-5595890cdae9 50742-431 HUMAN PRESCRIPTION DRUG DOCETAXEL DOCETAXEL ANHYDROUS INJECTION, SOLUTION INTRAVENOUS 20170907 ANDA ANDA207563 Ingenus Pharmaceuticals, LLC DOCETAXEL ANHYDROUS 10 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 50742-445_749e3705-98ff-43d8-b4db-763022973c83 50742-445 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20170506 ANDA ANDA208487 Ingenus Pharmaceuticals, LLC CARBOPLATIN 50 mg/5mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 50742-446_749e3705-98ff-43d8-b4db-763022973c83 50742-446 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20170506 ANDA ANDA208487 Ingenus Pharmaceuticals, LLC CARBOPLATIN 150 mg/15mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 50742-447_749e3705-98ff-43d8-b4db-763022973c83 50742-447 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20170506 ANDA ANDA208487 Ingenus Pharmaceuticals, LLC CARBOPLATIN 450 mg/45mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 50742-448_749e3705-98ff-43d8-b4db-763022973c83 50742-448 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20170506 ANDA ANDA208487 Ingenus Pharmaceuticals, LLC CARBOPLATIN 600 mg/60mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 50742-463_b598d9f9-09d4-48a8-bc07-5595890cdae9 50742-463 HUMAN PRESCRIPTION DRUG DOCETAXEL DOCETAXEL ANHYDROUS INJECTION, SOLUTION INTRAVENOUS 20170907 ANDA ANDA207563 Ingenus Pharmaceuticals, LLC DOCETAXEL ANHYDROUS 10 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 50742-513_d7a942d1-f10a-4ca4-a94f-4cf69d470eb9 50742-513 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 20171206 NDA NDA020145 Ingenus Pharmaceuticals, LLC NITROGLYCERIN 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50742-514_d7a942d1-f10a-4ca4-a94f-4cf69d470eb9 50742-514 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 20171206 NDA NDA020145 Ingenus Pharmaceuticals, LLC NITROGLYCERIN 40 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50742-515_d7a942d1-f10a-4ca4-a94f-4cf69d470eb9 50742-515 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 20171206 NDA NDA020145 Ingenus Pharmaceuticals, LLC NITROGLYCERIN 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50742-516_d7a942d1-f10a-4ca4-a94f-4cf69d470eb9 50742-516 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 20171206 NDA NDA020145 Ingenus Pharmaceuticals, LLC NITROGLYCERIN 80 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50742-517_d7a942d1-f10a-4ca4-a94f-4cf69d470eb9 50742-517 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 20171206 NDA NDA020145 Ingenus Pharmaceuticals, LLC NITROGLYCERIN 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50742-518_d7a942d1-f10a-4ca4-a94f-4cf69d470eb9 50742-518 HUMAN PRESCRIPTION DRUG NITRO-DUR nitroglycerin PATCH TRANSDERMAL 20171206 NDA NDA020145 Ingenus Pharmaceuticals, LLC NITROGLYCERIN 160 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 50742-620_7458c362-8a54-474a-9ce0-558c0cc39853 50742-620 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, EXTENDED RELEASE ORAL 20170215 ANDA ANDA202987 Ingenus Pharmaceuticals, LLC NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50742-621_7458c362-8a54-474a-9ce0-558c0cc39853 50742-621 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, EXTENDED RELEASE ORAL 20170215 ANDA ANDA202987 Ingenus Pharmaceuticals, LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50742-622_7458c362-8a54-474a-9ce0-558c0cc39853 50742-622 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, EXTENDED RELEASE ORAL 20170215 ANDA ANDA202987 Ingenus Pharmaceuticals, LLC NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 50742-623_47f8be59-178c-4bad-96a4-a5c82784f308 50742-623 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET ORAL 20170201 ANDA ANDA206974 Ingenus Pharmaceuticals, LLC LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 50742-624_47f8be59-178c-4bad-96a4-a5c82784f308 50742-624 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET ORAL 20170201 ANDA ANDA206974 Ingenus Pharmaceuticals, LLC LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 50742-635_b7c79af2-c2f2-480e-aa27-94a544346cdf 50742-635 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20171129 ANDA ANDA208947 Ingenus Pharmaceuticals, LLC QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 50742-636_b7c79af2-c2f2-480e-aa27-94a544346cdf 50742-636 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20171129 ANDA ANDA208947 Ingenus Pharmaceuticals, LLC QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 50742-637_b7c79af2-c2f2-480e-aa27-94a544346cdf 50742-637 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20171129 ANDA ANDA208947 Ingenus Pharmaceuticals, LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 50742-638_b7c79af2-c2f2-480e-aa27-94a544346cdf 50742-638 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20171129 ANDA ANDA208947 Ingenus Pharmaceuticals, LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 50742-639_b7c79af2-c2f2-480e-aa27-94a544346cdf 50742-639 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20171129 ANDA ANDA208947 Ingenus Pharmaceuticals, LLC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 50756-100_3281e14a-caeb-4b2b-be96-fd7de4e2d1ad 50756-100 HUMAN OTC DRUG Handex Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20100226 OTC MONOGRAPH FINAL part333 E T Inc. ALCOHOL 62 g/100g E 20171231 50757-250_f948039e-0c16-46d4-82a3-5ff69ab9efaa 50757-250 HUMAN OTC DRUG Pristall SaniShield Alcohol Free Antiseptic Hand Sanitizer BENZALKONIUM CHLORIDE SPRAY TOPICAL 20100323 OTC MONOGRAPH NOT FINAL part333 Sani Home Products International LLC BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 50760-8051_2a638f93-c367-4dfc-a347-9ce9dd0d54a5 50760-8051 HUMAN OTC DRUG DeNino Diaper Rash Rash Prevention Cream CREAM TOPICAL 20100401 OTC MONOGRAPH FINAL part347 Corpsain SA de CV ZINC OXIDE; AVENA SATIVA FLOWERING TOP; MEDIUM-CHAIN TRIGLYCERIDES; LANOLIN 7.8; .6; 18.21; 2.4 mL/60mL; mL/60mL; mL/60mL; mL/60mL E 20171231 50771-001_5cbe22d4-9274-2a1b-e053-2991aa0a2357 50771-001 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20160906 ANDA ANDA202036 Yaopharma Co., Ltd. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50771-002_5cbe22d4-9274-2a1b-e053-2991aa0a2357 50771-002 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20160906 ANDA ANDA202036 Yaopharma Co., Ltd. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50771-003_5cbe22d4-9274-2a1b-e053-2991aa0a2357 50771-003 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20160906 ANDA ANDA202036 Yaopharma Co., Ltd. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50771-004_5cbe22d4-9274-2a1b-e053-2991aa0a2357 50771-004 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20160906 ANDA ANDA202036 Yaopharma Co., Ltd. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50771-005_5cbe22d4-9274-2a1b-e053-2991aa0a2357 50771-005 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20160906 ANDA ANDA202036 Yaopharma Co., Ltd. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 50786-003_01f16fe3-dce6-402d-9dc1-084675f0c93e 50786-003 HUMAN OTC DRUG Valtrum Soothing Topical Analgesic camphor, menthol OINTMENT TOPICAL 20100506 OTC MONOGRAPH FINAL part348 Drogefar C.A. CAMPHOR (SYNTHETIC); MENTHOL 3; 3 mg/100mg; mg/100mg E 20171231 50788-001_1aa56720-08e1-42ab-b722-24c5f6ed9d15 50788-001 HUMAN OTC DRUG HONIBE MENTHOL LOZENGE ORAL 20120530 OTC MONOGRAPH NOT FINAL part348 Island Abbey Foods Ltd. MENTHOL 8.6 mg/2.5g N 20181231 50789-436_73ff8c2a-88a7-a5be-b001-c7a1e0d1f46e 50789-436 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20120101 UNAPPROVED MEDICAL GAS Maniilaq Association OXYGEN 930 mL/L E 20171231 50790-100_a43d8b25-96ec-4daf-8ab8-3958b6765e05 50790-100 HUMAN OTC DRUG Bortons Ethyl Rubbing Alcohol ALCOHOL LIQUID TOPICAL 20100430 OTC MONOGRAPH FINAL part333 J-Mark International Inc. ALCOHOL 82 mL/100mL E 20171231 50790-200_5539672f-b909-4818-8fb8-91939caa48b6 50790-200 HUMAN OTC DRUG Bortons Menticol Ethyl Alcohol, Menthol LIQUID TOPICAL 20100506 OTC MONOGRAPH FINAL part333 J-Mark International Inc ALCOHOL; MENTHOL 69.5; 1 mL/100mL; mL/100mL E 20171231 50795-1001_1fdf880e-68aa-4ed0-b49f-90e90ff41f43 50795-1001 HUMAN OTC DRUG U-max Wrinkle Serum ADENOSINE LIQUID TOPICAL 20120604 UNAPPROVED DRUG OTHER VS Shinbi Co., Ltd. ADENOSINE .04 mL/100mL E 20171231 50795-2001_98c788b5-3dba-461f-aa19-7c2faf9e0c7e 50795-2001 HUMAN OTC DRUG U-max Multi BB ALLANTOIN CREAM TOPICAL 20120604 UNAPPROVED DRUG OTHER VS Shinbi Co., Ltd. ALLANTOIN .1 mL/100mL E 20171231 50795-3001_5b0043d6-d1b2-4db0-ae40-f50be0148f4e 50795-3001 HUMAN OTC DRUG U-max Whitening Functional Essence ALLANTOIN CREAM TOPICAL 20120604 UNAPPROVED DRUG OTHER VS Shinbi Co., Ltd. ALLANTOIN .1 mL/100mL E 20171231 50795-4001_50d3b5dc-286a-468b-8857-c9a595a3e093 50795-4001 HUMAN OTC DRUG U-max Beauty CHITOSAN MEDIUM MOLECULAR WEIGHT (200-800 MPA.S) SOAP TOPICAL 20120612 UNAPPROVED DRUG OTHER VS Shinbi Co., Ltd. CHITOSAN MEDIUM MOLECULAR WEIGHT (200-800 MPA.S) 1 g/100g E 20171231 50802-001_00566b3d-e783-415b-8c96-3b629783aa40 50802-001 HUMAN OTC DRUG SierraSil Pain Relief Camphor SPRAY TOPICAL 20100301 OTC MONOGRAPH FINAL part348 Sierra Mountain Minerals Inc. d/b/a Sierra Sil Health Inc. CAMPHOR OIL 1 mL/30mL E 20171231 50804-001_1b96c658-3081-48a7-ad7c-d71b2c12e0d3 50804-001 HUMAN OTC DRUG Chocolated Laxative Sennosides Stimulant Laxative TABLET, CHEWABLE ORAL 20131001 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc SENNOSIDES 15 mg/1 E 20171231 50804-002_adf9390b-b234-4b58-8a6e-4af3fe5667ff 50804-002 HUMAN OTC DRUG Stimulant laxative plus stool softener docusate sodium and sennosides TABLET ORAL 20130411 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 50804-003_34b264e4-8aa7-6e70-e054-00144ff8d46c 50804-003 HUMAN OTC DRUG Pressure Plus Pain PE ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110401 OTC MONOGRAPH FINAL part341 GoodSense ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 50804-005_4b3930b0-23ac-46ae-b171-1067a01a8b9a 50804-005 HUMAN OTC DRUG Stool Softener Gentle DOCUSATE SODIUM CAPSULE ORAL 20100824 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) DOCUSATE SODIUM 100 mg/1 N 20181231 50804-006_33c29000-5c9d-00b3-e054-00144ff8d46c 50804-006 HUMAN OTC DRUG Pressure plus Pain PE plus Mucus ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20160530 OTC MONOGRAPH FINAL part341 GoodSense ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 50804-015_f0835eaf-4777-4356-8655-3f589d7339b5 50804-015 HUMAN OTC DRUG GoodSense Original Formula Eye Tetrahydrozoline HCI SOLUTION/ DROPS OPHTHALMIC 20160328 OTC MONOGRAPH FINAL part349 Geiss, Destin & Dunn, Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 50804-016_56efe535-7ba8-46d2-9505-d706f1f966be 50804-016 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 20111115 OTC MONOGRAPH NOT FINAL part343 Geiss, Destin & Dunn, Inc (Goodsense) ACETAMINOPHEN 500 mg/1 N 20181231 50804-017_ec31a216-6f23-420a-962b-b705633f8232 50804-017 HUMAN OTC DRUG GoodSense Artifical Tears Polyvinyl alcohol, and Povidone SOLUTION/ DROPS OPHTHALMIC 20160404 OTC MONOGRAPH FINAL part349 Geiss, Destin and Dunn, Inc. POLYVINYL ALCOHOL; POVIDONE .05; .06 g/mL; g/mL N 20181231 50804-018_8a9d6836-786e-49a6-834c-9f381ea31619 50804-018 HUMAN OTC DRUG GoodSense Irritation Relief Eye Tetrahydrozoline HCI, and Zinc sulfate SOLUTION/ DROPS OPHTHALMIC 20160324 OTC MONOGRAPH FINAL part349 Geiss, Destin & Dunn, Inc. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .05; 2.5 mg/mL; mg/mL N 20181231 50804-019_8e0d9e36-8396-4a8b-9d80-c31b49693e2f 50804-019 HUMAN OTC DRUG GoodSense Advanced Relief Eye Dextran 70, Polyethylene glycol 400, Povidone, and Tetrahydrozoline HCI SOLUTION/ DROPS OPHTHALMIC 20160324 OTC MONOGRAPH FINAL part349 Geiss, Destin & Dunn, Inc. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 50804-024_bf5d0819-f8a5-4089-8eaf-28c69e02b215 50804-024 HUMAN OTC DRUG Patch Good Sense Menthol PATCH TOPICAL 20161102 OTC MONOGRAPH NOT FINAL part348 Good Sense MENTHOL 775 mg/1 N 20181231 50804-047_741ba8db-9bd6-43d6-aa08-5f948678aeb5 50804-047 HUMAN OTC DRUG Good Sense Medicated WITCH HAZEL CLOTH TOPICAL 20151216 OTC MONOGRAPH FINAL part346 Geiss, Destin & Dunn, Inc WITCH HAZEL 500 mg/1 N 20181231 50804-060_52141725-71fd-41bd-a304-43a0d022159e 50804-060 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20150831 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 50804-072_240fce50-16ca-4f70-bfc0-c00c534ea078 50804-072 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20090815 OTC MONOGRAPH NOT FINAL part348 Geiss, Destin & Dunn, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 50804-076_a7ce504b-c87d-4a9a-b3df-a0a5e726d6d2 50804-076 HUMAN OTC DRUG GoodSense Antibiotic plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Geiss, Destin & Dunn, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 50804-080_d93e1136-2e52-4245-9842-897480bba17e 50804-080 HUMAN OTC DRUG GoodSense Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Geiss, Destin & Dunn, Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 50804-085_6e3de5a8-07a2-41bd-8e40-cb3b87219e07 50804-085 HUMAN OTC DRUG NASAL Allergy 24 Hour Triamcinolone Acetonide SPRAY, METERED NASAL 20150619 ANDA ANDA078104 Geiss, Destin & Dunn Inc. TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 50804-088_9f888067-c2a1-4b8f-bfeb-a43f50d5a35a 50804-088 HUMAN OTC DRUG Iodine Iodine LIQUID TOPICAL 20081108 OTC MONOGRAPH NOT FINAL part333A Geiss, Destin & Dunn, Inc IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 50804-092_b46093d4-340a-444a-a9ad-d3e8022f8eb8 50804-092 HUMAN OTC DRUG Good Sense Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Geiss, Destin & Dunn, Inc. LORATADINE 5 mg/5mL N 20181231 50804-100_bc8312b2-2ac7-4858-9527-d38d48acd4cc 50804-100 HUMAN OTC DRUG Daytime sinus Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120710 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 50804-101_e70f403f-42f0-445f-8d79-74272a3a0401 50804-101 HUMAN OTC DRUG Nighttime sinus Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120701 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 50804-107_431b5c0e-5ed7-47f7-a7e5-651b2968faee 50804-107 HUMAN OTC DRUG Mucus Releif Expectorant Guaifenesin TABLET ORAL 20130430 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) GUAIFENESIN 400 mg/1 N 20181231 50804-109_f628770f-7fc4-4761-8a42-6bd6b7746bb0 50804-109 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan Hydrobromide and Guaifenesin TABLET, COATED ORAL 20130430 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 50804-119_34b22acc-a124-6496-e054-00144ff8d46c 50804-119 HUMAN OTC DRUG Sinus Congestion and Pain Relief ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130701 OTC MONOGRAPH FINAL part341 GoodSense ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 50804-120_dd246c36-350d-4235-9de2-6e3b9d842f95 50804-120 HUMAN OTC DRUG womens laxative Bisacodyl TABLET ORAL 20130416 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) BISACODYL 5 mg/1 N 20181231 50804-126_602d5713-f679-17cc-e053-2a91aa0a2d77 50804-126 HUMAN OTC DRUG Goodsense Extra Strength Cold and Hot Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Geiss, Destin and Dunn, Inc. MENTHOL 750 mg/1 N 20181231 50804-138_34b22acc-a138-6496-e054-00144ff8d46c 50804-138 HUMAN OTC DRUG Cold Multi-Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130701 OTC MONOGRAPH FINAL part341 GoodSense ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 50804-140_b1b118a6-957e-43c8-afdc-3081dd908477 50804-140 HUMAN OTC DRUG Laxative pills maximum strength Sennosides TABLET ORAL 20100823 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) SENNOSIDES 25 mg/1 N 20181231 50804-156_113974fe-112e-42d8-952b-387e69f33f19 50804-156 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part356 Good Sense (Geiss, Destin & Dunn, Inc.) HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 50804-163_34b264e4-8abb-6e70-e054-00144ff8d46c 50804-163 HUMAN OTC DRUG Cold and Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130701 OTC MONOGRAPH FINAL part341 GoodSense ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 50804-165_ee3c77df-1306-4628-822f-8eb366205eb5 50804-165 HUMAN OTC DRUG Ibuprofen PM Ibuprofen and Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130115 ANDA ANDA090397 Geiss, Destin & Dunn, Inc (Goodsense) IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE 200; 25 mg/1; mg/1 E 20171231 50804-167_2e195b90-bfaf-4878-aaf8-c0844bc3eb35 50804-167 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20111222 ANDA ANDA079174 Geiss, Destin & Dunn, Inc (Goodsense) IBUPROFEN 200 mg/1 N 20181231 50804-174_34b12c8b-07e8-29b0-e054-00144ff88e88 50804-174 HUMAN OTC DRUG Pressure Plus Pain PE Plus Cold ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141201 OTC MONOGRAPH FINAL part341 GoodSense ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 50804-180_714dd62a-30c7-4f0a-9921-2586b5698832 50804-180 HUMAN OTC DRUG Goodsense Senna Sennosides TABLET ORAL 20121102 OTC MONOGRAPH FINAL part334 Geiss, Destin & Dunn, Inc. SENNOSIDES A AND B 8.6 mg/1 N 20181231 50804-183_d86ed97e-f582-47e9-847d-65f1eb2ad0c3 50804-183 HUMAN OTC DRUG Complete Menstrual Relief Acetaminophen, Caffeine, Pyrilamine maleate TABLET ORAL 20120116 OTC MONOGRAPH NOT FINAL part343 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 50804-184_5fba2491-9896-4a65-8ae8-07eec28f81cc 50804-184 HUMAN OTC DRUG Headache relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET ORAL 20120418 OTC MONOGRAPH NOT FINAL part343 Geiss, Destin & Dunn, Inc (Goodsense) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 50804-190_15954078-fd6b-41e5-af97-2a9a037614b3 50804-190 HUMAN OTC DRUG Bisacodyl Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20100716 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) BISACODYL 5 mg/1 N 20181231 50804-191_a4126c6d-bafb-4a9c-8d3f-b6f73fea6ee9 50804-191 HUMAN OTC DRUG Goodsense Oral Pain Relief Benzocaine GEL TOPICAL 20140509 OTC MONOGRAPH FINAL part333B Geiss, Destin and Dunn, Inc. BENZOCAINE 20 g/100g N 20181231 50804-199_4ce12e37-822c-4a3d-936d-a1eefd1f4cab 50804-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130423 ANDA ANDA078682 Good Sense (Geiss, Destin & Dunn, Inc.) IBUPROFEN 200 mg/1 N 20181231 50804-200_dbdb4715-3cc0-4808-b779-7c99a54789bb 50804-200 HUMAN OTC DRUG Sleep Aid Regular strength Diphenhydramine HCl TABLET ORAL 20100803 OTC MONOGRAPH FINAL part336 Geiss, Destin & Dunn, Inc (Goodsense) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50804-211_e20cff64-cc96-4446-bef2-389466763e97 50804-211 HUMAN OTC DRUG GOODSENSE Maximum Strength Medicated WITCH HAZEL CLOTH TOPICAL 20170727 OTC MONOGRAPH FINAL part346 GEISS, DESTIN & DUNN, INC WITCH HAZEL 50 g/100g N 20181231 50804-217_7399008c-d549-465e-aab6-1cfd850881ca 50804-217 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130413 ANDA ANDA079174 Good Sense (Geiss, Destin & Dunn, Inc.) IBUPROFEN 200 mg/1 N 20181231 50804-227_16517ce7-f1de-4e07-972d-6ed310999bfe 50804-227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH NOT FINAL part343 Geiss, Destin & Dunn, Inc (Goodsense) ASPIRIN 81 mg/1 N 20181231 50804-229_ff02cd73-98c8-4865-8b04-d89ef898a011 50804-229 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130331 OTC MONOGRAPH FINAL part338 Geiss, Destin & Dunn, Inc (Goodsense) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 50804-230_97d2e919-3722-490d-8740-55cf914491f5 50804-230 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20130415 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 50804-236_08a2a4ad-c049-438f-8727-c93cfa305527 50804-236 HUMAN OTC DRUG Nighttime sleep aid Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 50804-244_9faba0a2-0513-4a96-a1b9-9b4c40627268 50804-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) DOCUSATE SODIUM 100 mg/1 N 20181231 50804-245_7c89fe06-7643-43e1-83f6-b2c6ed1fa11b 50804-245 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20131202 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) SENNOSIDES 25 mg/1 N 20181231 50804-247_ab558fca-41e8-4779-b664-d707ba6455b5 50804-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20131230 OTC MONOGRAPH NOT FINAL part343 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 50804-252_23fd80de-477b-439c-a02e-cb3efa0fc2d0 50804-252 HUMAN OTC DRUG Sleep Aid Regular Strength Diphenhydramine HCl TABLET ORAL 20140228 OTC MONOGRAPH FINAL part338 Good Sense (Geiss, Destin & Dunn, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50804-275_e748e31f-4d53-48c3-8c9b-632b0fd805a2 50804-275 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20160831 OTC MONOGRAPH NOT FINAL part333A Good Sense (Geiss, Destin & Dunn, Inc.) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 50804-299_133ef5fe-9b3f-4397-aa17-aa3c2a5ea13b 50804-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 19930920 OTC MONOGRAPH NOT FINAL part356 Geiss, Destin and Dunn, Inc CETYLPYRIDINIUM CHLORIDE .07 kg/100L N 20181231 50804-302_26dcbffe-cdc5-4f58-a056-b1405504eb05 50804-302 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140620 ANDA ANDA077958 Good Sense KETOTIFEN FUMARATE .35 mg/mL N 20181231 50804-311_6ea5596d-dadb-4d32-a264-23775e785d6b 50804-311 HUMAN OTC DRUG Everyday Clean Pyrithione Zinc SHAMPOO TOPICAL 20090609 OTC MONOGRAPH FINAL part358H Geiss, Destin & Dunn, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 50804-316_af8872b1-1893-4545-9739-67ec4d86564a 50804-316 HUMAN OTC DRUG Severe Cold and Cough Relief Daytime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20160731 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 50804-318_876c75bc-54ff-4012-91fc-088d081c8082 50804-318 HUMAN OTC DRUG Antiseptic Eucayptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19900915 OTC MONOGRAPH NOT FINAL part356 Geiss, Destin & Dunn, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 50804-337_7db6bcd5-7b35-4d08-8e83-efd043c4e1c9 50804-337 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20160930 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 50804-352_5013d592-d61d-4096-87f9-4d117e5acb16 50804-352 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20131011 ANDA ANDA201745 Good Sense RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 50804-360_f90b22eb-3e90-473a-be0d-ebaec6894128 50804-360 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20121019 OTC MONOGRAPH FINAL part338 Geiss, Destin & Dunn, Inc (Goodsense) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 50804-370_14dc02e5-6e16-451f-8207-3273515e3f7d 50804-370 HUMAN OTC DRUG Enteric coated aspirin Regular strength Aspirin TABLET, COATED ORAL 20110822 OTC MONOGRAPH FINAL part343 Good Sense (Geiss, Destin & Dunn, Inc.) ASPIRIN 325 mg/1 N 20181231 50804-376_e129b1e8-0304-4879-b27a-7918dd83fdf7 50804-376 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20140930 OTC MONOGRAPH NOT FINAL part356 Good Sense (Geiss, Destin & Dunn, Inc.) PHENOL 1.5 g/100mL N 20181231 50804-377_8dbd84fc-2e6a-4bd5-9dc7-424838c61875 50804-377 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20140930 OTC MONOGRAPH NOT FINAL part356 Good Sense (Geiss, Destin & Dunn, Inc.) PHENOL 1.5 g/100mL N 20181231 50804-390_c4869d96-2422-4977-bc01-85eece2ecedb 50804-390 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20160930 OTC MONOGRAPH FINAL part347 Good Sense (Geiss, Destin & Dunn, Inc.) WITCH HAZEL 842 mg/mL N 20181231 50804-392_1ea5f150-3375-43ff-965e-5077f8349953 50804-392 HUMAN OTC DRUG Itchy Eye Drops Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140620 ANDA ANDA077958 Good Sense KETOTIFEN FUMARATE .35 mg/mL N 20181231 50804-403_aded0a0c-b370-4ac0-aed8-4c1d55ed0b78 50804-403 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333A Geiss, Destin & Dunn, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 50804-468_e7630ae2-45fa-4941-bac1-f6b14cf527a5 50804-468 HUMAN OTC DRUG Daytime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20150831 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 50804-469_33c29000-5c05-00b3-e054-00144ff8d46c 50804-469 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen TABLET ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 GoodSense ACETAMINOPHEN 325 mg/1 N 20181231 50804-470_5dfa2691-df89-400b-bc5b-17310269f068 50804-470 HUMAN OTC DRUG Daytime cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20110729 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 50804-473_33c29000-5c30-00b3-e054-00144ff8d46c 50804-473 HUMAN OTC DRUG Severe Allergy Relief Plus Sinus Headache ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110331 OTC MONOGRAPH FINAL part341 GoodSense ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 50804-476_33c2a84c-1f09-0ee8-e054-00144ff8d46c 50804-476 HUMAN OTC DRUG Pressure plus Pain PE ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20110331 OTC MONOGRAPH FINAL part341 GoodSense ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 50804-480_08c3494d-6498-4cfb-94b8-baa960104745 50804-480 HUMAN OTC DRUG Nighttime cold and flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120701 OTC MONOGRAPH FINAL part341 Geiss, Destin & Dunn, Inc (Goodsense) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 50804-483_10d4bfb3-0274-47b2-9848-e7a95fecc79c 50804-483 HUMAN OTC DRUG Allergy Relief Dye Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part341 Good Sense (Geiss, Destin & Dunn, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50804-484_d9668183-00f4-47ab-8269-bf38733b2fd0 50804-484 HUMAN OTC DRUG Stimulant Laxative Plus Stool Softener Docusate sodium, Sennosides TABLET ORAL 20151031 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 50804-486_f2393f34-e5d3-40ad-9303-632a9757fa31 50804-486 HUMAN OTC DRUG Senna laxative Sennosides TABLET ORAL 20160331 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) SENNOSIDES 8.6 mg/1 N 20181231 50804-492_fd8102ec-3388-444f-9918-13efccbc7d2d 50804-492 HUMAN OTC DRUG Laxative pills Maximum Strength Sennosides TABLET ORAL 20160731 OTC MONOGRAPH NOT FINAL part334 Good Sense (Geiss, Destin & Dunn, Inc.) SENNOSIDES 25 mg/1 N 20181231 50804-520_8fc69b8e-642a-49cd-b3fe-257fbe3a00fb 50804-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100715 NDA NDA021855 Good Sense (Geiss, Destin & Dunn, Inc.) LOPERAMIDE HYDROCHLORIDE 2 mg/1 E 20171231 50804-525_cc95db7b-a6fc-46f6-a1d0-4698c2234258 50804-525 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20160831 OTC MONOGRAPH NOT FINAL part343 Good Sense (Geiss, Destin & Dunn, Inc.) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 50804-551_33c29000-5c67-00b3-e054-00144ff8d46c 50804-551 HUMAN OTC DRUG Cold Multi-Symptom Daytime and Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride KIT 20111231 OTC MONOGRAPH FINAL part341 GoodSense N 20181231 50804-554_33c29000-5c49-00b3-e054-00144ff8d46c 50804-554 HUMAN OTC DRUG Sinus plus Headache Daytime and Nighttime Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride KIT 20111231 OTC MONOGRAPH FINAL part341 GoodSense N 20181231 50804-620_9d971b5b-fe9e-4bee-9f08-046535e31fea 50804-620 HUMAN OTC DRUG Motion sickness less drowsy formula Meclizine HCl TABLET ORAL 20120319 OTC MONOGRAPH FINAL part336 Good Sense (Geiss, Destin & Dunn, Inc.) MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 50804-630_f87fcc88-8d38-48d7-8185-b19cae8200c7 50804-630 HUMAN OTC DRUG Motion Sickness Original Formula Dimenhydrinate TABLET ORAL 20100810 OTC MONOGRAPH FINAL part336 Good Sense (Geiss, Destin & Dunn, Inc.) DIMENHYDRINATE 50 mg/1 N 20181231 50804-664_5497f748-26e3-4b06-811d-be09f5145a78 50804-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19921001 OTC MONOGRAPH NOT FINAL part356 Geiss, Destin & Dunn, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 50804-667_8adce681-ea87-4c40-9301-10f6abec63b5 50804-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20090518 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 50804-672_33c29000-5c19-00b3-e054-00144ff8d46c 50804-672 HUMAN OTC DRUG Sinus Severe ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130630 OTC MONOGRAPH FINAL part341 GoodSense ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 50804-686_d2a305ed-1422-4516-9a67-74a1f484b8d0 50804-686 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20090518 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 50804-693_68709175-bae8-450d-b33b-654fd081a75e 50804-693 HUMAN OTC DRUG citroma Magesium Citrate SOLUTION ORAL 20090518 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 50804-720_88f468ff-2727-45f3-a2b3-f4ff2029f337 50804-720 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130606 OTC MONOGRAPH FINAL part336 Good Sense (Geiss, Destin & Dunn, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50804-748_18b99920-b01b-4c74-8442-6015542e51d6 50804-748 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid LIQUID TOPICAL 20150810 OTC MONOGRAPH FINAL part358B Geiss Destin & Dunn Inc. SALICYLIC ACID .17 g/9mL N 20181231 50804-749_846095df-e701-4c8f-9f00-cfffe6bbdb6d 50804-749 HUMAN OTC DRUG Salicylic Acid Corn and Callus Remover LIQUID TOPICAL 20150810 OTC MONOGRAPH FINAL part358B Geiss, Destin & Dunn, Inc. SALICYLIC ACID .17 g/9.8mL N 20181231 50804-777_94b2a4f8-7a3b-4f65-be19-a64f0b6a7cb1 50804-777 HUMAN OTC DRUG Ear Drops Major Carbamide Peroxide 6.5% LIQUID AURICULAR (OTIC) 20170901 OTC MONOGRAPH FINAL part344 Good Sense CARBAMIDE PEROXIDE 6.5 g/100mL N 20181231 50804-778_5accb79a-83a1-4597-b247-b8e39ccc8c24 50804-778 HUMAN OTC DRUG Goodsense Maximum Strength Redness Relief Plus Glycerin, and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20160105 OTC MONOGRAPH FINAL part349 Good Sense (Geiss, destin & dunn, Inc.) GLYCERIN; NAPHAZOLINE HYDROCHLORIDE .00015; .0025 mg/mL; mg/mL N 20181231 50804-779_87044ddd-0688-4685-9a09-37ca2477a0be 50804-779 HUMAN OTC DRUG Goodsense Diaper Rash Zinc Oxide PASTE ORAL 20160105 OTC MONOGRAPH FINAL part347 Geiss, Destin & Dunn, Inc. ZINC OXIDE 400 mg/g E 20171231 50804-780_602d5713-f692-17cc-e053-2a91aa0a2d77 50804-780 HUMAN OTC DRUG Goodsense Sensitive Extra Whitening Potassium Nitrate, and Sodium Fluroide PASTE ORAL 20151229 OTC MONOGRAPH NOT FINAL part356 Geiss, Destin & Dunn, Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 50804-803_33c29000-5c87-00b3-e054-00144ff8d46c 50804-803 HUMAN OTC DRUG Pressure plus Pain PE plus Cough ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20160530 OTC MONOGRAPH FINAL part341 GoodSense ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 50804-804_5a355200-f3a3-44d4-9523-e87c6d227508 50804-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20110422 OTC MONOGRAPH NOT FINAL part333A Geiss,Destine & Dunn, Inc ISOPROPYL ALCOHOL .91 mg/mL N 20181231 50804-805_33c29000-5cb2-00b3-e054-00144ff8d46c 50804-805 HUMAN OTC DRUG Cold and Head Congestion Severe ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20160530 OTC MONOGRAPH FINAL part341 GoodSense ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 50804-810_4a4f8abb-2d74-4bdb-a8c1-e5dba3ea1c8c 50804-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20100408 OTC MONOGRAPH NOT FINAL part333A Geiss, Destin & Dunn, Inc ISOPROPYL ALCOHOL 500 mg/mL N 20181231 50804-819_7495bcb1-f40b-44bb-9799-4e260dd4117a 50804-819 HUMAN OTC DRUG Goodsense First Aid Antibiotic Polymyxin B, and Bacitracin Zinc OINTMENT TOPICAL 20170815 OTC MONOGRAPH FINAL part333B Geiss, Destin & Dunn, Inc POLYMYXIN B SULFATE; BACITRACIN ZINC 10000; 500 [USP'U]/g; [USP'U]/g N 20181231 50804-821_08be22d8-4f39-44e3-96e8-61e7fb073fc4 50804-821 HUMAN OTC DRUG Goodsense Ultra Lubricant Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20170518 OTC MONOGRAPH FINAL part349 Geiss, Destin & Dunn, Inc POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 50804-822_7c6b7bb5-e6b9-4159-82fc-cc945ed32b06 50804-822 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20110422 OTC MONOGRAPH FINAL part346 Geiss, Destin & Dunn WITCH HAZEL 979 mg/mL N 20181231 50804-825_5955a239-7296-7ba2-e053-2991aa0a4e1c 50804-825 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20170801 OTC MONOGRAPH FINAL part341 GoodSense ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 50804-826_59547479-c196-28ea-e053-2a91aa0a7b5f 50804-826 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20170801 OTC MONOGRAPH NOT FINAL part343 GoodSense ACETAMINOPHEN 500 mg/1 N 20181231 50804-828_59b9d247-4e85-54a3-e053-2a91aa0a1ad1 50804-828 HUMAN OTC DRUG Allergy Multi-Symptom ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20170801 OTC MONOGRAPH FINAL part341 Goodsense ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 50804-831_aec35b51-c3ed-4b7d-a588-3aef7f483eba 50804-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19940805 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc MINERAL OIL 999 mg/mL N 20181231 50804-845_fe8abad0-588a-4209-9c85-af26523156a3 50804-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20110422 OTC MONOGRAPH FINAL part344 Geiss, Destin & Dunn, Inc ISOPROPYL ALCOHOL 613 mg/mL N 20181231 50804-864_122c1a1f-1af7-4a3b-b601-07bb8f4fab65 50804-864 HUMAN OTC DRUG 50% Rubbing Isopropyl Alcohol LIQUID TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333A Geiss, Destin & Dunn, Inc ISOPROPYL ALCOHOL 500 mg/mL N 20191231 50804-871_921458c0-ae04-45b9-980e-1a88cd20b87b 50804-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19920615 OTC MONOGRAPH NOT FINAL part333A Geiss, Destin & Dunn, Inc HYDROGEN PEROXIDE 30 mg/mL N 20181231 50804-876_389f0176-5420-4e80-87a5-33e06eeba65b 50804-876 HUMAN OTC DRUG Rubbing Ethyl Alcohol LIQUID TOPICAL 20090518 OTC MONOGRAPH NOT FINAL part333A Geiss, Destin & Dunn, Inc ALCOHOL 610 mg/mL N 20181231 50809-001_54ea526f-516a-495e-84c8-3f9273d26637 50809-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100517 UNAPPROVED MEDICAL GAS Abilene Oxygen Inc. OXYGEN 99 L/100L E 20171231 50810-1000_f4605910-cddc-4773-b92a-eceb10bc5d65 50810-1000 HUMAN OTC DRUG Dr. JIs Arthritis Plus camphor, menthol, methyl salicylate GEL TOPICAL 20100504 OTC MONOGRAPH FINAL part348 JI Well Health Company CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3; 12; 15 mg/100mg; mg/100mg; mg/100mg E 20171231 50810-2000_22565752-f20c-44f2-80d0-29261781923d 50810-2000 HUMAN OTC DRUG Arthritis Plus Gel Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 JI Well Health Company CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3; 12; 15 mg/100mg; mg/100mg; mg/100mg N 20181231 50810-3000_87eb17af-3296-4d2d-a222-c87a1df7c2d4 50810-3000 HUMAN OTC DRUG Dr. J.I.s Arthritis Plus Gel Camphor, Menthol, Methyl Salicylate CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 JI Well Health Company CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3; 12; 15 mg/100mg; mg/100mg; mg/100mg N 20181231 50813-0001_661a107f-8ed3-4b69-8c48-775525795dd7 50813-0001 HUMAN OTC DRUG Bacto Plus Baptisia Tinctoria, Echinacea, Phytolacca Decandra, Aconitum Napellus, Arsenicum Album, Belladonna, Ferrum Phosphoricum LIQUID ORAL 20130912 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale, Chiropractic Life Center BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; PHYTOLACCA AMERICANA ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50813-0002_00269ef8-664b-47c7-9351-ed553c536595 50813-0002 HUMAN OTC DRUG Bacto Plus HP Apis Mellifica, Arsenicum Album, Belladonna, Chamomilla, Echinacea, Lachesis Mutus, Mercurius Solubilis, Pulsatilla, Pyrogenium LIQUID ORAL 20130912 20191117 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale, Chiropractic Life Center APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50813-0003_9f9026ca-72bf-41f7-8adf-abfc22bde311 50813-0003 HUMAN OTC DRUG Viro Plus Echinacea, Hydrastis Canadensis, Lomatium, Aconitum napellus, Arsenicum Album, Belladonna, Epatorium Perfoliatum, Gelsemium Sempervirens LIQUID ORAL 20130912 20190821 UNAPPROVED HOMEOPATHIC Dr. Elena Morreale, Chiropractic Life Center ECHINACEA, UNSPECIFIED; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; TOXICODENDRON PUBESCENS LEAF; RANCID BEEF 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50813-0004_61625dde-bb4a-4458-84ad-2d1dc1c768fe 50813-0004 HUMAN OTC DRUG Fungal Plus Candida Albicans LIQUID ORAL 20130912 20190820 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale, Chiropractic Life Center CANDIDA ALBICANS 6 [hp_X]/mL N 20181231 50813-0005_9a0cc81c-940b-4ff5-9792-1dcae6cd8e18 50813-0005 HUMAN OTC DRUG Lymph Plus Geranium Robertianum, Nasturtium Aquaticum, Aloe Socotrina, Juglans Regia, Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia LIQUID ORAL 20130912 20190501 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale, Chiropractic Life Center GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; ALOE; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; VERONICA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; SARSAPARILLA; BARIUM CARBONATE; CALCIUM SULFIDE; MERCURIC CYANIDE; FERROUS IODIDE; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; THYROID, PORCINE 3; 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50813-0006_e9e68f26-c78e-4248-afdc-0a97e9fc2391 50813-0006 HUMAN OTC DRUG Bacto Plus Baptisia tinctoria, Echinacea (Angustifolia), Phytolacca decandra, Aconitum napellus, Arsenicum album, Belladonna, Ferrum phosphoricum, Lachesis mutus, Phosphorus LIQUID ORAL 20140602 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50813-0007_f5228c65-2b9e-4f67-8f89-84474498a634 50813-0007 HUMAN OTC DRUG Lymph Plus Geranium robertianum, Nasturtium aquaticum, Aloe socotrina, Myosotis arvensis, Scrophularia nodosa, Teucrium socorodonia, Apis mellifica, Equisetum hyemale, Fumaria officinalis, Natrum sulphuricum, Phytolacca decandra, Pinus sylvestris, Veronica officinalis, Gentiana lutea, Juglans ragia, Sarsaparilla, Baryta carbonica, Hepar sulphuris calcareum, Mercurius cyanatus, Ferrum iodatun, Aranea diadema, Calcarea phosphorica, Parathyroid (Bovine), Thymus (Suis), Thyroidinum (Suis) LIQUID ORAL 20140621 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale GERANIUM ROBERTIANUM; NASTURTIUM AQUATICUM; ALOE; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; VERONICA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; SARSAPARILLA; BARIUM CARBONATE; CALCIUM SULFIDE; MERCURIC CYANIDE; FERROUS IODIDE; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; BOS TAURUS PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 5; 5; 5; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50813-0008_884b2d94-8932-451f-958f-5c05d2450dea 50813-0008 HUMAN OTC DRUG Fungal Plus Candida albicans LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC Dr Elena Morreale CANDIDA ALBICANS 12 [hp_X]/mL N 20181231 50813-0009_07761984-a6fd-4057-9a14-b80f74421193 50813-0009 HUMAN OTC DRUG VIRO PLUS NOT APPLICABLE LIQUID ORAL 20140902 UNAPPROVED HOMEOPATHIC Dr Elena M Morreale ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; TOXICODENDRON PUBESCENS LEAF; RANCID BEEF 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50813-0010_d3cd4436-b4e5-460b-8b9c-94630008c3de 50813-0010 HUMAN OTC DRUG BACTO PLUS HP APIS MELLIFERA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS LIQUID ORAL 20141208 UNAPPROVED HOMEOPATHIC Dr. Elena M. Morreale, Chiropractic Life Center APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50814-001_61061f3b-2732-8a04-e053-2a91aa0a32bf 50814-001 HUMAN OTC DRUG Alcohol Cleansing ISOPROPYL ALCOHOL SWAB TOPICAL 20160322 OTC MONOGRAPH NOT FINAL part333A GFA Production (Xiamen) Co., Ltd. ISOPROPYL ALCOHOL 700 mg/g N 20181231 50814-002_61061f3b-2740-8a04-e053-2a91aa0a32bf 50814-002 HUMAN OTC DRUG Antiseptic Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20160322 OTC MONOGRAPH NOT FINAL part333A GFA Production (Xiamen) Co., Ltd. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 50814-007_6106f7b0-edb0-d46e-e053-2991aa0a959e 50814-007 HUMAN OTC DRUG First Aid Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE OINTMENT TOPICAL 20160701 OTC MONOGRAPH FINAL part333B GFA Production (Xiamen) Co., Ltd. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 50814-008_6106f7b0-edbe-d46e-e053-2991aa0a959e 50814-008 HUMAN OTC DRUG Antiseptic Hand Sanitizer ALCOHOL GEL TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part333E GFA Production (Xiamen) Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 50814-009_6106f7b0-edcb-d46e-e053-2991aa0a959e 50814-009 HUMAN OTC DRUG First Aid Antiseptic Pain Relieving BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part333A GFA Production (Xiamen) Co., Ltd. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 1.3 mg/g; mg/g N 20181231 50816-624_3a3aa611-f531-489a-99c7-2fbad3b04f86 50816-624 HUMAN PRESCRIPTION DRUG Denavir penciclovir CREAM TOPICAL 20101229 NDA NDA020629 New American Therapeutics, Inc PENCICLOVIR 10 mg/g DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 50825-001_b3256bb7-338d-4b08-b64c-36b837329a26 50825-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS Zurcare dba Reliable Medical OXYGEN 99 L/100L E 20171231 50827-002_2910b512-cc87-449b-9529-5e72528df5a3 50827-002 HUMAN OTC DRUG Comfort Alcohol LIQUID TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A WEIMEI Lianyungang HOUSEHOLD ARTICLES MANUFACTURING CO.LTD ISOPROPYL ALCOHOL 50 mL/100mL E 20171231 50827-003_88a40cba-e159-4f6e-b8e8-0c7db59769c6 50827-003 HUMAN OTC DRUG Comfort Alcohol LIQUID TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A WEIMEI Lianyungang Household Articles Manufacturing Co. LTD ISOPROPYL ALCOHOL 50 mL/100mL E 20171231 50827-650_212d5763-a0ff-4f94-9437-c085502ab098 50827-650 HUMAN OTC DRUG COMFORT HYDROGEN PEROXIDE LIQUID TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part333A Weimei Lianyungang Household Articles manufacturing, Co. LTD HYDROGEN PEROXIDE 2.65 mL/100mL E 20171231 50844-004_7181c51e-fe2d-4a39-902c-9c9f4a784340 50844-004 HUMAN OTC DRUG Severe Congestion and Cough Relief Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20170301 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 50844-005_917f77ab-8d4a-4acd-bd59-5c77729be996 50844-005 HUMAN OTC DRUG Cold, Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20170301 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 50844-009_001f34da-7cb0-46eb-acd3-bf0099c64bd4 50844-009 HUMAN OTC DRUG Multi-Symptom Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20170301 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 50844-112_a59ab13b-8103-4a02-8d58-f983da1135ca 50844-112 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19810825 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 50844-157_32b93716-1fd6-434a-b0a1-a056b15c451f 50844-157 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ASPIRIN 325 mg/1 N 20181231 50844-159_2a9f7679-6283-4597-9c09-451276c12856 50844-159 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 50844-175_b6a5644e-30a9-4e7a-b8c7-0c4ca6eb394a 50844-175 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN 500 mg/1 N 20191231 50844-185_ba65fb1e-e188-490f-9fe3-770af93a6401 50844-185 HUMAN OTC DRUG Childrens Chewable Pain Reliever Acetaminophen TABLET, CHEWABLE ORAL 19900410 20200829 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN 80 mg/1 N 20191231 50844-190_8f6ffc33-1ea4-432b-843a-d0339fbb654f 50844-190 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50844-199_71ef9753-2bb9-4825-847d-72748c75ed88 50844-199 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 L.N.K. International, Inc. DIMENHYDRINATE 50 mg/1 N 20181231 50844-218_a5f60a33-157c-45ab-84e3-8acc4bcceaa2 50844-218 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ASPIRIN 81 mg/1 N 20181231 50844-226_0ed30910-b289-49c7-83c5-dd7ebedcfba6 50844-226 HUMAN OTC DRUG Alert Alertness Aid Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 L.N.K. International, Inc. CAFFEINE 200 mg/1 N 20181231 50844-227_c54576dd-5437-4e62-b72f-c1b10eea74a0 50844-227 HUMAN OTC DRUG Enteric Aspirin Regular Strength Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ASPIRIN 325 mg/1 N 20181231 50844-235_af54bd5b-9bd4-47f4-9955-982dde343590 50844-235 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 50844-249_2e34b757-251e-4c19-a6e4-ccd2e78678c2 50844-249 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ASPIRIN 325 mg/1 N 20181231 50844-291_a73a7cd7-3000-45de-bb82-33c3abafbc9d 50844-291 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 L.N.K. International, Inc. IBUPROFEN 200 mg/1 N 20181231 50844-292_2e2bd7b2-9ed2-446a-b4e3-f42cb418118e 50844-292 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 L.N.K. International, Inc. IBUPROFEN 200 mg/1 N 20181231 50844-293_82ba4121-1a06-4ad7-8169-6284162fbfc4 50844-293 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20040408 20180609 OTC MONOGRAPH FINAL part336 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 E 20171231 50844-327_58eda59e-f7af-4f30-8eea-4ba5b086c04f 50844-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET, COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 L.N.K. International, Inc. BISACODYL 5 mg/1 N 20181231 50844-329_7731ddc3-59ea-41cd-a199-a0ef77a94bc7 50844-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, FILM COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50844-334_a39330e6-c0e5-4e0e-8afa-b88a46fb44d9 50844-334 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 50844-338_3cf392aa-63f9-4eec-995f-5358d1940154 50844-338 HUMAN OTC DRUG Backache Relief Extra Strength Magnesium Salicylate Tetrahydrate TABLET, FILM COATED ORAL 19981107 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. MAGNESIUM SALICYLATE 580 mg/1 N 20181231 50844-348_af840d4f-f199-4d96-a362-66fab1bbe1fd 50844-348 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET, SUGAR COATED ORAL 20030104 OTC MONOGRAPH NOT FINAL part334 L.N.K. International, Inc. SENNOSIDES 25 mg/1 N 20181231 50844-352_23aeb795-2388-42cc-9ca3-31a903eda8a5 50844-352 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 L.N.K. International, Inc. IBUPROFEN 200 mg/1 N 20181231 50844-353_395a077a-1021-4749-a87a-86cdbdb3103b 50844-353 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 L.N.K. International, Inc. IBUPROFEN 200 mg/1 N 20181231 50844-367_9346a885-c074-4338-9a1c-bf99b52a640c 50844-367 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50844-375_1c5e21e5-f802-4ad2-81ed-f25e7c5d54ed 50844-375 HUMAN OTC DRUG Anti-diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 L.N.K. International, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 50844-390_628c5d73-4327-4d64-96c2-ca781143a34c 50844-390 HUMAN OTC DRUG Menstrual Complete Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET, FILM COATED ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 50844-392_4816217c-4fac-424b-8e2a-7e92e1c122f4 50844-392 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 L.N.K. International, Inc. IBUPROFEN 200 mg/1 N 20181231 50844-393_10821ba5-743c-4076-a423-2aa14d2311b3 50844-393 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 L.N.K. International, Inc. IBUPROFEN 200 mg/1 N 20181231 50844-403_2805940d-ff89-478e-8351-ea49d56eb559 50844-403 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 L.N.K. International, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 50844-411_97bdd7b0-f779-43ef-b986-59b47a5b8538 50844-411 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr TABLET, SUGAR COATED ORAL 20030503 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 50844-413_40cd1198-a42b-4662-9017-59416e156392 50844-413 HUMAN OTC DRUG Back and Body Extra Strength Aspirin, Caffeine TABLET, FILM COATED ORAL 20040412 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 N 20181231 50844-417_862db3bf-5229-4ec9-ac0f-443248722f81 50844-417 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20170201 ANDA ANDA204872 L.N.K. International, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 50844-428_2cf37f83-4439-411f-aab3-71090bff5ce2 50844-428 HUMAN OTC DRUG Tension Headache Relief Aspirin Free Acetaminophen, Caffeine TABLET, FILM COATED ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 50844-438_0c564739-bdbd-4ce9-b2bf-16b9e7d861b2 50844-438 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 L.N.K. International, Inc. IBUPROFEN 200 mg/1 N 20181231 50844-444_cead86cf-37a0-4efe-a622-3789f4b78b0a 50844-444 HUMAN OTC DRUG Nasal Decongestant PE Maximum Strength Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 50844-455_2ea47ea3-cbfa-4091-8418-0a05ade673dc 50844-455 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20050628 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 50844-466_811d9898-a6fa-41b3-90a8-fbbfb45cf0f9 50844-466 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Acetaminophen and Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 20190810 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 50844-467_020aedc0-d8ec-48e7-97d5-4fb906ada6f1 50844-467 HUMAN OTC DRUG Sinus and Headache Daytime Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 50844-470_da615659-b1d4-4625-99ad-83feffb3fd0b 50844-470 HUMAN OTC DRUG Multi-Symptom Cold Relief Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20050715 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 50844-519_384ca899-8f66-4942-b1d2-2de2aef4c261 50844-519 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 50844-527_f5d2861b-d449-4156-95cd-3ac1ddd00eb1 50844-527 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Non-Drowsy Severe Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET ORAL 20050806 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 50844-529_1e6a362e-c679-4993-a3b4-e825312e6718 50844-529 HUMAN OTC DRUG Cold Relief Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. N 20181231 50844-529_d5729af5-a440-43ba-a8d2-72ce539a3965 50844-529 HUMAN OTC DRUG Cold Relief Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. N 20181231 50844-546_aae426fe-3b39-45a1-8dff-6bdcaae55215 50844-546 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH FINAL part338 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 50844-548_0b378680-b1d0-4e15-91e8-cae897dba7ea 50844-548 HUMAN OTC DRUG Sinus Relief PE Maxium Strength Guaifenesin, Phenylephrine HCl TABLET ORAL 20030917 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 200; 5 mg/1; mg/1 N 20181231 50844-556_04251797-2db7-459c-a461-3b13a621d730 50844-556 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 50844-563_b4cac0ca-daec-4e95-ab96-7ce7bb2b6d63 50844-563 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ASPIRIN 81 mg/1 N 20181231 50844-578_3c825529-20e2-46cc-bd74-a3c34118b4fb 50844-578 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine HCl TABLET, CHEWABLE ORAL 20081031 ANDA ANDA078692 L.N.K. International, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 50844-600_f0e9db07-cdb8-4384-aa7f-c4619a7b6df5 50844-600 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ASPIRIN 81 mg/1 N 20181231 50844-604_862db3bf-5229-4ec9-ac0f-443248722f81 50844-604 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20170201 ANDA ANDA204872 L.N.K. International, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 50844-607_7348e522-d57e-4c19-9778-4789edfb81e3 50844-607 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET, SUGAR COATED ORAL 20130401 OTC MONOGRAPH NOT FINAL part334 L.N.K. International, Inc. BISACODYL 5 mg/1 N 20181231 50844-611_9aa2c9ad-3bd8-4aea-94de-c727d58d6cb5 50844-611 HUMAN OTC DRUG Ibuprofen PM Diphenhydramine hydrochloride, ibuprofen CAPSULE, LIQUID FILLED ORAL 20130708 ANDA ANDA200888 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 N 20181231 50844-619_8d290b82-312d-4b20-835e-1d3ac4a5d12f 50844-619 HUMAN OTC DRUG Regular Strength Acid Reducer Ranitidine TABLET ORAL 20130615 20180715 ANDA ANDA200536 L.N.K. International, Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 E 20171231 50844-620_6957ac25-8efe-477a-8212-fa61d709cc17 50844-620 HUMAN OTC DRUG Maximum Strength Acid Reducer Ranitidine TABLET ORAL 20130615 20180715 ANDA ANDA200536 L.N.K. International, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 E 20171231 50844-626_e35053e6-e026-40c1-a88a-763d21eafe85 50844-626 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20130422 20180827 OTC MONOGRAPH NOT FINAL part334 L.N.K. International, Inc. DOCUSATE SODIUM 100 mg/1 E 20171231 50844-655_c4185a8b-f6e2-4d47-8326-72c9fe915416 50844-655 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH NOT FINAL part334 L.N.K. International, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 50844-656_d63bff41-4904-403b-8177-be8a1a39caaa 50844-656 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part338 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 50844-659_89d98b2a-36d1-4c25-899d-3fbdfe77b9a8 50844-659 HUMAN OTC DRUG Cold and Flu Relief Daytime, Multi-Symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 50844-660_02224cff-c2a6-4a25-88a4-4bbc557955c5 50844-660 HUMAN OTC DRUG Cold and Flu Relief Nighttime, Multi-Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 50844-663_7222be95-fe8d-45a2-8938-14e30a596e0d 50844-663 HUMAN OTC DRUG Sinus and Congestion Relief Daytime Acetaminophen, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 50844-664_ba1db3af-3c19-46b8-aaf1-dcc7f010a760 50844-664 HUMAN OTC DRUG Sinus Congestion and Pain Relief Non-Drowsy Acetaminophen and Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 50844-670_59faa251-789a-42f1-9101-1820c30cb4ee 50844-670 HUMAN OTC DRUG Cold and Flu Relief Multi-Symptom, Day, Night Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl KIT 20150301 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. N 20181231 50844-675_604a60bc-fee3-4605-ba42-4f945a8e3f9d 50844-675 HUMAN OTC DRUG Aspi-Cor Aspirin TABLET, COATED ORAL 20150203 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ASPIRIN 81 mg/1 N 20181231 50844-676_77e082e5-559e-45f0-8ea6-c8832e9820ab 50844-676 HUMAN OTC DRUG Gentle Laxative WOMENS Bisacodyl TABLET, COATED ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 L.N.K. International, Inc. BISACODYL 5 mg/1 N 20181231 50844-679_e4cd1485-50b1-43f5-a144-4cc8ea93f91c 50844-679 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Pamabrom, Pyrilamine maleate TABLET, FILM COATED ORAL 20150113 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 50844-689_0e43a9c7-ae48-490a-b4cb-665ed46cf992 50844-689 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr TABLET, FILM COATED ORAL 20170331 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 50844-732_2d143d62-b2a7-45d1-a671-17b0b95615f5 50844-732 HUMAN OTC DRUG Ibuprofen PM Ibuprofen and Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20120305 ANDA ANDA200888 LNK International, Inc. IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE 200; 25 mg/1; mg/1 E 20171231 50844-733_f8151108-2078-48fd-bbd9-80b2b028a77f 50844-733 HUMAN OTC DRUG Mucus Relief Cough Dextromethorphan HBr and Guaifenesin TABLET ORAL 20051231 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20191231 50844-735_b105fb84-6d66-4f9b-b522-6c42b6c01d0b 50844-735 HUMAN OTC DRUG Loperamide HCl Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 L.N.K. International, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 50844-751_76450f29-d87a-402a-b087-db64dd8823ab 50844-751 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 50844-753_e0b57c34-a330-4b4b-8cf8-8fc55bd49e1c 50844-753 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 L.N.K. International, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 50844-921_db1a081e-0e9f-4c31-848c-6c195fbbbe9b 50844-921 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 L.N.K. International, Inc. IBUPROFEN 200 mg/1 N 20181231 50844-930_43017146-048c-40d5-8243-49a9b5548810 50844-930 HUMAN OTC DRUG Menstrual Complete Maximum Strength Acetaminophen, Caffeine, Pyrilamine maleate TABLET, FILM COATED ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 50844-932_378a1cb0-5e9b-4aa5-a24f-f4d4073cb617 50844-932 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 50844-948_e68e42f2-50db-4896-b9ed-84de77850a1a 50844-948 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET ORAL 20030102 OTC MONOGRAPH NOT FINAL part334 L.N.K. International, Inc. SENNOSIDES 25 mg/1 N 20181231 50844-951_3fe055e5-ec30-4137-86d3-8dca5faeaf8a 50844-951 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 50844-953_9715c286-addd-4819-842c-a72687babfd4 50844-953 HUMAN OTC DRUG Nasal Decongestant PE Maximum Strength Non Drowsy Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 L.N.K. International, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 50844-956_bc79cfbb-fddb-45c0-8e07-93de0b7d6ed6 50844-956 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 50844-957_812414af-e4c6-40a4-97e6-acf929cf5331 50844-957 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 L.N.K. International, Inc. ASPIRIN 325 mg/1 N 20181231 50844-964_6a052f45-9d89-44a4-8319-97fe90339e2f 50844-964 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part332 L.N.K. International, Inc. DIMETHICONE 125 mg/1 N 20181231 50844-993_907e7944-5138-49c4-9d55-9ac16c8df205 50844-993 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19990301 ANDA ANDA075139 L.N.K. International, Inc. IBUPROFEN 200 mg/1 N 20181231 50845-0002_55762780-6126-42e2-9631-95b71f30a632 50845-0002 HUMAN OTC DRUG Venapro Venapro SPRAY ORAL 20100512 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. HORSE CHESTNUT; ARNICA MONTANA; CALCIUM FLUORIDE; SILYBUM MARIANUM SEED; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT 1; 3; 10; 1; 3; 1; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0003_08607ee9-3e92-4a09-b8ae-effde3bbe5be 50845-0003 HUMAN OTC DRUG Wartrol Antimoniom crudum, Baptisia tinctoria, Causticum, Nitricum acidum, Thuja occidentalis, SPRAY ORAL 20100916 UNAPPROVED HOMEOPATHIC Liddell Laboratories ANTIMONY TRISULFIDE; BAPTISIA TINCTORIA ROOT; CAUSTICUM; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG 30; 3; 200; 200; 200 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 50845-0015_7ce14dbc-92cd-46a1-8c82-e8b213fdef9f 50845-0015 HUMAN OTC DRUG ProBlen HGH HGH, Hepar bovinum, Pituitary bovinum, SPRAY ORAL 20110126 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. SOMATROPIN; BEEF LIVER; BOS TAURUS PITUITARY GLAND 30; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0016_2624391d-3736-43a8-866b-3662670e7766 50845-0016 HUMAN OTC DRUG HGH Complex Arnica montana, Carduus marianus, SPRAY ORAL 20100512 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; SILYBUM MARIANUM SEED; ASIAN GINSENG; PORK LIVER; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND 3; 1; 1; 3; 3; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0017_586b3c0a-e19c-4e33-93c8-4d543d4e56d7 50845-0017 HUMAN OTC DRUG Vaginitis Baptisia tinctoria, Kreosotum, Mercurius iodatus ruber, Mercurius sulphuratus ruber, Nitricum acidum, Platinum metallicum, Sulphur iodatum, Thymus suis SPRAY ORAL 20110113 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BAPTISIA TINCTORIA ROOT; WOOD CREOSOTE; MERCURIC IODIDE; MERCURIC SULFIDE; NITRIC ACID; PLATINUM; SULFUR IODIDE; SUS SCROFA THYMUS 3; 30; 200; 30; 30; 30; 200; 6 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0018_49c936ae-f06b-4546-8d42-e256e738ffb0 50845-0018 HUMAN OTC DRUG Acne Anthracinum, Antimonium crudum, Hydrocotyle asiatica, Juglans regia, Kali bromatum, Ledum palustre, Natrum sulphuratum, Pyrogenium, Radium bromatum, Sanguinaria canadensis, Sulphur iodatum, Thuja occidentalis, Urtica urens SPRAY ORAL 20110120 20190326 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ANTIMONY TRISULFIDE; CENTELLA ASIATICA; JUGLANS REGIA FLOWERING TOP; POTASSIUM BROMIDE; LEDUM PALUSTRE TWIG; SODIUM SULFIDE NONAHYDRATE; RANCID BEEF; RADIUM BROMIDE; SANGUINARIA CANADENSIS ROOT; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 200; 30; 30; 6; 30; 6; 200; 30; 200; 3; 200; 200; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0019_bbe208ed-f0b9-4f2d-aebe-c5d84a4ac578 50845-0019 HUMAN OTC DRUG Varicose Veins Aesculus hippocastanum, Arnica montana, Calcarea fluorica, Calcarea iodata, Carduus marianus, Hamamelis virginiana, Hepar suis, Hydrofluoricum acidum, Lachesis mutus, Millefolium, Pulsatilla, SPRAY ORAL 20111118 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc HORSE CHESTNUT; ARNICA MONTANA; CALCIUM FLUORIDE; CALCIUM IODIDE; SILYBUM MARIANUM SEED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; ACHILLEA MILLEFOLIUM; PULSATILLA VULGARIS 1; 3; 12; 6; 1; 1; 6; 12; 200; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0021_1c8bae8c-a0a0-47f2-8042-d65b203f4978 50845-0021 HUMAN OTC DRUG Cough and Bronchial Antimonium tartaricum, Arsenicum album, Arsenicum iodatum, Arum triphyllum, Baptisia tinctoria, Bryonia, Drosera, Echinacea, SPRAY ORAL 20100902 UNAPPROVED HOMEOPATHIC Liddell Laboratories ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; ARISAEMA TRIPHYLLUM ROOT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; POTASSIUM BROMIDE; SUS SCROFA LUNG; MERCURIC CHLORIDE; LOBARIA PULMONARIA; SULFUR IODIDE; URTICA URENS 200; 200; 200; 30; 3; 200; 30; 3; 200; 6; 6; 200; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 50845-0023_8f897153-32bb-4b95-b3ef-1314f49a737a 50845-0023 HUMAN OTC DRUG Yeastrol Baptisia tinctoria, Borax, Candida albicans, Candida parasilosis, Echinacea, Kreosotum, Mercurius cyanatus, SPRAY ORAL 20100727 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BAPTISIA TINCTORIA ROOT; SODIUM BORATE; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA; MERCURIC CYANIDE; MERCURIC SULFIDE; NITRIC ACID; RANCID BEEF; SULFURIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTE 3; 30; 12; 12; 3; 30; 30; 30; 200; 30; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 50845-0025_abef38da-7a2c-463d-b7aa-15cf60fc1cb5 50845-0025 HUMAN OTC DRUG Anit-Inflammatory Aconitum napellus, Apis mellifica, Arnica montana, Cartilage porcine, Hydrastis canadensis, Hypericum perforatum, Rhus toxicodendron, Thuja occidentalis, SPRAY ORAL 20100825 UNAPPROVED HOMEOPATHIC Liddell Laboratories ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; SUS SCROFA CARTILAGE; GOLDENSEAL; HYPERICUM PERFORATUM; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG 200; 200; 200; 3; 6; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 50845-0027_9ed29055-30f6-41a5-90fd-7aa684c77bd1 50845-0027 HUMAN OTC DRUG Poison Oak Ivy Agaricus muscarius, Anacardium orientale, Apis mellifica, Croton tiglium, Cypripedium pubescens, Grindelia, Pyrogenium, Rhus toxicodendron, SPRAY ORAL 20111118 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AMANITA MUSCARIA FRUITING BODY; SEMECARPUS ANACARDIUM JUICE; APIS MELLIFERA; CROTON TIGLIUM SEED; CYPRIPEDIUM PARVIFOLUM ROOT; GRINDELIA HIRSUTULA FLOWERING TOP; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 6; 6; 200; 6; 1; 6; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0029_a3071b29-0186-47c1-94b6-6192619659f2 50845-0029 HUMAN OTC DRUG Pain Aconitum Napellus, Arnica Montana, Arsenicum Album, Bellis Perennis, Cartilago Suis, Causticum, Chamomilla, Coffea Cruda, Euphorbium Officinarum, Gnaphalium Polycephalum, Hypericum Perforatum, Magnesia Phosphorica, Passiflora Incarnata, Pyrogenium, Ranunculus Bulbosus, Symphytum Officinale SPRAY ORAL 20101028 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BELLIS PERENNIS; SUS SCROFA CARTILAGE; CAUSTICUM; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; EUPHORBIA RESINIFERA RESIN; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PASSIFLORA INCARNATA TOP; RANCID BEEF; RANUNCULUS BULBOSUS; COMFREY ROOT 200; 3; 200; 3; 6; 200; 3; 200; 4; 3; 200; 12; 1; 200; 3; 6 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0031_580863bc-a3c4-4939-939e-8252c7710101 50845-0031 HUMAN OTC DRUG Allergy Allium cepa, Apis mellifica, Aralia racemosa, Arundo mauritanica, Baptisia tinctoria, Echinacea, Euphrasia officinalis, Gelsemium sempervirens, SPRAY ORAL 20100812 UNAPPROVED HOMEOPATHIC Liddell Laboratories ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; ARUNDO PLINIANA ROOT; BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SANGUINARIA CANADENSIS ROOT; URTICA URENS 6; 3; 6; 30; 3; 4; 6; 200; 12; 6; 200; 6; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0032_e33b0352-eaac-4252-acd1-d780aded2ef7 50845-0032 HUMAN OTC DRUG Jet Lag Anacardium orientale, Apis mellifica, Carbo vegetabilis, Carduus marianus, Cocculus indicus, Kali phosphoricum, Nux vomica, Passiflora incarnata, Phosphoricum acidum, Tabacum, SPRAY ORAL 20110602 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. SEMECARPUS ANACARDIUM JUICE; APIS MELLIFERA; ACTIVATED CHARCOAL; SILYBUM MARIANUM SEED; ANAMIRTA COCCULUS SEED; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA TOP; PHOSPHORIC ACID; TOBACCO LEAF 12; 200; 200; 3; 30; 12; 30; 1; 200; 6 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0034_f51a7d3d-70bd-4ddc-b697-1e3444cfcbea 50845-0034 HUMAN OTC DRUG Nicotine Free Abies Nigra, Aconitum Napellus, Arsenicum Iodatum, Avena Sativa, Ignatia Amara, Lung Suis, Nux Vomica, Plantago Major, Quebracho, Sticta Pulmonaria, Tabacum, LIQUID ORAL 20140110 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. PICEA MARIANA RESIN; ACONITUM NAPELLUS; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; SUS SCROFA LUNG; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; TOBACCO LEAF 10; 200; 200; 1; 200; 6; 10; 3; 3; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0035_4a6605ba-99fe-4ae3-8e9c-6c51a3136678 50845-0035 HUMAN OTC DRUG Vital Female Sexual Energy Agnus Castus, Arnica Montana, Caulophyllum Thalictroides, Cinchona Officinalis, Damiana, Hypophysis Suis, L-Arginine, Lactuca Virosa, Onosmodium Virginianum, Oophorinum Suis, Phosphoricum Acidum, Sepia, Thuja Occidentalis SPRAY ORAL 20100810 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CHASTE TREE; ARNICA MONTANA; CAULOPHYLLUM THALICTROIDES ROOT; CINCHONA OFFICINALIS BARK; TURNERA DIFFUSA LEAFY TWIG; ARGININE; LACTUCA VIROSA; ONOSMODIUM VIRGINIANUM WHOLE; SUS SCROFA OVARY; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 6; 3; 1; 6; 3; 30; 30; 200; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0036_b6e2d5cd-4b39-457d-9aa0-5d299c8fb2da 50845-0036 HUMAN OTC DRUG Extreme GH Arnica montana, Carduus marianus, Hepar suis, Korean ginseng, Phosphoricum acidum, Pituitary suis, SPRAY ORAL 20100823 UNAPPROVED HOMEOPATHIC Liddell Laboratories ARNICA MONTANA; SILYBUM MARIANUM SEED; PORK LIVER; ASIAN GINSENG; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND 1; 1; 4; 1; 1; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0037_d4beb8eb-803b-4ca0-a910-3266e78b0beb 50845-0037 HUMAN OTC DRUG Weight Loss Solution Amino acids, Apis mellifica, Arnica montana, Fucus vesiculosus, Gambogia, Hepar suis, Phosphoricum acidum Pituitary suis, SPRAY ORAL 20100811 UNAPPROVED HOMEOPATHIC Liddell Laboratories AMINO ACIDS; APIS MELLIFERA; ARNICA MONTANA; FUCUS VESICULOSUS; GAMBOGE; PORK LIVER; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA THYROID 6; 4; 3; 3; 3; 6; 3; 24; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 50845-0038_624f5b3e-07c2-49b8-bda7-7a365f1d5678 50845-0038 HUMAN OTC DRUG Vital Male Sexual Energy Arnica montana, Caladium seguinum, Carduus marianus, Damiana, Galium aparine, Glandula suprarenalis suis, Hepar suis, Korean ginseng, SPRAY ORAL 20100810 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc ARNICA MONTANA; DIEFFENBACHIA SEGUINE; SILYBUM MARIANUM SEED; TURNERA DIFFUSA LEAFY TWIG; GALIUM APARINE; SUS SCROFA ADRENAL GLAND; PORK LIVER; ASIAN GINSENG; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; POPULUS TREMULOIDES BARK; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA THYMUS; SUS SCROFA THYROID; SUS SCROFA TESTICLE; LACTUCA VIROSA; NUPHAR LUTEUM ROOT 3; 6; 3; 1; 3; 12; 6; 1; 200; 12; 1; 30; 200; 6; 12; 6; 3; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0039_72b40172-e95c-4eae-8fb5-307378896b16 50845-0039 HUMAN OTC DRUG Extreme Thyro pro Amino acids, Apis mellifica, Arnica montana, Fucus vesiculsus, Gambogia, Hepar suis, Phosphoricum acidum, SPRAY ORAL 20100820 UNAPPROVED HOMEOPATHIC Liddell Laboratories AMINO ACIDS; APIS MELLIFERA; ARNICA MONTANA; FUCUS VESICULOSUS; GAMBOGE; PORK LIVER; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; THYROID 6; 3; 3; 3; 3; 6; 3; 24; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 50845-0041_d16d4dc4-42f2-4136-a45e-422ae76d9e63 50845-0041 HUMAN OTC DRUG Vital HGH Hepar suis, Human Growth Hormone, Pituitary suis, SPRAY ORAL 20100812 UNAPPROVED HOMEOPATHIC Liddell Laboratories PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0042_a3f633cd-6316-4a45-b6a8-fd3ac66f8dea 50845-0042 HUMAN OTC DRUG Brain Energy Arnica montana, Brain suis, Carduus marianus, Cinchona officinalis, Gingko biloba, Lecithin, Millefolium, Phosphoricum acidum, SPRAY ORAL 20100928 UNAPPROVED HOMEOPATHIC Liddell Laboratories ARNICA MONTANA; PORK BRAIN; SILYBUM MARIANUM SEED; CINCHONA OFFICINALIS BARK; GINKGO; EGG PHOSPHOLIPIDS; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID 3; 6; 3; 6; 6; 12; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 50845-0043_d5245aa9-b6ca-43d5-a11d-394689fe2607 50845-0043 HUMAN OTC DRUG Anger Aconitum napellus, Asafoetida, Chamomilla, Crocus sativus, Hyoscyamus niger, Ignatia amara, Sumbul, Valeriana officinalis SPRAY ORAL 20100825 UNAPPROVED HOMEOPATHIC Liddell Laboratories ACONITUM NAPELLUS; ASAFETIDA; MATRICARIA RECUTITA; SAFFRON; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; FERULA SUMBUL ROOT; VALERIAN 200; 4; 3; 3; 200; 4; 3; 3 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0044_4b94b649-34ae-42f0-bcdd-ebdb599efac3 50845-0044 HUMAN OTC DRUG Back Pain and Sciatica Aconitum Napellus, Arnica Montana, Belladonna, Cimicifuga Racemosa, Euphorbium Officinarum, Gelsemium Sempervirens, Gnaphalium Polycephalum, Hypericum Perforatum, Magnesia Phosphorica, Phytolacca Decandra, Ranunculus Bulbosus, Rhus Tox SPRAY ORAL 20110105 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BLACK COHOSH; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 200; 200; 6; 6; 6; 6; 30; 200; 10; 3; 30; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0045_44f1c510-936d-4907-8cdd-618ed771131d 50845-0045 HUMAN OTC DRUG Metals Alumina, Arsenicum Metallicum, Mercurius Corrosivus, Niccolum Metallicum, Plumbum Metallicum, Radium Bromatum, Stannum Metallicum LIQUID ORAL 20140102 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALUMINUM OXIDE; ARSENIC; MERCURIC CHLORIDE; NICKEL; LEAD; RADIUM BROMIDE; TIN 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0046_3d20131a-91dd-423b-ab5b-59e97b7a0285 50845-0046 HUMAN OTC DRUG Snore Defense Antimonium tartaricum, Carbo vegetabilis, Lung suis, Mercurius corrosivus, Quebracho, Sticta pulmonaria, Teucrium marum, SPRAY ORAL 20101015 UNAPPROVED HOMEOPATHIC Liddell Laboratories ANTIMONY POTASSIUM TARTRATE; ACTIVATED CHARCOAL; SUS SCROFA LUNG; MERCURIC CHLORIDE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; TEUCRIUM MARUM 200; 12; 6; 200; 3; 200; 3 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0047_f088f519-95a3-4324-9044-520134c2556a 50845-0047 HUMAN OTC DRUG Anxiety plus Tension Agnus castus, Avena sativa, Cinchona officinalis, Humulus lupulus, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Valeriana officinalis SPRAY ORAL 20100811 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CHASTE TREE; AVENA SATIVA FLOWERING TOP; CINCHONA OFFICINALIS BARK; HOPS; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA TOP; VALERIAN 6; 1; 6; 2; 200; 200; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0048_ad483957-f7cc-4e9c-91a0-b34d202e9a4a 50845-0048 HUMAN OTC DRUG Attention Plus Arnica montana, Brain suis, Carduus marianus, Cinchona officinalis, Ginkgo biloba, Lecithin, Millefolium, Phosphoricum acidum, SPRAY ORAL 20101015 UNAPPROVED HOMEOPATHIC Liddell Laboratories ARNICA MONTANA; PORK BRAIN; SILYBUM MARIANUM SEED; CINCHONA OFFICINALIS BARK; GINKGO; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID; LECITHIN, SOYBEAN 3; 6; 3; 6; 6; 3; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL E 20171231 50845-0050_1b413b5b-bd46-486f-af55-4bd3c989bb4e 50845-0050 HUMAN OTC DRUG Loneliness and Sadness Ambra grisea, Argentum nitricum, Aurum metallicum, Avena sativa, Ignatia amara, Melissa officinalis, Sepia SPRAY ORAL 20100811 UNAPPROVED HOMEOPATHIC Liddell Laboratories AMBERGRIS; SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; MELISSA OFFICINALIS; SEPIA OFFICINALIS JUICE 6; 30; 30; 3; 4; 3; 6 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0053_25676761-9299-4d1b-ab86-9415c47a4327 50845-0053 HUMAN OTC DRUG Overwhelmed Antimonium Crudum, Arsenicum Album, Baryta Carbonica, Calcarea Phosphorica, Calcarea Silicata, Cicuta Virosa, Conium Maculatum SPRAY ORAL 20100811 UNAPPROVED HOMEOPATHIC Liddell Laboratories ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SILICATE; CICUTA VIROSA ROOT; CONIUM MACULATUM FLOWERING TOP 30; 30; 12; 12; 12; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0056_df782d83-7cff-4352-9c48-536498a6bca6 50845-0056 HUMAN OTC DRUG Brain Power Arnica montana, Brain suis, Carduus marianus, Cinchona officinalis, Ginkgo biloba, HGH, Lecithin, Millefolium, SPRAY ORAL 20101209 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; PORK BRAIN; SILYBUM MARIANUM SEED; CINCHONA OFFICINALIS BARK; GINKGO; SOMATROPIN; LECITHIN, SOYBEAN; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID; SILICON DIOXIDE; ZINC SULFATE HEPTAHYDRATE; SACCHAROMYCES CEREVISIAE RNA 3; 6; 3; 6; 6; 30; 12; 3; 30; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 50845-0057_b4b46b77-8c43-45dc-a620-0e2b94b8a3f0 50845-0057 HUMAN OTC DRUG Wart Free Antimonium crudum, Baptisia tinctoria, Causticum, Nitricum acidum, Thuja occidentalis, SPRAY ORAL 20110331 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANTIMONY TRISULFIDE; BAPTISIA TINCTORIA ROOT; CAUSTICUM; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG 30; 3; 200; 200; 200 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0058_6196bf1b-1a51-4d6d-9769-cb93e6a41665 50845-0058 HUMAN OTC DRUG Tension Headache Aconitum napellus, Carduus marianus, Coffea cruda, Dioscorea villosa, Gelsemium sempervirens, Gnaphalium polycephalum, Iris versicolor, SPRAY ORAL 20140602 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; MILK THISTLE; ARABICA COFFEE BEAN; DIOSCOREA VILLOSA TUBER; GELSEMIUM SEMPERVIRENS ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; IRIS VERSICOLOR ROOT; PASSIFLORA INCARNATA FLOWERING TOP; STELLARIA MEDIA; VERBASCUM THAPSUS 200; 3; 200; 3; 3; 3; 3; 2; 3; 3 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0058_71d24a96-3945-417f-8e2f-b3a465084c03 50845-0058 HUMAN OTC DRUG Tension Headache Aconitum napellus, Carduus marianus, Coffea cruda, Dioscorea villosa, Gelsemium sempervirens, Gnaphalium polycephalum, Iris versicolor, Passiflora incarnata Stellaria media, Verbascum thapsus, SPRAY ORAL 20110112 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; SILYBUM MARIANUM SEED; ARABICA COFFEE BEAN; DIOSCOREA VILLOSA ROOT; GELSEMIUM SEMPERVIRENS ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; IRIS VERSICOLOR ROOT; STELLARIA MEDIA; VERBASCUM THAPSUS; PASSIFLORA INCARNATA TOP 200; 3; 200; 3; 3; 3; 3; 3; 3; 2 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0067_371f4da9-329d-4c9f-8be8-1e4b4b62233b 50845-0067 HUMAN OTC DRUG Calcium Plus Alfalfa, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Hydrofluoricum acidum, Shark cartilage, Symphytum officinale, SPRAY ORAL 20110124 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALFALFA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; HYDROFLUORIC ACID; SHARK; COMFREY ROOT 1; 200; 30; 30; 30; 10; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 50845-0068_eeeb6bdd-091c-4637-a13e-c7ec55bd6b08 50845-0068 HUMAN OTC DRUG Arthritis Acontium napellus, Apis mellifica, Arnica montana, Berberis vulgaris, Bryonia, Calcarea fluorica. Cimicifuga racemosa, Colchicum autumnale, SPRAY ORAL 20100722 UNAPPROVED HOMEOPATHIC Liddell Laboratories ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; BLACK COHOSH; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; ST. JOHN'S WORT; MERCURIC CHLORIDE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; SHARK 200; 200; 3; 30; 200; 12; 6; 200; 200; 200; 200; 3; 200; 30; 200; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL E 20171231 50845-0071_f363bc72-ba27-4757-adf7-89b0c4cfd00d 50845-0071 HUMAN OTC DRUG Sinus Congestion Headache Antimonium tartaricum, Arsenicum iodatum, Asafoetida, Baptisia tinctoria, Echinacea, Eupoatorium perfoliatum, Euphorbia pilulifera, Hepar sulphuris calcareum, Hydratis canadensis, Kali bichromicum, Kreosotum, Lachesis mutus, Mercurius iodatus ruber, Pyrogenium, Silicea, Teucrium marum SPRAY ORAL 20100623 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIIODIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA HIRTA FLOWERING TOP; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; WOOD CREOSOTE; LACHESIS MUTA VENOM; MERCURIC IODIDE; RANCID BEEF; SILICON DIOXIDE; TEUCRIUM MARUM 6; 200; 30; 3; 3; 3; 3; 30; 30; 30; 30; 200; 200; 200; 30; 3 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0074_a4edd424-9b41-41ee-a147-60fccdc39aa9 50845-0074 HUMAN OTC DRUG VITAL II Arnica Montana, Carduus Marianus, Damiana, Galium Aparine, Hamamelis Virginiana, Hepar Suis, Korean Ginseng, L-Arginine, Oleum Animale, Pituitaria Glandula Suis, Schisandra Chinensis, Taraxacum Officinale, Thuja Occidentalis SPRAY ORAL 20140716 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; MILK THISTLE; TURNERA DIFFUSA LEAFY TWIG; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; ASIAN GINSENG; ARGININE; CERVUS ELAPHUS HORN OIL; SUS SCROFA PITUITARY GLAND; SCHISANDRA CHINENSIS FRUIT; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 3; 6; 3; 6; 6; 30; 3; 3; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 50845-0077_a128d081-f790-41c9-b0b7-2e13e8ad9790 50845-0077 HUMAN OTC DRUG Vital HGH Immune Booster Apis mellifica, Borax, Carduus marianus, Echinacea, Galium aparine, Hepar suis, HGH, Mercurius corrosivus, SPRAY ORAL 20100812 UNAPPROVED HOMEOPATHIC Liddell Laboratories APIS MELLIFERA; SODIUM BORATE; SILYBUM MARIANUM SEED; ECHINACEA; GALIUM APARINE; PORK LIVER; SOMATROPIN; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SUS SCROFA PITUITARY GLAND; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA THYMUS 200; 30; 3; 3; 3; 6; 30; 200; 30; 30; 30; 200; 200; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL E 20171231 50845-0084_1a3eb7cb-f7d0-44bc-9209-8309c4cd615d 50845-0084 HUMAN OTC DRUG HGH-Pro HGH, Hepar suis, Pituitary suis, SPRAY ORAL 20100927 UNAPPROVED HOMEOPATHIC Liddell Laboratories SOMATROPIN; PORK LIVER; SUS SCROFA PITUITARY GLAND 30; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0085_6063b633-ea37-4964-8fb5-49a5a82a11fb 50845-0085 HUMAN OTC DRUG Zeta Clear Antimonium crudum, Arsenicum album, Mancinella, Nitricum acidum, Sulphur, Thuja occidentalis, SPRAY ORAL 20100927 UNAPPROVED HOMEOPATHIC Liddell Laboratories ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; NITRIC ACID; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG 200; 200; 30; 12; 200; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 50845-0086_c2b6f1fd-0701-47bb-aa17-ce5d0b46ac91 50845-0086 HUMAN OTC DRUG Adrenal and DHEA Aralia quinquefolia, Arnica montana, Avena sativa, Carduus marianus, DHEA, Glandula suprarenalis suis, L-arginine, Natrum muriaticum, Phosphoricum acidum, Thuja occidentalis, Vitamin E, SPRAY ORAL 20101220 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AMERICAN GINSENG; ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; SILYBUM MARIANUM SEED; PRASTERONE; SUS SCROFA ADRENAL GLAND; ARGININE; SODIUM CHLORIDE; PHOSPHORIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; ALPHA-TOCOPHEROL 3; 3; 3; 3; 6; 12; 6; 30; 200; 200; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL E 20171231 50845-0092_b78ea0f8-304f-4e77-827b-afcaadd94ba6 50845-0092 HUMAN OTC DRUG Menopause Agnus Castus, Angelica Sinensis Radix, Apis Mellifica, Aralia Quinquefolia, Arnica Montana, Cimicifuga Racemosa, Galium Aparine, Glycyrrhiza Glabra, Oophorinum Suis, Sepia, Thuja Occidentalis, Viscum Album LIQUID ORAL 20140506 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CHASTE TREE; ANGELICA SINENSIS ROOT; APIS MELLIFERA; AMERICAN GINSENG; ARNICA MONTANA; BLACK COHOSH; GALIUM APARINE; GLYCYRRHIZA GLABRA; SUS SCROFA OVARY; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 3; 3; 6; 3; 6; 3; 3; 3; 30; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0095_27bb1eba-d37e-454c-a92a-25b62ecc9e6b 50845-0095 HUMAN OTC DRUG Vital HGH Skin, Hair and Nails Amino acids, Apis mellifica, Biotin, Epidermis, Galium aparine, Hamamelis virginiana, Hepar suis, HGH, Natrum muriaticum, SPRAY ORAL 20100903 UNAPPROVED HOMEOPATHIC Liddell Labroatories AMINO ACIDS; APIS MELLIFERA; BIOTIN; SUS SCROFA SKIN; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; SOMATROPIN; SODIUM CHLORIDE; PANTOTHENIC ACID; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; RIBOFLAVIN; THUJA OCCIDENTALIS LEAFY TWIG 10; 200; 10; 9; 5; 3; 6; 30; 200; 6; 3; 30; 6; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 50845-0099_bf2ed169-9244-402e-a1c6-e385d7fe38e6 50845-0099 HUMAN OTC DRUG Vital Weight Loss HCG Antimonium crudum, Apis mellifica, Capsicum annuum, Fucus vesiculosus, Galium aparine, Gambogia, Hamamelis virginiana, SPRAY ORAL 20101026 UNAPPROVED HOMEOPATHIC Liddell Laboratories ANTIMONY TRISULFIDE; APIS MELLIFERA; CAPSICUM; FUCUS VESICULOSUS; GALIUM APARINE; GAMBOGE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HUMAN CHORIONIC GONADOTROPIN; PORK LIVER; HISTAMINE DIHYDROCHLORIDE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; PETROSELINUM CRISPUM; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA THYROID; GINGER 8; 6; 6; 1; 3; 3; 3; 60; 12; 200; 30; 12; 3; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 50845-0100_f8f3b340-5fc5-44f8-87ac-ef8a78d94f6e 50845-0100 HUMAN OTC DRUG Morning Sickness Symphoricarpus racemosus, SPRAY ORAL 20110524 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. SYMPHORICARPOS ALBUS FRUIT 30 [hp_C]/mL N 20181231 50845-0101_4497611f-0fe2-42a4-9357-2ed375123dc3 50845-0101 HUMAN OTC DRUG Candida Yeast Baptisia tinctoria, Borax, Candida albicans, Candida parapsilosis, Echinacea, Kreosotum, Mercurius cyanatus, Mercurius sulphuratus ruber, Nitricum acidum, SPRAY ORAL 20101018 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BAPTISIA TINCTORIA ROOT; SODIUM BORATE; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA, UNSPECIFIED; MERCURIC SULFIDE; MERCURIC CYANIDE; NITRIC ACID; RANCID BEEF; SULFURIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTE 3; 30; 12; 12; 3; 30; 30; 30; 200; 30; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 50845-0102_99fe6d92-bc89-4a83-91d5-e22642b9dc96 50845-0102 HUMAN OTC DRUG Stomach Distress Arsenicum Album, Calcarea Sulphurica, Carbo Animalis, Carbo Vegetabilis, Cinchona Officinalis, Hydrastis Canadensis, Nux Vomica, Ornithogalum Umbellatum, Pyrogenium, Silicea, SPRAY ORAL 20110726 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; CARBO ANIMALIS; ACTIVATED CHARCOAL; CINCHONA OFFICINALIS BARK; GOLDENSEAL; STRYCHNOS NUX-VOMICA SEED; ORNITHOGALUM UMBELLATUM; RANCID BEEF; SILICON DIOXIDE 200; 200; 12; 12; 200; 12; 200; 12; 200; 12 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0103_2044920b-ad3c-4d7b-9df4-63832255dd50 50845-0103 HUMAN OTC DRUG Incontinence Belladonna, Cantharis, Causticum, Cina, Equisetum hyemale, Ignatia amara, Physalis alkekengi, Sepia, Uranium nitricum, Verbascum thapsus, SPRAY ORAL 20140512 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ATROPA BELLADONNA; LYTTA VESICATORIA; CAUSTICUM; ARTEMISIA CINA PRE-FLOWERING TOP; EQUISETUM HYEMALE; STRYCHNOS IGNATII SEED; PHYSALIS ALKEKENGI FRUIT; SEPIA OFFICINALIS JUICE; URANYL NITRATE HEXAHYDRATE; VERBASCUM THAPSUS 200; 200; 200; 6; 3; 200; 3; 200; 12; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0104_fb246331-5809-40e8-8d58-5e5f51be0c73 50845-0104 HUMAN OTC DRUG EMF Arnica montana, Arsenicum album, Baptisia tinctoria, Cinchona officinalis, Galium aparine, Hepar suis, Korean ginseng, Mercurius corrosivus, Phosphoricum acidum, Radium bromatum, Sulphur iodatum, Thuja occidentalis, X-ray SPRAY ORAL 20110624 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; GALIUM APARINE; PORK LIVER; ASIAN GINSENG; MERCURIC CHLORIDE; PHOSPHORIC ACID; RADIUM BROMIDE; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; ALCOHOL, X-RAY EXPOSED (1000 RAD) 3; 200; 3; 6; 3; 6; 1; 200; 3; 200; 200; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0105_001df7d5-d768-4d77-bf12-85c729e612fd 50845-0105 HUMAN OTC DRUG LIVER DETOX Bryonia (Alba), Carduus Marianus, Chelidonium Majus, Hepar Suis, Taraxacum Officinale SPRAY ORAL 20150112 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BRYONIA ALBA ROOT; MILK THISTLE; CHELIDONIUM MAJUS; PORK LIVER; TARAXACUM OFFICINALE 200; 1; 200; 6; 1 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0106_436b774a-7d03-4dc7-9a32-6afb54b6a4dd 50845-0106 HUMAN OTC DRUG Diuretic Apis Mellifica, Berberis Vulgaris, Helleborus Niger, Juniperus Communis, Prunus Spinosa, Strophanthus Hispidus, Taraxacum Officinale, Uva-Ursi SPRAY ORAL 20121126 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; HELLEBORUS NIGER ROOT; JUNIPERUS COMMUNIS WHOLE; PRUNUS SPINOSA FLOWER BUD; STROPHANTHUS HISPIDUS SEED; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF 3; 3; 3; 1; 3; 6; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0107_6f48b438-bbab-4b80-84d1-c17634405043 50845-0107 HUMAN OTC DRUG Cold and Flu Anas Barbariae, Hepatis Et Cordis Extractum, Antimonium Tartaricum, Apis Mellifica, Baptisia Tinctoria, Bryonia (Alba), Lung Suis, Mercurius Corrosivus, Serum Anguillae, Sticta Pulmonaria SPRAY ORAL 20150317 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; SUS SCROFA LUNG; MERCURIC CHLORIDE; ANGUILLA ROSTRATA BLOOD SERUM; LOBARIA PULMONARIA 200; 200; 200; 3; 200; 6; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0108_48d9760e-1ef9-4348-ac90-815d14c83767 50845-0108 HUMAN OTC DRUG Insomnia Aquilegia vulgaris, Avena sativa, Chamomilla, Coffea cruda, Cypripedium pubescens, Humulus lupulus, Hypericum perforatum, Kali phosphoricum, Melatonin, Melissa officinalis, Natrum muriaticum, Passiflora incarnata, Valeriana officinalis SPRAY ORAL 20121204 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AQUILEGIA VULGARIS; AVENA SATIVA FLOWERING TOP; MATRICARIA CHAMOMILLA WHOLE; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HOPS; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; MELATONIN; MELISSA OFFICINALIS; SODIUM CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 2; 2; 2; 6; 3; 3; 3; 12; 6; 3; 30; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0109_32d73ef5-5036-4a02-ab95-ff1c2fd27d23 50845-0109 HUMAN OTC DRUG PMS Apis Mellifica, Chamomilla, Cimicifuga Racemosa, Cuprum Metallicum, Ignatia Amara, Kali Iodatum, Magnesia Phosphorica, Oophorinum (Suis), Platinum Metallicum, Sepia, Thuja Occidentalis SPRAY ORAL 20110718 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; MATRICARIA RECUTITA; BLACK COHOSH; COPPER; STRYCHNOS IGNATII SEED; POTASSIUM IODIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SUS SCROFA OVARY; PLATINUM; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 200; 12; 6; 12; 6; 200; 9; 30; 12; 9; 200 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 50845-0110_438b141d-a568-4006-8afa-24e9443d0412 50845-0110 HUMAN OTC DRUG Bladder UTI Apis Mellifica, Arsenicum Iodatum, Berberis Vulgaris, Cantharis, Coccus Cacti, Echinacea, Mercurius Corrosivus LIQUID ORAL 20121127 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIIODIDE; BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; PROTORTONIA CACTI; ECHINACEA ANGUSTIFOLIA; MERCURIC CHLORIDE; RUBIA TINCTORUM ROOT; THUJA OCCIDENTALIS LEAF; GINGER 200; 200; 6; 200; 3; 1; 200; 1; 200; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0112_d0f132dc-ee23-4525-a5bc-d54cb60df11f 50845-0112 HUMAN OTC DRUG Asthma Arsenicum Iodatum, Blatta Orientalis, Bryonia, Carbo Vegetabilis, Eupatorium Perfoliatum, Histaminum Hydrochloricum, Ipecacuanha, Lung Suis, Mercurius Corrosivus, Natrum Sulphuricum, Quebracho, Sambucus Nigra, Sticta Pulmonaria, Urtica Urens SPRAY ORAL 20101103 UNAPPROVED HOMEOPATHIC Liddell Laboratories ARSENIC TRIIODIDE; BLATTA ORIENTALIS; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; EUPATORIUM PERFOLIATUM FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; IPECAC; SUS SCROFA LUNG; MERCURIC CHLORIDE; SODIUM SULFATE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; EUROPEAN ELDERBERRY; LOBARIA PULMONARIA; URTICA URENS 200; 30; 6; 12; 6; 200; 4; 6; 200; 30; 3; 3; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0113_ab1db44b-9486-46f6-bb00-0fb3c26a946b 50845-0113 HUMAN OTC DRUG Testosterone Avena sativa, Carduus marianus, Damiana, Galium aparine, Hamamelis virginiana, Hepar bovinum, Korean ginseng, Nuphar luteum, Orchitinum bovinum, SPRAY ORAL 20101227 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AVENA SATIVA FLOWERING TOP; SILYBUM MARIANUM SEED; TURNERA DIFFUSA LEAFY TWIG; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ASIAN GINSENG; POPULUS TREMULOIDES BARK; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG; BEEF LIVER; NUPHAR LUTEUM ROOT; BOS TAURUS TESTICLE 1; 1; 1; 3; 1; 1; 1; 30; 200; 6; 2; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0114_60d13e63-4775-430d-9bdb-7b496635b426 50845-0114 HUMAN OTC DRUG Immune Booster Apis mellifica, Borax, Carduus marianus, Echanacea, Galium aparine, Hepar suis, HGH, Mercurius corrosivus, Mercurius sulphuratus ruber, Nitricum acidum, Pituitary suis, Sulphur iodatum, Thua occidenta SPRAY ORAL 20101215 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; SODIUM BORATE; SILYBUM MARIANUM SEED; ECHINACEA; GALIUM APARINE; PORK LIVER; SOMATROPIN; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SUS SCROFA PITUITARY GLAND; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA THYMUS 200; 30; 3; 3; 3; 6; 30; 200; 30; 30; 30; 200; 200; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL E 20171231 50845-0119_d389e186-5711-470d-8b51-79a9438b1a8a 50845-0119 HUMAN OTC DRUG Earache Aconitum napellus, Anthracinum, Arnica montana, Baptisia tinctoria, Capsicum annuum, Chamomilla, Chenopodium anthelminticum, Euphorbium officinarum, Lachesis mutus, Magnesia phosphorica, SPRAY ORAL 20110125 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; CAPSICUM; CHAMOMILE; CHENOPODIUM AMBROSIOIDES; EUPHORBIA RESINIFERA RESIN; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIC CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; VERBASCUM THAPSUS 200; 200; 200; 3; 6; 3; 4; 4; 200; 8; 200; 3; 30; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0120_59528a53-928c-444c-a145-f8e509458b81 50845-0120 HUMAN OTC DRUG Canker and Cold Sore Apis mellifica, Arsenicum album, Baptisia tinctoria, Borax Capsicum annuum, Dulcamara, Echinacea, Mercurius corrosivus, Nitricum acidum, Pyrogenium, Rhus toxicodendron, Sulphur iodatum, Thuja occ iden SPRAY ORAL 20110112 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; SODIUM BORATE; CAPSICUM; SOLANUM DULCAMARA TOP; ECHINACEA; MERCURIC CHLORIDE; NITRIC ACID; RANCID BEEF; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF 3; 200; 3; 200; 6; 30; 3; 200; 200; 200; 200; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_M]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 50845-0121_6e377885-f4a0-4911-9b7e-0f1031f8da67 50845-0121 HUMAN OTC DRUG Delivery Support Caulphyllum Thalictroides, Pulsatilla, Sepia SPRAY ORAL 20110113 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc CAULOPHYLLUM THALICTROIDES ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 30; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0122_7cf9d96e-11ec-4bcf-8603-b11a88df1531 50845-0122 HUMAN OTC DRUG Teething Aconitum napellus, Belladonna, Borax, Calcarea phosphorica, Chamomilla, Kali phosphoricum, Magnesia phosphorica, Nitricum acidum, Staphysagria, LIQUID ORAL 20110125 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; SODIUM BORATE; TRIBASIC CALCIUM PHOSPHATE; CHAMOMILE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; NITRIC ACID; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 8; 3; 6; 8; 30; 9 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0123_33575489-1a92-415e-ba61-be28f901e617 50845-0123 HUMAN OTC DRUG ProBLEN Libido Damiana, Galium aparine, Glandula suprarenalis bovinum, Hepar bovinum, Korean ginseng, Nuphar luteum, Orchitinum bovinum, Phosphoricum acidum, Pituitary bovinum, Populus tremuloides, Testosterone, SPRAY ORAL 20110126 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. TURNERA DIFFUSA LEAFY TWIG; GALIUM APARINE; BOS TAURUS ADRENAL GLAND; BEEF LIVER; ASIAN GINSENG; PHOSPHORIC ACID; POPULUS TREMULOIDES LEAF; TESTOSTERONE; NUPHAR LUTEUM ROOT; BOS TAURUS TESTICLE; BOS TAURUS PITUITARY GLAND 3; 3; 12; 6; 1; 200; 3; 30; 2; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0124_3186b6e5-191d-4547-be7f-b15c1139737f 50845-0124 HUMAN OTC DRUG Appetite Increase Alfalfa, Avena sativa, Oleum morrhuae SPRAY ORAL 20110328 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; COD LIVER OIL 1; 1; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0125_a124387e-6060-4f91-b8f3-20e5882a68c5 50845-0125 HUMAN OTC DRUG Hemorrhoid Relief Aesculus hippocastanum, Arnica Montana, Calcarea fluorica, Carduus marianus, Collinsonia canadensis, Hamamelis virginiana, Muriaticum acidum, Ratanhia, SPRAY ORAL 20110328 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CALCIUM FLUORIDE; SILYBUM MARIANUM SEED; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT 1; 3; 9; 1; 3; 1; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0126_091d0441-511d-49f9-865b-45abda5cbbbb 50845-0126 HUMAN OTC DRUG Herpeset Apis mellifica, Arsenicum album, Baptisia tinctoria, Capsicum annuum, Dulcamara, Echinacea, Nitricum acidum, Pyrogenium, Rhus toxicodendron, SPRAY ORAL 20110707 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CAPSICUM; SOLANUM DULCAMARA FLOWER; ECHINACEA; NITRIC ACID; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 3; 200; 3; 6; 30; 3; 200; 200; 200 [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 50845-0127_adf30e28-8f5d-4530-8155-924f9b71fbaa 50845-0127 HUMAN OTC DRUG CHEMICALS Arsnicum Album, Carduus Marianus, Hepar Suis, Lung Suis, Pancreas Suis, Radium Bromatum, Serum Anguillae, Terebinthina SPRAY ORAL 20130731 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARSENIC TRIOXIDE; SILYBUM MARIANUM SEED; PORK LIVER; SUS SCROFA LUNG; SUS SCROFA PANCREAS; RADIUM BROMIDE; ANGUILLA ROSTRATA BLOOD SERUM; TURPENTINE OIL; ALCOHOL, X-RAY EXPOSED (1000 RAD); GINGER 200; 3; 6; 6; 6; 200; 30; 6; 200; 6 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0129_5dadda19-df1d-4bd1-bf00-b6cfdb43f885 50845-0129 HUMAN OTC DRUG Alcohol Safeguard Carboneum sulphuratum, Carduus marianus, Ceanothus americanus, Hepar suis, Pancreas suis, Quercus glandium spitirus, Ranunculus bulbosus, SPRAY ORAL 20110412 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CARBON DISULFIDE; SILYBUM MARIANUM SEED; CEANOTHUS AMERICANUS LEAF; PORK LIVER; SUS SCROFA PANCREAS; QUERCUS ROBUR NUT; RANUNCULUS BULBOSUS 6; 1; 30; 6; 6; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0130_acecfee9-b0aa-4d83-84ba-a60aa6d9ad88 50845-0130 HUMAN OTC DRUG Tinnitus Control Arnica montana, Chininum sulphuricum, Ferrum metallicum, Kali phosphoricum, Natrum sulphuricum, Pulsatilla, Silicea, Thiosinaminum, SPRAY ORAL 20110426 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; QUININE SULFATE; IRON; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; PULSATILLA VULGARIS; SILICON DIOXIDE; ALLYLTHIOUREA 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0131_acf9555d-7ec3-4476-bddb-53dec43708e1 50845-0131 HUMAN OTC DRUG Eazol Aconitum napellus, Arsenicum album, Coffea cruda, Euphorbium officinarum, Gnaphalium polycephalum, Hypericum perforatum, Magnesia phosphorica, Passiflora incarnata, Ranunculus bulbosus, SPRAY ORAL 20110415 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ARABICA COFFEE BEAN; EUPHORBIA RESINIFERA RESIN; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PASSIFLORA INCARNATA TOP; RANUNCULUS BULBOSUS 200; 200; 200; 4; 3; 200; 12; 1; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0132_7f4ece5c-ea1f-4057-ae27-af1f05a50cb0 50845-0132 HUMAN OTC DRUG ProBlen DNA RNA Rejuvenation Arnica montana, Avena sativa, Damiana, DNA, Korean ginseng, Oleum animale, Pituitary bovinum, RNA, Thuja occidentalis, Tribulus terrestris, SPRAY ORAL 20110412 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; TURNERA DIFFUSA LEAFY TWIG; ASIAN GINSENG; THUJA OCCIDENTALIS LEAFY TWIG; HERRING SPERM DNA; SACCHAROMYCES CEREVISIAE RNA; TRIBULUS TERRESTRIS ROOT; CERVUS ELAPHUS HORN OIL; BOS TAURUS PITUITARY GLAND 6; 3; 3; 3; 6; 9; 9; 3; 6; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 50845-0133_1f299780-b7a8-4f3e-9ab8-c49ee7b59cec 50845-0133 HUMAN OTC DRUG GH Hepar suis, HGH, Pituitary suis, SPRAY ORAL 20110620 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0134_3dd4f4a5-fc1d-4d8b-a956-4643bd106296 50845-0134 HUMAN OTC DRUG Miracet Abies nigra, Aconitum napellus, Arsenicum iodatum, Avena sativa, Ignatia amara, Lung suis, Nux vomica, Plantago major, Quebracho, Sticta pulmonaria, Tabacum, SPRAY ORAL 20110624 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. PICEA MARIANA RESIN; ACONITUM NAPELLUS; ARSENIC TRIIODIDE; AVENA SATIVA FLOWERING TOP; STRYCHNOS IGNATII SEED; SUS SCROFA LUNG; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; QUEBRACHO BARK; LOBARIA PULMONARIA; TOBACCO LEAF 10; 200; 200; 1; 200; 6; 10; 3; 3; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 50845-0135_d503dfa8-05b7-48f4-9406-475151baa869 50845-0135 HUMAN OTC DRUG Insect Bites Anthracinum, Apis Mellifica, Arnica Montana, Calendula Officinalis, Conium Maculatum, Echinacea (Angustifolia), Euphorbia Pilulifera, Grindelia, Histaminum Hydrochloricum, Hypericum perforatum, Lachesis Mutus, Latrodectus Mactans, Ledum Palustre, Pyrogenium, Tarentula Cubensis LIQUID ORAL 20140707 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; APIS MELLIFERA; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; EUPHORBIA HIRTA FLOWERING TOP; GRINDELIA HIRSUTULA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; RANCID BEEF; CITHARACANTHUS SPINICRUS 200; 3; 200; 3; 200; 3; 4; 6; 12; 6; 200; 30; 6; 30; 10 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0136_9e94ab1b-cc14-4659-8049-519446a2f50d 50845-0136 HUMAN OTC DRUG Herpes Simplex Apis mellifica, Arsenicum album, Baptisia tinctoria, Capsicum annuum, Dulcamara, Echinacea (Angustifolia), Nitricum acidum, Pyrogenium, Rhus tox SPRAY ORAL 20110609 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CAPSICUM; SOLANUM DULCAMARA FLOWER; ECHINACEA ANGUSTIFOLIA; NITRIC ACID; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 3; 200; 3; 6; 30; 3; 200; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0137_d6261b16-d1c1-4dca-90f4-65d4abbbbe8e 50845-0137 HUMAN OTC DRUG Anti Inflammatory Aconitum napellus, Apis mellifica, Arnica montana, Cartilago suis, Hydrastis canadensis, Hypericum perforatum, Rhus tox, Thuja occidentalis, SPRAY ORAL 20110617 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; SUS SCROFA CARTILAGE; GOLDENSEAL; HYPERICUM PERFORATUM; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG 200; 200; 200; 6; 6; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20191231 50845-0138_008d2cb1-f8ff-4f95-9e75-d8ddedf2ecee 50845-0138 HUMAN OTC DRUG ProBLEN Estrogen and Progesterone Agnus castus, Angelica sinesis, radix, Apis mellifica, Arnica montana, Cimicifuga racemosa, Estradiol, Estriol, Folliculinum, Galium aparine, SPRAY ORAL 20101221 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CHASTE TREE; ANGELICA SINENSIS ROOT; APIS MELLIFERA; ARNICA MONTANA; BLACK COHOSH; ESTRADIOL; ESTRIOL; ESTRONE; GALIUM APARINE; GLYCYRRHIZA GLABRA; ASIAN GINSENG; PROGESTERONE; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP; BOS TAURUS OVARY 3; 3; 6; 6; 3; 9; 9; 9; 3; 3; 3; 6; 30; 6; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 50845-0150_31432fdd-5f76-4cdc-a1a1-34d6730a9f13 50845-0150 HUMAN OTC DRUG Vital Weight Loss XL Antimonium Crudum, Apis Mellifica, Capsicum Annuum, Fucus Vesiculosus, Galium Aparine, Gambogia, Hamamelis Virginiana, Hepar Suis, Histaminum Hydrochloricum, Nux Vomica, Pancreas Suis, Petroselinum Sativum, Thuja Occidentalis, Thyroidinum Suis, Zingiber Officinale LIQUID ORAL 20131025 20210408 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; CAPSICUM; FUCUS VESICULOSUS; GALIUM APARINE; GAMBOGE; HAMAMELIS VIRGINIANA BARK; PORK LIVER; HISTAMINE DIHYDROCHLORIDE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; PETROSELINUM CRISPUM; THUJA OCCIDENTALIS LEAF; SUS SCROFA THYROID; GINGER 8; 6; 6; 1; 3; 3; 3; 12; 200; 30; 12; 3; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0151_5fb1bfc1-5849-43e9-80d7-fae7f0878d8e 50845-0151 HUMAN OTC DRUG Motion Sickness Cocculus indicus, Hepar suis, Nux vomica, Petroleum, Phosphoricum acidum, Tabacum, SPRAY ORAL 20110617 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANAMIRTA COCCULUS SEED; PORK LIVER; STRYCHNOS NUX-VOMICA SEED; LIQUID PETROLEUM; PHOSPHORIC ACID; TOBACCO LEAF 200; 6; 6; 6; 200; 6 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0152_56cad3cd-2d39-472a-b48d-1f5b9bbfe1d6 50845-0152 HUMAN OTC DRUG Attention Plus Arnica montana, Brain suis, Carduus marianus, Cinchona officinalis, Ginkgo biloba, Lecithin, Millefolium, Phosphoricum acidum, SPRAY ORAL 20110620 20201222 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; PORK BRAIN; SILYBUM MARIANUM SEED; CINCHONA OFFICINALIS BARK; GINKGO; LECITHIN, SOYBEAN; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID 3; 4; 3; 6; 6; 12; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 50845-0155_4dc29345-cfc0-41c4-98ce-fe458ab3c77e 50845-0155 HUMAN OTC DRUG Caffeine Free Avena sativa, Chamomilla, Coffea cruda, Gratiola officinalis, Hyoscyamus niger, Ignatia amara, Nux vomica, Paullinia sorbilis, Thuja occidentalis, SPRAY ORAL 20110916 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; GRATIOLA OFFICINALIS; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PAULLINIA CUPANA SEED; THUJA OCCIDENTALIS LEAFY TWIG 1; 3; 3; 6; 200; 200; 200; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0162_7ebb4ed8-bd44-4c67-b44b-57388a99cc6c 50845-0162 HUMAN OTC DRUG POSTPARTUM BLUES Aconitum Napellus, Ambra Grisea, Hypericum Perforatum, Ignatia Amara, Nux Vomica, Spigelia Anthelmia SPRAY ORAL 20150113 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; AMBERGRIS; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SPIGELIA ANTHELMIA 30; 30; 3; 30; 200; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0163_8b7f8835-cb0b-455e-b573-0def5c5fe3c2 50845-0163 HUMAN OTC DRUG Party Detox Arsenicum album, Avena sativa, Bryonia, Carbo animalis, Carduus marianus, Chelidonium majus, Hepar suis, Kali iodatum, Lapis albus, Nux vomica, Radium bromatum, Taraxacum officinale, Thuja occidentalis, SPRAY ORAL 20111003 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BRYONIA ALBA ROOT; CARBO ANIMALIS; MILK THISTLE; CHELIDONIUM MAJUS; PORK LIVER; POTASSIUM IODIDE; CALCIUM HEXAFLUOROSILICATE; STRYCHNOS NUX-VOMICA SEED; RADIUM BROMIDE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG 200; 1; 200; 200; 1; 200; 6; 200; 200; 30; 200; 1; 200 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 50845-0167_d5985361-8141-4b85-9b59-177397e718ca 50845-0167 HUMAN OTC DRUG DNA RNA Spectrum Alanine, Arginine, Asparagine, Aspartate, Cysteine, Glutamate, Glutamine, Glycine, Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Proline, Serine, Threonine, Tyrosine, Tryptophan, SPRAY ORAL 20110929 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALANINE; ARGININE; ASPARAGINE; CYSTEINE; MONOSODIUM GLUTAMATE ANHYDROUS; GLUTAMINE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TYROSINE; TRYPTOPHAN; VALINE; AVENA SATIVA FLOWERING TOP; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SILICON DIOXIDE; CHLORELLA VULGARIS; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; SOMATROPIN; ASIAN GINSENG; NUPHAR LUTEUM ROOT; TOXICODENDRON PUBESCENS LEAF; SACCHAROMYCES CEREVISIAE RNA; SELENIUM; ZINC; ASPARTIC ACID; SPIRULINA PLATENSIS 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 3; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 6; 3; 6; 24; 3; 3; 200; 6; 8; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0168_f8c02c86-4d06-4eae-9ba0-93b3a6c1a563 50845-0168 HUMAN OTC DRUG Air Pollution Detox Argentum nitricum, Arsenicum album, Carduus marianus, Hepar suis, Lung suis, Mercurius corrosivus, Plumbum metallicum, SPRAY ORAL 20121204 UNAPPROVED HOMEOPATHIC Liddell Laboratoriess, Inc. SILVER NITRATE; ARSENIC TRIOXIDE; SILYBUM MARIANUM SEED; PORK LIVER; SUS SCROFA LUNG; MERCURIC CHLORIDE; LEAD 200; 200; 1; 6; 6; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0169_4f9a3695-892c-43f8-a910-e37c93a86b9a 50845-0169 HUMAN OTC DRUG ProBLEN Estrogen and Progesterone Agnus castus, Angelica sinensis, radix, Apis mellifica, Arnica montana, Cimicifuga racemosa, Estradiol, Estriol, Folliculinum, Galium aparine, Glycyrrhiza glabra, Korean ginseng, SPRAY ORAL 20120131 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CHASTE TREE; ANGELICA SINENSIS ROOT; APIS MELLIFERA; ARNICA MONTANA; BLACK COHOSH; ESTRADIOL; ESTRIOL; ESTRONE; GALIUM APARINE; GLYCYRRHIZA GLABRA; ASIAN GINSENG; SUS SCROFA OVARY; PROGESTERONE; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 3; 3; 6; 6; 3; 9; 9; 9; 3; 3; 3; 30; 6; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0172_abf0a68e-8a8a-4435-83af-66d0b0c7db81 50845-0172 HUMAN OTC DRUG LiverActive Bryonia, Carduus marianus, Chelidonium majus, Hepar suis, Taraxacum officinale, SPRAY ORAL 20111229 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; PORK LIVER; TARAXACUM OFFICINALE 200; 1; 200; 6; 1 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 50845-0177_7eedbef8-643e-4ebb-ba43-b278d3575171 50845-0177 HUMAN OTC DRUG Bedwetting Belladonna, Cantharis, Causticum, Cina, Equisetum hyemale, Ingatia amara, Physalis alkekengi, Sepia, Uranium nitricum, Verbascum thapsus, LIQUID ORAL 20121115 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ATROPA BELLADONNA; LYTTA VESICATORIA; CAUSTICUM; ARTEMISIA CINA PRE-FLOWERING TOP; EQUISETUM HYEMALE; STRYCHNOS IGNATII SEED; PHYSALIS ALKEKENGI FRUIT; SEPIA OFFICINALIS JUICE; URANYL NITRATE HEXAHYDRATE; VERBASCUM THAPSUS 200; 200; 200; 6; 3; 200; 3; 200; 12; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0180_22a9fbf9-751d-4380-bf4d-2f098474ae8f 50845-0180 HUMAN OTC DRUG ProBLEN HGH Plus IGF-1 IGF-2 Arnica montana, Deer antler velvet, Hepar bovinum, HGH, IGF-1, Pitritary bovinum, Thuja occidentalis, SPRAY ORAL 20120214 20180408 UNAPPROVED HOMEOPATHIC Liddell Labratories, Inc. ARNICA MONTANA; CERVUS ELAPHUS VELVET; BEEF LIVER; SOMATROPIN; MECASERMIN; BOS TAURUS PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG 6; 8; 6; 24; 8; 5; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL E 20171231 50845-0181_f8687c1a-9494-45cb-b925-ccccd4f57c78 50845-0181 HUMAN OTC DRUG Laxative Aloe Socotrina, Alumina, Boldo, Bryonia, Graphites, Iris Versicolor, Lactobacillus Acidophilus, Lycopodium Clavatum, Nux Vomica, Pyrogenium, Rhamnus Purshiana SPRAY ORAL 20120417 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALOE; ALUMINUM OXIDE; PEUMUS BOLDUS LEAF; BRYONIA ALBA ROOT; GRAPHITE; IRIS VERSICOLOR ROOT; LACTOBACILLUS ACIDOPHILUS; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; RANCID BEEF; FRANGULA PURSHIANA BARK 3; 30; 1; 6; 12; 30; 14; 30; 30; 30; 3 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0183_8ac7dc0d-f755-4261-82f5-24b486fc4170 50845-0183 HUMAN OTC DRUG Injuries Anthracinum, Arnica montana, Bellis perennis, Calendula officinalis, Echinacea (Angustifolia), Hamamelis virginiana, Hypericum perforatum, Pyrogenium SPRAY ORAL 20120418 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RANCID BEEF 30; 3; 3; 3; 3; 3; 3; 200 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 50845-0184_5d363fa5-e933-4f5a-b750-194102641df4 50845-0184 HUMAN OTC DRUG Unique Pain Reduction Arthritis Aconitum Napellus, Apis Mellifica, Benzoicum Acidum, Cartilago Suis, Colchicum Autumnale, Eupatorium Perfoliatum, Guaiacum, Hypericum Perforatum, Ledum Palustre, Mercurius Corrosivus, Rhus Tox, Thuja Occidentalis LIQUID ORAL 20151210 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; BENZOIC ACID; SUS SCROFA CARTILAGE; COLCHICUM AUTUMNALE BULB; EUPATORIUM PERFOLIATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MERCURIC CHLORIDE; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG 200; 200; 6; 3; 200; 200; 3; 200; 6; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0185_9cbc6367-423d-4fbd-9dfc-c769b38a7b2d 50845-0185 HUMAN OTC DRUG VITAL HGH SKIN HAIR NAILS Amino Acids, Apis Mellifica, Biotin, Epidermis, Galium Aparine, Hamamelis Virginiana, Hepar Suis, HGH, Natrum Muriaticum, Pantothenic Acid, Phosphoricum Acidum, Pituitaria Glandula (Suis), Riboflavinum, Thuja Occidentalis SPRAY ORAL 20141002 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AMINO ACIDS; APIS MELLIFERA; BIOTIN; SUS SCROFA SKIN; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; SOMATROPIN; SODIUM CHLORIDE; PANTOTHENIC ACID; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; RIBOFLAVIN; THUJA OCCIDENTALIS LEAFY TWIG 10; 200; 10; 9; 5; 3; 6; 60; 200; 6; 3; 30; 6; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 50845-0186_0abb6e83-9a9b-4b9a-b123-084cc9e92578 50845-0186 HUMAN PRESCRIPTION DRUG Vaccines Arnica Montana, Mercurius Corrosivus, Sulphur Iodatum, Thuja Occidentalis, Urtica Urens, LIQUID ORAL 20131230 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; MERCURIC CHLORIDE; SULFUR IODIDE; THUJA OCCIDENTALIS LEAF; URTICA URENS 3; 200; 200; 200; 3 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0187_e435321f-990f-4201-afb7-21b7596faa74 50845-0187 HUMAN OTC DRUG Vital Brain Energy Arnica Montana, Brain Suis, Carduus Marianus, Cinchona Officinalis, Ginkgo Biloba, Lecithin, Millefolium, Phosphoricum Acidum LIQUID ORAL 20131025 20210620 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; PORK BRAIN; MILK THISTLE; CINCHONA OFFICINALIS BARK; GINKGO; EGG PHOSPHOLIPIDS; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID 3; 6; 3; 6; 6; 12; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 50845-0188_c85e8b96-51bc-423f-b446-efa80a4b3174 50845-0188 HUMAN OTC DRUG Colic Carbo vegetabilis, Cinchona officinalis, Colocynthis, Cuprum metallicum, Magnesia phosphorica, Ranunculus bulbosus, LIQUID ORAL 20121126 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACTIVATED CHARCOAL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RANUNCULUS BULBOSUS 9; 6; 30; 30; 12; 6 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0189_816d57b6-b427-48f0-ab2a-59eff31ab56b 50845-0189 HUMAN OTC DRUG Antacid Anacardium orientale, Argentum nitricum, Arsenicum album, Bismuthum metallicum, Condurango, Geranium maculatum, Nux vomica, Pyrogenium, Robinia pseudoacacia, Sulphuricum acidum, SPRAY ORAL 20121115 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ARSENIC TRIOXIDE; BISMUTH; MARSDENIA CONDURANGO BARK; GERANIUM MACULATUM ROOT; STRYCHNOS NUX-VOMICA SEED; RANCID BEEF; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID 6; 6; 200; 30; 200; 3; 6; 30; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0197_3b5ddaaf-ebc2-4bfe-aa50-aec14351964a 50845-0197 HUMAN OTC DRUG Vital Male Sexual Energy Arnica Montana, Caladium Seguinum, Carduus Marianus, Damiana, Galium Aparine, Glandula Suprarenalis Suis, Hepar Suis, Hypophysis Suis, Korean Ginseng, Lactuca Virosa, Nuphar Luteum, Orchitinum, Phosphoricum Acidum, Populus Tremuloides, Testosterone, Thuja Occidentalis, Thymus Suis, Thyroidinum Suis LIQUID ORAL 20140507 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; DIEFFENBACHIA SEGUINE; MILK THISTLE; TURNERA DIFFUSA LEAFY TWIG; GALIUM APARINE; SUS SCROFA ADRENAL GLAND; PORK LIVER; ASIAN GINSENG; LACTUCA VIROSA; NUPHAR LUTEUM ROOT; SUS SCROFA TESTICLE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; TESTOSTERONE; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA THYMUS; THYROID, PORCINE 3; 6; 3; 1; 3; 12; 6; 1; 3; 2; 6; 200; 12; 1; 1; 30; 200; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0199_a9d0292a-4162-43c3-890f-4b782a0baa58 50845-0199 HUMAN OTC DRUG Vital Age Defiance Human Growth Hormone, Hypophysis Suis, Hepar Suis SPRAY ORAL 20160908 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. SOMATROPIN; SUS SCROFA PITUITARY GLAND; PORK LIVER 30; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0200_37072589-b0fe-44f9-abcd-72ec47d221da 50845-0200 HUMAN OTC DRUG Candida Yeast Baptisia Tinctoria, Borax, Candida Albicans, Candida Parapsilosis, Echinacea (Angustifolia), Kreosotum, Mercurius Cyanatus, Mercurius Sulphuratus Ruber, Nitricum Acidum, Pyrogenium, Sulphuricum Acidum, Thuja Occidentalis SPRAY ORAL 20140221 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BAPTISIA TINCTORIA; SODIUM BORATE; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; ECHINACEA ANGUSTIFOLIA; WOOD CREOSOTE; MERCURIC CYANIDE; MERCURIC SULFIDE; NITRIC ACID; RANCID BEEF; SULFURIC ACID; THUJA OCCIDENTALIS LEAF 3; 30; 12; 8; 3; 30; 30; 30; 30; 200; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0202_1908b9f6-d2ca-4d92-9443-5f5cdccb9f0d 50845-0202 HUMAN OTC DRUG Pregnancy Balance Berber vulg, Carduus mar, Chelidonium maj, Podoph pelt, Serum anguillae, Symphoricarpus, Zingiber LIQUID ORAL 20140307 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; PODOPHYLLUM; ANGUILLA ROSTRATA BLOOD SERUM; SYMPHORICARPOS ALBUS FRUIT; GINGER 6; 3; 6; 6; 30; 200; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0203_d041bbf0-cbd8-4957-b5c5-f8eab314307d 50845-0203 HUMAN OTC DRUG Daily Balance Arsenicum album, Carbo animalis, Carduus marianus, Kali iodatum, Lapis albus, Radium bromatum, Thuja occidentalis LIQUID ORAL 20140307 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc ARSENIC TRIOXIDE; CARBO ANIMALIS; MILK THISTLE; POTASSIUM IODIDE; CALCIUM HEXAFLUOROSILICATE; RADIUM BROMIDE; THUJA OCCIDENTALIS LEAFY TWIG 200; 200; 1; 200; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0204_fd5dd5ad-0103-4fb0-a732-3a4588af0cc1 50845-0204 HUMAN OTC DRUG Diabetes Type II Aesculus hippocastanum, Arnica montana, Arsenicum album, Hamamelis virginiana, Helonias dioica, Hepar suis, Iris versicolor, Pancreas suis, SPRAY ORAL 20140429 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. HORSE CHESTNUT; ARNICA MONTANA; ARSENIC ACID; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CHAMAELIRIUM LUTEUM ROOT; PORK LIVER; IRIS VERSICOLOR ROOT; SUS SCROFA PANCREAS; PHOSPHORIC ACID; ROSMARINUS OFFICINALIS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 1; 3; 200; 3; 3; 6; 200; 6; 200; 3; 30; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 50845-0205_5b99c8a6-9d06-4bbc-bee2-b98c4615d81a 50845-0205 HUMAN OTC DRUG Allergy Allium Cepa, Apis Mellifica, Aralia Racemosa, Arundo Mauritanica, Baptisia Tinctoria, Echinacea (Angustifolia), Euphrasia Officinalis, Gelsemium Sempervirens, Histaminum Hydrochloricum, Lycopodium Clavatum, Rhus Tox, Sabadilla, Sanguinaria Canadensis, Urtica Urens SPRAY ORAL 20160511 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; ARUNDO PLINIANA ROOT; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SANGUINARIA CANADENSIS ROOT; URTICA URENS 6; 3; 6; 30; 3; 4; 6; 200; 12; 6; 200; 6; 200; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0206_6fb384bf-3c38-42da-90ea-625075136ff8 50845-0206 HUMAN OTC DRUG Ear Discomfort Aconitum napellus, Anthracinum, Arnica montana, Baptisia tintoria, Capsicum annuum, Chamomilla, Chenopodium anthelminticum, LIQUID ORAL 20140509 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; CAPSICUM; MATRICARIA RECUTITA; DYSPHANIA AMBROSIOIDES; EUPHORBIA RESINIFERA RESIN; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIC CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; VERBASCUM THAPSUS 200; 200; 200; 3; 6; 3; 6; 4; 200; 10; 200; 3; 30; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0207_419de917-a343-47b2-ae06-e967cd2837ce 50845-0207 HUMAN OTC DRUG Cough plus Bronchial Antimonium Tartaricum, Arsenicum Album, Arsenicum Iodatum, Arum Triphyllum, Baptisia Tinctoria, Bryonia (Alba), Drosera (Rotundifolia), Echinacea (Angustifolia), Eupatorium Perfoliatum, Kali Bromatum, Lung Suis, Mercurius Corrosivus, Sticta Pulmonaria, Sulphur Iodatum, Urtica Urens SPRAY ORAL 20140717 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; ARISAEMA TRIPHYLLUM ROOT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; POTASSIUM BROMIDE; SUS SCROFA LUNG; MERCURIC CHLORIDE; LOBARIA PULMONARIA; SULFUR IODIDE; URTICA URENS 200; 200; 200; 30; 3; 200; 30; 3; 200; 6; 6; 200; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0208_6212380c-fb29-417c-b19a-f361cd249b52 50845-0208 HUMAN OTC DRUG Arthritis Aconitum Napellus, Apis Mellifica, Arnica Montana, Berberis Vulgaris, Bryonia (Alba), Calcarea Fluorica, Cartilago Suis, Cimicifuga Racemosa, Colchicum Autumnale, Dulcamara, Hypericum Perforatum, Mercurius Corrosivus, Rhododendron Chrysanthemum, Rhus Tox, Solidago Virgaurea, Thuja Occidentalis SPRAY ORAL 20140527 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; SUS SCROFA CARTILAGE; BLACK COHOSH; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; HYPERICUM PERFORATUM; MERCURIC CHLORIDE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 200; 200; 3; 30; 200; 12; 8; 6; 200; 200; 200; 200; 3; 200; 30; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0209_d629450d-92a8-4755-941e-e23aaede583d 50845-0209 HUMAN OTC DRUG Sinus Congestion Headache Antimonium Tartaricum, Arsenicum Iodatum, Asafoetida, Baptisia Tinctoria, Echinacea (Angustifolia), Eupatorium Perfoliatum, Euphorbia Pilulifera, Hepar Sulphuris Calcareum, Hydrastis Canadensis, Kali Bichromicum, Kreosotum, Lachesis Mutus, Mercurius Iodatus Ruber, Pyrogenium, Silicea, Teucrium Marum SPRAY ORAL 20140613 20210218 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIIODIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA HIRTA FLOWERING TOP; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; WOOD CREOSOTE; LACHESIS MUTA VENOM; MERCURIC IODIDE; RANCID BEEF; SILICON DIOXIDE; TEUCRIUM MARUM 6; 200; 30; 3; 3; 3; 3; 30; 30; 30; 30; 200; 10; 200; 30; 3 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0211_6333f734-4b9a-4024-a790-d1985af2ff0a 50845-0211 HUMAN OTC DRUG Ear Discomfort Aconitum Napellus, Anthracinum, Arnica Montana, Baptisa Tinctoria, Capsicum Annuum, Chamomilla, Chenopodium Anthelminticum, LIQUID ORAL 20140708 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; CAPSICUM; MATRICARIA RECUTITA; DYSPHANIA AMBROSIOIDES; EUPHORBIA RESINIFERA RESIN; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIC CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; VERBASCUM THAPSUS 200; 200; 200; 3; 6; 3; 6; 4; 200; 8; 200; 3; 30; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0212_3d1dd231-a771-4c91-a276-c935f9c9ff86 50845-0212 HUMAN OTC DRUG Canker plus Cold Sore Relief Apis Mellifica, Arsenicum Album, Baptisia Tinctoria, Borax, Capsicum Annuum, Dulcamara, Echinacea (Angustifolia), Mercurius Corrosivus, Nitricum Acidum, Pyrogenium, Rhus Tox, Sulphur Iodatum, Thuja Occidentalis SPRAY ORAL 20140908 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; SODIUM BORATE; CAPSICUM; SOLANUM DULCAMARA TOP; ECHINACEA ANGUSTIFOLIA; MERCURIC CHLORIDE; NITRIC ACID; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG 3; 200; 3; 200; 6; 30; 3; 200; 200; 200; 200; 200; 200 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0213_0d773f60-b0be-4f97-86d2-308828d42e9b 50845-0213 HUMAN OTC DRUG Vital HGH Immune Booster Apis Mellifica, Borax, Carduus Marianus, Echinacea (Angustifolia), Galium Aparine, Hepar Suis, HGH, Mercurius Corrosivus, Mercurius Sulphuratus Ruber, Nitricum Acidum, Pituitaria Glandula (Suis), Sulphur Iodatum, Thuja Occidentalis, Thymus Suis SPRAY ORAL 20140918 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; SODIUM BORATE; MILK THISTLE; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; PORK LIVER; SOMATROPIN; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SUS SCROFA PITUITARY GLAND; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA THYMUS 200; 30; 3; 3; 3; 6; 30; 200; 30; 30; 30; 200; 200; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0214_a51939a2-8b96-4c4f-9006-6eb3e7758497 50845-0214 HUMAN OTC DRUG Skin Irritant and Healing Support Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (similax regelii) SPRAY TOPICAL 20150107 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0215_53ce91a0-ffa2-4f4d-bbe0-f0eb08842b9a 50845-0215 HUMAN OTC DRUG SHINGLES PAIN ULCERATION RELIEF Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20150105 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0216_65e356c3-27d1-4409-b561-ca0f05a500fb 50845-0216 HUMAN OTC DRUG First Aid Pain and Trauma Relief Calendula officinalis, Croton Tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20141230 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0217_8c4225bd-dfd4-40d4-80db-7276368ccdd2 50845-0217 HUMAN OTC DRUG Headache Pain and Sinus Pressure Relief Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20141231 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SARSAPARILLA 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0218_3d4dd18d-a8dd-421f-b01b-36413682fb54 50845-0218 HUMAN OTC DRUG Joint Pain and Stiffness Relief Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (similax regelii) SPRAY TOPICAL 20150106 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0219_c0db80a3-900e-47e2-aeb6-7ddec9a1449c 50845-0219 HUMAN OTC DRUG MUSCLE/TENDON PAIN AND STRESS RELIEF Calendula officinalis, Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla (smilax regelii) SPRAY TOPICAL 20141230 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0220_93952c84-0dee-48b3-9ed3-76fb9b7d47cd 50845-0220 HUMAN OTC DRUG CALCIUM PLUS Alfalfa, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Cartilago Suis, Hydrofluoricum Acidum, Symphytum Officinale LIQUID ORAL 20150220 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALFALFA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM FLUORIDE; SUS SCROFA CARTILAGE; HYDROFLUORIC ACID; COMFREY ROOT 1; 200; 30; 30; 10; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 50845-0221_04c7eae7-9830-4acb-836b-fc8b774c483e 50845-0221 HUMAN OTC DRUG Vital Skin Hair Nails L-Alanine, L-Arginine, L-Carnitine, Cysteinum, L-Glutamine, L-Histidine, L-Isoleucine, L-Leucine, L-Lysine, L-Methionine, L-Ornithine, L-Proline, L-Serine, L-Tryptophan, L-Tyrosine, L-Valine, Apis Mellifica, Biotin, Epidermis Suis, Galium Aparine, Hamamelis Virginiana, Hepar Suis, HGH, Hypophysis Suis, Natrum Muriaticum, Pantothenic Acid, Phosphoricum Acidum, Riboflavinum, Thuja Occidentalis SPRAY ORAL 20160427 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ALANINE; ARGININE; LEVOCARNITINE; CYSTEINE; GLUTAMINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; ORNITHINE; PROLINE; SERINE; TRYPTOPHAN; TYROSINE; VALINE; APIS MELLIFERA; BIOTIN; SUS SCROFA SKIN; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND; SODIUM CHLORIDE; PANTOTHENIC ACID; PHOSPHORIC ACID; RIBOFLAVIN; THUJA OCCIDENTALIS LEAFY TWIG 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 200; 10; 9; 5; 3; 6; 60; 30; 200; 6; 3; 6; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [kp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 50845-0222_b8ff8af8-b168-463e-aa83-d0a09cb4c1a3 50845-0222 HUMAN OTC DRUG Vital Immune Booster Apis Mellifica, Borax, Carduus Marianus, Echinacea (Angustifolia), Galium Aparine, Hepar Suis, HGH, Hypophysis Suis, Mercurius Corrosivus, Mercurius Sulphuratus Ruber, Nitricum Acidum, Sulphur Iodatum, Thuja Occidentalis, Thymus Suis SPRAY ORAL 20170421 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. APIS MELLIFERA; SODIUM BORATE; MILK THISTLE; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA THYMUS 200; 30; 3; 3; 3; 6; 30; 30; 200; 30; 30; 200; 200; 6 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0223_b3edbe2d-ff12-4e95-97fa-2dcf2dad7a3b 50845-0223 HUMAN OTC DRUG Muscle/Tendon Pain and Stress Relief Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20151204 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0224_b9248d88-7d8e-43de-aa88-d7b340f51999 50845-0224 HUMAN OTC DRUG Joint Pain and Stiffness Relief Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20151124 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0225_8e6ae36d-eab7-4db1-9c91-b405aa66a077 50845-0225 HUMAN OTC DRUG Shingles Pain Ulceration Relief Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20151125 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0226_7f21a851-84ad-406f-8adc-80b9ab1f44ed 50845-0226 HUMAN OTC DRUG Hemorrhoid Relief Aesculus Hippocastanum, Arnica Montana, Calcarea Fluorica, Carduus Marianus, Collinsonia Canadensis, Hamamelis Virginiana, Muriaticum Acidum, Ratanhia SPRAY ORAL 20151130 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CALCIUM FLUORIDE; MILK THISTLE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT 1; 3; 9; 1; 3; 3; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0227_16d26061-8d22-40d4-95f7-80af0a858535 50845-0227 HUMAN OTC DRUG Acne Anthracinum, Antimonium Crudum, Hydrocotyle Asiatica, Juglans Regia, Kali Bromatum, Ledum Palustre, Natrum Sulphuricum, Pyrogenium, Radium Bromatum, Sanguinaria Canadensis, Sulphur Iodatum, Thuja Occidentalis, Urtica Urens SPRAY ORAL 20160502 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ANTIMONY TRISULFIDE; CENTELLA ASIATICA; JUGLANS REGIA FLOWERING TOP; POTASSIUM BROMIDE; LEDUM PALUSTRE TWIG; SODIUM SULFATE; RANCID BEEF; RADIUM BROMIDE; SANGUINARIA CANADENSIS ROOT; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 200; 30; 30; 6; 30; 6; 200; 30; 200; 3; 200; 200; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0228_cec4b387-f5d5-479f-b79c-8ad8d39d1ca8 50845-0228 HUMAN OTC DRUG Shingles Pain Relief Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20160324 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0229_b4032fb7-93c0-4f8e-9305-101d8a012eff 50845-0229 HUMAN OTC DRUG Sinus Congestion Headache Antimonium Tartaricum, Arsenicum Iodatum, Asafoetida, Baptisia Tinctoria, Echinacea (Angustifolia), Eupatorium Perfoliatum, Euphorbia Pilulifera, Hepar Sulphuris Calcareum, Hydrastis Canadensis, Kali Bichromicum, Kreosotum, Lachesis Mutus, Mercurius Iodatus Ruber, Pyrogenium, Silicea, Teucrium Marum SPRAY ORAL 20160623 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIIODIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA HIRTA FLOWERING TOP; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; WOOD CREOSOTE; LACHESIS MUTA VENOM; MERCURIC IODIDE; RANCID BEEF; SILICON DIOXIDE; TEUCRIUM MARUM 6; 200; 30; 3; 3; 6; 3; 30; 30; 30; 30; 200; 10; 200; 30; 3 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 50845-0230_af56d8bf-8d58-4b40-8038-151116baf2e4 50845-0230 HUMAN OTC DRUG Attention Plus Arnica Montana, Carduus Marianus, Cerebrum Suis, Cinchona Officinalis, Ginkgo Biloba, Lecithin, Millefolium, Phosphoricum Acidum SPRAY ORAL 20160621 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; MILK THISTLE; SUS SCROFA CEREBRUM; CINCHONA OFFICINALIS BARK; GINKGO; LECITHIN, SOYBEAN; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID 3; 3; 6; 6; 6; 12; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 50845-0231_ea0c1b9c-6bc4-4b5f-ada7-bf9f8a4c8a93 50845-0231 HUMAN OTC DRUG Vital Brain Energy Arnica Montana, Carduus Marianus, Cerebrum Suis, Cinchona Officinalis, Ginkgo Biloba, Lecithin, Millefolium, Phosphoricum Acidum SPRAY ORAL 20160706 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ARNICA MONTANA; MILK THISTLE; SUS SCROFA CEREBRUM; CINCHONA OFFICINALIS BARK; GINKGO; LECITHIN, SOYBEAN; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID 3; 3; 6; 6; 6; 12; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 50845-0232_fa8a35c3-ddb0-4ad7-981e-33f27be04369 50845-0232 HUMAN OTC DRUG Vital Weight Loss XL Antimonium Crudum, Apis Mellifica, Capsicum Annuum, Fucus Vesiculosus, Galium Aparine, Garcinia Cambogia, Hamamelis Virginiana, Hepar Suis, Histaminum Hydrochloricum, Nux Vomica, Pancreas Suis, Petroselinum Sativum, Thuja Occidentalis, Thyroidinum Suis, Zingiber Officinale LIQUID ORAL 20160914 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; CAPSICUM; FUCUS VESICULOSUS; GALIUM APARINE; GARCINIA GUMMI-GUTTA FRUIT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; HISTAMINE DIHYDROCHLORIDE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; PETROSELINUM CRISPUM; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, PORCINE; GINGER 8; 6; 6; 1; 3; 3; 3; 12; 200; 30; 12; 3; 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20191231 50845-0233_c2e26c95-80e1-4cdc-bd23-d787ab7d45f9 50845-0233 HUMAN OTC DRUG Pain Aconitum Napellus, Arnica Montana, Arsenicum Album, Bellis Perennis, Cartilago Suis, Causticum, Chamomilla, Coffea Cruda, Euphorbium Officinarum, Gnaphalium Polycephalum, Hypericum Perforatum, Magnesia Phosphorica, Passiflora Incarnata, Pyrogenium, Ranunculus Bulbosus, Symphytum Officinale LIQUID ORAL 20170316 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BELLIS PERENNIS; SUS SCROFA CARTILAGE; CAUSTICUM; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; EUPHORBIA RESINIFERA RESIN; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PASSIFLORA INCARNATA TOP; RANCID BEEF; RANUNCULUS BULBOSUS; COMFREY ROOT 200; 3; 200; 3; 6; 200; 3; 200; 6; 3; 200; 12; 1; 200; 3; 6 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0234_fb0c897a-7448-4e92-814a-eaa93fb05855 50845-0234 HUMAN OTC DRUG Gluten Detox Barley (Grain), Carbo Vegetabilis, Cinchona Officinalis, Gluten, Glyphosate, Hydrastis Canadensis, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Oat (Grain), Pancreas Suis, Pulsatilla (Vulgaris), Rye (Grain), Wheat (Grain) LIQUID ORAL 20170523 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. BARLEY; ACTIVATED CHARCOAL; CINCHONA OFFICINALIS BARK; WHEAT GLUTEN; GLYPHOSATE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; OATMEAL; SUS SCROFA PANCREAS; ANEMONE PULSATILLA; RYE; WHEAT 12; 12; 6; 15; 12; 6; 200; 30; 30; 12; 6; 200; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 50845-0235_b58f0dcf-fc2f-4c4f-a28f-6829c23ed50f 50845-0235 HUMAN OTC DRUG Ear Discomfort Aconitum Napellus, Anthracinum, Arnica Montana, Baptisia Tinctoria, Capsicum Annuum, Chamomilla, Chenopodium Anthelminticum, Euphorbium Officinarum, Lachesis Mutus, Magnesia Mutus, Magnesia Phosphorica, Mercurius Corrosivus, Plantago Major, Pulsatilla (Vulgaris), Verbascum Thapsus LIQUID ORAL 20180118 UNAPPROVED HOMEOPATHIC Liddell Laboratories, Inc. ACONITUM NAPELLUS; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; CAPSICUM; MATRICARIA RECUTITA; DYSPHANIA AMBROSIOIDES; EUPHORBIA RESINIFERA RESIN; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIC CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; VERBASCUM THAPSUS 200; 200; 200; 3; 6; 3; 6; 6; 200; 10; 200; 3; 30; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 50859-100_5dc4d6ba-525d-412b-9bc9-8bd17595b3bb 50859-100 HUMAN OTC DRUG Ili Hand Sanitizer Instant Alcohol GEL TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part333E Strong Brands, Inc. ALCOHOL 63 mL/100mL E 20171231 50865-017_39e7461b-4f86-40dc-8465-4843629a5a40 50865-017 HUMAN OTC DRUG E2 SANITIZING HAND E2 SANITIZING HAND SOAP TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part333A KUTOL PRODUCTS COMPANY BENZALKONIUM CHLORIDE .003 mg/mL E 20171231 50865-025_f52dbdae-8fe2-4320-bd20-31ae3176c411 50865-025 HUMAN OTC DRUG Soft and Silky Antiseptic Antiseptic Lotion Soap SOLUTION TOPICAL 20131104 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. CHLOROXYLENOL 3.82 g/100mL E 20171231 50865-050_01de5d07-ab55-481e-a23b-c224f48d3bff 50865-050 HUMAN OTC DRUG Soft and Silky/Health Guard Antibacterial Hand Antibacterial Hand Soap LIQUID TOPICAL 20130920 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. TRICLOSAN 11.7 g/100mL E 20171231 50865-056_e5cfeb03-7d4a-41fa-9fda-b3ee64d78994 50865-056 HUMAN OTC DRUG Santi-Gel Instant Hand Sanitizer Santi-Gel Instant Hand Sanitizer SOLUTION TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. ALCOHOL 62.5 mL/100mL E 20171231 50865-060_dac6322d-29a0-4794-ae58-f715a99c8beb 50865-060 HUMAN OTC DRUG Golden Medicated Medicated Lotion Soap SOLUTION TOPICAL 20140311 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. CHLOROXYLENOL .3 g/100mL E 20171231 50865-076_8b85e5f9-57bb-4fb5-8d1f-42e79c31a55b 50865-076 HUMAN OTC DRUG 3 in 1 Antibacterial Hair and Body Wash 3 in 1 Antibacterial Hair and Body Wash SOLUTION TOPICAL 20131106 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. TRICLOSAN 11.7 g/100mL E 20171231 50865-207_4eccc0f5-55ec-3fab-e054-00144ff8d46c 50865-207 HUMAN OTC DRUG Foaming Instant Hand Sanitizer with Aloe and Vitamin E Foaming Instant Hand Sanitizer with Aloe and Vitamin E SOLUTION TOPICAL 20160531 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 50865-213_8e1424d5-1abf-47aa-9fbd-e04a4204e8b5 50865-213 HUMAN OTC DRUG Foaming Advanced Antibacterial Hand benzalkonium chloride SOAP TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333E Kutol Products Company BENZALKONIUM CHLORIDE .003 mg/mL E 20171231 50865-215_56f574f3-acd8-6df3-e054-00144ff88e88 50865-215 HUMAN OTC DRUG Antibacterial Hand Cleanser Benzalkonium chloride SOAP TOPICAL 20170817 OTC MONOGRAPH NOT FINAL part333E Kutol Products Company BENZALKONIUM CHLORIDE .013 mg/mL N 20181231 50865-217_5a5bd11f-5453-5512-e053-2a91aa0a1e73 50865-217 HUMAN OTC DRUG Health Guard Antibacterial Hand cleanser F217F Benzalkonium chloride SOAP TOPICAL 20170929 OTC MONOGRAPH NOT FINAL part333E Kutol Products Company BENZALKONIUM CHLORIDE .013 mg/mL N 20181231 50865-370_593ca91a-a2ab-3d1b-e053-2991aa0a0a30 50865-370 HUMAN OTC DRUG Gel Instant Hand Sanitizer alcohol SOAP TOPICAL 20170915 OTC MONOGRAPH NOT FINAL part333A Kutol Products ALCOHOL .07 mg/mL N 20181231 50865-640_42c06641-a461-41f4-b189-8024cff0fcac 50865-640 HUMAN OTC DRUG eZFoam Foaming Antibacterial Moisture Wash Foaming Antibacterial Handwash SOLUTION TOPICAL 20140106 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc TRICLOSAN 18.9 g/100mL E 20171231 50865-645_626ed157-f5b2-57e0-e053-2991aa0a500a 50865-645 HUMAN OTC DRUG FOAMING ANTIBACTERIAL WASH BENZALKONIUM CHLORIDE SOAP TOPICAL 20170913 OTC MONOGRAPH NOT FINAL part333A KUTOL PRODUCTS BENZALKONIUM CHLORIDE .013 mg/mL N 20191231 50865-650_07b50de3-3759-4b15-92a1-a9c39caaf838 50865-650 HUMAN OTC DRUG Antibacterial Hand Cleaner with Aloe and Vitamin E Antibacterial Hand Soap with Aloe and Vitamin E SOLUTION TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. TRICLOSAN .3 g/100mL E 20171231 50865-683_833cbbee-8401-49a6-a750-0a1011a33dd9 50865-683 HUMAN OTC DRUG Foaming Sanitizing Hand benzalkonium chloride SOAP TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333E Kutol Products Company BENZALKONIUM CHLORIDE .003 mg/mL E 20171231 50865-689_6b1dd498-17a9-4ea1-8f3d-b0f2a38144fe 50865-689 HUMAN OTC DRUG eZ Foam Foaming Antibacterial Hand Foaming Antibacterial Hand Soap with Aloe and Vitamin E SOLUTION TOPICAL 20130923 OTC MONOGRAPH NOT FINAL part333A Kutol Products Company, Inc. TRICLOSAN 18.9 g/100mL E 20171231 50865-710_30d96f6f-8caf-3867-e054-00144ff88e88 50865-710 HUMAN OTC DRUG Foaming Sanitizing Hand alcohol SOAP TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333E Kutol Products Company ALCOHOL .072 mg/mL E 20171231 50876-111_e52c45c0-5dea-4d96-91c6-ec981065ce13 50876-111 HUMAN OTC DRUG Cutiecaine Topical Lidocaine (4% w/w) CREAM TOPICAL 20100531 OTC MONOGRAPH NOT FINAL part348 Innovatech Inc LIDOCAINE HYDROCHLORIDE 40 mg/g E 20171231 50876-182_e7d4de92-2088-42c9-885f-e9845fa16c1d 50876-182 HUMAN OTC DRUG Cutiecaine Topical Lidocaine (4% w/w) CREAM TOPICAL 20100831 OTC MONOGRAPH NOT FINAL part348 Innovatech Inc BENZOCAINE; TETRACAINE 180; 20 mg/g; mg/g E 20171231 50881-005_a96f26e3-9241-4a94-a09a-58c2a66591c3 50881-005 HUMAN PRESCRIPTION DRUG JAKAFI ruxolitinib TABLET ORAL 20111116 NDA NDA202192 Incyte Corporation RUXOLITINIB 5 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 50881-010_a96f26e3-9241-4a94-a09a-58c2a66591c3 50881-010 HUMAN PRESCRIPTION DRUG JAKAFI ruxolitinib TABLET ORAL 20111116 NDA NDA202192 Incyte Corporation RUXOLITINIB 10 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 50881-015_a96f26e3-9241-4a94-a09a-58c2a66591c3 50881-015 HUMAN PRESCRIPTION DRUG JAKAFI ruxolitinib TABLET ORAL 20111116 NDA NDA202192 Incyte Corporation RUXOLITINIB 15 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 50881-020_a96f26e3-9241-4a94-a09a-58c2a66591c3 50881-020 HUMAN PRESCRIPTION DRUG JAKAFI ruxolitinib TABLET ORAL 20111116 NDA NDA202192 Incyte Corporation RUXOLITINIB 20 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 50881-025_a96f26e3-9241-4a94-a09a-58c2a66591c3 50881-025 HUMAN PRESCRIPTION DRUG JAKAFI ruxolitinib TABLET ORAL 20111116 NDA NDA202192 Incyte Corporation RUXOLITINIB 25 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 50914-7720_4ae21854-e93b-4550-b544-1e0a093d0e47 50914-7720 HUMAN PRESCRIPTION DRUG Volumex Iodinated I-131 Albumin INJECTION, SOLUTION INTRAVENOUS 19930801 NDA NDA017837 Iso-Tex Diagnostics, Inc. IODINATED I-131 SERUM ALBUMIN .025 mCi/mL Radiopharmaceutical Activity [MoA] N 20181231 50914-7729_e23f5f6f-c998-4735-a2cb-00364d83aff5 50914-7729 HUMAN PRESCRIPTION DRUG Glofil-125 Sodium Iothalamate I-125 injection INJECTION, SOLUTION INTRAVENOUS 19830501 NDA NDA017279 Iso-Tex Diagnostics, Inc. IOTHALAMATE SODIUM I-125 .275 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 50914-7731_78b13378-c056-4465-831e-fa8cb2e43332 50914-7731 HUMAN PRESCRIPTION DRUG Megatope Iodinated I-131 Albumin INJECTION, SOLUTION INTRAVENOUS 19900601 NDA NDA017837 Iso-Tex Diagnostics, Inc. IODINATED I-131 SERUM ALBUMIN 1 mCi/mL Radiopharmaceutical Activity [MoA] N 20181231 50914-7732_60803567-6a3e-4d0f-b019-30c8fa8dd71e 50914-7732 HUMAN PRESCRIPTION DRUG Jeanatope Iodinated I-125 Albumin INJECTION, SOLUTION INTRAVENOUS 19900601 NDA NDA017836 Iso-Tex Diagnostics, Inc. IODINATED I-125 SERUM ALBUMIN .01 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 50928-200_f909739e-721b-4554-a94c-b077ddf59571 50928-200 HUMAN OTC DRUG DooBony Mosrepel GLYCERIN LOTION TOPICAL 20100515 OTC MONOGRAPH FINAL part347 DOOBON INC GLYCERIN 2 mL/40mL E 20171231 50942-001_55fcce5a-74cd-4987-8a1f-05dafead0fc5 50942-001 HUMAN OTC DRUG XtraCare Antifungal Foot Tolnaftate SPRAY TOPICAL 20140211 OTC MONOGRAPH FINAL part333C Taizhou Ludao Cosmetics Co., Ltd. TOLNAFTATE 1 g/100g N 20181231 50942-002_5667105b-bd86-2246-e054-00144ff88e88 50942-002 HUMAN OTC DRUG Equate Liquid Foot Tolnaftate SPRAY TOPICAL 20140701 OTC MONOGRAPH FINAL part333C Zhejiang Ludao Cosmetics Co., Ltd. TOLNAFTATE 1 g/150g N 20181231 50942-003_cc3271d7-883d-4a8b-9881-bdc27dafac37 50942-003 HUMAN OTC DRUG Athletes Foot Tolnaftate SPRAY TOPICAL 20141104 OTC MONOGRAPH FINAL part333C Taizhou Ludao Cosmetics Co., Ltd. TOLNAFTATE 1 g/100g N 20181231 50942-008_526a9490-3a0c-5455-e054-00144ff88e88 50942-008 HUMAN OTC DRUG Antiperspirant Dry 2 oz Men Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20170501 OTC MONOGRAPH FINAL part350 Zhejiang Ludao Cosmetics Co., Ltd. ALUMINUM CHLOROHYDRATE 23 g/100g N 20181231 50942-009_5656a95e-e57d-3c88-e054-00144ff8d46c 50942-009 HUMAN OTC DRUG Antiperspirant Dry 2 oz Lady Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20170501 OTC MONOGRAPH FINAL part350 Rejoice International Inc. ALUMINUM CHLOROHYDRATE 23 g/100g N 20181231 50943-001_3b65d02e-38b1-4f67-8a30-fb7aa42d1ee2 50943-001 HUMAN OTC DRUG Top Medicated CAMPHOR (NATURAL), MENTHOL,METHYL SALICYLATE OIL TOPICAL 20120524 OTC MONOGRAPH FINAL part348 A&A Medical Supplies CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 10; 16; 50 mL/100mL; mL/100mL; mL/100mL N 20181231 50945-001_be9da7a0-9893-4844-a2c1-9d2e0bb4e036 50945-001 HUMAN OTC DRUG All Day Freshness Antibacterial Body Wash with Moisturizer Triclosan SOLUTION TOPICAL 20100815 OTC MONOGRAPH NOT FINAL part333E Diversapack of Monroe, LLC TRICLOSAN .15 g/100g E 20171231 50945-002_be9da7a0-9893-4844-a2c1-9d2e0bb4e036 50945-002 HUMAN OTC DRUG Gold Antibacterial Hand Soap with Moisturizer Triclosan SOLUTION TOPICAL 20100815 OTC MONOGRAPH NOT FINAL part333E Diversapack of Monroe, LLC TRICLOSAN .15 g/100g E 20171231 50950-001_797f6d37-d5f8-4915-8a7c-a700961acd4d 50950-001 HUMAN OTC DRUG Iman Time Control All Day Moisture Complex SPF 15 OCTINOXATE CREAM TOPICAL 20100810 OTC MONOGRAPH NOT FINAL part352 Sheencolor Biotech Co., Ltd. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g N 20181231 50950-002_119a0977-e6ea-4291-9035-3fa1c0c01997 50950-002 HUMAN OTC DRUG Iman Time Control Oil Free Moisture Complex SPF 15 OCTINOXATE CREAM TOPICAL 20100910 OTC MONOGRAPH NOT FINAL part352 Sheencolor Biotech Co., Ltd. OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g N 20181231 50952-001_cadd20c2-a235-431a-b13b-13fbc102e6cf 50952-001 HUMAN OTC DRUG Coolbottoms Diaper Rash Dimethicone CREAM TOPICAL 20100425 OTC MONOGRAPH FINAL part347 pH R&D LLC DIMETHICONE .57 g/57g E 20171231 50952-002_84104452-0a4d-47f2-a65d-c9c3fd85f9a8 50952-002 HUMAN OTC DRUG NeutrapHor Skin Protectant Dimethicone CREAM TOPICAL 20100425 OTC MONOGRAPH FINAL part347 pH R&D LLC DIMETHICONE .57 g/57g E 20171231 50952-003_8a3ce41f-e6c0-472f-868b-243d08962ad7 50952-003 HUMAN OTC DRUG NeutrapHorus Rex Skin Protectant Dimethicone CREAM TOPICAL 20101222 OTC MONOGRAPH FINAL part347 pH R&D LLC DIMETHICONE .57 g/57g E 20171231 50952-009_ffb4a90f-636c-4f00-9c17-4d95eb522718 50952-009 HUMAN OTC DRUG GoodStuff Skin Protectant Dimethicone CREAM TOPICAL 20130526 OTC MONOGRAPH FINAL part347 pH R&D LLC DIMETHICONE 10 mg/g E 20171231 50963-809_85c1ae7a-2e4c-41e4-8caf-f21e7ea0220c 50963-809 HUMAN OTC DRUG Motion Medicine Camphor, Menthol CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part348 Motion Medicine Inc. CAMPHOR (SYNTHETIC); MENTHOL 4; 4 g/100g; g/100g N 20181231 50964-010_a38de797-1191-4d34-9f28-1fed2ba36ada 50964-010 HUMAN OTC DRUG HAMSOA YUYU DIAPER WITCH HAZEL CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .07 g/70g N 20181231 50964-040_594b78f1-27ca-4564-a88f-b2c53cf45c4a 50964-040 HUMAN OTC DRUG HAMSOA ATOBY MEDI WITCH HAZEL LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .15 g/150mL N 20181231 50964-050_82953f70-5889-41a5-a1fe-c30ee09ebe43 50964-050 HUMAN OTC DRUG HAMSOA ATOBY MEDI WITCH HAZEL CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .05 g/50g N 20181231 50964-060_27b65d68-18d2-44d1-831c-133737698bd0 50964-060 HUMAN OTC DRUG HAMSOA YUYU DERMA119 BALM WITCH HAZEL CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .009 g/9g N 20181231 50964-070_2503b092-cf8f-4b75-9012-dd6aaed33244 50964-070 HUMAN OTC DRUG HAMSOA YUYU DERMA119 WITCH HAZEL CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .08 g/80g N 20181231 50964-090_5e52f1dc-51d1-4164-b910-347118f89c4a 50964-090 HUMAN OTC DRUG HAMSOA YUYU DEEP MOISTURE WITCH HAZEL LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part347 HAMSOA PHARMACEUTICAL CO., LTD. WITCH HAZEL .3 g/300mL N 20181231 50965-001_7b1b7e2a-21d9-4218-a0bf-bfd1325a627f 50965-001 HUMAN OTC DRUG stop hair Citric Acid Monohydrate SPRAY TOPICAL 20120701 UNAPPROVED DRUG OTHER Mila Beauty Pty Ltd CITRIC ACID MONOHYDRATE 7 mg/mL N 20181231 50965-123_71a538d9-d0af-4ddf-8bee-5673cf25371a 50965-123 HUMAN OTC DRUG stop hair Citric Acid Monohydrate SPRAY TOPICAL 20120901 UNAPPROVED DRUG OTHER STOP HAIR PTY LTD CITRIC ACID MONOHYDRATE .7 mg/100mL E 20171231 50967-126_3002c02d-94f5-42aa-ab3a-38fadd6fc777 50967-126 HUMAN PRESCRIPTION DRUG IROSPAN 24/6 IRON, FOLIC ACID, VITAMIN/MINERAL SUPPLEMENT KIT 20110415 UNAPPROVED DRUG OTHER WOMENS CHOICE PHARMACEUTICALS LLC E 20171231 50967-219_63d82922-1e02-47f5-a64e-e97e2e1ba4ad 50967-219 HUMAN PRESCRIPTION DRUG NESTABS Prenatal Multi-vitamin/Mineral Supplement Multi-vitamin/Mineral Supplement with Sodium Ascorbate, Cholecalciferol, di-alpha-Tocopheryl Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine HCL, Folic Acid, Cyanocobalamin, Calcium TABLET, FILM COATED ORAL 20110201 UNAPPROVED DRUG OTHER WOMENS CHOICE PHARMACEUTICALS LLC SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM FORMATE; CALCIUM CARBONATE; FERROUS BISGLYCINATE; POTASSIUM IODIDE; ZINC OXIDE; CHOLINE BITARTRATE 120; 450; 30; 3; 3; 20; 50; 1; 10; 155; 45; 32; 100; 10; 55 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 50967-309_641267b2-e086-450c-abeb-264755c8bc2b 50967-309 HUMAN PRESCRIPTION DRUG NESTABS ABC Prenatal Multi-vitamin/Mineral Supplement with DHA/EPA Sodium Ascorbate, Cholecalciferol, di-alpha-Tocopheryl Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine HCL, Folic Acid, Cyanocobalamin, Calcium Formate, Calcium Carbonate, Ferrous (II) bis-Glycinate Chelate, Potassium Iodide, Zinc Oxide, Choline Bitartrate, with doconexent and icosapent KIT 20131001 UNAPPROVED DRUG OTHER WOMENS CHOICE PHARMACEUTICALS LLC N 20181231 50967-317_bb5988d9-7098-4af8-8f04-2c55137a57ec 50967-317 HUMAN PRESCRIPTION DRUG NESTABS DHA Prenatal Multi-vitamin/Mineral Supplement with DHA/EPA Sodium Ascorbate, Cholecalciferol, di-alpha-Tocopheryl Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine HCL, Folic Acid, Cyanocobalamin, Calcium Formate, Calcium Carbonate, Ferrous ( KIT 20110201 UNAPPROVED DRUG OTHER WOMENS CHOICE PHARMACEUTICALS LLC E 20171231 50967-357_9eb11712-e770-42a2-a3af-1a98901c234d 50967-357 HUMAN PRESCRIPTION DRUG PROCORT 1.85% hydrocortisone acetate - 1.15% pramoxine hci cream CREAM TOPICAL 20110630 UNAPPROVED DRUG OTHER Womens Choice Pharmaceuticals LLC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 18.5; 11.5 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 50967-410_562c17d3-3b1a-42d1-e054-00144ff8d46c 50967-410 HUMAN PRESCRIPTION DRUG Nestabs ONE Vitamin C, Vitamin D, Vitamin E, Vitamin B6, Folate, Vitamin B12, Iron, Zinc, Magnesium, DHA CAPSULE, GELATIN COATED ORAL 20170720 UNAPPROVED DRUG OTHER Womens Choice Pharmaceuticals, LLC IRON; ZINC OXIDE; FOLIC ACID; ANTAZOLINE; TOCOPHEROL; CALCIUM ASCORBATE; CYANOCOBALAMIN; MAGNESIUM OXIDE; CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE 38; 1; 1; 225; 10; 18; 15; 15; 6.25; 30 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 50970-001_ac8d5688-c210-4410-8e27-5816216a8074 50970-001 HUMAN OTC DRUG e-HCG Fat Release System arginine, acetylcarnitine, l-, ornithine and human chorionic gonadotropin LIQUID ORAL 20100819 UNAPPROVED HOMEOPATHIC AnuMed International LLC ARGININE; ACETYLCARNITINE, L-; ORNITHINE; HUMAN CHORIONIC GONADOTROPIN 30; 30; 30; 60 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 50970-002_6b613a6f-64cc-4cda-88c4-27e839cc5e43 50970-002 HUMAN OTC DRUG e-HGH hGH somatropin LIQUID ORAL 20110501 UNAPPROVED HOMEOPATHIC AnuMed International LLC SOMATROPIN 6 [hp_C]/200mL E 20171231 50970-003_1049d373-8b88-49fa-a4ca-8461e8b24247 50970-003 HUMAN OTC DRUG IGF-1 Endurance Plus insulin-like growth factor-1 (IGF-1) LIQUID ORAL 20110501 UNAPPROVED HOMEOPATHIC AnuMed International LLC MECASERMIN 30 [hp_C]/30mL E 20171231 50972-272_6f37c3b4-486a-4419-a6de-a35797e630fd 50972-272 HUMAN OTC DRUG Arthritis Relief Menthol CREAM TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part348 NewMarket Health Products LLC MENTHOL 12.5 mg/g N 20181231 50972-273_5df4496e-e101-4e1c-bee1-ad22930ac7bf 50972-273 HUMAN OTC DRUG Arthritis Relief Menthol CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 NewMarket Health Products LLC MENTHOL 12.5 mg/g E 20171231 50972-274_761de70d-59dc-48f1-a248-f689de9a33c0 50972-274 HUMAN OTC DRUG Arthritis Relief Menthol CREAM TOPICAL 20171004 OTC MONOGRAPH NOT FINAL part348 NewMarket Health Products LLC MENTHOL 12.5 mg/mL N 20181231 50972-278_ae40b06d-2f5f-4b47-a887-54fc40f8422b 50972-278 HUMAN OTC DRUG ArthriPain Relief Menthol CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part348 NDI Solutions LLC MENTHOL 12.5 mg/g E 20171231 50972-300_4e785a4b-c840-3b57-e054-00144ff8d46c 50972-300 HUMAN OTC DRUG Arthritis Relief MENTHOL CREAM TOPICAL 20170429 OTC MONOGRAPH NOT FINAL part348 NewMarket Health Products LLC MENTHOL 12.5 mg/g N 20181231 50972-455_be7d9408-e09c-4c31-8839-d085d0bb8210 50972-455 HUMAN OTC DRUG Trienelle Skincare Instant Illusion Daily Renewal Creme Octinoxate 5%, Oxybenzone 4.5%, Avobenzone 3% CREAM TOPICAL 20140930 OTC MONOGRAPH NOT FINAL part352 NewMarket Health Products LLC OCTINOXATE; OXYBENZONE; AVOBENZONE 5; 4.5; 3 mg/g; mg/g; mg/g E 20171231 50972-736_0034d5d4-3de7-4dc5-be59-974c10940ca2 50972-736 HUMAN OTC DRUG Trienelle Skincare Daily Renewal Creme with Tocallure Restoration Complex Broad Spectrum SPF 15 Octinoxate 5%, Oxybezone 4.5%, Avobenzone 3% CREAM TOPICAL 20140929 OTC MONOGRAPH NOT FINAL part352 NewMarket Health Products LLC OCTINOXATE; OXYBENZONE; AVOBENZONE 5; 4.5; 3 mg/g; mg/g; mg/g E 20171231 50972-766_cc878010-66e4-4cd0-8282-33ef5142ff10 50972-766 HUMAN OTC DRUG Soothanol X2 Capsaicin and Menthol SOLUTION/ DROPS TOPICAL 20140611 OTC MONOGRAPH NOT FINAL part348 NewMarket Health Products LLC CAPSAICIN; MENTHOL 2; 120 mg/g; mg/g N 20181231 50973-1001_c6e34a76-e65a-406b-b4bd-e074b7a930fe 50973-1001 HUMAN OTC DRUG Okyongsoo NARDOSTACHYS CHINENSIS WHOLE LIQUID TOPICAL 20120618 UNAPPROVED DRUG OTHER Woori Health Promotion Town NARDOSTACHYS CHINENSIS WHOLE 1 mL/100mL E 20171231 50973-2001_d9bd3c2e-be29-4489-a2c1-0ab01f98e5cd 50973-2001 HUMAN OTC DRUG Okyong pack NARDOSTACHYS CHINENSIS WHOLE PASTE TOPICAL 20120618 UNAPPROVED DRUG OTHER Woori Health Promotion Town NARDOSTACHYS CHINENSIS WHOLE 1 mL/100mL E 20171231 50975-001_53930432-8f66-4865-8a8f-59d997cfaa01 50975-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Fox Welding Supply Inc OXYGEN 990 mL/L E 20171231 50975-011_e9b51081-bef8-4327-b9db-dbad9ef7c9d4 50975-011 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205865 Fox Welding Supply Inc OXYGEN 990 mL/L E 20171231 50980-056_fa27c641-6206-4e4e-893e-e9ce56515820 50980-056 HUMAN OTC DRUG Ben E.Keith Hand Cleaner Ethyl Alcohol GEL TOPICAL 20090102 OTC MONOGRAPH NOT FINAL part333 Ben E. Keith ETHANOL 62 mL/100mL E 20171231 50980-078_3e1f0531-1aa4-469f-a7dd-44d5126eb93d 50980-078 HUMAN OTC DRUG Ben E. Keith Antibacterial Hand Cleaner Triclosan LIQUID TOPICAL 20100618 OTC MONOGRAPH NOT FINAL part333 Ben E. Keith Foods TRICLOSAN .5 mL/100mL E 20171231 50980-682_adcad4ea-5459-45b4-b5e2-453c28c64064 50980-682 HUMAN OTC DRUG Ben E. Keith Foam Sanitizer Benzethonium Chloride LIQUID TOPICAL 20100102 OTC MONOGRAPH NOT FINAL part333A Ben E. Keith Foods BENZETHONIUM CHLORIDE .2 mL/100mL E 20171231 50980-689_442afcd9-a288-48d8-8671-9f0bc880cea8 50980-689 HUMAN OTC DRUG Ben E. Keith Foaming Antibacterial Hand Cleaner Triclosan LIQUID TOPICAL 20100102 OTC MONOGRAPH NOT FINAL part333A Ben E. Keith Foods TRICLOSAN .5 mL/100mL E 20171231 50988-150_a6e2b980-65cb-4499-8c89-3245a70b1810 50988-150 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100601 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-170_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-170 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-171_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-171 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-172_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-172 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-173_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-173 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-174_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-174 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-175_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-175 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-176_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-176 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-177_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-177 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-178_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-178 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-179_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-179 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20110515 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-180_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-180 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20110515 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-181_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-181 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-182_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-182 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-183_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-183 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-184_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-184 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-185_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-185 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-186_b29fe357-90f9-418a-a8c9-1ea76f29c296 50988-186 HUMAN OTC DRUG Antibacterial Foaming Hand Cleanser triclosan SOLUTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .869 mL/289.82mL E 20171231 50988-190_2220b62f-fed4-4304-9747-805f485be4ce 50988-190 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL E 20171231 50988-191_2220b62f-fed4-4304-9747-805f485be4ce 50988-191 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL E 20171231 50988-192_2220b62f-fed4-4304-9747-805f485be4ce 50988-192 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL E 20171231 50988-193_2220b62f-fed4-4304-9747-805f485be4ce 50988-193 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL E 20171231 50988-194_2220b62f-fed4-4304-9747-805f485be4ce 50988-194 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL E 20171231 50988-195_2220b62f-fed4-4304-9747-805f485be4ce 50988-195 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL E 20171231 50988-196_2220b62f-fed4-4304-9747-805f485be4ce 50988-196 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL E 20171231 50988-197_2220b62f-fed4-4304-9747-805f485be4ce 50988-197 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20101201 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL E 20171231 50988-198_2220b62f-fed4-4304-9747-805f485be4ce 50988-198 HUMAN OTC DRUG Antibacterial Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20101201 OTC MONOGRAPH FINAL part333E Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .055 mL/50.275mL E 20171231 50988-210_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-210 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL E 20171231 50988-211_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-211 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL E 20171231 50988-212_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-212 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL E 20171231 50988-213_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-213 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL E 20171231 50988-214_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-214 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL E 20171231 50988-215_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-215 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL E 20171231 50988-216_c089e2c4-d768-432a-8fdc-85d37a7d316e 50988-216 HUMAN OTC DRUG Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .994 mL/331.22mL E 20171231 50988-230_519f1a8e-a262-4e40-978e-b5553fb3666c 50988-230 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 E 20171231 50988-231_519f1a8e-a262-4e40-978e-b5553fb3666c 50988-231 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 E 20171231 50988-232_519f1a8e-a262-4e40-978e-b5553fb3666c 50988-232 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 E 20171231 50988-233_519f1a8e-a262-4e40-978e-b5553fb3666c 50988-233 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 E 20171231 50988-234_519f1a8e-a262-4e40-978e-b5553fb3666c 50988-234 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 E 20171231 50988-250_b168e9ae-501e-4a49-849d-298f75f12f82 50988-250 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 E 20171231 50988-251_b168e9ae-501e-4a49-849d-298f75f12f82 50988-251 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 E 20171231 50988-252_b168e9ae-501e-4a49-849d-298f75f12f82 50988-252 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 E 20171231 50988-253_b168e9ae-501e-4a49-849d-298f75f12f82 50988-253 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 E 20171231 50988-254_b168e9ae-501e-4a49-849d-298f75f12f82 50988-254 HUMAN OTC DRUG Antibacterial Hand Towelettes Ethyl Alcohol SWAB TOPICAL 20100803 OTC MONOGRAPH FINAL part333 Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/1 E 20171231 50988-270_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-270 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL E 20171231 50988-271_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-271 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20110411 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL E 20171231 50988-272_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-272 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL E 20171231 50988-273_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-273 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL E 20171231 50988-274_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-274 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL E 20171231 50988-275_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-275 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL E 20171231 50988-276_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-276 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL E 20171231 50988-277_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-277 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL E 20171231 50988-278_1d8ea7b6-6953-4176-85c2-1de2ac2978b4 50988-278 HUMAN OTC DRUG Anti-bacterial Hand Ethyl Alcohol GEL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. ALCOHOL 18.335 mL/29.574mL E 20171231 50988-280_f62761bb-26fb-41b6-99e0-69f321a3d636 50988-280 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-281_f62761bb-26fb-41b6-99e0-69f321a3d636 50988-281 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-282_f62761bb-26fb-41b6-99e0-69f321a3d636 50988-282 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-283_f62761bb-26fb-41b6-99e0-69f321a3d636 50988-283 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-284_71f0dead-1b4e-4ce4-8f15-9969c129cec1 50988-284 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-285_71f0dead-1b4e-4ce4-8f15-9969c129cec1 50988-285 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-286_71f0dead-1b4e-4ce4-8f15-9969c129cec1 50988-286 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-287_71f0dead-1b4e-4ce4-8f15-9969c129cec1 50988-287 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-288_25b02f75-73d9-4590-b020-5fd488a05328 50988-288 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120621 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-289_25b02f75-73d9-4590-b020-5fd488a05328 50988-289 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120621 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-290_26c4a966-78fa-4069-9f4a-dedff5ab972e 50988-290 HUMAN OTC DRUG Antibacterial Foaming Hand Benzalkonium Chloride SOLUTION TOPICAL 20120125 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .325 mL/295.74mL E 20171231 50988-291_26c4a966-78fa-4069-9f4a-dedff5ab972e 50988-291 HUMAN OTC DRUG Antibacterial Foaming Hand Benzalkonium Chloride SOLUTION TOPICAL 20120125 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .325 mL/295.74mL E 20171231 50988-292_26c4a966-78fa-4069-9f4a-dedff5ab972e 50988-292 HUMAN OTC DRUG Antibacterial Foaming Hand Benzalkonium Chloride SOLUTION TOPICAL 20120125 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .325 mL/295.74mL E 20171231 50988-293_26c4a966-78fa-4069-9f4a-dedff5ab972e 50988-293 HUMAN OTC DRUG Antibacterial Foaming Hand Benzalkonium Chloride SOLUTION TOPICAL 20120125 OTC MONOGRAPH NOT FINAL part333A Jets, Sets, & Elephants Beauty Corp. BENZALKONIUM CHLORIDE .325 mL/295.74mL E 20171231 50988-294_ce8fcd75-1c90-4c29-a1cb-2f81551c8bd3 50988-294 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Cleanser TRICLOSAN SOLUTION TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .3 mL/100mL E 20171231 50988-295_ce8fcd75-1c90-4c29-a1cb-2f81551c8bd3 50988-295 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Cleanser TRICLOSAN SOLUTION TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .3 mL/100mL E 20171231 50988-296_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-296 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL E 20171231 50988-297_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-297 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL E 20171231 50988-298_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-298 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL E 20171231 50988-299_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-299 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL E 20171231 50988-300_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-300 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL E 20171231 50988-301_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-301 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL E 20171231 50988-302_b6057e65-e3dd-4996-900b-33ad600ccfe8 50988-302 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Sanitizer TRICLOSAN GEL TOPICAL 20120807 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN 3 mg/mL E 20171231 50988-303_327d20bb-2f16-4b3d-8106-d877f47d53e3 50988-303 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Cleanser TRICLOSAN SOLUTION TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .3 mL/100mL E 20171231 50988-304_327d20bb-2f16-4b3d-8106-d877f47d53e3 50988-304 HUMAN OTC DRUG Shopko Antibacterial Foaming Hand Cleanser TRICLOSAN SOLUTION TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .3 mL/100mL E 20171231 50988-400_25b02f75-73d9-4590-b020-5fd488a05328 50988-400 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120621 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-401_25b02f75-73d9-4590-b020-5fd488a05328 50988-401 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120621 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-402_25b02f75-73d9-4590-b020-5fd488a05328 50988-402 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120621 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-405_d0004ee4-2da6-4750-bbd1-ca952444dcf7 50988-405 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-406_d0004ee4-2da6-4750-bbd1-ca952444dcf7 50988-406 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-407_d0004ee4-2da6-4750-bbd1-ca952444dcf7 50988-407 HUMAN OTC DRUG Shopko Antibacterial Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. ALCOHOL .62 mL/mL E 20171231 50988-450_da428ddd-de07-4b5d-ab9b-1de508ba7957 50988-450 HUMAN OTC DRUG Shopko Antibacterial Deep Cleansing Hand Triclosan GEL TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .2 mL/100mL E 20171231 50988-451_da428ddd-de07-4b5d-ab9b-1de508ba7957 50988-451 HUMAN OTC DRUG Shopko Antibacterial Deep Cleansing Hand Triclosan GEL TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .2 mL/100mL E 20171231 50988-452_da428ddd-de07-4b5d-ab9b-1de508ba7957 50988-452 HUMAN OTC DRUG Shopko Antibacterial Deep Cleansing Hand Triclosan GEL TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .2 mL/100mL E 20171231 50988-453_da428ddd-de07-4b5d-ab9b-1de508ba7957 50988-453 HUMAN OTC DRUG Shopko Antibacterial Deep Cleansing Hand Triclosan GEL TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .2 mL/100mL E 20171231 50988-454_da428ddd-de07-4b5d-ab9b-1de508ba7957 50988-454 HUMAN OTC DRUG Shopko Antibacterial Deep Cleansing Hand Triclosan GEL TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part333E Jets, Sets, & Elephants Beauty Corp. TRICLOSAN .2 mL/100mL E 20171231 50991-114_7111cf75-c4f5-4ba2-8ef8-e1ba034f14d3 50991-114 HUMAN OTC DRUG POLY-TUSSIN D Chlorcyclizine Hydrochloride, Codeine Phosphate, Pseudoephedrine Hydrochloride LIQUID ORAL 20120918 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals CHLORCYCLIZINE HYDROCHLORIDE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 9.375; 10; 30 mg/5mL; mg/5mL; mg/5mL CV E 20171231 50991-212_a5adcdb9-ad24-4455-ab29-d5514660a853 50991-212 HUMAN OTC DRUG Poly-Vent IR Guaifenesin and Pseudoephedrine HCl TABLET ORAL 20130611 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 380; 60 mg/1; mg/1 N 20181231 50991-214_f0ce3345-e0be-4a54-b7e0-e87b0cdcf00e 50991-214 HUMAN OTC DRUG Poly-Vent DM Dextromethorphan HBr, Guaifenesin and Pseudoephedrine HCl TABLET ORAL 20130617 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 380; 20; 60 mg/1; mg/1; mg/1 N 20181231 50991-216_e5c32d5e-0943-4f91-a468-f66fd1545332 50991-216 HUMAN OTC DRUG Poly Hist Forte Doxylamine Succinate and Phenylephrine Hydrochloride TABLET ORAL 20131001 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 7.5; 10 mg/1; mg/1 N 20181231 50991-220_347ea3ee-998c-46a6-9e1d-67b1875a8361 50991-220 HUMAN OTC DRUG Poly-Hist DM Dextromethorphan Hydrobromide, Phenylephrine HCl and Thonzylamine HCl LIQUID ORAL 20130622 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE 10; 5; 25 mg/5mL; mg/5mL; mg/5mL N 20181231 50991-222_65303547-470a-42fb-85ef-031210b0bda5 50991-222 HUMAN OTC DRUG Poly Hist PD Thonzylamine Hydrochloride and Chlophedianol Hydrochloride LIQUID ORAL 20130701 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. THONZYLAMINE HYDROCHLORIDE; CHLOPHEDIANOL HYDROCHLORIDE 6.25; 6.25 mg/mL; mg/mL N 20181231 50991-323_6ba903a8-6be6-4bef-9f77-f3cf6fa38d44 50991-323 HUMAN OTC DRUG Foltrate Folic Acid and Cyanocobalamin TABLET, FILM COATED ORAL 20100826 UNAPPROVED DRUG OTHER Poly Pharmaceuticals, Inc. FOLIC ACID; CYANOCOBALAMIN 1; 500 mg/1; ug/1 N 20181231 50991-492_5f006df2-adba-3a60-e053-2a91aa0ab206 50991-492 HUMAN OTC DRUG Polytussin DM DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl SYRUP ORAL 20171122 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 10; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 50991-528_a7e1a8cb-7c59-407c-975c-177f8386a690 50991-528 HUMAN OTC DRUG Poly Hist NC Codeine Phosphate, Pseudoephedrine Hydrochloride and Triprolidine Hydrochloride LIQUID ORAL 20100101 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 10; 15; 1.25 mg/mL; mg/mL; mg/mL CV N 20181231 50991-535_3f767a59-37fc-4646-ab6b-d571b1f0962c 50991-535 HUMAN OTC DRUG Duraflu ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl TABLET ORAL 20151001 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 325; 20; 200; 60 mg/1; mg/1; mg/1; mg/1 N 20181231 50991-578_9c1638e4-b634-49d1-8fc4-a187e280d82e 50991-578 HUMAN PRESCRIPTION DRUG IBUDONE hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20061106 ANDA ANDA077727 Poly Pharmaceuticals HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 50991-579_9c1638e4-b634-49d1-8fc4-a187e280d82e 50991-579 HUMAN PRESCRIPTION DRUG IBUDONE hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20061106 ANDA ANDA077723 Poly Pharmaceuticals HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 50991-582_5c441a30-38ef-4e2d-9c11-b49d647e340a 50991-582 HUMAN OTC DRUG DECONEX Guaifenesin, Phenylephrine Hydrochloride CAPSULE ORAL 20120207 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 390; 10 mg/1; mg/1 E 20171231 50991-583_0b429b11-e8a8-4bbc-a7c3-1afcaff547d6 50991-583 HUMAN OTC DRUG DECONEX DM Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride CAPSULE ORAL 20120208 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 390; 10 mg/1; mg/1; mg/1 E 20171231 50991-597_63857ec2-106a-4e39-bdc2-b15a4a0d3ff1 50991-597 HUMAN OTC DRUG LORTUSS LQ Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 20110222 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 6.25; 30 mg/5mL; mg/5mL E 20171231 50991-598_1522ab60-416a-4d09-8552-833b321a92e6 50991-598 HUMAN OTC DRUG LORTUSS DM Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 20110314 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 6.25 mg/5mL; mg/5mL E 20171231 50991-607_d6135456-8e0d-48d2-8cad-db2ff4538947 50991-607 HUMAN OTC DRUG Alahist LQ Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride LIQUID ORAL 20071220 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 25; 7.5 mg/5mL; mg/5mL E 20171231 50991-716_f89eecf1-cfe2-4c10-bca7-422527c34a4c 50991-716 HUMAN OTC DRUG DECONEX IR Guaifenesin, Phenylephrine Hydrochloride TABLET ORAL 20120225 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 380; 10 mg/1; mg/1 E 20171231 50991-723_ca365aa2-9172-4ce7-8456-33c7fdf78d05 50991-723 HUMAN OTC DRUG Poly-Tussin AC Brompheniramine Maleate, Codeine Phosphate, Phenylephrine Hydrochloride LIQUID ORAL 20140602 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10; 10 mg/5mL; mg/5mL; mg/5mL CV N 20181231 50991-730_e1996026-948f-472b-a73d-3d761cb748a9 50991-730 HUMAN OTC DRUG DECONEX DMX Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET ORAL 20120217 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 380; 10 mg/1; mg/1; mg/1 E 20171231 50991-736_901f9705-e4e1-4713-97d5-dde06f5f447b 50991-736 HUMAN OTC DRUG Deconex IR Guaifenesin and Phenylephrine HCl TABLET ORAL 20160808 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 385; 10 mg/1; mg/1 N 20181231 50991-738_5493a3fe-34e5-4247-b6b7-c2c9da2fbe84 50991-738 HUMAN OTC DRUG Deconex DMX Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET ORAL 20160808 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 17.5; 385; 10 mg/1; mg/1; mg/1 N 20181231 50991-782_01d5e656-8869-4f31-a600-93abb5f9b028 50991-782 HUMAN OTC DRUG ALA-HIST PE Phenylephrine Hydrochloride, Dexbrompheniramine Maleate TABLET ORAL 20110915 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. PHENYLEPHRINE HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE 10; 2 mg/1; mg/1 N 20181231 50991-783_4206358d-9bab-49fa-9e14-d825e77deb08 50991-783 HUMAN OTC DRUG ALA-HIST IR Dexbrompheniramine Maleate TABLET ORAL 20110822 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DEXBROMPHENIRAMINE MALEATE 2 mg/1 N 20181231 50991-784_59774c8a-deb0-53a6-e053-2991aa0a709f 50991-784 HUMAN OTC DRUG Alahist CF dexbrompheniramine maleate, dextromethorphan Hbr, Phenylephrine Hcl TABLET ORAL 20170914 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 20; 10 g/1; g/1; g/1 N 20181231 50991-814_30bd7389-43e7-4850-805b-cc5f3c1977b0 50991-814 HUMAN OTC DRUG ALAHIST DM Brompheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide LIQUID ORAL 20071227 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 4; 7.5; 15 mg/5mL; mg/5mL; mg/5mL E 20171231 50991-826_1073b5c0-9b6b-4485-b6a6-935742c6c865 50991-826 HUMAN OTC DRUG ALAHISTDM DM Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20160901 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals, Inc. DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 15; 7.5 mg/5mL; mg/5mL; mg/5mL N 20181231 50991-901_eb9b8199-a013-48fe-9dc7-2bd82c72a087 50991-901 HUMAN OTC DRUG ALA-HIST AC Codeine Phosphate, Phenylephrine Hydrochloride LIQUID ORAL 20071221 OTC MONOGRAPH FINAL part341 Poly Pharmaceuticals CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE 10; 7.5 mg/5mL; mg/5mL CV E 20171231 50996-001_8e0b24f8-0f26-4ef6-829f-e88a4797c716 50996-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20100602 UNAPPROVED MEDICAL GAS Smith's Drugs fo Forest City, Inc. dba Smith Drugs OXYGEN 99 L/100L E 20171231 51004-0053_6d411f9f-9f58-4485-a156-75319af82d9f 51004-0053 HUMAN PRESCRIPTION DRUG Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20130731 ANDA ANDA088387 Novocol Pharmaceutical of Canada, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 51004-0550_bf13c71d-bcf8-4d7e-a588-15c34b9830df 51004-0550 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088389 Novocol Pharmaceutical of Canada, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .02 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 51004-1051_553c5066-3cba-4c73-a2db-9f18291c15ed 51004-1051 HUMAN PRESCRIPTION DRUG LIDOCAINE Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 Novocol Pharmaceutical of Canada, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 51004-1095_ee2c519b-e285-4bde-81ed-f109f64088a7 51004-1095 HUMAN PRESCRIPTION DRUG Lignospan Standard Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111015 ANDA ANDA088390 Novocol Pharmaceutical of Canada, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 51004-1096_0dc2796a-c3b3-48f3-b5e3-277d7646ca54 51004-1096 HUMAN PRESCRIPTION DRUG Lignospan Forte Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111015 ANDA ANDA088389 Novocol Pharmaceutical of Canada, Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 20; .02 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 51004-1097_59fcd689-a6a3-4739-a982-6b41c249de7b 51004-1097 HUMAN PRESCRIPTION DRUG Scandonest L Mepivacaine Hydrochloride and Levonordefrin INJECTION, SOLUTION SUBCUTANEOUS 20130627 ANDA ANDA088388 Novocol Pharmaceutical of Canada, Inc MEPIVACAINE HYDROCHLORIDE; LEVONORDEFRIN 20; .05 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 51004-1098_9832a4f7-24d4-46f8-9099-1928c0e79b49 51004-1098 HUMAN PRESCRIPTION DRUG Scandonest Plain Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20130626 ANDA ANDA088387 Novocol Pharmaceutical of Canada, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 51004-2010_ba7ff05c-cdd8-4f17-a908-8e847ea35a75 51004-2010 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine Bitartrate Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 Novocol Pharmaceutical of Canada, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 51004-2020_163ceaa4-f528-4a64-8515-3e98fe208856 51004-2020 HUMAN PRESCRIPTION DRUG Isocaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20100820 ANDA ANDA088387 Novocol Pharmaceutical of Canada, Inc. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 51009-001_77266f5a-205d-4fb0-ab47-53ddc9eaa2ac 51009-001 HUMAN OTC DRUG Anticavity Juicy mint Sodium Fluoride RINSE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .46277 mg/mL N 20181231 51009-100_3452f64a-225d-428c-95d3-df5bd9c8d826 51009-100 HUMAN OTC DRUG Whole Care Cinnamon Clove Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-104_3452f64a-225d-428c-95d3-df5bd9c8d826 51009-104 HUMAN OTC DRUG Whole Care Peppermint Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-105_3452f64a-225d-428c-95d3-df5bd9c8d826 51009-105 HUMAN OTC DRUG Whole Care Spearmint Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-106_3452f64a-225d-428c-95d3-df5bd9c8d826 51009-106 HUMAN OTC DRUG Whole Care Wintermint Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-107_9302cac5-ef68-484a-b3ee-d120b4be4587 51009-107 HUMAN OTC DRUG Clean and Gentle Peppermint Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-111_435be901-9138-40ff-9010-86db6e6105da 51009-111 HUMAN OTC DRUG Cavity Protection Wintermint Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-116_873dc868-9a54-452c-ae24-e090e8464a05 51009-116 HUMAN OTC DRUG Cavity Protection Spearmint Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-119_6381cc75-dba7-4ace-a16b-2ebe41b0d880 51009-119 HUMAN OTC DRUG Whole Care Orange Mango Sodium fluoride PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g N 20181231 51009-120_873dc868-9a54-452c-ae24-e090e8464a05 51009-120 HUMAN OTC DRUG Cavity Protection Peppermint with baking soda Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-127_14754960-8e32-4c3c-b41d-f5ed6fdc2c74 51009-127 HUMAN OTC DRUG Childrens Outrageous Orange Mango Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-128_81c745f1-4123-4e7a-9808-864dc83aab26 51009-128 HUMAN OTC DRUG Childrens Silly Strawberry Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-145_2b78fb8e-26c2-45b4-9a62-ba0eef379244 51009-145 HUMAN OTC DRUG Long-Lasting Wicked Fresh - Spearmint Ice Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20091130 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-145_380e2556-177d-4937-b2d1-7e3f8f819c80 51009-145 HUMAN OTC DRUG Long-Lasting Wicked Fresh - Spearmint Ice Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110506 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-146_380e2556-177d-4937-b2d1-7e3f8f819c80 51009-146 HUMAN OTC DRUG Long-Lasting Wicked Fresh - Cool Peppermint Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20110506 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-146_9ec12240-a65a-4f5d-8059-f33e5b283adc 51009-146 HUMAN OTC DRUG Long-Lasting Wicked Fresh - Cool Peppermint Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20091130 OTC MONOGRAPH FINAL part335 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-148_2aae47ad-fe31-4232-b786-bf5cf28f5fe0 51009-148 HUMAN OTC DRUG Simply White clean mint Sodium fluoride PASTE, DENTIFRICE DENTAL 20110204 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .0024 g/g N 20181231 51009-149_bd7d3ba3-496f-4a16-a3fb-619c37a922e4 51009-149 HUMAN OTC DRUG Simply White sweet mint Sodium fluoride PASTE, DENTIFRICE DENTAL 20100312 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .0024 g/g N 20181231 51009-153_6381cc75-dba7-4ace-a16b-2ebe41b0d880 51009-153 HUMAN OTC DRUG Whole Care Spearmint Sodium fluoride PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g N 20181231 51009-158_6381cc75-dba7-4ace-a16b-2ebe41b0d880 51009-158 HUMAN OTC DRUG Whole Care Peppermint Sodium fluoride PASTE, DENTIFRICE DENTAL 20110214 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g N 20181231 51009-166_b5fa22e2-cc30-488b-8527-87ed98a19680 51009-166 HUMAN OTC DRUG Maximum Strength Sensitive Soothing Mint Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20090901 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE; POTASSIUM NITRATE .00243; .05 g/g; g/g N 20181231 51009-167_09b91597-8edd-4f22-8770-3a2ae93cc4a5 51009-167 HUMAN OTC DRUG Maximum Strength Sensitive True Mint Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20090901 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE; POTASSIUM NITRATE .00243; .05 g/g; g/g N 20181231 51009-197_b63b75f1-6d22-4920-ae5f-cd9a1bacab3f 51009-197 HUMAN OTC DRUG Sensitive fluoride-free - Wintermint Potassium Nitrate PASTE, DENTIFRICE DENTAL 20090901 OTC MONOGRAPH NOT FINAL part356 Tom's of Maine, Inc. POTASSIUM NITRATE .05 g/g N 20181231 51009-198_ca0bfc99-fb07-418a-a697-d627885a7107 51009-198 HUMAN OTC DRUG Toms Natural Anticavity Peppermint fights cavities freshens breath strengthens enamel Sodium fluoride PASTE, DENTIFRICE DENTAL 20140101 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g N 20181231 51009-199_82a79e8e-49e9-41f1-b83e-685efdb96ace 51009-199 HUMAN OTC DRUG Toms Cavity Protection Spearmint Fights cavities / Fresh Breath Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130220 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-202_ee8d238d-0c22-4e28-8c4b-8500866ab906 51009-202 HUMAN OTC DRUG Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20140606 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-203_2d19f12a-1cb1-4766-9ea7-c694ffc57476 51009-203 HUMAN OTC DRUG Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20140606 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-205_6eb37d0d-c8a5-44a4-a6c4-cd9d1842c1a7 51009-205 HUMAN OTC DRUG Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20140606 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-206_cffc1051-b891-47f1-b0e6-eee03ed7bb08 51009-206 HUMAN OTC DRUG Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20140606 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-207_43932082-d9ce-47cf-8a64-f3d691b27df5 51009-207 HUMAN OTC DRUG Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20140812 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-208_50c5f792-e0bf-4bb8-b33c-3c675c611034 51009-208 HUMAN OTC DRUG Toms Whole Care Peppermint fights cavities / whitening / fresh breath / helps fight tartar Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20140811 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-209_76a4c57e-afb9-4556-811b-0b5bf11d331f 51009-209 HUMAN OTC DRUG Toms Natural Enamel Strength Peppermint strengthens enamel / whitening / fights cavities / freshens breath / no artificial dyes or sweeteners Sodium fluoride PASTE, DENTIFRICE DENTAL 20141217 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g N 20181231 51009-210_a0082742-a915-4dd6-a1e9-c4f426dffad4 51009-210 HUMAN OTC DRUG Toms Cavity Protection Spearmint Fights cavities Fresh Breath Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20141231 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-211_c767c7f6-afb6-4d06-9d65-7471585f4e12 51009-211 HUMAN OTC DRUG Toms Baking Soda Cavity Protection Peppermint Fights cavities / Fresh Breath Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20141231 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-212_d8e1c2c7-aa0b-4f7b-a83e-dde37563030a 51009-212 HUMAN OTC DRUG Toms Whole Care Wintermint fights cavities / whitening / fresh breath / helps fight tartar / no artificial dyes or sweeteners Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20150301 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-213_05e65026-e74d-42c8-a6be-ce3b0f6d685f 51009-213 HUMAN OTC DRUG Toms Natural Maximum Strength Sensitive Soothing Mint clinically proven to reduce painful sensitivity / no artificial dyes or sweeteners Potassium Nitrate and Sodium fluoride PASTE, DENTIFRICE DENTAL 20150301 OTC MONOGRAPH NOT FINAL part356 Tom's of Maine, Inc. POTASSIUM NITRATE; SODIUM FLUORIDE .05; .00243 g/g; g/g N 20181231 51009-214_20f4163f-a2ca-4022-b30a-fa3c730ddb08 51009-214 HUMAN OTC DRUG Toms Natural Fluoride-free Strength Sensitive Wintermint clinically proven to reduce painful sensitivity / no artificial dyes or sweeteners Potassium Nitrate PASTE, DENTIFRICE DENTAL 20150501 OTC MONOGRAPH NOT FINAL part356 Tom's of Maine, Inc. POTASSIUM NITRATE .05 g/g N 20181231 51009-215_0f1bfc7a-ea93-4a6f-bbeb-4a78c26b35c2 51009-215 HUMAN OTC DRUG Toms Childrens Fluoride Silly Strawberry Prevents cavities / tastes great / dye free Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20150401 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-216_fb83396c-8d4a-4ce3-b427-80e87cf34add 51009-216 HUMAN OTC DRUG Toms Simply White Fluoride Clean Mint whitening / cavity protection Sodium fluoride PASTE, DENTIFRICE DENTAL 20150401 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g N 20181231 51009-217_2af6fc39-ce2c-47f6-a1b2-c06870a33318 51009-217 HUMAN OTC DRUG Toms Wicked Cool Fluoride - Mild Mint fights cavities / strengthens enamel / freshens breath / dye free Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20150401 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-218_4e865398-7e33-4942-b993-69af18032f16 51009-218 HUMAN OTC DRUG Toms Luminous White Fluoride Clean Mint cavity protection / whitening Sodium fluoride PASTE, DENTIFRICE DENTAL 20151201 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g N 20181231 51009-219_2536ec94-112b-44c1-b743-8db294dafb3e 51009-219 HUMAN OTC DRUG Toms Whole Care Cinnamon Clove fights cavities whitening fresh breath helps fight tartar Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20160712 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 51009-220_f05aa687-47ce-47ed-a974-4d224c4ca42c 51009-220 HUMAN OTC DRUG Toms Luminous White - Spearmint fights cavities whitening Sodium fluoride PASTE, DENTIFRICE DENTAL 20161201 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g N 20181231 51009-238_15428dec-613d-4894-a015-7035b4584509 51009-238 HUMAN OTC DRUG Natural Fluoride Fresh Mint cavity protection whitening fresh breath Sodium fluoride PASTE, DENTIFRICE DENTAL 20120901 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g N 20181231 51009-248_8a3b9499-da8c-4c43-ad4c-6cb02976d175 51009-248 HUMAN OTC DRUG Simply White clean mint Sodium fluoride PASTE, DENTIFRICE DENTAL 20110829 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM FLUORIDE .00243 g/g N 20181231 51009-701_16f38271-5574-4fe0-a267-7e4be54f553e 51009-701 HUMAN OTC DRUG Toms Baby Diaper Fragrance Free Zinc Oxide CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part347 Tom's of Maine ZINC OXIDE .12 g/g N 20181231 51009-702_ee53ffad-a36e-4e47-b93f-19cc7124657d 51009-702 HUMAN OTC DRUG Toms Baby Sunscreen Fragrance Free Sunscreen Zinc Oxide CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Tom's of Maine ZINC OXIDE .2 g/g N 20181231 51009-830_14754960-8e32-4c3c-b41d-f5ed6fdc2c74 51009-830 HUMAN OTC DRUG Childrens Outrageous Orange Mango Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20100830 OTC MONOGRAPH FINAL part355 Tom's of Maine, Inc. SODIUM MONOFLUOROPHOSPHATE .0076 g/g N 20181231 51009-831_aca9d974-5e3b-4f01-ac01-9a5a516e4ff6 51009-831 HUMAN OTC DRUG Naturally Dry Natural Aluminum chlorohydrate STICK CUTANEOUS 20120102 OTC MONOGRAPH FINAL part350 Tom's of Maine, Inc. ALUMINUM CHLOROHYDRATE .22 g/g N 20181231 51009-832_621e453c-5ee1-48ce-9d01-5e6a6a4627c1 51009-832 HUMAN OTC DRUG Naturally Dry Unscented Aluminum chlorohydrate STICK CUTANEOUS 20120102 OTC MONOGRAPH FINAL part350 Tom's of Maine, Inc. ALUMINUM CHLOROHYDRATE .23 g/g N 20181231 51009-833_f4ad703d-cb7f-4b00-93ad-4fca5df02f1a 51009-833 HUMAN OTC DRUG Toms Naturally Dry Antiperspirant Deodorant - Fresh Meadow wetness protection Aluminum Chlorohydrate STICK CUTANEOUS 20141115 OTC MONOGRAPH FINAL part350 Tom's of Maine, Inc. ALUMINUM CHLOROHYDRATE .22 g/g N 20181231 51009-834_ace5f069-350c-419f-bb2f-f0e6de6ab296 51009-834 HUMAN OTC DRUG Toms Naturally Dry Antiperspirant Deodorant - Northwoods wetness protection Aluminum Chlorohydrate STICK CUTANEOUS 20151130 OTC MONOGRAPH FINAL part350 Tom's of Maine, Inc. ALUMINUM CHLOROHYDRATE .22 g/g N 20181231 51009-835_1c9ef734-bafd-4038-8570-f8bd2ee47bf8 51009-835 HUMAN OTC DRUG Toms of Maine Antiperspirant Deodorant - Coconut Lavender Wetness Protection Aluminum Chlorohydrate STICK TOPICAL 20171101 OTC MONOGRAPH FINAL part350 Tom's of Maine, Inc. ALUMINUM CHLOROHYDRATE .22 g/g N 20181231 51012-001_c1852e9f-1c58-4ec7-9bb2-31c1f6d504bf 51012-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20090101 NDA NDA205849 Gilmore Liquid Air Company OXYGEN 99 L/100L N 20191231 51012-002_a0098111-c7bd-4859-8e1b-d8f4d4c08077 51012-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20090101 NDA NDA205850 Gilmore Liquid Air Company NITROGEN 99 L/100L N 20191231 51012-003_886c310c-c30d-4365-bcce-a9bf26f33d37 51012-003 HUMAN PRESCRIPTION DRUG AIR AIR GAS RESPIRATORY (INHALATION) 20090101 NDA NDA205909 Gilmore Liquid Air Company AIR 20.5 L/100L N 20191231 51013-103_82b77390-3308-4b92-8b69-42dd6c0c2b4c 51013-103 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20161012 ANDA ANDA206568 PuraCap Pharmaceutical LLC IBUPROFEN 200 mg/1 N 20181231 51013-104_5e161f46-53d0-49e8-abac-8d1b6326ece0 51013-104 HUMAN OTC DRUG Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20150526 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 51013-106_60e1b20c-a0b7-90ed-e053-2a91aa0a5056 51013-106 HUMAN OTC DRUG NiteTime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20141226 20181130 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 51013-107_60e1b2fb-646b-badf-e053-2a91aa0a9a55 51013-107 HUMAN OTC DRUG Pain Relief Extra Strength ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20141120 20190630 OTC MONOGRAPH NOT FINAL part343 PuraCap Pharmaceutical LLC ACETAMINOPHEN 500 mg/1 N 20181231 51013-109_b08f246d-4f61-4120-95c9-adf40596ed5f 51013-109 HUMAN OTC DRUG Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20160713 OTC MONOGRAPH FINAL part332 PuraCap Pharmaceutical LLC DIMETHICONE 125 mg/1 N 20181231 51013-110_f449d738-df72-402a-91cc-eb09a685237d 51013-110 HUMAN OTC DRUG Maximum Strength Nighttime Cold/Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCI CAPSULE, LIQUID FILLED ORAL 20160221 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-111_9a202385-22e5-4f7d-965a-78b9a5898722 51013-111 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM 50 MG DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140822 OTC MONOGRAPH NOT FINAL part334 PuraCap Pharmaceutical LLC DOCUSATE SODIUM 50 mg/1 N 20181231 51013-114_652546fd-1147-4fed-bfb0-9b26843b1d78 51013-114 HUMAN OTC DRUG Daytime Sinus Relief and Nighttime Sinus Relief acetaminophen, doxylamine succinate, phenylephrine hydrochloride KIT 20160802 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC N 20181231 51013-115_7b6027bd-a8f8-4872-8dff-2695745f819b 51013-115 HUMAN OTC DRUG Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20160715 OTC MONOGRAPH FINAL part332 PuraCap Pharmaceutical LLC DIMETHICONE 180 mg/1 N 20181231 51013-117_be0bf6ef-9a0c-4ec6-a46b-4c68b8e93613 51013-117 HUMAN OTC DRUG CVS Daytime COLD and FLU RELIEF and Nighttime COLD and FLU RELIEF acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride KIT 20160630 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC N 20181231 51013-118_a361d529-66eb-4816-8687-f0c2074306a2 51013-118 HUMAN OTC DRUG DAY Cold and Flu Plus and NIGHTTIME Cold and Flu Plus acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride KIT 20160728 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC N 20181231 51013-120_797c2de1-40a3-4ca3-941d-5a7556b89792 51013-120 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20161002 OTC MONOGRAPH NOT FINAL part334 PuraCap Pharmaceutical LLC DOCUSATE SODIUM 100 mg/1 N 20181231 51013-122_db5a188c-0cca-4d19-b8d7-940b0aeef723 51013-122 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20160601 OTC MONOGRAPH NOT FINAL part334 PuraCap Pharmaceutical LLC DOCUSATE SODIUM 100 mg/1 N 20181231 51013-122_e6ddf54c-2c78-4a20-a220-d83e30da7419 51013-122 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20160630 OTC MONOGRAPH NOT FINAL part334 PuraCap Pharmaceutical LLC DOCUSATE SODIUM 100 mg/1 N 20181231 51013-123_0feaf992-2a4c-44f1-81a1-62558ef12c83 51013-123 HUMAN OTC DRUG Ultra Strength Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20170717 OTC MONOGRAPH FINAL part332 PuraCap Pharmaceutical LLC DIMETHICONE 180 mg/1 N 20181231 51013-124_84c36d06-1c3c-412e-8b10-9c0bb08cd94b 51013-124 HUMAN OTC DRUG DayTime and NiteTime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride KIT 20160627 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC N 20181231 51013-125_a7a9fb34-72fe-4e22-b913-c57648d7a20e 51013-125 HUMAN OTC DRUG Cough Relief DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20160701 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 51013-127_988038a5-f0ad-4884-bc5d-3ba4cbe44218 51013-127 HUMAN OTC DRUG Maximum Strength Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20160111 OTC MONOGRAPH FINAL part332 PURACAP PHARMACEUTICAL LLC DIMETHICONE 250 mg/1 N 20181231 51013-128_374b031d-c557-4df0-ae79-f22628e04999 51013-128 HUMAN OTC DRUG EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20160712 OTC MONOGRAPH NOT FINAL part343 PuraCap Pharmaceutical LLC ACETAMINOPHEN 500 mg/1 N 20181231 51013-129_6b570567-d92f-46f8-85b2-16022e4bc502 51013-129 HUMAN OTC DRUG Night Time Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160505 OTC MONOGRAPH FINAL part338 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 51013-130_17a61e95-2355-4419-ad2a-65dcaf1a7d6f 51013-130 HUMAN OTC DRUG DAYTIME COLD and FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20160630 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 51013-131_31efba1f-92f8-4a25-8c95-53732d5b27b3 51013-131 HUMAN OTC DRUG NIGHTTIME COLD and FLU acetaminophen, dextromethorphan hydrobromide, doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20160630 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 51013-132_db03b7a1-354b-4ee0-aafa-e0149c1903dc 51013-132 HUMAN OTC DRUG Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20160726 OTC MONOGRAPH FINAL part332 PuraCap Pharmaceutical LLC DIMETHICONE 125 mg/1 N 20181231 51013-134_c6d9eec8-499c-422f-96f4-114ed867778f 51013-134 HUMAN OTC DRUG DayTime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20160426 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 51013-135_5f804c67-f41d-423c-b125-b03dd02443e4 51013-135 HUMAN OTC DRUG Nite Time Cold and Flu Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide CAPSULE, LIQUID FILLED ORAL 20171219 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-136_60cb89f6-e315-0773-e053-2a91aa0a33dd 51013-136 HUMAN OTC DRUG Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20160714 20191031 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 51013-138_4831a583-6823-4121-824b-6151397463f4 51013-138 HUMAN OTC DRUG Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160720 OTC MONOGRAPH FINAL part338 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 51013-141_ea6e8386-4b69-4e10-93a9-f431dfb50d1b 51013-141 HUMAN OTC DRUG DDM Day time and Nite time cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride KIT 20160620 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC N 20181231 51013-142_241e34f3-3459-42a2-a1bf-689f16e38b9d 51013-142 HUMAN OTC DRUG Nighttime SLEEP AID Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160630 OTC MONOGRAPH FINAL part338 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 51013-142_f8095563-5b00-469e-a4e8-c57155b69489 51013-142 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160601 OTC MONOGRAPH FINAL part338 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 51013-143_a3fd4d29-15d3-4883-919c-5eba0fe076b8 51013-143 HUMAN OTC DRUG DAY TIME COLD and FLU FORMULA ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20160714 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 51013-144_38f0a8b9-f9fe-4d3e-b1bb-bebd5d4ab7d4 51013-144 HUMAN OTC DRUG DYE-FREE ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20160627 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 51013-147_7df64622-c28f-49c5-910f-da515bc00f56 51013-147 HUMAN OTC DRUG NIGHTTIME COLD and FLU acetaminophen, dextromethorphan hydrobromide, doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20160713 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 51013-154_31e83e9a-e7b6-4e97-8530-ce449dc4a0f0 51013-154 HUMAN OTC DRUG Nighttime Severe Cold and Flu Relief Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide CAPSULE, LIQUID FILLED ORAL 20160727 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-155_4496f22c-670f-4f4d-9bb3-9cffde668495 51013-155 HUMAN OTC DRUG DayTime Severe Cold and Flu Relief acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20160726 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-156_873f91f1-1a5e-45f7-837d-adc9c8cd7ae2 51013-156 HUMAN OTC DRUG NiteTime Sinus Relief Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20160726 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 51013-157_edf905a2-c2eb-4c95-97da-9d9d5a2a7ba2 51013-157 HUMAN OTC DRUG DayTime Sinus acetaminophen, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20160726 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 51013-158_10369f74-60fb-4a64-8a9f-4ed336fe27de 51013-158 HUMAN OTC DRUG DAY TIME and NIGHT TIME COLD and FLU FORMULA acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride KIT 20160720 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC N 20181231 51013-159_a4c35737-da72-4aca-ae95-d7b0bd2197a1 51013-159 HUMAN OTC DRUG Daytime Sinus and Congestion acetaminophen, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20160726 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 51013-160_080271a5-b598-4be2-8bb8-f6b84ff16c4a 51013-160 HUMAN OTC DRUG Nighttime Sinus and Congestion Relief Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20160727 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 51013-161_f43d32ee-8c9c-43c9-8bcd-181d58ff0006 51013-161 HUMAN OTC DRUG Cough Relief DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20160706 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 51013-162_405707ed-f263-44c3-87c6-2712dd3297ac 51013-162 HUMAN OTC DRUG NIGHT TIME COLD and FLU FORMULA Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide CAPSULE, LIQUID FILLED ORAL 20160714 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-163_e642f9ff-f04e-424b-9b55-eb6f7c747d41 51013-163 HUMAN OTC DRUG Daytime SEVERE COLD and FLU acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20160720 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-164_08ff2d9a-0ed4-493d-8f8c-7d92fb6a1b1c 51013-164 HUMAN OTC DRUG Nighttime SEVERE COLD and FLU Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide CAPSULE, LIQUID FILLED ORAL 20160720 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-166_5cc54394-38ff-49db-bbe3-e06748224315 51013-166 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion dextromethorphan hydrobromide, guaifenesin CAPSULE, LIQUID FILLED ORAL 20160720 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 N 20181231 51013-167_0560a431-6887-4826-bcea-9d627e3a9156 51013-167 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160726 OTC MONOGRAPH FINAL part338 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 51013-168_cf2c50d5-c2e3-46e9-9b68-63a26de19071 51013-168 HUMAN OTC DRUG DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride KIT 20160615 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC N 20181231 51013-169_a2039262-9959-4098-8ad8-a35d343c9ecc 51013-169 HUMAN OTC DRUG Severe Sinus Congestion Allergy and Cough Formula Acetaminophen, Dextromethorphan hydrobromide , Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20160629 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-170_a14a36b3-8002-47af-9c18-17e4166ffdf7 51013-170 HUMAN OTC DRUG Maximum Strength Congestion and Headache ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20160610 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 51013-171_76670e91-28d7-4c60-a53d-8fd23863cab1 51013-171 HUMAN OTC DRUG Maximum Strength Night Time Cold and Flu Relief Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20160610 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-172_0c0fcfdf-daca-40f2-ad08-4f8e1f301ecd 51013-172 HUMAN OTC DRUG Extra Strength Pain Reliever ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20160608 OTC MONOGRAPH NOT FINAL part343 PuraCap Pharmaceutical LLC ACETAMINOPHEN 500 mg/1 N 20181231 51013-173_789d014a-f9c3-49c3-a352-6a43830952e5 51013-173 HUMAN OTC DRUG Regular Strength Pain Reliever ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20160623 OTC MONOGRAPH NOT FINAL part343 PuraCap Pharmaceutical LLC ACETAMINOPHEN 325 mg/1 N 20181231 51013-174_d10347cd-e5e7-4b39-afa2-1fd9b374b555 51013-174 HUMAN OTC DRUG Daytime Severe Cold and Flu Relief acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20160613 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-175_e2a3a982-ca2a-4e75-a077-9a0969d18ecb 51013-175 HUMAN OTC DRUG Night Time Severe Cold and Flu Relief Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide CAPSULE, LIQUID FILLED ORAL 20160609 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-176_60e1b20c-a0a4-90ed-e053-2a91aa0a5056 51013-176 HUMAN OTC DRUG Regular Strength Pain Relief ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20160617 20190531 OTC MONOGRAPH NOT FINAL part343 PuraCap Pharmaceutical LLC ACETAMINOPHEN 325 mg/1 N 20181231 51013-177_a5821bd5-3ff8-49e5-be1f-421440c586aa 51013-177 HUMAN OTC DRUG Maximum Strength Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20160728 OTC MONOGRAPH FINAL part332 PuraCap Pharmaceutical LLC DIMETHICONE 250 mg/1 N 20181231 51013-178_e0d9d0a6-284b-41e1-a63b-17714e1bde3e 51013-178 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion dextromethorphan hydrobromide, guaifenesin CAPSULE, LIQUID FILLED ORAL 20160727 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 N 20181231 51013-179_35f137aa-8538-433f-884f-b902b8fedfec 51013-179 HUMAN OTC DRUG MAXIMUM STRENGTH Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160712 OTC MONOGRAPH FINAL part338 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 51013-181_2f51916b-ca84-4d83-ae63-9bab547591b4 51013-181 HUMAN OTC DRUG Nighttime SLEEP AID Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160627 OTC MONOGRAPH FINAL part338 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 51013-182_6161d23e-2d54-4e48-888a-3f009bf0ac3a 51013-182 HUMAN OTC DRUG Extra Strength Pain Relief ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20160701 OTC MONOGRAPH NOT FINAL part343 PuraCap Pharmaceutical LLC ACETAMINOPHEN 500 mg/1 N 20181231 51013-183_1c5e4107-16e1-4e1c-a11a-38bbf687d9cd 51013-183 HUMAN OTC DRUG Daytime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20161012 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 51013-183_443a6f27-12c8-4138-96df-43426c2cfe34 51013-183 HUMAN OTC DRUG Daytime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20160715 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 51013-184_1035c6eb-df37-469d-9bc7-a131a1cf9da6 51013-184 HUMAN OTC DRUG Nitetime Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20161012 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 51013-184_739f62fb-ae14-478f-ba6d-3ef6d8ad5554 51013-184 HUMAN OTC DRUG Nitetime Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20160718 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 51013-185_ba3956ff-cab4-468a-af2d-03316d6aa5e9 51013-185 HUMAN OTC DRUG Day Time Sinus Relief acetaminophen, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20160714 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 51013-186_04e1b006-3b0c-4ac7-8cd2-580f70f02734 51013-186 HUMAN OTC DRUG Night Time Sinus Relief Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20160715 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 51013-187_7835a796-b650-4db5-aeca-76916351cd31 51013-187 HUMAN OTC DRUG DAY TIME Cold Flu Medicine ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20170717 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 51013-188_9d0b575b-fbc7-4d50-8d88-e282ec5c9eb3 51013-188 HUMAN OTC DRUG Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20170717 OTC MONOGRAPH FINAL part332 PuraCap Pharmaceutical LLC DIMETHICONE 125 mg/1 N 20181231 51013-189_77aa8606-819c-4c4f-9517-127720b4e1ef 51013-189 HUMAN OTC DRUG DAY TIME Cold Flu Medicine ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20161006 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 51013-191_7fa08776-ba67-4336-bc5f-c3a3d0e5a056 51013-191 HUMAN OTC DRUG COLD FLU and SORE THROAT RELIEF acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170714 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-192_b4d67981-8d99-4034-9e3a-c07b43a6a884 51013-192 HUMAN OTC DRUG Severe sinus Congestion Relief acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170714 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-193_6bf3e955-1277-410d-b819-8bb59b5189b1 51013-193 HUMAN OTC DRUG Nighttime Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170714 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-194_61ed4898-fe54-4d26-bac4-7952ee6822b8 51013-194 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170714 OTC MONOGRAPH NOT FINAL part334 PuraCap Pharmaceutical LLC DOCUSATE SODIUM 250 mg/1 N 20181231 51013-195_d19d5d86-c125-490b-a0ea-868be22690bd 51013-195 HUMAN OTC DRUG COLD FLU and SORE THROAT RELIEF acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170717 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-196_0a687262-deaa-42e4-b9b6-f3ebc67eb98b 51013-196 HUMAN OTC DRUG Daytime and Nighttime Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride KIT 20170712 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC N 20181231 51013-197_4593e2c5-f636-4ec6-9249-edc80d4e41d9 51013-197 HUMAN OTC DRUG cold, flu and sore throat acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170712 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-198_d1af93dc-9fb8-4bc9-bd1e-87e58e7a9452 51013-198 HUMAN OTC DRUG Severe sinus Congestion Relief acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170712 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-199_7114197a-6487-4a66-abdf-fe6d992c4ca9 51013-199 HUMAN OTC DRUG Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20170714 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 51013-303_c4dfc462-b30a-4868-b6bd-ec628fa5bea3 51013-303 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20160222 ANDA ANDA206855 PuraCap Pharmaceutical LLC MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 51013-304_c4dfc462-b30a-4868-b6bd-ec628fa5bea3 51013-304 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20160222 ANDA ANDA206855 PuraCap Pharmaceutical LLC MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 51013-319_127ceac7-923c-47f4-a768-47f7e46b2e97 51013-319 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20171109 ANDA ANDA079174 PuraCap Pharmaceutical LLC IBUPROFEN 200 mg/1 N 20181231 51013-320_1b2f1b11-905c-4c77-b609-ffae53749092 51013-320 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen TABLET, FILM COATED ORAL 20171109 OTC MONOGRAPH NOT FINAL part343 PuraCap Pharmaceutical LLC ACETAMINOPHEN 500 mg/1 N 20181231 51013-321_841fb60d-9e76-4a46-8905-7de3f25b6788 51013-321 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20171128 OTC MONOGRAPH FINAL part335 PuraCap Pharmaceutical LLC BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 51013-322_116d1b6a-03af-4b3c-a81a-e1a598bf4f6b 51013-322 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET, CHEWABLE ORAL 20171128 OTC MONOGRAPH FINAL part336 PuraCap Pharmaceutical LLC MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 51013-323_5f8ca325-03d7-4046-ad97-44e43e970a91 51013-323 HUMAN OTC DRUG Extra Strength Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20171213 OTC MONOGRAPH FINAL part331 PuraCap Pharmaceutical LLC CALCIUM CARBONATE 750 mg/1 N 20181231 51013-400_044f9fbe-939c-4bee-8fb8-fe9059dab1ae 51013-400 HUMAN OTC DRUG Nite Time Cold and Flu Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide CAPSULE, LIQUID FILLED ORAL 20170717 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-401_b340c41e-a648-41fb-826a-4e9f324cac1f 51013-401 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170712 OTC MONOGRAPH NOT FINAL part334 PuraCap Pharmaceutical LLC DOCUSATE SODIUM 250 mg/1 N 20181231 51013-402_27ea4713-add2-434e-ab73-3912010a79fa 51013-402 HUMAN OTC DRUG Regular Strength Pain Relief ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20170714 OTC MONOGRAPH NOT FINAL part343 PuraCap Pharmaceutical LLC ACETAMINOPHEN 325 mg/1 N 20181231 51013-405_87c1df22-3a6e-4450-a44e-fb66c08cecaa 51013-405 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170714 ANDA ANDA206568 PuraCap Pharmaceutical LLC IBUPROFEN 200 mg/1 N 20181231 51013-406_623e0e32-02d6-45ad-8d92-759c36b848b7 51013-406 HUMAN OTC DRUG Chest Congestion and Cough HBP Dextromethorphan hydrobromide, Guaifenesin CAPSULE, LIQUID FILLED ORAL 20170406 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 N 20181231 51013-407_a400e2b2-e057-4563-9e16-d85aadde13f6 51013-407 HUMAN OTC DRUG Cold and Cough Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170406 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-408_bb4434d4-6ef4-4548-8af9-0b7410b7db45 51013-408 HUMAN OTC DRUG Daytime Congestion Pressure and Pain acetaminophen, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170406 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 51013-409_bae73b3d-e38c-4a58-aaa0-f42079ce8e5a 51013-409 HUMAN OTC DRUG Mucinex Fast-Max SEVERE COLD acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170523 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-410_84f528c9-768e-4ab7-b529-7b1ffdf92a42 51013-410 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170714 ANDA ANDA206568 PuraCap Pharmaceutical LLC IBUPROFEN 200 mg/1 N 20181231 51013-415_83943274-1fe7-4cfb-8250-a914e418b7e9 51013-415 HUMAN OTC DRUG COLD FLU and SORE THROAT RELIEF acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170829 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-416_89de7ffe-fa44-491d-8c7e-a6cad748e7be 51013-416 HUMAN OTC DRUG Day Severe Cold and Night Cold and Flu Maximum Strength acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride KIT 20170829 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC N 20181231 51013-417_60ae7f21-7402-42ce-a15d-f926a2f35e92 51013-417 HUMAN OTC DRUG Severe sinus Congestion Relief acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170829 OTC MONOGRAPH FINAL part341 PuraCap Pharmaceutical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51013-419_aa441dd0-9ad7-4a09-b6b8-240724b59ead 51013-419 HUMAN OTC DRUG Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20170925 OTC MONOGRAPH FINAL part338 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 51013-420_37687272-1bf6-41ba-9c9f-c57d96e54075 51013-420 HUMAN OTC DRUG MAXIMUM STRENGTH Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20170925 OTC MONOGRAPH FINAL part338 PuraCap Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 51013-421_941cf818-cea2-4aaa-8281-06cea9c35880 51013-421 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170829 ANDA ANDA206568 PuraCap Pharmaceutical LLC IBUPROFEN 200 mg/1 N 20181231 51013-422_7754157f-4a42-411b-a119-b46e4727f213 51013-422 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20171101 ANDA ANDA206568 PuraCap Pharmaceutical LLC IBUPROFEN 200 mg/1 N 20181231 51013-423_6732619f-c0e5-44be-98eb-224eea9d9ecf 51013-423 HUMAN OTC DRUG Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20171122 OTC MONOGRAPH FINAL part332 PuraCap Pharmaceutical LLC DIMETHICONE 125 mg/1 N 20181231 51013-424_8fe6ff6c-015b-4dd2-973d-d4f622b5f34f 51013-424 HUMAN OTC DRUG Maximum Strength Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20171122 OTC MONOGRAPH FINAL part332 PuraCap Pharmaceutical LLC DIMETHICONE 250 mg/1 N 20181231 51013-801_60147d64-71a1-8609-e053-2a91aa0aa323 51013-801 HUMAN OTC DRUG Eptex 4.5% Benzoyl Peroxide LIQUID, EXTENDED RELEASE TOPICAL 20161023 OTC MONOGRAPH FINAL part333D PuraCap Pharmaceutical LLC BENZOYL PEROXIDE 4.5 mg/100mL N 20181231 51013-802_6014cea6-0d0c-14c2-e053-2a91aa0a9666 51013-802 HUMAN OTC DRUG Eptex 2% Salicylic Acid LIQUID, EXTENDED RELEASE TOPICAL 20161023 OTC MONOGRAPH FINAL part333D PuraCap Pharmaceutical LLC SALICYLIC ACID 2 mg/100mL N 20181231 51021-150_aea024cf-de2b-4582-9bd6-f2b3de945099 51021-150 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20150708 ANDA ANDA202769 Sircle Laboratories, LLC DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 51021-250_3d3cc581-a8be-4bf1-b360-42d01d586783 51021-250 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION/ DROPS TRANSDERMAL 20150820 ANDA ANDA204132 Sircle Laboratories, LLC DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51021-278_ae2b3302-6ee4-4cc3-ac5d-83b831e306e8 51021-278 HUMAN PRESCRIPTION DRUG Vopac MDS - Anti-Inflammatory Management Kit with Metered Dose Bottle Diclofenac Sodium and Isopropyl Alcohol KIT 20160401 ANDA ANDA203399 Sircle Laboratories, LLC N 20181231 51021-333_3c99f58a-3185-4557-be23-0a1cdf0ce18c 51021-333 HUMAN PRESCRIPTION DRUG Metaxall Metaxalone TABLET ORAL 20150925 ANDA ANDA203399 Sircle Laboratories, LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20191231 51021-372_073f47e3-0e56-48c3-85af-baba7a4826dc 51021-372 HUMAN PRESCRIPTION DRUG Diclofex DC Diclofenac Sodium and Capsaicin KIT 20160430 ANDA ANDA204132 Sircle Laboratories, LLC N 20181231 51021-374_981c3b98-87ce-4d6b-aa2b-474cf63392d6 51021-374 HUMAN PRESCRIPTION DRUG Diclofex DC Diclofenac Sodium and Capsaicin KIT 20160430 ANDA ANDA204132 Sircle Laboratories, LLC N 20181231 51021-375_5df75e8b-0204-105c-e053-2a91aa0a79d7 51021-375 HUMAN PRESCRIPTION DRUG Priloxx LP External Kit lidocaine and prilocaine cream KIT TOPICAL 20170520 ANDA ANDA019941 Sircle Laboratories LLC N 20181231 51021-440_baa2b544-9a16-45be-8eab-3535fced5545 51021-440 HUMAN PRESCRIPTION DRUG Professional Medicated DNA Collection Lidocaine Hydrochloride and Glycerin KIT 19950710 ANDA ANDA040014 Sircle Laboratories, LLC N 20181231 51027-0007_e65c7473-b35e-44b4-a4e1-7cbc0b18205a 51027-0007 HUMAN OTC DRUG KINKAN ammonia, camphor (natural), menthol LINIMENT TOPICAL 20000426 OTC MONOGRAPH NOT FINAL part348 KINKANDO CO., LTD. AMMONIA; CAMPHOR (NATURAL); MENTHOL 1.1; 1.55; 3 g/50mL; g/50mL; g/50mL N 20181231 51027-0330_15e0a87b-6ffd-4529-bffa-0f5ad4e4a16d 51027-0330 HUMAN OTC DRUG KINKAN COOL diphenhydramine hydrochloride, menthol LINIMENT TOPICAL 20000426 OTC MONOGRAPH NOT FINAL part348 KINKANDO CO., LTD. DIPHENHYDRAMINE HYDROCHLORIDE; MENTHOL 1; .5 g/50mL; g/50mL N 20181231 51028-002_60acb695-4f27-57d6-e053-2a91aa0a19a2 51028-002 HUMAN OTC DRUG Chamosyn Barrier Cream OINTMENT TOPICAL 20150115 OTC MONOGRAPH FINAL part346 Links Medical Products MENTHOL; ZINC OXIDE 1; 200 mg/g; mg/g N 20191231 51028-003_60acb695-4f27-57d6-e053-2a91aa0a19a2 51028-003 HUMAN OTC DRUG Chamosyn Paraben Free Barrier Cream OINTMENT TOPICAL 20160101 OTC MONOGRAPH FINAL part346 Links Medical Products MENTHOL; ZINC OXIDE 4.5; 200 mg/g; mg/g N 20191231 51042-050_58df0085-2488-4ca0-b4d2-0c690905eaae 51042-050 HUMAN OTC DRUG First Mark Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20100625 OTC MONOGRAPH NOT FINAL part333A Performance Food Group TRICLOSAN .3 mL/100mL E 20171231 51042-689_0686590d-4c92-4b7b-9d6d-1a4c0e16cf2a 51042-689 HUMAN OTC DRUG First Mark Foam Antimicrobial Hand Cleaner Triclosan LIQUID TOPICAL 20100624 OTC MONOGRAPH NOT FINAL part333 Performance Food Group TRICLOSAN .5 mL/100mL E 20171231 51042-692_9316646c-2f55-413d-988f-def3492502f5 51042-692 HUMAN OTC DRUG First Mark Foaming Hand Cleaner Benzethonium Chloride LIQUID TOPICAL 20100623 OTC MONOGRAPH NOT FINAL part333 Performance Food Group BENZETHONIUM CHLORIDE .2 mL/100mL E 20171231 51048-005_721f921b-cef8-4645-88a7-7babf716403f 51048-005 HUMAN OTC DRUG DOP Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL LIQUID TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333A Omega & Delta Co., Inc. ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 51048-040_573e5c7e-6d7c-4ee5-9f2d-ccea5715180c 51048-040 HUMAN OTC DRUG DOP Hydrogen Peroxide 3% Hydrogen Peroxide LIQUID TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333A Omega & Delta Co. Inc. HYDROGEN PEROXIDE 3 g/100mL E 20171231 51051-001_f0473782-3ef9-4bac-9ed8-022907aa5f2b 51051-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100701 UNAPPROVED MEDICAL GAS Pure Process Medical & Scientific Gases, LLC OXYGEN 990 mL/L E 20171231 51051-002_8d003d87-ad05-4ca0-965d-45fc75021b01 51051-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20160215 NDA NDA205766 Atlas Welding Supply Company, Inc. NITROGEN 990 mL/L N 20181231 51051-003_3b7b2f87-ba6b-4bee-92d9-a51c7ea5bdea 51051-003 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20160215 NDA NDA205767 Atlas Welding Supply Company, Inc. OXYGEN 990 mL/L N 20181231 51053-500_7b3f45f7-3757-49d2-8976-a33282db8c4f 51053-500 HUMAN OTC DRUG Alcohol free hand sanitizer BENZALKONIUM CHLORIDE AEROSOL, FOAM TOPICAL 20100524 OTC MONOGRAPH NOT FINAL part352 Sanihealth Products Corporation BENZALKONIUM CHLORIDE 1.2 mL/1000mL E 20171231 51053-501_7811f85c-d9e6-4ca3-81d7-64773f71f314 51053-501 HUMAN OTC DRUG Antibacterial Foam Chloroxylenol SOAP TOPICAL 20100518 UNAPPROVED DRUG OTHER Sanihealth Products Corporation CHLOROXYLENOL 5 mL/1000mL E 20171231 51053-502_3231512f-c1f6-4f9f-ba51-77f54c416683 51053-502 HUMAN OTC DRUG Antibacterial Soap chloroxylenol GEL TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 Sanihealth Products Corporation CHLOROXYLENOL 4 mL/800mL E 20171231 51060-001_87e4e518-724d-4037-8e22-4989066e98b5 51060-001 HUMAN OTC DRUG ReCreate Foundation Porcelain Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL E 20171231 51060-002_87e4e518-724d-4037-8e22-4989066e98b5 51060-002 HUMAN OTC DRUG ReCreate Foundation Ivory Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL E 20171231 51060-003_87e4e518-724d-4037-8e22-4989066e98b5 51060-003 HUMAN OTC DRUG ReCreate Foundation Cool Bisque Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL E 20171231 51060-004_87e4e518-724d-4037-8e22-4989066e98b5 51060-004 HUMAN OTC DRUG ReCreate Foundation Warm Bisque Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL E 20171231 51060-005_87e4e518-724d-4037-8e22-4989066e98b5 51060-005 HUMAN OTC DRUG ReCreate Foundation Beige Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL E 20171231 51060-006_87e4e518-724d-4037-8e22-4989066e98b5 51060-006 HUMAN OTC DRUG ReCreate Foundation Cool Sand Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL E 20171231 51060-007_87e4e518-724d-4037-8e22-4989066e98b5 51060-007 HUMAN OTC DRUG ReCreate Foundation Warm Sand Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL E 20171231 51060-008_87e4e518-724d-4037-8e22-4989066e98b5 51060-008 HUMAN OTC DRUG ReCreate Foundation Natural Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL E 20171231 51060-009_87e4e518-724d-4037-8e22-4989066e98b5 51060-009 HUMAN OTC DRUG ReCreate Foundation Honey Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL E 20171231 51060-010_87e4e518-724d-4037-8e22-4989066e98b5 51060-010 HUMAN OTC DRUG ReCreate Foundation Warm Walnut Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL E 20171231 51060-011_87e4e518-724d-4037-8e22-4989066e98b5 51060-011 HUMAN OTC DRUG ReCreate Foundation Walnut Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL E 20171231 51060-012_87e4e518-724d-4037-8e22-4989066e98b5 51060-012 HUMAN OTC DRUG ReCreate Foundation Chestnut Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 Tarte Inc OCTINOXATE; OCTISALATE; OXYBENZONE 2.2125; 1.18; .59 mL/29.5mL; mL/29.5mL; mL/29.5mL E 20171231 51060-015_cf7b4e6b-6409-4df8-8f75-26f1e207cfe1 51060-015 HUMAN OTC DRUG TARTEGUARD 30 sunscreen Broad Spectrum SPF 30 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20150401 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 33.6; 41.3 mg/mL; mg/mL E 20171231 51060-017_ea095aa8-60aa-43ea-a621-63d4ab810173 51060-017 HUMAN OTC DRUG Amazonian clay BB illuminating moisturizer Broad Spectrum SPF 15 Sunscreen Octinoxate, Oxybenzone, and Titanium Dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 75; 30; 50 mg/mL; mg/mL; mg/mL N 20181231 51060-018_c101e35b-ba30-4654-8cc5-44a121222800 51060-018 HUMAN OTC DRUG BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen Fair Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 45.5; 35 mg/mL; mg/mL E 20171231 51060-019_c101e35b-ba30-4654-8cc5-44a121222800 51060-019 HUMAN OTC DRUG BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen Light Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 45.5; 35 mg/mL; mg/mL E 20171231 51060-020_c101e35b-ba30-4654-8cc5-44a121222800 51060-020 HUMAN OTC DRUG BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 45.5; 35 mg/mL; mg/mL E 20171231 51060-021_c101e35b-ba30-4654-8cc5-44a121222800 51060-021 HUMAN OTC DRUG BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen Medium-Tan Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 45.5; 35 mg/mL; mg/mL E 20171231 51060-022_c101e35b-ba30-4654-8cc5-44a121222800 51060-022 HUMAN OTC DRUG BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen Tan Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 45.5; 35 mg/mL; mg/mL E 20171231 51060-023_c101e35b-ba30-4654-8cc5-44a121222800 51060-023 HUMAN OTC DRUG BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen Tan Deep Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 45.5; 35 mg/mL; mg/mL E 20171231 51060-024_f4253ee1-05c9-4398-b9f7-0531559fd9c2 51060-024 HUMAN OTC DRUG Beyond BB Perfecting Foundation Broad Spectrum SPF 15 Sunscreen Fair Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-025_f4253ee1-05c9-4398-b9f7-0531559fd9c2 51060-025 HUMAN OTC DRUG Beyond BB Perfecting Foundation Broad Spectrum SPF 15 Sunscreen Light Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-026_f4253ee1-05c9-4398-b9f7-0531559fd9c2 51060-026 HUMAN OTC DRUG Beyond BB Perfecting Foundation Broad Spectrum SPF 15 Sunscreen Medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-027_f4253ee1-05c9-4398-b9f7-0531559fd9c2 51060-027 HUMAN OTC DRUG Beyond BB Perfecting Foundation Broad Spectrum SPF 15 Sunscreen Tan Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-028_f4253ee1-05c9-4398-b9f7-0531559fd9c2 51060-028 HUMAN OTC DRUG Beyond BB Perfecting Foundation Broad Spectrum SPF 15 Sunscreen Deep Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-029_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-029 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Ivory Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 51060-030_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-030 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Fair Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 51060-031_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-031 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Beige Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 51060-032_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-032 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Light Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 51060-033_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-033 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Warm Beige Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 51060-034_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-034 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Light-Medium Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 51060-035_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-035 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Medium Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 51060-036_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-036 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Medium-Tan Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 51060-037_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-037 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Tan Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 51060-038_1992e5c0-7e7d-4b78-8509-12b146b7f9c5 51060-038 HUMAN OTC DRUG Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Deep Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 51060-039_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-039 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Fair Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 51060-040_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-040 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 51060-041_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-041 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Light Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 51060-042_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-042 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Light-Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 51060-043_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-043 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 51060-044_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-044 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Medium-Tan Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 51060-045_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-045 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Tan Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 51060-046_7af83dff-cee0-42b2-9520-9c3e2a04623c 51060-046 HUMAN OTC DRUG Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Tan-Deep Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 51060-047_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-047 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Deep Sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-048_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-048 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Fair Beige Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-049_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-049 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Fair Sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-050_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-050 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Fair- Light Honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-051_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-051 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Ivory Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-052_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-052 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Light Beige Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-053_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-053 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Light Neutral Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-054_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-054 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Light Sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-055_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-055 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Light-Medium Beige Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-056_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-056 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Light-Medium Honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-057_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-057 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Light-Medium Sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-058_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-058 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Medium Honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-059_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-059 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Medium Sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-060_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-060 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Medium-Tan Honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-061_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-061 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Tan Honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-062_bf7f7425-9d1d-49ec-9a73-cccb461e7d28 51060-062 HUMAN OTC DRUG Amazonian Clay 12-Hour Full Coverage Foundation Broad Spectrum SPF 15 Sunscreen Tan-Deep Sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-063_716da22b-0f3a-4ff3-8a11-3f8c44d08aa6 51060-063 HUMAN OTC DRUG Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Fair Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL E 20171231 51060-064_716da22b-0f3a-4ff3-8a11-3f8c44d08aa6 51060-064 HUMAN OTC DRUG Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Light Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL E 20171231 51060-065_716da22b-0f3a-4ff3-8a11-3f8c44d08aa6 51060-065 HUMAN OTC DRUG Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL E 20171231 51060-066_716da22b-0f3a-4ff3-8a11-3f8c44d08aa6 51060-066 HUMAN OTC DRUG Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Tan Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL E 20171231 51060-067_716da22b-0f3a-4ff3-8a11-3f8c44d08aa6 51060-067 HUMAN OTC DRUG Amazonian Colored Clay Foundation Broad Spectrum SPF 15 Sunscreen Deep Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL E 20171231 51060-068_7c6b6360-e61a-4a83-aad0-58e47f178ed8 51060-068 HUMAN OTC DRUG foundcealer 2-in-1 foundation and concealer Broad Spectrum SPF 15 Sunscreen fair Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-069_7c6b6360-e61a-4a83-aad0-58e47f178ed8 51060-069 HUMAN OTC DRUG foundcealer 2-in-1 foundation and concealer Broad Spectrum SPF 15 Sunscreen light Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-070_7c6b6360-e61a-4a83-aad0-58e47f178ed8 51060-070 HUMAN OTC DRUG foundcealer 2-in-1 foundation and concealer Broad Spectrum SPF 15 Sunscreen light-medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-071_7c6b6360-e61a-4a83-aad0-58e47f178ed8 51060-071 HUMAN OTC DRUG foundcealer 2-in-1 foundation and concealer Broad Spectrum SPF 15 Sunscreen medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-072_7c6b6360-e61a-4a83-aad0-58e47f178ed8 51060-072 HUMAN OTC DRUG foundcealer 2-in-1 foundation and concealer Broad Spectrum SPF 15 Sunscreen tan Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-073_7c6b6360-e61a-4a83-aad0-58e47f178ed8 51060-073 HUMAN OTC DRUG foundcealer 2-in-1 foundation and concealer Broad Spectrum SPF 15 Sunscreen deep Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51060-081_e28a5bfa-ba01-448d-9607-943603d04302 51060-081 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen fair Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL E 20171231 51060-082_e28a5bfa-ba01-448d-9607-943603d04302 51060-082 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen light Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL E 20171231 51060-083_e28a5bfa-ba01-448d-9607-943603d04302 51060-083 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen light-medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL E 20171231 51060-084_e28a5bfa-ba01-448d-9607-943603d04302 51060-084 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL E 20171231 51060-085_e28a5bfa-ba01-448d-9607-943603d04302 51060-085 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen tan Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL E 20171231 51060-086_e28a5bfa-ba01-448d-9607-943603d04302 51060-086 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen deep Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 40 mg/mL; mg/mL E 20171231 51060-087_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-087 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen fair neutral Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-088_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-088 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen fair-light neutral Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-089_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-089 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen light neutral Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-090_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-090 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen light sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-091_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-091 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen light-medium beige Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-092_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-092 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen light-medium honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-093_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-093 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen light-medium neutral Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-094_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-094 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen medium honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-095_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-095 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen medium neutral Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-096_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-096 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen medium-tan sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-097_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-097 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen tan sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-098_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-098 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen deep honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-099_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-099 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen fair Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-100_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-100 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen light Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-101_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-101 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen light-medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-102_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-102 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-103_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-103 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen tan Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-104_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-104 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen deep Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-105_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-105 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen porcelain Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20161206 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-106_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-106 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen fair beige Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20161206 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-107_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-107 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen fair-light sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20161206 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-108_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-108 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen light honey Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20161206 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-109_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-109 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen light-medium sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20161206 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-110_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-110 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen medium sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20161206 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-111_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-111 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen deep sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20161206 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-112_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-112 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen rich sand Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20161206 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-113_a60429ef-cbcc-4121-a73b-d004afdc6ebd 51060-113 HUMAN OTC DRUG Rainforest of the Sea Water Foundation Broad Spectrum SPF 15 Sunscreen mahogany Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20161206 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 62.3; 38.4 mg/mL; mg/mL E 20171231 51060-114_717b39ba-f56e-48b5-8b11-903bdd45979f 51060-114 HUMAN OTC DRUG Tarteguard 20 Tinted Moisturizer light Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20170401 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 51060-115_717b39ba-f56e-48b5-8b11-903bdd45979f 51060-115 HUMAN OTC DRUG Tarteguard 20 Tinted Moisturizer light-medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20170401 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 51060-116_717b39ba-f56e-48b5-8b11-903bdd45979f 51060-116 HUMAN OTC DRUG Tarteguard 20 Tinted Moisturizer medium Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20170401 OTC MONOGRAPH FINAL part352 Tarte, Inc TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 51068-501_6a97a677-5c25-4d3a-9593-3191f6a981bd 51068-501 HUMAN OTC DRUG ActivOn Ultra Strength Arthritis Menthol and Histamine Dihydrochloride STICK TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 Family First Pharmaceuticals, Inc. MENTHOL, UNSPECIFIED FORM; HISTAMINE DIHYDROCHLORIDE .04574; .00028 g/g; g/g E 20171231 51068-503_2ab5e94f-2b75-48bc-98d5-81e71f64227b 51068-503 HUMAN OTC DRUG ActivOn Ultra Strength Joint and Muscle Menthol STICK TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 Family First Pharmaceuticals, Inc. MENTHOL .05138 g/g E 20171231 51068-507_315fd1be-ae83-460e-96ac-e8117ded1dd7 51068-507 HUMAN OTC DRUG ActivOn Ultra Strength Arthritis Menthol, Unspecified Form STICK TOPICAL 20170215 OTC MONOGRAPH NOT FINAL part348 Family First Pharmaceuticals, Inc. MENTHOL, UNSPECIFIED FORM .05138 g/g N 20181231 51069-0001_fe84aac7-73c6-423a-bb56-e8229192a1ee 51069-0001 HUMAN OTC DRUG Metabolic Support Asclepias vincetoxicum, Echinacea, Hypothalamus (suis), Brain (suis), Hepar suis, Methylcobalamin, Pancreas suis, Renal (suis), Stomach (suis), AACG-A, LIQUID ORAL 20120906 UNAPPROVED HOMEOPATHIC Seriously Slim CYNANCHUM VINCETOXICUM ROOT; ECHINACEA, UNSPECIFIED; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; METHYLCOBALAMIN; SUS SCROFA PANCREAS; PORK KIDNEY; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-OXO-PRASTERONE; ADENOSINE TRIPHOSPHATE; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS INCONSTANS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 51072-088_aab41098-f0ac-4b6f-8366-e8b6bef28b66 51072-088 HUMAN OTC DRUG Pyrantel Pamoate Pyrantel Pamoate SUSPENSION ORAL 20151121 OTC MONOGRAPH FINAL part357B Jefferson Labs PYRANTEL PAMOATE 50 mg/mL N 20191231 51073-801_7d0fd474-61ea-40c3-bf22-d17e903c29ff 51073-801 HUMAN OTC DRUG Health and Beyond Antiseptic Hand Sanitizer ETHYL ALCOHOL SPRAY TOPICAL 20110609 OTC MONOGRAPH NOT FINAL part333E Suzhou Health and Beyond Hygienic Products Inc. ALCOHOL 62 mL/100mL E 20171231 51079-007_5b33513c-4118-6736-e053-2a91aa0a1c53 51079-007 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20030901 ANDA ANDA075876 Mylan Institutional Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 51079-020_5da846b3-4080-7d39-e053-2a91aa0a2f18 51079-020 HUMAN PRESCRIPTION DRUG Budesonide budesonide CAPSULE ORAL 20110902 ANDA ANDA090410 Mylan Institutional Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51079-023_c42a0e21-15b8-4cbe-8625-6a8f5fd0c226 51079-023 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20050415 ANDA ANDA076698 Mylan Institutional Inc. METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 51079-024_c42a0e21-15b8-4cbe-8625-6a8f5fd0c226 51079-024 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20050201 ANDA ANDA076698 Mylan Institutional Inc. METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 51079-028_478ffcf5-42c6-4275-8571-e8ade81fa7a5 51079-028 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20101101 ANDA ANDA090596 Mylan Institutional Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 51079-047_3b73fe46-ac1a-657c-e054-00144ff88e88 51079-047 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110323 ANDA ANDA090942 Mylan Institutional Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 51079-051_50eda997-68dc-70a6-e054-00144ff88e88 51079-051 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20110223 ANDA ANDA090970 Mylan Institutional Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 51079-058_e07c7c15-b950-4817-bc82-1a65798b2404 51079-058 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 20130503 ANDA ANDA086831 Mylan Institutional Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 51079-062_5bed7cb1-1e65-202e-e053-2a91aa0a9886 51079-062 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20131121 ANDA ANDA090252 Mylan Institutional Inc. REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 51079-072_5de62de5-734a-3bb9-e053-2991aa0acd32 51079-072 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19951001 NDA NDA018487 Mylan Institutional Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 51079-073_5de62de5-734a-3bb9-e053-2991aa0acd32 51079-073 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19951001 NDA NDA018487 Mylan Institutional Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 51079-074_4ceb969f-411d-04b8-e054-00144ff8d46c 51079-074 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20071226 ANDA ANDA089097 Mylan Institutional Inc. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 51079-075_4ceb969f-411d-04b8-e054-00144ff8d46c 51079-075 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20071226 ANDA ANDA088467 Mylan Institutional Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 51079-076_4ceb969f-411d-04b8-e054-00144ff8d46c 51079-076 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20071226 ANDA ANDA088468 Mylan Institutional Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 51079-077_52012fe8-4a14-6e7d-e054-00144ff8d46c 51079-077 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20071126 ANDA ANDA088496 Mylan Institutional Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 51079-078_52012fe8-4a14-6e7d-e054-00144ff8d46c 51079-078 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20071126 ANDA ANDA088487 Mylan Institutional Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 51079-083_4651bdf7-9c0f-5acf-e054-00144ff88e88 51079-083 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19940609 ANDA ANDA080937 Mylan Institutional Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 51079-086_5de580dc-6390-3641-e053-2a91aa0ac4d4 51079-086 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030801 ANDA ANDA076122 Mylan Institutional Inc. MIRTAZAPINE 15 mg/1 N 20181231 51079-087_5de580dc-6390-3641-e053-2a91aa0ac4d4 51079-087 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030801 ANDA ANDA076122 Mylan Institutional Inc. MIRTAZAPINE 30 mg/1 N 20181231 51079-088_5de580dc-6390-3641-e053-2a91aa0ac4d4 51079-088 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030801 ANDA ANDA076122 Mylan Institutional Inc. MIRTAZAPINE 45 mg/1 N 20181231 51079-093_eaf7b0b1-5a7d-4f81-b645-9e8b82356cbb 51079-093 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20110307 ANDA ANDA078518 Mylan Institutional Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 51079-103_5bee42f5-e1c4-577e-e053-2a91aa0aa6e0 51079-103 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19960201 ANDA ANDA040424 Mylan Institutional Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 51079-104_5bed9894-93fd-3e64-e053-2a91aa0a301b 51079-104 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide spironolactone and hydrochlorothiazide TABLET ORAL 19940411 20181130 ANDA ANDA086513 Mylan Institutional Inc. SPIRONOLACTONE; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51079-105_d7bc46a5-ac1e-47f2-88f3-3351fdbbdbf4 51079-105 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20110421 ANDA ANDA040756 Mylan Institutional Inc. FOLIC ACID 1 mg/1 N 20181231 51079-107_465169b9-d554-4d9c-e054-00144ff88e88 51079-107 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19940215 ANDA ANDA086009 Mylan Institutional Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51079-109_3b73fe46-ac1a-657c-e054-00144ff88e88 51079-109 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110718 ANDA ANDA090942 Mylan Institutional Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 51079-118_4143e4b4-3a1e-7117-e054-00144ff8d46c 51079-118 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride CAPSULE ORAL 19991201 ANDA ANDA040319 Mylan Institutional Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 51079-119_4143e4b4-3a1e-7117-e054-00144ff8d46c 51079-119 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 19980306 ANDA ANDA040317 Mylan Institutional Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 51079-121_5da846b3-40c9-7d39-e053-2a91aa0a2f18 51079-121 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20091201 ANDA ANDA090763 Mylan Institutional Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 51079-129_ff98f6b8-554a-43b6-b4d5-d7c6bed8fbbb 51079-129 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin TABLET, CHEWABLE ORAL 20121218 ANDA ANDA200691 Mylan Institutional Inc. PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 51079-130_5bed9894-9431-3e64-e053-2a91aa0a301b 51079-130 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19941123 ANDA ANDA084113 Mylan Institutional Inc. CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-131_465169b9-d554-4d9c-e054-00144ff88e88 51079-131 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19940216 ANDA ANDA086009 Mylan Institutional Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51079-133_465169b9-d554-4d9c-e054-00144ff88e88 51079-133 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19941026 ANDA ANDA086009 Mylan Institutional Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51079-141_604f966c-359e-a6ab-e053-2991aa0a8890 51079-141 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19940506 ANDA ANDA084769 Mylan Institutional Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-142_5b33322a-d251-0bdc-e053-2a91aa0aeaec 51079-142 HUMAN PRESCRIPTION DRUG Lithium Carbonate lithium carbonate TABLET, EXTENDED RELEASE ORAL 20120420 ANDA ANDA202219 Mylan Institutional Inc. LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] N 20181231 51079-145_31e2d4e4-2d0f-08af-e054-00144ff88e88 51079-145 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040521 ANDA ANDA076430 Mylan Institutional Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51079-146_31e2d4e4-2d0f-08af-e054-00144ff88e88 51079-146 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040521 ANDA ANDA076430 Mylan Institutional Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51079-147_465169b9-d554-4d9c-e054-00144ff88e88 51079-147 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19940216 ANDA ANDA086009 Mylan Institutional Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51079-161_5cc511e4-3e36-70d6-e053-2a91aa0a8044 51079-161 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19961223 ANDA ANDA088628 Mylan Institutional Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 51079-164_466078d0-f4c1-2c07-e054-00144ff8d46c 51079-164 HUMAN PRESCRIPTION DRUG Voriconazole voriconazole TABLET, FILM COATED ORAL 20110510 ANDA ANDA090547 Mylan Institutional Inc. VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 51079-165_466078d0-f4c1-2c07-e054-00144ff8d46c 51079-165 HUMAN PRESCRIPTION DRUG Voriconazole voriconazole TABLET, FILM COATED ORAL 20110510 ANDA ANDA090547 Mylan Institutional Inc. VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 51079-169_4ecc4a25-adf3-28cf-e054-00144ff8d46c 51079-169 HUMAN PRESCRIPTION DRUG Metoprolol Succinate metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120127 ANDA ANDA202033 Mylan Institutional Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-170_4ecc4a25-adf3-28cf-e054-00144ff8d46c 51079-170 HUMAN PRESCRIPTION DRUG Metoprolol Succinate metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120127 ANDA ANDA202033 Mylan Institutional Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-171_4ecc4a25-adf3-28cf-e054-00144ff8d46c 51079-171 HUMAN PRESCRIPTION DRUG Metoprolol Succinate metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120127 ANDA ANDA202033 Mylan Institutional Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-172_46012f43-8eb2-3ef0-e054-00144ff88e88 51079-172 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA075973 Mylan Institutional Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51079-174_46012f43-8eb2-3ef0-e054-00144ff88e88 51079-174 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20121005 ANDA ANDA075973 Mylan Institutional Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51079-180_5bed9460-0202-127c-e053-2991aa0a8ae0 51079-180 HUMAN PRESCRIPTION DRUG Lithium Carbonate lithium carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120810 ANDA ANDA202288 Mylan Institutional Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 51079-182_5e0aa030-2589-0c3d-e053-2a91aa0aa060 51079-182 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20110411 ANDA ANDA075817 Mylan Institutional Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 51079-190_5de0dff6-1da9-3deb-e053-2991aa0a5ec4 51079-190 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 19980910 NDA NDA018858 Mylan Institutional Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51079-191_5de0dff6-1da9-3deb-e053-2991aa0a5ec4 51079-191 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 19980915 ANDA ANDA070624 Mylan Institutional Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51079-197_205b572b-dc91-48db-829e-179bade6b0ea 51079-197 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20140128 ANDA ANDA201486 Mylan Institutional Inc. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 51079-198_205b572b-dc91-48db-829e-179bade6b0ea 51079-198 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20140129 ANDA ANDA201486 Mylan Institutional Inc. TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 51079-199_50ed6458-1e55-6a74-e054-00144ff88e88 51079-199 HUMAN PRESCRIPTION DRUG Celecoxib celecoxib CAPSULE ORAL 20150224 ANDA ANDA078857 Mylan Institutional Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51079-200_3b73fe46-ac87-657c-e054-00144ff88e88 51079-200 HUMAN PRESCRIPTION DRUG Methyldopa methyldopa TABLET ORAL 19980901 ANDA ANDA070076 Mylan Institutional Inc. METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 51079-201_3b73fe46-ac87-657c-e054-00144ff88e88 51079-201 HUMAN PRESCRIPTION DRUG Methyldopa methyldopa TABLET ORAL 19980901 ANDA ANDA070076 Mylan Institutional Inc. METHYLDOPA 500 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 51079-204_3aea9a4b-1abf-3edd-e054-00144ff8d46c 51079-204 HUMAN PRESCRIPTION DRUG Abacavir Sulfate abacavir sulfate TABLET, FILM COATED ORAL 20120801 ANDA ANDA091294 Mylan Institutional Inc. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 51079-205_31e2c84d-76f5-4582-e054-00144ff8d46c 51079-205 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 19970429 ANDA ANDA018659 Mylan Institutional Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 51079-206_31e2c84d-76f5-4582-e054-00144ff8d46c 51079-206 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 19970429 ANDA ANDA018659 Mylan Institutional Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 51079-208_31e2497f-1f2f-0e26-e054-00144ff88e88 51079-208 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20140130 ANDA ANDA091226 Mylan Institutional Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51079-209_31e2497f-1f2f-0e26-e054-00144ff88e88 51079-209 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20140129 ANDA ANDA091226 Mylan Institutional Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51079-210_31e2497f-1f2f-0e26-e054-00144ff88e88 51079-210 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20140129 ANDA ANDA091226 Mylan Institutional Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51079-211_31e2497f-1f2f-0e26-e054-00144ff88e88 51079-211 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20140123 ANDA ANDA091226 Mylan Institutional Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51079-212_4be46ab2-773d-4039-e054-00144ff8d46c 51079-212 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET, ORALLY DISINTEGRATING ORAL 20170323 ANDA ANDA201824 Mylan Institutional Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-215_50ed6458-1e55-6a74-e054-00144ff88e88 51079-215 HUMAN PRESCRIPTION DRUG Celecoxib celecoxib CAPSULE ORAL 20150224 ANDA ANDA078857 Mylan Institutional Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51079-216_4cd5f546-c6f6-20f4-e054-00144ff88e88 51079-216 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20120820 ANDA ANDA070035 Mylan Institutional Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 51079-223_52012fe8-49bd-6e7d-e054-00144ff8d46c 51079-223 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, FILM COATED ORAL 20120828 ANDA ANDA079103 Mylan Institutional Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 51079-224_5e0aabe6-0929-4386-e053-2991aa0ac495 51079-224 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 20100604 ANDA ANDA075281 Mylan Institutional Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51079-235_f504a321-0cf9-4b10-9f8c-8167889785d9 51079-235 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate tolterodine TABLET, FILM COATED ORAL 20130326 ANDA ANDA202641 Mylan Institutional Inc. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 51079-241_3bffa240-ca41-3bf6-e054-00144ff88e88 51079-241 HUMAN PRESCRIPTION DRUG Acamprosate Calcium acamprosate calcium enteric-coated TABLET, DELAYED RELEASE ORAL 20130716 ANDA ANDA200142 Mylan Institutional Inc. ACAMPROSATE CALCIUM 333 mg/1 N 20181231 51079-246_438bf5e2-20fc-04f5-e054-00144ff88e88 51079-246 HUMAN OTC DRUG Loratadine loratadine TABLET ORAL 20130430 ANDA ANDA076154 Mylan Institutional Inc. LORATADINE 10 mg/1 N 20181231 51079-247_50d929e5-2eea-5c10-e054-00144ff88e88 51079-247 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 20121228 ANDA ANDA071293 Mylan Institutional Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 51079-255_4fe11562-6f67-4eb2-e054-00144ff88e88 51079-255 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20040920 ANDA ANDA076704 Mylan Institutional Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-273_438ecccc-7a92-04a4-e054-00144ff8d46c 51079-273 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20131212 NDA AUTHORIZED GENERIC NDA020796 Mylan Institutional Inc. ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 51079-284_415b2626-85ab-0fd4-e054-00144ff88e88 51079-284 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 19971031 ANDA ANDA070325 Mylan Institutional Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-285_415b2626-85ab-0fd4-e054-00144ff88e88 51079-285 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 19971104 ANDA ANDA070325 Mylan Institutional Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-286_415b2626-85ab-0fd4-e054-00144ff88e88 51079-286 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 19971031 ANDA ANDA070325 Mylan Institutional Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-288_4be46ab2-773d-4039-e054-00144ff8d46c 51079-288 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET, ORALLY DISINTEGRATING ORAL 20160926 ANDA ANDA201824 Mylan Institutional Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-294_5bed416f-05ce-1e9a-e053-2991aa0a5d5f 51079-294 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100507 ANDA ANDA090408 Mylan Institutional Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51079-299_5de0d4c8-a029-3844-e053-2991aa0ab17c 51079-299 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 19970214 ANDA ANDA070317 Mylan Institutional Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 51079-300_5de0d4c8-a029-3844-e053-2991aa0ab17c 51079-300 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 19950612 ANDA ANDA070317 Mylan Institutional Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 51079-301_5de0d4c8-a029-3844-e053-2991aa0ab17c 51079-301 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 19950612 ANDA ANDA070317 Mylan Institutional Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 51079-306_f0437ae6-e4f0-49dc-ad06-301da07c8118 51079-306 HUMAN OTC DRUG Polyethylene Glycol (3350) polyethylene glycol (3350) POWDER, FOR SOLUTION ORAL 20091120 ANDA ANDA078915 Mylan Institutional Inc. POLYETHYLENE GLYCOL 3500 17 g/17g N 20181231 51079-321_5d6e4c8f-dcd0-72ea-e053-2991aa0aa71f 51079-321 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20150713 ANDA ANDA077578 Mylan Institutional Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 51079-345_f8ad5442-e45b-4843-b749-bc1af5fdd39c 51079-345 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20110610 ANDA ANDA091537 Mylan Institutional Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-346_f8ad5442-e45b-4843-b749-bc1af5fdd39c 51079-346 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20110610 ANDA ANDA091537 Mylan Institutional Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-347_f8ad5442-e45b-4843-b749-bc1af5fdd39c 51079-347 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20110610 ANDA ANDA091537 Mylan Institutional Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-348_4ce6ee77-abee-5ce7-e054-00144ff88e88 51079-348 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/Macrocrystals Nitrofurantoin Monohydrate and Nitrofurantoin macrocrystalline CAPSULE ORAL 20070212 ANDA ANDA076648 Mylan Institutional Inc. NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 51079-349_4834cd2d-371c-1edc-e054-00144ff8d46c 51079-349 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20141111 ANDA ANDA091151 Mylan Institutional Inc. ESZOPICLONE 2 mg/1 CIV N 20181231 51079-353_5d6d7684-d4f1-d0ec-e053-2a91aa0aa1e0 51079-353 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140930 20180228 ANDA ANDA202395 Mylan Institutional Inc. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-354_5d6d7684-d4f1-d0ec-e053-2a91aa0aa1e0 51079-354 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20140930 20180228 ANDA ANDA202395 Mylan Institutional Inc. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-374_604f966c-359e-a6ab-e053-2991aa0a8890 51079-374 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19951208 ANDA ANDA084768 Mylan Institutional Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-375_604f966c-359e-a6ab-e053-2991aa0a8890 51079-375 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19960305 ANDA ANDA083116 Mylan Institutional Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-379_d4152532-a31b-4e89-9757-1f5f8e584c9b 51079-379 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil TABLET, FILM COATED ORAL 20090601 ANDA ANDA065521 Mylan Institutional Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 51079-383_17878178-1117-43e2-b116-d9b98b404890 51079-383 HUMAN PRESCRIPTION DRUG Ursodiol ursodiol CAPSULE ORAL 20160125 ANDA ANDA090530 Mylan Institutional Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 51079-385_4409e2b9-4a20-0ee5-e054-00144ff88e88 51079-385 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19950928 ANDA ANDA070541 Mylan Institutional Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 51079-386_5d6a9409-7fc2-3ba2-e053-2a91aa0a8aac 51079-386 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20040119 ANDA ANDA077657 Mylan Institutional Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-387_5d6a9409-7fc2-3ba2-e053-2a91aa0a8aac 51079-387 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061228 ANDA ANDA077657 Mylan Institutional Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-391_4faadbea-891b-6914-e054-00144ff8d46c 51079-391 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100528 ANDA ANDA090325 Mylan Institutional Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 51079-392_4faadbea-891b-6914-e054-00144ff8d46c 51079-392 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100528 ANDA ANDA090325 Mylan Institutional Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 51079-400_4834a7fe-acfe-5f71-e054-00144ff88e88 51079-400 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100913 ANDA ANDA090649 Mylan Institutional Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 51079-414_4834cd2d-371c-1edc-e054-00144ff8d46c 51079-414 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20141111 ANDA ANDA091151 Mylan Institutional Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 51079-417_5d6a9409-7fc2-3ba2-e053-2a91aa0a8aac 51079-417 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20040116 ANDA ANDA077657 Mylan Institutional Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-418_cb971f84-14dd-46cf-ace3-5fcb6e64188f 51079-418 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19970429 ANDA ANDA070920 Mylan Institutional Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-419_cb971f84-14dd-46cf-ace3-5fcb6e64188f 51079-419 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19970502 ANDA ANDA070920 Mylan Institutional Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-423_46012f43-8e98-3ef0-e054-00144ff88e88 51079-423 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20140903 ANDA ANDA202640 Mylan Institutional Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 51079-425_520108b0-be5a-6703-e054-00144ff8d46c 51079-425 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20060327 ANDA ANDA077624 Mylan Institutional Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 51079-426_520108b0-be5a-6703-e054-00144ff8d46c 51079-426 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20060327 ANDA ANDA077624 Mylan Institutional Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 51079-431_5de624c6-50e2-0781-e053-2991aa0a7d90 51079-431 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20090803 ANDA ANDA070278 Mylan Institutional Inc. HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] N 20181231 51079-433_5bed1969-1cab-87a8-e053-2991aa0a1a6c 51079-433 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19981026 NDA NDA019129 Mylan Institutional Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51079-434_476bf283-3f03-19d2-e054-00144ff8d46c 51079-434 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 19970807 ANDA ANDA074621 Mylan Institutional Inc. MEGESTROL ACETATE 20 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 51079-436_41e70182-7fc6-67e7-e054-00144ff8d46c 51079-436 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19980612 ANDA ANDA070791 Mylan Institutional Inc. DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51079-437_41e70182-7fc6-67e7-e054-00144ff8d46c 51079-437 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19980508 ANDA ANDA070791 Mylan Institutional Inc. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51079-438_41e70182-7fc6-67e7-e054-00144ff8d46c 51079-438 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19980528 ANDA ANDA070791 Mylan Institutional Inc. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51079-440_4ce74185-f449-256b-e054-00144ff8d46c 51079-440 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070205 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51079-441_4ce74185-f449-256b-e054-00144ff8d46c 51079-441 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070205 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51079-442_4ce74185-f449-256b-e054-00144ff8d46c 51079-442 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070205 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51079-443_4ce74185-f449-256b-e054-00144ff8d46c 51079-443 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070205 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51079-444_4ce74185-f449-256b-e054-00144ff8d46c 51079-444 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070226 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51079-445_4ce74185-f449-256b-e054-00144ff8d46c 51079-445 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070226 ANDA ANDA076187 Mylan Institutional Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51079-450_5d6a9409-806d-3ba2-e053-2a91aa0a8aac 51079-450 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20070402 ANDA ANDA076418 Mylan Institutional Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 51079-451_5d6a9409-806d-3ba2-e053-2a91aa0a8aac 51079-451 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20070402 ANDA ANDA076418 Mylan Institutional Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 51079-452_5d6a9409-806d-3ba2-e053-2a91aa0a8aac 51079-452 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20070402 ANDA ANDA076418 Mylan Institutional Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 51079-453_5cef4e41-dc21-6148-e053-2a91aa0a6d0e 51079-453 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20060911 ANDA ANDA076577 Mylan Institutional Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 51079-454_319f5356-2dd4-44f4-9040-68a8becd3812 51079-454 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060710 ANDA ANDA076052 Mylan Institutional Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51079-455_319f5356-2dd4-44f4-9040-68a8becd3812 51079-455 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060710 ANDA ANDA076052 Mylan Institutional Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51079-456_319f5356-2dd4-44f4-9040-68a8becd3812 51079-456 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060710 ANDA ANDA076052 Mylan Institutional Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51079-458_5022f35c-d500-2dc3-e054-00144ff88e88 51079-458 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060522 ANDA ANDA076056 Mylan Institutional Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51079-460_5d6a7266-fa5e-906e-e053-2991aa0a5fb8 51079-460 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081006 ANDA ANDA076288 Mylan Institutional Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-461_5d6a7266-fa5e-906e-e053-2991aa0a5fb8 51079-461 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081006 ANDA ANDA076288 Mylan Institutional Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-462_5d6a7266-fa5e-906e-e053-2991aa0a5fb8 51079-462 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081006 ANDA ANDA076288 Mylan Institutional Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-463_5d6a7266-fa5e-906e-e053-2991aa0a5fb8 51079-463 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081006 ANDA ANDA076288 Mylan Institutional Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-464_5d6a7266-fa5e-906e-e053-2991aa0a5fb8 51079-464 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081006 ANDA ANDA076288 Mylan Institutional Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-465_5d6a7266-fa5e-906e-e053-2991aa0a5fb8 51079-465 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081006 ANDA ANDA076288 Mylan Institutional Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-466_5e0aabe6-0929-4386-e053-2991aa0ac495 51079-466 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 20100604 ANDA ANDA075281 Mylan Institutional Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51079-467_9e61aa56-3f3e-44f0-9822-afb7fd4ae714 51079-467 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080501 ANDA ANDA078855 Mylan Institutional Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 51079-468_9e61aa56-3f3e-44f0-9822-afb7fd4ae714 51079-468 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080501 ANDA ANDA078855 Mylan Institutional Inc. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 51079-480_5d6a9409-7fdd-3ba2-e053-2a91aa0a8aac 51079-480 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20080715 ANDA ANDA077166 Mylan Institutional Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51079-482_5d6a9409-7fdd-3ba2-e053-2a91aa0a8aac 51079-482 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20080715 ANDA ANDA077166 Mylan Institutional Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51079-485_5de10025-ded5-5e57-e053-2a91aa0a3c90 51079-485 HUMAN PRESCRIPTION DRUG Fluphenazine hydrochloride Fluphenazine hydrochloride TABLET, FILM COATED ORAL 19980430 ANDA ANDA089804 Mylan Institutional Inc. FLUPHENAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-486_5de10025-ded5-5e57-e053-2a91aa0a3c90 51079-486 HUMAN PRESCRIPTION DRUG Fluphenazine hydrochloride Fluphenazine hydrochloride TABLET, FILM COATED ORAL 19980602 ANDA ANDA089804 Mylan Institutional Inc. FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-487_5de10025-ded5-5e57-e053-2a91aa0a3c90 51079-487 HUMAN PRESCRIPTION DRUG Fluphenazine hydrochloride Fluphenazine hydrochloride TABLET, FILM COATED ORAL 19980604 ANDA ANDA089804 Mylan Institutional Inc. FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-488_5de10025-ded5-5e57-e053-2a91aa0a3c90 51079-488 HUMAN PRESCRIPTION DRUG Fluphenazine hydrochloride Fluphenazine hydrochloride TABLET, FILM COATED ORAL 19980715 ANDA ANDA089804 Mylan Institutional Inc. FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-498_46012f43-8ef4-3ef0-e054-00144ff88e88 51079-498 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20090302 ANDA ANDA077420 Mylan Institutional Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 51079-499_46012f43-8ef4-3ef0-e054-00144ff88e88 51079-499 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20090302 ANDA ANDA077420 Mylan Institutional Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 51079-508_5d9579bf-1076-a41e-e053-2a91aa0ab9ac 51079-508 HUMAN PRESCRIPTION DRUG Mycophenolic Acid mycophenilic acid TABLET, DELAYED RELEASE ORAL 20140120 ANDA ANDA091248 Mylan Institutional Inc. MYCOPHENOLIC ACID 180 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 51079-509_5d9579bf-1076-a41e-e053-2a91aa0ab9ac 51079-509 HUMAN PRESCRIPTION DRUG Mycophenolic Acid mycophenilic acid TABLET, DELAYED RELEASE ORAL 20140120 ANDA ANDA091248 Mylan Institutional Inc. MYCOPHENOLIC ACID 360 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 51079-510_60152f4a-c23f-7eb1-e053-2a91aa0a7846 51079-510 HUMAN PRESCRIPTION DRUG Capecitabine capecitabine TABLET, FILM COATED ORAL 20140121 ANDA ANDA090943 Mylan Institutional Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 51079-511_46012f43-8e98-3ef0-e054-00144ff88e88 51079-511 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20140903 ANDA ANDA202640 Mylan Institutional Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 51079-513_747f9667-0699-44ed-8802-e10221b2b483 51079-513 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120906 ANDA ANDA076801 Mylan Institutional Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 51079-514_747f9667-0699-44ed-8802-e10221b2b483 51079-514 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120906 ANDA ANDA076801 Mylan Institutional Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 51079-515_747f9667-0699-44ed-8802-e10221b2b483 51079-515 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120906 ANDA ANDA076801 Mylan Institutional Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 51079-516_5bed9894-9431-3e64-e053-2a91aa0a301b 51079-516 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19941128 ANDA ANDA084114 Mylan Institutional Inc. CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-517_5bed9894-9431-3e64-e053-2a91aa0a301b 51079-517 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19941128 ANDA ANDA084115 Mylan Institutional Inc. CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-518_5bed9894-9431-3e64-e053-2a91aa0a301b 51079-518 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19941123 ANDA ANDA083386 Mylan Institutional Inc. CHLORPROMAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-519_5bed9894-9431-3e64-e053-2a91aa0a301b 51079-519 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19941123 ANDA ANDA084112 Mylan Institutional Inc. CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-524_5cc53a8f-4db7-7cff-e053-2991aa0a383b 51079-524 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron TABLET, FILM COATED ORAL 20070709 ANDA ANDA076930 Mylan Institutional Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 51079-525_5cc53a8f-4db7-7cff-e053-2991aa0a383b 51079-525 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron TABLET, FILM COATED ORAL 20070709 ANDA ANDA076930 Mylan Institutional Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 51079-527_5de62de5-734a-3bb9-e053-2991aa0acd32 51079-527 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19960201 ANDA ANDA070082 Mylan Institutional Inc. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 51079-539_5bed7cb1-1e65-202e-e053-2a91aa0a9886 51079-539 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20140227 ANDA ANDA090252 Mylan Institutional Inc. REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 51079-541_d259483d-f21a-4dc6-b504-32a0cc95b3e0 51079-541 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 19970415 ANDA ANDA040185 Mylan Institutional Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-542_d259483d-f21a-4dc6-b504-32a0cc95b3e0 51079-542 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine mealeate TABLET, FILM COATED ORAL 19970415 ANDA ANDA040185 Mylan Institutional Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-543_5cc564c1-324d-9b0e-e053-2a91aa0a218b 51079-543 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20120229 NDA NDA021323 Mylan Institutional Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51079-544_5cc564c1-324d-9b0e-e053-2a91aa0a218b 51079-544 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20120229 NDA NDA021323 Mylan Institutional Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51079-547_4b68565d-4c02-16d8-e054-00144ff88e88 51079-547 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20120213 ANDA ANDA077081 Mylan Institutional Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 51079-548_4b68565d-4c02-16d8-e054-00144ff88e88 51079-548 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110927 ANDA ANDA077081 Mylan Institutional Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 51079-550_5d95c1d7-113b-e701-e053-2a91aa0a1a85 51079-550 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir OINTMENT TOPICAL 20131127 ANDA ANDA202459 Mylan Institutional Inc. ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 51079-555_5bed7cb1-1e65-202e-e053-2a91aa0a9886 51079-555 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20140224 ANDA ANDA090252 Mylan Institutional Inc. REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 51079-557_51fffacd-e767-25b6-e054-00144ff88e88 51079-557 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA077665 Mylan Institutional Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 51079-558_51fffacd-e767-25b6-e054-00144ff88e88 51079-558 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA077665 Mylan Institutional Inc. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 51079-561_4820d300-b01c-1102-e054-00144ff88e88 51079-561 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20120906 ANDA ANDA076594 Mylan Institutional Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 51079-562_4820d300-b01c-1102-e054-00144ff88e88 51079-562 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20120906 ANDA ANDA076594 Mylan Institutional Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 51079-563_465169b9-d554-4d9c-e054-00144ff88e88 51079-563 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19941213 ANDA ANDA086009 Mylan Institutional Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51079-565_aa298087-6867-4556-a2dc-176ce80a1b40 51079-565 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 19980429 ANDA ANDA088004 Mylan Institutional Inc. THIORIDAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-566_aa298087-6867-4556-a2dc-176ce80a1b40 51079-566 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 19950612 ANDA ANDA088004 Mylan Institutional Inc. THIORIDAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-567_aa298087-6867-4556-a2dc-176ce80a1b40 51079-567 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 19980506 ANDA ANDA088004 Mylan Institutional Inc. THIORIDAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-572_20df546b-2043-486b-87a4-6652792f2d58 51079-572 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 19980304 ANDA ANDA040209 Mylan Institutional Inc. TRIFLUOPERAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-573_20df546b-2043-486b-87a4-6652792f2d58 51079-573 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 19980304 ANDA ANDA040209 Mylan Institutional Inc. TRIFLUOPERAZINE HYDROCHLORIDE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-574_20df546b-2043-486b-87a4-6652792f2d58 51079-574 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 19980304 ANDA ANDA040209 Mylan Institutional Inc. TRIFLUOPERAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-575_20df546b-2043-486b-87a4-6652792f2d58 51079-575 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 19980304 ANDA ANDA040209 Mylan Institutional Inc. TRIFLUOPERAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-580_aa298087-6867-4556-a2dc-176ce80a1b40 51079-580 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 19980622 ANDA ANDA088004 Mylan Institutional Inc. THIORIDAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-581_5cef0d78-9988-f37e-e053-2a91aa0af096 51079-581 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19960226 ANDA ANDA071198 Mylan Institutional Inc. LEUCOVORIN CALCIUM 5 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 51079-582_5cef0d78-9988-f37e-e053-2a91aa0af096 51079-582 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 19970827 ANDA ANDA071199 Mylan Institutional Inc. LEUCOVORIN CALCIUM 25 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 51079-584_667a47dd-0d60-4da8-88d1-ff336b6102b4 51079-584 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 20060816 ANDA ANDA074967 Mylan Institutional Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 51079-585_667a47dd-0d60-4da8-88d1-ff336b6102b4 51079-585 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 20060816 ANDA ANDA077025 Mylan Institutional Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 51079-587_b5aebe5d-f6c7-4e47-8623-e1f949472cbe 51079-587 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19980309 ANDA ANDA071093 Mylan Institutional Inc. THIOTHIXENE 2 mg/1 Typical Antipsychotic [EPC] N 20181231 51079-588_b5aebe5d-f6c7-4e47-8623-e1f949472cbe 51079-588 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19980305 ANDA ANDA071093 Mylan Institutional Inc. THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] N 20181231 51079-589_b5aebe5d-f6c7-4e47-8623-e1f949472cbe 51079-589 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19980724 ANDA ANDA071093 Mylan Institutional Inc. THIOTHIXENE 10 mg/1 Typical Antipsychotic [EPC] N 20181231 51079-597_4b681c29-c0a3-0649-e054-00144ff8d46c 51079-597 HUMAN OTC DRUG Cetirizine Hydrochloride cetirizine hydrochloride TABLET, FILM COATED ORAL 20120330 ANDA ANDA076677 Mylan Institutional Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 51079-599_5fc50ed4-7ad8-4b0c-8110-9f43b7cb80fd 51079-599 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20130610 ANDA ANDA202856 Mylan Institutional Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 51079-608_5fc50ed4-7ad8-4b0c-8110-9f43b7cb80fd 51079-608 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20130610 ANDA ANDA202856 Mylan Institutional Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 51079-620_406c2bbd-4adc-1237-e054-00144ff88e88 51079-620 HUMAN PRESCRIPTION DRUG Azathioprine azathioprine TABLET ORAL 20100723 ANDA ANDA075568 Mylan Institutional Inc. AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 51079-621_229e6420-ed55-46c6-a696-471e008d4562 51079-621 HUMAN PRESCRIPTION DRUG Granulex trypsin, balsam peru and castor oil SPRAY TOPICAL 19670301 20180531 UNAPPROVED DRUG OTHER Mylan Institutional Inc. CASTOR OIL; BALSAM PERU; TRYPSIN, UNSPECIFIED FORM 788; 87; .12 mg/g; mg/g; mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 51079-622_d0838819-7e2d-4033-a02d-6920b8f080bf 51079-622 HUMAN OTC DRUG Proderm castor oil and balsam peru SPRAY TOPICAL 20120926 20180430 UNAPPROVED DRUG OTHER Mylan Institutional Inc. CASTOR OIL; BALSAM PERU 788; 87 mg/g; mg/g N 20181231 51079-623_0e27c939-54ac-4d98-905b-56dfc40c1f68 51079-623 HUMAN PRESCRIPTION DRUG Sulfamylon Mafenide Acetate CREAM TOPICAL 20061208 NDA NDA016763 Mylan Institutional Inc. MAFENIDE ACETATE 85 mg/g Methylated Sulfonamide Antibacterial [EPC],Methylated Sulfonamides [Chemical/Ingredient] N 20181231 51079-624_27f53ade-2a34-443d-850f-41b6db649c0a 51079-624 HUMAN PRESCRIPTION DRUG Sulfamylon mafenide acetate POWDER, FOR SOLUTION TOPICAL 19980605 NDA NDA019832 Mylan Institutional Inc. MAFENIDE ACETATE 50 g/1 Methylated Sulfonamide Antibacterial [EPC],Methylated Sulfonamides [Chemical/Ingredient] N 20181231 51079-630_5d6a9409-7fa4-3ba2-e053-2a91aa0a8aac 51079-630 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19981005 ANDA ANDA072575 Mylan Institutional Inc. PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51079-631_5d6a9409-7fa4-3ba2-e053-2a91aa0a8aac 51079-631 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19981006 ANDA ANDA072575 Mylan Institutional Inc. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51079-632_5d6a9409-7fa4-3ba2-e053-2a91aa0a8aac 51079-632 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19981006 ANDA ANDA072575 Mylan Institutional Inc. PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51079-644_3d07057a-86a1-29b6-e054-00144ff88e88 51079-644 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 19970825 ANDA ANDA073144 Mylan Institutional Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 51079-651_41e70182-7fc6-67e7-e054-00144ff8d46c 51079-651 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19980602 ANDA ANDA070791 Mylan Institutional Inc. DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51079-657_5d6d7684-d556-d0ec-e053-2a91aa0aa1e0 51079-657 HUMAN PRESCRIPTION DRUG Albuterol albuterol TABLET ORAL 19970429 ANDA ANDA072894 Mylan Institutional Inc. ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 51079-658_5d6d7684-d556-d0ec-e053-2a91aa0aa1e0 51079-658 HUMAN PRESCRIPTION DRUG Albuterol albuterol TABLET ORAL 19970429 ANDA ANDA072894 Mylan Institutional Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 51079-667_7f4a9c6d-4d4b-469d-a27a-f1a8852207cc 51079-667 HUMAN PRESCRIPTION DRUG Sulindac sulindac TABLET ORAL 19970131 ANDA ANDA073039 Mylan Institutional Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51079-670_40e599a4-6d33-03d5-e054-00144ff8d46c 51079-670 HUMAN PRESCRIPTION DRUG Methotrexate methotrexate TABLET ORAL 19950713 ANDA ANDA081235 Mylan Institutional Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 51079-684_32832b0f-0b41-27ce-e054-00144ff8d46c 51079-684 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 19970724 ANDA ANDA073457 Mylan Institutional Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-685_32832b0f-0b41-27ce-e054-00144ff8d46c 51079-685 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 19970723 ANDA ANDA073457 Mylan Institutional Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-690_5d956a2c-7260-833b-e053-2a91aa0a911e 51079-690 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 19970310 ANDA ANDA072741 Mylan Institutional Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 51079-700_17babdce-9f90-4621-8786-e9f4a4d9d4e0 51079-700 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20100614 ANDA ANDA040821 Mylan Institutional Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 51079-721_d4152532-a31b-4e89-9757-1f5f8e584c9b 51079-721 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil CAPSULE ORAL 20090601 ANDA ANDA065520 Mylan Institutional Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 51079-722_1bfb1812-1826-4db1-b455-ecaba3a9fbf6 51079-722 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061127 ANDA ANDA076702 Mylan Institutional Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 51079-723_1bfb1812-1826-4db1-b455-ecaba3a9fbf6 51079-723 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061127 ANDA ANDA076644 Mylan Institutional Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 51079-724_d2ff928e-2a36-4b67-a457-8fa6278e2b05 51079-724 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070501 ANDA ANDA076578 Mylan Institutional Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 51079-725_d2ff928e-2a36-4b67-a457-8fa6278e2b05 51079-725 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070501 ANDA ANDA076578 Mylan Institutional Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 51079-733_5de624c6-50e2-0781-e053-2991aa0a7d90 51079-733 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20040201 ANDA ANDA070278 Mylan Institutional Inc. HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] N 20181231 51079-734_5de624c6-50e2-0781-e053-2991aa0a7d90 51079-734 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20040201 ANDA ANDA070278 Mylan Institutional Inc. HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] N 20181231 51079-735_5de624c6-50e2-0781-e053-2991aa0a7d90 51079-735 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20040215 ANDA ANDA070278 Mylan Institutional Inc. HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] N 20181231 51079-736_5de624c6-50e2-0781-e053-2991aa0a7d90 51079-736 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20040215 ANDA ANDA070278 Mylan Institutional Inc. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 51079-745_886d8f86-033e-4bfb-86bc-babc5c1b0672 51079-745 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19960307 ANDA ANDA072838 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 51079-746_886d8f86-033e-4bfb-86bc-babc5c1b0672 51079-746 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19960307 ANDA ANDA072838 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 51079-747_886d8f86-033e-4bfb-86bc-babc5c1b0672 51079-747 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19960307 ANDA ANDA072838 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 51079-749_5bed1969-1ce0-87a8-e053-2991aa0a1a6c 51079-749 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 20100706 ANDA ANDA075417 Mylan Institutional Inc. CLOZAPINE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-753_32fab4b2-3181-6c31-e054-00144ff88e88 51079-753 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20130924 ANDA ANDA070848 Mylan Institutional Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 51079-759_32832b0f-0b41-27ce-e054-00144ff8d46c 51079-759 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 19990616 ANDA ANDA073457 Mylan Institutional Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-766_63ee5ac5-eaee-740d-e053-2991aa0aa940 51079-766 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090203 ANDA ANDA077567 Mylan Institutional Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 51079-767_63ee5ac5-eaee-740d-e053-2991aa0aa940 51079-767 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090203 ANDA ANDA077567 Mylan Institutional Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 51079-768_50d8c3aa-6f2c-57ad-e054-00144ff88e88 51079-768 HUMAN PRESCRIPTION DRUG Zonisamide zonisamide CAPSULE ORAL 20060125 ANDA ANDA077637 Mylan Institutional Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51079-771_3e38442d-2e3e-0a95-e054-00144ff8d46c 51079-771 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070914 ANDA ANDA077316 Mylan Institutional Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 51079-774_d3e64d75-cbc3-487a-a8f8-7c3d0930d958 51079-774 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20051226 ANDA ANDA078902 Mylan Institutional Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51079-776_1b2265d6-1d4f-4cb7-a6e6-61ce6b8df0f1 51079-776 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20051101 ANDA ANDA075640 Mylan Institutional Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51079-777_5de62de5-7306-3bb9-e053-2991aa0acd32 51079-777 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20070910 ANDA ANDA040655 Mylan Institutional Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 51079-778_5de62de5-7306-3bb9-e053-2991aa0acd32 51079-778 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20070910 ANDA ANDA040656 Mylan Institutional Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 51079-779_5de62de5-7306-3bb9-e053-2991aa0acd32 51079-779 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20070910 ANDA ANDA040355 Mylan Institutional Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 51079-782_5022f35c-d500-2dc3-e054-00144ff88e88 51079-782 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20071003 ANDA ANDA076056 Mylan Institutional Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51079-788_13ae2612-ab74-4dd8-a708-f850a10f63f4 51079-788 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19981026 ANDA ANDA074215 Mylan Institutional Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-789_13ae2612-ab74-4dd8-a708-f850a10f63f4 51079-789 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19981023 ANDA ANDA074215 Mylan Institutional Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-790_13ae2612-ab74-4dd8-a708-f850a10f63f4 51079-790 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19981023 ANDA ANDA074215 Mylan Institutional Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-796_46617423-7a2a-2473-e054-00144ff88e88 51079-796 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100813 ANDA ANDA091176 Mylan Institutional Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 51079-801_4fe11562-6f67-4eb2-e054-00144ff88e88 51079-801 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940503 ANDA ANDA076704 Mylan Institutional Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-802_4fe11562-6f67-4eb2-e054-00144ff88e88 51079-802 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940503 ANDA ANDA076704 Mylan Institutional Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-806_46617423-7a2a-2473-e054-00144ff88e88 51079-806 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100813 ANDA ANDA091176 Mylan Institutional Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 51079-810_50eda997-68a8-70a6-e054-00144ff88e88 51079-810 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 19940712 ANDA ANDA074226 Mylan Institutional Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 51079-811_50eda997-68a8-70a6-e054-00144ff88e88 51079-811 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 19940712 ANDA ANDA074226 Mylan Institutional Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 51079-812_4834938f-939f-118c-e054-00144ff8d46c 51079-812 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 19940712 ANDA ANDA074172 Mylan Institutional Inc. NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-813_4834938f-939f-118c-e054-00144ff8d46c 51079-813 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 19940712 ANDA ANDA074172 Mylan Institutional Inc. NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-816_46617423-7a2a-2473-e054-00144ff88e88 51079-816 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100813 ANDA ANDA091176 Mylan Institutional Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 51079-817_478ffcf5-42c6-4275-8571-e8ade81fa7a5 51079-817 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20101115 ANDA ANDA090596 Mylan Institutional Inc. TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 51079-818_478ffcf5-42c6-4275-8571-e8ade81fa7a5 51079-818 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20101101 ANDA ANDA090596 Mylan Institutional Inc. TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 51079-820_4cd6b5b1-da12-56ef-e054-00144ff8d46c 51079-820 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 Mylan Institutional Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51079-821_4cd6b5b1-da12-56ef-e054-00144ff8d46c 51079-821 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 Mylan Institutional Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51079-822_4cd6b5b1-da12-56ef-e054-00144ff8d46c 51079-822 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20081104 ANDA ANDA076919 Mylan Institutional Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51079-852_5b33322a-d1fc-0bdc-e053-2a91aa0aeaec 51079-852 HUMAN PRESCRIPTION DRUG Galantamine galantamine TABLET, FILM COATED ORAL 20091109 ANDA ANDA077590 Mylan Institutional Inc. GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 51079-853_5b33322a-d1fc-0bdc-e053-2a91aa0aeaec 51079-853 HUMAN PRESCRIPTION DRUG Galantamine galantamine TABLET, FILM COATED ORAL 20091109 ANDA ANDA077590 Mylan Institutional Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 51079-860_4cd6b5b1-da12-56ef-e054-00144ff8d46c 51079-860 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20100324 ANDA ANDA090261 Mylan Institutional Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51079-863_40e525f9-869d-1e39-e054-00144ff88e88 51079-863 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 19960214 ANDA ANDA074434 Mylan Institutional Inc. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51079-864_40e525f9-869d-1e39-e054-00144ff88e88 51079-864 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 19960214 ANDA ANDA074434 Mylan Institutional Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51079-865_46012f43-8ef4-3ef0-e054-00144ff88e88 51079-865 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20090619 ANDA ANDA077420 Mylan Institutional Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 51079-866_46012f43-8ef4-3ef0-e054-00144ff88e88 51079-866 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20090619 ANDA ANDA077420 Mylan Institutional Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 51079-868_4601440b-a9ff-41bd-e054-00144ff88e88 51079-868 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 19960501 ANDA ANDA074461 Mylan Institutional Inc. INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 51079-869_46012f43-8ffd-3ef0-e054-00144ff88e88 51079-869 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960415 ANDA ANDA074587 Mylan Institutional Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51079-870_4409e2b9-4a20-0ee5-e054-00144ff88e88 51079-870 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 19960515 ANDA ANDA073524 Mylan Institutional Inc. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 51079-872_4834938f-9343-118c-e054-00144ff8d46c 51079-872 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19960730 ANDA ANDA074388 Mylan Institutional Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 51079-873_4834938f-9343-118c-e054-00144ff8d46c 51079-873 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19960730 ANDA ANDA074388 Mylan Institutional Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 51079-879_09a6458e-e1e8-4640-9341-396676319125 51079-879 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 19970711 ANDA ANDA074467 Mylan Institutional Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 51079-881_5b33322a-d1a8-0bdc-e053-2a91aa0aeaec 51079-881 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 19970715 ANDA ANDA075150 Mylan Institutional Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-882_5b33322a-d1a8-0bdc-e053-2a91aa0aeaec 51079-882 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 19970715 ANDA ANDA075150 Mylan Institutional Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-883_5b33322a-d1a8-0bdc-e053-2a91aa0aeaec 51079-883 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 19970715 ANDA ANDA075150 Mylan Institutional Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51079-884_4b88ebc1-7088-4f16-9685-b2f5da3b6146 51079-884 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20100127 ANDA ANDA090324 Mylan Institutional Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 51079-886_4d9e7b5b-12bf-2078-e054-00144ff88e88 51079-886 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20131230 ANDA ANDA072801 Mylan Institutional Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 51079-888_4d9e7b5b-12bf-2078-e054-00144ff88e88 51079-888 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20140102 ANDA ANDA070184 Mylan Institutional Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 51079-889_5bed416f-0615-1e9a-e053-2991aa0a5d5f 51079-889 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 19980115 ANDA ANDA074425 Mylan Institutional Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 51079-890_fc9e4e42-b883-4853-a3fa-f7c930bf8e0e 51079-890 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 19991215 ANDA ANDA064150 Mylan Institutional Inc. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 51079-894_46012f43-8ffd-3ef0-e054-00144ff88e88 51079-894 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19980417 ANDA ANDA074587 Mylan Institutional Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51079-895_ad43db9f-8ed1-4eef-a59d-90f6fd0027ee 51079-895 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20070201 ANDA ANDA040596 Mylan Institutional Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51079-896_4834a7fe-acfe-5f71-e054-00144ff88e88 51079-896 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101001 ANDA ANDA090649 Mylan Institutional Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 51079-897_4834a7fe-acfe-5f71-e054-00144ff88e88 51079-897 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100820 ANDA ANDA090649 Mylan Institutional Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 51079-899_46012f43-8ffd-3ef0-e054-00144ff88e88 51079-899 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19981115 ANDA ANDA074587 Mylan Institutional Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51079-901_5de109af-cd15-1668-e053-2a91aa0afaee 51079-901 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041215 ANDA ANDA076762 Mylan Institutional Inc. LOXAPINE SUCCINATE 10 mg/1 N 20181231 51079-902_5de109af-cd15-1668-e053-2a91aa0afaee 51079-902 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041215 ANDA ANDA076762 Mylan Institutional Inc. LOXAPINE SUCCINATE 25 mg/1 N 20181231 51079-903_5de109af-cd15-1668-e053-2a91aa0afaee 51079-903 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20041215 ANDA ANDA076762 Mylan Institutional Inc. LOXAPINE SUCCINATE 50 mg/1 N 20181231 51079-905_5d957668-6b0f-3b33-e053-2991aa0ac02e 51079-905 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 19990501 ANDA ANDA040298 Mylan Institutional Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 51079-906_4faa8fc7-c20a-5722-e054-00144ff8d46c 51079-906 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 19991101 ANDA ANDA074739 Mylan Institutional Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 51079-917_5200a67c-de4a-3982-e054-00144ff88e88 51079-917 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991001 ANDA ANDA075138 Mylan Institutional Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51079-921_5bed1969-1ce0-87a8-e053-2991aa0a1a6c 51079-921 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 19991115 ANDA ANDA075417 Mylan Institutional Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-922_5bed1969-1ce0-87a8-e053-2991aa0a1a6c 51079-922 HUMAN PRESCRIPTION DRUG Clozapine clozapine TABLET ORAL 19991115 ANDA ANDA075417 Mylan Institutional Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 51079-923_50676f74-4e97-4b2e-aca4-a88af9c79351 51079-923 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 20040514 ANDA ANDA075091 Mylan Institutional Inc. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 51079-924_77f38b7c-27f4-441c-9c01-cd36848e6a12 51079-924 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991215 ANDA ANDA074910 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 51079-925_77f38b7c-27f4-441c-9c01-cd36848e6a12 51079-925 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991215 ANDA ANDA074910 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 51079-926_77f38b7c-27f4-441c-9c01-cd36848e6a12 51079-926 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991215 ANDA ANDA074910 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 51079-928_08581b92-f65a-4786-8424-4f9e79df0ce6 51079-928 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20000115 ANDA ANDA075113 Mylan Institutional Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-929_08581b92-f65a-4786-8424-4f9e79df0ce6 51079-929 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20000115 ANDA ANDA075113 Mylan Institutional Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51079-930_3e38442d-2e3e-0a95-e054-00144ff8d46c 51079-930 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070914 ANDA ANDA077316 Mylan Institutional Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 51079-931_3e38442d-2e3e-0a95-e054-00144ff8d46c 51079-931 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070914 ANDA ANDA077316 Mylan Institutional Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 51079-932_3e38442d-2e3e-0a95-e054-00144ff8d46c 51079-932 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20070914 ANDA ANDA077316 Mylan Institutional Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 51079-935_035e409d-f1a1-4e44-a2c2-c98cb75c709b 51079-935 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide triamterene and hydrochlorothiazide CAPSULE ORAL 20000401 ANDA ANDA074701 Mylan Institutional Inc. HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 51079-936_9936832f-270a-475a-8707-0980c06136e0 51079-936 HUMAN PRESCRIPTION DRUG Tarazosin tarazosin CAPSULE ORAL 20000401 ANDA ANDA075140 Mylan Institutional Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51079-937_9936832f-270a-475a-8707-0980c06136e0 51079-937 HUMAN PRESCRIPTION DRUG Tarazosin tarazosin CAPSULE ORAL 20000401 ANDA ANDA075140 Mylan Institutional Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51079-938_9936832f-270a-475a-8707-0980c06136e0 51079-938 HUMAN PRESCRIPTION DRUG Tarazosin tarazosin CAPSULE ORAL 20000401 ANDA ANDA075140 Mylan Institutional Inc. TERAZOSIN HYDROCHLORIDE ANHYDROUS 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51079-941_3bffa240-c99c-3bf6-e054-00144ff88e88 51079-941 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080901 ANDA ANDA076584 Mylan Institutional Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 51079-942_3bffa240-c99c-3bf6-e054-00144ff88e88 51079-942 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20080901 ANDA ANDA076584 Mylan Institutional Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 51079-943_5cc53a8f-4e05-7cff-e053-2991aa0a383b 51079-943 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000701 ANDA ANDA075491 Mylan Institutional Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 51079-944_5cc53a8f-4e05-7cff-e053-2991aa0a383b 51079-944 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000701 ANDA ANDA075491 Mylan Institutional Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 51079-947_93b45111-68a8-4494-b371-3f0de3c6130c 51079-947 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20001001 ANDA ANDA075124 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 51079-948_93b45111-68a8-4494-b371-3f0de3c6130c 51079-948 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20001001 ANDA ANDA075124 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 51079-949_93b45111-68a8-4494-b371-3f0de3c6130c 51079-949 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20001001 ANDA ANDA075124 Mylan Institutional Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 51079-950_5d6e4c8f-dc81-72ea-e053-2991aa0aa71f 51079-950 HUMAN PRESCRIPTION DRUG Enalapril Maleate enalapril maleate TABLET ORAL 20001115 20180531 ANDA ANDA075480 Mylan Institutional Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51079-951_5d6e4c8f-dc81-72ea-e053-2991aa0aa71f 51079-951 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20001115 ANDA ANDA075480 Mylan Institutional Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51079-952_5d6e4c8f-dc81-72ea-e053-2991aa0aa71f 51079-952 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20001115 ANDA ANDA075480 Mylan Institutional Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51079-953_5d6e4c8f-dc81-72ea-e053-2991aa0aa71f 51079-953 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20001115 20180228 ANDA ANDA075480 Mylan Institutional Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51079-957_5de5447a-c9bf-efb3-e053-2a91aa0aeb4b 51079-957 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20010101 ANDA ANDA075509 Mylan Institutional Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51079-958_5de5447a-c9bf-efb3-e053-2a91aa0aeb4b 51079-958 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20010101 ANDA ANDA075509 Mylan Institutional Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51079-959_5de5447a-c9bf-efb3-e053-2a91aa0aeb4b 51079-959 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20010101 ANDA ANDA075509 Mylan Institutional Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51079-960_5cc511e4-3e80-70d6-e053-2a91aa0a8044 51079-960 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20010415 ANDA ANDA076008 Mylan Institutional Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 51079-966_c074a7f9-f247-4d52-af8d-c7b04b1350be 51079-966 HUMAN PRESCRIPTION DRUG Famotidine famotidine TABLET, FILM COATED ORAL 20010501 ANDA ANDA075704 Mylan Institutional Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 51079-975_5d6d7684-d581-d0ec-e053-2a91aa0aa1e0 51079-975 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20020115 20180228 ANDA ANDA075451 Mylan Institutional Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51079-978_50676f74-4e97-4b2e-aca4-a88af9c79351 51079-978 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 20040514 ANDA ANDA075091 Mylan Institutional Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 51079-979_5bee42f5-e1c4-577e-e053-2a91aa0aa6e0 51079-979 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20020220 ANDA ANDA040424 Mylan Institutional Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 51079-980_5bee42f5-e1c4-577e-e053-2a91aa0aa6e0 51079-980 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20020220 ANDA ANDA040424 Mylan Institutional Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 51079-981_5de580dc-63f9-3641-e053-2a91aa0ac4d4 51079-981 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020801 ANDA ANDA076071 Mylan Institutional Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51079-982_5de580dc-63f9-3641-e053-2a91aa0ac4d4 51079-982 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020801 ANDA ANDA076071 Mylan Institutional Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51079-983_5de580dc-63f9-3641-e053-2a91aa0ac4d4 51079-983 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020801 ANDA ANDA076071 Mylan Institutional Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51079-984_5de580dc-63f9-3641-e053-2a91aa0ac4d4 51079-984 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20020801 ANDA ANDA076071 Mylan Institutional Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51079-985_5cc511e4-3e80-70d6-e053-2a91aa0a8044 51079-985 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020325 ANDA ANDA076008 Mylan Institutional Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 51079-986_5cc511e4-3e80-70d6-e053-2a91aa0a8044 51079-986 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020325 ANDA ANDA076008 Mylan Institutional Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 51079-991_5d95c1d7-1157-e701-e053-2a91aa0a1a85 51079-991 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride tramadol hydrochloride TABLET, FILM COATED ORAL 20020801 ANDA ANDA075986 Mylan Institutional Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 51079-992_5d94dbc9-e8e0-40f9-e053-2a91aa0aeb6d 51079-992 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20020915 ANDA ANDA075889 Mylan Institutional Inc. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51079-993_5d94dbc9-e8e0-40f9-e053-2a91aa0aeb6d 51079-993 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20020915 ANDA ANDA075889 Mylan Institutional Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51079-994_5cc511e4-3e80-70d6-e053-2a91aa0a8044 51079-994 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20021201 ANDA ANDA076008 Mylan Institutional Inc. BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 51079-996_11823208-7e50-410a-9386-2ef2f77f1b8a 51079-996 HUMAN PRESCRIPTION DRUG PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET, FILM COATED ORAL 20030201 ANDA ANDA075998 Mylan Institutional Inc. PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] N 20181231 51079-998_d455bde1-a70d-4f20-ac5b-a7fd4e49f58a 51079-998 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20030615 ANDA ANDA076354 Mylan Institutional Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 51087-272_741e3f83-e561-4fbf-8976-00d505304958 51087-272 HUMAN OTC DRUG Antibacterial Hand Sanitizer Pocket Sprayer Alcohol SPRAY TOPICAL 20110203 OTC MONOGRAPH NOT FINAL part333E National Pen Co., LLC ALCOHOL 4.96 mL/8mL N 20181231 51096-0001_d38ebb18-16b2-484e-b78e-70409e70f7e1 51096-0001 HUMAN OTC DRUG Gluten Sensitivity Formula Lycopodium Clavatum, Pulsatilla CAPSULE ORAL 20130301 UNAPPROVED HOMEOPATHIC The Wise Alternative LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 12; 12 [hp_X]/mg; [hp_X]/mg N 20181231 51096-0002_e5de5935-98e9-422e-8345-7a8e60226bfa 51096-0002 HUMAN OTC DRUG Hypothalmu Stim Aralia Quinquefolia, Ginkgo Biloba, Hydrocotyle Asiatica, Brain, Hypothalamus, Pituitary, Phosphorus LIQUID ORAL 20121010 UNAPPROVED HOMEOPATHIC The Wise Alternative AMERICAN GINSENG; GINKGO; CENTELLA ASIATICA; PORK BRAIN; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; PHOSPHORUS; SILICON DIOXIDE 3; 3; 3; 6; 6; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 51096-0003_0b3e3b50-767c-4a9e-b1b6-dfdfb0412f1d 51096-0003 HUMAN OTC DRUG Adren Aid Aralia Quinquefolia, Avena Sativa, Glandula Suprarenalis Suis, Arsenicum Iodatum, Ignatia Amara, Lycopodium Clavatum LIQUID ORAL 20130305 UNAPPROVED HOMEOPATHIC The Wise Alternative AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; ARSENIC TRIIODIDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; ZINC 3; 3; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 51096-0004_6810d38e-fbd6-475d-8901-7fa4919872d7 51096-0004 HUMAN OTC DRUG Walnut Walnut LIQUID ORAL 20130913 UNAPPROVED HOMEOPATHIC The Wise Alternative ENGLISH WALNUT 200 [hp_C]/mL N 20181231 51096-0005_58b47510-2255-4000-854b-fd7ce344ef27 51096-0005 HUMAN PRESCRIPTION DRUG Dr. Wise Special Formula 1 Toa Free Uncaria Tomentosa LIQUID ORAL 20120927 UNAPPROVED HOMEOPATHIC J and L Health LLC dba The Wise Alternative CAT'S CLAW 6 [hp_X]/mL N 20181231 51096-0006_7f67f6a8-0fbf-443c-9f51-2afa834eb1e7 51096-0006 HUMAN OTC DRUG Anpitua Stim Adrenocorticotrophin, Agnus castus, Baryta carbonica, Calcarea carbonica, Iodium, Lac caninum, Natrum muriaticum, Phosphoricum acidum, Sepia, Thyroidinum suis, LIQUID ORAL 20120926 UNAPPROVED HOMEOPATHIC J and Health DBA Wise Alternative CORTICOTROPIN; CHASTE TREE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; CANIS LUPUS FAMILIARIS MILK; SODIUM CHLORIDE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; THYROID, PORCINE 6; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 51096-0007_62d856ca-6a26-4a86-9b9a-f075e3d84e31 51096-0007 HUMAN OTC DRUG Thyro Aid Fucus Vesiculosus, Spongia Tosta, Glandula Suprarenalis Suis, Pituitary, Thyroidinum, Bromium, Calcarea Carbonica LIQUID ORAL 20130318 UNAPPROVED HOMEOPATHIC The Wise Alternative FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; LACHESIS MUTA VENOM; PULSATILLA VULGARIS 3; 3; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 51098-742_1d8e5de7-1d23-487a-a5cc-535ac356504d 51098-742 HUMAN OTC DRUG Hands First 4 in 1 Benzalkonium Chloride, Allantoin SOLUTION TOPICAL 20100801 OTC MONOGRAPH FINAL part347 Avadim II LLC ALLANTOIN; BENZALKONIUM CHLORIDE 5; 1.3 g/1000mL; mL/1000mL E 20171231 51105-001_68ddfe17-995f-46ae-85d1-a6baa445bb80 51105-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19760101 UNAPPROVED MEDICAL GAS Wilson Products Compressed Gas Co. OXYGEN 990 mL/L E 20171231 51117-001_3953bcab-8db7-4d95-b162-3b0b69a74075 51117-001 HUMAN OTC DRUG Skincare LdeL Retinol Day Broad Spectrum SPF 20 Avobenzone, Homosalate, Oxybenzone, and Octinoxate CREAM TOPICAL 20120905 OTC MONOGRAPH FINAL part352 Beauty Solutions, Ltd. AVOBENZONE; HOMOSALATE; OXYBENZONE; OCTINOXATE 20; 30; 50; 75 mg/g; mg/g; mg/g; mg/g E 20171231 51121-035_6fcaf2ef-0976-4542-bb44-66f6c16e9568 51121-035 HUMAN OTC DRUG Burnaid Burn Gel Tea Tree Oil GEL TOPICAL 20131104 UNAPPROVED DRUG OTHER Clear Healthcare LLC TEA TREE OIL 10 mg/g E 20171231 51125-005_4a4e7bc3-52c2-4124-a521-2b85379a2c35 51125-005 HUMAN PRESCRIPTION DRUG Ultramicrosize Griseofulvin Ultramicrosize Griseofulvin Tablets TABLET, COATED ORAL 20140929 20190731 ANDA ANDA204371 RiconPharma LLC. GRISEOFULVIN 125 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 51125-006_4a4e7bc3-52c2-4124-a521-2b85379a2c35 51125-006 HUMAN PRESCRIPTION DRUG Ultramicrosize Griseofulvin Ultramicrosize Griseofulvin Tablets TABLET, COATED ORAL 20140929 20190731 ANDA ANDA204371 RiconPharma LLC. GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 51125-010_ed602d42-fa43-4e58-b34a-6506a00a4971 51125-010 HUMAN PRESCRIPTION DRUG CHLORTHALIDONE CHLORTHALIDONE TABLET ORAL 20170501 ANDA ANDA206904 RICONPHARMA LLC CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 51125-011_ed602d42-fa43-4e58-b34a-6506a00a4971 51125-011 HUMAN PRESCRIPTION DRUG CHLORTHALIDONE CHLORTHALIDONE TABLET ORAL 20170501 ANDA ANDA206904 RICONPHARMA LLC CHLORTHALIDONE 50 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 51125-400_ff728d8a-6e18-4be6-aa3f-5af5bdbcc707 51125-400 HUMAN PRESCRIPTION DRUG Mafenide Acetate Mafenide Acetate POWDER, FOR SOLUTION TOPICAL 20170731 ANDA ANDA206716 RICONPHARMA LLC MAFENIDE ACETATE 50 g/1 Methylated Sulfonamide Antibacterial [EPC],Methylated Sulfonamides [Chemical/Ingredient] N 20181231 51125-405_6c2022d8-220d-40dc-8657-b1a01f67ec23 51125-405 HUMAN PRESCRIPTION DRUG Diclofenac Sodium topical solution Diclofenac Sodium SOLUTION TOPICAL 20170807 ANDA ANDA206715 RICONPHARMA LLC DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51125-407_ce619a32-b304-4cbe-98dd-9f283ff711e5 51125-407 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate AEROSOL, FOAM TOPICAL 20170525 ANDA ANDA207144 RICONPHARMA LLC BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51125-408_3b0738cd-2a00-4973-9c56-8f6425e4eb08 51125-408 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide OINTMENT TOPICAL 20170101 ANDA ANDA206785 RICONPHARMA LLC NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 51125-409_f72edd3c-2ee6-4a23-a35e-45cf83271898 51125-409 HUMAN PRESCRIPTION DRUG Diflorasone Diacetate Diflorasone Diacetate OINTMENT TOPICAL 20170228 ANDA ANDA207440 RICONPHARMA LLC DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51125-412_3bfd0b14-d69b-485e-8a1b-38f3c178ae80 51125-412 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide Topical Aerosol SPRAY TOPICAL 20170908 ANDA ANDA206786 RICONPHARMA LLC TRIAMCINOLONE ACETONIDE .147 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51128-501_a7b9d846-412b-4bd9-a36d-68e6e8c56e7c 51128-501 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, FILM COATED ORAL 20141201 ANDA ANDA202859 Recipharm Pharmaservices Private Limited MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 51128-502_a7b9d846-412b-4bd9-a36d-68e6e8c56e7c 51128-502 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, CHEWABLE ORAL 20141201 ANDA ANDA203037 Recipharm Pharmaservices Private Limited MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 51128-503_a7b9d846-412b-4bd9-a36d-68e6e8c56e7c 51128-503 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, CHEWABLE ORAL 20141201 ANDA ANDA203037 Recipharm Pharmaservices Private Limited MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 51130-333_98f9f508-2419-4c45-aee4-4c0974423010 51130-333 HUMAN OTC DRUG CaraDerma benzoyl peroxide CREAM TOPICAL 20100902 OTC MONOGRAPH NOT FINAL part333D A Refreshing Discovery, Inc. BENZOYL PEROXIDE 1.125 g/15g E 20171231 51134-0062_e5610d61-6b49-48c3-8e0d-127a499e0d79 51134-0062 HUMAN OTC DRUG Redness reliever tetrahydrozoline HCl LIQUID OPHTHALMIC 20100829 OTC MONOGRAPH FINAL part349 Samchundang Pharm. Co., Ltd. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 51134-0064_2424bf7d-411d-457a-8687-e02248c004e5 51134-0064 HUMAN OTC DRUG Advanced relief dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl LIQUID OPHTHALMIC 20100829 OTC MONOGRAPH FINAL part349 Samchundang Pharm. Co., Ltd. TETRAHYDROZOLINE HYDROCHLORIDE; DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE .5; 1; 10; 10 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 51134-5191_010cda0b-f66b-4598-bbb0-fdf67b810afd 51134-5191 HUMAN OTC DRUG Colirio Ocusan Polyethlene glycol 400 Tetrahydrozoline HCl LIQUID OPHTHALMIC 20100801 OTC MONOGRAPH FINAL part352 Samchundang Pharm. Co., Ltd. POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE .15; .0075 mL/15mL; mL/15mL E 20171231 51138-007_5ebd1b75-510d-4dce-b880-a941d35bba5b 51138-007 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110101 ANDA ANDA073092 Med Health Pharma, LLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 51138-008_5ebd1b75-510d-4dce-b880-a941d35bba5b 51138-008 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110101 ANDA ANDA073092 Med Health Pharma, LLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 51138-017_da91ee9c-13cb-4ca0-b30c-a2686b7b699f 51138-017 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20110110 ANDA ANDA070925 Med-Health Pharma, LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 51138-018_da91ee9c-13cb-4ca0-b30c-a2686b7b699f 51138-018 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20110110 ANDA ANDA070924 Med-Health Pharma, LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 51138-019_da91ee9c-13cb-4ca0-b30c-a2686b7b699f 51138-019 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20110110 ANDA ANDA070923 Med-Health Pharma, LLC CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 51138-033_e983ec9b-9e09-4bc6-9225-0d3a6dc77008 51138-033 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110101 ANDA ANDA075483 Med Health Pharma, LLC ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 51138-034_e983ec9b-9e09-4bc6-9225-0d3a6dc77008 51138-034 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110101 ANDA ANDA075483 Med Health Pharma, LLC ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 51138-035_e983ec9b-9e09-4bc6-9225-0d3a6dc77008 51138-035 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110101 ANDA ANDA075483 Med Health Pharma, LLC ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 51138-036_e983ec9b-9e09-4bc6-9225-0d3a6dc77008 51138-036 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20110101 ANDA ANDA075483 Med Health Pharma, LLC ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 51138-038_5766088c-c0e4-423e-872e-f319090cb431 51138-038 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110101 ANDA ANDA040707 Med-Health Pharma, LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 51138-039_7575a6c9-3e24-4de4-b675-77e3312cec2d 51138-039 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20121001 ANDA ANDA078558 Med Health Pharma, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 51138-040_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-040 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 51138-041_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-041 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 51138-042_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-042 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 51138-043_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-043 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 51138-044_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-044 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 51138-045_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-045 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 51138-046_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-046 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 51138-047_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-047 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 51138-048_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-048 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 51138-049_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-049 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .3 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 51138-052_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-052 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 51138-053_61001697-ecba-4ec5-bafa-93c5a49b0094 51138-053 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20110101 NDA NDA021210 Med-Health Pharma, LLC LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 51138-054_e2447944-15e9-4074-aff0-2c90a7c04694 51138-054 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 51138-055_e2447944-15e9-4074-aff0-2c90a7c04694 51138-055 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 51138-056_e2447944-15e9-4074-aff0-2c90a7c04694 51138-056 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 51138-057_e2447944-15e9-4074-aff0-2c90a7c04694 51138-057 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 51138-058_e2447944-15e9-4074-aff0-2c90a7c04694 51138-058 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 51138-059_e2447944-15e9-4074-aff0-2c90a7c04694 51138-059 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 51138-060_e2447944-15e9-4074-aff0-2c90a7c04694 51138-060 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 51138-061_e2447944-15e9-4074-aff0-2c90a7c04694 51138-061 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 51138-062_e2447944-15e9-4074-aff0-2c90a7c04694 51138-062 HUMAN PRESCRIPTION DRUG Warfarin Sodium warfarin sodium TABLET ORAL 20110209 ANDA ANDA040301 Med-Health Pharma, LLC WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 51138-063_fd8130de-c98c-4485-9e3e-93a19f20ab87 51138-063 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110105 ANDA ANDA076063 Med-Health Pharma, LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 51138-064_fd8130de-c98c-4485-9e3e-93a19f20ab87 51138-064 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110105 ANDA ANDA076063 Med-Health Pharma, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 51138-065_fd8130de-c98c-4485-9e3e-93a19f20ab87 51138-065 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110105 ANDA ANDA076063 Med-Health Pharma, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 51138-066_fd8130de-c98c-4485-9e3e-93a19f20ab87 51138-066 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110105 ANDA ANDA076063 Med-Health Pharma, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 51138-067_fd8130de-c98c-4485-9e3e-93a19f20ab87 51138-067 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110105 ANDA ANDA076063 Med-Health Pharma, LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 51138-068_fd8130de-c98c-4485-9e3e-93a19f20ab87 51138-068 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20110105 ANDA ANDA076063 Med-Health Pharma, LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 51138-074_ab07503b-a46a-4316-bfbe-a21168f4e6f6 51138-074 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20110104 ANDA ANDA075967 Med-Health Pharma, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 51138-075_ab07503b-a46a-4316-bfbe-a21168f4e6f6 51138-075 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20110104 ANDA ANDA075967 Med-Health Pharma, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 51138-076_ab07503b-a46a-4316-bfbe-a21168f4e6f6 51138-076 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20110104 ANDA ANDA075967 Med-Health Pharma, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 51138-077_1334edb5-8e3b-4f53-b233-3a520562f41a 51138-077 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20110101 ANDA ANDA076003 Med-Health Pharma, LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 51138-093_28b1893e-46ea-406a-82bc-10435fcca4ef 51138-093 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20110115 ANDA ANDA078619 Med-Health Pharma, LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 51138-094_28b1893e-46ea-406a-82bc-10435fcca4ef 51138-094 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20110115 ANDA ANDA078619 Med-Health Pharma, LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 51138-095_28b1893e-46ea-406a-82bc-10435fcca4ef 51138-095 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20110115 ANDA ANDA078619 Med-Health Pharma, LLC FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 51138-096_c2cc607c-825f-4ada-bec8-84534c901ec2 51138-096 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110120 ANDA ANDA078512 Med-Health Pharma, LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 51138-097_c2cc607c-825f-4ada-bec8-84534c901ec2 51138-097 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110120 ANDA ANDA078512 Med-Health Pharma, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 51138-098_c2cc607c-825f-4ada-bec8-84534c901ec2 51138-098 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20110120 ANDA ANDA078512 Med-Health Pharma, LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 51138-106_13c7aebd-76c8-42fe-a2bf-fafa95664747 51138-106 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20110115 ANDA ANDA074644 Med-Health Pharma, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 51138-107_13c7aebd-76c8-42fe-a2bf-fafa95664747 51138-107 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20110115 ANDA ANDA074644 Med-Health Pharma, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 51138-108_13c7aebd-76c8-42fe-a2bf-fafa95664747 51138-108 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20110115 ANDA ANDA074644 Med-Health Pharma, LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 51138-109_13c7aebd-76c8-42fe-a2bf-fafa95664747 51138-109 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20110115 ANDA ANDA074644 Med-Health Pharma, LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 51138-211_44f7fd62-0be0-4a87-a89e-036a0445016c 51138-211 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20120202 NDA NDA021286 Med-Health Pharma, LLC OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 51138-212_44f7fd62-0be0-4a87-a89e-036a0445016c 51138-212 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20120202 NDA NDA021286 Med-Health Pharma, LLC OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 51138-213_44f7fd62-0be0-4a87-a89e-036a0445016c 51138-213 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20120202 NDA NDA021286 Med-Health Pharma, LLC OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 51138-585_48e301c4-33b2-4544-970c-1d30a22172a6 51138-585 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20110704 ANDA ANDA077397 Med-Health Pharma, LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 51138-586_48e301c4-33b2-4544-970c-1d30a22172a6 51138-586 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20110704 ANDA ANDA077864 Med-Health Pharma, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 51138-587_48e301c4-33b2-4544-970c-1d30a22172a6 51138-587 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20110704 ANDA ANDA077864 Med-Health Pharma, LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 51138-588_fdf6ae68-5234-4aac-ab0d-38fa7e87f7a3 51138-588 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20110704 ANDA ANDA077836 Med-Health Pharma, LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 51140-101_edfd4420-577f-4aff-8508-f8eb7a042404 51140-101 HUMAN OTC DRUG Assured Epsom Salt Magnesium Sulfate GRANULE ORAL 20160330 OTC MONOGRAPH NOT FINAL part334 Hefei Yatai Daily Chemical Products Co., Ltd. MAGNESIUM SULFATE HEPTAHYDRATE 100 g/100g N 20181231 51141-0002_f06a5c72-ca8a-4147-9a85-ec280e40ef7e 51141-0002 HUMAN OTC DRUG Hydrocortisone HC Hydrocortisone CREAM TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part348 Neopharm Co,. Ltd HYDROCORTISONE 1 g/100g E 20171231 51141-0005_3b72153a-2bc7-4878-baf4-af9193e68b13 51141-0005 HUMAN OTC DRUG Muscle and Joint Menthol GEL TOPICAL 20100827 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. MENTHOL 2.5 g/100g E 20171231 51141-0054_7b5b52f3-182a-4f8e-b877-68cc5e5201d1 51141-0054 HUMAN OTC DRUG Anti Itch Cream Diphenhydramine HCl, Zinc acetate CREAM TOPICAL 20100907 OTC MONOGRAPH FINAL part336 NeoPharm Co., Ltd. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g E 20171231 51141-0057_0976b365-d5b5-4396-a17e-b8a1c32616e4 51141-0057 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20100827 OTC MONOGRAPH FINAL part333C NeoPharm Co., Ltd. TOLNAFTATE 1 g/100g E 20171231 51141-0065_ff4b716a-95d0-4d1c-bea4-2fecd6bb5d3a 51141-0065 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. HYDROCORTISONE 1 h/100g E 20171231 51141-0066_2693ab26-2139-45df-8bac-d077e5f04a09 51141-0066 HUMAN OTC DRUG Antibiotic Ointment Neomycin Sulfate OINTMENT TOPICAL 20100826 OTC MONOGRAPH FINAL part333B NeoPharm Co., Ltd. NEOMYCIN SULFATE 3.5 mg/g E 20171231 51141-0070_949a5beb-b5f4-473f-82db-81fe75e86a4c 51141-0070 HUMAN OTC DRUG Triple Antibiotic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20100901 OTC MONOGRAPH FINAL part333B NeoPharm Co., Ltd BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g E 20171231 51141-0220_f7034d80-4b3a-4073-9539-ec38e1bc9684 51141-0220 HUMAN OTC DRUG ATOPALM Hemorrhoidal Pain Relieving GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM CREAM TOPICAL 20120117 OTC MONOGRAPH FINAL part346 NeoPharm USA GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g E 20171231 51141-0230_d3cf0652-d915-4d32-8f38-dc3df1283b2e 51141-0230 HUMAN OTC DRUG ATOPALM Hemorrhoidal MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE OINTMENT TOPICAL 20120718 OTC MONOGRAPH FINAL part346 NeoPharm USA MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 71.9; .25 g/100g; g/100g; g/100g E 20171231 51141-0235_376015fa-7b2c-4a5a-8a9d-faf7a3a7e7ce 51141-0235 HUMAN OTC DRUG ATOPALM Deep Penetrating Pain Relieving MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20120117 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g E 20171231 51141-0236_c4960e55-2361-47fe-a60d-bf0fbf2d0c66 51141-0236 HUMAN OTC DRUG ATOPALM Oral Pain Relief BENZOCAINE GEL ORAL 20120206 OTC MONOGRAPH NOT FINAL part356 NeoPharm, USA BENZOCAINE 10 g/100g E 20171231 51141-0237_da4fcde6-b7da-4442-ba8e-3793aa624d11 51141-0237 HUMAN OTC DRUG ATOPALM Diaper Rash ZINC OXIDE CREAM TOPICAL 20120607 OTC MONOGRAPH NOT FINAL part347 NeoPharm Co., Ltd ZINC OXIDE 10 g/100g E 20171231 51141-0238_be45bc4b-d94b-4a85-9fa2-5cb7d1880a76 51141-0238 HUMAN OTC DRUG ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING AND PAIN RELIEF BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYCIN B SULFATE, PRAMOXINE HCL OINTMENT TOPICAL 20120808 OTC MONOGRAPH FINAL part333B Neopharm Co., Ltd. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g E 20171231 51141-0239_0bb2e368-a9b1-4db4-929a-73afbdd08c7d 51141-0239 HUMAN OTC DRUG ATOPALM PAIN RELIEVING MENTHOL CREAM TOPICAL 20120814 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. MENTHOL 10 g/100g E 20171231 51141-0240_052948a7-37b8-4731-b064-2ff9721bc7a0 51141-0240 HUMAN OTC DRUG ATOPALM MUSCLE AND JOINT MENTHOL GEL TOPICAL 20120814 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. MENTHOL 2.5 g/100g E 20171231 51141-0657_84b3da7b-0fec-450f-8af3-3c38eccbb5c5 51141-0657 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20100902 OTC MONOGRAPH FINAL part333C NeoPharm Co., Ltd. CLOTRIMAZOLE 1 g/100g E 20171231 51141-0659_6ee5cd72-9e86-4526-af8a-417536369c62 51141-0659 HUMAN OTC DRUG Muscle Rub Ultra Camphor,Menthol, methyl salicylate CREAM TOPICAL 20100816 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. MENTHOL; MENTHYL SALICYLATE; CAMPHOR (NATURAL) 10; 30; 4 g/100g; g/100g; g/100g E 20171231 51141-1000_23bc6028-b07e-4d84-baf6-19207ff3da37 51141-1000 HUMAN OTC DRUG ATOPALM CLOTRIMAZOLE ANTIFUNGAL CLOTRIMAZOLE CREAM TOPICAL 20110316 OTC MONOGRAPH FINAL part333C NeoPharm Co., Ltd. CLOTRIMAZOLE 1 g/100g E 20171231 51141-2000_39effe1d-16a7-495e-9848-3bf55a9af74d 51141-2000 HUMAN OTC DRUG ATOPALM TOLNAFTATE ANTIFUNGAL TOLNAFTATE CREAM TOPICAL 20110316 OTC MONOGRAPH FINAL part333C Neopharm Co., Ltd. TOLNAFTATE 1 g/100g E 20171231 51141-3000_fcba993b-22a9-47ae-b8e5-e17307ac2681 51141-3000 HUMAN OTC DRUG Atopalm First Aid Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYCIN B SULFATE OINTMENT TOPICAL 20110316 OTC MONOGRAPH FINAL part333B Neopharm Co., Ltd. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 51141-3771_bf67676c-618d-4074-8dde-e70870d4c1c1 51141-3771 HUMAN OTC DRUG Muscle Rub Greaseless Menthol, methyl salicylate CREAM TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g E 20171231 51141-4000_5e663371-be91-4e03-b89d-8214cc73dd3c 51141-4000 HUMAN OTC DRUG Atopalm Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20110316 OTC MONOGRAPH FINAL part347 Neopharm Co, Ltd DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g E 20171231 51141-5000_a7a73c10-c204-4711-9818-283fce849ac4 51141-5000 HUMAN OTC DRUG ATOPALM MOISTURIZING MUSCLE RUB CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20110316 OTC MONOGRAPH NOT FINAL part346 NeoPharm Co., Ltd. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g E 20171231 51141-6000_74b83355-8af7-440f-9c35-36660fc5d474 51141-6000 HUMAN OTC DRUG ATOPALM Moisturizing Hydrocortisone HYDROCORTISONE CREAM TOPICAL 20110317 OTC MONOGRAPH NOT FINAL part348 NeoPharm Co., Ltd. HYDROCORTISONE 1 g/100g E 20171231 51141-6010_710fc8e8-7ab6-4ef3-814a-05f52360f8b9 51141-6010 HUMAN OTC DRUG Atopalm Maximum Strength Anti-Itch HYDROCORTISONE OINTMENT TOPICAL 20111104 OTC MONOGRAPH FINAL part348 NeoPharm Co., Ltd. HYDROCORTISONE 1 g/100g E 20171231 51141-7000_7504a18f-1c22-4f87-95f3-97b65a9a9976 51141-7000 HUMAN OTC DRUG Atopalm Acne Controlling SALICYLIC ACID LOTION TOPICAL 20111104 OTC MONOGRAPH FINAL part333D NeoPharm Co., Ltd. SALICYLIC ACID 2 mL/100mL E 20171231 51141-8000_0d5962f6-76e3-48f6-953e-60e2a3422692 51141-8000 HUMAN OTC DRUG PSORIAPALM Non-Greasy Psoriasis SALICYLIC ACID LOTION TOPICAL 20120704 OTC MONOGRAPH FINAL part358H Neopharm Co., Ltd SALICYLIC ACID 2 mL/100mL E 20171231 51143-002_cf6a5515-8219-4a1e-a979-7355764f5b53 51143-002 HUMAN OTC DRUG Live Better Antifungal Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C The Great Atlantic & Pacific Tea Company CLOTRIMAZOLE 10 mg/g N 20181231 51143-004_d1ea75ce-a6aa-47f8-bb70-41a84c9548c9 51143-004 HUMAN OTC DRUG Fluoride Rinse for Kids SODIUM FLUORIDE RINSE ORAL 20090908 OTC MONOGRAPH FINAL part355 The Great Atlantic + Pacific Tea Company SODIUM FLUORIDE .05 kg/100L N 20181231 51143-016_68e38274-620e-4208-bb24-9e0cf9d6350d 51143-016 HUMAN OTC DRUG Live Better Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B The Great Atlantic & Pacific Tea Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 51143-027_668f2236-2b77-4460-992a-8f37281fa18e 51143-027 HUMAN OTC DRUG Live Better Triple Antibiotic plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B The Great Atlantic & Pacific Tea Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 51143-053_a3143a69-62b2-40e2-98fd-86666cc9b525 51143-053 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LIQUID TOPICAL 19991218 OTC MONOGRAPH NOT FINAL part333E The Great Atlantic + Pacific Tea Company ALCOHOL 62 kg/100L N 20181231 51143-059_39364dbe-6c30-4a18-8755-747f224fea5d 51143-059 HUMAN OTC DRUG Live Better Hydrocortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 The Great Atlantic & Pacific Tea Company HYDROCORTISONE 1 g/100g N 20181231 51143-066_260f9fef-5e12-4235-ad27-c9d24f7e90d8 51143-066 HUMAN OTC DRUG Live Better Anti-Itch Diphenhydramine hydrochloride and Zinc acetate CREAM TOPICAL 20050920 OTC MONOGRAPH FINAL part348 The Great Atlantic & Pacific Tea Company DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 51143-069_dd86e483-0aba-4556-bbad-6f74f22e5cbb 51143-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20091014 OTC MONOGRAPH FINAL part347 Onpoint, Inc PETROLATUM 1 g/g N 20181231 51143-072_9697dc71-57dc-46d9-a474-ff5a2d154d85 51143-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 20090727 OTC MONOGRAPH NOT FINAL part348 Onpoint, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 51143-075_25047950-6d46-494d-b913-e7e1282a50cc 51143-075 HUMAN OTC DRUG Live Better Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B The Great Atlantic & Pacific Tea Company BACITRACIN ZINC 500 [iU]/g N 20181231 51143-076_6f29b07f-7ffe-4a75-8ba9-88964b688111 51143-076 HUMAN OTC DRUG LiveBetter Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B The Great Atlantic & Pacific Tea Company NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 51143-080_5815e784-340a-4dd5-ad4b-473b8218a257 51143-080 HUMAN OTC DRUG Live Better Antifungal Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 The Great Atlantic & Pacific Tea Company TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 51143-092_f2e73f4c-202e-41bc-8d51-72fdad9273ab 51143-092 HUMAN OTC DRUG Live Better Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 The Great Atlantic & Pacific Tea Company LORATADINE 5 mg/5mL N 20181231 51143-124_d8bbf47e-25bc-4d45-86f4-7ab113bbb878 51143-124 HUMAN OTC DRUG Antispetic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20100716 OTC MONOGRAPH NOT FINAL part348 Onpoint, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 51143-153_bc6afced-2ce8-47ba-8d9f-b7966a258a6c 51143-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H On-Point, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 51143-163_d925c0fa-3a50-48c3-9c40-a14b335509de 51143-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20100716 OTC MONOGRAPH FINAL part355 Onpoint, Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 51143-203_24e11b1f-1102-405a-955e-272de7fad43b 51143-203 HUMAN OTC DRUG Waterless Hand Sanitizer Alcohol GEL TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A Onpoinr, Inc ALCOHOL .65 mL/100L N 20181231 51143-210_31651900-c5ae-4827-a592-8ad685d25dc2 51143-210 HUMAN OTC DRUG Antiseptic Eucalyptol MOUTHWASH ORAL 20101019 OTC MONOGRAPH NOT FINAL part356 Onpoint, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L N 20181231 51143-213_0ad88aff-7c4f-4dff-992b-eac787bdce42 51143-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20101112 OTC MONOGRAPH FINAL part355 The Great Atlantic + Pacific Tea Company SODIUM FLUORIDE .05 kg/100L N 20181231 51143-279_c58a272a-7b2e-4323-9180-29d1e74f9411 51143-279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part333A Onpoint, Inc BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 51143-281_020be78e-3d9c-41ed-982c-f3b0189be1c2 51143-281 HUMAN OTC DRUG Dry Scalp Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20120702 OTC MONOGRAPH FINAL part358H OnPoint, Inc PYRITHIONE ZINC 1 kg/100L N 20181231 51143-296_5154d236-cc4a-4d6f-be00-ed178de9298d 51143-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 19980304 OTC MONOGRAPH FINAL part358H OnPoint, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 51143-299_693d52a3-6fd9-4b58-b3bc-9966f529b24b 51143-299 HUMAN OTC DRUG Antiseptic Cetylpyridinium chloride MOUTHWASH ORAL 20100727 OTC MONOGRAPH NOT FINAL part356 Onpoint, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 51143-311_c7cc3028-dbd3-48bb-957e-a8ca712b53f2 51143-311 HUMAN OTC DRUG Everyday Clean Pyrithione Zinc SHAMPOO TOPICAL 20010103 OTC MONOGRAPH FINAL part358H OnPoint, Inc. PYRITHIONE ZINC 1 g/100mL N 20181231 51143-318_7baa33c2-74b0-478a-8613-b6b9413c6dc3 51143-318 HUMAN OTC DRUG Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20090727 OTC MONOGRAPH NOT FINAL part356 Onpoint, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 51143-370_adc294ef-e0a3-437e-96e1-169b1b11cf09 51143-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20140928 OTC MONOGRAPH NOT FINAL part333A Onpoint, Inc ALCOHOL 70 mL/100mL N 20181231 51143-403_58237791-df3f-4208-b44c-529eb1015669 51143-403 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333A Onpoint, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 51143-434_3ef57ef8-2eba-46db-9909-631130e76e5a 51143-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130613 OTC MONOGRAPH NOT FINAL part356 Onpoint, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 51143-435_d237398c-6315-470c-a32c-2a3bd39fdb0a 51143-435 HUMAN OTC DRUG Glowing White Sodium fluoride MOUTHWASH ORAL 20150729 OTC MONOGRAPH FINAL part355 Onpoint, Inc SODIUM FLUORIDE .2 mg/mL N 20181231 51143-439_05a6874b-a4ec-4744-8ab2-5021a970c248 51143-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140930 OTC MONOGRAPH NOT FINAL part333A Onpoint, Inc. ALCOHOL 700 mg/mL N 20181231 51143-541_1412fee9-1ac0-472d-868c-542a1db339b8 51143-541 HUMAN OTC DRUG Antibacterial Liquid Hand TRICLOSAN LIQUID TOPICAL 20090730 OTC MONOGRAPH NOT FINAL part333A OnPoint, Inc TRICLOSAN .115 kg/100L N 20181231 51143-545_c901099d-e225-4f32-aa90-d66dc019afbf 51143-545 HUMAN OTC DRUG Waterless Hand Sanitizer ALCOHOL GEL TOPICAL 20090109 OTC MONOGRAPH NOT FINAL part333A ONPOINT, INC ALCOHOL .62 kg/100L N 20181231 51143-619_05477f45-4beb-4c10-9bf3-0eeea55e709a 51143-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20110222 OTC MONOGRAPH FINAL part347 OnPoint, Inc DIMETHICONE 13.13 mg/mL N 20181231 51143-693_e9cfea1f-c2bb-443a-8b66-2afe15e76194 51143-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20090625 OTC MONOGRAPH NOT FINAL part334 OnPoint, Inc MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 51143-871_42a904ac-e14c-41e4-bb95-c10d35997330 51143-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19960320 OTC MONOGRAPH NOT FINAL part333A The Great Atlantic + Pacific Tea Company HYDROGEN PEROXIDE .3 kg/100L N 20181231 51143-951_20d57e51-71b8-4d06-b3b9-0779561c2723 51143-951 HUMAN OTC DRUG Instant Hand sanitizer ALCOHOL GEL TOPICAL 20110512 OTC MONOGRAPH NOT FINAL part333A Onpoint, Inc ALCOHOL 65 kg/100L N 20181231 51143-966_61ae85f9-238c-40bc-b2fc-bc335d78f3af 51143-966 HUMAN OTC DRUG Anticavity Sdoium Fluoride MOUTHWASH ORAL 20120321 OTC MONOGRAPH FINAL part355 Onpoint, Inc SODIUM FLUORIDE .0221 mL/100L N 20181231 51144-050_976af478-c489-43bc-86c8-adc5f0ea00ea 51144-050 HUMAN PRESCRIPTION DRUG ADCETRIS brentuximab vedotin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110825 BLA BLA125388 Seattle Genetics, Inc. BRENTUXIMAB VEDOTIN 50 mg/10.5mL CD30-directed Antibody Interactions [MoA],CD30-directed Immunoconjugate [EPC],Immunoconjugates [Chemical/Ingredient],Microtubule Inhibition [PE] N 20181231 51147-5010_14f39df9-e360-41ef-a046-da5c81c6cea1 51147-5010 HUMAN OTC DRUG Becca Mineral SPF Primer Zinc Oxide CREAM TOPICAL 20110412 OTC MONOGRAPH NOT FINAL part352 Becca, Inc. ZINC OXIDE 17 mL/100mL E 20171231 51150-066_c9091085-68a8-4ca4-ba79-8b1e9ee0da55 51150-066 HUMAN OTC DRUG Giorgio Armani Crema Nera OMC3 Obsidian Mineral Restoring Cream SPF 15 Avobenzone Octislate Octocrylene CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 Sicos Et Cie (Lancome) AVOBENZONE; OCTISALATE; OCTOCRYLENE 1; 2.5; 4 mL/50mL; mL/50mL; mL/50mL E 20171231 51150-409_cf3ca068-2f16-4e0f-8307-0ae7da14fe4f 51150-409 HUMAN OTC DRUG Yves Saint Laurent Teint Resist Long Wear Endless Comfort Transfer Resistant Foundation SPF 10 Titanium Dioxide LOTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Sicos Et Cie (Lancome) TITANIUM DIOXIDE 1.809 mL/30mL N 20181231 51150-661_7bba2dbb-3d67-4f12-b8d9-30ba92518a9b 51150-661 HUMAN OTC DRUG Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 20 Sunscreen Octinoxate and Titanium Dioxide LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 SICOS ET CIE OCTINOXATE; TITANIUM DIOXIDE 75; 31 mg/mL; mg/mL N 20181231 51151-000_48bcfd05-5b1e-5c0b-e054-00144ff8d46c 51151-000 HUMAN OTC DRUG CIDACIN Antifungal Treatment TOLNAFTATE SOLUTION TOPICAL 20120607 OTC MONOGRAPH FINAL part333C Pedicis Research LLC TOLNAFTATE 1 g/100mL N 20181231 51151-738_48a74e28-1c2e-61a5-e054-00144ff8d46c 51151-738 HUMAN OTC DRUG Planticin Advanced Topical Pain Relief LIDOCAINE CREAM TOPICAL 20160421 OTC MONOGRAPH NOT FINAL part348 Pedicis Research, LLC LIDOCAINE 40 mg/g N 20181231 51167-200_5a4c0e36-b291-4bec-862d-7e34077cba61 51167-200 HUMAN PRESCRIPTION DRUG Kalydeco ivacaftor TABLET, FILM COATED ORAL 20120131 NDA NDA203188 Vertex Pharmaceuticals Incorporated IVACAFTOR 150 mg/1 Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC],Chloride Channel Activation Potentiators [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 51167-300_5a4c0e36-b291-4bec-862d-7e34077cba61 51167-300 HUMAN PRESCRIPTION DRUG Kalydeco ivacaftor GRANULE ORAL 20150323 NDA NDA207925 Vertex Pharmaceuticals Incorporated IVACAFTOR 50 mg/1 Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC],Chloride Channel Activation Potentiators [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 51167-400_5a4c0e36-b291-4bec-862d-7e34077cba61 51167-400 HUMAN PRESCRIPTION DRUG Kalydeco ivacaftor GRANULE ORAL 20150323 NDA NDA207925 Vertex Pharmaceuticals Incorporated IVACAFTOR 75 mg/1 Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC],Chloride Channel Activation Potentiators [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 51167-700_eea7d8bd-aefc-48dd-95d2-17a35c6dd6fc 51167-700 HUMAN PRESCRIPTION DRUG ORKAMBI lumacaftor and ivacaftor TABLET, FILM COATED ORAL 20161003 NDA NDA206038 Vertex Pharmaceuticals Incorporated LUMACAFTOR; IVACAFTOR 100; 125 mg/1; mg/1 Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC],Chloride Channel Activation Potentiators [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC],Chloride Channel Activation Potentiators [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20191231 51167-809_eea7d8bd-aefc-48dd-95d2-17a35c6dd6fc 51167-809 HUMAN PRESCRIPTION DRUG ORKAMBI lumacaftor and ivacaftor TABLET, FILM COATED ORAL 20150706 NDA NDA206038 Vertex Pharmaceuticals Incorporated LUMACAFTOR; IVACAFTOR 200; 125 mg/1; mg/1 Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC],Chloride Channel Activation Potentiators [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC],Chloride Channel Activation Potentiators [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20191231 51191-2046_1c20e33a-261f-4d9f-ac88-63191d09ec7c 51191-2046 HUMAN OTC DRUG SPF 20 UVA/UVB HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part352 MULTALER ET CIE S.A.S. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 10; 7.5; 5; 5; 3; 2.7 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20191231 51191-3015_7fb90efb-4477-44de-a721-865fd5d0f7b4 51191-3015 HUMAN OTC DRUG SPF 50 UVA/UVB ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part352 MULTALER ET CIE S.A.S. OCTOCRYLENE; OXYBENZONE; AVOBENZONE; ENSULIZOLE 8; 5; 3; 3 g/100g; g/100g; g/100g; g/100g N 20191231 51191-3016_82bf79a1-0c3b-4057-b2fa-5851311d872b 51191-3016 HUMAN OTC DRUG SPF 25 UVA/UVB ENSULIZOLE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part352 MULTALER ET CIE S.A.S. OCTOCRYLENE; OXYBENZONE; AVOBENZONE; ENSULIZOLE 6; 5; 3; 3 g/100g; g/100g; g/100g; g/100g N 20191231 51198-001_87b93f2e-21ab-420a-bb40-fce5adaa8387 51198-001 HUMAN OTC DRUG VEHICLE BOAT BAG MEDICAL CHLOROXYLENOL CLOTH TOPICAL 20100923 OTC MONOGRAPH NOT FINAL part333E JBC CORP CHLOROXYLENOL .5 g/100g E 20171231 51201-100_dcd3becb-3622-4e88-a2f0-596f2d72fcd2 51201-100 HUMAN OTC DRUG MINI HAND SANITIZER - ORANGE AND LEMON ALCOHOL LIQUID TOPICAL 20100725 OTC MONOGRAPH FINAL part333 Goldessence, Limited ALCOHOL 62 mL/100mL E 20171231 51201-101_0697a512-4f54-4795-8f86-dbf7db5a5d03 51201-101 HUMAN OTC DRUG MINI HAND SANITIZER - COCONUT AND LIME ALCOHOL LIQUID TOPICAL 20100725 OTC MONOGRAPH FINAL part333 Goldessence, Limited ALCOHOL 62 mL/100mL E 20171231 51201-200_2f0de399-291f-404a-9e95-5f2bad98535d 51201-200 HUMAN OTC DRUG COCONUT LIME ANTIBACTERIAL SANITIZER ALCOHOL LIQUID TOPICAL 20100725 OTC MONOGRAPH FINAL part333 Goldessence, Limited ALCOHOL 62 mL/100mL E 20171231 51201-201_a0fd97d6-5b73-4581-8842-da2293c790be 51201-201 HUMAN OTC DRUG CUCUMBER MELON ANTIBACTERIAL SANITIZER ALCOHOL LIQUID TOPICAL 20100725 OTC MONOGRAPH FINAL part333 Goldessence, Limited ALCOHOL 62 mL/100mL E 20171231 51201-202_d7343886-a215-4690-9610-f4389b2d285d 51201-202 HUMAN OTC DRUG JASMINE AND GREEN TEA ANTIBACTERIAL SANITIZER ALCOHOL LIQUID TOPICAL 20100725 OTC MONOGRAPH FINAL part333 Goldessence, Limited ALCOHOL 62 mL/100mL E 20171231 51201-203_91d45b14-d2ee-4114-a7de-01acce045d70 51201-203 HUMAN OTC DRUG MANDARIN ORANGE AND LEMON ANTIBACTERIAL SANITIZER ALCOHOL LIQUID TOPICAL 20100725 OTC MONOGRAPH FINAL part333 Goldessence, Limited ALCOHOL 62 mL/100mL E 20171231 51206-201_e6e3201b-57b9-4053-85f4-622c8898f6c4 51206-201 HUMAN OTC DRUG Ultracare Anesthetic Bubble Gum Benzocaine GEL DENTAL 19860601 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc. BENZOCAINE 6.96 g/30mL N 20181231 51206-202_9ffc7c05-81d5-4d07-8690-dd400e2ab571 51206-202 HUMAN OTC DRUG Ultracare Anesthetic Walterberry Benzocaine GEL DENTAL 19930601 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc. BENZOCAINE 6.96 g/30mL N 20181231 51206-203_e3e16387-cdd1-43c9-bc45-352a5cb08d31 51206-203 HUMAN OTC DRUG Ultracare Anesthetic Butter Rum Benzocaine GEL DENTAL 19860601 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc. BENZOCAINE 6.96 g/30mL N 20181231 51206-204_9fe42dc7-2009-406a-9adc-286abb1a4020 51206-204 HUMAN OTC DRUG Ultracare Anesthetic Pina Colada Benzocaine GEL DENTAL 19860601 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc. BENZOCAINE 6.96 g/30mL N 20181231 51206-205_00beae87-6482-4afd-9fb0-2eb09cbad645 51206-205 HUMAN OTC DRUG Ultracare Anesthetic Creme de Menthe Benzocaine GEL DENTAL 19860601 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc. BENZOCAINE 6.96 g/30mL E 20171231 51206-206_c0a57368-8f37-4c3c-822a-bf4b24af8f06 51206-206 HUMAN OTC DRUG UltraCare Oral Anesthetic Orange Cream Benzocaine GEL DENTAL 20160601 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc BENZOCAINE 231 mg/mL N 20181231 51206-207_b53e4d09-108c-4b2c-a968-837a4d7265a0 51206-207 HUMAN OTC DRUG UltraCare Oral Anesthetic Cool Mint Benzocaine GEL DENTAL 20160601 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc BENZOCAINE 231 mg/mL N 20181231 51206-302_35da460e-d4d8-493b-bf04-540a229ea371 51206-302 HUMAN OTC DRUG Opalescence Whitening Toothpaste Sodium Fluoride GEL, DENTIFRICE DENTAL 19940701 OTC MONOGRAPH FINAL part355 Ultradent Products, Inc. SODIUM FLUORIDE .070875 g/28.35g E 20171231 51206-303_cf9374d9-3fe6-456f-b447-b66386decefb 51206-303 HUMAN OTC DRUG Opalescence PF Sodium Fluoride and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20101115 OTC MONOGRAPH FINAL part355 Ultradent Products, Inc. SODIUM FLUORIDE; POTASSIUM NITRATE .070875; 1.4175 g/28.35g; g/28.35g E 20171231 51206-308_45c1c632-30ea-4797-ae47-9e987250543e 51206-308 HUMAN OTC DRUG Opalescence Sensitivity Relief Whitening Potassium Nitrate and Sodium Fluoride GEL, DENTIFRICE DENTAL 20151130 OTC MONOGRAPH NOT FINAL part356 Ultradent Products, Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 50; 2.5 mg/g; mg/g N 20181231 51206-401_d31c7e87-bcdf-487d-bb25-a841678dc35e 51206-401 HUMAN PRESCRIPTION DRUG Flor-Opal Sustained-Release Fluoride Sodium Fluoride GEL DENTAL 19900531 UNAPPROVED DRUG OTHER Ultradent Products, Inc SODIUM FLUORIDE 5 mg/mL N 20181231 51208-001_b48aa843-fafd-4f15-aa0e-c5ac9f25fc6c 51208-001 HUMAN OTC DRUG Pain and Fever Relief Childrens Strength Acetaminophen TABLET, CHEWABLE ORAL 20140318 OTC MONOGRAPH NOT FINAL part343 ScripsAmerica ACETAMINOPHEN 80 mg/1 N 20181231 51208-002_5f5af556-2c42-4d4b-8f26-5b549db22fd6 51208-002 HUMAN OTC DRUG Pain and Fever Relief Childrens Strength, Wild Grape Flavor Acetaminophen TABLET, CHEWABLE ORAL 20041206 OTC MONOGRAPH NOT FINAL part343 ScripsAmerica ACETAMINOPHEN 80 mg/1 N 20181231 51208-003_c5e644d3-b1bc-486c-8cf9-9fd0fbfd44e5 51208-003 HUMAN OTC DRUG Pain and Fever Relief Junior Strength Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 ScripsAmerica ACETAMINOPHEN 160 mg/1 N 20181231 51208-004_eba9a938-bf82-404f-8cd6-b9f8897f0ddb 51208-004 HUMAN OTC DRUG Pain and Fever Relief Junior Strength/Wild Grape Flavor Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 ScripsAmerica ACETAMINOPHEN 160 mg/1 N 20181231 51209-001_cfe6b69f-842d-44ae-a11c-d34ff20de7a8 51209-001 HUMAN OTC DRUG dalan Therapy ANTIBACTERIAL and odor neutralizer TRICLOSAN LIQUID TOPICAL 20140806 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN 1 mg/mL E 20171231 51209-002_803c1bef-3092-4356-8f50-031d02128c71 51209-002 HUMAN OTC DRUG dalan GOLDEN TROPICS antibacterial deodorant TRICLOSAN SOAP TOPICAL 20140806 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN .1 g/100g E 20171231 51209-003_009b308f-4e2b-4b83-9069-6940f8adb21f 51209-003 HUMAN OTC DRUG dalan OCEAN BREEZE antibacterial deodorant TRICLOSAN SOAP TOPICAL 20140806 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN .1 g/100g E 20171231 51209-004_401e3d81-e68a-4670-a425-bb26def4bc34 51209-004 HUMAN OTC DRUG dalan Spring Freshness antibacterial deodorant TRICLOSAN SOAP TOPICAL 20140806 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN .1 g/100g E 20171231 51209-005_2b9b0d78-b28f-59ef-e054-00144ff8d46c 51209-005 HUMAN OTC DRUG dalan ANTIBACTERIAL deodorant Ocean Breeze regenerating TRICLOSAN SOAP TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN .1 g/100g E 20171231 51209-006_2b9b0d78-b28c-59ef-e054-00144ff8d46c 51209-006 HUMAN OTC DRUG Dalan Covex Antibacterial Deodorant Natural Hygiene TRICLOSAN SOAP TOPICAL 20160128 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN 1 mg/g E 20171231 51209-007_2b9b0d78-b28b-59ef-e054-00144ff8d46c 51209-007 HUMAN OTC DRUG Dalan Covex Antibacterial Deodorant Soft Hygiene TRICLOSAN SOAP TOPICAL 20160128 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN 1 mg/g E 20171231 51209-008_2b9b0d78-b28d-59ef-e054-00144ff8d46c 51209-008 HUMAN OTC DRUG Dalan Covex Antibacterial Deodorant Maximum Hygiene TRICLOSAN SOAP TOPICAL 20160128 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN 1 mg/g E 20171231 51209-009_2b9a9d99-7164-3cee-e054-00144ff88e88 51209-009 HUMAN OTC DRUG Dalan Antibacterial Deodorant Spring Freshness TRICLOSAN SOAP TOPICAL 20160205 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN 1 mg/g E 20171231 51209-010_2b9b0d78-b289-59ef-e054-00144ff8d46c 51209-010 HUMAN OTC DRUG Dalan Antibacterial Deodorant Ocean Breeze TRICLOSAN SOAP TOPICAL 20160205 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN 1 mg/g E 20171231 51209-011_2b9b0d78-b28a-59ef-e054-00144ff8d46c 51209-011 HUMAN OTC DRUG Dalan Antibacterial Deodorant Golden Tropics TRICLOSAN SOAP TOPICAL 20160205 OTC MONOGRAPH NOT FINAL part333E Dalan Kimya Endustri A.S. TRICLOSAN 1 mg/g E 20171231 51220-1001_b4dbd597-f3e4-4817-9ed2-93990eb89a63 51220-1001 HUMAN OTC DRUG Fresh Morning Bifidus bifidus lactobacillus POWDER ORAL 20100821 UNAPPROVED DRUG OTHER Saimdang Cosmetics Co., Ltd LACTIC ACID .0316 mg/mg E 20171231 51220-2001_80171c6e-b6b6-4436-a3bf-5ef28d3d2d52 51220-2001 HUMAN OTC DRUG Multi Vitamin and Mineral vitamin ascorbic TABLET, CHEWABLE ORAL 20100821 UNAPPROVED DRUG OTHER Saimdang Cosmetics Co., Ltd ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, D-; NIACINAMIDE; ZINC OXIDE; VITAMIN A; CALCIUM PANTOTHENATE; MANGANESE; MANGANESE; PYRIDOXINE; THIAMINE; RIBOFLAVIN; FOLIC ACID 35; 10; 7.5; 4.3; 3.5; 1.5; 1.2; .76; .4; .36; .3; .1 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 E 20171231 51220-3001_f5947cf3-6d68-4e42-bc24-b99ecbc5d0f6 51220-3001 HUMAN OTC DRUG Pure Calcium calcium calcium TABLET, CHEWABLE ORAL 20100824 UNAPPROVED DRUG OTHER Saimdang Cosmetics Co., Ltd CALCIUM; MANGANESE; CHOLECALCIFEROL 435; 1.7; 1.2 mg/1; mg/1; mg/1 E 20171231 51220-4001_82c2d9cd-e7ab-4603-959e-c3435b479210 51220-4001 HUMAN OTC DRUG Cheon Shim Bo Yun N-ACETYLGLUCOSAMINE CAPSULE ORAL 20101108 UNAPPROVED DRUG OTHER Saimdang Cosmetics Co., Ltd N-ACETYLGLUCOSAMINE; .ALPHA.-TOCOPHEROL ACETATE, D-; SOY ISOFLAVONES 263; 3; 30 mg/1; mg/1; mg/1 E 20171231 51220-5001_6b444347-e6ec-491a-b404-b786989ba4fc 51220-5001 HUMAN OTC DRUG Cheon Shim Bo Hwa borage oil CAPSULE ORAL 20110406 UNAPPROVED DRUG OTHER Saimdang Cosmetics Co., Ltd BORAGE OIL; .ALPHA.-TOCOPHEROL ACETATE, D- 311; 1 mg/1; mg/1 E 20171231 51224-001_5892443a-3163-7ab3-e053-2991aa0a9e93 51224-001 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20150810 ANDA ANDA202765 TAGI Pharma, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 51224-007_7c8d44a1-59ab-4bd7-a759-7cced0ca7c4c 51224-007 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080417 ANDA ANDA078321 TAGI Pharma, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51224-010_5892443a-3163-7ab3-e053-2991aa0a9e93 51224-010 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20170907 ANDA ANDA202765 TAGI Pharma, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 51224-101_7c9c0823-3453-497a-afcd-889e5f7302da 51224-101 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20110308 ANDA ANDA200272 TAGI Pharma, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 51224-102_c7f08168-a7d3-46ab-ac51-31946ee6205b 51224-102 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20120309 ANDA ANDA076723 TAGI Pharma, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 51224-107_7c8d44a1-59ab-4bd7-a759-7cced0ca7c4c 51224-107 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080417 ANDA ANDA078321 TAGI Pharma, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51224-151_4d389aa0-ee85-4fb9-b484-c90834778cf9 51224-151 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20110415 ANDA ANDA075517 TAGI Pharma, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 51224-153_fb7d0866-c5b6-40ac-ac3d-7903d40ac92b 51224-153 HUMAN OTC DRUG Aluminum Acetate Astringent Calcium Acetate and Aluminum sulfate POWDER, FOR SOLUTION TOPICAL 20110615 OTC MONOGRAPH FINAL part347 TAGI Pharma Incorporated CALCIUM ACETATE; ALUMINUM SULFATE 839; 1191 mg/2030mg; mg/2030mg N 20181231 51224-154_34c3850c-1be2-4a78-9339-b2647a94cc3a 51224-154 HUMAN PRESCRIPTION DRUG Flavoxate Hydrochloride Flavoxate hydrochloride TABLET, FILM COATED ORAL 20110325 ANDA ANDA076835 TAGI Pharma, Inc. FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 51224-162_3df1c75d-2a03-48b1-9943-4d6ca9929fa2 51224-162 HUMAN OTC DRUG Astringent Calcium acetate monohydrate and Aluminum sulfate tetradecahydrate POWDER, FOR SOLUTION TOPICAL 20120601 OTC MONOGRAPH FINAL part347 TAGI Pharma Inc. CALCIUM ACETATE MONOHYDRATE; ALUMINUM SULFATE TETRADECAHYDRATE 952; 1347 mg/2299mg; mg/2299mg N 20181231 51224-202_598f8ec6-dc15-4076-ab52-8f81c130fc0f 51224-202 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120217 ANDA ANDA202248 TAGI Pharma, Inc PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 51224-203_598f8ec6-dc15-4076-ab52-8f81c130fc0f 51224-203 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120217 ANDA ANDA202248 TAGI Pharma, Inc PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 51224-206_c6c4d7a8-0950-4b3c-905e-c8dab5a9f6dd 51224-206 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20130923 ANDA ANDA075274 TAGI Pharma Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 51224-301_02d159d3-9633-42b5-8f23-99207e61fb3a 51224-301 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium SOLUTION ORAL 20130225 ANDA ANDA090520 TAGI Pharma, Inc. ALENDRONATE SODIUM 70 mg/75mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 51224-400_d1cc9cba-9034-4c2d-84d4-22f5ab711329 51224-400 HUMAN OTC DRUG Benzoyl Peroxide Emollient Benzoyl Peroxide AEROSOL, FOAM TOPICAL 20131011 OTC MONOGRAPH FINAL part333D TAGI Pharma Inc. BENZOYL PEROXIDE 53 mg/g N 20181231 51224-401_c6712fba-c413-4aa6-b075-28190233cadf 51224-401 HUMAN OTC DRUG Benzoyl Peroxide Emollient Benzoyl Peroxide AEROSOL, FOAM TOPICAL 20131011 OTC MONOGRAPH FINAL part333D TAGI Pharma Inc. BENZOYL PEROXIDE 98 mg/g N 20181231 51224-425_6c0d281a-5882-4bcb-997c-6739b07c5e05 51224-425 HUMAN PRESCRIPTION DRUG Tetrabenazine Tetrabenazine TABLET ORAL 20170201 ANDA ANDA207682 TAGI Pharma, Inc. TETRABENAZINE 12.5 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20181231 51224-426_6c0d281a-5882-4bcb-997c-6739b07c5e05 51224-426 HUMAN PRESCRIPTION DRUG Tetrabenazine Tetrabenazine TABLET ORAL 20170201 ANDA ANDA207682 TAGI Pharma, Inc. TETRABENAZINE 25 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20181231 51230-391_52adf0e7-14dd-4833-a166-1a4afff4ff11 51230-391 HUMAN OTC DRUG NOXICARE .Alpha.-Lipoic Acid, Turmeric, Ocimum Tenuiflorum Top, Indian Frankincense, Rosemary, Salix Alba Bark, and Ginger CREAM TOPICAL 20120914 UNAPPROVED HOMEOPATHIC Truceuticals, LLC .ALPHA.-LIPOIC ACID; TURMERIC; OCIMUM TENUIFLORUM TOP; INDIAN FRANKINCENSE; ROSEMARY; SALIX ALBA BARK; GINGER 4; 4; 4; 4; 4; 4; 4 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 51230-418_65a2b1c2-7a19-4df2-8695-5b5c54983d65 51230-418 HUMAN OTC DRUG Tru-micin Trolamine LOTION TOPICAL 20130607 OTC MONOGRAPH NOT FINAL part348 Truceuticals, LLC TROLAMINE .1 mg/mL E 20171231 51230-824_ddafa3ab-c669-4a06-87be-0d31f16d6ce4 51230-824 HUMAN OTC DRUG NOXICARE Natural Pain Relief .Alpha.-Lipoic Acid, Turmeric, Ocimum Tenuiflorum Top, Indian Frankincense, Rosemary, Salix Alba Bark, and Ginger CAPSULE ORAL 20120914 UNAPPROVED HOMEOPATHIC Truceuticals, LLC .ALPHA.-LIPOIC ACID; TURMERIC; OCIMUM TENUIFLORUM TOP; INDIAN FRANKINCENSE; ROSEMARY; SALIX ALBA BARK; GINGER 1; 1; 1; 1; 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 51239-0929_8b15acec-ee51-43ae-8362-b58ec11156b4 51239-0929 HUMAN OTC DRUG SCRUBS Lemon Hand Sanitizer Wipes SCRUBS Hand Sanitizer Wipes CLOTH TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 ITW Dymon BENZALKONIUM CHLORIDE; BENZETHONIUM CHLORIDE .1; .1 g/970mL; g/970mL E 20171231 51239-1929_5eb2636c-513f-4fdb-9ea4-8ca7270041a0 51239-1929 HUMAN OTC DRUG SCRUBS Foaming Hand Sanitizer SCRUBS Hand Sanitizer Foam SOLUTION TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 ITW Dymon BENZETHONIUM CHLORIDE; BENZALKONIUM CHLORIDE .1; .1 g/970mL; g/970mL E 20171231 51248-150_8b3031ca-3676-499a-ac82-53fc20116aa5 51248-150 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Astellas Pharma US, Inc. SOLIFENACIN SUCCINATE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 51248-151_8b3031ca-3676-499a-ac82-53fc20116aa5 51248-151 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Astellas Pharma US, Inc. SOLIFENACIN SUCCINATE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 51257-640_2bbb3e50-1128-47c2-bd24-1ef0097f04d3 51257-640 HUMAN OTC DRUG Tea Tree Antiseptic Melaleuca Alternifolia OIL TOPICAL 20110201 UNAPPROVED DRUG OTHER Integria Healthcare US Inc. TEA TREE OIL 15 mL/15mL E 20171231 51257-642_dee2c583-61d1-4b1c-955f-b9319b4e5df4 51257-642 HUMAN OTC DRUG Tea Tree Antiseptic Tea Tree Oil OINTMENT TOPICAL 20130827 UNAPPROVED DRUG OTHER Integria Healthcare (US) Inc TEA TREE OIL 50 mg/g E 20171231 51257-644_58bedeaa-78d7-4baa-9810-ea7be458dd3c 51257-644 HUMAN OTC DRUG Tea Tree Antiseptic Melaleuca Alternifolia OINTMENT TOPICAL 20110201 UNAPPROVED DRUG OTHER Integria Healthcare US Inc. TEA TREE OIL 2.5 g/50g E 20171231 51263-3125_4d8dd2ad-f84b-4f4b-92e5-01584491acea 51263-3125 HUMAN OTC DRUG Vanilla Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL E 20171231 51263-3126_20c43fc8-02ce-4f5a-a9e0-e5f45d93a26a 51263-3126 HUMAN OTC DRUG Unscented Hand Sanitizer ALCOHOL LIQUID TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL E 20171231 51263-3183_054821b8-3112-4e8e-b72c-84d774df34dc 51263-3183 HUMAN OTC DRUG Sweet Berry Hand Sanitizer Alcohol GEL TOPICAL 20121017 OTC MONOGRAPH FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL N 20181231 51263-3184_e2fb5f5b-8051-46df-a689-3967103e927d 51263-3184 HUMAN OTC DRUG Berry Hand Sanitizer with vitamin E and aloe ALCOHOL LIQUID TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL N 20181231 51263-3185_d61c532e-7b3c-4824-88c1-90e137bcf800 51263-3185 HUMAN OTC DRUG Citrus Hand Sanitizer with vitamin E and aloe ALCOHOL LIQUID TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL N 20181231 51263-3186_66a0c859-bfb5-467b-92b6-e7bc3223619a 51263-3186 HUMAN OTC DRUG Fresh Hand Sanitizer with vitamin E and aloe ALCOHOL LIQUID TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL N 20181231 51263-3187_27f80690-b4eb-4e2f-afff-3aecf0758aaa 51263-3187 HUMAN OTC DRUG Vanilla Hand Sanitizer with vitamin E and aloe ALCOHOL LIQUID TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part333E MGS Group Limited ALCOHOL 62 mL/100mL N 20181231 51264-0001_d3d0f37e-be93-4047-8e5a-5d883891e5bf 51264-0001 HUMAN OTC DRUG Healthy Weight Formula Asclepias Vincetoxicum, Echinachea, Hypothalamus, Brain, Hepar Suis, Methylcobalamin, Pancreas Suis, Renal, Stomach(Suis), AACG-A, AACG-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto DHEA, ATP, Glucagon, Insulin, Sarcolacticum Acidum, Proteus Bach LIQUID ORAL 20130222 UNAPPROVED HOMEOPATHIC Healing Power Within Inc. CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; METHYLCOBALAMIN; SUS SCROFA PANCREAS; PORK KIDNEY; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-OXO-PRASTERONE; ADENOSINE TRIPHOSPHATE; GLUCAGON; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 51267-890_49cd5e96-8258-4fbb-a471-4985ae541b5a 51267-890 HUMAN PRESCRIPTION DRUG Contrave Extended-Release naltrexone hydrochloride and bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20141022 NDA NDA200063 Orexigen Therapeutics, Inc. NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE 8; 90 mg/1; mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA],Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 51270-111_59fa7f73-ed18-4343-a4b3-ef9463cf12b6 51270-111 HUMAN OTC DRUG Hesol Rim SALICYLIC ACID GEL TOPICAL 20101001 UNAPPROVED DRUG OTHER Ecomine Co Ltd SALICYLIC ACID; NIACINAMIDE .3; .6 mL/300mL; mL/300mL E 20171231 51270-112_027f99c0-4475-41a9-8df0-45d6441e98c3 51270-112 HUMAN OTC DRUG Hesol Rim Tonic SALICYLIC ACID LIQUID TOPICAL 20101001 UNAPPROVED DRUG OTHER Ecomine Co Ltd SALICYLIC ACID; NIACINAMIDE .3; .3 mL/100mL; mL/100mL E 20171231 51270-113_8f452f90-0479-4dbd-bba7-8a17e02df33f 51270-113 HUMAN OTC DRUG Hesol Rim Jean-Aeck Hair tonic SALICYLIC ACID LIQUID TOPICAL 20101001 UNAPPROVED DRUG OTHER Ecomine Co Ltd SALICYLIC ACID; NIACINAMIDE .5; .3 mL/100mL; mL/100mL E 20171231 51270-114_663071d3-f615-464a-be61-11bf938d6655 51270-114 HUMAN OTC DRUG Hasol Revitalizing DIMETHICONE GEL TOPICAL 20130701 OTC MONOGRAPH FINAL part347 Ecomine Co Ltd DIMETHICONE 2 g/300g E 20171231 51270-115_eb3dc411-de86-4805-91ce-5e1f379cc0e9 51270-115 HUMAN OTC DRUG Hasol Revitalizing Treatment DIMETHICONE GEL TOPICAL 20130701 OTC MONOGRAPH FINAL part347 Ecomine Co Ltd DIMETHICONE 1 g/300g E 20171231 51270-116_cc5615fc-e259-4216-97ce-64454a5df4b8 51270-116 HUMAN OTC DRUG Hasol Revitalizing Scalp Ampoule ALLANTOIN LIQUID TOPICAL 20130701 OTC MONOGRAPH FINAL part347 Ecomine Co Ltd ALLANTOIN .1 g/10g E 20171231 51270-117_ea9f7f74-d850-48e7-aba1-8e9f9cc305bc 51270-117 HUMAN OTC DRUG Hasol Anti hair loss day tonic Salicylic Acid,Niacinamide LIQUID TOPICAL 20140501 UNAPPROVED DRUG OTHER Ecomine Co., Ltd. SALICYLIC ACID; NIACINAMIDE .375; .225 g/75g; g/75g E 20171231 51270-118_835404f5-749c-46b7-9486-cb451d9d9d6a 51270-118 HUMAN OTC DRUG denovo 3 H Salicylic Acid,Niacinamide LIQUID TOPICAL 20140501 UNAPPROVED DRUG OTHER Ecomine Co., Ltd. SALICYLIC ACID; NIACINAMIDE .225; .225 g/75g; g/75g E 20171231 51270-119_64131e37-5f74-444e-8701-656749c4f904 51270-119 HUMAN OTC DRUG HASOL Intensive Salicylic Acid SHAMPOO TOPICAL 20140820 OTC MONOGRAPH FINAL part358H Ecomine Co., Ltd. SALICYLIC ACID .1 1/300mL E 20171231 51270-120_963df524-a67b-4c57-b310-2d36c9b43e40 51270-120 HUMAN OTC DRUG HASOL Intensive Scalp Tonic Salicylic Acid, Niacinamide, Menthol LIQUID TOPICAL 20140820 UNAPPROVED DRUG OTHER ECOMINE Co., Ltd. SALICYLIC ACID; NIACINAMIDE; MENTHOL .3; .3; .3 1/100mL; 1/100mL; 1/100mL E 20171231 51270-121_1e6fec35-b789-486e-87d1-41a428cd8c7c 51270-121 HUMAN OTC DRUG Hasol Anti Hair loss day tonic salicylic acid, niacinamide SPRAY TOPICAL 20140727 UNAPPROVED DRUG OTHER Ecomine Co., Ltd. SALICYLIC ACID; NIACINAMIDE .5; .3 1/100mL; 1/100mL E 20171231 51270-122_89756715-c585-46ae-bbd1-45439341021b 51270-122 HUMAN OTC DRUG HASOL Anagen Hair Tonic Dexpanthenol, Menthol, Salicylic Acid LIQUID TOPICAL 20160328 UNAPPROVED DRUG OTHER ECOMINE Co., Ltd. DEXPANTHENOL; MENTHOL; SALICYLIC ACID .002; .003; .0025 1/100mL; 1/100mL; 1/100mL E 20171231 51270-123_1e49ea9a-87ab-4513-a23c-dbec6158bc68 51270-123 HUMAN OTC DRUG HASOL Anagen Scalp Menthol, Salicylic Acid, Dexpanthenol SHAMPOO TOPICAL 20160328 UNAPPROVED DRUG OTHER ECOMINE Co., Ltd. MENTHOL; SALICYLIC ACID; DEXPANTHENOL .003; .0025; .002 1/500g; 1/500g; 1/500g E 20171231 51270-124_b9464496-af33-4f6c-819b-50ea4dab2210 51270-124 HUMAN OTC DRUG HASOL Anti Hair Loss Dexpanthenol, Menthol, Salicylic Acid SHAMPOO TOPICAL 20160331 UNAPPROVED DRUG OTHER ECOMINE Co., Ltd. DEXPANTHENOL; MENTHOL; SALICYLIC ACID .002; .003; .0025 1/500g; 1/500g; 1/500g E 20171231 51270-125_ab7c0060-722b-458e-9d5a-ed2717c6352d 51270-125 HUMAN OTC DRUG HASOL Vital For Hair-Loss Tonic Dexpanthenol, Menthol, Salicylic Acid LIQUID TOPICAL 20160401 UNAPPROVED DRUG OTHER ECOMINE Co., Ltd. DEXPANTHENOL; MENTHOL; SALICYLIC ACID .002; .003; .0025 1/100mL; 1/100mL; 1/100mL E 20171231 51285-040_29f71ed0-65d0-4d39-a8e7-e400a4913ab0 51285-040 HUMAN PRESCRIPTION DRUG Ziac bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 19931026 NDA NDA020186 Teva Women's Health, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51285-047_29f71ed0-65d0-4d39-a8e7-e400a4913ab0 51285-047 HUMAN PRESCRIPTION DRUG Ziac bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 19931026 NDA NDA020186 Teva Women's Health, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51285-050_29f71ed0-65d0-4d39-a8e7-e400a4913ab0 51285-050 HUMAN PRESCRIPTION DRUG Ziac bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 19931026 NDA NDA020186 Teva Women's Health, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51285-063_942d45d3-c905-40a7-948e-4ec38f0cb484 51285-063 HUMAN PRESCRIPTION DRUG Prefest Estradiol/Norgestimate KIT 20060530 ANDA ANDA076812 Teva Women's Health, Inc. N 20181231 51285-087_bea10ee5-c133-48d2-9af9-1cb198214125 51285-087 HUMAN PRESCRIPTION DRUG Seasonique Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol KIT 20060710 NDA NDA021840 Teva Women's Health, Inc. N 20181231 51285-092_787820a5-ee10-4546-a905-6df46faadb51 51285-092 HUMAN PRESCRIPTION DRUG LoSeasonique Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20090323 NDA NDA022262 Teva Women's Health, Inc. N 20181231 51285-100_71143338-1789-45a8-bfbd-e1c73479bcd1 51285-100 HUMAN OTC DRUG Take Action Levonorgestrel TABLET ORAL 20140217 NDA AUTHORIZED GENERIC NDA021998 Teva Women's Health, Inc. LEVONORGESTREL 1.5 mg/1 N 20181231 51285-103_32066769-70e3-4822-bc57-ecbea3771a4e 51285-103 HUMAN OTC DRUG Aftera levonorgestrel TABLET ORAL 20141020 NDA AUTHORIZED GENERIC NDA021998 Teva Women's Health, Inc. LEVONORGESTREL 1.5 mg/1 N 20181231 51285-120_c4c9e9dc-7e2a-459a-93e5-e3347fb9b1ed 51285-120 HUMAN PRESCRIPTION DRUG Mircette Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20140915 ANDA ANDA075863 Teva Women's Health, Inc. N 20181231 51285-125_67cb0f53-2251-4e71-a9e2-1444b1b5a0e2 51285-125 HUMAN PRESCRIPTION DRUG Loestrin Fe 28 Day Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20150226 ANDA ANDA076081 Teva Women's Health, Inc. N 20181231 51285-126_67cb0f53-2251-4e71-a9e2-1444b1b5a0e2 51285-126 HUMAN PRESCRIPTION DRUG Loestrin Fe 28 Day Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20150722 ANDA ANDA076081 Teva Women's Health, Inc. N 20181231 51285-127_67cb0f53-2251-4e71-a9e2-1444b1b5a0e2 51285-127 HUMAN PRESCRIPTION DRUG Loestrin 21 Day Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20150226 ANDA ANDA076381 Teva Women's Health, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1.5; 30 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 51285-128_67cb0f53-2251-4e71-a9e2-1444b1b5a0e2 51285-128 HUMAN PRESCRIPTION DRUG Loestrin Fe 28 Day Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20150226 ANDA ANDA076064 Teva Women's Health, Inc. N 20181231 51285-129_67cb0f53-2251-4e71-a9e2-1444b1b5a0e2 51285-129 HUMAN PRESCRIPTION DRUG Loestrin Fe 28 Day Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20150729 ANDA ANDA076064 Teva Women's Health, Inc. N 20181231 51285-131_67cb0f53-2251-4e71-a9e2-1444b1b5a0e2 51285-131 HUMAN PRESCRIPTION DRUG Loestrin 21 Day Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20150226 ANDA ANDA076380 Teva Women's Health, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; 20 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 51285-138_ba8b4a76-7666-4708-8fcc-8cdb7ef1d19b 51285-138 VACCINE Adenovirus Type 4 and Type 7 Vaccine, Live Adenovirus Type 4 and Type 7 Vaccine, Live KIT 20110916 BLA BLA125296 Teva Women's Health, Inc. N 20181231 51285-146_a9f261fe-d10e-4ea0-aa74-531c099d0561 51285-146 HUMAN OTC DRUG Plan B One-Step Levonorgestrel TABLET ORAL 20131218 NDA NDA021998 Teva Women's Health, Inc. LEVONORGESTREL 1.5 mg/1 N 20181231 51285-162_a9f261fe-d10e-4ea0-aa74-531c099d0561 51285-162 HUMAN OTC DRUG Plan B One-Step Levonorgestrel TABLET ORAL 20130826 NDA NDA021998 Teva Women's Health, Inc. LEVONORGESTREL 1.5 mg/1 N 20181231 51285-204_0794f6c6-1f56-451c-bf45-f74b2e97ad91 51285-204 HUMAN PRESCRIPTION DRUG ParaGard T 380A Copper INTRAUTERINE DEVICE INTRAUTERINE 20040101 NDA NDA018680 Teva Women's Health, Inc. COPPER 313.4 mg/1 Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 51285-366_1c9f5c9c-87f1-4efb-b7bb-29181932f7d8 51285-366 HUMAN PRESCRIPTION DRUG Trexall Methotrexate TABLET, FILM COATED ORAL 20010503 ANDA ANDA040385 Teva Women's Health, Inc. METHOTREXATE SODIUM 5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 51285-367_1c9f5c9c-87f1-4efb-b7bb-29181932f7d8 51285-367 HUMAN PRESCRIPTION DRUG Trexall Methotrexate TABLET, FILM COATED ORAL 20010503 ANDA ANDA040385 Teva Women's Health, Inc. METHOTREXATE SODIUM 7.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 51285-368_1c9f5c9c-87f1-4efb-b7bb-29181932f7d8 51285-368 HUMAN PRESCRIPTION DRUG Trexall Methotrexate TABLET, FILM COATED ORAL 20010503 ANDA ANDA040385 Teva Women's Health, Inc. METHOTREXATE SODIUM 10 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 51285-369_1c9f5c9c-87f1-4efb-b7bb-29181932f7d8 51285-369 HUMAN PRESCRIPTION DRUG Trexall Methotrexate TABLET, FILM COATED ORAL 20010503 ANDA ANDA040385 Teva Women's Health, Inc. METHOTREXATE SODIUM 15 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 51285-424_0398ee6d-9693-48f2-b10a-794f8ce4074f 51285-424 HUMAN PRESCRIPTION DRUG Aygestin Norethindrone Acetate TABLET ORAL 20030612 ANDA ANDA075951 Teva Women's Health, Inc. NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 51285-431_ee49aaee-e443-43b0-ad5e-3afd5e02a3d2 51285-431 HUMAN PRESCRIPTION DRUG QUARTETTE Levonorgestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20130725 NDA NDA204061 Teva Women's Health, Inc. N 20181231 51285-523_d635d91c-e9c2-4525-b3be-8089c858c6d2 51285-523 HUMAN PRESCRIPTION DRUG Antabuse Disulfiram TABLET ORAL 20001201 ANDA ANDA088482 Teva Women's Health, Inc. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 51285-524_d635d91c-e9c2-4525-b3be-8089c858c6d2 51285-524 HUMAN PRESCRIPTION DRUG Antabuse Disulfiram TABLET ORAL 20060201 ANDA ANDA088483 Teva Women's Health, Inc. DISULFIRAM 500 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 51285-538_2cd02db6-835a-4795-852e-aa6e6d263124 51285-538 HUMAN PRESCRIPTION DRUG Surmontil Trimipramine Maleate CAPSULE ORAL 19900930 NDA NDA016792 Teva Women's Health, Inc. TRIMIPRAMINE MALEATE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51285-539_2cd02db6-835a-4795-852e-aa6e6d263124 51285-539 HUMAN PRESCRIPTION DRUG Surmontil Trimipramine Maleate CAPSULE ORAL 19900930 NDA NDA016792 Teva Women's Health, Inc. TRIMIPRAMINE MALEATE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51285-554_2cd02db6-835a-4795-852e-aa6e6d263124 51285-554 HUMAN PRESCRIPTION DRUG Surmontil Trimipramine Maleate CAPSULE ORAL 19900930 NDA NDA016792 Teva Women's Health, Inc. TRIMIPRAMINE MALEATE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51285-690_86c83f07-2865-4ee0-afb0-b4699e86d47a 51285-690 HUMAN PRESCRIPTION DRUG Urecholine Bethanechol Chloride TABLET ORAL 20010201 ANDA ANDA088440 Teva Women's Health, Inc. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 51285-691_86c83f07-2865-4ee0-afb0-b4699e86d47a 51285-691 HUMAN PRESCRIPTION DRUG Urecholine Bethanechol Chloride TABLET ORAL 20000401 ANDA ANDA088441 Teva Women's Health, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 51285-692_86c83f07-2865-4ee0-afb0-b4699e86d47a 51285-692 HUMAN PRESCRIPTION DRUG Urecholine Bethanechol Chloride TABLET ORAL 20010201 ANDA ANDA089096 Teva Women's Health, Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 51285-697_86c83f07-2865-4ee0-afb0-b4699e86d47a 51285-697 HUMAN PRESCRIPTION DRUG Urecholine Bethanechol Chloride TABLET ORAL 20010201 ANDA ANDA089095 Teva Women's Health, Inc. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 51285-754_2203cc2f-0fd6-46df-91e7-961eeb3bf02d 51285-754 HUMAN PRESCRIPTION DRUG Diamox Sequels Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20000222 NDA NDA012945 Teva Women's Health, Inc. ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 51289-100_728deb34-df4e-44f6-b9b7-4c4f4968ee40 51289-100 HUMAN OTC DRUG Rain Breeze Toothpaste SODIUM FLUORIDE PASTE DENTAL 20100821 OTC MONOGRAPH FINAL part355 Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. SODIUM FLUORIDE .22 g/100g E 20171231 51289-200_0bd50eca-83a5-4c15-95e7-460e07cd8779 51289-200 HUMAN OTC DRUG Charm Tex Fluoride SODIUM FLUORIDE PASTE DENTAL 20130710 OTC MONOGRAPH FINAL part355 Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 51289-300_307febb4-e869-4064-e054-00144ff88e88 51289-300 HUMAN OTC DRUG MintBlast Anti Cavity Fluoride Sodium Fluoride PASTE DENTAL 20160307 OTC MONOGRAPH NOT FINAL part356 Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd SODIUM FLUORIDE .243 g/100g E 20171231 51289-400_37083c7b-abe9-5cd6-e054-00144ff8d46c 51289-400 HUMAN OTC DRUG Fluoride Gel Sodium Fluoride PASTE DENTAL 20150501 OTC MONOGRAPH NOT FINAL part356 Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd SODIUM FLUORIDE .22 g/100g E 20171231 51289-500_3c1495d4-1cad-266b-e054-00144ff8d46c 51289-500 HUMAN OTC DRUG toothpowder Sodium Fluoride POWDER DENTAL 20160904 OTC MONOGRAPH NOT FINAL part356 Yangzhou Hengyuan Daily Chemical Plastic Co.,Ltd SODIUM FLUORIDE .24 g/100g E 20171231 51290-011_6b58da56-8aba-4b5a-8d23-f026a9715f32 51290-011 HUMAN OTC DRUG Medaclear zinc pyrithione SHAMPOO TOPICAL 20100908 OTC MONOGRAPH FINAL part358H Amico Educational Concepts, Inc. PYRITHIONE ZINC 15 g/L E 20171231 51293-605_4c461b5a-4023-486c-93ee-d641b499df4b 51293-605 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride TABLET ORAL 20110823 UNAPPROVED DRUG OTHER ECI Pharmaceuticals LLC ISOXSUPRINE HYDROCHLORIDE 20 mg/1 N 20181231 51293-606_4c461b5a-4023-486c-93ee-d641b499df4b 51293-606 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride TABLET ORAL 20110602 UNAPPROVED DRUG OTHER ECI Pharmaceuticals LLC ISOXSUPRINE HYDROCHLORIDE 10 mg/1 N 20181231 51293-607_8f260163-4ba5-47c4-9cd2-ef1ef8a19a2a 51293-607 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20110504 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] N 20181231 51293-611_d0334d89-6721-49c4-a862-8a7dd75c03d5 51293-611 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110823 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 51293-612_d0334d89-6721-49c4-a862-8a7dd75c03d5 51293-612 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110823 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 E 20171231 51293-617_8f5619e8-d9d7-414b-8eb2-365178080f1e 51293-617 HUMAN PRESCRIPTION DRUG Isometheptene Mucate/Dichloralphenazone/Acetaminophen ISOMETHEPTENE MUCATE, DICHLORALPHENAZONE, and ACETAMINOPHEN CAPSULE ORAL 20110215 UNAPPROVED DRUG OTHER ECI Pharmaceuticals LLC ISOMETHEPTENE MUCATE; DICHLORALPHENAZONE; ACETAMINOPHEN 65; 100; 325 mg/1; mg/1; mg/1 CIV E 20171231 51293-622_3343e80f-33c4-446b-b118-2819316f3809 51293-622 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride and Promethazine Hydrochloride Meperidine Hydrochloride and Promethazine Hydrochloride CAPSULE ORAL 20130219 UNAPPROVED DRUG OTHER ECI Pharmaceuticals LLC MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE 50; 25 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CII N 20181231 51293-625_17a2d3cf-0fc2-4f81-bc31-64ad7c0a7e5a 51293-625 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20141124 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENOBARBITAL 16.2 mg/1 CIV N 20181231 51293-626_17a2d3cf-0fc2-4f81-bc31-64ad7c0a7e5a 51293-626 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20141124 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENOBARBITAL 32.4 mg/1 CIV N 20181231 51293-627_17a2d3cf-0fc2-4f81-bc31-64ad7c0a7e5a 51293-627 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20141124 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENOBARBITAL 64.8 mg/1 CIV N 20181231 51293-628_17a2d3cf-0fc2-4f81-bc31-64ad7c0a7e5a 51293-628 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20141124 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENOBARBITAL 97.2 mg/1 CIV N 20181231 51293-801_6ec64d33-6f0c-4b44-b23a-ec06e912dd8d 51293-801 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 E 20171231 51293-802_6ec64d33-6f0c-4b44-b23a-ec06e912dd8d 51293-802 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 E 20171231 51293-803_9b295cc3-21b2-4521-8193-31dd7e3b87d3 51293-803 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20141001 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC SALSALATE 500 mg/1 N 20181231 51293-804_9b295cc3-21b2-4521-8193-31dd7e3b87d3 51293-804 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20141001 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC SALSALATE 750 mg/1 N 20181231 51293-810_a00ca09a-7d0c-409b-9fb8-5d04eef49483 51293-810 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 51293-811_a00ca09a-7d0c-409b-9fb8-5d04eef49483 51293-811 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER ECI Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 51293-820_cf544b61-c4b0-4576-82ca-a827f9a558e9 51293-820 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20160701 ANDA ANDA040547 ECI Pharmaceuticals, LLC METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 51293-821_cf544b61-c4b0-4576-82ca-a827f9a558e9 51293-821 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20160701 ANDA ANDA040547 ECI Pharmaceuticals, LLC METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 51293-825_3c6e0092-dae0-4537-b7af-e8176a211de8 51293-825 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20170225 ANDA ANDA203298 ECI Pharmaceuticals, LLC CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 51293-831_c7b4e0ed-58e5-4203-93ab-a3943012f654 51293-831 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate Sodium Polystyrene Sulfonate POWDER, FOR SUSPENSION ORAL; RECTAL 20170207 ANDA ANDA090313 ECI Pharmaceuticals, LLC SODIUM POLYSTYRENE SULFONATE 4.1 meq/g N 20181231 51312-065_caab51b5-7536-4a0f-8f74-4b4f091cf4c7 51312-065 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20100915 UNAPPROVED MEDICAL GAS AmMed, Inc. OXYGEN 995 mL/100L N 20181231 51325-100_2cd3a7e4-1a01-465c-a413-609709103087 51325-100 HUMAN OTC DRUG Rejuvaderm Medispa sunscreen Octinoxate, Octisalate, Zinc oxide LOTION TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 Ellen H Frankle MD Inc OCTINOXATE; OCTISALATE; ZINC OXIDE 9; 2.4; 9 mL/120mL; mL/120mL; mL/120mL E 20171231 51325-200_656a38b5-c598-4e10-995e-4bdbd5057e12 51325-200 HUMAN OTC DRUG Rejuvaderm Medispa Body Octinoxate, octisalate, oxybenzone LOTION TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 Ellen H Frankle MD Inc OCTINOXATE; OCTISALATE; OXYBENZONE 26.625; 17.75; 10.65 mL/355mL; mL/355mL; mL/355mL E 20171231 51325-300_d4552d19-6285-4d4f-bee0-4d18b4fd1001 51325-300 HUMAN OTC DRUG Rejuvaderm medispa fading hydroquinone LOTION TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part358A Ellen H Frankle MD Inc HYDROQUINONE 1.2 mL/60mL E 20171231 51325-400_6f861083-6259-47ff-b8b9-6c74f32dd10c 51325-400 HUMAN OTC DRUG Rejuvaderm MediSpa Acne Back Salicylic acid SPRAY TOPICAL 20100720 OTC MONOGRAPH FINAL part333D Ellen Frankle MD Inc. SALICYLIC ACID 4.8 mL/240mL E 20171231 51328-1010_61548fa7-dc86-4482-e053-2991aa0a4167 51328-1010 HUMAN OTC DRUG Royal Petroleum Jelly Petrolatum JELLY TOPICAL 20161010 OTC MONOGRAPH FINAL part347 Royal Exports PETROLATUM 100 g/100g N 20181231 51328-1011_6155c761-5d41-d85f-e053-2991aa0abbb3 51328-1011 HUMAN OTC DRUG Royal Petroleum Jelly with Cocoa Butter Scent Petrolatum JELLY TOPICAL 20161010 OTC MONOGRAPH FINAL part347 Royal Exports PETROLATUM 99.9 g/100g N 20181231 51328-1020_615574f4-09b9-3cb3-e053-2991aa0a2fa0 51328-1020 HUMAN OTC DRUG Royal Petroleum Jelly with Baby Scent White Petrolatum JELLY TOPICAL 20161010 OTC MONOGRAPH FINAL part347 Royal Exports PETROLATUM 99.9 g/100g N 20181231 51328-1021_60f37f39-9066-1882-e053-2a91aa0a72fd 51328-1021 HUMAN OTC DRUG Royal Petroleum Jelly Baby Fresh Scent Blue Petrolatum JELLY TOPICAL 20161010 OTC MONOGRAPH FINAL part347 Royal Exports PETROLATUM 99.9 g/100g N 20181231 51329-1001_8655b9fe-b324-4da2-8a5e-c19ad843fb7e 51329-1001 HUMAN OTC DRUG Doll Lash Zinc pyrithione LIQUID TOPICAL 20101106 UNAPPROVED DRUG OTHER Hanbit Korea PYRITHIONE ZINC; PANTHENOL; NIACINAMIDE; BIOTIN 2; .5; .3; .06 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 51329-2001_beccee7d-5f1e-4988-a540-f0bc35c48ebc 51329-2001 HUMAN OTC DRUG derma MOBALNA EP 90 Hair Again Toner ACORUS CALAMUS ROOT LIQUID TOPICAL 20140330 UNAPPROVED DRUG OTHER Hanbit Korea ACORUS CALAMUS ROOT .15 g/mL E 20171231 51334-013_12794868-77c4-4f9f-91dd-b0cfd8f17e8b 51334-013 HUMAN OTC DRUG Vitamin A D Lanolin, Petrolatum OINTMENT TOPICAL 20100708 OTC MONOGRAPH FINAL part347 Toys R Us, Inc LANOLIN; PETROLATUM 133; 459 mg/g; mg/g N 20191231 51335-001_6a090b5c-1f12-45f7-b056-c87b2fe1aacb 51335-001 HUMAN OTC DRUG Instant Hand Sanitizer with Moisturizers Unscented ALCOHOL LIQUID TOPICAL 20100809 OTC MONOGRAPH NOT FINAL part333E Ningbo Heyi Daily Chemical Products Co., Ltd. ALCOHOL 62 g/100g E 20171231 51335-002_1e9f45b6-1729-4635-b76f-38cc67dd54e3 51335-002 HUMAN OTC DRUG Instant Hand Sanitizer with Moisturizers Aloe Scented ALCOHOL LIQUID TOPICAL 20100809 OTC MONOGRAPH NOT FINAL part333E Ningbo Heyi Daily Chemical Products Co., Ltd. ALCOHOL 62 g/100g E 20171231 51335-003_e9f53328-2f3c-4676-8f65-498026101313 51335-003 HUMAN OTC DRUG Instant Hand Sanitizer with Moisturizers Ocean Scented ALCOHOL LIQUID TOPICAL 20100809 OTC MONOGRAPH NOT FINAL part333E Ningbo Heyi Daily Chemical Products Co., Ltd. ALCOHOL 62 g/100g E 20171231 51335-004_fb52380c-e6be-4818-8566-ac7d4470e504 51335-004 HUMAN OTC DRUG Instant Hand Sanitizer Green Apple Scented ALCOHOL LIQUID TOPICAL 20120802 OTC MONOGRAPH NOT FINAL part333E Ningbo Heyi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL E 20171231 51335-005_13b816bb-7336-44af-973e-be95d37d6238 51335-005 HUMAN OTC DRUG Instant Hand Sanitizer Fresh Lemon Scented ALCOHOL LIQUID TOPICAL 20120803 OTC MONOGRAPH NOT FINAL part333E Ningbo Heyi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL E 20171231 51335-006_8cc943f9-8bec-42cb-920a-61aaf9b22a8f 51335-006 HUMAN OTC DRUG Instant Hand Sanitizer Strawberry Scented ALCOHOL LIQUID TOPICAL 20120803 OTC MONOGRAPH NOT FINAL part333E Ningbo Heyi Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL E 20171231 51345-050_d56c70a3-1bbb-499f-be87-6397fc967af7 51345-050 HUMAN OTC DRUG Exotic Cherry Blossom Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20110407 OTC MONOGRAPH FINAL part333E Advanced Beauty Systems, Inc. ALCOHOL 70 mL/100mL E 20171231 51345-051_278d4d09-b807-40ce-a912-4e79f043e4b3 51345-051 HUMAN OTC DRUG Enchanted Forest Hand Sanitizer Bodycology Ethyl Alcohol LIQUID TOPICAL 20110407 OTC MONOGRAPH FINAL part333E Advanced Beauty Systems, Inc. ALCOHOL 22.5 mL/30mL E 20171231 51345-052_4092f88b-7fb2-4db1-a0e0-cff56a4930f2 51345-052 HUMAN OTC DRUG Fresh Cucumber Melon Bodycology Ethyl Alcohol LIQUID TOPICAL 20110407 OTC MONOGRAPH FINAL part333E Advanced Beauty Systems, Inc. ALCOHOL 22.5 mL/30mL E 20171231 51345-053_77dc19cd-d3c9-4e32-b3ea-b602dbe6c847 51345-053 HUMAN OTC DRUG Bodycology Exotic Cherry Blossom Kit Exotic Cherry Blossom KIT 20120630 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-055_506a9281-832b-4ff0-8d65-351b4ac68a31 51345-055 HUMAN OTC DRUG Bodycology Enchanted Forest Kit Enchanted Forest KIT 20120630 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-057_81a63de1-72c5-4b34-b677-b535b14f03b6 51345-057 HUMAN OTC DRUG Bodycology Toasted Vanilla Kit Toasted Vanilla KIT 20120630 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-059_106c1f98-de29-457b-9432-ddf5a766c645 51345-059 HUMAN OTC DRUG Bodycology Fresh Cucumber Kit Fresh Cucumber KIT 20120630 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-061_8626b5c7-82c0-4d38-a692-4fe1eb7189d7 51345-061 HUMAN OTC DRUG Bodycology Enchanted Forest Kit Enchanted Forest KIT 20120803 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-063_dde66f79-13bf-4681-9aee-f15062101b3f 51345-063 HUMAN OTC DRUG Bodycology Exotic Cherry Kit Exotic Cherry KIT 20120803 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-065_e28b6e69-9d22-43e3-90aa-04d2a069d2ef 51345-065 HUMAN OTC DRUG Bodycology Toasted Vanilla Sugar Kit Toasted Vanilla Sugar KIT 20120803 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-067_0d35f0e1-4acf-4493-b620-22d7e1a4276b 51345-067 HUMAN OTC DRUG Bodycology Fresh Cucumber Melon Kit Fresh Cucumber Melon KIT 20120803 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-099_2cda2490-12e0-4b87-8c8e-7e7807bf5aa4 51345-099 HUMAN OTC DRUG Epsom Salt Soaking Solution Magnesium Sulfate GRANULE TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part334 Advanced Beauty Systems, Inc. MAGNESIUM SULFATE 2.72 kg/2.72kg E 20171231 51345-105_222b38c2-2c4b-4cff-b78c-6367d1ac3e04 51345-105 HUMAN OTC DRUG Toasted Vanilla Sugar Hand Sanitizer Bodycology Ethyl Alcohol LIQUID TOPICAL 20110407 OTC MONOGRAPH FINAL part333E Advanced Beauty Systems, Inc. ALCOHOL 22.5 mL/30mL E 20171231 51345-106_18987b4b-8c63-4d24-b1f7-5de17ea58614 51345-106 HUMAN OTC DRUG Dr Teals Triple Antibiotic Bactracin, Neomycin, Polymyxin B OINTMENT TOPICAL 20120806 OTC MONOGRAPH FINAL part333B Advanced Beauty Systems, Inc. BACITRACIN; NEOMYCIN; POLYMYXIN B 400; 3.5; 5000 U/28g; mg/28g; U/28g N 20181231 51345-107_c7f1e948-8b66-4cda-941d-0ae56f78c668 51345-107 HUMAN OTC DRUG exotic cherry blossom kit bodycology alcohol KIT 20130624 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-109_731cf7e3-ed44-452e-8cbd-f4f60751370a 51345-109 HUMAN OTC DRUG Toasted Vanilla Sugar Kit Bodycology alcohol KIT 20130625 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-111_abdaec0e-aac3-4b79-a9be-8e1efd491cc6 51345-111 HUMAN OTC DRUG XOXO Kit bodycology alcohol KIT 20130627 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-113_bf6f70e5-984d-4758-937d-8d9205628cae 51345-113 HUMAN OTC DRUG Exotic Cherry Blossom Kit bodycology alcohol KIT 20130625 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-115_8be95fb2-2780-4b7b-a95a-83dd035d0178 51345-115 HUMAN OTC DRUG Toasted Vanilla Kit Bodycology alcohol KIT 20130625 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-117_7639d1fa-8425-492c-8e50-ef70307b6e6d 51345-117 HUMAN OTC DRUG XOXO Kit Bodycology alcohol KIT 20130626 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51345-119_681a849f-c307-479b-bfd2-b5a9b627f357 51345-119 HUMAN OTC DRUG Pretty in Paris Kit Bodycology alcohol KIT 20130627 OTC MONOGRAPH NOT FINAL part333E Advanced Beauty Systems, Inc. E 20171231 51346-001_eba63df1-32eb-4b62-95a2-995fb5973663 51346-001 HUMAN OTC DRUG THE FIRST SUN SPF50 PLUS PA PLUS PLUS PLUS OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE LIQUID TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE 3; 2.61; 2; 1 g/40mL; g/40mL; g/40mL; g/40mL N 20181231 51346-002_b34a61e2-b721-44c3-833b-df2ca232f67d 51346-002 HUMAN OTC DRUG TRUFFLE EX SUN SPF50 PLUS PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 3.75; 2.5; 2.4; 1.25 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 51346-003_cce26f54-e124-40b9-866e-68e81953e663 51346-003 HUMAN OTC DRUG THE FIRST FERMENTED ESSENCE BB BALM SPF25 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE .96; .36; .24 g/12g; g/12g; g/12g N 20181231 51346-004_1a708632-3dcb-4760-b468-b9340a676a57 51346-004 HUMAN OTC DRUG BERRY BABY LIP BALM RED BERRY SPF12 OCTINOXATE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE .6 g/12g N 20181231 51346-005_65425705-4fed-4415-9875-47308800a4c1 51346-005 HUMAN OTC DRUG BERRY BABY LIP BALM PEACH BERRY SPF12 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .6; .048 g/12g; g/12g N 20181231 51346-006_b364cf89-cb2f-4a7d-b674-86cd0b180cd2 51346-006 HUMAN OTC DRUG BERRY BABY LIP BALM VIOLET BERRY SPF12 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .6; .012 g/12g; g/12g N 20181231 51346-007_03f258f7-d572-43b3-99a4-aef63b20ae12 51346-007 HUMAN OTC DRUG COLLAGEN HD FOUNDATION SPF30 PA PLUS PLUS 21 SOFT BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.16; 1.2; .76 g/40mL; g/40mL; g/40mL N 20181231 51346-008_30766a8d-43f4-4b4e-b978-c43a575fbf0b 51346-008 HUMAN OTC DRUG COLLAGEN HD MAKE UP BASE SPF30 PA PLUS PLUS 01 GREEN OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 2.4; 1.6 g/40mL; g/40mL N 20181231 51346-009_9e06f457-58ff-40cb-9fa2-18238c0ec20e 51346-009 HUMAN OTC DRUG COLLAGEN HD MAKE UP BASE SPF30 PA PLUS PLUS 02 VIOLET OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.4; 1.6; .76 g/40mL; g/40mL; g/40mL N 20181231 51346-010_9d375f59-af8e-4dc1-9a88-4bcb88774ebb 51346-010 HUMAN OTC DRUG BOTANICAL VANILLA SPF25 PA PLUS 01 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.55; .5; .475 g/25g; g/25g; g/25g N 20181231 51346-011_551d984d-9f85-4438-82d0-8e5878e04254 51346-011 HUMAN OTC DRUG BOTANICAL VANILLA SPF25 PA PLUS 02 VANILLA PINK TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.525; .5; .475 g/25g; g/25g; g/25g N 20181231 51346-012_3026d217-27e3-40d9-ae53-6324af865680 51346-012 HUMAN OTC DRUG BOTANICAL VANILLA PACT SPF30 PA PLUS PLUS PLUS 21 VANILLA NUDE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.111; .55; .319 g/11g; g/11g; g/11g N 20181231 51346-013_898e77e5-ea89-43c7-ad74-f438ea2dd0be 51346-013 HUMAN OTC DRUG BOTANICAL VANILLA PACT SPF30 PA PLUS PLUS PLUS VANILLA NATURAL TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.111; .55; .319 g/11g; g/11g; g/11g N 20181231 51346-014_fa81db80-abee-488a-9952-46e40275ddd1 51346-014 HUMAN OTC DRUG BOTANICAL MOIST PACT SPF30 PA PLUS PLUS PLUS 21 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .558; .45; .261 g/9g; g/9g; g/9g N 20181231 51346-015_1ddfd532-84ae-41a5-ba3e-91b8760a75ff 51346-015 HUMAN OTC DRUG BOTANICAL PURE PACT SPF25 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .62; .4; .2 g/10g; g/10g; g/10g N 20181231 51346-016_a2a12997-4d7d-4619-b0f1-79a9043cdd06 51346-016 HUMAN OTC DRUG COLLAGEN HD AQUA BB SPF27 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 4.15; 3; 1 g/50g; g/50g; g/50g N 20181231 51346-017_2a71b822-43a3-4f7e-b6fc-f458487ecffa 51346-017 HUMAN OTC DRUG COLLAGEN HD PEARL BB SPF27 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 3.8; 3; 1 g/50g; g/50g; g/50g N 20181231 51346-018_bc2df7b2-176e-4397-82ee-b271a0b33554 51346-018 HUMAN OTC DRUG COLLAGEN HD COVER BB SPF27 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 5.65; 3; 1; .5 g/50g; g/50g; g/50g; g/50g N 20181231 51346-019_a790eb8e-0711-4f59-a1fb-3c13ac3cf62d 51346-019 HUMAN OTC DRUG COLLAGEN HD PRIIMER BB SPF27 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 4.15; 3; 1 g/50g; g/50g; g/50g N 20181231 51346-020_a4c4c446-b1a0-4b38-b6ab-13b59b83b964 51346-020 HUMAN OTC DRUG RED GINSENG FERMENTED SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE LIQUID TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 2.92; 1.72; 1.28 g/40mL; g/40mL; g/40mL N 20181231 51346-021_33d76dbf-7179-458d-928d-0d8a94dee14c 51346-021 HUMAN OTC DRUG RED GINSENG FERMENTED ESSENCE BB SPF50PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 5.52; 2.8; 1.56 g/40mL; g/40mL; g/40mL N 20181231 51346-022_e1312136-b0d3-4c1f-a191-71207b49dd50 51346-022 HUMAN OTC DRUG BEEVENOM BB SPF50PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 5.52; 2.8; 1.56 g/40mL; g/40mL; g/40mL N 20181231 51346-023_0efafa1c-d52b-4d45-920c-cbae86f5b1ee 51346-023 HUMAN OTC DRUG BEEVENOM SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 3.75; 2.15; 1 g/50mL; g/50mL; g/50mL N 20181231 51346-024_13a0a801-872c-4e74-a3a9-f0ac4bf3a53a 51346-024 HUMAN OTC DRUG BEEVENOM PACT SPF50PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.16; .6; .29 g/10g; g/10g; g/10g N 20181231 51346-025_249043e9-34c8-4e8d-978a-a6ee08064850 51346-025 HUMAN OTC DRUG MANGO BEBE LIP CARE SPF15 MINT MANGO OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .21; .11; .0003 g/3.5g; g/3.5g; g/3.5g N 20181231 51346-026_61d5236b-539c-4c90-bb44-45b100fd1f3c 51346-026 HUMAN OTC DRUG MANGO BEBE LIP CARE SPF15 RED MANGO OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .21; .105; .01 g/3.5g; g/3.5g; g/3.5g N 20181231 51346-027_80ed37bb-e219-472d-8cab-51e657d086d8 51346-027 HUMAN OTC DRUG MANGO BEBE LIP CARE SPF15 WHITE MANGO OCTINOXATE, OCTISALATE STICK TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE .21; .11 g/3.5g; g/3.5g N 20181231 51346-028_58a622f2-6ae7-4bff-b14f-0ff475f4cef7 51346-028 HUMAN OTC DRUG MANGO BEBE LIP ESSENCE SPF15 OCTINOXATE, OCTISALATE SOLUTION TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE .6; .3 g/10mL; g/10mL N 20181231 51346-029_4ebd4e7a-fafd-4a8f-aa1e-523d4793cf35 51346-029 HUMAN OTC DRUG PLACENTA EX DAY SPF30 PA PLUS PLUS OCTINOXATE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE 3.75 g/50mL N 20181231 51346-030_4bdcca67-976a-4014-b49f-096e078ea622 51346-030 HUMAN OTC DRUG PLACENTA EX ESSENCE BB SPF50PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.21; 1.12; .63 g/16g; g/16g; g/16g N 20181231 51346-031_539b3c39-4ee2-4658-ad9f-7f83e4b9949a 51346-031 HUMAN OTC DRUG PLACENTA EX SUN BALM SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .84; .73; .59 g/12g; g/12g; g/12g N 20181231 51346-032_c4c0c73a-1ca9-4ae1-a0c6-36eac080c56f 51346-032 HUMAN OTC DRUG ORCHID SECRET FOUNDATION 21 SPF28 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120115 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.76; 1.05; .66 g/35mL; g/35mL; g/35mL N 20181231 51346-033_66c10460-5eb7-4e3a-9e30-c4b72614f16a 51346-033 HUMAN OTC DRUG ORCHID SECRET FOUNDATION 23 SPF28 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20121115 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.76; 1.05; .66 g/35mL; g/35mL; g/35mL N 20181231 51346-034_662e2b08-35fa-4c43-864d-2db1c2ee1636 51346-034 HUMAN OTC DRUG ORCHID SECRET PACT SPF35 PA PLUS PLUS PLUS 21 ORCHID IVORY TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120115 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.03; .72; .35 g/12g; g/12g; g/12g N 20181231 51346-035_b653c070-cf71-45bb-84d0-63421f837c20 51346-035 HUMAN OTC DRUG ORCHID SECRET PACT SPF35 PA PLUS PLUS PLUS 23 ORCHID BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120115 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.03; .72; .35 g/12g; g/12g; g/12g N 20181231 51346-036_41ce2731-abca-492b-9192-ff8abd2c3b9f 51346-036 HUMAN OTC DRUG PHOTOSHOT 3D BB BALM SPF30 PA PLUS PLUS PLUS 21 LIGHT BEIGE TITANIUM DIOXIDE CREAM TOPICAL 20120110 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE 1.52 g/7g N 20181231 51346-037_c75e5298-d713-43cc-9282-2e7ce5d9c942 51346-037 HUMAN OTC DRUG PHOTOSHOT 3D BB BALM SPF30 PA PLUS PLUS PLUS 23 NATURAL BEIGE TITANIUM DIOXIDE CREAM TOPICAL 20120110 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE 1.52 g/7g N 20181231 51346-038_bf682ead-4d76-4489-bc50-f28212a16d84 51346-038 HUMAN OTC DRUG UV LOCK FLOWER DAILY POWERFUL SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 3.75; 2.5; 2.4; 1.25 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 51346-039_ffa6cebe-2c78-47ec-acdd-bf00599ee6bd 51346-039 HUMAN OTC DRUG UV LOCK FLOWER KIDS AND JUNIOR SUN SPF35 PA PLUS PLUS OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 3.75; 1.05 g/50mL; g/50mL N 20181231 51346-040_0e72397c-4bf6-4f59-9fb6-cb8e7d5b9244 51346-040 HUMAN OTC DRUG UV LOCK FLOWER WATER PROOF SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 3.75; 2.5; 2.45; 1.45 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 51346-041_0c949b5c-2fbb-420e-a7a7-f4be505f3210 51346-041 HUMAN OTC DRUG UV LOCK ULTRA PACT SUN SPF50PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .62; .24; .23 g/8g; g/8g; g/8g N 20181231 51346-042_22bf2199-626e-42b3-96a9-135ddcdda714 51346-042 HUMAN OTC DRUG UV LOCK ULTRA MILK SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE 3.75; 3.25; 2.5; 1.25 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 51346-043_24b22dcd-5b42-4894-87aa-12180f2e02f2 51346-043 HUMAN OTC DRUG UV LOCK ULTRA MILK SUN BIG SIZE SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE 5.25; 4.55; 3.5; 1.75 g/70mL; g/70mL; g/70mL; g/70mL N 20181231 51346-044_682285d0-f83f-4fcd-b38f-40d5bf1d37b7 51346-044 HUMAN OTC DRUG SNAIL THERAPY 50 BB SPF30 PA PLUS PLUS NO2 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.16; 1.2; .76 g/40mL; g/40mL; g/40mL N 20181231 51346-045_4f361924-cce0-444d-97ec-da6f60a33a46 51346-045 HUMAN OTC DRUG SNAIL THERAPY 50 BB SPF30 PA PLUS PLUS NO1 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.16; 1.2; .76 g/40mL; g/40mL; g/40mL N 20181231 51346-046_fb8425ac-6eca-401e-8d93-94ff8e8d425b 51346-046 HUMAN OTC DRUG MULTI PERFECTION SPECIAL EFFECTOR SPF15 OCTINOXATE, OCTISALATE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE 7.87; 4.2 g/105mL; g/105mL N 20181231 51346-047_6556e617-14cc-4304-8bdf-bd1656c72a5f 51346-047 HUMAN OTC DRUG BOTANICAL MOIST PACT SPF30 PA PLUS PLUS PLUS 23 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .56; .45; .26 g/9g; g/9g; g/9g N 20181231 51346-048_baaf4d7d-b73c-4039-9a57-5eae467e4737 51346-048 HUMAN OTC DRUG BOTANICAL FRESH BB SPF30 PA PLUS PLUS TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.6; .35 g/25mL; g/25mL N 20181231 51346-049_2351bc3e-468d-4614-be25-3e6ba79dc270 51346-049 HUMAN OTC DRUG SNAIL THERAPY PACT 21 SPF25 PA PLUS PLUS TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.07; .11 g/11g; g/11g N 20181231 51346-050_cb95d270-a153-43ba-8f49-244dd65933cb 51346-050 HUMAN OTC DRUG SNAIL THERAPY PACT 23 SPF25 PA PLUS PLUS TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.07; .11 g/11g; g/11g N 20181231 51346-051_3dfecfee-4984-4470-ad59-17aa12ae61b1 51346-051 HUMAN OTC DRUG BLEMISH LAB BYE PORE BB SPF30 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.37; .9; .57 g/30mL; g/30mL; g/30mL N 20181231 51346-052_cb3355a4-d777-4235-a574-746b5fcccd82 51346-052 HUMAN OTC DRUG SUPER ORIGIN COLLAGEN WATERPROOF BB SPF46 PA PLUS PLUS PLUS OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, OCTISALATE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE; OCTISALATE 3.15; 3.1; 2.2; 1.35 g/45g; g/45g; g/45g; g/45g N 20181231 51346-053_31b22ca2-0f54-4a03-8846-91bb952216de 51346-053 HUMAN OTC DRUG SUPER ORIGIN CERAMIDE BB SPF25 PA PLUS PLUS TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.47; .63 g/45g; g/45g N 20181231 51346-054_ba0632d9-9200-4b5a-94bf-2b5602d6adb3 51346-054 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX BB SPF30 PA PLUS PLUS 01 LIGHT BB TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20111130 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.92; 1.35; .86 g/45g; g/45g; g/45g N 20181231 51346-055_9ea801dd-9c76-4531-a7bb-b714c45023e8 51346-055 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX BB SPF30 PA PLUS PLUS 02 NATURAL TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20111130 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.92; 1.35; .86 g/45g; g/45g; g/45g N 20181231 51346-056_4745ac76-5706-424c-a93f-c0ba1d3c608e 51346-056 HUMAN OTC DRUG ORCHID SECRET SPF30 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20111130 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 1.25; .23 g/12g; g/12g N 20181231 51346-057_60998fa6-6653-4933-b5b3-5389ea22eaeb 51346-057 HUMAN OTC DRUG VIVID TINT BAR 02 SPF15 PA PLUS TITANIUM DIOXIDE STICK TOPICAL 20111130 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE .002 g/3.5g N 20181231 51346-058_966eed6b-b959-4511-acc0-050a3e446a6b 51346-058 HUMAN OTC DRUG TRUFFLE EX RETINOL SPOT DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .64 g/40mL N 20181231 51346-059_bbbee0c5-efa5-4e5a-be33-f0d85f066605 51346-059 HUMAN OTC DRUG TRUFFLE EX WRINKLE DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1 g/50mL N 20181231 51346-060_87db63c6-b22f-453c-87b0-97293b21dec8 51346-060 HUMAN OTC DRUG TRUFFLE EX WRINKLE EMULSION DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.65 g/150mL N 20181231 51346-061_866c6e53-4c5d-4fe8-a18e-95b6b088c54b 51346-061 HUMAN OTC DRUG TRUFFLE EX WRINKLE ESSENCE DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2 g/40mL N 20181231 51346-062_c31e386f-298b-4bc6-ab84-d930076678df 51346-062 HUMAN OTC DRUG TRUFFLE EX WRINKLE EYE DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .75 g/30mL N 20181231 51346-063_9c37a53c-9355-4865-b5ae-903a45ae55f6 51346-063 HUMAN OTC DRUG PLACENTA EX ESSENCE Dimethicone CREAM TOPICAL 20101001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .4 g/40mL N 20181231 51346-064_45b73f8b-0002-48cc-b8c8-d347abb76bbb 51346-064 HUMAN OTC DRUG PLACENTA EX EMULSION Dimethicone CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2.38 g/140mL N 20181231 51346-065_ef6b7fcc-cc14-42f0-9238-1b199997f5d1 51346-065 HUMAN OTC DRUG PLACENTA EX NIGHT Dimethicone CREAM TOPICAL 20101001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 6.75 g/50mL N 20181231 51346-066_000e42cd-7833-4dca-bcaa-b839572ccbe1 51346-066 HUMAN OTC DRUG CELLBOOSTING HOMME DIMETHICONE LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/150mL N 20181231 51346-067_3da96469-1126-48e6-ad7a-6bbb45f1fc42 51346-067 HUMAN OTC DRUG CELLBOOSTING HOMME SKIN GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30.75 g/150mL N 20181231 51346-068_b0d1ae50-d750-4219-a576-d1d5a0b66eaa 51346-068 HUMAN OTC DRUG CELLBOOSTING WHITENING TONER GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 31.2 g/150mL N 20181231 51346-069_d168d457-358f-44a3-af7e-5a7a273efbf1 51346-069 HUMAN OTC DRUG CELLBOOSTING HOMME WHITENING FLUID DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/150mL N 20181231 51346-070_86c55d58-8e38-425b-ab40-90f7d9ed9140 51346-070 HUMAN OTC DRUG POLYNESIA LAGOON WATER HYDRO SKIN GLYCERIN, DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; DIMETHICONE 38.52; 6.84 g/180mL; g/180mL N 20181231 51346-071_48d4de10-8f68-468d-a7e3-ffb49e9c2c76 51346-071 HUMAN OTC DRUG POLYNESIA LAGOON WATER HYDRO EMULSION GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 37.8 g/180mL N 20181231 51346-072_d33911ce-2c5b-4245-987c-e105d19f68dd 51346-072 HUMAN OTC DRUG POLYNESIA LAGOON WATER HYDRO ESSENCE DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .55 g/50mL N 20181231 51346-073_863d9c38-998a-4329-bf7b-8f22ba046dd9 51346-073 HUMAN OTC DRUG POLYNESIA LAGOON WATER HYDRO DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.1 g/55mL N 20181231 51346-074_b0495cf1-8758-4512-803f-fe1ef20c138e 51346-074 HUMAN OTC DRUG POLYNESIA LAGOON WATER HYDRO EYE GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 7 g/35mL N 20181231 51346-076_0cdc57e4-0e5b-44c3-930b-bd967ed15800 51346-076 HUMAN OTC DRUG COLLAGEN HD FOUNDATION SPF30 PA PLUS PLUS 21 SOFT BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.16; 1.2; .76 g/40mL; g/40mL; g/40mL N 20181231 51346-077_1e115264-2388-4ca2-a2d5-86d17688e97b 51346-077 HUMAN OTC DRUG BOTANICAL FRESH BB SET SPF30 PA PLUS PLUS Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120401 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.6; .35 g/1; g/1 N 20181231 51346-078_0fca1589-0c9c-42c9-ba51-e5b73c036e0f 51346-078 HUMAN OTC DRUG SUPER ORIGIN COLLAGEN BB SPF25 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120401 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.88; 1.35; .85 g/45g; g/45g; g/45g N 20181231 51346-079_b25f09ce-ea45-4a7a-a59c-6d98f952b661 51346-079 HUMAN OTC DRUG THE FIRST EMULSION DIMETHICONE CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/150mL N 20181231 51346-080_ebb37f33-f03d-4735-ad99-37324dd7d93a 51346-080 HUMAN OTC DRUG THE FIRST AMPOULE ESSENCE GLYCERIN CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 10.16 g/40mL N 20181231 51346-081_7930301d-5130-468b-9b9d-389a2f03c36c 51346-081 HUMAN OTC DRUG THE FIRST DIMETHICONE CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.55 g/50mL N 20181231 51346-082_864893a7-f34a-4db8-8d5e-5edb10c3afe0 51346-082 HUMAN OTC DRUG THE FIRST EYE DIMETHICONE CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .81 g/30mL N 20181231 51346-083_7b3f1abe-9b54-4d3d-8791-8ef7a7221e1c 51346-083 HUMAN OTC DRUG GIVEN BY NATURE ALOE MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.83 g/23mL N 20181231 51346-084_924e1c31-c445-461c-9e39-2b37c8bcde46 51346-084 HUMAN OTC DRUG GIVEN BY NATURE BAMBOO MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.6 g/23mL N 20181231 51346-085_90c4e191-0637-4122-b416-c253b2f696fc 51346-085 HUMAN OTC DRUG GIVEN BY NATURE ROSE HIP MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.6 g/23mL N 20181231 51346-086_5b8721ab-6a22-4d9e-b77a-444f87dca074 51346-086 HUMAN OTC DRUG GIVEN BY NATURE CHERRY BLOSSOM MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.6 g/23mL N 20181231 51346-087_b4a902c4-4d48-4796-8bcb-5b1dcd8be572 51346-087 HUMAN OTC DRUG SOLIE TONER GLYCERIN, ALLANTOIN CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; ALLANTOIN 30; .75 g/150mL; g/150mL N 20181231 51346-088_7638a441-1745-440c-bbd5-1cab2618dd6f 51346-088 HUMAN OTC DRUG SOLIE EMULSION DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 9.75 g/150mL N 20181231 51346-089_014458ed-f965-4901-a46b-749c549513cf 51346-089 HUMAN OTC DRUG SOLIE ESSENCE GLYCERIN CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 10 g/50mL N 20181231 51346-090_627d6fe8-cfb3-445f-bb67-ca0436df79c5 51346-090 HUMAN OTC DRUG SOLIE DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .77 g/55mL N 20181231 51346-091_f3b6e497-8df5-4f52-9e9f-7f41460c3f2f 51346-091 HUMAN OTC DRUG SOLIE EYE DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.35 g/30mL N 20181231 51346-092_4be2929f-8d54-4aca-a369-6014ec16a584 51346-092 HUMAN OTC DRUG RED GINSENG FERMENTED ESSENCE BOOSTER Dimethicone CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2 g/80mL N 20181231 51346-093_8ab543e3-1776-46aa-8e8b-9fe8a125b652 51346-093 HUMAN OTC DRUG RED GINSENG FERMENTED TONER Glycerin CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 28 g/140mL N 20181231 51346-094_643bcdcc-21b6-4372-b42b-5dc4d6f2fe97 51346-094 HUMAN OTC DRUG RED GINSENG FERMENTED EMULSION Dimethicone CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2.66 g/140mL N 20181231 51346-095_21041e47-f7c5-481d-b9b8-418820ae594f 51346-095 HUMAN OTC DRUG RED GINSENG FERMENTED ESSENCE Dimethicone CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.6 g/40mL N 20181231 51346-096_258b764f-82dc-44d5-955d-dd37db5302d1 51346-096 HUMAN OTC DRUG RED GINSENG FERMENTED Dimethicone CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.25 g/50mL N 20181231 51346-097_a3d1c952-6ea6-4e9a-b64d-27db7b042fab 51346-097 HUMAN OTC DRUG RED GINSENG FERMENTED Dimethicone OIL TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.2 g/30mL N 20181231 51346-098_dee39131-cb63-483a-930f-2434bc79a11b 51346-098 HUMAN OTC DRUG ESSENTIAL SOLUTION COLLAGEN MASK SHEET GLYCERIN, ALLANTOIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; ALLANTOIN 6.72; .14 g/28g; g/28g N 20181231 51346-099_89d0f1ab-281e-416d-9650-7fbf36885e0d 51346-099 HUMAN OTC DRUG ESSENTIAL SOLUTION HYALURONIC ACID MASK SHEET GLYCERIN, ALLANTOIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; ALLANTOIN 5.6; .14 g/28g; g/28g N 20181231 51346-100_6145e14a-e11b-4c5f-8125-10cdd7888c18 51346-100 HUMAN OTC DRUG ESSENTIAL SOLUTION COENZYME Q10 MASK SHEET GLYCERIN, ALLANTOIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; ALLANTOIN 5.6; .14 g/28g; g/28g N 20181231 51346-101_54a5a69d-77d9-4c70-8f18-bf95940d543a 51346-101 HUMAN OTC DRUG ESSENTIAL SOLUTION VITA A MASK SHEET GLYCERIN, ALLANTOIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; ALLANTOIN 5.6; .14 g/28g; g/28g N 20181231 51346-102_d41185c0-ec6c-4d57-bda5-ee183750f2f3 51346-102 HUMAN OTC DRUG ESSENTIAL SOLUTION VITA C MASK SHEET GLYCERIN, ALLANTOIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; ALLANTOIN 5.6; .14 g/28g; g/28g N 20181231 51346-103_3881eb0c-21a6-4c65-a1ee-b39f4eb168fa 51346-103 HUMAN OTC DRUG ESSENTIAL SOLUTION RED GINSENG MASK SHEET GLYCERIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4 g/20mL N 20181231 51346-104_657a1d55-8703-40c7-8bc2-9a6fbb29568d 51346-104 HUMAN OTC DRUG ESSENTIAL SOLUTION CAVIAR MASK SHEET GLYCERIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4 g/20mL N 20181231 51346-105_d2a1c4bc-d61f-426c-90ad-940890793996 51346-105 HUMAN OTC DRUG ESSENTIAL SOLUTION PEARL MASK SHEET GLYCERIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4 g/20mL N 20181231 51346-106_02ce3f7f-e4f7-4d73-87e8-d4a8675b964f 51346-106 HUMAN OTC DRUG ESSENTIAL SOLUTION HONEY MASK SHEET GLYCERIN CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4 g/20mL N 20181231 51346-107_aa34fc92-45f4-4275-956d-2748f1e0255f 51346-107 HUMAN OTC DRUG BEEVENOM TONER Glycerin CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 g/150mL N 20181231 51346-108_3faed97c-badd-4103-b709-13d2b78d28bc 51346-108 HUMAN OTC DRUG BEEVENOM EMULSION Glycerin CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 g/150mL N 20181231 51346-109_d843d4b7-c87e-4214-af1c-13cd02e29e8e 51346-109 HUMAN OTC DRUG BEEVENOM ESSENCE Dimethicone CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .36 g/30mL N 20181231 51346-110_aef38ebd-7dcf-4754-8121-e2d5c99d20d6 51346-110 HUMAN OTC DRUG BEEVENOM Glycerin, Dimethicone CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; DIMETHICONE 10; .5 g/50mL; g/50mL N 20181231 51346-111_0af7ad6f-abc8-462c-9fb3-f370f03a441f 51346-111 HUMAN OTC DRUG BEEVENOM MASK SHEET GLYCERIN, ALLANTOIN CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; ALLANTOIN 4.83; .115 g/23mL; g/23mL N 20181231 51346-112_3e52b88f-8aaf-46b6-8420-d90aaa817553 51346-112 HUMAN OTC DRUG GIVEN BY NATURE GREEN TEA MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.6 g/23mL N 20181231 51346-113_bcca49c0-7cea-46c9-998a-98f3a505af65 51346-113 HUMAN OTC DRUG GIVEN BY NATURE OLIVE MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.83 g/23mL N 20181231 51346-114_a1bdfd97-406f-4e16-9f12-5fa68a189631 51346-114 HUMAN OTC DRUG GIVEN BY NATURE TEA TREE MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.6 g/23mL N 20181231 51346-115_b896ce5b-8ddb-403e-99c2-0e1e5323e235 51346-115 HUMAN OTC DRUG GIVEN BY NATURE RICE MASK SHEET GLYCERIN CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.6 g/23mL N 20181231 51346-116_97a2f7a6-63e3-4603-973b-401831e67806 51346-116 HUMAN OTC DRUG GIVEN BY NATURE SHEA BUTTER MASK SHEET DIMETHICONE CREAM TOPICAL 20110501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .46 g/23mL N 20181231 51346-117_4e18fa24-20fe-4659-afc2-69dfba4f7d1e 51346-117 HUMAN OTC DRUG BETTER THAN NATURE SKIN SOFTNER GLYCERIN CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 g/150mL N 20181231 51346-118_18ca97e9-febf-4405-9ee4-6a64aae7b6b5 51346-118 HUMAN OTC DRUG BETTER THAN NATURE EMULSION DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2.25 g/150mL N 20181231 51346-119_d30765d3-b163-461a-bf90-ef1473559f96 51346-119 HUMAN OTC DRUG BETTER THAN NATURE ESSENCE DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.25 g/50mL N 20181231 51346-120_2b9b7363-9915-4e20-a108-a2f2aab1f36f 51346-120 HUMAN OTC DRUG BETTER THAN NATURE EYE ESSENCE DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .3 g/30mL N 20181231 51346-121_f15eb156-5ec9-4751-96c7-62c5c17a3e37 51346-121 HUMAN OTC DRUG THE BAMBOO OF DAMYANG MOISTURE TONER GLYCERIN CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 g/150mL N 20181231 51346-122_7b419f31-9280-4f3f-990a-a20c276e8432 51346-122 HUMAN OTC DRUG THE BAMBOO OF DAMYANG MOISTURE DIMETHICONE LOTION TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/150mL N 20181231 51346-123_6a1af5a2-d866-4ef6-bf11-06a830fcc924 51346-123 HUMAN OTC DRUG THE BAMBOO OF DAMYANG MOISTURE ESSENCE DIMETHICONE, ALLANTOIN CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE; ALLANTOIN .4; .2 g/40mL; g/40mL N 20181231 51346-124_2be28b46-62bb-4aa0-88dc-c12982ba46ed 51346-124 HUMAN OTC DRUG THE BAMBOO OF DAMYANG MOISTURE EYE DIMETHICONE CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .5 g/25mL N 20181231 51346-125_6095c198-0f4e-495c-9369-b1be704d545e 51346-125 HUMAN OTC DRUG SUPER AQUA MAX DEEP MOISTURE HYDROGEL MASK SHEET Glycerin, Allantoin CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; ALLANTOIN 5; .125 g/25g; g/25g N 20181231 51346-126_e493ca4f-19ea-4865-b94b-ce389678acb2 51346-126 HUMAN OTC DRUG SUPER AQUA MAX DEEP MOISTURE SLEEPING PACK DIMETHICONE CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2 g/100mL N 20181231 51346-127_864869b7-9116-4d88-9a1f-dfb802bf0ccb 51346-127 HUMAN OTC DRUG SUPER AQUA MAX WHITE C WATERFUL TONER Glycerin CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 g/150mL N 20181231 51346-128_1cbe2aac-d7f3-427c-b6e8-46bed104943c 51346-128 HUMAN OTC DRUG SUPER AQUA MAX WHITE C WATERFUL EMULSION Dimethicone CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/150mL N 20181231 51346-129_aa19a8bd-8abf-4e28-9ff9-1abab0ff9778 51346-129 HUMAN OTC DRUG SUPER AQUA MAX WHITE C CRYSTAL ESSENCE Glycerin CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 8 g/40mL N 20181231 51346-130_eb5ad6af-f469-4ac4-9e5d-e7e3084688a4 51346-130 HUMAN OTC DRUG SUPER AQUA MAX WHITE C LUMINOUS AMPOULE DIMETHICONE CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.575 g/35mL N 20181231 51346-131_a3deca27-ce3f-47db-b4b4-778dc492b927 51346-131 HUMAN OTC DRUG SUPER AQUA MAX WHITE C EYE BRIGHTENER DIMETHICONE CREAM TOPICAL 20110801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .3 g/20mL N 20181231 51346-132_0bf8839b-91e3-4f6e-9b42-bc175783a89e 51346-132 HUMAN OTC DRUG ORIGINAL POWER ENERGY AMPOULE GLYCERIN, DIMETHICONE SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; DIMETHICONE 6.57; .3 g/30mL; g/30mL N 20181231 51346-133_f4471811-332b-4019-a160-3f6eb064ab9d 51346-133 HUMAN OTC DRUG ORIGINAL POWER WHITENING AND LINELESS AMPOULE GLYCERIN, DIMETHICONE SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; DIMETHICONE 6.72; .48 g/30mL; g/30mL N 20181231 51346-134_02fa00df-02c8-4a12-88ba-f760a53053bc 51346-134 HUMAN OTC DRUG ORIGINAL POWER HYDRO AMPOULE GLYCERIN, DIMETHICONE SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; DIMETHICONE 6; .3 g/30mL; g/30mL N 20181231 51346-135_8029d6ec-dd7e-4448-9cce-3ad7a49dba3e 51346-135 HUMAN OTC DRUG ORIGINAL POWER LIFTING AMPOULE GLYCERIN, DIMETHICONE SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; DIMETHICONE 6.66; .3 g/30mL; g/30mL N 20181231 51346-136_3b5aed0d-2ba5-4088-9ac2-8a12a3df2e29 51346-136 HUMAN OTC DRUG ORIGINAL POWER ARGAN OIL AMPOULE WITCH HAZEL SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .015 g/30mL N 20181231 51346-137_5c67ffb5-1ed2-41b7-b98b-26ad06c071c1 51346-137 HUMAN OTC DRUG SNAYTOX ESSENCE BOOSTER DIMETHICONE CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .4 g/40mL N 20181231 51346-138_89bac60d-28b0-4307-b70a-bdb7e94ddb05 51346-138 HUMAN OTC DRUG SNAYTOX ESSENCE DIMETHICONE CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .76 g/40mL N 20181231 51346-139_8e85e7e3-70f8-4f5a-ac0a-fc0691259f1e 51346-139 HUMAN OTC DRUG SNAYTOX DIMETHICONE CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.65 g/55mL N 20181231 51346-140_360e4241-312a-4f1e-9eb8-a7c397e5f590 51346-140 HUMAN OTC DRUG SNAYTOX EYE AND LIP DIMETHICONE CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .375 g/25mL N 20181231 51346-141_c17ec7e9-dd95-4be4-9cd3-471381ad93a2 51346-141 HUMAN OTC DRUG SOOTHING AND MOISTURE ALOE VERA 90 PERCENT TONER Glycerin CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 36 g/160mL N 20181231 51346-142_710638f7-5156-4e8d-b0bc-6ee38a57dbd8 51346-142 HUMAN OTC DRUG SOOTHING AND MOISTURE ALOE VERA 80 PERCENT EMULSION Dimethicone CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2.56 g/160mL N 20181231 51346-143_5d6f5657-d037-4e62-b34c-105f7110a4fa 51346-143 HUMAN OTC DRUG SOOTHING AND MOISTURE ALOE VERA 92 PERCENT SOOTHING Glycerin GEL TOPICAL 20110901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 60 g/300mL N 20181231 51346-144_cd72315a-c2cc-420b-b2ae-debe4a333a1c 51346-144 HUMAN OTC DRUG SNAYTOX ANTI WRINKLE HYDRO MASK GLYCERIN GEL TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 5 g/25g N 20181231 51346-145_57a889cf-8a72-4468-8721-ceae2dae53e2 51346-145 HUMAN OTC DRUG SNAYTOX WRINKLE FILLER SPECIAL SET Glycerin CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4 g/20mL N 20181231 51346-146_8b273789-5be8-435e-81b2-af3d15a8d5f3 51346-146 HUMAN OTC DRUG SNAIL THERAPY 1000 HYDROGEL MASK SHEET GLYCERIN CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4.2 g/20g N 20181231 51346-147_c9d73014-841e-4243-bc0e-42e45cc9a386 51346-147 HUMAN OTC DRUG SNAIL THERAPY 90 SKIN BOOSTER Dimethicone CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.2 g/120mL N 20181231 51346-148_f9db3412-6e62-4f0f-93ff-5194c44d2451 51346-148 HUMAN OTC DRUG SNAIL THERAPY 80 EMULSION DIMETHICONE CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.296 g/120mL N 20181231 51346-149_640befda-dcf7-47dd-abd1-4860ea886ed3 51346-149 HUMAN OTC DRUG SNAIL THERAPY 70 ESSENCE DIMETHICONE CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .968 g/40mL N 20181231 51346-150_fa12e126-3391-468c-af62-910b0f6a45f1 51346-150 HUMAN OTC DRUG SNAIL THERAPY 50 SLEEPING MASK DIMETHICONE CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.6 g/100mL N 20181231 51346-151_d2956006-dd7d-43f9-8bb8-d5ee9b8cdb05 51346-151 HUMAN OTC DRUG SNAIL THERAPY 70 EYE GLYCERIN CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 6 g/30mL N 20181231 51346-152_28ca1d3e-9949-4ff2-8e48-683c2d4c510f 51346-152 HUMAN OTC DRUG SNAIL THERAPY 80 AMPOULE DIMETHICONE SOLUTION TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .3 g/30mL N 20181231 51346-153_437153e5-3741-4acf-bf78-656bcb71dbfc 51346-153 HUMAN OTC DRUG SNAIL THERAPY 70 SPECIAL SET DIMETHICONE CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .77 g/55mL N 20181231 51346-154_b6dc8856-b41f-4623-8e77-e0f469babd3f 51346-154 HUMAN OTC DRUG PLEASURE GARDEN HOMME SPORTS MASK GLYCERIN CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 4 g/20mL N 20181231 51346-155_c5b6be7f-7b12-4e41-b99e-e88203a84714 51346-155 HUMAN OTC DRUG TRUFFLE EX CLEANSING MINERAL OIL OIL TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. MINERAL OIL 100 g/200mL N 20181231 51346-156_f7d55f9b-c7c0-4f86-8f22-143a2aa0fe04 51346-156 HUMAN OTC DRUG TRUFFLE EX WRINKLE TONER GLYCERIN CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 32.7 g/150mL N 20181231 51346-157_8acaae97-8200-4a99-8bbc-3a9aec10b4ac 51346-157 HUMAN OTC DRUG TRUFFLE EX TREATMENT WITCH HAZEL OIL TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .015 g/30mL N 20181231 51346-158_66aa1301-0ce1-4162-b68d-4132e479c908 51346-158 HUMAN OTC DRUG TRUFFLE EX WRINKLE SLEEPING MASK Dimethicone CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 3.6 g/90mL N 20181231 51346-159_3c71a760-2113-40f0-a325-01edc99a1ecc 51346-159 HUMAN OTC DRUG PLACENTA EX TONER Dimethicone CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.4 g/140mL N 20181231 51346-160_bb2eec8b-8ef0-4753-8a89-b62817166442 51346-160 HUMAN OTC DRUG PLACENTA EX EYE Dimethicone CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .36 g/30mL N 20181231 51346-161_a9b9e9aa-f5bb-4b7d-adc4-a9fd91d63629 51346-161 HUMAN OTC DRUG PLACENTA EX AMPOULE Glycerin SOLUTION TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 7.35 g/30mL N 20181231 51346-162_dbee1c33-7f76-4407-b253-4a154d9bf5fe 51346-162 HUMAN OTC DRUG ESSENTIAL BODY RELAXING ESSENCE Glycerin CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 53.67 g/250mL N 20181231 51346-163_11608ebb-05ef-4f5a-89ca-b1e713709d44 51346-163 HUMAN OTC DRUG ESSENTIAL BODY MOISTURIZING ESSENCE Glycerin CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 53.67 g/250mL N 20181231 51346-164_cd724ce1-8e89-462d-a331-4e83131d9a49 51346-164 HUMAN OTC DRUG ESSENTIAL BODY NUTRITIVE BUTTER Glycerin, Dimethicone CREAM TOPICAL 20111001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; DIMETHICONE 40; 2 g/200mL; g/200mL N 20181231 51346-165_d50006f9-d00d-4f1f-85b0-9c79eb8d8d33 51346-165 HUMAN OTC DRUG MACCOLA Glycerin SOAP TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 12 g/60g N 20181231 51346-166_f2776fd6-ee02-42a3-b58f-9212b514041a 51346-166 HUMAN OTC DRUG THE FIRST WHITENING SLEEPING MASK Glycerin CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 18 g/90mL N 20181231 51346-167_ecca5c21-d32c-4f63-a99a-27ff94f69595 51346-167 HUMAN OTC DRUG BEEVENOM SLEEPING MASK Glycerin CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 18 g/90mL N 20181231 51346-168_39c770cd-e275-4c08-a877-1e1ae3ccea4e 51346-168 HUMAN OTC DRUG AQUA COLLAGEN SOLUTION MARINE HYDROGEL EYE GLYCERIN PATCH TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 1.7 g/8.5g N 20181231 51346-169_89083a9f-d027-4d43-ba37-20f3415f9966 51346-169 HUMAN OTC DRUG AQUA COLLAGEN SOLUTION MARINE HYDROGEL MASK DIMETHICONE CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .2 g/20g N 20181231 51346-170_06f54bc0-50d9-4cf4-ad78-4903f0139ace 51346-170 HUMAN OTC DRUG AQUA COLLAGEN SOLUTION EYE TREATMENT MASK Glycerin CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 1.8 g/9g N 20181231 51346-171_7ac2df46-7e4f-4afa-abaa-333ded6e9577 51346-171 HUMAN OTC DRUG FRESH AFTER VACANCE BODY SOOTHING Glycerin GEL TOPICAL 20111101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 mL/150mL N 20181231 51346-172_e00ad3d2-5d8c-4482-a52f-6faccd1150bd 51346-172 HUMAN OTC DRUG ORCHID SECRET BASE 01 SECRET GREEN TITANIUM DIOXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE .8 g/35mL N 20181231 51346-173_76cdaf13-d250-4b22-a0c7-aa57025d5ad3 51346-173 HUMAN OTC DRUG ORCHID SECRET BASE 02 SECRET PEARL PINK TITANIUM DIOXIDE CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE .87 mL/35mL N 20181231 51346-174_3180a867-e62f-485f-9514-cdcc205f24c7 51346-174 HUMAN OTC DRUG SOOTHING AND MOISTURE ALOE VERA 90 PERCENT BODY Glycerin CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 30 g/150mL N 20181231 51346-175_c50db061-702f-474a-a013-40dae8b83a1e 51346-175 HUMAN OTC DRUG HAND AND NATURE ANTI WRINKLE HAND ARAGON OIL Glycerin, Dimethicone CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; DIMETHICONE 12; .6 g/60mL; g/60mL N 20181231 51346-176_ba995c71-ff1c-491f-9609-a3859108fe3c 51346-176 HUMAN OTC DRUG HAND AND NATURE ANTI WRINKLE HAND ALMOND OIL Glycerin, Dimethicone CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; DIMETHICONE 12; .6 g/60mL; g/60mL N 20181231 51346-177_f66de533-9ecc-4092-b228-d08eaf81f3e3 51346-177 HUMAN OTC DRUG MULTI PERFECTION MAX DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1 g/50mL N 20181231 51346-178_bde9df31-9ed9-4b35-94be-4c389d44ff88 51346-178 HUMAN OTC DRUG MULTI PERFECTION SUPER Glycerin CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 11.45 g/50mL N 20181231 51346-179_8be58a98-9708-4064-a4a5-09d2b73ea8e7 51346-179 HUMAN OTC DRUG MULTI PERFECTION ULTRA DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/50mL N 20181231 51346-180_982b45ed-4478-48b1-a702-23da86aae85b 51346-180 HUMAN OTC DRUG AFRICA BIRD HOMME ALL IN ONE MOISTURIZER GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 31.5 g/150mL N 20181231 51346-181_d4444a61-ac72-4dca-9554-b8a770da1088 51346-181 HUMAN OTC DRUG AFRICA BIRD HOMME ALL IN ONE FRESH CONTROLLER DIMETHICONE CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.95 g/150mL N 20181231 51346-182_01928dd3-80fc-4ce3-89ba-d80cbeacedca 51346-182 HUMAN OTC DRUG FOREVER LASTING PRECIOUS OIL ESSENCE GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 8.15 g/40mL N 20181231 51346-183_fe1a21e2-765a-400f-9b9e-33d7783360f4 51346-183 HUMAN OTC DRUG FOREVER LASTING PRECIOUS ESSENTIAL WATER GLYCERIN CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 31.65 g/155mL N 20181231 51346-184_ba00abae-ec39-4b99-89c2-25a2ea1d1f2b 51346-184 HUMAN OTC DRUG SHAKING SMOOTHIE ALOE MASK Witch Hazel CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .01 g/1 N 20181231 51346-185_518dcaa0-3961-4b9c-a0b1-97894b97225b 51346-185 HUMAN OTC DRUG SHAKING SMOOTHIE LEMON MASK Witch Hazel CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .01 g/1 N 20181231 51346-186_7d3a74ea-9b02-45a9-9611-8a54c8d505c8 51346-186 HUMAN OTC DRUG THE FIRST CLEAR TONER WITCH HAZEL CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .09 g/150mL N 20181231 51346-187_310b871a-5329-420d-b232-31c0b650f748 51346-187 HUMAN OTC DRUG COLLAGEN HD FOUNDATION SPF30 PA PLUS PLUS 23 MEDIUM BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.16; 1.2; .76 g/40mL; g/40mL; g/40mL N 20181231 51346-188_d75ba793-a26d-4559-8cbb-b6ebee33ba24 51346-188 HUMAN OTC DRUG FOREVER LASTING ESSENTIAL EMULSION DIMETHICONE CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 5.45 g/125mL N 20181231 51346-189_05345f3e-4b23-4df2-943f-5ab543b3205b 51346-189 HUMAN OTC DRUG FOREVER LASTING PRECIOUS MELTING DIMETHICONE CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .605 g/55mL N 20181231 51346-190_937580f1-512b-4827-bb5a-b3b6c18c0d0a 51346-190 HUMAN OTC DRUG FOREVER LASTING INTENSIVE SPOT DIMETHICONE CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .46 g/20mL N 20181231 51346-191_2b4e7a73-e142-4c42-ae58-d387008427da 51346-191 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX DAY Dimethicone CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.375 g/55mL N 20181231 51346-192_14fe1e94-670a-4e3f-8903-c2b8e7c1e41d 51346-192 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX NIGHT Glycerin CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 11.55 g/55mL N 20181231 51346-193_a3e4f52c-d794-4665-89f2-e68599862aca 51346-193 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX FLUID Dimethicone CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.32 g/120mL N 20181231 51346-194_0c0f511a-c547-4e7e-a1b9-3a5868c4064c 51346-194 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX EYE Dimethicone CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .3 g/25mL N 20181231 51346-195_d9ed52f6-7ffd-4275-9d5c-696fcf0af71b 51346-195 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX SERUM Dimethicone CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .48 g/40mL N 20181231 51346-196_c2ac078a-e2f1-4561-ac51-011f97bbb7a4 51346-196 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX TONER Glycerin CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 24.6 g/120mL N 20181231 51346-197_5ccae925-e6a4-41e2-b88a-50572b4a94af 51346-197 HUMAN OTC DRUG ADVANCED CELL BOOSTING EX WATERY Glycerin CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 12.1 g/55mL N 20181231 51346-198_ffbb4b51-7233-4e11-8d5d-d8a978903958 51346-198 HUMAN OTC DRUG PLACENTA EX DEEP LINE WITCH HAZEL PATCH TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .0007 g/21 N 20181231 51346-199_aee6e36a-cded-4108-82c9-d85d0e67e2be 51346-199 HUMAN OTC DRUG SNAYTOX HYDROGEL LIP Witch Hazel PATCH TOPICAL 20120701 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .1 g/10g N 20181231 51346-200_b34a465f-769a-4fce-8c77-25c1bbdcab0f 51346-200 HUMAN OTC DRUG PROVENCE MELTING FOUNDATION BRIGHT BEIGE SPF32 PA PLUS PLUS Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.47; .65; .63 g/13g; g/13g; g/13g N 20181231 51346-201_41cbb659-8cc2-4ab1-a7b7-2030b1527d83 51346-201 HUMAN OTC DRUG PROVENCE MELTING FOUNDATION NATURAL BEIGE SPF32 PA PLUS PLUS Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.47; .65; .63 g/13g; g/13g; g/13g N 20181231 51346-202_97763693-3307-4a01-97d8-f57b0e83ae1e 51346-202 HUMAN OTC DRUG PROVENCE FOUNDATION SPF31 PA PLUS PLUS NO 21 Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.65; 1.4; .34 mg/35mL; mg/35mL; mg/35mL N 20181231 51346-203_73bb9b94-3ab1-4c03-9e21-e13aa09534ac 51346-203 HUMAN OTC DRUG PROVENCE FOUNDATION SPF31 PA PLUS PLUS NO 23 Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.65; 1.4; .34 mg/35mL; mg/35mL; mg/35mL N 20181231 51346-204_2e9b85bc-3502-424f-828e-e07e0c7c5c88 51346-204 HUMAN OTC DRUG PROVENCE MAKEUP BASE SPF30 PA PLUS PLUS 01 MINT OCTINOXATE, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 1.75; 1.71; 1.46 mg/35mL; mg/35mL; mg/35mL N 20181231 51346-205_3716832e-99fc-4bda-98d9-5f5052c786e9 51346-205 HUMAN OTC DRUG PROVENCE MAKEUP BASE SPF30 PA PLUS PLUS 02 LAVENDER OCTINOXATE, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 1.75; 1.71; 1.46 mg/35mL; mg/35mL; mg/35mL N 20181231 51346-206_52a08bd7-9ba8-4233-babb-eea806374bfc 51346-206 HUMAN OTC DRUG PROVENCE TWO WAY PACT SPF50PLUS PA PLUS PLUS PLUS 01 LIGHT BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.39; .72; .35 g/12g; g/12g; g/12g N 20181231 51346-207_bb824986-1cf3-4f75-bc31-11138e90228c 51346-207 HUMAN OTC DRUG PROVENCE TWO WAY PACT SPF50PLUS PA PLUS PLUS PLUS 02 NATURAL BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.39; .72; .35 g/12g; g/12g; g/12g N 20181231 51346-208_568e0f98-1f01-4aee-bcc7-7b27636cc840 51346-208 HUMAN OTC DRUG UV LOCK FLOWER DAILY POWERFUL SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, Titanium Dioxide, AVOBENZONE, OCTISALATE, Octocrylene CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 3.75; 2.12; 1.25; 1; 1 mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 51346-209_36df13ef-d0eb-4774-950f-9b8b574512a7 51346-209 HUMAN OTC DRUG UV LOCK FLOWER 3 PROOF SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 3.75; 2.5; 2.45; 1.45 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 51346-210_45d17f65-3e7f-48c7-80fd-ac8d968aa52f 51346-210 HUMAN OTC DRUG UV LOCK FLOWER MILD SUN SPF35 PA PLUS PLUS OCTINOXATE, Titanium Dioxide, Octocrylene, AVOBENZONE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTOCRYLENE; AVOBENZONE 3.75; 1.06; 1; .6 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 51346-211_c25ed23d-9124-4bc4-b7c7-42e9d9b87254 51346-211 HUMAN OTC DRUG UV LOCK FLOWER SUN SPF50PLUS PA PLUS PLUS PLUS OCTINOXATE, Titanium Dioxide, OCTISALATE SPRAY TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 2.21; 2.18; 1.47 mg/150mL; mg/150mL; mg/150mL N 20181231 51346-212_8c84b705-8735-4c7d-bedd-c66dba9d5a19 51346-212 HUMAN OTC DRUG UV LOCK FLOWER NON CHEMICAL SUN SPF50PLUS PA PLUS PLUS PLUS ZINC OXIDE, TITANIUM DIOXIDE LIQUID TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE 6.24; 1 mg/50mL; mg/50mL N 20181231 51346-213_602e7e4e-af74-43d6-bc26-cc3eef456b51 51346-213 HUMAN OTC DRUG UV LOCK FLOWER PACT SUN SPF50PLUS PA PLUS PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .61; .23; .24 g/8g; g/8g; g/8g N 20181231 51346-214_bb5f883b-755d-4a02-af69-a7cbc7c2b9b8 51346-214 HUMAN OTC DRUG UV LOCK FLOWER WATER GEL SUN SPF30 PA PLUS PLUS OCTINOXATE, OCTISALATE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE 4.8; 2.4 mg/80mL; mg/80mL N 20181231 51346-215_9af05eab-8986-4711-86f7-0f9c5d594d21 51346-215 HUMAN OTC DRUG SUPER ORIGIN CC SPF25 PA PLUS PLUS BRIGHTENING OCTINOXATE, OCTISALATE, Titanium Dioxide, AVOBENZONE, Homosalate, Octocrylene CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3.28; 2.02; 1.74; .99; .9; .45 g/45g; g/45g; g/45g; g/45g; g/45g; g/45g N 20181231 51346-216_77b8667c-4b4f-40a2-84a7-71e4c590a411 51346-216 HUMAN OTC DRUG SUPER ORIGIN CC SPF30 PA PLUS PLUS TINTED OCTINOXATE, Titanium Dioxide, OCTISALATE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 3.01; 1.73; 1.12 g/45g; g/45g; g/45g N 20181231 51346-217_778b9ba4-b542-40d5-b16d-15d3ee9e0cbf 51346-217 HUMAN OTC DRUG SUPER ORIGIN CC SPF30 PA PLUS PLUS COLOR CHANGE TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 2.86; 2.7; .9; .86 g/45g; g/45g; g/45g; g/45g N 20181231 51346-218_beb8a61f-0223-4fb0-8f58-c82ff481d4dd 51346-218 HUMAN OTC DRUG ORIGINAL POWER REFIRMING AMPOULE Allantoin LIQUID TOPICAL 20130201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN .6 mg/30mL N 20181231 51346-219_cd6fd639-16ad-44d2-9d6c-754a2ae0d9d4 51346-219 HUMAN OTC DRUG ORIGINAL POWER WHITENING AND LINELESS AMPOULE ALLANTOIN LIQUID TOPICAL 20130201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. ALLANTOIN .54 mg/30mL N 20181231 51346-220_3f9c16e6-0e3d-44ff-8163-7c565f1b7ebf 51346-220 HUMAN OTC DRUG HAND AND NATURE SANITIZER PEONY Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-221_d13b5973-0576-462f-b108-33c65136e7c7 51346-221 HUMAN OTC DRUG HAND AND NATURE SANITIZER ROSE Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-222_ac15b1e3-bcc1-450c-887d-7ebbf370b9b0 51346-222 HUMAN OTC DRUG HAND AND NATURE SANITIZER CAMELLIA Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-223_f46df080-d6cf-4d20-8278-ef1d13dfbdc0 51346-223 HUMAN OTC DRUG HAND AND NATURE SANITIZER TOMATO Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-224_a5e90bbe-2a69-498a-a4af-76fc3958bbc4 51346-224 HUMAN OTC DRUG HAND AND NATURE SANITIZER RASPBERRY Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-225_93a91172-4e3e-4010-97e4-4a381b1c196e 51346-225 HUMAN OTC DRUG HAND AND NATURE SANITIZER PEPPERMINT Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-226_895a81ae-f64d-4eeb-bb64-399661abcde5 51346-226 HUMAN OTC DRUG HAND AND NATURE SANITIZER AVOCADO Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-227_195513d1-a88f-4c64-894e-3515fd332973 51346-227 HUMAN OTC DRUG HAND AND NATURE SANITIZER GRAPE Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-228_9c93f4d2-11a7-4be3-8794-39733c25b73c 51346-228 HUMAN OTC DRUG HAND AND NATURE SANITIZER LAVENDER Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-229_34aff21f-bf53-4b33-85db-6577fcf4869b 51346-229 HUMAN OTC DRUG HAND AND NATURE SANITIZER ROSEMARY Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-230_4d00de45-be52-478f-a2da-51f5cd6a17ba 51346-230 HUMAN OTC DRUG HAND AND NATURE SANITIZER GREEN TEA Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-231_bb57f259-83f9-40ef-b9d8-f10e84b4cc79 51346-231 HUMAN OTC DRUG HAND AND NATURE SANITIZER KIWI Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-232_376e2e7a-781e-4d3a-9a12-55aacf77de87 51346-232 HUMAN OTC DRUG HAND AND NATURE SANITIZER ALMOND Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-233_3abbcad2-45f5-4c5c-bc14-b70dff9719a4 51346-233 HUMAN OTC DRUG HAND AND NATURE SANITIZER APPLE Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-234_f073fc45-0071-446a-a018-8457045f20ba 51346-234 HUMAN OTC DRUG HAND AND NATURE SANITIZER ALOE Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-235_80f5977d-fa44-4f7d-ad6c-f5b3e5a0a4ba 51346-235 HUMAN OTC DRUG HAND AND NATURE SANITIZER LEMON Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-236_6f3b2040-de09-452b-89e8-f46ab01a5918 51346-236 HUMAN OTC DRUG HAND AND NATURE SANITIZER PEACH Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-237_40974335-f247-4a7a-bcec-3abb3348d546 51346-237 HUMAN OTC DRUG HAND AND NATURE SANITIZER ORANCE Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-238_c262932d-3110-477a-9d1d-e8544528686a 51346-238 HUMAN OTC DRUG HAND AND NATURE SANITIZER GRAPEFRUIT Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-239_caa9c4a2-8bb8-48ef-a1cf-fd3afe9ea207 51346-239 HUMAN OTC DRUG HAND AND NATURE SANITIZER CALENDULA Alcohol GEL TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 16.41 mg/30mL N 20181231 51346-240_3e860f74-0b99-4d60-955a-f643d1e32123 51346-240 HUMAN OTC DRUG CALIFORNIA ALOE MILD SUN BLOCK OCTINOXATE, Titanium Dioxide, AVOBENZONE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE 3.5; 1.06; .75 mg/50mL; mg/50mL; mg/50mL N 20181231 51346-241_f2158f1b-d396-4e97-be0b-1e13c77d931d 51346-241 HUMAN OTC DRUG CALIFORNIA ALOE DAILY MOISTURE SUN BLOCK OCTINOXATE, Titanium Dioxide, AVOBENZONE, OCTISALATE, Octocrylene CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 3.75; 2.21; 1.25; 1; 1 mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 51346-242_adcf28d4-0a5f-4788-9e1c-827aa2e5b154 51346-242 HUMAN OTC DRUG CALIFORNIA ALOE POWER LASTING SUN BLOCK OCTINOXATE, Zinc Oxide, OCTISALATE, Titanium Dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE 3.5; 2.45; 2.25; 1.45 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 51346-243_267b3758-e7de-4ddf-83fb-b2c5c0b8c99f 51346-243 HUMAN OTC DRUG CALIFORNIA ALOE OIL FREE SUN BLOCK OCTINOXATE, OCTISALATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE 4.8; 2.4 mg/80mL; mg/80mL N 20181231 51346-244_f48d56d9-25fa-49b3-b6be-ff8027181215 51346-244 HUMAN OTC DRUG CALIFORNIA ALOE FRESH SUN MILK Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE 6.24; 1 mg/50mL; mg/50mL N 20181231 51346-245_424a81cf-8bb4-4ac4-9347-6cec1f84855b 51346-245 HUMAN OTC DRUG CALIFORNIA ALOE POWER LASTING SUN OCTINOXATE, OCTISALATE SPRAY TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE 3.15; 1.8 mg/150mL; mg/150mL N 20181231 51346-246_3aa9044d-4807-40c0-9a39-cdeb845829f5 51346-246 HUMAN OTC DRUG CALIFORNIA ALOE POWER LASTING SUN BLOCK OCTINOXATE, Zinc Oxide, OCTISALATE, Titanium Dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE 7; 4.9; 4.5; 2.91 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 51346-247_a6db00ba-0108-4592-81f2-2f9b85a6ef99 51346-247 HUMAN OTC DRUG BY FLOWER BB 01 LIGHT BEIGE Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 3.15; 1.4 mg/35mL; mg/35mL N 20181231 51346-248_31e3c568-a721-43bc-bc0d-b4de264ee626 51346-248 HUMAN OTC DRUG BY FLOWER BB 02 NATURAL BEIGE Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 3.15; 1.4 mg/35mL; mg/35mL N 20181231 51346-249_77b3ebc0-bee6-443e-b620-6d49f0137e5e 51346-249 HUMAN OTC DRUG SUPER ORIGIN COLLAGEN BB Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.87; 1.35; .86 g/45g; g/45g; g/45g N 20181231 51346-250_18ff9a4d-905b-4897-9de9-0ceaf4efeb72 51346-250 HUMAN OTC DRUG SUPER ORIGIN CERAMIDE BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 5.14; .65 g/45g; g/45g N 20181231 51346-251_4d52d5a7-dd56-45b6-8ac0-168f13e27560 51346-251 HUMAN OTC DRUG SUPER ORIGIN COLLAGEN WATERPROOF BB Titanium Dioxide, OCTINOXATE, Zinc Oxide, OCTISALATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE; OCTISALATE 4.58; 3.15; 2.2; 1.35 g/45g; g/45g; g/45g; g/45g N 20181231 51346-252_ad1e0292-24ef-4687-bf0d-2c2fda7f6c3f 51346-252 HUMAN OTC DRUG BOTANICAL VANILLA FOUNDATION 21 VANILLA NUDE Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 2.92; 1.4 g/35g; g/35g N 20181231 51346-253_03a3f7a3-111f-4d40-979d-67453412762c 51346-253 HUMAN OTC DRUG BOTANICAL VANILLA FOUNDATION 23 VANILLA NATURAL Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 2.92; 1.4 g/35g; g/35g N 20181231 51346-254_ceb8e785-ad10-44a0-ad23-9757bde888f4 51346-254 HUMAN OTC DRUG BOTANICAL VANILLA MAKEUP BASE 01 VANILLA GREEN Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 1.76; .7 g/35g; g/35g N 20181231 51346-255_f0036aee-fb81-41bf-a296-857aa8aa72be 51346-255 HUMAN OTC DRUG BOTANICAL VANILLA MAKEUP BASE 02 VANILLA PINK Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 1.76; .7 g/35g; g/35g N 20181231 51346-256_eb4584d5-3096-4523-8136-07a3f17701b2 51346-256 HUMAN OTC DRUG CELL BOOSTING BB 01 LIGHT BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.31; 1.14; .72 g/38g; g/38g; g/38g N 20181231 51346-257_cc50ff17-b218-4417-83d9-50315eb1c1a6 51346-257 HUMAN OTC DRUG CELL BOOSTING BB 02 NATURAL BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.31; 1.14; .72 g/38g; g/38g; g/38g N 20181231 51346-258_137afd72-5667-414c-b3ac-384be412341a 51346-258 HUMAN OTC DRUG CELL BOOSTING BB 03 SAND BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.31; 1.14; .72 g/38g; g/38g; g/38g N 20181231 51346-259_89079782-d4f3-4cb8-b4c7-746e17b47dac 51346-259 HUMAN OTC DRUG SUPER ORIGIN CUSHION COMPLETE CONTROL 21 MOIST AND BRIGHT SKIN Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .96; .9; .86 g/21; g/21; g/21 N 20181231 51346-260_7542d7f6-742e-443d-ad75-6fc5b450683b 51346-260 HUMAN OTC DRUG SUPER ORIGIN CUSHION COMPLETE CONTROL 23 MOIST AND NATURAL SKIN Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.22; .9; .87 g/21; g/21; g/21 N 20181231 51346-261_ec206b3d-4f77-4f97-bdd4-d6dbaf93f5af 51346-261 HUMAN OTC DRUG SUPER ORIGIN COTTON FINISH FOUNDATION 21 LIGHT BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.05; .9; .57 mg/30mL; mg/30mL; mg/30mL N 20181231 51346-262_8c498dce-a59a-475f-a8b7-27d4368df0bd 51346-262 HUMAN OTC DRUG SUPER ORIGIN COTTON FINISH FOUNDATION 23 NATURAL BEIGE Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.05; .9; .57 mg/30mL; mg/30mL; mg/30mL N 20181231 51346-263_1fc9010c-15a0-48e4-bee9-6318431bf1ed 51346-263 HUMAN OTC DRUG CENTELLA SCAR LIME Dimethicone OINTMENT TOPICAL 20141101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .36 g/30g N 20181231 51346-264_44499b01-cf6e-49c2-a09b-6aeff5f85726 51346-264 HUMAN OTC DRUG HAND AND NATURE SANITIZER HONEY Alcohol GEL TOPICAL 20140106 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 15.67 mg/30mL N 20181231 51346-265_5491b6ba-22f3-4d66-a437-d8ebc78298ad 51346-265 HUMAN OTC DRUG HAND AND NATURE SANITIZER WHITE MUSK Alcohol GEL TOPICAL 20140106 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 15.67 mg/30mL N 20181231 51346-266_d4a0fcab-46c0-49da-93b4-efa6a952dad5 51346-266 HUMAN OTC DRUG HAND AND NATURE SANITIZER JASMINE Alcohol GEL TOPICAL 20140106 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 15.67 mg/30mL N 20181231 51346-267_e3b761a1-a838-4d4a-93a0-2ba41ed0a6fd 51346-267 HUMAN OTC DRUG HAND AND NATURE SANITIZER APPLE MANGO Alcohol GEL TOPICAL 20140106 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 15.67 mg/30mL N 20181231 51346-268_5f962bfe-60d8-4b50-b214-9616fd279b3b 51346-268 HUMAN OTC DRUG HAND AND NATURE SANITIZER ACACIA Alcohol GEL TOPICAL 20140106 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 15.67 mg/30mL N 20181231 51346-269_5419d7b0-3b65-4e06-bb16-f652764709eb 51346-269 HUMAN OTC DRUG HAND AND NATURE SANITIZER CHERRY BLOSSOM Alcohol GEL TOPICAL 20140106 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 15.67 mg/30mL N 20181231 51346-270_da685b3f-fa07-479e-a4ba-1651573b648e 51346-270 HUMAN OTC DRUG SUPER ORIGIN COLLAGEN BB SAND BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.87; 1.35; .86 g/45g; g/45g; g/45g N 20181231 51346-271_dda8fdb8-4af1-4a88-b129-55ab9e13edee 51346-271 HUMAN OTC DRUG NATURE ORIGIN CUSHION CC NATURAL NO.21 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.09; .67; .4 g/10g; g/10g; g/10g N 20181231 51346-272_d1d47c68-658e-4f28-983e-b706e6af2974 51346-272 HUMAN OTC DRUG NATURE ORIGIN CUSHION CC NATURAL NO.23 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.09; .67; .4 g/10g; g/10g; g/10g N 20181231 51346-273_92077909-4dcf-40cf-b27e-5d3728c99f24 51346-273 HUMAN OTC DRUG CELL BOOSTING ESSENTIAL SKIN Witch Hazel CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .12 mg/120mL N 20181231 51346-274_fee21d74-97da-47b1-ba28-ad8bb544c579 51346-274 HUMAN OTC DRUG CELL BOOSTING Dimethicone EMULSION TOPICAL 20141101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.2 mg/120mL N 20181231 51346-275_d95138f0-0770-49fd-962e-c0f7c27db404 51346-275 HUMAN OTC DRUG CELL BOOSTING ESSENCE Dimethicone CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .4 mg/40mL N 20181231 51346-276_8b1aebe9-2f4f-48e3-a65b-a25c829daa3a 51346-276 HUMAN OTC DRUG CELL BOOSTING Dimethicone CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .82 mg/55mL N 20181231 51346-277_24c6bdb6-ea67-42e2-8a1c-2d871cb39e74 51346-277 HUMAN OTC DRUG CELL BOOSTING NIGHT Dimethicone CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .55 mg/55mL N 20181231 51346-278_6c3612b0-dc2f-4763-92d1-df69e548d861 51346-278 HUMAN OTC DRUG CELL BOOSTING EYE Dimethicone CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .25 mg/25mL N 20181231 51346-279_32380706-73ce-46ef-95c8-997d1a2f401e 51346-279 HUMAN OTC DRUG Aqua Collagen Coenzyme Q10 Hydro Mask ADENOSINE PATCH TOPICAL 20150201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. ADENOSINE .008 g/20g N 20181231 51346-280_359f09c2-088f-455b-b153-0412b7b8b8a0 51346-280 HUMAN OTC DRUG Aqua Collagen Multi Vitamin Hydro Mask NIACINAMIDE PATCH TOPICAL 20150201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE .4 g/20g N 20181231 51346-281_7d7ce0a7-1673-4a8d-ac7f-485af1e1aa4e 51346-281 HUMAN OTC DRUG GINSENG ROYAL SILK WATERY Glycerin, Dimethicone CREAM TOPICAL 20150201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; DIMETHICONE 22.2; 1.59 g/60g; g/60g N 20181231 51346-282_c24cf4ab-b5fa-4d31-9004-89e4ce2b90e2 51346-282 HUMAN OTC DRUG PROVENCE CALENDULA AQUA COOLING SUN OCTINOXATE, OCTISALATE, ENSULIZOLE SPRAY TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; ENSULIZOLE 3.15; 1.8; 1.35 mg/150mL; mg/150mL; mg/150mL N 20181231 51346-283_c733994b-4e3f-4883-a1ea-9b128d44bf6e 51346-283 HUMAN OTC DRUG PROVENCE CALENDULA AQUA SUN OCTINOXATE, OCTISALATE, HOMOSALATE GEL TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; HOMOSALATE 3.25; 2.2; 2.2 mg/50mL; mg/50mL; mg/50mL N 20181231 51346-284_be783590-147c-4f5b-a242-d88c33f08679 51346-284 HUMAN OTC DRUG PROVENCE CALENDULA DAILY SUN BLOCK OCTINOXATE, TITANIUM DIOXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 4.27; 3.39; 1.42; 1.14; 1.14 mg/57mL; mg/57mL; mg/57mL; mg/57mL; mg/57mL N 20181231 51346-285_16f1c17f-09f9-4554-b2c4-86be779166a5 51346-285 HUMAN OTC DRUG PROVENCE CALENDULA FRESH SUN OCTINOXATE, OCTISALATE GEL TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE 3.42; 1.71 mg/57mL; mg/57mL N 20181231 51346-286_01a4b19f-5237-4748-b6ad-5ee0b12d4601 51346-286 HUMAN OTC DRUG PROVENCE CALENDULA MILD SUN BLOCK OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.87; 2.56; .67 mg/57mL; mg/57mL; mg/57mL N 20181231 51346-287_b45e69c0-8447-4507-b2c0-53bcfc686cdd 51346-287 HUMAN OTC DRUG PROVENCE CALENDULA SUN ZINC OXIDE, TITANIUM DIOXIDE LIQUID TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE 6.24; 1 mg/50mL; mg/50mL N 20181231 51346-288_a7fe7044-5dc2-4eff-89bc-55b9cfa8b2a3 51346-288 HUMAN OTC DRUG PROVENCE CALENDULA NO SEBUM SUN BLOCK OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, OCTISALATE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE; OCTISALATE 3.87; 2.95; 2.85; 2.56 mg/57mL; mg/57mL; mg/57mL; mg/57mL N 20181231 51346-289_5b12a7c5-9aa0-43a5-afdd-9789911d4aaf 51346-289 HUMAN OTC DRUG PROVENCE CALENDULA PERFECT SUN BLOCK OCTINOXATE, TITANIUM DIOXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 11.25; 6.37; 3.75; 3; 3 mg/150mL; mg/150mL; mg/150mL; mg/150mL; mg/150mL N 20181231 51346-290_d7ff1c3f-701d-4bb4-bcd6-8f6ec1bbe9f4 51346-290 HUMAN OTC DRUG PROVENCE CALENDULA WATERPROOF SUN BLOCK ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 7.87; 3.87; 3.22; 2.56 mg/57mL; mg/57mL; mg/57mL; mg/57mL N 20181231 51346-291_434fbbb3-0e55-4814-b3d9-59186b174e63 51346-291 HUMAN OTC DRUG PURE BB 21 LIGHT BEIGE TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 1.14; .9; .3; .28 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 51346-292_733595e4-270d-4516-a96d-80c053d0788e 51346-292 HUMAN OTC DRUG PURE BB 23 LIGHT BEIGE TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 1.14; .9; .3; .28 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 51346-293_49a6d4e9-72d2-463c-b3b7-cd3e549055fa 51346-293 HUMAN OTC DRUG PURE COLOR 01 BRIGHT PINK OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .9; .8 mg/15mL; mg/15mL N 20181231 51346-294_bcecbdbf-af03-45fe-9506-add14f8b9831 51346-294 HUMAN OTC DRUG PURE COLOR 02 NATURAL BEIGE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .9; .8 mg/15mL; mg/15mL N 20181231 51346-295_3b7e6dfb-8d1e-4589-aeee-0c16be64d51e 51346-295 HUMAN OTC DRUG PURE FOUNDATION 21 PINK BEIGE TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.63; .86 mg/15mL; mg/15mL N 20181231 51346-296_ee82d89d-4fb6-41c8-884a-a86f5fc05598 51346-296 HUMAN OTC DRUG PURE FOUNDATION 23 NATURAL BEIGE TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.63; .86 mg/15mL; mg/15mL N 20181231 51346-297_65b7cc2c-2b0f-4c93-a713-3aff043f34e1 51346-297 HUMAN OTC DRUG SNAIL SPECIAL SET DIMETHICONE CREAM TOPICAL 20150201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.04 mg/55mL N 20181231 51346-298_6e83967e-8f36-487a-a431-85d3f3464e74 51346-298 HUMAN OTC DRUG SNAIL DIMETHICONE EMULSION TOPICAL 20150201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.3 mg/120mL N 20181231 51346-299_3ff3fd69-028b-4e60-ac0f-4fae5d54afaf 51346-299 HUMAN OTC DRUG SNAIL ESSENCE DIMETHICONE CREAM TOPICAL 20150201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.07 mg/40mL N 20181231 51346-300_6be4eeb5-9646-443e-8a38-4122f5c949de 51346-300 HUMAN OTC DRUG SNAIL EYE DIMETHICONE CREAM TOPICAL 20150201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .6 mg/30mL N 20191231 51346-301_3f6b0564-ba95-4f11-925e-fe010a274637 51346-301 HUMAN OTC DRUG SNAIL SKIN BOOSTER NIACINAMIDE, ADENOSINE CREAM TOPICAL 20150201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE 2.4; .04 mg/120mL; mg/120mL N 20181231 51346-302_afc012f1-535a-4d36-8139-130d53089071 51346-302 HUMAN OTC DRUG GINSENG ROYAL SILK GOLD HYDRO MASK GLYCERIN PATCH TOPICAL 20150301 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 3.36 g/51 N 20181231 51346-303_a127d7f6-66dc-4ca2-aad0-8a55e741adbb 51346-303 HUMAN OTC DRUG GINSENG ROYAL SILK GOLD HYDRO MASK 10EA GLYCERIN PATCH TOPICAL 20150301 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 3.36 g/101 N 20181231 51346-304_e566008b-df1d-4f0d-a3f9-81954ccfaa36 51346-304 HUMAN OTC DRUG BY FLOWER LIP CARE SPF15 WHITE OCTINOXATE, OCTISALATE STICK TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE .21; .1 g/3.5g; g/3.5g N 20181231 51346-305_711acfaa-2027-4ba8-9930-89e8fd280c9f 51346-305 HUMAN OTC DRUG BY FLOWER LIP CARE SPF15 MINT OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .21; .1; .0003 g/3.5g; g/3.5g; g/3.5g N 20181231 51346-306_f4348c39-08a2-4900-8967-f4576c34197b 51346-306 HUMAN OTC DRUG BY FLOWER LIP CARE SPF15 RED OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .21; .1; .008 g/3.5g; g/3.5g; g/3.5g N 20181231 51346-307_49f9c5cd-17a7-4d91-a39e-bde5172fba10 51346-307 HUMAN OTC DRUG BY FLOWER LIP ESSENCE SPF15 OCTINOXATE, OCTISALATE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE .6; .3 mg/10mL; mg/10mL N 20181231 51346-308_04be4ff4-e9ed-465d-b819-4a9b3d77c539 51346-308 HUMAN OTC DRUG MOIST ESSENTIAL PACT 23 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .52; .42; .24 g/8.5g; g/8.5g; g/8.5g N 20181231 51346-309_5fd97481-19fa-4669-b7fd-381175fecd85 51346-309 HUMAN OTC DRUG MOIST ESSENTIAL PACT 21 LIGHT BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .52; .42; .24 g/8.5g; g/8.5g; g/8.5g N 20181231 51346-310_4317b503-050f-4ea4-8a6c-346426b50f1a 51346-310 HUMAN OTC DRUG SUPER AQUA MAX MOISTURE WATERY DIMETHICONE CREAM TOPICAL 20150601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 6.8 mg/80mL N 20181231 51346-311_8909c770-99d1-4777-935c-bf46d760c875 51346-311 HUMAN OTC DRUG SUPER AQUA MAX COMBINATION WATERY DIMETHICONE CREAM TOPICAL 20150601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.6 mg/80mL N 20181231 51346-312_0e705e04-d0a5-4036-af3c-8422bef4a2b1 51346-312 HUMAN OTC DRUG SUPER AQUA MAX FRESH WATERY GLYCERIN CREAM TOPICAL 20150601 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 1.6 mg/80mL N 20181231 51346-313_db8189ae-7147-4755-a20c-4fe5bf373063 51346-313 HUMAN OTC DRUG SNAIL GOLD HYDRO LIP NIACINAMIDE PATCH TOPICAL 20150601 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE .2 g/10g N 20181231 51346-314_a98a26f3-f48a-4cc8-bbdc-e3b483efb043 51346-314 HUMAN OTC DRUG AQUA COLLAGEN MARINE HYDRO MASK GLYCERIN PATCH TOPICAL 20150601 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 1.2 g/20g N 20181231 51346-315_509feca8-eb6b-49a1-a5b0-621d00a06666 51346-315 HUMAN OTC DRUG SNAIL HYDRO MASK GLYCERIN PATCH TOPICAL 20150601 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 1.2 g/20g N 20181231 51346-316_77644de3-8e54-4643-946c-b5dc5f1f2e76 51346-316 HUMAN OTC DRUG SNAIL GREEN CAVIAR HYDRO MASK GLYCERIN PATCH TOPICAL 20150601 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 1.2 g/20g N 20181231 51346-317_1cace619-d632-4362-97e8-145aaa844e6f 51346-317 HUMAN OTC DRUG SNAIL RED GINSENG HYDRO MASK GLYCERIN PATCH TOPICAL 20150601 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 1.2 g/20g N 20181231 51346-318_bbcfc4eb-a998-4829-9cc9-bcf1bda83f38 51346-318 HUMAN OTC DRUG SNAIL PEARL HYDRO MASK GLYCERIN PATCH TOPICAL 20150601 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 1.2 g/20g N 20181231 51346-319_92cd4771-db8e-4e0f-9cc4-7b2412f01c36 51346-319 HUMAN OTC DRUG SUPER AQUA MAX SOFT PEELING GLYCERIN GEL TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 4.65 mg/155mL N 20181231 51346-320_9e0df28b-5324-4b99-b28d-1702371a5aa9 51346-320 HUMAN OTC DRUG COTTON HAIR REMOVAL DIMETHICONE CREAM TOPICAL 20150801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .6 g/60g N 20181231 51346-321_23854ad9-c744-4cde-815c-650702d11e40 51346-321 HUMAN OTC DRUG AQUA COLLAGEN HYALURONIC ACID HYDRO MASK GLYCERIN PATCH TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 1.5 g/25g N 20181231 51346-322_da69235d-1684-4689-a997-41966e91127e 51346-322 HUMAN OTC DRUG AQUA COLLAGEN MARINE HYDRO MASK 25G GLYCERIN PATCH TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 1.5 g/25g N 20181231 51346-323_fbac25be-d014-4690-bcd4-d48b6ac29419 51346-323 HUMAN OTC DRUG COTTON ARMPIT GLYCERIN CREAM TOPICAL 20150801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 26 mg/130mL N 20181231 51346-324_60a7c767-7b8a-4d32-a436-8ec61b5c54a4 51346-324 HUMAN OTC DRUG REAL SQUEEZE ALOE VERA GLYCERIN CREAM TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 2.92 mg/50mL N 20181231 51346-325_e12f4561-c3be-4635-ba55-93572018d544 51346-325 HUMAN OTC DRUG REAL SQUEEZE ALOE VERA ESSENCE GLYCERIN CREAM TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 2.55 mg/50mL N 20181231 51346-326_02b5cb17-51e0-4330-a246-ecd73765f26a 51346-326 HUMAN OTC DRUG REAL SQUEEZE ALOE VERA GLYCERIN EMULSION TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 2.35 mg/125mL N 20181231 51346-327_80b995e4-164d-41d0-93bf-6c7ee2879896 51346-327 HUMAN OTC DRUG REAL SQUEEZE ALOE VERA TONER GLYCERIN LIQUID TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 7.81 mg/150mL N 20181231 51346-328_521900ec-a5b7-429e-903b-253f8e279c63 51346-328 HUMAN OTC DRUG REAL SQUEEZE ALOE VERA SLEEPING PACK GLYCERIN GEL TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 9.6 mg/160mL N 20181231 51346-329_80b8e16e-ce8e-4740-9812-9410eda6474d 51346-329 HUMAN OTC DRUG REAL SQUEEZE ALOE VERA ICE PACK DIMETHICONE CREAM TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. DIMETHICONE .5 mg/100mL N 20181231 51346-330_01bd4a76-6925-4d15-8b58-a0b49f14b245 51346-330 HUMAN OTC DRUG PURE VITA WHITE NIACINAMIDE LOTION TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE 2 g/100g N 20181231 51346-331_66858fa2-4d22-42b5-bd57-b23c74e9701f 51346-331 HUMAN OTC DRUG MOIST PACT NO.23 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.5; .72; .36 g/12g; g/12g; g/12g N 20181231 51346-332_009f03cf-486c-4d95-9ac9-6f0246560956 51346-332 HUMAN OTC DRUG MOIST PACT NO.21 BRIGHT BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.4; .72; .36 g/12g; g/12g; g/12g N 20181231 51346-333_cb3dcf57-e7b8-4a05-ba16-dbe0c2a55554 51346-333 HUMAN OTC DRUG SACCHAROMYCES THE FIRST EYE NIACINAMIDE CREAM TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE .5 mg/25mL N 20181231 51346-334_12236354-57e3-4a08-b120-b5311abcfab7 51346-334 HUMAN OTC DRUG SACCHAROMYCES THE FIRST NIACINAMIDE CREAM TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE 1 mg/50mL N 20181231 51346-335_373d2aa9-b634-4b9e-8134-f36b0699fe50 51346-335 HUMAN OTC DRUG HAND AND NATURE SANITIZER PEACH 250mL ALCOHOL GEL TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part333A NATURE REPUBLIC CO., LTD. ALCOHOL 130.65 mg/250mL N 20181231 51346-336_936a6b94-05ea-4771-9a5f-e5eaaace614a 51346-336 HUMAN OTC DRUG JEJU SPARKLING CLEANSING TISSUE ALLANTOIN SOLUTION TOPICAL 20150801 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. ALLANTOIN .25 g/205g N 20181231 51346-337_89533c57-221b-4299-a9b1-f1f709cca0a2 51346-337 HUMAN OTC DRUG ARGAN ESSENTIAL DEEP CARE HAIR PACK DIMETHICONE CREAM TOPICAL 20150801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 20 mg/200mL N 20181231 51346-338_24d39882-9a2e-4838-bf91-2fd0d277e7f3 51346-338 HUMAN OTC DRUG ARGAN ESSENTIAL DEEP CARE CONDITIONER DIMETHICONE SOLUTION TOPICAL 20150801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 30 mg/300mL N 20181231 51346-339_2b5a4547-8116-4d45-82fd-53e21e4611d4 51346-339 HUMAN OTC DRUG AFRICA BIRD HOMME BB MOISTURIZER OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 3.35; 2.47; 1.25 mg/50mL; mg/50mL; mg/50mL N 20181231 51346-340_5590ae53-6371-4550-ab12-7ea57e5497e5 51346-340 HUMAN OTC DRUG PURE FOUNDATION 35 TAN BROWN TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.63; .86 mg/15mL; mg/15mL N 20181231 51346-341_3f425c5d-928c-4554-85df-b538db2710f6 51346-341 HUMAN OTC DRUG PURE FOUNDATION 25 SAND BEIGE TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.63; .86 mg/15mL; mg/15mL N 20181231 51346-342_d9726faf-0bb7-432f-b242-6db982a707f2 51346-342 HUMAN OTC DRUG FRESH GREEN TEA SEED SERUM DIMETHICONE CREAM TOPICAL 20150801 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2.5 mg/50mL N 20181231 51346-343_19627a4f-a8a1-4de4-8a35-e06b4dde12e3 51346-343 HUMAN OTC DRUG GINSENG ROYAL SILK ESSENCE DIMETHICONE LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .4 mg/40mL N 20181231 51346-344_d6b91944-5fa4-4b7d-bdf5-67b3807f74bb 51346-344 HUMAN OTC DRUG GINSENG ROYAL SILK TONER NIACINAMIDE LIQUID TOPICAL 20150901 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE 2.4 mg/120mL N 20181231 51346-345_11287243-ddc7-4aff-bddf-bf3631178649 51346-345 HUMAN OTC DRUG GINSENG ROYAL SILK NIACINAMIDE EMULSION TOPICAL 20150901 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE 2.4 mg/120mL N 20181231 51346-346_a9853460-0584-4ed7-8a70-15c2d5dcc95d 51346-346 HUMAN OTC DRUG PROVENCE WATER DROP PACT 21 LIGHT BEIGE TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE POWDER TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE .89; .84; .28; .26 g/14g; g/14g; g/14g; g/14g N 20181231 51346-347_954af749-573b-4c49-9769-ea0ec0acd038 51346-347 HUMAN OTC DRUG PROVENCE WATER DROP PACT 23 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE POWDER TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE .89; .84; .28; .26 g/14g; g/14g; g/14g; g/14g N 20181231 51346-348_f743ac7f-db8c-4893-a22c-0ed2f82d7dce 51346-348 HUMAN OTC DRUG SNAIL BB 01 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.16; 1.2; .76 mg/40mL; mg/40mL; mg/40mL N 20181231 51346-349_6de89e76-f8fb-477c-a585-554990883b7e 51346-349 HUMAN OTC DRUG SNAIL BB 02 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.16; 1.2; .76 mg/40mL; mg/40mL; mg/40mL N 20181231 51346-350_fbcc9fbb-4634-47c7-9be0-28acbb2f568e 51346-350 HUMAN OTC DRUG ARGAN ESSENTIAL DEEP CARE COCAMIDOPROPYL BETAINE SHAMPOO TOPICAL 20150901 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. COCAMIDOPROPYL BETAINE 72 mg/300mL N 20181231 51346-351_ab679f4e-b668-480e-b121-4ceda56a0f5e 51346-351 HUMAN OTC DRUG GREENTINOL MULTI TONER NIACINAMIDE SOLUTION TOPICAL 20151001 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE 2.85 mg/150mL N 20181231 51346-352_72f02704-b1dd-4083-863a-43b4c3f5f57c 51346-352 HUMAN OTC DRUG GREENTINOL Dimethicone CREAM TOPICAL 20151001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .83 mg/50mL N 20181231 51346-353_9c5b6c66-77db-4eb5-853a-b675825f7a16 51346-353 HUMAN OTC DRUG GREENTINOL ESSENCE DIMETHICONE CREAM TOPICAL 20151001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.63 mg/40mL N 20181231 51346-354_945fe381-695e-4857-88ef-0c875ef5c273 51346-354 HUMAN OTC DRUG SHEA BUTTER STEAM ULTRA Dimethicone CREAM TOPICAL 20151001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1 mg/100mL N 20181231 51346-355_81ca40f3-d9e8-4241-86dc-87b1599ab6c6 51346-355 HUMAN OTC DRUG SHEA BUTTER STEAM MOIST Glycerin CREAM TOPICAL 20151001 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 10 mg/100mL N 20181231 51346-356_8ba299fc-4371-47e6-a176-01411d864ea3 51346-356 HUMAN OTC DRUG SHEA BUTTER STEAM FRESH Glycerin CREAM TOPICAL 20151001 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 15 mg/100mL N 20181231 51346-357_87496b08-b87c-4b94-9fa5-1fbbb6b8e555 51346-357 HUMAN OTC DRUG NATURE ORIGIN CC BRIGHTENING Octinoxate, Titanium Dioxide, Octisalate CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 3.01; 1.6; 1.12 g/45g; g/45g; g/45g N 20181231 51346-358_25f81177-a314-420d-b6fc-d75ec4d59773 51346-358 HUMAN OTC DRUG NATURE ORIGIN CC TINTED Octinoxate, Titanium Dioxide, Octisalate CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 3.01; 1.72; 1.12 g/45g; g/45g; g/45g N 20181231 51346-359_0459a728-b722-4e55-a2f2-f1853a013077 51346-359 HUMAN OTC DRUG NATURE ORIGIN CC BLUR Octinoxate, Titanium Dioxide, Octisalate CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 3.01; 2.7; 1.12 g/45g; g/45g; g/45g N 20181231 51346-360_d870ed9d-8dfe-45b1-b5a1-8c8129772255 51346-360 HUMAN OTC DRUG GINSENG ROYAL SILK GOLD HYDRO MASK 1EA Glycerin PATCH TOPICAL 20151001 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 3.36 mg/32mL N 20181231 51346-361_3695cefe-ccd4-4ef5-b05a-eb6206765032 51346-361 HUMAN OTC DRUG NATURE ORIGIN COLLAGEN BB 01 LIGHT BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.87; 1.35; .86 g/45g; g/45g; g/45g N 20181231 51346-362_260249ae-9fe4-4482-b42d-376e8ae3c224 51346-362 HUMAN OTC DRUG NATURE ORIGIN COLLAGEN BB 02 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.87; 1.35; .86 g/45g; g/45g; g/45g N 20181231 51346-363_7fabf404-fb8f-4c33-99d3-c707bc8da201 51346-363 HUMAN OTC DRUG NATURE ORIGIN COLLAGEN BB ORIGINAL TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.87; 1.35; .86 g/45g; g/45g; g/45g N 20181231 51346-364_3367f6e7-8f6f-400c-8da6-472029a4aa32 51346-364 HUMAN OTC DRUG BEE VENOM TONER Glycerin SOLUTION TOPICAL 20151001 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 8.13 mg/150mL N 20181231 51346-365_62772968-278d-4955-9182-3d372cbb5df7 51346-365 HUMAN OTC DRUG BEE VENOM TREATMENT SPOT GLYCERIN CREAM TOPICAL 20151001 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 1.21 mg/30mL N 20181231 51346-366_714bf477-353d-4afc-9639-84055f81e88c 51346-366 HUMAN OTC DRUG GINSENG ROYAL SILK EYE Glycerin CREAM TOPICAL 20151001 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 1.25 mg/25mL N 20181231 51346-367_1940c720-80bc-467a-9c27-c81df0755765 51346-367 HUMAN OTC DRUG BEE VENOM Glycerin EMULSION TOPICAL 20151001 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 9.6 mg/120mL N 20181231 51346-368_659cc1c3-778d-4ead-ab3f-b53e51605d15 51346-368 HUMAN OTC DRUG BEE VENOM CLEANSING FOAM Glycerin SOLUTION TOPICAL 20151001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 41.85 mg/150mL N 20181231 51346-369_ce553e80-fa91-4c58-8434-da6dcb39ba14 51346-369 HUMAN OTC DRUG WHITE VITA FLORAL NIACINAMIDE EMULSION TOPICAL 20151101 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE 3 g/150mL N 20181231 51346-370_e9ca75da-6235-4aaf-9701-a06d445a3838 51346-370 HUMAN OTC DRUG WHITE VITA FLORAL MOISTURE DIMETHICONE CREAM TOPICAL 20151101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.12 g/50mL N 20181231 51346-371_f2cfd58a-3467-4cf7-b686-652169fdd231 51346-371 HUMAN OTC DRUG WHITE VITA FLORAL TONER NIACINAMIDE LIQUID TOPICAL 20151101 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE 3 g/150mL N 20181231 51346-372_fc4e8118-d9ed-4c17-b66c-52dde14e02e1 51346-372 HUMAN OTC DRUG AQUA COLLAGEN MARINE HYDRO LIP GLYCERIN PATCH TOPICAL 20151101 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN .8 g/8g N 20181231 51346-373_919039b2-e952-4967-8e91-a2c4516caef7 51346-373 HUMAN OTC DRUG WHITE VITA FLORAL ESSENCE BRIGHTENING NIACINAMIDE CREAM TOPICAL 20151201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE 2 g/40mL N 20181231 51346-374_0464cafd-6782-4ab1-a227-1cf656dcbefd 51346-374 HUMAN OTC DRUG CELL BOOSTING BB SPF30 01 LIGHT BEIGE Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.79; .96; .61 g/32mL; g/32mL; g/32mL N 20181231 51346-375_18e54a74-d716-4a1d-807a-1600c9af2e39 51346-375 HUMAN OTC DRUG CELL BOOSTING BB SPF30 02 NATURAL BEIGE Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.79; .96; .61 g/32mL; g/32mL; g/32mL N 20181231 51346-376_e84d5164-5438-4784-8b27-f1ab73c95b69 51346-376 HUMAN OTC DRUG CELL BOOSTING BB SPF30 07 SAND BEIGE Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.79; .96; .61 g/32mL; g/32mL; g/32mL N 20181231 51346-377_1eafd881-0b27-40f8-9441-c95d31d3b038 51346-377 HUMAN OTC DRUG BOTANICAL GREEN TEA PORE BB 01 LIGHT BEIGE Titanium Dioxide, Octinoxate, Zinc Oxide, Octisalate CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE; OCTISALATE 2.68; 2.45; 1.71; 1.57 g/35g; g/35g; g/35g; g/35g N 20181231 51346-378_d3e1b5c4-207f-4c49-9ecc-5c1b3ae9c042 51346-378 HUMAN OTC DRUG BOTANICAL GREEN TEA PORE BB 02 NATURAL BEIGE Titanium Dioxide, Octinoxate, Zinc Oxide, Octisalate CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE; OCTISALATE 2.68; 2.45; 1.71; 1.57 g/35g; g/35g; g/35g; g/35g N 20181231 51346-379_ad2dd39c-f49b-477d-88e3-d2cfbafde9ec 51346-379 HUMAN OTC DRUG GREENTINOL EYE SERUM GLYCERIN CREAM TOPICAL 20160302 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 1.07 g/20mL N 20181231 51346-380_c2f45042-ca95-409b-839f-e515fec258f0 51346-380 HUMAN OTC DRUG WHITE VITA FIRST ESSENCE NIACINAMIDE CREAM TOPICAL 20160302 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE 3 g/150mL N 20181231 51346-381_0646339e-e1cf-4268-bc9c-2bf4f78c108d 51346-381 HUMAN OTC DRUG WHITE VITA FLORAL EYE BRIGHTNER DIMETHICONE CREAM TOPICAL 20160302 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .32 g/30mL N 20181231 51346-382_e14db5f6-91fc-44fe-bd85-55cf028fdbc5 51346-382 HUMAN OTC DRUG GREEK YOGURT PACK ORANGE GLYCERIN CREAM TOPICAL 20160302 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 11.7 g/130mL N 20181231 51346-383_b32757de-b3d5-4f30-9473-7aa094f1450b 51346-383 HUMAN OTC DRUG GREEK YOGURT PACK BLUE BERRY GLYCERIN CREAM TOPICAL 20160302 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 6.5 g/130mL N 20181231 51346-384_b5bf4432-81e7-42a8-bf1e-e89950484d98 51346-384 HUMAN OTC DRUG GINSENG ROYAL SILK AMPOULE Glycerin, Niacinamide SOLUTION TOPICAL 20160501 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN; NIACINAMIDE 1.1; .34 g/17mL; g/17mL N 20181231 51346-385_08627b3c-ea86-4f7d-b1df-f005e8fb0902 51346-385 HUMAN OTC DRUG PROVENCE CALENDULA ICE PUFF SUN Titanium Dioxide, Octinoxate, Zinc Oxide, Octisalate SPRAY TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE; OCTISALATE 7.4; 7.5; 5.64; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 51346-386_f64e601a-a315-453c-a1c5-43d9a4dc8d23 51346-386 HUMAN OTC DRUG PROVENCE CALENDULA PERFECT SUN BLOCK 150mL Octinoxate, Homosalate, Octisalate CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; HOMOSALATE; OCTISALATE 10.5; 9; 6.75 g/150mL; g/150mL; g/150mL N 20181231 51346-387_6ad7d550-6ac0-4fcc-95cc-a2ccd259db37 51346-387 HUMAN OTC DRUG LOVE YOU BABY SUN CUSHION Titanium Dioxide, Octinoxate, Zinc Oxide POWDER TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .48; .9; .33 g/12g; g/12g; g/12g N 20181231 51346-389_a66409c0-77e4-454a-a725-80d39f2a2b01 51346-389 HUMAN OTC DRUG PROVENCE CALENDULA AQUA SUN 35g Octinoxate, Octocrylene, Octisalate, AVOBENZONE GEL TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 2.45; 1.75; 1.57; 1.4 g/35g; g/35g; g/35g; g/35g N 20181231 51346-390_248e18fb-1c77-4675-a5f6-fc790039d6c2 51346-390 HUMAN OTC DRUG NATURAL OLIVE SCALP COOLING HAIR ESSENCE Glycerin SPRAY TOPICAL 20160501 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN .5 g/100mL N 20181231 51346-391_bdd4f9ff-2299-4d8c-b467-b5ff1dada02d 51346-391 HUMAN OTC DRUG NATURAL OLIVE SCALP COOLING HAIR PACK GLYCERIN GEL TOPICAL 20160501 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 10 g/200mL N 20181231 51346-392_255e4585-5681-4ff9-86f9-f1f16771b603 51346-392 HUMAN OTC DRUG PURE SHINE VANILLA MAKEUP BASE 01 VANILA GREEN Titanium Dioxide, Octinoxate CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 1.76; .7 g/35g; g/35g N 20181231 51346-393_9b6d10f3-6da6-4edc-a14b-9bb56eed4e81 51346-393 HUMAN OTC DRUG PURE SHINE VANILLA MAKEUP BASE 02 VANILA PINK Titanium Dioxide, Octinoxate CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 1.76; .7 g/35g; g/35g N 20181231 51346-394_793a129a-4515-4876-8fd1-3b0eaa0839dc 51346-394 HUMAN OTC DRUG PURE SHINE COVER BB 01 PINK BEIGE Titanium Dioxide, Octinoxate CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 3.15; 1.4 g/35g; g/35g N 20181231 51346-395_7cc008c0-fb0d-4508-bd22-707501103ef7 51346-395 HUMAN OTC DRUG PURE SHINE COVER BB 02 NATURAL BEIGE Titanium Dioxide, Octinoxate CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 3.15; 1.4 g/35g; g/35g N 20181231 51346-396_2137b431-7288-41ce-98aa-fa3ad6775a26 51346-396 HUMAN OTC DRUG SNAIL SOLU TION BB 07 SAND BEIGE Titanium Dioxide, Octinoxate CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 3.16; 1.2 g/40mL; g/40mL N 20181231 51346-397_989906cd-a9ce-4d9b-9174-9d3a419d34cd 51346-397 HUMAN OTC DRUG SNAIL SOLU TION SLEEPING MASK DIMETHICONE GEL TOPICAL 20160501 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.6 g/100mL N 20181231 51346-398_2e9c0950-f1ef-4a83-915a-472bc9a9c758 51346-398 HUMAN OTC DRUG SNAIL SOLU TION Dimethicone CREAM TOPICAL 20161101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .99 g/55mL N 20181231 51346-399_d9fd9727-1974-4dba-ae06-71a2358d1f15 51346-399 HUMAN OTC DRUG CELL BOOSTING WATERY Dimethicone CREAM TOPICAL 20161101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.65 g/55mL N 20181231 51346-400_1368fcce-5ae8-401d-9ad3-4ad0d3715715 51346-400 HUMAN OTC DRUG GINSENG ROYAL SILK FO AM CLEANSER Glycerin GEL TOPICAL 20161101 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN 41.85 g/150mL N 20181231 51346-401_5f3e3d4e-5361-4f05-82bf-b91204efc079 51346-401 HUMAN OTC DRUG PROVENCE AIR SKIN FIT FOUNDATION W01 LIGHT BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.24; .9; .57 g/30mL; g/30mL; g/30mL N 20181231 51346-402_3865ad63-1ab8-4d33-9d27-9063f9888fa8 51346-402 HUMAN OTC DRUG PROVENCE AIR SKIN FIT FOUNDATION W02 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.24; .9; .57 g/30mL; g/30mL; g/30mL N 20181231 51346-403_827f91db-7738-4c96-9280-f6aa6465c3a5 51346-403 HUMAN OTC DRUG PROVENCE AIR SKIN FIT FOUNDATION PINK BEIGE C01 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.24; .9; .57 g/30mL; g/30mL; g/30mL N 20181231 51346-404_21967dcc-604f-44ab-9e29-7259df89bbf4 51346-404 HUMAN OTC DRUG PROVENCE AIR SKIN FIT FOUNDATION GINGER BEIGE C02 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.24; .9; .57 g/30mL; g/30mL; g/30mL N 20181231 51346-405_cc0d2a8a-81f3-4152-b91d-0cf1298767bc 51346-405 HUMAN OTC DRUG PROVENCE AIR SKIN FIT MAKE UP BASE 01 PINK OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 2.01; 1.08; .75 g/30mL; g/30mL; g/30mL N 20181231 51346-406_c09262ab-8003-4dfd-ad97-f0563605935f 51346-406 HUMAN OTC DRUG PROVENCE AIR SKIN FIT MAKE UP BASE 02 GREEN OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 2.01; 1.08; .75 g/30mL; g/30mL; g/30mL N 20181231 51346-407_46feb26b-d80f-4340-9811-a775a0934541 51346-407 HUMAN OTC DRUG SUPER ORIGIN COLLAGEN WATERPROOF BB 45g Titanium Dioxide, Octinoxate, Zinc Oxide, Octisalate CREAM TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE; OCTISALATE 4.58; 3.15; 2.2; 1.35 g/45g; g/45g; g/45g; g/45g N 20181231 51346-408_9a083eef-2dd9-495b-8a23-4adcaaa17b05 51346-408 HUMAN OTC DRUG AQUA COLLAGEN SOLU TION MARINE HYDROGE L EYE CREA M MASK Glycerin, Niacinamide PATCH TOPICAL 20161101 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN; NIACINAMIDE .96; .16 g/8g; g/8g N 20181231 51346-409_6a703106-1df1-4195-be61-34fcbe66a4e7 51346-409 HUMAN OTC DRUG BEE VENOM MIST ESSENCE BEE VENOM AEROSOL, SPRAY TOPICAL 20161201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. APIS MELLIFERA VENOM .98 g/100mL N 20181231 51346-410_b6fce871-fe2b-424e-b231-2ef2d02a49e3 51346-410 HUMAN OTC DRUG SNAIL SOLU TION MASK SHEET WITCH HAZEL PATCH TOPICAL 20161201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. WITCH HAZEL .02 g/20g N 20181231 51346-411_d9361c36-4156-4042-8540-2b2b02da5481 51346-411 HUMAN OTC DRUG SNAIL GLYCERIN CREAM TOPICAL 20161201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 9 g/75mL N 20181231 51346-412_dac73e01-21e2-4bee-92d1-3be676fb499d 51346-412 HUMAN OTC DRUG SNAIL SOLU TION GOLD GLYCERIN, DIMETHICONE CREAM TOPICAL 20161201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. GLYCERIN; DIMETHICONE 15.96; 1.26 g/55mL; g/55mL N 20181231 51346-413_db65870e-fa1d-410a-ac5e-91e21312d4c0 51346-413 HUMAN OTC DRUG GINSENG ROYAL SILK WRINKLE UP SPOT Niacinamide, Adenosine CREAM TOPICAL 20161220 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE .13; .002 g/6.5mL; g/6.5mL N 20181231 51346-414_cfd38bbf-c951-44cd-8bb7-bd60dc6ae10f 51346-414 HUMAN OTC DRUG PROVENCE INTENSIVE AMPOULE BB 01 LIGHT BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.37; .9; .57 g/30mL; g/30mL; g/30mL N 20181231 51346-415_736ad5d9-4a32-48bd-b0e8-ebd6d53b2685 51346-415 HUMAN OTC DRUG PROVENCE INTENSIVE AMPOULE BB 02 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.37; .9; .57 g/30mL; g/30mL; g/30mL N 20181231 51346-416_20205c98-1fc7-4f02-9d80-3a9312130bab 51346-416 HUMAN OTC DRUG White Mineral Homme Toner Niacinamide LIQUID TOPICAL 20161220 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE 2.8 g/140mL N 20181231 51346-417_30a7e45b-f50e-4727-9e58-5375e4cb0752 51346-417 HUMAN OTC DRUG White Mineral Homme Fluid Niacinamide EMULSION TOPICAL 20161220 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE 2.8 g/140mL N 20181231 51346-418_c1c59899-03e8-4f90-86cb-d60d74f3dd2e 51346-418 HUMAN OTC DRUG White Mineral Homme Fo am Cleanser Niacinamide GEL TOPICAL 20161220 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE 2 g/100mL N 20181231 51346-419_71ced308-084d-4bee-8866-40d3328dd82e 51346-419 HUMAN OTC DRUG GINSENG ROYAL SILK CAP SULE ESSENCE Niacinamide, Adenosine CREAM TOPICAL 20161220 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE .8; .016 g/40mL; g/40mL N 20181231 51346-420_8f906071-4723-4598-bfd8-ef2544c6f50c 51346-420 HUMAN OTC DRUG PROVENCE INTENSIVE AMPOULE MAKE UP BASE 02 LAVENDER Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 1.5; 1.47; 1.23 g/30mL; g/30mL; g/30mL N 20181231 51346-421_6e5bbd9a-3afc-403f-bdba-dfae71c884b5 51346-421 HUMAN OTC DRUG PROVENCE INTENSIVE AMPOULE FOUNDATION 01 LIGHT BEIGE Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.82; 1.2; .27 g/30mL; g/30mL; g/30mL N 20181231 51346-422_05388c53-40cf-4056-afc1-f9a3a422aa16 51346-422 HUMAN OTC DRUG GINSENG ROYAL SILK BOOSTING AMPOULE Niacinamide, Adenosine SOLUTION/ DROPS TOPICAL 20161220 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE .6; .012 g/30mL; g/30mL N 20181231 51346-423_77e733a9-a562-4595-834d-8d20b1843710 51346-423 HUMAN OTC DRUG GINSENG ROYAL SILK AMPOULE 17mL 4ea NIACINAMIDE, ADENOSINE SOLUTION TOPICAL 20161210 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE .34; .006 g/17mL; g/17mL N 20181231 51346-424_ad13a8f3-7699-49ce-b3d1-70e2d728a764 51346-424 HUMAN OTC DRUG GINSENG ROYAL SILK WATERY 60G NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161210 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE 1.2; .024 g/60g; g/60g N 20181231 51346-425_698fa1ef-d722-40a8-8b3e-d1686429b625 51346-425 HUMAN OTC DRUG GINSENG ROYAL SILK GOLD HYDROGE L MASK NIACINAMIDE, ADENOSINE PATCH TOPICAL 20161210 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE .64; .012 g/32mL; g/32mL N 20181231 51346-426_f36bc29f-c470-4f5f-bc13-2f2b2d4a04ff 51346-426 HUMAN OTC DRUG GINSENG ROYAL SILK GOLD HYDROGE L MASK 5P NIACINAMIDE, ADENOSINE PATCH TOPICAL 20161210 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE .64; .012 g/32mL; g/32mL N 20181231 51346-427_72287833-9713-4bcc-9b76-b3904007aea0 51346-427 HUMAN OTC DRUG GINSENG ROYAL SILK GOLD HYDROGE L MASK 10P NIACINAMIDE, ADENOSINE PATCH TOPICAL 20161210 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE .64; .012 g/32mL; g/32mL N 20181231 51346-428_8a46839c-7521-4cf3-b790-e77b311816e1 51346-428 HUMAN OTC DRUG GINSENG ROYAL SILK TONER 120ML NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20161201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE 2.4; .048 g/120mL; g/120mL N 20181231 51346-429_f85d0537-3505-46a4-9085-79732ea770bf 51346-429 HUMAN OTC DRUG GINSENG ROYAL SILK 120ML NIACINAMIDE, ADENOSINE EMULSION TOPICAL 20161201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE 2.4; .048 g/120mL; g/120mL N 20181231 51346-430_dd48ed6f-28a6-49c9-b005-a317c3fe21e5 51346-430 HUMAN OTC DRUG GINSENG ROYAL SILK EYE 25ML NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE .5; .01 g/25mL; g/25mL N 20181231 51346-431_70ba305c-dd86-4b4c-9f30-06d282fd5198 51346-431 HUMAN OTC DRUG SNAIL SOLU TION WRINKLE UP SPOT NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE .3; .006 g/15mL; g/15mL N 20181231 51346-432_b5bf8641-84d7-41f1-8245-1523ac354c4d 51346-432 HUMAN OTC DRUG COLLAGEN DREAM 50 RADIANCE ALL IN ONE TONE UP Octinoxate, Titanium Dioxide, Octocrylene CREAM TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTOCRYLENE 3.75; 2.36; 1 g/50mL; g/50mL; g/50mL N 20181231 51346-433_cc3b890e-823f-4eb6-a857-4b746886df9f 51346-433 HUMAN OTC DRUG PROVENCE CALENDULA AQUA SUN Octinoxate, Octinoxate STICK TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE 1.05; .67 g/15g; g/15g N 20181231 51346-434_eac829b0-089d-4b8c-b9aa-7198a1abb8ab 51346-434 HUMAN OTC DRUG VITAMIN B5 TONER Glycerin LIQUID TOPICAL 20161201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 2.59 g/150mL N 20181231 51346-435_1c26811a-3ec6-47ce-895f-63decceab97a 51346-435 HUMAN OTC DRUG VITAMIN B5 Dimethicone EMULSION TOPICAL 20161201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.5 g/150mL N 20181231 51346-436_f1c6ae79-6927-42bc-a2ab-e7e025796aed 51346-436 HUMAN OTC DRUG VITAMIN B5 ESSENCE Dimethicone CREAM TOPICAL 20161201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.57 g/35mL N 20181231 51346-437_7915bf31-01c5-4b0b-88f2-c94e35ea48d8 51346-437 HUMAN OTC DRUG VITAMIN B5 Glycerin CREAM TOPICAL 20161201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. GLYCERIN 3.43 g/50mL N 20181231 51346-438_644d91a3-2fe3-4af5-8ac9-8965ccd6e278 51346-438 HUMAN OTC DRUG PROVENCE AIR SKIN FIT PACT 01 LIGHT BEIGE TITANIUM DIOXIDE POWDER TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE .24 g/10g N 20181231 51346-439_74b13f4f-82e6-4fcc-895c-0f6a10a41f1d 51346-439 HUMAN OTC DRUG PROVENCE AIR SKIN FIT PACT 02 NATURAL BEIGE ZINC OXIDE, OCTINOXATE, OCTISALATE POWDER TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. ZINC OXIDE; OCTINOXATE; OCTISALATE .48; .37; .25 g/10g; g/10g; g/10g N 20181231 51346-440_079a4861-9538-4b3a-9810-d6a3d5e63483 51346-440 HUMAN OTC DRUG PROVENCE AIR SKIN FIT BLUR PACT Titanium Dioxide, Octinoxate, Zinc Oxide POWDER TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .74; .6; .35 g/12g; g/12g; g/12g N 20181231 51346-441_ee45efe3-91c4-49a9-8020-8b4e08ac2840 51346-441 HUMAN OTC DRUG SNAIL SOLU TION SKIN BOOSTER NIACINAMIDE, ADENOSINE CREAM TOPICAL 20150201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE 2.4; .04 g/120mL; g/120mL N 20181231 51346-442_6e33bc6a-7294-45cb-8a4a-2f3ad12ba10d 51346-442 HUMAN OTC DRUG SNAIL SOLU TION DIMETHICONE EMULSION TOPICAL 20161220 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1.3 g/120mL N 20181231 51346-443_bd940986-990d-4ba4-becb-1b9038967941 51346-443 HUMAN OTC DRUG SNAIL SOLU TION ESSENCE DIMETHICONE CREAM TOPICAL 20161220 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. DIMETHICONE 1.07 g/40mL N 20181231 51346-444_af2fdf1a-7c62-4156-b9ef-eb61ba13023e 51346-444 HUMAN OTC DRUG SNAIL SOLU TION EYE DIMETHICONE CREAM TOPICAL 20150201 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .6 g/30mL N 20181231 51346-445_396f8e77-e654-4967-b1c2-46194ede2be8 51346-445 HUMAN OTC DRUG SHEA BUTTER STEAM CRE AM MOIST Dimethicone CREAM TOPICAL 20151001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1 g/100mL N 20181231 51346-446_69d8dae2-48f6-422b-97f0-0238ecdbc792 51346-446 HUMAN OTC DRUG SHEA BUTTER STEAM CRE AM FRESH Dimethicone CREAM TOPICAL 20151001 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 1 g/100mL N 20181231 51346-447_8c9f17ed-e694-4c87-b0e2-82ef106d6e21 51346-447 HUMAN OTC DRUG PROVENCE CALENDULA MILD SUN BLOCK SPF35 octinoxate, octisalate, titanium dioxide CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.87; 2.56; .67 g/57mL; g/57mL; g/57mL N 20181231 51346-448_96e25a91-0949-4060-8e65-71de3ba9f29f 51346-448 HUMAN OTC DRUG PROVENCE CALENDULA NO SEBUM SUN BLOCK SPF45 octinoxate, titanium dioxide, zinc oxide, octisalate CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE; OCTISALATE 3.87; 2.95; 2.85; 2.56 g/57mL; g/57mL; g/57mL; g/57mL N 20181231 51346-449_4d99701a-827b-4119-bad2-c7223c4ae4ff 51346-449 HUMAN OTC DRUG PROVENCE CALENDULA AQUA SUN GE L Octinoxate, Octocrylene, Octisalate, AVOBENZONE GEL TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 4.2; 3; 2.7; 2.4 g/60mL; g/60mL; g/60mL; g/60mL N 20181231 51346-450_e03f4c9a-84c4-4b25-b307-49abd44a4817 51346-450 HUMAN OTC DRUG PROVENCE CALENDULA FRESH SUN GE L octinoxate, octisalate GEL TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; OCTISALATE 3.42; 1.71 g/57mL; g/57mL N 20181231 51346-451_718caeb8-3cb1-4636-8990-9c5440d101b8 51346-451 HUMAN OTC DRUG PROVENCE CALENDULA DAILY SUN BLOCK SPF50 Plus Octinoxate, Titanium dioxide, Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 4.27; 3.39; 1.42; 1.14; 1.14 g/57mL; g/57mL; g/57mL; g/57mL; g/57mL N 20181231 51346-452_3eed3307-a764-4916-a9c1-54b20230c269 51346-452 HUMAN OTC DRUG Aqua Collagen Solu tion Coenzyme Q10 Hydroge l Mask ADENOSINE PATCH TOPICAL 20150201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. ADENOSINE .008 g/20g N 20181231 51346-453_297b6015-9760-488e-ac76-3aad03085162 51346-453 HUMAN OTC DRUG Aqua Collagen Solu tion Multi Vitamin Hydroge l Mask NIACINAMIDE PATCH TOPICAL 20150201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE .4 g/20g N 20181231 51346-454_c9f4aa8e-09ac-40e7-94d8-ce3c04a1d6fe 51346-454 HUMAN OTC DRUG ARGAN ESSENTIAL DEEP CARE 300ML ARGAN SHAMPOO TOPICAL 20150901 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. ARGAN OIL .003 g/300mL N 20181231 51346-455_5d09588b-e5b7-476e-9045-d33da1abc7f5 51346-455 HUMAN OTC DRUG PURE BB CRE AM 21 LIGHT BEIGE Titanium dioxide, Octinoxate, Octisalate, Zinc oxide CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 1.14; .9; .3; .28 g/15mL; g/15mL; g/15mL; g/15mL N 20181231 51346-456_53a90b7c-9fc8-4622-bfcc-fb6b41721970 51346-456 HUMAN OTC DRUG PURE BB CRE AM 23 NATURAL BEIGE Titanium dioxide, Octinoxate, Octisalate, Zinc oxide CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 1.14; .9; .3; .28 g/15mL; g/15mL; g/15mL; g/15mL N 20181231 51346-457_2e30c5ca-87e9-47f6-a08e-7f6967053c46 51346-457 HUMAN OTC DRUG PURE COLOR CRE AM 01 BRIGHT PINK OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .9; .8 g/15mL; g/15mL N 20181231 51346-458_ff8addba-fbc7-4b14-bce3-672376b1166c 51346-458 HUMAN OTC DRUG PURE COLOR CRE AM 02 NATURAL BEIGE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .9; .8 g/15mL; g/15mL N 20181231 51346-459_c1f52095-c4e5-4531-81d0-e56ccb98b9e7 51346-459 HUMAN OTC DRUG SNAIL SOLU TION BB 02 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.16; 1.2; .76 g/40mL; g/40mL; g/40mL N 20181231 51346-460_9746cb74-7c8c-4457-b745-2c546ca33698 51346-460 HUMAN OTC DRUG PURE SHINE VANILLA MAKEUP BASE 01 VANILLA GREEN Titanium Dioxide, Octinoxate CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 1.76; .7 g/35g; g/35g N 20181231 51346-461_e5b2adbe-dd88-4413-af40-b29074a7bd98 51346-461 HUMAN OTC DRUG PURE SHINE VANILLA MAKEUP BASE 02 VANILLA PINK Titanium Dioxide, Octinoxate CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 1.76; .7 g/35g; g/35g N 20181231 51346-462_5477ec37-2b93-49d8-bf74-5ec8c0776246 51346-462 HUMAN OTC DRUG PURE FOUNDATION 23 NATURAL BEIGE SPF40 Titanium dioxide, Zinc oxide CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.63; .86 g/15mL; g/15mL N 20181231 51346-463_de097c5b-42d9-4884-8a54-6d8c5e78abcb 51346-463 HUMAN OTC DRUG PROVENCE INTENSIVE AMPOULE FOUNDATION 02 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.82; 1.2; .27 g/30mL; g/30mL; g/30mL N 20181231 51346-464_1fe976cf-e0f8-4e00-b046-5b3334a3c7b7 51346-464 HUMAN OTC DRUG PROVENCE INTENSIVE AMPOULE MAKE UP BASE 01 MINT Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 1.5; 1.47; 1.23 g/30mL; g/30mL; g/30mL N 20181231 51346-465_43fc88d8-b840-4f12-b4f6-f3643aeacd86 51346-465 HUMAN OTC DRUG PROVENCE AIR SKIN FIT OI L CONTROL BB CUSHION 01 LIGHT BEIGE ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE POWDER TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.24; 1.24; .91; .58 g/13g; g/13g; g/13g; g/13g N 20181231 51346-466_9c99c730-7579-476d-afc1-92d66b131240 51346-466 HUMAN OTC DRUG PROVENCE AIR SKIN FIT OI L CONTROL BB CUSHION 02 NATURAL BEIGE ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE POWDER TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.24; 1.24; .91; .58 g/13g; g/13g; g/13g; g/13g N 20181231 51346-467_783e2261-eefd-4666-8068-2ade78b19687 51346-467 HUMAN OTC DRUG PROVENCE INTENSIVE AMPOULE BB CUSHION 01 LIGHT BEIGE ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE POWDER TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.24; 1.24; .91; .58 g/13g; g/13g; g/13g; g/13g N 20181231 51346-468_5efa1986-74fc-4a96-8daf-1cf6d5b24655 51346-468 HUMAN OTC DRUG PROVENCE INTENSIVE AMPOULE BB CUSHION 02 NATURAL BEIGE ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE POWDER TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.24; 1.24; .91; .58 g/13g; g/13g; g/13g; g/13g N 20181231 51346-469_610930e6-0251-4e23-b268-cf00afe0ba70 51346-469 HUMAN OTC DRUG HERB BLENDING TONER Adenosine LIQUID TOPICAL 20170401 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. ADENOSINE .06 g/150mL N 20181231 51346-470_233ddd3b-5417-4bb7-9290-a019e12debc1 51346-470 HUMAN OTC DRUG HERB BLENDING Adenosine EMULSION TOPICAL 20170401 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. ADENOSINE .06 g/150mL N 20181231 51346-471_035f710a-68db-4bbe-bdff-b4e3f05250b5 51346-471 HUMAN OTC DRUG HERB BLENDING ESSENCE Adenosine LIQUID TOPICAL 20170401 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. ADENOSINE .02 g/50mL N 20181231 51346-472_902b1ed0-4a75-4ce4-802f-574ff77ddfec 51346-472 HUMAN OTC DRUG HERB BLENDING Adenosine CREAM TOPICAL 20170401 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. ADENOSINE .012 g/30mL N 20181231 51346-473_4ecddf00-23c0-447b-875f-c12b142859f6 51346-473 HUMAN OTC DRUG HERB BLENDING EYE Dimethicone CREAM TOPICAL 20170401 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE .6 g/30mL N 20181231 51346-474_fc1ca7eb-83d2-4360-b88d-2615f15d9521 51346-474 HUMAN OTC DRUG NATURE ORIGIN COVER TWO WAY PACT 01 LIGHT BEIGE Titanium Dioxide, Octinoxate, Zinc Oxide POWDER TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.04; .54; .26 g/9g; g/9g; g/9g N 20181231 51346-475_0d12c381-4c83-4f58-bedb-cdbf767980d0 51346-475 HUMAN OTC DRUG NATURE ORIGIN COVER TWO WAY PACT 02 NATURAL BEIGE Titanium Dioxide, Octinoxate, Zinc Oxide POWDER TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.04; .54; .26 g/9g; g/9g; g/9g N 20181231 51346-476_2e7b712f-e574-4133-8f63-240e1c3e233a 51346-476 HUMAN OTC DRUG PROVENCE INTENSE COVER 3 IN 1 STROBING FOUNDATION 01 LIGHT BEIGE A Titanium Dioxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE 2.38 g/10g N 20181231 51346-477_81b697ba-f743-40d0-9fe8-c4631b285e64 51346-477 HUMAN OTC DRUG PROVENCE INTENSE COVER 3 IN 1 STROBING FOUNDATION 01 LIGHT BEIGE B Titanium Dioxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE .07 g/g N 20181231 51346-478_12f8710b-33dc-4897-baf0-a72e1097415c 51346-478 HUMAN OTC DRUG PROVENCE INTENSE COVER 3 IN 1 STROBING FOUNDATION 01 LIGHT BEIGE C Titanium Dioxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE .21 g/g N 20181231 51346-479_8aabe5c5-fac9-427d-b0d6-856223fdd832 51346-479 HUMAN OTC DRUG PROVENCE INTENSE COVER 3 IN 1 STROBING FOUNDATION 02 NATURAL BEIGE A Titanium Dioxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE .07 g/g N 20181231 51346-480_844329e3-4d04-4ad1-a69f-95efd4b0ee0d 51346-480 HUMAN OTC DRUG PROVENCE INTENSE COVER 3 IN 1 STROBING FOUNDATION 02 NATURAL BEIGE B Titanium Dioxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE 2.38 g/10g N 20181231 51346-481_d12a1130-83e6-4d31-93c0-29c075bf55d2 51346-481 HUMAN OTC DRUG PROVENCE INTENSE COVER 3 IN 1 STROBING FOUNDATION 02 NATURAL BEIGE C Titanium Dioxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE .21 g/g N 20181231 51346-482_c959c949-1425-42a6-9476-cc16b64b4831 51346-482 HUMAN OTC DRUG PROVENCE AIR SKIN FIT BB CREA M 01 LIGHT BEIGE Titanium Dioxide, Octinoxate, Octisalate CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 2.14; 2.1; .9 g/30mL; g/30mL; g/30mL N 20181231 51346-483_166552c7-16f7-431e-9a78-22abb23a4d12 51346-483 HUMAN OTC DRUG PROVENCE AIR SKIN FIT BB CREA M 02 NATURAL BEIGE Titanium Dioxide, Octinoxate, Octisalate CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 2.14; 2.1; .9 g/30mL; g/30mL; g/30mL N 20181231 51346-484_b5a223d4-3005-4f8d-b05d-bdefda5d6792 51346-484 HUMAN OTC DRUG GINSENG ROYAL SILK POW DER 01 PURE BEIGE Titanium Dioxide, Octinoxate, Zinc Oxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.93; .54; .52 g/27g; g/27g; g/27g N 20181231 51346-485_3e69dc4b-57b5-4c90-941d-55cbc63edf06 51346-485 HUMAN OTC DRUG ICELAND FIRMING WATERY CREA M DIMETHICONE CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2.08 g/50mL N 20181231 51346-486_92a2e7ea-c0d2-4c16-83e1-0f2c8e64974c 51346-486 HUMAN OTC DRUG ICELAND BRIGHTENING WATERY CREA M DIMETHICONE CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2.99 g/50mL N 20181231 51346-487_2ef5160a-f069-43ac-8ef1-e097b67fee0b 51346-487 HUMAN OTC DRUG CALIFORNIA ALOE MILD SUN BLOCK OCTINOXATE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. OCTINOXATE; HOMOSALATE; OCTISALATE; TITANIUM DIOXIDE 3.87; 2.85; 2.56; .67 g/57mL; g/57mL; g/57mL; g/57mL N 20181231 51346-488_ee68efb8-f390-4b17-a214-e7c8982a6af4 51346-488 HUMAN OTC DRUG CALIFORNIA ALOE DAILY SUN BLOCK Homosalate, Octisalate, Titanium Dioxide, Avobenzone CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. HOMOSALATE; OCTISALATE; TITANIUM DIOXIDE; AVOBENZONE 5.7; 2.85; 2.45; 1.71 g/57mL; g/57mL; g/57mL; g/57mL N 20181231 51346-489_b95b9503-868f-4209-a3b8-28c86ae6201b 51346-489 HUMAN OTC DRUG NATURE ORIGIN COLLAGEN BB CRE AM 10 DARK BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.87; 1.35; .86 g/45g; g/45g; g/45g N 20181231 51346-490_54485f06-6bde-445c-9c17-234695a41f2e 51346-490 HUMAN OTC DRUG CALIFONIA ALOE ICE PUFF SUN CLEAR ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part352 NATURE REPUBLIC CO., LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; OCTOCRYLENE 6.58; 6; 4.15; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 51346-491_cc488f91-fff6-4ed4-a8bd-2631138dedf5 51346-491 HUMAN OTC DRUG BEE VENOM MIST ESSENCE bee venom SPRAY TOPICAL 20171001 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. APIS MELLIFERA VENOM .49 g/50mL N 20181231 51346-492_ed062bc8-320f-404d-a6a4-e13cdb73accb 51346-492 HUMAN OTC DRUG HERB BLENDING ESSENCE 100mL Adenosine LIQUID TOPICAL 20171201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. ADENOSINE .04 g/100mL N 20191231 51346-493_97a5f337-d9cb-4544-ad1c-ea38b15c9f4e 51346-493 HUMAN OTC DRUG CELL POWER ESSENTIAL SKIN Niacinamide, Adenosine LIQUID TOPICAL 20171201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE 2.4; .04 g/120mL; g/120mL N 20191231 51346-494_568f5bc6-c45f-40b6-9a27-bbe7220a24c3 51346-494 HUMAN OTC DRUG CELL POWER Niacinamide, Adenosine EMULSION TOPICAL 20171201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE 2.4; .04 g/120mL; g/120mL N 20191231 51346-495_48ee0832-d8b4-4d97-b900-9f3a32cc86e2 51346-495 HUMAN OTC DRUG CELL POWER ESSENCE Niacinamide, Adenosine LIQUID TOPICAL 20171201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE .8; .01 g/40mL; g/40mL N 20191231 51346-496_e609a11e-ded9-422f-b2ad-dcc2004af90f 51346-496 HUMAN OTC DRUG CELL POWER DAY Niacinamide, Adenosine CREAM TOPICAL 20171201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE 1.1; .02 g/55mL; g/55mL N 20191231 51346-497_9333dfae-f8ea-4c25-a694-cae9ccf5a8b6 51346-497 HUMAN OTC DRUG CELL POWER NIGHT Niacinamide, Adenosine CREAM TOPICAL 20171201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE 1.1; .02 g/55mL; g/55mL N 20191231 51346-498_6fb10adc-a826-463c-87ad-072e01a4ce07 51346-498 HUMAN OTC DRUG CELL POWER EYE Niacinamide, Adenosine CREAM TOPICAL 20171201 UNAPPROVED DRUG OTHER NATURE REPUBLIC CO., LTD. NIACINAMIDE; ADENOSINE .5; .01 g/25mL; g/25mL N 20191231 51346-499_666436d6-ca21-434a-832f-b04005701a88 51346-499 HUMAN OTC DRUG CELL POWER WATERY Dimethicone CREAM TOPICAL 20180102 OTC MONOGRAPH FINAL part347 NATURE REPUBLIC CO., LTD. DIMETHICONE 2.2 g/55mL N 20191231 51350-005_ded8ab1d-4ff4-422e-95e5-0582e06888e4 51350-005 HUMAN OTC DRUG Relovox Renewing Clarifying Cleanser EMULSION TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333D Transdermal Corp BENZOYL PEROXIDE 25 mg/g E 20171231 51350-011_2e03cdce-9668-41b3-9d88-95cfa038f581 51350-011 HUMAN OTC DRUG CURACAINE LIDOCAINE CREAM TOPICAL 20150303 OTC MONOGRAPH NOT FINAL part348 Transdermal Corp LIDOCAINE 4 g/100mL E 20171231 51350-012_9babc61c-e91f-44a9-a3cb-146e5c02aabe 51350-012 HUMAN OTC DRUG CURACAINE LIDOCAINE HCL CREAM TOPICAL 20120912 OTC MONOGRAPH NOT FINAL part348 Transdermal Corp LIDOCAINE HYDROCHLORIDE 4 g/100mL N 20181231 51350-111_fde0012f-0f00-4d01-b3fc-2eabb4061dea 51350-111 HUMAN OTC DRUG Cutiecaine Topical Lidocaine (5% w/w) CREAM TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part348 Transdermal Corp LIDOCAINE HYDROCHLORIDE 50 mg/g E 20171231 51352-010_bfb74540-00e1-4e7e-8f72-997322d342fe 51352-010 HUMAN OTC DRUG Pancold S Oral Acetaminophen, Guaifenesin LIQUID ORAL 20141101 OTC MONOGRAPH FINAL part341 Dong Wha Pharm. Co., Ltd. ACETAMINOPHEN; GUAIFENESIN 9000; 2499 mg/301; mg/301 E 20171231 51357-001_a618218f-7901-4603-b73d-bc6d459f94cb 51357-001 HUMAN OTC DRUG 2in1 Dandruff and Conditioner pyrithione zinc SHAMPOO TOPICAL 20120715 OTC MONOGRAPH FINAL part358H Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil PYRITHIONE ZINC 1 g/100mL E 20171231 51362-1677_359ef24d-379e-48ca-982c-40cdad5ee1aa 51362-1677 HUMAN OTC DRUG Blockout Foot Wipes Alcohol CLOTH TOPICAL 20100815 OTC MONOGRAPH FINAL part358 Ideas Born to Succeed ALCOHOL 1 ug/mL E 20171231 51362-6788_359ef24d-379e-48ca-982c-40cdad5ee1aa 51362-6788 HUMAN OTC DRUG Blockout Foot Wipes Alcohol CLOTH TOPICAL 20100920 OTC MONOGRAPH FINAL part358 Ideas Born to Succeed ALCOHOL 1 ug/mL E 20171231 51367-001_15de8ff9-5d90-4722-91c1-bb6c42b11582 51367-001 HUMAN OTC DRUG Yat Tip Xiao Salicylic Acid PLASTER TOPICAL 19770101 OTC MONOGRAPH FINAL part358F Internationa Nature Nutraceuticals, Inc SALICYLIC ACID 156 mg/1 N 20181231 51367-002_b585ed68-598a-4953-a527-fb63ae7d1dfe 51367-002 HUMAN OTC DRUG Cold Remedy Soothing Chlorpheniramine Maleate, Acetaminophen TABLET ORAL 19870224 OTC MONOGRAPH FINAL part341 International Nature Nutraceuticals CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN 1.05; 105 mg/1; mg/1 E 20171231 51367-003_10e18bd4-597f-471e-87bb-66bf88d3e9d0 51367-003 HUMAN OTC DRUG Shao Lin Gao Pain Relieving Plaster Camphor, Menthol, Methyl Salicylate PLASTER TOPICAL 19811102 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 21.21; 14.14; 64.45 mg/1; mg/1; mg/1 E 20171231 51367-004_dd369060-c05b-43c0-85a9-d9ea923937a5 51367-004 HUMAN OTC DRUG Yao Shen Gao Pain Relieving Plaster Camphor, Menthol, Methyl Salicylate PLASTER TOPICAL 19850629 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 43.76; 37.02; 72.39 mg/1; mg/1; mg/1 E 20171231 51367-005_d0a8f2c8-a3d5-4cac-b9bf-c4d8df7e2485 51367-005 HUMAN OTC DRUG Cold Remedy Gan Mao Ling Caffeine, Chlorpheniramine Maleate, Acetaminophen TABLET ORAL 20030728 OTC MONOGRAPH FINAL part341 International Nature Nutraceuticals CAFFEINE; CHLORPHENIRAMINE MALEATE; ACETAMINOPHEN 1; 1; 50 mg/1; mg/1; mg/1 E 20171231 51367-006_d973c827-3855-4b59-a199-a3fa34cf3ac6 51367-006 HUMAN OTC DRUG Fengliaoxing Fengshi Dieda Yaojiu Alcohol LIQUID TOPICAL 20010615 OTC MONOGRAPH NOT FINAL part333E International Nature Nutraceuticals ALCOHOL 128.21 g/1 E 20171231 51367-007_82c3a193-0d47-4406-b322-1bf831061da7 51367-007 HUMAN OTC DRUG Yu Long You Pain Relieving Camphor, Menthol, Methyl Salicylate LOTION TOPICAL 20030701 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3.97; 1.78; 7.04 g/1; g/1; g/1 E 20171231 51367-008_c6a87c56-6581-44f8-8f7a-9ae904fc871d 51367-008 HUMAN OTC DRUG Pi Yen Chin Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19850701 OTC MONOGRAPH FINAL part349 International Nature Nutraceuticals NAPHAZOLINE HYDROCHLORIDE 1 mg/1 N 20181231 51367-009_59910d36-ebbf-4a68-9fd1-ad6d724f408e 51367-009 HUMAN OTC DRUG Glycerin Liquid Laxative Enema(Kaisalilu) Glycerin LIQUID RECTAL 19920705 OTC MONOGRAPH NOT FINAL part334 International Nature Nutraceuticals GLYCERIN 12.5 g/1 E 20171231 51367-010_8de66e3b-0772-418f-9723-e0933282bf96 51367-010 HUMAN OTC DRUG Pain Relieving Balm Menthol, Camphor, Methyl Salicylate LINIMENT TOPICAL 20050501 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals, Inc. MENTHOL; CAMPHOR (NATURAL); METHYL SALICYLATE 6.19; 5.78; 15.66 g/1; g/1; g/1 E 20171231 51367-011_4d7fd70f-0ef6-48cb-b6ab-b9b9d316022f 51367-011 HUMAN OTC DRUG Strain Pain Relieving Cream Menthol, Camphor, Methyl Salicylate CREAM TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals MENTHOL; CAMPHOR (NATURAL); METHYL SALICYLATE 854.4; 796.8; 1.13 mg/1; mg/1; g/1 E 20171231 51367-014_566ddf02-c8df-4217-aa60-767010a8e2be 51367-014 HUMAN OTC DRUG Back Pain Relieving Oil Camphor, Methyl Salicylate, Menthol OIL TOPICAL 19660901 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); METHYL SALICYLATE; MENTHOL 3.49; 7.98; 3.92 g/1; g/1; g/1 E 20171231 51367-015_2263420f-076c-439a-a449-33c633d28a52 51367-015 HUMAN OTC DRUG Red Flower Oil Camphor, Methyl Salicylate OIL TOPICAL 19950601 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); METHYL SALICYLATE 2.09; 5.28 g/1; g/1 E 20171231 51367-016_15f75fe7-d049-4de6-80ac-6214bd5640a8 51367-016 HUMAN OTC DRUG Pain Relieving Po Tong Oil Camphor, Methyl Salicylate, Menthol OIL TOPICAL 19960601 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); METHYL SALICYLATE; MENTHOL 4.64; 14.65; 2.78 g/1; g/1; g/1 E 20171231 51367-017_656b1873-0b92-44b9-90ec-d1f9bf54c3b2 51367-017 HUMAN OTC DRUG Pain Relieving Chi Len Oil Camphor, Methyl Salicylate, Menthol OIL TOPICAL 19950601 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); METHYL SALICYLATE; MENTHOL 4.78; 14.65; 2.23 g/1; g/1; g/1 E 20171231 51367-018_57e9065a-22ec-4e10-bd5a-c431f5aa815e 51367-018 HUMAN OTC DRUG Pain Reileving Herbal Oil Camphor, Methyl Salicylate, Menthol OIL TOPICAL 19950601 OTC MONOGRAPH NOT FINAL part348 International Nature Nutracetucals CAMPHOR (NATURAL); METHYL SALICYLATE; MENTHOL 2.99; 9.16; 1.74 1/1; 1/1; 1/1 E 20171231 51367-019_65c1715d-d205-4b3e-81f8-9d40db26cb72 51367-019 HUMAN OTC DRUG Zhuanggu Shexiang Zhitonggao Pain Relieving Plaster Camphor, Menthol, Methyl Salicylate PLASTER TOPICAL 19910801 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 114.29; 114.29; 85.72 mg/1; mg/1; 1/1 E 20171231 51367-020_e6363226-3b02-4c5b-85cd-26076facd17b 51367-020 HUMAN OTC DRUG Refined Gou Pi Pain Relieving Plaster Methyl Salicylate, Camphor, Menthol PLASTER TOPICAL 19790516 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals METHYL SALICYLATE; CAMPHOR (NATURAL); MENTHOL 120.8; 116; 116 mg/1; mg/1; mg/1 N 20181231 51367-021_bcb09435-e0c8-460a-bb68-3fde762a0966 51367-021 HUMAN OTC DRUG Shang Shi Zhi Tong Pain Relieving Plaster Methyl Salicylate, Camphor, Menthol PLASTER TOPICAL 19760816 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals METHYL SALICYLATE; CAMPHOR (NATURAL); MENTHOL 120.8; 116; 116 mg/1; mg/1; mg/1 N 20181231 51367-022_6c46aa16-7dfc-43c9-a1e1-ac124e68287e 51367-022 HUMAN OTC DRUG Zhuang Gu Feng Shi Pain Relieving Plaster Methyl Salicylate, Camphor, Menthol PLASTER TOPICAL 19770716 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals METHYL SALICYLATE; CAMPHOR (NATURAL); MENTHOL 118.8; 116; 116 mg/1; mg/1; mg/1 N 20181231 51367-023_c07e57d4-b7c0-4dda-98d1-9c295154028b 51367-023 HUMAN OTC DRUG Shuang Long Pain Relieving Oil Menthol, Methyl Salicylate OIL TOPICAL 19900610 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals, Inc. MENTHOL; METHYL SALICYLATE 4.3; 9.4 g/1; g/1 E 20171231 51367-031_5cefa0ef-01d2-47e9-8be5-d6a267fe78dd 51367-031 HUMAN OTC DRUG Wok Lok Pain Relieving Oil Camphor, Menthol, Methyl Salicylate OIL TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals Inc. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 1.2; 5.6; 18.32 mg/1; mg/1; mg/1 N 20181231 51367-032_d99da891-dba1-4707-98a6-9ff855655e8f 51367-032 HUMAN OTC DRUG Medicated Balm Arthritis Pain Relieving Cream Camphor, Menthol CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part348 International Nature Nutraceuticals Inc. CAMPHOR (NATURAL); MENTHOL 6.75; 12 g/1; g/1 N 20181231 51384-100_fd01c72e-b0f1-4fc7-82c6-631459c95556 51384-100 HUMAN OTC DRUG AMMENS MEDICATED ZINC OXIDE POWDER TOPICAL 20100729 OTC MONOGRAPH FINAL part347 Botanicals Internacional S.A. de C.V. ZINC OXIDE 9.1 g/100g E 20171231 51386-702_c51d2610-b2e7-44ef-a6a6-9c757f0e3299 51386-702 HUMAN OTC DRUG napoleon PERDIS ADVANCED MINERAL MAKEUP BROAD SPECTRUM SPF 15 Look 2 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51386-703_2ccfee4a-0a55-4149-b59f-3fc49de18856 51386-703 HUMAN OTC DRUG napoleon PERDIS ADVANCED MINERAL MAKEUP BROAD SPECTRUM SPF 15 Look 3 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51386-704_4b4720bf-3480-4af6-943e-ce079afe3234 51386-704 HUMAN OTC DRUG napoleon PERDIS ADVANCED MINERAL MAKEUP BROAD SPECTRUM SPF 15 Look 4 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51386-705_6802b293-81e1-4bd8-b14d-b165311a80ba 51386-705 HUMAN OTC DRUG napoleon PERDIS ADVANCED MINERAL MAKEUP BROAD SPECTRUM SPF 15 Look 5 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51386-706_6711a652-60c8-407f-96f1-bb16e36d050f 51386-706 HUMAN OTC DRUG napoleon PERDIS ADVANCED MINERAL MAKEUP BROAD SPECTRUM SPF 15 Look 1 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 51386-710_69806131-5377-4a23-aa41-e3cb0e136a4d 51386-710 HUMAN OTC DRUG napoleon PERDIS CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 Look 2B TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 45; 29.7 mg/mL; mg/mL N 20181231 51386-711_1fc49272-ffd3-436d-8bcc-7e7e0e24f9bb 51386-711 HUMAN OTC DRUG napoleon PERDIS CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 Look 1 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 45; 29.7 mg/mL; mg/mL N 20181231 51386-712_80a6dc37-dc85-4a8c-92ba-a1b6d93eef3d 51386-712 HUMAN OTC DRUG napoleon PERDIS CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 Look 2 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 45; 29.7 mg/mL; mg/mL N 20181231 51386-713_fdf84555-e301-4f25-90cb-aa6d027e62bc 51386-713 HUMAN OTC DRUG napoleon PERDIS CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 Look 3 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 45; 29.7 mg/mL; mg/mL N 20181231 51386-714_22bdabcf-e94a-4d15-b868-b8582b908a79 51386-714 HUMAN OTC DRUG napoleon PERDIS CHINA DOLL FOUNDATION BROAD SPECTRUM SPF 15 Look 4 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc TITANIUM DIOXIDE; ZINC OXIDE 45; 29.7 mg/mL; mg/mL N 20181231 51386-721_c00f06ac-2d66-45a6-ab68-972c355e3ac0 51386-721 HUMAN OTC DRUG napoleon PERDIS SHEER GENIUS LIQUID FOUNDATION BROAD SPECTRUM SPF 20 Look 1 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 20; 35 mg/mL; mg/mL E 20171231 51386-722_d43ca171-7a32-4311-921e-15aa298b8fcc 51386-722 HUMAN OTC DRUG napoleon PERDIS SHEER GENIUS LIQUID FOUNDATION BROAD SPECTRUM SPF 20 Look 2 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 20; 35 mg/mL; mg/mL E 20171231 51386-723_50fd0b71-5b5f-4dcb-937b-0c84205efaef 51386-723 HUMAN OTC DRUG napoleon PERDIS SHEER GENIUS LIQUID FOUNDATION BROAD SPECTRUM SPF 20 Look 3 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 20; 35 mg/mL; mg/mL E 20171231 51386-724_61237d66-5af3-4abb-8ac2-2564819d6cdd 51386-724 HUMAN OTC DRUG napoleon PERDIS SHEER GENIUS LIQUID FOUNDATION BROAD SPECTRUM SPF 20 Look 4 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 20; 35 mg/mL; mg/mL E 20171231 51386-725_f68a1dc1-6416-4abb-9d24-5374a29a1f04 51386-725 HUMAN OTC DRUG napoleon PERDIS SHEER GENIUS LIQUID FOUNDATION BROAD SPECTRUM SPF 20 Look 5 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 20; 35 mg/mL; mg/mL E 20171231 51386-726_17fe7ec6-4b38-446d-8766-323009f6b6c4 51386-726 HUMAN OTC DRUG napoleon PERDIS SHEER GENIUS LIQUID FOUNDATION BROAD SPECTRUM SPF 20 Look 6 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 20; 35 mg/mL; mg/mL E 20171231 51386-731_4c3f7a16-13d7-405a-8b57-22e3ebe014a4 51386-731 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 1 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g N 20181231 51386-732_5b7ec36d-3b7b-4017-8032-9f34d7ef6c03 51386-732 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 2 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g N 20181231 51386-733_85278bed-4247-4060-9652-0bf63be590fa 51386-733 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 3 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g N 20181231 51386-734_d64a0d69-c19d-459c-8169-1e12ef6cf3dc 51386-734 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 4 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g N 20181231 51386-735_1fc1a155-66df-45ca-a238-f4f9cd85fc1a 51386-735 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 2B OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g N 20181231 51386-736_5bcae033-418b-45d4-91b8-9264deef0f05 51386-736 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 3B OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g N 20181231 51386-737_8b0806e4-f0d3-421b-a147-a195ccbb8331 51386-737 HUMAN OTC DRUG napoleon PERDIS FOUNDATION STICK BROAD SPECTRUM SPF 15 Look 5B OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 50; 20 mg/g; mg/g; mg/g N 20181231 51386-740_c57f81cc-01be-4449-bb6f-08e8e77a6324 51386-740 HUMAN OTC DRUG napoleon PERDIS AUTO PILOT BBB CREAM BROAD SPECTRUM SPF 30 LIGHT-MEDIUM ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 61.4; 69 mg/mL; mg/mL; mg/mL E 20171231 51386-741_be11b7a3-de3e-47ae-94c3-219e06cd9a44 51386-741 HUMAN OTC DRUG napoleon PERDIS AUTO PILOT BBB CREAM BROAD SPECTRUM SPF 30 MEDIUM-DARK ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part352 Napoleon Perdis Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 61.4; 69 mg/mL; mg/mL; mg/mL E 20171231 51389-107_70ca128b-e454-4bc5-8688-49448f1a10e0 51389-107 HUMAN OTC DRUG Real Deal Foundation DEEP TITANIUM DIOXIDE STICK TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 3; 5 g/100g; g/100g; g/100g N 20181231 51389-108_1c0bf028-e240-4667-887b-7a7695196fe1 51389-108 HUMAN OTC DRUG Real Deal Foundation FAIR TITANIUM DIOXIDE STICK TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 3; 5 g/100g; g/100g; g/100g N 20181231 51389-109_edb95fc8-fad8-4982-abe6-e64912d26d78 51389-109 HUMAN OTC DRUG Real Deal Foundation LIGHT TITANIUM DIOXIDE STICK TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 3; 5 g/100g; g/100g; g/100g N 20181231 51389-110_07f9890d-1a3d-4d1b-918e-f562791983f9 51389-110 HUMAN OTC DRUG Real Deal Foundation MEDIUM TITANIUM DIOXIDE STICK TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 3; 5 g/100g; g/100g; g/100g N 20181231 51389-111_c29c43c4-85ca-4e18-8e80-eb0bc7cd20cd 51389-111 HUMAN OTC DRUG Real Deal Foundation MEDIUM DEEP TITANIUM DIOXIDE STICK TOPICAL 20111113 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 3; 5 g/100g; g/100g; g/100g N 20181231 51389-113_b0f2a90e-77da-4c7c-8db1-87d908b4d4dc 51389-113 HUMAN OTC DRUG take cover anti-aging foundation FAIR OCTINOXATE CREAM TOPICAL 20120608 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.5; 1.95 g/100g; g/100g; g/100g E 20171231 51389-114_fb53a4d6-7a60-44b9-a661-d2fcd57d41ab 51389-114 HUMAN OTC DRUG take cover anti-aging foundation LIGHT OCTINOXATE CREAM TOPICAL 20120608 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.5; 1.95 g/100g; g/100g; g/100g E 20171231 51389-115_5499c7cb-1144-436d-9099-d34b6e37928a 51389-115 HUMAN OTC DRUG take cover anti-aging foundation MEDIUM OCTINOXATE CREAM TOPICAL 20120608 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.5; 1.95 g/100g; g/100g; g/100g E 20171231 51389-116_f2d935e6-ffb2-4457-acec-5db19e34289c 51389-116 HUMAN OTC DRUG take cover anti-aging foundation MEDIUM RICH OCTINOXATE CREAM TOPICAL 20120608 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.5; 1.95 g/100g; g/100g; g/100g E 20171231 51389-117_3054dbb2-c8c5-480a-aee3-cbde6081c523 51389-117 HUMAN OTC DRUG take cover anti-aging foundation MEDIUM DEEP OCTINOXATE CREAM TOPICAL 20120608 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.5; 1.95 g/100g; g/100g; g/100g E 20171231 51389-118_dd00f7d5-3cf1-4f45-b413-100c304d6143 51389-118 HUMAN OTC DRUG take cover anti-aging foundation DEEP OCTINOXATE CREAM TOPICAL 20120614 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.5; 1.95 g/100g; g/100g; g/100g E 20171231 51389-119_c7117dc3-2c86-4b23-8a89-a4b91e59ecd8 51389-119 HUMAN OTC DRUG color correcting swirl foundation broad spectrum SPF 25 LIGHT OCTOCRYLENE AVOBENZONE OCTISALATE CREAM TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTOCRYLENE; AVOBENZONE; OCTISALATE 5; 3; 3 g/100g; g/100g; g/100g E 20171231 51389-120_f601318f-24db-4b16-a140-4a2e933d19bf 51389-120 HUMAN OTC DRUG color correcting swirl foundation broad spectrum SPF 25 MEDIUM OCTOCRYLENE AVOBENZONE OCTISALATE CREAM TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTOCRYLENE; AVOBENZONE; OCTISALATE 5; 3; 3 g/100g; g/100g; g/100g E 20171231 51389-121_607cf3ce-1d5c-41c8-8d73-7b66b6c433c3 51389-121 HUMAN OTC DRUG color correcting swirl foundation broad spectrum SPF 25 TAN OCTOCRYLENE AVOBENZONE OCTISALATE CREAM TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. OCTOCRYLENE; AVOBENZONE; OCTISALATE 5; 3; 3 g/100g; g/100g; g/100g E 20171231 51389-122_bdbe3d7c-ae26-48c2-a439-5a36b204c3fb 51389-122 HUMAN OTC DRUG LAURA GELLER BEAUTY SUN KISSED COLOR LIP BALM TRIO BROAD SPECTRUM SPF 15 Pink - Coral - Berry OCTISALATE, AVOBENZONE, OCTINOXATE, OCTOCRYLENE KIT 20131209 OTC MONOGRAPH NOT FINAL part352 LAURA GELLER MAKE UP INC. N 20181231 51389-200_83a65b89-3ec7-4349-aca8-63ad595e026e 51389-200 HUMAN OTC DRUG LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER PORCELAIN AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 51389-201_d7d456f1-5e1e-4619-84a5-7b001e7413da 51389-201 HUMAN OTC DRUG LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER FAIR AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 51389-202_7b64863e-d932-482a-8379-2bd94644bac1 51389-202 HUMAN OTC DRUG LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 51389-203_b16c9f16-dea4-4310-8664-f204987f9fc4 51389-203 HUMAN OTC DRUG LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER TAN AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 51389-204_891d1a24-23b1-4e3d-a040-f398e1ca652e 51389-204 HUMAN OTC DRUG LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER DEEP AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 51389-210_4c12ba8c-6b31-4141-9232-e89fc4c620b6 51389-210 HUMAN OTC DRUG LAURA GELLER spackle Broad Spectrum SPF 30 protective under make-up primer AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 51389-250_6f7ab312-f3dd-47c6-aca0-d358b4321385 51389-250 HUMAN OTC DRUG skin elements liquid veil foundation broad spectrum SPF 25 PORCELAIN OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 40; 27 mg/mL; mg/mL; mg/mL E 20171231 51389-251_c3964561-2c02-41b9-9129-61ccf0e77f6b 51389-251 HUMAN OTC DRUG skin elements liquid veil foundation broad spectrum SPF 25 LIGHT OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 40; 27 mg/mL; mg/mL; mg/mL E 20171231 51389-252_5d93ca40-8374-46c6-a9dc-eb4015bf4aab 51389-252 HUMAN OTC DRUG skin elements liquid veil foundation broad spectrum SPF 25 MEDIUM OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 40; 27 mg/mL; mg/mL; mg/mL E 20171231 51389-253_30789218-1e08-469f-be94-61e9f83f196e 51389-253 HUMAN OTC DRUG skin elements liquid veil foundation broad spectrum SPF 25 GOLDEN MEDIUM OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 40; 27 mg/mL; mg/mL; mg/mL E 20171231 51389-254_66eddd8a-7072-4a59-aa7a-8f30dbcdd173 51389-254 HUMAN OTC DRUG skin elements liquid veil foundation broad spectrum SPF 25 TAN OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 40; 27 mg/mL; mg/mL; mg/mL E 20171231 51389-255_b79f2f73-7f87-47af-b45f-d7f7c9a54f60 51389-255 HUMAN OTC DRUG skin elements liquid veil foundation broad spectrum SPF 25 DEEP OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20140321 OTC MONOGRAPH NOT FINAL part352 Laura Geller Beauty, LLC OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 40; 27 mg/mL; mg/mL; mg/mL E 20171231 51393-4001_bed5c421-dc48-4e6d-bb7a-aeca3b588f33 51393-4001 HUMAN OTC DRUG Age Spot Control Thuja occidentalis leafy twig SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X]/100mL N 20181231 51393-4004_897e577e-49f5-463a-88ce-1b9b1cc5c2a8 51393-4004 HUMAN OTC DRUG Dark Circle Arnica Montana, Milk Thistle, and Berberis Vulgaris Fruit SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature ARNICA MONTANA; MILK THISTLE; BERBERIS VULGARIS FRUIT 12; 10; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL N 20181231 51393-4006_2dd07322-c50a-48f0-b56a-c7a340e037da 51393-4006 HUMAN OTC DRUG ROSACEA THUJA OCCIDENTALIS LEAFY TWIG SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature THUJA OCCIDENTALIS LEAFY TWIG 8 [hp_X]/1000mL N 20181231 51393-4007_e6905a99-f236-4c50-b14b-7c6759789862 51393-4007 HUMAN OTC DRUG Scabies Control THUJA OCCIDENTALIS LEAF SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature THUJA OCCIDENTALIS LEAF 12 [hp_X]/100mL N 20181231 51393-4008_48f0d7a5-575f-4fa5-8358-6ce511ae61b5 51393-4008 HUMAN OTC DRUG Scalp Dermatitis URTICA DIOICA SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature URTICA DIOICA 6 [hp_C]/1000mL N 20181231 51393-4009_65a11119-0e66-49ce-8ccb-011f32f53191 51393-4009 HUMAN OTC DRUG Muscle Pain Pain Management Arnica Montana, Horse Chestnut, Hypericum Perforatum, Ruta Graveolens Flowering Top, and Thuja Occidentalis Leafy Twig SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature ARNICA MONTANA; HORSE CHESTNUT; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 30; 6; 12; 30; 6 [hp_C]/1000mL; [hp_C]/1000mL; [hp_C]/1000mL; [hp_C]/1000mL; [hp_X]/1000mL N 20181231 51393-4010_3e580f1d-f7ef-4fff-8973-cf4c8b1d3b54 51393-4010 HUMAN OTC DRUG Stretch Mark Control Calendula Officinalis Flower, Hydrated Silica, and Allylthiourea SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWER; HYDRATED SILICA; ALLYLTHIOUREA 6; 6; 8 [hp_X]/100mL; [hp_X]/100mL; [hp_C]/100mL N 20181231 51393-4012_089852c9-4482-45d0-a85d-d4fa7d0a79fe 51393-4012 HUMAN OTC DRUG Wrinkle Control THUJA OCCIDENTALIS LEAF SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature THUJA OCCIDENTALIS LEAF 6 [hp_X]/100mL N 20181231 51393-4013_d647f116-dfde-4766-bc59-fa1df8a4d824 51393-4013 HUMAN OTC DRUG Skin Tags Thuja Occidentalis Leafy Twig and Calendula Officinalis Whole SOLUTION/ DROPS TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Forces of Nature THUJA OCCIDENTALIS LEAFY TWIG; CALENDULA OFFICINALIS WHOLE 6; 6 [hp_X]/100mL; [hp_X]/100mL N 20181231 51393-5622_9390e81a-6e4b-49d7-bacb-503c4d5d926f 51393-5622 HUMAN OTC DRUG Eczema Control Centella Asiatica, Iris Versicolor Root, Arctium Lappa Root, Sodium Chloride, Ruta Graveolens Flowering Top, Silicon Dioxide, Taraxacum Officinale, and Thuja Occidentalis Root SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature CENTELLA ASIATICA; IRIS VERSICOLOR ROOT; ARCTIUM LAPPA ROOT; SODIUM CHLORIDE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS ROOT 12; 12; 12; 12; 12; 6; 6; 8 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_X]/100mL; [hp_C]/100mL; [hp_X]/100mL; [hp_C]/100mL; [hp_X]/100mL N 20181231 51393-6111_2f488ebc-148b-4f8e-a8aa-d687b29ae91c 51393-6111 HUMAN OTC DRUG Acne Care CALENDULA OFFICINALIS FLOWERING TOP, GERANIUM MACULATUM ROOT, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; SILICON DIOXIDE 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6112_69d9d95b-d63a-4ced-80c0-974d57b932c7 51393-6112 HUMAN OTC DRUG Acne/Pimple Control CALENDULA OFFICINALIS FLOWERING TOP and SILICON DIOXIDE SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 6; 6 [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-6113_cf32e409-fe6a-4162-b1b4-0407625a33dc 51393-6113 HUMAN OTC DRUG Acne/Pimple Cleanse Silicon Dioxide and Calendula Officinalis Flowering Top SOAP TOPICAL 20130915 UNAPPROVED HOMEOPATHIC Forces of Nature SILICON DIOXIDE; CALENDULA OFFICINALIS FLOWERING TOP 6; 6 [hp_X]/100g; [hp_X]/100g N 20181231 51393-6222_deb4d864-325a-4cfa-8830-ef36c54ff9ca 51393-6222 HUMAN OTC DRUG Eczema Control Chamomile, Graphite, and Hypericum Perforatum SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CHAMOMILE; GRAPHITE; HYPERICUM PERFORATUM 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6333_107f54f8-86f3-4dcb-a3b4-72cbcb689941 51393-6333 HUMAN OTC DRUG Fissure Control Aloe, CALENDULA OFFICINALIS FLOWERING TOP, Hamamelis virginiana Root Bark/Stem Bark, and Lycopodium clavatum Spore SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature ALOE; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LYCOPODIUM CLAVATUM SPORE 6; 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6334_c2ab1909-17f5-462b-a933-f339aa4527f1 51393-6334 HUMAN OTC DRUG Fissure Control Calendula Officinalis Flowering Top And Hamamelis Virginiana Root Bark/Stem Bark SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6; 6 [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-6444_5d9c71ea-a88f-480f-936e-aeb2640f5d96 51393-6444 HUMAN OTC DRUG Hemorrhoid Control Aloe, CALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, and Lycopodium clavatum Spore SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature ALOE; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LYCOPODIUM CLAVATUM SPORE 6; 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6445_9a533ffb-dbef-4c14-ad96-9cbfefa24a74 51393-6445 HUMAN OTC DRUG Hemorrhoid Control Extra Strength Aloe, CALENDULA OFFICINALIS FLOWERING TOP, Hamamelis virginiana Root Bark/Stem Bark, Lycopodium clavatum Spore, Chamomile, and Geranium Maculatum Root SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature ALOE; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LYCOPODIUM CLAVATUM SPORE; CHAMOMILE; GERANIUM MACULATUM ROOT 8; 8; 8; 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6446_b8d485ed-0c34-473f-a5c6-99939f4504ef 51393-6446 HUMAN OTC DRUG Hemorrhoid Control HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and HORSE CHESTNUT SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT 6; 6 [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-6447_dcc1171a-2ced-409d-8df2-b5df077fff58 51393-6447 HUMAN OTC DRUG Hemorrhoid Control Extra Strength Hamamelis Virginiana Root Bark/Stem Bark and Horse Chestnut SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT 8; 8 [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-6543_35827bd2-0e3b-4a97-82b3-c0d1b3d8bf91 51393-6543 HUMAN OTC DRUG Eczema Cleanse Iris Versicolor Root, Arctium Lappa Root, Ruta Graveolens Flowering Top, Centella Asiatica, Sodium Chloride, Silicon Dioxide, Taraxacum Officinale, and Thuja Occidentalis Leafy Twig SOAP TOPICAL 20130915 UNAPPROVED HOMEOPATHIC Forces of Nature IRIS VERSICOLOR ROOT; ARCTIUM LAPPA ROOT; RUTA GRAVEOLENS FLOWERING TOP; CENTELLA ASIATICA; SODIUM CHLORIDE; SILICON DIOXIDE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 6; 6; 8 [hp_C]/100g; [hp_C]/100g; [hp_C]/100g; [hp_C]/100g; [hp_C]/100g; [hp_X]/100g; [hp_C]/100g; [hp_X]/100g N 20181231 51393-6555_97b303dd-51ba-42ee-a807-aa963bf0f1b8 51393-6555 HUMAN OTC DRUG H-Balm Daily CALENDULA OFFICINALIS FLOWERING TOP, Geranium Maculatum Root, SODIUM CHLORIDE, and THUJA OCCIDENTALIS LEAFY TWIG SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6557_8423b3ff-0ecc-4bdf-99b8-7904990e27f6 51393-6557 HUMAN OTC DRUG H-Balm Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, Geranium Maculatum Root, SODIUM CHLORIDE, THUJA OCCIDENTALIS LEAFY TWIG, Zinc, and Echinacea angustifolia SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; ZINC; ECHINACEA ANGUSTIFOLIA 10; 10; 10; 10; 10; 10 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6558_45cfab58-dc1b-46ff-a8c5-98bb4250c534 51393-6558 HUMAN OTC DRUG H-Balm Super Strength CALENDULA OFFICINALIS FLOWERING TOP, GERANIUM MACULATUM ROOT, SODIUM CHLORIDE, THUJA OCCIDENTALIS LEAFY TWIG, ZINC, and ECHINACEA ANGUSTIFOLIA SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; ZINC; ECHINACEA ANGUSTIFOLIA 12; 12; 12; 12; 12; 12 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6655_67f69c94-087f-4e09-a931-24910b3c3a8a 51393-6655 HUMAN OTC DRUG H-Balm Daily CALENDULA OFFICINALIS FLOWERING TOP and Thuja occidentalis leafy twig SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-6656_a9bff37d-3579-4ef6-9eb7-fbfe36adbb4f 51393-6656 HUMAN OTC DRUG H-Balm Control CALENDULA OFFICINALIS FLOWERING TOP, SODIUM CHLORIDE, and Thuja occidentalis leafy twig SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-6657_d4bd9d82-fdb6-41d6-9e8f-e6720fb63035 51393-6657 HUMAN OTC DRUG H-Balm Control Extra Strength calendula officinalis flowering top, echinacea, sodium chloride, and thuja occidentalis leafy twig SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-6658_4407cfc8-cbbe-4b5f-b6f1-3df6bf83083e 51393-6658 HUMAN OTC DRUG H-Balm Control Extreme Strength CALENDULA OFFICINALIS FLOWERING TOP, Echinacea angustifolia, SODIUM CHLORIDE, and Thuja occidentalis Leafy Twig SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-6659_9a03f0c4-927c-4c64-8f80-be0443ec90d4 51393-6659 HUMAN OTC DRUG H-Balm Cleanse Sodium Chloride, Thuja Occidentalis Bark, and Calendula Officinalis Flowering Top SOAP TOPICAL 20130915 UNAPPROVED HOMEOPATHIC Forces of Nature SODIUM CHLORIDE; THUJA OCCIDENTALIS BARK; CALENDULA OFFICINALIS FLOWERING TOP 8; 8; 8 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g N 20181231 51393-6666_1faec7c3-ec53-44f4-9843-e05e35694225 51393-6666 HUMAN OTC DRUG Nevi (Mole) Control CALENDULA OFFICINALIS FLOWERING TOP, PHYTOLACCA AMERICANA ROOT, SILICON DIOXIDE, and THUJA OCCIDENTALIS LEAFY TWIG SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6667_a808a3da-1b11-4ca8-96a1-dce16675e52e 51393-6667 HUMAN OTC DRUG Nevi (Mole) Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, PHYTOLACCA AMERICANA ROOT, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIG, and GERANIUM MACULATUM ROOT SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; GERANIUM MACULATUM ROOT 8; 8; 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6668_723d955c-495f-48e8-bc9b-fe9c52d23319 51393-6668 HUMAN OTC DRUG Nevi (Mole) Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, Phytolacca Americana Root, Silicon Dioxide, and Thuja occidentalis Leafy Twig SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 8; 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6669_5391015d-a252-4f1c-b465-031188a0db64 51393-6669 HUMAN OTC DRUG Wart Cleanse THUJA OCCIDENTALIS BARK, PHYTOLACCA AMERICANA ROOT, and CALENDULA OFFICINALIS FLOWERING TOP SOAP TOPICAL 20130915 UNAPPROVED HOMEOPATHIC Forces of Nature THUJA OCCIDENTALIS BARK; PHYTOLACCA AMERICANA ROOT; CALENDULA OFFICINALIS FLOWERING TOP 6; 6; 6 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g N 20181231 51393-6777_453bd029-a59b-4c06-944e-fcf644bcac5d 51393-6777 HUMAN OTC DRUG Molluscum Control Lycopodium clavatum Spore, SODIUM CHLORIDE, and Thuja occidentalis leafy twig SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6778_3dd341b1-ae0c-4525-bed5-75713fa26392 51393-6778 HUMAN OTC DRUG Molluscum Control Thuja Occidentalis Leafy Twig and Sodium Chloride SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature THUJA OCCIDENTALIS LEAFY TWIG; SODIUM CHLORIDE 6; 6 [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6888_403fe2cc-75db-4bb2-9530-5cf19677fc29 51393-6888 HUMAN OTC DRUG Nail Fungus Control CALENDULA OFFICINALIS FLOWERING TOP and SILICON DIOXIDE SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 6; 6 [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6889_4439d487-0766-41b7-a2c7-5550b9e6209f 51393-6889 HUMAN OTC DRUG Nail Fungus Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, GERANIUM MACULATUM ROOT, HYPERICUM PERFORATUM, and SILICON DIOXIDE SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; HYPERICUM PERFORATUM; SILICON DIOXIDE 8; 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-6987_75316100-83ee-439b-bd49-71268fb341bc 51393-6987 HUMAN OTC DRUG FUNGAL CLEANSE CALENDULA OFFICINALIS FLOWERING TOP and SILICON DIOXIDE SOAP TOPICAL 20130915 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 6; 6 [hp_X]/100g; [hp_X]/100g N 20181231 51393-6988_3d80d1e8-b1bf-4c16-8848-71dbbd2f5df4 51393-6988 HUMAN OTC DRUG Nail Fungus Control Calendula Officinalis Flowering Top and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 6; 6 [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-6989_b68f11b6-d10c-48ea-aea3-a6cf258088f2 51393-6989 HUMAN OTC DRUG Nail Fungus Control Extra Strength Calendula Officinalis Flowering Top, Silicon Dioxide, and Hypericum Perforatum SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC  Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; HYPERICUM PERFORATUM 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-7111_165baf68-b46c-4ef3-a9ba-9b765c1ac211 51393-7111 HUMAN OTC DRUG Scar Control CALENDULA OFFICINALIS FLOWERING TOP, Graphite, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; SILICON DIOXIDE 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-7112_833883ef-d920-424e-a677-4aca11ae22ca 51393-7112 HUMAN OTC DRUG Scar Control Calendula Officinalis Flowering Top, Allylthiourea, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; ALLYLTHIOUREA; SILICON DIOXIDE 6; 8; 6 [hp_X]/1000mL; [hp_C]/1000mL; [hp_X]/1000mL N 20181231 51393-7222_9c0fe309-ff5a-47fa-8e56-343988465ce8 51393-7222 HUMAN OTC DRUG Shingles Control CALENDULA OFFICINALIS FLOWERING TOP, GERANIUM MACULATUM ROOT, SODIUM CHLORIDE, and RANUNCULUS BULBOSUS SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; SODIUM CHLORIDE; RANUNCULUS BULBOSUS 6; 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-7223_b1520ebe-ddb2-4986-b06c-6d53c0d963ad 51393-7223 HUMAN OTC DRUG Shingles Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, Geranium Maculatum Root, SODIUM CHLORIDE, Ranunculus bulbosus, Toxicodendron pubescens leaf, and Zinc SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; GERANIUM MACULATUM ROOT; SODIUM CHLORIDE; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; ZINC 8; 8; 8; 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-7322_fb5c5ea2-e1ff-489b-8e61-f6e8eb1dec5b 51393-7322 HUMAN OTC DRUG Shingles Control CALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM, and SODIUM CHLORIDE SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; SODIUM CHLORIDE 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-7323_675f6a97-2d8b-443b-ae99-fa314e16aaa4 51393-7323 HUMAN OTC DRUG Shingles Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM, and SODIUM CHLORIDE SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; SODIUM CHLORIDE 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-7333_bdd05197-e082-4f35-8751-fb5954466009 51393-7333 HUMAN OTC DRUG Wart Control CALENDULA OFFICINALIS FLOWERING TOP, Causticum, Phytolacca Americana Root, and Thuja occidentalis leafy twig SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-7334_fa42d2f8-833a-40cb-a5ee-793166f699ce 51393-7334 HUMAN OTC DRUG Wart Control Extra Strength CALENDULA OFFICINALIS FLOWERING TOP, Causticum, PHYTOLACCA AMERICANA ROOT, THUJA OCCIDENTALIS LEAFY TWIG, and SODIUM CHLORIDE SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG; SODIUM CHLORIDE 8; 8; 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-7335_3c8202a6-4806-47de-92cd-4b597a83d493 51393-7335 HUMAN OTC DRUG Wart Control Super Strength CALENDULA OFFICINALIS FLOWERING TOP, CAUSTICUM, PHYTOLACCA AMERICANA ROOT, THUJA OCCIDENTALIS LEAFY TWIG, SODIUM CHLORIDE, and SALICYLIC ACID SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG; SODIUM CHLORIDE; SALICYLIC ACID 10; 10; 10; 10; 10; 10 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-7336_549b4b9c-fc9e-4ddf-8a2f-4fcdad569ed2 51393-7336 HUMAN OTC DRUG Wart Control Extreme CALENDULA OFFICINALIS FLOWERING TOP, Causticum, Phytolacca Americana Root, Thuja occidentalis leafy twig, SODIUM CHLORIDE, and Salicylic Acid SOLUTION/ DROPS TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG; SODIUM CHLORIDE; SALICYLIC ACID 12; 12; 12; 12; 12; 12 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-7433_64f81768-7895-4130-bb10-325f06d1885c 51393-7433 HUMAN OTC DRUG Wart Control CALENDULA OFFICINALIS FLOWERING TOP, THUJA OCCIDENTALIS LEAFY TWIG, and PHYTOLACCA AMERICANA ROOT SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; PHYTOLACCA AMERICANA ROOT 6; 6; 6 [hp_M]/1000mL; [hp_M]/1000mL; [hp_M]/1000mL N 20181231 51393-7434_8ae0549f-64e0-403a-bf58-eda6abc4db27 51393-7434 HUMAN OTC DRUG Wart Control Extra Strength Calendula Officinalis Flowering Top, Phytolacca Americana Root, And Thuja Occidentalis Leafy Twig SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 8; 8; 8 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-7436_04554d3c-145a-4832-9eed-a40a18e98b92 51393-7436 HUMAN OTC DRUG Wart Control Extreme CALENDULA OFFICINALIS FLOWERING TOP, PHYTOLACCA AMERICANA ROOT, and THUJA OCCIDENTALIS LEAFY TWIG SOLUTION/ DROPS TOPICAL 20110406 UNAPPROVED HOMEOPATHIC Forces of Nature CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-7522_dc6563c3-3f18-4d5a-bf44-02304df92733 51393-7522 HUMAN OTC DRUG Rheumatoid Arthritis Pain Management Horse Chestnut, Caulophyllum Thalictroides Root, Phytolacca Americana Root, Ruta Graveolens Flowering Top, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20130101 UNAPPROVED HOMEOPATHIC Forces of Nature HORSE CHESTNUT; CAULOPHYLLUM THALICTROIDES ROOT; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE 12; 3; 12; 30; 12 [hp_C]/100mL; [hp_X]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_X]/100mL N 20181231 51393-7533_f961c452-78b0-40ee-b69d-f56ee92cc1f9 51393-7533 HUMAN OTC DRUG Sleep Well Being Control Avena Sativa Flowering Top, Arabica Coffee Bean, Lavandula Angustifolia Flowering Top, Passiflora Incarnata Flowering Top, Piper Methysticum Root, and Valerian SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; LAVANDULA ANGUSTIFOLIA FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PIPER METHYSTICUM ROOT; VALERIAN 30; 30; 12; 30; 30; 12 [hp_X]/1000mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL N 20181231 51393-7544_374c6a4b-4ed6-4da8-bddf-8236661b8206 51393-7544 HUMAN OTC DRUG Insomnia Control Arabica Coffee Bean, Lactuca Virosa, Lavandula Angustifolia Flowering Top, HOPS, Piper Methysticum Root, Verbena Hastata Root, and Scutellaria Lateriflora SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature ARABICA COFFEE BEAN; LACTUCA VIROSA; LAVANDULA ANGUSTIFOLIA FLOWERING TOP; HOPS; PIPER METHYSTICUM ROOT; VERBENA HASTATA ROOT; SCUTELLARIA LATERIFLORA 30; 12; 12; 30; 30; 6; 12 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL N 20181231 51393-7566_b0a086de-94d0-41e5-9d6e-a07cf945e786 51393-7566 HUMAN OTC DRUG Nerve Pain Arabica Coffee Bean, Silicon Dioxide, and Hypericum Perforatum SOLUTION/ DROPS TOPICAL 20130101 UNAPPROVED HOMEOPATHIC Forces of Nature ARABICA COFFEE BEAN; SILICON DIOXIDE; HYPERICUM PERFORATUM 30; 30; 30 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL N 20181231 51393-7577_a3b5de59-677a-4d8a-92c8-fe33c2916e11 51393-7577 HUMAN OTC DRUG Headache Pain Management Iris Versicolor Root, Lavandula Angustifolia Flowering Top, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature IRIS VERSICOLOR ROOT; LAVANDULA ANGUSTIFOLIA FLOWERING TOP; SILICON DIOXIDE 30; 12; 30 [hp_C]/1000mL; [hp_X]/1000mL; [hp_C]/1000mL N 20181231 51393-7588_3bbce80f-738e-4b0f-809f-b3fd07cc527a 51393-7588 HUMAN OTC DRUG Migraine Pain Management Iris Versicolor Root and Sodium Chloride SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature IRIS VERSICOLOR ROOT; SODIUM CHLORIDE 30; 30 [hp_X]/100mL; [hp_C]/100mL N 20181231 51393-7590_22a4b29d-a4df-4426-a3ce-ddb4c797aa2a 51393-7590 HUMAN OTC DRUG Osteoarthritis Pain management Horse Chestnut and Ruta Graveolens Flowering Top SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature HORSE CHESTNUT; RUTA GRAVEOLENS FLOWERING TOP 30; 30 [hp_C]/1000mL; [hp_C]/100mL N 20181231 51393-7591_794229a7-d95c-4285-92a8-f6385330b7f1 51393-7591 HUMAN OTC DRUG Joint Pain Pain Management Aesculus Hippocastanum Whole and Ruta Graveolens Whole SOLUTION/ DROPS TOPICAL 20170115 UNAPPROVED HOMEOPATHIC Forces of Nature AESCULUS HIPPOCASTANUM WHOLE; RUTA GRAVEOLENS WHOLE 30; 30 [hp_C]/1000mL; [hp_C]/1000mL N 20181231 51393-7599_d03c9804-011e-4eb7-9c6e-1038881c7894 51393-7599 HUMAN OTC DRUG Ringworm Control Thuja Occidentalis Leaf, Silicon Dioxide, and Sodium Chloride SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature THUJA OCCIDENTALIS LEAF; SILICON DIOXIDE; SODIUM CHLORIDE 10; 10; 10 [hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-7611_164236a6-17ce-40c8-ac4e-94424677b19a 51393-7611 HUMAN OTC DRUG Athletes Foot/Jock Itch Control Centella Asiatica, Silicon Dioxide, and Thuja Occidentalis Root SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature CENTELLA ASIATICA; SILICON DIOXIDE; THUJA OCCIDENTALIS ROOT 30; 8; 30 [hp_C]/1000mL; [hp_X]/1000mL; [hp_C]/1000mL N 20181231 51393-7633_1141e3e2-ad9c-44c2-81f6-6ed09220e1e8 51393-7633 HUMAN OTC DRUG Psoriasis Control Centella Asiatica, Sodium Chloride, and Silicon Dioxide SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature CENTELLA ASIATICA; SODIUM CHLORIDE; SILICON DIOXIDE 12; 30; 8 [hp_C]/100mL; [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51393-7655_79027444-53c9-4c61-96f1-c2a38e521565 51393-7655 HUMAN OTC DRUG Gout Control Arnica Montana, Urtica Urens, Silicon Dioxide, and Thuja Occidentalis Root SOLUTION/ DROPS TOPICAL 20111201 UNAPPROVED HOMEOPATHIC Forces of Nature ARNICA MONTANA; URTICA URENS; SILICON DIOXIDE; THUJA OCCIDENTALIS ROOT 30; 30; 8; 12 [hp_C]/100mL; [hp_C]/100mL; [hp_X]/1000mL; [hp_X]/1000mL E 20171231 51393-7656_63f71742-7dad-4ac1-aa75-e1b465d36310 51393-7656 HUMAN OTC DRUG Gout Pain Management Arnica Montana, Urtica Urens, Silicon Dioxide, and Thuja Occidentalis Leaf SOLUTION/ DROPS TOPICAL 20170215 UNAPPROVED HOMEOPATHIC Forces of Nature ARNICA MONTANA; URTICA URENS; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAF 30; 30; 8; 12 [hp_C]/1000mL; [hp_C]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL N 20181231 51395-412_0257f46d-60b6-4b34-8baa-77d8b3a42032 51395-412 HUMAN OTC DRUG Top Safety First Aid Burn Cream Lidocaine CREAM TOPICAL 20160207 OTC MONOGRAPH NOT FINAL part348 Top Safety Products Company Inc LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE .5; .13 g/100g; g/100g N 20181231 51400-001_02f43acd-95a8-42ba-bd12-cdfea66a36aa 51400-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19760101 UNAPPROVED MEDICAL GAS Mid South Welding Supply, Inc OXYGEN 99 L/100L N 20181231 51401-002_c536b73e-65b8-4dae-9e44-32124e551aab 51401-002 HUMAN OTC DRUG SKIN STRONG - SKIN EQUIPMENT SPF 55 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20120830 OTC MONOGRAPH FINAL part352 True Balance Athletics LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 51401-030_e3470bcf-caa8-443f-91d5-329acba12c76 51401-030 HUMAN OTC DRUG SKIN STRONG - SKIN EQUIPMENT SPF 30 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120830 OTC MONOGRAPH FINAL part352 True Balance Athletics LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 75; 50; 27.5; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 51414-100_620623fa-1405-93d0-e053-2a91aa0aaebb 51414-100 HUMAN OTC DRUG HAND SANITIZER ALCOHOL GEL TOPICAL 20100629 OTC MONOGRAPH NOT FINAL part333A Yuyao Jessie Promotional Products Co., Ltd. ALCOHOL 62 mL/100mL N 20191231 51414-101_6207ccff-c165-d345-e053-2991aa0a803b 51414-101 HUMAN OTC DRUG aloe vera gel ALOE VERA LEAF GEL TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part356 Yuyao Jessie Commodity Co.,Ltd. ALOE VERA LEAF 5 g/100g N 20191231 51414-103_6207329a-5208-cbcf-e053-2a91aa0a719d 51414-103 HUMAN OTC DRUG antibacterial hand sanitizer Benzalkonium Chloride SPRAY TOPICAL 20140227 OTC MONOGRAPH NOT FINAL part333E Yuyao Jessie Commodity Co.,Ltd. BENZALKONIUM CHLORIDE .4 g/100g N 20191231 51414-104_6207329a-51ee-cbcf-e053-2a91aa0a719d 51414-104 HUMAN OTC DRUG SPF30 sunscreen Octinoxate,oxybenzone,OCTISALATE SPRAY TOPICAL 20120912 OTC MONOGRAPH NOT FINAL part352 Yuyao Jessie Commodity Co.,Ltd. OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 4 g/100g; g/100g; g/100g N 20191231 51414-105_6207329a-51f7-cbcf-e053-2a91aa0a719d 51414-105 HUMAN OTC DRUG Mouthwash Cetylpyridinium chloride RINSE DENTAL 20160110 OTC MONOGRAPH NOT FINAL part356 Yuyao Jessie Commodity Co.,Ltd. CETYLPYRIDINIUM CHLORIDE .07 g/100g N 20191231 51414-106_62067592-a748-1cc4-e053-2a91aa0a6139 51414-106 HUMAN OTC DRUG Insect Bite Relief Hydrocortisone SPRAY TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 Yuyao Jessie Commodity Co.,Ltd. HYDROCORTISONE 1 g/100g N 20191231 51414-107_62067592-a6d9-1cc4-e053-2a91aa0a6139 51414-107 HUMAN OTC DRUG 1% Hydrocortisone Hydrocortisone CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part348 Yuyao Jessie Commodity Co.,Ltd. HYDROCORTISONE 1 g/100g N 20191231 51414-200_ead90432-b6f9-457d-a022-b0c76a2e9d24 51414-200 HUMAN OTC DRUG Sun Block octyl methoxycinnamate BENZOPHENONE-3 TITANIUM DIOXIDE Homosalate CREAM TOPICAL 20100630 OTC MONOGRAPH FINAL part352 Yuyao Jessie Promotional Products Co., Ltd. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; HOMOSALATE 8; 7.5; 8; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 51414-201_6259609f-862a-1472-e053-2991aa0a10a2 51414-201 HUMAN OTC DRUG Sun Block octyl methoxycinnamate BENZOPHENONE-3 TITANIUM DIOXIDE Homosalate CREAM TOPICAL 20100630 OTC MONOGRAPH FINAL part352 Yuyao Jessie Commodity Co.,Ltd. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; HOMOSALATE 8; 7.5; 8; 6 g/100g; g/100g; g/100g; g/100g N 20191231 51414-300_6207329a-5200-cbcf-e053-2a91aa0a719d 51414-300 HUMAN OTC DRUG LIP BALM Avobenzone Octinoxate OINTMENT TOPICAL 20100919 OTC MONOGRAPH FINAL part352 Yuyao Jessie Promotional Products Co., Ltd. AVOBENZONE; OCTINOXATE 1.5; 6 g/100g; g/100g N 20191231 51414-400_6208bcf5-63fd-b225-e053-2991aa0a5546 51414-400 HUMAN OTC DRUG antibacterial wet wipes Benzalkonium Chloride SWAB TOPICAL 20120508 OTC MONOGRAPH NOT FINAL part333A Yuyao Jessie Commodity Co.,Ltd. BENZALKONIUM CHLORIDE .13 g/100g N 20191231 51414-500_b4b2224e-107c-4ede-9f59-944acd52e97f 51414-500 HUMAN OTC DRUG mouth fresh Cetylpyridinium Chloride SPRAY TOPICAL 20120912 OTC MONOGRAPH NOT FINAL part356 Yuyao Jessie Commodity Co.,Ltd. CETYLPYRIDINIUM CHLORIDE .05 mL/100mL E 20171231 51414-501_62594628-eec0-c96d-e053-2991aa0abeb1 51414-501 HUMAN OTC DRUG mouth fresh Cetylpyridinium Chloride SPRAY TOPICAL 20120912 OTC MONOGRAPH NOT FINAL part356 Yuyao Jessie Commodity Co.,Ltd. CETYLPYRIDINIUM CHLORIDE .05 g/100g N 20191231 51414-600_6208ece6-7eb5-fd36-e053-2991aa0a603c 51414-600 HUMAN OTC DRUG SPF15 sunscreen Octinoxate,oxybenzone,OCTISALATE SPRAY TOPICAL 20120912 OTC MONOGRAPH NOT FINAL part352 Yuyao Jessie Commodity Co.,Ltd. OCTINOXATE; OXYBENZONE; OCTISALATE 4; 4; 2 g/100g; g/100g; g/100g N 20191231 51414-700_6207ccff-c179-d345-e053-2991aa0a803b 51414-700 HUMAN OTC DRUG LENS CLEANER isopropyl alcohol SPRAY TOPICAL 20121128 OTC MONOGRAPH FINAL part344 Yuyao Jessie Commodity Co.,Ltd. ISOPROPYL ALCOHOL 15 g/100g N 20191231 51414-800_620751e6-c2ac-fc5b-e053-2a91aa0ad7d8 51414-800 HUMAN OTC DRUG antibacterial hand sanitizer Benzalkonium Chloride GEL TOPICAL 20140227 OTC MONOGRAPH NOT FINAL part333E Yuyao Jessie Commodity Co.,Ltd. BENZALKONIUM CHLORIDE .25 g/100g N 20191231 51414-900_4bdf44a4-e969-4533-870e-e98ca64bc97b 51414-900 HUMAN OTC DRUG SUNSCREEN STICK Octinoxate,ZINC OXIDE,OCTISALATE SPRAY TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part352 Yuyao Jessie Commodity Co.,Ltd. OCTINOXATE; ZINC OXIDE; OCTISALATE 3; 1; 3 g/100g; g/100g; g/100g E 20171231 51414-901_62076536-47d4-2409-e053-2991aa0ade24 51414-901 HUMAN OTC DRUG Insect String Relief pad Benzocaine,SD alcohol SWAB TOPICAL 20151230 OTC MONOGRAPH NOT FINAL part333E Yuyao Jessie Commodity Co.,Ltd. ALCOHOL; BENZOCAINE 600; 60 mg/g; mg/g N 20191231 51414-902_6207329a-521a-cbcf-e053-2a91aa0a719d 51414-902 HUMAN OTC DRUG Alcohol Cleansing Pad Isopropyl Alcohol SWAB TOPICAL 20151230 OTC MONOGRAPH NOT FINAL part333E Yuyao Jessie Commodity Co.,Ltd. ALCOHOL 700 mg/g N 20191231 51414-903_620623fa-140f-93d0-e053-2a91aa0aaebb 51414-903 HUMAN OTC DRUG GENUINE TRIPLE ANTIBIOTIC bacitracin zinc,neomycin sulfate,polymyxin b sulfate OINTMENT TOPICAL 20160120 OTC MONOGRAPH FINAL part333B Yuyao Jessie Commodity Co.,Ltd. POLYMYXIN B SULFATE; BACITRACIN ZINC; NEOMYCIN SULFATE 5000; 400; 5 [iU]/g; [iU]/g; mg/g N 20191231 51414-904_6207329a-5211-cbcf-e053-2a91aa0a719d 51414-904 HUMAN OTC DRUG GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE benzalkonium chloride, lidocaine CREAM TOPICAL 20160120 OTC MONOGRAPH NOT FINAL part348 Yuyao Jessie Commodity Co.,Ltd. LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE .5; .13 g/100g; g/100g N 20191231 51414-905_6208849c-cdb1-0d40-e053-2a91aa0a432c 51414-905 HUMAN OTC DRUG SUNSCREEN Octinoxate,ZINC OXIDE,OCTISALATE STICK TOPICAL 20140508 OTC MONOGRAPH NOT FINAL part352 Yuyao Jessie Commodity Co.,Ltd. OCTINOXATE; ZINC OXIDE; OCTISALATE 3; 1; 3 g/100g; g/100g; g/100g N 20191231 51417-0001_b11f5de7-9a91-4b52-a0c8-06c47e8ce133 51417-0001 HUMAN OTC DRUG REN Satin Perfection BB Sunscreen Broad Spectrum SPF 15 Light-Medium ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20121026 OTC MONOGRAPH FINAL part352 Ren Ltd. ZINC OXIDE; TITANIUM DIOXIDE 57; 28 mg/mL; mg/mL N 20181231 51417-3340_81103f19-72d2-44e3-8988-fe4a9a00ebe2 51417-3340 HUMAN OTC DRUG ClearCalm 3 Acne Treatment Mask SULFUR CREAM TOPICAL 20100530 OTC MONOGRAPH FINAL part333D Ren Ltd. SULFUR 5 g/100g N 20181231 51417-3341_37b93957-93f9-4ae6-9c89-24ff748ceb56 51417-3341 HUMAN OTC DRUG ClearCalm 3 Anti-Acne Starter SULFUR CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part333D Ren Ltd. SULFUR 5 g/100g N 20181231 51435-001_17f26cc3-8018-40e5-a80a-f33323219020 51435-001 HUMAN OTC DRUG NEUTRACETT ULCER ALLANTOIN GLYCERIN GEL TOPICAL 20100528 OTC MONOGRAPH FINAL part347 ADVANCED BIOMEDICS INC ALLANTOIN; GLYCERIN .5; 50 mg/.1g; mg/g E 20171231 51435-002_cdf18699-0fa4-416f-ba57-a4519713ee71 51435-002 HUMAN OTC DRUG NEUTRACETT TATTOO ALLANTOIN GLYCERIN GEL TOPICAL 20100528 OTC MONOGRAPH FINAL part347 ADVANCED BIOMEDICS INC ALLANTOIN; GLYCERIN .5; 50 mg/.1g; mg/g E 20171231 51435-003_81cba866-6c48-4bcc-9a4b-71639db28533 51435-003 HUMAN OTC DRUG NEUTRACETT ALL PURPOSE ALLANTOIN GLYCERIN GEL TOPICAL 20100528 OTC MONOGRAPH FINAL part347 ADVANCED BIOMEDICS INC ALLANTOIN; GLYCERIN .5; 50 mg/.1g; mg/g E 20171231 51439-001_d12e00d9-1373-4c8e-accc-8c24c2dbd14d 51439-001 HUMAN OTC DRUG Simply Firm Eye - Non-Surgical Face Lift dimethicone gel GEL TOPICAL 20120627 OTC MONOGRAPH FINAL part347 CarePluss Pharma S.A. de C.V. DIMETHICONE .6 mg/60mg E 20171231 51439-002_f1525fc3-925b-44f9-a654-ef41076af283 51439-002 HUMAN OTC DRUG Simply Firm - Face and Neck Non Surgical Face Lift Dimethicone GEL TOPICAL 20120627 OTC MONOGRAPH FINAL part347 CarePluss Pharma S.A. de C.V. DIMETHICONE .00119 mg/.119mg E 20171231 51439-003_1ad3a24f-b2cb-4189-aa4c-b4670bc8d657 51439-003 HUMAN OTC DRUG Simply Firm - Body Gelcreme Dimethicone GEL TOPICAL 20120805 OTC MONOGRAPH FINAL part347 CarePluss Pharma S.A. de C.V. DIMETHICONE .0024 mg/.024mg E 20171231 51439-004_f8f84d20-59c6-4bc7-a048-71a35b22377c 51439-004 HUMAN OTC DRUG Treatment 101 Acne Clearing Treatment Sulphur LIQUID TOPICAL 20120806 OTC MONOGRAPH FINAL part333D CarePluss Pharma S.A. de C.V. SULFUR .003 mg/.06mg E 20171231 51439-005_49d3fb03-dee3-45de-b2ec-caf1443bafd2 51439-005 HUMAN OTC DRUG Cleanser Acne Clearing Treatment Benzoyl Peroxide LIQUID TOPICAL 20120806 OTC MONOGRAPH FINAL part333D CarePluss Pharma S.A. de C.V. BENZOYL PEROXIDE .006 mg/.024mg E 20171231 51439-006_9b4b6abd-2b57-42a9-9d48-4c625358ebd5 51439-006 HUMAN OTC DRUG Tonic Acne Clearing Treatment Salicylic Acid LIQUID TOPICAL 20120806 OTC MONOGRAPH FINAL part333D CarePluss Pharma S.A. de C.V. SALICYLIC ACID .0024 mg/.12mg E 20171231 51439-007_d08e6fbf-9162-47cd-9cf6-74ea24d48214 51439-007 HUMAN OTC DRUG Acne Clearning Treatment Face SULFUR, BENZOYL PEROXIDE, SALICYLIC ACID LIQUID TOPICAL 20120806 OTC MONOGRAPH FINAL part333D CarePluss Pharma S.A. de C.V. SULFUR; BENZOYL PEROXIDE; SALICYLIC ACID .012; .006; .0048 mg/.024mg; mg/.024mg; mg/.024mg E 20171231 51441-003_60276871-18b7-41a9-a041-adc91dcc5449 51441-003 HUMAN OTC DRUG Every Day COCONUT Daily Face Broad Spectrum SPF 15 ZINC OXIDE LOTION TOPICAL 20130424 OTC MONOGRAPH NOT FINAL part352 Agbanga Karite LLC, / EveryDay Shea / Alaffia Sustainable Skin Care ZINC OXIDE 100 mg/mL N 20181231 51442-327_3ef80ca8-79fd-4e32-9319-f48ecbe3e8d3 51442-327 HUMAN OTC DRUG Colgate Junior Bubblefruit Sodium Fluoride GEL, DENTIFRICE DENTAL 20110725 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-330_a0d37acc-6da3-4237-8248-090e49f64230 51442-330 HUMAN OTC DRUG Colgate Toothpaste Great Regular Flavor Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20090604 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 51442-531_3c19876c-8ddb-417f-81e0-7cc3057dfea9 51442-531 HUMAN OTC DRUG Colgate SpongeBob SquarePants Sodium Fluoride GEL, DENTIFRICE DENTAL 20110316 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-531_68aa936b-7ecc-4ced-8b48-87aaad9c4b5e 51442-531 HUMAN OTC DRUG Colgate SpongeBob SquarePants Sodium Fluoride GEL, DENTIFRICE DENTAL 20110718 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-534_934fee9c-1485-4811-8f88-636fc45af1e6 51442-534 HUMAN OTC DRUG Colgate Dora the Explorer Mild Bubblefruit Flavor Sodium Fluoride GEL, DENTIFRICE DENTAL 20110316 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-536_8738dd29-a28f-4e85-9a4f-0ea22bfc89fa 51442-536 HUMAN OTC DRUG Colgate Triple Action Original Mint Fluoride Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100407 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-536_b549e058-9e54-45a7-818a-3975353e160d 51442-536 HUMAN OTC DRUG Colgate Triple Action Original Mint Fluoride Sodium Fluoride PASTE, DENTIFRICE DENTAL 20101117 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-536_dbc41b46-e88d-4d6e-b4a1-f9367f6e5891 51442-536 HUMAN OTC DRUG Colgate Triple Action Original Mint Fluoride Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100407 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-537_67f4a31b-e66a-4478-994d-c49ab6707674 51442-537 HUMAN OTC DRUG Colgate Bakugan Fluoride Mild Bubblefruit Flavor Sodium Fluoride GEL, DENTIFRICE DENTAL 20091118 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-542_d66848fb-1f17-4389-b9c1-8d8684867b30 51442-542 HUMAN OTC DRUG Colgate Proclinical Refreshing Mint Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20091208 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM MONOFLUOROPHOSPHATE 11.4 mg/g E 20171231 51442-543_436f783f-f72e-45fe-8ce5-e652c3cfb3ab 51442-543 HUMAN OTC DRUG COLGATE PROCLINICAL - Sparkling Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20101110 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-543_54178021-35d1-452f-91ae-79ac7ceaa606 51442-543 HUMAN OTC DRUG COLGATE PROCLINICAL - Sparkling Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100409 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-543_f5db5787-7189-4b7c-80d1-c80f83534a5a 51442-543 HUMAN OTC DRUG COLGATE PROCLINICAL - SPARKLING MINT SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20101110 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-544_2b40d7b2-a6d9-477f-8cd1-08abc6af9bb6 51442-544 HUMAN OTC DRUG Colgate Proclinical - Clean Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100125 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-545_3f0b2c46-69df-4417-9b76-9d28a93c161c 51442-545 HUMAN OTC DRUG Colgate Junior - Pink Sparkle Sodium Fluoride GEL, DENTIFRICE DENTAL 20110725 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-546_b378707e-c67c-40ed-b92e-158d21c5fc35 51442-546 HUMAN OTC DRUG Colgate Fluoride Whitening - Reviving Mint Sodium Fluoride GEL, DENTIFRICE DENTAL 20101110 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-546_d5e8f32d-d289-4cbf-80c9-81986498e268 51442-546 HUMAN OTC DRUG COLGATE FLUORIDE WHITENING - REVIVING MINT SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20101110 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-547_0ee4332a-c6c4-4e9c-a586-1d7c96b780ae 51442-547 HUMAN OTC DRUG Colgate Transformers Mild Bubblefruit Flavor Sodium Fluoride GEL, DENTIFRICE DENTAL 20110316 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM FLUORIDE 2.4 mg/g E 20171231 51442-552_a3a8dc1f-df48-4783-a770-297d31d2b131 51442-552 HUMAN OTC DRUG Colgate Optic White - Sparkling Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110606 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 51442-552_b6565f25-7482-4572-a954-991ab1b133fd 51442-552 HUMAN OTC DRUG Colgate Optic White - Sparkling Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110606 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 51442-552_decc5ca8-9818-48d1-ad7d-48662fd769c8 51442-552 HUMAN OTC DRUG Colgate Optic White - Sparkling Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110606 OTC MONOGRAPH FINAL part355 Colgate-Palmolive Canada SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 51444-001_e9885138-6619-4675-83a7-eedadeeca8a8 51444-001 HUMAN OTC DRUG Cold Rub Camphor Eucalyptus Oil Menthol OINTMENT TOPICAL 20100615 OTC MONOGRAPH FINAL part341 JMD All Star Impex Inc. CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.8 g/100g; g/100g; g/100g E 20171231 51444-002_95252cf9-2357-4cc7-b63f-f1c7cca6b99d 51444-002 HUMAN OTC DRUG Blue Ice Menthol GEL TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part348 JMD All Star Impex Inc MENTHOL 2 g/100g E 20171231 51444-003_6d9184c3-c7ba-453c-bd39-33fe6a8207f5 51444-003 HUMAN OTC DRUG Divas Isopropyl Alcohol LIQUID TOPICAL 20100726 OTC MONOGRAPH NOT FINAL part333 JMD All Star Impex Inc ISOPROPYL ALCOHOL 50 mL/100mL E 20171231 51444-004_3e525fe4-9f5e-43d6-aef2-6bc5d4421bda 51444-004 HUMAN OTC DRUG Divas Hydrogen Peroxide LIQUID TOPICAL 20100726 OTC MONOGRAPH NOT FINAL part333 JMD All Star Impex Inc HYDROGEN PEROXIDE 3 mL/100mL E 20171231 51444-005_b4d7cdbf-0a8a-4b1d-b7b5-3ce39d6b5fcf 51444-005 HUMAN OTC DRUG Divas Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20100726 OTC MONOGRAPH NOT FINAL part333 JMD All Star Impex Inc ISOPROPYL ALCOHOL 50 mL/100mL E 20171231 51445-101_877fc49a-0836-4eba-85bb-c8d4241823c9 51445-101 HUMAN OTC DRUG THERABIOGEN COLD AND FLU RELIEF NASAL CAMELIA SINENSIS, SAMBUCUS NIGRA, GELSEMIUM SEMPERVIRENS, BRYONIA ALBA, SULPHUR SPRAY NASAL 20100929 UNAPPROVED HOMEOPATHIC THERABIOGEN GREEN TEA LEAF; SAMBUCUS NIGRA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; BRYONIA ALBA ROOT; SULFUR 3; 2; 6; 6; 12 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL E 20171231 51445-201_450d394b-f4ce-4139-9aa5-c6b6d27caef2 51445-201 HUMAN OTC DRUG THERAMAX ALLERGY RELIEF NASAL CAMELLIA SINENSIS, ALLIUM CEPA, NATRUM MURIATICUM, NUX VOMICA, LUFFA OPERCULATA, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORUM, SULPHUR SPRAY NASAL 20100929 UNAPPROVED HOMEOPATHIC THERABIOGEN GREEN TEA LEAF; ONION; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LUFFA OPERCULATA FRUIT; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; SULFUR 3; 6; 6; 6; 6; 12; 12; 12 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL E 20171231 51447-1256_2e458147-1354-437f-9d62-39ddb2bed7ff 51447-1256 HUMAN OTC DRUG BZK benzalkonium chloride LIQUID TOPICAL 20140716 OTC MONOGRAPH NOT FINAL part333E BIC Graphic USA Manufacturing Co, Inc. BENZALKONIUM CHLORIDE .0013 g/g N 20181231 51452-001_2c011b95-a625-49a4-9e9f-d5d8bc58fccc 51452-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, methyl salicylate GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL; METHYL SALICYLATE 14; 5 mL/120mL; mL/120mL E 20171231 51452-001_2c55ca7c-9d77-4c53-8550-d8adb8652671 51452-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, methyl salicylate GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises METHYL SALICYLATE; MENTHOL .15; .46 L/3.8L; L/3.8L E 20171231 51452-001_501e3f34-2a0d-4b46-8dbe-fb38fe21725e 51452-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, methyl salicylate GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL; METHYL SALICYLATE .6; .2 g/5g; g/5g E 20171231 51452-001_8bdc5379-f2d4-4c2b-affa-8fdd375c7713 51452-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, methyl salicylate GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL; METHYL SALICYLATE 58; 19 mL/480mL; mL/480mL E 20171231 51452-001_ead9ecab-eb28-4ab7-aa51-2665515dbe26 51452-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, methyl salicylate GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL; METHYL SALICYLATE 115; 38 mL/960mL; mL/960mL E 20171231 51452-002_f3dbe088-aa4c-4a3f-a47d-0cddf8d6eb0b 51452-002 HUMAN OTC DRUG Cold Spot Point Relief menthol OINTMENT TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL 13 mL/90mL E 20171231 51452-003_292ef35f-2957-472e-ba68-6cf9e2ea51a2 51452-003 HUMAN OTC DRUG Cold Spot Point Relief menthol AEROSOL, SPRAY TOPICAL 20100824 OTC MONOGRAPH FINAL part341 fabrication enterprises MENTHOL 12 mL/120mL E 20171231 51452-003_37881d6e-e632-49ce-9d01-c3e7a3bd4c62 51452-003 HUMAN OTC DRUG Cold Spot Point Relief menthol AEROSOL, SPRAY TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Fabrication Enterprises MENTHOL 6 mL/60mL E 20171231 51452-003_fbe6ecf2-e153-4ebb-a3bc-7d259cc9528d 51452-003 HUMAN OTC DRUG Cold Spot Point Relief menthol AEROSOL, SPRAY TOPICAL 20100824 OTC MONOGRAPH FINAL part341 fabrication enterprises MENTHOL 48 mL/480mL E 20171231 51452-004_2409526b-8656-40bd-aacc-92ed34dbae76 51452-004 HUMAN OTC DRUG Cold Spot Point Relief MENTHOL SWAB TOPICAL 20111013 OTC MONOGRAPH FINAL part341 Fabrication Enterprises, inc. MENTHOL .96 mL/8mL E 20171231 51452-005_5a2a8dbf-7614-4b9c-a662-65a472413df0 51452-005 HUMAN OTC DRUG Cold Spot Point Relief MENTHOL GEL TOPICAL 20111013 OTC MONOGRAPH FINAL part341 Fabrication Enterprises, inc. MENTHOL; METHYL SALICYLATE 14.4; 4.8 mL/120mL; mL/120mL E 20171231 51452-010_6bc5eb25-fdf2-46e9-b082-e5f513fe4a4c 51452-010 HUMAN OTC DRUG Hot Spot Point Relief capsaicin GEL TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part348 fabrication enterprises CAPSAICIN .5 mL/90mL E 20171231 51452-010_8ce3d37a-9895-4d32-8185-7f24a5be1ad6 51452-010 HUMAN OTC DRUG Hot spot point relief CAPSAICIN GEL TOPICAL 20111013 OTC MONOGRAPH FINAL part348 Fabrication Enterprises, inc. CAPSAICIN .03 mL/5mL E 20171231 51452-010_b6ff1f9c-dc08-4fd5-ad19-08b0bef51f65 51452-010 HUMAN OTC DRUG Hot Spot Point Relief capsaicin GEL TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part348 fabrication enterprises CAPSAICIN 5.8 mL/960mL E 20171231 51452-010_ca3651ed-2554-4696-a744-5e19f604d75f 51452-010 HUMAN OTC DRUG Hot Spot Point Relief capsaicin GEL TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part348 fabrication enterprises CAPSAICIN 1.5 mL/240mL E 20171231 51452-727_6184325f-9809-64ff-e053-2991aa0a1f85 51452-727 HUMAN OTC DRUG Point Relief LidoSpot Lidocaine HCl, Menthol PATCH TOPICAL 20160302 OTC MONOGRAPH NOT FINAL part348 Fabrication Enterprises LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM 4; 1 g/100g; g/100g N 20181231 51456-272_b34b6481-73fd-40af-b7d8-c9b66d984375 51456-272 HUMAN OTC DRUG Benefect Natural Hand Sanitizer Thymol SPRAY TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part347 Sensible Life Products THYMOL .06 mL/120mL E 20171231 51456-299_b34b6481-73fd-40af-b7d8-c9b66d984375 51456-299 HUMAN OTC DRUG Benefect Natural Hand Sanitizer Thymol LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part347 Sensible Life Products THYMOL .5 mL/L E 20171231 51457-000_48bcef3e-6eba-3f84-e054-00144ff88e88 51457-000 HUMAN OTC DRUG Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20120607 OTC MONOGRAPH NOT FINAL part348 Theraplex Solutions MENTHOL; HISTAMINE DIHYDROCHLORIDE 3; .1 g/100g; g/100g N 20181231 51457-001_4923db36-e7a1-592b-e054-00144ff8d46c 51457-001 HUMAN OTC DRUG ALO THERAPEUTIC MASSAGE PAIN RELIEVING MENTHOL, HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20130320 OTC MONOGRAPH NOT FINAL part348 Theraplex Solutions MENTHOL; HISTAMINE DIHYDROCHLORIDE 3; .1 g/100g; g/100g N 20181231 51460-0275_2730d4f5-7ec5-4caf-be4a-b9ca774a35cb 51460-0275 HUMAN OTC DRUG AMERFRESH ANTIBACTERIAL DEODORANT TRICLOCARBAN SOAP TOPICAL 20100903 OTC MONOGRAPH NOT FINAL part333E Amercare Products, Inc. TRICLOCARBAN 1.5 g/100g N 20181231 51460-0502_843e8d6b-8bb6-4c81-8089-8a500ebe6bd4 51460-0502 HUMAN OTC DRUG Amerfresh Sodium Monofluorophosphate POWDER DENTAL 19960101 OTC MONOGRAPH FINAL part355 Amercare Products Inc SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 51460-0504_01111ea5-3692-4b9a-889f-6619fb056913 51460-0504 HUMAN OTC DRUG Amerfresh Medicated Menthol and Zinc Oxide POWDER TOPICAL 20050101 OTC MONOGRAPH FINAL part347 Amercare Products Inc MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g E 20171231 51460-1111_f4796a85-7502-4122-92d5-4c8af32d3273 51460-1111 HUMAN OTC DRUG AmerFresh Sodium Fluoride GEL, DENTIFRICE ORAL 20121114 OTC MONOGRAPH FINAL part355 Amercare Products, Inc. SODIUM FLUORIDE .187 g/85g E 20171231 51460-1112_26239955-403c-4dcd-9e8e-0b36d44a7e01 51460-1112 HUMAN OTC DRUG AmerFresh Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20121114 OTC MONOGRAPH FINAL part355 Amercare Products, Inc. SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 51460-1113_c4e05d34-45f9-4883-9238-628b1562a55b 51460-1113 HUMAN OTC DRUG AmerFresh Sodium Monofluorophosphate POWDER, DENTIFRICE ORAL 20111220 OTC MONOGRAPH FINAL part355 Amercare Products, Inc. SODIUM MONOFLUOROPHOSPHATE .4332 g/57g E 20171231 51460-1114_26239955-403c-4dcd-9e8e-0b36d44a7e01 51460-1114 HUMAN OTC DRUG AmerFresh Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20121114 OTC MONOGRAPH FINAL part355 Amercare Products, Inc. SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 51460-3001_3c7a66a1-44a6-460a-e054-00144ff8d46c 51460-3001 HUMAN OTC DRUG AmerFresh Fluoride Sodium Monofluorophosphate PASTE DENTAL 20160912 OTC MONOGRAPH FINAL part355 Amercare Products, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/g E 20171231 51460-3002_3c7a66a1-449c-460a-e054-00144ff8d46c 51460-3002 HUMAN OTC DRUG AmerFresh Fluoride Sodium Monofluorophosphate PASTE DENTAL 20160912 OTC MONOGRAPH FINAL part355 Amercare Products, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/g E 20171231 51460-3030_3f28a4c7-a6b8-363d-e054-00144ff8d46c 51460-3030 HUMAN OTC DRUG Amerfresh Fluoride SODIUM FLUORIDE PASTE DENTAL 20161012 OTC MONOGRAPH FINAL part355 Amercare Products, Inc. SODIUM FLUORIDE 2.2 mg/g E 20171231 51460-4943_c7638a29-e685-4160-a04b-fc797af08702 51460-4943 HUMAN OTC DRUG AMERFRESH ANTIPERSPIRANT DEODORANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20100706 OTC MONOGRAPH FINAL part350 Amercare Products, Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 51460-4967_9c8aa994-6715-471d-9fc7-b88d21eec369 51460-4967 HUMAN OTC DRUG AMERFRESH ANTIPERSPIRANT DEODORANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20100706 OTC MONOGRAPH FINAL part350 Amercare Products, Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 51460-4974_693175b7-e3b0-4ff1-ad0e-3e5368205ace 51460-4974 HUMAN OTC DRUG AMERFRESH ROLL-ON ANTIPERSPIRANT DEODORANT ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100706 OTC MONOGRAPH FINAL part350 Amercare Products, Inc ALUMINUM CHLOROHYDRATE 1 mL/100mL N 20181231 51460-5000_ce8b2eb8-b3cb-4c19-9308-0a5cb68fa0d2 51460-5000 HUMAN OTC DRUG Amerfresh Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 19960101 OTC MONOGRAPH FINAL part355 Amercare Products Inc SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 51460-5010_27b8a829-d438-439c-b6f5-710cb8e2de7a 51460-5010 HUMAN OTC DRUG Amerfresh Clear Sodium Fluoride PASTE, DENTIFRICE DENTAL 19960101 OTC MONOGRAPH FINAL part355 Amercare Products Inc SODIUM FLUORIDE .22 g/100g E 20171231 51467-005_78de4e4f-09ec-4eab-b1c4-6dca78530664 51467-005 HUMAN OTC DRUG COLTALIN Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride TABLET ORAL 20040301 OTC MONOGRAPH FINAL part341 FORTUNE PHARMACAL COMPANY LIMITED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 51467-006_fa8ca38c-41d8-475d-8d52-cef0fa36635a 51467-006 HUMAN OTC DRUG CHILDRENS COLTALIN ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, CHEWABLE ORAL 20040301 OTC MONOGRAPH FINAL part341 FORTUNE PHARMACAL COMPANY LIMITED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 80; .5; 1.25 mg/1; mg/1; mg/1 N 20181231 51467-007_fdffc58e-304a-41b6-84fa-e44506aa5f44 51467-007 HUMAN OTC DRUG COLTALIN-DM ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20040301 OTC MONOGRAPH FINAL part341 FORTUNE PHARMACAL COMPANY LIMITED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 51467-008_41d2cd7a-e027-40cd-a111-c633c76f2e82 51467-008 HUMAN OTC DRUG COLTALIN-ND ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20040301 OTC MONOGRAPH FINAL part341 FORTUNE PHARMACAL COMPANY LIMITED ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 51467-009_7cf8cbb2-cfc8-457b-a530-ec35a2575e7f 51467-009 HUMAN OTC DRUG EXCAUGH Guaifenesin TABLET ORAL 20160426 OTC MONOGRAPH FINAL part341 FORTUNE PHARMACAL COMPANY, LIMITED GUAIFENESIN 100 mg/1 N 20181231 51467-010_d5cfcaf4-ba44-40e0-bf43-5555d1b135b0 51467-010 HUMAN OTC DRUG Extra Fast Coltalin Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride TABLET ORAL 20170404 OTC MONOGRAPH FINAL part341 FORTUNE PHARMACAL COMPANY LIMITED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 51467-100_e81af63d-c428-4fca-b864-1cc586b72b75 51467-100 HUMAN OTC DRUG MAGSIL ANTACID (LEMON MINT) Aluminum Hydroxide Dried Gel, Magnesium Hydroxide, and Simethicone TABLET, CHEWABLE ORAL 20170920 OTC MONOGRAPH FINAL part331 FORTUNE PHARMACAL COMPANY LIMITED ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 21 mg/1; mg/1; mg/1 N 20181231 51467-101_b44d3b25-671a-4a8d-87a5-62cd4b71b2a6 51467-101 HUMAN OTC DRUG SPRINSOL Chlorpheniramine maleate TABLET ORAL 20170922 OTC MONOGRAPH FINAL part341 FORTUNE PHARMACAL COMPANY LIMITED CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 51467-127_b5f2af89-8122-4675-af32-0223b66865c0 51467-127 HUMAN OTC DRUG FORTOLIN ACETAMINOPHEN TABLET ORAL 20040301 OTC MONOGRAPH NOT FINAL part343 FORTUNE PHARMACAL COMPANY, LIMITED ACETAMINOPHEN 500 mg/1 E 20171231 51477-001_0dda86e7-da48-49ba-8fdb-102d546d35e6 51477-001 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20101025 NDA AUTHORIZED GENERIC NDA018238 Nesher Pharmaceuticals (USA) LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 51477-002_0dda86e7-da48-49ba-8fdb-102d546d35e6 51477-002 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20101025 NDA AUTHORIZED GENERIC NDA018238 Nesher Pharmaceuticals (USA) LLC POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 51483-002_6e3069bd-e7ef-4f98-a0c7-18b7ce943776 51483-002 HUMAN OTC DRUG Burn-B Gone OTC Allantoin GEL TOPICAL 20100601 OTC MONOGRAPH FINAL part347 DeWitt Laboratories, Inc ALLANTOIN .75 g/75g E 20171231 51486-002_501798ab-106b-4b1b-b6e1-22014ed928ab 51486-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20100101 NDA NDA205866 ILMO Products Company NITROGEN 990 mL/L N 20181231 51486-003_267259c1-4acc-4248-82c3-ee0ff0da4b3f 51486-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS ILMO Products Company NITROUS OXIDE 990 mL/L E 20171231 51486-004_76d7bfb2-ea92-491c-bbcb-e4ebfaa44775 51486-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20090101 UNAPPROVED MEDICAL GAS ILMO Products Company AIR 1000 mL/L E 20171231 51486-005_a0851c49-3eda-43cc-978a-1f37af683fa5 51486-005 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20120501 NDA NDA205852 ILMO Products Company CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 51486-007_60bddcb5-be33-0d24-e053-2991aa0abb62 51486-007 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20120501 NDA NDA206009 ILMO Products Company NITROUS OXIDE 990 mL/L N 20181231 51486-015_96c5713f-e9e3-496e-8729-6723ef3b5baf 51486-015 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20161006 UNAPPROVED MEDICAL GAS ILMO Products Company CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 51486-018_60df3c7f-8744-79c2-e053-2a91aa0acdec 51486-018 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20090101 NDA NDA205865 ILMO Products Company OXYGEN 210 mL/L N 20181231 51486-720_d2359b18-d35b-452c-a8f6-c95fb5941a00 51486-720 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900101 NDA NDA205865 ILMO Products Company OXYGEN 990 mL/L N 20181231 51500-001_468b2c3d-cbe9-4565-bcc0-0b38b2d2f5bd 51500-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140101 NDA NDA205849 Corsicana Welding Supply, Inc. OXYGEN 990 mL/L N 20181231 51511-514_0ce3d56c-6195-4eee-bb7c-d3a9392c96b6 51511-514 HUMAN OTC DRUG Salicylic Acid Corn Remover Salicylic Acid STRIP TOPICAL 20100201 OTC MONOGRAPH FINAL part358B ASO Pharmaceutical Co. Ltd. SALICYLIC ACID 40 mg/1 N 20181231 51511-596_ec2bebf0-0f7d-48e3-9c9f-27aa1708096a 51511-596 HUMAN OTC DRUG Salicylic Acid Wart Remover Salicylic Acid STRIP TOPICAL 20090201 OTC MONOGRAPH FINAL part358H ASO Pharmaceutical Co. Ltd. SALICYLIC ACID 40 mg/1 N 20181231 51514-0205_5865f784-16c1-46b0-8b1a-7c58d95adaab 51514-0205 HUMAN OTC DRUG GAP Favorite Lip Balm Juicy Pear SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111116 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g E 20171231 51514-0212_fb302cea-25fd-4bc0-95e5-44a331dc7cd4 51514-0212 HUMAN OTC DRUG GAP Favorite Lip Balm Citrus Splash SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111116 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g E 20171231 51514-0213_7a16cb98-bd5b-4440-b3a7-d358ee39adeb 51514-0213 HUMAN OTC DRUG Gap favorite Lip Balm Strawberry Kiwi Octinoxate and Oxybenzone STICK TOPICAL 20111117 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g E 20171231 51514-0214_fc3ac297-caf8-4d57-baab-b6a63b60ca25 51514-0214 HUMAN OTC DRUG GAP Favorite Lip Balm Creamy Pomegranate SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111121 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g E 20171231 51514-0215_c679096d-25ca-4381-aed0-111701137af7 51514-0215 HUMAN OTC DRUG Gap Favorite Lip Balm Vanilla Mint SPF Octinoxate and Oxybenzone STICK TOPICAL 20111117 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc. OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g E 20171231 51514-0217_ec87de8a-37d4-4074-8538-e721380ee5b4 51514-0217 HUMAN PRESCRIPTION DRUG GAP Favorite Lip Balm Berry Punch SPF 18 Octinoxate and Oxybezone STICK TOPICAL 20111121 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g E 20171231 51514-0218_b8815d31-bc15-4afd-8f86-3f8564eda7d0 51514-0218 HUMAN OTC DRUG GAP Favorite Lip Balm Pomegranate SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111116 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g E 20171231 51514-0219_10173658-2081-4683-a717-7ff8219136fe 51514-0219 HUMAN OTC DRUG GAP Favorite Lip Balm Tropical Twist SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111121 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g E 20171231 51514-0220_ee4cf10e-c704-4ab0-a724-78979568dd79 51514-0220 HUMAN OTC DRUG GAP Favorite Lip Balm Watermelon SPF Octinoxate and Oxybenzone STICK TOPICAL 20111129 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc. OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g E 20171231 51514-0221_74f90a1d-d5fa-45c9-9961-e8995888c4e6 51514-0221 HUMAN OTC DRUG Yes to Carrots Sweet Fig SPF15 Zinc Oxide STICK TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Autumn Harp ZINC OXIDE 6.5 g/100g E 20171231 51514-0223_bc21e31a-3343-4126-ae58-401327739921 51514-0223 HUMAN OTC DRUG GAP favorite Lip Balm Green Apple SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111206 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g E 20171231 51514-0227_d70f1df9-31eb-49d2-b024-155777946247 51514-0227 HUMAN OTC DRUG GAP Favorite Lip Balm Apple Pie SPF 18 Octinoxate and Oxybenzone STICK TOPICAL 20111208 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc OCTINOXATE; OXYBENZONE 7.5; 6 g/100g; g/100g E 20171231 51514-0235_e1218602-18ec-4010-acd9-658608a55d11 51514-0235 HUMAN OTC DRUG Babyganics SPF 50 Octinoxate, Octisalate, and Zinc SPRAY TOPICAL 20120223 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc. ZINC OXIDE; OCTINOXATE; OCTISALATE 11.2; 7.5; 5 mL/100mL; mL/100mL; mL/100mL E 20171231 51514-0236_fadc97b3-9d98-49ca-8151-4d4a1784843a 51514-0236 HUMAN OTC DRUG Desert Essence Mineral Sunscreen SPF 35 Zinc Oxide CREAM TOPICAL 20130715 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 15 g/100g E 20171231 51514-0303_2bab63e9-ca01-4cf7-af4e-3d2d106f9bb3 51514-0303 HUMAN OTC DRUG Alba TerraTint Bloom SPF 15 Lip Balm Zinc Oxide STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 5.5 g/100g E 20171231 51514-0304_374b5d5c-2bbb-4106-a804-ff355ab75105 51514-0304 HUMAN OTC DRUG Alba TerraTint Garnet SPF 15 Lip Balm Zinc Oxide STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 5.5 g/100g E 20171231 51514-0305_a1e1d4b4-9e71-4599-b3dd-920938d760d8 51514-0305 HUMAN OTC DRUG Alba TerraTint Blaze SPF 15 Lip Balm Zinc Oxide STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 5.5 g/100g E 20171231 51514-0306_06100db1-4158-4b92-9413-d29cec8dcc13 51514-0306 HUMAN OTC DRUG Alba Very Emollient Sunscreen Lip Care SPF25 Octocrylene, Octinoxate, Octisalate, Zinc Oxide STICK TOPICAL 20120401 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTOCRYLENE; OCTINOXATE; OCTISALATE; ZINC OXIDE 10; 7.5; 1; 3.7 g/100g; g/100g; g/100g; g/100g E 20171231 51514-0307_8b61ef0a-ae74-4347-8cfd-52da928fb227 51514-0307 HUMAN OTC DRUG YesTo Pomegranate Lip Butter with SPF 15 Zinc Oxide STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE 7.6 g/100g E 20171231 51514-0315_8f3e090a-3d0e-479c-ac5b-8a3dd69ecc00 51514-0315 HUMAN OTC DRUG Yes To Cucumbers Natural Sunscreen SPF 30 Stick Zinc Oxide, Titanium Dioxide STICK TOPICAL 20130111 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE; TITANIUM DIOXIDE 10.8; 4.9 g/100g; g/100g E 20171231 51514-0316_2d684392-63bd-4cc6-8412-7d12b244680b 51514-0316 HUMAN OTC DRUG Yes To Cucumbers Natural Sunscreen SPF 40 Kids Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20121230 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE; TITANIUM DIOXIDE 11.7; 5.5 g/100mL; g/100mL E 20171231 51514-0317_758659ed-1519-4a12-b5ca-b510344486c5 51514-0317 HUMAN OTC DRUG Yes To Grapefruit Moisturizer with SPF15 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20121114 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE; TITANIUM DIOXIDE 3.2; 2.9 mg/100mL; mg/100mL E 20171231 51514-0318_d806c4c7-0eaa-47bf-a424-0bdfe08f3a43 51514-0318 HUMAN OTC DRUG Yes To Cucumbers Natural Sunscreen SPF 30 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20130101 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE; TITANIUM DIOXIDE 11; 6.2 g/100g; g/100g E 20171231 51514-0319_aab342e3-7422-4699-8a16-73191285480b 51514-0319 HUMAN OTC DRUG Urban Decay Naked Skin Beauty Balm SPF 20 Octinoxate, Zinc Oxide LOTION TOPICAL 20130712 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; ZINC OXIDE 7.5; 3.4 mg/100mL; mg/100mL E 20171231 51514-0320_3a48f672-c3fe-4ade-9549-a7bf7552aeb7 51514-0320 HUMAN OTC DRUG Yes To Carrots Sweet Fig Lip Butter with SPF 15 Zinc Oxide STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc ZINC OXIDE 7.6 g/100g E 20171231 51514-0321_01072a9e-6de2-4c1b-ac13-f980994516bd 51514-0321 HUMAN OTC DRUG Yes To Cucumbers Daily Moisturizer SPF 30 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20130206 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE; TITANIUM DIOXIDE 11; 6.2 mg/100mL; mg/100mL E 20171231 51514-0322_a27a7f76-5ba8-4258-a9fa-a346075c5cd3 51514-0322 HUMAN OTC DRUG Yes To Blueberries Daily Repairing Moisturizer SPF30 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20130322 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE; TITANIUM DIOXIDE 11; 6.2 mg/100mL; mg/100mL E 20171231 51514-0323_94cde319-7aa2-4cbe-804e-6e911c8638f3 51514-0323 HUMAN OTC DRUG Yes To Carrots Daily Facial Moisturizer SPF 15 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20130430 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE; TITANIUM DIOXIDE 3.2; 2.9 mg/100mL; mg/100mL E 20171231 51514-0324_6e4cd232-2f23-4b65-9158-70e358035e3a 51514-0324 HUMAN OTC DRUG YES TO GRAPEFRUIT CC CREAM - LIGHT/MEDIUM Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130619 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc ZINC OXIDE; TITANIUM DIOXIDE 3.2; 2.9 mg/100mL; mg/100mL E 20171231 51514-0325_6948797b-f5c7-4376-942d-913e9ff5a477 51514-0325 HUMAN OTC DRUG YES TO GRAPEFRUIT CC CREAM - LIGHT Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130415 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc ZINC OXIDE; TITANIUM DIOXIDE 3.2; 2.9 mg/100mL; mg/100mL E 20171231 51514-0326_14a16b35-c86b-4368-806e-bc38c973c94a 51514-0326 HUMAN OTC DRUG YES TO CARROTS FRAGRANCE-FREE DAILY FACIAL MOISTURIZER SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130613 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc ZINC OXIDE; TITANIUM DIOXIDE 3.2; 2.9 mg/100mL; mg/100mL E 20171231 51514-0327_52a0349e-f327-4681-9491-d38cf5ce7776 51514-0327 HUMAN OTC DRUG YES TO TOMATOES ROLLER BALL SPOT STICK Salicylic Acid SOLUTION TOPICAL 20110112 OTC MONOGRAPH FINAL part333D Autumn Harp, Inc. SALICYLIC ACID 2 mg/100mL E 20171231 51514-0328_5de6b069-fa7b-42fa-a68e-64b28fa9c07b 51514-0328 HUMAN OTC DRUG YES TO TOMATOES DAILY PORE SCRUB Salicylic Acid CREAM TOPICAL 20110113 OTC MONOGRAPH FINAL part333D Autumn Harp, Inc. SALICYLIC ACID 2 g/100g E 20171231 51514-0329_b2166f8a-0db3-4a61-8827-41d7ea4cac41 51514-0329 HUMAN OTC DRUG YES TO TOMATOES ACNE CONTROL GEL CLEANSER Salicylic Acid GEL TOPICAL 20111027 OTC MONOGRAPH FINAL part333D Autumn Harp, Inc. SALICYLIC ACID 1 g/100mL E 20171231 51514-0330_f5e8b855-707e-4624-86e3-c1b85f5e41dd 51514-0330 HUMAN OTC DRUG Yes To Tomatoes Daily Repair Treatment Salicylic Acid GEL TOPICAL 20130411 OTC MONOGRAPH FINAL part333D Autumn Harp, Inc. SALICYLIC ACID 1 mg/100mL E 20171231 51514-0331_6ac92a0a-fcc0-4c05-8bee-d741f46afbb5 51514-0331 HUMAN OTC DRUG Urban Decay Naked Skin Light Beauty Balm SPF20 Octinoxate, Zinc Oxide LOTION TOPICAL 20140109 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; ZINC OXIDE 7.5; 3.4 mg/100mL; mg/100mL E 20171231 51514-0332_ded5c521-cdfa-4c5f-8f84-5fd202204a52 51514-0332 HUMAN OTC DRUG Josie Maran Argan Daily Moisturizer SPF47 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20140109 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE; TITANIUM DIOXIDE 6.4; 5.1 mg/100mL; mg/100mL E 20171231 51514-0333_3be87ace-b30b-4b05-b4d8-fd4aa4f0eb8d 51514-0333 HUMAN OTC DRUG Urban Decay Naked Skin Dark Beauty Balm SPF20 Octinoxate, Zinc Oxide LOTION TOPICAL 20130805 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; ZINC OXIDE 7.5; 3.4 mg/100mL; mg/100mL E 20171231 51514-0334_08b4927b-8b1d-3061-e054-00144ff8d46c 51514-0334 HUMAN OTC DRUG Urban Decay Naked Skin Bronzing Beauty Balm SPF 20 Octinoxate, Zinc Oxide LOTION TOPICAL 20130927 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; ZINC OXIDE 7.5; 3.4 mg/100mL; mg/100mL E 20171231 51514-0335_08b4927b-8b2e-3061-e054-00144ff8d46c 51514-0335 HUMAN OTC DRUG Urban Decay Naked Skin Illuminating Beauty Balm SPF20 Octinoxate, Zinc Oxide LOTION TOPICAL 20130805 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; ZINC OXIDE 7.5; 3.4 mg/100mL; mg/100mL E 20171231 51514-0336_3153033b-7552-4484-a4db-f403330ef2ee 51514-0336 HUMAN OTC DRUG LIP CARE SPF 15 WITH VITAMIN E Octinoxate, Oxybenzone STICK TOPICAL 20040820 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTINOXATE; OXYBENZONE 7.5; 5 g/100g; g/100g E 20171231 51514-0337_2865f218-0c89-4b93-a811-39bad63cdc67 51514-0337 HUMAN OTC DRUG Josie Maran Argan Daily Moisturizer SPF47 Protect and Perfect Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20140305 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. ZINC OXIDE; TITANIUM DIOXIDE 9.4; 5.9 mg/100mL; mg/100mL E 20171231 51514-0338_086b6d24-c552-4eb2-a405-ff1be677af5f 51514-0338 HUMAN OTC DRUG Desert Essence Dont Be Rash Diaper Cream Zinc Oxide CREAM TOPICAL 20110609 OTC MONOGRAPH FINAL part347 Autumn Harp, Inc. ZINC OXIDE 12 g/100mL E 20171231 51514-0339_05f3d444-93fb-54a7-e054-00144ff8d46c 51514-0339 HUMAN OTC DRUG Yes To Tomatoes Clear Skin Corrective Concealer Light Tint Salicylic Acid Concealer Stick STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part333D Autumn Harp Incorporated SALICYLIC ACID 1 g/100g E 20171231 51514-0342_2ea1edb3-d8b4-1e8a-e054-00144ff88e88 51514-0342 HUMAN OTC DRUG Vitamin E SPF15 Lip Balm Avobenzone, Octisalate, Octocrylene STICK TOPICAL 20130313 OTC MONOGRAPH FINAL part352 Autumn Harp, Inc. OCTISALATE; OCTOCRYLENE; AVOBENZONE 5; 3; 2 g/100g; g/100g; g/100g E 20171231 51514-0343_31f614e2-9299-0c47-e054-00144ff8d46c 51514-0343 HUMAN OTC DRUG Naked One and Done Cream Light SPF Cream CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part352 Autumn Harp Inc. OCTINOXATE; ZINC OXIDE 7.49; 3.43 g/100g; g/100g E 20171231 51514-0344_342555a1-2134-478a-e054-00144ff8d46c 51514-0344 HUMAN OTC DRUG Naked Skin One and Done, Medium Light SPF Cream CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part352 Autumn Harp Inc. OCTINOXATE; ZINC OXIDE 7.49; 3.43 g/100g; g/100g E 20171231 51514-0345_344c0897-32ff-1fb6-e054-00144ff8d46c 51514-0345 HUMAN OTC DRUG Naked Skin One and Done, Medium SPF Cream CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part352 Autumn Harp Inc. OCTINOXATE; ZINC OXIDE 7.5; 3.4 g/100g; g/100g E 20171231 51514-0346_3460ef52-93b8-2f0c-e054-00144ff8d46c 51514-0346 HUMAN OTC DRUG Naked Skin One and Done, Medium Dark SPF Cream CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part352 Autumn Harp Inc. ZINC OXIDE; OCTINOXATE 3.4; 7.5 g/100g; g/100g E 20171231 51514-0347_3464086a-0310-4532-e054-00144ff88e88 51514-0347 HUMAN OTC DRUG Naked Skin One and Done Dark SPF Cream CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part352 Autumn Harp Inc. ZINC OXIDE; OCTINOXATE 3.4; 7.5 g/100g; g/100g E 20171231 51514-0348_34654cec-f0b7-1d9a-e054-00144ff8d46c 51514-0348 HUMAN OTC DRUG Naked Skin One and Done Deep SPF Cream CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part352 Autumn Harp Inc OCTINOXATE; ZINC OXIDE 7.5; 3.4 g/100g; g/100g E 20171231 51514-0352_376dcf11-a1f0-46a9-e054-00144ff88e88 51514-0352 HUMAN OTC DRUG Daily Protecting SPF15 Sunscreen Lotion LOTION TOPICAL 20160831 OTC MONOGRAPH FINAL part352 Autumn Harp Inc. ZINC OXIDE 10 g/100g E 20171231 51514-0353_3d9385d0-6ef9-3d37-e054-00144ff88e88 51514-0353 HUMAN OTC DRUG Promise Organics Diaper Cream Diaper Cream CREAM TOPICAL 20170322 OTC MONOGRAPH FINAL part347 Autumn Harp Incorporated ZINC OXIDE 14 g/100g E 20171231 51514-201_06b61907-1137-428b-983c-6b87daf0becb 51514-201 HUMAN OTC DRUG Badger SPF30 Unscented Sunscreen Unscented Zinc Oxide OINTMENT TOPICAL 20111110 OTC MONOGRAPH NOT FINAL part352 Autumn Harp, Inc. ZINC OXIDE 18.75 mL/100mL E 20171231 51523-001_326d3e0f-a911-4b28-a706-e18dee450dc1 51523-001 HUMAN OTC DRUG ARSAINTE ECO THERAPY SUPER REPAIR BB SPF20 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 4.64 mL/50mL E 20171231 51523-002_1c49c462-a7be-48b9-8b25-cce51f3aa1ff 51523-002 HUMAN OTC DRUG ARSAINTE ECO THERAPY SUPER REPAIR SUN SPF45 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 5.55; 4.36 mL/50mL; mL/50mL E 20171231 51523-003_5cb718c5-33a1-4522-9b06-3ad7e5123cad 51523-003 HUMAN OTC DRUG QUICK AND CLEAN OIL FREE SUN SPF35 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20090101 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 2.59 g/50g E 20171231 51523-004_26511f13-52e4-4f15-af38-3b84e0fff4c3 51523-004 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC FOUNDATION SPF20 PA NB21 TITANIUM DIOXIDE CREAM CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 4.01 mL/35mL E 20171231 51523-005_8e6610c1-c1be-4740-b692-322f14c94bd0 51523-005 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC FOUNDATION SPF20 PA NB23 TITANIUM DIOXIDE CREAM CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 4.01 mL/35mL E 20171231 51523-006_932f99eb-aafe-40f6-99cf-f81692002fca 51523-006 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC MAKE UP BASE SPF20 PA 01GREEN TITANIUM DIOXIDE CREAM CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.81; 1.41 mL/35mL; mL/35mL E 20171231 51523-007_ff93b65a-7905-421b-ad13-9edf024362d1 51523-007 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC SKIN COVER SPF20 PA NB21 TITANIUM DIOXIDE CREAM CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 2.35 g/10g E 20171231 51523-008_b104d6e5-9452-4844-806f-3f5dfa86dbde 51523-008 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC SKIN COVER SPF20 PA NB23 TITANIUM DIOXIDE POWDER CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 2.35 g/10g E 20171231 51523-009_78671884-de9d-485e-88b0-d4c2a329d96d 51523-009 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC TWO WAY CAKE SPF17 PA NB21 TITANIUM DIOXIDE POWDER CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE .93; .17 g/12g; g/12g E 20171231 51523-010_68540c8a-bb3a-40cc-aa8c-c551b6c1fee1 51523-010 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC TWO WAY CAKE SPF17 PA NB23 TITANIUM DIOXIDE POWDER CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE .93; .17 g/12g; g/12g E 20171231 51523-011_1db6323e-7193-4e31-886b-098710b42e53 51523-011 HUMAN OTC DRUG FLEBEAUTE COLLAGENIC TWO WAY CAKE SPF17 PA NB25 TITANIUM DIOXIDE POWDER CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE .93; .17 g/12g; g/12g E 20171231 51523-012_2c75cdc9-d568-4d54-84d5-9447395ebd7f 51523-012 HUMAN OTC DRUG HYDRO SPLASH BB SPF20 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20080701 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 4.48 g/45g E 20171231 51523-013_a8fe4224-534a-4f74-98c4-45bc52b9b7be 51523-013 HUMAN OTC DRUG MYUNG HAN MI IN DO FOUNDATION SPF20 PA NB21 TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 4.01 mL/35mL E 20171231 51523-014_a08b3f2d-8b73-46b7-b350-913f866bf3ad 51523-014 HUMAN OTC DRUG MYUNG HAN MI IN DO FOUNDATION SPF20 PA NB23 TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 4.01 mL/35mL E 20171231 51523-015_b26e4159-a3cb-4abd-a433-4fb62bd96d57 51523-015 HUMAN OTC DRUG MYUNG HAN MI IN DO MAKEUP BASE SPF20 PA 01 GREEN TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.19 mL/35mL E 20171231 51523-016_51bee26b-ae24-4de9-b97b-059bf85590ff 51523-016 HUMAN OTC DRUG MYUNG HAN MI IN DO RECOVERY BB SPF25 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.87; .86 g/45g; g/45g E 20171231 51523-017_e8b24316-a3a8-47c8-9d06-5cac7e3d58e7 51523-017 HUMAN OTC DRUG MYUNG HAN MI IN DO TWO WAY CAKE SPF35 PA NB21 TITANIUM DIOXIDE POWDER CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.02; .35 g/12g; g/12g E 20171231 51523-018_5644ca3b-0bc1-47a1-9e91-642c28bac555 51523-018 HUMAN OTC DRUG MYUNG HAN MI IN DO TWO WAY CAKE SPF35 PA NB23 TITANIUM DIOXIDE POWDER CUTANEOUS 20090401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.02; .35 g/12g; g/12g E 20171231 51523-019_77bfc4ad-f2e5-4f77-a0f0-2de3c43cc780 51523-019 HUMAN OTC DRUG NEO CLASSIC HOMME BB SPF20 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.45 mL/50mL E 20171231 51523-020_a7768b4b-d439-47de-9ded-8b3f8757b13d 51523-020 HUMAN OTC DRUG NATURAL SUN AQ POWER LONG LASTING SUN SPF45 PA ZINC OXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE 5.5; 2.25 mL/50mL; mL/50mL E 20171231 51523-021_f12a8cdc-3f0c-45b1-bdc1-ba31fbe2e441 51523-021 HUMAN OTC DRUG NATURAL SUN AQ SUPER PERFECT SUN SPF50 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.36 mL/50mL E 20171231 51523-022_4c2ad6f4-78e0-4d04-83d2-67011e511480 51523-022 HUMAN OTC DRUG NATURAL SUN AQ SUPER WHITE SUN SPF50 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.36 mL/50mL E 20171231 51523-023_60b44338-edd9-4ea6-b125-17940fd7e140 51523-023 HUMAN OTC DRUG THE FLOWER UV INTENSE PACT SPF50 PA NB21 ZINC OXIDE POWDER CUTANEOUS 20070301 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE 1.64; 1.53 g/12g; g/12g E 20171231 51523-024_857b67c5-e604-4d28-94d6-39ef99413919 51523-024 HUMAN OTC DRUG THE FLOWER UV INTENSE PACT SPF50 PA NB23 ZINC OXIDE POWDER CUTANEOUS 20070301 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE 1.65; 1.54 g/12g; g/12g E 20171231 51523-025_e931f1f2-3e97-465f-8745-f37bc631bdbe 51523-025 HUMAN OTC DRUG THE SKIN EXTRA BB SPF20 PA TITANIUM DIOXIDE CREAM CUTANEOUS 20090101 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE .81 g/45g E 20171231 51523-026_76a14fab-5160-45f3-978b-42232285ad67 51523-026 HUMAN OTC DRUG PHYTOGENIC INFINITE FOUNDATION SPF20 NB21 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 3.25 mL/35mL E 20171231 51523-027_15b5fecd-0b4d-4851-a8b8-bfa3e8dd9847 51523-027 HUMAN OTC DRUG PHYTOGENIC INFINITE FOUNDATION SPF20 NB23 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 3.25 mL/35mL E 20171231 51523-028_125c26f7-a54a-49c3-a1d8-dd90ddaf8e2e 51523-028 HUMAN OTC DRUG PHYTOGENIC INFINITE FOUNDATION SPF20 NB25 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 3.25 mL/35mL E 20171231 51523-029_4fb22d75-0019-417d-9381-3840a6847bca 51523-029 HUMAN OTC DRUG PHYTOGENIC INFINITE MAKEUP BASE SPF15 GREEN TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.23; .93 mL/35mL; mL/35mL E 20171231 51523-030_d4808c5b-c3af-4a3e-96fa-6391eda39b8a 51523-030 HUMAN OTC DRUG PHYTOGENIC INFINITE MAKEUP BASE SPF15 PURPLE TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.23; .93 mL/35mL; mL/35mL E 20171231 51523-031_0c572d40-83f7-40bb-ab4a-90eaf4a46dfc 51523-031 HUMAN OTC DRUG PHYTOGENIC INFINITE POWDER FOUNDATION SPF20 NB21 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.68 g/12g E 20171231 51523-032_7beab07e-971f-4403-b66d-5f5d94f89e28 51523-032 HUMAN OTC DRUG PHYTOGENIC INFINITE POWDER FOUNDATION SPF20 RB23 TITANIUM DIOXIDE POWDER CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.68 g/12g E 20171231 51523-033_e1bca880-9091-4fab-9b4e-a5b2990d7d3a 51523-033 HUMAN OTC DRUG PHYTOGENIC INFINITE POWDER FOUNDATION SPF20 NB25 TITANIUM DIOXIDE POWDER CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.68 g/12g E 20171231 51523-034_84df31bc-88fa-4b6d-88c7-7b90dbf4bbd8 51523-034 HUMAN OTC DRUG PHYTOGENIC INFINITE POWDER FOUNDATION SPF20 NB23 TITANIUM DIOXIDE POWDER CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 1.68 g/12g E 20171231 51523-042_0fed0008-653f-3728-e054-00144ff88e88 51523-042 HUMAN OTC DRUG LOVELY ME EX 32900042 avobenzone, ensulizole, octinoxate and titanium dioxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; ENSULIZOLE; AVOBENZONE; TITANIUM DIOXIDE 2.4; .8; .32; .36 g/40mL; g/40mL; g/40mL; g/40mL E 20171231 51523-100_df137887-b544-427f-a316-61f3cb43afab 51523-100 HUMAN OTC DRUG Myung Han Miindo Make Up Base OCTINOXATE LIQUID TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ENSULIZOLE; AVOBENZONE 6; 3.4; 2; .8 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 51523-101_b7e93fdb-4412-4271-b379-8d07992f0e82 51523-101 HUMAN OTC DRUG NATURAL SUN AQ BODY AND FAMILY MILD SUN MILK OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AVOBENZONE, ENZACAMENE CREAM TOPICAL 20101122 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; AVOBENZONE; ENZACAMENE 7.5; 3; 2.34; 2.3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 51523-102_18ca4674-e8d7-47f8-847f-74bf1c0cef9b 51523-102 HUMAN OTC DRUG NATURAL SUN AQ TOTAL ANTI-AGING ESSENCE SUN OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AVOBENZONE, ENZACAMENE, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20101122 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; AVOBENZONE; ENZACAMENE; NIACINAMIDE; ADENOSINE 7.5; 3; 2.34; 2.3; 2; 2; .4 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 51523-103_0ccce2d2-82a7-4e12-a2e5-7ffce3cd5aba 51523-103 HUMAN OTC DRUG FACE IT HD PERFECT BB SPF30 PA 01 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, BETAINE, TALC CREAM TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE; BETAINE; TALC 6; 6.36; 2.88; 2; .684 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 51523-104_bea9f699-bc6f-4b53-b4f5-8be1d1f2f91b 51523-104 HUMAN OTC DRUG FACE IT HD PERFECT BB SPF30 PA 02 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, BETAINE, TALC CREAM TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE; BETAINE; TALC 6; 6.36; 2.88; 2; .684 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 51523-105_97b6d7bf-8212-4a0d-9a6b-5bacaaaf2fa8 51523-105 HUMAN OTC DRUG FACE IT AQUA TINTED BB SPF 20 PA 01 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD TITANIUM DIOXIDE; OCTINOXATE 5.8; 5 mL/100mL; mL/100mL E 20171231 51523-106_0d7fea65-9b75-4cac-896f-3fd0753db2bf 51523-106 HUMAN OTC DRUG FACE IT AQUA TINTED BB SPF 20 PA 02 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD TITANIUM DIOXIDE; OCTINOXATE 5.8; 5 mL/100mL; mL/100mL E 20171231 51523-109_5c154dbd-714f-4821-8535-3494703f8561 51523-109 HUMAN OTC DRUG FACE IT 4D PERFECTION ROLLER FOUNDATION 21 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE 3; 23.51 g/100g; g/100g E 20171231 51523-110_96db1182-bb49-4764-b468-5ff9c1b62712 51523-110 HUMAN OTC DRUG FACE IT 4D PERFECTION ROLLER FOUNDATION 23 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE 3; 23.51 g/100g; g/100g E 20171231 51523-111_8dd2bd05-23cb-4497-8e21-04bff43b7e19 51523-111 HUMAN OTC DRUG FACE IT OIL CUT DUAL BB EMULSION SPF20 TITANIUM DIOXIDE CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD TITANIUM DIOXIDE 10 mL/100mL E 20171231 51523-112_167fa68f-dfcf-4fd2-86df-4c1e8a23290e 51523-112 HUMAN OTC DRUG FACE IT Radiance Two Way Cake NB21 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 12.8784; 2; 1.4775 g/100g; g/100g; g/100g E 20171231 51523-113_31810c0e-b24c-43dc-817f-b00b89384bc9 51523-113 HUMAN OTC DRUG FACE IT Radiance Two Way Cake NB23 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 12.8784; 2; 1.4775 g/100g; g/100g; g/100g E 20171231 51523-114_faccf869-9a33-46fb-9234-1aee0a1137b7 51523-114 HUMAN OTC DRUG Lovely ME EX BB PACT SPF20 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD TITANIUM DIOXIDE; OCTINOXATE 13.852; 2 g/100g; g/100g E 20171231 51523-115_76b3f6f6-0a09-4755-a42e-ed6f2b99f0dd 51523-115 HUMAN OTC DRUG FACE IT 4D PERPECT TWO-WAY CAKE NB21 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20110909 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 13.96843; 3.5; 4.41 g/100g; g/100g; g/100g E 20171231 51523-116_29bd2103-7f07-4089-ac8d-c12a743b357c 51523-116 HUMAN OTC DRUG FACE IT 4D PERPECT TWO-WAY CAKE NB23 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20110909 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 13.96843; 3.5; 4.41 g/100g; g/100g; g/100g E 20171231 51523-117_48ec60f8-ccfe-4ec4-8424-f02c29cc876c 51523-117 HUMAN OTC DRUG FACE IT RADIANCE POWDER PACT SPF25 MOISTURE VEIL NB17 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110909 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 6.208; 1.96 mL/100mL; mL/100mL; mL/100mL E 20171231 51523-118_d3245728-b219-4ef7-b504-33d58b08abc3 51523-118 HUMAN OTC DRUG FACE IT RADIANCE FOUNDATION SPF20 NB21 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD TITANIUM DIOXIDE; OCTINOXATE 11.476; 4.5 mL/100mL; mL/100mL E 20171231 51523-119_15ee65da-cb07-4e63-b647-c17e18eaa350 51523-119 HUMAN OTC DRUG FACE IT RADIANCE FOUNDATION SPF20 NB23 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD TITANIUM DIOXIDE; OCTINOXATE 11.476; 4.5 mL/100mL; mL/100mL E 20171231 51523-120_c19787cc-cc28-4db4-a8ea-6686a9018d07 51523-120 HUMAN OTC DRUG FACE IT RADIANCE POWDER PACT SPF25 MOISTURE VEIL NB17 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 6.208; 1.96 g/100g; g/100g; g/100g E 20171231 51523-121_e385684f-c88e-48af-9827-1d886798b0ec 51523-121 HUMAN OTC DRUG FACE IT RADIANCE POWDER PACT SPF25 MOISTURE VEIL NB21 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 6.208; 1.96 g/100g; g/100g; g/100g E 20171231 51523-122_9492aeed-3634-4020-9f3c-4aafbd656c0b 51523-122 HUMAN OTC DRUG FACE IT RADIANCE POWDER PACT SPF25 MOISTURE VEIL NB23 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20110913 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 6.208; 1.96 g/100g; g/100g; g/100g E 20171231 51523-123_07d43d80-09bf-302b-e054-00144ff88e88 51523-123 HUMAN OTC DRUG NEO CLASSIC HOMME SPORTS 31700111 ensulizole, octinoxate and zinc oxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ENSULIZOLE; OCTINOXATE; ZINC OXIDE 1.7; 2.3; 4.1 g/45mL; g/45mL; g/45mL E 20171231 51523-168_1c0605bf-3c6c-336a-e054-00144ff8d46c 51523-168 HUMAN OTC DRUG NATURAL SUN ECO SEBUM CONTROL MOISTURE SUN SPF40 avobenzone, ensulizole, octinoxate and octisalate cream CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. AVOBENZONE; OCTISALATE; ENSULIZOLE; OCTINOXATE 1.2; 2; 1.8; 3.3 g/50mL; g/50mL; g/50mL; g/50mL E 20171231 51523-173_20e81a3c-b7b4-36b6-e054-00144ff8d46c 51523-173 HUMAN OTC DRUG NATURAL SUN ECO SUPER PERFECT SPF 50 avobenzone, octinoxate, octisalate, titanium dioxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; AVOBENZONE 3.6; 1.85; 2.35; 1.5 g/50mL; g/50mL; g/50mL; g/50mL E 20171231 51523-174_20e89367-56de-6ca9-e054-00144ff88e88 51523-174 HUMAN OTC DRUG NATURAL SUN ECO Mild Milk SPF40 avobenzone, ensulizole, octinoxate and octisalate lotion LOTION TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTINOXATE 2.76; 4.2; 4.8; 7.8 g/120mL; g/120mL; g/120mL; g/120mL E 20171231 51523-176_210f121f-506f-229c-e054-00144ff8d46c 51523-176 HUMAN OTC DRUG NATURAL SUN ECO Aqua Sunscreen Gel 40 SPF avobenzone, ensulizole, octinoxate and octisalate gel GEL TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. AVOBENZONE; ENSULIZOLE; OCTINOXATE; OCTISALATE 1.15; 1.75; 3.25; 2 g/50mL; g/50mL; g/50mL; g/50mL E 20171231 51523-178_2110c506-bf56-61eb-e054-00144ff8d46c 51523-178 HUMAN OTC DRUG NATURAL SUN ECO Calming Sensitive Sunscreen Cream SPF 40 zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE 7.85 g/50mL E 20171231 51523-187_0822fdb2-c661-12ec-e054-00144ff8d46c 51523-187 HUMAN OTC DRUG TheFaceShop Jelly Pact 34200187 octinoxate, titanium oxide and zinc oxide gel GEL TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .6; 1.71; .29 g/10g; g/10g; g/10g E 20171231 51523-188_0822d47f-298b-6499-e054-00144ff88e88 51523-188 HUMAN OTC DRUG TheFaceShop Jelly Pact 34200188 octinoxate, titanium dioxide and zinc oxide gel GEL TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .6; .17; .29 g/10g; g/10g; g/10g E 20171231 51523-193_2121c3b3-e67b-41fb-e054-00144ff8d46c 51523-193 HUMAN OTC DRUG NATURAL SUN ECO Oil Clear Sunscreen Cream 50 SPF ensulizole and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ENSULIZOLE; ZINC OXIDE 1.85; 6.45 g/50mL; g/50mL E 20171231 51523-194_2123e4cd-5c44-2748-e054-00144ff8d46c 51523-194 HUMAN OTC DRUG NATURAL SUN ECO Power Long-lasting Sunscreen Cream SPF50 octinoxate, octisalate and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; OCTISALATE; OCTINOXATE 6; 1; 3.6 g/50mL; g/50mL; g/50mL E 20171231 51523-257_1cbd9deb-5543-2bb1-e054-00144ff88e88 51523-257 HUMAN OTC DRUG GOLD COLLAGEN SPF 30 PA titanium dioxide and zinc oxide cream CREAM TOPICAL 20151231 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 4.6; .6 g/40mL; g/40mL E 20171231 51523-258_1cf890db-7823-5e08-e054-00144ff8d46c 51523-258 HUMAN OTC DRUG GOLD COLLAGEN Ampoule Foundation SPF30 titanium dioxide and zinc oxide cream POWDER TOPICAL 20151231 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 4.6; .6 g/40mL; g/40mL E 20171231 51523-259_1cf9945b-d956-5c11-e054-00144ff88e88 51523-259 HUMAN OTC DRUG GOLD COLLAGEN Ampoule Cover Cake SPF 50 octinoxate, octisalate, titanium dioxide and zinc oxide powder POWDER TOPICAL 20151231 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE .7; .2; 1.7; .5 g/11g; g/11g; g/11g; g/11g E 20171231 51523-260_1cfa5c23-e60e-30f3-e054-00144ff8d46c 51523-260 HUMAN OTC DRUG GOLD COLLAGEN Ampoule Cover Cake SPF50 N203 octinoxate, octisalate, titanium dioxide and zinc oxide cream POWDER TOPICAL 20151231 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE 1.7; .5; .7; .2 g/11g; g/11g; g/11g; g/11g E 20171231 51523-261_1fb58f25-efec-27b3-e054-00144ff8d46c 51523-261 HUMAN OTC DRUG GOLD COLLAGEN Ampoule Two-way Compact Foundation SPF30 octinoxate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; 1.23; 1.72 g/35g; g/35g; g/35g E 20171231 51523-262_1fb845bc-150b-5472-e054-00144ff88e88 51523-262 HUMAN OTC DRUG GOLD COLLAGEN N203 Natural Beige SPF30 octinoxate, titanium dioxide and zinc oxide powder POWDER TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .48; 1.33; .28 g/9.5g; g/9.5g; g/9.5g E 20171231 51523-285_07d4e9a6-8732-5c4f-e054-00144ff88e88 51523-285 HUMAN OTC DRUG FACE IT 32800285 octinoxate, titanium oxide and zinc oxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP NORTH AMERICA, INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.2; 2.28; 1.2 g/40mL; g/40mL; g/40mL E 20171231 51523-311_07d5e76a-da76-04b4-e054-00144ff88e88 51523-311 HUMAN OTC DRUG FACE IT POWER PERFECTION 32800311 octinoxate, titanium dioxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 2; 1.16; 4 g/40g; g/40g; g/40g E 20171231 51523-312_07d7d0ff-6506-147c-e054-00144ff8d46c 51523-312 HUMAN OTC DRUG FACE IT POWER PERFECTION 32800312 octinoxate and titanium dioxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 2; 4 g/40g; g/40g E 20171231 51523-317_0737ccd5-4cd5-610e-e054-00144ff88e88 51523-317 HUMAN OTC DRUG MYEONGHAN MIINDO HWANSAENGGO GOLD ESSENCE BB SPF 35 30100317 octinoxate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO. LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.35; 2.25; 3.51 g/45mL; g/45mL; g/45mL E 20171231 51523-361_1fb93523-eb50-24ee-e054-00144ff8d46c 51523-361 HUMAN OTC DRUG FACE TONE Controller 01 SPF30 octinoxate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; 1.23; 1.72 g/35g; g/35g; g/35g E 20171231 51523-362_1fbae84e-fffa-6d34-e054-00144ff8d46c 51523-362 HUMAN OTC DRUG AIR COTTON Makeup Base 02 SPF30 titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE 1.16; 2.04 g/40mL; g/40mL E 20171231 51523-362_210c6251-661c-5b6a-e054-00144ff88e88 51523-362 HUMAN OTC DRUG AIR COTTON MAKE UP BASE 01 MINT SPF 30 titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.04; 1.16 g/40mL; g/40mL E 20171231 51523-363_1fba85f3-b1ee-1d66-e054-00144ff88e88 51523-363 HUMAN OTC DRUG AIR COTTON Make-up Base 02 SPF30 titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.04; 1.16 g/40mL; g/40mL E 20171231 51523-365_20087532-7d49-5393-e054-00144ff88e88 51523-365 HUMAN OTC DRUG FACE TONE Controller SPF30 octinoxate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.75; 1.23; 1.72 g/35g; g/35g; g/35g E 20171231 51523-366_20e59e39-377b-2123-e054-00144ff8d46c 51523-366 HUMAN OTC DRUG BARE SKIN Nude Foundation V201 Apricot Beige SPF30 octinoxate, octisalate cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; OCTISALATE 2.1; .7 g/35g; g/35g E 20171231 51523-367_200a8ddb-debd-6d56-e054-00144ff8d46c 51523-367 HUMAN OTC DRUG BARE SKIN Nude Foundation Medium Beige SPF30 octinoxate and octisalate cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; OCTISALATE 2.1; .7 g/35g; g/35g E 20171231 51523-368_200b8838-126c-4cbb-e054-00144ff88e88 51523-368 HUMAN OTC DRUG BARE SKIN Nude Natural Beige SPF30 octinoxate and octisalate cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTISALATE; OCTINOXATE .7; 2.1 g/35g; g/35g E 20171231 51523-369_20448832-fdfc-0b2b-e054-00144ff88e88 51523-369 HUMAN OTC DRUG 15HR COVER LASTING V201 Apricot Beige SPF50 octinoxate, octisalate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTISALATE; OCTINOXATE 4.03; 1.72; 1.58; 2.45 g/35g; g/35g; g/35g; g/35g E 20171231 51523-370_2045df84-49c6-7261-e054-00144ff8d46c 51523-370 HUMAN OTC DRUG 15HR COVER LASTING M201 Medium Beige SPF50 octinoxate, octisalate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE; OCTISALATE 2.45; 4.03; 1.72; 1.58 g/35g; g/35g; g/35g; g/35g E 20171231 51523-371_2047cc56-89e3-4aa1-e054-00144ff8d46c 51523-371 HUMAN OTC DRUG 15HR COVER LASTING SPF50 octinoxate, octisalate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 2.45; 1.58; 4.03; 1.72 g/35g; g/35g; g/35g; g/35g E 20171231 51523-372_2047c86b-0edd-0c56-e054-00144ff88e88 51523-372 HUMAN OTC DRUG SKIN BRIGHTENING SPF50 octinoxate, titanium dioxide and zinc oxide powder POWDER TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .66; 1.28; .32 g/11g; g/11g; g/11g E 20171231 51523-373_209571ab-b239-11e0-e054-00144ff88e88 51523-373 HUMAN OTC DRUG SKIN BRIGHTENING SPF 50 PA octinoxate, titanium dioxide and zinc oxide powder POWDER TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .66; 1.28; .32 g/11g; g/11g; g/11g E 20171231 51523-374_20976d0a-c37a-2cc8-e054-00144ff8d46c 51523-374 HUMAN OTC DRUG SLIM FIT SPF 50 PA octinoxate, titanium dioxide and zinc oxide powder POWDER TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .66; 1.28; .32 g/11g; g/11g; g/11g E 20171231 51523-375_209884bc-04e2-6149-e054-00144ff8d46c 51523-375 HUMAN OTC DRUG SLIM FIT MOIST SPF 50 octinoxate, titanium dioxide and zinc oxide powder POWDER TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .66; 1.28; .32 g/11g; g/11g; g/11g E 20171231 51523-376_209884bc-04f7-6149-e054-00144ff8d46c 51523-376 HUMAN OTC DRUG MICRO RETOUCHING BLUR COMPACT SPF 50 octinoxate powder POWDER TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE .42 g/14g E 20171231 51523-377_20d0120d-e21b-25fd-e054-00144ff8d46c 51523-377 HUMAN OTC DRUG MICRO RETOUCHING N203 NATURAL BEIGE SPF50 octinoxate powder POWDER TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE .42 g/14g E 20171231 51523-378_07d78c56-a6d0-4d69-e054-00144ff8d46c 51523-378 HUMAN OTC DRUG FACE it 32800378 octinoxate, titanium oxide and zind oxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.65; 7.5; 2.95 g/50mL; g/50mL; g/50mL E 20171231 51523-379_07d7d0ff-6508-147c-e054-00144ff8d46c 51523-379 HUMAN OTC DRUG FACE IT BB (Natural Beige) 32800379 octinoxate, titanium oxide and zinc oxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2.95; 3.65; 7.35 g/50mL; g/50mL; g/50mL E 20171231 51523-393_20d10939-f2b9-4261-e054-00144ff88e88 51523-393 HUMAN OTC DRUG ULTIMATE CORRECTING BASE SPF50 octinoxate and octisalate cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTISALATE; OCTINOXATE 1.6; 2.68 g/40mL; g/40mL E 20171231 51523-406_20d1e07d-b7dd-6ebb-e054-00144ff8d46c 51523-406 HUMAN OTC DRUG FULL STAY CC 24HR octinoxate, octisalate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE; OCTINOXATE 2.14; .72; .78; 1.12 g/16g; g/16g; g/16g; g/16g E 20171231 51523-408_07d899a0-08ed-57b3-e054-00144ff88e88 51523-408 HUMAN OTC DRUG FACE IT POWER PERFECTION 32800408 octinoxate and titanium dioxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 1; 1.94 g/20mL; g/20mL E 20171231 51523-420_080ff250-52b4-0992-e054-00144ff88e88 51523-420 HUMAN OTC DRUG FACE IT AQUA TINTED 32800420 octinoxate CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE 2 g/40mL E 20171231 51523-421_08105130-2d5a-72c2-e054-00144ff8d46c 51523-421 HUMAN OTC DRUG FACE IT AQUA TINTED 32800421 octinoxate CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE 2 g/40mL E 20171231 51523-452_08150e7f-d6df-4da6-e054-00144ff8d46c 51523-452 HUMAN OTC DRUG PHYTOGENIC INFINTE EX 37100452 octinoxate, titanium dioxide powder POWDER TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .24; 1.68 g/12g; g/12g E 20171231 51523-453_08150e7f-d6e4-4da6-e054-00144ff8d46c 51523-453 HUMAN OTC DRUG PHYTOGENIC INFINTE EX 37100453 octinoxate and titanium dioxide powder POWDER TOPICAL 20141119 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .24; 1.68 g/12g; g/12g E 20171231 51523-455_08159cb4-dadf-4127-e054-00144ff88e88 51523-455 HUMAN OTC DRUG PHYTOGENIC INFINTE EX FOUNDATION 37100455 titanium dioxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE 3.26 g/35mL E 20171231 51523-456_20d2e1fd-586f-0477-e054-00144ff88e88 51523-456 HUMAN OTC DRUG FULL STAY 24HR SPF50 octinoxate, octisalate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 1.12; .72; 2.14; .78 g/16g; g/16g; g/16g; g/16g E 20171231 51523-457_0822d47f-2987-6499-e054-00144ff88e88 51523-457 HUMAN OTC DRUG PHYTOGENIC INFINTE 37100457 octinoxate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 2; 2; 2.4 g/40mL; g/40mL; g/40mL E 20171231 51523-466_20d3d316-c1ed-20f1-e054-00144ff88e88 51523-466 HUMAN OTC DRUG GOLD COLLAGEN FOUNDATION SPF30 octinoxate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .48; 1.33; .28 g/9.5g; g/9.5g; g/9.5g E 20171231 51523-468_20d35fa3-f96d-56d2-e054-00144ff8d46c 51523-468 HUMAN OTC DRUG FULL STAY V201 APRICOT BEIGE (REFILL) octinoxate, octisalate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE .78; 2.14; 1.12; .72 g/16g; g/16g; g/16g; g/16g E 20171231 51523-469_20e32e92-83bd-07fa-e054-00144ff8d46c 51523-469 HUMAN OTC DRUG FULL STAY 24HR V203 NATURAL BEIGE octinoxate, octisalate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 1.12; .72; 2.14; .78 g/16g; g/16g; g/16g; g/16g E 20171231 51523-472_0810780e-0fae-04da-e054-00144ff8d46c 51523-472 HUMAN OTC DRUG FACE IT HD PERFECT BB 32800472 octinoxate, titanium dioxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.8; 2.4; 1.2 g/40mL; g/40mL; g/40mL E 20171231 51523-473_0810780e-0fb2-04da-e054-00144ff8d46c 51523-473 HUMAN OTC DRUG FACE IT HD PERFECT BB 32800473 octinoxate, zinc oxide and titanium dioxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 2.8; 1.2; 2.4 g/40mL; g/40mL; g/40mL E 20171231 51523-474_20e41782-a15d-5bc7-e054-00144ff88e88 51523-474 HUMAN OTC DRUG BARE SKIN MINERAL COVER SPF 27 octinoxate and octisalate powder POWDER TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; OCTISALATE .57; .38 g/15g; g/15g E 20171231 51523-475_20e4b9dc-fb6f-1dcf-e054-00144ff8d46c 51523-475 HUMAN OTC DRUG BARE SKIN MINERAL COVER SPF27 octinoxate and octisalate powder POWDER TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; OCTISALATE .57; .38 g/15g; g/15g E 20171231 51523-657_0810780e-0fb6-04da-e054-00144ff8d46c 51523-657 HUMAN OTC DRUG FACE IT AURA COLOR CONTROL 32800657 octinoxate, titanium dioxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 2.3; .2; .8 g/20g; g/20g; g/20g E 20171231 51523-658_08112381-fc1d-1cf1-e054-00144ff8d46c 51523-658 HUMAN OTC DRUG FACE IT AURA COLOR CONTROL 32800658 octinoxate, titanium oxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .8; 2.3; .2 g/20g; g/20g; g/20g E 20171231 51523-659_080ff250-52b6-0992-e054-00144ff88e88 51523-659 HUMAN OTC DRUG FACE IT AURA COLOR CONTROL SPF30 (REFILL), 01 RADIANT BEIGE 32800659 octinoxate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE .2; .8; 2.3 g/20g; g/20g; g/20g E 20171231 51523-660_080ff250-52b8-0992-e054-00144ff88e88 51523-660 HUMAN OTC DRUG FACE IT AURA COLOR CONTROL 32800660 octinoxate, titanium dioxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE .2; .8; 2.3 g/20g; g/20g; g/20g E 20171231 51523-661_0811c661-f0d2-312f-e054-00144ff8d46c 51523-661 HUMAN OTC DRUG FACE IT SMART COLOR CONTROL 32800661 ensulizole, titanium dioxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; ENSULIZOLE; TITANIUM DIOXIDE 3.2; .8; 2.4 g/30mL; g/30mL; g/30mL E 20171231 51523-675_08121399-0956-4b48-e054-00144ff88e88 51523-675 HUMAN OTC DRUG FACE IT AURA COLOR CONTROL 32800675 octinoxate, titanium oxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 2.3; .2; .8 g/20g; g/20g; g/20g E 20171231 51523-676_08121399-0958-4b48-e054-00144ff88e88 51523-676 HUMAN OTC DRUG FACE IT AURA COLOR CONTROL 32800676 octinoxate, titanium dioxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .8; 2.3; .2 g/20g; g/20g; g/20g E 20171231 51523-677_0812c2b7-a915-3252-e054-00144ff88e88 51523-677 HUMAN OTC DRUG FACE IT SMART COLOR CONTROL 32800677 ensulizole, titanium dioxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ENSULIZOLE; TITANIUM DIOXIDE; ZINC OXIDE 1.1; 2.6; 4.2 g/40g; g/40g; g/40g E 20171231 51523-772_0fdc17fb-ad8b-24b6-e054-00144ff88e88 51523-772 HUMAN OTC DRUG FACE IT AQUA UV COLOR CONTROL 32800772 octinoxate, titanium dioxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .8; 2.3; .2 g/20g; g/20g; g/20g E 20171231 51523-773_08136a1f-5a36-01bb-e054-00144ff88e88 51523-773 HUMAN OTC DRUG FACE IT AQUA UV COLOR CONTROL 32800773 octinoxate, titanium dioxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE .2; .8; 2.3 g/20g; g/20g; g/20g E 20171231 51523-789_0813c3dd-9a1b-174b-e054-00144ff8d46c 51523-789 HUMAN OTC DRUG FACE IT AQUA UV COLOR CONTROL 32800789 octinoxate, titanium dioxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 2.3; .2; .8 g/20g; g/20g; g/20g E 20171231 51523-790_0fd8c46a-b0c9-52b3-e054-00144ff8d46c 51523-790 HUMAN OTC DRUG FACE IT AQUA UV COLOR CONTROL 32800790 octinoxate, titanium dioxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE .2; .8; 2.3 g/20g; g/20g; g/20g E 20171231 51523-842_0813c3dd-9a1e-174b-e054-00144ff8d46c 51523-842 HUMAN OTC DRUG FACE IT POWER PERFECTION BB 00 32800842 octinoxate, zinc oxide, titanium dioxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2; 3.9; 1.2 g/40g; g/40g; g/40g E 20171231 51523-843_0813c3dd-9a21-174b-e054-00144ff8d46c 51523-843 HUMAN OTC DRUG FACE IT POWER PERFECTION 32800843 octinoxate, titanium dioxide and zinc oxide CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 1.2; 2; 3.9 g/40g; g/40g; g/40g E 20171231 51523-851_0813c3dd-9a25-174b-e054-00144ff8d46c 51523-851 HUMAN OTC DRUG FACET IT PURE COLOR CONTROL 32800851 octinoxate, titanium dioxide and zinc oxide cream CREAM TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 THEFACESHOP CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.6; 4.1; .4 g/40mL; g/40mL; g/40mL E 20171231 51525-0112_de3be14c-f9e1-42c6-952d-98ef34ac6f7a 51525-0112 HUMAN PRESCRIPTION DRUG Hyoscyamine hyoscyamine sulfate TABLET ORAL 20160401 UNAPPROVED DRUG OTHER Wallace Pharmaceuticals Inc. HYOSCYAMINE SULFATE .125 mg/1 N 20181231 51525-0113_a30236af-4fc5-4dd5-bdf1-0b8fb34db3ac 51525-0113 HUMAN PRESCRIPTION DRUG Hyoscyamine SL hyoscyamine sulfate TABLET, ORALLY DISINTEGRATING ORAL 20160415 UNAPPROVED DRUG OTHER Wallace Pharmaceuticals Inc. HYOSCYAMINE SULFATE .125 mg/1 N 20181231 51525-0115_ab54bb20-d2c0-4471-afca-2329eaa06c2b 51525-0115 HUMAN PRESCRIPTION DRUG Hyoscyamine ER hyoscyamine sulfate TABLET ORAL 20160501 UNAPPROVED DRUG OTHER Wallace Pharmaceuticals Inc. HYOSCYAMINE SULFATE .375 mg/1 N 20181231 51525-0234_26612987-980b-48a0-917c-931a093e10f6 51525-0234 HUMAN PRESCRIPTION DRUG AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED NASAL 20150401 NDA AUTHORIZED GENERIC NDA022203 Wallace Pharmaceuticals Inc. AZELASTINE HYDROCHLORIDE 205.5 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 51525-0294_97c325ab-dbdf-41ce-b412-f6999a189528 51525-0294 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine Hydrochloride SPRAY, METERED NASAL 20100701 NDA AUTHORIZED GENERIC NDA020114 Wallace Pharmaceuticals Inc. AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 51525-0430_d6f39261-d969-431a-a372-0487262546ca 51525-0430 HUMAN PRESCRIPTION DRUG Felbamate felbamate TABLET ORAL 20111111 NDA AUTHORIZED GENERIC NDA020189 Wallace Pharmaceuticals Inc. FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51525-0431_d6f39261-d969-431a-a372-0487262546ca 51525-0431 HUMAN PRESCRIPTION DRUG Felbamate felbamate TABLET ORAL 20111111 NDA AUTHORIZED GENERIC NDA020189 Wallace Pharmaceuticals Inc. FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51525-0442_d6f39261-d969-431a-a372-0487262546ca 51525-0442 HUMAN PRESCRIPTION DRUG Felbamate felbamate SUSPENSION ORAL 20111123 NDA AUTHORIZED GENERIC NDA020189 Wallace Pharmaceuticals Inc. FELBAMATE 600 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51525-0470_2e4bb274-cd0f-4fb2-a97b-30f35dd2ce56 51525-0470 HUMAN PRESCRIPTION DRUG Cromolyn Sodium cromolyn SOLUTION ORAL 20151020 NDA NDA020479 Wallace Pharmaceuticals Inc. CROMOLYN SODIUM 20 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 51525-470_f4eb8dee-b5db-40f6-8857-19b4ca7f6d9c 51525-470 HUMAN PRESCRIPTION DRUG Cromolyn Sodium cromolyn sodium CONCENTRATE ORAL 20150615 20180531 NDA NDA020479 Wallace Pharmaceuticals Inc. CROMOLYN SODIUM 20 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] E 20171231 51525-5901_251f0084-e7ae-11e1-aff1-0800200c9a66 51525-5901 HUMAN PRESCRIPTION DRUG Carisoprodol carisoprodol TABLET ORAL 20100701 NDA AUTHORIZED GENERIC NDA011792 Wallace Pharmaceuticals Inc. CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 51525-6831_486598b0-0358-11e3-8ffd-0800200c9a66 51525-6831 HUMAN PRESCRIPTION DRUG TriLyte with Flavor Packs Polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride POWDER, FOR SOLUTION NASOGASTRIC; ORAL 20130923 ANDA ANDA076491 Wallace Pharmaceuticals Inc. POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE 420; 11.2; 5.72; 1.48 g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 51525-7815_edbf877a-80ef-412b-9d77-cc67d2850fb3 51525-7815 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS INTRAOCULAR 20101001 NDA AUTHORIZED GENERIC NDA021127 Wallace Pharmaceuticals Inc. AZELASTINE HYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 51531-0288_b1359c9f-4d4f-4208-bac0-aceab9a09291 51531-0288 HUMAN OTC DRUG MKMen Advanced Facial Hydrator Sunscreen SPF 30 avobenzone, homosalate, octisalate, octocrylene, oxybenzone LOTION TOPICAL 20130516 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-0332_b637bf3f-b40e-499e-968d-4260517cef59 51531-0332 HUMAN OTC DRUG MKMen Moisturizer Sunscreen Broad Spectrum SPF 25 avobenzone, homosalate, octinoxate, octisalate, oxybenzone LOTION TOPICAL 20070616 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 10; 7.5; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-0349_d7f7c12c-0bf0-4753-8c79-38e146ba152b 51531-0349 HUMAN OTC DRUG Mary Kay Suncare Sunscreen SPF 30 avobenzone, homosalate, octinoxate, octisalate, oxybenzone LOTION TOPICAL 20070316 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 10; 7.5; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-0850_acca6d11-87a8-4963-aa33-2fc9a99c3869 51531-0850 HUMAN OTC DRUG Mary Kay Foundation Primer avobenzone, homosalate, octisalate, octocrylene GEL TOPICAL 20120301 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 9; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-1349_81a35520-79e6-4621-969a-6719f1580ac9 51531-1349 HUMAN OTC DRUG Clear Proof Clarifying Cleansing Gel Acne Medication Salicylic Acid GEL TOPICAL 20130815 OTC MONOGRAPH FINAL part333D Mary Kay Inc. SALICYLIC ACID 2 g/100g N 20191231 51531-2326_3abec8b9-b0ed-4e97-904c-4853004f73ec 51531-2326 HUMAN OTC DRUG Mary Kay TimeWise Day Solution Sunscreen SPF 25 octinoxate, octisalate, zinc oxide, oxybenzone, LOTION TOPICAL 20051216 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 3.88; 3 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-2656_65e846f8-c738-4259-8297-c81e6739f223 51531-2656 HUMAN OTC DRUG Mary Kay TimeWise Day Solution SPF 35 avobenzone, homosalate, octisalate, octocrylene, oxybenzone SOLUTION TOPICAL 20140516 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-2822_67912b9c-cdf9-4fda-a845-7a1de2fa25a4 51531-2822 HUMAN OTC DRUG Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Light homosalate, octinoxate, oxybenzone CREAM TOPICAL 20140216 OTC MONOGRAPH FINAL part352 Mary Kay Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE 5; 6.5; 1.2 g/100mL; g/100mL; g/100mL N 20191231 51531-2823_620cda6a-5f7c-42a3-98dd-ed0dab7681e5 51531-2823 HUMAN OTC DRUG Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to Medium homosalate, octinoxate, oxybenzone CREAM TOPICAL 20140216 OTC MONOGRAPH FINAL part352 Mary Kay Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE 5; 6.5; 1.2 g/100mL; g/100mL; g/100mL N 20191231 51531-2824_e79631f7-1196-4f54-830b-2590d6c740f4 51531-2824 HUMAN OTC DRUG Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep homosalate, octinoxate, oxybenzone CREAM TOPICAL 20140216 OTC MONOGRAPH FINAL part352 Mary Kay Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE 5; 6.5; 1.2 g/100mL; g/100mL; g/100mL N 20191231 51531-2825_052ce1fc-3523-404f-b3f3-5d216ca2311d 51531-2825 HUMAN OTC DRUG Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Deep homosalate, octinoxate, oxybenzone CREAM TOPICAL 20140216 OTC MONOGRAPH FINAL part352 Mary Kay Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE 5; 6.5; 1.2 g/100mL; g/100mL; g/100mL N 20191231 51531-2963_7548c20e-f70c-4e87-acf4-5489fe8d28bd 51531-2963 HUMAN OTC DRUG Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30 avobenzone, homosalate, octisalate, octocrylene, oxybenzone CREAM TOPICAL 20160516 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 51531-2965_e36b09e4-6525-4e38-b173-7831b40427b3 51531-2965 HUMAN OTC DRUG Mary Kay TimeWise Repair Volu-Firm Sampler Set Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone KIT 20160516 OTC MONOGRAPH FINAL part352 Mary Kay Inc. N 20181231 51531-3070_5fabb49d-39ab-40da-9be5-158ed02b7000 51531-3070 HUMAN OTC DRUG Mary Kay TimeWise Repair Volu-Firm Set Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone KIT 20160516 OTC MONOGRAPH FINAL part352 Mary Kay Inc. N 20181231 51531-3276_0d2dd0f5-a87e-42d2-9300-20948c6287e0 51531-3276 HUMAN OTC DRUG Mary Kay Suncare Sunscreen Broad Spectrum SPF 50 avobenzone, homosalate, octisalate, octocrylene, oxybenzone LOTION TOPICAL 20140316 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 4.5; 5.5; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-4102_829f9d50-d3e9-4958-b06c-1bcf32e7869f 51531-4102 HUMAN OTC DRUG Mary Kay TimeWise Age Fighting Moisturizer SPF 30 avobenzone, homosalate, octisalate, octocrylene, oxybenzone LOTION TOPICAL 20120316 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-4160_c4e3b9c8-b214-4f93-8c11-3cafbb5632e9 51531-4160 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Peach octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20110616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g N 20191231 51531-4161_fcdae00b-e96c-40ec-9e66-5dea9ca6681c 51531-4161 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Peony octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20110616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g N 20191231 51531-4162_4214370d-551a-4ffb-8d77-f4161bb64c42 51531-4162 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Berry octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20110616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g N 20191231 51531-4163_13ef0b02-6846-4f50-8034-8bc353c0d71f 51531-4163 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Cherry octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20110616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g N 20191231 51531-4189_6769f6f0-8310-440c-aceb-e11f97d7790d 51531-4189 HUMAN OTC DRUG Foundation Primer SPF 15 Titanium Dioxide , Zinc Oxide , Octinoxate CREAM TOPICAL 20091111 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE .222; 2.73; .7 g/14g; g/14g; g/14g N 20191231 51531-4250_dff78c4a-d1d9-440b-86f7-d12404201806 51531-4250 HUMAN OTC DRUG Mary Kay Suncare Sunscreen Broad Spectrum SPF 50 avobenzone, homosalate, octisalate, octocrylene, oxybenzone LOTION TOPICAL 20120316 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-4325_cd7e9252-678d-4951-b1bd-7567bae77a3d 51531-4325 HUMAN OTC DRUG Mary Kay TimeWise Body Hand and Decolette Cream SPF 15 avobenzone, octisalate, octocrylene, oxybenzone CREAM TOPICAL 20100315 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 2.2; 3 g/100g; g/100g; g/100g; g/100g N 20191231 51531-4328_d62e4b7a-4532-4f7c-a314-a1ff3deb36e3 51531-4328 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Ivory 1 (Drug Facts) octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 2.43; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-4329_4065fcad-96ab-4c9f-8824-639bdb6b9258 51531-4329 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Ivory 2 (Drug Facts) octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 2.43; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-4330_2b9a7e40-59be-47ec-85d2-a1cb01b99301 51531-4330 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Beige 1 (Drug Facts) octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 2.43; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-4331_40b5755b-5f5b-49b3-a9be-70d30f74aaf1 51531-4331 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Beige 2 (Drug Facts) octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 2.43; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-4332_b16ee921-fde2-49ce-900b-508d2b3a43ef 51531-4332 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Bronze 1 (Drug Facts) octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 2.43; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-4333_0095e08f-dc9a-48a9-bd8f-0eb63f878d8d 51531-4333 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Bronze 2 (Drug Facts) octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 2.43; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-4399_42b92073-be1c-4abd-9966-7d3026aec5c6 51531-4399 HUMAN OTC DRUG Mary Kay TimeWise Repair VoluFirm Day Cream SPF 30 avobenzone, homosalate, octisalate, octocrylene, oxybenzone CREAM TOPICAL 20120716 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20191231 51531-5201_cef459ee-6726-4236-85f5-092ecbd17459 51531-5201 HUMAN OTC DRUG Mary Kay TimeWise Repair Volu-Firm The Go Set Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone KIT 20171116 OTC MONOGRAPH FINAL part352 Mary Kay Inc. N 20191231 51531-5393_ad796220-b224-42a2-aff9-7becbe716662 51531-5393 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Rose octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g N 20191231 51531-5394_7c1ecfae-5d10-4a52-b57b-17e493bc4bb6 51531-5394 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Mango octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g N 20191231 51531-5395_ff531a89-da5d-454f-8728-440ee26c99d0 51531-5395 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Apricot octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g N 20191231 51531-5396_7aec7349-0891-40d3-a7c4-874634b39bd3 51531-5396 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Poppy octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g N 20191231 51531-5397_38f03867-b1f5-4cd6-a840-7521f79ac8c9 51531-5397 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Fig octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g N 20191231 51531-5748_aff46d4c-5685-436e-895f-25bff61721b0 51531-5748 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Blush octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g N 20191231 51531-5749_fb7a89de-d382-4ec8-b570-8e5897d86b90 51531-5749 HUMAN OTC DRUG Mary Kay Tinted Lip Balm Sunscreen SPF 15 Natural octinoxate, octocrylene, oxybenzone, zinc oxide LIPSTICK TOPICAL 20090616 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 5; 3; 5; 7.99 g/100g; g/100g; g/100g; g/100g N 20191231 51531-6620_ba152543-0d0e-4287-b09c-57771b949a43 51531-6620 HUMAN OTC DRUG Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Deep homosalate, octinoxate, oxybenzone CREAM TOPICAL 20160216 OTC MONOGRAPH FINAL part352 Mary Kay Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE 5; 6.5; 1.2 g/100mL; g/100mL; g/100mL N 20191231 51531-6743_e05904f2-ce35-4223-a06a-98a6a9876753 51531-6743 HUMAN OTC DRUG Clear Proof Blemish Control Toner Acne Medication Salicylic Acid LIQUID TOPICAL 20130815 OTC MONOGRAPH FINAL part333D Mary Kay Inc. SALICYLIC ACID 2 g/100mL N 20191231 51531-7472_657f5afa-b850-4adc-9d3c-75a3a438dc8b 51531-7472 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Ivory 1 octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20060816 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 2.4; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-7481_d9bedf08-74ad-4dc8-8418-f952bfa653e7 51531-7481 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Ivory 2 octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20060816 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 2.4; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-7487_6def08dd-a088-4f17-9322-72c17c35f9f0 51531-7487 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Beige 1 octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20060816 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 2.4; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-7493_5937cfb0-bc0e-4d59-82aa-0fee8f846051 51531-7493 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Beige 2 octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20060816 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 2.4; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-7497_0e42411c-efa4-44af-bdbe-bb0a85da6508 51531-7497 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Bronze 1 octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20060816 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 2.4; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-7502_e07d035a-1686-4413-8c42-a8e5f224a90a 51531-7502 HUMAN OTC DRUG Mary Kay Tinted Moisturizer Sunscreen SPF 20 Bronze 2 octinoxate, octisalate, zinc oxide, oxybenzone, CREAM TOPICAL 20060816 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE 7.5; 5; 2.4; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-8360_6c873604-a9cc-4985-8612-cbb09b6812da 51531-8360 HUMAN OTC DRUG Mary Kay TimeWise Day Solution SPF 35 avobenzone, homosalate, octisalate, octocrylene, oxybenzone SOLUTION TOPICAL 20120301 OTC MONOGRAPH FINAL part352 Mary Kay Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20191231 51531-8363_ab14546e-9ffa-415d-9899-f2d60184b7f7 51531-8363 HUMAN OTC DRUG Timewise Day Solution sunscreen SPF 35 Homosalate,Octisalate,Oxybenzone,Octocrylene,Avobenzone CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OXYBENZONE; AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 1.16; .58; 1.45; 2.9; .58 mL/29mL; mL/29mL; mL/29mL; mL/29mL; mL/29mL N 20191231 51531-8365_1102570e-9bbc-4ffd-8f70-d4d19d02f0a7 51531-8365 HUMAN OTC DRUG Timewise Day Solution sunscreen SPF 35 14ml Homosalate,Octisalate,Oxybenzone,Octocrylene,Avobenzone CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Mary Kay Inc. OXYBENZONE; AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE .56; .28; .7; 1.4; .28 mL/14mL; mL/14mL; mL/14mL; mL/14mL; mL/14mL N 20191231 51531-8968_f56a4d94-d80e-46c0-a36b-0bb81cbf4795 51531-8968 HUMAN OTC DRUG Clear Proof Acne System The Go Set Benzoyl Peroxide and Salicylic Acid KIT 20130815 OTC MONOGRAPH FINAL part333D Mary Kay Inc. N 20181231 51531-8977_6ae38e34-064b-48c3-8090-abc7e0747e24 51531-8977 HUMAN OTC DRUG Clear Proof Acne System Benzoyl Peroxide and Salicylic Acid KIT 20130815 OTC MONOGRAPH FINAL part333D Mary Kay Inc. N 20181231 51531-9059_881835ed-b9b6-4650-936f-381386e3cf3e 51531-9059 HUMAN OTC DRUG Clear Proof Pore Purifying Serum Acne Medication Salicylic Acid SOLUTION TOPICAL 20130815 OTC MONOGRAPH FINAL part333D Mary Kay Inc. SALICYLIC ACID 2 g/100g N 20191231 51531-9071_3b881c84-ab16-49bb-b9f0-a4f58dc1de53 51531-9071 HUMAN OTC DRUG Clear Proof Acne Treatment Acne Medication Benzoyl Peroxide GEL TOPICAL 20120615 OTC MONOGRAPH FINAL part333D Mary Kay Inc. BENZOYL PEROXIDE 5 g/100g N 20181231 51531-9480_49358ccd-fda4-403e-8ce9-009257ad6ba9 51531-9480 HUMAN OTC DRUG Lip Protector Sunscreen SPF15 Octinoxate,Zinc Oxide,Oxybenzone LIPSTICK TOPICAL 20070301 OTC MONOGRAPH NOT FINAL part352 Mary Kay INC. OCTINOXATE; OXYBENZONE; ZINC OXIDE .338; .135; .152 g/4.5g; g/4.5g; g/4.5g N 20191231 51531-9500_e3c41da1-d887-41c2-a6dd-ca4edf92e4df 51531-9500 HUMAN OTC DRUG New Lip Protector Sunscreen SPF15 Octinoxate,Avobenzone,Octocrylene LIPSTICK TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Mary Kay INC. OCTINOXATE; AVOBENZONE; OCTOCRYLENE .09; .1125; .27 g/4.5g; g/4.5g; g/4.5g N 20191231 51532-0107_16381a80-13b7-4929-a4cb-f1a7148f45cd 51532-0107 HUMAN OTC DRUG Chloresin Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine TABLET ORAL 20161025 OTC MONOGRAPH FINAL part341 Affasco Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 1/1; 1/1; 1/1; 1/1 N 20181231 51532-0140_8e9a098b-0113-45db-8a49-814ebdb4f303 51532-0140 HUMAN OTC DRUG Fedrin Acetaminophen, Phenylephrine TABLET ORAL 20161025 OTC MONOGRAPH FINAL part341 Afassco Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 1/1; 1/1 N 20181231 51532-0232_2558d032-0ac2-4d9b-a8cb-5a7f9b767ff3 51532-0232 HUMAN OTC DRUG Aspirin 325mg Aspirin TABLET ORAL 20150331 OTC MONOGRAPH NOT FINAL part343 Afassco Inc. ASPIRIN 325 mg/1 N 20181231 51532-0242_386b5f2b-fd2b-4919-8b95-7836bd26097b 51532-0242 HUMAN OTC DRUG Pain Free Acetaminophen, Aspirin, Caffeine, Salicylamide TABLET ORAL 20161025 OTC MONOGRAPH NOT FINAL part343 Afassco Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE; SALICYLAMIDE 110; 162; 32.4; 152 1/1; 1/1; 1/1; 1/1 N 20181231 51532-0303_b39991bc-f98e-4543-9fa8-9ff3e2b63970 51532-0303 HUMAN OTC DRUG Magnacal CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20150407 OTC MONOGRAPH FINAL part331 Afassco Inc. CALCIUM CARBONATE 420 1/1 N 20181231 51532-0315_b8333d3d-0807-42ea-bf00-43629affac5e 51532-0315 HUMAN OTC DRUG SOOTHE-A-STING ETHYL ALCOHOL, BENZOCAINE LIQUID TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part348 Afassco Inc ALCOHOL; BENZOCAINE .4; .02 g/mL; g/mL N 20181231 51532-0560_972b4964-83ac-4e97-a70a-7df4c99f72d9 51532-0560 HUMAN OTC DRUG Pain Free Plus Acetaminophen, Aspirin, Caffeine TABLET ORAL 20161025 OTC MONOGRAPH NOT FINAL part343 Afassco Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 1/1; 1/1; 1/1 N 20181231 51532-0700_6d7e1de6-5bd9-4d60-abd3-f20281c28af6 51532-0700 HUMAN OTC DRUG Femadrine Acetaminophen, Pamabrom TABLET ORAL 20161025 OTC MONOGRAPH NOT FINAL part343 Afassco Inc. ACETAMINOPHEN; PAMABROM 325; 25 1/1; 1/1 N 20181231 51532-4616_98e13f2e-28ba-4fa1-a812-43d9c85b6551 51532-4616 HUMAN OTC DRUG CUT CLEANER BENZALKONIUM CHLORIDE, BENZOCAINE SWAB TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part348 Afassco Inc BENZALKONIUM CHLORIDE; BENZOCAINE .45; 22.5 mg/.45g; mg/.45g N 20181231 51532-5104_4787f361-a72a-4c92-a2ed-1200205aa81f 51532-5104 HUMAN OTC DRUG MEDI-WIPES ETHYL ALCOHOL, CHLOROXYLENOL SWAB TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part333E Afassco Inc ALCOHOL; CHLOROXYLENOL .6; 7.5 g/1.5g; g/1.5g N 20181231 51532-5300_1ec3eb2f-c959-4932-9d6a-51c9e718678e 51532-5300 HUMAN OTC DRUG Antiseptic benzalkonium chloride, benzocaine SPRAY TOPICAL 20120709 OTC MONOGRAPH NOT FINAL part333A Afassco Inc. BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/mL; mg/mL N 20181231 51532-5301_4af11d65-d82b-4275-9eb9-8f08869409af 51532-5301 HUMAN OTC DRUG Antiseptic benzalkonium chloride, benzocaine LIQUID TOPICAL 20120731 OTC MONOGRAPH NOT FINAL part333A Afassco Inc. BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/mL; mg/mL N 20181231 51532-5400_99b4701d-95e0-43ae-9720-98e79a68cab8 51532-5400 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20120216 OTC MONOGRAPH NOT FINAL part333A Afassco Inc. HYDROGEN PEROXIDE 30 mL/L N 20181231 51532-5500_48c44dc8-210d-4b2b-94e5-42d444f219fa 51532-5500 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120216 OTC MONOGRAPH NOT FINAL part333A Afassco Inc. ISOPROPYL ALCOHOL 700 mL/L N 20181231 51532-6101_aada473d-23f5-4eca-8611-d1d0bf745e7a 51532-6101 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride LIQUID TOPICAL 20120216 OTC MONOGRAPH NOT FINAL part348 Afassco Inc. LIDOCAINE HYDROCHLORIDE 200 mL/L N 20181231 51532-6103_bffdc3d0-b2e6-41a4-aaa8-4f7221095390 51532-6103 HUMAN OTC DRUG Sunfree Sunscreen Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 Afassco HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 6; 7.5; 5; 5 mg/g; mg/g; mg/g; mg/g N 20181231 51532-6708_e9e59c6b-f813-4b69-9075-45ae561294ee 51532-6708 HUMAN OTC DRUG INDUSTRIAL NEUTRAL-EYES WATER LIQUID OPHTHALMIC 20150701 OTC MONOGRAPH FINAL part349 Afassco Inc WATER 232.6 mg/236mL E 20171231 51545-110_604e5e57-3b7f-3da0-e053-2991aa0a55f8 51545-110 HUMAN OTC DRUG Porcelana Day Skin Lightening Hydroquinone and Octinoxate CREAM TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part358A Ultimark Products LLC HYDROQUINONE; OCTINOXATE .02; .025 g/g; g/g N 20181231 51545-120_604ebd3e-e450-510f-e053-2a91aa0ae22b 51545-120 HUMAN OTC DRUG Porcelana Night Skin Lightening Hydroquinone CREAM TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part358A Ultimark Products LLC HYDROQUINONE .02 g/g N 20181231 51545-210_603ae742-efd8-7663-e053-2991aa0ae051 51545-210 HUMAN OTC DRUG Denorex Extra Strength Salicylic Acid SHAMPOO TOPICAL 20091101 20181130 OTC MONOGRAPH FINAL part358H Ultimark Products LLC SALICYLIC ACID .03 g/mL N 20181231 51545-220_603b2673-494e-6e50-e053-2991aa0ac955 51545-220 HUMAN OTC DRUG Denorex Therapeutic Coal Tar and Menthol SHAMPOO TOPICAL 20091101 20180731 OTC MONOGRAPH FINAL part358H Ultimark Products LLC COAL TAR; MENTHOL .018; .015 g/mL; g/mL N 20181231 51545-250_603b57f3-50d8-be99-e053-2991aa0a5984 51545-250 HUMAN OTC DRUG Zincon Medicated Dandruff Pyrithione zinc SHAMPOO TOPICAL 20101101 20181130 OTC MONOGRAPH FINAL part358H Ultimark Products LLC PYRITHIONE ZINC .01 g/mL N 20181231 51561-001_64be4a7c-4797-49c7-bb84-fda300554cf6 51561-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20100301 UNAPPROVED MEDICAL GAS Island Respiratory Care, Inc OXYGEN 99 L/100L E 20171231 51564-101_f9b3b22d-44aa-4670-9c79-58a420675c5b 51564-101 HUMAN PRESCRIPTION DRUG VIRAZOLE RIBAVIRIN LIQUID INTRAVENOUS 20171206 UNAPPROVED DRUG OTHER Legacy Pharmaceuticals Switzerland GmbH RIBAVIRIN .1 g/mL Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 51567-001_f52effb4-3a2e-4287-b3ea-f1a816c1e892 51567-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20090101 UNAPPROVED MEDICAL GAS Oxygenworks OXYGEN 99 L/100L E 20171231 51596-004_b34d453b-5109-4fbe-b4d6-78f8b0dde776 51596-004 HUMAN OTC DRUG Upset Stomach Relief to Go Bismuth subsalicylate POWDER ORAL 20110901 OTC MONOGRAPH FINAL part335 Breakthrough Products Inc. BISMUTH SUBSALICYLATE 525 mg/1 E 20171231 51596-005_f967a69f-b048-4776-a0b9-11562d5a1c29 51596-005 HUMAN OTC DRUG Heartburn Relief to Go Calcium carbonate POWDER ORAL 20110901 OTC MONOGRAPH FINAL part331 Breakthrough Products Inc. CALCIUM CARBONATE 1000 mg/1 E 20171231 51596-006_3ad5094c-8ce5-4f05-af55-f0448f06cdfb 51596-006 HUMAN OTC DRUG Critical Care Aspirin to Go aspirin POWDER ORAL 20121001 OTC MONOGRAPH NOT FINAL part343 Breakthrough Products Inc. ASPIRIN 325 mg/1 E 20171231 51596-007_54d1f19d-5b36-4fec-84cf-25651a1a4f2c 51596-007 HUMAN OTC DRUG Headache Relief to Go aspirin and caffeine POWDER ORAL 20121001 OTC MONOGRAPH NOT FINAL part343 Breakthrough Products Inc. ASPIRIN; CAFFEINE 325; 30 mg/1; mg/1 E 20171231 51596-008_11bf8091-bb9d-48a5-ba03-a6886a0da329 51596-008 HUMAN OTC DRUG Ache and Pain Relief to Go aspirin and caffeine POWDER ORAL 20121001 OTC MONOGRAPH NOT FINAL part343 Breakthrough Products Inc. ASPIRIN; CAFFEINE 650; 60 mg/1; mg/1 E 20171231 51596-009_8ffb4f55-f838-4a59-8894-158acb12af74 51596-009 HUMAN OTC DRUG Allergy Attack Relief to Go DIPHENHYDRAMINE HYDROCHLORIDE POWDER ORAL 20121001 OTC MONOGRAPH FINAL part341 Breakthrough Products Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 51596-010_bf6a7b84-37ef-4a46-9c3f-cf15b87648b6 51596-010 HUMAN OTC DRUG Headache Relief To Go acetaminophen and caffeine POWDER ORAL 20140715 OTC MONOGRAPH NOT FINAL part343 Breakthrough Products Inc. ACETAMINOPHEN; CAFFEINE 650; 50 mg/1; mg/1 E 20171231 51596-011_221e5ed2-fdc1-4d51-9cdd-aa9b5ee59429 51596-011 HUMAN OTC DRUG Headache Relief To Go acetaminophen and caffeine POWDER ORAL 20140715 OTC MONOGRAPH NOT FINAL part343 Breakthrough Products Inc. ACETAMINOPHEN; CAFFEINE 650; 50 mg/1; mg/1 E 20171231 51607-001_ca39812a-843c-4be4-b3d6-c22be7ade293 51607-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19380101 NDA NDA205865 Star Weld OXYGEN 990 mL/L N 20181231 51609-0001_0e076375-c4f6-4416-990a-49f919f73818 51609-0001 HUMAN OTC DRUG rHGH Complex Arnica Montana, Deer Antler Velvet, Hepar Bovinum, HGH, IGF, Pituitary Bovinum, Thuja Occidentalis LIQUID ORAL 20120927 UNAPPROVED HOMEOPATHIC Fitness Systems Mfg Corp ARNICA MONTANA; CERVUS ELAPHUS VELVET; BEEF LIVER; SOMATROPIN; MECASERMIN; BOS TAURUS PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG 6; 8; 6; 24; 6; 5; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 51613-001_424c07a3-10af-489c-8c5e-e4ad5f4dc628 51613-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS Pooch Welding Supply Company, Inc. OXYGEN 992 mL/L E 20171231 51613-002_cf37de98-8ed6-48d5-81a8-50a5fd861623 51613-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS Pooch Welding Supply Company, Inc. NITROGEN 990 mL/L E 20171231 51614-0001_91eef8eb-b9b1-4b7c-bef1-36f997e77779 51614-0001 HUMAN OTC DRUG Ultracare For Hands BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120622 OTC MONOGRAPH NOT FINAL part333A Coltene Whaledent Inc BENZALKONIUM CHLORIDE 1 mg/mL E 20171231 51615-001_79f3c28a-8e63-4f31-8fa3-f570ee4af760 51615-001 HUMAN OTC DRUG Muscle and Joint HRX Pain Relieving Camphor OIL TOPICAL 20100701 OTC MONOGRAPH FINAL part348 Eximus Connections d/b/a Herbal Destination CAMPHOR (NATURAL) 3 mL/100mL E 20171231 51619-300_7ffb6cdb-e244-8b40-70db-f9d43dd794c1 51619-300 HUMAN OTC DRUG PEPSOM SPORTS WINTERGREEN magnesium sulfate FOR SOLUTION TOPICAL 20080905 UNAPPROVED DRUG OTHER The Pepsom Group, Inc. MAGNESIUM SULFATE, UNSPECIFIED 1 kg/kg E 20171231 51619-400_636a9d7b-1e6d-26a7-308e-02b04e90f703 51619-400 HUMAN OTC DRUG PEPSOM SPORTS SPEARMINT magnesium sulfate FOR SOLUTION TOPICAL 20080905 UNAPPROVED DRUG OTHER The Pepsom Group, Inc. MAGNESIUM SULFATE, UNSPECIFIED 1 kg/kg E 20171231 51619-500_c25d03f1-69ed-ead7-ba1e-1c60b4d4442a 51619-500 HUMAN OTC DRUG PEPSOM SALT PEPPERMINT magnesium sulfate FOR SOLUTION TOPICAL 20070521 OTC MONOGRAPH NOT FINAL part334 The Pepsom Group, Inc. MAGNESIUM SULFATE, UNSPECIFIED 1 kg/kg E 20171231 51619-600_d27f7b36-d902-d715-3120-1832bcdac4a4 51619-600 HUMAN OTC DRUG PEPSOM FLYING P EPSOM SALT magnesium sulfate FOR SOLUTION TOPICAL 20091109 OTC MONOGRAPH NOT FINAL part334 The Pepsom Group, Inc. MAGNESIUM SULFATE, UNSPECIFIED 1 kg/kg E 20171231 51621-011_c16babda-03b6-49f3-bbf6-51aef2ac9181 51621-011 HUMAN OTC DRUG Gowoonsesang Multi Protection SPF30 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.49; 1.84 mL/60mL; mL/60mL E 20171231 51621-012_ccc18d3b-543c-4ce7-bd81-b232bbe182a1 51621-012 HUMAN OTC DRUG Gowoonsesang Medi UV Block Suncream SPF50 ZINC OXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE 2.88; 1.49 mL/60mL; mL/60mL E 20171231 51621-013_5e18a04a-04f4-4f0c-bee6-81e3f057b28d 51621-013 HUMAN OTC DRUG Gowoonsesang Hydra Intensive Blemish Balm SPF30 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 3; .3 mL/60mL; mL/60mL E 20171231 51621-014_c1c76695-3468-49cb-af89-8d2539232904 51621-014 HUMAN OTC DRUG Gowoonsesang Brightening Balm SPF30 TITANIUM DIOXIDE CREAM CUTANEOUS 20090601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 4.75; 1.18 mL/60mL; mL/60mL E 20171231 51621-030_fae17c7c-de3a-4f6c-aafb-c7805e201d9f 51621-030 HUMAN OTC DRUG BEYOND YOUNG BLING BLING SPF35 Titanium Dioxide CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 3.6; .4 mL/45mL; mL/45mL E 20171231 51621-031_fce1446c-ba51-4929-a0cf-bd4cd58685a3 51621-031 HUMAN OTC DRUG DR.G PRIMER BB PROTECTOR SPF38 TITANIUM DIOXIDE CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 4.5; .45 mL/45mL; mL/45mL E 20171231 51621-032_1b2f2608-d6aa-4d05-af8a-a24d7a1b76c9 51621-032 HUMAN OTC DRUG ACTIFIRM RECOVERY TONER GOWOONSESANG EXPERT GLYCERIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. GLYCERIN 28 mL/140mL E 20171231 51621-033_4e6c98f7-8484-4ee7-bb15-cf6fcfaa0940 51621-033 HUMAN OTC DRUG ACTIFIRM RECOVERY EMULSION GOWOONSESANG EXPERT DIMETHICONE CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. DIMETHICONE 2 mL/100mL E 20171231 51621-034_a6c48190-b8ed-454e-9e98-3639135238cb 51621-034 HUMAN OTC DRUG ACTIFIRM RECOVERY SERUM GOWOONSESANG EXPERT DIMETHICONE CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. DIMETHICONE 1.2 mL/30mL E 20171231 51621-035_1949fdea-f68a-42a9-bfdd-03012212aa6c 51621-035 HUMAN OTC DRUG ACTIFIRM RECOVERY GOWOONSESANG EXPERT DIMETHICONE CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. DIMETHICONE .5 mL/50mL E 20171231 51621-036_0af88431-f722-489f-93b9-f035c5519c44 51621-036 HUMAN OTC DRUG ACTIFIRM RECOVERY EYE GOWOONSESANG EXPERT ALLANTOIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. ALLANTOIN .1 mL/20mL E 20171231 51621-037_315e310a-7694-435f-8b1a-41e5fe045fd9 51621-037 HUMAN OTC DRUG DR.G DEWRINKLE BOOSTER AMPLE BY EGF GLYCERIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. GLYCERIN; DIMETHICONE 2; .1 mL/10mL; mL/10mL E 20171231 51621-038_33d8d8a3-3aa8-43dc-bba6-861f7ce5e0fe 51621-038 HUMAN OTC DRUG DR.G WHITENING BOOSTER AMPLE BY EGF GLYCERIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. GLYCERIN; DIMETHICONE 2; .1 mL/10mL; mL/10mL E 20171231 51621-039_79e4afae-20b0-4fd8-a139-04528c1bcc83 51621-039 HUMAN OTC DRUG DR.G WHITENING FORTIFIER BY EGF GLYCERIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. GLYCERIN; ALLANTOIN 6; .15 mL/30mL; mL/30mL E 20171231 51621-040_fe6a98d6-964a-40e5-b225-b0d11368acd4 51621-040 HUMAN OTC DRUG DR.G DEWRINKLE FORTIFIER BY EGF GLYCERIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. GLYCERIN; ALLANTOIN 6; .15 mL/30mL; mL/30mL E 20171231 51621-041_1e2a7c8e-4daa-4e9d-bb63-336bb11d920f 51621-041 HUMAN OTC DRUG DR.G DEWRINKLE REFORMER BY EGF DIMETHICONE CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. DIMETHICONE .5 mL/50mL E 20171231 51621-042_0e821163-ac84-4f62-a1f1-9ada36696d20 51621-042 HUMAN OTC DRUG DR.G WHITENING REFORMER BY EGF GLYCERIN CREAM CUTANEOUS 20100601 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. GLYCERIN; DIMETHICONE 10; 2 mL/50mL; mL/50mL E 20171231 51621-043_b577ae60-e13a-4b0f-b541-b5d2c17ebe46 51621-043 HUMAN OTC DRUG GOWOONSESANG EXPERT ACTIFIRM TM RECOVERY SUPER BLEMISH BASE SPF30 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.564; 1.35; .864 mL/45mL; mL/45mL; mL/45mL E 20171231 51621-044_de1c4927-df74-42d9-923e-7ff52b7c0f7d 51621-044 HUMAN OTC DRUG GOWOONSESANG PERFECT PORE COVER BB SPF 30 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.285; 1.35; .985 mL/45mL; mL/45mL; mL/45mL E 20171231 51621-050_5a219b90-ee96-983a-e053-2991aa0a75a8 51621-050 HUMAN OTC DRUG Dr.G Daily Safe BB SPF30 PA Plus Plus titanium dioxide and zinc oxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 9.4; .9 mg/100mg; mg/100mg N 20181231 51621-051_5a220c1f-2ea9-2ec9-e053-2a91aa0a464c 51621-051 HUMAN OTC DRUG Dr.G Super Light Brightening Balm SPF30 PA PLUS PLUS Titanium dioxide and Zinc oxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 9.7; 1.9 mg/100mg; mg/100mg N 20181231 51621-052_5a21a2f9-642f-93ff-e053-2a91aa0a5f0e 51621-052 HUMAN OTC DRUG Dr.G Medi UV Ultra Sun SPF 50 Plus PA Plus Plus Plus zinc oxide and titanium dioxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE 5; 4 mg/100mg; mg/100mg N 20181231 51621-056_5a219b90-ee8d-983a-e053-2991aa0a75a8 51621-056 HUMAN OTC DRUG Dr.G Radiance Dual Essence BB SPF50 Plus PA Plus Plus Plus titanium dioxide and zinc oxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 13.8; 3.9 mg/100mg; mg/100mg N 20181231 51621-057_5a219b90-ee84-983a-e053-2991aa0a75a8 51621-057 HUMAN OTC DRUG Dr.G Brightening Balm SPF30 PA Plus Plus titanium dioxide and zinc oxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 9.7; 1.9 mg/100mg; mg/100mg N 20181231 51621-058_5a2191a4-ff2c-403e-e053-2991aa0a935f 51621-058 HUMAN OTC DRUG Dr.G Perfect Pore Cover BB SPF30 PA Plus Plus titanium dioxide and zinc oxide CREAM CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 7.9; 1.9 mg/100mg; mg/100mg N 20181231 51621-061_5a2191a4-ff18-403e-e053-2991aa0a935f 51621-061 HUMAN OTC DRUG DR.G Moist Ample CC Cushion SPF50 Plus PA Plus Plus Plus Light Beige titanium dioxide and zinc oxide LIQUID CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 9.8; 7.5 mg/100mg; mg/100mg N 20181231 51621-062_5a2191a4-ff0f-403e-e053-2991aa0a935f 51621-062 HUMAN OTC DRUG Dr. G Moist Ample CC Cushion SPF 50 Plus PA Plus Plus Plus Natural Beige titanium dioxide and zinc oxide LIQUID CUTANEOUS 20141115 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 9.7; 7.5 mg/100mg; mg/100mg N 20181231 51621-089_ba095e06-b9c6-4898-a503-45e957acad03 51621-089 HUMAN OTC DRUG Derma Dr. lab Hydromoist Cover BB ZINC OXIDE CREAM TOPICAL 20180102 OTC MONOGRAPH FINAL part347 GOWOONSESANG COSMETICS CO., LTD. ZINC OXIDE .9 g/100mL N 20191231 51621-096_5a20b83b-23e5-41d3-e053-2991aa0a51a6 51621-096 HUMAN OTC DRUG GOWOONSESANG HYDRA INTENSIVE BLEMISH BALM ZINC OXIDE CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part352 GOWOONSESANG COSMETICS CO., LTD. ZINC OXIDE 1.92 g/100mL N 20181231 51621-097_5a307b3e-3c39-1731-e053-2991aa0ad9e0 51621-097 HUMAN OTC DRUG DR.G A-CLEAR FOAM Stearic Acid CREAM TOPICAL 20150705 UNAPPROVED DRUG OTHER GOWOONSESANG COSMETICS CO., LTD. STEARIC ACID 20 g/100mL N 20181231 51621-125_5a33f65a-3f0f-4cdb-e053-2a91aa0abbe7 51621-125 HUMAN OTC DRUG Dr.G Brightening Up Cushion SPF50 Plus PA Plus Plus Plus Titanium Dioxide, Niacinamide, Adenosine LIQUID TOPICAL 20161001 UNAPPROVED DRUG OTHER GOWOONSESANG COSMETICS CO., LTD. ADENOSINE; TITANIUM DIOXIDE; NIACINAMIDE .04; 8.350228; 2 g/100g; g/100g; g/100g N 20181231 51621-200_5636b9e0-7ec0-6cea-e054-00144ff88e88 51621-200 HUMAN OTC DRUG Dr.G Brightening Up Sun OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20170802 OTC MONOGRAPH NOT FINAL part352 GOWOONSESANG COSMETICS CO., LTD. OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE 70; 49; 45; 29 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 51621-201_5636b9e0-7eca-6cea-e054-00144ff88e88 51621-201 HUMAN OTC DRUG Dr.G Brightening Up Sun Stick OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE CREAM TOPICAL 20170802 OTC MONOGRAPH NOT FINAL part352 GOWOONSESANG COSMETICS CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; OCTOCRYLENE 70; 45; 29; 20 mg/g; mg/g; mg/g; mg/g N 20181231 51621-202_5636b9e0-7ed4-6cea-e054-00144ff88e88 51621-202 HUMAN OTC DRUG Dr.G Green Mild Up Sun ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20170802 OTC MONOGRAPH NOT FINAL part352 GOWOONSESANG COSMETICS CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE 116.4; 31.2 mg/mL; mg/mL N 20181231 51621-203_5636b9e0-7ede-6cea-e054-00144ff88e88 51621-203 HUMAN OTC DRUG Dr.G Water Proof Up Sun OCTINOXATE, HOMOSALATE, OCTISALATE CREAM TOPICAL 20170802 OTC MONOGRAPH NOT FINAL part352 GOWOONSESANG COSMETICS CO., LTD. OCTINOXATE; HOMOSALATE; OCTISALATE 60; 50; 40 mg/mL; mg/mL; mg/mL N 20181231 51621-204_5745e186-dd6f-3728-e053-2a91aa0a1528 51621-204 HUMAN OTC DRUG Derma Dr.lab Daily Mild Sun OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20170817 OTC MONOGRAPH NOT FINAL part352 GOWOONSESANG COSMETICS CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 75; 50; 48; 24.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 51625-001_85ebeb0a-32e1-4d7e-a628-e6980f8a86e4 51625-001 HUMAN OTC DRUG Scott-Vincent Borba Anti-Fatige 8 Hour Mineral Foundation with Broad Spectrum SPF 29 Zinc Oxide POWDER TOPICAL 20120705 OTC MONOGRAPH NOT FINAL part352 Scott-Vincent Borba ZINC OXIDE 18 g/100g E 20171231 51625-002_85ebeb0a-32e1-4d7e-a628-e6980f8a86e4 51625-002 HUMAN OTC DRUG Scott-Vincent Borba Anti-Fatige 8 Hour Mineral Foundation with Broad Spectrum SPF 29 Zinc Oxide POWDER TOPICAL 20120705 OTC MONOGRAPH NOT FINAL part352 Scott-Vincent Borba ZINC OXIDE 18 g/100g E 20171231 51625-003_85ebeb0a-32e1-4d7e-a628-e6980f8a86e4 51625-003 HUMAN OTC DRUG Scott-Vincent Borba Anti-Fatige 8 Hour Mineral Foundation with Broad Spectrum SPF 29 Zinc Oxide POWDER TOPICAL 20120705 OTC MONOGRAPH NOT FINAL part352 Scott-Vincent Borba ZINC OXIDE 18 g/100g N 20181231 51628-0001_f0314080-e037-459a-855b-78ea05c74f77 51628-0001 HUMAN OTC DRUG Natural Epsom Salt magnesium sulfate POWDER TOPICAL 20141009 OTC MONOGRAPH NOT FINAL part334 My Import USA Inc MAGNESIUM SULFATE 10 g/10g E 20171231 51628-0002_a0b1de28-b908-4bc7-8efb-157cb593d70e 51628-0002 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse for normal hair PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H My Import USA Inc PYRITHIONE ZINC 20 mg/400mg N 20181231 51628-0003_f99e2417-3f24-41dc-bc2b-7383b24d677b 51628-0003 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse for sensitive hair PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H My Import USA Inc PYRITHIONE ZINC 20 mg/400mg N 20181231 51628-1011_188b68d3-8757-485c-af87-a9f233c8a538 51628-1011 HUMAN OTC DRUG RUBBING ALCOHOL 70 PERCENT ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A MY IMPORT USA INC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 51628-1012_7cdd31ee-f113-4eb8-a9b5-eda004e5c830 51628-1012 HUMAN OTC DRUG RUBBING ALCOHOL 70 PERCENT WITH WINTERGREEN ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A MY IMPORT USA INC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 51628-1013_dd196dcd-fcbc-4d4f-9ca8-ada80e19cd44 51628-1013 HUMAN OTC DRUG RUBBING ALCOHOL 50 PERCENT ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A MY IMPORT USA INC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 51628-1014_6f3f00f6-05b7-4579-a138-2ca56155136d 51628-1014 HUMAN OTC DRUG RUBBING ALCOHOL 50 PERCENT WITH WINTERGREEN ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A MY IMPORT USA INC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 51628-3232_228b9c17-cbe7-42a7-b451-6a377aa77dff 51628-3232 HUMAN OTC DRUG Choice Personal Care Vapor Rub Camphor and Eucalyptus Oil and Menthos GEL TOPICAL 20101101 OTC MONOGRAPH FINAL part341 My Import Inc CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 5.4; 1.4; 3 g/g; g/g; g/g E 20171231 51628-3434_84305cb2-b08d-4c3e-8e63-b88bb57067cf 51628-3434 HUMAN OTC DRUG Choice Personal Care Theraputic Blue Ice Menthol GEL TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part348 My Import Inc MENTHOL 2 g/100g E 20171231 51628-3535_1ecfc2f8-3fa0-4870-aff5-0c5b37f55f57 51628-3535 HUMAN OTC DRUG Choice Personal Care Petroleum White petroleum JELLY TOPICAL 20101101 OTC MONOGRAPH FINAL part347 My Import Inc PETROLATUM 1 g/g E 20171231 51628-3636_1ecfc2f8-3fa0-4870-aff5-0c5b37f55f57 51628-3636 HUMAN OTC DRUG Choice Personal Care Baby Fresh Scented Petroleum White petroleum JELLY TOPICAL 20101101 OTC MONOGRAPH FINAL part347 My Import Inc PETROLATUM 1 g/g E 20171231 51628-3737_1ecfc2f8-3fa0-4870-aff5-0c5b37f55f57 51628-3737 HUMAN OTC DRUG Choice Personal Care Cocoa Butter Scented Petroleum White petroleum JELLY TOPICAL 20101101 OTC MONOGRAPH FINAL part347 My Import Inc PETROLATUM 1 g/g E 20171231 51630-001_0e235eb8-857f-45d7-82ce-97952329e18d 51630-001 HUMAN OTC DRUG No7 Protect and Perfect Skincare System Day Sunscreen SPF 15 Octinoxate, Avobenzone and Octisalate EMULSION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Schmid & Son Packaging OCTINOXATE; AVOBENZONE; OCTISALATE 3; 1.5; 1.25 mL/50mL; mL/50mL; mL/50mL E 20171231 51630-002_2b280670-c179-43ed-b207-b7835cb3af95 51630-002 HUMAN OTC DRUG No7 Lifting and Firming Skincare System Day Sunscreen SPF 8 Avobenzone, Octinoxate and Octisalate EMULSION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Schmid & Son Packaging OCTINOXATE; AVOBENZONE; OCTISALATE 3.75; 1.5; 1 mL/50mL; mL/50mL; mL/50mL E 20171231 51630-003_0b29bbeb-7dbd-4a41-9bb1-a93635ce06d4 51630-003 HUMAN OTC DRUG No7 Protect and Perfect Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20130118 OTC MONOGRAPH NOT FINAL part352 Schmid and Son Packaging AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3; 1.25 g/50g; g/50g; g/50g E 20171231 51630-004_489b7814-976b-4fb7-9aea-fe47eacf4ad1 51630-004 HUMAN OTC DRUG No7 Lift and Luminate Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octocrylene CREAM TOPICAL 20130122 OTC MONOGRAPH NOT FINAL part352 Schmid and Son Packaging AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5; 2.5; .5 g/50g; g/50g; g/50g E 20171231 51645-269_5df4f1bf-55b3-d0c6-e053-2991aa0ac1cb 51645-269 HUMAN OTC DRUG SINE OFF MAXIMUM STRENGTH ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20100705 OTC MONOGRAPH FINAL part341 Gemini Pharmaceuticals, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 51645-291_a6f1bd15-8e12-476c-a9b3-ebdd8e2b0bdb 51645-291 HUMAN OTC DRUG SINE OFF SINUS/COLD MEDICINE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20100705 OTC MONOGRAPH FINAL part343 Gemini Pharmaceuticals, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 500; 2; 5 mg/1; mg/1; mg/1 N 20181231 51645-703_5df51b6f-6e10-00eb-e053-2991aa0a020c 51645-703 HUMAN OTC DRUG Plus Pharma Pain Reliever,Fever Reducer ACETAMINOPHEN TABLET ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 Gemini Pharmaceuticals, Inc. dba Plus Pharma ACETAMINOPHEN 325 mg/1 N 20181231 51645-705_7121273d-b9b1-47cf-8d44-5ddd2bf61cc9 51645-705 HUMAN OTC DRUG PlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg ACETAMINOPHEN TABLET ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 Gemini Pharmaceuticals, Inc. dba Plus Pharma ACETAMINOPHEN 500 mg/1 N 20181231 51645-706_d916f2ab-5567-4b41-ae3f-0ab409d016f6 51645-706 HUMAN OTC DRUG PlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg Acetaminophen TABLET ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 Gemini Pharmaceuticals, Inc. dba Plus Pharma ACETAMINOPHEN 500 mg/1 N 20181231 51645-709_eaf9aea0-3a5a-475b-a402-86a62a30fc85 51645-709 HUMAN OTC DRUG Plus Pharma Extra Strength Acetaminophen PM Acetaminophen,Diphenhydramine HCl TABLET, FILM COATED ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 Gemini Pharmaceuticals, Inc. dba Plus Pharma ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 51645-716_127d67c5-eb2c-4062-8bc9-99700096cec5 51645-716 HUMAN OTC DRUG Plus Pharma NSAID Aspirin ASPIRIN TABLET ORAL 20060327 OTC MONOGRAPH FINAL part343 Gemini Pharmaceuticals, Inc. dba Plus Pharma ASPIRIN 325 mg/1 N 20181231 51645-735_ebb33931-177a-45d8-a5c9-a261850b3434 51645-735 HUMAN OTC DRUG Plus Pharma Calcium Antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20060327 OTC MONOGRAPH FINAL part331 Gemini Pharmaceuticals, Inc. dba Plus Pharma CALCIUM CARBONATE 500 mg/1 N 20181231 51645-745_2c20040b-b23e-50db-e054-00144ff88e88 51645-745 HUMAN OTC DRUG Plus Pharma Diphenhydramine TABLET, FILM COATED ORAL 20150612 OTC MONOGRAPH FINAL part341 Gemini Pharmaceuticals, Inc. dba Plus Pharma DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 51645-750_bb6236fa-2754-4db0-a5b5-cbe114d707b4 51645-750 HUMAN OTC DRUG PlusPHARMA Stool Softener DOCUSATE SODIUM TABLET, FILM COATED ORAL 20060327 OTC MONOGRAPH NOT FINAL part334 Gemini Pharmaceuticals, Inc. dba Plus Pharma DOCUSATE SODIUM 100 mg/1 N 20181231 51645-850_df4ed912-e463-4d6a-8889-93c8d5a48d3e 51645-850 HUMAN OTC DRUG Plus Pharma Senna Plus Standardized Senna Concentrate 8.6 mg and Docusate Sodium 50 mg Each DOCUSATE SODIUM,SENNOSIDES TABLET, FILM COATED ORAL 20060327 OTC MONOGRAPH NOT FINAL part334 Gemini Pharmaceuticals, Inc. dba Plus Pharma DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 51645-851_69957d96-0528-4707-b412-59cf1fe5a9b3 51645-851 HUMAN OTC DRUG Plus Pharma Senna Standardized Senna Concentrate 8.6 mg Sennosides Each SENNOSIDES TABLET, FILM COATED ORAL 20060327 OTC MONOGRAPH NOT FINAL part334 Gemini Pharmaceuticals, Inc. dba Plus Pharma SENNOSIDES 8.6 mg/1 N 20181231 51645-860_dc06b24f-2ac9-440e-92b4-8e575d2dfcee 51645-860 HUMAN OTC DRUG PlusPHARMA Simethicone TABLET, CHEWABLE ORAL 20060327 OTC MONOGRAPH FINAL part347 Gemini Pharmaceuticals, Inc. dba Plus Pharma DIMETHICONE 80 mg/1 N 20181231 51645-870_8ebe3de2-a9f9-4ae1-a250-b1873270f133 51645-870 HUMAN OTC DRUG Plus Pharma Simethicone TABLET, CHEWABLE ORAL 20141103 OTC MONOGRAPH FINAL part347 Gemini Pharmaceuticals, Inc. dba Plus Pharma DIMETHICONE 125 mg/1 N 20181231 51645-994_18a59c8a-6d8b-2ad0-e054-00144ff88e88 51645-994 HUMAN OTC DRUG Meclizine HCl 25 mg Meclizine Hydrochloride TABLET, CHEWABLE ORAL 20151015 OTC MONOGRAPH FINAL part336 Gemini Pharmaceuticals, Inc. dba Plus Pharma MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 51655-000_8a00251e-c746-4e11-9f5a-4e805c50f406 51655-000 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20140516 ANDA ANDA076268 Northwind Pharmaceuticals DIGOXIN .25 mg/301 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 51655-001_a474a986-17f1-456b-b543-93c12314f147 51655-001 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20140516 ANDA ANDA076268 Northwind Pharmaceuticals DIGOXIN .125 mg/301 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 51655-002_b6948d4a-cf4b-4e3a-918b-d6faef6ac0c7 51655-002 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20140516 ANDA ANDA077316 Northwind Pharmaceuticals CARVEDILOL 12.5 mg/301 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 51655-003_cdec0059-c52f-4f86-8935-ae5da1f1b8c6 51655-003 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride ER Bupropion Hydrochloride TABLET ORAL 20140601 ANDA ANDA078866 Northwind Pharmaceuticals BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 51655-004_f2f0bebd-9c2b-44ec-9355-7241b9e8d965 51655-004 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20140820 ANDA ANDA065470 Northwind Pharmaceuticals, LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 51655-005_4a64fde2-1db8-5878-e054-00144ff8d46c 51655-005 HUMAN PRESCRIPTION DRUG Phendimetrazine Phendimetrazine TABLET ORAL 20150422 ANDA ANDA091042 Northwind Pharmaceuticals PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 51655-009_7e1779df-a430-4654-80fc-95cf391c279d 51655-009 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20140507 ANDA ANDA076509 Northwind Pharmaceuticals FENOFIBRATE 160 mg/301 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 51655-010_fcef12aa-ba34-4a2c-abdd-9447cc18f3ac 51655-010 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20140520 NDA AUTHORIZED GENERIC NDA021656 Northwind Pharmaceuticals FENOFIBRATE 145 mg/301 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 51655-011_8eee627c-3fd8-415e-ab52-61eb50b9b091 51655-011 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20140601 ANDA ANDA062935 Northwind Pharmaceuticals PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 51655-012_256c47ff-6597-4d66-abe5-6340fd814464 51655-012 HUMAN PRESCRIPTION DRUG Dexamethsone Dexamethasone TABLET ORAL 20140811 ANDA ANDA084612 Northwind Pharmaceuticals, LLC DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51655-013_eb5d4ec9-b37e-4bf8-906d-381d3f09cb7f 51655-013 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20141104 ANDA ANDA075828 Northwind Pharmaceuticals, LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51655-015_a9732147-39ec-4fe9-bcb5-e27316607bd3 51655-015 HUMAN PRESCRIPTION DRUG BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET ORAL 20150225 ANDA ANDA075022 Northwind Pharmaceuticals, LLC BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 51655-017_68b0341d-59e4-43c1-a1c4-71b7907d6e3e 51655-017 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20150303 ANDA ANDA075948 Northwind Pharmaceuticals, LLC CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 51655-019_de008247-b403-47fa-9ffd-f6667c17c934 51655-019 HUMAN PRESCRIPTION DRUG CEFDINIR CEFDINIR CAPSULE ORAL 20150210 ANDA ANDA065330 Northwind Pharmaceuticals, LLC CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 51655-021_f3f7546d-0afc-46ba-8905-9e263ef1f293 51655-021 HUMAN PRESCRIPTION DRUG ESCITALOPRAM escitalopram oxalate TABLET, FILM COATED ORAL 20150209 ANDA ANDA076765 Northwind Pharmaceuticals, LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51655-022_ed3d5067-3b30-45fc-a813-791eda993b5e 51655-022 HUMAN PRESCRIPTION DRUG OMEPRAZOLE DR OMEPRAZOLE DR CAPSULE, DELAYED RELEASE ORAL 20141027 ANDA ANDA076048 Northwind Pharmaceuticals, LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 51655-023_30e7e098-a723-485d-928f-b13f51193b58 51655-023 HUMAN PRESCRIPTION DRUG OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED RELEASE ORAL 20150205 ANDA ANDA076048 Northwind Pharmaceuticals, LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 51655-025_9dd1bb2d-9158-487f-a1c7-f82ef43d6029 51655-025 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140617 ANDA ANDA062713 Northwind Pharmaceuticals CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 51655-026_18dbd24a-dd4b-4e2a-be9c-02d48078122c 51655-026 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin TABLET ORAL 20140718 ANDA ANDA065253 Northwind Pharmaceuticals, LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 51655-027_0f7228b0-773b-4355-b439-b6b6f5bd1659 51655-027 HUMAN PRESCRIPTION DRUG Loratadine Loratadine TABLET ORAL 20141027 ANDA ANDA076134 Northwind Pharmaceuticals, LLC LORATADINE 10 mg/1 N 20181231 51655-028_e84ab16b-5c05-4f83-aad8-561526d4fb9d 51655-028 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20141106 ANDA ANDA090836 Northwind Pharmaceuticals, LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 51655-029_5a54d875-0575-4e74-b406-263b69af2169 51655-029 HUMAN PRESCRIPTION DRUG CARVEDILOL CARVEDILOL TABLET, FILM COATED ORAL 20150209 ANDA ANDA077614 Northwind Pharmaceuticals, LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 51655-031_d1911c6d-7371-42dd-a4b0-b8d76d8ce0c4 51655-031 HUMAN PRESCRIPTION DRUG SUCRALFATE SUCRALFATE TABLET ORAL 20150209 ANDA ANDA070848 Northwind Pharmaceuticals, LLC SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 51655-032_28d953fd-d53b-421c-8728-d39d007a327c 51655-032 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20150210 ANDA ANDA077627 Northwind Pharmaceuticals, LLC TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 51655-035_bee0fc29-5017-472e-8a0a-b11bee969d17 51655-035 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20141028 ANDA ANDA078558 Northwind Pharmaceuticals, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-038_5b13daf5-245c-4243-af29-138b79225bb6 51655-038 HUMAN PRESCRIPTION DRUG ALLOPURINOL ALLOPURINOL TABLET ORAL 20150204 ANDA ANDA090637 Northwind Pharmaceuticals, LLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 51655-049_fe6941d6-a3aa-4dcc-a6d3-865fd95f13b0 51655-049 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20140520 ANDA ANDA078558 Northwind Pharmaceuticals IBUPROFEN 400 mg/301 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-050_a11a1b89-4de9-4a4d-a77c-7cbab4c361c8 51655-050 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20140814 ANDA ANDA090796 Northwind Pharmaceuticals, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-051_5fa42546-a9bb-4ea7-980d-8ead356ce30b 51655-051 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20140601 ANDA ANDA078558 Northwind Pharmaceuticals IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-053_71eaa8fe-12db-4b68-b8a1-7dd54a323b48 51655-053 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amolodipine Besylate TABLET ORAL 20140921 ANDA ANDA077955 Northwind Pharmaceuticals, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 51655-054_da8046b5-5bab-4c31-b660-7eb19c19688e 51655-054 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140923 ANDA ANDA077955 Northwind Pharmaceuticals, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 51655-055_3fac1172-9965-4419-bbff-93f4a585f8af 51655-055 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20141015 ANDA ANDA040656 Northwind Pharmaceuticals, LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 51655-065_3631d1dc-45e2-0588-e054-00144ff88e88 51655-065 HUMAN PRESCRIPTION DRUG Benazepril HCl Benazepril HCl TABLET ORAL 20160623 ANDA ANDA076118 Northwind Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51655-066_228331ca-13be-4110-9b3a-eedd71d91789 51655-066 HUMAN PRESCRIPTION DRUG BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET, COATED ORAL 20160304 ANDA ANDA076118 Northwind Pharmaceuticals, LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51655-067_f3da3837-01b1-49df-8a12-82587391d24a 51655-067 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride Benazepril hydrochloride TABLET, FILM COATED ORAL 20140530 ANDA ANDA076118 Northwind Pharmaceuticals BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51655-071_35e36f3c-fc38-4dfd-a4ef-f7ad3879fc99 51655-071 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20141112 ANDA ANDA077751 Northwind Pharmaceuticals, LLC PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51655-072_3f32e8dd-e412-494b-8d3e-d793070402d5 51655-072 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20140710 ANDA ANDA077751 Northwind Pharmaceuticals, LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51655-073_aeffdfbb-5721-46e1-829f-fd545b9b5864 51655-073 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20141112 ANDA ANDA076056 Northwind Pharmaceuticals, LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51655-078_db5d3eb6-ca9e-4562-bee4-ca54e2c2abc0 51655-078 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET ORAL 20140915 ANDA ANDA040804 Northwind Pharmaceuticals, LLC HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 51655-079_57b04227-0e69-4ada-80ed-2f9e6ccc4e2a 51655-079 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20150226 ANDA ANDA040804 Northwind Pharmaceuticals, LLC HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 51655-085_92aa2695-ebb7-4e26-8ef1-0c3fda2b530a 51655-085 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride TABLET ORAL 20140601 ANDA ANDA091179 Northwind Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51655-089_738fba50-2fba-446c-af05-5eee1dd79487 51655-089 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20141008 ANDA ANDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-091_e561a5af-c541-4ef0-b027-9d1af884ac72 51655-091 HUMAN PRESCRIPTION DRUG Levothyroxine Levothyroxine TABLET ORAL 20140710 NDA NDA021342 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-092_6ef21e8d-473a-4a1c-a9a2-ecc0e7dbc0ce 51655-092 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20140731 NDA NDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-094_ca663e1b-16e0-4ed8-a281-ea3baedf8acd 51655-094 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20141021 NDA NDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-095_c5f3891e-1d86-4dbe-940f-483494669c91 51655-095 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20141217 NDA NDA021342 Northwind Pharmaceuticals LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-096_daf3e067-b54c-463a-ac6b-4d0c316cf42d 51655-096 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET ORAL 20140428 ANDA ANDA040268 Northwind Pharmaceuticals PROCHLORPERAZINE MALEATE 5 mg/61 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51655-099_b4cd2005-abc9-46fd-9209-df6b57b8f730 51655-099 HUMAN PRESCRIPTION DRUG acyclovir Acyclovir TABLET ORAL 20140514 ANDA ANDA075382 Northwind Pharmaceuticals ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 51655-100_014435f6-f88d-4970-8500-7b0a02558df0 51655-100 HUMAN PRESCRIPTION DRUG fluoxetine hydrochloride fluoxetine hydrochloride CAPSULE ORAL 20140520 ANDA ANDA078619 Northwind Pharmaceuticals FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51655-101_1371cbfe-0382-47cc-b787-927b6c328df0 51655-101 HUMAN PRESCRIPTION DRUG fluoxetine hydrochloride fluoxetine hydrochloride CAPSULE ORAL 20141103 ANDA ANDA076001 Northwind Pharmaceuticals, LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51655-102_aad50742-6e1c-433d-9d92-01d8385d14e0 51655-102 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20140825 ANDA ANDA075511 Northwind Pharmaceuticals,LLC FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 51655-103_152b12c4-f153-47d0-af0c-51255a7adc77 51655-103 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20150204 ANDA ANDA077911 Northwind Pharmaceuticals, LLC GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 51655-105_ab615d0d-ab59-4d12-badd-670a882954e6 51655-105 HUMAN PRESCRIPTION DRUG GLIPIZIDE GLIPIZIDE TABLET ORAL 20141229 ANDA ANDA077820 Northwind Pharmaceuticals GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 51655-106_ee8c48fa-a3a5-4909-b6a3-dd49826e9e1c 51655-106 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20141230 ANDA ANDA075795 Northwind Pharmaceuticals GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 51655-107_dbceffa8-8d86-4e96-8657-cb5ebdb22b63 51655-107 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20140724 ANDA ANDA040659 Northwind Pharmaceuticals, LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 51655-108_fbb5b5be-adbc-4d73-b40d-8a323a793f5b 51655-108 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET, FILM COATED ORAL 20141229 ANDA ANDA075511 Northwind Pharmaceuticals FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 51655-111_57112ce4-1d1f-43ba-b1f4-adbbab735a1d 51655-111 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140515 ANDA ANDA076817 Northwind Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 51655-112_cb8e448c-9616-462d-a412-94af74c2ad17 51655-112 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20140303 ANDA ANDA040596 Northwind Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51655-114_6403bb54-d54c-46a4-876c-b5dcbe7660d0 51655-114 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride TABLET ORAL 20140520 ANDA ANDA040596 Northwind Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/301 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51655-117_efbd9543-b8ae-43ef-8551-f0733760c751 51655-117 HUMAN PRESCRIPTION DRUG RAMIPRIL RAMIPRIL TABLET ORAL 20141230 ANDA ANDA076549 Northwind Pharmaceuticals RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51655-118_b8fa8de7-dac7-4d6c-a12c-96359843471f 51655-118 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20140601 ANDA ANDA076639 Northwind Pharmaceuticals CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 51655-120_7ef19d90-4429-47d8-894c-0da328123014 51655-120 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20141229 ANDA ANDA078181 Northwind Pharmaceuticals GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 51655-122_05548cb8-6ee3-47a4-960e-6b2d576240aa 51655-122 HUMAN PRESCRIPTION DRUG LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM TABLET ORAL 20141229 ANDA ANDA200295 Northwind Pharmaceuticals LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 51655-123_4a3e2edf-4f5e-66a9-e054-00144ff8d46c 51655-123 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20141216 ANDA ANDA079067 Northwind Pharmaceuticals METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 51655-124_54b002f1-1a91-46c8-b549-970d2f43c465 51655-124 HUMAN PRESCRIPTION DRUG NP THYROID 90 levothyroxine and liothyronine TABLET ORAL 20141229 UNAPPROVED DRUG OTHER Northwind Pharmaceuticals LEVOTHYROXINE; LIOTHYRONINE 57; 13.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 51655-125_4afc9b83-70f5-4d70-a7e2-6fb333dd7ae6 51655-125 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140620 ANDA ANDA065229 Northwind Pharmaceuticals CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 51655-126_0ad79730-c47e-49b0-b9f2-c1766b19c741 51655-126 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140821 ANDA ANDA040807 Northwind Pharmaceuticals, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51655-127_21938319-b511-49a7-a4a0-39e9b649f589 51655-127 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20140914 ANDA ANDA079237 Northwind Pharmaceuticals, LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51655-129_0a9e895c-acfd-4333-8546-4fead9d769a4 51655-129 HUMAN PRESCRIPTION DRUG thyroid, porcine thyroid, porcine TABLET ORAL 20150105 UNAPPROVED DRUG OTHER Northwind Pharmaceuticals THYROID, PORCINE 120 mg/1 N 20181231 51655-131_6c9ee14a-df87-4ebb-afc8-f717529ed4f7 51655-131 HUMAN PRESCRIPTION DRUG SILDENAFIL SILDENAFIL TABLET, FILM COATED ORAL 20141106 ANDA ANDA091479 Northwind Pharmaceuticals, LLC SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 51655-132_13eb9e8d-bd5b-4406-90f3-08a18e7290fc 51655-132 HUMAN PRESCRIPTION DRUG NP THYROID 60 NP THYROID 60 TABLET ORAL 20150212 UNAPPROVED DRUG OTHER Northwind Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 38; 9 uCi/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 51655-134_fedb3c26-084b-4741-82e0-4e78ed60a8ba 51655-134 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET ORAL 20150226 ANDA ANDA087128 Northwind Pharmaceuticals, LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 51655-141_389f19d2-25dd-40aa-828e-7e0780110109 51655-141 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20140923 ANDA ANDA086988 Northwind Pharmaceuticals, LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 51655-142_b8b092e5-6eb9-4a6b-98e6-2f71f687f9ea 51655-142 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20141023 ANDA ANDA077836 Northwind Pharmaceuticals, LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 51655-151_2ba31b0a-87b0-4949-871d-d682f12ba8cd 51655-151 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20140321 ANDA ANDA076765 Northwind Pharmaceuticals ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51655-154_7f787179-6486-488b-ad2d-dcf58812a854 51655-154 HUMAN PRESCRIPTION DRUG Phenazopyridine hydrochloride Phenazopyridine hydrochloride TABLET ORAL 20140601 UNAPPROVED DRUG OTHER Northwind Pharmaceuticals PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 51655-155_873411d8-d58b-40cb-a394-98fc4adde2eb 51655-155 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20140724 UNAPPROVED DRUG OTHER Northwind Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 51655-156_74ff0527-bbf9-4288-81fd-abb7eddd075c 51655-156 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20141106 ANDA ANDA065271 Northwind Pharmaceuticals, LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 51655-157_7a891dd1-ed56-4f00-89fb-2d6be99252c9 51655-157 HUMAN PRESCRIPTION DRUG Amoxicillan Amoxicillan CAPSULE ORAL 20140601 ANDA ANDA062881 Northwind Pharmaceuticals AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 51655-158_c07e72b4-3106-4cd3-acd8-365121c5e687 51655-158 HUMAN PRESCRIPTION DRUG Amoxicillan and clavulanate potassium Amoxicillan and clavulanate potassium TABLET, FILM COATED ORAL 20140718 ANDA ANDA091569 Northwind Pharmaceuticals, LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 51655-159_9c806097-3e17-4611-b18d-ec76528f20eb 51655-159 HUMAN PRESCRIPTION DRUG Amoxicillan Amoxicillan TABLET ORAL 20140718 ANDA ANDA062058 Northwind Pharmaceuticals,LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 51655-160_d8c1bbab-8384-4098-92f5-d3446aa8f541 51655-160 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20140718 ANDA ANDA065096 Northwind Pharmaceuticals. LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 51655-162_69c4836e-6de5-4525-8689-b81c3fd807cd 51655-162 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20140212 ANDA ANDA203399 Northwind Pharmaceuticals METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 51655-163_87d1b2d2-6d3e-4828-a956-12f863fd62a8 51655-163 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20140401 NDA NDA013217 Northwind Pharmaceuticals METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 51655-165_76489519-031d-4c8e-a423-a8484eab5730 51655-165 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET ORAL 20141029 ANDA ANDA075074 Northwind Pharmaceuticals, LLC ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-166_4c35c142-b89f-4536-85bd-ec8c006ab53f 51655-166 HUMAN PRESCRIPTION DRUG ETODOLAC ETODOLAC CAPSULE ORAL 20141113 ANDA ANDA075419 Northwind Pharmaceuticals, LLC ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-167_3632036c-283f-7194-e054-00144ff8d46c 51655-167 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20160127 ANDA ANDA040445 Northwind Pharmaceuticals METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 51655-170_9151a121-dc59-4525-83aa-81a5aa2eaca6 51655-170 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20140715 ANDA ANDA074754 Northwind Pharmaceuticals, LLC KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 51655-182_5bee381f-b14b-e62b-e053-2991aa0a3c2b 51655-182 HUMAN PRESCRIPTION DRUG Tramadol HCl Tramadol HCl TABLET, FILM COATED ORAL 20171003 ANDA ANDA090404 Northwind Pharmaceuticals TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 51655-184_05a17f94-218e-49aa-9d33-6a0d832f40b2 51655-184 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20140915 ANDA ANDA062031 Northwind Pharmaceuticals DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 51655-185_39dcdd81-7699-4582-8a85-f763d7d73e18 51655-185 HUMAN PRESCRIPTION DRUG Ultram TRAMADOL HCL TABLET, COATED ORAL 20140213 ANDA ANDA076003 NORTHWIND PHARMACEUTICALS TRAMADOL HYDROCHLORIDE 50 mg/201 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 51655-186_ec7aaef1-b7f4-4b7c-962e-df2bbc773945 51655-186 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140506 ANDA ANDA076899 Northwind Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/281; mg/281 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 51655-187_a40c09d8-61dd-4cd3-8f7d-26c2150664e4 51655-187 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140506 ANDA ANDA071017 Northwind Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1411; mg/1411 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 51655-189_49502689-685c-4fd3-b1a4-3d1f76d61581 51655-189 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET ORAL 20140917 ANDA ANDA070033 Northwind Pharmaceuticals, LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 51655-190_f8bf4db8-de89-4b75-b97e-b31d9b59fbd7 51655-190 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150115 ANDA ANDA079067 Northwind Pharmaceuticals METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 51655-214_6975ec56-9942-452c-8a09-d6eea291c97d 51655-214 HUMAN PRESCRIPTION DRUG CEFDINIR CEFDINIR CAPSULE ORAL 20140917 ANDA ANDA065368 Northwind Pharmaceuticals, LLC CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 51655-232_7fa0a064-8604-41e1-af38-facea0c9c0ab 51655-232 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140730 ANDA ANDA077321 Northwind Pharmaceuticals, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51655-246_d3a1c3be-5b4c-45a3-a8ef-a103f337050d 51655-246 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20141223 ANDA ANDA090705 Northwind Pharmaceuticals GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51655-249_9ab433d7-6ab8-49b4-9b56-153743310f99 51655-249 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150514 ANDA ANDA200839 Northwind Pharmaceuticals LEVOFLOXACIN 250 mg/1 N 20181231 51655-250_1b0811e1-8f5b-4d6f-8985-62717e13ae2d 51655-250 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20140303 ANDA ANDA200839 Northwind Pharmaceuticals LEVOFLOXACIN 500 mg/1 N 20181231 51655-278_2493006e-3575-4f60-8144-1b328c7ee057 51655-278 HUMAN PRESCRIPTION DRUG WARFARIN SODIUM WARFARIN SODIUM TABLET ORAL 20150310 ANDA ANDA040145 Northwind Pharmaceuticals, LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 51655-279_978f67f2-e58a-4843-b1a5-892b60a0a1f5 51655-279 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20141209 ANDA ANDA075483 Northwind Pharmaceuticals, LLC ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51655-282_2d9cf906-e79a-40e6-a7c1-1f179b312754 51655-282 HUMAN PRESCRIPTION DRUG WARFARIN SODIUM WARFARIN SODIUM TABLET ORAL 20150310 ANDA ANDA040663 Northwind Pharmaceuticals, LLC WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 51655-283_837a0699-2324-451c-bd28-9b168fe135e5 51655-283 HUMAN PRESCRIPTION DRUG WARFARIN SODIUM WARFARIN SODIUM TABLET ORAL 20150310 ANDA ANDA040663 Northwind Pharmaceuticals, LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 51655-290_64f1daf6-af49-4087-a874-974fed3ecb79 51655-290 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE LEVOTHYROXINE TABLET ORAL 20140914 NDA AUTHORIZED GENERIC NDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-292_c41e1d8c-c11b-4186-8b0d-57cc7530638a 51655-292 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20150310 ANDA ANDA076059 Northwind Pharmaceuticals, LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51655-293_dcf2178c-cef8-4123-962d-e972189b3dbe 51655-293 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20141103 NDA NDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-294_05bb67cd-8411-485c-a745-6adb17662b7f 51655-294 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20141125 NDA NDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-295_51de998e-fea5-4bf9-8d0f-c465b18c1dbe 51655-295 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20141217 NDA NDA021342 Northwind Pharmaceuticals LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-297_d96823e2-bdbe-4186-95f5-dcfe539640e3 51655-297 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20141223 NDA NDA021210 Northwind Pharmaceuticals LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-298_fba604fe-c2bb-4fba-8910-17e733506a8f 51655-298 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20150203 NDA NDA021210 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-299_e686b2b7-d5b1-4230-910a-e8b7d3cb5a90 51655-299 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20150204 NDA NDA021342 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-300_822abde4-388b-4e14-a42f-3df7e7b9e787 51655-300 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20141022 ANDA ANDA203834 Northwind Pharmaceuticals, LLC ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 51655-301_9dccd222-84fc-4190-b5fa-2f100d999e2e 51655-301 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140507 ANDA ANDA076549 Northwind Pharmaceuticals RAMIPRIL 10 mg/301 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51655-308_0cda0108-e1b3-4d69-8894-ee9599b359d6 51655-308 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM DR DICLOFENAC SODIUM TABLET, DELAYED RELEASE ORAL 20150116 ANDA ANDA074514 Northwind Pharmaceuticals DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-318_43f30617-de6a-47e3-a715-e41f45b20d14 51655-318 HUMAN PRESCRIPTION DRUG Propranolol Hyrochloride Propranolol Hydrochloride TABLET ORAL 20140515 ANDA ANDA070213 Northwind Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 10 mg/301 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51655-320_abd6c038-2c14-4d9a-88a4-b823a8874b28 51655-320 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140501 ANDA ANDA088832 Northwind Pharmaceuticals PREDNISONE 20 mg/201 N 20181231 51655-320_b9bb8a5e-0706-459f-917c-77e8fcacffa2 51655-320 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140429 ANDA ANDA088832 Northwind Pharmaceuticals PREDNISONE 20 mg/201 N 20181231 51655-352_035c8fa3-716d-4d70-a880-023fc4aa9372 51655-352 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20140711 ANDA ANDA077670 Northwind Pharmaceuticals, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51655-353_6ce00153-16ab-42c7-b12c-961ee399682b 51655-353 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET ORAL 20150225 ANDA ANDA070974 Northwind Pharmaceuticals, LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 51655-362_96a7c367-d1e4-421a-9cb4-6b40570b0f92 51655-362 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20140924 ANDA ANDA070975 Northwind Pharmaceuticals, LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 51655-376_f81393a1-0bb9-47de-bab6-0c06c0daab8d 51655-376 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20140601 ANDA ANDA040755 Northwind Pharmaceuticals CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 51655-381_4a3efe52-7f76-25a1-e054-00144ff8d46c 51655-381 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20170224 ANDA ANDA202112 Northwind Pharmaceuticals GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 51655-391_691af6ba-bce1-4977-b03b-3180ca53d8e1 51655-391 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20140714 ANDA ANDA080937 Northwind Pharmaceuticals, LLC ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 51655-400_3b21ffaa-d097-438d-b14b-f403d9f97608 51655-400 HUMAN PRESCRIPTION DRUG Ondansetron HCL Ondansetron HCL TABLET, COATED ORAL 20140317 ANDA ANDA077851 Northwind Pharmaceuticals ONDANSETRON HYDROCHLORIDE 4 mg/31 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 51655-401_fb21d11f-0e65-484e-93a5-111b850bf67c 51655-401 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140520 ANDA ANDA077321 Northwind Pharmaceuticals LISINOPRIL 10 mg/301 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51655-402_765927a0-c165-4e9d-ab40-051d41b03a9d 51655-402 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20141117 ANDA ANDA075994 Northwind Pharmaceuticals, LLC LISINOPRIL 10 1/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51655-408_704ea6a9-118f-497c-b9dc-435ce1142f90 51655-408 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20141121 ANDA ANDA075994 Northwind Pharmaceuticals, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51655-410_7ca135fd-320e-4019-b572-0319d6372205 51655-410 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140428 ANDA ANDA085162 Northwind Pharmaceuticals PREDNISONE 10 mg/201 N 20181231 51655-412_c8caabb2-8abb-4614-8258-1ab6367fd789 51655-412 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20140729 ANDA ANDA077912 Northwind Pharmaceuticals, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51655-413_0dfdb771-023a-4426-bfc7-49a5e896232f 51655-413 HUMAN PRESCRIPTION DRUG Lisinopril and HCTZ Lisinopril and Hydrochlorothiazide TABLET ORAL 20140710 ANDA ANDA077912 Northwind Pharmaceuticals, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 51655-414_76748dbe-7cfc-4905-8075-aad9a062aacb 51655-414 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20140825 ANDA ANDA076194 Northwind Pharmaceuticals, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51655-425_82dfc095-30e3-441a-a9b6-5276a049f5a6 51655-425 HUMAN PRESCRIPTION DRUG Clemastine Fumarate Clemastine Fumarate TABLET ORAL 20140428 ANDA ANDA073283 Northwind Pharmaceuticals, LLC CLEMASTINE FUMARATE 2.68 mg/1 N 20181231 51655-439_96c19934-b215-4c4a-baa7-a3ac8a3285f5 51655-439 HUMAN PRESCRIPTION DRUG Cyclobenzaprine hydrochloride Cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20140516 ANDA ANDA073144 Northwind Pharmaceuticals CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/301 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 51655-440_7587c923-3dfe-4511-b49a-bec9ea331682 51655-440 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20141124 ANDA ANDA071611 Northwind Pharmaceuticals, LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 51655-442_b3a9b92a-0de7-446c-9815-81be40289927 51655-442 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20150317 ANDA ANDA077797 Northwind Pharmaceuticals, LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 51655-455_e7c5e5ad-85f5-41c5-bb05-33890e8c07be 51655-455 HUMAN PRESCRIPTION DRUG IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20150306 ANDA ANDA084937 Northwind Pharmaceuticals, LLC IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51655-495_616a2610-d841-74c3-e053-2a91aa0a49d5 51655-495 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20171219 ANDA ANDA078281 Northwind Pharmaceuticals PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 51655-500_abee16aa-a278-4e4e-bbce-3b2f0599ba2f 51655-500 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed Release Pantoprazole Sodium Delayed Release TABLET, DELAYED RELEASE ORAL 20140321 ANDA ANDA090970 Northwind Pharmaceuticals PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 51655-501_9fe62b0e-e0ec-4b5b-8431-d211b60a85c3 51655-501 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium DR Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140716 ANDA ANDA077056 Northwind Pharmaceuticals, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 51655-502_c6c85e4a-8c29-406b-b9db-7d185f697ad9 51655-502 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20150306 ANDA ANDA202556 Northwind Pharmaceuticals, LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51655-530_0af35e27-d4d7-4fed-9a51-8bd35bfe839e 51655-530 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20140601 ANDA ANDA065442 Northwind Pharmaceuticals CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 51655-535_fb98ff8e-3de0-4300-b6c7-5401d5856239 51655-535 HUMAN PRESCRIPTION DRUG Metoprolol Tartate Metoprolol Tartate TABLET ORAL 20140602 ANDA ANDA074644 Northwind Pharmaceuticals METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51655-536_1eed2ae0-5b11-49ba-abe3-9835516738f7 51655-536 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20140919 ANDA ANDA074644 Northwind Pharmaceuticals, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51655-547_507afe22-33ab-4fc5-95c7-74dfd5dda6cd 51655-547 HUMAN PRESCRIPTION DRUG Loperamide hydrochloride Loperamide hydrochloride CAPSULE ORAL 20141022 ANDA ANDA073192 Northwind Pharmaceuticals, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 51655-549_40b46ae3-defa-4ad5-b27d-88c7837c9c96 51655-549 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20150109 ANDA ANDA075967 Northwind Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51655-550_fd289a35-1096-43a6-88fe-5bc685961eaa 51655-550 HUMAN PRESCRIPTION DRUG Metformin hydrochloride ER Metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20140423 ANDA ANDA076706 Northwind Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51655-551_2f2c9853-4107-4d93-9d00-cc2175ee75eb 51655-551 HUMAN PRESCRIPTION DRUG Metformin HCl ER Metformin Hydrochloride Extended Release TABLET ORAL 20150522 ANDA ANDA077336 Northwind Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51655-560_92c61dfb-ce98-4cb1-bd75-a80f17e3915e 51655-560 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20140408 ANDA ANDA090564 Northwind Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51655-561_e960c42f-f668-4819-9a36-ad10c860afdc 51655-561 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20140430 ANDA ANDA090564 Northwind Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51655-562_c7ae5667-dab8-42b6-9224-86f284b16536 51655-562 HUMAN PRESCRIPTION DRUG Metformin hydrochloride ER Metformin hydrochloride ER TABLET ORAL 20140601 ANDA ANDA076869 Northwind Pharmaceuticals METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51655-563_f0cfe3b0-58ce-48d0-ba91-59a1e8c86442 51655-563 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20150121 ANDA ANDA090564 Northwind Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51655-573_4d382c97-704e-1603-e054-00144ff8d46c 51655-573 HUMAN PRESCRIPTION DRUG Metoprolol Succinate ER Metoprolol Succinate ER TABLET, EXTENDED RELEASE ORAL 20160407 ANDA ANDA078889 Northwind Pharmaceuticals METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51655-577_e71faa0e-0911-4b51-ad5a-a86930217f65 51655-577 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20140402 ANDA ANDA077927 Northwind Pharmaceuticals MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-580_29d4a7fc-d528-41c5-b180-3bef81100879 51655-580 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140507 ANDA ANDA076862 Northwind Pharmaceuticals METOPROLOL SUCCINATE 50 mg/301 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51655-581_43621eb3-651a-4a60-94d1-c422db1d2c6e 51655-581 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140506 ANDA ANDA077118 Northwind Pharmaceuticals METOPROLOL SUCCINATE 25 mg/301 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51655-584_be7dcdea-dbe5-444b-8684-a0eab99e2676 51655-584 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20140912 ANDA ANDA074644 Northwind Pharmaceuticals, LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51655-585_6c70ed2b-67cd-4dd5-a5dc-524c4d95475f 51655-585 HUMAN PRESCRIPTION DRUG Potassium Chloride ER Potassium Chloride TABLET ORAL 20141022 ANDA ANDA076368 Northwind Pharmaceuticals, LLC POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 51655-587_7189242f-370a-43ea-b08d-a962eb89d6da 51655-587 HUMAN PRESCRIPTION DRUG Potassium Chloride ER Potassium Chloride ER TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140121 NDA NDA018279 Northwind Pharmaceuticals POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 51655-588_0e68f892-a948-44db-9fca-cb3f798fdde0 51655-588 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride TABLET ORAL 20140519 ANDA ANDA040596 Northwind Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/301 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51655-590_ce2a7def-bab2-46e7-a055-9240f5c4ba1e 51655-590 HUMAN PRESCRIPTION DRUG Butalbital Acetaminophen and Caffeine Butalbital Acetaminophen and Caffeine TABLET ORAL 20150513 ANDA ANDA089175 Northwind Pharmaceuticals BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 51655-600_87fa25f6-1665-4327-b5e6-127805754cda 51655-600 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20141028 ANDA ANDA091083 Northwind Pharmaceuticals, LLC NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-608_022934b0-139e-4356-87b4-b8600854cb32 51655-608 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20150202 ANDA ANDA077627 Northwind Pharmaceuticals, LLC TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 51655-609_397d5ce6-59c1-4b03-be16-dc55f8be0f94 51655-609 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141106 ANDA ANDA077627 Northwind Pharmaceuticals, LLC TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 51655-610_c9a109ab-1c3d-46f0-ba6b-b9c8fcd21d1e 51655-610 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20140425 ANDA ANDA076477 Northwind Pharmaceuticals ATORVASTATIN CALCIUM 10 mg/301 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51655-611_1359b74c-ac4a-4f16-83e0-36c8529a53a2 51655-611 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin CAPSULE ORAL 20140718 NDA NDA020064 Northwind Pharmaceuticals, LLC NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 51655-614_30f9e52a-9799-4d3a-9392-d692c53d6047 51655-614 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20150825 ANDA ANDA091624 Northwind Pharmaceuticals ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51655-624_a4457b00-0430-490e-9e7e-861fa361f826 51655-624 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140714 ANDA ANDA074661 Northwind Pharmaceuticals, LLC NAPROXEN SODIUM 220 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-626_c4dec1eb-a9db-4594-ab43-3ced16738fde 51655-626 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20140528 ANDA ANDA078250 Northwind Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-627_1aadd4c5-f8f9-4b97-825f-ab2855a611a0 51655-627 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen TABLET ORAL 20140807 ANDA ANDA078432 Northwind Pharmaceuticals, LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-628_bf547f77-f9d8-475d-8bf5-4ec40b616b0f 51655-628 HUMAN PRESCRIPTION DRUG Naproxen Delayed Release Naproxen Delayed Release TABLET, DELAYED RELEASE ORAL 20140516 ANDA ANDA091432 Northwind Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-630_3a02772e-2e3b-4a93-ac78-59e5a45e4bdb 51655-630 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20140407 ANDA ANDA071251 Northwind Pharmaceuticals TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51655-631_3e5578c8-0ec6-4c3a-a193-5ebf4024c34c 51655-631 HUMAN PRESCRIPTION DRUG TRIAMTERENE AND HYDROCHLOROTHIAZIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET ORAL 20150303 ANDA ANDA071851 Northwind Pharmaceuticals, LLC TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51655-634_ae73e6db-4fa3-459c-8b14-11d4404a183c 51655-634 HUMAN PRESCRIPTION DRUG TRAZODONE TRAZODONE TABLET ORAL 20141201 ANDA ANDA071523 Northwind Pharmaceuticals, LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 51655-637_50844cde-b5be-487d-9ac2-145c82ca000c 51655-637 HUMAN PRESCRIPTION DRUG Armour thyroid Armour thyroid TABLET ORAL 20141107 UNAPPROVED DRUG OTHER Northwind Pharmaceuticals, LLC THYROID, PORCINE 60 mg/1 N 20181231 51655-638_29d3764c-c67b-4505-8f2d-c4949427d1f3 51655-638 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20141107 ANDA ANDA090568 Northwind Pharmaceuticals, LLC ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 51655-640_134d5370-36cc-4d6e-96ab-e2cff0247a26 51655-640 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20140403 ANDA ANDA076477 Northwind Pharmaceuticals ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51655-641_868fd6e1-2f35-441c-8a23-4d215a486c54 51655-641 HUMAN PRESCRIPTION DRUG liothyronine sodium liothyronine sodium TABLET ORAL 20141112 ANDA ANDA200295 Northwind Pharmaceuticals, LLC LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 51655-648_50ad9d8d-04cf-67d8-e054-00144ff88e88 51655-648 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 20170314 ANDA ANDA062396 Northwind Pharmaceuticals DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 51655-650_e9edf98f-0e55-4c3e-b82c-343ddad744d9 51655-650 HUMAN PRESCRIPTION DRUG atorvastatin calcium atorvastatin calcium TABLET, FILM COATED ORAL 20141008 ANDA ANDA091624 Northwind Pharmaceuticals, LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51655-652_f1f70579-c064-459a-a886-86a0c0704e6e 51655-652 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET, FILM COATED ORAL 20141113 ANDA ANDA077492 Northwind Pharmaceuticals, LLC VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 51655-664_efe69316-eae5-4cbb-9dfa-14ce83dc0f10 51655-664 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET ORAL 20150216 ANDA ANDA078216 Northwind Pharmaceuticals, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51655-670_7bdada38-7f1e-4e26-9585-195d1bfb1a57 51655-670 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET ORAL 20140403 ANDA ANDA077032 Northwind Pharmaceuticals CITALOPRAM HYDROBROMIDE 40 mg/301 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51655-675_f751ffef-914c-4e69-8073-75264391a5e2 51655-675 HUMAN PRESCRIPTION DRUG TERAZOSIN terazosin hydrochloride CAPSULE ORAL 20150227 ANDA ANDA075317 Northwind Pharmaceuticals, LLC TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51655-676_3a44b1b3-4d38-4347-8524-20445e2f0b8d 51655-676 HUMAN PRESCRIPTION DRUG TERAZOSIN terazosin hydrochloride CAPSULE ORAL 20150227 ANDA ANDA075317 Northwind Pharmaceuticals, LLC TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51655-677_668dc34f-a492-4bca-bed6-e2d2cb0175e3 51655-677 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20150227 ANDA ANDA202433 Northwind Pharmaceuticals, LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 51655-678_4509e08a-61f5-4725-9aae-e05104f510ed 51655-678 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR TABLET ORAL 20150303 ANDA ANDA075382 Northwind Pharmaceuticals ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 51655-681_ed1c2498-b8dd-4708-b009-0c928f534f53 51655-681 HUMAN PRESCRIPTION DRUG RANITIDINE ranitidine hydrochloride TABLET ORAL 20140915 ANDA ANDA077824 Northwind Pharmaceuticals, LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 51655-685_ad0b72df-bd8e-44ed-bf7d-9889e29af44e 51655-685 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140826 ANDA ANDA078250 Northwind Pharmaceuticals, LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-720_558b1937-a29c-32b1-e054-00144ff8d46c 51655-720 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20151009 ANDA ANDA065248 Northwind Pharmaceuticals CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 51655-731_86d12c37-dedb-4409-b0b8-5b67725551d3 51655-731 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20150105 ANDA ANDA077927 Northwind Pharmaceuticals MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-741_46f1a3d0-5675-69f0-e054-00144ff8d46c 51655-741 HUMAN PRESCRIPTION DRUG Tizanidine HCl Tizanidine HCl TABLET ORAL 20170125 ANDA ANDA091283 Northwind Pharmaceuticals TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 51655-749_cd99058f-0a08-4ac8-8caf-4327c99797c1 51655-749 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20140903 NDA NDA021342 Northwind Pharmaceuticals, LLC LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 51655-751_3058d174-bff7-49db-8ca1-fa2d61898b9e 51655-751 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150107 ANDA ANDA077492 Northwind Pharmaceuticals VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 51655-769_280f9437-8d0e-1a25-e054-00144ff8d46c 51655-769 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE TABLET ORAL 20141208 ANDA ANDA040627 Northwind Pharmaceuticals, LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 51655-770_4a29020f-31db-212b-e054-00144ff8d46c 51655-770 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20140725 ANDA ANDA040749 Northwind Pharmaceuticals, LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 51655-771_378b0baf-91de-4687-9dd2-cb37498643e6 51655-771 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20150115 ANDA ANDA040587 Northwind Pharmaceuticals BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 51655-772_ec9bda2c-edcd-4f80-bfd7-8b543bd51af3 51655-772 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE, LIQUID FILLED ORAL 20150312 ANDA ANDA040682 Northwind Pharmaceuticals, LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 51655-773_ec18e10d-91a1-4d20-8a6b-ddcc5ea9c44c 51655-773 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE, LIQUID FILLED ORAL 20150312 ANDA ANDA040682 Northwind Pharmaceuticals BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 51655-800_2b86d942-c970-449f-bd27-bd0ba9ede1c3 51655-800 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20141230 ANDA ANDA077851 Northwind Pharmaceuticals ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 51655-802_cea4b272-8e61-452d-9ea3-ceff10a203dd 51655-802 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE Codeine Phosphate and APAP TABLET ORAL 20140718 ANDA ANDA040779 Northwind Pharmaceuticals, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 51655-803_ae78a4b7-4973-4962-b515-2db14e716dce 51655-803 HUMAN PRESCRIPTION DRUG ONDANSETRON ondansetron hydrochloride TABLET, FILM COATED ORAL 20150223 ANDA ANDA077851 Northwind Pharmaceuticals, LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 51655-804_2dddb4be-83ee-0cbe-e054-00144ff88e88 51655-804 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20150731 ANDA ANDA201013 Northwind Pharmaceuticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 51655-808_48a7e42b-9350-4ec6-e054-00144ff88e88 51655-808 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20160929 ANDA ANDA202800 Northwind Pharmaceuticals CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 51655-810_3bb3b80a-30e9-62fe-e054-00144ff8d46c 51655-810 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20150930 ANDA ANDA074223 Northwind Pharmaceuticals GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 51655-822_795c87fe-3c10-4d82-abdc-2a564f12b29d 51655-822 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140601 ANDA ANDA072927 Northwind Pharmaceuticals LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51655-830_410d1ab4-cd1f-2b24-e054-00144ff88e88 51655-830 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET ORAL 20161111 ANDA ANDA077397 Northwind Pharmaceuticals, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51655-838_8d71b3e9-4182-4e3a-b870-01a60d75c18d 51655-838 HUMAN PRESCRIPTION DRUG SPIRONOLACTONE SPIRONOLACTONE TABLET, FILM COATED ORAL 20140915 ANDA ANDA040353 Northwind Pharmaceuticals, LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 51655-851_26cd56b0-edbc-74f3-e054-00144ff8d46c 51655-851 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20151104 ANDA ANDA075682 Northwind Pharmaceuticals IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51655-865_37be8bf7-3b24-48ac-a562-9021bd622320 51655-865 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20140601 ANDA ANDA074569 Northwind Pharmaceuticals CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 51655-872_576dfd47-97db-25a3-e053-2a91aa0ad9d8 51655-872 HUMAN PRESCRIPTION DRUG Phentermine HCl Phentermine HCl CAPSULE ORAL 20170822 ANDA ANDA040886 Northwind Pharmaceuticals PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 51655-875_f34fbc55-732a-4573-a843-33c0f325571b 51655-875 HUMAN PRESCRIPTION DRUG Phentermine hydrochloride Phentermine hydrochloride TABLET ORAL 20140515 ANDA ANDA040526 Northwind Pharmaceuticals PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 51655-876_d1d6b361-ba56-4c9d-875b-c4fa75323ccf 51655-876 HUMAN PRESCRIPTION DRUG Phentermine hydrochloride Phentermine hydrochloride TABLET ORAL 20140601 ANDA ANDA040377 Northwind Pharmaceuticals PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 51655-877_04e78751-69ff-4966-9af2-5ac4f21837fa 51655-877 HUMAN PRESCRIPTION DRUG Phentermine hydrochloride Phentermine hydrochloride TABLET ORAL 20140601 ANDA ANDA040555 Northwind Pharmaceuticals PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 51655-880_79cc2478-50d8-4961-beb1-1f2bcbec5d3d 51655-880 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20140428 ANDA ANDA020702 Northwind Pharmaceuticals ATORVASTATIN CALCIUM 80 mg/301 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51655-898_4ea0c6cd-58fb-39fc-e054-00144ff88e88 51655-898 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20150811 ANDA ANDA201013 Northwind Pharmaceuticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 51655-899_36e7a4c8-8353-67f0-e054-00144ff8d46c 51655-899 HUMAN PRESCRIPTION DRUG hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20150511 ANDA ANDA040655 Northwind Pharmaceuticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 51655-900_e7513186-4781-43d2-8cb9-c217ca16047e 51655-900 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen Hydrocodone Bitartate and Acetaminophen TABLET ORAL 20140601 ANDA ANDA090118 Northwind Pharmaceuticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 51655-901_82336c41-20d2-4de4-8a30-334352650bf9 51655-901 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET, FILM COATED ORAL 20150224 ANDA ANDA076635 Northwind Pharmaceuticals, LLC FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 51655-902_d7f3051c-ff67-40ab-962a-6f03e8d3a4a1 51655-902 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20150428 NDA AUTHORIZED GENERIC NDA021656 NORTHWIND PHARMACEUTICALS FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 51655-920_0118d420-2511-4801-baf4-b52a69869fbf 51655-920 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20140311 ANDA ANDA076477 Northwind Pharmaceuticals ATORVASTATIN CALCIUM 20 mg/301 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 51655-926_1937395b-5f4b-4e04-ae88-d60909220cf1 51655-926 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20140624 ANDA ANDA077877 Northwind Pharmaceuticals, LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51655-927_763fdd51-7683-4ac3-9c81-fe00be8e4e31 51655-927 HUMAN PRESCRIPTION DRUG ATENOLOL ATENOLOL TABLET ORAL 20150326 ANDA ANDA077877 Northwind Pharmaceuticals, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51655-950_67c7eee4-8622-489f-8488-452fc94b1273 51655-950 HUMAN PRESCRIPTION DRUG Valsartan HCTZ Valsartan HCTZ TABLET ORAL 20140506 ANDA ANDA091519 Northwind Pharmaceuticals VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/301; mg/301 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51655-951_8aecdef1-5dbc-42d8-adfb-aa649dfd7928 51655-951 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET ORAL 20140506 ANDA ANDA202519 Northwind Pharmaceuticals VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/301; mg/301 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51655-953_4d373996-1f9c-5336-e054-00144ff8d46c 51655-953 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160812 ANDA ANDA202519 Northwind Pharmaceuticals VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51655-955_acafa40e-1f06-427b-91e6-eddc3caf162a 51655-955 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20140506 ANDA ANDA090370 Northwind Pharmaceuticals VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 51655-956_6f42a283-b311-48d3-b2f3-cb0b45fdaabc 51655-956 HUMAN PRESCRIPTION DRUG Verapamil hydrochloride Verapamil hydrochloride TABLET, EXTENDED RELEASE ORAL 20140527 ANDA ANDA078906 Northwind Pharmaceuticals VERAPAMIL HYDROCHLORIDE 240 mg/301 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51655-964_fec9fba3-bdb3-4b61-a280-cd72ebb7fe87 51655-964 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20140617 ANDA ANDA065061 Northwind Pharmaceuticals CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 51655-979_49f0a12e-3c5b-4706-a247-f35708794fa6 51655-979 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20140527 ANDA ANDA077670 Northwind Pharmaceuticals SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51660-036_04ac9d5d-6606-4157-a71e-d5762d391ee8 51660-036 HUMAN OTC DRUG Famotidine - Acid Controller Famotidine TABLET, FILM COATED ORAL 20170531 ANDA ANDA090283 Ohm Laboratories Inc. FAMOTIDINE 20 mg/1 N 20181231 51660-070_f9de88ba-7ccc-4593-8152-dc6bdda8e759 51660-070 HUMAN OTC DRUG GUAIFENESIN Guaifenesin TABLET, EXTENDED RELEASE ORAL 20171115 NDA NDA021282 OHM LABORATORIES INC GUAIFENESIN 600 mg/1 N 20181231 51660-071_76679b03-df01-4211-9c99-d56a9b82954d 51660-071 HUMAN OTC DRUG Guaifenesin and Pseudoephedrine Hydrochloride Guaifenesin and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20171115 NDA NDA021585 OHM LABORATORIES INC GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 51660-072_e863ee96-9018-4aa6-a275-177ccd732809 51660-072 HUMAN OTC DRUG Guaifenesin Extended Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20171210 NDA NDA021282 OHM LABORATORIES INC GUAIFENESIN 1200 mg/1 N 20181231 51660-073_ac1ff91e-f2aa-43ae-aafa-5c34fc041599 51660-073 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20171210 NDA NDA021620 OHM LABORATORIES INC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 51660-123_5fc2e0e6-5e86-09ae-e053-2991aa0a9b1c 51660-123 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Ohm Laboratories Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 51660-127_cbe85544-dbbb-421c-ae7d-8d464f7a8f20 51660-127 HUMAN PRESCRIPTION DRUG NORLYROC norethindrone TABLET, FILM COATED ORAL 20140415 ANDA ANDA202260 Ohm Laboratories Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 51660-140_d8c70169-0b40-4a6f-a21a-f9d1ed75fd91 51660-140 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET, FILM COATED ORAL 20140707 ANDA ANDA077492 Ohm Laboratories Inc. VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 51660-141_d8c70169-0b40-4a6f-a21a-f9d1ed75fd91 51660-141 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET, FILM COATED ORAL 20140707 ANDA ANDA077492 Ohm Laboratories Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 51660-142_d8c70169-0b40-4a6f-a21a-f9d1ed75fd91 51660-142 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET, FILM COATED ORAL 20140707 ANDA ANDA077492 Ohm Laboratories Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 51660-143_d8c70169-0b40-4a6f-a21a-f9d1ed75fd91 51660-143 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET, FILM COATED ORAL 20140707 ANDA ANDA077492 Ohm Laboratories Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 51660-200_816c4383-e3e9-4cd3-9ab0-5789b8c9d167 51660-200 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20170612 ANDA ANDA207311 Ohm Laboratories Inc. EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 51660-204_4e98dd9f-4ab9-4d95-95b0-799ce217da70 51660-204 HUMAN OTC DRUG Pseudoephedrine hydrochloride Pseudoephedrine hydrochloride TABLET, FILM COATED ORAL 20060428 ANDA ANDA077442 Ohm Laboratories Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 51660-209_79cfee1c-0ae1-40dd-92d8-cb55dff96545 51660-209 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20090623 ANDA ANDA076134 Ohm Laboratories Inc. LORATADINE 10 mg/1 N 20181231 51660-296_9a11ba29-50ff-41ae-9d56-9f1fe98ccedd 51660-296 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 Ohm Laboratories Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 51660-333_b609a7e8-9e12-4304-94cd-b482db1d61bc 51660-333 HUMAN OTC DRUG Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Ohm Laboratories Inc. ACETAMINOPHEN 650 mg/1 N 20191231 51660-336_5e697698-a455-4ba7-a55b-4191f45c17d6 51660-336 HUMAN OTC DRUG Ohm 8 Hour Pain Reliever/Fever Reducer Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Ohm Laboratories Inc. ACETAMINOPHEN 650 mg/1 N 20181231 51660-340_94c05dc3-be35-4ff8-b57e-71fba081b91a 51660-340 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, EXTENDED RELEASE ORAL 20121221 ANDA ANDA078569 Ohm Laboratories Inc. ACETAMINOPHEN 650 mg/1 N 20181231 51660-351_6fd5c3c1-2d0e-42d0-a6f6-5cf77823fa03 51660-351 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20110628 ANDA ANDA200536 Ohm Laboratories Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 51660-352_1a199803-a059-40ce-8a16-f43cca12e38f 51660-352 HUMAN OTC DRUG Acid Reducer Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Ohm Laboratories Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 51660-423_18558918-4057-4389-b18d-0b3e73ab456d 51660-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine hydrochloride ibuprofen and pseudoephedrine hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Ohm Laboratories Inc. IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 51660-488_81825fb6-dfd8-4124-8025-8f67c37185be 51660-488 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Ohm Laboratories Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 51660-490_06452540-d883-433e-b0c5-fe2f201bc986 51660-490 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Ohm Laboratories Inc. IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 51660-491_bbe83464-a582-469f-8fac-f98e804d96fe 51660-491 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Ohm Laboratories Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 51660-492_f398ceab-e3d2-421d-813e-b66369f65472 51660-492 HUMAN OTC DRUG Pseudoephedrine hydrochloride pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Ohm Laboratories Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 51660-493_cb7fb0d3-adf6-4c14-ac61-103dc869ebf2 51660-493 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine hydrochloride ibuprofen and pseudoephedrine hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Ohm Laboratories Inc. IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 51660-526_9010a635-2b77-4932-bb93-e851e61f6cdc 51660-526 HUMAN OTC DRUG Loratadine Allergy Relief Loratadine TABLET ORAL 20171101 ANDA ANDA076134 OHM LABORATORIES INC. LORATADINE 10 mg/1 N 20191231 51660-527_c3e4b813-6989-4a31-a908-c45ee194f5ea 51660-527 HUMAN OTC DRUG Allergy Relief Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Ohm Laboratories Inc. LORATADINE 10 mg/1 N 20181231 51660-572_d017745b-0f87-42dc-9d2c-be8ad495e953 51660-572 HUMAN PRESCRIPTION DRUG Delyla Levonorgestrel and Ethinyl Estradiol KIT 20140526 ANDA ANDA201108 OHM LABORATORIES INC. E 20171231 51660-724_40f5bbd1-776e-45b7-8a29-91bd930cec2c 51660-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Ohm Laboratories Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 51660-904_623aa8f4-d84d-4dae-9fcb-51e2b288d52a 51660-904 HUMAN PRESCRIPTION DRUG VALACYCLOVIR VALACYCLOVIR HYDROCHLORIDE TABLET ORAL 20091125 ANDA ANDA076588 Ohm Laboratories Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 51660-905_623aa8f4-d84d-4dae-9fcb-51e2b288d52a 51660-905 HUMAN PRESCRIPTION DRUG VALACYCLOVIR VALACYCLOVIR HYDROCHLORIDE TABLET ORAL 20091125 ANDA ANDA076588 Ohm Laboratories Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 51660-939_84fefe79-0573-440b-bf2e-c836a616e2e3 51660-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Ohm Laboratories Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 51668-201_8c6a2916-71df-4f0c-84b1-cda0260f44a6 51668-201 HUMAN OTC DRUG Koh Gen Do Maifanshi UV Face Powder titanium dioxide POWDER TOPICAL 20110825 OTC MONOGRAPH NOT FINAL part352 Koh Gen Do USA, Inc TITANIUM DIOXIDE .9558 g/12g E 20171231 51670-100_2086586e-b29a-42dd-b191-7bd7f61caa99 51670-100 HUMAN OTC DRUG RECURO VAGINAL POVIDONE IODINE DOUCHE VAGINAL 20101025 OTC MONOGRAPH NOT FINAL part333E IONA PHARMACY POVIDONE-IODINE .3 mL/100mL E 20171231 51672-1253_3680252c-a334-4c57-b58f-997c28ccba57 51672-1253 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 NDA NDA019117 Taro Pharmaceuticals U.S.A., Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1254_3680252c-a334-4c57-b58f-997c28ccba57 51672-1254 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19890119 ANDA ANDA072494 Taro Pharmaceuticals U.S.A., Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1258_069f388e-a8d0-4e58-b357-4e8c3e54d8b4 51672-1258 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 19960708 ANDA ANDA074249 Taro Pharmaceuticals U.S.A., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1259_069f388e-a8d0-4e58-b357-4e8c3e54d8b4 51672-1259 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 19960712 ANDA ANDA074248 Taro Pharmaceuticals U.S.A., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1260_c36fc08c-8853-421c-9b84-96a67c04ea34 51672-1260 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole SOLUTION TOPICAL 19960729 ANDA ANDA074580 Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 51672-1261_f033149e-70e4-4765-aa06-4a28507d4433 51672-1261 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone GEL TOPICAL 19980714 ANDA ANDA074904 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1262_7751daa3-9f47-4c47-8235-2978e6ff30ef 51672-1262 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 19960607 ANDA ANDA074286 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1263_b273a20b-15c8-4bf3-b68b-f776516281f6 51672-1263 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364 Taro Pharmaceuticals U.S.A., Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1264_3680252c-a334-4c57-b58f-997c28ccba57 51672-1264 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 19990630 ANDA ANDA075008 Taro Pharmaceuticals U.S.A., Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1267_e24f57f1-b0f8-449e-b34e-348a80de71b7 51672-1267 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE DENTAL 19861001 ANDA ANDA070730 Taro Pharmaceuticals U.S.A., Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1269_26f72658-a9d0-44a4-ae37-b9df4cebd0e6 51672-1269 HUMAN PRESCRIPTION DRUG BETAMETHASONE VALERATE Betamethasone Valerate CREAM TOPICAL 19880106 ANDA ANDA072041 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1270_f033149e-70e4-4765-aa06-4a28507d4433 51672-1270 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 19901130 ANDA ANDA073193 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1271_f033149e-70e4-4765-aa06-4a28507d4433 51672-1271 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 19901130 ANDA ANDA073210 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1272_b273a20b-15c8-4bf3-b68b-f776516281f6 51672-1272 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide OINTMENT TOPICAL 19930329 ANDA ANDA063305 Taro Pharmaceuticals U.S.A., Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1273_fc6bd5c7-c357-4aaf-a863-8fc78bdc04c8 51672-1273 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide SOLUTION TOPICAL 19961231 ANDA ANDA074799 Taro Pharmaceuticals U.S.A., Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1274_4531f9df-12a0-43c8-b733-ba6109322703 51672-1274 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19920430 ANDA ANDA073552 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE DIPROPIONATE .64 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1275_0efe7db5-860b-4e4e-bfc1-27ef85f0c6b2 51672-1275 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19930831 ANDA ANDA072640 Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 51672-1279_3680252c-a334-4c57-b58f-997c28ccba57 51672-1279 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide GEL TOPICAL 19970729 ANDA ANDA074935 Taro Pharmaceuticals U.S.A., Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1280_56c13983-3bd8-46eb-949e-5255cf355265 51672-1280 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 19920630 ANDA ANDA073548 Taro Pharmaceuticals U.S.A., Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1281_56c13983-3bd8-46eb-949e-5255cf355265 51672-1281 HUMAN PRESCRIPTION DRUG Desonide Desonide OINTMENT TOPICAL 19940803 ANDA ANDA074254 Taro Pharmaceuticals U.S.A., Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1282_0e314bbe-0260-4a62-a9ef-c54c221fc09d 51672-1282 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19971126 ANDA ANDA040039 Taro Pharmaceuticals U.S.A., Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1284_0eff3f9b-a7a4-4a98-9ba4-c4f1cd3d35c9 51672-1284 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 19940930 ANDA ANDA040037 Taro Pharmaceuticals U.S.A., Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1289_886fd5e0-e2dc-4891-b16c-8b741d58a95c 51672-1289 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 19930128 ANDA ANDA064022 Taro Pharmaceuticals U.S.A., Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 51672-1290_14b91917-4c7e-4293-9ede-cad079cc10ff 51672-1290 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate CREAM TOPICAL 19980825 ANDA ANDA075042 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1292_14b91917-4c7e-4293-9ede-cad079cc10ff 51672-1292 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate OINTMENT TOPICAL 19980825 ANDA ANDA075043 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1293_c87adfc9-9c84-40bd-8896-a7dcb6a324e5 51672-1293 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate SOLUTION TOPICAL 19981116 ANDA ANDA075224 Taro Pharmaceuticals U.S.A., Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1294_069f388e-a8d0-4e58-b357-4e8c3e54d8b4 51672-1294 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate GEL TOPICAL 19990528 ANDA ANDA075279 Taro Pharmaceuticals U.S.A., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1295_86a46c74-e692-463f-884b-5d29900a7def 51672-1295 HUMAN PRESCRIPTION DRUG Diflorasone Diacetate Diflorasone Diacetate OINTMENT TOPICAL 19990514 ANDA ANDA075331 Taro Pharmaceuticals U.S.A., Inc. DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1296_83cbe224-aac0-4b38-9937-dbd3fe69febf 51672-1296 HUMAN PRESCRIPTION DRUG Diflorasone Diacetate Diflorasone Diacetate CREAM TOPICAL 20000424 ANDA ANDA075508 Taro Pharmaceuticals U.S.A., Inc. DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1297_ba80f39a-ddc8-4338-ae41-e617bb142d2f 51672-1297 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20000517 ANDA ANDA075633 Taro Pharmaceuticals U.S.A., Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1298_146e8ac5-b879-4b84-9e3f-f3b1748965dd 51672-1298 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 Taro Pharmaceuticals U.S.A., Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51672-1300_b2dec930-0ae6-4f5d-b143-1b9a6f32cc35 51672-1300 HUMAN PRESCRIPTION DRUG Ammonium Lactate Ammonium Lactate LOTION TOPICAL 20040528 ANDA ANDA076216 Taro Pharmaceuticals U.S.A., Inc. AMMONIUM LACTATE 120 mg/g N 20181231 51672-1301_2f3dba1a-b41e-493a-9a57-cd89fb9d71ab 51672-1301 HUMAN PRESCRIPTION DRUG Ammonium Lactate Ammonium Lactate CREAM TOPICAL 20030410 ANDA ANDA075883 Taro Pharmaceuticals U.S.A., Inc. AMMONIUM LACTATE 120 mg/g N 20181231 51672-1302_f13ccf7d-4dd8-4f84-bdd9-8cef11a64b44 51672-1302 HUMAN PRESCRIPTION DRUG Terconazole Terconazole CREAM VAGINAL 20040406 ANDA ANDA075953 Taro Pharmaceuticals U.S.A., Inc. TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 51672-1303_9dc8b1b1-f749-4bc7-a34f-6f4383f71499 51672-1303 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20021126 ANDA ANDA076005 Taro Pharmaceuticals U.S.A., Inc. ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 51672-1304_817901ff-27c6-4cf9-8550-a950d033b91c 51672-1304 HUMAN PRESCRIPTION DRUG Terconazole Terconazole CREAM VAGINAL 20050119 ANDA ANDA076043 Taro Pharmaceuticals U.S.A., Inc. TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 51672-1305_42368b48-0811-468b-a9b6-6a9cafb39e28 51672-1305 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate SOLUTION TOPICAL 20060315 ANDA ANDA076788 Taro Pharmaceuticals U.S.A., Inc. MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1306_5258b899-9a64-4224-a834-2a5e38007126 51672-1306 HUMAN PRESCRIPTION DRUG Alclometasone dipropionate Alclometasone dipropionate CREAM TOPICAL 20050915 ANDA ANDA076587 Taro Pharmaceuticals U.S.A., Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1308_1003cd3d-c3d2-433b-82a1-03844326188d 51672-1308 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate LOTION TOPICAL 20040728 ANDA ANDA076493 Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/mL; mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1309_b01780b5-c25d-4999-8380-ef352e47aec0 51672-1309 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate GEL TOPICAL 20031202 ANDA ANDA076508 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1310_ea4a3365-7663-4259-b3e2-4e9af2238767 51672-1310 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM, AUGMENTED TOPICAL 20031209 ANDA ANDA076543 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1311_76136422-cd2b-4bbd-913e-e1359af86a97 51672-1311 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20041203 ANDA ANDA076624 Taro Pharmaceuticals U.S.A., Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1312_59cdfa23-d6e6-4c98-ab88-e76de0a5da4e 51672-1312 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20050923 ANDA ANDA065170 Taro Pharmaceuticals U.S.A., Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 51672-1315_e2e3844d-11ea-4c1c-a025-851f58a121dc 51672-1315 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20041221 ANDA ANDA076679 Taro Pharmaceuticals U.S.A., Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1316_4f474a39-2f6e-4ade-818d-f626a04f51e2 51672-1316 HUMAN PRESCRIPTION DRUG Alclometasone Dipropionate Alclometasone dipropionate OINTMENT TOPICAL 20040729 ANDA ANDA076730 Taro Pharmaceuticals U.S.A., Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1317_8430e050-1656-4316-b3fc-4cf2ed9ba1be 51672-1317 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT, AUGMENTED TOPICAL 20041012 ANDA ANDA076753 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1318_93dfcb34-d3a0-4296-ad79-bc911a7a8082 51672-1318 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine ciclopirox olamine CREAM TOPICAL 20050412 ANDA ANDA076790 Taro Pharmaceuticals U.S.A., Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 51672-1321_bf6fd425-06da-4684-80ff-d75bc6f0947c 51672-1321 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate CREAM TOPICAL 20050804 ANDA ANDA077227 Taro Pharmaceuticals U.S.A., Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1322_6685d3da-5148-4113-b65f-96ff9f20fdec 51672-1322 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate OINTMENT TOPICAL 20041216 ANDA ANDA076994 Taro Pharmaceuticals U.S.A., Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1323_055fcd4a-e5a2-4856-a9e1-e6dd2b22d28e 51672-1323 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SUSPENSION TOPICAL 20050810 ANDA ANDA077092 Taro Pharmaceuticals U.S.A., Inc. CICLOPIROX OLAMINE 7.7 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 51672-1326_a9ea50e1-ec17-4342-80f5-7bc6d7bc8cb9 51672-1326 HUMAN PRESCRIPTION DRUG Lustra Hydroquinone CREAM TOPICAL 20050120 UNAPPROVED DRUG OTHER Taro Pharmaceuticals U.S.A., Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 51672-1327_a9ea50e1-ec17-4342-80f5-7bc6d7bc8cb9 51672-1327 HUMAN PRESCRIPTION DRUG Lustra-AF Hydroquinone CREAM TOPICAL 20050120 UNAPPROVED DRUG OTHER Taro Pharmaceuticals U.S.A., Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 51672-1330_d4c3cb7a-21be-4d8e-a20c-90018539260b 51672-1330 HUMAN PRESCRIPTION DRUG Terconazole Terconazole SUPPOSITORY VAGINAL 20070309 ANDA ANDA077553 Taro Pharmaceuticals U.S.A., Inc. TERCONAZOLE 80 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 51672-1335_722c00c5-bd11-4d3d-8ad2-39b38b85cdd0 51672-1335 HUMAN PRESCRIPTION DRUG Oralone Triamcinolone Acetonide PASTE DENTAL 19861001 ANDA ANDA070730 Taro Pharmaceuticals U.S.A., Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1338_21f9746f-6e25-41c9-ba6c-6040913ea5c7 51672-1338 HUMAN PRESCRIPTION DRUG Flo-Pred Prednisolone Acetate SUSPENSION ORAL 20080117 NDA NDA022067 Taro Pharmaceuticals U.S.A., Inc. PREDNISOLONE ACETATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1340_ee3aff58-f02e-4279-b432-467c9a845859 51672-1340 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate LOTION, AUGMENTED TOPICAL 20070521 ANDA ANDA077477 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE DIPROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1346_ebca51fc-bda6-4932-8c37-4fd5e70dab5b 51672-1346 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SUSPENSION TOPICAL 20090520 ANDA ANDA078668 Taro Pharmaceuticals U.S.A., Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 51672-1348_f6b14a85-d828-47f1-8a0a-b4e1c10f3894 51672-1348 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate SOLUTION ORAL 20120503 ANDA ANDA079121 Taro Pharmaceuticals U.S.A., Inc. ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51672-1349_5fd8fa46-5b79-4c23-b694-f6e4481e60d2 51672-1349 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20110207 ANDA ANDA090347 Taro Pharmaceuticals U.S.A., Inc. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 51672-1350_f8b41cc3-265f-48b4-8055-6338fa6faa68 51672-1350 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate LOTION TOPICAL 20120702 ANDA ANDA200302 Taro Pharmaceuticals U.S.A., Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1351_3f7df0b3-078b-4fe4-ad67-c3fede8d36dd 51672-1351 HUMAN PRESCRIPTION DRUG Ciclopirox ciclopirox SHAMPOO TOPICAL 20110223 ANDA ANDA090269 Taro Pharmaceuticals U.S.A., Inc. CICLOPIROX 10 mg/.96mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 51672-1352_1b5da4d5-cba3-43c9-9254-419ffc90691e 51672-1352 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 19850117 NDA NDA018594 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1353_4730a056-e119-4a46-966c-8647dbb6ae38 51672-1353 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140714 ANDA ANDA200734 Taro Pharmaceuticals U.S.A., Inc. FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1356_b0c6364b-bb3d-4c34-9b51-112d3ea8af3e 51672-1356 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20160519 ANDA ANDA202368 Taro Pharmaceuticals U.S.A., Inc. FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1357_242a9844-214b-4e4c-8a25-ba4d1f2c3bc5 51672-1357 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20160519 ANDA ANDA209336 Taro Pharmaceuticals U.S.A., Inc. FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1358_fc1f418d-ac6c-4c32-91ad-9c339294591a 51672-1358 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20141126 ANDA ANDA203818 Taro Pharmaceuticals U.S.A., Inc. DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51672-1359_18b61af9-a976-4d21-ab43-6d424eb32cbb 51672-1359 HUMAN PRESCRIPTION DRUG Oxiconazole Nitrate Oxiconazole Nitrate CREAM TOPICAL 20160307 ANDA ANDA205076 Taro Pharmaceuticals U.S.A., Inc. OXICONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 51672-1360_318fdb7d-10d9-49cf-bbd1-0a7480b962d9 51672-1360 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir OINTMENT TOPICAL 20161221 ANDA ANDA205469 Taro Pharmaceuticals U.S.A., Inc. ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 51672-1362_e251d16a-efe7-4da8-840d-f524d0c228e8 51672-1362 HUMAN PRESCRIPTION DRUG Naftifine Hydrochloride Naftifine Hydrochloride CREAM TOPICAL 20160908 ANDA ANDA205975 Taro Pharmaceuticals U.S.A., Inc. NAFTIFINE HYDROCHLORIDE 10 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 51672-1363_91bec6ef-621a-49ab-8186-74f78dc9256d 51672-1363 HUMAN PRESCRIPTION DRUG Diclofenac sodium diclofenac sodium GEL TOPICAL 20160428 ANDA ANDA206298 Taro Pharmaceuticals U.S.A., Inc. DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51672-1364_c8d13d7d-b67b-46c2-a56b-8a95c6f2f92b 51672-1364 HUMAN PRESCRIPTION DRUG ADAPALENE and BENZOYL PEROXIDE ADAPALENE and BENZOYL PEROXIDE GEL TOPICAL 20180124 ANDA ANDA206959 Taro Pharmaceuticals U.S.A., Inc. ADAPALENE; BENZOYL PEROXIDE 1; 25 mg/g; mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20191231 51672-1365_da8607e3-0065-4646-a45d-a18b044bde21 51672-1365 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide SOLUTION TOPICAL 20150327 ANDA ANDA089124 Taro Pharmaceuticals U.S.A., Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1366_6fb5809a-544f-4a30-81d9-09ba2396a252 51672-1366 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl Peroxide GEL TOPICAL 20171215 ANDA ANDA206218 Taro Pharmaceuticals U.S.A., Inc. CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE 10; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 51672-1368_141e86d6-f1c3-42bd-bde7-8cd65e4a955a 51672-1368 HUMAN PRESCRIPTION DRUG Naftifine Hydrochloride Naftifine Hydrochloride CREAM TOPICAL 20160106 ANDA ANDA206901 Taro Pharmaceuticals U.S.A., Inc. NAFTIFINE HYDROCHLORIDE 20 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 51672-1373_423e1f72-7ad6-4982-946d-197cb19a3b22 51672-1373 HUMAN PRESCRIPTION DRUG Tazarotene Tazarotene CREAM TOPICAL 20170403 ANDA ANDA208258 Taro Pharmaceuticals U.S.A., Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 51672-1374_e8ef4870-6351-4567-adb4-b8a8778183ad 51672-1374 HUMAN PRESCRIPTION DRUG Tazarotene Tazarotene CREAM TOPICAL 20170403 ANDA ANDA208258 Taro Pharmaceuticals U.S.A., Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 51672-1377_cebb9934-766b-416a-93b2-aa41693c5615 51672-1377 HUMAN PRESCRIPTION DRUG Adapalene Adapalene GEL TOPICAL 20160623 ANDA ANDA208322 Taro Pharmaceuticals U.S.A., Inc. ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 51672-1385_2f220a13-03e9-4af1-a88a-90bf261cf42a 51672-1385 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20170623 ANDA ANDA209204 Taro Pharmaceuticals U.S.A., Inc. IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51672-1386_3bf60a1f-44db-449f-be34-7e6147138c2b 51672-1386 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20161027 ANDA ANDA071500 Taro Pharmaceuticals U.S.A., inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-1387_3a9a1780-9004-41b6-bf7a-70567b663b9f 51672-1387 HUMAN PRESCRIPTION DRUG Dapsone Dapsone GEL TOPICAL 20171016 ANDA ANDA209506 Taro Pharmaceuticals U.S.A., Inc. DAPSONE 50 mg/g Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 51672-2001_a1afea8d-75d9-4662-a6a4-5c76f271dffc 51672-2001 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM TOPICAL 19911001 OTC MONOGRAPH FINAL part333C Taro Pharmaceuticals U.S.A., Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 51672-2002_8a00e8c7-8ea8-4472-a27f-feca95647963 51672-2002 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE 1 g/100g N 20181231 51672-2003_4e88541b-69a2-4c9d-8aca-0e053a646015 51672-2003 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 19951204 ANDA ANDA072641 Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE 1 g/100g N 20181231 51672-2010_90beeb88-6729-42c9-a0ec-57a7ee196731 51672-2010 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20010913 OTC MONOGRAPH NOT FINAL part348 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE .5 g/100g N 20181231 51672-2013_a7ccc7ea-73a2-4bed-8766-77607f6a9fbd 51672-2013 HUMAN OTC DRUG Hydrocortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Taro Phamaceuticals U.S.A., Inc. HYDROCORTISONE 1 g/100g N 20181231 51672-2016_6f31e99b-27f3-4d3a-94eb-f749e635986f 51672-2016 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Taro Pharmaceuticals U.S.A., Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 51672-2018_ba64fa57-7065-49ff-a131-9155170cb494 51672-2018 HUMAN OTC DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE 1 g/100g N 20181231 51672-2020_a9e3bbbc-2713-4fc8-9c14-70e823b6902a 51672-2020 HUMAN OTC DRUG Tolnaftate Antifungal Tolnaftate CREAM TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Taro Pharmaceuticals U.S.A., Inc. TOLNAFTATE 1 g/100g N 20181231 51672-2027_2507eb8e-f42a-4ae7-b1d9-3aea988623f4 51672-2027 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Taro Pharmaceuticals U.S.A., Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 51672-2030_129838bb-ece0-48f1-80ce-c3adf7f0ea13 51672-2030 HUMAN OTC DRUG Oxymetazoline Hydrochloride 12-Hour Oxymetazoline Hydrochloride SPRAY NASAL 20060225 OTC MONOGRAPH FINAL part341 Taro Pharmaceuticals U.S.A., Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 51672-2035_9a378ad1-5196-48b8-b446-e33f53e3b28f 51672-2035 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM VAGINAL 19970113 ANDA ANDA074444 Taro Pharmaceuticals U.S.A., Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 51672-2037_b45ed188-20d9-4de5-8f52-0f57cfe2bf11 51672-2037 HUMAN OTC DRUG Clotrimazole Clotrimazole SOLUTION TOPICAL 19960501 OTC MONOGRAPH FINAL part333C Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE 1 g/mL N 20181231 51672-2062_708f18d8-30c5-40df-8972-28a3703753fc 51672-2062 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE 2 g/100g N 20181231 51672-2063_28fde66d-7dff-4817-a35b-76cf135485a7 51672-2063 HUMAN OTC DRUG Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE 1 g/100g N 20181231 51672-2069_86cf0f9a-43b3-4f0a-b9b2-b82495d95b58 51672-2069 HUMAN OTC DRUG Hydrocortisone Acetate Antipruritic (Anti-Itch) Hydrocortisone Acetate CREAM TOPICAL 20010601 OTC MONOGRAPH NOT FINAL part348 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE ACETATE 1 g/100g N 20181231 51672-2070_bedd3c8e-ead8-4e1e-8afb-481a8fa37aa0 51672-2070 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Taro Pharmaceuticals U.S.A., Inc. MICONAZOLE NITRATE 40 mg/g N 20181231 51672-2073_89775f9d-202c-4895-8380-f3d63100d021 51672-2073 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Taro Pharmaceuticals U.S.A., Inc. LORATADINE 5 mg/5mL N 20181231 51672-2075_c1164186-f21c-4b67-9dea-6561a8753970 51672-2075 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Taro Pharmaceuticals U.S.A., Inc. BACITRACIN ZINC 500 [USP'U]/g N 20181231 51672-2080_8440d9a3-c2bd-462e-98b2-74faa0818949 51672-2080 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Taro Pharmaceuticals U.S.A., Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 51672-2085_d7344c42-6a5f-4f30-bfb9-4c5724e47c24 51672-2085 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Taro Pharmaceuticals U.S.A., Inc. LORATADINE 5 mg/5mL N 20181231 51672-2088_b143fc4b-485d-4dfb-9dfe-b3f5227666ec 51672-2088 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Taro Pharmaceuticals U.S.A., Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 51672-2089_66a9522f-5353-4681-9895-bfc3b6512a77 51672-2089 HUMAN OTC DRUG Diphenhydramine Hydrochloride and Zinc Acetate Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20050920 OTC MONOGRAPH NOT FINAL part348 Taro Pharmaceuticals U.S.A., Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 51672-2092_cfa1f46a-db8c-40f5-b9c1-3bbcb4ba3a9e 51672-2092 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Taro Pharmaceuticals U.S.A., Inc. LORATADINE 5 mg/5mL N 20181231 51672-2097_e9d6516f-a2d1-4746-81ce-2eb3172c7906 51672-2097 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20090722 ANDA ANDA078072 Taro Pharmaceuticals U.S.A., Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 51672-2100_2c67420b-73a6-4382-bc58-fc031ac3e6af 51672-2100 HUMAN OTC DRUG Athletes Foot Butenafine Hydrochloride CREAM TOPICAL 20171117 ANDA ANDA205181 Taro Pharmaceuticals U.S.A., inc. BUTENAFINE HYDROCHLORIDE 10 mg/g N 20181231 51672-2101_a0159f92-c609-486b-a727-bc4d431ed8eb 51672-2101 HUMAN OTC DRUG Jock Itch Butenafine Hydrochloride CREAM TOPICAL 20171117 ANDA ANDA205181 Taro Pharmaceuticals U.S.A., inc. BUTENAFINE HYDROCHLORIDE 10 mg/g N 20181231 51672-2102_b0198728-004d-4ba1-8f23-a0d4aec132ef 51672-2102 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Sugar Free Grape Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Taro Pharmaceuticals U.S.A., Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 51672-2106_2e366c22-a759-42c0-8fc3-2ad42114ee06 51672-2106 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Taro Pharmaceuticals U.S.A., Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 51672-2108_205501ab-ba89-486b-a297-818a0215edfa 51672-2108 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20161208 ANDA ANDA201865 Taro Pharmaceuticals U.S.A., Inc. LORATADINE 5 mg/5mL N 20181231 51672-2112_6e7d4f42-d756-4787-8b8a-13d40b0692a2 51672-2112 HUMAN OTC DRUG Daytime Flu and Severe Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Taro Pharmaceuticals U.S.A., Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 51672-2113_d95641a2-6c74-4fdf-bdac-77773a41f921 51672-2113 HUMAN OTC DRUG Nighttime Flu and Severe Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20130628 OTC MONOGRAPH FINAL part341 Taro Pharmaceuticals U.S.A. Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 51672-2114_c9225506-0601-434e-b615-daf0862c549f 51672-2114 HUMAN OTC DRUG Feverall Infants Acetaminophen SUPPOSITORY RECTAL 20131212 NDA NDA018337 Taro Pharmaceuticals U.S.A. Inc. ACETAMINOPHEN 80 mg/1 N 20181231 51672-2115_dfd8f168-c6bc-4bf8-8bf1-8be7b27b68df 51672-2115 HUMAN OTC DRUG Feverall Childrens Acetaminophen SUPPOSITORY RECTAL 20131212 NDA NDA018337 Taro Pharmaceuticals U.S.A. Inc. ACETAMINOPHEN 120 mg/1 N 20181231 51672-2116_52c671f6-0ea3-4f71-a897-309a1a01cce7 51672-2116 HUMAN OTC DRUG Feverall Jr. Strength Acetaminophen SUPPOSITORY RECTAL 20131212 NDA NDA018337 Taro Pharmaceuticals U.S.A. Inc. ACETAMINOPHEN 325 mg/1 N 20181231 51672-2117_c107ee4d-6fd8-4cd8-9f80-5d140801eaba 51672-2117 HUMAN OTC DRUG Feverall Adults Acetaminophen SUPPOSITORY RECTAL 20131212 NDA NDA018337 Taro Pharmaceuticals U.S.A. Inc. ACETAMINOPHEN 650 mg/1 N 20181231 51672-2119_2d6e0c2a-2637-4953-815d-3ffc22fbf9c3 51672-2119 HUMAN OTC DRUG Childrens Fexofenadine Hydrochloride Allergy Fexofenadine Hydrochloride SUSPENSION ORAL 20171109 ANDA ANDA208123 Taro Pharmaceuticals U.S.A., Inc. FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 51672-2120_15ca58e8-88b6-43ed-9529-92c07eda6a25 51672-2120 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20151215 OTC MONOGRAPH FINAL part333B Taro Pharmaceuticals U.S.A., Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 51672-2121_d43ceeee-a210-45ca-a204-57c465c4e15c 51672-2121 HUMAN OTC DRUG Childrens Fexofenadine Hydrochloride HIVES Fexofenadine Hydrochloride SUSPENSION ORAL 20171109 ANDA ANDA208123 Taro Pharmaceuticals U.S.A., Inc. FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 51672-2130_a525d8f6-4aa3-43fe-a5ea-8594e21ade52 51672-2130 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20170627 ANDA ANDA209207 Taro Pharmaceuticals U.S.A., Inc. IBUPROFEN 100 mg/5mL N 20181231 51672-2131_c1ef6b79-a5cb-410c-9be9-0d798e1c33ce 51672-2131 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Taro Pharmaceuticals U.S.A., Inc. LORATADINE 5 mg/5mL N 20181231 51672-3003_81c2ec5a-0180-4682-ae52-876a23818557 51672-3003 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20050428 ANDA ANDA088799 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-3004_81c2ec5a-0180-4682-ae52-876a23818557 51672-3004 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20050428 ANDA ANDA086155 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-3007_1885daca-1292-47cb-bbd8-cf65dbc5e507 51672-3007 HUMAN PRESCRIPTION DRUG Hydrocortisone and Acetic Acid Hydrocortisone and Acetic Acid SOLUTION AURICULAR (OTIC) 20050428 ANDA ANDA088759 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE; ACETIC ACID 10.4; 20.8 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-3008_89801fac-0f3d-429f-b7d4-44d5a6cc92fb 51672-3008 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 19810817 ANDA ANDA086724 Taro Pharmaceuticals U.S.A., Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 51672-3009_e10a8fdf-4273-4083-864d-28fe6535c9a6 51672-3009 HUMAN PRESCRIPTION DRUG U-Cort Hydrocortisone Acetate CREAM TOPICAL 19880613 ANDA ANDA089472 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE ACETATE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-3020_d5459d0c-43f3-4210-ab45-4c0c73290470 51672-3020 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20130325 ANDA ANDA086724 Taro Pharmaceuticals U.S.A., Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 51672-4001_5652bcc2-39cf-4313-a8bc-08d6cf1693c5 51672-4001 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Taro Pharmaceuticals U.S.A., Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51672-4002_5652bcc2-39cf-4313-a8bc-08d6cf1693c5 51672-4002 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Taro Pharmaceuticals U.S.A., Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51672-4003_5652bcc2-39cf-4313-a8bc-08d6cf1693c5 51672-4003 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Taro Pharmaceuticals U.S.A., Inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51672-4004_5652bcc2-39cf-4313-a8bc-08d6cf1693c5 51672-4004 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Taro Pharmaceuticals U.S.A., Inc. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51672-4005_54781e7a-02ee-426b-845f-d6d71d8bb6e0 51672-4005 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 51672-4011_f850828c-b3f3-43c7-a8fa-0454932f9925 51672-4011 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Taro Pharmaceuticals U.S.A., Inc. CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51672-4012_f850828c-b3f3-43c7-a8fa-0454932f9925 51672-4012 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Taro Pharmaceuticals U.S.A., Inc. CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51672-4013_f850828c-b3f3-43c7-a8fa-0454932f9925 51672-4013 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Taro Pharmaceuticals U.S.A., Inc. CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51672-4016_f4440ea0-5ba7-492c-af23-fe8c97fdbe58 51672-4016 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980430 ANDA ANDA075078 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51672-4017_f4440ea0-5ba7-492c-af23-fe8c97fdbe58 51672-4017 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980430 ANDA ANDA075078 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51672-4018_f4440ea0-5ba7-492c-af23-fe8c97fdbe58 51672-4018 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51672-4022_e379abc1-3c52-4a1f-a53f-628f6454e22c 51672-4022 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528 ANDA ANDA040195 Taro Pharmaceuticals U.S.A., Inc. ACETAZOLAMIDE 125 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 51672-4023_e379abc1-3c52-4a1f-a53f-628f6454e22c 51672-4023 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528 ANDA ANDA040195 Taro Pharmaceuticals U.S.A., Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 51672-4025_d602d0a0-d62c-4996-beae-ec7489f312ff 51672-4025 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20010330 ANDA ANDA075424 Taro Pharmaceuticals U.S.A., Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 51672-4026_d286450c-077f-442d-a53f-7276cfb3c388 51672-4026 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075319 Taro Pharmaceuticals U.S.A., Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51672-4027_4e72832d-fbd7-4bf3-946c-6aeec550d345 51672-4027 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 51672-4028_4e72832d-fbd7-4bf3-946c-6aeec550d345 51672-4028 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 51672-4029_4e72832d-fbd7-4bf3-946c-6aeec550d345 51672-4029 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 51672-4030_4e72832d-fbd7-4bf3-946c-6aeec550d345 51672-4030 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 51672-4031_4e72832d-fbd7-4bf3-946c-6aeec550d345 51672-4031 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 51672-4032_4e72832d-fbd7-4bf3-946c-6aeec550d345 51672-4032 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 51672-4033_4e72832d-fbd7-4bf3-946c-6aeec550d345 51672-4033 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 51672-4034_4e72832d-fbd7-4bf3-946c-6aeec550d345 51672-4034 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 51672-4035_4e72832d-fbd7-4bf3-946c-6aeec550d345 51672-4035 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Taro Pharmaceuticals U.S.A., Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 51672-4036_f4440ea0-5ba7-492c-af23-fe8c97fdbe58 51672-4036 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20000425 ANDA ANDA075074 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51672-4037_763dc954-e26f-411e-95df-e8ec939f915f 51672-4037 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51672-4038_763dc954-e26f-411e-95df-e8ec939f915f 51672-4038 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51672-4039_763dc954-e26f-411e-95df-e8ec939f915f 51672-4039 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51672-4040_763dc954-e26f-411e-95df-e8ec939f915f 51672-4040 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 51672-4041_54781e7a-02ee-426b-845f-d6d71d8bb6e0 51672-4041 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 20001024 ANDA ANDA075687 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 51672-4042_032414be-07b6-4ba9-8150-be7056140715 51672-4042 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Taro Pharmaceuticals U.S.A., Inc. CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51672-4043_032414be-07b6-4ba9-8150-be7056140715 51672-4043 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Taro Pharmaceuticals U.S.A., Inc. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51672-4044_032414be-07b6-4ba9-8150-be7056140715 51672-4044 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Taro Pharmaceuticals U.S.A., Inc. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51672-4045_e8d729a3-ecb4-47db-b033-fcb329d20032 51672-4045 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20010918 ANDA ANDA075788 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51672-4046_e8d729a3-ecb4-47db-b033-fcb329d20032 51672-4046 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20010918 ANDA ANDA075788 Taro Pharmaceuticals U.S.A., Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 51672-4047_54781e7a-02ee-426b-845f-d6d71d8bb6e0 51672-4047 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine SUSPENSION ORAL 20040920 ANDA ANDA076729 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 100 mg/5mL Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 51672-4048_740d2537-071d-4871-aea6-ea96f83ebac4 51672-4048 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20010529 ANDA ANDA075673 Taro Pharmaceuticals U.S.A., Inc. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-4051_f66f8757-621d-47b2-83ab-947bab15d1be 51672-4051 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51672-4052_f66f8757-621d-47b2-83ab-947bab15d1be 51672-4052 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51672-4053_f66f8757-621d-47b2-83ab-947bab15d1be 51672-4053 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Taro Pharmaceuticals U.S.A., Inc. ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51672-4054_33e00bbf-103a-4df9-b31b-4cd711916f59 51672-4054 HUMAN PRESCRIPTION DRUG Amcinonide Amcinonide CREAM TOPICAL 20020531 ANDA ANDA076229 Taro Pharmaceuticals U.S.A., Inc. AMCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-4055_d602d0a0-d62c-4996-beae-ec7489f312ff 51672-4055 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20010330 ANDA ANDA075424 Taro Pharmaceuticals U.S.A., Inc. AMIODARONE HYDROCHLORIDE 100 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 51672-4056_d602d0a0-d62c-4996-beae-ec7489f312ff 51672-4056 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20031202 ANDA ANDA076362 Taro Pharmaceuticals U.S.A., Inc. AMIODARONE HYDROCHLORIDE 300 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 51672-4057_d602d0a0-d62c-4996-beae-ec7489f312ff 51672-4057 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20021129 ANDA ANDA076362 Taro Pharmaceuticals U.S.A., Inc. AMIODARONE HYDROCHLORIDE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 51672-4060_33e00bbf-103a-4df9-b31b-4cd711916f59 51672-4060 HUMAN PRESCRIPTION DRUG Amcinonide Amcinonide OINTMENT TOPICAL 20030319 ANDA ANDA076367 Taro Pharmaceuticals U.S.A., Inc. AMCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-4061_49209aac-2b24-4c2b-b146-3f66b60a499e 51672-4061 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate Hydrocortisone Butyrate SOLUTION TOPICAL 20040114 ANDA ANDA076364 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE BUTYRATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-4062_768f2866-96ff-434c-abfc-1233c9de043e 51672-4062 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil SOLUTION TOPICAL 20031105 ANDA ANDA076526 Taro Pharmaceuticals U.S.A., Inc. FLUOROURACIL 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 51672-4063_768f2866-96ff-434c-abfc-1233c9de043e 51672-4063 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil SOLUTION TOPICAL 20031105 ANDA ANDA076526 Taro Pharmaceuticals U.S.A., Inc. FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 51672-4064_26bb75df-5468-42bb-bdc7-2b01af437e0a 51672-4064 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076507 Taro Pharmaceuticals U.S.A., Inc. FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 51672-4065_26bb75df-5468-42bb-bdc7-2b01af437e0a 51672-4065 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076507 Taro Pharmaceuticals U.S.A., Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 51672-4066_26bb75df-5468-42bb-bdc7-2b01af437e0a 51672-4066 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076507 Taro Pharmaceuticals U.S.A., Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 51672-4067_26bb75df-5468-42bb-bdc7-2b01af437e0a 51672-4067 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076507 Taro Pharmaceuticals U.S.A., Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 51672-4069_e9b35318-a3d0-4499-ba26-b2b417c0e672 51672-4069 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20040408 ANDA ANDA040521 Taro Pharmaceuticals U.S.A., Inc. PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 51672-4070_3afb12df-1994-4391-8e54-cdf41d3b6773 51672-4070 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20140501 ANDA ANDA076601 Taro Pharmaceuticals U.S.A., Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 51672-4074_49209aac-2b24-4c2b-b146-3f66b60a499e 51672-4074 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate Hydrocortisone Butyrate CREAM TOPICAL 20050804 ANDA ANDA076654 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-4075_48723753-8184-4cf9-b47b-f6bf8856636e 51672-4075 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin SOLUTION ORAL 20130703 ANDA ANDA076672 Taro Pharmaceuticals U.S.A., Inc. GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51672-4079_88a49efc-2967-4ee4-af03-a6dfbc031ecf 51672-4079 HUMAN PRESCRIPTION DRUG Desonide Desonide LOTION TOPICAL 20141031 ANDA ANDA202161 Taro Pharmaceuticals U.S.A., Inc. DESONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-4081_e6dac8ca-584d-4371-8a2e-fd903a0d5e64 51672-4081 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin phosphate SOLUTION TOPICAL 20040331 ANDA ANDA065184 Taro Pharmaceuticals U.S.A., Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 51672-4083_49209aac-2b24-4c2b-b146-3f66b60a499e 51672-4083 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate Hydrocortisone Butyrate OINTMENT TOPICAL 20041227 ANDA ANDA076842 Taro Pharmaceuticals U.S.A., Inc. HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-4085_7c68a555-1f43-4536-b395-4e3395f30c30 51672-4085 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET ORAL 20050218 ANDA ANDA076912 Taro Pharmaceuticals U.S.A., Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 51672-4086_7c68a555-1f43-4536-b395-4e3395f30c30 51672-4086 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET ORAL 20050218 ANDA ANDA076912 Taro Pharmaceuticals U.S.A., Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 51672-4087_7c68a555-1f43-4536-b395-4e3395f30c30 51672-4087 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET ORAL 20050218 ANDA ANDA076912 Taro Pharmaceuticals U.S.A., Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 51672-4091_c92f3dfd-c5d7-451c-8930-4684e6ee6153 51672-4091 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron hydrochloride SOLUTION ORAL 20071130 ANDA ANDA077009 Taro Pharmaceuticals U.S.A., Inc. ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 51672-4095_6359624d-5d38-47db-8ae5-214ff908179d 51672-4095 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate OINTMENT TOPICAL 20050614 ANDA ANDA077145 Taro Pharmaceuticals U.S.A., Inc. FLUTICASONE PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-4105_d4292ac7-519a-4a92-be8d-1d1bc4635522 51672-4105 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071115 ANDA ANDA077801 Taro Pharmaceuticals U.S.A., Inc. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51672-4106_d4292ac7-519a-4a92-be8d-1d1bc4635522 51672-4106 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071115 ANDA ANDA077801 Taro Pharmaceuticals U.S.A., Inc. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51672-4107_d4292ac7-519a-4a92-be8d-1d1bc4635522 51672-4107 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071115 ANDA ANDA077801 Taro Pharmaceuticals U.S.A., Inc. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51672-4108_02c93e5e-bc97-483b-9442-ea0446bb0be8 51672-4108 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20110328 ANDA ANDA077729 Taro Pharmaceuticals U.S.A., Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 51672-4109_02c93e5e-bc97-483b-9442-ea0446bb0be8 51672-4109 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20110328 ANDA ANDA077729 Taro Pharmaceuticals U.S.A., Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 51672-4110_02c93e5e-bc97-483b-9442-ea0446bb0be8 51672-4110 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20110328 ANDA ANDA077729 Taro Pharmaceuticals U.S.A., Inc. ONDANSETRON HYDROCHLORIDE 24 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 51672-4111_fef5f04c-7385-4c56-92bb-352a663a3400 51672-4111 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20060905 ANDA ANDA040684 Taro Pharmaceuticals U.S.A., Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 51672-4116_d5b90aeb-7cd5-48b8-97a5-8d6f3307e2a3 51672-4116 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole GEL TOPICAL 20060718 ANDA ANDA077819 Taro Pharmaceuticals U.S.A., Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 51672-4117_e9a9d100-81bf-4514-b8ad-170e9a12d342 51672-4117 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 19880229 ANDA ANDA062876 Taro Pharmaceuticals U.S.A., Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 51672-4118_838583b2-b014-48f0-9cf2-da8e57511678 51672-4118 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil CREAM TOPICAL 20100305 ANDA ANDA090368 Taro Pharmaceuticals U.S.A., Inc. FLUOROURACIL 50 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 51672-4123_54781e7a-02ee-426b-845f-d6d71d8bb6e0 51672-4123 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20090331 ANDA ANDA078115 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 51672-4124_54781e7a-02ee-426b-845f-d6d71d8bb6e0 51672-4124 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20090331 ANDA ANDA078115 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 51672-4125_54781e7a-02ee-426b-845f-d6d71d8bb6e0 51672-4125 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20090331 ANDA ANDA078115 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 400 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 51672-4130_7d095770-d871-4aea-a5bb-d6ca779f6382 51672-4130 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Taro Pharmaceuticals U.S.A., Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 51672-4131_7d095770-d871-4aea-a5bb-d6ca779f6382 51672-4131 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Taro Pharmaceuticals U.S.A., Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 51672-4132_7d095770-d871-4aea-a5bb-d6ca779f6382 51672-4132 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Taro Pharmaceuticals U.S.A., Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 51672-4133_7d095770-d871-4aea-a5bb-d6ca779f6382 51672-4133 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078525 Taro Pharmaceuticals U.S.A., Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 51672-4136_5ee175e2-14c7-4413-8fb3-170f082c017b 51672-4136 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090210 ANDA ANDA078774 Taro Pharmaceuticals U.S.A., Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51672-4137_5ee175e2-14c7-4413-8fb3-170f082c017b 51672-4137 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20100201 ANDA ANDA078960 Taro Pharmaceuticals U.S.A., Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51672-4138_792dd502-e445-4b74-b5f9-a946e4c3f57e 51672-4138 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET, FILM COATED ORAL 20100528 ANDA ANDA090817 Taro Pharmaceuticals U.S.A., Inc. GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 51672-4139_ee442bae-dda7-456f-8114-8d003513a625 51672-4139 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090204 ANDA ANDA079204 Taro Pharmaceuticals U.S.A., Inc. LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 51672-4140_ee442bae-dda7-456f-8114-8d003513a625 51672-4140 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090204 ANDA ANDA079204 Taro Pharmaceuticals U.S.A., Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 51672-4141_5ee175e2-14c7-4413-8fb3-170f082c017b 51672-4141 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20100201 ANDA ANDA078960 Taro Pharmaceuticals U.S.A., Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51672-4142_5ee175e2-14c7-4413-8fb3-170f082c017b 51672-4142 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20100201 ANDA ANDA078960 Taro Pharmaceuticals U.S.A., Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51672-4143_5ee175e2-14c7-4413-8fb3-170f082c017b 51672-4143 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20100201 ANDA ANDA078960 Taro Pharmaceuticals U.S.A., Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51672-4144_56dd77b4-82ca-4556-a3d6-fc0d1e88ca29 51672-4144 HUMAN PRESCRIPTION DRUG DARANIDE dichlorphenamide TABLET ORAL 20120316 NDA NDA011366 Taro Pharmaceuticals U.S.A., Inc. DICHLORPHENAMIDE 50 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 51672-4145_cd5069f0-4bdf-46cf-8278-cc821732f5c8 51672-4145 HUMAN PRESCRIPTION DRUG Imiquimod Imiquimod CREAM TOPICAL 20110415 ANDA ANDA200173 Taro Pharmaceuticals U.S.A., Inc. IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] N 20181231 51672-4146_f3b2034c-75bc-4777-aabb-ae158935d867 51672-4146 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin TABLET, CHEWABLE ORAL 20140417 ANDA ANDA200565 Taro Pharmaceuticals U.S.A., Inc PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 51672-4147_8ab0fb0e-0f17-41d5-8fc6-6fa87412b265 51672-4147 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20110523 ANDA ANDA200998 Taro Pharmaceuticals U.S.A., Inc. MEPROBAMATE 200 mg/1 CIV N 20181231 51672-4148_8ab0fb0e-0f17-41d5-8fc6-6fa87412b265 51672-4148 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20110523 ANDA ANDA200998 Taro Pharmaceuticals U.S.A., Inc. MEPROBAMATE 400 mg/1 CIV N 20181231 51672-4149_a14d0afb-9662-4eb8-bf0b-1ad220873f90 51672-4149 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20130621 ANDA ANDA201106 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 300 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 51672-4150_a14d0afb-9662-4eb8-bf0b-1ad220873f90 51672-4150 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20130621 ANDA ANDA201106 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 51672-4151_a14d0afb-9662-4eb8-bf0b-1ad220873f90 51672-4151 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20130621 ANDA ANDA201106 Taro Pharmaceuticals U.S.A., Inc. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 51672-4154_63587cb5-a2b7-4c1c-95cf-3333566fdee8 51672-4154 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene OINTMENT TOPICAL 20100324 ANDA ANDA090633 Taro Pharmaceuticals U.S.A., Inc. CALCIPOTRIENE .05 mg/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 51672-4155_9ad52567-50fc-4046-812b-7a3f01492444 51672-4155 HUMAN PRESCRIPTION DRUG Adapalene Adapalene GEL TOPICAL 19960531 NDA AUTHORIZED GENERIC NDA020380 Taro Pharmaceuticals U.S.A., Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 51672-4159_4e3d4c62-ca09-4a45-8fe8-0faccb492037 51672-4159 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine SOLUTION ORAL 20150701 ANDA ANDA202592 Taro Pharmaceuticals U.S.A., Inc. DESLORATADINE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 51672-4161_d4dcee43-4df3-4341-a5e2-4eb648074fd1 51672-4161 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine dihydrochloride SOLUTION ORAL 20130726 ANDA ANDA202673 Taro Pharmaceuticals U.S.A., inc. LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 51672-4164_c56c39ac-ce2b-4db2-b380-32f4d95b8a69 51672-4164 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL TOPICAL 20170314 ANDA ANDA204651 Taro Pharmaceuticals U.S.A., Inc. METRONIDAZOLE 10 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 51672-4165_e82a0372-5569-4d60-a328-7bcf97a92d5b 51672-4165 HUMAN PRESCRIPTION DRUG Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide SYRUP ORAL 20170227 ANDA ANDA205112 Taro Pharmaceuticals U.S.A., Inc. BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 2; 30; 10 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] N 20181231 51672-4172_ff558824-b008-4b94-8aa5-d7818bc27a4f 51672-4172 HUMAN PRESCRIPTION DRUG Felbamate Felbamate SUSPENSION ORAL 20170616 ANDA ANDA206314 Taro Pharmaceuticals U.S.A., Inc. FELBAMATE 600 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51672-4177_822bc66c-a00b-4e14-9ad9-0d2ab2fe9956 51672-4177 HUMAN PRESCRIPTION DRUG Keveyis Dichlorphenamide TABLET ORAL 20150807 NDA NDA011366 Taro Pharmaceuticals U.S.A., inc. DICHLORPHENAMIDE 50 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 51672-4185_a28f204b-407c-41af-90d5-b68a8048a915 51672-4185 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20170420 ANDA ANDA207093 Taro Pharmaceuticals U.S.A., inc. FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51672-4186_a28f204b-407c-41af-90d5-b68a8048a915 51672-4186 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20170420 ANDA ANDA207093 Taro Pharmaceuticals U.S.A., inc. FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51672-4188_987e98dd-68eb-4374-8169-9cae7b81a0a3 51672-4188 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate AEROSOL, FOAM TOPICAL 20170524 ANDA ANDA208204 Taro Pharmaceuticals U.S.A., Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-5202_a100b090-355e-4b0d-998b-1af7c7bdfe6f 51672-5202 HUMAN PRESCRIPTION DRUG Topicort Desoximetasone GEL TOPICAL 19980714 ANDA ANDA074904 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-5203_8c01b42a-db87-4e0e-a662-26ec24b9ba26 51672-5203 HUMAN PRESCRIPTION DRUG Topicort Desoximetasone OINTMENT TOPICAL 19921215 ANDA ANDA074286 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-5204_a100b090-355e-4b0d-998b-1af7c7bdfe6f 51672-5204 HUMAN PRESCRIPTION DRUG Topicort Desoximetasone CREAM TOPICAL 19901130 ANDA ANDA073193 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-5205_a100b090-355e-4b0d-998b-1af7c7bdfe6f 51672-5205 HUMAN PRESCRIPTION DRUG Topicort Desoximetasone CREAM TOPICAL 19901130 ANDA ANDA073210 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-5263_c5a8402b-932d-4e78-9257-2fbaba1e19d3 51672-5263 HUMAN PRESCRIPTION DRUG Topicort Desoximetasone OINTMENT TOPICAL 19850117 NDA NDA018594 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-5276_b25a87f3-4f04-4af3-8764-2cd11ef99913 51672-5276 HUMAN PRESCRIPTION DRUG OVIDE MALATHION LOTION TOPICAL 19820802 NDA NDA018613 TARO PHARMACEUTICALS USA, INC. MALATHION .005 g/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 51672-5277_a3510c3b-9538-4ce6-9736-95f9079c71c8 51672-5277 HUMAN PRESCRIPTION DRUG MALATHION MALATHION LOTION TOPICAL 20090802 NDA NDA018613 TARO PHARMACEUTICALS U.S.A., INC. MALATHION .005 g/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 51672-5278_73697e23-5b86-4c5a-8aaf-af73af066e76 51672-5278 HUMAN PRESCRIPTION DRUG Calcitrene Calcipotriene OINTMENT TOPICAL 20100324 ANDA ANDA090633 Taro Pharmaceuticals U.S.A., Inc. CALCIPOTRIENE .05 mg/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 51672-5281_7878f0be-3256-4e3d-8e15-dc7a7c98c592 51672-5281 HUMAN PRESCRIPTION DRUG Topicort Desoximetasone SPRAY TOPICAL 20130411 NDA NDA204141 Taro Pharmaceuticals U.S.A., Inc. DESOXIMETASONE 2.5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-5292_6387f11e-cb78-4118-974c-2580ebf149a3 51672-5292 HUMAN PRESCRIPTION DRUG psorcon Diflorasone Diacetate CREAM TOPICAL 20140801 ANDA ANDA075508 Taro Pharmaceuticals U.S.A., Inc. DIFLORASONE DIACETATE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-5293_56cd9886-2003-4e81-bef4-8b9c2d00c42b 51672-5293 HUMAN PRESCRIPTION DRUG Ovide Malathion LOTION TOPICAL 20140131 ANDA ANDA091559 Taro Pharmaceuticals U.S.A., Inc. MALATHION .0005 g/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 51672-5294_6023342b-5c41-4990-8403-d554a3323088 51672-5294 HUMAN PRESCRIPTION DRUG Malathion Malathion LOTION TOPICAL 20140131 ANDA ANDA091559 Taro Pharmaceuticals U.S.A., Inc. MALATHION .0005 g/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 51672-5295_f3698d33-814b-4ad1-8aa8-0728b8041dcc 51672-5295 HUMAN PRESCRIPTION DRUG metronidazole metronidazole GEL TOPICAL 20050630 NDA AUTHORIZED GENERIC NDA021789 Taro Pharmaceuticals U.S.A., Inc. METRONIDAZOLE 10 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 51672-5296_2df5aa5d-cfb3-4df1-9a17-83e49236da33 51672-5296 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20150601 ANDA ANDA040428 Taro Pharmaceuticals U.S.A., Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51672-5297_2df5aa5d-cfb3-4df1-9a17-83e49236da33 51672-5297 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20150601 ANDA ANDA040428 Taro Pharmaceuticals U.S.A., Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 51672-5298_e8f8ad91-84e0-4050-9856-136b38341951 51672-5298 HUMAN PRESCRIPTION DRUG Flurandrenolide Flurandrenolide LOTION TOPICAL 20160425 NDA NDA013790 Taro Pharmaceuticals U.S.A., Inc. FLURANDRENOLIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-5301_35858be1-8e9a-453e-97c5-b03b80f22015 51672-5301 HUMAN PRESCRIPTION DRUG Flurandrenolide Flurandrenolide CREAM TOPICAL 20160425 NDA NDA012806 Taro Pharmaceuticals U.S.A., Inc. FLURANDRENOLIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51672-5302_36a1a80c-d31c-40db-af63-0db573c94406 51672-5302 HUMAN PRESCRIPTION DRUG Ciclopirox ciclopirox SOLUTION TOPICAL 20160404 ANDA ANDA078233 Taro Pharmaceuticals U.S.A., Inc. CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 51672-5305_4894092b-93c2-423b-b755-7403d56720e5 51672-5305 HUMAN PRESCRIPTION DRUG PLIAGLIS lidocaine and tetracaine CREAM TOPICAL 20170503 NDA NDA021717 Taro Pharmaceuticals U.S.A., Inc. LIDOCAINE; TETRACAINE 70; 70 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 51673-001_93eef5c7-3b70-4633-b4ed-c5ba1aafe228 51673-001 HUMAN OTC DRUG ZANG QI CAMPHOR (NATURAL) PLASTER TRANSDERMAL 20100604 OTC MONOGRAPH NOT FINAL part348 QINGHAI ZANGYUANTANG BIO-TECH CO LTD CAMPHOR (NATURAL) 3.1 g/1 E 20171231 51674-0117_7190b816-cd3f-4bcc-9349-0d35ade7fcbd 51674-0117 HUMAN PRESCRIPTION DRUG CORTANE-B HYDROCORTISONE, PRAMOXINE HCL, CHLOROXYLENOL LOTION TOPICAL 20170320 UNAPPROVED DRUG OTHER BLANSETT PHARMACAL CO HYDROCORTISONE; PRAMOXINE HYDROCHLORIDE; CHLOROXYLENOL 10; 10; 1 mg/mL; mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 51674-0130_85f9ed27-9fce-4cd5-9cb2-7dc9d6c06cb1 51674-0130 HUMAN PRESCRIPTION DRUG RELEGARD GLACIAL ACETIC ACID, OXYQUINOLINE GEL TOPICAL 20170320 UNAPPROVED DRUG OTHER BLANSETT PHARMACAL CO ACETIC ACID; OXYQUINOLINE .9; .025 mg/mL; mg/mL N 20191231 51681-0001_3957b480-1b0b-47de-8ee4-2822d1478cb6 51681-0001 HUMAN OTC DRUG WHITE FLOWER ANALGESIC BALM CAMPHOR, MENTHOL, AND METHYL SALICYLATE OIL TRANSDERMAL 20100614 OTC MONOGRAPH NOT FINAL part348 JELMA PHILIPPINES INC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 6; 14.6; 40 g/100mL; g/100mL; g/100mL N 20181231 51681-0011_dea788c1-49a7-4f2a-8e70-792372de679d 51681-0011 HUMAN OTC DRUG WHITE FLOWER ANALGESIC BALM FLORAL SCENTED CAMPHOR, MENTHOL AND METHYL SALICYLATE OIL TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part348 JELMA PHILIPPINES INC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 5.4; 13; 35.8 g/100mL; g/100mL; g/100mL N 20181231 51681-0041_ac4655a0-6c2f-4cbd-ad49-9c57c85e7798 51681-0041 HUMAN OTC DRUG WHITE FLOWER STRAIN RELIEF CAMPHOR, MENTHOL AND METHYL SALICYLATE OIL TOPICAL 20120220 OTC MONOGRAPH NOT FINAL part348 JELMA PHILIPPINES INC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 15; 50 g/100mL; g/100mL; g/100mL N 20181231 51683-000_61e395ab-e2ba-1908-e053-2a91aa0a3f19 51683-000 HUMAN OTC DRUG SOTHYS PARIS Sunscreen Face and Body Broad Spectrum SPF 30 UVA/UVB AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20140209 OTC MONOGRAPH NOT FINAL part352 Sothys Paris AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 51683-002_34dd6e9e-9dad-49bf-e054-00144ff8d46c 51683-002 HUMAN OTC DRUG Sunscreen Face and Body Broad Spectrum SPF 30 OCTOCRYLENE, OCTINOXATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20160608 OTC MONOGRAPH NOT FINAL part352 Sothys Paris OCTOCRYLENE; OCTINOXATE; OXYBENZONE; AVOBENZONE 100; 75; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 51688-5473_9e69db8b-c8f3-447b-b3fb-632f4d685919 51688-5473 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL 19840103 OTC MONOGRAPH NOT FINAL part333A Smiths Medical ASD, INC POVIDONE-IODINE 9.8 g/100g N 20181231 51693-001_2331f0d5-5876-48a6-b2ff-2c836464777e 51693-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS Ridgeview Home Medical Equipment OXYGEN 99 L/100L E 20171231 51702-114_178df289-8507-479d-9354-6cb3e8f47f61 51702-114 HUMAN OTC DRUG Sun Defeated Sunscreen Avobenzone, Octocrylene, Oxybenzone, Octisalate LOTION TOPICAL 20120312 OTC MONOGRAPH FINAL part352 Mission AVOBENZONE; OCTOCRYLENE; OXYBENZONE; OCTISALATE 2.79; 6.51; 3.74; 7.44 g/93g; g/93g; g/93g; g/93g E 20171231 51706-111_bf81f0a8-7645-4682-9957-2f05c5a2de31 51706-111 HUMAN OTC DRUG Bodycology Cherry Blossom Triclosan GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International TRICLOSAN .3 mL/100mL E 20171231 51706-112_99e4408e-8ce2-4281-af5a-339628a33b35 51706-112 HUMAN OTC DRUG Bodycology Coconut Lime Triclosan CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International TRICLOSAN .3 mL/100mL E 20171231 51706-113_9bb371f4-f52a-4483-a20a-f64993c887d6 51706-113 HUMAN OTC DRUG Bodycology Brown Sugar Vanilla Triclosan GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International TRICLOSAN .3 mL/100mL E 20171231 51706-114_a19ec217-eaa7-4af8-8fba-b494d3219631 51706-114 HUMAN OTC DRUG Bodycology Cucumber Melon Triclosan GEL TOPICAL 20100616 OTC MONOGRAPH NOT FINAL part333 Landy International TRICLOSAN .3 mL/100mL E 20171231 51706-115_2a321d39-b474-42e0-90bf-d74d547808de 51706-115 HUMAN OTC DRUG Bodycology White Gardenia Triclosan GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International TRICLOSAN .3 mL/100mL E 20171231 51706-201_50a66a9f-2070-4b0f-a76e-115b64beef87 51706-201 HUMAN OTC DRUG Bodycology Cherry Blossom Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100625 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 65 mL/100mL E 20171231 51706-202_024d5dcf-ac54-4317-bd9d-759d69634ac5 51706-202 HUMAN OTC DRUG Bodycology Brown Sugar Vanilla Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100625 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 65 mL/100mL E 20171231 51706-203_ecc1529e-af2c-4d0e-aa72-71f49871932e 51706-203 HUMAN OTC DRUG Bodycology Cucumber Melon Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100708 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 65 mL/100mL E 20171231 51706-204_ca326053-21ac-4ccc-b753-86d0df355d97 51706-204 HUMAN OTC DRUG Bodycology Sweet Petals Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100625 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 65 mL/100mL E 20171231 51706-205_e9dfdede-10b3-4a31-99ae-edf9fc6dbd43 51706-205 HUMAN OTC DRUG Bodycology Sweet Petals Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100708 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 65 mL/100mL E 20171231 51706-301_a49075de-c21d-4650-b638-5c4b1e4128af 51706-301 HUMAN OTC DRUG Bodycology Moisturizing Hand Sanitizer Brown Sugar Vanilla Alcohol CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL E 20171231 51706-302_be355741-e4dd-4155-aab2-712a827a67be 51706-302 HUMAN OTC DRUG Bodycology Moisturizing Hand Sanitizer Cherry Blossom Alcohol CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL E 20171231 51706-303_605b3afa-c2b9-4acf-95e3-d51b9eb4f881 51706-303 HUMAN OTC DRUG Bodycology Moisturizing Hand Sanitizer Cucumber Melon Alcohol GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL E 20171231 51706-304_8dcab923-01a5-4976-bbf2-a5c8ce226925 51706-304 HUMAN OTC DRUG Bodycology Moisturizing Hand Sanitizer Midnight Garden Alcohol GEL TOPICAL 20100630 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL E 20171231 51706-305_f477a18a-38aa-43db-8f68-87f194bc0197 51706-305 HUMAN OTC DRUG Bodycology Moisturizing Hand Sanitizer Sweet Petals Alcohol GEL TOPICAL 20100630 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL E 20171231 51706-306_31421adc-3ff9-416f-a021-feb887e0f861 51706-306 HUMAN OTC DRUG Bodycology Moisturizing Hand Sanitzer White Gardenia Alcohol CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL E 20171231 51706-400_96121232-d21c-48e3-828e-1e23a96589d1 51706-400 HUMAN OTC DRUG Bodycology Hand Sanitizer Gift Set Ethyl Alcohol GEL TOPICAL 20100813 OTC MONOGRAPH NOT FINAL part333 Landy International ALCOHOL 70 mL/100mL E 20171231 51706-500_811e59bd-c138-4c5e-ac46-038eec5c51bc 51706-500 HUMAN OTC DRUG HAND SANITIZER ALCOHOL GEL TOPICAL 20120614 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL E 20171231 51706-501_2115792b-d753-40ca-a074-dc810ff024cb 51706-501 HUMAN OTC DRUG Hand Sanitizer Pink Strawberry Lollipop Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL E 20171231 51706-502_2d357b05-7d8b-49cb-944d-d5dc8c97a35c 51706-502 HUMAN OTC DRUG Hand Sanitizer Winter Jelly Bean Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL E 20171231 51706-503_1338852a-4594-4d4b-b2f7-5ec66bd18641 51706-503 HUMAN OTC DRUG Hand Sanitizer Passionfruit Pomegranate Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL E 20171231 51706-504_02b9d687-f30d-4828-8ed5-320e68b72dde 51706-504 HUMAN OTC DRUG Hand Sanitizer Orange Tangerine Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL E 20171231 51706-505_8069383e-249b-4b4e-b8ea-5c27a995b11a 51706-505 HUMAN OTC DRUG Hand Sanitizer Sweet Sugar Cookie Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL E 20171231 51706-506_c04a2408-4cb6-41c6-9d02-70b890e2f279 51706-506 HUMAN OTC DRUG Hand Sanitizer Passionfruit Pomegranate Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL E 20171231 51706-507_d94dc316-669e-4d73-99e7-fb45d6d1b82d 51706-507 HUMAN OTC DRUG Hand Sanitizer Spicy Peppermint Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL E 20171231 51706-508_0e1a0fb6-f1d2-4e1e-8556-5a4d83c35687 51706-508 HUMAN OTC DRUG Hand Sanitizer Sugared Berry Alcohol LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL E 20171231 51706-509_55f1ecc6-097b-495b-9daa-67d71a650598 51706-509 HUMAN OTC DRUG Hand Sanitizer Cranberry Tart Alcohol LIQUID TOPICAL 20140418 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL E 20171231 51706-510_2c43ad0a-0284-4721-8ec8-b92a0eaed81e 51706-510 HUMAN OTC DRUG Hand Sanitizer Sugar Coated Plum Alcohol LIQUID TOPICAL 20140418 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 62 mL/100mL E 20171231 51706-511_6bf364d3-9495-46d7-bf23-660324909026 51706-511 HUMAN OTC DRUG Ritz Spritz Mulled Cranberry Alcohol GEL TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 63 1/100g E 20171231 51706-512_2af19afe-6fdc-4cc0-a012-7346dee90fe1 51706-512 HUMAN OTC DRUG Glitter Ritz Iced Berry Alcohol GEL TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 63 1/100g E 20171231 51706-513_97fd5a2d-b5b0-44ad-b9db-16f7a46f6a9a 51706-513 HUMAN OTC DRUG Glitter Ritz Golden Vanilla Embers Alcohol GEL TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 63 1/100g E 20171231 51706-600_ccce671f-381f-41cb-b534-a5ad6916967d 51706-600 HUMAN OTC DRUG HAND SANITIZER ALCOHOL GEL TOPICAL 20150417 OTC MONOGRAPH NOT FINAL part333E Landy International ALCOHOL 65 mL/100mL E 20171231 51706-602_603644df-3225-7995-e053-2a91aa0af441 51706-602 HUMAN OTC DRUG Moonglade Hand Sanitizer Alcohol GEL TOPICAL 20171213 OTC MONOGRAPH NOT FINAL part333A Landy International ALCOHOL 60 g/100g N 20181231 51706-603_604755c5-f2ef-3bbf-e053-2a91aa0a43cb 51706-603 HUMAN OTC DRUG Energy Infusion Hand Sanitizer Alcohol GEL TOPICAL 20171214 OTC MONOGRAPH NOT FINAL part333A Landy International ALCOHOL 60 g/100g N 20181231 51715-001_f1fe3676-395d-43e8-b4c1-5441c70424d9 51715-001 HUMAN OTC DRUG Lidocoll Lidocaine HCL SPRAY TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part348 Innocoll Pharmaceuticals LIDOCAINE HYDROCHLORIDE 4.6 g/115g E 20171231 51718-2111_e70b65c3-ebc2-43fd-afdb-21e0763deccb 51718-2111 HUMAN OTC DRUG Instant Hand Sanitizer Citrus Scent alcohol GEL TOPICAL 20100826 OTC MONOGRAPH NOT FINAL part333E Telestar Consulting ALCOHOL .665 g/mL N 20181231 51718-3111_728681d6-f63b-4c1c-8522-ad2c50badb01 51718-3111 HUMAN OTC DRUG Antiseptic alcohol LIQUID TOPICAL 20120320 OTC MONOGRAPH NOT FINAL part333E Telestar Consulting ALCOHOL 665 mL/L N 20181231 51718-3112_6d593eaf-6202-4e0e-b838-d76c85bd0d8f 51718-3112 HUMAN OTC DRUG Antiseptic alcohol LIQUID TOPICAL 20150319 OTC MONOGRAPH NOT FINAL part333E Telestar ALCOHOL 665 mL/L N 20181231 51720-421_817bad9e-3bc0-44bd-b626-e1c6def461fb 51720-421 HUMAN OTC DRUG Berberis Antiseptic Berberis Aquifolium, Calendula Officinalis, Hydrastis Canadensis, Acid Boric, Zinc Oxide, Borax, Calcium Sulphate, Antimonium Crudum CREAM TOPICAL 20090815 UNAPPROVED HOMEOPATHIC Curative Power Lab PVT LTD MAHONIA AQUIFOLIUM ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; GOLDENSEAL; BORIC ACID; ZINC OXIDE; SODIUM BORATE; CALCIUM SULFATE; ANTIMONY TRISULFIDE 2; 2; 2; 1; 1; 1; 1; 1 [hp_X]/21g; [hp_X]/21g; [hp_X]/21g; [hp_X]/21g; [hp_X]/21g; [hp_X]/21g; [hp_X]/21g; [hp_X]/21g E 20171231 51720-653_8dd9c95b-fd76-4c58-bfa0-c2125dd52270 51720-653 HUMAN OTC DRUG Tyn Mans Natrum Salicylicum, Kalium Iodatum, Caffeine, Natrum Citricum, Cimicifuga TINCTURE ORAL 20090815 UNAPPROVED HOMEOPATHIC Curative Power Lab PVT LTD SODIUM SALICYLATE; POTASSIUM IODIDE; CAFFEINE; SODIUM CITRATE; BLACK COHOSH 1; 1; 1; 1; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 51720-734_ca288dcb-03be-4c63-83e1-bb271b6333ca 51720-734 HUMAN OTC DRUG MittiHeal Natural Wound Care Calendula Officinalis, Arnica Montana POWDER TOPICAL 20090815 UNAPPROVED HOMEOPATHIC Curative Power Lab PVT LTD CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA 6; 6 [hp_X]/10g; [hp_X]/10g E 20171231 51727-0631_92c06df6-f2e8-458a-b19f-5dd28daa52e4 51727-0631 HUMAN OTC DRUG Urban Defense Octocrylene and Octinoxate EMULSION TOPICAL 20120716 OTC MONOGRAPH FINAL part352 Urban Decay Cosmetics, LLC OCTOCRYLENE; OCTINOXATE 4; 3.75 mL/50mL; mL/50mL E 20171231 51727-0632_92c06df6-f2e8-458a-b19f-5dd28daa52e4 51727-0632 HUMAN OTC DRUG Urban Defense Octocrylene and Octinoxate EMULSION TOPICAL 20120716 OTC MONOGRAPH FINAL part352 Urban Decay Cosmetics, LLC OCTOCRYLENE; OCTINOXATE 4; 3.75 mL/50mL; mL/50mL E 20171231 51727-0633_92c06df6-f2e8-458a-b19f-5dd28daa52e4 51727-0633 HUMAN OTC DRUG Urban Defense Octocrylene and Octinoxate EMULSION TOPICAL 20120716 OTC MONOGRAPH FINAL part352 Urban Decay Cosmetics, LLC OCTOCRYLENE; OCTINOXATE 4; 3.75 mL/50mL; mL/50mL E 20171231 51727-0634_92c06df6-f2e8-458a-b19f-5dd28daa52e4 51727-0634 HUMAN OTC DRUG Urban Defense Octocrylene and Octinoxate EMULSION TOPICAL 20120716 OTC MONOGRAPH FINAL part352 Urban Decay Cosmetics, LLC OCTOCRYLENE; OCTINOXATE 4; 3.75 mL/50mL; mL/50mL E 20171231 51730-0001_e1e2da7c-2d2c-4a57-bc07-e5e5830b6b9d 51730-0001 HUMAN OTC DRUG Lymph Rx Ceanothus Americanus, Euphrasia Officinalis, Geranium Robertianum, Juglans Regia, Myosotis Arvensis, Sarsaparilla LIQUID ORAL 20130313 UNAPPROVED HOMEOPATHIC Health and Harmony Products CEANOTHUS AMERICANUS LEAF; EUPHRASIA STRICTA; GERANIUM ROBERTIANUM; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; MYOSOTIS ARVENSIS; SMILAX REGELII ROOT; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; ALTHAEA OFFICINALIS ROOT; PEUMUS BOLDUS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; THUJA OCCIDENTALIS LEAF; FUMARIA OFFICINALIS FLOWERING TOP; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; POTASSIUM IODIDE; ECHINACEA ANGUSTIFOLIA; NASTURTIUM OFFICINALE; VISCUM ALBUM FRUITING TOP; PHYTOLACCA AMERICANA ROOT; CAPSICUM; VERONICA OFFICINALIS FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; SODIUM SULFATE; BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFIDE; FERROUS IODIDE; MERCURIC CYANIDE; ARANEUS DIADEMATUS; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 3; 3; 3; 3; 4; 4; 4; 4; 8; 8; 8; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 51730-0002_f3f396f1-1b13-491d-adb6-642430730142 51730-0002 HUMAN OTC DRUG Lymph Care Ceanothus Americanus, Euphrasia Officinalis, Geranium Robertianum, Juglans Regia, Myosotis Arvensis, Sarsaparilla, Scrophularia Nodosa LIQUID ORAL 20130814 UNAPPROVED HOMEOPATHIC Health and Harmony Products CEANOTHUS AMERICANUS LEAF; EUPHRASIA STRICTA; GERANIUM ROBERTIANUM; JUGLANS REGIA LEAF; JUGLANS REGIA FRUIT RIND, IMMATURE; MYOSOTIS ARVENSIS; SARSAPARILLA; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; ALTHAEA OFFICINALIS ROOT; PEUMUS BOLDUS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; THUJA OCCIDENTALIS LEAF; FUMARIA OFFICINALIS FLOWERING TOP; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; POTASSIUM IODIDE; ECHINACEA, UNSPECIFIED; NASTURTIUM OFFICINALE; VISCUM ALBUM FRUITING TOP; PHYTOLACCA AMERICANA ROOT; CAPSICUM; VERONICA OFFICINALIS FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; SODIUM SULFATE; BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFIDE; FERROUS IODIDE; MERCURIC CYANIDE; ARANEUS DIADEMATUS; BOS TAURUS PARATHYROID GLAND; BOS TAURUS THYMUS; SUS SCROFA THYROID 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 3; 3; 3; 3; 4; 4; 4; 4; 8; 8; 8; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 51754-0203_e3b10021-3d3a-43de-bacb-899e65a505d2 51754-0203 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride INJECTION INTRAVENOUS 20160422 NDA NDA018925 EXELA PHARMA SCIENCES, LLC VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51754-0204_f1a97533-a1b0-4b0e-b4c2-76d5bee9b4e2 51754-0204 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride INJECTION INTRAVENOUS 20170201 NDA NDA018925 EXELA PHARMA SCIENCES, LLC VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51754-0500_f423a220-e7bf-4d24-bc52-bafc1864265b 51754-0500 HUMAN PRESCRIPTION DRUG caffeine citrate caffeine citrate INJECTION INTRAVENOUS 20060921 ANDA ANDA077233 Exela Pharma Sciences, LLC CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 51754-0501_ebf3db86-5da4-2353-9713-7e1ea0b59066 51754-0501 HUMAN PRESCRIPTION DRUG caffeine citrate CAFFEINE CITRATE SOLUTION ORAL 20060921 ANDA ANDA077304 Exela Pharma Sciences, LLC CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 51754-0502_c2213ac1-1975-4496-ad72-481eecbd3759 51754-0502 HUMAN PRESCRIPTION DRUG caffeine citrate CAFFEINE CITRATE INJECTION INTRAVENOUS 20060921 ANDA ANDA077233 Exela Pharma Sciences, LLC CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 51754-0503_e04788c0-e660-43eb-9dec-607de5cec11a 51754-0503 HUMAN PRESCRIPTION DRUG caffeine citrate CAFFEINE CITRATE SOLUTION ORAL 20060921 ANDA ANDA077304 Exela Pharma Sciences, LLC CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 51754-1006_f3af61e2-b11a-40f6-8d11-4b7db0094aa5 51754-1006 HUMAN PRESCRIPTION DRUG NIPRIDE RTU Sodium Nitroprusside INJECTION, SOLUTION INTRAVENOUS 20170320 NDA NDA209387 EXELA PHARMA SCIENCES, LLC SODIUM NITROPRUSSIDE .5 mg/mL Vasodilation [PE],Vasodilator [EPC] N 20181231 51754-2001_c71cf751-42a9-4fb0-a43d-edfb68ad9c85 51754-2001 HUMAN PRESCRIPTION DRUG Potassium Acetate POTASSIUM ACETATE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160107 ANDA ANDA206203 Exela Pharma Sciences, LLC. POTASSIUM ACETATE 3.93 g/20mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 51754-2500_238a983f-81bb-4033-b6ca-5fee7d6d291c 51754-2500 HUMAN PRESCRIPTION DRUG GANCICLOVIR GANCICLOVIR INJECTION, SOLUTION INTRAVENOUS 20170228 NDA NDA209347 EXELA PHARMA SCIENCES, LLC GANCICLOVIR 2 mg/mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 51758-003_c4aa9587-bddb-4243-b765-c4d17966e6d4 51758-003 HUMAN PRESCRIPTION DRUG Nitrogen c70f6047-a0cb-4f70-aa3a-78acd681efc3 Nitrogen LIQUID RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS Gases Plus Norco, LLC NITROGEN 999 L/1000L E 20171231 51758-004_745fc2f4-c030-453d-bec0-dbff153a80cb 51758-004 HUMAN PRESCRIPTION DRUG Oxygen 4c21e554-d402-480d-896d-8185c05c7863 Oxygen LIQUID RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS Gases Plus Norco, LLC OXYGEN 999 L/1000L E 20171231 51760-001_b95ab4fc-2de4-498d-801e-3b5029e455bc 51760-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20050819 ANDA ANDA203946 Essential Isotopes LLC FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 51760-002_5f498ddd-b133-437f-94c1-1b574f022645 51760-002 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20110101 ANDA ANDA204541 Essential Isotopes LLC SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 51760-003_b05bc1c2-48c5-4ba2-9be6-1aa373d68555 51760-003 HUMAN PRESCRIPTION DRUG Ammonia N 13 NH3N13 INJECTION INTRAVENOUS 20130219 ANDA ANDA205687 Essential Isotopes AMMONIA N-13 260 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 51769-002_f417a71f-7351-40f1-ac5a-05536bb745ba 51769-002 HUMAN OTC DRUG TING Athetes foot Undecylenic acid, Triclosan CREAM CUTANEOUS 20130109 OTC MONOGRAPH FINAL part333C ALL NATURAL DYNAMICS UNDECYLENIC ACID; TRICLOSAN 3.78; .1 g/100g; g/100g E 20171231 51769-003_050c22b8-dc2f-414c-a4ad-13468bd28728 51769-003 HUMAN OTC DRUG TING Cream Undecylenic acid, Triclosan CREAM CUTANEOUS 20130315 OTC MONOGRAPH FINAL part333C ALL NATURAL DYNAMICS UNDECYLENIC ACID; TRICLOSAN 3.78; .1 g/100g; g/100g E 20171231 51769-105_ed663d70-2279-4e16-98fe-152c6da4e253 51769-105 HUMAN OTC DRUG OBAO Soft Freshness ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130902 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g E 20171231 51769-107_c94e1ee6-fe8a-415f-b13f-b4fe91258e54 51769-107 HUMAN OTC DRUG Obao Bamboo Breeze Aluminum Chlorohydrate STICK TOPICAL 20130301 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g E 20171231 51769-123_48767cdd-c72a-45a0-a69e-c89a3a1c3213 51769-123 HUMAN OTC DRUG Obao Floral Freshness ALUMINUM CHLOROHYDRATE STICK TOPICAL 20130312 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g E 20171231 51769-124_f4b42768-3a6d-464a-92b5-94d7a57a2e06 51769-124 HUMAN OTC DRUG antiperspirant deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g E 20171231 51769-125_eda0e98f-2879-4334-8c9b-fb338e4a4fdb 51769-125 HUMAN OTC DRUG Obao Cool Metal Aluminum Chlorohydrate STICK TOPICAL 20130301 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g E 20171231 51769-127_572e8cfb-376f-4588-afbf-0a3cbcc694a5 51769-127 HUMAN OTC DRUG Obao Active ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20100331 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g E 20171231 51769-133_6c83ea07-49b7-4448-ba47-bc80062868f6 51769-133 HUMAN OTC DRUG Head and Shoulders menthol fresh Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130124 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNAMICS PYRITHIONE ZINC .01 g/mL E 20171231 51769-134_8a5d9da2-91e2-4b94-8bfa-384ef298217e 51769-134 HUMAN OTC DRUG Head and Shoulders menthol fresh Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130124 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNAMICS PYRITHIONE ZINC .01 g/mL E 20171231 51769-139_bee61e39-5dbe-4dc0-b6bd-d753fe128346 51769-139 HUMAN OTC DRUG Head and Shoulders renewing clean Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130129 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNAMICS PYRITHIONE ZINC .01 g/mL E 20171231 51769-140_e99160c9-87f4-4ca9-9765-0cef60308776 51769-140 HUMAN OTC DRUG Head and Shoulders hair loss prevention Pyrithione Zinc SHAMPOO TOPICAL 20130201 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNAMICS PYRITHIONE ZINC .01 g/mL E 20171231 51769-141_f58016ec-c5ab-4943-bd2b-e85b04fac313 51769-141 HUMAN OTC DRUG Head and Shoulders breakage prevention Pyrithione Zinc SHAMPOO TOPICAL 20130201 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNAMICS PYRITHIONE ZINC .01 g/mL E 20171231 51769-411_8b520486-b7e9-4074-b666-5e5614068bf8 51769-411 HUMAN OTC DRUG Obao Sensitive Passion Aluminum Chlorohydrate STICK TOPICAL 20130301 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g E 20171231 51769-412_e341a078-48af-41ea-9997-869f72bdaebb 51769-412 HUMAN OTC DRUG Obao Sensitive Passion Aluminum Chlorohydrate STICK TOPICAL 20130301 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g E 20171231 51769-555_4b816b38-e0dc-4ef5-ae2d-837ab9173a8e 51769-555 HUMAN OTC DRUG MUM CHAMOMILE Aluminum Chlorohydrate STICK TOPICAL 20130301 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g E 20171231 51769-614_a01e67cc-29df-415d-b742-a6ca74b63604 51769-614 HUMAN OTC DRUG Clarant B3 Avobenzone Octinoxate CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 ALL NATURAL DYNAMICS AVOBENZONE; OCTINOXATE 2800; 7100 mg/100g; mg/100g E 20171231 51769-615_22a06b2d-dda0-49ed-b729-b22715f8ff17 51769-615 HUMAN OTC DRUG PONDS clarant b3 Anti-Dark Moisturizing Cream CREAM TOPICAL 20120629 OTC MONOGRAPH FINAL part352 ALL NATURAL DYNAMICS AVOBENZONE 3 g/100g E 20171231 51769-666_4311bbeb-fece-4b8e-80a9-292e0a91befc 51769-666 HUMAN OTC DRUG Lady Speed Stick Aluminum Chlorohydrate STICK TOPICAL 20130301 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g E 20171231 51769-888_ffb56df0-1f94-4f1f-8703-ffd2cc905587 51769-888 HUMAN OTC DRUG Obao Men Audaz Aluminum Chlorohydrate LIQUID TOPICAL 20130823 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 15 g/100g E 20171231 51769-890_0e7fbffb-5081-4335-8d84-e3c9b03f1742 51769-890 HUMAN OTC DRUG PONDS VAO-B3 AVOBENZONE CREAM TOPICAL 20130902 OTC MONOGRAPH FINAL part352 ALL NATURAL DYNAMICS AVOBENZONE 3 g/100g E 20171231 51769-901_9f63604f-8dae-449c-87eb-a2ba10617f14 51769-901 HUMAN OTC DRUG Head and Shoulders smooth and silky Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20130124 OTC MONOGRAPH FINAL part358H ALL NATURAL DYNAMICS PYRITHIONE ZINC .01 g/mL E 20171231 51769-980_61d9c594-134a-4112-a985-09d075498cf0 51769-980 HUMAN OTC DRUG STEFANO Fire ALUMINUM CHLOROHYDRATE STICK TOPICAL 20120517 OTC MONOGRAPH FINAL part350 ALL NATURAL DYNAMICS ALUMINUM CHLOROHYDRATE 25 g/100mL E 20171231 51770-001_15f4b372-3274-4abb-9a22-89e441d6409f 51770-001 HUMAN OTC DRUG Truth Revealed super creme SPF 15 Ole Henriksen Octinoxate, Avobenzone, Oxybenzone, Octocrylene CREAM TOPICAL 20100815 OTC MONOGRAPH FINAL part352 Ole Henriksen OCTINOXATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE 7.5; 2; 2; 1.9 g/100g; g/100g; g/100g; g/100g N 20181231 51770-110_4c548ab4-9bee-4e93-8af2-9b35bab3ec87 51770-110 HUMAN OTC DRUG perfect truth cc eye broad spectrum SPF 15 OleHenriksen Avobenzone, Homosalate, Octocrylene CREAM TOPICAL 20130327 OTC MONOGRAPH NOT FINAL part352 Ole Henriksen AVOBENZONE; HOMOSALATE; OCTOCRYLENE 2; 5; 1.86 g/100mL; g/100mL; g/100mL E 20171231 51770-111_2b099a6e-ac88-4b0a-ae7a-c89cb5cca368 51770-111 HUMAN OTC DRUG Perfect Truth cc Broad Spectrum SPF 30 Ole Henriksen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20130327 OTC MONOGRAPH NOT FINAL part352 Ole Henriksen AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 5; 7.5; 5; 1.86 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 51770-112_19871cae-b72b-49a9-a6bd-f4ad74a5b762 51770-112 HUMAN OTC DRUG perfect truth cc broad spectrum SPF 30 sunscreen Ole Henriksen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Ole Henriksen AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 5; 7.5; 5; 1.86 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 51770-154_ec107a68-23c3-4d5d-b348-5d7218f16340 51770-154 HUMAN OTC DRUG Total Truth Eye Creme SPF 15 Ole Henriksen AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20110314 OTC MONOGRAPH NOT FINAL part352 Ole Henriksen of Denmark AVOBENZONE; OCTINOXATE; OCTISALATE 2; 4; 4 g/100g; g/100g; g/100g N 20181231 51770-222_7fde4113-6e12-4ff8-80ce-a4adee12188c 51770-222 HUMAN OTC DRUG Protect The Truth SPF 50 Ole Henriksen AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE,OXYBENZONE LOTION TOPICAL 20110315 OTC MONOGRAPH NOT FINAL part352 Ole Henriksen of Denmark AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.7; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 51772-311_ec21fe5a-b1f8-405e-9d75-6c01a24c9e51 51772-311 HUMAN PRESCRIPTION DRUG LAZANDA Fentanyl Citrate SPRAY NASAL 20111017 NDA NDA022569 Archimedes Pharma US Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 51772-314_ec21fe5a-b1f8-405e-9d75-6c01a24c9e51 51772-314 HUMAN PRESCRIPTION DRUG LAZANDA Fentanyl Citrate SPRAY NASAL 20111017 NDA NDA022569 Archimedes Pharma US Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 51785-455_5d8de303-6509-e64c-e053-2a91aa0a499b 51785-455 HUMAN OTC DRUG Herbalife SKIN 7 Day Results Kit Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone KIT 20140701 OTC MONOGRAPH FINAL part352 Herbalife International of America Inc. N 20181231 51785-809_3e88a845-afec-6ec5-e054-00144ff8d46c 51785-809 HUMAN OTC DRUG Skin Clearify Spot Treatment Salicylic Acid LIQUID TOPICAL 20161001 OTC MONOGRAPH FINAL part333D Herbalife International of America Inc. SALICYLIC ACID 1.5 mg/100mL N 20181231 51785-812_3e88eeb7-b95e-73a5-e054-00144ff8d46c 51785-812 HUMAN OTC DRUG Skin Clearify Moisturizer Salicylic Acid LIQUID TOPICAL 20161001 OTC MONOGRAPH FINAL part333D Herbalife International of America Inc. SALICYLIC ACID 2 g/100mL N 20181231 51785-816_3e88a845-b02f-6ec5-e054-00144ff8d46c 51785-816 HUMAN OTC DRUG Skin Clearify Mask Salicylic Acid LIQUID TOPICAL 20161001 OTC MONOGRAPH FINAL part333D Herbalife International of America Inc. SALICYLIC ACID .6 g/100mL N 20181231 51785-819_3e88cb4b-f95e-72c7-e054-00144ff8d46c 51785-819 HUMAN OTC DRUG Skin Clearify Cleanser Salicylic Acid LIQUID TOPICAL 20161001 OTC MONOGRAPH FINAL part333D Herbalife International of America Inc. SALICYLIC ACID .6 g/100mL N 20181231 51785-899_5e23ee24-e4b7-d18f-e053-2a91aa0ad3ee 51785-899 HUMAN OTC DRUG Herbalife Skin Protective Moisturizer SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part352 Herbalife International of America Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .9711; 1.56; 1.515; .8505; 1.8 g/30mL; g/30mL; g/30mL; g/30mL; g/30mL N 20181231 51785-921_5d69a177-5f92-6854-e053-2a91aa0ac363 51785-921 HUMAN OTC DRUG Herbal Aloe Face and Body SPF 30 Avobenzone. Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20140825 OTC MONOGRAPH FINAL part352 Herbalife International of America Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.8844; 6.24; 6.06; 3.4; 7.2 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 51790-100_16d9a260-2d36-46fc-b5d5-a0e66d2c6a04 51790-100 HUMAN OTC DRUG Breathable Concealer Light Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171207 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 86; 64 mg/mL; mg/mL N 20181231 51790-101_16d9a260-2d36-46fc-b5d5-a0e66d2c6a04 51790-101 HUMAN OTC DRUG Breathable Concealer Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171207 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 86; 64 mg/mL; mg/mL N 20181231 51790-102_16d9a260-2d36-46fc-b5d5-a0e66d2c6a04 51790-102 HUMAN OTC DRUG Breathable Concealer Tan Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171207 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 86; 64 mg/mL; mg/mL N 20181231 51790-300_a01be934-667a-430c-a471-796c9064aaf4 51790-300 HUMAN OTC DRUG Breathable Tint 1 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 86; 64 mg/mL; mg/mL N 20191231 51790-301_a01be934-667a-430c-a471-796c9064aaf4 51790-301 HUMAN OTC DRUG Breathable Tint 2 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 86; 64 mg/mL; mg/mL N 20191231 51790-302_a01be934-667a-430c-a471-796c9064aaf4 51790-302 HUMAN OTC DRUG Breathable Tint 3 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 86; 64 mg/mL; mg/mL N 20191231 51790-303_a01be934-667a-430c-a471-796c9064aaf4 51790-303 HUMAN OTC DRUG Breathable Tint 4 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 86; 64 mg/mL; mg/mL N 20191231 51790-400_c289d903-04fe-4055-a9ef-45835981e031 51790-400 HUMAN OTC DRUG Lycogel Breathable Balm OCTINOXATE,OXYBENZONE,OCTISALATE and AVOBENZONE CREAM TOPICAL 20171207 OTC MONOGRAPH FINAL part352 Quura Medical B.V OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 75; 60; 50; 20; 15 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 51790-500_4f4cfe53-2a78-4f7a-8677-86509bff5de5 51790-500 HUMAN OTC DRUG Breathable Camouflage Light IVORY Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 82; 65 mg/mL; mg/mL N 20181231 51790-501_4f4cfe53-2a78-4f7a-8677-86509bff5de5 51790-501 HUMAN OTC DRUG Breathable Camouflage Light CREME Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171207 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 82; 65 mg/mL; mg/mL N 20181231 51790-502_4f4cfe53-2a78-4f7a-8677-86509bff5de5 51790-502 HUMAN OTC DRUG Breathable Camouflage Light BEIGE Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 82; 65 mg/mL; mg/mL N 20181231 51790-503_4f4cfe53-2a78-4f7a-8677-86509bff5de5 51790-503 HUMAN OTC DRUG Breathable Camouflage Light HONEY Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 82; 65 mg/mL; mg/mL N 20181231 51790-504_4f4cfe53-2a78-4f7a-8677-86509bff5de5 51790-504 HUMAN OTC DRUG Breathable Camouflage Light CARAMEL Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 82; 65 mg/mL; mg/mL N 20181231 51790-505_4f4cfe53-2a78-4f7a-8677-86509bff5de5 51790-505 HUMAN OTC DRUG Breathable Camouflage Light TAUPE Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171207 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 82; 65 mg/mL; mg/mL N 20181231 51790-506_4f4cfe53-2a78-4f7a-8677-86509bff5de5 51790-506 HUMAN OTC DRUG Breathable Camouflage Light ALMOND Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 82; 65 mg/mL; mg/mL N 20181231 51790-507_4f4cfe53-2a78-4f7a-8677-86509bff5de5 51790-507 HUMAN OTC DRUG Breathable Camouflage Light COCOA Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 82; 65 mg/mL; mg/mL N 20181231 51790-508_4f4cfe53-2a78-4f7a-8677-86509bff5de5 51790-508 HUMAN OTC DRUG Breathable Camouflage Light PEARL Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171207 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 82; 65 mg/mL; mg/mL N 20181231 51790-509_4f4cfe53-2a78-4f7a-8677-86509bff5de5 51790-509 HUMAN OTC DRUG Breathable CamouflageLight SAND Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 82; 65 mg/mL; mg/mL N 20181231 51790-510_4f4cfe53-2a78-4f7a-8677-86509bff5de5 51790-510 HUMAN OTC DRUG Breathable Camouflage Light AMBER Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 82; 65 mg/mL; mg/mL N 20181231 51790-511_4f4cfe53-2a78-4f7a-8677-86509bff5de5 51790-511 HUMAN OTC DRUG Breathable Camouflage Light Tawny Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20171223 OTC MONOGRAPH FINAL part352 Quura Medical B.V ZINC OXIDE; TITANIUM DIOXIDE 82; 65 mg/mL; mg/mL N 20181231 51791-001_9e77defa-9329-4187-bd32-84b7ed8ec0d6 51791-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS Eastern Welding Supply, Inc OXYGEN 99 L/100L E 20171231 51801-001_63ede6be-645a-4386-a575-47a4d5469a54 51801-001 HUMAN PRESCRIPTION DRUG Effer-K Orange POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 977.5 mg/1 N 20181231 51801-003_4fa258b9-db62-43ff-a941-7f5632b17ffe 51801-003 HUMAN PRESCRIPTION DRUG GloStrips Fluorescein Sodium STRIP OPHTHALMIC 20130730 UNAPPROVED DRUG OTHER Nomax Inc. FLUORESCEIN SODIUM .6 mg/1 Diagnostic Dye [EPC],Dyes [MoA] N 20181231 51801-004_f3985299-bba9-495a-ba21-87c59bf1db66 51801-004 HUMAN PRESCRIPTION DRUG GloStrips Rose Bengal Sodium STRIP OPHTHALMIC 20130820 UNAPPROVED DRUG OTHER Nomax Inc. ROSE BENGAL SODIUM 1.3 mg/1 N 20181231 51801-005_63ede6be-645a-4386-a575-47a4d5469a54 51801-005 HUMAN PRESCRIPTION DRUG Effer-K Lemon Citrus POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 977.5 mg/1 N 20181231 51801-006_63ede6be-645a-4386-a575-47a4d5469a54 51801-006 HUMAN PRESCRIPTION DRUG Effer-K Cherry Berry POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 977.5 mg/1 N 20181231 51801-007_63ede6be-645a-4386-a575-47a4d5469a54 51801-007 HUMAN PRESCRIPTION DRUG Effer-K Unflavored POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 977.5 mg/1 N 20181231 51801-008_08dd04c1-ca76-4b5d-ae29-1479238743b2 51801-008 HUMAN PRESCRIPTION DRUG Dry Eye Test Fluorescein Sodium STRIP OPHTHALMIC 20131205 UNAPPROVED DRUG OTHER Nomax Inc. FLUORESCEIN SODIUM .12 mg/1 Diagnostic Dye [EPC],Dyes [MoA] N 20181231 51801-009_3ed3e55d-c387-4bdc-b406-aa413a73d73a 51801-009 HUMAN PRESCRIPTION DRUG GloStrips Fluorescein Sodium STRIP OPHTHALMIC 20130730 UNAPPROVED DRUG OTHER Nomax Inc. FLUORESCEIN SODIUM 1 mg/1 Diagnostic Dye [EPC],Dyes [MoA] N 20181231 51801-011_5fe7d30f-2394-4fcc-b41d-198812ef4e6b 51801-011 HUMAN PRESCRIPTION DRUG Effer-K 20 mEq Unflavored POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 782 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 51801-012_5fe7d30f-2394-4fcc-b41d-198812ef4e6b 51801-012 HUMAN PRESCRIPTION DRUG Effer-K 20 mEq Orange Cream POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 782 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 51801-013_5fe7d30f-2394-4fcc-b41d-198812ef4e6b 51801-013 HUMAN PRESCRIPTION DRUG Effer-K 10 mEq Unflavored POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 391 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 51801-014_5fe7d30f-2394-4fcc-b41d-198812ef4e6b 51801-014 HUMAN PRESCRIPTION DRUG Effer-K 10 mEq Cherry Vanilla POTASSIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130130 UNAPPROVED DRUG OTHER Nomax Inc. POTASSIUM BICARBONATE 391 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 51803-001_5653c364-92a5-23e3-e054-00144ff88e88 51803-001 HUMAN OTC DRUG IOSAT Potassium Iodide TABLET ORAL 19821014 NDA NDA018664 Anbex Inc. POTASSIUM IODIDE 130 mg/1 N 20181231 51803-002_5653aec0-e29a-264e-e054-00144ff88e88 51803-002 HUMAN OTC DRUG IOSAT Potassium Iodide TABLET ORAL 20130501 NDA NDA018664 Anbex Inc. POTASSIUM IODIDE 65 mg/1 N 20181231 51808-101_40ecc37d-84df-4f1c-ab4b-30d0c06718a2 51808-101 HUMAN PRESCRIPTION DRUG Sodium Chromate 51 Sodium Chromate 51 SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation CHROMIUM CR-51 1 mCi/5mL E 20171231 51808-102_130c71b9-1a33-45b2-ab19-e38b6ee0ee68 51808-102 HUMAN PRESCRIPTION DRUG I 123 Mini I 123 Mini CAPSULE ORAL 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation IODIDE ION I-123 10 mCi/1 Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 51808-103_ea9f7125-98b5-49c3-85b8-763915156ff0 51808-103 HUMAN PRESCRIPTION DRUG i 123 MIBG meta iodobenzylguanidine i 123 MIBG INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation IOBENGUANE SULFATE I-123 25 mCi/1 E 20171231 51808-119_5811e231-e65f-4771-9875-7d8f6197473f 51808-119 HUMAN PRESCRIPTION DRUG I 131 Mini I 131 Mini CAPSULE ORAL 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation SODIUM IODIDE I-131 500 mCi/1 E 20171231 51808-125_0e714ae6-396c-4488-868e-bfe5fd446f3f 51808-125 HUMAN PRESCRIPTION DRUG In-111 DTPA In-111 DTPA SOLUTION INTRATHECAL 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation INDIUM IN-111 PENTETATE DISODIUM 3.75 mCi/1.5mL Lead Chelating Activity [MoA],Lead Chelator [EPC] E 20171231 51808-126_b16e5845-c429-4530-969b-a7cbabe43116 51808-126 HUMAN PRESCRIPTION DRUG Indium 111 Oxyquinolone Indium 111 Oxyquinolone SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation INDIUM IN-111 OXYQUINOLINE 2 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 51808-127_5ed86373-1e27-42fc-a3b3-b198944f0dff 51808-127 HUMAN PRESCRIPTION DRUG P32 Sodium Phosphate P32 Sodium Phosphate INJECTION, SUSPENSION INTERSTITIAL; INTRA-ARTICULAR; INTRAPERITONEAL; INTRAPLEURAL 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation PHOSPHORUS P-32 5 mCi/mL E 20171231 51808-128_c099d1ae-d9f6-4176-b55c-233ce52b2976 51808-128 HUMAN PRESCRIPTION DRUG P32 Sodium Phosphate P32 Sodium Phosphate SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation PHOSPHORUS P-32 10 mCi/4mL E 20171231 51808-201_651af678-d1d2-4e8e-8fe0-ae6c0ba11a16 51808-201 HUMAN PRESCRIPTION DRUG ACD Solution Modified ACD Solution Modified SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation ANHYDROUS CITRIC ACID 8 mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 51808-203_8f9023fb-e982-440a-a9ee-374c4bf3153b 51808-203 HUMAN PRESCRIPTION DRUG SIncalide Sincalide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation SINCALIDE 3 ug/1 Cholecystokinin [Chemical/Ingredient],Cholecystokinin Analog [EPC] E 20171231 51808-204_71f96ee3-a363-4345-9ab6-5270ae323fab 51808-204 HUMAN PRESCRIPTION DRUG Dipyridamole Dipridamole SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation DIPYRIDAMOLE 5 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 51808-206_25e39c45-5f86-400f-beab-63f773e54734 51808-206 HUMAN PRESCRIPTION DRUG Isosulfan Blue Isosulfan Blue SOLUTION SUBCUTANEOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation ISOSULFAN BLUE 10 mg/mL E 20171231 51808-207_9292f201-2136-4da5-9d6f-0d7daca2de1e 51808-207 HUMAN PRESCRIPTION DRUG Pentagastrin Pentagastrin SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation PENTAGASTRIN 250 ug/1.6mL E 20171231 51808-208_118e6927-25b5-4bcc-8716-fcb5dbdc487b 51808-208 HUMAN PRESCRIPTION DRUG Sestamibi Sestamibi INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1.5 mg/1 E 20171231 51808-209_ad867c7e-d1fa-4587-9c3e-26a40fcf0ccc 51808-209 HUMAN PRESCRIPTION DRUG Thyrotropin Releasing Hormone TRH Thyrotropin Releasing Hormone SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation PROTIRELIN 500 ug/mL E 20171231 51808-210_29c1fd45-7d77-4882-9e73-8a66742be742 51808-210 HUMAN PRESCRIPTION DRUG Dextran 75 Dextran 75 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120701 UNAPPROVED DRUG OTHER AnazaoHealth Corporation DEXTRAN 75 10 mg/1 Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA] E 20171231 51808-211_ec657ecb-6327-464c-8aab-6d61a0546b83 51808-211 HUMAN PRESCRIPTION DRUG Dimercaptosuccinic Acid DMSA Dimercaptosuccinic Acid INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120701 UNAPPROVED DRUG OTHER AnazaoHealth Corporation 2,3-DIMERCAPTOSUCCINIC ACID 1.1 mg/1 E 20171231 51808-213_fb2f24ff-01b1-4afe-9a24-dfa98fa1f047 51808-213 HUMAN PRESCRIPTION DRUG Glucoheptonate Glucoheptonate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation CALCIUM GLUCEPTATE 50 mg/1 E 20171231 51808-214_dd2d8053-37a4-465d-9086-2bd084c4898c 51808-214 HUMAN PRESCRIPTION DRUG Exametazime HMPAO Exametazime INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120701 UNAPPROVED DRUG OTHER AnazaoHealth Corporation EXAMETAZIME 1 mg/1 E 20171231 51808-216_4d7406b4-8bcd-40f0-a31f-975f5b811da7 51808-216 HUMAN PRESCRIPTION DRUG Mebrofenin Mebrofenin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120619 UNAPPROVED DRUG OTHER AnazaoHealth Corporation MEBROFENIN 10 mg/1 E 20171231 51808-217_b780bd14-67f7-4dd6-8d36-f53a6d38152c 51808-217 HUMAN PRESCRIPTION DRUG Bicisate Bicisate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation BICISATE 1.35 mg/1 E 20171231 51808-218_e247d821-b132-4a87-a71a-8bc13c71fcfc 51808-218 HUMAN PRESCRIPTION DRUG Pyrophosphate Pyrophosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation SODIUM PYROPHOSPHATE 27.6 mg/1 E 20171231 51808-220_7c1f657a-07f0-4f9f-9552-1688174e2130 51808-220 HUMAN PRESCRIPTION DRUG Sulfur Colloid Sulfur Colloid INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120701 UNAPPROVED DRUG OTHER AnazaoHealth Corporation GELATIN 4.5 mg/1 E 20171231 51808-223_0edc9a01-f669-4e7c-af14-cee9bfb3daa3 51808-223 HUMAN PRESCRIPTION DRUG Tetrofosmin Tetrofosmin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation TETROFOSMIN .35 mg/1 E 20171231 51808-223_89513168-46fb-471f-9566-e2240cedfa84 51808-223 HUMAN PRESCRIPTION DRUG Tetrofosmin Tetrofosmin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120523 UNAPPROVED DRUG OTHER AnazaoHealth Corporation TETROFOSMIN .35 mg/1 E 20171231 51811-065_3a1c7b69-5635-4bf7-a6c7-32ebfb061507 51811-065 HUMAN OTC DRUG Hydrating Instant Hand Sanitizer Alcohol GEL TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part333E HANOVER PEN CORP dba HPC Global ALCOHOL 10.35 mL/14.78mL E 20171231 51811-066_661845fe-fe56-4fd3-9bae-5283e25c7274 51811-066 HUMAN OTC DRUG Antibacterial Protective Hand Chlorhexidine Gluconate LOTION TOPICAL 20130201 UNAPPROVED DRUG OTHER Hanover Pen Corp dba HPC Global CHLORHEXIDINE GLUCONATE .07075 g/14.15g E 20171231 51811-352_826396f4-8e7d-4ddc-bc2b-48603219d349 51811-352 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol SPRAY TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 5.58 mL/9mL N 20181231 51811-352_f7f154f9-107c-4078-9daa-38117165b413 51811-352 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol SPRAY TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 5.58 mL/9mL N 20181231 51811-353_8b4ad367-b6fb-45fa-8b6f-d80a9dcba35b 51811-353 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol SPRAY TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 2.79 mL/4.5mL N 20181231 51811-353_92e04d25-9124-4be0-8ebf-cffd62c1ff34 51811-353 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol SPRAY TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 2.79 mL/4.5mL N 20181231 51811-362_d7657ce7-76d6-430b-ae15-dd0f7b6c5d2d 51811-362 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol GEL TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 19.66 mL/29.57mL E 20171231 51811-362_e8b2eb0f-020e-4e4e-bca9-4d78dd0d52cb 51811-362 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol GEL TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 19.66 mL/29.57mL E 20171231 51811-363_34e29508-e76f-43ea-9885-427e579fcd0b 51811-363 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol GEL TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 39.33 mL/59.14mL E 20171231 51811-363_6b691ec6-f50e-4622-813f-3c55222f67a4 51811-363 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol GEL TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 39.33 mL/59.14mL E 20171231 51811-368_80a05c50-5626-4ab5-af43-c3f667b7e046 51811-368 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol GEL TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 19.66 mL/29.57mL E 20171231 51811-368_8d0100e9-ae0d-4961-8a64-9c77844b286b 51811-368 HUMAN OTC DRUG Antimicrobial Hand Sanitizer Alcohol GEL TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL 19.66 mL/29.57mL E 20171231 51811-374_88e2dfa9-05e6-4130-84b2-2c5784105199 51811-374 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL N 20181231 51811-374_d133f9ab-cb6d-4d54-9912-8ec1fbf2becc 51811-374 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL N 20181231 51811-375_6a816ac1-9280-4d8f-a9d0-868c5e5a283f 51811-375 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL N 20181231 51811-375_86d17974-2f96-43b3-893b-7e922f825bea 51811-375 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL N 20181231 51811-376_3c61da8b-2dc6-43eb-97b3-96983d1458bc 51811-376 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL N 20181231 51811-376_5cd2190d-dccf-4c5d-9a91-5b221e9a6724 51811-376 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL N 20181231 51811-377_8821ed7c-0e44-46d6-8c78-da40471eb4dc 51811-377 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL N 20181231 51811-377_b1608634-6985-4b7e-9636-68357b78d78a 51811-377 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333E Hanover Pen Corp dba HPC Global ALCOHOL .665 g/mL N 20181231 51811-658_db32639b-8fd0-4078-b3c6-ae9485f7f5f6 51811-658 HUMAN OTC DRUG Antibacterial Protective Hand Chlorhexidine Gluconate LOTION TOPICAL 20130201 UNAPPROVED DRUG OTHER Hanover Pen Corp dba HPC Global CHLORHEXIDINE GLUCONATE .0045 g/.9g E 20171231 51811-659_e62b853f-85bf-4983-af77-6825dd5e5438 51811-659 HUMAN OTC DRUG Hydrating Instant Hand Sanitizer Alcohol GEL TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part333E HANOVER PEN CORP dba HPC Global ALCOHOL .6329 mL/.9242mL E 20171231 51812-0001_19a8c1aa-0a21-4945-afde-f5c00b31c677 51812-0001 HUMAN OTC DRUG Rejuvenation HGH Fucus Vesiculosus, Cyanocobalamin, Glandula Suprarenalis Suis, Hepar Suis, Thyroidinum, Pancreatinum LIQUID ORAL 20130220 UNAPPROVED HOMEOPATHIC Degen Health Products FUCUS VESICULOSUS; CYANOCOBALAMIN; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA THYROID; PANCRELIPASE; SUS SCROFA HYPOTHALAMUS; SOMATROPIN; SUS SCROFA PITUITARY GLAND 2; 6; 6; 6; 8; 12; 18; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 51815-208_e25e264d-dd26-4fb4-8e4c-ecef82db92d1 51815-208 HUMAN OTC DRUG Right Guard Sport Active Aluminum Zirconium Trichlorohydrex GLY STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part350 VVF Illinois Services LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 7.14 g/51g E 20171231 51815-209_3242fa6d-53bb-4c28-b939-e87d35e766d9 51815-209 HUMAN OTC DRUG Right Guard Sport Fresh Aluminum Zirconium Octachlorhydrex GLY GEL TOPICAL 20140320 OTC MONOGRAPH FINAL part350 VVF Illinois Services ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 13.94 1/85g N 20181231 51815-213_ac43282a-0b2c-47cc-9905-cda4c10345e1 51815-213 HUMAN OTC DRUG Right Guard Xtreme Clear Clean Aluminum Zirconium Tetrachlorohydrex STICK TOPICAL 20130101 OTC MONOGRAPH FINAL part350 VVF Illinois Services LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g N 20181231 51815-214_410ce7e4-47dc-432c-9dab-ab898f20e7f6 51815-214 HUMAN OTC DRUG Right Guard Total Defense 5 Arctic Refresh Aluminum Zirconium Octachlorhydrex GLY GEL TOPICAL 20140101 OTC MONOGRAPH FINAL part350 VVF Illinois Services LLC ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 18.5 g/113g N 20181231 51815-215_652dfa90-dbbd-4f88-a398-268911d6e024 51815-215 HUMAN OTC DRUG Right Guard Xtreme Clear Fresh Aluminum Zirconium Tetrachlorohydrex STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 VVF Illinois Services LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g N 20181231 51815-216_ddb3d3a5-d298-40da-8b35-edcd9d529efe 51815-216 HUMAN OTC DRUG Right Guard Clinical Clear Clean Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 VVF Illinois Services ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 48 g/48g N 20181231 51815-217_2df64b8e-0eb3-44a3-a6b5-a0b6ba83dcfe 51815-217 HUMAN OTC DRUG Soft and Dri Dri Gel Soft Scent Aluminum Zirconium Octochlorohydrex STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part350 VVF Illinois Services ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 85 g/85g E 20171231 51815-218_e9cbe397-f95e-4ea8-b5e0-e7d0746a8a6c 51815-218 HUMAN OTC DRUG Dry Idea Advanced Dry Fresh Aluminum Zirconium Octachlorohydrex GLY STICK TOPICAL 20140317 OTC MONOGRAPH FINAL part350 VVF Illinois Services LLC ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 13.94 g/85g N 20181231 51815-223_3f95245d-c839-4bf4-b540-c631aaa44b74 51815-223 HUMAN OTC DRUG Dry Idea Clinical Clear Clean Aluminum Zirconium Tetrachlorohydrex GLY 20.0% STICK TOPICAL 20140402 OTC MONOGRAPH FINAL part350 VVF Illinois Services ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 9.6 g/48g N 20181231 51815-224_61b50bc0-be16-45ac-be65-4faba15483da 51815-224 HUMAN OTC DRUG Dry Idea Clean Aluminum Zirconium Tetrachlorohydrex GLY 19.0% STICK TOPICAL 20140204 OTC MONOGRAPH FINAL part350 VVF Illinois Services ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g N 20181231 51815-225_8f4ce4e3-a987-4a51-b5bd-e3bece84d12c 51815-225 HUMAN OTC DRUG Right Guard Sport Triathlon Aluminum Zirconium Octachlorhydrex GLY STICK TOPICAL 20140320 OTC MONOGRAPH FINAL part350 VVF Illinois Services ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 7.14 g/51g N 20181231 51815-300_596f3643-c3d6-4af6-aec7-9cfd100f813c 51815-300 HUMAN OTC DRUG Dial antibacterial Triclocarban SOAP TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part333E VVF Illinois Services LLC TRICLOCARBAN .339 g/113g N 20181231 51815-301_f28bbeeb-7ebe-4c82-961f-e91f1d6b7a27 51815-301 HUMAN OTC DRUG Dial White Triclocarban SOAP TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part333E VVF Illinois Services LLC TRICLOCARBAN 113 g/113g N 20181231 51815-302_ff539acc-6c86-4693-b3f3-4b70cde7404a 51815-302 HUMAN OTC DRUG Dial Aloe Aloe Triclocarban SOAP TOPICAL 20140527 OTC MONOGRAPH NOT FINAL part333E VVF Illinois Services LLC TRICLOCARBAN 1.017 g/339g N 20181231 51815-303_299aadee-e95d-4d3a-9e49-904f16e18fd2 51815-303 HUMAN OTC DRUG Dial Odor Armor Odor Armor Triclocarban SOAP TOPICAL 20140527 OTC MONOGRAPH NOT FINAL part333E VVF Illinois Services LLC TRICLOCARBAN 1.017 g/339g N 20181231 51815-307_dab74e14-b673-46b3-a492-2a858096dc2c 51815-307 HUMAN OTC DRUG Dial Acne Acne Triclocarban SOAP TOPICAL 20140527 OTC MONOGRAPH FINAL part333D VVF Illinois Services LLC SALICYLIC ACID 4.8 g/240g N 20181231 51817-170_ac9b6796-6673-4d8a-a743-66f5b868bea5 51817-170 HUMAN PRESCRIPTION DRUG Busulfan busulfan INJECTION INTRAVENOUS 20170519 ANDA ANDA207050 Pharmascience Inc. BUSULFAN 6 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 51822-021_62fb4c14-cf22-5250-e053-2991aa0af59d 51822-021 HUMAN OTC DRUG Petrocort Antipruritic Lip 21 HYDROCORTISONE LIPSTICK TOPICAL 20171226 OTC MONOGRAPH NOT FINAL part348 Clinical Formula LLC HYDROCORTISONE .005 g/g N 20191231 51823-3574_db176641-37de-4f06-aab3-69e84a6b1a0b 51823-3574 HUMAN OTC DRUG JiDeSheng Clotrimazole GEL TOPICAL 20101023 OTC MONOGRAPH FINAL part333C UPC Medical Supplies, Inc. CLOTRIMAZOLE 1 g/100g E 20171231 51824-001_1b6a1ccb-72a6-4179-92c2-035841f2bee8 51824-001 HUMAN OTC DRUG CAREALL Tolnaftate Tolnaftate CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part333C New World Imports, Inc TOLNAFTATE 10 mg/g N 20181231 51824-002_b0e5d089-00b6-4b50-925b-174b50003ad6 51824-002 HUMAN OTC DRUG CAREALL Hydrocortisone Maximum Strength Hydrocortisone Acetate CREAM TOPICAL 20100830 20191231 OTC MONOGRAPH NOT FINAL part348 New World Imports, Inc HYDROCORTISONE ACETATE 10 mg/g N 20181231 51824-003_42daa6e9-ca32-4d98-b8d3-92c068b8dabd 51824-003 HUMAN OTC DRUG CAREALL Bacitracin Bacitracin Zinc CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part333B New World Imports, Inc BACITRACIN ZINC 500 [USP'U]/g N 20181231 51824-004_b1d6122a-6ad3-4f5e-901a-642ef2ec088e 51824-004 HUMAN OTC DRUG NWI LUBRICATING DEXTRAN 70 AND HYDROXYPROPYL METHYLCELLULOSE SOLUTION OPHTHALMIC 20110110 OTC MONOGRAPH FINAL part349 NEW WORLD IMPORTS, INC. DEXTRAN 70; HYPROMELLOSE 2910 (15000 MPA.S) .001; .003 mL/mL; mL/mL N 20181231 51824-006_3f34250f-885e-435d-9b77-1bea2f5119f0 51824-006 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate OINTMENT TOPICAL 20120601 20200101 OTC MONOGRAPH FINAL part333B New World Imports, Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 51824-007_f131a552-b13e-4a93-943c-73b2c896d64c 51824-007 HUMAN OTC DRUG CAREALL Muscle Rub Ultra Strength Menthol, Methyl Salicylate CREAM TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part348 New World Imports, Inc MENTHOL; METHYL SALICYLATE 100; 150 mg/g; mg/g N 20181231 51824-008_1f5d4bdc-2751-477e-9253-705a12b362f7 51824-008 HUMAN OTC DRUG CAREALL Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20120601 20200101 OTC MONOGRAPH NOT FINAL part348 New World Imports Inc ZINC OXIDE .2 g/g N 20181231 51824-009_42326d65-28f4-4445-9071-e557f5a4935e 51824-009 HUMAN OTC DRUG CAREALL Vitamin A and D Lanolin and Petrolatum OINTMENT TOPICAL 20120601 20200101 OTC MONOGRAPH FINAL part347 New World Imports, Inc LANOLIN; PETROLATUM .01; .97 g/g; g/g N 20181231 51824-010_8f19d15a-1c8e-4128-9c31-39f816e6ae4b 51824-010 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100910 20200801 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN 325 mg/1 N 20181231 51824-011_defab917-b8bd-46cf-bc38-450dc31f5b0d 51824-011 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20100914 20200801 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN 500 mg/1 N 20181231 51824-012_c8ef867b-4f84-4f37-8b77-6df5dc506de1 51824-012 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET, COATED ORAL 20100914 20190801 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN 500 mg/1 N 20181231 51824-014_8d5745a0-6df2-499d-987b-71a48a7bf419 51824-014 HUMAN OTC DRUG CAREALL Musle and Joint Menthol GEL TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part348 New World Imports, Inc MENTHOL 25 mg/g N 20181231 51824-018_7ed49f9c-3902-4dac-9220-01cd9851bd31 51824-018 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20120605 20200801 OTC MONOGRAPH NOT FINAL part343 New World Imports IBUPROFEN 200 mg/1 N 20181231 51824-019_77fbd487-68f2-46db-b81a-6d6a0f97006f 51824-019 HUMAN OTC DRUG Fresh Scent Petroleum PETROLATUM JELLY TOPICAL 20120605 20180601 OTC MONOGRAPH FINAL part347 New World Imports, Inc PETROLATUM 1 g/g N 20181231 51824-020_1ff86591-e544-4bb0-9cbe-9d23969d4de7 51824-020 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol GEL TOPICAL 20120612 OTC MONOGRAPH NOT FINAL part333A New World Imports, Inc. ALCOHOL .7 mL/mL N 20181231 51824-021_4c4c97bb-c8f8-4632-9b2f-c74b792ca078 51824-021 HUMAN OTC DRUG Freshscent Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20120614 OTC MONOGRAPH FINAL part350 New World Imports, Inc. ALUMINUM CHLOROHYDRATE 10 mg/100mL N 20181231 51824-022_90e1b9b3-9a26-4683-a8eb-ed59d509413e 51824-022 HUMAN OTC DRUG Freshscent Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20120614 OTC MONOGRAPH FINAL part350 New World Imports, Inc. ALUMINUM CHLOROHYDRATE 10 mg/100mL N 20181231 51824-023_8afe73ac-ead3-4555-81c1-5fdb0c8d1faf 51824-023 HUMAN OTC DRUG Freshscent Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SPRAY TOPICAL 20120614 OTC MONOGRAPH FINAL part350 New World Imports, Inc. ALUMINUM CHLOROHYDRATE 13 mg/100mL N 20181231 51824-024_eead4861-79be-4573-af82-07bf8a60b130 51824-024 HUMAN OTC DRUG Roll On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20120622 OTC MONOGRAPH FINAL part350 New World Imports ALUMINUM CHLOROHYDRATE 14 mg/100mL N 20181231 51824-026_f28f60c7-8c10-465b-ad0a-4eba3f14666b 51824-026 HUMAN OTC DRUG Senna-S Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20121201 20200801 OTC MONOGRAPH NOT FINAL part334 New World Imports, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 51824-029_ce89055c-2ed0-4756-9074-eb5a1ffac990 51824-029 HUMAN OTC DRUG Freshmint Premium Anticavity Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130101 OTC MONOGRAPH FINAL part355 New World Imports, Inc SODIUM FLUORIDE 2.43 mg/g N 20181231 51824-030_2f8cad86-63f0-4545-a72b-4caff900a8f7 51824-030 HUMAN OTC DRUG CAREALL Naproxen Naproxen Sodium CAPSULE ORAL 20130501 ANDA ANDA090545 New World Imports, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 51824-031_812c8b51-10a7-48b3-a618-b307affc052b 51824-031 HUMAN OTC DRUG Freshscent Anti-Bacterial Triclosan SOAP TOPICAL 20130401 20190601 OTC MONOGRAPH NOT FINAL part333E New World Imports TRICLOSAN .003 g/g N 20181231 51824-032_ce05652f-eba2-452b-9de7-f522dd899977 51824-032 HUMAN OTC DRUG CAREALL Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20130404 OTC MONOGRAPH NOT FINAL part348 New World Imports Inc ZINC OXIDE .2 g/g N 20181231 51824-033_1f9da21c-2c6e-42fa-956e-677b2fd73d1b 51824-033 HUMAN OTC DRUG CAREALL Vitamin A and D Lanolin and Petrolatum OINTMENT TOPICAL 20120501 OTC MONOGRAPH FINAL part347 New World Imports, Inc LANOLIN; PETROLATUM .01; .97 g/g; g/g N 20181231 51824-034_8c921d83-c3a2-42e3-9cea-7143b45dd423 51824-034 HUMAN OTC DRUG Freshmint Premium Anticavity Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130404 OTC MONOGRAPH FINAL part355 New World Imports, Inc SODIUM FLUORIDE 2.43 mg/g N 20181231 51824-038_1e426289-a4a0-485d-9862-81d502501970 51824-038 HUMAN OTC DRUG CAREALL Artifical Tears Glycerin, Hypromellose, Polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20140101 OTC MONOGRAPH FINAL part349 New World Imports, Inc GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL N 20181231 51824-039_591c5967-1d8c-45ce-a46e-f33e6a286936 51824-039 HUMAN OTC DRUG CAREALL Eyedrops Original Tetrahydrozoline HCI SOLUTION/ DROPS OPHTHALMIC 20140601 OTC MONOGRAPH FINAL part349 New World Imports, Inc TETRAHYDROZOLINE HYDROCHLORIDE .05 mg/mL N 20181231 51824-040_b5b59951-49af-4eb6-852d-ecdae6894672 51824-040 HUMAN OTC DRUG CAREALL Lubricating Eye Drops Dextran, Hydroxypropyl Methylcellulose SOLUTION/ DROPS OPHTHALMIC 20140601 OTC MONOGRAPH FINAL part349 New World Imports, Inc DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S) .1; .3 mg/mL; mg/mL N 20181231 51824-041_eee5edec-6901-44d8-9794-6ca81f9d5753 51824-041 HUMAN OTC DRUG CAREALL Petroleum PETROLATUM JELLY TOPICAL 20140601 OTC MONOGRAPH FINAL part347 New World Imports, Inc PETROLATUM 1 g/g N 20191231 51824-043_2502e47f-5893-4e5a-88b6-097cbb1a16f1 51824-043 HUMAN OTC DRUG Freshscent Antibacterial Deodorant Triclocarban SOAP TOPICAL 20140513 20190401 OTC MONOGRAPH NOT FINAL part333E New World Imports, Inc TRICLOCARBAN 6 mg/g N 20181231 51824-044_21c58a20-20f2-49a4-bb5d-e197491e6e44 51824-044 HUMAN OTC DRUG Freshscent Sport Antibacterial Triclocarban SOAP TOPICAL 20140701 20190601 OTC MONOGRAPH NOT FINAL part333E New World Imports, Inc TRICLOCARBAN 6 mg/g N 20181231 51824-045_e639ed21-925a-4ceb-8bf2-621dc222fc2f 51824-045 HUMAN OTC DRUG CareAll Medicated Chest Rub Camphor, Menthol, Eucalyptus OINTMENT TOPICAL 20140709 OTC MONOGRAPH FINAL part341 New World Imports, Inc CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL .048; .026; .012 g/g; g/g; g/g N 20181231 51824-046_ab0d37c7-bb61-4f0f-9182-19fda4d4d435 51824-046 HUMAN OTC DRUG Freshmint Premium Anticavity Gel Sodium Fluoride PASTE, DENTIFRICE DENTAL 20150101 OTC MONOGRAPH FINAL part355 New World Imports, Inc SODIUM FLUORIDE 2.43 mg/g N 20181231 51824-048_707be41d-1dde-4052-9237-9447cf3db73c 51824-048 HUMAN OTC DRUG Diphenhydramine Diphenhydramine Hydrochloride TABLET, COATED ORAL 20100909 20200801 OTC MONOGRAPH FINAL part341 New World Imports, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 51824-049_861c66c2-834b-475d-9d1b-9695fa4d9df8 51824-049 HUMAN OTC DRUG CareALL Non Aspirin Extra Strength Acetaminophen TABLET ORAL 20150917 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN 500 mg/1 N 20181231 51824-050_271015e7-a85c-448e-bb08-84f15bd4327e 51824-050 HUMAN OTC DRUG CAREALL Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20160311 OTC MONOGRAPH NOT FINAL part348 New World Imports, Inc HYDROCORTISONE ACETATE 1 g/g N 20181231 51824-052_f0799a63-9e17-4806-b59b-aa18aea4b55f 51824-052 HUMAN OTC DRUG CareALL Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate OINTMENT TOPICAL 20160315 OTC MONOGRAPH FINAL part333B New World Imports, Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 51824-053_230e3297-af41-4a3a-8d52-dc92d7319a07 51824-053 HUMAN OTC DRUG Freshmint Sensitive Potassium Nitrate and Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100916 OTC MONOGRAPH NOT FINAL part356 New World Imports, Inc SODIUM FLUORIDE; POTASSIUM NITRATE 2.4; 50 mg/g; mg/g N 20181231 51824-054_c6a2d710-46d7-425e-ad1e-e945ec66d6a8 51824-054 HUMAN OTC DRUG CAREALL Senna-S Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20160418 OTC MONOGRAPH NOT FINAL part334 New World Imports, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 51824-055_b81ed0f0-7c40-4843-9cba-fd967afea0c7 51824-055 HUMAN OTC DRUG CAREALL Aspirin Aspirin TABLET, COATED ORAL 20160301 OTC MONOGRAPH FINAL part343 New World Imports, Inc ASPIRIN 81 mg/1 N 20181231 51824-056_e6dd7625-f965-4c77-8bc4-649d14dfc623 51824-056 HUMAN OTC DRUG CAREALL Diphenhydramine Diphenhydramine Hydrochloride TABLET, COATED ORAL 20160428 OTC MONOGRAPH FINAL part341 New World Imports, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 51824-057_08635a42-c749-421f-8b3c-8a99cc0176e2 51824-057 HUMAN OTC DRUG CAREALL Aspirin Aspirin TABLET, CHEWABLE ORAL 20160329 OTC MONOGRAPH FINAL part343 New World Imports, Inc ASPIRIN 81 mg/1 N 20181231 51824-058_741276e3-24db-4794-95c1-dde5a8810f76 51824-058 HUMAN OTC DRUG CAREALL Sennosides Sennosides TABLET ORAL 20160418 OTC MONOGRAPH NOT FINAL part334 New World Imports, Inc SENNOSIDES A AND B 8.6 mg/1 N 20181231 51824-059_0e90f13f-1bda-47ee-a271-326bbae1313c 51824-059 HUMAN OTC DRUG CAREALL Non-Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20170501 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 51824-060_559bf97d-255d-45c1-901b-267957eb2d07 51824-060 HUMAN OTC DRUG CareALL Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20160415 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN 500 mg/1 N 20181231 51824-061_8fb5e642-6bb5-4321-a760-6fcb36761985 51824-061 HUMAN OTC DRUG CareALL Acetaminophen Acetaminophen TABLET ORAL 20160415 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN 325 mg/1 N 20181231 51824-062_5055eb69-1dc7-4e42-b4a6-5451e13c53ad 51824-062 HUMAN OTC DRUG CAREALL Ibuprofen Ibuprofen TABLET ORAL 20160315 OTC MONOGRAPH NOT FINAL part343 New World Imports IBUPROFEN 200 mg/1 N 20181231 51824-063_595320ca-b823-48a5-8d87-225a565b296e 51824-063 HUMAN OTC DRUG CAREALL Clotrimazole Clotrimazole CREAM TOPICAL 20160321 OTC MONOGRAPH FINAL part333C New World Imports, Inc CLOTRIMAZOLE 1 g/g N 20181231 51824-064_f299069b-470d-4f26-88c9-5e0b239dbe37 51824-064 HUMAN OTC DRUG CAREALL Ibuprofen Ibuprofen TABLET ORAL 20170811 OTC MONOGRAPH NOT FINAL part343 New World Imports IBUPROFEN 200 mg/1 N 20181231 51824-164_8e07de78-91bb-47d2-9586-6521912cbca6 51824-164 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 20110831 20190801 OTC MONOGRAPH FINAL part343 New World Imports, Inc ASPIRIN 81 mg/1 N 20181231 51824-217_8b26d423-ee35-49ac-a377-39241986b68d 51824-217 HUMAN OTC DRUG Sennosides Sennosides TABLET ORAL 20100910 OTC MONOGRAPH NOT FINAL part334 New World Imports, Inc SENNOSIDES A AND B 8.6 mg/1 N 20181231 51824-267_8ee2ede7-d97c-4a10-9215-4ed1103626a8 51824-267 HUMAN OTC DRUG Non-Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20120901 20200801 OTC MONOGRAPH NOT FINAL part343 New World Imports, Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 51824-423_6fb133d2-ce91-4ca5-af5a-99d6e8bd6c20 51824-423 HUMAN OTC DRUG Artifical Tears Glycerin, Hypromellose, Polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20111101 OTC MONOGRAPH FINAL part349 New World Imports, Inc GLYCERIN; HYPROMELLOSE 2910 (15 MPA.S); POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL N 20181231 51824-473_6066a1c4-9443-4334-947f-8e9355bbe986 51824-473 HUMAN OTC DRUG Freshmint Anticavity Flouride Toothpaste Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20100916 OTC MONOGRAPH FINAL part355 New World Imports, Inc SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 51824-474_340a2e45-378e-44df-8cb4-e91e4b56dc56 51824-474 HUMAN OTC DRUG Freshmint Anticavity Fluoride Toothpaste Sodium Fluoride GEL, DENTIFRICE DENTAL 20100917 OTC MONOGRAPH FINAL part355 New World Imports, Inc SODIUM FLUORIDE 2.2 mg/g N 20181231 51824-547_edba1216-928a-4489-abc8-8f68a3e8f86e 51824-547 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20110125 20190801 OTC MONOGRAPH FINAL part343 New World Imports, Inc ASPIRIN 81 mg/1 N 20181231 51824-600_00834bb3-58b1-4a40-ab67-e7a5a94767ba 51824-600 HUMAN OTC DRUG freshscent Anti-Bacterial TRICLOSAN SOAP TOPICAL 20130102 20190601 OTC MONOGRAPH NOT FINAL part333E New World Imports TRICLOSAN .3 g/100g N 20181231 51830-019_944084b6-7eb0-42fd-8f40-5b22812e1001 51830-019 HUMAN OTC DRUG Lightening Day Cream DICAPRYLYL CARBONATE CREAM TOPICAL 20120718 UNAPPROVED DRUG OTHER LANGE SAS POLYETHYLENE GLYCOL 400 2.5 mg/50mg E 20171231 51830-020_618e21fc-0327-4292-a3a5-4ecfa0e31369 51830-020 HUMAN OTC DRUG Lightening Night Cream Ethyl Macadamiate CREAM TOPICAL 20120718 UNAPPROVED DRUG OTHER LANGE SAS ETHYL MACADAMIATE 1 mg/50mg E 20171231 51830-022_d2f49e5c-313e-4646-b0ea-3bdd2c396f49 51830-022 HUMAN OTC DRUG Lightening Serum Dicaprylyl Ether CREAM TOPICAL 20120718 UNAPPROVED DRUG OTHER Lange SAS CYCLOMETHICONE 5 .35 mg/20mg E 20171231 51830-023_c3da5b4a-4ab9-42ac-844f-9f1fbc0ba607 51830-023 HUMAN OTC DRUG Dark Spot Corrector POLYETHYLENE GLYCOL 400 CREAM TOPICAL 20120917 UNAPPROVED DRUG OTHER LANGE SAS POLYETHYLENE GLYCOL 400 .3 mg/15mg E 20171231 51830-030_c63a8bd4-f5e9-4e6b-8e1c-f8a951b64bd8 51830-030 HUMAN OTC DRUG Lift-me day cream with Anti-Ageing and Regenerative Silicium - UV Filters Octinoxate, Avobenzone, Oxybenzone CREAM TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 LANGE SAS OCTINOXATE; AVOBENZONE; OXYBENZONE 3.25; 1.5; 1.25 mL/50mL; mL/50mL; mL/50mL E 20171231 51830-052_ab4c5085-ea1a-446b-8c44-81d3599f84a7 51830-052 HUMAN OTC DRUG Perfect Me Serum Salicylic Acid CREAM TOPICAL 20120718 UNAPPROVED DRUG OTHER Lange SAS SALICYLIC ACID 1 mg/20mg E 20171231 51830-053_0867bfc3-a975-46d2-bd24-6fd33536b9fe 51830-053 HUMAN OTC DRUG Cleansing Foaming Gel Acne Pro Skin ZINC PIDOLATE GEL TOPICAL 20120718 OTC MONOGRAPH NOT FINAL part333D LANGE SAS ZINC PIDOLATE; SALICYLIC ACID; IRIS GERMANICA VAR. FLORENTINA ROOT .072; 12; 1.8 mg/120mg; mg/120mg; mg/120mg E 20171231 51830-054_23c8b813-23a3-4a5b-bad3-e3a7d8d19896 51830-054 HUMAN OTC DRUG Preparing Tonic Salicylic Acid LOTION TOPICAL 20120718 OTC MONOGRAPH NOT FINAL part333D Lange SAS SALICYLIC ACID 1.8 mg/180mg E 20171231 51849-1250_53fc5bec-808b-470d-ae08-14e1f3356581 51849-1250 HUMAN OTC DRUG JIDESHENG HEMORRHOID WITCH HAZEL, CARTHAMUS TINCTORIS FLOWER BED, CORYDALIS AMBIGUA TUBER, LONGICERA CAPRIFOLIUM CAPRIFOLIUM FLOWER OINTMENT RECTAL 20100515 OTC MONOGRAPH FINAL part346 NANTONG JIDESHENG BIOLOGY HEALTH CARE PRODUCTS CO LTD WITCH HAZEL; CARTHAMUS TINCTORIUS FLOWER BUD; CORYDALIS AMBIGUA TUBER; LONICERA CAPRIFOLIUM FLOWER 12.5; 12.5; 12.5; 5 mg/1000mg; mg/1000mg; mg/1000mg; mg/1000mg E 20171231 51849-3574_b75c2d62-eb35-42f3-ab6d-23051bc9fe77 51849-3574 HUMAN OTC DRUG JiDeSheng Clotrimazole GEL TOPICAL 20101023 OTC MONOGRAPH FINAL part333C Nantong Jidesheng Biology Health Care Products Co., Ltd. CLOTRIMAZOLE 1 g/100g E 20171231 51850-002_93faf383-9a3a-410c-9aca-5960e990543e 51850-002 HUMAN OTC DRUG LivTac Ruta Graveolens SALVE TOPICAL 20100901 UNAPPROVED HOMEOPATHIC LivDerma Inc. RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/50g E 20171231 51852-100_cf361d71-0209-4d1d-af56-c29648c5d3fd 51852-100 HUMAN OTC DRUG First Aid Triple Antibiotic and Pain Relief Maximum Strength Bacitracin Zinc, Neomycin, Polymyxin B Sulfate, Pramoxine Hydrocloride OINTMENT TOPICAL 20101101 OTC MONOGRAPH FINAL part333B LIFElabs, a Division of Atico International USA, INC. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g E 20171231 51852-101_551c24bc-8859-4a83-b32b-1237329a7ffb 51852-101 HUMAN OTC DRUG Oral Analgesic Maximum Strength Benzocaine GEL TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part356 LIFElabs, a Division of Atico International USA, INC. BENZOCAINE 200 mg/g E 20171231 51852-102_e199cc9f-e38c-43e9-a515-f868abcf931b 51852-102 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20101101 OTC MONOGRAPH FINAL part333C LIFElabs, a Division of Atico International, USA, INC. TOLNAFTATE 10 mg/g E 20171231 51852-103_a523aa80-9557-40c6-b522-00471cdf364c 51852-103 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20101101 OTC MONOGRAPH FINAL part333C LIFElabs, a Division of Atico International USA, INC. CLOTRIMAZOLE 10 mg/g E 20171231 51852-104_3dcac1b9-0103-4c58-b3d0-df808a739262 51852-104 HUMAN OTC DRUG Muscle and Joint Vanishing Scent Fast Penetrating Menthol GEL TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part348 LIFElabs, a Division of Atico International USA, INC. MENTHOL 25 mg/g E 20171231 51852-105_f8376280-0476-4dfd-8be8-64312266def0 51852-105 HUMAN OTC DRUG Muscle Rub Maximum Strength Methyl Salicylate, Menthol, Camphor CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part348 LIFElabs, a Division of Atico International USA, INC. METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 300; 100; 40 mg/g; mg/g; mg/g E 20171231 51861-010_b49861d3-b5b4-45d4-be01-4f7293d9b90f 51861-010 HUMAN OTC DRUG SENSE Daytime Protective Broad Spectrum SPF 15 OCTINOXATE, OXYBENZONE, AVOBENZONE EMULSION TOPICAL 20120328 OTC MONOGRAPH FINAL part352 USANA Health Sciences, Inc. OCTINOXATE; OXYBENZONE; AVOBENZONE 7.5; 3; 2 mL/100mL; mL/100mL; mL/100mL E 20171231 51861-050_4d9b12d3-72d2-6ade-e054-00144ff8d46c 51861-050 HUMAN OTC DRUG Protective Day AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 USANA Health Sciences, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 10; 7.5; 2 g/100g; g/100g; g/100g; g/100g N 20181231 51861-050_53322920-bbfd-7486-e054-00144ff8d46c 51861-050 HUMAN OTC DRUG Protective Day AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20170629 OTC MONOGRAPH NOT FINAL part352 USANA Health Sciences, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 10; 7.5; 2 g/100g; g/100g; g/100g; g/100g N 20181231 51861-060_4d9ac5e4-267c-71f7-e054-00144ff8d46c 51861-060 HUMAN OTC DRUG Protective Day AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE LOTION TOPICAL 20170801 OTC MONOGRAPH FINAL part352 USANA Health Sciences, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 30; 100; 75; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 51861-102_c867b7b6-7ef9-4d05-8927-1bdebe31229c 51861-102 HUMAN OTC DRUG PRENATAL CHELATED MINERAL CALCIUM CITRATE, CALCIUM CARBONATE, POTASSIUM IODIDE, MAGNESIUM CITRATE, ZINC CITRATE, COPPER GLUCONATE, and FERROUS FUMARATE TABLET ORAL 20120411 UNAPPROVED DRUG OTHER USANA Health Sciences, Inc. CALCIUM CITRATE; CALCIUM CARBONATE; POTASSIUM IODIDE; MAGNESIUM CITRATE; ZINC CITRATE; COPPER GLUCONATE; FERROUS FUMARATE 32.5; 30; 75; 75; 5; .5; 7 mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 E 20171231 51861-103_68124116-64a2-4192-a705-8e728855e94b 51861-103 HUMAN OTC DRUG Prenatal Mega Antioxidant VITAMIN A, ASCORBIC ACID, VITAMIN D, .ALPHA.-TOCOPHEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, BIOTIN, and CALCIUM PANTOTHENATE TABLET ORAL 20120411 UNAPPROVED DRUG OTHER USANA Health Services, Inc. VITAMIN A; ASCORBIC ACID; VITAMIN D; .ALPHA.-TOCOPHEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; BIOTIN; CALCIUM PANTOTHENATE 3750; 325; 450; 100; 6.75; 6.75; 10; 8; 50; 250; 75; 22.5 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1 E 20171231 51862-005_9ef855ed-9897-4d05-9490-29a004a2e026 51862-005 HUMAN PRESCRIPTION DRUG Dofetilide Dofetilide CAPSULE ORAL 20160607 ANDA ANDA207058 Mayne Pharma Inc. DOFETILIDE .5 mg/1 Antiarrhythmic [EPC] N 20181231 51862-007_2a2924ab-019a-4320-8c2e-55928f267ba3 51862-007 HUMAN PRESCRIPTION DRUG MICROGESTIN 1/20 norethindrone acetate and ethinyl estradiol TABLET ORAL 20160805 NDA AUTHORIZED GENERIC NDA017876 Mayne Pharma Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; 20 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 51862-012_2a2924ab-019a-4320-8c2e-55928f267ba3 51862-012 HUMAN PRESCRIPTION DRUG MICROGESTIN Fe 1/20 norethindrone acetate and ethinyl estradiol and ferrous fumarate KIT 20160805 NDA AUTHORIZED GENERIC NDA017354 Mayne Pharma Inc. N 20181231 51862-015_37a32e74-3ebf-2af7-e054-00144ff8d46c 51862-015 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20160718 ANDA ANDA073553 Mayne Pharma Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51862-016_37a32e74-3ebf-2af7-e054-00144ff8d46c 51862-016 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20160718 ANDA ANDA073554 Mayne Pharma Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51862-017_37a32e74-3ebf-2af7-e054-00144ff8d46c 51862-017 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20160718 ANDA ANDA073555 Mayne Pharma Inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51862-018_37a32e74-3ebf-2af7-e054-00144ff8d46c 51862-018 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20160718 ANDA ANDA073556 Mayne Pharma Inc. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51862-025_9ef855ed-9897-4d05-9490-29a004a2e026 51862-025 HUMAN PRESCRIPTION DRUG Dofetilide Dofetilide CAPSULE ORAL 20160607 ANDA ANDA207058 Mayne Pharma Inc. DOFETILIDE .25 mg/1 Antiarrhythmic [EPC] N 20181231 51862-028_cf8bc65f-dc0d-4557-a3df-596431e38a86 51862-028 HUMAN PRESCRIPTION DRUG Lutera levonorgestrel and ethinyl estradiol KIT 20160803 ANDA ANDA076625 Mayne Pharma Inc. N 20181231 51862-036_e7b8af18-5840-4433-a74b-c2686f4891b1 51862-036 HUMAN PRESCRIPTION DRUG Zarah Drospirenone and Ethinyl Estradiol KIT 20160803 ANDA ANDA090081 Mayne Pharma Inc. N 20181231 51862-045_5a1ffc70-76aa-43fe-9b7d-45017ed8f7fe 51862-045 HUMAN PRESCRIPTION DRUG Amethia Lo levonorgestrel/ethinyl estradiol and ethinyl estradiol KIT 20161110 NDA AUTHORIZED GENERIC NDA022262 Mayne Pharma Inc. N 20181231 51862-047_a655b743-5d14-43f2-9618-d804e8e751d5 51862-047 HUMAN PRESCRIPTION DRUG Amethia ETHINYL ESTRADIOL and LEVONORGESTREL KIT 20161012 ANDA ANDA078834 Mayne Pharma Inc N 20181231 51862-062_e545f4b0-6879-4bdf-93c0-d0165bc14615 51862-062 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071134 Mayne Pharma DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51862-063_e545f4b0-6879-4bdf-93c0-d0165bc14615 51862-063 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071135 Mayne Pharma DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51862-064_e545f4b0-6879-4bdf-93c0-d0165bc14615 51862-064 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071136 Mayne Pharma DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51862-069_7bc320de-4d71-4b89-a362-92c80646718a 51862-069 HUMAN PRESCRIPTION DRUG Estazolam Estazolam TABLET ORAL 20160803 ANDA ANDA074921 Mayne Pharma ESTAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51862-070_7bc320de-4d71-4b89-a362-92c80646718a 51862-070 HUMAN PRESCRIPTION DRUG Estazolam Estazolam TABLET ORAL 20160803 ANDA ANDA074921 Mayne Pharma ESTAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 51862-072_eb47c324-269b-426b-a290-f2ca985edb5e 51862-072 HUMAN PRESCRIPTION DRUG Azurette Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20161114 ANDA ANDA075863 Mayne Pharma Inc. N 20181231 51862-077_e3260bd1-aa3e-4891-a855-72916fee76c2 51862-077 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA and LEVODOPA TABLET ORAL 20161024 ANDA ANDA073618 Mayne Pharma Inc CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 51862-079_739d8e19-14a6-46cc-bfa6-8321dece9c1e 51862-079 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20160718 ANDA ANDA074260 Mayne Pharma Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 51862-080_739d8e19-14a6-46cc-bfa6-8321dece9c1e 51862-080 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20160718 ANDA ANDA074260 Mayne Pharma Inc. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 51862-083_1dd2cff6-3b64-4245-9d14-1002b74f2732 51862-083 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20161010 ANDA ANDA206413 Mayne Pharma Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 51862-084_1dd2cff6-3b64-4245-9d14-1002b74f2732 51862-084 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20161010 ANDA ANDA206413 Mayne Pharma Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 51862-085_1dd2cff6-3b64-4245-9d14-1002b74f2732 51862-085 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20161010 ANDA ANDA206413 Mayne Pharma Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 51862-086_1dd2cff6-3b64-4245-9d14-1002b74f2732 51862-086 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20161010 ANDA ANDA206413 Mayne Pharma Inc. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 51862-087_1dd2cff6-3b64-4245-9d14-1002b74f2732 51862-087 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20161010 ANDA ANDA206413 Mayne Pharma Inc. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 51862-088_1dd2cff6-3b64-4245-9d14-1002b74f2732 51862-088 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20161010 ANDA ANDA206413 Mayne Pharma Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 51862-093_03aeef71-6499-48ff-aad2-ba8dbc53b436 51862-093 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 20160803 ANDA ANDA070173 Mayne Pharma Inc. DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] N 20191231 51862-094_03aeef71-6499-48ff-aad2-ba8dbc53b436 51862-094 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 20160803 ANDA ANDA070173 Mayne Pharma Inc. DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] N 20191231 51862-097_074828fd-508d-47c8-896a-345ed71e85f6 51862-097 HUMAN PRESCRIPTION DRUG Levora levonorgestrel and ethinyl estradiol KIT 20160803 ANDA ANDA073594 Mayne Pharma Inc. N 20181231 51862-100_652dfa39-21a6-4864-b5d1-24b419b77185 51862-100 HUMAN PRESCRIPTION DRUG Errin Norethindrone TABLET ORAL 20160803 ANDA ANDA076225 Mayne Pharma Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 51862-102_7e17fd36-c127-4367-a09c-527f9debbce3 51862-102 HUMAN PRESCRIPTION DRUG Camila Norethindrone TABLET ORAL 20160803 ANDA ANDA076177 Mayne Pharma Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 51862-125_9ef855ed-9897-4d05-9490-29a004a2e026 51862-125 HUMAN PRESCRIPTION DRUG Dofetilide Dofetilide CAPSULE ORAL 20160607 ANDA ANDA207058 Mayne Pharma Inc. DOFETILIDE .125 mg/1 Antiarrhythmic [EPC] N 20181231 51862-135_d828272f-55c3-40e7-96e4-9e3b83c70a55 51862-135 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride POWDER ORAL 20150316 20200430 UNAPPROVED DRUG OTHER Mayne Pharma Inc. POTASSIUM CHLORIDE 20 meq/1.5g Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 51862-146_285f771f-9083-4b67-b672-8e5748dddc6c 51862-146 HUMAN PRESCRIPTION DRUG Selegiline Hydrochloride Selegiline Hydrochloride TABLET ORAL 20140524 20190731 ANDA ANDA074912 Mayne Pharma SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20191231 51862-151_710f2d40-e160-44c7-93b9-b377f37b5106 51862-151 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Multi-Vitamin With Fluoride TABLET, CHEWABLE ORAL 20110521 20190430 UNAPPROVED DRUG OTHER Mayne Pharma Inc VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5; .25 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 51862-152_ca899f4b-5abc-493b-b56c-004a1405c240 51862-152 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Multi-Vitamin With Fluoride TABLET, CHEWABLE ORAL 20110521 20190630 UNAPPROVED DRUG OTHER Mayne Pharma Inc VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5; .5 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 51862-153_294604ce-382f-4f68-be49-bfb8ce62d21f 51862-153 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Multi-Vitamin With Fluoride TABLET, CHEWABLE ORAL 20110521 20191031 UNAPPROVED DRUG OTHER Mayne Pharma Inc VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; SODIUM FLUORIDE 2500; 60; 400; 15; 1.05; 1.2; 13.5; 1.05; .3; 4.5; 1 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 51862-154_74508cf8-2bf4-4824-a450-c1cce2bc4a22 51862-154 HUMAN PRESCRIPTION DRUG Amiodarone HCl Amiodarone Hydrochloride TABLET ORAL 20170101 ANDA ANDA077069 Mayne Pharma Inc. AMIODARONE HYDROCHLORIDE 100 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 51862-155_74508cf8-2bf4-4824-a450-c1cce2bc4a22 51862-155 HUMAN PRESCRIPTION DRUG Amiodarone HCl Amiodarone Hydrochloride TABLET ORAL 20130101 ANDA ANDA077069 Mayne Pharma Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 51862-156_74508cf8-2bf4-4824-a450-c1cce2bc4a22 51862-156 HUMAN PRESCRIPTION DRUG Amiodarone HCl Amiodarone Hydrochloride TABLET ORAL 20130101 ANDA ANDA077069 Mayne Pharma Inc. AMIODARONE HYDROCHLORIDE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 51862-161_f642746b-ba65-4210-904f-eaad51440524 51862-161 HUMAN PRESCRIPTION DRUG Multi Vitamin and Fluoride Multi Vitamin and Fluoride SOLUTION/ DROPS ORAL 20110521 20191031 UNAPPROVED DRUG OTHER Mayne Pharma Inc VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 8; .4; 2; .25 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 51862-162_4b167374-e94b-46d7-b439-802b7782250a 51862-162 HUMAN PRESCRIPTION DRUG Multi Vitamin and Fluoride Multivitamin and Fluoride SOLUTION/ DROPS ORAL 20110521 20191031 UNAPPROVED DRUG OTHER Mayne Pharma Inc VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 8; .4; 2; .5 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 51862-163_5a272b99-11ab-4e75-a3df-a4313df90167 51862-163 HUMAN PRESCRIPTION DRUG Multi Vitamin, Iron and Fluoride Multi Vitamin, Iron and Fluoride SOLUTION/ DROPS ORAL 20110521 20191031 UNAPPROVED DRUG OTHER Mayne Pharma Inc VITAMIN A PALMITATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; ASCORBIC ACID; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; IRON; SODIUM FLUORIDE 1500; 400; 5; 35; .5; .6; 8; .4; 10; .25 [iU]/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20181231 51862-164_81d3c300-0572-487a-a6fe-0dd9286cb53e 51862-164 HUMAN PRESCRIPTION DRUG VITAMINS A, C, D and FLUORIDE VITAMINS A, C, D and FLUORIDE SOLUTION/ DROPS ORAL 20110521 20191031 UNAPPROVED DRUG OTHER Mayne Pharma Inc. VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; SODIUM FLUORIDE 1500; 35; 400; .25 [iU]/mL; mg/mL; [iU]/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 51862-165_167bb408-1cee-43ed-b2f1-7061c5f9fde7 51862-165 HUMAN PRESCRIPTION DRUG Sodium Fluoride Sodium Fluoride SOLUTION/ DROPS ORAL 20110521 20190930 UNAPPROVED DRUG OTHER Mayne Pharma Inc SODIUM FLUORIDE .5 mg/mL N 20181231 51862-171_97c0b2dd-35e5-4fee-b068-3d9b3fbbac4d 51862-171 HUMAN PRESCRIPTION DRUG Fluoride Fluoride TABLET, CHEWABLE ORAL 20110521 20200331 UNAPPROVED DRUG OTHER Mayne Pharma Inc SODIUM FLUORIDE .5 mg/1 N 20181231 51862-172_28d952e7-7caa-492f-a1f5-7a39098da55e 51862-172 HUMAN PRESCRIPTION DRUG Fluoride Fluoride TABLET, CHEWABLE ORAL 20110521 20200331 UNAPPROVED DRUG OTHER Mayne Pharma Inc SODIUM FLUORIDE 1 mg/1 N 20181231 51862-175_66612c80-f251-449a-98c2-eb7b67a7af42 51862-175 HUMAN PRESCRIPTION DRUG UR N-C Urinary Antiseptic Hyoscyamine Sulfate, Methenamine, Phenyl Salicylate, Sodium Phosphate Monobasic, Methylene Blue TABLET ORAL 20110521 20180430 UNAPPROVED DRUG OTHER Mayne Pharma Inc. HYOSCYAMINE SULFATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHENAMINE; METHYLENE BLUE .12; 40.8; 36.2; 81.6; 10.8 mg/1; mg/1; mg/1; mg/1; mg/1 Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 51862-179_dd586ce2-ecad-4ef4-882c-825e3e6880fa 51862-179 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine CAPSULE ORAL 20120416 ANDA ANDA089007 Mayne Pharma Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 51862-180_920da7e2-796f-41c2-a6dc-f01a90537d90 51862-180 HUMAN OTC DRUG Pramoxine hydrochloride Pramoxine hydrochloride AEROSOL, FOAM TOPICAL 20111031 OTC MONOGRAPH FINAL part346 Mayne Pharma PRAMOXINE HYDROCHLORIDE 10 mg/g N 20181231 51862-181_16eb680b-fd40-44fd-a115-41a868e7f03e 51862-181 HUMAN PRESCRIPTION DRUG Urea Urea GEL TOPICAL 20111028 20190331 UNAPPROVED DRUG OTHER Mayne Pharma Inc. UREA 450 mg/g N 20181231 51862-182_312947dd-0a5a-44fd-ae3c-8356a16e0ae2 51862-182 HUMAN PRESCRIPTION DRUG UREA UREA CREAM TOPICAL 20111007 20180731 UNAPPROVED DRUG OTHER Mayne Pharma Inc. UREA 450 mg/g N 20181231 51862-185_c4254486-7d8b-4c42-9181-cdc558e17fc5 51862-185 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161101 ANDA ANDA205386 Mayne Pharma Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 51862-186_c4254486-7d8b-4c42-9181-cdc558e17fc5 51862-186 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161101 ANDA ANDA205386 Mayne Pharma Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 51862-187_c4254486-7d8b-4c42-9181-cdc558e17fc5 51862-187 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161101 ANDA ANDA205386 Mayne Pharma Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 51862-188_c4254486-7d8b-4c42-9181-cdc558e17fc5 51862-188 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161101 ANDA ANDA205386 Mayne Pharma Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 51862-194_6110a6df-7c93-48c8-9092-50ce76cc57b2 51862-194 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160803 ANDA ANDA065154 Mayne Pharma Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51862-215_a62a214e-925d-4f56-ae22-2f7cd0b7b560 51862-215 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Mayne Pharma Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 51862-216_a62a214e-925d-4f56-ae22-2f7cd0b7b560 51862-216 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Mayne Pharma Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 51862-217_a62a214e-925d-4f56-ae22-2f7cd0b7b560 51862-217 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Mayne Pharma Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 51862-227_134b9831-bb50-4720-8e11-61aa70cb06ab 51862-227 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 20200630 ANDA ANDA090118 Mayne Pharma Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 51862-228_134b9831-bb50-4720-8e11-61aa70cb06ab 51862-228 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 20200630 ANDA ANDA090118 Mayne Pharma Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 51862-229_134b9831-bb50-4720-8e11-61aa70cb06ab 51862-229 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 20200531 ANDA ANDA090118 Mayne Pharma Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 51862-238_d9056837-a58e-4c7f-8ae5-09d1642310d0 51862-238 HUMAN PRESCRIPTION DRUG Caziant Triphasic Regimen Desogestrel and Ethinyl Estradiol KIT 20160803 ANDA ANDA076455 Mayne Pharma Inc. N 20181231 51862-240_0e48f8d5-896c-4bb6-a1a0-82cdff39eb13 51862-240 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20180102 ANDA ANDA075389 Mayne Pharma Inc. AMIODARONE HYDROCHLORIDE 100 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 51862-242_0e48f8d5-896c-4bb6-a1a0-82cdff39eb13 51862-242 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20180102 ANDA ANDA075389 Mayne Pharma Inc. AMIODARONE HYDROCHLORIDE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 51862-260_9c4c9aa1-2212-4517-ba7c-ee1c9c83ee0e 51862-260 HUMAN PRESCRIPTION DRUG Zovia 1/35 Ethynodiol Diacetate and Ethinyl Estradiol KIT 20160718 ANDA ANDA076785 Mayne Pharma Inc. N 20181231 51862-263_f240f604-db61-4474-aa88-a38bb7f8a878 51862-263 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (LA) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160803 ANDA ANDA078458 Mayne Pharma METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 51862-264_f240f604-db61-4474-aa88-a38bb7f8a878 51862-264 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (LA) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160803 ANDA ANDA078458 Mayne Pharma METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 51862-265_f240f604-db61-4474-aa88-a38bb7f8a878 51862-265 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (LA) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160803 ANDA ANDA078458 Mayne Pharma METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 51862-267_f240f604-db61-4474-aa88-a38bb7f8a878 51862-267 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (LA) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170220 ANDA ANDA078458 Mayne Pharma METHYLPHENIDATE HYDROCHLORIDE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 51862-271_744f757c-85aa-4629-9018-3955cbe0cdc9 51862-271 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20160803 ANDA ANDA203807 Mayne Pharma CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 51862-272_744f757c-85aa-4629-9018-3955cbe0cdc9 51862-272 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20171026 ANDA ANDA203807 Mayne Pharma CLOZAPINE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 51862-273_744f757c-85aa-4629-9018-3955cbe0cdc9 51862-273 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20160803 ANDA ANDA203807 Mayne Pharma CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 51862-274_744f757c-85aa-4629-9018-3955cbe0cdc9 51862-274 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20171026 ANDA ANDA203807 Mayne Pharma CLOZAPINE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 51862-279_2a2924ab-019a-4320-8c2e-55928f267ba3 51862-279 HUMAN PRESCRIPTION DRUG MICROGESTIN 1.5/30 norethindrone acetate and ethinyl estradiol TABLET ORAL 20160805 NDA AUTHORIZED GENERIC NDA017875 Mayne Pharma Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1.5; 30 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 51862-284_edeaaeb6-c806-4015-98ec-b9acf508f3ec 51862-284 HUMAN PRESCRIPTION DRUG Tilia Fe Norethindrone Acetate and Ethinyl Estradiol KIT ORAL 20160805 NDA NDA020130 Mayne Pharma Inc. N 20181231 51862-292_2a2924ab-019a-4320-8c2e-55928f267ba3 51862-292 HUMAN PRESCRIPTION DRUG MICROGESTIN Fe 1.5/30 norethindrone acetate and ethinyl estradiol and ferrous fumarate KIT 20160805 NDA AUTHORIZED GENERIC NDA017355 Mayne Pharma Inc. N 20181231 51862-295_36320220-2d8d-4854-84a4-924ae33ffb81 51862-295 HUMAN PRESCRIPTION DRUG FABIOR tazarotene AEROSOL, FOAM TOPICAL 20170310 NDA NDA202428 Mayne Pharma LLC TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 51862-314_b3c9d169-abfa-49b7-a7f0-5a7ee4636cec 51862-314 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20171002 ANDA ANDA077062 Mayne Pharma FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 51862-315_b3c9d169-abfa-49b7-a7f0-5a7ee4636cec 51862-315 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20171002 ANDA ANDA077062 Mayne Pharma FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 51862-316_b3c9d169-abfa-49b7-a7f0-5a7ee4636cec 51862-316 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20171002 ANDA ANDA077062 Mayne Pharma FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 51862-317_b3c9d169-abfa-49b7-a7f0-5a7ee4636cec 51862-317 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20171002 ANDA ANDA077062 Mayne Pharma FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 51862-318_b4a2f414-0912-4fae-8116-78e9cd23af10 51862-318 HUMAN PRESCRIPTION DRUG Necon (28 Day Regimen) Norethindrone and Ethinyl Estradiol KIT 20160718 ANDA ANDA072695 Mayne Pharma Inc. N 20181231 51862-320_0450d0ca-80df-40fc-b8f0-339fd5d05eb9 51862-320 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20180101 ANDA ANDA090097 Mayne Pharma LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20191231 51862-321_0450d0ca-80df-40fc-b8f0-339fd5d05eb9 51862-321 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20180101 ANDA ANDA090097 Mayne Pharma LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20191231 51862-322_0450d0ca-80df-40fc-b8f0-339fd5d05eb9 51862-322 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20180101 ANDA ANDA090097 Mayne Pharma LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20191231 51862-332_8e695112-128a-46cd-ae79-d7e49f5dffba 51862-332 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20160803 ANDA ANDA040197 Mayne Pharma Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 51862-333_8e695112-128a-46cd-ae79-d7e49f5dffba 51862-333 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20160803 ANDA ANDA040197 Mayne Pharma Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 51862-334_8e695112-128a-46cd-ae79-d7e49f5dffba 51862-334 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20160803 ANDA ANDA040197 Mayne Pharma Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 51862-344_1e18859e-98bd-4bee-8112-9a359cfee78b 51862-344 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20160805 ANDA ANDA203901 Mayne Pharma Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 51862-345_1e18859e-98bd-4bee-8112-9a359cfee78b 51862-345 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20160805 ANDA ANDA203901 Mayne Pharma Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 51862-346_1e18859e-98bd-4bee-8112-9a359cfee78b 51862-346 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20160805 ANDA ANDA203901 Mayne Pharma Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 51862-376_2be531a5-6c91-4eca-a7f3-c55488037365 51862-376 HUMAN PRESCRIPTION DRUG SORILUX calcipotriene AEROSOL, FOAM TOPICAL 20170411 NDA NDA022563 Mayne Pharma LLC CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 51862-446_73fa5f6b-3d08-49cd-adff-c1010413227d 51862-446 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20160803 ANDA ANDA075797 Mayne Pharma Inc. TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20191231 51862-447_73fa5f6b-3d08-49cd-adff-c1010413227d 51862-447 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20160803 ANDA ANDA075797 Mayne Pharma Inc. TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20191231 51862-449_7ea67957-8b26-4283-b6e7-520218e5cacd 51862-449 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20160718 ANDA ANDA070929 Mayne Pharma Inc. TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 51862-450_7ea67957-8b26-4283-b6e7-520218e5cacd 51862-450 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20160718 ANDA ANDA070929 Mayne Pharma Inc. TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 51862-453_5df580f6-6678-422c-b4a6-5f87e1b3de6d 51862-453 HUMAN PRESCRIPTION DRUG Clonidine CLONIDINE PATCH, EXTENDED RELEASE TRANSDERMAL 20160803 ANDA ANDA079090 Mayne Pharma Inc. CLONIDINE .1 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 51862-454_5df580f6-6678-422c-b4a6-5f87e1b3de6d 51862-454 HUMAN PRESCRIPTION DRUG Clonidine CLONIDINE PATCH, EXTENDED RELEASE TRANSDERMAL 20160803 ANDA ANDA079090 Mayne Pharma Inc. CLONIDINE .2 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 51862-455_5df580f6-6678-422c-b4a6-5f87e1b3de6d 51862-455 HUMAN PRESCRIPTION DRUG Clonidine CLONIDINE PATCH, EXTENDED RELEASE TRANSDERMAL 20160803 ANDA ANDA079090 Mayne Pharma Inc. CLONIDINE .3 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 51862-458_7777c2a0-349d-4951-8da9-a336d271dab3 51862-458 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20160718 ANDA ANDA065044 Mayne Pharma Inc. CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51862-460_7777c2a0-349d-4951-8da9-a336d271dab3 51862-460 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20160718 ANDA ANDA065044 Mayne Pharma Inc. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 51862-470_63a11e42-2afa-4b0c-9b99-d2df8e7d8e11 51862-470 HUMAN PRESCRIPTION DRUG Tri-Norinyl Norethindrone and Ethinyl Estradiol KIT 20160803 NDA NDA018977 Mayne Pharma Inc. N 20181231 51862-471_018a2736-cdd8-438d-96cb-115f97378f82 51862-471 HUMAN PRESCRIPTION DRUG Leena Norethindrone and Ethinyl Estradiol KIT 20160803 NDA AUTHORIZED GENERIC NDA018977 Mayne Pharma Inc. N 20181231 51862-486_69130d7a-6ab7-49c7-b889-2f368f7110a7 51862-486 HUMAN PRESCRIPTION DRUG Trimethoprim Trimethoprim TABLET ORAL 20160718 NDA NDA018679 Mayne Pharma TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 51862-494_dde40eee-878b-5358-3d18-e31510bc01f4 51862-494 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20161001 ANDA ANDA073085 Mayne Pharma FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51862-510_c12c8012-f955-44e7-96e8-5d2341af221c 51862-510 HUMAN PRESCRIPTION DRUG Trivora Levonorgestrel and Ethinyl Estradiol KIT 20160803 ANDA ANDA074538 Mayne Pharma Inc. N 20181231 51862-538_adde9439-7399-4706-8237-81ab5658f8f0 51862-538 HUMAN PRESCRIPTION DRUG butalbital and acetaminophen butalbital and acetaminophen TABLET ORAL 20170213 ANDA ANDA207386 Mayne Pharma BUTALBITAL; ACETAMINOPHEN 50; 300 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 51862-540_60a0200a-6641-184b-e053-2991aa0a8be2 51862-540 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 20150828 ANDA ANDA089175 Mayne Pharma BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 51862-545_978497f5-ed35-47ab-bf92-3626bf14aab8 51862-545 HUMAN PRESCRIPTION DRUG SRONYX Levonorgestrel and Ethinyl Estradiol KIT 20160803 ANDA ANDA077681 Mayne Pharma Inc. N 20181231 51862-557_4ea9ed5f-2a33-459f-a90c-0740a0bded2c 51862-557 HUMAN PRESCRIPTION DRUG Doryx doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20150526 NDA NDA050795 Mayne Pharma Inc. DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 51862-558_4ea9ed5f-2a33-459f-a90c-0740a0bded2c 51862-558 HUMAN PRESCRIPTION DRUG Doryx doxycycline hyclate TABLET, DELAYED RELEASE ORAL 20150413 NDA NDA050795 Mayne Pharma Inc. DOXYCYCLINE HYCLATE 200 mg/1 N 20181231 51862-559_1402e295-b1d4-4eab-8aa7-ffa57efe0d03 51862-559 HUMAN PRESCRIPTION DRUG DORYX MPC Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20160701 NDA NDA050795 Mayne Pharma DOXYCYCLINE HYCLATE 120 mg/1 N 20181231 51862-560_1402e295-b1d4-4eab-8aa7-ffa57efe0d03 51862-560 HUMAN PRESCRIPTION DRUG DORYX MPC Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20160701 NDA NDA050795 Mayne Pharma DOXYCYCLINE HYCLATE 60 mg/1 N 20181231 51862-564_e60ac529-6fc7-475f-ac1f-c6ab4ac09f37 51862-564 HUMAN PRESCRIPTION DRUG Low-Ogestrel Norgestrel and Ethinyl Estradiol KIT 20160803 ANDA ANDA075288 Mayne Pharma Inc. N 20181231 51862-582_ca9d376e-c681-4812-8b09-b3f386dd9eda 51862-582 HUMAN PRESCRIPTION DRUG BUDESONIDE (ENTERIC COATED) Budesonide CAPSULE, DELAYED RELEASE PELLETS ORAL 20161025 ANDA ANDA206623 Mayne Pharma Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 51862-585_e98ec25b-0e74-4b6e-8ef0-b57f57006da8 51862-585 HUMAN PRESCRIPTION DRUG LORCET Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161214 ANDA ANDA090118 Mayne Pharma Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 51862-586_e98ec25b-0e74-4b6e-8ef0-b57f57006da8 51862-586 HUMAN PRESCRIPTION DRUG LORCET PLUS Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161214 ANDA ANDA090118 Mayne Pharma Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 51862-587_e98ec25b-0e74-4b6e-8ef0-b57f57006da8 51862-587 HUMAN PRESCRIPTION DRUG LORCET HD Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161214 ANDA ANDA090118 Mayne Pharma Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 51862-695_b3f91970-e695-43a2-850f-502c557053f0 51862-695 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20170614 ANDA ANDA208765 Mayne Pharma Inc. DOXYCYCLINE HYCLATE 75 mg/1 N 20181231 51862-696_b3f91970-e695-43a2-850f-502c557053f0 51862-696 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20170614 ANDA ANDA208765 Mayne Pharma Inc. DOXYCYCLINE HYCLATE 150 mg/1 N 20181231 51862-709_b418d742-5e0b-4586-9d8e-9080e42e2ef4 51862-709 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20160526 NDA AUTHORIZED GENERIC NDA050795 Mayne Pharma DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 51870-000_cec4f1b8-576e-4a58-befe-a0c1c1313443 51870-000 HUMAN OTC DRUG NEXT 1 Anti-bacterial TRICLOCARBAN SOAP TOPICAL 20131031 OTC MONOGRAPH NOT FINAL part333E Keefe Group TRICLOCARBAN 1.5 g/100g E 20171231 51870-001_3c2df051-6e4e-4462-8175-31740a731086 51870-001 HUMAN OTC DRUG Roll On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20120626 OTC MONOGRAPH FINAL part350 Keefe Group ALUMINUM CHLOROHYDRATE 14 mg/100mL N 20181231 51870-002_47558574-5b79-6e95-e054-00144ff8d46c 51870-002 HUMAN OTC DRUG Elementz Pyrithione Zinc SHAMPOO TOPICAL 20170130 OTC MONOGRAPH FINAL part358H Keefe Group PYRITHIONE ZINC 1.2 g/100mL N 20181231 51870-003_5200aee3-7aff-3344-e054-00144ff88e88 51870-003 HUMAN OTC DRUG Next1 Anti-bacterial Deodorant Sport Benzalkonium Chloride SOAP TOPICAL 20170615 OTC MONOGRAPH NOT FINAL part333E Keefe Group BENZALKONIUM CHLORIDE .1 g/100g N 20181231 51870-004_52020245-929a-6413-e054-00144ff88e88 51870-004 HUMAN OTC DRUG Next 1 Anti-bacterial Deodorant Benzalkonium Chloride SOAP TOPICAL 20170615 OTC MONOGRAPH NOT FINAL part333E Keefe Group BENZALKONIUM CHLORIDE .1 g/100g N 20181231 51879-121_5df97283-794c-895f-e053-2991aa0a8ca3 51879-121 HUMAN OTC DRUG Licefreee Sodium chloride GEL TOPICAL 20160430 UNAPPROVED HOMEOPATHIC Tec Laboratories, Inc. SODIUM CHLORIDE 2 [hp_X]/g N 20181231 51879-122_5df884fc-9022-4ff7-e053-2991aa0ad5a5 51879-122 HUMAN OTC DRUG Licefreee Sodium chloride KIT TOPICAL 20160713 UNAPPROVED HOMEOPATHIC Tec Laboratories, Inc. N 20181231 51879-161_5e81c776-775c-4060-e053-2991aa0a918f 51879-161 HUMAN OTC DRUG Tecnu Rash Relief Grindelia Robusta, Calendula officinalis SPRAY TOPICAL 20110114 UNAPPROVED HOMEOPATHIC Tec Laboratories, Inc. PLANTAGO MAJOR; CALENDULA OFFICINALIS FLOWER; GRINDELIA HIRSUTULA FLOWERING TOP 4; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 51879-180_5e731fd1-7f61-c9af-e053-2a91aa0a55de 51879-180 HUMAN OTC DRUG Licefreee Head Lice Treatment SPRAY TOPICAL 20090501 UNAPPROVED HOMEOPATHIC Tec Laboratories, Inc. SODIUM CHLORIDE 2 [hp_X]/mL N 20181231 51879-191_5df9140f-ee33-ff80-e053-2991aa0a1d6c 51879-191 HUMAN OTC DRUG Licefreee Everyday Sodium Chloride SHAMPOO TOPICAL 20160713 UNAPPROVED HOMEOPATHIC Tec Laboratories,Inc. SODIUM CHLORIDE 2 [hp_X]/mL N 20181231 51879-210_44878ea4-d0e9-4509-8210-1a64f2cdb4d0 51879-210 HUMAN OTC DRUG Tecnu First Aid benzethonium chloride, lidocaine hydrochloride GEL TOPICAL 20120217 OTC MONOGRAPH NOT FINAL part348 Tec Laboratories, Inc. BENZETHONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 2; 25 mg/g; mg/g E 20171231 51879-240_5df8fa01-6d42-d809-e053-2991aa0aaba5 51879-240 HUMAN OTC DRUG Tecnu Bites and Stings Grindelia robusta,Plantago major,Calendula officinalis CLOTH TOPICAL 20160203 UNAPPROVED HOMEOPATHIC Tec Laboratories, Inc. GRINDELIA HIRSUTULA FLOWERING TOP; PLANTAGO MAJOR; CALENDULA OFFICINALIS FLOWER 3; 4; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 51879-800_5df9b9fc-d03e-7aac-e053-2a91aa0a0d74 51879-800 HUMAN OTC DRUG Tecnu Calagel Diphenydramine Hydrochloride, Zinc Acetate, Benzethonium Chloride GEL TOPICAL 19921009 OTC MONOGRAPH NOT FINAL part348 Tec Laboratories, Inc. BENZETHONIUM CHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.5; 20; 2.15 mg/g; mg/g; mg/g N 20181231 51885-3150_b8dd861c-013d-45bc-8db1-f10305a7acb5 51885-3150 HUMAN OTC DRUG Sinusin PULSATILLA VULGARIS and EUPHORBIA RESINIFERA RESIN and LUFFA OPSILVER NITRATEERCULATA FRUIT and MERCURIC IODIDE and SUS SCROFA NASAL MUCOSA and SILVER NITRATE and CALCIUM SULFIDE and SINUSITISINUM SOLUTION ORAL 20110101 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel PULSATILLA VULGARIS; EUPHORBIA RESINIFERA RESIN; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; SUS SCROFA NASAL MUCOSA; SILVER NITRATE; CALCIUM SULFIDE; SINUSITISINUM 2; 4; 6; 8; 8; 10; 10; 13 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL E 20171231 51885-3353_fe3f3fc6-bf04-416d-b1a9-f2a39935608a 51885-3353 HUMAN OTC DRUG Zeel SILICON DIOXIDE and COMFREY ROOT and ARNICA MONTANA ROOT and TOXICODENDRON PUBESCENS LEAF and SULFUR and SANGUINARIA CANADENSIS ROOT and SOLANUM DULCAMARA STEM and COENZYME A and NADIDE and SODIUM DIETHYL OXALACETATE and .ALPHA.-LIPOIC ACID and SUS SCROFA CARTILAGE and SUS SCROFA EMBRYO and SUS SCROFA UMBILICAL CORD and SUS SCROFA PLACENTA and OINTMENT TOPICAL 20111020 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel SILICON DIOXIDE; COMFREY ROOT; ARNICA MONTANA ROOT; TOXICODENDRON PUBESCENS LEAF; SULFUR; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA STEM; COENZYME A; NADIDE; SODIUM DIETHYL OXALACETATE; .ALPHA.-LIPOIC ACID; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA UMBILICAL CORD; SUS SCROFA PLACENTA 6; 8; 2; 2; 6; 2; 2; 6; 6; 6; 6; 2; 2; 2; 2 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g E 20171231 51885-7125_115a8772-4be5-46fd-ac5d-09ccb483889f 51885-7125 HUMAN OTC DRUG Traumeel X CALENDULA OFFICINALIS FLOWERING TOP and HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK and ARNICA MONTANA ROOT and ACONITUM NAPELLUS and ATROPA BELLADONNA and BELLIS PERENNIS and MATRICARIA RECUTITA and ECHINACEA, UNSPECIFIED and ECHINACEA PURPUREA and ACHILLEA MILLEFOLIUM and CALCIUM SULFIDE and MERCURIUS SOLUBILIS and COMFREY ROOT and HYPERICUM PERFORATUM and OINTMENT TOPICAL 20120524 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ARNICA MONTANA ROOT; ACONITUM NAPELLUS; ATROPA BELLADONNA; BELLIS PERENNIS; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; ACHILLEA MILLEFOLIUM; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; COMFREY ROOT; HYPERICUM PERFORATUM 1; 1; 3; 1; 1; 1; 1; 1; 1; 1; 6; 6; 4; 6 g/50g; g/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; g/50g; g/50g; g/50g; g/50g; g/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g N 20181231 51885-7500_b14584f8-bef2-4063-94da-52f17c109220 51885-7500 HUMAN OTC DRUG Vinceel APIS MELLIFERA and CYNANCHUM VINCETOXICUM LEAF and ATROPA BELLADONNA and CALENDULA OFFICINALIS FLOWERING TOP and ECHINACEA PURPUREA and PHYTOLACCA AMERICANA ROOT and PLANTAGO MAJOR and SAGE SPRAY ORAL 20060831 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel APIS MELLIFERA; CYNANCHUM VINCETOXICUM LEAF; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; SAGE 7; 5; 5; 3; 5; 3; 3; 3 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL E 20171231 51885-9482_fb1ef01d-90bb-4727-882a-d12146b5c7b4 51885-9482 HUMAN PRESCRIPTION DRUG Traumeel Rx ACONITUM NAPELLUS, ARNICA MONTANA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, ECHINACEA PURPUREA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALCIUM SULFIDE, HYPERICUM PERFORATUM, MERCURIUS SOLUBILIS, ACHILLEA MILLEFOLIUM and COMFREY ROOT OINTMENT TOPICAL 20160428 UNAPPROVED HOMEOPATHIC Biologische Heilmittel Heel ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; HYPERICUM PERFORATUM; MERCURIUS SOLUBILIS; ACHILLEA MILLEFOLIUM; COMFREY ROOT 1; 3; 1; 1; 1; 1; 1; 1; 1; 6; 6; 6; 1; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g E 20171231 51887-001_ad9691d2-ee2d-43a6-a847-57ec01f157c3 51887-001 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19930101 NDA NDA205766 Maine Oxy-Acetylene Supply Company NITROGEN 99 L/100L N 20181231 51887-200_35178b7f-8f51-4418-a2a5-eb74fda37c4d 51887-200 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Carbon Dioxide Oxygen GAS RESPIRATORY (INHALATION) 20040202 NDA NDA205764 Maine Oxy-Acetylene Supply Company CARBON DIOXIDE 200 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 51887-302_7eb6302e-aa1d-4ef1-a12e-6c5d24ba04cd 51887-302 HUMAN PRESCRIPTION DRUG Carbon Dioxide Nitrogen Carbon Dioxide Nitrogen GAS RESPIRATORY (INHALATION) 20040202 NDA NDA205764 Maine Oxy-Acetylene Supply Company CARBON DIOXIDE 200 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 51887-402_85ee706e-43b9-418a-a217-95fad975fb9c 51887-402 HUMAN PRESCRIPTION DRUG Carbon Dioxide Air Carbon Dioxide Air GAS RESPIRATORY (INHALATION) 20040202 NDA NDA205764 Maine Oxy-Acetylene Supply Company CARBON DIOXIDE 200 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 51887-502_4fee3b40-358c-41c6-818d-68c7dd4d2ff3 51887-502 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20040202 NDA NDA205767 Maine Oxy-Acetylene Supply Company OXYGEN 200 mL/L N 20181231 51887-720_4c78530f-648a-4f90-9a42-15173ec45b2e 51887-720 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19890101 NDA NDA205767 Maine Oxy-Acetylene Supply Company OXYGEN 990 mL/L N 20181231 51918-0001_5a39c3ab-d86f-1f18-e053-2991aa0ae6a7 51918-0001 HUMAN OTC DRUG DONGINBI Red Ginseng Moisturizing Sun Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane CREAM TOPICAL 20170928 OTC MONOGRAPH FINAL part352 Korea Ginseng Corp OCTISALATE; OCTINOXATE; AVOBENZONE 4.5; 7; 3 g/100mL; g/100mL; g/100mL N 20181231 51918-0002_5a39c3ab-d88b-1f18-e053-2991aa0ae6a7 51918-0002 HUMAN OTC DRUG DONGINBI Red Ginseng Perfect Sun Ethylhexyl methoxycinnamate, Ethylhexyl Salicylate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170928 OTC MONOGRAPH FINAL part352 Korea Ginseng Corp OCTISALATE; OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 5; 7.5; 4.9; 2.905 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 51918-0003_5a3a9c73-1d52-8673-e053-2a91aa0a22dc 51918-0003 HUMAN OTC DRUG RED GINSENG RADIANCE CUSHION BB No.21 Ethylhexyl Methoxycinnamate, Titanium Dioxide, Ethylhexyl Salicylate LIQUID TOPICAL 20170928 OTC MONOGRAPH FINAL part352 Korea Ginseng Corp OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE 5; 7; 12.5636 g/100g; g/100g; g/100g N 20181231 51918-0004_5a3a9c73-1d6f-8673-e053-2a91aa0a22dc 51918-0004 HUMAN OTC DRUG RED GINSENG RADIANCE CUSHION BB No.23 Ethylhexyl methoxycinnamate, Titanium Dioxide, Ethylhexyl Salicylate LIQUID TOPICAL 20170928 OTC MONOGRAPH FINAL part352 Korea Ginseng Corp OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE 5; 7; 12.5636 g/100g; g/100g; g/100g N 20181231 51918-1001_44f13ab9-0616-41f9-bd19-d0f75e8d558c 51918-1001 HUMAN OTC DRUG Cheong-Kwan-Jang Korean HongSam ASIAN GINSENG CAPSULE ORAL 20101115 UNAPPROVED DRUG OTHER Korea Ginseng Corporation ASIAN GINSENG 500 mg/500mg N 20181231 51918-1002_20c1042b-7a63-4ec5-8055-97c4a5723a4a 51918-1002 HUMAN OTC DRUG Cheong-Kwan-Jang Korean HongSam ASIAN GINSENG TABLET ORAL 20110224 UNAPPROVED DRUG OTHER Korea Ginseng Corporation ASIAN GINSENG 500 mg/90000mg N 20181231 51918-1003_bf605d58-852f-45ec-81ac-aadd3db006ed 51918-1003 HUMAN OTC DRUG Cheong-Kwan-Jang Korean HongSam ASIAN GINSENG POWDER ORAL 20101008 UNAPPROVED DRUG OTHER Korea Ginseng Corporation ASIAN GINSENG 90 g/90g N 20181231 51918-1005_01721e43-6c3e-455a-aeee-05d3e84183a5 51918-1005 HUMAN OTC DRUG Cheong-Kwan-Jang Sliced Korean HongSam ASIAN GINSENG BAR, CHEWABLE ORAL 20110531 UNAPPROVED DRUG OTHER Korea Ginseng Corporation ASIAN GINSENG 75 g/75g N 20181231 51960-001_5460a4b7-0f40-4229-ac45-9a3363452997 51960-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19980101 UNAPPROVED MEDICAL GAS Kent Welding Supply OXYGEN 99 L/100L E 20171231 51978-1001_7d5b3c37-847d-4db5-860c-180f6892ddee 51978-1001 HUMAN OTC DRUG Artemisia No Smoking WORMWOOD INHALANT ORAL 20140110 UNAPPROVED DRUG OTHER Donghwa Pharm Co., Ltd WORMWOOD 1 g/g E 20171231 51979-001_8215c6ed-5704-44de-8c75-9077610021b3 51979-001 HUMAN OTC DRUG Ouch Aid Arnica Compress Arnica Montana TINCTURE TOPICAL 20100910 UNAPPROVED HOMEOPATHIC Dr. Hauschka SkinCare Inc. ARNICA MONTANA 4 g/1 E 20171231 51985-010_e300aeff-a738-4157-a286-82ed693b1e50 51985-010 HUMAN OTC DRUG IONTOPHORESIS ANTI AGING SOLUTION I ALLANTOIN LOTION CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 ROCKET ELECTRIC CO., LTD. ALLANTOIN .1 mL/20mL E 20171231 51987-0002_5df8b718-71e1-4014-8641-98caf3346822 51987-0002 HUMAN OTC DRUG Hydrate II Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC Maplewood Company COFFEA ARABICA SEED, ROASTED; AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; HYPERICUM PERFORATUM; GINKGO; GERMANIUM SESQUIOXIDE; SILICON DIOXIDE 2; 3; 3; 3; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 51990-111_a602c1a5-0c9c-4489-bc71-5fd6e0b06cae 51990-111 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide galantamine hydrobromide TABLET, FILM COATED ORAL 20010301 NDA NDA021169 Yabao Pharmaceutical Co., Ltd. Beijing GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 51990-112_a602c1a5-0c9c-4489-bc71-5fd6e0b06cae 51990-112 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide galantamine hydrobromide TABLET, FILM COATED ORAL 20010301 NDA NDA021169 Yabao Pharmaceutical Co., Ltd. Beijing GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 51990-113_a602c1a5-0c9c-4489-bc71-5fd6e0b06cae 51990-113 HUMAN PRESCRIPTION DRUG Galantamine Hydrobromide galantamine hydrobromide TABLET, FILM COATED ORAL 20010301 NDA NDA021169 Yabao Pharmaceutical Co., Ltd. Beijing GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 51991-064_528eda32-9c82-42e0-883b-13ef563c7d91 51991-064 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION INTRAVENOUS 20170915 ANDA ANDA202163 Breckenridge Pharmaceutical, Inc ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 51991-065_6465cdc0-57c9-4f37-838f-6d6c7d1368d8 51991-065 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170915 ANDA ANDA091170 Breckenridge Pharmaceutical, Inc ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 51991-073_2d433ed3-4376-4849-8943-d832cfd73462 51991-073 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Butalbital, Acetaminophen, Caffeine and Codeine Phosphate CAPSULE ORAL 20040701 ANDA ANDA076560 Breckenridge Pharmaceutical, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 51991-074_3ab46727-2997-4e4e-8b0b-b69b00db9ca5 51991-074 HUMAN PRESCRIPTION DRUG Ascomp with Codeine Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE ORAL 20090501 ANDA ANDA075231 Breckenridge Pharmaceutical, Inc. BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 51991-144_9bd841af-cb33-406d-80b2-06391615fa4b 51991-144 HUMAN PRESCRIPTION DRUG METHYLERGONOVINE MALEATE Methylergonovine Maleate INJECTION INTRAVENOUS 20161107 ANDA ANDA040889 Breckenridge Pharmaceutical, Inc. METHYLERGONOVINE MALEATE .2 mg/mL Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 51991-191_6d3fa9e9-eb31-40f8-b4fa-e1c7c3f89006 51991-191 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide methscopolamine bromide TABLET ORAL 20120521 ANDA ANDA040642 Breckenridge Pharmaceutical, Inc. METHSCOPOLAMINE BROMIDE 2.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 51991-192_6d3fa9e9-eb31-40f8-b4fa-e1c7c3f89006 51991-192 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide methscopolamine bromide TABLET ORAL 20120521 ANDA ANDA040642 Breckenridge Pharmaceutical, Inc. METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 51991-218_f8a6be44-f539-45e1-9073-ce7ded3d3d2e 51991-218 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170901 ANDA ANDA204616 Breckenridge Pharmaceutical, Inc. OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 51991-219_f8a6be44-f539-45e1-9073-ce7ded3d3d2e 51991-219 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170901 ANDA ANDA204616 Breckenridge Pharmaceutical, Inc. OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 51991-292_cb6a679d-d9d7-42b0-bd83-ba9c485d0260 51991-292 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 Breckenridge Pharmaceutical, Inc. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51991-293_cb6a679d-d9d7-42b0-bd83-ba9c485d0260 51991-293 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 Breckenridge Pharmaceutical, Inc. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51991-294_cb6a679d-d9d7-42b0-bd83-ba9c485d0260 51991-294 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 Breckenridge Pharmaceutical, Inc. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51991-311_09d21d94-c779-4177-bf8e-a06433a5432f 51991-311 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine Succinate TABLET, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204003 Breckenridge Pharmaceutical, Inc DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 51991-312_09d21d94-c779-4177-bf8e-a06433a5432f 51991-312 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine Succinate TABLET, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204003 Breckenridge Pharmaceutical, Inc DESVENLAFAXINE SUCCINATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 51991-313_9358ab53-226f-4afa-b2b9-df5fde59b116 51991-313 HUMAN PRESCRIPTION DRUG Megestrol acetate MEGESTROL ACETATE SUSPENSION ORAL 20171201 ANDA ANDA204688 Breckenridge Pharmaceutical, Inc. MEGESTROL ACETATE 125 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 51991-322_0d1a6384-50ec-4488-9a91-470c4e75f32a 51991-322 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161128 ANDA ANDA202768 Breckenridge Pharmaceutical, Inc. ARMODAFINIL 50 mg/1 CIV N 20181231 51991-323_0d1a6384-50ec-4488-9a91-470c4e75f32a 51991-323 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161128 ANDA ANDA202768 Breckenridge Pharmaceutical, Inc. ARMODAFINIL 150 mg/1 CIV N 20181231 51991-324_0d1a6384-50ec-4488-9a91-470c4e75f32a 51991-324 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161128 ANDA ANDA202768 Breckenridge Pharmaceutical, Inc. ARMODAFINIL 250 mg/1 CIV N 20181231 51991-331_996b0adc-01de-4c25-995e-ba95ce8059d4 51991-331 HUMAN PRESCRIPTION DRUG Nevirapine NEVIRAPINE TABLET ORAL 20110411 ANDA ANDA078644 Breckenridge Pharmaceutical, Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 51991-333_64a78ea1-9918-427b-a7ac-0a19ccab8300 51991-333 HUMAN PRESCRIPTION DRUG Carbinoxamine Maleate carbinoxamine maleate TABLET ORAL 20121210 ANDA ANDA040442 Breckenridge Pharmaceutical, Inc. CARBINOXAMINE MALEATE 4 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 51991-334_64a78ea1-9918-427b-a7ac-0a19ccab8300 51991-334 HUMAN PRESCRIPTION DRUG Carbinoxamine Maleate carbinoxamine maleate SYRUP ORAL 20121210 ANDA ANDA040458 Breckenridge Pharmaceutical, Inc. CARBINOXAMINE MALEATE 4 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 51991-348_b4c6bc3b-3d9a-4518-94f1-d620bf5c3e8c 51991-348 HUMAN PRESCRIPTION DRUG LACOSAMIDE LACOSAMIDE TABLET, FILM COATED ORAL 20160615 ANDA ANDA204921 Breckenridge Pharmaceutical, Inc. LACOSAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 51991-349_b4c6bc3b-3d9a-4518-94f1-d620bf5c3e8c 51991-349 HUMAN PRESCRIPTION DRUG LACOSAMIDE LACOSAMIDE TABLET, FILM COATED ORAL 20160615 ANDA ANDA204921 Breckenridge Pharmaceutical, Inc. LACOSAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 51991-350_b4c6bc3b-3d9a-4518-94f1-d620bf5c3e8c 51991-350 HUMAN PRESCRIPTION DRUG LACOSAMIDE LACOSAMIDE TABLET, FILM COATED ORAL 20160615 ANDA ANDA204921 Breckenridge Pharmaceutical, Inc. LACOSAMIDE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 51991-351_b4c6bc3b-3d9a-4518-94f1-d620bf5c3e8c 51991-351 HUMAN PRESCRIPTION DRUG LACOSAMIDE LACOSAMIDE TABLET, FILM COATED ORAL 20160615 ANDA ANDA204921 Breckenridge Pharmaceutical, Inc. LACOSAMIDE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 51991-354_f8df58ce-9724-48bf-84c1-cda9d62c7291 51991-354 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA200482 Breckenridge Pharmaceutical, Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 51991-355_f8df58ce-9724-48bf-84c1-cda9d62c7291 51991-355 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA200482 Breckenridge Pharmaceutical, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 51991-362_d1569e0b-8a1a-4b86-acb6-69b4c7ec7ef4 51991-362 HUMAN PRESCRIPTION DRUG RIZATRIPTAN Benzoate RIZATRIPTAN Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203478 Breckenridge Pharmaceutical, Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 51991-363_d1569e0b-8a1a-4b86-acb6-69b4c7ec7ef4 51991-363 HUMAN PRESCRIPTION DRUG RIZATRIPTAN Benzoate RIZATRIPTAN Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203478 Breckenridge Pharmaceutical, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 51991-457_22194a8c-348c-4781-bb56-ff7aa1c6ea0e 51991-457 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20060906 ANDA ANDA077706 Breckenridge Pharmaceutical, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 51991-474_2caec137-d8d4-4a0a-a193-b3877c39bb34 51991-474 HUMAN PRESCRIPTION DRUG Estradiol / Norethindrone Acetate Estradiol and Norethindrone Acetate TABLET, FILM COATED ORAL 20080417 ANDA ANDA078324 Breckenridge Pharmaceutical, Inc. ESTRADIOL; NORETHINDRONE ACETATE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 51991-526_fb40bdbe-c568-40ce-aabc-378465450a94 51991-526 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20101227 ANDA ANDA077714 Breckenridge Pharmaceutical, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 51991-604_1ca6f78c-f5fc-4fa1-8886-e5a8ed9686e7 51991-604 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 Breckenridge Pharmaceutical, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 51991-611_08f446b8-af4f-49be-9cf9-f7a2c4802bae 51991-611 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride SOLUTION ORAL 20171101 ANDA ANDA201466 Breckenridge Pharmaceutical, Inc. METHYLPHENIDATE HYDROCHLORIDE 1 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 51991-612_08f446b8-af4f-49be-9cf9-f7a2c4802bae 51991-612 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride SOLUTION ORAL 20171101 ANDA ANDA201466 Breckenridge Pharmaceutical, Inc. METHYLPHENIDATE HYDROCHLORIDE 2 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 51991-620_95eb0931-d177-40f6-9bf4-6ba20c9cbf43 51991-620 HUMAN PRESCRIPTION DRUG ANASTROZOLE ANASTROZOLE TABLET ORAL 20100628 ANDA ANDA079220 Breckenridge Pharmaceutical, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 51991-623_2caec137-d8d4-4a0a-a193-b3877c39bb34 51991-623 HUMAN PRESCRIPTION DRUG Estradiol / Norethindrone Acetate Estradiol and Norethindrone Acetate TABLET, FILM COATED ORAL 20110609 ANDA ANDA078324 Breckenridge Pharmaceutical, Inc. ESTRADIOL; NORETHINDRONE ACETATE .5; .1 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 51991-642_220e9e34-e27e-4367-8d91-47054eda3463 51991-642 HUMAN PRESCRIPTION DRUG OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS ORAL 20170703 ANDA ANDA203481 Breckenridge Pharmaceutical, Inc. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 51991-643_220e9e34-e27e-4367-8d91-47054eda3463 51991-643 HUMAN PRESCRIPTION DRUG OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS ORAL 20170703 ANDA ANDA203481 Breckenridge Pharmaceutical, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 51991-644_220e9e34-e27e-4367-8d91-47054eda3463 51991-644 HUMAN PRESCRIPTION DRUG OMEPRAZOLE OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS ORAL 20170703 ANDA ANDA203481 Breckenridge Pharmaceutical, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 51991-651_e727ff4c-0120-45fa-92f3-c7c0055f37f8 51991-651 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM SOLUTION ORAL 20131119 ANDA ANDA079120 Breckenridge Pharmaceutical, Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51991-683_999613a1-4b6d-4eb8-9126-f23e966b3a8f 51991-683 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20170601 ANDA ANDA204237 Breckenridge Pharmaceutical, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 51991-712_28e72f97-e556-4bdc-b6b8-1300c88bc6ef 51991-712 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20100701 ANDA ANDA091601 Breckenridge Pharmaceutical, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 51991-713_28e72f97-e556-4bdc-b6b8-1300c88bc6ef 51991-713 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20100701 ANDA ANDA091601 Breckenridge Pharmaceutical, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 51991-714_a4f5043d-7639-4cec-b9fb-7173e701e91e 51991-714 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN SOLUTION ORAL 20170501 ANDA ANDA091286 Breckenridge Pharmaceutical, Inc. GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 51991-716_23e69e6c-c45e-4ecb-9c13-33d978030534 51991-716 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20140129 ANDA ANDA079059 Breckenridge Pharmaceutical, Inc. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 51991-735_52ecfab2-4bc1-490b-86f3-ed01ce39f274 51991-735 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET ORAL 20090622 ANDA ANDA078969 Breckenridge Pharmaceutical, Inc. GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 51991-738_42f45470-9fa0-4d1d-8d99-4e1a8bdc1488 51991-738 HUMAN PRESCRIPTION DRUG NEOMYCIN SULFATE NEOMYCIN SULFATE TABLET ORAL 20110103 ANDA ANDA065468 Breckenridge Pharmaceutical, Inc. NEOMYCIN SULFATE 350 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 51991-746_1b9e3dd2-eedd-47f4-a381-055e7262be63 51991-746 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Breckenridge Pharmaceutical, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51991-747_1b9e3dd2-eedd-47f4-a381-055e7262be63 51991-747 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Breckenridge Pharmaceutical, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51991-748_1b9e3dd2-eedd-47f4-a381-055e7262be63 51991-748 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Breckenridge Pharmaceutical, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 51991-749_3c751a2d-04d6-4362-8f0d-c64428793e99 51991-749 HUMAN PRESCRIPTION DRUG DUTASTERIDE DUTASTERIDE CAPSULE ORAL 20151120 ANDA ANDA204705 Breckenridge Pharmaceutical, Inc. DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 51991-759_8922b43a-0447-4d71-bbcb-e47ea0320de7 51991-759 HUMAN PRESCRIPTION DRUG LETROZOLE LETROZOLE TABLET ORAL 20110604 ANDA ANDA200161 Breckenridge Pharmaceutical, Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 51991-771_715966c0-40f5-42a6-a4c2-1f7fe6ee8677 51991-771 HUMAN PRESCRIPTION DRUG LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED RELEASE ORAL 20121218 ANDA ANDA201921 Breckenridge Pharmaceutical, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 51991-772_715966c0-40f5-42a6-a4c2-1f7fe6ee8677 51991-772 HUMAN PRESCRIPTION DRUG LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED RELEASE ORAL 20121218 ANDA ANDA201921 Breckenridge Pharmaceutical, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 51991-793_a41cadb5-ffcf-42ce-9e20-a5d99eaf30e4 51991-793 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120613 ANDA ANDA091689 Breckenridge Pharmaceutical, Inc RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 51991-794_a41cadb5-ffcf-42ce-9e20-a5d99eaf30e4 51991-794 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120613 ANDA ANDA091689 Breckenridge Pharmaceutical, Inc RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 51991-795_a41cadb5-ffcf-42ce-9e20-a5d99eaf30e4 51991-795 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120613 ANDA ANDA091689 Breckenridge Pharmaceutical, Inc RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 51991-796_a41cadb5-ffcf-42ce-9e20-a5d99eaf30e4 51991-796 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120613 ANDA ANDA091689 Breckenridge Pharmaceutical, Inc RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 51991-797_c70de10e-55ff-423d-b3bd-99e36943cfee 51991-797 HUMAN PRESCRIPTION DRUG Azacitidine Azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20170623 ANDA ANDA207234 Breckenridge Pharmaceutical, Inc. AZACITIDINE 100 mg/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 51991-805_a82bcd8e-4d3e-4c6e-aa80-d8451494c028 51991-805 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20180119 ANDA ANDA076033 Breckenridge Pharmaceutical, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51991-806_a82bcd8e-4d3e-4c6e-aa80-d8451494c028 51991-806 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20180119 ANDA ANDA076033 Breckenridge Pharmaceutical, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51991-807_a82bcd8e-4d3e-4c6e-aa80-d8451494c028 51991-807 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET ORAL 20180119 ANDA ANDA076033 Breckenridge Pharmaceutical, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 51991-814_653bd29c-4285-495e-870a-5f7072d7f440 51991-814 HUMAN PRESCRIPTION DRUG AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE SPRAY, METERED NASAL 20150729 ANDA ANDA090176 Breckenridge Pharmaceutical, Inc. AZELASTINE HYDROCHLORIDE 137 ug/.137mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 51991-817_c5a3f30f-8f4a-477a-858f-60c744a2cb00 51991-817 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130311 ANDA ANDA078703 Breckenridge Pharmaceutical, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51991-818_c5a3f30f-8f4a-477a-858f-60c744a2cb00 51991-818 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130311 ANDA ANDA078703 Breckenridge Pharmaceutical, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51991-819_c5a3f30f-8f4a-477a-858f-60c744a2cb00 51991-819 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130311 ANDA ANDA078703 Breckenridge Pharmaceutical, Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51991-820_c5a3f30f-8f4a-477a-858f-60c744a2cb00 51991-820 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130311 ANDA ANDA078703 Breckenridge Pharmaceutical, Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51991-836_2494d258-c8f0-4a62-bea4-6c2b9a2a5adc 51991-836 HUMAN PRESCRIPTION DRUG Epinastine Hydrochloride Epinastine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20131105 ANDA ANDA090870 Breckenridge Pharmaceutical, Inc. EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 51991-837_ccf6faa6-4bed-4a74-a34a-927309dcb3b5 51991-837 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20131203 ANDA ANDA078488 Breckenridge Pharmaceutical, Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 51991-838_09ea763c-dc87-42ea-8a02-e488fc074d2a 51991-838 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20131021 ANDA ANDA040644 Breckenridge Pharmaceutical, Inc. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 51991-839_34079284-c0ab-4c5c-8c73-ee8ad9a7af44 51991-839 HUMAN PRESCRIPTION DRUG Mefenamic Acid Mefenamic Acid CAPSULE ORAL 20141013 ANDA ANDA090359 Breckenridge Pharmaceutical, Inc. MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 51991-853_551a2e3b-07a6-4b7a-86ef-215477f09fa9 51991-853 HUMAN PRESCRIPTION DRUG REPAGLINIDE REPAGLINIDE TABLET ORAL 20150501 ANDA ANDA091517 Breckenridge Pharmaceutical, Inc. REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 51991-854_551a2e3b-07a6-4b7a-86ef-215477f09fa9 51991-854 HUMAN PRESCRIPTION DRUG REPAGLINIDE REPAGLINIDE TABLET ORAL 20150501 ANDA ANDA091517 Breckenridge Pharmaceutical, Inc. REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 51991-855_551a2e3b-07a6-4b7a-86ef-215477f09fa9 51991-855 HUMAN PRESCRIPTION DRUG REPAGLINIDE REPAGLINIDE TABLET ORAL 20150501 ANDA ANDA091517 Breckenridge Pharmaceutical, Inc. REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 51991-922_91ff7efe-d230-4201-8f93-b1a2faaaa72d 51991-922 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20170220 ANDA ANDA207325 Breckenridge Pharmaceutical, Inc. OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 51991-923_91ff7efe-d230-4201-8f93-b1a2faaaa72d 51991-923 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20170220 ANDA ANDA207325 Breckenridge Pharmaceutical, Inc. OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 51991-933_f898eb58-8608-4c9e-aad3-78c1da2c7b41 51991-933 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol Lactate INJECTION INTRAMUSCULAR 20160104 ANDA ANDA076774 Breckenridge Pharmaceutical, Inc. HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20181231 51991-934_f0cf54ee-4d83-4a68-970f-a7eda7a010e2 51991-934 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20170315 ANDA ANDA090699 Breckenridge Pharmaceutical, Inc. LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51991-935_f0cf54ee-4d83-4a68-970f-a7eda7a010e2 51991-935 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20170315 ANDA ANDA090699 Breckenridge Pharmaceutical, Inc. LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 51991-936_4dfccf13-57e6-476d-99e0-6edba74b8268 51991-936 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20160930 ANDA ANDA207326 Breckenridge Pharmaceutical, Inc. PACLITAXEL 30 mg/5mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 51991-937_4dfccf13-57e6-476d-99e0-6edba74b8268 51991-937 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20160930 ANDA ANDA207326 Breckenridge Pharmaceutical, Inc. PACLITAXEL 100 mg/16.7mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 51991-938_4dfccf13-57e6-476d-99e0-6edba74b8268 51991-938 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20160930 ANDA ANDA207326 Breckenridge Pharmaceutical, Inc. PACLITAXEL 300 mg/50mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 51991-939_39254da0-1343-40b1-bba0-7062e9884089 51991-939 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B INJECTION, SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20160601 ANDA ANDA207322 Breckenridge Pharmaceutical, Inc. POLYMYXIN B SULFATE 500000 1/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 51991-940_5332fc57-b49c-4d57-bd7f-de4e4c25c1b8 51991-940 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin INJECTION, SOLUTION INTRAVENOUS 20160223 ANDA ANDA205694 Breckenridge Pharmaceutical, Inc. VANCOMYCIN HYDROCHLORIDE 500 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 51991-941_5332fc57-b49c-4d57-bd7f-de4e4c25c1b8 51991-941 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin INJECTION, SOLUTION INTRAVENOUS 20160223 ANDA ANDA205694 Breckenridge Pharmaceutical, Inc. VANCOMYCIN HYDROCHLORIDE 1 g/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 51991-942_46cc35ce-76d6-473e-a0bf-24d973c20791 51991-942 HUMAN PRESCRIPTION DRUG Dexrazoxane Dexrazoxane Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20161205 ANDA ANDA207321 Breckenridge Pharmaceutical, Inc. DEXRAZOXANE HYDROCHLORIDE 500 mg/50mL Cytoprotective Agent [EPC] N 20181231 51991-943_4e7c3467-c221-6034-e054-00144ff88e88 51991-943 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET ORAL 20170502 ANDA ANDA205348 Breckenridge Pharmaceutical, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 51991-944_4f31df66-7d7c-1f04-e054-00144ff88e88 51991-944 HUMAN PRESCRIPTION DRUG Trimipramine Maleate Trimipramine Maleate CAPSULE ORAL 20170405 ANDA ANDA208127 Breckenridge Pharmaceutical, Inc. TRIMIPRAMINE MALEATE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51991-945_4f31df66-7d7c-1f04-e054-00144ff88e88 51991-945 HUMAN PRESCRIPTION DRUG Trimipramine Maleate Trimipramine Maleate CAPSULE ORAL 20170405 ANDA ANDA208127 Breckenridge Pharmaceutical, Inc. TRIMIPRAMINE MALEATE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51991-946_4f31df66-7d7c-1f04-e054-00144ff88e88 51991-946 HUMAN PRESCRIPTION DRUG Trimipramine Maleate Trimipramine Maleate CAPSULE ORAL 20170405 ANDA ANDA208127 Breckenridge Pharmaceutical, Inc. TRIMIPRAMINE MALEATE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 51996-001_0d2ffce7-837b-439f-920f-e770a2a797ce 51996-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19760101 NDA NDA205840 Mississippi Welders Supply Company, Inc. OXYGEN 990 mL/L N 20181231 51996-003_b584d419-50ee-4735-9be2-f8751f324714 51996-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20100301 NDA NDA205839 Mississippi Welders Supply Company, Inc. NITROGEN 990 mL/L N 20181231 51997-035_4298c46d-2fc3-44f2-b096-fbce32d993fa 51997-035 HUMAN OTC DRUG Emergency Eye Wash, PW, Sterile Ster-Aide Water FOR SOLUTION OPHTHALMIC 20120910 OTC MONOGRAPH NOT FINAL part349 Asept Pak, Inc. WATER 14.85 mL/15mL E 20171231 52000-000_dfb66c9b-7a5e-460d-9246-add7557a3f60 52000-000 HUMAN OTC DRUG Allure Creamy Petroleum PETROLATUM JELLY TOPICAL 20121219 OTC MONOGRAPH FINAL part347 Universal Distribution Center LLC PETROLATUM 30 g/100g E 20171231 52000-001_d38ed427-5265-4081-9a9b-8c26ace4726b 52000-001 HUMAN OTC DRUG Allure Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120629 OTC MONOGRAPH FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 52000-002_3ad3b5b6-0bb2-43fe-920f-eef7f6beeba9 52000-002 HUMAN OTC DRUG Allure Isopropyl Rubbing Alcohol With Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20120630 OTC MONOGRAPH FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 52000-003_47d12679-b500-4813-b53d-c9d4e1d1bcde 52000-003 HUMAN OTC DRUG Allure Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20120630 OTC MONOGRAPH FINAL part341 Universal Distribution Center LLC CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.7; 1; 1 g/100g; g/100g; g/100g N 20181231 52000-004_da83c7c6-bf57-4c6e-bb44-d76c14c8cacc 52000-004 HUMAN OTC DRUG Allure Ice Cold Analgesic Menthol and Camphor GEL TOPICAL 20120630 OTC MONOGRAPH FINAL part341 Universal Distribution Center LLC MENTHOL; CAMPHOR (SYNTHETIC) 1; .5 g/100g; g/100g N 20181231 52000-005_5c0333ab-173d-465f-abf3-22f93cba6d32 52000-005 HUMAN OTC DRUG UNIVERSAL PURE PETROLEUM White Petroleum JELLY TOPICAL 20130206 OTC MONOGRAPH FINAL part347 Universal Distribution Center LLC PETROLATUM 1 g/g N 20181231 52000-006_c3b383bd-a87f-48e2-b66a-33f37a741924 52000-006 HUMAN OTC DRUG UNIVERSAL BABY FRESH SCENT PETROLEUM White Petroleum JELLY TOPICAL 20130206 OTC MONOGRAPH FINAL part347 Universal Distribution Center LLC PETROLATUM .99 g/g N 20181231 52000-007_489d6588-db36-4ad6-bb27-effe41162a89 52000-007 HUMAN OTC DRUG UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED White Petroleum JELLY TOPICAL 20130206 OTC MONOGRAPH FINAL part347 Universal Distribution Center LLC PETROLATUM 1 g/g N 20181231 52000-008_92adc7a8-fb36-4bca-806d-c1bb753e359d 52000-008 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50% Isopropyl Alcohol LIQUID TOPICAL 20120313 OTC MONOGRAPH NOT FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 52000-009_4c4f771a-77e2-4024-bccc-1c79a90e5a6f 52000-009 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50% With Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 52000-010_43ddb2eb-eba8-4838-b933-aa0ce14b2b16 52000-010 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70% Isopropyl Alcohol LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 52000-011_0913f786-de59-4d76-a36c-26de14a1de5c 52000-011 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70% With Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 52000-012_0b218f94-6be0-2ca5-e054-00144ff88e88 52000-012 HUMAN OTC DRUG Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part341 Universal Distribution Center LLC CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.7; 1; 1 g/100g; g/100g; g/100g N 20181231 52000-013_149e60fd-1d2b-498e-9164-b37d82d91e5b 52000-013 HUMAN OTC DRUG Ice Cold Analgesic Gel Menthol and Camphor GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part341 Universal Distribution Center LLC MENTHOL; CAMPHOR (SYNTHETIC) 1; .5 g/100g; g/100g N 20181231 52000-014_3c0cc40b-7e1b-46e6-ad44-33ff1f43d1bb 52000-014 HUMAN OTC DRUG Creamy Petroleum Jelly Petrolatum JELLY TOPICAL 20140819 OTC MONOGRAPH FINAL part347 Universal Distribution Center LLC PETROLATUM 30 g/100g N 20181231 52000-015_08c4c494-1bf1-32ac-e054-00144ff88e88 52000-015 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20141122 OTC MONOGRAPH NOT FINAL part333E Universal Distribution Center LLC ALCOHOL 70 mL/100mL E 20171231 52000-016_0929689b-d8e6-5f1e-e054-00144ff8d46c 52000-016 HUMAN OTC DRUG Instant Hand Sanitizer Aloe Vera Ethyl Alcohol LIQUID TOPICAL 20141122 OTC MONOGRAPH NOT FINAL part333E Universal Distribution Center LLC ALCOHOL 70 mL/100mL E 20171231 52000-017_0929689b-d8f4-5f1e-e054-00144ff8d46c 52000-017 HUMAN OTC DRUG Instant Hand Sanitizer Lavender Ethyl Alcohol LIQUID TOPICAL 20141122 OTC MONOGRAPH NOT FINAL part333E Universal Distribution Center LLC ALCOHOL 70 mL/100mL E 20171231 52000-018_0929689b-d905-5f1e-e054-00144ff8d46c 52000-018 HUMAN OTC DRUG Instant Hand Sanitizer Citrus Zest Ethyl Alcohol LIQUID TOPICAL 20141122 OTC MONOGRAPH NOT FINAL part333E Universal Distribution Center LLC ALCOHOL 70 mL/100mL E 20171231 52000-019_13db3467-7508-1563-e054-00144ff8d46c 52000-019 HUMAN OTC DRUG Triple Antibiotic First Aid Bacitracin Zinc, Neomycin and Polymyxin B Sulfate OINTMENT TOPICAL 20150415 OTC MONOGRAPH FINAL part333B Universal Distribution Center LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 52000-020_13db3467-7516-1563-e054-00144ff8d46c 52000-020 HUMAN OTC DRUG Muscle Rub Menthol GEL TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC MENTHOL .025 g/g N 20181231 52000-021_13db415f-a658-143b-e054-00144ff8d46c 52000-021 HUMAN OTC DRUG Anti-Fungal Miconazole Nitrate CREAM TOPICAL 20150415 OTC MONOGRAPH FINAL part333C Universal Distribution Center LLC MICONAZOLE NITRATE .02 g/g N 20181231 52000-022_13db415f-a669-143b-e054-00144ff8d46c 52000-022 HUMAN OTC DRUG Hydrocortisone Anti-Itch Hydrocortisone CREAM TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC HYDROCORTISONE .01 g/g N 20181231 52000-023_13db415f-a67c-143b-e054-00144ff8d46c 52000-023 HUMAN OTC DRUG Anti-Itch Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE .02; .001 g/g; g/g N 20181231 52000-024_23a576cc-286d-4cc1-e054-00144ff88e88 52000-024 HUMAN OTC DRUG Medicated Body Menthol and Zinc Oxide POWDER TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g N 20181231 52000-025_256257cf-a762-6b60-e054-00144ff88e88 52000-025 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20151125 OTC MONOGRAPH NOT FINAL part333A Universal Distribution Center LLC HYDROGEN PEROXIDE 3 mL/100mL N 20181231 52000-026_39419ec3-5756-05f7-e054-00144ff88e88 52000-026 HUMAN OTC DRUG Vitamin A and D Vitamin A and D CREAM TOPICAL 20160804 OTC MONOGRAPH NOT FINAL part347 Universal Distribution Center LLC VITAMIN A; VITAMIN D 181.8; 1200 [iU]/g; [iU]/g N 20181231 52000-027_3941bd63-6cc4-72c1-e054-00144ff88e88 52000-027 HUMAN OTC DRUG First Aid Lidocaine HCL and Phenol CREAM TOPICAL 20160804 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC LIDOCAINE HYDROCHLORIDE; PHENOL .005; .005 g/g; g/g N 20181231 52000-028_39559f5a-9975-0026-e054-00144ff8d46c 52000-028 HUMAN OTC DRUG Hemorrhoid Anesthetic Mineral Oil, Petrolatum, Phenylephrine HCL OINTMENT TOPICAL 20160805 OTC MONOGRAPH FINAL part346 Universal Distribution Center LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE .14; .749; .0025 g/g; g/g; g/g N 20181231 52000-029_57fcd577-9455-4cee-e053-2991aa0a266b 52000-029 HUMAN OTC DRUG MEDICATED NO MESS APPLICATOR menthol LIQUID TOPICAL 20170830 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC MENTHOL .16 g/mL N 20181231 52000-030_407ca437-f731-601d-e054-00144ff88e88 52000-030 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 99% Isopropyl Alcohol LIQUID TOPICAL 20161104 OTC MONOGRAPH NOT FINAL part333A Universal Distribution Center LLC ISOPROPYL ALCOHOL 99 mL/100mL N 20181231 52000-031_526ae80f-bb15-6aa8-e054-00144ff8d46c 52000-031 HUMAN OTC DRUG Capsaicin Heat capsaicin PATCH TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC CAPSAICIN .6 mg/1 N 20181231 52000-032_5269f1d1-937e-3ec2-e054-00144ff8d46c 52000-032 HUMAN OTC DRUG Cold and Hot Medicated Patch menthol PATCH TOPICAL 20170621 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC MENTHOL 205.5 mg/1 N 20181231 52000-033_5269f5fd-a33a-3653-e054-00144ff88e88 52000-033 HUMAN OTC DRUG Cold and Hot Medicated Large menthol PATCH TOPICAL 20170621 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC MENTHOL 428.5 mg/1 N 20181231 52000-034_526accc4-636b-5adf-e054-00144ff88e88 52000-034 HUMAN OTC DRUG Pain Relief Hot Patch menthol and capsaicin PATCH TOPICAL 20170621 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC MENTHOL; CAPSAICIN 30; 8.3 mg/1; mg/1 N 20181231 52000-035_527c64a8-4a3b-3ebd-e054-00144ff88e88 52000-035 HUMAN OTC DRUG ADVANCED WHITENING ANTI CAVITY FLUORIDE SODIUM FLUORIDE PASTE ORAL 20170621 OTC MONOGRAPH FINAL part355 Universal Distribution Center LLC SODIUM FLUORIDE 1.5 mg/g N 20181231 52000-036_527c9ca6-ad0c-172b-e054-00144ff8d46c 52000-036 HUMAN OTC DRUG ANTI CAVITY FLUORIDE Sodium Monofluorophosphate PASTE ORAL 20170621 OTC MONOGRAPH FINAL part355 Universal Distribution Center LLC SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 52000-037_527d601e-591a-38fb-e054-00144ff8d46c 52000-037 HUMAN OTC DRUG SENSITIVE ANTI-CAVITY potassium nitrate and sodium fluoride PASTE ORAL 20170621 OTC MONOGRAPH NOT FINAL part356 Universal Distribution Center LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 52000-038_5f86e792-3255-4ee6-e053-2991aa0a54a0 52000-038 HUMAN OTC DRUG Medicated Body Menthol and Zinc Oxide POWDER TOPICAL 20171204 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g N 20181231 52000-063_574dfd30-4caf-c05b-e053-2a91aa0a0d8b 52000-063 HUMAN OTC DRUG Ultra Strength Pain Relief Balm camphor, menthol OINTMENT TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC CAMPHOR (SYNTHETIC); MENTHOL .11; .11 g/g; g/g N 20181231 52000-135_58113333-a2d0-2cd0-e053-2991aa0a35ef 52000-135 HUMAN OTC DRUG ULTRA STRENGTH PAIN RELIEF capsaicin LIQUID TOPICAL 20170831 OTC MONOGRAPH NOT FINAL part348 Universal Distribution Center LLC CAPSAICIN .0015 g/mL N 20181231 52003-011_334eb212-37f1-4a84-8489-f11a05588d4a 52003-011 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205817 Linde Canada LTD OXYGEN 995 mL/L N 20181231 52003-016_0f09ab6c-d505-4c10-9672-eb689a38d14a 52003-016 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Linde Canada LTD NITROGEN 995 mL/L N 20181231 52007-101_4199a5a6-005e-4693-9a89-c986c0918135 52007-101 HUMAN OTC DRUG EZ-SAN Anti-Bacterial Foam Hand Triclosan SOAP TOPICAL 20160422 20180811 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. TRICLOSAN 3 mg/mL N 20181231 52007-110_fb7ddb5c-cb18-4c24-a89b-664aaf9d40d9 52007-110 HUMAN OTC DRUG Sanitex MVP Liquid Anti-Bacterial Chloroxylenol SOAP TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. CHLOROXYLENOL 10 mg/mL N 20181231 52007-140_3bc8783a-a243-48ed-ae33-16cada2f6084 52007-140 HUMAN OTC DRUG Sanitex MVP Instant-Hand Sanitizer Alcohol-Free Benzalkonium Chloride SOAP TOPICAL 20120924 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 52007-141_d26c4bcd-19b1-4654-a977-5a5cf2254e51 52007-141 HUMAN OTC DRUG EZ-SAN Instant-Hand Sanitizer Alcohol-Free Benzalkonium Chloride SOAP TOPICAL 20160422 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 52007-240_3e6a5319-2d19-4a2d-9f3c-eb0629ea02ee 52007-240 HUMAN OTC DRUG Altair Hand Care System Instant-Hand Sanitizer Alcohol-Free Benzalkonium Chloride SOAP TOPICAL 20140502 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 52007-340_b609407a-6818-41bd-a04f-1242f2fb7e12 52007-340 HUMAN OTC DRUG OK Instant-Hand Sanitizer Alcohol-Free Benzalkonium Chloride SOAP TOPICAL 20161028 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 52007-400_47d44b54-1b4f-405c-b9bf-050bf1e5468e 52007-400 HUMAN OTC DRUG Sanitex MVP Foam Anti-Bacterial Chloroxylenol SOAP TOPICAL 20161017 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. CHLOROXYLENOL 7.5 mg/mL N 20181231 52007-480_7e374fb1-ccd9-4877-a579-7e534d704bc0 52007-480 HUMAN OTC DRUG Sanitex MVP Instant Hand Sanitizer Alcohol SPRAY TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. ALCOHOL 650 mL/L N 20181231 52007-600_3e20c0f9-d0cb-4c4c-b11b-f7dffd999a19 52007-600 HUMAN OTC DRUG OK Foam Anti-Bacterial Chloroxylenol SOAP TOPICAL 20161028 OTC MONOGRAPH NOT FINAL part333E Vectair Systems, Inc. CHLOROXYLENOL 7.5 mg/mL N 20181231 52015-080_2dd1e338-2a3b-4f1c-9b5b-79262bbe93e6 52015-080 HUMAN PRESCRIPTION DRUG Dificid fidaxomicin TABLET, FILM COATED ORAL 20110527 NDA NDA201699 Merck Sharp & Dohme Corp. FIDAXOMICIN 200 mg/1 Macrolides [Chemical/Ingredient],Macrolide Antibacterial [EPC] N 20181231 52019-001_6e390a81-11d0-48d6-b8b1-591efe1aac8a 52019-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20101001 UNAPPROVED MEDICAL GAS All-Med, Inc OXYGEN 99 L/100L E 20171231 52030-773_700125b6-84e9-42b6-a43d-767be4d538db 52030-773 HUMAN OTC DRUG SaniFoam ALCOHOL AEROSOL, FOAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 Genesan Systems ALCOHOL 620 mg/g N 20181231 52030-783_a2c6f6b6-f7ed-47a2-9077-8e0bd8aefe81 52030-783 HUMAN OTC DRUG Hand Sanitizer Wipes ALCOHOL CLOTH TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part333 Genesan Systems ALCOHOL 620 mg/g N 20181231 52031-0875_dbf36949-ac4a-44e7-863b-e0bd23327bcf 52031-0875 HUMAN OTC DRUG Dettol First Aid Antiseptic Chloroxylenol SOLUTION TOPICAL 19890208 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser (UK) Ltd CHLOROXYLENOL 4.8 g/100mL N 20181231 52033-001_426594cd-3665-4f6e-870e-70219780f0d1 52033-001 HUMAN OTC DRUG ESCA Hand Sanitizing Wipes Alcohol LIQUID TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 ESCA Tech, Inc. ALCOHOL 65 mL/100mL E 20171231 52039-001_c62bdafb-778a-4455-a077-2794f2c11099 52039-001 HUMAN OTC DRUG NATURES PURITY Scented White Petrolatum OINTMENT TOPICAL 20120718 OTC MONOGRAPH FINAL part347 AMERICAN EAGLE STAR IMPORTS INC. PETROLATUM 99.9 g/100g E 20171231 52053-0001_1cb25f33-00b6-4203-928f-f6e88251b30c 52053-0001 HUMAN OTC DRUG Sambucol Cold and Flu Relief Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum TABLET, ORALLY DISINTEGRATING ORAL 20130326 UNAPPROVED HOMEOPATHIC PharmaCare US, Inc. BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; ZINC GLUCONATE 6; 6; 3; 12; 2 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 52053-0002_0c819edf-9990-4136-a269-1e7607f8e841 52053-0002 HUMAN OTC DRUG Sambucol Cold and Flu Night Time Syrup Byronia, Chamomilla, Gelsemium Sempervirens, Passiflora Incarnata, Sambucus Nigra, Silicea, Sulphur, Zincum Gluconicum, Water LIQUID ORAL 20130906 UNAPPROVED DRUG OTHER PharmaCare US, Inc. BRYONIA ALBA ROOT; MATRICARIA RECUTITA; GELSEMIUM SEMPERVIRENS ROOT; PASSIFLORA INCARNATA FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; SILICON DIOXIDE; SULFUR; ZINC GLUCONATE 6; 6; 6; 6; 4; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 52054-107_1f128e35-5f96-45c1-ac0a-cf04ba9161c6 52054-107 HUMAN PRESCRIPTION DRUG EMVERM mebendazole TABLET, CHEWABLE ORAL 20160215 20181130 ANDA ANDA073580 Amedra Pharmaceuticals LLC MEBENDAZOLE 100 mg/1 Antihelminthic [EPC] N 20181231 52054-512_b82965a5-5191-4cc4-93d3-d0671eefa311 52054-512 HUMAN PRESCRIPTION DRUG DEXEDRINE SPANSULE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA NDA017078 Amedra Pharmaceuticals LLC DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 52054-513_b82965a5-5191-4cc4-93d3-d0671eefa311 52054-513 HUMAN PRESCRIPTION DRUG DEXEDRINE SPANSULE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA NDA017078 Amedra Pharmaceuticals LLC DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 52054-514_b82965a5-5191-4cc4-93d3-d0671eefa311 52054-514 HUMAN PRESCRIPTION DRUG DEXEDRINE SPANSULE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA NDA017078 Amedra Pharmaceuticals LLC DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 52054-550_a7ad87db-7e4b-47f0-b92d-32fd839c7ffe 52054-550 HUMAN PRESCRIPTION DRUG ALBENZA albendazole TABLET, FILM COATED ORAL 19960611 NDA NDA020666 Amedra Pharmaceuticals LLC ALBENDAZOLE 200 mg/1 Antihelminthic [EPC],Cytochrome P450 1A Inducers [MoA] N 20181231 52060-001_b4a769a0-5500-45c9-a0fb-ce28edc29f88 52060-001 HUMAN OTC DRUG Spearmint SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20140822 OTC MONOGRAPH FINAL part352 Natural Star Labs, Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g N 20181231 52060-002_b4a769a0-5500-45c9-a0fb-ce28edc29f88 52060-002 HUMAN OTC DRUG Beeswax SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20140822 OTC MONOGRAPH FINAL part352 Natural Star Labs, Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g N 20181231 52060-003_b4a769a0-5500-45c9-a0fb-ce28edc29f88 52060-003 HUMAN OTC DRUG Pomegranate SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20140822 OTC MONOGRAPH FINAL part352 Natural Star Labs, Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g N 20181231 52060-004_b4a769a0-5500-45c9-a0fb-ce28edc29f88 52060-004 HUMAN OTC DRUG Tropical SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20140822 OTC MONOGRAPH FINAL part352 Natural Star Labs, Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g N 20181231 52060-005_b4a769a0-5500-45c9-a0fb-ce28edc29f88 52060-005 HUMAN OTC DRUG Vanilla SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20140822 OTC MONOGRAPH FINAL part352 Natural Star Labs, Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g N 20181231 52069-100_0de91c75-e18d-4f53-a3a9-4e1923c1760a 52069-100 HUMAN OTC DRUG Sofskin Petroleum White Petroleum JELLY TOPICAL 20100310 OTC MONOGRAPH FINAL part347 Nova Petroleum & Chemicals Corporation PETROLATUM 110 g/110g E 20171231 52069-101_adab309b-f25f-47c4-8c8d-0bc328393c48 52069-101 HUMAN OTC DRUG Vaporizing Chest Rub Menthol Camphor Eucalyptus Oil GEL TOPICAL 20100310 OTC MONOGRAPH FINAL part341 Nova Petroleum & Chemicals Corporation CAMPHOR, (+/-)-; MENTHOL; EUCALYPTUS OIL 4.7; 1.1; 1.1 g/110g; g/110g; g/110g E 20171231 52069-102_497e2c81-43cc-4f14-89b3-305a3c325d0a 52069-102 HUMAN OTC DRUG Sofskin Baby Mineral Oil OIL TOPICAL 20100310 OTC MONOGRAPH FINAL part347 Nova Petroleum & Chemicals Corporation MINERAL OIL 1 mL/mL E 20171231 52069-103_d76fa296-06de-496f-97e1-d8d59bb45975 52069-103 HUMAN OTC DRUG Sofskin Baby White Petrolatum JELLY TOPICAL 20100310 OTC MONOGRAPH FINAL part347 Nova Petroleum & Chemicals Corporation PETROLATUM 225 g/225g E 20171231 52069-104_123b71b8-1ca0-4f59-87b4-c35636577bb1 52069-104 HUMAN OTC DRUG Sofskin Ice Analgesic Menthol GEL TOPICAL 20100310 OTC MONOGRAPH FINAL part341 Nova Petroleum & Chemicals Corporation MENTHOL 2.27 g/227g E 20171231 52072-001_a6188dcb-0c69-493a-86bd-72dab233b8ad 52072-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070105 NDA NDA205865 Dressel Welding Supply, Inc. OXYGEN 992 L/1000L N 20181231 52072-002_9d29996b-3e96-4f06-b4cf-00a3c3c081ba 52072-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 20041223 UNAPPROVED MEDICAL GAS Dressel Welding Supply, Inc. OXYGEN 992 L/1000L E 20171231 52072-003_25026b0a-fa72-471d-9321-388e5b8a70fe 52072-003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20101209 NDA NDA205866 Dressel Welding Supply, Inc. NITROGEN 992 mL/L N 20181231 52083-055_fafb4f69-8751-4632-909a-5f174ca45fae 52083-055 HUMAN OTC DRUG Supress DX Pediatric Drops Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SYRUP ORAL 20110329 OTC MONOGRAPH FINAL part341 KRAMER NOVIS GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 50; 5; 2.5 mg/mL; mg/mL; mg/mL N 20181231 52083-056_51d2a65a-0c18-4966-8ab9-8265e4b92944 52083-056 HUMAN OTC DRUG SUPRESS-PE Pediatric Guiafenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20140114 OTC MONOGRAPH FINAL part341 Kramer Novis GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 50; 2.5 mg/mL; mg/mL N 20181231 52083-057_f3752319-1292-4d33-8d94-37b5a295b265 52083-057 HUMAN OTC DRUG SUPRESS A Dexbromopheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20120801 OTC MONOGRAPH FINAL part341 Kramer Novis DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 10; 5 mg/mL; mg/mL; mg/mL N 20181231 52083-058_e4c6e761-27c6-4453-9026-759ea0bba014 52083-058 HUMAN OTC DRUG Supress DM dextromethorphan hydrobromide, guaifenesin SYRUP ORAL 20131002 OTC MONOGRAPH FINAL part341 KRAMER NOVIS GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 50; 5 mg/mL; mg/mL N 20181231 52083-231_de9851ac-7c90-43e1-a3d3-ccadba200f0b 52083-231 HUMAN OTC DRUG Tussi Pres guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide SYRUP ORAL 20110328 OTC MONOGRAPH FINAL part341 Kramer Novis GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 200; 5; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-232_f4ef1cfa-9ccf-4d9c-a438-d8770eb96165 52083-232 HUMAN OTC DRUG TUSSI PRES PEDIATRIC GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE SYRUP ORAL 20110324 OTC MONOGRAPH FINAL part341 KRAMER NOVIS GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 75; 2.5; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-233_150bf86f-6e18-499c-bab4-5e8f9bf73380 52083-233 HUMAN OTC DRUG Tussi Pres guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide SYRUP ORAL 20110328 OTC MONOGRAPH FINAL part341 Kramer Novis GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 200; 5; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 52083-237_7fbc7d6b-f82a-4007-8d20-db7c0394752e 52083-237 HUMAN OTC DRUG Tussi Pres B dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride SYRUP ORAL 20110329 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 20; 4; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-239_01045808-544c-4b23-88dc-041e37c3e19f 52083-239 HUMAN OTC DRUG TUSICOF dextromethorphan, guaifenesin, and phenylephrine SYRUP ORAL 20100817 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-242_e9fb4163-0958-4473-ba07-394037bb2662 52083-242 HUMAN OTC DRUG Myco Nail A Antifungal Solution Undecylenic acid LIQUID TOPICAL 20140114 OTC MONOGRAPH FINAL part333C Kramer Novis UNDECYLENIC ACID 250 mg/mL N 20181231 52083-249_eeeb8506-0c6d-4259-93dd-0744aa1fe17c 52083-249 HUMAN OTC DRUG Guaifenesin Phenylephrine Dextromethorphan Guaifenesin, phenylephrine HCL, Dextromethorphan TABLET, COATED ORAL 20120718 OTC MONOGRAPH FINAL part341 Kramer Novis. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 400; 20; 10 mg/1; mg/1; mg/1 E 20171231 52083-263_8817129c-6c85-45f6-bed0-24ad36016917 52083-263 HUMAN OTC DRUG BICARSIM FORTE Simethicone TABLET ORAL 20160406 OTC MONOGRAPH FINAL part332 KRAMER NOVIS DIMETHICONE 125 mg/1 N 20181231 52083-289_14da55c9-8308-47f9-90a8-6aa3f709b6b4 52083-289 HUMAN OTC DRUG Tusicof Guaifenesin, phenylephrine HCL, Dextromethorphan TABLET, COATED ORAL 20120718 OTC MONOGRAPH FINAL part341 Kramer Novis. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 400; 20; 10 mg/1; mg/1; mg/1 N 20181231 52083-400_0ce3d63e-43c0-43d9-a1ff-cb48da835eee 52083-400 HUMAN OTC DRUG ZYNCOF Dextromethorphan HBr and Guaifenesin SYRUP ORAL 20110601 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/5mL; mg/5mL N 20181231 52083-410_1563f75c-9151-467a-8936-a9ac42598054 52083-410 HUMAN OTC DRUG ZYNCOF Dextromethorphan Hydrobromide, Guaifenesin TABLET ORAL 20150520 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 52083-410_e6c1222a-c661-48ce-957c-acd890157bb7 52083-410 HUMAN OTC DRUG ZYNCOF Dextromethorphan Hydrobromide, Guaifenesin TABLET ORAL 20150626 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 52083-481_b61f9139-5d97-453f-a257-3e6d608c73cc 52083-481 HUMAN OTC DRUG Dologen Dexbrompheniramine Maleate, Acetaminophen TABLET ORAL 20111011 OTC MONOGRAPH FINAL part341 Kramer Novis DEXBROMPHENIRAMINE MALEATE; ACETAMINOPHEN 2; 650 mg/1; mg/1 N 20181231 52083-482_2a392856-169a-4401-a461-4ab618a7529e 52083-482 HUMAN OTC DRUG Dologen 325 Acetaminophen, Dexbrompheniramine TABLET ORAL 20140827 OTC MONOGRAPH FINAL part341 Kramer Novis ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE 325; 1 mg/1; mg/1 N 20181231 52083-600_f0ce44de-6405-4d1d-a431-31cc7492c890 52083-600 HUMAN OTC DRUG G-ZYNCOF Dextromethorphan HBr and Guaifenesin SYRUP ORAL 20121203 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/5mL; mg/5mL N 20181231 52083-601_73d63dc1-4c0a-42cb-af2e-4f6815d89fd3 52083-601 HUMAN OTC DRUG G Tron Guaifenesin Dextromethorphan SYRUP ORAL 20120918 OTC MONOGRAPH FINAL part341 Kramer Novis GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL E 20171231 52083-602_cd027353-8669-4aac-b94f-d2ceb7456ef4 52083-602 HUMAN OTC DRUG G-P-TUSS DXP dexbrompheniramine, dextromethorphan, and phenylephrine SYRUP ORAL 20130124 OTC MONOGRAPH FINAL part341 Kramer Novis DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 20; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 52083-617_8c094829-405b-44b9-9ab3-1dd2910a0994 52083-617 HUMAN OTC DRUG Tusslin TR dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride TABLET ORAL 20150504 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 28; 388; 10 1/1; 1/1; 1/1 N 20181231 52083-620_6d01b9b3-f258-4843-9a07-9627271cee67 52083-620 HUMAN OTC DRUG Pecgen DMX guaifenesin,Dextromethorphan hydrobromide SYRUP ORAL 20110329 OTC MONOGRAPH FINAL part341 KRAMER NOVIS GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 125; 15 mg/5mL; mg/5mL E 20171231 52083-622_9ea5374b-e7d7-4647-b99a-7eca40aecb0d 52083-622 HUMAN OTC DRUG Tusslin Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride SYRUP ORAL 20140701 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 28; 388; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-623_21bcaf13-5dfa-40b4-b74b-169e27280fc3 52083-623 HUMAN OTC DRUG Tusslin Pediatric Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20140127 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 7.5; 88; 2.5 mg/mL; mg/mL; mg/mL N 20181231 52083-625_09a988e4-f6a5-4c6c-bfce-0807629463a4 52083-625 HUMAN OTC DRUG ABATUSS DMX DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20140525 OTC MONOGRAPH FINAL part341 Kramer Novis DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15; 30 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-628_027d6dbd-3e19-4038-924c-925dceb48911 52083-628 HUMAN OTC DRUG PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20140808 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 187; 30 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-630_385d1f95-674f-48f8-8060-bf26894a8a42 52083-630 HUMAN OTC DRUG PECGEN DMX Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20150401 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 187 mg/5mL; mg/5mL N 20181231 52083-632_80efc77a-89a1-4630-9db4-6055cede83b8 52083-632 HUMAN OTC DRUG Presgen guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide SYRUP ORAL 20110328 OTC MONOGRAPH FINAL part341 Kramer Novis GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 200; 5; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-637_132984c0-5d7b-4971-a1e8-a4a1dcc20041 52083-637 HUMAN OTC DRUG Presgen B dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride SYRUP ORAL 20110329 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 20; 4; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-639_e6cf0aff-a481-4eec-bc90-77f5412c83f8 52083-639 HUMAN OTC DRUG G-TUSICOF dextromethorphan, guaifenesin, and phenylephrine SYRUP ORAL 20120924 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-641_c8298299-37cd-43d0-8514-592e11645226 52083-641 HUMAN OTC DRUG Desgen Pediatric Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20140127 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/mL; mg/mL; mg/mL N 20181231 52083-645_35912503-cc63-476d-8078-42856d398ccd 52083-645 HUMAN OTC DRUG Desgen DM dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride SYRUP ORAL 20131002 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 100; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 52083-646_44763d19-83b8-4748-96b6-6e0b286c972e 52083-646 HUMAN OTC DRUG DESGEN DM Dextromethorphan HBr ,Guaifenesin ,Phenylephrine HCl SOLUTION ORAL 20141018 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-648_e0e3af62-0c69-4129-baac-4c49ffc4e345 52083-648 HUMAN OTC DRUG DESGEN DM Tabs DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE TABLET ORAL 20150826 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 200; 30 mg/1; mg/1; mg/1 N 20181231 52083-650_12ea5981-7b12-439f-8c75-174002601cdb 52083-650 HUMAN OTC DRUG GENCONTUSS CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE SOLUTION ORAL 20150608 OTC MONOGRAPH FINAL part341 KRAMER NOVIS CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 52083-653_bc93fc8b-940a-4755-a968-c11bf7e28a46 52083-653 HUMAN OTC DRUG PRESGEN PEDIATRIC GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE SYRUP ORAL 20110324 OTC MONOGRAPH FINAL part341 KRAMER NOVIS GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 75; 2.5; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-655_106420c5-210e-40c3-9943-6a46c795114a 52083-655 HUMAN OTC DRUG G-Supress DX Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SYRUP ORAL 20110329 OTC MONOGRAPH FINAL part341 KRAMER NOVIS GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 50; 5; 2.5 mg/mL; mg/mL; mg/mL N 20181231 52083-660_ca3816c8-45a5-4f72-9649-3a36057a7097 52083-660 HUMAN OTC DRUG Sorbugen dextromethorphan hydrobromide, glycerol guaiacolate SYRUP ORAL 20141008 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 15; 150 mg/7.5mL; mg/7.5mL N 20181231 52083-675_bb2fe455-c804-484e-93ba-2ae09e9ccbaf 52083-675 HUMAN OTC DRUG ABANATUSS PED CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE SOLUTION ORAL 20150701 OTC MONOGRAPH FINAL part341 KRAMER NOVIS CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 25; 2; 60 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-678_f75884fc-b31c-44cd-906e-bf905046879d 52083-678 HUMAN OTC DRUG G-TRON PED Dextromethorphan Hbr, Guiafenesin, Phenylephrine HCl SOLUTION ORAL 20140127 OTC MONOGRAPH FINAL part341 Kramer Novis DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 350; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 52083-679_fa63c384-2ba4-49bd-8d18-519356dbcdc9 52083-679 HUMAN OTC DRUG G-TRON PEDIATRIC DROPS Dextromethorphan HBr,Guaifenesin,Phenylephrine HCL SOLUTION/ DROPS NASAL 20140909 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/mL; mg/mL; mg/mL N 20181231 52083-680_694dfda1-fb06-47c0-b66c-f54ad9c90efb 52083-680 HUMAN OTC DRUG DERMOGEN ZINC OXIDE CREAM TOPICAL 20160404 OTC MONOGRAPH FINAL part347 KRAMER NOVIS ZINC OXIDE 15.25 g/100g N 20181231 52083-681_b4588468-872d-4fbb-a9ec-b0daf6a951cf 52083-681 HUMAN OTC DRUG G-Dologen acetaminophen, dexbrompheniramine maleate TABLET ORAL 20140827 OTC MONOGRAPH FINAL part341 KRAMER NOVIS DEXBROMPHENIRAMINE MALEATE; ACETAMINOPHEN 2; 650 mg/1; mg/1 N 20181231 52083-685_94707237-8a5e-4bae-acf5-e26ba6bba846 52083-685 HUMAN OTC DRUG ABANATUSS PED DROPS CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE SOLUTION ORAL 20150805 OTC MONOGRAPH FINAL part341 KRAMER NOVIS CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 6.25; .5; 15 mg/mL; mg/mL; mg/mL N 20181231 52083-713_aa6eff15-6592-4199-b37b-bad0931ad2dd 52083-713 HUMAN OTC DRUG Gumsol Benzocaine, Zinc Chloride SOLUTION ORAL 20140228 OTC MONOGRAPH NOT FINAL part356 Kramer Novis BENZOCAINE; ZINC CHLORIDE 1.5; .03 g/30mL; g/30mL N 20181231 52083-714_563ff687-4fe7-4f67-9669-26b0795b4882 52083-714 HUMAN OTC DRUG Gumsol Benzocaine, Zinc Chloride SPRAY ORAL 20140228 OTC MONOGRAPH NOT FINAL part356 Kramer Novis BENZOCAINE; ZINC CHLORIDE 1.5; .03 g/30mL; g/30mL N 20181231 52084-0001_df120de1-bc45-434e-946b-9a5585fe0ad7 52084-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100105 UNAPPROVED MEDICAL GAS Morgan Medical Equipment & Supply OXYGEN 99 L/100L E 20171231 52085-001_5d21586b-622f-4425-aad6-0bdfa251e721 52085-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20070401 UNAPPROVED MEDICAL GAS Analgesic Services Inc. dba ASI Medical OXYGEN 99 L/100L E 20171231 52085-002_76cc375e-fdc8-4909-83d4-5e122c099c92 52085-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20131201 UNAPPROVED MEDICAL GAS Analgesic Services Inc. dba ASI Medical NITROGEN 99 L/100L E 20171231 52086-001_730ed554-5009-476b-856a-5e4c264eeadb 52086-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830908 NDA NDA205889 Helget Gas Products OXYGEN 99.9 L/L N 20181231 52086-002_cf0caf47-3865-48e6-bde7-3a02a39151e0 52086-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19830908 NDA NDA205891 Helget Gas Products NITROGEN 99.9 L/L N 20181231 52086-003_f701c7b1-df67-4e7b-835f-41d7b04191e7 52086-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19830908 NDA NDA206014 Helget Gas Products NITROUS OXIDE 99.5 L/L N 20181231 52087-0001_36a1dc4b-02ac-495e-b2af-2ab8c275de11 52087-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100224 UNAPPROVED MEDICAL GAS Legacy Durable Medical Equipment Inc OXYGEN 99 L/100L E 20171231 52096-001_e2397e82-8438-4998-9a98-812e5ee763e4 52096-001 HUMAN PRESCRIPTION DRUG PerioChip Chlorhexidine Gluconate INSERT, EXTENDED RELEASE PERIODONTAL 19980501 NDA NDA020774 Adrian Pharmaceuticals, LLC CHLORHEXIDINE GLUCONATE 2.5 mg/1 Decreased Cell Wall Integrity [PE] E 20171231 52099-0008_a68aa42b-9cac-4bae-9a12-8cfaf53e828f 52099-0008 HUMAN OTC DRUG Glucosamine Cream EXTRA STRENGTH HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part348 Q.A. Laboratories HISTAMINE DIHYDROCHLORIDE .05 g/100g N 20181231 52099-7005_ccc30ded-2bb9-41eb-bd2f-9f3d370b769a 52099-7005 HUMAN OTC DRUG footshield plus Tolnaftate CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part333C Q.A. Laboratories TOLNAFTATE 1 g/100g N 20181231 52099-8000_a8c8b241-6d5d-476a-ad04-e9b73830116f 52099-8000 HUMAN OTC DRUG FREEZIN COLD TOAST METHYL SALICYLATE CREAM TOPICAL 20120612 OTC MONOGRAPH FINAL part348 Q.A. Laboratories METHYL SALICYLATE; MENTHOL 31; 11 g/100g; g/100g N 20181231 52099-8005_2c7dc070-a6b5-4bb2-a9d4-b9b6c861e868 52099-8005 HUMAN OTC DRUG SCREAMIN HOT TOAST CAPSAICIN CREAM TOPICAL 20120619 OTC MONOGRAPH FINAL part348 Q.A. Laboratories CAPSAICIN 3 g/100g N 20181231 52099-8010_e3e1bce6-42fe-45f2-8f34-a2be39dacbb3 52099-8010 HUMAN OTC DRUG SCREAMIN MENTHOL TOAST MENTHOL CREAM TOPICAL 20120621 OTC MONOGRAPH FINAL part348 Q.A. Laboratories MENTHOL 4 g/100g N 20181231 52102-1001_8135482e-b382-4c77-ac02-b1a649837a8f 52102-1001 HUMAN OTC DRUG Kimchi Vitamin chewable multivitamin vitamin TABLET, CHEWABLE ORAL 20100318 UNAPPROVED DRUG OTHER Tobico LACTIC ACID; ASCORBIC ACID; THIAMINE; PYRIDOXINE; VITAMIN A; ALPHA-TOCOPHEROL; FOLIC ACID; COLLAGENASE; RIBOFLAVIN; CHOLECALCIFEROL; NIACINAMIDE 30; 180; .195; .285; .675; 1.875; .03; 5.625; .24; .375; .045 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 E 20171231 52116-7100_e599e769-9299-4cc9-8374-9116cf62f589 52116-7100 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20110505 OTC MONOGRAPH NOT FINAL part333E MAC Medical Supply Company, Inc. BENZALKONIUM CHLORIDE 1.2478 g/L N 20181231 52118-001_7bc0575c-0a78-4e3c-820c-f0bcc9f8c99f 52118-001 HUMAN PRESCRIPTION DRUG Vibativ telavancin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091105 NDA NDA022110 Theravance, Inc. TELAVANCIN HYDROCHLORIDE 15 mg/mL Lipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [Chemical/Ingredient] N 20181231 52118-002_7bc0575c-0a78-4e3c-820c-f0bcc9f8c99f 52118-002 HUMAN PRESCRIPTION DRUG Vibativ telavancin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091105 NDA NDA022110 Theravance, Inc. TELAVANCIN HYDROCHLORIDE 15 mg/mL Lipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [Chemical/Ingredient] N 20181231 52120-100_85dfc4ff-e676-4dac-9dd8-63c15af9842c 52120-100 HUMAN PRESCRIPTION DRUG Ultacan Forte articaine hydrochloride, epinephrine bitartrate INJECTION, SOLUTION SUBMUCOSAL 20170711 ANDA ANDA201750 HANSAmed, Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .018 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 52120-200_85dfc4ff-e676-4dac-9dd8-63c15af9842c 52120-200 HUMAN PRESCRIPTION DRUG Ultacan articaine hydrochloride, epinephrine bitartrate INJECTION, SOLUTION SUBMUCOSAL 20170711 ANDA ANDA201751 HANSAmed, Inc. ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .009 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 52123-010_53946273-0e5b-4e0c-9d44-c29a931a5795 52123-010 HUMAN OTC DRUG PURE RED GINSENG CLEANSING Witch Hazel AEROSOL, FOAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 SOBAEK INSAM FARMING COOPERATIVE CORPORATION WITCH HAZEL .12 g/120mL N 20181231 52123-020_849cca7e-4620-4de9-911b-7bcae0169b93 52123-020 HUMAN OTC DRUG PURE RED GINSENG Witch Hazel SOAP TOPICAL 20120601 OTC MONOGRAPH FINAL part347 SOBAEK INSAM FARMING COOPERATIVE CORPORATION WITCH HAZEL .1 g/100g N 20181231 52123-030_5604f0e0-729a-4034-8bc1-0888b2bd1536 52123-030 HUMAN OTC DRUG Red Ginseng Pure Red Lively Water Allantoin CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 SOBAEK INSAM FARMING COOPERATIVE CORPORATION ALLANTOIN .25 g/50g N 20181231 52123-040_0bd31cd5-7262-48ec-a5f8-66f9d543897e 52123-040 HUMAN OTC DRUG Red Ginseng Pure Red Classic Light Titanium Dioxide LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SOBAEK INSAM FARMING COOPERATIVE CORPORATION TITANIUM DIOXIDE 4 g/100g N 20181231 52124-0001_e4f2d7c1-511f-4c61-b38c-567727801f1f 52124-0001 HUMAN OTC DRUG Antiseptic BENZALKONIUM CHLORIDE SWAB TOPICAL 20100423 OTC MONOGRAPH NOT FINAL part333A Genuine First Aid LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 52124-0002_61905da5-90f8-8cd2-e053-2a91aa0a0120 52124-0002 HUMAN OTC DRUG Alcohol Cleansing Pad ISOPROPYL ALCOHOL LIQUID TOPICAL 20100423 OTC MONOGRAPH NOT FINAL part333A Genuine First Aid LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 52124-0003_696ebd38-f3de-4eab-9534-e229fac2bf86 52124-0003 HUMAN OTC DRUG Genuine Triple Antibiotic BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE OINTMENT TOPICAL 20100216 OTC MONOGRAPH FINAL part333B Genuine First Aid LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 52124-0004_fbc705dd-eaf8-41cf-9f8b-59032951c9a7 52124-0004 HUMAN OTC DRUG Genuine First Aid Burn Antiseptic Pain Relief With Aloe BENZALKONIUM CHLORIDE, LIDOCAINE CREAM TOPICAL 20100423 OTC MONOGRAPH FINAL part333A Genuine First Aid BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; .5 g/100g; g/100g E 20171231 52124-0005_c7bbb831-ecd8-4c13-8aa7-02c2b8f99f1f 52124-0005 HUMAN OTC DRUG Sterile Isotonic Buffered Genuine Eyewash WATER LIQUID OPHTHALMIC 20100216 OTC MONOGRAPH FINAL part349 Genuine First Aid WATER 98.16 mL/100mL E 20171231 52124-0006_6191106d-2f77-26c0-e053-2a91aa0a5e78 52124-0006 HUMAN OTC DRUG Genuine Hand Sanitizer ALCOHOL GEL TOPICAL 20100423 OTC MONOGRAPH NOT FINAL part333A Genuine First Aid LLC ALCOHOL 62 g/100g N 20181231 52124-0007_9e4b519d-9710-474a-95bb-d7aa44c6aaf3 52124-0007 HUMAN OTC DRUG Hydrocortisone HYDROCORTISONE ACETATE CREAM TOPICAL 20100423 OTC MONOGRAPH FINAL part348 Genuine First Aid HYDROCORTISONE ACETATE 1 g/100g E 20171231 52124-0008_b994d7dc-664e-4fdf-9b36-f3af79dbe6e5 52124-0008 HUMAN OTC DRUG Insect Sting Relief Pad BENZOCAINE,ALCOHOL SWAB TOPICAL 20100423 OTC MONOGRAPH FINAL part348 Genuine First Aid LLC BENZOCAINE; ALCOHOL 6; 60 mL/100mL; mL/100mL N 20181231 52124-0009_61919df7-c078-0cb9-e053-2a91aa0a5e1d 52124-0009 HUMAN OTC DRUG Ibuprofen IBUPROFEN TABLET ORAL 20100217 ANDA ANDA075010 Genuine First Aid LLC IBUPROFEN 200 mg/1 N 20181231 52124-0010_61956c46-fd9a-ce9d-e053-2991aa0af1fb 52124-0010 HUMAN OTC DRUG NON-ASPIRIN ACETAMINOPHEN TABLET ORAL 20100423 OTC MONOGRAPH NOT FINAL part343 Genuine First Aid LLC ACETAMINOPHEN 325 mg/1 N 20181231 52124-0011_61952fe1-815b-ff6e-e053-2a91aa0a2d58 52124-0011 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET ORAL 20100423 OTC MONOGRAPH FINAL part343 Genuine First Aid LLC ASPIRIN 325 mg/1 N 20181231 52124-0012_619521d9-1e93-8274-e053-2991aa0ad960 52124-0012 HUMAN OTC DRUG Chewable Aspirin ASPIRIN TABLET, CHEWABLE ORAL 20100402 OTC MONOGRAPH FINAL part343 Genuine First Aid LLC ASPIRIN 81 mg/1 N 20181231 52124-0101_bd6f97ab-5ec5-410a-b95b-b252cdbd745c 52124-0101 HUMAN OTC DRUG GFA 42 Essential First Aid Items ISOPROPYL ALCOHOL KIT 20100429 OTC MONOGRAPH FINAL part345 Genuine First Aid LLC N 20181231 52124-0102_6d3dcefe-c7d8-4eeb-bdd7-23d917db18d2 52124-0102 HUMAN OTC DRUG FIRST AID Contains 101 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100424 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-0103_6d2ed56c-dcca-441e-af47-d383cc5e4eb2 52124-0103 HUMAN OTC DRUG FIRST AID Contains 101 PIECES HARDCASE BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100424 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-0105_d47bffdf-e2de-4085-8421-25e98c7d534a 52124-0105 HUMAN OTC DRUG FIRST AID Contains 303 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100424 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-0106_3d79ae08-e940-4685-8ed1-a2a3bdf213a2 52124-0106 HUMAN OTC DRUG FIRST AID Contains 303 PIECES HARDCASE BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOTROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100428 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-0107_7e2f8c52-dae3-4e68-84b9-0e7701c46118 52124-0107 HUMAN OTC DRUG FIRST AID Contains 404 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOTROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100425 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-0109_3ee9f2db-5340-48a9-8333-c1083135d565 52124-0109 HUMAN OTC DRUG GENUINE FIRST AID Emergency Preparedness Contains 167 Pieces BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN, KIT 20100514 OTC MONOGRAPH FINAL part345 Genuine First Aid LLC N 20181231 52124-0110_fa2e3b78-659e-4e54-a9a5-88d8598fa671 52124-0110 HUMAN OTC DRUG GENUINE FIRST AID Emergency Preparedness Contains 167 PIECES HARDCASE BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100428 OTC MONOGRAPH FINAL part345 Genuine First Aid LLC N 20181231 52124-0111_fd9dd0ed-a7e0-44c8-9c21-4b03b32f8cad 52124-0111 HUMAN OTC DRUG 10 Person ANSI BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN KIT 20100424 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-0112_3db06e79-e87f-4e44-ac20-c692118b932e 52124-0112 HUMAN OTC DRUG 25 Person ANSI BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN, ISOPROPYL ALCOHOL KIT 20100425 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-0113_2a883d44-4542-4a0e-8202-6a70e159ee52 52124-0113 HUMAN OTC DRUG 50 Person ANSI BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN, ISOPROPYL ALCOHOL KIT 20100602 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-0114_494c6e04-0310-483d-9d34-bd46dc804aff 52124-0114 HUMAN OTC DRUG Protection ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100423 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-0115_eed408f2-0c94-4432-819f-381b88724a08 52124-0115 HUMAN OTC DRUG Emergency Preparedness BENZALKONIUM CHLORIDE,BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE, ETHYL ALCOHOL KIT 20100423 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-0116_27826c7e-54b3-47bb-ab49-d58dac48fb63 52124-0116 HUMAN OTC DRUG Small Cuts and Burns BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20100423 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-0117_d1e32dcf-dca4-450c-b27e-226352540381 52124-0117 HUMAN OTC DRUG Medium Cuts and Scratches BENZALKONIUM CHLORIDE, WATER KIT 20100423 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-0118_91aa1891-7ebd-49e8-b874-e0b550b09bd6 52124-0118 HUMAN OTC DRUG Auto 157 BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL, IBUPROFEN, ACETAMINOPHEN, ASPIRIN KIT 20100507 OTC MONOGRAPH FINAL part333 Genuine First Aid LLC N 20181231 52124-1000_63082ebc-35d7-4171-b4d3-5f0d76b217f7 52124-1000 HUMAN OTC DRUG Genuine First Aid - Auto First Aid BENZALKONIUM CHLORIDE, IBUPROFEN, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN KIT 20110111 OTC MONOGRAPH NOT FINAL part333E Genuine First Aid, LLC E 20171231 52124-1023_a514e24f-246f-4eae-98fc-71a80c66df04 52124-1023 HUMAN OTC DRUG GFA First Aid Kit Essentials - 33 Pieces ASPIRIN, IBUPROFEN, ACETAMINOPHEN, ALCOHOL, BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20110818 OTC MONOGRAPH NOT FINAL part333B Genuine First Aid, LLC N 20181231 52124-1154_f1c6e667-8c30-4519-a961-98546c966463 52124-1154 HUMAN OTC DRUG GFA First Aid 75 Person Metal Case BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE, POVIDONE-IODINE, WATER, ALCOHOL, ASPIRIN, IBUPROFEN, ACETAMINOPHEN, BENZOCAINE, ALCOHOL KIT 20110503 OTC MONOGRAPH FINAL part333E Genuine First Aid, LLC E 20171231 52124-1164_6b08d42c-5fa6-48b8-9a61-52d8c8145f99 52124-1164 HUMAN OTC DRUG GFA First Aid BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B KIT 20110413 OTC MONOGRAPH FINAL part333E Genuine First Aid, LLC E 20171231 52124-1165_18cdc495-5dca-4b22-98f8-3f709c228bc5 52124-1165 HUMAN OTC DRUG GFA First Aid 16 Unit Metal Case BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B KIT 20110503 OTC MONOGRAPH FINAL part333E Genuine First Aid, LLC E 20171231 52124-1166_da4c53fb-cb3b-4efa-a402-03b644217945 52124-1166 HUMAN OTC DRUG GFA First Aid 24 Unit Metal Case BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, POVIDONE-IODINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B KIT 20110503 OTC MONOGRAPH FINAL part333E Genuine First Aid, LLC E 20171231 52124-1167_e1829c88-e16f-40e5-9cd9-3fd62e0004f4 52124-1167 HUMAN OTC DRUG GFA First Aid 36 Unit Metal Case BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, LIDOCAINE, POVIDONE-IODINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B KIT 20110504 OTC MONOGRAPH FINAL part333E Genuine First Aid, LLC E 20171231 52124-1200_aca196dc-cdfb-4702-a04d-72a81b70d4d7 52124-1200 HUMAN OTC DRUG Genuine First Aid - Home First Aid BENZALKONIUM CHLORIDE, IBUPROFEN, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, ACETAMINOPHEN KIT 20110111 OTC MONOGRAPH NOT FINAL part333E Genuine First Aid, LLC E 20171231 52124-2901_832bed96-a18f-47af-8b24-848a267eee5b 52124-2901 HUMAN OTC DRUG Povidone-Iodine Prep POVIDONE-IODINE SWAB TOPICAL 20110404 OTC MONOGRAPH NOT FINAL part333E Genuine First Aid, LLC POVIDONE-IODINE 1 mL/100mL E 20171231 52124-2903_e83702cb-1a10-4c78-b809-c0341cc507d0 52124-2903 HUMAN OTC DRUG Genuine Hydrocortisone HYDROCORTISONE CREAM TOPICAL 20110329 OTC MONOGRAPH NOT FINAL part348 Genuine First Aid, LLC HYDROCORTISONE ACETATE 1 g/100g E 20171231 52124-2906_12fe8e70-3376-4bd4-9239-4eafc393db76 52124-2906 HUMAN OTC DRUG Genuine Hand Sanitizer ALCOHOL GEL TOPICAL 20110328 OTC MONOGRAPH NOT FINAL part333A Genuine First Aid, LLC ALCOHOL 62 g/100g E 20171231 52124-3201_f155deda-b928-428a-b570-79d5d556b217 52124-3201 HUMAN OTC DRUG Ammonia Pad AMMONIA INHALANT RESPIRATORY (INHALATION) 20110404 UNAPPROVED DRUG OTHER Genuine First Aid, LLC AMMONIA 10 mL/100mL E 20171231 52124-4001_c5160f28-9ec8-4ea0-b7de-30e215a4f371 52124-4001 HUMAN OTC DRUG Ready America First Aid Pocket - 33 Pieces ASPIRIN, IBUPROFEN, ACETAMINOPHEN, ALCOHOL, BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE KIT 20130109 OTC MONOGRAPH NOT FINAL part333B Genuine First Aid, LLC E 20171231 52124-4002_9cd0d6a7-8614-4eaf-96ea-d42eb5f97098 52124-4002 HUMAN OTC DRUG Ready America First Aid Outdoor- 107 Pieces ASPIRIN, IBUPROFEN, ACETAMINOPHEN, ALCOHOL, BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE, BENZOCAINE, ALCOHOL KIT 20130109 OTC MONOGRAPH NOT FINAL part333B Genuine First Aid, LLC E 20171231 52124-4016_3a45ef1e-0890-4c9f-a8b7-f3ecc8730bfe 52124-4016 HUMAN OTC DRUG Genuine First Aid Industrial First Aid ASPIRIN, ACETAMINOPHEN, IBUPROFEN, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, BENZALKONIUM CHLORIDE, LIDOCAINE, BENZALKONIUM CHLORIDE KIT 20110503 OTC MONOGRAPH FINAL part333E Genuine First Aid, LLC E 20171231 52125-026_3ebfd422-4f58-1eb0-e054-00144ff8d46c 52125-026 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20120721 UNAPPROVED DRUG OTHER REMEDYREPACK INC. PHENOBARBITAL 32.4 mg/1 CIV E 20171231 52125-062_564787d7-e507-1e7d-e054-00144ff88e88 52125-062 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20120720 ANDA ANDA084113 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 52125-067_30c5aeb6-053d-30a5-e054-00144ff8d46c 52125-067 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20130222 NDA NDA021153 REMEDYREPACK INC. ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 52125-068_8ac561fd-af0e-4122-91d2-842969afd224 52125-068 HUMAN PRESCRIPTION DRUG Zithromax azithromycin TABLET, FILM COATED ORAL 20130312 NDA NDA050711 REMEDYREPACK INC. AZITHROMYCIN, UNSPECIFIED FORM 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 52125-073_4c5a38b4-5c3a-22f4-e054-00144ff88e88 52125-073 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20120716 ANDA ANDA040103 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 52125-087_564787d7-e550-1e7d-e054-00144ff88e88 52125-087 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120720 ANDA ANDA078525 REMEDYREPACK INC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 52125-089_5649ad9f-1428-5e65-e054-00144ff88e88 52125-089 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20120723 ANDA ANDA077627 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 52125-105_4bb70873-c550-113c-e054-00144ff88e88 52125-105 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20120719 ANDA ANDA074305 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 52125-110_3aa5456c-f0d4-4e07-9728-5f9c44139227 52125-110 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20130329 ANDA ANDA076119 REMEDYREPACK INC. MIRTAZAPINE 45 mg/1 E 20171231 52125-118_3771c177-35bb-57c4-e054-00144ff88e88 52125-118 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20130417 ANDA ANDA040209 REMEDYREPACK INC. TRIFLUOPERAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 52125-119_63287581-9df2-f2f9-e053-2991aa0a6bc4 52125-119 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20120719 ANDA ANDA076373 REMEDYREPACK INC. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 52125-138_45b4a066-b3bd-4176-e054-00144ff88e88 52125-138 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20120720 ANDA ANDA084114 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 52125-160_5649ad9f-146a-5e65-e054-00144ff88e88 52125-160 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20120807 ANDA ANDA040684 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 52125-169_47820c66-7ee9-63ae-e054-00144ff88e88 52125-169 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20120821 ANDA ANDA040103 REMEDYREPACK INC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 52125-190_47820c66-7f45-63ae-e054-00144ff88e88 52125-190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120821 ANDA ANDA074201 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52125-200_49daa1e4-d45a-658a-e054-00144ff88e88 52125-200 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120827 ANDA ANDA201190 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 52125-202_565821f3-5395-455f-e054-00144ff88e88 52125-202 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20120827 ANDA ANDA040756 REMEDYREPACK INC. FOLIC ACID 1 mg/1 N 20181231 52125-204_5657a947-54fe-66c4-e054-00144ff8d46c 52125-204 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120823 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 52125-205_56577c54-1ac2-2486-e054-00144ff88e88 52125-205 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20170809 ANDA ANDA083177 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 52125-210_63192335-8278-5c10-e053-2a91aa0a4ff8 52125-210 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20120829 ANDA ANDA076373 REMEDYREPACK INC. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 52125-211_488509f7-0a55-0a75-e054-00144ff88e88 52125-211 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120824 ANDA ANDA078866 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 52125-216_4874a6e5-e78c-1253-e054-00144ff8d46c 52125-216 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20120821 NDA AUTHORIZED GENERIC NDA020504 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 52125-222_471c8f96-4b7a-6e8e-e054-00144ff8d46c 52125-222 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120912 ANDA ANDA091038 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 52125-236_381463a4-cac1-2254-e054-00144ff8d46c 52125-236 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20140904 ANDA ANDA088042 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52125-253_47829c37-6a49-739a-e054-00144ff88e88 52125-253 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20120924 NDA NDA021446 REMEDYREPACK INC. PREGABALIN 150 mg/1 CV N 20181231 52125-257_3adba400-c147-2bb8-e054-00144ff8d46c 52125-257 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20121008 ANDA ANDA075133 REMEDYREPACK INC. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 52125-266_499dc803-2e6d-0b9b-e054-00144ff88e88 52125-266 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20121009 ANDA ANDA079098 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52125-282_33462ee4-0852-1e52-e054-00144ff8d46c 52125-282 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 20130507 NDA NDA018558 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 52125-284_5658e911-e4c3-2c89-e054-00144ff8d46c 52125-284 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20121022 ANDA ANDA084112 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 52125-287_565be502-9b46-3bde-e054-00144ff8d46c 52125-287 HUMAN OTC DRUG SudoGest Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130213 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 52125-293_565966b5-9e8f-4142-e054-00144ff8d46c 52125-293 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20121226 ANDA ANDA078154 REMEDYREPACK INC. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 52125-307_48acf3cf-6cfe-0da5-e054-00144ff88e88 52125-307 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 20121031 NDA NDA021087 REMEDYREPACK INC. OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 52125-321_4872922d-48d4-00b2-e054-00144ff88e88 52125-321 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20111107 ANDA ANDA075752 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 52125-330_4872922d-48bf-00b2-e054-00144ff88e88 52125-330 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20121127 ANDA ANDA040103 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 52125-336_4898f82c-11ef-3efe-e054-00144ff88e88 52125-336 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20121129 ANDA ANDA075480 REMEDYREPACK INC. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 52125-349_48711ae4-b51a-5ac2-e054-00144ff8d46c 52125-349 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20121208 ANDA ANDA040901 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 52125-350_48713644-07d2-601e-e054-00144ff8d46c 52125-350 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20121208 ANDA ANDA040901 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 52125-352_5659bf67-6f55-51d8-e054-00144ff8d46c 52125-352 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121210 NDA AUTHORIZED GENERIC NDA018279 REMEDYREPACK INC. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 52125-353_48711ae4-b4b7-5ac2-e054-00144ff8d46c 52125-353 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20121211 ANDA ANDA073457 REMEDYREPACK INC. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 52125-358_486fc2c3-8195-1e58-e054-00144ff88e88 52125-358 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20121219 ANDA ANDA091630 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 52125-360_4836d8b5-cf6b-078b-e054-00144ff8d46c 52125-360 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20121219 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52125-367_4839727a-acfd-103d-e054-00144ff8d46c 52125-367 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20130103 UNAPPROVED DRUG OTHER REMEDYREPACK INC. PHENOBARBITAL 97.2 mg/1 CIV N 20181231 52125-411_476bf095-3b3e-152a-e054-00144ff8d46c 52125-411 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20130108 ANDA ANDA085828 REMEDYREPACK INC. SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 52125-423_5f0200c7-c62a-721a-e053-2a91aa0af5af 52125-423 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130116 ANDA ANDA090548 REMEDYREPACK INC. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 52125-431_476c44da-e6e5-2f71-e054-00144ff8d46c 52125-431 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130131 ANDA ANDA040103 REMEDYREPACK INC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 52125-438_36fc7dc3-535e-2182-e054-00144ff88e88 52125-438 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20130121 NDA NDA018851 REMEDYREPACK INC. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52125-452_476c8d8c-a551-5515-e054-00144ff88e88 52125-452 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20130124 ANDA ANDA090528 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 52125-459_3776bfe7-2e95-0aca-e054-00144ff88e88 52125-459 HUMAN PRESCRIPTION DRUG NASONEX Mometasone furoate monohydrate SPRAY, METERED NASAL 20140923 NDA NDA020762 REMEDYREPACK INC. MOMETASONE FUROATE MONOHYDRATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52125-460_565ac13f-3d1e-08e8-e054-00144ff8d46c 52125-460 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130207 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 52125-470_4d9ef14a-4825-4fcf-e054-00144ff8d46c 52125-470 HUMAN PRESCRIPTION DRUG LATANOPROST LATANOPROST SOLUTION/ DROPS OPHTHALMIC 20130131 ANDA ANDA090887 REMEDYREPACK INC. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 52125-494_476f8b2a-dd1c-3c98-e054-00144ff8d46c 52125-494 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 20130221 NDA NDA020895 REMEDYREPACK INC. SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 52125-501_3788e8b6-aba6-1513-e054-00144ff88e88 52125-501 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20130705 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 52125-555_476fbc97-a5df-5ac9-e054-00144ff8d46c 52125-555 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130304 ANDA ANDA085161 REMEDYREPACK INC. PREDNISONE 20 mg/1 N 20181231 52125-556_6301ab99-175e-144a-e053-2a91aa0adb77 52125-556 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130401 ANDA ANDA075932 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 52125-557_3cf67dba-0a82-59ea-e054-00144ff88e88 52125-557 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20130306 ANDA ANDA070184 REMEDYREPACK INC. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 52125-583_47944b26-42b7-71b6-e054-00144ff88e88 52125-583 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20130328 ANDA ANDA090937 REMEDYREPACK INC. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 52125-594_e11b91b2-91f9-4295-b872-3e024e2233ae 52125-594 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130813 NDA NDA021210 REMEDYREPACK INC. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 52125-597_47947a3c-1643-28d6-e054-00144ff8d46c 52125-597 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20130326 ANDA ANDA072575 REMEDYREPACK INC. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 52125-613_566c570e-263a-731b-e054-00144ff8d46c 52125-613 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20130409 NDA NDA021976 REMEDYREPACK INC. DARUNAVIR ETHANOLATE 800 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 52125-620_3d971bc4-4829-3d10-e054-00144ff88e88 52125-620 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20130415 ANDA ANDA091630 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 E 20171231 52125-644_405720c0-997e-1d6d-e054-00144ff8d46c 52125-644 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20130611 ANDA ANDA076341 REMEDYREPACK INC. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 52125-651_47958c21-9708-7384-e054-00144ff8d46c 52125-651 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride CAPSULE ORAL 20130626 ANDA ANDA040319 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 52125-659_47959b46-3010-7010-e054-00144ff8d46c 52125-659 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20130702 ANDA ANDA040734 REMEDYREPACK INC. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 52125-663_44e7bda9-050c-1afe-e054-00144ff8d46c 52125-663 HUMAN PRESCRIPTION DRUG Phisohex hexachlorophene EMULSION TOPICAL 20130705 NDA NDA006882 REMEDYREPACK INC. HEXACHLOROPHENE 30 mg/mL Antiseptic [EPC] E 20171231 52125-666_39e131f5-9d63-4627-e054-00144ff8d46c 52125-666 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 20130730 ANDA ANDA040317 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 52125-675_5b272410-1420-6fc3-e053-2a91aa0a9389 52125-675 HUMAN OTC DRUG Senna Plus Sennosides and Docusate Sodium TABLET ORAL 20130719 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 52125-678_47a6dcd2-41d5-217e-e054-00144ff8d46c 52125-678 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20130724 ANDA ANDA090622 REMEDYREPACK INC. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 52125-683_566ce6f5-575f-6593-e054-00144ff88e88 52125-683 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20130816 ANDA ANDA040756 REMEDYREPACK INC. FOLIC ACID 1 mg/1 N 20181231 52125-694_47a84c0f-e60e-6860-e054-00144ff8d46c 52125-694 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20130829 ANDA ANDA089586 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 52125-699_5205c631-5695-63d1-e054-00144ff88e88 52125-699 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 20130913 NDA AUTHORIZED GENERIC NDA050711 REMEDYREPACK INC. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 52125-718_566ce6f5-5778-6593-e054-00144ff88e88 52125-718 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130927 ANDA ANDA075828 REMEDYREPACK INC. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 52125-763_4d0da99f-16e1-1275-e054-00144ff88e88 52125-763 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20131031 ANDA ANDA091519 REMEDYREPACK INC. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 52125-771_58f16a00-3e17-29de-e053-2991aa0a59a0 52125-771 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20131101 ANDA ANDA040226 REMEDYREPACK INC. PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 52125-779_47acd5a1-d12a-5d63-e054-00144ff8d46c 52125-779 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20131112 ANDA ANDA040734 REMEDYREPACK INC. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 52125-786_60cc114f-f63e-60f6-e053-2a91aa0acd53 52125-786 HUMAN PRESCRIPTION DRUG Aplisol Tuberculin Purified Protein Derivative INJECTION INTRADERMAL 20131126 BLA BLA103782 REMEDYREPACK INC. TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU]/.1mL Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [Chemical/Ingredient] N 20181231 52125-793_47cd4a59-7070-6a6c-e054-00144ff8d46c 52125-793 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20131203 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52125-794_47ce956e-b577-4d9d-e054-00144ff88e88 52125-794 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20140904 ANDA ANDA074201 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52125-802_47cee089-b8bd-5b0a-e054-00144ff88e88 52125-802 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20131230 ANDA ANDA078069 REMEDYREPACK INC. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 52125-805_d37fbbc1-fe2a-490b-b01a-ead151f3e972 52125-805 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride trimethobenzamide hydrochloride INJECTION INTRAMUSCULAR 20140109 NDA AUTHORIZED GENERIC NDA017530 REMEDYREPACK INC. TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] E 20171231 52125-813_3a61bb31-bae1-68b9-e054-00144ff88e88 52125-813 HUMAN PRESCRIPTION DRUG VENTOLINHFA HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20141001 NDA NDA020983 REMEDYREPACK INC. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 52125-814_567fc67a-3db5-4916-e054-00144ff88e88 52125-814 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140115 ANDA ANDA078866 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 52125-816_36fca15b-d0df-4213-a2be-811d74714d49 52125-816 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20140130 ANDA ANDA202764 REMEDYREPACK INC. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 52125-840_56791fda-9929-6aa2-e054-00144ff88e88 52125-840 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170811 ANDA ANDA078787 REMEDYREPACK INC. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 52125-841_56791fda-995e-6aa2-e054-00144ff88e88 52125-841 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20170811 ANDA ANDA075828 REMEDYREPACK INC. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 52125-842_48acab64-af98-2570-e054-00144ff8d46c 52125-842 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140220 ANDA ANDA065169 REMEDYREPACK INC. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 52125-846_56810695-672b-5ec0-e054-00144ff88e88 52125-846 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20140226 ANDA ANDA077739 REMEDYREPACK INC. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 52125-850_47f839b9-ac8f-161c-e054-00144ff8d46c 52125-850 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20140303 ANDA ANDA086988 REMEDYREPACK INC. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 52125-851_567d2a98-502f-33c5-e054-00144ff8d46c 52125-851 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20170811 ANDA ANDA077206 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52125-859_3b502034-da89-73ab-e054-00144ff88e88 52125-859 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140306 ANDA ANDA077560 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 52125-862_567e9530-edb9-19f4-e054-00144ff8d46c 52125-862 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170811 ANDA ANDA078787 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 52125-864_57606e4b-80e9-6c60-e053-2a91aa0ab6b0 52125-864 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20140311 ANDA ANDA090170 REMEDYREPACK INC. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 52125-865_49c88164-0dea-529a-e054-00144ff8d46c 52125-865 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20140311 ANDA ANDA079098 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52125-868_49c96f16-8fb0-0abd-e054-00144ff8d46c 52125-868 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20140313 ANDA ANDA079098 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52125-877_5c5423be-088d-74ec-e053-2a91aa0abc87 52125-877 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20140320 ANDA ANDA077206 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52125-898_49cb9fa4-b1bc-0b86-e054-00144ff8d46c 52125-898 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20140414 ANDA ANDA079098 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52125-901_4822633a-5f45-469f-e054-00144ff88e88 52125-901 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140411 ANDA ANDA090617 REMEDYREPACK INC. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 52125-905_49da5655-28ae-09cf-e054-00144ff8d46c 52125-905 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20140414 ANDA ANDA078902 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52125-906_3ad10ed2-06c4-02a5-e054-00144ff88e88 52125-906 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20140415 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 52125-907_5179a651-8459-675c-e054-00144ff88e88 52125-907 HUMAN PRESCRIPTION DRUG PNV Prenatal Plus Multivitamin VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, and CUPRIC OXIDE TABLET ORAL 20140415 UNAPPROVED DRUG OTHER REMEDYREPACK INC. VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE 2000; 2000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 52125-909_3ace0af2-4f1f-4140-e054-00144ff8d46c 52125-909 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20140415 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 52125-910_3ac1e6bf-021f-503f-e054-00144ff8d46c 52125-910 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20140415 ANDA ANDA040663 REMEDYREPACK INC. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 52125-911_49da0659-f913-52b4-e054-00144ff88e88 52125-911 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20140417 ANDA ANDA079098 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52125-912_48206563-aba2-3847-e054-00144ff8d46c 52125-912 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 20140421 ANDA ANDA040254 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 52125-913_48209b78-13bf-09b6-e054-00144ff88e88 52125-913 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140418 ANDA ANDA077754 REMEDYREPACK INC. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 52125-915_5761d76b-7373-59fa-e053-2a91aa0aea53 52125-915 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 20140422 NDA AUTHORIZED GENERIC NDA020246 REMEDYREPACK INC. MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 52125-916_43be2779-94e3-4527-e054-00144ff8d46c 52125-916 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140424 ANDA ANDA090901 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 52125-922_3d6bd316-d614-3bbe-e054-00144ff8d46c 52125-922 HUMAN OTC DRUG Allergy Time Chlorpheniramine Maleate TABLET ORAL 20140429 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 52125-924_57629a1a-dee9-7ba7-e053-2991aa0aa76d 52125-924 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140428 ANDA ANDA090694 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52125-925_4833edcb-74a3-53c2-e054-00144ff88e88 52125-925 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140429 ANDA ANDA077560 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 52125-926_57622f12-93a2-b396-e053-2a91aa0ae520 52125-926 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL XL buPROPion hydrochloride TABLET, EXTENDED RELEASE ORAL 20140429 NDA NDA021515 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 52125-928_42669cda-154b-4181-e054-00144ff8d46c 52125-928 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20160816 ANDA ANDA090478 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 52125-931_48856a3e-1295-0959-e054-00144ff8d46c 52125-931 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20140507 ANDA ANDA077754 REMEDYREPACK INC. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 52125-937_48243c09-7402-022a-e054-00144ff8d46c 52125-937 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20140514 ANDA ANDA070278 REMEDYREPACK INC. HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] N 20181231 52125-939_57e78996-8d3f-47b8-e053-2991aa0a2469 52125-939 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20170829 ANDA ANDA090170 REMEDYREPACK INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 52125-942_57e76968-927a-6692-e053-2a91aa0a9f23 52125-942 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20170829 ANDA ANDA090695 REMEDYREPACK INC. LOXAPINE SUCCINATE 10 mg/1 N 20181231 52125-949_62eba1ab-2cd4-69d6-e053-2991aa0a05bd 52125-949 HUMAN PRESCRIPTION DRUG Atrovent ipratropium bromide SPRAY, METERED NASAL 20140528 NDA NDA020394 REMEDYREPACK INC. IPRATROPIUM BROMIDE 42 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 52125-950_4824ddee-3b3d-26b4-e054-00144ff8d46c 52125-950 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140527 ANDA ANDA077754 REMEDYREPACK INC. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 52125-956_4824ddee-3b05-26b4-e054-00144ff8d46c 52125-956 HUMAN PRESCRIPTION DRUG Abacavir Abacavir TABLET ORAL 20140606 ANDA ANDA091560 REMEDYREPACK INC. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 52125-958_4824ddee-3aba-26b4-e054-00144ff8d46c 52125-958 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20140603 ANDA ANDA077147 REMEDYREPACK INC. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 52125-959_53a75108-1807-00fe-e054-00144ff8d46c 52125-959 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20140604 ANDA ANDA075480 REMEDYREPACK INC. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 52125-961_5762f45f-ae6a-f98f-e053-2991aa0a1c81 52125-961 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140613 ANDA ANDA076255 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 52125-965_4836bab7-9384-01bf-e054-00144ff8d46c 52125-965 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20140613 ANDA ANDA075520 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 52125-974_3abcbdc3-b993-2c57-e054-00144ff8d46c 52125-974 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20140613 NDA NDA022122 REMEDYREPACK INC. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52125-975_5762f45f-aec6-f98f-e053-2991aa0a1c81 52125-975 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20140619 ANDA ANDA086183 REMEDYREPACK INC. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 52125-976_48363fb6-47a2-2ac7-e054-00144ff88e88 52125-976 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20140617 ANDA ANDA074979 REMEDYREPACK INC. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 52125-978_37eea1bd-4843-3844-e054-00144ff8d46c 52125-978 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20140625 ANDA ANDA091426 REMEDYREPACK INC. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 52125-980_57638aff-9172-fc9f-e053-2a91aa0a039c 52125-980 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20140703 ANDA ANDA071881 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 52125-988_57727985-d9c1-64b8-e053-2a91aa0a3411 52125-988 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20140714 NDA NDA018723 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 52125-998_494d7c00-0a1f-2985-e054-00144ff8d46c 52125-998 HUMAN PRESCRIPTION DRUG BioGlo Fluorescein Sodium STRIP OPHTHALMIC 20140804 UNAPPROVED DRUG OTHER REMEDYREPACK INC. FLUORESCEIN SODIUM 1 mg/mg Diagnostic Dye [EPC],Dyes [MoA] N 20181231 52125-999_36fe2822-0c4e-3cd4-e054-00144ff8d46c 52125-999 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20140804 ANDA ANDA074151 REMEDYREPACK INC. CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 52137-1001_e1219890-121d-49be-8014-2edb2ec241dd 52137-1001 HUMAN OTC DRUG THERAPY PAIN MENTHOL METHYL SALICYLATE CAPSAICIN GEL TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part348 Health Specialty.com MENTHOL; METHYL SALICYLATE; CAPSAICIN 10; 28; .025 g/100g; g/100g; g/100g N 20181231 52138-100_95c44325-705f-4014-a9fa-83de7a3df3c1 52138-100 HUMAN OTC DRUG CLEANpHIRST Alcohol Free Antiseptic Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20100512 OTC MONOGRAPH FINAL part333 Cleanphirst, LLC BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 52138-200_92b6dcf6-7786-4e83-8211-73ae66e723f9 52138-200 HUMAN OTC DRUG TD Take Down Alcohol Free Antiseptic Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20100331 OTC MONOGRAPH FINAL part333 Cleanphirst, LLC BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 52142-001_a03d1c34-feca-4325-a8a4-5543d89d5b6d 52142-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19900101 NDA NDA205865 Adirondack Compressed Gases, Inc OXYGEN 99 L/100L N 20181231 52146-1001_aab6ec68-7848-4a67-82dc-6f5b5636eb0f 52146-1001 HUMAN OTC DRUG Denpo cavity prevention fluoride TABLET, CHEWABLE ORAL 20100318 UNAPPROVED DRUG OTHER Suheung Capsule Co., Ltd SODIUM FLUORIDE 1.1 mg/1 E 20171231 52164-1101_3ecda643-f738-47fe-b2ce-8b05975d4569 52164-1101 HUMAN OTC DRUG ARC 42 Essential First Aid Items ISOPROPYL ALCOHOL KIT 20100429 OTC MONOGRAPH FINAL part345 American Red Cross N 20181231 52164-1102_d116b344-c454-4d0f-ad37-0d88301e7565 52164-1102 HUMAN OTC DRUG ARC FIRST AID Contains 101 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100429 OTC MONOGRAPH FINAL part333 American Red Cross N 20181231 52164-1103_b45576b9-c77e-4d28-ac35-44d5ee9982d5 52164-1103 HUMAN OTC DRUG ARC FIRST AID Contains 101 PIECES Hardcase BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100428 OTC MONOGRAPH FINAL part333 American Red Cross N 20181231 52164-1104_3bc2e75a-0863-40ce-8f64-7ec7d56aee19 52164-1104 HUMAN OTC DRUG ARC Emergency Preparedness FIRST AID Contains 202 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL, ASPIRIN KIT 20100427 OTC MONOGRAPH FINAL part333 American Red Cross N 20181231 52164-1105_11272c2b-c459-4cae-9248-4646a532e736 52164-1105 HUMAN OTC DRUG ARC FIRST AID Contains 303 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, ISOPROPYL ALCOHOL,BENZOCAINE,ALCOHOL, ASPIRIN,BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE KIT 20100429 OTC MONOGRAPH FINAL part333 American Red Cross N 20181231 52164-1106_badbeb85-1c35-4220-ae61-bf5052b41feb 52164-1106 HUMAN OTC DRUG ARC FIRST AID Contains 303 PIECES HARDCASE BENZALKONIUM CHLORIDE, LIDOCAINE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL,BENZOCAINE,ALCOHOL, ASPIRIN KIT 20100428 OTC MONOGRAPH FINAL part333 American Red Cross N 20181231 52164-1107_6abbad39-121a-4516-86f7-44bff245d21b 52164-1107 HUMAN OTC DRUG ARC FIRST AID Contains 404 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100427 OTC MONOGRAPH FINAL part333 American Red Cross N 20181231 52164-1108_50656ad8-a6ab-451b-90ff-dcce11587476 52164-1108 HUMAN OTC DRUG ARC FIRST AID Contains 1000 PIECES BENZALKONIUM CHLORIDE, LIDOCAINE, WATER, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN KIT 20100602 OTC MONOGRAPH FINAL part333 American Red Cross N 20181231 52164-1109_1d471d7f-c440-42c0-a013-ed9e2dd902f0 52164-1109 HUMAN OTC DRUG ARC FIRST AID Emergency Preparedness Contains 167 PIECES BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, WATER, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL, ASPIRIN, KIT 20100428 OTC MONOGRAPH FINAL part344 American Red Cross N 20181231 52164-1120_1ef38df7-8cb4-4909-9de8-edbb4675fa8d 52164-1120 HUMAN OTC DRUG The New Parent First Aid BACITRACIN ZINC,NEOMYCIN SULFATE,POLYMYXIN B SULFATE, ISOPROPYL ALCOHOL, ALCOHOL KIT 20100507 OTC MONOGRAPH FINAL part333 American Red Cross N 20181231 52166-001_8031ca13-2681-494e-a001-6b17afc29c01 52166-001 HUMAN OTC DRUG Argentyn 23 Argentum Metallicaum GEL TOPICAL 20090101 UNAPPROVED HOMEOPATHIC Natural Immunogenics Corp. SILVER 30 [hp_X]/1 N 20181231 52166-002_2504d7e6-7e5d-454a-8cc3-5b6f1ca4d9ad 52166-002 HUMAN OTC DRUG Sovereign Silver Argentum Metallicum GEL TOPICAL 20090101 UNAPPROVED HOMEOPATHIC Natural Immunogenics Corp. SILVER 30 [hp_X]/1 N 20181231 52174-001_800eb696-6938-4c2c-b748-93d9906145eb 52174-001 HUMAN OTC DRUG Kleen Instant Hand Sanitizer with Moisturizers ALCOHOL LIQUID TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 Ningbo Kleen Products Co., Ltd. ALCOHOL 62 g/100g E 20171231 52174-002_50016185-3b35-4112-870a-36545dc5c1d1 52174-002 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LIQUID TOPICAL 20100908 OTC MONOGRAPH NOT FINAL part333E Ningbo Kleen Products Co., Ltd. ALCOHOL 62 g/100g E 20171231 52183-088_2e79a844-0525-4788-af34-935b3dd04f9e 52183-088 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Blacksmith Brands Inc. CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 52183-101_00f2efb6-f353-4c70-8771-e34f1ac9b973 52183-101 HUMAN OTC DRUG Ludens Blue Raspberry Throat Drops Pectin LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 1.7 mg/1 N 20181231 52183-102_00f2efb6-f353-4c70-8771-e34f1ac9b973 52183-102 HUMAN OTC DRUG Ludens Watermelon Throat Drops Pectin LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 1.7 mg/1 N 20181231 52183-199_62f02822-6deb-4f13-817b-750c03d82a4b 52183-199 HUMAN OTC DRUG NasalCrom cromolyn sodium SPRAY, METERED NASAL 20091029 ANDA ANDA075702 Prestige Brands Holdings, Inc. CROMOLYN SODIUM 5.2 mg/1 N 20181231 52183-201_00f2efb6-f353-4c70-8771-e34f1ac9b973 52183-201 HUMAN OTC DRUG Ludens Blue Raspberry Throat Drops Pectin LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 N 20181231 52183-202_00f2efb6-f353-4c70-8771-e34f1ac9b973 52183-202 HUMAN OTC DRUG Ludens Watermelon Throat Drops Pectin LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 N 20181231 52183-203_19524644-c11b-4c16-96ed-407382a49d25 52183-203 HUMAN OTC DRUG Ludens Sugar Free Black Cherry Throat Pectin LOZENGE ORAL 20141201 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 N 20181231 52183-204_00f2efb6-f353-4c70-8771-e34f1ac9b973 52183-204 HUMAN OTC DRUG Ludens Green Apple Throat Drops Pectin LOZENGE ORAL 20150801 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 N 20181231 52183-208_00f2efb6-f353-4c70-8771-e34f1ac9b973 52183-208 HUMAN OTC DRUG Ludens Strawberry Banana Throat Drops Pectin LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 1.7 mg/1 N 20181231 52183-209_00f2efb6-f353-4c70-8771-e34f1ac9b973 52183-209 HUMAN OTC DRUG Ludens Strawberry Banana Throat Drops Pectin LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 N 20181231 52183-210_326cff6d-fc30-412d-8c07-608f7daaf267 52183-210 HUMAN OTC DRUG Ludens Red Hot Cinnamon pectin LOZENGE ORAL 20170401 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 N 20181231 52183-212_220c0e48-cfca-4a78-83da-5b75432ceed6 52183-212 HUMAN OTC DRUG Ludens Honey and Berry pectin LOZENGE ORAL 20170701 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 N 20181231 52183-229_00f2efb6-f353-4c70-8771-e34f1ac9b973 52183-229 HUMAN OTC DRUG Ludens Wild Cherry Throat Drops Pectin LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 N 20181231 52183-239_b5b745c2-610b-46e6-bb93-ab3a2aa20a38 52183-239 HUMAN OTC DRUG Ludens Wild Honey Throat Drops Pectin LOZENGE ORAL 20100708 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 N 20181231 52183-249_49903bcc-24f1-41ed-90ab-c4c247e1f876 52183-249 HUMAN OTC DRUG Ludens Sugar Free Wild Cherry Throat Pectin LOZENGE ORAL 20100712 OTC MONOGRAPH NOT FINAL part356 Blacksmith Brands, Inc. PECTIN 2.8 mg/1 N 20181231 52183-255_15bcc71f-1986-47e5-892a-3a64600e0a9e 52183-255 HUMAN OTC DRUG Ludens Honey Licorice Throat Drops Menthol LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. MENTHOL 1.6 mg/1 N 20181231 52183-259_15bcc71f-1986-47e5-892a-3a64600e0a9e 52183-259 HUMAN OTC DRUG Ludens Honey Licorice Throat Drops Menthol LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. MENTHOL 1 mg/1 N 20181231 52183-266_15bcc71f-1986-47e5-892a-3a64600e0a9e 52183-266 HUMAN OTC DRUG Ludens Honey Lemon Throat Drops Menthol LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. MENTHOL 1.6 mg/1 N 20181231 52183-269_15bcc71f-1986-47e5-892a-3a64600e0a9e 52183-269 HUMAN OTC DRUG Ludens Honey Lemon Throat Drops Menthol LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. MENTHOL 1 mg/1 N 20181231 52183-278_15bcc71f-1986-47e5-892a-3a64600e0a9e 52183-278 HUMAN OTC DRUG Ludens Menthol Throat Drops Menthol LOZENGE ORAL 20140204 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. MENTHOL 2.5 mg/1 N 20181231 52183-289_00f2efb6-f353-4c70-8771-e34f1ac9b973 52183-289 HUMAN OTC DRUG Ludens Berry Assortment Throat Drops Pectin LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 2.8 mg/1 N 20181231 52183-299_00f2efb6-f353-4c70-8771-e34f1ac9b973 52183-299 HUMAN OTC DRUG Ludens Wild Cherry Throat Drops Pectin LOZENGE ORAL 20091029 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PECTIN 1.7 mg/1 N 20181231 52183-385_18601d5b-086d-420d-a67e-04aa85367cfd 52183-385 HUMAN OTC DRUG PediaCare Childrens Plus Multisymptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCI LIQUID ORAL 20100709 20180228 OTC MONOGRAPH FINAL part341 Prestige Brands Holdings, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 52187-522_60a1c32b-70e4-332b-e053-2a91aa0a3fd8 52187-522 HUMAN PRESCRIPTION DRUG Salicylic Acid salicylic acid SOLUTION TOPICAL 20150601 UNAPPROVED DRUG OTHER KMM Pharmaceuticals, LLC SALICYLIC ACID 285 mg/mL N 20181231 52187-525_5c60df47-58d0-5226-e053-2a91aa0a1646 52187-525 HUMAN PRESCRIPTION DRUG XALIX SALICYLIC ACID SOLUTION TOPICAL 20171025 UNAPPROVED DRUG OTHER KMM Pharmaceuticals, LLC SALICYLIC ACID 280 mg/g N 20181231 52187-526_5df4c5b6-3ad3-7f2c-e053-2991aa0a021b 52187-526 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID LIQUID TOPICAL 20171114 UNAPPROVED DRUG OTHER KMM Pharmaceuticals, LLC SALICYLIC ACID 260 mg/mL N 20181231 52187-527_5df59b46-527b-53dc-e053-2991aa0a3fc2 52187-527 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID LIQUID TOPICAL 20171114 UNAPPROVED DRUG OTHER KMM Pharmaceuticals, LLC SALICYLIC ACID 275 mg/mL N 20181231 52187-528_5df38e39-a32b-8519-e053-2991aa0ad6c2 52187-528 HUMAN PRESCRIPTION DRUG Selenium Sulfide SELENIUM SULFIDE SHAMPOO TOPICAL 20171114 UNAPPROVED DRUG OTHER KMM Pharmaceuticals, LLC SELENIUM SULFIDE 22.5 mg/mL N 20181231 52188-515_8cfa64c8-f34e-480a-b86a-6d04b053c881 52188-515 HUMAN OTC DRUG Aftermath Hand Sanitizer HUSKY 515 GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 Aftermath Inc. ETHANOL 600 mL/1000mL E 20171231 52191-352_60c6f30a-84d6-5225-e053-2a91aa0adac0 52191-352 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate, Iodoquinol Hydrocortisone Acetate, Iodoquinol CREAM TOPICAL 20110729 UNAPPROVED DRUG OTHER Bowyn Labs, LLC HYDROCORTISONE ACETATE; IODOQUINOL 19; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52193-001_66b7ecd0-ba08-43b8-9850-32bb3cfa7f9a 52193-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100131 UNAPPROVED MEDICAL GAS Care Medical Oxygen and Home Supplies OXYGEN 99 L/100L E 20171231 52199-092_9d9cbc0a-6359-4a99-ac72-7f6e8221dbcd 52199-092 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET ORAL 20150427 ANDA ANDA091218 Shanghai Sine Pharmaceutical Laboratories Co., Ltd. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 52200-001_6b1bffe0-00bc-4273-bc09-d81155c31059 52200-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19810101 UNAPPROVED MEDICAL GAS Home Care Medical LLC OXYGEN 99 L/100L E 20171231 52204-103_495838f0-f2a7-465b-b5e0-4c57e23c86c8 52204-103 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, COATED ORAL 20110214 OTC MONOGRAPH FINAL part343 Cispharma, Inc ASPIRIN 81 mg/1 E 20171231 52204-111_8c174fea-0c59-4e24-baf0-e767f2dc572b 52204-111 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, COATED ORAL 20101115 OTC MONOGRAPH FINAL part343 Cispharma, Inc ASPIRIN 325 mg/1 E 20171231 52204-113_b33ff1bc-26be-4b1c-bcee-03a1c15015fd 52204-113 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20110328 OTC MONOGRAPH NOT FINAL part343 Cispharma, Inc ACETAMINOPHEN 325 mg/1 E 20171231 52204-114_d456e868-688a-4f9b-a7df-7c7087ab37ee 52204-114 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20110328 OTC MONOGRAPH NOT FINAL part343 Cispharma, Inc ACETAMINOPHEN 500 mg/1 E 20171231 52204-115_5db40826-6093-4adc-8f00-eeaffda69e7f 52204-115 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20110328 OTC MONOGRAPH NOT FINAL part343 Cispharma, Inc ACETAMINOPHEN 500 mg/1 E 20171231 52204-124_bbaaa8bb-d389-4ce2-ad82-d805ec281f72 52204-124 HUMAN OTC DRUG ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20110328 OTC MONOGRAPH NOT FINAL part343 Cispharma, Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 52205-001_2be512ee-2c1d-4860-ad8d-39f7117ee287 52205-001 HUMAN OTC DRUG Unagel SALICYLIC ACID CREAM TOPICAL 20120904 OTC MONOGRAPH FINAL part333D Advanced Skin Technology, LLC SALICYLIC ACID 2 g/100g E 20171231 52205-002_d5568a8b-650c-4811-983a-2867580aab6c 52205-002 HUMAN OTC DRUG Aqualant DIMETHICONE OIL TOPICAL 20120904 OTC MONOGRAPH FINAL part347 Advanced Skin Technology, LLC DIMETHICONE 24.92 mL/100mL E 20171231 52219-010_525e6897-f670-48d9-a468-22b08996e02a 52219-010 HUMAN OTC DRUG CYPRESS ESSENCE MASK PACK Witch Hazel PATCH TOPICAL 20120301 OTC MONOGRAPH FINAL part347 GREEN LIFE WITCH HAZEL .23 g/23mL E 20171231 52220-080_ba16c3eb-349d-4197-94de-ea41c8a04bde 52220-080 HUMAN OTC DRUG ARRAY Anitbacterial Foam Handwash Chloroxylenol LIQUID TOPICAL 20061130 OTC MONOGRAPH NOT FINAL part333E Gordon Food Service, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 52220-400_47e72cbe-d9d3-45b9-9210-1043b330bfd5 52220-400 HUMAN OTC DRUG ARRAY Plum Scent Antibacterial Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Gordon Food Service, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 52227-100_32f8722a-d964-4d1d-9be8-b62c686f83f0 52227-100 HUMAN OTC DRUG BAROX MENTHOL GEL TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 KTAIGA CO., LTD. MENTHOL 3 g/120mL E 20171231 52232-101_618fc7f8-21e3-fc7e-e053-2991aa0a827d 52232-101 HUMAN OTC DRUG Pro1Tek Antiseptic Hand Sanitizer BENZALKONIUM CHLORIDE AEROSOL, FOAM TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part333E Priority Environmental Solutions, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 52233-001_dd7dc678-c1f5-4c72-afd2-ad412e3258a3 52233-001 HUMAN PRESCRIPTION DRUG oxygen compressed oxygen GAS RESPIRATORY (INHALATION) 20100824 UNAPPROVED MEDICAL GAS Monroe Welding Supply, Inc. OXYGEN 992 mL/L E 20171231 52233-003_cc73270f-eccc-4966-bd2b-63c7ae4dbe22 52233-003 HUMAN PRESCRIPTION DRUG nitrogen compressed nitrogen GAS RESPIRATORY (INHALATION) 20100822 UNAPPROVED MEDICAL GAS Monroe Welding Supply, Inc. NITROGEN 992 mL/L E 20171231 52233-005_b1cbc715-bf35-44f7-91e4-3a186611fd51 52233-005 HUMAN PRESCRIPTION DRUG medical air compressed oxygen GAS RESPIRATORY (INHALATION) 20100822 UNAPPROVED MEDICAL GAS Monroe Welding Supply, Inc. OXYGEN; NITROGEN 210; 790 mL/L; mL/L E 20171231 52241-100_a8e9296f-a16b-46a3-90e0-407662540807 52241-100 HUMAN OTC DRUG Katinko Pain And Itch Relieving CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20100524 OTC MONOGRAPH NOT FINAL part348 Greenstone Pharmaceutical H.K. Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 11; 7.6; 13 g/100g; g/100g; g/100g N 20181231 52241-200_2ee5ef8e-4fe2-43af-a54a-61680f03669f 52241-200 HUMAN OTC DRUG Katinko Pain And Itch Relieving CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE OIL TOPICAL 20100524 OTC MONOGRAPH FINAL part348 Greenstone Pharmaceutical H.K. Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 11; 7.6; 13.5 g/100g; g/100g; g/100g N 20181231 52241-300_5741c85f-da5d-402e-888d-6daea61ad6cb 52241-300 HUMAN OTC DRUG Katinko Pain And Itch Relieving CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE STICK TOPICAL 20100524 OTC MONOGRAPH FINAL part348 Greenstone Pharmaceutical H.K. Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 11; 7.6; 13.5 g/100g; g/100g; g/100g N 20181231 52244-010_65b8eaa0-cb6d-471f-9c5e-a7ac31396414 52244-010 HUMAN PRESCRIPTION DRUG Edex alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20120415 NDA NDA020649 Actient Pharmaceuticals, LLC ALPROSTADIL 10 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 52244-020_65b8eaa0-cb6d-471f-9c5e-a7ac31396414 52244-020 HUMAN PRESCRIPTION DRUG Edex alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20120115 NDA NDA020649 Actient Pharmaceuticals, LLC ALPROSTADIL 20 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 52244-030_9c32da91-e09e-4fa2-a242-9d834ebe65a7 52244-030 HUMAN PRESCRIPTION DRUG Striant testosterone TABLET BUCCAL 20030619 NDA NDA021543 Endo Pharmaceuticals, Inc. TESTOSTERONE 30 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 52244-040_65b8eaa0-cb6d-471f-9c5e-a7ac31396414 52244-040 HUMAN PRESCRIPTION DRUG Edex alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20120315 NDA NDA020649 Actient Pharmaceuticals, LLC ALPROSTADIL 40 ug/mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 52244-100_3d3b5bb2-53fa-44bc-b3ce-321158492d00 52244-100 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 20140825 ANDA ANDA087942 Endo Pharmaceuticals, Inc. THEOPHYLLINE ANHYDROUS 100 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 52244-200_3d3b5bb2-53fa-44bc-b3ce-321158492d00 52244-200 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 20140825 ANDA ANDA087943 Endo Pharmaceuticals, Inc. THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 52244-300_3d3b5bb2-53fa-44bc-b3ce-321158492d00 52244-300 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 20140825 ANDA ANDA087944 Endo Pharmaceuticals, Inc. THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 52244-400_3d3b5bb2-53fa-44bc-b3ce-321158492d00 52244-400 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 20140825 ANDA ANDA081034 Endo Pharmaceuticals, Inc. THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 52244-404_84b92035-190d-4a3b-90de-12fba1c0bb4a 52244-404 HUMAN PRESCRIPTION DRUG SEMPREX D acrivastine and pseudoephedrine hydrochloride CAPSULE ORAL 20120126 NDA NDA019806 Actient Pharmaceuticals, LLC ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE 8; 60 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 52244-429_aa22a0f4-e704-494d-ac81-bb8508eeac84 52244-429 HUMAN PRESCRIPTION DRUG Robaxin Methocarbamol TABLET, FILM COATED ORAL 20120515 NDA NDA011011 Endo Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 52244-449_aa22a0f4-e704-494d-ac81-bb8508eeac84 52244-449 HUMAN PRESCRIPTION DRUG Robaxin Methocarbamol TABLET, FILM COATED ORAL 20110818 NDA NDA011011 Endo Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 52244-920_df80fad2-30ee-4de2-a81c-a5b7271a1cbe 52244-920 HUMAN PRESCRIPTION DRUG Dilatrate SR Isosorbide Dinitrate CAPSULE, EXTENDED RELEASE ORAL 20120215 NDA NDA019790 Endo Pharmaceuticals, Inc. ISOSORBIDE DINITRATE 40 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 52246-400_57db1455-57d1-4a3e-bc9a-633b122df362 52246-400 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE STRONTIUM esomeprazole strontium CAPSULE, DELAYED RELEASE ORAL 20161028 NDA NDA202342 ParaPRO LLC ESOMEPRAZOLE STRONTIUM 49.3 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 52246-929_964536c0-b87c-44c7-b119-40aae113ea5b 52246-929 HUMAN PRESCRIPTION DRUG Natroba spinosad SUSPENSION TOPICAL 20110125 NDA NDA022408 ParaPRO LLC SPINOSAD 9 mg/mL Pediculicide [EPC] N 20181231 52248-200_1f763999-d2c5-4eb9-94a3-22b655040e48 52248-200 HUMAN OTC DRUG Grandma Els Diaper Rash Ointment OINTMENT TOPICAL 20150201 OTC MONOGRAPH FINAL part347 MEADOWBROOK LABS, INC. PETROLATUM; LANOLIN .7595; .155 g/g; g/g E 20171231 52257-1001_edaef150-ae1a-4b6b-8058-a9b478cf6c20 52257-1001 HUMAN OTC DRUG ATOMY SUN CREAM SPF 50 PA OCTINOXATE CREAM TOPICAL 20100428 OTC MONOGRAPH NOT FINAL part352 ATOMY CO LTD OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 4.5; 3; 2.9; 1.5 mL/60mL; mL/60mL; mL/60mL; mL/60mL E 20171231 52257-1002_6a66799a-c889-4a45-aefc-f12dd55349d6 52257-1002 HUMAN OTC DRUG ATOMY BB CREAM SPF 30 PA OCTINOXATE CREAM TOPICAL 20100429 OTC MONOGRAPH NOT FINAL part352 ATOMY CO LTD OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.2; 3.2; .78 mL/40mL; mL/40mL; mL/40mL E 20171231 52257-1003_9d1738e0-b637-4c23-8935-86295173b1f8 52257-1003 HUMAN OTC DRUG ATOMY TOOTHPASTE SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20100525 OTC MONOGRAPH FINAL part355 ATOMY CO LTD SODIUM FLUORIDE; SODIUM MONOFLUOROPHOSPHATE .2; .32 g/200g; g/200g E 20171231 52257-1004_2ad667b8-581e-40da-9de8-331491c9f6f2 52257-1004 HUMAN OTC DRUG ATOMY HERBAL HAIR TONIC DEXPANTHENOL LIQUID TOPICAL 20100429 UNAPPROVED DRUG OTHER ATOMY CO LTD DEXPANTHENOL; LEVOMENTHOL; SALICYLIC ACID .4; .6; .5 mL/200mL; mL/200mL; mL/200mL E 20171231 52257-1100_a0c66b35-53ec-4bdd-98ce-75f2b74f59f1 52257-1100 HUMAN OTC DRUG Fresh Med Solution GLYCERIN, ALCOHOL, GLYCERYL MONOSTEARATE LIQUID TOPICAL 20110718 OTC MONOGRAPH FINAL part347 ATOMY CO LTD GLYCERIN; ALCOHOL; GLYCERYL MONOSTEARATE 1.744; 1.6; .4 mL/40mL; mL/40mL; mL/40mL N 20181231 52257-1110_6eca6fb4-d4e6-4dc4-95a8-8006cfdbef08 52257-1110 HUMAN OTC DRUG Calming Skin PANTHENOL, GLYCERIN, TOCOPHEROL LOTION TOPICAL 20110718 UNAPPROVED DRUG OTHER ATOMY CO LTD PANTHENOL; GLYCERIN; TOCOPHEROL .65; .65; .65 mL/130mL; mL/130mL; mL/130mL N 20181231 52257-1200_b0874195-4256-4436-817d-818b4d0ba1c3 52257-1200 HUMAN OTC DRUG ATOMY MINERAL PACT SPF35 PA PLUS PLUS NO.13 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20100429 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.2; .23 g/12g; g/12g N 20181231 52257-1201_568f0324-2bcd-4e4a-afcd-657937e00e6f 52257-1201 HUMAN OTC DRUG ATOMY MINERAL PACT SPF35 PA PLUS PLUS NO.21 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20100429 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.2; .23 g/12g; g/12g N 20181231 52257-1202_a1bfd1f4-4c95-4620-8664-4624de7b9d6b 52257-1202 HUMAN OTC DRUG ATOMY MINERAL PACT SPF35 PA PLUS PLUS NO.23 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20100429 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.2; .23 g/12g; g/12g N 20181231 52257-1203_e8661940-0ebf-4d78-b43b-a9d4e5fe8276 52257-1203 HUMAN OTC DRUG ATOMY SUN SPF50 PLUS PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20100428 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 4.5; 3; 2.88; 1.49 mL/60mL; mL/60mL; mL/60mL; mL/60mL N 20181231 52257-1204_9231064f-675b-4b73-9c4f-b1329bf81d3a 52257-1204 HUMAN OTC DRUG ATOMY SUN BEIGE SPF50 PLUS PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20100428 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 4.5; 3; 2.94; 1.49 mL/60mL; mL/60mL; mL/60mL; mL/60mL N 20181231 52257-1205_525b39df-b72b-4c85-9b5e-892740605659 52257-1205 HUMAN OTC DRUG ATOMY MINERAL PACT SPF35 PA PLUS PLUS NO.25 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20100429 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.2; .23 g/12g; g/12g N 20181231 52257-1206_682caafa-9c60-4b07-8058-3132c1724e2c 52257-1206 HUMAN OTC DRUG ATOMY BB SPF30 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20100429 OTC MONOGRAPH FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.168; 1.2; .768 mL/40mL; mL/40mL; mL/40mL N 20181231 52257-1208_a47b5a6d-b4fc-41b4-ba7a-df0b33cadc05 52257-1208 HUMAN OTC DRUG PROPOLIS 50g SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100525 OTC MONOGRAPH FINAL part355 ATOMY CO., LTD. SODIUM MONOFLUOROPHOSPHATE; SODIUM FLUORIDE .08; .05 g/50g; g/50g N 20181231 52257-1209_be3364e4-db4f-40bc-8f48-f65723ec9f98 52257-1209 HUMAN OTC DRUG PROPOLIS 200g SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20100525 OTC MONOGRAPH FINAL part355 ATOMY CO., LTD. SODIUM MONOFLUOROPHOSPHATE; SODIUM FLUORIDE .32; .2 g/200g; g/200g N 20181231 52257-1210_dbe504f6-c10f-4e78-bd96-ffadf7e4a12d 52257-1210 HUMAN OTC DRUG Atomy Sunscreen Beige SPF50 PLUS Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 4.08; 2.7; 8.06; 2.92 mg/60mL; mg/60mL; mg/60mL; mg/60mL N 20181231 52257-1220_70512bc8-79f3-4ac5-8218-171eb42a9ac3 52257-1220 HUMAN OTC DRUG Atomy Sunscreen White SPF50 PLUS Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 4.08; 2.7; 8.06; 2.92 mg/60mL; mg/60mL; mg/60mL; mg/60mL N 20181231 52257-1230_16d92eeb-d4a3-48db-bfef-7a5ee437719a 52257-1230 HUMAN OTC DRUG ATOMY SUNSCREEN BEIGE BROAD SPECTRUM SPF50 PLUS Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 4.08; 2.7; 8.06; 2.92 mg/60mL; mg/60mL; mg/60mL; mg/60mL N 20181231 52257-1240_ab820809-ea11-4457-b1f0-0b3840861f2a 52257-1240 HUMAN OTC DRUG ATOMY SUNSCREEN WHITE BROAD SPECTRUM SPF50 PLUS Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 4.08; 2.7; 8.06; 2.92 mg/60mL; mg/60mL; mg/60mL; mg/60mL N 20181231 52257-1250_325cda4a-7ec9-4421-a7fc-c996cc727768 52257-1250 HUMAN OTC DRUG ATOMY BB BROAD SPECTRUM SPF30 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.16; 1.4; .76 mg/40mL; mg/40mL; mg/40mL N 20181231 52257-1260_cc5e2f5d-182f-497d-8fd8-9edaa89969a5 52257-1260 HUMAN OTC DRUG ATOMY HAIR TREATMENT Panthenol, Menthol, Salicylic Acid LIQUID TOPICAL 20150201 UNAPPROVED DRUG OTHER ATOMY CO., LTD. PANTHENOL; MENTHOL; SALICYLIC ACID .4; .6; .38 mg/200mL; mg/200mL; mg/200mL N 20181231 52257-1270_1df7d8bb-0331-4aa9-803c-01b341257522 52257-1270 HUMAN OTC DRUG ATOMY MINERAL COMPACT NO.13 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.19; .23 g/12g; g/12g N 20181231 52257-1280_bf681667-351f-41d0-ac95-b5457cdf28ea 52257-1280 HUMAN OTC DRUG ATOMY MINERAL COMPACT NO.21 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.19; .23 g/12g; g/12g N 20181231 52257-1290_e6ae9ad6-e735-4337-b6b6-83463e7bb14f 52257-1290 HUMAN OTC DRUG ATOMY MINERAL COMPACT NO.23 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.19; .23 g/12g; g/12g N 20181231 52257-1300_c85981a6-8a43-4be8-b49b-5e730e2be93d 52257-1300 HUMAN OTC DRUG ATOMY MINERAL COMPACT NO.25 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.19; .23 g/12g; g/12g N 20181231 52257-1310_c6b5bd0d-d969-40b0-a7ac-650593f1530c 52257-1310 HUMAN OTC DRUG ATOMY PROPOLIS 50g Sodium Monofluorophosphate, Sodium Fluoride PASTE, DENTIFRICE ORAL 20150201 OTC MONOGRAPH FINAL part355 ATOMY CO., LTD. SODIUM MONOFLUOROPHOSPHATE; SODIUM FLUORIDE .08; .05 g/41; g/41 N 20181231 52257-1320_def92a47-0ac4-4d5f-9145-37e523025ffd 52257-1320 HUMAN OTC DRUG ATOMY PROPOLIS 200g Sodium Monofluorophosphate, Sodium Fluoride PASTE, DENTIFRICE ORAL 20150201 OTC MONOGRAPH FINAL part355 ATOMY CO., LTD. SODIUM MONOFLUOROPHOSPHATE; SODIUM FLUORIDE .32; .2 g/200g; g/200g N 20181231 52257-1330_468fca1b-b65a-4320-95fa-529d8650efbc 52257-1330 HUMAN OTC DRUG ATOMY BB Broad Spectrum Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.16; 1.4; .76 g/40mL; g/40mL; g/40mL N 20181231 52257-1340_6085d846-42f0-4ad7-ab1c-6c6e2c849b8b 52257-1340 HUMAN OTC DRUG ATOMY LIP GLOW OCTINOXATE, OCTISALATE GEL TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 ATOMY CO., LTD. OCTINOXATE; OCTISALATE .19; .09 g/3.3g; g/3.3g N 20181231 52257-1350_0863b8d7-55a2-4cc4-aa40-596625ca2124 52257-1350 HUMAN OTC DRUG ATOMY PROPOLIS TOOTHPAS TE 50g Sodium Monofluorophosphate, Sodium Fluoride PASTE, DENTIFRICE ORAL 20160801 OTC MONOGRAPH FINAL part355 ATOMY CO., LTD. SODIUM MONOFLUOROPHOSPHATE; SODIUM FLUORIDE .08; .05 g/50g; g/50g N 20181231 52257-1360_f6e5d024-9610-400a-afa6-a0e8d068f760 52257-1360 HUMAN OTC DRUG ATOMY PROPOLIS TOOTHPAS TE 200g Sodium Monofluorophosphate, Sodium Fluoride PASTE, DENTIFRICE ORAL 20160801 OTC MONOGRAPH FINAL part355 ATOMY CO., LTD. SODIUM MONOFLUOROPHOSPHATE; SODIUM FLUORIDE .32; .2 g/200g; g/200g N 20181231 52261-0100_9987f223-4261-43a1-99d0-9219140c8c8a 52261-0100 HUMAN OTC DRUG Forticept Antifungal Balm Tolmaftate LIQUID TOPICAL 20160504 OTC MONOGRAPH FINAL part333C Cosco International, Inc. TOLNAFTATE 10 g/1000g E 20171231 52261-0200_20d83e39-88d8-4aff-8a57-3c5a7eec438f 52261-0200 HUMAN OTC DRUG Fiore Rx Pink Peppermint Pie Antifungal Nail Polish Undecylenic Acid FILM TOPICAL 20130423 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL E 20171231 52261-0201_f73e80ce-e1f9-4833-97f7-695adfb68860 52261-0201 HUMAN OTC DRUG Fiore Rx Antifungal Nail Lacquer Red Velvet Cake Undecylenic Acid FILM TOPICAL 20130520 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL E 20171231 52261-0202_c16568f2-cf08-4224-80c3-6ecc10d05215 52261-0202 HUMAN OTC DRUG Fiore Rx Almond Milk Matte Antifungal Nail Lacquer Undecylenic Acid FILM TOPICAL 20130521 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL E 20171231 52261-0203_6e3bcae5-e6bf-4455-ae30-8237138a2cc5 52261-0203 HUMAN OTC DRUG Fiore Rx Rock Candy Clear Antifungal Nail Lacquer Undecylenic Acid FILM TOPICAL 20130521 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL E 20171231 52261-0204_e472d4a8-1150-4b38-a370-83f4c0fdf5d5 52261-0204 HUMAN OTC DRUG Fiore Rx Pixie Dust Pink Antifungal Nail Polish Undecylenic Acid FILM TOPICAL 20130521 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL E 20171231 52261-0205_d8465c59-fa95-4c05-96db-a2eae66dc39c 52261-0205 HUMAN OTC DRUG Fiore Rx Eggplant My Garden Antifungal Nail Polish Undecylenic Acid FILM TOPICAL 20130521 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL E 20171231 52261-0206_1c2ca992-c050-4ea6-a849-e5746b3e7eae 52261-0206 HUMAN OTC DRUG Fiore Rx CranApple Crush Antifungal Nail Polish Undecylenic Acid FILM TOPICAL 20130522 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL E 20171231 52261-0207_3c3e09f1-2aa8-4bf7-b4dc-8af16d0e3759 52261-0207 HUMAN OTC DRUG Fiore Rx Coral Sorbet Antifungal Nail Polish Undecylenic Acid FILM TOPICAL 20130522 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .45 g/15mL E 20171231 52261-0500_aa0aed5b-e329-4382-bae9-e797028dcc09 52261-0500 HUMAN OTC DRUG BerbereX Wound Cleanser Benzethonium Chloride LIQUID TOPICAL 20150517 OTC MONOGRAPH NOT FINAL part333A Cosco International, Inc. ALLANTOIN; BENZETHONIUM CHLORIDE 5; 1 g/1000mL; g/1000mL E 20171231 52261-0502_789f1b3c-89e2-4dff-86a0-ca51b0a0a661 52261-0502 HUMAN OTC DRUG Forticept Antifungal Cooling CLOTRIMAZOLE LIQUID TOPICAL 20160504 OTC MONOGRAPH FINAL part333C Cosco International, Inc. CLOTRIMAZOLE 10 g/1000g E 20171231 52261-0700_bed9313c-d763-4c02-8b00-92cd66bd393d 52261-0700 HUMAN OTC DRUG Forticept Antimicrobial Wound Cleanser Benzalkonium Chloride LIQUID TOPICAL 20161027 OTC MONOGRAPH NOT FINAL part333A Cosco International, Inc. BENZALKONIUM CHLORIDE 1.3 g/1000g E 20171231 52261-0701_93d1511d-c343-47be-8261-2632b4dd8dcb 52261-0701 HUMAN OTC DRUG Forticept Antimicrobial Gel Benzethonium Chloride GEL TOPICAL 20161027 OTC MONOGRAPH NOT FINAL part333A Cosco International, Inc. BENZETHONIUM CHLORIDE; THYMOL 1; 1 g/1000g; g/1000g E 20171231 52261-1500_c5bac75d-bd78-4833-8ad6-1165a72dd9a6 52261-1500 HUMAN OTC DRUG Smart Stuff Natural Lip Treatment SPF15 4g zinc oxide LIPSTICK TOPICAL 20160318 OTC MONOGRAPH FINAL part352 Cosco International, Inc. ZINC OXIDE .462 g/4.62g E 20171231 52261-2500_08c5d7fd-ce4a-43da-9972-127cef00fe89 52261-2500 HUMAN OTC DRUG Fiore Rx Antifungal ProPen Undecylenic Acid LIQUID TOPICAL 20130521 OTC MONOGRAPH FINAL part333C Cosco International, Inc. UNDECYLENIC ACID .5 g/2g E 20171231 52261-2501_62f5555c-0f35-4407-bc84-80d6e83c0d12 52261-2501 HUMAN OTC DRUG vbeaute Day Job 30ml zinc oxide LOTION TOPICAL 20130708 OTC MONOGRAPH FINAL part352 Cosco International, Inc. ZINC OXIDE 6.87 g/34.35g E 20171231 52261-2502_9201c0f6-3b97-4f57-8da0-e3aca28c1e84 52261-2502 HUMAN OTC DRUG Smart Stuff SPF30 4oz zinc oxide LOTION TOPICAL 20150604 OTC MONOGRAPH FINAL part352 Cosco International, Inc. ZINC OXIDE 23.7 g/118.294g E 20171231 52261-3700_b0bbc6c1-0b1a-4d17-ac8c-c7741a5d1322 52261-3700 HUMAN OTC DRUG Tiege Hanley Daily Moisturizer SPF20 octinoxate LOTION TOPICAL 20161115 OTC MONOGRAPH FINAL part352 Cosco International, Inc. OCTINOXATE; AVOBENZONE; OCTOCRYLENE .055; .025; .02 kg/kg; kg/kg; kg/kg E 20171231 52261-4700_2f385e8d-a683-41b0-a0c3-d41ea87f4331 52261-4700 HUMAN OTC DRUG Carpe Antiperspirant for Feet Aluminum Sesquichlorohydrate LOTION TOPICAL 20170925 OTC MONOGRAPH FINAL part350 Cosco International, Inc. ALUMINUM SESQUICHLOROHYDRATE .15048 kg/kg N 20181231 52261-4701_cd9df972-0ad5-483c-a8a2-19bcde9438ba 52261-4701 HUMAN OTC DRUG Carpe Antiperspirant for Hands Aluminum Sesquichlorohydrate LOTION TOPICAL 20170925 OTC MONOGRAPH FINAL part350 Cosco International, Inc. ALUMINUM SESQUICHLOROHYDRATE .15048 kg/kg N 20181231 52268-012_45bc0b79-de6f-4a83-850d-55116da0c05b 52268-012 HUMAN PRESCRIPTION DRUG SUPREP Bowel Prep sodium sulfate, potassium sulfate, magnesium sulfate SOLUTION, CONCENTRATE ORAL 20100805 NDA NDA022372 Braintree Laboratories, Inc. SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM 17.5; 3.13; 1.6 g/mL; g/mL; g/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 52268-100_062f0a59-731c-4c94-ae5c-620df9e6f7f2 52268-100 HUMAN PRESCRIPTION DRUG GoLYTELY Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride POWDER, FOR SOLUTION ORAL 19840713 NDA NDA019011 Braintree Laboratories, Inc. POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 236; 22.74; 6.74; 5.86; 2.97 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 52268-101_062f0a59-731c-4c94-ae5c-620df9e6f7f2 52268-101 HUMAN PRESCRIPTION DRUG GoLYTELY Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride POWDER, FOR SOLUTION ORAL 19840713 NDA NDA019011 Braintree Laboratories, Inc. POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 236; 22.74; 6.74; 5.86; 2.97 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 52268-400_f5c1fa80-77d3-445f-a748-663a86cee202 52268-400 HUMAN PRESCRIPTION DRUG NuLYTELY With Flavor Packs Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride KIT ORAL 20070417 NDA NDA019797 Braintree Laboratories, Inc. N 20181231 52268-700_062f0a59-731c-4c94-ae5c-620df9e6f7f2 52268-700 HUMAN PRESCRIPTION DRUG GoLYTELY Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride POWDER, FOR SOLUTION ORAL 19840713 NDA NDA019011 Braintree Laboratories, Inc. POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 227.1; 21.5; 6.36; 5.53; .754 g/L; g/L; g/L; g/L; g/L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 52270-001_ebccf5e2-7eeb-40d9-9491-7daf90e48d14 52270-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140401 UNAPPROVED MEDICAL GAS Grant County Medical Equipment, LLC OXYGEN 1 L/L E 20171231 52271-158_1f90ba87-1aa3-4099-996f-d0f8d0eb9193 52271-158 HUMAN OTC DRUG Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20090921 OTC MONOGRAPH FINAL part341 Quality Care Distributors LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 5.31; 1.13; 1.13 g/113g; g/113g; g/113g N 20181231 52271-159_83734ee7-58a7-401b-b921-fab10197227a 52271-159 HUMAN OTC DRUG Hot Ice Soothing Analgesic Camphor and Menthol GEL TOPICAL 20090921 OTC MONOGRAPH FINAL part341 Quality Care Distributors LLC MENTHOL; CAMPHOR (SYNTHETIC) 2.27; 1.14 g/227g; g/227g N 20181231 52272-001_79006243-df58-4108-a484-9bb594b9a527 52272-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830827 NDA NDA205849 Albright Welding Supply Co., Inc. OXYGEN 990 mL/L N 20181231 52276-312_5df22f8e-b0f6-4c96-e053-2a91aa0a3549 52276-312 HUMAN PRESCRIPTION DRUG Carbaglu Carglumic Acid TABLET ORAL 20100318 NDA NDA022562 Orphan Europe, SARL CARGLUMIC ACID 200 mg/1 Carbamoyl Phosphate Synthetase 1 Activator [EPC],Carbamoyl Phosphate Synthetase 1 Activators [MoA] N 20181231 52276-400_31a684d0-cd98-4e46-b43a-ccbd17c41559 52276-400 HUMAN PRESCRIPTION DRUG Cystadane betaine POWDER, FOR SOLUTION ORAL 19961025 NDA NDA020576 Orphan Europe SARL BETAINE 1 g/g Methylating Activity [MoA],Methylating Agent [EPC] N 20181231 52276-401_620f8168-323f-c23b-e053-2a91aa0a2760 52276-401 HUMAN PRESCRIPTION DRUG Cystadane betaine POWDER, FOR SOLUTION ORAL 20180108 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Orphan Europe SARL BETAINE 1 g/g Methylating Activity [MoA],Methylating Agent [EPC] N 20191231 52279-001_60cf0746-6a47-56d4-e053-2991aa0a59da 52279-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20021001 NDA NDA205767 Wesco Gas & Welding Supply, Inc. OXYGEN 992 mL/L N 20181231 52279-002_60cf629b-086e-4f4f-e053-2a91aa0a200a 52279-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20021001 NDA NDA205713 Wesco Gas & Welding Supply, Inc. NITROGEN 990 mL/L N 20181231 52295-200_03218486-9b19-4ac2-ae39-6205a82183bf 52295-200 HUMAN OTC DRUG SPECIFIC BEAUTY DAILY HYDRATING SPF 30 AVOBENZONE,OCTOCRYLENE,OCTINOXATE,OXYBENZONE,OCTISALATE LOTION TOPICAL 20110120 OTC MONOGRAPH NOT FINAL part352 Somabella Laboratories, LLC AVOBENZONE; OCTOCRYLENE; OCTINOXATE; OXYBENZONE; OCTISALATE 3; 2.4; 5; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 52295-207_1950041c-ed07-4ead-bbdf-7c4048efcfcf 52295-207 HUMAN OTC DRUG Specific Beauty Clarifying Wash Acne Treatment Cleanser SALICYLIC ACID SOAP TOPICAL 20110506 OTC MONOGRAPH FINAL part333D Somabella Laboratories, LLC SALICYLIC ACID 20 mg/mL E 20171231 52301-303_50d35250-36d5-24bf-e054-00144ff8d46c 52301-303 HUMAN OTC DRUG Formula 303 Valerian Root, Passiflora, Magnesium Carbonate TABLET ORAL 19900919 UNAPPROVED HOMEOPATHIC Dee Cee Laboratories PASSIFLORA INCARNATA FLOWER; MAGNESIUM CARBONATE; VALERIAN 3; 1; 6 [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X] N 20181231 52301-365_4aa767e7-6691-406a-9906-4b40ba27d8e2 52301-365 HUMAN OTC DRUG Kool Comfort Menthol GEL TOPICAL 20120705 OTC MONOGRAPH NOT FINAL part348 Dee Cee Laboratories, Inc. MENTHOL 2.5 g/100g E 20171231 52305-144_20a3714a-dfa1-4416-a5c7-46553401a6a5 52305-144 HUMAN OTC DRUG Trailways hand sanitizer Alcohol LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part341 Freshorize, Ltd. ALCOHOL 250 mL/295mL E 20171231 52305-200_99c19d09-7127-414c-891d-e864c840a1a7 52305-200 HUMAN OTC DRUG Freshorize hand sanitizer Alcohol LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part333A Freshorize, Ltd. ALCOHOL 185 mL/295mL E 20171231 52305-200_9ccaf1be-aacf-4d1b-a10d-a87498dfdf0d 52305-200 HUMAN OTC DRUG Freshorize hand sanitizer Alcohol LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part333A Freshorize, Ltd. ALCOHOL 185 mL/295mL E 20171231 52305-300_26655249-257e-4763-bee6-1dcddb692925 52305-300 HUMAN OTC DRUG Freshorize Alcohol Free foaming hand sanitizer Benzalkonium Chloride LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part333A Freshorize, Ltd. BENZALKONIUM CHLORIDE .364 g/280mL E 20171231 52305-400_bf032d5e-d855-4cf5-a3e5-c763d194e3e0 52305-400 HUMAN OTC DRUG Peter Pan Alcohol Free foaming hand sanitizer Benzalkonium Chloride LOTION TOPICAL 20110120 OTC MONOGRAPH NOT FINAL part333A Freshorize, Ltd. BENZALKONIUM CHLORIDE .364 g/280mL E 20171231 52316-028_8ecf77c1-f102-4992-a08e-6f3d42a6036b 52316-028 HUMAN OTC DRUG Vortex Toothpaste PASTE, DENTIFRICE DENTAL 20111230 OTC MONOGRAPH FINAL part355 DSC Laboratories, Div. of DSC Products Inc. SODIUM FLUORIDE 2 mg/g N 20181231 52316-720_5d8e59d4-dbe9-f680-e053-2991aa0a9060 52316-720 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20170801 OTC MONOGRAPH NOT FINAL part334 DSC Laboratories Inc. GLYCERIN 2 g/1 N 20181231 52316-723_5e97aa5b-62e3-0664-e053-2a91aa0ac341 52316-723 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20120815 OTC MONOGRAPH NOT FINAL part334 DSC Laboratories Inc. GLYCERIN 2.1 g/1 N 20181231 52316-724_5e97c4d2-e41e-5bb6-e053-2a91aa0a3163 52316-724 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20120815 OTC MONOGRAPH NOT FINAL part334 DSC Laboratories Inc. GLYCERIN 1.2 g/1 N 20181231 52318-002_60eff1e9-f41c-1fc4-e053-2991aa0abdf0 52318-002 HUMAN OTC DRUG JOURNEE OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part352 Neocutis, Inc. OCTINOXATE; ZINC OXIDE 75; 73 mg/mL; mg/mL N 20181231 52319-001_a4520022-5845-44a8-aa30-bab7729af0d0 52319-001 HUMAN OTC DRUG Sarene Soothing Skin Allantoin STICK TOPICAL 20100419 OTC MONOGRAPH FINAL part347 Beekley Corporation ALLANTOIN 5 mg/g E 20171231 52322-002_a2cae1ea-ed87-4990-979b-eb8e763f061b 52322-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19671015 UNAPPROVED MEDICAL GAS Evergreen Supply Inc OXYGEN 995 mL/L E 20171231 52327-011_050c6139-344c-47d4-e054-00144ff88e88 52327-011 HUMAN OTC DRUG EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20141020 OTC MONOGRAPH NOT FINAL part334 Aidapak Services, LLC DOCUSATE SODIUM 250 mg/250mg E 20171231 52342-001_3d289299-692d-44c7-aca0-eef7b0adf28e 52342-001 HUMAN OTC DRUG Anti Chafe Balm Allantoin STICK TOPICAL 20100701 OTC MONOGRAPH FINAL part347 Hickory Brands Inc. ALLANTOIN 5 mg/g E 20171231 52343-001_45d5d3f1-43e6-41e4-b2b4-51ba9085a526 52343-001 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Gen-Source Rx CEPHALEXIN 250 mg/1 E 20171231 52343-002_45d5d3f1-43e6-41e4-b2b4-51ba9085a526 52343-002 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Gen-Source Rx CEPHALEXIN 500 mg/1 E 20171231 52343-009_bd5b78b8-273c-4734-a352-aa325fb30052 52343-009 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 LUCID PHARMA LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 52343-010_bd5b78b8-273c-4734-a352-aa325fb30052 52343-010 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 LUCID PHARMA LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 52343-019_69e03c04-c878-446f-abdb-d8dec784a077 52343-019 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 Gen-Source Rx CEFPODOXIME PROXETIL 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52343-020_69e03c04-c878-446f-abdb-d8dec784a077 52343-020 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 Gen-Source Rx CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52343-021_9bbb0753-64db-4631-afb1-c39df6d563d9 52343-021 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 LUCID PHARMA LLC SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 52343-022_9bbb0753-64db-4631-afb1-c39df6d563d9 52343-022 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 LUCID PHARMA LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 52343-023_9bbb0753-64db-4631-afb1-c39df6d563d9 52343-023 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 LUCID PHARMA LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 52343-024_9bbb0753-64db-4631-afb1-c39df6d563d9 52343-024 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 LUCID PHARMA LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 52343-025_9bbb0753-64db-4631-afb1-c39df6d563d9 52343-025 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 LUCID PHARMA LLC SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 52343-026_ef23f388-64f8-4cc8-b2dc-c3cbb65f9c4a 52343-026 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 LUCID PHARMA LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 52343-027_ef23f388-64f8-4cc8-b2dc-c3cbb65f9c4a 52343-027 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 LUCID PHARMA LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 52343-028_ef23f388-64f8-4cc8-b2dc-c3cbb65f9c4a 52343-028 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 LUCID PHARMA LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 52343-029_ef23f388-64f8-4cc8-b2dc-c3cbb65f9c4a 52343-029 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 LUCID PHARMA LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 52343-030_c0ab8afc-0349-4d6f-8f0f-1a42e918c869 52343-030 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 LUCID PHARMA LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 52343-031_c0ab8afc-0349-4d6f-8f0f-1a42e918c869 52343-031 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 LUCID PHARMA LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 52343-032_c0ab8afc-0349-4d6f-8f0f-1a42e918c869 52343-032 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 LUCID PHARMA LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 52343-035_b3e84ee2-dd1d-474a-a51d-758f04010ed0 52343-035 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA202096 LUCID PHARMA LLC MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 52343-036_b3e84ee2-dd1d-474a-a51d-758f04010ed0 52343-036 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA202096 LUCID PHARMA LLC MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 52343-037_b3e84ee2-dd1d-474a-a51d-758f04010ed0 52343-037 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA202468 LUCID PHARMA LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 52343-038_5c962e8a-2f88-430e-9028-bc89276eff4c 52343-038 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140926 ANDA ANDA202050 LUCID PHARMA LLC OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 52343-039_5c962e8a-2f88-430e-9028-bc89276eff4c 52343-039 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140926 ANDA ANDA202050 LUCID PHARMA LLC OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 52343-040_5c962e8a-2f88-430e-9028-bc89276eff4c 52343-040 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140926 ANDA ANDA202050 LUCID PHARMA LLC OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 52343-041_5c962e8a-2f88-430e-9028-bc89276eff4c 52343-041 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140926 ANDA ANDA202050 LUCID PHARMA LLC OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 52343-042_5c962e8a-2f88-430e-9028-bc89276eff4c 52343-042 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140926 ANDA ANDA202050 LUCID PHARMA LLC OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 52343-043_5c962e8a-2f88-430e-9028-bc89276eff4c 52343-043 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20140926 ANDA ANDA202050 LUCID PHARMA LLC OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 52343-044_94250e7c-9fdd-4ac3-a2d9-e147f990c692 52343-044 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine CAPSULE ORAL 20060327 ANDA ANDA078128 LUCID PHARMA LLC ZIDOVUDINE 100 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 52343-045_65d4134d-7580-40d3-b561-d8a630c12138 52343-045 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20050919 ANDA ANDA077267 LUCID PHARMA LLC ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 52343-051_0409fcfe-2a26-4119-911a-ae7c654a80cd 52343-051 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 LUCID PHARMA LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 52343-052_0409fcfe-2a26-4119-911a-ae7c654a80cd 52343-052 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 LUCID PHARMA LLC VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 52343-053_d0ce0b84-ed29-45f1-a893-fd37cb7c450c 52343-053 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 LUCID PHARMA LLC PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 52343-054_d0ce0b84-ed29-45f1-a893-fd37cb7c450c 52343-054 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 LUCID PHARMA LLC PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 52343-055_d0ce0b84-ed29-45f1-a893-fd37cb7c450c 52343-055 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 LUCID PHARMA LLC PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 52343-059_434ccece-d924-4926-a268-ae565e711b61 52343-059 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 LUCID PHARMA LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 52343-060_434ccece-d924-4926-a268-ae565e711b61 52343-060 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 LUCID PHARMA LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 52343-061_434ccece-d924-4926-a268-ae565e711b61 52343-061 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 LUCID PHARMA LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 52343-062_a02c00d3-bdd5-4a80-bec3-dc828f4addda 52343-062 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20060329 ANDA ANDA065308 LUCID PHARMA LLC CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52343-063_a02c00d3-bdd5-4a80-bec3-dc828f4addda 52343-063 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20060329 ANDA ANDA065308 LUCID PHARMA LLC CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52343-069_14cea86a-d382-4b12-a857-0657237f6b6b 52343-069 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141106 ANDA ANDA078993 LUCID PHARMA LLC LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 52343-070_14cea86a-d382-4b12-a857-0657237f6b6b 52343-070 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141106 ANDA ANDA078993 LUCID PHARMA LLC LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 52343-071_14cea86a-d382-4b12-a857-0657237f6b6b 52343-071 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141106 ANDA ANDA078993 LUCID PHARMA LLC LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 52343-072_14cea86a-d382-4b12-a857-0657237f6b6b 52343-072 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141106 ANDA ANDA078993 LUCID PHARMA LLC LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 52343-073_5b54e4c1-0f96-4c83-9882-950072dfbba5 52343-073 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 LUCID PHARMA LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52343-074_5b54e4c1-0f96-4c83-9882-950072dfbba5 52343-074 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 LUCID PHARMA LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52343-075_5b54e4c1-0f96-4c83-9882-950072dfbba5 52343-075 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 LUCID PHARMA LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52343-076_5b54e4c1-0f96-4c83-9882-950072dfbba5 52343-076 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 LUCID PHARMA LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52343-085_5590e3fc-b9a1-4863-9420-900bf437a3cc 52343-085 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 LUCID PHARMA LLC FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 52343-086_5590e3fc-b9a1-4863-9420-900bf437a3cc 52343-086 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 LUCID PHARMA LLC FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 52343-087_5590e3fc-b9a1-4863-9420-900bf437a3cc 52343-087 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 LUCID PHARMA LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 52343-088_5590e3fc-b9a1-4863-9420-900bf437a3cc 52343-088 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 LUCID PHARMA LLC FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 52343-089_4b3cf469-8103-4efd-8fcf-8ec0f8707106 52343-089 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090056 LUCID PHARMA LLC DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 52343-090_4b3cf469-8103-4efd-8fcf-8ec0f8707106 52343-090 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090056 LUCID PHARMA LLC DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 52343-095_12adea11-6dfa-4ba4-aad0-66483bf79afb 52343-095 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150529 ANDA ANDA203974 LUCID PHARMA LLC METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 52343-096_12adea11-6dfa-4ba4-aad0-66483bf79afb 52343-096 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150529 ANDA ANDA203974 LUCID PHARMA LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 52343-116_1eb05aec-d955-4110-a522-412cfade8da8 52343-116 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 LUCID PHARMA LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 52343-117_1eb05aec-d955-4110-a522-412cfade8da8 52343-117 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 LUCID PHARMA LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 52343-118_1eb05aec-d955-4110-a522-412cfade8da8 52343-118 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 LUCID PHARMA LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 52343-119_b2134790-dfbd-416b-98aa-7886a14812ff 52343-119 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 LUCID PHARMA LLC LEVOFLOXACIN 250 mg/1 N 20181231 52343-120_b2134790-dfbd-416b-98aa-7886a14812ff 52343-120 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 LUCID PHARMA LLC LEVOFLOXACIN 500 mg/1 N 20181231 52343-121_b2134790-dfbd-416b-98aa-7886a14812ff 52343-121 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 LUCID PHARMA LLC LEVOFLOXACIN 750 mg/1 N 20181231 52343-122_15fadb4c-beb1-4e37-b8f5-8c2da5e1211b 52343-122 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA202223 LUCID PHARMA LLC VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 52343-123_15fadb4c-beb1-4e37-b8f5-8c2da5e1211b 52343-123 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA202223 LUCID PHARMA LLC VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 52343-124_15fadb4c-beb1-4e37-b8f5-8c2da5e1211b 52343-124 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA202223 LUCID PHARMA LLC VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 52343-125_15fadb4c-beb1-4e37-b8f5-8c2da5e1211b 52343-125 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA202223 LUCID PHARMA LLC VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 52343-131_6c7c6190-b35f-4228-ba3d-2cb3149c81b3 52343-131 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA200834 LUCID PHARMA LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52343-132_6c7c6190-b35f-4228-ba3d-2cb3149c81b3 52343-132 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA200834 LUCID PHARMA LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52343-133_6c7c6190-b35f-4228-ba3d-2cb3149c81b3 52343-133 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111123 ANDA ANDA200834 LUCID PHARMA LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52343-137_f1eca4f3-47d4-4cfa-9aed-27b535281e14 52343-137 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20150828 ANDA ANDA204310 LUCID PHARMA LLC RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 52343-147_1e7d88ab-1c57-4f5c-8100-7e271cdb22f2 52343-147 HUMAN PRESCRIPTION DRUG ENTECAVIR ENTECAVIR TABLET ORAL 20170206 ANDA ANDA206217 LUCID PHARMA LLC ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 52343-148_1e7d88ab-1c57-4f5c-8100-7e271cdb22f2 52343-148 HUMAN PRESCRIPTION DRUG ENTECAVIR ENTECAVIR TABLET ORAL 20170206 ANDA ANDA206217 LUCID PHARMA LLC ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 52343-151_b433f195-58fb-4818-8ef9-2b1c73d7fdba 52343-151 HUMAN PRESCRIPTION DRUG ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET ORAL 20170202 ANDA ANDA079170 LUCID PHARMA LLC ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 52343-152_b433f195-58fb-4818-8ef9-2b1c73d7fdba 52343-152 HUMAN PRESCRIPTION DRUG ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET ORAL 20170202 ANDA ANDA079170 LUCID PHARMA LLC ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 52343-153_b433f195-58fb-4818-8ef9-2b1c73d7fdba 52343-153 HUMAN PRESCRIPTION DRUG ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET ORAL 20170202 ANDA ANDA079170 LUCID PHARMA LLC ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 52343-154_b433f195-58fb-4818-8ef9-2b1c73d7fdba 52343-154 HUMAN PRESCRIPTION DRUG ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET ORAL 20170202 ANDA ANDA079170 LUCID PHARMA LLC ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 52343-160_7a72e13a-33b1-48f2-b036-7e08cb7b65ff 52343-160 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171127 ANDA ANDA202424 ACETRIS HEALTH, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 52343-161_7a72e13a-33b1-48f2-b036-7e08cb7b65ff 52343-161 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171127 ANDA ANDA202424 ACETRIS HEALTH, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 52343-162_7a72e13a-33b1-48f2-b036-7e08cb7b65ff 52343-162 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171127 ANDA ANDA202424 ACETRIS HEALTH, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 52343-163_7a72e13a-33b1-48f2-b036-7e08cb7b65ff 52343-163 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171127 ANDA ANDA202424 ACETRIS HEALTH, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 52343-164_7a72e13a-33b1-48f2-b036-7e08cb7b65ff 52343-164 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171127 ANDA ANDA202424 ACETRIS HEALTH, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 52343-165_7a72e13a-33b1-48f2-b036-7e08cb7b65ff 52343-165 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171127 ANDA ANDA202424 ACETRIS HEALTH, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 52343-166_7a72e13a-33b1-48f2-b036-7e08cb7b65ff 52343-166 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171127 ANDA ANDA202424 ACETRIS HEALTH, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 52345-1001_5a571a00-50c0-4ce1-aca2-8e65d1046217 52345-1001 HUMAN OTC DRUG Dream Eye POLOXAMER 407 LIQUID OPHTHALMIC 20100617 UNAPPROVED DRUG OTHER K&J.C Co., Ltd POLOXAMER 407 .1 mL/mL E 20171231 52345-2001_be14dd56-b21f-49ab-83e9-b3c1792422bf 52345-2001 HUMAN OTC DRUG Natural Care POLOXAMER 407 LIQUID OPHTHALMIC 20101005 UNAPPROVED DRUG OTHER K&J.C Co., Ltd POLOXAMER 407 .1 mL/mL E 20171231 52345-3001_afdb9a19-6514-4467-b2b9-ff809dc565e7 52345-3001 HUMAN OTC DRUG Dream Eye POLOXAMER 407 LIQUID OPHTHALMIC 20101013 UNAPPROVED DRUG OTHER K&J.C Co., Ltd POLOXAMER 407 .1 mL/mL E 20171231 52345-5001_a8526bd5-cba9-474e-8d43-e1fd74145911 52345-5001 HUMAN OTC DRUG NoSno XANTHAN GUM LIQUID NASAL 20120303 UNAPPROVED DRUG OTHER K&J.C Co., Ltd XANTHAN GUM .05 mL/44mL E 20171231 52346-011_49446352-7bc7-4646-9e57-403e92feea57 52346-011 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19851201 NDA NDA205866 Scott-Gross Company, Inc. NITROGEN 990 mL/L N 20181231 52346-012_60b7ccff-0338-0b76-e053-2991aa0ab117 52346-012 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19741201 NDA NDA206009 Scott-Gross Company, Inc. NITROUS OXIDE 990 mL/L N 20181231 52346-013_d78edcb8-7e98-43f7-b1bf-7335dfd10df2 52346-013 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19771201 NDA NDA205865 Scott-Gross Company, Inc. OXYGEN 990 mL/L N 20181231 52346-014_f46b4b6b-cc01-4b7c-813f-178aebd34d17 52346-014 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20061101 NDA NDA205821 Scott-Gross Company, Inc. AIR 1000 mL/L N 20181231 52346-015_cdc92405-ef69-40d7-840a-48718520548c 52346-015 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20131017 NDA NDA205846 Scott-Gross Company, Inc. CARBON DIOXIDE 900 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 52347-111_4d08bcae-5846-41a6-8136-651da8e1c582 52347-111 HUMAN OTC DRUG Skin Care Prescription Avobenzone,Octocrylene,Oxybenzone,Homosalate,Octisalate LOTION TOPICAL 20100623 OTC MONOGRAPH FINAL part352 Skin Care Physicians, Inc. AVOBENZONE; HOMOSALATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE 3.4; 17.01; .06; .05; 4.54 g/114.4g; g/113.4g; g/113.4g; g/113.4g; g/113.4g E 20171231 52358-0001_5e842bca-9eaa-f629-e053-2991aa0aaf61 52358-0001 HUMAN OTC DRUG Baby Butz Zinc Oxide CREAM TOPICAL 20130715 OTC MONOGRAPH FINAL part347 Olen Cosmetics Corporation ZINC OXIDE 17.1 g/57g N 20181231 52358-0002_5e8463fc-5727-ca64-e053-2a91aa0a3a69 52358-0002 HUMAN OTC DRUG SUPRADERM white petrolatum, lanolin CREAM TOPICAL 20141017 OTC MONOGRAPH FINAL part347 Olen Cosmetics Corporation PETROLATUM; LANOLIN .3; .15 g/g; g/g N 20181231 52358-0003_5e84042d-69d8-5069-e053-2a91aa0a6a25 52358-0003 HUMAN OTC DRUG Sunblocz Baby and Kids Zinc oxide CREAM TOPICAL 20160621 OTC MONOGRAPH NOT FINAL part352 Olen Cosmetics Corporation ZINC OXIDE 28.9 g/118mL N 20181231 52358-0004_5e843bd2-2eb8-9da3-e053-2a91aa0ad2a6 52358-0004 HUMAN OTC DRUG Sunblocz Zinc oxide CREAM TOPICAL 20160621 OTC MONOGRAPH NOT FINAL part352 Olen Cosmetics Corporation ZINC OXIDE 43.4 g/177mL N 20181231 52374-001_dad19bf8-07d0-435a-b933-2c961a9ea9fa 52374-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19901119 UNAPPROVED MEDICAL GAS Linde Gas Puerto Rico, Inc OXYGEN 99 L/100L N 20181231 52374-002_41a96f3a-9cd0-4757-9dae-0cf738b7537c 52374-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19901127 UNAPPROVED MEDICAL GAS Linde Gas Puerto Rico, Inc NITROGEN 99 L/100L N 20181231 52374-011_5f7d498d-45bc-4369-a5a5-370aa94006d3 52374-011 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205818 Linde Gas Puerto Rico, Inc OXYGEN 995 mL/L N 20181231 52374-016_8bc66511-0161-4cc3-be90-63f9a3b16a66 52374-016 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205816 Linde Gas Puerto Rico, Inc NITROGEN 995 mL/L N 20181231 52374-101_5a176648-8ffd-46ab-8f00-2094e0d74e78 52374-101 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860616 UNAPPROVED MEDICAL GAS Linde Gas Puerto Rico, Inc OXYGEN 99 L/100L N 20181231 52374-102_29cac53d-a92f-41ab-96ef-32e893ccf979 52374-102 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19860801 UNAPPROVED MEDICAL GAS Linde Gas Puerto Rico, Inc NITROGEN 99 L/100L N 20181231 52376-021_5f395fe0-2482-9442-e053-2a91aa0a9ebb 52376-021 HUMAN PRESCRIPTION DRUG PAROEX chlorhexidine gluconate RINSE ORAL 20060415 ANDA ANDA076434 Sunstar Americas, Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 52376-035_793f88ca-38a4-4aa0-bc2e-974f35e16b04 52376-035 HUMAN OTC DRUG Crayola SQUEEZE-A-COLOR Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130703 OTC MONOGRAPH FINAL part355 Sunstar Americas, Inc. SODIUM FLUORIDE .24 mg/g N 20181231 52376-036_bf287eab-3685-4e35-8568-a32bc18370ea 52376-036 HUMAN OTC DRUG Gum Sodium Fluoride PASTE, DENTIFRICE DENTAL 20131201 OTC MONOGRAPH FINAL part355 Sunstar Americas, Inc. SODIUM FLUORIDE .24 g/100g E 20171231 52376-040_b13b5c2d-f843-4182-a6af-0ffa7fbb73c4 52376-040 HUMAN OTC DRUG Equitance Sunscreen Broad Spectrum SPF 36 Octinoxate Zinc Oxide LOTION TOPICAL 20160412 OTC MONOGRAPH FINAL part352 Sunstar Americas, Inc OCTINOXATE; ZINC OXIDE 6.5; 16.88 g/100mL; g/100mL E 20171231 52376-043_a17f4915-ae90-4f01-8968-5cb713b2b35d 52376-043 HUMAN OTC DRUG Power-Rangers DINO CHARGE Sodium Fluoride PASTE, DENTIFRICE DENTAL 20151130 OTC MONOGRAPH FINAL part355 Sunstar Americas, Inc. SODIUM FLUORIDE .24 mg/g N 20181231 52376-044_952a3c55-f737-4c3e-9a91-67b732a3332b 52376-044 HUMAN OTC DRUG Crayola SQUEEZE-A-COLOR Sodium Fluoride PASTE, DENTIFRICE DENTAL 20151130 OTC MONOGRAPH FINAL part355 Sunstar Americas, Inc. SODIUM FLUORIDE .24 mg/g N 20181231 52380-0001_2927b827-1fd4-412c-e054-00144ff88e88 52380-0001 HUMAN OTC DRUG Aplicare Povidone-Iodine POVIDONE-IODINE SOLUTION TOPICAL 19840301 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52380-0005_32e54b08-576d-478e-8324-084247124d1b 52380-0005 HUMAN OTC DRUG Aplicare Isopropyl Alcohol Isopropyl Alcohol SOLUTION TOPICAL 19850101 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 52380-0011_3fca0005-f69c-48a2-8366-8ae177c45d34 52380-0011 HUMAN OTC DRUG Aplicare Povidone-Iodine POVIDONE-IODINE SOLUTION TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 52380-0013_58120b6c-7e5b-49ff-9e26-a912357366d1 52380-0013 HUMAN OTC DRUG Aplicare Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 19831201 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. HYDROGEN PEROXIDE 3 mL/100mL E 20171231 52380-0024_1285da93-6c8a-2841-e054-00144ff8d46c 52380-0024 HUMAN OTC DRUG Aplicare Povidone-Iodine Scrub Povidone-iodine Scrub SOLUTION TOPICAL 19920701 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52380-0025_dc616e0d-2478-41ed-b70c-3250039352b4 52380-0025 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL 19840101 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 8.1 g/100g E 20171231 52380-0026_29289182-903b-0968-e054-00144ff8d46c 52380-0026 HUMAN OTC DRUG Aplicare Povidone-Iodine Povidone-Iodine OINTMENT TOPICAL 19840701 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/g E 20171231 52380-0038_1288c4ed-3edf-2be7-e054-00144ff88e88 52380-0038 HUMAN OTC DRUG Aplicare Povidone Iodine Swabstick Povidone Iodine SOLUTION TOPICAL 20030601 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52380-0039_128991a4-5bc5-40b6-e054-00144ff88e88 52380-0039 HUMAN OTC DRUG Aplicare ExCel AP Povidone-Iodine and isopropyl alcohol SOLUTION TOPICAL 20040601 OTC MONOGRAPH NOT FINAL part333A Aplicare POVIDONE-IODINE; ISOPROPYL ALCOHOL 7.5; 720 mg/mL; mg/mL E 20171231 52380-0101_1284de4c-b79c-36f7-e054-00144ff88e88 52380-0101 HUMAN OTC DRUG Aplicare Povidone-Iodine Paint Povidone-Iodine SOLUTION TOPICAL 19920301 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52380-0111_293eed23-42dc-4524-e054-00144ff88e88 52380-0111 HUMAN OTC DRUG Aplicare Povidone-Iodine Prep Pad POVIDONE-IODINE SOLUTION TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/10mg E 20171231 52380-0124_20c91a42-f328-45b6-9f04-361fec63cf07 52380-0124 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Large Wing Sponge Povidone-iodine Scrub SOLUTION TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 52380-0125_9ade4db4-4292-4fed-adb2-b2057c1cb640 52380-0125 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 7.5 mg/mL N 20181231 52380-0126_78b1cb88-0d2b-45b2-a7e9-e05a99537070 52380-0126 HUMAN OTC DRUG Aplicare Povidone-Iodine Povidone-Iodine OINTMENT TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/g N 20181231 52380-0540_fcd4aef5-70b8-4889-ac0a-33977221c061 52380-0540 HUMAN OTC DRUG Aplicare Antiseptic Hand Rinse Ethanol GEL TOPICAL 20060801 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. ALCOHOL .62 mL/mL E 20171231 52380-0972_2449909a-0c4f-2168-e054-00144ff88e88 52380-0972 HUMAN OTC DRUG Clorox Healthcare Nasal Antiseptic Swabs Povidone Iodine swabstick SOLUTION TOPICAL 20151108 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52380-1101_267f52fa-a3df-3af8-e054-00144ff88e88 52380-1101 HUMAN OTC DRUG Aplicare Povidone Iodine Swabstick POVIDONE-IODINE SOLUTION TOPICAL 19840101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52380-1102_12c50917-6b02-3a62-e054-00144ff8d46c 52380-1102 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL 19840101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 7.5 mg/mL E 20171231 52380-1272_1d107814-357c-68e4-e054-00144ff88e88 52380-1272 HUMAN OTC DRUG Aplicare Antiseptic Chlorhexidine Gluconate Chlorhexidine Gluconate SOLUTION TOPICAL 19980901 NDA NDA019125 Aplicare, Inc. CHLORHEXIDINE GLUCONATE 4 g/100mL N 20191231 52380-1274_f9bac287-2fea-404f-96e7-1c3dd8b8aac3 52380-1274 HUMAN OTC DRUG Aplicare Antiseptic Chlorhexidine Gluconate Chlorhexidine Gluconate SOLUTION TOPICAL 19980901 NDA NDA019422 Aplicare, Inc. CHLORHEXIDINE GLUCONATE 2 g/100g E 20171231 52380-1614_3f02bcb8-cd7a-40fc-8bcf-492302cb1fea 52380-1614 HUMAN OTC DRUG Aplicare Antiseptic Hand Rinse Ethanol GEL TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. ALCOHOL 62 mL/100mL E 20171231 52380-1617_c3e5f62f-6fe8-42eb-862b-de0536c30570 52380-1617 HUMAN OTC DRUG Aplicare Antiseptic Perineal Wash II Benzethonium Chloride SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. BENZETHONIUM CHLORIDE .2 1/100g E 20171231 52380-1721_12d3cb6f-4a77-33b0-e054-00144ff88e88 52380-1721 HUMAN OTC DRUG Aplicare Povidone-iodine Povidone-iodine SOLUTION TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52380-1730_6780f5fe-51e5-4637-b049-389f557aadb9 52380-1730 HUMAN OTC DRUG Aplicare Povidone-iodine Povidone-iodine DOUCHE VAGINAL 19980901 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 10 g/100g E 20171231 52380-1738_12d4c92b-3451-509b-e054-00144ff88e88 52380-1738 HUMAN OTC DRUG Aplicare Povidone Iodine Povidone Iodine GEL TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52380-1771_24dd38b6-9e89-4527-8702-d1d4fe81ed23 52380-1771 HUMAN OTC DRUG Aplicare Isopropyl Alcohol Isopropyl Alcohol GEL TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 52380-1845_76291767-ebfd-42aa-8316-8edc7c0f479c 52380-1845 HUMAN OTC DRUG Aplicare Physicians Antibacterial Triclosan LIQUID TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. TRICLOSAN .3 g/100g E 20171231 52380-1855_147b39ed-2d94-665b-e054-00144ff8d46c 52380-1855 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 7.5 mg/mL E 20171231 52380-1865_f09a3365-8cd6-4daf-9033-b5e6963e0d9e 52380-1865 HUMAN OTC DRUG Antibacterial Lotion Soap Triclosan LIQUID TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. TRICLOSAN .3 g/100g E 20171231 52380-1880_580116d0-1677-4fcd-a188-cac8f00c1996 52380-1880 HUMAN OTC DRUG Aplicare Povidone-iodine Perineal Wash Povidone-iodine Perineal Wash LIQUID TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333 Aplicare, Inc. POVIDONE-IODINE 10 1/100g E 20171231 52380-1905_12d73c59-e896-21da-e054-00144ff88e88 52380-1905 HUMAN OTC DRUG Aplicare Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52380-1919_1d1f5e14-1060-2450-e054-00144ff88e88 52380-1919 HUMAN OTC DRUG Aplicare Chlorhexidine Gluconate 2% Solution Chlorhexidine Gluconate SOLUTION TOPICAL 19980901 NDA NDA019422 Aplicare, Inc. CHLORHEXIDINE GLUCONATE 2 g/100mL N 20181231 52380-1986_1843c021-65a2-5a0c-e054-00144ff8d46c 52380-1986 HUMAN OTC DRUG Aplicare Antiseptic Chlorhexidine Gluconate Chlorhexidine Gluconate SOLUTION TOPICAL 19980901 NDA NDA019125 Aplicare, Inc. CHLORHEXIDINE GLUCONATE 4 g/100mL N 20181231 52380-1987_1843c021-6567-5a0c-e054-00144ff8d46c 52380-1987 HUMAN OTC DRUG Aplicare Antiseptic Chlorhexidine Gluconate Chlorhexidine Gluconate SOLUTION TOPICAL 19980901 NDA NDA019125 Aplicare, Inc. CHLORHEXIDINE GLUCONATE 4 g/100mL N 20181231 52380-2801_12d82156-b597-2165-e054-00144ff8d46c 52380-2801 HUMAN OTC DRUG Aplicare Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52380-2802_133d34d7-8502-5a99-e054-00144ff8d46c 52380-2802 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 7.5 mg/mL E 20171231 52380-3101_291492fb-2d91-372f-e054-00144ff88e88 52380-3101 HUMAN OTC DRUG Aplicare Povidone-iodine Triples Povidone-iodine SOLUTION TOPICAL 19980301 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52380-3102_12c4355d-5ad3-2ed2-e054-00144ff88e88 52380-3102 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL 19840101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 7.5 mg/mL E 20171231 52380-3191_d314c1ac-8b7a-4978-9c4c-936ddb17a84e 52380-3191 HUMAN OTC DRUG Curity Povidone-Iodine Paint Povidone-Iodine SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 9.5 g/mL E 20171231 52380-4011_8f2375fd-e829-4ee3-b70d-2ad577cd6da0 52380-4011 HUMAN OTC DRUG Aplicare Povidone-Iodine Paint Povidone-Iodine SOLUTION TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 52380-4101_23bab150-4d5a-4ad1-a43c-bf46567cc07f 52380-4101 HUMAN OTC DRUG Aplicare Povidone Iodine Swabstick POVIDONE-IODINE SOLUTION TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 52380-4111_12984a6e-5fa7-475c-a06b-abfb1b8a79b2 52380-4111 HUMAN OTC DRUG Aplicare Povidone-Iodine Prep Pad POVIDONE-IODINE SOLUTION TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 52380-4124_5a660f4f-841a-4c66-8218-952ac0515621 52380-4124 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Sponge Sticks Povidone-iodine Scrub SOLUTION TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 52380-4125_719b52aa-5e18-44a9-af06-5c4ae11867b2 52380-4125 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Triples Povidone-iodine SOLUTION TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 7.5 mg/mL N 20181231 52380-4193_23aa7649-419e-4e68-a700-26cdc1557f16 52380-4193 HUMAN OTC DRUG Curity Povidone-Iodine One-Step Prep Povidone-Iodine GEL TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 9.7 g/mL E 20171231 52380-4801_133d258d-9a02-2865-e054-00144ff88e88 52380-4801 HUMAN OTC DRUG Aplicare Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52380-4802_5f9cab11-e1f6-272a-e053-2991aa0a37b8 52380-4802 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Povidone-iodine SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333A Aplicare, LLC POVIDONE-IODINE 7.5 mg/mL N 20181231 52380-4892_a4748740-ce76-4211-8957-f3e87ada6345 52380-4892 HUMAN OTC DRUG Curity Povidone-Iodine Scrub Povidone-Iodine SOLUTION TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 7.86 g/mL E 20171231 52380-4972_626183cc-0dee-e0db-e053-2a91aa0a88b6 52380-4972 HUMAN OTC DRUG Clorox Healthcare Nasal Antiseptic Swabs Povidone Iodine swabstick SOLUTION TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL N 20191231 52380-5101_38e27226-0286-4bdb-8af4-41d7376b5afa 52380-5101 HUMAN OTC DRUG Aplicare Povidone-iodine Triples Povidone-iodine SOLUTION TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 52380-5124_c1baa608-27fa-4efe-b0a4-b4c1c6c7489e 52380-5124 HUMAN OTC DRUG Aplicare Povidone-iodine Scrub Small Wing Sponge Povidone-iodine Scrub SOLUTION TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 52380-5972_d2416620-1ca4-4aa5-9819-322ef7d71f3b 52380-5972 HUMAN OTC DRUG Aplicare Povidone Iodine Swabstick Povidone Iodine SOLUTION TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 52380-7310_f097e630-cfad-47ce-bb53-3ec07c3d0943 52380-7310 HUMAN OTC DRUG Aplicare Total Joint Prep Povidone-iodine KIT TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. E 20171231 52380-9957_40f9d1b8-45c7-4044-e054-00144ff8d46c 52380-9957 HUMAN OTC DRUG PCMX with Emollient Chloroxylenol SOLUTION TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part333A Aplicare, Inc. CHLOROXYLENOL 3.3 mg/100mL E 20171231 52389-117_a495dd69-ce99-4c2e-8187-5e816c68092d 52389-117 HUMAN OTC DRUG Pep-Back Peak Performance Caffeine TABLET, FILM COATED ORAL 20070328 OTC MONOGRAPH FINAL part340 Alva-Amco Pharmacal Companies, Inc. CAFFEINE 200 mg/1 E 20171231 52389-118_c41a5f26-f050-4c31-9c69-1bb46bd611df 52389-118 HUMAN OTC DRUG Theradent Calcium acetate, potassium nitrate, potassium phosphate, sodium fluoride MOUTHWASH ORAL 20060717 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. CALCIUM ACETATE; POTASSIUM NITRATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM FLUORIDE 1; 6; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 52389-136_8d7c82eb-5a35-48fd-82fe-ef301997c01e 52389-136 HUMAN OTC DRUG Diurex Pamabrom CAPSULE, LIQUID FILLED ORAL 20000410 UNAPPROVED DRUG OTHER Alva-Amco Pharmacal Companies, Inc. PAMABROM 50 mg/1 N 20181231 52389-153_f6a8efd9-8ecc-4621-8486-6710199c238f 52389-153 HUMAN OTC DRUG BackAid Max acetaminophen, pamabrom TABLET, FILM COATED ORAL 19920201 OTC MONOGRAPH NOT FINAL part343 Alva-Amco Pharmacal Companies, Inc. ACETAMINOPHEN; PAMABROM 500; 25 mg/1; mg/1 N 20181231 52389-154_6065e704-93a6-4214-e053-2a91aa0a7947 52389-154 HUMAN OTC DRUG Pep-Back Ultra Caffeine TABLET, FILM COATED ORAL 19930408 OTC MONOGRAPH FINAL part340 Alva-Amco Pharmacal Companies, Inc. CAFFEINE 200 mg/1 N 20181231 52389-155_3084e0de-805f-4255-ae96-4a95f7d5a76c 52389-155 HUMAN OTC DRUG Diurex Ultra Caffeine TABLET, FILM COATED ORAL 20050901 OTC MONOGRAPH FINAL part340 Alva-Amco Pharmacal Companies, Inc. CAFFEINE 100 mg/1 N 20181231 52389-160_ff220f26-07a9-4828-ac94-17a75362f341 52389-160 HUMAN OTC DRUG Fungicure Manicure Pedicure Clotrimazole LIQUID TOPICAL 20020715 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. CLOTRIMAZOLE 10 mg/mL N 20181231 52389-161_919bfa4c-d186-45ce-8995-a45086436221 52389-161 HUMAN OTC DRUG Fungicure Ultra Original Formula Undecylenic acid LIQUID TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. UNDECYLENIC ACID 100 mg/mL N 20181231 52389-162_81611424-a7d6-4a12-af30-f1877caa60c7 52389-162 HUMAN OTC DRUG Fungicure Tolnaftate GEL TOPICAL 19941001 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. TOLNAFTATE 10 mg/g N 20181231 52389-166_80d8b289-e89a-48f3-a2aa-9afef9e2861f 52389-166 HUMAN OTC DRUG Psoriasin Gel Coal Tar Topical Gel GEL TOPICAL 19960218 OTC MONOGRAPH FINAL part358H Alva-Amco Pharmacal Companies, Inc. COAL TAR 12.5 mg/g N 20181231 52389-168_6e6c0678-0385-493d-baa6-b598f7535ab7 52389-168 HUMAN OTC DRUG Fungicure Professional Formula Undecylenic Acid LIQUID TOPICAL 20050127 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. UNDECYLENIC ACID 125 mg/mL N 20181231 52389-169_e884fcee-5844-4e53-bb71-92485743cffc 52389-169 HUMAN OTC DRUG Psoriasin Coal Tar LIQUID TOPICAL 20020120 OTC MONOGRAPH FINAL part358 Alva-Amco Pharmacal Companies, Inc. COAL TAR 6.6 mg/mL N 20181231 52389-171_a7138a76-0ec2-453c-9404-af6b8f4f1b5a 52389-171 HUMAN OTC DRUG Psoriasin Therapeutic Shampoo and Body Wash Salicylic acid SHAMPOO TOPICAL 19990228 OTC MONOGRAPH FINAL part358 Alva-Amco Pharmacal Companies, Inc. SALICYLIC ACID 3 g/100g N 20181231 52389-172_b35b5e0f-9b2e-40ae-9db7-65f245e40844 52389-172 HUMAN OTC DRUG Nauzene Sodium Citrate SYRUP ORAL 20000215 OTC MONOGRAPH NOT FINAL part357 Alva-Amco Pharmacal Companies, Inc. TRISODIUM CITRATE DIHYDRATE; DEXTROSE; FRUCTOSE .921; 4.35; 4.17 g/15mL; g/15mL; g/15mL N 20181231 52389-173_6b36042f-3248-4b90-ac45-55c546cc7bb4 52389-173 HUMAN OTC DRUG Prosacea Sulphur GEL TOPICAL 20060206 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. SULFUR 1 [hp_X]/g N 20181231 52389-178_2bc4888d-1c0f-463b-b4e2-eebeb8980290 52389-178 HUMAN OTC DRUG Psoriasin Coal Tar OINTMENT TOPICAL 20040601 OTC MONOGRAPH FINAL part358H Alva-Amco Pharmacal Companies, Inc. COAL TAR 20 mg/g N 20181231 52389-179_45a475d4-a736-4afe-a06f-a5a8fa02c0ac 52389-179 HUMAN OTC DRUG Herpetrol Benzalkonium chloride, menthol, petrolatum OINTMENT TOPICAL 20050630 OTC MONOGRAPH FINAL part348 Alva-Amco Pharmacal Companies, Inc. BENZALKONIUM CHLORIDE; MENTHOL; PETROLATUM 1.3; 10; 970 mg/g; mg/g; mg/g N 20181231 52389-198_3075cedb-a808-451c-9c0f-ae5ba5e8de3f 52389-198 HUMAN OTC DRUG Fungicure Maximum Strength Undecylenic Acid LIQUID TOPICAL 20050127 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. UNDECYLENIC ACID 250 mg/mL N 20181231 52389-226_d07e805d-c0f0-435d-ae2a-75102d85f3c0 52389-226 HUMAN OTC DRUG Fungicure Anti-Fungal Wash Sepia SOAP TOPICAL 20160307 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. SEPIA OFFICINALIS JUICE 12 [hp_X]/mL N 20181231 52389-237_681ee36d-5a4f-4ee5-b60a-e5aa35f45668 52389-237 HUMAN OTC DRUG Arthriten Inflammatory Pain Formula acetaminophen, aspirin, caffeine TABLET, FILM COATED ORAL 20120723 OTC MONOGRAPH NOT FINAL part343 Alva-Amco Pharmacal Companies, Inc. ACETAMINOPHEN; CAFFEINE; ASPIRIN 250; 65; 250 mg/1; mg/1; mg/1 N 20181231 52389-241_647913b8-246e-2774-e053-2991aa0a227c 52389-241 HUMAN OTC DRUG Uricalm Maximum Strength Phenazopyridine Hydochloride TABLET, FILM COATED ORAL 20080429 UNAPPROVED DRUG OTHER Alva-Amco Pharmacal Companies, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg/1 N 20191231 52389-242_a271406b-1a71-4da1-92b0-86340fcf655e 52389-242 HUMAN OTC DRUG Nauzene Sodium Citrate TABLET, CHEWABLE ORAL 20000708 UNAPPROVED DRUG OTHER Alva-Amco Pharmacal Companies, Inc. TRISODIUM CITRATE DIHYDRATE 230 mg/1 N 20181231 52389-249_ebd1ed34-36c3-47d8-a0fd-c9f0f05e8b9b 52389-249 HUMAN OTC DRUG Diurex Max Pamabrom TABLET, FILM COATED ORAL 19951220 UNAPPROVED DRUG OTHER Alva-Amco Pharmacal Companies, Inc. PAMABROM 50 mg/1 N 20181231 52389-263_7171e9e6-f2a0-4b32-92b8-400447de241d 52389-263 HUMAN OTC DRUG Fungicure Pumpspray Clotrimazole LIQUID TOPICAL 20020301 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. CLOTRIMAZOLE 10 mg/mL N 20181231 52389-266_f26876dc-c0ab-4a3f-bfa4-d50b361eeb30 52389-266 HUMAN OTC DRUG Psoriasin Coal Tar GEL TOPICAL 19960218 OTC MONOGRAPH FINAL part358H Alva-Amco Pharmacal Companies, Inc. COAL TAR 12.5 mg/g N 20181231 52389-306_cce6bd0a-3e5c-4018-8ead-705401c1e918 52389-306 HUMAN OTC DRUG Diurex Water Pills Caffeine, magnesium salicylate TABLET, COATED ORAL 20050515 OTC MONOGRAPH NOT FINAL part343 Alva-Amco Pharmacal Companies, Inc. MAGNESIUM SALICYLATE; CAFFEINE 162.5; 50 mg/1; mg/1 N 20181231 52389-325_73631e02-c1cb-4c81-8ea8-80f49940423d 52389-325 HUMAN OTC DRUG Diurex Pamabrom CAPSULE ORAL 20050401 UNAPPROVED DRUG OTHER Alva-Amco Pharmacal Companies, Inc. PAMABROM 50 mg/1 N 20181231 52389-337_5fb94370-15ae-45f3-9169-b2f4a94df820 52389-337 HUMAN OTC DRUG Arthriten Max acetaminophen, aspirin, caffeine TABLET, FILM COATED ORAL 20170824 OTC MONOGRAPH NOT FINAL part343 Alva-Amco Pharmacal Companies, Inc. ACETAMINOPHEN; CAFFEINE; ASPIRIN 250; 65; 250 mg/1; mg/1; mg/1 N 20181231 52389-406_f21479c2-8269-4313-afcd-7e0f5dbcc24b 52389-406 HUMAN OTC DRUG Diurex Water Pills XPL Caffeine TABLET, FILM COATED ORAL 20160817 UNAPPROVED DRUG OTHER Alva-Amco Pharmacal Companies, Inc. CAFFEINE 100 mg/1 N 20181231 52389-600_747023df-5bca-4fad-87d1-d6170cbe8840 52389-600 HUMAN OTC DRUG Fungicure Intensive Clotrimazole LIQUID TOPICAL 20080605 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. CLOTRIMAZOLE 10 mg/mL N 20181231 52389-606_09c1c792-a69b-4165-bb76-ca9f04b18c08 52389-606 HUMAN OTC DRUG Acnevir Facial Wash Salicylic Acid SOAP TOPICAL 20091201 OTC MONOGRAPH FINAL part333D Alva-Amco Pharmacal Companies, Inc. SALICYLIC ACID 2 g/100g N 20181231 52389-608_eab3a69b-1893-4b5d-996f-68cd7e7f9c2e 52389-608 HUMAN OTC DRUG AcneVir Sulphur, resorcinol, salicylic acid GEL TOPICAL 20091201 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. SULFUR; RESORCINOL; SALICYLIC ACID 1; 2; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 52389-610_ab6524fe-005d-4d4b-abd0-10c7f2d062e8 52389-610 HUMAN OTC DRUG Tranquil Nighttime Diphenhydramine Hydrochloride TABLET ORAL 20100830 OTC MONOGRAPH FINAL part338 Alva-Amco Pharmacal Companies, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 52389-612_a66d47e3-6449-488c-956b-e2247e76b2d4 52389-612 HUMAN OTC DRUG Nauzene Motion Bryonia alba root, sepia TABLET, COATED ORAL 20110915 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. BRYONIA ALBA ROOT; SEPIA OFFICINALIS JUICE 3; 12 [hp_X]/1; [hp_X]/1 N 20181231 52389-613_992f7ac1-ecda-4bd2-863e-9630c9c77f19 52389-613 HUMAN OTC DRUG Diurex WaterCaps Caffeine TABLET, FILM COATED ORAL 20090415 OTC MONOGRAPH NOT FINAL part357 Alva-Amco Pharmacal Companies, Inc. CAFFEINE 200 mg/1 E 20171231 52389-621_5b4d0493-5521-4d45-e053-2a91aa0ab81c 52389-621 HUMAN OTC DRUG Nauzene Homeopathic Lactic acid, wild hops LIQUID ORAL 20140408 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. BRYONIA ALBA ROOT; LACTIC ACID 3; 3 [hp_X]/15mL; [hp_X]/15mL N 20181231 52389-622_b1dc7b4d-ef8d-4d00-90f1-107eb34e4fc5 52389-622 HUMAN OTC DRUG BackAid Inflammatory Pain Formula acetaminophen, aspirin, caffeine TABLET, FILM COATED ORAL 20121022 OTC MONOGRAPH NOT FINAL part343 Alva-Amco Pharmacal Companies, Inc. ACETAMINOPHEN; CAFFEINE; ASPIRIN 250; 65; 250 mg/1; mg/1; mg/1 N 20181231 52389-623_d83a2f05-31bd-4ca9-be49-3953df23d861 52389-623 HUMAN OTC DRUG Verticalm Meclizine Hydrochloride TABLET ORAL 20120416 OTC MONOGRAPH FINAL part336 Alva-Amco Pharmacal Companies, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 52389-627_7ee39721-9642-428f-9cd1-30f9a532cc53 52389-627 HUMAN OTC DRUG Psoriasin Medicated Wash Salicylic acid SOAP TOPICAL 20110102 OTC MONOGRAPH FINAL part358H Alva-Amco Pharmacal Companies, Inc. SALICYLIC ACID 3 g/100g N 20181231 52389-628_39075e22-6df7-48b1-9aa8-2aef6cde31e8 52389-628 HUMAN OTC DRUG Eczemin Pramoxine Hydrochloride CREAM TOPICAL 20111116 OTC MONOGRAPH NOT FINAL part348 Alva-Amco Pharmacal Companies, Inc. PRAMOXINE HYDROCHLORIDE 10 mg/g N 20181231 52389-633_36ebed05-b706-4812-ada0-6853f1f75f84 52389-633 HUMAN OTC DRUG Fungicure LiquidGel Undecylenic Acid GEL TOPICAL 20121130 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. UNDECYLENIC ACID 250 mg/g N 20181231 52389-638_99955b20-ec50-4524-8746-7a94f7e73ac3 52389-638 HUMAN OTC DRUG Lysimax Benzalkonium chloride, menthol, petrolatum OINTMENT TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part348 Alva-Amco Pharmacal Companies, Inc. BENZALKONIUM CHLORIDE; MENTHOL; PETROLATUM 1.3; 10; 970 mg/g; mg/g; mg/g N 20181231 52389-639_74147f45-a74b-48a4-9127-983f5dfbe341 52389-639 HUMAN OTC DRUG Fungicure Athletes Foot Tolnaftate 1% CREAM TOPICAL 20140326 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc TOLNAFTATE 10 mg/g N 20181231 52389-642_f474c04d-75fb-47f7-880a-9e68b676d114 52389-642 HUMAN OTC DRUG Uricalm Intensive acetaminophen, aspirin, caffeine TABLET, FILM COATED ORAL 20130923 OTC MONOGRAPH NOT FINAL part343 Alva-Amco Pharmacal Companies, Inc. ACETAMINOPHEN; CAFFEINE; ASPIRIN 250; 65; 250 mg/1; mg/1; mg/1 N 20181231 52389-645_28030fb2-63d8-4b44-e054-00144ff8d46c 52389-645 HUMAN OTC DRUG Psoriasin Advanced Treatment Coal tar CREAM TOPICAL 20150215 OTC MONOGRAPH FINAL part358H Alva-Amco Pharmacal Companies, Inc. COAL TAR 12.5 mg/g N 20181231 52389-647_939836be-8088-4187-8407-4c1033d48f48 52389-647 HUMAN OTC DRUG Fungicure Manicure Pedicure Liquid Gel Clotrimazole GEL TOPICAL 20160705 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. CLOTRIMAZOLE 10 mg/g N 20181231 52389-649_78749d1d-c179-4348-ae8d-6b131aa1a86d 52389-649 HUMAN OTC DRUG Psoriasin Itch Control Hydrocortisone Cream CREAM TOPICAL 20160222 OTC MONOGRAPH NOT FINAL part348 Alva-Amco Pharmacal Companies, Inc. HYDROCORTISONE 10 mg/g N 20181231 52389-652_0af6804a-7387-492e-8b71-cd460f7a4907 52389-652 HUMAN OTC DRUG Psoriasin Deep Moisturizing Coal Tar OINTMENT TOPICAL 20170310 OTC MONOGRAPH FINAL part358H Alva-Amco Pharmacal Companies, Inc. COAL TAR 20 mg/g N 20181231 52389-656_60655aee-db57-2064-e053-2991aa0aa0f2 52389-656 HUMAN OTC DRUG Diurex Ultimate Caffeine TABLET, FILM COATED ORAL 20151031 UNAPPROVED DRUG OTHER Alva-Amco Pharmacal Companies, Inc. CAFFEINE 100 mg/1 N 20181231 52389-733_6029037c-f93f-1bf7-e053-2991aa0a5efc 52389-733 HUMAN OTC DRUG Fungicure Liquid Gel Clotrimazole GEL TOPICAL 20151231 OTC MONOGRAPH FINAL part333C Alva-Amco Pharmacal Companies, Inc. CLOTRIMAZOLE 10 mg/g N 20181231 52389-745_647a5d50-e971-7deb-e053-2a91aa0aba4f 52389-745 HUMAN OTC DRUG Psoriasin Daytime Relief Coal tar CREAM TOPICAL 20160701 OTC MONOGRAPH FINAL part358H Alva-Amco Pharmacal Companies, Inc. COAL TAR 12.5 mg/g N 20191231 52389-829_f49c949d-6a19-4888-83da-3430700a39eb 52389-829 HUMAN OTC DRUG Nauzene Lactic acid, wild hops LIQUID ORAL 20120424 UNAPPROVED HOMEOPATHIC Alva-Amco Pharmacal Companies, Inc. BRYONIA ALBA ROOT; LACTIC ACID 3; 3 [hp_X]/15mL; [hp_X]/15mL N 20181231 52410-0200_35d5f498-0a9e-60c5-e054-00144ff8d46c 52410-0200 HUMAN OTC DRUG NATURES REALM VAPORIZING CHEST RUB Menthol Camphor Eucalyptus Oil GEL TOPICAL 20090921 OTC MONOGRAPH FINAL part341 Shield Line LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 5.3; 1.13; 2.26 g/113g; g/113g; g/113g E 20171231 52410-0201_35d523ac-85e0-3a92-e054-00144ff8d46c 52410-0201 HUMAN OTC DRUG Cool Hot Ice Analgesic Gel Menthol GEL TOPICAL 20090921 OTC MONOGRAPH FINAL part341 SHIELD LINE LLC MENTHOL 2.27 g/227g E 20171231 52410-0202_35c163e6-ae59-2791-e054-00144ff8d46c 52410-0202 HUMAN OTC DRUG PURE PETROLEUM Petrolatum JELLY TOPICAL 20160621 OTC MONOGRAPH FINAL part347 Shield Line LLC PETROLATUM 100 g/100g E 20171231 52410-0203_35bfce89-a74d-2458-e054-00144ff8d46c 52410-0203 HUMAN OTC DRUG Petrolatum Jelly with Cocoa Butter Petrolatum JELLY TOPICAL 20160624 OTC MONOGRAPH FINAL part347 Shield Line LLC PETROLATUM 99.9 g/100g E 20171231 52410-0206_35c163e6-ae42-2791-e054-00144ff8d46c 52410-0206 HUMAN OTC DRUG Baby Petrolatum Jelly Petrolatum JELLY TOPICAL 20160621 OTC MONOGRAPH FINAL part347 SHIELD LINE LLC PETROLATUM 99.9 g/100g E 20171231 52410-0207_35c25d77-dec5-44d1-e054-00144ff8d46c 52410-0207 HUMAN OTC DRUG Petrolatum Jelly with Lavender Petrolatum JELLY TOPICAL 20160621 OTC MONOGRAPH FINAL part347 SHIELD LINE LLC PETROLATUM 99.9 g/100g E 20171231 52410-1010_3ec2cb33-b1af-513e-e054-00144ff88e88 52410-1010 HUMAN OTC DRUG Novita Pure Petrolatum Jelly Petrolatum JELLY TOPICAL 20161015 OTC MONOGRAPH FINAL part347 Shield Line LLC PETROLATUM 100 g/100g N 20181231 52410-1011_3ec28fd9-fd8c-4865-e054-00144ff88e88 52410-1011 HUMAN OTC DRUG Novita Petrolatum with Cocoa Butter Petrolatum JELLY TOPICAL 20161012 OTC MONOGRAPH FINAL part347 Shield line LLC PETROLATUM 99.9 g/100g N 20181231 52410-1020_3e9d4992-5c1b-16d9-e054-00144ff88e88 52410-1020 HUMAN OTC DRUG Novita Petrolatum Jelly Pink Petrolatum JELLY TOPICAL 20161011 OTC MONOGRAPH FINAL part347 Shield Line LLC PETROLATUM 99.9 g/100g N 20181231 52410-1021_3ec26e4b-907e-386d-e054-00144ff8d46c 52410-1021 HUMAN OTC DRUG Novita Baby Petrolatum Jelly Petrolatum JELLY TOPICAL 20161011 OTC MONOGRAPH FINAL part347 Shield Line LLC PETROLATUM 99.9 g/100g N 20181231 52410-1050_3ad79e91-377e-6587-e054-00144ff8d46c 52410-1050 HUMAN OTC DRUG NOVITA ISOPROPYL ALCOHOL 50% Isopropyl Alcohol LIQUID TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 52410-1051_3bd9fc61-b136-51f5-e054-00144ff8d46c 52410-1051 HUMAN OTC DRUG NOVITA 50% ISOPROPYL RUBBING ALCOHOL W/ WINTERGREEN ISOPROPYL ALCOHOL LIQUID TOPICAL 20160906 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 52410-1060_3ad4e295-2056-0639-e054-00144ff88e88 52410-1060 HUMAN OTC DRUG NOVITA ISOPROPYL RUBBING ALCOHOL Isopropyl Alcohol LIQUID TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 52410-1061_3b8ce60e-6f1c-11e0-e054-00144ff88e88 52410-1061 HUMAN OTC DRUG NOVITA 70% ISOPROPYL RUBBING ALCOHOL WINTERGREEN Isopropyl Alcohol LIQUID TOPICAL 20160906 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 52410-3020_5940c70b-09c2-21e2-e053-2991aa0a4f43 52410-3020 HUMAN OTC DRUG Medpride White Petrolatum OINTMENT TOPICAL 20130523 OTC MONOGRAPH FINAL part347 Shield Line LLC PETROLATUM 100 g/100g N 20181231 52410-3025_59416029-e45d-5bd9-e053-2a91aa0a337f 52410-3025 HUMAN OTC DRUG Medpride First Aid Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate OINTMENT TOPICAL 20130517 OTC MONOGRAPH FINAL part333B Shield Line LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 52410-3035_59404085-ac50-794d-e053-2991aa0abbc5 52410-3035 HUMAN OTC DRUG Medpride First Aid Bacitracin Zinc OINTMENT TOPICAL 20130530 OTC MONOGRAPH FINAL part333B Shield Line LLC BACITRACIN ZINC 500 [USP'U]/g N 20181231 52410-3040_59416029-e46b-5bd9-e053-2a91aa0a337f 52410-3040 HUMAN OTC DRUG Medpride Zinc Oxide OINTMENT TOPICAL 20130523 OTC MONOGRAPH FINAL part347 Shield Line LLC ZINC OXIDE 20 g/100g N 20181231 52410-3045_58761d1b-6d69-b96b-e053-2a91aa0a3d24 52410-3045 HUMAN OTC DRUG Medpride Vitamin A and D White Petrolatum OINTMENT TOPICAL 20130523 OTC MONOGRAPH FINAL part347 Shield Line LLC PETROLATUM 76 g/100g N 20181231 52410-3050_59416029-e478-5bd9-e053-2a91aa0a337f 52410-3050 HUMAN OTC DRUG MedPride Hydrocortisone CREAM TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part348 Shield Line LLC HYDROCORTISONE ACETATE 10 mg/g N 20181231 52410-3060_59416029-e486-5bd9-e053-2a91aa0a337f 52410-3060 HUMAN OTC DRUG Medpride EN SHIELD ALOE SOFT VITAMIN ENRICHED ZINC OXIDE CREAM TOPICAL 20130527 OTC MONOGRAPH FINAL part347 Shield Line LLC ZINC OXIDE 1.8 g/100g N 20181231 52410-3065_b1d4b6a3-7484-4674-9598-42cd3a12358c 52410-3065 HUMAN OTC DRUG Medpride En Shield ZINC OXIDE DIMETHICONE CREAM TOPICAL 20130527 OTC MONOGRAPH FINAL part347 Shield Line LLC ZINC OXIDE; DIMETHICONE 1.8; 1.8 g/100g; g/100g E 20171231 52410-3066_59416029-e493-5bd9-e053-2a91aa0a337f 52410-3066 HUMAN OTC DRUG Medpride EN SHIELD ALOE SOFT VITAMIN ENRICHED ZINC OXIDE CREAM TOPICAL 20130527 OTC MONOGRAPH FINAL part347 Shield Line LLC ZINC OXIDE 3.8 g/100g N 20181231 52410-4096_5de01bb3-a057-e457-e053-2991aa0aa59e 52410-4096 HUMAN OTC DRUG MedPRIDE Isopropyl Alcohol LIQUID TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 52410-4097_5de07451-754a-47f4-e053-2991aa0a7b90 52410-4097 HUMAN OTC DRUG MedPRIDE with Wintergreen Oil Isopropyl Alcohol LIQUID TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 52410-4110_60a542d8-92dd-0324-e053-2a91aa0a95da 52410-4110 HUMAN OTC DRUG MedPride Sterile Prep Pads Isopropyl Alcohol CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC ISOPROPYL ALCOHOL .7 g/1 N 20181231 52410-4112_60a56cf5-6f23-4530-e053-2a91aa0afa71 52410-4112 HUMAN OTC DRUG MedPride Isopropyl Alcohol CLOTH TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC ISOPROPYL ALCOHOL .7 mL/1 N 20181231 52410-4115_60b9137d-a6b4-a0c6-e053-2a91aa0ab7df 52410-4115 HUMAN OTC DRUG MedPride PrepPads Povidone Iodine SOLUTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC POVIDONE-IODINE .1 g/1 N 20181231 52410-4150_bbd5cebd-8de1-4b37-90f7-211033d92a2a 52410-4150 HUMAN OTC DRUG MedPride Sterile Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC BENZALKONIUM CHLORIDE .133 g/1 N 20181231 52410-6135_9a965bdc-7f93-4981-9469-22f6d6524eab 52410-6135 HUMAN OTC DRUG MedPride Lemon Glycerin SWAB ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 Shield Line LLC GLYCERIN .075 g/1 N 20181231 52410-6138_2779958a-18ea-44b6-b21a-91419376c856 52410-6138 HUMAN OTC DRUG MedPride Isopropyl Alcohol SWAB TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC ISOPROPYL ALCOHOL .7 mL/1 N 20181231 52410-6141_7c35f1b9-f909-4672-b7b6-5b2bfbcce8dc 52410-6141 HUMAN OTC DRUG MedPride Swabsticks Povidone Iodine SOLUTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part333A Shield Line LLC POVIDONE-IODINE .1 g/1 N 20181231 52410-8020_5940711d-719a-cb7d-e053-2a91aa0aef18 52410-8020 HUMAN OTC DRUG AmeriDerm PeriShield ZINC OXIDE OINTMENT TOPICAL 20150101 OTC MONOGRAPH FINAL part347 Shield Line LLC ZINC OXIDE 3.8 g/100g N 20181231 52410-8036_9466be1a-6756-4004-bbf1-2c37c9a3177a 52410-8036 HUMAN OTC DRUG AmeriDerm Vitamin A D White Petrolatum OINTMENT TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Shield Line LLC PETROLATUM 76 g/100g E 20171231 52410-8050_3ec0dcbf-c807-57db-e054-00144ff8d46c 52410-8050 HUMAN OTC DRUG AmeriDerm DermaFix Lanolin OINTMENT TOPICAL 20150201 OTC MONOGRAPH FINAL part347 Shield Line LLC LANOLIN 22 g/100g E 20171231 52410-8072_33add4b8-2968-0828-e054-00144ff8d46c 52410-8072 HUMAN OTC DRUG AmeriDerm Antibacterial Wash Chloroxylenol LIQUID TOPICAL 20160725 OTC MONOGRAPH NOT FINAL part333E SHIELD LINE LLC CHLOROXYLENOL 5 mg/mL E 20171231 52410-8080_34ca8ec4-782b-053e-e054-00144ff88e88 52410-8080 HUMAN OTC DRUG AmeriDerm Foam Alcohol Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20160725 OTC MONOGRAPH NOT FINAL part333E Shield Line LLC ALCOHOL 700 mg/mL E 20171231 52410-9005_e2b01b92-3c12-46d9-b6e3-46542f670c8a 52410-9005 HUMAN OTC DRUG Medpride Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20130527 OTC MONOGRAPH FINAL part355 Shield Line LLC SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 52412-100_a23b5195-518e-4093-aea4-10ce96460ee2 52412-100 HUMAN OTC DRUG Dormin Diphenhydramine Hydrochloride CAPSULE ORAL 19920101 OTC MONOGRAPH FINAL part338 Randob Labs,Ltd. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 52412-200_b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701 52412-200 HUMAN OTC DRUG Sting-Kill Benzocaine and Menthol SOLUTION TOPICAL 19650101 OTC MONOGRAPH NOT FINAL part348 Randob Ltd. BENZOCAINE; MENTHOL 200; 10 mg/mL; mg/mL N 20181231 52412-250_b6b84806-0cda-43ca-99ef-3eed522aa864 52412-250 HUMAN OTC DRUG Sting-Kill Benzocaine and Menthol SOLUTION TOPICAL 19650101 OTC MONOGRAPH NOT FINAL part348 Randob Ltd. BENZOCAINE; MENTHOL 200; 10 mg/mL; mg/mL N 20181231 52412-300_5ca5f00d-4160-420a-a909-f29426a745e2 52412-300 HUMAN OTC DRUG Fire Out Benzocaine and Menthol SOLUTION TOPICAL 20160215 OTC MONOGRAPH NOT FINAL part348 Randob Ltd. BENZOCAINE; MENTHOL 200; 10 mg/mL; mg/mL N 20181231 52424-0001_f94a641a-9896-4353-ac91-6c01e65a4baf 52424-0001 HUMAN OTC DRUG BIO BEAUTY BIO DEFENSE TINTED FOUNDATION SPF 18 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part352 LIBINVEST OCTINOXATE; TITANIUM DIOXIDE 7.5; 8 g/100mL; g/100mL E 20171231 52424-0002_f94a641a-9896-4353-ac91-6c01e65a4baf 52424-0002 HUMAN OTC DRUG BIO BEAUTY BIO DEFENSE TINTED FOUNDATION SPF 18 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100620 OTC MONOGRAPH NOT FINAL part352 LIBINVEST OCTINOXATE; TITANIUM DIOXIDE 7.5; 8 g/100mL; g/100mL E 20171231 52426-020_6d037501-669e-491c-99ff-6452e2753391 52426-020 HUMAN OTC DRUG Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 20100923 OTC MONOGRAPH FINAL part333B Phoenix Global Supply Group, Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 52426-120_b0f4a5d9-9d8a-4f62-ba9d-3d383989323a 52426-120 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20100923 OTC MONOGRAPH FINAL part333B Phoenix Global Supply Group, Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 52426-220_5328de28-f628-4f1c-b03e-03ad9a98c796 52426-220 HUMAN OTC DRUG Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20100923 OTC MONOGRAPH FINAL part333B Phoenix Global Supply Group, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 52426-220_ad7a427d-3ad0-4a47-8e2f-223b9242bd90 52426-220 HUMAN OTC DRUG ANTIBIOTIC PLUS PAIN RELIEF Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20110701 OTC MONOGRAPH FINAL part333B Phoenix Global Supply Group, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 52426-320_fb4d1f7b-1818-4155-978b-fc7bd5865eac 52426-320 HUMAN OTC DRUG Bacitracin Bacitracin zinc OINTMENT TOPICAL 20110401 OTC MONOGRAPH FINAL part333B Phoenix Global Supply Group, Inc BACITRACIN ZINC 500 [iU]/g E 20171231 52426-420_4a970118-6a7f-4fa1-b822-442a96d20f5b 52426-420 HUMAN OTC DRUG Poly Bacitracin Bacitracin zinc and Polymyxin B sulfate OINTMENT TOPICAL 20100923 OTC MONOGRAPH FINAL part333B Phoenix Global Supply Group, Inc BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [iU]/g; [iU]/g E 20171231 52426-520_adee22b6-9680-45c2-87c5-332424f62cbb 52426-520 HUMAN OTC DRUG Myxcin-C Hexylresorcinol SOLUTION TOPICAL 20110215 OTC MONOGRAPH NOT FINAL part333A Phoenix Global Supply Group, Inc. HEXYLRESORCINOL 1.1 mg/mL N 20181231 52427-272_301deb49-475b-b22b-8b24-b462bc7b1a2c 52427-272 HUMAN PRESCRIPTION DRUG Naprelan Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140117 NDA NDA020353 ALMATICA PHARMA INC. NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52427-273_301deb49-475b-b22b-8b24-b462bc7b1a2c 52427-273 HUMAN PRESCRIPTION DRUG Naprelan Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140117 NDA NDA020353 ALMATICA PHARMA INC. NAPROXEN SODIUM 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52427-274_301deb49-475b-b22b-8b24-b462bc7b1a2c 52427-274 HUMAN PRESCRIPTION DRUG Naprelan Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140117 NDA NDA020353 ALMATICA PHARMA INC. NAPROXEN SODIUM 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52427-285_2ebd3e64-8ffd-53e8-b62f-22154a40e532 52427-285 HUMAN PRESCRIPTION DRUG Macrobid Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110531 NDA NDA020064 Almatica Pharma Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 52427-286_6bdfedd5-b9ea-d185-64ee-e4982a57eb5a 52427-286 HUMAN PRESCRIPTION DRUG Macrodantin Nitrofurantoin macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Almatica Pharma Inc. NITROFURANTOIN 25 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 52427-287_6bdfedd5-b9ea-d185-64ee-e4982a57eb5a 52427-287 HUMAN PRESCRIPTION DRUG Macrodantin Nitrofurantoin macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Almatica Pharma Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 52427-288_6bdfedd5-b9ea-d185-64ee-e4982a57eb5a 52427-288 HUMAN PRESCRIPTION DRUG Macrodantin Nitrofurantoin macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Almatica Pharma Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 52427-382_01da4c33-9533-8317-9de8-dfe6d24e893a 52427-382 HUMAN PRESCRIPTION DRUG TENORETIC Atenolol and Chlorthalidone TABLET ORAL 20150421 NDA NDA018760 Almatica Pharma Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 52427-383_01da4c33-9533-8317-9de8-dfe6d24e893a 52427-383 HUMAN PRESCRIPTION DRUG TENORETIC Atenolol and Chlorthalidone TABLET ORAL 20150421 NDA NDA018760 Almatica Pharma Inc. ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 52427-429_5bf1cb87-f3a6-92f7-b765-f67e5c487fec 52427-429 HUMAN PRESCRIPTION DRUG TENORMIN Atenolol TABLET ORAL 20150415 NDA NDA018240 Almatica Pharma Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 52427-430_5bf1cb87-f3a6-92f7-b765-f67e5c487fec 52427-430 HUMAN PRESCRIPTION DRUG TENORMIN Atenolol TABLET ORAL 20150415 NDA NDA018240 Almatica Pharma Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 52427-431_5bf1cb87-f3a6-92f7-b765-f67e5c487fec 52427-431 HUMAN PRESCRIPTION DRUG TENORMIN Atenolol TABLET ORAL 20150415 NDA NDA018240 Almatica Pharma Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 52427-435_cdfe92d1-a548-06a2-e2d6-e89ff5be0f3e 52427-435 HUMAN PRESCRIPTION DRUG Zestoretic lisinopril and hydrochlorothiazide TABLET ORAL 20150415 NDA NDA019888 Almatica Pharma Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 52427-436_cdfe92d1-a548-06a2-e2d6-e89ff5be0f3e 52427-436 HUMAN PRESCRIPTION DRUG Zestoretic lisinopril and hydrochlorothiazide TABLET ORAL 20150415 NDA NDA019888 Almatica Pharma Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 52427-437_cdfe92d1-a548-06a2-e2d6-e89ff5be0f3e 52427-437 HUMAN PRESCRIPTION DRUG Zestoretic lisinopril and hydrochlorothiazide TABLET ORAL 20150415 NDA NDA019888 Almatica Pharma Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 52427-438_29da36aa-751f-bddc-d06a-db9ffcb66095 52427-438 HUMAN PRESCRIPTION DRUG Zestril Lisinopril TABLET ORAL 20150407 NDA NDA019777 Almatica Pharma Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 52427-439_29da36aa-751f-bddc-d06a-db9ffcb66095 52427-439 HUMAN PRESCRIPTION DRUG Zestril Lisinopril TABLET ORAL 20150407 NDA NDA019777 Almatica Pharma Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 52427-440_29da36aa-751f-bddc-d06a-db9ffcb66095 52427-440 HUMAN PRESCRIPTION DRUG Zestril Lisinopril TABLET ORAL 20150407 NDA NDA019777 Almatica Pharma Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 52427-441_29da36aa-751f-bddc-d06a-db9ffcb66095 52427-441 HUMAN PRESCRIPTION DRUG Zestril Lisinopril TABLET ORAL 20150407 NDA NDA019777 Almatica Pharma Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 52427-442_29da36aa-751f-bddc-d06a-db9ffcb66095 52427-442 HUMAN PRESCRIPTION DRUG Zestril Lisinopril TABLET ORAL 20150407 NDA NDA019777 Almatica Pharma Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 52427-443_29da36aa-751f-bddc-d06a-db9ffcb66095 52427-443 HUMAN PRESCRIPTION DRUG Zestril Lisinopril TABLET ORAL 20150407 NDA NDA019777 Almatica Pharma Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 52427-494_c721303f-6dc4-988b-4f43-e8188888b48e 52427-494 HUMAN PRESCRIPTION DRUG Adalat CC nifedipine TABLET, FILM COATED ORAL 20170201 NDA NDA020198 Almatica Pharma Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 52427-495_c721303f-6dc4-988b-4f43-e8188888b48e 52427-495 HUMAN PRESCRIPTION DRUG Adalat CC nifedipine TABLET, FILM COATED ORAL 20170201 NDA NDA020198 Almatica Pharma Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 52427-496_c721303f-6dc4-988b-4f43-e8188888b48e 52427-496 HUMAN PRESCRIPTION DRUG Adalat CC nifedipine TABLET, FILM COATED ORAL 20170201 NDA NDA020198 Almatica Pharma Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 52427-575_f809abb6-9387-1c13-b4e8-60dc6e95cb7a 52427-575 HUMAN PRESCRIPTION DRUG Forfivo XL bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170515 NDA NDA022497 Almatica Pharma Inc. BUPROPION HYDROCHLORIDE 450 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 52427-576_136880b6-b6c1-2e87-628b-b73d6a522bd2 52427-576 HUMAN PRESCRIPTION DRUG Fluoxetine HCl Fluoxetine HCl TABLET, FILM COATED ORAL 20170901 NDA NDA202133 Almatica Pharma Inc. FLUOXETINE HYDROCHLORIDE 60 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52428-001_4e17c42c-6bb9-40e2-b2bd-04ab33852518 52428-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20100616 UNAPPROVED MEDICAL GAS Arkansas Home Medical OXYGEN 99 L/100L E 20171231 52429-123_01df705a-5399-4014-a292-b3e922ba3dee 52429-123 HUMAN OTC DRUG NasalAsalt All-Natural Seawater Sodium Chloride SPRAY NASAL 20111101 OTC MONOGRAPH FINAL part349 Nasal and Sinus Health, Inc. SODIUM CHLORIDE 2600 mg/100mL N 20181231 52429-124_42549b28-7afe-4f59-97fc-2dca2ff816bd 52429-124 HUMAN OTC DRUG Breathe the Sea All-Natural Seawater Sodium Chloride SPRAY NASAL 20120301 UNAPPROVED DRUG OTHER Nasal and Sinus Health, Inc. SODIUM CHLORIDE 2600 mg/100mL N 20181231 52438-011_125b69e1-6d10-438d-b3e0-c896b75c3fe4 52438-011 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205767 Linde LLC OXYGEN 995 mL/L N 20181231 52438-014_4de9ee3c-901a-4deb-a6d9-e70423dd4cfc 52438-014 HUMAN PRESCRIPTION DRUG Carbon Dioxide Refrigerated Carbon Dioxide GAS RESPIRATORY (INHALATION) 19650101 NDA NDA205764 Linde LLC CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 52438-016_af9ba4d6-2bac-4862-8142-1d35f08226eb 52438-016 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205766 Linde LLC NITROGEN 995 mL/L N 20181231 52454-001_10b9f509-093e-453d-b032-bb1dd2f52c81 52454-001 HUMAN OTC DRUG Fonow Bacitracin, Neomycin, Polymyxin B, Lidocaine HCL OINTMENT TOPICAL 20180101 OTC MONOGRAPH FINAL part333B Zhejiang Reachall Pharmaceutical Co., Ltd. BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; LIDOCAINE 500; 3.5; 5000; 40 [iU]/g; mg/g; [iU]/g; mg/g N 20191231 52460-003_61924332-9de5-5d51-e053-2991aa0aba8c 52460-003 HUMAN OTC DRUG Business Elite Amenity SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20120916 OTC MONOGRAPH FINAL part355 Hangzhou Zhuwen Inflight & Travel Products Co., Ltd. SODIUM FLUORIDE 1.5 mg/g N 20191231 52471-100_44d74207-2e5b-47bd-87ac-aba45145fe40 52471-100 HUMAN OTC DRUG A and D plus E Petrolatum OINTMENT TOPICAL 20120514 OTC MONOGRAPH FINAL part347 H&H Laboratories, Inc. PETROLATUM 937.5 mg/g E 20171231 52471-101_41f08daa-55b1-42ac-b2e2-4a8dd8883536 52471-101 HUMAN OTC DRUG A and D Petrolatum OINTMENT TOPICAL 20120514 OTC MONOGRAPH FINAL part347 H&H Laboratories, Inc. PETROLATUM 937.5 mg/g E 20171231 52471-111_f251e7d4-222e-4e0f-9317-2e75bdaa86f2 52471-111 HUMAN OTC DRUG Sorbitol Sorbitol SOLUTION RECTAL 20130610 OTC MONOGRAPH NOT FINAL part334 H&H Laboratories, Inc. SORBITOL 1 g/mL E 20171231 52471-116_c1a05a5a-85a2-491e-812c-7ea8411669cf 52471-116 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20120503 OTC MONOGRAPH NOT FINAL part347 H&H Laboratories, Inc. ZINC OXIDE 200 mg/g E 20171231 52472-100_62d5fef4-108c-4279-aec5-ac0606054c72 52472-100 HUMAN PRESCRIPTION DRUG Oxygen, Refrigerated OXYGEN GAS RESPIRATORY (INHALATION) 20100707 UNAPPROVED MEDICAL GAS Breath of Life LLC OXYGEN 1 L/L E 20171231 52473-001_502d8daf-8b6f-4651-b0ae-08e205bcdf16 52473-001 HUMAN OTC DRUG Vanish Benzalkonium Chloride LIQUID TOPICAL 20100614 OTC MONOGRAPH NOT FINAL part333A Tinks BENZALKONIUM CHLORIDE .13 mL/100mL N 20181231 52473-010_9aaae807-122b-465f-98e8-6f25cfaf74fc 52473-010 HUMAN OTC DRUG Odorless Hand Sanitizer Foam Benzalkonium Chloride LIQUID TOPICAL 20100515 OTC MONOGRAPH NOT FINAL part333A Tinks BENZALKONIUM CHLORIDE .1 mL/100mL E 20171231 52481-2481_908f1758-48c5-48f3-9707-3326760a4142 52481-2481 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19770101 UNAPPROVED MEDICAL GAS Genesis Respiratory Services OXYGEN 99.9 L/100L N 20181231 52486-001_2ad05cb6-8664-3474-e054-00144ff88e88 52486-001 HUMAN OTC DRUG PARA-AID Povidone-Iodine Prep Pads Povidone Iodine IRRIGANT TOPICAL 20160202 OTC MONOGRAPH NOT FINAL part333A Mcure Health Solutions Inc. POVIDONE-IODINE 10 mg/mL E 20171231 52486-002_52e536c3-c626-2f46-e054-00144ff8d46c 52486-002 HUMAN OTC DRUG HOT PAIN RELIEF Capsaicin Patch PATCH TOPICAL 20170627 OTC MONOGRAPH NOT FINAL part348 MCURE HEALTH SOLUTIONS INC. CAPSAICIN 1.2 mg/1000mg N 20181231 52486-005_2651d84a-d1fd-25dd-e054-00144ff8d46c 52486-005 HUMAN OTC DRUG ICE COLD Analgesic MENTHOL CREAM TOPICAL 20151205 OTC MONOGRAPH NOT FINAL part348 MCure Health Solutions MENTHOL 2 mg/g N 20181231 52486-007_338f2e5d-cf67-5fac-e054-00144ff8d46c 52486-007 HUMAN OTC DRUG PARAID TRIPLE ANTIBIOTIC BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE OINTMENT TOPICAL 20160524 OTC MONOGRAPH FINAL part333B Mcure Health Solutions Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 U/g; mg/g; U/g N 20181231 52486-009_4e7965f2-09c2-6f9a-e054-00144ff8d46c 52486-009 HUMAN OTC DRUG Paraid Sterile Alcohol Prep Pads ISOPROPYL ALCOHOL SWAB TOPICAL 20160211 20190228 OTC MONOGRAPH NOT FINAL part333A MCure Health Solutions Inc ISOPROPYL ALCOHOL 70 g/100g N 20181231 52486-010_44bd9411-0c34-1729-e054-00144ff88e88 52486-010 HUMAN OTC DRUG Acne Treatment Clear Gel - Maximum Strength SALICYLIC ACID GEL TOPICAL 20150327 OTC MONOGRAPH FINAL part333D McCure Health Solutions Inc. SALICYLIC ACID 5 mg/g E 20171231 52486-012_44bd9411-0c55-1729-e054-00144ff88e88 52486-012 HUMAN OTC DRUG Vanishing Scent Muscle Rub Gel MENTHOL GEL TOPICAL 20150327 OTC MONOGRAPH NOT FINAL part348 McCure Health Solutions Inc. MENTHOL 25 mg/g E 20171231 52486-013_44bd9411-0c67-1729-e054-00144ff88e88 52486-013 HUMAN OTC DRUG Ultra Strength Pain Relief Balm CAMPHOR, MENTHOL GEL TOPICAL 20150327 OTC MONOGRAPH NOT FINAL part348 McCure Health Solutions Inc. CAMPHOR (NATURAL); MENTHOL 110; 110 mg/g; mg/g E 20171231 52486-018_6239fbca-8656-86c3-e053-2a91aa0ac19d 52486-018 HUMAN OTC DRUG PARA-AID ANTIBACTERIAL BANDAGE benzalkonium chloride swab SWAB TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part333A MCURE HEALTH SOLUTIONS INC. BENZALKONIUM CHLORIDE .12 mg/100mg N 20191231 52486-151_543b6f9c-35f8-19da-e054-00144ff8d46c 52486-151 HUMAN OTC DRUG STERILE ALCOHOL PREP PADS isopropyl alcohol swab SWAB TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part333A Mcure Health Solutions Inc. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 52486-152_543a7afa-7d57-597f-e054-00144ff88e88 52486-152 HUMAN OTC DRUG STERILE ALCOHOL PREP PADS isopropyl alcohol swab SWAB TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part333A Mcure Health Solutions Inc. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 52486-153_50ffb5ff-9b02-1f02-e054-00144ff8d46c 52486-153 HUMAN OTC DRUG STERILE ALCOHOL PREP PADS isopropyl alcohol swab SWAB TOPICAL 20170602 OTC MONOGRAPH NOT FINAL part333A Mcure Health Solutions Inc. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 52486-170_4d9da7b1-7631-0684-e054-00144ff88e88 52486-170 HUMAN OTC DRUG isopropyl alcohol swab PARA-AID STERILE ALCOHOL PREP PADS SWAB TOPICAL 20170420 OTC MONOGRAPH NOT FINAL part333A Mcure Health Solutions Inc. ISOPROPYL ALCOHOL 70 g/100g N 20181231 52486-200_6145267e-9ad5-23ed-e053-2991aa0a9593 52486-200 HUMAN OTC DRUG Babys Butt Care Diaper Rash ZINC OXIDE CREAM TOPICAL 20150113 OTC MONOGRAPH FINAL part347 Mcure Health Solutions Inc. ZINC OXIDE 16 g/100g N 20181231 52486-320_4b2d92e8-5649-1c21-e054-00144ff8d46c 52486-320 HUMAN OTC DRUG ULTRA STRENGTH PAIN RELIEF BALM Camphor Menthol Ointment OINTMENT TOPICAL 20170320 OTC MONOGRAPH NOT FINAL part348 MCURE HEALTH SOLUTIONS MENTHOL; CAMPHOR (SYNTHETIC) 11; 11 g/100g; g/100g N 20181231 52486-500_2fd6d118-350a-498b-e054-00144ff88e88 52486-500 HUMAN OTC DRUG EYE WASH EYE WASH LIQUID OPHTHALMIC 20160407 OTC MONOGRAPH FINAL part349 MCURE HEALTH SOLUTIONS INC. WATER 99.1 mL/100mL E 20171231 52490-100_d120f92e-5df5-4cde-a1ab-ff8c0eb77884 52490-100 HUMAN OTC DRUG B4 Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333A Midway Advanced Products, LLC ALCOHOL 42 mg/25mL N 20181231 52490-200_079c7c82-6400-432b-8bc4-bd2133baab07 52490-200 HUMAN OTC DRUG KNOCKOUT HAND SANITIZER Alcohol SOLUTION PERCUTANEOUS 20110801 OTC MONOGRAPH NOT FINAL part333E Midway Advanced Products, LLC ALCOHOL 42 mg/25mL E 20171231 52490-500_5186af92-f09d-67cc-e054-00144ff8d46c 52490-500 HUMAN OTC DRUG b4 Antiseptic Hand Sanitizer Benzalkonium Chloride 0.13% BENZALKONIUM CHLORIDE GEL TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part333E Midway Advanced Products LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 52490-500_5da5407d-903f-9430-e053-2a91aa0af73b 52490-500 HUMAN OTC DRUG b4 Antiseptic Hand Sanitizer Benzalkonium Chloride 0.13% BENZALKONIUM CHLORIDE GEL TOPICAL 20171110 OTC MONOGRAPH NOT FINAL part333E Midway Advanced Products LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 52512-130_1ce5f34a-abc9-4ea8-b654-407ecf954440 52512-130 HUMAN OTC DRUG Dr. Numb Lidocaine CREAM TOPICAL 20121115 OTC MONOGRAPH FINAL part348 Ei Inc. LIDOCAINE 5 g/100g E 20171231 52512-161_794ec692-f58c-4efd-b341-9b86ae3449f8 52512-161 HUMAN OTC DRUG Cold-EEZE cherry Zinc Gluconate SPRAY TOPICAL 20110801 20190331 UNAPPROVED HOMEOPATHIC Ei Inc. ZINC GLUCONATE 2 [hp_X]/.5mL E 20171231 52512-162_794ec692-f58c-4efd-b341-9b86ae3449f8 52512-162 HUMAN OTC DRUG Cold-EEZE mint Zinc Gluconate SPRAY TOPICAL 20110801 20190331 UNAPPROVED HOMEOPATHIC Ei Inc. ZINC GLUCONATE 2 [hp_X]/.5mL E 20171231 52512-501_7ff2929c-7264-4fb1-bdcf-901a0f729fe6 52512-501 HUMAN OTC DRUG Dark Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Ei Inc. ZINC OXIDE; TITANIUM DIOXIDE 20; 7 g/100g; g/100g E 20171231 52533-001_2a80c18a-119b-4df9-a9d2-b9bf8038d900 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20111205 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52533-001_40d556c4-7ec7-4ea9-b9ff-75690f63010f 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20120413 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52533-001_68a9062a-a24b-4e53-a6f9-844bca6526fd 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20130408 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52533-001_a903817d-763b-4266-847a-dd3f79f4bdc6 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20100802 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52533-001_b15dc4f2-8639-49d4-8e21-98849b6a1f4f 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20131101 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52533-001_c576d88b-0088-4964-8c58-da175995e84a 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20130430 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52533-001_d5d8d014-7b4c-4ad9-abf0-2b586830b443 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20130425 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52533-001_f6707ab1-0bbd-47c1-b5bc-cddf60f5beb8 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20130628 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52533-001_fec562f9-7b6e-43d9-9a90-d3cf3f9f9e80 52533-001 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20120413 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52533-004_f6dde57f-87f2-4694-9d7d-5fd502fc3a87 52533-004 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140821 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-005_08860913-59ea-45da-ad52-3c89acfcea9f 52533-005 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20131011 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-005_d79919e1-bb86-4af3-8a93-0fd786aa2fd1 52533-005 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20120118 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-005_eb7e7756-68d1-4ecd-8420-18326aac3456 52533-005 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-008_706000cd-740e-41f3-b4ea-9455f3da5116 52533-008 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-008_c7a65ea5-de8a-443f-a963-f52bc3030976 52533-008 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140821 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-014_6748dba5-40e3-4da6-91a1-b6cf400ece74 52533-014 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium INJECTION, SOLUTION INTRAVENOUS 20111101 UNAPPROVED DRUG OTHER Cantrell Drug Company CEFAZOLIN SODIUM 2 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52533-025_0a6669a6-692d-4dd6-b9de-66b60e215983 52533-025 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20130130 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 20 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-025_0bcb131c-64da-4f83-bd06-15da9b4ece52 52533-025 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 20 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-025_c96e60ea-3961-42b4-805f-320321fb9eda 52533-025 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20140821 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 20 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-029_966f4240-7b5b-4015-a737-5d8cc77edb7c 52533-029 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20131122 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 30 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-034_dc956ab6-b338-4b27-8ae3-050bc5a7aef0 52533-034 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl INJECTION, SOLUTION INTRAVENOUS 20120223 UNAPPROVED DRUG OTHER Cantrell Drug Company LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 52533-042_389e438b-7e82-471a-af40-4196ed466866 52533-042 HUMAN PRESCRIPTION DRUG Meperidine HCl Meperidine HCl INJECTION, SOLUTION INTRAVENOUS 20131114 UNAPPROVED DRUG OTHER Cantrell Drug Company MEPERIDINE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-042_5803ba3e-9045-438b-a68b-5ff868855e45 52533-042 HUMAN PRESCRIPTION DRUG Meperidine HCl Meperidine HCl INJECTION, SOLUTION INTRAVENOUS 20120123 UNAPPROVED DRUG OTHER Cantrell Drug Company MEPERIDINE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-042_87c24197-277e-4620-90ff-3c624ed6010f 52533-042 HUMAN PRESCRIPTION DRUG Meperidine HCl Meperidine HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company MEPERIDINE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-042_e8104c2e-14b2-41e8-9050-f4f8664ad79a 52533-042 HUMAN PRESCRIPTION DRUG Meperidine HCl Meperidine HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company MEPERIDINE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-048_b9f98eaf-6261-49f5-81dc-e1c212bdb34f 52533-048 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20120730 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 10 [USP'U]/1000mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] E 20171231 52533-051_ecd8aa21-89cf-47e7-bb2f-5f1457e46602 52533-051 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 2 [USP'U]/100mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] E 20171231 52533-054_a7bd8a1a-594b-4c80-a4a0-0b720a728d53 52533-054 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 30 [USP'U]/500mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] E 20171231 52533-055_3b5b2071-da23-4d84-bdbe-02cf7a4afc6b 52533-055 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 30 [USP'U]/500mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] E 20171231 52533-056_0b37f72f-edf6-4195-ae82-b70e3413a008 52533-056 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 30 [USP'U]/500mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] E 20171231 52533-056_33dae4b1-7018-459f-a8fe-a6b0059e9445 52533-056 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20130425 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 15 [USP'U]/250mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] E 20171231 52533-059_6051d8f9-3e1e-4c78-a749-bd17f7618e41 52533-059 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20130501 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-069_fe72d408-9aca-4044-8a98-2bcbb395d85a 52533-069 HUMAN PRESCRIPTION DRUG Vancomycin HCl Vancomycin HCl INJECTION, SOLUTION INTRAVENOUS 20130501 UNAPPROVED DRUG OTHER Cantrell Drug Company VANCOMYCIN HYDROCHLORIDE 4.2 mg/mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 52533-070_14a0b6cb-af4d-42ef-96ff-52976a419aaf 52533-070 HUMAN PRESCRIPTION DRUG Vancomycin HCl Vancomycin HCl INJECTION, SOLUTION INTRAVENOUS 20120525 UNAPPROVED DRUG OTHER Cantrell Drug Company VANCOMYCIN HYDROCHLORIDE 5 mg/mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 52533-070_dce16bbc-4826-4a7f-843d-0f4f81bb6703 52533-070 HUMAN PRESCRIPTION DRUG Vancomycin HCl Vancomycin HCl INJECTION, SOLUTION INTRAVENOUS 20130830 UNAPPROVED DRUG OTHER Cantrell Drug Company VANCOMYCIN HYDROCHLORIDE 5 mg/mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 52533-071_f6e055c7-1f22-4506-bd1e-6dc2eb793aa2 52533-071 HUMAN PRESCRIPTION DRUG Vancomycin HCl Vancomycin HCl INJECTION, SOLUTION INTRAVENOUS 20120525 UNAPPROVED DRUG OTHER Cantrell Drug Company VANCOMYCIN HYDROCHLORIDE 6 mg/mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 52533-074_7ade28d7-cb42-4daf-bea8-9bcce175c477 52533-074 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-074_7b06e0a7-2433-46d6-86a7-9e28d31c7e9c 52533-074 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-074_d4c18576-18ff-46c1-99fa-8b88ef32b86e 52533-074 HUMAN PRESCRIPTION DRUG Fentanyl Citrate Fentanyl Citrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111020 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 50 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-080_10c0befd-7161-4f4c-9a5c-ebf2422d33aa 52533-080 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20130917 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE; BUPIVACAINE HYDROCHLORIDE 2; 1.25 ug/mL; mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII E 20171231 52533-080_3b56263f-62bd-4571-84d6-83b2930ff721 52533-080 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20140625 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE; BUPIVACAINE HYDROCHLORIDE 2; 1.25 ug/mL; mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII E 20171231 52533-080_c2d97900-1e9f-46cf-b5c7-773da45f87e2 52533-080 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20120816 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE; BUPIVACAINE HYDROCHLORIDE 2; 1.25 ug/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-080_f3254ff6-b17a-4687-b8c2-3bff073b440e 52533-080 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20130325 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE; BUPIVACAINE HYDROCHLORIDE 2; 1.25 ug/mL; mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII E 20171231 52533-081_56079bf1-a667-48e7-9392-85166d7aff21 52533-081 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20131218 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE; BUPIVACAINE HYDROCHLORIDE 3; 1.25 ug/mL; mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII E 20171231 52533-096_f9e573f1-53bc-4cb8-82ed-d7ee761970ca 52533-096 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20110218 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 5 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-097_f1d5d88f-1693-48cf-b24c-450b2a707ff8 52533-097 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120509 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 5 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-098_7938e6ac-68cd-41cb-b4e7-d53b1c624b7b 52533-098 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20110630 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 10 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-098_b38b891d-46df-45bc-8bf2-fbb2172d1738 52533-098 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20121026 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 10 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-099_6ff3505e-13ea-4bc8-a709-66b133c5a261 52533-099 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION, SOLUTION INTRAVENOUS 20110221 UNAPPROVED DRUG OTHER Cantrell Drug Company MAGNESIUM SULFATE 20 g/500mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 52533-100_7894bb13-6e10-466e-83a9-9d0f8126bbb4 52533-100 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20110222 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 1 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-101_10eea951-d568-45fe-8ab3-1450fda1a64c 52533-101 HUMAN PRESCRIPTION DRUG Amiodarone HCl Amiodarone HCl INJECTION, SOLUTION INTRAVENOUS 20110801 UNAPPROVED DRUG OTHER Cantrell Drug Company AMIODARONE HYDROCHLORIDE 1.8 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 52533-101_52c3ce04-e1b7-4cde-b0d8-c716612a0a41 52533-101 HUMAN PRESCRIPTION DRUG Amiodarone HCl Amiodarone HCl INJECTION, SOLUTION INTRAVENOUS 20131018 UNAPPROVED DRUG OTHER Cantrell Drug Company AMIODARONE HYDROCHLORIDE 1.8 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 52533-102_3219848d-81a3-46ba-b18d-49c7343e0ec0 52533-102 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION, SOLUTION INTRAVENOUS 20110308 UNAPPROVED DRUG OTHER Cantrell Drug Company CALCIUM CHLORIDE 20 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 52533-104_d79d1eb4-bd87-4879-aa42-c571f2040ccb 52533-104 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20111107 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 10 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-105_5219e93f-e249-44ee-b692-92f3e76b3d26 52533-105 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20121112 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 2 [USP'U]/100mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] E 20171231 52533-106_3324ca48-b7cc-474c-b14f-d156de08d340 52533-106 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120809 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 50 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-107_ba5bedcd-2ba7-44f4-a92b-8fcac6eaed03 52533-107 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION, SOLUTION INTRAVENOUS 20110725 UNAPPROVED DRUG OTHER Cantrell Drug Company MAGNESIUM SULFATE 20 g/250mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 52533-110_6c541794-62cf-4de8-8bb4-b6402f0abd33 52533-110 HUMAN PRESCRIPTION DRUG Phenylephrine HCl Phenylephrine HCl INJECTION, SOLUTION INTRAVENOUS 20110630 UNAPPROVED DRUG OTHER Cantrell Drug Company PHENYLEPHRINE HYDROCHLORIDE 160 ug/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] E 20171231 52533-113_2fef8fc4-264f-4548-8f5a-74eba7201b62 52533-113 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium INJECTION, SOLUTION INTRAVENOUS 20131205 UNAPPROVED DRUG OTHER Cantrell Drug Company CEFAZOLIN SODIUM 30 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52533-120_40005224-6df3-46be-be19-9b71eb80271a 52533-120 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium INJECTION, SOLUTION INTRAVENOUS 20131011 UNAPPROVED DRUG OTHER Cantrell Drug Company CEFAZOLIN SODIUM 100 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52533-120_b533ef7c-0c75-4de4-a316-81e4a937b98a 52533-120 HUMAN PRESCRIPTION DRUG Cefazolin Sodium Cefazolin Sodium INJECTION, SOLUTION INTRAVENOUS 20131114 UNAPPROVED DRUG OTHER Cantrell Drug Company CEFAZOLIN SODIUM 100 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52533-125_13b971d5-b59b-4d8c-b891-533b495f3faf 52533-125 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120509 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 4 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-130_13b5d9dc-b935-467f-8b64-e42d4784eb05 52533-130 HUMAN PRESCRIPTION DRUG Phenylephrine HCl Phenylephrine HCl INJECTION, SOLUTION INTRAVENOUS 20131025 UNAPPROVED DRUG OTHER Cantrell Drug Company PHENYLEPHRINE HYDROCHLORIDE 300 ug/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] E 20171231 52533-132_372c9693-0219-4f02-bcc3-cc9f68ab38e5 52533-132 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAVENOUS 20131025 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-137_08a7f8c9-bfd8-42cb-a1c6-27124ab0cc94 52533-137 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRATHECAL; INTRAVENOUS 20120123 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE .5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-138_70b5656c-8fe5-4474-a6fd-e6e4be49a644 52533-138 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120829 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 2 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-142_06a6c4e5-41c6-41af-bfe1-520f7e0e9420 52533-142 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120829 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 100 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-145_9c8fc8c2-e932-4243-9169-d77a301611c8 52533-145 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-145_b116c32b-06ed-49f3-87cd-06aaf382cf01 52533-145 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE .4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-146_bf7c3e88-496f-4863-b94b-ba7d6027b6c7 52533-146 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140813 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-146_c746ac99-67f5-4392-a757-763d639b6659 52533-146 HUMAN PRESCRIPTION DRUG Hydromorphone HCl Hydromorphone HCl INJECTION, SOLUTION INTRAVENOUS 20140820 UNAPPROVED DRUG OTHER Cantrell Drug Company HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-147_88997fd5-96d7-43fc-9578-ea03f2a1b4da 52533-147 HUMAN PRESCRIPTION DRUG Phenylephrine HCl Phenylephrine HCl INJECTION, SOLUTION INTRAVENOUS 20120615 UNAPPROVED DRUG OTHER Cantrell Drug Company PHENYLEPHRINE HYDROCHLORIDE 40 ug/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] E 20171231 52533-148_85b3652b-5081-48eb-beac-25e7b80ea9cf 52533-148 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20120322 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM .5 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-157_350effd7-cee9-489f-8cd1-3fc743ad5cdc 52533-157 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20140903 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE .5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52533-157_3575bf68-e932-4198-bdb7-038b4f11801d 52533-157 HUMAN PRESCRIPTION DRUG Midazolam HCl Midazolam HCl INJECTION, SOLUTION INTRAVENOUS 20130130 UNAPPROVED DRUG OTHER Cantrell Drug Company MIDAZOLAM HYDROCHLORIDE .5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52533-161_a018a9d3-08f8-458f-868d-a0df132a30be 52533-161 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION EPIDURAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120222 UNAPPROVED DRUG OTHER Cantrell Drug Company MORPHINE SULFATE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-164_5a29af4c-a60f-4c60-8048-5ca1a689b091 52533-164 HUMAN PRESCRIPTION DRUG Norepinephrine Bitartrate Norepinephrine Bitartrate INJECTION, SOLUTION INTRAVENOUS 20150312 UNAPPROVED DRUG OTHER Cantrell Drug Company NOREPINEPHRINE BITARTRATE 64 ug/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 52533-165_e80698f9-c85c-43cf-a387-d9aa2d509a38 52533-165 HUMAN PRESCRIPTION DRUG Norepinephrine Bitartrate Norepinephrine Bitartrate INJECTION, SOLUTION INTRAVENOUS 20150306 UNAPPROVED DRUG OTHER Cantrell Drug Company NOREPINEPHRINE BITARTRATE 16 ug/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 52533-166_6dda258a-0665-4eb5-a422-cf4d2240f4f1 52533-166 HUMAN PRESCRIPTION DRUG Norepinephrine Bitartrate Norepinephrine Bitartrate INJECTION, SOLUTION INTRAVENOUS 20150306 UNAPPROVED DRUG OTHER Cantrell Drug Company NOREPINEPHRINE BITARTRATE 32 ug/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 52533-170_494203c0-7b4f-474f-9582-048d148d65f4 52533-170 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20110701 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 30 [USP'U]/500mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] E 20171231 52533-172_24f07811-6f00-4d0c-8fe1-74ffbc17e404 52533-172 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION, SOLUTION INTRAVENOUS 20140611 UNAPPROVED DRUG OTHER Cantrell Drug Company FAMOTIDINE 2 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 52533-174_8189e6af-318f-421c-903f-d0c85b7292ba 52533-174 HUMAN PRESCRIPTION DRUG Fentanyl Citrate, Bupivacaine HCl Fentanyl Citrate, Bupivacaine HCl INJECTION, SOLUTION EPIDURAL 20130812 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE; BUPIVACAINE HYDROCHLORIDE 1; 1.25 ug/mL; mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] CII E 20171231 52533-177_af37d776-18c2-4733-8673-1d758fee1d6b 52533-177 HUMAN PRESCRIPTION DRUG Promethazine HCl Promethazine HCl INJECTION, SOLUTION INTRAVENOUS 20140529 UNAPPROVED DRUG OTHER Cantrell Drug Company PROMETHAZINE HYDROCHLORIDE .5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 52533-179_10f49437-e628-4575-aa90-7af9191118b9 52533-179 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20150515 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 100 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-198_8f570223-fe5c-4dca-9730-cc59b2b97e39 52533-198 HUMAN PRESCRIPTION DRUG Diltiazem HCl Diltiazem HCl INJECTION, SOLUTION INTRAVENOUS 20131022 UNAPPROVED DRUG OTHER Cantrell Drug Company DILTIAZEM HYDROCHLORIDE .83 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 52533-204_40c4811d-3088-40ee-9c7b-beb57813276d 52533-204 HUMAN PRESCRIPTION DRUG Promethazine HCl Promethazine HCl INJECTION, SOLUTION INTRAVENOUS 20140527 UNAPPROVED DRUG OTHER Cantrell Drug Company PROMETHAZINE HYDROCHLORIDE .625 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 52533-211_36acde31-b65c-4648-8fed-5bfb41a89806 52533-211 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20121113 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 4 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-214_f62ee14d-24eb-4eb0-9866-c88d9026f7fc 52533-214 HUMAN PRESCRIPTION DRUG FENTANYL CITRATE Fentanyl Citrate INJECTION, SOLUTION INTRAVENOUS 20131122 UNAPPROVED DRUG OTHER Cantrell Drug Company FENTANYL CITRATE 5 ug/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52533-215_f80df7a0-ec3e-4736-bfe3-fddaddae0812 52533-215 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20140408 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 40 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-216_b85145ea-46ad-49da-bf4e-641316e7fcaa 52533-216 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS 20121221 UNAPPROVED DRUG OTHER Cantrell Drug Company HEPARIN SODIUM 50 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 52533-233_fac9b6cd-fe04-4c77-be27-60a3abc7a9e7 52533-233 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20160318 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 20 [USP'U]/500mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] E 20171231 52533-234_d7c0695e-70ad-4a5c-b2a3-55834bab1f1a 52533-234 HUMAN PRESCRIPTION DRUG Oxytocin Oxytocin INJECTION, SOLUTION INTRAVENOUS 20160318 UNAPPROVED DRUG OTHER Cantrell Drug Company OXYTOCIN 30 [USP'U]/1000mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] E 20171231 52536-134_a3be7ce7-f431-4c5a-80f7-f66fb4097091 52536-134 HUMAN PRESCRIPTION DRUG Erythromycin Ethylsuccinate Erythromycin Ethylsuccinate GRANULE, FOR SUSPENSION ORAL 20160928 NDA NDA050207 Wilshire Pharmaceuticals Inc. ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 52536-136_a3be7ce7-f431-4c5a-80f7-f66fb4097091 52536-136 HUMAN PRESCRIPTION DRUG Erythromycin Ethylsuccinate Erythromycin Ethylsuccinate GRANULE, FOR SUSPENSION ORAL 20160928 NDA NDA050207 Wilshire Pharmaceuticals Inc. ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 52536-162_0154b28d-3c1a-4a48-8a79-a2970fc52273 52536-162 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20170115 ANDA ANDA205973 Wilshire Pharmaceuticals, Inc. PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 52536-164_0154b28d-3c1a-4a48-8a79-a2970fc52273 52536-164 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20170115 ANDA ANDA205973 Wilshire Pharmaceuticals, Inc. PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 52536-168_0154b28d-3c1a-4a48-8a79-a2970fc52273 52536-168 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20170115 ANDA ANDA205973 Wilshire Pharmaceuticals, Inc. PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 52536-170_0154b28d-3c1a-4a48-8a79-a2970fc52273 52536-170 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20170115 ANDA ANDA205973 Wilshire Pharmaceuticals, Inc. PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 52536-250_a38b856e-018d-4949-83b3-73cbd327ce92 52536-250 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140317 20180430 ANDA ANDA202887 Wilshire Pharmaceuticals, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 52536-251_a38b856e-018d-4949-83b3-73cbd327ce92 52536-251 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140317 20180430 ANDA ANDA202887 Wilshire Pharmaceuticals, Inc. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 52536-252_a38b856e-018d-4949-83b3-73cbd327ce92 52536-252 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140317 20180531 ANDA ANDA202887 Wilshire Pharmaceuticals, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 52536-253_a38b856e-018d-4949-83b3-73cbd327ce92 52536-253 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140317 20180531 ANDA ANDA202887 Wilshire Pharmaceuticals, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 52536-300_65095eb5-f956-494a-8dee-02f2f3dc4f65 52536-300 HUMAN PRESCRIPTION DRUG Nitroglycerin Lingual nitroglycerin SPRAY, METERED SUBLINGUAL 20110201 20180228 NDA NDA018705 Wilshire Pharmaceuticals, Inc. NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 52536-500_d56bbbf6-d41b-4d18-b457-acaa24b0d8c1 52536-500 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate TABLET ORAL 20120716 ANDA ANDA090533 Wilshire Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 52536-510_d56bbbf6-d41b-4d18-b457-acaa24b0d8c1 52536-510 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate TABLET ORAL 20120720 ANDA ANDA090533 Wilshire Pharmaceuticals, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 52536-682_4cc74305-b64a-407f-bc7f-e58d8e20d031 52536-682 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20170215 ANDA ANDA205126 Wilshire Pharmaceuticals, Inc. CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 52536-688_4cc74305-b64a-407f-bc7f-e58d8e20d031 52536-688 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20170215 ANDA ANDA205126 Wilshire Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 52544-011_24e18548-f176-4ac7-a80d-3308d3df412d 52544-011 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 52544-032_24e18548-f176-4ac7-a80d-3308d3df412d 52544-032 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 52544-035_51416e17-7062-4927-af6e-3201e689b5de 52544-035 HUMAN PRESCRIPTION DRUG LILETTA Levonorgestrel INTRAUTERINE DEVICE INTRAUTERINE 20150226 NDA NDA206229 Actavis Pharma, Inc. LEVONORGESTREL 52 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] N 20181231 52544-039_24e18548-f176-4ac7-a80d-3308d3df412d 52544-039 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20120507 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 52544-044_81596585-b7ba-466b-b083-db270ada2db0 52544-044 HUMAN PRESCRIPTION DRUG Cordran Flurandrenolide TAPE TOPICAL 19690729 NDA NDA016455 Actavis Pharma, Inc. FLURANDRENOLIDE 4 ug/cm2 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 52544-045_6352d35d-98cf-4674-9810-b9e485f25ef0 52544-045 HUMAN PRESCRIPTION DRUG Condylox podofilox GEL TOPICAL 19970313 NDA NDA020529 Actavis Pharma, Inc. PODOFILOX 5 mg/g Decreased Mitosis [PE] N 20181231 52544-046_492b4a1e-a316-42ab-897d-cea32a1bf484 52544-046 HUMAN PRESCRIPTION DRUG Condylox podofilox SOLUTION TOPICAL 19901213 NDA NDA019795 Actavis Pharma, Inc. PODOFILOX 5 mg/mL Decreased Mitosis [PE] N 20181231 52544-052_24e18548-f176-4ac7-a80d-3308d3df412d 52544-052 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 52544-054_d2bc24bf-f393-4c3b-901c-a616689c6330 52544-054 HUMAN PRESCRIPTION DRUG Tilia Fe Norethindrone Acetate and Ethinyl Estradiol KIT ORAL 20050419 NDA NDA020130 Actavis Pharma, Inc. N 20181231 52544-058_068d36bf-2c22-4298-a74e-4993469a88ff 52544-058 HUMAN PRESCRIPTION DRUG Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20170316 NDA AUTHORIZED GENERIC NDA203667 Actavis Pharma, Inc. N 20181231 52544-063_24e18548-f176-4ac7-a80d-3308d3df412d 52544-063 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 52544-064_df48867f-93b4-4590-8ee3-cc01783c8860 52544-064 HUMAN PRESCRIPTION DRUG Layolis Fe norethindrone, ethinyl estradiol, and ferrous fumarate KIT ORAL 20111223 NDA NDA022573 Actavis Pharma, Inc. N 20181231 52544-065_78e08aad-8350-4a74-afd1-8a3a7cf1bb31 52544-065 HUMAN OTC DRUG Next Choice One Dose Levonorgestrel TABLET ORAL 20140512 20180330 ANDA ANDA200670 Actavis Pharma, Inc. LEVONORGESTREL 1.5 mg/1 N 20181231 52544-071_59712c78-a7a0-4499-b95e-3ebad1a86833 52544-071 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitatrate and Acetaminophen TABLET ORAL 20160501 ANDA ANDA040148 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 52544-076_bbbdb900-ed04-4bfa-88b3-894b4a76e22b 52544-076 HUMAN PRESCRIPTION DRUG Androderm Testosterone PATCH TRANSDERMAL 19950929 NDA NDA020489 Actavis Pharma, Inc. TESTOSTERONE 2 mg/d Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 52544-077_bbbdb900-ed04-4bfa-88b3-894b4a76e22b 52544-077 HUMAN PRESCRIPTION DRUG Androderm Testosterone PATCH TRANSDERMAL 19950929 NDA NDA020489 Actavis Pharma, Inc. TESTOSTERONE 4 mg/d Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 52544-079_37cd0262-993b-4e58-bb05-b7dfc18369ce 52544-079 HUMAN PRESCRIPTION DRUG PreQue 10 Prenatal Nutrition with CoQ10 and Lycopene TABLET ORAL 20111101 UNAPPROVED DRUG OTHER Actavis Pharma, Inc. VITAMIN A; ASCORBIC ACID; THIAMINE; RIBOFLAVIN; CYANOCOBALAMIN; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; DOCUSATE SODIUM; FOLIC ACID; IRON PENTACARBONYL; CUPRIC OXIDE; MAGNESIUM OXIDE; SELENIUM; ZINC OXIDE; UBIDECARENONE; LYCOPENE; DOCONEXENT 1250; 30; 1; 1.7; 1; 120; 15; 25; .5; 15; 1; 10; 7.5; 12.5; 50; 5; 50 [iU]/1; mg/1; mg/1; mg/1; ug/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 52544-080_89c87d34-a8a2-4787-ae72-9bbdad729155 52544-080 HUMAN PRESCRIPTION DRUG Fioricet Butalbital, Acetaminophen, and Caffeine CAPSULE ORAL 20130729 ANDA ANDA040885 Actavis Pharma, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 300; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20191231 52544-082_5123f020-8307-41a4-b14d-c0267502707b 52544-082 HUMAN PRESCRIPTION DRUG Fioricet with Codeine Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20130729 ANDA ANDA076560 Watson Pharma, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE 50; 300; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 52544-084_1add3dbb-ba36-420a-9815-cea8e0220269 52544-084 HUMAN PRESCRIPTION DRUG GELNIQUE oxybutynin chloride GEL TRANSDERMAL 20090515 NDA NDA022204 Actavis Pharma, Inc. OXYBUTYNIN CHLORIDE 100 mg/g Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 52544-087_396c78ed-c2b5-4098-82d1-e81a331ea8a9 52544-087 HUMAN PRESCRIPTION DRUG TriNessa Lo norgestimate and ethinyl estradiol KIT 20151231 NDA NDA021241 Actavis Pharma, Inc. N 20181231 52544-092_02d5978a-ae60-48d9-9640-544ced251ce3 52544-092 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate KIT 20100311 NDA NDA022437 Actavis Pharma, Inc. N 20181231 52544-151_43977e12-80e8-45bc-b59b-19f851047ebb 52544-151 HUMAN PRESCRIPTION DRUG RAPAFLO silodosin CAPSULE ORAL 20090323 NDA NDA022206 Actavis Pharma, Inc. SILODOSIN 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 52544-152_43977e12-80e8-45bc-b59b-19f851047ebb 52544-152 HUMAN PRESCRIPTION DRUG RAPAFLO silodosin CAPSULE ORAL 20090323 NDA NDA022206 Actavis Pharma, Inc. SILODOSIN 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 52544-153_02d5978a-ae60-48d9-9640-544ced251ce3 52544-153 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INTRAMUSCULAR 20000615 NDA NDA020715 Actavis Pharma, Inc. TRIPTORELIN PAMOATE 3.75 mg/2mL Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] N 20181231 52544-154_02d5978a-ae60-48d9-9640-544ced251ce3 52544-154 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INTRAMUSCULAR 20010629 NDA NDA021288 Actavis Pharma, Inc. TRIPTORELIN PAMOATE 11.25 mg/2mL Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] N 20181231 52544-156_02d5978a-ae60-48d9-9640-544ced251ce3 52544-156 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INTRAMUSCULAR 20100311 NDA NDA022437 Actavis Pharma, Inc. TRIPTORELIN PAMOATE 22.5 mg/2mL Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] N 20181231 52544-157_f6a551a9-0ede-42f4-8d76-4b9d200b0b2a 52544-157 HUMAN PRESCRIPTION DRUG Nuvessa metronidazole GEL VAGINAL 20150101 NDA NDA205223 Actavis Pharma, Inc. METRONIDAZOLE 65 mg/5g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 52544-161_59712c78-a7a0-4499-b95e-3ebad1a86833 52544-161 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitatrate and Acetaminophen TABLET ORAL 20130312 ANDA ANDA040148 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 52544-162_59712c78-a7a0-4499-b95e-3ebad1a86833 52544-162 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitatrate and Acetaminophen TABLET ORAL 20130312 ANDA ANDA040148 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 52544-164_24e18548-f176-4ac7-a80d-3308d3df412d 52544-164 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 52544-165_b9b1f1ef-f90f-4b85-b806-f32be0dc12b0 52544-165 HUMAN PRESCRIPTION DRUG Necon 777 norethindrone and ethinyl estradiol KIT 20021207 NDA NDA018985 Actavis Pharma, Inc. N 20181231 52544-166_9b87a67d-bbce-4cae-b365-b36d96b0cc6b 52544-166 HUMAN OTC DRUG Oxytrol For Women oxybutynin PATCH TRANSDERMAL 20160101 NDA NDA202211 Actavis Pharma, Inc. OXYBUTYNIN 3.9 mg/d E 20171231 52544-167_f74a882d-7f32-4ed0-8297-e77a7a593c57 52544-167 HUMAN PRESCRIPTION DRUG Microgestin 24 Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20151112 20180930 NDA NDA021871 Actavis Pharma, Inc. N 20181231 52544-175_690f95b9-077c-4fdd-b9dc-74a278dc389a 52544-175 HUMAN PRESCRIPTION DRUG Tilia Fe Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate KIT 20071001 NDA NDA020130 Watson Pharma, Inc. E 20171231 52544-188_02d5978a-ae60-48d9-9640-544ced251ce3 52544-188 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate KIT 20010629 NDA NDA021288 Actavis Pharma, Inc. N 20181231 52544-189_02d5978a-ae60-48d9-9640-544ced251ce3 52544-189 HUMAN PRESCRIPTION DRUG Trelstar triptorelin pamoate KIT 20000615 NDA NDA020715 Actavis Pharma, Inc. N 20181231 52544-204_b009e5cc-c333-46f8-a045-4ac2bed47daa 52544-204 HUMAN PRESCRIPTION DRUG GENERESS Fe norethindrone and ethinyl estradiol and ferrous fumarate KIT ORAL 20111223 NDA NDA022573 Actavis Pharma, Inc. N 20181231 52544-211_24e18548-f176-4ac7-a80d-3308d3df412d 52544-211 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 52544-219_794a7110-5481-48a6-8102-6f6e09f3cfc4 52544-219 HUMAN PRESCRIPTION DRUG Leena Norethindrone and Ethinyl Estradiol KIT ORAL 20050112 NDA AUTHORIZED GENERIC NDA018977 Actavis Pharma, Inc. N 20181231 52544-220_24e18548-f176-4ac7-a80d-3308d3df412d 52544-220 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 52544-228_685a835d-6d41-4895-a3e5-a02e885dc2a0 52544-228 HUMAN PRESCRIPTION DRUG Amethia Lo levonorgestrel/ethinyl estradiol and ethinyl estradiol KIT 20111025 ANDA ANDA200407 Watson Pharma, Inc. E 20171231 52544-233_0e1f5ef0-4d36-4547-8c6b-2cd7e843b521 52544-233 HUMAN PRESCRIPTION DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20140912 NDA AUTHORIZED GENERIC NDA017355 Actavis Pharma, Inc. N 20181231 52544-235_e299e6ac-a1bb-4b6e-91ae-5ddd074a3d49 52544-235 HUMAN PRESCRIPTION DRUG Nor QD norethindrone TABLET ORAL 19730102 NDA NDA017060 Watson Pharma, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 52544-236_a68d6299-6a57-44db-832e-b63f0c2cf43d 52544-236 HUMAN PRESCRIPTION DRUG Jevantique Lo Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20151109 NDA NDA021065 Actavis Pharma, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL .5; 2.5 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 52544-245_2013cfa5-7b44-42d0-addd-4fc368d7e8d8 52544-245 HUMAN PRESCRIPTION DRUG Necon Norethindrone and Mestranol KIT 19671117 NDA NDA016659 Watson Pharma, Inc. N 20181231 52544-247_1747155c-f93e-4ecc-a755-0ac82989a470 52544-247 HUMAN PRESCRIPTION DRUG MonoNessa norgestimate and ethinyl estradiol KIT 20030101 NDA NDA019653 Actavis Pharma, Inc N 20181231 52544-248_1747155c-f93e-4ecc-a755-0ac82989a470 52544-248 HUMAN PRESCRIPTION DRUG TriNessa norgestimate and ethinyl estradiol KIT 20030211 NDA NDA019653 Actavis Pharma, Inc N 20181231 52544-249_0e1f5ef0-4d36-4547-8c6b-2cd7e843b521 52544-249 HUMAN PRESCRIPTION DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20140916 NDA AUTHORIZED GENERIC NDA017354 Actavis Pharma, Inc. N 20181231 52544-254_3730181f-3bea-4f88-8760-935ed87acc52 52544-254 HUMAN PRESCRIPTION DRUG Brevicon Norethindrone and ethinyl estradiol KIT 19760329 20180630 NDA NDA017743 Actavis Pharma, Inc. N 20181231 52544-255_d50bd8cc-d5e0-47d0-9bfb-db4a966a5522 52544-255 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 NDA NDA020701 Actavis Pharma, Inc. PROGESTERONE 45 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 52544-256_d50bd8cc-d5e0-47d0-9bfb-db4a966a5522 52544-256 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 NDA NDA020701 Actavis Pharma, Inc. PROGESTERONE 90 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 52544-259_3730181f-3bea-4f88-8760-935ed87acc52 52544-259 HUMAN PRESCRIPTION DRUG Norinyl Norethindrone and ethinyl estradiol KIT 19741227 20191031 NDA NDA017565 Actavis Pharma, Inc. N 20181231 52544-265_3730181f-3bea-4f88-8760-935ed87acc52 52544-265 HUMAN PRESCRIPTION DRUG Norinyl Norethindrone and Mestranol KIT 19671117 NDA NDA016659 Actavis Pharma, Inc. N 20181231 52544-268_3cc32883-01eb-4270-930a-751358f49b71 52544-268 HUMAN PRESCRIPTION DRUG Amethia levonorgestrel and ethinyl estradiol and ethinyl estradiol KIT 20110531 ANDA ANDA078834 Watson Pharma, Inc. E 20171231 52544-274_5ff17058-fd52-44fd-858b-86b5d3cce1cc 52544-274 HUMAN PRESCRIPTION DRUG Tri-Norinyl Norethindrone and Ethinyl Estradiol KIT ORAL 19840413 NDA NDA018977 Actavis Pharma, Inc. N 20181231 52544-276_0e1f5ef0-4d36-4547-8c6b-2cd7e843b521 52544-276 HUMAN PRESCRIPTION DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20140818 NDA AUTHORIZED GENERIC NDA017876 Actavis Pharma, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; .02 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 52544-279_a6b608fb-5c6e-4223-8229-2677cfd89208 52544-279 HUMAN PRESCRIPTION DRUG Levora Levonorgestrel and Ethinyl Estradiol KIT ORAL 19931213 ANDA ANDA073594 Watson Pharma, Inc. E 20171231 52544-283_d50bd8cc-d5e0-47d0-9bfb-db4a966a5522 52544-283 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 NDA NDA020701 Actavis Pharma, Inc. PROGESTERONE 45 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 52544-284_d50bd8cc-d5e0-47d0-9bfb-db4a966a5522 52544-284 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 NDA NDA020701 Actavis Pharma, Inc. PROGESTERONE 90 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 52544-290_0e1f5ef0-4d36-4547-8c6b-2cd7e843b521 52544-290 HUMAN PRESCRIPTION DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20140807 NDA AUTHORIZED GENERIC NDA017875 Actavis Pharma, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1.5; .03 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 52544-291_0fd08994-b1fe-41e5-986a-457e368c06d9 52544-291 HUMAN PRESCRIPTION DRUG Trivora Levonogestrel and Ethinyl Estradiol KIT ORAL 19971218 ANDA ANDA074538 Watson Pharma, Inc. E 20171231 52544-295_6659e3db-8703-42b3-b90a-cefecf64b7ed 52544-295 HUMAN PRESCRIPTION DRUG Amethyst Levonorgestrel and Ethinyl Estradiol TABLET ORAL 20110613 ANDA ANDA079218 Actavis Pharma, Inc. LEVONORGESTREL; ETHINYL ESTRADIOL 90; 20 ug/1; ug/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20191231 52544-298_6b47280c-69f1-41a0-8ca1-bdd1cd93aae3 52544-298 HUMAN PRESCRIPTION DRUG RAJANI Drospirenone, ethinyl estradiol, levomefolate calcium KIT 20161011 ANDA ANDA203593 Actavis Pharma, Inc. N 20181231 52544-384_69278ea2-f7ed-44ce-b7fa-789af296e5ae 52544-384 HUMAN PRESCRIPTION DRUG Zovia 1/50E-28 Ethynodiol Diacetate and Ethinyl Estradiol KIT 19951206 ANDA ANDA072723 Actavis Pharma, Inc. N 20181231 52544-471_13071bf3-ee99-475d-87c8-dffa2002c0c4 52544-471 HUMAN PRESCRIPTION DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL 19961220 NDA NDA020655 Actavis Pharma, Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 52544-472_13071bf3-ee99-475d-87c8-dffa2002c0c4 52544-472 HUMAN PRESCRIPTION DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL 19961220 NDA NDA020655 Actavis Pharma, Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 52544-473_13071bf3-ee99-475d-87c8-dffa2002c0c4 52544-473 HUMAN PRESCRIPTION DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL 19961220 NDA NDA020655 Actavis Pharma, Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 52544-475_de373e5a-0a5e-405c-9945-44828b4c7efb 52544-475 HUMAN PRESCRIPTION DRUG NEXT CHOICE levonorgestrel TABLET ORAL 20090721 ANDA ANDA078666 Watson Pharma, Inc. LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] E 20171231 52544-550_3f8487f0-25cb-4f34-93df-f18787ae5e0d 52544-550 HUMAN PRESCRIPTION DRUG Necon 0.5/35 Norethindrone and Ethinyl Estradiol Tablets KIT 19870129 ANDA ANDA070686 Actavis Pharma, Inc. N 20181231 52544-552_3f8487f0-25cb-4f34-93df-f18787ae5e0d 52544-552 HUMAN PRESCRIPTION DRUG NECON 1/35 Norethindrone and Ethinyl Estradiol KIT 19870129 ANDA ANDA070687 Actavis Pharma, Inc. N 20181231 52544-554_3f8487f0-25cb-4f34-93df-f18787ae5e0d 52544-554 HUMAN PRESCRIPTION DRUG Necon 10/11 Norethindrone and Ethinyl Estradiol Tablets KIT 19880401 ANDA ANDA071044 Actavis Pharma, Inc. N 20181231 52544-622_fc6f22dc-ae98-4435-9a03-ca02e3c2ad90 52544-622 HUMAN PRESCRIPTION DRUG Microzide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA NDA020504 Actavis Pharma, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 52544-629_cc586725-7f2a-4db4-832d-2f88a35e8d38 52544-629 HUMAN PRESCRIPTION DRUG Nora BE Norethindrone TABLET ORAL 20050512 NDA AUTHORIZED GENERIC NDA017060 Watson Pharma, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 52544-690_91d68de5-ce58-4718-8799-8937cc162f6b 52544-690 HUMAN PRESCRIPTION DRUG Matzim LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110328 ANDA ANDA077686 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 52544-691_91d68de5-ce58-4718-8799-8937cc162f6b 52544-691 HUMAN PRESCRIPTION DRUG Matzim LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110328 ANDA ANDA077686 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 52544-692_91d68de5-ce58-4718-8799-8937cc162f6b 52544-692 HUMAN PRESCRIPTION DRUG Matzim LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110328 ANDA ANDA077686 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 52544-693_91d68de5-ce58-4718-8799-8937cc162f6b 52544-693 HUMAN PRESCRIPTION DRUG Matzim LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110328 ANDA ANDA077686 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 52544-694_91d68de5-ce58-4718-8799-8937cc162f6b 52544-694 HUMAN PRESCRIPTION DRUG Matzim LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110328 ANDA ANDA077686 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 52544-695_91d68de5-ce58-4718-8799-8937cc162f6b 52544-695 HUMAN PRESCRIPTION DRUG Matzim LA Diltiazem Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110328 ANDA ANDA077686 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 52544-847_a7044011-f669-4f50-aa37-3d96338348cb 52544-847 HUMAN PRESCRIPTION DRUG Low-Ogestrel Norgestrel and Ethinyl Estradiol KIT 19990728 20180331 ANDA ANDA075288 Actavis Pharma, Inc. N 20181231 52544-848_3906ff58-5487-4b1d-baa5-f96242547bbc 52544-848 HUMAN PRESCRIPTION DRUG Ogestrel Norgestrel and Ethinyl Estradiol KIT 20000821 ANDA ANDA075406 Actavis Pharma, Inc. N 20181231 52544-884_13071bf3-ee99-475d-87c8-dffa2002c0c4 52544-884 HUMAN PRESCRIPTION DRUG Alora Estradiol Transdermal System PATCH TRANSDERMAL 20020405 NDA NDA020655 Actavis Pharma, Inc. ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 52544-892_39fcc6ae-06bb-45c9-8e17-9815f82f902d 52544-892 HUMAN PRESCRIPTION DRUG Jolivette NORETHINDRONE TABLET ORAL 20030301 NDA NDA016954 Actavis Pharma, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 52544-896_24e18548-f176-4ac7-a80d-3308d3df412d 52544-896 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Actavis Pharma, Inc. MORPHINE SULFATE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 52544-913_dc0ddb97-4360-4504-bc20-e4072c10a16b 52544-913 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitartate and Acetaminophen TABLET ORAL 19970625 20180824 ANDA ANDA040099 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 52544-920_5b15c52c-c499-4090-8751-703581c4d42b 52544-920 HUMAN PRESCRIPTION DRUG OXYTROL Oxybutynin PATCH TRANSDERMAL 20030226 NDA NDA021351 Actavis Pharma, Inc. OXYBUTYNIN 3.9 mg/d Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 52544-930_aa45a956-a2f2-49bd-a40a-56f1e2f6d99d 52544-930 HUMAN PRESCRIPTION DRUG Actigall Ursodiol CAPSULE ORAL 19871231 NDA NDA019594 Actavis Pharma, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 52544-931_aead060b-cb47-4163-a1d8-8829837f2952 52544-931 HUMAN PRESCRIPTION DRUG INFeD Iron Dextran INJECTION INTRAMUSCULAR; INTRAVENOUS 19740429 NDA NDA017441 Actavis Pharma, Inc. IRON DEXTRAN 50 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 52544-940_e53e6005-b8ce-44f1-ba32-f2691b4d59c0 52544-940 HUMAN PRESCRIPTION DRUG Azurette Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol KIT 20081229 ANDA ANDA076916 Watson Pharma, Inc. E 20171231 52544-949_6c5f37c4-34fe-4dba-8fae-43c274e23495 52544-949 HUMAN PRESCRIPTION DRUG Lutera Levonorgestrel and Ethinyl Estradiol KIT 20041118 ANDA ANDA076625 Watson Pharma, Inc. E 20171231 52544-953_c3183ba3-b146-4937-8602-a14b0f898dbf 52544-953 HUMAN PRESCRIPTION DRUG Zenchent Norethindrone and Ethinyl Estradiol KIT 20100722 ANDA ANDA078323 Watson Pharma, Inc. E 20171231 52544-954_65f2bbf9-0b62-4c26-8651-9c662b91fe4b 52544-954 HUMAN PRESCRIPTION DRUG Reclipsen Desogestrel and Ethinyl Estradiol KIT 20050801 ANDA ANDA076915 Actavis Pharma, Inc. E 20171231 52544-955_681e2be7-769d-4d8f-be64-8c7536e2d486 52544-955 HUMAN PRESCRIPTION DRUG Fiorinal Butalbital, Aspirin, and Caffeine CAPSULE ORAL 19760504 NDA NDA017534 Actavis Pharma, Inc. BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 52544-956_868370fc-e7f2-4b28-9a11-e0bac36def45 52544-956 HUMAN PRESCRIPTION DRUG Fiorinal with Codeine Butalbital, Aspirin, Caffeine, and Codeine Phosphate CAPSULE ORAL 19901026 NDA NDA019429 Actavis Pharma, Inc. CODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ASPIRIN 30; 50; 40; 325 mg/1; mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE] CIII N 20181231 52544-966_2b737cf9-f1f3-46c5-bcfe-7649e8b67dd4 52544-966 HUMAN PRESCRIPTION DRUG Quasense Levonorgestrel and Ethinyl Estradiol KIT 20060906 ANDA ANDA077101 Actavis Pharma, Inc. N 20181231 52544-967_92c9a1b4-2b71-421a-8fec-270de0ac2966 52544-967 HUMAN PRESCRIPTION DRUG Sronyx Levonorgestrel and Ethinyl Estradiol KIT 20060531 ANDA ANDA077681 Watson Pharma, Inc. E 20171231 52544-981_7e982cbe-80c5-4a16-8077-25bf915cb718 52544-981 HUMAN PRESCRIPTION DRUG Zarah Drospirenone and Ethinyl Estradiol KIT ORAL 20100907 ANDA ANDA090081 Watson Pharma, Inc. E 20171231 52544-982_664f5765-8e1a-4944-b5df-014d48cadacd 52544-982 HUMAN PRESCRIPTION DRUG Vestura Drospirenone and Ethinyl Estradiol KIT 20120203 ANDA ANDA078833 Actavis Pharma, Inc. N 20191231 52546-100_3d974640-6f53-730c-e054-00144ff8d46c 52546-100 HUMAN OTC DRUG Smith and Johnson Antibacterial TRICLOSAN LIQUID TOPICAL 20100621 OTC MONOGRAPH NOT FINAL part333A Allied International Corp TRICLOSAN 115 mg/100mL E 20171231 52546-110_f9685c0b-c691-438c-b1c3-73cb1348418d 52546-110 HUMAN OTC DRUG Smith and Johnson Antibacterial TRICLOSAN SOAP TOPICAL 20110519 OTC MONOGRAPH FINAL part333E Allied International Corp TRICLOSAN .115 mL/100mL E 20171231 52549-2106_5ce3ebe2-4297-4a70-b32f-cdd74c462e49 52549-2106 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Taro Pharmaceutical Industries, Ltd. CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 52549-4118_96620eda-0669-4a7b-96ac-40206379d659 52549-4118 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil CREAM TOPICAL 20100305 ANDA ANDA090368 Taro Pharmaceutical Industries Ltd. FLUOROURACIL 50 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 52549-4145_2f2c5005-250a-452f-a8d2-05a505a0fb27 52549-4145 HUMAN PRESCRIPTION DRUG Imiquimod Imiquimod CREAM TOPICAL 20110415 ANDA ANDA200173 Taro Pharmaceutical Industries Ltd. IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] N 20181231 52549-4147_a1a2d874-5b9c-4f21-bb21-8757f2468b2a 52549-4147 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20110523 ANDA ANDA200998 Taro Pharmaceutical Industries Ltd. MEPROBAMATE 200 mg/1 CIV N 20181231 52549-4148_a1a2d874-5b9c-4f21-bb21-8757f2468b2a 52549-4148 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20110523 ANDA ANDA200998 Taro Pharmaceutical Industries Ltd. MEPROBAMATE 400 mg/1 CIV N 20181231 52553-001_873511a4-3a3f-4e29-bdcc-2dceae8d3229 52553-001 HUMAN OTC DRUG Smart Sense Isopropyl Alcohol Wipes Alcohol Wipe CLOTH TOPICAL 20110801 OTC MONOGRAPH FINAL part344 US Nonwovens ISOPROPYL ALCOHOL .7 mL/mL E 20171231 52553-002_85ded830-f5aa-4b86-a876-4c0470efbc25 52553-002 HUMAN OTC DRUG SMART SENSE Hydrogen Peroxide Hydrogen Peroxide CLOTH TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A US Nonwovens HYDROGEN PEROXIDE .03 mL/mL E 20171231 52554-1001_ad7e144f-288c-4513-86f1-c9d82bd80359 52554-1001 HUMAN OTC DRUG MediSpa Sunblock sunblock zinc oxide CREAM TOPICAL 20100804 UNAPPROVED DRUG OTHER Universal Cosmetic Co., Ltd ZINC OXIDE; OCTINOXATE; ENZACAMENE; AVOBENZONE .05; .07; .03; .005 mL/mL; mL/mL; mL/mL; mL/mL E 20171231 52554-1111_5bec4efd-2512-e6e1-e053-2a91aa0af4df 52554-1111 HUMAN OTC DRUG Sunscreen 100 Titanium Dioxide CREAM TOPICAL 20171019 OTC MONOGRAPH NOT FINAL part352 CMS LAB Inc. TITANIUM DIOXIDE 1.26 g/50mL N 20181231 52554-1112_d7a17996-5508-41a4-9067-1dfe1b564551 52554-1112 HUMAN OTC DRUG Powerproof Sunscreen 100 Homosalate, Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 CMS LAB Inc. HOMOSALATE; OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 2.5; 2.5; 2; 1.45 g/50mL; 1/50mL; g/50mL; g/50mL N 20181231 52554-1113_a9796d5e-0551-4179-ac75-0b80088ab6b9 52554-1113 HUMAN OTC DRUG Intensive Cover Blemish Balm Ethylhexyl Methoxycinnamate, Titanium Dioxide, Ethylhexyl Salicylate, Zinc Oxide CREAM TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 CMS LAB Inc. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE 1.8; 1.2132; .6; .576 g/30mL; g/30mL; g/30mL; g/30mL N 20181231 52554-1115_63f41ca6-6c48-394c-e053-2991aa0a2b03 52554-1115 HUMAN OTC DRUG Laser Sunscreen 100 Octisalate, Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20180116 OTC MONOGRAPH NOT FINAL part352 CMS LAB Inc. OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE 1.75; 1.68; .8715; 2.625 g/35mL; g/35mL; g/35mL; g/35mL N 20191231 52554-2001_7dd4f01c-7789-46a4-8617-c0782e79ccdf 52554-2001 HUMAN OTC DRUG MediSpa SunSpray sunblock OCTINOXATE SPRAY TOPICAL 20100806 UNAPPROVED DRUG OTHER Universal Cosmetic Co., Ltd OCTINOXATE; ENZACAMENE; OCTOCRYLENE .075; .05; .01 mL/mL; mL/mL; mL/mL E 20171231 52554-3001_eed3377a-26c2-4e93-95c4-7f10712d90be 52554-3001 HUMAN OTC DRUG Laser Block 100 sunblock OCTINOXATE CREAM TOPICAL 20100804 UNAPPROVED DRUG OTHER Universal Cosmetic Co., Ltd OCTINOXATE; ZINC OXIDE; ENZACAMENE; TITANIUM DIOXIDE; AMILOXATE; AVOBENZONE .07; .05; .03; .02; .02; .005 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL; mL/mL E 20171231 52554-4001_d522a805-d802-47e6-add2-fa06428a062a 52554-4001 HUMAN OTC DRUG Derma Blemish Balm blemish balm adenosine CREAM TOPICAL 20100805 UNAPPROVED DRUG OTHER Universal Cosmetic Co., Ltd ADENOSINE; TITANIUM DIOXIDE; ARBUTIN .0004; .06; .02 mL/mL; mL/mL; mL/mL E 20171231 52554-5001_ec0c2126-a7fa-448e-8805-21b2da0de858 52554-5001 HUMAN OTC DRUG Laser Rejuvenation restoring damage skin adenosine CREAM TOPICAL 20100819 UNAPPROVED DRUG OTHER Universal Cosmetic Co., Ltd ADENOSINE; ACETYL HEXAPEPTIDE-3; CENTELLA ASIATICA .00004; .0001; .001 mL/mL; mL/mL; mL/mL E 20171231 52557-001_60f3b3f4-4491-6aa8-e053-2a91aa0a7928 52557-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100625 NDA NDA205767 Cornerstone Mecial Services - Midwest, LLC OXYGEN 99 L/L N 20181231 52557-103_dec8a153-656f-4dc9-a48b-107e8ca65e1b 52557-103 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100625 UNAPPROVED MEDICAL GAS CornerStone Medical Services-Midwest LLC OXYGEN .99 L/L E 20171231 52559-575_37fb3e69-4cd9-431e-bc00-3878f091565a 52559-575 HUMAN OTC DRUG Anchor Foaming Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part333E Anchor Supply Company BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 52559-576_10d46c68-6a44-44a1-bf7a-b357f2b8aec7 52559-576 HUMAN OTC DRUG Anchor Foaming Mango TRICLOSAN SOAP TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part333E Anchor Supply Company TRICLOSAN .003 mL/mL E 20171231 52563-001_60b51691-b43b-0694-e053-2991aa0a7a35 52563-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19760101 NDA NDA205849 T.W. Smith Corp. OXYGEN 99.9 L/L N 20181231 52564-308_0e201221-d807-4594-8c71-d329e260a59f 52564-308 HUMAN OTC DRUG Hot Stuff CAPSICUM OLEORESIN CREAM TOPICAL 20140625 OTC MONOGRAPH NOT FINAL part348 Mueller Sports Medicine LLC CAPSICUM OLEORESIN .0265 g/106g N 20181231 52564-312_7a021d4c-443b-4a92-ae44-1828c72c049a 52564-312 HUMAN OTC DRUG Muellergesic menthol and camphor (synthetic) CREAM TOPICAL 20140625 OTC MONOGRAPH NOT FINAL part348 Mueller Sports Medicine LLC MENTHOL; CAMPHOR (SYNTHETIC) 12.72; 6.3 g/106g; g/106g N 20181231 52564-330_28ca4810-0b8c-4219-b026-f2066f153706 52564-330 HUMAN OTC DRUG Mueller First Aid Antiseptic Benzalkonium chloride, Lidocaine hydrochloride SPRAY TOPICAL 20130816 OTC MONOGRAPH NOT FINAL part348 Mueller Sports Medicine, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; 2 g/100mL; g/100mL N 20181231 52564-340_f6019888-a8fe-4aa8-ad9d-0271b2ca1e82 52564-340 HUMAN OTC DRUG Mueller Super Suds Benzalkonium Chloride LOTION TOPICAL 20140523 OTC MONOGRAPH NOT FINAL part333A Mueller Sports Medicine, Inc. BENZALKONIUM CHLORIDE .13 mg/mL E 20171231 52564-460_6e5f407f-bc79-41cc-8dce-302fbb496e65 52564-460 HUMAN OTC DRUG Mueller Instant Hand Sanitizer alcohol LIQUID TOPICAL 20100205 OTC MONOGRAPH NOT FINAL part333E Mueller Sports Medicine, Inc. ALCOHOL 62 mL/100mL N 20181231 52565-002_9f9f8b6b-3f0c-fae4-12df-2cd8737f38a0 52565-002 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20150708 ANDA ANDA202769 Teligent Pharma, Inc. DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52565-008_aa2311ee-5958-4d8f-800d-38c6f14266db 52565-008 HUMAN PRESCRIPTION DRUG Lidocaine lidocaine OINTMENT TOPICAL 20170227 ANDA ANDA205318 Teligent Pharma, Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52565-009_d90ba209-b839-445d-931b-75292dade428 52565-009 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 20140318 ANDA ANDA204494 Teligent Pharma, Inc. LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52565-010_d6e6b280-c430-2686-81bc-e9b5ec851d99 52565-010 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide LOTION TOPICAL 20160708 ANDA ANDA204608 Teligent Pharma, Inc. TRIAMCINOLONE ACETONIDE .25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52565-011_bfcdfaac-0b55-b6dc-b5bd-a8da62478bf8 52565-011 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide LOTION TOPICAL 20160708 ANDA ANDA204606 Teligent Pharma, Inc. TRIAMCINOLONE ACETONIDE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52565-012_ffb02099-36f5-4d60-ddd6-2c8fef67c722 52565-012 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide SOLUTION TOPICAL 20121127 NDA AUTHORIZED GENERIC NDA015296 Teligent Pharma, Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52565-013_1e719f33-4bc4-4fce-b970-a55c9e3d1ffa 52565-013 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OINTMENT TOPICAL 20121227 NDA AUTHORIZED GENERIC NDA013960 IGI Labs, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52565-014_f9246dba-e233-3a17-cd9d-935c402b39d5 52565-014 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT TOPICAL 20160513 ANDA ANDA205373 Teligent Pharma, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52565-017_e453431a-5200-4f5f-ba2c-b4c25ac12c83 52565-017 HUMAN PRESCRIPTION DRUG Flurandrenolide Flurandrenolide OINTMENT TOPICAL 20161230 ANDA ANDA207851 Teligent Pharma, Inc. FLURANDRENOLIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52565-018_d549d1c7-b34b-4af3-a715-d7c00d3b7e6b 52565-018 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin Phosphate SOLUTION TOPICAL 20161230 ANDA ANDA206945 Teligent Pharma, Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 52565-019_77e33c17-1fb4-4b1b-8552-443b1fe4eead 52565-019 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate betamethasone dipropionate OINTMENT TOPICAL 20171030 ANDA ANDA206118 Teligent Pharma, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52565-020_c949d40a-3541-4af3-9a20-ef1527444dd0 52565-020 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide CREAM TOPICAL 20121228 NDA AUTHORIZED GENERIC NDA012787 IGI Labs, Inc. FLUOCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52565-022_b20ce842-82a8-49bd-9f79-1c3c601f883d 52565-022 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20130801 ANDA ANDA076574 Teligent Pharma, Inc. ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20191231 52565-027_414c0043-f201-4fa1-86d3-056bea3ca5bd 52565-027 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin SOLUTION TOPICAL 20171120 ANDA ANDA208100 Teligent Pharma, Inc. ERYTHROMYCIN 20 mg/mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 52565-030_18c61779-584c-afba-6fcd-fc361e7688ad 52565-030 HUMAN PRESCRIPTION DRUG Desoximetasone desoximetasone OINTMENT TOPICAL 20160225 ANDA ANDA208101 Teligent Pharma, Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52565-031_c949d40a-3541-4af3-9a20-ef1527444dd0 52565-031 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide CREAM TOPICAL 20140515 NDA AUTHORIZED GENERIC NDA012787 IGI Labs, Inc. FLUOCINOLONE ACETONIDE .1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52565-033_c399f6d6-f743-4b92-83fe-6581fa6fd0e3 52565-033 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin GEL TOPICAL 20170726 ANDA ANDA208154 Teligent Pharma, Inc. ERYTHROMYCIN 20 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 52565-042_f2dff5ec-580b-4fda-adb8-3580fcd174c1 52565-042 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide OINTMENT TOPICAL 20161230 ANDA ANDA208287 Teligent Pharma, Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52565-048_2d79fe4a-e9f2-4478-ae82-db0d2d947d75 52565-048 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT TOPICAL 20170303 ANDA ANDA208590 Teligent Pharma, Inc. TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52565-052_e7459055-c654-718b-a000-0c8be2ce8ef0 52565-052 HUMAN PRESCRIPTION DRUG Cefotan Cefotetan Disodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151001 NDA NDA050588 Teligent Pharma, Inc. CEFOTETAN DISODIUM 1 g/10mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52565-053_e7459055-c654-718b-a000-0c8be2ce8ef0 52565-053 HUMAN PRESCRIPTION DRUG CEFOTAN cefotetan disodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151001 NDA NDA050588 Teligent Pharma, Inc. CEFOTETAN DISODIUM 2 g/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52565-055_da2abcc9-ea93-6ba2-fca4-fa10af2e4ba6 52565-055 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate LOTION TOPICAL 20161129 ANDA ANDA208667 Teligent Pharma, Inc. CLOBETASOL PROPIONATE .05 mg/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52565-056_aec9692c-7e49-4aef-848d-11eba8751c28 52565-056 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 20170417 ANDA ANDA208848 Teligent Pharma, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52565-082_3bea1895-b97a-4154-872b-b410c6589ec8 52565-082 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate GEL TOPICAL 20170306 ANDA ANDA208881 Teligent Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52565-087_2fba5a07-187f-4b21-a961-2f567994c50f 52565-087 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate HYDROCORTISONE BUTYRATE LOTION TOPICAL 20171121 ANDA ANDA209556 Teligent Pharma, Inc. HYDROCORTISONE BUTYRATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52565-092_929603f7-08e3-40c7-a975-812944f5a4e8 52565-092 HUMAN PRESCRIPTION DRUG AquaMEPHYTON PHYTONADIONE INJECTION, EMULSION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20170525 NDA NDA012223 Teligent Pharma, Inc. PHYTONADIONE 2 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 52565-093_929603f7-08e3-40c7-a975-812944f5a4e8 52565-093 HUMAN PRESCRIPTION DRUG AquaMEPHYTON PHYTONADIONE INJECTION, EMULSION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20170525 NDA NDA012223 Teligent Pharma, Inc. PHYTONADIONE 10 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 52565-094_309980d3-3361-432d-999f-b51f9b161334 52565-094 HUMAN PRESCRIPTION DRUG Clobetasol Propionate (emollient) clobetasol propionate CREAM TOPICAL 20170821 ANDA ANDA209411 Teligent Pharma, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52565-096_3fe54dc0-fc84-4428-89ba-eaf09a317a88 52565-096 HUMAN PRESCRIPTION DRUG ZANTAC ranitidine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170118 NDA NDA019090 Teligent Pharma, Inc. RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 52565-101_2025df1c-75ac-4184-b0d8-73fb870ce2a4 52565-101 HUMAN PRESCRIPTION DRUG ZANTAC ranitidine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170118 NDA NDA019090 Teligent Pharma, Inc. RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 52565-102_2025df1c-75ac-4184-b0d8-73fb870ce2a4 52565-102 HUMAN PRESCRIPTION DRUG ZANTAC ranitidine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170118 NDA NDA019090 Teligent Pharma, Inc. RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 52568-001_8031d6df-fc3b-425f-8698-0ca0d8be57e5 52568-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19900101 NDA NDA205889 Crumpton Welding Supply & Equipment, Inc OXYGEN 99 L/100L N 20191231 52568-002_1d3eb2cb-0e01-4c63-ac71-1c465b2220aa 52568-002 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19900101 NDA NDA209989 Crumpton Welding Supply & Equipment, Inc NITROUS OXIDE 99 L/100L N 20191231 52568-006_e8215a98-29e1-42c2-bb22-9fb1481a197c 52568-006 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19900101 NDA NDA205891 Crumpton Welding Supply & Equipment, Inc NITROGEN 99 L/100L N 20191231 52568-007_3c568358-f5e8-4b6c-bdf1-bfe76c472a14 52568-007 HUMAN PRESCRIPTION DRUG AIR COMPRESSED AIR COMPRESSED GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Crumpton Welding Supply & Equipment, Inc OXYGEN 20 L/100L E 20171231 52579-1600_8b4b8fe1-a51d-4168-b673-dfc4647c1bcc 52579-1600 HUMAN PRESCRIPTION DRUG Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) tilmanocept KIT 20130313 NDA NDA202207 Navidea Biopharmaceuticals, Inc. N 20181231 52579-1604_8b4b8fe1-a51d-4168-b673-dfc4647c1bcc 52579-1604 HUMAN PRESCRIPTION DRUG Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) tilmanocept KIT 20161020 NDA NDA202207 Navidea Biopharmaceuticals, Inc. N 20181231 52584-002_6940c5b5-ad9a-4337-9918-0fa09d76187c 52584-002 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 52584-004_67fcf103-1f5f-4937-9845-045f410e882e 52584-004 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION ENDOTRACHEAL; INTRACARDIAC; INTRAVENOUS 20100801 NDA NDA020800 General Injectables & Vaccines, Inc EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 52584-007_29331096-d7b1-4789-a083-d118821b2a65 52584-007 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine INJECTION, SOLUTION INTRAMUSCULAR 20100301 ANDA ANDA087408 General Injectables & Vaccines, Inc HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 52584-010_0a62ac2a-7cb5-4d24-8337-eca4e2875c0b 52584-010 HUMAN PRESCRIPTION DRUG Gentamicin Gentamicin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100901 ANDA ANDA062366 General Injectables & Vaccines, Inc GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 52584-013_690f91ba-c99a-4b1e-a1cd-334e36a9cbc1 52584-013 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 20100901 ANDA ANDA086283 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52584-015_cadfa3bb-5b2d-4230-aa8a-08036626cb71 52584-015 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 20100801 ANDA ANDA086283 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52584-017_53bd9a5c-596a-4692-a48e-676f5f8d8657 52584-017 HUMAN PRESCRIPTION DRUG Esmolol Esmolol INJECTION INTRAVENOUS 20100401 NDA NDA019386 General Injectables & Vaccines, Inc ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 52584-023_5d31ed14-148e-482d-92e7-1527cc87ce95 52584-023 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110907 ANDA ANDA065226 General Injectables & Vaccines, Inc CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52584-024_15d3eeb9-822a-4035-a227-601e4f66b380 52584-024 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120412 ANDA ANDA062831 General Injectables & Vaccines, Inc CEFAZOLIN SODIUM 500 mg/500mg Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52584-025_8efb19d8-82e0-45db-8c86-62c916b23504 52584-025 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20111026 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc SODIUM CHLORIDE 234 mg/30mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 52584-026_f6c94a72-3e67-4f0a-bd5d-6b3b56979a1b 52584-026 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20111005 ANDA ANDA078076 General Injectables & Vaccines, Inc ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 52584-028_24746648-5492-44dc-bdb5-8bda7de65790 52584-028 HUMAN PRESCRIPTION DRUG Doxy 100 Doxycycline Hyclate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120222 ANDA ANDA062475 General Injectables & Vaccines, Inc DOXYCYCLINE HYCLATE 100 mg/10mL N 20181231 52584-029_942fc642-95b9-4337-b4bd-210b91d11492 52584-029 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120508 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ATROPINE SULFATE .4 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 52584-030_fbdc85e3-d5ea-4a5f-8b48-0e20b461b36e 52584-030 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 20120612 ANDA ANDA086283 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 52584-031_1403dbb2-8386-480b-8655-270ccf47f834 52584-031 HUMAN PRESCRIPTION DRUG Mannitol Mannitol INJECTION, SOLUTION INTRAVENOUS 20100801 ANDA ANDA016269 General Injectables & Vaccines, Inc MANNITOL 12.5 g/50mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] N 20181231 52584-032_bbb9035b-a5a2-4333-9f61-21a5150c2079 52584-032 HUMAN PRESCRIPTION DRUG Cyanocobalamin Cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR 20100301 ANDA ANDA080737 General Injectables & Vaccines, Inc CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 52584-034_40479b96-287d-48dc-87fe-a21a50a07e7a 52584-034 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 20120530 ANDA ANDA086283 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 52584-035_063183a4-8c00-4662-b5ce-1f2c04592406 52584-035 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride lidocaine hydrochloride JELLY TOPICAL 20120828 ANDA ANDA086283 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52584-037_64cd4954-7215-420c-8810-9ff88a0d2383 52584-037 HUMAN PRESCRIPTION DRUG KETALAR ketamine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20121017 NDA NDA016812 General Injectables & Vaccines, Inc KETAMINE HYDROCHLORIDE 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 52584-038_f139138b-a69e-4d15-9d9f-807e551e6e98 52584-038 HUMAN PRESCRIPTION DRUG KETAMINE HYDROCHLORIDE ketamine hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 20121011 ANDA ANDA074549 General Injectables & Vaccines, Inc KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 52584-039_8973fd76-d686-4f06-9091-ee6fb3db0506 52584-039 HUMAN PRESCRIPTION DRUG Solu-Medrol Methylprednisolone Sodium Succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100401 NDA NDA011856 General Injectables & Vaccines, Inc METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52584-040_537d7fc1-b418-4611-9be8-b39fb701c739 52584-040 HUMAN PRESCRIPTION DRUG KETAMINE HYDROCHLORIDE ketamine hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 20121016 ANDA ANDA074549 General Injectables & Vaccines, Inc KETAMINE HYDROCHLORIDE 100 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 52584-042_e121bd26-be95-4323-8861-99f628e544ae 52584-042 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine Bupivacaine Hydrochloride and Epinephrine INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100701 ANDA ANDA071165 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 52584-043_9f57b5ad-5b9c-4a8a-9989-02727fcf824c 52584-043 HUMAN PRESCRIPTION DRUG PHYTONADIONE phytonadione INJECTION, EMULSION PARENTERAL 20130213 ANDA ANDA083722 General Injectables & Vaccines, Inc PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 52584-044_26cd349b-e19b-4c8b-a10b-a67d024996c2 52584-044 HUMAN PRESCRIPTION DRUG ATROPINE SULFATE atropine sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20130919 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ATROPINE SULFATE 1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 52584-046_26a1939e-e878-4dd1-9e34-17e88f9e6135 52584-046 HUMAN PRESCRIPTION DRUG PHYTONADIONE phytonadione INJECTION, EMULSION PARENTERAL 20140106 ANDA ANDA083722 General Injectables & Vaccines, Inc PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] E 20171231 52584-047_c6637ce7-f493-4a76-b926-f493af036dee 52584-047 HUMAN PRESCRIPTION DRUG Solu-Medrol Methylprednisolone Sodium Succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100401 NDA NDA011856 General Injectables & Vaccines, Inc METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 52584-048_bfe1e825-76a9-4128-bcbb-48bea75d52a8 52584-048 HUMAN PRESCRIPTION DRUG Dobutamine Dobutamine Hydrochloride Injection INJECTION, SOLUTION INTRAVENOUS 20141110 ANDA ANDA074292 General Injectables and Vaccines, Inc. DOBUTAMINE HYDROCHLORIDE 12.5 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] N 20181231 52584-049_c8b137d6-df03-476f-b654-0f19a40195b4 52584-049 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride Esmolol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20150910 ANDA ANDA076474 General Injectables and Vaccines, Inc. ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 52584-050_d7a03e96-6bab-4066-98a6-88b205171159 52584-050 HUMAN PRESCRIPTION DRUG Cortrosyn Cortrosyn INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 20100301 NDA NDA016750 General Injectables & Vaccines, Inc COSYNTROPIN .25 mg/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] N 20181231 52584-052_4aadb95c-8da2-4feb-aac8-84121a1e741b 52584-052 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010301 ANDA ANDA075241 General Injectables & Vaccines, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 52584-055_a0b453d2-f15c-4464-a686-d503d06778e1 52584-055 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20171128 ANDA ANDA075243 General Injectables and Vaccines, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 52584-056_f939c9fd-a823-4d89-94f3-d59a55b83f26 52584-056 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20180108 ANDA ANDA075243 General Injectables and Vaccines, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 52584-062_3a9dfcb2-cabf-40e8-ab3f-58e2f9f8abd2 52584-062 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride Esmolol Hydrochloride INJECTION INTRAVENOUS 20100801 ANDA ANDA076323 General Injectables & Vaccines, Inc ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 52584-064_957a0a5e-a4bf-4ee0-bdd4-3f7401ee2f3c 52584-064 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150916 NDA NDA019316 General Injectables and Vaccines, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 52584-066_be0feb08-c95c-407a-9054-5ae27affee14 52584-066 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20100401 ANDA ANDA040078 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52584-073_d8dae6e5-599a-48e3-8383-c3930a30dee8 52584-073 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160718 ANDA ANDA204404 General Injectables and Vaccines, Inc. METHOCARBAMOL 100 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 52584-093_d0cdc095-f183-4e00-b78c-2196a8600977 52584-093 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20110218 ANDA ANDA076256 General Injectables & Vaccines, Inc. FLUMAZENIL 1 mg/10mL Benzodiazepine Antagonist [EPC] N 20181231 52584-100_b2eecebc-1d07-4a16-9b4d-d13ddfa141f3 52584-100 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170215 ANDA ANDA065303 General Injectables and Vaccines, Inc. CEFAZOLIN SODIUM 500 mg/2.2mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 52584-102_e15b2893-332d-435d-89d7-369c8b7689a9 52584-102 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 NDA NDA018667 General Injectables & Vaccines, Inc FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 52584-104_05a459dc-9c0c-4cc1-a2f7-808d314173d3 52584-104 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride Dopamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100801 NDA NDA018132 General Injectables & Vaccines, Inc DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 52584-115_73a44d40-71e0-4db0-885a-8f775b20ff2b 52584-115 HUMAN PRESCRIPTION DRUG Brevibloc Brevibloc INJECTION INTRAVENOUS 20100701 NDA NDA019386 General Injectables & Vaccines ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 52584-119_43dbb2cf-4673-416f-850d-8ffca5cfcd1b 52584-119 HUMAN PRESCRIPTION DRUG Tigan Trimethobenzamide Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 20100801 NDA NDA017530 General Injectables & Vaccines, Inc TRIMETHOBENZAMIDE HYDROCHLORIDE 100 mg/mL Antiemetic [EPC],Emesis Suppression [PE] E 20171231 52584-130_1fb91dae-bd82-4c2c-b375-8c0ab0633bdb 52584-130 HUMAN PRESCRIPTION DRUG Cyanocobalamin Cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR 20100701 ANDA ANDA080737 General Injectables & Vaccines, Inc CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 52584-135_0d73ada6-738a-425c-808c-ea53d2d3c28b 52584-135 HUMAN PRESCRIPTION DRUG AMPICILLIN ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130313 ANDA ANDA063146 General Injectables & Vaccines, Inc AMPICILLIN SODIUM 500 mg/500mg Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 52584-136_cc39afe1-22b7-461a-808d-2d325194427a 52584-136 HUMAN PRESCRIPTION DRUG AMPICILLIN ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130314 ANDA ANDA062772 General Injectables & Vaccines, Inc AMPICILLIN SODIUM 1 g/g Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 52584-137_319cb079-6c9a-4b28-8704-85e5b9618a58 52584-137 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100901 ANDA ANDA040302 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52584-142_9375a0d2-93a6-451d-9ddd-255eaf705bf0 52584-142 HUMAN PRESCRIPTION DRUG PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride INJECTION INTRAVENOUS 20130402 NDA NDA203826 General Injectables & Vaccines, Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] N 20181231 52584-144_e009cd54-7bbd-4b7f-ba20-7779e1c2e0d8 52584-144 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100901 ANDA ANDA070737 General Injectables & Vaccines, Inc VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 52584-158_403bc8af-a99c-4a88-95e0-594b666e8d5b 52584-158 HUMAN PRESCRIPTION DRUG Vitamin K1 Phytonadione INJECTION, EMULSION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100901 ANDA ANDA087955 General Injectables & Vaccines, Inc PHYTONADIONE 10 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 52584-159_618a3ce5-a2f0-496f-8587-dbcbea1406ee 52584-159 HUMAN PRESCRIPTION DRUG Adrenalin epineprine INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20170926 NDA NDA204200 General Injectables and Vaccines, Inc. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 52584-160_84a31872-0b7a-4976-bdc2-4533c31255df 52584-160 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100701 ANDA ANDA070590 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 52584-163_2f4baeab-6528-4a22-a5d1-5943be2c3a2d 52584-163 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION PERINEURAL 20100701 ANDA ANDA070597 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 52584-177_2e9cae59-505d-4e58-a1c8-ca68081af341 52584-177 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine INJECTION INFILTRATION 20100801 ANDA ANDA089635 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE 5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 52584-178_0d4dd2e0-634c-4749-a3f3-47650d4122b6 52584-178 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine INJECTION INFILTRATION 20100801 ANDA ANDA089644 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE 10; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 52584-182_7f849c6b-3320-4fa6-8a43-900f75adad44 52584-182 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine Lidocaine Hydrochloride and Epinephrine INJECTION, SOLUTION INFILTRATION 20100301 ANDA ANDA089646 General Injectables & Vaccines LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 20; 10 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 52584-196_dd48a5df-135e-4bba-b925-60bfd0ac968f 52584-196 HUMAN PRESCRIPTION DRUG THIAMINE HYDROCHLORIDE thiamine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130821 ANDA ANDA091623 General Injectables & Vaccines, Inc THIAMINE HYDROCHLORIDE 100 mg/mL N 20181231 52584-207_f46cd5f5-7fc9-4f04-955b-2608e63caa86 52584-207 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA062420 General Injectables & Vaccines, Inc GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 52584-213_8cd007ac-cb31-4e13-aa2a-7e1bd52b29da 52584-213 HUMAN PRESCRIPTION DRUG Diazepam Diazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100501 ANDA ANDA071583 General Injectables and Vaccines, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 52584-215_449ee750-6d89-4b31-b4aa-083b56f0dea5 52584-215 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100801 ANDA ANDA070256 General Injectables & Vaccines, Inc NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 52584-240_19c78682-1798-4ce4-a251-e5bdc57821df 52584-240 HUMAN PRESCRIPTION DRUG Phytonadione Phytonadione INJECTION, EMULSION PARENTERAL 20120914 ANDA ANDA083722 General Injectables & Vaccines, Inc PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 52584-241_99a07ad1-5808-4735-8cb8-fe142e0ddcfa 52584-241 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20100301 20180601 NDA NDA020800 General Injectables & Vaccines, Inc EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 52584-262_8e76e993-4dab-4f57-9c0b-6ce5c95f5d5c 52584-262 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100801 NDA NDA017029 General Injectables & Vaccines, Inc HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 52584-269_bc7ce430-9a37-4654-b256-3a7ef0643e9b 52584-269 HUMAN PRESCRIPTION DRUG Diprivan Diprivan INJECTION, EMULSION INTRAVENOUS 20100301 NDA NDA019627 General Injectables & Vaccines, Inc PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 52584-273_b48ad78a-590b-425a-93ef-118ebb5f6b29 52584-273 HUMAN PRESCRIPTION DRUG Diazepam Diazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100601 ANDA ANDA072079 General Injectables and Vaccines, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 52584-276_59aad029-a8e0-49f2-a9ae-77a87f39a322 52584-276 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride Anhydrous INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100901 ANDA ANDA088299 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 52584-277_2c1e9729-3e60-4ce8-819a-00762b1a05e7 52584-277 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride Anhydrous INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100901 ANDA ANDA088327 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52584-282_d7158328-4867-404b-a37b-37abbb83fd83 52584-282 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100401 ANDA ANDA088294 General Injectables & Vaccines LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 52584-285_5a947282-cbb1-467b-ad78-5aa0e92babc6 52584-285 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20100801 ANDA ANDA075160 General Injectables & Vaccines, Inc METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 52584-286_a3190270-a817-44a1-b428-03c57fbb3a13 52584-286 HUMAN PRESCRIPTION DRUG NAROPIN ropivacaine hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20140311 NDA NDA020533 General Injectables & Vaccines, Inc ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 52584-290_0597f240-eb96-468d-a021-6c659f387af7 52584-290 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100301 ANDA ANDA040140 General Injectables and Vaccines DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 52584-302_e5370ad8-d050-44ee-ba60-f2e33be638a6 52584-302 HUMAN PRESCRIPTION DRUG VASOPRESSIN vasopressin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20131217 UNAPPROVED DRUG OTHER Feneral Injectables & Vaccines, Inc VASOPRESSIN 20 [USP'U]/mL N 20181231 52584-308_4f402ddc-a349-4955-b8f4-220fda6e1853 52584-308 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA075857 General Injectables & Vaccines, Inc MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 52584-311_6fad028e-df63-47b6-a8e3-f2d92001cbf7 52584-311 HUMAN PRESCRIPTION DRUG Calcium Gluconate Calcium Gluconate INJECTION, SOLUTION INTRAVENOUS 20150611 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc. CALCIUM GLUCONATE 94 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 52584-323_9159e1f6-0222-46d4-b8ef-1373eb11e19e 52584-323 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100901 ANDA ANDA040302 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 52584-332_1c00367c-6239-4bd0-bfea-db8271bd38ca 52584-332 HUMAN PRESCRIPTION DRUG Sterile Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100901 ANDA ANDA062911 General Injectables & Vaccines, Inc VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 52584-369_7e57c030-51f0-429d-8f32-15cdf6e66a0f 52584-369 HUMAN PRESCRIPTION DRUG NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140507 ANDA ANDA072076 General Injectables & Vaccines, Inc. NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] E 20171231 52584-376_b73a80eb-4cc8-4802-b816-c33a0e17143e 52584-376 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100701 ANDA ANDA080817 General Injectables & Vaccines, Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 52584-400_bc353eb7-1e30-4e6c-bd33-0882ca090cca 52584-400 HUMAN PRESCRIPTION DRUG HEPARIN SODIUM heparin sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20110913 ANDA ANDA090808 General Injectables & Vaccines, Inc HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 52584-401_0720434a-6dba-451c-ad25-f6d6be3af49f 52584-401 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100401 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ATROPINE SULFATE .4 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 52584-402_b1ff75b8-6c92-424f-a253-e312a99b4069 52584-402 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20110913 ANDA ANDA090808 General Injectables & Vaccines, Inc HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 52584-410_be7d605c-1afa-4390-b0ea-330520e7b6ce 52584-410 HUMAN PRESCRIPTION DRUG Digoxin Digoxin INJECTION INTRAMUSCULAR; INTRAVENOUS 20100701 ANDA ANDA083391 General Injectables and Vaccines, Inc DIGOXIN .25 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 52584-411_ca95a1e5-fe0b-437f-b643-86e0bb6fe999 52584-411 HUMAN PRESCRIPTION DRUG ISOVUE-M 200 Iopamidol INJECTION, SOLUTION INTRATHECAL 20101105 NDA NDA018735 General Injectables & Vaccines, Inc. IOPAMIDOL 408 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 52584-414_e2d46ef2-f085-48c3-8025-208bfb04c1e3 52584-414 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100501 NDA NDA073118 General Injectables & Vaccines, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 52584-415_740b0130-1a54-4e0b-820e-f7da204d5eeb 52584-415 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate INJECTION, SOLUTION INTRAVENOUS 20160811 NDA NDA203629 General Injectables and Vaccines, Inc NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 52584-418_992a19d5-9417-44cc-9eaf-223024947414 52584-418 HUMAN PRESCRIPTION DRUG NITROSTAT nitroglycerin TABLET ORAL 20100301 NDA NDA021134 General Injectables & Vaccines, Inc NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 52584-420_d50b42e6-6308-41bf-a92e-06faae0f614a 52584-420 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140526 ANDA ANDA040802 General Injectables and Vaccines, Inc. DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52584-421_22bc1cad-e307-4369-a461-e5370df5b102 52584-421 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20150821 ANDA ANDA040803 General Injectables and Vaccines, Inc DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52584-422_4a9a8f85-883a-4365-979e-eb6a9ca807fd 52584-422 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20160218 ANDA ANDA040803 General Injectables and Vaccines, Inc DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52584-426_6563155a-ba5d-4ff7-9972-74318436a4f7 52584-426 HUMAN PRESCRIPTION DRUG Haloperidol Lactate Haloperidol INJECTION, SOLUTION INTRAMUSCULAR 20151013 ANDA ANDA078347 General Injectables and Vaccines, Inc. HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20181231 52584-443_8eea3193-dcd6-42d7-8dec-f56e2167ac0b 52584-443 HUMAN PRESCRIPTION DRUG Levophed Norepinephrine Bitartrate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100301 NDA NDA007513 General Injectables & Vaccines, Inc NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 52584-460_1cf116d3-baec-4e38-acae-6699ca835364 52584-460 HUMAN PRESCRIPTION DRUG Clindamycin Clindamycin INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 20160302 ANDA ANDA062800 General Injectables and Vaccines, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 52584-463_e9bbac64-37b4-4009-aa36-f2c1e36a53c1 52584-463 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride Nalbuphine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100301 ANDA ANDA070914 General Injectables & Vaccines, Inc NALBUPHINE HYDROCHLORIDE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] N 20181231 52584-465_b0615739-95d7-44dd-a0c0-11732c655160 52584-465 HUMAN PRESCRIPTION DRUG Sensorcaine Bupivacaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20111017 ANDA ANDA018304 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 52584-466_f3e3d417-6c31-4d59-8da9-3646702874a9 52584-466 HUMAN PRESCRIPTION DRUG Sensorcaine MPF bupivacaine hydrochloride INJECTION, SOLUTION EPIDURAL; INTRACAUDAL; PERINEURAL 20111026 ANDA ANDA070553 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 52584-467_7db41f3f-8e12-48cd-8c82-d2bd11593dda 52584-467 HUMAN PRESCRIPTION DRUG Sensorcaine Bupivacaine Hydrochloride INJECTION, SOLUTION PERINEURAL 20111018 ANDA ANDA018304 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 52584-469_b0cd3762-ad86-42ce-8995-4ec68f3a09a6 52584-469 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 20101227 ANDA ANDA072076 General Injectables & Vaccines, Inc. NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] E 20171231 52584-474_568759fb-c1ca-413e-8e71-ccf8992d2e86 52584-474 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol Lactate INJECTION INTRAMUSCULAR 20140929 ANDA ANDA075689 General Injectables and Vaccines, Inc HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] E 20171231 52584-475_96ceeb73-f2ab-401f-8e4a-fbb4ba1b2b71 52584-475 HUMAN PRESCRIPTION DRUG Nesacaine Chloroprocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20111003 NDA NDA009435 General Injectables & Vaccines, Inc CHLOROPROCAINE HYDROCHLORIDE 10 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 52584-476_9b252093-0494-4a65-a704-62a8593b8475 52584-476 HUMAN PRESCRIPTION DRUG NESACAINE chloroprocaine hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20130130 NDA NDA009435 General Injectables & Vaccines, Inc CHLOROPROCAINE HYDROCHLORIDE 20 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 52584-481_1b92c42b-d303-48c7-86a2-5f3fbc4697f1 52584-481 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine hydrochloride, epinephrine bitartrate injection, solution INJECTION, SOLUTION INFILTRATION; PERINEURAL 20110928 NDA NDA006488 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 5; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 52584-482_49818470-7b3c-4898-b184-a439e4fc2a6c 52584-482 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride and Epinephrine INJECTION, SOLUTION INFILTRATION; PERINEURAL 20110912 NDA NDA006488 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 10; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 52584-483_36b94618-2409-4e61-a609-d176eb8b74f6 52584-483 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride and epinephrine INJECTION, SOLUTION INFILTRATION; PERINEURAL 20111103 NDA NDA006488 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 52584-484_8ed37464-ef48-4900-b233-092cf9e6a810 52584-484 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20110921 NDA NDA006488 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 52584-485_e15c4e91-ad5c-401c-bb13-7967b507ffea 52584-485 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20110926 NDA NDA006488 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52584-485_e6b194fb-93a1-402a-a60a-2bcd15201de5 52584-485 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20111025 NDA NDA006488 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52584-486_4e60e990-266e-43f2-b5a5-35ffec0d0f9f 52584-486 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine HCl INJECTION, SOLUTION INFILTRATION; PERINEURAL 20111109 NDA NDA006488 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52584-489_e278b345-b90e-4fc4-9362-64f9787edc71 52584-489 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride and epinephrine INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20110927 NDA NDA006488 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 20; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 52584-493_ed45d120-11a3-45b0-80d6-7dc0e7d4b65b 52584-493 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100301 ANDA ANDA084307 General Injectables & Vaccines, Inc PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 52584-495_636cdddd-c300-4744-ab74-d79bd81a6f25 52584-495 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA083312 General Injectables & Vaccines, Inc PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 52584-496_80f384e6-0ba9-44a5-ad0d-472c4ea4078f 52584-496 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 20100801 ANDA ANDA083312 General Injectables & Vaccines, Inc PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 52584-503_8d74e26a-db7a-4e9c-86ad-9c6d12f5afe8 52584-503 HUMAN PRESCRIPTION DRUG DEHYDRATED ALCOHOL alcohol INJECTION INTRASPINAL 20140115 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc ALCOHOL .98 mL/mL N 20181231 52584-504_5d5c3c13-aeda-4706-ae94-3dba0faccbd1 52584-504 HUMAN PRESCRIPTION DRUG Methylene Blue Methylene Blue INJECTION, SOLUTION INTRAVENOUS 20100401 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc METHYLENE BLUE 10 mg/mL Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 52584-517_e9ce8141-eca7-4c42-98f7-3dda3824e955 52584-517 HUMAN PRESCRIPTION DRUG Dextrose Dextrose Monohydrate INJECTION, SOLUTION INTRAVENOUS 20100701 NDA NDA019445 General Injectables & Vaccines, Inc DEXTROSE MONOHYDRATE 25 g/50mL N 20181231 52584-534_17ed102d-23ae-4383-9ac8-6ddb88bcdb01 52584-534 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20100301 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc SODIUM BICARBONATE 42 mg/mL N 20191231 52584-540_a8cbb694-3e7e-49b5-aaac-be76b71af228 52584-540 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100801 NDA NDA017029 General Injectables & Vaccines, Inc HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 52584-542_b410928c-892c-44ad-ba2d-ed8eb4fb88a3 52584-542 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100301 NDA NDA017029 General Injectables & Vaccines, Inc HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 52584-555_91e4f488-b535-4e04-a609-79387a61c387 52584-555 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20110830 ANDA ANDA084307 General Injectables & Vaccines, Inc. PHENYTOIN SODIUM 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 52584-559_c1929c7e-54f9-4493-9384-3ec8daec9a86 52584-559 HUMAN PRESCRIPTION DRUG Marcaine Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100801 NDA NDA016964 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 52584-560_04862f0d-7ade-4f8c-b7d3-b66c42520e9e 52584-560 HUMAN PRESCRIPTION DRUG Marcaine Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL 20100801 NDA NDA016964 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 52584-560_4f3467d2-590a-4700-ac88-c8ffc4329ae3 52584-560 HUMAN PRESCRIPTION DRUG Marcaine Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100301 NDA NDA016964 General Injectables & Vaccines, Inc BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 52584-569_e112af78-0430-49cf-b564-ff84cfcca359 52584-569 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole INJECTION INTRAVENOUS 20100901 ANDA ANDA074521 General Injectables & Vaccines, Inc DIPYRIDAMOLE 5 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 52584-575_5b5904cf-c42b-4384-bd18-8f0620893ec2 52584-575 HUMAN PRESCRIPTION DRUG Dehydrated Alcohol Dehydrated Alcohol INJECTION, SOLUTION INTRASPINAL 20170327 UNAPPROVED DRUG OTHER General Injectables and Vaccines, Inc. ALCOHOL .98 mL/mL N 20181231 52584-596_191ab2cc-06a6-4071-9129-19c6c8c5774a 52584-596 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171130 ANDA ANDA075293 General Injectables and Vaccines, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 52584-601_9b53c8d6-43e2-422b-83d8-040a2d006798 52584-601 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine INJECTION, SOLUTION INTRAMUSCULAR 20100301 ANDA ANDA087408 General Injectables & Vaccines, Inc HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 52584-605_33d6ce53-b1b5-428d-9ddc-a70fcb00aa8f 52584-605 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120220 ANDA ANDA089335 General Injectables & Vaccines, Inc GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 52584-609_4958bcfb-0137-45fb-92cb-f07c05e5ab14 52584-609 HUMAN PRESCRIPTION DRUG Neut 4% Sodium Bicarbonate Additive Solution INJECTION, SOLUTION INTRAVENOUS 20140731 UNAPPROVED DRUG OTHER General Injectables and Vaccines, Inc SODIUM BICARBONATE .2 g/5mL N 20181231 52584-610_9882f849-7b98-4307-9821-bef033ab85bc 52584-610 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine INJECTION, SOLUTION INTRAMUSCULAR 20100301 ANDA ANDA087408 General Injectables & Vaccines, Inc HYDROXYZINE HYDROCHLORIDE 50 mg/mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 52584-614_4c31222b-b500-42ce-9e4f-d4fffefdd852 52584-614 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVASCULAR 20111019 ANDA ANDA040388 General Injectables & Vaccines, Inc HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 52584-616_ed10efa1-7b31-4146-9665-8dc480da1323 52584-616 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20170607 ANDA ANDA075761 General Injectables and Vaccines, Inc. AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 52584-625_70ed85ac-5759-48d1-a4ee-ff37ef2290b9 52584-625 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc SODIUM BICARBONATE 84 mg/mL N 20181231 52584-626_7911725d-b7b1-4269-85de-b000bb3229f6 52584-626 HUMAN PRESCRIPTION DRUG BUTORPHANOL TARTRATE butorphanol tartrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130814 ANDA ANDA074626 General Injectables & Vaccines, Inc BUTORPHANOL TARTRATE 2 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV N 20181231 52584-630_faa462a1-176c-499c-b279-d092d07c0db4 52584-630 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100301 NDA NDA021146 General Injectables & Vaccines, Inc. ATROPINE SULFATE .05 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 52584-631_2bc34c7f-6e67-443e-a4ef-a00d559f7c36 52584-631 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION, SOLUTION INTRAVENOUS 20100701 NDA NDA021117 General Injectables & Vaccines, Inc CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 52584-633_3ee02915-b121-4e1a-8022-e4dca2e0eb35 52584-633 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100301 ANDA ANDA075136 General Injectables & Vaccines, Inc VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 52584-637_979427d7-0a29-4053-bb73-0c38db2c5a03 52584-637 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20100801 ANDA ANDA077394 General Injectables & Vaccines, Inc SODIUM BICARBONATE 84 mg/mL N 20181231 52584-641_d180e389-725f-4462-9392-c0b2252265e7 52584-641 HUMAN PRESCRIPTION DRUG Suprane Desflurane LIQUID RESPIRATORY (INHALATION) 20120425 NDA NDA020118 General Injectables & Vaccines, Inc DESFLURANE 240 mL/240mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 52584-642_f30dba86-a0f1-46de-8bd4-fb693e186763 52584-642 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170113 NDA NDA019316 General Injectables and Vaccines, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 52584-648_29b3b17b-b28a-4e43-a227-d7ffa4c4f4c0 52584-648 HUMAN PRESCRIPTION DRUG Dextrose Dextrose Monohydrate INJECTION, SOLUTION INTRAVENOUS 20100701 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc DEXTROSE MONOHYDRATE 25 g/50mL N 20181231 52584-651_95205d76-9f33-4549-9d75-fbfe73054b1e 52584-651 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20151116 ANDA ANDA080205 General Injectables and Vaccines, Inc. POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 52584-653_0aaab2d5-7581-4dd0-ab26-5e4f01cea67f 52584-653 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100801 ANDA ANDA080205 General Injectables & Vaccines, Inc POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 52584-656_37d820f4-6771-4d57-86a0-6fb656ffab30 52584-656 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20100301 ANDA ANDA070974 General Injectables & Vaccines, Inc CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 52584-664_06d05610-6ea8-4887-8433-b617b2ee1a85 52584-664 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170613 ANDA ANDA040466 General Injectables and Vaccines, Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 52584-665_078cf500-3002-41a3-bb0d-ef5d2cc5d1fd 52584-665 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate INJECTION, SOLUTION SUBCUTANEOUS 20111116 ANDA ANDA076887 General Injectables & Vaccines, Inc TERBUTALINE SULFATE 1 mg/mL N 20181231 52584-695_69d86d79-d84d-45f7-ab1f-ff4aae6c48c3 52584-695 HUMAN PRESCRIPTION DRUG Amidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20100801 NDA NDA018227 General Injectables & Vaccines, Inc ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 52584-699_5db877a1-3e20-49d2-8ba4-29435ab1a080 52584-699 HUMAN PRESCRIPTION DRUG Propofol Propofol INJECTION, EMULSION INTRAVENOUS 20140821 ANDA ANDA077908 General Injectables and Vaccines, Inc PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 52584-713_3fd9c5f6-15c9-40f9-83b2-bbf3099d8591 52584-713 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride Anhydrous INJECTION, SOLUTION INFILTRATION 20100901 ANDA ANDA080408 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 52584-754_d2d10ef8-4bd1-4119-982a-ff5d35ed2f08 52584-754 HUMAN PRESCRIPTION DRUG Magnesium Sulfate Magnesium Sulfate Heptahydrate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 ANDA ANDA075151 General Injectables & Vaccines, Inc MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 52584-775_2f1140b5-1a09-41cb-980e-5e5983086255 52584-775 HUMAN PRESCRIPTION DRUG Infant Dextrose Dextrose INJECTION, SOLUTION INTRAVENOUS 20100701 NDA NDA019445 General Injectables & Vaccines, Inc DEXTROSE MONOHYDRATE 250 mg/mL N 20181231 52584-782_2497274d-a127-4b36-b839-181232fb7ce7 52584-782 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100301 ANDA ANDA070172 General Injectables & Vaccines, Inc NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 52584-783_6b3fd99d-d25f-488a-8b3c-bb8b95669ccf 52584-783 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION, SOLUTION INTRAVENOUS 20140916 ANDA ANDA078527 General Injectables and Vaccines, Inc. FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 52584-784_4225ebda-1eba-4ab8-a888-a14570e1acbd 52584-784 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20140710 ANDA ANDA078527 General Injectables and Vaccines, Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] E 20171231 52584-795_302a1d6b-0e22-43a3-89f7-324a2847781e 52584-795 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120410 ANDA ANDA074802 General Injectables & Vaccines, Inc KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 52584-796_1658c307-c6c9-4deb-ab13-4d773028b05a 52584-796 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR 20120410 ANDA ANDA074802 General Injectables & Vaccines, Inc KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 52584-810_1121791a-27d5-4f6d-8223-7424846a9909 52584-810 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin INJECTION, SOLUTION INTRAVENOUS 20100601 ANDA ANDA072034 General Injectables and Vaccines, Inc. NITROGLYCERIN 5 mg/mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 52584-820_cdf014e2-3493-40b0-a5c9-19d07ae90e1f 52584-820 HUMAN PRESCRIPTION DRUG Dopamine Hydrochloride Dopamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20150918 NDA NDA018132 General Injectables and Vaccines, Inc. DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 52584-870_865e8334-e293-4ec6-8543-add146dfa883 52584-870 HUMAN PRESCRIPTION DRUG CLEOCIN PHOSPHATE clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121019 NDA NDA050441 General Injectables & Vaccines, Inc CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 52584-872_4d07d7ce-c68d-480d-b0ea-8cdb5f84fe65 52584-872 HUMAN PRESCRIPTION DRUG Propranolol Propranolol INJECTION INTRAVENOUS 20110222 ANDA ANDA077760 General Injectables & Vaccines, Inc PROPRANOLOL HYDROCHLORIDE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 52584-875_ea4b3c89-71a6-497e-a34a-fac5e5f0dddb 52584-875 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20140902 20181231 ANDA ANDA077234 General Injectables and Vaccines, Inc. AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 52584-887_9459cd3e-dafe-4958-84f0-3d8ce5b7fa80 52584-887 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100301 NDA NDA018801 General Injectables & Vaccines, Inc WATER 1 mL/mL N 20181231 52584-888_2849f238-5448-483b-ae0a-e27dbe3b4473 52584-888 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100801 NDA NDA018803 General Injectables & Vaccines, Inc SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 52584-900_373bcb85-1387-4d38-be82-57b9457e7863 52584-900 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20100801 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc SODIUM BICARBONATE 84 mg/mL N 20181231 52584-902_a71b6c57-2281-4b52-92e8-c4de6cd10549 52584-902 HUMAN PRESCRIPTION DRUG Dextrose Dextrose INJECTION, SOLUTION INTRAVENOUS 20100929 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc. DEXTROSE MONOHYDRATE 25 g/50mL N 20181231 52584-903_d88397c0-e1c7-486b-b648-cd47ea876654 52584-903 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100901 ANDA ANDA083158 General Injectables & Vaccines, Inc LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52584-904_573d42b7-0520-467e-bbef-34c7b9929de1 52584-904 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine INJECTION, SOLUTION INTRAVENOUS 20100301 ANDA ANDA083158 General Injectables & Vaccine, Inc LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 52584-910_9afefc1d-ec72-471a-88be-d7e2a0546b46 52584-910 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100301 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc. ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 52584-916_0a89a5fb-02a2-4760-b7c1-837506c631c0 52584-916 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20110310 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc. SODIUM BICARBONATE 75 mg/mL N 20181231 52584-921_ffb6f4a4-b785-4caf-83d8-4ec0cca67975 52584-921 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline INJECTION, SOLUTION INTRAVENOUS 20100701 ANDA ANDA087242 General Injectables & Vaccines, Inc AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 52584-922_a0884afb-0776-4927-9901-eedc95232d4c 52584-922 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline INJECTION, SOLUTION INTRAVENOUS 20090101 ANDA ANDA087242 General Injectables & Vaccines, Inc. AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 52584-928_eed2b785-5a5f-46cb-a2f5-f378bc456418 52584-928 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Choride INJECTION, SOLUTION INTRAVENOUS; INTRAVENTRICULAR 20100301 UNAPPROVED DRUG OTHER General Injectables & Vaccines, Inc. CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 52584-931_810e51fe-c57a-4356-a191-6df25d42b816 52584-931 HUMAN PRESCRIPTION DRUG Infed Iron Dextran INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100901 NDA NDA017441 General Injectables & Vaccines, Inc IRON DEXTRAN 50 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 52584-965_9fd8ee03-8aba-424c-81ef-0dcc1fa9f518 52584-965 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100801 ANDA ANDA088901 General Injectables & Vaccines, Inc POTASSIUM CHLORIDE 2 meq/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 52584-966_12a5ae66-6f3a-484a-80d8-cfcd2863633d 52584-966 HUMAN PRESCRIPTION DRUG Bacteriostatic Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100601 NDA NDA018800 General Injectables & Vaccines, Inc. SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 52584-977_25bf0c5b-5933-4407-91cb-87fef37b3e92 52584-977 HUMAN PRESCRIPTION DRUG Bacteriostatic Water Water INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100801 NDA NDA018802 General Injectables & Vaccine, Inc WATER 1 mL/mL N 20181231 52584-978_35629d7f-b611-47a6-b5b3-c0d7a73e815f 52584-978 HUMAN PRESCRIPTION DRUG NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTION PARENTERAL 20131206 ANDA ANDA072076 General Injectables & Vaccines, Inc NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 52599-282_5f3b6e5c-8332-2f0d-e053-2a91aa0a7d0f 52599-282 HUMAN OTC DRUG Baclezene Neomycin Sulfate CREAM TOPICAL 20140619 OTC MONOGRAPH FINAL part333B Curazene, LLC NEOMYCIN SULFATE 5 mg/.9g N 20181231 52605-014_381cb51a-04d7-4f8c-b572-613d9cae3425 52605-014 HUMAN OTC DRUG THRULIFE EXTRA STRENGTH HEADACHE RELIEF Acetaminophen, Aspirin, Caffeine TABLET ORAL 20130131 OTC MONOGRAPH FINAL part343 Polygen Pharmaceuticals LLC ACETAMINOPHEN; CAFFEINE; ASPIRIN 250; 65; 250 mg/1; mg/1; mg/1 E 20171231 52605-022_c9bb6b1d-2ad8-4852-8b45-b44ccc330172 52605-022 HUMAN PRESCRIPTION DRUG Phentermine hydrochloride Phentermine hydrochloride TABLET ORAL 20161118 ANDA ANDA206342 POLYGEN PHARMACEUTICALS INC. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 52605-041_0dd4836f-689d-4319-892a-b6e859a25e76 52605-041 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20160711 ANDA ANDA207821 POLYGEN PHARMACEUTICALS INC. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 52605-042_0dd4836f-689d-4319-892a-b6e859a25e76 52605-042 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20160711 ANDA ANDA207821 POLYGEN PHARMACEUTICALS INC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 52605-043_0dd4836f-689d-4319-892a-b6e859a25e76 52605-043 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20160711 ANDA ANDA207821 POLYGEN PHARMACEUTICALS INC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 52605-114_c265106e-3575-4073-8195-0aa0adb10f45 52605-114 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20120605 ANDA ANDA091239 Polygen Pharmaceuticals LLC IBUPROFEN 200 mg/1 E 20171231 52605-117_c265106e-3575-4073-8195-0aa0adb10f45 52605-117 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20120605 ANDA ANDA091239 Polygen Pharmaceuticals LLC IBUPROFEN 200 mg/1 N 20181231 52605-120_a5e2a7fd-dc7e-4f1b-9436-41b9834caaab 52605-120 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20130702 ANDA ANDA091237 Polygen Pharmaceuticals LLC IBUPROFEN 200 mg/1 N 20181231 52605-121_c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e 52605-121 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20111128 ANDA ANDA090796 Polygen Pharmaceuticals LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52605-122_c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e 52605-122 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20111128 ANDA ANDA090796 Polygen Pharmaceuticals LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52605-123_c63c2921-fc55-4ad8-a5e5-0d7258ab1f4e 52605-123 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20111128 ANDA ANDA090796 Polygen Pharmaceuticals LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52605-138_d349356e-61d3-4728-8425-1a4d513605d9 52605-138 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20120201 ANDA ANDA091416 Polygen Pharmaceuticals LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52605-139_d349356e-61d3-4728-8425-1a4d513605d9 52605-139 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20120201 ANDA ANDA091416 Polygen Pharmaceuticals LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52605-140_d349356e-61d3-4728-8425-1a4d513605d9 52605-140 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20120201 ANDA ANDA091416 Polygen Pharmaceuticals LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52605-141_b06d4755-1fbf-4fcf-9075-cb1691292aad 52605-141 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, COATED ORAL 20120611 ANDA ANDA090545 Polygen Pharmaceuticals LLC NAPROXEN SODIUM 220 mg/1 E 20171231 52605-144_b06d4755-1fbf-4fcf-9075-cb1691292aad 52605-144 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, COATED ORAL 20121113 ANDA ANDA090545 Polygen Pharmaceuticals LLC NAPROXEN SODIUM 220 mg/1 N 20181231 52609-0001_369db993-feaf-606d-0a3d-681b92d684db 52609-0001 HUMAN PRESCRIPTION DRUG ALKERAN melphalan TABLET, FILM COATED ORAL 20110101 NDA NDA014691 ApoPharma USA, Inc. MELPHALAN 2 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 52609-0006_2a17ed6d-d231-46ff-a0e5-25a302267f4b 52609-0006 HUMAN PRESCRIPTION DRUG FERRIPROX deferiprone TABLET, FILM COATED ORAL 20111125 NDA NDA021825 ApoPharma USA, Inc. DEFERIPRONE 500 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] N 20181231 52609-3001_12d1ebd7-807f-4cf4-95e2-cc6ebf52631a 52609-3001 HUMAN PRESCRIPTION DRUG ALKERAN melphalan hydrochloride KIT 20110101 NDA NDA020207 Apo-Pharma USA, Inc E 20171231 52609-4502_13547d90-1904-7bd3-8199-8e92b452c829 52609-4502 HUMAN PRESCRIPTION DRUG FERRIPROX deferiprone SOLUTION ORAL 20150909 NDA NDA208030 ApoPharma USA, Inc. DEFERIPRONE 100 mg/mL Iron Chelating Activity [MoA],Iron Chelator [EPC] N 20181231 52625-100_842f10be-4055-47b9-89f9-50e791f9f668 52625-100 HUMAN OTC DRUG Moisturizing Sunblock Titanium Dioxide LOTION TOPICAL 20100701 OTC MONOGRAPH FINAL part352 Vienna Health and Beauty Corporation TITANIUM DIOXIDE; OCTINOXATE; BENZOPHENONE 8; 6; 3 g/100g; g/100g; g/100g E 20171231 52625-101_30b7ef3a-0034-45f8-978b-fb32462f3080 52625-101 HUMAN OTC DRUG Sunblock Titanium Dioxide LOTION TOPICAL 20100701 OTC MONOGRAPH FINAL part352 Vienna Health and Beauty Corporation TITANIUM DIOXIDE; OCTINOXATE 6; 5 g/80g; g/80g E 20171231 52641-300_e1b7994f-93dc-4003-b71c-e60e4c54e070 52641-300 HUMAN OTC DRUG ReliaMed Zinc Oxide, Calamine DRESSING TOPICAL 20100813 OTC MONOGRAPH FINAL part347 Reliamed ZINC OXIDE; FERRIC OXIDE RED; ZINC OXIDE 25; .015; .985 g/1; g/1; g/1 E 20171231 52641-302_17da0d39-89b7-499f-8934-12f6464957e3 52641-302 HUMAN OTC DRUG Reliamed Zinc Oxide DRESSING TOPICAL 20100813 OTC MONOGRAPH FINAL part347 Reliamed ZINC OXIDE 25 g/1 E 20171231 52641-700_1d92f29c-b098-4399-8340-673f8033c3da 52641-700 HUMAN OTC DRUG Antiseptic isopropyl alcohol LIQUID TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part333A ReliaMed ISOPROPYL ALCOHOL .56118 g/mL N 20181231 52642-001_7a0a45ca-71f5-4fb5-9ba3-a065d4cf9ceb 52642-001 HUMAN OTC DRUG BestHealth Menthol MENTHOL LOZENGE ORAL 20121220 OTC MONOGRAPH FINAL part341 Bestco Inc. MENTHOL 5.4 mg/1 N 20181231 52642-002_a646fa21-aef6-4e34-8bd7-a1f576894d42 52642-002 HUMAN OTC DRUG BestHealth Cherry MENTHOL LOZENGE ORAL 20130115 OTC MONOGRAPH FINAL part341 Bestco, Inc. MENTHOL 5.8 mg/1 N 20181231 52642-005_f0340516-800c-4dfa-b05e-dee77197dca4 52642-005 HUMAN OTC DRUG BestHealth Honey Lemon MENTHOL LOZENGE ORAL 20130115 OTC MONOGRAPH FINAL part341 Bestco, Inc. MENTHOL 7.5 mg/1 N 20181231 52642-008_703ceaa3-dabd-47ea-ad5a-d03d059ce330 52642-008 HUMAN OTC DRUG BestHealth Cough Suppressant SUGAR FREE HONEY LEMON FLAVOR MENTHOL LOZENGE ORAL 20140305 OTC MONOGRAPH FINAL part341 Bestco, Inc. MENTHOL 7.6 mg/1 N 20181231 52642-009_62842bc9-254e-4750-b672-bd23cc147d97 52642-009 HUMAN OTC DRUG BestHealth Cough Suppressant SUGAR FREE BLACK CHERRY FLAVOR MENTHOL LOZENGE ORAL 20140305 OTC MONOGRAPH FINAL part341 Bestco, Inc. MENTHOL 5.8 mg/1 N 20181231 52642-010_66f8627c-44ca-4909-8493-36f00454b915 52642-010 HUMAN OTC DRUG Best Health Sore Throat Relief Cherry Flavor BENZOCAINE, MENTHOL LOZENGE ORAL 20140604 OTC MONOGRAPH NOT FINAL part356 Bestco, Inc. BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 52642-011_4bce3e4d-c053-613e-e054-00144ff8d46c 52642-011 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20140529 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 7.5 mg/1 N 20181231 52642-012_4bceb540-5a0e-0167-e054-00144ff8d46c 52642-012 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20150427 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 5.8 mg/1 N 20181231 52642-013_4bcf46aa-fa4d-51bf-e054-00144ff88e88 52642-013 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20150427 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 7.5 mg/1 N 20181231 52642-014_4bcfe1ad-3c06-347e-e054-00144ff8d46c 52642-014 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20150616 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 5.8 mg/1 N 20181231 52642-015_4bded4c7-e835-38aa-e054-00144ff8d46c 52642-015 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20150616 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 7.5 mg/1 N 20181231 52642-016_4bdfa255-4db0-031f-e054-00144ff88e88 52642-016 HUMAN OTC DRUG SF Menthol Cough Drop Menthol LOZENGE ORAL 20150630 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 5.8 mg/1 N 20181231 52642-017_4bf3a064-699a-3d59-e054-00144ff8d46c 52642-017 HUMAN OTC DRUG Throat Relief Lozenges Benzocaine LOZENGE ORAL 20120730 OTC MONOGRAPH NOT FINAL part356 BestCo Inc. MENTHOL; BENZOCAINE 3.6; 15 mg/1; mg/1 N 20181231 52642-018_4be0bf1f-5ff3-1ecf-e054-00144ff88e88 52642-018 HUMAN OTC DRUG Throat Relief Pops Pectin LOZENGE ORAL 20160505 OTC MONOGRAPH NOT FINAL part356 BestCo Inc. PECTIN 10 mg/1 N 20181231 52642-019_4be19c3e-405f-3ff4-e054-00144ff88e88 52642-019 HUMAN OTC DRUG Cherry Antacid Softchew Calcium Carbonate TABLET, CHEWABLE ORAL 20140314 OTC MONOGRAPH FINAL part331 BestCo Inc. CALCIUM CARBONATE 1177 mg/1 N 20181231 52642-020_26a22cfd-395c-4ffb-e054-00144ff88e88 52642-020 HUMAN OTC DRUG Strawberry Cough Drops Menthol LOZENGE ORAL 20110701 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 2.7 mg/1 N 20181231 52642-021_4be28e4b-6cd0-6b26-e054-00144ff8d46c 52642-021 HUMAN OTC DRUG Orange Antacid Softchew Calcium Carbonate TABLET, CHEWABLE ORAL 20140314 OTC MONOGRAPH FINAL part331 BestCo Inc. CALCIUM CARBONATE 1177 mg/1 N 20181231 52642-022_4c6c7b25-b8b6-483a-e054-00144ff8d46c 52642-022 HUMAN OTC DRUG Cherry Antacid Soft Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20150609 OTC MONOGRAPH FINAL part331 BestCo Inc. CALCIUM CARBONATE 1177 mg/1 N 20181231 52642-023_4b6b6d27-03fa-16a4-e054-00144ff88e88 52642-023 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20141007 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 5.4 1/1 N 20181231 52642-024_4b6c2a8c-b399-58c3-e054-00144ff8d46c 52642-024 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20121231 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 5.8 mg/1 N 20181231 52642-025_4bb6eca6-caf0-2065-e054-00144ff8d46c 52642-025 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20121231 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 7.5 mg/1 N 20181231 52642-026_4bb82570-ae1e-5c24-e054-00144ff8d46c 52642-026 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20140529 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 5.8 mg/1 N 20181231 52642-027_55520396-b968-0eaf-e054-00144ff88e88 52642-027 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20170726 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 5.8 mg/1 N 20181231 52642-028_5560ab5b-fdc9-48c9-e054-00144ff88e88 52642-028 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20170726 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 5.8 mg/1 N 20181231 52642-029_5561ba68-67df-6d30-e054-00144ff88e88 52642-029 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20170726 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 7.5 mg/1 N 20181231 52642-030_55629855-d1ae-0d66-e054-00144ff8d46c 52642-030 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20170726 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 7.5 mg/1 N 20181231 52642-031_55651d44-8c2a-0162-e054-00144ff8d46c 52642-031 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20170726 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 7.5 mg/1 N 20181231 52642-032_5565f0af-aaea-222c-e054-00144ff8d46c 52642-032 HUMAN OTC DRUG Herbal Menthol Cough Drop Menthol LOZENGE ORAL 20170726 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 4.8 mg/1 N 20181231 52642-033_55b1f6b6-bf1a-3d7b-e054-00144ff88e88 52642-033 HUMAN OTC DRUG Sugar Free Menthol Cough Drop Menthol LOZENGE ORAL 20170726 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 5.8 mg/1 N 20181231 52642-034_55b2b35f-4770-1cc2-e054-00144ff8d46c 52642-034 HUMAN OTC DRUG Antacid Flavor Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20170726 OTC MONOGRAPH FINAL part331 BestCo Inc. CALCIUM CARBONATE 750 mg/1 N 20181231 52642-100_2fd59176-e98e-1a93-e054-00144ff88e88 52642-100 HUMAN OTC DRUG Menthol cough drops menthol LOZENGE ORAL 20140718 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 5.8 mg/1 N 20181231 52642-101_2fe50679-ea1f-36b1-e054-00144ff88e88 52642-101 HUMAN OTC DRUG BestCo Inc. Menthol LOZENGE ORAL 20140721 OTC MONOGRAPH FINAL part341 BestCo Inc. MENTHOL 5.4 mg/1 N 20181231 52642-225_2b82a096-4376-1e5a-e054-00144ff8d46c 52642-225 HUMAN OTC DRUG Tropical Panned calcium carbonate, simethicone TABLET, CHEWABLE ORAL 20140319 OTC MONOGRAPH FINAL part331 BestCo Inc. CALCIUM CARBONATE; DIMETHICONE 750; 80 mg/1; mg/1 N 20181231 52642-226_2b95d0b8-a30b-667d-e054-00144ff8d46c 52642-226 HUMAN OTC DRUG Alka Seltzer Calcium carbonate TABLET, CHEWABLE ORAL 20130208 OTC MONOGRAPH FINAL part331 BestCo Inc. CALCIUM CARBONATE 750 mg/1 N 20181231 52642-227_2bd093ea-ad8c-5b27-e054-00144ff8d46c 52642-227 HUMAN OTC DRUG Assorted Fruit calcium carbonate TABLET, CHEWABLE ORAL 20150831 OTC MONOGRAPH FINAL part331 BestCo Inc CALCIUM CARBONATE 750 mg/1 N 20181231 52642-228_2bd244bb-bf90-2c71-e054-00144ff8d46c 52642-228 HUMAN OTC DRUG Assorted Fruit Panned calcium carbonate TABLET, CHEWABLE ORAL 20150831 OTC MONOGRAPH FINAL part331 BestCo CALCIUM CARBONATE 750 mg/1 N 20181231 52642-229_2be40c27-c2f3-090e-e054-00144ff88e88 52642-229 HUMAN OTC DRUG Assorted Fruit Panned calcium carbonate TABLET, CHEWABLE ORAL 20141001 OTC MONOGRAPH FINAL part331 BestCo Inc CALCIUM CARBONATE 750 mg/1 N 20181231 52642-230_2bd3f180-802c-169e-e054-00144ff88e88 52642-230 HUMAN OTC DRUG Tropical Panned calcium carbonate, simethicone TABLET, CHEWABLE ORAL 20151002 OTC MONOGRAPH FINAL part331 BestCo Inc. CALCIUM CARBONATE; DIMETHICONE 750; 80 mg/1; mg/1 N 20181231 52642-231_2c8815e6-5ac5-21c5-e054-00144ff8d46c 52642-231 HUMAN OTC DRUG Zicam Kids Cold Relief Remedy soft chews TABLET, CHEWABLE ORAL 20140506 UNAPPROVED HOMEOPATHIC BestCo Inc. ZINC ACETATE; ZINC GLUCONATE 3.54; 4.5 mg/1; mg/1 N 20181231 52642-232_2c85aa8b-eb86-0134-e054-00144ff8d46c 52642-232 HUMAN OTC DRUG Zicam Cold Remedy Soft Chews Zincum aceticum, Zincum gluconicum, Caffeinum TABLET, CHEWABLE ORAL 20150420 UNAPPROVED HOMEOPATHIC BestCo Inc. ZINC ACETATE; CAFFEINE; ZINC GLUCONATE 3.53; .03; 4.47 mg/1; mg/1; mg/1 N 20181231 52644-001_5acd8ebf-2b8e-40d6-a76d-7bad43ff0658 52644-001 HUMAN OTC DRUG Oral Defense Cetylpyridinium Chloride MOUTHWASH ORAL 20100726 OTC MONOGRAPH NOT FINAL part356 Oral Defense, LLC CETYLPYRIDINIUM CHLORIDE .47 mL/474mL E 20171231 52644-002_bc01abf8-ac41-40c1-a4ab-1d4ba7c64a42 52644-002 HUMAN OTC DRUG Oral Defense Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20100831 OTC MONOGRAPH FINAL part355 Oral Defense, LLC SODIUM FLUORIDE .2418 g/474mL E 20171231 52644-003_d9a9c8ea-b2da-4f23-ad65-23b174df6f9d 52644-003 HUMAN OTC DRUG Oral Defense Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110712 OTC MONOGRAPH FINAL part355 Oral Defense SODIUM FLUORIDE .14 g/118g E 20171231 52648-6175_556865f0-7dda-46b4-9948-d987b95f740f 52648-6175 HUMAN OTC DRUG Sunscreen Wipe KGP HOMOSALATE OCTINOXATE OCTISALATE OXYBENZONE CLOTH TOPICAL 20100928 OTC MONOGRAPH FINAL part352 KGP Products, Inc. (dba PREMIER) HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 40; 50 g/856mL; g/856mL; g/856mL; g/856mL E 20171231 52651-001_28a59a0a-df17-41c1-a5b7-286ff7ae489e 52651-001 HUMAN OTC DRUG TN Dickinsons Witch Hazel Astringent Witch Hazel LIQUID TOPICAL 19891202 OTC MONOGRAPH FINAL part347 Dickinson Brands Inc. WITCH HAZEL 86 g/100mL N 20181231 52651-003_47917e5a-92d3-433b-a7ca-013881dc55f5 52651-003 HUMAN OTC DRUG TN Dickinsons Witch Hazel Hemorrhoidal Pads witch hazel CLOTH TOPICAL 19941201 OTC MONOGRAPH FINAL part346 Dickinson Brands Inc. WITCH HAZEL 1.2 g/1 E 20171231 52651-006_4af7eadc-0118-4078-bb24-7b58582432c7 52651-006 HUMAN OTC DRUG TN Dickinsons Witch Hazel Antibacterial benzethonium chloride SPRAY TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333A Dickinson Brands Inc. BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 52652-1001_8d10df83-cba9-4a02-a127-f7eb75418c89 52652-1001 HUMAN PRESCRIPTION DRUG EPANED enalapril maleate KIT 20130822 NDA NDA204308 Silvergate Pharmaceuticals, Inc. N 20191231 52652-2001_0720aa9a-4a0d-49e0-90f6-a35e92ec8128 52652-2001 HUMAN PRESCRIPTION DRUG Xatmep Methotrexate SOLUTION ORAL 20170501 NDA NDA208400 Silvergate Pharmaceuticals, Inc. METHOTREXATE 2.5 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 52652-3001_30eea2bf-13ff-4a30-b8bf-89a14cc0dd9c 52652-3001 HUMAN PRESCRIPTION DRUG Qbrelis lisinopril SOLUTION ORAL 20160829 NDA NDA208401 Silvergate Pharmaceuticals, Inc. LISINOPRIL 1 mg/mL Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 52652-4001_637c9427-ff17-4c59-9c8b-06ff4b479682 52652-4001 HUMAN PRESCRIPTION DRUG Epaned enalapril maleate SOLUTION ORAL 20161003 NDA NDA208686 Silvergate Pharmaceuticals, Inc. ENALAPRIL MALEATE 1 mg/mL Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 52654-0001_8ee70936-6e3a-44a3-a70d-032340d31213 52654-0001 HUMAN OTC DRUG MP Achyrocline Satureioides, Arctostaphylos Uva Ursi Leaf, Cassia Occidentalis, Mirabilis Jalapa, Petiveria Alliacea, Physalis Angulata, Schinus Molle LIQUID ORAL 20160518 UNAPPROVED HOMEOPATHIC Chi Research, Inc. ACHYROCLINE SATUREIOIDES; ARCTOSTAPHYLOS UVA-URSI LEAF; SENNA OCCIDENTALIS; MIRABILIS JALAPA FLOWERING TOP; PETIVERIA ALLIACEA WHOLE; PHYSALIS ANGULATA; SCHINUS MOLLE BARK 32; 32; 32; 32; 32; 32; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 52654-0002_cdb3aae1-2130-49ae-98ae-bbb80e12568a 52654-0002 HUMAN OTC DRUG DNA DNA LIQUID ORAL 20121009 UNAPPROVED HOMEOPATHIC Chi Research Inc HERRING SPERM DNA 12 [hp_X]/mL N 20181231 52654-0003_131334d6-9ef4-4e2c-800d-fb16b7d3f6b5 52654-0003 HUMAN OTC DRUG SP Brosimum Acutifolium, Himatanthus Sucuuba, Mansoa Alliacea, Minquartia Guianensis, Phyllanthus Niruri, Piper Aduncum LIQUID ORAL 20160518 UNAPPROVED HOMEOPATHIC Chi Research, Inc. BROSIMUM ACUTIFOLIUM BARK; HIMATANTHUS LANCIFOLIUS BARK; MANSOA ALLIACEA BARK; MANSOA ALLIACEA LEAF; MINQUARTIA GUIANENSIS BARK; PHYLLANTHUS NIRURI WHOLE; PIPER ADUNCUM LEAF 32; 32; 32; 32; 32; 32; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 52654-0004_b493a652-b903-4225-b566-b8941a0fcba4 52654-0004 HUMAN OTC DRUG MRCL Cinnamon Bark Essential Oil, Clove Bud Essential Oil, Eucalyptus Essential Oil, Lemon Essential Oil, Wild Rosemary Essential Oil LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC Chi Research, Inc. CINNAMON BARK OIL; CLOVE OIL; EUCALYPTUS OIL; LEMON OIL; ROSEMARY OIL 12; 12; 12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 52664-001_ec9df69b-cfb9-42b7-a934-d5823755720b 52664-001 HUMAN OTC DRUG ELF Super Glossy Lip Shine SPF 15 OXYBENZONE CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Hangzhou Facecare Cosmetics Co., Ltd. OXYBENZONE; OCTINOXATE 5; 7 g/100g; g/100g N 20181231 52664-002_546c9d9a-c668-45c8-8d63-e0c069fda4c0 52664-002 HUMAN OTC DRUG ELF Milk and Honey Cleansing Anti-bacterial Hand TRICLOSAN LIQUID TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333A Hangzhou Facecare Cosmetics Co., Ltd. TRICLOSAN .2 g/100g N 20181231 52664-003_d186b07b-df73-47af-bc67-767079051d5e 52664-003 HUMAN OTC DRUG ELF Tinted Moisturizer SPF 15 OXYBENZONE CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Hangzhou Facecare Cosmetics Co., Ltd. OXYBENZONE; OCTINOXATE 5; 7 g/100g; g/100g N 20181231 52664-004_071e0740-ae99-49a4-9089-e5ed67f87c5b 52664-004 HUMAN OTC DRUG ELF Mineral Foundation SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Hangzhou Facecare Cosmetics Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; g/100g N 20181231 52664-005_1a655d52-eed7-40e6-963c-4b5f6becd245 52664-005 HUMAN OTC DRUG ELF Mineral Concealers SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Hangzhou Facecare Cosmetics Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; g/100g N 20181231 52664-006_8cf23594-b31f-49cf-8ccf-4c930ba32c61 52664-006 HUMAN OTC DRUG ELFMineral Blemish Kit Box SULFUR POWDER TOPICAL 20101201 OTC MONOGRAPH FINAL part333D Hangzhou Facecare Cosmetics Co., Ltd. SULFUR 3 g/100g N 20181231 52664-007_22289d96-ab96-436d-9d7c-3a926d49b0e9 52664-007 HUMAN OTC DRUG ELF Zit Zapper SALICYLIC ACID LIQUID TOPICAL 20101201 OTC MONOGRAPH FINAL part358H Hangzhou Facecare Cosmetics Co., Ltd. SALICYLIC ACID 1 g/100g N 20181231 52664-008_b3a6f2cd-f8c0-40c2-b798-863d9d0b1c7e 52664-008 HUMAN OTC DRUG ELF Lip Balm SPF 15 OXYBENZONE CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Hangzhou Facecare Cosmetics Co., Ltd. OXYBENZONE; OCTINOXATE 4.5; 5 g/100g; g/100g N 20181231 52664-009_ef82cb7b-1847-4f0f-82c9-4a383dffb18b 52664-009 HUMAN OTC DRUG ELF Conceler Pencil and Brush SALICYLIC ACID PASTE TOPICAL 20101201 OTC MONOGRAPH FINAL part358H Hangzhou Facecare Cosmetics Co., Ltd. SALICYLIC ACID 2 g/100g N 20181231 52664-010_69da62c0-818c-4787-9649-5fdb3268504f 52664-010 HUMAN OTC DRUG ELF SPF 45 Sunscreen UVA/UVB Protection TITANIUM DIOXIDE POWDER TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Hangzhou Facecare Cosmetics Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 21.25; 17 g/100g; g/100g N 20181231 52667-004_4e75b39f-7fb8-0212-e054-00144ff8d46c 52667-004 HUMAN OTC DRUG 100% Pure Everywhere Sunscreen SPF 30 Zinc Oxide, Titanium Dioxide STICK TOPICAL 20140909 OTC MONOGRAPH NOT FINAL part352 Purity Cosmetics ZINC OXIDE; TITANIUM DIOXIDE 25; 80 mg/g; mg/g N 20181231 52667-005_4e76e036-5a6d-5c06-e054-00144ff8d46c 52667-005 HUMAN OTC DRUG 100% Pure Sweet Mint Lip Balm SPF 15 Zinc Oxide STICK TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 Purity Cosmetics ZINC OXIDE 87 mg/g N 20181231 52667-006_4e77a097-eb23-4d14-e054-00144ff88e88 52667-006 HUMAN OTC DRUG 100% Pure Yerba Mate MIst SPF 30 Zinc Oxide AEROSOL, SPRAY TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 Purity Cosmetics ZINC OXIDE 120 mg/mL N 20181231 52667-007_60dfd123-701f-50ac-e053-2991aa0a692f 52667-007 HUMAN OTC DRUG BB Shade 10 Luminous SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20171220 OTC MONOGRAPH NOT FINAL part352 Purity Cosmetics TITANIUM DIOXIDE; ZINC OXIDE 46; 87 mg/mL; mg/mL N 20181231 52667-008_60dfc330-1207-9f57-e053-2991aa0a5150 52667-008 HUMAN OTC DRUG BB Shade 20 Aglow SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part352 Purity Cosmetics TITANIUM DIOXIDE; ZINC OXIDE 46; 87 mg/mL; mg/mL N 20181231 52667-009_60df8e46-e16f-50b0-e053-2991aa0a38dc 52667-009 HUMAN OTC DRUG BB Shade 30 Radiance SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part352 Purity Cosmetics TITANIUM DIOXIDE; ZINC OXIDE 46; 87 mg/mL; mg/mL N 20181231 52670-550_9dc054aa-bdb5-4f1b-b52f-de093450cec0 52670-550 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 sodium fluoride F 18 INJECTION INTRAVENOUS 20130628 ANDA ANDA203605 Mayo Clinic SODIUM FLUORIDE F-18 91.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 52670-551_61036fd4-db23-4c3c-9db4-63c1a053f7a0 52670-551 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F-18 INJECTION INTRAVENOUS 20130805 ANDA ANDA203612 Mayo Clinic FLUDEOXYGLUCOSE F-18 240 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 52670-552_35625ae4-80db-4493-91ae-edb0b02913bf 52670-552 HUMAN PRESCRIPTION DRUG Ammonia N 13 ammonia n-13 INJECTION, SOLUTION INTRAVENOUS 20130225 ANDA ANDA203321 Mayo Clinic AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 52670-556_59f2fab5-72ca-457c-8220-58a24143ac1d 52670-556 HUMAN PRESCRIPTION DRUG Choline C 11 Choline C-11 INJECTION INTRAVENOUS 20120912 NDA NDA203155 Mayo Clinic CHOLINE C-11 33.1 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 52674-544_bd4aaa28-589a-4831-94a3-306cdb940ab0 52674-544 HUMAN OTC DRUG Gold and Sudsy CHLOROXYLENOL SOAP TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333E Cosgrove Enterprises, Inc. CHLOROXYLENOL 3 mg/mL E 20171231 52675-030_ceaec008-c59e-42c3-bedb-69cc38b43a95 52675-030 HUMAN OTC DRUG SunScreen Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20120514 OTC MONOGRAPH NOT FINAL part352 Crown Products, LLC OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 4; 2.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 52682-022_fc747d22-137d-4131-a1af-2fb8cc06b5e2 52682-022 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20110822 ANDA ANDA040823 Ingenus Pharmaceuticals NJ, LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 52682-023_dc49192a-63f4-4d4a-833c-27ab7f69f4b6 52682-023 HUMAN PRESCRIPTION DRUG Carisoprodol and Aspirin Carisoprodol and Aspirin TABLET ORAL 20110609 ANDA ANDA040832 Ingenus Pharmaceuticals NJ, LLC CARISOPRODOL; ASPIRIN 200; 325 mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE] CIV N 20181231 52682-024_30f5e02d-0fcd-4fec-a594-bfe6733f050c 52682-024 HUMAN PRESCRIPTION DRUG Carisoprodol, Aspirin and Codeine Phosphate Carisoprodol, Aspirin and Codeine Phosphate TABLET ORAL 20170911 ANDA ANDA040860 Ingenus Pharmaceuticals NJ, LLC CARISOPRODOL; ASPIRIN; CODEINE PHOSPHATE 200; 325; 16 mg/1; mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 52682-043_db9ce025-38ca-467d-88a4-66680a1b5485 52682-043 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20150810 ANDA ANDA203808 Ingenus Pharmaceuticals NJ, LLC TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 52682-044_db9ce025-38ca-467d-88a4-66680a1b5485 52682-044 HUMAN PRESCRIPTION DRUG Tinidazole Tinidazole TABLET ORAL 20150810 ANDA ANDA203808 Ingenus Pharmaceuticals NJ, LLC TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 52682-045_262ba9bb-b43a-4242-b355-fc6d036f09d4 52682-045 HUMAN PRESCRIPTION DRUG CARBIDOPA CARBIDOPA TABLET ORAL 20160302 ANDA ANDA205304 Ingenus Pharmaceuticals NJ, LLC CARBIDOPA 25 mg/1 N 20181231 52682-047_9db6a401-17bf-4ccc-a202-24f7b69b4bb7 52682-047 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120921 ANDA ANDA091451 Ingenus Pharmaceuticals NJ, LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 52682-048_3a5f8282-ff82-4deb-8b2e-3e42bc31df53 52682-048 HUMAN PRESCRIPTION DRUG ETHACRYNIC ACID ETHACRYNIC ACID TABLET ORAL 20160705 ANDA ANDA205609 Ingenus Pharmaceuticals NJ, LLC ETHACRYNIC ACID 25 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 52682-054_534700dd-ed21-4381-abbe-300893e0ced7 52682-054 HUMAN PRESCRIPTION DRUG CHLORTHALIDONE CHLORTHALIDONE TABLET ORAL 20170501 ANDA ANDA206904 Ingenus Pharmaceuticals NJ, LLC CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 52682-055_534700dd-ed21-4381-abbe-300893e0ced7 52682-055 HUMAN PRESCRIPTION DRUG CHLORTHALIDONE CHLORTHALIDONE TABLET ORAL 20170501 ANDA ANDA206904 Ingenus Pharmaceuticals NJ, LLC CHLORTHALIDONE 50 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 52682-059_78b3f180-826e-46dd-b145-05b887727703 52682-059 HUMAN PRESCRIPTION DRUG PRIMAQUINE PHOSPHATE PRIMAQUINE PHOSPHATE TABLET, FILM COATED ORAL 20160623 ANDA ANDA206043 Ingenus Pharmaceuticals NJ, LLC PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] N 20181231 52682-061_a9c0e69d-adb2-4fca-9410-c9ae9ccf93ee 52682-061 HUMAN PRESCRIPTION DRUG TETRABENAZINE TETRABENAZINE TABLET ORAL 20170301 ANDA ANDA207682 Ingenus Pharmaceuticals NJ, LLC TETRABENAZINE 25 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20181231 52682-062_a9c0e69d-adb2-4fca-9410-c9ae9ccf93ee 52682-062 HUMAN PRESCRIPTION DRUG TETRABENAZINE TETRABENAZINE TABLET ORAL 20170301 ANDA ANDA207682 Ingenus Pharmaceuticals NJ, LLC TETRABENAZINE 12.5 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20181231 52682-206_3cb67478-1a51-4e7d-a529-79029655f5d9 52682-206 HUMAN OTC DRUG SODIUM BICARBONATE SODIUM BICARBONATE TABLET ORAL 20110124 OTC MONOGRAPH FINAL part331 Mirror Pharmaceuticals LLC SODIUM BICARBONATE 650 mg/1 E 20171231 52682-500_cd12e9b9-250c-47e8-a380-4502a23aef92 52682-500 HUMAN PRESCRIPTION DRUG CEVIMELINE HYDROCHLORIDE CEVIMELINE HYDROCHLORIDE CAPSULE ORAL 20140617 ANDA ANDA203775 Ingenus Pharmaceuticals NJ, LLC CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 52684-0025_36737b3b-9074-4cf7-8bad-7ecbd5c42eff 52684-0025 HUMAN OTC DRUG BioPhenolics Acetylcholine chloride, Acetaldehyde, Apiolum, Ascorbic acid, BHT, Caffeic acid, Candida albicans, Chlorogenic acid, Cinnamic acid, Coniferyl Alcohol, Coumarin, Dopamine, Estrogen, GABA, Gallic acid, Histamine, Indole, L-Dopa, Malvin, Mannan, Melatonin, Menadione, Norepinephrine, Octopamine, Phenylalanine, Phenyli-sothiocyanate, Phlorizin, Piperine, Progesterone, Pyrrole, Quercetin, Rutin, Salsolinol, Serotonin, Taurine, Testosterone, Tryptophan SPRAY ORAL 20120517 UNAPPROVED HOMEOPATHIC BioVeda ACETYLCHOLINE CHLORIDE; ACETALDEHYDE; APIOLE (PARSLEY); ASCORBIC ACID; BUTYLATED HYDROXYTOLUENE; CAFFEIC ACID; CANDIDA ALBICANS; QUINIC ACID; CINNAMIC ACID; CONIFERYL ALCOHOL; COUMARIN; DOPAMINE; ESTRONE; .GAMMA.-AMINOBUTYRIC ACID; GALLIC ACID; HISTAMINE; INDOLE; LEVODOPA; MALVIN; YEAST MANNAN; MELATONIN; MENADIONE; NOREPINEPHRINE; OCTOPAMINE; PHENYLALANINE; PHENYL ISOTHIOCYANATE; PHLORIZIN; PIPERINE; PROGESTERONE; PYRROLE; QUERCETIN; RUTIN; SALSOLINOL; SEROTONIN; TAURINE; TESTOSTERONE; TRYPTOPHAN 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144; 144 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL E 20171231 52684-0026_062d35eb-716d-426a-95d2-3fdf520af584 52684-0026 HUMAN OTC DRUG BioTerrain Plus Anagallis arvensis, Aqua marina, Fucus vesiculosus, Mentha piperita, Rosa damascene, Silica marina, Cuprum metallicum, Ferrum phosphoricum, Fumaricum acidum, Aralia hispida, Chimaphila maculate, Derris pinnata, Hedeoma pulegioides, Ononis spinosa, Physalis alkekengi, Quassia amara, Saccharum officinale, Hydrofluoricum acidum SPRAY ORAL 20120603 UNAPPROVED HOMEOPATHIC BioVeda ANAGALLIS ARVENSIS; WATER; MENTHA PIPERITA; ROSA DAMASCENA FLOWERING TOP; SILICON DIOXIDE; FUCUS VESICULOSUS; COPPER; FERROSOFERRIC PHOSPHATE; ARALIA HISPIDA ROOT; CHIMAPHILA MACULATA; DALBERGIA PINNATA ROOT; HEDEOMA PULEGIOIDES; ONONIS CAMPESTRIS; QUASSIA AMARA WOOD; SUCROSE; HYDROFLUORIC ACID 3; 3; 3; 3; 3; 3; 144; 144; 144; 144; 144; 1; 144; 144; 144; 144 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL E 20171231 52685-191_dc6982b3-31a5-4423-9d95-947ce6e1992a 52685-191 HUMAN OTC DRUG CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES Octinoxate and Titanium dioxide CREAM TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 1160; 2320 mg/40g; mg/40g E 20171231 52685-192_df8c3e06-06df-4abe-8111-bcfd93e6f805 52685-192 HUMAN OTC DRUG CLE DE PEAU BEAUTE SMOOTHING BASE FOR LINES Titanium dioxide CREAM TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 3960 mg/40g E 20171231 52685-300_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-300 HUMAN OTC DRUG CLE DE PEAU BEAUTE BF20 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g E 20171231 52685-301_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-301 HUMAN OTC DRUG CLE DE PEAU BEAUTE I10 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g E 20171231 52685-302_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-302 HUMAN OTC DRUG CLE DE PEAU BEAUTE O10 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g E 20171231 52685-303_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-303 HUMAN OTC DRUG CLE DE PEAU BEAUTE O20 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g E 20171231 52685-304_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-304 HUMAN OTC DRUG CLE DE PEAU BEAUTE O30 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g E 20171231 52685-305_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-305 HUMAN OTC DRUG CLE DE PEAU BEAUTE B10 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g E 20171231 52685-306_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-306 HUMAN OTC DRUG CLE DE PEAU BEAUTE B20 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g E 20171231 52685-307_9720078d-ca93-43ca-bcef-a528bced3ea4 52685-307 HUMAN OTC DRUG CLE DE PEAU BEAUTE B30 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 1.65 mg/11g; g/11g E 20171231 52685-308_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-308 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) I00 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g E 20171231 52685-309_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-309 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) I20 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g E 20171231 52685-310_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-310 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) I40 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g E 20171231 52685-311_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-311 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) I60 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g E 20171231 52685-312_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-312 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) B20 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g E 20171231 52685-313_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-313 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) B40 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g E 20171231 52685-314_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-314 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) B60 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g E 20171231 52685-315_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-315 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) O20 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g E 20171231 52685-316_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-316 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) O40 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g E 20171231 52685-317_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-317 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) O60 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g E 20171231 52685-318_a799694f-3002-4c37-b6f1-6174dd8705e2 52685-318 HUMAN OTC DRUG ADVANCED HYDRO-LIQUID COMPACT (REFILL) O80 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.7 g/12g E 20171231 52685-319_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-319 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I00 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g E 20171231 52685-320_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-320 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I20 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g E 20171231 52685-321_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-321 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I40 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g E 20171231 52685-322_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-322 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I60 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g E 20171231 52685-323_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-323 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B20 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g E 20171231 52685-324_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-324 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B40 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g E 20171231 52685-325_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-325 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B60 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g E 20171231 52685-326_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-326 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O20 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g E 20171231 52685-327_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-327 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O40 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g E 20171231 52685-328_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-328 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O60 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g E 20171231 52685-329_e023dea4-5d92-48db-96ee-e47ae7a28f4f 52685-329 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O80 Octinoxate and Titanium dioxide POWDER TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 1.715 mg/9.8g; g/9.8g E 20171231 52685-330_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-330 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION BF20 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g E 20171231 52685-331_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-331 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION I10 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g E 20171231 52685-332_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-332 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION O10 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g E 20171231 52685-333_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-333 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION O20 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g E 20171231 52685-334_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-334 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION O30 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g E 20171231 52685-335_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-335 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION B10 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g E 20171231 52685-336_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-336 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION B20 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g E 20171231 52685-337_a3c38c20-b6a6-4aa0-b2f4-fa622a660703 52685-337 HUMAN OTC DRUG CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION B30 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 1.896 g/12g E 20171231 52685-338_b0add565-b40b-43c3-8606-19c34c1c8049 52685-338 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I BF20 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g E 20171231 52685-339_b0add565-b40b-43c3-8606-19c34c1c8049 52685-339 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I I10 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g E 20171231 52685-340_b0add565-b40b-43c3-8606-19c34c1c8049 52685-340 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I O10 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g E 20171231 52685-341_b0add565-b40b-43c3-8606-19c34c1c8049 52685-341 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I O20 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g E 20171231 52685-342_b0add565-b40b-43c3-8606-19c34c1c8049 52685-342 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I O30 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g E 20171231 52685-343_b0add565-b40b-43c3-8606-19c34c1c8049 52685-343 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I B10 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g E 20171231 52685-344_b0add565-b40b-43c3-8606-19c34c1c8049 52685-344 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I B20 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g E 20171231 52685-345_b0add565-b40b-43c3-8606-19c34c1c8049 52685-345 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION I B30 Titanium dioxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .65625 g/31.25g E 20171231 52685-346_e375fa1f-32b9-4404-88d6-64d4be68ccb5 52685-346 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I Ensulizole, Octinoxate, Octocrylene, and Oxybenzone CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1.90875; 6.23525; 3.8175; 1.2725 g/127.25g; g/127.25g; g/127.25g; g/127.25g E 20171231 52685-347_d49f5e40-ff3b-441a-9f4d-f949ce22c9f9 52685-347 HUMAN OTC DRUG CLE DE PEAU BEAUTE GENTLE PROTECTIVE I Ensulizole, Octinoxate, Octocrylene, and Oxybenzone CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. ENSULIZOLE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1.92; 6.272; 3.84; 1.28 g/128g; g/128g; g/128g; g/128g E 20171231 52685-348_4310b8bf-0e95-46d5-82e7-8a7778b1f36b 52685-348 HUMAN OTC DRUG SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL) B00 Octinoxate and Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g E 20171231 52685-349_4310b8bf-0e95-46d5-82e7-8a7778b1f36b 52685-349 HUMAN OTC DRUG SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL) B100 Octinoxate and Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g E 20171231 52685-350_4310b8bf-0e95-46d5-82e7-8a7778b1f36b 52685-350 HUMAN OTC DRUG SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL) I00 Octinoxate and Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g E 20171231 52685-351_4310b8bf-0e95-46d5-82e7-8a7778b1f36b 52685-351 HUMAN OTC DRUG SHISEIDO THE MAKEUP SHEER MATIFYING COMPACT (REFILL) O00 Octinoxate and Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g E 20171231 52685-352_8ee4c4ae-431b-4212-ab85-210401a896e5 52685-352 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B00 Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-353_8ee4c4ae-431b-4212-ab85-210401a896e5 52685-353 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B100 Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-354_8ee4c4ae-431b-4212-ab85-210401a896e5 52685-354 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I100 Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-356_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-356 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I BF20 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g E 20171231 52685-357_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-357 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I I10 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g E 20171231 52685-358_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-358 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I O10 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g E 20171231 52685-359_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-359 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I O20 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g E 20171231 52685-360_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-360 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I O30 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g E 20171231 52685-361_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-361 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I B10 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g E 20171231 52685-362_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-362 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I B20 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g E 20171231 52685-363_169db7f3-d203-40a7-a515-0bc2cc6dfb73 52685-363 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I B30 Octinoxate and Titanium dioxide CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .53865; 1.16235 g/28.35g; g/28.35g E 20171231 52685-364_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-364 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s BF20 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g N 20181231 52685-365_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-365 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s I10 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g N 20181231 52685-366_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-366 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s O10 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g N 20181231 52685-367_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-367 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s O20 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g N 20181231 52685-368_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-368 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s O30 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g N 20181231 52685-369_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-369 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s B10 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g N 20181231 52685-370_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-370 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s B20 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g N 20181231 52685-371_577bf1ee-61af-4b07-bd5b-7db2396e35f0 52685-371 HUMAN OTC DRUG CLE DE PEAU BEAUTE PW FOUNDATION s B30 Octinoxate and Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 209; 363 mg/11g; mg/11g N 20181231 52685-372_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-372 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION BF20 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g E 20171231 52685-373_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-373 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION I10 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g E 20171231 52685-374_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-374 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION O10 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g E 20171231 52685-375_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-375 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION O20 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g E 20171231 52685-376_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-376 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION O30 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g E 20171231 52685-377_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-377 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION B10 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g E 20171231 52685-378_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-378 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION B20 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g E 20171231 52685-379_ba7cd809-905c-4b89-bd08-4e61433ecee4 52685-379 HUMAN OTC DRUG CLE DE PEAU BEAUTE CR COMPACT FOUNDATION B30 Titanium dioxide PASTE TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 684 mg/12g E 20171231 52685-380_acc7e724-215c-49b5-b751-511ae370ab44 52685-380 HUMAN OTC DRUG CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER Ensulizole and Octinoxate CREAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. ENSULIZOLE; OCTINOXATE 430; 1054 mg/21.52g; mg/21.52g E 20171231 52685-381_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-381 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION BF20 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g E 20171231 52685-382_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-382 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION I10 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g E 20171231 52685-383_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-383 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O10 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g E 20171231 52685-384_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-384 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O20 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g E 20171231 52685-385_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-385 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O30 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g E 20171231 52685-386_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-386 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION B10 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g E 20171231 52685-387_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-387 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION B20 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g E 20171231 52685-388_a564f100-f982-4a8f-a0d0-e9129fe5c872 52685-388 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION B30 Octinoxate EMULSION TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g E 20171231 52685-391_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-391 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O00 Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-392_8ee4c4ae-431b-4212-ab85-210401a896e5 52685-392 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) WB40 Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-393_8ee4c4ae-431b-4212-ab85-210401a896e5 52685-393 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) WB60 Titanium dioxide POWDER TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-394_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-394 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I00 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-395_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-395 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I20 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-396_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-396 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I40 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-397_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-397 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I60 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-398_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-398 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B20 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-399_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-399 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B40 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-400_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-400 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B60 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-401_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-401 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O20 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-402_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-402 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O40 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-403_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-403 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O60 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-404_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-404 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O80 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-405_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-405 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B00 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-406_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-406 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) B100 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-407_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-407 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) I100 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-408_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-408 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) O00 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-409_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-409 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) WB40 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-410_27326b8e-10ab-4d8b-ad12-3703b40acb37 52685-410 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) WB60 Octinoxate and Titanium dioxide POWDER TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-422_663ef438-339a-48f0-a798-97c2b62ff7de 52685-422 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I00 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g E 20171231 52685-423_663ef438-339a-48f0-a798-97c2b62ff7de 52685-423 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I20 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g E 20171231 52685-424_663ef438-339a-48f0-a798-97c2b62ff7de 52685-424 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I40 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g E 20171231 52685-425_663ef438-339a-48f0-a798-97c2b62ff7de 52685-425 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I60 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g E 20171231 52685-426_663ef438-339a-48f0-a798-97c2b62ff7de 52685-426 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION B20 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g E 20171231 52685-427_663ef438-339a-48f0-a798-97c2b62ff7de 52685-427 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION B40 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g E 20171231 52685-428_663ef438-339a-48f0-a798-97c2b62ff7de 52685-428 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION B60 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g E 20171231 52685-429_663ef438-339a-48f0-a798-97c2b62ff7de 52685-429 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION O20 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g E 20171231 52685-430_663ef438-339a-48f0-a798-97c2b62ff7de 52685-430 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION O40 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g E 20171231 52685-431_663ef438-339a-48f0-a798-97c2b62ff7de 52685-431 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION O60 TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 410 mg/10g E 20171231 52685-432_c328c80b-e64f-4a8a-b2bf-3ec88136a1f2 52685-432 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION Control Color TITANIUM DIOXIDE STICK TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 250 mg/10g E 20171231 52685-433_c81517c8-8d43-4553-a8d3-d14001628773 52685-433 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) I00 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g N 20181231 52685-434_c81517c8-8d43-4553-a8d3-d14001628773 52685-434 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) I20 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g N 20181231 52685-435_c81517c8-8d43-4553-a8d3-d14001628773 52685-435 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) I40 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g N 20181231 52685-436_c81517c8-8d43-4553-a8d3-d14001628773 52685-436 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) I60 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g N 20181231 52685-437_c81517c8-8d43-4553-a8d3-d14001628773 52685-437 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) B20 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g N 20181231 52685-438_c81517c8-8d43-4553-a8d3-d14001628773 52685-438 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) B40 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g N 20181231 52685-439_c81517c8-8d43-4553-a8d3-d14001628773 52685-439 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) B60 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g N 20181231 52685-440_c81517c8-8d43-4553-a8d3-d14001628773 52685-440 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) O20 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g N 20181231 52685-441_c81517c8-8d43-4553-a8d3-d14001628773 52685-441 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) O40 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g N 20181231 52685-442_c81517c8-8d43-4553-a8d3-d14001628773 52685-442 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) O60 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g N 20181231 52685-443_c81517c8-8d43-4553-a8d3-d14001628773 52685-443 HUMAN OTC DRUG SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (Refill) O80 Octinoxate and Titanium dioxide POWDER TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 140; 250 mg/10g; mg/10g N 20181231 52685-444_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-444 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I00 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-445_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-445 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I20 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-446_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-446 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I40 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-447_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-447 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I60 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-448_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-448 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B20 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-449_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-449 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B40 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-450_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-450 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B60 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-451_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-451 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O20 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-452_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-452 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O40 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-453_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-453 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O60 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-454_45c643a6-eb78-457b-92f2-55c47fca99bf 52685-454 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O80 Titanium dioxide POWDER TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE .54 g/12g E 20171231 52685-455_55ac9cc2-74dc-4c0b-8a5a-7f8743063b1a 52685-455 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) D10 Octinoxate and Titanium dioxide POWDER TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-456_55ac9cc2-74dc-4c0b-8a5a-7f8743063b1a 52685-456 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) D20 Octinoxate and Titanium dioxide POWDER TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-457_55ac9cc2-74dc-4c0b-8a5a-7f8743063b1a 52685-457 HUMAN OTC DRUG SHISEIDO SHEER MATIFYING COMPACT (REFILL) D30 Octinoxate and Titanium dioxide POWDER TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 382; 588 mg/9.8g; mg/9.8g N 20181231 52685-458_57007676-ec08-4599-9d6c-7d03a685b982 52685-458 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D10 Titanium dioxide POWDER TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 864 mg/12g E 20171231 52685-459_57007676-ec08-4599-9d6c-7d03a685b982 52685-459 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D20 Titanium dioxide POWDER TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 864 mg/12g E 20171231 52685-460_57007676-ec08-4599-9d6c-7d03a685b982 52685-460 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D30 Titanium dioxide POWDER TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. TITANIUM DIOXIDE 864 mg/12g E 20171231 52685-461_ab52a7bc-9b1b-4103-9f94-57e5370c5236 52685-461 HUMAN OTC DRUG CLE DE PEAU BEAUTE GENTLE PROTECTIVE I AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE EMULSION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3163; 9361; 2530; 1265 mg/126.5g; mg/126.5g; mg/126.5g; mg/126.5g E 20171231 52685-462_cd8f9cae-a9a6-41cf-9d9d-38c5d4d7c989 52685-462 HUMAN OTC DRUG CLE DE PEAU BEAUTE GENTLE PROTECTIVE I AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE EMULSION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3163; 9361; 2530; 1265 mg/126.5g; mg/126.5g; mg/126.5g; mg/126.5g E 20171231 52685-463_2a5ab304-f70b-43a9-bce0-668f1d391170 52685-463 HUMAN OTC DRUG CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 523; 1548; 418 mg/20.92g; mg/20.92g; mg/20.92g E 20171231 52685-464_49e2c3a2-610b-4043-a686-7cb497238126 52685-464 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O40 OCTINOXATE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g E 20171231 52685-465_49e2c3a2-610b-4043-a686-7cb497238126 52685-465 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O50 OCTINOXATE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g E 20171231 52685-466_49e2c3a2-610b-4043-a686-7cb497238126 52685-466 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFINING FLUID FOUNDATION O60 OCTINOXATE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO CO., LTD. OCTINOXATE 1690 mg/34.48g E 20171231 52686-106_d73e6a8d-018b-404c-b626-97738c62cec8 52686-106 HUMAN OTC DRUG BENEFIANCE PROTECTIVE HAND REVITALIZER OCTINOXATE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE 5550 mg/75g N 20181231 52686-134_591e99ff-6d8d-4489-bded-c68b1c930701 52686-134 HUMAN OTC DRUG SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER OCTINOXATE LIPSTICK TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE 196 mg/4g N 20181231 52686-221_cfb1b58a-f158-4159-8659-c6cd46bf9560 52686-221 HUMAN OTC DRUG SHISEIDO Future LX Day/Jour Ensulizole, Octinoxate and Octocrylene CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; OCTOCRYLENE 1.02; 2.5; 2.55 g/51g; g/51g; g/51g N 20181231 52686-222_690625fb-6bfe-4c45-8ab6-fa051ed38acd 52686-222 HUMAN OTC DRUG SHISEIDO SUNCARE EXTRA SMOOTH Octinoxate and Zinc Oxide CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; ZINC OXIDE 4.2; 5.5 g/57g; g/57g N 20181231 52686-223_78b208ea-da61-4034-9f32-233d61dffc48 52686-223 HUMAN OTC DRUG SHISEIDO SUNCARE EXTRA SMOOTH Octinoxate and Zinc Oxide LOTION TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; ZINC OXIDE 6.956; 9.024 g/94g; g/94g N 20181231 52686-224_7ec6b666-12c3-46de-81b2-c51d0200d457 52686-224 HUMAN OTC DRUG SHISEIDO SUNCARE ULTIMATE Octinoxate, Titanium Dioxide, and Zinc Oxide CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.516; .748; 5.542 g/34g; g/34g; g/34g N 20181231 52686-225_d175a9f5-78aa-4e06-8db7-39960edb3075 52686-225 HUMAN OTC DRUG SHISEIDO SUNCARE ULTIMATE Octinoxate, Titanium Dioxide, and Zinc Oxide CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4.218; 1.254; 9.291 g/57g; g/57g; g/57g N 20181231 52686-226_579fc74a-8993-4b78-bf64-78efdb85dcf0 52686-226 HUMAN OTC DRUG SHISEIDO SUNCARE ULTIMATE Ensulizole, Octinoxate, and Zinc Oxide LOTION TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; ZINC OXIDE 1.88; 6.956; 15.322 g/94g; g/94g; g/94g N 20181231 52686-227_1e4b266f-4f72-494f-a186-fa748cd1ea91 52686-227 HUMAN OTC DRUG SHISEIDO WHITE LUCENT Ensulizole, Octinoxate, and Titanium Dioxide CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 1.275; 3.774; .969 g/51g; g/51g; g/51g N 20181231 52686-228_c7a40719-a7da-4fe4-b638-a6104d05bd25 52686-228 HUMAN OTC DRUG SHISEIDO WHITE LUCENT Octinoxate and Octocrylene EMULSION TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE 3.479; 3.55 g/71g; g/71g N 20181231 52686-229_9ba056c5-67bc-4929-a7a0-6a118b371934 52686-229 HUMAN OTC DRUG SHISEIDO MAKEUP REFINING MAKEUP PRIMER Octinoxate and Titanium dioxide CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1.528016; 2.3388 g/31.184g; g/31.184g N 20181231 52686-230_2ff82d9f-eb5a-4de2-93ea-9de6d47936c3 52686-230 HUMAN OTC DRUG SHISEIDO BENEFIANCE WRINKLERESIST24 DAY Octinoxate and Octocrylene CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE 2.51125; 2.5625 g/51.25g; g/51.25g N 20181231 52686-231_ef81e918-4913-4f9d-b3cc-e286867f301b 52686-231 HUMAN OTC DRUG SHISEIDO BENEFIANCE WRINKLERESIST24 DAY Octinoxate and Octocrylene EMULSION TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE 3.81465; 3.8925 g/77.85g; g/77.85g N 20181231 52686-232_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-232 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION I00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-233_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-233 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION I20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-234_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-234 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION I40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-235_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-235 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION I60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-236_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-236 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION I100 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-237_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-237 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION B00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-238_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-238 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-239_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-239 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION B40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-240_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-240 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION B60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-241_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-241 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION B100 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-242_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-242 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION O00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-243_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-243 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-244_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-244 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-245_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-245 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-246_d1ee49ae-527e-467f-b974-3a5c5ef996d2 52686-246 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION O80 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .63555; 1.37145 g/33.45g; g/33.45g N 20181231 52686-249_f8382ceb-2d81-4391-a305-f1d882ff8481 52686-249 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV IVORY OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .9396; 2.7216 g/32.4g; g/32.4g N 20181231 52686-250_f8382ceb-2d81-4391-a305-f1d882ff8481 52686-250 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV GREEN OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .9396; 2.7216 g/32.4g; g/32.4g N 20181231 52686-251_f8382ceb-2d81-4391-a305-f1d882ff8481 52686-251 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV PINK OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .9396; 2.7216 g/32.4g; g/32.4g N 20181231 52686-252_e0089017-8514-4659-afd8-a4a964a2bf6c 52686-252 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O00 OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .39; .66 g/10g; g/10g N 20181231 52686-253_e0089017-8514-4659-afd8-a4a964a2bf6c 52686-253 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O20 OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .39; .66 g/10g; g/10g N 20181231 52686-254_e0089017-8514-4659-afd8-a4a964a2bf6c 52686-254 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O40 OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .39; .66 g/10g; g/10g N 20181231 52686-255_e0089017-8514-4659-afd8-a4a964a2bf6c 52686-255 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O60 OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .39; .66 g/10g; g/10g N 20181231 52686-256_e0089017-8514-4659-afd8-a4a964a2bf6c 52686-256 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) BF20 OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .39; .66 g/10g; g/10g N 20181231 52686-257_e0089017-8514-4659-afd8-a4a964a2bf6c 52686-257 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) I00 OCTINOXATE and TITANIUM DIOXIDE PASTE TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE .39; .66 g/10g; g/10g N 20181231 52686-258_b0a71b44-8e42-4ef1-b343-89ee66e70302 52686-258 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR Octinoxate, Octocrylene, and Zinc Oxide EMULSION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 2.27; .92; 2.64 g/30.66g; g/30.66g; g/30.66g N 20181231 52686-259_177f1296-f84a-40f1-9b0a-77d3f5f70649 52686-259 HUMAN OTC DRUG CLE DE PEAU BEAUTE UV PROTECTION Octinoxate, Octocrylene, Oxybenzone, and Zinc oxide CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 4.06; 1.65; .82; 4.94 g/54.91g; g/54.91g; g/54.91g; g/54.91g N 20181231 52686-260_46686efd-64b6-42a9-a329-ddedd0141ce5 52686-260 HUMAN OTC DRUG SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 1 LIGHT Octinoxate and Titanium Dioxide CREAM TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1149; 7556 mg/60.45g; mg/60.45g N 20181231 52686-261_46686efd-64b6-42a9-a329-ddedd0141ce5 52686-261 HUMAN OTC DRUG SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 2 MEDIUM Octinoxate and Titanium Dioxide CREAM TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1149; 7556 mg/60.45g; mg/60.45g N 20181231 52686-262_46686efd-64b6-42a9-a329-ddedd0141ce5 52686-262 HUMAN OTC DRUG SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 3 MEDIUM DEEP Octinoxate and Titanium Dioxide CREAM TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1149; 7556 mg/60.45g; mg/60.45g N 20181231 52686-263_46686efd-64b6-42a9-a329-ddedd0141ce5 52686-263 HUMAN OTC DRUG SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 4 DEEP Octinoxate and Titanium Dioxide CREAM TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1149; 7556 mg/60.45g; mg/60.45g N 20181231 52686-264_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-264 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP10 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g N 20181231 52686-265_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-265 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP20 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g N 20181231 52686-266_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-266 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP30 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g N 20181231 52686-267_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-267 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP40 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g N 20181231 52686-268_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-268 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP50 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g N 20181231 52686-269_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-269 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP60 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g N 20181231 52686-270_4bbb3c07-5fb8-4257-a17a-f52689ae3b2f 52686-270 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION SP70 TITANIUM DIOXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. TITANIUM DIOXIDE 1488 mg/36.3g N 20181231 52686-271_da8aac41-04d7-49c0-8440-ebc4ce944f50 52686-271 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT UV PROTECTION OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1583; 1638; 5788 mg/54.6g; mg/54.6g; mg/54.6g N 20181231 52686-272_89dd0490-cade-4a7a-8e51-6c06a3be8df3 52686-272 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1557; 953; 3971 mg/31.77g; mg/31.77g; mg/31.77g N 20181231 52686-273_7a2b9caa-0474-4ea6-8030-041a3a06cc60 52686-273 HUMAN OTC DRUG SHISEIDO ULTIMATE SUN PROTECTION PLUS OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 4503; 1826; 1034; 11.74 g/60.85g; g/60.85g; mg/60.85g; g/60.85g N 20181231 52686-274_0942ab93-e0f4-43a9-a395-87b72da6e95b 52686-274 HUMAN OTC DRUG SHISEIDO ULTIMATE SUN PROTECTION PLUS OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 8673; 3516; 1992; 22.62 mg/100mL; mg/100mL; mg/100mL; g/100mL N 20181231 52686-275_5719a5e5-71d4-4300-9d59-f9c0e7ee655c 52686-275 HUMAN OTC DRUG CLE DE PEAU BEAUTE UV PROTECTION OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 4348; 1763; 9635 mg/58.75g; mg/58.75g; mg/58.75g N 20181231 52686-276_e166930e-098e-43a0-8835-59a1844bf9ec 52686-276 HUMAN OTC DRUG SHISEIDO REFINING MAKEUP PRIMER OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1661; 2509 mg/33.9g; mg/33.9g N 20181231 52686-277_4443bb6a-acb3-49f8-9059-b1ba524ab13b 52686-277 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION D10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 983; 1966 mg/33.9g; mg/33.9g N 20181231 52686-278_4443bb6a-acb3-49f8-9059-b1ba524ab13b 52686-278 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION D20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 983; 1966 mg/33.9g; mg/33.9g N 20181231 52686-279_4443bb6a-acb3-49f8-9059-b1ba524ab13b 52686-279 HUMAN OTC DRUG SHISEIDO PERFECT REFINING FOUNDATION D30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 983; 1966 mg/33.9g; mg/33.9g N 20181231 52686-280_87d5cf03-f5a3-4cb1-b183-4a2e63814f96 52686-280 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING PROTECTIVE W AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1284; 3800; 1027 mg/51.35g; mg/51.35g; mg/51.35g N 20181231 52686-281_6e368a8b-9d46-447c-9c35-97a53c30e842 52686-281 HUMAN OTC DRUG SHISEIDO WHITE LUCENT BRIGHTENING PROTECTIVE W AVOBENZONE, OCTINOXATE, and OCTOCRYLENE EMULSION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1915; 5667; 1532 mg/76.58g; mg/76.58g; mg/76.58g N 20181231 52686-282_06afa6db-cbeb-4640-882c-9e3c9a7d079b 52686-282 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION BEIGE OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 261; 414 mg/9g; mg/9g N 20181231 52686-283_06afa6db-cbeb-4640-882c-9e3c9a7d079b 52686-283 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION OCHRE OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 261; 414 mg/9g; mg/9g N 20181231 52686-284_34826613-d02f-4f03-b159-d59e967e9c98 52686-284 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION I00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g N 20181231 52686-285_34826613-d02f-4f03-b159-d59e967e9c98 52686-285 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION I20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g N 20181231 52686-286_34826613-d02f-4f03-b159-d59e967e9c98 52686-286 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION I40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g N 20181231 52686-287_34826613-d02f-4f03-b159-d59e967e9c98 52686-287 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION I60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g N 20181231 52686-288_34826613-d02f-4f03-b159-d59e967e9c98 52686-288 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g N 20181231 52686-289_34826613-d02f-4f03-b159-d59e967e9c98 52686-289 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION B40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g N 20181231 52686-290_34826613-d02f-4f03-b159-d59e967e9c98 52686-290 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION B60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g N 20181231 52686-291_34826613-d02f-4f03-b159-d59e967e9c98 52686-291 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g N 20181231 52686-292_34826613-d02f-4f03-b159-d59e967e9c98 52686-292 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g N 20181231 52686-293_34826613-d02f-4f03-b159-d59e967e9c98 52686-293 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g N 20181231 52686-294_34826613-d02f-4f03-b159-d59e967e9c98 52686-294 HUMAN OTC DRUG SHISEIDO THE MAKEUP LIFTING FOUNDATION O80 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 979; 1486 mg/33.77g; mg/33.77g N 20181231 52686-295_6c038d6c-963c-450d-a823-94fdbc524f84 52686-295 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP10 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g N 20181231 52686-296_6c038d6c-963c-450d-a823-94fdbc524f84 52686-296 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP20 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g N 20181231 52686-297_6c038d6c-963c-450d-a823-94fdbc524f84 52686-297 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP30 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g N 20181231 52686-298_6c038d6c-963c-450d-a823-94fdbc524f84 52686-298 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP40 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g N 20181231 52686-299_6c038d6c-963c-450d-a823-94fdbc524f84 52686-299 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP50 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g N 20181231 52686-300_6c038d6c-963c-450d-a823-94fdbc524f84 52686-300 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP60 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g N 20181231 52686-301_6c038d6c-963c-450d-a823-94fdbc524f84 52686-301 HUMAN OTC DRUG SHISEIDO SUN PROTECTION COMPACT FOUNDATION (REFILL) SP70 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 828; 660 mg/12g; mg/12g N 20181231 52686-302_217c07d3-02c9-4bcb-91b1-ce9e0522a77e 52686-302 HUMAN OTC DRUG SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 10 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 209; 198 mg/11g; mg/11g N 20181231 52686-303_217c07d3-02c9-4bcb-91b1-ce9e0522a77e 52686-303 HUMAN OTC DRUG SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 20 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 209; 198 mg/11g; mg/11g N 20181231 52686-304_217c07d3-02c9-4bcb-91b1-ce9e0522a77e 52686-304 HUMAN OTC DRUG SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 30 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 209; 198 mg/11g; mg/11g N 20181231 52686-305_217c07d3-02c9-4bcb-91b1-ce9e0522a77e 52686-305 HUMAN OTC DRUG SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 40 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 209; 198 mg/11g; mg/11g N 20181231 52686-306_217c07d3-02c9-4bcb-91b1-ce9e0522a77e 52686-306 HUMAN OTC DRUG SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 50 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 209; 198 mg/11g; mg/11g N 20181231 52686-307_217c07d3-02c9-4bcb-91b1-ce9e0522a77e 52686-307 HUMAN OTC DRUG SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL) 60 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20020901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 209; 198 mg/11g; mg/11g N 20181231 52686-308_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-308 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION I00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-309_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-309 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION I20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-310_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-310 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION I40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-311_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-311 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION I60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-312_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-312 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION I100 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-313_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-313 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION B00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-314_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-314 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-315_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-315 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION B40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-316_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-316 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION B60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-317_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-317 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION B100 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-318_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-318 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION O00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-319_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-319 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-320_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-320 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-321_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-321 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-322_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-322 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION O80 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-323_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-323 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION BF40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-324_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-324 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION WB40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-325_129b9ca5-2683-4f11-aa5c-c9765ac854f7 52686-325 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION WB60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 682; 1471 mg/35.88g; mg/35.88g N 20181231 52686-326_9b7b250e-c2b5-4a95-9d87-3054f762c3ba 52686-326 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION D10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1220; 2081 mg/35.88g; mg/35.88g N 20181231 52686-327_9b7b250e-c2b5-4a95-9d87-3054f762c3ba 52686-327 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION D20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1220; 2081 mg/35.88g; mg/35.88g N 20181231 52686-328_9b7b250e-c2b5-4a95-9d87-3054f762c3ba 52686-328 HUMAN OTC DRUG SHISEIDO RADIANT LIFTING FOUNDATION D30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 1220; 2081 mg/35.88g; mg/35.88g N 20181231 52686-329_2dab2b8a-a3fc-4aa0-af7d-7b058eed5722 52686-329 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX DAYTIME PROTECTIVE AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1255; 3715; 1004 mg/50.2g; mg/50.2g; mg/50.2g N 20181231 52686-330_062eaceb-a0d3-43f0-9724-79a7cce3feb8 52686-330 HUMAN OTC DRUG SHISEIDO BENEFIANCE WRINKLERESIST24 DAY AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1289; 3815; 1031 mg/51.55g; mg/51.55g; mg/51.55g N 20181231 52686-331_3ca083a5-8a34-4948-8040-9ce795929e80 52686-331 HUMAN OTC DRUG SHISEIDO BENEFIANCE WRINKLERESIST24 DAY AVOBENZONE, OCTINOXATE, and OCTOCRYLENE EMULSION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1946; 5761; 1557 mg/77.85g; mg/77.85g; mg/77.85g N 20181231 52686-332_4c15673e-85db-4cb5-9377-4c04e38d37be 52686-332 HUMAN OTC DRUG SHISEIDO BENEFIANCE NUTRIPERFECT DAY AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1286; 3807; 1029 mg/51.45g; mg/51.45g; mg/51.45g N 20181231 52686-333_d84fe903-2eee-4f57-9188-a8917e3dceb6 52686-333 HUMAN OTC DRUG SHISEIDO THE SKINCARE DAY MOISTURE PROTECTION AVOBENZONE, OCTINOXATE, and OCTOCRYLENE EMULSION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1935; 5728; 1548 mg/77.4g; mg/77.4g; mg/77.4g N 20181231 52686-334_5f40b504-9e2e-4e63-8416-4b64345f8f28 52686-334 HUMAN OTC DRUG SHISEIDO THE SKINCARE DAY MOISTURE PROTECTION ENRICHED AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1316; 3896; 1053 mg/52.65g; mg/52.65g; mg/52.65g N 20181231 52686-335_0801ab22-8145-4711-b95c-3b786b1ceafb 52686-335 HUMAN OTC DRUG SHISEIDO SUN PROTECTION EYE OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 479; 495; 1749 mg/16.5g; mg/16.5g; mg/16.5g N 20181231 52686-336_afa33e91-1c60-42ce-a5f2-ccd6b966e05f 52686-336 HUMAN OTC DRUG SHISEIDO EXTRA SMOOTH SUN PROTECTION N OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 2766; 1694; 7056 mg/56.45g; mg/56.45g; mg/56.45g N 20181231 52686-337_307eba82-c1c2-4c3f-8c26-ceaff8060262 52686-337 HUMAN OTC DRUG SHISEIDO EXTRA SMOOTH SUN PROTECTION N OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 5424; 3321; 13.84 mg/110.7g; mg/110.7g; g/110.7g N 20181231 52686-338_cb5b83cb-1075-4be4-b3bd-160db02ffa79 52686-338 HUMAN OTC DRUG SHISEIDO SUN PROTECTION FOUNDATION TRANSLUCENT OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 441; 828 mg/9g; mg/9g N 20181231 52686-339_d6a8c338-83d7-49e8-a66b-4f9014cc5bba 52686-339 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 1 ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 656; 2426; 2361 mg/32.79g; mg/32.79g; mg/32.79g N 20181231 52686-340_d6a8c338-83d7-49e8-a66b-4f9014cc5bba 52686-340 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 2 ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 656; 2426; 2361 mg/32.79g; mg/32.79g; mg/32.79g N 20181231 52686-341_d6a8c338-83d7-49e8-a66b-4f9014cc5bba 52686-341 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT TINTED UV PROTECTOR 3 ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 656; 2426; 2361 mg/32.79g; mg/32.79g; mg/32.79g N 20181231 52686-342_72150c68-0cc5-4be8-9c6f-626499f72721 52686-342 HUMAN OTC DRUG SHISEIDO PERFECT HYDRATING BB MEDIUM ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 656; 2426; 2361 mg/32.79g; mg/32.79g; mg/32.79g N 20181231 52686-343_72150c68-0cc5-4be8-9c6f-626499f72721 52686-343 HUMAN OTC DRUG SHISEIDO PERFECT HYDRATING BB DARK ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 656; 2426; 2361 mg/32.79g; mg/32.79g; mg/32.79g N 20181231 52686-344_72150c68-0cc5-4be8-9c6f-626499f72721 52686-344 HUMAN OTC DRUG SHISEIDO PERFECT HYDRATING BB LIGHT ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 656; 2426; 2361 mg/32.79g; mg/32.79g; mg/32.79g N 20181231 52686-642_911a6e32-89eb-435f-87a2-ec754a627e73 52686-642 HUMAN OTC DRUG SHISEIDO SUN PROTECTION LIP TREATMENT OCTINOXATE and TITANIUM DIOXIDE LIPSTICK TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; TITANIUM DIOXIDE 296; 180 mg/4g; mg/4g N 20181231 52686-677_b976cc21-abd7-4233-981a-65373e19b3d0 52686-677 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT UV PROTECTION Octinoxate, Octocrylene, and Zinc oxide CREAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 2.50047; 1.5309; 3.41901 g/51.03g; g/51.03g; g/51.03g N 20181231 52686-677_f120e363-3b4b-41be-ad9d-b4af8c93d4e4 52686-677 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT UV PROTECTION Octinoxate, Octocrylene, and Zinc oxide CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 2.50047; 1.5309; 3.41901 g/51.03g; g/51.03g; g/51.03g N 20181231 52695-001_3459b2b1-71cf-4ca0-b870-508e453aa5dd 52695-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19540101 NDA NDA205865 Humphries, Inc. OXYGEN 995 mL/L N 20181231 52695-002_1f3474af-f51b-4504-abd7-05eb86c5aa77 52695-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20180101 NDA NDA205866 Humphries, Inc. NITROGEN 99 L/L N 20191231 52698-001_037b900c-8574-4ba5-99eb-2e83e310f980 52698-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900101 NDA NDA205849 Bill Munn Supply, Inc. OXYGEN 99 L/100L N 20181231 52698-002_9df7cc95-67eb-45dd-94b5-9bf6cc55cde4 52698-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Bill Munn Supply Inc, dba Munn Supply NITROGEN 99 L/100L E 20171231 52709-0801_531816c2-24fb-4ea2-a9dc-b02df0da7847 52709-0801 STANDARDIZED ALLERGENIC Honey Bee Venom APIS MELLIFERA VENOM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19921120 BLA BLA103969 ALK-Abello A S APIS MELLIFERA VENOM 100 ug/mL E 20171231 52709-0901_531816c2-24fb-4ea2-a9dc-b02df0da7847 52709-0901 STANDARDIZED ALLERGENIC Yellow Jacket Venom Protein VESPULA VULGARIS VENOM PROTEIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19921120 BLA BLA103974 ALK-Abello A S VESPULA VULGARIS VENOM PROTEIN 100 ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 52709-1001_531816c2-24fb-4ea2-a9dc-b02df0da7847 52709-1001 STANDARDIZED ALLERGENIC Yellow Hornet Venom Protein DOLICHOVESPULA ARENARIA VENOM PROTEIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19921120 BLA BLA103973 ALK-Abello A S DOLICHOVESPULA ARENARIA VENOM PROTEIN 100 ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 52709-1101_531816c2-24fb-4ea2-a9dc-b02df0da7847 52709-1101 STANDARDIZED ALLERGENIC White Faced Hornet Venom Protein DOLICHOVESPULA MACULATA VENOM PROTEIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19921120 BLA BLA103972 ALK-Abello A S DOLICHOVESPULA MACULATA VENOM PROTEIN 100 ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 52709-1201_531816c2-24fb-4ea2-a9dc-b02df0da7847 52709-1201 STANDARDIZED ALLERGENIC Mixed Vespid Venom VESPULA VULGARIS VENOM PROTEIN, DOLICHOVESPULA ARENARIA VENOM PROTEIN and DOLICHOVESPULA MACULATA VENOM PROTEIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19921120 BLA BLA103970 ALK-Abello A S VESPULA VULGARIS VENOM PROTEIN; DOLICHOVESPULA ARENARIA VENOM PROTEIN; DOLICHOVESPULA MACULATA VENOM PROTEIN 100; 100; 100 ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 52709-1301_531816c2-24fb-4ea2-a9dc-b02df0da7847 52709-1301 STANDARDIZED ALLERGENIC Wasp Venom Protein POLISTES FUSCATUS VENOM PROTEIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19921120 BLA BLA103971 ALK-Abello A S POLISTES FUSCATUS VENOM PROTEIN 100 ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] E 20171231 52709-1501_9291cbc6-d7d6-427d-a2a4-2237aca1e6e9 52709-1501 STANDARDIZED ALLERGENIC GRASTEK Timothy Grass Pollen Allergen Extract TABLET SUBLINGUAL 20140411 BLA BLA125473 ALK-Abelló A/S PHLEUM PRATENSE POLLEN 2800 [BAU]/1 Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 52709-1601_c575148d-1cd5-4484-82a1-06183d2518d6 52709-1601 STANDARDIZED ALLERGENIC RAGWITEK AMBROSIA ARTEMISIIFOLIA POLLEN TABLET SUBLINGUAL 20140417 BLA BLA125478 ALK-Abelló A/S AMBROSIA ARTEMISIIFOLIA POLLEN 12 [Amb'a'1'U]/1 Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 52709-1701_07ba5458-48c1-4a2b-a701-bf5efd048926 52709-1701 STANDARDIZED ALLERGENIC Odactra DERMATOPHAGOIDES PTERONYSSINUS and DERMATOPHAGOIDES FARINAE TABLET SUBLINGUAL 20180101 BLA BLA125592 ALK-Abelló A/S DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE 6; 6 [arb'U]/1; [arb'U]/1 Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20191231 52725-490_986c60c0-7d75-11e0-b654-0002a5d5c51b 52725-490 HUMAN PRESCRIPTION DRUG Fenoglide fenofibrate TABLET ORAL 20101118 NDA NDA022118 Shore Therapeutics, Inc FENOFIBRATE 40 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 52725-495_986c60c0-7d75-11e0-b654-0002a5d5c51b 52725-495 HUMAN PRESCRIPTION DRUG Fenoglide fenofibrate TABLET ORAL 20101118 NDA NDA022118 Shore Therapeutics, Inc FENOFIBRATE 120 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 52726-4083_60f5e30e-505f-0a62-e053-2991aa0a9d66 52726-4083 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 NDA NDA206023 Mercy Home Respiratory Care and Medical Supply OXYGEN 99 L/100L N 20181231 52731-7001_141be593-4a9b-41b9-9f36-985a58b38144 52731-7001 HUMAN OTC DRUG Flu Complex Aconitum napellus, Belladonna, Bryonia, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Phosphorus, Phytolacca decandra, Veratrum viride LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; VERATRUM VIRIDE ROOT 4; 6; 4; 4; 8; 12; 6; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7002_b0a40991-b9be-4194-b3f4-9fba1292e267 52731-7002 HUMAN OTC DRUG Cold Complex Aconitum napellus, Apis mellifica, Belladonna, Calcarea carbonica, Echinacea angustifolia, Euphorbium officinarum, Kali bichronicum, Natrum muriaticum, Nux vomica, Pulsatilla LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ECHINACEA ANGUSTIFOLIA; EUPHORBIA RESINIFERA RESIN; POTASSIUM DICHROMATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS 4; 4; 6; 8; 4; 6; 6; 12; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7003_c29317f3-0231-417a-9874-cf1ad13244a2 52731-7003 HUMAN OTC DRUG Sinus Complex Antimonium tartaricum, Echinacea angustifolia, Euphorbium officinarum, Hepar sulphuris calcareum, Hepatica tribola, Hydrastis canadensis, Mercurius sulfuratus ruber, Natrum muriaticum, Phosphorus LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ANTIMONY POTASSIUM TARTRATE; ECHINACEA ANGUSTIFOLIA; EUPHORBIA RESINIFERA RESIN; CALCIUM SULFIDE; HEPATICA NOBILIS VAR. OBTUSA; GOLDENSEAL; MERCURIC SULFIDE; SODIUM CHLORIDE; PHOSPHORUS 6; 4; 6; 8; 4; 4; 10; 12; 12 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7004_eb65a6a0-ea22-47b6-b99a-465efddc0022 52731-7004 HUMAN OTC DRUG Throat Complex Ammonium carbonicum, Apis mellifica, Arum maculatum, Baryta carbonica, Bromium, Hepar sulphuris calcareum, Lachesis mutus, Mercurius cyanatus, Phytolacca decandra LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. AMMONIUM CARBONATE; APIS MELLIFERA; ARUM MACULATUM ROOT; BARIUM CARBONATE; BROMINE; CALCIUM SULFIDE; LACHESIS MUTA VENOM; MERCURIC CYANIDE; PHYTOLACCA AMERICANA ROOT 6; 4; 4; 10; 6; 8; 10; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7005_b5118f88-1dcd-4dc7-9488-3a1cff4bb584 52731-7005 HUMAN OTC DRUG Respiratory Complex Antimonium tartaricum, Bryonia, Chelidonium majus, Echinacea angustifolia, Hepar sulphuris calcareum, Hepatica tribola, Lycopodium clavatum, Phosphorus, Stannum metallicum, Sticta pulmonaria LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; HEPATICA NOBILIS VAR. OBTUSA; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TIN; LOBARIA PULMONARIA 6; 4; 6; 4; 8; 4; 6; 12; 8; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7006_80b26a64-a12d-4936-84e8-e592452669ed 52731-7006 HUMAN OTC DRUG Asthma Complex Berberis vulgaris, Cactus grandiflorus, Carbo vegetabilis, Chelidonium majus, Cuprum aceticum, Curare, Dulcamara, Ignatia amara, Strophanthus hispidus LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. BERBERIS VULGARIS FRUIT; SELENICEREUS GRANDIFLORUS FLOWER; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CUPRIC ACETATE; TUBOCURARINE CHLORIDE; SOLANUM DULCAMARA TOP; STRYCHNOS IGNATII SEED; STROPHANTHUS HISPIDUS SEED 6; 4; 12; 6; 4; 12; 6; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7007_fc491732-e324-43b4-8e60-164c5d3ed820 52731-7007 HUMAN OTC DRUG Allergy Complex Apis mellifica, Arundo mauritanica, Euphorbium officinarum, Euphrasia officinalis, Hydrastis canadensis, Ipecacuanha, Luffa operculata, Sabadilla, Sanguinaria canadensis, Sulfur LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. APIS MELLIFERA; ARUNDO PLINIANA ROOT; EUPHORBIA RESINIFERA RESIN; EUPHRASIA STRICTA; GOLDENSEAL; IPECAC; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED; SANGUINARIA CANADENSIS ROOT; SULFUR 4; 6; 6; 6; 4; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7008_29d40708-cf65-4c84-bd0c-0d62858ae8a8 52731-7008 HUMAN OTC DRUG Ear Complex Belladonna, Calcarea carbonica, Chamomilla, Echinacea angustifolia, Ferrum phosphoricum, Hepar sulphuris calcareum, Mercurius solubilis, Pulsatilla LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS 6; 8; 6; 4; 8; 8; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7009_277a100d-4bf6-426b-bc88-244e52263e21 52731-7009 HUMAN OTC DRUG Teething Complex Belladonna, Calcarea carbonica, Calcarea fluorica, Chamomilla, Ferrum phosphoricum, Kreosotum, Podophyllum peltatum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; MATRICARIA RECUTITA; FERRUM PHOSPHORICUM; WOOD CREOSOTE; PODOPHYLLUM 12; 12; 12; 4; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7010_5e059829-b0ca-468a-b60a-b71f80025fe4 52731-7010 HUMAN OTC DRUG Depression Complex Arsenicum album, Aurum metallicum, Ignatia amara, Kali phosphoricum, Phosforicum acidum, Pulsatilla, Rhus toxicodendron LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ARSENIC TRIOXIDE; GOLD; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; PHOSPHORIC ACID; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF 12; 12; 12; 12; 12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 52731-7011_6514aa3a-35ec-43eb-81b4-3043c1f0985f 52731-7011 HUMAN OTC DRUG Stress Complex Anacardium orientale, Berberis vulgaris, Natrum muriaticum, Nitricum acidum, Nux vomica, Staphysagria, Sulphur, Thuja occidentalis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. SEMECARPUS ANACARDIUM JUICE; BERBERIS VULGARIS ROOT BARK; SODIUM CHLORIDE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 52731-7012_b51ca425-9ff5-4eb1-a91a-660cef13fe12 52731-7012 HUMAN OTC DRUG Headache Complex Aconitum napellus, Bryonia, Cactus grandiflorus, Chelidonium majus, Cimicifuga racemosa, Sanguinaria canadensis, Spigelia anthelmia, Thuja occidentails LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; SELENICEREUS GRANDIFLORUS STEM; CHELIDONIUM MAJUS; BLACK COHOSH; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 4; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7014_0d52cbf3-1962-4ee4-8aae-091a0397b417 52731-7014 HUMAN OTC DRUG Cough Complex Antimonium tartaricum, Belladonna, Bryonia,Causticum, Coccus cacti, Cuprum aceticum, Drosera rotundifolia, Kreosotum, Lobelia inflata, Pulsatilla, Stannum metallicum, Sticta pulmonaria LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAUSTICUM; PROTORTONIA CACTI; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; WOOD CREOSOTE; LOBELIA INFLATA; PULSATILLA VULGARIS; TIN; LOBARIA PULMONARIA 4; 4; 4; 6; 4; 4; 6; 6; 3; 4; 8; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7015_61e7dc9b-0c71-4a4c-8ce2-804635196890 52731-7015 HUMAN OTC DRUG Diarrhea Complex Aloe socotrina, Arsenicum album, Bryonia, Collinsonia canadensis, Colocynthis, Croton tiglium, Cuprum aceticum, Echinacea angustifolia, Mercurius sub. corros, Rheum officinale, Sulfur, Veratrum album LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ACETATE; ECHINACEA ANGUSTIFOLIA; MERCURIC CHLORIDE; RHEUM OFFICINALE ROOT; SULFUR; VERATRUM ALBUM ROOT 4; 6; 4; 3; 4; 4; 4; 3; 6; 3; 8; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7016_36a06a39-7cb7-41c7-8c95-d6a7cd0b26f2 52731-7016 HUMAN OTC DRUG Exhaustion Complex Berberis vulgaris, China officinalis, Kali phosphoricum, Nux vomica, Picricum acidum, Stannum metallicum, Zincum metallicum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. BERBERIS VULGARIS ROOT BARK; CINCHONA PUBESCENS BARK; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; TRINITROPHENOL; TIN; ZINC 4; 4; 12; 12; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7017_2d344902-2fc3-4447-b08e-30967b3986b7 52731-7017 HUMAN OTC DRUG Hemorrhoid Complex Aesculus hippocastanum, Aloe socotrina, Apis mellifica, Bryonia, Calcarea fluorica, Carbo vegetabilis, Causticum, Collinsonia canadensis, Echinacea angustifolia, Hamamelis virginiana, Lycopodium clavatum, Sulphur LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. HORSE CHESTNUT; ALOE; APIS MELLIFERA; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; ACTIVATED CHARCOAL; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LYCOPODIUM CLAVATUM SPORE; SULFUR 3; 4; 4; 4; 8; 10; 6; 3; 3; 3; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7018_0d052c7e-ad3f-41f7-a29f-6159000a9d5b 52731-7018 HUMAN OTC DRUG Indigestion Complex Alumina, Anacardium orientale, Atropinum sulphuricum, Berberis vulgaris, Capsicum annuum, Carbo vegetabilis, Ignatia amara, Lycopodium clavatum, Nux vomica, Robinia pseud., Sulphuricum acidum, Valeriana officinalis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ALUMINUM OXIDE; SEMECARPUS ANACARDIUM JUICE; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; CAPSICUM; ACTIVATED CHARCOAL; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID; VALERIAN 8; 6; 6; 4; 4; 10; 6; 4; 4; 4; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7019_cfd72d71-8db2-4e7e-b8e5-da24787cc8ee 52731-7019 HUMAN OTC DRUG Injury/Trauma Complex Aesculus hippocastanum, Apis mellifica, Arnica montana, Bellis perennis, Berberis vulgaris, Calendula officinalis, Echinacea angustifolia, Hamamelis virginiana, Hypericum perforatum, Millefolium, Ruta graveolens, Symphytum officinale LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. HORSE CHESTNUT; APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY LEAF 4; 4; 3; 3; 4; 3; 3; 3; 3; 3; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7020_552509d3-3b35-4ea8-ae8a-cdffb8de0c72 52731-7020 HUMAN OTC DRUG PMS Complex Apis mellifica, Atropinum sulphuricum, Calcarea carbonica, Caulophyllum thalictroides, Colocynthis, Cuprum aceticum, Gelsemium sempervirens, Hamamelis virginiana, Helonias Dioica, Ignatia amara, Nux vomica, Pulsatilla, Stannum metalicum, Viburnum opulus LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. APIS MELLIFERA; ATROPINE SULFATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAULOPHYLLUM THALICTROIDES ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC ACETATE; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TIN; VIBURNUM OPULUS BARK 4; 6; 12; 4; 4; 4; 4; 3; 4; 12; 12; 12; 8; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7021_40284a04-2843-435d-a463-ca74bd99aa4b 52731-7021 HUMAN OTC DRUG Lower Back Complex Ammonium muriaticum, Apis mellifica, Berberis vulgaris, Causticum, Chelidonium majus, Colocynthis, Cuprum aceticum, Gnaphalium poly., Nux vomica, Phytolacca decandra, Rhus toxicodendron, Stannum metallicum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. AMMONIUM CHLORIDE; APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; CAUSTICUM; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC ACETATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; TIN 8; 4; 4; 6; 4; 4; 4; 6; 6; 6; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7022_cba35ca6-3cf3-4b51-918c-e1a789ba780a 52731-7022 HUMAN OTC DRUG Shoulder/Arm Complex Berberis vulgaris, Calcarea carbonica, Carboneum sulphuratum, Causticum, Cimicifuga racemosa, Cuprum aceticum, Ferrum metallicum, Kali phosphoricum, Ruta graveolens, Silicea, Spigelia anthelmia, Spiraea ulmaria LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. BERBERIS VULGARIS ROOT BARK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARBON DISULFIDE; CAUSTICUM; BLACK COHOSH; CUPRIC ACETATE; IRON; POTASSIUM PHOSPHATE, DIBASIC; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SPIGELIA ANTHELMIA; FILIPENDULA ULMARIA ROOT 4; 8; 6; 6; 6; 4; 8; 8; 4; 8; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7023_35945241-a319-4ff1-b703-0d2b3b59dc1e 52731-7023 HUMAN OTC DRUG Skin Rash Complex Apis mellifica, Arnica montana, Belladonna, Calendula officinalis, Chelidonium majus, Echinacea angustifolia, Hepar sulphuris calcareum, Ipecacuanha, Ledum palustre, Rhus toxicodendron, Staphisagria, Urtica urens LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; IPECAC; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; DELPHINIUM STAPHISAGRIA SEED; URTICA URENS 4; 4; 6; 3; 4; 3; 10; 4; 4; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7024_25142970-f557-430e-a952-6ec1616eb5d3 52731-7024 HUMAN OTC DRUG Sport Injury Complex Apis mellifica, Arnica montana, Bryonia, Colchicum autumnale, Colocynthis, Cuprum aceticum, Ledum paustre, Petroleum, Ruta graveolens, Silicea, Stannum metallicum, Zincum metallicum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. APIS MELLIFERA; ARNICA MONTANA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC ACETATE; LEDUM PALUSTRE TWIG; LIQUID PETROLEUM; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; TIN; ZINC 4; 3; 4; 4; 4; 4; 4; 6; 4; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7025_5ca4be61-0d88-4635-bf1f-c65587f33162 52731-7025 HUMAN OTC DRUG Burn Complex Aconitum napellus 12X, Apis mellifica 4X, Arnica montana 3X, Berberis vulgaris 4X, Calendula officinalis 3X, Cantharis 4X, Carbo vegetabilis 12X, Causticum 3X, Echinacea angustifolia 3X,Glonoinum 6X, LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; LYTTA VESICATORIA; ACTIVATED CHARCOAL; CAUSTICUM; ECHINACEA ANGUSTIFOLIA; NITROGLYCERIN; HYPERICUM PERFORATUM; URTICA URENS 12; 4; 3; 4; 3; 4; 12; 3; 3; 6; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7026_ca091774-e428-44a7-9e81-dc4b4de273ff 52731-7026 HUMAN OTC DRUG Air Pollution Complex Arnica montana 6X, Bovista 6X, Calcarea carbonica 8X,Carbo vegetabilis 8X, Cicuta virosa 6X, Euphorbium officinarum 6X,Hydrastis canadensis 4X, Petroleum 6X, Phosphorus 8X, Plumbum metallicum 8X, Sulf LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ARNICA MONTANA; GIANT PUFFBALL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; CICUTA VIROSA ROOT; EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; LIQUID PETROLEUM; PHOSPHORUS; LEAD; SULFUR 6; 6; 8; 8; 6; 6; 4; 6; 8; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7027_14038e6c-a314-4a50-947b-27e94a40186f 52731-7027 HUMAN OTC DRUG Bloating Complex Allium Cepa, Argentum nitricum, Carbo vegetabilis, China officinalis, Crocus sativus, Kali carbonicum, Magnesia phosphorica, Momordica balsamina LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ONION; SILVER NITRATE; ACTIVATED CHARCOAL; CINCHONA PUBESCENS BARK; SAFFRON; POTASSIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MOMORDICA BALSAMINA IMMATURE FRUIT 4; 8; 8; 4; 6; 6; 8; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7028_af718a41-07eb-4353-85f0-acb6c85597de 52731-7028 HUMAN OTC DRUG Circulation Complex Aesculus hippocastanum, Arnica montana, Baryta carbonica, Belladonna, Calcarea carbonica, Chelidonium majus, China officinalis, Glonoinum, Sepia, Strophanthus hispidus LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. HORSE CHESTNUT; ARNICA MONTANA; BARIUM CARBONATE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CHELIDONIUM MAJUS; CINCHONA PUBESCENS BARK; NITROGLYCERIN; SEPIA OFFICINALIS JUICE; STROPHANTHUS HISPIDUS SEED 3; 4; 8; 6; 8; 4; 4; 6; 10; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7029_057d8bae-8d35-46d4-ba26-59ce2373c7c9 52731-7029 HUMAN OTC DRUG Cold Sore Complex Bryonia, Calcarea sulfurica, Clematis erecta, Graphites, Lycopodium clavatum, Natrum carbonicum, Natrum muriaticum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. BRYONIA ALBA ROOT; CALCIUM SULFATE ANHYDROUS; CLEMATIS RECTA FLOWERING TOP; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM CHLORIDE 6; 8; 6; 12; 12; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7030_4488ff62-8f05-42a3-b175-5fb81db8a008 52731-7030 HUMAN OTC DRUG Colic Complex Belladonna, Chamomilla, Colocynthis, Dioscorea villosa, Lacticum acidum, Magnesia phosphorica, Momordica balsamina, Plumbum metallicum, Stannum metallicum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ATROPA BELLADONNA; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA ROOT; LACTIC ACID, DL-; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MOMORDICA BALSAMINA IMMATURE FRUIT; LEAD; TIN 6; 4; 6; 6; 4; 8; 4; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7031_b560a5ff-c533-43ab-9412-a3a2a014f0fd 52731-7031 HUMAN OTC DRUG Fever Complex Aconitum napellus, Arnica montana, Baptisia tinctoria, Berberis vulgaris, Cactus grandiflorus,Chelidonium majus, Echinacea angustifolia, Ferrum phosphoricum, Hepar sulfuris calcareum, Urtica urens LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; SELENICEREUS GRANDIFLORUS STEM; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; CALCIUM SULFIDE; URTICA URENS 6; 6; 4; 4; 6; 6; 2; 8; 8; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7032_e2c560dd-5bc4-490e-9db9-80e68ede846d 52731-7032 HUMAN OTC DRUG Infection Complex Apis mellifica, Argentum Nitricum., Arnica montana, Belladonna, Berberis vulgaris, Bryonia, Calcarea sulfurica, Echinacea angustifolia, Echinacea purpurea, Ferrum phosphoricum, Hepar sulphuris calcareum, Pulsatilla LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. APIS MELLIFERA; SILVER CATION; ARNICA MONTANA; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM CATION; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; FERRUM PHOSPHORICUM; CALCIUM CATION; PULSATILLA VULGARIS 4; 10; 4; 6; 4; 6; 8; 2; 2; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7033_e722c718-2334-463e-a24d-f8c9f70dcb88 52731-7033 HUMAN OTC DRUG Joint Complex Aconitum napellus, Bryonia, Colchicum autumnale, Colocynthis, Dulcamara, Echinacea angustifolia, Formica, Ledum Palustre, Rhus toxicodendron, Ruta graveolens, Silicea, Sticta pulmonaria LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; CITRULLUS COLOCYNTHIS FRUIT PULP; SOLANUM DULCAMARA STEM; ECHINACEA ANGUSTIFOLIA; FORMICA RUFA; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; LOBARIA PULMONARIA 6; 4; 6; 6; 6; 2; 4; 4; 10; 4; 8; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7035_91a6c4b2-cb83-4bea-8195-492f45a3366a 52731-7035 HUMAN OTC DRUG Lymphatic Complex Baryta carbonica, Berberis vulgaris, Calcarea carbonica, Chelidonium majus, Clematis erecta, Echinacea angustifolia, Galium aparine, Graphites, Juglans regia, Spongia tosta, Thuja occidentalis, Urtica urens LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CHELIDONIUM MAJUS; CLEMATIS RECTA FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; GRAPHITE; JUGLANS REGIA FRUIT RIND, IMMATURE; SPONGIA OFFICINALIS SKELETON, ROASTED; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 8; 4; 12; 6; 6; 2; 4; 12; 6; 12; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7036_1c17bc1d-0e1f-499b-a6f4-a754c2f2c60a 52731-7036 HUMAN OTC DRUG Male Complex Cantharis, Chimaphila umbellata, Echinacea angustifolia, Pareira brava, Pulsatilla, Sabal Serrulata, Secale cornutum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. LYTTA VESICATORIA; CHIMAPHILA UMBELLATA; ECHINACEA ANGUSTIFOLIA; CHONDRODENDRON TOMENTOSUM ROOT; PULSATILLA VULGARIS; SAW PALMETTO; CLAVICEPS PURPUREA SCLEROTIUM 4; 4; 4; 4; 6; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7037_6a31a84b-a86f-46a6-8e0c-fb2153bc9314 52731-7037 HUMAN OTC DRUG Menopause Complex Belladonna, Calcarea carbonica, China officinalis, Glonoinum, Lilium Tigrinum, Platinum metallicum, Pulsatilla, Sanguinaria canadensis, Stannum metallicum, Sulfur LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CINCHONA PUBESCENS BARK; NITROGLYCERIN; LILIUM LANCIFOLIUM FLOWERING TOP; PLATINUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; TIN; SULFUR 12; 12; 6; 8; 6; 10; 12; 6; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7038_121aa97d-d378-4e5e-b697-8dbb3e48d2d0 52731-7038 HUMAN OTC DRUG Menstrual Cramp Complex Aesculus hippocastanum, Belladonna, Berberis vulgaris, Cactus grandiflorus, Chamomilla, China officinalis, Cuprum aceticum, Hyoscyamus niger, Kali carbonicum, Magnesia phosphorica, Pulsatilla, Stannum metallicum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. HORSE CHESTNUT; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; SELENICEREUS GRANDIFLORUS STEM; MATRICARIA RECUTITA; CINCHONA PUBESCENS BARK; CUPRIC ACETATE; HYOSCYAMUS NIGER; POTASSIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS; TIN 4; 6; 4; 4; 4; 6; 4; 6; 6; 8; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [iU]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7040_45394af8-a830-47ab-a417-3560f1828258 52731-7040 HUMAN OTC DRUG Muscle Cramp Complex Anacardium orientale, Belladonna, Cactus grandiflorus, Calcarea carbonica, Carboneum sulphuratum, Cuprum aceticum, Magnesia phosphorica, Secale cornutum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. SEMECARPUS ANACARDIUM JUICE; ATROPA BELLADONNA; SELENICEREUS GRANDIFLORUS STEM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARBON DISULFIDE; CUPRIC ACETATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM 6; 6; 6; 12; 10; 4; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7041_4e917dd3-32f4-4ef0-a85d-0594fd8910ce 52731-7041 HUMAN OTC DRUG Nervousness Complex Argentum nitricum, Belladonna, Cantharis, Chamomilla, Glonoinum, Kali bromatum, Phosphorus, Sepia, Valeriana officinalis, Zincum metallicum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. SILVER NITRATE; ATROPA BELLADONNA; LYTTA VESICATORIA; MATRICARIA RECUTITA; NITROGLYCERIN; POTASSIUM BROMIDE; PHOSPHORUS; SEPIA OFFICINALIS JUICE; VALERIAN; ZINC 12; 12; 12; 6; 6; 6; 5; 6; 3; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 52731-7042_820d65ca-2a0c-48d6-9211-4705dfc784f8 52731-7042 HUMAN OTC DRUG Phobia Complex Aconitum napellus, Argentum nitricum, Arnica montana, Valeriana officinalis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; SILVER NITRATE; ARNICA MONTANA; VALERIAN 12; 12; 12; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 52731-7043_a352f130-dbdc-4db1-95ec-9914be14129d 52731-7043 HUMAN OTC DRUG Anxiety Complex Ambra grisea, Argentum nitricum, Aurum metallicum, Kali phosphoricum, Valeriana officianalis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. AMBERGRIS; SILVER NITRATE; GOLD; POTASSIUM PHOSPHATE, DIBASIC; VALERIAN 6; 12; 12; 6; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 52731-7044_a0e35a74-d2ee-45dd-9aa8-9c6e1032ff8e 52731-7044 HUMAN OTC DRUG Toothache Complex Aconitum napellus, Chamomilla, Hekla lava, Magnesia carbonica, Mezereum, Phytolacca decandra, Silicea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. ACONITUM NAPELLUS; MATRICARIA RECUTITA; HEKLA LAVA; MAGNESIUM CARBONATE; DAPHNE MEZEREUM BARK; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE 12; 6; 12; 12; 12; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7045_e8faecca-d82e-4017-9b7d-7faf36f41255 52731-7045 HUMAN OTC DRUG Varicose Vein Complex Aesculus hippocastanum, Arnica montana, Berberis vulgaris, Carbo vegetabilis, Echinacea angustifolia, Hamamelis virginiana, Hydrofluoricum acidum, Lycopodium clavatum, Secale cornutum, Sulfur LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. HORSE CHESTNUT; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; ACTIVATED CHARCOAL; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; CLAVICEPS PURPUREA SCLEROTIUM; SULFUR 4; 4; 4; 8; 2; 4; 8; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7047_15fc298f-0589-46be-82c5-f4659f6f494e 52731-7047 HUMAN OTC DRUG Vision Complex Aurum metallicum, Belladonna, Cactus grandiflorus, China officinalis, Conium maculatum, Curare, Gelsemium sempervirens, Phosphorus, Ruta graveolens, Veratrum album LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. GOLD; ATROPA BELLADONNA; SELENICEREUS GRANDIFLORUS STEM; CINCHONA PUBESCENS BARK; CONIUM MACULATUM FLOWERING TOP; TUBOCURARINE CHLORIDE; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; VERATRUM ALBUM ROOT 12; 12; 4; 8; 8; 12; 12; 10; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL E 20171231 52731-7048_eb2e59f5-78f8-4e11-b15c-3ccffba82b73 52731-7048 HUMAN OTC DRUG Leg Cramp Complex Calcarea carbonica, Colocynthis, Cuprum aceticum, Lacticum acidum, Rhus toxicodendron, Secale cornutum, Veratrum album LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC ACETATE; LACTIC ACID, DL-; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM; VERATRUM ALBUM ROOT 8; 4; 4; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7049_c5c67cd2-ef55-49e5-878b-466470134ae1 52731-7049 HUMAN OTC DRUG Relaxation Complex Anacardium, Calcerea carbonica, Hypericum, Magnesia phosphorica, Piper methysticum, Ruta graveolens, Silicea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. SEMECARPUS ANACARDIUM JUICE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ST. JOHN'S WORT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PIPER METHYSTICUM ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE 30; 8; 6; 8; 3; 4; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7050_26b8fa80-39aa-4204-990c-8d97d4598e96 52731-7050 HUMAN OTC DRUG Bladder Complex Apis mellifica, Belladonna, Berberis vulgaris, Cantharis, Echinacea ang, Equissetum avense, Hydrastis, Mercurius solubilis, Pulsatilla, Staphysagria LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. APIS MELLIFERA; ATROPA BELLADONNA; BERBERIS VULGARIS FRUIT; LYTTA VESICATORIA; ECHINACEA ANGUSTIFOLIA; EQUISETUM ARVENSE TOP; GOLDENSEAL; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED 4; 6; 4; 4; 2; 6; 4; 8; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7051_ad047388-eea1-4135-b577-7d7d9f9734c9 52731-7051 HUMAN OTC DRUG Colon Complex Anacardium, Hepar sulfuis calcareum, Magnesia muriatica, Nux vomica, Platinum met., Plumbum met., Sepia LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. SEMECARPUS ANACARDIUM JUICE; CALCIUM SULFIDE; MAGNESIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PLATINUM; LEAD; SEPIA OFFICINALIS JUICE 30; 12; 8; 12; 12; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7052_1117244c-0251-4300-8eea-9bbc31423cb5 52731-7052 HUMAN OTC DRUG Defense Complex Berberis vulgaris, Galium aparine, Hydrastis, Lappa major, Solidago, Thuja occidentalis, Trifolium pratense, Urtica urens LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. BERBERIS VULGARIS ROOT BARK; GALIUM APARINE; GOLDENSEAL; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIFOLIUM PRATENSE FLOWER; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 6; 6; 6; 4; 4; 30; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52731-7053_dd967d8b-97b1-4071-8abf-a85bf1e4b5ec 52731-7053 HUMAN OTC DRUG Liver Complex Carduus marianus, Chelidonium majus, Cynara scolymus, Kali carbonicum, Lycopodium, Phosphorus, Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Nova Homeopathic Therapeutics, Inc. SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CYNARA SCOLYMUS LEAF; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TARAXACUM PALUSTRE ROOT 4; 4; 4; 8; 6; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 52747-110_d475cf07-2493-428e-a553-9466d2a12bae 52747-110 HUMAN PRESCRIPTION DRUG Divista Chromium Picolinate CAPSULE ORAL 20100710 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation CHROMIUM PICOLINATE; BIOTIN; PYRIDOXINE; CYANOCOBALAMIN; FOLIC ACID; OMEGA-3-ACID ETHYL ESTERS 1000; 2; 25; 15; 1; 300 ug/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 52747-250_7f411135-9493-4d1f-b956-bf0057480363 52747-250 HUMAN PRESCRIPTION DRUG HYLAFEM BORICUM ACIDUM 2X Boricum Acidum SUPPOSITORY VAGINAL 20151231 UNAPPROVED HOMEOPATHIC US Pharmaceutical Corporation BORIC ACID 2 [hp_X]/1 E 20171231 52747-475_5d801cfc-fd7e-fbeb-e053-2a91aa0aa33c 52747-475 HUMAN OTC DRUG Norel AD acetaminophen, chlorpheniramine maleate, and phenylephrine HCl TABLET, MULTILAYER ORAL 20120427 OTC MONOGRAPH FINAL part341 US Pharmaceutical Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 4; 10 mg/1; mg/1; mg/1 N 20181231 52747-480_51fa1666-3a2d-401c-afc2-85641bd92258 52747-480 HUMAN OTC DRUG NorelCS CS Chlorpheniramine Maleate/Dextromethorphan Hydrobromide/Phenylephrine Hydrochloride LIQUID ORAL 20120801 OTC MONOGRAPH FINAL part341 US Pharmaceutical Corporation CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 12.5; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 52747-620_6d0aebcd-c00d-48ea-9690-5c466810d4a3 52747-620 HUMAN PRESCRIPTION DRUG Concept OB Vitamin Mineral Supplement CAPSULE ORAL 20090101 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation FERROUS FUMARATE; IRON; ASCORBIC ACID; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; CALCIUM PANTOTHENATE; PYRIDOXINE HYDROCHLORIDE; BIOTIN; CYANOCOBALAMIN; CUPRIC SULFATE; MAGNESIUM SULFATE; MANGANESE SULFATE; ZINC SULFATE 130; 92.4; 210; 1; 5; 5; 20; 7; 25; 300; 10; 800; 6.9; 1.3; 18.2 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 52747-621_de12d125-2cc8-4993-817c-8663b5b7e1f2 52747-621 HUMAN PRESCRIPTION DRUG Concept DHA Vitamin- Mineral Omega-3 Supplement CAPSULE, LIQUID FILLED ORAL 20090624 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation FERROUS FUMARATE; IRON; ASCORBIC ACID; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; CALCIUM PANTOTHENATE; PYRIDOXINE HYDROCHLORIDE; BIOTIN; CYANOCOBALAMIN; CUPRIC SULFATE; MAGNESIUM SULFATE; ZINC SULFATE; OMEGA-3-ACID ETHYL ESTERS 53.5; 38; 25; 1; 2; 3; 1.8; 5; 25; 300; 12.5; 2; 5; 10; 200 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 52747-711_61d8deac-80ef-45b0-b812-6c824bd1a869 52747-711 HUMAN PRESCRIPTION DRUG Integra F Ferrous Fumarate and Polysacchride Iron Complex and Folic Acid CAPSULE ORAL 20090427 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation FERROUS FUMARATE; FERROUS ASPARTO GLYCINATE; FOLIC ACID; ASCORBIC ACID; NIACIN 191.2; 135.9; 1; 40; 3 mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 52747-712_d8d20e53-d247-46a1-b572-8b541e453051 52747-712 HUMAN PRESCRIPTION DRUG Integra Plus Ferrous Fumarate and Polysacchride Iron Vitamin Mineral Complex Supplement CAPSULE ORAL 20090427 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation FERROUS FUMARATE; FERROUS ASPARTO GLYCINATE; FOLIC ACID; ASCORBIC ACID; NIACIN; THIAMINE MONONITRATE; RIBOFLAVIN; CALCIUM PANTOTHENATE; PYRIDOXINE HYDROCHLORIDE; BIOTIN 191.2; 135.9; 1; 210; 20; 5; 5; 7; 25; 300 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 52747-900_6f3280b9-49e3-4ff2-9c07-80bd1fded4e4 52747-900 HUMAN PRESCRIPTION DRUG Tandem Ferrous Fumarate and Polysacchride Iron Complex CAPSULE ORAL 20060217 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation FERROUS FUMARATE; FERROUS ASPARTO GLYCINATE 162; 115.2 mg/1; mg/1 E 20171231 52747-901_6f3280b9-49e3-4ff2-9c07-80bd1fded4e4 52747-901 HUMAN PRESCRIPTION DRUG Tandem - F Ferrous Fumarate and Polysacchride Iron Complex and Folic Acid CAPSULE ORAL 20060617 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation FERROUS ASPARTO GLYCINATE; FOLIC ACID; FERROUS FUMARATE 115.2; 1; 162 mg/1; mg/1; mg/1 E 20171231 52747-902_6f3280b9-49e3-4ff2-9c07-80bd1fded4e4 52747-902 HUMAN PRESCRIPTION DRUG Tandem Plus Ferrous Fumarate and Polysacchride Iron Vitamin Mineral Complex Supplement CAPSULE ORAL 20060617 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation FERROUS FUMARATE; FERROUS ASPARTO GLYCINATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; NIACINAMIDE; CALCIUM PANTOTHENATE; ZINC SULFATE; MAGNESIUM SULFATE; CUPRIC SULFATE; FOLIC ACID 162; 115.2; 200; 10; 6; 5; 15; 30; 10; 18.2; 1.3; .8; 1 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 52747-903_92dfaad9-48e9-4b3c-9e8e-18844a3fd6e5 52747-903 HUMAN PRESCRIPTION DRUG Tandem OB Vitamin Mineral Supplement CAPSULE ORAL 20060617 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation FERROUS FUMARATE; IRON; SODIUM ASCORBATE; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; CALCIUM PANTOTHENATE; MAGNESIUM SULFATE; CUPRIC SULFATE 162; 115.2; 200; 10; 6; 5; 15; 1; 30; 10; 1.3; .8 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 52747-904_44897973-0aca-45f0-a4cc-f414635d2fd6 52747-904 HUMAN PRESCRIPTION DRUG Tandem DHA Vitamin- Mineral Omega-3 Supplement CAPSULE ORAL 20070117 UNAPPROVED DRUG OTHER US Pharmaceutical Corporation FERROUS FUMARATE; IRON; ASCORBIC ACID; PYRIDOXINE HYDROCHLORIDE; OMEGA-3-ACID ETHYL ESTERS; FOLIC ACID 15; 15; 20; 25; 310.1; 1 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 52751-001_9ec995c2-2679-4a7c-9443-11d3aca4b3ea 52751-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20100801 UNAPPROVED MEDICAL GAS Rezk Medical Supply OXYGEN 99 L/100L E 20171231 52759-400_5915786c-39b1-d1d4-e053-2a91aa0aacbf 52759-400 HUMAN OTC DRUG Oosafe Disinfectant Benzalkonium Chloride LIQUID TOPICAL 20120430 OTC MONOGRAPH NOT FINAL part333A SparMed ApS BENZALKONIUM CHLORIDE 2.6 g/L N 20181231 52759-922_4d86055e-741c-4d06-e054-00144ff88e88 52759-922 HUMAN OTC DRUG Oosafe Disinfectant Benzalkonium Chloride LIQUID TOPICAL 20120430 OTC MONOGRAPH NOT FINAL part333A SparMED ApS BENZALKONIUM CHLORIDE 1.3 g/L N 20181231 52763-101_a4e276e5-348a-4605-b829-ab0d5c20d564 52763-101 HUMAN OTC DRUG LidoCream 10 Lidocaine CREAM TOPICAL 20150505 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 10 g/100g E 20171231 52763-401_aa1469b3-6e8a-418f-a110-755a24d8fe9a 52763-401 HUMAN OTC DRUG LidoCream 4 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 4 g/100g E 20171231 52763-401_baaf3802-2c1d-4e7f-865f-b4157320dcc6 52763-401 HUMAN OTC DRUG LidoCream 4 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 4 g/100g E 20171231 52763-501_0147c678-c21b-48f9-a03d-f6bfe7154bcb 52763-501 HUMAN OTC DRUG LidoCream 5 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g E 20171231 52763-501_f4d615da-1562-4a54-9680-7389e52c89fb 52763-501 HUMAN OTC DRUG LidoCream 5 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g E 20171231 52763-501_fa1db399-3bd1-456f-bcf5-9b97713ee5f1 52763-501 HUMAN OTC DRUG LidoCream 5 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g E 20171231 52763-502_bd39d172-d281-4343-b917-0d7c026f4639 52763-502 HUMAN OTC DRUG LidoCream 5 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g E 20171231 52763-504_b74ead94-3abd-4875-a8f9-7a88223474d4 52763-504 HUMAN OTC DRUG LidoCream 5 Lidocaine CREAM TOPICAL 20101201 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g E 20171231 52763-600_c611f727-311d-4629-92ea-c40f2d805de3 52763-600 HUMAN OTC DRUG Simply Numb Endure Lidocaine CREAM TOPICAL 20140708 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g E 20171231 52763-601_f5f1df1a-af40-45e8-b230-d3e1085a2917 52763-601 HUMAN OTC DRUG Simply Numb Endure Lidocaine CREAM TOPICAL 20140708 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g E 20171231 52763-602_3746ea26-1e0c-46a5-a8bc-07e29630208a 52763-602 HUMAN OTC DRUG Simply Numb Endure Lidocaine CREAM TOPICAL 20140708 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g E 20171231 52763-604_e7507fd7-8026-4327-a52b-8aa13b2e20a3 52763-604 HUMAN OTC DRUG Simply Numb Endure Lidocaine CREAM TOPICAL 20140708 OTC MONOGRAPH FINAL part346 Golden Touch LLC LIDOCAINE 5 g/100g E 20171231 52768-001_139fb76b-aef1-4aea-e054-00144ff8d46c 52768-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F-18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20101010 ANDA ANDA204546 Precision Nuclear LLC FLUDEOXYGLUCOSE F-18 500 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 52768-100_0aa84d7b-6d94-4449-bda7-43a8ab8c4711 52768-100 HUMAN PRESCRIPTION DRUG AMMONIA N-13 AMMONIA N-13 INJECTION, SOLUTION INTRAVENOUS 20101010 ANDA ANDA204547 Precision Nuclear LLC AMMONIA N-13 260 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 52768-125_e4731d71-a3da-476e-9b73-910eb04f252f 52768-125 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20110101 ANDA ANDA204542 Precision Nuclear LLC SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 52768-300_2f6d6994-701a-4025-92a1-597e914809aa 52768-300 HUMAN PRESCRIPTION DRUG Choline C 11 choline C 11 INJECTION INTRAVENOUS 20130607 UNAPPROVED DRUG OTHER Precision Nuclear LLC CHOLINE C-11 33.1 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 52773-235_eb32d905-7373-47b1-aa66-012cafc18911 52773-235 HUMAN OTC DRUG Lorac Foundation Fair SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52773-236_5f56551b-e033-4bb0-8a5b-d7c5f747484d 52773-236 HUMAN OTC DRUG Lorac Foundation Light SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52773-237_b67a9c24-f684-4e35-9bf7-3fdc6a95fd46 52773-237 HUMAN OTC DRUG Lorac Foundation Light Beige SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52773-238_241b5502-7ae9-402c-b41c-17329080867d 52773-238 HUMAN OTC DRUG Lorac Foundation Medium SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52773-239_ce6a3a9a-55ab-40b5-8e3a-519b9943619b 52773-239 HUMAN OTC DRUG Lorac Foundation Golden Light SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52773-240_1f3a08f4-8f1b-4861-9102-22542cc7a28e 52773-240 HUMAN OTC DRUG Lorac Foundation Medium Beige SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52773-241_5dbea8cf-ec60-4d24-80d8-6e7c640dcae9 52773-241 HUMAN OTC DRUG Lorac Foundation Medium Tan SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52773-242_6d1cfe2d-7d56-4602-a796-d9fdf0f1b08d 52773-242 HUMAN OTC DRUG Lorac Foundation Golden Tan SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52773-243_1ae5cd94-fb67-4f10-a391-ff4a86cd99de 52773-243 HUMAN OTC DRUG Lorac Foundation Tan SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52773-244_651b9e0e-e547-49a5-907d-7c65384a20ac 52773-244 HUMAN OTC DRUG Lorac Foundation Deep SPF20 Octinoxate, Octisalate, Avobenzone EMULSION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Lorac Cosmetics, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52793-700_83605e7c-39bf-9666-c6fd-23b5eeb14b5d 52793-700 HUMAN PRESCRIPTION DRUG Ahealon arnica montana, calendula officinalis flowering top, echinacea angustifolia, st. johns wort, silver, sulfur, allylthiourea and urtica urens SPRAY TOPICAL 20120409 UNAPPROVED HOMEOPATHIC PRINCETON BIOTECHNOLOGY CORPORATION ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; ST. JOHN'S WORT; SILVER; SULFUR; ALLYLTHIOUREA; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30 {kp_C}/60mL; {kp_C}/60mL; {kp_C}/60mL; {kp_C}/60mL; {kp_C}/60mL; {kp_C}/60mL; {kp_C}/60mL; {kp_C}/60mL N 20181231 52796-171_d7d84fa2-49c8-4bf3-b901-d3c381fbc948 52796-171 HUMAN PRESCRIPTION DRUG Floriva Plus VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE GLUCOSAMINE, CYANOCOBALAMIN, BIOTIN, PANTOTHENIC ACID, and SODIUM FLUORIDE SOLUTION/ DROPS ORAL 20160620 UNAPPROVED DRUG OTHER BonGeo Pharmaceuticals, Inc. VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE GLUCOSAMINE; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID; SODIUM FLUORIDE 1150; 32; 400; 5; .5; .6; 2; .4; 29.7; 2; 3; 1; .25 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC] N 20191231 52796-172_bcfa98da-f6a8-48f2-91a3-0d511a88ccf9 52796-172 HUMAN PRESCRIPTION DRUG Floriva CHOLECALCIFEROL and SODIUM FLUORIDE LIQUID ORAL 20141015 UNAPPROVED DRUG OTHER BonGeo Pharmaceuticals, Inc. CHOLECALCIFEROL; SODIUM FLUORIDE 400; .25 [iU]/mL; mg/mL Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20191231 52796-173_35f6ef1e-f62c-4263-85a0-b826a1d561ab 52796-173 HUMAN PRESCRIPTION DRUG Floriva VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20150910 UNAPPROVED DRUG OTHER BonGeo Pharmaceuticals, Inc. VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; ZINC GLUCONATE; CUPRIC OXIDE; SODIUM FLUORIDE 1000; 1000; 75; 600; 20; 1.3; 1.5; 15; 1.8; 162; 100; 6; 40; 5; 1; .25 [iU]/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20191231 52796-174_9e0a5c11-6f24-4316-a442-177bbe51706c 52796-174 HUMAN PRESCRIPTION DRUG Floriva VITAMIN A ACETATE, .BETA.-CAROTENE, Ascorbic acid, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20141015 UNAPPROVED DRUG OTHER BonGeo Pharmaceuticals, Inc. VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; ZINC GLUCONATE; CUPRIC OXIDE; SODIUM FLUORIDE 1000; 1000; 75; 600; 20; 1.3; 1.5; 15; 1.8; 162; 100; 6; 40; 5; 1; .5 [iU]/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20191231 52796-177_97281e21-0905-47ef-94ed-d365044b1745 52796-177 HUMAN PRESCRIPTION DRUG Floriva VITAMIN A ACETATE, .BETA.-CAROTENE, Ascorbic acid, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20141015 UNAPPROVED DRUG OTHER BonGeo Pharmaceuticals, Inc. VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE; LEVOMEFOLATE GLUCOSAMINE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; ZINC GLUCONATE; CUPRIC OXIDE; SODIUM FLUORIDE 1000; 1000; 75; 600; 20; 1.3; 1.5; 15; 1.8; 162; 100; 6; 40; 5; 1; 1 [iU]/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20191231 52810-102_c0193c3c-a061-4540-a114-130d4f66ab78 52810-102 HUMAN OTC DRUG ACNE FREE ECHINACEA ANGUSTIFOLIA, CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, MAHONIA AQUIFOLIUM FRUITING TOP SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY ECHINACEA ANGUSTIFOLIA; CALENDULA OFFICINALIS FLOWER; SAMBUCUS NIGRA FLOWER; MAHONIA AQUIFOLIUM FRUITING TOP 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-103_e4120124-4cc4-4edc-bafa-997a1f423d69 52810-103 HUMAN OTC DRUG EXTRA DRAWING ACNE RELIEF MAHONIA AQUIFOLIUM, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, SAMBUCUS NIGRA, THUJA OCCIDENTALIS SALVE TOPICAL 20160613 UNAPPROVED HOMEOPATHIC PUREMEDY MAHONIA AQUIFOLIUM FRUITING TOP; CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER; THUJA OCCIDENTALIS LEAF 1; 1; 1; 1; 1 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g E 20171231 52810-201_53e8a48b-22a6-4221-a7cb-085474067228 52810-201 HUMAN OTC DRUG BABY SKIN PINE NEEDLE OIL (PINUS SYLVESTRIS) SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS) 6; 3; 3; 2 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-202_a4df9453-d1b0-4c21-9899-478655130e6c 52810-202 HUMAN OTC DRUG FIRST AID SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS) SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS) 2; 2; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-203_e11f73c3-dbbb-42d4-9683-dad400bcd6df 52810-203 HUMAN OTC DRUG ORIGINAL HEALING PINE NEEDLE OIL (PINUS SYLVESTRIS) SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS); ECHINACEA ANGUSTIFOLIA 1; 2; 1; 2 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-204_6b82c28c-d685-4a17-90bf-8048a67d9fde 52810-204 HUMAN OTC DRUG INTENSIVE SKIN REPAIR SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINUS LAMBERTIANA RESIN ABIES BALSAMEA LEAF OIL SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; PINUS LAMBERTIANA RESIN; ABIES BALSAMEA LEAF OIL 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-205_fdcc4428-83bd-4a8b-affd-25e6c9fe667e 52810-205 HUMAN OTC DRUG VETERNIARY FIRST AID SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS) SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS) 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-206_31413d34-770f-4320-9ec3-e33e02873dcf 52810-206 HUMAN OTC DRUG SKIN TAG RELIEF CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, ECHINACEA ANGUSTIFOLIA, THUJA OCCIDENTALIS SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; SAMBUCUS NIGRA FLOWER; ECHINACEA ANGUSTIFOLIA; THUJA OCCIDENTALIS LEAF 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-212_cb1a283f-ff2e-4cdf-b4b4-a1e3d9cc131a 52810-212 HUMAN OTC DRUG FIRST AID SAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-213_798ba81d-1518-4ecf-ba58-45b209770b6b 52810-213 HUMAN OTC DRUG ORIGINAL HEALING SAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-214_a658516f-4785-4429-aaa5-5a83526162d7 52810-214 HUMAN OTC DRUG BABY ACNE CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, THUJA OCCIDENTALIS SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; SAMBUCUS NIGRA FLOWER; THUJA OCCIDENTALIS LEAF 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-217_f29107e4-0896-4075-96e2-298a5762e3bf 52810-217 HUMAN OTC DRUG BABY ECZEMA RELIEF CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; SAMBUCUS NIGRA FLOWER 1; 1 [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-218_cfbf67dc-eba9-43b3-937d-404239554277 52810-218 HUMAN OTC DRUG RASH RELIEF ARNICA MONTANA, CALENDULA OFFICINALIS, SAMBUCUS NIGRA SALVE TOPICAL 20150504 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; SAMBUCUS NIGRA FLOWER; ARNICA MONTANA 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-219_e676cad2-5f16-43ee-9a78-836d623554a9 52810-219 HUMAN OTC DRUG ALL NATURAL WOUND CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20160909 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-301_02dd4fbd-46d1-404c-97b7-76ff3b1a37a0 52810-301 HUMAN OTC DRUG COLD SORE FREE SAMBUCUS NIGRA FLOWER ECHINACEA ANGUSTIFOLIA CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS) THUJA OCCIDENTALIS ROOT SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS); THUJA OCCIDENTALIS ROOT 2; 1; 1; 1; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-401_382837c3-18c2-48f6-be3e-9253d6f4f8b2 52810-401 HUMAN OTC DRUG ECZEMA AND PSORIASIS FREE PINE NEEDLE OIL (PINUS SYLVESTRIS) SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER MAHONIA AQUIFOLIUM ROOT BARK ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS); MAHONIA AQUIFOLIUM ROOT BARK 6; 2; 2; 1; 3 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-402_8435efd9-76f6-4b28-9ccf-75c022517794 52810-402 HUMAN OTC DRUG SHINGLES RELIEF CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, ECHINACEA ANGUSTIFOLIA, THUJA OCCIDENTALIS, ARNICA MONTANA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; SAMBUCUS NIGRA FLOWER; ECHINACEA ANGUSTIFOLIA; THUJA OCCIDENTALIS LEAF; ARNICA MONTANA 1; 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-411_50c718b5-9aea-4cf5-918d-31a174540ca5 52810-411 HUMAN OTC DRUG ECZEMA AND PSORIASIS FREE SAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, ECHINACEA ANGUSTIFOLIA, BERBERIS VULGARIS WHOLE SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY ECHINACEA ANGUSTIFOLIA; SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; BERBERIS VULGARIS WHOLE 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-501_c5ae2154-876f-4954-a677-765ac83a154c 52810-501 HUMAN OTC DRUG FUNGUS FREE PINE NEEDLE OIL (PINUS SYLVESTRIS) SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER THUJA OCCIDENTALIS LEAFY TWIG SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS); THUJA OCCIDENTALIS LEAFY TWIG 2; 2; 1; 3 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-511_5516bc0d-7625-4412-be44-fea2b5351457 52810-511 HUMAN OTC DRUG FUNGUS FREE SAMBUCUS NIGRA FLOWER, CALENDULA OFFICINALIS FLOWER, THUJA OCCIDENTALIS LEAFY TWIG, ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA ANGUSTIFOLIA 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-602_3ffc96f4-7f30-455e-8c28-aa8f8ece553d 52810-602 HUMAN OTC DRUG ROSACEA FREE PINE NEEDLE OIL (PINUS SYLVESTRIS) SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER ABIES BALSAMEA LEAF OIL ECHINACEA ANGUSTIFOLIA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS); ABIES BALSAMEA LEAF OIL; ECHINACEA ANGUSTIFOLIA 2; 2; 1; 2; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-701_7ace3124-bb2c-42e3-98ff-92d9e0803cb0 52810-701 HUMAN OTC DRUG WART FREE SAMBUCUS NIGRA FLOWER ECHINACEA ANGUSTIFOLIA CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS) THUJA OCCIDENTALIS WHOLE SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; ECHINACEA ANGUSTIFOLIA; PINE NEEDLE OIL (PINUS SYLVESTRIS); THUJA OCCIDENTALIS WHOLE 1; 1; 2; 1; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-702_8f5e4048-5262-457b-a72e-d959271d1849 52810-702 HUMAN OTC DRUG POISON OAK AND IVY RELIEF CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, ECHINACEA ANGUSTIFOLIA, ARNICA MONTANA SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; SAMBUCUS NIGRA FLOWER; ECHINACEA ANGUSTIFOLIA; ARNICA MONTANA 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-703_2a4108a1-203a-4d3c-877a-59494c1ae555 52810-703 HUMAN OTC DRUG SORE MUSCLE AND JOINT PAIN RELIEF ARNICA MONTANA AND HYPERICUM PERFORATUM CREAM TOPICAL 20131017 UNAPPROVED HOMEOPATHIC PUREMEDY ARNICA MONTANA; HYPERICUM PERFORATUM 1; 1 [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-801_6af540c6-4628-456e-bfab-33377d3622ac 52810-801 HUMAN OTC DRUG PERSONAL LUBRICANT SAMBUCUS NIGRA FLOWER CALENDULA OFFICINALIS FLOWER PINE NEEDLE OIL (PINUS SYLVESTRIS) SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY SAMBUCUS NIGRA FLOWER; CALENDULA OFFICINALIS FLOWER; PINE NEEDLE OIL (PINUS SYLVESTRIS); BERBERIS VULGARIS FRUIT 2; 2; 2; 3 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52810-802_1e29c70a-d032-4ee6-9716-8c21779ab767 52810-802 HUMAN OTC DRUG HEMORRHOID RELIEF CALENDULA OFFICINALIS FLOWER, SAMBUCUS NIGRA FLOWER, ECHINACEA ANGUSTIFOLIA, THUJA OCCIDENTALIS SALVE TOPICAL 20121018 UNAPPROVED HOMEOPATHIC PUREMEDY CALENDULA OFFICINALIS FLOWER; SAMBUCUS NIGRA FLOWER; ECHINACEA ANGUSTIFOLIA; THUJA OCCIDENTALIS LEAF 1; 1; 1; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 52817-120_51d0713f-2e17-33a1-e054-00144ff88e88 52817-120 HUMAN PRESCRIPTION DRUG glyBURIDE glyBURIDE TABLET ORAL 20160601 ANDA ANDA203581 TruPharma, LLC GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 52817-121_51d0713f-2e17-33a1-e054-00144ff88e88 52817-121 HUMAN PRESCRIPTION DRUG glyBURIDE glyBURIDE TABLET ORAL 20160601 ANDA ANDA203581 TruPharma, LLC GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 52817-122_51d0713f-2e17-33a1-e054-00144ff88e88 52817-122 HUMAN PRESCRIPTION DRUG glyBURIDE glyBURIDE TABLET ORAL 20160601 ANDA ANDA203581 TruPharma, LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 52817-130_b060326c-0bba-480b-8a1f-f7310da6edc9 52817-130 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20160419 ANDA ANDA202036 Trupharma, LLC VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52817-131_b060326c-0bba-480b-8a1f-f7310da6edc9 52817-131 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20160419 ANDA ANDA202036 Trupharma, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52817-132_b060326c-0bba-480b-8a1f-f7310da6edc9 52817-132 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20160419 ANDA ANDA202036 Trupharma, LLC VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52817-133_b060326c-0bba-480b-8a1f-f7310da6edc9 52817-133 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20160419 ANDA ANDA202036 Trupharma, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52817-134_b060326c-0bba-480b-8a1f-f7310da6edc9 52817-134 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20160419 ANDA ANDA202036 Trupharma, LLC VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52817-140_c99bdd4e-f632-460b-b2e3-af37995cf220 52817-140 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride TABLET, FILM COATED ORAL 20160930 ANDA ANDA203854 Trupharma, LLC PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52817-141_c99bdd4e-f632-460b-b2e3-af37995cf220 52817-141 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride TABLET, FILM COATED ORAL 20160930 ANDA ANDA203854 Trupharma, LLC PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52817-142_c99bdd4e-f632-460b-b2e3-af37995cf220 52817-142 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride TABLET, FILM COATED ORAL 20160930 ANDA ANDA203854 Trupharma, LLC PAROXETINE HYDROCHLORIDE ANHYDROUS 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52817-143_c99bdd4e-f632-460b-b2e3-af37995cf220 52817-143 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride TABLET, FILM COATED ORAL 20160930 ANDA ANDA203854 Trupharma, LLC PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52817-160_4e1fda98-cc3a-4aa1-e054-00144ff88e88 52817-160 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, EXTENDED RELEASE ORAL 20170510 ANDA ANDA206260 TruPharma, LLC QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 52817-161_4e1fda98-cc3a-4aa1-e054-00144ff88e88 52817-161 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, EXTENDED RELEASE ORAL 20170510 ANDA ANDA206260 TruPharma, LLC QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 52817-162_4e1fda98-cc3a-4aa1-e054-00144ff88e88 52817-162 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, EXTENDED RELEASE ORAL 20170510 ANDA ANDA206260 TruPharma, LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 52817-163_4e1fda98-cc3a-4aa1-e054-00144ff88e88 52817-163 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, EXTENDED RELEASE ORAL 20170510 ANDA ANDA206260 TruPharma, LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 52817-164_4e1fda98-cc3a-4aa1-e054-00144ff88e88 52817-164 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, EXTENDED RELEASE ORAL 20170510 ANDA ANDA206260 TruPharma, LLC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 52817-180_bf812c99-7cb8-444a-bfdb-25e89bc3a80a 52817-180 HUMAN PRESCRIPTION DRUG Clonidine hydrochloride Clonidine hydrochloride TABLET ORAL 20170601 ANDA ANDA070925 TruPharma, LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 52817-181_bf812c99-7cb8-444a-bfdb-25e89bc3a80a 52817-181 HUMAN PRESCRIPTION DRUG Clonidine hydrochloride Clonidine hydrochloride TABLET ORAL 20170601 ANDA ANDA070924 TruPharma, LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 52817-182_bf812c99-7cb8-444a-bfdb-25e89bc3a80a 52817-182 HUMAN PRESCRIPTION DRUG Clonidine hydrochloride Clonidine hydrochloride TABLET ORAL 20170601 ANDA ANDA070923 TruPharma, LLC CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 52817-190_593ba754-7f79-4d5a-bc0e-2eb248ea2c0e 52817-190 HUMAN PRESCRIPTION DRUG Cyclobenzaprine hydrochloride Cyclobenzaprine hydrochloride TABLET ORAL 20170601 ANDA ANDA073541 TruPharma, LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 52817-191_593ba754-7f79-4d5a-bc0e-2eb248ea2c0e 52817-191 HUMAN PRESCRIPTION DRUG Cyclobenzaprine hydrochloride Cyclobenzaprine hydrochloride TABLET ORAL 20170601 ANDA ANDA073541 TruPharma, LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 52817-210_9c0b47c0-ecd2-450f-9dcb-c262db92866e 52817-210 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20170117 ANDA ANDA206553 Trupharma, Llc CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 52817-240_ac980d34-2620-423c-ba79-e07a34f04cc3 52817-240 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20170605 ANDA ANDA202887 TruPharma, LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 52817-241_ac980d34-2620-423c-ba79-e07a34f04cc3 52817-241 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20170605 ANDA ANDA202887 TruPharma, LLC LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 52817-242_ac980d34-2620-423c-ba79-e07a34f04cc3 52817-242 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20170605 ANDA ANDA202887 TruPharma, LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 52817-243_ac980d34-2620-423c-ba79-e07a34f04cc3 52817-243 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20170605 ANDA ANDA202887 TruPharma, LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 52841-010_71aa7a87-ca1f-4b24-9813-921176f5a9a3 52841-010 HUMAN OTC DRUG PHYLLIS GOLDEN HAIR OATMEAL SHAMPOO CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 UNOCOS CO., LTD. OATMEAL .004 mL/400mL E 20171231 52841-020_7c05a4e5-c3c0-4c3b-a38c-ab1c19fde097 52841-020 HUMAN OTC DRUG PHYLLIS GOLDEN HAIR ESSENCE OATMEAL SOLUTION CUTANEOUS 20100401 OTC MONOGRAPH FINAL part347 UNOCOS CO., LTD. OATMEAL .0008 mL/80mL E 20171231 52849-100_bf78c990-e6cf-4601-af71-97b85aba22ff 52849-100 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19520101 UNAPPROVED MEDICAL GAS Capweld Inc OXYGEN 99 L/100L E 20171231 52849-200_d9f4b162-4a2b-46ad-9024-8a9a3ebafd8c 52849-200 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19520101 UNAPPROVED MEDICAL GAS Capweld Inc NITROGEN 99 L/100L E 20171231 52849-500_b961abb3-5d3a-4aee-a871-d4fb2a901101 52849-500 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19520101 UNAPPROVED MEDICAL GAS Capweld Inc NITROUS OXIDE 99 L/100L E 20171231 52854-015_d5b121af-1571-45ec-bc08-3d925ecc3265 52854-015 HUMAN OTC DRUG Reef Safe SPF 15 octinoxate,octisalate, and oxybenzone LOTION TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 52854-016_66f87097-918f-4ef3-a3d2-0d0c78319816 52854-016 HUMAN OTC DRUG Reef Safe SPF 15 homosalate, octinoxate, oxybenzone and octisalate SPRAY TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE; OCTISALATE 10; 4; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-030_9dfc358e-715a-4a2b-ba21-890fdff1d6ad 52854-030 HUMAN OTC DRUG Reef Safe SPF 30 octinoxate,octisalate, and oxybenzone LOTION TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 4 g/100mL; g/100mL; g/100mL N 20181231 52854-031_55ac1f98-23ee-4d9b-b4a7-5d42f900bd8c 52854-031 HUMAN OTC DRUG Reef Safe SPF 30 homosalate, octocrylene, octinoxate, oxybenzone and octisalate SPRAY TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE; OCTISALATE 10; 6; 6; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-032_6eb069b9-4250-4424-be52-e041f0fb0707 52854-032 HUMAN OTC DRUG Reef Safe SPF 30 homosalate, octinoxate, oxybenzone and octisalate SPRAY TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE; OCTISALATE 10; 6; 6; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-036_3348b2be-857a-4f7c-bc90-764fe6e92fbc 52854-036 HUMAN OTC DRUG Reef Safe SPF 36 octinoxate, oxybenzone, octisalate, and homosalate LOTION TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTINOXATE; OXYBENZONE; OCTISALATE; HOMOSALATE 7.5; 6; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-045_1c492a85-2570-4316-839f-99a73041f003 52854-045 HUMAN OTC DRUG Reef Safe SPF 45 octocrylene, octinoxate, oxybenzone, homosalate and octisalate LOTION TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTINOXATE; OXYBENZONE; HOMOSALATE; OCTISALATE 8; 7.5; 6; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-046_880c7abd-d9f7-46bf-9fcf-87d06c71897c 52854-046 HUMAN OTC DRUG Reef Safe SPF 45 homosalate, octocrylene, octinoxate, oxybenzone and octisalate SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OXYBENZONE; OCTISALATE 10; 10; 7.5; 6; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-103_45b2b1b0-4258-4867-8f53-8a0977424b10 52854-103 HUMAN OTC DRUG Reef Safe SPF 30 Oxybenzone Free octocrylene, octisalate, and avobenzone SPRAY TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE 5; 3; 2.5 g/100mL; g/100mL; g/100mL N 20181231 52854-130_7837e44d-9e98-4fe0-8dca-9bb264e5ae29 52854-130 HUMAN OTC DRUG Reef Safe SPF 30 Oxybenzone Free octocrylene, octisalate, and avobenzone LOTION TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE 5; 3; 2.5 g/100mL; g/100mL; g/100mL N 20181231 52854-150_572a1bec-4d76-4f9a-a6a3-c03d06a718ae 52854-150 HUMAN OTC DRUG Reef Safe SPF 50 Oxybenzone Free octocrylene, octisalate, and avobenzone LOTION TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE 10; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52854-200_548fb565-ca36-469a-bea5-c4759c471295 52854-200 HUMAN OTC DRUG Reef Safe SPF 20 octocrylene, octisalate, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE 3; 2; 1 g/100mL; g/100mL; g/100mL N 20181231 52854-220_b3fe6ad7-666f-4277-b355-e9670894cc77 52854-220 HUMAN OTC DRUG Native Tan SPF 20 octocrylene, octisalate, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE 3; 2; 1 g/100mL; g/100mL; g/100mL N 20181231 52854-230_a67aa832-05b9-4ff4-a86a-4f504130e57b 52854-230 HUMAN OTC DRUG Native Tan SPF 30 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE 3; 2.5; 2.5; 1.25 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-240_b6932045-cc97-4c41-955a-3abc41f8b75b 52854-240 HUMAN OTC DRUG Native Tan SPF 40 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE 3.5; 3; 3; 1.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-250_371db9e4-f6e0-4116-ada1-20233498dab2 52854-250 HUMAN OTC DRUG Native Tan SPF 50 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE 5; 5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-255_c07d06cb-2297-4cfa-81a1-49d467445c2e 52854-255 HUMAN OTC DRUG Native Tan SPF 50 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE 5; 5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-300_bab95c4a-b207-4367-99ae-1934f81553b0 52854-300 HUMAN OTC DRUG Reef Safe SPF 30 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE 3; 2.5; 2.5; 1.25 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-400_6ff9e7dd-afe2-40b5-9b41-ec363b621142 52854-400 HUMAN OTC DRUG Reef Safe SPF 40 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE 3.5; 3; 3; 1.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-500_5b940586-1958-412a-951f-d6391bb74d52 52854-500 HUMAN OTC DRUG Reef Safe SPF 50 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE 5; 5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-513_45a65ffc-95e6-4361-b2ad-2c1eb046e729 52854-513 HUMAN OTC DRUG Reef Kids SPF 30 Oxybenzone Free octocrylene, octisalate, and avobenzone LOTION TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE 5; 3; 2.5 g/100mL; g/100mL; g/100mL N 20181231 52854-515_b0ad4400-e9c4-4c42-802e-c14119791904 52854-515 HUMAN OTC DRUG Reef Babies SPF 50 Oxybenzone Free octocrylene, octisalate, and avobenzone LOTION TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE 10; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52854-518_341059bb-0d06-4042-a351-cecf7bda3029 52854-518 HUMAN OTC DRUG Reef Safe SPF 50 Oxybenzone Free octocrylene, octisalate, and avobenzone SPRAY TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE 10; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52854-530_ef5877b0-e881-4e12-8c2c-dffd06c6e994 52854-530 HUMAN OTC DRUG Reef Kids SPF 30 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE 3; 2.5; 2.5; 1.25 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-531_43d91b72-bf11-4f04-b276-59bb53e415da 52854-531 HUMAN OTC DRUG Reef Kids SPF 30 homosalate, octinoxate, oxybenzone and octisalate SPRAY TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE; OCTISALATE 10; 6; 6; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-538_953906f8-0388-4a91-9d3f-b300b1b8f1e8 52854-538 HUMAN OTC DRUG Reef Kids SPF 30 Oxybenzone Free octocrylene, octisalate, and avobenzone SPRAY TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE 5; 3; 2.5 g/100mL; g/100mL; g/100mL N 20181231 52854-540_840ebf64-c006-4623-bf2d-5aff0c7aa6be 52854-540 HUMAN OTC DRUG Reef Kids SPF 40 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE 3.5; 3; 3; 1.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-550_6ff59f79-4c09-463c-801f-12fdd77938dc 52854-550 HUMAN OTC DRUG Reef Babies SPF 50 octocrylene, octisalate, oxybenzone, and avobenzone LOTION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; OXYBENZONE; AVOBENZONE 5; 5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 52854-558_2f082f06-0a2a-4aea-902e-3ccb7ba5f5cd 52854-558 HUMAN OTC DRUG Reef Babies SPF 50 Oxybenzone Free octocrylene, octisalate, and avobenzone SPRAY TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE 10; 5; 3 g/100mL; g/100mL; g/100mL N 20181231 52854-796_85cdd13c-0e4b-4906-a3b5-1eb8e40745ff 52854-796 HUMAN OTC DRUG Reef Safe SPF 30 octocrylene, octisalate, avobenzone LIPSTICK TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE 5; 3; 2.5 g/100g; g/100g; g/100g N 20181231 52854-930_9d72621b-20dd-4a8c-a04a-dd07766cf2f5 52854-930 HUMAN OTC DRUG Land Shark SPF 30 zinc oxide and titanium dioxide LOTION TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. ZINC OXIDE; TITANIUM DIOXIDE 7.5; 3.2 g/100mL; g/100mL N 20181231 52854-931_7357aad7-d716-42c1-9392-dd85f12e1677 52854-931 HUMAN OTC DRUG Land Shark SPF 30 Sunkissed zinc oxide and titanium dioxide LOTION TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part352 Tropical Seas, Inc. ZINC OXIDE; TITANIUM DIOXIDE 7.5; 3.2 g/100mL; g/100mL N 20181231 52856-501_13159821-b057-48f9-95a7-6e62c5045f39 52856-501 HUMAN PRESCRIPTION DRUG EMFLAZA deflazacort TABLET ORAL 20170209 NDA NDA208684 PTC Therapeutics, Inc. DEFLAZACORT 6 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 52856-502_13159821-b057-48f9-95a7-6e62c5045f39 52856-502 HUMAN PRESCRIPTION DRUG EMFLAZA deflazacort TABLET ORAL 20170209 NDA NDA208684 PTC Therapeutics, Inc. DEFLAZACORT 18 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 52856-503_13159821-b057-48f9-95a7-6e62c5045f39 52856-503 HUMAN PRESCRIPTION DRUG EMFLAZA deflazacort TABLET ORAL 20170209 NDA NDA208684 PTC Therapeutics, Inc. DEFLAZACORT 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 52856-504_13159821-b057-48f9-95a7-6e62c5045f39 52856-504 HUMAN PRESCRIPTION DRUG EMFLAZA deflazacort TABLET ORAL 20170209 NDA NDA208684 PTC Therapeutics, Inc. DEFLAZACORT 36 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 52856-505_13159821-b057-48f9-95a7-6e62c5045f39 52856-505 HUMAN PRESCRIPTION DRUG EMFLAZA deflazacort SUSPENSION ORAL 20170209 NDA NDA208685 PTC Therapeutics, Inc. DEFLAZACORT 22.75 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 52862-001_c224c94a-a633-4bb1-ada1-81a05617adde 52862-001 HUMAN OTC DRUG Petroleum WHITE PETROLEUM JELLY TOPICAL 20101020 OTC MONOGRAPH FINAL part347 International Wholesale Inc. PETROLATUM 100 g/100g E 20171231 52862-002_ec708a9d-23b9-44ab-b68f-5be183897c1d 52862-002 HUMAN OTC DRUG Petroleum Jelly Aloe Vera Scent WHITE PETROLEUM JELLY TOPICAL 20101021 OTC MONOGRAPH FINAL part347 International Wholesale Inc. PETROLATUM 99.9 g/100g E 20171231 52862-003_cceca6d2-02e8-4e5d-b1fc-aa57441978c0 52862-003 HUMAN OTC DRUG Petroleum Jelly Fresh Scent WHITE PETROLEUM JELLY TOPICAL 20101021 OTC MONOGRAPH FINAL part347 International Wholesale Inc. PETROLATUM 99.9 g/100g E 20171231 52862-004_f88fefdd-77e7-419f-b7ac-6254ab0e364c 52862-004 HUMAN OTC DRUG Petroleum Jelly Cocoa Butter Scent WHITE PETROLEUM JELLY TOPICAL 20101021 OTC MONOGRAPH FINAL part347 International Wholesale Inc. PETROLATUM 99.9 g/100g E 20171231 52862-005_8e92bc2b-61df-4a51-9ed2-83fd838fb28a 52862-005 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part333A Home Smart Products ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 52862-006_795f5942-d8e3-4108-b143-f263142742c7 52862-006 HUMAN OTC DRUG Isopropyl Rubbing Alcohol With Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part333A Home Smart Products ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 52862-007_a66cce04-9926-48b4-9ff5-5af28b3cc754 52862-007 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20120708 OTC MONOGRAPH NOT FINAL part333A Home Smart Products HYDROGEN PEROXIDE 3 mL/100mL N 20181231 52862-008_249575b6-5b73-46f5-a9a5-a981345a2feb 52862-008 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120722 OTC MONOGRAPH FINAL part333A Home Smart Products ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 52862-009_f4259d56-3049-4ee8-a6ca-c97aceee5c16 52862-009 HUMAN OTC DRUG Isopropyl Rubbing Alcohol With Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20120722 OTC MONOGRAPH FINAL part333A Home Smart Products ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 52862-010_aa30f062-3187-456e-bb83-fe75d0d4f969 52862-010 HUMAN OTC DRUG Health Smart Baby TALC POWDER TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part347 Home Smart Products TALC 1 g/g N 20181231 52862-011_a8ec41f8-3182-4bb3-bc1a-b50818a3a26e 52862-011 HUMAN OTC DRUG Health Smart Lavender Baby Petroleum White Petroleum JELLY TOPICAL 20130728 OTC MONOGRAPH FINAL part347 Home Smart Products PETROLATUM 99.9 g/100g N 20181231 52862-012_1f20e3e7-3270-4dee-a979-bf7b55a78779 52862-012 HUMAN OTC DRUG Health Smart Aloe Vera Petroleum White Petroleum JELLY TOPICAL 20130728 OTC MONOGRAPH FINAL part347 Home Smart Products PETROLATUM 99.9 g/100g N 20181231 52862-013_92331876-9f76-4765-8920-9ca2998502e5 52862-013 HUMAN OTC DRUG Health Smart Original Petroleum White Petroleum JELLY TOPICAL 20130728 OTC MONOGRAPH FINAL part347 Home Smart Products PETROLATUM 100 g/100g N 20181231 52862-014_8e45063b-d099-40f2-be28-1df7175ddde8 52862-014 HUMAN OTC DRUG Health Smart Cocoa Butter Petroleum White Petroleum JELLY TOPICAL 20130728 OTC MONOGRAPH FINAL part347 Home Smart Products PETROLATUM 99.9 g/100g N 20181231 52862-015_8a81d8ac-d5cf-40b1-a5bc-101b4d6a8638 52862-015 HUMAN OTC DRUG Health Smart Baby Petroleum White Petroleum JELLY TOPICAL 20130728 OTC MONOGRAPH FINAL part347 Home Smart Products PETROLATUM 99.9 g/100g N 20181231 52862-016_1d339218-5f57-2f8a-e054-00144ff88e88 52862-016 HUMAN OTC DRUG Health Smart Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 Home Smart Products CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.7; 1; 1 g/100g; g/100g; g/100g N 20181231 52862-017_54a6a677-7241-49f9-b5a7-999a3697b9e5 52862-017 HUMAN OTC DRUG Health Smart Blue Ice Topical Analgesic Menthol and Camphor GEL TOPICAL 20131002 OTC MONOGRAPH NOT FINAL part348 Home Smart Products MENTHOL; CAMPHOR (SYNTHETIC) 1; .5 g/100g; g/100g N 20181231 52862-018_1f02a972-550e-408e-85ea-0f84fc7c416e 52862-018 HUMAN OTC DRUG Health Smart Creamy Petroleum Petroleum JELLY TOPICAL 20140110 OTC MONOGRAPH FINAL part347 International Wholesale Inc dba Home Smart Products PETROLATUM 30 g/100g N 20181231 52862-019_53ecf499-f0e3-4870-9afd-5c4ece2ed428 52862-019 HUMAN OTC DRUG Health Smart Creamy Cocoa Butter Petroleum Petroleum JELLY TOPICAL 20140110 OTC MONOGRAPH FINAL part347 International Wholesale Inc dba Home Smart Products PETROLATUM 30 g/100g N 20181231 52862-020_ff69a3d2-ffad-4153-be70-eb07f59b7272 52862-020 HUMAN OTC DRUG Health Smart Medicated Body Menthol and Zinc Oxide POWDER TOPICAL 20140227 OTC MONOGRAPH NOT FINAL part348 International Wholesale Inc dba Home Smart Products MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g N 20181231 52862-021_30492149-ec96-4b96-9691-6e353fe10fde 52862-021 HUMAN OTC DRUG Health Smart Medicated Foot Menthol POWDER TOPICAL 20140227 OTC MONOGRAPH NOT FINAL part348 International Wholesale Inc dba Home Smart Products MENTHOL 1 g/100g N 20181231 52862-100_6ad7c986-f1c6-4c40-b21f-9c434720472c 52862-100 HUMAN OTC DRUG Health Smart Antibacterial Wet Wipes BENZETHONIUM CHLORIDE SWAB TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333A International Wholesale, Inc. BENZETHONIUM CHLORIDE .3 g/1001 E 20171231 52862-120_46c96dae-d1bd-4f23-b629-17f8837e9851 52862-120 HUMAN OTC DRUG Antibacterial Golden Burst Triclocarban SOAP TOPICAL 20150715 OTC MONOGRAPH NOT FINAL part333A International Wholesale, Inc. TRICLOCARBAN .3 g/100g E 20171231 52862-130_48558d39-bbb1-4a7c-a3a7-b3ae5a96760e 52862-130 HUMAN OTC DRUG Antibacterial Ocean Fresh Triclocarban SOAP TOPICAL 20150715 OTC MONOGRAPH NOT FINAL part333A International Wholesale, Inc. TRICLOCARBAN .3 g/100g E 20171231 52862-200_c74ab8c0-23e2-457e-a5aa-a2d4dcc7e20e 52862-200 HUMAN OTC DRUG Health Smart Natural Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL 20130801 OTC MONOGRAPH NOT FINAL part334 International Wholesale, Inc. MAGNESIUM SULFATE 1 g/g E 20171231 52862-201_42e0ae69-2760-4e6e-b8b8-2da52c319e40 52862-201 HUMAN OTC DRUG Health Smart Natural Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL 20130801 OTC MONOGRAPH NOT FINAL part334 International Wholesale, Inc. MAGNESIUM SULFATE 1 g/g E 20171231 52862-301_b9732780-c182-4e2c-bfde-e152e0044741 52862-301 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e cucumber melon ALCOHOL SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 65 mL/100mL N 20181231 52862-302_172d18de-2122-42fc-9c3e-6909510b438e 52862-302 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e sweet pea ALCOHOL SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 65 mL/100mL N 20181231 52862-303_43608b20-10e0-433c-8c45-30d9ed1ad2ad 52862-303 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e lavender ALCOHOL SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 65 mL/100mL N 20181231 52862-304_a9706aea-03c7-47c3-94b0-411f59668830 52862-304 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e peach ALCOHOL SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 65 mL/100mL N 20181231 52862-306_1633e875-5413-4f6e-a66f-d73ccb431bea 52862-306 HUMAN OTC DRUG Health Smart Antibacterial original TRICLOSAN SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. TRICLOSAN .15 mg/100mL N 20181231 52862-307_98266fdd-aa9a-46c7-b3d2-16721a050faa 52862-307 HUMAN OTC DRUG Health Smart Antibacterial cucumber melon TRICLOSAN SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. TRICLOSAN .15 mg/100mL N 20181231 52862-308_5f5b8ba9-f593-4ab3-9ef3-3ad2cbab910e 52862-308 HUMAN OTC DRUG Health Smart Antibacterial sweet pea orchid TRICLOSAN SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. TRICLOSAN .15 mg/100mL N 20181231 52862-309_9c7b268b-018b-4a11-843b-aa43884aee3b 52862-309 HUMAN OTC DRUG Health Smart Antibacterial lavender chamomile TRICLOSAN SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. TRICLOSAN .15 mg/100mL N 20181231 52862-310_d684cc32-257c-4b04-b66c-43e3c2fe93a9 52862-310 HUMAN OTC DRUG Health Smart Antibacterial Spring Rain TRICLOSAN SOLUTION TOPICAL 20131224 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. TRICLOSAN .15 mg/100mL N 20181231 52862-313_0dea23f8-c7bc-4cb6-be93-2956036033e2 52862-313 HUMAN OTC DRUG ANTIBACTERIAL BANDAGE benzalkonium chloride SWAB TOPICAL 20140923 OTC MONOGRAPH NOT FINAL part333A International Wholesale, Inc. BENZALKONIUM CHLORIDE 1 g/100g E 20171231 52862-314_f5e3ded5-f134-4f2c-b725-1b0adae744aa 52862-314 HUMAN OTC DRUG Total Comfort Fresh Blast aluminum chlorhydrate STICK TOPICAL 20140928 OTC MONOGRAPH FINAL part350 International Wholesale, Inc. ALUMINUM CHLOROHYDRATE 11.4 g/57g E 20171231 52862-315_8722b55b-21bd-46fb-85c5-f14e97de4fef 52862-315 HUMAN OTC DRUG Total Comfort Cool Blast aluminum chlorhydrate STICK TOPICAL 20140928 OTC MONOGRAPH FINAL part350 International Wholesale, Inc. ALUMINUM CHLOROHYDRATE 11.4 g/57g E 20171231 52862-401_084413d5-d20c-12d8-e054-00144ff88e88 52862-401 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e cucumber melon ALCOHOL SOLUTION TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 62 mL/100mL N 20181231 52862-402_084413d5-d21a-12d8-e054-00144ff88e88 52862-402 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e sweet pea ALCOHOL SOLUTION TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 62 mL/100mL N 20181231 52862-403_084413d5-d228-12d8-e054-00144ff88e88 52862-403 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e lavender ALCOHOL SOLUTION TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 62 mL/100mL N 20181231 52862-404_084413d5-d236-12d8-e054-00144ff88e88 52862-404 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e peach ALCOHOL SOLUTION TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 62 mL/100mL N 20181231 52862-405_084413d5-d244-12d8-e054-00144ff88e88 52862-405 HUMAN OTC DRUG Health Smart Instant Hand Sanitizer with aloe vera and vitamin e ALCOHOL SOLUTION TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E International Wholesale, Inc. ALCOHOL 62 mL/100mL N 20181231 52862-412_da30dd47-f183-4f3c-9f01-ba57d2006b5c 52862-412 HUMAN OTC DRUG 3 HAND SANITIZERS ALCOHOL KIT TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333A International Wholesale, Inc. N 20181231 52862-500_602b4f63-153a-3f33-e053-2a91aa0aeb73 52862-500 HUMAN OTC DRUG FreshMax Fluoride Regular Flavor SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20170227 OTC MONOGRAPH FINAL part355 International Wholesale Inc SODIUM MONOFLUOROPHOSPHATE 76 mg/g N 20181231 52862-501_602b184f-d4a0-7a31-e053-2a91aa0a8f23 52862-501 HUMAN OTC DRUG FreshMax Fluoride Minty Flavor SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20170227 OTC MONOGRAPH FINAL part355 International Wholesale Inc SODIUM MONOFLUOROPHOSPHATE 76 mg/g N 20181231 52862-502_602b21f6-1845-6334-e053-2991aa0afe7b 52862-502 HUMAN OTC DRUG FreshMax Fluoride Kids SODIUM FLUORIDE PASTE DENTAL 20170227 OTC MONOGRAPH FINAL part355 International Wholesale Inc SODIUM FLUORIDE 22 mg/g N 20181231 52891-100_9960d2bb-15e8-44e1-b3d0-15904fed11d3 52891-100 HUMAN OTC DRUG Dr. Oberon Moms Care Cream dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 Oberon Cosmetic Co., Ltd. DIMETHICONE 1 g/100g E 20171231 52891-101_45a35ea6-9af4-4375-b0fe-b36ed00a3a74 52891-101 HUMAN OTC DRUG Dr. OBERON MOMS CARE OIL dimethicone OIL TOPICAL 20140601 OTC MONOGRAPH FINAL part347 Oberon Cosmetic Co., Ltd. DIMETHICONE 1.5 1/150mL E 20171231 52891-102_86aafc39-2b4a-4e6e-85ac-50c08dc248b7 52891-102 HUMAN OTC DRUG Dr. OBERON MOMS CARE BODY OIL dimethicone OIL TOPICAL 20140612 OTC MONOGRAPH FINAL part347 Oberon Cosmetic Co., Ltd. DIMETHICONE 26 1/100mL E 20171231 52891-103_4fc9641a-9d0a-42fb-91de-eb735eb02127 52891-103 HUMAN OTC DRUG DR. OBERON NATURAL BABY allantoin LOTION TOPICAL 20140621 OTC MONOGRAPH FINAL part347 Oberon Cosmetic Co., Ltd. ALLANTOIN .5 1/50mL E 20171231 52891-104_ed5b7c1e-1d1f-4633-870c-c87cf3f53c33 52891-104 HUMAN OTC DRUG Dr. Oberon Diaper Rash Baby Cream zinc oxide, dimethicone CREAM TOPICAL 20140626 OTC MONOGRAPH FINAL part347 Oberon Cosmetic Co., Ltd. ZINC OXIDE; DIMETHICONE .75; .15 g/15g; g/15g E 20171231 52891-105_391b65e5-1212-4168-ab62-3a6c2be2b1f1 52891-105 HUMAN OTC DRUG Dr. Oberon Original Snail Cream dimethicone CREAM TOPICAL 20140627 OTC MONOGRAPH FINAL part347 Oberon Cosmetic Co., Ltd. DIMETHICONE 11.5 g/50g E 20171231 52893-001_01e0d895-cc73-46b3-a9cd-14550957c5ca 52893-001 HUMAN OTC DRUG Pure Snow whitening Sodium Fluoride GEL, DENTIFRICE DENTAL 20121130 OTC MONOGRAPH FINAL part355 Itena Clinical SODIUM FLUORIDE .07 g/28.35g E 20171231 52904-430_467fa578-bb0b-48dd-b5e2-36e5e9829c96 52904-430 HUMAN OTC DRUG Allergy Relief Non Drowsy Loratadine TABLET ORAL 20121015 ANDA ANDA077153 Select Corporation LORATADINE 10 mg/1 N 20181231 52904-443_5fb1e4e8-81a7-4644-ba6e-ab3197e045b3 52904-443 HUMAN OTC DRUG Stomach Relief Anti Diarrheal LOPERAMIDE HYDROCHLORIDE TABLET ORAL 20121015 ANDA ANDA074091 Select Corporation LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 52904-445_d7246931-0404-4c47-826a-f9c448663116 52904-445 HUMAN OTC DRUG Pain Relief PM Nightime Sleep Aid Acetaminophen,Diphenhydramine HCl TABLET, COATED ORAL 20121015 OTC MONOGRAPH NOT FINAL part348 Select Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 52904-446_f7cedd09-39f0-4e3c-a6e6-d8b00da2075e 52904-446 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20121015 OTC MONOGRAPH NOT FINAL part343 Select Corporation ACETAMINOPHEN 500 mg/1 E 20171231 52904-447_9b05aa4c-903e-43ec-a79f-ec675bc6e77a 52904-447 HUMAN OTC DRUG Pain Relief IBUPROFEN TABLET ORAL 20121015 ANDA ANDA091239 Select Corporation IBUPROFEN 200 mg/1 N 20181231 52904-448_a3f26a2a-f404-4d48-bbae-0ee263ff409b 52904-448 HUMAN OTC DRUG Heartburn Relief FAMOTIDINE TABLET ORAL 20140314 ANDA ANDA077146 Select Corporation FAMOTIDINE 10 mg/1 N 20181231 52904-455_87b3e0da-482d-4cbb-aff7-6b147259e67a 52904-455 HUMAN OTC DRUG Sinus Relief Severe Congestion Acetaminophen,Guaifenesin, Phenylephrine HCl TABLET ORAL 20121015 OTC MONOGRAPH FINAL part341 Select Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN 325; 5; 200 mg/1; mg/1; mg/1 N 20181231 52904-456_54839955-9752-4d0c-8de8-051c3e1f40ef 52904-456 HUMAN OTC DRUG Cold Relief Severe Pain Cough Acetaminophen,Guaifenesin, Phenylephrine HCl, Dextromethorphan Hydrobromide TABLET ORAL 20121015 OTC MONOGRAPH FINAL part341 Select Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 325; 5; 200; 15 mg/1; mg/1; mg/1; mg/1 N 20181231 52904-457_20ec419a-7112-4ba7-a0ec-da4dc0100e39 52904-457 HUMAN OTC DRUG Allergy Relief Multisymptom Acetaminophen,Chlorpheniramine Maleate, Phenylephrine HCl TABLET, COATED ORAL 20121015 OTC MONOGRAPH FINAL part341 Select Corporation ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 52904-460_249fe75a-9f9e-4e59-985b-b49fe3c3c60f 52904-460 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20121015 OTC MONOGRAPH FINAL part341 Select Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 52904-468_f2f10382-7393-4c08-848a-6cbb96187e8a 52904-468 HUMAN OTC DRUG Pain Relief Maximum Strength Acetaminophen,Aspirin,Caffeine TABLET, COATED ORAL 20121015 OTC MONOGRAPH NOT FINAL part343 Select Corporation ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 52904-470_3e14dfb0-e890-4e1f-9d45-851240ce33db 52904-470 HUMAN OTC DRUG Allertness Aid Caffeine TABLET ORAL 20121015 OTC MONOGRAPH FINAL part340 Select Corporation CAFFEINE 200 mg/1 N 20181231 52904-486_5cfb8979-277a-418e-800e-11dd0c0ed783 52904-486 HUMAN OTC DRUG Pain Relief Anti inflammatory IBUPROFEN TABLET ORAL 20121015 ANDA ANDA091239 Select Corporation IBUPROFEN 200 mg/1 N 20181231 52904-493_ae5d9540-a988-4072-9a46-b2bfcb4fd3a1 52904-493 HUMAN OTC DRUG Sinus Relief Headache Nasal Acetaminophen,Phenylephrine HCl TABLET ORAL 20121015 OTC MONOGRAPH FINAL part341 Select Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 52915-010_9e852356-81c0-4373-b9f3-845a444c7a22 52915-010 HUMAN OTC DRUG ECZEMA OATMEAL LOTION/SHAMPOO TOPICAL 20121001 OTC MONOGRAPH FINAL part347 ORGANIC & SUSTAINABLE BEAUTY OATMEAL 10 mg/mL E 20171231 52915-030_666eda40-300d-4238-a632-379373a110a5 52915-030 HUMAN OTC DRUG SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN TITANIUM DIOXIDE LOTION/SHAMPOO TOPICAL 20150831 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY TITANIUM DIOXIDE 120 mg/g E 20171231 52915-040_64c24fff-56a1-4038-8dcb-502fc21f4b43 52915-040 HUMAN OTC DRUG SPF30 SUMMER BLEND SUNSCREEN TITANIUM DIOXIDE LOTION/SHAMPOO TOPICAL 20100401 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY TITANIUM DIOXIDE 120 mg/g E 20171231 52915-050_66e1a14e-221b-40cf-9af3-a15c02180f85 52915-050 HUMAN OTC DRUG SPF30 SUPER SENSITIVE SUNSCREEN TITANIUM DIOXIDE LOTION/SHAMPOO TOPICAL 20150831 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY TITANIUM DIOXIDE 120 mg/g E 20171231 52915-060_1bd5d262-c0d8-4653-9432-de3f0064612b 52915-060 HUMAN OTC DRUG SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN TITANIUM DIOXIDE STICK TOPICAL 20110401 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY TITANIUM DIOXIDE 170 mg/g E 20171231 52915-070_069627d7-ecb8-4603-a1b0-95266b77aa73 52915-070 HUMAN OTC DRUG SPF30 SUPER SENSITIVE SUNSCREEN TITANIUM DIOXIDE STICK TOPICAL 20110401 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY TITANIUM DIOXIDE 170 mg/g E 20171231 52915-100_b0a8d39c-db61-472f-94f7-2c289c0fbba8 52915-100 HUMAN OTC DRUG CALMING DIAPER RASH ZINC OXIDE CREAM TOPICAL 20150831 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY ZINC OXIDE 120 mg/g E 20171231 52915-110_0827b7e6-6b2c-4b79-8f69-1f6a4c2cec61 52915-110 HUMAN OTC DRUG Super Sensitive Diaper Rash ZINC OXIDE CREAM TOPICAL 20150831 OTC MONOGRAPH FINAL part352 ORGANIC & SUSTAINABLE BEAUTY ZINC OXIDE 120 mg/g E 20171231 52915-120_03bb0bc9-2b95-4dc9-84de-3196d2aad161 52915-120 HUMAN OTC DRUG ECZEMA OATMEAL CREAM TOPICAL 20121201 OTC MONOGRAPH FINAL part347 ORGANIC & SUSTAINABLE BEAUTY OATMEAL 10 mg/mL E 20171231 52919-123_aea30801-f2e6-48e6-9724-21ad9201b441 52919-123 HUMAN PRESCRIPTION DRUG Lymphomyosot GERANIUM ROBERTIANUM and RORIPPA NASTURTIUM-AQUATICUM and TRIBASIC CALCIUM PHOSPHATE and LEVOTHYROXINE and INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100401 UNAPPROVED HOMEOPATHIC Hameln Pharma GmbH GERANIUM ROBERTIANUM; RORIPPA NASTURTIUM-AQUATICUM; FERROUS IODIDE; JUGLANS REGIA FLOWERING TOP; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; SODIUM SULFATE; PINUS SYLVESTRIS TOP; GENTIANA LUTEA ROOT; ARANEUS DIADEMATUS; SARSAPARILLA; TRIBASIC CALCIUM PHOSPHATE; LEVOTHYROXINE 4; 4; 12; 3; 3; 3; 3; 3; 4; 4; 4; 4; 5; 6; 6; 12; 12 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 52920-121_41514997-ced8-4066-b3dd-0f34dab78e88 52920-121 HUMAN OTC DRUG Pure Petroleum White Petroleum JELLY TOPICAL 20100310 OTC MONOGRAPH FINAL part347 Singhfam Corporation PETROLATUM 1 g/g N 20181231 52920-122_b692dfbf-9030-482a-9cc3-f66b9728b4e3 52920-122 HUMAN OTC DRUG Baby Petroleum White Petroleum JELLY TOPICAL 20101001 OTC MONOGRAPH FINAL part347 Singhfam Corporation PETROLATUM 1 g/g N 20181231 52920-123_8464acae-c276-4b48-a40d-1b8bb4e46135 52920-123 HUMAN OTC DRUG Pain Relieving Analgesic Menthol GEL TOPICAL 20090921 OTC MONOGRAPH FINAL part341 Singhfam Corporation MENTHOL 4.54 g/g N 20181231 52920-124_b027e33f-e5db-4d99-8f3a-4bf55fbce922 52920-124 HUMAN OTC DRUG Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20100310 OTC MONOGRAPH FINAL part341 Singhfam Corporation CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.7; 1.1; 1.1 g/113g; g/113g; g/113g N 20181231 52920-125_20a1c1ec-3dee-4bbc-8b81-28962d04ade2 52920-125 HUMAN OTC DRUG Pure Petroleum Cocoa Butter Scented White Petroleum JELLY TOPICAL 20121001 OTC MONOGRAPH FINAL part347 Singhfam Corporation. PETROLATUM .99 g/g N 20181231 52920-126_a4eb8b73-c171-4307-ad77-7f83afe8a90a 52920-126 HUMAN OTC DRUG Baby Petroleum White Petroleum JELLY TOPICAL 20101001 OTC MONOGRAPH FINAL part347 Singhfam Corporation PETROLATUM .99 g/g N 20181231 52920-127_1f3e59c6-e24c-670d-e054-00144ff8d46c 52920-127 HUMAN OTC DRUG Pure Petroleum Aloe with Vitamin E Oil White Petroleum JELLY TOPICAL 20150810 OTC MONOGRAPH FINAL part347 Singhfam Corporation PETROLATUM 99.9 g/100g N 20181231 52920-128_1d3411b5-96e4-2c0f-e054-00144ff8d46c 52920-128 HUMAN OTC DRUG Pure Petroleum Coconut Scented White Petroleum JELLY TOPICAL 20150810 OTC MONOGRAPH FINAL part347 Singhfam Corporation PETROLATUM 99.9 g/100g N 20181231 52920-129_1d0ac299-8770-0113-e054-00144ff88e88 52920-129 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL 50% Isopropyl Alcohol LIQUID TOPICAL 20150810 OTC MONOGRAPH NOT FINAL part333A Singhfam Corporation ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 52920-130_1d0b5bfe-3dd0-43be-e054-00144ff8d46c 52920-130 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN Isopropyl Alcohol LIQUID TOPICAL 20150810 OTC MONOGRAPH NOT FINAL part333A Singhfam Corporation ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 52920-131_1d0ba0a9-eccb-0909-e054-00144ff8d46c 52920-131 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL 70% Isopropyl Alcohol LIQUID TOPICAL 20150810 OTC MONOGRAPH NOT FINAL part333A Singhfam Corporation ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 52920-132_1d0b5bfe-3dc1-43be-e054-00144ff8d46c 52920-132 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL 70% WITH WINTERGREEN Isopropyl Alcohol LIQUID TOPICAL 20150810 OTC MONOGRAPH NOT FINAL part333A Singhfam Corporation ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 52920-133_1d0ac299-8762-0113-e054-00144ff88e88 52920-133 HUMAN OTC DRUG Chest Rub Vaporizing Action Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20150810 OTC MONOGRAPH NOT FINAL part348 Singhfam Corporation CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.8; 2.6; 1.2 g/100g; g/100g; g/100g N 20181231 52920-134_1d0ac299-8754-0113-e054-00144ff88e88 52920-134 HUMAN OTC DRUG Ice Cold Analgesic Menthol and Camphor GEL TOPICAL 20150810 OTC MONOGRAPH FINAL part341 Singhfam Corporation MENTHOL; CAMPHOR (SYNTHETIC) 2; .5 g/100g; g/100g N 20181231 52925-112_bef60c06-1fd1-4edf-b4a9-11c6a4a487f9 52925-112 HUMAN OTC DRUG VCF CONTRACEPTIVE NONOXYNOL-9 FILM, SOLUBLE VAGINAL 19880601 OTC MONOGRAPH NOT FINAL part333A APOTHECUS PHARMACEUTICAL CORP. NONOXYNOL-9 280 mg/1 N 20181231 52925-312_f4e68c6a-ed8f-4688-895e-9b27db0d11c2 52925-312 HUMAN OTC DRUG VCF CONTRACEPTIVE NONOXYNOL-9 AEROSOL, FOAM VAGINAL 19970601 OTC MONOGRAPH NOT FINAL part333A APOTHECUS PHARMACEUTICAL CORP NONOXYNOL-9 125 mg/g N 20181231 52925-512_fe56207b-acf9-4ad9-b7c4-1da1112e9134 52925-512 HUMAN OTC DRUG VCF CONTRACEPTIVE PRE-FILLED APPLICATORS NONOXYNOL-9 GEL, METERED VAGINAL 20140601 OTC MONOGRAPH NOT FINAL part333A APOTHECUS PHARMACEUTICAL CORP NONOXYNOL-9 4 g/100g N 20181231 52927-200_56e7d6ee-0c00-46d0-a7fb-2dab60b3199f 52927-200 HUMAN OTC DRUG PIONA HYDROQUINONE LOTION TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part358A Grand Stream Enterprise, Inc HYDROQUINONE 1.95 1/100mL E 20171231 52936-001_455a4dc7-dd42-5be6-e054-00144ff88e88 52936-001 HUMAN OTC DRUG ULTRA STRENGTH PAIN RELIEF CAMPHOR, MENTHOL OINTMENT TOPICAL 20150716 20181001 OTC MONOGRAPH NOT FINAL part348 Planet (Shanghai) International Co., Ltd. CAMPHOR (SYNTHETIC); MENTHOL 11; 11 g/100g; g/100g N 20181231 52937-001_37b6f1f8-f99d-4ff4-b199-e1806f597479 52937-001 HUMAN PRESCRIPTION DRUG Vascepa icosapent ethyl CAPSULE ORAL 20121001 NDA NDA202057 Amarin Pharma Inc. ICOSAPENT ETHYL 1000 mg/1 N 20181231 52937-003_37b6f1f8-f99d-4ff4-b199-e1806f597479 52937-003 HUMAN PRESCRIPTION DRUG Vascepa icosapent ethyl CAPSULE ORAL 20160916 NDA NDA202057 Amarin Pharma Inc. ICOSAPENT ETHYL 500 mg/1 N 20181231 52937-101_37b6f1f8-f99d-4ff4-b199-e1806f597479 52937-101 HUMAN PRESCRIPTION DRUG Vascepa icosapent ethyl CAPSULE ORAL 20121001 NDA NDA202057 Amarin Pharma Inc. ICOSAPENT ETHYL 1000 mg/1 N 20181231 52959-003_a2c3b08c-f9ce-4ff2-b26a-8aba341de515 52959-003 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 H.J. Harkins Company, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 CIII E 20171231 52959-008_a90b16ab-0c90-4e42-a281-7989f2158ebe 52959-008 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 H.J. Harkins Company, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 52959-009_8a441358-7fed-46d1-9401-ba50193cc639 52959-009 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 H.J. Harkins Company, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52959-011_28d573ee-7c75-40c4-ac13-125339ea9269 52959-011 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 H.J. Harkins Company, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 52959-014_2501c5c7-df08-4d3a-8ee6-6c28e3c985f9 52959-014 HUMAN OTC DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Neomycin and Polymyxin B Sulfates and Bacitracin Zinc OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B H.J. Harkins Company, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 52959-018_b761ebd8-e9bb-46d1-9671-8e59373f51f6 52959-018 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 H.J. Harkins Company, Inc. ASPIRIN 325 mg/1 N 20181231 52959-020_28d573ee-7c75-40c4-ac13-125339ea9269 52959-020 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 H.J. Harkins Company, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 52959-026_8baadcf8-d2c4-40c6-9fa0-485a0d699745 52959-026 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19960124 ANDA ANDA040124 H.J. Harkins Company, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 52959-028_400e1d37-ae36-4c98-95fb-59732443853c 52959-028 HUMAN OTC DRUG Menthol and Methyl Salicylate Menthol and Methyl Salicylate STICK TOPICAL 19910601 OTC MONOGRAPH NOT FINAL part348 H.J. Harkins Company, Inc. MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 52959-030_87894a01-9fab-4362-b6d4-f9a5f6a88d0f 52959-030 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051201 ANDA ANDA065229 H.J. Harkins Company, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52959-031_749fe83a-d77e-46c1-8f31-6f318af9a2da 52959-031 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 H.J. Harkins Company, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52959-033_dda3a80a-8f5f-4502-ac2c-d4ac81fab9ce 52959-033 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20100604 ANDA ANDA040659 H.J. Harkins Company, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 52959-034_1d7bd683-a263-467b-ac59-22f200b04aef 52959-034 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 H.J. Harkins Company, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 52959-041_7a471140-a07a-4ee7-926c-824f568ae061 52959-041 HUMAN OTC DRUG LiquiTears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20111209 OTC MONOGRAPH FINAL part349 H.J. Harkins Company, Inc. POLYVINYL ALCOHOL 14 mg/mL E 20171231 52959-042_5da7b877-db35-d9af-e053-2a91aa0aa7a0 52959-042 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20170103 ANDA ANDA077797 H. J Harkins Company Inc CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 52959-049_8ff3da59-a3a2-4b6b-9445-3e578afe500e 52959-049 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20110120 ANDA ANDA062286 H.J. Harkins Company, Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 52959-053_dd6764ad-1dcd-457a-a31a-5fb041c83a7f 52959-053 HUMAN OTC DRUG Diphenhydramine Diphenhydramine Hydrochloride CAPSULE ORAL 20110817 OTC MONOGRAPH FINAL part348 H.J. Harkins Company, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 E 20171231 52959-054_bd1cea53-2311-499a-a9f0-8473ff0bdc14 52959-054 HUMAN OTC DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B H.J. Harkins Company, Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 1000 [USP'U]/g; [USP'U]/g N 20181231 52959-055_7f84a5cf-17aa-4078-ba9c-89dfb8ea349b 52959-055 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19841107 ANDA ANDA062396 H.J. Harkins Company, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 52959-074_104d12ea-e22c-46e6-b3c6-7bb45c4c01c9 52959-074 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 H.J. Harkins Company, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 52959-075_cc7aabc5-f1ea-49d9-ba81-267b65bbbef4 52959-075 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 H.J. Harkins Company, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52959-076_eb1eee33-fb71-41fc-9a72-162d81554a16 52959-076 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 H.J. Harkins Company, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52959-077_eb1eee33-fb71-41fc-9a72-162d81554a16 52959-077 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 H.J. Harkins Company, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52959-082_60cd54b1-0806-8b86-e053-2a91aa0a1458 52959-082 HUMAN PRESCRIPTION DRUG INDOMETHACIN EXTENDED-RELEASE INDOMETHACIN EXTENDED-RELEASE CAPSULE ORAL 20170221 ANDA ANDA202706 H. J. Harkins Company inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52959-084_36912c86-f160-4e1b-8fef-a0552745e1c3 52959-084 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 H.J. Harkins Company, Inc. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 52959-085_f32260ef-31d9-4446-9111-ed69225e75fc 52959-085 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 H.J. Harkins Company, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52959-088_3cdbfc16-f665-44dd-be3f-2053f5efd394 52959-088 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C H.J. Harkins Company, Inc. CLOTRIMAZOLE 1 g/100g N 20181231 52959-089_663612a7-60b5-43b7-9b9a-91cff028cb97 52959-089 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 H.J. Harkins Company, Inc. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 52959-095_0806c64e-e77d-4aa8-ad24-67714b5c5148 52959-095 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part348 H.J. Harkins Company, Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 5; .0375 g/100g; g/100g; g/100g E 20171231 52959-096_0899cb6a-c841-479f-aabb-28560c1fda74 52959-096 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20060928 ANDA ANDA086414 H.J. Harkins Company, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52959-099_70dca5f7-12fd-4c32-860c-d814f646c769 52959-099 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19871101 ANDA ANDA084276 H.J. Harkins Company, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 52959-102_9a58a7ae-3045-4b63-bd19-97f74582edc3 52959-102 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20111007 ANDA ANDA070033 H.J. Harkins Company, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 52959-108_859bbd86-adb6-433d-8ff5-71a754b306b7 52959-108 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19931129 ANDA ANDA064052 H.J. Harkins Company, Inc. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 52959-113_cad74dc9-a202-4e5d-b927-b2251079a170 52959-113 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20100108 OTC MONOGRAPH FINAL part333B H.J. Harkins Company, Inc. BACITRACIN ZINC 500 [USP'U]/g N 20181231 52959-116_01a96480-6037-4c00-8f36-f3413fd796df 52959-116 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 H.J. Harkins Company, Inc. FAMOTIDINE 40 mg/1 E 20171231 52959-117_629fd51c-0ad7-4ea2-9661-1d654bcbbd17 52959-117 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SOLUTION OPHTHALMIC 20030325 ANDA ANDA089560 H.J. Harkins Company, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 52959-119_91b582b6-c0b5-477e-bf84-cb198a6151bd 52959-119 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040778 H.J. Harkins Company, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 52959-122_76f29754-8711-434f-9548-837d2d608cfd 52959-122 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL 20100910 UNAPPROVED DRUG OTHER H.J. Harkins Company, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 E 20171231 52959-124_cfb7782a-0363-4ea1-a7cc-259afa5336d1 52959-124 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20080923 ANDA ANDA078930 H.J. Harkins Company, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52959-126_65be80e7-696c-4442-a683-38bbb6eddcba 52959-126 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 H.J. Harkins Company, Inc. PREDNISONE 10 mg/1 N 20181231 52959-127_0fbab6d8-b9d9-4e8a-8023-3df614071406 52959-127 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 H.J. Harkins Company, Inc. PREDNISONE 20 mg/1 N 20181231 52959-129_85ad079e-088c-493d-bd2a-deaa107391bc 52959-129 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20070131 ANDA ANDA077712 H.J. Harkins Company, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-130_0438b837-f7ec-4c37-ae80-eafff9e3360b 52959-130 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 H.J. Harkins Company, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-131_85ad079e-088c-493d-bd2a-deaa107391bc 52959-131 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20090302 ANDA ANDA077712 H.J. Harkins Company, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-132_150cd716-8f3b-4890-807f-8a54ecc9e183 52959-132 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 H.J. Harkins Company, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 52959-134_71d6b94b-c32f-441c-89d5-a105afab79ea 52959-134 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080823 ANDA ANDA065434 H.J. Harkins Company, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52959-138_3ac644a7-eb27-4023-b211-d9ed9c38c4e8 52959-138 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022195 H.J. Harkins Company, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 52959-144_7b3d09bc-e5df-4fcf-941b-c19686900623 52959-144 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 H.J. Harkins Company, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 52959-145_aa8209f7-358e-4f9c-aaaf-1bde912f0a68 52959-145 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19810714 ANDA ANDA087425 H.J. Harkins Company, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 52959-159_525aa3b8-7fde-4683-959e-d3da10140cb1 52959-159 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20060811 ANDA ANDA076369 H.J. Harkins Company, Inc. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] E 20171231 52959-167_70dca5f7-12fd-4c32-860c-d814f646c769 52959-167 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19871101 ANDA ANDA084277 H.J. Harkins Company, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 52959-168_5fb0acc3-3e30-732e-e053-2a91aa0af3cc 52959-168 HUMAN PRESCRIPTION DRUG DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE CAPSULE ORAL 20170103 ANDA ANDA040319 H.J. Harkins Company inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 52959-182_3ac644a7-eb27-4023-b211-d9ed9c38c4e8 52959-182 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022195 H.J. Harkins Company, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 52959-185_a0844f71-fb93-4a00-9908-dad2df9fdae7 52959-185 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 H.J. Harkins Company, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-187_6608c82e-6913-4928-b4fb-3815863ce2d0 52959-187 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 H.J. Harkins Company, Inc. IBUPROFEN 200 mg/1 E 20171231 52959-191_e0716b0d-f797-4807-a4ef-81e8262b246f 52959-191 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 H.J. Harkins Company, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-195_91275e67-c112-480e-b4c9-1de9f51ac081 52959-195 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071795 H.J. Harkins Company, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52959-204_68fe3dfd-c27f-4558-b1b1-6aff37213809 52959-204 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20070905 ANDA ANDA078251 H.J. Harkins Company, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 52959-219_7ec07ddf-81e2-435e-8836-0fb4e238fe35 52959-219 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 H.J. Harkins Company, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] E 20171231 52959-220_0781aefd-3c65-4a2f-9369-661c7c4bfe70 52959-220 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 H.J. Harkins Company, Inc. PREDNISONE 5 mg/1 N 20181231 52959-220_5fb1c200-5919-6699-e053-2a91aa0a5208 52959-220 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20171116 ANDA ANDA040256 H. J. Harkins Company Inc. PREDNISONE 5 mg/1 N 20181231 52959-221_c5e71cb1-0d6c-47fa-b809-2182932ab3db 52959-221 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 H.J. Harkins Company, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 52959-225_8602b88e-b064-49c4-a224-11829d706003 52959-225 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087127 H.J. Harkins Company, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 52959-232_bd59acb2-4996-4167-a558-00c59a0653d0 52959-232 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20120416 ANDA ANDA074131 H.J. Harkins Company, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-236_534aaa8b-7a83-4a14-9c08-c1972632fc26 52959-236 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA071108 H.J. Harkins Company, Inc. FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 52959-245_5fdf2c0a-67e1-44ca-9561-2caaf8d5ec9b 52959-245 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20110118 ANDA ANDA073516 H.J. Harkins Company, Inc. KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-260_68ccbad3-6dd8-41d3-8eb2-7babb7d1a44a 52959-260 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 H.J. Harkins Company, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 E 20171231 52959-265_fceefb90-8d05-40f0-b612-107685339aff 52959-265 HUMAN PRESCRIPTION DRUG PREDNISOLONE ACETATE prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19970819 NDA AUTHORIZED GENERIC NDA017011 H.J. Harkins Company, Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52959-271_454a1424-a79e-4678-b54f-ea82d88a123e 52959-271 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen TABLET ORAL 20070701 ANDA ANDA078250 H.J. Harkins Company, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-282_fc96693f-ed3b-4a38-b082-f7e43df9de65 52959-282 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 H.J. Harkins Company, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 52959-289_a0862d45-3327-433a-9d0d-2928a4327527 52959-289 HUMAN PRESCRIPTION DRUG VIRACEPT nelfinavir mesylate TABLET, FILM COATED ORAL 19970314 NDA NDA020779 H.J. Harkins Company, Inc. NELFINAVIR MESYLATE 250 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] N 20181231 52959-296_7062e52f-035a-4d55-ba37-1b8ccc0ed7ef 52959-296 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 H.J. Harkins Company, Inc. AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 52959-298_f91e8d59-64bf-479c-b56a-f9e55489940d 52959-298 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 19990207 ANDA ANDA074937 H.J. Harkins Company, Inc. IBUPROFEN 100 mg/5mL E 20171231 52959-300_e39e2622-3fbf-474b-9c32-f052dc1a7eb2 52959-300 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20051208 ANDA ANDA065276 H. J. Harkins Company, Inc. CEFPROZIL 500 mg/1 E 20171231 52959-301_78d48e3a-2b53-489c-8961-3444d25a4a6c 52959-301 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 H.J. Harkins Company, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 52959-303_dbcf8a7d-54ef-41ef-b7d6-7b0ad073a7b4 52959-303 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA077135 H.J. Harkins Company, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 52959-305_bf8b4d41-0381-4c4e-9f08-0adf34f0e98c 52959-305 HUMAN PRESCRIPTION DRUG Rimantadine Hydrochloride Rimantadine Hydrochloride TABLET, FILM COATED ORAL 20050401 ANDA ANDA076132 H.J. Harkins Company, Inc. RIMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 52959-308_14405431-115c-417b-918e-17a63bb6042a 52959-308 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET, FILM COATED ORAL 20101201 ANDA ANDA065496 H.J. Harkins Company, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52959-309_c0665cc5-d9f4-406b-b3c3-3b1c751de3d5 52959-309 HUMAN OTC DRUG Acetaminophen Acetaminophen LIQUID ORAL 19940905 OTC MONOGRAPH NOT FINAL part343 H.J. Harkins Company, Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 52959-311_5e218569-5517-fe64-e053-2991aa0a36c5 52959-311 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20170103 NDA NDA018877 H. J. Harkins Company Inc ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 52959-329_5cef4e41-dc16-6148-e053-2a91aa0a6d0e 52959-329 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170103 ANDA ANDA091680 H.J. Harkins Company, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 52959-336_b921807d-5d59-4548-af3c-4152820b1465 52959-336 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100323 ANDA ANDA060704 H.J. Harkins Company, Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 52959-338_976d0a7b-0607-453e-82df-3eb3fa19d1ce 52959-338 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET, FILM COATED ORAL 20110504 OTC MONOGRAPH FINAL part343 H.J. Harkins Company, Inc. ACETAMINOPHEN 500 mg/1 E 20171231 52959-348_a90b16ab-0c90-4e42-a281-7989f2158ebe 52959-348 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 H.J. Harkins Company, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 52959-370_463f3a60-1b30-4487-be79-2aa3cea75a51 52959-370 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 19790605 ANDA ANDA086162 H.J. Harkins Company BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 52959-379_60e0ecab-9d00-3b1b-e053-2a91aa0af663 52959-379 HUMAN PRESCRIPTION DRUG DIFLUNISAL DIFLUNISAL TABLET, FILM COATED ORAL 20171222 ANDA ANDA073673 H. J. Harkins Company Inc. DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52959-386_8a7832fd-a24f-43b5-b46c-6043dfb24114 52959-386 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 H.J. Harkins Company Inc. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-389_8cd46ed0-6629-479f-9c35-22fbeb811d71 52959-389 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19880225 ANDA ANDA062882 H.J. Harkins Company, Inc. AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 52959-392_32aeebab-9a83-4b11-8f29-a5e1fa2dc274 52959-392 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088160 H.J. Harkins Company, Inc. DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52959-398_bd59acb2-4996-4167-a558-00c59a0653d0 52959-398 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20120416 ANDA ANDA074131 H.J. Harkins Company, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-400_9a58a7ae-3045-4b63-bd19-97f74582edc3 52959-400 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20111007 ANDA ANDA070027 H.J. Harkins Company, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 52959-406_a0844f71-fb93-4a00-9908-dad2df9fdae7 52959-406 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 H.J. Harkins Company, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-408_0a9c8629-be18-4f5d-8f19-e96b46d63dbd 52959-408 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 H.J. Harkins Company, Inc. HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 52959-410_1f3bb40a-4eff-4c11-b55b-89a3f8425118 52959-410 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 H.J. Harkins Company, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 52959-411_1f3bb40a-4eff-4c11-b55b-89a3f8425118 52959-411 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 H.J. Harkins Company, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 52959-413_0a9c8629-be18-4f5d-8f19-e96b46d63dbd 52959-413 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA077471 H.J. Harkins Company, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 52959-420_0a9c8629-be18-4f5d-8f19-e96b46d63dbd 52959-420 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 H.J. Harkins Company, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 52959-423_6029c68a-8374-48c7-8690-74347e623cfe 52959-423 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 H.J. Harkins Company, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-425_5fb211f6-c675-4dea-e053-2a91aa0ac51a 52959-425 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20170103 ANDA ANDA090469 H. J. Harkins Company Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 52959-428_142c98e2-4356-4f18-a596-90fddd02d067 52959-428 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080401 ANDA ANDA065392 H.J. Harkins Company, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52959-432_39c69ed9-e45d-4099-b249-ddf710527e3c 52959-432 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 H.J. Harkins Company, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 52959-433_f261ce7f-663b-4ca6-9ee3-215ec8eeb9c4 52959-433 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20100701 ANDA ANDA088496 H.J. Harkins Company, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 52959-435_8a7832fd-a24f-43b5-b46c-6043dfb24114 52959-435 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 H.J. Harkins Company Inc. METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-441_7e3a6da2-f432-4a62-ab53-c305587b7726 52959-441 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 H.J. Harkins Company, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 52959-450_9d232871-21b7-423b-8c70-ed1bdd8901a0 52959-450 HUMAN PRESCRIPTION DRUG Next Choice levonorgestrel TABLET ORAL 20090904 ANDA ANDA078665 H.J. Harkins Company, Inc. LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] E 20171231 52959-459_54f020bf-54a5-4a05-98f2-c7ca8e25be3f 52959-459 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 H.J. Harkins Company, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52959-463_c9ff7aa4-60d8-40e5-867a-f5af6cefe49a 52959-463 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 H.J. Harkins Company, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 52959-466_f145684a-097f-472a-a9fb-ed6c513cdc71 52959-466 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 H.J. Harkins Company, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 52959-469_2f8a9fb7-d0df-4362-a206-38c6a4291fd6 52959-469 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET ORAL 19970109 ANDA ANDA074661 H.J. Harkins Company, Inc. NAPROXEN SODIUM 220 mg/1 E 20171231 52959-471_fa86884d-639e-4a55-8038-650350c81462 52959-471 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 H.J. Harkins Company, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-481_5f140045-e8ea-28c2-e053-2991aa0a46cc 52959-481 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET ORAL 20170103 ANDA ANDA204279 H.J Harkins Company inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 52959-510_cf6af122-0acc-4dcf-8d52-5f283c6f0666 52959-510 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 H.J. Harkins Company, Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 52959-512_8e1a80b4-ffb1-424c-b35d-4986fa74e21f 52959-512 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 H.J. Harkins Company, Inc. KETOROLAC TROMETHAMINE 10 mg/1 E 20171231 52959-514_a90b16ab-0c90-4e42-a281-7989f2158ebe 52959-514 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 H.J. Harkins Company, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 52959-516_8aaccad1-9c53-4d0d-a05f-b1a1f7c77d1f 52959-516 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20100923 ANDA ANDA075227 H.J. Harkins Company, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-517_316f8dac-8a38-4351-819e-9e5d5fc38c50 52959-517 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20110527 ANDA ANDA074578 H.J. Harkins Company, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 52959-518_94fc9e99-c19d-4e8c-91be-b469ec44513d 52959-518 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20080114 NDA NDA021234 H.J. Harkins Company, Inc. DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-527_2637a5d7-26be-4a9b-ad46-b9d96d929e3c 52959-527 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 20000623 ANDA ANDA040368 H.J. Harkins Company, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 52959-534_d6d3bcd7-acb0-47a0-a19c-33be09363bb3 52959-534 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 H.J. Harkins Company, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 52959-535_54f020bf-54a5-4a05-98f2-c7ca8e25be3f 52959-535 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 H.J. Harkins Company, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52959-539_fa8f4605-2a86-49f2-8a42-d706ce01a5b0 52959-539 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 H.J. Harkins Company, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-540_fa8f4605-2a86-49f2-8a42-d706ce01a5b0 52959-540 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 H.J. Harkins Company, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-544_5e218603-4810-d859-e053-2991aa0a7241 52959-544 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20170103 ANDA ANDA074556 H.J. Harkins Company Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 52959-546_37641156-8d51-4e36-abb6-b46cb9e7f828 52959-546 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 20101019 NDA NDA020857 H.J. Harkins Company, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 52959-547_32aeebab-9a83-4b11-8f29-a5e1fa2dc274 52959-547 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088238 H.J. Harkins Company, Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52959-548_319f79f5-a83e-4c51-b362-c01eb43d5ed6 52959-548 HUMAN PRESCRIPTION DRUG Transmucosal Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20060906 NDA NDA020747 H.J. Harkins Company, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-549_319f79f5-a83e-4c51-b362-c01eb43d5ed6 52959-549 HUMAN PRESCRIPTION DRUG Transmucosal Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20060906 NDA NDA020747 H.J. Harkins Company, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-556_4bedcdef-76de-40e6-ad2b-241fbb6fabe7 52959-556 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 19960730 ANDA ANDA040105 H.J. Harkins Company, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-557_a00f72d8-4467-49b3-b8c5-51789b941b7f 52959-557 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 H.J. Harkins Company, Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 52959-558_7f846eba-4489-4e7d-85fc-586ac9830380 52959-558 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364 H.J. Harkins Company, Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52959-566_319f79f5-a83e-4c51-b362-c01eb43d5ed6 52959-566 HUMAN PRESCRIPTION DRUG Transmucosal Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20060906 NDA NDA020747 H.J. Harkins Company, Inc. FENTANYL CITRATE 1200 1/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-579_b13e2d13-40f5-49d3-8558-4ac6186eb853 52959-579 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19970623 NDA NDA020592 H.J. Harkins Company, Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 52959-585_62e84ab2-d304-4595-a918-6939ea7cc7b7 52959-585 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 H.J. Harkins Company, Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-593_360650e7-757b-462f-8518-ffc103c71bc7 52959-593 HUMAN PRESCRIPTION DRUG Multi-Vitamin Fluoride Drops Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B12, Niacin, Vitamin B6, Flouride SOLUTION ORAL 20110504 UNAPPROVED DRUG OTHER H.J. Harkins Company, Inc. VITAMIN A; THIAMINE; RIBOFLAVIN; ASCORBIC ACID; CHOLECALCIFEROL; NIACIN; PYRIDOXINE; CYANOCOBALAMIN; FLUORIDE ION; .ALPHA.-TOCOPHEROL SUCCINATE, D- 1500; .5; .6; 35; 400; 8; .4; 2; .25; 5 [iU]/mL; mg/mL; mg/mL; mg/mL; [iU]/mL; mg/mL; mg/mL; ug/mL; mg/mL; [iU]/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 52959-595_db7aec8b-4f85-4358-ba86-b5cbffb6a986 52959-595 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 H.J. Harkins Company, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 52959-596_96bd5ba7-4885-4069-976d-eb4949445264 52959-596 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 H.J. Harkins Company, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 52959-604_5faa9dae-bc3e-4a04-8909-94d8133f8e53 52959-604 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 H.J. Harkins Company, Inc. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 52959-609_998080ce-a00c-4518-92fd-a985679ad681 52959-609 HUMAN PRESCRIPTION DRUG POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate SOLUTION/ DROPS OPHTHALMIC 19970429 NDA AUTHORIZED GENERIC NDA050567 H.J. Harkins Company, Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 52959-613_f97f68a9-f15b-4a49-8a24-89b2e31992cb 52959-613 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 H.J. Harkins Company, Inc. AMOXICILLIN 250 mg/5mL E 20171231 52959-620_2d3e1047-9978-4400-a4bd-76aff63420a6 52959-620 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin FOR SUSPENSION ORAL 20050801 ANDA ANDA065234 H.J. Harkins Company, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52959-629_0e8477f6-fc7d-4ccd-a064-5c5d75f331af 52959-629 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20110721 NDA NDA021366 H.J. Harkins Company, Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 52959-630_8a441358-7fed-46d1-9401-ba50193cc639 52959-630 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 H.J. Harkins Company, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52959-635_e76af339-d18b-4736-8c5f-571f0fdef293 52959-635 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19970918 NDA NDA018578 H.J. Harkins Company, Inc. SILVER SULFADIAZINE 10 g/1000g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 52959-643_1e56d689-84c0-41f2-a236-b02329ad276a 52959-643 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 H.J. Harkins Company, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 52959-649_5566541f-5f89-2902-e054-00144ff88e88 52959-649 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170306 ANDA ANDA091134 H.J. HARKINS COMPANY, INC. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52959-650_0ebcf6fc-a0cf-491d-b833-42ac160dc5e0 52959-650 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 H.J. Harkins Company, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-652_baed54e9-abeb-436b-bb53-114bd11e8001 52959-652 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide GEL TOPICAL 20110120 ANDA ANDA072537 H.J. Harkins Company, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52959-653_0a0823ba-8547-46bb-84de-076196f6a913 52959-653 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE, COATED ORAL 20010701 ANDA ANDA065028 H.J. Harkins Company, Inc. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 52959-655_1a55e010-4f16-4082-be02-77d7777f8c09 52959-655 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 H.J. Harkins Company, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 52959-656_0ebcf6fc-a0cf-491d-b833-42ac160dc5e0 52959-656 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 H.J. Harkins Company, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-658_724f7d0e-6859-4bb9-abd5-8d3cd456475a 52959-658 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 H.J. Harkins Company, Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 52959-659_a346079a-144b-47b0-ba63-cd3db2c05ce2 52959-659 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 20100121 ANDA ANDA075219 H.J. Harkins Company, Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-662_809b4fca-b61c-4d90-93f6-745346012c86 52959-662 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20110504 ANDA ANDA070791 H.J. Harkins Company, Inc. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 52959-675_e57a4e72-fd3d-44fa-96ca-06ea1d477cc8 52959-675 HUMAN OTC DRUG SENEXON-S DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20110316 OTC MONOGRAPH NOT FINAL part334 H.J. Harkins Company, Inc. DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 N 20181231 52959-676_d48ce370-755e-4da3-bd60-fd91433924ae 52959-676 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20101223 ANDA ANDA075022 H.J. Harkins Company, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 E 20171231 52959-677_0d3ec116-a621-4f15-bc56-c63487a319bc 52959-677 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072235 H.J. Harkins Company, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 52959-688_5d544cbc-94c2-6194-e053-2991aa0ada36 52959-688 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET ORAL 20170103 ANDA ANDA090404 H.J. Harkins Company Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 52959-689_efa8102d-2da1-4d92-b884-fd9c8bd80383 52959-689 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 H.J. Harkins Company, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 52959-691_efa8102d-2da1-4d92-b884-fd9c8bd80383 52959-691 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 H.J. Harkins Company, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 52959-692_9355aee3-c2a5-485f-ae95-cf93bfc0a57f 52959-692 HUMAN PRESCRIPTION DRUG misoprostol misoprostol TABLET ORAL 20091227 NDA NDA019268 H.J. Harkins Company, Inc. MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 52959-702_9404bff5-10f1-4359-8894-b6a5cb5ae198 52959-702 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20110125 ANDA ANDA065101 H.J. Harkins Company, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 52959-705_a979a931-8857-48a2-b369-d17c814d7ece 52959-705 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19950929 ANDA ANDA040074 H.J. Harkins Company, Inc. PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] E 20171231 52959-707_9404bff5-10f1-4359-8894-b6a5cb5ae198 52959-707 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20110125 ANDA ANDA065096 H.J. Harkins Company, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 52959-718_5f89da54-a100-5ed4-e053-2991aa0a3546 52959-718 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET ORAL 20170103 ANDA ANDA091368 H. J. Harkins Company Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 52959-721_ca18345d-d08a-4be6-a006-49ecdd06ab30 52959-721 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19840226 ANDA ANDA019137 H.J. Harkins Company, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52959-722_beac7b55-14cd-45b4-8024-bd117222e6cc 52959-722 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20110114 ANDA ANDA075876 H.J. Harkins Company, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 52959-728_b6067e83-6c20-4902-84db-cf26f1c3c005 52959-728 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20051117 ANDA ANDA077321 H.J. Harkins Company, Inc. LISINOPRIL 10 mg/1 E 20171231 52959-730_9adbd7e3-4ea3-4ef7-8112-a6a0c31b4b6a 52959-730 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 H.J. Harkins Company, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 52959-731_a69a3507-3ae2-4226-86e6-3cc872ad2fdb 52959-731 HUMAN PRESCRIPTION DRUG PROMETHEGAN PROMETHAZINE HYDROCHLORIDE SUPPOSITORY RECTAL 20020228 ANDA ANDA040428 H.J. Harkins Company, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 52959-733_0d3ec116-a621-4f15-bc56-c63487a319bc 52959-733 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072234 H.J. Harkins Company, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 52959-734_5f4e80a1-0226-63dd-e053-2991aa0aa7fb 52959-734 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20170103 ANDA ANDA076639 H. J. Harkins Company Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 52959-734_9adbd7e3-4ea3-4ef7-8112-a6a0c31b4b6a 52959-734 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 H.J. Harkins Company, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 52959-737_5b4e2c4e-4e54-7794-e053-2a91aa0ab4e6 52959-737 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161230 ANDA ANDA201013 H.J. Harkins Company, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 52959-737_5f3f6e79-7f2f-4cba-9631-bdf030400172 52959-737 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 H.J. Harkins Company, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 52959-738_f6e09c02-e9e8-4099-b9cf-00d9ebac732f 52959-738 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100118 ANDA ANDA076642 H.J. Harkins Company, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII N 20181231 52959-739_9adbd7e3-4ea3-4ef7-8112-a6a0c31b4b6a 52959-739 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 H.J. Harkins Company, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 52959-740_2aadfde6-5a06-4a2c-b249-c3ff844145d4 52959-740 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 H.J. Harkins Company, Inc. LORATADINE 10 mg/1 N 20181231 52959-743_09fcfeb2-8e52-4417-86b5-63688d9ede45 52959-743 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20091030 ANDA ANDA065123 H.J. Harkins Company, Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 52959-746_4c9b2c15-78b0-42b1-a146-026282c33076 52959-746 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 H.J. Harkins Company, Inc. PREGABALIN 100 mg/1 CV N 20181231 52959-747_4c9b2c15-78b0-42b1-a146-026282c33076 52959-747 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 H.J. Harkins Company, Inc. PREGABALIN 75 mg/1 CV N 20181231 52959-757_3b0ebf5d-a084-4322-a1f4-602566b5a9c2 52959-757 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 H.J. Harkins Company, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 52959-761_8a441358-7fed-46d1-9401-ba50193cc639 52959-761 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 H.J. Harkins Company, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 52959-763_b0521d4d-afba-41bf-a921-1dc4a277e5f7 52959-763 HUMAN PRESCRIPTION DRUG ofloxacin ofloxacin SOLUTION OPHTHALMIC 20100104 ANDA ANDA078559 H.J. Harkins Company, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 52959-766_1fc8d359-d5b3-42ac-82c4-cc0ebe609198 52959-766 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19971229 ANDA ANDA074650 H.J. Harkins Company, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 52959-772_1199caa8-cf89-4168-94d1-56bd48557325 52959-772 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 H.J. Harkins Company, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 52959-773_3ccdc4a4-7388-4383-964b-1e964890e1d1 52959-773 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20090101 ANDA ANDA077031 H.J. Harkins Company, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52959-775_176f9d8a-7d2d-4830-abe6-91e32cdf58f5 52959-775 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 H.J. Harkins Company, Inc. PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52959-776_176f9d8a-7d2d-4830-abe6-91e32cdf58f5 52959-776 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 H.J. Harkins Company, Inc. PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52959-789_1199caa8-cf89-4168-94d1-56bd48557325 52959-789 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 H.J. Harkins Company, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 52959-800_f180bf54-c92f-4597-ab9c-a91543ceedf6 52959-800 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20010131 ANDA ANDA075855 H.J. Harkins Company, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 52959-803_656a1145-8596-45aa-b59e-14b986d8ff76 52959-803 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride TABLET ORAL 20100421 ANDA ANDA077699 H.J. Harkins Company, Inc. MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] N 20181231 52959-806_6587b0ef-0ce7-4dca-96fb-b07fc0155fd2 52959-806 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride BuPROPion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 H.J. Harkins Company, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 52959-811_efdfe922-d360-43bc-b65c-245178658b4a 52959-811 HUMAN PRESCRIPTION DRUG TERCONAZOLE terconazole CREAM VAGINAL 20040401 NDA NDA019579 H.J. Harkins Company, Inc. TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] E 20171231 52959-812_4dac9654-cf35-4ad6-ba88-ccabe84069b0 52959-812 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040527 H.J. Harkins Company, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20191231 52959-812_61e4300d-6f7e-6951-e053-2a91aa0a974a 52959-812 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20170718 ANDA ANDA203068 H.J. Harkins Company, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20191231 52959-814_37302f24-ba1e-4146-b42c-549a8dd0e9e3 52959-814 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED ORAL 20051216 ANDA ANDA077184 H.J. Harkins Company, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 52959-822_ad2e35e9-f17a-4a7a-a19d-bfe7af334161 52959-822 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 H.J. Harkins Company, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 52959-824_6dce31da-352d-47ef-9f8d-d4e2466a06a1 52959-824 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 H.J. Harkins Company, Inc. NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 52959-838_004b13ef-8ffb-434a-9abd-18085b6a0793 52959-838 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 H.J. Harkins Company, Inc. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 52959-846_5f8ab159-7b81-b3f2-e053-2a91aa0ae2d7 52959-846 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170103 ANDA ANDA078048 H. J. Harkins Company Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 52959-852_feff9e75-95ba-4fb3-b286-c363cf4ea678 52959-852 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 H.J. Harkins Company, Inc. ESZOPICLONE 3 mg/1 CIV E 20171231 52959-854_60a4774b-9588-19d1-e053-2a91aa0aa82d 52959-854 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20171117 ANDA ANDA076180 H. J. Harkins Company Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 52959-872_a62fcc0d-ac44-43dd-b293-8e0204d7f882 52959-872 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 H.J. Harkins Company Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52959-875_a62fcc0d-ac44-43dd-b293-8e0204d7f882 52959-875 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 H.J. Harkins Company Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52959-876_a62fcc0d-ac44-43dd-b293-8e0204d7f882 52959-876 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071218 ANDA ANDA077397 H.J. Harkins Company Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52959-879_5d59fb92-77d7-bcd0-e053-2991aa0ac409 52959-879 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20170103 ANDA ANDA077903 H.J Harkins Company Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 52959-880_67208dcd-25ba-45c9-9e5e-b71747ec6493 52959-880 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 H.J. Harkins Company, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 52959-890_ad9cf8c5-39b6-451c-9fb1-d0ec1bf08679 52959-890 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 H.J. Harkins Company, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 52959-891_4c9b2c15-78b0-42b1-a146-026282c33076 52959-891 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 H.J. Harkins Company, Inc. PREGABALIN 50 mg/1 CV N 20181231 52959-892_908e6b8e-0116-4024-bcb4-4f27938301a6 52959-892 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 H.J. Harkins Company, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 52959-897_4c9b2c15-78b0-42b1-a146-026282c33076 52959-897 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 H.J. Harkins Company, Inc. PREGABALIN 150 mg/1 CV N 20181231 52959-902_6dadb3b7-2077-4b27-b8b6-529e8698deca 52959-902 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 H.J. Harkins Company, Inc. MIRTAZAPINE 30 mg/1 N 20181231 52959-913_6c1d025f-a760-406b-80ea-b514f4dbf47d 52959-913 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030825 ANDA ANDA040513 H.J. Harkins Company, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 500; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 52959-919_feff9e75-95ba-4fb3-b286-c363cf4ea678 52959-919 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 H.J. Harkins Company, Inc. ESZOPICLONE 2 mg/1 CIV E 20171231 52959-920_663612a7-60b5-43b7-9b9a-91cff028cb97 52959-920 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 H.J. Harkins Company, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 52959-923_5f4e05af-61a5-7f84-e053-2a91aa0ac6f6 52959-923 HUMAN PRESCRIPTION DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET ORAL 20170103 ANDA ANDA077946 H. J. Harkins Company Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 52959-930_57e42715-7a47-401c-826d-2cf23e0bf6f0 52959-930 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part348 H.J. Harkins Company, Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 18; 6; .015 mL/60mL; mL/60mL; mL/60mL E 20171231 52959-939_35941438-1b02-495d-9333-f10c681f67dd 52959-939 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 H.J. Harkins Company, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 52959-940_5db5cff3-00dc-4766-abff-66800c268e61 52959-940 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, SUGAR COATED ORAL 19981231 ANDA ANDA040226 H.J. Harkins Company, Inc. PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 52959-941_7ec07ddf-81e2-435e-8836-0fb4e238fe35 52959-941 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 H.J. Harkins Company, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 52959-944_06f70227-6ba1-462b-bc45-6d4082eb3f90 52959-944 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 H.J. Harkins Company, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 52959-957_f99f26bc-5e6c-4b5a-9657-6bc3861fa5e5 52959-957 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20101215 ANDA ANDA078989 H.J. Harkins Company, Inc. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 52959-961_d9ec869c-720d-49a2-8d4c-f13a5c972e1f 52959-961 HUMAN PRESCRIPTION DRUG Halobetasol Propionate Halobetasol Propionate OINTMENT TOPICAL 20090205 ANDA ANDA076872 H.J. Harkins Company, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 52959-965_75fcb860-7243-49d6-8ae2-7cd989588e52 52959-965 HUMAN PRESCRIPTION DRUG ALPRAZOLAM EXTENDED-RELEASE ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 H.J. Harkins Company, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 52959-969_33319495-9b23-4a6e-8473-226da2b5d927 52959-969 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20040802 NDA NDA021752 H.J. Harkins Company, Inc. EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 52959-978_f3f4a975-d44b-4a91-af1a-b660b1ebb06a 52959-978 HUMAN PRESCRIPTION DRUG PROAIRHFA HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20041201 NDA NDA021457 H.J. Harkins Company, Inc. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 52959-983_be7d9791-f676-426c-ba46-6dbaced723af 52959-983 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 H.J. Harkins Company, Inc. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 52959-984_fb0e30f7-a594-40cf-b56c-a45cfbcd60d8 52959-984 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION OPHTHALMIC 20090102 NDA AUTHORIZED GENERIC NDA050592 H.J. Harkins Company, Inc. TOBRAMYCIN; DEXAMETHASONE 3; 1 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 52959-987_1fb5dcde-d854-4df6-8fc7-35affe0adc11 52959-987 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20071228 ANDA ANDA078792 H.J. Harkins Company, Inc. DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 52959-989_06f70227-6ba1-462b-bc45-6d4082eb3f90 52959-989 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 H.J. Harkins Company, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 52959-991_100ad196-b283-436d-9e09-40b89418afce 52959-991 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077517 H.J. Harkins Company, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 52959-994_7e3a6da2-f432-4a62-ab53-c305587b7726 52959-994 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 H.J. Harkins Company, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 52959-997_f19695c2-e2df-4059-9ec1-98c498baad15 52959-997 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20100101 ANDA ANDA076265 H.J. Harkins Company, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 52960-101_46279779-1009-4416-a80a-f3f94ada7d9f 52960-101 HUMAN OTC DRUG iBlanc Restora-Bright Acne Healing BENZOYL PEROXIDE CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part333D iBlanc Inc. BENZOYL PEROXIDE 5.3 g/100g E 20171231 52960-201_d21fa970-c7f7-4f19-af10-15beec658272 52960-201 HUMAN OTC DRUG iBlanc Restora-Bright Elite Natural Sun Defense SPF 30 ZINC OXIDE LOTION TOPICAL 20120923 OTC MONOGRAPH FINAL part352 iBlanc, Inc. ZINC OXIDE 13.5 g/100g E 20171231 52964-1001_4f9da83d-75f7-47c1-8bfc-9d78267c9e9a 52964-1001 HUMAN OTC DRUG BiPla SUS SCROFA PLACENTA LIQUID ORAL 20120802 UNAPPROVED DRUG OTHER TMN K.K. SUS SCROFA PLACENTA 16000 mg/30mL E 20171231 52970-010_a886da8d-2d5f-4b58-8138-e1dd0e67654d 52970-010 HUMAN OTC DRUG ROVECTIN Anti irritant Barrier Repair Ultra Dimethicone CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part347 SECOND FORMULA INC. DIMETHICONE 1.8 g/100mL E 20171231 52979-8001_37cb1daa-53df-4044-bcf3-0b860daae921 52979-8001 HUMAN OTC DRUG Angel Falls Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part333E CUARTA DIMENSION USA, INC. ALCOHOL 62 mL/100mL N 20181231 52979-8002_6e94033b-8053-4217-b6a7-6a13a1b1f2d8 52979-8002 HUMAN OTC DRUG Lemon Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part333E CUARTA DIMENSION USA, INC. ALCOHOL 62 mL/100mL N 20181231 52979-8003_807654d2-14bd-4727-9b26-be5bb3851ea9 52979-8003 HUMAN OTC DRUG Love Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part333E CUARTA DIMENSION USA, INC. ALCOHOL 62 mL/100mL N 20181231 52979-8004_af966462-4af8-4356-a71f-38c547e43189 52979-8004 HUMAN OTC DRUG Under Paris Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part333E CUARTA DIMENSION USA, INC. ALCOHOL 62 mL/100mL N 20181231 52979-8005_8f86f141-d8f6-4980-a3a3-bf4b570ef952 52979-8005 HUMAN OTC DRUG Vinotinto Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part333E CUARTA DIMENSION USA, INC. ALCOHOL 62 mL/100mL N 20181231 52979-8006_7081459b-5588-45cf-a51e-e7562e9c5a44 52979-8006 HUMAN OTC DRUG Water Mountain Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part333E CUARTA DIMENSION USA, INC. ALCOHOL 62 mL/100mL N 20181231 52982-100_99f39d62-8c04-4e61-8e95-5d350ba548f0 52982-100 HUMAN OTC DRUG Your Logo Here Antiseptic First Aid benzocaine and benzethonium chloride AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Dixon Investments, Inc. BENZOCAINE; BENZETHONIUM CHLORIDE 8500; 170 mg/85g; mg/85g E 20171231 52982-101_627ccdf1-c3e9-4ca9-945d-0945bfe4d2c6 52982-101 HUMAN OTC DRUG Your Logo Here Burn First Aid benzocaine, benzethonium chloride, and menthol AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Dixon Investments, Inc. BENZOCAINE; BENZETHONIUM CHLORIDE; MENTHOL 8500; 170; 281 mg/85g; mg/85g; mg/85g E 20171231 52982-105_411ce50b-61f6-4144-ac47-278492e9276c 52982-105 HUMAN OTC DRUG Your Logo Here Bandage Aid benzethonium chloride and benzocaine AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part333A Dixon Investments, Inc. BENZOCAINE; BENZETHONIUM CHLORIDE 2720; 170 mg/85g; mg/85g E 20171231 52982-106_e7170a92-c40d-4771-b99f-99e3371f16c3 52982-106 HUMAN OTC DRUG Your Label Here Blood Clotting First Aid benzethonium chloride and lidocaine AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Dixon Investments, Inc. LIDOCAINE; BENZETHONIUM CHLORIDE 3400; 170 mg/85g; mg/85g E 20171231 52982-107_8b2cea63-310d-4960-bbcb-4243adb855bd 52982-107 HUMAN OTC DRUG Your Logo Here Poison Ivy First Aid benzethonium chloride and benzocaine AEROSOL, SPRAY TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Dixon Investments, Inc. BENZOCAINE; BENZETHONIUM CHLORIDE 4250; 127.5 mg/85g; mg/85g E 20171231 52982-120_96b179c7-bc85-441a-a78d-774d787b1fcc 52982-120 HUMAN OTC DRUG Your Logo Here Antiseptic First Aid benzalkonium chloride and lidocaine SPRAY, METERED TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Dixon Investments, Inc. LIDOCAINE; BENZALKONIUM CHLORIDE 1912.5; 107.1 mg/90mL; mg/90mL E 20171231 52982-121_64e5cbb3-590a-4c53-bcb6-0f9e06e20dfc 52982-121 HUMAN OTC DRUG Your Logo Here Burn First Aid benzalkonium chloride and benzocaine SPRAY, METERED TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Dixon Investments, Inc. BENZOCAINE; BENZALKONIUM CHLORIDE 3825; 107.1 mg/90mL; mg/90mL E 20171231 52982-124_d1423cdc-e1b0-4d7a-bed6-cb6b218950f1 52982-124 HUMAN OTC DRUG Your Label Here Hydrogen Peroxide First Aid hydrogen peroxide SPRAY, METERED TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part356 Dixon Investments, Inc. HYDROGEN PEROXIDE 3.57 mL/119mL E 20171231 52993-001_5561332c-193a-4b77-80f4-9eb7b401c1a3 52993-001 HUMAN OTC DRUG Zinka Clear Zinc Oxide Sunscreen Octinoxate, Zinc Oxide, Octisalate, Oxybenzone LOTION TOPICAL 20070301 OTC MONOGRAPH FINAL part352 Zinka, Inc. OCTINOXATE; ZINC OXIDE; OCTISALATE; OXYBENZONE 50; 43; 30; 25 mg/g; mg/g; mg/g; mg/g N 20181231 52993-110_c7e72d26-9723-4b11-97d9-8f5b8f7f1b9b 52993-110 HUMAN OTC DRUG Zinka Lemon Twist SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Zinka OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 42 mg/g; mg/g; mg/g N 20181231 52993-111_662cac4f-c42b-4ec5-b8da-7a0819e481db 52993-111 HUMAN OTC DRUG Zinka Passion Fruit SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Zinka OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 42 mg/g; mg/g; mg/g N 20181231 52993-112_05c2271c-88a5-4b9f-81c1-8fc17778005e 52993-112 HUMAN OTC DRUG Zinka Watermelon SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Zinka OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 42 mg/g; mg/g; mg/g N 20181231 52993-125_e35d0ef5-787b-4cec-be5e-0f0c418c42fc 52993-125 HUMAN OTC DRUG Zinka Lip Protector SPF 30 Lip Balm Octinoxate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Zinka OCTINOXATE; OXYBENZONE; OCTOCRYLENE; OCTISALATE 7.5; 5; 10; 5 mg/g; mg/g; mg/g; mg/g N 20181231 52993-150_94e23afd-05ca-4f6b-82af-0bccf702f198 52993-150 HUMAN OTC DRUG Zinka SPF 50 Facestick Homosalate, Octinoxate, Octisalate, Octocrylene, Zinc Oxide STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Zinka OCTINOXATE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 4.7; 6.9; 4; 3.4; 5 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 53002-0060_7d8092ec-7b1f-4e05-8859-b65289f9c7da 53002-0060 HUMAN PRESCRIPTION DRUG valacyclovir hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120405 ANDA ANDA201506 RPK Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 53002-0080_177671a6-83cb-47cf-b517-d16f21b3f641 53002-0080 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20161015 ANDA ANDA202168 RPK Pharmaceuticals, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 53002-0150_d825e2c7-cdb4-4f2b-be1e-666227606439 53002-0150 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20061110 ANDA ANDA087385 RPK Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 53002-0270_1f4f659a-9045-44c7-92ce-e46382595c11 53002-0270 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 RPK Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 53002-0340_cdbb2051-fd3b-4948-bacf-56a097a35e88 53002-0340 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 RPK Pharmaceuticals, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 53002-0410_4fd60de2-4876-462f-9594-4663cb26d72b 53002-0410 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 RPK Pharmaceuticals, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 53002-0411_698c1cab-1c80-4b3a-94c9-bb7a0e87299e 53002-0411 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20160815 ANDA ANDA081297 RPK Pharmaceuticals, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 53002-0470_3224fcda-0a54-40ee-92e5-03d9e948d453 53002-0470 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065223 RPK Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 53002-0520_c23fc019-352d-4f97-b7a1-2f12bcd2a7db 53002-0520 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 RPK Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 53002-0570_01442c9b-990e-484b-9ecb-c24faefcdee4 53002-0570 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070727 ANDA ANDA077851 RPK Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 53002-0580_145eb43a-4b35-4f44-98ab-54d0ca4d4d41 53002-0580 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 RPK Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 53002-0590_e36ce5b0-3061-46d7-b41f-6bdb79c6da24 53002-0590 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 RPK Pharmaceuticals, Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 53002-0600_e3581322-7e12-462c-9bec-1d30c4db92a0 53002-0600 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 RPK Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 53002-0610_e99f6623-e82a-466d-b1d7-57f5d79c03fe 53002-0610 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 RPK Pharmaceuticals, Inc. PREDNISONE 5 mg/1 N 20191231 53002-0620_401b8575-2242-439c-bb73-ad1c7ef4a258 53002-0620 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 RPK Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 53002-0621_27c71228-4960-48b4-8033-018d53197a63 53002-0621 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140909 ANDA ANDA063083 RPK Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 53002-0670_069b3df0-3a36-48c2-a577-a02fb4addb65 53002-0670 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20160429 ANDA ANDA204446 RPK Pharmaceuticals, Inc. DOXYCYCLINE 100 mg/1 N 20191231 53002-1017_52aa33a8-27bf-4ff5-9329-583315d5b855 53002-1017 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 RPK Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 53002-1068_701ea9b7-3f0d-4bc6-aaf3-d323d5011406 53002-1068 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20161013 ANDA ANDA077836 RPK Pharmaceuticals, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 53002-1104_81399540-6952-4c7e-970a-cea00f4e4434 53002-1104 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 RPK Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 53002-1111_576a350e-7f24-4819-a3e4-ed766ab0238a 53002-1111 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 RPK Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 53002-1112_e9defb92-1472-4f35-a00e-a15133a856f9 53002-1112 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 RPK Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 53002-1123_4ec6618e-4aa9-4577-8552-141fa7de5456 53002-1123 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 RPK Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53002-1132_da7e87fe-b60f-492e-85f6-d7ca6e270754 53002-1132 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 RPK Pharmaceuticals, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 53002-1174_8f5644c9-727a-419b-bec3-a8d8c1e4e322 53002-1174 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 RPK Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1178_4ec6618e-4aa9-4577-8552-141fa7de5456 53002-1178 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 RPK Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53002-1192_2835a131-16b5-48f2-ba11-ba64e3fdd9ce 53002-1192 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 RPK Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1198_3e31714b-d2f9-4f89-aff7-34b1930dc362 53002-1198 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20170224 ANDA ANDA078423 RPK Pharmaceuticals, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 53002-1199_71d8d19e-8b2d-4995-b980-9ff7bd422064 53002-1199 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 RPK Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 53002-1215_2835a131-16b5-48f2-ba11-ba64e3fdd9ce 53002-1215 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 RPK Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1249_013a8447-b5df-454b-a392-9e749c62bb26 53002-1249 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 RPK Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 53002-1251_4ca8741f-24a7-4e31-94da-027adb8f9708 53002-1251 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 RPK Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 53002-1252_33e3bd96-4bce-4394-adb6-bc6c9dfeb3a1 53002-1252 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA073449 RPK Pharmaceuticals, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 53002-1259_b1af58ec-0fb1-4448-8a8a-bec786d8ffb6 53002-1259 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 RPK Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 53002-1292_86c674ec-95af-423e-be68-aa71d1ed34d9 53002-1292 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 RPK Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20191231 53002-1305_0aa9dd31-7215-42df-910e-7dd6c7061f00 53002-1305 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 RPK Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1306_52268cc1-9302-44f1-84dd-c31b67c62b61 53002-1306 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960918 ANDA ANDA074569 RPK Pharmaceuticals, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 53002-1320_9476c50d-163c-47d4-85f7-76c782518723 53002-1320 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20080320 ANDA ANDA077689 RPK Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 53002-1324_2526af53-727b-43fb-bfab-b6ee86367456 53002-1324 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20080701 ANDA ANDA076407 RPK Pharmaceuticals, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 53002-1335_357ae283-89bb-4d44-8222-c0627daa74cb 53002-1335 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 RPK Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53002-1345_a02dedfd-b5ca-455b-bb46-60663b114642 53002-1345 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090324 ANDA ANDA079095 RPK Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 53002-1350_c8696791-7a7f-41f2-a53b-911ecff9612b 53002-1350 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150109 ANDA ANDA202801 RPK Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 53002-1351_013a8447-b5df-454b-a392-9e749c62bb26 53002-1351 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 RPK Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 53002-1352_013a8447-b5df-454b-a392-9e749c62bb26 53002-1352 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 RPK Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 53002-1359_64e91ecc-9494-45cc-afe7-0b5208ab2ff1 53002-1359 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 RPK Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1360_64e91ecc-9494-45cc-afe7-0b5208ab2ff1 53002-1360 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 RPK Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1361_991fde7f-dd03-42cc-badd-d499b3454ab2 53002-1361 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 RPK Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1365_991fde7f-dd03-42cc-badd-d499b3454ab2 53002-1365 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 RPK Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1366_991fde7f-dd03-42cc-badd-d499b3454ab2 53002-1366 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 RPK Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1385_d6561c2c-96b5-4447-a934-f6d65186639a 53002-1385 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 RPK Pharmaceuticals, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53002-1387_2e7e70b3-86e5-439d-8dea-a7806d6fcace 53002-1387 HUMAN PRESCRIPTION DRUG OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE ORAL 20170224 ANDA ANDA208578 RPK Pharmaceuticals, Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 53002-1419_129c7b6a-401b-4b8a-a32b-d3cc332b78ce 53002-1419 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 RPK Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 53002-1422_4ca8741f-24a7-4e31-94da-027adb8f9708 53002-1422 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 RPK Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 53002-1423_5d6bd69c-3c85-4cd2-b18d-712580d43454 53002-1423 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 RPK Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53002-1436_84adf5d4-146b-4ac9-8c53-3d4245aaed78 53002-1436 HUMAN PRESCRIPTION DRUG QVAR Beclomethasone Dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20140915 NDA NDA020911 RPK Pharmaceuticals, Inc. BECLOMETHASONE DIPROPIONATE 40 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 53002-1438_2dd6e292-a5d7-4dea-a946-b139508b5644 53002-1438 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130319 ANDA ANDA202389 RPK Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1439_357ae283-89bb-4d44-8222-c0627daa74cb 53002-1439 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 RPK Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53002-1440_357ae283-89bb-4d44-8222-c0627daa74cb 53002-1440 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 RPK Pharmaceuticals, Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53002-1441_40bb211c-e121-4a0a-b7be-9236a42336f3 53002-1441 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20130411 ANDA ANDA202717 RPK Pharmaceuticals, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 53002-1445_4ca8741f-24a7-4e31-94da-027adb8f9708 53002-1445 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 RPK Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 53002-1451_52268cc1-9302-44f1-84dd-c31b67c62b61 53002-1451 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960917 ANDA ANDA074569 RPK Pharmaceuticals, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 53002-1453_2dd6e292-a5d7-4dea-a946-b139508b5644 53002-1453 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130321 ANDA ANDA202389 RPK Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1463_4ec6618e-4aa9-4577-8552-141fa7de5456 53002-1463 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 RPK Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53002-1472_5d6bd69c-3c85-4cd2-b18d-712580d43454 53002-1472 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 RPK Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53002-1477_84adf5d4-146b-4ac9-8c53-3d4245aaed78 53002-1477 HUMAN PRESCRIPTION DRUG QVAR Beclomethasone Dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20140915 NDA NDA020911 RPK Pharmaceuticals, Inc. BECLOMETHASONE DIPROPIONATE 80 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 53002-1494_f8393ece-56d2-4b2b-a08d-502eb035d7b1 53002-1494 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20170316 ANDA ANDA208706 RPK Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1501_6fc2c200-a497-45b2-8e7c-25f4e774db57 53002-1501 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20061212 ANDA ANDA040621 RPK Pharmaceuticals, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 53002-1507_2835a131-16b5-48f2-ba11-ba64e3fdd9ce 53002-1507 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 RPK Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1550_e4e75d0b-1f83-4ef4-a952-d0bbb8fe5e3d 53002-1550 HUMAN PRESCRIPTION DRUG PROAIR HFA Albuterol Sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20121203 NDA NDA021457 RPK Pharmaceuticals, Inc. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 53002-1561_f8393ece-56d2-4b2b-a08d-502eb035d7b1 53002-1561 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20170316 ANDA ANDA208706 RPK Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1562_0668f983-bc63-40d6-9b8e-b83d63eace4d 53002-1562 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 RPK Pharmaceuticals, Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 53002-1579_fdfa2b23-c061-4f3e-82f3-60294a151481 53002-1579 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 RPK Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53002-1584_4bf6d435-0e0e-46b4-b0b9-24b3c74dad42 53002-1584 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 RPK Pharmaceuticals, Inc. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 53002-1604_675c14c7-2261-4dd0-963c-00f53c37ad48 53002-1604 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20080317 ANDA ANDA076128 RPK Pharmaceuticals, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 53002-1623_bd992535-16b1-44fc-87a0-0d0db7e4e751 53002-1623 HUMAN PRESCRIPTION DRUG CHLORTHALIDONE CHLORTHALIDONE TABLET ORAL 20170517 ANDA ANDA206904 RPK Pharmaceuticals, Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 53002-1624_0edf57a6-c92c-4b5a-96d8-4dded4126a3c 53002-1624 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 RPK Pharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 53002-1638_3fbb620b-0d7b-4235-8c69-1db3dc91bca1 53002-1638 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 RPK Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 53002-1643_3fbb620b-0d7b-4235-8c69-1db3dc91bca1 53002-1643 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 RPK Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 53002-1671_790101b8-9845-428f-847d-54dee95863b4 53002-1671 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20150316 ANDA ANDA204597 RPK Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 53002-1687_19ac3421-1296-4bf7-afea-de4771da9bb4 53002-1687 HUMAN PRESCRIPTION DRUG LYZA norethindrone TABLET ORAL 20130624 ANDA ANDA200980 RPK Pharmaceuticals, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20191231 53002-2080_c5ea7905-7488-49c3-9ade-678c992546a4 53002-2080 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 RPK Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 53002-2100_703cd04f-ad1a-43ca-b032-9ca19d7d7054 53002-2100 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 RPK Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 53002-2221_0eeb437e-d05a-489d-9b82-6fd264b53eee 53002-2221 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110718 ANDA ANDA065509 RPK Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 53002-2224_3224fcda-0a54-40ee-92e5-03d9e948d453 53002-2224 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 RPK Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 53002-2228_a3e3b58e-c4d8-4a10-bad3-e5d84ac6a5fa 53002-2228 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 RPK Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 53002-2470_aba97490-3e0b-4489-9025-c936bbc93b42 53002-2470 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 RPK Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20191231 53002-2478_0435bdb0-dc60-446d-8a22-32082b317ed7 53002-2478 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 RPK Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20191231 53002-2640_7ecd008a-2b5d-4a02-aa07-5acf69b511b9 53002-2640 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 RPK Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 53002-2710_ba262dd4-297d-4dbc-a764-6e3261cc4f0b 53002-2710 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 RPK Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20191231 53002-2790_7ecd008a-2b5d-4a02-aa07-5acf69b511b9 53002-2790 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 RPK Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 53002-3080_db57b385-9445-451d-badb-155901f5f881 53002-3080 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 RPK Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 53002-3090_30e06977-2066-4642-bb52-6533b944b4fa 53002-3090 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 RPK Pharmaceuticals, Inc. PREDNISONE 10 mg/1 N 20191231 53002-3110_b146731f-f38b-464c-8db8-a1ced4a57bd6 53002-3110 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20160706 ANDA ANDA091416 RPK Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 53002-3190_8c7a499c-82d9-4fe5-9118-30f738524c4c 53002-3190 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 19960901 OTC MONOGRAPH FINAL part341 RPK Pharmaceuticals, Inc. CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV N 20191231 53002-3250_30e06977-2066-4642-bb52-6533b944b4fa 53002-3250 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 RPK Pharmaceuticals, Inc. PREDNISONE 20 mg/1 N 20191231 53002-3270_d7cfc0b2-e1e2-4329-9956-b7f4f2074413 53002-3270 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SOLUTION ORAL 20060131 ANDA ANDA040650 RPK Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20191231 53002-3340_3d24a9be-6de8-4b52-ab3c-dc309be11a6e 53002-3340 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071321 RPK Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 53002-3370_40ff6c9d-1764-44a9-a2fe-b170ab4f6d23 53002-3370 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 RPK Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 53002-4180_13869d3c-7bba-49cb-9953-c92d798884f5 53002-4180 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 RPK Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 53002-4300_643aaf50-bb72-4f32-8b13-bf377d5be177 53002-4300 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 RPK Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 53002-4320_103e7ac2-9001-42db-ac11-5a18dee78edb 53002-4320 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 RPK Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20191231 53002-4460_576a350e-7f24-4819-a3e4-ed766ab0238a 53002-4460 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 RPK Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 53002-4970_f7f70ad2-376a-4b15-80f8-a2374ed70bb1 53002-4970 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 RPK Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 53002-5020_86c674ec-95af-423e-be68-aa71d1ed34d9 53002-5020 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 RPK Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20191231 53002-5290_43442c0f-6774-464a-901c-a6be945ca902 53002-5290 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 RPK Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 53002-5520_8979f9cc-4254-4477-9fcf-75eb8512d59d 53002-5520 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 RPK Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 53002-7040_73d1c317-9e59-4c13-be62-2e99c9699472 53002-7040 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 RPK Pharmaceuticals, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20191231 53002-7041_0567ee75-6921-4d2b-b671-f0f21bda0f31 53002-7041 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 20050406 ANDA ANDA077066 RPK Pharmaceuticals, Inc. NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20191231 53002-7690_75086998-a7a2-4687-ad82-007bc9519d9c 53002-7690 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20080116 ANDA ANDA077570 RPK Pharmaceuticals, Inc. FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 53002-7720_ca059da1-55e7-4ea1-857b-1fd483b7dd4e 53002-7720 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061227 ANDA ANDA077657 RPK Pharmaceuticals, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 53002-7890_264aca0f-2fed-4199-9d68-d079aa64c73b 53002-7890 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 RPK Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 53002-7891_b6a8f4f8-b9fa-4ac0-a735-1866f5a073cb 53002-7891 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021121 ANDA ANDA065093 RPK Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 53002-7898_8bb5d37e-c796-4966-a143-ef2de8206ba3 53002-7898 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021121 ANDA ANDA065093 RPK Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 53002-7930_c94fe6fc-0559-4a97-8e28-4e34cd55d307 53002-7930 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20050415 ANDA ANDA040555 RPK Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20191231 53002-8620_08243f1b-d240-4c19-9123-6e39352c7557 53002-8620 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 19970214 ANDA ANDA064120 RPK Pharmaceuticals, Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 53002-9000_b754d103-5f2a-4efc-bf04-02d1ac2d5d85 53002-9000 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 RPK Pharmaceuticals, Inc. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20191231 53002-9050_cf6c30ea-79fa-4fa0-9de9-141c658972a3 53002-9050 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 RPK Pharmaceuticals, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 53002-9060_4565c35a-7d9d-49a3-bda7-31b355d6d4b1 53002-9060 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SOLUTION AURICULAR (OTIC) 20030318 ANDA ANDA062423 RPK Pharmaceuticals, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [iU]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 53002-9090_9d3adbe8-dd33-43a3-b46a-191950bf50a9 53002-9090 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 RPK Pharmaceuticals, Inc. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 53002-9120_425cb167-fdab-47d8-85a2-675e47cfdac2 53002-9120 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20150910 ANDA ANDA089796 RPK Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 53002-9230_d12a6385-86c5-4ade-9ce1-1cc1d1d3f048 53002-9230 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19931129 ANDA ANDA064052 RPK Pharmaceuticals, Inc. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 53002-9231_12d70518-ee66-4627-87e1-2c40cfb2763a 53002-9231 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064096 RPK Pharmaceuticals, Inc. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 53002-9290_7391064d-7476-4d8d-aa3d-c60e6f273fef 53002-9290 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20061213 ANDA ANDA064163 RPK Pharmaceuticals, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 53002-9330_b776531a-ab61-42b0-b341-0e13cd183f9c 53002-9330 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20060928 ANDA ANDA086414 RPK Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 53002-9331_7f5319f7-30e8-4134-9f0e-76ab449ae36e 53002-9331 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20150414 ANDA ANDA089798 RPK Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 53002-9660_2dea3ace-36de-45c0-a7de-c004ce8b9d35 53002-9660 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20020930 ANDA ANDA089682 RPK Pharmaceuticals, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 53002-9661_380b1cd0-5404-4d13-86e3-73754c20c5ec 53002-9661 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20060331 ANDA ANDA085025 RPK Pharmaceuticals, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 53002-9850_f8be221a-c4f5-475f-bacc-0192973b9668 53002-9850 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20110608 ANDA ANDA090480 RPK Pharmaceuticals, Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20191231 53009-1001_3eb0940e-e197-43cc-bc9a-7d01dcf61dd1 53009-1001 HUMAN OTC DRUG MIOGGI Healing Effector RX Collagenic ADENOSINE CREAM TOPICAL 20120820 UNAPPROVED DRUG OTHER Colorpink R&D Inc. ADENOSINE .02 mg/50mL E 20171231 53009-2001_2c6f47a0-36a3-4fd0-a303-d409f91031e0 53009-2001 HUMAN OTC DRUG MIOGGI Magic Advanced Skin Essential Activator ADENOSINE LIQUID TOPICAL 20120820 UNAPPROVED DRUG OTHER Colorpink R&D Inc. ADENOSINE .05 mg/125mL E 20171231 53010-1001_39cf1622-867f-49b6-a7e3-4bbb4b2d65b2 53010-1001 HUMAN OTC DRUG JNH Dr. Intensive Plus UV Protector TITANIUM DIOXIDE CREAM TOPICAL 20120824 UNAPPROVED DRUG OTHER Daeduck Lab Co., Ltd TITANIUM DIOXIDE 1.5 g/50g E 20171231 53010-2001_0e59f98d-b9f0-40f8-bebf-fb07d759ce75 53010-2001 HUMAN OTC DRUG JNH Magic BB SIMMONDSIA CHINENSIS SEED CREAM TOPICAL 20120824 UNAPPROVED DRUG OTHER Daeduck Lab Co., Ltd SIMMONDSIA CHINENSIS SEED .9 g/30g E 20171231 53010-3001_4c7b2fdb-3890-443e-a3cf-5eac1e2d0266 53010-3001 HUMAN OTC DRUG JNH Ato-Care Super Barried ATO-Serum CERAMIDE 3 LIQUID TOPICAL 20120824 UNAPPROVED DRUG OTHER Daeduck Lab Co., Ltd CERAMIDE 3 1.5 mg/50mL E 20171231 53010-4001_061f3424-9b50-4e27-9a7e-657d6fdfa55f 53010-4001 HUMAN OTC DRUG JNH a-Clear Resurface Sulfur GLYCERIN GEL TOPICAL 20141015 OTC MONOGRAPH FINAL part347 Daeduck Lab Co., Ltd. GLYCERIN 2 g/100g E 20171231 53010-5001_053f57e6-b21d-471d-91c8-727b4dde0575 53010-5001 HUMAN OTC DRUG JNH a-Clear Propolis Spot Serum GLYCERIN LIQUID TOPICAL 20141015 OTC MONOGRAPH FINAL part347 Daeduck Lab Co., Ltd. GLYCERIN 2 g/100mL E 20171231 53014-530_cbb7eb03-57e6-4a38-8d1b-110236208ede 53014-530 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19771223 ANDA ANDA085799 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 53014-531_cbb7eb03-57e6-4a38-8d1b-110236208ede 53014-531 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19790404 ANDA ANDA086429 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 53014-532_cbb7eb03-57e6-4a38-8d1b-110236208ede 53014-532 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19790404 ANDA ANDA086428 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 53014-548_0503c2c1-238b-4189-9b9c-08e712fa9313 53014-548 HUMAN PRESCRIPTION DRUG Tussionex Pennkinetic hydrocodone polistirex and chlorpheniramine polistirex SUSPENSION, EXTENDED RELEASE ORAL 19871231 NDA NDA019111 Unither Manufacturing LLC HYDROCODONE; CHLORPHENIRAMINE 10; 8 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII N 20181231 53014-579_bb9a02a4-3803-482d-970d-0f27f3b6f452 53014-579 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030812 NDA NDA021259 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 53014-580_bb9a02a4-3803-482d-970d-0f27f3b6f452 53014-580 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030218 NDA NDA021259 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 53014-581_bb9a02a4-3803-482d-970d-0f27f3b6f452 53014-581 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030722 NDA NDA021259 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 53014-582_bb9a02a4-3803-482d-970d-0f27f3b6f452 53014-582 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA NDA021259 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 53014-583_bb9a02a4-3803-482d-970d-0f27f3b6f452 53014-583 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA NDA021259 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 53014-584_bb9a02a4-3803-482d-970d-0f27f3b6f452 53014-584 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA NDA021259 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 53014-594_6470b9ad-04b8-4386-b2c3-184518ac6957 53014-594 HUMAN PRESCRIPTION DRUG Metadate ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 19880601 ANDA ANDA089601 Unither Manufacturing, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 53017-801_308cc173-b808-453a-986e-e103e1085370 53017-801 HUMAN OTC DRUG Branders Antiseptic Hand Sanitizer ETHYL ALCOHOL SPRAY TOPICAL 20120718 OTC MONOGRAPH NOT FINAL part333E BRANDERS.COM, INC. ALCOHOL 62 mL/100mL N 20181231 53017-802_18437382-0d51-4cc3-97d0-bb6a00ed7700 53017-802 HUMAN OTC DRUG Branders Antiseptic Hand Sanitizer ETHYL ALCOHOL SPRAY TOPICAL 20120718 OTC MONOGRAPH NOT FINAL part333E BRANDERS.COM, INC. ALCOHOL 62 mL/100mL N 20181231 53028-1001_81b999e3-a6b9-4c8d-b26e-fbeab7bee7ab 53028-1001 HUMAN OTC DRUG Armarita Sulfur LIQUID VAGINAL 20120802 OTC MONOGRAPH FINAL part333D JG Select Inc SULFUR .12 mg/3mL E 20171231 53033-001_752587cb-6a25-4404-aad9-66269dbe1052 53033-001 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20120824 OTC MONOGRAPH FINAL part333A Pioneer Associates ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 53033-002_140428ad-3067-4cd4-a460-01f55aa0c683 53033-002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol with Wintergreen Oil Isopropyl Alcohol LIQUID TOPICAL 20120824 OTC MONOGRAPH FINAL part333A Pioneer Associates ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 53033-003_001adbf8-50c8-44e1-9c78-4993c42c27b1 53033-003 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20120824 OTC MONOGRAPH NOT FINAL part333A Pioneer Associates HYDROGEN PEROXIDE 3 mL/100mL N 20181231 53033-004_5784d32a-bb75-44c3-a350-3b84904e7777 53033-004 HUMAN OTC DRUG CAVALIER Fresh Scent Petrolatum OINTMENT TOPICAL 20121031 OTC MONOGRAPH FINAL part347 Imperial Bag & Paper Co.,LLC dba Pioneer Associates PETROLATUM 99.9 g/100g E 20171231 53033-005_6b46d8ac-6e3d-4b2e-be1b-8d164858bb00 53033-005 HUMAN OTC DRUG CAVALIER Petrolatum OINTMENT TOPICAL 20121031 OTC MONOGRAPH FINAL part347 Imperial Bag & Paper Co.,LLC dba Pioneer Associates PETROLATUM 99.9 g/100g E 20171231 53033-006_1a4b1b2d-9a15-4818-a2d3-2bd974c3b142 53033-006 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20130205 OTC MONOGRAPH NOT FINAL part333A Pioneer Associates ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 53033-007_5879b3dc-779f-4cfe-93ab-1a8a80eaffd2 53033-007 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN OIL Isopropyl Alcohol LIQUID TOPICAL 20130205 OTC MONOGRAPH NOT FINAL part333A Pioneer Associates ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 53038-001_60dd79e5-994a-d1d3-e053-2a91aa0a1bc0 53038-001 HUMAN OTC DRUG Friccilicont Menthol, Methyl Salicylate CREAM TOPICAL 20120815 OTC MONOGRAPH NOT FINAL part348 Labocont Industrial MENTHOL; METHYL SALICYLATE 3; 10 g/100g; g/100g N 20181231 53040-993_95630b62-2ac7-46b2-ba5b-6367e6a18120 53040-993 HUMAN OTC DRUG The Fresh Market Hand Sanitizer With Moisturizers Aloe And Vitamin E ALCOHOL GEL TOPICAL 20120802 OTC MONOGRAPH FINAL part333E The Fresh Market ALCOHOL 65 mL/100mL N 20181231 53040-994_b355d08b-5225-4d92-81eb-70800df51870 53040-994 HUMAN OTC DRUG The Fresh Market Hand Sanitizer Alcohol Free BENZALKONIUM CHLORIDE GEL TOPICAL 20120802 OTC MONOGRAPH FINAL part333E The Fresh Market BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 53040-995_24d8d5a2-7b65-40a7-9864-b80896444b20 53040-995 HUMAN OTC DRUG The Fresh Market SPF 15 Lip Balm Broad Spectrum Acai Berry AVOBENZONE, OCTINOXATE, OXYBENZONE STICK TOPICAL 20120802 OTC MONOGRAPH FINAL part352 The Fresh Market AVOBENZONE; OCTINOXATE; OXYBENZONE 2; 7.5; 3.5 g/100g; g/100g; g/100g N 20181231 53040-996_0f842c68-0ace-4165-aa76-07e71343a423 53040-996 HUMAN OTC DRUG The Fresh Market Medicated Lip Balm Soothing With Menthol Eucalyptus Oil And Clove MENTHOL STICK TOPICAL 20120802 OTC MONOGRAPH FINAL part348 The Fresh Market MENTHOL .6 g/100g N 20181231 53041-126_7403d7c5-721a-43df-8b84-a3168cdabf2d 53041-126 HUMAN OTC DRUG Alkums antacid calcium carbonate TABLET, CHEWABLE ORAL 20120201 OTC MONOGRAPH FINAL part331 Guardian Drug Company CALCIUM CARBONATE 500 mg/1 N 20181231 53041-127_8f6abfcb-f6b0-4835-9f4d-a97175c159ac 53041-127 HUMAN OTC DRUG Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20120202 OTC MONOGRAPH FINAL part331 Guardian Drug Company CALCIUM CARBONATE 750 1/1 N 20181231 53041-128_87b18d62-d760-46b7-a5b5-331ef7defcba 53041-128 HUMAN OTC DRUG Foamcoat Antacid Aluminum hydroxide, Magnesium carbonate TABLET, CHEWABLE ORAL 20050404 OTC MONOGRAPH FINAL part331 Guardian Drug Company ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 N 20181231 53041-147_a144fbe3-7130-4cb4-9c22-b5c3e8fb94cb 53041-147 HUMAN OTC DRUG Fiber Caps Calcium polycarbophil TABLET, FILM COATED ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 Guardian Drug Company CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 53041-152_4961737d-229c-4289-836e-5165220f8821 53041-152 HUMAN OTC DRUG Alumox Aluminum Hydroxide, Magnesium Hydroxide, Simethicone TABLET, CHEWABLE ORAL 20040606 OTC MONOGRAPH FINAL part331 Guardian Drug Company ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 25 mg/1; mg/1; mg/1 N 20181231 53041-159_c4045bad-c868-4d8d-ab83-f26fbdb1aac2 53041-159 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 20020202 OTC MONOGRAPH NOT FINAL part334 Guardian Drug Company SENNOSIDES 8.6 mg/1 N 20181231 53041-401_3c4af140-a8d1-4085-9343-92c5bea6c3da 53041-401 HUMAN OTC DRUG Natural Fiber Psyllium husk POWDER, FOR SUSPENSION ORAL 20030101 OTC MONOGRAPH NOT FINAL part334 GUARDIAN DRUG COMPANY PSYLLIUM HUSK 3.4 g/7g N 20181231 53041-402_8c2bf44f-be7c-4e3b-ba4b-d758b04d3976 53041-402 HUMAN OTC DRUG Original Texture, Orange Flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20030101 OTC MONOGRAPH NOT FINAL part334 Guardian Drug Company PSYLLIUM HUSK 3.4 g/11g N 20181231 53041-403_ffb94e19-4002-43c7-8374-de5517ab6600 53041-403 HUMAN OTC DRUG Smooth texture Orange flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20030101 OTC MONOGRAPH NOT FINAL part334 Guardian PSYLLIUM HUSK 3.4 g/12g N 20181231 53041-405_1787aec2-b365-4d67-80a6-fc0fe1f781d1 53041-405 HUMAN OTC DRUG Guardian psyllium husk POWDER, FOR SUSPENSION ORAL 20010101 OTC MONOGRAPH NOT FINAL part334 Guardian PSYLLIUM HUSK 3.4 g/5.8g N 20181231 53041-412_44954519-b178-45df-aeb3-44e0a331cef5 53041-412 HUMAN OTC DRUG Sugar Free Smooth Texture, Berry Flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20120101 OTC MONOGRAPH NOT FINAL part334 Guardian Drug Company PSYLLIUM HUSK 3.4 g/5.8g N 20181231 53041-527_fdb49e2e-e093-4fbc-9c8d-3e7b632710c2 53041-527 HUMAN OTC DRUG Pink-Bismuth Bismuth Subsalicylate LIQUID ORAL 20080530 OTC MONOGRAPH FINAL part335 Guardian Drug Company BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 53041-577_43b4f37f-5ec3-4888-8174-011414db2ea3 53041-577 HUMAN OTC DRUG Childrens Metapp Daytime Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20120606 OTC MONOGRAPH FINAL part341 Guardian Drug Company BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 53041-615_7f5007ce-e8df-4be8-a965-236341719bdc 53041-615 HUMAN OTC DRUG Childrens Tussnex Multi-symptom cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Guardian Drug Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 53041-616_1d066711-15e9-4fc2-a241-79fcfd6d2741 53041-616 HUMAN OTC DRUG Tussnex FM Cold and Sinus Acteaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Guardian Drug Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 53041-617_ca149b66-2e20-42e9-bb68-49e4bcd0c23f 53041-617 HUMAN OTC DRUG Tussnex FM Severe cough and congestion Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Guardian Drug Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 53041-618_290cc80d-c9d8-4f26-80eb-c289c6cb9272 53041-618 HUMAN OTC DRUG Tussnex FM Cold, Flu and Sore Throat Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Guardian Drug Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 53041-622_3a42dca8-725c-44a6-bcac-4c4da8c47446 53041-622 HUMAN OTC DRUG Childrens Tussnex Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20120505 OTC MONOGRAPH FINAL part341 Guardian Drug Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN 325; 10; 5; 200 mg/10mL; mg/10mL; mg/10mL; mg/10mL N 20181231 53041-628_fbaba20c-3fd0-4277-b00c-8f0d0312bcec 53041-628 HUMAN OTC DRUG Maximum strength Tussnex FM DM Max Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20120501 OTC MONOGRAPH FINAL part341 Guardian Drug Company DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 53041-650_c6047f86-9687-4c3c-b70e-71d65b526e29 53041-650 HUMAN OTC DRUG Natural Fiber Psyllium Husk CAPSULE ORAL 20030101 OTC MONOGRAPH NOT FINAL part334 Guardian Drug Company PSYLLIUM HUSK .52 g/1 N 20181231 53043-001_56d787bf-d7c2-463b-aac7-b00dcfdb2230 53043-001 HUMAN OTC DRUG Pain ReliefPatches Patches DL-Camphor L-Menthol Methyl Salicylate PATCH TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Shanghai Aquagel Bio-Plymer Co., Ltd CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 1.2; 4; 6.3 mL/100mL; mL/100mL; mL/100mL E 20171231 53043-003_8dccfbae-5bf0-4c02-8c03-da491358efa7 53043-003 HUMAN OTC DRUG Mini Pain Relief DL-Camphor L-Menthol Methyl Salicylate PATCH TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 Shanghai Aquagel Bio-Plymer Co., Ltd CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 1.2; 2.7; 2.5 mg/1; mg/1; mg/1 E 20171231 53045-100_f5e4326e-617a-430c-bd41-f3602cc3fd08 53045-100 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g N 20181231 53045-101_fbef86e1-96fa-41b5-bf4a-a944ddc64355 53045-101 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g N 20181231 53045-102_4320cd62-0107-4aec-9ec1-ab24e87fa181 53045-102 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g N 20181231 53045-103_045a70a9-e15b-4b7c-bc16-ceac8b4018cb 53045-103 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g N 20181231 53045-104_ca47b255-9f1b-4850-80c5-d8e10c154a6e 53045-104 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g N 20181231 53045-105_f0f5891f-8538-4838-a82f-48c12cafcdb2 53045-105 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g N 20181231 53045-106_84ff0f16-188d-4e79-bac0-268a973d2e74 53045-106 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g N 20181231 53045-107_77633a8a-bc4a-4b7d-bf4e-0139d349ebf3 53045-107 HUMAN OTC DRUG Opahl Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g N 20181231 53045-112_2a5c883b-8eea-4a9c-8a64-341f313e8a2f 53045-112 HUMAN OTC DRUG Opahl Dye Free Benzocaine GEL DENTAL; ORAL 20131102 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/32g N 20181231 53045-125_c2ad7bd9-78c9-40d9-9d3f-8e3c56de6036 53045-125 HUMAN PRESCRIPTION DRUG Opahl Benzocaine SPRAY, METERED DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. BENZOCAINE 12 g/60g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 53045-130_5d87d5bf-0647-45aa-9781-7e7d8fc0de06 53045-130 HUMAN OTC DRUG Iolite Benzocaine GEL DENTAL; ORAL 20170717 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/100g N 20181231 53045-131_d1559689-251b-4ed2-91e7-e3603068e71f 53045-131 HUMAN OTC DRUG Iolite Benzocaine GEL DENTAL; ORAL 20170719 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/100g N 20181231 53045-132_bc76b5c7-e049-484d-8cbc-d694fc274114 53045-132 HUMAN OTC DRUG Iolite Benzocaine GEL DENTAL; ORAL 20170719 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/100g N 20181231 53045-133_1eb14d3a-f407-4317-a5c9-d23f6f2fd2c1 53045-133 HUMAN OTC DRUG Iolite Benzocaine GEL DENTAL; ORAL 20170719 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/100g N 20181231 53045-134_b8c0427a-4978-491e-8a08-89d6bda4c371 53045-134 HUMAN OTC DRUG Iolite Benzocaine GEL DENTAL; ORAL 20170720 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/100g N 20181231 53045-135_a70ab992-8c43-4cfb-91d8-49b513cb06b7 53045-135 HUMAN OTC DRUG Iolite Benzocaine GEL DENTAL; ORAL 20170723 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/100g N 20181231 53045-136_f5d46729-60f4-4b4f-9c26-e2496d55f363 53045-136 HUMAN OTC DRUG Iolite Benzocaine GEL DENTAL; ORAL 20170723 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/100g N 20181231 53045-137_5650468c-3272-41b1-898b-702cc93d24c3 53045-137 HUMAN OTC DRUG Ioline Benzocaine GEL DENTAL; ORAL 20170723 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/100g N 20181231 53045-138_70dd8113-8d6c-4650-b3af-091b13d06f63 53045-138 HUMAN OTC DRUG Iolite Benzocaine GEL DENTAL; ORAL 20170723 OTC MONOGRAPH NOT FINAL part356 Dharma Research, Inc. BENZOCAINE 6.4 g/100g N 20181231 53045-200_e00740db-2621-42f7-973d-aefb79199b32 53045-200 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 10.241 g/490g N 20181231 53045-201_f7ce2c5f-a151-4f1e-87e5-1ad161cbda53 53045-201 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 10.241 g/490g N 20181231 53045-202_7bdc5337-13b7-411d-aee1-580c72d53430 53045-202 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 6.027 g/490g N 20181231 53045-203_dba99f17-55e9-4bf7-964f-f7476ea450cb 53045-203 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 6.027 g/490g N 20181231 53045-204_2ca7c53d-6021-49a1-99a4-a244f198f218 53045-204 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 6.027 g/490g N 20181231 53045-205_16feddba-f871-4445-a788-904bafb375be 53045-205 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 6.027 g/490g N 20181231 53045-206_e21e9d7a-4abd-4831-9268-5de2ed7212bc 53045-206 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 6.027 g/490g N 20181231 53045-207_a662954e-0102-419f-add4-e05b4f865e36 53045-207 HUMAN PRESCRIPTION DRUG Ionite APF Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 6.027 g/490g N 20181231 53045-235_062028c9-c82d-49d7-b0ef-27cb99d69e7f 53045-235 HUMAN PRESCRIPTION DRUG Ionite APF Neutral Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 4.41 g/490g N 20181231 53045-237_48d0d960-21a1-4f26-8814-c54f93657458 53045-237 HUMAN PRESCRIPTION DRUG Ionite APF Neutral Sodium Fluoride GEL DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 4.41 g/490g E 20171231 53045-250_b10324c7-9eec-4c91-8961-77f992c3d9c9 53045-250 HUMAN PRESCRIPTION DRUG Ionite APF Foam Sodium Fluoride AEROSOL, FOAM DENTAL; ORAL; TOPICAL 20130422 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 1.5498 g/126g N 20181231 53045-251_f3d95782-692c-4e95-8860-5d3eb83f9fb3 53045-251 HUMAN PRESCRIPTION DRUG Ionite APF Foam Sodium Fluoride AEROSOL, FOAM DENTAL; ORAL; TOPICAL 20130422 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 1.5498 g/126g N 20181231 53045-252_3f553fd8-38b6-4bf8-b816-cb6085a61866 53045-252 HUMAN PRESCRIPTION DRUG Ionite APF Foam Sodium Fluoride AEROSOL, FOAM DENTAL; ORAL; TOPICAL 20130422 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 1.5498 g/126g N 20181231 53045-253_50ebddb4-1050-4c81-bba3-803182f83490 53045-253 HUMAN PRESCRIPTION DRUG Ionite APF Foam Sodium Fluoride AEROSOL, FOAM DENTAL; ORAL; TOPICAL 20130422 UNAPPROVED DRUG OTHER Dharma Research, inc. SODIUM FLUORIDE 1.5498 g/126g N 20181231 53045-265_892f5bdc-eabb-4942-925e-93164f9fc826 53045-265 HUMAN PRESCRIPTION DRUG Ionite R Sodium Fluoride LIQUID DENTAL; ORAL 20131103 UNAPPROVED DRUG OTHER Dharma Research, Inc. SODIUM FLUORIDE 38 g/L N 20181231 53045-266_76cc9393-6ce4-405e-a58f-25a630c64586 53045-266 HUMAN PRESCRIPTION DRUG Ionite R Sodium Fluoride LIQUID DENTAL; ORAL 20131103 UNAPPROVED DRUG OTHER Dharma Research, Inc. SODIUM FLUORIDE 38 g/L N 20181231 53045-270_dc44c94f-a56c-48ba-86fc-2bfb3bba63c0 53045-270 HUMAN OTC DRUG Ionite H Stannous Fluoride GEL, DENTIFRICE DENTAL 20150802 OTC MONOGRAPH FINAL part355 Dharma Research, Inc. STANNOUS FLUORIDE .4 mg/100g N 20181231 53045-271_1f70f58a-266a-4d51-9895-9ac70f8425ec 53045-271 HUMAN OTC DRUG Ionite H Stannous Fluoride GEL, DENTIFRICE DENTAL 20150802 OTC MONOGRAPH FINAL part355 Dharma Research, Inc. STANNOUS FLUORIDE .4 mg/100g N 20181231 53045-275_bb9fa14d-082b-4773-8836-1c6736219ff2 53045-275 HUMAN OTC DRUG Ionite H Stannous Fluoride MOUTHWASH DENTAL 20150803 OTC MONOGRAPH FINAL part355 Dharma Research, Inc. STANNOUS FLUORIDE .63 mg/100mL N 20181231 53045-276_2808ea72-fb19-4243-a965-898bc318286a 53045-276 HUMAN OTC DRUG Ionite H Stannous Fluoride MOUTHWASH DENTAL 20150803 OTC MONOGRAPH FINAL part355 Dharma Research, Inc. STANNOUS FLUORIDE .63 mg/100mL N 20181231 53045-280_0b21c890-82f5-4e90-8aa1-1e06d631760e 53045-280 HUMAN PRESCRIPTION DRUG Ionite H Sodium Fluoride, Potassium Nitrate GEL, DENTIFRICE DENTAL 20150802 UNAPPROVED DRUG OTHER Dharma Research, Inc. SODIUM FLUORIDE; POTASSIUM NITRATE 1.1; 5 mg/100g; mg/100g N 20181231 53045-281_ab938727-9383-48ce-a7a6-ed39d7d3ef15 53045-281 HUMAN PRESCRIPTION DRUG Ionite H Sodium Fluoride, Potassium Nitrate GEL, DENTIFRICE DENTAL 20150802 UNAPPROVED DRUG OTHER Dharma Research, Inc. SODIUM FLUORIDE; POTASSIUM NITRATE 1.1; 5 mg/100g; mg/100g E 20171231 53045-300_ee0790f9-cba0-410b-ab2d-928f73577f21 53045-300 HUMAN PRESCRIPTION DRUG Frenna AC Aluminum Chloride SOLUTION DENTAL; ORAL; TOPICAL 20130101 UNAPPROVED DRUG OTHER Dharma Research, inc. ALUMINUM CHLORIDE 8.75 g/35g N 20181231 53050-001_af46a613-3839-43b2-b4ba-c670ee4dd6e9 53050-001 HUMAN OTC DRUG Ora 2 stain clear SODIUM FLUORIDE PASTE DENTAL 20120822 OTC MONOGRAPH FINAL part355 Sunstar Guangzhou Ltd. SODIUM FLUORIDE .1 g/100g E 20171231 53050-002_4b537e5c-3680-17d3-e054-00144ff88e88 53050-002 HUMAN OTC DRUG G.U.M SODIUM FLUORIDE,CETYLPYRIDINIUM CHLORIDE PASTE DENTAL 20160710 OTC MONOGRAPH NOT FINAL part356 Sunstar Guangzhou Ltd. CETYLPYRIDINIUM CHLORIDE; SODIUM FLUORIDE .5; .21 g/100g; g/100g N 20181231 53057-001_29e8572d-eca8-48e2-bf33-c598ee7cb30b 53057-001 HUMAN OTC DRUG Holiday ElegancePeppermint Twist Peppermint Twist Peppermint Twist Triclosan LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Triz Laboratories Ltd. TRICLOSAN .9 g/300g E 20171231 53057-002_62ce880a-41e4-4249-9ab3-de171894e641 53057-002 HUMAN OTC DRUG Holiday EleganceFrosted Gingerbre Frosted Gingerbread Triclosan LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Triz Laboratories Ltd. TRICLOSAN .9 g/300g E 20171231 53057-003_6b62d2f9-8a73-491b-85e7-09ffcb26e684 53057-003 HUMAN OTC DRUG Holiday EleganceFrosted GingerbreFrosted Gingerbre Frosted Gingerbread Triclosan LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Triz Laboratories Ltd. TRICLOSAN .9 g/300g E 20171231 53057-004_831980c1-7a52-4738-b386-68347544775b 53057-004 HUMAN OTC DRUG Holiday Elegance Triclosan LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Triz Laboratories Ltd. TRICLOSAN .9 g/300g E 20171231 53057-005_2b4a0e0a-4267-45cc-a9b9-5d6294ef83e1 53057-005 HUMAN OTC DRUG Spatherapy ALCOHOL LOTION TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-006_8f31c072-3796-44bb-9a56-3bbb7b869aea 53057-006 HUMAN OTC DRUG Spatherapy ALCOHOL LOTION TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-007_44ea0d93-a9aa-4aa6-b27f-f3acbd82ade1 53057-007 HUMAN OTC DRUG Spatherapy ALCOHOL LOTION TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-008_2d837034-d369-40f2-a478-845742b7551e 53057-008 HUMAN OTC DRUG Spatherapy ALCOHOL LOTION TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-009_63e31e49-1e1b-4b9c-ad25-5218dc4ba21d 53057-009 HUMAN OTC DRUG Spatherapy ALCOHOL LOTION TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-010_80d0b06d-33dc-49e0-a3f0-d1d3228e0344 53057-010 HUMAN OTC DRUG Spatherapy ALCOHOL LOTION TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-012_418c2099-c2b5-4822-85f8-709a3ec36f0e 53057-012 HUMAN OTC DRUG Wilde Orchid ALCOHOL GEL TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-013_870271d8-75c8-4c55-922f-345ff0ba71b6 53057-013 HUMAN OTC DRUG Mojito Sun ALCOHOL GEL TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-014_89d25aeb-bf1e-4586-b9e3-206b34ca891c 53057-014 HUMAN OTC DRUG Hibiscus Breeze ALCOHOL GEL TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-015_2ad615c7-31f1-4a36-8020-bf5604c4e0bf 53057-015 HUMAN OTC DRUG Pineapple Paradise ALCOHOL GEL TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-016_4c331c73-4229-4168-9e23-22e57e507010 53057-016 HUMAN OTC DRUG Passion Fruit Kiss ALCOHOL GEL TOPICAL 20140513 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-017_6393c571-72ef-480e-b891-945ad1358ef5 53057-017 HUMAN OTC DRUG Coconut Tuberose ALCOHOL LOTION TOPICAL 20150218 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-018_2b91025c-8cb5-4e19-bfd5-4d7efcaf1be2 53057-018 HUMAN OTC DRUG Spatherapy Eucalyptus Mint ALCOHOL LOTION TOPICAL 20150218 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-019_2ee33f12-9597-4372-97c6-b2f1c1e38783 53057-019 HUMAN OTC DRUG Spatherapy Grapefruit Nectar ALCOHOL LOTION TOPICAL 20150218 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-020_8b04a11f-42fd-4842-bcb7-be9b0f24cd4e 53057-020 HUMAN OTC DRUG Spatherapy Lavender Jasmine ALCOHOL LOTION TOPICAL 20150218 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-021_80861b45-c136-4e7d-80dc-7de665ac0a6e 53057-021 HUMAN OTC DRUG Spatherapy Lemon Pomegranate ALCOHOL LOTION TOPICAL 20150218 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53057-022_49d31de8-6047-452d-9faa-eb3e3d3e443f 53057-022 HUMAN OTC DRUG Spatherapy Raspberry Brulee ALCOHOL LOTION TOPICAL 20150218 OTC MONOGRAPH NOT FINAL part333E TRIZ LABORATORIES LTD ALCOHOL 18 mL/30mL E 20171231 53063-1111_103a9da4-2804-4d50-8d0a-e909419e60ea 53063-1111 HUMAN OTC DRUG GO TIME Ammonia INHALANT RESPIRATORY (INHALATION) 20120813 UNAPPROVED DRUG OTHER Mountain Top Labs, LLC AMMONIA .013 mL/.3mL E 20171231 53063-1112_4baf36af-8252-4501-9ebb-a10ac9770cc6 53063-1112 HUMAN OTC DRUG GO TIME Ammonia INHALANT RESPIRATORY (INHALATION) 20120813 UNAPPROVED DRUG OTHER Mountain Top Labs, LLC AMMONIA .013 mL/.3mL E 20171231 53063-1113_ae3e24ae-ab8b-46af-a0db-1ba9a3802bc6 53063-1113 HUMAN OTC DRUG GO TIME Ammonia INHALANT RESPIRATORY (INHALATION) 20120813 UNAPPROVED DRUG OTHER Mountain Top Labs, LLC AMMONIA .013 mL/.3mL E 20171231 53063-1114_d743ad4a-55a4-4423-913c-2a79c0b29829 53063-1114 HUMAN OTC DRUG GO TIME Ammonia INHALANT RESPIRATORY (INHALATION) 20120813 UNAPPROVED DRUG OTHER Mountain Top Labs, LLC AMMONIA .013 mL/.3mL E 20171231 53077-1001_f0d5d34f-d6a8-4258-be05-a48de4d64200 53077-1001 HUMAN OTC DRUG Dr. Dream Advanced Facial Treatment Toner WITCH HAZEL LIQUID TOPICAL 20120824 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL E 20171231 53077-2001_6446c71b-fc50-435d-bb7d-a2c9747efa78 53077-2001 HUMAN OTC DRUG Dr. Dream Advanced Facial Treatment Serum WITCH HAZEL LIQUID TOPICAL 20120824 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL E 20171231 53077-3001_155a6e4e-66d3-482d-b87c-6f0f738849d0 53077-3001 HUMAN OTC DRUG Dr. Dream Advanced Facial Treatment Serum WITCH HAZEL CREAM TOPICAL 20120824 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL E 20171231 53077-4001_799beb8a-c90d-42c1-ae35-4005b4a661c1 53077-4001 HUMAN OTC DRUG Dr. Dream Advanced Eye Treatment WITCH HAZEL CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL E 20171231 53077-5001_2f12c08e-d3b3-48f5-96b1-84ec8c2b3550 53077-5001 HUMAN OTC DRUG Dr. Dream Cold Plazma Whitening WITCH HAZEL CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL E 20171231 53077-6001_397c9841-889b-4506-8484-68275df31a5f 53077-6001 HUMAN OTC DRUG Dr. Dream Hydramemory Deep active Moisturizer WITCH HAZEL CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL E 20171231 53077-7001_c4f3ef23-cc82-4b15-b096-476aecf63b7f 53077-7001 HUMAN OTC DRUG Dr. Dream Cold Plazma Whitening Serum WITCH HAZEL LIQUID TOPICAL 20120925 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL E 20171231 53077-8001_df111fe1-ee11-4eb7-92f0-dc85906e0995 53077-8001 HUMAN OTC DRUG Dr. Dream Urban Protective Advanced BB WITCH HAZEL CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL E 20171231 53077-9001_066ec298-4562-4b32-993c-9ddc7815a070 53077-9001 HUMAN OTC DRUG Dr. Dream Hydramemory Deep Cleansing WITCH HAZEL LIQUID TOPICAL 20120925 OTC MONOGRAPH FINAL part347 Dr. Dream Inc WITCH HAZEL .1 mg/100mL E 20171231 53078-010_28a56944-e063-4b9e-99d7-3247a63e2ccd 53078-010 HUMAN OTC DRUG DRH Intensive BB Titanium Dioxide CREAM TOPICAL 20161001 OTC MONOGRAPH NOT FINAL part352 NEW & NEW CO.,LTD. TITANIUM DIOXIDE 4.05 g/50g N 20181231 53078-020_627a4eae-d2d1-4ee2-acdd-5003b37f30b4 53078-020 HUMAN OTC DRUG DRH Intensive Sun Block Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide, Octocrylene CREAM TOPICAL 20161001 OTC MONOGRAPH NOT FINAL part352 NEW & NEW CO.,LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE; OCTOCRYLENE 3.75; 2.5; 2; 1.5; 1.5 g/50g; g/50g; g/50g; g/50g; g/50g N 20181231 53078-030_a3bc5ae0-c104-47b3-b391-7903cc85e566 53078-030 HUMAN OTC DRUG DRH Whitening G2 Serum Niacinamide CREAM TOPICAL 20161001 UNAPPROVED DRUG OTHER NEW & NEW CO.,LTD. NIACINAMIDE 1 g/50mL N 20181231 53078-040_b1f0e4cb-b6dd-423b-90d1-ee7906430d5d 53078-040 HUMAN OTC DRUG DRH Whitening G2 Arbutin, Adenosine CREAM TOPICAL 20161001 UNAPPROVED DRUG OTHER NEW & NEW CO.,LTD. ARBUTIN; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 53078-050_50922473-8fa8-4872-8d33-7c7592bbb34c 53078-050 HUMAN OTC DRUG DRH T STEM CELL Adenosine CREAM TOPICAL 20161001 UNAPPROVED DRUG OTHER NEW & NEW CO.,LTD. ADENOSINE .02 g/50g N 20181231 53078-060_7a38ec24-f60f-4791-bf7a-e3e8bec2286f 53078-060 HUMAN OTC DRUG DRH T STEM CELL Bio Cellulose Mask Witch Hazel PATCH TOPICAL 20161001 OTC MONOGRAPH FINAL part347 NEW & NEW CO.,LTD. WITCH HAZEL .025 g/25mL N 20181231 53078-070_02652cfe-f4df-4d5b-9cc9-d6c65e4726eb 53078-070 HUMAN OTC DRUG DRH T STEM CELL Adenosine LIQUID TOPICAL 20161001 UNAPPROVED DRUG OTHER NEW & NEW CO.,LTD. ADENOSINE 2 mg/5mL N 20181231 53078-080_45efb2d6-0eda-4da6-aa1f-2d8255918e6d 53078-080 HUMAN OTC DRUG DRH Ultimate Aqua Moisture Dimethicone CREAM TOPICAL 20161001 OTC MONOGRAPH FINAL part347 NEW & NEW CO.,LTD. DIMETHICONE 4 g/400mL N 20181231 53078-090_1402bb0c-a471-4ca6-8a47-f082684368a6 53078-090 HUMAN OTC DRUG DRH Ultimate Calming Mask Serum PURSLANE, CENTELLA ASIATICA, CHAMAEMELUM NOBILE FLOWER PATCH TOPICAL 20161001 UNAPPROVED DRUG OTHER NEW & NEW CO.,LTD. PURSLANE; CENTELLA ASIATICA; CHAMAEMELUM NOBILE FLOWER .28; .28; .02 g/28g; g/28g; g/28g N 20181231 53080-001_5d7aeba8-084a-ea07-e053-2a91aa0aee73 53080-001 HUMAN OTC DRUG Delta Airline Ron Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 Delta SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 53083-001_c5d56da7-e6dc-4fa8-891b-4ebe48d8fb91 53083-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20120601 UNAPPROVED MEDICAL GAS B & R Welder Repair Service, Inc OXYGEN 995 mL/L E 20171231 53093-433_59295ea1-e6a6-42df-8716-b25605d52a69 53093-433 HUMAN OTC DRUG Motto sulfur PATCH TRANSDERMAL 20130310 OTC MONOGRAPH FINAL part333D Motto-Elektro Ltd. SULFUR 9 mg/9mg E 20171231 53097-101_331af50e-8cf9-46f3-a8db-e76632739c92 53097-101 HUMAN PRESCRIPTION DRUG Thermazene Silver Sulfadiazine CREAM TOPICAL 20130701 NDA NDA018810 The Pharma Network LLC SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 53104-0100_8ddd3252-bafa-4bb3-83d9-1c7cde55da11 53104-0100 HUMAN PRESCRIPTION DRUG Zidovudine zidovudine CAPSULE ORAL 20070523 ANDA ANDA078349 Cipla Ltd. ZIDOVUDINE 100 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 53104-0101_01a39b6f-4cb5-45af-b698-e81c109caf14 53104-0101 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20101027 ANDA ANDA090561 Cipla Ltd. ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 53104-0105_ffd1d1d8-f8e4-40d5-b7cb-b78af6741a84 53104-0105 HUMAN PRESCRIPTION DRUG zidovudine zidovudine SYRUP ORAL 20080626 ANDA ANDA077981 Cipla Ltd. ZIDOVUDINE 50 mg/5mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 53104-0111_356b603d-44f0-4192-82f8-a859dfc28faa 53104-0111 HUMAN PRESCRIPTION DRUG stavudine stavudine FOR SOLUTION ORAL 20090320 ANDA ANDA078030 Cipla Ltd. STAVUDINE 1 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 53104-0166_e4fedf97-e2ce-4832-89dd-c9fd025b527f 53104-0166 HUMAN PRESCRIPTION DRUG nevirapine nevirapine TABLET ORAL 20120522 ANDA ANDA077956 Cipla Ltd. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 53113-100_a6f37e88-1493-4c23-8f17-3136964406ca 53113-100 HUMAN OTC DRUG Ice Quake Menthol GEL TOPICAL 20120823 OTC MONOGRAPH FINAL part348 Gadal Laboratories, Inc. MENTHOL 16.95 g/113g E 20171231 53113-101_64688b81-89cb-42bc-a7fe-8491b179911e 53113-101 HUMAN OTC DRUG Gadavyt Magnesium Citrate LIQUID ORAL 20121001 OTC MONOGRAPH FINAL part334 Gadal Laboratories Inc MAGNESIUM CITRATE 1.745 g/29.6mL E 20171231 53113-102_73057da3-ee31-4a5b-ba89-ca89b4d31895 53113-102 HUMAN OTC DRUG Gadavyt Magnesium Citrate LIQUID ORAL 20121001 OTC MONOGRAPH FINAL part334 Gadal Laboratories Inc MAGNESIUM CITRATE 1.745 g/29.6mL E 20171231 53113-103_f7e99784-d9f8-4c5f-8957-d178e8c0b351 53113-103 HUMAN OTC DRUG Gadavyt Magnesium Citrate LIQUID ORAL 20121001 OTC MONOGRAPH FINAL part334 Gadal Laboratories Inc MAGNESIUM CITRATE 1.745 g/29.6mL E 20171231 53113-104_b41d79c8-cdd2-410e-9921-3ca86f040b8f 53113-104 HUMAN OTC DRUG Gadavyt Enema dibasic sodium phosphate, monobasic sodium phosphate LIQUID RECTAL 20121001 OTC MONOGRAPH NOT FINAL part334 Gadal Laboratories Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 53113-105_d273c7e7-0dc8-4921-84d2-cf77f1f777eb 53113-105 HUMAN OTC DRUG Gadavyt Enema dibasic sodium phosphate, monobasic sodium phosphate LIQUID RECTAL 20121001 OTC MONOGRAPH NOT FINAL part334 Gadal Laboratories Inc SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 3.5; 9.5 g/59mL; g/59mL E 20171231 53113-108_3a135d16-cb5f-4ec6-815f-9993a96763cb 53113-108 HUMAN OTC DRUG Ice Quake Muscle Rub Menthol GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Gadal Laboratories Inc MENTHOL 2 g/100g E 20171231 53113-162_5a175b56-6c10-4c25-bf7a-91cc75374c51 53113-162 HUMAN OTC DRUG PRESTO ZINC OXIDE CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part347 GADAL Laboratories, Inc ZINC OXIDE 5 g/mL N 20181231 53113-215_c84aa6c7-3e51-4b6a-9fee-e6af3856f0ae 53113-215 HUMAN OTC DRUG Broncomar Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 Gadal Laboratories Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 250; 13.33; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL E 20171231 53113-216_9093948c-6ef7-48ce-b023-8d979a924cde 53113-216 HUMAN OTC DRUG Broncomar Maximum Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 Gadal Laboratories Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30; 200 mg/10mL; mg/10mL E 20171231 53113-217_19ec0ebe-5667-42f4-b790-076aa1d008b7 53113-217 HUMAN OTC DRUG Broncomar DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 Gadal Laboratories Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 53113-218_1f890f7c-0ae0-4746-ad5e-de73ba503801 53113-218 HUMAN OTC DRUG Broncomar SF Guaifenesin LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 Gadal Laboratories Inc GUAIFENESIN 100 mg/5mL E 20171231 53113-262_18d0cac1-584a-4679-8888-65051e73ebbd 53113-262 HUMAN OTC DRUG Gadaderm Hydrocortisone Hydrocortisone Acetate CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part348 Gadal Laboratories Inc HYDROCORTISONE ACETATE .5 g/100g E 20171231 53113-263_6636e999-6ece-4cab-8f36-1feb1802e9d1 53113-263 HUMAN OTC DRUG Gadaderm Antifungal Tolnaftate CREAM TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Gadal Laboratories Inc TOLNAFTATE 1 g/100g E 20171231 53113-266_f7c673c3-0b90-48b7-8b40-39179f3b79d8 53113-266 HUMAN OTC DRUG Ice Quake Plus Methyl Salicylate, Menthol, Camphor GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Gadal Laboratories Inc MENTHOL; METHYL SALICYLATE; CAMPHOR (SYNTHETIC) 10; 10; 3.1 g/100g; g/100g; g/100g E 20171231 53113-362_f65d52ae-8348-4691-b432-7ca05fad5fd3 53113-362 HUMAN OTC DRUG GADADERM Frozen Ice Advance Pain Relief SALICYLIC ACID MENTHOL CAMPHOR (NATURAL) GEL TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part348 GADAL Laboratories, Inc METHYL SALICYLATE; MENTHOL; CAMPHOR (NATURAL) 10; 10; 3.1 1/100g; 1/100g; 1/100g E 20171231 53113-363_e06290e3-85ad-4729-96b0-6f063c656081 53113-363 HUMAN OTC DRUG FROZEN ICE FAST PAIN RELIEF MENTHOL CAMPHOR (NATURAL) GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part348 GADAL Laboratories, Inc MENTHOL; CAMPHOR (NATURAL) 3.5; .2 g/100mL; g/100mL N 20181231 53113-550_4ef93a86-4d13-4465-bcb2-08367c587b23 53113-550 HUMAN OTC DRUG Gadavyt Cough GUAIFENESIN LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Gadal Laboratories Inc GUAIFENESIN 100 mg/5mL E 20171231 53113-557_77ed1487-5de6-47c6-b4e1-abaf25512649 53113-557 HUMAN OTC DRUG Gadavyt Cough DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Gadal Laboratories Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 53113-657_7aa6375e-6789-4465-967b-9d3ddeac3635 53113-657 HUMAN OTC DRUG Gadavyt Loperamide HCl Loperamide Hydrochloride LIQUID ORAL 20130501 UNAPPROVED DRUG OTHER Gadal Laboratories Inc LOPERAMIDE HYDROCHLORIDE 1 mg/5mL E 20171231 53113-688_6720c67b-21f5-485d-90e1-c40bad7dd1f6 53113-688 HUMAN OTC DRUG Ice Quake White Methyl Salicylate, Menthol CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Gadal Laboratories Inc MENTHOL; METHYL SALICYLATE 2; 8 g/100g; g/100g E 20171231 53117-224_e0ac696c-5d90-4abb-ad6e-43e039c29fea 53117-224 HUMAN OTC DRUG fad first aid direct anti-diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20141015 ANDA ANDA075232 First Aid Direct LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 53117-612_d86c8340-23f4-4e10-8634-ce7bc5fb3608 53117-612 HUMAN OTC DRUG fad first aid direct allergy relief Loratadine TABLET ORAL 20121219 ANDA ANDA076301 First Aid Direct LORATADINE 10 mg/1 N 20181231 53118-001_80bdd931-1ff8-467f-881b-be94a06adb25 53118-001 HUMAN OTC DRUG Sanitex Antibacterial Hand Wipes Citrus Scent Benzalkonium Chloride SWAB TOPICAL 20150618 OTC MONOGRAPH NOT FINAL part333A PREMIER CARE INDUSTRIES, INC BENZALKONIUM CHLORIDE .26 g/100g N 20181231 53118-002_0de21952-aca2-4dc3-8859-87ae26600779 53118-002 HUMAN OTC DRUG Sanitex Antibacterial Hand Wipes Fresh Scent Benzalkonium Chloride SWAB TOPICAL 20150617 OTC MONOGRAPH NOT FINAL part333A PREMIER CARE INDUSTRIES, INC BENZALKONIUM CHLORIDE .26 g/100g N 20181231 53119-575_78e78f82-6420-4685-9d37-588346d05ef9 53119-575 HUMAN OTC DRUG TRICLOSAN TRICLOSAN LIQUID TOPICAL 20101011 OTC MONOGRAPH NOT FINAL part333A Columbia Jobbing TRICLOSAN 3.15 g/1000mL E 20171231 53125-717_6c4af7e5-f4cd-4c2f-aedd-a549e3ce2776 53125-717 HUMAN OTC DRUG North Woods Derma Foam E-2 Benzalkonium Chloride SOAP TOPICAL 20160915 OTC MONOGRAPH NOT FINAL part333A Superior Chemical Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 53125-751_8e700a54-a2f0-4a00-9146-f821ca347079 53125-751 HUMAN OTC DRUG North Woods DermaFoam Premium Antibacterial Triclosan SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Superior Chemical Corporation TRICLOSAN 3 mg/mL N 20181231 53125-752_b6b301ad-4fa7-4700-a25c-2a0f15b24dcd 53125-752 HUMAN OTC DRUG North Woods Derma Foam Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Superior Chemical Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 53125-773_3c5a115e-f5cd-4303-86b1-4d888ad73958 53125-773 HUMAN OTC DRUG Sani Mousse ALCOHOL AEROSOL, FOAM TOPICAL 20120904 OTC MONOGRAPH NOT FINAL part333E Superior Chemical Corporation ALCOHOL 620 mg/g E 20171231 53125-785_d04c7c23-545c-4bd9-9107-5a464042abc8 53125-785 HUMAN OTC DRUG Soapy Hands BENZETHONIUM CHLORIDE CLOTH TOPICAL 20120904 OTC MONOGRAPH NOT FINAL part333E Superior Chemical Corporation BENZETHONIUM CHLORIDE 2 mg/g E 20171231 53135-825_1463ef83-ef5e-4eb6-bbf9-a8a63e6256ce 53135-825 HUMAN OTC DRUG Amazing Grace Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex gly STICK TOPICAL 20100228 OTC MONOGRAPH NOT FINAL part352 Raani Corporation ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g E 20171231 53135-833_de59a033-f0e3-4fe6-8f26-c0891096390a 53135-833 HUMAN OTC DRUG ZUSKA VIVA ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20100123 OTC MONOGRAPH FINAL part350 RAANI CORPORATION ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 180 mg/g E 20171231 53135-835_08968d67-89ec-4230-857d-7ff92a25d20d 53135-835 HUMAN OTC DRUG ZUSKA ODYSSEY ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20091123 OTC MONOGRAPH FINAL part350 RAANI CORPORATION ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 180 mg/g E 20171231 53135-837_93beac96-ca2e-46a2-9662-3e1d8d24acba 53135-837 HUMAN OTC DRUG ZUSKA ICON ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20091123 OTC MONOGRAPH FINAL part350 RAANI CORPORATION ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 180 mg/g E 20171231 53135-838_d782bd0c-2708-45a8-a968-386fa85bdcde 53135-838 HUMAN OTC DRUG ZUSKA RHYTHM ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20101230 OTC MONOGRAPH FINAL part350 RAANI CORPORATION ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 180 mg/g E 20171231 53135-925_8e1f802e-324e-47af-ba15-c35f4ec8690c 53135-925 HUMAN OTC DRUG Pure Grace Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20100228 OTC MONOGRAPH NOT FINAL part352 Raani Corporation ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 180 mg/g E 20171231 53135-967_f977a79a-1650-4048-87fe-661a4c47f133 53135-967 HUMAN OTC DRUG LACURA FOR MEN ULTIMATE ENDURANCE Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20101108 OTC MONOGRAPH FINAL part350 RAANI CORPORATION ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 200 mg/g E 20171231 53144-1001_9b035360-3432-44e8-9e2b-ff955422c493 53144-1001 HUMAN OTC DRUG Mesima PHELLINUS LINTEUS MYCELIUM CAPSULE ORAL 20121229 UNAPPROVED DRUG OTHER Yein Trading & Global Co., Ltd PHELLINUS LINTEUS MYCELIUM 1.1 1/1 N 20181231 53144-2001_46ab2ed2-7798-415d-8b8b-64935e1a35f0 53144-2001 HUMAN OTC DRUG Messima EX PHELLINUS LINTEUS MYCELIUM POWDER ORAL 20121229 UNAPPROVED DRUG OTHER Yein Trading & Global Co., Ltd PHELLINUS LINTEUS MYCELIUM 1.1 g/1.1g N 20181231 53144-3001_a32e5228-31a4-4d90-aabb-40e177bf72fe 53144-3001 HUMAN OTC DRUG IMG PHELLINUS LINTEUS MYCELIUM TABLET ORAL 20130216 UNAPPROVED DRUG OTHER Yein Trading & Global Co., Ltd PHELLINUS LINTEUS MYCELIUM .022 1/1 N 20181231 53144-4001_c73f23f9-2564-4a47-96c2-d3b63252dd67 53144-4001 HUMAN OTC DRUG Chidangwon 300 LAGERSTROEMIA INDICA WHOLE TABLET ORAL 20130105 UNAPPROVED DRUG OTHER Yein Trading & Global Co., Ltd LAGERSTROEMIA INDICA WHOLE .018 1/1 N 20181231 53145-002_4000c212-7fc1-47b8-a4c0-29fce9835e3d 53145-002 HUMAN OTC DRUG Hielo Ardiente Menthol GEL TOPICAL 20120221 OTC MONOGRAPH NOT FINAL part348 Menper Distributors, Inc. MENTHOL 4840 mg/g N 20181231 53145-004_b5cbae0b-7809-454d-86fe-225fdcfb2dd0 53145-004 HUMAN OTC DRUG Aseptil Rojo Phenol LIQUID ORAL 20120221 OTC MONOGRAPH NOT FINAL part348 Menper Distributors, Inc. PHENOL 1 mg/mL N 20181231 53145-005_d8f8b1db-ffd9-4f76-922f-93bdad0ab376 53145-005 HUMAN OTC DRUG Defensol D Acetaminophen, Chlorpherinamine maleate, Phenylephrine HCI TABLET ORAL 20120221 OTC MONOGRAPH NOT FINAL part343 Menper Distributors, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 53145-006_6c393469-4661-48e4-89e0-8414b8ee010c 53145-006 HUMAN OTC DRUG Defensolito Acetaminophen, Phenylephrine Hydrochloride TABLET, CHEWABLE ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 80; 2.5 mg/1; mg/1 N 20181231 53145-007_29b9aebb-404c-4d99-8db1-11b65625c94f 53145-007 HUMAN OTC DRUG Breacold Children Guaifenesin, Dextromethorphan HBR LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/15mL; mg/15mL N 20181231 53145-008_1bc2e2b0-0502-4b4d-aa62-7594f0b7f9b0 53145-008 HUMAN OTC DRUG Defensolito Children Syrup Guaifenesin, Dextromethorphan HBR LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/15mL; mg/15mL N 20181231 53145-013_55775984-1c69-4fb1-a868-ab170d3071bc 53145-013 HUMAN OTC DRUG Duralgina Acetaminophen TABLET ORAL 20170101 OTC MONOGRAPH NOT FINAL part343 Menper Distributors Inc. ACETAMINOPHEN 325 mg/1 N 20181231 53145-019_8e4174ab-f00c-4381-be54-0bec5909526c 53145-019 HUMAN OTC DRUG Hongocura Pinceladas Undecylenic Acid LIQUID TOPICAL 20120221 OTC MONOGRAPH FINAL part333C Menper Distributors, Inc. UNDECYLENIC ACID 200 mg/mL N 20181231 53145-022_837fac56-d098-4c1f-ba33-146f3f235ed1 53145-022 HUMAN OTC DRUG Callicide Corn and Callus Remover Salicylic acid OINTMENT TOPICAL 20120221 OTC MONOGRAPH FINAL part358B Menper Distributors, Inc. SALICYLIC ACID 5 g/g N 20181231 53145-026_7b0c81cd-8148-4653-8b65-97e4976e5c35 53145-026 HUMAN OTC DRUG Broncofin Broncofin LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 10; 5 mg/5mL; mg/5mL N 20181231 53145-030_135c2e98-0fa6-472c-b9b3-c867048d7ea0 53145-030 HUMAN OTC DRUG Bronco Pulmonar Syrup Guaifenesin, Dextromethrophan HBR LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 53145-031_c4d0389a-acfc-4fd0-a45b-7e7d90e26da0 53145-031 HUMAN OTC DRUG Pulmovac Guaifenesin, Dextromethorphan HBR LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 53145-032_63464087-a8dd-43b7-b81e-be9e9c8bf1ce 53145-032 HUMAN OTC DRUG Bronkisan Guaifenesin, Dextromethorphan HBR LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 53145-039_f85cebbf-fd88-4733-9c33-169cf8a1cbce 53145-039 HUMAN OTC DRUG Defensol Adult Syrup Guaifenesin, Dextromethorphan HBR LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 53145-040_36d6a815-d6ec-4839-a38a-b45b032c95c7 53145-040 HUMAN OTC DRUG Breacold Adult Guaifenesin, Dextromethorphan HBr LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 53145-047_4fdb91df-9460-4be2-8993-09d13f5786e5 53145-047 HUMAN OTC DRUG La Flecha Japonesa Methyl salicylate OIL TOPICAL 20120221 OTC MONOGRAPH FINAL part348 Menper Distributors, Inc. METHYL SALICYLATE 105 mg/mL N 20181231 53145-052_d8db724d-0259-45d3-948a-6fe7534bd79d 53145-052 HUMAN OTC DRUG Gesteira Acetaminophen LIQUID ORAL 20120221 OTC MONOGRAPH NOT FINAL part343 Menper Distributors, Inc. ACETAMINOPHEN 675 mg/675mL N 20181231 53145-053_70fc35ba-e6e8-4602-a03c-89b26d943b03 53145-053 HUMAN OTC DRUG Dolofin Infantil Acetaminophen LIQUID ORAL 20120221 OTC MONOGRAPH NOT FINAL part343 Menper Distributors, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 53145-055_dbe747fb-16c7-4426-b1af-e40daec0ccd4 53145-055 HUMAN OTC DRUG Bismutina Bismuth Subsalycilate LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part335 Menper Distributors, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 53145-056_135d901a-8b0f-4b1a-978d-bf2a5623558b 53145-056 HUMAN OTC DRUG Pomada de Sulfa Neomycin sulfate OINTMENT TOPICAL 20120221 OTC MONOGRAPH FINAL part333B Menper Distributors, Inc. NEOMYCIN SULFATE 3.5 mg/57g N 20181231 53145-057_1709678e-0432-4fb5-a029-56b43b25b92b 53145-057 HUMAN OTC DRUG Threda Bismuth Subsalycilate LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part335 Menper Distributors, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 53145-059_5214881e-6a73-4631-af49-cb3f55439a84 53145-059 HUMAN OTC DRUG Cosedal Drops Dextromethorphan HBR, Guaifenesin LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 53145-060_4d97128d-74b9-43ec-b70e-6f73787d5b19 53145-060 HUMAN OTC DRUG Magmex Magnesium hydroxide LIQUID ORAL 20120221 OTC MONOGRAPH NOT FINAL part334 Menper Distributors, Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 53145-101_65f9fe4a-c479-442a-bfa6-63c2e618f5f2 53145-101 HUMAN OTC DRUG PARASITOL PYRANTEL PAMOATE SUSPENSION ORAL 20130101 OTC MONOGRAPH FINAL part357B Menper Distributors Inc. PYRANTEL PAMOATE 144 mg/mL N 20181231 53145-119_227c277a-756f-4084-940d-bdaa21b032e1 53145-119 HUMAN OTC DRUG Pinceladas Para Hongos Navarro Undecylenic Acid LIQUID TOPICAL 20120221 OTC MONOGRAPH FINAL part333C Menper Distributors, Inc. UNDECYLENIC ACID 200 mg/mL N 20181231 53145-219_e3d1f194-2c7c-4a6b-9561-7d5cf1cd38d6 53145-219 HUMAN OTC DRUG Hongocura M Undecylenic Acid LIQUID TOPICAL 20120221 OTC MONOGRAPH FINAL part333C Menper Distributors, Inc. UNDECYLENIC ACID 200 mg/mL N 20181231 53145-300_23697a99-ce4b-4d28-a939-07846f82f9d7 53145-300 HUMAN OTC DRUG Anti-Empacho Sodium Bicarbonate LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part331 Menper Distributors, Inc. SODIUM BICARBONATE 525 mg/15mL N 20181231 53145-301_7c7683b5-919d-4701-b7c3-7ce50f79b025 53145-301 HUMAN OTC DRUG Anestenka Benzocaine LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part356 Menper Distributors, Inc BENZOCAINE .2 mg/2mL N 20181231 53145-302_8aaad35b-e249-4928-9825-736a01636679 53145-302 HUMAN OTC DRUG Toa Syrup Adult Toa Syrup Adult LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE 10; 5 mg/5mL; mg/5mL N 20181231 53145-303_55597310-68c6-4c0d-a03e-06143bc868e0 53145-303 HUMAN OTC DRUG Veneno de Abeja Aceite De Vibora Brand Methyl Salicylate OINTMENT TOPICAL 20110510 OTC MONOGRAPH NOT FINAL part348 Menper Distributors Inc. METHYL SALICYLATE 10.5 g/90g N 20181231 53145-304_903c6d7b-b183-4220-b095-2dee68f7473e 53145-304 HUMAN OTC DRUG Polvos de Sulpha First Aid Antibiotic Bacitracin Zinc, Polymyxin B Sulfate POWDER TOPICAL 20061211 OTC MONOGRAPH FINAL part333B Menper Distributors Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 1/7.5g; 1/7.5g N 20181231 53145-308_24ca5876-b7fc-4dd4-88c3-f0c99f2191d3 53145-308 HUMAN OTC DRUG LIENDREX PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE SHAMPOO TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part358G Menper Distributors Inc. PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .3 g/100mL; g/100mL N 20181231 53145-311_f92efaed-9045-4282-a9ab-7449549cf5ea 53145-311 HUMAN OTC DRUG Auralyt Carbamide Peroxide LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part344 Menper Distributors, Inc CARBAMIDE PEROXIDE 7.8 mg/12mL N 20181231 53145-319_9c47eefb-590a-4073-84e6-9ad91d93fc45 53145-319 HUMAN OTC DRUG Hongocura S Undecylenic Acid LIQUID TOPICAL 20120221 OTC MONOGRAPH FINAL part333C Menper Distributors, Inc. UNDECYLENIC ACID 200 mg/mL N 20181231 53145-320_cebe9de8-5579-4129-8a93-3ac761ac3784 53145-320 HUMAN OTC DRUG Defensol D (Multi Symptom Effervescent Tablets) Acetaminophen 250mg, Chlorpheniramine maleate 2mg, Dextromethorphan hydrobromide 10mg, Phenylephrine hydrochloride 5mg TABLET, EFFERVESCENT ORAL 20151201 OTC MONOGRAPH FINAL part341 Menper Distributors Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 250; 2; 10; 5 mg/2501; mg/2501; mg/2501; mg/2501 N 20181231 53145-321_8703a2fc-23ae-4432-8a03-da49a1b166ca 53145-321 HUMAN OTC DRUG Bisolvine Adult Guaifenesin, Dextromethorphan LIQUID ORAL 20100201 OTC MONOGRAPH FINAL part341 MENPER DISTRIBUTORS INC. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 100; 10 mg/5mL; mg/5mL N 20181231 53145-333_f94a0a87-0b80-4e16-9f46-5fb5456976e9 53145-333 HUMAN OTC DRUG Defensol-ito Dextromethorphan, Guiafenesin, Phenylephrine SOLUTION ORAL 20140101 OTC MONOGRAPH FINAL part341 Menper Distributors, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 4; 50; 2.5 mg/mL; mg/mL; mg/mL N 20181231 53145-335_ccac2d80-0d85-4154-8a92-8806fa1e6569 53145-335 HUMAN OTC DRUG Nene Dente Benzocaine LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part356 Menper Distributors, Inc BENZOCAINE 2.1 mg/30mL N 20181231 53145-390_d3ee932c-76d0-41f1-b30f-a2e703f6ab36 53145-390 HUMAN OTC DRUG Sodium Bicarbonate Antacid Sodium Bicarbonate POWDER ORAL 20170101 OTC MONOGRAPH FINAL part331 Menper Distributors Inc. SODIUM BICARBONATE 2.616 g/2.616g N 20181231 53145-401_98b4948a-5421-4ef1-bc30-280304ea28fc 53145-401 HUMAN OTC DRUG Balsamo de Ubre Mascura Methyl Salicylate OINTMENT TOPICAL 20110510 OTC MONOGRAPH NOT FINAL part348 Menper Distributors Inc. METHYL SALICYLATE 10.5 g/90g N 20181231 53145-420_58252991-1ad6-4125-b680-9c0f90f46c51 53145-420 HUMAN OTC DRUG Dolofin Acetaminophen TABLET ORAL 20170101 OTC MONOGRAPH NOT FINAL part343 Menper Distributors Inc. ACETAMINOPHEN 325 mg/1 N 20181231 53145-902_c358c024-0651-4416-95a1-31e4a1e859d2 53145-902 HUMAN OTC DRUG Baby Anestenka Benzocaine LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part356 Menper Distributors BENZOCAINE 2.1 mg/30mL N 20181231 53149-2100_a1ebaa99-b305-4cc5-9817-563b0c93a202 53149-2100 HUMAN OTC DRUG NuLido Lidocaine Hydrocloride 4% GEL TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part348 All Pharma LLC LIDOCAINE; MENTHOL 4; 1 mg/mL; mg/mL N 20181231 53149-4840_58f99fbc-f5d8-4cfb-affd-a0bff0e3375b 53149-4840 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20100601 ANDA ANDA077789 All Pharma, LLC CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 53149-4841_d6652f0c-2b9b-46a0-bc6a-6118865d1d0e 53149-4841 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20150325 ANDA ANDA078722 All Pharma, LLC CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 53149-9074_f1c128ba-6c24-4178-b3b3-61dabb6565bd 53149-9074 HUMAN PRESCRIPTION DRUG SPEEDGEL RX ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE GEL TRANSDERMAL 20111201 UNAPPROVED HOMEOPATHIC All Pharma, LLC ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE; GINGER 1; 1; 3; 1; 1; 1; 3; 1; 1; 1; 1; 3; 3; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 53150-209_87bed912-1bb0-4527-a25e-f4447baf564c 53150-209 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET ORAL 20140430 ANDA ANDA078195 Amneal-Agila, LLC NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] E 20171231 53150-247_fa3e9573-f016-49ed-9ec8-1da4c07274f1 53150-247 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION INTRAVENOUS 20130731 ANDA ANDA091599 Amneal-Agila, LLC EPIRUBICIN HYDROCHLORIDE 200 mg/100mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] E 20171231 53150-250_fa3e9573-f016-49ed-9ec8-1da4c07274f1 53150-250 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION INTRAVENOUS 20130731 ANDA ANDA091599 Amneal-Agila, LLC EPIRUBICIN HYDROCHLORIDE 50 mg/25mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] E 20171231 53150-314_7e9e34a5-0865-4193-aa65-41a7b87821dc 53150-314 HUMAN PRESCRIPTION DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride INJECTION INTRAVENOUS 20130430 ANDA ANDA200901 Amneal-Agila, LLC DOXORUBICIN HYDROCHLORIDE 20 mg/10mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] E 20171231 53150-315_7e9e34a5-0865-4193-aa65-41a7b87821dc 53150-315 HUMAN PRESCRIPTION DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride INJECTION INTRAVENOUS 20130430 ANDA ANDA200901 Amneal-Agila, LLC DOXORUBICIN HYDROCHLORIDE 50 mg/25mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] E 20171231 53150-317_7e9e34a5-0865-4193-aa65-41a7b87821dc 53150-317 HUMAN PRESCRIPTION DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride INJECTION INTRAVENOUS 20130430 ANDA ANDA200901 Amneal-Agila, LLC DOXORUBICIN HYDROCHLORIDE 200 mg/100mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] E 20171231 53150-320_7e9e34a5-0865-4193-aa65-41a7b87821dc 53150-320 HUMAN PRESCRIPTION DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride INJECTION INTRAVENOUS 20130430 ANDA ANDA200901 Amneal-Agila, LLC DOXORUBICIN HYDROCHLORIDE 10 mg/5mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] E 20171231 53150-415_539951c7-0516-4970-86db-84fe6b95d813 53150-415 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Amneal-Agila, LLC HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] E 20171231 53150-422_539951c7-0516-4970-86db-84fe6b95d813 53150-422 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Amneal-Agila, LLC HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] E 20171231 53150-485_539951c7-0516-4970-86db-84fe6b95d813 53150-485 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Amneal-Agila, LLC HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] E 20171231 53150-489_539951c7-0516-4970-86db-84fe6b95d813 53150-489 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Amneal-Agila, LLC HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] E 20171231 53150-871_d4595229-52b1-4ddb-8fcf-d9422406ca43 53150-871 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20120423 ANDA ANDA202650 Amneal-Agila, LLC ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 53152-1004_5f6fcb2b-aa3b-47bb-b6e1-c82ba6779676 53152-1004 HUMAN OTC DRUG Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120828 OTC MONOGRAPH NOT FINAL part333E AOSS Medical Supply, Inc. ALCOHOL 62 mL/100mL N 20181231 53152-1008_8215e149-2384-4ce8-9d87-50763df93da8 53152-1008 HUMAN OTC DRUG Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120828 OTC MONOGRAPH NOT FINAL part333E AOSS Medical Supply, Inc. ALCOHOL 62 mL/100mL N 20181231 53153-101_c541071e-4a5e-4e87-83ad-7ac34962437c 53153-101 HUMAN OTC DRUG HANSHINNOCOL Acetaminophen, Cholorpheniramine Maleate, Dextromethorphan Hydrobromide LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Han Kook Shin Yak Pharmaceutical Co., Ltd. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 200; 2.5; 15 mg/30mL; mg/30mL; mg/30mL N 20181231 53153-102_e4bc9c70-ea30-4980-8a87-c50510377aef 53153-102 HUMAN OTC DRUG HANSHINNOCOL Acetaminophen, Cholorpheniramine Maleate, Dextromethorphan Hydrobromide CAPSULE ORAL 20150630 OTC MONOGRAPH FINAL part341 Han Kook Shin Yak Pharmaceutical Co., Ltd. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 100; 1.25; 7.5 mg/500mg; mg/500mg; mg/500mg N 20181231 53157-000_eab5a1f9-bed2-4a42-9544-d5912cd267b8 53157-000 HUMAN PRESCRIPTION DRUG LeukoTrap SOLX B Additive AS-7 B Additive Solution SOLUTION INTRAVENOUS 20151112 NDA NDA110059 Haemonetics Manufacturing Inc DEXTROSE, UNSPECIFIED FORM 1.78 g/30mL E 20171231 53157-002_eab5a1f9-bed2-4a42-9544-d5912cd267b8 53157-002 HUMAN PRESCRIPTION DRUG LeukoTrap SOLX A Additive AS-7 A Additive Solution SOLUTION INTRAVENOUS 20151112 NDA NDA110059 Haemonetics Manufacturing Inc ADENINE; MANNITOL .03; 1.1 g/80mL; g/80mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] E 20171231 53157-100_25edc224-0331-45f2-842d-cc2b9514a9da 53157-100 HUMAN PRESCRIPTION DRUG Nutricel Additive Solution - CP2D CP2D/AS-3 Anticoagulant and Additive System SOLUTION INTRAVENOUS 20130913 NDA BN820915 Haemonetics Manufacturing Inc. DEXTROSE 3.57 g/70mL E 20171231 53157-101_25edc224-0331-45f2-842d-cc2b9514a9da 53157-101 HUMAN PRESCRIPTION DRUG Nutricel Additive Solution - AS-3 CP2D/AS-3 Anticoagulant and Additive System SOLUTION INTRAVENOUS 20130913 NDA BN820915 Haemonetics Manufacturing Inc. DEXTROSE; ADENINE 1.21; .033 g/110mL; g/110mL E 20171231 53157-123_1fe72177-6c12-4e3f-8895-b9d3ba994d9b 53157-123 HUMAN PRESCRIPTION DRUG Leukotrap - CP2D Solution Anticoagulant Citrate Phosphate Double Dextrose SOLUTION INTRAVENOUS 19831109 NDA NDA820915 Haemonetics Manufacturing Inc DEXTROSE 3.57 g/70mL E 20171231 53157-124_1fe72177-6c12-4e3f-8895-b9d3ba994d9b 53157-124 HUMAN PRESCRIPTION DRUG Leukotrap - AS-3 Solution Additive Solution - 3 SOLUTION INTRAVENOUS 19831109 NDA NDA820915 Haemonetics Manufacturing Inc DEXTROSE; ADENINE 1.21; .033 g/110mL; g/110mL E 20171231 53157-129_028e6f14-34f2-49f4-99a5-83c457d4e96f 53157-129 HUMAN PRESCRIPTION DRUG Leukotrap Blood Collection System KIT 19830922 NDA NDA820915 Haemonetics Manufacturing Inc E 20171231 53157-130_145f874d-bba2-42b7-a7f5-63c43bce506e 53157-130 HUMAN PRESCRIPTION DRUG CPDA-1 Blood Collection System Blood Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc DEXTROSE MONOHYDRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; .229; .155; .019 g/70mL; g/70mL; g/70mL; g/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII E 20171231 53157-136_b47462f0-b43f-470f-a3f7-4ce17a14a769 53157-136 HUMAN PRESCRIPTION DRUG Leukotrap WB System CPDA-1 Blood Bag Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc DEXTROSE MONOHYDRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; .229; .155; .019 g/70mL; g/70mL; g/70mL; g/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII E 20171231 53157-136_cd05ee40-f7de-4d1b-b701-648ff2dfdb3e 53157-136 HUMAN PRESCRIPTION DRUG Leukotrap WB System CPDA-1 Blood Bag Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc DEXTROSE MONOHYDRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; .229; .155; .019 g/70mL; g/70mL; g/70mL; g/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII E 20171231 53157-136_fdd00e7b-039a-48a8-b654-941f85f5c00f 53157-136 HUMAN PRESCRIPTION DRUG Leukotrap WB System CPDA-1 Blood Bag Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc DEXTROSE MONOHYDRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.23; 1.84; .229; .155; .019 g/70mL; g/70mL; g/70mL; g/70mL; g/70mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII E 20171231 53157-300_795f1082-9ede-47cb-9a22-5092787ecbb3 53157-300 HUMAN PRESCRIPTION DRUG LEUKOSEP - CPD Solution Citrate Phosphate Dextrose (CPD) Solution SOLUTION INTRAVENOUS 20130515 NDA NDA110059 Haemonetics Manufacturing Inc DEXTROSE 1.78 g/70mL E 20171231 53157-301_795f1082-9ede-47cb-9a22-5092787ecbb3 53157-301 HUMAN PRESCRIPTION DRUG LEUKOSEP - SOLX B ADDITIVE SOLUTION SOLX B ADDITIVE SOLUTION SOLUTION INTRAVENOUS 20130515 NDA NDA110059 Haemonetics Manufacturing Inc DEXTROSE 1.78 g/30mL E 20171231 53157-303_795f1082-9ede-47cb-9a22-5092787ecbb3 53157-303 HUMAN PRESCRIPTION DRUG LEUKOSEP - SOLX A ADDITIVE SOLUTION SOL A ADDITIVE SOLUTION SOLUTION INTRAVENOUS 20130515 NDA NDA110059 Haemonetics Manufacturing Inc ADENINE; MANNITOL 30; 1.1 mg/80mL; g/80mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] E 20171231 53157-326_eab5a1f9-bed2-4a42-9544-d5912cd267b8 53157-326 HUMAN PRESCRIPTION DRUG LeukoTrap CPD Solution Citrate Phosphate Dextrose (CPD) Solution SOLUTION INTRAVENOUS 20151112 NDA NDA110059 Haemonetics Manufacturing Inc DEXTROSE, UNSPECIFIED FORM 1.78 g/70mL E 20171231 53157-730_949abd84-24b2-4e38-8640-12073408d46b 53157-730 HUMAN PRESCRIPTION DRUG CPDA-1 Blood Collection System Blood Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc DEXTROSE MONOHYDRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.01; 1.66; .206; .14; .017 g/63mL; g/63mL; g/63mL; g/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII E 20171231 53157-736_744a75d7-c324-4999-80c6-50612d067835 53157-736 HUMAN PRESCRIPTION DRUG Leukotrap WB System CPDA-1 Blood Bag Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc DEXTROSE MONOHYDRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.01; 1.66; .206; .14; .017 g/63mL; g/63mL; g/63mL; g/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII E 20171231 53157-736_b2064cb0-542d-41d4-82ef-e7e6a53b9400 53157-736 HUMAN PRESCRIPTION DRUG Leukotrap WB System CPDA-1 Blood Bag Collection System SOLUTION INTRAVENOUS 19801106 NDA NDA800077 Haemonetics Manufacturing Inc DEXTROSE MONOHYDRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ADENINE 2.01; 1.66; .206; .14; .017 g/63mL; g/63mL; g/63mL; g/63mL; g/63mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII E 20171231 53157-796_ec28b740-2fd1-453e-9ee9-1aa20d223d6c 53157-796 HUMAN PRESCRIPTION DRUG ACD-A Anticoagulant Citrate Dextrose Solution A SOLUTION INTRAVENOUS 19871106 NDA NDA710497 Haemonetics Manufacturing Inc DEXTROSE MONOHYDRATE; SODIUM CITRATE; CITRIC ACID MONOHYDRATE 2.45; 2.2; .73 g/100mL; g/100mL; g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 53157-798_1a2ad203-63fe-42ac-88c6-23dd28385005 53157-798 HUMAN PRESCRIPTION DRUG Sodium Citrate Anticoagulant Sodium Citrate Solution SOLUTION INTRAVENOUS 19780630 NDA NDA760305 Haemonetics Manufacturing Inc SODIUM CITRATE 10 g/250mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] CII E 20171231 53163-101_e5d7a636-0d7e-46a6-baa1-149e464360ae 53163-101 HUMAN OTC DRUG Altipres-B BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20121101 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 20; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 53163-103_f4bd02c9-15ba-43c6-8200-9eec2cef3cfe 53163-103 HUMAN OTC DRUG Altipres Pediatric Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20130501 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 75; 2.5 mg/5mL; mg/5mL; mg/5mL N 20191231 53163-104_213227a4-028b-4bdd-b505-db2454353964 53163-104 HUMAN OTC DRUG Altipres Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20130501 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/5mL; mg/5mL; mg/5mL N 20191231 53163-106_a8d5f774-c8ba-44b8-a73d-9f109a378d60 53163-106 HUMAN OTC DRUG Igualtuss Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140301 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 28; 388; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 53163-107_4cb6d55c-66c7-4d40-a95b-3710d584bbb6 53163-107 HUMAN OTC DRUG Alticotron Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20150301 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/mL; mg/mL; mg/mL N 20181231 53163-108_bb9fbcd2-f3e0-4718-ac6c-30514bc9d653 53163-108 HUMAN OTC DRUG Altidesp Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl SOLUTION/ DROPS ORAL 20150301 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 50; 2.5 mg/mL; mg/mL; mg/mL N 20181231 53163-113_f6b59b2c-9e11-4fda-9cd3-7cc524923319 53163-113 HUMAN OTC DRUG Altituss Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150301 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 15; 150 mg/7.5mL; mg/7.5mL N 20181231 53163-114_e57fbe2d-cd28-4331-820f-f9a331ceca4f 53163-114 HUMAN OTC DRUG Altilan CL Dextromethorphan HBr, Phenylephrine HCl, Chlorpheniramine Maleate LIQUID ORAL 20150301 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE 15; 10; 4 mg/5mL; mg/5mL; mg/5mL N 20181231 53163-251_a99931b2-8fe8-451d-8151-937201cce40e 53163-251 HUMAN OTC DRUG Altidome DMX Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20131101 OTC MONOGRAPH FINAL part341 Alternative Pharmacal Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 30; 200; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 53173-0001_e057654f-0aa2-45e2-b780-e7306ca53a32 53173-0001 HUMAN OTC DRUG Sore Throat Echinacea Purpurea, Plantago Major, Baptisia Tinctoria, Phytolacca Decandra, Apis Mellifica, Belladonna, Lachesis Mutus, Mercurius Solubilis, Hepar Sulphuris Calcareum SPRAY ORAL 20151009 UNAPPROVED HOMEOPATHIC Nova Aurora Corp ECHINACEA PURPUREA; PLANTAGO MAJOR; BAPTISIA TINCTORIA ROOT; PHYTOLACCA AMERICANA ROOT; APIS MELLIFERA; ATROPA BELLADONNA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; CALCIUM SULFIDE 2; 2; 3; 3; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 53174-000_4923db36-e791-592b-e054-00144ff8d46c 53174-000 HUMAN OTC DRUG Army Health Pain Reliever MENTHOL GEL TOPICAL 20120824 OTC MONOGRAPH NOT FINAL part348 Cas Group International MENTHOL 30 mg/mL N 20181231 53175-001_0080f25e-875d-4fea-a64d-307b8e59c145 53175-001 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20120910 OTC MONOGRAPH NOT FINAL part356 Dyad Medical Sourcing, LLC HYDROGEN PEROXIDE 3 mL/100mL N 20181231 53175-002_df8c16a6-e426-4743-b7c1-baf8ffce02f7 53175-002 HUMAN OTC DRUG HCS Roll-On Antiperspirant Aluminum Chlorohydrate LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Dyad Medical Sourcing, LLC ALUMINUM CHLOROHYDRATE 78 mg/mL N 20181231 53175-003_2cce196a-05b8-4bf0-b433-75539f84ba8f 53175-003 HUMAN OTC DRUG Triclosan Triclosan SOAP TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part333E Dyad Medical Sourcing, LLC TRICLOSAN .2 g/100g N 20181231 53175-810_a356e98a-77e7-4df6-b378-c4d68f3b8c95 53175-810 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part333A Dyad Medical Sourcing, LLC ISOPROPYL ALCOHOL .7 mg/mL N 20191231 53185-001_40b98f0d-90e9-6caa-e054-00144ff8d46c 53185-001 HUMAN OTC DRUG Clear Choice Allergy Relief CHLORPHENIRAMINE MALEATE TABLET ORAL 20120823 OTC MONOGRAPH FINAL part341 Athlete's Needs Inc CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 53185-002_5784d5fa-cac8-38c5-e053-2a91aa0aba63 53185-002 HUMAN OTC DRUG Clear Choice Extra Strength Pain Reliever ACETAMINOPHEN TABLET ORAL 20120913 OTC MONOGRAPH NOT FINAL part343 Athlete's Needs Inc ACETAMINOPHEN 500 mg/1 N 20181231 53185-003_40b9968a-8fd9-5ed9-e054-00144ff88e88 53185-003 HUMAN OTC DRUG Clear Choice Ibuprofen IBUPROFEN TABLET ORAL 20121009 ANDA ANDA079129 Athlete's Needs Inc IBUPROFEN 200 mg/1 E 20171231 53185-004_5784dfa2-1c44-2bf7-e053-2a91aa0a4226 53185-004 HUMAN OTC DRUG Clear Choice Naproxen Sodium Naproxen Sodium TABLET ORAL 20130506 ANDA ANDA079096 Athlete's Needs Inc NAPROXEN SODIUM 220 mg/1 N 20181231 53185-005_5784f8e1-711b-a06b-e053-2991aa0a2413 53185-005 HUMAN OTC DRUG Clear Choice Regular Strength Pain Reliever ACETAMINOPHEN TABLET ORAL 20130603 OTC MONOGRAPH NOT FINAL part343 Athlete's Needs Inc ACETAMINOPHEN 325 mg/1 N 20181231 53185-249_40cb757b-421e-4c40-b7b6-e216a3a824d1 53185-249 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH NOT FINAL part343 Athlete's Needs Inc ASPIRIN 325 mg/1 N 20181231 53185-277_157db3a7-f860-404a-9d7b-332ac05baf32 53185-277 HUMAN OTC DRUG Chlorpheniramine maleate 4mg Chlorpheniramine maleate 4mg TABLET, COATED ORAL 20141215 OTC MONOGRAPH FINAL part341 Athlete's Needs, Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 53185-362_bfaca511-d077-470f-b69b-69e3e49bd3a4 53185-362 HUMAN OTC DRUG Naproxen Sodium 220mg Naproxen Sodium 220mg TABLET, COATED ORAL 20141223 ANDA ANDA090545 Athlete's Needs, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 53185-381_b2286537-9069-4f73-957a-a741ebd9c677 53185-381 HUMAN OTC DRUG Ibuprofen 200mg Ibuprofen 200mg TABLET, COATED ORAL 20161007 ANDA ANDA202312 Athlete's Needs, Inc. IBUPROFEN 200 mg/1 N 20181231 53187-129_08e45495-a0c1-4587-8bbd-f4232bc8c7f0 53187-129 HUMAN OTC DRUG All Day Allergy Cetirizine HCl TABLET ORAL 20111123 ANDA ANDA078780 LIVE BETTER (The Great Atlantic & Pacific Tea Company) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 53187-189_30bdf288-c933-4867-9929-ef702c97ef9d 53187-189 HUMAN OTC DRUG 24 Hour Allergy Fexofenadine HCl TABLET ORAL 20130320 ANDA ANDA079112 LIVE BETTER (The Great Atlantic & Pacific Tea Company) FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 53187-199_5ddba052-b2f4-4556-8fe0-921505d75085 53187-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130325 ANDA ANDA078682 LIVE BETTER (The Great Atlantic & Pacific Tea Company) IBUPROFEN 200 mg/1 N 20181231 53187-220_521a2311-5b96-443e-aef1-b2f406eafb6b 53187-220 HUMAN OTC DRUG All Day Allergy Cetirizine HCl TABLET ORAL 20130607 ANDA ANDA078427 LIVE BETTER (The Great Atlantic & Pacific Tea Company) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 53187-230_4c68aa12-2dc2-45f2-b731-6bee6d0d0e16 53187-230 HUMAN OTC DRUG Nighttime Sleep Aid maximum strength Diphenhydramine HCl CAPSULE ORAL 20100726 OTC MONOGRAPH FINAL part341 LIVE BETTER (The Great Atlantic & Pacific Tea Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 53187-236_20e2cdca-40e8-473c-a652-1227111e4c38 53187-236 HUMAN OTC DRUG NightTime Sleep Aid Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 LIVE BETTER (The Great Atlantic & Pacific Tea Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 53187-238_0f74d5fe-ae47-433c-a5cf-c94b18c0954e 53187-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130830 OTC MONOGRAPH NOT FINAL part334 LIVE BETTER (The Great Atlantic & Pacific Tea Company) DOCUSATE SODIUM 100 mg/1 N 20181231 53187-242_bea2b147-b851-4c6d-b80f-28713e8070c7 53187-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH FINAL part347 LIVE BETTER (The Great Atlantic & Pacific Tea Company) DIMETHICONE 125 mg/1 N 20181231 53187-470_fb4c9976-2fb2-4b6b-a350-f4ea77ec4d22 53187-470 HUMAN OTC DRUG Daytime Cold and Flu relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130105 OTC MONOGRAPH FINAL part341 LIVE BETTER (The Great Atlantic & Pacific Tea Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 53187-480_27302234-335b-4e72-9dbc-9d4f814ddb40 53187-480 HUMAN OTC DRUG Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH FINAL part341 LIVE BETTER (The Great Atlantic & Pacific Tea Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 53187-530_dcff1462-4615-46d6-9e32-b632b3679f6a 53187-530 HUMAN OTC DRUG Gas Relief ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20100817 OTC MONOGRAPH FINAL part332 LIVE BETTER (The Great Atlantic & Pacific Tea Company) DIMETHICONE 180 mg/1 N 20181231 53187-670_1e41cac5-2593-45a6-af3c-b69a61e2f15a 53187-670 HUMAN OTC DRUG Nasal Decongestant Maximum Strength Phenylephrine HCl TABLET ORAL 20140331 OTC MONOGRAPH FINAL part341 LIVE BETTER (The Great Atlantic & Pacific Tea Company) PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 53199-100_e3960e55-019c-4f2e-b527-03e933699413 53199-100 HUMAN PRESCRIPTION DRUG Southern Medical Oxygen, Compressed Compressed Oxygen GAS RESPIRATORY (INHALATION) 20100108 NDA NDA205849 Michael R. Mullins II Inc. dba Southern Medical OXYGEN 1 L/L N 20181231 53200-001_a5d9e551-6401-4b22-b7fc-92031b40c295 53200-001 HUMAN PRESCRIPTION DRUG Derma Numb Lidocaine HCI SPRAY TOPICAL 20120715 OTC MONOGRAPH FINAL part348 Atlas Tat Inc. LIDOCAINE HYDROCHLORIDE 40 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 53203-101_0aafc926-a871-4a89-b952-ee6fdba2bc1f 53203-101 HUMAN OTC DRUG HERBAL HEAT PAIN RELIEVING PATCH PATCH TOPICAL 20130131 OTC MONOGRAPH NOT FINAL part348 Eu Yan Sang (USA) Inc CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 1; 6; 2 g/100g; g/100g; g/100g E 20171231 53208-000_60ef9d05-55a8-6441-e053-2a91aa0ae023 53208-000 HUMAN OTC DRUG ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA TITANIUM DIOXIDE CREAM TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE 121.6 mg/g N 20181231 53208-001_618f700d-0386-5f8b-e053-2a91aa0ac8fd 53208-001 HUMAN OTC DRUG O HUI Sun Science Ideal Cover Sunscreen Broad Spectrum TITANIUM DIOXIDE CREAM TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE 121.6 mg/g N 20181231 53208-002_60ef9d05-55b9-6441-e053-2a91aa0ae023 53208-002 HUMAN OTC DRUG ISA KNOX 365 SUNSCREEN BROAD SPECTRUM SPF 50 Plus HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20141028 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 100; 50; 30; 26 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53208-372_19e255cc-cf02-465b-9b81-d08787c21ab8 53208-372 HUMAN OTC DRUG GONGJINHYANG SEOL WHITENING DIOSMETIN CREAM TOPICAL 20100324 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. DIOSMETIN .1 g/100g E 20171231 53208-374_447ddb2a-e161-48b5-a894-48e49790d982 53208-374 HUMAN OTC DRUG Gongjinhyang Seol Whitening Intensive DIACETYL BENZOYL LATHYROL CREAM TOPICAL 20100326 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. DIACETYL BENZOYL LATHYROL .1 mL/100mL E 20171231 53208-377_faa27470-f1a4-461b-b2ae-4ae04a2f271a 53208-377 HUMAN OTC DRUG GONGJINHYANG SEOL WHITENING JINAEK PROGRAM DIACETYL BENZOYL LATHYROL CREAM TOPICAL 20100329 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. DIACETYL BENZOYL LATHYROL .1 mL/100mL E 20171231 53208-385_33a6f73b-4cc8-407a-8cf1-f07403a3284a 53208-385 HUMAN OTC DRUG ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION ARBUTIN LOTION TOPICAL 20100329 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. ARBUTIN 2.1 g/100g E 20171231 53208-393_64ed9efb-7b75-44e8-bbd2-b44e6e078194 53208-393 HUMAN OTC DRUG ISAKNOX SUNCARE 365 ADVANCED SUN ZINC OXIDE, OCTINOXATE, SULFURIC ACID CREAM TOPICAL 20100330 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 11; 7; 1 mL/100mL; mL/100mL; mL/100mL E 20171231 53208-410_24c090dd-d82e-4659-b823-0392e3aac691 53208-410 HUMAN OTC DRUG GONGJINHYANG MI LUXURY FOUNDATION 2 OCTINOXATE, HYDROXYPROLINE CREAM TOPICAL 20100330 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. HYDROXYPROLINE; OCTINOXATE .53; 1 mL/100mL; mL/100mL E 20171231 53208-414_eb468f28-0e53-4414-b5a2-565b9063b5a8 53208-414 HUMAN OTC DRUG ISA KNOX WHITE SYMPHONY AMPULE ESSENCE ATRACTYLODES JAPONICA ROOT CREAM TOPICAL 20100524 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. ATRACTYLODES JAPONICA ROOT .0525 mL/100mL E 20171231 53208-418_cae59fd9-dd1f-42e9-bf32-b65731cb932b 53208-418 HUMAN OTC DRUG Sooryehan Dabityoon Jiyoon Two way cake 23 Titanium Dioxide, OCTINOXATE POWDER TOPICAL 20100330 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE 3.5; 14 g/100g; g/100g E 20171231 53208-424_6e64ea12-51fb-48c5-ac2f-90142bf2ba20 53208-424 HUMAN OTC DRUG ISA KNOX WXII PLUS WHITENING REVOLUTION SERUM DIOSMETIN CREAM TOPICAL 20100423 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. DIOSMETIN .11 mL/100mL E 20171231 53208-427_e282a217-b834-497f-9c47-2da287e024b9 53208-427 HUMAN OTC DRUG Whoo Gongjinhyang Seol Whitening Jin Essence DIOSMETIN CREAM TOPICAL 20100524 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. DIOSMETIN .055 mL/100mL E 20171231 53208-428_65b4e93e-d520-4a32-a8a2-578c80a98349 53208-428 HUMAN OTC DRUG WHOO GONGJINHYANG SEOL WHITENING JINAEK PROGRAM KIT TITANIUM DIOXIDE CREAM TOPICAL 20100414 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. TITANIUM DIOXIDE .5 mL/100mL E 20171231 53208-429_491d528b-81e8-4510-9d7a-92036789b2c3 53208-429 HUMAN OTC DRUG OHUI Wrinkle Science wrinkle repair eye HYDROXYPROLINE CREAM TOPICAL 20100416 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. HYDROXYPROLINE .51 1/100mL E 20171231 53208-430_df8ba716-4e38-451b-b6ae-b87cb8c070fd 53208-430 HUMAN OTC DRUG O HUI WRINKLE SCIENCE WRINKLE REPAIR HYDROXYPROLINE CREAM TOPICAL 20100416 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. HYDROXYPROLINE .5 1/100mL E 20171231 53208-437_91fec625-4ddf-4570-8190-f75d77d1ea02 53208-437 HUMAN OTC DRUG OHUI Sun Science Powder Sun Block Natural Skin OCTINOXATE, Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20100416 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE; BISOCTRIZOLE 7; 5; 2.5; 2 g/100g; g/100g; g/100g; g/100g E 20171231 53208-441_9501a469-2860-4638-8c61-9b05d75ba853 53208-441 HUMAN OTC DRUG Sooryehan Pure-Whitening Polydatin CREAM TOPICAL 20100426 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. POLYDATIN .22 mL/100mL E 20171231 53208-442_96b56a25-5672-4dab-b4dd-41043268fc97 53208-442 HUMAN OTC DRUG Sooryehan Pure-Whitening Essence POLYDATIN CREAM TOPICAL 20100514 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. POLYDATIN .22 1/100mL E 20171231 53208-444_3f1a7eb9-ed5c-433c-89f1-2b44cd73866a 53208-444 HUMAN OTC DRUG Sooryehan Pure Whitening Spot Treatment POLYDATIN CREAM TOPICAL 20100426 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. POLYDATIN .21 mL/100mL E 20171231 53208-445_5aa029cd-c6b4-422c-a8af-8b912a261df0 53208-445 HUMAN OTC DRUG Sooryehan Pure-Whitening Essential Starter ARBUTIN CREAM TOPICAL 20100428 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. ARBUTIN 2.1 mL/100mL E 20171231 53208-446_21977c7e-dbed-4069-aee8-8ef54f827924 53208-446 HUMAN OTC DRUG Sooryehan Jadan Sun Mild OCTOCRYLENE, ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part358 LG Household and Healthcare, Inc. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE; OCTOCRYLENE 5.612; 7; 2; 2 mL/100mL; mL/100mL; mL/100mL; 1/100mL E 20171231 53208-447_5d964551-bd46-42da-be85-faeaa6c1ad8c 53208-447 HUMAN OTC DRUG Sooryehan Bichaek Jadan Sun ZINC OXIDE, TITANIUM DIOXIDE, PHENYLBENZIMIDAZOLE SULFONIC ACID CREAM TOPICAL 20100524 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ZINC OXIDE; TITANIUM DIOXIDE; ENSULIZOLE 12.88; 4.32; 3.9 1/100mL; mL/100mL; mL/100mL E 20171231 53208-448_953a9f75-39fb-4fa2-8ca0-81324ebbbfb9 53208-448 HUMAN OTC DRUG Perioe lucky fresh - cavity care Sodium Monofluorophosphate, Pyridoxine Hydrochloride, Calcium Glycerophosphate PASTE DENTAL 20100426 OTC MONOGRAPH NOT FINAL part355 LG Household and Healthcare, Inc. SODIUM MONOFLUOROPHOSPHATE; PYRIDOXINE HYDROCHLORIDE; CALCIUM GLYCEROPHOSPHATE .76; .03; .13 g/100g; g/100g; g/100g E 20171231 53208-449_d6f74226-da81-4754-9664-c2375b8cda1f 53208-449 HUMAN OTC DRUG Perioe lucky fresh - breath care Sodium Monofluorophosphate, Calcium Glycerophosphate PASTE DENTAL 20100428 OTC MONOGRAPH NOT FINAL part355 LG Household and Healthcare, Inc. CALCIUM GLYCEROPHOSPHATE; SODIUM MONOFLUOROPHOSPHATE .13; .76 g/100g; g/100g E 20171231 53208-452_3f7ab5b9-1059-4c3d-88c2-303d093a6e67 53208-452 HUMAN OTC DRUG THE HISTORY OF WHOO GONG JIN HYANG HAE YOON SUN OCTINOXATE, BEMOTRIZINOL CREAM TOPICAL 20100430 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. BEMOTRIZINOL; OCTINOXATE .8; 7 mL/100mL; mL/100mL E 20171231 53208-459_08d50681-3c1a-4537-8478-60dae3839931 53208-459 HUMAN OTC DRUG BAMBOO SALT Eunganggo Jook Yeom Toothpaste SILICON DIOXIDE , SODIUM FLUORIDE, AMINOCAPROIC ACID, GLYCYRRHIZINATE DIPOTASSIUM, Curcuma xanthorrhiza oil, SEA SALT PASTE DENTAL 20100525 OTC MONOGRAPH NOT FINAL part355 LG Household and Healthcare, Inc. SILICON DIOXIDE; SODIUM FLUORIDE; AMINOCAPROIC ACID; GLYCYRRHIZINATE DIPOTASSIUM; URSODIOL; CURCUMA XANTHORRHIZA OIL; SEA SALT 20; .22; .05; .04; .02; .025; 3 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 53208-460_1a793cd5-c190-496c-b960-68ede4d8bb46 53208-460 HUMAN OTC DRUG Gongjinhyang Qi and Jin Eye ANGELICA DAHURICA ROOT CREAM TOPICAL 20100524 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. ANGELICA DAHURICA ROOT .022 mL/100mL E 20171231 53208-471_89bc51f1-b63c-4058-b0e4-65cdec67f4a0 53208-471 HUMAN OTC DRUG ISA KNOX AGELESS SERUM MAKEUP BASE 10 OCTINOXATE, TITANIUM DIOXIDE, DIMETHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, HYDROXYPROLINE, CREAM TOPICAL 20100704 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE; DIMETHICONE; ALUMINUM HYDROXIDE; STEARIC ACID; HYDROXYPROLINE 3; 3.38; .08; .18; .18; .53 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 53208-473_65e4ff81-62b4-42c6-98d9-76ff1d742cf4 53208-473 HUMAN OTC DRUG OHUI Sun Science intensive sunblock cake EX ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, BEMOTRIZINOL CREAM TOPICAL 20100716 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE; BEMOTRIZINOL 10.528; 7; 4; 1.5 g/100g; g/100g; g/100g; g/100g E 20171231 53208-475_67a7c69f-83e8-4e31-a1a2-a310de75dac4 53208-475 HUMAN OTC DRUG ISAKNOX AGELESS SERUM BLEMISH BALM TITANIUM DIOXIDE, OCTYLTRIETHOXYSILANE, ALUMINUM HYDROXIDE, OCTINOXATE, ATRACTYLOIDES JAPONICA ROOT OIL CREAM TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE; OCTYLTRIETHOXYSILANE; ALUMINUM HYDROXIDE; ATRACTYLODES JAPONICA ROOT; OCTINOXATE 5.76; .12; .12; .05; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 53208-478_032aedf3-c7a9-40aa-8575-4c31c0d515f9 53208-478 HUMAN OTC DRUG ISAKNOX AGELESS SERUM MOIST PEARL BASE OCTINOXATE, TITANIUM DIOXIDE, DIMETHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, HYDROXYPROLINE, LIQUID TOPICAL 20100831 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE; DIMETHICONE; ALUMINUM HYDROXIDE; STEARIC ACID; HYDROXYPROLINE 3; 3.38; .08; .18; .18; .53 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 53208-480_9fdaef16-0160-44b9-b7f2-4a84d6e1736b 53208-480 HUMAN OTC DRUG ISAKNOX AGELESS SERUM COMPACT 23 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE; OCTINOXATE 4.9; 2 g/100g; g/100g E 20171231 53208-491_3810c629-0d1c-4fdc-8b3e-8a59e779a029 53208-491 HUMAN OTC DRUG OUHI CELL POWER NO 1 ESSENCE NIACINAMIDE, HYDROXYPROLINE LIQUID TOPICAL 20101203 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. NIACINAMIDE; HYDROXYPROLINE 2; .5 mL/100mL; mL/100mL E 20171231 53208-494_c31af57f-062b-4c43-a574-3bf1dd02f48e 53208-494 HUMAN OTC DRUG OHUI SUN SCIENCE PERFECT SUNBLOCK RED EX ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20100716 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ZINC OXIDE; TITANIUM DIOXIDE 13.34; 7 mL/100mL; mL/100mL E 20171231 53208-500_73e50476-5db8-4a12-9a76-47e0d5b9caa8 53208-500 HUMAN OTC DRUG Gongjinhyang Qi and Jin Eye .GAMMA.-AMINOBUTYRIC ACID CREAM TOPICAL 20100524 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. .GAMMA.-AMINOBUTYRIC ACID .022 mL/100mL E 20171231 53208-501_a9487cb0-296c-4e6b-bf00-8fa582917adf 53208-501 HUMAN OTC DRUG O HUI WHITE EXTREME CELLIGHT PROTOCATECHUALDEHYDE EMULSION TOPICAL 20110307 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. PROTOCATECHUALDEHYDE .0315 mL/100mL E 20171231 53208-502_2bda68ca-7ba8-45b6-807f-e1d4d22f1f50 53208-502 HUMAN OTC DRUG ISA KNOX 365 SUN ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20100330 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 11.04; 7.2; 4.03 mL/100mL; mL/100mL; mL/100mL E 20171231 53208-503_00ee8934-f667-44e3-b805-ceaf9f258908 53208-503 HUMAN OTC DRUG The History of Whoo Jin Hae Yoon Sun OCTINOXATE, TITANIUM DIOXIDE, AMILOXATE, BEMOTRIZINOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, ENSULIZOLE CREAM TOPICAL 20110316 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. BEMOTRIZINOL; OCTINOXATE; TITANIUM DIOXIDE; AMILOXATE; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE 1; 7; 2.58; 1.6; 1 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 53208-504_e5e7bab2-698d-413d-b93e-33cc39d5872a 53208-504 HUMAN OTC DRUG GONGJINHYANG SEOL WHITENING ATRACTYLODES JAPONICA ROOT OIL CREAM TOPICAL 20110315 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. ATRACTYLODES JAPONICA ROOT OIL .05 mL/100mL E 20171231 53208-505_4c084d2d-f59d-44d8-8e61-987001b63633 53208-505 HUMAN OTC DRUG BAMBOO SALT Eunganggo Jook Yeom SILICON DIOXIDE , SODIUM FLUORIDE, AMINOCAPROIC ACID, GLYCYRRHIZINATE DIPOTASSIUM, Curcuma xanthorrhiza oil, SEA SALT PASTE DENTAL 20110315 OTC MONOGRAPH NOT FINAL part355 LG Household and Healthcare, Inc. SILICON DIOXIDE; SODIUM FLUORIDE; AMINOCAPROIC ACID; GLYCYRRHIZINATE DIPOTASSIUM; URSODIOL; CURCUMA XANTHORRHIZA OIL; SEA SALT 20; .22; .05; .04; .02; .025; 3 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 53208-507_a9d5e1c7-8dfe-45c1-97cb-26b8a34bbcd3 53208-507 HUMAN OTC DRUG O HUI WHITE EXTREME CELLIGHT PROTOCATECHUALDEHYDE CREAM TOPICAL 20110316 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. PROTOCATECHUALDEHYDE .032 mL/100mL E 20171231 53208-513_cf8060a0-432c-488a-b0b5-6d2336421c37 53208-513 HUMAN OTC DRUG Whoo Gong Jin Hyang Jin Hae Yoon Sun BISOCTRIZOLE, OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE; BISOCTRIZOLE 7.2; 4.8; 2.125; 2.125 g/100g; g/100g; g/100g; g/100g E 20171231 53208-515_2b38f356-c9a4-4ebc-9034-bc6de1f11edc 53208-515 HUMAN OTC DRUG OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE CREAM TOPICAL 20110406 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; ENSULIZOLE; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; HYDROXYPROLINE 7; 6; 4.8; 3.9; .5; .5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 53208-516_10794c21-542e-479a-8266-64cdae9dc30d 53208-516 HUMAN OTC DRUG ReEn Hairloss Clinic Jahajin Shampoo for Sensitive Scalp PYRITHIONE ZINC, PANTHENOL, NIACINAMIDE LIQUID TOPICAL 20110402 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. PYRITHIONE ZINC; NIACINAMIDE; PANTHENOL 1; .1; .2 mL/100mL; mL/100mL; mL/100mL E 20171231 53208-518_2c7b1f69-5b49-44a9-90a8-0f3552e75c32 53208-518 HUMAN OTC DRUG OHUI SUNSCIENCE LUMINOUS WHITENING SUNBLOCK ENSULIZOLE, OCTISALATE, BEMOTRIZINOL, OCTOCRYLENE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, ZINC OXIDE, TITANIUM DIOXIDE, ATRACTYLODES JAPONICA ROOT OIL CREAM TOPICAL 20110406 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ENSULIZOLE; OCTISALATE; BEMOTRIZINOL; OCTOCRYLENE; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; ZINC OXIDE; TITANIUM DIOXIDE; ATRACTYLODES JAPONICA ROOT OIL 3.9; 4.7; 1.5; 5; 1; 12.3; 3.67; .525 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 53208-519_2001a873-4b20-40b8-9227-38ae7e483bd8 53208-519 HUMAN OTC DRUG ISA KNOX AGELESS MOIST SERUM TWO WAY CAKE 21 (REFILL) TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20110412 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE; OCTINOXATE 13.38; 4 g/100g; g/100g E 20171231 53208-520_216c9add-5ee7-494d-b2d2-00bf91e66cc5 53208-520 HUMAN OTC DRUG ISA KNOX SMART BB SUN OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, HYDROXYPROLINE, ATRACTYLODES JAPONICA ROOT OIL CREAM TOPICAL 20110412 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE; HYDROXYPROLINE; ATRACTYLODES JAPONICA ROOT OIL 7; 6.72; 2.88; .5; .05 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 53208-521_12c77838-1965-4074-aa22-f255bfc8aec4 53208-521 HUMAN OTC DRUG ISA KNOX AGELESS MOIST SERUM TWO WAY CAKE 23 (REFILL) TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20110414 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE; OCTINOXATE 13.38; 4 g/100g; g/100g E 20171231 53208-524_ac4cc8c4-fa77-431c-b13a-02b424572f06 53208-524 HUMAN OTC DRUG OHUI Sun Science Sun Block EX plus Beige TALC, OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE, ARBUTIN, ATRACTYLODES JAPONICA ROOT OIL POWDER TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TALC; OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE; ARBUTIN; ATRACTYLODES JAPONICA ROOT OIL 55.493; 7.2; 5.76; 2.59956; 2; .1 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 53208-525_aae58d31-6547-4887-a0b9-7e6b3597aaba 53208-525 HUMAN OTC DRUG THE HISTORY OF WHOO GONGJINHYANG SEOL WHITENING SUN ZINC OXIDE, ENSULIZOLE, POLYSILICONE-15, TITANIUM DIOXIDE, ATRACTYLODES JAPONICA ROOT OIL CREAM TOPICAL 20110524 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ZINC OXIDE; ENSULIZOLE; TITANIUM DIOXIDE; ATRACTYLODES JAPONICA ROOT OIL; POLYSILICONE-15 6.117; 3.9; 2.48; .05; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 53208-528_1978fc3b-df4e-4287-8e6b-70a7438a43d4 53208-528 HUMAN OTC DRUG CATHYCAT ESSENCE SUN BB Titanium Dioxide, OCTINOXATE, Zinc Oxide, AMILOXATE LIQUID TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE; AMILOXATE 13.76176; 7; 3.92; 1 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 53208-530_ce1366cf-01c4-4e87-87b4-b2767a6a0c0a 53208-530 HUMAN OTC DRUG ISAKNOX TERVINA LUMIERE WHITE METHYL UNDECENOYL LEUCINATE CREAM TOPICAL 20110525 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. METHYL UNDECENOYL LEUCINATE .1 mL/100mL E 20171231 53208-531_53f6cd07-a734-4ea2-a512-fcbc28746796 53208-531 HUMAN OTC DRUG ISAKNOX X202 WHITENING SECRET ESSENCE DIOSMETIN CREAM TOPICAL 20110601 UNAPPROVED DRUG OTHER LG Household and Healthcare, Inc. DIOSMETIN .055 mL/100mL E 20171231 53208-533_68a74fbc-b6d6-40b7-9f53-095fed7e1fe4 53208-533 HUMAN OTC DRUG OHUI White Extreme Illuminating Pact No.10 TITANIUM DIOXIDE, OCTINOXATE, ARBUTIN, ATRACTYLODES JAPONICA ROOT OIL POWDER TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE; OCTINOXATE; ARBUTIN; ATRACTYLODES JAPONICA ROOT OIL 9.84; 4.5; 2; .1 g/100g; g/100g; g/100g; g/100g E 20171231 53208-534_6c06b338-5bcc-4743-a8a2-646827541f11 53208-534 HUMAN OTC DRUG OHUI White Extreme Illuminating Pact No.10 TITANIUM DIOXIDE, OCTINOXATE, ARBUTIN, ATRACTYLODES JAPONICA ROOT OIL POWDER TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE; OCTINOXATE; ARBUTIN; ATRACTYLODES JAPONICA ROOT OIL 9.84; 4.5; 2; .1 g/100g; g/100g; g/100g; g/100g E 20171231 53208-538_493b4e2c-9c76-4ee0-a7c6-83406607b171 53208-538 HUMAN OTC DRUG OHUI SUN SCIENCE Perfect Sunblock black EX plus ZINC OXIDE, TITANIUM DIOXIDE, ENSULIZOLE CREAM TOPICAL 20110803 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. ZINC OXIDE; TITANIUM DIOXIDE; ENSULIZOLE 22.7; 10; 3.9 mL/100mL; mL/100mL; mL/100mL E 20171231 53208-539_5563affb-146e-4f66-b499-596dcf74e74f 53208-539 HUMAN OTC DRUG OHUI SUN SCIENCE Perfect Sunblock Blue EX plus TITANIUM DIOXIDE, OCTOCRYLENE, POLYSILICONE-15, OCTISALATE, ENSULIZOLE, BEMOTRIZINOL CREAM TOPICAL 20110803 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE; POLYSILICONE-15; OCTISALATE; ENSULIZOLE; BEMOTRIZINOL 9; 5; 4.8; 3.9; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 53208-541_adeb0651-a126-4e8e-bda2-54927459d41c 53208-541 HUMAN OTC DRUG SOORYEHAN ONBIT ESSENCE FOUNDATION 21 OCTINOXATE, TITANIUM DIOXIDE, ALUMINUM HYDROXIDE, STEARIC ACID, HYDROXYPROLINE CREAM TOPICAL 20110825 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE; ALUMINUM HYDROXIDE; STEARIC ACID; HYDROXYPROLINE 3; .8; .1; .1; .5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 53208-545_a597aa2e-ca1f-4784-ab6d-e264410ed91c 53208-545 HUMAN OTC DRUG Soorhyehan Onbit Two Way Cake 23 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20110825 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE; OCTINOXATE 5.88; 4 g/100g; g/100g E 20171231 53208-549_b6962d6b-f69c-4375-8bdc-4c1a1853552b 53208-549 HUMAN OTC DRUG SOORYEHAN HYO FERMENTED SUN BLOCK ZINC OXIDE, TITANIUM DIOXIDE, ENSULIZOLE CREAM TOPICAL 20110927 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. OCTINOXATE; TITANIUM DIOXIDE; AMILOXATE; BEMOTRIZINOL; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; ENSULIZOLE; TROMETHAMINE 7; 2.52; 1.6; 1; 1; 3.9; 2.63 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 53208-550_66bd13bf-1cc9-4be3-9293-20e72e3c6595 53208-550 HUMAN OTC DRUG OHUI AGE RECOVERY TRI SHIELD PACT 10 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20111011 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE; OCTINOXATE 4.9; 2 g/100g; g/100g E 20171231 53208-551_bffe4087-0880-49cd-959a-203af5015cc1 53208-551 HUMAN OTC DRUG OH Age recovery Tri Shield pact 10 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20110927 OTC MONOGRAPH NOT FINAL part352 LG Household and Healthcare, Inc. TITANIUM DIOXIDE; OCTINOXATE 4.9; 2 g/100g; g/100g E 20171231 53208-600_2be8ac25-6a4c-0b03-e054-00144ff8d46c 53208-600 HUMAN OTC DRUG OHUI Ultimate Cover CC Cushion Compact 01 Light Beige Titanium Dioxide POWDER TOPICAL 20160125 OTC MONOGRAPH NOT FINAL part352 LG Household and Health Care Inc ENSULIZOLE; TITANIUM DIOXIDE .405; .819 g/15g; g/15g N 20191231 53208-601_2aba1923-649e-2520-e054-00144ff8d46c 53208-601 HUMAN OTC DRUG OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige Titanium Dioxide POWDER TOPICAL 20160125 OTC MONOGRAPH NOT FINAL part352 LG Household and Health Care Inc TITANIUM DIOXIDE; ENSULIZOLE .819; .405 g/15g; g/15g N 20191231 53208-602_2be8f533-abac-2292-e054-00144ff8d46c 53208-602 HUMAN OTC DRUG OHUI Powdery Metal Cushion Compact 01 Light Beige Titanium Dioxide POWDER TOPICAL 20160125 OTC MONOGRAPH NOT FINAL part352 LG Household and Health Care Inc TITANIUM DIOXIDE; ENSULIZOLE; OCTINOXATE; ZINC OXIDE 1.077; .405; 1.05; .436 g/15g; g/15g; g/15g; g/15g N 20191231 53208-603_2be8e08f-d3de-3083-e054-00144ff88e88 53208-603 HUMAN OTC DRUG OHUI Powdery Metal Cushion Compact 02 Natural Beige Titanium Dioxide POWDER TOPICAL 20160125 OTC MONOGRAPH NOT FINAL part352 LG Household and Health Care Inc TITANIUM DIOXIDE; ENSULIZOLE; OCTINOXATE; ZINC OXIDE 1.077; .405; 1.05; .436 g/15g; g/15g; g/15g; g/15g N 20191231 53208-604_52ff4754-d5ef-3297-e054-00144ff88e88 53208-604 HUMAN OTC DRUG O HUI Perfect Sun Black EX Broad Spectrum SPF 50 Ensulizole, Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 LG Household and Health Care Inc TITANIUM DIOXIDE; ENSULIZOLE; OCTINOXATE; OCTISALATE; ZINC OXIDE 2.2; 1.75; 3.5; 2.25; 4.86 g/50g; g/50g; g/50g; g/50g; g/50g N 20181231 53208-700_4f434cbc-3121-6554-e054-00144ff88e88 53208-700 HUMAN OTC DRUG belif Moisturizing bomb cushion compact - light beige Ensulizole, Titanium Dioxide POWDER TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 LG Household and Health Care Inc TITANIUM DIOXIDE; ENSULIZOLE .819; .405 g/15g; g/15g N 20181231 53208-701_52ef4cfc-f117-0dbb-e054-00144ff88e88 53208-701 HUMAN OTC DRUG belif Moisturizing bomb cushion compact - natural beige Ensulizole, Titanium Dioxide POWDER TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 LG Household and Health Care Inc TITANIUM DIOXIDE; ENSULIZOLE .819; .405 g/15g; g/15g N 20181231 53210-1001_8bc77776-7313-4c74-88b0-8122b1d7df33 53210-1001 HUMAN OTC DRUG Tolnaftate TOLNAFTATE CREAM TOPICAL 20120925 OTC MONOGRAPH FINAL part333C Morales Distributors, Inc. TOLNAFTATE 1 g/100g E 20171231 53210-1002_71b8d41c-4468-448a-8cb6-5f03b0852596 53210-1002 HUMAN OTC DRUG Hydrocortisone HYDROCORTISONE CREAM TOPICAL 20120925 OTC MONOGRAPH NOT FINAL part348 Morales Distributors Inc HYDROCORTISONE 1 g/100g E 20171231 53210-1003_e90595b3-d065-4c09-afbd-7c3ae3e95bd4 53210-1003 HUMAN OTC DRUG Antibiotic NEOMYCIN SULFATE OINTMENT TOPICAL 20120925 OTC MONOGRAPH FINAL part333B Morales Distributors Inc NEOMYCIN SULFATE 3.5 mg/g E 20171231 53210-1004_3173a08b-5f96-4c1e-8668-9c34360fb55f 53210-1004 HUMAN OTC DRUG Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE OINTMENT TOPICAL 20120926 OTC MONOGRAPH FINAL part333B Morales Distributors Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 U/g; mg/g; U/g E 20171231 53217-001_69b4a3d6-0e03-4e4b-9377-0926bae0faef 53217-001 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 53217-003_d8132b9b-3eb6-4b19-a8cc-4a67712e19d0 53217-003 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328 ANDA ANDA074532 Aidarex Pharmaceuticals LLC CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53217-004_2d60485d-d6e7-47d7-813d-0db3a3214e20 53217-004 HUMAN OTC DRUG New Terocin Methyl Salicylate, Capsaicin, and Menthol LOTION TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Aidarex Pharmaceuticals LLC METHYL SALICYLATE; CAPSAICIN; MENTHOL 25; .025; 10 g/100mL; g/100mL; g/100mL N 20181231 53217-005_8da49cda-f1fa-4227-9892-57f67235f68b 53217-005 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Aidarex Pharmaceuticals LLC DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 53217-006_6947b532-323d-413d-b76d-7ea159b285b7 53217-006 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Aidarex Pharmaceuticals LLC DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 53217-007_de01a1bf-91d5-43b3-b516-dfa6fb5d4316 53217-007 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040788 Aidarex Pharmaceuticals LLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 53217-008_3a79526b-bcfe-4635-82a6-73cafe9b13eb 53217-008 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110201 ANDA ANDA075693 Aidarex Pharmaceuticals LLC IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 53217-009_9be2d0a1-1415-47de-87f0-03a66680c62f 53217-009 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19950703 ANDA ANDA074076 Aidarex Pharmaceuticals LLC LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 53217-010_c8bbdb77-8cb5-437b-96b7-a064ba98c84d 53217-010 HUMAN PRESCRIPTION DRUG NifedicalXL XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20001211 ANDA ANDA075289 Aidarex Pharmaceuticals LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 53217-011_909139f0-c2f9-4004-a245-b38cf54c4869 53217-011 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Aidarex Pharmaceuticals LLC SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 53217-012_8d6a065d-30d4-4b0d-a51e-cc101b8271a8 53217-012 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Aidarex Pharmaceuticals LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53217-014_278d33d3-ae7b-40ec-9ff4-8f6d667e3f50 53217-014 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide CREAM TOPICAL 20060609 ANDA ANDA040671 Aidarex Pharmaceuticals LLC TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 53217-015_60077487-aec7-4042-99ec-6f531bb31fdf 53217-015 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20100119 ANDA ANDA076419 Aidarex Pharmaceuticals LLC KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 53217-018_569f166d-b427-4409-9418-8432052de580 53217-018 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 53217-019_3a77ea51-3169-45d6-ae45-7e2bdaea2347 53217-019 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Aidarex Pharmaceuticals LLC HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 53217-020_3322107f-096e-40f9-96be-bcd71578c47f 53217-020 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20110101 ANDA ANDA040182 Aidarex Pharmaceuticals LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 167 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 53217-021_c7176ee9-dfa5-47e9-b972-17c2273a81ea 53217-021 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin GEL TOPICAL 20080612 ANDA ANDA063211 Aidarex Pharmaceuticals LLC ERYTHROMYCIN 20 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 53217-022_342bbf92-0160-4f92-b1ce-98cedd5fd6d5 53217-022 HUMAN PRESCRIPTION DRUG Nystatin Nystatin OINTMENT TOPICAL 20020903 ANDA ANDA062840 Aidarex Pharmaceuticals LLC NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 53217-024_0b3cb041-1d4b-486d-937b-95e06b0b9882 53217-024 HUMAN OTC DRUG ROBAFEN COUGH FORMULA Guaifenesin SYRUP ORAL 20120815 OTC MONOGRAPH FINAL part341 Aidarex Pharmaceuticals LLC GUAIFENESIN 100 mg/5mL N 20181231 53217-026_bcc54b4f-bf01-40dc-82e3-633f8bb1054a 53217-026 HUMAN OTC DRUG LenzaGel LIDOCAINE HYDROCHLORIDE, MENTHOL GEL TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Aidarex Pharmaceuticals LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g N 20181231 53217-031_6ef123b8-910d-4715-986f-011aa8f4fcc4 53217-031 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20051201 ANDA ANDA065276 Aidarex Pharmaceuticals LLC CEFPROZIL 500 mg/1 N 20181231 53217-040_89d35016-9fee-46c7-8f7d-9168a2ad383a 53217-040 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Aidarex Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 53217-054_7e0d9034-c76b-4349-8443-ababb9db92a3 53217-054 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20100524 ANDA ANDA090216 Aidarex Pharmaceuticals LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 53217-058_c5eb25f0-c650-4cc7-8f2c-60574e93c8fc 53217-058 HUMAN OTC DRUG Bismatrol Bismuth subsalicylate TABLET, CHEWABLE ORAL 20030103 OTC MONOGRAPH FINAL part335 Aidarex Pharmaceuticals LLC BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 53217-060_55591708-1dc9-45bb-8870-12609d4b51c7 53217-060 HUMAN OTC DRUG Bismatrol Bismuth Subsalicylate LIQUID ORAL 20080530 OTC MONOGRAPH FINAL part335 Aidarex Pharmaceuticals LLC BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 53217-063_b50ba291-8672-4722-99a8-73aa624ad39b 53217-063 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20091105 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 53217-064_66c9882a-58ad-4edd-8183-db4352828a50 53217-064 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine GEL TOPICAL 20130301 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC LIDOCAINE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 53217-066_1ffe0c86-333f-4852-9051-3c98411e494d 53217-066 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Aidarex Pharmaceuticals LLC NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 53217-070_9e51fa64-b081-4deb-8f8c-a21836a381d4 53217-070 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20121018 ANDA ANDA070791 Aidarex Pharmaceuticals LLC DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 53217-081_8a6f6dc6-2dc8-454b-bf65-02888cddb0e4 53217-081 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-130_6483fe74-0165-4b79-b14c-ae4881728118 53217-130 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Aidarex Pharmaceuticals LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-132_4aad8c0c-47ef-4049-a27e-0f37acdc6be5 53217-132 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 20061031 ANDA ANDA040620 Aidarex Pharmaceuticals LLC METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 53217-138_7511903e-4f5d-4fc3-8d82-08eca9a9c67b 53217-138 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20151210 ANDA ANDA204431 Aidarex Pharmaceuticals LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 53217-149_eaca04e2-15b7-45a3-9480-1a678ba9c184 53217-149 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 Aidarex Pharmaceuticals LLC ESZOPICLONE 2 mg/1 CIV N 20181231 53217-150_da945963-e887-4560-9951-93ec1552cb45 53217-150 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091166 Aidarex Pharmaceuticals LLC ESZOPICLONE 1 mg/1 CIV N 20181231 53217-151_9ca75b79-bb7f-41a6-91fd-76abb78bb939 53217-151 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Aidarex Pharmaceuticals LLC ESZOPICLONE 3 mg/1 CIV N 20181231 53217-152_8cc17b6d-c863-4b8e-ab32-c6c2b4c35d99 53217-152 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19871101 ANDA ANDA087499 Aidarex Pharmaceuticals LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 53217-153_140ccf92-6551-4966-b536-7505926acd2a 53217-153 HUMAN OTC DRUG LidoPro Capsaicin, Lidocaine, Menthol, and Methyl Salicylate OINTMENT TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Aidarex Pharmaceuticals LLC CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE .000325; .04; .1; .275 g/g; g/g; g/g; g/g N 20181231 53217-154_c814a14d-9200-4a65-bbfb-9da05192d2e0 53217-154 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 Aidarex Pharmaceuticals LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 53217-155_64fce738-5e92-446c-862a-46d0b3700e99 53217-155 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Aidarex Pharmaceuticals LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-156_b1418125-e23b-471e-acae-0295519300a3 53217-156 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Aidarex Pharmaceuticals LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53217-157_b1418125-e23b-471e-acae-0295519300a3 53217-157 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Aidarex Pharmaceuticals LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53217-158_da32a585-096f-4756-88d2-a998dee90ec0 53217-158 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20150601 ANDA ANDA205085 Aidarex Pharmaceuticals LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 53217-159_cb7453c7-06ce-4e74-b494-f71e338e0ed8 53217-159 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 Aidarex Pharmaceuticals LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 53217-161_e93d2a8a-9553-4318-a684-b30487bdf9f7 53217-161 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065223 Aidarex Pharmaceuticals LLC AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 53217-163_9eec1107-0de2-4d44-aba2-3d06952c7ab9 53217-163 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20131203 ANDA ANDA078488 Aidarex Pharmaceuticals LLC CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 53217-164_bc6468db-adb9-4342-ad67-34c18bd6cae0 53217-164 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate CREAM TOPICAL 20060630 ANDA ANDA077055 Aidarex Pharmaceuticals LLC FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 53217-166_7d48c7ff-6157-431e-bde8-8aa48d6de24a 53217-166 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Aidarex Pharmaceuticals LLC ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 53217-167_4886349c-74c3-4fb0-a717-2296020cafe9 53217-167 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 Aidarex Pharmaceuticals LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-169_c44a6c19-77e8-48df-8e42-0b7c5681fa84 53217-169 HUMAN PRESCRIPTION DRUG Fenoprofen Calcium fenoprofen calcium CAPSULE ORAL 20160519 NDA AUTHORIZED GENERIC NDA017604 Aidarex Pharmaceuticals LLC FENOPROFEN CALCIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53217-170_f134ef66-ee3d-4d29-a5d5-849abeadc033 53217-170 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20150325 ANDA ANDA078722 Aidarex Pharmaceuticals LLC CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 53217-171_46e5d39c-90ed-46ae-a35a-55b32c19dce2 53217-171 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20050415 ANDA ANDA040555 Aidarex Pharmaceuticals LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 53217-172_491e087f-cc22-46cf-9407-0509c339fe9c 53217-172 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20130812 ANDA ANDA040526 Aidarex Pharmaceuticals LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 53217-173_fc239fb9-8398-44a7-9eaa-73d6f2a453e6 53217-173 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Aidarex Pharmaceuticals LLC AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 53217-174_e61daff9-c6e3-4251-87a5-8cf3baf678c1 53217-174 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 53217-175_3904530d-83e6-4359-b6a9-63f15b0366f1 53217-175 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride TABLET ORAL 20100907 ANDA ANDA040747 Aidarex Pharmaceuticals LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 53217-177_fa278c8f-3315-46db-933a-1a5c6c6284ff 53217-177 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Aidarex Pharmaceuticals LLC PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-178_e61daff9-c6e3-4251-87a5-8cf3baf678c1 53217-178 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Aidarex Pharmaceuticals LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 53217-179_735a955e-3749-4578-96fe-c5541cc34581 53217-179 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 Aidarex Pharmaceuticals LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 53217-180_635e7ce5-287c-458f-946d-39889fadc64d 53217-180 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20121015 ANDA ANDA090460 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 53217-181_8f3e0e4f-b5c4-4d09-8146-50b20da24371 53217-181 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Aidarex Pharmaceuticals LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 53217-182_53f94619-b9c5-4655-93ef-d5a409557b55 53217-182 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Aidarex Pharmaceuticals LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 53217-183_3a6004e6-835b-4a43-b66e-4b58091fb441 53217-183 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760701 ANDA ANDA084769 Aidarex Pharmaceuticals LLC CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 53217-184_7030384d-e301-4908-b923-e823795e9e80 53217-184 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071321 Aidarex Pharmaceuticals LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 53217-185_7030384d-e301-4908-b923-e823795e9e80 53217-185 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071322 Aidarex Pharmaceuticals LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 53217-187_2ca799ba-56af-4fa6-ac9c-44f736ef1a02 53217-187 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018832 Aidarex Pharmaceuticals LLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 53217-188_6d774336-edd3-4d24-b05c-6a54f44016d3 53217-188 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Aidarex Pharmaceuticals LLC ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 53217-189_0fbaaade-7d41-48a3-8ef2-ef824a321c2d 53217-189 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 Aidarex Pharmaceuticals LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 53217-190_8b5b8721-2499-4599-a23b-5d16dae55e09 53217-190 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Aidarex Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 53217-191_91d353d1-48e3-4b84-8e33-4fac37f52464 53217-191 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20160722 ANDA ANDA077534 Aidarex Pharmaceuticals LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-192_bdefe013-f1c1-4262-9773-cfab52bb5c1f 53217-192 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA040148 Aidarex Pharmaceuticals LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 53217-193_7d392866-ceb6-4c51-a581-27e0fb27c17e 53217-193 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Aidarex Pharmaceuticals LLC PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 53217-194_915aabb9-bf7a-445d-a1e4-ba26bc2436af 53217-194 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-196_9ce08f24-cde6-457e-80ca-6ca5940d290e 53217-196 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 Aidarex Pharmaceuticals LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 53217-197_efa53cd9-4a17-47a6-aea3-3c79dfc17bb8 53217-197 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20060331 ANDA ANDA085025 Aidarex Pharmaceuticals LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 53217-198_71c6953c-6472-4610-a4ea-5f868b2ed3ad 53217-198 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20141126 ANDA ANDA203623 Aidarex Pharmaceuticals LLC SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 53217-199_74cc896f-4abf-4b52-8b7d-068d4ec072da 53217-199 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Aidarex Pharmaceuticals LLC LEVOFLOXACIN 500 mg/1 N 20181231 53217-201_c15d4c91-c662-49c6-ade5-0c7ccdf4d761 53217-201 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 Aidarex Pharmaceuticals LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 53217-202_78f2d3bb-e467-43a1-b038-e8889449a1ed 53217-202 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Aidarex Pharmaceuticals LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53217-203_bdb6766b-dc84-4322-aeca-cf7158c02e3a 53217-203 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Aidarex Pharmaceuticals LLC PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53217-204_864e758f-efa4-4be1-851e-42077483e0ae 53217-204 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20130902 ANDA ANDA078155 Aidarex Pharmaceuticals LLC SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53217-205_8fdf3507-3800-45ee-8074-48b090b4d92c 53217-205 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120628 ANDA ANDA071457 Aidarex Pharmaceuticals LLC TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 53217-206_a86fe478-7d07-4e35-b76f-dd3d8b81ecc1 53217-206 HUMAN PRESCRIPTION DRUG Celecoxib 200 mg CELECOXIB CAPSULE ORAL 20151124 ANDA ANDA204519 Aidarex Pharmaceuticals LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53217-207_406b8415-3355-6913-e054-00144ff88e88 53217-207 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 19900930 ANDA ANDA062702 Aidarex Pharmaceuticals LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 53217-208_325cbb93-9085-4617-8af9-78cde371b471 53217-208 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Aidarex Pharmaceuticals LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 53217-209_c8044251-d8ab-4ae5-aa96-e430ecec94db 53217-209 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Aidarex Pharmaceuticals LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53217-210_97c3a14b-67e2-4e2e-b06c-5f3668162027 53217-210 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Aidarex Pharmaceuticals LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 53217-211_e000ff99-a782-4438-a5d2-98a74b96b03a 53217-211 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20031211 ANDA ANDA076416 Aidarex Pharmaceuticals LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 53217-212_9bce3e50-1bf2-4d35-8edf-00d5784a1622 53217-212 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Aidarex Pharmaceuticals LLC TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 53217-213_a6b12e0d-ea67-40eb-ac77-4aae8132e6bf 53217-213 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 19960426 ANDA ANDA040119 Aidarex Pharmaceuticals LLC ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 53217-215_542bc4f0-6834-4f25-8886-88d926505a2d 53217-215 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Aidarex Pharmaceuticals LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 53217-216_cf46170b-7873-4a42-bdc2-292e1861b5be 53217-216 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Aidarex Pharmaceuticals LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 53217-217_406b8404-2832-558d-e054-00144ff8d46c 53217-217 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Aidarex Pharmaceuticals LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 53217-218_a5d860fb-40d9-422c-b330-0dbe8c018626 53217-218 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-219_08694353-ffba-4b71-91f5-8960085429f7 53217-219 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150505 ANDA ANDA040616 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 53217-220_0591c387-31fe-4573-8e32-fbce745b25dd 53217-220 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20090803 ANDA ANDA065373 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 53217-221_f3f68719-f9c4-43dd-b16b-3f30b05fc190 53217-221 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073516 Aidarex Pharmaceuticals LLC KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53217-222_bd9f145d-155d-4482-86b0-882856ce435f 53217-222 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride JELLY TOPICAL 20150615 ANDA ANDA040837 Aidarex Pharmaceuticals LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 53217-223_862bed88-3e87-4d0b-9775-96ea41eed03d 53217-223 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride JELLY TOPICAL 20150615 ANDA ANDA040837 Aidarex Pharmaceuticals LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 53217-224_c473c5f2-c0e9-4891-a3a0-531ebdb8b8b8 53217-224 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20140414 ANDA ANDA204234 Aidarex Pharmaceuticals LLC DOXYCYCLINE 100 mg/1 N 20181231 53217-225_e2984f05-4901-4976-9a71-f99381471f83 53217-225 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 Aidarex Pharmaceuticals LLC HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 53217-229_a65eb341-e2eb-43fc-94e5-b0b995459f57 53217-229 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20061213 ANDA ANDA064163 Aidarex Pharmaceuticals LLC GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 53217-230_a3a566d3-0f95-4133-ba6d-eb1b8ed73825 53217-230 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride Diethylpropion Hydrochloride TABLET ORAL 20110718 ANDA ANDA200177 Aidarex Pharmaceuticals LLC DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 53217-231_5d41f6a4-d047-4fb9-ba0d-c795c9875f7e 53217-231 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603 ANDA ANDA084613 Aidarex Pharmaceuticals LLC DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 53217-232_2867b2a2-bc97-42ef-b4a7-4c7afc448d67 53217-232 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20070301 ANDA ANDA040702 Aidarex Pharmaceuticals LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 53217-233_f745e1c2-4274-45ae-98ec-a3e7cea386a3 53217-233 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aidarex Pharmaceuticals LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53217-235_19a33bba-2961-4d56-abd4-00e4a99f7df3 53217-235 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150714 ANDA ANDA040616 Aidarex Pharmaceuticals LLC WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 53217-236_7ed7972f-86a0-4d18-a652-b5d954da94ac 53217-236 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 Aidarex Pharmaceuticals LLC HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 53217-237_9819fe19-ff72-41a6-aea3-8af87a8a2c87 53217-237 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950217 ANDA ANDA074056 Aidarex Pharmaceuticals LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 53217-238_a5d860fb-40d9-422c-b330-0dbe8c018626 53217-238 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-239_cf46ce00-c9e1-4dc6-bc2b-03e21126b849 53217-239 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 Aidarex Pharmaceuticals LLC TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 53217-240_a6fe390d-8058-4a31-b19f-a8c04af26f73 53217-240 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20130201 ANDA ANDA203253 Aidarex Pharmaceuticals LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 53217-241_259fd673-2e54-4046-a362-7c186dc8f735 53217-241 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Aidarex Pharmaceuticals LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53217-242_c5bbefe1-3d7f-4687-a8f4-b11782d014c0 53217-242 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Aidarex Pharmaceuticals LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-243_2073b916-8277-4f04-87e0-b1793b4a3ef5 53217-243 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20160722 ANDA ANDA202764 Aidarex Pharmaceuticals LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53217-244_d9d4211b-fc59-4696-807f-67328b067ab6 53217-244 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 19970214 ANDA ANDA064120 Aidarex Pharmaceuticals LLC POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 53217-245_a4260f17-307c-40ac-92cf-18fa8fc753de 53217-245 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-246_a2a640a9-1665-4b82-8564-66e4c69c5171 53217-246 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 Aidarex Pharmaceuticals LLC BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 53217-247_b1c48aa2-56a7-4ef7-bae8-b5a35d0bd68c 53217-247 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 Aidarex Pharmaceuticals LLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 53217-248_38f4064a-9326-4e60-8e51-bad57f3e30ff 53217-248 HUMAN PRESCRIPTION DRUG Lidocaine lidocaine OINTMENT TOPICAL 20160201 ANDA ANDA205318 Aidarex Pharmaceuticals LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 53217-249_4951ef6f-4443-40ae-a4b4-2825ba4dd7b4 53217-249 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 Aidarex Pharmaceuticals LLC AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 53217-250_cd9c6208-53c4-46c5-9009-486ddd92d895 53217-250 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Aidarex Pharmaceuticals LLC GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 53217-251_5c29f1a0-da1b-43cd-9409-218c79d2c17d 53217-251 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20160708 ANDA ANDA077836 Aidarex Pharmaceuticals LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 53217-252_31148e02-1a6a-4ac0-81c9-9913d0afe240 53217-252 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160725 ANDA ANDA206674 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 53217-253_069bd16d-3af5-4385-8843-f079cd0f6e85 53217-253 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130213 ANDA ANDA076063 Aidarex Pharmaceuticals LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53217-254_59579982-ea54-48d8-91a1-a49e65f27a98 53217-254 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Aidarex Pharmaceuticals LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 53217-255_f4a25e15-16e1-4da9-a77b-d3914a067310 53217-255 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Aidarex Pharmaceuticals LLC PREDNISONE 10 mg/1 N 20181231 53217-256_0ed87590-3f22-4add-8f48-805b84f8d76e 53217-256 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 Aidarex Pharmaceuticals LLC HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 53217-257_83c89057-ad1c-4039-9122-faec35cb3958 53217-257 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Aidarex Pharmaceuticals LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-260_8a91200a-ff22-4e06-804d-4f18d355c164 53217-260 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20150414 ANDA ANDA078671 Aidarex Pharmaceuticals LLC NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53217-261_9f0d222c-f87f-486b-b186-b09b1173fc9b 53217-261 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20130923 ANDA ANDA075274 Aidarex Pharmaceuticals LLC NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 53217-262_4560e3d4-7e51-42c7-bd30-46c481a751ea 53217-262 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Aidarex Pharmaceuticals LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53217-263_e93d2a8a-9553-4318-a684-b30487bdf9f7 53217-263 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 Aidarex Pharmaceuticals LLC AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 53217-264_aeb9989c-75ce-4b78-9696-8058de92cdf8 53217-264 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20160222 ANDA ANDA205245 Aidarex Pharmaceuticals LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 53217-265_91bb8d23-6843-49f8-9c83-737cb591e4d3 53217-265 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161130 ANDA ANDA201013 Aidarex Pharmaceuticals LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 53217-266_91bb8d23-6843-49f8-9c83-737cb591e4d3 53217-266 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161130 ANDA ANDA201013 Aidarex Pharmaceuticals LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 53217-267_91bb8d23-6843-49f8-9c83-737cb591e4d3 53217-267 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20161130 ANDA ANDA201013 Aidarex Pharmaceuticals LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 53217-268_8f7996d0-00fe-4d22-bcd0-077f9c1898b4 53217-268 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Aidarex Pharmaceuticals LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53217-269_dcabe216-0131-4b2c-82a7-22de2ce0aeaa 53217-269 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 53217-270_dcac18dc-dd83-44db-9765-b08232845f86 53217-270 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-271_53f94619-b9c5-4655-93ef-d5a409557b55 53217-271 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Aidarex Pharmaceuticals LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 53217-272_cea5e27a-5066-48d1-9a5c-b229cac77465 53217-272 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Aidarex Pharmaceuticals LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53217-273_fa309fa7-1a52-4c72-8bfd-0700712371f9 53217-273 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Aidarex Pharmaceuticals LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 53217-274_48b93744-8bad-46fc-aff5-39197b5ff2bc 53217-274 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20160722 ANDA ANDA079162 Aidarex Pharmaceuticals LLC TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 53217-275_055186c2-cb5b-4f77-9ef2-aa6a7d2b4c76 53217-275 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Aidarex Pharmaceuticals LLC PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53217-276_9c0fa2d3-11b1-4a34-b89a-8a2a9b4bc5ed 53217-276 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Aidarex Pharmaceuticals LLC BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 53217-277_537a3cc8-ccd5-4b04-a5a7-3204b7cd07e2 53217-277 HUMAN PRESCRIPTION DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL 20050621 ANDA ANDA077222 Aidarex Pharmaceuticals LLC FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53217-278_537a3cc8-ccd5-4b04-a5a7-3204b7cd07e2 53217-278 HUMAN PRESCRIPTION DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL 20050621 ANDA ANDA077222 Aidarex Pharmaceuticals LLC FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53217-279_ae5cc052-7891-40e0-921e-ca706fc4877a 53217-279 HUMAN PRESCRIPTION DRUG Bupropion HydrochlorideXL XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081126 ANDA ANDA077715 Aidarex Pharmaceuticals LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 53217-280_b71630b8-6cea-458d-9d81-bc8bd7fcb092 53217-280 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir phosphate CAPSULE ORAL 20161212 ANDA ANDA202595 Aidarex Pharmaceuticals LLC OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 53217-282_bbe4b5f0-5923-4c54-ae1d-953d5eb2da2f 53217-282 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Aidarex Pharmaceuticals LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53217-283_12c3c716-6715-4220-8149-98d1fbc30277 53217-283 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Aidarex Pharmaceuticals LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53217-284_041af629-e2da-4269-b675-7766fc40b51d 53217-284 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Aidarex Pharmaceuticals LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53217-285_cca6f5cd-fac6-413d-81e5-6d8447ec119a 53217-285 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20151001 ANDA ANDA091220 Aidarex Pharmaceuticals LLC GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 53217-286_2829df2c-64eb-486b-bf41-ca3358b14241 53217-286 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 Aidarex Pharmaceuticals LLC AMOXICILLIN; CLAVULANIC ACID 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 53217-287_4774d269-7226-47d4-aa21-11cd3dc2fd1a 53217-287 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20140516 ANDA ANDA090455 Aidarex Pharmaceuticals LLC ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 53217-288_c7b1ded3-fbf3-4047-893e-da0f14b436e6 53217-288 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 Aidarex Pharmaceuticals LLC PREDNISONE 20 mg/1 N 20181231 53217-289_fd06a7c2-f0e0-40d3-9673-44bc0e2ff7bd 53217-289 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin, Polymyxin B Sulfates, Dexamethasone OINTMENT OPHTHALMIC 20140703 ANDA ANDA062938 Aidarex Pharmaceuticals LLC DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 53217-290_4fc367a5-9988-469f-89f5-dc4a746406a9 53217-290 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 19951130 ANDA ANDA064071 Aidarex Pharmaceuticals LLC PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 53217-291_63650fcd-30a6-4083-825e-9a3b6cc4fbb6 53217-291 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Aidarex Pharmaceuticals LLC TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 53217-292_8a284917-12d1-40e3-86e5-cff265df0877 53217-292 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Aidarex Pharmaceuticals LLC PREDNISONE 5 mg/1 N 20181231 53217-293_d7c2ba37-8904-4395-ac23-85d29efefe9c 53217-293 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20151118 ANDA ANDA203963 Aidarex Pharmaceuticals LLC SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 53217-295_6435c10d-3212-426a-95a6-8be7ad65acb2 53217-295 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Aidarex Pharmaceuticals LLC ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53217-296_6435c10d-3212-426a-95a6-8be7ad65acb2 53217-296 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Aidarex Pharmaceuticals LLC ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53217-297_6435c10d-3212-426a-95a6-8be7ad65acb2 53217-297 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Aidarex Pharmaceuticals LLC ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53217-298_446675b3-5cf0-46eb-995a-a854c4a5a183 53217-298 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 Aidarex Pharmaceuticals LLC CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 53217-299_9bc61e1d-38ed-48a9-891d-3eb1490d46bd 53217-299 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 19900930 ANDA ANDA062702 Aidarex Pharmaceuticals LLC CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 53217-300_9063c4fb-7de3-4a1f-8600-aee07e5c0f77 53217-300 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Aidarex Pharmaceuticals LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 53217-301_325e0a60-3a47-422a-a504-b445a426a2c9 53217-301 HUMAN PRESCRIPTION DRUG zonisamide zonisamide CAPSULE ORAL 20160713 ANDA ANDA077869 Aidarex Pharmaceuticals LLC ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 53217-302_1ae3a9d5-4145-4468-a16a-e6db8a87a180 53217-302 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 Aidarex Pharmaceuticals LLC DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 53217-303_61ae0a56-8ad4-4a7f-bf2a-5017e06322e8 53217-303 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Aidarex Pharmaceuticals LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53217-304_c7fd107c-3617-431e-be92-01c5e88a5662 53217-304 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Aidarex Pharmaceuticals LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53217-307_4f0270d8-fdba-4379-893f-0dc9269273e4 53217-307 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, COATED ORAL 20140415 ANDA ANDA091024 Aidarex Pharmaceuticals LLC ESZOPICLONE 2 mg/1 N 20181231 53217-312_9b004e12-2f2e-4f3c-bdff-788630bf0f41 53217-312 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 Aidarex Pharmaceuticals LLC AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 53217-314_9b004e12-2f2e-4f3c-bdff-788630bf0f41 53217-314 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 Aidarex Pharmaceuticals LLC AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 53217-315_c2d24d14-c656-4906-a1e4-9d7fee98b3c5 53217-315 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Aidarex Pharmaceuticals LLC TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 53217-316_eaf4eaa3-a21f-49d5-99da-1b7ee8795b9e 53217-316 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Aidarex Pharmaceuticals LLC AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 53217-317_79b13115-7269-4058-95f3-8403ecdc0d5c 53217-317 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 Aidarex Pharmaceuticals LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 53217-318_fc36fb09-9f95-41c6-9b16-a1ed5094464e 53217-318 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 Aidarex Pharmaceuticals LLC LEVOFLOXACIN 750 mg/1 N 20181231 53217-319_da439ee5-c383-4ada-8899-7ace446a228c 53217-319 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160804 ANDA ANDA205519 Aidarex Pharmaceuticals LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53217-321_65fcb8c2-b214-43c8-a98c-f594c4921af4 53217-321 HUMAN PRESCRIPTION DRUG alendronate sodium alendronate sodium TABLET ORAL 20170501 ANDA ANDA076984 Aidarex Pharmaceuticals LLC ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 53217-960_b0a7bb34-1716-4902-a5cd-6afaf7b41f54 53217-960 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150701 NDA NDA022370 Aidarex Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 53218-001_f7d78925-b307-fd57-1b8c-128808d408c6 53218-001 HUMAN OTC DRUG Total White Brightening Hydroquinone, Ethylhexyl Methoxycinnamate LOTION TOPICAL 20121010 OTC MONOGRAPH NOT FINAL part352 YZY Inc OCTINOXATE; HYDROQUINONE 14.19; 9.46 mg/473mL; mg/473mL E 20171231 53218-002_a1adbdb7-d742-222d-dd33-1d274a198ec1 53218-002 HUMAN OTC DRUG Total White Brightening Hydroquinone, Ethylhexyl Methoxycinnamate CREAM TOPICAL 20121010 OTC MONOGRAPH NOT FINAL part352 YZY Inc OCTINOXATE; HYDROQUINONE 3; 2 g/100g; g/100g E 20171231 53225-1022_60a4e591-eeba-a33c-e053-2a91aa0adf26 53225-1022 HUMAN OTC DRUG LidoPro Capsaicin, Lidocaine, Menthol, and Methyl Salicylate OINTMENT TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Terrain Pharmaceuticals CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE .000325; .04; .1; .275 g/g; g/g; g/g; g/g N 20181231 53225-1023_617ca8c3-3372-582f-e053-2991aa0acc5f 53225-1023 HUMAN OTC DRUG LidoPro Patch Lidocaine, Menthol, and Methyl Salicylate PATCH TOPICAL 20141202 OTC MONOGRAPH NOT FINAL part348 Terrain Pharmaceuticals LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE 4; 5; 4 mg/100mg; mg/100mg; mg/100mg N 20181231 53225-1025_60a4b42c-9040-4f75-e053-2a91aa0a059e 53225-1025 HUMAN PRESCRIPTION DRUG LIDOTHOL LIDOCAINE, MENTHOL PATCH TOPICAL 20150616 UNAPPROVED DRUG OTHER Terrain Pharmaceuticals MENTHOL; LIDOCAINE 5; 4.5 g/1; g/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 53225-1030_60a57013-9406-5921-e053-2991aa0ab4e8 53225-1030 HUMAN OTC DRUG VIVA Patch Camphor, Lidocaine, and Methyl Salicylate PATCH TOPICAL 20160831 OTC MONOGRAPH NOT FINAL part348 Terrain Pharmaceuticals LIDOCAINE; CAMPHOR (NATURAL); METHYL SALICYLATE 2.5; 2; 4 mg/100mg; mg/100mg; mg/100mg N 20181231 53225-1090_617ca8c3-3368-582f-e053-2991aa0acc5f 53225-1090 HUMAN OTC DRUG Mencaine Lidocaine, Menthol PATCH TOPICAL 20170824 OTC MONOGRAPH NOT FINAL part348 Terrain Pharmaceuticals LIDOCAINE; MENTHOL 4.5; 5 mg/100mg; mg/100mg N 20181231 53225-3125_60b83384-30ba-0a5d-e053-2a91aa0ab89a 53225-3125 HUMAN PRESCRIPTION DRUG ReadySharp-A Lidocaine Hydrochloride and Bupivacaine Hydrochloride KIT EPIDURAL; INFILTRATION 20151229 NDA NDA016964 Terrain Pharmaceuticals N 20181231 53225-3230_438c8db3-eb60-1b80-e054-00144ff88e88 53225-3230 HUMAN PRESCRIPTION DRUG ReadySharp-K Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Triamcinolone Acetonide KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20151229 NDA NDA016964 Terrain Pharmaceuticals E 20171231 53225-3335_438c6d58-7b5d-7149-e054-00144ff8d46c 53225-3335 HUMAN PRESCRIPTION DRUG ReadySharp-P40 Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Methylprednisolone Acetate KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20151229 NDA NDA016964 Terrain Pharmaceuticals E 20171231 53225-3440_438c8159-83a1-0609-e054-00144ff88e88 53225-3440 HUMAN PRESCRIPTION DRUG ReadySharp-P80 Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Methylprednisolone Acetate KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20151229 NDA NDA016964 Terrain Pharmaceuticals E 20171231 53225-3600_63b10664-98e5-89a2-e053-2991aa0a256b 53225-3600 HUMAN PRESCRIPTION DRUG ReadySharp Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050708 ANDA ANDA080408 Terrain Pharmaceuticals LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 53225-3605_60a4fc89-f6a2-9b26-e053-2991aa0a898a 53225-3605 HUMAN PRESCRIPTION DRUG ReadySharp Bupivacaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INTRACAUDAL; PERINEURAL 20050816 NDA NDA016964 Terrain Pharmaceuticals BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 53225-3610_60a4e737-d058-a417-e053-2a91aa0a3455 53225-3610 HUMAN PRESCRIPTION DRUG ReadySharp Triamcinolone Triamcinolone Acetonide INJECTION, SOLUTION INTRA-ARTICULAR; INTRAMUSCULAR 20090601 NDA NDA014901 Terrain Pharmaceuticals TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 53225-3650_60a4fc89-f6b9-9b26-e053-2991aa0a898a 53225-3650 HUMAN PRESCRIPTION DRUG ReadySharp MethylPrednisolone 80 METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 19590528 NDA NDA011757 Terrain Pharmaceuticals METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 53225-3655_60a4fa41-befb-7ea4-e053-2991aa0a0cd0 53225-3655 HUMAN PRESCRIPTION DRUG ReadySharp Ketorolac KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970605 ANDA ANDA074802 Terrain Pharmaceuticals KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 53225-3660_60a4fc89-f702-9b26-e053-2991aa0a898a 53225-3660 HUMAN PRESCRIPTION DRUG ReadySharp Dexamethasone Dexamethasone Sodium Phosphate INJECTION INTRAMUSCULAR; INTRAVENOUS 19820907 ANDA ANDA087702 Terrain Pharmaceuticals DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 53225-3665_60a4fde2-a26d-c22b-e053-2a91aa0adc61 53225-3665 HUMAN PRESCRIPTION DRUG ReadySharp Betamethasone Betamethasone Sodium Phosphate and Betamethasone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR 20100428 ANDA ANDA090747 Terrain Pharmaceuticals BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 53225-3700_63b10664-98e5-89a2-e053-2991aa0a256b 53225-3700 HUMAN PRESCRIPTION DRUG ReadySharp Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050712 ANDA ANDA088299 Terrain Pharmaceuticals LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 53225-3800_63b10664-98e5-89a2-e053-2991aa0a256b 53225-3800 HUMAN PRESCRIPTION DRUG ReadySharp Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20050708 ANDA ANDA080408 Terrain Pharmaceuticals LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 53225-4000_60a4e591-ef5d-a33c-e053-2a91aa0adf26 53225-4000 HUMAN PRESCRIPTION DRUG ReadySharp Anesthetics plus Ketorolac Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Ketorolac Tromethamine KIT EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS 20151229 NDA NDA016964 Terrain Pharmaceuticals N 20181231 53225-4105_432c2026-99ed-49e0-e054-00144ff8d46c 53225-4105 HUMAN PRESCRIPTION DRUG ReadySharp Anesthetics plus Betamethasone Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Betamethasone Sodium Phosphate and Betamethasone Acetate KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR 20151229 NDA NDA016964 Terrain Pharmaceuticals E 20171231 53225-4210_60a4e591-ef99-a33c-e053-2a91aa0adf26 53225-4210 HUMAN PRESCRIPTION DRUG ReadySharp Anesthetics plus Dexamethasone Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Dexamethasone Sodium Phosphate KIT EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS 20151229 NDA NDA016964 Terrain Pharmaceuticals N 20181231 53225-4315_43775cf1-4478-449a-e054-00144ff88e88 53225-4315 HUMAN PRESCRIPTION DRUG ReadySharp Anesthetics plus MethylPrednisolone 80 Lidocaine Hydrochloride, Bupivacaine Hydrochloride, and Methylprednisolone Acetate KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20151229 NDA NDA016964 Terrain Pharmaceuticals E 20171231 53225-5000_63276e81-b7d7-0a14-e053-2991aa0a63c0 53225-5000 HUMAN PRESCRIPTION DRUG Pre and Post Sx Pouch Mupirocin 2%, Dimethicone 5%, Chlorhexidine Gluconate 4% KIT TOPICAL 20091030 ANDA ANDA065123 Terrain Pharmaceuticals N 20191231 53228-001_55d9ef67-401a-4127-ac3b-fc2a2188ae60 53228-001 HUMAN OTC DRUG finipil pro/elec BENZETHONIUM CHLORIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part333A Equibal, Inc. BENZETHONIUM CHLORIDE 195 mg/100mL N 20181231 53228-002_dd46c6be-b81f-4b15-bb3f-bc0a7272d335 53228-002 HUMAN OTC DRUG BlemFree SALICYLIC ACID LOTION TOPICAL 20140801 OTC MONOGRAPH FINAL part333D Equibal, Inc. SALICYLIC ACID .587 g/118mL N 20181231 53228-050_25d8d7a6-f396-42d1-99ec-483b73ddc7e6 53228-050 HUMAN OTC DRUG finipil Lait 50 BENZETHONIUM CHLORIDE CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part333A Equibal, Inc. BENZETHONIUM CHLORIDE 195 mg/100mL N 20181231 53228-230_d7488a52-d6af-495b-9ea9-fca77873f8d4 53228-230 HUMAN OTC DRUG QuickMend BENZETHONIUM CHLORIDE LIQUID TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part333A Equibal, Inc. BENZETHONIUM CHLORIDE .09 mg/9mL N 20181231 53238-001_704df6e8-8203-4b26-8d7e-45ea367dba33 53238-001 HUMAN OTC DRUG PERIOSCIENCES White Care AO Pro SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20120913 OTC MONOGRAPH FINAL part355 PERIOSCIENCES LLC SODIUM FLUORIDE .24 mg/100mL N 20181231 53238-002_7b95d761-0132-4ea7-87b9-65a76e23b59a 53238-002 HUMAN OTC DRUG PERIOSCIENCES SENSITIVE AO Pro POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20130527 OTC MONOGRAPH NOT FINAL part356 PERIOSCIENCES LLC POTASSIUM NITRATE; SODIUM MONOFLUOROPHOSPHATE 50; 1.3 mg/mL; mg/mL N 20181231 53238-003_624a13f4-3d95-4834-abb6-7545bc813992 53238-003 HUMAN OTC DRUG PERIOSCIENCES HYDRATING AO Pro SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20130527 OTC MONOGRAPH FINAL part355 PERIOSCIENCES LLC SODIUM MONOFLUOROPHOSPHATE 1.3 mg/mL N 20181231 53240-151_af2ec66e-18ce-47da-a66f-887ceff6356e 53240-151 HUMAN OTC DRUG Zephrex-D Pseudoephedrine Hydrochloride TABLET ORAL 20121115 OTC MONOGRAPH FINAL part341 Westport Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 E 20171231 53240-220_df9aa254-079d-482d-848b-d85d06cd99ef 53240-220 HUMAN OTC DRUG CVS Health Non-Drowsy Nasal Decongestant Pseudoephedrine Hydrochloride PILL ORAL 20151005 OTC MONOGRAPH FINAL part341 Westport Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 E 20171231 53240-240_cd2652b3-0228-4510-b7e1-f6b175914b78 53240-240 HUMAN OTC DRUG CVS Health Non-Drowsy Nasal Decongestant Pseudoephedrine Hydrochloride PILL ORAL 20151005 OTC MONOGRAPH FINAL part341 Westport Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 E 20171231 53240-280_1ee84888-9ec5-42e4-81d2-fe1c0cf4c4f9 53240-280 HUMAN OTC DRUG CVS Health Non-Drowsy Nasal Decongestant Pseudoephedrine Hydrochloride PILL ORAL 20151005 OTC MONOGRAPH FINAL part341 Westport Pharmaceuticals PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 E 20171231 53241-010_0627afa2-1500-4316-b7bf-ecb3259c74e7 53241-010 HUMAN OTC DRUG RACHEL K MINERAL CC BLEMISH BALM TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20120115 OTC MONOGRAPH FINAL part352 RACHEL K COSMETICS PTE. LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 2.4; 2; .8 g/40g; g/40g; g/40g E 20171231 53241-020_854a0f8d-21b6-48de-b07b-7a287424df57 53241-020 HUMAN OTC DRUG RACHEL K MINERAL CC PRESSED TITANIUM DIOXIDE POWDER TOPICAL 20120115 OTC MONOGRAPH FINAL part352 RACHEL K COSMETICS PTE. LTD. TITANIUM DIOXIDE .84 g/12g E 20171231 53247-101_9c7a4811-d025-486b-9a3f-693477c8c607 53247-101 HUMAN OTC DRUG Nature Mint Anti-cavity SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20150115 OTC MONOGRAPH FINAL part355 Bob Barker Company Inc. SODIUM MONOFLUOROPHOSPHATE .1 g/100g E 20171231 53247-102_d6fd65fd-1a53-4d2d-9a8e-2da01b34da7d 53247-102 HUMAN OTC DRUG Maximum Security Sodium Fluoride GEL, DENTIFRICE ORAL 20150115 OTC MONOGRAPH FINAL part355 Bob Barker Company Inc. SODIUM FLUORIDE .1 g/100g E 20171231 53247-103_30fabe05-c33c-4e66-9aa4-a75e7cd468c3 53247-103 HUMAN OTC DRUG CinnaFresh Anti-cavity Sodium Fluoride GEL, DENTIFRICE ORAL 20150115 OTC MONOGRAPH FINAL part355 Bob Barker Company Inc. SODIUM FLUORIDE .1 g/100g E 20171231 53247-104_a80c251a-8883-45f1-a9c4-b930e10b00a4 53247-104 HUMAN OTC DRUG Bob Barker Antibacterial wrapped body Triclocarban SOAP CUTANEOUS 20160801 OTC MONOGRAPH NOT FINAL part333E Bob Barker Company Inc. TRICLOCARBAN .16 g/100g E 20171231 53247-105_ee31ab07-9510-4332-8e05-a5f42bd93bb4 53247-105 HUMAN OTC DRUG Bob Barker Antibacterial wrapped body BENZETHONIUM CHLORIDE SOAP CUTANEOUS 20170101 OTC MONOGRAPH NOT FINAL part333E Bob Barker Company Inc. BENZETHONIUM CHLORIDE .1 g/100g N 20191231 53247-106_536a5394-78cb-40b6-b27f-7e288f009a91 53247-106 HUMAN OTC DRUG Bob Barker Antibacterial unwrapped body BENZETHONIUM CHLORIDE SOAP CUTANEOUS 20170101 OTC MONOGRAPH NOT FINAL part333E Bob Barker Company Inc. BENZETHONIUM CHLORIDE .1 g/100g N 20181231 53247-107_5a05ba5f-2a70-4bca-be1b-bac4706eb7e6 53247-107 HUMAN OTC DRUG Bob Barker Antibacterial wrapped body BENZETHONIUM CHLORIDE SOAP CUTANEOUS 20170601 OTC MONOGRAPH NOT FINAL part333E Bob Barker Company Inc. BENZETHONIUM CHLORIDE .1 g/100g N 20181231 53247-108_2a1d2aaf-62ae-49cf-a2f8-c659ae7a9d0b 53247-108 HUMAN OTC DRUG Nature Mint Anticavity Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20080101 OTC MONOGRAPH FINAL part355 Bob Barker Company Inc. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20191231 53247-109_b56ccf02-8f04-4348-96ac-4ac111ddf656 53247-109 HUMAN OTC DRUG Maximum Security Sodium Fluoride GEL, DENTIFRICE DENTAL 20080101 OTC MONOGRAPH FINAL part355 Bob Barker Company Inc. SODIUM FLUORIDE 2.2 mg/g N 20191231 53247-110_b343585e-fcda-42b0-8540-291c7462624d 53247-110 HUMAN OTC DRUG Cinnafresh Sodium Fluoride GEL, DENTIFRICE DENTAL 20080101 OTC MONOGRAPH FINAL part355 Bob Barker Company Inc. SODIUM FLUORIDE 2.2 mg/g N 20191231 53247-330_1ebb194f-95a4-44ba-a8a4-601195773ae0 53247-330 HUMAN OTC DRUG Liceall piperonyl butoxide, pyrethrum extract SHAMPOO TOPICAL 20100420 OTC MONOGRAPH FINAL part358G Bob Barker Company, Inc. PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 3; .3 g/100mL; g/100mL N 20181231 53247-467_e2095929-dc25-421a-8076-2816c9d5fca3 53247-467 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol GEL TOPICAL 20121008 OTC MONOGRAPH NOT FINAL part333A Bob Barker ALCOHOL 62 mL/100mL N 20181231 53247-600_5fa66d16-4ebd-4993-a1c8-8167b5495708 53247-600 HUMAN OTC DRUG bob barker antibacterial bar Triclosan SOAP TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part333E Bob Barker Company Inc. TRICLOSAN .16 g/100g E 20171231 53247-750_f7963a04-98a2-4030-ac9b-fac55af9242c 53247-750 HUMAN OTC DRUG Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SPRAY TOPICAL 20170622 OTC MONOGRAPH FINAL part350 Bob Barker Company ALUMINUM CHLOROHYDRATE 13 mg/100mL N 20181231 53247-752_35a7ac80-34c6-4dbb-8d55-498d5997efde 53247-752 HUMAN OTC DRUG Roll On Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20131104 OTC MONOGRAPH FINAL part350 Bob Barker Inc. ALUMINUM CHLOROHYDRATE 10 mg/100mL N 20181231 53262-001_b5eae714-d753-42ea-a3a1-c3a8ed6e6db2 53262-001 HUMAN OTC DRUG In-7-One SODIUM MONOFLUOROPHOSPHATE GEL, DENTIFRICE DENTAL 20130606 OTC MONOGRAPH FINAL part355 Power Unit Toothbrush Inc SODIUM MONOFLUOROPHOSPHATE .14 g/100g E 20171231 53270-0051_148e1fa7-efc7-47be-a20a-1e9a623852e2 53270-0051 PLASMA DERIVATIVE HepaGam B Hepatitis B Immune Globulin (Human) INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 BLA BLA125035 Cangene bioPharma Inc. HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU]/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] N 20181231 53270-0052_148e1fa7-efc7-47be-a20a-1e9a623852e2 53270-0052 PLASMA DERIVATIVE HepaGam B Hepatitis B Immune Globulin (Human) INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 BLA BLA125035 Cangene bioPharma Inc. HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU]/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] N 20181231 53270-0053_3564c384-dfe3-26a3-e054-00144ff88e88 53270-0053 HUMAN PRESCRIPTION DRUG HepaGam B Hepatitis B Immune Globulin (Human) INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 BLA BLA125035 Cangene BioPharma, LLC HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 50 mg/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] N 20181231 53270-0054_3564c384-dfe3-26a3-e054-00144ff88e88 53270-0054 HUMAN PRESCRIPTION DRUG HepaGam B Hepatitis B Immune Globulin (Human) INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100801 BLA BLA125035 Cangene BioPharma, LLC HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 50 mg/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] N 20181231 53270-0126_1743d54c-b53e-4a93-9bcb-41caf047fc10 53270-0126 PLASMA DERIVATIVE VARIZIG Varicella Zoster Immune Globulin (Human) LIQUID INTRAMUSCULAR 20150522 BLA BLA125430 Cangene BioPharma HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN 1.25 [iU]/mL N 20181231 53270-0270_29c7770e-4219-49a9-871b-70317ff88ecb 53270-0270 HUMAN PRESCRIPTION DRUG Ixinity coagulation factor IX (recombinant) KIT 20150501 BLA BLA125426 Cangene BioPharma N 20181231 53270-0271_29c7770e-4219-49a9-871b-70317ff88ecb 53270-0271 HUMAN PRESCRIPTION DRUG Ixinity coagulation factor IX (recombinant) KIT 20150501 BLA BLA125426 Cangene BioPharma N 20181231 53270-0272_29c7770e-4219-49a9-871b-70317ff88ecb 53270-0272 HUMAN PRESCRIPTION DRUG Ixinity coagulation factor IX (recombinant) KIT 20150501 BLA BLA125426 Cangene BioPharma N 20181231 53270-3000_365b94c7-f55e-4824-e054-00144ff8d46c 53270-3000 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20050331 BLA BLA103649 Cangene BioPharma, LLC HUMAN IMMUNOGLOBULIN G 15000 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 53270-3100_365b94c7-f55e-4824-e054-00144ff8d46c 53270-3100 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20040331 BLA BLA103649 Cangene BioPharma, LLC HUMAN IMMUNOGLOBULIN G 5000 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 53270-3120_365b94c7-f55e-4824-e054-00144ff8d46c 53270-3120 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20050331 BLA BLA103649 Cangene BioPharma, LLC HUMAN IMMUNOGLOBULIN G 600 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 53270-3300_365b94c7-f55e-4824-e054-00144ff8d46c 53270-3300 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20050331 BLA BLA103649 Cangene BioPharma, LLC HUMAN IMMUNOGLOBULIN G 1500 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 53270-3500_365b94c7-f55e-4824-e054-00144ff8d46c 53270-3500 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20050331 BLA BLA103649 Cangene BioPharma, LLC HUMAN IMMUNOGLOBULIN G 2500 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 53304-0301_46b38a46-4d28-4a88-aaec-ed23e9ff3f70 53304-0301 HUMAN OTC DRUG EB301AP PAIN RELIEF MENTHOL SPRAY TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 EMINENCE BIOTECH CORPORATION LIMITED MENTHOL 1000 mg/100mL N 20181231 53304-0302_b3f3d999-4018-49cc-a71f-5535af660860 53304-0302 HUMAN OTC DRUG EB302 ARTHRITIS RELIEF MENTHOL SPRAY TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part348 EMINENCE BIOTECH CORPORATION LIMITED MENTHOL 865.4 mg/50mL N 20181231 53304-0306_3b11ba92-3a4b-49cf-9aea-88fd0fc04ed4 53304-0306 HUMAN OTC DRUG EB306 NASAL DECONGESTANT PHENYLEPHRINE HYDROCHLORIDE SPRAY NASAL 20121101 OTC MONOGRAPH FINAL part341 EMINENCE BIOTECH CORPORATION LIMITED PHENYLEPHRINE HYDROCHLORIDE 21.73 mg/15mL N 20181231 53304-1301_a1a9bac8-a4cc-4d5a-b042-c85bf1a41e2e 53304-1301 HUMAN OTC DRUG EB301CT BRUISE PAIN RELIEF MENTHOL SPRAY TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 EMINENCE BIOTECH CORPORATION LIMITED MENTHOL 1700 mg/100mL N 20181231 53305-065_43b31c52-61f4-07b5-e054-00144ff88e88 53305-065 HUMAN OTC DRUG Dreumex Omnicare Hand Sanitizer Alcohol SPRAY TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part333E Dreumex USA, Inc. ALCOHOL 800 mg/1.2mL E 20171231 53329-001_d19b5b65-9403-4f76-8cc3-82cb2528df0e 53329-001 HUMAN OTC DRUG Hand Sanitizer Alcohol LIQUID TOPICAL 20170816 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ALCOHOL 62 mg/mL N 20181231 53329-002_5df4a292-7aea-5416-e053-2991aa0a06ce 53329-002 HUMAN OTC DRUG Epi-Clenz Hand Sanitizer ethyl alcohol GEL TOPICAL 20171114 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 70 mL/100mL N 20181231 53329-004_429eb530-1fb8-6072-e054-00144ff88e88 53329-004 HUMAN OTC DRUG Soothe and Cool Protect Zinc Oxide and White Petrolatum PASTE TOPICAL 20070101 20181231 OTC MONOGRAPH FINAL part346 Medline Industries, Inc. ZINC OXIDE; PETROLATUM 100; 500 mg/g; mg/g N 20181231 53329-004_61304306-da3c-5c75-e053-2a91aa0a7c6b 53329-004 HUMAN OTC DRUG Soothe and Cool Protect Zinc Oxide and White Petrolatum PASTE TOPICAL 20070101 OTC MONOGRAPH FINAL part346 Medline Industries, Inc. ZINC OXIDE; PETROLATUM 100; 500 mg/g; mg/g N 20181231 53329-005_61695035-4428-6ecc-e053-2a91aa0a5046 53329-005 HUMAN OTC DRUG Curad Saline Laxative sodium phosphate ENEMA RECTAL 20120716 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL N 20181231 53329-009_428b1cb9-7db9-3141-e054-00144ff8d46c 53329-009 HUMAN OTC DRUG Spectrum Ethyl alcohol GEL TOPICAL 20160815 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ALCOHOL 70 g/100mL N 20181231 53329-010_5dafbb8a-ee6d-4bc8-a7be-71be0d8d8619 53329-010 HUMAN OTC DRUG Antiperspirant aluminum chlorohydrate SPRAY TOPICAL 20100601 OTC MONOGRAPH FINAL part350 Medline Industries, Inc. ALUMINUM CHLOROHYDRATE 13 mg/100mL N 20191231 53329-013_ac600347-b7e8-49ce-93c1-ab6cf3149ec5 53329-013 HUMAN OTC DRUG Pure and Gentle mineral oil ENEMA RECTAL 20140409 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. MINERAL OIL 118 mL/118mL E 20171231 53329-014_5d1be431-b6bf-1cf6-e053-2a91aa0a4f9b 53329-014 HUMAN OTC DRUG Pure and Gentle Laxative sodium phosphate ENEMA RECTAL 20140409 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL N 20181231 53329-018_1ccf5a0a-1539-4c12-bf87-763814a313c8 53329-018 HUMAN OTC DRUG Skintegrity Antibacterial Hand Amber Triclosan SOAP TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .5 mL/100mL E 20171231 53329-019_429f93a5-6925-1171-e054-00144ff88e88 53329-019 HUMAN OTC DRUG Skintegrity Antibacterial Hand Clear Triclosan SOAP TOPICAL 20120801 20181231 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .5 mg/100mL E 20171231 53329-042_61304306-da4b-5c75-e053-2a91aa0a7c6b 53329-042 HUMAN OTC DRUG Soothe and Cool Free Medseptic Skin Protectant Lanolin OINTMENT TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. LANOLIN 500 mg/g N 20181231 53329-043_f8366a24-06ac-4417-a1fc-ea7338a0781d 53329-043 HUMAN OTC DRUG Skintegrity Antibacterial Hand Blue Triclosan SOAP TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .5 mL/100mL E 20171231 53329-046_6290e040-d143-4915-a69e-1145e1350aff 53329-046 HUMAN OTC DRUG MedSpa Antibacterial Bar Triclosan SOAP TOPICAL 20150326 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .3 g/100g E 20171231 53329-047_30fe749e-022d-4e6a-b730-629fb015ca07 53329-047 HUMAN OTC DRUG MedSpa Antibacterial Bar Triclosan SOAP TOPICAL 20100802 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .3 g/100g E 20171231 53329-048_32a79fcc-a4ea-0b97-e054-00144ff8d46c 53329-048 HUMAN OTC DRUG Antibacterial Bar Triclosan SOAP TOPICAL 20100802 20181231 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .3 g/100g E 20171231 53329-050_77c48a65-060a-4d86-9a90-c308fd3c8bb8 53329-050 HUMAN OTC DRUG Skintegrity Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20080701 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 62 mL/100mL E 20171231 53329-055_32bb21ce-a8d8-33c0-e054-00144ff8d46c 53329-055 HUMAN OTC DRUG Medline ReadyBath Luxe Antibacterial Formula Benzalkonium Chloride CLOTH TOPICAL 20070101 20181231 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 mg/100mL E 20171231 53329-056_32bb21ce-a8d8-33c0-e054-00144ff8d46c 53329-056 HUMAN OTC DRUG Medline ReadyBath Luxe Antibacterial Formula Fragrance Free Benzalkonium Chloride CLOTH TOPICAL 20070101 20181231 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 mg/100mL E 20171231 53329-057_32bb21ce-a8d8-33c0-e054-00144ff8d46c 53329-057 HUMAN OTC DRUG Medline ReadyBath Select Antibacterial Formula Benzalkonium Chloride CLOTH TOPICAL 20070101 20181231 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 mg/100mL E 20171231 53329-058_32bb21ce-a8d8-33c0-e054-00144ff8d46c 53329-058 HUMAN OTC DRUG Medline ReadyBath Select Antibacterial Formula Fragrance Free Benzalkonium Chloride CLOTH TOPICAL 20070101 20181231 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 mg/100mL E 20171231 53329-059_2c11f189-e333-2d55-e054-00144ff8d46c 53329-059 HUMAN OTC DRUG Aloetouch Protect Fragrance Free Dimethicone CLOTH TOPICAL 20120801 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 3.2 g/100mL N 20181231 53329-067_2bd09078-61db-5b2b-e054-00144ff8d46c 53329-067 HUMAN OTC DRUG Soothe and Cool White Petrolatum OINTMENT TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM 935 mg/g N 20181231 53329-068_317a4a05-e093-09de-e054-00144ff88e88 53329-068 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20100101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM 1 g/g N 20181231 53329-069_f94c25c3-fd77-4c86-bdd2-2eb4115ba18c 53329-069 HUMAN OTC DRUG Roll On Anti Perspirant Alcohol Free Aluminum Chlorohydrate SOLUTION TOPICAL 20070101 OTC MONOGRAPH FINAL part350 Medline Industries, Inc. ALUMINUM CHLOROHYDRATE 10 mg/100mL N 20181231 53329-071_2bd52099-c290-3bcb-e054-00144ff88e88 53329-071 HUMAN OTC DRUG Soothe and Cool Moisture Barrier Petrolatum OINTMENT TOPICAL 20060301 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM 98.3 g/100g N 20181231 53329-072_a143042d-5de5-4440-8750-2b56f3b817c6 53329-072 HUMAN OTC DRUG Soothe and Cool Free Moisture Barrier Petrolatum OINTMENT TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM 92.8 g/100g N 20181231 53329-073_617e82d9-1c64-4ecc-e053-2a91aa0a7722 53329-073 HUMAN OTC DRUG MicroKlenz Antimicrobial Benzethonium Chloride LIQUID TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZETHONIUM CHLORIDE .1 mg/100mL N 20181231 53329-074_3c524259-b94b-53ca-e054-00144ff88e88 53329-074 HUMAN OTC DRUG Remedy Barrier Cream Cloths Fragrance Free Dimethicone CLOTH TOPICAL 20160831 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 3.6 g/100mL N 20181231 53329-075_32bdd802-16b4-184d-e054-00144ff88e88 53329-075 HUMAN OTC DRUG Readyflush Protect Wipes Fragrance Free Dimethicone CLOTH TOPICAL 20120801 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 3.2 g/100mL N 20181231 53329-076_59929aa1-aeee-4ac4-9174-f27ee631d870 53329-076 HUMAN OTC DRUG Carrington Moisture Barrier Petrolatum CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM .61 g/g N 20181231 53329-077_c726eb2d-4a2a-4bc6-b939-2d2f7d5e4965 53329-077 HUMAN OTC DRUG Carrington Moisture Barrier Zinc Oxide and Petrolatum CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. ZINC OXIDE; PETROLATUM .1; .78 g/g; g/g N 20181231 53329-078_3c524259-b94b-53ca-e054-00144ff88e88 53329-078 HUMAN OTC DRUG Remedy Barrier Cream Cloths Dimethicone CLOTH TOPICAL 20131219 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 3.6 g/100mL N 20181231 53329-079_2913f50f-cd26-2729-e054-00144ff88e88 53329-079 HUMAN OTC DRUG Carrington Antifungal Miconazole Nitrate CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part333C Medline Industries, Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 53329-080_60b649fe-4219-1c50-e053-2a91aa0a0c93 53329-080 HUMAN OTC DRUG Soothe And Cool Treat Miconazole Nitrate CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part333C Medline Industries, Inc. MICONAZOLE NITRATE 20 mg/100g N 20181231 53329-081_308859a9-a5f7-697b-e054-00144ff88e88 53329-081 HUMAN OTC DRUG SparkleFresh Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130711 OTC MONOGRAPH FINAL part355 Medline Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .1 g/100g N 20181231 53329-082_aa00b153-5524-4400-b24f-20dfdd74b272 53329-082 HUMAN OTC DRUG Sparkle Fresh Anticavity Sodium Fluoride PASTE, DENTIFRICE DENTAL 20080401 OTC MONOGRAPH FINAL part355 Medline Industries, Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 53329-083_0ff7b830-80c1-4824-812c-4a980a4e445c 53329-083 HUMAN OTC DRUG SparkleFresh Fluoride Toothpaste Sodium Monofluorophosphate PASTE, DENTIFRICE TOPICAL 20070101 OTC MONOGRAPH FINAL part355 Medline Industries, Inc. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 53329-086_480c5dd9-bd33-25bd-e054-00144ff88e88 53329-086 HUMAN OTC DRUG Medline Peroxi Fresh Mouthwash Hydrogen Peroxide MOUTHWASH DENTAL 20070101 OTC MONOGRAPH NOT FINAL part356 Medline Industries, Inc. HYDROGEN PEROXIDE 15 mg/mL N 20181231 53329-087_429f845a-0aa5-735f-e054-00144ff8d46c 53329-087 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin B sulfate OINTMENT TOPICAL 20100401 20181231 OTC MONOGRAPH FINAL part333B Medline Industries, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 53329-088_271b7e5b-e202-3ecc-e054-00144ff8d46c 53329-088 HUMAN OTC DRUG Anorectal zinc oxide, petrolatum CREAM TOPICAL 20100301 OTC MONOGRAPH FINAL part346 Medline Industries, Inc. PETROLATUM; ZINC OXIDE 800; 200 mg/g; mg/g N 20181231 53329-089_4c81cae1-adff-23d6-e054-00144ff88e88 53329-089 HUMAN OTC DRUG First Aid Antibiotic bacitracin zinc OINTMENT TOPICAL 20100301 OTC MONOGRAPH FINAL part333B Medline Industries, Inc. BACITRACIN ZINC 500 [USP'U]/g N 20181231 53329-090_13478652-6d0f-449f-8798-e733cecd6bda 53329-090 HUMAN OTC DRUG Vitamin A and D Skin Protectant OINTMENT TOPICAL 20100301 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. PETROLATUM 935 mg/g N 20181231 53329-091_fe98430c-e41a-488d-8d7f-0e379ee1d920 53329-091 HUMAN OTC DRUG Anti-itch hydrocortisone CREAM TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part348 Medline Industries, Inc. HYDROCORTISONE 10 mg/g N 20181231 53329-092_33b14134-937d-004c-e054-00144ff88e88 53329-092 HUMAN OTC DRUG Petroleum-Free Lip Balm Octinoxate and Oxybenzone LIPSTICK TOPICAL 20100401 OTC MONOGRAPH FINAL part352 Medline Industries, Inc. OCTINOXATE; OXYBENZONE 2; 4.5 g/100g; g/100g N 20181231 53329-094_617f72ab-4dd6-5abb-e053-2a91aa0a6739 53329-094 HUMAN OTC DRUG RadiaBlock Oxybenzone, Octinoxate LIPSTICK TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Medline Industries, Inc. OXYBENZONE; OCTINOXATE 30; 75 mg/g; mg/g N 20181231 53329-096_2b5e9166-c952-12c6-e054-00144ff88e88 53329-096 HUMAN OTC DRUG Remedy Zinc Skin Protectant White Petrolatum PASTE TOPICAL 20140403 OTC MONOGRAPH FINAL part347 Medline Industries Inc. ZINC OXIDE 20 g/100g N 20181231 53329-097_429ff009-9370-1e4c-e054-00144ff88e88 53329-097 HUMAN OTC DRUG Remedy Essentials White Petrolatum,Zinc Oxide PASTE TOPICAL 20161114 OTC MONOGRAPH FINAL part347 Medline Industries Inc. ZINC OXIDE; PETROLATUM 20; 75 g/100g; g/100g N 20181231 53329-101_b8ce719c-2014-4fff-85e2-7c712c1b0d50 53329-101 HUMAN OTC DRUG Natural Fiber Powder Sugar Free Orange Flavor Psyllium husk POWDER ORAL 20090101 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. PLANTAGO SEED 3400 mg/g N 20181231 53329-102_d8ced315-6830-4587-b8f3-3cc280b31d0c 53329-102 HUMAN OTC DRUG Natural Fiber Powder Orange Flavor Psyllium husk POWDER ORAL 20090101 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. PLANTAGO SEED 3400 mg/g N 20181231 53329-135_51db78c6-9d6c-54d4-e054-00144ff8d46c 53329-135 HUMAN OTC DRUG Remedy Phytoplex Calazime Protectant zinc oxide, menthol, white petrolatum, zinc oxide PASTE TOPICAL 20170613 OTC MONOGRAPH FINAL part346 Medline Industries, Inc. MENTHOL; PETROLATUM; ZINC OXIDE .45; 42; 20.6 g/100g; g/100g; g/100g N 20181231 53329-136_51da338f-d7b0-076a-e054-00144ff88e88 53329-136 HUMAN OTC DRUG Phytoplex Clear Aid White Petrolatum,Zinc Oxide PASTE TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Medline Industries Inc. PETROLATUM; ZINC OXIDE 71.5; 1 g/100g; g/100g N 20181231 53329-137_2b70b8c7-d6cf-4bd3-e054-00144ff88e88 53329-137 HUMAN OTC DRUG Z-Guard White Petrolatum,Zinc Oxide PASTE TOPICAL 20160106 OTC MONOGRAPH FINAL part347 Medline Industries Inc. PETROLATUM; ZINC OXIDE 57; 17 g/100g; g/100g N 20181231 53329-140_445b14a5-4404-3d1a-e054-00144ff88e88 53329-140 HUMAN OTC DRUG Remedy Skin Repair Dimethicone CREAM TOPICAL 20100301 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 1.5 g/100mL N 20181231 53329-142_2ae50b33-b4da-1020-e054-00144ff88e88 53329-142 HUMAN OTC DRUG Remedy Dimethicone Moisture Barrier Unscented Dimethicone CREAM TOPICAL 20100301 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 5 g/100mL N 20181231 53329-143_2ae5845b-7e6c-2210-e054-00144ff88e88 53329-143 HUMAN OTC DRUG Remedy Nutrashield Dimethicone CREAM TOPICAL 20100301 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 1 g/100mL N 20181231 53329-151_2b482136-72a6-1ad4-e054-00144ff8d46c 53329-151 HUMAN OTC DRUG Remedy Dimethicone Moisture Barrier Dimethicone CREAM TOPICAL 20070801 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 5 g/100mL N 20191231 53329-157_2b485d6d-c516-3e3d-e054-00144ff88e88 53329-157 HUMAN OTC DRUG Remedy Nutrashield Dimethicone LOTION TOPICAL 20050601 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 1 g/100mL N 20181231 53329-158_2b499ac7-0cd7-63b4-e054-00144ff8d46c 53329-158 HUMAN OTC DRUG Remedy Antimicrobial Cleanser benzalkonium chloride SOLUTION TOPICAL 20080801 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE 120 mg/100mL N 20181231 53329-160_2b49f585-c9c2-6687-e054-00144ff88e88 53329-160 HUMAN OTC DRUG Remedy Cleansing Body dimethicone LOTION TOPICAL 20080801 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 1.5 g/100mL N 20181231 53329-161_2b57e8ab-3afa-0e61-e054-00144ff88e88 53329-161 HUMAN OTC DRUG Remedy Skin Repair dimethicone CREAM TOPICAL 20080801 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 1.5 g/100mL N 20181231 53329-162_2b57dfe3-3ad0-2329-e054-00144ff88e88 53329-162 HUMAN OTC DRUG Remedy Antifungal With Olivamine Miconazole Nitrate CREAM TOPICAL 20070101 OTC MONOGRAPH FINAL part333C Medline Industries, Inc. MICONAZOLE NITRATE 2 g/100g N 20181231 53329-166_2b5a36c3-dd5f-7175-e054-00144ff88e88 53329-166 HUMAN OTC DRUG REMEDY Clear-Aid Skin Protectant White Petrolatum OINTMENT TOPICAL 20080301 OTC MONOGRAPH FINAL part347 Medline Industries, Inc PETROLATUM 500 mg/g N 20181231 53329-167_617ed970-8c30-6956-e053-2a91aa0a31eb 53329-167 HUMAN OTC DRUG Remedy with Phytoplex Antifungal Clear Miconazole Nitrate OINTMENT TOPICAL 20110801 OTC MONOGRAPH FINAL part333C Medline Industries Inc. MICONAZOLE NITRATE 2 g/100g N 20181231 53329-169_2b6d08de-e8a9-484f-e054-00144ff88e88 53329-169 HUMAN OTC DRUG Remedy Antifungal Miconazole Nitrate POWDER TOPICAL 20121119 OTC MONOGRAPH FINAL part333C Medline Industries, Inc. MICONAZOLE NITRATE 2 g/100g N 20181231 53329-171_3a5cda93-2607-65d4-e054-00144ff8d46c 53329-171 HUMAN OTC DRUG Remedy with Phytoplex Miconazole Nitrate OINTMENT TOPICAL 20160411 OTC MONOGRAPH FINAL part333C Medline Industries Inc. MICONAZOLE NITRATE 2 g/100g N 20181231 53329-177_61d2a6f1-fc16-3970-e053-2a91aa0a632e 53329-177 HUMAN OTC DRUG Cleanse Benzalkonium Chloride 0.13% SOLUTION TOPICAL 20160819 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20191231 53329-178_428644dd-b2d2-1675-e054-00144ff88e88 53329-178 HUMAN OTC DRUG Cleanse Benzalkonium Chloride 0.13% SOAP TOPICAL 20150819 20181231 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .13 g/100mL E 20171231 53329-179_4286c7f3-8c54-3ce4-e054-00144ff8d46c 53329-179 HUMAN OTC DRUG Cleanse Benzalkonium Chloride 0.10% SOAP TOPICAL 20150826 20181231 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 53329-180_32bc07dc-7aa3-63ed-e054-00144ff8d46c 53329-180 HUMAN OTC DRUG ReadyBath Luxe Benzalkonium Chloride CLOTH TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 g/100g N 20181231 53329-181_33378649-7afb-02fb-e054-00144ff88e88 53329-181 HUMAN OTC DRUG ReadyBath Luxe Benzalkonium Chloride CLOTH TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 g/100g N 20181231 53329-182_33378649-7aff-02fb-e054-00144ff88e88 53329-182 HUMAN OTC DRUG ReadyBath Select Benzalkonium Chloride CLOTH TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 g/100g N 20181231 53329-183_3337e8e6-937d-2099-e054-00144ff8d46c 53329-183 HUMAN OTC DRUG ReadyBath Select Benzalkonium Chloride CLOTH TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .12 g/100g N 20181231 53329-184_42867e8d-856b-2e98-e054-00144ff8d46c 53329-184 HUMAN OTC DRUG Cleanse Benzalkonium Chloride 0.10% SOLUTION TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 53329-201_61e43576-78b7-a4ab-e053-2a91aa0a9ba0 53329-201 HUMAN OTC DRUG Hand Sanitizer ethyl alcohol GEL TOPICAL 20150406 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 62 mL/100mL N 20191231 53329-202_61d1fcde-23ec-9573-e053-2a91aa0a5031 53329-202 HUMAN OTC DRUG Hand Sanitizer ethyl alcohol GEL TOPICAL 20150406 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 70 mL/100mL N 20191231 53329-203_fc24815d-bd68-44a0-8e90-f0ecf2da7d5f 53329-203 HUMAN OTC DRUG Epi-Clenz Pure Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20120402 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 70 mL/100mL N 20181231 53329-204_167ba39d-d9da-47c9-be45-64709757b125 53329-204 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20070920 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 70 mL/100mL N 20181231 53329-204_32aa75a5-49ba-35ab-e054-00144ff88e88 53329-204 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20070920 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 70 mL/100mL N 20181231 53329-207_5f9de24a-1904-44a6-9969-96fddb21f604 53329-207 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic Scented ethyl alcohol GEL TOPICAL 20070920 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 70 mL/100mL N 20181231 53329-208_d645ab34-1a96-48d1-b9d2-e2dd9e614f78 53329-208 HUMAN OTC DRUG Epi-Clenz Plus Instant Hand Antiseptic ethyl alcohol LOTION TOPICAL 20070920 OTC MONOGRAPH NOT FINAL part333 Medline Industries, Inc. ALCOHOL 62 mL/100mL N 20181231 53329-209_5c8dff94-d445-6ae4-e053-2a91aa0a7343 53329-209 HUMAN OTC DRUG Hand Sanitizer Alcohol LIQUID TOPICAL 20160527 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ALCOHOL .879 mg/mL N 20181231 53329-210_617e28e4-ce52-ba98-e053-2a91aa0ac8ed 53329-210 HUMAN OTC DRUG Epi-Clenz Plus Instant Hand Sanitizer ethyl alcohol CLOTH TOPICAL 20070301 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 65 mL/1 N 20181231 53329-211_429fdc33-6cb6-090a-e054-00144ff8d46c 53329-211 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20070920 OTC MONOGRAPH NOT FINAL part356 Medline Industries, Inc. ALCOHOL 70 mL/100mL N 20181231 53329-212_61e76e2a-fc48-7a64-e053-2991aa0a56a8 53329-212 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20130930 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 70 mL/100mL N 20191231 53329-213_4262f196-3d9e-1088-e054-00144ff88e88 53329-213 HUMAN OTC DRUG Spectrum ethyl alcohol SWAB TOPICAL 20160527 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ALCOHOL 1.82 mL/1 N 20181231 53329-301_3178bb85-d16e-2b11-e054-00144ff8d46c 53329-301 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20100805 ANDA ANDA077789 Medline Industries, Inc. CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 53329-302_2b5e3cf2-89ab-071d-e054-00144ff88e88 53329-302 HUMAN OTC DRUG Remedy Skin Protectant White Petrolatum PASTE TOPICAL 20131106 OTC MONOGRAPH FINAL part347 Medline Industries Inc. PETROLATUM 59 g/100g N 20181231 53329-303_2706366a-8cef-12f1-e054-00144ff8d46c 53329-303 HUMAN OTC DRUG Soothe and Cool Moisture Guard White Petrolatum PASTE TOPICAL 20131106 OTC MONOGRAPH FINAL part347 Medline Industries Inc. PETROLATUM 59 g/100g N 20181231 53329-410_a925113e-347e-4051-b092-f947b8252d74 53329-410 HUMAN OTC DRUG MediPlast salicylic acid PLASTER TOPICAL 20080801 OTC MONOGRAPH FINAL part358F Medline Industries, Inc SALICYLIC ACID 40 g/100g N 20181231 53329-497_6282cea1-ffe8-673f-e053-2a91aa0ae42b 53329-497 HUMAN OTC DRUG Medline Nasal Antiseptic Swabs Povidone Iodine swabstick SOLUTION TOPICAL 20180115 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc POVIDONE-IODINE 10 mg/mL N 20191231 53329-640_5f24c2c1-be3c-f0b8-e053-2991aa0a22e3 53329-640 HUMAN OTC DRUG Medline Acetaminophen Acetaminophen TABLET ORAL 20131226 OTC MONOGRAPH NOT FINAL part343 Medline Industries, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 53329-641_5fa1b3cf-7ff4-04c0-e053-2a91aa0a82da 53329-641 HUMAN OTC DRUG Medline Acetaminophen Acetaminophen TABLET ORAL 20131226 OTC MONOGRAPH NOT FINAL part343 Medline Industries, Inc. ACETAMINOPHEN 500 mg/1 N 20191231 53329-642_5f250a66-1d99-5aba-e053-2991aa0ad36f 53329-642 HUMAN OTC DRUG Medline Acetaminophen Acetaminophen TABLET ORAL 20131226 OTC MONOGRAPH NOT FINAL part343 Medline Industries, Inc. ACETAMINOPHEN 325 mg/1 N 20181231 53329-643_2de79711-ea0d-4c21-8cca-f90f3904f91b 53329-643 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Medline Industries, Inc. ACETAMINOPHEN 650 mg/1 N 20181231 53329-650_9788e4ad-bfc8-4256-88bd-8fa5a85af032 53329-650 HUMAN OTC DRUG Diphenhydramine HCl Allergy Antihistamine Diphenhydramine HCl TABLET ORAL 20130330 OTC MONOGRAPH FINAL part336 Medline Industries DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 53329-651_8012abf1-23da-4d42-8fb2-b6def38c1c74 53329-651 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Medline Industries, Inc. LORATADINE 10 mg/1 N 20181231 53329-652_617f8703-f68c-7afd-e053-2a91aa0ae9af 53329-652 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Medline Industries, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 53329-660_5f248cb7-b9f5-00b5-e053-2a91aa0a1a12 53329-660 HUMAN OTC DRUG Docusate Sodium Docusate Sodium TABLET, FILM COATED ORAL 20130116 OTC MONOGRAPH NOT FINAL part334 Medline Industries, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 53329-664_617f950b-8bb1-0e70-e053-2a91aa0ac066 53329-664 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Medline Industries, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 53329-671_ebfef89a-5117-4993-9e7e-0f6baff53453 53329-671 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20130430 ANDA ANDA079096 Medline Industries NAPROXEN SODIUM 220 mg/1 N 20181231 53329-673_5b200b19-2aa9-466c-e053-2991aa0a3c42 53329-673 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20130115 20181031 ANDA ANDA079174 Medline Industries IBUPROFEN 200 mg/1 N 20181231 53329-674_5a5ae85b-8265-5087-e053-2a91aa0acb60 53329-674 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20170929 ANDA ANDA079174 Medline industries, Inc. IBUPROFEN 200 mg/1 N 20181231 53329-675_1ffd186b-7380-4e17-919e-2352d112bd30 53329-675 HUMAN OTC DRUG Naproxen NAPROXEN SODIUM TABLET ORAL 20020726 NDA NDA020204 Medline Industries, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 53329-677_15821573-03c8-490f-9295-74430aa07dfe 53329-677 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20150421 ANDA ANDA076460 Medline industries, Inc. IBUPROFEN 200 mg/1 N 20181231 53329-680_6156618e-db3d-2f08-e053-2a91aa0a545e 53329-680 HUMAN OTC DRUG Natural Vegetable Laxative with Stool Softener docusate sodium and sennosides TABLET ORAL 20130430 OTC MONOGRAPH NOT FINAL part334 Medline Industries SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 53329-681_429aa257-c36e-43d8-e054-00144ff88e88 53329-681 HUMAN OTC DRUG Sennosides SENNOSIDES TABLET ORAL 20130330 20181231 OTC MONOGRAPH NOT FINAL part334 Medline Industries SENNOSIDES 8.6 mg/1 E 20171231 53329-682_614715df-5a42-7ecf-e053-2991aa0aa23b 53329-682 HUMAN OTC DRUG Sennosides SENNOSIDES TABLET ORAL 20160329 OTC MONOGRAPH NOT FINAL part334 Medline Industries SENNOSIDES 8.6 mg/1 N 20181231 53329-695_92f91121-229b-4942-b6d6-3d969c23a8fa 53329-695 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20120330 ANDA ANDA200536 Medline Industries, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 53329-776_32816022-a320-4435-e054-00144ff88e88 53329-776 HUMAN OTC DRUG Soothe and Cool Inzo Dimethicone CREAM TOPICAL 20160121 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 5 g/100mL N 20181231 53329-777_2bd41831-e010-6a20-e054-00144ff8d46c 53329-777 HUMAN OTC DRUG Soothe and Cool INZO Barrier Dimethicone CREAM TOPICAL 20090401 OTC MONOGRAPH FINAL part347 Medline Industries, Inc. DIMETHICONE 5 g/100mL N 20181231 53329-797_2c866e6c-68d3-2789-e054-00144ff8d46c 53329-797 HUMAN OTC DRUG Isopropyl alcohol Isopropyl alcohol SOLUTION TOPICAL 20150806 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 53329-798_d980969d-694b-4c9e-a931-73beaceb51da 53329-798 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20150630 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 53329-799_2c864240-fdc1-53db-e054-00144ff88e88 53329-799 HUMAN OTC DRUG Isopropyl alcohol Isopropyl alcohol SOLUTION TOPICAL 20150806 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 53329-800_32b9a6f4-9e7a-65a9-e054-00144ff8d46c 53329-800 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090216 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 53329-801_5fc8f7a4-68b2-5e96-e053-2991aa0ade72 53329-801 HUMAN OTC DRUG Medline Alcohol Prep Non-Sterile, Large Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 53329-807_617ee923-ce5c-5285-e053-2a91aa0adf88 53329-807 HUMAN OTC DRUG Medline Alcohol Swabstick Triples Isopropyl Alcohol SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 53329-809_5f9b892f-7ef4-498b-e053-2a91aa0a3026 53329-809 HUMAN OTC DRUG Medline Alcohol Prep Medium Isopropyl Alcohol SWAB TOPICAL 20121207 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 53329-824_429db076-5225-235c-e054-00144ff8d46c 53329-824 HUMAN OTC DRUG Curad Alcohol Non-Sterile, Medium Isopropyl Alcohol SWAB TOPICAL 20070101 20181231 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 53329-827_5f859a1e-0996-50ef-e053-2991aa0ae02a 53329-827 HUMAN OTC DRUG Curad Alcohol Prep Pads Medium Isopropyl Alcohol SWAB TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 53329-875_32ba9442-7d18-172d-e054-00144ff8d46c 53329-875 HUMAN OTC DRUG CURAD Isopropyl Alcohol isopropyl alcohol LIQUID TOPICAL 20120301 20181231 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. ISOPROPYL ALCOHOL 91 mL/100mL E 20171231 53329-906_428ac6d9-f532-1adc-e054-00144ff8d46c 53329-906 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL 20150712 20181231 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. POVIDONE-IODINE 1 g/100mL E 20171231 53329-920_2c8a1173-b857-19fb-e054-00144ff8d46c 53329-920 HUMAN OTC DRUG Scrub-In Surgical Scrub Brush/Sponge Povidone-Iodine SOLUTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE .9 g/100mL N 20181231 53329-921_2c8b1790-b6b4-147d-e054-00144ff88e88 53329-921 HUMAN OTC DRUG Scrub-In Surgical Scrub Brush/Sponge Povidone-Iodine SOLUTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE .15 g/100mL N 20181231 53329-923_2c8978ea-83d9-5a37-e054-00144ff88e88 53329-923 HUMAN OTC DRUG Scrub-In Surgical Scrub Brush/Sponge Chloroxylenol SOLUTION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. CHLOROXYLENOL 3.3 mg/100mL N 20181231 53329-924_2c8a3cb2-4923-1d65-e054-00144ff8d46c 53329-924 HUMAN OTC DRUG Scrub-In Surgical Scrub Brush/Sponge Chloroxylenol SOLUTION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. CHLOROXYLENOL 4 mg/100mL N 20181231 53329-938_4c84a6c3-5604-0aa7-e054-00144ff88e88 53329-938 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE .75 g/100mL N 20181231 53329-939_5c8e68b7-8665-9de3-e053-2a91aa0a5ae0 53329-939 HUMAN OTC DRUG Povidone-Iodine Topical Antiseptic Povidone-Iodine SOLUTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 53329-940_28c05c5c-09d4-2c62-e054-00144ff8d46c 53329-940 HUMAN OTC DRUG Povidone-Iodine Prep Pads Medium Bulk Povidone-Iodine CLOTH TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 53329-941_28c05c5c-09d4-2c62-e054-00144ff8d46c 53329-941 HUMAN OTC DRUG Povidone-Iodine Prep Pads Medium Povidone-Iodine CLOTH TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 53329-942_149b1b36-224c-46dc-bf21-631f9b52b892 53329-942 HUMAN OTC DRUG Swabsticks Triple Pack Povidone-Iodine SWAB TOPICAL 20141126 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE 10 mg/100mg N 20181231 53329-943_42775923-a344-6149-e054-00144ff8d46c 53329-943 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL 20161104 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 53329-944_427798b7-67c7-4777-e054-00144ff88e88 53329-944 HUMAN OTC DRUG Povidone-Iodine Povidone-Iodine SOLUTION TOPICAL 20161104 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE 7.5 mg/mL N 20181231 53329-945_28c26a44-069a-4fa5-e054-00144ff88e88 53329-945 HUMAN OTC DRUG Povidone-Iodine Swabsticks Singles Povidone-Iodine SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 53329-946_28c26a44-069a-4fa5-e054-00144ff88e88 53329-946 HUMAN OTC DRUG Povidone-Iodine Swabsticks Triples Povidone-Iodine SWAB TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. POVIDONE-IODINE 10 mg/mL N 20181231 53329-970_4c9a1d21-8eea-5901-e054-00144ff8d46c 53329-970 HUMAN OTC DRUG Epi-Clenz Instant Hand Antiseptic ethyl alcohol AEROSOL, FOAM TOPICAL 20051230 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 62 mL/100mL N 20181231 53329-974_32837937-0d9c-09a9-e054-00144ff88e88 53329-974 HUMAN OTC DRUG Skintegrity Ethyl Alcohol SOLUTION TOPICAL 20160304 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 62 mL/100mL N 20181231 53329-975_32a77f4c-85a6-7497-e054-00144ff8d46c 53329-975 HUMAN OTC DRUG Skintegrity Foaming Hand Sanitizer Fragrance Free Ethyl Alcohol SOLUTION TOPICAL 20110408 20191231 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. ALCOHOL 62 mL/100mL E 20171231 53329-976_3637818b-8eca-4a32-ac15-f116c1aaae52 53329-976 HUMAN OTC DRUG Skintegrity Foaming Hand Sanitizer Alcohol Free Benzethonium Chloride SOLUTION TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. BENZETHONIUM CHLORIDE .2 mL/100mL E 20171231 53329-977_864262de-e2a2-435f-82fa-e81c9854ee70 53329-977 HUMAN OTC DRUG Skintegrity Antibacterial Hand Foaming with Skin Conditioners Triclosan SOAP TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .5 mL/100mL E 20171231 53329-978_8c01bcd8-6beb-4940-b5b3-02c3dec43cc1 53329-978 HUMAN OTC DRUG Skintegrity Antibacterial Hand Foaming Triclosan SOAP TOPICAL 20110408 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. TRICLOSAN .5 mL/100mL E 20171231 53329-979_774f14c6-aee7-4031-9223-0397ea31a47c 53329-979 HUMAN OTC DRUG Skintegrity Foaming Chloroxylenol SOAP TOPICAL 20150212 OTC MONOGRAPH NOT FINAL part333E Medline Industries, Inc. CHLOROXYLENOL .33 mg/1000mL E 20171231 53329-980_26a67a91-ee2e-6a6c-e054-00144ff88e88 53329-980 HUMAN OTC DRUG Hydrogen peroxide Hydrogen peroxide SOLUTION ORAL; TOPICAL 20150811 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. HYDROGEN PEROXIDE 3 mL/100mL N 20181231 53329-981_349d0947-0f5f-4ab5-e054-00144ff8d46c 53329-981 HUMAN OTC DRUG Hydrogen Peroxide First Aid Antiseptic Hydrogen Peroxide LIQUID TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. HYDROGEN PEROXIDE 3 mL/100mL N 20181231 53329-983_60a52099-844b-2703-e053-2a91aa0a3e62 53329-983 HUMAN OTC DRUG CURAD Hydrogen Peroxide hydrogen peroxide LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333A Medline Industries, Inc. HYDROGEN PEROXIDE 3 mL/100mL N 20181231 53341-056_01625d08-5cfd-45de-ac14-d3e6e637ed5e 53341-056 HUMAN OTC DRUG Instant Hand Sanitizer (Gel-Type) Instant Hand Sanitizer (Gel-Type) SOLUTION TOPICAL 20131105 OTC MONOGRAPH NOT FINAL part333A Tranzonic Companies ALCOHOL 62 mL/100mL E 20171231 53341-080_e032f2f0-34ae-43b9-85e6-37327be9cfd2 53341-080 HUMAN OTC DRUG Southern Soft Luxury Foam Antibacterial Hand Wash Chloroxylenol LIQUID TOPICAL 20070115 OTC MONOGRAPH NOT FINAL part333E CCP Industries CHLOROXYLENOL .003 mg/mL N 20181231 53341-515_fb93afea-40f3-4ac8-9ce9-e595431c20ed 53341-515 HUMAN OTC DRUG Global Clean Instant Hand Sanitizer alcohol GEL TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333E Tranzonic Companies ALCOHOL 600 mL/1000mL E 20171231 53345-002_035f4757-0d2d-4cab-a7bc-ec9a12fd6a29 53345-002 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part338 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 53345-003_720c5558-89bb-45d7-9e31-ce24a988e782 53345-003 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone 180 mg CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part332 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIMETHICONE 410 180 mg/1 N 20181231 53345-004_0b0e4538-4263-4241-b420-c5b60b2c54c0 53345-004 HUMAN OTC DRUG DayTime Cold and Flu acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20130615 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 53345-005_8e586ebe-c908-4908-a46a-906add065e9e 53345-005 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part338 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 53345-006_bb21cc5e-e5c6-44ea-b95e-0be0f0d48e8f 53345-006 HUMAN OTC DRUG Nighttime Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 53345-007_e2b8ccab-60ce-4044-8c14-0f46fe432527 53345-007 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130915 OTC MONOGRAPH FINAL part336 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 53345-008_5d78f27a-f1d9-4e7b-9007-1e01268ab181 53345-008 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH NOT FINAL part334 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DOCUSATE SODIUM 100 mg/1 N 20181231 53345-009_3a7df54c-b70a-4bce-8f0f-1a3974380537 53345-009 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH FINAL part332 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIMETHICONE 125 mg/1 N 20181231 53345-010_9b736fa8-0f88-487b-9b2b-c57ff689f1c7 53345-010 HUMAN OTC DRUG ACETAMINOPHEN (RED) ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20160404 OTC MONOGRAPH NOT FINAL part343 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd ACETAMINOPHEN 325 mg/1 N 20181231 53345-010_a0f00ba0-1233-42d2-bf86-4f656c54c21a 53345-010 HUMAN OTC DRUG ACETAMINOPHEN (RED) ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20130415 OTC MONOGRAPH NOT FINAL part343 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN 325 mg/1 N 20181231 53345-011_f90fb4b0-b2aa-4ba1-ae70-53a0a605b760 53345-011 HUMAN OTC DRUG Dextromethorphan HBr 15 mg Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20140130 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 53345-012_16f8c0c3-70c1-4836-b6fd-9e2986531c3c 53345-012 HUMAN OTC DRUG DayTime Sinus Relief acetaminophen, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20130615 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 53345-013_3f2c8791-6ee2-47a4-a4c0-955f8c985b68 53345-013 HUMAN OTC DRUG NightTime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20130615 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 53345-014_5d5b5531-1b06-407b-8a23-95f2ce5c4f5f 53345-014 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170214 ANDA ANDA206568 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd IBUPROFEN 200 mg/1 N 20181231 53345-014_a82d2cdc-474b-42ec-b663-0115a7c7b854 53345-014 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170713 ANDA ANDA206568 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd IBUPROFEN 200 mg/1 N 20181231 53345-014_c78b4351-ca3f-4fa2-961d-7074cad25a6f 53345-014 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20161006 ANDA ANDA206568 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd IBUPROFEN 200 mg/1 N 20181231 53345-015_61eeb288-b60a-4e20-8bd7-487b26df00f2 53345-015 HUMAN OTC DRUG DOCUSATE SODIUM 50 MG DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131112 OTC MONOGRAPH NOT FINAL part334 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DOCUSATE SODIUM 50 mg/1 N 20181231 53345-018_88f1771c-20e4-453b-b79d-cf4cf28d20d1 53345-018 HUMAN OTC DRUG DOCUSATE SODIUM 100mg Two-Tone DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131223 OTC MONOGRAPH NOT FINAL part334 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DOCUSATE SODIUM 100 mg/1 N 20181231 53345-019_67ef9fe9-4816-445a-bf48-5a9c5f2d764a 53345-019 HUMAN OTC DRUG Pain Relief Extra Strength ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20140106 OTC MONOGRAPH NOT FINAL part343 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN 500 mg/1 N 20181231 53345-020_42e74b5b-7b7b-4129-9158-17d06f5b075d 53345-020 HUMAN OTC DRUG Night Cold Flu Cough and Allergy acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20130529 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 53345-021_6011e637-57cd-1e67-e053-2991aa0a3374 53345-021 HUMAN OTC DRUG Daytime Severe Cold and Flu acetaminophen, dextromethorphan hydrobromide, Guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20140711 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20191231 53345-022_fb017820-528e-428e-94ed-e686fd7b8809 53345-022 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140813 OTC MONOGRAPH FINAL part338 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 53345-023_46116955-995c-421a-8c75-a05a5333346a 53345-023 HUMAN OTC DRUG DOCUSATE SODIUM 100mg Two-Tone DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20150410 OTC MONOGRAPH NOT FINAL part334 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. DOCUSATE SODIUM 100 mg/1 N 20181231 53345-023_c738990b-fc78-4f71-b965-78f9cb8277d9 53345-023 HUMAN OTC DRUG DOCUSATE SODIUM 100mg Two-Tone DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140811 OTC MONOGRAPH NOT FINAL part334 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DOCUSATE SODIUM 100 mg/1 N 20181231 53345-025_47a55c86-d377-4dc8-9729-47937a255984 53345-025 HUMAN OTC DRUG DayTime Cold and Flu acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20140811 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 53345-026_1cb03e64-8432-42f7-ac4d-9c134614b369 53345-026 HUMAN OTC DRUG Nighttime Cold and Flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20140811 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 53345-027_c1fcb444-588c-4e60-832a-008d1b7eda46 53345-027 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20141014 OTC MONOGRAPH FINAL part338 Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 53345-028_43b370cb-1096-4e64-ac31-7e41046a48b3 53345-028 HUMAN OTC DRUG Dextromethorphan HBr 15 mg Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20141210 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 53345-029_c454481c-002e-4c2b-a675-4ef4f4c52b73 53345-029 HUMAN OTC DRUG DOCUSATE SODIUM 100mg DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20150128 OTC MONOGRAPH NOT FINAL part334 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. DOCUSATE SODIUM 100 mg/1 N 20181231 53345-030_357cf5ce-5a3e-42fd-aa99-0f51be6efd86 53345-030 HUMAN OTC DRUG DayTime Sinus acetaminophen, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20150226 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 53345-031_fe0ef383-04b0-4178-91bb-3dcee44d8d37 53345-031 HUMAN OTC DRUG NightTime Sinus Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20150226 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 53345-032_48569d4d-19fe-4dc6-b2f6-b77429cf848e 53345-032 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20160630 OTC MONOGRAPH FINAL part332 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd DIMETHICONE 250 mg/1 N 20181231 53345-032_bd599eec-8279-45ae-ad56-7c965237c86a 53345-032 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20150128 OTC MONOGRAPH FINAL part332 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. DIMETHICONE 250 mg/1 N 20181231 53345-033_1412f118-cecc-4b79-9c02-81756b361f4e 53345-033 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20150128 OTC MONOGRAPH FINAL part332 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. DIMETHICONE 125 mg/1 N 20181231 53345-034_817df886-3f94-4e7f-9d41-5045e705ee0b 53345-034 HUMAN OTC DRUG Maximum Strength-Cough and Chest Congestion DM Maximum Strength-Cough and Chest Congestion DM CAPSULE, LIQUID FILLED ORAL 20150630 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 N 20181231 53345-035_70b1c0b0-3a58-401b-a6f7-841db7cc0744 53345-035 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20160210 OTC MONOGRAPH NOT FINAL part334 Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd DOCUSATE SODIUM 250 mg/1 N 20181231 53345-036_e0366d3d-cb59-448b-97ba-f1cc207138a0 53345-036 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20160725 OTC MONOGRAPH FINAL part332 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd DIMETHICONE 180 mg/1 N 20181231 53345-039_1c7c75b3-481a-45b5-b080-aaee27d30cec 53345-039 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170323 ANDA ANDA206568 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd IBUPROFEN 200 mg/1 N 20181231 53345-039_22cac392-8791-4c6d-a7b3-cce9a63fb8a4 53345-039 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170713 ANDA ANDA206568 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd IBUPROFEN 200 mg/1 N 20181231 53345-045_7bc9510d-f1f4-4274-ae2e-15df159a4c66 53345-045 HUMAN OTC DRUG Cough and Cold plus Acetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate, Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20170324 OTC MONOGRAPH FINAL part341 Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 325; 5; 2; 10 mg/1; mg/1; mg/1; mg/1 N 20181231 53346-0515_c1ed5356-714f-418f-89f9-36bb4093f8df 53346-0515 HUMAN OTC DRUG DR. RECKEWEG v-C15 Homeopathic preparation Cocculus indicus 5X, Helonias dioica 5X, Ignatia amara 5X, Phosphoricum acidum 3X, Sepia 6X, Zincum metallicum 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ANAMIRTA COCCULUS SEED; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; ZINC 5; 5; 5; 3; 6; 6 [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL N 20181231 53346-1301_fa3ddce8-4c81-44d6-b6fb-24a205b2f5cc 53346-1301 HUMAN OTC DRUG DR. RECKEWEG R1 Anginacid Combination Product Apis mellifica 4X, Baryta muriatica 6X, Belladonna 4X, Calcarea iodata 4X, Hepar sulphuris calcareum 12X, Kali bichromicum 4X, Lachesis mutus 12X, Teucrium marum 6X, Mercurius corrosivus 6X, Phytolacca decandra 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO APIS MELLIFERA; BARIUM CHLORIDE DIHYDRATE; ATROPA BELLADONNA; CALCIUM IODIDE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; TEUCRIUM MARUM; MERCURIC CHLORIDE; PHYTOLACCA AMERICANA ROOT 4; 6; 4; 4; 12; 4; 12; 6; 6; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1304_b8455c48-a727-4a2e-8e62-70affad974e3 53346-1304 HUMAN OTC DRUG DR. RECKEWEG R4 Enterocolin Combination Product Baptisia tinctoria 4X, Chamomilla 4X, Chininum arsenicosum 6X, Colocynthis 6X, Ferrum phosphoricum 8X, Mercurius corrosivus 6X, Oleander 6X, Phosphoricum acidum 3X, Rhus toxicodendron 4X, Veratrum album 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO BAPTISIA TINCTORIA ROOT; MATRICARIA RECUTITA; QUININE ARSENITE; CITRULLUS COLOCYNTHIS FRUIT PULP; FERRIC PHOSPHATE; MERCURIC CHLORIDE; NERIUM OLEANDER LEAF; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT 4; 4; 6; 6; 8; 6; 6; 3; 4; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1305_aa1a1f3b-38d6-482e-81d5-5a81cc5e2211 53346-1305 HUMAN OTC DRUG Dr. RECKEWEG R5 Gastreu Combination Product Anacardium orientale 6X, Argentum nitricum 6X, Arsenicum album 6X, Belladonna 4X, Carbo vegetabilis 8X, Chamomilla 2X, Chelidonium majus, radix 3X, Lycopodium clavatum 5X, Nux vomica 4X, Scrophularia nodosa 1X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO SEMECARPUS ANACARDIUM FRUIT; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CHELIDONIUM MAJUS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SCROPHULARIA NODOSA 6; 6; 6; 4; 8; 2; 3; 5; 4; 1 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1307_e7966e97-7072-42cd-b9ed-491f9e3a5163 53346-1307 HUMAN OTC DRUG DR. RECKEWEG R7 Hepagalen Combination Product Carduus marianus 2X, Chelidonium majus, radix 2X, Cinchona 3X, Cholesterinum 6X, Colocynthis 6X, Lycopodium clavatum 4X, Nux vomica 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS ROOT; CINCHONA BARK; CHOLESTEROL; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED 2; 2; 3; 6; 6; 4; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1309_e7745d5c-f957-45e3-a9a9-35c4576e027b 53346-1309 HUMAN OTC DRUG DR. RECKEWEG R9 Jutussin Combination Product Belladonna 4X, Bryonia 4X, Coccus cacti 6X, Corallium rubrum 12X, Cuprum aceticum 12X, Drosera 4X, Ipecacuanha 6X, Spongia tosta 6X, Sticta pulmonaria 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ATROPA BELLADONNA; BRYONIA DIOICA ROOT; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; CUPRIC ACETATE; DROSERA ROTUNDIFOLIA; IPECAC; SPONGIA OFFICINALIS SKELETON, ROASTED; LOBARIA PULMONARIA 4; 4; 6; 12; 12; 4; 6; 6; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1310_f94cf9a1-c478-496e-adee-54458759ebd2 53346-1310 HUMAN OTC DRUG Dr. Reckeweg R10 Klimakteran Combination Product Cimicifuga racemosa 6X, Lachesis mutus 12X, Sanguinaria canadensis 6X, Sepia 6X, Sulfuricum acidum 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO BLACK COHOSH; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFURIC ACID 6; 12; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1311_b5f52b48-748e-492b-8839-aecea0d6c5bc 53346-1311 HUMAN OTC DRUG DR. RECKEWEG R11 Lumbagin Combination Product Berberis vulgaris 4X, Calcarea phosphorica 12X, Causticum 6X, Dulcamara 4X, Nux vomica 4X, Rhododendron chrysanthum 4X, Rhus toxicodendron 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO BERBERIS VULGARIS ROOT BARK; CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE; CAUSTICUM; SOLANUM DULCAMARA TOP; STRYCHNOS NUX-VOMICA SEED; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 4; 12; 6; 4; 4; 4; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1313_e002f75e-45f8-4b61-8772-0c3d10627e80 53346-1313 HUMAN OTC DRUG DR. RECKEWEG R13 Prohaemorrhin Combination Product Aesculus hippocastanum 2X, Collinsonia canadensis 4X, Graphites 8X, Hamamelis virginiana 3X, Kali carbonicum 6X, Lycopodium clavatum 5X, Nitricum acidum 6X, Nux vomica 4X, Paeonia officinalis 3X, Sulphur 5X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO HORSE CHESTNUT; COLLINSONIA CANADENSIS ROOT; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; SULFUR 2; 4; 8; 3; 6; 5; 6; 4; 3; 5 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1314_b3f078a8-34d3-4202-8f73-7450a1b31fd6 53346-1314 HUMAN OTC DRUG DR. RECKEWEG R14 Quieta Combination Product Ammonium bromatum 3X, Avena sativa 1X, Chamomilla 4X, Coffea cruda 4X, Eschscholtzia californica 2X, Humulus lupulus 2X, Ignatia amara 6X, Passiflora incarnata 2X, Valeriana officinalis 1X, Zincum valerianicum 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO AMMONIUM BROMIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; ESCHSCHOLZIA CALIFORNICA FLOWERING TOP; HOPS; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; ZINC VALERATE DIHYDRATE 3; 1; 4; 4; 2; 2; 6; 2; 1; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1316_ae122ddf-a5ea-4887-b6e6-f4393160b430 53346-1316 HUMAN OTC DRUG DR. RECKEWEG R16 Cimisan Combination Product Cimicifuga racemosa 4X, Gelsemium sempervirens 3X, Iris versicolor 2X, Sanguinaria canadensis 3X, Spigelia anthelmia 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA 4; 3; 2; 3; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1317_ca3e89de-3292-4451-98b8-9dc86233ecf5 53346-1317 HUMAN OTC DRUG DR. RECKEWEG R17 Cobralactin Combination Product Lacticum acidum 4X, Naja tripudians 8X, Scrophularia nodosa 2X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO LACTIC ACID, DL-; NAJA NAJA VENOM; SCROPHULARIA NODOSA 4; 8; 2 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1318_a3569fae-a569-4a80-859c-365731bec440 53346-1318 HUMAN OTC DRUG DR. RECKEWEG R18 Cystophylin Combination Product Berberis vulgaris 4X, Cantharis 4X, Dulcamara 4X, Equisetum hyemale 6X, Eupatorium purpureum 3X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; SOLANUM DULCAMARA TOP; EQUISETUM HYEMALE; EUTROCHIUM PURPUREUM ROOT 4; 4; 4; 6; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1323_c052dd9d-f6d4-4f5c-beba-dc302388bc98 53346-1323 HUMAN OTC DRUG DR. RECKEWEG R23 Nosoderm Combination Product Apis mellifica 30X, Arsenicum album 30X, Rhus toxicodendron 30X, Sulphur 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO APIS MELLIFERA; ARSENIC TRIOXIDE; TOXICODENDRON PUBESCENS LEAF; SULFUR 30; 30; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1325_e7b47449-855c-40f0-8f6d-3fb7d7e04d14 53346-1325 HUMAN OTC DRUG DR. RECKEWEG R25 Prostatan Combination Product Chimaphila umbellata 6X, Conium maculatum 6X, Ferrum picricum 6X, Pareira brava 6X, Populus tremuloides 6X, Pulsatilla 6X, Sabal serrulata 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO CHIMAPHILA UMBELLATA; CONIUM MACULATUM FLOWERING TOP; FERRIC PICRATE; CHONDRODENDRON TOMENTOSUM ROOT; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; PULSATILLA PRATENSIS; SAW PALMETTO 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1326_ea9f5f40-ae06-407a-9359-a05878339e72 53346-1326 HUMAN OTC DRUG DR. RECKEWEG R26 Remisin Combination Product Calcarea iodata 12X, Ferrum iodatum 12X, Nitricum acidum 12X, Phosphoricum acidum 12X, Sulphur iodatum 12X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO CALCIUM IODIDE; FERROUS IODIDE; NITRIC ACID; PHOSPHORIC ACID; SULFUR IODIDE 12; 12; 12; 12; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1327_ca9cff7d-d994-4b28-b284-1dd9f68e9eda 53346-1327 HUMAN OTC DRUG DR. RECKEWEG R27 Renocalcin Combination Product Berberis vulgaris 3X, Lycopodium clavatum 5X, Nitricum acidum 6X, Sarsaparilla 3X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO BERBERIS VULGARIS ROOT BARK; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; SMILAX REGELII ROOT 3; 5; 6; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1329_ab8af42c-ca8a-458f-9958-6a380fe8ab9a 53346-1329 HUMAN OTC DRUG DR. RECKEWEG R29 Theridon Combination Product Argentum nitricum 30X, Cocculus indicus 30X, Conium maculatum 30X, Theridion 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO SILVER NITRATE; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; THERIDION CURASSAVICUM 30; 30; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1330_ec13cadd-84f7-49bf-af16-ffc2f6a8f731 53346-1330 HUMAN OTC DRUG DR. RECKEWEG R30 Atomare Beckeron Pain relieving cream Camphora 3X, Arnica montana, radix 3X, Belladonna 3X, Calendula officinalis 3X, Dulcamara 3X, Echinacea 3X, Hamamelis virginiana 3X, Hypericum perforatum 3X, Millefolium 3X, Nux vomica 4X, Rhus toxicodendron 3X OINTMENT TOPICAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO CAMPHOR (NATURAL); ARNICA MONTANA ROOT; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 3; 3; 3; 3; 3; 3; 4; 3 [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g N 20181231 53346-1334_b3d3c578-4872-4a94-80e1-bcaf42087ed9 53346-1334 HUMAN OTC DRUG DR. RECKEWEG R34 Calcossin Combination Product Calcarea carbonica 30X, Calcarea fluorica 12X, Calcarea hypophosphorosa 6X, Calcarea phosphorica 12X, Chamomilla 6X, Hekla Lava 12X, Mercurius praecipitatus ruber 12X, Mezereum 6X, Silicea 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CALCIUM HYPOPHOSPHITE; CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE; MATRICARIA RECUTITA; HEKLA LAVA; MERCURIC OXIDE; DAPHNE MEZEREUM BARK; SILICON DIOXIDE 30; 12; 6; 12; 6; 12; 12; 6; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1335_af0d4920-b8b7-49f1-a16d-18a77032ea1b 53346-1335 HUMAN OTC DRUG DR. RECKEWEG R35 Chadontin Combination Product Aconitum napellus 6X, Bryonia 30X, Calcarea carbonica 30X, Chamomilla 4X, Colocynthis 12X, Ignatia amara 30X, Staphysagria 8X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ACONITUM NAPELLUS; BRYONIA DIOICA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; STRYCHNOS IGNATII SEED; DELPHINIUM STAPHISAGRIA SEED 6; 30; 30; 4; 12; 30; 8 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1337_c6d67ab3-1dfb-47b9-ab30-98b3daa41391 53346-1337 HUMAN OTC DRUG DR. RECKEWEG R37 Colinteston Combination Product Alumina 12X, Bryonia 4X, Colocynthis 4X, Lachesis mutus 30X, Lycopodium clavatum 4X, Mercurius corrosivus 8X, Nux vomica 6X, Plumbum aceticum 12X, Sulphur 12X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ALUMINUM OXIDE; BRYONIA DIOICA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD ACETATE; SULFUR 12; 4; 4; 30; 4; 8; 6; 12; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1340_df73a82e-a5b5-4ef7-bf7a-7d1cf56eeb8e 53346-1340 HUMAN OTC DRUG DR. RECKEWEG R40 Diaglukon Combination product Arsenicum album 8X, Lycopodium clavatum 30X, Natrum sulphuricum 12X, Phosphoricum acidum 12X, Secale cornutum 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; PHOSPHORIC ACID; CLAVICEPS PURPUREA SCLEROTIUM 8; 30; 12; 12; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1343_db7bf774-b2db-4786-a3f1-cddb90f3fa63 53346-1343 HUMAN OTC DRUG DR. RECKEWEG R43 Herbamine Combination product Arsenicum album 8X, Belladonna 30X, Bryonia 12X, Carbo vegetabilis 30X, Eriodictyon californicum 12X, Hypophysis suis 30X, Kali phosphoricum 30X, Natrum muriaticum 30X, Natrum sulphuricum 200X, Veratrum album 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA DIOICA ROOT; ACTIVATED CHARCOAL; ERIODICTYON CALIFORNICUM FLOWERING TOP; SUS SCROFA PITUITARY GLAND; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM SULFATE; VERATRUM ALBUM ROOT 8; 30; 12; 30; 12; 30; 30; 30; 200; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1345_a8eabc6f-e7d0-47f7-8dcb-4e06d3ab1b81 53346-1345 HUMAN OTC DRUG DR. RECKEWEG R45 Laryngin Combination product Argentum nitricum 12X, Arnica montana, radix 30X, Arum maculatum 12X, Calcarea carbonica 30X, Phosphorus 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO SILVER NITRATE; ARNICA MONTANA ROOT; ARUM MACULATUM ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS 12; 30; 12; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1346_c2f002cc-8b0b-42c4-9173-c6c48b196fb8 53346-1346 HUMAN OTC DRUG DR. RECKEWEG R46 Manurheumin Combination product Ferrum phosphoricum 12X, Lithium carbonicum 12X, Natrum sulphuricum 30X, Nux vomica 30X, Rhododendron chrysanthum 6X, Spiraea ulmaria 12X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO FERRIC PHOSPHATE; LITHIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; RHODODENDRON AUREUM LEAF; FILIPENDULA ULMARIA ROOT 12; 12; 30; 30; 6; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1347_e81995e6-218a-42e3-8ad8-446f5c3b8fd5 53346-1347 HUMAN OTC DRUG DR. RECKEWEG R47 Neuroglobin Combination product Asafoetida 12X, Coffea cruda 30X, Glonoinum 12X, Ignatia amara 30X, Lachesis mutus 30X, Moschus 12X, Pulsatilla 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ASAFETIDA; ARABICA COFFEE BEAN; NITROGLYCERIN; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; PULSATILLA PRATENSIS 12; 30; 12; 30; 30; 12; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1349_ad06cbb6-6070-4e4a-9db1-31cd14789676 53346-1349 HUMAN OTC DRUG DR. RECKEWEG R49 Rhinopulsan Combination product Arsenicum album 12X, Calcarea carbonica 30X, Kali bichromicum 12X, Mercurius solubilis 30X, Mercurius sulphuratus ruber 12X, Pulsatilla 12X, Sepia 12X, Sulphur 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; MERCURIC SULFIDE; PULSATILLA PRATENSIS; SEPIA OFFICINALIS JUICE; SULFUR 12; 30; 12; 30; 12; 12; 12; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1351_a4efbb03-6b76-43e1-b48f-3dad6098b9c9 53346-1351 HUMAN OTC DRUG DR. RECKEWEG R51 Thyreosan Combination product Belladonna 30X, Hekla Lava 12X, Iodium 30X, Lapis albus 12X, Lycopus virginicus 12X, Natrum muriaticum 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ATROPA BELLADONNA; HEKLA LAVA; IODINE; CALCIUM HEXAFLUOROSILICATE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE 30; 12; 30; 12; 12; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1353_a8d4f9f4-d892-451e-bfee-362998860c2d 53346-1353 HUMAN OTC DRUG DR. RECKEWEG R53 Comedonin Combination product Ammonium bromatum 12X, Bromium 12X, Hepar sulphuris calcareum 30X, Juglans regia 30X, Kali bromatum 12X, Ledum palustre 30X, Natrum bromatum 12X, Natrum muriaticum 200X, Placenta suis 12X, Viola tricolor 12X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO AMMONIUM BROMIDE; BROMINE; CALCIUM SULFIDE; ENGLISH WALNUT; POTASSIUM BROMIDE; LEDUM PALUSTRE TWIG; SODIUM BROMIDE; SODIUM CHLORIDE; SUS SCROFA PLACENTA; VIOLA TRICOLOR 12; 12; 30; 30; 12; 30; 12; 200; 12; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1355_cf19a354-66ec-4bbc-97af-7ee3e8786c65 53346-1355 HUMAN OTC DRUG DR. RECKEWEG R55 Rutavine Combination product Arnica montana, radix 3X, Belladonna 4X, Calendula officinalis 3X, Echinacea 3X, Hamamelis virginiana 4X, Rhus toxicodendron 6X, Ruta graveolens 6X, Symphytum officinale 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARNICA MONTANA ROOT; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 3; 4; 3; 3; 4; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1359_f531edcf-42bc-4af6-a613-74622bbab093 53346-1359 HUMAN OTC DRUG DR. RECKEWEG R59 Vesiculine Combination product Calcarea carbonica 12X, Fucus vesiculosus 4X, Graphites 12X, Natrum sulphuricum 4X, Spongia tosta 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO OYSTER SHELL CALCIUM CARBONATE, CRUDE; FUCUS VESICULOSUS; GRAPHITE; SODIUM SULFATE; SPONGIA OFFICINALIS SKELETON, ROASTED 12; 4; 12; 4; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1360_e64648de-3e94-4547-a3c0-da755755033b 53346-1360 HUMAN OTC DRUG DR. RECKEWEG R60 Purhaemine Combination product Aranea diadema 12X, Conium maculatum 30X, Fumaria officinalis 6X, Galium aparine 12X, Hepar sulphuris calcareum 12X, Juglans regia 6X, Myosotis arvensis 6X, Sarsaparilla 6X, Scrophularia nodosa 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARANEUS DIADEMATUS; CONIUM MACULATUM FLOWERING TOP; FUMARIA OFFICINALIS FLOWERING TOP; GALIUM APARINE; CALCIUM SULFIDE; ENGLISH WALNUT; MYOSOTIS ARVENSIS; SMILAX REGELII ROOT; SCROPHULARIA NODOSA 12; 30; 6; 12; 12; 6; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1363_d858c247-2068-4e99-be9a-7a2cb1ed9e8f 53346-1363 HUMAN OTC DRUG DR. RECKEWEG R63 Endangitin Combination product Aesculus hippocastanum 2X, Potentilla anserina 2X, Cuprum aceticum 6X, Secale cornutum 4X, Tabacum 4X, Veratrum album 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO HORSE CHESTNUT; POTENTILLA ANSERINA FLOWERING TOP; CUPRIC ACETATE; CLAVICEPS PURPUREA SCLEROTIUM; TOBACCO LEAF; VERATRUM ALBUM ROOT 2; 2; 6; 4; 4; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1365_cabf7ad1-d5ce-43d6-a802-24e462b7379a 53346-1365 HUMAN OTC DRUG DR. RECKEWEG R65 Psoriasin Combination Product Berberis aquifolium 4X, Hydrocotyle asiatica 4X, Arsenicum album 12X, Calcarea carbonica 30X, Graphites 12X, Natrum muriaticum 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO MAHONIA AQUIFOLIUM WHOLE; CENTELLA ASIATICA; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; SODIUM CHLORIDE 4; 4; 12; 30; 12; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1366_c6d6c6b5-fafb-4b99-b182-15da7bdcf97a 53346-1366 HUMAN OTC DRUG DR. RECKEWEG R66 Arrhythmin Combination product Ammi visnaga 2X, Cytisus scoparius 2X, Leonurus cardiaca 2X, Sumbul 2X, Iberis amara 3X, Oleander 3X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO AMMI VISNAGA FRUIT; CYTISUS SCOPARIUS FLOWERING TOP; LEONURUS CARDIACA; FERULA SUMBUL ROOT; IBERIS AMARA SEED; NERIUM OLEANDER LEAF 2; 2; 2; 2; 3; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1368_abc664bc-f816-4be9-8bce-e1f2ee502407 53346-1368 HUMAN OTC DRUG DR. RECKEWEG R68 Herpezostin Combination product Mezereum 3X, Croton tiglium 6X, Rhus toxicodendron 4X, Natrum muriaticum 6X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO DAPHNE MEZEREUM BARK; CROTON TIGLIUM SEED; TOXICODENDRON PUBESCENS LEAF; SODIUM CHLORIDE 3; 6; 4; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1371_f6236ba6-4a87-435e-b50f-836030c265ba 53346-1371 HUMAN OTC DRUG DR. RECKEWEG R71 Ischialgin Combination product Aconitum napellus 4X, Arsenicum album 30X, Colocynthis 4X, Gnaphalium polycephalum 3X, Magnesia phosphorica 8X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ACONITUM NAPELLUS; ARSENIC TRIOXIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 4; 30; 4; 3; 8 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1373_bd9bad22-e1d7-439a-83fd-1219b7e6cd87 53346-1373 HUMAN OTC DRUG DR. RECKEWEG R73 Spondarthrin Combination product Arnica montana, radix 4X, Bryonia 4X, Ledum palustre 4X, Sulphuricum acidum 6X, Argentum metallicum 12X, Causticum 12X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO ARNICA MONTANA ROOT; BRYONIA DIOICA ROOT; LEDUM PALUSTRE TWIG; SULFURIC ACID; SILVER; CAUSTICUM 4; 4; 4; 6; 12; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1374_e1b68275-cb3c-483b-ad77-f9ef08f6a599 53346-1374 HUMAN OTC DRUG DR. RECKEWEG R74 Nocturnin Combination product Ferrum phosphoricum 8X, Kali phosphoricum 12X, Pulsatilla 12X, Sepia 6X, Calcarea phosphorica 30X, Causticum 30X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO FERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA PRATENSIS; SEPIA OFFICINALIS JUICE; CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE; CAUSTICUM 8; 12; 12; 6; 30; 30 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1376_a8bc3f20-8639-40d3-8ff1-e3ddc0a0165a 53346-1376 HUMAN OTC DRUG DR. RECKEWEG R76 Herbamine Forte Combination product Drosera 1X, Mentholum 2X, Convallaria majalis 3X, Lobelia inflata 3X, Stramonium 6X, Aconitum napellus 3X, Ammi visnaga 2X, Kali iodatum 3X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO DROSERA ROTUNDIFOLIA; MENTHOL; CONVALLARIA MAJALIS; LOBELIA INFLATA; DATURA STRAMONIUM; ACONITUM NAPELLUS; AMMI VISNAGA FRUIT; POTASSIUM IODIDE 1; 2; 3; 3; 6; 3; 2; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53346-1381_f4b615cb-0f8b-4a37-9f99-b64a9b61edb9 53346-1381 HUMAN OTC DRUG DR. RECKEWEG R81 Maldol Combination product Cyclamen europaeum 4X, Ginkgo biloba 3X, Aranea diadema 4X, Cimicifuga racemosa 4X, Cocculus indicus 4X, Colocynthis 4X, Gelsemium sempervirens 3X, Spigelia anthelmia 4X LIQUID ORAL 19860601 UNAPPROVED HOMEOPATHIC PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO CYCLAMEN PURPURASCENS TUBER; GINKGO; ARANEUS DIADEMATUS; BLACK COHOSH; ANAMIRTA COCCULUS SEED; CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; SPIGELIA ANTHELMIA 4; 3; 4; 4; 4; 4; 3; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 53360-4142_fecbdf4d-7761-4945-a23c-5edcc2ed0e4d 53360-4142 HUMAN PRESCRIPTION DRUG Multaq dronedarone TABLET, FILM COATED ORAL 20090701 NDA NDA022425 Sanofi Winthrop Industries DRONEDARONE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 53389-046_acbdcb54-c4c2-47b1-ab3e-4979a9b47cb3 53389-046 HUMAN OTC DRUG EROS ANAL EASE GLYCERIN SPRAY TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL E 20171231 53389-231_ffb81ef9-bfe3-4467-a919-45bf76ec65ae 53389-231 HUMAN OTC DRUG EROS LONG STAY SILICONE GLIDE MAN DIMETHICONE GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH DIMETHICONE 30 g/100mL E 20171231 53389-241_2744e70b-4af2-462c-b35c-0d5806d440f0 53389-241 HUMAN OTC DRUG EROS AQUA BASED GLYCERIN GEL TOPICAL 20121001 OTC MONOGRAPH FINAL part347 MEGASOL COSMETIC GMBH GLYCERIN 30 g/100mL E 20171231 53401-004_71ae692b-b996-4498-b7f0-15acb582f497 53401-004 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, COATED ORAL 20091010 ANDA ANDA007581 Testpak Holding Company CIPROFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 53401-005_9770c576-1eb6-41ab-ab4d-886121391ca6 53401-005 HUMAN PRESCRIPTION DRUG ciprofloxacin hydrochloride ciprofloxacin hydrochloride TABLET, COATED ORAL 20091203 ANDA ANDA076794 Testpak Holding Company CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 53401-100_660693fd-25d3-485a-86b6-0ef4bda647ce 53401-100 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20110714 ANDA ANDA062505 Aphena Pharma Solutions (Formerly TestPak) DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 53401-200_a7295887-cfd9-4422-9395-01a77676c9f4 53401-200 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100913 ANDA ANDA077289 Aphena Pharma Solutions - New Jersey, LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53401-201_a7295887-cfd9-4422-9395-01a77676c9f4 53401-201 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100913 ANDA ANDA077289 Aphena Pharma Solutions - New Jersey, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53401-202_a7295887-cfd9-4422-9395-01a77676c9f4 53401-202 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100913 ANDA ANDA077289 Aphena Pharma Solutions - New Jersey, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53401-300_cc8b4662-82e8-41ef-a112-17c110da6b66 53401-300 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19860710 ANDA ANDA062677 Aphena Pharma Solutions - New Jersey, LLC DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 53401-301_9a9adf9b-389b-40f2-980e-38d7c5b15033 53401-301 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20090801 ANDA ANDA077859 Aphena Pharma Solutions - New Jersey, LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 53405-0001_c4d2c738-e285-4518-9455-e33924dbe76e 53405-0001 HUMAN OTC DRUG E.O.L. Stollingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Niacin Serotonin, 5-Hydroxytryptophan, Betainum Murriatium, Biotin, Cholinum, Coconut Oil, CO Q 10, DL-Methionine, L-Alanine LIQUID ORAL 20131010 UNAPPROVED HOMEOPATHIC Inlight Creation, LLC STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACIN; SEROTONIN; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; COCONUT OIL; UBIDECARENONE; RACEMETHIONINE; ALANINE; CYSTEINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; METHIONINE; SERINE; LYSINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; THYROID, PORCINE; CHOLECALCIFEROL; CRANBERRY; DOPAMINE; LITHIUM BROMIDE; SHARK CARTILAGE; SQUALENE; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; PUMPKIN SEED; LEMON JUICE; BROMELAINS; ILEX AQUIFOLIUM FRUITING TOP; MALUS SYLVESTRIS FLOWER; HORSE CHESTNUT 3; 3; 4; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 7; 8; 8; 8; 8; 12; 17; 18; 6; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 53405-0002_9afa7c0e-22e2-44cb-88c0-45aa51358f66 53405-0002 HUMAN OTC DRUG E.O.L. Stillingia Sylvatica, Zincum Gluconicum, Fragaria Vesca, Niacin, Serotonin, 5-Hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, CO Q 10, DL-Methionine, L-Alanine, L-Cysteine, L-Cystine, L-Glutamic Acid LIQUID ORAL 20131021 UNAPPROVED HOMEOPATHIC InLight Creations, LLC STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACIN; SEROTONIN; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; RACEMETHIONINE; ALANINE; CYSTEINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; METHIONINE; SERINE; LYSINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; CHOLECALCIFEROL; DOPAMINE; LITHIUM BROMIDE; SHARK CARTILAGE; SQUALENE; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; COCONUT OIL; PUMPKIN SEED; LEMON JUICE; BROMELAINS; MALUS SYLVESTRIS FLOWER; ILEX AQUIFOLIUM FRUITING TOP; HORSE CHESTNUT 3; 3; 4; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 17; 18; 6; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 53405-0003_47c8ff0b-b0bb-4be2-91f8-8a85be2cfc52 53405-0003 HUMAN OTC DRUG E.O.L. Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Niacin, Serotonin, 5-Hydroxtryptophan, Betainum Muriaticum, Biotin, Cholinum, Co-Enzyme Q-10, DL-Methionine, L-Alanine, Cysteinum, LIQUID ORAL 20131023 UNAPPROVED HOMEOPATHIC InLight Creation, LLC STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACIN; SEROTONIN HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; RACEMETHIONINE; ALANINE; CYSTEINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; METHIONINE; SERINE; LYSINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; CHOLECALCIFEROL; CRANBERRY; DOPAMINE; LITHIUM BROMIDE; SHARK CARTILAGE; SQUALENE; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; COCONUT OIL; PUMPKIN SEED; LEMON JUICE; BROMELAINS; MALUS DOMESTICA FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; HORSE CHESTNUT 3; 3; 4; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 17; 18; 6; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 53405-0004_407c55c6-5ed4-4d2c-83d9-6d6a7a5d6663 53405-0004 HUMAN OTC DRUG E.O.L. Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vescus, Niacin, Serotonin (Hydrochloride), 5-Hydroxytryptophan, Betainum Muriaticum LIQUID ORAL 20140707 UNAPPROVED HOMEOPATHIC InLight Creation, LLC. STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACIN; SEROTONIN HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; CYSTEINE; RACEMETHIONINE; ALANINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; LYSINE; METHIONINE; SERINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; THYROID, PORCINE; CHOLECALCIFEROL; CRANBERRY; DOPAMINE HYDROCHLORIDE; LITHIUM BROMIDE; SHARK CARTILAGE; SQUALENE; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; COCONUT OIL; CANDIDA ALBICANS; PUMPKIN SEED; LEMON JUICE; BROMELAINS; AESCULUS HIPPOCASTANUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER 3; 3; 4; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 12; 17; 18; 6; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 53405-0005_a2eea22e-f4ec-4a55-8db5-f6bafed0e0e6 53405-0005 HUMAN OTC DRUG E.O.L. Rosa Canina, Flos, Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Nicotinamidum, Rheum (Officinale), Serotonin (Hydrochloride), 5-Hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, Cysteinum, DL-Methionine, L-Alanine, L-Cystine, L-Glutamic Acid, L-Glutamine, L-Lysine, L-Methionine, L-Serine, Oxytocin Acetate, Para-Aminobenzoic Acid, Potassium Gluconate, Thymus (Suis), Thyroidinum (Suis), Ubidecarenonum, Vitamin D3, Dopamine Hydrochloride, Lithium Bromatum, Squalene SPRAY ORAL 20170817 UNAPPROVED HOMEOPATHIC InLight Creation, LLC. ROSA CANINA FLOWER; STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; RHEUM OFFICINALE ROOT; SEROTONIN HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; CYSTEINE; RACEMETHIONINE; ALANINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; LYSINE; METHIONINE; SERINE; OXYTOCIN ACETATE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; CHOLECALCIFEROL; DOPAMINE HYDROCHLORIDE; LITHIUM BROMIDE; SQUALENE; CRANBERRY; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; CANDIDA ALBICANS; PUMPKIN SEED; LEMON JUICE; HIPPEASTRUM PUNICEUM WHOLE; BROMELAINS; AESCULUS HIPPOCASTANUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER 3; 3; 3; 4; 5; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 17; 18; 3; 6; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 53405-0007_6c0a40af-c2f0-4ecf-8fd4-d5496eac3b4e 53405-0007 HUMAN OTC DRUG E.O.L. Rosa Canina, Flos, Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Nicotinamidum, Rheum (Officinale), Serotonin (Hydrochloride), 5-Hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, Cysteinum, DL-Methionine, L-Alanine, L-Cystine, L-Glutamic Acid, L-Glutamine, L-Lysine, L-Methionine, L-Serine, Oxytocin Acetate, Para-Aminobenzoic Acid, Potassium Gluconate, Thymus (Suis), Thyroidinum (Suis), Ubidecarenonum, Vitamin D3, Dopamine Hydrochloride, Lithium Bromatum, Squalene SPRAY ORAL 20170822 UNAPPROVED HOMEOPATHIC InLight Creation, LLC. ROSA CANINA FLOWER; STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; ALPINE STRAWBERRY; NIACINAMIDE; RHEUM OFFICINALE ROOT; SEROTONIN HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; CYSTEINE; RACEMETHIONINE; ALANINE; CYSTINE; GLUTAMIC ACID; GLUTAMINE; LYSINE; METHIONINE; SERINE; OXYTOCIN ACETATE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; SUS SCROFA THYROID; CHOLECALCIFEROL; DOPAMINE HYDROCHLORIDE; LITHIUM BROMIDE; SQUALENE; CRANBERRY; COPPER; PHENYLALANINE; SELENIUM DIOXIDE; SELENIUM; BORRELIA BURGDORFERI; COCONUT OIL; CANDIDA ALBICANS; PUMPKIN SEED; LEMON JUICE; HIPPEASTRUM PUNICEUM WHOLE; BROMELAINS; AESCULUS HIPPOCASTANUM FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER 3; 3; 3; 4; 5; 5; 5; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 7; 7; 7; 8; 8; 8; 8; 12; 12; 12; 17; 18; 3; 6; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 53407-104_832dd2f9-b7a0-448d-ae64-74dc01d5fe3e 53407-104 HUMAN OTC DRUG Algenist Avobenzone, Homosalate, Octisalate CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Solazyme, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE 30; 80; 50 mg/mL; mg/mL; mg/mL E 20171231 53407-138_a060dff3-d195-41fc-8b67-8bd9a162fbc7 53407-138 HUMAN OTC DRUG Algenist Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Solazyme, Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 20; 171 mg/mL; mg/mL; mg/mL E 20171231 53407-155_ce6c13f4-9b9f-415f-9a3f-0b8b8cad7c50 53407-155 HUMAN OTC DRUG Algenist Avobenzone, Homosalate, Octisalate CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Solazyme, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE 30; 80; 50 mg/mL; mg/mL; mg/mL E 20171231 53407-170_3bfc49a6-0213-4f1d-93a5-6c2999fe89b8 53407-170 HUMAN OTC DRUG SUBLIME DEFENSE Anti-Aging Blurring Moisturizer SPF 30 Octinoxate and Zinc Oxide LOTION TOPICAL 20150316 OTC MONOGRAPH NOT FINAL part352 Terravia, Inc. OCTINOXATE; ZINC OXIDE 1.5; 6 g/60mL; g/60mL E 20171231 53413-752_396a2c91-dd8c-4aba-949e-2b4828e30521 53413-752 HUMAN PRESCRIPTION DRUG P-Bloc Sarraceniaceae INJECTION PARENTERAL 20041120 UNAPPROVED DRUG OTHER Creative Science, LLC SARRACENIA PURPUREA 12.5 mg/mL N 20181231 53425-001_b1134674-c30e-42b5-b13f-1c59afa6a811 53425-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100719 NDA NDA205712 IWS Gas and Supply of Texas, LTD OXYGEN 995 mL/L N 20181231 53425-002_2f8b4ce7-0239-4b9c-a44f-b56190527257 53425-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20111101 NDA NDA205713 IWS Gas and Supply of Texas, LTD NITROGEN 995 mL/L N 20181231 53436-084_889a47fe-9cc1-49dd-b97c-63b328399eaa 53436-084 HUMAN PRESCRIPTION DRUG VELTASSA patiromer POWDER, FOR SUSPENSION ORAL 20151023 NDA NDA205739 Relypsa, Inc. PATIROMER 8.4 g/1 Potassium Binder [EPC],Potassium Ion Binding Activity [MoA] N 20181231 53436-168_889a47fe-9cc1-49dd-b97c-63b328399eaa 53436-168 HUMAN PRESCRIPTION DRUG VELTASSA patiromer POWDER, FOR SUSPENSION ORAL 20151023 NDA NDA205739 Relypsa, Inc. PATIROMER 16.8 g/1 Potassium Binder [EPC],Potassium Ion Binding Activity [MoA] N 20181231 53436-252_889a47fe-9cc1-49dd-b97c-63b328399eaa 53436-252 HUMAN PRESCRIPTION DRUG VELTASSA patiromer POWDER, FOR SUSPENSION ORAL 20151023 NDA NDA205739 Relypsa, Inc. PATIROMER 25.2 g/1 Potassium Binder [EPC],Potassium Ion Binding Activity [MoA] N 20181231 53439-100_cda8f72f-d34c-4a2d-8762-24ff2717311b 53439-100 HUMAN OTC DRUG Cut Care Alcohol Prep Pad Isopropyl alcohol SWAB TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333A Zeus Medical Holdings LLC ISOPROPYL ALCOHOL .7 mL/1 E 20171231 53439-120_cc58d0da-6bde-49eb-b3df-fd6a542939dd 53439-120 HUMAN OTC DRUG Cut Care Insect Bite Antiseptic and Pain Relieving Wipe Benzocaine and Isopropyl Alcohol SWAB TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part348 Zeus Medical Holdings LLC BENZOCAINE; ISOPROPYL ALCOHOL .021; .7 g/1; mL/1 E 20171231 53439-130_f1633a33-a170-441d-a74f-304b0993807d 53439-130 HUMAN OTC DRUG Cut Care Benzalkonium Chloride Antiseptic Benzalkonium Chloride SWAB TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333A Zeus Medical Holdings LLC BENZALKONIUM CHLORIDE 1.3 mg/1 E 20171231 53440-001_635ed0d2-45d1-4304-e053-2a91aa0ae121 53440-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000101 NDA NDA205767 Westair Gases & Equipment, Inc. OXYGEN 995 mL/L N 20191231 53440-002_635e9537-a2bf-3465-e053-2991aa0ac7f7 53440-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20000101 NDA NDA205766 Westair Gases & Equipment, Inc. NITROGEN 995 mL/L N 20191231 53440-003_635e9537-a2c2-3465-e053-2991aa0ac7f7 53440-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20000101 NDA NDA206009 Westair Gases & Equipment, Inc. NITROUS OXIDE 995 mL/L N 20191231 53440-004_635e9537-a2ba-3465-e053-2991aa0ac7f7 53440-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20000101 NDA NDA205764 Westair Gases & Equipment, Inc. CARBON DIOXIDE 995 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20191231 53440-005_e999faac-e682-4b59-80ec-71e7d108af19 53440-005 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20000101 UNAPPROVED MEDICAL GAS WestAir Gases & Equipment, Inc. AIR 995 mL/L E 20171231 53440-006_5b061e38-3d49-44fd-bc6f-504a607e9dc4 53440-006 HUMAN PRESCRIPTION DRUG Carbogen Carbogen GAS RESPIRATORY (INHALATION) 20000101 UNAPPROVED MEDICAL GAS WestAir Gases and Equipment, Inc. CARBON DIOXIDE; OXYGEN 5; 95 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 53440-007_635e9537-a2b8-3465-e053-2991aa0ac7f7 53440-007 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20000101 NDA NDA205767 Westair Gases & Equipment, Inc. OXYGEN 995 mL/L N 20191231 53440-008_635e9537-a2c6-3465-e053-2991aa0ac7f7 53440-008 HUMAN PRESCRIPTION DRUG Carbogen Carbogen GAS RESPIRATORY (INHALATION) 20000101 NDA NDA205767 Westair Gases & Equipment, Inc. OXYGEN 950 mL/L N 20191231 53441-251_1111ed8b-ec9b-4066-bfc6-78c6691efd57 53441-251 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 20140530 OTC MONOGRAPH FINAL part340 National Distribution Network (Smart Choice) CAFFEINE 200 mg/1 N 20181231 53441-268_56ff6532-ffd2-48e2-9f7b-4da6c135eac8 53441-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part356 National Distribution Network (Smart Choice) HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 53441-275_dca3f67d-3262-4f62-925e-2b0b188ba6eb 53441-275 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A National Distribution Network (Smart Choice) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 53441-311_7b24af92-7228-4fd2-a192-d69244edadbd 53441-311 HUMAN OTC DRUG Day Time Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 National Distribution Network (Smart Choice) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 53441-342_f2294088-06a1-4971-84bc-0277af26157e 53441-342 HUMAN OTC DRUG Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140630 20190630 OTC MONOGRAPH FINAL part341 National Distribution Network (Smart Choice) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 53441-343_24326bcd-281c-4924-b3c4-84937d71d80f 53441-343 HUMAN OTC DRUG Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 National Distribution Network (Smart Choice) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 53441-344_c0dc2860-af72-49f8-90ff-3c6ceb499a9b 53441-344 HUMAN OTC DRUG Night Time Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 National Distribution Network (Smart Choice) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 53441-346_9da850a8-733b-44c2-86eb-2af250884f44 53441-346 HUMAN OTC DRUG Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 National Distribution Network (Smart Choice) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 53441-630_92d1b930-dcb5-4c54-9ed9-d59642c9f3ca 53441-630 HUMAN OTC DRUG Motion Sickness Original Formula Dimenhydrinate TABLET ORAL 20140630 OTC MONOGRAPH FINAL part336 National Distribution Network (Smart Choice) DIMENHYDRINATE 50 mg/1 N 20181231 53441-670_e66ebfea-c2cd-46d9-b6e5-ab9b48a01581 53441-670 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20140630 OTC MONOGRAPH FINAL part341 National Distribution Network (Smart Choice) PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 53448-0001_92355b64-e36c-40c5-9aa2-788bfda72ba5 53448-0001 HUMAN OTC DRUG Psoriasis Skin Cream Berberis Aquifolium, Calendula Officinalis, Hydrocotyle Asiatica, Thuja Occidentalis, Borax, Natrum Muriaticum CREAM TOPICAL 20130425 UNAPPROVED HOMEOPATHIC Natural Products Ctr MAHONIA AQUIFOLIUM ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; CENTELLA ASIATICA; THUJA OCCIDENTALIS LEAF; SODIUM BORATE; SODIUM CHLORIDE; TETRAARSENIC TETRASULFIDE; TURMERIC; AZADIRACHTA INDICA BARK 1; 3; 3; 3; 8; 8; 12; 12; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g N 20181231 53451-0101_58396e1f-c1f4-460b-af3e-30827f69cc24 53451-0101 HUMAN PRESCRIPTION DRUG Horizant gabapentin enacarbil TABLET, EXTENDED RELEASE ORAL 20130501 NDA NDA022399 Arbor Pharmaceuticals GABAPENTIN ENACARBIL 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53451-0103_58396e1f-c1f4-460b-af3e-30827f69cc24 53451-0103 HUMAN PRESCRIPTION DRUG Horizant gabapentin enacarbil TABLET, EXTENDED RELEASE ORAL 20130501 NDA NDA022399 Arbor Pharmaceuticals GABAPENTIN ENACARBIL 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53452-001_5997d1fa-baef-4122-b02c-cc94c5049f04 53452-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19630101 NDA NDA205767 Dale Oxygen And Acetylene Service, Inc OXYGEN 990 mL/L N 20181231 53452-002_d4e6fe24-3052-4fa3-9189-132a815a3190 53452-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19630101 NDA NDA205766 Dale Oxygen And Acetylene Service, Inc NITROGEN 990 mL/L N 20181231 53452-003_5df1db83-1d7c-47ba-bfd8-acd0e1a28575 53452-003 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19630101 NDA NDA205767 Dale Oxygen And Acetylene Service, Inc OXYGEN 210 mL/L N 20181231 53462-003_3c754532-d9a5-f876-00c4-05a4c9b21efa 53462-003 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate 0.12% Oral Rinse CHLORHEXIDINE GLUCONATE LIQUID BUCCAL 20140120 ANDA ANDA077789 Sage Products LLC CHLORHEXIDINE GLUCONATE 1.2 [iU]/mL Decreased Cell Wall Integrity [PE] N 20181231 53462-006_60261da2-0d10-6742-e053-2a91aa0a9664 53462-006 HUMAN OTC DRUG Daily Oral Cleansing Kit Petite Size with Antiseptic Oral Rinse Cetylpyridinium chloride KIT 20060630 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-007_0f07c40c-0c16-48da-a265-fdda3ceb2736 53462-007 HUMAN OTC DRUG Skin antisepsis, oral cleansing, nasal antisepsis CHLORHEXIDINE GLUCONATE KIT 20120206 NDA NDA021669 Sage Products, Inc. N 20181231 53462-008_d36bf0aa-9dec-3328-cab8-8fc6748dafb3 53462-008 HUMAN OTC DRUG Skin antisepsis, oral cleansing, nasal antisepsis CHLORHEXIDINE GLUCONATE KIT 20120206 NDA NDA021669 Sage Products, Inc. N 20181231 53462-009_47f2f833-bef1-0c95-e054-00144ff88e88 53462-009 HUMAN OTC DRUG Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System CHLORHEXIDINE GLUCONATE KIT 20161228 NDA NDA021669 Sage Products, LLC N 20181231 53462-011_61729c06-cd2e-6373-e053-2a91aa0ad363 53462-011 HUMAN OTC DRUG Short Term Oral Swab System Hydrogen Peroxide KIT 20020628 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-014_5fc2f931-6c82-0ffc-e053-2a91aa0a54db 53462-014 HUMAN OTC DRUG QCare Petite Size Oral Cleansing and Suctioning System CETYLPYRIDINIUM CHLORIDE KIT 20171026 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-023_61729c06-cd3d-6373-e053-2a91aa0ad363 53462-023 HUMAN OTC DRUG Short Term Oral Swab System Hydrogen Peroxide KIT 20070630 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC N 20181231 53462-024_4752b940-f918-5199-e054-00144ff8d46c 53462-024 HUMAN OTC DRUG Short Term Oral Care System Hydrogen Peroxide KIT 20161019 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-075_617e2da0-2980-c7d6-e053-2a91aa0addf1 53462-075 HUMAN OTC DRUG Perox-A-Mint Solution HYDROGEN PEROXIDE MOUTHWASH BUCCAL 19980521 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC HYDROGEN PEROXIDE 15 mg/mL N 20181231 53462-110_47f315d7-002d-0030-e054-00144ff8d46c 53462-110 HUMAN OTC DRUG Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System CHLORHEXIDINE GLUCONATE KIT 20161228 NDA NDA021669 Sage Products, LLC N 20181231 53462-113_4899848f-432b-4e6e-e054-00144ff88e88 53462-113 HUMAN OTC DRUG Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer Cetylpyridinium chloride KIT 20061230 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-120_816c614e-b914-ce70-3823-e8469e45dbd7 53462-120 HUMAN OTC DRUG Toothette Oral Care Single Use System with Antiseptic Oral Rinse HYDROGEN PEROXIDE KIT 20130331 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-175_5fd9ebd5-c7cb-5a31-e053-2a91aa0a63d0 53462-175 HUMAN OTC DRUG Antiseptic Oral Rinse CETYLPYRIDINIUM CHLORIDE MOUTHWASH BUCCAL 20000621 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC CETYLPYRIDINIUM CHLORIDE .5 mg/mL N 20181231 53462-201_61726afb-dd3e-12bd-e053-2a91aa0ab27e 53462-201 HUMAN OTC DRUG Short Term Oral Swab System Hydrogen Peroxide KIT 20070630 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC N 20181231 53462-212_4894b751-9195-0fb5-e054-00144ff8d46c 53462-212 HUMAN OTC DRUG Single Use System with Perox-A-Mint solution Hydrogen Peroxide KIT 20010628 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-215_48ab99cf-e32b-49f6-e054-00144ff88e88 53462-215 HUMAN OTC DRUG Suction Swab System Cetylpyridinium chloride KIT 20061230 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-273_48fa3c63-bb6a-284c-e054-00144ff88e88 53462-273 HUMAN OTC DRUG Suction Toothbrushes Cetylpyridinium chloride KIT 20060630 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-275_6015b511-33b0-a159-e053-2a91aa0a6066 53462-275 HUMAN OTC DRUG Antiplaque solution CETYLPYRIDINIUM CHLORIDE MOUTHWASH BUCCAL 20090109 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC CETYLPYRIDINIUM CHLORIDE .5 mg/mL N 20181231 53462-306_77cd666b-f9c1-4d44-b1c8-6de5cc1d299d 53462-306 HUMAN OTC DRUG QCare CETYLPYRIDINIUM CHLORIDE KIT 20011228 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-308_77cd666b-f9c1-4d44-b1c8-6de5cc1d299d 53462-308 HUMAN OTC DRUG QCare CETYLPYRIDINIUM CHLORIDE KIT 20011228 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-375_617bc45f-e989-640f-e053-2991aa0aced3 53462-375 HUMAN OTC DRUG Corinz Cetylpyridinium Chloride RINSE ORAL 20150120 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC CETYLPYRIDINIUM CHLORIDE .5 mg/mL N 20181231 53462-404_49afd9e4-7538-3b42-e054-00144ff8d46c 53462-404 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System Q4 Antiseptic Oral Rinse CETYLPYRIDINIUM CHLORIDE KIT 20050630 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-412_49af17f1-138e-1662-e054-00144ff8d46c 53462-412 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System Q2 CETYLPYRIDINIUM CHLORIDE KIT 20060630 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-414_49afd9e4-7538-3b42-e054-00144ff8d46c 53462-414 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System Q4 Antiseptic Oral Rinse CETYLPYRIDINIUM CHLORIDE KIT 20060630 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-424_617f4fd2-a4f7-5ff5-e053-2991aa0a2003 53462-424 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System, Q4 CETYLPYRIDINIUM CHLORIDE and HYDROGEN PEROXIDE KIT 20080630 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC N 20181231 53462-426_617f4fd2-a4f7-5ff5-e053-2991aa0a2003 53462-426 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System, Q4 CETYLPYRIDINIUM CHLORIDE and HYDROGEN PEROXIDE KIT 20130801 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC N 20181231 53462-462_08560105-d7fc-334e-08a1-73c0f1f93b7b 53462-462 HUMAN OTC DRUG QCARE ORAL CLEANSING AND SUCTIONING SYSTEM CETYLPYRIDINIUM CHLORIDE KIT 20160111 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-464_08560105-d7fc-334e-08a1-73c0f1f93b7b 53462-464 HUMAN OTC DRUG QCARE ORAL CLEANSING AND SUCTIONING SYSTEM CETYLPYRIDINIUM CHLORIDE KIT 20160111 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-502_602708af-387f-cea4-e053-2a91aa0aac73 53462-502 HUMAN OTC DRUG Oral Cleansing and Suctioning System, Q2 CETYLPYRIDINIUM CHLORIDE and HYDROGEN PEROXIDE KIT 20130801 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-504_207b8fdf-4f03-69b8-4621-b8054b7ae6a6 53462-504 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System, Q4 CETYLPYRIDINIUM CHLORIDE and HYDROGEN PEROXIDE KIT 19980521 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-553_49d7cafc-f034-6aa1-e054-00144ff8d46c 53462-553 HUMAN OTC DRUG Suction Swab System with Perox-A-Mint Solution - Suction Swab and Suction Toothbrush Hydrogen Peroxide KIT 20070630 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-571_617f1233-c0c5-fe4e-e053-2991aa0a82a7 53462-571 HUMAN OTC DRUG Suction Toothbrushes with Perox-A-Mint Solution HYDROGEN PEROXIDE KIT 20070630 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-572_617f1233-c0c5-fe4e-e053-2991aa0a82a7 53462-572 HUMAN OTC DRUG Suction Toothbrush with Perox-A-Mint Solution HYDROGEN PEROXIDE KIT 20030630 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-592_3b467496-dde7-6c24-418f-68843a8acce5 53462-592 HUMAN OTC DRUG Oral Cleansing and Suctioning System, q2 CHLORHEXIDINE GLUCONATE and HYDROGEN PEROXIDE KIT 20140701 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-594_617271ba-eb00-f9d8-e053-2a91aa0a28d5 53462-594 HUMAN OTC DRUG Oral Cleansing and Suctioning System, q4 CHLORHEXIDINE GLUCONATE and HYDROGEN PEROXIDE KIT 20140701 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC N 20181231 53462-614_617f211e-1d13-2ad8-e053-2991aa0a0a17 53462-614 HUMAN OTC DRUG Suction Swabs with Perox-A-Mint Solution Hydrogen Peroxide KIT 20071231 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-650_49d7cafc-f034-6aa1-e054-00144ff8d46c 53462-650 HUMAN OTC DRUG Suction Swab System with Perox-A-Mint Solution - Suction Swab Hydrogen Peroxide KIT 20020628 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-674_61834dc7-f7ba-1a53-e053-2991aa0a4d98 53462-674 HUMAN OTC DRUG Suction Toothbrush with Antiseptic Oral Rinse Cetylpyridinium chloride KIT 20071231 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC N 20181231 53462-702_617cf7fb-c527-51c8-e053-2a91aa0a66a9 53462-702 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System HYDROGEN PEROXIDE KIT 20040630 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC N 20181231 53462-704_4757545f-e9e1-3a88-e054-00144ff8d46c 53462-704 HUMAN OTC DRUG QCare Petite Size Oral Cleansing and Suctioning System CETYLPYRIDINIUM CHLORIDE KIT 20040630 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-705_5acfae1a-422d-3871-e053-2991aa0a9cee 53462-705 HUMAN OTC DRUG CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE CLOTH TOPICAL 20060201 NDA NDA021669 Sage Products LLC CHLORHEXIDINE GLUCONATE 500 mg/1 N 20181231 53462-714_61729c06-cd4c-6373-e053-2a91aa0ad363 53462-714 HUMAN OTC DRUG QCare Petite Size Oral Cleansing and Suctioning System CETYLPYRIDINIUM CHLORIDE KIT 20130402 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC N 20181231 53462-772_617f1233-c0c5-fe4e-e053-2991aa0a82a7 53462-772 HUMAN OTC DRUG Suction Toothbrush with Perox-A-Mint Solution HYDROGEN PEROXIDE KIT 20070630 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-804_617d7e1c-16a4-4104-e053-2991aa0a7e9e 53462-804 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System, Q4 CETYLPYRIDINIUM CHLORIDE and HYDROGEN PEROXIDE KIT 20040630 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-808_617d7e1c-16a4-4104-e053-2991aa0a7e9e 53462-808 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System, Q8 CETYLPYRIDINIUM CHLORIDE and HYDROGEN PEROXIDE KIT 20040630 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-812_617f211e-1d13-2ad8-e053-2991aa0a0a17 53462-812 HUMAN OTC DRUG Suction Swabs with Perox-A-Mint Solution Hydrogen Peroxide KIT 20020628 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-813_617f211e-1d13-2ad8-e053-2991aa0a0a17 53462-813 HUMAN OTC DRUG Suction Swabs with Perox-A-Mint Solution Hydrogen Peroxide KIT 20020628 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-904_21eb36ec-b44c-93e7-3547-2d68ce31b44b 53462-904 HUMAN OTC DRUG QCare Rx Oral Cleansing and Suctioning System, Q4 CHLORHEXIDINE GLUCONATE and HYDROGEN PEROXIDE KIT 20071231 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-915_6171d1df-ae4a-4a62-e053-2a91aa0a7958 53462-915 HUMAN OTC DRUG Comfort Shield Barrier dimethicone CLOTH TOPICAL 19900101 OTC MONOGRAPH FINAL part347 Sage Products LLC DIMETHICONE 30 mg/g N 20181231 53462-922_e8d23d6a-3828-8c4c-1561-287bab6cb834 53462-922 HUMAN OTC DRUG QCare Rx Oral Cleansing and Suctioning System, Q2 CHLORHEXIDINE GLUCONATE and HYDROGEN PEROXIDE KIT 20071231 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-924_21843493-2870-a8ca-7be1-424237830f98 53462-924 HUMAN OTC DRUG QCare Rx Oral Cleansing and Suctioning System, Q4 CHLORHEXIDINE GLUCONATE and HYDROGEN PEROXIDE KIT 20071231 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-926_61720c01-f401-823b-e053-2991aa0ad492 53462-926 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System, Q2 HYDROGEN PEROXIDE KIT 20140301 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC N 20181231 53462-927_61726afb-dd4d-12bd-e053-2a91aa0ab27e 53462-927 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System, Q4 HYDROGEN PEROXIDE KIT 20140301 OTC MONOGRAPH NOT FINAL part356 Sage Products, LLC N 20181231 53462-932_e7e9802d-c8b2-f0cb-6a81-56019e13dbf7 53462-932 HUMAN OTC DRUG QCare Rx Oral Cleansing and Suctioning System CHLORHEXIDINE GLUCONATE and HYDROGEN PEROXIDE KIT 20071231 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-944_e9b79ccd-1e9c-df87-1046-0af763e73089 53462-944 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System Q4 Antiseptic Oral Rinse CETYLPYRIDINIUM CHLORIDE KIT 20150601 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-962_c19efc08-23c2-7cf4-c1a8-f072e43332b9 53462-962 HUMAN OTC DRUG QCare Rx Oral Cleansing and Suctioning System chlorhexidine gluconate and cetylpyridinium chloride KIT 20160111 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-964_c19efc08-23c2-7cf4-c1a8-f072e43332b9 53462-964 HUMAN OTC DRUG QCare Rx Oral Cleansing and Suctioning System chlorhexidine gluconate and cetylpyridinium chloride KIT 20160111 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-971_47a73774-0e7b-4954-e054-00144ff88e88 53462-971 HUMAN OTC DRUG Suction Toothbrush with Perox-A-Mint Solution Hydrogen Peroxide KIT 20160913 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-974_4392d593-ea1d-1ce4-e054-00144ff88e88 53462-974 HUMAN OTC DRUG QCare Rx Petite Oral Cleansing and Suctioning System chlorhexidine gluconate and cetylpyridinium chloride KIT 20161021 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53462-994_44308981-28ac-4f74-e054-00144ff88e88 53462-994 HUMAN OTC DRUG QCare Oral Cleansing and Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse CETYLPYRIDINIUM CHLORIDE KIT 20161116 OTC MONOGRAPH NOT FINAL part356 Sage Products LLC N 20181231 53489-110_cdfbe64d-ba89-4cb7-bc1a-3bfaadd0258c 53489-110 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19911017 ANDA ANDA089346 Mutual Pharmaceutical Company, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV E 20171231 53489-118_8ccc7b27-7fcf-475d-81a2-c4b6e5d2869b 53489-118 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19860710 ANDA ANDA062676 Sun Pharmaceutical Industries, Inc. DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 53489-119_8ccc7b27-7fcf-475d-81a2-c4b6e5d2869b 53489-119 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19860710 ANDA ANDA062676 Sun Pharmaceutical Industries, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 53489-120_8ccc7b27-7fcf-475d-81a2-c4b6e5d2869b 53489-120 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19860710 ANDA ANDA062677 Sun Pharmaceutical Industries, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 53489-141_28dc9e8c-022f-4f7e-86e3-bb18e4666779 53489-141 HUMAN PRESCRIPTION DRUG Quinidine Gluconate Quinidine Gluconate TABLET, EXTENDED RELEASE ORAL 19870210 ANDA ANDA089338 Sun Pharmaceutical Industries, Inc. QUINIDINE GLUCONATE 324 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 53489-143_647bea8b-c67b-46c3-9f0a-281ee648ebb7 53489-143 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 19860723 ANDA ANDA089424 Sun Pharmaceutical Industries, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 53489-144_135b2325-aebc-4719-adb9-5b95263f86fd 53489-144 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide TABLET ORAL 19870702 ANDA ANDA089534 Sun Pharmaceutical Industries, Inc. SPIRONOLACTONE; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 53489-145_e96fecf4-be0f-46a4-aee2-a193d145aeeb 53489-145 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19860825 ANDA ANDA071017 Sun Pharmaceutical Industries, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 53489-146_e96fecf4-be0f-46a4-aee2-a193d145aeeb 53489-146 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19860825 ANDA ANDA071017 Sun Pharmaceutical Industries, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 53489-148_2c96c6f9-3008-48ba-86ea-e9b83502da67 53489-148 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride Thioridazine Hydrochloride TABLET, FILM COATED ORAL 19881007 ANDA ANDA089953 Sun Pharmaceutical Industries, Inc. THIORIDAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53489-149_2c96c6f9-3008-48ba-86ea-e9b83502da67 53489-149 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride Thioridazine Hydrochloride TABLET, FILM COATED ORAL 19881007 ANDA ANDA089953 Sun Pharmaceutical Industries, Inc. THIORIDAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53489-150_2c96c6f9-3008-48ba-86ea-e9b83502da67 53489-150 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride Thioridazine Hydrochloride TABLET, FILM COATED ORAL 19881007 ANDA ANDA089953 Sun Pharmaceutical Industries, Inc. THIORIDAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53489-156_461b589b-66f4-4b4b-af1b-ff73d155659b 53489-156 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19870109 ANDA ANDA071450 Sun Pharmaceutical Industries, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 53489-157_461b589b-66f4-4b4b-af1b-ff73d155659b 53489-157 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19870109 ANDA ANDA071450 Sun Pharmaceutical Industries, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 53489-159_57ee1a9a-25d6-41ea-b86c-b9cc5a8cebe6 53489-159 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE Acetaminophen and Codeine Phosphate TABLET ORAL 19880210 ANDA ANDA089671 Mutual Pharmaceutical Company, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 53489-160_57ee1a9a-25d6-41ea-b86c-b9cc5a8cebe6 53489-160 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE Acetaminophen and Codeine Phosphate TABLET ORAL 19880210 ANDA ANDA089672 Mutual Pharmaceutical Company, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 53489-161_57ee1a9a-25d6-41ea-b86c-b9cc5a8cebe6 53489-161 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE Acetaminophen and Codeine Phosphate TABLET ORAL 19880210 ANDA ANDA089673 Mutual Pharmaceutical Company, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 53489-176_045940e0-0bd3-46b0-81e6-e1fb03b19757 53489-176 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 19891205 ANDA ANDA072637 Sun Pharmaceutical Industries, Inc. ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 53489-177_045940e0-0bd3-46b0-81e6-e1fb03b19757 53489-177 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 19891205 ANDA ANDA072637 Sun Pharmaceutical Industries, Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 53489-215_c0fc5006-ac11-423d-b189-7e95f5fe8d99 53489-215 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 Mutual Pharmaceutical Company, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53489-216_c0fc5006-ac11-423d-b189-7e95f5fe8d99 53489-216 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070924 Mutual Pharmaceutical Company, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53489-217_c0fc5006-ac11-423d-b189-7e95f5fe8d99 53489-217 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070923 Mutual Pharmaceutical Company, Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53489-281_273c1270-5303-44f5-be30-0c779d88fea1 53489-281 HUMAN PRESCRIPTION DRUG Ergoloid Mesylates Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine mesylate, and Dihydro-.beta.-ergocryptine mesylate TABLET ORAL 19911031 ANDA ANDA081113 Sun Pharmaceutical Industries, Inc. DIHYDROERGOCORNINE MESYLATE; DIHYDROERGOCRISTINE MESYLATE; DIHYDRO-.ALPHA.-ERGOCRYPTINE MESYLATE; DIHYDRO-.BETA.-ERGOCRYPTINE MESYLATE .333; .333; .222; .111 mg/1; mg/1; mg/1; mg/1 N 20181231 53489-328_647bea8b-c67b-46c3-9f0a-281ee648ebb7 53489-328 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 Sun Pharmaceutical Industries, Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 53489-329_647bea8b-c67b-46c3-9f0a-281ee648ebb7 53489-329 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 Sun Pharmaceutical Industries, Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 53489-330_61574704-d4f9-8b85-e053-2991aa0aa535 53489-330 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 20201231 ANDA ANDA081048 Sun Pharmaceutical Industries, Inc. IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 53489-331_61574704-d4f9-8b85-e053-2991aa0aa535 53489-331 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 20201231 ANDA ANDA081049 Sun Pharmaceutical Industries, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 53489-332_61574704-d4f9-8b85-e053-2991aa0aa535 53489-332 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 20201231 ANDA ANDA081050 Sun Pharmaceutical Industries, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 53489-368_8a8316fb-fb67-4618-bd56-977c38a98d19 53489-368 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Sun Pharmaceutical Industries, Inc. FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 53489-369_8a8316fb-fb67-4618-bd56-977c38a98d19 53489-369 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Sun Pharmaceutical Industries, Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 53489-370_8a8316fb-fb67-4618-bd56-977c38a98d19 53489-370 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Sun Pharmaceutical Industries, Inc. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 53489-376_90cbbf48-e36f-46f5-8b58-c61b16b0aa86 53489-376 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20030828 ANDA ANDA076570 Sun Pharmaceutical Industries, Inc. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 53489-386_013dfdcc-0138-4f9d-a058-90b7ad1befb0 53489-386 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 19951214 ANDA ANDA072709 Sun Pharmaceutical Industries, Inc. MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 53489-387_013dfdcc-0138-4f9d-a058-90b7ad1befb0 53489-387 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 19951214 ANDA ANDA072709 Sun Pharmaceutical Industries, Inc. MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 53489-400_6712807e-e21e-4825-8cd0-ad68363dfc5f 53489-400 HUMAN PRESCRIPTION DRUG Nystatin nystatin TABLET, FILM COATED ORAL 19881222 ANDA ANDA062838 Sun Pharmaceutical Industries, Inc. NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20191231 53489-406_a78158e1-7c6b-4104-912e-f0650abe3fa9 53489-406 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 Mutual Pharmaceutical Company, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 53489-433_c7d3abf4-5ec3-412c-a7e9-d23a8fe4646a 53489-433 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20031023 20190131 ANDA ANDA040525 Sun Pharmaceutical Industries, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 53489-478_cf5ef067-e658-457f-ad94-ad9ed2b50ead 53489-478 HUMAN PRESCRIPTION DRUG SULINDAC sulindac TABLET ORAL 20090904 ANDA ANDA072050 Sun Pharmaceutical Industries, Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53489-479_cf5ef067-e658-457f-ad94-ad9ed2b50ead 53489-479 HUMAN PRESCRIPTION DRUG SULINDAC sulindac TABLET ORAL 20090904 ANDA ANDA072051 Sun Pharmaceutical Industries, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53489-500_2c96c6f9-3008-48ba-86ea-e9b83502da67 53489-500 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride Thioridazine Hydrochloride TABLET, FILM COATED ORAL 19881007 ANDA ANDA089953 Sun Pharmaceutical Industries, Inc. THIORIDAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53489-506_e030ea24-4db5-4eb4-9dc5-b4397c29cb60 53489-506 HUMAN PRESCRIPTION DRUG TOLMETIN SODIUM tolmetin sodium TABLET ORAL 20090904 ANDA ANDA073311 Mutual Pharmaceutical Company, Inc. TOLMETIN SODIUM 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 53489-507_e030ea24-4db5-4eb4-9dc5-b4397c29cb60 53489-507 HUMAN PRESCRIPTION DRUG TOLMETIN SODIUM tolmetin sodium CAPSULE ORAL 20090904 ANDA ANDA073311 Mutual Pharmaceutical Company, Inc. TOLMETIN SODIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 53489-510_eaee6613-379b-4a5e-8887-c6cce42e0917 53489-510 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 19930324 ANDA ANDA073137 Sun Pharmaceutical Industries, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 53489-511_eaee6613-379b-4a5e-8887-c6cce42e0917 53489-511 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 19930324 ANDA ANDA073137 Sun Pharmaceutical Industries, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 53489-517_eaee6613-379b-4a5e-8887-c6cce42e0917 53489-517 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 19930324 ANDA ANDA073137 Sun Pharmaceutical Industries, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 53489-529_0f924587-1e05-4755-80cd-7ce58ba0300f 53489-529 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19930330 ANDA ANDA073475 Mutual Pharmaceutical Company, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53489-530_0f924587-1e05-4755-80cd-7ce58ba0300f 53489-530 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19930330 ANDA ANDA073476 Mutual Pharmaceutical Company, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53489-531_86da35ec-fbfa-4474-bf4b-a58d9c737a19 53489-531 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19930429 ANDA ANDA073582 Mutual Pharmaceutical Company, Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 53489-532_86da35ec-fbfa-4474-bf4b-a58d9c737a19 53489-532 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19930429 ANDA ANDA073582 Mutual Pharmaceutical Company, Inc. ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 53489-536_0f924587-1e05-4755-80cd-7ce58ba0300f 53489-536 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19970730 ANDA ANDA074499 Mutual Pharmaceutical Company, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53489-551_0a371c0c-062e-4318-bc39-447108953a8b 53489-551 HUMAN PRESCRIPTION DRUG PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET, FILM COATED ORAL 20011129 ANDA ANDA075998 Sun Pharmaceutical Industries, Inc. PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] N 20181231 53489-552_0a371c0c-062e-4318-bc39-447108953a8b 53489-552 HUMAN PRESCRIPTION DRUG PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET, FILM COATED ORAL 20011129 ANDA ANDA075998 Sun Pharmaceutical Industries, Inc. PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] N 20181231 53489-553_0a371c0c-062e-4318-bc39-447108953a8b 53489-553 HUMAN PRESCRIPTION DRUG PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET, FILM COATED ORAL 20011129 ANDA ANDA075998 Sun Pharmaceutical Industries, Inc. PROPAFENONE HYDROCHLORIDE 300 mg/1 Antiarrhythmic [EPC] N 20181231 53489-590_f31e2835-b272-4f87-bbc7-6cb4ec25fde9 53489-590 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19950523 ANDA ANDA073541 Mutual Pharmaceutical CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 53489-591_f31e2835-b272-4f87-bbc7-6cb4ec25fde9 53489-591 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19950523 ANDA ANDA073541 Mutual Pharmaceutical CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 53489-607_36f83432-6257-4cda-9902-510ec4b0975c 53489-607 HUMAN PRESCRIPTION DRUG lovastatin lovastatin TABLET ORAL 20060414 ANDA ANDA077520 Mutual Pharmaceutical Company, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53489-608_36f83432-6257-4cda-9902-510ec4b0975c 53489-608 HUMAN PRESCRIPTION DRUG lovastatin lovastatin TABLET ORAL 20060414 ANDA ANDA077520 Mutual Pharmaceutical Company, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53489-609_36f83432-6257-4cda-9902-510ec4b0975c 53489-609 HUMAN PRESCRIPTION DRUG lovastatin lovastatin TABLET ORAL 20060414 ANDA ANDA077520 Mutual Pharmaceutical Company, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53489-647_1017ed84-4e22-480a-99c1-45c9f8b734b4 53489-647 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20050513 ANDA ANDA065134 Sun Pharmaceutical Industries, Inc. DOXYCYCLINE HYCLATE 20 mg/1 N 20181231 53489-648_6025ee68-2977-2fd4-e053-2a91aa0af234 53489-648 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20090909 ANDA ANDA078581 Sun Pharmaceutical Industries, Inc. TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 53489-649_6025ee68-2977-2fd4-e053-2a91aa0af234 53489-649 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20061026 ANDA ANDA071175 Sun Pharmaceutical Industries, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 53489-650_6025ee68-2977-2fd4-e053-2a91aa0af234 53489-650 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20061026 ANDA ANDA071175 Sun Pharmaceutical Industries, Inc. TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 53489-651_6025ee68-2977-2fd4-e053-2a91aa0af234 53489-651 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20061026 ANDA ANDA071175 Sun Pharmaceutical Industries, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 53489-676_a88d508e-8c7f-4e44-8ad2-a258d29e3cf5 53489-676 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20130812 ANDA ANDA040526 Sun Pharmaceutical Industries, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 53489-677_65f745e9-1116-4c2a-9de8-f64fbf92f641 53489-677 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid TABLET ORAL 20090831 NDA AUTHORIZED GENERIC NDA022418 Mutual Pharmaceutical Company, Inc. FENOFIBRIC ACID 35 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] E 20171231 53489-678_65f745e9-1116-4c2a-9de8-f64fbf92f641 53489-678 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid TABLET ORAL 20090831 NDA AUTHORIZED GENERIC NDA022418 Mutual Pharmaceutical Company, Inc. FENOFIBRIC ACID 105 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] E 20171231 53489-700_1a23e33b-b56f-4eee-9ca3-eee9ca86a24a 53489-700 HUMAN PRESCRIPTION DRUG Quinine Sulfate Quinine Sulfate CAPSULE ORAL 20120723 NDA AUTHORIZED GENERIC NDA021799 Sun Pharmaceutical Industries, Inc. QUININE SULFATE 324 mg/1 Antimalarial [EPC] N 20181231 53499-0098_c855b510-b56b-4c87-906d-e59ecbf09a7d 53499-0098 HUMAN OTC DRUG CHILDRENS ALPHA CF ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT,IPECAC, PHOSPHORUS TABLET SUBLINGUAL 20040701 20210321 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 7; 7; 7; 7; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-0133_99f11b30-ad57-4f8d-b070-51e1fd173d31 53499-0133 HUMAN OTC DRUG Coffea cruda Coffea cruda TABLET SUBLINGUAL 20060101 20190228 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc ARABICA COFFEE BEAN 6 [hp_X]/1 N 20181231 53499-0159_582a76b2-96ca-40a0-a6da-642f539fefdb 53499-0159 HUMAN OTC DRUG Umcka Cold Flu Berry Chewable Pelargonium sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus TABLET, CHEWABLE ORAL 20170821 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 1; 4; 4; 2; 6; 4; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-0165_6ba40f00-6239-4c5f-bfb7-190a25766a4a 53499-0165 HUMAN OTC DRUG Umcka ColdCare Childrens Cherry Pelargonium sidoides SYRUP ORAL 20090901 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc PELARGONIUM SIDOIDES ROOT 1 [hp_X]/120mL N 20181231 53499-0171_dc037233-4abb-4416-b961-cffc74756a5b 53499-0171 HUMAN OTC DRUG Coffea cruda Coffea cruda TABLET SUBLINGUAL 20060101 20190430 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ARABICA COFFEE BEAN 30 [hp_C]/1 N 20181231 53499-0172_481eeca1-06bd-466c-8c16-b234fc1cdd75 53499-0172 HUMAN OTC DRUG Coffea cruda Coffea cruda TABLET SUBLINGUAL 20060101 20180430 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ARABICA COFFEE BEAN 30 [hp_X]/1 N 20181231 53499-0190_70e70b4d-b45e-4ac4-a59d-cff1ec2b75e8 53499-0190 HUMAN OTC DRUG Alpha CF ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUSEUCALYPTUS GLOBULUS LEAF LIQUID SUBLINGUAL 20040701 20180331 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS; EUCALYPTUS GLOBULUS LEAF 4; 4; 2; 4; 3; 6; 2 [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 53499-0293_9f64c223-58a2-46d7-8ef5-295ec46baeb0 53499-0293 HUMAN OTC DRUG Cough and Bronchial ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN SYRUP ORAL 20040701 UNAPPROVED HOMEOPATHIC Schwabe North America ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN 3; 3; 6; 3; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_C]/118mL; [hp_X]/118mL; [hp_C]/118mL N 20181231 53499-0339_210cc887-bf3a-4deb-9b03-825225f23da1 53499-0339 HUMAN OTC DRUG ALPHA CF ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT,IPECAC , PHOSPHORUS TABLET SUBLINGUAL 20110818 20210331 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 4; 4; 2; 2; 4; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-0390_bbb71ddb-6576-465c-9800-f74fac479e49 53499-0390 HUMAN OTC DRUG Florasone CARDIOSPERMUM HALICACABUM FLOWERING TOP CREAM TOPICAL 20060101 UNAPPROVED HOMEOPATHIC Schwabe North America CARDIOSPERMUM HALICACABUM FLOWERING TOP 1 [hp_X]/28g N 20181231 53499-0393_1a594124-05d4-43e6-a5c1-c7d7d51dcf1d 53499-0393 HUMAN OTC DRUG Childrens Cough and Bronchial ANTIMONY PENTASULFIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, EUCALYPTUS GLOBULUS LEAF, IPECAC, STAR ANISE SYRUP ORAL 20040701 20190430 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc ANTIMONY PENTASULFIDE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA FLOWERING TOP; EUCALYPTUS GLOBULUS LEAF; IPECAC; STAR ANISE 6; 3; 3; 3; 4; 1 [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL N 20181231 53499-0533_4aa2b695-1a57-4d23-8183-d2241aa3da81 53499-0533 HUMAN OTC DRUG UMCKA THROAT PELARGONIUM SIDOIDES ROOT SPRAY ORAL 20140901 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc PELARGONIUM SIDOIDES ROOT 1 [hp_X]/59mL N 20181231 53499-0598_c6c3e824-96a0-4767-a03f-60af30e09be3 53499-0598 HUMAN OTC DRUG SMOKE FREE DIEFFENBACHIA SEGUINE, DAPHNE ODORA BARK, GRAPHITES, VALERIAN TABLET SUBLINGUAL 20110818 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc DIEFFENBACHIA SEGUINE; DAPHNE ODORA BARK; GRAPHITE; VALERIAN 6; 6; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-0693_29408b6b-c56f-4306-b87a-df7cf94e7998 53499-0693 HUMAN OTC DRUG Nightime Cough and Bronchial ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN SYRUP ORAL 20040701 UNAPPROVED HOMEOPATHIC Schwabe North America ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN; MEDICAGO SATIVA LEAF; OAT; ARABICA COFFEE BEAN 3; 3; 6; 3; 6; 1; 1; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_C]/118mL; [hp_X]/118mL; [hp_C]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL N 20181231 53499-0990_497abf22-ab9a-4438-83ec-643b38e9f404 53499-0990 HUMAN OTC DRUG PSORIAFLORA MAHONIA AQUIFOLIUM ROOT BARK CREAM TOPICAL 20060101 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc MAHONIA AQUIFOLIUM ROOT BARK 1 [hp_X]/28g N 20181231 53499-0991_6058ddce-416e-4322-8ede-a7eaf8a7e6be 53499-0991 HUMAN OTC DRUG TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF LIQUID ORAL 20060101 20190131 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc TOXICODENDRON PUBESCENS LEAF 3 [hp_X]/30mL N 20181231 53499-1060_ac845ef6-9d8d-42e0-8971-28adc1e11ec8 53499-1060 HUMAN OTC DRUG Umcka ColdCare Day Plus Night Umcka ColdCare Day Plus Night KIT 20151209 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. N 20181231 53499-1087_2882e1e6-b73e-469c-9a11-8dccf42ecb08 53499-1087 HUMAN OTC DRUG Umcka ColdCare Day Plus Night Umcka ColdCare Day Plus Night KIT 20160912 20180831 UNAPPROVED HOMEOPATHIC Schwabe North America N 20181231 53499-1193_eda94317-c762-499d-b6ce-4d0426cc469b 53499-1193 HUMAN OTC DRUG Cough and Bronchial with Zinc ANTIMONY PENTASULFIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, EUCALYPTUS GLOBULUS LEAF, IPECAC, SPONGIA OFFICINALIS SKELETON, ROASTED, ZINC GLUCONATE SYRUP ORAL 20040701 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc ANTIMONY PENTASULFIDE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA FLOWERING TOP; EUCALYPTUS GLOBULUS LEAF; IPECAC; SPONGIA OFFICINALIS SKELETON, ROASTED; ZINC GLUCONATE 8; 3; 3; 3; 4; 3; 1 [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL N 20181231 53499-1272_be366b74-0f74-4b4b-8223-fd5c97b5662d 53499-1272 HUMAN OTC DRUG Natrum muriaticum Natrum muriaticum TABLET SUBLINGUAL 20060101 20180731 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc SODIUM CHLORIDE 30 [hp_X]/1 N 20181231 53499-1390_e973e999-dc70-463f-8c9c-5d1835a5f7f5 53499-1390 HUMAN OTC DRUG ALPHA SH SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS TABLET SUBLINGUAL 20110818 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. SANGUINARIA CANADENSIS ROOT; GOLDENSEAL; SILICON DIOXIDE; POTASSIUM CHLORIDE; PULSATILLA VULGARIS 6; 6; 6; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-1833_44c9fb4d-6cc7-45a8-acfb-9bd9c41af294 53499-1833 HUMAN OTC DRUG Nux vomica Nux vomica TABLET SUBLINGUAL 20060101 20181231 UNAPPROVED HOMEOPATHIC Schwabe North America STRYCHNOS NUX-VOMICA SEED 6 [hp_X]/1 N 20181231 53499-1871_c8ef7c05-2adf-428e-b0d4-fae54320a605 53499-1871 HUMAN OTC DRUG Nux vomica Nux vomica TABLET SUBLINGUAL 20060101 20181031 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/1 N 20181231 53499-1872_6348be42-3c07-469b-9f0e-3f0568c8abac 53499-1872 HUMAN OTC DRUG Nux vomica Nux vomica TABLET SUBLINGUAL 20060101 20190831 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc STRYCHNOS NUX-VOMICA SEED 30 [hp_X]/1 N 20181231 53499-2137_9ebc1357-bfa1-453d-95e2-ea0543ae51e8 53499-2137 HUMAN OTC DRUG Umcka ColdCare Starter Kit Umcka ColdCare Starter Kit KIT 20171009 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. N 20181231 53499-2194_3de24bdd-f8e4-4a25-bb09-1416a4d68606 53499-2194 HUMAN OTC DRUG Umcka Allergy and Sinus PELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDE TABLET, CHEWABLE ORAL 20171211 UNAPPROVED HOMEOPATHIC Schwabe North American, Inc. PELARGONIUM SIDOIDES ROOT; HYDRASTIS CANADENSIS WHOLE; POTASSIUM CHLORIDE; SANGUINARIA CANADENSIS ROOT; PULSATILLA VULGARIS; SILICON DIOXIDE 1; 6; 3; 6; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-2390_8347946f-c5ed-42b5-a487-e7fc3ab04502 53499-2390 HUMAN OTC DRUG MIGRAIDE CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, GELSEMIUM SEMPERVIRENS ROOT, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOT TABLET SUBLINGUAL 20110818 20190531 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. CYCLAMEN PURPURASCENS TUBER; BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; SANGUINARIA CANADENSIS ROOT 3; 3; 3; 2; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-2391_5bec7187-eca9-41a9-bf3b-d9eb20e9376e 53499-2391 HUMAN OTC DRUG Migraide CYCLAMEN PURPURASCENS TUBER, BLACK COHOSH, IRIS VERSICOLOR WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, SANGUINARIA CANADENSIS ROOT TABLET SUBLINGUAL 20150702 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. CYCLAMEN PURPURASCENS TUBER; BLACK COHOSH; IRIS VERSICOLOR WHOLE; GELSEMIUM SEMPERVIRENS WHOLE; SANGUINARIA CANADENSIS ROOT 3; 3; 2; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-2590_0adb8861-425a-41a5-b0f5-10903d372e01 53499-2590 HUMAN OTC DRUG Allergiemittel CARDIOSPERMUM HALICACABUM FLOWERING TOP, GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT TABLET SUBLINGUAL 20110818 20211231 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc CARDIOSPERMUM HALICACABUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-2798_8ea41994-4724-4a92-b916-d53432cb6118 53499-2798 HUMAN OTC DRUG SCIATIC AIDE ARSENIC TRIOXIDE, CHAMOMILE, CITRULLUS COLOCYNTHIS FRUIT PULP, SULFUR TABLET SUBLINGUAL 20110818 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc ARSENIC TRIOXIDE; CHAMOMILE; CITRULLUS COLOCYNTHIS FRUIT PULP; SULFUR 12; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-3533_f9faa58a-49f8-49a1-b5df-890c1b58c394 53499-3533 HUMAN OTC DRUG Arnica Montana Arnica Montana TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Schwabe North America ARNICA MONTANA 6 [hp_X]/1 N 20181231 53499-3571_2d843caa-f5ac-4df5-8b6b-9bbcf43055e4 53499-3571 HUMAN OTC DRUG Arnica Montana Arnica Montana TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ARNICA MONTANA 30 [hp_C]/1 N 20191231 53499-3572_1394e8c3-810c-42ff-9cf6-8848e4c8921c 53499-3572 HUMAN OTC DRUG Arnica Montana Arnica Montana TABLET SUBLINGUAL 20060101 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ARNICA MONTANA 30 [hp_X]/1 N 20181231 53499-4098_2a2a6bb0-9494-4e2c-ab05-833309111207 53499-4098 HUMAN OTC DRUG Bronchitis and Asthma Aide ACONITUM NAPELLUS, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN TABLET SUBLINGUAL 20110818 20210228 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc ACONITUM NAPELLUS; CALCIUM SULFIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN 3; 12; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-4633_6763e75f-cfe3-4a81-96f0-af17edd17c7c 53499-4633 HUMAN OTC DRUG Rhus toxicodendron Rhus toxicodendron TABLET SUBLINGUAL 20060101 20181031 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc TOXICODENDRON PUBESCENS LEAF 6 [hp_X]/1 N 20181231 53499-4671_fce51964-2419-4b92-9f33-d91df2d26dc1 53499-4671 HUMAN OTC DRUG Rhus toxicodendron Rhus toxicodendron TABLET SUBLINGUAL 20060101 20180930 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc TOXICODENDRON PUBESCENS LEAF 30 [hp_C]/1 N 20181231 53499-4672_bd76cbc1-cb83-45dc-881b-bc20464d13ea 53499-4672 HUMAN OTC DRUG Rhus toxicodendron Rhus toxicodendron TABLET SUBLINGUAL 20060101 20190228 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. TOXICODENDRON PUBESCENS LEAF 30 [hp_X]/1 N 20181231 53499-5090_4258b041-7675-4084-92db-7c916eeae5a4 53499-5090 HUMAN OTC DRUG Arniflora ARNICA MONTANA GEL TOPICAL 20110101 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc ARNICA MONTANA 1 [hp_X]/28g N 20181231 53499-5144_aee33ec8-3e24-4a70-b0c9-313675b260fe 53499-5144 HUMAN OTC DRUG Umcka Coldcare Cherry Pelargonium sidoides TABLET, CHEWABLE ORAL 20110824 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc PELARGONIUM SIDOIDES ROOT 1 [hp_X]/1 N 20181231 53499-5145_db467dc3-5543-4acf-ab69-46e520cfe055 53499-5145 HUMAN OTC DRUG Umcka ColdCare Mint Chewable Pelargonium sidoides TABLET, CHEWABLE ORAL 20111011 20180430 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/1 N 20181231 53499-5146_954b14ba-b82e-4acc-a815-cc668f8bb135 53499-5146 HUMAN OTC DRUG Umcka Coldcare Lemon Pelargonium sidoides POWDER ORAL 20090701 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/5g N 20181231 53499-5148_36ea93a4-bee1-468a-8e19-80af4d859a0d 53499-5148 HUMAN OTC DRUG Umcka Cold Flu Berry ACONITUM NAPELLUS, BRYONIA ALBA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PELARGONIUM SIDOIDES, PHOSPHORUS SYRUP ORAL 20060101 20190228 UNAPPROVED HOMEOPATHIC Schwabe North America ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS 4; 4; 2; 2; 4; 3; 1; 6 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL N 20181231 53499-5149_7c188c48-159e-47a3-983e-132d25fcb61f 53499-5149 HUMAN OTC DRUG Umcka Cold Flu Sugar Free Orange Aconitum napellus, Bryonia alba, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Ipecacuanha, Pelargonium sidoides, Phosphorus SYRUP ORAL 20060101 20190131 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS 4; 4; 2; 2; 4; 3; 1; 6 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL N 20181231 53499-5159_e2cb283a-3a15-451a-b832-3bff536809fe 53499-5159 HUMAN OTC DRUG Umcka Cold Flu Berry Pelargonium sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus TABLET, CHEWABLE ORAL 20110826 20180831 UNAPPROVED HOMEOPATHIC Schwabe North America PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 1; 4; 4; 2; 2; 4; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-5161_8a86506a-aeed-48e3-9c75-509001b5ef91 53499-5161 HUMAN OTC DRUG Umcka Cold Flu Orange Pelargonium sidoides, Aconitum Napellus, Bry1onia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus TABLET, CHEWABLE ORAL 20110824 20181031 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 1; 4; 4; 2; 2; 4; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-5190_8478ef29-d726-4e50-b95e-022f90d9a53c 53499-5190 HUMAN OTC DRUG Califlora Calendula officinalis GEL TOPICAL 20060101 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/78g N 20181231 53499-5270_ef36ca74-5962-47a9-b8e7-fe050d840c1c 53499-5270 HUMAN OTC DRUG Umcka Original ColdCare Pelargonium sidoides LIQUID ORAL 20090202 UNAPPROVED HOMEOPATHIC Schwabe North America PELARGONIUM SIDOIDES ROOT 1 [hp_X]/30mL N 20181231 53499-5271_3dfbc74c-194a-438d-b2d3-8f78b1df9ff5 53499-5271 HUMAN OTC DRUG Umcka ColdCare Alcohol-Free Pelargonium sidoides LIQUID ORAL 20090202 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/30mL N 20181231 53499-5272_7f6376f6-ac42-4191-9c7c-e5a5a393c179 53499-5272 HUMAN OTC DRUG Umcka Menthol Pelargonium sidoides SYRUP ORAL 20060101 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc PELARGONIUM SIDOIDES ROOT 1 [hp_X]/120mL N 20181231 53499-5273_6d9ccac2-ca9c-47c6-9fb4-3ceb02053475 53499-5273 HUMAN OTC DRUG Umcka ColdCare Alcohol Free Cherry Pelargonium sidoides SYRUP ORAL 20060101 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc PELARGONIUM SIDOIDES ROOT 1 [hp_X]/240mL N 20181231 53499-5290_1237ec8c-f505-43f7-a84c-0ce9c24b2505 53499-5290 HUMAN OTC DRUG Triflora Symphytum Officinale, Rhus Toxicodendron, Ledum Palustre GEL TOPICAL 20060101 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc COMFREY ROOT; TOXICODENDRON PUBESCENS LEAF; LEDUM PALUSTRE TWIG 1; 3; 1 [hp_X]/78g; [hp_X]/78g; [hp_X]/78g N 20181231 53499-5347_6f9ba490-d631-4fe5-847b-d657daf1af80 53499-5347 HUMAN OTC DRUG Umcka FastActives Cherry Pelargonium sidoides POWDER ORAL 20060101 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. PELARGONIUM SIDOIDES ROOT 1 [hp_X]/700mg N 20181231 53499-5349_663703e4-6457-4008-b888-e3b6d95aab7e 53499-5349 HUMAN OTC DRUG Umcka FastActives Berry Pelargonium sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus POWDER ORAL 20060101 20190331 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 1; 4; 4; 2; 4; 3; 6 [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg N 20181231 53499-5390_80f64e1d-22df-4d0a-b100-5d0c2b84e590 53499-5390 HUMAN OTC DRUG Ssssting Stop Echinacea Angustifolia, Ledum Palustre Twig, Urtica Dioica, GEL TOPICAL 20040701 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ECHINACEA ANGUSTIFOLIA; LEDUM PALUSTRE TWIG; URTICA DIOICA 1; 1; 1 [hp_X]/78g; [hp_X]/78g; [hp_X]/78g N 20181231 53499-5492_ffea5d8d-9e91-46b2-a7d4-dc6fd5924664 53499-5492 HUMAN OTC DRUG Sports For Trauma Bellis Perennis, Hypericum Perfomatum,Toxicodendron Pubscens Leaf, Ruta Graveolens Flowering Top GEL TOPICAL 20040701 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc BELLIS PERENNIS; HYPERICUM PERFORATUM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP 1; 2; 3; 1 [hp_X]/71g; [hp_X]/71g; [hp_X]/71g; [hp_X]/71g N 20181231 53499-5533_08cb67d7-7e4c-41e4-92f6-18f93c117bf1 53499-5533 HUMAN OTC DRUG Belladonna Belladonna TABLET SUBLINGUAL 20060101 20190430 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc ATROPA BELLADONNA 6 [hp_X]/1 N 20181231 53499-5571_da191312-a767-4369-a166-da38d8003dc5 53499-5571 HUMAN OTC DRUG Belladonna 30C Belladonna TABLET SUBLINGUAL 20060101 20180831 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ATROPA BELLADONNA 30 [hp_C]/1 N 20181231 53499-5794_c3035832-e53c-41f5-9e7a-1f0442687d90 53499-5794 HUMAN OTC DRUG Umcka ColdCare Sugar Free Grape Pelargonium sidoides SYRUP ORAL 20060901 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc PELARGONIUM SIDOIDES ROOT 1 [hp_X]/120mL N 20181231 53499-5799_03b8464e-566d-41c9-93e9-41259b5b8bef 53499-5799 HUMAN OTC DRUG SAMBUCUS FLUCARE ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOP LOZENGE ORAL 20111001 20181031 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP; EUPATORIUM PERFOLIATUM FLOWERING TOP 4; 4; 2; 4; 3; 6; 3; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-5803_c6232204-7cc2-4fe3-b476-bed853bb330f 53499-5803 HUMAN OTC DRUG SAMBUCUS FLUCARE ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOP SYRUP ORAL 20111025 20190331 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP 4; 4; 2; 2; 4; 3; 6; 3 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 53499-5845_fc788091-cadc-4840-9af0-e5fff53cba14 53499-5845 HUMAN OTC DRUG Umcka Elderberry Umcka Elderberry SYRUP ORAL 20121001 20190331 UNAPPROVED HOMEOPATHIC Schwabe North America ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PELARGONIUM SIDOIDES ROOT; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP 4; 4; 2; 2; 4; 3; 1; 6; 3 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL N 20181231 53499-5864_5b7c6857-e91a-4c9a-befc-a9d70e097df6 53499-5864 HUMAN OTC DRUG Umcka Cough ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED , TIN, PELARGONIUM SIDOIDES ROOT UMCKA COUGH SYRUP ORAL 20121001 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CALCIUM SULFIDE; TIN; SPONGIA OFFICINALIS SKELETON, ROASTED 1; 3; 3; 6; 6; 3 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_C]/120mL; [hp_C]/120mL; [hp_X]/120mL N 20181231 53499-5933_2bdf51dc-7dee-438a-b40c-3f085b5178b8 53499-5933 HUMAN OTC DRUG Sepia Sepia TABLET SUBLINGUAL 20060101 20190930 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc SEPIA OFFICINALIS JUICE 6 [hp_X]/1 N 20181231 53499-5971_cfdfe999-e944-4c81-b3d2-75dacc7e8e27 53499-5971 HUMAN OTC DRUG Sepia Sepia TABLET SUBLINGUAL 20060101 20191031 UNAPPROVED HOMEOPATHIC Schwabe North America SEPIA OFFICINALIS JUICE 30 [hp_C]/1 N 20181231 53499-5972_ec4c0f49-2a99-45e9-91f2-67a0f41cf884 53499-5972 HUMAN OTC DRUG Sepia Sepia TABLET SUBLINGUAL 20060101 20180430 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc SEPIA OFFICINALIS JUICE 30 [hp_X]/1 N 20181231 53499-6372_eae941e0-e1e7-4fdd-8158-6a828f0416f5 53499-6372 HUMAN OTC DRUG Ignatia amara Ignatia amara TABLET SUBLINGUAL 20060101 20190228 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. STRYCHNOS IGNATII SEED 30 [hp_X]/1 N 20181231 53499-7133_e64db273-9cbf-46af-b57d-d3e9b4dce944 53499-7133 HUMAN OTC DRUG Sulphur SULFUR TABLET SUBLINGUAL 20060101 20190131 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc SULFUR 6 [hp_X]/1 N 20181231 53499-7172_db048645-c08c-4ba0-8d80-a2c8f58a575f 53499-7172 HUMAN OTC DRUG Sulphur SULFUR TABLET SUBLINGUAL 20060101 20190228 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc SULFUR 30 [hp_X]/1 N 20181231 53499-7271_114635da-4806-4434-896c-ec4acb09aa1f 53499-7271 HUMAN OTC DRUG Kali bichromicum Kali bichromicum TABLET SUBLINGUAL 20060101 20190228 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. POTASSIUM DICHROMATE 30 [hp_C]/1 N 20181231 53499-8333_a3b99625-cfcc-4e55-a65f-9ff81bfeabe4 53499-8333 HUMAN OTC DRUG Thuja occidentalis Thuja occidentalis TABLET SUBLINGUAL 20060101 20181031 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. CEDAR LEAF OIL 6 [hp_X]/1 N 20181231 53499-8371_9f65a3da-ed27-425d-a9e9-3b78ba4f5d63 53499-8371 HUMAN OTC DRUG Thuja occidentalis Thuja occidentalis TABLET SUBLINGUAL 20060101 20190331 UNAPPROVED HOMEOPATHIC Schwabe North America CEDAR LEAF OIL 30 [hp_C]/1 N 20181231 53499-8372_f0133f0a-2abb-4d4f-a356-120363efbab5 53499-8372 HUMAN OTC DRUG Thuja occidentalis Thuja occidentalis TABLET SUBLINGUAL 20060101 20181130 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc CEDAR LEAF OIL 30 [hp_X]/1 N 20181231 53499-9098_f7133efc-3b22-4d5d-99eb-2051d9ce1fb2 53499-9098 HUMAN OTC DRUG CHILDRENS ALPHA CF ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS TABLET SUBLINGUAL 20170701 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 7; 7; 7; 7; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-9145_4eff39e2-831c-4398-978c-e5041b7ca256 53499-9145 HUMAN OTC DRUG Umcka ColdCare Mint Chewable Pelargonium sidoides TABLET, CHEWABLE ORAL 20161229 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc PELARGONIUM SIDOIDES ROOT 1 [hp_X]/1 N 20181231 53499-9148_fab081a7-03cb-4a79-9518-23bb27eb818a 53499-9148 HUMAN OTC DRUG Umcka Cold Flu Berry ACONITUM NAPELLUS, BRYONIA ALBA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PELARGONIUM SIDOIDES, PHOSPHORUS SYRUP ORAL 20170101 UNAPPROVED HOMEOPATHIC Schwabe North America PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; IPECAC 1; 4; 2; 4; 6; 4; 6; 3 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL N 20181231 53499-9149_58ff45aa-62ce-4e74-8160-42c9377cbba4 53499-9149 HUMAN OTC DRUG Umcka Cold Flu Sugar Free Orange Pelargonium sidoides, Aconitum napellus, Bryonia alba, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Ipecacuanha, Phosphorus SYRUP ORAL 20171014 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; IPECAC 1; 4; 2; 4; 6; 4; 6; 3 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL N 20181231 53499-9159_aaa60da3-0a8f-4499-b171-99d9ad73d87f 53499-9159 HUMAN OTC DRUG Umcka Cold Flu Berry Chewable Pelargonium sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus TABLET, CHEWABLE ORAL 20161201 20190131 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 1; 4; 4; 2; 2; 4; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-9161_e1b5d1da-9988-40cb-8cdb-b1d2327e4263 53499-9161 HUMAN OTC DRUG Umcka Cold Flu Orange Pelargonium sidoides, Aconitum napellus, Bryonia, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Ipecacuanha, Phosphorus TABLET, CHEWABLE ORAL 20170908 UNAPPROVED HOMEOPATHIC Schwabe North Amertica, Inc. PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 1; 4; 4; 2; 6; 4; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-9339_0a834d57-4b3f-4481-a911-54719a3c77e0 53499-9339 HUMAN OTC DRUG ALPHA CF ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT TABLET SUBLINGUAL 20170401 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; EUCALYPTUS GLOBULUS LEAF; PHOSPHORUS 4; 4; 6; 4; 3; 2; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-9349_79973b89-ed4a-478f-a322-35dbdf813574 53499-9349 HUMAN OTC DRUG Umcka FastActives Berry Pelargonium sidoides, Aconitum Napellus, Bryonia, Eucalyptus Globulus, Eupatorium Perfoliatum, Gelsemium Sempervirens, Ipecacuanha, Phosphorus POWDER ORAL 20170414 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; IPECAC 1; 4; 2; 4; 6; 4; 6; 3 [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg; [hp_X]/912mg N 20191231 53499-9393_dde5335c-1881-469f-9cd7-2611f4e67afd 53499-9393 HUMAN OTC DRUG Childrens Cough and Bronchial ANTIMONY PENTASULFIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, EUCALYPTUS GLOBULUS LEAF, IPECAC, ILLICIUM ANISATUM WHOLE SYRUP ORAL 20170418 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc ANTIMONY PENTASULFIDE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA FLOWERING TOP; EUCALYPTUS GLOBULUS LEAF; IPECAC; ILLICIUM ANISATUM WHOLE 6; 3; 3; 3; 4; 3 [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL N 20181231 53499-9498_9ffd86c7-2d64-496d-87eb-a4bc2104ed68 53499-9498 HUMAN OTC DRUG Bronchial and Breathing Aide ACONITUM NAPELLUS, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN TABLET SUBLINGUAL 20170401 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc ACONITUM NAPELLUS; CALCIUM SULFIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN 3; 12; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-9590_50a2cf9f-5d0c-4d27-8298-a3b92af8c1bb 53499-9590 HUMAN OTC DRUG Allergiemittel CARDIOSPERMUM HALICACABUM FLOWERING TOP, GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT TABLET SUBLINGUAL 20170401 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. CARDIOSPERMUM HALICACABUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-9598_cfc501fa-656e-48e4-9f9f-98db2746eb00 53499-9598 HUMAN OTC DRUG SMOKE FREE DIEFFENBACHIA SEGUINE, DAPHNE ODORA BARK, GRAPHITES, VALERIAN TABLET SUBLINGUAL 20170601 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. DIEFFENBACHIA SEGUINE; DAPHNE ODORA BARK; GRAPHITE; VALERIAN 6; 12; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-9779_d4f5434c-ff94-4249-81e8-a32e8b63be0c 53499-9779 HUMAN OTC DRUG SAMBUCUS FLUCARE ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOP LOZENGE ORAL 20170908 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; SAMBUCUS NIGRA FLOWERING TOP; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; IPECAC 4; 2; 3; 4; 6; 4; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 53499-9803_2a67244d-6c5e-43e5-8045-b4b8be596ead 53499-9803 HUMAN OTC DRUG SAMBUCUS FLUCARE ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUCALYPTUS GLOBULUS LEAF, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PHOSPHORUS, SAMBUCUS NIGRA FLOWERING TOP SYRUP ORAL 20171003 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc. ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; SAMBUCUS NIGRA FLOWERING TOP; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORUS; IPECAC 4; 2; 3; 4; 6; 4; 6; 3 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL N 20181231 53499-9845_b7fbbefc-0d31-4036-8cfd-6824e2d12c67 53499-9845 HUMAN OTC DRUG Umcka Elderberry Umcka Elderberry SYRUP ORAL 20170515 UNAPPROVED HOMEOPATHIC Schwabe North America PELARGONIUM SIDOIDES ROOT; ACONITUM NAPELLUS; EUCALYPTUS GLOBULUS LEAF; SAMBUCUS NIGRA FLOWERING TOP; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PHOSPHORUS 4; 4; 2; 3; 4; 6; 4; 3; 6 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL N 20181231 53499-9991_a6ff2429-a9f9-4f50-a11e-540b99510901 53499-9991 HUMAN OTC DRUG TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF LIQUID ORAL 20170415 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc TOXICODENDRON PUBESCENS LEAF 3 [hp_X]/30mL N 20181231 53507-001_755d593f-f508-47f8-b91f-145880662d08 53507-001 HUMAN OTC DRUG DEODORANT Triclocarban SOAP TOPICAL 20121024 OTC MONOGRAPH NOT FINAL part333A Shanghai Kangyi Tourism Products Co., Ltd. TRICLOCARBAN .29 g/100g E 20171231 53510-000_4df32bbd-7ce9-4391-855a-96d79d7e9919 53510-000 HUMAN OTC DRUG DELUXE Dish DETERGENT TRICLOSAN SOAP TOPICAL 20140930 OTC MONOGRAPH NOT FINAL part333E Showline, Inc. TRICLOSAN 1 mg/mL E 20171231 53519-618_97097f6c-48c0-40d1-80ab-21c0cc0d011b 53519-618 HUMAN OTC DRUG Joints and Muscles Pain Relieving Camphor (Natural) PATCH TOPICAL 20130106 OTC MONOGRAPH NOT FINAL part348 Chongqing Yilin Science and Technology Co., Ltd. CAMPHOR (NATURAL) 22.5 mg/1 E 20171231 53550-001_2f02c0ed-659f-425f-bc7e-fa78038a5129 53550-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19790101 UNAPPROVED MEDICAL GAS M & A Welding Supply Co., Inc OXYGEN 995 mL/L E 20171231 53554-010_a5015805-94e8-4787-be9e-6d1346da45f3 53554-010 HUMAN OTC DRUG AMRUTANJAN RELIEF PAIN BALM CAMPHOR , MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20150423 OTC MONOGRAPH NOT FINAL part348 AMRUTANJAN HEALTH CARE LIMITED CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE .1; .08; .14 g/g; g/g; g/g N 20181231 53554-020_a5a8f9b4-0c58-49ea-9625-eba310f61aae 53554-020 HUMAN OTC DRUG AMRUTANJAN RELIEF STRONG PAIN BALM MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20150423 OTC MONOGRAPH NOT FINAL part348 AMRUTANJAN HEALTH CARE LIMITED MENTHOL; METHYL SALICYLATE .15; .15 g/g; g/g N 20181231 53554-030_d5d540ab-f44d-4f36-84a7-9565f5b91c41 53554-030 HUMAN OTC DRUG AMRUTANJAN RELIEF COLD RUB camphor (synthetic), eucalyptus oil, and menthol OINTMENT TOPICAL 20150416 OTC MONOGRAPH FINAL part341 AMRUTANJAN HEALTH CARE LIMITED CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL .048; .012; .026 g/g; g/g; g/g N 20181231 53567-0101_e123425c-cbac-47c2-b511-b07c4b14dee5 53567-0101 HUMAN OTC DRUG SuperSmile Professional Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110628 OTC MONOGRAPH FINAL part355 ROBELL RESEARCH, INC. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 53567-0552_128751b6-69a0-046a-e054-00144ff88e88 53567-0552 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20140101 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g E 20171231 53567-0717_16705b72-55a9-4f0e-8e78-9279ef156970 53567-0717 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20060101 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g E 20171231 53567-0722_845e5e0a-1ada-45f2-a1f0-dd7c7ba99cb0 53567-0722 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20060101 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g E 20171231 53567-0723_1285da82-49b0-23e0-e054-00144ff8d46c 53567-0723 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20060101 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g E 20171231 53567-0738_5f4c4bd1-ec8d-ba99-e053-2a91aa0aea54 53567-0738 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20161104 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 53567-0747_5f4c1679-2879-26b8-e053-2a91aa0a83cb 53567-0747 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20170501 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 53567-0748_5f4bd0ff-4ea3-3756-e053-2991aa0af689 53567-0748 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20170501 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 53567-0926_12859035-9f55-1948-e054-00144ff8d46c 53567-0926 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20140101 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g E 20171231 53567-0933_5fdab419-88a5-58bc-e053-2a91aa0a4b01 53567-0933 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20140101 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 53567-0971_1285da93-6ca2-2841-e054-00144ff8d46c 53567-0971 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20140101 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 53567-0971_5fd8694c-e200-48b2-e053-2991aa0a0ccc 53567-0971 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20140101 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 53567-0972_1287ecc8-282e-0f59-e054-00144ff88e88 53567-0972 HUMAN OTC DRUG Supersmile Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL; ORAL 20140714 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g N 20181231 53567-6044_1d9c0c38-cbc7-4aef-b188-ecc3898bb42d 53567-6044 HUMAN OTC DRUG SuperSmile Professional Whitening Toothpaste PASTE, DENTIFRICE DENTAL 20110628 OTC MONOGRAPH FINAL part355 Robell Research, Inc. SODIUM MONOFLUOROPHOSPHATE .83 g/100g N 20181231 53590-100_198ef84d-7087-4fd7-bceb-d39f423f48f5 53590-100 HUMAN OTC DRUG MOZI-Q Ledum Palustre Twig, Urtica Urens, Simaba Cedron Seed, Delphinium Staphisagria Seed, Grindelia Hirsutula Flowering Top TABLET, CHEWABLE ORAL 20121015 UNAPPROVED HOMEOPATHIC Xerion Dispensary Ltd. LEDUM PALUSTRE TWIG; URTICA URENS; SIMABA CEDRON SEED; DELPHINIUM STAPHISAGRIA SEED; GRINDELIA HIRSUTULA FLOWERING TOP 3; 6; 4; 4; 6 [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1 E 20171231 53590-102_528f3958-38f7-4179-89e1-4a5220937375 53590-102 HUMAN OTC DRUG MOZI-Qfor kids and infa for kids and infants Ledum Palustre Twig, Urtica Urens, Simaba Cedron Seed, Delphinium Staphisagria Seed, Grindelia Hirsutula Flowering Top LIQUID ORAL 20140201 UNAPPROVED HOMEOPATHIC Xerion Dispensary Ltd. LEDUM PALUSTRE TWIG; URTICA URENS; GRINDELIA HIRSUTULA FLOWERING TOP; SIMABA CEDRON SEED; DELPHINIUM STAPHISAGRIA SEED 3; 6; 6; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL E 20171231 53590-104_556eb037-1b56-41d0-88dd-052ce3bd5580 53590-104 HUMAN OTC DRUG MOZI-Q Ledum Palustre Twig, Urtica Urens, Simaba Cedron Seed, Delphinium Staphisagria Seed, Grindelia Hirsutula Flowering Top LOTION TOPICAL 20140201 UNAPPROVED HOMEOPATHIC Xerion Dispensary Ltd. LEDUM PALUSTRE TWIG; URTICA URENS; GRINDELIA HIRSUTULA FLOWERING TOP; SIMABA CEDRON SEED; DELPHINIUM STAPHISAGRIA SEED 3; 6; 6; 4; 4 [hp_X]/50g; [hp_X]/50g; [hp_C]/50g; [hp_C]/50g; [hp_X]/50g E 20171231 53598-003_c86191d5-b44f-4440-bd05-3aad8d90413b 53598-003 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20130402 OTC MONOGRAPH NOT FINAL part343 Bonita Pharmaceuticals LLC ACETAMINOPHEN 500 mg/1 E 20171231 53598-004_d602b60d-906b-4e13-ba20-185406d5739a 53598-004 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride TABLET, COATED ORAL 20130521 OTC MONOGRAPH FINAL part341 Bonita Pharmaceuticals LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 53598-007_95fb86dd-1cd2-4fbe-9395-493cb8d932ec 53598-007 HUMAN OTC DRUG Instant Hand Sanitizer Gel Ethyl Alcohol GEL TOPICAL 20130912 OTC MONOGRAPH NOT FINAL part333E Bonita Pharmaceuticals LLC ALCOHOL 18.6 mL/30mL E 20171231 53603-1001_76305dfe-721d-4d9b-ad9b-0569bec13c33 53603-1001 HUMAN OTC DRUG Instant Hand Sanitizer Blue Raspberry ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1002_28c3f21d-0e80-4600-ac64-52b875d14261 53603-1002 HUMAN OTC DRUG Instant Hand Sanitizer Candy Apple ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1003_14cdfbab-b4ac-4eec-862a-d963764ac6a6 53603-1003 HUMAN OTC DRUG Instant Hand Sanitizer Fresh Aloe ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1004_aae8b9e2-50f5-4acc-8c85-ccbb00299545 53603-1004 HUMAN OTC DRUG Instant Hand Sanitizer Lemon Drop ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1005_4b7d407d-6bcd-46a9-b799-c0b99d38d755 53603-1005 HUMAN OTC DRUG Instant Hand Sanitizer Sugar Plum ETHYL ALCOHOL GEL TOPICAL 20130516 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1006_ce1419ab-8d7c-4e84-b9c9-fb302a191f60 53603-1006 HUMAN OTC DRUG Instant Hand Sanitizer Twisted Peppermint ETHYL ALCOHOL GEL TOPICAL 20130516 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1007_16931f00-20bd-4f99-b05e-882b0353d546 53603-1007 HUMAN OTC DRUG Instant Hand Sanitizer Chinese Cherry Blossom ETHYL ALCOHOL GEL TOPICAL 20130516 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1008_9f6f1894-2716-418c-944c-e7201d3d5861 53603-1008 HUMAN OTC DRUG Instant Hand Sanitizer Vanilla Noel ETHYL ALCOHOL GEL TOPICAL 20130516 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1009_c91f4d44-0e19-4551-8460-94fc6d617d08 53603-1009 HUMAN OTC DRUG Simply Clean Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141125 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1010_3f819abb-2fe8-49b5-8ba8-f6920b4aebe6 53603-1010 HUMAN OTC DRUG Simply Clean Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1011_c34125de-3f6a-4100-ade9-1f77c0284278 53603-1011 HUMAN OTC DRUG Simply Clean Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1012_e217e181-f3ac-4ede-a0bc-d30c372bb971 53603-1012 HUMAN OTC DRUG Simply Clean Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1013_1a074c20-4fcf-4882-944b-aa7ec9b89065 53603-1013 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1014_148374df-408d-48bf-9167-965cdcac1b29 53603-1014 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1015_f571a83c-754d-47df-a7eb-5254565b9712 53603-1015 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1016_d8652ea3-3094-4fd5-a41c-4675ddb534f8 53603-1016 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1017_03359f55-e297-4896-a6c4-527c73381b87 53603-1017 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1018_130c2c15-7fc5-4eff-e054-00144ff8d46c 53603-1018 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150406 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1019_143c7f3e-a4c3-097d-e054-00144ff8d46c 53603-1019 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150406 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1020_143c7f3e-a4d2-097d-e054-00144ff8d46c 53603-1020 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150406 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1021_2444f4e5-9829-7478-e054-00144ff88e88 53603-1021 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150406 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1022_143daef7-bf2a-4569-e054-00144ff8d46c 53603-1022 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150406 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1023_1802d381-8585-3390-e054-00144ff88e88 53603-1023 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1024_180c55e7-9fdb-4890-e054-00144ff88e88 53603-1024 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1025_180c55e7-9fec-4890-e054-00144ff88e88 53603-1025 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1026_29acd01b-c887-06b9-e054-00144ff8d46c 53603-1026 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150721 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1027_29acd01b-c884-06b9-e054-00144ff8d46c 53603-1027 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150721 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1028_29acd01b-c880-06b9-e054-00144ff8d46c 53603-1028 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150721 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1029_1fc52f3b-3a70-3fa5-e054-00144ff8d46c 53603-1029 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150721 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1030_1fc668e8-f2a9-38af-e054-00144ff88e88 53603-1030 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150721 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1031_29acaf12-9664-6d08-e054-00144ff8d46c 53603-1031 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150721 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1032_1fc52f3b-3a74-3fa5-e054-00144ff8d46c 53603-1032 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150721 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1033_29ac9d22-3471-55bf-e054-00144ff88e88 53603-1033 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150721 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1034_244504d0-cc03-0cbc-e054-00144ff8d46c 53603-1034 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150926 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1035_20a33f8a-ac37-106e-e054-00144ff88e88 53603-1035 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150926 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1036_20b17efc-1bc2-681f-e054-00144ff88e88 53603-1036 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150926 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1037_20b1869b-be81-5ecb-e054-00144ff8d46c 53603-1037 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150927 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1038_20b17efc-1bc7-681f-e054-00144ff88e88 53603-1038 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150927 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1039_20b17efc-1bcd-681f-e054-00144ff88e88 53603-1039 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150927 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1040_2ec68597-4175-4b57-e054-00144ff8d46c 53603-1040 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20160324 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1041_4075f8dd-6124-061c-e054-00144ff8d46c 53603-1041 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20161105 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1042_40ad95ba-7518-4233-e054-00144ff8d46c 53603-1042 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20161107 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1043_40ad8cdb-13b4-2df3-e054-00144ff88e88 53603-1043 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20161107 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1044_40ad8cdb-13c3-2df3-e054-00144ff88e88 53603-1044 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20161107 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1045_40ae4081-a748-48e2-e054-00144ff88e88 53603-1045 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20161107 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1046_40ae366b-48a2-52e4-e054-00144ff8d46c 53603-1046 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20161107 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1047_46367843-c371-0288-e054-00144ff88e88 53603-1047 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20170116 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1048_4636e39d-3257-1529-e054-00144ff88e88 53603-1048 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20170116 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-1049_464b7a83-0be4-6d33-e054-00144ff88e88 53603-1049 HUMAN OTC DRUG instant hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20170116 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-2001_fd2cdb32-524b-4589-bbee-1d043bd4b291 53603-2001 HUMAN OTC DRUG Instant Hand Sanitizer Blue Raspberry ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-2002_16b25737-a8c0-4270-bdfd-f8cc7ecd7b38 53603-2002 HUMAN OTC DRUG Instant Hand Sanitizer Bubble Gum ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-2003_e2be66b2-ba2f-4861-97b4-45dab38c4743 53603-2003 HUMAN OTC DRUG Instant Hand Sanitizer Lemon Drop ETHYL ALCOHOL GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-2004_66a5c113-5ad5-4df6-a7e0-26bef39d6e68 53603-2004 HUMAN OTC DRUG Instant Hand Sanitizer Strawberry Kiss ETHYL ALCOHOL GEL TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mg/100mL N 20181231 53603-2005_f6f645b6-4598-4560-a986-3a1d2159d342 53603-2005 HUMAN OTC DRUG Instant Hand Sanitizer Fresh Aloe ETHYL ALCOHOL GEL TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part333E BB17, LLC ALCOHOL 62 mL/100mL N 20181231 53603-2011_83735c2f-7465-4941-87ff-5c587b6bfd62 53603-2011 HUMAN OTC DRUG Anti-bacterial Blue Raspberry Hand Triclosan SOAP TOPICAL 20121006 OTC MONOGRAPH NOT FINAL part333E BB17, LLC TRICLOSAN .3 g/100mL N 20181231 53603-2012_8c2f9c88-af45-4144-af58-1d44e7878517 53603-2012 HUMAN OTC DRUG Anti-bacterial Strawberry Kiss Hand Triclosan SOAP TOPICAL 20121006 OTC MONOGRAPH NOT FINAL part333E BB17, LLC TRICLOSAN .3 g/100mL N 20181231 53603-2013_8d2085df-6ea3-42a9-85b0-5eeaa509d603 53603-2013 HUMAN OTC DRUG Anti-bacterial Lemon Drop Hand Triclosan SOAP TOPICAL 20121006 OTC MONOGRAPH NOT FINAL part333E BB17, LLC TRICLOSAN .3 g/100mL N 20181231 53603-2014_ddf2a5b8-a5dc-4a5b-84a5-f9345bfa8e22 53603-2014 HUMAN OTC DRUG Anti-bacterial Bubble Gum Hand Triclosan SOAP TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333E BB17, LLC TRICLOSAN .3 g/100mL N 20181231 53603-2015_f22b9522-ce4f-4da3-8345-21e9b43ca265 53603-2015 HUMAN OTC DRUG Anti-bacterial Fresh Aloe Hand Triclosan SOAP TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part333E BB17, LLC TRICLOSAN .3 g/100mL N 20181231 53603-3001_88b59373-7254-413e-b85b-070e2156bb58 53603-3001 HUMAN OTC DRUG ANTIBACTERIAL WIPES Candy Apple benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g N 20181231 53603-3002_14a1d080-0ec1-4cf9-a6f5-b6a4bb225a17 53603-3002 HUMAN OTC DRUG ANTIBACTERIAL WIPES Lemon Drop benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g N 20181231 53603-3003_587eda8d-2818-47f3-8243-eba4f43f3941 53603-3003 HUMAN OTC DRUG ANTIBACTERIAL WIPES Blue Raspberry benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g N 20181231 53603-3004_0dce803a-47d7-42c7-8998-53e3cd498fd8 53603-3004 HUMAN OTC DRUG ANTIBACTERIAL WIPES Fresh Aloe benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g N 20181231 53603-4001_a7243afd-3136-489d-b601-dc121e56a978 53603-4001 HUMAN OTC DRUG ANTIBACTERIAL MINI WIPES Blue Raspberry benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g N 20181231 53603-4002_a3d1f732-a4eb-430d-aa8e-bb341985dd86 53603-4002 HUMAN OTC DRUG ANTIBACTERIAL MINI WIPES Candy Apple benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g N 20181231 53603-4003_7b7ea1e2-9077-47b7-a988-441c50302e26 53603-4003 HUMAN OTC DRUG ANTIBACTERIAL MINI WIPES Fresh Aloe benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g N 20181231 53603-4004_8a007018-d5f2-479a-adbb-4962a893eb17 53603-4004 HUMAN OTC DRUG ANTIBACTERIAL MINI WIPES Lemon Drop benzethonium chloride SWAB TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E BB17, LLC BENZETHONIUM CHLORIDE .2 g/100g N 20181231 53614-001_e53f15dd-98b1-4fc2-82c8-038bb057acf0 53614-001 HUMAN OTC DRUG ZHONG HUA JIU PATCH MENTHOL PATCH TOPICAL 20030515 OTC MONOGRAPH NOT FINAL part348 Wuhan Chinese Moxibustion Technology Development Co.; Ltd. MENTHOL 10 mg/1000mg E 20171231 53620-101_093cb8ba-cb5f-4837-8de7-42025df96c24 53620-101 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 19550101 UNAPPROVED MEDICAL GAS Esquire Gas Products Company, Inc CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 53622-001_6f970bc4-ef17-421b-83bc-b24e6d4308cf 53622-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 NDA NDA205865 Regional Home Care, Inc. OXYGEN 99 L/100L N 20181231 53633-100_e968331c-cc3d-46f4-b10b-e72929bdef3e 53633-100 HUMAN OTC DRUG Marly Skin Guard Dimethicone AEROSOL, FOAM TOPICAL 20121008 OTC MONOGRAPH NOT FINAL part356 Marly Skin NA Inc DIMETHICONE 1 g/100mL N 20181231 53634-010_2826812a-5562-418f-a5f3-67c113c7c669 53634-010 HUMAN OTC DRUG Malin and Goetz Acne Treatment sulfur CREAM TOPICAL 20121105 OTC MONOGRAPH FINAL part333D Malin and Goetz Inc SULFUR 10 g/100mL N 20191231 53634-125_7e6e8810-6a31-467d-96cc-b969542d18f4 53634-125 HUMAN OTC DRUG Acne treatment daytime Salicylic Acid CREAM TOPICAL 20180103 OTC MONOGRAPH FINAL part333D Malin and Goetz Inc SALICYLIC ACID 2 g/mL N 20191231 53634-127_a43ccf1d-f687-4930-905d-c2323dddb35f 53634-127 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20171204 OTC MONOGRAPH FINAL part358H Malin and Goetz Inc PYRITHIONE ZINC 1.9 g/100mL N 20191231 53634-152_96e96392-80f2-45f3-a3ae-d52a257f87a0 53634-152 HUMAN OTC DRUG Malin and Goetz SPF 15 face moisturizer Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20121002 OTC MONOGRAPH NOT FINAL part352 Malin & Goetz Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 2 g/100mL; g/100mL; g/100mL N 20181231 53634-254_42a636d3-b93f-4fad-ae6c-61be99e2afec 53634-254 HUMAN OTC DRUG Malin and Goetz SPF 30 Face Moisturizer avobenzone, homosalate, octinoxate, octisalate, and oxybenzone CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Malin + Goetz AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 100; 75; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53634-255_078cf6fb-d51c-402c-8982-fdd57ef0fb47 53634-255 HUMAN OTC DRUG SPF 30 face Moisturizer Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20171205 OTC MONOGRAPH FINAL part352 Malin and Goetz Inc AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 10; 7.5; 2.75; 5 g/100mL; g/100mL; g/100mL; 1/100mL; 1/100mL N 20191231 53645-1000_bd7a27d1-ffb1-4cbb-ae8f-cf30c92ce46a 53645-1000 HUMAN OTC DRUG Arnica Arnica LIQUID ORAL 20121113 UNAPPROVED HOMEOPATHIC True Botanica, LLC ARNICA MONTANA FLOWER 6 [hp_X]/50mL N 20181231 53645-1001_c08fef41-f4d1-4104-9d51-c20fbf76311c 53645-1001 HUMAN OTC DRUG Arnica Arnica montana GLOBULE ORAL 20130902 UNAPPROVED HOMEOPATHIC True Botanica, LLC ARNICA MONTANA 30 [hp_X]/23g N 20181231 53645-1010_61979c44-a376-6422-e053-2991aa0acc96 53645-1010 HUMAN OTC DRUG Stannum Metallicum Stannum Metallicum GLOBULE ORAL 20140203 UNAPPROVED HOMEOPATHIC True Botanica, LLC TIN 6 [hp_X]/23g N 20181231 53645-1011_6197db12-54b8-742c-e053-2a91aa0a3cee 53645-1011 HUMAN OTC DRUG Stannum Metallicum Stannum Metallicum GLOBULE ORAL 20140203 UNAPPROVED HOMEOPATHIC True Botanica, LLC TIN 30 [hp_X]/23g N 20181231 53645-1020_75fb53e3-6e68-4359-9469-d2ef1f807c1e 53645-1020 HUMAN OTC DRUG Aurum Metallicum Aurum Metallicum LIQUID ORAL 20130121 UNAPPROVED HOMEOPATHIC True Botanica, LLC GOLD 6 [hp_X]/50mL N 20181231 53645-1021_06973bc4-b951-4910-b1d4-16bae53ef0f7 53645-1021 HUMAN OTC DRUG Aurum Metallicum Aurum Metallicum GLOBULE ORAL 20130628 UNAPPROVED HOMEOPATHIC True Botanica, LLC GOLD 30 [hp_X]/23g N 20181231 53645-1030_cf297cf2-2c99-466f-a1f7-0887b976fd9f 53645-1030 HUMAN OTC DRUG Argentum Metallicum Argentum Metallicum LIQUID ORAL 20130129 UNAPPROVED HOMEOPATHIC True Botanica, LLC SILVER 6 [hp_X]/50mL N 20181231 53645-1031_26587dbc-080a-4cb7-84a7-a74f45cbb82f 53645-1031 HUMAN OTC DRUG Argentum Metallicum Argentum Metallicum GLOBULE ORAL 20130628 UNAPPROVED HOMEOPATHIC True Botanica, LLC SILVER 30 [hp_X]/23g N 20181231 53645-1040_82ed880a-08ea-4826-a087-5b5fb5d9f983 53645-1040 HUMAN OTC DRUG Adrenal Adrenal LIQUID ORAL 20130208 UNAPPROVED HOMEOPATHIC True Botanica, LLC BOS TAURUS ADRENAL GLAND 6 [hp_X]/50mL N 20181231 53645-1050_7b2ef0fb-88e8-477b-bce6-a6725aca7fc5 53645-1050 HUMAN OTC DRUG Cuprum Metallicum Cuprum Metallicum CREAM TOPICAL 20130227 UNAPPROVED HOMEOPATHIC True Botanica, LLC COPPER 6 [hp_X]/50mL N 20181231 53645-1060_ae9968f1-c7b7-4be1-91e3-8de15b4b8ec9 53645-1060 HUMAN OTC DRUG Stannum Metallicum Stannum Metallicum CREAM TOPICAL 20130312 UNAPPROVED HOMEOPATHIC True Botanica, LLC TIN 6 [hp_X]/50mL N 20181231 53645-1070_fd03e4df-c0eb-4e48-a4c7-4effdc664707 53645-1070 HUMAN OTC DRUG Argentum Metallicum Argentum Metallicum CREAM TOPICAL 20130312 UNAPPROVED HOMEOPATHIC True Botanica, LLC SILVER 6 [hp_X]/50mL N 20181231 53645-1080_2a74d35e-9b7d-4c39-bb5f-df55d70f564a 53645-1080 HUMAN OTC DRUG Ferrum Metallicum Ferrum Metallicum CREAM TOPICAL 20130312 UNAPPROVED HOMEOPATHIC True Botanica, LLC IRON 6 [hp_X]/50mL N 20181231 53645-1090_0dc86c33-f12d-4ebc-91fb-77f947f39c55 53645-1090 HUMAN OTC DRUG Lycopodium Clavatum Lycopodium Clavatum GLOBULE ORAL 20131007 UNAPPROVED HOMEOPATHIC True Botanica, LLC LYCOPODIUM CLAVATUM SPORE 6 [hp_X]/23g N 20181231 53645-1091_13856b44-f38a-4825-858b-3d7d19d4597d 53645-1091 HUMAN OTC DRUG Lycopodium Clavatum Lycopodium Clavatum GLOBULE ORAL 20131007 UNAPPROVED HOMEOPATHIC True Botanica, LLC LYCOPODIUM CLAVATUM SPORE 30 [hp_X]/23g N 20181231 53645-1100_a9e9bbac-892d-40f8-8385-bdffce576452 53645-1100 HUMAN OTC DRUG Cuprum Metallicum Cuprum Metallicum GLOBULE ORAL 20130628 UNAPPROVED HOMEOPATHIC True Botanica, LLC COPPER 6 [hp_X]/23g N 20181231 53645-1101_61942272-565a-6413-e053-2a91aa0ae767 53645-1101 HUMAN OTC DRUG Cuprum Metallicum Cuprum Metallicum GLOBULE ORAL 20140203 UNAPPROVED HOMEOPATHIC True Botanica, LLC COPPER 30 [hp_X]/23g N 20181231 53645-1110_7c991535-a53d-42bc-8ddb-e90ec7ab7f2c 53645-1110 HUMAN OTC DRUG Belladonna Belladonna GLOBULE ORAL 20130607 UNAPPROVED HOMEOPATHIC True Botanica, LLC ATROPA BELLADONNA 30 [hp_X]/23g N 20181231 53645-1111_f0848ff6-f094-4012-bd07-e45e205cc1b2 53645-1111 HUMAN OTC DRUG Belladonna Belladonna GLOBULE ORAL 20130607 UNAPPROVED HOMEOPATHIC True Botanica, LLC ATROPA BELLADONNA 6 [hp_X]/23g N 20181231 53645-1120_32d71f4c-418a-4ce8-acb9-c8f353b65ab7 53645-1120 HUMAN OTC DRUG Antimonium Crudum Antimonium Crudum GLOBULE ORAL 20130902 UNAPPROVED HOMEOPATHIC True Botanica, LLC ANTIMONY TRISULFIDE 6 [hp_X]/23g N 20181231 53645-1140_f5eb452f-d132-463e-a215-a757d74caec2 53645-1140 HUMAN OTC DRUG Apis Mell. Apis Mell. GLOBULE ORAL 20130620 UNAPPROVED HOMEOPATHIC True Botanica, LLC APIS MELLIFERA VENOM 6 [hp_X]/23g N 20181231 53645-1141_1e036ad1-6fe8-4fd5-87ad-8eb686be9074 53645-1141 HUMAN OTC DRUG Apis Mell. Apis Mell. 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53645-2000_6199ad50-40b5-4fee-e053-2991aa0aaf5e 53645-2000 HUMAN OTC DRUG Drosera Drosera GLOBULE ORAL 20140203 UNAPPROVED HOMEOPATHIC True Botanica, LLC DROSERA INTERMEDIA 6 [hp_X]/23g N 20181231 53645-2040_61997e4b-3f68-26f8-e053-2a91aa0aec6f 53645-2040 HUMAN OTC DRUG Stramonium Stramonium GLOBULE ORAL 20140203 UNAPPROVED HOMEOPATHIC True Botanica, LLC DATURA STRAMONIUM 30 [hp_X]/23g N 20181231 53645-2050_619936c5-08f6-b976-e053-2991aa0ad66c 53645-2050 HUMAN OTC DRUG Anagallis Arvensis Anagallis Arvensis GLOBULE ORAL 20140203 UNAPPROVED HOMEOPATHIC True Botanica, LLC ANAGALLIS ARVENSIS 30 [hp_X]/23g N 20181231 53645-2051_6199ad50-4090-4fee-e053-2991aa0aaf5e 53645-2051 HUMAN OTC DRUG Anagallis Arvensis Anagallis Arvensis GLOBULE ORAL 20140203 UNAPPROVED HOMEOPATHIC True Botanica, LLC ANAGALLIS ARVENSIS 30 [hp_X]/23g N 20181231 53645-2060_619a2c9a-4c7e-1f67-e053-2a91aa0a0408 53645-2060 HUMAN OTC DRUG Kali Carb Kali Carb GLOBULE ORAL 20140505 UNAPPROVED HOMEOPATHIC True Botanica, LLC POTASSIUM CARBONATE 6 [hp_X]/23g N 20181231 53645-2070_61997e4b-3f8b-26f8-e053-2a91aa0aec6f 53645-2070 HUMAN OTC DRUG Helleborus Niger Helleborus Niger GLOBULE ORAL 20140203 UNAPPROVED HOMEOPATHIC True Botanica, LLC HELLEBORUS NIGER ROOT 6 [hp_X]/23g N 20181231 53645-2080_619a3982-a374-7c26-e053-2991aa0a57ec 53645-2080 HUMAN OTC DRUG Helleborus Niger Helleborus Niger GLOBULE ORAL 20140203 UNAPPROVED HOMEOPATHIC True Botanica, LLC HELLEBORUS NIGER ROOT 29 [hp_X]/23g N 20181231 53645-2090_61992670-f776-7448-e053-2a91aa0acf79 53645-2090 HUMAN OTC DRUG Viscum Album Viscum Album GLOBULE ORAL 20140203 UNAPPROVED HOMEOPATHIC True Botanica, LLC VISCUM ALBUM FRUITING TOP 25 [hp_X]/23g N 20181231 53663-0001_4248aae0-ec1c-451a-a2df-fe7cfff9fb9d 53663-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850715 UNAPPROVED MEDICAL GAS Sonora Regional Medical Center dba Sonora Oxygen & Medical Supply OXYGEN 99 L/100L E 20171231 53666-100_c5cec0f6-56ff-4544-a932-a133ad26c2d4 53666-100 HUMAN OTC DRUG Alka Seltzer ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20121010 OTC MONOGRAPH FINAL part343 Salimex, S.A. ASPIRIN; ANHYDROUS CITRIC ACID; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 E 20171231 53666-403_c5cec0f6-56ff-4544-a932-a133ad26c2d4 53666-403 HUMAN OTC DRUG Alka Seltzer ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20121010 OTC MONOGRAPH FINAL part343 Salimex, S.A. ASPIRIN; ANHYDROUS CITRIC ACID; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 N 20181231 53666-408_b09519e5-436d-4e8d-9183-fa3d17a09dc1 53666-408 HUMAN OTC DRUG TABCIN 500 Acetylsalicylic Acid, Phenylephrine Bitartrate, Chlorpheniramine maleate TABLET, EFFERVESCENT ORAL 20130821 OTC MONOGRAPH FINAL part341 Salimex, S.A. ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE 500; 8; 2 mg/1; mg/1; mg/1 N 20181231 53666-417_5bed3736-7cb5-9fa0-e053-2a91aa0a0463 53666-417 HUMAN OTC DRUG Desenfriol-D CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN TABLET ORAL 20171018 OTC MONOGRAPH FINAL part341 Salimex, S.A. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN .002; .005; .5 g/g; g/g; g/g N 20181231 53666-444_d9d0b2bf-f514-4370-92cb-ecba0e49e9ed 53666-444 HUMAN OTC DRUG TABCIN 500 ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20130821 OTC MONOGRAPH FINAL part343 Salimex, S.A. ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE 500; 8; 2 mg/1; mg/1; mg/1 N 20181231 53666-617_5bee1a0b-7c7a-cdca-e053-2991aa0a95ed 53666-617 HUMAN OTC DRUG Desenfriol-D CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN TABLET ORAL 20171018 OTC MONOGRAPH FINAL part341 Salimex, S.A. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN .002; .005; .5 g/g; g/g; g/g N 20181231 53675-100_7abdab3e-6427-49bd-b108-8c898fa8852a 53675-100 HUMAN OTC DRUG ARUBA ALOE ISLAND REMEDY DAILY ULTRA ALOE OCTINOXATE, OXYBENZONE CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 ARUBA ALOE BALM NV OCTINOXATE; OXYBENZONE 7.5; 4.5 mL/100mL; mL/100mL N 20181231 53675-131_635f8720-a865-4ec3-e053-2a91aa0afbe2 53675-131 HUMAN OTC DRUG Aruba Aloe Deodorant Ladies Extra Dry Aluminum Chlorohydrate LOTION TOPICAL 20070101 20180901 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV ALUMINUM CHLOROHYDRATE 25 g/100g N 20191231 53675-132_635f8720-a870-4ec3-e053-2a91aa0afbe2 53675-132 HUMAN OTC DRUG Aruba Aloe Deodorant Men Extra Dry Aluminum Chlorohydrate LOTION TOPICAL 20070101 20180901 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV ALUMINUM CHLOROHYDRATE 25 g/100g N 20191231 53675-133_4e409aac-c491-4112-bb9e-ff7ba28b91ca 53675-133 HUMAN OTC DRUG Aruba Aloe Deodorant Men Musk Aluminum Chlorohydrate LOTION TOPICAL 20070101 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV ALUMINUM CHLOROHYDRATE 16 g/100g N 20181231 53675-134_4aa884f3-497e-49d6-b2b7-f34b159994b0 53675-134 HUMAN OTC DRUG Aruba Aloe Deodorant Women Powder Fresh Aluminum Chlorohydrate LOTION TOPICAL 20070101 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV ALUMINUM CHLOROHYDRATE 16 g/100g N 20181231 53675-140_0d0212db-df23-4ebf-abb5-c1148ffeb320 53675-140 HUMAN OTC DRUG Aruba Aloe Lip Sunscreen and Moisturizer OXYBENZONE, PADIMATE LIPSTICK TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV OXYBENZONE; PADIMATE O 3; 8 g/100g; g/100g N 20181231 53675-150_3b7cec17-9185-4d27-a4c4-1a3c498e82d6 53675-150 HUMAN OTC DRUG Aruba Aloe Very Water Resistant Sunscreen HOMOSALATE, OCTINOXATE, PADIMATE O , OXYBENZONE LOTION TOPICAL 20110605 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm, NV HOMOSALATE; OCTINOXATE; PADIMATE O; OXYBENZONE 8; 7; 4.2; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 53675-152_7345afe5-fae3-46c6-8485-e0a739f8dd4e 53675-152 HUMAN OTC DRUG Aruba Aloe Very Water Resistant Sunscreen For Kids SPF 30 HOMOSALATE, OCTINOXATE, PADIMATE O , OXYBENZONE LOTION TOPICAL 20110605 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm, NV HOMOSALATE; OCTINOXATE; PADIMATE O; OXYBENZONE 8; 7; 4.2; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 53675-154_1c240b7f-317f-4e06-89dc-198669ab7436 53675-154 HUMAN OTC DRUG Aruba Aloe Very Water Resistant Sunscreen - For Faces SPF 30 HOMOSALATE, OCTINOXATE, PADIMATE O, OXYBENZONE LOTION TOPICAL 20110706 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV HOMOSALATE; OCTINOXATE; PADIMATE O; OXYBENZONE 8; 7; 4.2; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 53675-155_16307d64-b3e8-4e0f-9170-0fc48c9d9068 53675-155 HUMAN OTC DRUG Aruba Aloe Very Water Resistant Sunscreen SPF 15 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm, NV OXYBENZONE; OCTINOXATE 4.5; 7.5 mL/100mL; mL/100mL N 20181231 53675-157_f712eb74-2f2c-4466-b4fb-06a92181c554 53675-157 HUMAN OTC DRUG Aruba Aloe Very Water Resistant Sunscreen SPF 8 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm, NV OXYBENZONE; OCTINOXATE 2; 7 mL/100mL; mL/100mL N 20181231 53675-158_c7886d9a-475f-45f0-ab6b-15cc3fb35667 53675-158 HUMAN OTC DRUG Aruba Aloe Very Water Resistant Sunscreen SPF 50 OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE, OCTYL SALICYLATE, AVOBENZONE LOTION TOPICAL 20130226 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV OCTOCRYLENE; OCTINOXATE; OXYBENZONE; HOMOSALATE; OCTISALATE; AVOBENZONE 100; 75; 60; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53675-160_33d7d1b8-b388-17d2-e054-00144ff8d46c 53675-160 HUMAN OTC DRUG Island Remedy All-day Revitalizing Moisturizer with SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20160524 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV TITANIUM DIOXIDE; ZINC OXIDE 57.8; 37.4 mg/mL; mg/mL N 20181231 53675-161_50fe88bd-f132-5fad-e054-00144ff8d46c 53675-161 HUMAN OTC DRUG Antiperspirant Deodorant Extra Dry Men ALUMINUM CHLOROHYDRATE LOTION TOPICAL 20170601 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV ALUMINUM CHLOROHYDRATE 250 mg/mL N 20181231 53675-162_50fe88bd-f13f-5fad-e054-00144ff8d46c 53675-162 HUMAN OTC DRUG Antiperspirant Deodorant Extra Dry Women ALUMINUM CHLOROHYDRATE LOTION TOPICAL 20170601 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV ALUMINUM CHLOROHYDRATE 250 mg/mL N 20181231 53675-163_50fe88bd-f123-5fad-e054-00144ff8d46c 53675-163 HUMAN OTC DRUG Antiperspirant Deodorant Fresh Women ALUMINUM CHLOROHYDRATE LOTION TOPICAL 20170601 OTC MONOGRAPH FINAL part350 Aruba Aloe Balm NV ALUMINUM CHLOROHYDRATE 160 mg/mL N 20181231 53675-164_5fc8dc04-c74e-1c43-e053-2991aa0a104b 53675-164 HUMAN OTC DRUG Alcoholada Pain Relieving LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20170610 OTC MONOGRAPH NOT FINAL part348 Aruba Aloe Balm NV LIDOCAINE HYDROCHLORIDE 5 mg/mL N 20181231 53675-165_5fc8ccf5-f578-048e-e053-2a91aa0a6263 53675-165 HUMAN OTC DRUG Sunscreen SPF 50 Plus Broad Spectrum UVA UVB protection AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20170610 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 75; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53675-170_5c77bc11-17f7-3f1a-e053-2a91aa0a857d 53675-170 HUMAN OTC DRUG Broad Spectrum SPF 30 Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20171025 OTC MONOGRAPH NOT FINAL part348 Aruba Aloe Balm NV TITANIUM DIOXIDE; ZINC OXIDE 80; 100 mg/mL; mg/mL N 20181231 53675-171_5c77bc11-1806-3f1a-e053-2a91aa0a857d 53675-171 HUMAN OTC DRUG Broad Spectrum Water Resistant SPF 50 Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20171025 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV TITANIUM DIOXIDE; ZINC OXIDE 100; 100 mg/mL; mg/mL N 20181231 53675-172_5c77bc11-1815-3f1a-e053-2a91aa0a857d 53675-172 HUMAN OTC DRUG Broad Spectrum Water Resistant SPF 50 Mineral Sunscreen Babies TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20171025 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV TITANIUM DIOXIDE; ZINC OXIDE 100; 100 mg/mL; mg/mL N 20181231 53675-173_5c777635-df09-6955-e053-2a91aa0a3aee 53675-173 HUMAN OTC DRUG Alcoholada Gel Pain Relieving Pain LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20171025 OTC MONOGRAPH NOT FINAL part348 Aruba Aloe Balm NV LIDOCAINE HYDROCHLORIDE 5 mg/mL N 20181231 53675-174_5c77dd2e-34ef-c738-e053-2991aa0a89f0 53675-174 HUMAN OTC DRUG Broad Spectrum Water Resistant SPF 30 Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20171025 OTC MONOGRAPH NOT FINAL part348 Aruba Aloe Balm NV TITANIUM DIOXIDE; ZINC OXIDE 80; 100 mg/mL; mg/mL N 20181231 53675-175_5c77b15c-50a5-2e00-e053-2a91aa0aee50 53675-175 HUMAN OTC DRUG Broad Spectrum Water Resistant SPF 50 Mineral Sunscreen Faces TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20171025 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV TITANIUM DIOXIDE; ZINC OXIDE 100; 100 mg/mL; mg/mL N 20181231 53675-176_5c77dd2e-3510-c738-e053-2991aa0a89f0 53675-176 HUMAN OTC DRUG Broad Spectrum SPF 50 Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20171025 OTC MONOGRAPH NOT FINAL part352 Aruba Aloe Balm NV TITANIUM DIOXIDE; ZINC OXIDE 100; 100 mg/mL; mg/mL N 20181231 53683-0001_9a581f45-ff98-4d2a-8b62-12a5f715fd7f 53683-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870101 UNAPPROVED MEDICAL GAS MEDOX CORPORATION OXYGEN 99 L/100L E 20171231 53698-001_3e61be70-5f83-447b-b27e-8b78bdce2518 53698-001 HUMAN OTC DRUG Premium Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20121010 OTC MONOGRAPH NOT FINAL part352 Pro Sun Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 60 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 53703-800_a81ed77a-1ea5-4399-a2a4-bf8a3c3240a7 53703-800 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride SYRUP ORAL 20150427 ANDA ANDA040169 Entera Health, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 53720-001_a7ea70b0-fb1c-43dd-ba01-0081dd4854a0 53720-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19640101 UNAPPROVED MEDICAL GAS Dennis Welding Supply, Inc. OXYGEN 99 L/100L N 20181231 53723-0001_e9303f81-b3d5-4246-bb1e-dbe3a0c11b99 53723-0001 HUMAN OTC DRUG NatuRx Symphytum Officinale, Capsicum Annuum, Ledum Palustre, Colchicum Autumnale, Rhododendron Chrysanthum GEL TOPICAL 20130422 UNAPPROVED HOMEOPATHIC DrsOnlyLab LLC COMFREY ROOT; CAPSICUM; LEDUM PALUSTRE TWIG; COLCHICUM AUTUMNALE BULB; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 3; 6; 6; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 53727-101_a2ce1edd-0109-45ca-a77d-3181fbb69a23 53727-101 HUMAN OTC DRUG Always Triple BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Cosmecca Korea Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5; .5 g/50g; g/50g N 20181231 53727-102_7e815d78-c112-4d24-a5b0-e396358c4964 53727-102 HUMAN OTC DRUG Premium Gold Mineral BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Cosmecca Korea Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5; 3 g/50g; g/50g N 20181231 53727-103_8a40ce01-f850-4711-94fd-5176f75f58d9 53727-103 HUMAN OTC DRUG Time Machine BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Cosmecca Korea Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 3; 2 g/30g; g/30g N 20181231 53727-104_e42fc858-3e3d-4aa9-b106-1dc063b44e94 53727-104 HUMAN OTC DRUG Always Nuddy CC Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Cosmecca Korea Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 4; 1 g/50g; g/50g N 20181231 53727-105_7a393fd9-a193-4613-bfcc-e86b0c15e93f 53727-105 HUMAN OTC DRUG Always Perfect CC Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140529 OTC MONOGRAPH FINAL part352 Cosmecca Korea Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5; 3 g/50g; g/50g N 20181231 53729-0001_d500f555-78a4-4bdf-ade4-6a68c9dd4182 53729-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19790218 UNAPPROVED MEDICAL GAS Buckeye Welding Supply Co Inc. OXYGEN 99 L/100L N 20181231 53730-001_25ad84b3-3b72-4541-b8cd-fea338e0222b 53730-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19840101 NDA NDA205889 Clovis Equipment & Supply Company OXYGEN 99 L/100L N 20181231 53738-0711_5489d56c-1a4d-477d-a288-742388fdd78d 53738-0711 HUMAN OTC DRUG RoC Retinol Correxion Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120828 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Sante Beaute- France AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 30; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53738-0712_7822b340-a62e-4582-8ad5-1074ebb4513f 53738-0712 HUMAN OTC DRUG RoC Multi correxion Lift Anti Gravity Day Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120607 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Sante Beaute- France AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53738-0713_39857372-0ae4-48a3-9039-982878c273cb 53738-0713 HUMAN OTC DRUG RoC Multi Correxion 5 in 1 Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Sante Beaute- France AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53742-001_d5b56202-f65a-43aa-916c-ce99e155ddcc 53742-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19991221 UNAPPROVED MEDICAL GAS Cumberland Medical Center- Medical Equipment Services OXYGEN 99 L/100L E 20171231 53746-077_80781c80-37a9-4b91-8cd9-8346d5d0c7c8 53746-077 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET ORAL 20100922 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals, LLC ESTROGENS, CONJUGATED; METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 53746-078_80781c80-37a9-4b91-8cd9-8346d5d0c7c8 53746-078 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET ORAL 20100922 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals, LLC ESTROGENS, CONJUGATED; METHYLTESTOSTERONE 1.25; 2.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 53746-101_13c7f550-e828-4baa-97fe-ecc9f8dd817e 53746-101 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Amneal Pharmaceuticals of New York LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53746-102_13c7f550-e828-4baa-97fe-ecc9f8dd817e 53746-102 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Amneal Pharmaceuticals of New York LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53746-103_13c7f550-e828-4baa-97fe-ecc9f8dd817e 53746-103 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Amneal Pharmaceuticals of New York LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53746-109_8021e0d1-d2b5-4fb9-99fc-b33d76ec36f6 53746-109 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 Amneal Pharmaceuticals of New York LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 53746-110_945a469e-726e-454c-90ea-708557f2ac3b 53746-110 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040746 Amneal Pharmaceuticals of New York LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 53746-116_da873b1f-22bc-4158-817e-0672a1107109 53746-116 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Amneal Pharmaceuticals of New York LLC HYDROCODONE BITARTRATE; IBUPROFEN 2.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 53746-117_da873b1f-22bc-4158-817e-0672a1107109 53746-117 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Amneal Pharmaceuticals of New York LLC HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 53746-140_2d202e25-8db1-4a89-baf9-194ce169ebe0 53746-140 HUMAN OTC DRUG Ibuprofen Pain Releiver/ Fever Reducer Ibuprofen TABLET ORAL 20091216 ANDA ANDA071333 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 200 mg/1 N 20181231 53746-142_2d748080-2d3f-4208-8435-0bcab549ffd5 53746-142 HUMAN OTC DRUG Ibuprofen (NSAID) Pain Releiver/ Fever Reducer Ibuprofen TABLET ORAL 20091216 ANDA ANDA072199 Amneal Pharmaceuticals IBUPROFEN 200 mg/1 N 20181231 53746-143_2d202e25-8db1-4a89-baf9-194ce169ebe0 53746-143 HUMAN OTC DRUG Ibuprofen Pain Releiver/ Fever Reducer Ibuprofen TABLET ORAL 20091216 ANDA ANDA071333 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 200 mg/1 N 20181231 53746-144_2d748080-2d3f-4208-8435-0bcab549ffd5 53746-144 HUMAN OTC DRUG Ibuprofen (NSAID) Pain Releiver/ Fever Reducer Ibuprofen TABLET ORAL 20091216 ANDA ANDA072199 Amneal Pharmaceuticals IBUPROFEN 200 mg/1 N 20181231 53746-145_da873b1f-22bc-4158-817e-0672a1107109 53746-145 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Amneal Pharmaceuticals of New York LLC HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 53746-146_da873b1f-22bc-4158-817e-0672a1107109 53746-146 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Amneal Pharmaceuticals of New York LLC HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 53746-169_104844a1-c022-4104-be63-b6a01984f912 53746-169 HUMAN PRESCRIPTION DRUG Memantine hydrochloride Memantine TABLET, FILM COATED ORAL 20150430 ANDA ANDA090041 Amneal Pharmaceuticals of New York LLC MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 53746-173_104844a1-c022-4104-be63-b6a01984f912 53746-173 HUMAN PRESCRIPTION DRUG Memantine hydrochloride Memantine TABLET, FILM COATED ORAL 20150430 ANDA ANDA090041 Amneal Pharmaceuticals of New York LLC MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 53746-178_2aeb642b-f844-4768-bb5b-066a4b8e50d6 53746-178 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 Amneal Pharmaceuticals of New York LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 53746-179_2aeb642b-f844-4768-bb5b-066a4b8e50d6 53746-179 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100226 ANDA ANDA078596 Amneal Pharmaceuticals of New York LLC METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 53746-188_802aab0e-b844-4a91-952b-0cb12b4de33a 53746-188 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Amneal Pharmaceuticals of New York, LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53746-189_802aab0e-b844-4a91-952b-0cb12b4de33a 53746-189 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Amneal Pharmaceuticals of New York, LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53746-190_802aab0e-b844-4a91-952b-0cb12b4de33a 53746-190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Amneal Pharmaceuticals of New York, LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53746-191_91f51db3-1369-49b1-b785-18e55a23dab4 53746-191 HUMAN OTC DRUG Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever Naproxen Sodium TABLET ORAL 20091125 ANDA ANDA079096 Amneal Pharmaceuticals NAPROXEN SODIUM 220 mg/1 N 20181231 53746-192_91f51db3-1369-49b1-b785-18e55a23dab4 53746-192 HUMAN OTC DRUG Naproxen Sodium (NSAID) Fever Reducer/ Pain Reliever Naproxen Sodium TABLET ORAL 20091125 ANDA ANDA079096 Amneal Pharmaceuticals NAPROXEN SODIUM 220 mg/1 N 20181231 53746-193_748fb0fe-0b74-4fe7-b691-0a89d4c79103 53746-193 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Amneal Pharmaceuticals of New York LLC NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53746-194_748fb0fe-0b74-4fe7-b691-0a89d4c79103 53746-194 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Amneal Pharmaceuticals of New York LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53746-203_bca49d17-6aad-4b23-9bed-75d378ee6fdd 53746-203 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 Amneal Pharmaceuticals of New York LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 53746-204_0fa6e7d7-97f6-4a98-92fb-c7e82aafc5b6 53746-204 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040778 Amneal Pharmaceuticals of New York LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 53746-218_09574aec-1304-4ee1-ac09-01e7b86cfb75 53746-218 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 Amneal Pharmaceuticals of New York, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 53746-219_09574aec-1304-4ee1-ac09-01e7b86cfb75 53746-219 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 Amneal Pharmaceuticals of New York, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 53746-220_09574aec-1304-4ee1-ac09-01e7b86cfb75 53746-220 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 Amneal Pharmaceuticals of New York, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 53746-226_7036a3c4-0b48-485a-ab7a-5eb0f0332ed0 53746-226 HUMAN PRESCRIPTION DRUG Estradiol Estradiol INSERT VAGINAL 20150607 ANDA ANDA205256 Amneal Pharmaceuticals of New York LLC ESTRADIOL 10 ug/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 53746-253_7bd05190-1cff-4c00-b9b8-dd65ac437f03 53746-253 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Amneal Pharmaceuticals of New York, LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 53746-254_7bd05190-1cff-4c00-b9b8-dd65ac437f03 53746-254 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Amneal Pharmaceuticals of New York, LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 53746-271_2c440ad0-c279-4182-aba8-0f8724b926bb 53746-271 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100225 ANDA ANDA076899 Amneal Pharmaceuticals of New York, LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 53746-272_2c440ad0-c279-4182-aba8-0f8724b926bb 53746-272 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Amneal Pharmaceuticals of New York, LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 53746-291_d834013a-d7ca-4674-994e-a8d634111242 53746-291 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20160925 ANDA ANDA204415 Amneal Pharmaceuticals of New York LLC TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 53746-292_d834013a-d7ca-4674-994e-a8d634111242 53746-292 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20160925 ANDA ANDA204415 Amneal Pharmaceuticals of New York LLC TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 53746-293_d834013a-d7ca-4674-994e-a8d634111242 53746-293 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20160925 ANDA ANDA204415 Amneal Pharmaceuticals of New York LLC TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 53746-464_e75c2268-ef90-40e4-8120-f198e486cbc1 53746-464 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53746-465_e75c2268-ef90-40e4-8120-f198e486cbc1 53746-465 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53746-466_e75c2268-ef90-40e4-8120-f198e486cbc1 53746-466 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53746-511_ee4b69ee-5d2a-4344-a87f-156bc402edce 53746-511 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Amneal Pharmaceuticals of New York, LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 53746-514_ee4b69ee-5d2a-4344-a87f-156bc402edce 53746-514 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Amneal Pharmaceuticals of New York, LLC SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 53746-515_ee4b69ee-5d2a-4344-a87f-156bc402edce 53746-515 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Amneal Pharmaceuticals of New York, LLC SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 53746-542_bb583a6e-acd8-4c7f-a05e-752b436a1193 53746-542 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20130222 ANDA ANDA202128 Amneal Pharmaceuticals of New York LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 53746-544_98ac2856-f82d-4638-90bb-13c943b7baf6 53746-544 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20091224 ANDA ANDA040866 Amneal Pharmaceuticals of New York LLC PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53746-545_98ac2856-f82d-4638-90bb-13c943b7baf6 53746-545 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20091224 ANDA ANDA040866 Amneal Pharmaceuticals of New York LLC PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53746-553_c006d438-b210-41ff-966d-6064cae8b6be 53746-553 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20130531 ANDA ANDA203399 Amneal Pharmaceuticals of New York, LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 53746-617_d44ac50e-b489-4b58-bbd2-aabbeb8223d7 53746-617 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Amneal Pharmaceuticals of New York, LLC TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 53746-669_e99ebf24-cd59-4dfb-bbd7-d2401fa7ec22 53746-669 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091201 ANDA ANDA075047 Amneal Pharmaceuticals of New York LLC ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 53746-670_e99ebf24-cd59-4dfb-bbd7-d2401fa7ec22 53746-670 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091201 ANDA ANDA075047 Amneal Pharmaceuticals of New York LLC ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 53746-955_96bf1146-b1e0-4f8d-a8c0-976471c2e292 53746-955 HUMAN PRESCRIPTION DRUG Esomeprazole strontium Esomeprazole strontium CAPSULE, DELAYED RELEASE ORAL 20130812 NDA NDA202342 Amneal Pharmaceuticals, LLC ESOMEPRAZOLE STRONTIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 53746-957_96bf1146-b1e0-4f8d-a8c0-976471c2e292 53746-957 HUMAN PRESCRIPTION DRUG Esomeprazole strontium Esomeprazole strontium CAPSULE, DELAYED RELEASE ORAL 20130812 NDA NDA202342 Amneal Pharmaceuticals, LLC ESOMEPRAZOLE STRONTIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 53748-0001_a2c0b63f-689b-45a7-ac0a-071f97f865df 53748-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20031126 UNAPPROVED MEDICAL GAS GoodCare by CPCI OXYGEN 99 L/100L E 20171231 53755-100_4833b0b1-33b4-59d4-e054-00144ff8d46c 53755-100 HUMAN OTC DRUG SERIOUS SKINCARE SERIOUS-C3 PLASMA TM BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30 AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20170208 OTC MONOGRAPH NOT FINAL part352 Flageoli Limited AVOBENZONE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 27; 75; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53755-101_4d11cc46-393f-1561-e054-00144ff8d46c 53755-101 HUMAN OTC DRUG SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30 AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20170413 OTC MONOGRAPH NOT FINAL part352 Flageoli Limited AVOBENZONE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 27; 75; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53755-110_5f4f878c-ecea-467f-e053-2991aa0a0c6a 53755-110 HUMAN OTC DRUG Serious Skincare Continuously Clear Acne Medication For Problematic skin Dry Lo Pro All- Over Treatment SALICYLIC ACID LOTION TOPICAL 20171201 OTC MONOGRAPH FINAL part333D Flageoli Limited SALICYLIC ACID 10 mg/mL N 20181231 53773-001_9a230db4-393e-41c1-affd-59927ad06cbd 53773-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Eastern Medical Equipment OXYGEN 99 L/100L E 20171231 53777-001_33b79ad0-1d69-4422-bf9e-70c3d342610e 53777-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19791101 NDA NDA205865 Thompson Brothers Supplies Inc OXYGEN 990 mL/L N 20181231 53791-118_e8e1c1f5-cd50-4b7f-bf68-9808e9cb277d 53791-118 HUMAN OTC DRUG Alhua Huogan Pain Relieving Patch Menthol PATCH TOPICAL 20130205 OTC MONOGRAPH NOT FINAL part348 U.S.A. AH LLC MENTHOL 30 mg/1 E 20171231 53798-010_61e8be8a-abd1-4716-9003-56562b2bba94 53798-010 HUMAN OTC DRUG SKYLAKE ORIENTAL HERB EYE Witch Hazel CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part347 SKYLAKE WITCH HAZEL .02 g/20mL N 20181231 53807-123_e24d8ff7-8d62-4d25-a337-de885eb47e02 53807-123 HUMAN OTC DRUG Anti-Fungal TOLNAFTATE POWDER TOPICAL 19990316 OTC MONOGRAPH FINAL part333C Rij Pharmaceutical Corporation TOLNAFTATE .45 g/45g E 20171231 53807-125_a1bae7e7-2204-4712-b687-5273f2aa49c6 53807-125 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide LIQUID ORAL 19990316 OTC MONOGRAPH NOT FINAL part334 Rij Pharmaceutical Corporation MAGNESIUM HYDROXIDE 1200 mg/15mL E 20171231 53807-126_bbe98d8b-cd81-4ddd-97b6-506e68508836 53807-126 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL E 20171231 53807-129_fd15ec29-3ff3-41bc-914e-0729638f559a 53807-129 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen ELIXIR ORAL 19990316 OTC MONOGRAPH NOT FINAL part343 Rij Pharmaceutical Corporation ACETAMINOPHEN 160 mg/5mL E 20171231 53807-137_e15ed437-efbe-4fe3-8726-b0a9772e5aad 53807-137 HUMAN OTC DRUG RIGINIC ANTACID LIQUID aluminum hydroxide and magnesium carbonate LIQUID ORAL 20130403 OTC MONOGRAPH FINAL part331 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 95; 358 mg/15mL; mg/15mL E 20171231 53807-151_a5bd1783-d2d8-42de-84c0-55bbc7ff7c74 53807-151 HUMAN OTC DRUG antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 225; 200; 25 mg/5mL; mg/5mL; mg/5mL E 20171231 53807-152_bd0d464d-4218-4c04-b48b-a582913b577d 53807-152 HUMAN OTC DRUG Bismuth Bismuth Subsalicylate LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part335 Rij Pharmaceutical Corporation BISMUTH SUBSALICYLATE 262 mg/15mL E 20171231 53807-158_b5a1a812-bf99-490a-869a-7adc3c9e76be 53807-158 HUMAN OTC DRUG antacid double strength Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL E 20171231 53807-177_e40f40eb-b40b-476b-ab90-3338bb60cd26 53807-177 HUMAN OTC DRUG FERROUS SULFATE FERROUS SULFATE ELIXIR ORAL 19990316 UNAPPROVED DRUG OTHER Rij Pharmaceutical Corporation FERROUS SULFATE 220 mg/5mL E 20171231 53807-192_cca5cf8f-8f49-42ca-9f6f-2e9ea7b91ec6 53807-192 HUMAN OTC DRUG Pink Bismuth Maximum Strength Bismuth Subsalicylate LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part335 Rij Pharmaceutical Corporation BISMUTH SUBSALICYLATE 525 mg/15mL E 20171231 53807-196_b526e318-ee7d-47a8-b8c9-50a273258fec 53807-196 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen ELIXIR ORAL 19990316 OTC MONOGRAPH NOT FINAL part343 Rij Pharmaceutical Corporation ACETAMINOPHEN 160 mg/5mL E 20171231 53807-197_c23d22ea-c043-4f02-a021-2764e71b4753 53807-197 HUMAN OTC DRUG Ri Mucil Psyllium Dietary Fiber Supplement GRANULE, FOR SOLUTION ORAL 19990316 OTC MONOGRAPH NOT FINAL part334 Rij Pharmaceutical Corporation PSYLLIUM HUSK 3.4 g/100g E 20171231 53807-200_cfa39abb-2405-4264-9868-a7d514653394 53807-200 HUMAN OTC DRUG Fiber Therapy Orange Flavor Psyllium Dietary Fiber Supplement GRANULE, FOR SOLUTION ORAL 19990316 OTC MONOGRAPH NOT FINAL part334 Rij Pharmaceutical Corporation PSYLLIUM HUSK 3.4 g/100g E 20171231 53807-204_bba30427-4867-42ca-aee9-f7af13a2466e 53807-204 HUMAN OTC DRUG Diphenhydramine Oral Liquid Diphenhydramine Hydrochloride LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 53807-216_be1e524a-2cdf-48ce-a64f-6bb91d9c52e9 53807-216 HUMAN OTC DRUG Docusate Sodium Liquid Docusate sodium LIQUID ORAL 19990316 OTC MONOGRAPH NOT FINAL part334 Rij Pharmaceutical Corporation DOCUSATE SODIUM 10 mg/mL E 20171231 53807-220_ce46265c-889e-49a8-8c43-e4637be22f56 53807-220 HUMAN OTC DRUG Infants Pain Reliever Acetaminophen SUSPENSION ORAL 19990316 OTC MONOGRAPH NOT FINAL part343 Rij Pharmaceutical Corporation ACETAMINOPHEN 160 mg/1.6mL E 20171231 53807-401_d7117f12-f07b-4747-ba68-e8d25a5a7135 53807-401 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide LIQUID ORAL 19990316 OTC MONOGRAPH NOT FINAL part334 Rij Pharmaceutical Corporation MAGNESIUM HYDROXIDE 400 mg/5mL E 20171231 53807-405_b7d29705-d741-4d24-ab70-96e09fe86b1c 53807-405 HUMAN OTC DRUG antacid cherry flavored Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL E 20171231 53807-406_d4e8cc66-bd91-4da4-89cd-a416880555ac 53807-406 HUMAN OTC DRUG antacid mint flavored Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL E 20171231 53807-408_d3bd6cbb-ef64-4a6b-ada0-b7fbd1a021c7 53807-408 HUMAN OTC DRUG Ritussin Expectorant GUAIFENESIN LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation GUAIFENESIN 100 mg/5mL E 20171231 53807-409_ca57d666-22b3-4ead-8730-707acc8092ee 53807-409 HUMAN OTC DRUG Ritussin DM DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 53807-422_fd309981-d85e-4c1e-b20b-6ea264550f68 53807-422 HUMAN OTC DRUG Childrens Uniphed Nasal Decongestant Pseudoephedrine hydrochloride LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg/5mL E 20171231 53807-502_ca1e85d9-5ad4-418b-986d-221723d60378 53807-502 HUMAN OTC DRUG RI MOX Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL E 20171231 53807-503_e7b503a9-3037-49f7-b32d-696425d30d99 53807-503 HUMAN OTC DRUG Kao-Bis Bismuth Subsalicylate LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part335 Rij Pharmaceutical Corporation BISMUTH SUBSALICYLATE 262 mg/15mL E 20171231 53807-515_f0b1a13f-64b2-470d-ad12-f22e0bac38d0 53807-515 HUMAN OTC DRUG Ka Pec Bismuth Subsalicylate LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part335 Rij Pharmaceutical Corporation BISMUTH SUBSALICYLATE 262 mg/15mL E 20171231 53807-518_e9b9a189-d9e3-42e3-b41c-846a94ebeb37 53807-518 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 19990316 OTC MONOGRAPH NOT FINAL part343 Rij Pharmaceutical Corporation ACETAMINOPHEN 160 mg/5mL E 20171231 53807-520_a7cc2c34-ff19-4d39-8860-de3b40ace25f 53807-520 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 19990316 OTC MONOGRAPH NOT FINAL part343 Rij Pharmaceutical Corporation ACETAMINOPHEN 160 mg/5mL E 20171231 53807-521_ecea4929-cbe1-4927-bd81-51e32c9807fc 53807-521 HUMAN OTC DRUG Nite Time Cold Medicine Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/15mL; mg/15mL; mg/15mL E 20171231 53807-522_d10f79fe-b9d0-45cd-819d-7b7ab9e403cf 53807-522 HUMAN OTC DRUG Nite Time Cold Medicine Cherry Flavor Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/15mL; mg/15mL; mg/15mL E 20171231 53807-523_0d516b93-f976-4cc3-9f2e-fad6f94bb125 53807-523 HUMAN OTC DRUG Infants GAS DROPS Simethicone SUSPENSION/ DROPS ORAL 19960316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation DIMETHICONE 20 mg/.3mL E 20171231 53807-529_a982e3c8-8673-4b60-b603-1c0c88bd8e99 53807-529 HUMAN OTC DRUG Brom Tapp brompheniramine maleate, phenylephrine HCl LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL E 20171231 53807-530_c5809052-3069-4342-8c97-22e9e09ac7a9 53807-530 HUMAN OTC DRUG Brom Tapp DM brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL E 20171231 53807-531_a8e506ed-dcc8-44e5-afba-067fe7124f6d 53807-531 HUMAN OTC DRUG Cough Formula Cough and Cold dextromethorphan hbr, guaifenesin, phenylephrine hcl LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part341 Rij Pharmaceutical Corporation DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 53807-538_b0c7a17c-3c1c-40d5-98c7-bf234f77709b 53807-538 HUMAN OTC DRUG Antacid and Antigas Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 19990316 OTC MONOGRAPH FINAL part332 Rij Pharmaceutical Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL E 20171231 53807-556_ba6edb97-c969-42d6-b7ab-cc04eeafbbfd 53807-556 HUMAN OTC DRUG Senna Sennosides A and B SYRUP ORAL 20161108 OTC MONOGRAPH NOT FINAL part334 Rij Pharmaceutical Corporation SENNOSIDES A AND B 8.8 mg/5mL N 20181231 53808-0104_68a98d1d-a74f-4d43-9ebe-c50795b3975b 53808-0104 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20090701 ANDA ANDA076071 State of Florida DOH Central Pharmacy LISINOPRIL 10 mg/1 E 20171231 53808-0162_d5cbfe16-755c-412f-9926-caa2f8222e07 53808-0162 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET ORAL 20090620 NDA NDA070976 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53808-0165_dc9c799a-3c8e-4860-891c-fc3fff243a85 53808-0165 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20080501 ANDA ANDA077002 DEPT HEALTH CENTRAL PHARMACY DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 53808-0200_24efe210-73f3-446c-a8d3-88baa1508702 53808-0200 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20090701 ANDA ANDA077955 State of Florida DOH Central Pharmacy AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 53808-0203_9798152d-b3b5-4fc6-985e-10b59177464b 53808-0203 HUMAN PRESCRIPTION DRUG ACCOLATE Zafirlukast TABLET, FILM COATED ORAL 20090701 NDA NDA020547 State of Florida DOH Central Pharmacy ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 53808-0205_bac1e923-6161-462a-bfd3-37cfb34a7313 53808-0205 HUMAN PRESCRIPTION DRUG Asacol mesalamine TABLET, DELAYED RELEASE ORAL 20090701 NDA NDA019651 State of Florida DOH Central Pharmacy MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 53808-0207_81b9fca7-f47d-4293-87ae-856c4b1c5f96 53808-0207 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA076900 State of Florida DOH Central Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 53808-0208_20fe8a0b-95db-4d4c-80e2-54a9126ab845 53808-0208 HUMAN PRESCRIPTION DRUG Atripla efavirenz, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20090701 NDA NDA021937 DOH CENTRAL PHARMACY EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600; 200; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 53808-0210_d977e7ce-4bbb-42ba-aad5-ac46ef656206 53808-0210 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20090701 ANDA ANDA072265 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 53808-0211_6652f325-aa55-42d6-98a9-8d3684bc3a7f 53808-0211 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20090701 ANDA ANDA089059 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 53808-0213_bd3c717d-992b-420d-afd5-fa67e62964f2 53808-0213 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA075310 State of Florida DOH Central Pharmacy BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 53808-0214_6d43cb24-1cea-446c-a8c6-4adb5796b799 53808-0214 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA075491 State of Florida DOH Central Pharmacy BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 53808-0215_11787967-2085-466f-b251-c24b58f130c8 53808-0215 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA075584 State of Florida DOH Central Pharmacy BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 53808-0216_67899f20-3cd2-4af1-ac3c-c46fced8a2f3 53808-0216 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20090701 ANDA ANDA077728 State of Florida DOH Central Pharmacy CALCIUM ACETATE 667 mg/1 Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] E 20171231 53808-0217_769ec7f0-f2c0-4a40-89bb-c7c7776a1a37 53808-0217 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090701 ANDA ANDA074505 DOH CENTRAL PHARMACY CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53808-0218_1339e658-4db8-40e9-a68e-c43de4857968 53808-0218 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20090701 ANDA ANDA078251 State of Florida DOH Central Pharmacy CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 53808-0219_1339e658-4db8-40e9-a68e-c43de4857968 53808-0219 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20090701 ANDA ANDA078251 State of Florida DOH Central Pharmacy CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 53808-0220_44a37407-7509-45ef-972b-b48c234f2863 53808-0220 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090701 ANDA ANDA077614 State of Florida DOH Central Pharmacy CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 53808-0221_1339e658-4db8-40e9-a68e-c43de4857968 53808-0221 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20090701 ANDA ANDA078251 State of Florida DOH Central Pharmacy CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 53808-0222_ccd16e47-b47c-48e5-8281-f679ae506ddc 53808-0222 HUMAN PRESCRIPTION DRUG Cephalexin CEPHALEXIN CAPSULE ORAL 20090701 ANDA ANDA062702 State of Florida DOH Central Pharmacy CEPHALEXIN 500 mg/1 E 20171231 53808-0223_a6b62110-f357-430a-b8ca-aa0dc66aa66f 53808-0223 HUMAN PRESCRIPTION DRUG Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride TABLET ORAL 20090701 ANDA ANDA076089 State of Florida DOH Central Pharmacy CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 53808-0225_27718392-5a3a-4eae-819b-e0f4a2028d37 53808-0225 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20090701 ANDA ANDA078216 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0226_fdee2c6d-0343-43e4-9031-aea90341e5ef 53808-0226 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20090701 ANDA ANDA077042 State of Florida DOH Central Pharmacy CITALOPRAM 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0227_6ab2f82f-8e66-446d-83f0-73713b99667e 53808-0227 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20090701 ANDA ANDA077031 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0228_462a1a82-eaa9-4676-9569-925f18fd30d2 53808-0228 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090701 ANDA ANDA070317 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53808-0229_cca81cb7-cf0c-4416-b95c-897f1ed751e3 53808-0229 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20090701 ANDA ANDA070925 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53808-0230_462a1a82-eaa9-4676-9569-925f18fd30d2 53808-0230 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090701 ANDA ANDA070317 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53808-0231_d7cb62b2-8bcc-4eab-a08c-a9d78be0ed06 53808-0231 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA070976 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53808-0233_6f87d871-e2de-4445-9ecf-d00bfeb0afec 53808-0233 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride DICYCLOMINE HYDROCHLORIDE CAPSULE ORAL 20090701 ANDA ANDA085082 State of Florida DOH Central Pharmacy DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 53808-0234_6f87d871-e2de-4445-9ecf-d00bfeb0afec 53808-0234 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride DICYCLOMINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA085223 State of Florida DOH Central Pharmacy DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 53808-0236_1dc18acf-c100-4c94-a5e5-1ba3e9218bab 53808-0236 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE PELLETS ORAL 20090701 ANDA ANDA077167 State of Florida DOH Central Pharmacy DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 53808-0237_e640eb6e-424c-4960-a4a0-347bed1fba47 53808-0237 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20090701 ANDA ANDA077002 State of Florida DOH Central Pharmacy DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 53808-0238_bface779-bc4b-4c83-9760-690b25c0b6db 53808-0238 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20090701 ANDA ANDA080738 State of Florida DOH Central Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 53808-0239_92838745-01df-458d-ab9b-0305a682fdc1 53808-0239 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20090701 ANDA ANDA062396 State of Florida DOH Central Pharmacy DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 53808-0240_62a8fff7-b70e-45a1-a284-5c6315fcbdd9 53808-0240 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20090701 ANDA ANDA062500 State of Florida DOH Central Pharmacy DOXYCYCLINE HYCLATE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 53808-0242_23f7f4ad-800c-4d98-a604-3c45b2842841 53808-0242 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090701 ANDA ANDA075483 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 53808-0243_23f7f4ad-800c-4d98-a604-3c45b2842841 53808-0243 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090701 ANDA ANDA075483 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 53808-0244_23f7f4ad-800c-4d98-a604-3c45b2842841 53808-0244 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090701 ANDA ANDA075483 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 53808-0245_4e2ee289-a8d8-4d02-ac27-0a2a2d0bbe22 53808-0245 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20090701 NDA NDA020564 State of Florida DOH Central Pharmacy LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0246_4e2ee289-a8d8-4d02-ac27-0a2a2d0bbe22 53808-0246 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20090701 NDA NDA020564 State of Florida DOH Central Pharmacy LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0247_4589f1cd-5570-48bb-a94b-499faa06d4a1 53808-0247 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20090701 ANDA ANDA089804 State of Florida DOH Central Pharmacy FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53808-0250_3d205ce1-db62-4a8b-931b-ec5d43dceacb 53808-0250 HUMAN PRESCRIPTION DRUG Folic Acid FOLIC ACID TABLET ORAL 20090701 ANDA ANDA080600 State of Florida DOH Central Pharmacy FOLIC ACID 1 mg/1 E 20171231 53808-0251_359f0124-ff71-4682-99dd-3282afdee8c1 53808-0251 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20090701 ANDA ANDA074256 State of Florida DOH Central Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 53808-0252_782f8abe-1590-4c9a-a64c-e7dd7a73bf24 53808-0252 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20090701 NDA NDA020825 State of Florida DOH Central Pharmacy ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 53808-0253_782f8abe-1590-4c9a-a64c-e7dd7a73bf24 53808-0253 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20090701 NDA NDA020825 State of Florida DOH Central Pharmacy ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] E 20171231 53808-0254_782f8abe-1590-4c9a-a64c-e7dd7a73bf24 53808-0254 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20090701 NDA NDA020825 State of Florida DOH Central Pharmacy ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] E 20171231 53808-0255_782f8abe-1590-4c9a-a64c-e7dd7a73bf24 53808-0255 HUMAN PRESCRIPTION DRUG Geodon ziprasidone hydrochloride CAPSULE ORAL 20090701 NDA NDA020825 State of Florida DOH Central Pharmacy ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] E 20171231 53808-0257_f4c42007-6416-4a89-a0de-5f5fd382d511 53808-0257 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20090701 ANDA ANDA074497 State of Florida DOH Central Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 53808-0258_120da67b-a619-4a3e-a70a-b7f8bab7a80e 53808-0258 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20090701 ANDA ANDA074305 State of Florida DOH Central Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 53808-0259_120da67b-a619-4a3e-a70a-b7f8bab7a80e 53808-0259 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20090701 ANDA ANDA074305 State of Florida DOH Central Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 53808-0260_f4c42007-6416-4a89-a0de-5f5fd382d511 53808-0260 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20090701 ANDA ANDA074497 State of Florida DOH Central Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 53808-0261_95cbdf47-932d-40d3-bc1d-e055170711d6 53808-0261 HUMAN PRESCRIPTION DRUG Gris-PEG GRISEOFULVIN TABLET, FILM COATED ORAL 20090701 NDA NDA050475 State of Florida DOH Central Pharmacy GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] E 20171231 53808-0263_ff1989ff-b72f-4071-b121-ed099cef0a9f 53808-0263 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20090701 ANDA ANDA071209 State of Florida DOH Central Pharmacy HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 53808-0264_3cf84e3a-2a50-4d72-9461-ffd9c78bd244 53808-0264 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20090701 ANDA ANDA070278 State of Florida DOH Central Pharmacy HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] E 20171231 53808-0265_4b0829da-c42f-4850-ac45-ac363e773ff7 53808-0265 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20090701 ANDA ANDA078164 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 53808-0266_7c9d486e-b2ef-4dc7-97cf-1a545471f73f 53808-0266 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20090701 ANDA ANDA084878 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 53808-0271_b4a23505-70ad-4e79-9923-a37ce160b072 53808-0271 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20090701 ANDA ANDA078558 State of Florida DOH Central Pharmacy IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53808-0272_42aee221-dc31-493c-b420-18cdb1546968 53808-0272 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090701 ANDA ANDA071334 State of Florida DOH Central Pharmacy IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 53808-0273_42aee221-dc31-493c-b420-18cdb1546968 53808-0273 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090701 ANDA ANDA071335 State of Florida DOH Central Pharmacy IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 53808-0274_be372192-7929-425c-9c3a-396b75f6882f 53808-0274 HUMAN PRESCRIPTION DRUG Isosorbide ISOSORBIDE DINITRATE TABLET ORAL 20090701 ANDA ANDA086066 State of Florida DOH Central Pharmacy ISOSORBIDE DINITRATE 10 mg/1 E 20171231 53808-0275_be372192-7929-425c-9c3a-396b75f6882f 53808-0275 HUMAN PRESCRIPTION DRUG Isosorbide ISOSORBIDE DINITRATE TABLET ORAL 20090701 ANDA ANDA086066 State of Florida DOH Central Pharmacy ISOSORBIDE DINITRATE 20 mg/1 E 20171231 53808-0276_b4e1380c-7e64-4455-a71f-080954122c0e 53808-0276 HUMAN PRESCRIPTION DRUG Kaletra lopinavir and ritonavir TABLET, FILM COATED ORAL 20090701 NDA NDA021906 DOH CENTRAL PHARMACY LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 53808-0277_7eefbe68-0324-4b28-b777-3922e62c7471 53808-0277 HUMAN PRESCRIPTION DRUG K-TAB POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 NDA NDA018279 State of Florida DOH Central Pharmacy POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 53808-0278_6a46fb5b-6243-4901-8152-dc651643b684 53808-0278 HUMAN PRESCRIPTION DRUG Klor-Con Extended-release Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20090701 NDA NDA019123 State of Florida DOH Central Pharmacy POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 53808-0279_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0279 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 53808-0280_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0280 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 53808-0281_cece4944-71c2-4ded-a002-3475b1cae6a2 53808-0281 HUMAN PRESCRIPTION DRUG LEXIVA fosamprenavir calcium TABLET, FILM COATED ORAL 20090701 NDA NDA021548 State of Florida DOH Central Pharmacy FOSAMPRENAVIR CALCIUM 700 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],P-Glycoprotein Inducers [MoA] E 20171231 53808-0302_377ae7e3-f630-4ebb-b85c-312b614c8631 53808-0302 HUMAN PRESCRIPTION DRUG SULINDAC sulindac TABLET ORAL 20090701 ANDA ANDA072051 State of Florida DOH Central Pharmacy SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53808-0303_3f0ef949-f3ea-4ff8-877a-c412ae2e175e 53808-0303 HUMAN PRESCRIPTION DRUG Sulindac SULINDAC TABLET ORAL 20090701 ANDA ANDA073262 State of Florida DOH Central Pharmacy SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 53808-0305_f119023a-c0b0-4201-ad2a-3ac5ef3e2fbc 53808-0305 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075614 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 53808-0306_344b0ac9-7bea-4167-8b70-3a000fb50823 53808-0306 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075498 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 53808-0307_9e1fb9de-7a5e-4878-af41-2efe32d8f9ad 53808-0307 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 53808-0308_344b0ac9-7bea-4167-8b70-3a000fb50823 53808-0308 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075498 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 53808-0309_9e1fb9de-7a5e-4878-af41-2efe32d8f9ad 53808-0309 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 53808-0310_2af82929-450b-40bc-82ba-f365b94a5521 53808-0310 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20090701 ANDA ANDA076228 State of Florida DOH Central Pharmacy RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 53808-0311_9e1fb9de-7a5e-4878-af41-2efe32d8f9ad 53808-0311 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 53808-0312_32eaf085-4c88-4aec-b763-9cfcc966ff5f 53808-0312 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate TERBUTALINE SULFATE TABLET ORAL 20090701 ANDA ANDA077152 State of Florida DOH Central Pharmacy TERBUTALINE SULFATE 2.5 mg/1 E 20171231 53808-0315_adfc71f3-28e7-4f69-95bd-2f87e3c0243d 53808-0315 HUMAN PRESCRIPTION DRUG Theophylline (Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA089808 State of Florida DOH Central Pharmacy THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 53808-0316_adfc71f3-28e7-4f69-95bd-2f87e3c0243d 53808-0316 HUMAN PRESCRIPTION DRUG Theophylline (Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA089763 State of Florida DOH Central Pharmacy THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 53808-0324_ec8d1d34-d828-493d-b145-da4f4e2725ea 53808-0324 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 NDA NDA019152 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 53808-0329_a35648a5-edad-466e-97cf-fc1ce7993bce 53808-0329 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA073568 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 53808-0334_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0334 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 53808-0335_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0335 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 53808-0338_563b3f57-28df-47cb-b929-86783f5414e1 53808-0338 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20090701 ANDA ANDA040750 State of Florida DOH Central Pharmacy SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 53808-0340_3708f86b-3fcb-49a2-9d6e-92a7b123ab04 53808-0340 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20090701 ANDA ANDA077262 State of Florida DOH Central Pharmacy AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-0341_9a69d84c-47c1-4d64-a51b-4f726d472cf8 53808-0341 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20090701 ANDA ANDA065101 State of Florida DOH Central Pharmacy AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 53808-0344_81b9fca7-f47d-4293-87ae-856c4b1c5f96 53808-0344 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA076900 State of Florida DOH Central Pharmacy ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 53808-0345_b9f26cb9-7155-4c81-9b2e-7f1d72bddc46 53808-0345 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA077877 State of Florida DOH Central Pharmacy ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0346_b9f26cb9-7155-4c81-9b2e-7f1d72bddc46 53808-0346 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA077877 State of Florida DOH Central Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0347_b5efba99-807d-4778-b769-e95c960a9e86 53808-0347 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA075491 State of Florida DOH Central Pharmacy BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 53808-0348_e4a7f215-ee57-4a42-9cc8-8656a08f45ea 53808-0348 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090701 ANDA ANDA074505 State of Florida DOH Central Pharmacy CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 53808-0349_3a986ef3-1be4-4686-9679-acef5ca5ca21 53808-0349 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA076794 State of Florida DOH Central Pharmacy CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 53808-0350_27718392-5a3a-4eae-819b-e0f4a2028d37 53808-0350 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20090701 ANDA ANDA078216 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0351_f086cca5-5d13-4a7f-9713-c6d4fcf43665 53808-0351 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE TABLET, FILM COATED ORAL 20090701 ANDA ANDA077046 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0352_d7cb62b2-8bcc-4eab-a08c-a9d78be0ed06 53808-0352 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA070904 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53808-0353_1dc18acf-c100-4c94-a5e5-1ba3e9218bab 53808-0353 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE PELLETS ORAL 20090701 ANDA ANDA077167 State of Florida DOH Central Pharmacy DIDANOSINE 400 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 53808-0354_54d59552-7316-4ea7-b0b3-4e9e761ea4cd 53808-0354 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20090701 ANDA ANDA007628 State of Florida DOH Central Pharmacy DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 53808-0355_e640eb6e-424c-4960-a4a0-347bed1fba47 53808-0355 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20090701 ANDA ANDA077002 State of Florida DOH Central Pharmacy DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 53808-0356_21f86570-ae06-4196-a09d-15bb669b9224 53808-0356 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20090701 ANDA ANDA090062 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 53808-0357_02550fd6-1cc7-438a-8f3d-d2c4b2da8000 53808-0357 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20090701 ANDA ANDA078790 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 53808-0358_02550fd6-1cc7-438a-8f3d-d2c4b2da8000 53808-0358 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20090701 ANDA ANDA078790 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 53808-0359_769ec7f0-f2c0-4a40-89bb-c7c7776a1a37 53808-0359 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090701 ANDA ANDA074505 DOH CENTRAL PHARMACY CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53808-0361_7a5592af-57c2-48b1-b7e4-5c15ed9cd14f 53808-0361 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20090701 ANDA ANDA075536 State of Florida DOH Central Pharmacy DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 53808-0362_7a5592af-57c2-48b1-b7e4-5c15ed9cd14f 53808-0362 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20090701 ANDA ANDA075536 State of Florida DOH Central Pharmacy DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 53808-0364_4f9270e1-42ae-48f4-93dc-70dc5dd56eef 53808-0364 HUMAN PRESCRIPTION DRUG Doxazosin DOXAZOSIN MESYLATE TABLET ORAL 20090701 ANDA ANDA075580 State of Florida DOH Central Pharmacy DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 53808-0366_bf71addd-a989-4420-9741-4e7a404725e7 53808-0366 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075049 State of Florida DOH Central Pharmacy FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0367_148f9cb8-e3b7-41e8-ae24-c1468380fc12 53808-0367 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE TABLET ORAL 20090701 NDA NDA018487 State of Florida DOH Central Pharmacy FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 53808-0368_2c7f8247-ab92-4487-90e5-458e72b791ce 53808-0368 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20090701 ANDA ANDA075034 State of Florida DOH Central Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 53808-0369_d50f8011-19de-4fd5-8d7b-61d8618c77d7 53808-0369 HUMAN PRESCRIPTION DRUG Glipizide GLIPIZIDE TABLET ORAL 20090701 ANDA ANDA074223 State of Florida DOH Central Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 53808-0372_3cf84e3a-2a50-4d72-9461-ffd9c78bd244 53808-0372 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20090701 ANDA ANDA070278 State of Florida DOH Central Pharmacy HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] N 20181231 53808-0373_4a569fe7-e80a-4e04-8b9c-52eb65ed4b96 53808-0373 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20090701 ANDA ANDA088496 State of Florida DOH Central Pharmacy HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 53808-0374_4a569fe7-e80a-4e04-8b9c-52eb65ed4b96 53808-0374 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20090701 ANDA ANDA088487 State of Florida DOH Central Pharmacy HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 53808-0375_6a46fb5b-6243-4901-8152-dc651643b684 53808-0375 HUMAN PRESCRIPTION DRUG Klor-Con Extended-release Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20090701 NDA NDA019123 State of Florida DOH Central Pharmacy POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 53808-0376_30b8361b-39f0-4763-a149-9b2eb7d169f1 53808-0376 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20090701 ANDA ANDA076919 State of Florida DOH Central Pharmacy LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 53808-0377_80210249-70fb-4d75-be2b-8c490f5d26fe 53808-0377 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090701 ANDA ANDA078234 State of Florida DOH Central Pharmacy LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 53808-0379_133790e1-93d7-46cc-9385-fbf7ad7ded38 53808-0379 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20090701 ANDA ANDA075752 State of Florida DOH Central Pharmacy LISINOPRIL 5 mg/1 E 20171231 53808-0380_00973f5a-1447-4002-a86a-e2b61fad3678 53808-0380 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA087128 State of Florida DOH Central Pharmacy MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 53808-0381_45abd94e-142e-4da8-ad7b-566a18395935 53808-0381 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20090701 ANDA ANDA078170 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 53808-0382_f59d2f6d-b2ff-418e-92fc-e00ccd7d63ff 53808-0382 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA076704 State of Florida DOH Central Pharmacy METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 53808-0384_1cc2185f-3508-416f-adef-71235f629434 53808-0384 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20090701 ANDA ANDA076122 State of Florida DOH Central Pharmacy MIRTAZAPINE 15 mg/1 E 20171231 53808-0386_443d6c91-7f02-4950-940f-c5192ed6f519 53808-0386 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090701 ANDA ANDA078250 State of Florida DOH Central Pharmacy NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 53808-0387_06bf9e41-9ba5-477f-9126-fa1aa23eee32 53808-0387 HUMAN PRESCRIPTION DRUG Nifedipine NIFEDIPINE TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA077899 State of Florida DOH Central Pharmacy NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-0388_668ca968-ba6e-4477-9fa1-76b42377c8dc 53808-0388 HUMAN PRESCRIPTION DRUG Nifediac CC Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA075269 State of Florida DOH Central Pharmacy NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-0389_06bf9e41-9ba5-477f-9126-fa1aa23eee32 53808-0389 HUMAN PRESCRIPTION DRUG Nifedipine NIFEDIPINE TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA077899 State of Florida DOH Central Pharmacy NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-0393_2f9e9ab0-e535-46e9-9f50-20bb433e38f9 53808-0393 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA078902 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0394_2f9e9ab0-e535-46e9-9f50-20bb433e38f9 53808-0394 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA078902 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0395_533b9303-6097-4eee-a802-d7623461b82a 53808-0395 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, SUGAR COATED ORAL 20090701 ANDA ANDA040226 State of Florida DOH Central Pharmacy PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 53808-0398_9db1257e-0491-4c8d-85d6-37fa1f425cbd 53808-0398 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20090701 ANDA ANDA077987 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-0399_9186d7c5-980c-49ad-8185-e9e13df26df4 53808-0399 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20090701 ANDA ANDA083677 State of Florida DOH Central Pharmacy PREDNISONE 20 mg/1 E 20171231 53808-0400_909faecb-fb9e-48a7-a66b-0ae151d1e9a0 53808-0400 HUMAN PRESCRIPTION DRUG Glipizide GLIPIZIDE TABLET ORAL 20090701 ANDA ANDA075795 State of Florida DOH Central Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 53808-0401_9a06be01-be79-4aec-869b-b76a2ce44f8a 53808-0401 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA076467 State of Florida DOH Central Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 53808-0408_5edec495-4de9-4313-a841-c22309acadfe 53808-0408 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20090701 NDA NDA020329 State of Florida DOH Central Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 53808-0409_5edec495-4de9-4313-a841-c22309acadfe 53808-0409 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20090701 NDA NDA020329 State of Florida DOH Central Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 53808-0411_15601703-7442-48f3-89f4-44fef66b7514 53808-0411 HUMAN PRESCRIPTION DRUG Xeloda capecitabine TABLET, FILM COATED ORAL 20090701 NDA NDA020896 State of Florida DOH Central Pharmacy CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 53808-0414_ff1989ff-b72f-4071-b121-ed099cef0a9f 53808-0414 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20090701 ANDA ANDA071208 State of Florida DOH Central Pharmacy HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] N 20181231 53808-0419_6a12a175-287e-48ae-bd9b-b267e7e28567 53808-0419 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20090701 ANDA ANDA075907 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 53808-0422_6a12a175-287e-48ae-bd9b-b267e7e28567 53808-0422 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide TABLET ORAL 20090701 ANDA ANDA075907 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 53808-0426_7896d94e-463d-41ff-8ac0-0680c8c857df 53808-0426 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20090701 ANDA ANDA040156 State of Florida DOH Central Pharmacy HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 53808-0429_7896d94e-463d-41ff-8ac0-0680c8c857df 53808-0429 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20090701 ANDA ANDA040156 State of Florida DOH Central Pharmacy HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 53808-0431_4a569fe7-e80a-4e04-8b9c-52eb65ed4b96 53808-0431 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20090701 ANDA ANDA088488 State of Florida DOH Central Pharmacy HYDROXYZINE PAMOATE 100 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 53808-0435_b4a23505-70ad-4e79-9923-a37ce160b072 53808-0435 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20090701 ANDA ANDA078558 State of Florida DOH Central Pharmacy IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 53808-0436_42aee221-dc31-493c-b420-18cdb1546968 53808-0436 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090701 ANDA ANDA071335 State of Florida DOH Central Pharmacy IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 53808-0446_7301eec3-0d3c-4d44-b517-e22eb4791f13 53808-0446 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090701 NDA NDA021210 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 53808-0447_7301eec3-0d3c-4d44-b517-e22eb4791f13 53808-0447 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090701 NDA NDA021210 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 53808-0449_7301eec3-0d3c-4d44-b517-e22eb4791f13 53808-0449 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090701 NDA NDA021210 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 53808-0451_be846696-b798-4124-a1ae-9bbe4c8588ff 53808-0451 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090701 ANDA ANDA077321 State of Florida DOH Central Pharmacy LISINOPRIL; HYDROCHLOROTHIAZIDE 5; 12.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 53808-0452_cbd971fd-9be2-4407-be07-63072d218b76 53808-0452 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090701 ANDA ANDA078402 State of Florida DOH Central Pharmacy LISINOPRIL; HYDROCHLOROTHIAZIDE 5; 12.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 53808-0453_be846696-b798-4124-a1ae-9bbe4c8588ff 53808-0453 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090701 ANDA ANDA077321 State of Florida DOH Central Pharmacy LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 53808-0457_f9604c52-0f89-43dc-8be9-e478db8f029e 53808-0457 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20090701 ANDA ANDA076301 State of Florida DOH Central Pharmacy LORATADINE 10 mg/1 N 20181231 53808-0459_34fcbbab-fafb-422c-9389-141a52c8b045 53808-0459 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077095 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 53808-0474_d89858c2-db7b-4496-b730-98d4c5864aa5 53808-0474 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20090701 ANDA ANDA070027 State of Florida DOH Central Pharmacy METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 53808-0478_cc4f0754-489c-41b9-b871-1c9a79779503 53808-0478 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20090701 ANDA ANDA071973 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0482_3d0fdbe3-37f0-4f8c-a132-76c2fd155c55 53808-0482 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090701 ANDA ANDA077666 State of Florida DOH Central Pharmacy MIRTAZAPINE 15 mg/1 E 20171231 53808-0483_3d0fdbe3-37f0-4f8c-a132-76c2fd155c55 53808-0483 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090701 ANDA ANDA077666 State of Florida DOH Central Pharmacy MIRTAZAPINE 30 mg/1 E 20171231 53808-0484_3d0fdbe3-37f0-4f8c-a132-76c2fd155c55 53808-0484 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090701 ANDA ANDA077666 State of Florida DOH Central Pharmacy MIRTAZAPINE 45 mg/1 E 20171231 53808-0496_cb95c93f-4e5e-4ae7-a755-b24d2d6e6474 53808-0496 HUMAN PRESCRIPTION DRUG nifedipine NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 NDA NDA019684 State of Florida DOH Central Pharmacy NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-0500_eaac3a82-2f22-47b4-b3a2-41aab8d9c4af 53808-0500 HUMAN PRESCRIPTION DRUG Nifediac CC Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA076070 State of Florida DOH Central Pharmacy NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-0516_23daa058-b3fc-4518-89e4-7da98cd2f0ec 53808-0516 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA075191 State of Florida DOH Central Pharmacy PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 53808-0536_4bb744b3-53ca-41c6-90ab-fe35cc1bc8bc 53808-0536 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20090701 ANDA ANDA076341 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-0538_4bb744b3-53ca-41c6-90ab-fe35cc1bc8bc 53808-0538 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20090701 ANDA ANDA076341 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-0540_9186d7c5-980c-49ad-8185-e9e13df26df4 53808-0540 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20090701 ANDA ANDA088832 State of Florida DOH Central Pharmacy PREDNISONE 5 mg/1 E 20171231 53808-0542_db44ab07-40f8-4c1d-ab88-cfe4b0476962 53808-0542 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20090701 ANDA ANDA040256 State of Florida DOH Central Pharmacy PREDNISONE 10 mg/1 E 20171231 53808-0543_db44ab07-40f8-4c1d-ab88-cfe4b0476962 53808-0543 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20090701 ANDA ANDA040392 State of Florida DOH Central Pharmacy PREDNISONE 20 mg/1 E 20171231 53808-0545_b5cb6a82-f1ae-422a-909c-b75e214bbc40 53808-0545 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA040596 State of Florida DOH Central Pharmacy PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 53808-0546_9c6f2837-3027-4a9e-9430-876dd4ccecc1 53808-0546 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA040712 State of Florida DOH Central Pharmacy PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 53808-0547_951caa1a-b448-4864-abdc-4c47f87ef3cf 53808-0547 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20090701 ANDA ANDA078955 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0551_951caa1a-b448-4864-abdc-4c47f87ef3cf 53808-0551 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20090701 ANDA ANDA078955 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0559_93662de7-bfe4-4237-aa23-7370a2515cb1 53808-0559 HUMAN PRESCRIPTION DRUG Rifampin RIFAMPIN CAPSULE, COATED ORAL 20090701 ANDA ANDA065028 State of Florida DOH Central Pharmacy RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 53808-0560_db44ab07-40f8-4c1d-ab88-cfe4b0476962 53808-0560 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20090701 ANDA ANDA040256 State of Florida DOH Central Pharmacy PREDNISONE 5 mg/1 E 20171231 53808-0565_f5d90028-7dbe-41ad-8d7e-70eccdce8807 53808-0565 HUMAN PRESCRIPTION DRUG Risperidone RISPERIDONE TABLET, FILM COATED ORAL 20090701 ANDA ANDA078871 DOH CENTRAL PHARMACY RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 53808-0574_df05a7ce-0e25-4c7c-a69d-1e1b9e13de61 53808-0574 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 State of Florida DOH Central Pharmacy RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 53808-0577_29dcedcd-efba-436a-8542-99faff58875f 53808-0577 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20090701 NDA NDA021688 State of Florida DOH Central Pharmacy CINACALCET HYDROCHLORIDE 30 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] E 20171231 53808-0578_29dcedcd-efba-436a-8542-99faff58875f 53808-0578 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20090701 NDA NDA021688 State of Florida DOH Central Pharmacy CINACALCET HYDROCHLORIDE 60 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] E 20171231 53808-0579_f7280544-b20f-450a-a4f3-24c288ed2012 53808-0579 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077397 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0581_f7280544-b20f-450a-a4f3-24c288ed2012 53808-0581 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077397 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0582_d520f657-e5b4-4910-add5-978daa79b0d5 53808-0582 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 NDA NDA019839 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0586_56627a5a-696b-41cd-9d0c-8d34b074ba6a 53808-0586 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077670 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0587_f7280544-b20f-450a-a4f3-24c288ed2012 53808-0587 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA077397 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0592_563b3f57-28df-47cb-b929-86783f5414e1 53808-0592 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20090701 ANDA ANDA040750 State of Florida DOH Central Pharmacy SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 53808-0593_ecd35838-b551-4cc1-8cb2-2dc3335c61d4 53808-0593 HUMAN PRESCRIPTION DRUG Sucralfate SUCRALFATE TABLET ORAL 20090701 NDA NDA018333 State of Florida DOH Central Pharmacy SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] E 20171231 53808-0594_995c744e-3132-4384-9d05-8976bfd1bc7d 53808-0594 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20090701 ANDA ANDA079069 State of Florida DOH Central Pharmacy STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0595_8a5e45f3-462d-4f86-b06b-4df7ca2da01e 53808-0595 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20090701 ANDA ANDA078957 State of Florida DOH Central Pharmacy STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 53808-0600_4589f1cd-5570-48bb-a94b-499faa06d4a1 53808-0600 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20090701 ANDA ANDA089804 State of Florida DOH Central Pharmacy FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 53808-0601_2f9e9ab0-e535-46e9-9f50-20bb433e38f9 53808-0601 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA078902 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0602_b49a1ada-2942-400e-be4a-18c06cbecad2 53808-0602 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20130101 ANDA ANDA090515 State of Florida DOH Central Pharmacy LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 53808-0603_1339e658-4db8-40e9-a68e-c43de4857968 53808-0603 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20090701 ANDA ANDA078251 State of Florida DOH Central Pharmacy CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 53808-0604_0ea2345f-d110-4f6a-af82-cf862207127c 53808-0604 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20090701 NDA NDA018832 State of Florida DOH Central Pharmacy ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 53808-0605_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0605 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 53808-0606_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0606 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 53808-0607_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0607 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 53808-0608_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0608 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 53808-0609_d88b8407-6321-44b4-bf1e-1f620e643a80 53808-0609 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 20130101 ANDA ANDA075211 State of Florida DOH Central Pharmacy ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 53808-0611_60f294ff-ca82-4023-b929-dac46aca6867 53808-0611 HUMAN PRESCRIPTION DRUG Dicyclomine DICYCLOMINE HYDROCHLORIDE CAPSULE ORAL 20090701 ANDA ANDA040204 State of Florida DOH Central Pharmacy DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 53808-0612_c41bbdff-b9a6-4235-acf7-680e95dd57aa 53808-0612 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090701 ANDA ANDA074984 State of Florida DOH Central Pharmacy DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 53808-0613_93d2b84b-0609-4350-88c9-464b7add33f6 53808-0613 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA077336 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 53808-0614_b1c52027-d48b-4960-beea-9ec1721eccae 53808-0614 HUMAN PRESCRIPTION DRUG Megestrol Acetate MEGESTROL ACETATE TABLET ORAL 20090701 ANDA ANDA074458 State of Florida DOH Central Pharmacy MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 53808-0615_88ea22b4-1004-478a-b914-09dd77dde766 53808-0615 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090701 ANDA ANDA075927 State of Florida DOH Central Pharmacy NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 53808-0616_34db910e-8a16-4cee-a04e-27a363f0c269 53808-0616 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20130101 ANDA ANDA090540 State of Florida DOH Central Pharmacy CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 53808-0617_dd158c6f-db49-4875-a5f2-853947200bf1 53808-0617 HUMAN PRESCRIPTION DRUG Lisinopril LISINOPRIL TABLET ORAL 20090701 ANDA ANDA077622 State of Florida DOH Central Pharmacy LISINOPRIL 20 mg/1 E 20171231 53808-0618_029f6aeb-9a10-4aa1-9c87-bec59bd75bfe 53808-0618 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 20090701 ANDA ANDA075079 State of Florida DOH Central Pharmacy OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 53808-0619_08665e9d-75fe-420f-85a0-f9f89d889fba 53808-0619 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA040788 State of Florida DOH Central Pharmacy HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 53808-0621_f270b06b-e60d-41e3-88bc-9599737f8dba 53808-0621 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130101 ANDA ANDA077127 State of Florida DOH Central Pharmacy NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-0622_8b88451a-13e3-4a26-848d-b6209aa21ddb 53808-0622 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20130101 ANDA ANDA062791 State of Florida DOH Central Pharmacy CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 53808-0623_a995488f-2f37-47fa-9315-d75d407160db 53808-0623 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20130101 ANDA ANDA071250 State of Florida DOH Central Pharmacy METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 53808-0624_76437cab-3ca6-4e54-9c58-803f50404969 53808-0624 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20130101 ANDA ANDA076288 State of Florida DOH Central Pharmacy RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 53808-0625_59ddd062-699a-4baf-942c-0b660cb1b15e 53808-0625 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20130101 ANDA ANDA074550 State of Florida DOH Central Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 53808-0626_bd1688e6-8f0a-4238-bf1a-ecd770bb6496 53808-0626 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20130101 ANDA ANDA089367 State of Florida DOH Central Pharmacy ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 53808-0627_61e9324f-3ef3-45d7-9735-a89a03aeec42 53808-0627 HUMAN PRESCRIPTION DRUG Abacavir Sulfate abacavir sulfate TABLET, FILM COATED ORAL 20130101 ANDA ANDA091294 State of Florida DOH Central Pharmacy ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0628_77fcfab4-3e34-45c9-9048-a3b9c1e9de6b 53808-0628 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20130101 ANDA ANDA075382 State of Florida DOH Central Pharmacy ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 53808-0629_a93001d2-6248-4c2b-b84a-a7458c232f0c 53808-0629 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA040209 State of Florida DOH Central Pharmacy TRIFLUOPERAZINE HYDROCHLORIDE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 53808-0631_b252f4a8-1e2d-48b0-9296-dc9681acdcf7 53808-0631 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20130101 ANDA ANDA070278 State of Florida DOH Central Pharmacy HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] N 20181231 53808-0632_754bd072-a82f-420e-92ea-835e86aa20bf 53808-0632 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA040812 State of Florida DOH Central Pharmacy HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 53808-0633_19e8bb23-2263-46dc-8d64-895aecd5fac0 53808-0633 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 20130101 ANDA ANDA040254 State of Florida DOH Central Pharmacy TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 E 20171231 53808-0634_19e8bb23-2263-46dc-8d64-895aecd5fac0 53808-0634 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 20130101 ANDA ANDA040254 State of Florida DOH Central Pharmacy TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 E 20171231 53808-0635_2d482302-2476-4395-bcc2-53404748c889 53808-0635 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA077655 State of Florida DOH Central Pharmacy VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 53808-0636_a212d98c-9694-4845-ab4e-3d0a3789e810 53808-0636 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20130901 ANDA ANDA078993 State of Florida DOH Central Pharmacy LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 53808-0639_fe96ad53-5780-4544-89c5-05f18b25b4c7 53808-0639 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA078643 State of Florida DOH Central Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 53808-0643_16c097f9-0493-4a50-9486-6f993fab4937 53808-0643 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090701 ANDA ANDA076795 State of Florida DOH Central Pharmacy LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 53808-0644_70202a73-7bee-4596-96f8-96154d758841 53808-0644 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 20090701 ANDA ANDA040319 State of Florida DOH Central Pharmacy DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 53808-0646_9607ed40-8d81-4476-ad94-a3d9f5a4997a 53808-0646 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20130101 ANDA ANDA076921 State of Florida DOH Central Pharmacy MIRTAZAPINE 15 mg/1 E 20171231 53808-0647_fdee2c6d-0343-43e4-9031-aea90341e5ef 53808-0647 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20090701 ANDA ANDA077042 State of Florida DOH Central Pharmacy CITALOPRAM 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0648_266007f1-3e2f-4142-92c2-cdb20fb73f99 53808-0648 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20090701 ANDA ANDA075479 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 53808-0650_7e55b122-534a-4fcc-9b47-f7263d25b363 53808-0650 HUMAN PRESCRIPTION DRUG ISENTRESS raltegravir TABLET, FILM COATED ORAL 20090701 NDA NDA022145 State of Florida DOH Central Pharmacy RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] N 20181231 53808-0652_d11a28f5-d648-44c5-955c-02259fa53884 53808-0652 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20090701 ANDA ANDA040298 State of Florida DOH Central Pharmacy PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 53808-0653_24efe210-73f3-446c-a8d3-88baa1508702 53808-0653 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20090701 ANDA ANDA076418 State of Florida DOH Central Pharmacy AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-0654_ff1989ff-b72f-4071-b121-ed099cef0a9f 53808-0654 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20090701 ANDA ANDA071207 State of Florida DOH Central Pharmacy HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] N 20181231 53808-0655_2f9e9ab0-e535-46e9-9f50-20bb433e38f9 53808-0655 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA078902 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0656_66893c23-b206-4107-ad2b-1af596b4c5c5 53808-0656 HUMAN PRESCRIPTION DRUG ZERIT stavudine CAPSULE, GELATIN COATED ORAL 20090701 NDA NDA020412 State of Florida DOH Central Pharmacy STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0657_66893c23-b206-4107-ad2b-1af596b4c5c5 53808-0657 HUMAN PRESCRIPTION DRUG ZERIT stavudine CAPSULE, GELATIN COATED ORAL 20090701 NDA NDA020412 State of Florida DOH Central Pharmacy STAVUDINE 30 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0658_66c085b7-3ec3-43b4-a095-e04cf8d7a76a 53808-0658 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA078512 State of Florida DOH Central Pharmacy ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0659_6fe65de6-b8ac-4d1a-b9b0-834bac4a6aac 53808-0659 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate METOPROLOL TARTRATE TABLET ORAL 20090701 ANDA ANDA076670 State of Florida DOH Central Pharmacy METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0660_66c085b7-3ec3-43b4-a095-e04cf8d7a76a 53808-0660 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA078512 State of Florida DOH Central Pharmacy ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0661_b34e05d5-b64b-42d0-a121-f5e21dfc3c1b 53808-0661 HUMAN PRESCRIPTION DRUG CRIXIVAN indinavir sulfate CAPSULE ORAL 20090701 NDA NDA020685 State of Florida DOH Central Pharmacy INDINAVIR SULFATE 400 mg/1 E 20171231 53808-0662_6a12a175-287e-48ae-bd9b-b267e7e28567 53808-0662 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide TABLET ORAL 20090701 ANDA ANDA075907 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 53808-0663_266007f1-3e2f-4142-92c2-cdb20fb73f99 53808-0663 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20090701 ANDA ANDA075479 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 53808-0664_51a71da6-5750-47fa-bf22-8f227ff4288b 53808-0664 HUMAN PRESCRIPTION DRUG Perphenazine PERPHENAZINE TABLET, FILM COATED ORAL 20090701 ANDA ANDA089686 State of Florida DOH Central Pharmacy PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53808-0665_51a71da6-5750-47fa-bf22-8f227ff4288b 53808-0665 HUMAN PRESCRIPTION DRUG Perphenazine PERPHENAZINE TABLET, FILM COATED ORAL 20090701 ANDA ANDA089684 State of Florida DOH Central Pharmacy PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53808-0668_feb3b39a-cb33-4b75-8ed9-a991ee25d31e 53808-0668 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20090701 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 53808-0671_4d0ada65-a960-4229-8e17-3f33e4b9e8db 53808-0671 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130101 ANDA ANDA078010 State of Florida DOH Central Pharmacy FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 53808-0672_293699e1-d0c8-4d54-b360-e76b26b7da68 53808-0672 HUMAN PRESCRIPTION DRUG PREZISTA darunavir ethanolate TABLET, FILM COATED ORAL 20090701 NDA NDA021976 State of Florida DOH Central Pharmacy DARUNAVIR ETHANOLATE 400 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 53808-0673_206f82e1-b242-4862-81a1-daec96ce745e 53808-0673 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20090701 ANDA ANDA077836 State of Florida DOH Central Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 53808-0674_e981c067-b7f7-440b-a4d3-1cd79038af4a 53808-0674 HUMAN PRESCRIPTION DRUG Invirase saquinavir mesylate TABLET, FILM COATED ORAL 20090701 NDA NDA021785 State of Florida DOH Central Pharmacy SAQUINAVIR MESYLATE 500 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] N 20181231 53808-0677_1563f468-2a2d-4f15-a04c-9a37c3c24996 53808-0677 HUMAN OTC DRUG DocQLace docusate sodium CAPSULE ORAL 20130101 OTC MONOGRAPH NOT FINAL part334 State of Florida DOH Central Pharmacy DOCUSATE SODIUM 100 mg/1 E 20171231 53808-0678_7b9ff69e-983f-4746-b250-9276642e2846 53808-0678 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20130101 ANDA ANDA074550 State of Florida DOH Central Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 53808-0679_e3450a89-d439-4835-a9ca-fee52563bdcf 53808-0679 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20130101 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 53808-0680_e15b05c5-0ba5-4f29-985a-63d8ec3f97af 53808-0680 HUMAN PRESCRIPTION DRUG Nevirapine nevirapine TABLET ORAL 20130101 ANDA ANDA202523 State of Florida DOH Central Pharmacy NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 53808-0681_dd72b287-cb96-414f-9e0d-a9313d1cbf73 53808-0681 HUMAN PRESCRIPTION DRUG Divalproex Sodium Delayed-Release Divalproex Sodium TABLET, FILM COATED ORAL 20130101 ANDA ANDA090210 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 53808-0682_e18fe82b-fe72-4952-816b-0900e62361fd 53808-0682 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride Hemihydrate TABLET, FILM COATED ORAL 20130101 ANDA ANDA077584 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0683_9b9bc863-13d3-4a5c-83ac-5dca8b28d37b 53808-0683 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130101 ANDA ANDA078040 State of Florida DOH Central Pharmacy RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 53808-0684_0db574c6-0270-4fbc-af7d-19cfdcc88e7c 53808-0684 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20130101 OTC MONOGRAPH FINAL part331 State of Florida DOH Central Pharmacy MAGNESIUM OXIDE 400 mg/1 E 20171231 53808-0685_165010e0-5a9f-4e65-be43-ddb6999b5666 53808-0685 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20130101 ANDA ANDA077751 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-0686_9ee8ed6b-bedd-409f-9736-a23e75e05e48 53808-0686 HUMAN PRESCRIPTION DRUG Amlodipine AMLODIPINE BESYLATE TABLET ORAL 20130101 ANDA ANDA078231 State of Florida DOH Central Pharmacy AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-0687_d73a6e72-d76f-4d31-9e91-32cd709aef51 53808-0687 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130101 ANDA ANDA078332 State of Florida DOH Central Pharmacy CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 53808-0688_9a2813cb-5745-4ca0-95cd-57de74105ec5 53808-0688 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130101 ANDA ANDA077691 State of Florida DOH Central Pharmacy SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-0689_954c5c83-5d35-4cc9-a5da-df5c74300415 53808-0689 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20130101 ANDA ANDA078955 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0690_a137a53d-e0b8-4e5b-9569-cb28d1ed4d3e 53808-0690 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20130101 ANDA ANDA091576 State of Florida DOH Central Pharmacy MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 53808-0691_dca3de0d-f025-4602-af83-efd391b8623b 53808-0691 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130101 ANDA ANDA078225 State of Florida DOH Central Pharmacy TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 53808-0692_a6d8c6e6-4587-48b8-b9da-a32cf6f44790 53808-0692 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130101 ANDA ANDA076063 State of Florida DOH Central Pharmacy LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 53808-0693_f270b06b-e60d-41e3-88bc-9599737f8dba 53808-0693 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130101 ANDA ANDA077127 State of Florida DOH Central Pharmacy NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-0695_e5e7eb22-fc88-4fc8-a047-1d785435448a 53808-0695 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20130101 ANDA ANDA074984 State of Florida DOH Central Pharmacy DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 53808-0696_aff840f1-ccb7-4e19-bb26-194f414ff05d 53808-0696 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20130101 ANDA ANDA084364 State of Florida DOH Central Pharmacy TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 E 20171231 53808-0699_44db61fc-c25f-4c69-b466-00423c7ca9e8 53808-0699 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20130101 ANDA ANDA078556 State of Florida DOH Central Pharmacy DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 53808-0700_dd158c6f-db49-4875-a5f2-853947200bf1 53808-0700 HUMAN PRESCRIPTION DRUG Lisinopril LISINOPRIL TABLET ORAL 20090701 ANDA ANDA077622 State of Florida DOH Central Pharmacy LISINOPRIL 10 mg/1 E 20171231 53808-0701_0fe688ac-da62-4889-a8b8-82babe390ad3 53808-0701 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20090701 ANDA ANDA075944 State of Florida DOH Central Pharmacy LISINOPRIL 20 mg/1 E 20171231 53808-0702_68a98d1d-a74f-4d43-9ebe-c50795b3975b 53808-0702 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20090701 ANDA ANDA076071 State of Florida DOH Central Pharmacy LISINOPRIL 20 mg/1 N 20181231 53808-0703_27c6283e-54e1-4ae0-a07a-dc71d92a6de2 53808-0703 HUMAN PRESCRIPTION DRUG Lisinopril LISINOPRIL TABLET ORAL 20090701 ANDA ANDA076059 State of Florida DOH Central Pharmacy LISINOPRIL 20 mg/1 E 20171231 53808-0704_ad095c76-cd86-41c4-b54a-6a1db4fa200c 53808-0704 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090701 ANDA ANDA079139 State of Florida DOH Central Pharmacy LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 53808-0705_fbd9e5c2-570f-4fa1-9ffd-adbf96cb4a5e 53808-0705 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 20090701 NDA NDA017812 State of Florida DOH Central Pharmacy LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 53808-0707_de0592d5-7e0e-41bb-af4d-62d1bdddb668 53808-0707 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE CAPSULE ORAL 20090701 ANDA ANDA073192 State of Florida DOH Central Pharmacy LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 53808-0712_45abd94e-142e-4da8-ad7b-566a18395935 53808-0712 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20090701 ANDA ANDA078170 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 53808-0713_b01de40c-1f85-4255-bcf2-31540bca206a 53808-0713 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075967 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 53808-0717_45abd94e-142e-4da8-ad7b-566a18395935 53808-0717 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20090701 ANDA ANDA078170 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 53808-0718_b01de40c-1f85-4255-bcf2-31540bca206a 53808-0718 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075967 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 53808-0720_b01de40c-1f85-4255-bcf2-31540bca206a 53808-0720 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075967 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 53808-0722_7dc3385b-d2bb-472e-b05d-67124e346bb4 53808-0722 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20090701 ANDA ANDA071250 State of Florida DOH Central Pharmacy METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 53808-0723_7dc3385b-d2bb-472e-b05d-67124e346bb4 53808-0723 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20090701 ANDA ANDA072750 State of Florida DOH Central Pharmacy METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 53808-0725_f59d2f6d-b2ff-418e-92fc-e00ccd7d63ff 53808-0725 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA076704 State of Florida DOH Central Pharmacy METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 53808-0728_f59d2f6d-b2ff-418e-92fc-e00ccd7d63ff 53808-0728 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA076704 State of Florida DOH Central Pharmacy METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 53808-0730_81b9fca7-f47d-4293-87ae-856c4b1c5f96 53808-0730 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA076900 State of Florida DOH Central Pharmacy ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0731_684d8704-b4f4-4c9a-a775-fa59a3299843 53808-0731 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20090701 ANDA ANDA074680 State of Florida DOH Central Pharmacy RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 53808-0733_95f59b4c-5958-41aa-be62-69b861a151e1 53808-0733 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20090701 ANDA ANDA071839 DOH CENTRAL PHARMACY MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 53808-0734_95f59b4c-5958-41aa-be62-69b861a151e1 53808-0734 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20090701 ANDA ANDA071839 DOH CENTRAL PHARMACY MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 53808-0735_63cbcedb-7dfd-4ec5-ae64-d6c87e1b2b5d 53808-0735 HUMAN PRESCRIPTION DRUG Mirtazapine MIRTAZAPINE TABLET ORAL 20090701 ANDA ANDA076541 State of Florida DOH Central Pharmacy MIRTAZAPINE 15 mg/1 E 20171231 53808-0736_63cbcedb-7dfd-4ec5-ae64-d6c87e1b2b5d 53808-0736 HUMAN PRESCRIPTION DRUG Mirtazapine MIRTAZAPINE TABLET ORAL 20090701 ANDA ANDA076541 State of Florida DOH Central Pharmacy MIRTAZAPINE 30 mg/1 E 20171231 53808-0737_63cbcedb-7dfd-4ec5-ae64-d6c87e1b2b5d 53808-0737 HUMAN PRESCRIPTION DRUG Mirtazapine MIRTAZAPINE TABLET ORAL 20090701 ANDA ANDA076541 State of Florida DOH Central Pharmacy MIRTAZAPINE 45 mg/1 E 20171231 53808-0738_88ea22b4-1004-478a-b914-09dd77dde766 53808-0738 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090701 ANDA ANDA075927 State of Florida DOH Central Pharmacy NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 53808-0739_e142bb87-30bf-4ef5-a58d-254f35faad1d 53808-0739 HUMAN PRESCRIPTION DRUG Naproxen NAPROXEN TABLET ORAL 20090701 ANDA ANDA074201 State of Florida DOH Central Pharmacy NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 53808-0740_d8728514-ee4d-474e-a002-fa8a70f9eb10 53808-0740 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20090701 ANDA ANDA065093 State of Florida DOH Central Pharmacy AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 53808-0742_e46640dd-311d-4e68-9424-7c4c7ade7847 53808-0742 HUMAN PRESCRIPTION DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, FILM COATED ORAL 20090701 ANDA ANDA074201 State of Florida DOH Central Pharmacy NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53808-0744_cb95c93f-4e5e-4ae7-a755-b24d2d6e6474 53808-0744 HUMAN PRESCRIPTION DRUG nifedipine NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA075108 State of Florida DOH Central Pharmacy NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-0745_4c58bcb1-6e1f-44cd-a542-305c8b9898ce 53808-0745 HUMAN PRESCRIPTION DRUG Omeprazole Delayed-Release OMEPRAZOLE CAPSULE, DELAYED RELEASE ORAL 20090701 ANDA ANDA076048 DOH CENTRAL PHARMACY OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 53808-0746_596008d9-a14e-42a8-b2f4-799480123e7b 53808-0746 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090701 ANDA ANDA075876 State of Florida DOH Central Pharmacy OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 53808-0747_80e61d72-77a8-4d3f-b251-7b3272351d33 53808-0747 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride OXYBUTYNIN CHLORIDE TABLET ORAL 20090701 ANDA ANDA071655 State of Florida DOH Central Pharmacy OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 53808-0748_051db7fe-e4d6-4022-a00a-069d14dbaf64 53808-0748 HUMAN PRESCRIPTION DRUG paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075356 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0749_1738a5ed-a001-4b9f-b16e-e10b06833354 53808-0749 HUMAN PRESCRIPTION DRUG Paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA078406 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0750_051db7fe-e4d6-4022-a00a-069d14dbaf64 53808-0750 HUMAN PRESCRIPTION DRUG paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075356 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0752_1738a5ed-a001-4b9f-b16e-e10b06833354 53808-0752 HUMAN PRESCRIPTION DRUG Paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA078406 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0753_051db7fe-e4d6-4022-a00a-069d14dbaf64 53808-0753 HUMAN PRESCRIPTION DRUG paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075356 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0754_051db7fe-e4d6-4022-a00a-069d14dbaf64 53808-0754 HUMAN PRESCRIPTION DRUG paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA075356 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0755_0ea2345f-d110-4f6a-af82-cf862207127c 53808-0755 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20090701 NDA NDA018832 State of Florida DOH Central Pharmacy ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 53808-0756_1738a5ed-a001-4b9f-b16e-e10b06833354 53808-0756 HUMAN PRESCRIPTION DRUG Paroxetine PAROXETINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA078406 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0757_b775b613-a690-459c-b0ea-2798a74df5e2 53808-0757 HUMAN PRESCRIPTION DRUG Pentoxifylline PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 20090701 ANDA ANDA075199 State of Florida DOH Central Pharmacy PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] E 20171231 53808-0758_176f8340-f270-4873-87e5-b53323a2b6ee 53808-0758 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA074425 State of Florida DOH Central Pharmacy PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] E 20171231 53808-0759_e30a8bdd-87ca-4886-a55e-d807763bd4c6 53808-0759 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20090701 ANDA ANDA065189 State of Florida DOH Central Pharmacy AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 53808-0760_51a71da6-5750-47fa-bf22-8f227ff4288b 53808-0760 HUMAN PRESCRIPTION DRUG Perphenazine PERPHENAZINE TABLET, FILM COATED ORAL 20090701 ANDA ANDA089685 State of Florida DOH Central Pharmacy PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 53808-0761_533b9303-6097-4eee-a802-d7623461b82a 53808-0761 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, SUGAR COATED ORAL 20090701 ANDA ANDA040226 State of Florida DOH Central Pharmacy PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 53808-0762_51a71da6-5750-47fa-bf22-8f227ff4288b 53808-0762 HUMAN PRESCRIPTION DRUG Perphenazine PERPHENAZINE TABLET, FILM COATED ORAL 20090701 ANDA ANDA089686 State of Florida DOH Central Pharmacy PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 53808-0763_510501a7-61be-4fa1-8120-4bd218a01d8d 53808-0763 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 20090701 NDA NDA020839 State of Florida DOH Central Pharmacy CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 53808-0764_9db1257e-0491-4c8d-85d6-37fa1f425cbd 53808-0764 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20090701 ANDA ANDA077987 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-0765_c8f33b49-5160-402f-b094-249b29b0fad0 53808-0765 HUMAN PRESCRIPTION DRUG Pravastatin Sodium PRAVASTATIN SODIUM TABLET ORAL 20090701 ANDA ANDA076056 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-0766_c8f33b49-5160-402f-b094-249b29b0fad0 53808-0766 HUMAN PRESCRIPTION DRUG Pravastatin Sodium PRAVASTATIN SODIUM TABLET ORAL 20090701 ANDA ANDA076056 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-0767_74505e7d-79df-4432-83b4-dc03d441e0cd 53808-0767 HUMAN PRESCRIPTION DRUG EPZICOM abacavir sulfate and lamivudine TABLET, FILM COATED ORAL 20090701 NDA NDA021652 State of Florida DOH Central Pharmacy ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0768_c8f33b49-5160-402f-b094-249b29b0fad0 53808-0768 HUMAN PRESCRIPTION DRUG Pravastatin Sodium PRAVASTATIN SODIUM TABLET ORAL 20090701 ANDA ANDA076056 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-0770_3144f373-fd53-433e-bcc3-7de919cfb475 53808-0770 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20090701 NDA NDA004782 State of Florida DOH Central Pharmacy ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] E 20171231 53808-0771_d6ad4be2-e6ec-4e44-8609-fd9ec50aacab 53808-0771 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20090701 ANDA ANDA070176 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0772_d6ad4be2-e6ec-4e44-8609-fd9ec50aacab 53808-0772 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20090701 ANDA ANDA070177 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0773_293699e1-d0c8-4d54-b360-e76b26b7da68 53808-0773 HUMAN PRESCRIPTION DRUG PREZISTA darunavir ethanolate TABLET, FILM COATED ORAL 20090701 NDA NDA021976 State of Florida DOH Central Pharmacy DARUNAVIR ETHANOLATE 600 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 53808-0774_8ec6d8b3-9152-4154-91ea-48ab5bfd1968 53808-0774 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20090701 ANDA ANDA075180 State of Florida DOH Central Pharmacy RANITIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 53808-0775_23799e22-8ede-40fd-a9cb-a5ba4fd484a0 53808-0775 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20090701 ANDA ANDA077824 State of Florida DOH Central Pharmacy RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 53808-0776_28f0dfb6-0724-413f-bd98-d8421482e9ff 53808-0776 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA074467 State of Florida DOH Central Pharmacy RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 53808-0777_5ec67fac-794f-4ca5-a5ef-6a0cf51565e0 53808-0777 HUMAN PRESCRIPTION DRUG Renagel Renagel TABLET ORAL 20090701 NDA NDA021179 DOH CENTRAL PHARMACY SEVELAMER HYDROCHLORIDE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 53808-0781_cbb7cff7-62dd-4bb5-aee5-4202eb730940 53808-0781 HUMAN PRESCRIPTION DRUG Ribavirin RIBAVIRIN CAPSULE ORAL 20090701 ANDA ANDA076192 State of Florida DOH Central Pharmacy RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] E 20171231 53808-0782_e6e8d35d-d5c7-4149-9167-b7e2d0588bee 53808-0782 HUMAN PRESCRIPTION DRUG Ribavirin RIBAVIRIN TABLET, FILM COATED ORAL 20090701 ANDA ANDA077224 State of Florida DOH Central Pharmacy RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] E 20171231 53808-0783_df05a7ce-0e25-4c7c-a69d-1e1b9e13de61 53808-0783 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 State of Florida DOH Central Pharmacy RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 53808-0784_df05a7ce-0e25-4c7c-a69d-1e1b9e13de61 53808-0784 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 State of Florida DOH Central Pharmacy RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 53808-0786_df05a7ce-0e25-4c7c-a69d-1e1b9e13de61 53808-0786 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090701 ANDA ANDA079088 State of Florida DOH Central Pharmacy RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 53808-0787_4eae84af-ae77-47c6-ade9-e78a26d33b59 53808-0787 HUMAN PRESCRIPTION DRUG Intelence Etravirine TABLET ORAL 20090701 NDA NDA022187 State of Florida DOH Central Pharmacy ETRAVIRINE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 53808-0790_eef23738-e47f-4c37-a3b0-fc8f641bb351 53808-0790 HUMAN PRESCRIPTION DRUG simvastatin SIMVASTATIN TABLET, FILM COATED ORAL 20090701 ANDA ANDA078103 DOH CENTRAL PHARMACY SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-0791_eef23738-e47f-4c37-a3b0-fc8f641bb351 53808-0791 HUMAN PRESCRIPTION DRUG simvastatin SIMVASTATIN TABLET, FILM COATED ORAL 20090701 ANDA ANDA078103 DOH CENTRAL PHARMACY SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-0792_d080c03c-ff61-4a31-9a91-25b5a515d77a 53808-0792 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20090701 ANDA ANDA076052 State of Florida DOH Central Pharmacy SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-0793_a77a8615-6c1e-4571-b228-7783cfb5c48d 53808-0793 HUMAN PRESCRIPTION DRUG Simvastatin SIMVASTATIN TABLET, FILM COATED ORAL 20090701 ANDA ANDA076285 State of Florida DOH Central Pharmacy SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-0794_eef23738-e47f-4c37-a3b0-fc8f641bb351 53808-0794 HUMAN PRESCRIPTION DRUG simvastatin SIMVASTATIN TABLET, FILM COATED ORAL 20090701 ANDA ANDA078103 DOH CENTRAL PHARMACY SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-0795_66893c23-b206-4107-ad2b-1af596b4c5c5 53808-0795 HUMAN PRESCRIPTION DRUG ZERIT stavudine CAPSULE, GELATIN COATED ORAL 20090701 NDA NDA020412 State of Florida DOH Central Pharmacy STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0796_e1a6cafb-dc98-4630-9cbe-519e08ab1691 53808-0796 HUMAN PRESCRIPTION DRUG Spironolactone SPIRONOLACTONE TABLET ORAL 20090701 ANDA ANDA040353 State of Florida DOH Central Pharmacy SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 53808-0797_bc8c902a-bbb9-46fb-ba2f-0da5862699ac 53808-0797 HUMAN PRESCRIPTION DRUG Sucralfate SUCRALFATE TABLET ORAL 20090701 ANDA ANDA070848 State of Florida DOH Central Pharmacy SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 53808-0798_af332a04-0159-48e0-a069-f30c617181c5 53808-0798 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20090701 ANDA ANDA076899 State of Florida DOH Central Pharmacy SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 53808-0799_c1d1c61f-8039-4ce0-aeae-e9834e88f032 53808-0799 HUMAN PRESCRIPTION DRUG Sulindac SULINDAC TABLET ORAL 20090701 ANDA ANDA073262 State of Florida DOH Central Pharmacy SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 53808-0800_bf27bfc4-b913-4924-bebf-a0bdbaddcea5 53808-0800 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130101 ANDA ANDA077837 State of Florida DOH Central Pharmacy SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-0801_cbe7f06f-5d03-478a-b878-e9149a9cc853 53808-0801 HUMAN PRESCRIPTION DRUG Emtriva emtricitabine CAPSULE ORAL 20090701 NDA NDA021500 State of Florida DOH Central Pharmacy EMTRICITABINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 53808-0803_664e2ae4-54af-470c-80a6-039825757663 53808-0803 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE ORAL 20090701 ANDA ANDA074821 State of Florida DOH Central Pharmacy TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 53808-0804_49974c21-8cf2-4f7f-b768-560e2fbe7b60 53808-0804 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090701 ANDA ANDA071851 State of Florida DOH Central Pharmacy TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 53808-0805_877e3186-0c6f-47e4-b946-2fe53d80ef12 53808-0805 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20090701 NDA NDA021752 State of Florida DOH Central Pharmacy EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 53808-0806_28c48b4c-4ef3-4047-b3c3-3ef51ff98532 53808-0806 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20130101 ANDA ANDA090494 State of Florida DOH Central Pharmacy CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 53808-0807_a35648a5-edad-466e-97cf-fc1ce7993bce 53808-0807 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA074330 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 53808-0808_46b0051f-5908-4d1d-967b-4085a0909b4a 53808-0808 HUMAN PRESCRIPTION DRUG Viramune nevirapine TABLET ORAL 20090701 NDA NDA020636 State of Florida DOH Central Pharmacy NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] E 20171231 53808-0809_d93799ad-308b-4f54-b8d5-07402cd8882e 53808-0809 HUMAN PRESCRIPTION DRUG Viracept NELFINAVIR MESYLATE TABLET, FILM COATED ORAL 20090701 NDA NDA021503 State of Florida DOH Central Pharmacy NELFINAVIR MESYLATE 625 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] N 20181231 53808-0810_bea0f43d-4f45-40d2-b4a4-3ac996bb1626 53808-0810 HUMAN PRESCRIPTION DRUG Viread tenofovir disoproxil fumarate TABLET, COATED ORAL 20090701 NDA NDA021356 State of Florida DOH Central Pharmacy TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 N 20181231 53808-0811_dd74d4f9-ed20-47b0-bb3d-4a8ad228a21e 53808-0811 HUMAN PRESCRIPTION DRUG ZIAGEN abacavir sulfate TABLET, FILM COATED ORAL 20090701 NDA NDA020977 State of Florida DOH Central Pharmacy ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0812_5ecb9e06-5d39-4c3f-87dd-0e8722232880 53808-0812 HUMAN PRESCRIPTION DRUG Zidovudine ZIDOVUDINE TABLET, FILM COATED ORAL 20090701 ANDA ANDA077267 DOH CENTRAL PHARMACY ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 53808-0813_c8b695f2-24f9-4546-b94f-7fce9a5439dc 53808-0813 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20130101 ANDA ANDA070217 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0814_123676fd-fb30-4627-b6e8-def7d4e41931 53808-0814 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20130101 ANDA ANDA072711 State of Florida DOH Central Pharmacy SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53808-0815_d73a6e72-d76f-4d31-9e91-32cd709aef51 53808-0815 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130101 ANDA ANDA078332 State of Florida DOH Central Pharmacy CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 53808-0816_9a2813cb-5745-4ca0-95cd-57de74105ec5 53808-0816 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130101 ANDA ANDA077691 State of Florida DOH Central Pharmacy SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-0817_75e3fbcc-e08b-41de-83a3-090f7fb39643 53808-0817 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 20130101 ANDA ANDA071093 State of Florida DOH Central Pharmacy THIOTHIXENE 10 mg/1 Typical Antipsychotic [EPC] E 20171231 53808-0819_a93001d2-6248-4c2b-b84a-a7458c232f0c 53808-0819 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA040209 State of Florida DOH Central Pharmacy TRIFLUOPERAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 53808-0820_d73a6e72-d76f-4d31-9e91-32cd709aef51 53808-0820 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130101 ANDA ANDA078332 State of Florida DOH Central Pharmacy CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 53808-0821_de44300b-0179-42f7-86cd-ae9b79501222 53808-0821 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131201 ANDA ANDA074556 State of Florida DOH Central Pharmacy ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 53808-0822_41c99d5e-a695-4aba-8131-6104068368c5 53808-0822 HUMAN OTC DRUG MAPAP Extra Strength Acetaminophen CAPSULE ORAL 20130101 OTC MONOGRAPH NOT FINAL part343 State of Florida DOH Central Pharmacy ACETAMINOPHEN 500 mg/1 E 20171231 53808-0823_51806be1-d5f5-4a7c-afba-12ebd6234980 53808-0823 HUMAN PRESCRIPTION DRUG ASACOL mesalamine TABLET, DELAYED RELEASE ORAL 20130101 NDA NDA019651 State of Florida DOH Central Pharmacy MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 53808-0825_6e264c7b-8a87-4f75-8644-ba41b9f4398b 53808-0825 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130101 ANDA ANDA040715 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 53808-0826_9405fe87-9769-4bd3-a38c-1fe354a02d7e 53808-0826 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20130101 ANDA ANDA040103 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 53808-0827_61da2442-b0df-44ae-b055-a6aaef3ab5b3 53808-0827 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130101 ANDA ANDA076649 State of Florida DOH Central Pharmacy CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 53808-0828_df961314-befe-4003-b46a-03f711a8b627 53808-0828 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20130101 ANDA ANDA077901 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53808-0829_598c0f12-a32a-4fca-a2e7-afee666bb964 53808-0829 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20130101 ANDA ANDA087056 State of Florida DOH Central Pharmacy CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 E 20171231 53808-0830_d7549854-f546-4224-af14-2aee940409da 53808-0830 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA072838 State of Florida DOH Central Pharmacy DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 53808-0831_970a776f-2cac-4d2e-be54-e10a3af85ec4 53808-0831 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130101 ANDA ANDA077567 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 53808-0832_6366bd5f-d29d-4d9e-b932-b3b91b2e4b78 53808-0832 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20130101 ANDA ANDA062396 State of Florida DOH Central Pharmacy DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 53808-0833_0b7b2424-cd18-4524-b974-5266a537dda3 53808-0833 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20130101 ANDA ANDA075479 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 53808-0834_afaee673-4a3b-4204-b20b-4dd229c26dfd 53808-0834 HUMAN OTC DRUG Excedrin Extra Strength Acetaminophen, Aspirin (NSAID), and Caffeine TABLET, FILM COATED ORAL 20130101 OTC MONOGRAPH NOT FINAL part343 State of Florida DOH Central Pharmacy ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 E 20171231 53808-0835_b7ef153b-d459-49e9-ac4a-c7744a7fc9ed 53808-0835 HUMAN OTC DRUG EXCEDRIN MIGRAINE Acetaminophen, Aspirin (NSAID) and Caffeine TABLET, FILM COATED ORAL 20130101 NDA NDA020802 State of Florida DOH Central Pharmacy ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 E 20171231 53808-0836_4e5a0dbd-daa9-4d86-af17-4cd53ebed71d 53808-0836 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine hydrochloride CAPSULE ORAL 20120601 ANDA ANDA075207 State of Florida DOH Central Pharmacy FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0837_850b50af-9e8a-4272-a644-6531f1d54919 53808-0837 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20130101 ANDA ANDA075452 State of Florida DOH Central Pharmacy FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0838_0b2c2616-3c2a-40c7-b158-16a35a500cb7 53808-0838 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20130101 ANDA ANDA075034 State of Florida DOH Central Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 53808-0839_30926b4a-aab1-4299-b552-1b99dfd20cab 53808-0839 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20130101 ANDA ANDA070082 State of Florida DOH Central Pharmacy FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 53808-0840_b252f4a8-1e2d-48b0-9296-dc9681acdcf7 53808-0840 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20130101 ANDA ANDA070278 State of Florida DOH Central Pharmacy HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] E 20171231 53808-0841_93b2b693-3119-426e-bcca-4ae59380c69a 53808-0841 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20130101 ANDA ANDA075907 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 53808-0842_f60eada4-f96e-4e0a-a370-932874aec744 53808-0842 HUMAN PRESCRIPTION DRUG Ketoconazole ketoconazole TABLET ORAL 20130101 ANDA ANDA075597 State of Florida DOH Central Pharmacy KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 53808-0843_00a2a441-b79b-408e-a906-f8292056e8f6 53808-0843 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20130101 ANDA ANDA091606 State of Florida DOH Central Pharmacy LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0844_00a2a441-b79b-408e-a906-f8292056e8f6 53808-0844 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20130101 ANDA ANDA091606 State of Florida DOH Central Pharmacy LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0846_ad9a1593-1009-4afd-8d15-4f324815d6b0 53808-0846 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130101 NDA NDA021210 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 53808-0848_4fb8b0cb-c11c-4a61-89b1-7296991ec647 53808-0848 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120101 ANDA ANDA077095 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 53808-0849_e43cb91f-a1b4-4d46-beba-35f2057913a9 53808-0849 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20130101 ANDA ANDA077064 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 53808-0850_d4bf45c5-6b50-430a-84e6-c3d62fd2a9cf 53808-0850 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20130101 ANDA ANDA040350 State of Florida DOH Central Pharmacy METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] E 20171231 53808-0851_543b34f9-d0d4-47bb-ad9a-b3b7eaec442e 53808-0851 HUMAN PRESCRIPTION DRUG Nifedical XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130101 ANDA ANDA075289 State of Florida DOH Central Pharmacy NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 53808-0852_5f18c60b-648b-404a-858f-00ddaa9b0be1 53808-0852 HUMAN PRESCRIPTION DRUG Stavudine stavudine CAPSULE ORAL 20130101 ANDA ANDA079069 State of Florida DOH Central Pharmacy STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0856_db45c4b3-9d13-44dd-9b8d-b2ae6a2c4c36 53808-0856 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20130101 ANDA ANDA074253 State of Florida DOH Central Pharmacy BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 53808-0858_a1e16d44-3bdd-4efd-bad2-9416a826be83 53808-0858 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET, CHEWABLE ORAL 20130101 ANDA ANDA075712 State of Florida DOH Central Pharmacy CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 53808-0859_d73a6e72-d76f-4d31-9e91-32cd709aef51 53808-0859 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130101 ANDA ANDA078332 State of Florida DOH Central Pharmacy CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 53808-0862_9fc869dc-7e21-43b0-8170-e25bb74365f2 53808-0862 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA073541 State of Florida DOH Central Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 53808-0863_9ae2f08d-e20b-46e3-b0f8-67118a65f662 53808-0863 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20130101 ANDA ANDA078012 State of Florida DOH Central Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 53808-0867_1787bada-5b5a-4e0c-8bf7-4b695544eaa5 53808-0867 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130101 ANDA ANDA075743 State of Florida DOH Central Pharmacy LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 53808-0868_5584341f-746e-4791-a1fa-36b5e8c865d1 53808-0868 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130101 ANDA ANDA076059 State of Florida DOH Central Pharmacy LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53808-0870_1787bada-5b5a-4e0c-8bf7-4b695544eaa5 53808-0870 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130101 ANDA ANDA075743 State of Florida DOH Central Pharmacy LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 53808-0871_857ee4e5-bcbf-4e1b-afb2-a98507a8d3bb 53808-0871 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130101 NDA NDA021282 State of Florida DOH Central Pharmacy GUAIFENESIN 600 mg/1 E 20171231 53808-0872_5e9234b6-72b6-443a-8a75-a68de18e98c9 53808-0872 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20130101 ANDA ANDA078432 State of Florida DOH Central Pharmacy NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53808-0873_7e123e63-4a3a-4a7a-8b45-e3d5ef102106 53808-0873 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20130101 ANDA ANDA074625 State of Florida DOH Central Pharmacy OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 53808-0874_dcafbc91-8eb4-4682-bf89-b16dd412be7a 53808-0874 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20130101 ANDA ANDA077751 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-0875_dcafbc91-8eb4-4682-bf89-b16dd412be7a 53808-0875 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20130101 ANDA ANDA077751 State of Florida DOH Central Pharmacy PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-0876_76437cab-3ca6-4e54-9c58-803f50404969 53808-0876 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20130101 ANDA ANDA076288 State of Florida DOH Central Pharmacy RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] E 20171231 53808-0877_2c92f80c-2f2d-472c-9937-ee9c4e6ab1a0 53808-0877 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20130101 ANDA ANDA061837 State of Florida DOH Central Pharmacy TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 53808-0878_0602ce68-264c-4b34-b2f0-fb0f623bbde3 53808-0878 HUMAN PRESCRIPTION DRUG Zidovudine zidovudine TABLET, FILM COATED ORAL 20130101 ANDA ANDA078922 State of Florida DOH Central Pharmacy ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0880_d47df14d-46f6-4b35-ae73-4a9b59825c31 53808-0880 HUMAN OTC DRUG Allergy Time Chlorpheniramine Maleate TABLET ORAL 20130101 OTC MONOGRAPH FINAL part341 State of Florida DOH Central Pharmacy CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 53808-0881_fe96ad53-5780-4544-89c5-05f18b25b4c7 53808-0881 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20130101 ANDA ANDA078643 State of Florida DOH Central Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 53808-0882_104c0170-6b56-415e-90b4-85f777ba2792 53808-0882 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20130101 ANDA ANDA090527 State of Florida DOH Central Pharmacy HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 53808-0883_16798eff-96a1-4d88-8ece-b75a2e7dba48 53808-0883 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130101 ANDA ANDA040809 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 53808-0884_9d1794d1-822d-4ca7-9cad-6582a965df9a 53808-0884 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20140101 ANDA ANDA079139 State of Florida DOH Central Pharmacy LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 53808-0885_6a4cea14-a6b0-4d95-a7cf-b14a6bdab0ce 53808-0885 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20140101 ANDA ANDA040226 State of Florida DOH Central Pharmacy PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 53808-0886_1411c929-e5e8-49cd-a165-947ba82b80f4 53808-0886 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140101 ANDA ANDA201507 State of Florida DOH Central Pharmacy HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 53808-0887_ac228abb-ea52-4688-a175-8ad02b651fa0 53808-0887 HUMAN PRESCRIPTION DRUG Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20140101 NDA NDA203100 State of Florida DOH Central Pharmacy ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 150; 150; 200; 300 mg/1; mg/1; mg/1; mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 53808-0888_f34f024f-04c2-4a36-83a4-5b2a75aaa8fc 53808-0888 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140101 ANDA ANDA077321 State of Florida DOH Central Pharmacy LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 53808-0889_425b8fc9-64d0-435f-9e42-1fc2d19b5be3 53808-0889 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20140101 ANDA ANDA077068 State of Florida DOH Central Pharmacy BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 53808-0890_9b9bc863-13d3-4a5c-83ac-5dca8b28d37b 53808-0890 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140101 ANDA ANDA078040 State of Florida DOH Central Pharmacy RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 53808-0891_c8b695f2-24f9-4546-b94f-7fce9a5439dc 53808-0891 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20140101 ANDA ANDA070218 State of Florida DOH Central Pharmacy PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 53808-0892_cc71faa6-629b-4736-b8b0-5c7b971d54b7 53808-0892 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20140101 ANDA ANDA090428 State of Florida DOH Central Pharmacy LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 53808-0893_50cf8e19-72f4-4202-895f-cc9f81c2ca6f 53808-0893 HUMAN PRESCRIPTION DRUG EPIVIR HBV lamivudine TABLET, FILM COATED ORAL 20140101 NDA NDA021003 State of Florida DOH Central Pharmacy LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0894_de44300b-0179-42f7-86cd-ae9b79501222 53808-0894 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20140101 ANDA ANDA074556 State of Florida DOH Central Pharmacy ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 53808-0895_30dbb679-87a4-4823-b61b-f4b9d8078955 53808-0895 HUMAN PRESCRIPTION DRUG COMBIVIR lamivudine and zidovudine TABLET, FILM COATED ORAL 20140101 NDA NDA020857 State of Florida DOH Central Pharmacy LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0896_cc71faa6-629b-4736-b8b0-5c7b971d54b7 53808-0896 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20140101 ANDA ANDA090428 State of Florida DOH Central Pharmacy LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 53808-0898_2408db70-f2dd-40d6-8480-a420400b828f 53808-0898 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA077899 State of Florida DOH Central Pharmacy NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-0899_da42f97f-21e6-4847-9b8d-9975b6be3ccc 53808-0899 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 20140101 ANDA ANDA040161 State of Florida DOH Central Pharmacy DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 53808-0900_66c085b7-3ec3-43b4-a095-e04cf8d7a76a 53808-0900 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20090701 ANDA ANDA078512 State of Florida DOH Central Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-0902_8bc7b7df-28fe-4764-947f-a3999eafe079 53808-0902 HUMAN OTC DRUG EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140101 OTC MONOGRAPH NOT FINAL part334 State of Florida DOH Central Pharmacy DOCUSATE SODIUM 250 mg/1 E 20171231 53808-0904_d18df402-9731-472c-883c-a31ddea32289 53808-0904 HUMAN PRESCRIPTION DRUG benztropine mesylate BENZTROPINE MESYLATE TABLET ORAL 20090701 ANDA ANDA040103 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 53808-0905_19ef92d2-2d50-4b5e-ae22-7d734ca29f15 53808-0905 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20140101 NDA AUTHORIZED GENERIC NDA021160 State of Florida DOH Central Pharmacy CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 53808-0906_3b9c1dbd-4ce0-45bc-a469-a688ec2b0bae 53808-0906 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20140101 ANDA ANDA077042 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0907_db45c4b3-9d13-44dd-9b8d-b2ae6a2c4c36 53808-0907 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20140101 ANDA ANDA074253 State of Florida DOH Central Pharmacy BUSPIRONE HYDROCHLORIDE 15 mg/1 E 20171231 53808-0908_b5efba99-807d-4778-b769-e95c960a9e86 53808-0908 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA075491 State of Florida DOH Central Pharmacy BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 53808-0909_1c49c40e-091d-45ac-afdc-fbc7172c3e5c 53808-0909 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20140101 ANDA ANDA078707 State of Florida DOH Central Pharmacy RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 53808-0910_b5efba99-807d-4778-b769-e95c960a9e86 53808-0910 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA075491 State of Florida DOH Central Pharmacy BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 53808-0911_e4a7f215-ee57-4a42-9cc8-8656a08f45ea 53808-0911 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090701 ANDA ANDA074505 State of Florida DOH Central Pharmacy CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 53808-0912_e4a7f215-ee57-4a42-9cc8-8656a08f45ea 53808-0912 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090701 ANDA ANDA074505 State of Florida DOH Central Pharmacy CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 53808-0913_18def499-cbff-49a0-bdf7-dd5d38fc6f01 53808-0913 HUMAN PRESCRIPTION DRUG Carbamazepine CARBAMAZEPINE TABLET ORAL 20090701 ANDA ANDA074649 State of Florida DOH Central Pharmacy CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 53808-0914_287faa58-5c20-41cd-b83d-7c3e048b1c39 53808-0914 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET ORAL 20090701 ANDA ANDA071017 State of Florida DOH Central Pharmacy SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 53808-0915_18def499-cbff-49a0-bdf7-dd5d38fc6f01 53808-0915 HUMAN PRESCRIPTION DRUG Carbamazepine CARBAMAZEPINE TABLET ORAL 20090701 ANDA ANDA075948 State of Florida DOH Central Pharmacy CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 53808-0916_18def499-cbff-49a0-bdf7-dd5d38fc6f01 53808-0916 HUMAN PRESCRIPTION DRUG Carbamazepine CARBAMAZEPINE TABLET ORAL 20090701 ANDA ANDA074649 State of Florida DOH Central Pharmacy CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 53808-0918_bd78c370-cd5d-49c8-ab17-ff01d75067e5 53808-0918 HUMAN OTC DRUG FERROUS SULFATE IRON SUPPLEMENT TABLET ORAL 20140101 UNAPPROVED DRUG OTHER State of Florida DOH Central Pharmacy FERROUS SULFATE 325 mg/1 E 20171231 53808-0919_08a351d4-fd58-4e26-a2ee-51cb4b433cba 53808-0919 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20140101 ANDA ANDA078155 State of Florida DOH Central Pharmacy SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-0920_969c5ab2-0b80-4364-aaa1-342832e06b8f 53808-0920 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20140101 ANDA ANDA202468 State of Florida DOH Central Pharmacy MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 53808-0921_3a027eb2-61bb-411d-ad6b-8f6686a1478d 53808-0921 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20140101 ANDA ANDA078235 State of Florida DOH Central Pharmacy TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 53808-0922_9790adbf-4b4a-4ed1-8e64-bdd108059c60 53808-0922 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20140101 ANDA ANDA077032 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0923_f119023a-c0b0-4201-ad2a-3ac5ef3e2fbc 53808-0923 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075614 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 53808-0924_30f99c0e-3a3b-44a9-8a4c-89a3e88d665c 53808-0924 HUMAN PRESCRIPTION DRUG chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED ORAL 20090701 ANDA ANDA083386 State of Florida DOH Central Pharmacy CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53808-0925_30f99c0e-3a3b-44a9-8a4c-89a3e88d665c 53808-0925 HUMAN PRESCRIPTION DRUG chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED ORAL 20090701 ANDA ANDA083386 State of Florida DOH Central Pharmacy CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53808-0926_df961314-befe-4003-b46a-03f711a8b627 53808-0926 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20140101 ANDA ANDA077901 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53808-0927_5820e7c2-9380-4a58-a3e8-0651b242cdda 53808-0927 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20140101 ANDA ANDA078034 State of Florida DOH Central Pharmacy SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-0928_30f99c0e-3a3b-44a9-8a4c-89a3e88d665c 53808-0928 HUMAN PRESCRIPTION DRUG chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED ORAL 20090701 ANDA ANDA083386 State of Florida DOH Central Pharmacy CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53808-0929_3da29061-14bf-448a-bf5b-2c4b7f379482 53808-0929 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20140101 ANDA ANDA090637 State of Florida DOH Central Pharmacy ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 53808-0930_344b0ac9-7bea-4167-8b70-3a000fb50823 53808-0930 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075498 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 53808-0931_30f99c0e-3a3b-44a9-8a4c-89a3e88d665c 53808-0931 HUMAN PRESCRIPTION DRUG chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE TABLET, SUGAR COATED ORAL 20090701 ANDA ANDA083386 State of Florida DOH Central Pharmacy CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 53808-0932_b9904b22-7c79-463b-9441-709b1610a84d 53808-0932 HUMAN PRESCRIPTION DRUG Topiramate TOPIRAMATE TABLET ORAL 20090701 ANDA ANDA076575 State of Florida DOH Central Pharmacy TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 53808-0933_6ba4824d-44d7-44e8-84ab-4e87dfec5674 53808-0933 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140101 ANDA ANDA078720 State of Florida DOH Central Pharmacy AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] E 20171231 53808-0934_9228edac-c7c3-47ef-83a4-b98c7fd4b569 53808-0934 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA078281 State of Florida DOH Central Pharmacy PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 53808-0935_2debef4e-01a8-47ff-9cc7-dfa4d73152c0 53808-0935 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA090074 State of Florida DOH Central Pharmacy PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 53808-0936_9046b735-e30d-4fad-82a7-84a429ddd8eb 53808-0936 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140101 ANDA ANDA090700 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 53808-0937_d421d001-da09-424c-8440-f4b6761c1079 53808-0937 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20140101 ANDA ANDA078554 State of Florida DOH Central Pharmacy VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0938_6a4cea14-a6b0-4d95-a7cf-b14a6bdab0ce 53808-0938 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20140101 ANDA ANDA040226 State of Florida DOH Central Pharmacy PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53808-0939_790def26-67a9-4965-949a-61e6ab5dfef2 53808-0939 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140101 ANDA ANDA065229 State of Florida DOH Central Pharmacy CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 53808-0940_0a07f0df-9050-41bb-a892-f97fe0731ef7 53808-0940 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA079163 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 53808-0942_a4cec611-3775-4a0b-840d-677a7bf592df 53808-0942 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20140101 NDA AUTHORIZED GENERIC NDA020329 State of Florida DOH Central Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 53808-0943_e8963d24-7f88-43f8-9aee-4c69936c3bb8 53808-0943 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20090701 ANDA ANDA077901 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53808-0946_e3450a89-d439-4835-a9ca-fee52563bdcf 53808-0946 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20140101 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 53808-0947_e8963d24-7f88-43f8-9aee-4c69936c3bb8 53808-0947 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20090701 ANDA ANDA077901 State of Florida DOH Central Pharmacy CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 53808-0948_1d3cc383-e493-43a8-a6d7-d3995c29e670 53808-0948 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20090701 ANDA ANDA078218 State of Florida DOH Central Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 53808-0949_7431eb5a-a173-43a9-9a76-e873c59ebd12 53808-0949 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20140101 ANDA ANDA040734 State of Florida DOH Central Pharmacy METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] E 20171231 53808-0950_087ab315-05c7-408a-85ab-e972c222bf89 53808-0950 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20090701 ANDA ANDA040537 State of Florida DOH Central Pharmacy CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 E 20171231 53808-0951_0b17581a-4adf-4da1-ad3b-f15ebe08eb97 53808-0951 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20140101 NDA AUTHORIZED GENERIC NDA020702 State of Florida DOH Central Pharmacy ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-0952_5820e7c2-9380-4a58-a3e8-0651b242cdda 53808-0952 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20140101 ANDA ANDA078034 State of Florida DOH Central Pharmacy SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-0953_a35648a5-edad-466e-97cf-fc1ce7993bce 53808-0953 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 ANDA ANDA073568 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 53808-0954_2a495012-9023-4356-99db-6cfd5968cf98 53808-0954 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20140101 ANDA ANDA078626 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0956_27a1eeb9-0064-48f8-9e34-91fdb455e818 53808-0956 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20140101 ANDA ANDA040489 State of Florida DOH Central Pharmacy METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 53808-0957_13f84dd6-0543-485f-a14e-b830a4f29c2d 53808-0957 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA090797 State of Florida DOH Central Pharmacy PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 53808-0958_c6a99364-0595-4fbc-baf8-dde5513b8c34 53808-0958 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20140101 NDA NDA021402 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 53808-0959_68e4fb9f-b9e8-4411-9631-1dd26bc40975 53808-0959 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20140101 ANDA ANDA090548 State of Florida DOH Central Pharmacy ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-0960_d97aebf0-524b-4ed3-8417-38068870603d 53808-0960 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20140101 ANDA ANDA040788 State of Florida DOH Central Pharmacy HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 53808-0961_83c2dd06-d867-4af8-8f36-7f05bf243dde 53808-0961 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20140101 ANDA ANDA090510 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 53808-0962_00f6952b-d14b-462b-8881-f5aacaa44f1e 53808-0962 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20090701 ANDA ANDA062031 State of Florida DOH Central Pharmacy DOXYCYCLINE HYCLATE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 53808-0963_ce8f069a-db9a-4f98-856f-cccc4fb48d45 53808-0963 HUMAN OTC DRUG Leader Fiber Calcium polycarbophil TABLET, FILM COATED ORAL 20140101 OTC MONOGRAPH NOT FINAL part334 State of Florida DOH Central Pharmacy CALCIUM POLYCARBOPHIL 625 mg/1 E 20171231 53808-0966_23f7f4ad-800c-4d98-a604-3c45b2842841 53808-0966 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090701 ANDA ANDA075483 State of Florida DOH Central Pharmacy ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 53808-0967_ebf84f23-3beb-4480-9485-3b5f4a883943 53808-0967 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090701 ANDA ANDA090278 State of Florida DOH Central Pharmacy TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 53808-0970_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0970 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 53808-0972_ec8d1d34-d828-493d-b145-da4f4e2725ea 53808-0972 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090701 NDA NDA019152 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 53808-0976_d21388e7-ca03-4759-b7b7-046672762e8e 53808-0976 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20130101 ANDA ANDA077048 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-0977_7287877c-326f-4bf6-8dd8-3d99b6364bb6 53808-0977 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride ETHAMBUTOL HYDROCHLORIDE TABLET ORAL 20090701 NDA NDA016320 State of Florida DOH Central Pharmacy ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] E 20171231 53808-0978_eb3ec1d7-5abd-466c-b522-43d828bf787b 53808-0978 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20130101 ANDA ANDA090467 State of Florida DOH Central Pharmacy LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 53808-0979_10479dd1-9ce9-4090-a027-2e14873059da 53808-0979 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20130101 ANDA ANDA091426 State of Florida DOH Central Pharmacy SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 53808-0981_e3305dd9-e369-4db8-9274-f94fca384ea8 53808-0981 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130101 ANDA ANDA090828 State of Florida DOH Central Pharmacy SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 53808-0982_c0b718f4-95ea-4a9a-b926-4b9f16dc0714 53808-0982 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20130101 ANDA ANDA090430 State of Florida DOH Central Pharmacy THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 53808-0983_610961c9-4e0f-4e45-83d8-eb40da8a101e 53808-0983 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20130101 ANDA ANDA071251 State of Florida DOH Central Pharmacy TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 53808-0985_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0985 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 53808-0986_e45a4c59-0aa7-471a-b766-501493fd0410 53808-0986 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride TABLET ORAL 20090701 ANDA ANDA075049 State of Florida DOH Central Pharmacy FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0988_e45a4c59-0aa7-471a-b766-501493fd0410 53808-0988 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride TABLET ORAL 20090701 ANDA ANDA075049 State of Florida DOH Central Pharmacy FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-0989_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0989 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 53808-0990_a6299f1c-1ddb-4da4-a38d-2cb34eca0c02 53808-0990 HUMAN PRESCRIPTION DRUG TRIZIVIR abacavir sulfate, lamivudine, and zidovudine TABLET, FILM COATED ORAL 20130201 NDA NDA021205 State of Florida DOH Central Pharmacy ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE 300; 150; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 53808-0993_b3a5abb8-bf28-4a30-8a11-8c188a6caa57 53808-0993 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20141101 ANDA ANDA090170 State of Florida DOH Central Pharmacy LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 53808-0994_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0994 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 53808-0995_8212de09-16f4-48da-9fd4-157ea95150c2 53808-0995 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20141101 ANDA ANDA091576 State of Florida DOH Central Pharmacy MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 53808-0997_6505df44-aafe-42d9-ac5d-a517238f55ee 53808-0997 HUMAN PRESCRIPTION DRUG Warfarin Sodium WARFARIN SODIUM TABLET ORAL 20090701 ANDA ANDA040301 State of Florida DOH Central Pharmacy WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 53808-0998_3788997e-3197-4576-b1e9-3233d05d506a 53808-0998 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE TABLET ORAL 20090701 ANDA ANDA078010 State of Florida DOH Central Pharmacy FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 53808-0999_0b20f104-54f1-4197-bbdf-0cfe9304396c 53808-0999 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20141101 ANDA ANDA075994 State of Florida DOH Central Pharmacy LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 53808-1000_5112456d-2477-4ae9-9904-d7fc094d17ac 53808-1000 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20141101 ANDA ANDA075356 State of Florida DOH Central Pharmacy PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 53808-1001_9526388d-0d76-4187-acc6-2bc9c4d81b13 53808-1001 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20141101 ANDA ANDA203135 State of Florida DOH Central Pharmacy CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 53808-1002_7d66ef28-a10c-4c41-b228-ed1d6c55dfb8 53808-1002 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20141101 ANDA ANDA076273 State of Florida DOH Central Pharmacy CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 53808-1003_a59f10e6-5ec5-4351-9e2f-7b2d7d8bce25 53808-1003 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20141101 ANDA ANDA078525 State of Florida DOH Central Pharmacy LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 53808-1004_038a7bee-53d8-44c8-a83b-9c2203a6c372 53808-1004 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20141101 ANDA ANDA040756 State of Florida DOH Central Pharmacy FOLIC ACID 1 mg/1 N 20181231 53808-1006_fa8c4fad-1802-44b5-9edc-4f45659dee69 53808-1006 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20141101 NDA AUTHORIZED GENERIC NDA020405 State of Florida DOH Central Pharmacy DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 53808-1007_5381ed3f-3485-4c31-aac4-34a168296844 53808-1007 HUMAN PRESCRIPTION DRUG Pantoprazole Pantoprazole TABLET, DELAYED RELEASE ORAL 20141101 ANDA ANDA077619 State of Florida DOH Central Pharmacy PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 53808-1008_76954f50-9eb3-4b27-a0a9-13cb5f023e14 53808-1008 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20141101 ANDA ANDA091650 State of Florida DOH Central Pharmacy ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-1010_7c778d60-3b61-4b2b-9cf7-1a6b4ad3b7db 53808-1010 HUMAN PRESCRIPTION DRUG LEXIVA fosamprenavir calcium TABLET, FILM COATED ORAL 20141101 NDA NDA021548 State of Florida DOH Central Pharmacy FOSAMPRENAVIR CALCIUM 700 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],P-Glycoprotein Inducers [MoA] N 20181231 53808-1011_bf2a898c-4670-4d40-bec5-c704a5900523 53808-1011 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20141101 ANDA ANDA078947 State of Florida DOH Central Pharmacy LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 53808-1012_9d934582-4995-47b0-a368-c93be846e43b 53808-1012 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20141101 ANDA ANDA073025 State of Florida DOH Central Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-1013_e18172a7-06c3-4380-ad7f-65b93c878f2b 53808-1013 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20141101 NDA NDA021402 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 53808-1014_13e93461-6356-4a9a-8836-0d32f20d4791 53808-1014 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20141101 ANDA ANDA090168 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 53808-1015_13e93461-6356-4a9a-8836-0d32f20d4791 53808-1015 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20141101 ANDA ANDA090168 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 53808-1016_b3b5d4d8-7f43-4e58-82ef-579e71dc7457 53808-1016 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20141101 ANDA ANDA090510 State of Florida DOH Central Pharmacy HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 53808-1017_bd3008cf-9b7e-4144-88cf-2f6bb701662f 53808-1017 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20141101 ANDA ANDA076161 State of Florida DOH Central Pharmacy DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 53808-1018_b53f57c5-d13a-42c9-b385-a9b2f1af296d 53808-1018 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA078459 State of Florida DOH Central Pharmacy METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-1019_a6e393db-ad3e-4122-8e76-7b2933273784 53808-1019 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA090529 State of Florida DOH Central Pharmacy VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 53808-1020_13e93461-6356-4a9a-8836-0d32f20d4791 53808-1020 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20141101 ANDA ANDA090168 State of Florida DOH Central Pharmacy BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 53808-1021_8f31ef26-ef04-436b-bde4-819d41e1d75b 53808-1021 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20141101 ANDA ANDA078040 State of Florida DOH Central Pharmacy RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 53808-1022_8fc80443-3bea-47ce-9638-3c6d868d9a63 53808-1022 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20141101 ANDA ANDA201003 State of Florida DOH Central Pharmacy RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 53808-1023_6a4cea14-a6b0-4d95-a7cf-b14a6bdab0ce 53808-1023 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20141101 ANDA ANDA040226 State of Florida DOH Central Pharmacy PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 53808-1024_97e4a6cc-72af-453c-9ac5-fedd311870d1 53808-1024 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20141101 ANDA ANDA078384 State of Florida DOH Central Pharmacy CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 53808-1025_a1fd6d55-966f-4247-b85d-5e92f57a6a37 53808-1025 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20141101 ANDA ANDA076999 State of Florida DOH Central Pharmacy CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 53808-1026_3da29061-14bf-448a-bf5b-2c4b7f379482 53808-1026 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20141001 ANDA ANDA090637 State of Florida DOH Central Pharmacy ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 53808-1027_cb9d6b78-c046-4cc8-8d96-ed64dc2c2c2c 53808-1027 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141101 ANDA ANDA078182 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 53808-1028_67601058-9eec-4e7c-b948-942dd62a775f 53808-1028 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20141101 OTC MONOGRAPH NOT FINAL part343 State of Florida DOH Central Pharmacy ASPIRIN 325 mg/1 E 20171231 53808-1029_76ca1035-dc48-4c4d-90e3-0d1456d0e604 53808-1029 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20141101 ANDA ANDA078414 State of Florida DOH Central Pharmacy AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 53808-1030_432f511b-656e-4041-a595-c46a2e7a7b63 53808-1030 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20141101 ANDA ANDA087056 State of Florida DOH Central Pharmacy CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 E 20171231 53808-1031_f952403a-8a6c-4106-81f0-d931b214c24a 53808-1031 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel bisulphate TABLET, FILM COATED ORAL 20141101 ANDA ANDA202925 State of Florida DOH Central Pharmacy CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 53808-1032_3055d78d-d036-4288-8513-e33dc2d22ce8 53808-1032 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20141101 ANDA ANDA071839 State of Florida DOH Central Pharmacy MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 53808-1033_1bc0f8ac-bb72-460a-a74e-85eaefda2c2d 53808-1033 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20141101 ANDA ANDA091184 State of Florida DOH Central Pharmacy METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 53808-1034_9916a3b5-9e92-4248-8709-a4f0a265f39a 53808-1034 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength TABLET ORAL 20140101 OTC MONOGRAPH FINAL part343 State of Florida DOH Central Pharmacy ASPIRIN 325 mg/1 E 20171231 53808-1035_68e4fb9f-b9e8-4411-9631-1dd26bc40975 53808-1035 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20140101 ANDA ANDA090548 State of Florida DOH Central Pharmacy ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-1036_425b8fc9-64d0-435f-9e42-1fc2d19b5be3 53808-1036 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20140101 ANDA ANDA077156 State of Florida DOH Central Pharmacy BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 53808-1037_efb513f9-ec12-457e-a84f-8ad76f4fac47 53808-1037 HUMAN PRESCRIPTION DRUG Citalopram citalopram hydrobromide TABLET, FILM COATED ORAL 20140101 ANDA ANDA077046 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-1038_9790adbf-4b4a-4ed1-8e64-bdd108059c60 53808-1038 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20140101 ANDA ANDA077032 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-1039_92de62e2-6728-432e-9463-c136b381c204 53808-1039 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20140101 ANDA ANDA077563 State of Florida DOH Central Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 53808-1040_546554b9-c902-40ad-a025-ebf3534f4272 53808-1040 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20140101 ANDA ANDA040765 State of Florida DOH Central Pharmacy PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 53808-1041_2a74eb4a-6f94-4b7a-9234-8fc9339d7b6a 53808-1041 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20140101 ANDA ANDA080937 State of Florida DOH Central Pharmacy ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 53808-1042_f9e0812b-a688-4061-a457-0d0a350f457e 53808-1042 HUMAN PRESCRIPTION DRUG LEVETIRACETAM Levetiracetam TABLET, FILM COATED ORAL 20140101 ANDA ANDA090906 State of Florida DOH Central Pharmacy LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 53808-1043_eb3ec1d7-5abd-466c-b522-43d828bf787b 53808-1043 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20140101 ANDA ANDA090467 State of Florida DOH Central Pharmacy LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 53808-1044_62654411-46c6-4271-9d9d-d6716eaa5dd8 53808-1044 HUMAN PRESCRIPTION DRUG METHIMAZOLE METHIMAZOLE TABLET ORAL 20140101 ANDA ANDA202068 State of Florida DOH Central Pharmacy METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] E 20171231 53808-1045_d8347f6b-4a48-42bc-acdc-0612c4659018 53808-1045 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20140101 ANDA ANDA090200 State of Florida DOH Central Pharmacy METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 53808-1046_c344a13e-8238-4535-8661-b8752ba4893b 53808-1046 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20140101 ANDA ANDA074644 State of Florida DOH Central Pharmacy METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-1047_7e19a290-e67f-4925-8efc-30bb45d9f0d7 53808-1047 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA077058 State of Florida DOH Central Pharmacy PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 53808-1048_1c49c40e-091d-45ac-afdc-fbc7172c3e5c 53808-1048 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20140101 ANDA ANDA078707 State of Florida DOH Central Pharmacy RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 53808-1049_08a351d4-fd58-4e26-a2ee-51cb4b433cba 53808-1049 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20140101 ANDA ANDA078155 State of Florida DOH Central Pharmacy SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-1050_08a351d4-fd58-4e26-a2ee-51cb4b433cba 53808-1050 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20140101 ANDA ANDA078155 State of Florida DOH Central Pharmacy SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-1052_cd15fb45-c939-4336-b74f-02530048179b 53808-1052 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20140101 ANDA ANDA075576 State of Florida DOH Central Pharmacy OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 53808-1053_624f39af-a037-4e03-8ad0-7f05245625d4 53808-1053 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20140101 ANDA ANDA091305 State of Florida DOH Central Pharmacy NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 53808-1054_e3450a89-d439-4835-a9ca-fee52563bdcf 53808-1054 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20130101 ANDA ANDA076187 State of Florida DOH Central Pharmacy LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 53808-1055_da42f97f-21e6-4847-9b8d-9975b6be3ccc 53808-1055 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20130101 ANDA ANDA040204 State of Florida DOH Central Pharmacy DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 53808-1056_bca328b0-9205-4069-89d8-c0b577d06689 53808-1056 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20141101 ANDA ANDA075317 State of Florida DOH Central Pharmacy TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 53808-1057_a212d98c-9694-4845-ab4e-3d0a3789e810 53808-1057 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20141101 ANDA ANDA078993 State of Florida DOH Central Pharmacy LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 53808-1058_2debef4e-01a8-47ff-9cc7-dfa4d73152c0 53808-1058 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20141101 ANDA ANDA090074 State of Florida DOH Central Pharmacy PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 53808-1059_7cf06035-8974-4a9a-926b-679b5ea35dc7 53808-1059 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 20141101 ANDA ANDA062500 State of Florida DOH Central Pharmacy DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 53808-1060_2a495012-9023-4356-99db-6cfd5968cf98 53808-1060 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline TABLET, FILM COATED ORAL 20141101 ANDA ANDA078626 State of Florida DOH Central Pharmacy SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-1061_77f11b3f-cb30-432a-aa27-9c9286c91da2 53808-1061 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20141101 NDA AUTHORIZED GENERIC NDA021168 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 53808-1062_69eefde6-630a-4bee-8b98-fadde8ceaa43 53808-1062 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20141101 ANDA ANDA040901 State of Florida DOH Central Pharmacy HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 53808-1065_9a4fc6df-9de5-42e6-9c30-57be15f3c153 53808-1065 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141101 ANDA ANDA090554 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 53808-1066_4c892a60-2a09-4a71-aff4-40d881fd7de4 53808-1066 HUMAN PRESCRIPTION DRUG Amiodarone hydrochloride Amiodarone hydrochloride TABLET ORAL 20141101 ANDA ANDA079029 State of Florida DOH Central Pharmacy AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 53808-1067_76954f50-9eb3-4b27-a0a9-13cb5f023e14 53808-1067 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20141101 ANDA ANDA091650 State of Florida DOH Central Pharmacy ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 53808-1068_2902f285-bab2-4c44-a97a-ca767c5a7672 53808-1068 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA078115 State of Florida DOH Central Pharmacy CARBAMAZEPINE 400 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 53808-1069_61573dec-d862-4d5d-a2b9-59c2f1ded71f 53808-1069 HUMAN PRESCRIPTION DRUG nevirapine nevirapine TABLET ORAL 20141101 ANDA ANDA203176 State of Florida DOH Central Pharmacy NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] E 20171231 53808-1072_f59e6769-f44a-4190-a286-159a2e66c193 53808-1072 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20141101 ANDA ANDA078243 State of Florida DOH Central Pharmacy LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 53808-1073_2f7f20ff-9b15-4925-b171-7ae5ee952c07 53808-1073 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20141101 ANDA ANDA076639 State of Florida DOH Central Pharmacy CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 53808-1074_96a6937b-dc4b-4555-b544-1d1841981ca9 53808-1074 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20141101 ANDA ANDA073457 State of Florida DOH Central Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 53808-1075_e3a99ec9-c755-4445-982b-307e7887a75e 53808-1075 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20141101 ANDA ANDA071995 State of Florida DOH Central Pharmacy PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 53808-1076_1d23966b-30cf-4aaf-86ad-b9e6acf8bf03 53808-1076 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20141101 ANDA ANDA202871 State of Florida DOH Central Pharmacy METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 53808-1077_b17a0337-bae4-40ae-8fd1-40cedf4c9235 53808-1077 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20141101 ANDA ANDA077289 State of Florida DOH Central Pharmacy CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 53808-1078_5820e7c2-9380-4a58-a3e8-0651b242cdda 53808-1078 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141101 ANDA ANDA078034 State of Florida DOH Central Pharmacy SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 53808-1080_eeb807e5-b271-4c78-bfe5-c0aa720a9ed8 53808-1080 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141101 ANDA ANDA079163 State of Florida DOH Central Pharmacy DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 53808-1081_5381ed3f-3485-4c31-aac4-34a168296844 53808-1081 HUMAN PRESCRIPTION DRUG Pantoprazole Pantoprazole TABLET, DELAYED RELEASE ORAL 20141101 ANDA ANDA077619 State of Florida DOH Central Pharmacy PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 53809-203_23161838-5b4c-42c1-b8b6-653d26334fda 53809-203 HUMAN OTC DRUG DOMETUSS-DMX GUAIFENESIN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20160121 OTC MONOGRAPH FINAL part341 Domel Laboratories GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 200; 30; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 53809-204_94a8b9ce-ee01-4ea2-bccd-3d22b2fe1b9b 53809-204 HUMAN OTC DRUG DOMETUSS-NR ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL TABLET ORAL 20160121 OTC MONOGRAPH FINAL part341 Domel Laboratories ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 E 20171231 53809-205_1c9a5642-abec-42d6-af50-2735d893b423 53809-205 HUMAN OTC DRUG DOMETUSS-G ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHRPHAN HBr, PHENYLEPHRINE HCL TABLET ORAL 20160121 OTC MONOGRAPH FINAL part341 Domel Laboratories ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 100; 10; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 53809-206_17f19c1d-e930-409d-9b79-29eda77bb3ac 53809-206 HUMAN OTC DRUG DOMETUSS-DA CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20160121 OTC MONOGRAPH FINAL part341 Domel Laboratories CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL E 20171231 53817-001_c6f57819-4ac9-4c21-bb0b-86491bc96d61 53817-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850301 NDA NDA205865 Alloy Oxygen & Welding Supply Co. Inc. OXYGEN 992 mL/L N 20181231 53828-001_7d84b946-1881-41d9-a3f3-9c67e98b69e4 53828-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19350101 UNAPPROVED MEDICAL GAS Rochester Welding Supply Corp. OXYGEN 99 L/100L E 20171231 53828-006_63c30b69-4868-4214-82a1-e2868acf2db9 53828-006 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19350101 UNAPPROVED MEDICAL GAS Rochester Welding Supply Corp. NITROGEN 99 L/100L E 20171231 53835-0001_2facff60-ca7c-4cdd-9757-fef64612218e 53835-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS Heckman Healthcare Service & Supplies Inc OXYGEN 99 L/100L E 20171231 53852-0001_2ebdf02f-3bbc-4282-8928-db5a24a0c102 53852-0001 HUMAN OTC DRUG Smoke Remedy Avena sativa, Caladium seguinum, Calcarea phosphorica, Daphne indica, Eugenia jambosa, Ignatia amara, Kali phosphoricum, Nux vomica, Plantago major, Staphysagria LIQUID ORAL 20100928 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE; TRIBASIC CALCIUM PHOSPHATE; DAPHNE ODORA BARK; SYZYGIUM JAMBOS SEED; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; DELPHINIUM STAPHISAGRIA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 53852-0002_335fb129-7d23-41f6-a100-899a929da395 53852-0002 HUMAN OTC DRUG Smoke Remedy Avena sativa, Caladium seguinum, Calcarea phosphorica, Daphne indica, Eugenia jambosa, Ignatia amara, Kali phosphoricum, Nux vomica, Plantago major, Staphysagria LIQUID ORAL 20110210 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE; TRIBASIC CALCIUM PHOSPHATE; DAPHNE ODORA BARK; SYZYGIUM JAMBOS SEED; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; DELPHINIUM STAPHISAGRIA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL N 20181231 53852-0003_1ec39f75-905d-408f-93fb-bb8be6eb1857 53852-0003 HUMAN OTC DRUG Lung Remedy Phase 2 Carbo vegetabilis, Bromium, Lobelia inflata, Phosphorus, Silicea LIQUID ORAL 20121029 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC ACTIVATED CHARCOAL; BROMINE; LOBELIA INFLATA; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL N 20181231 53852-0004_f8c5330e-51aa-482a-9171-b328ce73837c 53852-0004 HUMAN OTC DRUG Lung Remedy Phase 3 Carbo vegetabilis, Bromium, Lobelia inflata, Phosphorus, Silicea LIQUID ORAL 20090714 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC ACTIVATED CHARCOAL; BROMINE; LOBELIA INFLATA; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL N 20181231 53852-0005_273680fb-11a4-4082-8f94-5bdf9ace8a8c 53852-0005 HUMAN OTC DRUG D-TOX Remedy Antimonium tartaricum, Bromium, Bryonia, Carbo vegetabilis, Carduus marianus, Echinacea purpurea, Hepar sulphuris calcareum, Kali bichromicum, Lobelia inflata, Phosphorus, Phytolacca decandra, Silicea, Solidago virgaurea, Spongia tosta, Sulphur iodatum LIQUID ORAL 20140508 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC ANTIMONY POTASSIUM TARTRATE; BROMINE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MILK THISTLE; ECHINACEA PURPUREA; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LOBELIA INFLATA; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; SULFUR IODIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL N 20181231 53852-0006_4710f9be-3441-4adf-8326-a070ecde8125 53852-0006 HUMAN OTC DRUG Weight Away Remedy kali bichromicum, calcarea carbonica, antimonium crudum, capsicum annuu, sabadilla, fucus vesiculosus, graphites, ammonium muriaticum, anacardium orientale, oleander, kali carbonicum, staphysagria, ammonium carbonicum, ferrum metallicum LIQUID ORAL 20100716 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC POTASSIUM DICHROMATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANTIMONY TRISULFIDE; CAPSICUM; SCHOENOCAULON OFFICINALE SEED; FUCUS VESICULOSUS; GRAPHITE; AMMONIUM CHLORIDE; SEMECARPUS ANACARDIUM JUICE; NERIUM OLEANDER LEAF; POTASSIUM CARBONATE; DELPHINIUM STAPHISAGRIA SEED; AMMONIUM CARBONATE; IRON 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 53852-0007_5280057c-4c84-4339-a3e9-6d38b0784372 53852-0007 HUMAN OTC DRUG Enhance Remedy For Women Agnus Castus, Aletris farinosa, Berberis vulgaris, Caulophyllum thalictroides, Causticum, Ferrum metallicum, Graphites, Ignatia amara, Natrum muriaticum, Onosmodium virginianum, Sepia LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC CHASTE TREE; ALETRIS FARINOSA ROOT; BERBERIS VULGARIS ROOT BARK; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; IRON; GRAPHITE; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; ONOSMODIUM VIRGINIANUM WHOLE; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL N 20181231 53852-0008_b46f7bcf-92b0-4293-9368-68203c4d7a31 53852-0008 HUMAN OTC DRUG FEM Remedy Amyl nitrosum, Calcarea carbonica, Cimicifuga racemosa, Ferrum metallicum, Sanguinaria canadensis, Sepia LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC AMYL NITRITE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; BLACK COHOSH; IRON; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 53852-0009_482be1cf-f0eb-4b47-b715-61cc0fb7119c 53852-0009 HUMAN OTC DRUG Sleep Now Remedy avena sativa, camphora, coffea cruda, cypripedium pubescens, ignatia amara, passiflora incarnata, valeriana officinalis LIQUID ORAL 20100716 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC AVENA SATIVA FLOWERING TOP; CAMPHOR (NATURAL); ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 53852-0010_3289cc7f-e6c0-4521-8bb2-24d3e768f006 53852-0010 HUMAN OTC DRUG Lung Remedy Phase 1 Carbo vegetabilis, Bromium, Lobelia inflata, Phosphorus, Silicea LIQUID ORAL 20121029 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC ACTIVATED CHARCOAL; BROMINE; LOBELIA INFLATA; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL N 20181231 53852-0011_f9591599-d0bd-4ce3-b7c5-34c83a97144d 53852-0011 HUMAN OTC DRUG Lung Remedy Bromium, Carbo vegetabilis, Lobelia inflata, Phosphorus, Silica LIQUID ORAL 20170508 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC BROMINE; ACTIVATED CHARCOAL; LOBELIA INFLATA; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10 [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL; [hp_C]/118mL N 20181231 53852-0012_bfd1fb52-df5d-41e3-9345-32b89c1d0d6f 53852-0012 HUMAN OTC DRUG Bone and Joint Remedy Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Equisetum hyemale, Hekla lava, Phosphorus, Silicea LIQUID ORAL 20170505 UNAPPROVED HOMEOPATHIC Living Well Remedies, LLC OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; EQUISETUM HYEMALE; HEKLA LAVA; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 53859-001_895cadd6-0d78-4adb-a66b-3ea9667cbb00 53859-001 HUMAN OTC DRUG Fresh Up Antiseptic Hand ALCOHOL SPRAY TOPICAL 20121107 OTC MONOGRAPH NOT FINAL part333E G&G Medical Products LLC ALCOHOL 70 mL/100mL N 20181231 53863-120_dd2e2774-4545-43e7-a423-4c53b97fdfbd 53863-120 HUMAN OTC DRUG Sunscreen Creme SPF 37 Exel Octocrylene,Octinoxate,Octisalate,Oxybenzone,Titanium Dioxide CREAM TOPICAL 20121015 OTC MONOGRAPH NOT FINAL part352 Exelencia Importers Corp OCTOCRYLENE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 5; 7.5; 5; 3; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 53863-122_d1c1d16d-df75-4200-bb9c-671c457f5b9d 53863-122 HUMAN OTC DRUG Sun Protection Creme SPF 30 PLUS Exel Clarifying Line Octocrylene, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20141209 OTC MONOGRAPH FINAL part352 Exelencia Importers Corp OCTOCRYLENE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 5; 7.5; 5; 3; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 53863-124_06e8b1e4-f6f1-4a7e-bad7-102dfcb2ca29 53863-124 HUMAN OTC DRUG Clarifying Line Broad Spectrum SPF 50 EXEL Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20150223 OTC MONOGRAPH FINAL part352 Exelencia importers OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 8; 3; 3 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 53863-125_ecd64dc4-d093-4784-8987-2f5c0d814d0e 53863-125 HUMAN OTC DRUG Exel Clarifying Line SPF 50 Octinoxate, Octocrylene, Oxybenzone, Tatanium Dioxide CREAM TOPICAL 20150514 OTC MONOGRAPH FINAL part352 Exelencia importers OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 8; 3; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 53877-001_50927003-7f54-4a37-b343-a1160a24f529 53877-001 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION INTRAVENOUS 20091210 NDA NDA820528 Terumo Corporation ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE 2.99; 26.3; 2.22; 31.9; .275 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 53877-001_63fee48e-dd5b-42fc-bfd3-d3d2a912fbda 53877-001 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION INTRAVENOUS 20091214 NDA BN820528 Terumo Corporation ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE 2.99; 26.3; 2.22; 31.9; .275 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 53877-001_91a0fa40-a15b-4ddd-9b36-257746df1f39 53877-001 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION INTRAVENOUS 20091118 NDA BN820528 Terumo Corporation ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE 2.99; 26.3; 2.22; 31.9; .275 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 53877-001_f23a57e7-32ed-435e-af7f-da0d25476e65 53877-001 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SOLUTION INTRAVENOUS 20120522 NDA BN820528 Terumo Corporation ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; DEXTROSE MONOHYDRATE; ADENINE 2.99; 26.3; 2.22; 31.9; .275 g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 53877-005_2fa326f5-95fe-477a-b600-e33c7038c4ab 53877-005 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100113 NDA NDA880217 Terumo Corporation N 20181231 53877-005_d86e503b-a46d-4efc-ad65-a19d1ad10306 53877-005 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20091215 NDA NDA880217 Terumo Corporation N 20181231 53877-006_d9291ddb-e940-458d-bb36-e2745b486957 53877-006 HUMAN PRESCRIPTION DRUG IMUFLEX WB-RP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Removing Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100226 NDA NDA880217 Terumo Corporation N 20181231 53877-007_a5a90c7e-c692-4131-b68e-9c48272d0538 53877-007 HUMAN PRESCRIPTION DRUG IMUFLEX WB-SP Blood Bag System with Integral Whole Blood Leukocyte Reduction Filter (Saving Platelets) with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20101215 NDA NDA880217 Terumo Corporation N 20181231 53877-008_01344968-cee8-4c49-99f3-edc437021d10 53877-008 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100505 NDA NDA880217 Terumo Corporation N 20181231 53877-008_546dbd1c-487f-4e92-a6d0-981e13b2d5f3 53877-008 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100505 NDA NDA880217 Terumo Corporation N 20181231 53877-008_5c63c208-eade-4d27-84d4-bcce7f15ed83 53877-008 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100505 NDA NDA880217 Terumo Corporation N 20181231 53877-008_bcc81a06-0371-4a3f-bf5f-10e2eec642f5 53877-008 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System with Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100505 NDA NDA880217 Terumo Corporation N 20181231 53877-009_7ea376d1-024d-4bc4-b9b7-6ff7edece570 53877-009 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System with Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100505 NDA NDA880217 Terumo Corporation N 20181231 53877-009_f08634fe-3c3b-4b52-8547-32abce4e8be8 53877-009 HUMAN PRESCRIPTION DRUG TERUFLEX Blood Bag System with Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (CPD) AND OPTISOL (AS-5) Red Cell Preservative Anticoagulant Citrate Phosphate Dextrose (CPD) AND AS-5 Red Cell Preservative KIT INTRAVENOUS 20100505 NDA NDA880217 Terumo Corporation N 20181231 53882-001_6e022f69-388e-49e9-867e-78a7e57c8ede 53882-001 HUMAN OTC DRUG Stressa Back and Neck Pain Relieving Menthol CREAM TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part348 Stressa Incorporated MENTHOL 1.25 g/100g E 20171231 53882-002_11f9d65c-4717-4802-a8d9-921d4006c9ae 53882-002 HUMAN OTC DRUG Stressa Back and Neck Pain Relieving Menthol OIL TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part348 Stressa Incorporated MENTHOL 1 g/93mL E 20171231 53897-000_60ef898e-ae56-5049-e053-2a91aa0aa14c 53897-000 HUMAN OTC DRUG Clinical Strength MiracleDry Antiperspirant Deodorant AM ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY LIQUID TOPICAL 20121015 OTC MONOGRAPH FINAL part350 Highland Consumer Products ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 18 mg/mL N 20181231 53897-001_60ef898e-ae67-5049-e053-2a91aa0aa14c 53897-001 HUMAN OTC DRUG Clinical Strength MiracleDry Antiperspirant Deodorant PM ALUMINUM CHLORIDE LIQUID TOPICAL 20121015 OTC MONOGRAPH FINAL part350 Highland Consumer Products ALUMINUM CHLORIDE 12 mg/mL N 20181231 53942-004_6c33a627-359b-4ea6-9cb3-adbeeba88575 53942-004 HUMAN OTC DRUG Anticavity Rinse Sodium Fluoride MOUTHWASH ORAL 20130508 OTC MONOGRAPH FINAL part355 Demoulas Super Markets, Inc SODIUM FLUORIDE .2 mg/mL N 20191231 53942-055_590b3a21-afe7-4395-8cb9-5a4b1147a1f7 53942-055 HUMAN OTC DRUG MARKET BASKET FRESH SCENT Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Demoulas Supermarkets, Inc. BENZALKONIUM CHLORIDE .115 g/1 N 20181231 53942-069_95fbc0fe-3191-444f-8fbd-54af8e67c5a9 53942-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19890915 OTC MONOGRAPH FINAL part347 Demoulas Supermarmkets PETROLATUM 1 g/g N 20181231 53942-072_e3b79d90-2e42-4e99-bd13-622877da84a6 53942-072 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 20070330 OTC MONOGRAPH NOT FINAL part348 Demoulas Super Markets EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 53942-080_48838146-6b40-25f9-e054-00144ff8d46c 53942-080 HUMAN OTC DRUG Menthol cough drop menthol LOZENGE ORAL 20151026 OTC MONOGRAPH FINAL part341 DeMoulas MENTHOL 5.4 mg/1 N 20181231 53942-081_4897a848-8d1f-491c-e054-00144ff8d46c 53942-081 HUMAN OTC DRUG Menthol cough drop Cherry LOZENGE ORAL 20151026 OTC MONOGRAPH FINAL part341 Demoulas MENTHOL 5.8 mg/1 N 20181231 53942-082_48a80896-b0d4-0e42-e054-00144ff8d46c 53942-082 HUMAN OTC DRUG menthol cough drop Honey Lemon LOZENGE ORAL 20151026 OTC MONOGRAPH FINAL part341 Demoulas MENTHOL 7.5 mg/1 N 20181231 53942-083_48c08709-c706-22c5-e054-00144ff8d46c 53942-083 HUMAN OTC DRUG Sugar Free Menthol cough drop Sugar Free menthol LOZENGE ORAL 20151026 OTC MONOGRAPH FINAL part341 DeMoulas MENTHOL 5.8 mg/1 N 20181231 53942-084_48fb3410-bb84-42ce-e054-00144ff88e88 53942-084 HUMAN OTC DRUG Sugar free menthol cough drop sugar free cherry LOZENGE ORAL 20151026 OTC MONOGRAPH FINAL part341 Demoulas MENTHOL 5.8 mg/1 N 20181231 53942-085_490f5cfb-71a4-6f35-e054-00144ff8d46c 53942-085 HUMAN OTC DRUG SF menthol cough drop Sugar free Honey Lemon LOZENGE ORAL 20151026 OTC MONOGRAPH FINAL part341 DeMoulas MENTHOL 7.6 mg/1 N 20181231 53942-086_60df34a1-e406-6959-e053-2a91aa0a4760 53942-086 HUMAN OTC DRUG menthol cough drops Menthol LOZENGE ORAL 20171221 OTC MONOGRAPH FINAL part341 DeMoulas MENTHOL 5.4 mg/1 N 20181231 53942-087_6209b0fd-0fd8-904b-e053-2991aa0a3359 53942-087 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20180105 OTC MONOGRAPH FINAL part341 DeMoulas MENTHOL 5.8 mg/1 N 20191231 53942-088_620bd91c-3810-6b93-e053-2a91aa0ad872 53942-088 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20180105 OTC MONOGRAPH FINAL part341 DeMoulas MENTHOL 7.5 mg/1 N 20191231 53942-089_620d4f99-cba8-5f7f-e053-2a91aa0a3000 53942-089 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20180105 OTC MONOGRAPH FINAL part341 DeMoulas MENTHOL 5.8 mg/1 N 20191231 53942-090_624aef82-c86d-4859-e053-2991aa0a767d 53942-090 HUMAN OTC DRUG Sugar Free Cherry Cough Drops Menthol LOZENGE ORAL 20180108 OTC MONOGRAPH FINAL part341 DeMoulas MENTHOL 5.8 mg/1 N 20191231 53942-091_625991ba-7d9a-59fb-e053-2a91aa0a8929 53942-091 HUMAN OTC DRUG Sugar Free Honey Lemon Cough Drops Menthol LOZENGE ORAL 20180109 OTC MONOGRAPH FINAL part341 DeMoulas MENTHOL 7.6 mg/1 N 20191231 53942-153_fdc684ca-386c-4bb4-ab6a-fe63c2dc4d79 53942-153 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Demoulas Super Markets, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 53942-163_4d14951c-d717-4365-b575-e0a4baeed051 53942-163 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20060513 OTC MONOGRAPH FINAL part355 Demoulas Super Markets, Inc. SODIUM FLUORIDE 999.5 mL/100L N 20181231 53942-210_427c19eb-33e6-4943-a48d-c2b803e0d8eb 53942-210 HUMAN OTC DRUG Advanced Antiseptic Eucalyptol MOUTHWASH ORAL 20100722 OTC MONOGRAPH FINAL part348 Demoulas Super Markets, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 53942-223_e4ab39d7-2c10-4d3a-a964-302488131faa 53942-223 HUMAN OTC DRUG Alcohol Free Antiseptic Cetylpyridiium chloride RINSE ORAL 20120416 OTC MONOGRAPH NOT FINAL part356 Demoulas Super Markets Inc CETYLPYRIDINIUM CHLORIDE .07 mL/100L N 20181231 53942-235_b96d08d2-1f81-4f15-a70d-4981fb7b4e2f 53942-235 HUMAN OTC DRUG UltraCare Alcohol Free Fresh Mint Sodium Fluoride MOUTHWASH ORAL 20150731 OTC MONOGRAPH FINAL part355 DeMoulas Market Basket SODIUM FLUORIDE .1 mg/mL N 20181231 53942-243_a6547216-54e4-441b-b4f6-1dd4a28ed25e 53942-243 HUMAN OTC DRUG Handsoap Triclosan LIQUID TOPICAL 20090112 OTC MONOGRAPH NOT FINAL part333A Demoulas Super Markets, Inc TRICLOSAN 1.545 mg/mL N 20181231 53942-281_fe768dac-7543-41c7-95e8-fa319f52d9de 53942-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090130 OTC MONOGRAPH FINAL part358H Demoulas Super Markets, Inc PYRITHIONE ZINC 1 g/100mL N 20181231 53942-299_b75b494e-b2f2-4b3d-b3e8-d6bd3f3d44be 53942-299 HUMAN OTC DRUG Antispetic Cetylpyridinium chloride LIQUID ORAL 20120221 OTC MONOGRAPH NOT FINAL part356 Demoulas Super Markets CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 53942-311_97777763-5a70-44b9-a531-e198d2719840 53942-311 HUMAN OTC DRUG Dandruff PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20090130 OTC MONOGRAPH FINAL part358H Demoulas Super Markets, Inc PYRITHIONE ZINC 1 g/100mL N 20181231 53942-318_8f3b75c6-fac0-4e71-96a3-18f486f8d011 53942-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19900715 OTC MONOGRAPH NOT FINAL part356 Demoulas Super Markets EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53942-326_5bc45b9b-b786-46dd-9525-8a7c614ef5c5 53942-326 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130601 OTC MONOGRAPH NOT FINAL part356 Demoulas Super Markets EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53942-370_8ea245ca-2a3e-4a18-8b8b-b8d316e96a7f 53942-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20151122 OTC MONOGRAPH NOT FINAL part333A Demoulas Super Markets, Inc ALCOHOL 70 mL/100mL N 20181231 53942-403_4697afee-e720-409d-bdf1-b60152d0fbe3 53942-403 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20140828 OTC MONOGRAPH NOT FINAL part333A Demoulas Super Markets, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 53942-406_1d6c4554-9e73-4fca-8ae0-8e67e14eeefd 53942-406 HUMAN OTC DRUG Market Basket Cold Sore Treatment Benzalkonium Chloride CREAM TOPICAL 20110719 OTC MONOGRAPH NOT FINAL part333A Demoulas Supermarkets, Inc. BENZALKONIUM CHLORIDE 1.3 mg/g N 20181231 53942-434_61b4abec-c6ff-40e5-8844-980f2f7c412e 53942-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20160121 OTC MONOGRAPH NOT FINAL part356 Demoulas Markets, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53942-435_abfe4391-71af-4155-afab-92d31ee4b0e8 53942-435 HUMAN OTC DRUG Glowing White Sodium fluoride MOUTHWASH ORAL 20150729 OTC MONOGRAPH FINAL part355 Demoulas Super Markets, Inc SODIUM FLUORIDE .2 mg/mL N 20181231 53942-439_9292d356-2b5a-4952-b79d-a39c4904e44f 53942-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part333A Demoulas Super Markets, Inc ALCOHOL 700 mg/mL N 20181231 53942-466_3dfccfd6-8d99-4288-b14e-b09dc7c0262d 53942-466 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Demoulas Super Markets, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 53942-501_0b587f9c-3170-4593-99cf-21b15d00c8c2 53942-501 HUMAN OTC DRUG NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20121001 OTC MONOGRAPH NOT FINAL part343 DeMoulas Market Basket ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 53942-502_ec08f963-1208-4eb0-a3e8-54165ee429bc 53942-502 HUMAN OTC DRUG NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20121001 OTC MONOGRAPH NOT FINAL part343 DeMoulas Market Basket ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 53942-503_fa73f271-24b8-446b-bbb8-bf27adc3da07 53942-503 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20121001 OTC MONOGRAPH FINAL part341 DeMoulas Market Basket DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 53942-504_82bcc421-1ce2-485f-bb87-3ff242b825c0 53942-504 HUMAN OTC DRUG Tussin CF Multi-Symptom Cold DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120920 OTC MONOGRAPH FINAL part341 DeMoulas Market Basket DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 53942-505_6729fdc3-b690-4fd6-bc92-086b3665eabd 53942-505 HUMAN OTC DRUG Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20120911 OTC MONOGRAPH FINAL part336 DeMoulas Market Basket DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 53942-506_4306d2f7-0d57-46f9-ab7d-4d926dc1ef44 53942-506 HUMAN OTC DRUG DAY-TIME Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120912 OTC MONOGRAPH NOT FINAL part343 DeMoulas Market Basket ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 53942-515_f4006130-49c2-4736-9587-049a8128fa6e 53942-515 HUMAN OTC DRUG Cold and Sinus Maxium Strength ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20130919 OTC MONOGRAPH FINAL part341 DeMoulas Market Basket ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 53942-516_b56a5d3a-3879-430c-840e-f20457d961c3 53942-516 HUMAN OTC DRUG Cold, Flu and Sore Throat Maxium Strength ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20130919 OTC MONOGRAPH FINAL part341 DeMoulas Market Basket ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 53942-519_21d4f2ca-423a-4cf2-ae6f-31a45e7bcaf9 53942-519 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20100901 OTC MONOGRAPH FINAL part347 Demoulas Supermarkets, Inc PETROLATUM 1000 mg/100g N 20181231 53942-522_8564806a-c828-4550-b9b7-166fd7a289ba 53942-522 HUMAN OTC DRUG Nighttime Sleep-Aid DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20130919 OTC MONOGRAPH FINAL part338 DeMoulas Market Basket DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 53942-641_1a32c430-864a-4b66-aed3-9bca14217055 53942-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Demoulas Super Markets, Inc BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 53942-664_fec61794-8a85-4282-819c-73077cacff18 53942-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19980315 OTC MONOGRAPH NOT FINAL part356 Demoulas Super Markets, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53942-871_b6645a8c-504d-4920-8764-16f4b017669d 53942-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Demoulas Super Markets, Inc HYDROGEN PEROXIDE .3 kg/100L N 20181231 53943-001_d811db84-0522-4c85-8947-2ace49cbaf3c 53943-001 HUMAN OTC DRUG DISCOUNT DRUG MART WITCH HAZEL WITCH HAZEL LIQUID TOPICAL 20150415 OTC MONOGRAPH FINAL part347 DISCOUNT DRUG MART WITCH HAZEL 300 mg/mL N 20181231 53943-002_c2fb98ab-5f66-41ae-9802-bb33412ed351 53943-002 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20171219 OTC MONOGRAPH FINAL part358F Discount Drug Mart SALICYLIC ACID 40 mg/91 N 20181231 53943-003_38ddaf20-d876-4878-aeac-4290d9e0979e 53943-003 HUMAN OTC DRUG Lidocaine Burn Relief AEROSOL, SPRAY TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart LIDOCAINE .64 g/127g N 20181231 53943-004_58fde267-abaf-46e3-bd5a-8f70167d7067 53943-004 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20171219 OTC MONOGRAPH FINAL part358F Discount Drug Mart SALICYLIC ACID 40 mg/41 N 20181231 53943-005_4f7090c1-d38c-4106-90cc-85ee49e59fd0 53943-005 HUMAN OTC DRUG Discount Drug Mart Enema Sodium Phosphate Enema ENEMA RECTAL 20131227 OTC MONOGRAPH NOT FINAL part334 DISCOUNT DRUG MART, INC. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 53943-006_4577dd9b-66dd-dd89-9024-b2bd55d8f679 53943-006 HUMAN OTC DRUG Allergy Relief Fluticasone Propionate SPRAY, METERED NASAL 20170703 ANDA ANDA208150 Discount Drug Mart FLUTICASONE PROPIONATE 50 ug/1 N 20181231 53943-007_5f80de89-e746-4328-9ba7-13837a06040a 53943-007 HUMAN OTC DRUG Tolnafate Foot Odor Control Spray AEROSOL, POWDER TOPICAL 20171219 OTC MONOGRAPH FINAL part333C Discount Drug Mart TOLNAFTATE 1.3 g/113g N 20181231 53943-008_a32684fd-4916-443d-9c51-e3501c18a149 53943-008 HUMAN OTC DRUG Miconazole Nitrate Miconazorb AF Powder POWDER TOPICAL 20171219 OTC MONOGRAPH FINAL part333C Discount Drug Mart MICONAZOLE NITRATE 1.42 g/71g N 20181231 53943-009_6295f894-4a2f-496b-ba1c-7bb0023fc8fc 53943-009 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid LIQUID TOPICAL 20171219 OTC MONOGRAPH FINAL part358B Discount Drug Mart SALICYLIC ACID .17 mg/9mL N 20181231 53943-010_883edb1e-45ff-4755-9ae7-d7466a9083e0 53943-010 HUMAN OTC DRUG Magesium Citrate Magesium Citrate LIQUID ORAL 20120827 OTC MONOGRAPH NOT FINAL part334 DISCOUNT DRUG MART, INC MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 53943-011_4939ff45-7b0e-3805-e054-00144ff8d46c 53943-011 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20151020 OTC MONOGRAPH FINAL part341 Discount Drug Mart MENTHOL 5.4 mg/1 N 20181231 53943-012_4947a7be-1cb2-6ed0-e054-00144ff8d46c 53943-012 HUMAN OTC DRUG Menthol cough drop Cherry menthol LOZENGE ORAL 20151020 OTC MONOGRAPH FINAL part341 Discount Drug Mart MENTHOL 5.8 mg/1 N 20181231 53943-013_4984f792-f42c-1059-e054-00144ff8d46c 53943-013 HUMAN OTC DRUG Menthol Cough drop Honey lemon menthol LOZENGE ORAL 20151020 OTC MONOGRAPH FINAL part341 Discount Drug Mart MENTHOL 7.5 mg/1 N 20181231 53943-014_49985369-dfb8-66b0-e054-00144ff8d46c 53943-014 HUMAN OTC DRUG Sugar free menthol cough drop Sugar free cherry LOZENGE ORAL 20120823 OTC MONOGRAPH FINAL part341 Discount Drug Mart MENTHOL 5.8 mg/1 N 20181231 53943-015_49ae03c6-6d21-39aa-e054-00144ff88e88 53943-015 HUMAN OTC DRUG Sugar Free menthol cough drop Sugar free Honey lemon LOZENGE ORAL 20120823 OTC MONOGRAPH FINAL part341 Discount Drug Mart MENTHOL 7.6 mg/1 N 20181231 53943-019_80171ba2-4797-4d3d-8ec5-1d15eccb1234 53943-019 HUMAN OTC DRUG Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20150424 OTC MONOGRAPH NOT FINAL part343 DISCOUNT DRUG MART ACETAMINOPHEN 160 mg/5mL N 20181231 53943-020_81685acc-fc05-4f71-a96e-725b74653ca2 53943-020 HUMAN OTC DRUG Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20150424 OTC MONOGRAPH NOT FINAL part343 DISCOUNT DRUG MART ACETAMINOPHEN 160 mg/5mL N 20181231 53943-021_ab09fd7c-b1a7-4bf9-9f86-801331a6588e 53943-021 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20150506 ANDA ANDA202039 Discount Drug Mart FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 53943-023_e5e2af31-fc99-4f89-a632-dbb316ceba4a 53943-023 HUMAN OTC DRUG Tussin Peak Cold sugar-free COUGH PLUS CHEST CONGESTION DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150421 OTC MONOGRAPH FINAL part341 DISCOUNT DRUG MART DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 53943-024_e85c204f-2be9-4650-95d6-65ba5e89f915 53943-024 HUMAN OTC DRUG Extra Strength Pain Relief PM Acetaminophen 500mg Diphenhydramine HCl 25mg TABLET, COATED ORAL 20130620 OTC MONOGRAPH NOT FINAL part343 Discount Drug Mart ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 53943-025_b20fd9cc-27ef-4a83-bbdd-8affafd8687f 53943-025 HUMAN OTC DRUG Adult Extra Strength Pain Relief acetaminophen LIQUID ORAL 20150507 OTC MONOGRAPH NOT FINAL part343 DISCOUNT DRUG MART ACETAMINOPHEN 500 mg/15mL N 20181231 53943-027_ebedd4cb-b201-450b-86c4-b845706d7865 53943-027 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride SOLUTION ORAL 20160211 OTC MONOGRAPH FINAL part341 DISCOUNT DRUG MART DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/20mL N 20181231 53943-028_479c1223-bffd-443a-923f-052adf1b0a2b 53943-028 HUMAN OTC DRUG Pain Relief PM acetaminophen, diphenhydramine hydrochloride LIQUID ORAL 20160223 OTC MONOGRAPH NOT FINAL part343 DISCOUNT DRUG MART ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/15mL; mg/15mL N 20181231 53943-030_cd1b4fb5-18ca-435f-88ee-2e7a71dc3dd3 53943-030 HUMAN OTC DRUG Diphenhydramine HCl and Zinc Acetate Extra Strength Itch Relief SPRAY TOPICAL 20130325 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.52; .076 g/76g; g/76g N 20181231 53943-046_34a0e427-a62b-5664-e054-00144ff88e88 53943-046 HUMAN OTC DRUG Allergy Relief CHLORPHENIRAMINE MALEATE TABLET, COATED ORAL 20140519 OTC MONOGRAPH FINAL part341 Discount Drug Mart CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 53943-070_c78db230-e542-4c8b-9297-ad0130b7bbdf 53943-070 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20171102 OTC MONOGRAPH NOT FINAL part333A Discount Drug Mart ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 53943-090_3cdf1975-260d-14f5-e054-00144ff8d46c 53943-090 HUMAN OTC DRUG Allergy DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20160930 OTC MONOGRAPH FINAL part341 Discount Drug Mart DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 53943-091_6f12423a-11d1-405d-9bd5-137fce98717b 53943-091 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20171107 OTC MONOGRAPH NOT FINAL part333A Discount Drug Mart ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 53943-098_5d565cbc-873c-41dc-e053-2991aa0a6787 53943-098 HUMAN OTC DRUG DDM Ear Drops for Swimmers Isopropyl Alcohol LIQUID AURICULAR (OTIC) 20080101 OTC MONOGRAPH FINAL part344 Discount Drug Mart ISOPROPYL ALCOHOL 950 mg/mL N 20181231 53943-099_15c5eaf2-8b1d-48f0-8cbe-397ee8d1cb72 53943-099 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20171024 OTC MONOGRAPH NOT FINAL part333A Discount Drug Mart HYDROGEN PEROXIDE 3 mL/100mL N 20181231 53943-105_5d56b006-48d5-cc50-e053-2991aa0a28f0 53943-105 HUMAN OTC DRUG DDM Instant Antiseptic Pain Relief Camphor 10.8% and Phenol 4.7% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart CAMPHOR (NATURAL); PHENOL 108; 47 mg/mL; mg/mL N 20181231 53943-114_0795d1c0-57ec-4892-850e-56ea7f431112 53943-114 HUMAN OTC DRUG DISCOUNT DRUG MART ANTIBACTERIAL FOAMING FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140529 OTC MONOGRAPH NOT FINAL part333E DISCOUNT DRUG MART BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 53943-114_a0718b4f-ff7b-415d-a2d5-ed0ec92df963 53943-114 HUMAN OTC DRUG DISCOUNT DRUG MART ANTIBACTERIAL FOAMING FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140529 OTC MONOGRAPH NOT FINAL part333E DISCOUNT DRUG MART BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 53943-114_b527ec33-416d-4304-9a3d-405ffd080a71 53943-114 HUMAN OTC DRUG Discount Drug Mart Antibacterial Foaming Fresh Water Benzalkonium Chloride LIQUID TOPICAL 20170509 OTC MONOGRAPH NOT FINAL part333E Discount Drug Mart BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 53943-115_f5312ee8-5fef-4c62-af83-0f8ef81bdd53 53943-115 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20130620 ANDA ANDA091237 Discount Drug Mart IBUPROFEN 200 mg/1 N 20181231 53943-207_5d571a86-5976-cdbd-e053-2991aa0acbf0 53943-207 HUMAN OTC DRUG DDM Decolorized Iodine Ethyl Alcohol LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Discount Drug Mart ALCOHOL .45 mL/mL N 20181231 53943-210_9fb60617-2293-43a9-bd59-3ea943549d81 53943-210 HUMAN OTC DRUG Advanced Antiseptic Citrus EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 19910615 OTC MONOGRAPH NOT FINAL part356 Drug Mart EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .042 mL/100L; mL/100L; mL/100L; mL/100L N 20181231 53943-213_5d539dfd-9d59-c162-e053-2991aa0a51c0 53943-213 HUMAN OTC DRUG DDM Iodine Tincture Mild Iodine and Sodium Iodide and Alcohol LIQUID TOPICAL 19790101 OTC MONOGRAPH NOT FINAL part333A Discount Drug Mart IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 53943-240_4e162470-a368-7422-e054-00144ff88e88 53943-240 HUMAN OTC DRUG Lubricant Eye Drops Ultra polyethylene glycol, propylene glycol LIQUID OPHTHALMIC 20161111 OTC MONOGRAPH FINAL part349 Discount Drug Mart POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 53943-253_480b334d-c213-0045-e054-00144ff88e88 53943-253 HUMAN OTC DRUG Discount Drug Mart Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20101028 OTC MONOGRAPH FINAL part358G Discount Drug Mart PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 53943-325_5d161a9d-0463-0afd-e053-2991aa0a22e2 53943-325 HUMAN OTC DRUG DDM Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Discount Drug Mart POVIDONE-IODINE 100 mg/mL N 20181231 53943-370_581ba4e5-c305-40bf-a42c-7d4ad371595f 53943-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20120921 OTC MONOGRAPH NOT FINAL part333A Drug Mart ALCOHOL 70 mL/100mL N 20181231 53943-400_5d536077-b5ba-29b8-e053-2a91aa0a9ae1 53943-400 HUMAN OTC DRUG DDM Calaclear Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Discount Drug Mart ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 53943-401_a1e34918-1d74-4eff-a680-80bde3243007 53943-401 HUMAN OTC DRUG IBUPROFEN IMMEDIATE RELEASE IBUPROFEN TABLET, COATED ORAL 20141222 ANDA ANDA079129 Discount Drug Mart IBUPROFEN 200 mg/1 N 20181231 53943-403_baf329a1-cef9-445e-8a16-26976e22f4cc 53943-403 HUMAN OTC DRUG IBUPROFEN IMMEDIATE RELEASE IBUPROFEN TABLET, COATED ORAL 20141222 ANDA ANDA079129 Discount Drug Mart IBUPROFEN 200 mg/1 N 20181231 53943-413_5d53685b-ca3f-35c1-e053-2a91aa0aff6e 53943-413 HUMAN OTC DRUG DDM Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 Discount Drug Mart ZINC OXIDE 160 mg/mL N 20181231 53943-420_5d537a11-0492-0a8d-e053-2a91aa0aa0c3 53943-420 HUMAN OTC DRUG DDM Calagesic Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Discount Drug Mart ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 53943-439_bede80ff-0880-4cfe-8adc-9376b73bdd7f 53943-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120921 OTC MONOGRAPH NOT FINAL part333A Discount Drug Mart, Inc ALCOHOL 700 mg/mL N 20181231 53943-467_5d56cbe6-4e3a-79eb-e053-2a91aa0a74d3 53943-467 HUMAN OTC DRUG DDM Camphor Spirit Camphor 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart CAMPHOR (NATURAL) 100 mg/mL N 20181231 53943-500_c85161eb-0f36-cfa6-7688-02fcb45437eb 53943-500 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160830 ANDA ANDA208150 Discount Drug Mart FLUTICASONE PROPIONATE 50 ug/1 N 20181231 53943-501_9f4d145d-8d87-474a-a9d5-41c17ee51f9a 53943-501 HUMAN OTC DRUG Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20141021 OTC MONOGRAPH FINAL part341 Discount Drug Mart ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL E 20171231 53943-502_93c53e38-ad54-4f0b-83b1-555975eafba1 53943-502 HUMAN OTC DRUG Night-Time Multi-Symptom Cold/Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20141119 OTC MONOGRAPH FINAL part341 Discount Drug Mart ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL E 20171231 53943-503_11e503ec-be2f-43ab-8788-c6a48b46203e 53943-503 HUMAN OTC DRUG Tussin DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20141119 OTC MONOGRAPH FINAL part341 Discount Drug Mart DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 53943-504_0b99adc8-1b02-4ba7-b7ea-ca9c4bf767ba 53943-504 HUMAN OTC DRUG Tussin CF DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20141119 OTC MONOGRAPH FINAL part341 Discount Drug Mart DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 53943-505_b4b5722d-8156-45bd-941d-06eea16fda19 53943-505 HUMAN OTC DRUG CHILDRENS ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20150112 OTC MONOGRAPH FINAL part341 Discount Drug Mart DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 53943-506_420dc118-5d2c-4b46-bdca-a2ca9b0745ed 53943-506 HUMAN OTC DRUG Day-Time NON-DROWSY COLD/FLU RELIEF ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL LIQUID ORAL 20141025 OTC MONOGRAPH FINAL part341 Discount Drug Mart ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL E 20171231 53943-507_e00f4e16-ed26-4ab9-bb04-ab97ac8c3399 53943-507 HUMAN OTC DRUG Tussin GUAIFENESIN LIQUID ORAL 20141119 OTC MONOGRAPH FINAL part341 Discount Drug Mart GUAIFENESIN 100 mg/5mL E 20171231 53943-508_f03438a7-97ff-4f60-a7e6-b49ad6db6a55 53943-508 HUMAN OTC DRUG Night-Time COUGH RELIEF DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20141027 OTC MONOGRAPH FINAL part341 Discount Drug Mart DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL E 20171231 53943-511_ca3eeafd-13ee-42e0-9e68-25d0f098aa55 53943-511 HUMAN OTC DRUG Childrens Chest Congestion Relief Grape GUAIFENESIN LIQUID ORAL 20150204 OTC MONOGRAPH FINAL part341 Discount Drug Mart GUAIFENESIN 100 mg/5mL E 20171231 53943-512_00ad9401-ec65-49a2-a878-620552154d87 53943-512 HUMAN OTC DRUG Childrens Cough Mucus Relief DEXTROMETHORPHANN Hbr, GUAIFENESIN LIQUID ORAL 20160804 OTC MONOGRAPH FINAL part341 Discount Drug Mart DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 53943-515_5d1583fa-968b-5987-e053-2991aa0a0d60 53943-515 HUMAN OTC DRUG DDM Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 Discount Drug Mart CASTOR OIL 1 mg/mL N 20181231 53943-517_60b3ebdf-c922-4898-97f9-43e790ce6764 53943-517 HUMAN OTC DRUG MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20131210 OTC MONOGRAPH FINAL part341 Discount Drug Mart DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL E 20171231 53943-518_98c4e804-807a-4f0f-914e-9beed5d35b9a 53943-518 HUMAN OTC DRUG MAXIUM STRENGTH DM MAX DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20131210 OTC MONOGRAPH FINAL part341 Discount Drug Mart DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL E 20171231 53943-521_1820f7e3-cd7e-4aef-a8f0-4cc57251d72a 53943-521 HUMAN OTC DRUG Cold and Chest Congestion Relief ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE LIQUID ORAL 20160804 OTC MONOGRAPH FINAL part341 Discount Drug Mart ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN 325; 5; 200 mg/15mL; mg/15mL; mg/15mL N 20181231 53943-522_eb4ebcfb-8b9b-42d9-91e4-78d6052a5093 53943-522 HUMAN OTC DRUG NIGHT TIME SLEEP-AID DIPHENHYDRAMINE HCL LIQUID ORAL 20131210 OTC MONOGRAPH FINAL part338 Discount Drug Mart DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL E 20171231 53943-525_4b7ec3b1-df40-480b-a5ca-000947a960a7 53943-525 HUMAN OTC DRUG Childrens Pain and Fever ACETAMINOPHEN LIQUID ORAL 20150403 OTC MONOGRAPH NOT FINAL part343 Discount Drug Mart ACETAMINOPHEN 160 mg/5mL E 20171231 53943-526_ee7ee5f4-8866-4126-bbff-ca673a0e5f7e 53943-526 HUMAN OTC DRUG Childrens Pain and Fever ACETAMINOPHEN LIQUID ORAL 20160804 OTC MONOGRAPH NOT FINAL part343 Discount Drug Mart ACETAMINOPHEN 160 mg/5mL N 20181231 53943-534_9c8d052d-0dd7-477a-8d67-e4bac14bee90 53943-534 HUMAN OTC DRUG Night Time Severe Cold and Cough Relief ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL LIQUID ORAL 20160804 OTC MONOGRAPH FINAL part341 Discount Drug Mart ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 53943-553_cce3608a-9eaf-4d3f-9ddf-ba46189a80b1 53943-553 HUMAN OTC DRUG DISCOUNT DRUG MART MINT MOUTHWASH CETYLPYRIDINIUM CHLORIDE LIQUID ORAL 20140506 OTC MONOGRAPH NOT FINAL part356 DISCOUNT DRUG MART CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 53943-554_85c170c2-92bf-43e8-854d-8ef80d18cdd6 53943-554 HUMAN OTC DRUG DISCOUNT DRUG MART ANTICAVITY FLUORIDE RINSE MINT FLAVOR SODIUM FLUORIDE LIQUID ORAL 20140515 OTC MONOGRAPH FINAL part355 DISCOUNT DRUG MART SODIUM FLUORIDE .5 mg/mL N 20181231 53943-556_eca41ad5-7d3c-4494-910f-ce0828e20a21 53943-556 HUMAN OTC DRUG DISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140506 OTC MONOGRAPH NOT FINAL part356 DISCOUNT DRUG MART EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53943-557_7c264e6b-f8f1-4d84-81b4-b38571ee2bc0 53943-557 HUMAN OTC DRUG DISCOUNT DRUG MART BLUE MINT MOUTHWASH EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140506 OTC MONOGRAPH NOT FINAL part356 DISCOUNT DOLLAR MART EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53943-558_aae6ed14-9cc0-43a3-a399-87206ec32a6d 53943-558 HUMAN OTC DRUG DISCOUNT DRUG MART SPRING MINT MOUTHWASH EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140506 OTC MONOGRAPH NOT FINAL part356 DISCOUNT DRUG MART EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 53943-602_71849628-56a4-4fa7-9bf5-8ea3f2a71b7a 53943-602 HUMAN OTC DRUG Epsom Salt Magnesium sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20021202 OTC MONOGRAPH NOT FINAL part334 Discount Drug Mart MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 53943-721_6e50a43e-bc72-4540-8c9b-908d01459885 53943-721 HUMAN OTC DRUG DISCOUNT DRUG MART ANTIBACTERIAL CLEAN AND FRESH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140529 OTC MONOGRAPH NOT FINAL part333E DISCOUNT DRUG MART BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 53943-721_e1755c6c-9000-46d1-8521-154b4a9c29da 53943-721 HUMAN OTC DRUG DISCOUNT DRUG MART ANTIBACTERIAL CLEAN AND FRESH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140529 OTC MONOGRAPH NOT FINAL part333E DISCOUNT DRUG MART BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 53943-749_5d56f88a-d8b7-3926-e053-2a91aa0a3ce9 53943-749 HUMAN OTC DRUG DDM Merthiolate Benzalkonium Chloride LIQUID TOPICAL 20171026 OTC MONOGRAPH NOT FINAL part333A Discount Drug Mart BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 53943-804_6e4145dc-85a2-4846-90a4-19e004cc0bfc 53943-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20101130 OTC MONOGRAPH NOT FINAL part333A Discount Drug Mart ISOPROPYL ALCOHOL .91 mg/mL N 20181231 53943-826_b6b4be18-2e6e-42c1-8087-de836c8721c1 53943-826 HUMAN OTC DRUG less drowsy motion sickness relief Meclizine Hydrochloride TABLET ORAL 20141201 OTC MONOGRAPH FINAL part336 Discount Drug Mart MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 53943-835_0c7435fe-5486-4e7b-af20-a961cff1416f 53943-835 HUMAN OTC DRUG DISCOUNT drug mart FOOD FAIR earwax removal kit CARBAMIDE PEROXIDE SOLUTION TOPICAL 20141127 OTC MONOGRAPH FINAL part344 Discount Drug Mart CARBAMIDE PEROXIDE 65 mg/mL N 20181231 53943-836_c55b8f9d-1396-43c0-acc9-5e3485eadb07 53943-836 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20170913 OTC MONOGRAPH NOT FINAL part343 DISCOUNT DRUG MART ACETAMINOPHEN 160 mg/1 N 20181231 53943-837_775519ad-5683-451f-9bfc-5fafc70c68ec 53943-837 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20170913 OTC MONOGRAPH NOT FINAL part343 DISCOUNT DRUG MART ACETAMINOPHEN 160 mg/1 N 20181231 53943-871_99c6c103-d96a-4605-b521-026e5f698458 53943-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part333A Discount Drug Mart HYDROGEN PEROXIDE 30 mg/mL N 20181231 53943-890_9d955fe8-c7ed-44eb-9a1f-5433095493d3 53943-890 HUMAN OTC DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20171016 ANDA ANDA209339 DISCOUNT DRUG MART ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg/1 N 20181231 53943-904_e63d29b9-8974-48ed-80a5-b6c945a73fa6 53943-904 HUMAN OTC DRUG 2-Count HEAT PATCHES CAPSAICIN PATCH TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart, Inc CAPSAICIN .025 g/100g N 20181231 53943-907_3f416a55-766e-4ca8-af34-17c74a941b07 53943-907 HUMAN OTC DRUG Medicated Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart, Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 6; 10 g/100g; g/100g; g/100g N 20181231 53943-911_14b54943-dc3e-42bc-9a4b-a1a13deda81c 53943-911 HUMAN OTC DRUG DISCOUNT DRUG MART PAIN RELIEF PATCHES LIDOCAINE PATCH TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart, Inc LIDOCAINE 4 g/100g N 20181231 53943-983_24259fe5-c701-17e0-e054-00144ff88e88 53943-983 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20151109 OTC MONOGRAPH FINAL part333B Discount Drug Mart, Inc. BACITRACIN ZINC 500 [USP'U]/g E 20171231 53943-984_615975c5-6ea3-13ea-e053-2991aa0a06e1 53943-984 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20151030 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart, Inc. HYDROCORTISONE 1 g/100g N 20181231 53943-985_6159dff2-b8a2-492d-e053-2991aa0ab4d1 53943-985 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20151030 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart Inc. HYDROCORTISONE 10 mg/g N 20181231 53943-986_61594818-2226-4043-e053-2991aa0a2681 53943-986 HUMAN OTC DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart, Inc. HYDROCORTISONE 10 mg/g N 20181231 53943-987_6159cceb-d870-2dcf-e053-2991aa0a2934 53943-987 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20120801 OTC MONOGRAPH FINAL part333B Discount Drug Mart, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 53943-988_56fed82c-69c6-2547-e054-00144ff88e88 53943-988 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20151030 OTC MONOGRAPH FINAL part333B Discount Drug Mart, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 53943-989_615a0727-c569-7f5a-e053-2a91aa0a5fcf 53943-989 HUMAN OTC DRUG Hemorrhoidal Mineral oil Petrolatum Phenylephrine HCl OINTMENT TOPICAL 20151109 OTC MONOGRAPH FINAL part346 Discount Drug Mart Inc. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 53943-990_5514ff4c-c64b-0bbd-e054-00144ff8d46c 53943-990 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20151109 OTC MONOGRAPH FINAL part333C Discount Drug Mart, Inc. CLOTRIMAZOLE 1 g/100g N 20181231 53943-991_2425da91-75ed-5f8f-e054-00144ff8d46c 53943-991 HUMAN OTC DRUG Muscle and Joint Pain Relief MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20151109 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart, Inc. MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g E 20171231 53943-992_615a1916-b000-4287-e053-2a91aa0a739e 53943-992 HUMAN OTC DRUG Pain Relief Rub Camphor,Menthol, methyl salicylate CREAM TOPICAL 20151109 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart, Inc. MENTHOL; MENTHYL SALICYLATE, (+/-)-; CAMPHOR (NATURAL) 10; 30; 4 g/100g; g/100g; g/100g N 20181231 53943-993_235d6ccf-a14e-5ea8-e054-00144ff88e88 53943-993 HUMAN OTC DRUG Muscle and Joint Menthol GEL TOPICAL 20151030 OTC MONOGRAPH NOT FINAL part348 Discount Drug Mart, Inc. MENTHOL 2.5 g/100g E 20171231 53943-994_615e314b-1201-4a88-e053-2a91aa0a8cb4 53943-994 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20151109 OTC MONOGRAPH FINAL part333C Discount Drug Mart, Inc. TOLNAFTATE 1 g/100g N 20181231 53943-995_23c24f05-8c4e-37ab-e054-00144ff88e88 53943-995 HUMAN OTC DRUG Vaporizing Chest Rub Camphor, Eucalyptus Oil, Menthol GEL TOPICAL 20151104 OTC MONOGRAPH FINAL part341 Discount Drug Mart Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 2.6; 1.2 g/100g; g/100g; g/100g N 20181231 53943-996_615a4857-a67b-2852-e053-2a91aa0a53ca 53943-996 HUMAN OTC DRUG Oral Pain Relief Oral Pain Reliever GEL TOPICAL 20151109 OTC MONOGRAPH NOT FINAL part356 Discount Drug Mart, Inc. BENZOCAINE 200 mg/g N 20181231 53943-997_6a6cbd5f-8b64-4f72-b5c8-8f3dad7283fc 53943-997 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide LIQUID ORAL 20160128 OTC MONOGRAPH NOT FINAL part334 DISCOUNT DRUG MART MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 53943-998_fbb8d737-d9e3-4654-8ffc-12b85f8202b1 53943-998 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide LIQUID ORAL 20160128 OTC MONOGRAPH NOT FINAL part334 DISCOUNT DRUG MART MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 53943-999_c5de87a7-1d2f-4eae-8667-5a8f1c3d1192 53943-999 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide LIQUID ORAL 20160128 OTC MONOGRAPH NOT FINAL part334 DISCOUNT DRUG MART MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 53950-7007_447135e8-5d2a-4d28-b629-b2d52e2f2c59 53950-7007 HUMAN OTC DRUG Robanda Anti-Aging Hand Avobenzone, Octinoxate, Octisilate and Oxybenzone LOTION TOPICAL 20121102 OTC MONOGRAPH NOT FINAL part352 Robanda International, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 1; 7.5; 5; 6 mg/100mL; mg/100mL; mg/100mL; mg/100mL E 20171231 53964-001_4f4fe702-275a-24c3-e054-00144ff88e88 53964-001 HUMAN PRESCRIPTION DRUG TEPADINA THIOTEPA INJECTION, POWDER, FOR SOLUTION INTRACAVITARY; INTRAVENOUS; INTRAVESICAL 20170126 NDA NDA208264 ADIENNE SA THIOTEPA 15 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 53964-002_4f4fe702-275a-24c3-e054-00144ff88e88 53964-002 HUMAN PRESCRIPTION DRUG TEPADINA THIOTEPA INJECTION, POWDER, FOR SOLUTION INTRACAVITARY; INTRAVENOUS; INTRAVESICAL 20170126 NDA NDA208264 ADIENNE SA THIOTEPA 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 53975-001_13a4cd05-6204-4c20-a791-5143b5c756c6 53975-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20130101 NDA NDA205865 Fielden Gas Products, Inc. OXYGEN 99 L/100L N 20181231 53991-001_b3bb6bb6-7123-41af-94e7-97c63412b4aa 53991-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20121024 NDA NDA205767 Southern Gas and Supply of Mississippi, Inc. OXYGEN 995 mL/L N 20181231 53997-100_7368031e-8bdc-4e44-bd74-87b28bcd04e3 53997-100 HUMAN OTC DRUG LANSINOH BABY DIMETHICONE OINTMENT TOPICAL 20110101 OTC MONOGRAPH FINAL part347 Lansinoh Laboratories, Inc. DIMETHICONE; LANOLIN; ZINC OXIDE 4.25; 13.17; 4.675 g/85g; g/85g; g/85g E 20171231 54005-0001_d542d521-8269-4915-b152-0cd8fbed6690 54005-0001 HUMAN OTC DRUG GRAVI-T Allium Sativum, Althaea Officinalis, Annona Muricata, Capsicum Annum, Carduus Marianus, Curcuma Longa, Decaffeinated Camellia Sinensis LIQUID ORAL 20130806 UNAPPROVED HOMEOPATHIC Infinite Therapies of Sarasota, Inc. GARLIC; ALTHAEA OFFICINALIS ROOT; SOURSOP; CAPSICUM; SILYBUM MARIANUM SEED; TURMERIC; GREEN TEA LEAF 3; 3; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54005-0002_2860f802-f434-4480-bd79-81cf3be10fdd 54005-0002 HUMAN OTC DRUG MALE POWERHOUSE Damiana, Dioscorea Villosa, Ginkgo Biloba, Sabal Serrulata, Testosterone, Withania Somnifera LIQUID ORAL 20130812 UNAPPROVED HOMEOPATHIC Infinite Therapies of Sarasota, Inc. TURNERA DIFFUSA LEAFY TWIG; DIOSCOREA VILLOSA TUBER; GINKGO; SAW PALMETTO; TESTOSTERONE; WITHANIA SOMNIFERA ROOT 3; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54031-324_32608f19-e419-4194-ad8a-759458484d77 54031-324 HUMAN OTC DRUG Max Sheer All Day Moisture Defense Sunscreen Lotion SPF 30 LOTION TOPICAL 20130729 OTC MONOGRAPH FINAL part352 Peter Thomas Roth Labs LLC HOMOSALATE; OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE .001; .0008; .0006; .0005; .0003; .0002 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 54057-080_46fe18db-d637-48fc-9785-80eecbe06568 54057-080 HUMAN OTC DRUG CLASSIC TOUCH Foaming Antimicrobial So ap Chloroxylenol LIQUID TOPICAL 20021015 OTC MONOGRAPH NOT FINAL part333E AFFLAB, Affiliated Laboratories, a Division of AFFLINK CHLOROXYLENOL .003 mg/mL N 20181231 54057-081_3b1a545d-1471-46ff-9b93-4822e85611ff 54057-081 HUMAN OTC DRUG CLASSIC TOUCH Foaming Antimicrobial Ltion So ap Chloroxylenol LIQUID TOPICAL 20060630 OTC MONOGRAPH NOT FINAL part333E AFFLAB, Affiliated Laboratories, a Division of AFFLINK CHLOROXYLENOL .003 mg/mL N 20181231 54057-082_e9c68e7d-e281-4181-89fa-3ec9183131f0 54057-082 HUMAN OTC DRUG AFFEX Antimicrobial Foaming Hand So ap Chloroxylenol LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E Afflink, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 54057-083_27711950-1fbc-4cb7-8aa7-d06530e3c8f2 54057-083 HUMAN OTC DRUG AFFEX Foaming Antimicrobial Hand So ap Chloroxylenol LIQUID TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part333E Afflink, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 54057-304_98e03349-1f16-477f-bc4c-7af484a1f67a 54057-304 HUMAN OTC DRUG Alcohol Free Foam Sanitizer Benzalkonium Chloride SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Afflink, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 54057-305_b9b5b204-7f07-4428-81d8-1c64fdb4fa42 54057-305 HUMAN OTC DRUG Antimicrobial Foam Tricolsan SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Afflink, Inc. TRICLOSAN 3 mg/mL E 20171231 54057-400_c5e685d5-4e52-4f33-b57b-b6b8a6c836a0 54057-400 HUMAN OTC DRUG AFFEX Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Afflink, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 54057-401_459ec9d2-9b6d-4b2a-b69e-3e4b36c81f7c 54057-401 HUMAN OTC DRUG CLASSIC TOUCH Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E AFFLAB, Affiliated Laboratories, a Division of AFFLINK BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 54057-524_faeb5c8e-d956-4ad4-a4ef-6f5b5443e97f 54057-524 HUMAN OTC DRUG ANTIMICROBIAL CLEANSER CHLOROXYLENOL SOAP TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part333E AFFLAB, Affiliated Laboratories, a Division of AFFLINK CHLOROXYLENOL 3 g/1000mL E 20171231 54057-681_1ddfa1ec-845f-4a73-aa5d-a6700991887f 54057-681 HUMAN OTC DRUG Antimicrobial Wipes Citrus Scented BENZALKONIUM CHLORIDE CLOTH TOPICAL 20121105 OTC MONOGRAPH NOT FINAL part333E AFFLABS, Affiliated Laboratories, A Division of AFFLINK BENZALKONIUM CHLORIDE .01417 g/1 E 20171231 54057-682_772aec0b-2f01-4928-a7ed-8cdf2cfe7d92 54057-682 HUMAN OTC DRUG Hand Sanitizer Wipes with Aloe BENZALKONIUM CHLORIDE CLOTH TOPICAL 20121105 OTC MONOGRAPH NOT FINAL part333E AFFLABS, Affiliated Laboratories, A Division of AFFLINK BENZALKONIUM CHLORIDE .0067275 g/1 E 20171231 54061-101_6ee89110-ae7c-4814-a8f7-5cafa703741f 54061-101 HUMAN OTC DRUG Phylorinol Phylorinol LIQUID ORAL 20140305 OTC MONOGRAPH NOT FINAL part356 Schaffer Laboratories PHENOL .25 mg/100mL E 20171231 54092-063_c90f52f9-6488-41de-ad2c-9879c0d4ef25 54092-063 HUMAN PRESCRIPTION DRUG Agrylin anagrelide hydrochloride CAPSULE ORAL 19970314 NDA NDA020333 Shire US Manufacturing Inc. ANAGRELIDE HYDROCHLORIDE .5 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 54092-100_47a7ce60-0d3a-42ac-acd4-67bbb8974a93 54092-100 HUMAN PRESCRIPTION DRUG Mesalamine MESALAMINE TABLET, DELAYED RELEASE ORAL 20170829 NDA AUTHORIZED GENERIC NDA022000 Shire US Manufacturing Inc. MESALAMINE 1.2 g/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 54092-171_869c3817-e0b4-4c04-bfdc-787125f53756 54092-171 HUMAN PRESCRIPTION DRUG Carbatrol carbamazepine CAPSULE, EXTENDED RELEASE ORAL 19991222 NDA NDA020712 Shire US Manufacturing Inc. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 54092-172_869c3817-e0b4-4c04-bfdc-787125f53756 54092-172 HUMAN PRESCRIPTION DRUG Carbatrol carbamazepine CAPSULE, EXTENDED RELEASE ORAL 19970930 NDA NDA020712 Shire US Manufacturing Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 54092-173_869c3817-e0b4-4c04-bfdc-787125f53756 54092-173 HUMAN PRESCRIPTION DRUG Carbatrol carbamazepine CAPSULE, EXTENDED RELEASE ORAL 19970930 NDA NDA020712 Shire US Manufacturing Inc. CARBAMAZEPINE 300 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 54092-189_c8cb514f-d0c4-4901-944e-e31214c0faae 54092-189 HUMAN PRESCRIPTION DRUG Pentasa mesalamine CAPSULE ORAL 19930510 NDA NDA020049 Shire US Manufacturing Inc. MESALAMINE 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 54092-191_c8cb514f-d0c4-4901-944e-e31214c0faae 54092-191 HUMAN PRESCRIPTION DRUG Pentasa mesalamine CAPSULE ORAL 20040708 NDA NDA020049 Shire US Manufacturing Inc. MESALAMINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 54092-252_04507da2-f21c-4145-8a07-ac81baad9367 54092-252 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate TABLET, CHEWABLE ORAL 20041026 NDA NDA021468 Shire US Manufacturing Inc. LANTHANUM CARBONATE 500 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 54092-253_04507da2-f21c-4145-8a07-ac81baad9367 54092-253 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate TABLET, CHEWABLE ORAL 20051123 NDA NDA021468 Shire US Manufacturing Inc. LANTHANUM CARBONATE 750 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 54092-254_04507da2-f21c-4145-8a07-ac81baad9367 54092-254 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate TABLET, CHEWABLE ORAL 20051123 NDA NDA021468 Shire US Manufacturing Inc. LANTHANUM CARBONATE 1000 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 54092-256_04507da2-f21c-4145-8a07-ac81baad9367 54092-256 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate POWDER ORAL 20140924 NDA NDA204734 Shire US Manufacturing Inc. LANTHANUM CARBONATE 750 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 54092-257_04507da2-f21c-4145-8a07-ac81baad9367 54092-257 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate POWDER ORAL 20140924 NDA NDA204734 Shire US Manufacturing Inc. LANTHANUM CARBONATE 1000 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 54092-381_62d09e43-4bc7-46b8-8d1c-ba8cf959a872 54092-381 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020522 NDA NDA021303 Shire US Manufacturing Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54092-383_62d09e43-4bc7-46b8-8d1c-ba8cf959a872 54092-383 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20011011 NDA NDA021303 Shire US Manufacturing Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54092-385_62d09e43-4bc7-46b8-8d1c-ba8cf959a872 54092-385 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020522 NDA NDA021303 Shire US Manufacturing Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54092-387_62d09e43-4bc7-46b8-8d1c-ba8cf959a872 54092-387 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20011011 NDA NDA021303 Shire US Manufacturing Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54092-389_62d09e43-4bc7-46b8-8d1c-ba8cf959a872 54092-389 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020522 NDA NDA021303 Shire US Manufacturing Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54092-391_62d09e43-4bc7-46b8-8d1c-ba8cf959a872 54092-391 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20011011 NDA NDA021303 Shire US Manufacturing Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54092-468_0cd3141a-6177-4360-859e-eefd7cdd0eee 54092-468 HUMAN PRESCRIPTION DRUG MYDAYIS DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20170620 NDA NDA022063 Shire US Manufacturing Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54092-471_0cd3141a-6177-4360-859e-eefd7cdd0eee 54092-471 HUMAN PRESCRIPTION DRUG MYDAYIS DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20170620 NDA NDA022063 Shire US Manufacturing Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54092-474_0cd3141a-6177-4360-859e-eefd7cdd0eee 54092-474 HUMAN PRESCRIPTION DRUG MYDAYIS DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20170620 NDA NDA022063 Shire US Manufacturing Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE 9.375; 9.375; 9.375; 9.375 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54092-476_6241b8da-f46d-4f80-a175-72fb8a08705c 54092-476 HUMAN PRESCRIPTION DRUG Lialda mesalamine TABLET, DELAYED RELEASE ORAL 20070116 NDA NDA022000 Shire US Manufacturing Inc. MESALAMINE 1.2 g/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 54092-477_0cd3141a-6177-4360-859e-eefd7cdd0eee 54092-477 HUMAN PRESCRIPTION DRUG MYDAYIS DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20170620 NDA NDA022063 Shire US Manufacturing Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE 12.5; 12.5; 12.5; 12.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54092-513_bb8becbe-aa1b-455f-ab05-e24dfd820527 54092-513 HUMAN PRESCRIPTION DRUG Intuniv guanfacine TABLET, EXTENDED RELEASE ORAL 20090902 NDA NDA022037 Shire US Manufacturing Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 54092-515_bb8becbe-aa1b-455f-ab05-e24dfd820527 54092-515 HUMAN PRESCRIPTION DRUG Intuniv guanfacine TABLET, EXTENDED RELEASE ORAL 20090902 NDA NDA022037 Shire US Manufacturing Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 54092-517_bb8becbe-aa1b-455f-ab05-e24dfd820527 54092-517 HUMAN PRESCRIPTION DRUG Intuniv guanfacine TABLET, EXTENDED RELEASE ORAL 20090902 NDA NDA022037 Shire US Manufacturing Inc. GUANFACINE HYDROCHLORIDE 3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 54092-519_bb8becbe-aa1b-455f-ab05-e24dfd820527 54092-519 HUMAN PRESCRIPTION DRUG Intuniv guanfacine TABLET, EXTENDED RELEASE ORAL 20090902 NDA NDA022037 Shire US Manufacturing Inc. GUANFACINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 54092-520_bb8becbe-aa1b-455f-ab05-e24dfd820527 54092-520 HUMAN PRESCRIPTION DRUG Intuniv guanfacine KIT 20090902 NDA NDA022037 Shire US Manufacturing Inc. N 20181231 54092-606_efac2b23-dacf-4c92-8684-29282fcdbf41 54092-606 HUMAN PRESCRIPTION DRUG Xiidra Lifitegrast SOLUTION/ DROPS OPHTHALMIC 20160711 NDA NDA208073 Shire US Manufacturing Inc. LIFITEGRAST 50 mg/mL Lymphocyte Function-Associated Antigen-1 Antagonist [EPC],Lymphocyte Function-Associated Antigen-1 Antagonists [MoA] N 20191231 54092-700_2db83830-65c2-6b1e-e054-00144ff8d46c 54092-700 HUMAN PRESCRIPTION DRUG ELAPRASE idursulfase SOLUTION, CONCENTRATE INTRAVENOUS 20060724 BLA BLA125151 Shire US Manufacturing Inc. IDURSULFASE 6 mg/3mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC] N 20181231 54092-701_e9017cc6-4778-4ff9-8a84-cabece186f05 54092-701 HUMAN PRESCRIPTION DRUG VPRIV velaglucerase alfa INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100226 NDA NDA022575 Shire US Manufacturing Inc. VELAGLUCERASE ALFA 2.5 mg/mL Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC] N 20181231 54092-702_c3e90288-9ebb-41f2-a58c-fffec2cf5172 54092-702 HUMAN PRESCRIPTION DRUG Firazyr icatibant acetate INJECTION, SOLUTION SUBCUTANEOUS 20110825 NDA NDA022150 Shire US Manufacturing Inc. ICATIBANT ACETATE 30 mg/3mL Bradykinin B2 Receptor Antagonist [EPC],Bradykinin B2 Receptor Antagonists [MoA] N 20181231 54095-111_6dd21e95-eb18-4f04-9099-a8fbc9d10b9f 54095-111 HUMAN OTC DRUG PsorMedicor Premium Skin Care Product COAL TAR OINTMENT TOPICAL 20131111 OTC MONOGRAPH FINAL part358H Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD COAL TAR 2.5 g/100g E 20171231 54102-000_48a9c577-65b1-541a-e054-00144ff8d46c 54102-000 HUMAN OTC DRUG Q Health Pain Relief MENTHOL LIQUID TOPICAL 20120913 OTC MONOGRAPH NOT FINAL part348 QCAN International Inc. MENTHOL 80 mg/mL N 20181231 54108-0333_a6de5593-7f3a-424f-9b39-97dc75f50cb6 54108-0333 HUMAN OTC DRUG Evenly Radiant Brightening Day Creme SPF 15 Octinoxate and Zinc Oxide CREAM TOPICAL 20140417 OTC MONOGRAPH NOT FINAL part352 derma e OCTINOXATE; ZINC OXIDE 55; 55 mg/g; mg/g E 20171231 54111-111_7ad16cb1-e20a-46a3-9d2b-b8d1fcef5d9e 54111-111 HUMAN OTC DRUG BRODA Acne Spa SALICYLIC ACID GEL TOPICAL 20131001 OTC MONOGRAPH FINAL part333D Bentley Laboratories, LLC SALICYLIC ACID 2 g/100g N 20181231 54111-112_146b7a80-e10f-40b0-9629-36c044e345d6 54111-112 HUMAN OTC DRUG BRODA Acne SALICYLIC ACID GEL TOPICAL 20131029 OTC MONOGRAPH FINAL part333D Bentley Laboratories, LLC SALICYLIC ACID .4 g/20g N 20191231 54111-113_f2b36f8d-4de8-4e83-baa6-71fe2a7697f2 54111-113 HUMAN OTC DRUG YES to coconut ALLANTOIN CREAM TOPICAL 20140505 OTC MONOGRAPH FINAL part347 Bentley Laboratories, LLC ALLANTOIN .425 g/85mL N 20191231 54111-114_edf15173-e923-4b1c-aea0-5961b30736a8 54111-114 HUMAN OTC DRUG Yes to tomatoes SALICYLIC ACID LIQUID TOPICAL 20140904 OTC MONOGRAPH FINAL part333D Bentley Laboratories, LLC SALICYLIC ACID 5.3 g/265mL N 20191231 54111-115_248bab74-bfa0-445d-bc17-d5b1a0fd3f1c 54111-115 HUMAN OTC DRUG dr dennis gross Trifix Acne Clearing SULFUR LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333D Bentley Laboratories, LLC SULFUR 1.5 g/50mL N 20181231 54111-116_1d6a2866-cef2-4410-baa1-4280224e1f72 54111-116 HUMAN OTC DRUG dr dennis gross Correct and Perfect SULFUR CREAM TOPICAL 20100501 OTC MONOGRAPH FINAL part333D Bentley Laboratories, LLC SULFUR .4875 g/15mL N 20181231 54111-117_db918c8c-3bbf-41fc-8e56-a3a4c4f9180d 54111-117 HUMAN OTC DRUG HydroPeptide SPOT CORRECTION SULFUR OINTMENT TOPICAL 20140517 OTC MONOGRAPH FINAL part333D Bentley Laboratories, LLC SULFUR 1.5 g/15mL N 20181231 54111-118_31edd9cd-851b-481a-b382-d75a6972cfb3 54111-118 HUMAN OTC DRUG MALIN GOETZ acne treatment nighttime SULFUR LOTION TOPICAL 20131101 OTC MONOGRAPH FINAL part333D Bentley Laboratories, LLC SULFUR 1.4 g/14mL N 20181231 54111-119_6e1d8cfd-2d32-41f8-a9db-73501fadc90c 54111-119 HUMAN OTC DRUG RODAN and FIELDS ENHANCEMENTS LIGHT TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20120815 OTC MONOGRAPH FINAL part352 Bentley Laboratories, LLC TITANIUM DIOXIDE; ZINC OXIDE .384; .196 g/4g; g/4g N 20191231 54111-120_6e1d8cfd-2d32-41f8-a9db-73501fadc90c 54111-120 HUMAN OTC DRUG RODAN and FIELDS ENHANCEMENTS MEDIUM TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20120905 OTC MONOGRAPH FINAL part352 Bentley Laboratories, LLC TITANIUM DIOXIDE; ZINC OXIDE .384; .196 g/4g; g/4g N 20191231 54111-121_6e1d8cfd-2d32-41f8-a9db-73501fadc90c 54111-121 HUMAN OTC DRUG RODAN and FIELDS ENHANCEMENTS BRONZE TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20130419 OTC MONOGRAPH FINAL part352 Bentley Laboratories, LLC TITANIUM DIOXIDE; ZINC OXIDE .384; .196 g/4g; g/4g N 20191231 54111-122_f49399e7-0fe0-4db1-baf1-47a7241066bb 54111-122 HUMAN OTC DRUG RODAN and FIELDS UNBLEMISH TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20100305 OTC MONOGRAPH FINAL part352 Bentley Laboratories, LLC TITANIUM DIOXIDE; ZINC OXIDE .21; 1.425 g/30mL; g/30mL N 20191231 54111-123_fa350899-cc60-4e64-823e-26da675a2c48 54111-123 HUMAN OTC DRUG RODAN and FIELDS SOOTHE ALLANTOIN, DIMETHICONE CREAM TOPICAL 20100205 OTC MONOGRAPH FINAL part347 Bentley Laboratories, LLC ALLANTOIN; DIMETHICONE .25; 1.45 g/50mL; g/50mL N 20191231 54111-124_93dda0e2-a598-4e48-a434-393245f1c459 54111-124 HUMAN OTC DRUG dr dennis gross All-Over Blemish SALICYLIC ACID GEL TOPICAL 20091101 OTC MONOGRAPH FINAL part333D Bentley Laboratories, LLC SALICYLIC ACID 1 g/50mL N 20181231 54111-125_20b64d45-21c2-464c-a951-7a7917c5ea7c 54111-125 HUMAN OTC DRUG nyakio hydrating face AVOBENZONE, HOMOSALATE, OXYBENZONE LOTION TOPICAL 20130101 OTC MONOGRAPH FINAL part352 Bentley Laboratories, LLC AVOBENZONE; HOMOSALATE; OXYBENZONE 1.5; 5; 2.5 g/50g; g/50g; g/50g N 20191231 54111-126_fa68afe2-8fb9-4b65-bfc2-b6fcda152ef9 54111-126 HUMAN OTC DRUG LIP HEALER OXYBENZONE, PADIMATE O STICK TOPICAL 20050101 OTC MONOGRAPH FINAL part352 Bentley Laboratories, LLC OXYBENZONE; PADIMATE O .1275; .2975 g/4.25g; g/4.25g N 20181231 54111-128_6fb9765f-5ec6-4db6-9539-bb4abb84c206 54111-128 HUMAN OTC DRUG Oasis Daily Defense AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20160601 OTC MONOGRAPH FINAL part352 Bentley Laboratories, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 3.75; 2.5; 4.5; 2.5 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL N 20181231 54111-129_de1ba390-6eaf-4e0b-8051-0108252cf300 54111-129 HUMAN OTC DRUG WATERBRIGHT RADIATING AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20160601 OTC MONOGRAPH FINAL part352 Bentley Laboratories, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 3.75; 2.5; 4.5; 2.5 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL N 20181231 54111-130_a0927a99-de64-44f8-b74f-fbe7d28d6f30 54111-130 HUMAN OTC DRUG INFINITY AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20160601 OTC MONOGRAPH FINAL part352 Bentley Laboratories, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 1.5; 3.75; 2.5; 2.5; 4.5 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL N 20181231 54111-131_03cc3ab7-91c0-4608-a6d6-04d906bea3ff 54111-131 HUMAN OTC DRUG Bliss Triple Oxygen Ultimate Protection UV Moisturizer SPF 33 AVOBENZONE, ENSULIZOLE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 Bentley Laboratories, LLC AVOBENZONE; ENSULIZOLE; OCTOCRYLENE; OXYBENZONE 1.5; 1; 3.5; 2.5 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 54111-132_5e8cfc05-512f-4b3c-9387-fe44d8820937 54111-132 HUMAN OTC DRUG H2O Beauty AQUADEFENSE PROTECTIVE MATCHA SPF 40 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20161206 OTC MONOGRAPH FINAL part352 Bentley Laboratories, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.5; 4; 2.5; 3 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 54111-133_a90b1fca-e986-4ee7-950c-686c98e135a2 54111-133 HUMAN OTC DRUG MOROCCAN Lightweight Hydrating Sun Protection SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20161008 OTC MONOGRAPH FINAL part352 Bentley Laboratories, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.5; 4; 2.5; 3 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 54111-134_ecd9c133-0641-4bba-9c2c-d475d2af6936 54111-134 HUMAN OTC DRUG MARIO BADESCU SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170201 OTC MONOGRAPH FINAL part352 Bentley Laboratories LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 1.5; 3.75; 2.5; 5 g/59mL; g/59mL; g/59mL; g/59mL N 20181231 54111-135_4aaca05f-4efb-4e69-889d-d8cf28a6d4a0 54111-135 HUMAN OTC DRUG Mario Badescu SPF 17 AVOBENZONE, OCTINOXATE, OCTOCRYLENE LOTION TOPICAL 20170301 OTC MONOGRAPH FINAL part352 Bentley Laboratories LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1; 2.5; 3 g/29mL; g/29mL; g/29mL N 20181231 54111-136_7d27165c-89ee-4f5b-a18c-8191d3372c7e 54111-136 HUMAN OTC DRUG Mario Badescu Collagen SPF 15 AVOBENZONE, OCTINOXATE, OXYBENZONE LOTION TOPICAL 20170413 OTC MONOGRAPH FINAL part352 Bentley Laboratories LLC AVOBENZONE; OCTINOXATE; OXYBENZONE 1.2; 4.24; 2.84 g/59mL; g/59mL; g/59mL N 20181231 54111-137_5d767dc3-d672-4d51-ad9c-3035342528df 54111-137 HUMAN OTC DRUG MARIO BADESCU ALOE SPF AVOBENZONE, OCTINOXATE, OXYBENZONE LOTION TOPICAL 20170504 OTC MONOGRAPH FINAL part352 Bentley Laboratories LLC AVOBENZONE; OCTINOXATE; OXYBENZONE 1.2; 4.24; 2 g/59mL; g/59mL; g/59mL N 20181231 54111-205_6ce6bad5-1081-4d25-b864-141782fac80e 54111-205 HUMAN OTC DRUG Hair Regrow 5% Minoxidil Topical Solution SOLUTION TOPICAL 20040824 ANDA ANDA076239 Bentley Laboratories, LLC MINOXIDIL 50 mg/mL N 20191231 54118-5152_9e6cb155-bd12-4015-a549-2f2508d0134a 54118-5152 HUMAN OTC DRUG Immune Support System Penicillium notatum, Penicillium frequentans, Aconitum napellus, Colloidal silver SPRAY NASAL 20121004 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM; ACONITUM NAPELLUS; SILVER 4; 4; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 54118-7011_97711c5b-dfd4-49d6-b34b-02f6be6a2b38 54118-7011 HUMAN OTC DRUG Rena Code Rena Code SOLUTION/ DROPS ORAL 20150721 UNAPPROVED HOMEOPATHIC ABCO Labratories, Inc. ADENOSINE TRIPHOSPHATE; BERBERIS VULGARIS WHOLE; BOS TAURUS URINARY BLADDER; BRYONIA ALBA WHOLE; EUPATORIUM PURPUREUM ROOT; HYDRANGEA ARBORESCENS WHOLE; BEEF KIDNEY; MERCURIC CHLORIDE; SODIUM SULFATE; PARSLEY; RUBIA TINCTORUM WHOLE; SOLIDAGO VIRGAUREA WHOLE; ARCTOSTAPHYLOS UVA-URSI WHOLE; CHERRY PLUM; POPULUS TREMULA FLOWERING TOP 5; 3; 6; 12; 12; 12; 6; 12; 6; 3; 6; 3; 3; 30; 30 [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_C]/60mL E 20171231 54118-7017_770e03d2-05d6-4892-902e-feb2b4f2975c 54118-7017 HUMAN OTC DRUG Ultimate Phenolics Ultimate Phenolics SOLUTION/ DROPS ORAL 20150716 UNAPPROVED HOMEOPATHIC ABCO Labratories, Inc. ACETYLCHOLINE CHLORIDE; ACETALDEHYDE; PARSLEY; ASCORBIC ACID; BUTYLATED HYDROXYTOLUENE; CAFFEIC ACID; CANDIDA ALBICANS; CHLOROGENIC ACID; CINNAMIC ACID; CONIFERYL ALCOHOL; COUMARIN; DOPAMINE; ESTROGENS, CONJUGATED; .GAMMA.-AMINOBUTYRIC ACID; GALLIC ACID; HISTAMINE; INDOLE; DOPA, DL-; MALVIN; YEAST MANNAN; MELATONIN; MENADIONE; NORADRENALINE, (+/-)-; OCTOPAMINE; PHENYLALANINE; PHENYL ISOTHIOCYANATE; PHLORIZIN; PIPERINE; PROGESTERONE; PYRROLE; QUERCETIN; RUTIN; SALSOLINOL; SEROTONIN; TAURINE; TESTOSTERONE; TRYPTOPHAN; ADENOSINE TRIPHOSPHATE; BOS TAURUS MESENCEPHALON 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7103_5b66287e-b9e8-4556-b713-349e705890f7 54118-7103 HUMAN OTC DRUG Myco-Tox Myco-Tox SOLUTION/ DROPS ORAL 20150813 UNAPPROVED HOMEOPATHIC ABCO Labratories, Inc. BOS TAURUS ADRENAL GLAND; ARSENIC; ADENOSINE TRIPHOSPHATE; SODIUM BORATE; ECHINACEA ANGUSTIFOLIA; GLIOTOXIN; HYDRASTIS CANADENSIS WHOLE; BEEF LIVER; LOMATIUM DISSECTUM WHOLE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; PHYTOLACCA AMERICANA WHOLE; BOS TAURUS SPLEEN; STACHYBOTRYS CHARTARUM; TABEBUIA IMPETIGINOSA WHOLE; BOS TAURUS THYMUS; ELYMUS REPENS WHOLE 5; 6; 5; 12; 12; 12; 3; 3; 3; 3; 6; 12; 3; 12; 3; 3; 3 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7109_b59c279e-bb13-467f-ab30-8c671a16ae4f 54118-7109 HUMAN OTC DRUG Pre and Post Milieu Pre and Post Milieu SOLUTION/ DROPS ORAL 20150825 UNAPPROVED HOMEOPATHIC ABCO Labratories, Inc. ARNICA MONTANA; BELLADONNA LEAF; CORTISONE; HYPERICUM PERFORATUM; SYMPHYTUM OFFICINALE WHOLE; VALERIANA OFFICINALIS WHOLE 200; 6; 6; 6; 12; 1 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7114_2e70274f-df8a-4c69-90e7-3cbbea1e117c 54118-7114 HUMAN OTC DRUG Throat Milieu Throat Milieu SOLUTION/ DROPS ORAL 20150824 UNAPPROVED HOMEOPATHIC ABCO labratories, Inc. APIS MELLIFERA; BAPTISIA TINCTORIA; BELLADONNA LEAF; COMMIPHORA MYRRHA WHOLE; ECHINACEA ANGUSTIFOLIA; FERRIC PHOSPHATE; CALCIUM SULFIDE; HYDRASTIS CANADENSIS WHOLE; LACHESIS MUTA WHOLE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA WHOLE; SALVIA OFFICINALIS WHOLE; CLOVE; THYMUS VULGARIS WHOLE 12; 3; 12; 1; 1; 6; 12; 1; 12; 12; 3; 1; 1; 1 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7132_eaac1277-a56b-43a8-bffd-a038882b754f 54118-7132 HUMAN OTC DRUG Oral HCG Homeopathic Hypothalamus, Pituitary, Hepar Suis, Methyl B12 SOLUTION/ DROPS ORAL 20140305 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. BOS TAURUS HYPOTHALAMUS; BOS TAURUS PITUITARY GLAND; PORK LIVER; METHYLCOBALAMIN; PORK KIDNEY; GAMBOGE; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE; GLUCAGON; INSULIN HUMAN; GENTIANA LUTEA ROOT; SEMECARPUS ANACARDIUM JUICE; LACTIC ACID, L-; GONADOTROPHIN, CHORIONIC 6; 6; 8; 8; 8; 12; 12; 12; 3; 30; 30; 30; 30; 5; 15; 3; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL E 20171231 54118-7134_c9311f00-e85a-4029-af87-f90c637bbc08 54118-7134 HUMAN OTC DRUG BioCell Salts BioCell Slats SOLUTION/ DROPS ORAL 20150714 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. CALCIUM FLUORIDE; CALCIUM SULFATE; POTASSIUM CHLORIDE; CALCIUM PHOSPHATE; FERRUM PHOSPHORICUM; POTASSIUM SULFATE; SODIUM CHLORIDE; SODIUM SULFATE; MAGNESIUM PHOSPHATE ANHYDROUS; SODIUM PHOSPHATE; SILICON DIOXIDE; ADENOSINE TRIPHOSPHATE; BOS TAURUS PARATHYROID GLAND; BOS TAURUS HYPOTHALAMUS 6; 3; 3; 3; 3; 3; 6; 3; 3; 3; 6; 5; 6; 6 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_C]/60mL E 20171231 54118-7136_16dbc8f0-a2c5-44df-93f3-6dc2349aac8a 54118-7136 HUMAN OTC DRUG Pineal Code Pineal Code SOLUTION/ DROPS ORAL 20150717 UNAPPROVED HOMEOPATHIC ABCO Labratories, Inc. BOS TAURUS PINEAL GLAND; GOLD; BERBERIS VULGARIS FRUIT; CALCIUM FLUORIDE 6; 5; 3; 12 [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_X]/60mL E 20171231 54118-7141_20983373-09f1-4a02-ae05-44fc0b377d25 54118-7141 HUMAN OTC DRUG GlycoPan Tox Argentium nitricum, Kali carbonicum, Glycirrhiza glabra SOLUTION/ DROPS ORAL 20130201 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. SILVER NITRATE; POTASSIUM CARBONATE; GLYCYRRHIZA GLABRA; MAMMAL LIVER; BOS TAURUS ADRENAL GLAND; SKIM MILK; SUS SCROFA PANCREAS; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SUCROSE; URANYL NITRATE HEXAHYDRATE; THYROID, UNSPECIFIED; BOS TAURUS PITUITARY GLAND; CHOLESTEROL; KIDNEY BEAN; GYMNEMA SYLVESTRE LEAF; RHUS AROMATICA ROOT BARK; FENUGREEK SEED; CHROMIUM; SYZYGIUM CUMINI SEED; ZINC; SELENIUM; BOS TAURUS MESENCHYME; ADENOSINE TRIPHOSPHATE 9; 9; 1; 6; 6; 6; 6; 3; 30; 4; 6; 30; 6; 6; 7; 1; 1; 3; 3; 3; 1; 9; 9; 6; 5 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7188_6cf55f5e-8527-44d5-a70e-4b57ba6e28a8 54118-7188 HUMAN OTC DRUG HCG Plus Human Chorionic Gonadotropin (HCG), Garcinia Cambogia, Hypothalamus SOLUTION/ DROPS ORAL 20140516 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. AMERICAN GINSENG; FUCUS VESICULOSUS; CALCIUM ARSENATE; GLUTAMIC ACID; LEUCINE; ARGININE; ACETYLCARNITINE; ORNITHINE; GONADOTROPHIN, CHORIONIC 6; 6; 6; 6; 6; 3; 3; 12; 12 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7196_a155c3ab-8ab1-42be-b622-adfeb4aecabe 54118-7196 HUMAN OTC DRUG Oral hCG Activator Hypothalamus, Hepar Suis, Methyl B12, Renal Suis, Gambogia, Graphites SOLUTION/ DROPS ORAL 20140305 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. BOS TAURUS HYPOTHALAMUS; PORK LIVER; METHYLCOBALAMIN; PORK KIDNEY; GAMBOGE; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; ARGININE; LEVOCARNITINE; TRYPTOPHAN; PHENYLALANINE; THYROID, UNSPECIFIED; BOS TAURUS PITUITARY GLAND; GENTIANA LUTEA ROOT; SEMECARPUS ANACARDIUM JUICE 6; 8; 8; 8; 12; 12; 12; 3; 30; 30; 30; 30; 3; 12; 12; 12; 12; 3; 6; 5; 15 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL E 20171231 54118-7199_0cca253d-60c2-4d31-b7d6-0c296e941f9a 54118-7199 HUMAN OTC DRUG Immune Support System Penicillium Notatum, Penicillium Frequentans, Aconitum Napellus, Ferrum Phosphoricum TABLET ORAL 20121001 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM; ACONITUM NAPELLUS; FERROSOFERRIC PHOSPHATE 4; 6; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 54118-7232_dc0a2e1f-4ae8-4c0f-8f12-a64b80c30789 54118-7232 HUMAN OTC DRUG HCG Plus Human Chorionic Gonadotropin (HCG), Garcinia Cambogia, Hypothalamus SOLUTION/ DROPS ORAL 20140405 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. GONADOTROPHIN, CHORIONIC; GARCINIA CAMBOGIA FRUIT; BOS TAURUS HYPOTHALAMUS; BOS TAURUS BRAIN; PORK LIVER; METHYLCOBALAMIN; SUS SCROFA PANCREAS; BEEF KIDNEY; TRIPE; CALCIUM CARBONATE; GELSEMIUM SEMPERVIRENS WHOLE; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; SEMECARPUS ANACARDIUM JUICE; GLUCAGON; INSULIN HUMAN; LACTIC ACID, L-; PROTEUS INCONSTANS; THYROID, UNSPECIFIED; BOS TAURUS PITUITARY GLAND; CALCIUM FLUORIDE; FUCUS VESICULOSUS; AMMONIUM CARBONATE 12; 12; 6; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 30; 6; 30; 30; 30; 30; 12; 12; 6; 3; 6 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7967_1fedc888-9dc1-4971-baa0-46086be2b64c 54118-7967 HUMAN OTC DRUG Lymph 1 Acute Adrenal, Apis mellifica SOLUTION/ DROPS ORAL 20110228 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. BOS TAURUS ADRENAL GLAND; APIS MELLIFERA; ARANEUS DIADEMATUS; ADENOSINE TRIPHOSPHATE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; FUMARIA OFFICINALIS FLOWERING TOP; GALIUM APARINE; GRAPHITE; BOS TAURUS HYPOTHALAMUS; POTASSIUM IODIDE; LACHESIS MUTA VENOM; MERCUROUS IODIDE; VIROLA SEBIFERA RESIN; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; MARITIME PINE; BOS TAURUS PITUITARY GLAND; TOXICODENDRON PUBESCENS LEAF; SCROPHULARIA NODOSA; SULFUR; THYROID, BOVINE; UNCARIA TOMENTOSA LEAF; VESPA CRABRO 3; 3; 9; 4; 6; 9; 6; 1; 6; 9; 6; 3; 3; 12; 9; 9; 12; 2; 6; 3; 12; 9; 12; 6; 3; 12 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7971_f4e4e216-f0bd-4fda-a43a-4d25d9be621f 54118-7971 HUMAN OTC DRUG Ultimate Fields Ultimate Fields SOLUTION/ DROPS ORAL 20150715 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. AGRIMONIA EUPATORIA; POPULUS ALBA WHOLE; FAGUS SYLVATICA FLOWERING TOP; CERATOSTIGMA WILLMOTTIANUM FLOWER; PRUNUS CERASIFERA FLOWER; AESCULUS HIPPOCASTANUM WHOLE; CICHORIUM INTYBUS FLOWER; MALUS SYLVESTRIS FLOWER; ULMUS ALATA WHOLE; GENTIANA ACAULIS; ULEX EUROPAEUS FLOWER; CALLUNA VULGARIS FLOWERING TOP; ILEX AQUIFOLIUM FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; CARPINUS BETULUS FLOWERING TOP; IMPATIENS CAPENSIS WHOLE; LARIX DECIDUA WHOLE; MIMULUS GUTTATUS FLOWERING TOP; BRASSICA NIGRA WHOLE; QUERCUS ROBUR FLOWER; OLEA EUROPAEA FRUIT VOLATILE OIL; PINUS SYLVESTRIS FLOWERING TOP; AESCULUS CARNEA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; SCLERANTHUS ANNUUS FLOWERING TOP; ORNITHOGALUM UMBELLATUM; CASTANEA SATIVA FLOWER; VERBENA OFFICINALIS FLOWERING TOP; VITIS VINIFERA FLOWERING TOP; JUGLANS REGIA FLOWERING TOP; HOTTONIA PALUSTRIS FLOWER; AESCULUS HIPPOCASTANUM FLOWER; AVENA FATUA WHOLE; ROSA CANINA FLOWER; SALIX ALBA FLOWERING TOP; ADENOSINE TRIPHOSPHATE; BOS TAURUS PINEAL GLAND; BOS TAURUS THYMUS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 5; 6; 6 [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_C]/60mL E 20171231 54118-7972_9baf9418-5173-409f-a624-eaee0c2fdef3 54118-7972 HUMAN OTC DRUG Ultimate Rescue Cherry Plum, Clematis, Impatiens, Rock rose, Star of Bethlehem, ATP, Pineal, thymus SOLUTION/ DROPS ORAL 20110228 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. CHERRY PLUM; CLEMATIS CHINENSIS ROOT; IMPATIENS BALSAMINA LEAF; CISTUS INCANUS WHOLE; ORNITHOGALUM UMBELLATUM; ADENOSINE TRIPHOSPHATE; BOS TAURUS PINEAL GLAND; BOS TAURUS THYMUS 30; 30; 30; 30; 30; 5; 6; 6 [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_C]/60mL E 20171231 54118-7976_f294fc3e-4d48-4774-a032-aac88ccd9edc 54118-7976 HUMAN OTC DRUG Aller-Tox 1 Acetaldehyde, Adrenal, Argentum Nitricum SOLUTION/ DROPS ORAL 20121121 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. ACETALDEHYDE; BOS TAURUS ADRENAL GLAND; SILVER NITRATE; ARSENIC TRIOXIDE; ADENOSINE TRIPHOSPHATE; CORTISONE; BERBERIS VULGARIS ROOT BARK; CORTICOTROPIN; GALLIC ACID MONOHYDRATE; HISTAMINE; HYALURONIDASE; INTERFERON BETA-1A; MAMMAL LIVER; LYCOPODIUM CLAVATUM SPORE; BOS TAURUS MESENCHYME; SEROTONIN; HYDRANGEA ARBORESCENS ROOT; STRYCHNOS NUX-VOMICA SEED 6; 3; 6; 6; 5; 6; 30; 12; 6; 6; 6; 6; 5; 12; 6; 6; 6; 12 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7977_36da272b-ede3-4282-b0db-feebf6e9ccad 54118-7977 HUMAN OTC DRUG Aller - Tox 11 Adrenal, Allium cepa, Ambrosia artemisiaefolia SOLUTION/ DROPS ORAL 20121128 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc BOS TAURUS ADRENAL GLAND; ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ADENOSINE TRIPHOSPHATE; COUMARIN; EUPHRASIA STRICTA; HISTAMINE; BEEF LIVER; BEEF LUNG; MENADIONE; BOS TAURUS MESENCHYME; PHOSPHORUS; PIPERINE; HYALURONIDASE; PULSATILLA PRATENSIS; RUTIN; SCHOENOCAULON OFFICINALE SEED; SULFUR 3; 3; 3; 12; 5; 6; 3; 6; 5; 3; 5; 6; 12; 5; 9; 12; 5; 3; 12 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7978_7f169fa8-7925-4baa-8fe1-644544b2a3a7 54118-7978 HUMAN OTC DRUG Amoeba Tox Adrenal, Amoeba nosodes, Artemisia absinthium SOLUTION/ DROPS ORAL 20121128 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc BOS TAURUS ADRENAL GLAND; ENTAMOEBA HISTOLYTICA; WORMWOOD; ADENOSINE TRIPHOSPHATE; BAPTISIA TINCTORIA; CAJUPUT OIL; CAPSICUM; SENNA LEAF; CHELONE GLABRA; CINCHONA OFFICINALIS BARK; ALPINE STRAWBERRY; GENTIANA LUTEA ROOT; GOLDENSEAL; CEANOTHUS AMERICANUS LEAF; MAMMAL LIVER; LYCOPODIUM CLAVATUM SPORE; BOS TAURUS MESENCHYME; STRYCHNOS NUX-VOMICA SEED; QUASSIA AMARA WOOD; BOS TAURUS SPLEEN 6; 30; 6; 5; 3; 1; 3; 3; 3; 12; 3; 6; 3; 6; 5; 12; 6; 12; 3; 5 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_Q]/60mL; [hp_X]/60mL E 20171231 54118-7979_4946546b-379a-4269-975f-2d96cf2b13b9 54118-7979 HUMAN OTC DRUG Bacteria Tox Adrenal, ATP, Bac nosode, Belladonna SOLUTION/ DROPS ORAL 20121130 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. BOS TAURUS ADRENAL GLAND; ADENOSINE TRIPHOSPHATE; MYCOBACTERIUM TUBERCULOSIS; ATROPA BELLADONNA; MYRRH; CROTALUS HORRIDUS HORRIDUS VENOM; GOLDENSEAL; HYPERICUM PERFORATUM; BEEF LIVER; LOMATIUM DISSECTUM ROOT; BORRELIA BURGDORFERI; BOS TAURUS MESENCHYME; NASTURTIUM OFFICINALE; PHOSPHORUS; BOS TAURUS SPLEEN; TABEBUIA IMPETIGINOSA BARK; HUMAN THYMUS 3; 5; 12; 6; 3; 12; 3; 12; 3; 3; 12; 6; 3; 12; 5; 3; 5 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7981_f2b2191b-d215-4ae4-b8d8-004ecec8ee83 54118-7981 HUMAN OTC DRUG Chem - Tox Adrenal, Arctium lappa, ATP, Belladonna, Chemical isodes SOLUTION/ DROPS ORAL 20121130 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. BOS TAURUS ADRENAL GLAND; ARCTIUM LAPPA WHOLE; ADENOSINE TRIPHOSPHATE; ATROPA BELLADONNA; ARSENIC TRIOXIDE; LICORICE; BEEF KIDNEY; BEEF LIVER; LYCOPODIUM CLAVATUM SPORE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; FRANGULA PURSHIANA BARK; THYROID, BOVINE; TRIFOLIUM PRATENSE FLOWER; ELYMUS REPENS ROOT 5; 3; 5; 12; 12; 3; 3; 3; 12; 3; 6; 6; 12; 6; 12; 3; 3; 5; 3; 3 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7990_a6097ed7-2469-4dbf-b3d5-acf11dda0470 54118-7990 HUMAN OTC DRUG Gyne - Tox Adrenal, Angelica Atropurpurea, Boricum Acidum, ATP SOLUTION/ DROPS ORAL 20121219 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc. BOS TAURUS ADRENAL GLAND; ANGELICA ATROPURPUREA ROOT; BORIC ACID; ADENOSINE TRIPHOSPHATE; BOS TAURUS MESENCHYME; CANDIDA ALBICANS; BLACK COHOSH; WOOD CREOSOTE; BOS TAURUS LYMPH; GONORRHEAL URETHRAL SECRETION HUMAN; MERCURIUS SOLUBILIS; ESTRONE; BOS TAURUS OVARY; BOS TAURUS PLACENTA; SCABIES LESION LYSATE (HUMAN); ANEMONE NEMOROSA; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; TREPONEMIC SKIN CANKER HUMAN; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; BOS TAURUS UTERUS 6; 3; 12; 5; 6; 6; 3; 12; 6; 30; 12; 30; 5; 5; 30; 12; 12; 12; 30; 12; 6; 5 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54118-7993_838c7ad0-cfda-4c83-b035-28b17bad40d3 54118-7993 HUMAN OTC DRUG HZ - Tox Arsenicum album, Asclepias tuberus, ATP SOLUTION/ DROPS ORAL 20121221 UNAPPROVED HOMEOPATHIC ABCO Laboratories, Inc ARSENIC; ASCLEPIAS TUBEROSA FLOWERING TOP; ADENOSINE TRIPHOSPHATE; BAPTISIA TINCTORIA; HUMAN HERPESVIRUS 5; LOMATIUM DISSECTUM ROOT; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; RANUNCULUS BULBOSUS; BOS TAURUS SPLEEN; THUJA OCCIDENTALIS LEAF; BOS TAURUS THYMUS; THYROID, BOVINE; CAT'S CLAW; CALCIUM SULFATE ANHYDROUS; TOXICODENDRON PUBESCENS LEAF 3; 3; 5; 3; 30; 3; 3; 6; 3; 12; 3; 3; 12; 5; 5; 1; 6; 6 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; 1/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL E 20171231 54123-114_935430bb-7028-4f47-98ab-1c2145cecdcf 54123-114 HUMAN PRESCRIPTION DRUG Zubsolv buprenorphine hydrochloride and naloxone hydrochloride TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20141211 NDA NDA204242 Orexo US, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 11.4; 2.9 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 54123-907_935430bb-7028-4f47-98ab-1c2145cecdcf 54123-907 HUMAN PRESCRIPTION DRUG Zubsolv buprenorphine hydrochloride and naloxone hydrochloride TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20130704 NDA NDA204242 Orexo US, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE .7; .18 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 54123-914_935430bb-7028-4f47-98ab-1c2145cecdcf 54123-914 HUMAN PRESCRIPTION DRUG Zubsolv buprenorphine hydrochloride and naloxone hydrochloride TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20130704 NDA NDA204242 Orexo US, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 1.4; .36 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 54123-929_935430bb-7028-4f47-98ab-1c2145cecdcf 54123-929 HUMAN PRESCRIPTION DRUG Zubsolv buprenorphine hydrochloride and naloxone hydrochloride TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20130704 NDA NDA204242 Orexo US, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 2.9; .71 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 54123-957_935430bb-7028-4f47-98ab-1c2145cecdcf 54123-957 HUMAN PRESCRIPTION DRUG Zubsolv buprenorphine hydrochloride and naloxone hydrochloride TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20130704 NDA NDA204242 Orexo US, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 5.7; 1.4 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 54123-986_935430bb-7028-4f47-98ab-1c2145cecdcf 54123-986 HUMAN PRESCRIPTION DRUG Zubsolv buprenorphine hydrochloride and naloxone hydrochloride TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20141211 NDA NDA204242 Orexo US, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8.6; 2.1 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 54131-001_77e6a1f0-9841-435e-b35d-71cf148a04c6 54131-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19630101 UNAPPROVED MEDICAL GAS Del Rio Welders Equipment, Inc. OXYGEN 99 L/100L N 20181231 54136-030_0e6f7207-9085-4a0c-9da8-5611ba1c1cb6 54136-030 HUMAN OTC DRUG Acure Mineral Protection Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20121125 OTC MONOGRAPH NOT FINAL part352 Better Planet Brands TITANIUM DIOXIDE; ZINC OXIDE 9; 3 g/100g; g/100g E 20171231 54144-001_732bbe1a-fa3e-4573-825a-4ea81b9bb159 54144-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830101 NDA NDA205889 Mon HealthCare OXYGEN 990 mL/L N 20181231 54146-0001_831843ea-b3fb-405a-a661-3ff1a71fec52 54146-0001 HUMAN OTC DRUG Flu-Cold Echinacea, Arsenicum Album, Baptisia Tinctoria, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lycopodium Clavatum LIQUID ORAL 20130430 UNAPPROVED HOMEOPATHIC Natural Wonders ECHINACEA ANGUSTIFOLIA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 3; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54151-101_78c157ec-598d-4916-9cf2-7e9619f26ca0 54151-101 HUMAN OTC DRUG Ingenue Zinc Oxide CREAM TOPICAL 20120615 OTC MONOGRAPH NOT FINAL part352 Ingenue, LLC ZINC OXIDE 14.5 mg/mL E 20171231 54155-052_7caf8d4b-281d-4fdd-9900-ceab1b768916 54155-052 HUMAN OTC DRUG PO SUM ON MEDICATED MENTHOL OIL TOPICAL 20040510 OTC MONOGRAPH NOT FINAL part348 PO SUM ON MEDICINE FACTORY LIMITED MENTHOL 15 g/100mL N 20181231 54155-053_2ab2af06-7aff-4ce9-95d0-8d33b4818e76 54155-053 HUMAN OTC DRUG PO SUM ON HEALING BALM MENTHOL OINTMENT TOPICAL 20170525 OTC MONOGRAPH NOT FINAL part348 PO SUM ON MEDICINE FACTORY LIMITED MENTHOL 13 g/100g N 20181231 54157-101_e9611377-e62c-4801-a0f2-2a6e87b5af5b 54157-101 HUMAN OTC DRUG MegaFresh Antibacterial Deodorant Triclocarban SOAP TOPICAL 20130304 OTC MONOGRAPH NOT FINAL part333A American Amenities, Inc. TRICLOCARBAN .3 g/100g N 20181231 54157-102_1e9bad2c-9dd6-43ba-af20-9e7865d450ad 54157-102 HUMAN OTC DRUG MegaFresh SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20131104 OTC MONOGRAPH FINAL part355 American Amenities, Inc. SODIUM FLUORIDE .1 g/100g N 20181231 54157-103_def7e93e-088f-45ca-90bd-8146eda23abb 54157-103 HUMAN OTC DRUG MegaFresh Fluoride Tooth SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131104 OTC MONOGRAPH FINAL part355 American Amenities, Inc. SODIUM MONOFLUOROPHOSPHATE .1 g/100g N 20181231 54157-104_b64481d2-6ade-4eeb-b267-667e1085f1c0 54157-104 HUMAN OTC DRUG MegaFresh SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20140511 OTC MONOGRAPH FINAL part355 American Amenities, Inc. SODIUM FLUORIDE .15 g/100g N 20181231 54157-105_c3a3082d-477f-4bda-93a1-8421efdf6124 54157-105 HUMAN OTC DRUG MegaFresh Hand Sanitizer ALCOHOL LIQUID TOPICAL 20140816 OTC MONOGRAPH NOT FINAL part333E American Amenities, Inc. ALCOHOL 62 mL/100mL N 20181231 54157-106_358431b6-e659-4394-bdb7-f81c1fce71d6 54157-106 HUMAN OTC DRUG MegaFresh Clear Gel Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20141106 OTC MONOGRAPH FINAL part350 American Amenities, Inc. ALUMINUM CHLOROHYDRATE 4.5 g/100mL N 20181231 54157-107_23715e60-6878-4985-a9e6-8c0e513644b8 54157-107 HUMAN OTC DRUG MegaFresh Antiperspirant Roll-on Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20151230 OTC MONOGRAPH FINAL part350 American Amenities, Inc. ALUMINUM CHLOROHYDRATE 4.5 g/100mL N 20181231 54157-108_e2a1fbd5-d2e1-4ae0-b24f-47e8e0da6396 54157-108 HUMAN OTC DRUG UPC 801803 00203 MegaFresh Fluoride Tooth SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20170603 OTC MONOGRAPH FINAL part355 American Amenities, Inc. SODIUM MONOFLUOROPHOSPHATE .1 g/100g N 20181231 54157-109_298788aa-35a5-48f2-acad-c2187917f047 54157-109 HUMAN OTC DRUG UPC 801803 00211 MegaFresh Gel Fluoride Tooth SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20170603 OTC MONOGRAPH FINAL part355 American Amenities, Inc. SODIUM FLUORIDE .1 g/100g N 20181231 54162-000_e37ddd8c-354b-4f6e-b3a8-fb877c05fb72 54162-000 HUMAN OTC DRUG Vitamin A and D Vitamin A and D OINTMENT TOPICAL 20150731 OTC MONOGRAPH FINAL part347 Geritrex LLC PETROLATUM 30.8 g/56g N 20191231 54162-002_4b241791-cd3a-4b8b-b66a-61bb758bcf47 54162-002 HUMAN OTC DRUG Berri-Freez Menthol SPRAY TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part348 Geritrex LLC MENTHOL 11.8 g/118mL N 20181231 54162-004_07ec9909-4eb5-4fb6-90c5-f1e668d5ac43 54162-004 HUMAN OTC DRUG Hemorrhoidal Hygiene pads witch hazel SOLUTION RECTAL 20150731 OTC MONOGRAPH FINAL part346 Geritrex LLC WITCH HAZEL 50 g/100mL N 20181231 54162-004_cc9dc260-c536-4243-ae51-20268281f1e4 54162-004 HUMAN OTC DRUG Hemorrhoidal Hygiene pads witch hazel RINSE RECTAL 20120302 OTC MONOGRAPH NOT FINAL part347 Geritrex Corp. WITCH HAZEL 50 mL/100mL N 20181231 54162-006_63a99d4b-5b19-41c8-88d8-6582011e4ec7 54162-006 HUMAN OTC DRUG BISACODYL BISACODYL SUPPOSITORY RECTAL 20120223 OTC MONOGRAPH NOT FINAL part334 Geritrex Corp. BISACODYL .01 g/2g E 20171231 54162-006_a78bd90b-68ba-4e55-90fa-683f377f0295 54162-006 HUMAN OTC DRUG BISACODYL BISACODYL SUPPOSITORY RECTAL 20150731 OTC MONOGRAPH NOT FINAL part334 Geritrex LLC BISACODYL .01 g/2g E 20171231 54162-007_382a9b02-c436-4cf1-924a-fa3f391d6122 54162-007 HUMAN OTC DRUG SENNA SENNOSIDES A AND B LIQUID ORAL 20120619 OTC MONOGRAPH NOT FINAL part334 Geritrex LLC SENNOSIDES A AND B 415.36 mg/236mL N 20181231 54162-008_f4751767-ac85-4c8a-a569-f7fbe0bbd2ed 54162-008 HUMAN OTC DRUG Berri-Freez Plus Menthol, Camphor, Methyl Salicylate GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part348 Geritrex LLC MENTHOL; CAMPHOR (SYNTHETIC); METHYL SALICYLATE 4.52; .226; 9.04 g/113g; g/113g; g/113g E 20171231 54162-009_d12523bd-332d-4b19-b05f-0a4a2f3b5c86 54162-009 HUMAN OTC DRUG Berri-Freez MENTHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part348 Geritrex LLC MENTHOL 5.085 g/113g N 20181231 54162-010_3eb26aa8-ea5a-4509-8694-a5fd15006a36 54162-010 HUMAN OTC DRUG Asper-Flex Cream Trolamine Salicylate CREAM TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part348 Geritrex LLC TROLAMINE SALICYLATE 8.5 g/85g N 20181231 54162-011_80c8b75b-db66-4fc2-b666-7e1aa63a3b07 54162-011 HUMAN OTC DRUG Dibucaine Dibucaine OINTMENT TOPICAL 20150731 OTC MONOGRAPH FINAL part346 GERITREX LLC DIBUCAINE .28 g/28g N 20181231 54162-017_e9705790-82fd-4d43-9438-5a3e88ba9a67 54162-017 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20140515 OTC MONOGRAPH FINAL part333B GERITREX LLC BACITRACIN ZINC 500 [iU]/g N 20191231 54162-018_ce329877-f502-4829-8609-553bc3259aa1 54162-018 HUMAN OTC DRUG CLOTRIMAZOLE CLOTRIMAZOLE CREAM TOPICAL 20140729 OTC MONOGRAPH FINAL part333C Geritrex Corp CLOTRIMAZOLE 1 g/100g E 20171231 54162-019_79486277-a36d-46e7-92c0-27741ad8b697 54162-019 HUMAN OTC DRUG Benzoyl Peroxide Benzoyl Peroxide GEL TOPICAL 20150731 OTC MONOGRAPH FINAL part333D GERITREX LLC BENZOYL PEROXIDE 10 g/100g N 20181231 54162-044_59f83f77-c625-4bbc-bca0-2595fd3e2730 54162-044 HUMAN OTC DRUG Hemorrhoidal Mineral Oil, Petrolatum, Phenylephrine OINTMENT TOPICAL 20150731 OTC MONOGRAPH FINAL part346 Geritrex LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 7.98; 40.983; .1425 g/57g; g/57g; g/57g N 20181231 54162-045_5a2ce02c-f1fe-47e5-97ab-1b9ecbe45151 54162-045 HUMAN OTC DRUG HEMORRHOIDAL HEMORRHOIDAL SUPPOSITORY RECTAL 20120229 OTC MONOGRAPH FINAL part346 Geritrex Corp. PHENYLEPHRINE HYDROCHLORIDE; COCOA BUTTER .25; 85.5 g/100g; g/100g E 20171231 54162-080_75823050-801c-45ad-bf95-338c08f6c3d4 54162-080 HUMAN OTC DRUG Triple Antibiotic GRX Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20171201 OTC MONOGRAPH FINAL part333B Geritrex LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 54162-099_5f075dba-c590-41bc-979d-5c69c93a8a16 54162-099 HUMAN OTC DRUG Benz Protect BENZOIN RESIN LIQUID TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part356 Geritrex LLC BENZOIN RESIN 100 mg/mL N 20181231 54162-100_e89b0485-f044-4ed2-bf0f-ad85460d8bc2 54162-100 HUMAN OTC DRUG Benzoin Compound Tincture BENZOIN RESIN LIQUID TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part356 Geritrex LLC BENZOIN RESIN 100 mg/mL N 20191231 54162-107_99125a34-3368-49d7-b147-819b7d5dae3c 54162-107 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20140723 OTC MONOGRAPH FINAL part333B GERITREX CORP BACITRACIN ZINC 500 [iU]/g E 20171231 54162-175_e37fe39a-b729-4e3c-9f79-e1f50f6c74d4 54162-175 HUMAN OTC DRUG Mineral oil Mineral oil OIL RECTAL 20150731 OTC MONOGRAPH NOT FINAL part334 GERITREX LLC MINERAL OIL 100 g/100g N 20181231 54162-185_5be2d8d7-48ff-4823-86cb-b34068e8821a 54162-185 HUMAN OTC DRUG Mineral oil Light, N.F Mineral oil OIL TOPICAL 20150731 OTC MONOGRAPH FINAL part347 GERITREX LLC MINERAL OIL 471.99 g/472mL N 20181231 54162-190_a4e408f8-e32c-4000-aa70-b0c5f0181b42 54162-190 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL 20150731 OTC MONOGRAPH NOT FINAL part334 Geritrex LLC MINERAL OIL 471.9528 g/472mL N 20181231 54162-195_6b770ed5-fd3f-4797-a693-6724b73c7758 54162-195 HUMAN OTC DRUG Docusate Sodium Liquid Docusate sodium LIQUID ORAL 20170928 OTC MONOGRAPH NOT FINAL part334 Geritrex LLC DOCUSATE SODIUM 50 mg/5mL N 20181231 54162-200_fea138a7-b4da-45c8-bd53-815bc27aabea 54162-200 HUMAN OTC DRUG PC-TAR Coal Tar SHAMPOO TOPICAL 20150731 OTC MONOGRAPH FINAL part358H Geritrex LLC COAL TAR 1.77441 g/177.441mL N 20181231 54162-219_8e3d4a50-2206-4132-890c-9c08296e62bb 54162-219 HUMAN OTC DRUG Calmodrox Menthol, Zinc Oxide OINTMENT TOPICAL 20150122 OTC MONOGRAPH FINAL part347 Geritrex Corp MENTHOL; ZINC OXIDE .44; 20 g/100g; g/100g E 20171231 54162-220_f4238cc8-536d-4900-ae6e-ddb3b3cc9fbb 54162-220 HUMAN OTC DRUG Dermadrox Zinc Acetate SPRAY TOPICAL 20150731 OTC MONOGRAPH FINAL part347 Geritrex LLC ZINC ACETATE .531 g/118mL N 20181231 54162-221_31e3fc58-0d5f-492f-b1f7-2e738c51a7f9 54162-221 HUMAN OTC DRUG Dermadrox Aluminum Hydroxide OINTMENT TOPICAL 20131015 OTC MONOGRAPH FINAL part347 GERITREX LLC ALUMINUM HYDROXIDE 1.356 g/113g N 20181231 54162-221_e9a97d88-96fc-4ea0-9482-524aac47716f 54162-221 HUMAN OTC DRUG Dermadrox Aluminum Hydroxide OINTMENT TOPICAL 20150731 OTC MONOGRAPH FINAL part347 GERITREX LLC ALUMINUM HYDROXIDE 1.356 g/113g N 20181231 54162-229_5977ea44-7dbe-476e-9691-421d2b5d14f6 54162-229 HUMAN OTC DRUG Caladrox Menthol, Zinc Oxide OINTMENT TOPICAL 20150929 OTC MONOGRAPH FINAL part347 Geritrex LLC MENTHOL; ZINC OXIDE .44; 20 g/100g; g/100g N 20181231 54162-250_159e9ddd-d861-453b-8bf0-c2a0d603fd7c 54162-250 HUMAN OTC DRUG Tera-Gel COAL TAR SHAMPOO TOPICAL 20150731 OTC MONOGRAPH FINAL part358H Geritrex LLC COAL TAR .57 g/114mL N 20181231 54162-250_a690acc1-0906-411d-bb5b-16ce09797278 54162-250 HUMAN OTC DRUG Tera-Gel COAL TAR SHAMPOO TOPICAL 20150731 OTC MONOGRAPH FINAL part358H Geritrex LLC COAL TAR 1.365 g/237mL N 20181231 54162-268_c5de7b12-7ebb-4030-87fc-7f0df2442ab0 54162-268 HUMAN OTC DRUG GRx Dyne Scrub POVIDONE-IODINE SOLUTION TOPICAL 20120703 OTC MONOGRAPH NOT FINAL part333A Geritrex Corp. POVIDONE-IODINE 7500 mg/100mL E 20171231 54162-269_75ffc2d3-b014-4e28-a7ae-76b61646f8e1 54162-269 HUMAN OTC DRUG GRx Dyne Povidone Iodine SOLUTION TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part333A Geritrex Corp. POVIDONE-IODINE 10 mL/100mL E 20171231 54162-269_f20e255c-14cc-4eab-a72b-90000cc0a45b 54162-269 HUMAN OTC DRUG GRx Dyne Povidone Iodine SOLUTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part333A Geritrex Corp. POVIDONE-IODINE 10 mL/100mL E 20171231 54162-375_c8088435-5ade-4346-8737-171afe638e48 54162-375 HUMAN OTC DRUG CleanZing Cetylpyridium Chloride SOLUTION ORAL 20150731 OTC MONOGRAPH NOT FINAL part356 Geritrex LLC CETYLPYRIDINIUM CHLORIDE .283 g/473mL E 20171231 54162-450_bdbc592f-23ef-4143-ab06-f257f2952cfa 54162-450 HUMAN OTC DRUG Vaporx Balm Camphor, Eucalyptus Oil, Menthol OINTMENT TOPICAL 20151229 OTC MONOGRAPH FINAL part341 Geritrex LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 2.4; .6; 1.3 g/50g; g/50g; g/50g E 20171231 54162-500_26e14d63-7dc4-4663-a974-cacf755724b4 54162-500 HUMAN OTC DRUG Hydrophor Petrolatum OINTMENT TOPICAL 20150731 OTC MONOGRAPH FINAL part347 Geritrex LLC PETROLATUM 42 g/100g N 20191231 54162-500_83041600-dd68-4f97-b97a-3931eb2ab3c9 54162-500 HUMAN OTC DRUG Hydrophor Petrolatum OINTMENT TOPICAL 20150731 OTC MONOGRAPH FINAL part347 Geritrex LLC PETROLATUM 42 g/100g N 20191231 54162-540_c2b7282b-6a7c-4344-9694-a72ccc386c36 54162-540 HUMAN OTC DRUG KERATEK MENTHOL, METHYL SALICYLATE GEL TOPICAL 20131021 OTC MONOGRAPH NOT FINAL part348 GERITREX CORP MENTHOL; METHYL SALICYLATE 16; 28 g/100g; g/100g E 20171231 54162-550_9c14173f-4f71-4b34-aeef-13a9e1415814 54162-550 HUMAN OTC DRUG Men-Phor Menthol, Camphor LOTION TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part348 Geritrex LLC MENTHOL; CAMPHOR (SYNTHETIC) 1.11; 1.11 g/222mL; g/222mL N 20191231 54162-555_9434542d-dd5a-47a9-b4be-c820fb7f27bd 54162-555 HUMAN OTC DRUG Analgesic Balm Analgesic Balm OINTMENT TOPICAL 20120309 OTC MONOGRAPH NOT FINAL part348 Geritrex LLC MENTHOL; METHYL SALICYLATE 1.74; 4.06 g/29g; g/29g N 20181231 54162-560_efeb5c71-df19-48b3-8c85-eb5d22e99df7 54162-560 HUMAN OTC DRUG REME D Menthol, Capsaicin PATCH TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part348 Geritrex Corp MENTHOL; CAPSAICIN 5; .025 g/100g; g/100g E 20171231 54162-597_b81b8f2f-dde7-4e1e-af1d-820bc7377126 54162-597 HUMAN OTC DRUG White Petrolatum White Petrolatum OINTMENT TOPICAL 20150731 OTC MONOGRAPH FINAL part347 Geritrex LLC PETROLATUM 100 g/100g N 20181231 54162-650_ebe2c61c-a077-4a24-94bb-7af55fb3a15a 54162-650 HUMAN OTC DRUG Geri Protect Petrolatum OINTMENT TOPICAL 20150731 OTC MONOGRAPH FINAL part347 Geritrex LLC PETROLATUM 87.32 g/118g E 20171231 54162-700_f0aa7245-b91f-499c-b009-77b00e41c9c8 54162-700 HUMAN OTC DRUG Sorbitol Sorbitol SOLUTION ORAL 20120717 OTC MONOGRAPH NOT FINAL part334 Geritrex LLC SORBITOL 258.2 g/474mL N 20191231 54162-925_2020e17e-7b52-4104-827c-045bde3c7e04 54162-925 HUMAN OTC DRUG Benz O Sthetic Benzocaine SPRAY TOPICAL 20120213 OTC MONOGRAPH NOT FINAL part348 Geritrex Corp. BENZOCAINE 20 mL/100mL E 20171231 54162-926_cefa9270-3af2-4ca8-8684-9647d4a0326c 54162-926 HUMAN OTC DRUG Benz O Sthetic Benzocaine GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part356 Geritrex LLC BENZOCAINE 20 g/100g N 20181231 54162-929_fc3e9b98-1785-4154-ae14-62baa8fff25f 54162-929 HUMAN OTC DRUG Benz O Sthetic Benzocaine SPRAY TOPICAL 20170630 OTC MONOGRAPH NOT FINAL part348 Geritrex LLC BENZOCAINE 11.8 g/59mL N 20181231 54170-100_6ecd6325-e34c-4b79-b956-91ad98544b2f 54170-100 HUMAN OTC DRUG NANOMIX NANO CLEAN Witch hazel SOAP TOPICAL 20120901 OTC MONOGRAPH FINAL part347 NANOPOLY CO., LTD. WITCH HAZEL .001 g/100g N 20181231 54170-110_710ea658-8254-49a4-97c7-434f8f8769bb 54170-110 HUMAN OTC DRUG NANOMIX BODY CARE Dimethicone LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part347 NANOPOLY CO., LTD. DIMETHICONE 4.8 mg/400mL N 20181231 54170-120_0462ccf8-8bcc-494d-bab5-55821a082bc1 54170-120 HUMAN OTC DRUG NANOMIX NANO CLEAN Skin Protectant Antibacterial Function Allantoin SOAP TOPICAL 20130701 OTC MONOGRAPH FINAL part347 NANOPOLY CO., LTD. ALLANTOIN .6 g/100g N 20181231 54170-130_159a304b-2122-4957-acb6-8bec2d094f0b 54170-130 HUMAN OTC DRUG SEUK Allantoin SOAP TOPICAL 20140201 OTC MONOGRAPH FINAL part347 NANOPOLY CO., LTD. ALLANTOIN .6 g/100g N 20181231 54181-001_4590b307-7205-4547-9fd2-7665b788566f 54181-001 HUMAN OTC DRUG GUINOT Skin Defense SPF 15 Face OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130311 OTC MONOGRAPH NOT FINAL part352 Guinot SAS OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 60; 50; 40; 11 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 54181-004_02f8ab3e-ca54-42f0-8bd3-6d295e0c3449 54181-004 HUMAN OTC DRUG GUINOT Large Defense uv Medium protection Sunscreen for the body SPF 20 AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20140102 OTC MONOGRAPH NOT FINAL part352 Guinot SAS AVOBENZONE; HOMOSALATE; OCTOCRYLENE 29; 120; 27 mg/mL; mg/mL; mg/mL N 20181231 54181-006_3839df17-7ef9-136e-e054-00144ff8d46c 54181-006 HUMAN OTC DRUG Hydra Finish SPF 15 HOMOSALATE, OCTINOXATE CREAM TOPICAL 20160722 OTC MONOGRAPH NOT FINAL part352 Guinot HOMOSALATE; OCTINOXATE 40; 60 mg/mL; mg/mL N 20181231 54182-001_161a374b-5a8b-4a1c-98ca-ce250c85c76f 54182-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140919 UNAPPROVED MEDICAL GAS HRC Healthcare LLC OXYGEN 99 L/100L E 20171231 54188-003_b1752d02-08d5-4bb9-993b-713085f6adba 54188-003 HUMAN OTC DRUG WONG LOP KONG MEDICATED CAMPHOR OIL TOPICAL 20040329 OTC MONOGRAPH NOT FINAL part348 WONG LAP KWONG MEDICINE COMPANY LIMITED CAMPHOR (SYNTHETIC) 4 g/100mL N 20181231 54194-268_166348ec-f7f7-419b-bdee-0a62e73d948d 54194-268 HUMAN OTC DRUG ariSulfur Acne Treatment Sulfur SOAP TOPICAL 20130528 OTC MONOGRAPH FINAL part333D A+Plus Medical Center Limited SULFUR 10 g/100g N 20181231 54202-001_a891d816-59d5-4f65-8314-c7c4ce8b5ec6 54202-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS All Saints Home Medical OXYGEN 99 L/100L N 20181231 54218-400_490a66e9-8acb-4a1f-bc61-96d0354ce226 54218-400 HUMAN PRESCRIPTION DRUG AIR COMPRESSED AIR COMPRESSED (MEDICAL AIR USP) GAS RESPIRATORY (INHALATION) 19700101 UNAPPROVED MEDICAL GAS United States Welding, Inc. OXYGEN 20 L/100L E 20171231 54218-500_6a2a9ba0-6369-4762-925b-873bab22c749 54218-500 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19700101 NDA NDA205767 United States Welding, Inc. OXYGEN 99 L/100L N 20191231 54218-600_337a1444-9b21-406f-86de-a299652192f6 54218-600 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19700101 UNAPPROVED MEDICAL GAS United States Welding, Inc. NITROGEN 99 L/100L E 20171231 54218-800_6c87395f-075a-4c60-a28d-b075d00a3644 54218-800 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19700101 UNAPPROVED MEDICAL GAS United States Welding, Inc. NITROUS OXIDE 99 kg/100kg E 20171231 54230-356_ed0737fc-eb28-4b0b-b9b4-ac368ebe4bb9 54230-356 HUMAN OTC DRUG Celadrin Joint and Muscle Pain Relieving Menthol CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part348 Factors Group of Nutritional Products MENTHOL 12.5 mg/g N 20181231 54235-204_3a7bcc23-ab3d-4cfd-a50b-6a53cd8cdb37 54235-204 HUMAN OTC DRUG Protectyl soleil moisturizing sunscreen lotion high protection spf 30 Titanium Dioxide, Octinoxate and Octocrylene CREAM TOPICAL 20070501 OTC MONOGRAPH FINAL part352 Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 7; 8.4 mL/100mL; mL/100mL; mL/100mL E 20171231 54235-205_eb6995ae-7264-4fad-8a61-b15109f35c96 54235-205 HUMAN OTC DRUG FRAICHEUR VERVEINE ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20080701 OTC MONOGRAPH FINAL part350 Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL E 20171231 54235-206_1d956d33-7cdc-4c7d-8eea-20c418778f97 54235-206 HUMAN OTC DRUG FRAICHEUR CEDRE BLEU ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20081001 OTC MONOGRAPH FINAL part350 Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL E 20171231 54235-207_ef7c70ec-2036-49bd-a429-823855e607f2 54235-207 HUMAN OTC DRUG FRAICHEUR THE VERT ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20081001 OTC MONOGRAPH FINAL part350 Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL E 20171231 54235-208_c74d09ec-f385-4277-a4c5-8fe2bda3d914 54235-208 HUMAN OTC DRUG FRAICHEUR BAMBOU ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20081001 OTC MONOGRAPH FINAL part350 Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL E 20171231 54235-209_96b0cc1c-1c15-4e16-93e1-592093074a8e 54235-209 HUMAN OTC DRUG FRAICHEUR CHEVREFEUILLE ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20090201 OTC MONOGRAPH FINAL part350 Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL E 20171231 54247-001_f15fc2df-8058-49d5-8342-7d68bff09287 54247-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850101 NDA NDA205849 Bishop Welding Supply OXYGEN 995 mL/L N 20181231 54256-008_32222c4c-c04b-4728-8a22-5e45d844e34c 54256-008 HUMAN OTC DRUG Firmus Bacillus firmus CAPSULE ORAL 20151010 UNAPPROVED HOMEOPATHIC BioResource Inc. BACILLUS FIRMUS 6 [hp_X]/1 E 20171231 54256-029_7bc68ac3-9b17-490e-bd6b-57ba94753ea1 54256-029 HUMAN OTC DRUG Aspergillus Aspergillus Niger Var. Niger SUPPOSITORY RECTAL 20151010 UNAPPROVED HOMEOPATHIC BioResource Inc. ASPERGILLUS NIGER VAR. NIGER 3 [hp_X]/1 E 20171231 54256-039_89e2c133-34fb-4ac1-8204-23895521b5a4 54256-039 HUMAN OTC DRUG Notatum PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM SUPPOSITORY RECTAL 20010101 UNAPPROVED HOMEOPATHIC BioResource Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 3 [hp_X]/1 E 20171231 54256-040_9e359943-2741-4d63-a236-72187e326ffa 54256-040 HUMAN OTC DRUG Notatum Penicillium Chrysogenum Var. Chrysogenum LIQUID ORAL 20160101 UNAPPROVED HOMEOPATHIC BioResource Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [hp_X]/10mL E 20171231 54256-046_6998060c-d0a7-49b7-917a-7456e6f2637c 54256-046 HUMAN OTC DRUG Notatum-Quentans Nasal 4X Penicillium Chrysogenum Var. Chrysogenum and Penicillium Glabrum SPRAY NASAL 20160101 UNAPPROVED HOMEOPATHIC BioResource Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM 4; 4 [hp_X]/10mL; [hp_X]/10mL E 20171231 54256-057_14e9c24e-d175-4000-998d-8d7240caaec4 54256-057 HUMAN OTC DRUG Thuja Thuja occidentalis leafy twig LIQUID ORAL 20050501 UNAPPROVED HOMEOPATHIC BioResource Inc. THUJA OCCIDENTALIS LEAFY TWIG 3 [hp_X]/50mL E 20171231 54256-099_52359708-5c43-441f-b496-16896351b85f 54256-099 HUMAN OTC DRUG Candida Candida parapsilosis SPRAY NASAL 20160801 UNAPPROVED HOMEOPATHIC BioResource Inc. CANDIDA PARAPSILOSIS 4 [hp_X]/15mL E 20171231 54256-201_decc69c2-600e-464a-8b3d-2fb3d195dc3a 54256-201 HUMAN OTC DRUG BOLYM-EX Drops Benzoic Acid, Formic Acid, Aristolochia Clematitis Root, Asafetida, Avena Sativa Flowering Top, Berberis Vulgaris Root Bark, Calcium Phosphate, Capsella bursa-pastoris, Galium aparine, Daphne Mezereum Bark, and Piper Methysticum Root LIQUID ORAL 20150601 UNAPPROVED HOMEOPATHIC BioResource Inc. BENZOIC ACID; FORMIC ACID; ARISTOLOCHIA CLEMATITIS ROOT; ASAFETIDA; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CALCIUM PHOSPHATE; CAPSELLA BURSA-PASTORIS; GALIUM APARINE; DAPHNE MEZEREUM BARK; PIPER METHYSTICUM ROOT 5; 5; 24; 5; 4; 5; 8; 5; 5; 8; 10 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL E 20171231 54257-001_140073ad-3153-41f4-b6a3-8a606e35f435 54257-001 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20150115 ANDA ANDA202039 Magno-Humphries Labs, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 54257-180_288b0ce9-2b58-4630-8896-07bca34ecc0c 54257-180 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20160426 ANDA ANDA206531 Magno-Humphries, Inc. FAMOTIDINE 10 mg/1 N 20181231 54257-277_60e048ec-2f2a-5ef6-e053-2a91aa0a564e 54257-277 HUMAN OTC DRUG Mucosa DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN TABLET ORAL 20170404 OTC MONOGRAPH FINAL part341 Magno-Humphries, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 54257-790_60e04a25-ea7d-0a2b-e053-2991aa0ad727 54257-790 HUMAN OTC DRUG Fiber Laxative Calcium Polycarbophil CALCIUM POLYCARBOPHIL TABLET ORAL 20170404 OTC MONOGRAPH NOT FINAL part334 Magno-Humphries, Inc. CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 54257-802_9c8ffdcd-a0dc-4cac-a7b8-dab6df54d023 54257-802 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20160426 ANDA ANDA206531 Magno-Humphries, Inc. FAMOTIDINE 20 mg/1 N 20181231 54257-902_60e048c6-f7ee-877b-e053-2a91aa0a59af 54257-902 HUMAN OTC DRUG Stool Softener Docusate Sodium DOCUSATE SODIUM CAPSULE, GELATIN COATED ORAL 20170404 OTC MONOGRAPH NOT FINAL part334 Magno-Humphries, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 54260-001_ed0fe835-da0e-4f37-98b9-76ca24bfc5f3 54260-001 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19000101 NDA NDA206009 Nitrous Oxide NITROUS OXIDE 990 mL/L N 20181231 54272-101_fcec509a-08a3-4af1-90ef-a79bf01e3ec3 54272-101 HUMAN OTC DRUG ACNE CORRECTING CLEANSER SALICYLIC ACID GEL TOPICAL 20130221 OTC MONOGRAPH FINAL part333D CEN BEAUTY LLC SALICYLIC ACID 2 g/100mL E 20171231 54272-102_59df130f-70ef-4fad-aadc-01b7de555952 54272-102 HUMAN OTC DRUG BLEMISH CORRECTING SERUM BENZOYL PEROXIDE GEL TOPICAL 20130221 OTC MONOGRAPH FINAL part333D CEN BEAUTY LLC BENZOYL PEROXIDE 5 g/100mL E 20171231 54272-103_27fdba83-576d-4d5c-8bd5-f61967fb62b3 54272-103 HUMAN OTC DRUG BLEMISH CORRECTING SERUM SENSITIVE SALICYLIC ACID GEL TOPICAL 20130221 OTC MONOGRAPH FINAL part333D CEN BEAUTY LLC SALICYLIC ACID 2 g/100mL E 20171231 54272-201_ec0b39fc-fb2a-4269-b9c8-77deed734b95 54272-201 HUMAN OTC DRUG BRIGHTEN SPF 30 ZINC OXIDE OCTINOXATE CREAM TOPICAL 20130221 OTC MONOGRAPH FINAL part352 CEN BEAUTY LLC ZINC OXIDE; OCTINOXATE 15; 6 g/100mL; g/100mL E 20171231 54272-202_03661a43-9815-4aeb-b1e4-2b9ad491f3c1 54272-202 HUMAN OTC DRUG FIRMING DAY SPF 30 ZINC OXIDE OCTINOXATE CREAM TOPICAL 20130221 OTC MONOGRAPH FINAL part352 CEN BEAUTY LLC ZINC OXIDE; OCTINOXATE 15; 6 g/100mL; g/100mL E 20171231 54272-301_2d9bf516-a130-4aaf-8efb-600250a7236d 54272-301 HUMAN OTC DRUG BRIGHTEN LIGHTENING HYDROQUINONE GEL TOPICAL 20130221 OTC MONOGRAPH NOT FINAL part358A CEN BEAUTY LLC HYDROQUINONE 2 g/100mL E 20171231 54273-001_2d674b60-f3e5-40c5-8a4d-991c5fbb65b4 54273-001 HUMAN OTC DRUG ZIMS MAX HEAT METHYL SALICYLATE LIQUID TOPICAL 20170815 OTC MONOGRAPH NOT FINAL part348 KOBAYASHI Healthcare International, Inc. METHYL SALICYLATE 200 mg/g N 20181231 54273-002_7e623db4-b381-4838-b6a5-30714668b369 54273-002 HUMAN OTC DRUG ZIMS MAX FREEZE MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part348 KOBAYASHI Healthcare International, Inc. MENTHOL, UNSPECIFIED FORM 37 mg/g N 20181231 54273-003_90666db7-64b6-4153-8881-ff7495092bdd 54273-003 HUMAN OTC DRUG ZIMS MAX FREEZE MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part348 KOBAYASHI Healthcare International, Inc. MENTHOL, UNSPECIFIED FORM 37 mg/g N 20181231 54273-004_411705b4-1c51-419f-81ae-0033fad35348 54273-004 HUMAN OTC DRUG ZIMS MAX FREEZE MENTHOL, UNSPECIFIED FORM SPRAY TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part348 KOBAYASHI Healthcare International, Inc. MENTHOL, UNSPECIFIED FORM 37 mg/g N 20181231 54273-005_8ad2203c-7f9f-4b87-837e-454c7059e1ef 54273-005 HUMAN OTC DRUG ZIMS MAX ARNICA HOMEOPATHIC aloe vera leaf, arnica montana, calendula officinalis flower, and bellis perennis GEL TOPICAL 20180101 UNAPPROVED HOMEOPATHIC KOBAYASHI Healthcare International, Inc. ALOE VERA LEAF; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWER; BELLIS PERENNIS 3; 1; 3; 4 [hp_X]/3mL; [hp_X]/3mL; [hp_X]/3mL; [hp_X]/3mL N 20181231 54288-103_84706660-ee8c-4c7b-9bea-ea60ece02b61 54288-103 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140808 NDA NDA205029 BPI Labs, LLC EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 54288-131_a03faba1-e4b5-4c21-988a-64dbcf0d6a61 54288-131 HUMAN PRESCRIPTION DRUG FENOPROFEN CALCIUM FENOPROFEN CALCIUM CAPSULE ORAL 20160706 NDA NDA017604 BPI Labs LLC FENOPROFEN CALCIUM 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54288-132_a03faba1-e4b5-4c21-988a-64dbcf0d6a61 54288-132 HUMAN PRESCRIPTION DRUG FENOPROFEN CALCIUM FENOPROFEN CALCIUM CAPSULE ORAL 20160706 NDA NDA017604 BPI Labs LLC FENOPROFEN CALCIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54291-021_2e322fea-3974-3db5-e054-00144ff8d46c 54291-021 HUMAN OTC DRUG HealthCare Plus Alcohol Swabs SWAB TOPICAL 20091005 20190228 OTC MONOGRAPH NOT FINAL part333A Canadian Custom Packaging Company ISOPROPYL ALCOHOL .7 mL/1 E 20171231 54295-301_39f93cd6-05bf-4eb6-8736-4346561d8447 54295-301 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 9 Sulfur 4.5 Wash Sulfacetamide Sodium and Sulfur RINSE TOPICAL 20121210 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 9; 4.5 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 54295-302_aa82c73c-e094-46a9-9d16-4a1201d4857b 54295-302 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID CREAM TOPICAL 20121210 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC SALICYLIC ACID 60 mg/g E 20171231 54295-303_d260115b-606e-45f6-bee5-6dd44b36c9e4 54295-303 HUMAN PRESCRIPTION DRUG SALICYLIC ACID SALICYLIC ACID LOTION TOPICAL 20121210 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC SALICYLIC ACID 60 mg/g E 20171231 54295-304_32eeeb54-937e-487a-b260-7425e5b176dd 54295-304 HUMAN PRESCRIPTION DRUG Salicylic Acid salicylic acid SOLUTION TOPICAL 20131116 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC SALICYLIC ACID 275 mg/mL E 20171231 54295-307_0b012ab1-6a8d-4159-94bf-3397bf10244d 54295-307 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium, Sulfur Sulfacetamide Sodium, Sulfur LOTION TOPICAL 20130701 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 100; 50 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 54295-308_ea63c523-8d30-4fb5-9b0c-c0a2c1dfa350 54295-308 HUMAN PRESCRIPTION DRUG UREA UREA CREAM TOPICAL 20140901 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC UREA 40 g/100g N 20181231 54295-311_a3ec6a2f-6807-4fb3-9bb0-5d120670ad2c 54295-311 HUMAN PRESCRIPTION DRUG UREA UREA CREAM TOPICAL 20131202 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC UREA 39 g/100g N 20181231 54295-312_2c978f35-4f13-4ca2-bf29-b42498f2ba8d 54295-312 HUMAN PRESCRIPTION DRUG UREA UREA LOTION TOPICAL 20140919 UNAPPROVED DRUG OTHER Trinity Pharmaceuticals, LLC UREA 40 g/100g N 20181231 54296-1001_93c5e396-0dac-4c3d-9b3e-fc24a42b44b9 54296-1001 HUMAN OTC DRUG JEUNCELL a drug for atopic dermatitis RUMEX CRISPUS WHOLE LIQUID TOPICAL 20121125 UNAPPROVED DRUG OTHER Jeun Cell Ltd RUMEX CRISPUS WHOLE 5 mg/100mL E 20171231 54296-2001_8f8e9c7b-c488-418f-8bf0-69aca407d2ce 54296-2001 HUMAN OTC DRUG JEUNCELL Hair Loss Prevention and Hair Growth Tonic PINE NEEDLE OIL (PINUS MUGO) LIQUID TOPICAL 20121125 UNAPPROVED DRUG OTHER Jeun Cell Ltd PINE NEEDLE OIL (PINUS MUGO) 5 mg/100mL E 20171231 54296-3001_b047040a-c85b-4c6a-89f2-09ab994b1785 54296-3001 HUMAN OTC DRUG JEUNCELL Hair restorer and Hair Growth Solution NIACIN SHAMPOO TOPICAL 20121125 UNAPPROVED DRUG OTHER Jeun Cell Ltd NIACIN 2 mg/100mL E 20171231 54298-515_d3f5f74d-009b-41cf-b402-b9433fc86994 54298-515 HUMAN OTC DRUG INDUSTRIAL ANTISEPTIC SANITIZER alcohol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 INDUSTRIAL SPECIALTIES, INC. ALCOHOL 600 mL/1000mL E 20171231 54300-0001_6e83dce7-81fd-422e-8c9c-90e9c73e2693 54300-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19920730 UNAPPROVED MEDICAL GAS B&K Home Medical Services, Inc. OXYGEN 99 L/100L E 20171231 54305-102_b9bae301-096d-411d-8ff1-beee0445976c 54305-102 HUMAN OTC DRUG SUGAR FREE LEMON MINT HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola Ag MENTHOL 1.1 mg/1 N 20181231 54305-108_f516307f-c966-47ca-a71d-27b7991e4309 54305-108 HUMAN OTC DRUG NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 2 mg/1 N 20181231 54305-175_80b8a539-c905-40f8-9755-6b4350d15141 54305-175 HUMAN OTC DRUG THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 4.8 mg/1 N 20181231 54305-185_ce21fcd7-b4ff-4106-b152-798672512612 54305-185 HUMAN OTC DRUG MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL LOZENGE ORAL 20150901 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 4.8 mg/1 N 20181231 54305-313_5d76d52d-b2f7-4f81-8c94-7ed04c803c1e 54305-313 HUMAN OTC DRUG DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL LOZENGE ORAL 20110403 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 8.3 mg/1 N 20181231 54305-323_1b9d98f5-b5fe-42dc-ac42-f7d092ef1f6e 54305-323 HUMAN OTC DRUG DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL LOZENGE ORAL 20110403 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 8.3 mg/1 N 20181231 54305-331_4a8c3174-6960-40ce-9dd3-ba0fe672dd8e 54305-331 HUMAN OTC DRUG DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL LOZENGE ORAL 20110403 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 8.5 mg/1 N 20181231 54305-467_c932cab8-eff5-426d-a4c5-c7caa63961b7 54305-467 HUMAN OTC DRUG Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 3.5 mg/1 N 20181231 54305-489_06d3e735-84c4-47e6-bd86-00e9ed1af54b 54305-489 HUMAN OTC DRUG NATURAL LEMON MINT HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola Ag MENTHOL 1.5 mg/1 N 20181231 54305-507_758f6a87-01ad-4811-bf0f-867d1e6f3dd6 54305-507 HUMAN OTC DRUG Natural Cherry Honey Herb Throat Drops MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola Ag MENTHOL 1.8 mg/1 N 20181231 54305-617_a13377c5-ac59-4017-8c5c-92baee61b9c9 54305-617 HUMAN OTC DRUG EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL LOZENGE ORAL 20130527 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 8.3 mg/1 N 20181231 54305-676_7639adf5-f57c-4855-ab51-e7a8a81cb8bc 54305-676 HUMAN OTC DRUG NATURAL LEMON MINT HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola Ag MENTHOL 1.6 mg/1 N 20181231 54305-802_dcfcaacc-8256-4767-84f5-636a75526421 54305-802 HUMAN OTC DRUG SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL LOZENGE ORAL 19420412 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 4.8 mg/1 N 20181231 54305-840_05df77e1-6196-4099-83bc-545a78d82236 54305-840 HUMAN OTC DRUG SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 4.1 mg/1 N 20181231 54305-909_e75b721d-60fb-4ca0-9690-59fc27f0a396 54305-909 HUMAN OTC DRUG Natural Cherry Honey Herb Throat Drops MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola Ag MENTHOL 2 mg/1 N 20181231 54305-923_4cbaf9fc-0aee-4062-bc7f-99e881e0f4e1 54305-923 HUMAN OTC DRUG THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola Ag MENTHOL 5.3 mg/1 N 20181231 54305-976_049f50d7-fa66-4da4-93a4-0651a620f7da 54305-976 HUMAN OTC DRUG SUGAR FREE SWISS CHERRY HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola Ag MENTHOL 2.2 mg/1 N 20181231 54312-019_613fd75d-051a-094f-e053-2991aa0afea1 54312-019 HUMAN OTC DRUG VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC NEOMYCIN SULFATE OINTMENT TOPICAL 20171226 OTC MONOGRAPH FINAL part333B Compania Internacional de Comercio, S.A.P.I de C.V. NEOMYCIN SULFATE 3.5 mg/g N 20181231 54312-125_613ff499-b7e9-5c25-e053-2991aa0ac798 54312-125 HUMAN OTC DRUG Derman Antifungal ZINC UNDECYLENATE CREAM TOPICAL 20171226 OTC MONOGRAPH FINAL part333C Compania Internacional de Comercio, S.A.P.I de C.V. ZINC UNDECYLENATE; UNDECYLENIC ACID 18; 5 g/100g; g/100g N 20181231 54312-270_59247b31-26c7-4d63-bd13-3904bd1738b1 54312-270 HUMAN OTC DRUG AOGel Hand Sanitizer Kids Alcohol GEL TOPICAL 20101014 OTC MONOGRAPH NOT FINAL part333E Compania Internacional de Comercio, S.A. de C.V. ALCOHOL 70 g/100mL E 20171231 54312-275_bf81eca4-4cea-491f-b14c-3ef31c28a1fd 54312-275 HUMAN OTC DRUG AOGel Alcohol GEL TOPICAL 20101122 OTC MONOGRAPH NOT FINAL part333E Compania Internacional de Comercio, S.A. de C.V. ALCOHOL 70 g/100mL E 20171231 54312-275_fc7ed5a3-fff1-4b9e-b62a-6797bd39fedb 54312-275 HUMAN OTC DRUG AOGel Alcohol GEL TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333E Compania Internacional de Comercio, S.A. de C.V. ALCOHOL 70 g/100mL E 20171231 54312-325_1c651bfb-fdd9-4c2e-b5bb-243a1f703e18 54312-325 HUMAN OTC DRUG DERMAN ANTIFUNGAL UNDECYLENIC ACID SPRAY TOPICAL 20131021 OTC MONOGRAPH FINAL part333C Compania Internacional de Comercio, S.A. de C.V. UNDECYLENIC ACID 100 mg/mL N 20181231 54312-525_61407014-c49d-7eb6-e053-2991aa0af436 54312-525 HUMAN OTC DRUG VITACILINA Bebe Diaper Rash ALLANTOIN, ZINC OXIDE OINTMENT TOPICAL 20130930 OTC MONOGRAPH FINAL part347 Compania Internacional de Comercio, S.A.P.I de C.V. ALLANTOIN; ZINC OXIDE 10; 250 mg/g; mg/g N 20181231 54312-825_e53a1ea2-ec19-4028-bbbb-1b2c5f672062 54312-825 HUMAN OTC DRUG Rocainol TOPICAL ANALGESIC METHYL SALICYLATE, MENTHOL OINTMENT TOPICAL 20130930 OTC MONOGRAPH NOT FINAL part348 Compania Internacional de Comercio, S.A. de C.V. METHYL SALICYLATE; MENTHOL 16; 8 g/100g; g/100g N 20181231 54312-925_613ffa66-4f79-5d43-e053-2991aa0a48a7 54312-925 HUMAN OTC DRUG DERMAN ANTIFUNGAL ZINC UNDECYLENATE, UNDECYLENIC ACID POWDER TOPICAL 20130930 OTC MONOGRAPH FINAL part333C Compania Internacional de Comercio, S.A.P.I. de C.V. UNDECYLENIC ACID; ZINC UNDECYLENATE 2; 20 g/100g; g/100g N 20181231 54316-123_5a706f86-67db-4ac9-8345-530b2a26640d 54316-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20000101 NDA NDA205767 Youngstown Oxygen & Welding Supply, Inc. OXYGEN .995 L/L N 20181231 54323-215_33139f1d-ba01-6868-e054-00144ff88e88 54323-215 HUMAN OTC DRUG Flanders Buttocks White petrolatum, zinc oxide OINTMENT TOPICAL 19861016 OTC MONOGRAPH FINAL part347 Flanders Inc PETROLATUM; ZINC OXIDE 66.2; 13.4 g/100g; g/100g N 20181231 54340-003_e7bdbe0b-ad74-484e-9e4b-7718d7992a21 54340-003 HUMAN OTC DRUG Dial For Men Dandruff Control Hair and Body Wash Pyrithione Zinc SOLUTION TOPICAL 20101220 OTC MONOGRAPH FINAL part358H The Dial Corporation PYRITHIONE ZINC .95 g/100g E 20171231 54340-004_6d05f765-e802-4a5a-83f6-c690030776a7 54340-004 HUMAN OTC DRUG Dry Idea Advanced Dry Aluminum Zirconium Pentachlorohydrex Gly LIQUID TOPICAL 20110519 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 16.3 g/100mL E 20171231 54340-005_89f039bf-2ba7-40e0-8376-e18e346cc0b2 54340-005 HUMAN OTC DRUG Dry Idea Advanced Dry-Powder Fresh Aluminum Zirconium Pentachlorohydrex Gly LIQUID TOPICAL 20111018 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 16.3 g/100mL E 20171231 54340-006_6c5638ff-8f91-48a7-99d1-c19df233e15e 54340-006 HUMAN OTC DRUG Dry Idea Advanced Dry-Cotton Dry Aluminum Zirconium Pentachlorohydrex Gly LIQUID TOPICAL 20111119 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 16.3 g/100mL E 20171231 54340-011_7bae8650-976d-4ec5-b0b1-a9161d87908c 54340-011 HUMAN OTC DRUG RG TD5 Inv.Solid Antiperspirant Deodorant Cooling Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20111108 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 2.0944 g/11.9g E 20171231 54340-068_b285a8f0-b3f5-472e-a1e6-68d6036dcf87 54340-068 HUMAN OTC DRUG RG Sport Inv.Solid Antiperspirant Deodorant Fresh Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20110218 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 14.062 g/79g E 20171231 54340-107_cbcd58a3-60bb-4d12-9da3-83cb2e150982 54340-107 HUMAN OTC DRUG Dial Professional Antibacterial Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation ALCOHOL 72 mL/100mL E 20171231 54340-178_9780ec5c-987f-4b91-815c-d70d69ba3db8 54340-178 HUMAN OTC DRUG Dial Lavender and Twilight Jasmine Antibacterial Body Wash Triclosan SOLUTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL E 20171231 54340-179_86af53e9-6b63-4f66-9d7b-494cc7162df1 54340-179 HUMAN OTC DRUG Dial Mountain Fresh Antibacterial Body Wash Triclosan SOLUTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL E 20171231 54340-180_d8b50052-fcb5-4df6-9f7a-9224d5a15326 54340-180 HUMAN OTC DRUG Dial Tropical Escape Antibacterial Body Wash Triclosan SOLUTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL E 20171231 54340-187_a13c3891-457a-4a6b-a169-a933288aee23 54340-187 HUMAN OTC DRUG Right Guard Sport I.S. Antiperspirant Deodorant Active Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140110 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 14 g/73g N 20181231 54340-208_ed47b010-8c8c-4290-8c61-7ed8546c3337 54340-208 HUMAN OTC DRUG Right Guard Sport Active Aluminum Zirconium Trichlorohydrex GLY STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 10.318 g/73.7g E 20171231 54340-231_78cab32e-0c23-45d5-a087-991113a90244 54340-231 HUMAN OTC DRUG Right Guard Sport I.S. Antiperspirant Deodorant Triathlon Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140108 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 14 g/73g N 20181231 54340-233_e569b395-021a-40b8-84ad-3a997c820bcd 54340-233 HUMAN OTC DRUG Right Guard Sport Fresh Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20140130 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 14 g/73g N 20181231 54340-242_08b5fc7a-ac59-006c-e054-00144ff8d46c 54340-242 HUMAN OTC DRUG Benzethonium Chloride Solution Dial Spring Water Antibacterial Hand Soap SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation BENZETHONIUM CHLORIDE .1 g/100mL N 20181231 54340-243_09dfccfb-74db-7180-e054-00144ff8d46c 54340-243 HUMAN OTC DRUG Dial Antibacterial Hand Wash Dial Gold Antibacterial Hand Soap SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation, A Henkel Company BENZETHONIUM CHLORIDE .1 g/100mL N 20181231 54340-244_0a5bd1ce-bc9e-5490-e054-00144ff88e88 54340-244 HUMAN OTC DRUG Dial Antibacterial Hand Wash Dial Pomegranite and Tangerine Antibacterial Hand Soap with Moisturizer SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation, a Henkel Company BENZETHONIUM CHLORIDE .1 g/100mL N 20181231 54340-245_0a5e322f-6741-28be-e054-00144ff88e88 54340-245 HUMAN OTC DRUG Dial Antibacterial Hand Wash Dial White Tea and Vitamin E Antibacterial Hand soap with Moisturizer SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation, A Henkel Company BENZETHONIUM CHLORIDE .1 g/100mL N 20181231 54340-246_0a6c9eee-ddc0-5cf5-e054-00144ff8d46c 54340-246 HUMAN OTC DRUG Benzethonium Chloride Solution Dial Aloe Antibacterial Hand Soap with Moisturizer SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation, A Henkel Company BENZETHONIUM CHLORIDE .1 g/100mL N 20181231 54340-247_25dbcc8b-c662-634f-e054-00144ff88e88 54340-247 HUMAN OTC DRUG Dial Foaming Hand Wash Dial Complete Omega Moisture Foaming Antibacterial Hand Wash SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation, A Henkel Company BENZETHONIUM CHLORIDE .2 g/100mL N 20181231 54340-248_25dd351c-9fae-1207-e054-00144ff8d46c 54340-248 HUMAN OTC DRUG Benzethonium Chloride Solution Dial Complete Soothing White Tea Foaming Antibacterial Hand Wash SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation, A Henkel Company BENZETHONIUM CHLORIDE .2 g/100mL N 20181231 54340-249_0a70d7e2-d2a0-27cc-e054-00144ff8d46c 54340-249 HUMAN OTC DRUG Benzethonium Chloride Solution Dial Complete Spring Water Foaming Antibacterial Hand Wash SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation, A Henkel Company BENZETHONIUM CHLORIDE .2 g/100mL N 20181231 54340-250_0a71308e-fa50-33a8-e054-00144ff88e88 54340-250 HUMAN OTC DRUG Benzethonium Chloride Solution Dial Complete Fresh Pear Foaming Antibacterial Hand Wash SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation, A Henkel Company BENZETHONIUM CHLORIDE .2 g/100mL N 20181231 54340-251_0a70a80e-7ba0-6928-e054-00144ff8d46c 54340-251 HUMAN OTC DRUG Benzethonium Chloride Solution Dial Complete Power Berries Foaming Antibacterial Hand Wash SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation, A Henkel Company BENZETHONIUM CHLORIDE .2 g/100mL N 20181231 54340-252_0a726dec-a54d-5b5d-e054-00144ff8d46c 54340-252 HUMAN OTC DRUG Benzethonium Chloride Solution Dial Complete Clean Citrus Foaming Antibacterial Hand Wash SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation, A Henkel Company BENZETHONIUM CHLORIDE .2 g/100mL N 20181231 54340-253_0c12b46e-d4b5-3f87-e054-00144ff88e88 54340-253 HUMAN OTC DRUG Benzethonium Chloride Solution Dial Complete Coconut Water Foaming Antibacterial Hand Wash SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A Dial Complete Coconut Water Foaming Antibacterial Hand Wash BENZETHONIUM CHLORIDE .2 g/100mL N 20181231 54340-254_0c182e6c-dd06-09b7-e054-00144ff88e88 54340-254 HUMAN OTC DRUG Benzethonium Chloride Solution Dial Lavender and Twilight Jasmine Antibacterial Hand Soap with Moisturizer SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation, A Henkel Company BENZETHONIUM CHLORIDE .1 g/100mL N 20181231 54340-255_25dd369c-d253-3ecc-e054-00144ff88e88 54340-255 HUMAN OTC DRUG Benzethonium Chloride Solution Dial Complete Original Scent Foaming Antibacterial Hand Wash SOLUTION TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A The Dial Corporation, A Henkel Company BENZETHONIUM CHLORIDE .2 g/100mL N 20181231 54340-256_1c7061bd-dcc6-1b13-e054-00144ff88e88 54340-256 HUMAN OTC DRUG Hello Kitty Hand Sanitizer Hand Sanitizer LIQUID TOPICAL 20150803 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation, a Henkel company ALCOHOL .62 mL/mL E 20171231 54340-261_50ee70ff-f6fb-51db-e054-00144ff8d46c 54340-261 HUMAN OTC DRUG DIAL FOAMING HAND WASH Dial Complete Silk and Magnolia Foaming Antibacterial Hand Wash LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation, A Henkel Company BENZETHONIUM CHLORIDE .2 g/100mL N 20181231 54340-271_5683ecb0-8d0c-100b-e054-00144ff8d46c 54340-271 HUMAN OTC DRUG Dial Antibacterial Bar Dial Icy Aloe Antibacterial Bar Soap SOAP TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation, A Henkel Company BENZALKONIUM CHLORIDE .1 g/100g N 20181231 54340-272_55b448b7-993d-1571-e054-00144ff88e88 54340-272 HUMAN OTC DRUG Dial Antibacterial Bar Dial Gold Antibacterial Bar Soap SOAP TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation, A Henkel Company BENZALKONIUM CHLORIDE .113 g/113g N 20181231 54340-273_568372f0-ea8b-08b4-e054-00144ff8d46c 54340-273 HUMAN OTC DRUG Dial Antibacterial Bar Dial Lavander Twilight Jasmine Antibacterial Bar Soap SOAP TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation, A Henkel Company BENZALKONIUM CHLORIDE .1 g/100g N 20181231 54340-274_568518c8-e328-45a7-e054-00144ff8d46c 54340-274 HUMAN OTC DRUG Dial Antibacterial Bar Dial Mountain Fresh Antibacterial Bar Soap SOAP TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part333E The Dial Coporation, A Henkel Company BENZALKONIUM CHLORIDE .1 g/100g N 20181231 54340-275_57962ea7-9b87-8666-e053-2991aa0ae35f 54340-275 HUMAN OTC DRUG Dial Antibacterial Bar Dial for men odor armor SOAP TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation, A Henkel Company BENZALKONIUM CHLORIDE .1 g/100g N 20181231 54340-276_56915032-b132-07c5-e054-00144ff88e88 54340-276 HUMAN OTC DRUG Dial Antibacterial Bar Dial Spring Water Antibacterial Bar Soap SOAP TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation, A Henkel Company BENZALKONIUM CHLORIDE .1 g/100g N 20181231 54340-277_565564c0-ba82-54ba-e054-00144ff88e88 54340-277 HUMAN OTC DRUG Dial Antibacterial Bar Dial Tropical Escape Antibacterial Bar Soap SOAP TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation, A Henkel Company BENZALKONIUM CHLORIDE .1 g/100g N 20181231 54340-278_5691b718-bb67-1529-e054-00144ff88e88 54340-278 HUMAN OTC DRUG Dial Antibacterial Bar Dial White Antibacterial Bar Soap SOAP TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part333E The Dial Coporation, A Henkel Company BENZALKONIUM CHLORIDE .1 g/100g N 20181231 54340-279_5f8ab159-7b83-b3f2-e053-2a91aa0ae2d7 54340-279 HUMAN OTC DRUG Dial Antibacterial Bar Dial Coconut Milk Antibacterial Bar Soap SOAP TOPICAL 20170925 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation, A Henkel Company BENZALKONIUM CHLORIDE .115 g/100g N 20181231 54340-280_5f9a702a-7250-ef96-e053-2a91aa0addd7 54340-280 HUMAN OTC DRUG Dial Antibacterial Bar Dial Manuka Honey Bar Soap SOAP TOPICAL 20170925 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation, A Henkel Company BENZALKONIUM CHLORIDE .115 g/100g N 20181231 54340-281_5f99c6fc-f437-0e3a-e053-2991aa0af16b 54340-281 HUMAN OTC DRUG Dial Antibacterial Bar Dial Silk and Magnolia Antibacterial Bar Soap SOAP TOPICAL 20170925 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation, A Henkel Company BENZALKONIUM CHLORIDE .115 g/100g N 20181231 54340-282_5e9a6b89-a32b-6a00-e053-2a91aa0a1c0c 54340-282 HUMAN OTC DRUG Dial Antibacterial Bar Dial Vitamins Antibacterial Soap SOAP TOPICAL 20171002 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation, A Henkel Company BENZALKONIUM CHLORIDE .1 g/100g N 20181231 54340-400_37b69879-b0a1-42cb-a3e2-bd73f9bb97c5 54340-400 HUMAN OTC DRUG Dial Acne Control Deep Cleansing Face Wash Salicylic Acid SOLUTION TOPICAL 20140701 OTC MONOGRAPH FINAL part358H The Dial Corporation SALICYLIC ACID 20 mg/mL E 20171231 54340-410_caa27872-ec9b-42f6-9361-b5d3365c311c 54340-410 HUMAN OTC DRUG Dial Acne Control Deep Cleansing Body Wash Salicylic Acid SOLUTION TOPICAL 20140701 OTC MONOGRAPH FINAL part358H The Dial Corporation SALICYLIC ACID 20 mg/mL E 20171231 54340-482_884a5466-5b5d-4489-8403-a22a57a7417e 54340-482 HUMAN OTC DRUG Soft and Dri Clear Glide IS Antiperspirant Floral Bouquet Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20100127 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 13 g/73g E 20171231 54340-503_f0f19ff1-cbd8-4486-83b2-b1a73528462a 54340-503 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash White Tea and Vitamin E TRICLOSAN SOLUTION TOPICAL 20130325 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN 4.6 mg/mL E 20171231 54340-651_2b12cc61-da89-449b-8dae-a69f04a14e69 54340-651 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Clean Citrus, Gentle on skin TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL E 20171231 54340-652_dcad8179-b43b-42a4-b4f2-6232378ec18b 54340-652 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Cranberry with Antioxidants TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL E 20171231 54340-666_e8089487-da0a-413e-a5be-27df9290fb77 54340-666 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Iced Cranberry, Gentle on Skin TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL E 20171231 54340-681_95039f14-c642-42ba-95f7-eab168de9a63 54340-681 HUMAN OTC DRUG Dry Idea A.Dry Antiperspirant Unscented ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY LIQUID TOPICAL 20110614 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 16.3 mL/96.1mL E 20171231 54340-682_0efe1eb7-c08d-460c-9875-2413d8eb32ba 54340-682 HUMAN OTC DRUG Dry Idea AD Antiperspirant Roll-On Powder Fresh ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY LIQUID TOPICAL 20100521 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 16.3 mL/96.1mL E 20171231 54340-683_af4585e3-b572-447a-914c-e4522ab0f235 54340-683 HUMAN OTC DRUG Dry Idea A.Dry Antiperspirant Unscented ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY LIQUID TOPICAL 20110614 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 16.3 mL/96.1mL E 20171231 54340-700_5b1a3d06-cc49-46d4-974d-cefd3456bff8 54340-700 HUMAN OTC DRUG Dial Country Orchard Antibacterial Soap with Moisturizer TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL E 20171231 54340-701_f5c14c18-5a92-4284-846d-90479babd572 54340-701 HUMAN OTC DRUG Right Guard Total Defense Cool Peak Antiperspirant/Deodorant STICK TOPICAL 20070726 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 4.902 g/57g E 20171231 54340-702_165fa61e-8798-4cce-b74c-e1fd77676d10 54340-702 HUMAN OTC DRUG Right Guard Total Defense Fresh Blast Antiperspirant/Deodorant STICK TOPICAL 20070726 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 4.902 g/57g E 20171231 54340-751_4664b3e8-69ca-4cbd-8a0e-84f95c2a3b57 54340-751 HUMAN OTC DRUG RG TD5 Inv.Solid Antiperspirant Deodorant Fresh Blast Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20111027 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 2.0944 g/11.9g E 20171231 54340-764_6fba08e0-8873-43b1-8598-2b02b1fbc06a 54340-764 HUMAN OTC DRUG Berkley Jensen Hypoallergenic Antibacterial Hand Soap Soap Enriched with Vitamin E and Aloe Vera Moisturizers TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL E 20171231 54340-771_a122dfac-39d7-428d-a2da-046a9a1f5ae5 54340-771 HUMAN OTC DRUG Dry Idea A.Dry Inv.Sol. Antiperspirant Cool Blast Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20111109 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 15.4 g/73g E 20171231 54340-777_993776f4-cd4e-4472-be7d-6eb5d858aedc 54340-777 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Gentle on Skin, Frosted Pear with Lotion TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL E 20171231 54340-778_dce76cf2-4131-47c8-ade1-46decd7a7811 54340-778 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Original Scent, Gentle on skin TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL E 20171231 54340-779_1941255a-d754-41d4-9d73-74c8befcea69 54340-779 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Cool Plum, Gentle on skin TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL E 20171231 54340-783_ffe74a52-154b-4528-af45-ce8aa27ab62a 54340-783 HUMAN OTC DRUG Dial Clear and Refresh Antibacterial Hand Soap Clear TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL E 20171231 54340-797_e695f870-7c83-46af-94a9-3eee2ffce98d 54340-797 HUMAN OTC DRUG Dial Aloe Antibacterial Soap with Moisturizer TRICLOSAN SOLUTION TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL E 20171231 54340-798_7e51aab9-518f-4944-a1a5-7ea0f2e59fb5 54340-798 HUMAN OTC DRUG Dial Pomeganate and Tangerine Antibacterial Soap with Moisturizer TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL E 20171231 54340-799_d2ab64c6-776c-4019-b07d-49da210b8742 54340-799 HUMAN OTC DRUG Dial Spring Water Antibacterial Soap with Moisturizer TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL E 20171231 54340-800_e5d2d2c7-f2ec-43f4-9afd-808b93e732ff 54340-800 HUMAN OTC DRUG Dial Gold Antibacterial Soap with Moisturizer TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL E 20171231 54340-801_1c76ea3a-0c6b-4963-a415-8366121484f0 54340-801 HUMAN OTC DRUG Dial Mountain Fresh Antibacterial Soap with Moisturizers TRICLOSAN SOLUTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL E 20171231 54340-802_38933b72-8c01-4212-a489-455bf28ef783 54340-802 HUMAN OTC DRUG Dial White Tea and Vitamin E Antibacterial Hand Soap Triclosan SOLUTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .15 mL/1000mL E 20171231 54340-809_5206165a-25dc-469c-a22e-fe76d2330463 54340-809 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Soothing White Tea, Gentle on skin TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL E 20171231 54340-810_19fe0844-6e5b-4828-a064-73a0378e01c9 54340-810 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash Hello Kitty TRICLOSAN SOLUTION TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 g/100mL E 20171231 54340-813_77f9abb5-5d4a-4886-8989-b8347281f7d2 54340-813 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Washkitchen crisp limkitchen crisp lim kitchen crisp lime TRICLOSAN SOLUTION TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mg/1000mL E 20171231 54340-814_33d15242-ee9b-4788-8344-5ea070cd0b4a 54340-814 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Washholiday line holiday line holiday line TRICLOSAN SOLUTION TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN 4.6 mg/mL E 20171231 54340-833_e1ce3ce2-e3a9-415b-be5d-73422605af17 54340-833 HUMAN OTC DRUG RG Sport Inv.Solid Antiperspirant Deodorant Cool Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20110323 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 14.062 g/79g E 20171231 54340-842_c77afc69-89e9-4888-b53b-e21aae754ed5 54340-842 HUMAN OTC DRUG Soft and Dri Clear Glide IS Antiperspirant Powder Soft Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20110614 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 13 g/73g E 20171231 54340-866_e90ce213-916a-4934-a281-2966e3180401 54340-866 HUMAN OTC DRUG Dry Idea A.Dry Antiperspirant Solid Powder Fresh Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20110211 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 15.4 g/73g E 20171231 54340-969_f5e4b981-63b3-4b82-862d-ca8edf9458df 54340-969 HUMAN OTC DRUG Dry Idea A.Dry Antiperspirant Solid Unscented Aluminum Zirconium Pentachlorohydrex Gly STICK TOPICAL 20110211 OTC MONOGRAPH FINAL part350 The Dial Corporation ALUMINUM ZIRCONIUM PENTACHLOROHYDREX GLY 14.6 g/73g E 20171231 54340-986_dce95b78-dbfb-43f6-80a8-ab07d88fa0db 54340-986 HUMAN OTC DRUG Dial Complete Antibacterial Foaming Hand Wash with Lotion Fresh Pear with Lotion TRICLOSAN SOLUTION TOPICAL 20090619 OTC MONOGRAPH NOT FINAL part333E The Dial Corporation TRICLOSAN .46 mL/1000mL E 20171231 54348-013_47c0f6e2-91e1-42d2-9fce-c74799ac3109 54348-013 HUMAN PRESCRIPTION DRUG HYDROCODONE/APAP HYDROCODONE BITARTRATE, TABLET ORAL 20140901 ANDA ANDA040099 PharmPak, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 54348-015_ab7b039f-49a0-4c2b-b1ad-b14e89448cc8 54348-015 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN with CODEINE ACETAMINOPHEN, CODEINE PHOSPHATE TABLET ORAL 20131231 ANDA ANDA089805 PharmPak, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 54348-066_d0bab4bf-d2a1-4a7a-9141-3b9a7ffc9975 54348-066 HUMAN PRESCRIPTION DRUG HYDROCODONE/APAP HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20140901 ANDA ANDA040736 PharmPak, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 54365-170_eb3a003b-577f-4bb2-a45a-ac71f6b970d7 54365-170 HUMAN OTC DRUG Isopropyl Alcohol Sepp isopropyl alcohol SOLUTION TOPICAL 19880201 OTC MONOGRAPH NOT FINAL part333A CareFusion 213 LLC ISOPROPYL ALCOHOL .7 mL/mL N 20181231 54365-400_59a09565-6b4d-6d15-e053-2991aa0a9724 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20050510 NDA NDA021555 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54365-400_59c9ae6e-e5c7-750c-e053-2991aa0a6b63 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20050510 NDA NDA021555 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54365-400_5a2b5034-8896-b295-e053-2a91aa0a71c1 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20020426 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54365-400_5a2baa54-6641-3bd0-e053-2a91aa0a5f89 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20021007 NDA NDA021555 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54365-400_5a2caf7d-d5ca-493d-e053-2991aa0ae208 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20140723 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54365-400_5a2d5052-95bd-d103-e053-2991aa0aa4be 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20000714 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54365-400_5a2e9a41-0a97-3baf-e053-2a91aa0a082e 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20060818 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54365-400_5a30926d-d689-d49f-e053-2a91aa0a3574 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20000714 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54365-400_5a30d148-c893-5ece-e053-2a91aa0a623a 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20060818 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54365-400_5a31a0b1-9125-bbaa-e053-2991aa0ad928 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20000714 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54365-400_5a31b284-95a3-0406-e053-2a91aa0ac2e4 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20020426 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54365-400_5a33c00e-22e4-28ce-e053-2a91aa0a5940 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20020426 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54365-400_5c376406-c2a3-780f-e053-2a91aa0a8b4f 54365-400 HUMAN OTC DRUG ChloraPrep One-Step chlorhexidine gluconate and isopropyl alcohol SOLUTION TOPICAL 20060818 NDA NDA020832 CareFusion 213 LLC CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 54371-471_f22e9a97-1c45-472a-aee3-17c0a4223cbb 54371-471 HUMAN OTC DRUG OraBrite SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111031 OTC MONOGRAPH NOT FINAL part356 Oraline, Inc. SODIUM FLUORIDE .22 g/100g E 20171231 54384-1072_75313f91-3cdb-4e6b-9e65-fd8f8eaf9338 54384-1072 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19720101 UNAPPROVED MEDICAL GAS American Oxygen Company, Inc OXYGEN 99 L/100L E 20171231 54396-801_8ec18670-b429-432f-b7c5-7a43fd397c47 54396-801 HUMAN PRESCRIPTION DRUG Krystexxa pegloticase INJECTION, SOLUTION INTRAVENOUS 20100914 BLA BLA125293 Savient Pharmaceuticals, Inc. PEGLOTICASE 8 mg/mL Urate Oxidase [Chemical/Ingredient],Uric Acid-specific Enzyme [EPC] E 20171231 54410-001_dd133d21-b8a2-40e5-b31d-fd8f272adbdf 54410-001 HUMAN OTC DRUG 4 SURE Plus E3 Instant Foam Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part333A DevMar Products LLC BENZALKONIUM CHLORIDE 1 mg/mL E 20171231 54416-001_67a671f3-f902-46a8-a740-8fad89c21920 54416-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19931117 UNAPPROVED MEDICAL GAS Nordan Smith Welding Supply OXYGEN 995 mL/L E 20171231 54416-002_4d508bb2-43f2-4b7e-9a2e-df14849d8fe1 54416-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS ENDOSINUSIAL 19931118 UNAPPROVED MEDICAL GAS Nordan Smith Welding Supply NITROGEN 995 mL/L E 20171231 54416-003_9fef6575-7bd5-47ca-aca5-ec57eb6d173a 54416-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19940112 UNAPPROVED MEDICAL GAS Nordan Smith Welding Supply CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 54416-004_433f76dd-f6af-44a8-9907-85b57b11953a 54416-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19931118 UNAPPROVED MEDICAL GAS Nordan Smith Welding Supply AIR 215 mL/L E 20171231 54416-005_b4dc71a9-6a28-445a-92d8-a8edef36b95a 54416-005 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19940225 UNAPPROVED MEDICAL GAS Nordan Smith Welding Supply HELIUM 995 mL/L E 20171231 54416-006_af88eceb-b8a7-4106-b732-13ccc5f46cf1 54416-006 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19950104 UNAPPROVED MEDICAL GAS Nordan Smith Welding Supply NITROUS OXIDE 990 mL/L E 20171231 54427-001_5c12489e-f8df-4704-9d67-72b4277d1efe 54427-001 HUMAN OTC DRUG BIOARPIL SALICYLIC ACID OINTMENT TOPICAL 20120701 OTC MONOGRAPH FINAL part358H BIOARPIL USA, INC. SALICYLIC ACID 2.8 g/140g E 20171231 54429-0101_8306b85d-a2e0-4740-8f1b-703742e58912 54429-0101 HUMAN OTC DRUG Alcohol Prep Pad isopropyl alcohol SWAB TOPICAL 20121226 OTC MONOGRAPH NOT FINAL part333A Foshan Flying Medical Products Co., Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 54429-0102_71937731-2b5b-4517-8d73-f917fab5dbc8 54429-0102 HUMAN OTC DRUG PHARMACIST CHOICE ALCOHOL PREP PAD isopropyl alcohol SWAB TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part333A Foshan Flying Medical Products Co., Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 54429-0103_cde68333-22ac-4154-b2ae-581963d8da4b 54429-0103 HUMAN OTC DRUG BZK antiseptic swab benzalkonium chloride SWAB TOPICAL 20121227 OTC MONOGRAPH NOT FINAL part333A Foshan Flying Medical Products Co., Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 54429-0104_eac50804-f093-4a9a-b57a-e4ce59e418a2 54429-0104 HUMAN OTC DRUG Povidone-iodine prep pad povidone-iodine SWAB TOPICAL 20130115 OTC MONOGRAPH FINAL part333C Foshan Flying Medical Products Co., Ltd. POVIDONE-IODINE 9.43 g/100g N 20181231 54429-0106_a363b572-fd50-4f2f-bc69-f9232c2deb12 54429-0106 HUMAN OTC DRUG Antiseptic Cleansing Wipes chlorhexidine gluconate SWAB TOPICAL 20121227 UNAPPROVED DRUG OTHER Foshan Flying Medical Products Co., Ltd. CHLORHEXIDINE GLUCONATE .0002 mg/mg N 20181231 54429-0107_badc4429-4a0f-48e9-b7cf-230f312faa2e 54429-0107 HUMAN OTC DRUG EYE WASH EYE WASH LIQUID OPHTHALMIC 20160914 OTC MONOGRAPH FINAL part349 Foshan Flying Medical Products Co., Ltd. WATER 99.1 mL/100mL N 20181231 54436-010_95ad6aad-09df-45ed-a1d7-fc58e35a8102 54436-010 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 10 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 54436-012_95ad6aad-09df-45ed-a1d7-fc58e35a8102 54436-012 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 12.5 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 54436-015_95ad6aad-09df-45ed-a1d7-fc58e35a8102 54436-015 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 15 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 54436-017_95ad6aad-09df-45ed-a1d7-fc58e35a8102 54436-017 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 17.5 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 54436-020_95ad6aad-09df-45ed-a1d7-fc58e35a8102 54436-020 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 20 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 54436-022_95ad6aad-09df-45ed-a1d7-fc58e35a8102 54436-022 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 22.5 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 54436-025_95ad6aad-09df-45ed-a1d7-fc58e35a8102 54436-025 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 25 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 54451-001_3ea336fb-a349-4e47-9161-a8278cc0f2a7 54451-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000101 NDA NDA205767 Baker's Gas & Welding Supplies Inc. OXYGEN 999 mL/L N 20181231 54451-005_307315a6-7c7f-45b0-a929-a07240037032 54451-005 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20000101 NDA NDA205766 Baker's Gas & Welding Supplies Inc. NITROGEN 990 mL/L N 20181231 54458-844_6b56d429-0c0e-4db5-a1d1-cec79de2b08a 54458-844 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20170607 ANDA ANDA075551 International Laboratories, LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-845_6b56d429-0c0e-4db5-a1d1-cec79de2b08a 54458-845 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20170407 ANDA ANDA075551 International Laboratories, LLC LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-846_6b56d429-0c0e-4db5-a1d1-cec79de2b08a 54458-846 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20170606 ANDA ANDA075551 International Laboratories, LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-847_d8e5b592-3bcb-4856-bc05-9edefc87d5d9 54458-847 HUMAN OTC DRUG NASAL DECONGESTANT PE phenylephrine hydrochloride TABLET ORAL 20160527 OTC MONOGRAPH FINAL part341 International Laboratories, LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 54458-848_626eef2c-084a-4769-9fb2-6f3e2efbb790 54458-848 HUMAN OTC DRUG ALLERGY RELIEF loratadine TABLET ORAL 20160527 ANDA ANDA076301 International Laboratories, LLC LORATADINE 10 mg/1 N 20181231 54458-849_57331cce-8349-4503-9386-dd52b561a206 54458-849 HUMAN OTC DRUG loperamide hydrochloride loperamide hcl TABLET, FILM COATED ORAL 20160601 ANDA ANDA075232 International Laboratories, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 54458-850_68290b15-6aee-49bc-b5a2-b8214969be17 54458-850 HUMAN OTC DRUG IBUPROFEN ibuprofen TABLET ORAL 20160601 ANDA ANDA072096 International Laboratories, LLC IBUPROFEN 200 mg/1 N 20181231 54458-851_b5efaa47-3226-47f5-9e95-abd40e79240a 54458-851 HUMAN OTC DRUG ACID CONTROLLER Famotidine TABLET ORAL 20160527 ANDA ANDA077351 International Laboratories, LLC FAMOTIDINE 20 mg/1 N 20181231 54458-857_98918478-cde4-48e8-8ad3-e3113454849e 54458-857 HUMAN OTC DRUG SLEEP-AID Diphenhydramine hydrochloride TABLET ORAL 20160527 OTC MONOGRAPH FINAL part338 International Laboratories, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 54458-858_dc9f3b7e-d174-4468-9712-ae0fda1ac37c 54458-858 HUMAN OTC DRUG Allergy Relief diphenhydramine hydrochloride TABLET ORAL 20160527 OTC MONOGRAPH FINAL part341 International Laboratories, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 54458-859_522478e3-f6a5-4f29-97ac-4426480f4d22 54458-859 HUMAN OTC DRUG Allergy Relief cetirizine hydrochloride TABLET, FILM COATED ORAL 20160527 ANDA ANDA078336 International Laboratories, LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 54458-860_f649a91f-36cc-4e21-b546-3eb116f27921 54458-860 HUMAN OTC DRUG ARTHRITIS PAIN RELIEF acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160601 ANDA ANDA075077 International Laboratories, LLC ACETAMINOPHEN 650 mg/1 N 20181231 54458-861_8223c051-2f65-4d2d-a681-f6138fa4b275 54458-861 HUMAN OTC DRUG Pain Relief Extra Strength acetaminophen TABLET ORAL 20160527 OTC MONOGRAPH NOT FINAL part343 International Laboratories, LLC ACETAMINOPHEN 500 mg/1 N 20181231 54458-862_3aa69b8e-c8b7-45ed-be0f-8be559dec3ce 54458-862 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140201 ANDA ANDA076118 International Laboratories, LLC BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 54458-863_3aa69b8e-c8b7-45ed-be0f-8be559dec3ce 54458-863 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140201 ANDA ANDA076118 International Laboratories, LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 54458-864_a4eef739-cd4c-4e92-98f3-039301cf640b 54458-864 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20150501 ANDA ANDA077210 International Laboratories, LLC PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 54458-865_a4eef739-cd4c-4e92-98f3-039301cf640b 54458-865 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20150501 ANDA ANDA077210 International Laboratories, LLC PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 54458-866_a4eef739-cd4c-4e92-98f3-039301cf640b 54458-866 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20150501 ANDA ANDA077210 International Laboratories, LLC PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 54458-867_7c33976e-6c45-4647-999e-f3a7a76f9d8c 54458-867 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20150501 ANDA ANDA076056 International Laboratories, LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-869_7c33976e-6c45-4647-999e-f3a7a76f9d8c 54458-869 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20150501 ANDA ANDA076056 International Laboratories, LLC PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-870_5dbf2a60-cba9-4c2e-bb44-c19a3e7cda96 54458-870 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20150520 ANDA ANDA075551 International Laboratories, LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-871_5dbf2a60-cba9-4c2e-bb44-c19a3e7cda96 54458-871 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20150520 ANDA ANDA075551 International Laboratories, LLC LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-872_afd62147-bee8-4c0e-95b6-1bd5c15adfa8 54458-872 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20150512 ANDA ANDA077321 International Laboratories, LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 54458-873_afd62147-bee8-4c0e-95b6-1bd5c15adfa8 54458-873 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20150512 ANDA ANDA077321 International Laboratories, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 54458-874_afd62147-bee8-4c0e-95b6-1bd5c15adfa8 54458-874 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20150512 ANDA ANDA077321 International Laboratories, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 54458-877_afd62147-bee8-4c0e-95b6-1bd5c15adfa8 54458-877 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20150512 ANDA ANDA077321 International Laboratories, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 54458-878_ec34b2e2-8f16-4750-a0a3-32d26809ca3f 54458-878 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20150501 ANDA ANDA085182 International Laboratories, LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 54458-879_ec34b2e2-8f16-4750-a0a3-32d26809ca3f 54458-879 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20150316 ANDA ANDA085182 International Laboratories, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 54458-881_71753441-8d32-4947-b69b-d51e4197077f 54458-881 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20140601 ANDA ANDA090548 International Laboratories, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-884_05ae0b63-253a-4685-8952-3122b0818661 54458-884 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20131208 NDA AUTHORIZED GENERIC NDA021073 International Laboratories, LLC PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 54458-885_05ae0b63-253a-4685-8952-3122b0818661 54458-885 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20131208 NDA AUTHORIZED GENERIC NDA021073 International Laboratories, LLC PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 54458-886_d6d92c32-8f91-4d6a-a8ed-f7749fe3b57a 54458-886 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20140304 ANDA ANDA077912 International Laboratories, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 54458-888_af40b30d-a0bb-4d9f-a779-1cd93a8c4ab3 54458-888 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20131202 ANDA ANDA076999 International Laboratories, LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 54458-889_b11fbcbe-c258-4bb2-9592-d724399dc153 54458-889 HUMAN PRESCRIPTION DRUG CITALOPRAM CITALOPRAM TABLET, FILM COATED ORAL 20140101 ANDA ANDA077038 International Laboratories, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54458-890_027c648e-3e87-4458-9973-d305db3aefed 54458-890 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, FILM COATED ORAL 20131004 ANDA ANDA078605 International Laboratories, LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 54458-891_93eb425e-f858-4f2b-89eb-6f49b956cef2 54458-891 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130920 ANDA ANDA076765 International Laboratories, LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54458-892_93eb425e-f858-4f2b-89eb-6f49b956cef2 54458-892 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130919 ANDA ANDA076765 International Laboratories, LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54458-893_2a74bad2-b2d1-4651-a2dd-f52da16d1f90 54458-893 HUMAN PRESCRIPTION DRUG Benazepril Benazepril TABLET, COATED ORAL 20130919 ANDA ANDA076211 International Laboratories, LLC BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 54458-894_8d73e0c4-878c-481d-bcdb-25797d00aec9 54458-894 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130919 ANDA ANDA077837 International Laboratories, LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-899_8d73e0c4-878c-481d-bcdb-25797d00aec9 54458-899 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130901 ANDA ANDA077837 International Laboratories, LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-914_7e62b171-b224-4ffd-a785-f57ee81abeac 54458-914 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20080327 ANDA ANDA075551 International Laboratories, LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-915_7e62b171-b224-4ffd-a785-f57ee81abeac 54458-915 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20080327 ANDA ANDA075551 International Laboratories, LLC LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-916_7e62b171-b224-4ffd-a785-f57ee81abeac 54458-916 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20080327 ANDA ANDA075551 International Laboratories, LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-920_967f597e-8cb2-430c-a10c-3811c2385df5 54458-920 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20101015 ANDA ANDA077921 International Laboratories, LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 54458-921_c6cf9469-f285-44f6-95c2-8e71d2199ae0 54458-921 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20101015 ANDA ANDA077912 International Laboratories, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 54458-925_c40db372-1d5d-4c4d-ac37-ea32e709e9be 54458-925 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20080327 ANDA ANDA076056 International Laboratories, LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-926_c40db372-1d5d-4c4d-ac37-ea32e709e9be 54458-926 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20090209 ANDA ANDA076056 International Laboratories, LLC PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-927_6316f531-a9e0-49a9-8a6a-fa29675217cb 54458-927 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20130426 ANDA ANDA076056 International Laboratories, LLC PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-929_11b71e38-a0b4-4718-b061-f8568f837f29 54458-929 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110801 ANDA ANDA040807 International Laboratories, LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 54458-930_11b71e38-a0b4-4718-b061-f8568f837f29 54458-930 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20110801 ANDA ANDA040807 International Laboratories, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 54458-932_76007de6-8f5b-4dac-94b3-df682d38bb65 54458-932 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20101122 ANDA ANDA076052 International Laboratories, LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-933_76007de6-8f5b-4dac-94b3-df682d38bb65 54458-933 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20101127 ANDA ANDA076052 International Laboratories, LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-934_76007de6-8f5b-4dac-94b3-df682d38bb65 54458-934 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20101128 ANDA ANDA076052 International Laboratories, LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-936_48d03a7b-c39b-4d91-a216-d01600dccc18 54458-936 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20100410 ANDA ANDA078296 International Laboratories, LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-937_48d03a7b-c39b-4d91-a216-d01600dccc18 54458-937 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20100403 ANDA ANDA078296 International Laboratories, LLC LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-938_48d03a7b-c39b-4d91-a216-d01600dccc18 54458-938 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20100322 ANDA ANDA078296 International Laboratories, LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 54458-944_1df1e53e-bbdd-4bec-a1d5-5b0885a7357b 54458-944 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20090512 ANDA ANDA077397 International Laboratories, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54458-945_1df1e53e-bbdd-4bec-a1d5-5b0885a7357b 54458-945 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20090510 ANDA ANDA077397 International Laboratories, LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54458-947_1df1e53e-bbdd-4bec-a1d5-5b0885a7357b 54458-947 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20090507 ANDA ANDA077397 International Laboratories, LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54458-948_1211a605-ca29-47c7-9ba9-4170fd533722 54458-948 HUMAN PRESCRIPTION DRUG NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE ORAL 20090822 ANDA ANDA077127 International Laboratories, LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 54458-950_1211a605-ca29-47c7-9ba9-4170fd533722 54458-950 HUMAN PRESCRIPTION DRUG NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE ORAL 20090821 ANDA ANDA077127 International Laboratories, LLC NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 54458-957_9408d177-1b59-4d54-b418-e8b0f25502cb 54458-957 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20090301 ANDA ANDA076402 International Laboratories, LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 54458-964_59b89ff0-3599-4356-8324-dbef6eb77d47 54458-964 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20081201 ANDA ANDA077921 International Laboratories, LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 54458-965_59b89ff0-3599-4356-8324-dbef6eb77d47 54458-965 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20081201 ANDA ANDA077921 International Laboratories, LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 54458-966_61a81a44-8e6d-486b-954c-484b79afe0af 54458-966 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20090206 ANDA ANDA077091 International Laboratories, LLC GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 54458-967_61a81a44-8e6d-486b-954c-484b79afe0af 54458-967 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20090206 ANDA ANDA077091 International Laboratories, LLC GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 54458-968_61a81a44-8e6d-486b-954c-484b79afe0af 54458-968 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20090206 ANDA ANDA077091 International Laboratories, LLC GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 54458-980_b11fbcbe-c258-4bb2-9592-d724399dc153 54458-980 HUMAN PRESCRIPTION DRUG CITALOPRAM CITALOPRAM TABLET, FILM COATED ORAL 20080625 ANDA ANDA077038 International Laboratories, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54458-981_b11fbcbe-c258-4bb2-9592-d724399dc153 54458-981 HUMAN PRESCRIPTION DRUG CITALOPRAM CITALOPRAM TABLET, FILM COATED ORAL 20080625 ANDA ANDA077038 International Laboratories, LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54458-988_c1ac6b07-7bcf-4949-823e-1e9fa115c6c9 54458-988 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET ORAL 20071211 ANDA ANDA077584 International Laboratories, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54458-989_c1ac6b07-7bcf-4949-823e-1e9fa115c6c9 54458-989 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET ORAL 20071211 ANDA ANDA077584 International Laboratories, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54458-990_c1ac6b07-7bcf-4949-823e-1e9fa115c6c9 54458-990 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET ORAL 20071211 ANDA ANDA077584 International Laboratories, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54458-991_1d227f42-d1f4-4b7c-8741-a3c3def38eb2 54458-991 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20071215 ANDA ANDA077912 International Laboratories, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 54458-992_1d227f42-d1f4-4b7c-8741-a3c3def38eb2 54458-992 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20071215 ANDA ANDA077912 International Laboratories, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 54458-993_1d227f42-d1f4-4b7c-8741-a3c3def38eb2 54458-993 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20071215 ANDA ANDA077912 International Laboratories, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 54458-994_bc7455da-6a54-4d33-b7aa-de7b8dbf2a16 54458-994 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 International Laboratories, LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 54458-995_bc7455da-6a54-4d33-b7aa-de7b8dbf2a16 54458-995 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 International Laboratories, LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 54458-996_bc7455da-6a54-4d33-b7aa-de7b8dbf2a16 54458-996 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 International Laboratories, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 54458-997_bc7455da-6a54-4d33-b7aa-de7b8dbf2a16 54458-997 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 International Laboratories, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 54458-998_bc7455da-6a54-4d33-b7aa-de7b8dbf2a16 54458-998 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 International Laboratories, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 54458-999_bc7455da-6a54-4d33-b7aa-de7b8dbf2a16 54458-999 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20080201 ANDA ANDA077321 International Laboratories, LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 54473-080_5e625e37-7a05-469e-88f4-b66404c78d26 54473-080 HUMAN OTC DRUG CounterAct Cough Dextromethorphan HBr. and Guaifenesin SYRUP ORAL 20090828 OTC MONOGRAPH FINAL part341 Melaleuca, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 54473-098_0366e2e1-80fe-4980-839f-277ef17d9639 54473-098 HUMAN OTC DRUG CounterAct Childrens Pain Reliever Acetaminophen SUSPENSION ORAL 20100112 OTC MONOGRAPH NOT FINAL part343 Melaleuca, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 54473-117_d36aedc4-fb4f-43f0-bf9c-89593671db06 54473-117 HUMAN OTC DRUG DermaCort Anti-Itch Hydrocortisone CREAM TOPICAL 20000802 OTC MONOGRAPH NOT FINAL part348 Melaleuca, Inc. HYDROCORTISONE 10 mg/g E 20171231 54473-131_d6a4ea83-9b39-44a2-961b-9685f01209c1 54473-131 HUMAN OTC DRUG CounterAct Cough Drops Orchard Cherry Menthol LOZENGE ORAL 20080520 OTC MONOGRAPH FINAL part341 Melaleuca, Inc. MENTHOL 7 mg/1 E 20171231 54473-132_41e9caf1-71a5-461a-b523-4159edf8b7b1 54473-132 HUMAN OTC DRUG CounterAct Cough Drops Honey Lemon Menthol LOZENGE ORAL 20080520 OTC MONOGRAPH FINAL part341 Melaleuca, Inc. MENTHOL 7 mg/1 E 20171231 54473-134_8fe03304-24d2-48d5-8f51-c4db514f704d 54473-134 HUMAN OTC DRUG CounterAct IB Ibuprofen TABLET, FILM COATED ORAL 20100318 OTC MONOGRAPH NOT FINAL part343 Melaleuca, Inc. IBUPROFEN 200 mg/1 N 20181231 54473-137_3c300ef2-2c23-486d-b99b-1cb11b945153 54473-137 HUMAN OTC DRUG SunShades 15 Lip Balm Harvest Berry Octinoxate and Oxybenzone STICK TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g E 20171231 54473-141_a6c8846f-00a3-45d1-aee0-664fc4839de7 54473-141 HUMAN OTC DRUG Clear Defense Ethyl alcohol GEL TOPICAL 20100409 OTC MONOGRAPH NOT FINAL part333A Melaleuca, Inc. ALCOHOL 39.184 g/70mL E 20171231 54473-142_570311be-cb6a-4a19-a2cb-8e85906b7499 54473-142 HUMAN OTC DRUG Clear Defense Hand Sanitizing Wipes alcohol CLOTH TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part333A Melaleuca, Inc. ALCOHOL 3.32 g/1 N 20181231 54473-150_29f8abd2-dd0d-4959-ba71-95ab4b7ee342 54473-150 HUMAN OTC DRUG Pain-A-Trate Extra Strength Pain-Relieving Camphor and Menthol and Methyl Salicylate CREAM TOPICAL 20070501 OTC MONOGRAPH NOT FINAL part348 Melaleuca, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 32.5; 15; 150 mg/g; mg/g; mg/g E 20171231 54473-151_323337af-3d79-0658-e054-00144ff8d46c 54473-151 HUMAN OTC DRUG Alloy Antiperspirant and Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20070501 OTC MONOGRAPH FINAL part350 Melaleuca, Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.39 g/64g E 20171231 54473-152_e22b94e5-ef0a-418f-aa77-6b1df5059cca 54473-152 HUMAN OTC DRUG Body Satin Antiperspirant and Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20070801 OTC MONOGRAPH FINAL part350 Melaleuca, Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 10.146 g/57g E 20171231 54473-160_5f858d5d-ec8d-45d3-adce-234534d89435 54473-160 HUMAN OTC DRUG SUN SHADES 15 Lip Balm Cranberry Tangerine octinoxate and oxybenzone STICK TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g E 20171231 54473-161_46822024-02e4-4193-af02-12af74ea320e 54473-161 HUMAN OTC DRUG SUN SHADES 15 Lip Balm Cherry Candy Cane octinoxate and oxybenzone STICK TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g E 20171231 54473-162_0887440f-3c85-49c0-a2b4-acd9840fd322 54473-162 HUMAN OTC DRUG SUN SHADES 15 Lip Balm Lemon Gum Drop octinoxate and oxybenzone STICK TOPICAL 20071001 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g E 20171231 54473-164_14c560f4-08f8-4f3a-9eed-3014820bfd78 54473-164 HUMAN OTC DRUG Sun Shades Mineral Plus Sunscreen Octisalate and Zinc Oxide CREAM TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTISALATE; ZINC OXIDE 9.225; 18.45 g/177mL; g/177mL E 20171231 54473-166_2a4002de-5be9-42b1-aef9-2d4223e95f04 54473-166 HUMAN OTC DRUG CounterAct Allergy Loratadine TABLET ORAL 20080628 ANDA ANDA075209 Melaleuca, Inc. LORATADINE 10 mg/1 N 20181231 54473-168_967dad22-e802-4c24-86ea-a24a0297a4a7 54473-168 HUMAN OTC DRUG Sun Shades Lip Balm Pomegranate SPF 15 Octinoxate and Oxybenzone STICK TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g E 20171231 54473-174_22e7a4e4-595f-49e7-8380-ee3cce81200e 54473-174 HUMAN OTC DRUG SPF 15 Fair TITANIUM DIOXIDE POWDER TOPICAL 20100915 OTC MONOGRAPH FINAL part352 Melaleuca, Inc. TITANIUM DIOXIDE .7 g/10g N 20181231 54473-175_5bf641c7-b807-4b6a-a1e4-df2efc961a95 54473-175 HUMAN OTC DRUG SPF 15 Light TITANIUM DIOXIDE POWDER TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. TITANIUM DIOXIDE .7 g/10g N 20181231 54473-176_b3c10e1a-4d87-45e1-8e8e-90fed0f8657e 54473-176 HUMAN OTC DRUG SPF 15 Medium TITANIUM DIOXIDE POWDER TOPICAL 20100915 OTC MONOGRAPH FINAL part352 Melaleuca, Inc. TITANIUM DIOXIDE .7 g/10g N 20181231 54473-177_0bccf51f-0856-43d0-a3d9-a04c6cb9a673 54473-177 HUMAN OTC DRUG SPF 15 Warm Tan TITANIUM DIOXIDE POWDER TOPICAL 20100915 OTC MONOGRAPH FINAL part352 Melaleuca, Inc. TITANIUM DIOXIDE .7 g/10g N 20181231 54473-179_ef097c87-7eae-401b-b961-81aa8b4da288 54473-179 HUMAN OTC DRUG SPF 15 Deep TITANIUM DIOXIDE POWDER TOPICAL 20100915 OTC MONOGRAPH FINAL part352 Melaleuca, Inc. TITANIUM DIOXIDE .7 g/10g N 20181231 54473-180_7db048a3-6556-41d8-a5fe-b75e462d266e 54473-180 HUMAN OTC DRUG HemAway Lidocane and Phenylephrine HCL CREAM TOPICAL 20101213 OTC MONOGRAPH FINAL part346 Melaleuca, Inc. LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE 50; 2.5 mg/g; mg/g N 20181231 54473-181_5e0f885e-48fb-3921-e053-2991aa0a2153 54473-181 HUMAN OTC DRUG CounterAct Pain Acetaminophen TABLET, FILM COATED ORAL 20110301 OTC MONOGRAPH NOT FINAL part343 Melaleuca, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 54473-182_5e0e2f9e-17ea-34a5-e053-2a91aa0a56c7 54473-182 HUMAN OTC DRUG CounterAct PM Acetaminophen and Diphenhydramine TABLET ORAL 20110401 OTC MONOGRAPH NOT FINAL part343 Melaleuca, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 54473-183_b559b01b-24ee-46c4-a1ff-2a63ab89f447 54473-183 HUMAN OTC DRUG CounterAct IB Ibuprofen TABLET, COATED ORAL 20110430 OTC MONOGRAPH FINAL part343 Melaleuca, Inc IBUPROFEN 200 mg/1 E 20171231 54473-184_7b1c2e71-7c20-4f48-be83-6f3b59f45bf9 54473-184 HUMAN OTC DRUG CounterAct Night Acetaminophen, Diphenydramine HCI, Phenylephrine HCI TABLET, COATED ORAL 20110801 OTC MONOGRAPH FINAL part341 Melaleuca, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 E 20171231 54473-185_4c3e5de6-2bd5-408f-94aa-d93af6cbdc74 54473-185 HUMAN OTC DRUG CounterAct Day Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine TABLET, FILM COATED ORAL 20111001 OTC MONOGRAPH FINAL part341 Melaleuca, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 54473-186_58c8da02-a1d6-492e-9bc1-c5c26fac5ec5 54473-186 HUMAN OTC DRUG Sei Bella Daytime Delivery Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .9; 3; 1.5; .93; .9 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL E 20171231 54473-187_deeaf705-bf52-46a4-81a8-4d36cbbdb046 54473-187 HUMAN OTC DRUG Sei Bella Daytime Delivery avobenzone, homosalate, octisalate, ocrylene and oxybenzone LOTION TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .9018; 3.006; 1.503; .9319; .9018 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL E 20171231 54473-188_9409ac74-864b-4c54-9a92-14adf0f70423 54473-188 HUMAN OTC DRUG Whitening Tooth Polish Sodium Fluoride PASTE TOPICAL 20100401 OTC MONOGRAPH FINAL part355 Melaleuca, Inc. SODIUM FLUORIDE .26244 g/108g N 20181231 54473-203_b35ee7ff-3053-4588-a68d-becc276e0098 54473-203 HUMAN OTC DRUG Calmicid AC Acid Reducer Loratadine TABLET, FILM COATED ORAL 20110120 ANDA ANDA090283 Melaleuca, Inc. FAMOTIDINE 20 mg/1 N 20181231 54473-204_888a65ac-6a06-4065-abf3-0491e586aaf6 54473-204 HUMAN OTC DRUG koala pals berrylicious Sodium Fluoride PASTE, DENTIFRICE TOPICAL 20100401 OTC MONOGRAPH FINAL part355 Melaleuca, Inc. SODIUM FLUORIDE .2592 g/108g N 20181231 54473-205_8b6e3ddd-a186-451d-9325-33955d161a7c 54473-205 HUMAN OTC DRUG Sensitive Tooth Polish Potassium Nitrate and Sodium Fluoride PASTE, DENTIFRICE TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part356 Melaleuca, Inc. SODIUM FLUORIDE; POTASSIUM NITRATE .26244; 5.4 g/108g; g/108g E 20171231 54473-206_6354bcb4-fef2-40c1-ac9b-6cda56e038ee 54473-206 HUMAN OTC DRUG Dermatin Antifungal CLOTRIMAZOLE CREAM TOPICAL 20111219 OTC MONOGRAPH FINAL part333C Melaleuca, Inc. CLOTRIMAZOLE .01 g/g E 20171231 54473-208_71b673cb-b7c9-4c48-b80a-f2a01c55250e 54473-208 HUMAN OTC DRUG BreathAway Mouth Rinse Cinnamon Cetylpyridinium Chloride MOUTHWASH TOPICAL 20110502 OTC MONOGRAPH NOT FINAL part356 Melaleuca, Inc. CETYLPYRIDINIUM CHLORIDE .3394 g/473mL E 20171231 54473-209_ec87c443-b19c-4a72-a158-8762b70f06fd 54473-209 HUMAN OTC DRUG BreathAway Mouth Rinse Fresh Mint Cetylpyridinium Chloride MOUTHWASH TOPICAL 20110502 OTC MONOGRAPH NOT FINAL part356 Melaleuca, Inc. CETYLPYRIDINIUM CHLORIDE .3394 g/473mL E 20171231 54473-212_0c735b37-5321-4523-99fa-f62acba87672 54473-212 HUMAN OTC DRUG Sun Shades Sport Plus Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY TOPICAL 20110430 OTC MONOGRAPH NOT FINAL part352 Melaleuca, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 4.7106; 25.553; 7.851; 15.702 g/177mL; g/177mL; g/177mL; g/177mL E 20171231 54473-214_326cf0c6-313a-1377-e054-00144ff88e88 54473-214 HUMAN OTC DRUG Sun Shades Lip Balm Butter Rum Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20121001 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g N 20181231 54473-215_cc3c3b14-4255-48af-b159-006dd18b147b 54473-215 HUMAN OTC DRUG Sun Shades Lip Balm Caramel Toffee Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20121001 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g E 20171231 54473-217_9348e193-f6dc-4fcb-b265-ada5c5b28ee0 54473-217 HUMAN OTC DRUG Sun Shades Lip Balm Strawberry Daiquiri Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20120801 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g E 20171231 54473-218_0081ac43-6c70-4ed9-862c-c3678f43f20b 54473-218 HUMAN OTC DRUG Sun Shades Mineral Plus Sunscreen with Zinc Oxide OCTISALATE 5%, OCTOCRYlENE 3%, ZINC OXIDE 10.5% LOTION TOPICAL 20121227 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTISALATE; OCTOCRYLENE; ZINC OXIDE 9.225; 5.535; 18.45 g/177mL; g/177mL; g/177mL E 20171231 54473-219_b70e66c8-e775-4957-a768-db96b430410d 54473-219 HUMAN OTC DRUG Sun Shades Lip Balm Vanilla Bean Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g E 20171231 54473-220_c0f77434-4cd8-4a23-8a9b-199fb1663e87 54473-220 HUMAN OTC DRUG Sun Shades Lip Balm Mountain Mint Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g E 20171231 54473-221_054983e5-faf3-43cc-992d-87f4bdfa0c90 54473-221 HUMAN OTC DRUG Clarity Clear Skin Essentials Deep-Cleaning Astringent SALICYLIC ACID LIQUID TOPICAL 20120913 OTC MONOGRAPH FINAL part333D Melaleuca, Inc. SALICYLIC ACID .623 g/130mL E 20171231 54473-222_f432fa28-358b-4bc1-915d-2f22111c4d70 54473-222 HUMAN OTC DRUG Clarity Clear Skin Essentials Foaming Cleanser SALICYLIC ACID LIQUID TOPICAL 20120913 OTC MONOGRAPH FINAL part333D Melaleuca, Inc. SALICYLIC ACID .691 g/133mL E 20171231 54473-223_2d72a9b9-3680-4196-986c-d7bdeee8a3a5 54473-223 HUMAN OTC DRUG Clarity Clear Skin Essentials Acne treatment SALICYLIC ACID CREAM TOPICAL 20120913 OTC MONOGRAPH FINAL part333D Melaleuca Inc. SALICYLIC ACID .28 g/14g E 20171231 54473-224_20a327ba-08cb-4727-80a0-25201ce4f9e9 54473-224 HUMAN OTC DRUG Affinia Facial Moisturizer AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20120801 OTC MONOGRAPH FINAL part352 Melaleuca, Inc. HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 7.296; 6.08; 3.648; 2.1888 g/120mL; g/120mL; g/120mL; g/120mL E 20171231 54473-225_af77b589-e3e6-4b6a-bdee-48af76b73165 54473-225 HUMAN OTC DRUG Clarity Clear Skin Essentials Acne Spot Treatment SALICYLIC ACID CREAM TOPICAL 20120913 OTC MONOGRAPH FINAL part333D Melaleuca Inc. SALICYLIC ACID .156 g/8.9mL E 20171231 54473-226_14053139-b0ff-4c92-a424-31f854704127 54473-226 HUMAN OTC DRUG Sun Shades Lip Balm Pina Colada Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g E 20171231 54473-227_e4aa4d77-561f-4f66-89da-a18b51f343d8 54473-227 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Almond Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-228_7f507b5b-d366-4db5-baa8-1a84b9bdb111 54473-228 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Beige Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-229_b4b6cf34-f587-4fee-b8d1-ff7e71ea0b84 54473-229 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Cashmere Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-230_93748db7-e35d-4994-a49a-2024a6d00608 54473-230 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Chestnut Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-231_0f7dc9ed-652a-46d9-890d-5cc9df3fb778 54473-231 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Classic Beige Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-232_4cf384ac-ffcf-4b43-a825-40b4b6286d37 54473-232 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Espresso Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-233_ba5c46a9-89ef-4968-92c9-9f31349f41f9 54473-233 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Fawn Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-234_8d798921-7ded-4799-9277-f1f34b9bf7b5 54473-234 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Golden Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-235_c7a0484d-4faf-41b9-9d39-31601a9727e1 54473-235 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Ivory Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-236_0dba512d-2aaf-4be1-a167-a41915b0fd1c 54473-236 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Natural Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-237_0ca2e191-6cd2-45f7-93de-6c490e01ecbb 54473-237 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Porcelain Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-238_378df598-56f2-4f2f-b4dd-c388136b13b8 54473-238 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Sand Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-239_ffa21c02-a979-412b-a07b-958f14835a0c 54473-239 HUMAN OTC DRUG Sei Bella Age-Defying Liquid Foundation Toffee Octinoxate 7.5% LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. OCTINOXATE 2.25 g/30mL E 20171231 54473-241_3191f551-b518-51f2-e054-00144ff88e88 54473-241 HUMAN OTC DRUG Sheer Confidence Antiperspirant Deodorant Moonlit Orchid Aluminum zirconium tetrachlorohydrex gly (19% Anhydrous) STICK TOPICAL 20130501 OTC MONOGRAPH FINAL part350 Melaleuca Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/57g E 20171231 54473-242_3191c9dc-bf6f-0591-e054-00144ff8d46c 54473-242 HUMAN OTC DRUG Sheer Confidence Antiperspirant Deodorant aribbean Sunset Aluminum zirconium tetrachlorohydrex gly (19% Anhydrous) STICK TOPICAL 20130501 OTC MONOGRAPH FINAL part350 Melaleuca Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 10.83 g/57g E 20171231 54473-243_319103c5-5752-2877-e054-00144ff88e88 54473-243 HUMAN OTC DRUG Sheer Confidence Antiperspirant Deodorant Perfect Powder Aluminum zirconium tetrachlorohydrex gly (19% Anhydrous) STICK TOPICAL 20130501 OTC MONOGRAPH FINAL part350 Melaleuca Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/57g E 20171231 54473-244_89623eb0-745a-432a-afa0-1ca27bcfcf5b 54473-244 HUMAN OTC DRUG Sun Shades Lip Balm Sugar and Spice Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g E 20171231 54473-245_326cf0c6-3139-1377-e054-00144ff88e88 54473-245 HUMAN OTC DRUG Sun Shades Lip Balm Peach Mango Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g N 20181231 54473-246_c8169cea-60ee-48c6-915d-ecc7038b03db 54473-246 HUMAN OTC DRUG Sun Shades Lip Balm Watermelon Lemon Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g E 20171231 54473-247_7384e471-b97e-4b83-892b-42b12d69ef51 54473-247 HUMAN OTC DRUG Sei Bella Skin Refining Tinted Moisturizer Procelain Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Melaleuca Inc. TITANIUM DIOXIDE 2.866 g/44.4mL E 20171231 54473-248_e99547a1-a44b-45e5-ada9-90321c09d4d8 54473-248 HUMAN OTC DRUG Sei Bella Skin Refining Tinted Moisturizer Classic Beige Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Melaleuca Inc. TITANIUM DIOXIDE 2.866 g/44.4mL E 20171231 54473-249_9b617e39-2ebc-4e49-890f-4baeea7ca526 54473-249 HUMAN OTC DRUG Sei Bella Skin Refining Tinted Moisturizer Fawn Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Melaleuca Inc. TITANIUM DIOXIDE 2.866 g/44.4mL E 20171231 54473-250_9aa1c49f-bbfc-4652-859c-0d82f43afb45 54473-250 HUMAN OTC DRUG Sei Bella Skin Refining Tinted Moisturizer Natural Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Melaleuca Inc. TITANIUM DIOXIDE 2.866 g/44.4mL E 20171231 54473-251_3b019caa-1834-4f15-bd75-234851e86fdc 54473-251 HUMAN OTC DRUG Sei Bella Skin Refining Tinted Moisturizer Tan Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Melaleuca Inc. TITANIUM DIOXIDE 2.866 g/44.4mL E 20171231 54473-254_c7e58acc-fd69-4c28-9028-0094684e1fb6 54473-254 HUMAN OTC DRUG Sun Shades Lip Balm Strawberry Tart Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g E 20171231 54473-255_326cf0c6-3138-1377-e054-00144ff88e88 54473-255 HUMAN OTC DRUG Sun Shades Lip Balm STropical Fruit Sorbet Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g N 20181231 54473-256_0cc1a4b4-ee2c-4379-a987-3b206b245a54 54473-256 HUMAN OTC DRUG Sun Shades Lip Balm Pink Grapefruit Avobenzone, Octinoxate, Oxybenzone STICK TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g E 20171231 54473-257_2d1f38b6-0d31-454c-a37c-2cf781514d5d 54473-257 HUMAN OTC DRUG Sun Shades Lip Balm Key Lime Pie Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g E 20171231 54473-258_244e2a79-cfb4-4c82-acbd-43942a9c1e6c 54473-258 HUMAN OTC DRUG Clear Defense Citrus Sage Ethyl alcohol GEL TOPICAL 20140515 OTC MONOGRAPH NOT FINAL part333A Melaleuca Inc ALCOHOL 36.58 g/59mL E 20171231 54473-259_4f32367d-c49e-2662-e054-00144ff88e88 54473-259 HUMAN OTC DRUG Sun Shades Lip Balm Coconut Smoothie Avobenzone, Octinoxate, Oxybenzone STICK TOPICAL 20150514 OTC MONOGRAPH FINAL part352 Melaleuca Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g N 20181231 54473-261_32329d9d-5b72-5cdf-e054-00144ff8d46c 54473-261 HUMAN OTC DRUG Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 Blush 140 C Avobenzone and Octinoxate LOTION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Melaleuca Inc AVOBENZONE; OCTINOXATE 1.389; 3.473 g/44.4mL; g/44.4mL E 20171231 54473-262_32329d9d-5b73-5cdf-e054-00144ff8d46c 54473-262 HUMAN OTC DRUG Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 Blush 160 N Avobenzone and Octinoxate LOTION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Melaleuca Inc OCTINOXATE; AVOBENZONE 3.473; 1.389 g/44.4mL; g/44.4mL E 20171231 54473-263_3232a4c9-5c4f-2eef-e054-00144ff88e88 54473-263 HUMAN OTC DRUG Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 Blush 200 W Avobenzone and Octinoxate LOTION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Melaleuca Inc AVOBENZONE; OCTINOXATE 1.389; 3.473 g/44.4mL; g/44.4mL E 20171231 54473-264_3232c95f-7667-5a34-e054-00144ff8d46c 54473-264 HUMAN OTC DRUG Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 Blush 220 C Avobenzone and Octinoxate LOTION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Melaleuca Inc AVOBENZONE; OCTINOXATE 1.389; 3.473 g/44.4mL; g/44.4mL E 20171231 54473-265_32329d9d-5bab-5cdf-e054-00144ff8d46c 54473-265 HUMAN OTC DRUG Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 Beige 300 N Avobenzone and Octinoxate LOTION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Melaleuca Inc AVOBENZONE; OCTINOXATE 1.389; 3.473 g/44.4mL; g/44.4mL E 20171231 54473-266_3233082a-3e2d-7248-e054-00144ff8d46c 54473-266 HUMAN OTC DRUG Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 Beige 320 W Avobenzone and Octinoxate LOTION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Melaleuca Inc AVOBENZONE; OCTINOXATE 1.389; 3.473 g/44.4mL; g/44.4mL E 20171231 54473-267_3233082a-3e2c-7248-e054-00144ff8d46c 54473-267 HUMAN OTC DRUG Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 Beige 340 N Avobenzone and Octinoxate LOTION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Melaleuca Inc AVOBENZONE; OCTINOXATE 1.389; 3.473 g/44.4mL; g/44.4mL E 20171231 54473-268_3233237a-cfb4-0124-e054-00144ff8d46c 54473-268 HUMAN OTC DRUG Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 Tan 440 C Avobenzone and Octinoxate LOTION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Melaleuca Inc AVOBENZONE; OCTINOXATE 1.389; 3.473 g/44.4mL; g/44.4mL E 20171231 54473-269_3233082a-3e2e-7248-e054-00144ff8d46c 54473-269 HUMAN OTC DRUG Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 Tan 500 W Avobenzone and Octinoxate LOTION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Melaleuca Inc AVOBENZONE; OCTINOXATE 1.389; 3.473 g/44.4mL; g/44.4mL E 20171231 54473-270_3232bb78-f4e5-2fa4-e054-00144ff88e88 54473-270 HUMAN OTC DRUG Sei Bella Tinted BB Moisturizing Creme Broadspectrum SPF 20 Deep 560 C Avobenzone and Octinoxate LOTION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Melaleuca Inc AVOBENZONE; OCTINOXATE 1.389; 3.473 g/44.4mL; g/44.4mL E 20171231 54473-578_91649003-07b6-4620-a513-dcd1edc3ae32 54473-578 HUMAN OTC DRUG Triple Antibiotic Bacitracin zinc and Neomycin and Polymyxin B sulfate OINTMENT TOPICAL 19950701 OTC MONOGRAPH FINAL part333B Melaleuca, Inc. BACITRACIN ZINC; NEOMYCIN; POLYMYXIN B SULFATE 500; 3.5; 10000 [iU]/g; mg/g; [iU]/g E 20171231 54476-100_4d859414-bd74-4b2e-9f42-e2de329af2b6 54476-100 HUMAN OTC DRUG Hidocomo Antiseptic Disinfectant CHLOROXYLENOL LIQUID TOPICAL 20130117 OTC MONOGRAPH NOT FINAL part333E Toma Biotechnology International Corporation-China Division CHLOROXYLENOL 3.5 g/100mL E 20171231 54482-020_74fc5a6f-016e-4c9f-b096-cd156ad612ca 54482-020 HUMAN PRESCRIPTION DRUG CYSTARAN cysteamine hydrochloride SOLUTION OPHTHALMIC 20121230 NDA NDA200740 Leadiant Biosciences, Inc. CYSTEAMINE HYDROCHLORIDE 6.5 mg/mL Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] N 20181231 54482-053_2ad0d8b4-f587-4ad2-b8a3-578f8fa61106 54482-053 HUMAN PRESCRIPTION DRUG Matulane procarbazine hydrochloride CAPSULE ORAL 19851227 NDA NDA016785 Sigma-Tau Pharmaceuticals, Inc. PROCARBAZINE HYDROCHLORIDE 50 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 54482-144_ba1d3b8d-20d3-43b1-8f19-848f28d1ceb9 54482-144 HUMAN PRESCRIPTION DRUG CARNITOR levocarnitine TABLET ORAL 19851227 NDA NDA018948 Leadiant Biosciences, Inc. LEVOCARNITINE 330 mg/1 Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] N 20181231 54482-145_d9b2c7a7-ceb5-48dc-b07b-5906e57c6b3c 54482-145 HUMAN PRESCRIPTION DRUG Carnitor levocarnitine SOLUTION ORAL 19860410 NDA NDA019257 Leadiant Biosciences, Inc. LEVOCARNITINE 1 g/10mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] N 20181231 54482-147_1a304a1a-d357-4944-b8d1-7c3bd4c29509 54482-147 HUMAN PRESCRIPTION DRUG Carnitor levocarnitine INJECTION, SOLUTION INTRAVENOUS 19921216 NDA NDA020182 Leadiant Biosciences, Inc. LEVOCARNITINE 1 g/5mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] N 20181231 54482-148_1d1032c7-044a-4240-bfe7-0bd17bf64da4 54482-148 HUMAN PRESCRIPTION DRUG Carnitor SF levocarnitine SOLUTION ORAL 19860410 NDA NDA019257 Leadiant Biosciences, Inc. LEVOCARNITINE 1 g/10mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] N 20181231 54483-0001_29c43bba-5511-495a-a108-6603acddcf61 54483-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860506 UNAPPROVED MEDICAL GAS Air-Way Medical, Inc. OXYGEN 99 L/100L E 20171231 54494-001_72a3c003-7900-4f08-9d37-e0ad241975df 54494-001 HUMAN OTC DRUG E MEI SHAN MEDICATED Camphor, Menthol, Methyl Salicylate PLASTER TRANSDERMAL 20130219 OTC MONOGRAPH NOT FINAL part348 SICHUAN EMEISHAN PHARMACEUTICAL CO., LTD. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 36; 30; 119 mg/1; mg/1; mg/1 N 20181231 54505-101_8581ef6f-6dfb-4788-97b5-0842117ae393 54505-101 HUMAN PRESCRIPTION DRUG epinephrine epinephrine INJECTION SUBCUTANEOUS 20100401 20180430 NDA AUTHORIZED GENERIC NDA020800 Lineage Therapeutics Inc EPINEPHRINE .15 mg/.15mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 54505-102_8581ef6f-6dfb-4788-97b5-0842117ae393 54505-102 HUMAN PRESCRIPTION DRUG epinephrine epinephrine INJECTION SUBCUTANEOUS 20100401 20180531 NDA AUTHORIZED GENERIC NDA020800 Lineage Therapeutics Inc EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 54505-327_2358a5cc-6ff3-4a47-a64d-afa79f218e10 54505-327 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA AUTHORIZED GENERIC NDA017078 Lineage Therapeutics Inc DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54505-328_2358a5cc-6ff3-4a47-a64d-afa79f218e10 54505-328 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA AUTHORIZED GENERIC NDA017078 Lineage Therapeutics Inc DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54505-329_2358a5cc-6ff3-4a47-a64d-afa79f218e10 54505-329 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 19760802 NDA AUTHORIZED GENERIC NDA017078 Lineage Therapeutics Inc DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 54505-331_e8920ed9-6d8c-436e-a1e2-01d3bdb19108 54505-331 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20070330 20190831 ANDA ANDA040646 Lineage Therapeutics Inc HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54505-332_e8920ed9-6d8c-436e-a1e2-01d3bdb19108 54505-332 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20070330 20191130 ANDA ANDA040646 Lineage Therapeutics Inc HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54505-333_e8920ed9-6d8c-436e-a1e2-01d3bdb19108 54505-333 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20070330 20190930 ANDA ANDA040646 Lineage Therapeutics Inc HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54528-001_5f89b9f3-7a38-3109-e053-2991aa0a3a2f 54528-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20141031 UNAPPROVED MEDICAL GAS Commonwealth Home Health Care, Inc. OXYGEN 995 mL/L N 20181231 54531-100_c0dda789-4173-431d-9d0a-8648da6e0c91 54531-100 HUMAN PRESCRIPTION DRUG Minocin minocycline hydrochloride INJECTION INTRAVENOUS 20130419 NDA NDA050444 Rempex Pharmaceuticals, Inc MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 54532-0010_f8788071-e48e-4444-bb57-d65c636ceeff 54532-0010 HUMAN OTC DRUG Hevert Stress Relief BLACK COHOSH, ANAMIRTA COCCULUS SEED, CYPRIPEDIUM PARVIFOLUM ROOT, STRYCHNOS IGNATII SEED, LILIUM LANCIFOLIUM FLOWERING TOP, PASSIFLORA INCARNATA FLOWERING TOP, PLATINUM, VALERIAN, and ZINC VALERATE DIHYDRATE TABLET ORAL 20130215 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC BLACK COHOSH; ANAMIRTA COCCULUS SEED; CYPRIPEDIUM PARVIFOLUM ROOT; STRYCHNOS IGNATII SEED; LILIUM LANCIFOLIUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PLATINUM; VALERIAN; ZINC VALERATE DIHYDRATE 4; 6; 6; 6; 6; 3; 8; 2; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54532-0012_3a769059-5cbb-4687-96d5-90c745fb6b15 54532-0012 HUMAN OTC DRUG Hevert Allergy Relief APIS MELLIFERA, GALPHIMIA GLAUCA WHOLE, POTASSIUM DICHROMATE, TEUCRIUM MARUM TOP, and VERBASCUM DENSIFLORUM Flowering Top TABLET ORAL 20130201 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC APIS MELLIFERA; GALPHIMIA GLAUCA WHOLE; POTASSIUM DICHROMATE; TEUCRIUM MARUM TOP; VERBASCUM DENSIFLORUM FLOWERING TOP 4; 4; 6; 4; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54532-0013_7ab6ac6f-4d85-4a38-a743-058667a2dc82 54532-0013 HUMAN OTC DRUG Hevert Motion Sickness Relief ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, and TOBACCO LEAF TABLET ORAL 20130201 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; TOBACCO LEAF 4; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54532-0014_b03ba873-b5d8-4850-9781-890eda0294ca 54532-0014 HUMAN OTC DRUG Hevert Pain Relief ARNICA MONTANA ROOT and TOXICODENDRON PUBESCENS SHOOT TABLET ORAL 20130215 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ARNICA MONTANA ROOT; TOXICODENDRON PUBESCENS SHOOT 4; 6 [hp_X]/1; [hp_X]/1 N 20181231 54532-0015_60ae1b36-b2d1-4d6d-b6f5-e79a525830af 54532-0015 HUMAN OTC DRUG Hevert Cough Relief drosera rotundifolia, drosera intermedia, drosera anglica, eriodictyon californicum flowering top, grindelia hirsutula flowering top, potassium iodide, spongia officinalis skeleton, roasted, lobaria pulmonaria, teucrium scorodonia flowering top, and verbascum densiflorum flowering top TABLET ORAL 20130307 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC DROSERA ROTUNDIFOLIA; DROSERA INTERMEDIA; DROSERA ANGLICA; ERIODICTYON CALIFORNICUM FLOWERING TOP; GRINDELIA HIRSUTULA FLOWERING TOP; POTASSIUM IODIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; LOBARIA PULMONARIA; TEUCRIUM SCORODONIA FLOWERING TOP; VERBASCUM DENSIFLORUM FLOWERING TOP 4; 4; 4; 2; 4; 3; 4; 3; 3; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54532-0016_a260e60c-d9c6-41c8-ad6e-94f035eda06e 54532-0016 HUMAN OTC DRUG Hevert Cold and Flu Relief ACONITUM NAPELLUS, AMMONIUM BROMIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, ECHINACEA, UNSPECIFIED, MERCURIC CYANIDE, and TOXICODENDRON PUBESCENS SHOOT TABLET ORAL 20130510 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ACONITUM NAPELLUS; AMMONIUM BROMIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; MERCURIC CYANIDE; TOXICODENDRON PUBESCENS SHOOT 6; 4; 6; 6; 6; 3; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54532-0017_ddc87ab3-55b2-4c61-812f-39df0d309816 54532-0017 HUMAN OTC DRUG Hevert Gastrointestinal Relief BISMUTH SUBNITRATE, ACTIVATED CHARCOAL, IPECAC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and STRYCHNOS NUX-VOMICA SEED TABLET ORAL 20141216 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED 6; 3; 6; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54532-0018_e6fb8472-a338-4690-a395-22ec765b00cd 54532-0018 HUMAN OTC DRUG Hevert Detox Intestinum Eichhornia Crassipes Whole, OKOUBAKA AUBREVILLEI BARK, QUASSIA AMARA WOOD, and TARAXACUM PALUSTRE ROOT LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC EICHHORNIA CRASSIPES WHOLE; OKOUBAKA AUBREVILLEI BARK; QUASSIA AMARA WOOD; TARAXACUM PALUSTRE ROOT 1; 2; 1; 1 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 54532-0019_b12aa055-00a8-4b69-b601-4234fcea1b12 54532-0019 HUMAN OTC DRUG Hevert Detox Kidney Nitric Acid, Apis Cerana Whole, Atropa Belladonna, Lytta Vesicatoria, Juniperus Communis Whole, and Solidago Virgaurea Flowering Top LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC NITRIC ACID; APIS CERANA WHOLE; ATROPA BELLADONNA; LYTTA VESICATORIA; JUNIPERUS COMMUNIS WHOLE; SOLIDAGO VIRGAUREA FLOWERING TOP 6; 3; 6; 4; 3; 1 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 54532-0020_7b8c20ad-40da-4cd4-84cc-caa12f68707a 54532-0020 HUMAN OTC DRUG Hevert Detox Liver Milk Thistle, Chelidonium Majus Root, and Taraxacum Palustre Root LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC MILK THISTLE; CHELIDONIUM MAJUS ROOT; TARAXACUM PALUSTRE ROOT 1; 3; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 54532-0021_c03112f2-4c6e-4f31-aa80-8b1ebc492d0a 54532-0021 HUMAN OTC DRUG Hevert Detox Lymph Arsenic Trioxide, Clematis Recta Flowering top, Conium Maculatum Flowering Top, Lachesis Muta Venom, Mercuric Iodide, Phytolacca Americana Root, Toxicodendron Pubescens Leaf, Scrophularia Nodosa, and Sulfur LIQUID ORAL 20140801 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ARSENIC TRIOXIDE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; LACHESIS MUTA VENOM; MERCURIC IODIDE; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SCROPHULARIA NODOSA; SULFUR 6; 4; 6; 8; 8; 4; 6; 3; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 54532-0022_ade45c16-519c-42b4-9802-5f11453ff7a5 54532-0022 HUMAN OTC DRUG Hevert Sinus Relief APIS MELLIFERA, BAPTISIA TINCTORIA, ECHINACEA, UNSPECIFIED, CALCIUM SULFIDE, POTASSIUM DICHROMATE, LACHESIS MUTA VENOM, LUFFA OPERCULATA FRUIT, MERCURIC IODIDE, MERCURIC SULFIDE, SILICON DIOXIDE, and SPONGIA OFFICINALIS SKELETON, ROASTED TABLET ORAL 20150701 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC APIS MELLIFERA; BAPTISIA TINCTORIA; ECHINACEA, UNSPECIFIED; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LUFFA OPERCULATA FRUIT; MERCURIC IODIDE; MERCURIC SULFIDE; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED 4; 4; 2; 4; 8; 8; 6; 9; 6; 2; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54532-0023_54e7ed9d-3984-4e60-9a50-4fe0e0d4207f 54532-0023 HUMAN OTC DRUG Hevert Menopause Relief chaste tree, black cohosh, lilium lancifolium flowering top, and platinum TABLET ORAL 20150915 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC CHASTE TREE; BLACK COHOSH; LILIUM LANCIFOLIUM FLOWERING TOP; PLATINUM 2; 2; 2; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54532-0024_0102088c-6c89-4200-9003-ffda1f115fe1 54532-0024 HUMAN OTC DRUG Hevert Trauma Roll-On Arnica Montana Root, Bellis Perennis, Calendula Officinalis Flowering Top, Hamamelis Virginiana Root Bark/Stem Bark, Hypericum Perforatum, Achillea Millefolium Flowering Top, Ruta Graveolens Flowering Top, and Comfrey Root GEL TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ARNICA MONTANA ROOT; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM FLOWERING TOP; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 3; 1; 1; 1; 6; 1; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54532-0025_63624914-6d93-4655-a51c-b3e16a4d2391 54532-0025 HUMAN PRESCRIPTION DRUG Hevert Arnica ARNICA MONTANA ROOT INJECTION INTRAVENOUS 20160601 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ARNICA MONTANA ROOT 4 [hp_X]/2mL N 20181231 54532-0027_00299110-d917-4667-a7a8-d20c50d3a9e0 54532-0027 HUMAN PRESCRIPTION DRUG Hevert Gelsemium comp aconitum napellus, anamirta cocculus seed, citrullus colocynthis fruit, gelsemium sempervirens root, lachesis muta venom, daphne mezereum bark, strychnos nux-vomica seed, lead acetate anhydrous, and toxicodendron pubescens shoot INJECTION INTRAVENOUS 20160601 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ACONITUM NAPELLUS; ANAMIRTA COCCULUS SEED; CITRULLUS COLOCYNTHIS FRUIT; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; LEAD ACETATE ANHYDROUS; TOXICODENDRON PUBESCENS SHOOT 4; 4; 4; 4; 12; 6; 6; 6; 6 [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 54532-0028_29aef503-afc6-4655-97f4-f533d3d64d03 54532-0028 HUMAN PRESCRIPTION DRUG Hevert Hepar comp. MILK THISTLE, CHELIDONIUM MAJUS ROOT, QUASSIA AMARA WOOD, and TARAXACUM OFFICINALE INJECTION INTRAVENOUS 20160601 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC MILK THISTLE; CHELIDONIUM MAJUS ROOT; QUASSIA AMARA WOOD; TARAXACUM OFFICINALE 4; 6; 4; 4 [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL N 20181231 54532-0029_14f210f1-3a20-4161-995d-3084f1bf141f 54532-0029 HUMAN PRESCRIPTION DRUG Hevert Lymphaden comp. Arsenic Trioxide, Clematis Recta Flowering Top, Lachesis Muta Venom, Mercuric Cyanide, Phytolacca Americana Root, Toxicodendron Pubescens Shoot, Scrophularia Nodosa Leaf With Stem, Sulfur, and Thuja Occidentalis Leafy Twig INJECTION INTRAVENOUS 20160601 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ARSENIC TRIOXIDE; CLEMATIS RECTA FLOWERING TOP; LACHESIS MUTA VENOM; MERCURIC CYANIDE; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS SHOOT; SCROPHULARIA NODOSA LEAF WITH STEM; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 6; 4; 8; 8; 6; 6; 4; 6; 4 [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL N 20181231 54532-0030_0d74be69-9719-43d2-98e3-fb9dbeadd134 54532-0030 HUMAN OTC DRUG HEVERT DETOX Arsenic Trioxide, Clematis Recta Flowering top, Conium Maculatum Flowering Top, Lachesis Muta Venom, Mercuric Iodide, Phytolacca Americana Root, Toxicodendron Pubescens shoot, Scrophularia Nodosa leaf with stem, Sulfur, Milk Thistle, Chelidonium majus root, Taraxacum officinale, Nitric Acid, Apis Mellifera, Atropa Belladonna, Lytta Vesicatoria, Juniper Berry, Solidago Virgaurea Flowering Top, Eichhornia Crassipes Whole, Okoubaka aubrevillei bark, QUASSIA AMARA WOOD, and TARAXACUM OFFICINALE KIT 20160915 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC N 20181231 54532-0031_26282bfb-fa8a-4a58-a9e5-359739a2ba7d 54532-0031 HUMAN OTC DRUG Hevert Detox Intestinum Eichhornia Crassipes Whole, OKOUBAKA AUBREVILLEI BARK, QUASSIA AMARA WOOD, and TARAXACUM OFFICINALE LIQUID ORAL 20160615 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC EICHHORNIA CRASSIPES WHOLE; OKOUBAKA AUBREVILLEI BARK; QUASSIA AMARA WOOD; TARAXACUM OFFICINALE 1; 2; 1; 1 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 54532-0032_aa608f1f-135f-47e6-bf4c-858fdf49e6b1 54532-0032 HUMAN OTC DRUG Hevert Detox Kidney Nitric Acid, Apis Mellifera, Atropa Belladonna, Lytta Vesicatoria, Juniper Berry, and Solidago Virgaurea Flowering Top LIQUID ORAL 20160615 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC NITRIC ACID; APIS MELLIFERA; ATROPA BELLADONNA; LYTTA VESICATORIA; JUNIPER BERRY; SOLIDAGO VIRGAUREA FLOWERING TOP 6; 3; 6; 4; 3; 1 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 54532-0033_8cf377cc-3014-4ffa-a7e9-149be3e59e67 54532-0033 HUMAN OTC DRUG Hevert Detox Liver Milk Thistle, Chelidonium Majus Root, and Taraxacum officinale LIQUID ORAL 20160615 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC MILK THISTLE; CHELIDONIUM MAJUS ROOT; TARAXACUM OFFICINALE 1; 3; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20191231 54532-0034_142bd59d-505a-48fd-939e-ed0efccb912e 54532-0034 HUMAN OTC DRUG Hevert Detox Lymph Arsenic Trioxide, Clematis Recta Flowering top, Conium Maculatum Flowering Top, Lachesis Muta Venom, Mercuric Iodide, Phytolacca Americana Root, Toxicodendron Pubescens shoot, Scrophularia Nodosa leaf with stem, and Sulfur LIQUID ORAL 20160615 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC ARSENIC TRIOXIDE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; LACHESIS MUTA VENOM; MERCURIC IODIDE; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS SHOOT; SCROPHULARIA NODOSA LEAF WITH STEM; SULFUR 6; 4; 6; 8; 8; 4; 6; 3; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 54532-0036_f96f3a26-9daf-4fe9-a869-cde3baa7418c 54532-0036 HUMAN PRESCRIPTION DRUG Hevert Calmvalera comp. black cohosh, anamirta cocculus seed, cypripedium parvifolum root, strychnos ignatii seed, passiflora incarnata flowering top, platinum, valerian, and zinc valerate dihydrate INJECTION INTRAVENOUS 20160801 UNAPPROVED HOMEOPATHIC Hevert Pharmaceuticals LLC BLACK COHOSH; ANAMIRTA COCCULUS SEED; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; PLATINUM; VALERIAN; ZINC VALERATE DIHYDRATE 4; 4; 4; 6; 4; 10; 4; 8 [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL N 20181231 54557-0001_ec5f6bed-f368-42e7-94fa-b91b36aed9b4 54557-0001 HUMAN OTC DRUG ARTHRITIS CARE Colchicum Autumnale, Propolis, Kalmia Latifolia, Bryonia, Causticum, Kali Carbonicum, Ledum Palustre, Rhododendron Chrysanthum, GEL TOPICAL 20130809 UNAPPROVED HOMEOPATHIC MedCare Group LLC COLCHICUM AUTUMNALE BULB; PROPOLIS WAX; KALMIA LATIFOLIA LEAF; BRYONIA ALBA ROOT; CAUSTICUM; POTASSIUM CARBONATE; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54557-0002_49d48a78-c01f-49bf-aa80-354351f2cf23 54557-0002 HUMAN OTC DRUG Bruises Gone Gel Calendula Officinalis, Arnica Montana, Hypericum Perforatum, Symphytum Officinale, Bellis Perennis, Ledum Palustre, Sulphuricum Acidum GEL TOPICAL 20130808 UNAPPROVED HOMEOPATHIC MedCare Group LLC CALENDULA OFFICINALIS FLOWERING TOP; ARNICA MONTANA; HYPERICUM PERFORATUM; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; SULFURIC ACID; CALCIUM FLUORIDE; FERRUM PHOSPHORICUM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SODIUM SULFATE 1; 1; 1; 3; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 54557-0003_6eaf781f-f407-45ed-af51-78cc01dff2e9 54557-0003 HUMAN OTC DRUG Nasal Guard Ammonium Carbonicum, Arsenicum Album, hepar Sulphuris Calcareum, Iodium, Lycopodium Clavatum, Nux Vomica, Pulsatilla, LIQUID NASAL 20130827 UNAPPROVED HOMEOPATHIC Medcare Group LLC AMMONIUM CARBONATE; ARSENIC TRIOXIDE; CALCIUM SULFIDE; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54565-1303_5d6920e4-60e1-1071-e053-2991aa0a853e 54565-1303 HUMAN OTC DRUG Aveeno Baby Daily Moisture Dimethicone LOTION TOPICAL 20101201 OTC MONOGRAPH FINAL part347 Les Emballages Knowlton Inc DIMETHICONE 12 mg/mL N 20181231 54565-1907_5d8e0e94-b8e7-56db-e053-2991aa0a410f 54565-1907 HUMAN OTC DRUG Dove DermaSeries Eczema Relief Soothing Body Colloidal Oatmeal LOTION TOPICAL 20170713 OTC MONOGRAPH FINAL part347 Les Emballages Knowlton Inc. OATMEAL 1 g/100mL N 20181231 54565-1908_5d8e5726-5402-898c-e053-2991aa0aca76 54565-1908 HUMAN OTC DRUG Dove DermaSeries Dry Skin Relief Replenishing Face Cream SPF 15 Avobenzone,Ensulizole, Octisalate, Octocrylene CREAM TOPICAL 20170712 OTC MONOGRAPH NOT FINAL part352 Les Emballages Knowlton Inc. AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 2; 1.5; 5; 1.3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 54565-2205_5d8dc8da-2d2a-7b0b-e053-2a91aa0a7279 54565-2205 HUMAN OTC DRUG Ban Invisible Solid Antiperspirant Deodorant Shower Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20111229 OTC MONOGRAPH FINAL part350 Les Emballages Knowlton Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 13.87 g/73g N 20181231 54565-3201_5d1a0d37-af89-d56e-e053-2991aa0a97d5 54565-3201 HUMAN OTC DRUG Herpecin L Dimethicone and Meradimate and Octinoxate and Octisalate and Oxybenzone STICK TOPICAL 20171103 OTC MONOGRAPH NOT FINAL part352 Les Emballages Knolwton Inc. DIMETHICONE; MERADIMATE; OCTINOXATE; OCTISALATE; OXYBENZONE 1; 5; 7.5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 54565-3901_5df71189-9b37-9dee-e053-2a91aa0a9e49 54565-3901 HUMAN OTC DRUG Kiehls CrossTerrain Antiperspirant Deodorant 24 Hour Strong Dry Aluminum Chlorohydrate STICK TOPICAL 20171031 OTC MONOGRAPH FINAL part350 Les Emballages Knowlton Inc ALUMINUM CHLOROHYDRATE 15 g/75g N 20181231 54569-6137_7bb8333d-1eb8-49dc-816c-20caf9d2acfb 54569-6137 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090162 A-S Medication Solutions TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54575-081_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-081 HUMAN PRESCRIPTION DRUG BAHIA GRASS POLLEN paspalum notatum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PASPALUM NOTATUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-082_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-082 HUMAN PRESCRIPTION DRUG CULTIVATED BARLEY POLLEN hordeum vulgare pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. HORDEUM VULGARE POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-083_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-083 HUMAN PRESCRIPTION DRUG CREEPING BENT GRASS POLLEN agrostis stolonifera pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AGROSTIS STOLONIFERA POLLEN 1 g/20mL Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 54575-084_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-084 HUMAN PRESCRIPTION DRUG STANDARDIZED BERMUDA GRASS POLLEN Cynodon dactylon pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101379 Allergy Laboratories, Inc. CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-085_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-085 HUMAN PRESCRIPTION DRUG ANNUAL BLUEGRASS POLLEN poa annua pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POA ANNUA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-087_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-087 HUMAN PRESCRIPTION DRUG STANDARDIZED KENTUCKY BLUEGRASS POLLEN Poa pratensis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101380 Allergy Laboratories, Inc. POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-088_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-088 HUMAN PRESCRIPTION DRUG HUNGARIAN SMOOTH BROME POLLEN bromus inermis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BROMUS INERMIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-089_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-089 HUMAN PRESCRIPTION DRUG CANARY GRASS POLLEN phalaris minor pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PHALARIS MINOR POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-090_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-090 HUMAN PRESCRIPTION DRUG SOUTHERN CHEAT CHESS POLLEN bromus secalinus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BROMUS SECALINUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-091_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-091 HUMAN PRESCRIPTION DRUG CULTIVATED CORN POLLEN zea mays pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ZEA MAYS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-092_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-092 HUMAN PRESCRIPTION DRUG STANDARDIZED MEADOW FESCUE GRASS POLLEN Festuca elatior pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101381 Allergy Laboratories, Inc. FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-093_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-093 HUMAN PRESCRIPTION DRUG BLUE GRAMA GRASS bouteloua gracilis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BOUTELOUA GRACILIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-094_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-094 HUMAN PRESCRIPTION DRUG JOHNSON GRASS POLLEN sorghum halepense pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SORGHUM HALEPENSE POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-095_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-095 HUMAN PRESCRIPTION DRUG TALL OAT GRASS POLLEN arrhenatherum elatius pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARRHENATHERUM ELATIUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-096_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-096 HUMAN PRESCRIPTION DRUG CULTIVATED OATS POLLEN avena sativa pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AVENA SATIVA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-097_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-097 HUMAN PRESCRIPTION DRUG STANDARDIZED ORCHARD GRASS POLLEN Dactylis glomerata pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101382 Allergy Laboratories, Inc. DACTYLIS GLOMERATA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-098_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-098 HUMAN PRESCRIPTION DRUG QUACK GRASS POLLEN elymus repens pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ELYMUS REPENS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-099_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-099 HUMAN PRESCRIPTION DRUG STANDARDIZED REDTOP GRASS POLLEN Agrostis alba pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101383 Allergy Laboratories, Inc. AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-101_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-101 HUMAN PRESCRIPTION DRUG ITALIAN RYEGRASS POLLEN lolium perenne subsp. multiflorum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. LOLIUM PERENNE SUBSP. MULTIFLORUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-102_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-102 HUMAN PRESCRIPTION DRUG STANDARDIZED PERENNIAL RYEGRASS GRASS POLLEN Lolium perenne pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970625 BLA BLA101384 Allergy Laboratories, Inc. LOLIUM PERENNE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-104_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-104 HUMAN PRESCRIPTION DRUG GRAIN SORGHUM POLLEN sorghum bicolor subsp. bicolor pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SORGHUM BICOLOR SUBSP. BICOLOR POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-105_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-105 HUMAN PRESCRIPTION DRUG SUDAN GRASS POLLEN sorghum bicolor subsp. drummondii pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-106_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-106 HUMAN PRESCRIPTION DRUG STANDARDIZED SWEET VERNAL GRASS POLLEN Anthoxanthum odoratum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101385 Allergy Laboratories, Inc. ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-107_a3c0a62e-9b1b-41bf-9f8c-c0b58e36395c 54575-107 HUMAN PRESCRIPTION DRUG STANDARDIZED TIMOTHY GRASS POLLEN Phleum pratense pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19970529 BLA BLA101386 Allergy Laboratories, Inc. PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-109_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-109 HUMAN PRESCRIPTION DRUG CULTIVATED WHEAT POLLEN triticum aestivum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRITICUM AESTIVUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-110_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-110 HUMAN PRESCRIPTION DRUG WESTERN WHEAT POLLEN pascopyrum smithii pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PASCOPYRUM SMITHII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-113_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-113 HUMAN PRESCRIPTION DRUG ALFALFA POLLEN medicago sativa pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MEDICAGO SATIVA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-114_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-114 HUMAN PRESCRIPTION DRUG SWEET CLOVER POLLEN melilotus albus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MELILOTUS ALBUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-115_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-115 HUMAN PRESCRIPTION DRUG SUGAR BEET POLLEN beta vulgaris pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BETA VULGARIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-116_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-116 HUMAN PRESCRIPTION DRUG WESTERN JUNE GRASS POLLEN koeleria macrantha pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. KOELERIA MACRANTHA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-121_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-121 HUMAN PRESCRIPTION DRUG BROOMWEED POLLEN amphiachyris dracunculoides pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMPHIACHYRIS DRACUNCULOIDES POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-122_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-122 HUMAN PRESCRIPTION DRUG CARELESS WEED POLLEN amaranthus palmeri pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMARANTHUS PALMERI POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-123_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-123 HUMAN PRESCRIPTION DRUG COCKLEBUR POLLEN xanthium strumarium pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. XANTHIUM STRUMARIUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-126_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-126 HUMAN PRESCRIPTION DRUG YELLOW CURLY DOCK POLLEN rumex crispus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. RUMEX CRISPUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-127_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-127 HUMAN PRESCRIPTION DRUG FIREBUSH KOCHIA POLLEN kochia scoparia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. KOCHIA SCOPARIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-128_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-128 HUMAN PRESCRIPTION DRUG GOLDENROD POLLEN solidago canadensis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SOLIDAGO CANADENSIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-129_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-129 HUMAN PRESCRIPTION DRUG GREASEWOOD POLLEN sarcobatus vermiculatus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SARCOBATUS VERMICULATUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-130_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-130 HUMAN PRESCRIPTION DRUG GROUNDSEL TREE POLLEN baccharis halimifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BACCHARIS HALIMIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-131_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-131 HUMAN PRESCRIPTION DRUG NETTLE POLLEN urtica dioica pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. URTICA DIOICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-132_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-132 HUMAN PRESCRIPTION DRUG LAMBS QUARTERS POLLEN chenopodium album pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CHENOPODIUM ALBUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-133_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-133 HUMAN PRESCRIPTION DRUG BURWEED MARSHELDER POLLEN iva xanthifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. IVA XANTHIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-134_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-134 HUMAN PRESCRIPTION DRUG NARROWLEAF MARSHELDER POLLEN iva angustifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. IVA ANGUSTIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-135_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-135 HUMAN PRESCRIPTION DRUG ROUGH MARSHELDER POLLEN iva annua var. annua pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. IVA ANNUA VAR. ANNUA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-136_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-136 HUMAN PRESCRIPTION DRUG COMMON MUGWORT POLLEN artemisia vulgaris pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARTEMISIA VULGARIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-137_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-137 HUMAN PRESCRIPTION DRUG SPINY PIGWEED POLLEN amaranthus spinosus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMARANTHUS SPINOSUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-138_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-138 HUMAN PRESCRIPTION DRUG ROUGH REDROOT PIGWEED POLLEN amaranthus retroflexus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-139_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-139 HUMAN PRESCRIPTION DRUG PIGWEED MIX, ROUGH/SPINY POLLEN amaranthus retroflexus pollen and amaranthus spinosus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN .5; .5 g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-140_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-140 HUMAN PRESCRIPTION DRUG ENGLISH PLANTAIN POLLEN plantago lanceolata pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PLANTAGO LANCEOLATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-145_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-145 HUMAN PRESCRIPTION DRUG FALSE BUR RAGWEED POLLEN ambrosia acanthicarpa pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMBROSIA ACANTHICARPA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-146_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-146 HUMAN PRESCRIPTION DRUG GIANT RAGWEED POLLEN ambrosia trifida pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMBROSIA TRIFIDA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-147_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-147 HUMAN PRESCRIPTION DRUG STANDARDIZED SHORT RAGWEED POLLEN ambrosia artemisiifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19820126 BLA BLA101387 Allergy Laboratories, Inc. AMBROSIA ARTEMISIIFOLIA POLLEN 1 g/10mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-150_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-150 HUMAN PRESCRIPTION DRUG WESTERN RAGWEED POLLEN ambrosia psilostachya pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-153_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-153 HUMAN PRESCRIPTION DRUG 3-RAGWEED MIX, GIANT/SHORT/WESTERN POLLEN ambrosia psilostachya pollen and ambrosia trifida pollen and ambrosia artemisiifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN .33; .33; .34 g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-154_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-154 HUMAN PRESCRIPTION DRUG RUSSIAN THISTLE POLLEN salsola kali pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SALSOLA KALI POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-155_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-155 HUMAN PRESCRIPTION DRUG COMMON BIG SAGEBRUSH POLLEN artemisia tridentata pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARTEMISIA TRIDENTATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-158_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-158 HUMAN PRESCRIPTION DRUG PRAIRIE SAGE POLLEN artemisia frigida pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARTEMISIA FRIGIDA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-159_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-159 HUMAN PRESCRIPTION DRUG SAGE MIX, COMMON/DARK-LEAVED/DRAGON/PASTURE POLLEN artemisia ludoviciana pollen and artemisia tridentata pollen and artemisia dracunculus pollen and artemisia frigida pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA DRACUNCULUS POLLEN; ARTEMISIA FRIGIDA POLLEN .25; .25; .25; .25 g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-160_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-160 HUMAN PRESCRIPTION DRUG ANNUAL SALTBUSH POLLEN atriplex wrightii pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ATRIPLEX WRIGHTII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-161_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-161 HUMAN PRESCRIPTION DRUG SHADSCALE POLLEN atriplex confertifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ATRIPLEX CONFERTIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-162_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-162 HUMAN PRESCRIPTION DRUG SOUR DOCK SHEEP SORREL POLLEN rumex acetosella pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. RUMEX ACETOSELLA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 54575-163_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-163 HUMAN PRESCRIPTION DRUG WATER HEMP POLLEN amaranthus tuberculatus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMARANTHUS TUBERCULATUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-164_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-164 HUMAN PRESCRIPTION DRUG WINGSCALE POLLEN atriplex canescens pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ATRIPLEX CANESCENS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-166_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-166 HUMAN PRESCRIPTION DRUG ANNUAL WORMWOOD POLLEN artemisia annua pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARTEMISIA ANNUA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-167_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-167 HUMAN PRESCRIPTION DRUG COMMON WORMWOOD POLLEN artemisia absinthium pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ARTEMISIA ABSINTHIUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-168_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-168 HUMAN PRESCRIPTION DRUG MEXICAN TEA POLLEN chenopodium ambrosioides pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CHENOPODIUM AMBROSIOIDES POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-169_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-169 HUMAN PRESCRIPTION DRUG DOCK MIX, SOUR SHEEP SORREL/YELLOW POLLEN rumex acetosella pollen and rumex crispus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN .5; .5 g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-170_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-170 HUMAN PRESCRIPTION DRUG STANDARDIZED RAGWEED MIX, GIANT/SHORT ambrosia trifida pollen and ambrosia artemisiifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN .5; .5 g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-175_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-175 HUMAN PRESCRIPTION DRUG DANDELION POLLEN taraxacum officinale pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TARAXACUM OFFICINALE POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-179_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-179 HUMAN PRESCRIPTION DRUG SUNFLOWER POLLEN helianthus annuus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. HELIANTHUS ANNUUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-181_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-181 HUMAN PRESCRIPTION DRUG ALTERNARIA TENUIS ALTERNATA alternaria alternata INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ALTERNARIA ALTERNATA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-182_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-182 HUMAN PRESCRIPTION DRUG ASPERGILLUS FUMIGATUS aspergillus fumigatus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ASPERGILLUS FUMIGATUS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-183_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-183 HUMAN PRESCRIPTION DRUG ASPERGILLUS GLAUCUS eurotium herbariorum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. EUROTIUM HERBARIORUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-184_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-184 HUMAN PRESCRIPTION DRUG ASPERGILLUS NIGER aspergillus niger var. niger INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-185_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-185 HUMAN PRESCRIPTION DRUG ASPERGILLUS TERREUS aspergillus terreus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ASPERGILLUS TERREUS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-186_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-186 HUMAN PRESCRIPTION DRUG PULLULARIA PULLULANS aureobasidium pullulans var. pullutans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AUREOBASIDIUM PULLULANS VAR. PULLUTANS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-187_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-187 HUMAN PRESCRIPTION DRUG BOTRYTIS CINEREA botrytis cinerea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BOTRYTIS CINEREA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-188_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-188 HUMAN PRESCRIPTION DRUG CANDIDA MONILA ALBICANS candida albicans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CANDIDA ALBICANS 1 g/20mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 54575-189_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-189 HUMAN PRESCRIPTION DRUG CEPHALOSPORIUM ACREMONIUM acremonium strictum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ACREMONIUM STRICTUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-190_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-190 HUMAN PRESCRIPTION DRUG CEPHALOTHECIUM ROSEUM trichothecium roseum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRICHOTHECIUM ROSEUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-191_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-191 HUMAN PRESCRIPTION DRUG CHAETOMIUM GLOBOSUM chaetomium globosum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CHAETOMIUM GLOBOSUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-192_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-192 HUMAN PRESCRIPTION DRUG CLADOSPORIUM FULVUM passalora fulva INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PASSALORA FULVA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-193_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-193 HUMAN PRESCRIPTION DRUG CURVULARIA SPICIFERA cochliobolus spicifer INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. COCHLIOBOLUS SPICIFER 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-194_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-194 HUMAN PRESCRIPTION DRUG EPICOCCUM NIGRUM epicoccum nigrum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. EPICOCCUM NIGRUM 1 g/20mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 54575-195_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-195 HUMAN PRESCRIPTION DRUG EPIDERMOPHYTON FLOCCOSUM epidermophyton floccosum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. EPIDERMOPHYTON FLOCCOSUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-196_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-196 HUMAN PRESCRIPTION DRUG FUSARIUM VASINFECTUM OXYSPORUM fusarium oxysporum vasinfectum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FUSARIUM OXYSPORUM VASINFECTUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-197_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-197 HUMAN PRESCRIPTION DRUG FUSARIUM SOLANI haematonectria haematococca INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. HAEMATONECTRIA HAEMATOCOCCA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-199_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-199 HUMAN PRESCRIPTION DRUG GEOTRICHUM CANDIDUM geotrichum candidum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. GEOTRICHUM CANDIDUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-201_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-201 HUMAN PRESCRIPTION DRUG HELMINTHOSPORIUM SATIVUM cochliobolus sativus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. COCHLIOBOLUS SATIVUS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-202_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-202 HUMAN PRESCRIPTION DRUG HORMODENDRUM CLADOSPORIUM CLADOSPORIOIDES cladosporium cladosporioides INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CLADOSPORIUM CLADOSPORIOIDES 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-208_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-208 HUMAN PRESCRIPTION DRUG MUCOR PLUMBEUS mucor plumbeus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MUCOR PLUMBEUS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-209_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-209 HUMAN PRESCRIPTION DRUG MUCOR RACEMOSUS mucor racemosus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MUCOR RACEMOSUS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-211_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-211 HUMAN PRESCRIPTION DRUG NEUROSPORA SITOPHILA neurospora sitophila INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. NEUROSPORA SITOPHILA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-212_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-212 HUMAN PRESCRIPTION DRUG NIGROSPORA SPHAERICA khuskia oryzae INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. KHUSKIA ORYZAE 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-214_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-214 HUMAN PRESCRIPTION DRUG PENICILLIUM NOTATUM CHRYSOGENUM penicillium chrysogenum var. chrysogenum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-216_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-216 HUMAN PRESCRIPTION DRUG PHOMA DESTRUCTIVA phoma destructiva INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PHOMA DESTRUCTIVA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-217_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-217 HUMAN PRESCRIPTION DRUG RHIZOPUS NIGRICANS rhizopus stolonifer INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. RHIZOPUS STOLONIFER 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-218_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-218 HUMAN PRESCRIPTION DRUG RHODOTORULA MUCILAGINOSA rhodotorula mucilaginosa INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. RHODOTORULA MUCILAGINOSA 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-220_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-220 HUMAN PRESCRIPTION DRUG SPONDYLOCLADIUM ATROVIRENS helminthosporium solani INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. HELMINTHOSPORIUM SOLANI 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-222_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-222 HUMAN PRESCRIPTION DRUG STEMPHYLIUM SARCINIFORME stemphylium sarciniforme INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. STEMPHYLIUM SARCINIFORME 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-223_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-223 HUMAN PRESCRIPTION DRUG TRICHODERMA LIGNORUM trichoderma viride INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRICHODERMA VIRIDE 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-224_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-224 HUMAN PRESCRIPTION DRUG TRICHOPHYTON MENTAGROPHYTES trichophyton mentagrophytes INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRICHOPHYTON MENTAGROPHYTES 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-225_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-225 HUMAN PRESCRIPTION DRUG TRICHOPHYTON RUBRUM trichophyton rubrum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRICHOPHYTON RUBRUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-226_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-226 HUMAN PRESCRIPTION DRUG TRICHOPHYTON TONSURANS trichophyton tonsurans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRICHOPHYTON TONSURANS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-227_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-227 HUMAN PRESCRIPTION DRUG VERTICILLIUM ALBO ATRUM verticillium albo-atrum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. VERTICILLIUM ALBO-ATRUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-228_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-228 HUMAN PRESCRIPTION DRUG RINKEL MOLD MIX A aspergillus fumigatus and botrytis cinerea and chaetomium globosum and epicoccum nigrum and fusarium oxysporum vasinfectum and cochliobolus sativus and neurospora sitophila and mucor plumbeus and phom INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ASPERGILLUS FUMIGATUS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; EPICOCCUM NIGRUM; FUSARIUM OXYSPORUM VASINFECTUM; COCHLIOBOLUS SATIVUS; NEUROSPORA SITOPHILA; MUCOR PLUMBEUS; PHOMA EXIGUA VAR. EXIGUA; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; RHODOTORULA MUCILAGINOSA; SACCHAROMYCES CEREVISIAE; GEOTRICHUM CANDIDUM .066; .066; .066; .066; .066; .067; .067; .067; .067; .067; .067; .067; .067; .067; .067 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-229_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-229 HUMAN PRESCRIPTION DRUG RINKEL MOLD MIX B trichothecium roseum and passalora fulva and cochliobolus spicifer and myrothecium verrucaria and trichophyton schoenleinii and mycogone nigra and neurospora crassa and khuskia oryzae and paecilomyces INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TRICHOTHECIUM ROSEUM; PASSALORA FULVA; COCHLIOBOLUS SPICIFER; MYROTHECIUM VERRUCARIA; TRICHOPHYTON SCHOENLEINII; MYCOGONE NIGRA; NEUROSPORA CRASSA; KHUSKIA ORYZAE; PAECILOMYCES VARIOTII; MICROASCUS BREVICAULIS; HELMINTHOSPORIUM SOLANI; PLEOSPORA TARDA; STREPTOMYCES GRISEUS; TRICHODERMA VIRIDE .071; .071; .071; .071; .071; .071; .071; .071; .072; .072; .072; .072; .072; .072 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Bacterial Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Bacterial Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-230_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-230 HUMAN PRESCRIPTION DRUG RINKEL MOLD MIX C absidia capillata and acrothecium robustum and microsporum audouinii and microsporum canis and apiospora montagnei and phycomyces blakesleeanus and sporotrichum pruinosum and stachybotrys chartarum an INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ABSIDIA CAPILLATA; ACROTHECIUM ROBUSTUM; MICROSPORUM AUDOUINII; MICROSPORUM CANIS; APIOSPORA MONTAGNEI; PHYCOMYCES BLAKESLEEANUS; SPOROTRICHUM PRUINOSUM; STACHYBOTRYS CHARTARUM; SYNCEPHALASTRUM RACEMOSUM; TETRACOCCOSPORIUM PAXIANUM; VERTICILLIUM ALBO-ATRUM; THERMOMYCES LANUGINOSUS; TRICHOSPORON CUTANEUM .076; .077; .077; .077; .077; .077; .077; .077; .077; .077; .077; .077; .077 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-240_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-240 HUMAN PRESCRIPTION DRUG BERMUDA GRASS SMUT ustilago cynodontis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. USTILAGO CYNODONTIS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-241_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-241 HUMAN PRESCRIPTION DRUG CORN SMUT ustilago maydis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. USTILAGO MAYDIS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-243_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-243 HUMAN PRESCRIPTION DRUG JOHNSON GRASS SMUT sporisorium cruentum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SPORISORIUM CRUENTUM 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-248_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-248 HUMAN PRESCRIPTION DRUG WHEAT RUST puccinia graminis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PUCCINIA GRAMINIS 1 g/20mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-257_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-257 HUMAN PRESCRIPTION DRUG COTTON SEED FOR DIAGNOSTIC USE ONLY cotton seed INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. COTTON SEED 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 54575-259_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-259 HUMAN PRESCRIPTION DRUG FLAX SEED FOR DIAGNOSTIC USE ONLY flax seed INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FLAX SEED 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 54575-267_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-267 HUMAN PRESCRIPTION DRUG HOUSE DUST house dust INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. HOUSE DUST 1 g/20mL Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient] N 20181231 54575-270_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-270 HUMAN PRESCRIPTION DRUG KAPOK ceiba pentandra fiber INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CEIBA PENTANDRA FIBER 1 g/20mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-272_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-272 HUMAN PRESCRIPTION DRUG ORRIS ROOT iris germanica var. florentina root INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. IRIS GERMANICA VAR. FLORENTINA ROOT 1 g/20mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Plant Proteins [Chemical/Ingredient] N 20181231 54575-273_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-273 HUMAN PRESCRIPTION DRUG PYRETHRUM tanacetum cinerariifolium flower INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TANACETUM CINERARIIFOLIUM FLOWER 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 54575-278_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-278 HUMAN PRESCRIPTION DRUG SILK bombyx mori fiber INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BOMBYX MORI FIBER 1 g/20mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Silk [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-284_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-284 HUMAN PRESCRIPTION DRUG COTTON LINTERS cotton fiber INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. COTTON FIBER 1 g/20mL Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-288_26d83173-bf33-4460-ac59-b46f052d9787 54575-288 HUMAN PRESCRIPTION DRUG Standardized Cat Hair Felis Domesticus Hair INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19921030 BLA BLA103324 Allergy Laboratories, Inc. FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] N 20181231 54575-289_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-289 HUMAN PRESCRIPTION DRUG CATTLE HAIR AND EPITHELIA bos taurus hair and bos taurus skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BOS TAURUS HAIR; BOS TAURUS SKIN 1; 1 g/20mL; g/20mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-291_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-291 HUMAN PRESCRIPTION DRUG DOG HAIR AND EPITHELIA canis lupus familiaris hair and canis lupus familiaris skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS SKIN 1; 1 g/20mL; g/20mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-293_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-293 HUMAN PRESCRIPTION DRUG CHICKEN FEATHERS gallus gallus feather INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. GALLUS GALLUS FEATHER 1 g/20mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-294_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-294 HUMAN PRESCRIPTION DRUG DUCK FEATHERS anas platyrhynchos feather INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ANAS PLATYRHYNCHOS FEATHER 1 g/20mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] N 20181231 54575-295_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-295 HUMAN PRESCRIPTION DRUG GOOSE FEATHERS anser anser feather INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ANSER ANSER FEATHER 1 g/20mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] N 20181231 54575-296_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-296 HUMAN PRESCRIPTION DRUG FEATHER MIX, CHICKEN/DUCK/GOOSE gallus gallus feather and anas platyrhynchos feather and anser anser feather INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .33; .33; .34 g/20mL; g/20mL; g/20mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] N 20181231 54575-299_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-299 HUMAN PRESCRIPTION DRUG GUINEA PIG HAIR AND EPITHELIA cavia porcellus hair and cavia porcellus skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CAVIA PORCELLUS HAIR; CAVIA PORCELLUS SKIN .5; .5 g/20mL; g/20mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-300_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-300 HUMAN PRESCRIPTION DRUG HAMSTER HAIR AND EPITHELIA mesocricetus auratus skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MESOCRICETUS AURATUS SKIN 1 g/20mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-301_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-301 HUMAN PRESCRIPTION DRUG HOG HAIR AND EPITHELIA sus scrofa hair and sus scrofa skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SUS SCROFA HAIR; SUS SCROFA SKIN 1; 1 g/20mL; g/20mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-302_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-302 HUMAN PRESCRIPTION DRUG HORSE HAIR AND DANDER equus caballus hair and equus caballus skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. EQUUS CABALLUS HAIR; EQUUS CABALLUS SKIN .5; .5 g/20mL; g/20mL Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-305_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-305 HUMAN PRESCRIPTION DRUG MOUSE HAIR AND EPITHELIA mus musculus skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MUS MUSCULUS SKIN 1 g/50mL Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-306_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-306 HUMAN PRESCRIPTION DRUG RABBIT HAIR AND EPITHELIA oryctolagus cuniculus hair and oryctolagus cuniculus skin INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ORYCTOLAGUS CUNICULUS HAIR; ORYCTOLAGUS CUNICULUS SKIN .5; .5 g/20mL; g/20mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-315_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-315 HUMAN PRESCRIPTION DRUG FIRE ANT solenopsis invicta INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SOLENOPSIS INVICTA 1 g/20mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-318_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-318 HUMAN PRESCRIPTION DRUG AMERICAN COCKROACH periplaneta americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PERIPLANETA AMERICANA 1 g/20mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-319_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-319 HUMAN PRESCRIPTION DRUG GERMAN COCKROACH blatella germanica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BLATELLA GERMANICA 1 g/20mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-321_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-321 HUMAN PRESCRIPTION DRUG HOUSEFLY FOR DIAGNOSTIC USE ONLY musca domestica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MUSCA DOMESTICA 1 g/50mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-324_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-324 HUMAN PRESCRIPTION DRUG MOSQUITO FOR DIAGNOSTIC USE ONLY aedes taeniorhynchus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AEDES TAENIORHYNCHUS 1 g/20mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-325_27179a6a-453e-4e7d-8115-f98dcfcf3ec5 54575-325 STANDARDIZED ALLERGENIC STANDARDIZED MITE D FARINAE Dermatophagoides farinae INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19890125 BLA BLA101377 Allergy Laboratories, Inc. DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-326_27179a6a-453e-4e7d-8115-f98dcfcf3ec5 54575-326 STANDARDIZED ALLERGENIC STANDARDIZED MITE D PTERONYSSINUS Dermatophagoides pteronyssinus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19911211 BLA BLA101378 Allergy Laboratories, Inc. DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-333_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-333 HUMAN PRESCRIPTION DRUG ALMOND almond INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ALMOND 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 54575-335_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-335 HUMAN PRESCRIPTION DRUG APPLE apple INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. APPLE 1 g/20mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 54575-336_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-336 HUMAN PRESCRIPTION DRUG APRICOT apricot INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. APRICOT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-338_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-338 HUMAN PRESCRIPTION DRUG AVOCADO avocado INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AVOCADO 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-339_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-339 HUMAN PRESCRIPTION DRUG BANANA banana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BANANA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-340_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-340 HUMAN PRESCRIPTION DRUG BARLEY FOOD barley INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BARLEY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 54575-341_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-341 HUMAN PRESCRIPTION DRUG BASIL basil INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BASIL 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 54575-342_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-342 HUMAN PRESCRIPTION DRUG BLACK BASS largemouth bass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. LARGEMOUTH BASS 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 54575-344_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-344 HUMAN PRESCRIPTION DRUG LIMA BEAN lima bean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. LIMA BEAN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 54575-345_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-345 HUMAN PRESCRIPTION DRUG NAVY BEAN kidney bean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. KIDNEY BEAN 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-346_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-346 HUMAN PRESCRIPTION DRUG PINTO BEAN kidney bean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. KIDNEY BEAN 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-347_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-347 HUMAN PRESCRIPTION DRUG RED KIDNEY BEAN kidney bean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. KIDNEY BEAN 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-348_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-348 HUMAN PRESCRIPTION DRUG SOYBEAN soybean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SOYBEAN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-349_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-349 HUMAN PRESCRIPTION DRUG GREEN STRING BEAN string bean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. STRING BEAN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 54575-350_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-350 HUMAN PRESCRIPTION DRUG BEEF beef INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BEEF 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 54575-353_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-353 HUMAN PRESCRIPTION DRUG BLACKBERRY blackberry INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BLACKBERRY 1 g/20mL N 20181231 54575-354_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-354 HUMAN PRESCRIPTION DRUG BLUEBERRY blue ridge blueberry INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BLUE RIDGE BLUEBERRY 1 g/20mL N 20181231 54575-356_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-356 HUMAN PRESCRIPTION DRUG BROCCOLI broccoli INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BROCCOLI 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-357_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-357 HUMAN PRESCRIPTION DRUG BRUSSEL SPROUTS brussels sprout INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BRUSSELS SPROUT 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-358_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-358 HUMAN PRESCRIPTION DRUG BUCKWHEAT buckwheat INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BUCKWHEAT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 54575-359_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-359 HUMAN PRESCRIPTION DRUG CABBAGE cabbage INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CABBAGE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-360_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-360 HUMAN PRESCRIPTION DRUG CANTALOUPE cantaloupe INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CANTALOUPE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-362_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-362 HUMAN PRESCRIPTION DRUG CARROT carrot INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CARROT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-364_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-364 HUMAN PRESCRIPTION DRUG CASHEW NUT cashew INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CASHEW 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 54575-365_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-365 HUMAN PRESCRIPTION DRUG CATFISH catfish INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CATFISH 1 g/20mL N 20181231 54575-366_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-366 HUMAN PRESCRIPTION DRUG CAULIFLOWER cauliflower INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CAULIFLOWER 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-367_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-367 HUMAN PRESCRIPTION DRUG CELERY celery INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CELERY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-371_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-371 HUMAN PRESCRIPTION DRUG CHERRY FOOD cherry INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CHERRY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-372_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-372 HUMAN PRESCRIPTION DRUG CHICKEN FOOD chicken INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CHICKEN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] N 20181231 54575-374_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-374 HUMAN PRESCRIPTION DRUG CINNAMON cinnamon INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CINNAMON 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-375_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-375 HUMAN PRESCRIPTION DRUG CLAM quahog INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUAHOG 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 54575-377_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-377 HUMAN PRESCRIPTION DRUG CACAO BEAN cocoa INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. COCOA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 54575-378_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-378 HUMAN PRESCRIPTION DRUG COCONUT coconut INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. COCONUT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-379_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-379 HUMAN PRESCRIPTION DRUG CODFISH cod INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. COD 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 54575-380_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-380 HUMAN PRESCRIPTION DRUG COFFEE FOR DIAGNOSTIC USE ONLY coffee bean INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. COFFEE BEAN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 54575-381_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-381 HUMAN PRESCRIPTION DRUG CORN FOOD corn INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CORN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 54575-382_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-382 HUMAN PRESCRIPTION DRUG CRAB MEAT blue crab INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BLUE CRAB 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 54575-383_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-383 HUMAN PRESCRIPTION DRUG CRANBERRY cranberry INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CRANBERRY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-385_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-385 HUMAN PRESCRIPTION DRUG CUCUMBER cucumber INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CUCUMBER 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-387_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-387 HUMAN PRESCRIPTION DRUG DATE date INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. DATE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-388_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-388 HUMAN PRESCRIPTION DRUG DILL SEED dill INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. DILL 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 54575-389_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-389 HUMAN PRESCRIPTION DRUG EGG WHITE egg white INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. EGG WHITE 1 g/20mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] N 20181231 54575-390_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-390 HUMAN PRESCRIPTION DRUG WHOLE EGG egg INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. EGG 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] N 20181231 54575-391_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-391 HUMAN PRESCRIPTION DRUG EGG YOLK egg yolk INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. EGG YOLK 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] N 20181231 54575-394_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-394 HUMAN PRESCRIPTION DRUG FLOUNDER flounder INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. FLOUNDER 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 54575-395_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-395 HUMAN PRESCRIPTION DRUG GARLIC garlic INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. GARLIC 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 54575-397_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-397 HUMAN PRESCRIPTION DRUG GINGER ginger INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. GINGER 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 54575-398_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-398 HUMAN PRESCRIPTION DRUG GRAPE concord grape INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CONCORD GRAPE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-399_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-399 HUMAN PRESCRIPTION DRUG GRAPEFRUIT grapefruit INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. GRAPEFRUIT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-400_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-400 HUMAN PRESCRIPTION DRUG HADDOCK haddock INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. HADDOCK 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 54575-401_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-401 HUMAN PRESCRIPTION DRUG HALIBUT pacific halibut INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PACIFIC HALIBUT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 54575-405_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-405 HUMAN PRESCRIPTION DRUG HORSERADISH horseradish INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. HORSERADISH 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 54575-406_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-406 HUMAN PRESCRIPTION DRUG LEMON lemon INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. LEMON 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-407_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-407 HUMAN PRESCRIPTION DRUG LETTUCE lettuce INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. LETTUCE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-408_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-408 HUMAN PRESCRIPTION DRUG LIME lime, citrus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. LIME (CITRUS) 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-410_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-410 HUMAN PRESCRIPTION DRUG BARLEY MALT barley malt INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BARLEY MALT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 54575-412_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-412 HUMAN PRESCRIPTION DRUG COW MILK cow milk INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. COW MILK 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] N 20181231 54575-414_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-414 HUMAN PRESCRIPTION DRUG MUSHROOM FOOD cultivated mushroom INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. CULTIVATED MUSHROOM 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20181231 54575-415_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-415 HUMAN PRESCRIPTION DRUG MUSTARD SEED mustard seed INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. MUSTARD SEED 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 54575-418_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-418 HUMAN PRESCRIPTION DRUG OATS FOOD oat INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. OAT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 54575-420_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-420 HUMAN PRESCRIPTION DRUG GREEN OLIVE green olive INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. GREEN OLIVE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-422_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-422 HUMAN PRESCRIPTION DRUG ONION onion INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. ONION 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-423_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-423 HUMAN PRESCRIPTION DRUG ORANGE FOOD orange INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ORANGE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-424_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-424 HUMAN PRESCRIPTION DRUG OREGANO oregano INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. OREGANO 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 54575-426_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-426 HUMAN PRESCRIPTION DRUG PAPAYA papaya INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PAPAYA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-428_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-428 HUMAN PRESCRIPTION DRUG PARSLEY parsley INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PARSLEY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-430_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-430 HUMAN PRESCRIPTION DRUG BLACKEYED PEA black-eyed pea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BLACK-EYED PEA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] N 20181231 54575-431_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-431 HUMAN PRESCRIPTION DRUG GREEN PEA pea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PEA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-432_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-432 HUMAN PRESCRIPTION DRUG PEACH peach INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PEACH 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-433_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-433 HUMAN PRESCRIPTION DRUG PEANUT FOOD peanut INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PEANUT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 54575-434_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-434 HUMAN PRESCRIPTION DRUG PEAR pear INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PEAR 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-435_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-435 HUMAN PRESCRIPTION DRUG PECAN FOOD pecan INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PECAN 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 54575-436_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-436 HUMAN PRESCRIPTION DRUG BLACK PEPPER black pepper INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BLACK PEPPER 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-437_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-437 HUMAN PRESCRIPTION DRUG GREEN PEPPER green bell pepper INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. GREEN BELL PEPPER 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-438_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-438 HUMAN PRESCRIPTION DRUG PERCH perch INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PERCH 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 54575-439_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-439 HUMAN PRESCRIPTION DRUG PIMENTO red bell pepper INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. RED BELL PEPPER 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-440_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-440 HUMAN PRESCRIPTION DRUG PINEAPPLE pineapple INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PINEAPPLE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-442_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-442 HUMAN PRESCRIPTION DRUG POPPY SEED poppy seed INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. POPPY SEED 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 54575-443_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-443 HUMAN PRESCRIPTION DRUG PORK pork INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PORK 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 54575-444_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-444 HUMAN PRESCRIPTION DRUG SWEET POTATO sweet potato INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SWEET POTATO 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-445_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-445 HUMAN PRESCRIPTION DRUG WHITE POTATO potato INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. POTATO 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-449_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-449 HUMAN PRESCRIPTION DRUG RADISH radish INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. RADISH 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-451_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-451 HUMAN PRESCRIPTION DRUG RHUBARB rhubarb INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. RHUBARB 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 54575-452_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-452 HUMAN PRESCRIPTION DRUG RICE FOOD rice INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. RICE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 54575-453_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-453 HUMAN PRESCRIPTION DRUG RYE FOOD rye INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. RYE 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 54575-454_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-454 HUMAN PRESCRIPTION DRUG SAGE FOOD sage INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SAGE 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 54575-455_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-455 HUMAN PRESCRIPTION DRUG PACIFIC SALMON pink salmon INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PINK SALMON 1 g/20mL N 20181231 54575-456_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-456 HUMAN PRESCRIPTION DRUG SCALLOP scallop INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SCALLOP 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 54575-457_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-457 HUMAN PRESCRIPTION DRUG SESAME SEED sesame seed INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SESAME SEED 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 54575-458_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-458 HUMAN PRESCRIPTION DRUG SHRIMP shrimp INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SHRIMP 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 54575-459_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-459 HUMAN PRESCRIPTION DRUG SPEARMINT spearmint INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SPEARMINT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] N 20181231 54575-460_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-460 HUMAN PRESCRIPTION DRUG SPINACH spinach INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SPINACH 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-461_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-461 HUMAN PRESCRIPTION DRUG YELLOW SQUASH squash INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SQUASH 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-462_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-462 HUMAN PRESCRIPTION DRUG STRAWBERRY strawberry INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. STRAWBERRY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-463_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-463 HUMAN PRESCRIPTION DRUG SUNFLOWER SEED sunflower seed INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. SUNFLOWER SEED 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 54575-465_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-465 HUMAN PRESCRIPTION DRUG THYME thyme INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. THYME 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-466_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-466 HUMAN PRESCRIPTION DRUG TOMATO tomato INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. TOMATO 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 54575-467_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-467 HUMAN PRESCRIPTION DRUG LAKE TROUT trout INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. TROUT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 54575-468_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-468 HUMAN PRESCRIPTION DRUG TUNA tuna INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. TUNA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 54575-469_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-469 HUMAN PRESCRIPTION DRUG TURKEY FOOD turkey INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. TURKEY 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] N 20181231 54575-471_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-471 HUMAN PRESCRIPTION DRUG VANILLA vanilla INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. VANILLA 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Food Additives [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-472_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-472 HUMAN PRESCRIPTION DRUG BLACK WALNUT FOOD black walnut INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. BLACK WALNUT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 54575-473_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-473 HUMAN PRESCRIPTION DRUG ENGLISH WALNUT FOOD english walnut INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. ENGLISH WALNUT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 54575-474_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-474 HUMAN PRESCRIPTION DRUG WATERMELON watermelon INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. WATERMELON 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 54575-476_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-476 HUMAN PRESCRIPTION DRUG WHOLE WHEAT FOOD wheat INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. WHEAT 1 g/20mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 54575-486_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-486 HUMAN PRESCRIPTION DRUG PEPPERMINT peppermint INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19720829 BLA BLA102192 Allergy Laboratories, Inc. PEPPERMINT 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 54575-901_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-901 HUMAN PRESCRIPTION DRUG ACACIA POLLEN acacia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ACACIA 1 g/20mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-902_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-902 HUMAN PRESCRIPTION DRUG RED ALDER POLLEN alnus rubra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ALNUS RUBRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-903_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-903 HUMAN PRESCRIPTION DRUG SMOOTH ALDER POLLEN alnus incana subsp. rugosa pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ALNUS INCANA SUBSP. RUGOSA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-904_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-904 HUMAN PRESCRIPTION DRUG ARIZONA ASH POLLEN fraxinus velutina pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FRAXINUS VELUTINA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-905_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-905 HUMAN PRESCRIPTION DRUG GREEN RED ASH POLLEN fraxinus pennsylvanica pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FRAXINUS PENNSYLVANICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-906_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-906 HUMAN PRESCRIPTION DRUG WHITE ASH POLLEN fraxinus americana pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FRAXINUS AMERICANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-907_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-907 HUMAN PRESCRIPTION DRUG ASH MIX, GREEN/WHITE POLLEN fraxinus americana pollen and fraxinus pennsylvanica pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN .5; .5 g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-908_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-908 HUMAN PRESCRIPTION DRUG QUAKING ASPEN POLLEN populus tremuloides pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POPULUS TREMULOIDES POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-909_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-909 HUMAN PRESCRIPTION DRUG BAYBERRY POLLEN morella cerifera pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MORELLA CERIFERA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-910_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-910 HUMAN PRESCRIPTION DRUG AMERICAN BEECH POLLEN fagus grandifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. FAGUS GRANDIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-912_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-912 HUMAN PRESCRIPTION DRUG RIVER BIRCH POLLEN betula nigra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BETULA NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-913_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-913 HUMAN PRESCRIPTION DRUG BIRCH MIX, RIVER/PAPER/SWEET/WHITE POLLEN betula nigra pollen and betula papyrifera pollen and betula lenta pollen and betula populifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA LENTA POLLEN; BETULA POPULIFOLIA POLLEN .25; .25; .25; .25 g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-914_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-914 HUMAN PRESCRIPTION DRUG BOX ELDER POLLEN acer negundo pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ACER NEGUNDO POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-915_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-915 HUMAN PRESCRIPTION DRUG MOUNTAIN CEDAR POLLEN juniperus ashei pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. JUNIPERUS ASHEI POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-916_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-916 HUMAN PRESCRIPTION DRUG PINCHOT CEDAR POLLEN juniperus pinchotii pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. JUNIPERUS PINCHOTII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-917_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-917 HUMAN PRESCRIPTION DRUG RED CEDAR POLLEN juniperus virginiana pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. JUNIPERUS VIRGINIANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-919_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-919 HUMAN PRESCRIPTION DRUG EASTERN COTTONWOOD POLLEN populus deltoides pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POPULUS DELTOIDES POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-920_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-920 HUMAN PRESCRIPTION DRUG WESTERN COTTONWOOD POLLEN populus deltoides subsp. monilifera pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-921_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-921 HUMAN PRESCRIPTION DRUG COTTONWOOD MIX, EASTERN/WESTERN POLLEN populus deltoides subsp. monilifera pollen and populus deltoides pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS DELTOIDES POLLEN .5; .5 g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-922_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-922 HUMAN PRESCRIPTION DRUG ARIZONA CYPRESS POLLEN cupressus arizonica pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CUPRESSUS ARIZONICA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-923_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-923 HUMAN PRESCRIPTION DRUG BALD CYPRESS POLLEN taxodium distichum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. TAXODIUM DISTICHUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-924_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-924 HUMAN PRESCRIPTION DRUG AMERICAN ELM POLLEN ulmus americana pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ULMUS AMERICANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-925_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-925 HUMAN PRESCRIPTION DRUG CEDAR FALL BLOOMING ELM POLLEN ulmus crassifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ULMUS CRASSIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-926_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-926 HUMAN PRESCRIPTION DRUG CHINESE SIBERIAN ELM POLLEN ulmus pumila pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ULMUS PUMILA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-928_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-928 HUMAN PRESCRIPTION DRUG ELM MIX, AMERICAN/CHINESE/SLIPPERY POLLEN ulmus pumila pollen and ulmus americana pollen and ulmus rubra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ULMUS PUMILA POLLEN; ULMUS AMERICANA POLLEN; ULMUS RUBRA POLLEN .33; .33; .34 g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-929_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-929 HUMAN PRESCRIPTION DRUG EUCALYPTUS BLUE GUM POLLEN eucalyptus globulus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. EUCALYPTUS GLOBULUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-930_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-930 HUMAN PRESCRIPTION DRUG DOUGLAS FIR POLLEN pseudotsuga menziesii pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PSEUDOTSUGA MENZIESII POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-932_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-932 HUMAN PRESCRIPTION DRUG SWEETGUM POLLEN liquidambar styraciflua pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. LIQUIDAMBAR STYRACIFLUA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-933_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-933 HUMAN PRESCRIPTION DRUG HACKBERRY POLLEN celtis occidentalis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CELTIS OCCIDENTALIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-935_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-935 HUMAN PRESCRIPTION DRUG SHAGBARK HICKORY POLLEN carya ovata pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CARYA OVATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-936_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-936 HUMAN PRESCRIPTION DRUG WHITE HICKORY POLLEN carya tomentosa pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CARYA TOMENTOSA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-937_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-937 HUMAN PRESCRIPTION DRUG HICKORY MIX, PIGNUT/SHAGBARK/SHELLBARK/WHITE POLLEN carya tomentosa pollen and carya laciniosa pollen and carya ovata pollen and carya glabra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CARYA TOMENTOSA POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CARYA GLABRA POLLEN .25; .25; .25; .25 g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-938_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-938 HUMAN PRESCRIPTION DRUG ONE SEED JUNIPER POLLEN juniperus monosperma pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. JUNIPERUS MONOSPERMA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-939_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-939 HUMAN PRESCRIPTION DRUG ROCKY MOUNTAIN JUNIPER POLLEN juniperus scopulorum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. JUNIPERUS SCOPULORUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-940_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-940 HUMAN PRESCRIPTION DRUG WHITE GRAY BIRCH POLLEN betula populifolia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BETULA POPULIFOLIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-941_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-941 HUMAN PRESCRIPTION DRUG SUGAR HARD MAPLE POLLEN acer saccharum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ACER SACCHARUM POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-943_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-943 HUMAN PRESCRIPTION DRUG MAPLE MIX, RED/SILVER/SUGAR POLLEN acer saccharum pollen and acer saccharinum pollen and acer rubrum pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ACER SACCHARUM POLLEN; ACER SACCHARINUM POLLEN; ACER RUBRUM POLLEN .33; .33; .34 g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-944_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-944 HUMAN PRESCRIPTION DRUG MESQUITE POLLEN prosopis juliflora pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PROSOPIS JULIFLORA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-945_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-945 HUMAN PRESCRIPTION DRUG PAPER MULBERRY POLLEN broussonetia papyrifera pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. BROUSSONETIA PAPYRIFERA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-946_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-946 HUMAN PRESCRIPTION DRUG RED MULBERRY POLLEN morus rubra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MORUS RUBRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-947_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-947 HUMAN PRESCRIPTION DRUG WHITE MULBERRY POLLEN morus alba pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MORUS ALBA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-948_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-948 HUMAN PRESCRIPTION DRUG BLACK OAK POLLEN quercus velutina pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS VELUTINA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-949_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-949 HUMAN PRESCRIPTION DRUG BLACKJACK OAK POLLEN quercus nigra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-950_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-950 HUMAN PRESCRIPTION DRUG BUR OAK POLLEN quercus macrocarpa pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS MACROCARPA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-951_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-951 HUMAN PRESCRIPTION DRUG LIVE OAK POLLEN quercus virginiana pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS VIRGINIANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-952_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-952 HUMAN PRESCRIPTION DRUG 2-OAK MIX, RED/WHITE POLLEN quercus rubra pollen and quercus alba pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN .5; .5 g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-953_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-953 HUMAN PRESCRIPTION DRUG 3-OAK MIX, BLACK/BLACKJACK/POST POLLEN quercus velutina pollen and quercus nigra pollen and quercus stellata pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS VELUTINA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS STELLATA POLLEN .33; .33; .34 g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-954_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-954 HUMAN PRESCRIPTION DRUG 5-OAK MIX, BLACKJACK/BUR/POST/RED/WHITE POLLEN quercus nigra pollen and quercus macrocarpa pollen and quercus stellata pollen and quercus rubra pollen and quercus alba pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS NIGRA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN .2; .2; .2; .2; .2 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-955_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-955 HUMAN PRESCRIPTION DRUG POST OAK POLLEN quercus stellata pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS STELLATA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-956_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-956 HUMAN PRESCRIPTION DRUG QUEEN PALM POLLEN syagrus romanzoffiana pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SYAGRUS ROMANZOFFIANA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-957_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-957 HUMAN PRESCRIPTION DRUG EUROPEAN OLIVE POLLEN olea europaea pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. OLEA EUROPAEA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-958_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-958 HUMAN PRESCRIPTION DRUG OSAGE ORANGE VAR BOIS DARC POLLEN maclura pomifera pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. MACLURA POMIFERA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-959_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-959 HUMAN PRESCRIPTION DRUG DATE PALM POLLEN phoenix dactylifera pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PHOENIX DACTYLIFERA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-960_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-960 HUMAN PRESCRIPTION DRUG PECAN POLLEN carya illinoinensis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. CARYA ILLINOINENSIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-962_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-962 HUMAN PRESCRIPTION DRUG WHITE PINE POLLEN pinus strobus pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PINUS STROBUS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-963_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-963 HUMAN PRESCRIPTION DRUG 4-PINE MIX, AUSTRIAN/LOBLOLLY/SCOTCH/WHITE POLLEN pinus strobus pollen and pinus sylvestris pollen and pinus taeda pollen and pinus nigra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PINUS NIGRA POLLEN .25; .25; .25; .25 g/20mL; g/20mL; g/20mL; g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-964_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-964 HUMAN PRESCRIPTION DRUG LOMBARDY POPLAR POLLEN populus nigra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POPULUS NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-965_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-965 HUMAN PRESCRIPTION DRUG WHITE POPLAR POLLEN populus alba pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. POPULUS ALBA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-966_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-966 HUMAN PRESCRIPTION DRUG PRIVET POLLEN ligustrum vulgare pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. LIGUSTRUM VULGARE POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-967_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-967 HUMAN PRESCRIPTION DRUG BLUE SPRUCE POLLEN picea pungens pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PICEA PUNGENS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-968_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-968 HUMAN PRESCRIPTION DRUG UPLAND SUMAC POLLEN rhus glabra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. RHUS GLABRA POLLEN 1 g/20mL N 20181231 54575-969_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-969 HUMAN PRESCRIPTION DRUG SYCAMORE POLLEN platanus occidentalis pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. PLATANUS OCCIDENTALIS POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-970_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-970 HUMAN PRESCRIPTION DRUG TREE OF HEAVEN POLLEN ailanthus altissima pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. AILANTHUS ALTISSIMA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-971_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-971 HUMAN PRESCRIPTION DRUG BLACK WALNUT POLLEN juglans nigra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. JUGLANS NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-972_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-972 HUMAN PRESCRIPTION DRUG BLACK WILLOW POLLEN salix nigra pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SALIX NIGRA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-973_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-973 HUMAN PRESCRIPTION DRUG PUSSY WILLOW POLLEN salix discolor pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. SALIX DISCOLOR POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-974_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-974 HUMAN PRESCRIPTION DRUG BLACK LOCUST POLLEN robinia pseudoacacia pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. ROBINIA PSEUDOACACIA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54575-978_dbe7bebd-e445-4e59-8302-e706b795fbde 54575-978 HUMAN PRESCRIPTION DRUG WHITE OAK POLLEN quercus alba pollen INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19671207 BLA BLA101376 Allergy Laboratories, Inc. QUERCUS ALBA POLLEN 1 g/20mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 54576-1001_e8fe11ac-688d-4443-bcfb-df8122a8d5f4 54576-1001 HUMAN OTC DRUG Roota Re F for men PANTHENOL SHAMPOO TOPICAL 20121231 UNAPPROVED DRUG OTHER Raphabio Inc PANTHENOL 1.2 mg/240mL E 20171231 54576-2001_63abf12b-aa96-4128-9098-5485a3f03532 54576-2001 HUMAN OTC DRUG Roota Re V for women PANTHENOL SHAMPOO TOPICAL 20121231 UNAPPROVED DRUG OTHER Raphabio Inc PANTHENOL 1.2 mg/240mL E 20171231 54576-3001_8262bbb8-27c7-4ee5-ab48-289af41da4a0 54576-3001 HUMAN OTC DRUG Roota Re F Tonic PANTHENOL LIQUID TOPICAL 20121231 UNAPPROVED DRUG OTHER Raphabio Inc PANTHENOL .5 mg/100mL E 20171231 54576-4001_85a5ce96-0229-4cff-928e-c422fbb37e0b 54576-4001 HUMAN OTC DRUG Roota Re V Tonic PANTHENOL LIQUID TOPICAL 20121231 UNAPPROVED DRUG OTHER Raphabio Inc PANTHENOL .5 mg/100mL E 20171231 54582-0001_893fc550-ce3d-4146-8ac6-1c3370f9c576 54582-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS Lowry Drug Company Inc. OXYGEN 99 L/100L E 20171231 54591-001_36595864-eed4-4121-acf3-4cc919708f45 54591-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930810 UNAPPROVED MEDICAL GAS Speedy Inc. OXYGEN 99 L/100L E 20171231 54593-001_7c0997fb-96ea-49bc-a5a1-7708f5d61904 54593-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140410 UNAPPROVED MEDICAL GAS CHV Home Medical Equipment Company, LLC OXYGEN 99 L/100L E 20171231 54595-001_29291edb-1e37-654b-e054-00144ff8d46c 54595-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19940701 UNAPPROVED MEDICAL GAS Sparrow Medical Supply L.L.C. OXYGEN 99 mL/L E 20171231 54602-011_0db34654-d5f1-468f-b422-c22ccbef396f 54602-011 HUMAN OTC DRUG At One With Nature Menthol 1% GEL, DENTIFRICE TOPICAL 20140918 OTC MONOGRAPH NOT FINAL part348 BIOCARE LABS INC. MENTHOL 10 mg/g E 20171231 54602-758_3398bb40-df14-494e-9e1f-619629b94979 54602-758 HUMAN OTC DRUG AT ONE WITH NATURE DRY AND ITCHY SCALP PYRITHIONE ZINC SHAMPOO TOPICAL 20090120 OTC MONOGRAPH FINAL part358H BIOCARE LABS INC. PYRITHIONE ZINC 10 mg/mL E 20171231 54616-001_3dc4cafe-10de-489f-8d54-94538a3678b1 54616-001 HUMAN OTC DRUG BALANCE Bryonia, Ignatia, Nux Vom, Phos, Sepia SPRAY SUBLINGUAL 20130221 UNAPPROVED HOMEOPATHIC BDMP, LLC BRYONIA ALBA ROOT; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30 [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL E 20171231 54619-0001_916626e8-e282-4989-b834-4ecea42604a9 54619-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20121212 UNAPPROVED MEDICAL GAS Red Ball Medical Supply OXYGEN 99 L/100L E 20171231 54622-015_7aa42653-1c39-48f9-abf3-14bf3ab6e37d 54622-015 HUMAN OTC DRUG Ethyl Alcohol Ethyl Alcohol SOLUTION TOPICAL 20170703 OTC MONOGRAPH NOT FINAL part333A Georgia Pacific Consumer Products ALCOHOL .67 mL/mL N 20181231 54622-054_3a59e402-fce2-526b-e054-00144ff88e88 54622-054 HUMAN OTC DRUG enMotion Antimicrobial Foam TRICLOSAN SOAP TOPICAL 20160812 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP TRICLOSAN 4.5 mg/mL N 20181231 54622-120_639eb6c6-ff73-0291-e053-2a91aa0a3fb3 54622-120 HUMAN OTC DRUG EnMotion Foam Hand Sanitizer Ethyl alcohol LIQUID TOPICAL 20180125 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products ALCOHOL 70 mL/100mL N 20191231 54622-146_cac5d5d5-ae52-4e9b-9fef-85bb2584bba1 54622-146 HUMAN OTC DRUG enMotion Foam Benzalkonium chloride SOLUTION TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333A Georgia Pacific Consumer Products BENZALKONIUM CHLORIDE .998 g/mL N 20181231 54622-148_5321bfd1-980e-4eff-aaa3-88538ef8c5a6 54622-148 HUMAN OTC DRUG Hand Sanitizer Benzalkonium Chloride 0.1%w/w LIQUID TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part333A Georgia Pacific Consumer Products BENZALKONIUM CHLORIDE 1 mg/mL N 20191231 54622-300_25767c81-7ab0-405f-9fc0-c2d48ab2c39d 54622-300 HUMAN OTC DRUG EnMotion Foam Hand Sanitizer With Moisturizers Ethyl alcohol LIQUID TOPICAL 20160909 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products ALCOHOL .7 mL/100mL N 20181231 54622-301_10f863b9-961d-46be-9f90-edc2cda38dba 54622-301 HUMAN OTC DRUG enMotion High Frequency Use Foam Hand Sanitizer Ethyl alcohol LIQUID TOPICAL 20160909 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products ALCOHOL .7 mL/100mL N 20181231 54622-302_213d8a7a-e5e1-48c8-92e9-bcec33473610 54622-302 HUMAN OTC DRUG Pacific Garden E3 Rated Foam Hand Sanitizer Ethyl alcohol LIQUID TOPICAL 20161024 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products ALCOHOL .7 mL/100mL N 20181231 54622-303_1b5c6979-b360-4420-b785-01e87ec9ce74 54622-303 HUMAN OTC DRUG enMotion Antimicrobial Foam with Moisturizers Benzalkonium chloride SOLUTION TOPICAL 20170320 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products BENZALKONIUM CHLORIDE .26 g/100mL N 20181231 54622-304_0be7e449-04bd-44d4-bab9-79c7454c80d1 54622-304 HUMAN OTC DRUG enMotion Antimicrobial Foam with Moisturizers Tranquil Aloe, Green Triclosan-Free Benzalkonium Chloride SOLUTION TOPICAL 20170320 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products BENZALKONIUM CHLORIDE .26 g/100mL N 20181231 54622-305_5f8a61e6-584e-4085-b8ff-779d6b108bd2 54622-305 HUMAN OTC DRUG Pacific Garden Antimicrobial Foam Fragrance Free, Dye Free, Triclosan-Free Benzalkonium Chloride SOLUTION TOPICAL 20170317 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products BENZALKONIUM CHLORIDE .26 g/100mL N 20181231 54622-306_17ba0184-d35b-4f8b-bfaf-01a3855a3d19 54622-306 HUMAN OTC DRUG Pacific Garden Antimicrobial Foam Pacific Citrus, Mandarin, Triclosan-Free Benzalkonium Chloride SOLUTION TOPICAL 20170317 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products BENZALKONIUM CHLORIDE .26 g/100mL N 20181231 54622-307_43df3cb5-60d8-4418-83f4-3ce9f136a096 54622-307 HUMAN OTC DRUG enMotion E3 Rated Gel Hand Sanitizer With Moisturizers Fragrance Free, Dye Free Ethyl alcohol LIQUID TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products ALCOHOL .67 mL/100mL N 20181231 54622-308_1b74c6ff-fc4f-4146-a828-993a1f2cc577 54622-308 HUMAN OTC DRUG Pacific Blue Select Gel Hand Sanitizer Fragrance and Dye Free Ethyl alcohol LIQUID TOPICAL 20171011 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products ALCOHOL .67 mL/100mL N 20181231 54622-309_e418cd4b-5e18-4565-8859-4f530e8a46d2 54622-309 HUMAN OTC DRUG Pacific Blue Select Gel Hand Sanitizer with Moisturizers Ethyl alcohol LIQUID TOPICAL 20180111 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products ALCOHOL .67 mL/mL N 20191231 54622-389_5f3684a8-f2a0-4d16-833d-cc2a69a47b38 54622-389 HUMAN OTC DRUG enMotion Antimicrobial Healthcare Personnel Handwash Fragrance Free CHLOROXYLENOL LIQUID TOPICAL 20130821 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP CHLOROXYLENOL 10 mg/mL N 20181231 54622-486_f2d729d6-90e4-45f6-b8f1-b977f648ae01 54622-486 HUMAN OTC DRUG enMotion Foam High Frequency Use Ethyl Alcohol SOLUTION TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333A Georgia Pacific Consumer Products ALCOHOL .7 mL/mL N 20181231 54622-520_63a08abb-1fad-3cac-e053-2991aa0abd08 54622-520 HUMAN OTC DRUG Georgia-Pacific Alcohol Hand Sanitizer Alcohol SOAP TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP ALCOHOL .67 mL/mL N 20191231 54622-572_ad091b15-2542-489e-8fe4-349bc79c449e 54622-572 HUMAN OTC DRUG Pacific Blue Ultra Benzalkonium Chloride SOAP TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part333A Georgia Pacific Consumer Products BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 54622-686_639f9d57-f249-708a-e053-2a91aa0a6962 54622-686 HUMAN OTC DRUG enMotion Hand Sanitizer with Moisturizers, Fragrance Free, Dye Free Alcohol GEL TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP ALCOHOL .5634 g/mL N 20191231 54622-687_63a08b6c-fba9-3139-e053-2a91aa0a8bc7 54622-687 HUMAN OTC DRUG Pacific Garden Antimicrobial, Fragrance Free, Dye Free Triclosan SOAP TOPICAL 20091002 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP TRICLOSAN 4.5 mg/mL N 20191231 54622-688_639e932c-52df-d2b3-e053-2a91aa0a1ce9 54622-688 HUMAN OTC DRUG Pacific Garden Antimicrobial, Pacific Citrus, Mandarin Triclosan SOAP TOPICAL 20091002 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP TRICLOSAN 4.5 mg/mL N 20191231 54622-689_639fd681-3b11-1a55-e053-2991aa0ae7d3 54622-689 HUMAN OTC DRUG Pacific Garden Foam Hand Sanitizer, Fragrance Free, Dye Free Alcohol SOAP TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP ALCOHOL .7 mL/mL N 20191231 54622-697_639ecbfc-5060-680b-e053-2991aa0adb10 54622-697 HUMAN OTC DRUG enMotion Antimicrobial with Moisturizers, Fragrance free, dye free Triclosan SOAP TOPICAL 20091002 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP TRICLOSAN 4.5 mg/mL N 20191231 54622-698_63a047ae-66ce-bd1d-e053-2a91aa0a9c36 54622-698 HUMAN OTC DRUG enMotion Antimicrobial with Moisturizers, Tranquil Aloe, Green Triclosan SOAP TOPICAL 20091002 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP TRICLOSAN 4.5 mg/mL N 20191231 54622-699_639ef98a-dad8-6b14-e053-2a91aa0a6f6b 54622-699 HUMAN OTC DRUG enMotion Foam Hand Sanitizer w-Moisturizers, Fragrance Free Alcohol SOAP TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333E Georgia-Pacific Consumer Products LP ALCOHOL .7 mL/mL N 20191231 54622-700_61c0ba7f-c08f-4471-a395-7e5fa5cf3103 54622-700 HUMAN OTC DRUG enMotion Antimicrobial with Moisturizers, Tranquil Aloe Benzalkonium chloride SOAP TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333A Georgia Pacific Consumer Products BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 54622-701_b6dd649c-7b1a-4ca2-a432-4a8c8f3f9277 54622-701 HUMAN OTC DRUG Pacific Blue Ultra Foaming Fragrance Free Ethyl Alcohol SOLUTION TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333A Georgia Pacific Consumer Products ALCOHOL 70 mg/mL N 20181231 54622-703_be611dee-17e1-4f07-b49f-cbdab930aaf3 54622-703 HUMAN OTC DRUG enMotion Antimicrobial with Moisturizers, Fragrance Free Benzalkonium chloride SOAP TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333A Georgia Pacific Consumer Products BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 54622-708_f804b0ac-86f9-4322-8764-396f5f3cc570 54622-708 HUMAN OTC DRUG enMotion Foam with Moisturizers fragrance free Ethyl Alcohol SOLUTION TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333A Georgia Pacific Consumer Products ALCOHOL 70 mg/mL N 20181231 54622-712_f872d6bd-693d-4327-a9b8-01844259b14a 54622-712 HUMAN OTC DRUG Pacific Blue Ultra Antimicrobial Pacific Citrus Benzalkonium chloride SOAP TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part333A Georgia Pacific Consumer Products BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 54629-600_eef28aa9-3750-4db6-a059-881f7400b040 54629-600 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000501 OTC MONOGRAPH NOT FINAL part334 National Vitamin Company DOCUSATE SODIUM 100 mg/1 N 20181231 54629-601_0c66642c-82cb-42cd-82bb-5f95852cc5d1 54629-601 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000501 OTC MONOGRAPH NOT FINAL part334 National Vitamin Company DOCUSATE SODIUM 250 mg/1 N 20181231 54629-640_52139708-8a21-4fc5-b375-c6f9064cce22 54629-640 HUMAN OTC DRUG Docusate Calcium 240 mg sodium free Docusate Calcium CAPSULE, LIQUID FILLED ORAL 20160201 OTC MONOGRAPH NOT FINAL part334 National Vitamin Company DOCUSATE CALCIUM 240 mg/1 N 20181231 54632-001_484492a6-2cca-46ad-af4e-b0a13ccc73f2 54632-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20121115 NDA NDA206023 U.S. Oxygen and Supply, LLC OXYGEN 99 L/100L E 20171231 54632-002_6d8cbe38-ad58-4d0d-9246-007452afb943 54632-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20121115 NDA NDA206024 U.S. Oxygen and Supply, LLC NITROGEN 99 L/100L E 20171231 54632-003_470e5257-35dd-4b34-b705-fe1cee98ddac 54632-003 HUMAN PRESCRIPTION DRUG AIR, COMPRESSED OXYGEN GAS RESPIRATORY (INHALATION) 20121115 NDA NDA206023 U.S. Oxygen and Supply, LLC OXYGEN 21 L/100L E 20171231 54632-004_25c61dad-4053-4391-a790-a3bd4c8cf119 54632-004 HUMAN PRESCRIPTION DRUG CARBON DIOXIDE CARBON DIOXIDE GAS RESPIRATORY (INHALATION) 20121115 NDA NDA206025 U.S. Oxygen and Supply, LLC CARBON DIOXIDE 99 L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 54633-014_60ba6f8a-861c-d4f6-e053-2991aa0a4a71 54633-014 HUMAN OTC DRUG Gentian Violet 2% gentian violet 2% SOLUTION TOPICAL 20141014 OTC MONOGRAPH NOT FINAL part333A The Podiatree Company GENTIAN VIOLET 2 g/100mL N 20181231 54633-017_60cb962b-0e2d-105a-e053-2a91aa0a040e 54633-017 HUMAN OTC DRUG Fortinia OF clotrimazole 1% SOLUTION TOPICAL 20170705 OTC MONOGRAPH FINAL part333C The Podiatree Company CLOTRIMAZOLE 1 g/100mL N 20181231 54633-101_97b770e7-9125-4db8-89ee-f1b66e01a755 54633-101 HUMAN OTC DRUG Aarica Aluminum Chloride LIQUID TOPICAL 20140506 OTC MONOGRAPH FINAL part350 The Podiatree Co ALUMINUM CHLORIDE 15 g/100mL E 20171231 54633-115_60ca02ac-fc20-0d8f-e053-2991aa0a6f4e 54633-115 HUMAN OTC DRUG Veraciti salicylic acid GEL TOPICAL 20151001 OTC MONOGRAPH FINAL part358B The Podiatree Company SALICYLIC ACID 17 g/100g N 20181231 54633-201_c0cea7f6-24bb-4efc-9e67-37835acf6b03 54633-201 HUMAN OTC DRUG K2 Cold Therapy Menthol LIQUID TOPICAL 20140506 OTC MONOGRAPH NOT FINAL part348 The Podiatree Co MENTHOL 10 g/100mL E 20171231 54633-214_60dcd391-7bf3-9ec2-e053-2991aa0a4a17 54633-214 HUMAN OTC DRUG Fortinia clotrimazole 1% SOLUTION TOPICAL 20141001 OTC MONOGRAPH FINAL part333C The Podiatree Company CLOTRIMAZOLE 1 g/100mL N 20181231 54633-216_60c88eb7-22ff-4881-e053-2a91aa0a70ce 54633-216 HUMAN OTC DRUG Fortinia ID phenol LIQUID TOPICAL 20170103 OTC MONOGRAPH NOT FINAL part333A The Podiatree Company PHENOL 1.5 g/100mL N 20181231 54633-314_60ba7ee8-7134-c6bb-e053-2a91aa0ac466 54633-314 HUMAN OTC DRUG Fortinia Clotrimazole CREAM TOPICAL 20150202 OTC MONOGRAPH FINAL part333C The Podiatree Company CLOTRIMAZOLE 10 mg/g N 20181231 54633-413_60b91648-c805-7468-e053-2991aa0a6c1e 54633-413 HUMAN OTC DRUG Aarica Aluminum Chloride LIQUID TOPICAL 20140506 OTC MONOGRAPH FINAL part350 The Podiatree Company ALUMINUM CHLORIDE 15 g/100mL N 20181231 54633-414_625ba6c8-a04b-12c9-e053-2991aa0aad86 54633-414 HUMAN OTC DRUG K2 Cold Therapy Menthol LIQUID TOPICAL 20140506 OTC MONOGRAPH NOT FINAL part348 The Podiatree Co MENTHOL 10 g/100mL N 20191231 54633-612_60de23d0-6e76-3b97-e053-2a91aa0aea5e 54633-612 HUMAN OTC DRUG Castellani Paint 1.5% phenol LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A The Podiatree Company PHENOL 15 mg/mL N 20181231 54633-712_60dcc23a-940e-15aa-e053-2a91aa0a549f 54633-712 HUMAN OTC DRUG Castellani Paint 1.5% phenol LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A The Podiatree Company PHENOL 15 mg/mL N 20181231 54633-913_60b9aa2d-ae5b-567b-e053-2a91aa0a1e29 54633-913 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, POWDER TOPICAL 20130701 OTC MONOGRAPH FINAL part333C The Podiatree Company TOLNAFTATE 1 g/100g N 20181231 54638-0001_bc934c45-e26f-4767-8813-d3f6f08efee0 54638-0001 HUMAN OTC DRUG REHYDRATE Avena Sativa, Equisetum Hyemale, hypericum perforatum, Ulmus Fulva, Glycyrrhiza Glabra, Pueraria Lobata, Wildbad Aqua, Carlsbad Aqua LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC ParaDocs All Natural Inc. AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; HYPERICUM PERFORATUM; ULMUS RUBRA BARK; GLYCYRRHIZA GLABRA; PUERARIA MONTANA VAR. LOBATA WHOLE; WATER; ADENOSINE TRIPHOSPHATE; GERMANIUM SESQUIOXIDE; HYDROGEN; OXYGEN 3; 4; 6; 6; 12; 12; 6; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 54638-0003_78082bd1-544c-4267-b4a0-0641f9b49464 54638-0003 HUMAN OTC DRUG Rehydrate Avena Sativa, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Glycyrrhiza Glabra, Silicea, Pueraria Lobata, Carlsbad Aqua, Adenosinum Triphosphoricum Dinatrum, Germanium Sesquioxide, Hydrogen, Oxygen, Wiesbaden LIQUID ORAL 20150212 UNAPPROVED HOMEOPATHIC ParaDocs All Natural, Inc. AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; HYPERICUM PERFORATUM; ULMUS RUBRA BARK; GLYCYRRHIZA GLABRA; SILICON DIOXIDE; PUERARIA MONTANA VAR. LOBATA ROOT; WATER; ADENOSINE TRIPHOSPHATE DISODIUM; GERMANIUM SESQUIOXIDE; HYDROGEN; OXYGEN 3; 4; 6; 6; 12; 12; 8; 12; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 54641-003_b485f619-886d-49c8-90a6-3445e756c57d 54641-003 HUMAN OTC DRUG Flex24 Pain Pen camphor LIQUID TOPICAL 20150210 OTC MONOGRAPH NOT FINAL part348 Larasan Pharmaceutical Corporation CAMPHOR (NATURAL) 7.79 g/100mL N 20181231 54641-004_634cdaa7-f371-4117-a024-f109ffda7bc7 54641-004 HUMAN OTC DRUG Flex24 Performance Pen camphor LIQUID TOPICAL 20140408 OTC MONOGRAPH NOT FINAL part348 Larasan Pharmaceutical Corporation CAMPHOR (NATURAL) 7.79 g/100mL N 20181231 54641-005_9cf5857a-71cf-48fe-ae48-efdf959d291f 54641-005 HUMAN OTC DRUG Flex24 Pain Camphor Menthol PATCH TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part348 Larasan Pharmaceutical Corporation CAMPHOR (NATURAL); MENTHOL 3; 2.52 g/100g; g/100g N 20181231 54641-006_bf79e636-29bd-4642-b7be-17cdb4412215 54641-006 HUMAN OTC DRUG Flex24 Performance Camphor, Menthol PATCH TOPICAL 20140408 OTC MONOGRAPH NOT FINAL part348 Larasan Pharmaceutical Corporation CAMPHOR (NATURAL); MENTHOL 3; 2.52 g/100g; g/100g N 20181231 54641-007_5d7c087a-6fc4-4794-8db2-d919215bff9c 54641-007 HUMAN OTC DRUG Flex24 Performance Camphor Menthol PATCH TOPICAL 20170116 OTC MONOGRAPH NOT FINAL part348 Larasan Pharmaceutical Corporation CAMPHOR (NATURAL); MENTHOL 3; 2.52 g/100g; g/100g N 20181231 54643-5646_2e3c2e71-a3b8-48bf-8e95-96299424cad5 54643-5646 HUMAN PRESCRIPTION DRUG Pediatric Infuvite Multiple Vitamins for Infusion Asorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin 5-phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Fo INJECTION, SOLUTION INTRAVENOUS 20010221 NDA NDA021265 Sandoz Canada Inc ASCORBIC ACID; VITAMIN A PALMITATE; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; NIACINAMIDE; DEXPANTHENOL; ALPHA-TOCOPHEROL ACETATE; PHYTONADIONE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN 80; 2300; 400; 1.2; 1.4; 1; 17; 5; 7; .2; 140; 20; 1 mg/5mL; [iU]/5mL; [iU]/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; [iU]/5mL; mg/5mL; ug/5mL; ug/5mL; ug/5mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 54643-5647_474b0f3d-0928-48a2-99eb-fd121f20b2c6 54643-5647 HUMAN PRESCRIPTION DRUG Pediatric Infuvite Multiple Vitamins Asorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin KIT 20040129 NDA NDA021646 Sandoz Canada Inc N 20181231 54643-5649_b8f469b1-9393-4541-bef4-1ecf3e05cece 54643-5649 HUMAN PRESCRIPTION DRUG Infuvite Adult Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin INJECTION, SOLUTION INTRAVENOUS 20050518 NDA NDA021163 Sandoz Canada Inc ASCORBIC ACID; VITAMIN A PALMITATE; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; NIACINAMIDE; DEXPANTHENOL; .ALPHA.-TOCOPHEROL ACETATE; PHYTONADIONE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN 200; 3300; 200; 6; 3.6; 6; 40; 15; 10; 150; 600; 60; 5 mg/10mL; [iU]/10mL; [iU]/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; [iU]/10mL; ug/10mL; ug/10mL; ug/10mL; ug/10mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 54643-5650_b8f469b1-9393-4541-bef4-1ecf3e05cece 54643-5650 HUMAN PRESCRIPTION DRUG Infuvite Adult Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin INJECTION, SOLUTION INTRAVENOUS 20030616 NDA NDA021559 Sandoz Canada Inc ASCORBIC ACID; VITAMIN A PALMITATE; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; NIACINAMIDE; DEXPANTHENOL; .ALPHA.-TOCOPHEROL ACETATE; PHYTONADIONE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN 200; 3300; 200; 6; 3.6; 6; 40; 15; 10; 150; 600; 60; 5 mg/10mL; [iU]/10mL; [iU]/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; [iU]/10mL; ug/10mL; ug/10mL; ug/10mL; ug/10mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 54643-7862_f10e7c39-b9ce-4d3b-98e0-891ccb8d0b1a 54643-7862 HUMAN PRESCRIPTION DRUG Adult Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin INJECTION, SOLUTION INTRAVENOUS 20050518 NDA NDA021163 Sandoz Canada Inc ASCORBIC ACID; VITAMIN A PALMITATE; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; NIACINAMIDE; DEXPANTHENOL; .ALPHA.-TOCOPHEROL ACETATE; PHYTONADIONE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN 200; 3300; 200; 6; 3.6; 6; 40; 15; 10; 150; 600; 60; 5 mg/10mL; [iU]/10mL; [iU]/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; [iU]/10mL; ug/10mL; ug/10mL; ug/10mL; ug/10mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 54643-7874_f10e7c39-b9ce-4d3b-98e0-891ccb8d0b1a 54643-7874 HUMAN PRESCRIPTION DRUG Adult Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin INJECTION, SOLUTION INTRAVENOUS 20030616 NDA NDA021559 Sandoz Canada Inc ASCORBIC ACID; VITAMIN A PALMITATE; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; NIACINAMIDE; DEXPANTHENOL; .ALPHA.-TOCOPHEROL ACETATE; PHYTONADIONE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN 200; 3300; 200; 6; 3.6; 6; 40; 15; 10; 150; 600; 60; 5 mg/10mL; [iU]/10mL; [iU]/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; [iU]/10mL; ug/10mL; ug/10mL; ug/10mL; ug/10mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 54643-7886_02064c66-3f2d-4502-a96d-800a4d128593 54643-7886 HUMAN PRESCRIPTION DRUG Pediatric Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin INJECTION, SOLUTION INTRAVENOUS 20010221 NDA NDA021265 Sandoz Canada Inc ASCORBIC ACID; VITAMIN A PALMITATE; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; NIACINAMIDE; DEXPANTHENOL; .ALPHA.-TOCOPHEROL ACETATE; PHYTONADIONE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN 80; 2300; 400; 1.2; 1.4; 1; 17; 5; 7; .2; 140; 20; 1 mg/5mL; [iU]/5mL; [iU]/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; [iU]/5mL; mg/5mL; ug/5mL; ug/5mL; ug/5mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 54643-7898_02064c66-3f2d-4502-a96d-800a4d128593 54643-7898 HUMAN PRESCRIPTION DRUG Pediatric Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin KIT 20040129 NDA NDA021646 Sandoz Canada Inc N 20181231 54643-9007_4c8d32a4-3334-434b-a828-979d087a6ed9 54643-9007 HUMAN PRESCRIPTION DRUG Adult Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin INJECTION, SOLUTION INTRAVENOUS 20050518 NDA NDA021163 Sandoz Canada Inc ASCORBIC ACID; VITAMIN A PALMITATE; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; NIACINAMIDE; DEXPANTHENOL; .ALPHA.-TOCOPHEROL ACETATE; PHYTONADIONE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN 200; 3300; 200; 6; 3.6; 6; 40; 15; 10; 150; 600; 60; 5 mg/10mL; [iU]/10mL; [iU]/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; [iU]/10mL; ug/10mL; ug/10mL; ug/10mL; ug/10mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 54643-9015_4c8d32a4-3334-434b-a828-979d087a6ed9 54643-9015 HUMAN PRESCRIPTION DRUG Adult Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin INJECTION, SOLUTION INTRAVENOUS 20030616 NDA NDA021559 Sandoz Canada Inc ASCORBIC ACID; VITAMIN A PALMITATE; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; NIACINAMIDE; DEXPANTHENOL; .ALPHA.-TOCOPHEROL ACETATE; PHYTONADIONE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN 200; 3300; 200; 6; 3.6; 6; 40; 15; 10; 150; 600; 60; 5 mg/10mL; [iU]/10mL; [iU]/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; [iU]/10mL; ug/10mL; ug/10mL; ug/10mL; ug/10mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 54643-9023_4ff223f7-e076-4e81-8151-5c06724fabd9 54643-9023 HUMAN PRESCRIPTION DRUG Pediatric Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin INJECTION, SOLUTION INTRAVENOUS 20161223 NDA NDA021265 Sandoz Canada Inc ASCORBIC ACID; VITAMIN A PALMITATE; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; NIACINAMIDE; DEXPANTHENOL; .ALPHA.-TOCOPHEROL ACETATE; PHYTONADIONE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN 80; 2300; 400; 1.2; 1.4; 1; 17; 5; 7; .2; 140; 20; 1 mg/5mL; [iU]/5mL; [iU]/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; [iU]/5mL; mg/5mL; ug/5mL; ug/5mL; ug/5mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 54643-9031_4ff223f7-e076-4e81-8151-5c06724fabd9 54643-9031 HUMAN PRESCRIPTION DRUG Pediatric Infuvite Multiple Vitamins Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin KIT 20161223 NDA NDA021646 Sandoz Canada Inc N 20181231 54679-0001_381f221b-b9e6-42c6-9e4d-7943176958ac 54679-0001 HUMAN OTC DRUG Antimicrobial Hand Lotion Soap 652 HAND SANITIZER LOTION TOPICAL 19940101 OTC MONOGRAPH FINAL part333 Montgomery County Chapter Nysarc, Inc dba Liberty Enterprises CHLOROXYLENOL 3.6 mL/800mL N 20181231 54679-6657_2ba46c25-07b2-493a-8b9d-a221648496a5 54679-6657 HUMAN OTC DRUG INSTANT HAND SANITIZER HAND SANITIZER GEL TOPICAL 19980101 OTC MONOGRAPH FINAL part333 Montgomery County Chapter Nysarc, Inc dba Liberty Enterprises ALCOHOL 62 mL/100mL N 20181231 54702-501_3029bbfd-255f-4597-ae1a-fd6939b67c30 54702-501 HUMAN PRESCRIPTION DRUG ORALTAG Iohexol FOR SOLUTION ORAL 20160701 NDA NDA205383 Interpharma Praha, a.s. IOHEXOL 4.5 g/1 Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 54705-000_3a60bfad-ad5f-4284-a75e-d170e0990e60 54705-000 HUMAN OTC DRUG Air-Vita Allergy Allium cepa, Ambrosia artemisiaefolia, Apis mellifica, Chamomilla, Eucalyptol, Eucalyptus globulus, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Natrum muriaticum, Nux vomica, Quercus robur, Silicea, Wyethia helenioides LIQUID ORAL 20141028 UNAPPROVED HOMEOPATHIC Flutrends International Corporation ONION; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; MATRICARIA RECUTITA; EUCALYPTOL; EUCALYPTUS GLOBULUS LEAF; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; QUERCUS ROBUR TWIG BARK; SILICON DIOXIDE; WYETHIA HELENIOIDES ROOT 10; 12; 30; 18; 3; 3; 12; 4; 12; 10; 15; 4; 8; 12 [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL; [hp_X]/28mL N 20181231 54705-160_8662a07c-ad6b-48ef-9832-107ce2bd07e6 54705-160 HUMAN OTC DRUG FluNada Cold and Flu Relief EUCALYPTOL, EUCALYPTUS GLOBULUS WHOLE, MENTHOL, SAMBUCUS NIGRA WHOLE, METHYL SALICYLATE SPRAY, METERED NASAL; ORAL 20121218 UNAPPROVED HOMEOPATHIC Flutrends International Corporation EUCALYPTOL; EUCALYPTUS GLOBULUS WHOLE; MENTHOL; SAMBUCUS NIGRA WHOLE; METHYL SALICYLATE 3; 3; 4; 2; 3 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 54706-0001_4446b3c0-6019-44d5-8bb2-583518641f4f 54706-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100112 UNAPPROVED MEDICAL GAS Garrett County Memorial Hospital OXYGEN 99 L/100L E 20171231 54723-100_e1089155-98d6-4171-bac3-0d25b49b8a35 54723-100 HUMAN OTC DRUG Predator LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 40 mg/g E 20171231 54723-101_2a1793fd-ffbe-4170-8cb0-32ec9485635b 54723-101 HUMAN OTC DRUG Predator Lidocaine Hydrochloride CREAM TOPICAL 20130211 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 400 mg/mg E 20171231 54723-150_11d17149-b258-462f-971e-cb481a2a7e91 54723-150 HUMAN OTC DRUG Predator Lidocaine HCL CREAM TOPICAL 20130211 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 400 mg/mg E 20171231 54723-175_4b62f7bf-48a7-4617-a351-b61a293942ca 54723-175 HUMAN OTC DRUG NeuroMed 7 Topical Pain Relief LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE 4 g/100g N 20181231 54723-235_8a5a7803-7ddd-431b-8038-7ed24115af0c 54723-235 HUMAN OTC DRUG Plush anesthetics B Benzocaine CREAM TOPICAL 20171106 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. BENZOCAINE 20 mg/100mg N 20181231 54723-236_a35584a5-5b92-4788-a288-709ae6c8a23e 54723-236 HUMAN OTC DRUG Plush anesthetics L LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20171106 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 54723-237_1c6cde02-d5fb-438f-b593-f7f49a222d17 54723-237 HUMAN OTC DRUG Plush anesthetics T Tetracaine HCL CREAM TOPICAL 20171106 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. TETRACAINE HYDROCHLORIDE 2 mg/100mg N 20181231 54723-300_5e9b6630-0bfe-45ba-947e-e834c72c408a 54723-300 HUMAN OTC DRUG NeuroMed Topical Anesthetic 7 LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20150820 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals LIDOCAINE HYDROCHLORIDE 40 mg/g N 20181231 54723-300_a6decb6d-53a4-4b95-92e8-3e903707081f 54723-300 HUMAN OTC DRUG NeuroMed Topical Anesthetic 7 LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals LIDOCAINE HYDROCHLORIDE 40 mg/g N 20181231 54723-310_4a651943-b67c-4082-b55c-03aed68a2a44 54723-310 HUMAN OTC DRUG NeuroMed Topical Analgesic LA Tetracaine HCL CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. TETRACAINE HYDROCHLORIDE 20 mg/1000mg N 20181231 54723-528_bd91334a-7e59-41e9-a017-dbd94380a40f 54723-528 HUMAN OTC DRUG Recovery Numb LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20170627 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals LIDOCAINE HYDROCHLORIDE .04 g/g N 20181231 54723-624_413b37fd-19c0-4db2-b120-9aeb9308fbd6 54723-624 HUMAN OTC DRUG Pain Prescriptives Topical Analgesic FA Benzocaine CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. BENZOCAINE 20 mg/100mg N 20181231 54723-667_15cb9702-3296-4394-ba74-f2742fee7db9 54723-667 HUMAN OTC DRUG Eclipse Topical Anesthetic LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20170503 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals LIDOCAINE HYDROCHLORIDE 40 mg/g N 20181231 54723-667_ce743eaa-9592-4d17-bbf1-324dc0cfae05 54723-667 HUMAN OTC DRUG Eclipse Topical Anesthetic LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20150820 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals LIDOCAINE HYDROCHLORIDE 40 mg/g N 20181231 54723-667_d2d04025-1405-4ee8-83af-0482996d1a6e 54723-667 HUMAN OTC DRUG Eclipse Topical Anesthetic LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20150820 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals LIDOCAINE HYDROCHLORIDE 40 mg/g N 20181231 54723-668_1733f813-e742-4708-a98a-36f8b0b42c7e 54723-668 HUMAN OTC DRUG Eclipse Topical Analgesic FA Benzocaine CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. BENZOCAINE 20 mg/100mg N 20181231 54723-668_41179090-e5f1-4be1-ac2b-c4382c562a1a 54723-668 HUMAN OTC DRUG Eclipse Topical Analgesic FA Benzocaine CREAM TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. BENZOCAINE 20 mg/100mg N 20181231 54723-668_6b284d99-3ab8-4494-9f2f-f52740becc55 54723-668 HUMAN OTC DRUG Eclipse Topical Analgesic FA Benzocaine CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. BENZOCAINE 20 mg/100mg N 20181231 54723-669_2524bcfd-4b1f-4972-b1d8-d14450f3ff90 54723-669 HUMAN OTC DRUG Eclipse Topical Analgesic LL Tetracaine HCL CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. TETRACAINE HYDROCHLORIDE 20 mg/1000mg N 20181231 54723-669_679fc613-d100-442f-ad75-891f0a915762 54723-669 HUMAN OTC DRUG Eclipse Topical Analgesic LL Tetracaine HCL CREAM TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. TETRACAINE HYDROCHLORIDE 20 mg/1000mg N 20181231 54723-669_dd2706ca-6f70-464c-9015-90ad8ed51c5b 54723-669 HUMAN OTC DRUG Eclipse Topical Analgesic LL Tetracaine HCL CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. TETRACAINE HYDROCHLORIDE 20 mg/1000mg N 20181231 54723-719_cac6c523-7a55-44c1-9c3c-a8043998c0b5 54723-719 HUMAN OTC DRUG Pain Prescriptives 5 LIDOCAINE CREAM TOPICAL 20151222 20180523 OTC MONOGRAPH FINAL part346 Sambria Pharmaceuticals LIDOCAINE 50 mg/mL E 20171231 54723-722_3b5e36e9-687a-4d2e-aa78-32ef573f8912 54723-722 HUMAN OTC DRUG NeuroMed FA Benzocaine CREAM TOPICAL 20170821 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. BENZOCAINE 20 mg/100mg N 20181231 54723-722_d812c2f9-0e90-46a0-b096-e49bd495a4b0 54723-722 HUMAN OTC DRUG NeuroMed FA Benzocaine CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. BENZOCAINE 20 mg/100mg N 20181231 54723-724_b83d916c-3a46-41be-a005-352e8a517fc7 54723-724 HUMAN OTC DRUG Pain Prescriptives 4 LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20150820 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals LIDOCAINE HYDROCHLORIDE 40 mg/g N 20181231 54723-725_269258e3-fa3f-4cb5-b14b-4f77cd14bfa9 54723-725 HUMAN OTC DRUG Pain Prescriptives Topical Analgesic LL Tetracaine HCL CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. TETRACAINE HYDROCHLORIDE 20 mg/1000mg N 20181231 54723-997_bdbded8f-32da-4102-a1c3-8357f7d4d278 54723-997 HUMAN OTC DRUG Comfortox Tetracaine Tetracaine HCL CREAM TOPICAL 20160914 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. TETRACAINE HYDROCHLORIDE 20 mg/1000mg N 20181231 54723-998_561b8d1e-145a-4feb-9057-022a3a1d701e 54723-998 HUMAN OTC DRUG Comfortox Lidocaine LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20160914 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 54723-999_067c43cb-0862-49a3-8a85-359010800c18 54723-999 HUMAN OTC DRUG Comfortox Benzocaine Benzocaine CREAM TOPICAL 20160907 OTC MONOGRAPH NOT FINAL part348 Sambria Pharmaceuticals, Inc. BENZOCAINE 20 mg/100mg N 20181231 54726-0100_811451ab-cc59-4c42-bf01-3b80926f58a2 54726-0100 HUMAN OTC DRUG St. Ives Blemish and Blackhead control Salicylic Acid EMULSION TOPICAL 20110223 OTC MONOGRAPH FINAL part333D Cosmetic Laboratories of America SALICYLIC ACID .02 g/g E 20171231 54726-0200_4b7b7c06-17b0-4caf-a4f8-383ed4a8bff4 54726-0200 HUMAN OTC DRUG St. Ives Blemish and Blackhead Facial Wash Salicylic Acid SOAP TOPICAL 20110228 OTC MONOGRAPH FINAL part333D Cosmetic Laboratories of America SALICYLIC ACID .02 g/mL E 20171231 54726-0500_e3ac1218-97ee-42d9-b030-7d3e266eb28f 54726-0500 HUMAN OTC DRUG ST. IVES BODY SCRUB NATURALLY CLEAR SKIN GREEN TEA Salicylic Acid EMULSION TOPICAL 20110214 OTC MONOGRAPH FINAL part333D Cosmetic Laboratories of America SALICYLIC ACID .02 mL/mL E 20171231 54726-0600_067229ed-f1fb-4506-9e18-94499b15630e 54726-0600 HUMAN OTC DRUG ST. IVES BODY WASH NATURALLY CLEAR SKIN GREEN TEA Salicylic Acid SOAP TOPICAL 20110214 OTC MONOGRAPH FINAL part333D Cosmetic Laboratories of America SALICYLIC ACID .02 mL/mL E 20171231 54726-2000_776c244d-d5c0-427f-bc9c-32e43af267df 54726-2000 HUMAN OTC DRUG Simple Vital Vitamin Day SPF 15 Homosalate, Octisalate, Avobenzone, and Octocrylene EMULSION TOPICAL 20120101 OTC MONOGRAPH FINAL part352 Cosmetic Laboratories of America HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE .12; .05; .03; .027 g/g; g/g; g/g; g/g E 20171231 54738-020_5cc6cec2-9f03-6cf9-e053-2991aa0ada77 54738-020 HUMAN OTC DRUG SODIUM BICARBONATE SODIUM BICARBONATE TABLET ORAL 20150501 OTC MONOGRAPH FINAL part331 Richmond Pharmaceuticals, Inc. SODIUM BICARBONATE 650 mg/1 N 20181231 54738-025_5cc4c45d-5b77-0912-e053-2991aa0a10a5 54738-025 HUMAN OTC DRUG Meclizine HCL Meclizine HCl 25mg Chewable Tablets TABLET, CHEWABLE ORAL 20150501 OTC MONOGRAPH FINAL part336 Richmond Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 54738-030_5cc88da4-0292-200b-e053-2a91aa0ab317 54738-030 HUMAN OTC DRUG ANTACID Calcium Carbonate TABLET, CHEWABLE ORAL 20150501 OTC MONOGRAPH FINAL part331 Richmond Pharmaceuticals, Inc. CALCIUM CARBONATE 500 mg/1 N 20181231 54738-035_5cec472c-8a20-32e5-e053-2991aa0a3222 54738-035 HUMAN OTC DRUG Sodium Bicarbonate Antacid Sodium Bicarbonate TABLET ORAL 20150601 OTC MONOGRAPH FINAL part331 Richmond Pharmaceuticals, Inc. SODIUM BICARBONATE 325 mg/1 N 20181231 54738-040_5cc3aaa6-e19e-a116-e053-2991aa0a1422 54738-040 HUMAN OTC DRUG APAP Acetaminophen TABLET ORAL 20150401 OTC MONOGRAPH NOT FINAL part343 Richmond Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 54738-092_5cc5fab2-77b5-05c5-e053-2991aa0a272d 54738-092 HUMAN OTC DRUG Chewable Acetaminophen Childrens Acetaminophen TABLET, CHEWABLE ORAL 20150401 OTC MONOGRAPH NOT FINAL part343 Richmond Pharmaceuticals, Inc. ACETAMINOPHEN 80 mg/1 N 20181231 54738-102_5cc53a8f-4daa-7cff-e053-2991aa0a383b 54738-102 HUMAN OTC DRUG Pepto Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20150601 OTC MONOGRAPH FINAL part335 Richmond Pharmaceuticals, Inc BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 54738-103_5cc3ebfe-ce74-423d-e053-2a91aa0a4616 54738-103 HUMAN OTC DRUG Anti Allergy Chlorpheniramine Maleate TABLET ORAL 20150501 OTC MONOGRAPH FINAL part341 Richmond Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 54738-111_5cc3bf1b-4678-6a53-e053-2a91aa0abfa6 54738-111 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20150501 OTC MONOGRAPH FINAL part343 Richmond Pharmaceuticals, Inc ASPIRIN 325 mg/1 N 20181231 54738-115_215d1ac5-309f-4bb5-a37d-0546b9913d35 54738-115 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20000215 OTC MONOGRAPH FINAL part341 Richmond Pharmaceuticals Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 54738-115_5cc3bf1b-4660-6a53-e053-2a91aa0abfa6 54738-115 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20150501 OTC MONOGRAPH FINAL part341 Richmond Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 54738-116_215d1ac5-309f-4bb5-a37d-0546b9913d35 54738-116 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20000215 OTC MONOGRAPH FINAL part341 Richmond Pharmaceuticals Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 54738-116_5cc3bf1b-466c-6a53-e053-2a91aa0abfa6 54738-116 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20150501 OTC MONOGRAPH FINAL part341 Richmond Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 54738-128_5cc44dca-00c9-b589-e053-2a91aa0a0521 54738-128 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 20150401 OTC MONOGRAPH FINAL part343 Richmond Pharmaceuticals, Inc. ASPIRIN 81 mg/1 N 20181231 54738-518_5cc86981-732a-038f-e053-2991aa0a19d4 54738-518 HUMAN OTC DRUG Simethicone Simethicone TABLET, CHEWABLE ORAL 20110301 OTC MONOGRAPH FINAL part332 Richmond Pharmaceuticals, Inc. DIMETHICONE 80 mg/1 N 20181231 54738-540_5cc3aaa6-e1aa-a116-e053-2991aa0a1422 54738-540 HUMAN OTC DRUG APAP Acetaminophen TABLET ORAL 20150401 OTC MONOGRAPH NOT FINAL part343 Richmond Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 54738-541_5cc3ebfe-ce68-423d-e053-2a91aa0a4616 54738-541 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20150601 OTC MONOGRAPH FINAL part343 Richmond Pharmaceuticals, Inc. ASPIRIN 325 mg/1 N 20181231 54738-548_5cc3aaa6-e192-a116-e053-2991aa0a1422 54738-548 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20150501 OTC MONOGRAPH NOT FINAL part343 Richmond Pharmaceuticals, Inc. ACETAMINOPHEN 325 mg/1 N 20181231 54738-554_4cf9902d-6772-4e76-ba49-29102fa3d1a5 54738-554 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 19981224 ANDA ANDA040254 Richmond Pharmaceuticals, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 E 20171231 54738-555_4cf9902d-6772-4e76-ba49-29102fa3d1a5 54738-555 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 19981224 ANDA ANDA040254 Richmond Pharmaceuticals, Inc. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 E 20171231 54738-559_5cec1103-cec1-0e47-e053-2991aa0a32c5 54738-559 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20150401 OTC MONOGRAPH FINAL part343 Richmond Pharmaceuticals, Inc. ASPIRIN 81 mg/1 N 20181231 54738-901_83f95b44-22e6-49cd-8aa9-8c56f76c4fa0 54738-901 HUMAN PRESCRIPTION DRUG Quinidine Gluconate Quinidine Gluconate TABLET, EXTENDED RELEASE ORAL 19870210 ANDA ANDA089338 Richmond Pharmaceuticals, Inc. QUINIDINE GLUCONATE 324 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 54738-902_034a7f71-4589-441c-b585-d57be8942b80 54738-902 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20090904 ANDA ANDA072050 Richmond Pharmaceuticals SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54738-903_034a7f71-4589-441c-b585-d57be8942b80 54738-903 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20090904 ANDA ANDA072051 Richmond Pharmaceuticals SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54738-904_629af246-20ec-4343-e053-2a91aa0a0d71 54738-904 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 20181130 ANDA ANDA075896 Richmond Pharmaceuticals, Inc. FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 54738-905_629af246-20ec-4343-e053-2a91aa0a0d71 54738-905 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 20181130 ANDA ANDA075896 Richmond Pharmaceuticals, Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 54738-906_629af246-20ec-4343-e053-2a91aa0a0d71 54738-906 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 20181130 ANDA ANDA075896 Richmond Pharmaceuticals, Inc. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 54738-907_eb6c8ff1-1c68-444a-b72e-c97b63698ea7 54738-907 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 Richmond Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54738-908_eb6c8ff1-1c68-444a-b72e-c97b63698ea7 54738-908 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19870904 ANDA ANDA070924 Richmond Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54738-909_eb6c8ff1-1c68-444a-b72e-c97b63698ea7 54738-909 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19870904 ANDA ANDA070923 Richmond Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54738-912_615a19f8-e9e0-4366-e053-2a91aa0adb4d 54738-912 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 20201231 ANDA ANDA081048 Richmond Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 54738-913_615a19f8-e9e0-4366-e053-2a91aa0adb4d 54738-913 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 20201231 ANDA ANDA081049 Richmond Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 54738-914_615a19f8-e9e0-4366-e053-2a91aa0adb4d 54738-914 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19900605 20201231 ANDA ANDA081050 Richmond Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 54738-950_399b0f79-8b12-49d9-bb74-302ff46671e9 54738-950 HUMAN PRESCRIPTION DRUG ribavirin ribavirin TABLET, FILM COATED ORAL 20080601 ANDA ANDA077456 Richmond Pharmaceuticals, Inc. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 54738-951_399b0f79-8b12-49d9-bb74-302ff46671e9 54738-951 HUMAN PRESCRIPTION DRUG ribavirin ribavirin TABLET, FILM COATED ORAL 20080601 ANDA ANDA077456 Richmond Pharmaceuticals, Inc. RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 54738-952_399b0f79-8b12-49d9-bb74-302ff46671e9 54738-952 HUMAN PRESCRIPTION DRUG ribavirin ribavirin TABLET, FILM COATED ORAL 20080601 ANDA ANDA077456 Richmond Pharmaceuticals, Inc. RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 54738-953_40db910b-e769-4a1a-ac96-e14720af471b 54738-953 HUMAN PRESCRIPTION DRUG ribavirin ribavirin CAPSULE ORAL 20071101 ANDA ANDA076203 Richmond Pharmaceuticals, Inc. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 54738-963_39803ffc-abf0-4bfb-a5db-9612d2116f1f 54738-963 HUMAN OTC DRUG Ferrous Sulfate Ferrous Sulfate TABLET ORAL 20081105 UNAPPROVED DRUG OTHER Richmond Pharmaceuticals Inc. FERROUS SULFATE 325 mg/1 N 20181231 54738-963_5cc53a8f-4e6f-7cff-e053-2991aa0a383b 54738-963 HUMAN OTC DRUG FERROUS SULFATE FERROUS SULFATE TABLET ORAL 20150601 UNAPPROVED DRUG OTHER Richmond Pharmaceuticals, Inc. FERROUS SULFATE 325 mg/1 N 20181231 54738-974_5cc9ad26-b551-6d85-e053-2991aa0a7bff 54738-974 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20160201 OTC MONOGRAPH FINAL part331 Richmond Pharmaceuticals, Inc. MAGNESIUM OXIDE 420 mg/1 N 20181231 54738-974_5da2d8b4-1166-9aae-e053-2a91aa0a9f76 54738-974 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20160201 OTC MONOGRAPH FINAL part331 Richmond Pharmaceuticals, Inc. MAGNESIUM OXIDE 420 mg/1 N 20181231 54738-981_5cc3bf1b-4684-6a53-e053-2a91aa0abfa6 54738-981 HUMAN OTC DRUG Mucus Relief Guaifenesin 400 mg TABLET ORAL 20160301 OTC MONOGRAPH FINAL part341 Richmond Pharmaceuticals, Inc. GUAIFENESIN 400 mg/1 N 20181231 54738-985_5cc409a8-23e1-738f-e053-2a91aa0ac0d5 54738-985 HUMAN OTC DRUG Mucus Relief Cough and Congestion DM Guaifenesin and Dextromethorphan HBr TABLET ORAL 20160401 OTC MONOGRAPH FINAL part341 Richmond Pharmaceuticals, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 54746-001_5fc3a89f-9528-3d86-e053-2991aa0af9b1 54746-001 HUMAN PRESCRIPTION DRUG Alferon interferon alfa-n3 INJECTION SUBCUTANEOUS 19891010 BLA BLA103158 Hemispherx Biopharma, Inc INTERFERON ALFA-N3 5000000 [arb'U]/mL Interferon alpha [EPC],Interferon-alpha [Chemical/Ingredient] N 20181231 54748-101_89e43605-985d-4b8c-ad8b-571b6ae6f3a4 54748-101 HUMAN OTC DRUG EO HAND SANITIZER Lavender alcohol SPRAY TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54748-102_3e7913b0-6b2f-48ae-be7b-8ffd44344226 54748-102 HUMAN OTC DRUG EO HAND SANITIZER Peppermint alcohol SPRAY TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54748-103_9f62ba7d-49ad-4785-abfa-7956f4e2e369 54748-103 HUMAN OTC DRUG EO HAND SANITIZER Sweet Orange alcohol SPRAY TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54748-104_d0272378-f109-4ff4-aff9-96f0b92fe8f5 54748-104 HUMAN OTC DRUG EO HAND SANITIZER Lavender alcohol SPRAY TOPICAL 20170519 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54748-105_e47842bb-bcb2-429f-875d-16b71691d073 54748-105 HUMAN OTC DRUG EO HAND SANITIZER Peppermint alcohol SPRAY TOPICAL 20170519 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54748-106_af2d8e2c-42eb-4b3f-93da-6465f0b38826 54748-106 HUMAN OTC DRUG EO HAND sanitizer geranium Alcohol SPRAY TOPICAL 20171105 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54748-201_55f28cc5-b4de-4bb2-939c-020ec4ae7bb1 54748-201 HUMAN OTC DRUG EO HAND SANITIZER Lavender alcohol GEL TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54748-202_9c976076-4b3f-4f4f-b5b3-5ea99bf78549 54748-202 HUMAN OTC DRUG EO HAND SANITIZER Lemon alcohol GEL TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL E 20171231 54748-203_659cda4f-9a15-4ce2-966d-20a71482a0ce 54748-203 HUMAN OTC DRUG EO HAND SANITIZER Unscented alcohol GEL TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54748-301_6b274506-9e87-4343-91d7-e83b1f35d159 54748-301 HUMAN OTC DRUG everyone Hand Sanitizer Coconut Lemon alcohol SPRAY TOPICAL 20130607 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL E 20171231 54748-302_7c8becbd-d677-4b78-8fcc-9246d2b2ebba 54748-302 HUMAN OTC DRUG everyone Hand Sanitizer Peppermint Citrus alcohol SPRAY TOPICAL 20130607 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL E 20171231 54748-303_0e82386b-600c-46f6-b44a-bd8b29246bb2 54748-303 HUMAN OTC DRUG Everyone Hand Sanitizer Lavender Aloe alcohol SPRAY TOPICAL 20170215 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54748-401_070ea9e3-b4ff-4118-9160-67da18ea33b7 54748-401 HUMAN OTC DRUG everyone Hand Sanitizer Coconut Lemon alcohol GEL TOPICAL 20130607 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL E 20171231 54748-401_7bd28c14-2180-4618-950b-eeafd948569e 54748-401 HUMAN OTC DRUG everyone Hand Sanitizer Coconut Lemon alcohol GEL TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL E 20171231 54748-401_d93275ab-6215-4d7b-b57c-958a2a3a42a0 54748-401 HUMAN OTC DRUG everyone hand SANITIZER Coconut Lemon alcohol GEL TOPICAL 20150515 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL E 20171231 54748-402_7aecc6e1-d4d4-47d2-a563-88f8dcb1273c 54748-402 HUMAN OTC DRUG everyone Hand Sanitizer Peppermint Citrus alcohol GEL TOPICAL 20130607 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL E 20171231 54748-403_c0a58e44-6735-41e0-847d-42afe6255d71 54748-403 HUMAN OTC DRUG Everyone Hand Sanitizer Lavender Aloe ALCOHOL GEL TOPICAL 20170215 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54748-501_b9e8d57d-f4e0-47c7-8ce8-a50f108019d6 54748-501 HUMAN OTC DRUG everyone hand SANITIZER Coconut Lemon alcohol CLOTH TOPICAL 20150515 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL E 20171231 54748-502_b7b5d19f-16f9-40f2-bf5f-67237b5846d8 54748-502 HUMAN OTC DRUG EO Hand Sanitizer Wipes Lavender Alcohol CLOTH TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54748-502_bc15d4ba-8ddd-4044-8f4c-af897f974dab 54748-502 HUMAN OTC DRUG EO Hand Sanitizer Wipes Lavender Alcohol CLOTH TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54748-503_531c3f64-31a2-42a9-af52-4638d8ed0845 54748-503 HUMAN OTC DRUG EO HAND SANITIZING wipes geranium Alcohol CLOTH TOPICAL 20171105 OTC MONOGRAPH NOT FINAL part333A Small World Trading Company ALCOHOL 62 mL/100mL N 20181231 54753-001_422a8663-ef4a-45ea-a8ae-ad8ca71d3f72 54753-001 HUMAN OTC DRUG Athomer Sodium Chloride SPRAY NASAL 20130114 OTC MONOGRAPH FINAL part349 PHARMACOSMETIC-DIAFARM SODIUM CHLORIDE .9 g/100mL E 20171231 54753-002_43ceee78-d717-4115-aeca-fcd8ed68d355 54753-002 HUMAN OTC DRUG Athomer mini Sodium Chloride SPRAY NASAL 20130114 OTC MONOGRAPH FINAL part349 PHARMACOSMETIC-DIAFARM SODIUM CHLORIDE .9 g/100mL E 20171231 54753-003_46fa8d8e-7a0c-4498-8a95-22823f452f82 54753-003 HUMAN OTC DRUG Athomer baby Sodium Chloride SPRAY NASAL 20130114 OTC MONOGRAPH FINAL part349 PHARMACOSMETIC-DIAFARM SODIUM CHLORIDE .9 g/100mL E 20171231 54754-101_d6393e4f-fd08-460e-9398-f09026983b33 54754-101 HUMAN OTC DRUG TREAT AND TINT SKIN PERFECTING BB SPF 30 OCTINOXATE OCTISALATE AVOBENZONE CREAM TOPICAL 20130106 OTC MONOGRAPH FINAL part352 SORME COMPANY INC OCTINOXATE; OCTISALATE; AVOBENZONE 6; 4.5; 1.5 g/100mL; g/100mL; g/100mL E 20171231 54766-093_6063a9b3-f5de-5fb4-e053-2a91aa0af4ac 54766-093 HUMAN PRESCRIPTION DRUG RIDAURA auranofin CAPSULE ORAL 20161215 NDA NDA018689 Sebela Pharmaceuticals Inc. AURANOFIN 3 mg/1 N 20181231 54766-149_60630127-1972-1dd9-e053-2a91aa0a837c 54766-149 HUMAN PRESCRIPTION DRUG Miacalcin calcitonin salmon INJECTION, SOLUTION INTRAMUSCULAR 19860703 20180331 NDA NDA017808 Sebela Pharmaceuticals Inc. CALCITONIN SALMON 200 [iU]/mL Calcitonin [Chemical/Ingredient],Calcitonin [EPC] N 20181231 54766-200_4cd3f029-a5e4-5812-e054-00144ff8d46c 54766-200 HUMAN PRESCRIPTION DRUG Motofen difenoxin and atropine sulfate TABLET ORAL 20170411 NDA NDA017744 Sebela Pharmaceuticals Inc. ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE .025; 1 mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Antidiarrheal [EPC] CIV N 20181231 54766-201_60dabfbb-29f1-56c7-e053-2a91aa0a8291 54766-201 HUMAN PRESCRIPTION DRUG PEXEVA paroxetine mesylate TABLET, FILM COATED ORAL 20170602 NDA NDA021299 Sebela Pharmaceuticals Inc. PAROXETINE MESYLATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54766-202_60dabfbb-29f1-56c7-e053-2a91aa0a8291 54766-202 HUMAN PRESCRIPTION DRUG PEXEVA paroxetine mesylate TABLET, FILM COATED ORAL 20170602 NDA NDA021299 Sebela Pharmaceuticals Inc. PAROXETINE MESYLATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54766-203_60dabfbb-29f1-56c7-e053-2a91aa0a8291 54766-203 HUMAN PRESCRIPTION DRUG PEXEVA paroxetine mesylate TABLET, FILM COATED ORAL 20170602 NDA NDA021299 Sebela Pharmaceuticals Inc. PAROXETINE MESYLATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54766-204_60dabfbb-29f1-56c7-e053-2a91aa0a8291 54766-204 HUMAN PRESCRIPTION DRUG PEXEVA paroxetine mesylate TABLET, FILM COATED ORAL 20170602 NDA NDA021299 Sebela Pharmaceuticals Inc. PAROXETINE MESYLATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54766-590_606101a0-6245-7eff-e053-2a91aa0acadd 54766-590 HUMAN PRESCRIPTION DRUG IMURAN azathioprine TABLET ORAL 20171201 NDA NDA016324 Sebela Pharmaceuticals Inc. AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 54766-708_370fb92a-5bf9-6842-e054-00144ff8d46c 54766-708 HUMAN PRESCRIPTION DRUG Pramosone E Cream 2.5% hydrocortisone acetate 2.5% pramoxine hydrochloride 1% hydrocortisone acetate and pramoxine hydrochloride CREAM TOPICAL 20150629 20190131 UNAPPROVED DRUG OTHER Sebela Pharmaceuticals Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54766-716_6061fb5a-a9e6-1630-e053-2991aa0ac4d8 54766-716 HUMAN PRESCRIPTION DRUG Pramosone Cream hydrocortisone acetate and pramoxine hydrochloride CREAM TOPICAL 20150804 ANDA ANDA085368 Sebela Pharmaceuticals Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54766-726_606227a7-b310-1958-e053-2a91aa0a97f4 54766-726 HUMAN PRESCRIPTION DRUG Pramosone hydrocortisone acetate and pramoxine hydrochloride LOTION TOPICAL 20141016 ANDA ANDA085979 Sebela Pharmaceuticals Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54766-729_606227a7-b2f8-1958-e053-2a91aa0a97f4 54766-729 HUMAN PRESCRIPTION DRUG Pramosone hydrocortisone acetate and pramoxine hydrochloride LOTION TOPICAL 20150702 ANDA ANDA085980 Sebela Pharmaceuticals Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 10; 10 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54766-760_60636fa0-18a3-3875-e053-2a91aa0acb11 54766-760 HUMAN PRESCRIPTION DRUG Pramosone hydrocortisone acetate and pramoxine hydrochloride CREAM TOPICAL 20150414 UNAPPROVED DRUG OTHER Sebela Pharmaceuticals Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54766-763_6063a847-17e1-7fa2-e053-2a91aa0abccc 54766-763 HUMAN PRESCRIPTION DRUG pramosone hydrocortisone acetate and pramoxine hydrochloride OINTMENT TOPICAL 20150805 UNAPPROVED DRUG OTHER Sebela Pharmaceuticals Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54766-770_638573a6-1a31-f823-e053-2a91aa0aa7ed 54766-770 HUMAN PRESCRIPTION DRUG Naftin NAFTIFINE HYDROCHLORIDE GEL TOPICAL 20180122 NDA NDA019356 Sebela Pharmaceuticals Inc. NAFTIFINE HYDROCHLORIDE 10 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20191231 54766-777_6063ad02-65bd-4b2e-e053-2991aa0af3d4 54766-777 HUMAN PRESCRIPTION DRUG Pramosone hydrocortisone acetate and pramoxine hydrochloride OINTMENT TOPICAL 20150805 UNAPPROVED DRUG OTHER Sebela Pharmaceuticals Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54766-778_6061fb5a-a9cb-1630-e053-2991aa0ac4d8 54766-778 HUMAN PRESCRIPTION DRUG Analpram HC hydrocortisone acetate and pramoxine hydrochloride CREAM TOPICAL 20150805 ANDA ANDA085368 Sebela Pharmaceuticals Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54766-799_35f8330a-aae3-13d3-e054-00144ff8d46c 54766-799 HUMAN PRESCRIPTION DRUG Analpram HC hydrocortisone acetate and pramoxine hydrochloride CREAM TOPICAL 20150807 UNAPPROVED DRUG OTHER Sebela Pharmaceuticals Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54766-829_60626863-b3aa-b92b-e053-2991aa0a8f69 54766-829 HUMAN PRESCRIPTION DRUG Analpram HC hydrocortisone acetate and pramoxine hydrochloride LOTION TOPICAL 20150805 ANDA ANDA085979 Sebela Pharmaceuticals Inc. HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 25; 10 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54766-835_6062bf80-e753-eb7b-e053-2a91aa0abf2c 54766-835 HUMAN PRESCRIPTION DRUG MiCort HC hydrocortisone acetate CREAM TOPICAL 20160913 ANDA ANDA040396 Sebela Pharmaceuticals Inc. HYDROCORTISONE ACETATE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54766-894_60293585-407c-a73b-e053-2a91aa0add6b 54766-894 HUMAN PRESCRIPTION DRUG LOTRONEX alosetron hydrochloride TABLET ORAL 20160711 NDA NDA021107 Sebela Pharmaceuticals Inc. ALOSETRON HYDROCHLORIDE .5 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 54766-895_60293585-407c-a73b-e053-2a91aa0add6b 54766-895 HUMAN PRESCRIPTION DRUG LOTRONEX alosetron hydrochloride TABLET ORAL 20160711 NDA NDA021107 Sebela Pharmaceuticals Inc. ALOSETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 54766-907_60daee5c-9352-9cd0-e053-2a91aa0a3cdf 54766-907 HUMAN PRESCRIPTION DRUG BRISDELLE paroxetine CAPSULE ORAL 20170523 NDA NDA204516 Sebela Pharmaceuticals Inc. PAROXETINE MESYLATE 7.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54767-001_b18997db-d361-4ad3-a352-2b186b00d6a3 54767-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20100914 NDA NDA205767 Shaw Oxygen Company Inc OXYGEN 995 mL/L N 20181231 54776-001_a034ea4d-bf91-4300-87ed-0f685c7cea53 54776-001 HUMAN PRESCRIPTION DRUG Heliox Heliox GAS RESPIRATORY (INHALATION) 20130101 UNAPPROVED MEDICAL GAS Spec Connection International Inc OXYGEN; HELIUM 300; 700 mL/L; mL/L E 20171231 54776-002_4619d090-d857-48e3-94aa-8bb2478e43d0 54776-002 HUMAN PRESCRIPTION DRUG Hyperbaric Chamber Mix Hyperbaric Chamber Mix GAS RESPIRATORY (INHALATION) 20130101 UNAPPROVED MEDICAL GAS Spec Connection International Inc OXYGEN; NITROGEN 500; 500 mL/L; mL/L E 20171231 54776-003_a58e5661-0d2e-4522-9caa-481bd8c1018d 54776-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture Carbon Dioxide Oxygen Mixture GAS RESPIRATORY (INHALATION) 20130101 UNAPPROVED MEDICAL GAS Spec Connection International Inc CARBON DIOXIDE; OXYGEN 200; 800 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 54776-004_6141646a-6441-c6e0-e053-2a91aa0aa236 54776-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture Carbon Dioxide Oxygen Mixture GAS RESPIRATORY (INHALATION) 20130101 NDA NDA205889 Spec Connection International Inc OXYGEN 800 mL/L N 20181231 54776-005_6141a28d-8336-8aa8-e053-2a91aa0a197e 54776-005 HUMAN PRESCRIPTION DRUG Hyperbaric Chamber Mix Hyperbaric Chamber Mix GAS RESPIRATORY (INHALATION) 20130101 NDA NDA205889 Spec Connection International Inc OXYGEN 500 mL/L N 20181231 54776-006_614182b5-5aa6-9efd-e053-2991aa0a7578 54776-006 HUMAN PRESCRIPTION DRUG Heliox Heliox GAS RESPIRATORY (INHALATION) 20130101 NDA NDA205889 Spec Connection International Inc OXYGEN 300 mL/L N 20181231 54799-431_74a29eff-aa74-89e5-5d14-48471d0e2f82 54799-431 HUMAN PRESCRIPTION DRUG HOMATROPINE HYDROBROMIDE HOMATROPINE HYDROBROMIDE OPHTHALMIC SOLUTION OPHTHALMIC 20140210 UNAPPROVED DRUG OTHER OCuSOFT, Inc. HOMATROPINE HYDROBROMIDE 50 mg/mL Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 54799-503_7cbe515b-88df-8f21-88e9-6be068b04565 54799-503 HUMAN OTC DRUG GONIOSOFT Hypromellose 2.5% LIQUID OPHTHALMIC 19891002 UNAPPROVED DRUG OTHER OCuSOFT, Inc. HYPROMELLOSES 25 mg/mL N 20181231 54799-504_2e0fd72a-c45e-473f-9419-c09d0cd74f89 54799-504 HUMAN PRESCRIPTION DRUG TetraVisc Forte Tetracaine Hydrochloride LIQUID OPHTHALMIC 20090825 UNAPPROVED DRUG OTHER OCuSOFT, INC. TETRACAINE HYDROCHLORIDE 25 mg/5mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 54799-504_a94b8262-590b-4164-b2cb-e0b074888d1b 54799-504 HUMAN PRESCRIPTION DRUG TetraVisc Forte Tetracaine Hydrochloride LIQUID OPHTHALMIC 20090825 UNAPPROVED DRUG OTHER OCuSOFT, INC. TETRACAINE HYDROCHLORIDE 3 mg/.6mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 54799-505_12cb00e5-6494-4bfe-afa3-9cf5cf6c2211 54799-505 HUMAN PRESCRIPTION DRUG TetraVisc Tetracaine Hydrochloride LIQUID OPHTHALMIC 20050802 UNAPPROVED DRUG OTHER OCuSOFT, Inc. TETRACAINE HYDROCHLORIDE 25 mg/5mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 54799-507_7f07fd14-e89d-414b-8223-2cfb6eb9d6ba 54799-507 HUMAN PRESCRIPTION DRUG FLUCAINE Fluorescein Sodium and Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19890330 UNAPPROVED DRUG OTHER OCuSOFT, Inc. FLUORESCEIN SODIUM; PROPARACAINE HYDROCHLORIDE 2.5; 5 mg/mL; mg/mL Diagnostic Dye [EPC],Dyes [MoA],Local Anesthesia [PE],Local Anesthetic [EPC] N 20181231 54799-508_5476a07b-4f5c-3b6b-38b3-b006435306c1 54799-508 HUMAN PRESCRIPTION DRUG Flurox Fluorescein Sodium 2.5mg (0.25%), Benoxinate Hydrochloride 4mg (0.4%) SOLUTION OPHTHALMIC 20140129 UNAPPROVED DRUG OTHER OCuSOFT, Inc. FLUORESCEIN SODIUM; BENOXINATE HYDROCHLORIDE 2.5; 4 mg/mL; mg/mL Diagnostic Dye [EPC],Dyes [MoA] N 20181231 54799-533_e443a044-dbb9-48b8-a4da-cfad0781509c 54799-533 HUMAN PRESCRIPTION DRUG Alodox Doxycyline Hyclate TABLET ORAL 20081001 ANDA ANDA065277 OCuSOFT INC. DOXYCYCLINE HYCLATE 20 mg/1 N 20181231 54799-535_7a80af0f-b54d-4a1f-864c-7ecda14c777b 54799-535 HUMAN PRESCRIPTION DRUG Ocudox Doxycycline Hyclate CAPSULE ORAL 20110401 ANDA ANDA062675 OCuSOFT INC. DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 54799-565_e78cfa7e-d686-086d-8447-53d434aa5ce9 54799-565 HUMAN OTC DRUG PURIFIED WATER PURIFIED WATER SOLUTION/ DROPS OPHTHALMIC 20090101 OTC MONOGRAPH FINAL part349 OCuSOFT, Inc. WATER 99.03 mL/100mL N 20181231 54799-893_9406eb57-758e-4030-80a5-5b0bd570e1ce 54799-893 HUMAN OTC DRUG retaine PM Mineral Oil, White petrolatum OINTMENT OPHTHALMIC 20130902 OTC MONOGRAPH FINAL part347 OCuSOFT, Inc. MINERAL OIL; PETROLATUM 200; 800 mg/g; mg/g N 20181231 54799-896_620ca1fc-c10a-3933-3340-36aaedd7c566 54799-896 HUMAN OTC DRUG retaine HPMC Hypromellose 2910 (4000 Mpa.s) SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20130501 OTC MONOGRAPH FINAL part349 OCuSOFT, Inc. HYPROMELLOSE 2910 (4000 MPA.S) 3 mg/mL N 20181231 54799-897_ac103906-7e9b-4582-9159-34a2cca56dad 54799-897 HUMAN OTC DRUG Retaine CMC Lubricant Eye Drops Carboxymethylcellulose Sodium SOLUTION OPHTHALMIC 20110901 OTC MONOGRAPH FINAL part349 OCuSOFT Inc. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 54799-906_39887c74-277e-dc11-d9c9-90789f65c53d 54799-906 HUMAN OTC DRUG Tears Again opht Mineral oil, White petrolatum OINTMENT OPHTHALMIC 20130901 OTC MONOGRAPH FINAL part347 OCuSOFT, Inc. MINERAL OIL; PETROLATUM 200; 800 mg/g; mg/g N 20181231 54799-917_37fa61e9-d290-2c44-e054-00144ff88e88 54799-917 HUMAN OTC DRUG retaine MGD Mineral Oil EMULSION OPHTHALMIC 20120105 OTC MONOGRAPH FINAL part349 OCuSOFT, Inc. LIGHT MINERAL OIL; MINERAL OIL 2; 2 mg/.4mL; mg/.4mL N 20181231 54799-925_2fba3378-b917-2733-9088-df73a0e63ae9 54799-925 HUMAN OTC DRUG Sochlor Sodium Chloride Hypertonicity Ophthalmic Solution 5% Solution SOLUTION/ DROPS OPHTHALMIC 20140203 OTC MONOGRAPH FINAL part349 OCuSOFT, Inc. SODIUM CHLORIDE 50 mg/mL N 20181231 54799-926_20729204-3c2e-ba74-1244-b1832e30abfd 54799-926 HUMAN OTC DRUG Sochlor Sodium Chloride Hypertonicity Ophthalmic Ointment 5% Sterile OINTMENT OPHTHALMIC 20140205 OTC MONOGRAPH FINAL part349 OCuSOFT, Inc. SODIUM CHLORIDE 50 mg/g N 20181231 54828-001_859249bf-a0c1-40fd-af5c-a831c07c1b9a 54828-001 HUMAN PRESCRIPTION DRUG Neuraceq florbetaben F 18 INJECTION, SOLUTION INTRAVENOUS 20140320 NDA NDA204677 Piramal Imaging, SA FLORBETABEN F-18 135 mCi/mL Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA] E 20171231 54829-001_8cc4150d-92c9-4382-8119-9f5755770145 54829-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20121001 UNAPPROVED MEDICAL GAS Central Oxygen Inc OXYGEN 99 L/100L E 20171231 54832-0001_ed9af751-0796-4f29-8959-268684b916cf 54832-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850815 UNAPPROVED MEDICAL GAS Heart of the Ozarks Medical Equipment OXYGEN 99 L/100L E 20171231 54838-101_838948cd-763a-42f1-8bb7-48e95a31d297 54838-101 HUMAN OTC DRUG Silafed Pseudoephedrine hydrochloride and Triprolidine hydrochloride SYRUP ORAL 19881005 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE 30; 1.25 mg/5mL; mg/5mL E 20171231 54838-104_c7da7339-b0ae-4142-8973-84661ab4ccd2 54838-104 HUMAN OTC DRUG Childrens Silfedrine Pseudoephedrine hydrochloride LIQUID ORAL 20010105 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg/5mL E 20171231 54838-105_9331ca3a-5e93-4897-a855-8fa0c07f41bf 54838-105 HUMAN OTC DRUG Silphen DM Cough Dextromethorphan Hydrobromide LIQUID ORAL 19871201 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL E 20171231 54838-107_f422390a-1793-4e38-a43b-1163205f2a47 54838-107 HUMAN OTC DRUG Silace Docusate sodium SYRUP ORAL 19900305 OTC MONOGRAPH NOT FINAL part334 Silarx Pharmaceuticals,Inc DOCUSATE SODIUM 60 mg/15mL E 20171231 54838-115_872f592b-cfb7-4e5d-9cc9-b625da8a22f4 54838-115 HUMAN OTC DRUG Pediatric Cough and Cold Medicine Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID ORAL 19970105 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 1; 15; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 54838-116_a17022ea-3918-485f-a68c-1c5549a9bb52 54838-116 HUMAN OTC DRUG Silace Docusate sodium LIQUID ORAL 19901005 OTC MONOGRAPH NOT FINAL part334 Silarx Pharmaceuticals, Inc DOCUSATE SODIUM 10 mg/mL E 20171231 54838-117_65e995d0-c415-4e7f-a6c5-6f567899f684 54838-117 HUMAN OTC DRUG Siltussin SA Guaifenesin LIQUID ORAL 19981005 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc GUAIFENESIN 100 mg/5mL E 20171231 54838-125_8408e1b1-ee76-4119-b4d1-cc2d50585121 54838-125 HUMAN OTC DRUG Brotapp Brompheniramine maleate and Pseudoephedrine hydrochloride LIQUID ORAL 20010405 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15 mg/5mL; mg/5mL E 20171231 54838-130_effcd03b-b2fa-408a-9495-3b06eba94154 54838-130 HUMAN OTC DRUG Siltussin DAS Guaifenesin LIQUID ORAL 19960201 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc GUAIFENESIN 100 mg/5mL E 20171231 54838-133_0b76921b-7f8b-432f-81ce-fd2f62556424 54838-133 HUMAN OTC DRUG Siltussin DM DAS Cough Formula Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 19950905 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL E 20171231 54838-135_d4b8cc0b-dfe3-4ee2-ae21-80a19eacc997 54838-135 HUMAN OTC DRUG Siladryl Allergy Medicine diphenhydramine hydrochloride LIQUID ORAL 19970101 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 54838-136_88e8500e-847d-4f90-a89d-432d0d342e91 54838-136 HUMAN OTC DRUG Brotapp DM Cold and Cough Brompheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID ORAL 20010405 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 1; 15; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 54838-138_b98adb86-afb9-4e95-a8a2-3a5bbb8afadb 54838-138 HUMAN OTC DRUG Diabetic Siltussin DAS-Na Guaifenesin LIQUID ORAL 20051205 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc GUAIFENESIN 100 mg/5mL E 20171231 54838-139_a3ff6462-14a9-4094-b8c6-def9eef034fd 54838-139 HUMAN OTC DRUG Diabetic Siltussin DM DAS-Na Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 20051105 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL E 20171231 54838-140_584711d9-fce3-4088-a1f6-f6bf64b8f156 54838-140 HUMAN OTC DRUG Diabetic Maximum Strength Siltussin DM DAS-Na Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 20051105 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals, Inc GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 200; 10 mg/5mL; mg/5mL E 20171231 54838-144_b8694264-a585-4994-83ec-594f2f5d1fab 54838-144 HUMAN OTC DRUG Childrens Silapap Acetaminophen LIQUID ORAL 19940905 OTC MONOGRAPH NOT FINAL part343 Silarx Pharmaceuticals, Inc ACETAMINOPHEN 160 mg/5mL E 20171231 54838-147_120836b1-4eb3-4523-8221-a38296cee866 54838-147 HUMAN OTC DRUG Brotapp PE-DM Cough and Cold Liquid Brotapp PE-DM Cough and Cold Liquid LIQUID ORAL 20010402 OTC MONOGRAPH FINAL part341 Silarx Pharmaceutical, Inc BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 1; 2.5; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 54838-154_32730640-56e1-4c59-8058-c2ef8ed64e61 54838-154 HUMAN OTC DRUG Silphen Diphenhydramine hydrochloride SYRUP ORAL 19931203 OTC MONOGRAPH FINAL part341 Silarx Pharmaceutical, Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 54838-209_0acdbd81-2461-4fe0-99fb-72727a8e83a4 54838-209 HUMAN OTC DRUG Siltussin DM Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 19920905 OTC MONOGRAPH FINAL part341 Silarx Pharmaceuticals,Inc GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL E 20171231 54838-221_7fd7dbb6-a186-4b03-90f2-f76e6f4c0c41 54838-221 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20161110 ANDA ANDA207236 Silarx Pharmaceuticals, Inc. MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 54838-222_7fd7dbb6-a186-4b03-90f2-f76e6f4c0c41 54838-222 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20161110 ANDA ANDA207236 Silarx Pharmaceuticals, Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 54838-501_29391de6-40f0-4864-9679-4fd791ec4ee0 54838-501 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol SOLUTION ORAL 20090908 ANDA ANDA073364 Silarx Pharmaceuticals, Inc. HALOPERIDOL LACTATE 2 mg/mL Typical Antipsychotic [EPC] N 20181231 54838-502_6bd92b80-fd78-4007-81bb-f0e0f178a371 54838-502 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride SOLUTION ORAL 20130821 ANDA ANDA201674 Silarx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 54838-506_82d9f048-acc5-4149-b4db-3a2c35c7e5ce 54838-506 HUMAN PRESCRIPTION DRUG Hyosyne Hyoscyamine Sulfate SOLUTION/ DROPS ORAL 19971001 UNAPPROVED DRUG OTHER Silarx Pharmaceuticals, Inc HYOSCYAMINE SULFATE .125 mg/mL E 20171231 54838-507_1feaf834-ccfd-4283-9445-d05c777461ef 54838-507 HUMAN PRESCRIPTION DRUG Metaproterenol Sulfate Metaproterenol Sulfate SYRUP ORAL 20090908 ANDA ANDA073632 Silarx Pharmaceuticals, Inc METAPROTERENOL SULFATE 10 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54838-510_a678cac0-b604-4084-872d-299ab419bc67 54838-510 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride SYRUP ORAL 20090908 ANDA ANDA074520 Silarx Pharmaceuticals, Inc OXYBUTYNIN CHLORIDE 5 mg/5mL Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54838-511_7c2a13da-2ebf-4501-b999-ab51b817df3f 54838-511 HUMAN PRESCRIPTION DRUG Hyosyne Hyoscyamine Sulfate ELIXIR ORAL 19971101 UNAPPROVED DRUG OTHER Silarx Pharmaceuticals, Inc HYOSCYAMINE SULFATE .125 mg/5mL E 20171231 54838-512_5eb348ae-d8ed-423e-a126-ac99629c69ee 54838-512 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride SOLUTION ORAL 19981229 ANDA ANDA074721 Silarx Pharmaceuticals, Inc DOXEPIN HYDROCHLORIDE 10 mg/mL Tricyclic Antidepressant [EPC] E 20171231 54838-514_cf38b2c2-9171-49e8-9fd1-1f81967c0428 54838-514 HUMAN PRESCRIPTION DRUG Clemastine Fumarate Clemastine Fumarate SYRUP ORAL 19971217 ANDA ANDA074884 Silarx Pharmaceuticals, Inc CLEMASTINE FUMARATE .5 mg/mL E 20171231 54838-522_53e33cd6-d13b-45fe-b427-57e3218a24d7 54838-522 HUMAN PRESCRIPTION DRUG CHOLINE MAGNESIUM TRISALICYLATE CHOLINE MAGNESIUM TRISALICYLATE LIQUID ORAL 19970205 UNAPPROVED DRUG OTHER Silarx Pharmaceuticals, Inc CHOLINE MAGNESIUM TRISALICYLATE 500 mg/5mL E 20171231 54838-523_5f050869-a958-46ea-83f7-4c88ffc08309 54838-523 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride LIQUID ORAL 20090827 ANDA ANDA077849 Silarx Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54838-540_31b9611b-8666-48ad-a9a1-1f2c9d0df537 54838-540 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide SOLUTION ORAL 20060614 ANDA ANDA077629 Silarx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 10 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54838-548_84e6b6f8-f54d-4c50-a200-0603f708c136 54838-548 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090403 ANDA ANDA090263 Lannett Company, Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 54838-550_e3375190-4cbb-49cb-8f7b-41bf5630afa3 54838-550 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine Hydrochloride SOLUTION ORAL 20101210 ANDA ANDA091288 Silarx Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 54838-551_c2ebc0b6-5272-414e-b4cf-e19f16241ec2 54838-551 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate SOLUTION ORAL 20130530 ANDA ANDA090477 Silarx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54838-552_cfe92867-6aed-4e8c-bd72-6693c5d05682 54838-552 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20110502 ANDA ANDA091130 Silarx Pharmaceuticals, Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL E 20171231 54838-554_7bf43d1e-5a72-4401-b8e2-8da4c5a15a0d 54838-554 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20101124 ANDA ANDA077421 Silarx Pharmaceuticals, Inc LORATADINE 5 mg/5mL E 20171231 54838-555_af26c62d-c7c7-4bb0-b3f1-1852d953498d 54838-555 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride SOLUTION ORAL 20110127 ANDA ANDA091342 Lannett Company, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 54838-556_bbe04fbf-42f6-49d2-9b7f-ee140a71e4c3 54838-556 HUMAN PRESCRIPTION DRUG Theophylline Theophylline SOLUTION ORAL 20110413 ANDA ANDA091156 Silarx Pharmaceuticals, Inc THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 54838-558_7bf43d1e-5a72-4401-b8e2-8da4c5a15a0d 54838-558 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20101124 ANDA ANDA077421 Silarx Pharmaceuticals, Inc LORATADINE 5 mg/5mL E 20171231 54838-559_cfe92867-6aed-4e8c-bd72-6693c5d05682 54838-559 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20110506 ANDA ANDA091130 Silarx Pharmaceuticals, Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL E 20171231 54838-563_4123b3d6-472d-46d5-b07f-4d1bfb36868a 54838-563 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20150130 ANDA ANDA202386 Silarx Pharmaceuticals, Inc RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] E 20171231 54838-566_2e32a1ee-930a-48cd-8f71-6926af473558 54838-566 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine SOLUTION ORAL 20140130 ANDA ANDA203564 Silarx Pharmaceuticals, Inc. LAMIVUDINE 10 mg/mL Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 54838-570_311c5093-3c8a-401f-bf58-e99580b18f08 54838-570 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole SOLUTION ORAL 20150817 ANDA ANDA204171 Silarx Pharmaceuticals, Inc. ARIPIPRAZOLE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 54838-571_a1804ef3-a9b8-45ad-860b-6798a950d2dd 54838-571 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SYRUP ORAL 20120511 ANDA ANDA078876 Silarx Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 5 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 54838-572_a1804ef3-a9b8-45ad-860b-6798a950d2dd 54838-572 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SYRUP ORAL 20120511 ANDA ANDA078876 Silarx Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 5 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 54859-001_0426888d-225e-421d-b528-4061999f1e4a 54859-001 HUMAN OTC DRUG Dologesic NF Acetaminophen, Dexbrompheniramine Maleate TABLET ORAL 20160401 OTC MONOGRAPH NOT FINAL part343 Llorens Pharmaceutical International Division ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE 500; 1 mg/1; mg/1 N 20181231 54859-010_82a47a73-d53b-4a86-a399-3bf439bf1d74 54859-010 HUMAN OTC DRUG Dologesic DF Acetaminophen, Dexbrompheniramine Maleate TABLET ORAL 20160401 OTC MONOGRAPH NOT FINAL part343 Llorens Pharmaceutical International Division ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE 500; 1 mg/1; mg/1 N 20181231 54859-120_7a7884d7-7b51-4101-ac96-d61c47346a59 54859-120 HUMAN OTC DRUG Dermagesic Pramoxine HCl, Zinc Oxide, Calamine LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part347 Llorens Pharmaceuticals International Division PRAMOXINE HYDROCHLORIDE; ZINC OXIDE; FERRIC OXIDE RED 1; .4; .4 mg/100mL; mg/100mL; mg/100mL N 20181231 54859-202_1c7321fa-9ba7-46a9-911a-45160c44acb4 54859-202 HUMAN OTC DRUG Dermagesic Pramoxine HCl, Zinc Oxide, Calamine CREAM TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part347 Llorens Pharmaceutical International Division PRAMOXINE HYDROCHLORIDE; ZINC OXIDE; FERRIC OXIDE RED 10; 4; 4 mg/g; mg/g; mg/g N 20181231 54859-502_b7b3ac0c-aac6-487e-b02f-8b58925e6b4f 54859-502 HUMAN OTC DRUG Tusnel Dextromethorphan, Guiafenesin, Pseudoephedrine HCl LIQUID ORAL 20060101 OTC MONOGRAPH FINAL part341 Llorens Pharmaceutical International Division DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 200; 30 mg/5mL; mg/5mL; mg/5mL N 20191231 54859-503_1c68493c-4a56-44f4-987b-a8800cc4b44e 54859-503 HUMAN OTC DRUG Orasep Benzocaine, Menthol, Cetylpyridinium Chloride LIQUID TOPICAL 20100401 OTC MONOGRAPH FINAL part346 Llorens Pharmaceutical International Division BENZOCAINE; MENTHOL; CETYLPYRIDINIUM CHLORIDE 2; .5; .1 mL/100mL; mL/100mL; mL/100mL N 20181231 54859-504_63c9d48b-72e1-45b2-bc93-b8961d0837dc 54859-504 HUMAN OTC DRUG Orasep Benzocaine, Menthol, Cetylpyridinium Chloride LIQUID TOPICAL 20100401 OTC MONOGRAPH FINAL part346 Llorens Pharmaceutical International Division BENZOCAINE; MENTHOL; CETYLPYRIDINIUM CHLORIDE 2; .5; .1 mL/100mL; mL/100mL; mL/100mL N 20181231 54859-505_24cab5ea-b88e-4b21-b811-229659f00467 54859-505 HUMAN OTC DRUG Tusnel Diabetic Dextromethorphan, Guaifenesin LIQUID ORAL 20031201 OTC MONOGRAPH FINAL part341 LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 54859-520_683850e3-aa56-4514-b438-6780228d3341 54859-520 HUMAN OTC DRUG Tusnel C Codeine Phosphate, Guiafenesin, Pseudoephedrine HCl LIQUID ORAL 19950101 OTC MONOGRAPH FINAL part341 Llorens Pharmaceutical International Division CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 100; 30 mg/5mL; mg/5mL; mg/5mL CV N 20181231 54859-544_ea5d9b83-4887-4680-aac0-dcc69fc29001 54859-544 HUMAN OTC DRUG Tusnel Pediatric Dextromethorphan, Guiafenesin, Pseudoephedrine HCl LIQUID ORAL 20060101 OTC MONOGRAPH FINAL part341 Llorens Pharmaceutical International Division DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 50; 15 mg/5mL; mg/5mL; mg/5mL N 20191231 54859-602_4d96e27d-d9fc-460f-bfbb-6dd7b9185251 54859-602 HUMAN OTC DRUG Tusnel Pediatric Guiafenesin, Pseudoephedrine HCl SOLUTION/ DROPS ORAL 20060101 OTC MONOGRAPH FINAL part341 Llorens Pharmaceutical International Division GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 25; 7.5 mg/mL; mg/mL N 20181231 54859-603_b9a2c7aa-d37d-4f0d-a75e-7db3c3c3d853 54859-603 HUMAN OTC DRUG Tusnel DM Pediatric Dextromethorphan, Guiafenesin, Pseudoephedrine HCl SOLUTION/ DROPS ORAL 19930101 OTC MONOGRAPH FINAL part341 Llorens Pharmaceutical International Division GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 25; 7.5; 2.5 mg/mL; mg/mL; mg/mL N 20181231 54859-701_30ac92c0-60aa-4b0f-82f0-5a17f62f3702 54859-701 HUMAN PRESCRIPTION DRUG Urin D/S Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate TABLET ORAL 19990501 UNAPPROVED DRUG OTHER Llorens Pharmaceutical International Division METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE 81.6; 40.8; 36.2; 10.8; .12 mg/1; mg/1; mg/1; mg/1; mg/1 Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] E 20171231 54859-702_4ea67627-d9ba-4dc7-9daf-fd8ef0cb9abe 54859-702 HUMAN OTC DRUG Conex Dexbrompheniramine Maleate, Pseudoephedrine HCl TABLET ORAL 20071101 OTC MONOGRAPH FINAL part341 LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 60 mg/1; mg/1 N 20181231 54859-801_ccf37bd0-cb7d-4290-81c5-0e00ba5c2800 54859-801 HUMAN OTC DRUG Tusnel Dextromethorphan HBr, Guaifenesin, Pseudoephedrine HCl TABLET ORAL 20070701 OTC MONOGRAPH FINAL part341 LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 30; 400; 60 mg/1; mg/1; mg/1 N 20181231 54859-802_81585939-78ee-4df2-8f65-429b017621c7 54859-802 HUMAN OTC DRUG Conex Dexbrompheniramine Maleate, Pseudoephedrine LIQUID ORAL 20071101 OTC MONOGRAPH FINAL part341 Llorens Pharmaceutical International Division DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 30 mg/5mL; mg/5mL N 20181231 54860-000_3a1b545a-5f4b-4b9f-93cc-e9864df08a6d 54860-000 HUMAN OTC DRUG Cotton Candy Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-006_deaaf014-6a8e-4ee3-9edf-744859e3ec17 54860-006 HUMAN OTC DRUG Fruit Punch Scented Hand Sanitizer Frozen Benzalkonium Chloride GEL TOPICAL 20140603 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-007_429bb709-80da-4c5b-9a57-fc85ceccafb8 54860-007 HUMAN OTC DRUG Berry Scented Hand Sanitizer Mickey Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .06 mg/59mg N 20181231 54860-008_704b9db9-ec9a-440b-895d-3f37d7feb80b 54860-008 HUMAN OTC DRUG Berry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-009_818c6a33-60b5-42e7-a600-90595e976be2 54860-009 HUMAN OTC DRUG Berry Scented Hand Sanitizer Minnie Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .06 mg/59mg N 20181231 54860-010_6f3e49f6-cd77-4a06-95ba-c71b35c089ee 54860-010 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-011_8bf1d60e-994a-47de-bc4a-6aa0a34c9365 54860-011 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-012_3fb0401b-556f-4cf5-8993-0d6f62903e74 54860-012 HUMAN OTC DRUG Berry Scented Hand Sanitizer Princesses Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .06 mg/59mg N 20181231 54860-013_13750e26-94ff-4f9a-b3ce-e7f896818048 54860-013 HUMAN OTC DRUG Raspberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-014_0fd4b611-e41d-4b0d-90a2-e483a8b843a0 54860-014 HUMAN OTC DRUG Fruit Punch Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-015_f3257c85-3bed-478e-8fe7-23e260864b09 54860-015 HUMAN OTC DRUG Grape Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-016_f4fb1ef4-d8c3-4be5-bb98-772f955dee4f 54860-016 HUMAN OTC DRUG Bubble Gum Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-017_b0bc3504-daf2-46c8-b520-65d479f96395 54860-017 HUMAN OTC DRUG Berry Scented Hand Sanitizer Cars Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .06 mg/59mg N 20181231 54860-018_f5cedefe-f2c9-4801-bc64-dff7bc6fa56d 54860-018 HUMAN OTC DRUG Berry Scented Hand Sanitizer Girl Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .06 mg/59mg N 20181231 54860-019_5c8b0ff2-bc84-e235-e053-2a91aa0ac8d0 54860-019 HUMAN OTC DRUG SmartCare Shopkins ethyl alcohol GEL TOPICAL 20171027 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 54860-020_2dcc6e43-00b3-6b2a-e054-00144ff8d46c 54860-020 HUMAN OTC DRUG Home Boov-el Gum Scented Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part333A SHENZHEN LANTERN SCIENCE CO., LTD BENZALKONIUM CHLORIDE 1 mg/100mg N 20181231 54860-021_2e0769a3-6eb7-0eef-e054-00144ff88e88 54860-021 HUMAN OTC DRUG Marvels Ultimate Spider Man Strawberry Scented Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20160314 OTC MONOGRAPH NOT FINAL part333A SHENZHEN LANTERN SCIENCE CO., LTD BENZALKONIUM CHLORIDE 1 mg/100mg N 20181231 54860-022_2e067f3b-9347-5c2d-e054-00144ff88e88 54860-022 HUMAN OTC DRUG Disney Frozen Strawberry Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20160314 OTC MONOGRAPH NOT FINAL part333A SHENZHEN LANTERN SCIENCE CO., LTD BENZALKONIUM CHLORIDE 1 mg/100mg N 20181231 54860-023_3349e22c-d3fc-66d5-e054-00144ff8d46c 54860-023 HUMAN OTC DRUG Strawberry Ice cream Anti-Bacterial Hand Sanitizer Alcohol 68% GEL TOPICAL 20160503 OTC MONOGRAPH NOT FINAL part333E SHENZHEN LANTERN SCIENCE CO., LTD ALCOHOL 68 mL/100mL N 20181231 54860-024_3349e22c-d3fd-66d5-e054-00144ff8d46c 54860-024 HUMAN OTC DRUG Vanilla Ice cream Anti-Bacterial Hand Sanitizer Alcohol 68% GEL TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part333E SHENZHEN LANTERN SCIENCE CO., LTD ALCOHOL 68 mL/100mL N 20181231 54860-025_334a18f6-6921-6ed0-e054-00144ff8d46c 54860-025 HUMAN OTC DRUG Blueberry cream Anti-Bacterial Hand Sanitizer Alcohol 68% GEL TOPICAL 20160503 OTC MONOGRAPH NOT FINAL part333E SHENZHEN LANTERN SCIENCE CO., LTD ALCOHOL 68 mL/100mL N 20181231 54860-026_330c55b5-4814-5333-e054-00144ff8d46c 54860-026 HUMAN OTC DRUG Shopkins 3D Hand Sanitizer DLish Donut ethyl alcohol GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333E SHENZHEN LANTERN SCIENCE CO., LTD ALCOHOL 62 g/100g N 20181231 54860-027_330e5fd5-2be5-447e-e054-00144ff88e88 54860-027 HUMAN OTC DRUG Shopkins 3D Hand Sanitizer Lippy Lips ethyl alcohol GEL TOPICAL 20160517 OTC MONOGRAPH NOT FINAL part333E SHENZHEN LANTERN SCIENCE CO., LTD ALCOHOL 62 g/100g N 20181231 54860-028_334a3704-d096-0a85-e054-00144ff8d46c 54860-028 HUMAN OTC DRUG Strawberry Ice cream Anti-Bacterial Hand Sanitizer Alcohol 68% GEL TOPICAL 20160503 OTC MONOGRAPH NOT FINAL part333E SHENZHEN LANTERN SCIENCE CO., LTD ALCOHOL 68 mL/100mL N 20181231 54860-029_334ba321-81c4-7025-e054-00144ff88e88 54860-029 HUMAN OTC DRUG Vanilla Ice cream Anti-Bacterial Hand Sanitizer Alcohol 68% GEL TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part333E SHENZHEN LANTERN SCIENCE CO., LTD ALCOHOL 68 mL/100mL N 20181231 54860-030_334c69ed-5cc1-0e72-e054-00144ff8d46c 54860-030 HUMAN OTC DRUG Blueberry cream Anti-Bacterial Hand Sanitizer Alcohol 68% GEL TOPICAL 20160503 OTC MONOGRAPH NOT FINAL part333E SHENZHEN LANTERN SCIENCE CO., LTD ALCOHOL 68 mL/100mL N 20181231 54860-031_34c971de-071e-0309-e054-00144ff8d46c 54860-031 HUMAN OTC DRUG Kung Fu Panda Hand Sanitizer Chloroxylenol GEL TOPICAL 20160608 OTC MONOGRAPH NOT FINAL part333E shenzhen Lantern Science Co. Ltd. CHLOROXYLENOL .05 g/59g N 20181231 54860-032_352fc8ca-fe07-5b74-e054-00144ff88e88 54860-032 HUMAN OTC DRUG Frozen Watermelon Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160608 OTC MONOGRAPH NOT FINAL part333E shenzhen Lantern Science Co. Ltd. BENZALKONIUM CHLORIDE .01 g/59g N 20181231 54860-033_3530f86f-33af-1d07-e054-00144ff8d46c 54860-033 HUMAN OTC DRUG Frozen Bubble Gum Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160608 OTC MONOGRAPH NOT FINAL part333E shenzhen Lantern Science Co. Ltd. BENZALKONIUM CHLORIDE .01 g/59g N 20181231 54860-034_35313193-6f0f-1ac2-e054-00144ff88e88 54860-034 HUMAN OTC DRUG Frozen Grape Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160613 OTC MONOGRAPH NOT FINAL part333E shenzhen Lantern Science Co. Ltd. BENZALKONIUM CHLORIDE .01 g/59g N 20181231 54860-035_356c1a3f-b3e9-4d20-e054-00144ff88e88 54860-035 HUMAN OTC DRUG Emoji Watermelon Scented Hand Sanitizer Heart Eyes Benzalkonium Chloride GEL TOPICAL 20160616 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-036_356c191a-34d0-43c1-e054-00144ff8d46c 54860-036 HUMAN OTC DRUG Mixed Berry Scented Hand Sanitizer Emoji Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-037_356c8793-61b9-5bff-e054-00144ff88e88 54860-037 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Emoji Smile Tongue Benzalkonium Chloride GEL TOPICAL 20160616 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-038_356ce060-b7f7-03f0-e054-00144ff8d46c 54860-038 HUMAN OTC DRUG Strawberry Scented Hand Sanitizer Emoji-Crown Benzalkonium Chloride GEL TOPICAL 20160616 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-039_39be2398-e4d2-4242-e054-00144ff88e88 54860-039 HUMAN OTC DRUG Avengers Marvel Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-040_3ebeb4f2-b88b-478b-e054-00144ff88e88 54860-040 HUMAN OTC DRUG Shopkins 3D Hand Sanitizer 6 pack Ethyl Alcohol 62% GEL TOPICAL 20160812 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd ALCOHOL 62 g/59g N 20181231 54860-041_3a4a5f84-24cb-318b-e054-00144ff88e88 54860-041 HUMAN OTC DRUG Disney Mini Apple Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-042_3a4b2733-819b-485a-e054-00144ff88e88 54860-042 HUMAN OTC DRUG Disney 6 pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-043_3a4a4a2b-63eb-06cb-e054-00144ff8d46c 54860-043 HUMAN OTC DRUG Trolls 4 PackHand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-044_3a4b6ad7-89c9-4d92-e054-00144ff88e88 54860-044 HUMAN OTC DRUG Trolls 6 Pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-045_3a4ba253-2f1e-558f-e054-00144ff8d46c 54860-045 HUMAN OTC DRUG Trolls Cotton Candy Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-046_3a4bfaff-0d8f-6107-e054-00144ff88e88 54860-046 HUMAN OTC DRUG Emoji 4 pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-047_3a5abb81-788d-09b1-e054-00144ff88e88 54860-047 HUMAN OTC DRUG Disney Frozen Fruit Punch Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-048_3a5a5bb7-a35f-5268-e054-00144ff8d46c 54860-048 HUMAN OTC DRUG Disney Frozen Strawberry Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-049_3a4a29f2-e6de-2a88-e054-00144ff88e88 54860-049 HUMAN OTC DRUG Avengers Marvel 6 pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-050_3a5b2b9b-c1b7-09c1-e054-00144ff8d46c 54860-050 HUMAN OTC DRUG Disney Berry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-051_3a5bb9ce-53a4-2891-e054-00144ff88e88 54860-051 HUMAN OTC DRUG Disney Princess Strawberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-052_3a5c38ac-60bc-38a0-e054-00144ff88e88 54860-052 HUMAN OTC DRUG The Lion Gurad Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-053_3a5cdb1a-483a-6446-e054-00144ff8d46c 54860-053 HUMAN OTC DRUG The secret Life of pets Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-054_3a5bc642-167a-2a0f-e054-00144ff88e88 54860-054 HUMAN OTC DRUG Disney Princess 6 pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-055_3c644e9d-1d36-3877-e054-00144ff8d46c 54860-055 HUMAN OTC DRUG Emoji 6pk Sanitizer Benzalkonium Chloride GEL TOPICAL 20160913 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-056_3c51c9f7-652e-6225-e054-00144ff8d46c 54860-056 HUMAN OTC DRUG Avengers 2 pack Marvel Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160912 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-057_3c518a63-d396-3b29-e054-00144ff88e88 54860-057 HUMAN OTC DRUG Trolls 2 Pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160912 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-058_3c51f7a3-30f4-4c9a-e054-00144ff88e88 54860-058 HUMAN OTC DRUG Nightmare Xmas Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160912 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-059_3c51f7a3-30ff-4c9a-e054-00144ff88e88 54860-059 HUMAN OTC DRUG Nightmare Xmas Blackberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160912 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-060_3e48f619-ad4c-18a0-e054-00144ff88e88 54860-060 HUMAN OTC DRUG Frozen Fruit Punch Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20161007 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-061_3e494a06-5d24-0e57-e054-00144ff8d46c 54860-061 HUMAN OTC DRUG Comics Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20161007 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-062_3e49f7ce-c73c-364b-e054-00144ff88e88 54860-062 HUMAN OTC DRUG Spiderman Cherry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20161007 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 54860-063_464b7e46-a3bf-18f4-e054-00144ff8d46c 54860-063 HUMAN OTC DRUG Bubble Gum Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59mL N 20181231 54860-064_464ba0f5-292d-44ff-e054-00144ff8d46c 54860-064 HUMAN OTC DRUG Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59mL N 20181231 54860-065_465f7bf4-7961-05a5-e054-00144ff8d46c 54860-065 HUMAN OTC DRUG Emoji Blueberry Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 54860-066_465fe42f-c8b6-668f-e054-00144ff88e88 54860-066 HUMAN OTC DRUG Emoji Strawberry Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 54860-067_4660686c-d363-225d-e054-00144ff8d46c 54860-067 HUMAN OTC DRUG Emoji Mixed Berry Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 54860-068_4660686c-d369-225d-e054-00144ff8d46c 54860-068 HUMAN OTC DRUG Emoji Watermelon Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 54860-069_466078d0-f554-2c07-e054-00144ff8d46c 54860-069 HUMAN OTC DRUG Hulk Grape Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 54860-070_4660dacb-6dc0-1137-e054-00144ff88e88 54860-070 HUMAN OTC DRUG Captain America Blueberry Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 54860-071_4660e731-296e-1332-e054-00144ff88e88 54860-071 HUMAN OTC DRUG Iron Man Fruit Punch Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 54860-072_4661070c-d932-5086-e054-00144ff8d46c 54860-072 HUMAN OTC DRUG Spiderman Watermelon Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 54860-073_464cb0e8-4eba-098a-e054-00144ff8d46c 54860-073 HUMAN OTC DRUG Cotton Candy Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59mL N 20181231 54860-074_464c7a31-6cd5-22d9-e054-00144ff88e88 54860-074 HUMAN OTC DRUG Watermelon Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59mL N 20181231 54860-075_464c0e8d-08b7-0f3e-e054-00144ff88e88 54860-075 HUMAN OTC DRUG Raspberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59mL N 20181231 54860-076_46754c30-f202-420d-e054-00144ff8d46c 54860-076 HUMAN OTC DRUG Out of This Swirled Hand sanitizer Benzalkonium Chloride GEL TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/30mL N 20181231 54860-077_464d35f0-5afe-3e56-e054-00144ff88e88 54860-077 HUMAN OTC DRUG Donut Panic Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59mL N 20181231 54860-078_46757b51-2a38-0fe5-e054-00144ff88e88 54860-078 HUMAN OTC DRUG Flavor party Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59mL N 20181231 54860-079_46757b51-2a46-0fe5-e054-00144ff88e88 54860-079 HUMAN OTC DRUG Fruit Fight Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/59mL N 20181231 54860-080_4b461328-107a-15a1-e054-00144ff8d46c 54860-080 HUMAN OTC DRUG Vanilla Germ Killa Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/30mL N 20181231 54860-081_4b67b6e8-78f0-073b-e054-00144ff8d46c 54860-081 HUMAN OTC DRUG Berry Fresh Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170323 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/30mL N 20181231 54860-082_4df22926-a960-05e3-e054-00144ff8d46c 54860-082 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170424 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/30mL N 20181231 54860-084_53fc327e-e349-26f2-e054-00144ff8d46c 54860-084 HUMAN OTC DRUG My little Pony Hand Sanitizer 6 pack Benzalkonium Chloride GEL TOPICAL 20170710 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/22mL N 20181231 54860-086_54c3fb78-9298-4044-e054-00144ff88e88 54860-086 HUMAN OTC DRUG Emoji 6 pack Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE 1 g/30mL N 20181231 54860-088_6490536e-0e7b-8d5c-e053-2a91aa0a6c3f 54860-088 HUMAN OTC DRUG Raspberry Apple Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20180130 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100mL N 20191231 54860-089_64914c6a-aea4-3c30-e053-2a91aa0a88b0 54860-089 HUMAN OTC DRUG Vanilla Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20180130 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100mL N 20191231 54860-090_64920911-ee67-3973-e053-2a91aa0a5343 54860-090 HUMAN OTC DRUG Cherry Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20180130 OTC MONOGRAPH NOT FINAL part333E Shenzhen Lantern Science Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100mL N 20191231 54866-000_e9899fa4-a6c6-464f-9441-3b29af9a9fa2 54866-000 HUMAN OTC DRUG REVITEALIZE ANTI DANDRUFF SALICYLIC ACID SHAMPOO TOPICAL 20111201 OTC MONOGRAPH FINAL part358H Camellix, LLC SALICYLIC ACID 18 mg/mL E 20171231 54866-000_ef30d24a-5c15-4e78-8c7b-d389cd0ea5ac 54866-000 HUMAN OTC DRUG REVITEALIZE ANTI DANDRUFF SALICYLIC ACID SHAMPOO TOPICAL 20111201 OTC MONOGRAPH FINAL part358H Camellix, LLC SALICYLIC ACID 18 mg/mL E 20171231 54866-001_274fa9e5-6f94-4ac3-b952-0a7fdeebad45 54866-001 HUMAN OTC DRUG AVERTEAX zinc oxide and Cocoa Butter CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Camellix, LLC ZINC OXIDE; COCOA BUTTER .15; 2.5 mg/g; mg/g E 20171231 54866-002_dea0cd6a-9743-4539-a694-c88cf3543525 54866-002 HUMAN OTC DRUG AVERTEAX Benzyl Alcohol CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Camellix, LLC BENZYL ALCOHOL 10 mg/g E 20171231 54866-003_0c133233-1646-4889-a4ec-a3c86c03e402 54866-003 HUMAN OTC DRUG AVERTEAX zinc oxide and Cocoa Butter OINTMENT TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Camellix, LLC ZINC OXIDE; COCOA BUTTER .15; 2.5 mg/g; mg/g E 20171231 54866-321_792f3dec-457b-45f5-a101-08fce9dcf805 54866-321 HUMAN OTC DRUG PROTECTEAV ALCOHOL GEL TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part333A Camellix, LLC ALCOHOL 70 mg/100mL E 20171231 54868-0010_0fe6a5d3-1541-4a87-8289-7f24907aa588 54868-0010 HUMAN OTC DRUG Citrate of Magnesium Citrate of Magnesium LIQUID ORAL 20030129 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. MAGNESIUM CITRATE 1.745 g/29.6mL E 20171231 54868-0016_6dee501e-2e58-4ff2-901b-8f8693c776b7 54868-0016 HUMAN OTC DRUG Dulcolax bisacodyl TABLET, COATED ORAL 20100519 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. BISACODYL 5 mg/1 E 20171231 54868-0017_5f3d6306-fa1b-4280-9b1f-fd6f9cedc97c 54868-0017 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090512 NDA NDA020381 Physicians Total Care, Inc. NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 54868-0018_34ac3461-e6e3-4b5d-9c40-895dc9ca2d73 54868-0018 HUMAN PRESCRIPTION DRUG Erythromycin Ethylsuccinate erythromycin ethylsuccinate TABLET ORAL 19960227 ANDA ANDA061904 Physicians Total Care, Inc. ERYTHROMYCIN ETHYLSUCCINATE 400 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-0021_6d47c815-1af7-4a96-9daf-e1a63050cea4 54868-0021 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19950811 ANDA ANDA090624 Physicians Total Care, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 54868-0023_77fd8181-dd74-490f-9eab-e6c47573309b 54868-0023 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19930611 ANDA ANDA062031 Physicians Total Care, Inc. DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 54868-0024_f782fb03-7dd0-4c98-b037-94e15910ecb8 54868-0024 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 19880301 ANDA ANDA060704 Physicians Total Care, Inc. TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 54868-0025_f782fb03-7dd0-4c98-b037-94e15910ecb8 54868-0025 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 19961009 ANDA ANDA060704 Physicians Total Care, Inc. TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 54868-0026_c386e74e-03a0-499f-89c2-5e1b01b5ca52 54868-0026 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 54868-0028_274059ad-0c68-4ec2-ab55-5f5f48a1c380 54868-0028 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19961219 ANDA ANDA089808 Physicians Total Care, Inc. THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 54868-0029_274059ad-0c68-4ec2-ab55-5f5f48a1c380 54868-0029 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20070917 ANDA ANDA089763 Physicians Total Care, Inc. THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 54868-0032_d29439a8-a95f-4d56-88e0-c1c623e2d0c4 54868-0032 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 19950127 ANDA ANDA085762 Physicians Total Care, Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV E 20171231 54868-0033_d045ba57-e502-40e2-b179-2724dd6cd58e 54868-0033 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19951026 ANDA ANDA084285 Physicians Total Care, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 54868-0034_6e41e4ed-c643-4924-bf9b-53ebd931b2a0 54868-0034 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20030501 ANDA ANDA078807 Physicians Total Care, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 54868-0038_7a6aaf89-a634-4ca0-a555-98e2ee813032 54868-0038 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20080110 ANDA ANDA070920 Physicians Total Care, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-0039_7a6aaf89-a634-4ca0-a555-98e2ee813032 54868-0039 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20050111 ANDA ANDA070920 Physicians Total Care, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-0048_ab1f78ab-63fe-4995-b0a9-77e0e9987fc3 54868-0048 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20011003 ANDA ANDA070925 Physicians Total Care, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54868-0049_ab1f78ab-63fe-4995-b0a9-77e0e9987fc3 54868-0049 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950109 ANDA ANDA070924 Physicians Total Care, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54868-0050_8d8a30ce-654a-47f5-be45-263d691c8e22 54868-0050 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 19950829 ANDA ANDA070098 Physicians Total Care, Inc. METHYLDOPA 250 mg/1 E 20171231 54868-0052_94674abb-9b63-4684-8e32-567c07e13cbb 54868-0052 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20030227 ANDA ANDA078955 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-0053_94674abb-9b63-4684-8e32-567c07e13cbb 54868-0053 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19961209 ANDA ANDA078955 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-0054_a0734292-7217-425b-98a3-acb7e8f2d429 54868-0054 HUMAN PRESCRIPTION DRUG GoLYTELY PEG-3350 and electrolytes POWDER, FOR SOLUTION NASOGASTRIC; ORAL 20070904 NDA NDA019011 Physicians Total Care, Inc. POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 236; 22.74; 6.74; 5.86; 2.97 g/2L; g/2L; g/2L; g/2L; g/2L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-0055_da88fa99-63c7-4348-b893-00302c93e12b 54868-0055 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20000821 ANDA ANDA077002 Physicians Total Care, Inc. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 54868-0056_80fd7466-afa0-41c5-ab2d-05315b348aa6 54868-0056 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19920922 ANDA ANDA083177 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-0057_d6595eb0-875e-4ae3-baa4-e4b955eb272c 54868-0057 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20021120 ANDA ANDA078010 Physicians Total Care, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 54868-0058_d6595eb0-875e-4ae3-baa4-e4b955eb272c 54868-0058 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19990104 ANDA ANDA078010 Physicians Total Care, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 54868-0059_0fea6c8b-9c2a-4ade-8b07-bc88e081a2fd 54868-0059 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20080819 ANDA ANDA071321 Physicians Total Care, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-0061_7c5b3625-4922-4296-b34b-5336b0ca2099 54868-0061 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19951220 ANDA ANDA072928 Physicians Total Care, Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-0062_21a83a08-cb04-448b-9897-83ec9538c9c2 54868-0062 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19960424 ANDA ANDA071437 Physicians Total Care, Inc. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-0063_2c1543b0-c533-48b8-8620-0bebe302bf55 54868-0063 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 19940404 ANDA ANDA040804 Physicians Total Care, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 54868-0064_8426db88-8646-4230-9026-5a04c939621c 54868-0064 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19960618 ANDA ANDA085969 Physicians Total Care, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-0065_8426db88-8646-4230-9026-5a04c939621c 54868-0065 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19951107 ANDA ANDA085966 Physicians Total Care, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-0066_8426db88-8646-4230-9026-5a04c939621c 54868-0066 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19941004 ANDA ANDA085968 Physicians Total Care, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-0070_8cae852f-c80a-4a53-b263-537fb9e59f59 54868-0070 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19941209 ANDA ANDA083116 Physicians Total Care, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-0072_9a8448b0-90a2-4e37-b72c-4a3788b83b73 54868-0072 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20030925 ANDA ANDA040419 Physicians Total Care, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 54868-0074_4ce2b8a7-5adb-4a07-8886-7e8ab0b7125c 54868-0074 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20040802 NDA NDA018858 Physicians Total Care, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-0075_4ec9fe72-03fd-418e-8b96-f0ba2bdf4004 54868-0075 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20020510 NDA NDA018832 Physicians Total Care, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 54868-0076_4ec9fe72-03fd-418e-8b96-f0ba2bdf4004 54868-0076 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19970117 NDA NDA018877 Physicians Total Care, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 54868-0077_3bbc3f5c-6e8f-40ac-b134-63c722ea4afc 54868-0077 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 19920813 ANDA ANDA087128 Physicians Total Care, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 54868-0079_9c261d95-a90f-4a51-a2df-852f1bb0f940 54868-0079 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 19970220 ANDA ANDA078558 Physicians Total Care, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-0080_9c261d95-a90f-4a51-a2df-852f1bb0f940 54868-0080 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 19970508 ANDA ANDA078558 Physicians Total Care, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-0087_fe987ca0-9dec-45f5-9afc-fc2e2a3caf39 54868-0087 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20080125 ANDA ANDA040526 Physicians Total Care, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 54868-0089_3bbc3f5c-6e8f-40ac-b134-63c722ea4afc 54868-0089 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 19940705 ANDA ANDA087127 Physicians Total Care, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 54868-0091_b525c891-0d0c-4063-b4a4-542b92d12bd8 54868-0091 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19950726 ANDA ANDA070278 Physicians Total Care, Inc. HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] E 20171231 54868-0092_889c93be-8a08-4704-9434-96cd6606b136 54868-0092 HUMAN PRESCRIPTION DRUG Flurazepam Hydrochloride flurazepam hydrochloride CAPSULE ORAL 19950508 ANDA ANDA070345 Physicians Total Care, Inc. FLURAZEPAM HYDROCHLORIDE 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-0097_9abf3c4f-1c7f-4196-9c54-0d7e1158c901 54868-0097 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19961001 NDA NDA019123 Physicians Total Care, Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-0106_887b9788-8ac1-4e6e-9b2e-8c0e79dcd023 54868-0106 HUMAN PRESCRIPTION DRUG COREGCR CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20080825 NDA NDA022012 Physicians Total Care, Inc. CARVEDILOL PHOSPHATE 20 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 54868-0107_ea43eb69-ac9b-49ad-a88b-ad3ceb51864a 54868-0107 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20030813 ANDA ANDA073671 Physicians Total Care, Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 54868-0108_a30b6cba-3acf-46d5-92e6-74d3d787e3da 54868-0108 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19961017 NDA NDA018764 Physicians Total Care, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 54868-0109_3af42a6e-4178-482c-9e96-647e289d325a 54868-0109 HUMAN PRESCRIPTION DRUG MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate TABLET ORAL 19940706 NDA AUTHORIZED GENERIC NDA011839 Physicians Total Care, Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-0113_3a858a9c-77ae-4466-b31c-fff11fa7d469 54868-0113 HUMAN OTC DRUG Diphenhydramine Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20080423 OTC MONOGRAPH NOT FINAL part348 Physicians Total Care, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g E 20171231 54868-0116_7c5a4d20-a43d-4bc0-8d56-e75bcc2dad14 54868-0116 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION INTRAVENOUS 20080929 NDA NDA018800 Physicians Total Care, Inc. SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-0117_a112d642-fac0-4857-8d63-6e21e46c2b6d 54868-0117 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20080423 NDA NDA022145 Physicians Total Care, Inc. RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] E 20171231 54868-0120_9744dbae-6f6d-4103-80f0-84d6735c6abb 54868-0120 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19950424 ANDA ANDA070995 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-0121_9744dbae-6f6d-4103-80f0-84d6735c6abb 54868-0121 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19960205 ANDA ANDA070994 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-0122_a03d104e-6b42-4cfc-9e80-ec379c40057b 54868-0122 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19960409 ANDA ANDA071523 Physicians Total Care, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 54868-0127_51f8a9fc-6ab7-4629-bfda-7709964f4bfe 54868-0127 HUMAN OTC DRUG Castellani Paint Phenol LIQUID TOPICAL 20080515 OTC MONOGRAPH NOT FINAL part333A Physicians Total Care, Inc. PHENOL 15 mg/mL E 20171231 54868-0133_9c261d95-a90f-4a51-a2df-852f1bb0f940 54868-0133 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 19941220 ANDA ANDA078558 Physicians Total Care, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-0147_b0faccb6-dd69-4b6d-9b67-5bc4865ee711 54868-0147 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19930923 ANDA ANDA070541 Physicians Total Care, Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 54868-0153_36f7a0ae-cb8a-47e6-8719-00213e134e86 54868-0153 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20061030 ANDA ANDA065253 Physicians Total Care, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-0154_36f7a0ae-cb8a-47e6-8719-00213e134e86 54868-0154 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20041209 ANDA ANDA065253 Physicians Total Care, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-0158_a30b6cba-3acf-46d5-92e6-74d3d787e3da 54868-0158 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19950424 NDA NDA018764 Physicians Total Care, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 54868-0159_69b9bc5e-df13-4736-966a-cc9932aab38e 54868-0159 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 19950328 ANDA ANDA084442 Physicians Total Care, Inc. PROBENECID 500 mg/1 E 20171231 54868-0162_0825579e-56f9-4c3a-8c17-3a60abdc225d 54868-0162 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20050714 ANDA ANDA076258 Physicians Total Care, Inc. FENTANYL 2.55 mg/[USP'U] Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-0173_d0797250-63e3-42ba-8dc3-e3156f2c274f 54868-0173 HUMAN PRESCRIPTION DRUG METHOTREXATE methotrexate INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20030326 ANDA ANDA089343 Physicians Total Care, Inc. METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 54868-0191_77fd8181-dd74-490f-9eab-e6c47573309b 54868-0191 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19940324 ANDA ANDA062421 Physicians Total Care, Inc. DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 54868-0192_aede782b-4b92-4900-9213-758c1e6a15af 54868-0192 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE ORAL 19950201 ANDA ANDA087022 Physicians Total Care, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 54868-0216_b3e75380-e62d-40f8-8090-38753fca696f 54868-0216 HUMAN PRESCRIPTION DRUG Depo-Testosterone testosterone cypionate INJECTION, SOLUTION INTRAMUSCULAR 19940712 ANDA ANDA085635 Physicians Total Care, Inc. TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 54868-0218_537cd838-05f2-44f4-aeb2-89c42f153e3c 54868-0218 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19940119 ANDA ANDA084612 Physicians Total Care, Inc DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0229_2c1543b0-c533-48b8-8620-0bebe302bf55 54868-0229 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 19940728 ANDA ANDA040804 Physicians Total Care, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 54868-0234_13e4164c-eef8-4ef6-8f89-691e9efacdc3 54868-0234 HUMAN PRESCRIPTION DRUG Kenalog-10 triamcinolone acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL 20000502 NDA NDA012041 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0235_af81170f-fbde-43ad-889d-c7c7c24783b2 54868-0235 HUMAN PRESCRIPTION DRUG Kenalog-40 triamcinolone acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 19960611 NDA NDA014901 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0242_de53fe32-2a8e-4dd7-bea1-e29b502d8ba8 54868-0242 HUMAN PRESCRIPTION DRUG NYSTATIN Nystatin CREAM TOPICAL 19950131 ANDA ANDA064022 Physicians Total Care, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 54868-0243_6a6f2f48-f360-4f4d-a59a-22c77cd6a678 54868-0243 HUMAN PRESCRIPTION DRUG NYSTATIN nystatin SUSPENSION ORAL 19940328 ANDA ANDA062512 Physicians Total Care, Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 54868-0244_0825579e-56f9-4c3a-8c17-3a60abdc225d 54868-0244 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20050714 ANDA ANDA076258 Physicians Total Care, Inc. FENTANYL 5.1 mg/[USP'U] Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-0252_e44b17ca-493d-4510-9e52-0a1f4cb2125e 54868-0252 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate phendimetrazine tartrate TABLET ORAL 20070620 ANDA ANDA089452 Physicians Total Care, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII E 20171231 54868-0258_ac265bcb-510d-41b1-bf47-8eeac3bbbd66 54868-0258 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20020312 ANDA ANDA080352 Physicians Total Care, Inc. PREDNISONE 5 mg/1 E 20171231 54868-0262_90e5ed74-01f2-40ab-b075-798abede1e26 54868-0262 HUMAN PRESCRIPTION DRUG Promethazine promethazine hydrochloride INJECTION INTRAMUSCULAR 20020822 ANDA ANDA040454 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-0263_a19221d2-cd69-4e79-890e-43e063b2e1c5 54868-0263 HUMAN PRESCRIPTION DRUG Promethazine VC With Codeine Codeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride SYRUP ORAL 19990301 ANDA ANDA040660 Physicians Total Care, Inc. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 10; 6.25; 5 mg/5mL; mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CV E 20171231 54868-0267_ed20f459-3294-4acc-b50f-9928ff55e743 54868-0267 HUMAN PRESCRIPTION DRUG Retin-A tretinoin CREAM TOPICAL 19960101 NDA NDA017522 Physicians Total Care, Inc. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-0268_ed20f459-3294-4acc-b50f-9928ff55e743 54868-0268 HUMAN PRESCRIPTION DRUG Retin-A tretinoin CREAM TOPICAL 19960821 NDA NDA017340 Physicians Total Care, Inc. TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-0269_ed20f459-3294-4acc-b50f-9928ff55e743 54868-0269 HUMAN PRESCRIPTION DRUG Retin-A tretinoin GEL TOPICAL 19930525 NDA NDA017955 Physicians Total Care, Inc. TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-0270_ed20f459-3294-4acc-b50f-9928ff55e743 54868-0270 HUMAN PRESCRIPTION DRUG Retin-A tretinoin GEL TOPICAL 19930525 NDA NDA017579 Physicians Total Care, Inc. TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-0276_f79e0fd0-216f-4cf7-acca-be727c80bd05 54868-0276 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19971229 ANDA ANDA074650 Physicians Total Care, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 54868-0283_c97fdea4-5416-4927-83f6-48148a002330 54868-0283 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE ORAL 19970428 ANDA ANDA040886 Physicians Total Care, inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 54868-0286_6568a3ac-3b37-40e6-9ac7-94533a6fee51 54868-0286 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, CHEWABLE ORAL 20070813 ANDA ANDA065161 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 54868-0287_0825579e-56f9-4c3a-8c17-3a60abdc225d 54868-0287 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20050714 ANDA ANDA076258 Physicians Total Care, Inc. FENTANYL 7.65 mg/[USP'U] Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-0293_94674abb-9b63-4684-8e32-567c07e13cbb 54868-0293 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19930727 ANDA ANDA078955 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-0295_75cb36a3-9746-4e3a-88ad-d37d64354c51 54868-0295 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364 Physicians Total Care, Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0296_4475eb8d-f9d7-4703-a460-a3ad3855e942 54868-0296 HUMAN PRESCRIPTION DRUG Dextrose Dextrose INJECTION, SOLUTION INTRAVENOUS 20061212 NDA NDA016367 Physicians Total Care, Inc. DEXTROSE MONOHYDRATE 5 g/100mL E 20171231 54868-0325_c239fe20-4f79-4610-8e05-e6e0f52c509d 54868-0325 HUMAN PRESCRIPTION DRUG Dilantin phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 19950127 ANDA ANDA084349 Physicians Total Care, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 54868-0337_3dba3387-f213-464d-b75d-29eeacbd888c 54868-0337 HUMAN PRESCRIPTION DRUG Bactrim DS sulfamethoxazole and trimethoprim TABLET ORAL 19970826 NDA NDA017377 Physicians Total Care, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 54868-0375_44d2c2bc-d8d7-4581-bbbf-065d06aadabd 54868-0375 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine silver sulfadiazine CREAM TOPICAL 19930520 NDA NDA018578 Physicians Total Care, Inc. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 54868-0378_92aacaba-3989-4141-8e59-8109af6bfac6 54868-0378 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 20041019 ANDA ANDA087508 Physicians Total Care, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL CV E 20171231 54868-0387_3f3f31ef-a7c3-4735-8845-79a5b8a5ed85 54868-0387 HUMAN PRESCRIPTION DRUG Augmentin amoxicillin and clavulante potassium TABLET, FILM COATED ORAL 19961107 NDA NDA050564 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 54868-0427_3a69020d-7cb5-4dd9-ba44-6ef8d605cd8c 54868-0427 HUMAN PRESCRIPTION DRUG Lomotil Diphenoxylate Hydrochloride TABLET ORAL 20090119 NDA NDA012462 Physicians Total Care, Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV E 20171231 54868-0431_bb001c15-9f5c-454e-b12d-e8664b16f80b 54868-0431 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide CREAM TOPICAL 19931208 ANDA ANDA072488 Physicians Total Care, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0451_89977ac0-499f-427b-9c6f-3600f6ac5319 54868-0451 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20050208 NDA NDA004782 Physicians Total Care, Inc. ESTROGENS, CONJUGATED .625 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] E 20171231 54868-0473_ea43eb69-ac9b-49ad-a88b-ad3ceb51864a 54868-0473 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20000301 ANDA ANDA073652 Physicians Total Care, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 54868-0520_ce005228-bed3-4940-831b-c7f8b8256d9f 54868-0520 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate CREAM TOPICAL 19951016 ANDA ANDA018861 Physicians Total Care, Inc. BETAMETHASONE VALERATE 1 mg/g E 20171231 54868-0536_b5f46d0d-6971-4954-96ca-01bd0faa52eb 54868-0536 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070410 ANDA ANDA086242 Physicians Total Care, Inc. HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 54868-0538_e5925c6f-04bc-4d69-9fd4-7a122bdd6edd 54868-0538 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin SUSPENSION ORAL 19941209 ANDA ANDA065081 Physicians Total Care, Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-0548_afda5f51-4b06-44ef-b730-be5a86ffb097 54868-0548 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20021024 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ACETAMINOPHEN 325 mg/1 E 20171231 54868-0564_798c6ae0-0d1b-49ee-a9dd-8b652c5e031d 54868-0564 HUMAN PRESCRIPTION DRUG Cortisporin-TC colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone acetate SUSPENSION AURICULAR (OTIC) 20070507 NDA NDA050356 Physicians Total Care, Inc. COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE 3; 3.3; .5; 10 mg/mL; mg/mL; mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0586_086dda45-8f22-478c-8724-4c97b87499fe 54868-0586 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20090721 ANDA ANDA085159 Physicians Total Care, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 54868-0590_253084ff-74c6-4787-95af-3fa119dca417 54868-0590 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 20120726 ANDA ANDA040557 Physicians Total Care, Inc. METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0601_0da34cd6-c336-4f3c-b29f-06a1eaae90ac 54868-0601 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20030218 ANDA ANDA040603 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-0610_3d863f8d-dac2-429c-8dc3-00763b41f1e0 54868-0610 HUMAN PRESCRIPTION DRUG Colestipol Hydrochloride colestipol hydrochloride TABLET ORAL 20070228 NDA AUTHORIZED GENERIC NDA020222 Physicians Total Care, Inc. COLESTIPOL HYDROCHLORIDE 1 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] E 20171231 54868-0617_38d38a30-e45d-428c-b3c9-6c56d71c7628 54868-0617 HUMAN PRESCRIPTION DRUG Diazepam Diazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020213 ANDA ANDA071583 Physicians Total Care, Inc. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-0634_242d8816-a52b-4df5-ac07-f3ebf13004b8 54868-0634 HUMAN PRESCRIPTION DRUG BLEPHAMIDE sulfacetamide sodium and prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19611001 NDA NDA012813 Physicians Total Care, Inc. SULFACETAMIDE SODIUM; PREDNISOLONE ACETATE 100; 2 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0644_158f00a6-9a60-40d6-8a7b-08a021c6201b 54868-0644 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940901 ANDA ANDA062447 Physicians Total Care, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-0649_1a1f53f2-5434-4359-b1ef-f21bed5084a9 54868-0649 HUMAN PRESCRIPTION DRUG Bacitracin Bacitracin OINTMENT OPHTHALMIC 19940429 ANDA ANDA061212 Physicians Total Care, Inc. BACITRACIN 500 [iU]/g Decreased Cell Wall Synthesis & Repair [PE] E 20171231 54868-0654_a0b71c8d-c645-40a9-8e10-ccc5ec17cd4e 54868-0654 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin FOR SUSPENSION ORAL 20080304 ANDA ANDA065283 Physicians Total Care, Inc. CLARITHROMYCIN 250 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-0667_a6d988da-80ed-4d4c-9eec-36aeeb274aa7 54868-0667 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride and Hydrochlorothiazide Amiloride Hydrochloride and Hydrochlorothiazide TABLET ORAL 19960516 ANDA ANDA073209 Physicians Total Care, Inc. AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-0668_79201e83-d9e6-42a7-98b6-bd51edbdc233 54868-0668 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050826 NDA NDA021259 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-0691_68cbc444-1325-4c72-ad66-9f6fef274be0 54868-0691 HUMAN PRESCRIPTION DRUG NITROSTAT Nitroglycerin TABLET ORAL 19950811 NDA NDA021134 Physicians Total Care, Inc. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 54868-0696_94674abb-9b63-4684-8e32-567c07e13cbb 54868-0696 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19950818 ANDA ANDA078955 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-0699_2956359d-bffb-4cd1-850f-9c8d21f975bc 54868-0699 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide TABLET ORAL 19930526 ANDA ANDA086513 Physicians Total Care, Inc. SPIRONOLACTONE; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-0700_91fda3d6-bdfe-4dcd-84ea-32817ce41a78 54868-0700 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 19940325 ANDA ANDA040353 Physicians Total Care, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 54868-0708_0dfdc3c3-894e-46ea-ab95-840798d5a60c 54868-0708 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19941228 ANDA ANDA064053 Physicians Total Care, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0733_e6ce1d8c-e996-4b57-b6b3-3f312b449886 54868-0733 HUMAN PRESCRIPTION DRUG Methylphenidate Methylphenidate hydrochloride TABLET ORAL 20050324 ANDA ANDA040220 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-0735_361fbed9-bece-4912-8935-408bec774c04 54868-0735 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 19950424 ANDA ANDA089859 Physicians Total Care, Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 54868-0736_c9aa61c7-8870-4641-9b68-dc761eb6070b 54868-0736 HUMAN PRESCRIPTION DRUG Antibiotic Ear (Neo/Polym/HC) Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Physicians Total Care, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0762_2dae6094-9c74-4fbc-84da-4ac6f3857a13 54868-0762 HUMAN PRESCRIPTION DRUG Cyanocobalamin cyanocobalamin INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20030918 ANDA ANDA080737 Physicians Total Care, Inc. CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 54868-0765_bff10dca-7798-480b-9e0d-397161cc6756 54868-0765 HUMAN PRESCRIPTION DRUG GLYCOPYRROLATE glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110506 NDA NDA017558 Physicians Total Care, Inc. GLYCOPYRROLATE .2 mg/mL E 20171231 54868-0767_89085b2b-c676-4f2f-9ed4-2e04986fe137 54868-0767 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20070316 ANDA ANDA080205 Physicians Total Care, Inc. POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-0792_80fd7466-afa0-41c5-ab2d-05315b348aa6 54868-0792 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19951004 ANDA ANDA083177 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-0795_723ef500-4b12-4d0d-b926-ae59e21fe0e0 54868-0795 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20070430 ANDA ANDA077270 Physicians Total Care, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-0800_0ae08af3-f42a-4025-b137-f104de54d9ce 54868-0800 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19930106 ANDA ANDA071293 Physicians Total Care, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] E 20171231 54868-0805_11c40932-8c8f-4a48-8b1f-c0fa4c7dbaa7 54868-0805 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20070917 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-0816_e267b61d-1b16-4620-8f66-d62b5e31d19d 54868-0816 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19960404 ANDA ANDA040245 Physicians Total Care, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV E 20171231 54868-0818_1a77dadd-9c05-4f77-9b5e-7771c69be2da 54868-0818 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19950123 ANDA ANDA040161 Physicians Total Care, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 54868-0823_f25888eb-e871-4f73-a93d-cfda73a099c2 54868-0823 HUMAN PRESCRIPTION DRUG Felodipine felodipine TABLET, FILM COATED ORAL 20051108 ANDA ANDA075896 Physicians Total Care, Inc. FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 54868-0826_f25888eb-e871-4f73-a93d-cfda73a099c2 54868-0826 HUMAN PRESCRIPTION DRUG Felodipine felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050121 ANDA ANDA075896 Physicians Total Care, Inc. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 54868-0836_ac265bcb-510d-41b1-bf47-8eeac3bbbd66 54868-0836 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20020415 ANDA ANDA084122 Physicians Total Care, Inc. PREDNISONE 10 mg/1 E 20171231 54868-0840_776a59d7-9876-49e5-96c8-fe45230c6e49 54868-0840 HUMAN PRESCRIPTION DRUG Ery-Tab erythromycin TABLET, DELAYED RELEASE ORAL 19990928 ANDA ANDA062298 Physicians Total Care, Inc. ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-0843_53a3532a-770a-4857-8a2c-661ccb8b84d3 54868-0843 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19950222 ANDA ANDA086414 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0844_634d0e7d-3160-42d7-b2cf-f1ab9ac6ac84 54868-0844 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 19950222 ANDA ANDA085692 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0845_31cc3a65-8c42-4469-9787-7622ae456f84 54868-0845 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20071009 ANDA ANDA077884 Physicians Total Care, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 54868-0846_31cc3a65-8c42-4469-9787-7622ae456f84 54868-0846 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20090701 ANDA ANDA077884 Physicians Total Care, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 54868-0854_8fb54677-a6b7-4c9d-88fb-f7abc1ba13e5 54868-0854 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol CAPSULE, EXTENDED RELEASE ORAL 20070502 ANDA ANDA078065 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-0860_9a8448b0-90a2-4e37-b72c-4a3788b83b73 54868-0860 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20090708 ANDA ANDA040419 Physicians Total Care, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 54868-0875_4ce2b8a7-5adb-4a07-8886-7e8ab0b7125c 54868-0875 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 19990727 ANDA ANDA070624 Physicians Total Care, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-0879_6a31de21-7f3b-428e-9c95-76b8f7271f81 54868-0879 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20070704 ANDA ANDA071891 Physicians Total Care, Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-0890_54642793-18db-4fca-9056-a2ca5a740e59 54868-0890 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 19950807 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-0908_ac265bcb-510d-41b1-bf47-8eeac3bbbd66 54868-0908 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20091210 ANDA ANDA084283 Physicians Total Care, Inc. PREDNISONE 50 mg/1 E 20171231 54868-0916_537cd838-05f2-44f4-aeb2-89c42f153e3c 54868-0916 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19960510 ANDA ANDA084613 Physicians Total Care, Inc DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0922_cfecce09-96dc-4fbe-b045-999f77e91623 54868-0922 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 19950426 ANDA ANDA074464 Physicians Total Care, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-0927_537cd838-05f2-44f4-aeb2-89c42f153e3c 54868-0927 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20090128 ANDA ANDA084611 Physicians Total Care, Inc DEXAMETHASONE .5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0935_11c40932-8c8f-4a48-8b1f-c0fa4c7dbaa7 54868-0935 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20081024 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-0937_b45d4341-5024-48c3-9608-e7c602d84453 54868-0937 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20040817 ANDA ANDA061454 Physicians Total Care, Inc. DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-0946_84620585-df4d-483b-bab8-d904ffb0220c 54868-0946 HUMAN PRESCRIPTION DRUG Erythromycin erythromycin SOLUTION TOPICAL 19960329 ANDA ANDA064187 Physicians Total Care, Inc. ERYTHROMYCIN 20 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-0971_da5a96d1-9f4b-439b-890e-a39bc29bdf5e 54868-0971 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL GRANULE, FOR SUSPENSION ORAL 20001011 ANDA ANDA062759 Physicians Total Care, Inc. ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL 200; 600 mg/5mL; mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 54868-0973_66df8564-8239-4078-ba9a-35a11cfb36e7 54868-0973 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 19941215 ANDA ANDA019137 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-0984_13daa2c3-6403-4379-9be0-5646677fa9a2 54868-0984 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20071016 ANDA ANDA075661 Physicians Total Care, Inc. IBUPROFEN 200 mg/1 E 20171231 54868-0988_0fea6c8b-9c2a-4ade-8b07-bc88e081a2fd 54868-0988 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20040603 ANDA ANDA071322 Physicians Total Care, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-1029_30004e84-7a7b-46ac-b6fe-bd1835dd9fcf 54868-1029 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20010213 ANDA ANDA040650 Physicians Total Care, Inc. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10; 6.25 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] CV E 20171231 54868-1036_24450668-ed5c-4651-9365-6f3d3bc102e4 54868-1036 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 20040621 ANDA ANDA089718 Physicians Total Care, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 54868-1037_cb730544-1622-46e5-b5ae-9586dbcec689 54868-1037 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, Caffeine and Codeine Phosphate Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE ORAL 19980602 ANDA ANDA074359 Physicians Total Care, Inc. BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII E 20171231 54868-1040_536a3711-8e82-4393-82f2-910dcbde9468 54868-1040 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate gentamicin sulfate OINTMENT OPHTHALMIC 19940921 ANDA ANDA065024 Physicians Total Care, Inc. GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 54868-1050_3144133b-0993-4e96-b5c1-78a79dbad72b 54868-1050 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20000501 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 E 20171231 54868-1060_53a3532a-770a-4857-8a2c-661ccb8b84d3 54868-1060 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19941122 ANDA ANDA086415 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-1070_a805e81e-de84-422d-bb26-22aae20a3412 54868-1070 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone neomycin sulfate, polymyxin b sulfate and dexamethasone SUSPENSION OPHTHALMIC 20071204 ANDA ANDA062721 Physicians Total Care, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-1073_0319ae11-7457-4e15-98f5-a0a6bcaff666 54868-1073 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate TABLET ORAL 19930813 ANDA ANDA072637 Physicians Total Care, Inc. ALBUTEROL SULFATE 2.4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-1078_3330f4f5-55fd-4d62-b80d-fbea0340399e 54868-1078 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130627 ANDA ANDA078494 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-1082_a5ed6899-9939-456c-9735-a418b7ce6357 54868-1082 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20000107 ANDA ANDA040101 Physicians Total Care, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-1093_54642793-18db-4fca-9056-a2ca5a740e59 54868-1093 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 19960924 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-1103_086dda45-8f22-478c-8724-4c97b87499fe 54868-1103 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20030714 ANDA ANDA085159 Physicians Total Care, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 54868-1110_b34b187e-d110-48df-9687-c255eec7910f 54868-1110 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 19970317 ANDA ANDA071611 Physicians Total Care, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 54868-1118_6a31de21-7f3b-428e-9c95-76b8f7271f81 54868-1118 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20070705 ANDA ANDA071795 Physicians Total Care, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-1119_ac265bcb-510d-41b1-bf47-8eeac3bbbd66 54868-1119 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20041005 ANDA ANDA087800 Physicians Total Care, Inc. PREDNISONE 1 mg/1 E 20171231 54868-1129_01172abb-07b0-4cc9-ab0c-8922c8993c44 54868-1129 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20070719 ANDA ANDA077122 Physicians Total Care, Inc. DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] E 20171231 54868-1157_4f8bce58-fbdc-44ce-b809-4da45d92ff7b 54868-1157 HUMAN PRESCRIPTION DRUG BLEPHAMIDE sulfacetamide sodium and prednisolone acetate OINTMENT OPHTHALMIC 20120304 ANDA ANDA087748 Physicians Total Care, Inc. SULFACETAMIDE SODIUM; PREDNISOLONE ACETATE 100; 2 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-1171_c3a479d1-7c29-46cf-aa03-080c5b64f28c 54868-1171 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 20030930 ANDA ANDA064071 Physicians Total Care, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-1173_c3a479d1-7c29-46cf-aa03-080c5b64f28c 54868-1173 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 19950222 ANDA ANDA064071 Physicians Total Care, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-1183_ac265bcb-510d-41b1-bf47-8eeac3bbbd66 54868-1183 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030819 ANDA ANDA087342 Physicians Total Care, Inc. PREDNISONE 20 mg/1 E 20171231 54868-1192_3fa75a0d-6a68-4ba5-87c9-69520fa4dad4 54868-1192 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin and Polymyxin B Sulfates and Dexamethasone OINTMENT OPHTHALMIC 20021111 ANDA ANDA064063 Physicians Total Care, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-1195_bdc25457-b62a-4b2f-8304-440fad1a06bc 54868-1195 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 20100209 ANDA ANDA084840 Physicians Total Care, Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] E 20171231 54868-1198_95947bb4-46bb-435d-bb1c-d646aa556fdb 54868-1198 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19950227 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ASPIRIN 325 mg/1 E 20171231 54868-1199_e17cb260-9274-43d0-9d9a-fa590b82d681 54868-1199 HUMAN PRESCRIPTION DRUG Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate OINTMENT OPHTHALMIC 20041112 ANDA ANDA064028 Physicians Total Care, Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 54868-1207_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-1207 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20050112 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-1223_a03d104e-6b42-4cfc-9e80-ec379c40057b 54868-1223 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19970508 ANDA ANDA071524 Physicians Total Care, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 54868-1227_4a3ced1f-cd7a-4b39-b0cf-63f4c7bbe4dc 54868-1227 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride LIQUID ORAL 20021022 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 54868-1233_a8fc7135-51ab-4d13-b743-333823956941 54868-1233 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 20090914 ANDA ANDA040191 Physicians Total Care, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-1234_3a76a4d0-bd0f-409e-adf0-0cbaae53243c 54868-1234 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20120817 ANDA ANDA079234 Physicians Total Care, Inc. TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 54868-1239_dadf8ed3-b155-4449-a74e-1ebdf9b10a06 54868-1239 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20070122 ANDA ANDA077031 Physicians Total Care, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-1259_d975e88b-476c-463b-9600-3fbcdb0e86f2 54868-1259 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20041115 NDA NDA009218 Physicians Total Care, Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-1317_ee02d645-3e12-4f1e-97cb-167be847aa76 54868-1317 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 19960411 ANDA ANDA070980 Physicians Total Care, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-1323_b0edb786-44c1-43ea-afc0-78df4970ce86 54868-1323 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19950814 ANDA ANDA040863 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-1326_9ecceec7-df5f-4210-a52f-086f1859e8fb 54868-1326 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 20090129 ANDA ANDA072579 Physicians Total Care, Inc. NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 54868-1328_8d8a30ce-654a-47f5-be45-263d691c8e22 54868-1328 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 19960726 ANDA ANDA070343 Physicians Total Care, Inc. METHYLDOPA 500 mg/1 E 20171231 54868-1332_5b7afa4a-3bbd-4a32-a465-ca745471e174 54868-1332 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20030521 ANDA ANDA040537 Physicians Total Care, Inc. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 E 20171231 54868-1334_55592f54-580b-4049-bbab-d82e7c3255a4 54868-1334 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19941209 ANDA ANDA073589 Physicians Total Care, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 54868-1335_bd26a0a2-2f4c-47ae-948f-e6868ac91132 54868-1335 HUMAN PRESCRIPTION DRUG LITHIUM CARBONATE Lithium Carbonate CAPSULE ORAL 19950116 ANDA ANDA090702 Physicians Total Care, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 54868-1338_7c5b3625-4922-4296-b34b-5336b0ca2099 54868-1338 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19930723 ANDA ANDA072927 Physicians Total Care, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-1344_5fecfa8f-183c-42f2-af2f-397b66a891d5 54868-1344 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19930202 ANDA ANDA090442 Physicians Total Care, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-1362_a7a881da-c9ca-4b26-b58c-20f8552a360d 54868-1362 HUMAN PRESCRIPTION DRUG SELENIUM SULFIDE SELENIUM SULFIDE LOTION TOPICAL 20060925 ANDA ANDA089996 Physicians Total Care, Inc. SELENIUM SULFIDE 2.5 g/100mL E 20171231 54868-1380_b45d4341-5024-48c3-9608-e7c602d84453 54868-1380 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19921021 ANDA ANDA061454 Physicians Total Care, Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-1385_e5925c6f-04bc-4d69-9fd4-7a122bdd6edd 54868-1385 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin SUSPENSION ORAL 19930622 ANDA ANDA065081 Physicians Total Care, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-1386_08ea9c20-4cfb-4297-8819-0d1ccfa22394 54868-1386 HUMAN PRESCRIPTION DRUG Erythromycin Base Filmtab Erythromycin TABLET, FILM COATED ORAL 19950721 ANDA ANDA061621 Physicians Total Care, Inc. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-1387_08ea9c20-4cfb-4297-8819-0d1ccfa22394 54868-1387 HUMAN PRESCRIPTION DRUG Erythromycin Base Filmtab Erythromycin TABLET, FILM COATED ORAL 19961209 ANDA ANDA061621 Physicians Total Care, Inc. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-1425_30d87f61-2606-4509-bf4c-6cfb97b4ea68 54868-1425 HUMAN PRESCRIPTION DRUG Nystatin nystatin OINTMENT TOPICAL 20070411 ANDA ANDA062124 Physicians Total Care, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 54868-1429_2232ce07-e218-4907-8f20-1e8fe3277dde 54868-1429 HUMAN OTC DRUG Humulin N Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 19941024 NDA NDA018781 Physicians Total Care, Inc. INSULIN HUMAN 100 [iU]/mL E 20171231 54868-1432_f0646bea-d356-441c-8b53-a89245a3762c 54868-1432 HUMAN PRESCRIPTION DRUG Cenestin synthetic conjugated estrogens, A TABLET, FILM COATED ORAL 20080317 NDA NDA020992 Physicians Total Care, Inc. ESTROGENS, CONJUGATED SYNTHETIC A 1.25 mg/1 E 20171231 54868-1461_274059ad-0c68-4ec2-ab55-5f5f48a1c380 54868-1461 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20070704 ANDA ANDA089807 Physicians Total Care, Inc. THEOPHYLLINE ANHYDROUS 100 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 54868-1462_e13f3086-bfe3-45b6-9842-efad504a4d95 54868-1462 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 20040614 NDA NDA011722 Physicians Total Care, Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 54868-1463_e13f3086-bfe3-45b6-9842-efad504a4d95 54868-1463 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 20051003 NDA NDA012546 Physicians Total Care, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 54868-1486_c239fe20-4f79-4610-8e05-e6e0f52c509d 54868-1486 HUMAN PRESCRIPTION DRUG Dilantin phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20030819 ANDA ANDA084349 Physicians Total Care, Inc. PHENYTOIN SODIUM 30 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 54868-1517_8fb54677-a6b7-4c9d-88fb-f7abc1ba13e5 54868-1517 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol CAPSULE, EXTENDED RELEASE ORAL 20070330 ANDA ANDA078065 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-1518_8fb54677-a6b7-4c9d-88fb-f7abc1ba13e5 54868-1518 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol CAPSULE, EXTENDED RELEASE ORAL 19940314 ANDA ANDA078065 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-1523_0825579e-56f9-4c3a-8c17-3a60abdc225d 54868-1523 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20050714 ANDA ANDA076258 Physicians Total Care, Inc. FENTANYL 10.2 mg/[USP'U] Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-1531_68c1b49b-a16c-40a9-9b5e-76df9e8d19e2 54868-1531 HUMAN PRESCRIPTION DRUG Cortisporin neomycin sulfate, polymyxin B sulfate and hydrocortisone acetate CREAM TOPICAL 19940719 NDA NDA050218 Physicians Total Care, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE ACETATE 3.5; 10000; 5 mg/g; U/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-1538_68cbc444-1325-4c72-ad66-9f6fef274be0 54868-1538 HUMAN PRESCRIPTION DRUG NITROSTAT Nitroglycerin TABLET ORAL 19940922 NDA NDA021134 Physicians Total Care, Inc. NITROGLYCERIN .3 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 54868-1547_a6a3998d-d6aa-40c3-8959-955670b5c0db 54868-1547 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071995 Physicians Total Care, Inc. PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-1587_9db4dca1-1472-4246-8366-219c621f9e5f 54868-1587 HUMAN OTC DRUG Sarna pramoxine hydrochloride LOTION TOPICAL 20080328 OTC MONOGRAPH NOT FINAL part348 Physicians Total Care, Inc. PRAMOXINE HYDROCHLORIDE 1 mg/mL E 20171231 54868-1590_ba942508-13d1-4523-a66a-c8534c3285c3 54868-1590 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 19941122 ANDA ANDA087356 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-1591_ba942508-13d1-4523-a66a-c8534c3285c3 54868-1591 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20060918 ANDA ANDA087357 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-1613_8763e5a9-9b87-493d-83d2-78042b0feed7 54868-1613 HUMAN PRESCRIPTION DRUG PROMETHEGAN Promethazine Hydrochloride SUPPOSITORY RECTAL 19960617 ANDA ANDA087165 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-1616_86e46afc-1269-4276-9985-2bb93fabd31e 54868-1616 HUMAN PRESCRIPTION DRUG Trimethoprim Trimethoprim TABLET ORAL 20120502 ANDA ANDA070049 Physicians Total Care, Inc. TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 54868-1625_c040076a-7a92-4b40-9513-6c15d9cda22f 54868-1625 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 19950814 ANDA ANDA040855 Physicians Total Care, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] E 20171231 54868-1629_48577869-8c72-416e-b7fc-ee1de333a6d4 54868-1629 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20070705 ANDA ANDA072423 Physicians Total Care, Inc. MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-1689_e91e3031-9e0d-41f2-a6da-b04390daaab3 54868-1689 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 19940419 ANDA ANDA073229 Physicians Total Care, Inc. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 54868-1691_fed8d510-c787-407c-8748-a41c6e8cc4a0 54868-1691 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20090727 ANDA ANDA084903 Physicians Total Care, Inc. PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-1700_a1a2b20f-2261-4d4f-8bd8-bac39ed027bf 54868-1700 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20091103 ANDA ANDA087463 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-1704_e6ce1d8c-e996-4b57-b6b3-3f312b449886 54868-1704 HUMAN PRESCRIPTION DRUG Methylphenidate methylphenidate hydrochloride TABLET ORAL 20090514 ANDA ANDA040220 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-1729_84cf82fa-837a-4b2c-a280-6751f38b0c26 54868-1729 HUMAN PRESCRIPTION DRUG Depo-Estradiol estradiol cypionate INJECTION INTRAMUSCULAR 19981016 ANDA ANDA085470 Physicians Total Care, Inc. ESTRADIOL CYPIONATE 5 mg/mL E 20171231 54868-1743_4df671d1-d0ea-4ae0-8385-bb9630ada6b8 54868-1743 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 20070705 ANDA ANDA083365 Physicians Total Care, Inc. HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-1744_537cd838-05f2-44f4-aeb2-89c42f153e3c 54868-1744 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19960621 ANDA ANDA084610 Physicians Total Care, Inc DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-1750_b8427898-2a74-41d0-aed2-4839df76e139 54868-1750 HUMAN PRESCRIPTION DRUG Cytomel liothyronine sodium TABLET ORAL 20021230 NDA NDA010379 Physicians Total Care, Inc. LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] E 20171231 54868-1760_ed20f459-3294-4acc-b50f-9928ff55e743 54868-1760 HUMAN PRESCRIPTION DRUG Retin-A tretinoin CREAM TOPICAL 19930528 NDA NDA019049 Physicians Total Care, Inc. TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-1780_9185f276-5046-4707-9287-6c4662b1c18f 54868-1780 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 20031110 ANDA ANDA060456 Physicians Total Care, Inc. PENICILLIN V POTASSIUM 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-1791_931dba86-5a94-4921-953b-68774aedd1f4 54868-1791 HUMAN OTC DRUG Acetaminophen Acetaminophen LIQUID ORAL 20040707 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 54868-1795_e4958f97-9164-4b61-8d8c-33f634a9952c 54868-1795 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 19950515 NDA NDA006488 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 54868-1796_e4958f97-9164-4b61-8d8c-33f634a9952c 54868-1796 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 19950515 NDA NDA006488 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 10; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 54868-1798_e4958f97-9164-4b61-8d8c-33f634a9952c 54868-1798 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 19931109 NDA NDA006488 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 54868-1802_8e359d73-d777-49d9-af50-724344f1a879 54868-1802 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20070214 ANDA ANDA078211 Physicians Total Care, Inc. QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-1804_2c1543b0-c533-48b8-8620-0bebe302bf55 54868-1804 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 19930921 ANDA ANDA040804 Physicians Total Care, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 54868-1819_a097b2cb-9177-4e62-a4b6-cd40fefe6c83 54868-1819 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080523 ANDA ANDA077873 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-1827_859c27a4-912c-4623-b6af-e819aad79ad0 54868-1827 HUMAN PRESCRIPTION DRUG LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 20030508 ANDA ANDA040014 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 54868-1852_4ed8e07c-0fb2-4bfe-86c3-8e4196d98ecb 54868-1852 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050120 ANDA ANDA075665 Physicians Total Care, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-1857_d1a436e2-b35a-4bf2-9386-da4190a4c03e 54868-1857 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 19980929 ANDA ANDA065061 Physicians Total Care, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 54868-1866_abda8405-5e00-46b9-aa1e-742743e5a3e0 54868-1866 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19950424 ANDA ANDA072011 Physicians Total Care, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-1867_97fa8e59-d2cc-4f67-9fb8-0e1b3ce6885a 54868-1867 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 19941219 ANDA ANDA087953 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-1871_c0f9e181-57bf-4442-bfc0-b6711f0e3a41 54868-1871 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950424 ANDA ANDA077877 Physicians Total Care, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-1873_6e41e4ed-c643-4924-bf9b-53ebd931b2a0 54868-1873 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20030327 ANDA ANDA078807 Physicians Total Care, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 54868-1890_ec82c251-eebc-4210-9920-6cd5a827a177 54868-1890 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20041101 NDA NDA021366 Physicians Total Care, Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-1934_9c4972f6-6db3-468b-be1a-1af272dd1ed3 54868-1934 HUMAN OTC DRUG Tussin DM Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 20090203 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL E 20171231 54868-1947_9ae532e0-67f1-40bb-8bb5-a8fdf168b679 54868-1947 HUMAN OTC DRUG Saline Nasal Saline Nasal SPRAY NASAL 20021227 OTC MONOGRAPH FINAL part349 Physicians Total Care, Inc. SODIUM CHLORIDE 6.5 mg/mL E 20171231 54868-1949_b5f46d0d-6971-4954-96ca-01bd0faa52eb 54868-1949 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070917 ANDA ANDA086242 Physicians Total Care, Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 54868-1959_a03d104e-6b42-4cfc-9e80-ec379c40057b 54868-1959 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19920220 ANDA ANDA071525 Physicians Total Care, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 54868-1964_21a83a08-cb04-448b-9897-83ec9538c9c2 54868-1964 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19990928 ANDA ANDA071595 Physicians Total Care, Inc. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-1967_ab1f78ab-63fe-4995-b0a9-77e0e9987fc3 54868-1967 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20041130 ANDA ANDA070923 Physicians Total Care, Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54868-1971_c0f9e181-57bf-4442-bfc0-b6711f0e3a41 54868-1971 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19990304 ANDA ANDA077877 Physicians Total Care, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-1973_08081de2-2096-499e-b5b3-067fbbbef571 54868-1973 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 20021125 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 E 20171231 54868-1978_4ed8e07c-0fb2-4bfe-86c3-8e4196d98ecb 54868-1978 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050120 ANDA ANDA075665 Physicians Total Care, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-1980_59a95728-34a6-4741-8807-cba7da17e1ab 54868-1980 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20071109 ANDA ANDA078332 Physicians Total Care, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 54868-1986_7704aea8-fedc-40b6-bd09-b0cb2c40b00f 54868-1986 HUMAN OTC DRUG Guaifenesin DM Guaifenesin and Dextromethorphan Hydrobromide SYRUP ORAL 19991116 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 54868-1990_9f2ecbab-8244-47c9-bcef-d8d0a4420af5 54868-1990 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 20071004 ANDA ANDA040649 Physicians Total Care, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-1992_5192b19b-5bd1-4f62-9cad-b120de7dbb74 54868-1992 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20041027 ANDA ANDA089773 Physicians Total Care, Inc. NITROGLYCERIN 10 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 54868-2007_d7351407-024c-4944-83f1-3edca2aaf298 54868-2007 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 20030609 ANDA ANDA086831 Physicians Total Care, Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 54868-2032_7fbb6c19-6d9f-48f0-85f7-9583248d654b 54868-2032 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride SOLUTION ORAL 19940801 ANDA ANDA040010 Physicians Total Care, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 54868-2038_27378bdf-dca8-42b0-8727-fb22c43d9f10 54868-2038 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20061219 ANDA ANDA040420 Physicians Total Care, Inc. PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 54868-2062_6c02417b-bbde-4946-a69e-38f01c258ce2 54868-2062 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000615 ANDA ANDA070254 Physicians Total Care, Inc. NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] E 20171231 54868-2064_810f5846-8f33-4039-91de-88d2ffd5d822 54868-2064 HUMAN PRESCRIPTION DRUG LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 19940823 ANDA ANDA088327 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 54868-2077_dd6128c5-b642-470c-beb2-352c1ff5df0f 54868-2077 HUMAN PRESCRIPTION DRUG Levocetirizine dihydrochloride Levocetirizine dihydrochloride TABLET ORAL 20101230 ANDA ANDA090229 Physicians Total Care, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 54868-2088_230ef06f-75a4-4bc7-942c-63ab2c7cbec8 54868-2088 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20050929 ANDA ANDA040737 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-2093_d4312878-bdb9-4241-98e0-c77553ca4286 54868-2093 HUMAN OTC DRUG Maalox Antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20061212 OTC MONOGRAPH FINAL part332 Physicians Total Care, Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL E 20171231 54868-2094_7c144dee-76e9-4ec7-be01-0219ceb29ad2 54868-2094 HUMAN PRESCRIPTION DRUG Oxycodone and Aspirin oxycodone and aspirin TABLET ORAL 19980227 ANDA ANDA040255 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; ASPIRIN 4.5; .38; 325 mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE] CII E 20171231 54868-2118_19b1a56b-4e29-4973-9ca0-b3902db4f69d 54868-2118 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 19960620 ANDA ANDA072741 Physicians Total Care, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] E 20171231 54868-2126_0fea6c8b-9c2a-4ade-8b07-bc88e081a2fd 54868-2126 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20080723 ANDA ANDA071307 Physicians Total Care, Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-2128_d975e88b-476c-463b-9600-3fbcdb0e86f2 54868-2128 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20040927 NDA NDA009218 Physicians Total Care, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-2131_11c40932-8c8f-4a48-8b1f-c0fa4c7dbaa7 54868-2131 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20050309 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-2134_da88fa99-63c7-4348-b893-00302c93e12b 54868-2134 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 19920922 ANDA ANDA077002 Physicians Total Care, Inc. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 54868-2143_c5bb6eaa-189b-4632-bd2f-ea0183c680b3 54868-2143 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 19950804 ANDA ANDA089682 Physicians Total Care, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-2145_7c5b3625-4922-4296-b34b-5336b0ca2099 54868-2145 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19930629 ANDA ANDA072926 Physicians Total Care, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-2149_9aab3cb6-b28f-46e0-bcab-227f8d47cae7 54868-2149 HUMAN PRESCRIPTION DRUG Cardizem CD Diltiazem Hydrochloride CAPSULE ORAL 19930616 NDA NDA020062 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-2157_b4a37481-c0d3-43dc-85f1-8cca6c6d8ba8 54868-2157 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20061211 ANDA ANDA071655 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-2176_4a4d57fc-38b3-48a9-af44-abacdb20edbf 54868-2176 HUMAN PRESCRIPTION DRUG Cytotec misoprostol TABLET ORAL 19960702 NDA NDA019268 Physicians Total Care, Inc. MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 54868-2180_d6595eb0-875e-4ae3-baa4-e4b955eb272c 54868-2180 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19970303 ANDA ANDA078010 Physicians Total Care, Inc. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 54868-2183_5192b19b-5bd1-4f62-9cad-b120de7dbb74 54868-2183 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20041012 ANDA ANDA089772 Physicians Total Care, Inc. NITROGLYCERIN 5 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 54868-2185_f96d2943-9a0e-47b5-8c05-3d61ded6b051 54868-2185 HUMAN PRESCRIPTION DRUG Naftin naftifine hydrochloride GEL TOPICAL 20051229 NDA NDA019356 Physicians Total Care, Inc. NAFTIFINE HYDROCHLORIDE 10 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] E 20171231 54868-2198_311a004f-9402-46ba-85bd-a211aadaed57 54868-2198 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20050121 ANDA ANDA074131 Physicians Total Care, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-2199_311a004f-9402-46ba-85bd-a211aadaed57 54868-2199 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19941006 ANDA ANDA074131 Physicians Total Care, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-2200_5c7fe409-289d-43d1-a9d4-1ee8eda9b07c 54868-2200 HUMAN PRESCRIPTION DRUG Verelan verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 20040812 NDA NDA019614 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-2207_5651bc48-1227-4ca9-aaf9-805771c27090 54868-2207 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000509 ANDA ANDA074587 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-2211_cf206f2d-793d-4301-a75a-ed2b1d90ba4c 54868-2211 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20080807 ANDA ANDA078306 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 100 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-2221_5fecfa8f-183c-42f2-af2f-397b66a891d5 54868-2221 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19921112 ANDA ANDA090441 Physicians Total Care, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-2223_e3320c0b-0507-4e09-a5c5-631a64e4b90a 54868-2223 HUMAN PRESCRIPTION DRUG Elocon mometasone furoate CREAM TOPICAL 19940531 NDA NDA019625 Physicians Total Care, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-2240_f8b3199b-55fe-4ecb-a66c-08840d44f177 54868-2240 HUMAN PRESCRIPTION DRUG Naftin naftifine hydrochloride CREAM TOPICAL 20100617 NDA NDA019599 Physicians Total Care, Inc. NAFTIFINE HYDROCHLORIDE 10 mg/g Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] E 20171231 54868-2252_d975e88b-476c-463b-9600-3fbcdb0e86f2 54868-2252 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 19950731 NDA NDA009218 Physicians Total Care, Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-2264_3fa6b141-44f0-4e51-bd46-1127d540dd9b 54868-2264 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide fluocinolone acetonide SOLUTION TOPICAL 19960403 ANDA ANDA088167 Physicians Total Care, Inc. FLUOCINOLONE ACETONIDE .1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-2271_54642793-18db-4fca-9056-a2ca5a740e59 54868-2271 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20001205 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM .3 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-2276_4c3e2bbe-6a22-45ad-be50-3ba6281a6d07 54868-2276 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20050301 ANDA ANDA072838 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-2277_4c3e2bbe-6a22-45ad-be50-3ba6281a6d07 54868-2277 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19960516 ANDA ANDA072838 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-2284_21a83a08-cb04-448b-9897-83ec9538c9c2 54868-2284 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19961003 ANDA ANDA071422 Physicians Total Care, Inc. DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-2290_4c3e2bbe-6a22-45ad-be50-3ba6281a6d07 54868-2290 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19950424 ANDA ANDA072838 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-2296_b525c891-0d0c-4063-b4a4-542b92d12bd8 54868-2296 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19961024 ANDA ANDA070278 Physicians Total Care, Inc. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] E 20171231 54868-2298_e23185a6-9adb-4fbf-93a6-946cfc655419 54868-2298 HUMAN OTC DRUG Kaopectate Regular Strength Vanilla Flavor Anti Diarrheal bismuth subsalicylate LIQUID ORAL 20080512 OTC MONOGRAPH FINAL part335 Physicians Total Care, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL E 20171231 54868-2299_b2442be8-4bea-4091-8ef2-28b2a8b2fb93 54868-2299 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAVENOUS 20050929 ANDA ANDA018579 Physicians Total Care, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 54868-2314_9a6689c1-b181-4395-a2d7-772bafb3aa7b 54868-2314 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 19950927 ANDA ANDA040765 Physicians Total Care, Inc. FOLIC ACID 1 mg/1 E 20171231 54868-2317_21a83a08-cb04-448b-9897-83ec9538c9c2 54868-2317 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 19950103 ANDA ANDA071697 Physicians Total Care, Inc. DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-2319_fad3dfbe-5257-4305-ac6e-d7a6a4befae8 54868-2319 HUMAN PRESCRIPTION DRUG Leflunomide leflunomide TABLET, FILM COATED ORAL 20060710 ANDA ANDA077087 Physicians Total Care, Inc. LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] E 20171231 54868-2323_4c3e2bbe-6a22-45ad-be50-3ba6281a6d07 54868-2323 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20110930 ANDA ANDA072838 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-2331_810f5846-8f33-4039-91de-88d2ffd5d822 54868-2331 HUMAN PRESCRIPTION DRUG LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 19940628 ANDA ANDA088299 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 54868-2335_60b11c09-e7ec-4f59-97b9-8a4237840578 54868-2335 HUMAN PRESCRIPTION DRUG Cozaar losartan potassium TABLET, FILM COATED ORAL 20030806 NDA NDA020386 Physicians Total Care, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-2337_a407b7b0-d214-4f75-9c48-669e3421d5c9 54868-2337 HUMAN OTC DRUG Colace docusate sodium CAPSULE ORAL 20111108 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. DOCUSATE SODIUM 100 mg/1 E 20171231 54868-2345_23fcc757-df53-458a-8ee1-20d1c78ee432 54868-2345 HUMAN OTC DRUG Milk of Magnesia MAGNESIUM HYDROXIDE SUSPENSION ORAL 19970619 OTC MONOGRAPH FINAL part334 Physicians Total Care, Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL E 20171231 54868-2349_c0f9e181-57bf-4442-bfc0-b6711f0e3a41 54868-2349 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950719 ANDA ANDA077877 Physicians Total Care, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-2350_55fc05f3-675b-4ab1-97f1-e6a3c1482245 54868-2350 HUMAN PRESCRIPTION DRUG Lotensin Benazepril Hydrochloride TABLET ORAL 20031104 NDA NDA019851 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-2351_55fc05f3-675b-4ab1-97f1-e6a3c1482245 54868-2351 HUMAN PRESCRIPTION DRUG Lotensin Benazepril Hydrochloride TABLET ORAL 19940323 NDA NDA019851 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-2352_55fc05f3-675b-4ab1-97f1-e6a3c1482245 54868-2352 HUMAN PRESCRIPTION DRUG Lotensin Benazepril Hydrochloride TABLET ORAL 19990224 NDA NDA019851 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-2353_853a8ce2-f42f-48bb-a39f-6562ef8ff151 54868-2353 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20040810 ANDA ANDA074256 Physicians Total Care, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 54868-2357_8426db88-8646-4230-9026-5a04c939621c 54868-2357 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20030204 ANDA ANDA085971 Physicians Total Care, Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-2361_8cae852f-c80a-4a53-b263-537fb9e59f59 54868-2361 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19930324 ANDA ANDA084769 Physicians Total Care, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-2390_3a5158e5-a9df-4826-83bd-1b4e0922b133 54868-2390 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Physicians Total Care, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 54868-2391_3a5158e5-a9df-4826-83bd-1b4e0922b133 54868-2391 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Physicians Total Care, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 54868-2399_587ea494-b2d2-40d6-8c4f-a74e435d23ae 54868-2399 HUMAN OTC DRUG Calcium Carbonate calcium carbon TABLET, CHEWABLE ORAL 19960423 OTC MONOGRAPH FINAL part331 Physicians Total Care, Inc. CALCIUM CARBONATE 500 mg/1 E 20171231 54868-2405_2400c707-fa24-452b-9002-333ae5901675 54868-2405 HUMAN OTC DRUG Aspirin EC aspirin TABLET, COATED ORAL 19930910 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ASPIRIN 325 mg/1 E 20171231 54868-2414_b77c9d7d-6c4c-4716-b724-72e15b3ea4d2 54868-2414 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE ORAL 19970214 ANDA ANDA074035 Physicians Total Care, Inc. KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-2415_b77c9d7d-6c4c-4716-b724-72e15b3ea4d2 54868-2415 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE ORAL 20050815 ANDA ANDA074035 Physicians Total Care, Inc. KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-2416_a516e403-1227-40ba-a414-7be1e2542242 54868-2416 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 Physicians Total Care, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] E 20171231 54868-2433_8426db88-8646-4230-9026-5a04c939621c 54868-2433 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19990913 ANDA ANDA085967 Physicians Total Care, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-2434_8426db88-8646-4230-9026-5a04c939621c 54868-2434 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19950725 ANDA ANDA085970 Physicians Total Care, Inc. AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-2438_bac8c65a-3126-4b90-ab5b-44e663ba4aad 54868-2438 HUMAN PRESCRIPTION DRUG AMOXAPINE amoxapine TABLET ORAL 20110512 ANDA ANDA072689 Physicians Total Care, Inc. AMOXAPINE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-2440_2400c707-fa24-452b-9002-333ae5901675 54868-2440 HUMAN OTC DRUG Aspirin EC aspirin TABLET, COATED ORAL 20001130 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ASPIRIN 81 mg/1 E 20171231 54868-2451_b4447c1c-7a05-481c-aa6f-dec644f294df 54868-2451 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide SOLUTION TOPICAL 19930528 ANDA ANDA074799 Physicians Total Care, Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-2457_902526fc-a17b-481a-98bd-fe9f63a7742d 54868-2457 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20020822 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ACETAMINOPHEN 500 mg/1 E 20171231 54868-2462_b0faccb6-dd69-4b6d-9b67-5bc4865ee711 54868-2462 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 19950727 ANDA ANDA073524 Physicians Total Care, Inc. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 54868-2463_8cae852f-c80a-4a53-b263-537fb9e59f59 54868-2463 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19930101 ANDA ANDA084768 Physicians Total Care, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-2464_ead4d3e2-ae16-4381-a78c-0c4bbd225b3c 54868-2464 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, FILM COATED ORAL 19730103 ANDA ANDA080439 Physicians Total Care, Inc. CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-2470_a0b3b753-bf21-4dfd-8973-6a41ae5e3ec2 54868-2470 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Nystatin and Triamcinolone OINTMENT TOPICAL 20050303 ANDA ANDA063305 Physicians Total Care, Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-2471_52c919c0-4f65-4ed0-9a6d-5fb44d32b39e 54868-2471 HUMAN OTC DRUG Miconazole Nitrate miconazole nitrate CREAM TOPICAL 20120320 OTC MONOGRAPH FINAL part333C Physicians Total Care, Inc. MICONAZOLE NITRATE 20 mg/g E 20171231 54868-2472_e79e2829-414b-424d-b00b-9e61fe07eb84 54868-2472 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20031021 ANDA ANDA074880 Physicians Total Care, Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-2480_34af46e3-e2c0-4360-ae01-f3d30d388a99 54868-2480 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19930910 ANDA ANDA073556 Physicians Total Care, inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-2481_34af46e3-e2c0-4360-ae01-f3d30d388a99 54868-2481 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20040225 ANDA ANDA073556 Physicians Total Care, inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-2482_34af46e3-e2c0-4360-ae01-f3d30d388a99 54868-2482 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20081111 ANDA ANDA073554 Physicians Total Care, inc. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-2489_afff3544-c2ec-4412-96f7-01dad42e094b 54868-2489 HUMAN PRESCRIPTION DRUG Thiamine Hydrochloride Thiamine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010418 ANDA ANDA080556 Physicians Total Care, Inc. THIAMINE HYDROCHLORIDE 100 mg/mL E 20171231 54868-2497_cc8e31d5-d163-400a-9ffe-7beeae5186fa 54868-2497 HUMAN OTC DRUG Bisacodyl Stimulant Laxative Bisacodyl TABLET, DELAYED RELEASE ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. BISACODYL 5 mg/1 E 20171231 54868-2522_9166ec18-da24-4f12-b446-dcf2dcc9d3ca 54868-2522 HUMAN PRESCRIPTION DRUG Neupogen filgrastim INJECTION, SOLUTION INTRAVENOUS 19940608 BLA BLA103353 Physicians Total Care, Inc. FILGRASTIM 300 ug/mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] E 20171231 54868-2523_8bda2b6b-e72d-4955-9fa2-27af10454d34 54868-2523 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19940811 BLA BLA103234 Physicians Total Care, Inc. ERYTHROPOIETIN 10000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] E 20171231 54868-2539_11c40932-8c8f-4a48-8b1f-c0fa4c7dbaa7 54868-2539 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 19950810 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-2541_c9609f8f-7560-4da0-9519-4fabc761261c 54868-2541 HUMAN PRESCRIPTION DRUG Codeine Sulfate codeine sulfate TABLET ORAL 20090715 NDA NDA022402 Physicians Total Care, Inc. CODEINE SULFATE 60 mg/1 CII E 20171231 54868-2552_21a83a08-cb04-448b-9897-83ec9538c9c2 54868-2552 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20030610 ANDA ANDA071608 Physicians Total Care, Inc. DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-2570_b525c891-0d0c-4063-b4a4-542b92d12bd8 54868-2570 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19990429 ANDA ANDA070278 Physicians Total Care, Inc. HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] E 20171231 54868-2638_68dbd082-1862-4fc8-9b90-be362df5fc68 54868-2638 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20040603 NDA NDA021402 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-2655_d0858161-2ad5-447c-8e65-b63cec7e918f 54868-2655 HUMAN OTC DRUG PanOxyl benzoyl peroxide SOAP TOPICAL 20080331 OTC MONOGRAPH NOT FINAL part333D Physicians Total Care, Inc. BENZOYL PEROXIDE 5.65 g/1 E 20171231 54868-2656_d0858161-2ad5-447c-8e65-b63cec7e918f 54868-2656 HUMAN OTC DRUG PanOxyl benzoyl peroxide SOAP TOPICAL 20080331 OTC MONOGRAPH NOT FINAL part333D Physicians Total Care, Inc. BENZOYL PEROXIDE 11.3 g/1 E 20171231 54868-2679_abda8405-5e00-46b9-aa1e-742743e5a3e0 54868-2679 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19990219 ANDA ANDA073281 Physicians Total Care, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-2683_3b12fe4e-f2ae-4555-b55d-822cd85e8d08 54868-2683 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19950502 ANDA ANDA073665 Physicians Total Care, Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 54868-2702_89977ac0-499f-427b-9c6f-3600f6ac5319 54868-2702 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20041116 NDA NDA004782 Physicians Total Care, Inc. ESTROGENS, CONJUGATED .3 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] E 20171231 54868-2711_5f4d49a9-41e2-4177-8c12-9772dd905a51 54868-2711 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET, EXTENDED RELEASE ORAL 19950118 ANDA ANDA040009 Physicians Total Care, Inc. ISOSORBIDE DINITRATE 40 mg/1 E 20171231 54868-2742_01e5c83f-f5a7-413f-953b-4cf3a41135bf 54868-2742 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE DENTAL 20030903 ANDA ANDA070730 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-2746_3457b3b5-976d-4240-bfad-e448294ec9cb 54868-2746 HUMAN OTC DRUG Humalog 70/30 Insulin human INJECTION, SUSPENSION SUBCUTANEOUS 19941228 NDA NDA019717 Physicians Total Care, Inc. INSULIN HUMAN 100 [iU]/mL E 20171231 54868-2762_94248b05-cdeb-47d3-b656-d6a8a2864ba9 54868-2762 HUMAN PRESCRIPTION DRUG Ritalin methylphenidate hydrochloride TABLET ORAL 20000310 NDA NDA010187 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-2782_493a8c42-16da-4710-9357-a46cd501377f 54868-2782 HUMAN PRESCRIPTION DRUG Ciloxan ciprofloxacin hydrochloride SOLUTION OPHTHALMIC 19950710 NDA NDA019992 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-2803_fb93a612-3a73-4e60-8567-4c971c67804e 54868-2803 HUMAN PRESCRIPTION DRUG Transderm Scop scopolamine PATCH, EXTENDED RELEASE TRANSDERMAL 20071002 NDA NDA017874 Physicians Total Care, Inc. SCOPOLAMINE 1 mg/3d Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 54868-2804_0f1ad27b-69a7-49e2-bab8-c520474fec26 54868-2804 HUMAN PRESCRIPTION DRUG EpiPen epinephrine INJECTION INTRAMUSCULAR 20030617 NDA NDA019430 Physicians Total Care, Inc. EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 54868-2817_53d395c2-3b12-4506-8400-6229df831c89 54868-2817 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20090422 ANDA ANDA086841 Physicians Total Care, Inc. DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] E 20171231 54868-2829_78562b23-7160-4e69-98ca-a2e2c5e5202a 54868-2829 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone GEL TOPICAL 20080229 ANDA ANDA074904 Physicians Total Care, Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-2834_55592f54-580b-4049-bbab-d82e7c3255a4 54868-2834 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19941209 ANDA ANDA073607 Physicians Total Care, Inc. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 54868-2835_34af46e3-e2c0-4360-ae01-f3d30d388a99 54868-2835 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20090609 ANDA ANDA073554 Physicians Total Care, inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-2840_776a59d7-9876-49e5-96c8-fe45230c6e49 54868-2840 HUMAN PRESCRIPTION DRUG Ery-Tab erythromycin TABLET, DELAYED RELEASE ORAL 20040630 ANDA ANDA062298 Physicians Total Care, Inc. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-2841_d2710544-16ee-4e77-9912-5e41355a9d30 54868-2841 HUMAN PRESCRIPTION DRUG Mycobutin rifabutin CAPSULE ORAL 19950315 NDA NDA050689 Physicians Total Care, Inc. RIFABUTIN 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 54868-2844_b0edb786-44c1-43ea-afc0-78df4970ce86 54868-2844 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19970326 ANDA ANDA040863 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-2847_8e359d73-d777-49d9-af50-724344f1a879 54868-2847 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide qinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20060803 ANDA ANDA078211 Physicians Total Care, Inc. QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 nmol/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-2860_27e21629-a817-4252-aa59-275b035ad251 54868-2860 HUMAN OTC DRUG Gas Relief Simethicone TABLET, CHEWABLE ORAL 19950517 OTC MONOGRAPH FINAL part332 Physicians Total Care, Inc. DIMETHICONE 80 mg/1 E 20171231 54868-2861_2834ef65-c3dc-40e8-a99f-998aa4706e81 54868-2861 HUMAN PRESCRIPTION DRUG Alclometasone Dipropionate Alclometasone Dipropionate CREAM TOPICAL 20090623 ANDA ANDA079061 Physicians Total Care, Inc. ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-2866_55592f54-580b-4049-bbab-d82e7c3255a4 54868-2866 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930928 ANDA ANDA073618 Physicians Total Care, Inc. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 54868-2875_4c539f04-059e-485a-8a8e-038ccb474b2b 54868-2875 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate SOLUTION TOPICAL 20020111 ANDA ANDA064159 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 54868-2876_dc8b1f98-70fd-475e-8b4b-84bc50a072e9 54868-2876 HUMAN PRESCRIPTION DRUG Myambutol Ethambutol hydrochloride TABLET ORAL 20070810 NDA NDA016320 Physicians Total Care, Inc. ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] E 20171231 54868-2877_ea6e8605-97f4-4667-8a19-2fb05b42faf1 54868-2877 HUMAN OTC DRUG Vitamin A and Vitamin D PETROLATUM OINTMENT TOPICAL 20060719 OTC MONOGRAPH FINAL part347 Physicians Total Care, Inc. PETROLATUM 929.3 mg/g E 20171231 54868-2887_df7bbf34-0dc4-41d3-b9be-22ad75bcbbe5 54868-2887 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 19941013 ANDA ANDA074749 Physicians Total Care, Inc. ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-2892_5e24193d-bc31-4e7d-b5a6-2815218cffd6 54868-2892 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20000209 ANDA ANDA087479 Physicians Total Care, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 54868-2893_b5f46d0d-6971-4954-96ca-01bd0faa52eb 54868-2893 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070917 ANDA ANDA086242 Physicians Total Care, Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 54868-2894_e150632a-d379-4a7a-9fd9-b4cb34fa3179 54868-2894 HUMAN PRESCRIPTION DRUG Fortamet metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20100218 NDA NDA021574 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-2898_2d8ef7bd-561e-4ed3-8ccb-07a92be6f964 54868-2898 HUMAN OTC DRUG Peptic Relief original strength Bismuth subsalicylate LIQUID ORAL 20081211 OTC MONOGRAPH FINAL part335 Physicians Total Care, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL E 20171231 54868-2913_9775e04f-8420-43ac-9a43-17d6bc263167 54868-2913 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20091015 ANDA ANDA088497 Physicians Total Care, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-2923_26d4b5e5-c715-4c55-b2fd-a51f9a3b1f5e 54868-2923 HUMAN OTC DRUG Glycerin Adult Glycerin SUPPOSITORY RECTAL 20101209 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. GLYCERIN 2 g/1 E 20171231 54868-2929_0d231e91-00f1-482d-aa82-01031de593af 54868-2929 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20050317 ANDA ANDA074046 Physicians Total Care, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-2930_0d231e91-00f1-482d-aa82-01031de593af 54868-2930 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20071026 ANDA ANDA074046 Physicians Total Care, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-2932_5939bdd8-49f6-4f94-8781-09992a046b69 54868-2932 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20080501 NDA NDA021992 Physicians Total Care, Inc. DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 54868-2971_774954ec-cef7-40a1-9eec-643fba420da2 54868-2971 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Neomycin and Polymyxin B Sulfates and Bacitracin Zinc OINTMENT OPHTHALMIC 19940325 ANDA ANDA064064 Physicians Total Care, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] E 20171231 54868-2972_676d3ac0-adfe-40ef-861b-c19680ab9ba3 54868-2972 HUMAN PRESCRIPTION DRUG TUBERSOL Tuberculin Purified Protein Derivative INJECTION, SOLUTION INTRADERMAL 19560815 BLA BLA103941 Physicians Total Care, Inc. TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU]/.1mL Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [Chemical/Ingredient] E 20171231 54868-2974_e6ce1d8c-e996-4b57-b6b3-3f312b449886 54868-2974 HUMAN PRESCRIPTION DRUG Methylphenidate methylphenidate hydrochloride TABLET ORAL 20071016 ANDA ANDA040220 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-2976_7b000f3a-baee-450d-ad32-851dbce53b05 54868-2976 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride TABLET, FILM COATED ORAL 20060918 NDA NDA020031 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-2984_3af42a6e-4178-482c-9e96-647e289d325a 54868-2984 HUMAN PRESCRIPTION DRUG MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate TABLET ORAL 19950424 NDA AUTHORIZED GENERIC NDA011839 Physicians Total Care, Inc. MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-2985_3af42a6e-4178-482c-9e96-647e289d325a 54868-2985 HUMAN PRESCRIPTION DRUG MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate TABLET ORAL 19950919 NDA AUTHORIZED GENERIC NDA011839 Physicians Total Care, Inc. MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-2989_01773720-eb77-4c73-880c-a727561fafc7 54868-2989 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19940105 ANDA ANDA077739 Physicians Total Care, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-2990_01773720-eb77-4c73-880c-a727561fafc7 54868-2990 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19941129 ANDA ANDA077739 Physicians Total Care, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-2994_ce005228-bed3-4940-831b-c7f8b8256d9f 54868-2994 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate OINTMENT TOPICAL 19970502 ANDA ANDA018865 Physicians Total Care, Inc. BETAMETHASONE VALERATE 1 mg/g E 20171231 54868-2996_b1e1c690-2ad8-453c-86c0-858cf3502952 54868-2996 HUMAN PRESCRIPTION DRUG METHAZOLAMIDE methazolamide TABLET ORAL 20061212 ANDA ANDA040036 Physicians Total Care, Inc. METHAZOLAMIDE 50 mg/1 E 20171231 54868-3004_6630c8a2-8c01-4ae7-a48d-0bf6ffd5b22a 54868-3004 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 19940426 ANDA ANDA075797 Physicians Total Care, Inc. TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 54868-3005_0d231e91-00f1-482d-aa82-01031de593af 54868-3005 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20060913 ANDA ANDA074046 Physicians Total Care, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-3006_b4deba09-9747-4145-bb8c-956ce26560ad 54868-3006 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20090417 ANDA ANDA072235 Physicians Total Care, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 54868-3023_bb001c15-9f5c-454e-b12d-e8664b16f80b 54868-3023 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide GEL TOPICAL 20040520 ANDA ANDA072537 Physicians Total Care, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3026_cb0651c6-180a-435f-a124-8e4d33c8a5ea 54868-3026 HUMAN OTC DRUG Natural Fiber Powder Smooth Texture PSYLLIUM HUSK GRANULE ORAL 20110331 OTC MONOGRAPH FINAL part334 Physicians Total Care, Inc. PSYLLIUM HUSK 3.4 g/100g E 20171231 54868-3041_fed9b9ba-de86-4c2e-a424-4d7db8b47bf3 54868-3041 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 19940623 ANDA ANDA073193 Physicians Total Care, Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3043_f379ec02-a978-4c53-a036-564f250ed3f8 54868-3043 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 19940114 ANDA ANDA078314 Physicians Total Care, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-3046_759ff775-6dc9-46c3-8a45-853f619c19ea 54868-3046 HUMAN OTC DRUG Hibiclens Chlorhexidine gluconate SOLUTION TOPICAL 20041117 NDA NDA017768 Physicians Total Care, Inc. CHLORHEXIDINE GLUCONATE 213 g/1000mL E 20171231 54868-3049_1322c2db-3238-4fbf-95b3-6e0b0c8ae7f1 54868-3049 HUMAN PRESCRIPTION DRUG Diflunisal Diflunisal TABLET, FILM COATED ORAL 20090721 ANDA ANDA073673 Physicians Total Care, Inc. DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-3050_9166ec18-da24-4f12-b446-dcf2dcc9d3ca 54868-3050 HUMAN PRESCRIPTION DRUG Neupogen filgrastim INJECTION, SOLUTION INTRAVENOUS 20060814 BLA BLA103353 Physicians Total Care, Inc. FILGRASTIM 480 ug/.8mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] E 20171231 54868-3059_278a4c28-41eb-4894-9275-a793d1805ba0 54868-3059 HUMAN PRESCRIPTION DRUG Clomiphene Citrate Clomiphene Citrate TABLET ORAL 19960822 ANDA ANDA075528 Physicians Total Care, Inc. CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 54868-3062_59a95728-34a6-4741-8807-cba7da17e1ab 54868-3062 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070924 ANDA ANDA078332 Physicians Total Care, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 54868-3064_3b12fe4e-f2ae-4555-b55d-822cd85e8d08 54868-3064 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 20050505 ANDA ANDA073665 Physicians Total Care, Inc. ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 54868-3068_e58a7f34-4791-4ebb-b13a-75caf23f0f8d 54868-3068 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20030807 ANDA ANDA072640 Physicians Total Care, Inc. CLOTRIMAZOLE 10 mg/g E 20171231 54868-3071_a830869a-cacf-4e78-a721-42d550944704 54868-3071 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20090511 NDA NDA018074 Physicians Total Care, Inc. PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII E 20171231 54868-3086_66ea5793-f691-4217-9a37-39690a7a3f69 54868-3086 HUMAN PRESCRIPTION DRUG Multaq Dronedarone TABLET, FILM COATED ORAL 20100223 NDA NDA022425 Physicians Total Care, Inc. DRONEDARONE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-3089_6c1f2ad3-c872-440f-99d5-8201a5af54a8 54868-3089 HUMAN PRESCRIPTION DRUG Dextrose Dextrose INJECTION, SOLUTION INTRAVENOUS 20061211 NDA NDA019445 Physicians Total Care, Inc. DEXTROSE MONOHYDRATE 25 g/50mL E 20171231 54868-3097_740bcab1-830a-46c1-afa8-c71191d1b9b7 54868-3097 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide LOTION TOPICAL 20050126 ANDA ANDA088451 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3101_fea217d1-9c40-49b9-9731-0227fcbf74b7 54868-3101 HUMAN PRESCRIPTION DRUG Lactulose lactulose SOLUTION ORAL 20040419 ANDA ANDA074623 Physicians Total Care, Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 54868-3103_e5f3b0c9-1c83-47b1-8de0-375ea9719d22 54868-3103 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20001114 NDA AUTHORIZED GENERIC NDA020401 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-3105_48ab8ad9-6a35-4696-a79b-7a8aed5f3c5a 54868-3105 HUMAN PRESCRIPTION DRUG Amoxicillin amoxicillin TABLET, CHEWABLE ORAL 20040601 ANDA ANDA065021 Physicians Total Care, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-3107_db05df82-8297-4bea-9036-dc5d651cac72 54868-3107 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20031029 ANDA ANDA064076 Physicians Total Care, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-3109_db05df82-8297-4bea-9036-dc5d651cac72 54868-3109 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Physicians Total Care, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-3110_51046537-1147-43b7-9b0a-140919c1453b 54868-3110 HUMAN PRESCRIPTION DRUG METROGEL metronidazole GEL VAGINAL 19941219 NDA NDA020208 Physicians Total Care, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 54868-3112_abe66794-692f-4b30-86d3-bdfc64f4f8f1 54868-3112 HUMAN PRESCRIPTION DRUG Prochlorperazine Prochlorperazine SUPPOSITORY RECTAL 20010720 ANDA ANDA040058 Physicians Total Care, Inc. PROCHLORPERAZINE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-3113_968da774-da92-4eed-bfb1-ae2a68b2d94e 54868-3113 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 20110322 ANDA ANDA064082 Physicians Total Care, Inc. AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-3114_210798f9-c1d1-4c6b-bfe9-06c02c801234 54868-3114 HUMAN PRESCRIPTION DRUG Estropipate estropipate TABLET ORAL 20030321 ANDA ANDA081213 Physicians Total Care, Inc. ESTROPIPATE .75 mg/1 E 20171231 54868-3115_5192b19b-5bd1-4f62-9cad-b120de7dbb74 54868-3115 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal Delivery System nitroglycerin PATCH TRANSDERMAL 20060530 ANDA ANDA089771 Physicians Total Care, Inc. NITROGLYCERIN 2.5 mg/d Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 54868-3129_62e47df3-814e-499f-b949-843e852b358d 54868-3129 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION OPHTHALMIC 20050620 ANDA ANDA088771 Physicians Total Care, Inc. DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3134_d89a9f8c-c600-436b-97e7-ed8c54d42aff 54868-3134 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 20090909 NDA NDA016694 Physicians Total Care, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 54868-3137_69c62db2-25f0-4f7e-937d-8a52e457ee49 54868-3137 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET ORAL 20080606 ANDA ANDA077290 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-3155_5264120b-3fa4-42c6-a517-1d1abc71421a 54868-3155 HUMAN OTC DRUG Dulcolax Bisacodyl SUPPOSITORY RECTAL 20110317 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. BISACODYL 10 mg/1 E 20171231 54868-3157_537cd838-05f2-44f4-aeb2-89c42f153e3c 54868-3157 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20050621 ANDA ANDA087916 Physicians Total Care, Inc DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3165_e387fd18-7c90-431b-8e9b-b381edb43c49 54868-3165 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, FILM COATED ORAL 20040920 ANDA ANDA078273 Physicians Total Care, Inc. HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-3169_77fd8181-dd74-490f-9eab-e6c47573309b 54868-3169 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19940801 ANDA ANDA062031 Physicians Total Care, Inc. DOXYCYCLINE HYCLATE 50 mg/1 E 20171231 54868-3180_d88cd7d7-60a1-48df-b426-40b37fa732f0 54868-3180 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate INJECTION SUBCUTANEOUS 19950126 NDA NDA020080 Physicians Total Care, Inc. SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 54868-3191_faad3ce3-e3a8-415b-9396-d22c840fab0d 54868-3191 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080107 NDA NDA022207 Physicians Total Care, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-3216_3267cd9b-c7c6-4b6d-8e67-1e656972d5d0 54868-3216 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride SOLUTION ORAL 20050223 ANDA ANDA075060 Physicians Total Care, Inc. AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] E 20171231 54868-3230_2ed9b59c-40be-4140-aa8e-1584dcd09329 54868-3230 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19940411 NDA NDA021171 Physicians Total Care, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-3250_a5f505d5-486e-446c-bc02-ac4f482bf5b7 54868-3250 HUMAN PRESCRIPTION DRUG Neomycin, Polymyxin B Sulfates and Hydrocortisone Neomycin, Polymyxin B Sulfates and Hydrocortisone SUSPENSION OPHTHALMIC 19940407 ANDA ANDA062423 Physicians Total Care, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 100 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3257_8b910c5e-691b-492d-95df-bb01fd6b0c4f 54868-3257 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 20100114 ANDA ANDA074172 Physicians Total Care, Inc. NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-3265_49f0ce6f-5305-41c2-8afe-eed1870459b8 54868-3265 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19940426 ANDA ANDA076257 Physicians Total Care, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-3266_49f0ce6f-5305-41c2-8afe-eed1870459b8 54868-3266 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19940826 ANDA ANDA076257 Physicians Total Care, Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-3267_e20a1904-ff41-4b58-83b3-74318c3a64ee 54868-3267 HUMAN OTC DRUG Acetaminophen infants Acetaminophen SUSPENSION/ DROPS ORAL 19940513 OTC MONOGRAPH NOT FINAL part343 Physicians Total Care, Inc. ACETAMINOPHEN 80 mg/.8mL E 20171231 54868-3269_5b3bcf88-28c0-4266-b26e-9a5156bb7a9f 54868-3269 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 19790822 OTC MONOGRAPH FINAL part333B Physicians Total Care, Inc. BACITRACIN 500 [USP'U]/g E 20171231 54868-3280_66df8564-8239-4078-ba9a-35a11cfb36e7 54868-3280 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 19940427 ANDA ANDA019141 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3283_ff09d876-3fc3-4826-b04b-f600a4cfba83 54868-3283 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 20001205 NDA NDA020829 Physicians Total Care, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 54868-3284_86025f14-dda5-4c28-bbe1-bafa3f511119 54868-3284 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 20060411 NDA NDA017010 Physicians Total Care, Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3287_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-3287 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20090415 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-3300_5651bc48-1227-4ca9-aaf9-805771c27090 54868-3300 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960115 ANDA ANDA074587 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-3310_d67caab0-2ebd-4d80-a415-2e329fb5a34e 54868-3310 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 20020415 ANDA ANDA072733 Physicians Total Care, Inc. LEUCOVORIN CALCIUM 5 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 54868-3314_13f68ac1-1bb6-45d1-acee-124b56a1fae8 54868-3314 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 19940622 ANDA ANDA074424 Physicians Total Care, Inc. CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 54868-3315_13f68ac1-1bb6-45d1-acee-124b56a1fae8 54868-3315 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 19940725 ANDA ANDA074424 Physicians Total Care, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 54868-3316_13f68ac1-1bb6-45d1-acee-124b56a1fae8 54868-3316 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 19940523 ANDA ANDA074424 Physicians Total Care, Inc. CIMETIDINE 800 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 54868-3318_df0a1559-aa16-4126-b4c1-fd51aa19c2c7 54868-3318 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19940726 ANDA ANDA074223 Physicians Total Care, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-3319_df0a1559-aa16-4126-b4c1-fd51aa19c2c7 54868-3319 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19941118 ANDA ANDA074223 Physicians Total Care, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-3327_b2688fe1-f2f1-4c67-8420-0647a0ff0694 54868-3327 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051020 ANDA ANDA076802 Physicians Total Care, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-3329_ef0d7cf5-ed4e-47ea-8c4c-8426e03e7c82 54868-3329 HUMAN PRESCRIPTION DRUG LESCOL fluvastatin sodium CAPSULE ORAL 19940610 NDA NDA020261 Physicians Total Care, Inc. FLUVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-3334_71c99c7c-76eb-425c-83d9-880c78c935a6 54868-3334 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 19940930 NDA NDA020329 Physicians Total Care, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-3335_71c99c7c-76eb-425c-83d9-880c78c935a6 54868-3335 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 19940801 NDA NDA020329 Physicians Total Care, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-3348_3737b5dd-6816-4df6-ad81-761eae67918e 54868-3348 HUMAN PRESCRIPTION DRUG Depo-Provera medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19950113 NDA NDA012541 Physicians Total Care, Inc. MEDROXYPROGESTERONE ACETATE 400 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-3362_805932c3-0a3a-4eac-a6ab-9b8cca1929bd 54868-3362 HUMAN PRESCRIPTION DRUG Flurbiprofen flurbiprofen TABLET, FILM COATED ORAL 19970224 ANDA ANDA074358 Physicians Total Care, Inc. FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-3363_46bb62bb-de08-4317-8dd3-b5c911b8e3cc 54868-3363 HUMAN PRESCRIPTION DRUG Levobunolol Hydrochloride Levobunolol Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19950223 ANDA ANDA074326 Physicians Total Care, Inc. LEVOBUNOLOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-3377_b2688fe1-f2f1-4c67-8420-0647a0ff0694 54868-3377 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051019 ANDA ANDA076802 Physicians Total Care, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-3384_035934ee-0466-4e9f-b15d-1eba7aa748d2 54868-3384 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin GRANULE, FOR SUSPENSION ORAL 20070501 NDA NDA050698 Physicians Total Care, Inc. CLARITHROMYCIN 250 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-3388_11c40932-8c8f-4a48-8b1f-c0fa4c7dbaa7 54868-3388 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20050404 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-3390_54642793-18db-4fca-9056-a2ca5a740e59 54868-3390 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 19941006 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-3399_d975e88b-476c-463b-9600-3fbcdb0e86f2 54868-3399 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20001121 NDA NDA009218 Physicians Total Care, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-3405_b4deba09-9747-4145-bb8c-956ce26560ad 54868-3405 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100305 ANDA ANDA072234 Physicians Total Care, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 54868-3407_1c40dbf2-4ce1-47e0-9425-a246e9fdc9bc 54868-3407 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19941019 ANDA ANDA074543 Physicians Total Care, Inc. ALBUTEROL SULFATE 5 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-3408_a87f96f5-e6c3-40c5-b587-4d4fc917c46c 54868-3408 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 NDA NDA019117 Physicians Total Care, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3423_fde0098f-69a8-4e16-8c8e-b73786aaa9e5 54868-3423 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20100119 ANDA ANDA077519 Physicians Total Care, Inc. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3426_49f0ce6f-5305-41c2-8afe-eed1870459b8 54868-3426 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19941118 ANDA ANDA076257 Physicians Total Care, Inc. GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-3435_bb001c15-9f5c-454e-b12d-e8664b16f80b 54868-3435 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide OINTMENT TOPICAL 19941122 ANDA ANDA073481 Physicians Total Care, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3437_d89a9f8c-c600-436b-97e7-ed8c54d42aff 54868-3437 HUMAN PRESCRIPTION DRUG Marcaine BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION 20090908 NDA NDA016964 Physicians Total Care, Inc. BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 54868-3438_d89a9f8c-c600-436b-97e7-ed8c54d42aff 54868-3438 HUMAN PRESCRIPTION DRUG Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION 20100506 NDA NDA016964 Physicians Total Care, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 54868-3439_d89a9f8c-c600-436b-97e7-ed8c54d42aff 54868-3439 HUMAN PRESCRIPTION DRUG Marcaine with Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION 20100510 NDA NDA016964 Physicians Total Care, Inc. BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 5; .0091 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 54868-3454_d0a1c04b-91eb-4751-8e42-89e3c4d323d6 54868-3454 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 19941216 ANDA ANDA086428 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-3457_943adc58-3c44-4b5e-b7da-20d4b550a65b 54868-3457 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 19951227 ANDA ANDA040597 Physicians Total Care, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 54868-3465_e4403738-ddcb-4f9b-80c3-2e1ac9d61bde 54868-3465 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20021016 ANDA ANDA071344 Physicians Total Care, Inc. MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 54868-3467_e4403738-ddcb-4f9b-80c3-2e1ac9d61bde 54868-3467 HUMAN PRESCRIPTION DRUG MINOXIDIL Minoxidil TABLET ORAL 19960913 ANDA ANDA071345 Physicians Total Care, Inc. MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 54868-3474_f8f7bdaf-47bb-43bc-8696-a6b844e21933 54868-3474 HUMAN OTC DRUG Novolin 70/30 Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 19950111 NDA NDA019991 Physicians Total Care, Inc. INSULIN HUMAN 100 [USP'U]/mL E 20171231 54868-3478_c1c22706-36a7-47b4-97e4-3ad4c67ea753 54868-3478 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 19960124 ANDA ANDA064156 Physicians Total Care, Inc. CEFACLOR 250 mg/1 E 20171231 54868-3511_c1c22706-36a7-47b4-97e4-3ad4c67ea753 54868-3511 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 19950405 ANDA ANDA064156 Physicians Total Care, Inc. CEFACLOR 500 mg/1 E 20171231 54868-3524_b11256fa-aab4-452f-83e4-4447fdbd63e7 54868-3524 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate gentamicin sulfate CREAM TOPICAL 19950512 ANDA ANDA062307 Physicians Total Care, Inc. GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 54868-3526_7b000f3a-baee-450d-ad32-851dbce53b05 54868-3526 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride TABLET, FILM COATED ORAL 19960710 NDA NDA020031 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-3533_21a83a08-cb04-448b-9897-83ec9538c9c2 54868-3533 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20070801 ANDA ANDA071669 Physicians Total Care, Inc. DOXEPIN HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-3550_fde0098f-69a8-4e16-8c8e-b73786aaa9e5 54868-3550 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20090204 ANDA ANDA077519 Physicians Total Care, Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3559_cae8fb46-3120-4ddb-9cbf-649e5cae5a73 54868-3559 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride INJECTION INTRAMUSCULAR 20100304 ANDA ANDA080455 Physicians Total Care, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-3566_d2cde812-4f5e-41ce-9ee2-e144b36a4e5f 54868-3566 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070110 ANDA ANDA074300 Physicians Total Care, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-3584_23a906da-21fa-4ac7-9097-95af783b7723 54868-3584 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 19970502 ANDA ANDA074220 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3618_85571ab6-b0f5-4f49-b883-499ec60aaaed 54868-3618 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20070810 ANDA ANDA040530 Physicians Total Care, Inc. TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 54868-3619_5ace7bf4-ae3d-4cc5-b5b6-a171d26d82a2 54868-3619 HUMAN OTC DRUG Humulin R Insulin human INJECTION, SOLUTION SUBCUTANEOUS 19950727 NDA NDA018780 Physicians Total Care, Inc. INSULIN HUMAN 100 [iU]/mL E 20171231 54868-3632_bd26a0a2-2f4c-47ae-948f-e6868ac91132 54868-3632 HUMAN PRESCRIPTION DRUG LITHIUM CARBONATE Lithium Carbonate CAPSULE ORAL 20051205 ANDA ANDA090702 Physicians Total Care, Inc. LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] E 20171231 54868-3648_db900408-b413-4795-9749-e75a8a53d1c5 54868-3648 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 19950815 ANDA ANDA065212 Physicians Total Care, Inc. AZITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-3655_10e3f643-f415-4646-bb59-60ca369f9bb2 54868-3655 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20100304 NDA NDA021977 Physicians Total Care, Inc. LISDEXAMFETAMINE DIMESYLATE 70 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-3659_76eaad99-62c9-4c09-b22e-36e7e10a1265 54868-3659 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19951116 ANDA ANDA074376 Physicians Total Care, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-3669_f1bd3dd6-7d12-48fa-87a8-820762c54f27 54868-3669 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20060810 ANDA ANDA040615 Physicians Total Care, Inc. TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 54868-3671_e1f4e093-cf3f-4ce0-ba22-3fc5f3c4251c 54868-3671 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20041217 ANDA ANDA075604 Physicians Total Care, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-3690_55fc05f3-675b-4ab1-97f1-e6a3c1482245 54868-3690 HUMAN PRESCRIPTION DRUG Lotensin Benazepril Hydrochloride TABLET ORAL 19961230 NDA NDA019851 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-3693_4062960e-f215-4ffd-a79e-241c34a67746 54868-3693 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 19951201 NDA NDA020564 Physicians Total Care, Inc. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 54868-3695_3d6a40a1-b103-4636-b143-6119ff16803a 54868-3695 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970227 ANDA ANDA062801 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 54868-3698_58d0c66a-8d8b-432c-ada7-dac055230fce 54868-3698 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20050302 ANDA ANDA074248 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-3713_8459e88b-78ab-4eb8-80ed-e56ada9535ee 54868-3713 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 19960126 ANDA ANDA074261 Physicians Total Care, Inc. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-3714_8459e88b-78ab-4eb8-80ed-e56ada9535ee 54868-3714 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 19950126 ANDA ANDA074262 Physicians Total Care, Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-3722_e568b860-2272-4a94-8f4d-095cda3be647 54868-3722 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 19980324 ANDA ANDA077789 Physicians Total Care, Inc. CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] E 20171231 54868-3724_fa5809cd-a0d0-4ff6-a902-cb8a2e1c60f6 54868-3724 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960425 ANDA ANDA074505 Physicians Total Care, Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-3725_fa5809cd-a0d0-4ff6-a902-cb8a2e1c60f6 54868-3725 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960805 ANDA ANDA074505 Physicians Total Care, Inc. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-3726_60b11c09-e7ec-4f59-97b9-8a4237840578 54868-3726 HUMAN PRESCRIPTION DRUG Cozaar losartan potassium TABLET, FILM COATED ORAL 19960401 NDA NDA020386 Physicians Total Care, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-3732_9f789e65-2050-42ea-9b06-6adee341edd6 54868-3732 HUMAN PRESCRIPTION DRUG MEBENDAZOLE mebendazole TABLET, CHEWABLE ORAL 19960404 ANDA ANDA073580 Physicians Total Care, Inc. MEBENDAZOLE 100 mg/1 Antihelminthic [EPC] E 20171231 54868-3735_eee48d18-28a7-4ac9-92b8-3e6f738223f3 54868-3735 HUMAN PRESCRIPTION DRUG Carafate Sucralfate SUSPENSION ORAL 19960312 NDA NDA019183 Physicians Total Care, Inc. SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] E 20171231 54868-3742_c0fa3fe4-2403-4a8d-a41a-d812a552d0b8 54868-3742 HUMAN PRESCRIPTION DRUG Cefadroxil cefadroxil hemihydrate CAPSULE ORAL 19960423 ANDA ANDA065015 Physicians Total Care, Inc. CEFADROXIL HEMIHYDRATE 500 mg/1 E 20171231 54868-3757_02247f29-7afe-46dd-a5f6-ef8f8eeec7a3 54868-3757 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate SOLUTION TOPICAL 20060330 ANDA ANDA075919 Physicians Total Care, Inc. MOMETASONE FUROATE 1 mg/mL E 20171231 54868-3764_39d05358-adcf-48a9-ad87-39e05d1fe577 54868-3764 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20090216 ANDA ANDA074700 Physicians Total Care, Inc. BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 54868-3765_39d05358-adcf-48a9-ad87-39e05d1fe577 54868-3765 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20001129 ANDA ANDA074700 Physicians Total Care, Inc. BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 54868-3781_fe4870ed-c2d6-45f1-b69c-959667ab2e83 54868-3781 HUMAN OTC DRUG Minoxidil minoxidil SOLUTION TOPICAL 19960604 ANDA ANDA074588 Physicians Total Care, Inc. MINOXIDIL 2 g/100mL E 20171231 54868-3799_28327f6d-9226-4266-bfb2-7a89715a978b 54868-3799 HUMAN PRESCRIPTION DRUG Prempro conjugated estrogens and medroxyprogesterone acetate TABLET, SUGAR COATED ORAL 19960620 NDA NDA020527 Physicians Total Care, Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .625; 2.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-3800_cd8751c0-81b3-4fc4-84bf-1f84e0a827b5 54868-3800 HUMAN PRESCRIPTION DRUG Premphase conjugated estrogens and medroxyprogesterone acetate KIT 20050708 ANDA ANDA075796 Physicians Total Care, Inc. E 20171231 54868-3801_53d395c2-3b12-4506-8400-6229df831c89 54868-3801 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20051216 ANDA ANDA086842 Physicians Total Care, Inc. DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] E 20171231 54868-3821_17a5d335-2026-40d5-8c4d-b6522c0dc1e4 54868-3821 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 19960709 ANDA ANDA040766 Physicians Total Care, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] E 20171231 54868-3826_1856dd9e-177f-42a2-99f5-4ca56c727f27 54868-3826 HUMAN PRESCRIPTION DRUG Methotrexate Sodium methotrexate sodium TABLET ORAL 20071205 ANDA ANDA081099 Physicians Total Care, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 54868-3832_185df2c5-c212-46fc-9697-f1185fa23ff9 54868-3832 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20021024 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ACETAMINOPHEN 500 mg/1 E 20171231 54868-3835_f1bacd71-d3dc-44ac-aa69-ea49bbf77be5 54868-3835 HUMAN PRESCRIPTION DRUG Demadex Torsemide TABLET ORAL 20001128 NDA NDA020136 Physicians Total Care, Inc. TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 54868-3837_76eaad99-62c9-4c09-b22e-36e7e10a1265 54868-3837 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19970210 ANDA ANDA074394 Physicians Total Care, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-3849_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-3849 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 19960829 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-3854_8631cd71-b034-4a99-9683-f13a37940462 54868-3854 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20050516 ANDA ANDA077856 Physicians Total Care, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-3855_8631cd71-b034-4a99-9683-f13a37940462 54868-3855 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20030925 ANDA ANDA077856 Physicians Total Care, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-3857_f7eed7fa-4c6f-4dfc-836d-4b8333aee0d3 54868-3857 HUMAN PRESCRIPTION DRUG Fosamax alendronate sodium TABLET, COATED ORAL 19961219 NDA NDA020560 Physicians Total Care, Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 54868-3861_8631cd71-b034-4a99-9683-f13a37940462 54868-3861 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20090626 ANDA ANDA077856 Physicians Total Care, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-3867_183fd856-868e-459a-8361-66ca5ac363e3 54868-3867 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 20001128 NDA NDA020406 Physicians Total Care, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 54868-3873_97c22a3f-3b58-4e79-8e94-0582cca3e761 54868-3873 HUMAN PRESCRIPTION DRUG Propranolol Propranolol INJECTION INTRAVENOUS 20061211 ANDA ANDA077760 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-3906_2d55557e-ec94-4ae4-aa0b-f35df835b961 54868-3906 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20041028 ANDA ANDA076631 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-3923_3e9b0b41-65ab-47e1-8790-cccf368f68aa 54868-3923 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 20000511 NDA NDA020634 Physicians Total Care, Inc. LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-3933_63f2458b-4cf0-493f-aab4-56e964febd24 54868-3933 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20050523 ANDA ANDA070848 Physicians Total Care, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] E 20171231 54868-3934_2785c2fd-f22a-43aa-a781-e1218be9a70c 54868-3934 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19970505 NDA NDA020702 Physicians Total Care, Inc ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-3935_c30dce9a-8324-4d63-970d-c3087d10cc98 54868-3935 HUMAN PRESCRIPTION DRUG Promethazine VC Promethazine Hydrochloride and Phenylephrine Hydrochloride SYRUP ORAL 20000906 ANDA ANDA040654 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 5 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] E 20171231 54868-3941_ab9d67ba-3e66-4664-a376-b65a4bfa7331 54868-3941 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20030620 NDA NDA020592 Physicians Total Care, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-3946_2785c2fd-f22a-43aa-a781-e1218be9a70c 54868-3946 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20040312 NDA NDA020702 Physicians Total Care, Inc ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-3952_d76dc06e-e796-414c-87b3-0bf34fce34fc 54868-3952 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 20080509 NDA NDA020690 Physicians Total Care, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 54868-3955_14d86267-3396-4311-9f0b-64fe41fbb8cb 54868-3955 HUMAN PRESCRIPTION DRUG Etodolac etodolac TABLET, FILM COATED ORAL 20000117 ANDA ANDA075074 Physicians Total Care, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-3974_27b8ca7e-1ac6-4b19-924a-2a0d45a76ca1 54868-3974 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050819 NDA NDA020353 Physicians Total Care, Inc. NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-3993_c22fa6a5-8dce-49ea-8512-0bffb3e6fcd9 54868-3993 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 20030425 NDA NDA020487 Physicians Total Care, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 54868-3996_2c6f7dc5-0214-4014-899a-d2700fc942af 54868-3996 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir CAPSULE ORAL 19980727 ANDA ANDA074727 Physicians Total Care, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 54868-3997_2c6f7dc5-0214-4014-899a-d2700fc942af 54868-3997 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 19981117 ANDA ANDA075211 Physicians Total Care, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 54868-3998_2c6f7dc5-0214-4014-899a-d2700fc942af 54868-3998 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 19981117 ANDA ANDA075211 Physicians Total Care, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 54868-3999_76eaad99-62c9-4c09-b22e-36e7e10a1265 54868-3999 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20040521 ANDA ANDA074376 Physicians Total Care, Inc. DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-4021_230ef06f-75a4-4bc7-942c-63ab2c7cbec8 54868-4021 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride Promethazine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20000229 ANDA ANDA040737 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-4023_5f25943a-b546-481f-8076-f6fc391a0c9e 54868-4023 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 20050928 ANDA ANDA074694 Physicians Total Care, Inc. CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 54868-4030_4bf65206-846b-4dbb-898e-44c9add76830 54868-4030 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20000918 ANDA ANDA040197 Physicians Total Care, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-4031_4bf65206-846b-4dbb-898e-44c9add76830 54868-4031 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20030507 ANDA ANDA040197 Physicians Total Care, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-4033_c50edaa2-4f73-4ed5-a237-752242c00736 54868-4033 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20050630 ANDA ANDA075295 Physicians Total Care, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-4034_1e359210-b96e-42d3-82f0-dfb8ae2ab152 54868-4034 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitatrate and Acetaminophen TABLET ORAL 19980513 ANDA ANDA040148 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 54868-4035_88ef85b9-192f-4f88-9e51-7e0bd588dc35 54868-4035 HUMAN PRESCRIPTION DRUG Vicoprofen Hydrocodone Bitartrate and Ibuprofen TABLET, COATED ORAL 19980513 NDA NDA020716 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII E 20171231 54868-4045_626db41f-f2a3-4f12-b0d1-40e354e1ec5b 54868-4045 HUMAN PRESCRIPTION DRUG NECON 1/35 Norethindrone and Ethinyl Estradiol KIT 20010810 ANDA ANDA070687 Physicians Total Care, Inc. E 20171231 54868-4048_97338446-4ae1-4e44-a353-171793776da0 54868-4048 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 19990921 ANDA ANDA075208 Physicians Total Care, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 54868-4051_e78bcfe3-cc0f-4c23-8e5c-6d58d3837fbd 54868-4051 HUMAN PRESCRIPTION DRUG Naproxen naproxen TABLET, DELAYED RELEASE ORAL 20020111 ANDA ANDA075390 Physicians Total Care, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-4055_ea19bd36-7cb9-4836-b1f3-a2b6c852906e 54868-4055 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20070719 ANDA ANDA078627 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4059_14d86267-3396-4311-9f0b-64fe41fbb8cb 54868-4059 HUMAN PRESCRIPTION DRUG Etodolac etodolac TABLET, FILM COATED ORAL 19990421 ANDA ANDA075074 Physicians Total Care, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-4062_16c2a7ef-99f3-4b11-a4fd-a90471a7fddf 54868-4062 HUMAN PRESCRIPTION DRUG Captopril and Hydrochlorothiazide Captopril and Hydrochlorothiazide TABLET ORAL 20031007 ANDA ANDA074896 Physicians Total Care, Inc. CAPTOPRIL; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4066_8a1277c4-9a11-4cc9-8a6b-aea181d8c75c 54868-4066 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20050202 NDA NDA020364 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-4070_531ec738-92ae-4fd2-bf93-27bd9d9ad30d 54868-4070 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 20001121 NDA NDA020839 Physicians Total Care, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 54868-4073_8a1277c4-9a11-4cc9-8a6b-aea181d8c75c 54868-4073 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19990701 NDA NDA020364 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-4074_8a1277c4-9a11-4cc9-8a6b-aea181d8c75c 54868-4074 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20001128 NDA NDA020364 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-4079_183fd856-868e-459a-8361-66ca5ac363e3 54868-4079 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 20000830 NDA NDA020406 Physicians Total Care, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 54868-4082_e1df8f23-3109-4abe-8d78-afc36e64efc4 54868-4082 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 19981203 ANDA ANDA074755 Physicians Total Care, Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 54868-4084_40d47894-7517-49bd-a937-80b5b5217b0d 54868-4084 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Physicians Total Care, Inc. SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 54868-4087_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4087 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20030620 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-4091_eb12bd6a-9815-4687-8ac7-0bb533fe0137 54868-4091 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19990224 ANDA ANDA074686 Physicians Total Care, Inc. GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-4092_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4092 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20021115 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-4093_61e4740e-ec39-4bcf-9aad-62ca54ce9ac5 54868-4093 HUMAN PRESCRIPTION DRUG Ortho Tri Cyclen norgestimate and ethinyl estradiol KIT 20050513 NDA NDA021690 Physicians Total Care, Inc. E 20171231 54868-4095_943821b5-8382-43e2-a18b-ac8e9cde746e 54868-4095 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020411 ANDA ANDA040256 Physicians Total Care, Inc. PREDNISONE 10 mg/1 E 20171231 54868-4096_997397d5-0c64-459e-88f3-d8c289b37367 54868-4096 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20021127 ANDA ANDA040256 Physicians Total Care, Inc. PREDNISONE 5 mg/1 E 20171231 54868-4101_f61d812f-ef18-4c0e-8908-2e493535b4fd 54868-4101 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Physicians Total Care, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-4102_712d75b9-67f4-4009-9c9e-8a9512b167e8 54868-4102 HUMAN PRESCRIPTION DRUG ORPHENADRINE CITRATE orphenadrine citrate TABLET, EXTENDED RELEASE ORAL 20000417 ANDA ANDA040284 Physicians Total Care, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 54868-4107_f61d812f-ef18-4c0e-8908-2e493535b4fd 54868-4107 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Physicians Total Care, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-4120_6e754587-6d53-44b1-a260-8ddc944d33a0 54868-4120 HUMAN PRESCRIPTION DRUG PROPECIA finasteride TABLET, FILM COATED ORAL 19971219 NDA NDA020788 Physicians Total Care, Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 54868-4125_9185f276-5046-4707-9287-6c4662b1c18f 54868-4125 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19920419 ANDA ANDA060456 Physicians Total Care, Inc. PENICILLIN V POTASSIUM 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-4126_1e5cfbbe-db3d-4aa9-bb52-ab6e5afe299c 54868-4126 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20050509 ANDA ANDA019049 Physicians Total Care, Inc. TRETINOIN .025 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-4134_212beee0-c44a-465a-8113-7c1f004cb40d 54868-4134 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20040504 ANDA ANDA075491 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 54868-4135_14d86267-3396-4311-9f0b-64fe41fbb8cb 54868-4135 HUMAN PRESCRIPTION DRUG Etodolac etodolac CAPSULE ORAL 20100331 ANDA ANDA075078 Physicians Total Care, Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-4142_cef15d8b-d8c6-491e-9549-695ddc33892b 54868-4142 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 20050629 NDA NDA021029 Physicians Total Care, Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 54868-4143_16881b74-dac8-403b-8a75-b1ca2732ab11 54868-4143 HUMAN PRESCRIPTION DRUG Xeloda capecitabine TABLET, FILM COATED ORAL 20050220 NDA NDA020896 Physicians Total Care, Inc. CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 54868-4146_40b8f8d9-52b7-43d7-9cdc-10b36cc92bfe 54868-4146 HUMAN PRESCRIPTION DRUG Lidoderm lidocaine PATCH CUTANEOUS 20030505 NDA NDA020612 Physicians Total Care, Inc. LIDOCAINE 700 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 54868-4149_210798f9-c1d1-4c6b-bfe9-06c02c801234 54868-4149 HUMAN PRESCRIPTION DRUG Estropipate estropipate TABLET ORAL 20030321 ANDA ANDA081214 Physicians Total Care, Inc. ESTROPIPATE 1.5 mg/1 E 20171231 54868-4150_db05df82-8297-4bea-9036-dc5d651cac72 54868-4150 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20041124 ANDA ANDA065387 Physicians Total Care, Inc. AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-4151_1c06a8e7-2281-4118-83ce-a0f45370ddcf 54868-4151 HUMAN PRESCRIPTION DRUG Femara letrozole TABLET, FILM COATED ORAL 20050210 NDA NDA020726 Physicians Total Care, Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 54868-4155_db05df82-8297-4bea-9036-dc5d651cac72 54868-4155 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20090122 ANDA ANDA065387 Physicians Total Care, Inc. AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-4159_c3768a3d-739f-4a72-a32f-3361beed0c8a 54868-4159 HUMAN PRESCRIPTION DRUG Celexa citalopram hydrobromide TABLET ORAL 20001128 NDA NDA020822 Physicians Total Care, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4164_58f5548b-ebc9-43e6-ba8b-525b335702db 54868-4164 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 20091007 NDA NDA020607 Physicians Total Care, Inc. DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 54868-4165_58f5548b-ebc9-43e6-ba8b-525b335702db 54868-4165 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 20041228 NDA NDA020607 Physicians Total Care, Inc. DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 54868-4170_db8dc821-7fde-48d3-a3aa-344a845037dd 54868-4170 HUMAN PRESCRIPTION DRUG Evista Raloxifene hydrochloride TABLET ORAL 20000511 NDA NDA020815 Physicians Total Care, Inc. RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 54868-4171_0ebcdcad-8eab-4d02-99fa-436b2ac366ca 54868-4171 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20010110 ANDA ANDA074761 Physicians Total Care, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 54868-4174_9adfdbd6-d4a4-4510-bbbb-dc615cfcd242 54868-4174 HUMAN PRESCRIPTION DRUG NASONEX mometasone furoate SPRAY, METERED NASAL 20000512 NDA NDA020762 Physicians Total Care, Inc. MOMETASONE FUROATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4175_3e9b0b41-65ab-47e1-8790-cccf368f68aa 54868-4175 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 20000512 NDA NDA020634 Physicians Total Care, Inc. LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-4176_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4176 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20010803 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-4177_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4177 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20000510 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-4184_e5f3b0c9-1c83-47b1-8de0-375ea9719d22 54868-4184 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20000515 NDA AUTHORIZED GENERIC NDA020401 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-4185_16db5abf-ec2b-49cd-8786-3adac0c005cb 54868-4185 HUMAN PRESCRIPTION DRUG Aciphex rabeprazole sodium TABLET, DELAYED RELEASE ORAL 20000515 NDA NDA020973 Physicians Total Care, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 54868-4186_e5f3b0c9-1c83-47b1-8de0-375ea9719d22 54868-4186 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20000515 NDA AUTHORIZED GENERIC NDA020401 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-4191_035934ee-0466-4e9f-b15d-1eba7aa748d2 54868-4191 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20001103 NDA NDA050775 Physicians Total Care, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-4195_bf43abc2-5b5e-4559-9908-2fc0c5a1d2c4 54868-4195 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride JELLY TOPICAL 20000601 ANDA ANDA040433 Physicians Total Care, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 54868-4198_1bbc11e0-ee07-4207-9cd9-6cba1a83be90 54868-4198 HUMAN PRESCRIPTION DRUG Avandia rosiglitazone maleate TABLET, FILM COATED ORAL 20060207 NDA NDA021071 Physicians Total Care, Inc. ROSIGLITAZONE MALEATE 4 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 54868-4199_bfe36888-1250-4d8c-b473-064cf7dfeb1d 54868-4199 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 20001121 NDA NDA020757 Physicians Total Care, Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-4211_898c5e2b-1c01-486f-a82e-0345fd3c5575 54868-4211 HUMAN PRESCRIPTION DRUG MIRAPEX pramipexole dihydrochloride TABLET ORAL 20070323 NDA NDA020667 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-4216_3caac0de-e24a-4abc-9dbb-42fd4445ceea 54868-4216 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20050422 ANDA ANDA075047 Physicians Total Care, Inc. ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-4221_1bbc11e0-ee07-4207-9cd9-6cba1a83be90 54868-4221 HUMAN PRESCRIPTION DRUG Avandia rosiglitazone maleate TABLET, FILM COATED ORAL 20010509 NDA NDA021071 Physicians Total Care, Inc. ROSIGLITAZONE MALEATE 8 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 54868-4224_ef0d7cf5-ed4e-47ea-8c4c-8426e03e7c82 54868-4224 HUMAN PRESCRIPTION DRUG LESCOL fluvastatin sodium CAPSULE ORAL 20020308 NDA NDA020261 Physicians Total Care, Inc. FLUVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-4226_c3768a3d-739f-4a72-a32f-3361beed0c8a 54868-4226 HUMAN PRESCRIPTION DRUG Celexa citalopram hydrobromide TABLET ORAL 20010905 NDA NDA020822 Physicians Total Care, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4229_2785c2fd-f22a-43aa-a781-e1218be9a70c 54868-4229 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20000706 NDA NDA020702 Physicians Total Care, Inc ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-4230_e7c2821a-12eb-4326-9b1c-ebe8f161cd3e 54868-4230 HUMAN PRESCRIPTION DRUG Prometrium progesterone CAPSULE ORAL 20041103 NDA NDA019781 Physicians Total Care, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 54868-4232_d6c7dd01-0f74-4b23-be7b-d419f298439d 54868-4232 HUMAN PRESCRIPTION DRUG Proctozone HC hydrocortisone CREAM TOPICAL 20071030 ANDA ANDA089682 Physicians Total Care, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4233_fec3456a-b279-4603-ab4d-6a5a7df8c0a2 54868-4233 HUMAN PRESCRIPTION DRUG NuLYTELY PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride POWDER, FOR SOLUTION ORAL 20010719 NDA NDA019797 Physicians Total Care, Inc. POLYETHYLENE GLYCOL 3350; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 210; 2.86; 5.6; .74 g/2L; g/2L; g/2L; g/2L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-4238_cf7ccdb1-796d-49b0-b840-79b467f5a2ed 54868-4238 HUMAN OTC DRUG Monistat 3 Combination Pack Miconazole Nitrate KIT 20120327 NDA NDA020670 Physicians Total Care, Inc. E 20171231 54868-4239_26c90873-6f0f-499b-a9cb-dec586bfd180 54868-4239 HUMAN PRESCRIPTION DRUG Trivora Levonogestrel and Ethinyl Estradiol KIT ORAL 20030512 ANDA ANDA074538 Physicians Total Care, Inc. E 20171231 54868-4240_5f47bfc7-b37f-4037-9130-9c7b22eba9eb 54868-4240 HUMAN PRESCRIPTION DRUG Zovia 1/35E-28 Ethynodiol Diacetate and Ethinyl Estradiol KIT ORAL 20030623 ANDA ANDA072721 Physicians Total Care, Inc. E 20171231 54868-4242_0743df29-7a29-4a45-85a4-3b2f6bdc91d8 54868-4242 HUMAN PRESCRIPTION DRUG Vivelle Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20030610 NDA NDA020538 Physicians Total Care, Inc. ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-4243_0743df29-7a29-4a45-85a4-3b2f6bdc91d8 54868-4243 HUMAN PRESCRIPTION DRUG Vivelle Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20030610 NDA NDA020538 Physicians Total Care, Inc. ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-4244_0743df29-7a29-4a45-85a4-3b2f6bdc91d8 54868-4244 HUMAN PRESCRIPTION DRUG Vivelle Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20030610 NDA NDA020538 Physicians Total Care, Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-4245_d76dc06e-e796-414c-87b3-0bf34fce34fc 54868-4245 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 20050509 NDA NDA020690 Physicians Total Care, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 54868-4247_7cf12d4f-b693-4e16-beaa-a6c0694c846a 54868-4247 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20000905 ANDA ANDA074823 Physicians Total Care, Inc. TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-4248_7cf12d4f-b693-4e16-beaa-a6c0694c846a 54868-4248 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20000829 ANDA ANDA074823 Physicians Total Care, Inc. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-4249_7cf12d4f-b693-4e16-beaa-a6c0694c846a 54868-4249 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20000829 ANDA ANDA074823 Physicians Total Care, Inc. TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-4250_e7c2821a-12eb-4326-9b1c-ebe8f161cd3e 54868-4250 HUMAN PRESCRIPTION DRUG Prometrium progesterone CAPSULE ORAL 20030314 NDA NDA019781 Physicians Total Care, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 54868-4251_d0733945-7cc7-409a-bdb3-b850cee648e2 54868-4251 HUMAN PRESCRIPTION DRUG MAXALT rizatriptan benzoate TABLET ORAL 20070824 NDA NDA020864 Physicians Total Care, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 54868-4252_4ef8ef93-8c46-4284-bd67-fa27db2f13de 54868-4252 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20010828 NDA NDA020699 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4253_4ef8ef93-8c46-4284-bd67-fa27db2f13de 54868-4253 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030425 NDA NDA020699 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4254_ab9d67ba-3e66-4664-a376-b65a4bfa7331 54868-4254 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20030930 NDA NDA020592 Physicians Total Care, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-4255_ab9d67ba-3e66-4664-a376-b65a4bfa7331 54868-4255 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20030820 NDA NDA020592 Physicians Total Care, Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-4257_a8e03fcb-e9fd-40e2-8516-febf36072b05 54868-4257 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20060428 NDA NDA020639 Physicians Total Care, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-4258_f8dca6ac-d788-471b-a766-249eb65adb6a 54868-4258 HUMAN PRESCRIPTION DRUG Allegra D-12 Hour fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20000918 NDA NDA020786 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 54868-4263_d35cb135-1059-4acd-8c5b-86f33f4a6200 54868-4263 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100308 ANDA ANDA078783 Physicians Total Care, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 54868-4271_60d25193-352b-425f-aa52-563f466a7604 54868-4271 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20010828 NDA NDA020987 Physicians Total Care, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 54868-4276_e3189b84-f38d-4e35-9c78-246d0fe55b85 54868-4276 HUMAN PRESCRIPTION DRUG ALPHAGAN P brimonidine tartrate SOLUTION/ DROPS OPHTHALMIC 20130308 NDA NDA021770 Physicians Total Care, Inc. BRIMONIDINE TARTRATE 1 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 54868-4277_2dac0cbe-637c-4cc3-86a4-9163182ac0d6 54868-4277 HUMAN PRESCRIPTION DRUG ALREX loteprednol etabonate SUSPENSION/ DROPS OPHTHALMIC 20021017 NDA NDA020803 Physicians Total Care, Inc. LOTEPREDNOL ETABONATE 2 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4278_5a11149e-7b63-44ca-b553-5cdf32c703c6 54868-4278 HUMAN PRESCRIPTION DRUG LOTEMAX loteprednol etabonate SUSPENSION/ DROPS OPHTHALMIC 20021017 NDA NDA020583 Physicians Total Care, Inc. LOTEPREDNOL ETABONATE 5 mg/mL E 20171231 54868-4279_ef504bb5-a027-48e7-8d06-1801370ffcdc 54868-4279 HUMAN PRESCRIPTION DRUG Cosopt dorzolamide hydrochloride and timolol maleate SOLUTION OPHTHALMIC 20021029 NDA NDA020869 Physicians Total Care, Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] E 20171231 54868-4286_c6d171e1-6765-4e8a-833e-7b071efd94ed 54868-4286 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20001009 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-4287_6630c8a2-8c01-4ae7-a48d-0bf6ffd5b22a 54868-4287 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20050117 ANDA ANDA074858 Physicians Total Care, Inc. TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 54868-4293_b9935760-abe9-489e-89b3-16a56a906944 54868-4293 HUMAN PRESCRIPTION DRUG Prednisolone Acetate Prednisolone Acetate SUSPENSION OPHTHALMIC 20021104 NDA AUTHORIZED GENERIC NDA017469 Physicians Total Care, Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4325_56fc8547-edb1-428b-9361-d43950d80b38 54868-4325 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin calcium OINTMENT TOPICAL 19960410 NDA NDA050703 Physicians Total Care, Inc. MUPIROCIN CALCIUM 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 54868-4331_41fa6817-f138-4843-bb0c-9f757ef2098a 54868-4331 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20020102 ANDA ANDA075483 Physicians Total Care, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-4332_41fa6817-f138-4843-bb0c-9f757ef2098a 54868-4332 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20020912 ANDA ANDA075483 Physicians Total Care, Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-4335_de862ac5-a1b5-485d-ac30-b691b7027e53 54868-4335 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 19970214 ANDA ANDA064120 Physicians Total Care, Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 54868-4336_f6285d9f-bf47-45e7-a767-39986c3f9e2a 54868-4336 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine SYRUP ORAL 20000913 ANDA ANDA087294 Physicians Total Care, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 54868-4338_24f5d411-51cf-4a93-9e6e-5b35b82e396e 54868-4338 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride SYRUP ORAL 20090731 ANDA ANDA040668 Physicians Total Care, Inc. CYPROHEPTADINE HYDROCHLORIDE 2 mg/5mL E 20171231 54868-4341_92a650f4-8eae-459c-91ad-2b7a9f2d2092 54868-4341 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20040409 NDA NDA020387 Physicians Total Care, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4342_f9091453-e7e9-4b6c-9f53-c5c0c4417261 54868-4342 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20000912 ANDA ANDA076925 Physicians Total Care, Inc. IBUPROFEN 100 mg/5mL E 20171231 54868-4343_bdf0fba9-2105-4e5e-b966-7cfa99a9206b 54868-4343 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 20071120 NDA NDA021073 Physicians Total Care, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 54868-4349_49c0d1e0-b392-4d27-a762-2f27405a5be3 54868-4349 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20001115 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-4350_97338446-4ae1-4e44-a353-171793776da0 54868-4350 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 20030919 ANDA ANDA075208 Physicians Total Care, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 54868-4352_39d05358-adcf-48a9-ad87-39e05d1fe577 54868-4352 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20061213 ANDA ANDA074700 Physicians Total Care, Inc. BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 54868-4354_bdf0fba9-2105-4e5e-b966-7cfa99a9206b 54868-4354 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 20050304 NDA NDA021073 Physicians Total Care, Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 54868-4356_36afb58e-02bb-48cd-888c-6346467b05d6 54868-4356 HUMAN PRESCRIPTION DRUG Flomax tamsulosin hydrochloride CAPSULE ORAL 20010828 NDA NDA020579 Physicians Total Care, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-4357_41fa6817-f138-4843-bb0c-9f757ef2098a 54868-4357 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20001129 ANDA ANDA075483 Physicians Total Care, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-4358_41fa6817-f138-4843-bb0c-9f757ef2098a 54868-4358 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20001129 ANDA ANDA075483 Physicians Total Care, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-4365_0c66fc6e-b13c-4efa-ac4e-82c4894ea0b8 54868-4365 HUMAN PRESCRIPTION DRUG Cipro ciprofloxacin hydrochloride, hydrocortisone and benzyl alcohol SUSPENSION AURICULAR (OTIC) 20090212 NDA NDA020805 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE; BENZYL ALCOHOL 2; 10; 9 mg/mL; mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Pediculicide [EPC] E 20171231 54868-4367_67c44e69-5ed9-45a7-b661-046bea803452 54868-4367 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20090716 NDA NDA021085 Physicians Total Care, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-4369_456d2bdf-4700-4f24-aa20-2e6e6c9ed1ff 54868-4369 HUMAN PRESCRIPTION DRUG MICRONOR norethindrone TABLET ORAL 20030917 NDA NDA016954 Physicians Total Care, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-4370_4bf65206-846b-4dbb-898e-44c9add76830 54868-4370 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20030609 ANDA ANDA040197 Physicians Total Care, Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-4377_94fe9007-c54b-4911-9363-9ca1c3e840dc 54868-4377 HUMAN PRESCRIPTION DRUG RELENZA zanamivir POWDER RESPIRATORY (INHALATION) 20090120 NDA NDA021036 Physicians Total Care, Inc. ZANAMIVIR 5 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] E 20171231 54868-4378_1e5cfbbe-db3d-4aa9-bb52-ab6e5afe299c 54868-4378 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20050616 ANDA ANDA017522 Physicians Total Care, Inc. TRETINOIN .05 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-4379_1e5cfbbe-db3d-4aa9-bb52-ab6e5afe299c 54868-4379 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20081017 ANDA ANDA017340 Physicians Total Care, Inc. TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-4381_d1df2bf7-621c-4b96-b2fb-1634fe9053e9 54868-4381 HUMAN PRESCRIPTION DRUG Humalog Mix75/25 Insulin lispro INJECTION, SUSPENSION SUBCUTANEOUS 20050222 NDA NDA021017 Physicians Total Care, Inc. INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 54868-4384_f7eed7fa-4c6f-4dfc-836d-4b8333aee0d3 54868-4384 HUMAN PRESCRIPTION DRUG Fosamax alendronate sodium TABLET ORAL 20001120 NDA NDA020560 Physicians Total Care, Inc. ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 54868-4386_b1023888-d89d-4c9f-9c22-c1722cdc204c 54868-4386 HUMAN PRESCRIPTION DRUG Actonel risedronate sodium TABLET, FILM COATED ORAL 20020315 NDA NDA020835 Physicians Total Care, Inc. RISEDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 54868-4388_4ed8e07c-0fb2-4bfe-86c3-8e4196d98ecb 54868-4388 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110913 ANDA ANDA075665 Physicians Total Care, Inc. ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-4391_bdf0fba9-2105-4e5e-b966-7cfa99a9206b 54868-4391 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET ORAL 20091022 NDA NDA021073 Physicians Total Care, Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 54868-4395_1a0963fd-d3b4-457f-89af-096afb7c5152 54868-4395 HUMAN PRESCRIPTION DRUG Coreg carvedilol TABLET, FILM COATED ORAL 20030620 NDA NDA020297 Physicians Total Care, Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 54868-4396_1a0963fd-d3b4-457f-89af-096afb7c5152 54868-4396 HUMAN PRESCRIPTION DRUG Coreg carvedilol TABLET, FILM COATED ORAL 20020523 NDA NDA020297 Physicians Total Care, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 54868-4399_f56d338e-e918-4ff5-acfa-ffd56c60c9b2 54868-4399 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride Ketamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAMUSCULAR; INTRAVENOUS 20020312 ANDA ANDA074549 Physicians Total Care, Inc. KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII E 20171231 54868-4400_49c0d1e0-b392-4d27-a762-2f27405a5be3 54868-4400 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20001114 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-4402_49c0d1e0-b392-4d27-a762-2f27405a5be3 54868-4402 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20001115 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-4409_e028add7-0ff7-409f-8e66-cb9e8986d403 54868-4409 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20001218 NDA NDA020837 Physicians Total Care, Inc. LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-4411_c724fadf-cfb7-48da-8f80-bebc6b224284 54868-4411 HUMAN PRESCRIPTION DRUG RHINOCORT AQUA Budesonide SPRAY, METERED NASAL 20010820 NDA NDA020746 Physicians Total Care, Inc. BUDESONIDE 32 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4413_0ea9f2ea-b3e0-4b3f-a89d-075b53044db4 54868-4413 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 20001121 NDA NDA020838 Physicians Total Care, Inc. CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-4414_bfe36888-1250-4d8c-b473-064cf7dfeb1d 54868-4414 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 20040510 NDA NDA020757 Physicians Total Care, Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-4416_86bbaf29-edef-432f-ba63-7ebd3f9d09bd 54868-4416 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20001127 ANDA ANDA075155 Physicians Total Care, Inc. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 54868-4417_86bbaf29-edef-432f-ba63-7ebd3f9d09bd 54868-4417 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20001127 ANDA ANDA075155 Physicians Total Care, Inc. ISOSORBIDE MONONITRATE 60 mg/1 E 20171231 54868-4419_23250621-f18c-486f-82a3-a9d8967e63de 54868-4419 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20001103 ANDA ANDA077942 Physicians Total Care, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 54868-4420_71c99c7c-76eb-425c-83d9-880c78c935a6 54868-4420 HUMAN PRESCRIPTION DRUG Glucotrol XL glipizide TABLET, EXTENDED RELEASE ORAL 20030508 NDA NDA020329 Physicians Total Care, Inc. GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-4421_1a0963fd-d3b4-457f-89af-096afb7c5152 54868-4421 HUMAN PRESCRIPTION DRUG Coreg carvedilol TABLET, FILM COATED ORAL 20001128 NDA NDA020297 Physicians Total Care, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 54868-4422_49c0d1e0-b392-4d27-a762-2f27405a5be3 54868-4422 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20001115 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-4424_1a0963fd-d3b4-457f-89af-096afb7c5152 54868-4424 HUMAN PRESCRIPTION DRUG Coreg carvedilol TABLET, FILM COATED ORAL 20001128 NDA NDA020297 Physicians Total Care, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 54868-4425_745ce298-abcb-4d11-8c0e-79776cdc6e2e 54868-4425 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20090622 NDA NDA020818 Physicians Total Care, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4428_745ce298-abcb-4d11-8c0e-79776cdc6e2e 54868-4428 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Physicians Total Care, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4431_3883e227-acaf-4daf-8319-6dc2fb5b6293 54868-4431 HUMAN PRESCRIPTION DRUG Sonata zaleplon CAPSULE ORAL 20040401 NDA NDA020859 Physicians Total Care, Inc. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 54868-4432_5651bc48-1227-4ca9-aaf9-805771c27090 54868-4432 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20001128 ANDA ANDA074587 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-4435_fc7059c3-f7ca-44e6-97d3-032fa8154037 54868-4435 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20001204 ANDA ANDA075366 Physicians Total Care, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] E 20171231 54868-4437_07f602ad-4afc-41c3-b5cb-0dfca799acf4 54868-4437 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100310 ANDA ANDA090377 Physicians Total Care, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-4438_70bc4da3-ae56-4157-abe8-d4f60b457e66 54868-4438 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20020523 ANDA ANDA075640 Physicians Total Care, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4442_0a0a3e7e-68d9-4201-bd3d-4fe0d7caf35b 54868-4442 HUMAN PRESCRIPTION DRUG AZELEX azelaic acid CREAM CUTANEOUS 20070531 NDA NDA020428 Physicians Total Care, Inc. AZELAIC ACID .2 g/g Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] E 20171231 54868-4444_1e5cfbbe-db3d-4aa9-bb52-ab6e5afe299c 54868-4444 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20090105 ANDA ANDA017579 Physicians Total Care, Inc. TRETINOIN .025 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-4448_cf0db9fc-dd0a-4976-a6a1-eeb3393e6511 54868-4448 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20010801 ANDA ANDA076294 Physicians Total Care, Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-4449_91407a94-b1c0-4ff9-a132-1c5168a2f4e2 54868-4449 HUMAN PRESCRIPTION DRUG NORITATE metronidazole CREAM TOPICAL 20050929 NDA NDA020743 Physicians Total Care, Inc. METRONIDAZOLE 10 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 54868-4451_7376e718-265d-4d1c-9eea-d044aaf034fe 54868-4451 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate CREAM TOPICAL 20020204 ANDA ANDA075042 Physicians Total Care, Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4453_72c76cf5-5886-4571-ad5b-3ab9869ddac2 54868-4453 HUMAN PRESCRIPTION DRUG Desonide Desonide OINTMENT TOPICAL 20060621 NDA NDA017426 Physicians Total Care, Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4456_96f093aa-a72d-4459-b737-f9ac09dd03ca 54868-4456 HUMAN PRESCRIPTION DRUG Tazorac Tazarotene GEL ORAL 20101021 NDA NDA020600 Physicians Total Care, Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-4462_f7eed7fa-4c6f-4dfc-836d-4b8333aee0d3 54868-4462 HUMAN PRESCRIPTION DRUG Fosamax alendronate sodium TABLET ORAL 20100217 NDA NDA020560 Physicians Total Care, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 54868-4463_f7eed7fa-4c6f-4dfc-836d-4b8333aee0d3 54868-4463 HUMAN PRESCRIPTION DRUG Fosamax alendronate sodium TABLET ORAL 20010205 NDA NDA020560 Physicians Total Care, Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 54868-4464_02ff92cb-2962-4bf9-9ad7-68971dd03345 54868-4464 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20010208 NDA NDA018803 Physicians Total Care, Inc. SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-4468_db05df82-8297-4bea-9036-dc5d651cac72 54868-4468 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060228 ANDA ANDA065378 Physicians Total Care, Inc. AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-4474_ab2d1f67-4b2a-4b51-ba4d-7a01b8577549 54868-4474 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride TABLET, FILM COATED ORAL 20020417 NDA NDA021176 Physicians Total Care, Inc. COLESEVELAM HYDROCHLORIDE 625 mg/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] E 20171231 54868-4476_88cfbec5-a553-46d5-bbfc-2c3a29b7f171 54868-4476 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 20021028 NDA NDA021087 Physicians Total Care, Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] E 20171231 54868-4477_91fda3d6-bdfe-4dcd-84ea-32817ce41a78 54868-4477 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20030911 ANDA ANDA040353 Physicians Total Care, Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 54868-4478_b141986d-5629-48d6-bf20-802ae2fc2dcb 54868-4478 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET ORAL 20120718 NDA AUTHORIZED GENERIC NDA020215 Physicians Total Care, Inc. ISOSORBIDE MONONITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 54868-4482_943adc58-3c44-4b5e-b7da-20d4b550a65b 54868-4482 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20010404 ANDA ANDA040597 Physicians Total Care, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 54868-4489_1c304460-91d1-4710-bcc9-8c9621b36a0b 54868-4489 HUMAN PRESCRIPTION DRUG Concerta Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20030321 NDA NDA021121 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-4492_219741f7-4f2b-4db1-aaca-4dc0482310df 54868-4492 HUMAN PRESCRIPTION DRUG PROVIGIL MODAFINIL TABLET ORAL 20050603 NDA NDA020717 Physicians Total Care, Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV E 20171231 54868-4494_4fe6e815-1d03-40df-ad3d-4d12de9648dc 54868-4494 HUMAN PRESCRIPTION DRUG Avalide irbesartan and hydrochlorothiazide TABLET ORAL 20010517 NDA NDA020758 Physicians Total Care, Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4497_2a0dd457-4727-47ff-9268-e9e1b9d17b30 54868-4497 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20040123 NDA NDA020475 Physicians Total Care, Inc. TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-4499_d0733945-7cc7-409a-bdb3-b850cee648e2 54868-4499 HUMAN PRESCRIPTION DRUG MAXALT-MLT rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20091229 NDA NDA020865 Physicians Total Care, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 54868-4502_03c5b3bd-62d0-4eec-8387-14ad97a93bba 54868-4502 HUMAN PRESCRIPTION DRUG Ditropan XL oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20030623 NDA NDA020897 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-4503_241104fd-a64f-4af3-b940-901cb4105875 54868-4503 HUMAN PRESCRIPTION DRUG CASODEX Bicalutamide TABLET ORAL 20020604 NDA NDA020498 Physicians Total Care, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] E 20171231 54868-4504_4ef8ef93-8c46-4284-bd67-fa27db2f13de 54868-4504 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20040407 NDA NDA020699 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4507_54642793-18db-4fca-9056-a2ca5a740e59 54868-4507 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20010416 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-4510_f7dd9177-838b-41a0-91e4-6e87100b7001 54868-4510 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20020502 NDA NDA021153 Physicians Total Care, Inc. ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-4512_7c89711c-07e8-404e-9946-bdaefdff3df1 54868-4512 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20020412 NDA NDA020823 Physicians Total Care, Inc. RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 54868-4514_3056bc9b-abd8-4f5a-bb6b-4acb629afac5 54868-4514 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20040903 NDA NDA021228 Physicians Total Care, Inc. TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-4515_fafcadd8-ff09-404c-b213-4edc15a22863 54868-4515 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, EXTENDED RELEASE ORAL 20030325 ANDA ANDA075028 Physicians Total Care, Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] E 20171231 54868-4516_f5991045-2524-422b-b5f4-af367fc2da81 54868-4516 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER ORAL; RESPIRATORY (INHALATION) 20010621 NDA NDA021077 Physicians Total Care, Inc. SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 500 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4517_f5991045-2524-422b-b5f4-af367fc2da81 54868-4517 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER ORAL; RESPIRATORY (INHALATION) 20010621 NDA NDA021077 Physicians Total Care, Inc. SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 250 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4518_f5991045-2524-422b-b5f4-af367fc2da81 54868-4518 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER ORAL; RESPIRATORY (INHALATION) 20010621 NDA NDA021077 Physicians Total Care, Inc. SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 100 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4525_373589f7-8b10-4196-a4ce-f80ea3f086c2 54868-4525 HUMAN PRESCRIPTION DRUG Elmiron pentosan polysulfate sodium CAPSULE, GELATIN COATED ORAL 20031217 NDA NDA020193 Physicians Total Care, Inc. PENTOSAN POLYSULFATE SODIUM 100 mg/1 Glycosaminoglycan [EPC],Glycosaminoglycans [Chemical/Ingredient] E 20171231 54868-4526_4fe6e815-1d03-40df-ad3d-4d12de9648dc 54868-4526 HUMAN PRESCRIPTION DRUG Avalide irbesartan and hydrochlorothiazide TABLET ORAL 20040908 NDA NDA020758 Physicians Total Care, Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4531_880eae0b-083d-495b-96d3-e268f7b62b07 54868-4531 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20090305 ANDA ANDA077899 Physicians Total Care, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 54868-4532_880eae0b-083d-495b-96d3-e268f7b62b07 54868-4532 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20070703 ANDA ANDA077899 Physicians Total Care, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 54868-4534_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4534 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20010803 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-4535_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4535 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20010822 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-4536_05cb0c12-5291-438e-93fd-86aa7cc81611 54868-4536 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20011211 NDA NDA021301 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-4537_6876c1b2-e3b1-474d-b8e1-5bf7e4b14d1d 54868-4537 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride CAPSULE ORAL 20081023 ANDA ANDA075207 Physicians Total Care, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4539_d6d6402a-3913-4adf-b6e6-f4676533a3a5 54868-4539 HUMAN PRESCRIPTION DRUG Micardis TELMISARTAN TABLET ORAL 20050119 NDA NDA020850 Physicians Total Care, Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-4540_e8331ace-719a-4405-97f1-fb137e7c2444 54868-4540 HUMAN PRESCRIPTION DRUG Micardis HCT TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET ORAL 20041216 NDA NDA021162 Physicians Total Care, Inc. TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4543_db05df82-8297-4bea-9036-dc5d651cac72 54868-4543 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20020312 ANDA ANDA065228 Physicians Total Care, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-4546_80b4b640-1b66-41c8-ac0b-9cb14780db7f 54868-4546 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20010831 ANDA ANDA075673 Physicians Total Care, Inc. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .64 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4548_77353d67-b531-4a49-b2c7-d70e42922a31 54868-4548 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20010904 ANDA ANDA075844 Physicians Total Care, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-4550_212beee0-c44a-465a-8113-7c1f004cb40d 54868-4550 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20040519 ANDA ANDA075491 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 54868-4556_14d729b6-586a-44cb-9589-ec032c0bc190 54868-4556 HUMAN PRESCRIPTION DRUG NABUMETONE Nabumetone TABLET, FILM COATED ORAL 20030915 ANDA ANDA078671 Physicians Total Care, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-4558_14d729b6-586a-44cb-9589-ec032c0bc190 54868-4558 HUMAN PRESCRIPTION DRUG NABUMETONE Nabumetone TABLET, FILM COATED ORAL 20021204 ANDA ANDA078671 Physicians Total Care, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-4560_0be54cea-ea5c-4c98-83c1-0d3ba1aa9d12 54868-4560 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine hydrochloride TABLET, FILM COATED ORAL 20030819 ANDA ANDA075755 Physicians Total Care, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4561_28e99e2c-3ec7-4dbd-9977-1d8e30689190 54868-4561 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET ORAL 20020312 ANDA ANDA075967 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-4562_6876c1b2-e3b1-474d-b8e1-5bf7e4b14d1d 54868-4562 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride fluoxetine CAPSULE ORAL 20080725 ANDA ANDA075207 Physicians Total Care, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4563_c1b540fa-05c6-4d49-ad9f-7a84c295771d 54868-4563 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20070710 ANDA ANDA075718 Physicians Total Care, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 54868-4564_28e99e2c-3ec7-4dbd-9977-1d8e30689190 54868-4564 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET ORAL 20020130 ANDA ANDA075967 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-4565_9bc8a9f9-3e12-46c0-a145-8a5f8cc09f88 54868-4565 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone TABLET ORAL 20041221 ANDA ANDA074253 Physicians Total Care, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 E 20171231 54868-4566_28e99e2c-3ec7-4dbd-9977-1d8e30689190 54868-4566 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET ORAL 20020311 ANDA ANDA075967 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-4567_c1b540fa-05c6-4d49-ad9f-7a84c295771d 54868-4567 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20021115 ANDA ANDA075718 Physicians Total Care, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 54868-4568_9bc8a9f9-3e12-46c0-a145-8a5f8cc09f88 54868-4568 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone TABLET ORAL 20090723 ANDA ANDA074253 Physicians Total Care, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 E 20171231 54868-4571_8ea73dd1-dfe3-4628-940f-16587e605fcb 54868-4571 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20011107 NDA NDA020616 Physicians Total Care, Inc. MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-4572_8ea73dd1-dfe3-4628-940f-16587e605fcb 54868-4572 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20011107 NDA NDA020616 Physicians Total Care, Inc. MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-4573_8ea73dd1-dfe3-4628-940f-16587e605fcb 54868-4573 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20081120 NDA NDA020616 Physicians Total Care, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-4575_79525f6c-c645-444a-acc1-93bc46edb8a1 54868-4575 HUMAN PRESCRIPTION DRUG LUMIGAN bimatoprost SOLUTION/ DROPS OPHTHALMIC 20010322 NDA NDA021275 Physicians Total Care, Inc. BIMATOPROST .3 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] E 20171231 54868-4576_c8c7e31c-5ea0-4a5b-8502-0bc7c7d4f065 54868-4576 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20020115 ANDA ANDA075579 Physicians Total Care, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4577_c8c7e31c-5ea0-4a5b-8502-0bc7c7d4f065 54868-4577 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20030612 ANDA ANDA075579 Physicians Total Care, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 2.5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4578_c8c7e31c-5ea0-4a5b-8502-0bc7c7d4f065 54868-4578 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20030801 ANDA ANDA075579 Physicians Total Care, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4582_1d82d084-abe7-4338-9f86-f607eb96ed12 54868-4582 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20100301 ANDA ANDA075765 Physicians Total Care, Inc. CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 54868-4584_1d82d084-abe7-4338-9f86-f607eb96ed12 54868-4584 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20051202 ANDA ANDA075765 Physicians Total Care, Inc. CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 54868-4585_98543b6f-554a-4697-af40-372f3da2219f 54868-4585 HUMAN PRESCRIPTION DRUG LOVASTATIN Lovastatin TABLET ORAL 20011221 ANDA ANDA078296 Physicians Total Care, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-4590_437e15f5-0f4b-4c76-ad83-9d2c3cfdac55 54868-4590 HUMAN PRESCRIPTION DRUG Yasmin drospirenone and ethinyl estradiol KIT 20020115 NDA NDA021098 Physicians Total Care, Inc. E 20171231 54868-4591_5c7fe409-289d-43d1-a9d4-1ee8eda9b07c 54868-4591 HUMAN PRESCRIPTION DRUG Verelan verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 20030612 NDA NDA019614 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-4593_98543b6f-554a-4697-af40-372f3da2219f 54868-4593 HUMAN PRESCRIPTION DRUG LOVASTATIN Lovastatin TABLET ORAL 20020128 ANDA ANDA078296 Physicians Total Care, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-4598_e387fd18-7c90-431b-8e9b-b381edb43c49 54868-4598 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, FILM COATED ORAL 20020206 ANDA ANDA076855 Physicians Total Care, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-4599_2192ea4b-7e98-4eb1-8415-570eeb6d2065 54868-4599 HUMAN PRESCRIPTION DRUG Ammonium Lactate Ammonium Lactate LOTION TOPICAL 20020214 ANDA ANDA075570 Physicians Total Care, Inc. AMMONIUM LACTATE 12 g/100g E 20171231 54868-4601_d1bfcf48-31d0-49a7-9b3e-e64d4bc11b87 54868-4601 HUMAN PRESCRIPTION DRUG LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE ORAL 20020312 NDA NDA021192 Physicians Total Care, Inc. FLUVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-4602_dba74198-1341-41e1-9f6e-a756104c434b 54868-4602 HUMAN PRESCRIPTION DRUG Levothroid LEVOTHYROXINE SODIUM TABLET ORAL 20020308 NDA NDA021116 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-4605_d6d6402a-3913-4adf-b6e6-f4676533a3a5 54868-4605 HUMAN PRESCRIPTION DRUG Micardis TELMISARTAN TABLET ORAL 20020325 NDA NDA020850 Physicians Total Care, Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-4607_832533a9-e6b5-4121-a23b-a8591c9c0bc7 54868-4607 HUMAN PRESCRIPTION DRUG Levora Levonorgestrel and Ethinyl Estradiol KIT ORAL 20020410 ANDA ANDA073594 Physicians Total Care, Inc. E 20171231 54868-4609_9dff28ce-aa5f-47ba-88e6-7435bdcc3bba 54868-4609 HUMAN PRESCRIPTION DRUG GLUCOVANCE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20020531 NDA NDA021178 Physicians Total Care, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-4617_e1f4e093-cf3f-4ce0-ba22-3fc5f3c4251c 54868-4617 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020419 ANDA ANDA075604 Physicians Total Care, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-4618_025855e1-a0be-4aeb-a346-bb36c3dfe872 54868-4618 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20020422 ANDA ANDA079029 Physicians Total Care, Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 54868-4624_eb68b814-4b53-4c44-95de-2cc71d442a9c 54868-4624 HUMAN PRESCRIPTION DRUG Clarinex desloratidine TABLET, FILM COATED ORAL 20020603 NDA NDA021297 Physicians Total Care, Inc. DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 54868-4626_929a6a1f-8668-425d-aec4-15793be80ea7 54868-4626 HUMAN PRESCRIPTION DRUG Lantus insulin glargin INJECTION, SOLUTION SUBCUTANEOUS 20020604 NDA NDA021081 Physicians Total Care, Inc. INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 54868-4630_ff09d876-3fc3-4826-b04b-f600a4cfba83 54868-4630 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 20020530 NDA NDA020830 Physicians Total Care, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 54868-4631_e1ec8388-3aeb-4259-8201-486191f06c84 54868-4631 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20020604 ANDA ANDA040440 Physicians Total Care, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-4635_f7dd9177-838b-41a0-91e4-6e87100b7001 54868-4635 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20020617 NDA NDA021153 Physicians Total Care, Inc. ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-4637_c92105c7-4189-49dd-b3c2-88f37b80b422 54868-4637 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090623 ANDA ANDA076007 Physicians Total Care, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4638_d4ab1662-3ee5-454c-ab23-22e679e5ab78 54868-4638 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20020621 ANDA ANDA076003 Physicians Total Care, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 54868-4640_bdecce86-e035-472d-8131-180414c321fe 54868-4640 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20050301 NDA NDA021303 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-4642_76d3c42c-12e8-4135-8ccf-3f3cb2d49de0 54868-4642 HUMAN PRESCRIPTION DRUG Bactroban mupirocin calcium CREAM TOPICAL 20020712 NDA NDA050746 Physicians Total Care, Inc. MUPIROCIN CALCIUM 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 54868-4645_7c4c1776-6fe6-419a-9eb6-3e365693efa3 54868-4645 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20080228 NDA NDA021283 Physicians Total Care, Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-4646_993c5da6-8c27-4df7-a136-c2814e50ba60 54868-4646 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20040825 ANDA ANDA075994 Physicians Total Care, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-4647_9bc8a9f9-3e12-46c0-a145-8a5f8cc09f88 54868-4647 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone TABLET ORAL 20070917 ANDA ANDA074253 Physicians Total Care, Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 E 20171231 54868-4651_ff21fddf-da6b-49cb-b27f-20e8fde8e6db 54868-4651 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin sodium INJECTION INTRAMUSCULAR 20030915 ANDA ANDA065047 Physicians Total Care, Inc. CEFAZOLIN SODIUM 500 mg/10mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-4652_7c4c1776-6fe6-419a-9eb6-3e365693efa3 54868-4652 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20100106 NDA NDA021283 Physicians Total Care, Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-4654_4c539f04-059e-485a-8a8e-038ccb474b2b 54868-4654 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate GEL TOPICAL 20050407 ANDA ANDA064160 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 54868-4656_993c5da6-8c27-4df7-a136-c2814e50ba60 54868-4656 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20090216 ANDA ANDA075994 Physicians Total Care, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-4657_993c5da6-8c27-4df7-a136-c2814e50ba60 54868-4657 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20050725 ANDA ANDA075994 Physicians Total Care, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-4658_993c5da6-8c27-4df7-a136-c2814e50ba60 54868-4658 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20070917 ANDA ANDA075994 Physicians Total Care, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-4663_0d231e91-00f1-482d-aa82-01031de593af 54868-4663 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20090916 ANDA ANDA074046 Physicians Total Care, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-4665_e899df9b-095c-4c16-895f-3307f9810383 54868-4665 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031203 NDA NDA021368 Physicians Total Care, Inc. TADALAFIL 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 54868-4668_0e9a5a51-266a-490c-90fd-f553a5d378de 54868-4668 HUMAN PRESCRIPTION DRUG SUSTIVA efavirenz TABLET, FILM COATED ORAL 20121011 NDA NDA021360 Physicians Total Care, Inc. EFAVIRENZ 600 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] E 20171231 54868-4671_b1023888-d89d-4c9f-9c22-c1722cdc204c 54868-4671 HUMAN PRESCRIPTION DRUG Actonel risedronate sodium TABLET, FILM COATED ORAL 20020916 NDA NDA020835 Physicians Total Care, Inc. RISEDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 54868-4672_1464cdb0-3223-4e7b-81fb-c9f1b4a57f0f 54868-4672 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 20040108 NDA NDA020505 Physicians Total Care, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-4673_430621f8-c3cb-44a1-88f4-b13adbba4bfd 54868-4673 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 20110216 NDA NDA020241 Physicians Total Care, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 54868-4674_1464cdb0-3223-4e7b-81fb-c9f1b4a57f0f 54868-4674 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 20030723 NDA NDA020505 Physicians Total Care, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-4675_430621f8-c3cb-44a1-88f4-b13adbba4bfd 54868-4675 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 20080509 NDA NDA020241 Physicians Total Care, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 54868-4677_d59bd7ca-4da9-4f02-942a-d99066b741eb 54868-4677 HUMAN PRESCRIPTION DRUG Estradiol / Norethindrone Acetate Estradiol and Norethindrone Acetate TABLET, FILM COATED ORAL 20100310 ANDA ANDA078324 Physicians Total Care, Inc. ESTRADIOL; NORETHINDRONE ACETATE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-4678_993c5da6-8c27-4df7-a136-c2814e50ba60 54868-4678 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20080410 ANDA ANDA075994 Physicians Total Care, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-4679_50ce7901-3328-49fe-a773-ed3ca33e6320 54868-4679 HUMAN PRESCRIPTION DRUG femhrt norethindrone acetate/ethinyl estradiol TABLET ORAL 20020924 NDA NDA021065 Physicians Total Care, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; 5 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-4683_03e2ff00-c8ab-43dc-94af-4705dde13a8c 54868-4683 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20080420 ANDA ANDA065390 Physicians Total Care, Inc. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 54868-4687_f1bacd71-d3dc-44ac-aa69-ea49bbf77be5 54868-4687 HUMAN PRESCRIPTION DRUG Demadex Torsemide TABLET ORAL 20091021 NDA NDA020136 Physicians Total Care, Inc. TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 54868-4690_e3189b84-f38d-4e35-9c78-246d0fe55b85 54868-4690 HUMAN PRESCRIPTION DRUG ALPHAGAN P brimonidine tartrate SOLUTION/ DROPS OPHTHALMIC 20021016 NDA NDA021262 Physicians Total Care, Inc. BRIMONIDINE TARTRATE 1.5 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 54868-4691_0b4809cb-28f6-463c-87a9-31ef3cccc4ed 54868-4691 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 20021016 NDA NDA020330 Physicians Total Care, Inc. TIMOLOL MALEATE 6.8 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-4697_b7a5e37c-1554-4ba6-8950-19e2bfddba69 54868-4697 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20130110 ANDA ANDA040075 Physicians Total Care, Inc. CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL E 20171231 54868-4698_a8c8707d-f588-4cd9-b5d6-93aca8fda7c4 54868-4698 HUMAN OTC DRUG Sodium Chloride Sodium Chloride OINTMENT OPHTHALMIC 20060330 OTC MONOGRAPH FINAL part349 Physicians Total Care, Inc. SODIUM CHLORIDE 50 mg/g E 20171231 54868-4700_2c717d2f-6a42-44cd-815f-3efe43cce3c8 54868-4700 HUMAN PRESCRIPTION DRUG Lexapro escitalopram oxalate TABLET ORAL 20051228 NDA NDA021323 Physicians Total Care, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4703_03e281c5-b5df-437d-a6d1-150c1be83262 54868-4703 HUMAN PRESCRIPTION DRUG ULTRACET tramadol hydrochloride and acetaminophen TABLET, COATED ORAL 20021030 NDA NDA021123 Physicians Total Care, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 54868-4705_b5a4afc1-5622-4146-b1af-66f54f922425 54868-4705 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20070913 NDA NDA021518 Physicians Total Care, Inc. SOLIFENACIN SUCCINATE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-4706_40d47894-7517-49bd-a937-80b5b5217b0d 54868-4706 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Physicians Total Care, Inc. SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 54868-4711_6d47c815-1af7-4a96-9daf-e1a63050cea4 54868-4711 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20021202 ANDA ANDA090624 Physicians Total Care, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 54868-4714_1e319b95-24f3-4b75-8d58-b96ef68d8651 54868-4714 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 Physicians Total Care, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-4718_79201e83-d9e6-42a7-98b6-bd51edbdc233 54868-4718 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20021223 NDA NDA021259 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-4719_d63c02ef-a2c3-4dd1-b61e-6cd29b5ef341 54868-4719 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20021226 NDA NDA021445 Physicians Total Care, Inc. EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] E 20171231 54868-4721_a5ed6899-9939-456c-9735-a418b7ce6357 54868-4721 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20030210 ANDA ANDA040101 Physicians Total Care, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-4725_ec557674-815f-4ad7-8922-f1d38a499ea5 54868-4725 HUMAN PRESCRIPTION DRUG Dovonex calcipotriene CREAM TOPICAL 20060915 NDA NDA020554 Physicians Total Care, Inc. CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] E 20171231 54868-4728_e1ec8388-3aeb-4259-8201-486191f06c84 54868-4728 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20030117 ANDA ANDA040440 Physicians Total Care, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-4729_714d8082-a99d-4580-9ff6-2c569bbbda65 54868-4729 HUMAN PRESCRIPTION DRUG ATACAND HCT Candesartan cilexetil and Hydrochlorothiazide TABLET ORAL 20030121 NDA NDA021093 Physicians Total Care, Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4730_27230615-7bf4-4bbd-b548-1acfe18c1635 54868-4730 HUMAN PRESCRIPTION DRUG ORTHO TRI CYCLEN Lo norgestimate and ethinyl estradiol KIT 20030123 NDA NDA021241 Physicians Total Care, Inc. E 20171231 54868-4733_8d2e23e7-c5fb-47f6-99b0-7a7fdf823da5 54868-4733 HUMAN PRESCRIPTION DRUG Skelaxin Metaxalone TABLET ORAL 20030130 NDA NDA013217 Physicians Total Care, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 54868-4735_dfaf9a26-c4ea-4a66-9723-c55ad6d6dffb 54868-4735 HUMAN PRESCRIPTION DRUG AugmentinXR amoxicillin and clavulanate potassium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030130 NDA NDA050785 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 1000; 62.5 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 54868-4742_d6110a6b-a8dd-4090-ac83-fda8fcfebd9e 54868-4742 HUMAN PRESCRIPTION DRUG KARIVA desogestrel/ethinyl estradiol and ethinyl estradiol KIT 20030218 ANDA ANDA075863 Physicians Total Care, Inc. E 20171231 54868-4743_96632530-85c4-4b9f-a751-42981e9a0d4c 54868-4743 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20030221 ANDA ANDA065064 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 54868-4744_2da371ca-e885-413a-849b-cc6a10ac6219 54868-4744 HUMAN PRESCRIPTION DRUG Microgestin Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20030224 ANDA ANDA075647 Physicians Total Care, Inc. E 20171231 54868-4747_284c446e-aa73-4f3d-87b3-b4c28c56c08e 54868-4747 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 20030327 ANDA ANDA040182 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 167 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 54868-4748_6c8f1031-01ab-43e8-b0f7-ec96b66e618b 54868-4748 HUMAN PRESCRIPTION DRUG Prednisolone prednisolone SYRUP ORAL 20030228 ANDA ANDA040423 Physicians Total Care, Inc. PREDNISOLONE 5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4749_6c8f1031-01ab-43e8-b0f7-ec96b66e618b 54868-4749 HUMAN PRESCRIPTION DRUG Prednisolone prednisolone SYRUP ORAL 20030228 ANDA ANDA040323 Physicians Total Care, Inc. PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4750_9bc7d9be-cbb2-42f7-a965-482a7c9fc184 54868-4750 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20030305 NDA NDA021282 Physicians Total Care, Inc. GUAIFENESIN 600 mg/1 E 20171231 54868-4751_2ed9b59c-40be-4140-aa8e-1584dcd09329 54868-4751 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20030311 NDA NDA021171 Physicians Total Care, Inc. MEPERIDINE HYDROCHLORIDE 100 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-4754_93099c25-5a99-4140-8837-120ab66570b4 54868-4754 HUMAN PRESCRIPTION DRUG APRI Desogestrel and Ethinyl Estradiol KIT 20030310 ANDA ANDA075256 Physicians Total Care, Inc. E 20171231 54868-4759_1c304460-91d1-4710-bcc9-8c9621b36a0b 54868-4759 HUMAN PRESCRIPTION DRUG Concerta Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20030320 NDA NDA021121 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-4760_bdecce86-e035-472d-8131-180414c321fe 54868-4760 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20030320 NDA NDA021303 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-4761_210798f9-c1d1-4c6b-bfe9-06c02c801234 54868-4761 HUMAN PRESCRIPTION DRUG Estropipate estropipate TABLET ORAL 20030326 ANDA ANDA081215 Physicians Total Care, Inc. ESTROPIPATE 3 mg/1 E 20171231 54868-4767_d31c8c05-2dc2-44bc-9702-2ff81ef2ed88 54868-4767 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20030403 ANDA ANDA075509 Physicians Total Care, Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-4768_41cac0ee-a39b-4f65-b3b2-fb48d7dbf777 54868-4768 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate SF guaifenesin and codeine phosphate LIQUID ORAL 20110426 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV E 20171231 54868-4770_c92c4adf-6ff2-4eda-a868-b0af18b08ae6 54868-4770 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride TABLET, FILM COATED ORAL 20050518 ANDA ANDA075998 Physicians Total Care, Inc. PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] E 20171231 54868-4773_5d76dd07-6818-4ef2-9fa5-36c3d367f6dd 54868-4773 HUMAN PRESCRIPTION DRUG HYDROXYUREA Hydroxyurea CAPSULE ORAL 20030411 ANDA ANDA075143 Physicians Total Care, Inc. HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] E 20171231 54868-4774_98543b6f-554a-4697-af40-372f3da2219f 54868-4774 HUMAN PRESCRIPTION DRUG LOVASTATIN Lovastatin TABLET ORAL 20030414 ANDA ANDA078296 Physicians Total Care, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-4775_2c717d2f-6a42-44cd-815f-3efe43cce3c8 54868-4775 HUMAN PRESCRIPTION DRUG Lexapro escitalopram oxalate TABLET ORAL 20090415 NDA NDA021323 Physicians Total Care, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4778_5f47bfc7-b37f-4037-9130-9c7b22eba9eb 54868-4778 HUMAN PRESCRIPTION DRUG Zovia 1/50E-28 Ethynodiol Diacetate and Ethinyl Estradiol KIT ORAL 20030421 ANDA ANDA072723 Physicians Total Care, Inc. E 20171231 54868-4779_09893986-19e0-4364-93ba-5fbc7e7d3eed 54868-4779 HUMAN PRESCRIPTION DRUG UROCIT-K potassium citrate TABLET, EXTENDED RELEASE ORAL 20030417 NDA NDA019071 Physicians Total Care, Inc. POTASSIUM CITRATE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-4780_993c5da6-8c27-4df7-a136-c2814e50ba60 54868-4780 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20070412 ANDA ANDA075994 Physicians Total Care, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-4784_40d47894-7517-49bd-a937-80b5b5217b0d 54868-4784 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Physicians Total Care, Inc. SILDENAFIL CITRATE 25 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 54868-4785_c92105c7-4189-49dd-b3c2-88f37b80b422 54868-4785 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20070918 ANDA ANDA076007 Physicians Total Care, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4786_60d25193-352b-425f-aa52-563f466a7604 54868-4786 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20030502 NDA NDA020987 Physicians Total Care, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 54868-4789_1c304460-91d1-4710-bcc9-8c9621b36a0b 54868-4789 HUMAN PRESCRIPTION DRUG Concerta Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20030508 NDA NDA021121 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-4791_52f498a2-11b0-46be-bb67-14054aa3c2c5 54868-4791 HUMAN PRESCRIPTION DRUG PAXILCR CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030516 NDA NDA020936 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4792_e1db502f-fa92-4a34-9c93-68bdfb38ba85 54868-4792 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20030515 NDA NDA021015 Physicians Total Care, Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 54868-4793_10aaf531-4033-442c-821d-69292ccf5f85 54868-4793 HUMAN PRESCRIPTION DRUG RESTASIS cyclosporine EMULSION OPHTHALMIC 20090327 NDA NDA050790 Physicians Total Care, Inc. CYCLOSPORINE .5 mg/mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-4794_0da34cd6-c336-4f3c-b29f-06a1eaae90ac 54868-4794 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20030520 ANDA ANDA040603 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-4798_b0271054-5ec6-4bd4-9dfb-7bd4092ad668 54868-4798 HUMAN PRESCRIPTION DRUG VIGAMOX moxifloxacin hydrochloride SOLUTION OPHTHALMIC 20030522 NDA NDA021598 Physicians Total Care, Inc. MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-4799_ad2bc73b-0000-44fa-aacb-22432871e093 54868-4799 HUMAN PRESCRIPTION DRUG Flunisolide Flunisolide SOLUTION NASAL 20030523 ANDA ANDA074805 Physicians Total Care, Inc. FLUNISOLIDE .25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4801_d31c8c05-2dc2-44bc-9702-2ff81ef2ed88 54868-4801 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20030528 ANDA ANDA075509 Physicians Total Care, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-4802_d31c8c05-2dc2-44bc-9702-2ff81ef2ed88 54868-4802 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20030528 ANDA ANDA075509 Physicians Total Care, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-4803_7cf12d4f-b693-4e16-beaa-a6c0694c846a 54868-4803 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20030602 ANDA ANDA074823 Physicians Total Care, Inc. TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-4805_ca776d20-c4c3-485a-9c31-c6eb017cc8a9 54868-4805 HUMAN PRESCRIPTION DRUG CLINDAMYCIN PHOSPHATE clindamycin phosphate SOLUTION TOPICAL 20030604 ANDA ANDA065049 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 54868-4806_4c539f04-059e-485a-8a8e-038ccb474b2b 54868-4806 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate LOTION TOPICAL 20030603 ANDA ANDA065067 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 54868-4810_e1db502f-fa92-4a34-9c93-68bdfb38ba85 54868-4810 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20030605 NDA NDA021015 Physicians Total Care, Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 54868-4811_6b062f20-7f3a-4161-b245-309ff37ef20f 54868-4811 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20030614 ANDA ANDA075182 Physicians Total Care, Inc. ESTRADIOL .97 mg/48[USP'U] Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-4812_154afefc-0884-4dd2-98f4-a7f8f4d7e203 54868-4812 HUMAN PRESCRIPTION DRUG Cholestyramine cholestyramine POWDER, FOR SUSPENSION ORAL 20100322 ANDA ANDA077204 Physicians Total Care, Inc. CHOLESTYRAMINE 4 g/9g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] E 20171231 54868-4813_6b062f20-7f3a-4161-b245-309ff37ef20f 54868-4813 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20030609 ANDA ANDA075182 Physicians Total Care, Inc. ESTRADIOL 1.46 mg/48[USP'U] Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-4814_91815679-bdd9-4cf3-bd35-2593f7db8d90 54868-4814 HUMAN PRESCRIPTION DRUG Camila Norethindrone TABLET ORAL 20030619 ANDA ANDA076177 Physicians Total Care, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-4817_325a1e76-23a1-47e2-961c-e1c21e9a0ea7 54868-4817 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20090218 ANDA ANDA075356 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4819_0f1ad27b-69a7-49e2-bab8-c520474fec26 54868-4819 HUMAN PRESCRIPTION DRUG EpiPen Jr epinephrine INJECTION INTRAMUSCULAR 20030617 NDA NDA019430 Physicians Total Care, Inc. EPINEPHRINE .15 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 54868-4826_b77c9d7d-6c4c-4716-b724-72e15b3ea4d2 54868-4826 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE, EXTENDED RELEASE ORAL 20090623 ANDA ANDA075679 Physicians Total Care, Inc. KETOPROFEN 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-4832_f242e87a-ac72-4467-a010-7ba3c74a9987 54868-4832 HUMAN PRESCRIPTION DRUG NuvaRing etonogestrel and ethinyl estradiol INSERT, EXTENDED RELEASE VAGINAL 20111104 NDA NDA021187 Physicians Total Care, Inc. ETONOGESTREL; ETHINYL ESTRADIOL 11.7; 2.7 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-4835_03c5b3bd-62d0-4eec-8387-14ad97a93bba 54868-4835 HUMAN PRESCRIPTION DRUG Ditropan XL oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20030625 NDA NDA020897 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-4836_b1c1aaba-8e43-4381-95f1-2c303f88b7e5 54868-4836 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine TABLET, FILM COATED ORAL 20030707 NDA NDA021014 Physicians Total Care, Inc. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-4837_b1c1aaba-8e43-4381-95f1-2c303f88b7e5 54868-4837 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine TABLET, FILM COATED ORAL 20030702 NDA NDA021014 Physicians Total Care, Inc. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-4842_eb12bd6a-9815-4687-8ac7-0bb533fe0137 54868-4842 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20030702 ANDA ANDA074686 Physicians Total Care, Inc. GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-4844_5f16b396-90a5-4159-bd8e-71f7f7128f34 54868-4844 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20030819 ANDA ANDA074787 Physicians Total Care, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-4847_ff09d876-3fc3-4826-b04b-f600a4cfba83 54868-4847 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 20030703 NDA NDA020830 Physicians Total Care, Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 54868-4848_ba964216-8607-4574-8465-589a4ba3bdde 54868-4848 HUMAN PRESCRIPTION DRUG REMERON MIRTAZAPINE TABLET, FILM COATED ORAL 20010320 NDA NDA020415 Physicians Total Care, Inc. MIRTAZAPINE 15 mg/1 E 20171231 54868-4850_8d9ced0e-fe9a-4619-b280-744d81cdad2e 54868-4850 HUMAN PRESCRIPTION DRUG Low-Ogestrel Norgestrel and Ethinyl Estradiol KIT ORAL 20090924 ANDA ANDA075288 Physicians Total Care, Inc. E 20171231 54868-4851_5b606e76-bc7b-491a-93d4-36acf0d437ae 54868-4851 HUMAN PRESCRIPTION DRUG CRYSELLE norgestrel and ethinyl estradiol KIT 20031016 ANDA ANDA075840 Physicians Total Care, Inc. E 20171231 54868-4853_9be8d609-5c17-498f-9a25-c2faed75a09b 54868-4853 HUMAN PRESCRIPTION DRUG Emtriva emtricitabine CAPSULE ORAL 20030710 NDA NDA021500 Physicians Total Care, Inc. EMTRICITABINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 54868-4857_e59e8cfa-c250-483e-b545-d37e1b4baf8b 54868-4857 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR SULFATE CAPSULE, GELATIN COATED ORAL 20030716 NDA NDA021567 Physicians Total Care, Inc. ATAZANAVIR SULFATE 150 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 54868-4858_e893a339-a5f4-4d9b-8854-4d972cbc8590 54868-4858 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20030912 ANDA ANDA076794 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-4860_cc362b61-1ff0-4daf-80ee-69868519d256 54868-4860 HUMAN PRESCRIPTION DRUG ENPRESSE levonorgestrel and ethinyl estradiol KIT 20030722 ANDA ANDA075809 Physicians Total Care, Inc. E 20171231 54868-4863_e1ec8388-3aeb-4259-8201-486191f06c84 54868-4863 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20030725 ANDA ANDA040440 Physicians Total Care, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-4864_790831a1-b88b-4279-b34c-4d76dd20a266 54868-4864 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 20071101 OTC MONOGRAPH NOT FINAL part343 Physicians Total Care, Inc. ASPIRIN 81 mg/1 E 20171231 54868-4866_28327f6d-9226-4266-bfb2-7a89715a978b 54868-4866 HUMAN PRESCRIPTION DRUG Prempro conjugated estrogens and medroxyprogesterone acetate TABLET, SUGAR COATED ORAL 20030725 NDA NDA020527 Physicians Total Care, Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .45; 1.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-4867_5f3d6306-fa1b-4280-9b1f-fd6f9cedc97c 54868-4867 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050329 NDA NDA020381 Physicians Total Care, Inc. NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 54868-4868_02240487-411f-4d1c-94b4-ce9958df78f3 54868-4868 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem CAPSULE, EXTENDED RELEASE ORAL 20040524 ANDA ANDA074984 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-4869_714d8082-a99d-4580-9ff6-2c569bbbda65 54868-4869 HUMAN PRESCRIPTION DRUG ATACAND HCT Candesartan cilexetil and Hydrochlorothiazide TABLET ORAL 20031113 NDA NDA021093 Physicians Total Care, Inc. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4870_8a1277c4-9a11-4cc9-8a6b-aea181d8c75c 54868-4870 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20030730 NDA NDA020364 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-4871_49c0d1e0-b392-4d27-a762-2f27405a5be3 54868-4871 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20030806 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-4873_c6d171e1-6765-4e8a-833e-7b071efd94ed 54868-4873 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20030806 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-4875_62a34e85-f86f-407b-9809-8b33c073b33c 54868-4875 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030811 NDA AUTHORIZED GENERIC NDA019684 Physicians Total Care, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 54868-4876_1680e527-98c3-4972-ac07-86a70a83fc18 54868-4876 HUMAN PRESCRIPTION DRUG Guanfacine guanfacine hydrochloride TABLET ORAL 20030731 ANDA ANDA074796 Physicians Total Care, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54868-4878_c21cfbda-8878-4586-b356-77ba949bd877 54868-4878 HUMAN PRESCRIPTION DRUG Elidel pimecrolimus CREAM TOPICAL 20031030 NDA NDA021302 Physicians Total Care, Inc. PIMECROLIMUS 10 mg/g Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] E 20171231 54868-4879_f0646bea-d356-441c-8b53-a89245a3762c 54868-4879 HUMAN PRESCRIPTION DRUG Cenestin synthetic conjugated estrogens, A TABLET, FILM COATED ORAL 20030811 NDA NDA020992 Physicians Total Care, Inc. ESTROGENS, CONJUGATED SYNTHETIC A .625 mg/1 E 20171231 54868-4883_d3ca750e-3050-4214-aea8-cffa33a2d61a 54868-4883 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET ORAL 20040427 ANDA ANDA078454 Physicians Total Care, Inc. MOEXIPRIL HYDROCHLORIDE 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-4885_16a9da03-d763-4c90-a175-7739c59b0d16 54868-4885 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20030806 NDA NDA021286 Physicians Total Care, Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-4892_e4fe38fa-19f0-4476-9723-e51767dfeb78 54868-4892 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040322 ANDA ANDA075932 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 54868-4894_541e86b5-ee7a-4f93-b67b-50611e8c4798 54868-4894 HUMAN PRESCRIPTION DRUG Plan B Levonorgestrel TABLET ORAL 20030814 NDA NDA021045 Physicians Total Care, Inc. LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] E 20171231 54868-4895_d31c8c05-2dc2-44bc-9702-2ff81ef2ed88 54868-4895 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20030814 ANDA ANDA075509 Physicians Total Care, Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-4897_219741f7-4f2b-4db1-aaca-4dc0482310df 54868-4897 HUMAN PRESCRIPTION DRUG PROVIGIL MODAFINIL TABLET ORAL 20040119 NDA NDA020717 Physicians Total Care, Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV E 20171231 54868-4898_e893a339-a5f4-4d9b-8854-4d972cbc8590 54868-4898 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20030819 ANDA ANDA076794 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-4899_5f3d6306-fa1b-4280-9b1f-fd6f9cedc97c 54868-4899 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090727 NDA NDA020381 Physicians Total Care, Inc. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 54868-4903_5f16b396-90a5-4159-bd8e-71f7f7128f34 54868-4903 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20040825 ANDA ANDA074787 Physicians Total Care, Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-4904_78f83075-c908-4385-8690-9ff0a573ff17 54868-4904 HUMAN PRESCRIPTION DRUG Lotensin HCT benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20030829 NDA NDA020033 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4907_9785289c-e261-4b55-97bd-2e0e506c5525 54868-4907 HUMAN PRESCRIPTION DRUG Halobetasol Propionate halobetasol propionate CREAM TOPICAL 20050525 ANDA ANDA077123 Physicians Total Care, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4909_30425296-6515-4eca-9207-6886806a389c 54868-4909 HUMAN PRESCRIPTION DRUG PREVPAC lansoprazole, amoxicillin and clarithromycin KIT 20050520 NDA NDA050757 Physicians Total Care, Inc. E 20171231 54868-4910_ab9a95a4-6432-490d-b93e-38cfdd45fc6a 54868-4910 HUMAN PRESCRIPTION DRUG ENTOCORT EC Budesonide CAPSULE ORAL 20060522 NDA NDA021324 Physicians Total Care, Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4912_898c5e2b-1c01-486f-a82e-0345fd3c5575 54868-4912 HUMAN PRESCRIPTION DRUG MIRAPEX pramipexole dihydrochloride TABLET ORAL 20030904 NDA NDA020667 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-4916_430621f8-c3cb-44a1-88f4-b13adbba4bfd 54868-4916 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 20070527 NDA NDA020241 Physicians Total Care, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 54868-4917_55569cb4-d14c-46a3-a7b4-549e5e9e1d4f 54868-4917 HUMAN OTC DRUG Senna/Docusate Sodium Docusate sodium and Sennosides TABLET, FILM COATED ORAL 20030911 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 E 20171231 54868-4918_dba74198-1341-41e1-9f6e-a756104c434b 54868-4918 HUMAN PRESCRIPTION DRUG Levothroid LEVOTHYROXINE SODIUM TABLET ORAL 20030912 NDA NDA021116 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-4920_0743df29-7a29-4a45-85a4-3b2f6bdc91d8 54868-4920 HUMAN PRESCRIPTION DRUG Vivelle Dot estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20030923 NDA NDA020538 Physicians Total Care, Inc. ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-4921_5f16b396-90a5-4159-bd8e-71f7f7128f34 54868-4921 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20040506 ANDA ANDA074787 Physicians Total Care, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-4928_45f86d7d-70c1-4f0f-b624-52973dcb4da6 54868-4928 HUMAN PRESCRIPTION DRUG Ciprodex ciprofloxacin and dexamethasone SUSPENSION AURICULAR (OTIC) 20040921 NDA NDA021537 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE 3; 1 mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-4932_2effcdad-6bba-4e82-a3d2-9cacf46ecd1c 54868-4932 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20031007 ANDA ANDA075541 Physicians Total Care, Inc. BETAXOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-4934_2785c2fd-f22a-43aa-a781-e1218be9a70c 54868-4934 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20060111 NDA NDA020702 Physicians Total Care, Inc ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-4935_97320ca9-fbbf-4536-a667-24e225e609fb 54868-4935 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20031008 NDA NDA021515 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 54868-4937_325a1e76-23a1-47e2-961c-e1c21e9a0ea7 54868-4937 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20081015 ANDA ANDA075356 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4938_325a1e76-23a1-47e2-961c-e1c21e9a0ea7 54868-4938 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20040407 ANDA ANDA075356 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4939_fe0547b0-9f3b-4c64-901a-66999401e26d 54868-4939 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20040119 ANDA ANDA076286 Physicians Total Care, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54868-4947_447e39ea-78d1-47f1-80f0-a95bdc4ed962 54868-4947 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20031030 NDA NDA021035 Physicians Total Care, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-4948_e471506d-cd02-4fcc-acbd-bb881d13561a 54868-4948 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20040107 ANDA ANDA040517 Physicians Total Care, Inc. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-4950_c6d171e1-6765-4e8a-833e-7b071efd94ed 54868-4950 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20031021 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-4951_96632530-85c4-4b9f-a751-42981e9a0d4c 54868-4951 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20031103 ANDA ANDA065063 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 54868-4956_18a657cc-cd61-4d7d-8def-54c6ce508cd4 54868-4956 HUMAN PRESCRIPTION DRUG Denavir penciclovir CREAM TOPICAL 20031113 NDA NDA020629 Physicians Total Care, Inc. PENCICLOVIR 10 mg/g DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 54868-4957_1c304460-91d1-4710-bcc9-8c9621b36a0b 54868-4957 HUMAN PRESCRIPTION DRUG Concerta Methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20031113 NDA NDA021121 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-4958_eca9dbf4-887f-4b07-87ef-e9544fa84c4d 54868-4958 HUMAN PRESCRIPTION DRUG Mupirocin mupirocin OINTMENT TOPICAL 20031205 ANDA ANDA065192 Physicians Total Care, Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 54868-4959_79aec30f-078c-407a-b179-fa5d3e9098d2 54868-4959 HUMAN PRESCRIPTION DRUG Depakote divalproex sodium TABLET, EXTENDED RELEASE ORAL 20031118 NDA NDA021168 Physicians Total Care, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 54868-4961_a8e03fcb-e9fd-40e2-8516-febf36072b05 54868-4961 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20031119 NDA NDA020639 Physicians Total Care, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-4963_ec82c251-eebc-4210-9920-6cd5a827a177 54868-4963 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20031125 NDA NDA021366 Physicians Total Care, Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-4964_fe0547b0-9f3b-4c64-901a-66999401e26d 54868-4964 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20040303 ANDA ANDA076286 Physicians Total Care, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54868-4965_775e2b02-fe2c-4563-a982-c57f34996cc7 54868-4965 HUMAN PRESCRIPTION DRUG AVANDAMET rosiglitazone maleate and metformin hydrochloride TABLET, FILM COATED ORAL 20031204 NDA NDA021410 Physicians Total Care, Inc. ROSIGLITAZONE MALEATE; METFORMIN HYDROCHLORIDE 2; 500 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-4967_6ae08a69-c0f2-4b2c-8254-c90fb9a77c89 54868-4967 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20040127 NDA NDA021400 Physicians Total Care, Inc. VARDENAFIL HYDROCHLORIDE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 54868-4968_e899df9b-095c-4c16-895f-3307f9810383 54868-4968 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031211 NDA NDA021368 Physicians Total Care, Inc. TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 54868-4969_e387fd18-7c90-431b-8e9b-b381edb43c49 54868-4969 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET, FILM COATED ORAL 20040107 ANDA ANDA078273 Physicians Total Care, Inc. HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-4970_02240487-411f-4d1c-94b4-ce9958df78f3 54868-4970 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem CAPSULE, EXTENDED RELEASE ORAL 20091218 ANDA ANDA074984 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-4971_3e9b0b41-65ab-47e1-8790-cccf368f68aa 54868-4971 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 20050802 NDA NDA020634 Physicians Total Care, Inc. LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-4972_37f4de47-6e86-480a-912a-ccdf4ebc143a 54868-4972 HUMAN PRESCRIPTION DRUG Foradil formoterol fumarate CAPSULE RESPIRATORY (INHALATION) 20040528 NDA NDA020831 Physicians Total Care, Inc. FORMOTEROL FUMARATE 12 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-4973_faad3ce3-e3a8-415b-9396-d22c840fab0d 54868-4973 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20090529 NDA NDA022207 Physicians Total Care, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-4974_b794d466-79aa-4a4a-9fd3-f6ffc7037b72 54868-4974 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20040113 ANDA ANDA040400 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 54868-4976_a0361f5f-c7f6-4907-a525-5a953d70150f 54868-4976 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED ORAL 20050725 ANDA ANDA076604 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CIII E 20171231 54868-4977_c92105c7-4189-49dd-b3c2-88f37b80b422 54868-4977 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20040614 ANDA ANDA076007 Physicians Total Care, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-4980_3b9af72f-c970-4248-b050-fc675fbd5825 54868-4980 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET ORAL 20080116 ANDA ANDA077712 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-4981_8ea73dd1-dfe3-4628-940f-16587e605fcb 54868-4981 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20040116 NDA NDA020616 Physicians Total Care, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-4983_3b9af72f-c970-4248-b050-fc675fbd5825 54868-4983 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET ORAL 20091218 ANDA ANDA077712 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-4984_6ae08a69-c0f2-4b2c-8254-c90fb9a77c89 54868-4984 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20040305 NDA NDA021400 Physicians Total Care, Inc. VARDENAFIL HYDROCHLORIDE 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 54868-4985_c3768a3d-739f-4a72-a32f-3361beed0c8a 54868-4985 HUMAN PRESCRIPTION DRUG Celexa citalopram hydrobromide TABLET ORAL 20040130 NDA NDA020822 Physicians Total Care, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-4986_16a9da03-d763-4c90-a175-7739c59b0d16 54868-4986 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20040130 NDA NDA021286 Physicians Total Care, Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-4987_2f5eb9a3-64c5-4790-89d0-7a6c98e5f37b 54868-4987 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20040130 ANDA ANDA065308 Physicians Total Care, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-4988_845f8e7d-6ebc-4986-8cec-a4b58a0d1a69 54868-4988 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040130 ANDA ANDA076467 Physicians Total Care, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-4989_faa17132-4835-45ce-b056-0057510caa3f 54868-4989 HUMAN PRESCRIPTION DRUG Testim testosterone GEL TRANSDERMAL 20040129 NDA NDA021454 Physicians Total Care, Inc. TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 54868-4990_de49eae2-62de-4a99-be85-b5b31aaa0ddb 54868-4990 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20040129 ANDA ANDA065066 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 54868-4991_3ea83636-fc0a-4085-8693-f0f1947b5454 54868-4991 HUMAN OTC DRUG ACETAMINOPHEN pain reliever/fever reducer acetaminophen SUPPOSITORY RECTAL 20040203 ANDA ANDA070608 Physicians Total Care, Inc. ACETAMINOPHEN 650 mg/1 E 20171231 54868-4992_e5f3b0c9-1c83-47b1-8de0-375ea9719d22 54868-4992 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20040205 NDA AUTHORIZED GENERIC NDA020401 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-4997_10e409a4-8539-43f5-9081-ec58e3cbda65 54868-4997 HUMAN PRESCRIPTION DRUG Pregnyl CHORIOGONADOTROPIN ALFA KIT 20100817 NDA NDA017692 Physicians Total Care, Inc. E 20171231 54868-5000_c6d0f6d9-ea38-469c-b961-0fce271fb349 54868-5000 HUMAN PRESCRIPTION DRUG ARIMIDEX Anastrozole TABLET ORAL 20040219 NDA NDA020541 Physicians Total Care, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 54868-5001_4bea215c-7140-4209-bc87-04f71058d569 54868-5001 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040517 ANDA ANDA076211 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-5002_ce005228-bed3-4940-831b-c7f8b8256d9f 54868-5002 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate LOTION TOPICAL 20041109 ANDA ANDA018866 Physicians Total Care, Inc. BETAMETHASONE VALERATE 1 mg/mL E 20171231 54868-5005_6f09d2d9-19e9-4068-9dce-33601a0425ec 54868-5005 HUMAN PRESCRIPTION DRUG Cyclophosphamide Cyclophosphamide TABLET ORAL 19990817 ANDA ANDA040032 Physicians Total Care, Inc. CYCLOPHOSPHAMIDE 50 mg/1 E 20171231 54868-5009_6b062f20-7f3a-4161-b245-309ff37ef20f 54868-5009 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH TRANSDERMAL 20081211 ANDA ANDA075182 Physicians Total Care, Inc. ESTRADIOL 1.94 mg/48[USP'U] Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-5010_97320ca9-fbbf-4536-a667-24e225e609fb 54868-5010 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20040302 NDA NDA021515 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 54868-5011_0a9b2fd9-dfc7-45f1-b849-10caf5e9aee2 54868-5011 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, EXTENDED RELEASE ORAL 20040302 ANDA ANDA075910 Physicians Total Care, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-5013_802a50e4-5f27-474c-9680-863ecf00920b 54868-5013 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20090723 ANDA ANDA075644 Physicians Total Care, Inc. BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-5015_91fda3d6-bdfe-4dcd-84ea-32817ce41a78 54868-5015 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20040309 ANDA ANDA040353 Physicians Total Care, Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 54868-5020_9166ec18-da24-4f12-b446-dcf2dcc9d3ca 54868-5020 HUMAN PRESCRIPTION DRUG Neupogen filgrastim INJECTION, SOLUTION INTRAVENOUS 20040311 BLA BLA103353 Physicians Total Care, Inc. FILGRASTIM 300 ug/.5mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] E 20171231 54868-5021_01773720-eb77-4c73-880c-a727561fafc7 54868-5021 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20040315 ANDA ANDA077739 Physicians Total Care, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-5022_2f5eb9a3-64c5-4790-89d0-7a6c98e5f37b 54868-5022 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20040317 ANDA ANDA065308 Physicians Total Care, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-5023_e893a339-a5f4-4d9b-8854-4d972cbc8590 54868-5023 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040317 ANDA ANDA076794 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-5024_a1a2b20f-2261-4d4f-8bd8-bac39ed027bf 54868-5024 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20081014 ANDA ANDA040545 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5028_41c5a38a-eec9-4379-b253-cd06c8fd6012 54868-5028 HUMAN PRESCRIPTION DRUG Tri-Sprintec norgestimate and ethinyl estradiol KIT 20040326 ANDA ANDA075808 Physicians Total Care, Inc. E 20171231 54868-5030_bd08e4c9-d70e-4c99-bb73-1ba32248fbd9 54868-5030 HUMAN PRESCRIPTION DRUG DIFFERIN adapalene GEL TOPICAL 20040707 NDA NDA020380 Physicians Total Care, Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-5031_06466570-1478-4d94-934e-11d97c8b92c5 54868-5031 HUMAN PRESCRIPTION DRUG Velivet Triphasic Regimen Desogestrel and Ethinyl Estradiol KIT 20040326 ANDA ANDA076455 Physicians Total Care, Inc. E 20171231 54868-5033_f346e5da-59f8-462a-8d84-271d1f65f579 54868-5033 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20040329 NDA AUTHORIZED GENERIC NDA019594 Physicians Total Care, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] E 20171231 54868-5034_d86d8b95-1d16-4914-879b-8e0d9e3ba1cc 54868-5034 HUMAN PRESCRIPTION DRUG Antabuse Disulfiram TABLET ORAL 20040330 ANDA ANDA088482 Physicians Total Care, Inc. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] E 20171231 54868-5039_af1dad81-bf25-42c9-933f-e1aab296f738 54868-5039 HUMAN PRESCRIPTION DRUG Amnesteem isotretinoin CAPSULE ORAL 20101102 ANDA ANDA075945 Physicians Total Care, Inc. ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-5040_3a5158e5-a9df-4826-83bd-1b4e0922b133 54868-5040 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Physicians Total Care, Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 54868-5041_af1dad81-bf25-42c9-933f-e1aab296f738 54868-5041 HUMAN PRESCRIPTION DRUG Amnesteem isotretinoin CAPSULE ORAL 20090914 ANDA ANDA075945 Physicians Total Care, Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-5042_e711d6ee-835a-4451-b9b6-4fb3ecb5161e 54868-5042 HUMAN PRESCRIPTION DRUG Econazole Nitrate econazole nitrate CREAM TOPICAL 20040519 ANDA ANDA076075 Physicians Total Care, Inc. ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] E 20171231 54868-5043_af1dad81-bf25-42c9-933f-e1aab296f738 54868-5043 HUMAN PRESCRIPTION DRUG Amnesteem isotretinoin CAPSULE ORAL 20090714 ANDA ANDA075945 Physicians Total Care, Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-5046_9269c2d5-33df-4a96-bbc2-83c4ebeeba15 54868-5046 HUMAN PRESCRIPTION DRUG Uroxatral alfuzosin hydrochloride TABLET, EXTENDED RELEASE ORAL 20040622 NDA NDA021287 Physicians Total Care, Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-5047_28327f6d-9226-4266-bfb2-7a89715a978b 54868-5047 HUMAN PRESCRIPTION DRUG Prempro conjugated estrogens and medroxyprogesterone acetate TABLET, SUGAR COATED ORAL 20040408 NDA NDA020527 Physicians Total Care, Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .3; 1.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-5049_2b005fc8-215f-4e39-9071-f438704b3e0d 54868-5049 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY, METERED NASAL 20040412 ANDA ANDA076103 Physicians Total Care, Inc. IPRATROPIUM BROMIDE 42 ug/1 E 20171231 54868-5050_4efaae7a-6bfd-4ff3-bdad-384c7a414047 54868-5050 HUMAN PRESCRIPTION DRUG Desonide Desonide LOTION TOPICAL 20040517 ANDA ANDA072354 Physicians Total Care, Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5052_93455f35-fd9c-490d-aca4-b2becdebe5f1 54868-5052 HUMAN PRESCRIPTION DRUG NICOTROL nicotine INHALANT RESPIRATORY (INHALATION) 20040804 NDA NDA020714 Physicians Total Care, Inc. NICOTINE 4 mg/1 Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] E 20171231 54868-5054_c50edaa2-4f73-4ed5-a237-752242c00736 54868-5054 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20040426 ANDA ANDA075295 Physicians Total Care, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5055_083f09ed-bcec-4d2d-8a30-09c1b95e4708 54868-5055 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040427 ANDA ANDA076139 Physicians Total Care, Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5056_20d39fb1-12c2-4010-8010-ef55d8f48a08 54868-5056 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20040427 ANDA ANDA076466 Physicians Total Care, Inc. METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 54868-5058_b8427898-2a74-41d0-aed2-4839df76e139 54868-5058 HUMAN PRESCRIPTION DRUG Cytomel liothyronine sodium TABLET ORAL 20040503 NDA NDA010379 Physicians Total Care, Inc. LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] E 20171231 54868-5064_083f09ed-bcec-4d2d-8a30-09c1b95e4708 54868-5064 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040518 ANDA ANDA076139 Physicians Total Care, Inc. FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5067_fed8d510-c787-407c-8748-a41c6e8cc4a0 54868-5067 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20090129 ANDA ANDA084903 Physicians Total Care, Inc. PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-5070_26b73aa5-c8dc-449d-9162-fb10dcc110e8 54868-5070 HUMAN PRESCRIPTION DRUG Glucagon glucagon KIT 20040524 NDA NDA020928 Physicians Total Care, Inc. E 20171231 54868-5071_bff287d0-e71f-4fe8-bf73-5100a2432a2f 54868-5071 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 20040524 ANDA ANDA075319 Physicians Total Care, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-5072_8549813a-3660-43e2-ae37-674c4c9f7ef2 54868-5072 HUMAN PRESCRIPTION DRUG Astelin Azelastine Hydrochloride SPRAY, METERED NASAL 20040525 NDA NDA020114 Physicians Total Care, Inc. AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 54868-5074_87b9641a-07be-4e3d-84a8-a9f2b8c19a77 54868-5074 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20040630 ANDA ANDA076278 Physicians Total Care, Inc. FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] E 20171231 54868-5075_853c3980-7c9b-4c59-805f-5e5ff232a59a 54868-5075 HUMAN PRESCRIPTION DRUG Benicar Hct olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20040601 NDA NDA021532 Physicians Total Care, Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5077_60b11c09-e7ec-4f59-97b9-8a4237840578 54868-5077 HUMAN PRESCRIPTION DRUG Cozaar losartan potassium TABLET, FILM COATED ORAL 20040602 NDA NDA020386 Physicians Total Care, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-5078_853c3980-7c9b-4c59-805f-5e5ff232a59a 54868-5078 HUMAN PRESCRIPTION DRUG Benicar Hct olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20040602 NDA NDA021532 Physicians Total Care, Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5079_4bea215c-7140-4209-bc87-04f71058d569 54868-5079 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040825 ANDA ANDA076211 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-5080_325a1e76-23a1-47e2-961c-e1c21e9a0ea7 54868-5080 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20040817 ANDA ANDA075356 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5081_02240487-411f-4d1c-94b4-ce9958df78f3 54868-5081 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem CAPSULE, EXTENDED RELEASE ORAL 20040603 ANDA ANDA074984 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-5082_7c4c1776-6fe6-419a-9eb6-3e365693efa3 54868-5082 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20070917 NDA NDA021283 Physicians Total Care, Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-5085_ec82c251-eebc-4210-9920-6cd5a827a177 54868-5085 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20040607 NDA NDA021366 Physicians Total Care, Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5095_802a50e4-5f27-474c-9680-863ecf00920b 54868-5095 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20090807 ANDA ANDA075644 Physicians Total Care, Inc. BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-5099_e9a7e3b9-6030-4189-ba01-32261559e4f6 54868-5099 HUMAN PRESCRIPTION DRUG Mavik Trandolapril TABLET ORAL 20040625 NDA NDA020528 Physicians Total Care, Inc. TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5100_13b193d2-e076-491d-b20c-c5c8d7d8a47c 54868-5100 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET ORAL 20090723 ANDA ANDA076486 Physicians Total Care, Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5101_db05df82-8297-4bea-9036-dc5d651cac72 54868-5101 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20100225 ANDA ANDA065378 Physicians Total Care, Inc. AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-5103_e1ec8388-3aeb-4259-8201-486191f06c84 54868-5103 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20040707 ANDA ANDA040440 Physicians Total Care, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5104_20d39fb1-12c2-4010-8010-ef55d8f48a08 54868-5104 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20040706 ANDA ANDA076732 Physicians Total Care, Inc. METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 54868-5108_199662a5-c92a-43ca-88ff-38e30bc6c3b9 54868-5108 HUMAN PRESCRIPTION DRUG Humalog Insulin lispro INJECTION, SOLUTION SUBCUTANEOUS 20050502 NDA NDA020563 Physicians Total Care, Inc. INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 54868-5109_ca587c20-50ac-4f59-96f6-5b1e1505722f 54868-5109 HUMAN PRESCRIPTION DRUG Spiriva tiotropium bromide monohydrate CAPSULE ORAL; RESPIRATORY (INHALATION) 20040714 NDA NDA021395 Physicians Total Care, Inc. TIOTROPIUM BROMIDE MONOHYDRATE 18 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 54868-5110_83416fe4-d127-4a91-b127-29c37a6979f2 54868-5110 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20040715 OTC MONOGRAPH FINAL part331 Physicians Total Care, Inc. MAGNESIUM OXIDE 400 mg/1 E 20171231 54868-5112_cf63553d-cb67-44c0-8c5f-44683f9a30ac 54868-5112 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20040728 NDA NDA020164 Physicians Total Care, Inc. ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 54868-5113_c14d08c7-47b9-4209-9adb-0f8500f29564 54868-5113 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20041006 ANDA ANDA074821 Physicians Total Care, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5114_c00a9dd4-45c6-4de5-bfb7-9abdaac6bbcd 54868-5114 HUMAN PRESCRIPTION DRUG Avodart dutasteride CAPSULE, LIQUID FILLED ORAL 20040716 NDA NDA021319 Physicians Total Care, Inc. DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 54868-5118_8e25e51e-51b0-48d2-b47a-34189bcfec7c 54868-5118 HUMAN PRESCRIPTION DRUG IMITREX sumatriptan succinate TABLET, FILM COATED ORAL 20040714 NDA NDA020132 Physicians Total Care, Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 54868-5119_20d39fb1-12c2-4010-8010-ef55d8f48a08 54868-5119 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20040720 ANDA ANDA076466 Physicians Total Care, Inc. METOLAZONE 10 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 54868-5121_b0edb786-44c1-43ea-afc0-78df4970ce86 54868-5121 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20050523 ANDA ANDA040863 Physicians Total Care, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 54868-5124_9061bcf0-3933-4af1-8a72-71602eb59c0c 54868-5124 HUMAN PRESCRIPTION DRUG VANIQA eflornithine hydrochloride CREAM TOPICAL 20040726 NDA NDA021145 Physicians Total Care, Inc. EFLORNITHINE HYDROCHLORIDE 139 mg/g Antiprotozoal [EPC],Decarboxylase Inhibitor [EPC],Decarboxylase Inhibitors [MoA] E 20171231 54868-5126_3056bc9b-abd8-4f5a-bb6b-4acb629afac5 54868-5126 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20040903 NDA NDA021228 Physicians Total Care, Inc. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-5129_3d4b67bb-e159-4b4f-aa17-624515cd639f 54868-5129 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 20040812 NDA AUTHORIZED GENERIC NDA019949 Physicians Total Care, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 54868-5130_fe5d59ac-8d14-4dc8-9b84-3e0c90e0da7a 54868-5130 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20040809 ANDA ANDA076673 Physicians Total Care, Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-5132_c50edaa2-4f73-4ed5-a237-752242c00736 54868-5132 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20040810 ANDA ANDA075295 Physicians Total Care, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5139_3883e227-acaf-4daf-8319-6dc2fb5b6293 54868-5139 HUMAN PRESCRIPTION DRUG Sonata zaleplon CAPSULE ORAL 20070905 NDA NDA020859 Physicians Total Care, Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 54868-5140_bdecce86-e035-472d-8131-180414c321fe 54868-5140 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20040816 NDA NDA021303 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5141_f38902d1-0634-4845-beb8-334086f7a64c 54868-5141 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20040802 NDA NDA021752 Physicians Total Care, Inc. EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 54868-5142_bdecce86-e035-472d-8131-180414c321fe 54868-5142 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20040823 NDA NDA021303 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5143_37a9009f-2b28-49bc-9ca7-47193bb56554 54868-5143 HUMAN PRESCRIPTION DRUG Aggrenox aspirin and dipyridamole CAPSULE ORAL 20040824 NDA NDA020884 Physicians Total Care, Inc. ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 54868-5144_3d4b67bb-e159-4b4f-aa17-624515cd639f 54868-5144 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 20040812 NDA AUTHORIZED GENERIC NDA019949 Physicians Total Care, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 54868-5146_b794d466-79aa-4a4a-9fd3-f6ffc7037b72 54868-5146 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20040902 ANDA ANDA040409 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 54868-5148_613f1eee-3018-45a8-a196-164c9d37a732 54868-5148 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20110102 ANDA ANDA076345 Physicians Total Care, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-5157_775e2b02-fe2c-4563-a982-c57f34996cc7 54868-5157 HUMAN PRESCRIPTION DRUG AVANDAMET rosiglitazone maleate and metformin hydrochloride TABLET, FILM COATED ORAL 20060825 NDA NDA021410 Physicians Total Care, Inc. ROSIGLITAZONE MALEATE; METFORMIN HYDROCHLORIDE 4; 500 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-5160_20fbadcf-d7c0-4336-b61f-8980c79e35cb 54868-5160 HUMAN PRESCRIPTION DRUG POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 POWDER ORAL 20041007 ANDA ANDA076652 Physicians Total Care, Inc. POLYETHYLENE GLYCOL 3350 1 g/g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 54868-5162_2babd42d-0704-4744-91e6-ff80911874d5 54868-5162 HUMAN PRESCRIPTION DRUG BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE codeine phosphate, butalbital, caffeine, and acetaminophen capsule CAPSULE ORAL 20090706 ANDA ANDA020232 Physicians Total Care, Inc. CODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ACETAMINOPHEN 30; 50; 40; 325 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII E 20171231 54868-5165_d20fb9f1-0b8c-413b-b733-030857928fd3 54868-5165 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20081013 ANDA ANDA065358 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 54868-5166_262588dd-98d4-4859-8ea6-032744c9a832 54868-5166 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20060829 ANDA ANDA078428 Physicians Total Care, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-5167_908a86d2-aa73-435f-8a10-843670316df1 54868-5167 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20041122 ANDA ANDA040405 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 54868-5168_06c6c6a9-b6d8-4107-b2b0-494705ef260d 54868-5168 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP ORAL 20071107 ANDA ANDA040613 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] CIII E 20171231 54868-5170_853c3980-7c9b-4c59-805f-5e5ff232a59a 54868-5170 HUMAN PRESCRIPTION DRUG Benicar Hct olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20041015 NDA NDA021532 Physicians Total Care, Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5171_ce3e7997-b925-4b07-994e-b2e699e0d3a1 54868-5171 HUMAN PRESCRIPTION DRUG Ketek telithromycin TABLET, FILM COATED ORAL 20041027 NDA NDA021144 Physicians Total Care, Inc. TELITHROMYCIN 400 mg/1 Ketolide Antibacterial [EPC],Ketolides [Chemical/Ingredient] E 20171231 54868-5175_de49eae2-62de-4a99-be85-b5b31aaa0ddb 54868-5175 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20050316 ANDA ANDA065066 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 54868-5178_dadf8ed3-b155-4449-a74e-1ebdf9b10a06 54868-5178 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20080118 ANDA ANDA077031 Physicians Total Care, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5179_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5179 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20041111 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5180_3a76a4d0-bd0f-409e-adf0-0cbaae53243c 54868-5180 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20050401 ANDA ANDA079234 Physicians Total Care, Inc. TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 54868-5182_083f09ed-bcec-4d2d-8a30-09c1b95e4708 54868-5182 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20041118 ANDA ANDA076139 Physicians Total Care, Inc. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5183_3f8e1db1-b2e1-4b1f-a1a9-863715d303a2 54868-5183 HUMAN PRESCRIPTION DRUG Terconazole terconazole CREAM VAGINAL 20041118 ANDA ANDA075953 Physicians Total Care, Inc. TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] E 20171231 54868-5185_613f1eee-3018-45a8-a196-164c9d37a732 54868-5185 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20041119 ANDA ANDA076345 Physicians Total Care, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-5186_641276ef-a0de-4184-ad36-030a96acb7d1 54868-5186 HUMAN PRESCRIPTION DRUG PACERONE amiodarone hydrochloride TABLET ORAL 20081022 ANDA ANDA075135 Physicians Total Care, Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 54868-5187_03da19ea-d024-469b-a606-892170bb9ccd 54868-5187 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20041119 NDA NDA021687 Physicians Total Care, Inc. EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5188_723ef500-4b12-4d0d-b926-ae59e21fe0e0 54868-5188 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051114 ANDA ANDA077270 Physicians Total Care, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-5189_03da19ea-d024-469b-a606-892170bb9ccd 54868-5189 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20041119 NDA NDA021687 Physicians Total Care, Inc. EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5190_1464cdb0-3223-4e7b-81fb-c9f1b4a57f0f 54868-5190 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 20041129 NDA NDA020505 Physicians Total Care, Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-5192_334e3947-0fd2-49b0-ba27-cc2a8ab32e47 54868-5192 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20091123 NDA NDA021427 Physicians Total Care, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5194_2b5040b4-a52f-441b-a299-fec130b3d826 54868-5194 HUMAN PRESCRIPTION DRUG LIDOCAINE AND PRILOCAINE Lidocaine and Prilocaine CREAM TOPICAL 20041210 ANDA ANDA076453 Physicians Total Care, Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 54868-5195_884529eb-1b8a-4891-b377-e28ad5cf0bdd 54868-5195 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20041216 ANDA ANDA077662 Physicians Total Care, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-5197_f25888eb-e871-4f73-a93d-cfda73a099c2 54868-5197 HUMAN PRESCRIPTION DRUG Felodipine felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050322 ANDA ANDA075896 Physicians Total Care, Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 54868-5200_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5200 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20041227 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5201_ca8c3e5e-b0aa-498e-becd-02cdb41714df 54868-5201 HUMAN PRESCRIPTION DRUG NovoLog Mix 70/30 insulin aspart INJECTION, SUSPENSION SUBCUTANEOUS 20041228 NDA NDA021172 Physicians Total Care, Inc. INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 54868-5202_749ca7b2-0317-497a-bc36-167f5c02dbf3 54868-5202 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20060131 NDA NDA021436 Physicians Total Care, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-5203_044e1d60-69dd-4322-91bd-c16f69f3255c 54868-5203 HUMAN PRESCRIPTION DRUG Tricor fenofibrate TABLET ORAL 20041229 NDA NDA021656 Physicians Total Care, Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 54868-5204_4bea215c-7140-4209-bc87-04f71058d569 54868-5204 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20050105 ANDA ANDA076211 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-5208_e5f3b0c9-1c83-47b1-8de0-375ea9719d22 54868-5208 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050117 NDA AUTHORIZED GENERIC NDA020401 Physicians Total Care, Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 54868-5209_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5209 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20050118 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5210_845f8e7d-6ebc-4986-8cec-a4b58a0d1a69 54868-5210 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050118 ANDA ANDA076467 Physicians Total Care, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-5211_d1a436e2-b35a-4bf2-9386-da4190a4c03e 54868-5211 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20050419 ANDA ANDA065061 Physicians Total Care, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 54868-5213_943821b5-8382-43e2-a18b-ac8e9cde746e 54868-5213 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20050225 ANDA ANDA040256 Physicians Total Care, Inc. PREDNISONE 5 mg/1 E 20171231 54868-5214_fec9fd56-f868-4a25-8558-75afcc8e2005 54868-5214 HUMAN PRESCRIPTION DRUG AMILORIDE HYDROCHLORIDE amiloride hydrochloride TABLET ORAL 20050128 NDA NDA018200 Physicians Total Care, Inc. AMILORIDE HYDROCHLORIDE 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] E 20171231 54868-5215_334e3947-0fd2-49b0-ba27-cc2a8ab32e47 54868-5215 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20080428 NDA NDA021427 Physicians Total Care, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5216_7321055b-ecac-44c6-a253-b34d65893a53 54868-5216 HUMAN PRESCRIPTION DRUG Nystatin nystatin POWDER TOPICAL 20050127 ANDA ANDA064118 Physicians Total Care, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 54868-5217_6cf43b6a-adb3-4151-8212-3fecde2f14f3 54868-5217 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-5218_6f09d2d9-19e9-4068-9dce-33601a0425ec 54868-5218 HUMAN PRESCRIPTION DRUG Cyclophosphamide Cyclophosphamide TABLET ORAL 19990817 ANDA ANDA040032 Physicians Total Care, Inc. CYCLOPHOSPHAMIDE 25 mg/1 E 20171231 54868-5219_884529eb-1b8a-4891-b377-e28ad5cf0bdd 54868-5219 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20050214 ANDA ANDA077662 Physicians Total Care, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-5224_044e1d60-69dd-4322-91bd-c16f69f3255c 54868-5224 HUMAN PRESCRIPTION DRUG Tricor fenofibrate TABLET ORAL 20050216 NDA NDA021656 Physicians Total Care, Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 54868-5226_262588dd-98d4-4859-8ea6-032744c9a832 54868-5226 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20090924 ANDA ANDA078428 Physicians Total Care, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-5230_997397d5-0c64-459e-88f3-d8c289b37367 54868-5230 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20050225 ANDA ANDA040256 Physicians Total Care, Inc. PREDNISONE 10 mg/1 E 20171231 54868-5231_f9ed7c72-2852-43af-ad96-a591f943f92f 54868-5231 HUMAN PRESCRIPTION DRUG EMEND aprepitant CAPSULE ORAL 20050629 NDA NDA021549 Physicians Total Care, Inc. APREPITANT 80 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] E 20171231 54868-5232_80b4b640-1b66-41c8-ac0b-9cb14780db7f 54868-5232 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate LOTION TOPICAL 20071231 ANDA ANDA076493 Physicians Total Care, Inc. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .64 mg/mL; mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5233_8552760b-6f1f-4ce3-bf29-4f3c5c11da05 54868-5233 HUMAN PRESCRIPTION DRUG Protopic Tacrolimus OINTMENT TOPICAL 20080508 NDA NDA050777 Physicians Total Care, Inc. TACROLIMUS 1 mg/g E 20171231 54868-5234_906db94a-6285-451c-a3a9-4b5da597eed1 54868-5234 HUMAN PRESCRIPTION DRUG Griseofulvin griseofulvin SUSPENSION ORAL 20060116 ANDA ANDA062483 Physicians Total Care, Inc. GRISEOFULVIN 125 mg/5mL Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] E 20171231 54868-5236_484a0faa-15e4-4004-9d85-0d6e798da9a5 54868-5236 HUMAN PRESCRIPTION DRUG Finacea azelaic acid GEL TOPICAL 20050303 NDA NDA021470 Physicians Total Care, Inc. AZELAIC ACID .15 g/g Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE] E 20171231 54868-5239_21430706-61d3-4a2b-9e2a-d6f5d33a16c1 54868-5239 HUMAN PRESCRIPTION DRUG LITHIUM CARBONATE Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20050301 ANDA ANDA076832 Physicians Total Care, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 54868-5240_7c89711c-07e8-404e-9946-bdaefdff3df1 54868-5240 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20050303 NDA NDA020823 Physicians Total Care, Inc. RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 54868-5241_5b1397ab-09e0-41ef-b310-6967cfa4d4c4 54868-5241 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20050303 ANDA ANDA076607 Physicians Total Care, Inc. QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5242_057ab8c4-3358-4eae-af12-3a57116c51a0 54868-5242 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20050303 ANDA ANDA076913 Physicians Total Care, Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5243_613f1eee-3018-45a8-a196-164c9d37a732 54868-5243 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20050307 ANDA ANDA076345 Physicians Total Care, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-5245_5b1397ab-09e0-41ef-b310-6967cfa4d4c4 54868-5245 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20050307 ANDA ANDA076607 Physicians Total Care, Inc. QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5246_5b1397ab-09e0-41ef-b310-6967cfa4d4c4 54868-5246 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20071128 ANDA ANDA076607 Physicians Total Care, Inc. QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5248_3d4b67bb-e159-4b4f-aa17-624515cd639f 54868-5248 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole POWDER, FOR SUSPENSION ORAL 20050311 NDA AUTHORIZED GENERIC NDA020090 Physicians Total Care, Inc. FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 54868-5249_1bbc11e0-ee07-4207-9cd9-6cba1a83be90 54868-5249 HUMAN PRESCRIPTION DRUG Avandia rosiglitazone maleate TABLET, FILM COATED ORAL 20050513 NDA NDA021071 Physicians Total Care, Inc. ROSIGLITAZONE MALEATE 2 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 54868-5250_03da19ea-d024-469b-a606-892170bb9ccd 54868-5250 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20050314 NDA NDA021687 Physicians Total Care, Inc. EZETIMIBE; SIMVASTATIN 10; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5251_7376e718-265d-4d1c-9eea-d044aaf034fe 54868-5251 HUMAN PRESCRIPTION DRUG Hydrocortisone Valerate Hydrocortisone Valerate OINTMENT TOPICAL 20050315 ANDA ANDA075043 Physicians Total Care, Inc. HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5255_d975e88b-476c-463b-9600-3fbcdb0e86f2 54868-5255 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20050323 NDA NDA009218 Physicians Total Care, Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-5256_2d55557e-ec94-4ae4-aa0b-f35df835b961 54868-5256 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20050324 ANDA ANDA076631 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5257_1e55e0e7-d2d6-40f2-8d84-66cf9768c737 54868-5257 HUMAN PRESCRIPTION DRUG MEDROXYPROGESTERONE ACETATE medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 20050331 NDA NDA020246 Physicians Total Care, Inc. MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-5258_c6d171e1-6765-4e8a-833e-7b071efd94ed 54868-5258 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20050404 ANDA ANDA040663 Physicians Total Care, Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 54868-5259_03da19ea-d024-469b-a606-892170bb9ccd 54868-5259 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20050404 NDA NDA021687 Physicians Total Care, Inc. EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5260_16881b74-dac8-403b-8a75-b1ca2732ab11 54868-5260 HUMAN PRESCRIPTION DRUG Xeloda capecitabine TABLET, FILM COATED ORAL 20050628 NDA NDA020896 Physicians Total Care, Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 54868-5261_5680d1f0-5242-42a9-a64e-2cd387a6ee96 54868-5261 HUMAN PRESCRIPTION DRUG Aromasin exemestane TABLET ORAL 20050629 NDA NDA020753 Physicians Total Care, Inc. EXEMESTANE 25 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 54868-5266_447e39ea-78d1-47f1-80f0-a95bdc4ed962 54868-5266 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20050415 NDA NDA021035 Physicians Total Care, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-5268_a19e649e-2636-4708-b3f0-3d2ebcbffb2d 54868-5268 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20050418 ANDA ANDA076301 Physicians Total Care, Inc. LORATADINE 10 mg/1 E 20171231 54868-5269_63f46afc-ac6d-4391-bcd0-7b17fc6e8dea 54868-5269 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20050420 ANDA ANDA065134 Physicians Total Care, Inc. DOXYCYCLINE HYCLATE 20 mg/1 E 20171231 54868-5270_3503c781-8fbd-424c-a9f4-17212e8a723b 54868-5270 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine ciclopirox olamine CREAM TOPICAL 20050401 ANDA ANDA076790 Physicians Total Care, Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] E 20171231 54868-5271_d972a09a-e421-403c-b9bf-9cbd738fa99c 54868-5271 HUMAN PRESCRIPTION DRUG Differin adapalene CREAM TOPICAL 20050419 NDA NDA020748 Physicians Total Care, Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-5273_9bd52b97-5d46-4329-849f-7a49ebdbb8c7 54868-5273 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050427 NDA NDA021476 Physicians Total Care, Inc. ESZOPICLONE 2 mg/1 CIV E 20171231 54868-5274_14d86267-3396-4311-9f0b-64fe41fbb8cb 54868-5274 HUMAN PRESCRIPTION DRUG Etodolac etodolac CAPSULE ORAL 20050427 ANDA ANDA075078 Physicians Total Care, Inc. ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-5275_dadf8ed3-b155-4449-a74e-1ebdf9b10a06 54868-5275 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20100114 ANDA ANDA077031 Physicians Total Care, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5279_5b1397ab-09e0-41ef-b310-6967cfa4d4c4 54868-5279 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20050722 ANDA ANDA076607 Physicians Total Care, Inc. QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5281_5e8eb86c-a083-49e9-9562-e45d3e5c7f13 54868-5281 HUMAN PRESCRIPTION DRUG Teveten HCT Eprosartan Mesylate and Hydrochlorothiazide TABLET ORAL 20050506 NDA NDA021268 Physicians Total Care, Inc. EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE 600; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5282_34d636a5-b7c9-41dc-83be-85caf213096f 54868-5282 HUMAN PRESCRIPTION DRUG mercaptopurine mercaptopurine TABLET ORAL 20050523 ANDA ANDA040461 Physicians Total Care, Inc. MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 54868-5286_fb1f04a2-345a-44cd-ac48-a0cc5bc70a06 54868-5286 HUMAN PRESCRIPTION DRUG Nortrel 7/7/7 (28 Day Regimen) Norethindrone and Ethinyl Estradiol KIT 20080819 ANDA ANDA075478 Physicians Total Care, Inc. E 20171231 54868-5287_ef488235-15c6-4466-8540-5f30e365ab68 54868-5287 HUMAN OTC DRUG Calmoseptine Zinc Oxide and menthol OINTMENT TOPICAL 20060719 OTC MONOGRAPH FINAL part347 Physicians Total Care, Inc. ZINC OXIDE; MENTHOL 20.6; .44 g/113g; g/113g E 20171231 54868-5290_fb809355-146a-4baf-a029-a80b7faee7bb 54868-5290 HUMAN PRESCRIPTION DRUG Tarceva erlotinib hydrochloride TABLET ORAL 20050701 NDA NDA021743 Physicians Total Care, Inc. ERLOTINIB HYDROCHLORIDE 25 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] E 20171231 54868-5291_176d3ea3-8f7f-4827-a347-9676bf861d68 54868-5291 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen tramadol hydrochloride and acetaminophen TABLET ORAL 20050512 ANDA ANDA076475 Physicians Total Care, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 54868-5292_5fb1d869-76bb-4298-acf8-d318208d91e5 54868-5292 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SOLUTION TOPICAL 20050512 ANDA ANDA074222 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .462 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5295_8b910c5e-691b-492d-95df-bb01fd6b0c4f 54868-5295 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 20050516 ANDA ANDA074172 Physicians Total Care, Inc. NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-5296_2d55557e-ec94-4ae4-aa0b-f35df835b961 54868-5296 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20050516 ANDA ANDA076631 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5297_e8331ace-719a-4405-97f1-fb137e7c2444 54868-5297 HUMAN PRESCRIPTION DRUG Micardis HCT TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET ORAL 20050630 NDA NDA021162 Physicians Total Care, Inc. TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5299_e1216318-f183-4a90-8265-8bb6a58cc5d2 54868-5299 HUMAN PRESCRIPTION DRUG SUCRALFATE Sucralfate SUSPENSION ORAL 20050524 NDA NDA019183 Physicians Total Care, Inc. SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] E 20171231 54868-5303_183fd856-868e-459a-8361-66ca5ac363e3 54868-5303 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20050517 NDA NDA021428 Physicians Total Care, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 54868-5307_580d387f-c4ba-4a04-b664-8b93aa6fe483 54868-5307 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin Phosphate CREAM VAGINAL 20050519 ANDA ANDA065139 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 54868-5308_c493f7e4-0466-4ae6-acf9-26734af024bc 54868-5308 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20050523 ANDA ANDA079096 Physicians Total Care, Inc. NAPROXEN SODIUM 220 mg/1 E 20171231 54868-5309_3ab3af08-bbd8-4fe4-ba32-971374fe2b30 54868-5309 HUMAN OTC DRUG Prilosec OTC omeprazole magnesium TABLET, DELAYED RELEASE ORAL 20050523 NDA NDA021229 Physicians Total Care, Inc. OMEPRAZOLE MAGNESIUM 20.6 mg/1 E 20171231 54868-5310_7621a198-f26d-4f41-bba6-5d9d2088a7c1 54868-5310 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20050523 ANDA ANDA077621 Physicians Total Care, Inc. AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] E 20171231 54868-5311_3f280d6c-7cf4-47c4-8b1f-3a6218a7cf84 54868-5311 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050527 NDA NDA020591 Physicians Total Care, Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-5312_dba74198-1341-41e1-9f6e-a756104c434b 54868-5312 HUMAN PRESCRIPTION DRUG Levothroid LEVOTHYROXINE SODIUM TABLET ORAL 20050520 NDA NDA021116 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-5313_78f83075-c908-4385-8690-9ff0a573ff17 54868-5313 HUMAN PRESCRIPTION DRUG Lotensin HCT benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20050523 NDA NDA020033 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5315_334e3947-0fd2-49b0-ba27-cc2a8ab32e47 54868-5315 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20081121 NDA NDA021427 Physicians Total Care, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5320_3f280d6c-7cf4-47c4-8b1f-3a6218a7cf84 54868-5320 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090625 NDA NDA020591 Physicians Total Care, Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-5322_6a4ba197-e3bc-4e54-9a33-bc48bb880d49 54868-5322 HUMAN PRESCRIPTION DRUG Boniva ibandronate sodium TABLET, FILM COATED ORAL 20050602 NDA NDA021455 Physicians Total Care, Inc. IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 54868-5323_745ce298-abcb-4d11-8c0e-79776cdc6e2e 54868-5323 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20081125 NDA NDA020818 Physicians Total Care, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5325_f9ed7c72-2852-43af-ad96-a591f943f92f 54868-5325 HUMAN PRESCRIPTION DRUG Emend aprepitant KIT 20050624 NDA NDA021549 Physicians Total Care, Inc. E 20171231 54868-5326_01fd5716-bb59-49b0-a0ed-8da299cf060f 54868-5326 HUMAN PRESCRIPTION DRUG Junel Fe 1/20 norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20050603 ANDA ANDA076081 Physicians Total Care, Inc. E 20171231 54868-5327_ca8c3e5e-b0aa-498e-becd-02cdb41714df 54868-5327 HUMAN PRESCRIPTION DRUG NovoLog Mix 70/30 insulin aspart INJECTION, SUSPENSION SUBCUTANEOUS 20110517 NDA NDA021172 Physicians Total Care, Inc. INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 54868-5334_cee4126c-21b9-4f7c-b85f-cd2838d19d3e 54868-5334 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20050613 ANDA ANDA040700 Physicians Total Care, Inc. DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5336_ab9d67ba-3e66-4664-a376-b65a4bfa7331 54868-5336 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20050614 NDA NDA020592 Physicians Total Care, Inc. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-5337_74ba7709-016b-437d-be8e-2dc3c28d724e 54868-5337 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate CREAM TOPICAL 20060913 ANDA ANDA076793 Physicians Total Care, Inc. FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5338_a1a2b20f-2261-4d4f-8bd8-bac39ed027bf 54868-5338 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20081014 ANDA ANDA040545 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5339_7c89711c-07e8-404e-9946-bdaefdff3df1 54868-5339 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20050617 NDA NDA020823 Physicians Total Care, Inc. RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 54868-5340_e481894d-6e16-4823-8399-91fccce085af 54868-5340 HUMAN PRESCRIPTION DRUG LITHIUM CARBONATE Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20050622 ANDA ANDA076490 Physicians Total Care, Inc. LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] E 20171231 54868-5341_ec82c251-eebc-4210-9920-6cd5a827a177 54868-5341 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20050622 NDA NDA021366 Physicians Total Care, Inc. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5343_1464cdb0-3223-4e7b-81fb-c9f1b4a57f0f 54868-5343 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 20050705 NDA NDA020505 Physicians Total Care, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-5345_3d4b67bb-e159-4b4f-aa17-624515cd639f 54868-5345 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 20050706 NDA AUTHORIZED GENERIC NDA019949 Physicians Total Care, Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 54868-5346_618032df-c98a-47c7-a522-a42f5bd3e1d2 54868-5346 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20050706 ANDA ANDA090228 Physicians Total Care, Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5347_52f498a2-11b0-46be-bb67-14054aa3c2c5 54868-5347 HUMAN PRESCRIPTION DRUG PAXILCR CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050706 NDA NDA020936 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5348_cef15d8b-d8c6-491e-9549-695ddc33892b 54868-5348 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 20051020 NDA NDA021029 Physicians Total Care, Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 54868-5350_cef15d8b-d8c6-491e-9549-695ddc33892b 54868-5350 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 20051007 NDA NDA021029 Physicians Total Care, Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 54868-5351_7afd87aa-acc7-459e-8c50-a6e663a3455e 54868-5351 HUMAN PRESCRIPTION DRUG Derma-Smoothe/FS fluocinolone acetonide OIL TOPICAL 20090903 NDA NDA019452 Physicians Total Care, Inc. FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5354_cef15d8b-d8c6-491e-9549-695ddc33892b 54868-5354 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 20060413 NDA NDA021029 Physicians Total Care, Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 54868-5356_962db524-45ec-4e36-8aab-8ed2e5a697fc 54868-5356 HUMAN PRESCRIPTION DRUG AVIANE levonorgestrel and ethinyl estradiol KIT 20050708 ANDA ANDA075796 Physicians Total Care, Inc. E 20171231 54868-5362_e545053a-9ad5-48f1-94c5-8ae86735e581 54868-5362 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20050713 NDA NDA021433 Physicians Total Care, Inc. FLUTICASONE PROPIONATE 110 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5363_931dca5a-f555-459e-8f09-ae71f80b8960 54868-5363 HUMAN PRESCRIPTION DRUG Enablex darifenacin TABLET, EXTENDED RELEASE ORAL 20050720 NDA NDA021513 Physicians Total Care, Inc. DARIFENACIN 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-5364_845f8e7d-6ebc-4986-8cec-a4b58a0d1a69 54868-5364 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050725 ANDA ANDA076467 Physicians Total Care, Inc. GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-5365_52f498a2-11b0-46be-bb67-14054aa3c2c5 54868-5365 HUMAN PRESCRIPTION DRUG PAXILCR CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050721 NDA NDA020936 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5368_bdecce86-e035-472d-8131-180414c321fe 54868-5368 HUMAN PRESCRIPTION DRUG Adderall XR Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate CAPSULE, EXTENDED RELEASE ORAL 20020726 NDA NDA021303 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5376_775e2b02-fe2c-4563-a982-c57f34996cc7 54868-5376 HUMAN PRESCRIPTION DRUG AVANDAMET rosiglitazone maleate and metformin hydrochloride TABLET, FILM COATED ORAL 20050803 NDA NDA021410 Physicians Total Care, Inc. ROSIGLITAZONE MALEATE; METFORMIN HYDROCHLORIDE 2; 1000 mg/1; mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-5377_e4fe38fa-19f0-4476-9723-e51767dfeb78 54868-5377 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20070410 ANDA ANDA075932 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 54868-5381_f04083e0-111f-455c-ab72-35303192530a 54868-5381 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 NDA NDA020741 Physicians Total Care, Inc. REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] E 20171231 54868-5384_e0cceca4-759d-4ca9-be65-23a0199e5766 54868-5384 HUMAN PRESCRIPTION DRUG BYETTA exenatide INJECTION SUBCUTANEOUS 20050809 NDA NDA021773 Physicians Total Care, Inc. EXENATIDE 250 ug/mL GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [Chemical/Ingredient],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] E 20171231 54868-5387_e1ec8388-3aeb-4259-8201-486191f06c84 54868-5387 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate TABLET ORAL 20050811 ANDA ANDA040440 Physicians Total Care, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5388_9fc8399c-25aa-492f-bc7b-596cbae4d39c 54868-5388 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20050815 ANDA ANDA076137 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5389_39263f83-7ec6-4fa7-a861-1e9897ab7c48 54868-5389 HUMAN PRESCRIPTION DRUG MEGESTROL ACETATE megestrol acetate SUSPENSION ORAL 20050901 ANDA ANDA075671 Physicians Total Care, Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-5390_3b9af72f-c970-4248-b050-fc675fbd5825 54868-5390 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET ORAL 20081001 ANDA ANDA077712 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5391_d43f9c40-5039-42e9-871d-286bbb26cc68 54868-5391 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20071030 ANDA ANDA076369 Physicians Total Care, Inc. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] E 20171231 54868-5392_4bea215c-7140-4209-bc87-04f71058d569 54868-5392 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20050819 ANDA ANDA076211 Physicians Total Care, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-5394_9bd52b97-5d46-4329-849f-7a49ebdbb8c7 54868-5394 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050824 NDA NDA021476 Physicians Total Care, Inc. ESZOPICLONE 3 mg/1 CIV E 20171231 54868-5397_79201e83-d9e6-42a7-98b6-bd51edbdc233 54868-5397 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20050826 NDA NDA021259 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5398_b5a4afc1-5622-4146-b1af-66f54f922425 54868-5398 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050829 NDA NDA021518 Physicians Total Care, Inc. SOLIFENACIN SUCCINATE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-5400_ba80da42-fe66-4664-b91b-3ad6f83ad3b2 54868-5400 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE metoprolol tartrate and hydrochlorothiazide TABLET ORAL 20050901 ANDA ANDA076792 Physicians Total Care, Inc. METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5401_fbfd8785-c77f-438a-9f62-251362dc80a7 54868-5401 HUMAN PRESCRIPTION DRUG Klaron sulfacetamide sodium LOTION TOPICAL 20050901 NDA NDA019931 Physicians Total Care, Inc. SULFACETAMIDE SODIUM 10 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 54868-5405_87b9641a-07be-4e3d-84a8-a9f2b8c19a77 54868-5405 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20050902 ANDA ANDA076278 Physicians Total Care, Inc. FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] E 20171231 54868-5409_de4c4a2a-bfa3-4149-a524-e90623c34ce1 54868-5409 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20070404 ANDA ANDA020872 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 54868-5411_22f68cbf-a96c-442a-a124-082f276cd6c3 54868-5411 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20050909 ANDA ANDA077022 Physicians Total Care, Inc. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] E 20171231 54868-5412_898c5e2b-1c01-486f-a82e-0345fd3c5575 54868-5412 HUMAN PRESCRIPTION DRUG MIRAPEX pramipexole dihydrochloride TABLET ORAL 20050912 NDA NDA020667 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-5413_5cb043a9-862b-4ba3-8ee3-03f9aa660dee 54868-5413 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE morphine sulfate SOLUTION ORAL 20050912 NDA NDA022195 Physicians Total Care, Inc. MORPHINE SULFATE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5415_f0646bea-d356-441c-8b53-a89245a3762c 54868-5415 HUMAN PRESCRIPTION DRUG Cenestin synthetic conjugated estrogens, A TABLET, FILM COATED ORAL 20050913 NDA NDA020992 Physicians Total Care, Inc. ESTROGENS, CONJUGATED SYNTHETIC A .45 mg/1 E 20171231 54868-5416_4062960e-f215-4ffd-a79e-241c34a67746 54868-5416 HUMAN PRESCRIPTION DRUG EPIVIR lamivudine TABLET, FILM COATED ORAL 20070928 NDA NDA020564 Physicians Total Care, Inc. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 54868-5417_de4c4a2a-bfa3-4149-a524-e90623c34ce1 54868-5417 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20060807 ANDA ANDA020872 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 54868-5418_e8331ace-719a-4405-97f1-fb137e7c2444 54868-5418 HUMAN PRESCRIPTION DRUG Micardis HCT TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET ORAL 20050920 NDA NDA021162 Physicians Total Care, Inc. TELMISARTAN; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5419_b9fe23f0-ce84-42d7-99a8-3a246ead86d5 54868-5419 HUMAN PRESCRIPTION DRUG Allegra--D 24 Hour fexofenadine hydrochloride and pseudoephedrine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050914 NDA NDA021704 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CV E 20171231 54868-5420_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5420 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20050914 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5421_c5337d48-36f3-47ec-bd06-f7f7c8b65c0c 54868-5421 HUMAN PRESCRIPTION DRUG OLUX clobetasol propionate AEROSOL, FOAM TOPICAL 20050915 NDA NDA021142 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5424_7a3f76ec-3c2f-4a29-92a0-68cd8e1ce066 54868-5424 HUMAN PRESCRIPTION DRUG LUXIQ betamethasone valerate AEROSOL, FOAM TOPICAL 20050921 NDA NDA020934 Physicians Total Care, Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5426_88b5ba9c-16df-404f-8453-a38940e2b710 54868-5426 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20091124 NDA NDA021774 Physicians Total Care, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 54868-5430_9cd64ccb-3e5a-43b1-a080-3abc86f9b4e8 54868-5430 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20051005 ANDA ANDA065136 Physicians Total Care, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-5432_001a1b71-7868-44a2-9e28-6935cb4a9718 54868-5432 HUMAN PRESCRIPTION DRUG Carbatrol carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20091015 NDA NDA020712 Physicians Total Care, Inc. CARBAMAZEPINE 300 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 54868-5434_7052259b-d0e1-4b0e-8af6-28dfcb16c893 54868-5434 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride mefloquine hydrochloride TABLET ORAL 20050926 ANDA ANDA076175 Physicians Total Care, Inc. MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] E 20171231 54868-5435_190ac700-81ee-4cba-b80c-a686bae27178 54868-5435 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20060101 ANDA ANDA076577 Physicians Total Care, Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 54868-5436_f1dcf381-23f1-4eb4-897b-dede1cae786f 54868-5436 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride Pilocarpine Hydrochloride TABLET, FILM COATED ORAL 20110721 ANDA ANDA077220 Physicians Total Care, Inc. PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] E 20171231 54868-5437_09dfcc1a-9623-4473-8471-0865f3a46f86 54868-5437 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 20081015 ANDA ANDA075219 Physicians Total Care, Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-5438_65da42c7-85b3-4973-8dbe-99a26de7b227 54868-5438 HUMAN PRESCRIPTION DRUG Mephyton phytonadione TABLET ORAL 20060321 NDA NDA010104 Physicians Total Care, Inc. PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] E 20171231 54868-5439_9bd52b97-5d46-4329-849f-7a49ebdbb8c7 54868-5439 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20060929 NDA NDA021476 Physicians Total Care, Inc. ESZOPICLONE 1 mg/1 CIV E 20171231 54868-5440_cf63553d-cb67-44c0-8c5f-44683f9a30ac 54868-5440 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20051006 NDA NDA020164 Physicians Total Care, Inc. ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 54868-5442_ca6a9e8a-2cba-4775-8131-cb8d8db28ea8 54868-5442 HUMAN PRESCRIPTION DRUG ProAmatine midodrine hydrochloride TABLET ORAL 20050930 NDA NDA019815 Physicians Total Care, Inc. MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 54868-5443_e34908ed-0298-4597-812e-7108d8a56d98 54868-5443 HUMAN PRESCRIPTION DRUG Anagrelide Hydrochloride Anagrelide Hydrochloride CAPSULE ORAL 20070719 ANDA ANDA076468 Physicians Total Care, Inc. ANAGRELIDE HYDROCHLORIDE .5 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] E 20171231 54868-5446_fd513374-c466-41fa-bd54-7017a52cd95a 54868-5446 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate fludrocortisone acetate TABLET ORAL 20051006 ANDA ANDA040431 Physicians Total Care, Inc. FLUDROCORTISONE ACETATE .1 mg/1 E 20171231 54868-5447_fb809355-146a-4baf-a029-a80b7faee7bb 54868-5447 HUMAN PRESCRIPTION DRUG Tarceva erlotinib hydrochloride TABLET ORAL 20051013 NDA NDA021743 Physicians Total Care, Inc. ERLOTINIB HYDROCHLORIDE 150 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] E 20171231 54868-5448_9c8577a5-8492-49be-b6d9-c657beb86a90 54868-5448 HUMAN PRESCRIPTION DRUG MIRTAZAPINE Mirtazapine TABLET ORAL 20051007 ANDA ANDA076122 Physicians Total Care, Inc. MIRTAZAPINE 30 mg/1 E 20171231 54868-5455_85023684-7a16-4f9c-8fca-fe08e0618814 54868-5455 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20060330 ANDA ANDA078541 Physicians Total Care, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5456_cc07c7d6-d6d4-473a-8e5f-e64d1f1ae362 54868-5456 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20051019 NDA NDA021446 Physicians Total Care, Inc. PREGABALIN 150 mg/1 CV E 20171231 54868-5457_b2688fe1-f2f1-4c67-8420-0647a0ff0694 54868-5457 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051020 ANDA ANDA076802 Physicians Total Care, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-5458_986b35e3-4bc7-47af-923e-a7e1f34fac01 54868-5458 HUMAN PRESCRIPTION DRUG Fluticasone Propionate fluticasone propionate OINTMENT TOPICAL 20051020 ANDA ANDA076668 Physicians Total Care, Inc. FLUTICASONE PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5459_e028add7-0ff7-409f-8e66-cb9e8986d403 54868-5459 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20051020 NDA NDA020837 Physicians Total Care, Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-5461_88b5ba9c-16df-404f-8453-a38940e2b710 54868-5461 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20051007 NDA NDA021774 Physicians Total Care, Inc. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 54868-5463_abf93477-f551-4e30-ba94-b2981a9d90cd 54868-5463 HUMAN PRESCRIPTION DRUG Clotrimazole clotrimazole LOZENGE ORAL 20090723 ANDA ANDA076763 Physicians Total Care, Inc. CLOTRIMAZOLE 10 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] E 20171231 54868-5464_853a6948-6069-4b70-993c-b7ce40b9eafd 54868-5464 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE PELLETS ORAL 20071213 ANDA ANDA077167 Physicians Total Care, Inc. DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 54868-5465_4fe6e815-1d03-40df-ad3d-4d12de9648dc 54868-5465 HUMAN PRESCRIPTION DRUG Avalide irbesartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20051101 NDA NDA020758 Physicians Total Care, Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5467_723ef500-4b12-4d0d-b926-ae59e21fe0e0 54868-5467 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051114 ANDA ANDA077270 Physicians Total Care, Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-5468_de4c4a2a-bfa3-4149-a524-e90623c34ce1 54868-5468 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20051109 ANDA ANDA020872 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE 30 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 54868-5469_618032df-c98a-47c7-a522-a42f5bd3e1d2 54868-5469 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20051115 ANDA ANDA090228 Physicians Total Care, Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5471_db900408-b413-4795-9749-e75a8a53d1c5 54868-5471 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065211 Physicians Total Care, Inc. AZITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-5472_03e2ff00-c8ab-43dc-94af-4705dde13a8c 54868-5472 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20080420 ANDA ANDA065390 Physicians Total Care, Inc. RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 54868-5474_fb809355-146a-4baf-a029-a80b7faee7bb 54868-5474 HUMAN PRESCRIPTION DRUG Tarceva erlotinib hydrochloride TABLET ORAL 20051121 NDA NDA021743 Physicians Total Care, Inc. ERLOTINIB HYDROCHLORIDE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] E 20171231 54868-5475_8e359d73-d777-49d9-af50-724344f1a879 54868-5475 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 20080101 ANDA ANDA078211 Physicians Total Care, Inc. QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5477_54642793-18db-4fca-9056-a2ca5a740e59 54868-5477 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM Levothyroxine Sodium TABLET ORAL 20051121 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-5478_db900408-b413-4795-9749-e75a8a53d1c5 54868-5478 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051123 ANDA ANDA065211 Physicians Total Care, Inc. AZITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-5479_9fc8399c-25aa-492f-bc7b-596cbae4d39c 54868-5479 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20051130 ANDA ANDA076137 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5480_758dea45-6f23-49fd-80a0-d4cc884202df 54868-5480 HUMAN PRESCRIPTION DRUG FOSAMAX PLUS D alendronate sodium and cholecalciferol TABLET ORAL 20051130 NDA NDA021762 Physicians Total Care, Inc. ALENDRONATE SODIUM; CHOLECALCIFEROL 70; 2800 mg/1; [iU]/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] E 20171231 54868-5482_98ac152f-ad1c-4f80-b3a3-b122c3702057 54868-5482 HUMAN PRESCRIPTION DRUG Halobetasol Propionate halobetasol propionate OINTMENT TOPICAL 20051205 ANDA ANDA076872 Physicians Total Care, Inc. HALOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5484_a8e03fcb-e9fd-40e2-8516-febf36072b05 54868-5484 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20111118 NDA NDA020639 Physicians Total Care, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-5487_db900408-b413-4795-9749-e75a8a53d1c5 54868-5487 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20070810 ANDA ANDA065212 Physicians Total Care, Inc. AZITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-5494_cc07c7d6-d6d4-473a-8e5f-e64d1f1ae362 54868-5494 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20051220 NDA NDA021446 Physicians Total Care, Inc. PREGABALIN 50 mg/1 CV E 20171231 54868-5499_5855b6df-3949-4d36-b210-0fa2e5db974d 54868-5499 HUMAN PRESCRIPTION DRUG Fortical calcitonin salmon SPRAY, METERED NASAL 20051230 NDA NDA021406 Physicians Total Care, Inc. CALCITONIN SALMON 2200 [iU]/mL Calcitonin [Chemical/Ingredient],Calcitonin [EPC] E 20171231 54868-5500_76dbc4d8-b42f-49ec-b0b6-d19b74ffb051 54868-5500 HUMAN PRESCRIPTION DRUG Actoplus Met pioglitazone hydrochloride and metformin hydrochloride TABLET, FILM COATED ORAL 20060104 NDA NDA021842 Physicians Total Care, Inc. PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 500 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-5501_b9d65d39-a065-4ce1-8c67-df4139d291bf 54868-5501 HUMAN PRESCRIPTION DRUG ARIXTRA fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20041117 NDA NDA021345 Physicians Total Care, Inc. FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] E 20171231 54868-5503_13b193d2-e076-491d-b20c-c5c8d7d8a47c 54868-5503 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060110 ANDA ANDA076486 Physicians Total Care, Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5 g/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5505_6cf43b6a-adb3-4151-8212-3fecde2f14f3 54868-5505 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-5510_fbf1ab44-6114-49ef-9223-4fd6bcf832eb 54868-5510 HUMAN PRESCRIPTION DRUG Clobex clobetasol propionate SPRAY TOPICAL 20060123 NDA NDA021835 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5511_e088942f-17c9-4598-8153-0366f361bfd1 54868-5511 HUMAN PRESCRIPTION DRUG AtroventHFA ipratropium bromide AEROSOL, METERED RESPIRATORY (INHALATION) 20060120 NDA NDA021527 Physicians Total Care, Inc. IPRATROPIUM BROMIDE 17 ug/1 E 20171231 54868-5522_db323395-0dbc-47bd-bc21-85b754faa472 54868-5522 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20060210 ANDA ANDA065040 Physicians Total Care, Inc. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-5523_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5523 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20090415 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5524_ba80da42-fe66-4664-b91b-3ad6f83ad3b2 54868-5524 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE metoprolol tartrate and hydrochlorothiazide TABLET ORAL 20060207 ANDA ANDA076792 Physicians Total Care, Inc. METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5525_79aec30f-078c-407a-b179-fa5d3e9098d2 54868-5525 HUMAN PRESCRIPTION DRUG Depakote divalproex sodium TABLET, EXTENDED RELEASE ORAL 20060210 NDA NDA021168 Physicians Total Care, Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 54868-5526_154afefc-0884-4dd2-98f4-a7f8f4d7e203 54868-5526 HUMAN PRESCRIPTION DRUG Cholestyramine cholestyramine POWDER, FOR SUSPENSION ORAL 20060208 ANDA ANDA077203 Physicians Total Care, Inc. CHOLESTYRAMINE 4 g/5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] E 20171231 54868-5527_496c5df0-d2c8-4bd8-8eb3-7293863db328 54868-5527 HUMAN PRESCRIPTION DRUG Axert almotriptan malate TABLET, COATED ORAL 20060209 NDA NDA021001 Physicians Total Care, Inc. ALMOTRIPTAN MALATE 12.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 54868-5528_b983e8ee-810a-4435-b63f-64512ca2e540 54868-5528 HUMAN PRESCRIPTION DRUG Relpax eletriptan hydrobromide TABLET, FILM COATED ORAL 20071119 NDA NDA021016 Physicians Total Care, Inc. ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 54868-5533_2fad5b6f-85fa-4c52-a08e-6812b98294f0 54868-5533 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080115 ANDA ANDA065230 Physicians Total Care, Inc. CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-5534_c4b582ba-6407-47f8-a96a-eeb47c7f4d12 54868-5534 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20070712 ANDA ANDA040684 Physicians Total Care, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 54868-5538_7f1345f7-1271-4312-b33e-9ba15b3d6f77 54868-5538 HUMAN PRESCRIPTION DRUG Estring estradiol RING VAGINAL 20060227 NDA NDA020472 Physicians Total Care, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-5545_ab08844e-a200-402a-9414-65d592a23eeb 54868-5545 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20060308 ANDA ANDA076504 Physicians Total Care, Inc. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5547_19adf6fb-8fe1-432e-943f-72fa9524cc20 54868-5547 HUMAN PRESCRIPTION DRUG Asmanex Mometasone Furoate INHALANT RESPIRATORY (INHALATION) 20060309 NDA NDA021067 Physicians Total Care, Inc. MOMETASONE FUROATE 220 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5548_3f280d6c-7cf4-47c4-8b1f-3a6218a7cf84 54868-5548 HUMAN PRESCRIPTION DRUG Tarka Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090101 NDA NDA020591 Physicians Total Care, Inc. TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 180 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-5549_fc7059c3-f7ca-44e6-97d3-032fa8154037 54868-5549 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20060314 ANDA ANDA075366 Physicians Total Care, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] E 20171231 54868-5550_cc07c7d6-d6d4-473a-8e5f-e64d1f1ae362 54868-5550 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20061101 NDA NDA021446 Physicians Total Care, Inc. PREGABALIN 75 mg/1 CV E 20171231 54868-5551_967fdce1-748b-4ebf-a954-285fd1e629b5 54868-5551 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20060316 ANDA ANDA076404 Physicians Total Care, Inc. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] E 20171231 54868-5553_76dbc4d8-b42f-49ec-b0b6-d19b74ffb051 54868-5553 HUMAN PRESCRIPTION DRUG Actoplus Met pioglitazone hydrochloride and metformin hydrochloride TABLET, FILM COATED ORAL 20060321 NDA NDA021842 Physicians Total Care, Inc. PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 850 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-5558_e150632a-d379-4a7a-9fd9-b4cb34fa3179 54868-5558 HUMAN PRESCRIPTION DRUG Fortamet metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20060324 NDA NDA021574 Physicians Total Care, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-5564_94674abb-9b63-4684-8e32-567c07e13cbb 54868-5564 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20060330 ANDA ANDA078955 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-5565_872a2746-4e6f-4773-bdbf-ad94f2bc4563 54868-5565 HUMAN PRESCRIPTION DRUG Atrovent ipratropium bromide SPRAY, METERED NASAL 20060331 NDA NDA020393 Physicians Total Care, Inc. IPRATROPIUM BROMIDE 21 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 54868-5566_7be35561-8a33-4a3e-a126-c1dd7239fbd4 54868-5566 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20060411 NDA NDA021906 Physicians Total Care, Inc. LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA] E 20171231 54868-5567_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5567 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20091130 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5570_f1ca50f6-37f5-4e14-a2ea-4d1daaf67ec4 54868-5570 HUMAN PRESCRIPTION DRUG Climara Pro Estradiol and Levonorgestrel PATCH TRANSDERMAL 20060413 NDA NDA021258 Physicians Total Care, Inc. ESTRADIOL; LEVONORGESTREL 4.4; 1.39 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] E 20171231 54868-5572_35ce8e47-1109-411e-86a0-e9efe0eb589e 54868-5572 HUMAN PRESCRIPTION DRUG MEGACE ES megesterol acetate SUSPENSION ORAL 20060413 NDA NDA021778 Physicians Total Care, Inc. MEGESTROL ACETATE 125 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-5574_a3258584-041c-4671-b77c-096eefb3e421 54868-5574 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20060419 ANDA ANDA074918 Physicians Total Care, Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] E 20171231 54868-5575_df3a79de-c4f4-485e-bb53-082e9ccb818d 54868-5575 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20060601 ANDA ANDA075868 Physicians Total Care, Inc. FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 54868-5576_28a99cae-b12b-4528-b922-bfee7c5e2dfa 54868-5576 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20070125 ANDA ANDA076056 Physicians Total Care, Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5577_28a99cae-b12b-4528-b922-bfee7c5e2dfa 54868-5577 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20060511 ANDA ANDA076056 Physicians Total Care, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5578_28a99cae-b12b-4528-b922-bfee7c5e2dfa 54868-5578 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20060511 ANDA ANDA076056 Physicians Total Care, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5579_28a99cae-b12b-4528-b922-bfee7c5e2dfa 54868-5579 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20091211 ANDA ANDA077793 Physicians Total Care, Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5580_700666ac-e66f-46d6-bb1d-62d4dcea8e75 54868-5580 HUMAN OTC DRUG LORATADINE Loratadine SOLUTION ORAL 20060428 ANDA ANDA076805 Physicians Total Care, Inc. LORATADINE 5 mg/5mL E 20171231 54868-5581_a8e03fcb-e9fd-40e2-8516-febf36072b05 54868-5581 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20060428 NDA NDA020639 Physicians Total Care, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-5585_a18a9839-6241-43cd-a50b-22266e7a9589 54868-5585 HUMAN PRESCRIPTION DRUG METROGEL metronidazole GEL TOPICAL 20060728 NDA NDA021789 Physicians Total Care, Inc. METRONIDAZOLE 10 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 54868-5586_87b9641a-07be-4e3d-84a8-a9f2b8c19a77 54868-5586 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20080930 ANDA ANDA076278 Physicians Total Care, Inc. FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] E 20171231 54868-5587_cf63553d-cb67-44c0-8c5f-44683f9a30ac 54868-5587 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20060517 NDA NDA020164 Physicians Total Care, Inc. ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 54868-5589_2fad5b6f-85fa-4c52-a08e-6812b98294f0 54868-5589 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060512 ANDA ANDA065230 Physicians Total Care, Inc. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-5590_c50edaa2-4f73-4ed5-a237-752242c00736 54868-5590 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, EXTENDED RELEASE ORAL 20060517 ANDA ANDA075295 Physicians Total Care, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5597_b34b187e-d110-48df-9687-c255eec7910f 54868-5597 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20060501 ANDA ANDA071611 Physicians Total Care, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 54868-5600_458d20ef-7350-4cee-8a64-d59d9d8b1084 54868-5600 HUMAN PRESCRIPTION DRUG EPZICOM abacavir sulfate and lamivudine TABLET, FILM COATED ORAL 20060522 NDA NDA021652 Physicians Total Care, Inc. ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 54868-5602_983a15fb-e0d8-4e75-aa92-ade42e5e625a 54868-5602 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate SOLUTION NASAL 20060522 ANDA ANDA074830 Physicians Total Care, Inc. DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] E 20171231 54868-5604_2a0dd457-4727-47ff-9268-e9e1b9d17b30 54868-5604 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20060621 NDA NDA020475 Physicians Total Care, Inc. TRETINOIN .4 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-5607_745ce298-abcb-4d11-8c0e-79776cdc6e2e 54868-5607 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20081204 NDA NDA020818 Physicians Total Care, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5611_4d0d7e92-f5a0-4018-9dbd-add04c9fb609 54868-5611 HUMAN PRESCRIPTION DRUG Zegerid omeprazole, sodium bicarbonate CAPSULE ORAL 20060608 NDA NDA021849 Physicians Total Care, Inc. OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-5614_fc7059c3-f7ca-44e6-97d3-032fa8154037 54868-5614 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20090408 ANDA ANDA075366 Physicians Total Care, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] E 20171231 54868-5616_da3f3b40-907e-4111-a726-366b8dcfc997 54868-5616 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20100302 NDA NDA021688 Physicians Total Care, Inc. CINACALCET HYDROCHLORIDE 30 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] E 20171231 54868-5617_031259f7-58e2-4bb8-bcc1-a582bde4ee9a 54868-5617 HUMAN PRESCRIPTION DRUG Erythromycin-Benzoyl Peroxide Erythromycin-Benzoyl Peroxide GEL TOPICAL 20080331 ANDA ANDA050557 Physicians Total Care, Inc. ERYTHROMYCIN; BENZOYL PEROXIDE 30; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-5620_573b81a1-0a14-49d6-98a7-bb99be916201 54868-5620 HUMAN OTC DRUG Simethicone Simethicone SOLUTION/ DROPS ORAL 20071030 OTC MONOGRAPH FINAL part332 Physicians Total Care, Inc. DIMETHICONE; SILICON DIOXIDE 63.3; 3.7 mg/mL; mg/mL E 20171231 54868-5621_96fd8eb0-93c6-4d08-ae0d-7b8fe4c44354 54868-5621 HUMAN PRESCRIPTION DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRATORY (INHALATION) 20060629 NDA NDA020929 Physicians Total Care, Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5622_fba49e33-36bd-48c5-8500-fd36b9cacb7c 54868-5622 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride LIQUID ORAL 20060629 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 54868-5623_a325acae-9aca-40b7-92f9-73e7b35a90cd 54868-5623 HUMAN OTC DRUG Ibuprofen Junior Ibuprofen TABLET, CHEWABLE ORAL 20071016 ANDA ANDA076359 Physicians Total Care, Inc. IBUPROFEN 100 mg/1 E 20171231 54868-5624_301ec476-d899-4616-be96-910bcb384d08 54868-5624 HUMAN OTC DRUG Acetaminophen Acetaminophen SUPPOSITORY RECTAL 20060629 NDA NDA018060 Physicians Total Care, Inc. ACETAMINOPHEN 120 mg/1 E 20171231 54868-5625_38049cd9-c84f-40a5-9f6c-b3a07c8170a3 54868-5625 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20060629 OTC MONOGRAPH FINAL part343 Physicians Total Care, Inc. ACETAMINOPHEN 80 mg/1 E 20171231 54868-5627_4896f77d-3d97-4ffa-ad89-e8bd4cf20feb 54868-5627 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20070202 ANDA ANDA076685 Physicians Total Care, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5628_4896f77d-3d97-4ffa-ad89-e8bd4cf20feb 54868-5628 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20080721 ANDA ANDA076685 Physicians Total Care, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5629_4896f77d-3d97-4ffa-ad89-e8bd4cf20feb 54868-5629 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20080708 ANDA ANDA076685 Physicians Total Care, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5630_4896f77d-3d97-4ffa-ad89-e8bd4cf20feb 54868-5630 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20070523 ANDA ANDA076685 Physicians Total Care, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5636_822f9e27-f5bb-49b0-b483-1403be8e8713 54868-5636 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20060630 ANDA ANDA077914 Physicians Total Care, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 54868-5637_e545053a-9ad5-48f1-94c5-8ae86735e581 54868-5637 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20060705 NDA NDA021433 Physicians Total Care, Inc. FLUTICASONE PROPIONATE 220 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5638_fedbbda2-d131-494e-8375-fe4ebec9f87a 54868-5638 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20060912 NDA AUTHORIZED GENERIC NDA019839 Physicians Total Care, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5639_fedbbda2-d131-494e-8375-fe4ebec9f87a 54868-5639 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20060824 NDA AUTHORIZED GENERIC NDA019839 Physicians Total Care, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5642_9c8577a5-8492-49be-b6d9-c657beb86a90 54868-5642 HUMAN PRESCRIPTION DRUG MIRTAZAPINE Mirtazapine TABLET ORAL 20060714 ANDA ANDA076122 Physicians Total Care, Inc. MIRTAZAPINE 15 mg/1 E 20171231 54868-5643_969b3a71-6ed6-4604-a2aa-ab8fe3624bcb 54868-5643 HUMAN PRESCRIPTION DRUG Atripla efavirenz, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20121016 NDA NDA021937 Physicians Total Care, Inc. EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600; 200; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 54868-5644_db4326cd-862d-4710-9b4e-654efeb813cc 54868-5644 HUMAN PRESCRIPTION DRUG Potassium Citrate potassium citrate TABLET, EXTENDED RELEASE ORAL 20060724 ANDA ANDA077440 Physicians Total Care, Inc. POTASSIUM CITRATE 1080 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-5645_ece7a755-6b4e-4cc9-938e-9106829ee4e0 54868-5645 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20060724 ANDA ANDA076419 Physicians Total Care, Inc. KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-5647_51f52100-ae0b-4308-bd2e-fd4e618c8dd4 54868-5647 HUMAN PRESCRIPTION DRUG Azithromycin azithromycin monohydrate POWDER, FOR SUSPENSION ORAL 20060801 ANDA ANDA050710 Physicians Total Care, Inc. AZITHROMYCIN 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-5648_51f52100-ae0b-4308-bd2e-fd4e618c8dd4 54868-5648 HUMAN PRESCRIPTION DRUG Azithromycin azithromycin monohydrate POWDER, FOR SUSPENSION ORAL 20060803 ANDA ANDA050710 Physicians Total Care, Inc. AZITHROMYCIN 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-5649_6fb833cd-9943-41b5-bd26-babf23ac106a 54868-5649 HUMAN PRESCRIPTION DRUG Rozerem ramelteon TABLET, FILM COATED ORAL 20060801 NDA NDA021782 Physicians Total Care, Inc. RAMELTEON 8 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] E 20171231 54868-5650_5944937d-4840-4562-a5ae-30825414ce0b 54868-5650 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060807 ANDA ANDA077927 Physicians Total Care, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-5651_5944937d-4840-4562-a5ae-30825414ce0b 54868-5651 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060807 ANDA ANDA077927 Physicians Total Care, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-5653_0b937ee5-f2c3-48a9-87d2-f0689ff39043 54868-5653 HUMAN PRESCRIPTION DRUG Advicor niacin and lovastatin TABLET, EXTENDED RELEASE ORAL 20060808 NDA NDA021249 Physicians Total Care, Inc. NIACIN; LOVASTATIN 1000; 40 mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5655_f3e68fe5-0af1-483f-be17-bea16fe9f1ba 54868-5655 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole CREAM TOPICAL 20060814 ANDA ANDA076408 Physicians Total Care, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 54868-5656_48bc8c82-3745-4f40-8728-5d0257d9b388 54868-5656 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20080527 ANDA ANDA076557 Physicians Total Care, Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 E 20171231 54868-5657_58b3d93a-2c9f-4997-a5e9-663160d92fe4 54868-5657 HUMAN PRESCRIPTION DRUG Clobex clobetasol propionate LOTION TOPICAL 20060816 NDA NDA021535 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .05 mL/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5658_fedbbda2-d131-494e-8375-fe4ebec9f87a 54868-5658 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20060816 NDA AUTHORIZED GENERIC NDA019839 Physicians Total Care, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5659_87471cb4-c33e-4146-acda-6a792ed2a4ba 54868-5659 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20060818 ANDA ANDA077828 Physicians Total Care, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 54868-5660_80ae2eaf-98af-4ca0-b6f8-d4ceb2c01e2b 54868-5660 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET ORAL 20060823 ANDA ANDA076509 Physicians Total Care, Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 54868-5662_cc07c7d6-d6d4-473a-8e5f-e64d1f1ae362 54868-5662 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20060829 NDA NDA021446 Physicians Total Care, Inc. PREGABALIN 25 mg/1 CV E 20171231 54868-5663_ec9a9d82-9a1c-4334-a4e5-91fda1b140fa 54868-5663 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine hydrochloride CAPSULE ORAL 20071128 ANDA ANDA075658 Physicians Total Care, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5664_c5e1380a-77e4-4ba7-8388-72beb76ac2fd 54868-5664 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate KIT 20060901 NDA NDA021928 Physicians Total Care, Inc. E 20171231 54868-5667_888c6452-91db-433a-a32b-1c094b0fa551 54868-5667 HUMAN PRESCRIPTION DRUG Bromocriptine Mesylate bromocriptine mesylate TABLET ORAL 20060908 ANDA ANDA076962 Physicians Total Care, Inc. BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] E 20171231 54868-5670_4f15e43e-2be6-4f49-bf18-cfe8c8106f17 54868-5670 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine SOLUTION ORAL; RESPIRATORY (INHALATION) 20090629 ANDA ANDA072324 Physicians Total Care, Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] E 20171231 54868-5672_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5672 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20060921 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5673_8bda2b6b-e72d-4955-9fa2-27af10454d34 54868-5673 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20080324 BLA BLA103234 Physicians Total Care, Inc. ERYTHROPOIETIN 20000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] E 20171231 54868-5674_c5e1380a-77e4-4ba7-8388-72beb76ac2fd 54868-5674 HUMAN PRESCRIPTION DRUG Chantix varenicline tartrate TABLET, FILM COATED ORAL 20060901 NDA NDA021928 Physicians Total Care, Inc. VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] E 20171231 54868-5676_4d2f8129-74e5-4e84-8257-827b160a743d 54868-5676 HUMAN PRESCRIPTION DRUG Oracea doxycycline CAPSULE, DELAYED RELEASE PELLETS ORAL 20060929 ANDA ANDA050805 Physicians Total Care, Inc. DOXYCYCLINE 40 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 54868-5680_0bf4274a-5edc-4e6b-9e1e-22c3e4b1d60d 54868-5680 HUMAN PRESCRIPTION DRUG Taclonex calcipotriene and betamethasone dipropionate OINTMENT TOPICAL 20101020 NDA NDA021852 Physicians Total Care, Inc. CALCIPOTRIENE HYDRATE; BETAMETHASONE DIPROPIONATE 50; .5 ug/g; mg/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5681_7b48908f-c899-4e5f-af2f-0ed42a48530a 54868-5681 HUMAN PRESCRIPTION DRUG FocalinXR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20061011 NDA NDA021802 Physicians Total Care, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5682_7b48908f-c899-4e5f-af2f-0ed42a48530a 54868-5682 HUMAN PRESCRIPTION DRUG FocalinXR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20061011 NDA NDA021802 Physicians Total Care, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5683_7b48908f-c899-4e5f-af2f-0ed42a48530a 54868-5683 HUMAN PRESCRIPTION DRUG FocalinXR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20061011 NDA NDA021802 Physicians Total Care, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5684_7b48908f-c899-4e5f-af2f-0ed42a48530a 54868-5684 HUMAN PRESCRIPTION DRUG FocalinXR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20061011 NDA NDA021802 Physicians Total Care, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5687_960b6700-d38f-48db-ac61-3d2d82e97bec 54868-5687 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir SUSPENSION ORAL 20061003 ANDA ANDA077026 Physicians Total Care, Inc. ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 54868-5689_09114222-c1d5-40eb-a1dd-d0072e0ee658 54868-5689 HUMAN PRESCRIPTION DRUG Xopenex HFA levalbuterol tartrate AEROSOL, METERED ORAL 20071001 NDA NDA021730 Physicians Total Care, Inc. LEVALBUTEROL TARTRATE 45 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-5690_8a1277c4-9a11-4cc9-8a6b-aea181d8c75c 54868-5690 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20061010 NDA NDA020364 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-5691_5b56276f-13f7-4f04-9e9f-425574b69c2d 54868-5691 HUMAN PRESCRIPTION DRUG Phoslo Calcium Acetate CAPSULE ORAL 20100301 NDA NDA021160 Physicians Total Care, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 54868-5692_fd2243fb-6150-4324-9466-84634f7f3b17 54868-5692 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate GEL TOPICAL 20061017 ANDA ANDA075276 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE .64 mg/g E 20171231 54868-5693_4c9f5ab5-825e-4937-9d7a-1c7f781fc728 54868-5693 HUMAN PRESCRIPTION DRUG Cefadroxil cefadroxil monohydrate POWDER, FOR SUSPENSION ORAL 20061019 ANDA ANDA065115 Physicians Total Care, Inc. CEFADROXIL 250 mg/5mL E 20171231 54868-5694_4c9f5ab5-825e-4937-9d7a-1c7f781fc728 54868-5694 HUMAN PRESCRIPTION DRUG Cefadroxil cefadroxil monohydrate POWDER, FOR SUSPENSION ORAL 20070516 ANDA ANDA065115 Physicians Total Care, Inc. CEFADROXIL 500 mg/5mL E 20171231 54868-5697_80ae2eaf-98af-4ca0-b6f8-d4ceb2c01e2b 54868-5697 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET ORAL 20061115 ANDA ANDA076509 Physicians Total Care, Inc. FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 54868-5699_af139a54-d863-4c91-9c29-fc6dec361a0c 54868-5699 HUMAN PRESCRIPTION DRUG Caduet amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20061102 NDA NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-5701_e471506d-cd02-4fcc-acbd-bb881d13561a 54868-5701 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20070312 ANDA ANDA040517 Physicians Total Care, Inc. METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5704_931dca5a-f555-459e-8f09-ae71f80b8960 54868-5704 HUMAN PRESCRIPTION DRUG Enablex darifenacin TABLET, EXTENDED RELEASE ORAL 20061106 NDA NDA021513 Physicians Total Care, Inc. DARIFENACIN 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-5707_a4414e19-f9f5-42e3-9a4d-bf261a881f47 54868-5707 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20080707 NDA NDA020733 Physicians Total Care, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII E 20171231 54868-5708_953e45fd-753e-41bb-9295-813476e9b6ed 54868-5708 HUMAN PRESCRIPTION DRUG Clarinex-D 12 Hour desloratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE ORAL 20061129 NDA NDA021313 Physicians Total Care, Inc. DESLORATADINE; PSEUDOEPHEDRINE SULFATE 2.5; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CV E 20171231 54868-5709_1b4f9d70-940c-4e94-acc9-7871532ec575 54868-5709 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20070426 ANDA ANDA076355 Physicians Total Care, Inc. ALBUTEROL SULFATE 1.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-5711_e823e111-98c5-403e-a2e8-9012784e0fab 54868-5711 HUMAN PRESCRIPTION DRUG MIDAZOLAM HYDROCHLORIDE midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20061212 ANDA ANDA075243 Physicians Total Care, Inc. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-5712_eb12bd6a-9815-4687-8ac7-0bb533fe0137 54868-5712 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20061207 ANDA ANDA074686 Physicians Total Care, Inc. GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 54868-5715_f477bd89-5008-49c7-93ac-7ca6d3a14e2f 54868-5715 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION INTRAVENOUS 20061211 ANDA ANDA076589 Physicians Total Care, Inc. FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] E 20171231 54868-5717_ecd0523c-6fef-4437-90af-23719e7aaf40 54868-5717 HUMAN PRESCRIPTION DRUG Dobutamine Dobutamine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20061211 ANDA ANDA074292 Physicians Total Care, Inc. DOBUTAMINE HYDROCHLORIDE 12.5 mg/mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] E 20171231 54868-5722_c883618f-76da-466a-b7b1-26c96e7b4a45 54868-5722 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride amiodarone hydrochloride INJECTION, SOLUTION INTRAVENOUS 20061211 ANDA ANDA076217 Physicians Total Care, Inc. AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 54868-5724_86cf14f4-6d39-4e6d-9ea2-ba4352f3a59d 54868-5724 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061212 ANDA ANDA075151 Physicians Total Care, Inc. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 54868-5725_05fad6bc-4d30-4a82-8a9e-e9d90ba67988 54868-5725 HUMAN PRESCRIPTION DRUG EPINEPHRINE epinephrine INJECTION, SOLUTION INTRACARDIAC; INTRAVENOUS 20061211 NDA NDA020800 Physicians Total Care, Inc. EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 54868-5726_caef8a69-1e3e-4ee2-81e8-d6f5e8ec5f74 54868-5726 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE metoprolol tartrate INJECTION, SOLUTION INTRAVENOUS 20061211 ANDA ANDA076495 Physicians Total Care, Inc. METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-5728_155eb93c-b3dd-48af-bf1a-6ff094cb5d20 54868-5728 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20061212 ANDA ANDA076644 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-5729_8ad0fad9-c989-46e1-9714-522695bc99ca 54868-5729 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080206 ANDA ANDA076969 Physicians Total Care, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-5730_8ad0fad9-c989-46e1-9714-522695bc99ca 54868-5730 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070803 ANDA ANDA076969 Physicians Total Care, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-5731_8ad0fad9-c989-46e1-9714-522695bc99ca 54868-5731 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100105 ANDA ANDA076969 Physicians Total Care, Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-5732_8ad0fad9-c989-46e1-9714-522695bc99ca 54868-5732 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070731 ANDA ANDA076969 Physicians Total Care, Inc. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-5736_5157468f-8f49-4746-a2c2-91a2020537e3 54868-5736 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Extended Release (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20090723 ANDA ANDA077715 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 54868-5738_c985cb6d-5594-4fb2-9718-f736e991792d 54868-5738 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20061229 ANDA ANDA077050 Physicians Total Care, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 54868-5741_e802c8a3-ae8b-41be-a3c4-a8fe44a2fd0a 54868-5741 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20070105 ANDA ANDA076570 Physicians Total Care, Inc. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 54868-5742_155eb93c-b3dd-48af-bf1a-6ff094cb5d20 54868-5742 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070108 ANDA ANDA076702 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-5743_ded983e5-8794-4330-941d-a10de942c5ed 54868-5743 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20100113 ANDA ANDA078293 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-5746_898c5e2b-1c01-486f-a82e-0345fd3c5575 54868-5746 HUMAN PRESCRIPTION DRUG MIRAPEX pramipexole dihydrochloride TABLET ORAL 20070109 NDA NDA020667 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-5749_a37afd6e-cb80-4908-8ed9-cb50eef30c57 54868-5749 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070116 ANDA ANDA078050 Physicians Total Care, Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 54868-5750_a4414e19-f9f5-42e3-9a4d-bf261a881f47 54868-5750 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20070116 NDA NDA020733 Physicians Total Care, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII E 20171231 54868-5751_c0650ef0-3b4f-44aa-83e9-70111fa25ed1 54868-5751 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SPRAY, METERED NASAL 20070124 ANDA ANDA076025 Physicians Total Care, Inc. IPRATROPIUM BROMIDE 21 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 54868-5754_ea19bd36-7cb9-4836-b1f3-a2b6c852906e 54868-5754 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20070202 ANDA ANDA078627 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5755_8fb54677-a6b7-4c9d-88fb-f7abc1ba13e5 54868-5755 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol CAPSULE, EXTENDED RELEASE ORAL 20070205 ANDA ANDA078065 Physicians Total Care, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-5756_f0ec7dd9-476e-4705-a48f-ea90942be3fd 54868-5756 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20070205 ANDA ANDA065276 Physicians Total Care, Inc. CEFPROZIL 500 mg/1 E 20171231 54868-5757_66c7c968-7156-4edb-9094-bb0da3c1bd18 54868-5757 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070205 ANDA ANDA065261 Physicians Total Care, Inc. CEFPROZIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-5759_fa3f43fa-ff9a-49ae-9127-3a141af355d4 54868-5759 HUMAN PRESCRIPTION DRUG SPRYCEL dasatinib TABLET ORAL 20070212 NDA NDA021986 Physicians Total Care, Inc. DASATINIB 70 mg/1 E 20171231 54868-5761_dbf80a69-a5e3-4816-8665-2ddc41d8a953 54868-5761 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070328 ANDA ANDA078552 Physicians Total Care, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 54868-5762_dbf80a69-a5e3-4816-8665-2ddc41d8a953 54868-5762 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070328 ANDA ANDA078552 Physicians Total Care, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 54868-5764_dbf80a69-a5e3-4816-8665-2ddc41d8a953 54868-5764 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070406 ANDA ANDA078552 Physicians Total Care, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 54868-5765_929a6a1f-8668-425d-aec4-15793be80ea7 54868-5765 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20070404 NDA NDA021081 Physicians Total Care, Inc. INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 54868-5767_2ad2ae6f-7822-46d0-9ffc-32a9c273bf17 54868-5767 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070508 ANDA ANDA065434 Physicians Total Care, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-5768_c21f3dae-e96c-49ee-8177-c9dba8ee73ad 54868-5768 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070508 ANDA ANDA065473 Physicians Total Care, Inc. CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-5769_c21f3dae-e96c-49ee-8177-c9dba8ee73ad 54868-5769 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070509 ANDA ANDA065473 Physicians Total Care, Inc. CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 54868-5770_bbdc7912-ae9e-4c73-bbdf-6dd17d0c53f0 54868-5770 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine Hydrochloride SOLUTION ORAL 20071003 ANDA ANDA091078 Physicians Total Care, Inc. RANITIDINE HYDROCHLORIDE 150 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 54868-5771_887b9788-8ac1-4e6e-9b2e-8c0e79dcd023 54868-5771 HUMAN PRESCRIPTION DRUG COREGCR CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070523 NDA NDA022012 Physicians Total Care, Inc. CARVEDILOL PHOSPHATE 80 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 54868-5772_a742bba8-ee3a-4e5b-b670-ea31c4633b3e 54868-5772 HUMAN PRESCRIPTION DRUG Tekturna aliskiren hemifumarate TABLET, FILM COATED ORAL 20070523 NDA NDA021985 Physicians Total Care, Inc. ALISKIREN HEMIFUMARATE 150 mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA] E 20171231 54868-5773_59a95728-34a6-4741-8807-cba7da17e1ab 54868-5773 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090812 ANDA ANDA078332 Physicians Total Care, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 54868-5774_96fd8eb0-93c6-4d08-ae0d-7b8fe4c44354 54868-5774 HUMAN PRESCRIPTION DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRATORY (INHALATION) 20070601 NDA NDA020929 Physicians Total Care, Inc. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5776_87471cb4-c33e-4146-acda-6a792ed2a4ba 54868-5776 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20070608 ANDA ANDA077828 Physicians Total Care, Inc. CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 54868-5777_d1873a74-56e6-4a01-8e4d-875789e5e344 54868-5777 HUMAN PRESCRIPTION DRUG Dobutamine Hydrochloride Dobutamine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20070613 NDA NDA020201 Physicians Total Care, Inc. DOBUTAMINE HYDROCHLORIDE 400 mg/100mL Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC] E 20171231 54868-5780_745ce298-abcb-4d11-8c0e-79776cdc6e2e 54868-5780 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20070615 NDA NDA020818 Physicians Total Care, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5781_992a5cba-0854-4367-b5fe-60cddbb3c348 54868-5781 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20071026 ANDA ANDA078466 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-5782_992a5cba-0854-4367-b5fe-60cddbb3c348 54868-5782 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20070626 ANDA ANDA078466 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-5783_8a1277c4-9a11-4cc9-8a6b-aea181d8c75c 54868-5783 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20070620 NDA NDA020364 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-5787_16c2a7ef-99f3-4b11-a4fd-a90471a7fddf 54868-5787 HUMAN PRESCRIPTION DRUG Captopril and Hydrochlorothiazide Captopril and Hydrochlorothiazide TABLET ORAL 20070712 ANDA ANDA074896 Physicians Total Care, Inc. CAPTOPRIL; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-5788_b5f46d0d-6971-4954-96ca-01bd0faa52eb 54868-5788 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070713 ANDA ANDA086242 Physicians Total Care, Inc. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 54868-5789_afc7725d-445d-42bf-b41c-f4614121710b 54868-5789 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20070711 ANDA ANDA077634 Physicians Total Care, Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-5792_992a5cba-0854-4367-b5fe-60cddbb3c348 54868-5792 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20070628 ANDA ANDA078466 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-5793_992a5cba-0854-4367-b5fe-60cddbb3c348 54868-5793 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100816 ANDA ANDA078466 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-5794_11e46c02-ed18-442d-8281-3c9d49eec7a5 54868-5794 HUMAN PRESCRIPTION DRUG Terbinafine Hydochloride terbinafine hydrochloride TABLET ORAL 20070712 ANDA ANDA078199 Physicians Total Care, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] E 20171231 54868-5795_183fd856-868e-459a-8361-66ca5ac363e3 54868-5795 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20070711 NDA NDA021428 Physicians Total Care, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 54868-5799_91d78653-caeb-4360-a9b0-d31b4aec2f93 54868-5799 HUMAN PRESCRIPTION DRUG Ergocalciferol ergocalciferol CAPSULE ORAL 20070712 ANDA ANDA040833 Physicians Total Care, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] E 20171231 54868-5801_c985cb6d-5594-4fb2-9718-f736e991792d 54868-5801 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070730 ANDA ANDA077050 Physicians Total Care, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 54868-5802_8bda2b6b-e72d-4955-9fa2-27af10454d34 54868-5802 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20070813 BLA BLA103234 Physicians Total Care, Inc. ERYTHROPOIETIN 40000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] E 20171231 54868-5804_99fc81a8-679b-46b6-900f-7207a878f6df 54868-5804 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20070815 NDA NDA021990 Physicians Total Care, Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-5808_2ed9b59c-40be-4140-aa8e-1584dcd09329 54868-5808 HUMAN PRESCRIPTION DRUG DEMEROL MEPERIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20070821 NDA NDA021171 Physicians Total Care, Inc. MEPERIDINE HYDROCHLORIDE 50 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5809_0ba46c78-f90c-4c2b-9712-3a6cae5f0a44 54868-5809 HUMAN PRESCRIPTION DRUG SELZENTRY Maraviroc TABLET, FILM COATED ORAL 20071219 NDA NDA022128 Physicians Total Care, Inc. MARAVIROC 300 mg/1 CCR5 Co-receptor Antagonist [EPC],Chemokine Co-receptor 5 Antagonists [MoA] E 20171231 54868-5812_9c8577a5-8492-49be-b6d9-c657beb86a90 54868-5812 HUMAN PRESCRIPTION DRUG MIRTAZAPINE Mirtazapine TABLET ORAL 20070823 ANDA ANDA076122 Physicians Total Care, Inc. MIRTAZAPINE 45 mg/1 E 20171231 54868-5814_e1db502f-fa92-4a34-9c93-68bdfb38ba85 54868-5814 HUMAN PRESCRIPTION DRUG Androgel Testosterone GEL TRANSDERMAL 20070829 NDA NDA021015 Physicians Total Care, Inc. TESTOSTERONE 10 mg/g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 54868-5816_70282b0a-c6a1-4653-bf8d-89d1ce7a1d67 54868-5816 HUMAN PRESCRIPTION DRUG Lovaza omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20081211 NDA NDA021654 Physicians Total Care, Inc. OMEGA-3-ACID ETHYL ESTERS 1 g/1 E 20171231 54868-5817_59a95728-34a6-4741-8807-cba7da17e1ab 54868-5817 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070917 ANDA ANDA078332 Physicians Total Care, Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 54868-5819_4c00b6f1-aefd-49a6-a0fd-5899be30ba6d 54868-5819 HUMAN OTC DRUG NICOTINE Transdermal System Step 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20070919 NDA NDA020076 Physicians Total Care, Inc. NICOTINE 7 mg/24h E 20171231 54868-5820_7363d401-12e0-4570-9747-1bdec4646d63 54868-5820 HUMAN OTC DRUG NICOTINE Transdermal System Step 2 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20070919 NDA NDA020076 Physicians Total Care, Inc. NICOTINE 14 mg/24h E 20171231 54868-5821_535f1e93-ce29-4921-98ac-f9c8aa99db75 54868-5821 HUMAN OTC DRUG NICOTINE Transdermal System Step 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20070919 NDA NDA020076 Physicians Total Care, Inc. NICOTINE 21 mg/24h E 20171231 54868-5826_d54c3b62-6791-4f4c-b3cb-47e54aef1b1f 54868-5826 HUMAN PRESCRIPTION DRUG TriNessa norgestimate and ethinyl estradiol KIT 20071030 NDA NDA019697 Physicians Total Care, Inc. E 20171231 54868-5827_10e3f643-f415-4646-bb59-60ca369f9bb2 54868-5827 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20080711 NDA NDA021977 Physicians Total Care, Inc. LISDEXAMFETAMINE DIMESYLATE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5828_89be2fdc-f44c-4b37-9200-a0a68039a92c 54868-5828 HUMAN PRESCRIPTION DRUG Yaz Drospirenone and ethinyl estradiol KIT 20071102 NDA NDA021676 Physicians Total Care, Inc. E 20171231 54868-5829_8b3759e9-e20f-433d-acdb-173863e2b2ae 54868-5829 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride TABLET ORAL 20071106 NDA NDA022064 Physicians Total Care, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 54868-5830_f10bdd5f-6af1-4f57-ac08-c5627263ac51 54868-5830 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071114 ANDA ANDA077802 Physicians Total Care, Inc. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-5831_074a2f68-402f-4481-8ba6-c9b2fd3b5890 54868-5831 HUMAN PRESCRIPTION DRUG Precose Acarbose TABLET ORAL 20071119 NDA NDA020482 Physicians Total Care, Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] E 20171231 54868-5833_c7d8df9e-f779-425d-9fca-74e444bcd864 54868-5833 HUMAN PRESCRIPTION DRUG Cleocin clindamycin palmitate hydrochloride GRANULE, FOR SOLUTION ORAL 20071128 ANDA ANDA061772 Physicians Total Care, Inc. CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 54868-5834_3cf776ce-c44d-4a33-ad21-bb128fcde089 54868-5834 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20071128 ANDA ANDA081203 Physicians Total Care, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5835_cf63553d-cb67-44c0-8c5f-44683f9a30ac 54868-5835 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20071129 NDA NDA020164 Physicians Total Care, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 54868-5836_199662a5-c92a-43ca-88ff-38e30bc6c3b9 54868-5836 HUMAN PRESCRIPTION DRUG Humalog Cartridge Insulin lispro INJECTION, SOLUTION SUBCUTANEOUS 20071203 NDA NDA020563 Physicians Total Care, Inc. INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 54868-5837_cf63553d-cb67-44c0-8c5f-44683f9a30ac 54868-5837 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20071204 NDA NDA020164 Physicians Total Care, Inc. ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 54868-5838_e59e8cfa-c250-483e-b545-d37e1b4baf8b 54868-5838 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR SULFATE CAPSULE, GELATIN COATED ORAL 20071204 NDA NDA021567 Physicians Total Care, Inc. ATAZANAVIR SULFATE 300 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 54868-5839_7c89711c-07e8-404e-9946-bdaefdff3df1 54868-5839 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20071204 NDA NDA020823 Physicians Total Care, Inc. RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 54868-5840_9a1183ca-11db-4b18-9ab4-acb2a7f18e44 54868-5840 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20071213 NDA NDA021995 Physicians Total Care, Inc. SITAGLIPTIN PHOSPHATE 100 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] E 20171231 54868-5841_cf206f2d-793d-4301-a75a-ed2b1d90ba4c 54868-5841 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071220 ANDA ANDA078306 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-5842_e57cd5e0-8294-439b-8b64-ea60d10bb4d0 54868-5842 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20090730 ANDA ANDA076549 Physicians Total Care, Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5843_e57cd5e0-8294-439b-8b64-ea60d10bb4d0 54868-5843 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080221 ANDA ANDA076549 Physicians Total Care, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5844_e7392f6d-0179-49a5-b670-fb6f2a9c7db0 54868-5844 HUMAN PRESCRIPTION DRUG PULMICORT FLEXHALER Budesonide AEROSOL, POWDER RESPIRATORY (INHALATION) 20071228 NDA NDA021949 Physicians Total Care, Inc. BUDESONIDE 180 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5845_002a89fc-4239-4cc2-9de4-b6d3614bb993 54868-5845 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20080102 ANDA ANDA077946 Physicians Total Care, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 54868-5846_1598c85f-10aa-4d0c-a631-6ddf886a8a1b 54868-5846 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20080102 ANDA ANDA077056 Physicians Total Care, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 54868-5847_90123dd1-81e6-42b2-ac2e-c5bae2ed20f7 54868-5847 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET ORAL 20080107 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. GUAIFENESIN 200 mg/1 E 20171231 54868-5849_923d0972-3956-4c62-85b2-d75abcdefb2d 54868-5849 HUMAN OTC DRUG Mucinex D Guaifenesin and pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20080107 NDA NDA021585 Physicians Total Care, Inc. GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 E 20171231 54868-5850_8ea73dd1-dfe3-4628-940f-16587e605fcb 54868-5850 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20080116 NDA NDA020616 Physicians Total Care, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5853_558086c7-d31d-4e1d-b40c-83bec73cd5f4 54868-5853 HUMAN OTC DRUG Mucinex DM Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20080123 NDA NDA021620 Physicians Total Care, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 600; 30 mg/1; mg/1 E 20171231 54868-5854_2a0dd457-4727-47ff-9268-e9e1b9d17b30 54868-5854 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20080124 NDA NDA020475 Physicians Total Care, Inc. TRETINOIN 400 mL/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-5855_6ffa08b1-f48a-45b8-95ce-9ed2672c4902 54868-5855 HUMAN OTC DRUG Cetirizine Hydrochloride cetirizine hydrochloride TABLET, FILM COATED ORAL 20080129 ANDA ANDA076677 Physicians Total Care, Inc. CETIRIZINE HYDROCHLORIDE 5 mg/1 E 20171231 54868-5856_e57cd5e0-8294-439b-8b64-ea60d10bb4d0 54868-5856 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080213 ANDA ANDA076549 Physicians Total Care, Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5857_e44e8fd8-fa4f-40e4-b7b6-8b3742e29f61 54868-5857 HUMAN PRESCRIPTION DRUG QVAR beclomethasone dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20080129 NDA NDA020911 Physicians Total Care, Inc. BECLOMETHASONE DIPROPIONATE 40 ug/1 E 20171231 54868-5858_e44e8fd8-fa4f-40e4-b7b6-8b3742e29f61 54868-5858 HUMAN PRESCRIPTION DRUG QVAR beclomethasone dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20080129 NDA NDA020911 Physicians Total Care, Inc. BECLOMETHASONE DIPROPIONATE 80 ug/1 E 20171231 54868-5859_f7504dcb-f6f9-4b13-bc3f-73ca2b5aaeeb 54868-5859 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20080501 ANDA ANDA090182 Physicians Total Care, Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL E 20171231 54868-5860_931ba10d-c87b-4c19-be15-7361176ed1b8 54868-5860 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080207 ANDA ANDA075710 Physicians Total Care, Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 54868-5861_931ba10d-c87b-4c19-be15-7361176ed1b8 54868-5861 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080207 ANDA ANDA075710 Physicians Total Care, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 54868-5862_931ba10d-c87b-4c19-be15-7361176ed1b8 54868-5862 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080211 ANDA ANDA075710 Physicians Total Care, Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 54868-5864_26d15de0-e8b5-4f82-9c43-624f7f510a6a 54868-5864 HUMAN PRESCRIPTION DRUG Intelence etravirine TABLET ORAL 20080221 NDA NDA022187 Physicians Total Care, Inc. ETRAVIRINE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 54868-5865_026db3f4-9b34-4b2a-9f95-07ccce7c5685 54868-5865 HUMAN OTC DRUG Pramoxine Hydrochloride pramoxine hydrochloride AEROSOL, FOAM RECTAL 20080222 OTC MONOGRAPH FINAL part346 Physicians Total Care, Inc. PRAMOXINE HYDROCHLORIDE 150 mg/15g E 20171231 54868-5869_887b9788-8ac1-4e6e-9b2e-8c0e79dcd023 54868-5869 HUMAN PRESCRIPTION DRUG COREGCR CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20080509 NDA NDA022012 Physicians Total Care, Inc. CARVEDILOL PHOSPHATE 40 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 54868-5870_b6744211-555b-4401-9b41-d503e9465ac2 54868-5870 HUMAN OTC DRUG Aquaphor Petrolatum OINTMENT TOPICAL 20080328 OTC MONOGRAPH FINAL part347 Physicians Total Care, Inc. PETROLATUM 41 g/100g E 20171231 54868-5875_c88a4047-8d8c-4ce7-911a-4dcd6cb4baf1 54868-5875 HUMAN OTC DRUG Aveeno Dimethicone LOTION TOPICAL 20080331 OTC MONOGRAPH FINAL part347 Physicians Total Care, Inc. DIMETHICONE 13 mg/g E 20171231 54868-5876_2a573d66-a2c7-4c16-a744-2aea84a730b9 54868-5876 HUMAN OTC DRUG Zeasorb AF miconazole nitrate POWDER TOPICAL 20080331 OTC MONOGRAPH FINAL part333C Physicians Total Care, Inc. MICONAZOLE NITRATE 20.6 mg/g E 20171231 54868-5879_8e580ba8-f7c1-4ba1-9b4b-d6c7a21d12d5 54868-5879 HUMAN OTC DRUG ZYRTEC D Allergy and Congestion Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080328 NDA NDA021150 Physicians Total Care, Inc. CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 E 20171231 54868-5882_030c1db3-fbce-4963-bc60-7438d927c8b4 54868-5882 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole LOTION TOPICAL 20080327 ANDA ANDA077197 Physicians Total Care, Inc. METRONIDAZOLE 7.5 mg/mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 54868-5883_baf2526e-303d-4178-a7e5-82c77e7f8a6f 54868-5883 HUMAN PRESCRIPTION DRUG Levemir insulin detemir INJECTION, SOLUTION SUBCUTANEOUS 20080331 NDA NDA021536 Physicians Total Care, Inc. INSULIN DETEMIR 14.2 mg/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 54868-5884_6f6eac97-fbc3-44a5-a6f4-fba3e559f664 54868-5884 HUMAN OTC DRUG Cetirizine HCl and Pseudoephedrine HCl ER Cetirizine HCl and Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080331 ANDA ANDA077991 Physicians Total Care, Inc. CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 CV E 20171231 54868-5887_a37afd6e-cb80-4908-8ed9-cb50eef30c57 54868-5887 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20080508 ANDA ANDA078050 Physicians Total Care, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 54868-5888_e64419f7-490f-4643-bb8c-7e171c8c8c15 54868-5888 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION INTRAVENOUS 20080508 ANDA ANDA076781 Physicians Total Care, Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 54868-5889_f849b89b-f428-48c3-a779-463e444ec8ce 54868-5889 HUMAN PRESCRIPTION DRUG OsmoPrep SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS TABLET ORAL 20080530 NDA NDA021892 Physicians Total Care, Inc. SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS 1.102; .398 g/1; g/1 Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-5890_ff3c9070-c458-4917-97a8-39c11edddd36 54868-5890 HUMAN PRESCRIPTION DRUG MOVIPREP POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE and ASCORBIC ACID KIT 20080530 NDA NDA021881 Physicians Total Care, Inc. E 20171231 54868-5891_61037334-857a-4ea4-b74c-88898aafa28f 54868-5891 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20080508 ANDA ANDA074286 Physicians Total Care, Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5893_23b070b1-1411-4a78-8b05-136d854c7df2 54868-5893 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone LOTION TOPICAL 20080508 ANDA ANDA089074 Physicians Total Care, Inc. HYDROCORTISONE 25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5896_e57cd5e0-8294-439b-8b64-ea60d10bb4d0 54868-5896 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080714 ANDA ANDA076549 Physicians Total Care, Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5897_af99b509-0cf2-40cb-9198-40414a82ca46 54868-5897 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20080521 ANDA ANDA078230 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-5899_199662a5-c92a-43ca-88ff-38e30bc6c3b9 54868-5899 HUMAN PRESCRIPTION DRUG Humalog Pen Insulin lispro INJECTION, SOLUTION SUBCUTANEOUS 20080512 NDA NDA020563 Physicians Total Care, Inc. INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 54868-5900_375b89df-4150-4279-a973-2eadb132a225 54868-5900 HUMAN PRESCRIPTION DRUG Dihydrocodeine Bitartrate, Acetaminophen and Caffeine Dihydrocodeine Bitartrate, Acetaminophen and Caffeine TABLET ORAL 20080520 ANDA ANDA040701 Physicians Total Care, Inc. DIHYDROCODEINE BITARTRATE; ACETAMINOPHEN; CAFFEINE 32; 712.8; 60 mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII E 20171231 54868-5901_262588dd-98d4-4859-8ea6-032744c9a832 54868-5901 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20081107 ANDA ANDA078428 Physicians Total Care, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-5902_69c62db2-25f0-4f7e-937d-8a52e457ee49 54868-5902 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET ORAL 20080606 ANDA ANDA077290 Physicians Total Care, Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5903_537cd838-05f2-44f4-aeb2-89c42f153e3c 54868-5903 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20080530 ANDA ANDA088316 Physicians Total Care, Inc DEXAMETHASONE 6 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5905_6b06a2a1-91d7-492c-8437-64c4fe5470f2 54868-5905 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20080616 ANDA ANDA077487 Physicians Total Care, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 54868-5908_9a40abe9-6936-4452-8546-f3ed99c2bab6 54868-5908 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080619 ANDA ANDA078829 Physicians Total Care, Inc. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 54868-5909_9a40abe9-6936-4452-8546-f3ed99c2bab6 54868-5909 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080619 ANDA ANDA078829 Physicians Total Care, Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 54868-5911_e4bf8c4e-edd9-4cdb-ae48-48fa35bb4bcf 54868-5911 HUMAN OTC DRUG Omeprazole omeprazole TABLET, DELAYED RELEASE ORAL 20080619 NDA NDA022032 Physicians Total Care, Inc. OMEPRAZOLE 20 mg/1 E 20171231 54868-5912_af99b509-0cf2-40cb-9198-40414a82ca46 54868-5912 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20080627 ANDA ANDA078230 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-5913_6a95d07c-a9d4-4fbc-b1c0-9b323edfb778 54868-5913 HUMAN OTC DRUG Clemastine Fumarate Clemastine Fumarate TABLET ORAL 20080627 ANDA ANDA073458 Physicians Total Care, Inc. CLEMASTINE FUMARATE 1.34 mg/1 E 20171231 54868-5914_af99b509-0cf2-40cb-9198-40414a82ca46 54868-5914 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20080702 ANDA ANDA078230 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-5915_d67caab0-2ebd-4d80-a415-2e329fb5a34e 54868-5915 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 20080708 ANDA ANDA072735 Physicians Total Care, Inc. LEUCOVORIN CALCIUM 15 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 54868-5916_10e3f643-f415-4646-bb59-60ca369f9bb2 54868-5916 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20080711 NDA NDA021977 Physicians Total Care, Inc. LISDEXAMFETAMINE DIMESYLATE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-5918_c031d46a-1f80-4600-ab2e-ff0b6e267e2a 54868-5918 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 20080723 ANDA ANDA079088 Physicians Total Care, Inc RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-5921_803d538c-3eeb-4c67-97a1-40da1861fc84 54868-5921 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20080730 ANDA ANDA076388 Physicians Total Care, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 54868-5922_b6b00292-9230-43f4-8d2b-7aa1f13d734d 54868-5922 HUMAN PRESCRIPTION DRUG OCELLA drospirenone and ethinyl estradiol KIT 20080731 NDA NDA021098 Physicians Total Care, Inc. E 20171231 54868-5926_2a0dd457-4727-47ff-9268-e9e1b9d17b30 54868-5926 HUMAN PRESCRIPTION DRUG Retin-A MICRO Tretinoin GEL TOPICAL 20080808 NDA NDA020475 Physicians Total Care, Inc. TRETINOIN 1 mL/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-5927_5157468f-8f49-4746-a2c2-91a2020537e3 54868-5927 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Extended Release (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20080813 ANDA ANDA077715 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 54868-5928_d3ca750e-3050-4214-aea8-cffa33a2d61a 54868-5928 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET ORAL 20080814 ANDA ANDA078454 Physicians Total Care, Inc. MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-5929_86ad6d8b-e912-4eb3-94b1-6ede128d3e45 54868-5929 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20080819 ANDA ANDA078292 Physicians Total Care, Inc. DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII E 20171231 54868-5930_190ac700-81ee-4cba-b80c-a686bae27178 54868-5930 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20080819 ANDA ANDA076577 Physicians Total Care, Inc. MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 54868-5931_7d69deb0-58a5-4a54-84e5-96caa2fb7003 54868-5931 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080829 ANDA ANDA079051 Physicians Total Care, Inc. NISOLDIPINE 40 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] E 20171231 54868-5932_7aa51422-650b-4436-b57a-ec2e27cf7346 54868-5932 HUMAN PRESCRIPTION DRUG BICILLIN CR penicillin G benzathine and penicillin G procaine INJECTION, SUSPENSION INTRAMUSCULAR 20080828 NDA NDA050138 Physicians Total Care, Inc. PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 600000; 600000 [iU]/2mL; [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 54868-5934_b02b798f-01b7-491e-8802-11057828e6f6 54868-5934 HUMAN PRESCRIPTION DRUG Menest Estrogens, esterified TABLET ORAL 20080905 ANDA ANDA084948 Physicians Total Care, Inc. ESTROGENS, ESTERIFIED .625 mg/1 E 20171231 54868-5935_01fd5716-bb59-49b0-a0ed-8da299cf060f 54868-5935 HUMAN PRESCRIPTION DRUG Junel Fe 1.5/30 norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20080902 ANDA ANDA076064 Physicians Total Care, Inc. E 20171231 54868-5938_88c1b159-4dbc-44f6-adbd-edc267640625 54868-5938 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 20080908 NDA NDA050693 Physicians Total Care, Inc. AZITHROMYCIN DIHYDRATE 1 g/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-5942_62281903-f98d-4903-9a63-b54ba4842b16 54868-5942 HUMAN PRESCRIPTION DRUG Kelnor 1/35 ethynodiol diacetate and ethinyl estradiol KIT 20080916 ANDA ANDA076785 Physicians Total Care, Inc. E 20171231 54868-5944_b9d62f7c-cb41-4b19-b488-a88ff08b1baa 54868-5944 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20081002 NDA NDA021742 Physicians Total Care, Inc. NEBIVOLOL HYDROCHLORIDE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-5945_337c0383-46b3-4f8a-929b-3d650eac3634 54868-5945 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20081003 ANDA ANDA078470 Physicians Total Care, Inc. ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] E 20171231 54868-5950_c92c4adf-6ff2-4eda-a868-b0af18b08ae6 54868-5950 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride TABLET, FILM COATED ORAL 20081009 ANDA ANDA075998 Physicians Total Care, Inc. PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] E 20171231 54868-5951_2c717d2f-6a42-44cd-815f-3efe43cce3c8 54868-5951 HUMAN PRESCRIPTION DRUG Lexapro escitalopram oxalate TABLET ORAL 20091130 NDA NDA021323 Physicians Total Care, Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-5952_af99b509-0cf2-40cb-9198-40414a82ca46 54868-5952 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20081022 ANDA ANDA078230 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-5953_af99b509-0cf2-40cb-9198-40414a82ca46 54868-5953 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20081022 ANDA ANDA078230 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-5954_7cccdc96-0f15-4755-9d18-9d74f55a815c 54868-5954 HUMAN PRESCRIPTION DRUG Exelon rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20081014 NDA NDA022083 Physicians Total Care, Inc. RIVASTIGMINE 9.5 mg/24[USP'U] Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 54868-5955_803d538c-3eeb-4c67-97a1-40da1861fc84 54868-5955 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20081205 ANDA ANDA076388 Physicians Total Care, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 54868-5956_e899df9b-095c-4c16-895f-3307f9810383 54868-5956 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20081023 NDA NDA021368 Physicians Total Care, Inc. TADALAFIL 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 54868-5957_6a8cd103-424c-4edc-ae29-3965f1d5a6bb 54868-5957 HUMAN PRESCRIPTION DRUG TUSSICAPS hydrocodone polistirex and chlorpheniramine polistirex CAPSULE, EXTENDED RELEASE ORAL 20081027 ANDA ANDA077273 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE 10; 8 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII E 20171231 54868-5958_a493f5ce-fdb0-400a-a1f0-fba66755f779 54868-5958 HUMAN PRESCRIPTION DRUG DIFFERIN adapalene GEL TOPICAL 20081024 NDA NDA021753 Physicians Total Care, Inc. ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-5962_3d658b37-9931-4156-871a-e34e36b3dc35 54868-5962 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20081117 ANDA ANDA021234 Physicians Total Care, Inc. DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-5963_0825579e-56f9-4c3a-8c17-3a60abdc225d 54868-5963 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH TRANSDERMAL 20081118 ANDA ANDA076258 Physicians Total Care, Inc. FENTANYL 1.28 mg/[USP'U] Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5964_8ea73dd1-dfe3-4628-940f-16587e605fcb 54868-5964 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20081119 NDA NDA020616 Physicians Total Care, Inc. MORPHINE SULFATE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5965_becbc961-a269-4ca9-97a0-0fabad3241e8 54868-5965 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20081121 NDA NDA022122 Physicians Total Care, Inc. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-5967_11260608-48a3-4881-84d8-f394f1b3b6f6 54868-5967 HUMAN OTC DRUG Eucerin Octinoxate, Zinc Oxide, Octisalate, Ensulizole, Titanium Dioxide LOTION TOPICAL 20081119 OTC MONOGRAPH NOT FINAL part352 Physicians Total Care, Inc. OCTINOXATE; ZINC OXIDE; OCTISALATE; ENSULIZOLE; TITANIUM DIOXIDE 7.5; 4.85; 4.5; 2; 2.38 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 54868-5968_bac29918-a4b8-4dbc-8620-986e9c6265cc 54868-5968 HUMAN PRESCRIPTION DRUG Travatan Z travoprost SOLUTION OPHTHALMIC 20081209 NDA NDA021994 Physicians Total Care, Inc. TRAVOPROST .04 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] E 20171231 54868-5969_04f573ea-41f5-4891-b474-eb19b2e6caa2 54868-5969 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20081209 NDA NDA021976 Physicians Total Care, Inc. DARUNAVIR ETHANOLATE 400 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 54868-5971_f534208b-95b9-449a-83bc-5f6dc33b4ea7 54868-5971 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20081216 NDA NDA021908 Physicians Total Care, Inc. LUBIPROSTONE 24 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] E 20171231 54868-5972_75eebf07-eadb-4b8d-b67c-a5a5780dcfdf 54868-5972 HUMAN PRESCRIPTION DRUG XIFAXAN RIFAXIMIN TABLET ORAL 20081214 NDA NDA021361 Physicians Total Care, Inc. RIFAXIMIN 200 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 54868-5974_b4465a3f-52bf-4b27-a980-dcdf031337be 54868-5974 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20081218 NDA NDA020950 Physicians Total Care, Inc. IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 3 mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-5975_d778c872-757c-4742-842c-58ca85a8a582 54868-5975 HUMAN PRESCRIPTION DRUG Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20081219 NDA NDA020747 Physicians Total Care, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-5977_7c4c1776-6fe6-419a-9eb6-3e365693efa3 54868-5977 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20090102 NDA NDA021283 Physicians Total Care, Inc. VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-5978_0b064801-4d1c-4b88-b6cf-7e13611cb2da 54868-5978 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090120 NDA NDA020132 Physicians Total Care, Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 54868-5979_2674788d-9a0d-4db6-a480-2af6ac2517d4 54868-5979 HUMAN PRESCRIPTION DRUG Nucynta tapentadol hydrochloride TABLET, FILM COATED ORAL 20100319 NDA NDA022304 Physicians Total Care, Inc. TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 54868-5980_cef15d8b-d8c6-491e-9549-695ddc33892b 54868-5980 HUMAN PRESCRIPTION DRUG TEMODAR Temozolomide CAPSULE ORAL 20090126 NDA NDA021029 Physicians Total Care, Inc. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 54868-5982_16811649-e7c8-4e86-b5e6-e0197ef4d642 54868-5982 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20090204 ANDA ANDA077847 Physicians Total Care, Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] E 20171231 54868-5983_99fc81a8-679b-46b6-900f-7207a878f6df 54868-5983 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20090622 NDA NDA021990 Physicians Total Care, Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-5984_287cfe76-1f00-4498-8d38-61828ba88ad5 54868-5984 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 20090212 NDA NDA019614 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-5985_aae1e3d3-0216-4b36-889c-05871ffa3014 54868-5985 HUMAN PRESCRIPTION DRUG Sancuso granisetron PATCH TRANSDERMAL 20090216 NDA NDA022198 Physicians Total Care, Inc. GRANISETRON 3.1 mg/24h Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 54868-5986_b267a9e3-5e2c-4674-9f42-4df71ae69dcc 54868-5986 HUMAN PRESCRIPTION DRUG Trilipix Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20090219 NDA NDA022224 Physicians Total Care, Inc. FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] E 20171231 54868-5987_1e319b95-24f3-4b75-8d58-b96ef68d8651 54868-5987 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090123 ANDA ANDA075410 Physicians Total Care, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-5989_f1be53e3-f694-47b0-9652-f33ae84b1aa1 54868-5989 HUMAN PRESCRIPTION DRUG Alvesco ciclesonide AEROSOL, METERED RESPIRATORY (INHALATION) 20090219 NDA NDA021658 Physicians Total Care, Inc. CICLESONIDE 80 ug/1 E 20171231 54868-5990_f1be53e3-f694-47b0-9652-f33ae84b1aa1 54868-5990 HUMAN PRESCRIPTION DRUG Alvesco ciclesonide AEROSOL, METERED RESPIRATORY (INHALATION) 20090223 NDA NDA021658 Physicians Total Care, Inc. CICLESONIDE 160 ug/1 E 20171231 54868-5991_8a342236-6044-4c69-ae35-48b4e5338fed 54868-5991 HUMAN PRESCRIPTION DRUG EPIDUO adapalene and benzoyl peroxide GEL TOPICAL 20090224 NDA NDA022320 Physicians Total Care, Inc. ADAPALENE; BENZOYL PEROXIDE 1; 25 mg/g; mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-5992_a56cf9f2-99f5-42df-a203-f8245c428ae5 54868-5992 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20090224 ANDA ANDA077511 Physicians Total Care, Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g E 20171231 54868-5993_a92dc909-acb6-476c-8d3c-3730b809e34e 54868-5993 HUMAN PRESCRIPTION DRUG SULAR Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090224 NDA NDA020356 Physicians Total Care, Inc. NISOLDIPINE 25.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] E 20171231 54868-5994_df3a79de-c4f4-485e-bb53-082e9ccb818d 54868-5994 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20090225 ANDA ANDA075868 Physicians Total Care, Inc. FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 54868-5995_e545053a-9ad5-48f1-94c5-8ae86735e581 54868-5995 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20090226 NDA NDA021433 Physicians Total Care, Inc. FLUTICASONE PROPIONATE 44 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-5996_99fc81a8-679b-46b6-900f-7207a878f6df 54868-5996 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20090305 NDA NDA021990 Physicians Total Care, Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-5997_99fc81a8-679b-46b6-900f-7207a878f6df 54868-5997 HUMAN PRESCRIPTION DRUG Exforge amlodipine besylate and valsartan TABLET, FILM COATED ORAL 20090305 NDA NDA021990 Physicians Total Care, Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-5998_1197a605-9f66-43f5-84d9-5d580afd8aa4 54868-5998 HUMAN PRESCRIPTION DRUG Kapidex dexlansoprazole CAPSULE, DELAYED RELEASE ORAL 20090305 NDA NDA022287 Physicians Total Care, Inc. DEXLANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 54868-6002_2674788d-9a0d-4db6-a480-2af6ac2517d4 54868-6002 HUMAN PRESCRIPTION DRUG Nucynta tapentadol hydrochloride TABLET, FILM COATED ORAL 20100319 NDA NDA022304 Physicians Total Care, Inc. TAPENTADOL HYDROCHLORIDE 75 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 54868-6003_d5eac7eb-f3db-4562-a97b-f4f2117d361b 54868-6003 HUMAN OTC DRUG Delsym Dextromethorphan SUSPENSION, EXTENDED RELEASE ORAL 20090313 NDA NDA018658 Physicians Total Care, Inc. DEXTROMETHORPHAN 30 mg/5mL E 20171231 54868-6009_10e3f643-f415-4646-bb59-60ca369f9bb2 54868-6009 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20090320 NDA NDA021977 Physicians Total Care, Inc. LISDEXAMFETAMINE DIMESYLATE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-6010_231bd619-d4f8-4efd-b887-6be6191867b2 54868-6010 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam SOLUTION, CONCENTRATE ORAL 20090331 ANDA ANDA073079 Physicians Total Care, Inc. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-6014_18c9e286-5734-4554-8201-b80a459d5551 54868-6014 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090508 ANDA ANDA090278 Physicians Total Care, Inc TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-6015_18c9e286-5734-4554-8201-b80a459d5551 54868-6015 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20100322 ANDA ANDA090278 Physicians Total Care, Inc TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-6016_18c9e286-5734-4554-8201-b80a459d5551 54868-6016 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090413 ANDA ANDA090278 Physicians Total Care, Inc TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-6017_18c9e286-5734-4554-8201-b80a459d5551 54868-6017 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090506 ANDA ANDA090278 Physicians Total Care, Inc TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-6018_b9d62f7c-cb41-4b19-b488-a88ff08b1baa 54868-6018 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20090415 NDA NDA021742 Physicians Total Care, Inc. NEBIVOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 54868-6019_887b9788-8ac1-4e6e-9b2e-8c0e79dcd023 54868-6019 HUMAN PRESCRIPTION DRUG COREGCR CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20090415 NDA NDA022012 Physicians Total Care, Inc. CARVEDILOL PHOSPHATE 10 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 54868-6020_1aa90504-faab-4eb0-9e29-058b6cac81d5 54868-6020 HUMAN PRESCRIPTION DRUG Omnaris ciclesonide SPRAY NASAL 20090415 NDA NDA022004 Physicians Total Care, Inc. CICLESONIDE 50 ug/1 E 20171231 54868-6021_e028add7-0ff7-409f-8e66-cb9e8986d403 54868-6021 HUMAN PRESCRIPTION DRUG Xopenex levalbuterol hydrochloride SOLUTION, CONCENTRATE RESPIRATORY (INHALATION) 20090421 NDA NDA020837 Physicians Total Care, Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-6022_902dee94-2e89-4ada-96b2-36cc4d1eb34f 54868-6022 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090416 NDA NDA021777 Physicians Total Care, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 54868-6023_0b064801-4d1c-4b88-b6cf-7e13611cb2da 54868-6023 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090416 NDA NDA020132 Physicians Total Care, Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 54868-6024_a5dceee5-5fd9-40e9-824b-022c91017b63 54868-6024 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20100119 NDA NDA022256 Physicians Total Care, Inc. MILNACIPRAN HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-6025_d778c872-757c-4742-842c-58ca85a8a582 54868-6025 HUMAN PRESCRIPTION DRUG Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20090424 NDA NDA020747 Physicians Total Care, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-6026_d778c872-757c-4742-842c-58ca85a8a582 54868-6026 HUMAN PRESCRIPTION DRUG Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20090424 NDA NDA020747 Physicians Total Care, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-6027_d778c872-757c-4742-842c-58ca85a8a582 54868-6027 HUMAN PRESCRIPTION DRUG Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20090424 NDA NDA020747 Physicians Total Care, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-6028_6aec4d10-3bac-4afb-bb7f-6a0e23556143 54868-6028 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090504 NDA AUTHORIZED GENERIC NDA021303 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-6029_6aec4d10-3bac-4afb-bb7f-6a0e23556143 54868-6029 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090504 NDA AUTHORIZED GENERIC NDA021303 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-6030_bd4c55cb-e75c-4afb-ab21-ea62789e88c9 54868-6030 HUMAN PRESCRIPTION DRUG Femring estradiol acetate RING VAGINAL 20090504 NDA NDA021367 Physicians Total Care, Inc. ESTRADIOL ACETATE .1 mg/24[USP'U] Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-6031_9a1183ca-11db-4b18-9ab4-acb2a7f18e44 54868-6031 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20090506 NDA NDA021995 Physicians Total Care, Inc. SITAGLIPTIN PHOSPHATE 50 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] E 20171231 54868-6033_6aec4d10-3bac-4afb-bb7f-6a0e23556143 54868-6033 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090519 NDA AUTHORIZED GENERIC NDA021303 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-6034_6aec4d10-3bac-4afb-bb7f-6a0e23556143 54868-6034 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20090519 NDA AUTHORIZED GENERIC NDA021303 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-6035_de09314a-e8c5-4578-937c-307cc649fe84 54868-6035 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS AURICULAR (OTIC) 20090521 ANDA ANDA076616 Physicians Total Care, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-6036_94cc0af7-0516-4ef0-8bfe-39f2708ef22e 54868-6036 HUMAN PRESCRIPTION DRUG Azor amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20090602 NDA NDA022100 Physicians Total Care, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-6037_d778c872-757c-4742-842c-58ca85a8a582 54868-6037 HUMAN PRESCRIPTION DRUG Fentanyl Citrate fentanyl citrate LOZENGE ORAL; TRANSMUCOSAL 20090605 NDA NDA020747 Physicians Total Care, Inc. FENTANYL CITRATE 1200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-6038_1598c85f-10aa-4d0c-a631-6ddf886a8a1b 54868-6038 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20090603 ANDA ANDA077056 Physicians Total Care, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 54868-6039_2674788d-9a0d-4db6-a480-2af6ac2517d4 54868-6039 HUMAN PRESCRIPTION DRUG Nucynta tapentadol hydrochloride TABLET, FILM COATED ORAL 20100319 NDA NDA022304 Physicians Total Care, Inc. TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 54868-6041_3a41bc46-8bba-4c61-9299-3108f05a0d4d 54868-6041 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20090615 NDA NDA022107 Physicians Total Care, Inc. ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-6042_a742bba8-ee3a-4e5b-b670-ea31c4633b3e 54868-6042 HUMAN PRESCRIPTION DRUG Tekturna aliskiren hemifumarate TABLET, FILM COATED ORAL 20090622 NDA NDA021985 Physicians Total Care, Inc. ALISKIREN HEMIFUMARATE 300 mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA] E 20171231 54868-6043_a5dceee5-5fd9-40e9-824b-022c91017b63 54868-6043 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090622 NDA NDA022256 Physicians Total Care, Inc. MILNACIPRAN HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-6044_edb90de8-4b9c-4e69-b3a2-1bb5eaaff306 54868-6044 HUMAN PRESCRIPTION DRUG Jolessa levonorgestrel and ethinyl estradiol KIT 20090624 NDA NDA021544 Physicians Total Care, Inc. E 20171231 54868-6045_c460a458-ee62-417c-8e9e-6ce3045b5c40 54868-6045 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20090625 NDA AUTHORIZED GENERIC NDA021134 Physicians Total Care, Inc. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 54868-6048_3a76a4d0-bd0f-409e-adf0-0cbaae53243c 54868-6048 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20090626 ANDA ANDA079234 Physicians Total Care, Inc. TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 54868-6049_ad1d2297-0516-4581-88af-55f28485fe52 54868-6049 HUMAN PRESCRIPTION DRUG PATANASE olopatadine hydrochloride SPRAY, METERED NASAL 20090713 NDA NDA021861 Physicians Total Care, Inc. OLOPATADINE HYDROCHLORIDE 665 ug/1 Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] E 20171231 54868-6050_be9dfccb-7666-4f44-be3a-32e6acc42ad7 54868-6050 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20091111 NDA NDA020983 Physicians Total Care, Inc. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-6051_00c1c38b-a6b9-42bd-ab6d-f2e08ac3893f 54868-6051 HUMAN PRESCRIPTION DRUG Proventil HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20090717 NDA NDA020503 Physicians Total Care, Inc. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 54868-6052_2eb12bd4-ecd4-4917-bb54-bf42702dc6f3 54868-6052 HUMAN PRESCRIPTION DRUG SUMATRIPTAN sumatriptan SPRAY NASAL 20090723 NDA NDA020626 Physicians Total Care, Inc. SUMATRIPTAN 20 mg/100uL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 54868-6056_b54e3b4b-baaf-4df7-a425-21d8caa45b83 54868-6056 HUMAN PRESCRIPTION DRUG Divigel estradiol GEL TOPICAL 20090804 NDA NDA022038 Physicians Total Care, Inc. ESTRADIOL 1 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-6057_0102df63-59b3-4493-ba5b-1ecd914dbc91 54868-6057 HUMAN PRESCRIPTION DRUG Dovonex Calcipotriene SOLUTION TOPICAL 20090812 NDA NDA020611 Physicians Total Care, Inc. CALCIPOTRIENE .05 mg/mL Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] E 20171231 54868-6061_02953299-f03e-4305-9b78-8590f2ad4a46 54868-6061 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20090826 ANDA ANDA077256 Physicians Total Care, Inc. TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 54868-6062_61d8c50d-47a7-409d-a3bb-b74d2a745487 54868-6062 HUMAN PRESCRIPTION DRUG BENZACLIN clindamycin phosphate and benzoyl peroxide GEL TOPICAL 20090827 NDA NDA050756 Physicians Total Care, Inc. CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE 10; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 54868-6064_5697e989-d676-4d13-81dc-b7ffe7be4f1f 54868-6064 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20090904 ANDA ANDA078079 Physicians Total Care, Inc. CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] E 20171231 54868-6065_3bbca54f-08ae-4ef7-8a8c-75a204f4df8a 54868-6065 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20090914 ANDA ANDA078510 Physicians Total Care, Inc. EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 54868-6066_4896f77d-3d97-4ffa-ad89-e8bd4cf20feb 54868-6066 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET ORAL 20090924 ANDA ANDA076685 Physicians Total Care, Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-6067_1adb5942-7330-48c9-add5-a0b321ce860b 54868-6067 HUMAN PRESCRIPTION DRUG Creon Pancrelipase CAPSULE, DELAYED RELEASE PELLETS ORAL 20090929 NDA NDA020725 Physicians Total Care, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 12000; 38000; 60000 [USP'U]/1; [USP'U]/1; [USP'U]/1 E 20171231 54868-6069_b1023888-d89d-4c9f-9c22-c1722cdc204c 54868-6069 HUMAN PRESCRIPTION DRUG Actonel risedronate sodium TABLET, FILM COATED ORAL 20091005 NDA NDA020835 Physicians Total Care, Inc. RISEDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 54868-6070_7cccdc96-0f15-4755-9d18-9d74f55a815c 54868-6070 HUMAN PRESCRIPTION DRUG Exelon rivastigmine PATCH, EXTENDED RELEASE TRANSDERMAL 20091007 NDA NDA022083 Physicians Total Care, Inc. RIVASTIGMINE 4.6 mg/24[USP'U] Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 54868-6071_cdd1637a-0bda-4407-a4dd-4eccef86151d 54868-6071 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20091013 ANDA ANDA040350 Physicians Total Care, Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] E 20171231 54868-6072_e96fff12-7b42-4b58-8bd9-7b96eb2b120c 54868-6072 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20091015 ANDA ANDA076941 Physicians Total Care, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 54868-6073_f10bdd5f-6af1-4f57-ac08-c5627263ac51 54868-6073 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20091016 ANDA ANDA077802 Physicians Total Care, Inc. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-6074_9f42c78b-8bd4-413e-9e48-276ef6926eb2 54868-6074 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 20091016 NDA NDA020234 Physicians Total Care, Inc. CARBAMAZEPINE 400 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 54868-6075_d4bd0a6d-9832-4d55-b129-5d2134eeb6c4 54868-6075 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20091015 ANDA ANDA078858 Physicians Total Care, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-6076_d4bd0a6d-9832-4d55-b129-5d2134eeb6c4 54868-6076 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20091015 ANDA ANDA078858 Physicians Total Care, Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-6077_cca8b765-71be-4b37-8c7c-d6447a21e00a 54868-6077 HUMAN PRESCRIPTION DRUG Vimpat lacosamide TABLET, FILM COATED ORAL 20091022 NDA NDA022253 Physicians Total Care, Inc. LACOSAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV E 20171231 54868-6078_803d538c-3eeb-4c67-97a1-40da1861fc84 54868-6078 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20091209 ANDA ANDA076388 Physicians Total Care, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 54868-6082_c031d46a-1f80-4600-ab2e-ff0b6e267e2a 54868-6082 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 20091028 ANDA ANDA079088 Physicians Total Care, Inc RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6083_88cfbec5-a553-46d5-bbfc-2c3a29b7f171 54868-6083 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 20091030 NDA NDA021087 Physicians Total Care, Inc. OSELTAMIVIR PHOSPHATE 45 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] E 20171231 54868-6085_1e319b95-24f3-4b75-8d58-b96ef68d8651 54868-6085 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20030903 ANDA ANDA075410 Physicians Total Care, Inc. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 54868-6086_c6479658-c5ee-4c63-9101-6bededba3cd2 54868-6086 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091117 ANDA ANDA077255 Physicians Total Care, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 54868-6087_e1c35407-b232-4a2d-ae2d-ff942ef35ce0 54868-6087 HUMAN PRESCRIPTION DRUG FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100107 NDA NDA020786 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CV E 20171231 54868-6088_ec4d96db-d1ec-4654-91f8-15324a5a104c 54868-6088 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091120 ANDA ANDA078445 Physicians Total Care, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 54868-6089_60dc7288-1d4d-4cb4-9faf-aecf3b9ae870 54868-6089 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100611 ANDA ANDA077135 Physicians Total Care, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 54868-6090_60dc7288-1d4d-4cb4-9faf-aecf3b9ae870 54868-6090 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20091203 ANDA ANDA077135 Physicians Total Care, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 54868-6091_276e3274-fac6-4ead-ad69-89d65bb11fba 54868-6091 HUMAN PRESCRIPTION DRUG Taclonex Scalp calcipotriene and betamethasone dipropionate SUSPENSION TOPICAL 20091210 NDA NDA022185 Physicians Total Care, Inc. CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE 50; .643 ug/g; mg/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6093_e3ca07e3-30a1-4d8a-85b2-0b012c9d9080 54868-6093 HUMAN PRESCRIPTION DRUG REQUIP XL ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091218 NDA NDA022008 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-6094_cac38eb9-dc7f-4ce6-99b6-c65d10caf2f8 54868-6094 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate brimonidine tartrate SOLUTION OPHTHALMIC 20091222 NDA NDA021764 Physicians Total Care, Inc. BRIMONIDINE TARTRATE 1.5 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 54868-6096_82e68d4e-ed88-4842-a61b-4987c4119d69 54868-6096 HUMAN PRESCRIPTION DRUG Altabax retapamulin OINTMENT TOPICAL 20100107 NDA NDA022055 Physicians Total Care, Inc. RETAPAMULIN 10 mg/g pleuromutilin [Chemical/Ingredient],Pleuromutilin Antibacterial [EPC] E 20171231 54868-6097_11c40932-8c8f-4a48-8b1f-c0fa4c7dbaa7 54868-6097 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20100114 ANDA ANDA076187 Physicians Total Care, Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 54868-6099_f9124873-60f0-4947-a483-f4629b8077e2 54868-6099 HUMAN PRESCRIPTION DRUG DEXAMETHASONE Sodium Phosphate Dexamethasone INJECTION INTRAMUSCULAR; INTRAVENOUS 20100115 ANDA ANDA081126 Physicians Total Care, Inc. DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6100_7c74ca49-b7e0-4b27-91e7-132a2359a5dc 54868-6100 HUMAN PRESCRIPTION DRUG Loestrin 24 Fe norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20100128 NDA NDA021871 Physicians Total Care, Inc. E 20171231 54868-6102_3a7a371f-b5ed-4289-9462-548cb57122a3 54868-6102 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20100407 ANDA ANDA040445 Physicians Total Care, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 54868-6103_3a41bc46-8bba-4c61-9299-3108f05a0d4d 54868-6103 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20100413 NDA NDA022107 Physicians Total Care, Inc. ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-6104_fbd6b677-f2fb-40ca-badb-81e6bac27d3f 54868-6104 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100413 ANDA ANDA076958 Physicians Total Care, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-6105_db793c72-3826-4b5c-a32a-952cd3d85cd9 54868-6105 HUMAN OTC DRUG Lamisil Terbinafine Hydrochloride SPRAY TOPICAL 20100413 NDA NDA021124 Physicians Total Care, Inc. TERBINAFINE HYDROCHLORIDE 1.25 mL/125mL E 20171231 54868-6106_5d1f4a78-f738-4bff-8713-6bc897e4fb67 54868-6106 HUMAN OTC DRUG Mucinex DM Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20100419 NDA NDA021620 Physicians Total Care, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 E 20171231 54868-6107_fbd6b677-f2fb-40ca-badb-81e6bac27d3f 54868-6107 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100413 ANDA ANDA076958 Physicians Total Care, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-6108_587513fd-ac8b-4ee3-955d-9415b299b5d4 54868-6108 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100419 ANDA ANDA077157 Physicians Total Care, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-6109_587513fd-ac8b-4ee3-955d-9415b299b5d4 54868-6109 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100419 ANDA ANDA077157 Physicians Total Care, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-6110_587513fd-ac8b-4ee3-955d-9415b299b5d4 54868-6110 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100419 ANDA ANDA077157 Physicians Total Care, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-6111_485c2855-f3f6-42cc-81cd-669d454366d7 54868-6111 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100420 ANDA ANDA077724 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-6112_24522f17-ad4c-4957-87ec-5a66cffb6e24 54868-6112 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20100420 ANDA ANDA076615 Physicians Total Care, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-6114_bd9828d4-5f5f-4afa-bf84-1a2d299d5cab 54868-6114 HUMAN PRESCRIPTION DRUG Differin adapalene LOTION TOPICAL 20100427 NDA NDA022502 Physicians Total Care, Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-6115_8b3759e9-e20f-433d-acdb-173863e2b2ae 54868-6115 HUMAN PRESCRIPTION DRUG Xyzal levocetirizine dihydrochloride SOLUTION ORAL 20100427 NDA NDA022157 Physicians Total Care, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 54868-6116_3d4b67bb-e159-4b4f-aa17-624515cd639f 54868-6116 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole POWDER, FOR SUSPENSION ORAL 20100427 NDA AUTHORIZED GENERIC NDA020090 Physicians Total Care, Inc. FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 54868-6117_fbd6b677-f2fb-40ca-badb-81e6bac27d3f 54868-6117 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100427 ANDA ANDA076958 Physicians Total Care, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-6118_3771fabc-7d2e-47f6-afe7-583101ac2663 54868-6118 HUMAN PRESCRIPTION DRUG Fenoglide fenofibrate TABLET ORAL 20100428 NDA NDA022118 Physicians Total Care, Inc. FENOFIBRATE 120 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 54868-6121_485c2855-f3f6-42cc-81cd-669d454366d7 54868-6121 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100503 ANDA ANDA077724 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-6122_8f85671a-7f36-42ac-b237-feef70a67864 54868-6122 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate OINTMENT OPHTHALMIC 20100504 ANDA ANDA062166 Physicians Total Care, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE ACETATE 3.5; 10000; 400; 10 mg/g; [USP'U]/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6123_8bc4df4b-1f3b-46a4-a17a-011d24b1e2b9 54868-6123 HUMAN PRESCRIPTION DRUG Exforge HCT amlodipine valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20100514 NDA NDA022314 Physicians Total Care, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 320; 25 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 54868-6124_cf206f2d-793d-4301-a75a-ed2b1d90ba4c 54868-6124 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100517 ANDA ANDA078306 Physicians Total Care, Inc. VERAPAMIL HYDROCHLORIDE 200 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-6125_5d79fc6e-7e80-4b19-863d-87e0ae57cfe2 54868-6125 HUMAN OTC DRUG Childrens Mucinex Cough Guaifenesin and Dextromethorphan Hydrobromide SOLUTION ORAL 20100519 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 5 mg/5mL; mg/5mL E 20171231 54868-6126_a706be2f-5593-485d-8791-b7aa923e2dfd 54868-6126 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate gentamicin sulfate OINTMENT TOPICAL 20100602 ANDA ANDA062533 Physicians Total Care, Inc. GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 54868-6127_5d36e1b8-3f6e-4ff2-829b-17f6f69b6250 54868-6127 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100611 NDA NDA022104 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-6128_d35cb135-1059-4acd-8c5b-86f33f4a6200 54868-6128 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, EXTENDED RELEASE ORAL 20101117 ANDA ANDA078783 Physicians Total Care, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 54868-6129_f10bdd5f-6af1-4f57-ac08-c5627263ac51 54868-6129 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20100623 ANDA ANDA077802 Physicians Total Care, Inc. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-6130_abee0b23-ecb8-49a1-847e-6bb088e2bfea 54868-6130 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100701 ANDA ANDA079220 Physicians Total Care, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 54868-6131_32c5651e-9e68-4bd6-a694-a809cd7c181f 54868-6131 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride azelastine hydrochloride SPRAY, METERED NASAL 20110628 ANDA ANDA077954 Physicians Total Care, Inc. AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 54868-6132_1d8895b4-2882-4a9e-95fb-646e8d8d1367 54868-6132 HUMAN PRESCRIPTION DRUG Adapalene Adapalene GEL TOPICAL 20100709 ANDA ANDA090962 Physicians Total Care, Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-6133_2ba7e0fa-a7ca-4cc9-a6e8-5929d5dfe73c 54868-6133 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20100809 ANDA ANDA076932 Physicians Total Care, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] E 20171231 54868-6136_ab2d1f67-4b2a-4b51-ba4d-7a01b8577549 54868-6136 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride FOR SUSPENSION ORAL 20100722 NDA NDA022362 Physicians Total Care, Inc. COLESEVELAM HYDROCHLORIDE 3.75 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] E 20171231 54868-6137_c2df194f-9b49-423d-83eb-ac96ab972079 54868-6137 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20100818 ANDA ANDA077806 Physicians Total Care, Inc. BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 54868-6138_e8b2ce9c-39b3-4a1b-97fd-c95233a4d6bb 54868-6138 HUMAN PRESCRIPTION DRUG PEG-3350 and Electrolytes PEG-3350 and Electrolytes POWDER, FOR SOLUTION ORAL 20100820 NDA AUTHORIZED GENERIC NDA019011 Physicians Total Care, Inc. POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE 236; 22.74; 6.74; 5.86; 2.97 g/2L; g/2L; g/2L; g/2L; g/2L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-6139_001447cf-1dad-47bf-be69-f41d581dd21d 54868-6139 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101108 ANDA ANDA076565 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-6140_001447cf-1dad-47bf-be69-f41d581dd21d 54868-6140 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100802 ANDA ANDA076565 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-6141_001447cf-1dad-47bf-be69-f41d581dd21d 54868-6141 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101108 ANDA ANDA076565 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-6145_988e5b01-81d6-4f88-befc-895e755dfb77 54868-6145 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate rivastigmine tartrate CAPSULE ORAL 20100915 ANDA ANDA077131 Physicians Total Care, Inc. RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 54868-6146_7af60e76-41ca-4324-8f44-c6cc00fdd694 54868-6146 HUMAN PRESCRIPTION DRUG Norditropin somatropin INJECTION, SOLUTION SUBCUTANEOUS 20100810 NDA NDA021148 Physicians Total Care, Inc. SOMATROPIN 5 mg/1.5mL Recombinant Human Growth Hormone [EPC],Recombinant Human Growth Hormones [Chemical/Ingredient] E 20171231 54868-6147_5184c8dc-937f-401c-b359-93717cd37476 54868-6147 HUMAN PRESCRIPTION DRUG Canasa mesalamine SUPPOSITORY RECTAL 20100818 NDA NDA021252 Physicians Total Care, Inc. MESALAMINE 1000 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 54868-6148_5be0bfc5-80d8-4f8a-afe3-eafa62312d38 54868-6148 HUMAN PRESCRIPTION DRUG Adapalene Adapalene CREAM TOPICAL 20101001 ANDA ANDA090824 Physicians Total Caer, Inc. ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-6150_d0294c21-ce61-46a3-a62e-11cfed40c8d9 54868-6150 HUMAN PRESCRIPTION DRUG APRISO mesalamine CAPSULE, EXTENDED RELEASE ORAL 20100818 NDA NDA022301 Physicians Total Care, Inc. MESALAMINE 375 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 54868-6151_d6005cba-5d7d-4540-b1f2-5715e0870693 54868-6151 HUMAN PRESCRIPTION DRUG Pylera Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride (140 mg/125 mg/125 mg) CAPSULE ORAL 20100818 NDA NDA050786 Physicians Total Care, Inc. BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE 140; 125; 125 mg/1; mg/1; mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient],Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 54868-6152_f517d5f1-7d2e-4231-822d-e28898925664 54868-6152 HUMAN PRESCRIPTION DRUG Dexilant dexlansoprazole CAPSULE, DELAYED RELEASE ORAL 20100819 NDA NDA022287 Physicians Total Care, Inc. DEXLANSOPRAZOLE 60 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 54868-6153_f534208b-95b9-449a-83bc-5f6dc33b4ea7 54868-6153 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20100819 NDA NDA021908 Physicians Total Care, Inc. LUBIPROSTONE 8 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] E 20171231 54868-6154_75eebf07-eadb-4b8d-b67c-a5a5780dcfdf 54868-6154 HUMAN PRESCRIPTION DRUG XIFAXAN RIFAXIMIN TABLET ORAL 20100819 NDA NDA022554 Physicians Total Care, Inc. RIFAXIMIN 550 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 54868-6155_c7ba3463-0eee-4b4f-a4e6-369711c2f6be 54868-6155 HUMAN PRESCRIPTION DRUG Tindamax tinidazole TABLET, FILM COATED ORAL 20100823 NDA NDA021618 Physicians Total Care, Inc. TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 54868-6156_16d63980-82e0-4bdf-a98b-4bb6640ad5a5 54868-6156 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100823 NDA NDA022030 Physicians Total Care, Inc. FESOTERODINE FUMARATE 4 mg/1 E 20171231 54868-6157_978cf43f-09f5-45f1-84e4-27caa1fda33a 54868-6157 HUMAN PRESCRIPTION DRUG Evamist estradiol SPRAY, METERED TRANSDERMAL 20100823 NDA NDA022014 Physicians Total Care, Inc. ESTRADIOL 1.53 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-6159_485c2855-f3f6-42cc-81cd-669d454366d7 54868-6159 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100823 ANDA ANDA077724 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-6160_8d38d308-d218-4f4e-b7bf-e29acb3a8c56 54868-6160 HUMAN PRESCRIPTION DRUG Terconazole terconazole CREAM VAGINAL 20100824 ANDA ANDA076712 Physicians Total Care, Inc. TERCONAZOLE 4 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] E 20171231 54868-6161_65ae4b2a-4882-412d-8aab-1f4fafc496ff 54868-6161 HUMAN PRESCRIPTION DRUG FEMCON Fe norethindrone and ethinyl estradiol, and ferrous fumarate KIT 20100921 NDA NDA021490 Physicians Total Care, Inc. E 20171231 54868-6162_e5c8e9c5-421d-4db2-adc4-01bbd85aeb43 54868-6162 HUMAN PRESCRIPTION DRUG GIANVI drospirenone and ethinyl estradiol KIT 20101021 ANDA ANDA078515 Physicians Total Care, Inc. E 20171231 54868-6163_4d771c59-9794-43b9-bef4-5fdf96c2fe80 54868-6163 HUMAN PRESCRIPTION DRUG ENJUVIA synthetic conjugated estrogens, B TABLET ORAL 20100903 NDA NDA021443 Physicians Total Care, Inc. ESTROGENS, CONJUGATED SYNTHETIC B .625 mg/1 E 20171231 54868-6164_4d771c59-9794-43b9-bef4-5fdf96c2fe80 54868-6164 HUMAN PRESCRIPTION DRUG ENJUVIA synthetic conjugated estrogens, B TABLET ORAL 20100903 NDA NDA021443 Physicians Total Care, Inc. ESTROGENS, CONJUGATED SYNTHETIC B .3 mg/1 E 20171231 54868-6165_4d771c59-9794-43b9-bef4-5fdf96c2fe80 54868-6165 HUMAN PRESCRIPTION DRUG ENJUVIA synthetic conjugated estrogens, B TABLET ORAL 20100903 NDA NDA021443 Physicians Total Care, Inc. ESTROGENS, CONJUGATED SYNTHETIC B .9 mg/1 E 20171231 54868-6167_af99b509-0cf2-40cb-9198-40414a82ca46 54868-6167 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, COATED ORAL 20100908 ANDA ANDA078230 Physicians Total Care, Inc. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-6168_8f31bccd-974a-40a1-aeba-578cd42d2700 54868-6168 HUMAN PRESCRIPTION DRUG Veramyst fluticasone furoate SPRAY, METERED NASAL 20100907 NDA NDA022051 Physicians Total Care, Inc. FLUTICASONE FUROATE 27.5 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6169_85d265f2-9b74-42d3-9b33-c34573be8c1e 54868-6169 HUMAN PRESCRIPTION DRUG Simcor simvastatin and niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100914 NDA NDA022078 Physicians Total Care, Inc. SIMVASTATIN; NIACIN 40; 1000 mg/1; mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 54868-6170_fad3dfbe-5257-4305-ac6e-d7a6a4befae8 54868-6170 HUMAN PRESCRIPTION DRUG Leflunomide leflunomide TABLET, FILM COATED ORAL 20100917 ANDA ANDA077087 Physicians Total Care, Inc. LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] E 20171231 54868-6171_b87eb0de-eb1d-4ece-833b-b4f2c9c0210f 54868-6171 HUMAN PRESCRIPTION DRUG GELNIQUE oxybutynin chloride GEL TRANSDERMAL 20100915 NDA NDA022204 Physicians Total Care, Inc. OXYBUTYNIN CHLORIDE 100 mg/g Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-6173_9a9ef99a-a794-43c0-ba3e-169752985a92 54868-6173 HUMAN PRESCRIPTION DRUG RAPAFLO silodosin CAPSULE ORAL 20100915 NDA NDA022206 Physicians Total Care, Inc. SILODOSIN 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-6175_16d63980-82e0-4bdf-a98b-4bb6640ad5a5 54868-6175 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100915 NDA NDA022030 Physicians Total Care, Inc. FESOTERODINE FUMARATE 8 mg/1 E 20171231 54868-6176_09893986-19e0-4364-93ba-5fbc7e7d3eed 54868-6176 HUMAN PRESCRIPTION DRUG UROCIT-K potassium citrate TABLET, EXTENDED RELEASE ORAL 20100915 NDA NDA019071 Physicians Total Care, Inc. POTASSIUM CITRATE 15 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 54868-6178_a097b2cb-9177-4e62-a4b6-cd40fefe6c83 54868-6178 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101025 ANDA ANDA077873 Physicians Total Care, Inc. PAROXETINE HYDROCHLORIDE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-6179_aa69b361-6057-4a69-91b3-55681cb482b4 54868-6179 HUMAN PRESCRIPTION DRUG Imiquimod imiquimod CREAM TOPICAL 20100922 ANDA ANDA078548 Physicians Total Care, Inc. IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] E 20171231 54868-6181_b847a611-8ba0-43ec-b75c-09aeee36c2ee 54868-6181 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole GEL TOPICAL 20100924 ANDA ANDA077819 Physicians Total Care, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 54868-6182_ad9ebd92-2d74-4cac-aea3-3c33d3a9f116 54868-6182 HUMAN PRESCRIPTION DRUG Vagifem estradiol TABLET, FILM COATED VAGINAL 20100924 NDA NDA020908 Physicians Total Care, Inc. ESTRADIOL 10 ug/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-6183_3133bc7c-85c8-425b-990c-91f7b251bd71 54868-6183 HUMAN PRESCRIPTION DRUG Natazia estradiol valerate and estradiol valerate/dienogest KIT 20100929 NDA NDA022252 Physicians Total Care, Inc. E 20171231 54868-6184_381ff0dc-5960-485c-bc92-86e717e39c04 54868-6184 HUMAN PRESCRIPTION DRUG Angeliq drospirenone and estradiol TABLET, FILM COATED ORAL 20100929 NDA NDA021355 Physicians Total Care, Inc. ESTRADIOL; DROSPIRENONE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 54868-6185_3bb13bf6-83da-41af-afb5-46ccd13314a3 54868-6185 HUMAN PRESCRIPTION DRUG Claravis isotretinoin CAPSULE ORAL 20131004 ANDA ANDA076135 Physicians Total Care, Inc. ISOTRETINOIN 30 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-6186_7a41cfe2-4505-4db2-91e7-51493a47f497 54868-6186 HUMAN OTC DRUG Infant Glycerin Laxative Glycerin SUPPOSITORY RECTAL 20101027 OTC MONOGRAPH FINAL part334 Physicians Total Care, Inc. GLYCERIN 1.3 g/1 E 20171231 54868-6189_e5d3b2c1-fd39-4369-bce0-4db9ea8b3183 54868-6189 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101102 ANDA ANDA078179 Physicians Total Care, Inc. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 54868-6190_c2821be4-8191-4ddf-9235-d660b25a3590 54868-6190 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20101022 NDA AUTHORIZED GENERIC NDA050641 Physicians Total Care, Inc. DOXYCYCLINE 100 mg/1 E 20171231 54868-6192_6aec4d10-3bac-4afb-bb7f-6a0e23556143 54868-6192 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20101101 NDA AUTHORIZED GENERIC NDA021303 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-6193_d6d6402a-3913-4adf-b6e6-f4676533a3a5 54868-6193 HUMAN PRESCRIPTION DRUG Micardis TELMISARTAN TABLET ORAL 20101102 NDA NDA020850 Physicians Total Care, Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-6194_3a41bc46-8bba-4c61-9299-3108f05a0d4d 54868-6194 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20101103 NDA NDA022107 Physicians Total Care, Inc. ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 300; 25 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-6195_691a547f-2287-494d-854f-a3f65a2b971f 54868-6195 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine SOLUTION OPHTHALMIC 20101103 ANDA ANDA090017 Physicians Total Care, Inc. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 54868-6196_239fdd51-8d4c-4ffd-9aa4-bcf804eac4a3 54868-6196 HUMAN PRESCRIPTION DRUG Hydrocodone Polistirex and Chlorpheniramine Polistirex Hydrocodone Polistirex and Chlorpheniramine Polistirex SUSPENSION ORAL 20101103 ANDA ANDA091632 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE 10; 8 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII E 20171231 54868-6197_c6479658-c5ee-4c63-9101-6bededba3cd2 54868-6197 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101117 ANDA ANDA077255 Physicians Total Care, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 54868-6198_87ea2799-31b0-4369-a95c-8fd1b3da148a 54868-6198 HUMAN PRESCRIPTION DRUG Podofilox Podofilox SOLUTION TOPICAL 20101112 NDA AUTHORIZED GENERIC NDA019795 Physicians Total Care, Inc. PODOFILOX 5 mg/mL Decreased Mitosis [PE] E 20171231 54868-6201_c031d46a-1f80-4600-ab2e-ff0b6e267e2a 54868-6201 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 20101115 ANDA ANDA079088 Physicians Total Care, Inc RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6203_bd95b77f-57ef-45bf-826b-ed657c0df2c8 54868-6203 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/Macrocrystals Nitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline CAPSULE ORAL 20110106 ANDA ANDA076648 Physicians Total Care, Inc. NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 54868-6204_658613fc-a080-468d-b588-ce32ece3171b 54868-6204 HUMAN PRESCRIPTION DRUG Vanos fluocinonide CREAM TOPICAL 20101130 NDA NDA021758 Physicians Total Care, Inc. FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6205_bf2e8109-f748-4110-bdfb-23e4c43acdec 54868-6205 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20101130 ANDA ANDA078730 Physicians Total Care, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 54868-6206_9eddc1b7-4b71-4145-b097-2b1cb1abee9e 54868-6206 HUMAN PRESCRIPTION DRUG Azilect rasagiline mesylate TABLET ORAL 20101203 NDA NDA021641 Physicians Total Care, Inc. RASAGILINE MESYLATE 1 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] E 20171231 54868-6207_9dffbd3e-8046-45ac-b56e-538cde87b59b 54868-6207 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20101207 ANDA ANDA076786 Physicians Total Care, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 54868-6208_9dffbd3e-8046-45ac-b56e-538cde87b59b 54868-6208 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20101227 ANDA ANDA076786 Physicians Total Care, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 54868-6209_2405423b-da88-4bfb-a366-1f19ecaf341a 54868-6209 HUMAN OTC DRUG Docusate Sodium Docusate Sodium LIQUID ORAL 20101207 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. DOCUSATE SODIUM 50 mg/5mL E 20171231 54868-6210_110b472e-8a7b-48e1-9d79-d02066dda224 54868-6210 HUMAN PRESCRIPTION DRUG Lutera Levonorgestrel and Ethinyl Estradiol KIT 20101213 ANDA ANDA076625 Physicians Total Care, Inc. E 20171231 54868-6211_b02b798f-01b7-491e-8802-11057828e6f6 54868-6211 HUMAN PRESCRIPTION DRUG Menest Estrogens, esterified TABLET ORAL 20101209 ANDA ANDA084951 Physicians Total Care, Inc. ESTROGENS, ESTERIFIED .3 mg/1 E 20171231 54868-6212_b02b798f-01b7-491e-8802-11057828e6f6 54868-6212 HUMAN PRESCRIPTION DRUG Menest Estrogens, esterified TABLET ORAL 20101216 ANDA ANDA084950 Physicians Total Care, Inc. ESTROGENS, ESTERIFIED 1.25 mg/1 E 20171231 54868-6213_2da371ca-e885-413a-849b-cc6a10ac6219 54868-6213 HUMAN PRESCRIPTION DRUG Microgestin Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20101213 ANDA ANDA075647 Physicians Total Care, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; .02 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-6214_f72892dc-01cf-4e66-a841-aae20aa65500 54868-6214 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH TRANSDERMAL 20101214 ANDA ANDA076157 Physicians Total Care, Inc. CLONIDINE .2 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54868-6215_035d775b-7280-44af-be40-223e3e66d7fc 54868-6215 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101216 NDA NDA021774 Physicians Total Care, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 54868-6219_7de0ea4c-1210-47b8-96c3-c6fa763d1c1d 54868-6219 HUMAN PRESCRIPTION DRUG Ethambutol Ethambutol hydrochloride TABLET, FILM COATED ORAL 20101220 ANDA ANDA075095 Physicians Total Care, Inc. ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] E 20171231 54868-6220_603d0174-6801-4fa0-bca9-23cd3aa86dfe 54868-6220 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20101222 ANDA ANDA077401 Physicians Total Care, Inc. MOMETASONE FUROATE 1 mg/g E 20171231 54868-6221_afc7725d-445d-42bf-b41c-f4614121710b 54868-6221 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20101229 ANDA ANDA077634 Physicians Total Care, Inc. ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-6222_00904221-c0c7-49bd-b00a-8689a2a5a386 54868-6222 HUMAN PRESCRIPTION DRUG Pataday olopatadine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20110103 NDA NDA021545 Physicians Total Care, Inc. OLOPATADINE HYDROCHLORIDE 2 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] E 20171231 54868-6223_22703ed4-6d7f-4caa-9bac-399719e8e447 54868-6223 HUMAN OTC DRUG Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20110113 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 54868-6224_64554bc4-3743-440f-ac7d-ee3e65413c99 54868-6224 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20110114 ANDA ANDA077171 Physicians Total Care, Inc. CLONAZEPAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 54868-6225_bd548d56-474a-4581-8427-f866b4e7c2db 54868-6225 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SUSPENSION TOPICAL 20110119 ANDA ANDA077015 Physicians Total Care, Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 54868-6227_6aec4d10-3bac-4afb-bb7f-6a0e23556143 54868-6227 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20110303 NDA AUTHORIZED GENERIC NDA021303 Physicians Total Care, Inc. DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-6231_929a6a1f-8668-425d-aec4-15793be80ea7 54868-6231 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20110207 NDA NDA021081 Physicians Total Care, Inc. INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 54868-6232_fedee476-b4b4-47d3-93d4-8d9665ee3c64 54868-6232 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20110210 ANDA ANDA065110 Physicians Total Care, Inc. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 54868-6233_3fb77464-a314-4880-8da2-fec6bb912db3 54868-6233 HUMAN OTC DRUG Cold Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20110216 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 54868-6234_79201e83-d9e6-42a7-98b6-bd51edbdc233 54868-6234 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110302 NDA NDA021259 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-6237_485c2855-f3f6-42cc-81cd-669d454366d7 54868-6237 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20110408 ANDA ANDA077724 Physicians Total Care, Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 54868-6238_315dd1fe-0930-43f1-b574-a5f5e7f6f7a3 54868-6238 HUMAN PRESCRIPTION DRUG Effient Prasugrel hydrochloride TABLET, FILM COATED ORAL 20110315 NDA NDA022307 Physicians Total Care, Inc. PRASUGREL HYDROCHLORIDE 10 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] E 20171231 54868-6239_184f97d8-240b-46c5-ba36-c8b51aa988a3 54868-6239 HUMAN PRESCRIPTION DRUG EPINEPHRINE epinephrine INJECTION SUBCUTANEOUS 20110418 NDA NDA020800 Physicians Total Care, Inc. EPINEPHRINE .3 mg/1 Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 54868-6241_67e1dbc2-7747-4971-8916-e0bca4f7293f 54868-6241 HUMAN OTC DRUG ENTEX LQ guaifenesin and phenylephrine hydrochloride LIQUID ORAL 20110401 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 100; 10 mg/5mL; mg/5mL E 20171231 54868-6243_c031d46a-1f80-4600-ab2e-ff0b6e267e2a 54868-6243 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET ORAL 20110408 ANDA ANDA079088 Physicians Total Care, Inc RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6246_dc77182b-f12d-4f92-a0c1-06cd63d6a68b 54868-6246 HUMAN PRESCRIPTION DRUG VUSION miconazole nitrate, zinc oxide, white petrolatum OINTMENT TOPICAL 20110418 NDA NDA021026 Physicians Total Care, Inc. MICONAZOLE NITRATE; ZINC OXIDE; PETROLATUM 2.5; 150; 813.5 mg/g; mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] E 20171231 54868-6247_ea19bd36-7cb9-4836-b1f3-a2b6c852906e 54868-6247 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET ORAL 20110422 ANDA ANDA078627 Physicians Total Care, Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-6248_0a8038cc-83a1-4e1d-8773-2c4958dd0183 54868-6248 HUMAN PRESCRIPTION DRUG HYDROCORTISONE BUTYRATE hydrocortisone butyrate CREAM TOPICAL 20110425 NDA NDA018514 Physicians Total Care, Inc. HYDROCORTISONE BUTYRATE 1 mg/g E 20171231 54868-6250_94cc0af7-0516-4ef0-8bfe-39f2708ef22e 54868-6250 HUMAN PRESCRIPTION DRUG Azor amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20110426 NDA NDA022100 Physicians Total Care, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-6251_4b31262e-a660-4648-ab54-45e8d18c6c5d 54868-6251 HUMAN PRESCRIPTION DRUG JINTELI norethindrone acetate and ethinyl estradiol TABLET ORAL 20110426 ANDA ANDA076221 Physicians Total Care, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; 5 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-6252_effc4ce8-4df7-4c94-86fd-a457323fba9b 54868-6252 HUMAN PRESCRIPTION DRUG LETROZOLE letrozole TABLET, FILM COATED ORAL 20110504 ANDA ANDA078190 Physicians Total Care, Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 54868-6253_96b4ed40-9853-4ac2-8b3a-4548355d1c40 54868-6253 HUMAN PRESCRIPTION DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN neomycin sulfate, polymyxin b sulfate and gramicidin SOLUTION/ DROPS OPHTHALMIC 20110426 ANDA ANDA064047 Physicians Total Care, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN 1.75; 10000; .025 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 54868-6254_f76f06af-da9c-4603-ae19-a5620e776c2f 54868-6254 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION/ DROPS OPHTHALMIC 20110621 ANDA ANDA201006 Physicians Total Care, Inc. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] E 20171231 54868-6255_57e523a5-55be-4d38-a5e0-0141447863bf 54868-6255 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20110503 ANDA ANDA077463 Physicians Total Care, Inc. NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] E 20171231 54868-6256_6429e27f-6b2a-477f-8f53-56fa6e1129d7 54868-6256 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20111019 NDA NDA022352 Physicians Total Care, Inc. COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] E 20171231 54868-6259_36f1f619-eff7-4e7b-a0d7-24c2a3db8a7e 54868-6259 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 20110505 ANDA ANDA072076 Physicians Total Care, Inc. NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] E 20171231 54868-6260_f72892dc-01cf-4e66-a841-aae20aa65500 54868-6260 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH TRANSDERMAL 20110510 ANDA ANDA076157 Physicians Total Care, Inc. CLONIDINE .3 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54868-6261_3589976f-2ec4-4f36-b93d-a70679fc67bb 54868-6261 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20110601 NDA AUTHORIZED GENERIC NDA021121 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-6262_3589976f-2ec4-4f36-b93d-a70679fc67bb 54868-6262 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20110601 NDA AUTHORIZED GENERIC NDA021121 Physicians Total Care, Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 54868-6265_d1f79ded-7451-46a7-9e44-ed60d9b396f2 54868-6265 HUMAN PRESCRIPTION DRUG Calcitriol calcitriol INJECTION, SOLUTION INTRAVENOUS 20110517 ANDA ANDA075746 Physicians Total Care, Inc. CALCITRIOL 1 mg/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 54868-6266_85c1bdec-b1ed-4394-9ace-359c4df7b4ef 54868-6266 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride hydralazine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110517 ANDA ANDA040730 Physicians Total Care, Inc. HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 54868-6269_d4bd0a6d-9832-4d55-b129-5d2134eeb6c4 54868-6269 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20110607 ANDA ANDA078858 Physicians Total Care, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-6270_fc40da6f-c716-4b68-83e4-0965a3af825f 54868-6270 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide SPRAY, METERED NASAL 20110914 ANDA ANDA078104 Physicians Total Care, Inc. TRIAMCINOLONE ACETONIDE 55 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6271_05616a7e-71b4-4009-a86d-c7fb31d27faa 54868-6271 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20110617 ANDA ANDA065431 Physicians Total Care, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 250; 62.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 54868-6272_01fd5716-bb59-49b0-a0ed-8da299cf060f 54868-6272 HUMAN PRESCRIPTION DRUG Junel 1.5/30 norethindrone acetate and ethinyl estradiol TABLET ORAL 20110621 ANDA ANDA076381 Physicians Total Care, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1.5; 30 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 54868-6273_a4c8ea03-e42f-4cc4-9e44-a36cbce1fc4d 54868-6273 HUMAN PRESCRIPTION DRUG Zenchent Norethindrone and Ethinyl Estradiol KIT 20110621 ANDA ANDA078323 Physicians Total Care, Inc. E 20171231 54868-6274_d4616da6-d4ac-447f-b557-fda34a016e10 54868-6274 HUMAN PRESCRIPTION DRUG Tilia Fe Norethindrone Acetate and Ethinyl Estradiol KIT ORAL 20110621 ANDA ANDA076629 Physicians Total Care, Inc. E 20171231 54868-6275_f3e8ce92-440e-4ecb-953e-ddf66db8e403 54868-6275 HUMAN PRESCRIPTION DRUG LoSeasonique levonorgestrel/ethinyl estradiol and ethinyl estradiol KIT 20110621 NDA NDA022262 Physicians Total Care, Inc. E 20171231 54868-6276_a5b8bc86-b90c-43cc-8778-2468f6c09cd4 54868-6276 HUMAN PRESCRIPTION DRUG Seasonique levonorgestrel / ethinyl estradiol and ethinyl estradiol KIT 20110621 NDA NDA021840 Physicians Total Care, Inc. E 20171231 54868-6277_bb6795d2-632e-4850-ad0c-5396ee97fdd9 54868-6277 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110915 ANDA ANDA076710 Physicians Total Care, Inc. LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-6278_bb6795d2-632e-4850-ad0c-5396ee97fdd9 54868-6278 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110622 ANDA ANDA076710 Physicians Total Care, Inc. LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-6279_bb6795d2-632e-4850-ad0c-5396ee97fdd9 54868-6279 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110622 ANDA ANDA076710 Physicians Total Care, Inc. LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-6280_749ca7b2-0317-497a-bc36-167f5c02dbf3 54868-6280 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20110718 NDA NDA021436 Physicians Total Care, Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6282_cdbc91cb-f696-4d5f-ab5e-449e4c48cbd9 54868-6282 HUMAN PRESCRIPTION DRUG Besivance Besifloxacin SUSPENSION OPHTHALMIC 20110713 NDA NDA022308 Physicians Total Care, Inc. BESIFLOXACIN 6 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 54868-6283_e2fbe47e-392e-40c1-b2cf-2e9cfe026aea 54868-6283 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20110719 ANDA ANDA078792 Physicians Total Care, Inc. DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-6284_b2a437d0-1579-4850-914f-f23e0b39b0fc 54868-6284 HUMAN PRESCRIPTION DRUG SPRIX ketorolac tromethamine SPRAY, METERED NASAL 20110720 NDA NDA022382 Physicians Total Care, Inc. KETOROLAC TROMETHAMINE 15.75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 54868-6285_492810e2-d2ef-4f32-99e7-4d670bb48acf 54868-6285 HUMAN PRESCRIPTION DRUG Solodyn minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110718 NDA NDA050808 Physicians Total Care, Inc. MINOCYCLINE HYDROCHLORIDE 80 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 54868-6286_3f282789-eb8c-4437-8f5a-69986949fd16 54868-6286 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 20110725 ANDA ANDA064134 Physicians Total Care, Inc. TOBRAMYCIN; DEXAMETHASONE 3; 1 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6287_5d435eaa-c02c-4dd2-8628-e95f1587024c 54868-6287 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate Brimonidine Tartrate SOLUTION/ DROPS OPHTHALMIC 20110725 ANDA ANDA076260 Physicians Total Care, Inc. BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 54868-6288_f84fc3bd-4e3a-4212-be3d-cbe5d92a9251 54868-6288 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Augmented Betamethasone Dipropionate LOTION TOPICAL 20110727 ANDA ANDA077111 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE .64 mg/mL E 20171231 54868-6289_f62c7f7c-def1-446d-a173-1dde2c3c714c 54868-6289 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET ORAL 20110727 ANDA ANDA076502 Physicians Total Care, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 E 20171231 54868-6290_2e7982e9-25ac-451a-8d68-df391e85d4fb 54868-6290 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20110729 ANDA ANDA201961 Physicians Total Care, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 54868-6291_1da15065-b1bd-4774-97de-0e260a4556dc 54868-6291 HUMAN PRESCRIPTION DRUG CLOBETASOL PROPIONATE clobetasol propionate AEROSOL, FOAM TOPICAL 20110816 NDA NDA021142 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6292_27503731-a76c-4dce-9519-5f960e4cd762 54868-6292 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20110906 ANDA ANDA078930 Physicians Total Care, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6293_14ccb636-1aea-4e6c-9084-e8aa05bd0edf 54868-6293 HUMAN PRESCRIPTION DRUG FLUOROURACIL fluorouracil CREAM TOPICAL 20110906 ANDA ANDA077524 Physicians Total Care, Inc. FLUOROURACIL 50 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 54868-6294_9fd799f7-9bd7-40c6-b003-d27ca9cb0f10 54868-6294 HUMAN PRESCRIPTION DRUG LASTACAFT alcaftadine SOLUTION/ DROPS OPHTHALMIC 20110819 NDA NDA022134 Physicians Total Care, Inc. ALCAFTADINE 2.5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 54868-6295_8d6fabef-2442-43f9-b3fa-1d92160beabf 54868-6295 HUMAN PRESCRIPTION DRUG COMBIGAN brimonidine tartrate, timolol maleate SOLUTION/ DROPS OPHTHALMIC 20110829 NDA NDA021398 Physicians Total Care, Inc. BRIMONIDINE TARTRATE; TIMOLOL MALEATE 2; 5 mg/mL; mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 54868-6296_7927cdc5-bfbb-458d-8279-657d4dd70991 54868-6296 HUMAN PRESCRIPTION DRUG DUREZOL DUREZOL EMULSION OPHTHALMIC 20110829 NDA NDA022212 Physicians Total Care, Inc. DIFLUPREDNATE .5 mg/mL E 20171231 54868-6297_6e2cdf3a-736b-4840-ab54-cfed2fad0d2e 54868-6297 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110830 ANDA ANDA090149 Physicians Total Care, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 54868-6299_dc94c5cc-f078-40a9-9e51-7a171dbe4f37 54868-6299 HUMAN PRESCRIPTION DRUG BEPREVE bepotastine besilate SOLUTION/ DROPS OPHTHALMIC 20110926 NDA NDA022288 Physicians Total Care, Inc. BEPOTASTINE 15 mg/mL Histamine-1 Receptor Antagonist [EPC] E 20171231 54868-6301_6801466b-ad95-4d88-bd41-d8a167d4d052 54868-6301 HUMAN PRESCRIPTION DRUG Bromday bromfenac SOLUTION/ DROPS OPHTHALMIC 20110930 NDA NDA021664 Physicians Total Care, Inc. BROMFENAC SODIUM .9 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-6302_edd9dcb2-c553-44a8-878e-61ad9642e2b5 54868-6302 HUMAN PRESCRIPTION DRUG Nevanac nepafenac SUSPENSION OPHTHALMIC 20110831 NDA NDA021862 Physicians Total Care, Inc. NEPAFENAC 1 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-6303_c97e8928-c19f-41bd-b3eb-c2c9b8d31437 54868-6303 HUMAN PRESCRIPTION DRUG ZYMAXID gatifloxacin SOLUTION/ DROPS OPHTHALMIC 20110831 NDA NDA022548 Physicians Total Care, Inc. GATIFLOXACIN 5 mg/mL E 20171231 54868-6304_79525f6c-c645-444a-acc1-93bc46edb8a1 54868-6304 HUMAN PRESCRIPTION DRUG LUMIGAN bimatoprost SOLUTION/ DROPS OPHTHALMIC 20110914 NDA NDA022184 Physicians Total Care, Inc. BIMATOPROST .1 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] E 20171231 54868-6305_73335920-b3f7-43fe-bfef-2b3ed50c1ed3 54868-6305 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate EMULSION TOPICAL 20110907 ANDA ANDA075325 Physicians Total Care, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6306_e4fe38fa-19f0-4476-9723-e51767dfeb78 54868-6306 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110908 ANDA ANDA075932 Physicians Total Care, Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 54868-6307_3bb13bf6-83da-41af-afb5-46ccd13314a3 54868-6307 HUMAN PRESCRIPTION DRUG Claravis isotretinoin CAPSULE ORAL 20110914 ANDA ANDA076135 Physicians Total Care, Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-6308_3bb13bf6-83da-41af-afb5-46ccd13314a3 54868-6308 HUMAN PRESCRIPTION DRUG Claravis isotretinoin CAPSULE ORAL 20110920 ANDA ANDA076135 Physicians Total Care, Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-6309_7640cf93-5a17-4129-829b-f4a77bbda31e 54868-6309 HUMAN PRESCRIPTION DRUG ONGLYZA SAXAGLIPTIN TABLET, FILM COATED ORAL 20110922 NDA NDA022350 Physicians Total Care, Inc. SAXAGLIPTIN HYDROCHLORIDE 5 mg/1 E 20171231 54868-6310_f72892dc-01cf-4e66-a841-aae20aa65500 54868-6310 HUMAN PRESCRIPTION DRUG Clonidine Clonidine PATCH TRANSDERMAL 20110924 ANDA ANDA076157 Physicians Total Care, Inc. CLONIDINE .1 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54868-6311_58971aed-8e11-476b-b52f-d0f60a37532a 54868-6311 HUMAN OTC DRUG Silace Docusate sodium SYRUP ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Physicians Total Care, Inc. DOCUSATE SODIUM 60 mg/15mL E 20171231 54868-6312_d30f22f1-8c60-4072-bcdb-ac5d41edb796 54868-6312 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 20110924 ANDA ANDA074091 Physicians Total Care, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 E 20171231 54868-6315_88cfbec5-a553-46d5-bbfc-2c3a29b7f171 54868-6315 HUMAN PRESCRIPTION DRUG Tamiflu Oseltamivir Phosphate POWDER, FOR SUSPENSION ORAL 20111103 NDA NDA021246 Physicians Total Care, Inc. OSELTAMIVIR PHOSPHATE 6 mg/mL Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] E 20171231 54868-6316_011fff61-3327-45a3-ba99-86c12b9c28f3 54868-6316 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111122 ANDA ANDA091430 Physicians Total Care, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 54868-6317_3a7c03fe-ca67-489d-a42d-0efedd312f08 54868-6317 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20111117 NDA NDA022047 Physicians Total Care, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6319_7253c7c7-5bb8-4cab-b5df-870da5afa189 54868-6319 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111202 ANDA ANDA076477 Physicians Total Care, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-6320_7253c7c7-5bb8-4cab-b5df-870da5afa189 54868-6320 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111202 ANDA ANDA076477 Physicians Total Care, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-6321_7253c7c7-5bb8-4cab-b5df-870da5afa189 54868-6321 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Physicians Total Care, Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-6322_7253c7c7-5bb8-4cab-b5df-870da5afa189 54868-6322 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111202 ANDA ANDA076477 Physicians Total Care, Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-6323_495988fd-328f-485b-9dc8-cfc1a47baa05 54868-6323 HUMAN PRESCRIPTION DRUG CALCITONIN SALMON CALCITONIN SALMON SPRAY, METERED NASAL 20111209 ANDA ANDA076979 Physicians Total Care, Inc. CALCITONIN SALMON 200 [iU]/.09mL Calcitonin [Chemical/Ingredient],Calcitonin [EPC] E 20171231 54868-6325_803d538c-3eeb-4c67-97a1-40da1861fc84 54868-6325 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120104 ANDA ANDA076388 Physicians Total Care, Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 54868-6326_5b1c1400-be20-4fd6-b6c5-e23cbbcc70bd 54868-6326 HUMAN PRESCRIPTION DRUG Flavoxate Hydrochloride Flavoxate hydrochloride TABLET, FILM COATED ORAL 20120104 ANDA ANDA076835 Physicians Total Care, Inc. FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 54868-6328_f4787f96-c069-4268-94ae-1f4124ce744f 54868-6328 HUMAN PRESCRIPTION DRUG JALYN dutasteride and tamsulosin hydrochloride CAPSULE ORAL 20120502 NDA NDA022460 Physicians Total Care, Inc. DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE .5; .4 mg/1; mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA],Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-6329_1181b5ce-a033-4c2b-9896-1ab91a2afa82 54868-6329 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120222 ANDA ANDA079013 Physicians Total Care, Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 54868-6330_a426eea0-b0a5-47b4-bbef-e7a99f7382ab 54868-6330 HUMAN PRESCRIPTION DRUG Dorzolamide HCl Dorzolamide HCl SOLUTION/ DROPS OPHTHALMIC 20120221 ANDA ANDA090143 Physicians Total Care, Inc. DORZOLAMIDE HYDROCHLORIDE 22.3 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] E 20171231 54868-6333_a9c924a5-bee1-42b4-b2e1-1c1e3a735d16 54868-6333 HUMAN PRESCRIPTION DRUG Staxyn vardenafil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20120308 NDA NDA200179 Physicians Total Care, Inc. VARDENAFIL HYDROCHLORIDE 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 54868-6335_0af0a750-cbab-47c1-94dd-0aeb79223118 54868-6335 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20120308 NDA AUTHORIZED GENERIC NDA021540 Physicians Total Care, Inc. AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 54868-6336_caa6984e-ab98-4bdd-bcef-815234f39cd6 54868-6336 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20120525 ANDA ANDA076273 Physicians Total Care, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 54868-6338_3cdc5675-e9d8-4fbf-ba64-76de322eb9ad 54868-6338 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Physicians Total Care, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6339_3cdc5675-e9d8-4fbf-ba64-76de322eb9ad 54868-6339 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Physicians Total Care, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6340_3cdc5675-e9d8-4fbf-ba64-76de322eb9ad 54868-6340 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Physicians Total Care, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6341_3cdc5675-e9d8-4fbf-ba64-76de322eb9ad 54868-6341 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Physicians Total Care, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6342_3cdc5675-e9d8-4fbf-ba64-76de322eb9ad 54868-6342 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120412 ANDA ANDA077380 Physicians Total Care, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6343_254b8a76-f73d-4eb1-91c5-d85317fe8d24 54868-6343 HUMAN PRESCRIPTION DRUG Bromfenac Bromfenac sodium SOLUTION/ DROPS OPHTHALMIC 20120413 ANDA ANDA201211 Physicians Total Care, Inc. BROMFENAC SODIUM 1.035 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 54868-6347_30bbf95e-6db5-4492-9a74-35def0e35cb5 54868-6347 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20120426 ANDA ANDA201759 Physicians Total Care, Inc. FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6348_d2feb064-34c3-4e0b-b296-7ee359e25714 54868-6348 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20120426 ANDA ANDA065302 Physicians Total Care, Inc. AZITHROMYCIN ANHYDROUS 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 54868-6352_7617cef4-5cf8-4679-af41-a5bf71fc6f7a 54868-6352 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole GEL VAGINAL 20120604 NDA AUTHORIZED GENERIC NDA020208 Physicians Total Care, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 54868-6355_08609137-e587-4a8f-a69e-cdd93d3aa81a 54868-6355 HUMAN PRESCRIPTION DRUG PRED MILD prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 20121101 NDA NDA017100 Physicians Total Care, Inc. PREDNISOLONE ACETATE 1.2 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6358_b53caa4a-514f-4516-8dd4-e86d830db65c 54868-6358 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120702 ANDA ANDA076000 Physicians Total Care, Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6360_95d80140-58d3-4503-ad30-7fb7bc80dc74 54868-6360 HUMAN PRESCRIPTION DRUG COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20130201 NDA NDA202123 Physicians Total Care, Inc. EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE 200; 25; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [Chemical/Ingredient],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 54868-6361_1006e476-bae4-4924-bb59-9f8a5bfaba73 54868-6361 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120809 ANDA ANDA078605 Physicians Total Care, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 54868-6362_1006e476-bae4-4924-bb59-9f8a5bfaba73 54868-6362 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120809 ANDA ANDA078723 Physicians Total Care, Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 54868-6363_1006e476-bae4-4924-bb59-9f8a5bfaba73 54868-6363 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120809 ANDA ANDA078723 Physicians Total Care, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 54868-6364_b53caa4a-514f-4516-8dd4-e86d830db65c 54868-6364 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120822 ANDA ANDA076000 Physicians Total Care, Inc. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6365_b53caa4a-514f-4516-8dd4-e86d830db65c 54868-6365 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120822 ANDA ANDA076000 Physicians Total Care, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 54868-6366_de3cdf95-dde1-4bc3-9149-c75f55197be5 54868-6366 HUMAN PRESCRIPTION DRUG Myorisan isotretinoin CAPSULE, LIQUID FILLED ORAL 20120823 ANDA ANDA076485 Physicians Total Care, Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-6368_26d15de0-e8b5-4f82-9c43-624f7f510a6a 54868-6368 HUMAN PRESCRIPTION DRUG Intelence etravirine TABLET ORAL 20121010 NDA NDA022187 Physicians Total Care, Inc. ETRAVIRINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 54868-6369_04f573ea-41f5-4891-b474-eb19b2e6caa2 54868-6369 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20121016 NDA NDA021976 Physicians Total Care, Inc. DARUNAVIR ETHANOLATE 600 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 54868-6370_5be54e0d-3b7a-44be-8af0-2c7c9e3f9dea 54868-6370 HUMAN PRESCRIPTION DRUG Viramune nevirapine TABLET, EXTENDED RELEASE ORAL 20130123 NDA NDA201152 Physicians Total Care, Inc. NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] E 20171231 54868-6375_babd0b6a-0ecb-49f3-b598-12eaac98db60 54868-6375 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20121016 NDA NDA021323 Physicians Total Care, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-6376_babd0b6a-0ecb-49f3-b598-12eaac98db60 54868-6376 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20121016 NDA NDA021323 Physicians Total Care, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 54868-6377_31cfbadd-b2cf-45c1-b28b-266e12c3f8dd 54868-6377 HUMAN PRESCRIPTION DRUG BromfedDM DM Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide SYRUP ORAL 20121026 ANDA ANDA088811 Physicians Total Care, Inc. BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 2; 30; 10 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] E 20171231 54868-6378_de3cdf95-dde1-4bc3-9149-c75f55197be5 54868-6378 HUMAN PRESCRIPTION DRUG Myorisan isotretinoin CAPSULE, LIQUID FILLED ORAL 20121029 ANDA ANDA076485 Physicians Total Care, Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-6379_0cfa1b9a-07e6-4e7a-80c2-e62716be2abd 54868-6379 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride oxymorphone hydrochloride TABLET ORAL 20121210 ANDA ANDA090964 Physicians Total Care, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-6381_56e02cdd-dd44-419f-896c-9db80dc2f6f4 54868-6381 HUMAN OTC DRUG biclora Chlophedianol Hydrochloride, Chlorcyclizine Hydrochloride LIQUID ORAL 20130102 OTC MONOGRAPH FINAL part341 Physicians Total Care, Inc. CHLOPHEDIANOL HYDROCHLORIDE; CHLORCYCLIZINE HYDROCHLORIDE 12.5; 12.5 mg/5mL; mg/5mL E 20171231 54868-6383_82d5e146-c8ff-4a69-99d9-17345831c8aa 54868-6383 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20121207 ANDA ANDA201764 Physicians Total Care, Inc. FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6384_119e5ec4-4a4c-4ee1-9cfe-846290af31ca 54868-6384 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20121207 NDA AUTHORIZED GENERIC NDA021208 Physicians Total Care, Inc. MIRTAZAPINE 45 mg/1 E 20171231 54868-6387_92625c0a-0173-482e-85b5-ddcf79c261a9 54868-6387 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20121231 NDA NDA021217 Physicians Total Care, Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-6388_92625c0a-0173-482e-85b5-ddcf79c261a9 54868-6388 HUMAN PRESCRIPTION DRUG EXALGO Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20121231 NDA NDA021217 Physicians Total Care, Inc. HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 54868-6393_2deac9e5-a087-4ffc-a615-971a10d22ca5 54868-6393 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20130123 ANDA ANDA091211 Physicians Total Care, Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] E 20171231 54868-6394_b18741bc-0510-4cce-b98c-8669cf0bb9cb 54868-6394 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET ORAL 20130123 ANDA ANDA201967 Physicians Total Care, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 54868-6397_3f8c45b5-fd8c-41b5-acc9-efaa7c846733 54868-6397 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130129 ANDA ANDA078173 Physicians Total Care, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 54868-6406_d857b220-9912-4908-8733-f904a6402b8e 54868-6406 HUMAN PRESCRIPTION DRUG AXIRON testosterone SOLUTION TOPICAL 20130906 NDA NDA022504 Physicians Total Care, Inc. TESTOSTERONE 30 mg/1.5mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 54868-6407_54766c05-7e5a-4e05-96fe-0e81cd6885ae 54868-6407 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20131011 ANDA ANDA040355 Physicians Total Care, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 54868-6416_5a71f9d6-9f3f-47a3-ac53-d1e0208c6f72 54868-6416 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE Ketorolac Tromethamine SOLUTION/ DROPS OPHTHALMIC 20140328 NDA AUTHORIZED GENERIC NDA021528 Physicians Total Care, Inc. KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 54868-6423_5acf0cb0-1253-4e8d-8dd9-8e302089cee3 54868-6423 HUMAN PRESCRIPTION DRUG Sumatriptan SUMATRIPTAN TABLET ORAL 20090813 ANDA ANDA076554 Physicians Total Care, Inc. SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 54868-6425_3bb8e94b-5395-4d6b-a835-12aa4570a5dd 54868-6425 HUMAN PRESCRIPTION DRUG ZENATANE ISOTRETINOIN CAPSULE, GELATIN COATED ORAL 20140516 ANDA ANDA202099 Physicians Total Care, Inc. ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-6426_3bb8e94b-5395-4d6b-a835-12aa4570a5dd 54868-6426 HUMAN PRESCRIPTION DRUG ZENATANE ISOTRETINOIN CAPSULE, GELATIN COATED ORAL 20140516 ANDA ANDA202099 Physicians Total Care, Inc. ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 54868-6435_eaa6c757-097c-4e9a-84b4-e4dfc403e18a 54868-6435 HUMAN PRESCRIPTION DRUG ZENPEP pancrelipase CAPSULE, DELAYED RELEASE ORAL 20140912 NDA NDA022210 Physicians Total Care, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 10000; 34000; 55000 [USP'U]/1; [USP'U]/1; [USP'U]/1 E 20171231 54868-6437_6a2d0700-c293-4469-a52e-122e609182b7 54868-6437 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate, Acetaminophen SOLUTION ORAL 20140912 ANDA ANDA040894 Physicians Total Care, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 54868-6439_f04083e0-111f-455c-ab72-35303192530a 54868-6439 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 NDA NDA020741 Physicians Total Care, Inc. REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] E 20171231 54868-6440_1a30fdf5-041d-4498-ab52-469bc52ed05b 54868-6440 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20141201 NDA AUTHORIZED GENERIC NDA020818 Physicians Total Care, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-6447_020879e4-09a2-48f9-8376-33ffb12a44d6 54868-6447 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 19951017 ANDA ANDA074145 Physicians Total Care, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 54868-6452_d2b8ccb8-ce92-4ac2-b058-5c154f9bc3e3 54868-6452 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA077530 Physicians Total Care, Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-6453_d2b8ccb8-ce92-4ac2-b058-5c154f9bc3e3 54868-6453 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA077530 Physicians Total Care, Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-6455_1df299e4-52e0-458d-8979-0d3c6da4191c 54868-6455 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20120430 ANDA ANDA075467 Physicians Total Care, Inc. BUSPIRONE HYDROCHLORIDE 7.5 mg/1 E 20171231 54868-6457_79343013-31af-407b-8e8a-0bea12985559 54868-6457 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120927 ANDA ANDA202414 Physicians Total Care, Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 54868-6458_d2b8ccb8-ce92-4ac2-b058-5c154f9bc3e3 54868-6458 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA077530 Physicians Total Care, Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 54868-6461_601d3c0b-e5c8-41c0-9fa9-89d4b96279f5 54868-6461 HUMAN PRESCRIPTION DRUG Jentadueto linagliptin TABLET, FILM COATED ORAL 20120213 NDA NDA201281 Physicians Total Care, Inc. LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 54868-6624_53d9403e-108e-41aa-9d41-ff2719b8d682 54868-6624 HUMAN PRESCRIPTION DRUG METHYLPREDNISOLONE methylprednisolone TABLET ORAL 19941129 ANDA ANDA040232 Physicians Total Care, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 54868-6745_3608af1c-615a-4829-90bd-4a7c84a3a8b8 54868-6745 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 19930917 ANDA ANDA064048 Physicians Total Care, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 54879-001_2399c849-f6c5-4692-ab00-67d7ed818faf 54879-001 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20061215 NDA AUTHORIZED GENERIC NDA016320 STI Pharma LLC ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] N 20181231 54879-002_2399c849-f6c5-4692-ab00-67d7ed818faf 54879-002 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20061215 NDA AUTHORIZED GENERIC NDA016320 STI Pharma LLC ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] N 20181231 54879-003_fea33bd0-33c8-4c56-bf13-fb65462fe694 54879-003 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone ELIXIR ORAL 19760921 ANDA ANDA084754 STI Pharma LLC DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54879-004_d1707ea7-8ee4-4909-8a17-164107331dee 54879-004 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate LOTION CUTANEOUS 19850731 ANDA ANDA070052 STI Pharma LLC BETAMETHASONE VALERATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 54879-005_71f3d0dd-fdc0-4aed-9026-00ef91276ce0 54879-005 HUMAN PRESCRIPTION DRUG Triacin-C TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP SYRUP ORAL 20130101 ANDA ANDA088704 STI Pharma LLC TRIPROLIDINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE 1.25; 30; 10 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV E 20171231 54879-006_2cd16e7a-22d9-4119-b146-51778a36a4ea 54879-006 HUMAN PRESCRIPTION DRUG Hydroxyzine HCl Hydroxyzine HCl SOLUTION ORAL 19820101 ANDA ANDA086880 STI Pharma LLC HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 54879-007_95ae9b0f-f4f9-499a-8e80-b05566d9048e 54879-007 HUMAN PRESCRIPTION DRUG SULFATRIM Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 19830701 NDA NDA018615 STI Pharma LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 54879-009_b33ea9f7-1fa9-4ba8-8a3c-6f9897015044 54879-009 HUMAN PRESCRIPTION DRUG escitalopram escitalopram TABLET, FILM COATED ORAL 20130912 ANDA ANDA077512 STI Pharma LLC ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54879-010_b33ea9f7-1fa9-4ba8-8a3c-6f9897015044 54879-010 HUMAN PRESCRIPTION DRUG escitalopram escitalopram TABLET, FILM COATED ORAL 20130912 ANDA ANDA077512 STI Pharma LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54879-011_b33ea9f7-1fa9-4ba8-8a3c-6f9897015044 54879-011 HUMAN PRESCRIPTION DRUG escitalopram escitalopram TABLET, FILM COATED ORAL 20130912 ANDA ANDA077512 STI Pharma LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 54879-025_9d7fc503-901d-4b77-b8d8-314ad4ebd211 54879-025 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20101115 ANDA ANDA065287 STI Pharma LLC DOXYCYCLINE HYCLATE 20 mg/1 E 20171231 54879-026_9d6d119e-f188-4582-bdbd-b5f3949c9c83 54879-026 HUMAN PRESCRIPTION DRUG Butalbital And Acetaminophen butalbital and acetaminophen TABLET ORAL 20161115 ANDA ANDA203484 STI Pharma LLC BUTALBITAL; ACETAMINOPHEN 50; 325 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] E 20171231 54884-050_1ecbe16e-e5e7-4842-aff7-af45c9a50a76 54884-050 HUMAN OTC DRUG Nasal Decongestant Inhaler Levmetamfetamine Nasal Decongestant INHALANT NASAL 20160701 OTC MONOGRAPH FINAL part341 Aphena Pharma Solutions LEVMETAMFETAMINE 50 mg/1 N 20181231 54891-001_349765d3-ac03-48f9-ab37-5b92676b902f 54891-001 HUMAN OTC DRUG Viva Polysorbate 80 SOLUTION/ DROPS OPHTHALMIC 19870219 OTC MONOGRAPH FINAL part349 Dakota Laboratories, LLC POLYSORBATE 80 100 mg/10mL E 20171231 54897-507_7b7d2cf0-08d2-4ee2-b0ea-c5d77163acf8 54897-507 HUMAN PRESCRIPTION DRUG Topical Fluoride Foam Bumble Bee Bubble Gum Acidulated Phosphate Fluoride AEROSOL DENTAL 20000504 UNAPPROVED DRUG OTHER Laclede, Inc. SODIUM FLUORIDE; HYDROFLUORIC ACID 10; 2.3 mg/g; mg/g E 20171231 54897-601_87a1ddfc-60de-46e3-ab29-b775fe4b6d96 54897-601 HUMAN OTC DRUG LUVENA FEMININE WIPES Pramoxine Hydrochloride CLOTH TOPICAL 20120404 OTC MONOGRAPH FINAL part346 LACLEDE, INC. PRAMOXINE HYDROCHLORIDE 10 mg/1000mg E 20171231 54913-001_5e34ce06-6a67-7122-e053-2a91aa0a61bb 54913-001 HUMAN OTC DRUG SWEATBLOCK ALUMINUM CHLORIDE SOLUTION TOPICAL 20111026 OTC MONOGRAPH FINAL part350 DC Alpine Partners, LLC DBA SweatBlock ALUMINUM CHLORIDE 140 mg/mL N 20181231 54932-208_d32f5ca6-f036-4e26-acb3-bc8721ef2a72 54932-208 HUMAN OTC DRUG Codeine Phosphate and Guaifenesin codeine phosphate and guaifenesin LIQUID ORAL 20170117 OTC MONOGRAPH FINAL part341 BioRamo, LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV N 20181231 54948-100_128612bd-2440-432c-8858-53ab6a66aa55 54948-100 HUMAN OTC DRUG BAEKNYONDONGAN TREATMENT WITCH HAZEL SOLUTION TOPICAL 20110803 OTC MONOGRAPH FINAL part347 MIX & MATCH CO., LTD. WITCH HAZEL .55 mL/550mL E 20171231 54948-110_f3d5a97c-6e3f-4889-ac96-21d9d89e8ddd 54948-110 HUMAN OTC DRUG BAEKNYONDONGAN CHI WITCH HAZEL SHAMPOO TOPICAL 20110803 OTC MONOGRAPH FINAL part347 MIX & MATCH CO., LTD. WITCH HAZEL .55 mL/550mL E 20171231 54949-001_0b24b6a6-b51e-4c88-a98c-eb2f0ea35044 54949-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19861201 UNAPPROVED MEDICAL GAS ABCO Welding and Industrial Supply Inc OXYGEN 995 mL/L E 20171231 54949-002_75196dac-aea4-478a-9f4f-99795f72e091 54949-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19970812 UNAPPROVED MEDICAL GAS ABCO Welding and Industrial Supply Inc NITROGEN 990 mL/L E 20171231 54949-003_b827b4c7-d7ac-4373-aa49-d82141df1841 54949-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20100501 UNAPPROVED MEDICAL GAS ABCO Welding and Industrial Supply Inc. NITROUS OXIDE 990 mL/L E 20171231 54949-004_c865e683-db22-4e55-9814-a93b6848daea 54949-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20100501 UNAPPROVED MEDICAL GAS ABCO Welding and Industrial Supply Inc CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 54973-0229_5f009fc3-9513-347b-e053-2a91aa0a3603 54973-0229 HUMAN OTC DRUG ARNICAID arnica montana, hypericum perforatum, ruta graveolens flowering top, ledum palustre twig, and bellis perennis TABLET, SOLUBLE ORAL 19910717 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; LEDUM PALUSTRE TWIG; BELLIS PERENNIS 30; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-0232_5f006df2-adbc-3a60-e053-2a91aa0ab206 54973-0232 HUMAN OTC DRUG ARNISPORT arnica montana, hypericum perforatum, ruta graveolens flowering top, ledum palustre twig, bellis perennis, calcium fluoride, tribasic calcium phosphate, calcium sulfate anhydrous, ferrosoferric phosphate, potassium chloride, potassium phosphate, dibasic, potassium sulfate, magnesium phosphate, dibasic trihydrate, sodium chloride, sodium phosphate, dibasic, heptahydrate, sodium sulfate, and silicon dioxide TABLET, SOLUBLE ORAL 20000428 UNAPPROVED HOMEOPATHIC Hyland's HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; LEDUM PALUSTRE TWIG; BELLIS PERENNIS; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SILICON DIOXIDE; ARNICA MONTANA 6; 6; 6; 6; 6; 3; 3; 3; 3; 3; 3; 3; 6; 3; 3; 6; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-0600_5f1395df-c4b9-9436-e053-2a91aa0a8a8b 54973-0600 HUMAN OTC DRUG ACONITE NAPELLIS aconitum napellus root TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS ROOT 6 [hp_X]/1 N 20181231 54973-0601_5f26fb54-0f4c-0107-e053-2a91aa0a359a 54973-0601 HUMAN OTC DRUG ALLIUM CEPA onion TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ONION 6 [hp_X]/1 N 20181231 54973-0602_5f35d213-6f87-66cd-e053-2a91aa0a9f30 54973-0602 HUMAN OTC DRUG ANTIMONIUM TART antimony potassium tartrate TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ANTIMONY POTASSIUM TARTRATE 6 [hp_X]/1 N 20181231 54973-0603_5f362b64-664a-dc79-e053-2991aa0a2665 54973-0603 HUMAN OTC DRUG APIS MELLIFICA apis mellifera TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's APIS MELLIFERA 6 [hp_X]/1 N 20181231 54973-0604_5f372839-d254-cb7c-e053-2991aa0a818a 54973-0604 HUMAN OTC DRUG ARNICA MONTANA arnica montana TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA 6 [hp_X]/1 N 20181231 54973-0605_5f3bc292-f670-998a-e053-2a91aa0a1782 54973-0605 HUMAN OTC DRUG ARSENICUM ALBUM arsenic trioxide TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ARSENIC TRIOXIDE 6 [hp_X]/1 N 20181231 54973-0606_5f3c6b6c-7e9e-3d5b-e053-2a91aa0a4740 54973-0606 HUMAN OTC DRUG BELLADONNA atropa belladonna root TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ATROPA BELLADONNA ROOT 6 [hp_X]/1 N 20181231 54973-0607_5f9a7684-342c-fa97-e053-2a91aa0a3e09 54973-0607 HUMAN OTC DRUG BRYONIA ALBA bryonia alba root TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT 6 [hp_X]/1 N 20181231 54973-0609_5fa01762-fe5c-8a89-e053-2a91aa0a301c 54973-0609 HUMAN OTC DRUG CANTHARIS lytta vesicatoria TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's LYTTA VESICATORIA 6 [hp_X]/1 N 20181231 54973-0610_5fa05c98-f110-d59d-e053-2991aa0ae697 54973-0610 HUMAN OTC DRUG CARBO VEG activated charcoal TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ACTIVATED CHARCOAL 6 [hp_X]/1 N 20181231 54973-0611_51394c35-d1a6-0930-e054-00144ff8d46c 54973-0611 HUMAN OTC DRUG CHAMOMILLA matricaria chamomilla flowering top oil TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's MATRICARIA CHAMOMILLA FLOWERING TOP OIL 6 [hp_X]/1 N 20181231 54973-0613_60b9862e-0505-2b6a-e053-2a91aa0ab8e5 54973-0613 HUMAN OTC DRUG GELSEMIUM SEMP gelsemium sempervirens root TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]/1 N 20181231 54973-0614_60299bd3-f30b-6dbd-e053-2991aa0af8c7 54973-0614 HUMAN OTC DRUG HEPAR SULPH. CALC. calcium sulfide TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM SULFIDE 6 [hp_X]/1 N 20181231 54973-0615_603bd721-e4d4-feee-e053-2a91aa0aa315 54973-0615 HUMAN OTC DRUG HYPERICUM PERF hypericum perforatum TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's HYPERICUM PERFORATUM 6 [hp_X]/1 N 20181231 54973-0616_603dd6cb-0683-538a-e053-2991aa0a9fec 54973-0616 HUMAN OTC DRUG IGNATIA AMARA strychnos ignatii seed TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's STRYCHNOS IGNATII SEED 6 [hp_X]/1 N 20181231 54973-0617_603df544-ca77-9c90-e053-2a91aa0acab2 54973-0617 HUMAN OTC DRUG IPECACUANHA ipecac TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's IPECAC 6 [hp_X]/1 N 20181231 54973-0618_60500e32-4f97-5671-e053-2991aa0a73fb 54973-0618 HUMAN OTC DRUG LEDUM PAL. ledum palustre twig TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's LEDUM PALUSTRE TWIG 6 [hp_X]/1 N 20181231 54973-0620_60ded7af-5521-227a-e053-2a91aa0addb5 54973-0620 HUMAN OTC DRUG MERCURIUS VIVUS mercurius solubilis TABLET ORAL 19950101 UNAPPROVED HOMEOPATHIC Hyland's MERCURIUS SOLUBILIS 6 [hp_X]/1 N 20181231 54973-0621_6077c4c1-a3a6-7a7a-e053-2a91aa0a8a67 54973-0621 HUMAN OTC DRUG NUX VOMICA strychnos nux-vomica seed TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's STRYCHNOS NUX-VOMICA SEED 6 [hp_X]/1 N 20181231 54973-0622_6078598c-11f1-23f0-e053-2a91aa0af046 54973-0622 HUMAN OTC DRUG PHOSPHORUS phosphorus TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's PHOSPHORUS 6 [hp_X]/1 N 20181231 54973-0623_6078c812-9482-3be0-e053-2a91aa0aafb0 54973-0623 HUMAN OTC DRUG PULSATILLA NIG pulsatilla vulgaris TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's PULSATILLA VULGARIS 6 [hp_X]/1 N 20181231 54973-0624_6079ec2b-d51a-274a-e053-2a91aa0a57b2 54973-0624 HUMAN OTC DRUG RHUS TOX toxicodendron radicans leaf TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's TOXICODENDRON RADICANS LEAF 6 [hp_X]/1 N 20181231 54973-0625_6079d45c-dd53-6f2e-e053-2991aa0a9743 54973-0625 HUMAN OTC DRUG RUTA GRAV ruta graveolens flowering top TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X]/1 N 20181231 54973-0626_60a48e93-d3aa-36ed-e053-2a91aa0a975b 54973-0626 HUMAN OTC DRUG SPONGIA TOSTA spongia officinalis skeleton, roasted TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's SPONGIA OFFICINALIS SKELETON, ROASTED 6 [hp_X]/1 N 20181231 54973-0627_d44c19dc-6acf-4b3d-b886-ebd22774441d 54973-0627 HUMAN OTC DRUG SULPHUR SULFUR TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's SULFUR 6 [hp_X]/1 N 20181231 54973-0628_34b64130-46c8-43ff-961a-fd78ba31c688 54973-0628 HUMAN OTC DRUG VERATRUM ALBUM VERATRUM ALBUM ROOT TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's VERATRUM ALBUM ROOT 6 [hp_X]/1 N 20181231 54973-1068_5f50729f-2f7d-10ad-e053-2a91aa0af6ea 54973-1068 HUMAN OTC DRUG Bioplasma calcium fluoride, tribasic calcium phosphate, calcium sulfate anhydrous, ferrosoferric phosphate, potassium chloride, potassium phosphate, dibasic, potassium sulfate, magnesium phosphate, dibasic trihydrate, sodium chloride, sodium phosphate, dibasic, heptahydrate, sodium sulfate, and silicon dioxide TABLET, SOLUBLE ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SILICON DIOXIDE 6; 3; 3; 3; 3; 3; 3; 3; 6; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-1069_55165c40-432a-4785-e054-00144ff8d46c 54973-1069 HUMAN OTC DRUG BIOCHEMIC PHOSPHATE tribasic calcium phosphate, ferrosoferric phosphate, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, and sodium phosphate, dibasic, heptahydrate TABLET ORAL 19790919 UNAPPROVED HOMEOPATHIC Hyland's TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-1120_5567cbbc-644c-69dd-e054-00144ff88e88 54973-1120 HUMAN OTC DRUG CALMS NERVE TENSION SLEEPLESSNESS passiflora incarnata flower, avena sativa leaf, hops, and chamomile TABLET ORAL 19800101 UNAPPROVED HOMEOPATHIC Hyland's PASSIFLORA INCARNATA FLOWER; AVENA SATIVA LEAF; HOPS; CHAMOMILE 1; 1; 1; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-1129_6077411e-4101-3dfb-e053-2991aa0ac1e6 54973-1129 HUMAN OTC DRUG NERVE TONIC STRESS RELIEF calcium phosphate, iron, potassium phosphate, unspecified form, magnesium phosphate, dibasic trihydrate, and sodium phosphate TABLET ORAL 19700101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM PHOSPHATE; IRON; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-1130_60786358-513f-c7eb-e053-2a91aa0a451e 54973-1130 HUMAN OTC DRUG Poison Ivy/Oak toxicodendron radicans leaf, croton tiglium seed, and xerophyllum asphodeloides TABLET, SOLUBLE ORAL 19940101 UNAPPROVED HOMEOPATHIC Hyland's TOXICODENDRON RADICANS LEAF; CROTON TIGLIUM SEED; XEROPHYLLUM ASPHODELOIDES 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-1156_5f366d65-394b-4255-e053-2991aa0ae9ef 54973-1156 HUMAN OTC DRUG Arnicated Oil Arnica Montana OIL TOPICAL 19970217 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA 1 [hp_X]/mL N 20181231 54973-1157_603d1fea-53b3-e1b9-e053-2a91aa0ae69a 54973-1157 HUMAN OTC DRUG Hypericum hypericum perforatum SPRAY TOPICAL 20030806 UNAPPROVED HOMEOPATHIC Hyland's HYPERICUM PERFORATUM 1 [hp_X]/mL N 20181231 54973-2033_5f9dcedd-a227-bb1d-e053-2a91aa0a9d0c 54973-2033 HUMAN OTC DRUG CALC FLUOR calcium fluoride TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM FLUORIDE 6 [hp_X]/1 N 20181231 54973-2043_518cb8a5-4163-05e2-e054-00144ff88e88 54973-2043 HUMAN OTC DRUG CALC PHOS CALCIUM PHOSPHATE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM PHOSPHATE 6 [hp_X]/1 N 20181231 54973-2049_3901e4e5-f697-45c4-aa46-f1808100be7a 54973-2049 HUMAN OTC DRUG CALCIUM SULPHATE CALCIUM SULFATE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM SULFATE 6 [hp_X]/1 N 20181231 54973-2052_5563972b-6ea5-3c9d-e054-00144ff88e88 54973-2052 HUMAN OTC DRUG Calendula Off. Calendula Officinalis Flowering Top OINTMENT TOPICAL 19970217 UNAPPROVED HOMEOPATHIC Hyland's CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g N 20181231 54973-2202_56550bdc-b601-5b16-e054-00144ff8d46c 54973-2202 HUMAN OTC DRUG ClearAc BERBERIS VULGARIS ROOT BARK,ECHINACEA ANGUSTIFOLIA,CALCIUM SULFIDE and SULFUR IODIDE TABLET, SOLUBLE ORAL 19910901 UNAPPROVED HOMEOPATHIC Hyland's SULFUR IODIDE; BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE 12; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-2900_5f12e24c-f3b5-222f-e053-2a91aa0a33f4 54973-2900 HUMAN OTC DRUG ACONITE NAPELLIS aconitum napellus root TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS ROOT 30 [hp_X]/1 N 20181231 54973-2901_5f26703b-d841-6acf-e053-2991aa0a00d6 54973-2901 HUMAN OTC DRUG ALLIUM CEPA onion TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ONION 30 [hp_X]/1 N 20181231 54973-2902_5f35636d-379d-0ec9-e053-2991aa0ad7f5 54973-2902 HUMAN OTC DRUG ANTIMONIUM TART antimony potassium tartrate TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ANTIMONY POTASSIUM TARTRATE 30 [hp_X]/1 N 20181231 54973-2903_5f36132b-76aa-6ac5-e053-2a91aa0abacc 54973-2903 HUMAN OTC DRUG APIS MELLIFICA apis mellifera TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's APIS MELLIFERA 30 [hp_X]/1 N 20181231 54973-2904_5f375ed3-d1ae-bde4-e053-2a91aa0af96b 54973-2904 HUMAN OTC DRUG ARNICA MONTANA arnica montana TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA 30 [hp_X]/1 N 20181231 54973-2905_5f3b6436-0a2f-21ee-e053-2a91aa0a0a39 54973-2905 HUMAN OTC DRUG ARSENICUM ALBUM arsenic trioxide TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ARSENIC TRIOXIDE 30 [hp_X]/1 N 20181231 54973-2906_5f3c477b-76b5-78a1-e053-2a91aa0a1afe 54973-2906 HUMAN OTC DRUG BELLADONNA atropa belladonna root TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ATROPA BELLADONNA ROOT 30 [hp_X]/1 N 20181231 54973-2907_5f9bac14-678f-f33c-e053-2a91aa0a4937 54973-2907 HUMAN OTC DRUG BRYONIA ALBA bryonia alba root TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT 30 [hp_X]/1 N 20181231 54973-2909_5f9fb9e8-55fd-5e47-e053-2991aa0a0d86 54973-2909 HUMAN OTC DRUG CANTHARIS lytta vesicatoria TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's LYTTA VESICATORIA 30 [hp_X]/1 N 20181231 54973-2910_5fa04ea2-4bde-e178-e053-2a91aa0af848 54973-2910 HUMAN OTC DRUG CARBO VEG activated charcoal TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's ACTIVATED CHARCOAL 30 [hp_X]/1 N 20181231 54973-2911_5100b49e-ac1f-4651-e054-00144ff8d46c 54973-2911 HUMAN OTC DRUG CHAMOMILLA matricaria chamomilla flowering top oil TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's MATRICARIA CHAMOMILLA FLOWERING TOP OIL 30 [hp_X]/1 N 20181231 54973-2913_60b8890f-559d-aef6-e053-2991aa0ae886 54973-2913 HUMAN OTC DRUG GELSEMIUM SEMP gelsemium sempervirens root TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's GELSEMIUM SEMPERVIRENS ROOT 30 [hp_X]/1 N 20181231 54973-2914_602ae71d-3d3b-eb11-e053-2991aa0a45b7 54973-2914 HUMAN OTC DRUG HEPAR SULPH. CALC. calcium sulfide TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM SULFIDE 30 [hp_X]/1 N 20181231 54973-2915_603bc000-a1b7-d77a-e053-2a91aa0aaf8d 54973-2915 HUMAN OTC DRUG HYPERICUM PERF hypericum perforatum TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's HYPERICUM PERFORATUM 30 [hp_X]/1 N 20181231 54973-2916_603daf45-4036-350a-e053-2991aa0ac98c 54973-2916 HUMAN OTC DRUG IGNATIA AMARA strychnos ignatii seed TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's STRYCHNOS IGNATII SEED 30 [hp_X]/1 N 20181231 54973-2917_603df544-ca4d-9c90-e053-2a91aa0acab2 54973-2917 HUMAN OTC DRUG IPECACUANHA ipecac TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's IPECAC 30 [hp_X]/1 N 20181231 54973-2918_6050143b-dedf-65eb-e053-2a91aa0ad999 54973-2918 HUMAN OTC DRUG LEDUM PAL ledum palustre twig TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's LEDUM PALUSTRE TWIG 30 [hp_X]/1 N 20181231 54973-2920_6050e11f-c83f-7b90-e053-2a91aa0af30e 54973-2920 HUMAN OTC DRUG MERCURIUS VIVUS mercurius solubilis TABLET ORAL 19950101 UNAPPROVED HOMEOPATHIC Hyland's MERCURIUS SOLUBILIS 30 [hp_X]/1 N 20181231 54973-2921_6077c4c1-a395-7a7a-e053-2a91aa0a8a67 54973-2921 HUMAN OTC DRUG NUX VOMICA strychnos nux-vomica seed TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's STRYCHNOS NUX-VOMICA SEED 30 [hp_X]/1 N 20181231 54973-2923_6078598c-1204-23f0-e053-2a91aa0af046 54973-2923 HUMAN OTC DRUG PULSATILLA NIG pulsatilla vulgaris TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's PULSATILLA VULGARIS 30 [hp_X]/1 N 20181231 54973-2924_6079d45c-dd3c-6f2e-e053-2991aa0a9743 54973-2924 HUMAN OTC DRUG RHUS TOX toxicodendron radicans leaf TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's TOXICODENDRON RADICANS LEAF 30 [hp_X]/1 N 20181231 54973-2925_6079ec2b-d534-274a-e053-2a91aa0a57b2 54973-2925 HUMAN OTC DRUG RUTA GRAV ruta graveolens flowering top TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's RUTA GRAVEOLENS FLOWERING TOP 30 [hp_X]/1 N 20181231 54973-2926_60a47db8-f4d0-1d4c-e053-2a91aa0a4469 54973-2926 HUMAN OTC DRUG SPONGIA TOSTA spongia officinalis skeleton, roasted TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_X]/1 N 20181231 54973-2927_9aa89d09-c7c3-490b-b7f1-9e20f23a74f2 54973-2927 HUMAN OTC DRUG SULPHUR SULFUR TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's SULFUR 30 [hp_X]/1 N 20181231 54973-2928_9313b96f-bc5c-4c03-b08b-ba4b67062858 54973-2928 HUMAN OTC DRUG VERATRUM ALBUM VERATRUM ALBUM ROOT TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's VERATRUM ALBUM ROOT 30 [hp_X]/1 N 20181231 54973-2932_6077c4c1-a3c4-7a7a-e053-2a91aa0a8a67 54973-2932 HUMAN OTC DRUG PHOSPHORUS phosphorus TABLET ORAL 19550101 UNAPPROVED HOMEOPATHIC Hyland's PHOSPHORUS 30 [hp_X]/1 N 20181231 54973-2955_5feda8ac-05f7-36b2-e053-2a91aa0a2cbd 54973-2955 HUMAN OTC DRUG ARTHRITIS PAIN FORMULA arnica montana, black cohosh, guaiacum officinale resin, bryonia alba root, and toxicodendron pubescens leaf TABLET, SOLUBLE ORAL 19940525 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA; BLACK COHOSH; GUAIACUM OFFICINALE RESIN; BRYONIA ALBA ROOT; TOXICODENDRON PUBESCENS LEAF 6; 3; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-2956_5efe5fb6-a7d5-17cf-e053-2991aa0a31a2 54973-2956 HUMAN OTC DRUG LEG CRAMPS cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top TABLET, SOLUBLE ORAL 19951204 UNAPPROVED HOMEOPATHIC Hyland's CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 3; 6; 3; 6; 6; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-2957_88058e53-480a-4a8f-9361-043f95eb26c5 54973-2957 HUMAN OTC DRUG PMS VIBURNUM OPULUS BARK, CAULOPHYLLUM THALICTROIDES ROOT, ANAMIRTA COCCULUS SEED, and GELSEMIUM SEMPERVIRENS ROOT TABLET, SOLUBLE ORAL 19970926 UNAPPROVED HOMEOPATHIC Hyland's VIBURNUM OPULUS BARK; CAULOPHYLLUM THALICTROIDES ROOT; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT 2; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-2961_602dd304-7575-3875-e053-2991aa0ab369 54973-2961 HUMAN OTC DRUG Menstrual Cramps magnesium phosphate, dibasic trihydrate, citrullus colocynthis fruit pulp, black cohosh, and pulsatilla vulgaris TABLET, SOLUBLE ORAL 19950418 UNAPPROVED HOMEOPATHIC Hyland's MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; CITRULLUS COLOCYNTHIS FRUIT PULP; BLACK COHOSH; PULSATILLA VULGARIS 12; 12; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-2965_3b137558-9b90-4cfb-8f42-88046ddbb982 54973-2965 HUMAN OTC DRUG BACKACHE WITH ARNICA BENZOIC ACID, COLCHICUM AUTUMNALE BULB, SULFUR, ARNICA MONTANA, and TOXICODENDRON PUBESCENS LEAF TABLET, SOLUBLE ORAL 19990515 UNAPPROVED HOMEOPATHIC Hyland's BENZOIC ACID; COLCHICUM AUTUMNALE BULB; SULFUR; ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3010_60c87af2-1dba-2daf-e053-2a91aa0a7555 54973-3010 HUMAN OTC DRUG COLD Aconitum Napellus, Allium Cepa, Gelsemium Semp., Zincum Gluconicum TABLET ORAL 19970217 UNAPPROVED HOMEOPATHIC Hylands ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; ONION; ZINC GLUCONATE 6; 6; 6; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-3012_5bc463ad-e0da-6c14-e053-2a91aa0a3871 54973-3012 HUMAN OTC DRUG Seasonal Allergy Relief onion, sodium chloride, histamine dihydrochloride, cucumber, galphimia glauca flowering top, and strychnos nux-vomica seed TABLET, SOLUBLE ORAL 20020529 UNAPPROVED HOMEOPATHIC Hyland's ONION; SODIUM CHLORIDE; HISTAMINE DIHYDROCHLORIDE; CUCUMBER; GALPHIMIA GLAUCA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED 6; 6; 12; 12; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3013_602e3638-e02e-af5b-e053-2a91aa0aa419 54973-3013 HUMAN OTC DRUG Migraine Headache Relief nitroglycerin, atropa belladonna, gelsemium sempervirens root, strychnos nux-vomica seed, iris versicolor root, and sanguinaria canadensis root TABLET, SOLUBLE ORAL 19991011 UNAPPROVED HOMEOPATHIC Hyland's NITROGLYCERIN; ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; IRIS VERSICOLOR ROOT; SANGUINARIA CANADENSIS ROOT 12; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3014_6065e359-c1f2-4768-e053-2a91aa0ab884 54973-3014 HUMAN OTC DRUG NERVE TONIC calcium phosphate, iron, potassium phosphate, unspecified form, magnesium phosphate, dibasic trihydrate, and sodium phosphate TABLET ORAL 19700101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM PHOSPHATE, UNSPECIFIED FORM; IRON; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3075_7801c249-513d-4b6e-9168-3c10d1ac7f84 54973-3075 HUMAN OTC DRUG Cold n Cough 4 Kids ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, and GOLDENSEAL LIQUID ORAL 20080801 UNAPPROVED HOMEOPATHIC HYLAND'S, INC. ONION; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR; GOLDENSEAL 6; 12; 6; 12; 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3084_53acb8f4-1377-409d-e054-00144ff8d46c 54973-3084 HUMAN OTC DRUG ARNICA arnica montana TABLET, SOLUBLE ORAL 20081217 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA 30 [hp_X]/1 N 20181231 54973-3085_6051275f-e5fe-68d5-e053-2991aa0a3c1f 54973-3085 HUMAN OTC DRUG MUSCLE THERAPY WITH ARNICA arnica montana, bellis perennis, hypericum perforatum, ledum palustre twig, and ruta graveolens flowering top GEL TOPICAL 20090115 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP 2; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-3093_604198fc-2295-b19f-e053-2991aa0a3021 54973-3093 HUMAN OTC DRUG Leg Cramps PM oyster shell calcium carbonate, crude, causticum, matricaria recutita, cinchona officinalis bark, copper, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, silicon dioxide, and sulfur TABLET, SOLUBLE ORAL 20100101 UNAPPROVED HOMEOPATHIC Hyland's OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COPPER; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR 12; 12; 6; 3; 12; 12; 6; 6; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3097_5f238bc5-30a7-e739-e053-2a91aa0a447e 54973-3097 HUMAN OTC DRUG Complete Allergy 4 Kids aconitum napellus, onion, euphrasia stricta, galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, sodium chloride, strychnos nux-vomica seed, pulsatilla vulgaris, and schoenocaulon officinale seed LIQUID ORAL 20100701 UNAPPROVED HOMEOPATHIC Hyland's, Inc. ACONITUM NAPELLUS; ONION; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED 6; 6; 6; 12; 12; 12; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3098_5fb32eff-0efc-606a-e053-2a91aa0a378e 54973-3098 HUMAN OTC DRUG Nighttime Cold n Cough 4 Kids onion, coffee bean, chamomile, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, and sulfur LIQUID ORAL 20100701 UNAPPROVED HOMEOPATHIC Hyland's SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR; ONION; COFFEE BEAN; CHAMOMILE; CALCIUM SULFIDE; GOLDENSEAL 6; 6; 12; 6; 12; 6; 6; 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3101_5f9c8c4e-5d1a-ecae-e053-2991aa0afe02 54973-3101 HUMAN OTC DRUG CALC FLUOR calcium fluoride TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM FLUORIDE 30 [hp_X]/1 N 20181231 54973-3102_518cb8a5-4150-05e2-e054-00144ff88e88 54973-3102 HUMAN OTC DRUG CALC PHOS CALCIUM PHOSPHATE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM PHOSPHATE 30 [hp_X]/1 N 20181231 54973-3103_087ed624-860b-46e4-ae23-2298c45a6ad2 54973-3103 HUMAN OTC DRUG CALCIUM SULPHATE CALCIUM SULFATE TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM SULFATE 30 [hp_X]/1 N 20181231 54973-3104_5fec8283-853e-3aff-e053-2a91aa0a71a3 54973-3104 HUMAN OTC DRUG FERRUM PHOSPHATE sodium phosphate TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM PHOSPHATE 30 [hp_X]/1 N 20181231 54973-3105_603f2137-98b6-9f24-e053-2a91aa0a90aa 54973-3105 HUMAN OTC DRUG KALI MURIATICUM potassium chloride TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM CHLORIDE 30 [hp_X]/1 N 20181231 54973-3106_603fdf4c-4668-7a9c-e053-2a91aa0a88e3 54973-3106 HUMAN OTC DRUG KALI PHOS potassium phosphate, unspecified form TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM PHOSPHATE, UNSPECIFIED FORM 30 [hp_X]/1 N 20181231 54973-3107_60403e9f-7e10-05cb-e053-2991aa0a64f2 54973-3107 HUMAN OTC DRUG KALI SULPH potassium sulfate TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM SULFATE 30 [hp_X]/1 N 20181231 54973-3108_6050300d-6dc1-1c63-e053-2991aa0ae57d 54973-3108 HUMAN OTC DRUG MAGNESIA PHOS magnesium phosphate, dibasic trihydrate TABLET ORAL 19600101 UNAPPROVED HOMEOPATHIC Hyland's MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 30 [hp_X]/1 N 20181231 54973-3109_60563246-98d8-8a96-e053-2a91aa0a4ec7 54973-3109 HUMAN OTC DRUG NATRUM MURIATICUM sodium chloride TABLET ORAL 19600101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM CHLORIDE 30 [hp_X]/1 N 20181231 54973-3110_60564eec-f95f-1120-e053-2991aa0a397d 54973-3110 HUMAN OTC DRUG NAT. PHOS. sodium phosphate, dibasic, anhydrous TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 30 [hp_X]/1 N 20181231 54973-3111_6063eb3d-72b1-d31a-e053-2a91aa0a9696 54973-3111 HUMAN OTC DRUG NAT SULPH sodium sulfate anhydrous TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM SULFATE ANHYDROUS 30 [hp_X]/1 N 20181231 54973-3112_6079d45c-dd66-6f2e-e053-2991aa0a9743 54973-3112 HUMAN OTC DRUG SILICEA silicon dioxide TABLET ORAL 19600101 UNAPPROVED HOMEOPATHIC Hyland's SILICON DIOXIDE 30 [hp_X]/1 N 20181231 54973-3114_602c246c-873d-bc57-e053-2a91aa0ae1bc 54973-3114 HUMAN OTC DRUG LEG CRAMPS cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top TABLET, SOLUBLE ORAL 19951204 UNAPPROVED HOMEOPATHIC Hyland's CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 3; 6; 3; 6; 6; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3122_54c6da67-f128-27fd-e054-00144ff88e88 54973-3122 HUMAN OTC DRUG BIOPLASMA SPORT WITH ELECTROLYTES calcium fluoride, tribasic calcium phosphate, calcium sulfate anhydrous, ferrosoferric phosphate, potassium chloride, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium chloride, sodium phosphate, dibasic, heptahydrate, sodium sulfate, and silicon dioxide POWDER ORAL 20110406 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SILICON DIOXIDE 6; 3; 3; 3; 3; 3; 3; 6; 3; 3; 6 [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g N 20181231 54973-3123_5fb2381b-893b-5168-e053-2991aa0af472 54973-3123 HUMAN OTC DRUG Defend Cold and Cough Night onion, coffee bean, chamomile, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, and sulfur LIQUID ORAL 20110617 UNAPPROVED HOMEOPATHIC Hyland's CHAMOMILE; CALCIUM SULFIDE; GOLDENSEAL; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; ONION; COFFEE BEAN 6; 12; 6; 6; 6; 12; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3124_60156bc0-20ee-1ac6-e053-2991aa0a1a33 54973-3124 HUMAN OTC DRUG Defend Cold and Cough onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal LIQUID ORAL 20110617 UNAPPROVED HOMEOPATHIC Hyland's ONION; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; GOLDENSEAL 6; 12; 6; 12; 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3134_55de479f-1216-4dc5-e054-00144ff88e88 54973-3134 HUMAN OTC DRUG DIARREX ARSENIC TRIOXIDE, PODOPHYLLUM, CHAMOMILE, PHOSPHORUS, and MERCURY TABLET ORAL 20120517 UNAPPROVED HOMEOPATHIC Hyland's ARSENIC TRIOXIDE; PODOPHYLLUM; CHAMOMILE; PHOSPHORUS; MERCURY 6; 6; 6; 6; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3147_544dfee7-43cb-6f28-e054-00144ff8d46c 54973-3147 HUMAN OTC DRUG BABY COLIC dioscorea villosa tuber, chamomile, and citrullus colocynthis fruit pulp TABLET, SOLUBLE ORAL 20121031 UNAPPROVED HOMEOPATHIC Hyland's DIOSCOREA VILLOSA TUBER; CHAMOMILE; CITRULLUS COLOCYNTHIS FRUIT PULP 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3154_3e4a6dda-9cbc-407b-818f-71c14f2fdfe7 54973-3154 HUMAN OTC DRUG Cough Baby IPECAC, BRYONIA ALBA ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, PHOSPHORUS, CAUSTICUM, DROSERA ROTUNDIFOLIA, and RUMEX CRISPUS ROOT SYRUP ORAL 20121017 UNAPPROVED HOMEOPATHIC Hyland's IPECAC; BRYONIA ALBA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; PHOSPHORUS; CAUSTICUM; DROSERA ROTUNDIFOLIA; RUMEX CRISPUS ROOT 6; 6; 6; 12; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3155_967e06c7-2660-4bfe-bc68-4736cd62b6ec 54973-3155 HUMAN OTC DRUG NERVE TONIC STRESS RELIEF CALCIUM PHOSPHATE, IRON, POTASSIUM PHOSPHATE, UNSPECIFIED FORM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and SODIUM PHOSPHATE TABLET ORAL 19700101 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM PHOSPHATE; IRON; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3156_518d60ed-583e-0cf9-e054-00144ff88e88 54973-3156 HUMAN OTC DRUG Defend Severe Cold and Flu aconitum napellus root, cairina moschata heart/liver autolysate, bryonia alba root, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide POWDER ORAL 20130401 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 6; 200; 6; 6; 6; 6; 6 [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3158_54899dc4-b489-2b10-e054-00144ff8d46c 54973-3158 HUMAN OTC DRUG Tiny Cold eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide TABLET, SOLUBLE ORAL 20111228 UNAPPROVED HOMEOPATHIC Hyland's EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3160_60a24966-6567-cc60-e053-2991aa0a0204 54973-3160 HUMAN OTC DRUG SNIFFLES N SNEEZES 4 KIDS aconitum napellus root, onion, gelsemium sempervirens root, and zinc gluconate TABLET ORAL 20130610 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS ROOT; ONION; GELSEMIUM SEMPERVIRENS ROOT; ZINC GLUCONATE 6; 6; 6; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3161_5feda8ac-0608-36b2-e053-2a91aa0a2cbd 54973-3161 HUMAN OTC DRUG CALM N RESTFUL 4 KIDS aconitum napellus root, calcium phosphate, chamomile, artemisia cina pre-flowering top, lycopodium clavatum spore, sodium chloride, pulsatilla vulgaris, and sulfur TABLET ORAL 20130610 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS ROOT; CALCIUM PHOSPHATE; CHAMOMILE; ARTEMISIA CINA PRE-FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PULSATILLA VULGARIS; SULFUR 6; 12; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3162_5bc218fb-afff-08ef-e053-2991aa0a01c2 54973-3162 HUMAN OTC DRUG Restful Legs arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc TABLET, SOLUBLE ORAL 20060717 UNAPPROVED HOMEOPATHIC Hyland's ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SULFUR; ZINC 12; 6; 6; 6; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3163_53a944f6-f69b-72fa-e054-00144ff8d46c 54973-3163 HUMAN OTC DRUG ALLERGY RELIEF 4 KIDS onion, galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, sodium chloride, and strychnos nux-vomica seed TABLET ORAL 20130610 UNAPPROVED HOMEOPATHIC Hyland's ONION; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 6; 12; 12; 12; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3169_56bdf20b-0a8b-4532-e054-00144ff8d46c 54973-3169 HUMAN OTC DRUG Earache MATRICARIA CHAMOMILLA, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SULFUR, PULSATILLA VULGARIS and LYCOPODIUM CLAVATUM SPORE TABLET ORAL 20130415 UNAPPROVED HOMEOPATHIC Hyland's MATRICARIA CHAMOMILLA; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SULFUR 30; 30; 30; 30; 30; 30 [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g N 20181231 54973-3172_60147071-5ca2-1e47-e053-2991aa0a2714 54973-3172 HUMAN OTC DRUG EARACHE DROPS belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur LIQUID AURICULAR (OTIC) 20040617 UNAPPROVED HOMEOPATHIC Hyland's BELLADONNA LEAF; CALCIUM CARBONATE; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; ANEMONE PATENS; SULFUR 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 54973-3174_5f502149-9000-295c-e053-2a91aa0a10f0 54973-3174 HUMAN OTC DRUG Baby Gas Drops silver nitrate, ferula sumbul root, activated charcoal, chamomile, cinchona officinalis bark, citrullus colocynthis fruit, lycopodium clavatum spore, nutmeg, and sepia officinalis juice LIQUID ORAL 20140115 UNAPPROVED HOMEOPATHIC Hyland's SILVER NITRATE; FERULA SUMBUL ROOT; ACTIVATED CHARCOAL; CHAMOMILE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT; LYCOPODIUM CLAVATUM SPORE; NUTMEG; SEPIA OFFICINALIS JUICE 12; 6; 12; 6; 6; 6; 30; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3177_55a3de43-3b76-6651-e054-00144ff88e88 54973-3177 HUMAN OTC DRUG 4 KIDS COLD N COUGH DAY AND NIGHT VALUE PACK onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, goldenseal, strychnos nux-vomica seed, coffee bean, and chamomile KIT 20131201 UNAPPROVED HOMEOPATHIC Hylands Inc. N 20181231 54973-3179_5fc6fb3d-25d7-6055-e053-2991aa0ac934 54973-3179 HUMAN OTC DRUG 4 Kids Complete Cold and Mucus bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide LIQUID ORAL 20140701 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; SILICON DIOXIDE 6; 6; 12; 30; 30; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3180_549efb5c-7383-28b8-e054-00144ff8d46c 54973-3180 HUMAN OTC DRUG Baby Nighttime Tiny Cold chamomile, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide LIQUID ORAL 20140701 UNAPPROVED HOMEOPATHIC Hyland's CHAMOMILE; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3183_89b70071-4853-4835-8d03-c05d69250b95 54973-3183 HUMAN OTC DRUG Defend Cold and Mucus BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, and SILICON DIOXIDE LIQUID ORAL 20140701 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PATENS; RUMEX CRISPUS ROOT; SILICON DIOXIDE 6; 6; 12; 30; 30; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3185_f5c64dcf-82cf-481e-a791-4133a677fe50 54973-3185 HUMAN OTC DRUG DEFEND Cough BRYONIA ALBA ROOT, CAUSTICUM, DROSERA ROTUNDIFOLIA, IPECAC, PHOSPHORUS, RUMEX CRISPUS ROOT, and SPONGIA OFFICINALIS SKELETON, ROASTED SYRUP ORAL 20140701 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT; CAUSTICUM; DROSERA ROTUNDIFOLIA; IPECAC; PHOSPHORUS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 6; 6; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3186_93cc94b2-f774-4da7-84f6-973b3f4416b9 54973-3186 HUMAN OTC DRUG 4 Kids Complete Cold and Flu ANAS PLATYRHYNCHOS FEATHER, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, and Potassium Iodide LIQUID ORAL 20140414 UNAPPROVED HOMEOPATHIC Hyland's ANAS PLATYRHYNCHOS FEATHER; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 200; 6; 6; 6; 6; 6 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3187_dc7bd318-ec85-4c30-8050-0302fc7c4d07 54973-3187 HUMAN OTC DRUG DEFEND Sinus OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, and PULSATILLA VULGARIS TABLET, SOLUBLE ORAL 20140701 UNAPPROVED HOMEOPATHIC Hyland's OYSTER SHELL CALCIUM CARBONATE, CRUDE; GOLDENSEAL; POTASSIUM DICHROMATE; PULSATILLA VULGARIS 3; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3188_5d563268-c697-4ae3-9edc-1eb9d30556e3 54973-3188 HUMAN OTC DRUG Sinus OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, and PULSATILLA VULGARIS TABLET ORAL 20140801 UNAPPROVED HOMEOPATHIC Hyland's OYSTER SHELL CALCIUM CARBONATE, CRUDE; GOLDENSEAL; POTASSIUM DICHROMATE; PULSATILLA VULGARIS 3; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3196_60a4e1b3-99c2-8e7f-e053-2a91aa0a769a 54973-3196 HUMAN OTC DRUG Tummy Ache 4Kids silver nitrate, asafetida, activated charcoal, matricaria recutita, cinchona officinalis bark, citrullus colocynthis fruit pulp, lycopodium clavatum spore, nutmeg, and pulsatilla vulgaris TABLET ORAL 20141020 UNAPPROVED HOMEOPATHIC Hyland's SILVER NITRATE; ASAFETIDA; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; NUTMEG; PULSATILLA VULGARIS 6; 6; 12; 6; 6; 6; 30; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3202_518e56d9-0d9a-360d-e054-00144ff88e88 54973-3202 HUMAN OTC DRUG Leg Cramps ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, and VISCUM ALBUM FRUITING TOP OINTMENT TOPICAL 20150512 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS; ARNICA MONTANA; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 3; 3; 3; 10; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-3204_dbbec874-4b1c-4588-b907-b9da73dea9f7 54973-3204 HUMAN OTC DRUG Traumex ACONITUM NAPELLUS, ARNICA MONTANA, ATROPA BELLADONNA, BELLIS PERENNIS, BRYONIA ALBA ROOT, CALENDULA OFFICINALIS FLOWERING TOP, BLACK COHOSH, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM, and TOXICODENDRON PUBESCENS LEAF OINTMENT TOPICAL 20150522 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; BLACK COHOSH; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; TOXICODENDRON PUBESCENS LEAF 3; 3; 6; 6; 3; 3; 6; 3; 3; 3; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-3206_82080ce0-b30b-4dd8-bf0b-536e81c83f61 54973-3206 HUMAN OTC DRUG Sleep HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, and POTASSIUM PHOSPHATE, DIBASIC TABLET ORAL 20141105 UNAPPROVED HOMEOPATHIC Hyland's HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC 6; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3207_5bad7327-044f-297e-e053-2a91aa0a0a04 54973-3207 HUMAN OTC DRUG Hemorrhoids CALCIUM FLUORIDE,STRYCHNOS NUX-VOMICA SEED,HORSE CHESTNUT and KRAMERIA LAPPACEA ROOT TABLET ORAL 20140807 UNAPPROVED HOMEOPATHIC Hyland's CALCIUM FLUORIDE; KRAMERIA LAPPACEA ROOT; HORSE CHESTNUT; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3210_5f9b87fd-1485-2cff-e053-2991aa0a16f8 54973-3210 HUMAN OTC DRUG 4KIDS BUMPS N BRUISES with ARNICA arnica montana, bellis perennis, hypericum perforatum, and ruta graveolens flowering top OINTMENT TOPICAL 20150528 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP 2; 6; 3; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-3211_60caec1c-9fc9-ed68-e053-2991aa0acd43 54973-3211 HUMAN OTC DRUG Sore Throat BARIUM CARBONATE, PHYTOLACCA AMERICANA ROOT, ATROPA BELLADONNA AND MERCURIC IODIDE TABLET ORAL 20150114 UNAPPROVED HOMEOPATHIC Hyland's MERCURIC IODIDE; PHYTOLACCA AMERICANA ROOT; ATROPA BELLADONNA; BARIUM CARBONATE 30; 6; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3216_5ceeb264-23e4-f9ae-e053-2991aa0aecef 54973-3216 HUMAN OTC DRUG Upset Stomach ACTIVATED CHARCOAL and STRYCHNOS NUX-VOMICA SEED TABLET ORAL 20150116 UNAPPROVED HOMEOPATHIC Hyland's ACTIVATED CHARCOAL; STRYCHNOS NUX-VOMICA SEED 3; 6 [hp_X]/1; [hp_X]/1 N 20181231 54973-3221_cf1813e3-aff7-417a-892c-798013f5233f 54973-3221 HUMAN OTC DRUG Complete FLU CARE CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, and POTASSIUM IODIDE TABLET, SOLUBLE ORAL 20151221 UNAPPROVED HOMEOPATHIC Hyland's CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 200; 6; 6; 6; 6; 3 [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3222_5d0320c8-f765-7be4-e053-2a91aa0a1466 54973-3222 HUMAN OTC DRUG Bronchial Cough POTASSIUM DICHROMATE,RUMEX CRISPUS ROOT and SANGUINARIA CANADENSIS ROOT TABLET ORAL 20150121 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM DICHROMATE; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3223_567fc4b2-15eb-429e-e054-00144ff88e88 54973-3223 HUMAN OTC DRUG EnurAid atropa belladonna, lytta vesicatoria, apis mellifera, arnica montana, onion, rhus aromatica root bark, and equisetum hyemale TABLET, SOLUBLE ORAL 19990101 UNAPPROVED HOMEOPATHIC Hyland's ATROPA BELLADONNA; LYTTA VESICATORIA; APIS MELLIFERA; ARNICA MONTANA; ONION; RHUS AROMATICA ROOT BARK; EQUISETUM HYEMALE 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3224_5bd53dc6-f04d-1b83-e053-2a91aa0a4796 54973-3224 HUMAN OTC DRUG Cold Sores and Fever Blisters ANTIMONY TRISULFIDE,BAPTISIA TINCTORIA ROOT,SODIUM BORATE and SODIUM CHLORIDE TABLET ORAL 20150206 UNAPPROVED HOMEOPATHIC Hyland's BAPTISIA TINCTORIA ROOT; SODIUM BORATE; ANTIMONY TRISULFIDE; SODIUM CHLORIDE 6; 3; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3225_57727985-da17-64b8-e053-2a91aa0a3411 54973-3225 HUMAN OTC DRUG Gas ASAFETIDA,STRYCHNOS IGNATII SEED,LYCOPODIUM CLAVATUM SPORE and NUTMEG TABLET ORAL 19970217 UNAPPROVED HOMEOPATHIC Hyland's LYCOPODIUM CLAVATUM SPORE; STRYCHNOS IGNATII SEED; ASAFETIDA; NUTMEG 6; 6; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-3228_57eb180e-88d2-27ea-e053-2a91aa0ad405 54973-3228 HUMAN OTC DRUG Headache atropa belladonna, gelsemium sempervirent root, ipecac and iris versicolor root TABLET, SOLUBLE ORAL 20150306 UNAPPROVED HOMEOPATHIC Hyland's ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; IPECAC 12; 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-3229_5bb0473b-0719-89f4-e053-2991aa0a7ccc 54973-3229 HUMAN OTC DRUG Indigestion POTASSIUM DICHROMATE,GOLDENSEAL,CINCHONA OFFICINALIS BARK and PHOSPHORIC ACID TABLET ORAL 20150401 UNAPPROVED HOMEOPATHIC Hyland's CINCHONA OFFICINALIS BARK; POTASSIUM DICHROMATE; PHOSPHORIC ACID; GOLDENSEAL 3; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3236_93701589-8def-4be8-9e3b-0290eaf74d8e 54973-3236 HUMAN OTC DRUG Good Morning POTASSIUM PHOSPHATE, DIBASIC, DAPHNE MEZEREUM BARK, SODIUM CHLORIDE, PHOSPHORIC ACID, SEPIA OFFICINALIS JUICE, DELPHINIUM STAPHISAGRIA SEED, SULFUR, and THUJA OCCIDENTALIS LEAFY TWIG TABLET ORAL 20151030 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM PHOSPHATE, DIBASIC; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 6; 12; 6; 6; 30; 30; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3241_6c97aece-a1b6-4950-a3f2-e2e03afab152 54973-3241 HUMAN OTC DRUG 4KIDS COMPLETE COLD N FLU CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, and POTASSIUM IODIDE TABLET ORAL 20151030 UNAPPROVED HOMEOPATHIC Hyland's CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 200; 6; 6; 6; 6; 3 [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3243_ca6dd94f-c58b-492b-a958-0e91c9469c92 54973-3243 HUMAN OTC DRUG 4 Kids Cold n Cough Grape Flavor ONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, and SULFUR LIQUID ORAL 20160210 UNAPPROVED HOMEOPATHIC Hyland's ONION; CALCIUM SULFIDE; GOLDENSEAL; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR 6; 12; 6; 6; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3245_5fb346ae-a31c-2099-e053-2a91aa0acb93 54973-3245 HUMAN OTC DRUG 4Kids Cold n Cough Nighttime Grape Flavor onion, matricaria recutita, arabica coffee bean, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, and sulfur LIQUID ORAL 20160418 UNAPPROVED HOMEOPATHIC Hyland's ONION; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; CALCIUM SULFIDE; GOLDENSEAL; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR 6; 6; 6; 12; 6; 6; 6; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3250_6026f2cc-e881-9e89-e053-2991aa0a449d 54973-3250 HUMAN OTC DRUG 4Kids Cold N Mucus Nighttime onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, rumex crispus root, silicon dioxide, and sulfur LIQUID ORAL 20160429 UNAPPROVED HOMEOPATHIC Hyland's ONION; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; EUPHRASIA STRICTA; CALCIUM SULFIDE; GOLDENSEAL; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; SILICON DIOXIDE; SULFUR 6; 6; 3; 3; 6; 12; 6; 6; 6; 30; 6; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3251_553e3574-24d1-1c0e-e054-00144ff8d46c 54973-3251 HUMAN OTC DRUG Baby Nighttime Mucus Cold Relief onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, rumex crispus root, silicon dioxide, and sulfur LIQUID ORAL 20151228 UNAPPROVED HOMEOPATHIC Hyland's ONION; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; EUPHRASIA STRICTA; CALCIUM SULFIDE; GOLDENSEAL; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; SILICON DIOXIDE; SULFUR 6; 6; 3; 3; 6; 12; 6; 6; 6; 30; 6; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3252_54b1d5b7-1510-3420-e054-00144ff8d46c 54973-3252 HUMAN OTC DRUG Baby Nighttime Tiny Cold matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide TABLET ORAL 20151228 UNAPPROVED HOMEOPATHIC Hyland's MATRICARIA RECUTITA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3257_5f9f0744-f288-a3c2-e053-2a91aa0a7536 54973-3257 HUMAN OTC DRUG CALMS FORTE avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower TABLET ORAL 20160429 UNAPPROVED HOMEOPATHIC Hyland's AVENA SATIVA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; HOPS; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PASSIFLORA INCARNATA FLOWER 4; 3; 4; 3; 4; 3; 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3274_5f9ed8a7-90dc-0fd6-e053-2991aa0ad919 54973-3274 HUMAN OTC DRUG CALMS FORTE avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower TABLET ORAL 20160429 UNAPPROVED HOMEOPATHIC Hyland's AVENA SATIVA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; HOPS; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PASSIFLORA INCARNATA FLOWER 4; 3; 4; 3; 4; 3; 3; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3282_161ac94c-480a-4164-ab95-e66bd921983f 54973-3282 HUMAN OTC DRUG 4 Kids Cold n Cough Day and Night Combo Pack ONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, SULFUR, MATRICARIA RECUTITA, ARABICA COFFEE BEAN, AND STRYCHNOS NUX-VOMICA SEED KIT 20160617 UNAPPROVED HOMEOPATHIC Hyland's N 20181231 54973-3283_eb8f4e9b-6d84-4674-879a-2f2518b29cc6 54973-3283 HUMAN OTC DRUG 4 Kids Cold n Cough ONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, and SULFUR LIQUID ORAL 20160513 UNAPPROVED HOMEOPATHIC Hyland's ONION; CALCIUM SULFIDE; GOLDENSEAL; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; SULFUR 6; 12; 6; 6; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3284_5f9a8a3e-533a-10b5-e053-2a91aa0a6cd6 54973-3284 HUMAN OTC DRUG BABY MUCUS AND COLD RELIEF bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide LIQUID ORAL 20160513 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT; EUPHRASIA STRICTA; CALCIUM SULFIDE; SODIUM CHLORIDE; PHOSPHORUS; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; SILICON DIOXIDE 6; 6; 12; 30; 30; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-3285_5fc40312-5fbf-dfed-e053-2a91aa0a17f4 54973-3285 HUMAN OTC DRUG 4 Kids Cold n Mucus Day and Night Value Pack bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, silicon dioxide, onion, matricaria recutita, arabica coffee bean, goldenseal, strychnos nux-vomica seed, anemone pulsatilla, and sulfur KIT 20160610 UNAPPROVED HOMEOPATHIC Hyland's N 20181231 54973-3307_d73ea3fb-3486-400e-8e1f-23b29a9701d6 54973-3307 HUMAN OTC DRUG Baby Tiny Cold Day and Night Value Pack eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, potassium iodide, and matricaria recutita KIT 20170111 UNAPPROVED HOMEOPATHIC Hyland's N 20181231 54973-3308_0633ab78-ea26-43e6-8db3-daf11d67dc92 54973-3308 HUMAN OTC DRUG BABY CALMING MATRICARIA RECUTITA, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PLATINUM, ANEMONE PULSATILLA, and SULFUR TABLET ORAL 20170120 UNAPPROVED HOMEOPATHIC Hyland's MATRICARIA RECUTITA; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PLATINUM; ANEMONE PULSATILLA; SULFUR 6; 6; 30; 30; 6; 30; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3313_67f9fd47-d143-4d40-b907-b15082b27078 54973-3313 HUMAN OTC DRUG Baby Mucus Cold Relief Day and Night Value Pack bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, silicon dioxide, onion, matricaria recutita, arabica coffee bean, goldenseal, strychnos nux-vomica seed, and sulfur KIT 20170330 UNAPPROVED HOMEOPATHIC Hyland's N 20181231 54973-3315_605427e6-7f85-0b7f-e053-2a91aa0a347c 54973-3315 HUMAN OTC DRUG Baby Oral Pain Relief oyster shell calcium carbonate, crude, tribasic calcium phosphate, arabica coffee bean, arnica montana, ferrum phosphoricum and matricaria chamomilla TABLET ORAL 20170817 UNAPPROVED HOMEOPATHIC HYLAND'S OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; ARABICA COFFEE BEAN; ARNICA MONTANA; MATRICARIA CHAMOMILLA; FERRUM PHOSPHORICUM 12; 12; 6; 30; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-3316_60546ebd-0f0c-1ef5-e053-2991aa0a0cab 54973-3316 HUMAN OTC DRUG 4 Kids Oral Pain Relief Oyster Shell Calcium Carbonate, Crude, Arabica Coffee Bean, Arnica Montana, Tribasic Calcium Phosphate, Ferrum Phosphoricum and Matricaria Chamomilla TABLET ORAL 20170818 UNAPPROVED HOMEOPATHIC Hyland's OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA; FERRUM PHOSPHORICUM 12; 6; 30; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-3324_60544029-9e3e-0db6-e053-2a91aa0afec7 54973-3324 HUMAN OTC DRUG Baby Nighttime Oral Pain Relief Arnica Montana, Tribasic Calcium Phosphate, Matricaria Chamomilla, Silicon Dioxide, Magnesium Phosphate, Dibasic Trihydrate, Ferrosoferric Phosphate, Arabica Coffee Bean and Oyster Shell Calcium Carbonate, Crude TABLET ORAL 20170817 UNAPPROVED HOMEOPATHIC HYLAND'S OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA; SILICON DIOXIDE; ARNICA MONTANA; FERROSOFERRIC PHOSPHATE; ARABICA COFFEE BEAN; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12; 12; 12; 12; 30; 12; 6; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-3325_60547caf-28b2-6d55-e053-2a91aa0af076 54973-3325 HUMAN OTC DRUG 4 Kids Oral Pain Relief Nighttime arnica montana,tribasic calcium phosphate,silicon dioxide,matricaria chamomilla,ferrum phosphoricum,arabica coffee bean,magnesium phosphate, dibasic trihydrate and oyster shell calcium carbonate, crude TABLET ORAL 20170818 UNAPPROVED HOMEOPATHIC Hyland's OYSTER SHELL CALCIUM CARBONATE, CRUDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ARABICA COFFEE BEAN; FERRUM PHOSPHORICUM; SILICON DIOXIDE; ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA 12; 12; 6; 12; 12; 30; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-3326_4fbde72f-86f7-062f-e054-00144ff88e88 54973-3326 HUMAN OTC DRUG 4 Kids Cold n Cough Day and Night Value Pack 4 Kids Cold n Cough Day and Night Value Pack KIT ORAL 20170519 UNAPPROVED HOMEOPATHIC Hyland's N 20181231 54973-3327_54399c3c-2fa4-327d-e054-00144ff8d46c 54973-3327 HUMAN OTC DRUG Arnica Montana arnica montana OINTMENT TOPICAL 19970217 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA 1 [hp_X]/g N 20181231 54973-3331_5e86783c-4155-5f46-e053-2991aa0abb3b 54973-3331 HUMAN OTC DRUG Calm TRIBASIC CALCIUM PHOSPHATE,FERROSOFERRIC PHOSPHATE,DIBASIC POTASSIUM PHOSPHATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE TABLET ORAL 20171204 UNAPPROVED HOMEOPATHIC Hyland's TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3; 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3332_5e9924be-4dae-324a-e053-2a91aa0a8ec1 54973-3332 HUMAN OTC DRUG Rest SILVER NITRATE,CAUSTICUM,MATRICARIA CHAMOMILLA,ANAMIRTA COCCULUS SEED,SODIUM CHLORIDE,PHOSPHORUS and VALERIAN TABLET ORAL 20171130 UNAPPROVED HOMEOPATHIC Hyland's ANAMIRTA COCCULUS SEED; CAUSTICUM; VALERIAN; SILVER NITRATE; MATRICARIA CHAMOMILLA; SODIUM CHLORIDE; PHOSPHORUS 12; 6; 6; 6; 3; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3333_5e8295ee-5d88-09e4-e053-2991aa0a619e 54973-3333 HUMAN OTC DRUG Awaken DAPHNE MEZEREUM BARK,SULFUR,DELPHINIUM STAPHISAGRIA SEED,SEPIA OFFICINALIS JUICE,SODIUM CHLORIDE,PHOSPHORIC ACID,DIBASIC POTASSIUM PHOSPHATE and THUJA OCCIDENTALIS LEAFY TWIG TABLET ORAL 20171201 UNAPPROVED HOMEOPATHIC Hyland's DELPHINIUM STAPHISAGRIA SEED; SEPIA OFFICINALIS JUICE; SODIUM CHLORIDE; DAPHNE MEZEREUM BARK; DIBASIC POTASSIUM PHOSPHATE; THUJA OCCIDENTALIS LEAFY TWIG; SULFUR; PHOSPHORIC ACID 30; 30; 6; 12; 6; 30; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3342_5b5cb641-2350-76b5-e053-2991aa0abbcd 54973-3342 HUMAN OTC DRUG 4 Kids Canker Sore Soothing Dots SILVER NITRATE,ECHINACEA, UNSPECIFIED and POTASSIUM CHLORIDE TABLET ORAL 20170821 UNAPPROVED HOMEOPATHIC Hyland's SILVER NITRATE; ECHINACEA, UNSPECIFIED; POTASSIUM CHLORIDE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3343_5928225b-c63d-acff-e053-2991aa0ae653 54973-3343 HUMAN OTC DRUG CANKER SORE HEALING DOTS Sodium Borate, Calendula Officinalis Flowering Top, Causticum, Daphne Mezereum Bark and Sodium Chloride TABLET ORAL 20170817 UNAPPROVED HOMEOPATHIC Hyland's DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; SODIUM BORATE; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM 12; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-3347_642ce868-c89e-7851-e053-2991aa0a6e06 54973-3347 HUMAN OTC DRUG Chamomilla MATRICARIA CHAMOMILLA TABLET ORAL 20180202 UNAPPROVED HOMEOPATHIC Hyland's MATRICARIA CHAMOMILLA 6 [hp_X]/1 N 20191231 54973-3348_641a1680-b672-73fb-e053-2a91aa0a208f 54973-3348 HUMAN OTC DRUG Baby Bumps Buises Arnica ARNICA MONTANA TABLET ORAL 20180202 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA 6 [hp_X]/1 N 20191231 54973-3431_5fec2489-6729-1e4f-e053-2991aa0a5a8e 54973-3431 HUMAN OTC DRUG FERRUM PHOSPHATE sodium phosphate TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM PHOSPHATE 6 [hp_X]/1 N 20181231 54973-5224_603fa445-ab7d-3929-e053-2a91aa0afb47 54973-5224 HUMAN OTC DRUG KALI MURIATICUM potassium chloride TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM CHLORIDE 6 [hp_X]/1 N 20181231 54973-5228_60400c64-91d9-12d9-e053-2991aa0a00dd 54973-5228 HUMAN OTC DRUG KALI PHOS potassium phosphate, unspecified form TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM PHOSPHATE, UNSPECIFIED FORM 6 [hp_X]/1 N 20181231 54973-5230_604147ed-8347-386e-e053-2a91aa0a0c42 54973-5230 HUMAN OTC DRUG KALI SULPH potassium sulfate TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's POTASSIUM SULFATE 6 [hp_X]/1 N 20181231 54973-6020_605088a3-b108-facf-e053-2a91aa0ab97b 54973-6020 HUMAN OTC DRUG MAGNESIA PHOS magnesium phosphate, dibasic trihydrate TABLET ORAL 19600101 UNAPPROVED HOMEOPATHIC Hyland's MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X]/1 N 20181231 54973-6433_6055dd6c-889e-3450-e053-2a91aa0a647f 54973-6433 HUMAN OTC DRUG NATRUM MURIATICUM sodium chloride TABLET ORAL 19600101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM CHLORIDE 6 [hp_X]/1 N 20181231 54973-6436_60567ff0-af5a-5c46-e053-2991aa0a7fc7 54973-6436 HUMAN OTC DRUG NAT. PHOS. sodium phosphate, dibasic, anhydrous TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 6 [hp_X]/1 N 20181231 54973-6440_6064b662-4dc1-39f1-e053-2a91aa0a4d59 54973-6440 HUMAN OTC DRUG NAT SULPH sodium sulfate anhydrous TABLET ORAL 19400101 UNAPPROVED HOMEOPATHIC Hyland's SODIUM SULFATE ANHYDROUS 6 [hp_X]/1 N 20181231 54973-7508_5552b5bf-3027-37d3-e054-00144ff88e88 54973-7508 HUMAN OTC DRUG Bumps n Bruises with Arnica arnica montana, hypericum perforatum, bellis perennis, and ruta graveolens flowering top TABLET, SOLUBLE ORAL 20061214 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA; HYPERICUM PERFORATUM; BELLIS PERENNIS; RUTA GRAVEOLENS FLOWERING TOP 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-7509_55ddafc3-41f8-3566-e054-00144ff88e88 54973-7509 HUMAN OTC DRUG BABY DIAPER CALENDULA OFFICINALIS FLOWER OINTMENT TOPICAL 20010101 UNAPPROVED HOMEOPATHIC Hyland's CALENDULA OFFICINALIS FLOWER 1 [hp_X]/g N 20181231 54973-7510_ed71fd35-9505-4f1e-a807-ebf844245919 54973-7510 HUMAN OTC DRUG BUMPS N BRUISES ARNICA MONTANA ROOT OINTMENT TOPICAL 20011018 UNAPPROVED HOMEOPATHIC Hyland's ARNICA MONTANA ROOT 1 [hp_X]/8g N 20181231 54973-7511_4a66c98f-32c0-49e9-a1bf-29754e0cff1d 54973-7511 HUMAN OTC DRUG Bug Bite APIS MELLIFERA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA ROOT, LEDUM PALUSTRE TWIG, and URTICA DIOICA OINTMENT TOPICAL 19900101 UNAPPROVED HOMEOPATHIC Hyland's APIS MELLIFERA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA ROOT; LEDUM PALUSTRE TWIG; URTICA DIOICA 3; 3; 3; 3; 3 [hp_X]/8g; [hp_X]/8g; [hp_X]/8g; [hp_X]/8g; [hp_X]/8g N 20181231 54973-7514_91bda183-589d-4deb-b1b0-cfb41a3dee2b 54973-7514 HUMAN OTC DRUG Leg Cramps ACONITUM NAPELLUS, ARNICA MONTANA, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, and VISCUM ALBUM FRUITING TOP OINTMENT TOPICAL 20030918 UNAPPROVED HOMEOPATHIC Hyland's ACONITUM NAPELLUS; ARNICA MONTANA; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 3; 3; 3; 10; 6; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 54973-7516_5feb7cc1-f114-7b04-e053-2a91aa0a3bd1 54973-7516 HUMAN OTC DRUG BABY INFANT EARACHE DROPS belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur LIQUID AURICULAR (OTIC) 20040316 UNAPPROVED HOMEOPATHIC Hyland's BELLADONNA LEAF; CALCIUM CARBONATE; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; ANEMONE PATENS; SULFUR 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 54973-7520_5fc8f4ab-1462-32b2-e053-2a91aa0a1445 54973-7520 HUMAN OTC DRUG Cough with 100% Natural Honey 4 Kids ipecac, aconitum napellus, spongia officinalis skeleton, roasted, and antimony potassium tartrate SYRUP ORAL 20080801 UNAPPROVED HOMEOPATHIC Hylands Inc. IPECAC; ACONITUM NAPELLUS; SPONGIA OFFICINALIS SKELETON, ROASTED; ANTIMONY POTASSIUM TARTRATE 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 54973-8081_60a01a76-0463-75e3-e053-2a91aa0ad385 54973-8081 HUMAN OTC DRUG SILICEA silicon dioxide TABLET ORAL 19600101 UNAPPROVED HOMEOPATHIC Hyland's SILICON DIOXIDE 6 [hp_X]/1 N 20181231 54973-9045_60ba27e2-17af-6d16-e053-2a91aa0ae73e 54973-9045 HUMAN OTC DRUG Thuja 1x THUJA OCCIDENTALIS LEAFY TWIG OINTMENT TOPICAL 19970217 UNAPPROVED HOMEOPATHIC Hyland's THUJA OCCIDENTALIS LEAFY TWIG 1 [hp_X]/1 N 20181231 54973-9104_ddaac1e1-a325-4717-b5e6-40f4f8ad5d8a 54973-9104 HUMAN OTC DRUG Cough BRYONIA ALBA ROOT, CAUSTICUM, CALCIUM SULFIDE, and ANTIMONY POTASSIUM TARTRATE TABLET, SOLUBLE ORAL 19940809 UNAPPROVED HOMEOPATHIC Hyland's BRYONIA ALBA ROOT; CAUSTICUM; CALCIUM SULFIDE; ANTIMONY POTASSIUM TARTRATE 3; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-9113_602dd304-758b-3875-e053-2991aa0ab369 54973-9113 HUMAN OTC DRUG Menopause amyl nitrite, sanguinaria canadensis root, and lachesis muta venom TABLET, SOLUBLE ORAL 19950301 UNAPPROVED HOMEOPATHIC Hyland's AMYL NITRITE; SANGUINARIA CANADENSIS ROOT; LACHESIS MUTA VENOM 6; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-9138_602b1755-96f3-7781-e053-2a91aa0ad854 54973-9138 HUMAN OTC DRUG Hayfever ambrosia artemisiifolia, euphrasia stricta, onion, and schoenocaulon officinale seed TABLET, SOLUBLE ORAL 19970527 UNAPPROVED HOMEOPATHIC Hyland's AMBROSIA ARTEMISIIFOLIA; EUPHRASIA STRICTA; ONION; SCHOENOCAULON OFFICINALE SEED 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-9146_602ba903-e3f3-4f51-e053-2a91aa0a7bdf 54973-9146 HUMAN OTC DRUG Hives apis mellifera, urtica urens, sodium chloride, and arsenic trioxide TABLET, SOLUBLE ORAL 19970527 UNAPPROVED HOMEOPATHIC Hyland's APIS MELLIFERA; URTICA URENS; SODIUM CHLORIDE; ARSENIC TRIOXIDE 3; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54973-9147_6051cc96-86e3-bd0b-e053-2a91aa0a5dcf 54973-9147 HUMAN OTC DRUG Motion Sickness strychnos nux-vomica seed, tobacco leaf, kerosene, and anamirta cocculus seed TABLET, SOLUBLE ORAL 19941201 UNAPPROVED HOMEOPATHIC Hyland's STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; KEROSENE; ANAMIRTA COCCULUS SEED 6; 6; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 54982-0001_d3f2cd42-a1b6-4f65-998e-b934fdd5ac20 54982-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020125 UNAPPROVED MEDICAL GAS RTA Homecare, Inc. OXYGEN 99 L/100L E 20171231 54997-186_3c014861-e33c-4969-861e-a38204b89ab8 54997-186 HUMAN OTC DRUG 4Life Enummi Protective Day Moisturizer SPF-15 Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20070801 OTC MONOGRAPH NOT FINAL part352 4Life Research USA, LLC OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 2; 3 g/100mL; g/100mL; g/100mL N 20181231 55037-101_92e2932a-26c1-439a-b2e9-40679613972b 55037-101 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870101 NDA NDA205889 Matheson Tri-Gas, Inc. OXYGEN 992 1/L N 20181231 55037-201_5a3e4d14-3c12-43e5-a4fc-71c41dad4476 55037-201 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19870101 NDA NDA205891 Matheson Tri-Gas, Inc. NITROGEN 992 mL/L N 20181231 55037-301_60b3d911-c9f7-1032-e053-2a91aa0a6fd1 55037-301 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19870101 NDA NDA206009 Matheson Tri-Gas, Inc. NITROUS OXIDE 992 mL/L N 20181231 55037-302_bcd7d027-9c3f-4881-a553-739e3340d33d 55037-302 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19870101 NDA NDA205890 Matheson Tri-Gas, Inc. AIR 1000 mL/L N 20181231 55037-401_7ab815be-4bce-4ec9-a740-7bed55714573 55037-401 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19870101 NDA NDA205846 Matheson Tri-Gas, Inc. CARBON DIOXIDE 992 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 55037-501_00511221-2d04-437c-b85c-6817fdb0a93d 55037-501 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19870101 NDA NDA205843 Matheson Tri-Gas, Inc. HELIUM 992 mL/L N 20181231 55038-001_f5787162-37cb-425b-bcf1-10d2837ee6e4 55038-001 HUMAN OTC DRUG POMADA DRAGON PAIN RELIEVING CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20120731 OTC MONOGRAPH NOT FINAL part348 TELEVISA CONSUMER PRODUCTS USA CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g N 20181231 55038-002_c67a0356-7f0e-4060-8c7f-8db6df7a8a36 55038-002 HUMAN OTC DRUG OPTICAL ADVANCED EYE DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL SOLUTION/ DROPS OPHTHALMIC 20121031 OTC MONOGRAPH FINAL part349 TELEVISA CONSUMER PRODUCTS USA DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55038-023_5c818ba9-0c7a-45c4-8891-d3f4f565f6f6 55038-023 HUMAN OTC DRUG OPTICAL ORIGINAL EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20121031 OTC MONOGRAPH FINAL part349 TELEVISA CONSUMER PRODUCTS USA TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 55045-1147_cca757b4-55c2-4d0f-b578-e4d658c6db2f 55045-1147 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate gentamicin sulfate CREAM TOPICAL 19840705 ANDA ANDA062531 Dispensing Solutions, Inc. GENTAMICIN SULFATE 1 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 55045-1167_37aaa55b-70dd-43fe-b026-757c8f8c3fdb 55045-1167 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Dispensing Solutions, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 55045-1173_65fc9178-778e-43b0-9ef0-471dec4d16e1 55045-1173 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Dispensing Solutions, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 55045-1194_07080003-b495-447a-bb9d-0efbe866e37a 55045-1194 HUMAN PRESCRIPTION DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN neomycin sulfate, polymyxin b sulfate and gramicidin SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064047 Dispensing Solutions, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN 1.75; 10000; .025 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 55045-1243_e0f01554-43e3-4ed2-afef-d9fa4f539e54 55045-1243 HUMAN PRESCRIPTION DRUG acetic acid acetic acid SOLUTION AURICULAR (OTIC) 20100122 NDA NDA012179 Dispensing Solutions, Inc. ACETIC ACID 20.65 mg/mL E 20171231 55045-1259_93aefabb-b384-40ef-9d3f-f8dee3b21f1c 55045-1259 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 19981222 ANDA ANDA040183 Dispensing Solutions, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 55045-1266_e3562eaf-3ea6-4b11-903d-43479c7a1f1a 55045-1266 HUMAN PRESCRIPTION DRUG Promethazine VC With Codeine Codeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride SYRUP ORAL 20061207 ANDA ANDA040660 Dispensing Solutions, Inc. CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 10; 6.5; 5 mg/5mL; mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] CV E 20171231 55045-1350_ed20915d-9b52-41e3-9ecd-8ebe6073c149 55045-1350 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 Dispensing Solutions, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 55045-1433_667d0cdd-ff0b-45fa-a089-d7f563bbbda8 55045-1433 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Dispensing Solutions, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV E 20171231 55045-1580_916a131e-f470-4b42-b99d-9fb42e777a96 55045-1580 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Dispensing Solutions, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 CIII E 20171231 55045-1594_d223d18e-6d76-4a00-8c63-6ee0be2110bc 55045-1594 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110116 ANDA ANDA089895 Dispensing Solutions, Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 55045-1643_a720b953-0e63-4338-9a7f-ecf7b2784446 55045-1643 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 20060426 ANDA ANDA040643 Dispensing Solutions, Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 55045-1715_1531bc94-6955-4325-b76d-c8fbeeab70a3 55045-1715 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071523 Dispensing Solutions, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 55045-1755_25095d93-158f-4fe1-972d-db7f8bc6d6e1 55045-1755 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION OPHTHALMIC 20040701 ANDA ANDA088771 Dispensing Solutions, Inc. DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 55045-2092_7ebf0c69-ebc7-4ec0-a6c7-6b64880add9d 55045-2092 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20110504 ANDA ANDA086030 Dispensing Solutions, Inc. TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 55045-2386_a2bee0b5-a65e-4b4a-abce-60425cef53cc 55045-2386 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960222 ANDA ANDA040143 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 650 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 55045-2759_6493c29c-1bba-4172-badb-ea5cb3d9e727 55045-2759 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate CAPSULE ORAL 19991027 NDA NDA021087 Dispensing Solutions, Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] E 20171231 55045-2992_f3071984-c98d-464e-9211-08ac1600970e 55045-2992 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20090601 ANDA ANDA065334 Dispensing Solutions Inc. AMOXICILLIN 400 mg/5mL E 20171231 55045-3143_20baf571-544d-4945-b3dc-b905a54ec7bd 55045-3143 HUMAN OTC DRUG MUCINEX GUAIFENESIN TABLET, EXTENDED RELEASE ORAL 20100512 NDA NDA021282 Dispensing Solutions, Inc. GUAIFENESIN 600 mg/1 E 20171231 55045-3198_6493c29c-1bba-4172-badb-ea5cb3d9e727 55045-3198 HUMAN PRESCRIPTION DRUG Tamiflu oseltamivir phosphate POWDER, FOR SUSPENSION ORAL 20001214 NDA NDA021246 Dispensing Solutions, Inc. OSELTAMIVIR PHOSPHATE 12 mg/mL Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] E 20171231 55045-3207_f72addbb-85a1-4830-b6db-c2e964b03385 55045-3207 HUMAN PRESCRIPTION DRUG EpiPen Epinephrine INJECTION INTRAMUSCULAR 19871222 NDA NDA019430 Dispensing Solutions, Inc. EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 55045-3243_257ca1c6-80d4-478d-8d5b-f6a002c55983 55045-3243 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 19590528 NDA NDA011757 Dispensing Solutions, Inc. METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 55045-3248_e191c79d-3f8d-43fb-b10c-73eb5c150b02 55045-3248 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20090601 NDA NDA014901 Dispensing Solutions, Inc. TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 55045-3259_bce76198-3fdc-482e-8c03-31fd4e134aeb 55045-3259 HUMAN PRESCRIPTION DRUG TERCONAZOLE terconazole CREAM VAGINAL 20040401 NDA NDA019964 Dispensing Solutions, Inc. TERCONAZOLE 8 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] E 20171231 55045-3453_683a963a-2436-4330-85cf-29c6b255cb25 55045-3453 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Dispensing Solutions, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 55045-3598_e49b84de-9d18-439a-8c09-fdb24ba0179a 55045-3598 HUMAN PRESCRIPTION DRUG EpiPen Jr Epinephrine INJECTION INTRAMUSCULAR 19871222 NDA NDA019430 Dispensing Solutions, Inc. EPINEPHRINE .15 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 55045-3602_0b67b87e-09b2-4469-846e-52ea3f962018 55045-3602 HUMAN PRESCRIPTION DRUG Humalog Insulin lispro INJECTION, SOLUTION SUBCUTANEOUS 19960724 NDA NDA020563 Dispensing Solutions, Inc. INSULIN LISPRO 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 55045-3683_c1d3f51d-5d58-4d4e-9f7c-81e0734822b2 55045-3683 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19721127 ANDA ANDA080817 Dispensing Solutions, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 55045-3685_71907ed5-ee95-471a-8d7d-f72dcbbdfb60 55045-3685 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20090923 NDA NDA021081 Dispensing Solutions, Inc. INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 55045-3691_733ba226-4bba-4b0d-9bba-ec404e3c5977 55045-3691 HUMAN PRESCRIPTION DRUG Tretinoin tretinoin CREAM TOPICAL 19981224 ANDA ANDA075213 Dispensing Solutions, Inc. TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 55045-3693_beed0095-b4a2-4a71-b484-f27325bc899a 55045-3693 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 Dispensing Solutions, Inc. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 55045-3729_e75fe627-6f74-4e14-8b7e-0b360ebaee22 55045-3729 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Dispensing Solutions, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 55045-3817_e75fe627-6f74-4e14-8b7e-0b360ebaee22 55045-3817 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Dispensing Solutions, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 55045-3841_25851d21-e9bb-458f-a820-25f5d01ee97d 55045-3841 VACCINE HAVRIX Hepatitis A Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20070413 BLA BLA103475 Dispensing Solutions, Inc. HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 1440 [iU]/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] E 20171231 55045-3848_96dae489-ae80-4953-8d9a-df682794cbdf 55045-3848 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Dispensing Solutions, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 55050-0001_7e84fa10-b99a-4bc0-86d7-a69c8fa96b0e 55050-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19580101 UNAPPROVED MEDICAL GAS Holston Gases, Inc OXYGEN 99 L/100L E 20171231 55050-0006_57d22531-726e-431a-b05c-2f9d61a7adc2 55050-0006 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19580101 UNAPPROVED MEDICAL GAS Holston Gases, Inc NITROGEN 99 L/100L E 20171231 55050-0008_8f26ed93-327d-468a-ac00-c11e6aab2027 55050-0008 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19580101 UNAPPROVED MEDICAL GAS Holston Gases, Inc NITROUS OXIDE 99 kg/100kg E 20171231 55050-0011_a7dc6a5d-591b-4168-8703-cedb04d9447d 55050-0011 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19580101 NDA NDA205849 Holston Gases, Inc. OXYGEN 99 L/100L N 20181231 55050-0016_8cd47c4b-aa08-43ce-9342-0526b15489f5 55050-0016 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19580101 NDA NDA205850 Holston Gases, Inc NITROGEN 99 L/100L N 20181231 55050-0018_a954885c-1cb1-40b7-aae5-ce9bd9640bcf 55050-0018 HUMAN PRESCRIPTION DRUG NITROUS OXIDE NITROUS OXIDE GAS RESPIRATORY (INHALATION) 19580101 NDA NDA206009 Holston Gases, Inc NITROUS OXIDE 99 kg/100kg N 20181231 55056-0406_6ea8a930-2eae-435e-b13c-f2c9e9a4bf00 55056-0406 HUMAN PRESCRIPTION DRUG Prochieve progesterone GEL VAGINAL 19970513 NDA NDA020701 Columbia Laboratories PROGESTERONE 45 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 55056-0806_f2c9bbef-22b9-413b-930d-e84fbea8247b 55056-0806 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 NDA NDA020701 Columbia Laboratories, Inc. PROGESTERONE 90 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 55056-0808_f2c9bbef-22b9-413b-930d-e84fbea8247b 55056-0808 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 NDA NDA020701 Columbia Laboratories, Inc. PROGESTERONE 45 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 55056-0818_f2c9bbef-22b9-413b-930d-e84fbea8247b 55056-0818 HUMAN PRESCRIPTION DRUG Crinone progesterone GEL VAGINAL 19970513 NDA NDA020701 Columbia Laboratories, Inc. PROGESTERONE 90 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 55056-1601_6ea8a930-2eae-435e-b13c-f2c9e9a4bf00 55056-1601 HUMAN PRESCRIPTION DRUG Prochieve progesterone GEL VAGINAL 19970513 NDA NDA020701 Columbia Laboratories PROGESTERONE 90 mg/1.125g Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 55056-3060_b6cd73a8-8abb-4be4-9174-7215c1096287 55056-3060 HUMAN PRESCRIPTION DRUG Striant testosterone TABLET BUCCAL 20030619 NDA NDA021543 Columbia Laboratories, Inc. TESTOSTERONE 30 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII E 20171231 55071-001_0299d45c-b5e7-4391-bf59-b98ec0ace84d 55071-001 HUMAN OTC DRUG SUN SAVVY SOLAR SHIELD SPF 20 ZINC OXIDE TITANIUM DIOXIDE LOTION TOPICAL 20110326 OTC MONOGRAPH NOT FINAL part352 APPLIED SKIN TECHNOLOGY LLC ZINC OXIDE; TITANIUM DIOXIDE 5; 5 g/100mL; g/100mL E 20171231 55111-112_c1624465-1f12-8bef-12e6-7ccb688a1ae7 55111-112 HUMAN PRESCRIPTION DRUG Moxifloxacin Moxifloxacin TABLET, FILM COATED ORAL 20140305 ANDA ANDA076938 Dr. Reddy's Laboratories Limited MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55111-113_643c8768-63b9-8d6a-47dc-bb5a796e4d65 55111-113 HUMAN PRESCRIPTION DRUG ZENATANE ISOTRETINOIN CAPSULE, GELATIN COATED ORAL 20150309 ANDA ANDA202099 Dr. Reddy's Laboratories Limited ISOTRETINOIN 30 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 55111-118_96630fbf-75a9-3a2e-1069-e8c0b5505136 55111-118 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20060930 ANDA ANDA077367 Dr.Reddys Laboratories Limited FAMOTIDINE 10 mg/1 N 20181231 55111-119_47fe9600-534c-3502-b5fe-872b675c050e 55111-119 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075718 Dr.Reddy's Laboratories Limited FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55111-120_47fe9600-534c-3502-b5fe-872b675c050e 55111-120 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075718 Dr.Reddy's Laboratories Limited FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55111-121_047389c3-928e-54e8-cddb-b014acd31b79 55111-121 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 Dr. Reddy's Laboratories Limited ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-122_047389c3-928e-54e8-cddb-b014acd31b79 55111-122 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 Dr. Reddy's Laboratories Limited ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-123_047389c3-928e-54e8-cddb-b014acd31b79 55111-123 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 Dr. Reddy's Laboratories Limited ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-124_c7a835bf-340c-9364-cda8-b1365c3d4698 55111-124 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA202357 Dr. Reddy's Laboratories Limited ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-125_e9761e91-6a39-5e51-7bfd-236535d216e9 55111-125 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Dr. Reddy's Laboratories Limited CIPROFLOXACIN HYDROCHLORIDE 100 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55111-126_e9761e91-6a39-5e51-7bfd-236535d216e9 55111-126 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Dr. Reddy's Laboratories Limited CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55111-127_e9761e91-6a39-5e51-7bfd-236535d216e9 55111-127 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Dr. Reddy's Laboratories Limited CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55111-128_e9761e91-6a39-5e51-7bfd-236535d216e9 55111-128 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Dr. Reddy's Laboratories Limited CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55111-129_251eb18f-135d-8ea4-d16f-34e15f3451d3 55111-129 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 20010112 ANDA ANDA075742 Dr. Reddy's Laboratories Limited RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55111-130_251eb18f-135d-8ea4-d16f-34e15f3451d3 55111-130 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride CAPSULE ORAL 20010401 ANDA ANDA075742 Dr. Reddy's Laboratories Limited RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55111-131_109515ea-3048-acd0-bfbd-e083489525a2 55111-131 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20000301 ANDA ANDA075294 Dr. Reddy's Laboratories Limited RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 55111-133_8b3e7cd9-3a3d-7b47-d751-09ab6cee3d1b 55111-133 HUMAN PRESCRIPTION DRUG Enalapril maleate and hydrochlorothiazide Enalapril maleate and hydrochlorothiazide TABLET ORAL 20011015 ANDA ANDA075909 Dr. Reddy's Laboratories Limited ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55111-134_8b3e7cd9-3a3d-7b47-d751-09ab6cee3d1b 55111-134 HUMAN PRESCRIPTION DRUG Enalapril maleate and hydrochlorothiazide Enalapril maleate and hydrochlorothiazide TABLET ORAL 20011015 ANDA ANDA075909 Dr. Reddy's Laboratories Limited ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55111-135_643c8768-63b9-8d6a-47dc-bb5a796e4d65 55111-135 HUMAN PRESCRIPTION DRUG ZENATANE ISOTRETINOIN CAPSULE, GELATIN COATED ORAL 20130326 ANDA ANDA202099 Dr. Reddy's Laboratories Limited ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 55111-136_643c8768-63b9-8d6a-47dc-bb5a796e4d65 55111-136 HUMAN PRESCRIPTION DRUG ZENATANE ISOTRETINOIN CAPSULE, GELATIN COATED ORAL 20130326 ANDA ANDA202099 Dr. Reddy's Laboratories Limited ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 55111-137_643c8768-63b9-8d6a-47dc-bb5a796e4d65 55111-137 HUMAN PRESCRIPTION DRUG ZENATANE ISOTRETINOIN CAPSULE, GELATIN COATED ORAL 20130326 ANDA ANDA202099 Dr. Reddy's Laboratories Limited ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 55111-143_18630684-7e19-22a9-3b69-a6bc6bf4180c 55111-143 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140620 ANDA ANDA076658 Dr. Reddy's Laboratories Limited FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 55111-144_18630684-7e19-22a9-3b69-a6bc6bf4180c 55111-144 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140620 ANDA ANDA076658 Dr. Reddy's Laboratories Limited FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 55111-145_18630684-7e19-22a9-3b69-a6bc6bf4180c 55111-145 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140620 ANDA ANDA076658 Dr. Reddy's Laboratories Limited FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 55111-146_18630684-7e19-22a9-3b69-a6bc6bf4180c 55111-146 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140620 ANDA ANDA076658 Dr. Reddy's Laboratories Limited FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 55111-147_ecbf7c9a-2190-d50e-d23b-8f9c6a010ebc 55111-147 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20021015 ANDA ANDA075465 Dr.Reddy's Laboratories Limited FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-148_ecbf7c9a-2190-d50e-d23b-8f9c6a010ebc 55111-148 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20021015 ANDA ANDA075465 Dr.Reddy's Laboratories Limited FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-149_ecbf7c9a-2190-d50e-d23b-8f9c6a010ebc 55111-149 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20021015 ANDA ANDA075465 Dr.Reddy's Laboratories Limited FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-150_a2a1d290-d0ce-ed21-6261-db272714d092 55111-150 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine TABLET, FILM COATED ORAL 20160930 ANDA ANDA076006 Dr.Reddy's Laboratories Limited FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-153_e257810e-ee91-2847-a415-6114417c155d 55111-153 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20061226 ANDA ANDA076183 Dr.Reddy's Laboratories Limited ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55111-154_e257810e-ee91-2847-a415-6114417c155d 55111-154 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20061226 ANDA ANDA076183 Dr.Reddy's Laboratories Limited ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55111-156_e257810e-ee91-2847-a415-6114417c155d 55111-156 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20061226 ANDA ANDA076183 Dr.Reddy's Laboratories Limited ONDANSETRON HYDROCHLORIDE 24 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55111-157_3b18117e-f773-d25b-d646-a09ef337faa2 55111-157 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Dr. Reddy's Laboratories Limited OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55111-158_3b18117e-f773-d25b-d646-a09ef337faa2 55111-158 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Dr. Reddy's Laboratories Limited OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55111-159_3b18117e-f773-d25b-d646-a09ef337faa2 55111-159 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Dr. Reddy's Laboratories Limited OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55111-160_abfa4cd4-5c6d-62cd-3d3a-ff5a393b8301 55111-160 HUMAN PRESCRIPTION DRUG Ofloxacin ofloxacin TABLET, COATED ORAL 20060210 ANDA ANDA077098 Dr. Reddy's Laboratories Limited OFLOXACIN 200 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55111-161_abfa4cd4-5c6d-62cd-3d3a-ff5a393b8301 55111-161 HUMAN PRESCRIPTION DRUG Ofloxacin ofloxacin TABLET, COATED ORAL 20060210 ANDA ANDA077098 Dr. Reddy's Laboratories Limited OFLOXACIN 300 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55111-162_abfa4cd4-5c6d-62cd-3d3a-ff5a393b8301 55111-162 HUMAN PRESCRIPTION DRUG Ofloxacin ofloxacin TABLET, COATED ORAL 20060210 ANDA ANDA077098 Dr. Reddy's Laboratories Limited OFLOXACIN 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55111-163_d3e8569c-09c8-c5d7-2a2f-36474150df92 55111-163 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Dr. Reddy's Laboratories Ltd. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-167_16d73e52-32b7-5a1c-c282-f414f543fb45 55111-167 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076133 Dr. Reddy's Laboratories Ltd. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-168_16d73e52-32b7-5a1c-c282-f414f543fb45 55111-168 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076133 Dr. Reddy's Laboratories Ltd. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-169_6cdd58c2-e88f-75dc-aae3-17dfe8ed1dfb 55111-169 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-170_faf7f9bf-1a34-f250-4085-5ca4d340b014 55111-170 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20010131 ANDA ANDA075855 Dr. Reddy's Laboratories Limited OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55111-171_0917aaac-8122-3208-97f8-33205bc7dbb2 55111-171 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130102 ANDA ANDA076436 Dr. Reddy's Laboratories Limited FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 55111-172_1ea3d91d-9eae-f0cb-c631-141801302811 55111-172 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20070228 ANDA ANDA076437 Dr. Reddy's Laboratories Limited FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 55111-179_06410d16-2b8f-c42a-b938-6d1491b31b6f 55111-179 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Dr. Reddy's Laboratories Limited TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55111-180_06410d16-2b8f-c42a-b938-6d1491b31b6f 55111-180 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Dr. Reddy's Laboratories Limited TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55111-181_1953d6dd-5f8e-8dba-7067-5854b0ac7ebc 55111-181 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA076920 Dr. Reddy's Laboratories Limited LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55111-182_1953d6dd-5f8e-8dba-7067-5854b0ac7ebc 55111-182 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA076920 Dr. Reddy's Laboratories Limited LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55111-183_1953d6dd-5f8e-8dba-7067-5854b0ac7ebc 55111-183 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA076920 Dr. Reddy's Laboratories Limited LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55111-186_6cdd58c2-e88f-75dc-aae3-17dfe8ed1dfb 55111-186 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-188_6cdd58c2-e88f-75dc-aae3-17dfe8ed1dfb 55111-188 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-189_6cdd58c2-e88f-75dc-aae3-17dfe8ed1dfb 55111-189 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-190_6cdd58c2-e88f-75dc-aae3-17dfe8ed1dfb 55111-190 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-196_0773fe5a-25e6-3cbc-30a7-e5a4b511ee24 55111-196 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076273 Dr.Reddy's Laboratories Limited CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 55111-197_afb8cf92-de9d-af77-383d-6f37de3de331 55111-197 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20070816 ANDA ANDA078425 Dr. Reddy's Laboratories Limited SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-198_afb8cf92-de9d-af77-383d-6f37de3de331 55111-198 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Dr. Reddy's Laboratories Limited SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-199_afb8cf92-de9d-af77-383d-6f37de3de331 55111-199 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Dr. Reddy's Laboratories Limited SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-200_afb8cf92-de9d-af77-383d-6f37de3de331 55111-200 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Dr. Reddy's Laboratories Limited SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-201_bf566e93-0213-79fe-a099-32afa6cb9628 55111-201 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091024 ANDA ANDA076879 Dr. Reddy's Laboratories Limited RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-202_bf566e93-0213-79fe-a099-32afa6cb9628 55111-202 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091024 ANDA ANDA076879 Dr. Reddy's Laboratories Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-203_bf566e93-0213-79fe-a099-32afa6cb9628 55111-203 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091024 ANDA ANDA076879 Dr. Reddy's Laboratories Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-204_bf566e93-0213-79fe-a099-32afa6cb9628 55111-204 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091024 ANDA ANDA076879 Dr. Reddy's Laboratories Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-205_bf566e93-0213-79fe-a099-32afa6cb9628 55111-205 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091024 ANDA ANDA076879 Dr. Reddy's Laboratories Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-206_bf566e93-0213-79fe-a099-32afa6cb9628 55111-206 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20091024 ANDA ANDA076879 Dr. Reddy's Laboratories Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-207_ac177954-89c1-bc76-e5c1-c358547729e8 55111-207 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090224 ANDA ANDA077328 Dr. Reddy's Laboratories Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-208_ac177954-89c1-bc76-e5c1-c358547729e8 55111-208 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091006 ANDA ANDA077328 Dr. Reddy's Laboratories Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-209_ac177954-89c1-bc76-e5c1-c358547729e8 55111-209 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20090224 ANDA ANDA077328 Dr. Reddy's Laboratories Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-220_4c472709-29e3-2216-0e25-f4d4b3ec3200 55111-220 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090129 ANDA ANDA076708 Dr.Reddy's Laboratories Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-221_4c472709-29e3-2216-0e25-f4d4b3ec3200 55111-221 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090129 ANDA ANDA076708 Dr.Reddy's Laboratories Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-222_4c472709-29e3-2216-0e25-f4d4b3ec3200 55111-222 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090129 ANDA ANDA076708 Dr.Reddy's Laboratories Limited LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-223_4c472709-29e3-2216-0e25-f4d4b3ec3200 55111-223 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090129 ANDA ANDA076708 Dr.Reddy's Laboratories Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-225_f71e4461-dcd4-98fc-52b3-3e5c014d63d0 55111-225 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090129 ANDA ANDA076701 Dr. Reddy's Laboratories Limited LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-226_f71e4461-dcd4-98fc-52b3-3e5c014d63d0 55111-226 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090129 ANDA ANDA076701 Dr. Reddy's Laboratories Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-229_d16f3c67-24f3-8640-1482-f54b072c9ed7 55111-229 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20091231 ANDA ANDA076714 Dr.Reddy's Laboratories Limited PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-230_d16f3c67-24f3-8640-1482-f54b072c9ed7 55111-230 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20091231 ANDA ANDA076714 Dr.Reddy's Laboratories Limited PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-231_d16f3c67-24f3-8640-1482-f54b072c9ed7 55111-231 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20091231 ANDA ANDA076714 Dr.Reddy's Laboratories Limited PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-248_960b7dc9-dd89-c124-1e63-c4456ea8a0cf 55111-248 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078904 Dr. Reddy's Laboratories Limited LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55111-249_6cdd58c2-e88f-75dc-aae3-17dfe8ed1dfb 55111-249 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-250_13451699-7b0c-6dd9-7c7c-ff9b55a613d4 55111-250 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20070702 ANDA ANDA076390 Dr.Reddys Laboratories Limited TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 55111-252_87dce662-c425-8eaa-7e2d-9c458421513d 55111-252 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Dr. Reddy's Laboratories Limited CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 55111-253_87dce662-c425-8eaa-7e2d-9c458421513d 55111-253 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Dr. Reddy's Laboratories Limited CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 55111-254_87dce662-c425-8eaa-7e2d-9c458421513d 55111-254 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Dr. Reddy's Laboratories Limited CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 55111-255_87dce662-c425-8eaa-7e2d-9c458421513d 55111-255 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Dr. Reddy's Laboratories Limited CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 55111-256_ebaa55e9-6c67-62df-81a8-453ad4f76516 55111-256 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 Dr. Reddy's Laboratories Limited ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-257_ebaa55e9-6c67-62df-81a8-453ad4f76516 55111-257 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 Dr. Reddy's Laboratories Limited ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-258_ebaa55e9-6c67-62df-81a8-453ad4f76516 55111-258 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 Dr. Reddy's Laboratories Limited ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-259_ebaa55e9-6c67-62df-81a8-453ad4f76516 55111-259 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 Dr. Reddy's Laboratories Limited ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-262_3b3070ff-cdb0-5ed2-1d41-ec973621262a 55111-262 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA076534 Dr.Reddy's Laboratories Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-263_3b3070ff-cdb0-5ed2-1d41-ec973621262a 55111-263 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA076534 Dr.Reddy's Laboratories Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-264_3b3070ff-cdb0-5ed2-1d41-ec973621262a 55111-264 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA076534 Dr.Reddy's Laboratories Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-265_3b3070ff-cdb0-5ed2-1d41-ec973621262a 55111-265 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA076534 Dr.Reddy's Laboratories Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-268_afb8cf92-de9d-af77-383d-6f37de3de331 55111-268 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Dr. Reddy's Laboratories Limited SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-269_b1a220cd-5b4e-2660-4728-73b07ce5ed4e 55111-269 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070723 ANDA ANDA076692 Dr Reddy's Laboratories AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55111-270_b1a220cd-5b4e-2660-4728-73b07ce5ed4e 55111-270 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070723 ANDA ANDA076692 Dr Reddy's Laboratories AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55111-271_b1a220cd-5b4e-2660-4728-73b07ce5ed4e 55111-271 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070723 ANDA ANDA076692 Dr Reddy's Laboratories AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55111-272_b8cbfcde-dc47-157b-bf85-c1750343ee09 55111-272 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, COATED ORAL 19980729 ANDA ANDA075168 Dr.Reddy's Laboratories Limited NAPROXEN SODIUM 220 mg/1 N 20181231 55111-273_b8cbfcde-dc47-157b-bf85-c1750343ee09 55111-273 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, COATED ORAL 19980729 ANDA ANDA075168 Dr.Reddy's Laboratories Limited NAPROXEN SODIUM 220 mg/1 N 20181231 55111-274_d16f3c67-24f3-8640-1482-f54b072c9ed7 55111-274 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20091231 ANDA ANDA076714 Dr.Reddy's Laboratories Limited PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55111-279_f9efa2ee-bc43-636e-cd21-b0a77e8d110a 55111-279 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076710 Dr. Reddy's Laboratories Limited LEVOFLOXACIN 250 mg/1 N 20181231 55111-280_f9efa2ee-bc43-636e-cd21-b0a77e8d110a 55111-280 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076710 Dr. Reddy's Laboratories Limited LEVOFLOXACIN 500 mg/1 N 20181231 55111-281_f9efa2ee-bc43-636e-cd21-b0a77e8d110a 55111-281 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076710 Dr. Reddy's Laboratories Limited LEVOFLOXACIN 750 mg/1 N 20181231 55111-282_4a494886-07b0-ece6-cde4-52b3e25e32a0 55111-282 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride levocetirizine dihydrochloride TABLET, COATED ORAL 20110224 ANDA ANDA090392 Dr.Reddy's laboratories Ltd. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 55111-284_6456b555-7b48-8015-3b72-debccff88adc 55111-284 HUMAN PRESCRIPTION DRUG Fluoxetine hydrochloride Fluoxetine Hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 20100324 ANDA ANDA078572 Dr.Reddy's Laboratories Limited FLUOXETINE HYDROCHLORIDE 90 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-288_e744c323-e44f-3dce-02c3-4faa458ec24f 55111-288 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077645 Dr. Reddy's Laboratories Limited ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55111-291_28538531-e60a-9b6e-0075-6fad1192eed3 55111-291 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Dr. Reddy's Laboratories Limited SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 55111-292_28538531-e60a-9b6e-0075-6fad1192eed3 55111-292 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Dr. Reddy's Laboratories Limited SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 55111-293_28538531-e60a-9b6e-0075-6fad1192eed3 55111-293 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Dr. Reddy's Laboratories Limited SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 55111-302_fa7564aa-eb83-b693-d947-08b227dfbd55 55111-302 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20130726 ANDA ANDA202723 Dr. Reddys Laboratories Limited DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 55111-310_a22628e4-69b2-d4af-ece1-39f62ed1f89f 55111-310 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20050915 ANDA ANDA077314 Dr Reddy's Laboratories Limited NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55111-311_a22628e4-69b2-d4af-ece1-39f62ed1f89f 55111-311 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20050915 ANDA ANDA077314 Dr Reddy's Laboratories Limited NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55111-320_57070deb-dfc5-701b-1979-36d4f6ba5c9a 55111-320 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Dr. Reddy's Laboratories Limited GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 55111-321_57070deb-dfc5-701b-1979-36d4f6ba5c9a 55111-321 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Dr. Reddy's Laboratories Limited GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 55111-322_57070deb-dfc5-701b-1979-36d4f6ba5c9a 55111-322 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Dr. Reddy's Laboratories Limited GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 55111-328_7a130a11-a0a6-b96d-6862-850a291401fd 55111-328 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET ORAL 20090909 ANDA ANDA077461 Dr. Reddy's Laboratories Limited NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 55111-329_7a130a11-a0a6-b96d-6862-850a291401fd 55111-329 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET ORAL 20090909 ANDA ANDA077461 Dr. Reddy's Laboratories Limited NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 55111-332_1b82e5ba-f557-b840-6129-3a0c8cfc6c1d 55111-332 HUMAN PRESCRIPTION DRUG Pantoprazole Pantoprazole TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA077619 Dr.Reddy's Laboratories Limited PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 55111-333_1b82e5ba-f557-b840-6129-3a0c8cfc6c1d 55111-333 HUMAN PRESCRIPTION DRUG Pantoprazole Pantoprazole TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA077619 Dr.Reddy's Laboratories Limited PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 55111-338_05c1b528-8067-4327-9f50-67d1a73ceb01 55111-338 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Dr.Reddy's Laboratories Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55111-339_05c1b528-8067-4327-9f50-67d1a73ceb01 55111-339 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Dr.Reddy's Laboratories Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55111-340_05c1b528-8067-4327-9f50-67d1a73ceb01 55111-340 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Dr.Reddy's Laboratories Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55111-341_05c1b528-8067-4327-9f50-67d1a73ceb01 55111-341 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 Dr.Reddy's Laboratories Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55111-342_2153f0e6-6744-ce86-8829-f6e7adf4b35d 55111-342 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077038 Dr. Reddy's Laboratories Limited CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-343_2153f0e6-6744-ce86-8829-f6e7adf4b35d 55111-343 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077038 Dr. Reddy's Laboratories Limited CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-344_2153f0e6-6744-ce86-8829-f6e7adf4b35d 55111-344 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077038 Dr. Reddy's Laboratories Limited CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-349_df5e742b-3afc-0e96-1566-1770adfd36a7 55111-349 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20140407 ANDA ANDA090859 Dr. Reddy's Laboratories Limited FENOFIBRATE 43 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 55111-351_7136a472-c852-a4a1-9e11-c8dcb8b14a1f 55111-351 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20080115 ANDA ANDA078343 Dr.Reddy's Laboratories Limited CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55111-352_7273ebee-c304-4b6e-f8b2-b7029b6830a8 55111-352 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20110901 ANDA ANDA077130 Dr. Reddy's Laboratories Limited RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 55111-353_7273ebee-c304-4b6e-f8b2-b7029b6830a8 55111-353 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20110901 ANDA ANDA077130 Dr. Reddy's Laboratories Limited RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 55111-354_7273ebee-c304-4b6e-f8b2-b7029b6830a8 55111-354 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20110901 ANDA ANDA077130 Dr. Reddy's Laboratories Limited RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 55111-355_7273ebee-c304-4b6e-f8b2-b7029b6830a8 55111-355 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20110901 ANDA ANDA077130 Dr. Reddy's Laboratories Limited RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 55111-356_9d683da1-2be2-b2b4-892a-2d47b3de2a0c 55111-356 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 Dr. Reddys Laboratories Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 55111-357_9d683da1-2be2-b2b4-892a-2d47b3de2a0c 55111-357 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA201001 Dr. Reddys Laboratories Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 55111-360_38968cad-4da0-33be-9c26-918d28092f98 55111-360 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET, ORALLY DISINTEGRATING ORAL 20130111 ANDA ANDA078367 Dr. Reddy's Laboratories Limited DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 55111-363_289498c6-fc25-2bb2-6b84-ee25b331ed18 55111-363 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicrabonate Omeprazole and Sodium Bicrabonate CAPSULE ORAL 20160715 ANDA ANDA204068 Dr.Reddy's Laboratories Limited OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55111-364_289498c6-fc25-2bb2-6b84-ee25b331ed18 55111-364 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicrabonate Omeprazole and Sodium Bicrabonate CAPSULE ORAL 20160715 ANDA ANDA204068 Dr.Reddy's Laboratories Limited OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55111-395_df5e742b-3afc-0e96-1566-1770adfd36a7 55111-395 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20140407 ANDA ANDA090859 Dr. Reddy's Laboratories Limited FENOFIBRATE 130 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 55111-396_96630fbf-75a9-3a2e-1069-e8c0b5505136 55111-396 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20060930 ANDA ANDA077367 Dr.Reddys Laboratories Limited FAMOTIDINE 20 mg/1 N 20181231 55111-397_1108f6af-d279-76f8-6c37-593c9e45d429 55111-397 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20100301 ANDA ANDA078878 Dr. Reddy's Laboratories Limited OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 55111-397_b22f1035-a8e5-17be-0850-058295a39a04 55111-397 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20091112 ANDA ANDA078878 Dr. Reddy's Laboratories Limited OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 55111-398_b6e8183c-fb17-dc8e-2f55-a9d8af3df1e7 55111-398 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 Dr.Reddy's Laboratories Ltd. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 55111-399_b6e8183c-fb17-dc8e-2f55-a9d8af3df1e7 55111-399 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 Dr.Reddy's Laboratories Ltd. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 55111-402_e744c323-e44f-3dce-02c3-4faa458ec24f 55111-402 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077645 Dr. Reddy's Laboratories Limited ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55111-403_e744c323-e44f-3dce-02c3-4faa458ec24f 55111-403 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077645 Dr. Reddy's Laboratories Limited ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55111-404_8da353f4-4588-3f83-f4b8-c07f4c91dd3d 55111-404 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, COATED ORAL 20091202 ANDA ANDA078192 Dr. Reddy's Laboratories Limited RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 55111-422_52f816f4-05ac-1372-790b-a02129c1d94e 55111-422 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070326 ANDA ANDA077902 Dr. Reddy's Laboratories Limited CIPROFLOXACIN HYDROCHLORIDE; CIPROFLOXACIN 287.5; 212.6 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55111-423_52f816f4-05ac-1372-790b-a02129c1d94e 55111-423 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071031 ANDA ANDA077701 Dr. Reddy's Laboratories Limited CIPROFLOXACIN HYDROCHLORIDE; CIPROFLOXACIN 574.9; 425.2 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55111-428_873e3cd8-700a-4bea-f943-d84bb6e5ff69 55111-428 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20130620 ANDA ANDA202383 Dr.Reddy's Laboratories Limited LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-438_5fe1152c-5845-8a8d-9604-dd72d74f71b6 55111-438 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA078191 Dr. Reddy's Laboratories Limited RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55111-439_5fe1152c-5845-8a8d-9604-dd72d74f71b6 55111-439 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA078191 Dr. Reddy's Laboratories Limited RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55111-440_5fe1152c-5845-8a8d-9604-dd72d74f71b6 55111-440 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA078191 Dr. Reddy's Laboratories Limited RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55111-441_5fe1152c-5845-8a8d-9604-dd72d74f71b6 55111-441 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA078191 Dr. Reddy's Laboratories Limited RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55111-447_e0a7f340-e70c-17b7-0586-9a4dffe078bd 55111-447 HUMAN OTC DRUG Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE ORAL 20141118 ANDA ANDA076667 Dr. Reddy's Laboratories Limited FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 N 20181231 55111-453_4bd8053c-85ea-46fa-2f78-c47c3baf96b7 55111-453 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078421 Dr.Reddy's Laboratories Ltd. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-454_4bd8053c-85ea-46fa-2f78-c47c3baf96b7 55111-454 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078421 Dr.Reddy's Laboratories Ltd. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-455_4bd8053c-85ea-46fa-2f78-c47c3baf96b7 55111-455 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078421 Dr.Reddy's Laboratories Ltd. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-466_a3f2a4a8-d4c9-8d2c-e6fb-2c0e1be01920 55111-466 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Dr. Reddy's Laboratories Limited METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55111-467_a3f2a4a8-d4c9-8d2c-e6fb-2c0e1be01920 55111-467 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Dr. Reddy's Laboratories Limited METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55111-468_54739fcb-9638-16b7-0659-23b5def2703e 55111-468 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 Dr. Reddy's Laboratories Limited METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55111-469_54739fcb-9638-16b7-0659-23b5def2703e 55111-469 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 Dr. Reddy's Laboratories Limited METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55111-470_ac177954-89c1-bc76-e5c1-c358547729e8 55111-470 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091130 ANDA ANDA077328 Dr. Reddy's Laboratories Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-471_ac177954-89c1-bc76-e5c1-c358547729e8 55111-471 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20091130 ANDA ANDA077328 Dr. Reddy's Laboratories Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-472_e4f9b1c3-d3ff-9ba2-9232-758efe2752d4 55111-472 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20090304 ANDA ANDA078246 Dr. Reddy's Laboratories Limited BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 55111-473_e4f9b1c3-d3ff-9ba2-9232-758efe2752d4 55111-473 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20090304 ANDA ANDA078246 Dr. Reddy's Laboratories Limited BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 55111-474_e4f9b1c3-d3ff-9ba2-9232-758efe2752d4 55111-474 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20090304 ANDA ANDA078246 Dr. Reddy's Laboratories Limited BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 55111-475_e4f9b1c3-d3ff-9ba2-9232-758efe2752d4 55111-475 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20090304 ANDA ANDA078246 Dr. Reddy's Laboratories Limited BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 55111-476_6f5c36d3-3f99-803c-5be6-66b2e1058946 55111-476 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20081003 ANDA ANDA040862 Dr. Reddy's Laboratories Limited PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55111-477_6f5c36d3-3f99-803c-5be6-66b2e1058946 55111-477 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20081003 ANDA ANDA040862 Dr. Reddy's Laboratories Limited PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55111-478_d5aeb471-b5af-b169-c662-938ae8c15d8e 55111-478 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA077985 Dr. Reddy's Laboratories Limited ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 55111-479_d5aeb471-b5af-b169-c662-938ae8c15d8e 55111-479 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA077985 Dr. Reddy's Laboratories Limited ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 55111-486_6f45c84c-c02a-9285-e078-a5f7a3acafc8 55111-486 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20150810 ANDA ANDA078420 Dr. Reddy's Laboratories Limited NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55111-487_6f45c84c-c02a-9285-e078-a5f7a3acafc8 55111-487 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20150810 ANDA ANDA078420 Dr. Reddy's Laboratories Limited NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55111-492_be04a674-2f3c-368a-c3cf-0fb65f736cbc 55111-492 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20150925 ANDA ANDA078279 Dr. Reddy's Laboratories Limited ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55111-493_be04a674-2f3c-368a-c3cf-0fb65f736cbc 55111-493 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20150925 ANDA ANDA078279 Dr. Reddy's Laboratories Limited ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55111-525_7239c55d-bcca-938d-0995-2b627f843a20 55111-525 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100514 ANDA ANDA090509 Dr. Reddy's Laboratories Limited TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 55111-526_7239c55d-bcca-938d-0995-2b627f843a20 55111-526 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100514 ANDA ANDA090509 Dr. Reddy's Laboratories Limited TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 55111-527_7239c55d-bcca-938d-0995-2b627f843a20 55111-527 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100514 ANDA ANDA090509 Dr. Reddy's Laboratories Limited TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 55111-529_c63f181a-0b57-aaa0-e04c-ad7e6ca7649c 55111-529 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078755 Dr. Reddy's Laboratories Ltd DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-530_c63f181a-0b57-aaa0-e04c-ad7e6ca7649c 55111-530 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078755 Dr. Reddy's Laboratories Ltd DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-531_c63f181a-0b57-aaa0-e04c-ad7e6ca7649c 55111-531 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078755 Dr. Reddy's Laboratories Ltd DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-532_c8dbbaf6-269d-1197-74b5-c67a98563f84 55111-532 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium CAPSULE ORAL 20090123 ANDA ANDA078979 Dr. Reddy's Laboratories Ltd DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-533_d44b0589-3ec9-6066-258d-9db9b33cbd94 55111-533 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130811 ANDA ANDA090161 Dr. Reddy's Laboratories Ltd DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-534_6b8aea0b-5a37-5309-bf6d-de94988fd5e9 55111-534 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130811 ANDA ANDA090070 Dr. Reddy's Laboratories Ltd DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-545_d23adbf8-2c6a-76ae-c7e7-4dfa626a560d 55111-545 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride TABLET ORAL 20080616 ANDA ANDA078301 Dr. Reddy's Laboratories Limited VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-546_d23adbf8-2c6a-76ae-c7e7-4dfa626a560d 55111-546 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride TABLET ORAL 20080616 ANDA ANDA078301 Dr. Reddy's Laboratories Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-547_d23adbf8-2c6a-76ae-c7e7-4dfa626a560d 55111-547 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride TABLET ORAL 20080616 ANDA ANDA078301 Dr. Reddy's Laboratories Limited VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-548_d23adbf8-2c6a-76ae-c7e7-4dfa626a560d 55111-548 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride TABLET ORAL 20080616 ANDA ANDA078301 Dr. Reddy's Laboratories Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-549_d23adbf8-2c6a-76ae-c7e7-4dfa626a560d 55111-549 HUMAN PRESCRIPTION DRUG Venlafaxine hydrochloride Venlafaxine hydrochloride TABLET ORAL 20080616 ANDA ANDA078301 Dr. Reddy's Laboratories Limited VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-551_38968cad-4da0-33be-9c26-918d28092f98 55111-551 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET, ORALLY DISINTEGRATING ORAL 20130111 ANDA ANDA078367 Dr. Reddy's Laboratories Limited DESLORATADINE 2.5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 55111-552_8d4b0d73-3618-171b-e90a-fdeeeded3810 55111-552 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20101206 ANDA ANDA079012 Dr. Reddys Laboratories Limited VALACYCLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55111-553_8d4b0d73-3618-171b-e90a-fdeeeded3810 55111-553 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20101206 ANDA ANDA079012 Dr. Reddys Laboratories Limited VALACYCLOVIR 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55111-556_c468198c-22cb-9c85-6613-88c3176e9602 55111-556 HUMAN PRESCRIPTION DRUG Decitabine Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130711 ANDA ANDA203131 Dr.Reddy's Laboratories Limited DECITABINE 50 mg/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 55111-557_5cfa5dd8-316d-c497-68dd-ab357e8eaff7 55111-557 HUMAN OTC DRUG Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE ORAL 20110824 ANDA ANDA079043 Dr.Reddy's Laboratories Limited FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 N 20181231 55111-565_2b892a41-1540-179c-df44-322f3c3ba529 55111-565 HUMAN OTC DRUG Ibuprofen and Diphenhydramine Citrate Ibuprofen and Diphenhydramine Citrate TABLET ORAL 20100131 ANDA ANDA090619 Dr. Reddy's Laboratories Limited IBUPROFEN; DIPHENHYDRAMINE CITRATE 200; 38 mg/1; mg/1 N 20181231 55111-572_83e76d7d-2a89-fe13-b319-56a5470a69b0 55111-572 HUMAN PRESCRIPTION DRUG Fexofenadine HCl and Pseudoephedrine HCl Fexofenadine HCl and Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20110128 ANDA ANDA079043 Dr.Reddy's Laboratories Limited FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180; 240 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 55111-575_0dd46456-30d4-b99f-c625-8bf0eecd8eb7 55111-575 HUMAN PRESCRIPTION DRUG Ibandronate sodium Ibandronate sodium TABLET ORAL 20120621 ANDA ANDA078997 Dr. Reddy's Laboratories Limited IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 55111-579_38aae1c5-bc93-a425-927b-d976faf90bb4 55111-579 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20090729 ANDA ANDA078909 Dr. Reddy's Laboratories Limited RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 55111-586_152876dd-13bc-aae3-eb66-4a5c7e396a47 55111-586 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090149 Dr.Reddy's Laboratories Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55111-587_152876dd-13bc-aae3-eb66-4a5c7e396a47 55111-587 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090149 Dr.Reddy's Laboratories Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55111-593_81dd061b-5e16-8258-92ab-e972ffade75b 55111-593 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120806 ANDA ANDA201581 Dr.Reddy's Laboratories Limited MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 55111-594_81dd061b-5e16-8258-92ab-e972ffade75b 55111-594 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120806 ANDA ANDA201581 Dr.Reddy's Laboratories Limited MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 55111-596_82c2f213-3f97-eb81-2761-7bcc1afb7878 55111-596 HUMAN PRESCRIPTION DRUG Memantine Memantine TABLET ORAL 20150711 ANDA ANDA090048 Dr. Reddys Laboratories Limited MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 55111-597_82c2f213-3f97-eb81-2761-7bcc1afb7878 55111-597 HUMAN PRESCRIPTION DRUG Memantine Memantine TABLET ORAL 20150711 ANDA ANDA090048 Dr. Reddys Laboratories Limited MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 55111-602_5d1e0596-f1ae-ff0a-babb-dd16a97d915e 55111-602 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SYRUP ORAL 20090526 ANDA ANDA090102 Dr. Reddy's Laboratories Limited RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55111-606_6cdd58c2-e88f-75dc-aae3-17dfe8ed1dfb 55111-606 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077380 Dr.Reddy's Laboratories Limited QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 55111-608_4c558e81-93a2-83cc-8239-3d0a895052d2 55111-608 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20140618 ANDA ANDA090723 Dr. Reddy's Laboratories Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-609_4c558e81-93a2-83cc-8239-3d0a895052d2 55111-609 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20140618 ANDA ANDA090723 Dr. Reddy's Laboratories Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-610_4c558e81-93a2-83cc-8239-3d0a895052d2 55111-610 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20140618 ANDA ANDA090723 Dr. Reddy's Laboratories Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55111-611_9c228f27-c350-ad6f-134d-46a060ee54b9 55111-611 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20150814 ANDA ANDA203354 Dr. Reddy's Laboratories Limited PRAMIPEXOLE DIHYDROCHLORIDE .375 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55111-612_9c228f27-c350-ad6f-134d-46a060ee54b9 55111-612 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20150814 ANDA ANDA203354 Dr. Reddy's Laboratories Limited PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55111-613_9c228f27-c350-ad6f-134d-46a060ee54b9 55111-613 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20150814 ANDA ANDA203354 Dr. Reddy's Laboratories Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55111-614_9c228f27-c350-ad6f-134d-46a060ee54b9 55111-614 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20150814 ANDA ANDA203354 Dr. Reddy's Laboratories Limited PRAMIPEXOLE DIHYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55111-615_9c228f27-c350-ad6f-134d-46a060ee54b9 55111-615 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET, EXTENDED RELEASE ORAL 20150814 ANDA ANDA203354 Dr. Reddy's Laboratories Limited PRAMIPEXOLE DIHYDROCHLORIDE 4.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55111-617_780e4441-5eb7-66ef-045a-6895c74a5915 55111-617 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, COATED ORAL 20140415 ANDA ANDA091024 Dr. Reddy's Laboratories Limited ESZOPICLONE 3 mg/1 CIV N 20181231 55111-619_780e4441-5eb7-66ef-045a-6895c74a5915 55111-619 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, COATED ORAL 20140415 ANDA ANDA091024 Dr. Reddy's Laboratories Limited ESZOPICLONE 2 mg/1 CIV N 20181231 55111-621_58a1cc9b-12bf-5c5c-576b-cde2b5bb64bf 55111-621 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070720 ANDA ANDA078457 Dr.Reddy's Laboratories Limited QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55111-622_58a1cc9b-12bf-5c5c-576b-cde2b5bb64bf 55111-622 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070720 ANDA ANDA078457 Dr.Reddy's Laboratories Limited QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55111-623_58a1cc9b-12bf-5c5c-576b-cde2b5bb64bf 55111-623 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070720 ANDA ANDA078457 Dr.Reddy's Laboratories Limited QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55111-624_58a1cc9b-12bf-5c5c-576b-cde2b5bb64bf 55111-624 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070720 ANDA ANDA078457 Dr.Reddy's Laboratories Limited QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55111-625_f8d7ff01-8167-c19d-4889-c944fb9dc74c 55111-625 HUMAN PRESCRIPTION DRUG Zafirlukast Zafirlukast TABLET, FILM COATED ORAL 20101118 ANDA ANDA090372 Dr. Reddys Laboratories Limited ZAFIRLUKAST 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 55111-626_f8d7ff01-8167-c19d-4889-c944fb9dc74c 55111-626 HUMAN PRESCRIPTION DRUG Zafirlukast Zafirlukast TABLET, FILM COATED ORAL 20101118 ANDA ANDA090372 Dr. Reddys Laboratories Limited ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 55111-629_780e4441-5eb7-66ef-045a-6895c74a5915 55111-629 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, COATED ORAL 20140415 ANDA ANDA091024 Dr. Reddy's Laboratories Limited ESZOPICLONE 1 mg/1 CIV N 20181231 55111-637_447b8e6a-75d3-b780-ae65-31de0ef8e805 55111-637 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20080123 ANDA ANDA065436 Dr. Reddy's Laboratories Limited MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 55111-638_447b8e6a-75d3-b780-ae65-31de0ef8e805 55111-638 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20080123 ANDA ANDA065436 Dr. Reddy's Laboratories Limited MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 55111-639_447b8e6a-75d3-b780-ae65-31de0ef8e805 55111-639 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20080123 ANDA ANDA065436 Dr. Reddy's Laboratories Limited MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 55111-640_4995ef74-5377-6fdf-5a0a-0ea1925c35fb 55111-640 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20080103 ANDA ANDA040797 Dr.Reddy's Laboratories Limited MEPROBAMATE 200 mg/1 CIV N 20181231 55111-641_4995ef74-5377-6fdf-5a0a-0ea1925c35fb 55111-641 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20080103 ANDA ANDA040797 Dr.Reddy's Laboratories Limited MEPROBAMATE 400 mg/1 CIV N 20181231 55111-643_b6547272-af0e-1240-c3c0-c0dbb3df0cdf 55111-643 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20140301 ANDA ANDA078490 Dr. Reddy's Laboratories Limited OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55111-644_b6547272-af0e-1240-c3c0-c0dbb3df0cdf 55111-644 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20140301 ANDA ANDA078490 Dr. Reddy's Laboratories Limited OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55111-645_b6547272-af0e-1240-c3c0-c0dbb3df0cdf 55111-645 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20140301 ANDA ANDA078490 Dr. Reddy's Laboratories Limited OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55111-646_e38a7bdd-e85a-2f03-c868-036ff4bbf812 55111-646 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20110603 ANDA ANDA091191 Dr. Reddy's Laboratories Limited LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 55111-647_2995fa61-2385-f7e1-d028-beca0e052a3d 55111-647 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20100628 ANDA ANDA090732 Dr. Reddy's Laboratories Limited ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 55111-648_e4e71ffb-deea-6f0a-2928-c81a29b2c15c 55111-648 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20080714 ANDA ANDA040847 Dr. Reddy's Laboratories Limited GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 55111-649_e4e71ffb-deea-6f0a-2928-c81a29b2c15c 55111-649 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20080714 ANDA ANDA040847 Dr. Reddy's Laboratories Limited GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 55111-650_f428cfcf-fea9-42e3-abab-05d5cb558622 55111-650 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20170831 ANDA ANDA207466 Dr. Reddy’s Laboratories Limited METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 55111-652_dcce401c-8b96-6ede-ae53-bf7b60d79f13 55111-652 HUMAN PRESCRIPTION DRUG Bivalirudin Bivalirudin INJECTION INTRACAVERNOUS 20170531 ANDA ANDA201577 Dr. Reddy's Laboratories Limited BIVALIRUDIN 250 mg/1 Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 55111-653_7fdf31c2-81f5-d5a5-75e7-74225e4f5441 55111-653 HUMAN PRESCRIPTION DRUG Sirolimus Sirolimus TABLET ORAL 20141027 ANDA ANDA201578 Dr. Reddy's Laboratories Limited SIROLIMUS 1 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 55111-654_7fdf31c2-81f5-d5a5-75e7-74225e4f5441 55111-654 HUMAN PRESCRIPTION DRUG Sirolimus Sirolimus TABLET ORAL 20141027 ANDA ANDA201578 Dr. Reddy's Laboratories Limited SIROLIMUS 2 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 55111-659_5e19bb7e-cbbe-e95c-58db-d5d4fb7defe3 55111-659 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201576 Dr. Reddys Laboratories Limited ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55111-661_5e19bb7e-cbbe-e95c-58db-d5d4fb7defe3 55111-661 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201576 Dr. Reddys Laboratories Limited ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55111-662_5e19bb7e-cbbe-e95c-58db-d5d4fb7defe3 55111-662 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201576 Dr. Reddys Laboratories Limited ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55111-663_9cdba353-c828-7ee6-0fed-9eb342df7ffc 55111-663 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140625 ANDA ANDA091412 Dr. Reddy's Laboratories Limited PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 55111-664_9cdba353-c828-7ee6-0fed-9eb342df7ffc 55111-664 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140625 ANDA ANDA091412 Dr. Reddy's Laboratories Limited PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 55111-665_9cdba353-c828-7ee6-0fed-9eb342df7ffc 55111-665 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20140625 ANDA ANDA091412 Dr. Reddy's Laboratories Limited PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 55111-671_d8e2a5fd-2f60-0332-cd9e-099caac44b49 55111-671 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA091023 Dr.Reddy's Laboratories Limited CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 55111-678_8de82d3e-35a8-19f4-ec5b-7aaa40015609 55111-678 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium Fondaparinux Sodium INJECTION SUBCUTANEOUS 20110714 ANDA ANDA091316 Dr. Reddy's Laboratories Limited FONDAPARINUX SODIUM 2.5 mg/.5mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 55111-679_8de82d3e-35a8-19f4-ec5b-7aaa40015609 55111-679 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium Fondaparinux Sodium INJECTION SUBCUTANEOUS 20110714 ANDA ANDA091316 Dr. Reddy's Laboratories Limited FONDAPARINUX SODIUM 5 mg/.4mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 55111-680_8de82d3e-35a8-19f4-ec5b-7aaa40015609 55111-680 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium Fondaparinux Sodium INJECTION SUBCUTANEOUS 20110714 ANDA ANDA091316 Dr. Reddy's Laboratories Limited FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 55111-681_8de82d3e-35a8-19f4-ec5b-7aaa40015609 55111-681 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium Fondaparinux Sodium INJECTION SUBCUTANEOUS 20110714 ANDA ANDA091316 Dr. Reddy's Laboratories Limited FONDAPARINUX SODIUM 10 mg/.8mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 55111-682_756f3fec-d3ca-ad22-4649-ede2af43a9b5 55111-682 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Dr. Reddy's Laboratories Limited IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55111-683_756f3fec-d3ca-ad22-4649-ede2af43a9b5 55111-683 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Dr. Reddy's Laboratories Limited IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55111-684_756f3fec-d3ca-ad22-4649-ede2af43a9b5 55111-684 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Dr. Reddy's Laboratories Limited IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55111-685_aaba38c1-20da-f2b1-0f04-a829a80c6bfa 55111-685 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130304 ANDA ANDA091186 Dr. Reddy's Laboratories Limited ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 55111-686_a829aa8d-1b6a-e7f9-16b2-124f5baa1d11 55111-686 HUMAN PRESCRIPTION DRUG gemcitabine gemcitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA091365 Dr. Reddy's Laboratories Limited GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 55111-687_a829aa8d-1b6a-e7f9-16b2-124f5baa1d11 55111-687 HUMAN PRESCRIPTION DRUG gemcitabine gemcitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA091365 Dr. Reddy's Laboratories Limited GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 55111-688_533307de-bf64-bf20-ef83-21cabf56cfb9 55111-688 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20130403 ANDA ANDA091363 Dr.Reddy's Laboratories Ltd ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 55111-693_1686b69a-0d46-f9a6-3a3d-7788713cbc6f 55111-693 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate INJECTION SUBCUTANEOUS 20140224 ANDA ANDA090495 Dr. Reddy's Laboratories Limited SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 55111-695_279b92ac-8e31-4b04-8983-6f161f5b709c 55111-695 HUMAN PRESCRIPTION DRUG GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET ORAL 20090630 ANDA ANDA079009 Dr. Reddy's Laboratories Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55111-696_279b92ac-8e31-4b04-8983-6f161f5b709c 55111-696 HUMAN PRESCRIPTION DRUG GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET ORAL 20090630 ANDA ANDA079009 Dr. Reddy's Laboratories Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55111-697_279b92ac-8e31-4b04-8983-6f161f5b709c 55111-697 HUMAN PRESCRIPTION DRUG GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET ORAL 20090630 ANDA ANDA079009 Dr. Reddy's Laboratories Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55111-699_7136a472-c852-a4a1-9e11-c8dcb8b14a1f 55111-699 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20080115 ANDA ANDA078343 Dr.Reddy's Laboratories Limited CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55111-717_873e3cd8-700a-4bea-f943-d84bb6e5ff69 55111-717 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20130620 ANDA ANDA202383 Dr.Reddy's Laboratories Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-718_873e3cd8-700a-4bea-f943-d84bb6e5ff69 55111-718 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20130620 ANDA ANDA202383 Dr.Reddy's Laboratories Limited LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-719_873e3cd8-700a-4bea-f943-d84bb6e5ff69 55111-719 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20130620 ANDA ANDA202383 Dr.Reddy's Laboratories Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-720_873e3cd8-700a-4bea-f943-d84bb6e5ff69 55111-720 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20130620 ANDA ANDA202383 Dr.Reddy's Laboratories Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55111-725_81dd061b-5e16-8258-92ab-e972ffade75b 55111-725 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, COATED ORAL 20120806 ANDA ANDA201582 Dr.Reddy's Laboratories Limited MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 55111-727_5e19bb7e-cbbe-e95c-58db-d5d4fb7defe3 55111-727 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201576 Dr. Reddys Laboratories Limited ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55111-728_5e19bb7e-cbbe-e95c-58db-d5d4fb7defe3 55111-728 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120606 ANDA ANDA201576 Dr. Reddys Laboratories Limited ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55111-729_f33bb6f9-b050-767b-7db5-f1c907e9686d 55111-729 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20091001 ANDA ANDA071586 Dr. Reddy's Laboratories Limited ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 55111-730_f33bb6f9-b050-767b-7db5-f1c907e9686d 55111-730 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20091001 ANDA ANDA071587 Dr. Reddy's Laboratories Limited ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 55111-739_72cd1417-804f-bcbd-9964-47d7f8ff1804 55111-739 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202194 Dr. Reddy's Laboratories Limited LANSOPRAZOLE 15 mg/1 N 20181231 55111-762_8fe15177-e938-f69a-26c4-87a6ef4fec18 55111-762 HUMAN PRESCRIPTION DRUG Valganciclovir Valganciclovir TABLET, FILM COATED ORAL 20141215 ANDA ANDA203511 Dr. Reddy's Laboratories Limited VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 55111-763_5330aadc-1ce6-9694-3ad7-dc276a9b3ae4 55111-763 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium GRANULE ORAL 20120920 ANDA ANDA202906 Dr.Reddy's Laboratories Limited MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 55111-784_9a2f5c78-936a-00cb-aba8-89fe0a8422f2 55111-784 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET ORAL 20110103 ANDA ANDA076502 Dr. Reddy's Laboratories Limited FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 55111-789_2983185b-f6d6-ad00-5c86-2db1a2af4d26 55111-789 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate Sevelamer Carbonate TABLET, FILM COATED ORAL 20170929 ANDA ANDA206094 DR. REDDY'S LABORATORIES LIMITED SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 55111-798_b522b17c-2865-ef4b-376b-fd9992b1ac50 55111-798 HUMAN OTC DRUG Guaifenesin and Pseudoephedrine HCL Guaifenesin and Pseudoephedrine HCL TABLET, EXTENDED RELEASE ORAL 20171229 ANDA ANDA208369 Dr. Reddys Laboratories Limited GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20191231 55111-799_b522b17c-2865-ef4b-376b-fd9992b1ac50 55111-799 HUMAN OTC DRUG Guaifenesin and Pseudoephedrine HCL Guaifenesin and Pseudoephedrine HCL TABLET, EXTENDED RELEASE ORAL 20171229 ANDA ANDA208369 Dr. Reddys Laboratories Limited GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 1200; 120 mg/1; mg/1 N 20191231 55115-2041_271a251e-d256-40f3-8a4a-df9c4a8e485a 55115-2041 HUMAN OTC DRUG aloevella Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20111114 OTC MONOGRAPH FINAL part352 Ojas Enterprises LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 15 g/100g; g/100g E 20171231 55118-205_91c0597d-3805-4005-8e15-0d23c5513c90 55118-205 HUMAN OTC DRUG Scott Clear Antibacterial Skin Cleanser Triclosan SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation TRICLOSAN .25 g/100mL E 20171231 55118-225_05d607ad-4023-445e-96ad-9369383704fb 55118-225 HUMAN OTC DRUG Scott Antibacterial Skin Cleanser Chloroxylenol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation CHLOROXYLENOL .5 g/100mL E 20171231 55118-235_bfba27c3-e023-4fed-94d4-5f31b559e269 55118-235 HUMAN OTC DRUG SCOTT Antimicrobial Foam Benzalkonium Chloride SOLUTION TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation BENZALKONIUM CHLORIDE 1 mg/1000mL E 20171231 55118-245_8022ee20-61f7-4ecc-b2b6-ae1140d8e7d9 55118-245 HUMAN OTC DRUG Scott Antiseptic Skin Cleanser Chloroxylenol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation CHLOROXYLENOL 1.25 g/100mL E 20171231 55118-305_5192acfe-022f-40b0-b0d7-8387c0495bcf 55118-305 HUMAN OTC DRUG Kleenex Instant Hand Sanitizer Alcohol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 62 mL/100mL E 20171231 55118-325_7b3d17bd-13ab-4dca-a9e2-bb08797adaff 55118-325 HUMAN OTC DRUG Scott Moisturizing Instant Hand Sanitizer Alcohol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 62 mL/100mL E 20171231 55118-425_20f76305-63fd-4aa3-abc6-d27ed47f76ea 55118-425 HUMAN OTC DRUG Scott Antibacterial Triclosan SOLUTION TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation TRICLOSAN 5 g/L E 20171231 55118-440_a12a5460-496b-4d3e-ae66-8375f8a13a5f 55118-440 HUMAN OTC DRUG KLEENEX Antimicrobial Skin Cleanser Benzalkonium Chloride SOLUTION TOPICAL 20130620 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation BENZALKONIUM CHLORIDE .013 mg/L E 20171231 55118-480_da87db9e-c6bc-4019-9d92-bda7b12925e1 55118-480 HUMAN OTC DRUG Kleenex Moisturizing Instant Hand Sanitizer Alcohol SOLUTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 62 mL/100mL E 20171231 55118-530_eeb3a137-765c-4cb0-b49f-2b8c43a36e6b 55118-530 HUMAN OTC DRUG Kleenex Ultra Moisturizing Hand Sanitizer Alcohol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 70 mL/100mL E 20171231 55118-535_535baf12-fb0d-4c3a-a399-f33f9df6e30f 55118-535 HUMAN OTC DRUG Kleenex Hand Sanitizer, Green Certified Alcohol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 70 mL/100mL E 20171231 55118-545_5731b33e-1dff-4c35-b0cd-485b4c60fe0a 55118-545 HUMAN OTC DRUG Kleenex Moisturizing Hand Sanitizer, Hydrates Skin Alcohol SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 62 mL/100mL E 20171231 55118-550_5a67855f-5885-49b1-a2a9-6f4424972fd7 55118-550 HUMAN OTC DRUG Kleenex Antibacterial Skin Cleanser Fragrance Free Benzalkonium Chloride SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation BENZALKONIUM CHLORIDE 1.3 g/L E 20171231 55118-555_84c49371-c5e7-4301-8156-1bf01d1d6d8b 55118-555 HUMAN OTC DRUG Scott Triclosan Free Antibacterial Skin Cleanser Benzalkonium Chloride SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation BENZALKONIUM CHLORIDE .13 g/100mL E 20171231 55118-560_44c2c832-1f16-4a6e-9fce-a83c33ec7b1e 55118-560 HUMAN OTC DRUG Kleenex Antibacterial Skin Cleanser Benzalkonium Chloride SOLUTION TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation BENZALKONIUM CHLORIDE 1.3 g/L E 20171231 55118-565_5c76fdc5-f0e6-42bf-a8c2-92a539a78d9c 55118-565 HUMAN OTC DRUG KLEENEX Antibacterial Skin Cleanser Triclosan SOLUTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation TRICLOSAN 5 g/L E 20171231 55118-570_fad5278b-c6a5-4c95-9c9d-795079d116cd 55118-570 HUMAN OTC DRUG KLEENEX E2 Foam Skin Cleanser Chloroxylenol SOLUTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation CHLOROXYLENOL .0175 L/L E 20171231 55118-571_16106482-7231-4892-bee9-83a4f34443f8 55118-571 HUMAN OTC DRUG Kleenex Antiseptic Skin Cleanser Chloroxylenol SOLUTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation CHLOROXYLENOL 17.5 g/L E 20171231 55118-575_448e57af-ad75-41e9-b0aa-70520a9a7292 55118-575 HUMAN OTC DRUG KLEENEX Antibacterial Skin Cleanser Triclosan SOLUTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation TRICLOSAN 2.5 g/L E 20171231 55118-580_285498ea-7457-4aa6-9076-f462fa009c4f 55118-580 HUMAN OTC DRUG KLEENEX Antiseptic Hand Rub with Moisturizers Alcohol SOLUTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL .7 L/L E 20171231 55118-600_858ce55b-2916-4778-bbfd-9e88cbb81c11 55118-600 HUMAN OTC DRUG Sunscreen Mango and Coconut Avobenzone, Octinoxate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100315 OTC MONOGRAPH NOT FINAL part352 Kimberly-Clark Corporation AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 10; 75; 50; 8; 50 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 55118-605_33f8bb1a-8b58-4f69-b65c-6b31d9903887 55118-605 HUMAN OTC DRUG Truist Sunscreen Moisturizer Avobenzone, HOMOSALATE, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130620 OTC MONOGRAPH NOT FINAL part352 Kimberly-Clark Corporation AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 27; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55118-610_05132d26-2d7a-4c1a-8f85-b500a1b63fde 55118-610 HUMAN OTC DRUG KLEENEX Hand Sanitizer Alcohol SOLUTION TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation ALCOHOL 70 mL/100mL E 20171231 55118-700_3260092a-f7f2-4633-a184-637c9a43b392 55118-700 HUMAN OTC DRUG KLEENEX Antimicrobial Foam Skin Cleanser Benzalkonium Chloride SOLUTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation BENZALKONIUM CHLORIDE 1 mg/1000mL E 20171231 55118-701_5de409be-c506-4a51-bc7e-aaab8bdf93f4 55118-701 HUMAN OTC DRUG KLEENEX Foam Hand Sanitizer Benzalkonium Chloride SOLUTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part333E Kimberly-Clark Corporation BENZALKONIUM CHLORIDE 1.3 mg/1000mL E 20171231 55118-978_92ff7ac3-430e-44fa-a1ff-fabce48235b2 55118-978 HUMAN PRESCRIPTION DRUG Kimvent Oral Care Q2 Kit with CHG Hydrogen peroxide and Chlorhexidine Gluconate KIT 19960507 ANDA ANDA074356 Halyard Health N 20181231 55118-980_b15d54ed-88f3-4a48-82d2-c807d9bc51e7 55118-980 HUMAN OTC DRUG Kimvent Oral Care Toothbrush pack Cetylpyridinium Chloride KIT 20080313 OTC MONOGRAPH NOT FINAL part356 Halyard Health N 20181231 55118-990_99013438-0486-476a-80b3-97bfc717e90d 55118-990 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID ORAL 20080826 OTC MONOGRAPH NOT FINAL part356 Halyard Health HYDROGEN PEROXIDE .015 mg/mL N 20181231 55118-993_99013438-0486-476a-80b3-97bfc717e90d 55118-993 HUMAN OTC DRUG Kimvent Oral Care Suction Swab pack Hydrogen Peroxide KIT 20080826 OTC MONOGRAPH NOT FINAL part356 Halyard Health N 20181231 55127-001_4520a8d2-28ed-48c4-9b58-f42eb766a744 55127-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20141201 NDA NDA205840 Thumb Welding Supplies Inc OXYGEN 99 L/100L N 20191231 55128-001_dd0aead9-2da1-4a18-8d6e-e702c0b7be45 55128-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS Terre Haute Home Health Care Products dba Anderson's Medical Products OXYGEN 99 L/100L N 20181231 55133-010_820d2b2e-c813-4830-9883-4abb6d17373c 55133-010 HUMAN OTC DRUG Snail Aqua EGF Sleep Witch Hazel, Dimethicone CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 HANBANGMEIN COSMETICS WITCH HAZEL; DIMETHICONE .3; .3 mg/30mL; mg/30mL N 20181231 55133-020_7488b30d-faca-47d1-a40c-2b7e4c0f6e88 55133-020 HUMAN OTC DRUG EGF Premium Antiaging Eye Dimethicone, Allantoin CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 HANBANGMEIN COSMETICS DIMETHICONE; ALLANTOIN .3; .15 mg/30mL; mg/30mL N 20181231 55133-030_114410d7-da78-4369-aa8f-050e2da49521 55133-030 HUMAN OTC DRUG EGF Premium Antiaging Special Dimethicone, Allantoin CREAM TOPICAL 20121001 OTC MONOGRAPH FINAL part347 HANBANGMEIN COSMETICS DIMETHICONE; ALLANTOIN .5; .25 mg/50mL; mg/50mL N 20181231 55133-040_43e5ae94-bada-4d01-a6ff-19482e9cf6e3 55133-040 HUMAN OTC DRUG EGF Premium Whitening Milk Dimethicone, Allantoin LOTION TOPICAL 20121001 OTC MONOGRAPH FINAL part347 HANBANGMEIN COSMETICS DIMETHICONE; ALLANTOIN 1.5; .75 mg/150mL; mg/150mL N 20181231 55133-050_86a26c66-a17c-4f52-99bf-8ca2f7aa96d6 55133-050 HUMAN OTC DRUG EGF Premium Whitening Skin Allantoin LOTION TOPICAL 20121001 OTC MONOGRAPH FINAL part347 HANBANGMEIN COSMETICS ALLANTOIN .75 mg/150mL N 20181231 55138-001_f94f554a-7a96-4039-bd0b-4c7d45d4598c 55138-001 HUMAN OTC DRUG Brain Power Semecarpus Anacardium Juice, Arnica Montana, Calcium Fluoride, Silybum Marianum Seed, Cinchona Officinalis Bark, Herring Sperm DNA, Ginkgo, Egg Phospholipids, Achillea Millefolium, Phosphoric Acid, Saccharomyces Cerevisia RNA, Silicon Dioxide, and Zinc Sulphate Heptahydrate SPRAY ORAL 20131113 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. SEMECARPUS ANACARDIUM JUICE; ARNICA MONTANA; CALCIUM FLUORIDE; SILYBUM MARIANUM SEED OIL; CINCHONA OFFICINALIS BARK; HERRING SPERM DNA; GINKGO; EGG PHOSPHOLIPIDS; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID; SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE; ZINC SULFATE HEPTAHYDRATE 30; 1.5; 30; 1.5; 3; 3; 3; 6; 1.5; 30; 6; 6; 6 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 55138-003_57497b7c-cf97-4b11-82b6-50c3961fbd01 55138-003 HUMAN OTC DRUG Immune Booster Apis Mellifera, Baptisia Tinctoria, Silybum Marianum Seed, Herring Sperm DNA, Echinacea, Galium Aparine, Mercuric Chloride, Mercuric Sulfide, Nitric Acid, Sulfur Iodide, and Thuja Occidentalis Leafy Twig SPRAY ORAL 20131113 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. APIS MELLIFERA; BAPTISIA TINCTORIA; SILYBUM MARIANUM SEED OIL; HERRING SPERM DNA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; MERCURIC CHLORIDE; MERCURIC SULFIDE; NITRIC ACID; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG 200; 3; 1.5; 3; 3; 1.5; 200; 30; 30; 200; 200 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 55138-004_3abef54c-4f7c-4b61-8ed2-0a1627f3b20c 55138-004 HUMAN OTC DRUG Heartery American Ginseng, Arnica Montana, Gold, Barium Carbonate, Atropa Belladonna, Calcium Fluoride, Cholesterol, Herring Sperm DNA, Ginkgo, Saccharomyces Cerevisia RNA, Visbum Album Fruiting Top, and Ginger SPRAY ORAL 20131118 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. AMERICAN GINSENG; ARNICA MONTANA; GOLD; BARIUM CARBONATE; ATROPA BELLADONNA; CALCIUM FLUORIDE; CHOLESTEROL; HERRING SPERM DNA; GINKGO; SACCHAROMYCES CEREVISIAE RNA; VISCUM ALBUM FRUITING TOP; GINGER 1; 1.5; 30; 30; 3; 6; 15; 3; 3; 3; 1.5; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 55138-005_639874bb-c53d-40f1-bedb-4e8dcc84391e 55138-005 HUMAN OTC DRUG Diabetigen Arnica Montana, Arsenic Trioxide, Herring Sperm NDA, Echinacea, Unspecified, Hamamelis Virginiana Leaf, Chamaelirium Luteum Root, Pork Liver, Iris Versicolor Root, Sus Scrofa Pancreas, Phosphoric Acid, Rosmarinus Officinalis Flowering Top, Claviceps Purpurea Sclerotium, Syzygium Cumini Seed, and Uranyl Nitrate Hexahydrate SPRAY ORAL 20131118 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. ARNICA MONTANA; ARSENIC TRIOXIDE; HERRING SPERM DNA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA LEAF; CHAMAELIRIUM LUTEUM ROOT; PORK LIVER; IRIS VERSICOLOR ROOT; SUS SCROFA PANCREAS; PHOSPHORIC ACID; ROSMARINUS OFFICINALIS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 1.5; 200; 3; 1.5; 1.5; 1.5; 3; 3; 3; 200; 1.5; 30; 1.5; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 55138-006_7ff867c7-85a7-4222-a4b9-dff98bd4ec5e 55138-006 HUMAN OTC DRUG Brain Power Semecarpus Anacardium Juice, Arnica Montana, Calcium Fluoride, Silybum Marianum Seed, Chincona Officinalis Bark, Herring Sperm DNA, Ginkgo, Egg Phospholipids, Achillea Millefolium, Phosphoric Acid, Saccharomyces Cerevisia RNA, Silicon Dioxide, and Zinc Sulphate Heptahydrate SPRAY ORAL 20131118 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. SEMECARPUS ANACARDIUM JUICE; ARNICA MONTANA; CALCIUM FLUORIDE; SILYBUM MARIANUM SEED OIL; CINCHONA OFFICINALIS BARK; HERRING SPERM DNA; GINKGO; EGG PHOSPHOLIPIDS; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID; SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE; ZINC SULFATE HEPTAHYDRATE 30; 1.5; 30; 1.5; 3; 3; 3; 6; 1.5; 30; 6; 6; 6 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 55138-007_bba3f011-32e9-4c36-abad-d2f1630d31c8 55138-007 HUMAN OTC DRUG Livergen Arnica Montana, Byronia Alba Root, Silybum Marianum Seed, Chelidonium Majus, Herring Sperm DNA, Pork Liver, Cervus Elaphus Horn Oil, Sus Scrofa Pancreas, and Taraxacum Officinale SPRAY ORAL 20131113 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. ARNICA MONTANA; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED OIL; CHELIDONIUM MAJUS; HERRING SPERM DNA; PORK LIVER; CERVUS ELAPHUS HORN OIL; SUS SCROFA PANCREAS; TARAXACUM OFFICINALE 1.5; 200; .5; 200; 3; 3; 4; 4; 1 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 55138-011_09714392-eccb-4123-a8f5-56f9d04009f3 55138-011 HUMAN OTC DRUG Lung Detox silver nitrate, arsenic trioxide, activated charcoal, silybum marianum seed, herring sperm DNA, pork liver, mercuric chloride, lead SPRAY ORAL 20140808 UNAPPROVED HOMEOPATHIC Integra Health International S.A. de C.V. SILVER NITRATE; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; SILYBUM MARIANUM SEED; HERRING SPERM DNA; PORK LIVER; MERCURIC CHLORIDE; LEAD 200; 200; 200; .5; 3; 3; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg E 20171231 55138-012_9cd1c9c0-ab97-408a-b64e-aabab0bf00cc 55138-012 HUMAN OTC DRUG Female Energy Chaste Tree, Arnica Montana, Caulophyllum Thalictroides Root, Cinchona Officinalis Bark, Turnera Diffusa Leafy Twig, Herring Sperm DNA, Lactuca Virosa, Onosmodium Virginianum Whole, Sus Scrofa Ovary, Phosphoric Acid, Sus Scrofa Pituitary Gland, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig SPRAY ORAL 20140807 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. CHASTE TREE; ARNICA MONTANA; CAULOPHYLLUM THALICTROIDES ROOT; CINCHONA OFFICINALIS BARK; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; LACTUCA VIROSA; ONOSMODIUM VIRGINIANUM WHOLE; SUS SCROFA OVARY; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 1.5; 1.5; 3; 1.5; .5; 3; 1.5; 30; 30; 200; 6; 30; 30 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg E 20171231 55138-013_0d9732a5-d779-4afa-bdeb-f2d261ab474b 55138-013 HUMAN OTC DRUG Male Tonicity american ginseng, arnica montana, turnera diffusa leafy twig, herring sperm DNA, galium aparine, hamamelis virginiana root bark/stem bark, pork liver, cervus elaphus horn oil, ovis aries testicle, phosphoric acid, sus scrofa pituitary gland, thuja occidentalis leafy twig, thyroid, unspecified, tribulus terrestris, ginger SPRAY ORAL 20140808 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. AMERICAN GINSENG; ARNICA MONTANA; TURNERA DIFFUSA LEAFY TWIG; HERRING SPERM DNA; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; CERVUS ELAPHUS HORN OIL; OVIS ARIES TESTICLE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRIBULUS TERRESTRIS; GINGER 1.5; 1.5; 1; 3; 1.5; 1.5; 3; 4; 3; 200; 4; 1.5; 6; 1; 1.5 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg E 20171231 55138-015_78f4cd01-d1c0-4993-911b-273749eeda55 55138-015 HUMAN OTC DRUG Air Detox argentum nitricum, arsenicum album, carduus marianus, hepar suis, mercurius corrosivus, plumbum metallicum SPRAY ORAL 20150609 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. SILVER NITRATE; ARSENIC TRIOXIDE; MILK THISTLE; PORK LIVER; MERCURIC CHLORIDE; LEAD 200; 200; 1; 6; 200; 200 [hp_C]/28g; [hp_C]/28g; [hp_X]/28g; [hp_X]/28g; [hp_C]/28g; [hp_C]/28g E 20171231 55138-016_642e02d3-5041-4e6c-ae24-d0ee33efef09 55138-016 HUMAN OTC DRUG Metals Detox alumina, arsenicum metallicum, mercurius corrosivus, niccolum metallicum, plumbum metallicum, radium bromatum, stannum metallicum SPRAY ORAL 20150609 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. ALUMINUM OXIDE; ARSENIC; MERCURIC CHLORIDE; NICKEL; LEAD; RADIUM BROMIDE; TIN 30; 30; 30; 30; 30; 30; 30 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g E 20171231 55138-017_6cb07999-66a1-4ede-9dc8-4b5f14b01123 55138-017 HUMAN OTC DRUG Tabakfre Equal amounts of each HPUS ingredient in 30C, 200C, 1M, LM1, LM2, LM3, LM4, and LM5 potencies SOLUTION ORAL 20150910 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. ACONITUM NAPELLUS; .ALPHA.-LIPOIC ACID, (+/-)-; AGRIMONIA EUPATORIA FLOWER; AMMONIA; AMMONIUM CARBONATE; ANTIMONY ARSENATE; ANTIMONY POTASSIUM TARTRATE; ANTIMONY TRISULFIDE; ARABICA COFFEE BEAN; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; ATROPA BELLADONNA; AVENA SATIVA FLOWERING TOP; BOS TAURUS HYPOTHALAMUS; BROMINE; CALCIUM IODIDE; CAPSICUM; CARBON DISULFIDE; CARBON MONOXIDE; CHELIDONIUM MAJUS; CHLORINE; CHLOROFORM; CINCHONA OFFICINALIS BARK; COENZYME A; CONIUM MACULATUM FLOWERING TOP; CORTICOTROPIN; DAPHNE ODORA BARK; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; ECHINACEA PURPUREA; EPINEPHRINE; ESCHSCHOLZIA CALIFORNICA; FORMALDEHYDE; GLYCYRRHIZA GLABRA; GOLDENSEAL; HELIANTHUS ANNUUS FLOWERING TOP; HERRING SPERM DNA; HOPS; HORSE CHESTNUT; HYPERICUM PERFORATUM; JUGLANS REGIA FLOWERING TOP; JUNIPERUS COMMUNIS WHOLE; LEAD; LIQUID PETROLEUM; LOBARIA PULMONARIA; LOBELIA INFLATA; LONICERA PERICLYMENUM FLOWERING TWIG; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; MERCURY; NICOTINE; OXOGLURIC ACID; PASSIFLORA INCARNATA FLOWERING TOP; PHENOL; PHYTOLACCA AMERICANA ROOT; PICEA MARIANA RESIN; PLANTAGO MAJOR; POTASSIUM CARBONATE; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA PRATENSIS; RICINUS COMMUNIS SEED; SCROPHULARIA NODOSA; SEMECARPUS ANACARDIUM JUICE; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUCROSE; SULFUR IODIDE; SULFURIC ACID; SUS SCROFA PITUITARY GLAND; SYZYGIUM JAMBOS SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TIN; TOBACCO LEAF; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; [hp_C]/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL E 20171231 55138-018_334d922f-96df-4bb1-e054-00144ff8d46c 55138-018 HUMAN PRESCRIPTION DRUG 20Lighter Crave Control 20L-A Peptides 20L-B Peptides Acetyl coenzyme A adenosinum triphosphoricum dinatrum adrenal cotex suis agnus castus aldosterone anacardium orientale androsterone antimonium crudum apiol argentum nitricum ATP bacopa speciosa berberis vulgaris bryonia cedron chamomilla chininum sulphuricum cholesterinum cimicifugaracemosa cina LIQUID ORAL 20160307 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. DATURA STRAMONIUM; TESTOSTERONE; THYROID, UNSPECIFIED; VALERIAN; VIOLA ODORATA; APIOLE (PARSLEY); PHOSPHORUS; PROGESTERONE; ANEMONE PATENS; RHODIOLA KIRILOWII WHOLE; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SENNA LEAF; SEPIA OFFICINALIS JUICE; ESTRONE; FOLLITROPIN; GAMBOGE; CHAMAELIRIUM LUTEUM ROOT; HUMULUS LUPULUS POLLEN; STRYCHNOS IGNATII SEED; IODINE; LACHESIS MUTA WHOLE; LEDUM PALUSTRE TWIG; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MENTHA PIPERITA; SULFUR; ACETYL COENZYME A; .ALPHA.-TOCOPHEROL; CHASTE TREE; ALDOSTERONE; SEMECARPUS ANACARDIUM JUICE; ANDROSTERONE; SILVER NITRATE; ARTEMISIA CINA FLOWER; EQUOL, (+)-; HYDRASTIS CANADENSIS WHOLE; ADENOSINE TRIPHOSPHATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; SIMABA CEDRON SEED; QUININE SULFATE; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CINNAMOMUM CAMPHORA WHOLE; CONVALLARIA MAJALIS; CORTISONE ACETATE; CROCUS SATIVUS FLOWER; CYCLAMEN PURPURASCENS TUBER; PRASTERONE; MATRICARIA CHAMOMILLA FLOWERING TOP OIL; BLACK COHOSH; GRAPHITE; NAJA NAJA VENOM; ALCALIGENES FAECALIS; ANTIMONY TRISULFIDE; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA OVARY; TIN; DELPHINIUM STAPHISAGRIA SEED 15; 8; 6; 3; 3; 6; 6; 8; 15; 6; 15; 3; 3; 4; 8; 12; 6; 3; 15; 4; 6; 12; 3; 4; 6; 3; 4; 6; 6; 4; 12; 15; 12; 15; 3; 6; 3; 6; 15; 6; 4; 6; 6; 3; 12; 3; 12; 3; 3; 6; 3; 3; 15; 12; 30; 15; 12; 15; 15; 8; 12; 4 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient],Progesterone [Chemical/Ingredient],Progesterone [EPC],Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient],Antimalarial [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 55138-019_334d922f-96e3-4bb1-e054-00144ff8d46c 55138-019 HUMAN PRESCRIPTION DRUG 20 Lighter Fat Burner 20L-A PEPTIDES LIQUID ORAL 20160222 UNAPPROVED HOMEOPATHIC Integra Health International, S.A. de C.V. SUS SCROFA CEREBRUM; SHIGELLA DYSENTERIAE; ECHINACEA ANGUSTIFOLIA; SUS SCROFA EYE; SUS SCROFA HYPOTHALAMUS; PORK INTESTINE; SUS SCROFA JEJUNUM; MANDRAGORA OFFICINARUM ROOT; PROTEUS INCONSTANS; PORK KIDNEY; SUS SCROFA STOMACH; GAMBOGE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TARAXACUM OFFICINALE; WOOD CREOSOTE; SUS SCROFA BILE DUCT; GRAPHITE; GLYOXAL; GELSEMIUM SEMPERVIRENS ROOT; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; SUS SCROFA COLON; .ALPHA.-KETOGLUTARIC ACID; SEMECARPUS ANACARDIUM JUICE; .ALPHA.-LIPOIC ACID; BELLADONNA LEAF; EQUOL, (+)-; SUS SCROFA ESOPHAGUS; FORMIC ACID; SUS SCROFA GALLBLADDER; INSULIN ARGINE; SULFUR; HUMAN THYMUS; SUS SCROFA URINARY BLADDER; VERATRUM ALBUM ROOT; CYNANCHUM VINCETOXICUM ROOT; PORK LIVER; CARAPICHEA IPECACUANHA WHOLE; LYCOPODIUM CLAVATUM WHOLE; YEAST MANNAN; MENADIONE; METHYLCOBALAMIN; MOMORDICA BALSAMINA WHOLE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SUS SCROFA DUODENUM; HYDRASTIS CANADENSIS WHOLE; SUS SCROFA ILEUM; LACHESIS MUTA VENOM; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; PULSATILLA VULGARIS; LACTIC ACID, L-; ADENOSINE TRIPHOSPHATE; AVENA SATIVA FLOWERING TOP; MILK THISTLE; CHELIDONIUM MAJUS; CHOLESTEROL; GLUCAGON; SILVER NITRATE; MARSDENIA CUNDURANGO WHOLE; CYNARA SCOLYMUS LEAF 8; 30; 8; 8; 6; 8; 8; 10; 30; 8; 8; 12; 12; 4; 10; 8; 60; 10; 60; 4; 4; 8; 10; 8; 6; 10; 8; 8; 10; 8; 30; 13; 8; 6; 4; 6; 8; 8; 4; 10; 6; 8; 8; 60; 8; 8; 8; 60; 6; 4; 8; 10; 10; 8; 6; 30; 30; 6; 3; 4; 10; 30; 6; 6; 6 [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Antihypoglycemic Agent [EPC],Gastrointestinal Motility Inhibitor [EPC],Increased Gluconeogenesis [PE],Increased Glycogenolysis [PE],Decreased GI Smooth Muscle Tone [PE],Decreased GI Motility [PE],Decreased Glycolysis [PE] E 20171231 55143-009_e15e630d-49b1-404a-916d-53aae6888e6a 55143-009 HUMAN OTC DRUG BIRDS GARDEN LIP BALM CERULEAN WARBLER SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 7.5; 7; 5; 5 g/100g; g/100g; g/100g; g/100g E 20171231 55143-010_9260c289-54ae-4eaf-b8f4-376959804993 55143-010 HUMAN OTC DRUG BIRDS GARDEN LIP BALM WESTERN TANAGER - SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 7.5; 7; 5; 5 g/100g; g/100g; g/100g; g/100g E 20171231 55143-011_aa841284-14ed-4308-9569-925f6bce9e7a 55143-011 HUMAN OTC DRUG BIRDS GARDEN LIP BALM DARK EYED JUNCO SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 7.5; 7; 5; 5 g/100g; g/100g; g/100g; g/100g E 20171231 55143-012_d23998ec-a3e9-4765-9a35-82216333c531 55143-012 HUMAN OTC DRUG Lip Remedy Medicinal Lip Balm BLUE PETROLATUM STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part346 Norwood Packaging Ltd. PETROLATUM 32.3 g/100g E 20171231 55143-013_d23998ec-a3e9-4765-9a35-82216333c531 55143-013 HUMAN OTC DRUG Lip Remedy Medicinal Lip Balm GREEN PETROLATUM STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part346 Norwood Packaging Ltd. PETROLATUM 32.3 g/100g E 20171231 55143-014_d23998ec-a3e9-4765-9a35-82216333c531 55143-014 HUMAN OTC DRUG Lip Remedy Medicinal Lip Balm RED PETROLATUM STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part346 Norwood Packaging Ltd. PETROLATUM 32.3 g/100g E 20171231 55143-100_0d70e74f-76a1-4b7a-aa48-56301c458ea5 55143-100 HUMAN OTC DRUG Badger Lavender SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 18.75 g/100mL E 20171231 55143-101_901c54cd-c747-4dda-9a1d-f55b7e36def0 55143-101 HUMAN OTC DRUG Badger SPF 35 All Season Face ZINC OXIDE STICK TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 22.5 g/100g E 20171231 55143-102_4306291a-c8ea-4dd4-94a3-fb7ee261704b 55143-102 HUMAN OTC DRUG Badger Unscented SPF 15 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 10 g/100mL E 20171231 55143-103_40043922-9aaf-4aac-983a-a20224ab6da3 55143-103 HUMAN OTC DRUG Badger SPF 34 Anti-Bug Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 20 g/100mL E 20171231 55143-104_85e433f0-2da5-4638-a31e-78c1cab56950 55143-104 HUMAN OTC DRUG Badger Unscented SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 18.75 g/100mL E 20171231 55143-105_17306c4f-fc16-463c-82e9-e47839c03ecd 55143-105 HUMAN OTC DRUG Badger Baby SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 18.75 g/100mL E 20171231 55143-106_3ea8daa1-1221-46a4-afaf-2675d6b13876 55143-106 HUMAN OTC DRUG Badger Sport SPF 35 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 22.5 g/100mL E 20171231 55143-107_014285da-cd1b-484a-a259-dcd787233cbe 55143-107 HUMAN OTC DRUG Badger Kids SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 18.75 g/100mL E 20171231 55143-108_bd618a66-f9b9-43e9-8b92-b3db631b9067 55143-108 HUMAN OTC DRUG Badger SPF 15 Sunscreen Lip Balm ZINC OXIDE STICK TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Norwood Packaging Ltd. ZINC OXIDE 8 g/100g E 20171231 55147-001_e6d0dab5-4280-4952-9b6a-1dac6f7495b5 55147-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950101 NDA NDA205767 Minneapolis Oxygen Company OXYGEN 990 mL/L N 20181231 55147-002_205000fe-9f4a-4153-b205-7b890c839b89 55147-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19950101 NDA NDA205766 Minneapolis Oxygen Company NITROGEN 990 mL/L N 20181231 55147-004_219668b0-1c17-4766-b86d-c5cdadbdaa35 55147-004 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19950101 NDA NDA205767 Minneapolis Oxygen Company OXYGEN 210 mL/L N 20181231 55150-111_e0d1bc20-f6ef-4e91-a18b-1d4d93ec1e9e 55150-111 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120201 ANDA ANDA065499 AuroMedics Pharma LLC AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55150-112_e0d1bc20-f6ef-4e91-a18b-1d4d93ec1e9e 55150-112 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120201 ANDA ANDA065499 AuroMedics Pharma LLC AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55150-113_e0d1bc20-f6ef-4e91-a18b-1d4d93ec1e9e 55150-113 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120201 ANDA ANDA065499 AuroMedics Pharma LLC AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55150-114_e0d1bc20-f6ef-4e91-a18b-1d4d93ec1e9e 55150-114 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120201 ANDA ANDA065499 AuroMedics Pharma LLC AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55150-115_7ba95b80-c996-4475-af4e-78880652332a 55150-115 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120201 ANDA ANDA065493 AuroMedics Pharma LLC AMPICILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55150-116_24396b86-3078-43e0-89bd-882f3b279692 55150-116 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120210 ANDA ANDA090349 AuroMedics Pharma LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 55150-117_24396b86-3078-43e0-89bd-882f3b279692 55150-117 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120210 ANDA ANDA090349 AuroMedics Pharma LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 55150-118_6f1e5387-4f48-4f93-a46f-308bb3998fce 55150-118 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120210 ANDA ANDA090339 AuroMedics Pharma LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 55150-119_f950f8ae-706a-440a-8a0e-c1a1c000f7cd 55150-119 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin Sodium and Tazobactam Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120123 ANDA ANDA065498 AuroMedics Pharma LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 55150-120_f950f8ae-706a-440a-8a0e-c1a1c000f7cd 55150-120 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin Sodium and Tazobactam Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120123 ANDA ANDA065498 AuroMedics Pharma LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 55150-121_f950f8ae-706a-440a-8a0e-c1a1c000f7cd 55150-121 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin Sodium and Tazobactam Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120123 ANDA ANDA065498 AuroMedics Pharma LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 55150-122_f24d8e50-59e9-44f3-98fc-a3fdbe476c9a 55150-122 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121226 ANDA ANDA091613 AuroMedics Pharma LLC NAFCILLIN SODIUM 1 g/4mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 55150-123_34821770-929c-40ea-a9e4-d4405dc869e1 55150-123 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121226 ANDA ANDA091613 AuroMedics Pharma LLC NAFCILLIN SODIUM 2 g/8mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 55150-123_f24d8e50-59e9-44f3-98fc-a3fdbe476c9a 55150-123 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121226 ANDA ANDA091613 AuroMedics Pharma LLC NAFCILLIN SODIUM 2 g/8mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 55150-124_0f21384c-0f82-4d99-a05c-6773d1ee4bcf 55150-124 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121226 ANDA ANDA091614 AuroMedics Pharma LLC NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 55150-124_9289bf68-1201-450f-a38c-bfc5fb910631 55150-124 HUMAN PRESCRIPTION DRUG Nafcillin Nafcillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20121226 ANDA ANDA091614 AuroMedics Pharma LLC NAFCILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 55150-125_4ccc3260-072f-43d4-9ffb-8572b2519884 55150-125 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121221 ANDA ANDA202600 AuroMedics Pharma LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55150-126_a9ca0080-cb51-4946-b564-ff4caafab1d4 55150-126 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121221 ANDA ANDA202599 AuroMedics Pharma LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55150-127_32fb75a8-5833-4d94-9e53-a982894c4f6f 55150-127 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130118 ANDA ANDA201539 AuroMedics Pharma LLC OXACILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55150-128_110b0fd1-c842-4bab-81eb-4b1d58a746af 55150-128 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130118 ANDA ANDA201539 AuroMedics Pharma LLC OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55150-128_32fb75a8-5833-4d94-9e53-a982894c4f6f 55150-128 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130118 ANDA ANDA201539 AuroMedics Pharma LLC OXACILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55150-129_29816564-3858-4c34-9025-a8bb7a9df21a 55150-129 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin Sodium POWDER, FOR SOLUTION INTRAVENOUS 20130118 ANDA ANDA201538 AuroMedics Pharma LLC OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55150-129_b0a443a8-05d2-44bc-a150-58526b7f05f6 55150-129 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin Sodium POWDER, FOR SOLUTION INTRAVENOUS 20130118 ANDA ANDA201538 AuroMedics Pharma LLC OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55150-154_370af699-a098-4574-958e-1f6d5b60866c 55150-154 HUMAN PRESCRIPTION DRUG Acyclovir Sodium Acyclovir Sodium INJECTION, SOLUTION INTRAVENOUS 20131011 ANDA ANDA203701 AuroMedics Pharma LLC ACYCLOVIR SODIUM 500 mg/10mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55150-154_d3ab226c-677d-4cb7-85cb-1c2e5012f40d 55150-154 HUMAN PRESCRIPTION DRUG Acyclovir Sodium Acyclovir Sodium INJECTION, SOLUTION INTRAVENOUS 20131011 ANDA ANDA203701 AuroMedics Pharma LLC ACYCLOVIR SODIUM 500 mg/10mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55150-155_370af699-a098-4574-958e-1f6d5b60866c 55150-155 HUMAN PRESCRIPTION DRUG Acyclovir Sodium Acyclovir Sodium INJECTION, SOLUTION INTRAVENOUS 20131011 ANDA ANDA203701 AuroMedics Pharma LLC ACYCLOVIR SODIUM 1000 mg/20mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55150-155_d3ab226c-677d-4cb7-85cb-1c2e5012f40d 55150-155 HUMAN PRESCRIPTION DRUG Acyclovir Sodium Acyclovir Sodium INJECTION, SOLUTION INTRAVENOUS 20131011 ANDA ANDA203701 AuroMedics Pharma LLC ACYCLOVIR SODIUM 1000 mg/20mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55150-156_d57e39a2-9919-4290-a1d8-ee96fe07f0c2 55150-156 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130124 ANDA ANDA202328 AuroMedics Pharma LLC LEVOFLOXACIN 500 mg/20mL N 20181231 55150-157_d57e39a2-9919-4290-a1d8-ee96fe07f0c2 55150-157 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130124 ANDA ANDA202328 AuroMedics Pharma LLC LEVOFLOXACIN 750 mg/30mL N 20181231 55150-158_48b975bf-13d2-4d4a-b57e-28e1c0ec012c 55150-158 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203040 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-159_48b975bf-13d2-4d4a-b57e-28e1c0ec012c 55150-159 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203040 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-160_48b975bf-13d2-4d4a-b57e-28e1c0ec012c 55150-160 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203040 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-161_08465e91-f716-4c5d-972c-a20253ada88e 55150-161 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203082 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-162_08465e91-f716-4c5d-972c-a20253ada88e 55150-162 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203082 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-163_08465e91-f716-4c5d-972c-a20253ada88e 55150-163 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203082 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-164_08465e91-f716-4c5d-972c-a20253ada88e 55150-164 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203082 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-165_08465e91-f716-4c5d-972c-a20253ada88e 55150-165 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20130314 ANDA ANDA203082 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-166_b8d9f5d3-b2be-419e-8cb3-1c873068189b 55150-166 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil Citrate INJECTION, SOLUTION INTRAVENOUS 20150401 ANDA ANDA203988 AuroMedics Pharma LLC SILDENAFIL CITRATE 10 mg/12.5mL Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 55150-167_f8ec86f0-0677-40f0-8305-8bb694ffdab5 55150-167 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 20131105 ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-168_f8ec86f0-0677-40f0-8305-8bb694ffdab5 55150-168 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 20131105 ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-169_f8ec86f0-0677-40f0-8305-8bb694ffdab5 55150-169 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INTRACAUDAL 20131105 ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-170_f8ec86f0-0677-40f0-8305-8bb694ffdab5 55150-170 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INTRACAUDAL 20131105 ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-171_f8ec86f0-0677-40f0-8305-8bb694ffdab5 55150-171 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; RETROBULBAR 20131105 ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-172_f8ec86f0-0677-40f0-8305-8bb694ffdab5 55150-172 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; RETROBULBAR 20131105 ANDA ANDA203895 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-173_2877a406-4843-4776-9da9-d526bd00f07a 55150-173 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan INJECTION, SOLUTION SUBCUTANEOUS 20130423 ANDA ANDA202758 AuroMedics Pharma LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 55150-173_9b1bb8c9-be3a-47c3-b3bc-9c983cde7d23 55150-173 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan INJECTION, SOLUTION SUBCUTANEOUS 20130423 ANDA ANDA202758 AuroMedics Pharma LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 55150-174_b37a0f73-df62-4bd8-8b59-86519e32833e 55150-174 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150619 ANDA ANDA203294 AuroMedics Pharma LLC AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55150-175_929d4530-5ea8-4774-98c6-62b58f97a2eb 55150-175 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20160706 ANDA ANDA204238 AuroMedics Pharma LLC GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55150-176_929d4530-5ea8-4774-98c6-62b58f97a2eb 55150-176 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20160706 ANDA ANDA204238 AuroMedics Pharma LLC GRANISETRON HYDROCHLORIDE 4 mg/4mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55150-177_fe971128-9139-41da-b6dd-3c15f50f94e2 55150-177 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION, SOLUTION INTRAVENOUS 20160201 ANDA ANDA204312 AuroMedics Pharma LLC LEVETIRACETAM 500 mg/5mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55150-178_4f21c5ec-3b5e-4311-88b2-ef96eb4a205b 55150-178 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120913 ANDA ANDA090340 AuroMedics Pharma LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55150-179_4f21c5ec-3b5e-4311-88b2-ef96eb4a205b 55150-179 HUMAN PRESCRIPTION DRUG Ampicillin and Sulbactam Ampicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120913 ANDA ANDA090340 AuroMedics Pharma LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 55150-180_6cd870d7-6381-421a-89bc-bce5c9518219 55150-180 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20171025 ANDA ANDA204550 AuroMedics Pharma LLC AMIODARONE HYDROCHLORIDE 150 mg/3mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 55150-181_6cd870d7-6381-421a-89bc-bce5c9518219 55150-181 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20171025 ANDA ANDA204550 AuroMedics Pharma LLC AMIODARONE HYDROCHLORIDE 450 mg/9mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 55150-182_6cd870d7-6381-421a-89bc-bce5c9518219 55150-182 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20171025 ANDA ANDA204550 AuroMedics Pharma LLC AMIODARONE HYDROCHLORIDE 900 mg/18mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 55150-184_00435406-67aa-4bbf-b9ec-132d5105129f 55150-184 HUMAN PRESCRIPTION DRUG Esomeprazole Sodium Esomeprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160810 ANDA ANDA204657 AuroMedics Pharma LLC ESOMEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55150-185_00435406-67aa-4bbf-b9ec-132d5105129f 55150-185 HUMAN PRESCRIPTION DRUG Esomeprazole Sodium Esomeprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160810 ANDA ANDA204657 AuroMedics Pharma LLC ESOMEPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55150-187_ba12637d-9daf-458a-8d65-0c4dfd897224 55150-187 HUMAN PRESCRIPTION DRUG Caffeine Citrate Caffeine Citrate INJECTION, SOLUTION INTRAVENOUS 20150922 ANDA ANDA205013 AuroMedics Pharma LLC CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 55150-188_aa4674b2-f1ff-4462-a85f-f48fa84b8a97 55150-188 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20160114 ANDA ANDA205035 AuroMedics Pharma LLC TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 55150-191_27dfd868-9642-432d-a31b-02121e4039ee 55150-191 HUMAN PRESCRIPTION DRUG Ibandronate Sodium Ibandronate Sodium INJECTION, SOLUTION INTRAVENOUS 20150819 ANDA ANDA205332 AuroMedics Pharma LLC IBANDRONATE SODIUM 3 mg/3mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 55150-192_6644663e-f233-4536-94af-d7dbab396abf 55150-192 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20171102 ANDA ANDA205331 AuroMedics Pharma LLC ADENOSINE 60 mg/20mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 55150-193_6644663e-f233-4536-94af-d7dbab396abf 55150-193 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION, SOLUTION INTRAVENOUS 20171102 ANDA ANDA205331 AuroMedics Pharma LLC ADENOSINE 90 mg/30mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 55150-194_ac22475d-2d78-469f-9435-b403ac4ee380 55150-194 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride Esmolol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20150723 ANDA ANDA205520 AuroMedics Pharma LLC ESMOLOL HYDROCHLORIDE 100 mg/10mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55150-195_22e703dc-d861-487d-9ca1-460a63bd122f 55150-195 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride Ropivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20160915 ANDA ANDA205612 AuroMedics Pharma LLC ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-196_22e703dc-d861-487d-9ca1-460a63bd122f 55150-196 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride Ropivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20160915 ANDA ANDA205612 AuroMedics Pharma LLC ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-197_22e703dc-d861-487d-9ca1-460a63bd122f 55150-197 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride Ropivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20160915 ANDA ANDA205612 AuroMedics Pharma LLC ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-198_22e703dc-d861-487d-9ca1-460a63bd122f 55150-198 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride Ropivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20160915 ANDA ANDA205612 AuroMedics Pharma LLC ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-199_22e703dc-d861-487d-9ca1-460a63bd122f 55150-199 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride Ropivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; PERINEURAL 20160915 ANDA ANDA205612 AuroMedics Pharma LLC ROPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-200_22e703dc-d861-487d-9ca1-460a63bd122f 55150-200 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride Ropivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL 20160915 ANDA ANDA205612 AuroMedics Pharma LLC ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-201_22e703dc-d861-487d-9ca1-460a63bd122f 55150-201 HUMAN PRESCRIPTION DRUG Ropivacaine Hydrochloride Ropivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL 20160915 ANDA ANDA205612 AuroMedics Pharma LLC ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-202_b4e3ae8c-7af7-464e-bb3e-11eb167909f1 55150-202 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160330 ANDA ANDA205675 AuroMedics Pharma LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 55150-203_24c26168-b5fb-4000-8a66-35c54665b8b8 55150-203 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160331 ANDA ANDA205780 AuroMedics Pharma LLC VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 55150-204_24c26168-b5fb-4000-8a66-35c54665b8b8 55150-204 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160331 ANDA ANDA205780 AuroMedics Pharma LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 55150-205_aa275e8e-bcd2-41e7-b70d-b17ac8a9dbb0 55150-205 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160329 ANDA ANDA205779 AuroMedics Pharma LLC VANCOMYCIN HYDROCHLORIDE 5 g/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 55150-206_aa275e8e-bcd2-41e7-b70d-b17ac8a9dbb0 55150-206 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160329 ANDA ANDA205779 AuroMedics Pharma LLC VANCOMYCIN HYDROCHLORIDE 10 g/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 55150-207_bf1d3433-9e3f-40a0-8bff-c8ceaa8bab7c 55150-207 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170327 ANDA ANDA205835 AuroMedics Pharma LLC MEROPENEM 500 mg/1 Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 55150-208_bf1d3433-9e3f-40a0-8bff-c8ceaa8bab7c 55150-208 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170327 ANDA ANDA205835 AuroMedics Pharma LLC MEROPENEM 1 g/1 Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 55150-209_db4d6cc6-d66b-41e1-8202-7505124c74c1 55150-209 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20160317 ANDA ANDA205867 AuroMedics Pharma LLC DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 55150-216_71d4bc78-57df-474b-8b19-811a959f1fce 55150-216 HUMAN PRESCRIPTION DRUG Atracurium Besylate Atracurium Besylate INJECTION, SOLUTION INTRAVENOUS 20150408 ANDA ANDA206010 AuroMedics Pharma LLC ATRACURIUM BESYLATE 50 mg/5mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 55150-217_f7b6a720-05a7-4d6a-9200-21bdc90fc1c4 55150-217 HUMAN PRESCRIPTION DRUG Atracurium Besylate Atracurium Besylate INJECTION, SOLUTION INTRAVENOUS 20150408 ANDA ANDA206011 AuroMedics Pharma LLC ATRACURIUM BESYLATE 100 mg/10mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 55150-218_73cc1b9a-42f7-4caf-9071-e44d33e9716c 55150-218 HUMAN PRESCRIPTION DRUG Eptifibatide Eptifibatide INJECTION INTRAVENOUS 20151208 ANDA ANDA206127 AuroMedics Pharma LLC EPTIFIBATIDE 75 mg/100mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 55150-219_73cc1b9a-42f7-4caf-9071-e44d33e9716c 55150-219 HUMAN PRESCRIPTION DRUG Eptifibatide Eptifibatide INJECTION INTRAVENOUS 20151208 ANDA ANDA206127 AuroMedics Pharma LLC EPTIFIBATIDE 20 mg/10mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 55150-220_73cc1b9a-42f7-4caf-9071-e44d33e9716c 55150-220 HUMAN PRESCRIPTION DRUG Eptifibatide Eptifibatide INJECTION INTRAVENOUS 20151208 ANDA ANDA206127 AuroMedics Pharma LLC EPTIFIBATIDE 200 mg/100mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 55150-221_4d7dd4a0-4504-462a-95b1-65ad31224aa9 55150-221 HUMAN PRESCRIPTION DRUG ETOMIDATE ETOMIDATE INJECTION, SOLUTION INTRAVENOUS 20170224 ANDA ANDA206126 AuroMedics Pharma LLC ETOMIDATE 20 mg/10mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 55150-222_4d7dd4a0-4504-462a-95b1-65ad31224aa9 55150-222 HUMAN PRESCRIPTION DRUG ETOMIDATE ETOMIDATE INJECTION, SOLUTION INTRAVENOUS 20170224 ANDA ANDA206126 AuroMedics Pharma LLC ETOMIDATE 40 mg/20mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 55150-223_bebfcf7d-92aa-4539-a0e0-5d848fb30379 55150-223 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160527 ANDA ANDA206128 AuroMedics Pharma LLC METHOCARBAMOL 1000 mg/10mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55150-225_116385ea-69fc-4f44-b463-6210291032df 55150-225 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20170412 ANDA ANDA206206 AuroMedics Pharma LLC ROCURONIUM BROMIDE 50 mg/5mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 55150-226_116385ea-69fc-4f44-b463-6210291032df 55150-226 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20170412 ANDA ANDA206206 AuroMedics Pharma LLC ROCURONIUM BROMIDE 100 mg/10mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 55150-230_8ea61d0d-4403-4d9f-a946-85a459cc0aa0 55150-230 HUMAN PRESCRIPTION DRUG FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTION, SOLUTION SUBCUTANEOUS 20171226 ANDA ANDA206918 AuroMedics Pharma LLC FONDAPARINUX SODIUM 2.5 mg/.5mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20191231 55150-231_8ea61d0d-4403-4d9f-a946-85a459cc0aa0 55150-231 HUMAN PRESCRIPTION DRUG FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTION, SOLUTION SUBCUTANEOUS 20171226 ANDA ANDA206918 AuroMedics Pharma LLC FONDAPARINUX SODIUM 5 mg/.4mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20191231 55150-232_8ea61d0d-4403-4d9f-a946-85a459cc0aa0 55150-232 HUMAN PRESCRIPTION DRUG FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTION, SOLUTION SUBCUTANEOUS 20171226 ANDA ANDA206918 AuroMedics Pharma LLC FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20191231 55150-233_8ea61d0d-4403-4d9f-a946-85a459cc0aa0 55150-233 HUMAN PRESCRIPTION DRUG FONDAPARINUX SODIUM FONDAPARINUX SODIUM INJECTION, SOLUTION SUBCUTANEOUS 20171226 ANDA ANDA206918 AuroMedics Pharma LLC FONDAPARINUX SODIUM 10 mg/.8mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20191231 55150-234_04505c5f-d24d-4fba-9f17-8d14229a8b48 55150-234 HUMAN PRESCRIPTION DRUG Polymyxin B Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20160404 ANDA ANDA206589 AuroMedics Pharma LLC POLYMYXIN B SULFATE 500000 [USP'U]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 55150-237_4dae51f7-b0d1-4a7d-afd8-9f5c628c3711 55150-237 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20151201 ANDA ANDA206781 AuroMedics Pharma LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55150-238_4dae51f7-b0d1-4a7d-afd8-9f5c628c3711 55150-238 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20151201 ANDA ANDA206781 AuroMedics Pharma LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55150-239_4dae51f7-b0d1-4a7d-afd8-9f5c628c3711 55150-239 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20151201 ANDA ANDA206781 AuroMedics Pharma LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55150-240_42f2d62a-c7f2-4706-87bc-64f3e72d63a9 55150-240 HUMAN PRESCRIPTION DRUG Isosulfan Blue Isosulfan Blue INJECTION, SOLUTION SUBCUTANEOUS 20160202 ANDA ANDA206831 AuroMedics Pharma LLC ISOSULFAN BLUE 50 mg/5mL N 20181231 55150-240_61b48ff8-7ace-4ab7-9f58-f250e2830d16 55150-240 HUMAN PRESCRIPTION DRUG Isosulfan Blue Isosulfan Blue INJECTION, SOLUTION SUBCUTANEOUS 20160202 ANDA ANDA206831 AuroMedics Pharma LLC ISOSULFAN BLUE 50 mg/5mL N 20181231 55150-242_4fc9df95-8aad-46f6-bab9-eaafc7c89679 55150-242 HUMAN PRESCRIPTION DRUG Linezolid Linezolid INJECTION, SOLUTION INTRAVENOUS 20160804 ANDA ANDA206917 AuroMedics Pharma LLC LINEZOLID 600 mg/300mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 55150-243_e86dc766-ce6b-46c5-83a1-4909608468d1 55150-243 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20160210 ANDA ANDA206919 AuroMedics Pharma LLC LEVOFLOXACIN 250 mg/50mL N 20181231 55150-244_e86dc766-ce6b-46c5-83a1-4909608468d1 55150-244 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20160210 ANDA ANDA206919 AuroMedics Pharma LLC LEVOFLOXACIN 500 mg/100mL N 20181231 55150-245_e86dc766-ce6b-46c5-83a1-4909608468d1 55150-245 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin INJECTION, SOLUTION INTRAVENOUS 20160210 ANDA ANDA206919 AuroMedics Pharma LLC LEVOFLOXACIN 750 mg/150mL N 20181231 55150-246_1fbdc074-73ff-4c9b-8844-30d0c86e6216 55150-246 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION, SOLUTION INTRAVENOUS 20170104 ANDA ANDA207160 AuroMedics Pharma LLC LEVETIRACETAM 500 mg/100mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55150-247_1fbdc074-73ff-4c9b-8844-30d0c86e6216 55150-247 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION, SOLUTION INTRAVENOUS 20170104 ANDA ANDA207160 AuroMedics Pharma LLC LEVETIRACETAM 1000 mg/100mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55150-248_1fbdc074-73ff-4c9b-8844-30d0c86e6216 55150-248 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION, SOLUTION INTRAVENOUS 20170104 ANDA ANDA207160 AuroMedics Pharma LLC LEVETIRACETAM 1500 mg/100mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55150-249_d6f47555-0e2a-48b8-a488-c9aa91736c17 55150-249 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20160513 ANDA ANDA207183 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-250_d6f47555-0e2a-48b8-a488-c9aa91736c17 55150-250 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION PERINEURAL 20160513 ANDA ANDA207183 AuroMedics Pharma LLC BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55150-251_ef782e5e-e2d7-465a-99c6-b12611f3158c 55150-251 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20171030 ANDA ANDA207182 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-252_ef782e5e-e2d7-465a-99c6-b12611f3158c 55150-252 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20171030 ANDA ANDA207182 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-253_ef782e5e-e2d7-465a-99c6-b12611f3158c 55150-253 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20171030 ANDA ANDA207182 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-254_ef782e5e-e2d7-465a-99c6-b12611f3158c 55150-254 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20171030 ANDA ANDA207182 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-255_ef782e5e-e2d7-465a-99c6-b12611f3158c 55150-255 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20171030 ANDA ANDA207182 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-256_ef782e5e-e2d7-465a-99c6-b12611f3158c 55150-256 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20171030 ANDA ANDA207182 AuroMedics Pharma LLC LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55150-259_5ae53725-1abb-4122-9c85-f26c2c31566c 55150-259 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine INJECTION, SOLUTION INTRAVENOUS 20160229 ANDA ANDA207358 AuroMedics Pharma LLC ACETYLCYSTEINE 6 g/30mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 55150-262_875c7844-2607-4edb-ae16-345f348a9536 55150-262 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate Methylprednisolone Sodium Succinate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151215 ANDA ANDA207667 AuroMedics Pharma LLC METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55150-263_875c7844-2607-4edb-ae16-345f348a9536 55150-263 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate Methylprednisolone Sodium Succinate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151215 ANDA ANDA207667 AuroMedics Pharma LLC METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55150-264_875c7844-2607-4edb-ae16-345f348a9536 55150-264 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate Methylprednisolone Sodium Succinate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151215 ANDA ANDA207667 AuroMedics Pharma LLC METHYLPREDNISOLONE SODIUM SUCCINATE 500 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55150-265_875c7844-2607-4edb-ae16-345f348a9536 55150-265 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate Methylprednisolone Sodium Succinate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151215 ANDA ANDA207667 AuroMedics Pharma LLC METHYLPREDNISOLONE SODIUM SUCCINATE 2 g/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55150-266_9921c2fa-5b3f-4e06-8dd6-1c1352d6b255 55150-266 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160926 ANDA ANDA207751 AuroMedics Pharma LLC ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 55150-267_1f532edc-1a2c-4221-80dd-1ac158dd3a72 55150-267 HUMAN PRESCRIPTION DRUG FLUPHENAZINE DECANOATE FLUPHENAZINE DECANOATE INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20171017 ANDA ANDA207739 AuroMedics Pharma LLC FLUPHENAZINE DECANOATE 125 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 55150-283_bf5f96d4-f87c-4968-bed0-a4b5e77f4162 55150-283 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20171208 ANDA ANDA209125 AuroMedics Pharma LLC ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 55151-123_21963db4-acde-492b-8242-75b5394a198f 55151-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20110101 UNAPPROVED MEDICAL GAS E-Z Oxygen LLC, dba AO2 OXYGEN 99 L/100L N 20181231 55154-0082_00f1a642-3350-43fb-9efb-2d7bb2555ace 55154-0082 HUMAN PRESCRIPTION DRUG TRUVADA emtricitabine and tenofovir disoproxil fumarate TABLET ORAL 20040802 NDA NDA021752 Cardinal Health TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE 300; 200 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 55154-0103_494efa27-57a2-4bea-b7b6-17b421d85d3a 55154-0103 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20050228 NDA NDA018803 Cardinal Health SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55154-0109_cb72ed2c-f674-4b63-98c3-1e43b52ce11f 55154-0109 HUMAN PRESCRIPTION DRUG Biaxin Clarithromycin TABLET, FILM COATED ORAL 19911031 NDA NDA050662 Cardinal Health CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 55154-0119_a9a95fc3-d6da-4657-916f-5c7534309e62 55154-0119 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19850418 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE 84 mg/mL N 20181231 55154-0120_3ba7e84c-6192-4925-9f71-a0dbc6105253 55154-0120 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110727 ANDA ANDA074802 Cardinal Health KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 55154-0124_dbdf706d-8fda-4fac-93cd-0c4bfb7220b7 55154-0124 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088299 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-0126_6a5f7507-9dbb-4928-80be-b110ba1acfc8 55154-0126 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110908 NDA NDA018803 Cardinal Health SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55154-0127_a74de26f-7b83-4913-b541-9aa3560c4a99 55154-0127 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110915 NDA NDA018801 Cardinal Health WATER 1 mL/mL E 20171231 55154-0132_164589b1-cd3d-4fde-880b-1318fe62f789 55154-0132 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089644 Cardinal Health LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 10; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55154-0147_4e501728-2c92-4b0a-9ec9-4300094e5086 55154-0147 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100330 ANDA ANDA088329 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-0149_3ba7e84c-6192-4925-9f71-a0dbc6105253 55154-0149 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20110727 ANDA ANDA074802 Cardinal Health KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 55154-0154_7cdef849-0c70-4843-8f6d-ed7377a25ebd 55154-0154 HUMAN OTC DRUG White petrolatum White petrolatum OINTMENT TOPICAL 20110620 OTC MONOGRAPH FINAL part347 Cardinal Health PETROLATUM 5 g/1 E 20171231 55154-0156_789f84d1-1bc9-4750-8419-6a4bd36e996b 55154-0156 HUMAN OTC DRUG Triple Antibiotic Neomycin, Polymyxin B Sulfates, Bacitracin OINTMENT TOPICAL 20110606 OTC MONOGRAPH FINAL part333B Cardinal Health NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 5000; 400 mg/1; [USP'U]/1; [USP'U]/1 E 20171231 55154-0218_9aae719d-9e66-48d8-ac46-2c9f23e1726c 55154-0218 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Cardinal Health ESTROGENS, CONJUGATED .45 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 55154-0219_9aae719d-9e66-48d8-ac46-2c9f23e1726c 55154-0219 HUMAN PRESCRIPTION DRUG Premarin conjugated estrogens TABLET, FILM COATED ORAL 20060101 NDA NDA004782 Cardinal Health ESTROGENS, CONJUGATED .9 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] N 20181231 55154-0253_646867ac-0377-422c-b5ba-c0d89b947e9c 55154-0253 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20020830 NDA NDA021428 Cardinal Health LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 55154-0328_1c392554-bc9b-4931-84b8-15d2718e666b 55154-0328 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Cardinal Health ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 55154-0410_2588aba0-a4ff-4ac4-ba6b-0f3a2174858e 55154-0410 HUMAN PRESCRIPTION DRUG Tradjenta linagliptin TABLET, FILM COATED ORAL 20110509 NDA NDA201280 Cardinal Health LINAGLIPTIN 5 mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] N 20181231 55154-0411_5777b8a8-ada6-4950-8548-43a1de11f075 55154-0411 HUMAN PRESCRIPTION DRUG Jardiance Empagliflozin TABLET, FILM COATED ORAL 20140801 NDA NDA204629 Cardinal Health EMPAGLIFLOZIN 10 mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] N 20181231 55154-0412_5777b8a8-ada6-4950-8548-43a1de11f075 55154-0412 HUMAN PRESCRIPTION DRUG Jardiance Empagliflozin TABLET, FILM COATED ORAL 20140801 NDA NDA204629 Cardinal Health EMPAGLIFLOZIN 25 mg/1 Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA] N 20181231 55154-0450_b625e0bc-83cc-4fca-9442-8830ecaca893 55154-0450 HUMAN PRESCRIPTION DRUG Metoclopramide hydrochloride Metoclopramide hydrochloride INJECTION INTRAVENOUS 19931210 ANDA ANDA073135 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 55154-0475_561f948c-3a71-49a8-91ff-d9e140f37e0a 55154-0475 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150429 ANDA ANDA070044 Cardinal Health METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 55154-0525_dddb19d3-8a1d-4616-a503-0f224f94e49b 55154-0525 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 19960718 NDA AUTHORIZED GENERIC NDA050711 Cardinal Health AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 55154-0527_33c380cd-c09d-46a7-8b25-4e9b401be379 55154-0527 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Cardinal Health SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 55154-0532_33c380cd-c09d-46a7-8b25-4e9b401be379 55154-0532 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Cardinal Health SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 55154-0535_6ab295f7-c7f2-4c27-ba33-14af5e4c5a44 55154-0535 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 19920731 NDA NDA019787 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 55154-0539_d926cfc7-3bc5-489d-95ae-814c6eee1171 55154-0539 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 19940426 NDA NDA020329 Cardinal Health GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 55154-0553_e613de7a-019b-4680-bc22-06633af488b5 55154-0553 HUMAN PRESCRIPTION DRUG ELMIRON PENTOSAN POLYSULFATE SODIUM CAPSULE, GELATIN COATED ORAL 19960926 NDA NDA020193 Cardinal Health PENTOSAN POLYSULFATE SODIUM 100 mg/1 Glycosaminoglycan [EPC],Glycosaminoglycans [Chemical/Ingredient] N 20181231 55154-0612_2302897f-2334-4e9f-9596-12c40e1819de 55154-0612 HUMAN PRESCRIPTION DRUG ELIQUIS apixaban TABLET, FILM COATED ORAL 20121228 NDA NDA202155 Cardinal Health APIXABAN 2.5 mg/1 Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 55154-0613_2302897f-2334-4e9f-9596-12c40e1819de 55154-0613 HUMAN PRESCRIPTION DRUG ELIQUIS apixaban TABLET, FILM COATED ORAL 20121228 NDA NDA202155 Cardinal Health APIXABAN 5 mg/1 Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 55154-0657_c406d1ed-68f8-4227-b44b-e61b18283ccb 55154-0657 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20040203 ANDA ANDA071655 Cardinal Health OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 55154-0659_9fb67d9c-3dbb-4651-b64d-8af63923dbea 55154-0659 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20040203 ANDA ANDA071524 Cardinal Health TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 55154-0661_8f4873a0-372d-43ea-aae7-c67cfb5fafb9 55154-0661 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl CAPSULE ORAL 20090102 OTC MONOGRAPH NOT FINAL part348 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 E 20171231 55154-0663_104dab88-820a-4f2c-9810-5909aa8f19d4 55154-0663 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19980808 ANDA ANDA070027 Cardinal Health METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 55154-0667_8017d3cf-76eb-419f-9117-ecb6d30b72f0 55154-0667 HUMAN OTC DRUG DOK Docusate Sodium CAPSULE ORAL 20110606 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM 100 mg/1 E 20171231 55154-0669_6b4ed3c7-921d-4aad-bffc-efb9dc91e6b9 55154-0669 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20110603 ANDA ANDA075139 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 55154-0676_db2eaefe-2af9-4dbd-9927-5284976b4c71 55154-0676 HUMAN PRESCRIPTION DRUG K-Vescent Efffervescent Potassium Bicarbonate TABLET, EFFERVESCENT ORAL 20050422 20180430 UNAPPROVED DRUG OTHER Cardinal Health POTASSIUM BICARBONATE 25 meq/1 N 20181231 55154-0677_946133ff-67c8-4d3f-8dd4-6d1e72f87f1d 55154-0677 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20100715 ANDA ANDA072234 Cardinal Health BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 55154-0681_f928842a-a3f7-4fe9-a86c-e7a2adcb9d25 55154-0681 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 20110603 OTC MONOGRAPH NOT FINAL part334 Cardinal Health SENNOSIDES 8.6 mg/1 E 20171231 55154-0683_f59ddb0e-f32b-4802-b187-305f5d8d5af0 55154-0683 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl CAPSULE ORAL 20110603 OTC MONOGRAPH FINAL part336 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 55154-0685_919c4f57-8d44-4402-9a62-adb7417f4844 55154-0685 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20061120 ANDA ANDA070974 Cardinal Health CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55154-0696_c25caca1-ccb9-4100-b01b-cc432a29375a 55154-0696 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20020813 ANDA ANDA072265 Cardinal Health BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 55154-0733_d0acbb23-8a2d-4fc9-aa45-9e3b8f848eff 55154-0733 HUMAN OTC DRUG DOK Plus DOK Plus TABLET, FILM COATED ORAL 20110607 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 55154-0741_3073520f-46d1-4d9f-8459-5827c7d8df94 55154-0741 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Cardinal Health IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55154-0746_bb779d66-678d-41cf-aa17-7014973b5d52 55154-0746 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110531 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 500 mg/1 N 20181231 55154-0748_5a3410c9-13fe-4a60-ac69-bb16f1c6d8d4 55154-0748 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 20110523 20180731 UNAPPROVED DRUG OTHER Cardinal Health ASPIRIN 81 mg/1 N 20181231 55154-0777_18b00209-210b-4159-a36f-5739812fc5cd 55154-0777 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20150501 ANDA ANDA202038 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55154-0844_381eb117-d525-4cb4-af05-9ef7d750dc18 55154-0844 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20060510 ANDA ANDA077754 Cardinal Health LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-0845_381eb117-d525-4cb4-af05-9ef7d750dc18 55154-0845 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 ANDA ANDA077754 Cardinal Health LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-0926_12178380-327f-48de-84c2-71b8009fcdf7 55154-0926 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20140901 ANDA ANDA074726 Cardinal Health POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 55154-0927_7c3f1e86-7393-4a38-b85f-8ed39831c04b 55154-0927 HUMAN PRESCRIPTION DRUG KLOR-CON potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140901 NDA NDA019123 Cardinal Health POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 55154-0928_12178380-327f-48de-84c2-71b8009fcdf7 55154-0928 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20140901 ANDA ANDA074726 Cardinal Health POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 55154-0975_46f787bf-742b-441b-bbb0-e5bc0d5efea4 55154-0975 HUMAN PRESCRIPTION DRUG PROVIGIL modafinil TABLET ORAL 19981224 NDA NDA020717 Cardinal Health MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV E 20171231 55154-1032_8c54b68f-cc5b-4e97-9253-b9c2c439da59 55154-1032 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120120 ANDA ANDA078457 Cardinal Health QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 55154-1134_c41a930c-8678-4460-8e95-4e84309fe069 55154-1134 HUMAN PRESCRIPTION DRUG LOVAZA omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20081021 NDA NDA021654 Cardinal Health OMEGA-3-ACID ETHYL ESTERS 1 g/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] E 20171231 55154-1186_a3a9858c-be31-41c0-ad55-551f05da4f0f 55154-1186 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Cardinal Health NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 55154-1276_8a021852-9fec-493d-b787-6034da74e601 55154-1276 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 Cardinal Health ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 55154-1279_fe4d692d-27b0-48f4-a2e9-5d058efd57bf 55154-1279 HUMAN PRESCRIPTION DRUG Adenosine adenosine INJECTION, SOLUTION INTRAVENOUS 20110317 ANDA ANDA078076 Cardinal Health ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20191231 55154-1280_76839e58-ded9-440c-a016-e10aae455ac2 55154-1280 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20090501 ANDA ANDA040730 Cardinal Health HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 55154-1281_1a3e5d1d-4fd4-461c-93c7-9c51d1da96fc 55154-1281 HUMAN PRESCRIPTION DRUG Physostigmine Salicylate Physostigmine Salicylate INJECTION INTRAVENOUS 20100810 20181130 UNAPPROVED DRUG OTHER Cardinal Health PHYSOSTIGMINE SALICYLATE 1 mg/mL N 20181231 55154-1325_d7c2c2aa-8c73-45da-9984-581e4bdea76b 55154-1325 HUMAN OTC DRUG Mapap Acetaminophen TABLET ORAL 20110421 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 325 mg/1 N 20181231 55154-1337_8ec58698-6b12-4c33-8285-737bf11798de 55154-1337 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20081030 ANDA ANDA040733 Cardinal Health DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 55154-1339_cee82e3f-0814-4cc6-a184-3a5949eb0373 55154-1339 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20040203 ANDA ANDA075483 Cardinal Health ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 55154-1340_cee82e3f-0814-4cc6-a184-3a5949eb0373 55154-1340 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20040203 ANDA ANDA075483 Cardinal Health ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 55154-1341_d1dff7bb-6b46-45d8-8871-3eff38998d48 55154-1341 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20070216 ANDA ANDA076001 Cardinal Health FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-1342_3073520f-46d1-4d9f-8459-5827c7d8df94 55154-1342 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Cardinal Health IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55154-1347_c25caca1-ccb9-4100-b01b-cc432a29375a 55154-1347 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20020813 ANDA ANDA072264 Cardinal Health BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 55154-1375_536fce9d-c40a-4363-879d-fbdc40076367 55154-1375 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20091102 ANDA ANDA074823 Cardinal Health TERAZOSIN HYDROCHLORIDE ANHYDROUS 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 55154-1379_769c16d8-1998-4805-8f6b-ff191e661cc5 55154-1379 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Cardinal Health GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55154-1380_3073520f-46d1-4d9f-8459-5827c7d8df94 55154-1380 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090610 ANDA ANDA075682 Cardinal Health IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55154-1385_536fce9d-c40a-4363-879d-fbdc40076367 55154-1385 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20091102 ANDA ANDA074823 Cardinal Health TERAZOSIN HYDROCHLORIDE ANHYDROUS 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 55154-1386_63d34a9f-c03b-4e3c-821c-8414f4fd1daf 55154-1386 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100510 ANDA ANDA078428 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-1387_63d34a9f-c03b-4e3c-821c-8414f4fd1daf 55154-1387 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100510 ANDA ANDA078428 Cardinal Health GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-1389_2834ce85-fbe6-4e37-b925-d7f8713bcd4c 55154-1389 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20100604 ANDA ANDA078251 Cardinal Health CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 55154-1390_2cd4dbd4-33be-49be-ab2a-03f71c115d49 55154-1390 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100607 ANDA ANDA077584 Cardinal Health PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-1391_2cd4dbd4-33be-49be-ab2a-03f71c115d49 55154-1391 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100607 ANDA ANDA077584 Cardinal Health PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-1394_63d34a9f-c03b-4e3c-821c-8414f4fd1daf 55154-1394 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100510 ANDA ANDA078428 Cardinal Health GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-1396_35e9be3a-413b-4bfb-aaf6-5789770ed97a 55154-1396 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20100920 ANDA ANDA077272 Cardinal Health CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 55154-1397_857be233-613e-4a2a-aab5-c53c55eec8e6 55154-1397 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20100723 ANDA ANDA077824 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 55154-1411_9242cdf5-a9d3-4722-ad40-8fdd00120024 55154-1411 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Cardinal Health RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 55154-1412_9242cdf5-a9d3-4722-ad40-8fdd00120024 55154-1412 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Cardinal Health RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 55154-1413_9242cdf5-a9d3-4722-ad40-8fdd00120024 55154-1413 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Cardinal Health RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 55154-1414_9242cdf5-a9d3-4722-ad40-8fdd00120024 55154-1414 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET ORAL 19931229 NDA NDA020272 Cardinal Health RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 55154-1422_cb8f73ea-f8b1-4c94-a7f0-bf7bbd655b64 55154-1422 HUMAN PRESCRIPTION DRUG Xarelto rivaroxaban TABLET, FILM COATED ORAL 20110701 NDA NDA022406 Cardinal Health RIVAROXABAN 10 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] N 20181231 55154-1423_cb8f73ea-f8b1-4c94-a7f0-bf7bbd655b64 55154-1423 HUMAN PRESCRIPTION DRUG Xarelto rivaroxaban TABLET, FILM COATED ORAL 20111105 NDA NDA202439 Cardinal Health RIVAROXABAN 20 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] N 20181231 55154-1424_cb8f73ea-f8b1-4c94-a7f0-bf7bbd655b64 55154-1424 HUMAN PRESCRIPTION DRUG Xarelto rivaroxaban TABLET, FILM COATED ORAL 20111104 NDA NDA202439 Cardinal Health RIVAROXABAN 15 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] N 20181231 55154-1458_fe6491ab-534c-4a62-8804-b1f3feb2e995 55154-1458 HUMAN OTC DRUG Oyster Shell Calcium with Vitamin D Oyster Shell Calcium with Vitamin D TABLET, FILM COATED ORAL 20051115 UNAPPROVED DRUG OTHER Cardinal Health CALCIUM; CHOLECALCIFEROL 500; 200 mg/1; [iU]/1 N 20181231 55154-1473_49a95e9b-0343-44e5-9812-5cea98eae001 55154-1473 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 20141218 OTC MONOGRAPH FINAL part343 Cardinal Health ASPIRIN 81 mg/1 N 20181231 55154-1478_512e593a-3f26-4955-b1db-a0ed09d3b5cb 55154-1478 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20090810 ANDA ANDA074726 Cardinal Health POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 55154-1479_27ffb185-0ea7-4a9d-9e91-d525b27d018c 55154-1479 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20090720 ANDA ANDA075682 Cardinal Health IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 55154-1480_bd5b2ffe-bb69-40c4-95a5-1c0efaa47771 55154-1480 HUMAN OTC DRUG Simethicone Simethicone TABLET ORAL 20110606 UNAPPROVED DRUG OTHER Cardinal Health DIMETHICONE 80 mg/1 N 20191231 55154-1482_6fe81008-093a-47d4-8106-69db483d0cfc 55154-1482 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100901 ANDA ANDA072927 Cardinal Health LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-1483_5af21be1-a217-4288-9f12-921d1dcf8465 55154-1483 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070628 ANDA ANDA040412 Cardinal Health HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55154-1484_990085b0-23ed-41b8-a87c-87c525f10733 55154-1484 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20050110 20180430 ANDA ANDA073589 Cardinal Health CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 55154-1485_1c9b1dc0-fb7f-43d9-8a8f-6e5989bbfc36 55154-1485 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20101108 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM 100 mg/1 E 20171231 55154-1487_7c16b5fe-4d6e-45b5-a063-df01076be7a2 55154-1487 HUMAN PRESCRIPTION DRUG Hydralazine Hydralazine TABLET ORAL 20090914 ANDA ANDA088468 Cardinal Health HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 55154-1489_c42e2e69-06c1-43ba-9358-2a0215e200f2 55154-1489 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20070709 ANDA ANDA040489 Cardinal Health METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 55154-1490_7c16b5fe-4d6e-45b5-a063-df01076be7a2 55154-1490 HUMAN PRESCRIPTION DRUG Hydralazine Hydralazine TABLET ORAL 20090914 ANDA ANDA088468 Cardinal Health HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 55154-1492_da376890-9e76-445b-8519-bee180adbbc6 55154-1492 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20061115 ANDA ANDA071135 Cardinal Health DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 55154-1493_a045d5da-9980-4a35-84e5-c8bc5a7a3e0b 55154-1493 HUMAN OTC DRUG aspirin aspirin TABLET, COATED ORAL 20121113 OTC MONOGRAPH FINAL part343 Cardinal Health ASPIRIN 81 mg/1 E 20171231 55154-1494_34db7890-987f-4934-9295-dd2606676f45 55154-1494 HUMAN OTC DRUG aspirin aspirin TABLET, COATED ORAL 20121113 OTC MONOGRAPH FINAL part343 Cardinal Health ASPIRIN 81 mg/1 N 20181231 55154-1495_d43c28bd-241e-48a8-8612-99988ea50afb 55154-1495 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20110601 ANDA ANDA091426 Cardinal Health SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20191231 55154-1497_c1513777-d357-4b8f-8f11-78093060330b 55154-1497 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20111101 ANDA ANDA040655 Cardinal Health HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 55154-1498_3fc428dc-47a0-4997-8b32-e68bfd4f6ca1 55154-1498 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110822 ANDA ANDA078010 Cardinal Health FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 55154-1499_c42e2e69-06c1-43ba-9358-2a0215e200f2 55154-1499 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20070703 ANDA ANDA040489 Cardinal Health METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 55154-1575_422805a2-6aae-47b1-bdda-4b8b8684a333 55154-1575 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 20031210 ANDA ANDA070868 Cardinal Health VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55154-1577_927b555b-73f1-49a7-a72e-e9d2596692d8 55154-1577 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20040413 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL N 20191231 55154-1578_337f101e-b356-4275-a33c-721716a0b591 55154-1578 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20051215 ANDA ANDA062512 Cardinal Health NYSTATIN 500000 [USP'U]/5mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 55154-1579_4545d630-a545-4e2f-99ff-6169400230dc 55154-1579 HUMAN PRESCRIPTION DRUG Megestrol Acetate megestrol acetate SUSPENSION ORAL 20040225 ANDA ANDA075671 Cardinal Health MEGESTROL ACETATE 400 mg/10mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 55154-1582_4545d630-a545-4e2f-99ff-6169400230dc 55154-1582 HUMAN PRESCRIPTION DRUG Megestrol Acetate megestrol acetate SUSPENSION ORAL 20040225 ANDA ANDA075671 Cardinal Health MEGESTROL ACETATE 400 mg/10mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 55154-1585_1c7a2963-a3a9-47ac-bac2-adc4f0587f86 55154-1585 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060914 ANDA ANDA074937 Cardinal Health IBUPROFEN 200 mg/10mL N 20191231 55154-1586_d4d7cbef-66b0-4499-96f4-9d0d7e7e81ec 55154-1586 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20140411 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL N 20191231 55154-1587_f27ed1b7-09fb-4ebd-93c4-04d5def13d4c 55154-1587 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20140623 ANDA ANDA075671 Cardinal Health MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 55154-1610_7953667c-898a-415e-958e-c56f697c2125 55154-1610 HUMAN PRESCRIPTION DRUG Dilaudid hydromorphone hydrochloride TABLET ORAL 19260101 NDA NDA019892 Cardinal Health HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 55154-1830_0a445d27-f35f-4968-b86b-19abdd09d8c3 55154-1830 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Cardinal Health TADALAFIL 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 55154-1831_b1c22e2c-3b3d-46c5-a342-30a5f6cfb84d 55154-1831 HUMAN PRESCRIPTION DRUG Effient Prasugrel hydrochloride TABLET, FILM COATED ORAL 20120301 NDA NDA022307 Cardinal Health PRASUGREL HYDROCHLORIDE 10 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] E 20171231 55154-1832_0a445d27-f35f-4968-b86b-19abdd09d8c3 55154-1832 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Cardinal Health TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 55154-1855_a8b08d72-9446-42c7-8b7b-d46561d3b4ae 55154-1855 HUMAN PRESCRIPTION DRUG URSO ursodiol TABLET, FILM COATED ORAL 19971210 NDA NDA020675 Cardinal Health URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] E 20171231 55154-1875_8eea56da-05db-4bfa-9ac6-861a6263e4cd 55154-1875 HUMAN OTC DRUG Docusate Calcium docusate calcium CAPSULE, LIQUID FILLED ORAL 20110601 20180228 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE CALCIUM 240 mg/1 N 20181231 55154-1918_66f6d7a4-a3b1-4e42-adff-8425f701d830 55154-1918 HUMAN OTC DRUG Tylenol Acetaminophen TABLET ORAL 20110606 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 325 mg/1 E 20171231 55154-1928_99d3304a-e7d0-4be9-a1f2-4dde58c08de8 55154-1928 HUMAN OTC DRUG Tylenol Acetaminophen TABLET, FILM COATED ORAL 20110606 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 325 mg/1 N 20191231 55154-1929_90531187-0e8a-4910-aca3-bd02e8931b46 55154-1929 HUMAN OTC DRUG TYLENOL Extra Strength Acetaminophen TABLET, COATED ORAL 19940819 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 500 mg/1 E 20171231 55154-1950_cf01a0ae-3ace-44db-9c0e-5731535b82a1 55154-1950 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20110620 OTC MONOGRAPH FINAL part333B Cardinal Health BACITRACIN 500 [USP'U]/g N 20191231 55154-1953_0416d83c-ec33-436d-9c30-f5062cfb4320 55154-1953 HUMAN OTC DRUG Triple Antibiotic Polymyxin B, Bacitracin, Neomycin OINTMENT TOPICAL 20110606 OTC MONOGRAPH FINAL part333B Cardinal Health BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g E 20171231 55154-1955_c6a3d7d5-95f5-42d3-af67-a5458b8d72b9 55154-1955 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140520 OTC MONOGRAPH FINAL part333B Cardinal Health BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20191231 55154-2051_fb3d8b1e-45d2-4ae4-ab22-6c31f9014d1d 55154-2051 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100115 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 55154-2052_fb3d8b1e-45d2-4ae4-ab22-6c31f9014d1d 55154-2052 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100115 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 55154-2056_b9c6e647-d23c-4026-abc2-49a555b4f3d6 55154-2056 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090311 NDA NDA018832 Cardinal Health ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20191231 55154-2064_c94ad8ea-02e2-47ea-a307-a3de447123b5 55154-2064 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091221 ANDA ANDA040625 Cardinal Health FOLIC ACID 1 mg/1 N 20181231 55154-2065_966985fe-de32-4db1-85eb-7b74193b667d 55154-2065 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090922 ANDA ANDA077633 Cardinal Health LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 55154-2068_7dbc4275-2472-4eba-a8b1-6e4fe5cab5bf 55154-2068 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041210 ANDA ANDA075350 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-2069_ef094cc5-d9cd-4d6c-ac22-f8ee6ae28528 55154-2069 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20091014 ANDA ANDA078426 Cardinal Health ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 55154-2070_ef094cc5-d9cd-4d6c-ac22-f8ee6ae28528 55154-2070 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20091014 ANDA ANDA078426 Cardinal Health ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 55154-2073_895240b9-d587-4237-a921-1fe0dab83d75 55154-2073 HUMAN PRESCRIPTION DRUG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET ORAL 20090924 ANDA ANDA040511 Cardinal Health BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 55154-2074_7832fd06-bf4e-461f-aaf4-06f89164e13e 55154-2074 HUMAN PRESCRIPTION DRUG Hydroxychloroquine sulfate Hydroxychloroquine sulfate TABLET, FILM COATED ORAL 20080805 ANDA ANDA040657 Cardinal Health HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20191231 55154-2078_7dbc4275-2472-4eba-a8b1-6e4fe5cab5bf 55154-2078 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041210 ANDA ANDA075350 Cardinal Health GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-2081_8b8f8a99-1d73-444f-9378-23afc3532abd 55154-2081 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040819 ANDA ANDA076794 Cardinal Health CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 55154-2082_7aa3520f-c7ad-46f3-ac65-ffcdaba79113 55154-2082 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20080318 ANDA ANDA086242 Cardinal Health HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 55154-2083_7aa3520f-c7ad-46f3-ac65-ffcdaba79113 55154-2083 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20080318 ANDA ANDA086242 Cardinal Health HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 55154-2084_a55aea68-42d5-44fc-8916-22b978af5a59 55154-2084 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110207 ANDA ANDA077058 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 55154-2086_8b8f8a99-1d73-444f-9378-23afc3532abd 55154-2086 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040819 ANDA ANDA076794 Cardinal Health CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 55154-2087_f62d0fc5-f39b-40d7-a79f-29fca72966fe 55154-2087 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100907 ANDA ANDA076813 Cardinal Health ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 55154-2088_f62d0fc5-f39b-40d7-a79f-29fca72966fe 55154-2088 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100907 ANDA ANDA076813 Cardinal Health ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 55154-2089_12ea6a0b-fa9d-4c13-a495-038f795f7e77 55154-2089 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101014 ANDA ANDA078243 Cardinal Health LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55154-2090_f78baa0f-8b79-494a-9de8-a4aad717e547 55154-2090 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20100121 ANDA ANDA076368 Cardinal Health POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 55154-2094_4fccfd6e-711f-4a0b-ad27-eda9a5c355b4 55154-2094 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20100114 ANDA ANDA040742 Cardinal Health BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20191231 55154-2097_fb3d8b1e-45d2-4ae4-ab22-6c31f9014d1d 55154-2097 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100115 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 55154-2098_c185561b-8a18-412e-9bfb-50d2c6f11de4 55154-2098 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100813 ANDA ANDA090615 Cardinal Health METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-2099_c185561b-8a18-412e-9bfb-50d2c6f11de4 55154-2099 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100813 ANDA ANDA090615 Cardinal Health METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-2305_7c7cae76-b83e-44a0-857c-192b28e6f504 55154-2305 HUMAN PRESCRIPTION DRUG Asacol mesalamine TABLET, DELAYED RELEASE ORAL 19920401 NDA NDA019651 Cardinal Health MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 55154-2350_9ab50557-72a0-47ee-90c6-ef2b0c19923e 55154-2350 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100729 ANDA ANDA062933 Cardinal Health VANCOMYCIN HYDROCHLORIDE 1 g/250mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 55154-2351_9ab50557-72a0-47ee-90c6-ef2b0c19923e 55154-2351 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100729 ANDA ANDA062931 Cardinal Health VANCOMYCIN HYDROCHLORIDE 500 mg/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 55154-2353_0ff5aa5a-a12b-4b6e-9e22-5b01520c9d59 55154-2353 HUMAN PRESCRIPTION DRUG Metoclopramide METOCLOPRAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090922 ANDA ANDA073118 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 5 mg/mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20191231 55154-2359_eb0bf16b-8747-4070-baaa-d32085cb029f 55154-2359 HUMAN PRESCRIPTION DRUG Depakote Divalproex sodium TABLET, EXTENDED RELEASE ORAL 20100607 NDA NDA021168 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55154-2364_c9d423ac-df27-4b8d-bf2d-b2ca4184ab21 55154-2364 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100713 NDA AUTHORIZED GENERIC NDA018667 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-2365_5543cc36-2891-4e7a-83c0-8b54d933e69d 55154-2365 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100713 NDA AUTHORIZED GENERIC NDA018667 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-2366_aa4b12fd-8cd7-452e-b326-c538c2830290 55154-2366 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline Dihydrate INJECTION, SOLUTION INTRAVENOUS 20110211 ANDA ANDA087242 Cardinal Health AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20191231 55154-2367_11796698-4626-4912-b584-185003f40317 55154-2367 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19720316 ANDA ANDA080205 Cardinal Health POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 55154-2371_4e501728-2c92-4b0a-9ec9-4300094e5086 55154-2371 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100330 ANDA ANDA088299 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-2372_dbdf706d-8fda-4fac-93cd-0c4bfb7220b7 55154-2372 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION EPIDURAL; INFILTRATION 20100330 ANDA ANDA088329 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-2373_4e501728-2c92-4b0a-9ec9-4300094e5086 55154-2373 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100330 ANDA ANDA088327 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-2375_18ff4820-4f1d-4a36-8800-3b0e189a97af 55154-2375 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089644 Cardinal Health LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 10; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55154-2376_f61ae34a-0fdc-42a6-972d-ad93a3e1182f 55154-2376 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089644 Cardinal Health LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 10; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 55154-2379_f8b8e684-1408-444a-9858-17e411a08337 55154-2379 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110915 NDA NDA018801 Cardinal Health WATER 50 mL/50mL E 20171231 55154-2380_7b6bb9e9-4e5e-4e01-9077-0a4182a85e91 55154-2380 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20091207 ANDA ANDA089522 Cardinal Health HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 55154-2381_172d5200-3781-4bae-9920-76d60bc8d6f5 55154-2381 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION ENDOTRACHEAL; INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20130508 20180831 UNAPPROVED DRUG OTHER Cardinal Health EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55154-2385_e78bfa6d-d257-46a0-84a7-8d722c58830d 55154-2385 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100729 ANDA ANDA062933 Cardinal Health VANCOMYCIN HYDROCHLORIDE 1 g/250mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 55154-2388_745a8cf5-721f-43f7-a421-e4028ccc940b 55154-2388 HUMAN PRESCRIPTION DRUG Vitamin K1 PHYTONADIONE INJECTION, EMULSION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110824 ANDA ANDA087954 Cardinal Health PHYTONADIONE 2 mg/mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 55154-2391_0925a9d4-d625-48bf-af8a-902f32db593c 55154-2391 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100713 NDA AUTHORIZED GENERIC NDA018667 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-2392_6d374a95-f84d-4fd6-995b-aac201005974 55154-2392 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19830815 ANDA ANDA062420 Cardinal Health GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 55154-2393_519b98cb-e1bc-4143-9508-85d8cc985d2b 55154-2393 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100604 ANDA ANDA062912 Cardinal Health VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 55154-2395_e76fd5af-a363-4776-a517-4d4fe657608a 55154-2395 HUMAN PRESCRIPTION DRUG GENGRAF cyclosporine CAPSULE ORAL 20100524 ANDA ANDA065003 Cardinal Health CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55154-2398_519b98cb-e1bc-4143-9508-85d8cc985d2b 55154-2398 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100604 ANDA ANDA062911 Cardinal Health VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 55154-2429_20a70e70-df70-4afe-8678-ed3c9f12d787 55154-2429 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 Cardinal Health PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 55154-2430_8c2f7fd0-fd6f-420b-8366-9aaf994f7a83 55154-2430 HUMAN PRESCRIPTION DRUG Lyrica pregabalin CAPSULE ORAL 20041230 NDA NDA021724 Cardinal Health PREGABALIN 50 mg/1 CV N 20181231 55154-2431_8c2f7fd0-fd6f-420b-8366-9aaf994f7a83 55154-2431 HUMAN PRESCRIPTION DRUG Lyrica pregabalin CAPSULE ORAL 20041230 NDA NDA021724 Cardinal Health PREGABALIN 75 mg/1 CV N 20181231 55154-2432_8c2f7fd0-fd6f-420b-8366-9aaf994f7a83 55154-2432 HUMAN PRESCRIPTION DRUG Lyrica pregabalin CAPSULE ORAL 20041230 NDA NDA021724 Cardinal Health PREGABALIN 100 mg/1 CV N 20181231 55154-2433_62816aac-6454-4b0b-8ec6-4209d07e7b59 55154-2433 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Cardinal Health NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 55154-2451_83cfa7e2-3375-469d-bf5c-e77129300329 55154-2451 HUMAN PRESCRIPTION DRUG AcipHex rabeprazole sodium TABLET, COATED ORAL 19990819 NDA NDA020973 Cardinal Health RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 55154-2539_fb024857-1f1a-41ae-8046-484ddef0f19b 55154-2539 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20100212 20181231 ANDA ANDA201451 Cardinal Health MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 55154-2650_088a9538-4d8a-47e0-a0aa-fa24d07b6210 55154-2650 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19820101 ANDA ANDA062031 Cardinal Health DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 55154-2653_088a9538-4d8a-47e0-a0aa-fa24d07b6210 55154-2653 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19830202 ANDA ANDA062421 Cardinal Health DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 55154-2675_b068dee0-2ae8-456f-a77f-b598997b4057 55154-2675 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20110615 ANDA ANDA091195 Cardinal Health TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 55154-2676_b068dee0-2ae8-456f-a77f-b598997b4057 55154-2676 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20110615 ANDA ANDA091195 Cardinal Health TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 55154-2713_92235375-ee38-49cb-9906-b547fd0d7392 55154-2713 HUMAN PRESCRIPTION DRUG Zithromax azithromycin TABLET, FILM COATED ORAL 19960718 NDA NDA050711 Cardinal Health AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 55154-2725_c9a9b2de-dae1-411c-a13e-8b445ff993ff 55154-2725 HUMAN PRESCRIPTION DRUG VFEND voriconazole TABLET, FILM COATED ORAL 20020524 NDA NDA021266 Cardinal Health VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 55154-2734_5256084d-8908-43cf-bf3d-c4db7da1ba4a 55154-2734 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20110721 NDA NDA201370 Cardinal Health HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] E 20171231 55154-2736_0f183619-5afa-49db-b134-ea35d934d2f8 55154-2736 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 20220228 NDA NDA020895 Cardinal Health SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 55154-2737_fbea6a84-f942-419b-b7d2-7343df599161 55154-2737 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081031 NDA NDA022030 Cardinal Health FESOTERODINE FUMARATE 4 mg/1 N 20191231 55154-2738_fbea6a84-f942-419b-b7d2-7343df599161 55154-2738 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081031 NDA NDA022030 Cardinal Health FESOTERODINE FUMARATE 8 mg/1 N 20191231 55154-2826_63b510e8-c267-48b4-85f9-ba24bdca6d61 55154-2826 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090808 Cardinal Health HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 55154-2827_63b510e8-c267-48b4-85f9-ba24bdca6d61 55154-2827 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100706 ANDA ANDA090808 Cardinal Health HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 55154-2828_c0b1b4a6-8458-4cc4-a146-f5346764903e 55154-2828 HUMAN PRESCRIPTION DRUG Clindamycin clindamycin phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120515 ANDA ANDA090108 Cardinal Health CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 55154-2857_e0df89e4-1642-4c73-bf8d-9c1d3ac370fc 55154-2857 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101217 NDA NDA017558 Cardinal Health GLYCOPYRROLATE .2 mg/mL E 20171231 55154-2859_e0df89e4-1642-4c73-bf8d-9c1d3ac370fc 55154-2859 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101217 NDA NDA017558 Cardinal Health GLYCOPYRROLATE .2 mg/mL E 20171231 55154-2860_8e57779f-bcb1-41a4-aa9e-893c97b3b768 55154-2860 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 55154-2861_30bb19f8-f3ac-40b4-ad37-106de939d1a0 55154-2861 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 55154-2867_6010afb7-7f94-4c5e-a93b-1962f071c031 55154-2867 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20100304 ANDA ANDA075243 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-2869_e0df89e4-1642-4c73-bf8d-9c1d3ac370fc 55154-2869 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101217 NDA NDA017558 Cardinal Health GLYCOPYRROLATE .2 mg/mL E 20171231 55154-2872_d337b07d-5d72-428d-ac31-d8afbfd3b44b 55154-2872 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101119 ANDA ANDA077541 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 55154-2873_d337b07d-5d72-428d-ac31-d8afbfd3b44b 55154-2873 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101119 ANDA ANDA077541 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 55154-2874_6010afb7-7f94-4c5e-a93b-1962f071c031 55154-2874 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20100304 ANDA ANDA075243 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-2876_ac21a643-da05-4819-bbdc-977697bf4cb0 55154-2876 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077541 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55154-2877_3aafa187-bacf-4de7-ba5c-6b9bc41e372c 55154-2877 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077541 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55154-2885_e479e059-e5cf-42df-a3b0-bc408b8fae68 55154-2885 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710304 NDA NDA016673 Cardinal Health DEXTROSE MONOHYDRATE 50 g/1000mL N 20191231 55154-2886_d66b59bb-5a25-464f-b726-5d3939a0463d 55154-2886 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710304 NDA NDA016673 Cardinal Health DEXTROSE MONOHYDRATE 50 g/1000mL N 20191231 55154-2887_4bdd5269-ed2c-47cb-b2ae-e7f2053480fa 55154-2887 HUMAN PRESCRIPTION DRUG DEXTROSE DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 19710304 NDA NDA016673 Cardinal Health DEXTROSE MONOHYDRATE 50 g/1000mL N 20191231 55154-2888_5465feaf-c781-4b25-9793-6bcd8355cd81 55154-2888 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride Esmolol Hydrochloride INJECTION INTRAVENOUS 19861231 NDA NDA019386 Cardinal Health ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 55154-2889_1ef1032e-89bb-41ce-9f14-717423d559e1 55154-2889 HUMAN PRESCRIPTION DRUG Midazolam Midazolam INJECTION INTRAMUSCULAR; INTRAVENOUS 20000620 ANDA ANDA075243 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-3116_cc30c3e5-4d3a-4a89-8723-99c45b6f3c74 55154-3116 HUMAN PRESCRIPTION DRUG Klonopin clonazepam TABLET ORAL 19820101 NDA NDA017533 Cardinal Health CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-3117_cc30c3e5-4d3a-4a89-8723-99c45b6f3c74 55154-3117 HUMAN PRESCRIPTION DRUG Klonopin clonazepam TABLET ORAL 19820101 NDA NDA017533 Cardinal Health CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-3182_f61ae34a-0fdc-42a6-972d-ad93a3e1182f 55154-3182 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089646 Cardinal Health LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 20; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 55154-3183_32e206c0-426b-436e-8512-4dc4ee898764 55154-3183 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 19821029 NDA NDA018800 Cardinal Health SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55154-3186_28b16c0f-70c1-492d-b95b-2a9b36de85f0 55154-3186 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION ENDOTRACHEAL; INTRACARDIAC; INTRAVENOUS 19850405 UNAPPROVED DRUG OTHER Cardinal Health EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55154-3187_dbdf706d-8fda-4fac-93cd-0c4bfb7220b7 55154-3187 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA080408 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-3188_246d77b1-e50a-4ff7-b368-69898cd8b889 55154-3188 HUMAN PRESCRIPTION DRUG Calcium Chloride CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS; INTRAVENTRICULAR 19840917 20190430 UNAPPROVED DRUG OTHER Cardinal Health CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 55154-3189_da8d2eda-1db9-4a76-9ecf-86363604ff33 55154-3189 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20101129 ANDA ANDA040302 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-3190_da8d2eda-1db9-4a76-9ecf-86363604ff33 55154-3190 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20101129 ANDA ANDA083158 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-3192_3d28e213-4643-4fd7-ad87-5911f89368ef 55154-3192 HUMAN PRESCRIPTION DRUG Mannitol MANNITOL INJECTION, SOLUTION INTRAVENOUS 20100201 NDA NDA016269 Cardinal Health MANNITOL 12.5 g/50mL Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] N 20181231 55154-3193_5803a826-365f-4a07-9304-d7f7e065ee3a 55154-3193 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19881120 ANDA ANDA040140 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 55154-3194_742eae0a-653c-40f7-b822-18fe5c88dd09 55154-3194 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20091117 ANDA ANDA040078 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-3195_28b16c0f-70c1-492d-b95b-2a9b36de85f0 55154-3195 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION ENDOTRACHEAL; INTRACARDIAC; INTRAVENOUS 19850501 UNAPPROVED DRUG OTHER Cardinal Health EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55154-3196_50c892a3-f0c2-4912-9a76-b59f5af507b1 55154-3196 HUMAN PRESCRIPTION DRUG Calcium Chloride CALCIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110309 NDA NDA021117 Cardinal Health CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20191231 55154-3197_a9a95fc3-d6da-4657-916f-5c7534309e62 55154-3197 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19850418 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE 84 mg/mL N 20181231 55154-3227_1fc6eff1-e9b2-4034-b9ef-53032a330bd4 55154-3227 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110502 ANDA ANDA040737 Cardinal Health PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 55154-3326_b04c23ee-3165-4eb7-86a9-ca457747539e 55154-3326 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20100504 ANDA ANDA075757 Cardinal Health OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 55154-3327_f8c27119-357d-47b4-b7c7-72f91158f218 55154-3327 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Cardinal Health ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55154-3328_d073a176-61fa-4237-9524-dd03c970f3e5 55154-3328 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20090825 ANDA ANDA075604 Cardinal Health POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55154-3329_e74a979c-859a-427a-aebd-e44a5376b4a0 55154-3329 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20091102 ANDA ANDA078216 Cardinal Health CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-3330_5d0efc2b-9ab4-4e7d-9283-01b0ec035d6c 55154-3330 HUMAN PRESCRIPTION DRUG Pantoprazole Pantoprazole TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA077619 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 55154-3331_5ed5959e-803c-4ac6-86af-24171bfddd0f 55154-3331 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Cardinal Health LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-3336_5ed5959e-803c-4ac6-86af-24171bfddd0f 55154-3336 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Cardinal Health LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-3338_f13b6e92-52cb-4383-b42a-bb0a236c8998 55154-3338 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110607 ANDA ANDA091267 Cardinal Health DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 55154-3342_b6625089-0629-4f6e-8164-0b582c56d475 55154-3342 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-3343_b6625089-0629-4f6e-8164-0b582c56d475 55154-3343 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-3344_b6625089-0629-4f6e-8164-0b582c56d475 55154-3344 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-3346_5ed5959e-803c-4ac6-86af-24171bfddd0f 55154-3346 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Cardinal Health LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-3348_7023608c-9cb7-4b2b-bbba-009c806b895c 55154-3348 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20080228 ANDA ANDA076048 Cardinal Health OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55154-3349_e74a979c-859a-427a-aebd-e44a5376b4a0 55154-3349 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20091102 ANDA ANDA078216 Cardinal Health CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-3350_78162da6-ad65-4dd8-ab1a-6f77670fede9 55154-3350 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080801 ANDA ANDA076341 Cardinal Health PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-3375_d97b9069-b5a4-4027-9c8c-f40d735eaac9 55154-3375 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20090610 ANDA ANDA077002 Cardinal Health DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 55154-3376_316ea83d-c7ac-49f4-a62d-c976a0a5fa37 55154-3376 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET ORAL 20120517 ANDA ANDA090844 Cardinal Health CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 55154-3377_f58abc7f-4cae-4301-9be3-968cf690c14e 55154-3377 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090820 ANDA ANDA078705 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55154-3378_f13b6e92-52cb-4383-b42a-bb0a236c8998 55154-3378 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110607 ANDA ANDA091267 Cardinal Health DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 55154-3379_1b819850-1ca0-4c04-88ee-fa671aa514be 55154-3379 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 55154-3380_1b819850-1ca0-4c04-88ee-fa671aa514be 55154-3380 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 55154-3381_1b819850-1ca0-4c04-88ee-fa671aa514be 55154-3381 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 55154-3382_e1905561-7322-4839-acab-93301ddf03c9 55154-3382 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078865 Cardinal Health VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-3383_e1905561-7322-4839-acab-93301ddf03c9 55154-3383 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078865 Cardinal Health VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-3384_b6625089-0629-4f6e-8164-0b582c56d475 55154-3384 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120315 ANDA ANDA077565 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-3386_946133ff-67c8-4d3f-8dd4-6d1e72f87f1d 55154-3386 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19980721 ANDA ANDA072235 Cardinal Health BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 55154-3387_8ec58698-6b12-4c33-8285-737bf11798de 55154-3387 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20081030 ANDA ANDA040733 Cardinal Health DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 55154-3388_823a701b-77d0-4c76-8020-1084f03b9a76 55154-3388 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET ORAL 20110602 OTC MONOGRAPH NOT FINAL part334 Cardinal Health BISACODYL 5 mg/1 E 20171231 55154-3392_a27c8d30-fa25-4927-86fd-fdcfec8fd03a 55154-3392 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20090610 ANDA ANDA078500 Cardinal Health AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 55154-3393_f3f8162f-7c8b-4ec3-9dc3-cbf79b9eefb7 55154-3393 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101005 ANDA ANDA090615 Cardinal Health METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-3394_2e10a8c7-fa76-405c-b1af-5beff0bcd5f6 55154-3394 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Cardinal Health SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-3395_2e10a8c7-fa76-405c-b1af-5beff0bcd5f6 55154-3395 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Cardinal Health SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-3396_9963c228-135c-4732-b6e9-64f072d98b0d 55154-3396 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20080326 NDA NDA018569 Cardinal Health FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-3400_7a4e06b0-5023-4390-83b0-366340b07db6 55154-3400 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20150625 ANDA ANDA076658 Cardinal Health FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 55154-3416_21a488ce-0528-41e2-aa39-3862cc4c262d 55154-3416 HUMAN PRESCRIPTION DRUG Fioricet Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19841109 ANDA ANDA088616 Cardinal Health BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 55154-3418_139cec0c-481d-4a41-89dd-d51f236cc5cc 55154-3418 HUMAN PRESCRIPTION DRUG Neoral cyclosporine CAPSULE, LIQUID FILLED ORAL 19950714 NDA NDA050715 Cardinal Health CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 55154-3424_076ed195-253b-4b31-8a92-f134dfee6315 55154-3424 HUMAN PRESCRIPTION DRUG Clozaril clozapine TABLET ORAL 19890930 NDA NDA019758 Cardinal Health CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-3428_66d63267-2eb7-4024-9061-a976168a9f06 55154-3428 HUMAN PRESCRIPTION DRUG Comtan entacapone TABLET, FILM COATED ORAL 20000101 NDA NDA020796 Cardinal Health ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] E 20171231 55154-3432_b0acdcad-0d6d-4edc-a31f-7b1e3ab65ffc 55154-3432 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Cardinal Health AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 55154-3488_5c00ae98-aaea-4c67-b8a8-71be09920b06 55154-3488 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA091023 Cardinal Health CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 55154-3495_b711895f-e3d4-43f2-9a3d-1841825fca21 55154-3495 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20061226 ANDA ANDA076183 Cardinal Health ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 55154-3526_abcfeec6-7f3a-4139-a6e6-fa42dafd8264 55154-3526 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 19881208 ANDA ANDA089683 Cardinal Health PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 55154-3580_e3120f01-d910-4641-b4da-0d16d5a16483 55154-3580 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-3581_e3120f01-d910-4641-b4da-0d16d5a16483 55154-3581 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Cardinal Health GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-3582_e3120f01-d910-4641-b4da-0d16d5a16483 55154-3582 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Cardinal Health GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-3586_7a57215e-cae9-4fbd-aa33-53f3f06e2276 55154-3586 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Cardinal Health METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 55154-3587_7a57215e-cae9-4fbd-aa33-53f3f06e2276 55154-3587 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Cardinal Health METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 55154-3588_7a57215e-cae9-4fbd-aa33-53f3f06e2276 55154-3588 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Cardinal Health METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 55154-3593_e274bd23-5747-409b-8db4-02fa8f3ded16 55154-3593 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Cardinal Health QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-3594_e274bd23-5747-409b-8db4-02fa8f3ded16 55154-3594 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Cardinal Health QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-3595_e274bd23-5747-409b-8db4-02fa8f3ded16 55154-3595 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Cardinal Health QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-3621_839cbcbd-7642-4971-873b-801863c48b5f 55154-3621 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Cardinal Health CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 55154-3622_839cbcbd-7642-4971-873b-801863c48b5f 55154-3622 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Cardinal Health CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 55154-3625_669e7793-d216-42ce-b8d4-616dc506d5c8 55154-3625 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Cardinal Health CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 55154-3650_bc98621b-1cd5-4ee8-9f15-f90946dd39a9 55154-3650 HUMAN PRESCRIPTION DRUG Skelaxin Metaxalone TABLET ORAL 20020830 NDA NDA013217 Cardinal Health METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 55154-3675_ac75341f-e96e-435c-9522-b2c4d413eedb 55154-3675 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 55154-3680_1a01309f-e590-4e86-a74c-2c56fbcd5d15 55154-3680 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Cardinal Health ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55154-3682_155d9cbb-c74c-49b0-840d-fd79c0f13e4f 55154-3682 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Cardinal Health CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 55154-3683_c8a7b1cf-94ed-4b18-8330-e2a7dd1925c2 55154-3683 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Cardinal Health ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 55154-3728_9b3adf55-3542-4729-b481-c2e538f7cf06 55154-3728 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070727 ANDA ANDA077851 Cardinal Health ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 55154-3825_243c8aa8-a3e6-406e-bff8-3d72095d65bc 55154-3825 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Cardinal Health LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-3826_243c8aa8-a3e6-406e-bff8-3d72095d65bc 55154-3826 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Cardinal Health LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-3875_bd53e4c0-cc40-4008-b238-5554ef047522 55154-3875 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Cardinal Health SOLIFENACIN SUCCINATE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 55154-3876_bd53e4c0-cc40-4008-b238-5554ef047522 55154-3876 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Cardinal Health SOLIFENACIN SUCCINATE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 55154-3877_f394c585-7416-4b40-8853-f5ac2fa8f425 55154-3877 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Cardinal Health SOLIFENACIN SUCCINATE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 55154-3878_f394c585-7416-4b40-8853-f5ac2fa8f425 55154-3878 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Cardinal Health SOLIFENACIN SUCCINATE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 55154-3925_b2b4c961-363d-49fe-b354-d59b39fd517a 55154-3925 HUMAN PRESCRIPTION DRUG SOLU-CORTEF hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVASCULAR 19550427 NDA NDA009866 Cardinal Health HYDROCORTISONE SODIUM SUCCINATE 100 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 55154-3929_fbfafe5e-6639-4d1e-9b4f-202cab983dc1 55154-3929 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 19590528 NDA NDA011757 Cardinal Health METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 55154-3932_fbfafe5e-6639-4d1e-9b4f-202cab983dc1 55154-3932 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 19590528 NDA NDA011757 Cardinal Health METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 55154-3933_aea9002b-1e7e-4b23-b6d5-5980be46e76b 55154-3933 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20001222 NDA NDA021228 Cardinal Health TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 55154-3935_aea9002b-1e7e-4b23-b6d5-5980be46e76b 55154-3935 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20001222 NDA NDA021228 Cardinal Health TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 55154-3938_d76293c8-2642-4bfc-97bf-59e37251723d 55154-3938 HUMAN PRESCRIPTION DRUG Zyvox linezolid TABLET, FILM COATED ORAL 20000418 NDA NDA021130 Cardinal Health LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] E 20171231 55154-3939_47387477-9a24-46bd-8203-bc9528655412 55154-3939 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55154-3940_2ada7d12-100a-4211-9e1c-d8db626e4c85 55154-3940 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55154-3941_2ada7d12-100a-4211-9e1c-d8db626e4c85 55154-3941 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55154-3942_e0208d94-c6e5-413b-a10f-a67bf9333fe6 55154-3942 HUMAN PRESCRIPTION DRUG Solu-Cortef hydrocortisone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19550427 NDA NDA009866 Cardinal Health HYDROCORTISONE SODIUM SUCCINATE 100 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55154-3944_1f4207d7-c79f-43d2-a04b-bfcedbc63344 55154-3944 HUMAN PRESCRIPTION DRUG Solu-Medrol methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55154-3950_3782bd67-1774-4b93-a08b-e6beb16827ae 55154-3950 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 55154-3951_3782bd67-1774-4b93-a08b-e6beb16827ae 55154-3951 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 55154-3952_d5c08694-4710-4785-a3db-58f5033d8264 55154-3952 HUMAN PRESCRIPTION DRUG Phytonadione Phytonadione INJECTION, EMULSION PARENTERAL 20030418 ANDA ANDA083722 Cardinal Health PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] E 20171231 55154-3953_bf08d347-dd75-4cad-acbc-d76c225bac14 55154-3953 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 55154-3954_3a9f8a0d-97b2-4265-b96f-a11ee90f3d5c 55154-3954 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 20010601 ANDA ANDA072076 Cardinal Health NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20191231 55154-3955_bf08d347-dd75-4cad-acbc-d76c225bac14 55154-3955 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 55154-4024_86722a67-521c-4c0c-b01e-ee4e65864857 55154-4024 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-4028_86722a67-521c-4c0c-b01e-ee4e65864857 55154-4028 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-4029_86722a67-521c-4c0c-b01e-ee4e65864857 55154-4029 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-4030_86722a67-521c-4c0c-b01e-ee4e65864857 55154-4030 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-4031_86722a67-521c-4c0c-b01e-ee4e65864857 55154-4031 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-4033_2cafe437-4f2e-46c3-8859-c6d740be90d3 55154-4033 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 55154-4034_2cafe437-4f2e-46c3-8859-c6d740be90d3 55154-4034 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 55154-4035_2cafe437-4f2e-46c3-8859-c6d740be90d3 55154-4035 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 55154-4036_2cafe437-4f2e-46c3-8859-c6d740be90d3 55154-4036 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 55154-4037_2cafe437-4f2e-46c3-8859-c6d740be90d3 55154-4037 HUMAN PRESCRIPTION DRUG Lovenox enoxaparin sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 19930329 NDA NDA020164 Cardinal Health ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 55154-4056_6eb10247-087f-4ee4-9ad1-e595c116a632 55154-4056 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20100510 ANDA ANDA064142 Cardinal Health NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20191231 55154-4057_4937b200-d55c-40ac-8a7c-486458dce644 55154-4057 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate SUSPENSION ORAL 20120816 NDA NDA019183 Cardinal Health SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20191231 55154-4058_0d41e820-f8d9-4ef3-b47f-08e2bc78191a 55154-4058 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 20120220 ANDA ANDA200343 Cardinal Health HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 55154-4059_34ae5267-acb0-4adf-930c-fb1eafb5c8bc 55154-4059 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20100510 ANDA ANDA064142 Cardinal Health NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 55154-4060_8cd561ce-8c0a-4c93-a3bd-80d7adc660da 55154-4060 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20120816 ANDA ANDA074978 Cardinal Health IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 55154-4179_783f05ed-eba9-46f3-af20-9f51daaac786 55154-4179 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Cardinal Health HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 55154-4180_783f05ed-eba9-46f3-af20-9f51daaac786 55154-4180 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Cardinal Health HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 55154-4183_927d544d-04f7-4ac2-b593-eda862dcc797 55154-4183 HUMAN PRESCRIPTION DRUG Prochlorperazine Edisylate Prochlorperazine Edisylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20120326 ANDA ANDA204147 Cardinal Health PROCHLORPERAZINE EDISYLATE 5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 55154-4184_bab33a73-36dd-4139-87a1-7ef98897df88 55154-4184 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE, LIQUID FILLED ORAL 20080321 ANDA ANDA076740 Cardinal Health NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 55154-4217_e9808de4-351d-49d6-8602-3b3999ecfe6b 55154-4217 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20000501 NDA NDA020987 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 55154-4218_1f8f63a5-0e05-4643-8f9a-ee1292931451 55154-4218 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Cardinal Health VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-4219_1f8f63a5-0e05-4643-8f9a-ee1292931451 55154-4219 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Cardinal Health VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-4223_1f8f63a5-0e05-4643-8f9a-ee1292931451 55154-4223 HUMAN PRESCRIPTION DRUG Effexor XR venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Cardinal Health VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-4225_67977cc9-c07c-4952-9883-176697da2baa 55154-4225 HUMAN PRESCRIPTION DRUG Protonix I.V. pantoprazole sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010501 NDA NDA020988 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55154-4226_e9808de4-351d-49d6-8602-3b3999ecfe6b 55154-4226 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20000501 NDA NDA020987 Cardinal Health PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 55154-4227_0f26220a-f4ab-4ceb-9a98-a13dbdeed81f 55154-4227 HUMAN PRESCRIPTION DRUG Rapamune Sirolimus TABLET, SUGAR COATED ORAL 20010701 NDA NDA021110 Cardinal Health SIROLIMUS 1 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] E 20171231 55154-4228_db7aa1c2-22e6-492f-81ba-5ecbb8836ac0 55154-4228 HUMAN PRESCRIPTION DRUG Zosyn piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19931101 NDA NDA050684 Cardinal Health TAZOBACTAM SODIUM; PIPERACILLIN SODIUM .375; 3 g/15mL; g/15mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 55154-4230_6f5330bf-1c93-4769-82ec-de5a53c87172 55154-4230 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20080501 NDA NDA021992 Cardinal Health DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 55154-4232_e9808de4-351d-49d6-8602-3b3999ecfe6b 55154-4232 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release pantoprazole sodium GRANULE, DELAYED RELEASE ORAL 20080229 NDA NDA022020 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 55154-4233_15a606c5-e396-4b1f-aec6-0b92080b7e2b 55154-4233 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 55154-4234_b3ab36cf-7e71-4812-badf-529a6cde46e5 55154-4234 HUMAN PRESCRIPTION DRUG Protonix I.V. pantoprazole sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010501 NDA NDA020988 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 55154-4235_6f5330bf-1c93-4769-82ec-de5a53c87172 55154-4235 HUMAN PRESCRIPTION DRUG Pristiq Extended-Release desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20080501 NDA NDA021992 Cardinal Health DESVENLAFAXINE SUCCINATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 55154-4236_088a7b08-c328-4e65-bcd7-36c2ebbfd4ad 55154-4236 HUMAN PRESCRIPTION DRUG Protonix I.V. PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20010501 NDA NDA020988 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/10mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55154-4250_a91f6d42-e74e-461b-af00-44a118ecc502 55154-4250 HUMAN PRESCRIPTION DRUG Cardizem diltiazem hydrochloride CAPSULE ORAL 20010411 NDA NDA020062 Cardinal Health DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 55154-4251_a91f6d42-e74e-461b-af00-44a118ecc502 55154-4251 HUMAN PRESCRIPTION DRUG Cardizem diltiazem hydrochloride CAPSULE ORAL 20010411 NDA NDA020062 Cardinal Health DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 55154-4325_16d4ec47-fbfe-4c18-b0fe-d4def625b4c3 55154-4325 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20110805 ANDA ANDA040782 Cardinal Health DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 55154-4326_c6b1bbe5-78b0-407f-b953-92a131e3a4aa 55154-4326 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110607 ANDA ANDA078500 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 55154-4327_d4c9fcbc-348b-4279-880d-ffdc8c984bbe 55154-4327 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20110520 ANDA ANDA065404 Cardinal Health AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 55154-4329_1e7df8a2-4632-4848-bf9b-9f1435bc3950 55154-4329 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20130502 ANDA ANDA075090 Cardinal Health ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 55154-4330_10207cb9-3e07-4627-96e0-b57dd688784d 55154-4330 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130115 ANDA ANDA078281 Cardinal Health PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55154-4331_9e7091c5-9cf4-434a-a926-d924d9c8871e 55154-4331 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140110 ANDA ANDA078552 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55154-4332_8b98de03-d0a5-4807-a238-fc028edaa0af 55154-4332 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19990305 ANDA ANDA075382 Cardinal Health ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 55154-4333_73a74ee7-97f1-4bb5-8c0e-40a51257b6cf 55154-4333 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140326 ANDA ANDA065507 Cardinal Health AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 55154-4336_5dad3a35-b0c4-43e2-a9da-9b9390143730 55154-4336 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140912 ANDA ANDA090836 Cardinal Health CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55154-4350_59579b2f-761a-4d01-b335-d54565c8f1e4 55154-4350 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20010626 ANDA ANDA075664 Cardinal Health ALBUTEROL SULFATE 2.5 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 55154-4351_f8b04664-777d-478a-bb56-621845e3cb99 55154-4351 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20010927 ANDA ANDA075562 Cardinal Health IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 55154-4352_5df7f00d-7a4c-4ed9-8591-ab3232d83da5 55154-4352 HUMAN OTC DRUG S2 racepinephrine hydrochloride SOLUTION RESPIRATORY (INHALATION) 20000101 OTC MONOGRAPH FINAL part341 Cardinal Health RACEPINEPHRINE HYDROCHLORIDE 11.25 mg/.5mL N 20191231 55154-4357_543d5d48-5ac1-4895-9d7d-29028c523c00 55154-4357 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20071231 ANDA ANDA076749 Cardinal Health IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 2.5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 55154-4358_04697ee2-238b-4b87-831f-4e78cf835514 55154-4358 HUMAN OTC DRUG Sodium Chloride Sodium Chloride INHALANT RESPIRATORY (INHALATION) 20110607 UNAPPROVED DRUG OTHER Cardinal Health SODIUM CHLORIDE .9 mg/100mL N 20181231 55154-4359_cca97c19-7c1b-4435-a297-d013a8ac97d8 55154-4359 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 Cardinal Health ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 55154-4360_52d729bc-dcb2-4396-8bb3-2d549fe49af6 55154-4360 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20040628 ANDA ANDA076355 Cardinal Health ALBUTEROL SULFATE 1.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 55154-4375_4465386f-0750-4607-9aac-51f79250597f 55154-4375 HUMAN OTC DRUG Loratadine loratadine TABLET ORAL 20130430 ANDA ANDA076154 Cardinal Health LORATADINE 10 mg/1 N 20181231 55154-4376_a6f1ed80-4b88-44f2-819a-9fb6293e5eff 55154-4376 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20101029 ANDA ANDA076187 Cardinal Health LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55154-4377_a6f1ed80-4b88-44f2-819a-9fb6293e5eff 55154-4377 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20101029 ANDA ANDA076187 Cardinal Health LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55154-4378_32e7d1a4-49c1-496a-b090-3d1da1703b18 55154-4378 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20140102 ANDA ANDA070184 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 55154-4379_4d0fb3f2-1a16-4cde-830f-a9f43246450d 55154-4379 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20130924 ANDA ANDA070848 Cardinal Health SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 55154-4380_7e72b04c-47d3-45f9-bc21-323a767b0467 55154-4380 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, FILM COATED ORAL 20120829 ANDA ANDA079103 Cardinal Health MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 55154-4381_a79ce973-1506-474e-ba2b-da7636423c07 55154-4381 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090203 ANDA ANDA077567 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55154-4382_8a04bbdb-a7c9-4510-ab56-c68a9a34d167 55154-4382 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20120905 ANDA ANDA090970 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55154-4383_32e7d1a4-49c1-496a-b090-3d1da1703b18 55154-4383 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20131230 ANDA ANDA072801 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 55154-4384_1ed43b27-1cc4-4058-a63c-67e0bd59291c 55154-4384 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20140123 ANDA ANDA091226 Cardinal Health ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55154-4385_cc966cb9-de0a-42a7-bbd4-789246657abe 55154-4385 HUMAN PRESCRIPTION DRUG Metoprolol Succinate metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120127 ANDA ANDA202033 Cardinal Health METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 55154-4386_94282f5a-5b41-4d3f-9d31-b5989a9f7459 55154-4386 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20141013 ANDA ANDA202640 Cardinal Health MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 55154-4388_cc966cb9-de0a-42a7-bbd4-789246657abe 55154-4388 HUMAN PRESCRIPTION DRUG Metoprolol Succinate metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120127 ANDA ANDA202033 Cardinal Health METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 55154-4390_6b44d5d8-91f6-45f4-bda3-e30ace140e86 55154-4390 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20150115 ANDA ANDA071017 Cardinal Health SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 55154-4391_6e6e6b4d-2c8e-4fd2-9397-96091e8b5ea6 55154-4391 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19981005 ANDA ANDA072575 Cardinal Health PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55154-4392_3adc336b-588e-4ca1-8c14-5b23836c948b 55154-4392 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100528 ANDA ANDA090325 Cardinal Health BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 55154-4393_a1cc3b2c-0ddd-4fda-9555-5b56257c6ac3 55154-4393 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20100614 ANDA ANDA040821 Cardinal Health GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 55154-4394_1fafb889-1b0b-431b-8048-25484fc54624 55154-4394 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000701 ANDA ANDA075491 Cardinal Health BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 55154-4395_c243cadc-482d-41a9-95c5-3d109072aef2 55154-4395 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20101101 ANDA ANDA090596 Cardinal Health TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 55154-4396_45a14bb3-eb3a-4f13-80ad-9b3c134b8af6 55154-4396 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20150713 ANDA ANDA077578 Cardinal Health FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 55154-4427_ac529edf-5634-49fa-8db5-ba3a39763161 55154-4427 HUMAN PRESCRIPTION DRUG Ranexa ranolazine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070212 NDA NDA021526 Cardinal Health RANOLAZINE 500 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 55154-4428_0c073e1d-cbef-42d8-bef2-cd965a14251f 55154-4428 HUMAN PRESCRIPTION DRUG Ranexa ranolazine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060127 NDA NDA021526 Cardinal Health RANOLAZINE 500 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 55154-4450_7c0a4559-feaf-4bf4-89f0-e0d017f57d77 55154-4450 HUMAN PRESCRIPTION DRUG Norepinephrine bitartrate Norepinephrine bitartrate INJECTION INTRAVENOUS 20120401 ANDA ANDA040859 Cardinal Health NOREPINEPHRINE BITARTRATE 1 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 55154-4451_9f201224-c115-42b4-8c1e-244504283eb5 55154-4451 HUMAN PRESCRIPTION DRUG Metoprolol metoprolol tartrate INJECTION INTRAVENOUS 20120925 ANDA ANDA078950 Cardinal Health METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-4452_2c744433-094e-42c0-a1ad-b3437e5804c0 55154-4452 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20140206 ANDA ANDA202747 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-4510_31525806-a798-48f6-8a8d-162ac81cb814 55154-4510 HUMAN PRESCRIPTION DRUG DYAZIDE hydrochlorothiazide and triamterene CAPSULE ORAL 19940330 NDA NDA016042 Cardinal Health HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] E 20171231 55154-4511_7b97ac91-9ed6-4cca-a517-fb1c2b3d0e46 55154-4511 HUMAN PRESCRIPTION DRUG AUGMENTIN amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19840806 NDA NDA050564 Cardinal Health AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 55154-4513_5abdce6e-3416-439b-8af1-77ee679f0ab2 55154-4513 HUMAN PRESCRIPTION DRUG AVANDIA rosiglitazone maleate TABLET, FILM COATED ORAL 19990529 NDA NDA021071 Cardinal Health ROSIGLITAZONE MALEATE 4 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 55154-4518_5abdce6e-3416-439b-8af1-77ee679f0ab2 55154-4518 HUMAN PRESCRIPTION DRUG AVANDIA rosiglitazone maleate TABLET, FILM COATED ORAL 19990528 NDA NDA021071 Cardinal Health ROSIGLITAZONE MALEATE 8 mg/1 Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 55154-4519_91b240f2-856c-44cf-a3de-a6ead2891f0d 55154-4519 HUMAN OTC DRUG Tums Calcium Carbonate TABLET ORAL 20110615 UNAPPROVED DRUG OTHER Cardinal Health CALCIUM CARBONATE 500 mg/1 E 20171231 55154-4522_2f8327e8-b25c-4e1f-9c2e-6892aa2e8f85 55154-4522 HUMAN PRESCRIPTION DRUG BACTROBAN mupirocin calcium OINTMENT TOPICAL 19960410 NDA NDA050703 Cardinal Health MUPIROCIN CALCIUM 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20191231 55154-4550_4d47d787-4cfd-4b2e-ba08-452168eff880 55154-4550 HUMAN PRESCRIPTION DRUG Myambutol Ethambutol Hydrochloride TABLET ORAL 20110627 NDA NDA016320 Cardinal Health ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] E 20171231 55154-4560_46027830-8992-457c-a448-88de995b4a00 55154-4560 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE ORAL 20070628 ANDA ANDA077067 Cardinal Health NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 55154-4563_0c965ac3-c462-4777-9482-569193bc880e 55154-4563 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Cardinal Health METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-4564_005a1ebe-bccf-47ce-a203-656854c70961 55154-4564 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Cardinal Health METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-4567_25414823-da45-484c-8c14-a52c44adfdc0 55154-4567 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Cardinal Health ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 55154-4575_d8aac420-c0d3-495a-9f23-775d17d1eaa2 55154-4575 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 NDA NDA020741 Cardinal Health REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] E 20171231 55154-4614_38ca3165-cd85-40b0-bf2e-57110585332e 55154-4614 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Cardinal Health ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-4615_06f2d964-a9fb-40ce-8206-304765d78e21 55154-4615 HUMAN PRESCRIPTION DRUG Namenda Memantine Hydrochloride TABLET ORAL 20031016 NDA NDA021487 Cardinal Health MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 55154-4616_38ca3165-cd85-40b0-bf2e-57110585332e 55154-4616 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Cardinal Health ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-4617_4cece242-c14b-4116-9101-711acbb90252 55154-4617 HUMAN PRESCRIPTION DRUG Namenda Memantine Hydrochloride TABLET ORAL 20031016 NDA NDA021487 Cardinal Health MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 55154-4618_4cece242-c14b-4116-9101-711acbb90252 55154-4618 HUMAN PRESCRIPTION DRUG Namenda Memantine Hydrochloride TABLET ORAL 20031016 NDA NDA021487 Cardinal Health MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 55154-4619_02194826-72a8-4436-9ade-e36fa5bb99da 55154-4619 HUMAN PRESCRIPTION DRUG Lexapro Escitalopram oxalate TABLET ORAL 20020814 NDA NDA021323 Cardinal Health ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-4620_02194826-72a8-4436-9ade-e36fa5bb99da 55154-4620 HUMAN PRESCRIPTION DRUG Lexapro Escitalopram oxalate TABLET ORAL 20020814 NDA NDA021323 Cardinal Health ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-4621_79cf6b35-c859-4b70-be84-ff4a95ada244 55154-4621 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Cardinal Health NEBIVOLOL HYDROCHLORIDE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-4622_79cf6b35-c859-4b70-be84-ff4a95ada244 55154-4622 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Cardinal Health NEBIVOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-4623_79cf6b35-c859-4b70-be84-ff4a95ada244 55154-4623 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Cardinal Health NEBIVOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-4624_e6da11db-7c1e-4086-a659-5359a3ca018a 55154-4624 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride TABLET ORAL 20110429 NDA NDA022567 Cardinal Health VILAZODONE HYDROCHLORIDE 40 mg/1 N 20181231 55154-4625_c4271d86-cc5f-4ed0-bf0d-fefcd6aa1e77 55154-4625 HUMAN PRESCRIPTION DRUG Daliresp roflumilast TABLET ORAL 20110228 NDA NDA022522 Cardinal Health ROFLUMILAST 500 ug/1 Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA] N 20191231 55154-4626_582cbeec-3aae-43be-a3f6-85110b614fa6 55154-4626 HUMAN PRESCRIPTION DRUG Savella milnacipran hydrochloride TABLET, FILM COATED ORAL 20090417 NDA NDA022256 Cardinal Health MILNACIPRAN HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-4627_e6da11db-7c1e-4086-a659-5359a3ca018a 55154-4627 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride TABLET ORAL 20110429 NDA NDA022567 Cardinal Health VILAZODONE HYDROCHLORIDE 20 mg/1 N 20181231 55154-4675_8d37f494-69ed-4a42-bd05-b83a64e96449 55154-4675 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20150601 ANDA ANDA203686 Cardinal Health METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 55154-4676_071120d6-973f-44d1-a5e5-d42264c19a58 55154-4676 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150220 ANDA ANDA202223 Cardinal Health VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55154-4677_45a1eaa7-96ab-47f9-a85a-3c26441bfcd7 55154-4677 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20150601 ANDA ANDA040627 Cardinal Health BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 55154-4678_071120d6-973f-44d1-a5e5-d42264c19a58 55154-4678 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150215 ANDA ANDA202223 Cardinal Health VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55154-4679_c1ab0571-ba93-40c9-acec-9982458ac05a 55154-4679 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141007 ANDA ANDA090554 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55154-4680_4fa2dc17-fc40-458c-8941-449eb5e1fc3b 55154-4680 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160101 NDA NDA021282 Cardinal Health GUAIFENESIN 600 mg/1 N 20181231 55154-4709_7b60c971-1a12-44db-8b54-335a516fe149 55154-4709 HUMAN OTC DRUG Colace docusate sodium CAPSULE ORAL 20110607 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM 50 mg/1 E 20171231 55154-4726_a3d56877-06d6-4407-81cd-b8483a79fd36 55154-4726 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 19980706 ANDA ANDA075160 Cardinal Health METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 55154-4727_044a19c9-0f21-4627-8c62-a5740ece4c2b 55154-4727 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100713 NDA AUTHORIZED GENERIC NDA018667 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-4730_5596a380-8439-4c55-800b-0a9a96ef6700 55154-4730 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION RETROBULBAR; TOPICAL 20100324 ANDA ANDA088295 Cardinal Health LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-4731_db4f834b-9882-438e-9c0b-210bba6b398e 55154-4731 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077548 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 55154-4732_09bdd6dd-5680-414f-9232-b4120fae39a6 55154-4732 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110708 ANDA ANDA070256 Cardinal Health NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20191231 55154-4733_6055eb84-a3a4-49fa-b97c-fcd802613e8a 55154-4733 HUMAN PRESCRIPTION DRUG Bumetanide BUMETANIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111116 ANDA ANDA074332 Cardinal Health BUMETANIDE .25 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 55154-4734_3e25ee1f-01d6-4651-9b1c-b2b69bf51e8c 55154-4734 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020722 ANDA ANDA075857 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-4735_56681b99-a586-467e-9cc0-41fdfc872fb3 55154-4735 HUMAN PRESCRIPTION DRUG DOPamine Hydrochloride Dopamine Hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19810519 NDA NDA018132 Cardinal Health DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 55154-4736_25446996-576c-4692-b25a-fb068409c0ca 55154-4736 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 20100107 ANDA ANDA070584 Cardinal Health BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55154-4737_7a761d17-564a-4a08-b648-11cae6456e39 55154-4737 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19840127 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE 42 mg/mL N 20191231 55154-4738_0a4bbd60-96d0-4de1-98cb-5eb26c589571 55154-4738 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19850501 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE 84 mg/mL N 20191231 55154-4739_3e5bb157-a56b-4c0d-8328-f2dc4f34a545 55154-4739 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110325 ANDA ANDA075136 Cardinal Health VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 55154-4740_a70a9886-743e-487c-883a-aaeebb62e0e8 55154-4740 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19860212 ANDA ANDA089070 Cardinal Health PROCAINAMIDE HYDROCHLORIDE 500 mg/mL Antiarrhythmic [EPC] E 20171231 55154-4741_96727f19-5b45-4bd5-a473-3a54f9cdbcbc 55154-4741 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20110318 NDA NDA016367 Cardinal Health DEXTROSE MONOHYDRATE 5 g/100mL E 20171231 55154-4743_8bf8a772-e189-4e36-b811-6b60d522558e 55154-4743 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020722 ANDA ANDA075857 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-4744_850a893d-934d-46d6-aab6-ee093e0bfc96 55154-4744 HUMAN PRESCRIPTION DRUG Meropenem MEROPENEM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100623 ANDA ANDA090940 Cardinal Health MEROPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] E 20171231 55154-4745_4f8ed01a-5a2c-428b-8572-774fb6acdca7 55154-4745 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate METOPROLOL TARTRATE INJECTION, SOLUTION INTRAVENOUS 20080429 ANDA ANDA078085 Cardinal Health METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-4746_b5634b35-252f-4fe6-8902-c3519ca380a4 55154-4746 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19880616 ANDA ANDA071165 Cardinal Health BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 55154-4747_eef3da85-7cb3-43d5-847a-580114541857 55154-4747 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 19991129 ANDA ANDA075239 Cardinal Health LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 55154-4748_4d2e915d-eba5-40c2-9429-1070d1eb0259 55154-4748 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride and Epinephrine BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 19880616 ANDA ANDA071165 Cardinal Health BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; 5 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 55154-4749_7587e18c-160d-4402-b696-b84124631ca0 55154-4749 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090831 ANDA ANDA090571 Cardinal Health HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20191231 55154-4750_b9c6e647-d23c-4026-abc2-49a555b4f3d6 55154-4750 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090311 NDA NDA018832 Cardinal Health ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20191231 55154-4752_ffdd10af-1054-4204-bd4d-c414e9d49f10 55154-4752 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20100609 ANDA ANDA076704 Cardinal Health METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 55154-4753_72ee50ed-cec5-4bf0-bd1d-b7efb569a1ea 55154-4753 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20110519 ANDA ANDA077584 Cardinal Health PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 55154-4756_ecba926d-1ab6-4267-974f-bcea2f712043 55154-4756 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20090105 ANDA ANDA077285 Cardinal Health BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 55154-4759_e2461383-f26f-4925-80f9-71dbcb24e68e 55154-4759 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM CAPSULE, COATED PELLETS ORAL 20090401 ANDA ANDA078919 Cardinal Health DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 55154-4760_8e4472fa-1cbe-45c5-b82e-e3c4ea2de140 55154-4760 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM EXTENDED-RELEASE DIVALPROEX SODIUM EXTENDED-RELEASE TABLET, EXTENDED RELEASE ORAL 20091014 ANDA ANDA078705 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55154-4761_b2a3c16b-cf37-42c1-bf20-2e679767a2ab 55154-4761 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55154-4762_bad170f2-b646-4ce1-8a77-c65f880b2ef0 55154-4762 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-4763_bad170f2-b646-4ce1-8a77-c65f880b2ef0 55154-4763 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-4764_bad170f2-b646-4ce1-8a77-c65f880b2ef0 55154-4764 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-4765_bad170f2-b646-4ce1-8a77-c65f880b2ef0 55154-4765 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-4767_940c1e94-4a6b-477a-94f4-e5f94131532f 55154-4767 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078865 Cardinal Health VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-4768_940c1e94-4a6b-477a-94f4-e5f94131532f 55154-4768 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078865 Cardinal Health VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-4769_940c1e94-4a6b-477a-94f4-e5f94131532f 55154-4769 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA078865 Cardinal Health VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-4770_a1205cde-9534-43a9-914e-ac4e75a78b0d 55154-4770 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20130702 ANDA ANDA077560 Cardinal Health ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-4772_a2dba360-51f1-4970-9ff1-5e30cc1b313d 55154-4772 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20120831 ANDA ANDA075694 Cardinal Health GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-4774_1dece64d-34bb-4da6-bb5d-84c294184998 55154-4774 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20110519 ANDA ANDA073554 Cardinal Health NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 55154-4775_5b0003d6-5329-4f5c-9a12-1380a1f36432 55154-4775 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060908 ANDA ANDA040596 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 55154-4777_7752c4ca-2ed7-4e9e-97aa-7669c5be00e2 55154-4777 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20070730 ANDA ANDA071826 Cardinal Health MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 55154-4778_c185561b-8a18-412e-9bfb-50d2c6f11de4 55154-4778 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100813 ANDA ANDA090615 Cardinal Health METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-4779_aafcc03e-b7d2-483a-8ace-4ff27cb768b3 55154-4779 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20130717 ANDA ANDA090509 Cardinal Health TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] E 20171231 55154-4781_963a7062-6e5a-4608-8ce7-12a6e13f43ec 55154-4781 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110502 ANDA ANDA078103 Cardinal Health SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-4782_963a7062-6e5a-4608-8ce7-12a6e13f43ec 55154-4782 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20110502 ANDA ANDA078103 Cardinal Health SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-4783_12ea6a0b-fa9d-4c13-a495-038f795f7e77 55154-4783 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101014 ANDA ANDA078243 Cardinal Health LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55154-4784_a93926b7-be06-4279-9e7a-a028fef44144 55154-4784 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20130524 ANDA ANDA077751 Cardinal Health PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55154-4785_4956d72e-4054-4863-831b-9833e90909a6 55154-4785 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130215 ANDA ANDA075155 Cardinal Health ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 55154-4786_4956d72e-4054-4863-831b-9833e90909a6 55154-4786 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130215 ANDA ANDA075155 Cardinal Health ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 55154-4787_62b2779c-46f2-4ea2-a1d2-c089333a4066 55154-4787 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121211 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 55154-4788_62b2779c-46f2-4ea2-a1d2-c089333a4066 55154-4788 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121212 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 55154-4789_98bef8a2-bf49-4756-bc31-18d9796151c5 55154-4789 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20121129 ANDA ANDA090216 Cardinal Health VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 55154-4790_ffdd10af-1054-4204-bd4d-c414e9d49f10 55154-4790 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130723 ANDA ANDA077739 Cardinal Health METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 55154-4791_a757af22-6fcb-499c-a77f-007a04382d67 55154-4791 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100323 ANDA ANDA076003 Cardinal Health TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 55154-4792_a4ffb53f-7935-4ddc-844e-0112ae6cb5d4 55154-4792 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20120305 ANDA ANDA075350 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-4793_407420f4-bdef-4d76-bb56-9a55daff6ae7 55154-4793 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20110501 ANDA ANDA078920 Cardinal Health PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 55154-4794_37d1c722-1e8f-48b7-a42b-d8175e990f50 55154-4794 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20130523 ANDA ANDA201294 Cardinal Health MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 55154-4795_8a36a6ef-5893-4da8-ad92-495bc772f247 55154-4795 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20130705 ANDA ANDA090837 Cardinal Health FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 55154-4796_2e1625cd-7337-4eed-95b1-b371c7169b97 55154-4796 HUMAN PRESCRIPTION DRUG Nephrocaps Ascorbic Acid, Folic Acid, Niacin, Thiamine, Riboflavin, Pyridoxine, Cyanocobalamin, Pantothenic Acid, Biotin CAPSULE, LIQUID FILLED ORAL 20100114 UNAPPROVED DRUG OTHER Cardinal Health ASCORBIC ACID; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; PANTOTHENIC ACID 100; 1.5; 1.7; 20; 10; 1; 6; 150; 5 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 55154-4797_7e6789c4-8d34-4da3-8f7b-aead57a0f3b4 55154-4797 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET, FILM COATED ORAL 20110601 ANDA ANDA074256 Cardinal Health GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 55154-4798_275a8e6f-2cbf-46c3-96d7-9204da74b493 55154-4798 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20050922 ANDA ANDA078402 Cardinal Health LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 55154-4799_62b2779c-46f2-4ea2-a1d2-c089333a4066 55154-4799 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20121211 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 55154-4837_8d13e740-73d9-4cbb-b67d-1e1d0d127084 55154-4837 HUMAN PRESCRIPTION DRUG Nifedical XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20001211 ANDA ANDA075289 Cardinal Health NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 55154-4838_7d46690d-090d-4d8b-af63-e57c48fc86b5 55154-4838 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 Cardinal Health SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-4847_4b02b132-8756-47c2-ba83-dc3384e2df82 55154-4847 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20160825 ANDA ANDA075765 Cardinal Health CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 55154-4853_2247e68f-60ba-42fc-b617-2fc2843994a5 55154-4853 HUMAN OTC DRUG Aleve naproxen sodium TABLET ORAL 19940111 NDA NDA020204 Cardinal Health NAPROXEN SODIUM 220 mg/1 E 20171231 55154-4875_f08fa2ee-70fd-4aff-a737-605bcb771f7b 55154-4875 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20040404 NDA NDA021688 Cardinal Health CINACALCET HYDROCHLORIDE 30 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] E 20171231 55154-4876_f08fa2ee-70fd-4aff-a737-605bcb771f7b 55154-4876 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20040404 NDA NDA021688 Cardinal Health CINACALCET HYDROCHLORIDE 60 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] E 20171231 55154-4901_5e4cccd6-1582-4db8-b4cf-c2145c4a3c12 55154-4901 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20110629 ANDA ANDA084612 Cardinal Health DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 55154-4908_3a4d1cf1-caf4-4879-b9be-9ca681c16fc0 55154-4908 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 Cardinal Health FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-4909_3a4d1cf1-caf4-4879-b9be-9ca681c16fc0 55154-4909 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19860124 ANDA ANDA070086 Cardinal Health FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-4914_5e4cccd6-1582-4db8-b4cf-c2145c4a3c12 55154-4914 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20110629 ANDA ANDA087916 Cardinal Health DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 55154-4920_e214ab18-c4e7-4b37-b761-7fb921c82be2 55154-4920 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870728 NDA NDA017812 Cardinal Health LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20191231 55154-4921_a31077bd-4dc4-4f75-b9d1-8b85bda1a463 55154-4921 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 19960216 ANDA ANDA074069 Cardinal Health AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] E 20171231 55154-4926_c3a60ddc-720f-4a42-9deb-3ebb9f9aa820 55154-4926 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087800 Cardinal Health PREDNISONE 1 mg/1 N 20181231 55154-4938_c3a60ddc-720f-4a42-9deb-3ebb9f9aa820 55154-4938 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 Cardinal Health PREDNISONE 5 mg/1 N 20181231 55154-4941_e214ab18-c4e7-4b37-b761-7fb921c82be2 55154-4941 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 19820129 NDA NDA018558 Cardinal Health LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20191231 55154-4945_664beea2-fc7f-4748-801b-9cb398604976 55154-4945 HUMAN PRESCRIPTION DRUG Lidocaine Viscous Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19850426 ANDA ANDA088802 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 55154-4946_c3a60ddc-720f-4a42-9deb-3ebb9f9aa820 55154-4946 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 Cardinal Health PREDNISONE 20 mg/1 N 20181231 55154-4949_c3a60ddc-720f-4a42-9deb-3ebb9f9aa820 55154-4949 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 Cardinal Health PREDNISONE 10 mg/1 N 20181231 55154-4950_c3a60ddc-720f-4a42-9deb-3ebb9f9aa820 55154-4950 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030314 ANDA ANDA084283 Cardinal Health PREDNISONE 50 mg/1 N 20181231 55154-4951_e8aee7a9-1782-4953-b118-b1f65f2f8d14 55154-4951 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole LOZENGE ORAL; TOPICAL 20040729 ANDA ANDA076387 Cardinal Health CLOTRIMAZOLE 10 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 55154-4953_49212741-389f-4112-94a9-d14ea2115825 55154-4953 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 19960216 ANDA ANDA074069 Cardinal Health AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] E 20171231 55154-4956_3ab60e1f-5d94-4126-abf4-6397c70b3556 55154-4956 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Cardinal Health RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-4957_3ab60e1f-5d94-4126-abf4-6397c70b3556 55154-4957 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Cardinal Health RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-4958_4d08b712-8673-445c-b1e0-3d61dc0814fd 55154-4958 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071009 ANDA ANDA077795 Cardinal Health OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 55154-4959_4d08b712-8673-445c-b1e0-3d61dc0814fd 55154-4959 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20071009 ANDA ANDA077795 Cardinal Health OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 55154-4961_f0e86529-0052-4470-9ef4-7af96ea7fc02 55154-4961 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20080226 ANDA ANDA077728 Cardinal Health CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 55154-4975_1444648c-2a2b-464e-9941-b0867a5ce305 55154-4975 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20130612 ANDA ANDA087479 Cardinal Health HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 55154-4976_11de5c61-8685-4f39-aa05-679717b7971e 55154-4976 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20130614 UNAPPROVED DRUG OTHER Cardinal Health LORATADINE 10 mg/1 N 20191231 55154-4979_8ba9359f-e7f0-49e0-8b85-ce1197135d6c 55154-4979 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20130904 ANDA ANDA074112 Cardinal Health ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-4980_829085c0-fbb2-47be-a7e0-70ce97044a55 55154-4980 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131223 ANDA ANDA090694 Cardinal Health DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 55154-4981_829085c0-fbb2-47be-a7e0-70ce97044a55 55154-4981 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131223 ANDA ANDA090694 Cardinal Health DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 55154-4982_a93926b7-be06-4279-9e7a-a028fef44144 55154-4982 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20130524 ANDA ANDA077751 Cardinal Health PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55154-4983_69035322-bd0b-42fb-a00d-b614f5390de3 55154-4983 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130709 ANDA ANDA090548 Cardinal Health ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-4984_e8ca9822-71a4-42b3-b560-875ec2a495d7 55154-4984 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20130726 ANDA ANDA077728 Cardinal Health CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 55154-4985_d93f04d6-b146-4617-b691-f151bd92feb4 55154-4985 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140203 ANDA ANDA077955 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 55154-4986_02be47ad-999f-4565-b9a9-21f447314140 55154-4986 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140217 ANDA ANDA065507 Cardinal Health AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 55154-4987_e3bd0889-b838-4c6f-9934-325f349f8bc3 55154-4987 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140306 ANDA ANDA090617 Cardinal Health METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-4988_6eeb9fe6-57e2-45e6-9e9b-896d2ef16efc 55154-4988 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130626 ANDA ANDA076899 Cardinal Health SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 55154-4989_4f3afd16-1b5e-49ea-88c0-8087c0715294 55154-4989 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20100511 ANDA ANDA076514 Cardinal Health MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20191231 55154-4990_5530904d-7f23-4dac-acf3-028e2794df64 55154-4990 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine Phosphate acetaminophen and codeine phosphate TABLET ORAL 20100113 ANDA ANDA089805 Cardinal Health CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 55154-4991_891913a5-dfae-41d0-92de-2aa852ac714d 55154-4991 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20080703 ANDA ANDA077614 Cardinal Health CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 55154-4992_b0160b4a-d3a7-478c-8a79-d31beb38afa9 55154-4992 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131223 ANDA ANDA077321 Cardinal Health LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-4993_e3bd0889-b838-4c6f-9934-325f349f8bc3 55154-4993 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140306 ANDA ANDA090617 Cardinal Health METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-4994_50e3d937-21eb-497c-8dbd-21c135dfa2a3 55154-4994 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 20130605 ANDA ANDA072579 Cardinal Health NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55154-4995_0f3f62eb-08e4-4ac5-bc17-41ed054d2626 55154-4995 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20131014 ANDA ANDA078558 Cardinal Health IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55154-4996_8b7c4f7c-3ea9-4575-8f76-a6eed93f5dfb 55154-4996 HUMAN PRESCRIPTION DRUG AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET ORAL 20090925 ANDA ANDA079029 Cardinal Health AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 55154-4997_41c455e5-c24d-4fd5-b6b3-024b8ea8af92 55154-4997 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20130930 ANDA ANDA091305 Cardinal Health NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 55154-4998_5420c55f-7dfa-4afe-8b36-b0f7cc691542 55154-4998 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20130716 ANDA ANDA091667 Cardinal Health MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 55154-4999_a93926b7-be06-4279-9e7a-a028fef44144 55154-4999 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20130524 ANDA ANDA077751 Cardinal Health PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55154-5009_8e86920e-1432-4eee-aff4-6736c217a829 55154-5009 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Cardinal Health LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 55154-5016_8e86920e-1432-4eee-aff4-6736c217a829 55154-5016 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Cardinal Health LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 55154-5019_ebcb1bef-463a-4503-b847-68d45d0aced6 55154-5019 HUMAN PRESCRIPTION DRUG PRIMAXIN IV imipenem and cilastatin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19870108 ANDA ANDA062756 Cardinal Health IMIPENEM; CILASTATIN SODIUM 500; 500 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] E 20171231 55154-5026_4dd325bb-58b9-4126-8662-63f680c26bf2 55154-5026 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20100510 NDA NDA019962 Cardinal Health METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-5028_6943beeb-03aa-48c8-8a18-0cee9dc46f28 55154-5028 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 19980220 NDA NDA020829 Cardinal Health MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 55154-5029_6943beeb-03aa-48c8-8a18-0cee9dc46f28 55154-5029 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Cardinal Health MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 55154-5030_ebcb1bef-463a-4503-b847-68d45d0aced6 55154-5030 HUMAN PRESCRIPTION DRUG PRIMAXIN IV imipenem and cilastatin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19851126 NDA NDA050587 Cardinal Health IMIPENEM; CILASTATIN SODIUM 500; 500 mg/100mL; mg/100mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] E 20171231 55154-5031_5d0e4af9-7f9f-4124-895a-8c88192b94d4 55154-5031 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20110729 NDA NDA021445 Cardinal Health EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] E 20171231 55154-5033_d487533f-c1f6-48a9-94fb-48f6fbad7ca4 55154-5033 HUMAN PRESCRIPTION DRUG Mephyton phytonadione TABLET ORAL 19550930 NDA NDA010104 Cardinal Health PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] E 20171231 55154-5034_4f993928-78ad-4797-a273-755d3819b090 55154-5034 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20090727 NDA NDA021445 Cardinal Health EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] E 20171231 55154-5035_d4754e75-955f-4d5f-8263-fc45e6629819 55154-5035 HUMAN OTC DRUG MiraLAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20090223 NDA NDA022015 Cardinal Health POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 55154-5040_81aa2b05-bd99-45a9-9781-2666c80f4889 55154-5040 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Cardinal Health SITAGLIPTIN PHOSPHATE 50 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 55154-5041_81aa2b05-bd99-45a9-9781-2666c80f4889 55154-5041 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Cardinal Health SITAGLIPTIN PHOSPHATE 100 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 55154-5042_6ecf67a3-6237-449a-b4fa-e33861e4d27b 55154-5042 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Cardinal Health SITAGLIPTIN PHOSPHATE 100 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 55154-5043_d3f0f926-6014-45ab-9cad-54b22c6ff4dc 55154-5043 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20021025 NDA NDA021445 Cardinal Health EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] E 20171231 55154-5044_98eac2c1-5857-4aa5-a534-497345d81bf9 55154-5044 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20061016 NDA NDA021995 Cardinal Health SITAGLIPTIN PHOSPHATE 50 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 55154-5051_8ff5a2cc-9cdf-4526-aa40-741a20488d74 55154-5051 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20120827 ANDA ANDA076071 Cardinal Health LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-5052_8ff5a2cc-9cdf-4526-aa40-741a20488d74 55154-5052 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20120827 ANDA ANDA076071 Cardinal Health LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-5053_8ff5a2cc-9cdf-4526-aa40-741a20488d74 55154-5053 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20120827 ANDA ANDA076071 Cardinal Health LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-5055_83a9d114-2832-4ab0-9584-2a900e32d21c 55154-5055 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20110204 ANDA ANDA040424 Cardinal Health SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20191231 55154-5056_7ca646e7-3aad-46e7-9de8-93a38e65ae98 55154-5056 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110620 ANDA ANDA073457 Cardinal Health ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-5057_e5b78cf7-675c-49fc-8f1b-1e9c6c01ea36 55154-5057 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20100114 ANDA ANDA076110 Cardinal Health TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 55154-5059_9ca3ea2e-5de6-48fe-8889-12878bc9e510 55154-5059 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20040215 ANDA ANDA070278 Cardinal Health HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20191231 55154-5062_612a5628-d2d3-48bf-820c-1e80c5a7fd62 55154-5062 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130404 ANDA ANDA076052 Cardinal Health SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-5063_612a5628-d2d3-48bf-820c-1e80c5a7fd62 55154-5063 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130404 ANDA ANDA076052 Cardinal Health SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-5065_83a9d114-2832-4ab0-9584-2a900e32d21c 55154-5065 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20110204 ANDA ANDA040424 Cardinal Health SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20191231 55154-5066_bab3693b-d653-43eb-a497-713eb08973e2 55154-5066 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 20110617 ANDA ANDA086009 Cardinal Health AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55154-5067_bed243c3-9497-45af-9fd7-2cafc25ccc96 55154-5067 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110818 ANDA ANDA071017 Cardinal Health SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 55154-5068_dec6f686-26be-44ef-9c1c-d38ca6ba648c 55154-5068 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20110128 ANDA ANDA076354 Cardinal Health TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55154-5070_a1b05b71-7c89-4f2a-ab87-5f0e3b869489 55154-5070 HUMAN PRESCRIPTION DRUG Glimepiride glimepiride TABLET ORAL 20101104 ANDA ANDA077624 Cardinal Health GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55154-5071_b0cafa5c-8643-414d-a14b-e8b369ae8033 55154-5071 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20100806 ANDA ANDA075189 Cardinal Health NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 55154-5072_2359e42c-9e29-42f5-81d9-3ecea3b5c45c 55154-5072 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100114 ANDA ANDA076418 Cardinal Health AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55154-5073_1b67797e-c04a-483f-ad72-7fc15e3abbfa 55154-5073 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20110920 ANDA ANDA070213 Cardinal Health PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-5074_a968a553-c903-4866-a63a-6e063f96efca 55154-5074 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20091120 ANDA ANDA070325 Cardinal Health DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55154-5079_ee68d2b8-b8d5-44c2-898c-fa8f5af9e310 55154-5079 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20110128 ANDA ANDA076578 Cardinal Health ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 55154-5080_ee68d2b8-b8d5-44c2-898c-fa8f5af9e310 55154-5080 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20110128 ANDA ANDA076578 Cardinal Health ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 55154-5082_8ff5a2cc-9cdf-4526-aa40-741a20488d74 55154-5082 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20120827 ANDA ANDA076071 Cardinal Health LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-5085_bf91b396-31ca-436a-9074-bceb9aaca13b 55154-5085 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20110513 ANDA ANDA088468 Cardinal Health HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 55154-5087_1e6d7ef5-21f1-41bb-ae14-19333ea42314 55154-5087 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20110114 ANDA ANDA078902 Cardinal Health PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-5088_57c788c6-9e2d-467a-b69b-2315b2623dfe 55154-5088 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20110401 ANDA ANDA084768 Cardinal Health CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-5089_57c788c6-9e2d-467a-b69b-2315b2623dfe 55154-5089 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20110401 ANDA ANDA083116 Cardinal Health CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-5090_dc848931-c78a-43b7-8349-00fab921caa0 55154-5090 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20110204 ANDA ANDA070920 Cardinal Health TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55154-5091_3a3afdf7-59dd-45e8-8f3c-b0001eff37b7 55154-5091 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110711 ANDA ANDA075124 Cardinal Health DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 55154-5092_85b57b2c-02b0-4525-a9f8-d8241e29f32b 55154-5092 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20110803 ANDA ANDA088487 Cardinal Health HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 55154-5093_2a911dc9-a0fa-4efa-8d09-b300038cce28 55154-5093 HUMAN PRESCRIPTION DRUG Methyldopa methyldopa TABLET ORAL 20110823 ANDA ANDA070076 Cardinal Health METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 55154-5094_d2b0eaab-ff25-4839-8644-d8fa3b711457 55154-5094 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20110128 ANDA ANDA040185 Cardinal Health PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 55154-5095_562ed0bc-02f3-44ea-a8a1-ca127ebbf188 55154-5095 HUMAN PRESCRIPTION DRUG PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET, FILM COATED ORAL 20110520 ANDA ANDA075998 Cardinal Health PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] E 20171231 55154-5097_2359e42c-9e29-42f5-81d9-3ecea3b5c45c 55154-5097 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100114 ANDA ANDA076418 Cardinal Health AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55154-5099_2d44179c-2f4f-4f84-aeb7-3521f6b2c7cc 55154-5099 HUMAN OTC DRUG Loratadine loratadine TABLET ORAL 20091119 ANDA ANDA075790 Cardinal Health LORATADINE 10 mg/1 E 20171231 55154-5102_c39229c7-e55e-48b8-901b-cd8d793c14ad 55154-5102 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20110628 ANDA ANDA080817 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 55154-5106_4e9b4294-9a44-47a7-b113-f2e271c19c4d 55154-5106 HUMAN PRESCRIPTION DRUG Digoxin Digoxin INJECTION INTRAMUSCULAR; INTRAVENOUS 20110628 ANDA ANDA083391 Cardinal Health DIGOXIN .25 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20191231 55154-5112_30bb19f8-f3ac-40b4-ad37-106de939d1a0 55154-5112 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083312 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 55154-5117_f7d8ef47-ddbf-4d44-b331-a46170b77b2f 55154-5117 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19750716 ANDA ANDA084307 Cardinal Health PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20191231 55154-5118_5c7c401c-b97e-44bd-9304-7a9aee1ec3c6 55154-5118 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION INTRAMUSCULAR; INTRAVENOUS 19820907 ANDA ANDA087702 Cardinal Health DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 55154-5127_8ab8b554-d2a3-43f7-8885-6bf6dd2c2a0c 55154-5127 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100126 ANDA ANDA083312 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 55154-5129_18deff91-7460-47f1-a94a-e600aa243f34 55154-5129 HUMAN PRESCRIPTION DRUG Phenylephrine Hydrochloride Phenylephrine Hydrochloride INJECTION INTRAVENOUS 20121218 NDA NDA203826 Cardinal Health PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] E 20171231 55154-5154_7ca8988e-3f57-4a73-8b72-f339d1246669 55154-5154 HUMAN PRESCRIPTION DRUG Dexilant dexlansoprazole CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022287 Cardinal Health DEXLANSOPRAZOLE 60 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55154-5157_8c06e092-721e-45ad-b85b-4191d1a4d7da 55154-5157 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20090901 NDA NDA022352 Cardinal Health COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] E 20171231 55154-5158_c61533e1-6f0a-45b2-84ff-f6ecd8c07ebc 55154-5158 HUMAN PRESCRIPTION DRUG ULORIC febuxostat TABLET ORAL 20090213 NDA NDA021856 Cardinal Health FEBUXOSTAT 40 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20191231 55154-5159_c61533e1-6f0a-45b2-84ff-f6ecd8c07ebc 55154-5159 HUMAN PRESCRIPTION DRUG ULORIC febuxostat TABLET ORAL 20090213 NDA NDA021856 Cardinal Health FEBUXOSTAT 80 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20191231 55154-5175_68c720a8-0230-4e0d-8c37-d0e8b45bae8b 55154-5175 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE SOLUTION INTRAVENOUS 19830929 NDA NDA018900 Cardinal Health METRONIDAZOLE 500 mg/100mL Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 55154-5224_880b4ba8-26ac-4046-8425-3e23be43b593 55154-5224 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20101104 ANDA ANDA074226 Cardinal Health GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55154-5275_b08acae1-32a7-43a2-bc79-4777b8cb4fd2 55154-5275 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090721 ANDA ANDA079001 Cardinal Health VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] E 20171231 55154-5325_d35ea948-20e1-4d32-a246-e16162b11326 55154-5325 HUMAN PRESCRIPTION DRUG Ofirmev acetaminophen INJECTION, SOLUTION INTRAVENOUS 20101108 NDA NDA022450 Cardinal Health ACETAMINOPHEN 10 mg/mL N 20181231 55154-5351_727cad56-e4a2-48ec-83a7-15b7722f6dcf 55154-5351 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20110520 ANDA ANDA064150 Cardinal Health RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 55154-5352_82f1724d-ccf2-4034-96c7-1497320ff180 55154-5352 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 325 mg/1 E 20171231 55154-5353_bab3693b-d653-43eb-a497-713eb08973e2 55154-5353 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 20110617 ANDA ANDA086009 Cardinal Health AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55154-5355_86dc64f8-4273-4518-b584-d6a6033cd2b0 55154-5355 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20091130 ANDA ANDA076122 Cardinal Health MIRTAZAPINE 15 mg/1 N 20181231 55154-5356_970e76bd-1369-461e-ac06-df2be10116ff 55154-5356 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110114 ANDA ANDA076704 Cardinal Health METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-5357_4b05e996-c8c3-4d78-9e51-38e1056c0d24 55154-5357 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070620 ANDA ANDA019684 Cardinal Health NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 55154-5358_4b05e996-c8c3-4d78-9e51-38e1056c0d24 55154-5358 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071106 ANDA ANDA019684 Cardinal Health NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 55154-5359_9f6e2387-d325-4146-8a9d-58152ec61c40 55154-5359 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100507 ANDA ANDA090408 Cardinal Health TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55154-5360_bf85a378-6a09-4b35-b145-0624b1864241 55154-5360 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20091105 ANDA ANDA090324 Cardinal Health CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 55154-5361_dc5c6650-7ee8-4357-b037-08cd265b985a 55154-5361 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA073229 Cardinal Health VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55154-5362_a6f1ed80-4b88-44f2-819a-9fb6293e5eff 55154-5362 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20101029 ANDA ANDA076187 Cardinal Health LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55154-5363_6627686c-eb8f-4aeb-854f-36dc73481699 55154-5363 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100623 ANDA ANDA090649 Cardinal Health NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55154-5364_b7e5f316-45af-48d5-b722-f2182459bf6b 55154-5364 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20101008 ANDA ANDA040245 Cardinal Health CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 55154-5365_da72b3fc-3754-4ac7-930b-633e785486c2 55154-5365 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20120210 ANDA ANDA076056 Cardinal Health PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55154-5366_1a5ed33b-03fa-4b20-87c3-c4d52a7604a5 55154-5366 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride pramipexole dihydrochloride TABLET ORAL 20101117 ANDA ANDA077854 Cardinal Health PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 55154-5367_8574acd5-ad13-424f-bdfe-152c6623b24c 55154-5367 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20110812 ANDA ANDA091590 Cardinal Health LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 55154-5368_6627686c-eb8f-4aeb-854f-36dc73481699 55154-5368 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100623 ANDA ANDA090649 Cardinal Health NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55154-5369_8f5ff9cb-9ab1-4a05-939b-b4296b27f7e2 55154-5369 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron TABLET, FILM COATED ORAL 20121205 ANDA ANDA076930 Cardinal Health ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55154-5370_da72b3fc-3754-4ac7-930b-633e785486c2 55154-5370 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20120210 ANDA ANDA076056 Cardinal Health PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55154-5371_68e043a5-e7de-4013-85ba-a2fa7bce624f 55154-5371 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20120105 ANDA ANDA076314 Cardinal Health TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 55154-5372_68e043a5-e7de-4013-85ba-a2fa7bce624f 55154-5372 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET, FILM COATED ORAL 20120105 ANDA ANDA076314 Cardinal Health TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 55154-5373_fa6d08ab-8992-4fe9-bb83-0455662c793f 55154-5373 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111003 ANDA ANDA090868 Cardinal Health SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-5374_fa6d08ab-8992-4fe9-bb83-0455662c793f 55154-5374 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111003 ANDA ANDA090868 Cardinal Health SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-5375_4615cebc-cfda-462a-b130-7f2154e65119 55154-5375 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20110520 ANDA ANDA040756 Cardinal Health FOLIC ACID 1 mg/1 N 20181231 55154-5376_15559c6d-c9c0-4f26-a6f9-440dbe7e3419 55154-5376 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20120629 ANDA ANDA075817 Cardinal Health CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55154-5377_3d7e45c8-ca2a-4e42-aef6-4c367ddd76ae 55154-5377 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100723 ANDA ANDA091176 Cardinal Health HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 55154-5378_fa6d08ab-8992-4fe9-bb83-0455662c793f 55154-5378 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111003 ANDA ANDA090868 Cardinal Health SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-5379_2e98b568-0832-4a33-8712-deae7932b9de 55154-5379 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Cardinal Health ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-5380_a6f1ed80-4b88-44f2-819a-9fb6293e5eff 55154-5380 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20101029 ANDA ANDA076187 Cardinal Health LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55154-5381_a6f1ed80-4b88-44f2-819a-9fb6293e5eff 55154-5381 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20101029 ANDA ANDA076187 Cardinal Health LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55154-5382_c46a0b74-e2c1-4436-9d16-d0119407ba94 55154-5382 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil TABLET, FILM COATED ORAL 20111025 ANDA ANDA065521 Cardinal Health MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 55154-5383_516850ee-062a-424a-89e9-da8fde29d2e2 55154-5383 HUMAN OTC DRUG Polyethylene Glycol (3350) polyethylene glycol (3350) POWDER, FOR SOLUTION ORAL 20091120 ANDA ANDA078915 Cardinal Health POLYETHYLENE GLYCOL 3500 17 g/17g N 20191231 55154-5384_bea3b4cc-2200-446b-9061-80e514f2dc4f 55154-5384 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120925 ANDA ANDA078518 Cardinal Health VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 55154-5385_d53c86a2-99ca-4e40-b61b-d3cce1ce0f7e 55154-5385 HUMAN PRESCRIPTION DRUG Voriconazole voriconazole TABLET, FILM COATED ORAL 20120921 ANDA ANDA090547 Cardinal Health VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 55154-5386_2e98b568-0832-4a33-8712-deae7932b9de 55154-5386 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Cardinal Health ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-5387_56020a75-edff-4096-84b3-35c0c900c2a0 55154-5387 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20120824 ANDA ANDA077420 Cardinal Health LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55154-5388_4113abcf-8710-49ba-a7ae-51234a35e6e5 55154-5388 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate clopidogrel TABLET, FILM COATED ORAL 20120608 ANDA ANDA077665 Cardinal Health CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 55154-5389_15e34372-d10b-4da3-860c-ca3430ac4c4f 55154-5389 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20110818 ANDA ANDA070791 Cardinal Health DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 55154-5390_83540d64-81ba-441b-922b-cf18cc12b13b 55154-5390 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20110513 ANDA ANDA074621 Cardinal Health MEGESTROL ACETATE 20 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 55154-5391_837e0a74-1ddc-4c3d-866e-73caeec41c41 55154-5391 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20121011 ANDA ANDA070035 Cardinal Health METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 55154-5392_837e0a74-1ddc-4c3d-866e-73caeec41c41 55154-5392 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20121011 ANDA ANDA070044 Cardinal Health METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 55154-5393_dd3554ed-749b-4736-ab77-77966eb5c9f0 55154-5393 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120919 ANDA ANDA072688 Cardinal Health RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-5394_bf91b396-31ca-436a-9074-bceb9aaca13b 55154-5394 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20110513 ANDA ANDA089097 Cardinal Health HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 55154-5395_a6f1ed80-4b88-44f2-819a-9fb6293e5eff 55154-5395 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20101029 ANDA ANDA076187 Cardinal Health LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55154-5396_56020a75-edff-4096-84b3-35c0c900c2a0 55154-5396 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET ORAL 20120824 ANDA ANDA077420 Cardinal Health LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55154-5397_a7a5b420-eab0-4bff-a766-55860cdce7e7 55154-5397 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20100331 ANDA ANDA075272 Cardinal Health BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 55154-5398_6912788d-9c81-4ce3-9da3-5175219d9e78 55154-5398 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20110107 ANDA ANDA077923 Cardinal Health MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 55154-5399_60d70127-34b2-4fe8-86e9-78b38e4eb3c6 55154-5399 HUMAN OTC DRUG Cetirizine Hydrochloride cetirizine hydrochloride TABLET, FILM COATED ORAL 20120330 ANDA ANDA076677 Cardinal Health CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55154-5406_05a9158b-c07a-4a4e-8d22-88a37ce32de7 55154-5406 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880107 ANDA ANDA086223 Cardinal Health ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 55154-5407_05a9158b-c07a-4a4e-8d22-88a37ce32de7 55154-5407 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19880407 ANDA ANDA089367 Cardinal Health ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 55154-5412_c27243df-35f8-4047-a6b3-0589f1d45348 55154-5412 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071206 Cardinal Health HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] E 20171231 55154-5413_c27243df-35f8-4047-a6b3-0589f1d45348 55154-5413 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071207 Cardinal Health HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] E 20171231 55154-5414_c27243df-35f8-4047-a6b3-0589f1d45348 55154-5414 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071209 Cardinal Health HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] E 20171231 55154-5420_b5743b2b-9964-4489-a569-81061140357c 55154-5420 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Cardinal Health AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 55154-5423_5436faa2-a6d8-4a24-ba3d-7614867d697d 55154-5423 HUMAN PRESCRIPTION DRUG Promethazine HCl Promethazine HCl TABLET ORAL 20110621 ANDA ANDA084234 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 55154-5429_c27243df-35f8-4047-a6b3-0589f1d45348 55154-5429 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071208 Cardinal Health HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] E 20171231 55154-5430_93983865-362f-40a8-ba41-a8bcb99e35cb 55154-5430 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20090810 ANDA ANDA065461 Cardinal Health TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] E 20171231 55154-5431_e77e76b1-cf20-4132-9fda-7de5ae84cc0c 55154-5431 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA078050 Cardinal Health ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55154-5432_3739729d-a52e-4226-a2f0-ee0e5ee6a401 55154-5432 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 19881209 ANDA ANDA062831 Cardinal Health CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55154-5433_f619ba6a-9e6a-4987-a2fb-9d0794b2f8c1 55154-5433 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 55154-5434_f619ba6a-9e6a-4987-a2fb-9d0794b2f8c1 55154-5434 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 55154-5435_f619ba6a-9e6a-4987-a2fb-9d0794b2f8c1 55154-5435 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 55154-5436_f619ba6a-9e6a-4987-a2fb-9d0794b2f8c1 55154-5436 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 55154-5437_f619ba6a-9e6a-4987-a2fb-9d0794b2f8c1 55154-5437 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] E 20171231 55154-5438_1522ce5c-b874-4009-8442-3beedb9cd1a5 55154-5438 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20090810 ANDA ANDA065461 Cardinal Health TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20191231 55154-5439_27eb4eae-9e38-4dbd-ad2e-4750efd57db0 55154-5439 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; PARENTERAL 19881209 ANDA ANDA062831 Cardinal Health CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 55154-5440_ea4ce850-fe0b-43da-b0fd-9a339d153237 55154-5440 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-5441_ea4ce850-fe0b-43da-b0fd-9a339d153237 55154-5441 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-5442_ea4ce850-fe0b-43da-b0fd-9a339d153237 55154-5442 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-5443_ea4ce850-fe0b-43da-b0fd-9a339d153237 55154-5443 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-5444_ea4ce850-fe0b-43da-b0fd-9a339d153237 55154-5444 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20100723 ANDA ANDA077857 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-5445_87688f92-a620-437d-904a-25c19d4270c8 55154-5445 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20030226 ANDA ANDA076400 Cardinal Health PROPRANOLOL HYDROCHLORIDE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-5446_a76602b6-9420-452e-9bee-5b68c0ec275c 55154-5446 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 Cardinal Health CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 55154-5451_8cfb7c53-56a0-4ab2-8580-a7386f96f348 55154-5451 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20091231 ANDA ANDA074215 Cardinal Health ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-5452_aaeddd73-77b2-4499-8456-d39b305b9823 55154-5452 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20091231 ANDA ANDA075150 Cardinal Health CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-5454_08097b3c-d70f-438e-8f98-d2bcc2dab3b2 55154-5454 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20110520 ANDA ANDA018659 Cardinal Health ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 55154-5455_7ca646e7-3aad-46e7-9de8-93a38e65ae98 55154-5455 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110620 ANDA ANDA073456 Cardinal Health ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-5461_e7d1eb47-8e82-4d07-b7b3-e7c33509aab8 55154-5461 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20110527 ANDA ANDA070848 Cardinal Health SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] E 20171231 55154-5462_aaeddd73-77b2-4499-8456-d39b305b9823 55154-5462 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20091231 ANDA ANDA075150 Cardinal Health CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-5463_605b8991-7238-41ad-8a86-8e09730a6678 55154-5463 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20101013 ANDA ANDA075480 Cardinal Health ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55154-5464_c129ba90-c4a8-457d-aa72-622a4050fcb7 55154-5464 HUMAN PRESCRIPTION DRUG Famotidine famotidine TABLET, FILM COATED ORAL 20101013 ANDA ANDA075704 Cardinal Health FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55154-5465_e0a1ff93-0417-411d-abc6-c4b4753c169f 55154-5465 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20110429 ANDA ANDA074434 Cardinal Health CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 55154-5468_592e23dc-11b7-467a-bdd1-a3bc0899aef9 55154-5468 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin TABLET ORAL 20110818 ANDA ANDA075509 Cardinal Health DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55154-5469_592e23dc-11b7-467a-bdd1-a3bc0899aef9 55154-5469 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin TABLET ORAL 20110818 ANDA ANDA075509 Cardinal Health DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55154-5470_2a6dd1bd-3ec1-4541-ad89-74ff5a06d83f 55154-5470 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous Terazosin Hydrochloride Anhydrous CAPSULE ORAL 20110128 ANDA ANDA075140 Cardinal Health TERAZOSIN HYDROCHLORIDE ANHYDROUS 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 55154-5471_2a6dd1bd-3ec1-4541-ad89-74ff5a06d83f 55154-5471 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Anhydrous Terazosin Hydrochloride Anhydrous CAPSULE ORAL 20110128 ANDA ANDA075140 Cardinal Health TERAZOSIN HYDROCHLORIDE ANHYDROUS 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 55154-5472_1fafb889-1b0b-431b-8048-25484fc54624 55154-5472 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000701 ANDA ANDA075491 Cardinal Health BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 55154-5473_e0a1ff93-0417-411d-abc6-c4b4753c169f 55154-5473 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20110429 ANDA ANDA074434 Cardinal Health CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 55154-5474_8180ffc0-e1e3-4947-a553-2368cf97a587 55154-5474 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM 250 mg/1 E 20171231 55154-5475_605b8991-7238-41ad-8a86-8e09730a6678 55154-5475 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20101013 ANDA ANDA075480 Cardinal Health ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55154-5476_139b7c19-349f-41a7-97e7-468b6fec70af 55154-5476 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20110513 ANDA ANDA074388 Cardinal Health GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55154-5477_c3213087-bdc3-4cad-b957-1907d9609c92 55154-5477 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20101012 ANDA ANDA070082 Cardinal Health FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-5478_970e76bd-1369-461e-ac06-df2be10116ff 55154-5478 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110114 ANDA ANDA076704 Cardinal Health METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-5481_4b442858-3e0f-46df-8819-c7d2703d7729 55154-5481 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19921105 ANDA ANDA072837 Cardinal Health DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 55154-5482_f3b2f090-5704-4d63-a403-e1289058bffc 55154-5482 HUMAN OTC DRUG Diphenhydramine HCl Diphenhydramine HCl TABLET ORAL 20110603 UNAPPROVED DRUG OTHER Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 55154-5483_af8bf978-45e7-4548-a314-beb205f36749 55154-5483 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100723 ANDA ANDA074425 Cardinal Health PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] E 20171231 55154-5485_e37868f2-281a-4f9e-a640-4255ed0f8864 55154-5485 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20110506 ANDA ANDA075113 Cardinal Health LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-5487_bfab8455-8937-4ac9-a71a-960bbb298beb 55154-5487 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20090915 ANDA ANDA075976 Cardinal Health METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 55154-5488_c80bbd11-c231-4110-871a-a1a1313010bf 55154-5488 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120712 ANDA ANDA074587 Cardinal Health VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 55154-5491_e37868f2-281a-4f9e-a640-4255ed0f8864 55154-5491 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20110506 ANDA ANDA075113 Cardinal Health LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-5492_347f81a6-aaeb-4457-bec9-1dbfd28e7115 55154-5492 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 19981130 ANDA ANDA074739 Cardinal Health AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 55154-5494_a7a5b420-eab0-4bff-a766-55860cdce7e7 55154-5494 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20100331 ANDA ANDA075272 Cardinal Health BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 55154-5495_a7dc3e65-a424-45c4-aeff-01b4c5f24a8c 55154-5495 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine hydrochloride CAPSULE ORAL 20110711 ANDA ANDA075207 Cardinal Health FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-5496_5ce78352-aaa9-4964-9678-618e7a40a65e 55154-5496 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20110128 ANDA ANDA040298 Cardinal Health PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 55154-5499_8cfb7c53-56a0-4ab2-8580-a7386f96f348 55154-5499 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20091231 ANDA ANDA074215 Cardinal Health ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-5504_4b442858-3e0f-46df-8819-c7d2703d7729 55154-5504 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19921105 ANDA ANDA073185 Cardinal Health DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 55154-5509_5476b43b-b796-45f4-bb3f-e931b027e5b7 55154-5509 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20111006 ANDA ANDA070035 Cardinal Health METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 55154-5510_5083f760-7064-47b2-b93c-ccf005bb34b1 55154-5510 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20110823 ANDA ANDA070184 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 55154-5511_7ca646e7-3aad-46e7-9de8-93a38e65ae98 55154-5511 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110620 ANDA ANDA073457 Cardinal Health ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-5512_970e76bd-1369-461e-ac06-df2be10116ff 55154-5512 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20110114 ANDA ANDA076704 Cardinal Health METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-5516_83540d64-81ba-441b-922b-cf18cc12b13b 55154-5516 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20110513 ANDA ANDA074621 Cardinal Health MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 55154-5517_83a9d114-2832-4ab0-9584-2a900e32d21c 55154-5517 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20110204 ANDA ANDA040424 Cardinal Health SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20191231 55154-5523_4b442858-3e0f-46df-8819-c7d2703d7729 55154-5523 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19921105 ANDA ANDA073186 Cardinal Health DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 55154-5526_5083f760-7064-47b2-b93c-ccf005bb34b1 55154-5526 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20110823 ANDA ANDA072801 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 55154-5530_5f35a106-3eb9-4adf-b37c-b6871bb7dd93 55154-5530 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20110120 ANDA ANDA080738 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 55154-5534_08097b3c-d70f-438e-8f98-d2bcc2dab3b2 55154-5534 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20110520 ANDA ANDA018659 Cardinal Health ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 55154-5537_5d043b8d-600c-42c8-98ef-09b281d9bc44 55154-5537 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20110520 ANDA ANDA074625 Cardinal Health OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 55154-5539_c3213087-bdc3-4cad-b957-1907d9609c92 55154-5539 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20101012 NDA NDA018487 Cardinal Health FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-5540_c3213087-bdc3-4cad-b957-1907d9609c92 55154-5540 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20101012 NDA NDA018487 Cardinal Health FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-5546_adee7008-624e-4911-847e-202ccaa5b0ac 55154-5546 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19890920 ANDA ANDA063029 Cardinal Health CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 55154-5548_ba6ec9f1-18a5-43d6-840e-cfaa5e233c54 55154-5548 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20110114 ANDA ANDA088628 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII E 20171231 55154-5550_e36fe48d-8aaa-40f7-960a-f84410bf69f2 55154-5550 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20101217 ANDA ANDA077657 Cardinal Health LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-5552_2f38c991-ad2c-4c78-907a-dd6bcb4fde15 55154-5552 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 500 mg/1 E 20171231 55154-5553_8cfb7c53-56a0-4ab2-8580-a7386f96f348 55154-5553 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20091231 ANDA ANDA074215 Cardinal Health ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-5554_a968a553-c903-4866-a63a-6e063f96efca 55154-5554 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20091120 ANDA ANDA070325 Cardinal Health DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55154-5561_35a97377-3e30-4eac-a5fc-ac04dc0d18f4 55154-5561 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20110708 ANDA ANDA070317 Cardinal Health CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55154-5562_35a97377-3e30-4eac-a5fc-ac04dc0d18f4 55154-5562 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20110708 ANDA ANDA070317 Cardinal Health CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55154-5564_85b57b2c-02b0-4525-a9f8-d8241e29f32b 55154-5564 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20120925 ANDA ANDA088496 Cardinal Health HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 55154-5567_5476b43b-b796-45f4-bb3f-e931b027e5b7 55154-5567 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20111006 ANDA ANDA070044 Cardinal Health METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 55154-5570_35a97377-3e30-4eac-a5fc-ac04dc0d18f4 55154-5570 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20110708 ANDA ANDA070317 Cardinal Health CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55154-5571_38a27d5a-7544-487e-8b68-8127d095ee3a 55154-5571 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20110715 ANDA ANDA073144 Cardinal Health CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55154-5581_c3b5e40a-d1a8-4929-ac6c-c06111559754 55154-5581 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20110520 ANDA ANDA074467 Cardinal Health RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 55154-5585_49b3bd4b-98bb-438f-a5b2-18e7b4e885f5 55154-5585 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20110727 ANDA ANDA072741 Cardinal Health LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 55154-5588_880b4ba8-26ac-4046-8425-3e23be43b593 55154-5588 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20101104 ANDA ANDA074226 Cardinal Health GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55154-5590_e36fe48d-8aaa-40f7-960a-f84410bf69f2 55154-5590 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20101217 ANDA ANDA077657 Cardinal Health LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-5591_dc848931-c78a-43b7-8349-00fab921caa0 55154-5591 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20110204 ANDA ANDA070920 Cardinal Health TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55154-5599_7a6fd425-d4ce-4569-96cb-db6a985af430 55154-5599 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20110816 ANDA ANDA040319 Cardinal Health DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 55154-5605_371ef590-b063-43ae-9532-135194cf13dc 55154-5605 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride POWDER, FOR SOLUTION ORAL 20091101 UNAPPROVED DRUG OTHER Cardinal Health POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 55154-5606_994228aa-3fa4-4c59-a018-8c37f58caa14 55154-5606 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20110119 ANDA ANDA075135 Cardinal Health AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 55154-5616_650f9b17-e485-41b8-a50f-e6c115706f5e 55154-5616 HUMAN PRESCRIPTION DRUG Sorine Sotalol Hydrochloride TABLET ORAL 20110215 ANDA ANDA075500 Cardinal Health SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20191231 55154-5618_c36f8148-65c6-4008-9e9d-547d3e43daa7 55154-5618 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Cardinal Health WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 55154-5619_c36f8148-65c6-4008-9e9d-547d3e43daa7 55154-5619 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Cardinal Health WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 55154-5620_c36f8148-65c6-4008-9e9d-547d3e43daa7 55154-5620 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Cardinal Health WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 55154-5621_c36f8148-65c6-4008-9e9d-547d3e43daa7 55154-5621 HUMAN PRESCRIPTION DRUG Jantoven Warfarin Sodium TABLET ORAL 20100223 ANDA ANDA040416 Cardinal Health WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 55154-5623_94f5d23d-12c7-447c-bb4f-5447a2a7c380 55154-5623 HUMAN PRESCRIPTION DRUG Midodrine HCl midodrine hydrochloride TABLET ORAL 20041103 ANDA ANDA076725 Cardinal Health MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 55154-5625_7d0af648-051a-4f28-861b-428ceaa6bb8d 55154-5625 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078182 Cardinal Health DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55154-5627_7d0af648-051a-4f28-861b-428ceaa6bb8d 55154-5627 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078182 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55154-5652_57c788c6-9e2d-467a-b69b-2315b2623dfe 55154-5652 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20110401 ANDA ANDA084769 Cardinal Health CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-5653_a968a553-c903-4866-a63a-6e063f96efca 55154-5653 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20091120 ANDA ANDA070325 Cardinal Health DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55154-5655_e36fe48d-8aaa-40f7-960a-f84410bf69f2 55154-5655 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20101217 ANDA ANDA077657 Cardinal Health LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-5656_70996527-aba9-4ea3-b58c-32013833e49c 55154-5656 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20110204 ANDA ANDA075986 Cardinal Health TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 55154-5657_1fb34ad4-df1c-459b-867d-18d1d338fd75 55154-5657 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110401 ANDA ANDA084112 Cardinal Health CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 55154-5659_592e23dc-11b7-467a-bdd1-a3bc0899aef9 55154-5659 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin TABLET ORAL 20110818 ANDA ANDA075509 Cardinal Health DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55154-5660_d2b0eaab-ff25-4839-8644-d8fa3b711457 55154-5660 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20110128 ANDA ANDA040185 Cardinal Health PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 55154-5661_f3f800e2-4bf8-40ba-9c04-bc4d43bdab3f 55154-5661 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-release diltiazem hydrochloride CAPSULE ORAL 20110816 ANDA ANDA074910 Cardinal Health DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 55154-5665_bab3693b-d653-43eb-a497-713eb08973e2 55154-5665 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 20110617 ANDA ANDA086009 Cardinal Health AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55154-5666_708b7ad7-15c2-4736-a3bf-427d586f55df 55154-5666 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20110818 ANDA ANDA075451 Cardinal Health LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-5667_e5b78cf7-675c-49fc-8f1b-1e9c6c01ea36 55154-5667 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20100114 ANDA ANDA076110 Cardinal Health TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 55154-5671_1b67797e-c04a-483f-ad72-7fc15e3abbfa 55154-5671 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20110920 ANDA ANDA070213 Cardinal Health PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-5672_f0739d0d-0e04-4b4b-9fd7-6c5b9152bf63 55154-5672 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040521 ANDA ANDA076430 Cardinal Health BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55154-5673_f0739d0d-0e04-4b4b-9fd7-6c5b9152bf63 55154-5673 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040521 ANDA ANDA076430 Cardinal Health BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55154-5675_2728be30-32fc-4db9-8afe-cec85f5fccbe 55154-5675 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20110218 ANDA ANDA077316 Cardinal Health CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 55154-5676_2728be30-32fc-4db9-8afe-cec85f5fccbe 55154-5676 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20110218 ANDA ANDA077316 Cardinal Health CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 55154-5677_2728be30-32fc-4db9-8afe-cec85f5fccbe 55154-5677 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20110218 ANDA ANDA077316 Cardinal Health CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 55154-5678_2728be30-32fc-4db9-8afe-cec85f5fccbe 55154-5678 HUMAN PRESCRIPTION DRUG Carvedilol carvedilol TABLET, FILM COATED ORAL 20110218 ANDA ANDA077316 Cardinal Health CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 55154-5680_86dc64f8-4273-4518-b584-d6a6033cd2b0 55154-5680 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20091130 ANDA ANDA076122 Cardinal Health MIRTAZAPINE 30 mg/1 N 20181231 55154-5681_0344a768-6208-41df-b023-bc61acf1be2f 55154-5681 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20110114 ANDA ANDA075876 Cardinal Health OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55154-5682_1b67797e-c04a-483f-ad72-7fc15e3abbfa 55154-5682 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20110920 ANDA ANDA070213 Cardinal Health PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-5683_d4ca7c46-e274-492e-85de-4022373a2eb6 55154-5683 HUMAN PRESCRIPTION DRUG Valproic Acid valproic acid CAPSULE ORAL 20120810 ANDA ANDA073229 Cardinal Health VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55154-5684_7a6fd425-d4ce-4569-96cb-db6a985af430 55154-5684 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20110816 ANDA ANDA040317 Cardinal Health DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 55154-5685_3d4ada43-f753-4c23-8969-bd61edcaf397 55154-5685 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20110708 ANDA ANDA077578 Cardinal Health FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 55154-5686_fb5fd24a-9da9-4461-b191-e1d932143502 55154-5686 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20101029 ANDA ANDA075640 Cardinal Health HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55154-5687_d4ce6e9d-c292-4ff7-95a6-81567a80122f 55154-5687 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20110114 ANDA ANDA076698 Cardinal Health METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 55154-5688_d4ce6e9d-c292-4ff7-95a6-81567a80122f 55154-5688 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20110114 ANDA ANDA076698 Cardinal Health METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 55154-5689_bf91b396-31ca-436a-9074-bceb9aaca13b 55154-5689 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20110513 ANDA ANDA088467 Cardinal Health HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 55154-5692_2359e42c-9e29-42f5-81d9-3ecea3b5c45c 55154-5692 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100114 ANDA ANDA076418 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55154-5696_7044eb67-f720-4c4c-9bd6-a90149cbf138 55154-5696 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20110114 ANDA ANDA076577 Cardinal Health MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 55154-5697_12d5bd57-e599-4fb7-8959-5f08b9497578 55154-5697 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040596 Cardinal Health PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 55154-5698_96a7cd70-edaf-4b39-801d-2700ca8f9d8e 55154-5698 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20120829 ANDA ANDA076919 Cardinal Health LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55154-5699_96a7cd70-edaf-4b39-801d-2700ca8f9d8e 55154-5699 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20120829 ANDA ANDA076919 Cardinal Health LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55154-5701_e1badec1-77bd-481a-a93c-3150eaeee814 55154-5701 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAVENOUS 19900930 ANDA ANDA018579 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 55154-5704_e1badec1-77bd-481a-a93c-3150eaeee814 55154-5704 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAVENOUS 19900930 ANDA ANDA018579 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 55154-5705_e1badec1-77bd-481a-a93c-3150eaeee814 55154-5705 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAVENOUS 19900930 ANDA ANDA018579 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 55154-5708_d6250d98-0884-4a3f-867c-528a460cf112 55154-5708 HUMAN PRESCRIPTION DRUG Dopamine HCl Dopamine HCl INJECTION, SOLUTION INTRAVENOUS 19900930 ANDA ANDA070820 Cardinal Health DOPAMINE HYDROCHLORIDE 80 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 55154-5712_d6250d98-0884-4a3f-867c-528a460cf112 55154-5712 HUMAN PRESCRIPTION DRUG Dopamine HCl Dopamine HCl INJECTION, SOLUTION INTRAVENOUS 19870211 ANDA ANDA070799 Cardinal Health DOPAMINE HYDROCHLORIDE 40 mg/mL Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 55154-5715_439404e2-b954-48f0-ba69-3674cc0658a9 55154-5715 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110707 UNAPPROVED DRUG OTHER Cardinal Health ATROPINE SULFATE .4 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 55154-5717_675771e3-db30-4e9c-928c-80f9fae924a3 55154-5717 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION INTRAVENOUS 20110614 UNAPPROVED DRUG OTHER Cardinal Health CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 55154-5722_315c5932-4abd-43b1-89d7-326e207448b3 55154-5722 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111025 ANDA ANDA089335 Cardinal Health GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 55154-5724_bd6a0d6e-562a-4364-81a5-c609f3936327 55154-5724 HUMAN PRESCRIPTION DRUG Vasopressin Vasopressin INJECTION INTRAMUSCULAR 20111017 UNAPPROVED DRUG OTHER Cardinal Health VASOPRESSIN 20 [USP'U]/mL E 20171231 55154-5730_711237e4-762e-4c45-8f03-80e648ed5e79 55154-5730 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine INHALANT ORAL; RESPIRATORY (INHALATION) 20110506 ANDA ANDA072489 Cardinal Health ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 55154-5731_711237e4-762e-4c45-8f03-80e648ed5e79 55154-5731 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine INHALANT ORAL; RESPIRATORY (INHALATION) 20110506 ANDA ANDA072547 Cardinal Health ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 55154-5732_439404e2-b954-48f0-ba69-3674cc0658a9 55154-5732 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110707 UNAPPROVED DRUG OTHER Cardinal Health ATROPINE SULFATE 1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 55154-5737_315c5932-4abd-43b1-89d7-326e207448b3 55154-5737 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111025 ANDA ANDA089335 Cardinal Health GLYCOPYRROLATE 1 mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 55154-5738_3d066575-f361-4fcc-b1f3-3ae2be447719 55154-5738 HUMAN PRESCRIPTION DRUG Sodium Phosphates sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous INJECTION, SOLUTION INTRAVENOUS 19900930 UNAPPROVED DRUG OTHER Cardinal Health SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 276; 142 mg/mL; mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 55154-5739_315c5932-4abd-43b1-89d7-326e207448b3 55154-5739 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111025 ANDA ANDA089335 Cardinal Health GLYCOPYRROLATE .4 mg/2mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 55154-5741_61ce2a92-df17-4994-bea0-edda0d6774bc 55154-5741 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20100211 ANDA ANDA090386 Cardinal Health METOPROLOL TARTRATE 1 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-5742_368a60fa-6cf0-4036-970e-e3a482f244ba 55154-5742 HUMAN PRESCRIPTION DRUG Nitroglycerin nitroglycerin INJECTION, SOLUTION INTRAVENOUS 20030304 ANDA ANDA072034 Cardinal Health NITROGLYCERIN 5 mg/mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 55154-5759_284f1e3c-45e4-40fc-a56a-bfacec331016 55154-5759 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110131 ANDA ANDA065265 Cardinal Health AZITHROMYCIN MONOHYDRATE 100 mg/mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 55154-5766_1cc0a042-d426-4969-9b8f-98be28d947c8 55154-5766 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20040601 ANDA ANDA076346 Cardinal Health TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 55154-5767_0548145e-6b20-4843-9bcc-cf270ea2f072 55154-5767 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20040601 ANDA ANDA076346 Cardinal Health TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 55154-5775_cacfeb5e-a7e7-49c7-a269-2dec76953d6c 55154-5775 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 19660730 ANDA ANDA074623 Cardinal Health LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 55154-5776_f10541de-6238-4014-becf-06f6c084dad3 55154-5776 HUMAN PRESCRIPTION DRUG Megestrol Acetate MEGESTROL ACETATE SUSPENSION ORAL 20060707 ANDA ANDA076721 Cardinal Health MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 55154-5821_2594e3d8-af38-4ba0-9370-0a261e2d1042 55154-5821 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20091207 ANDA ANDA088467 Cardinal Health HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 55154-5827_2594e3d8-af38-4ba0-9370-0a261e2d1042 55154-5827 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20091207 ANDA ANDA089097 Cardinal Health HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 55154-5837_e07ea561-9afe-40c7-8f3a-cfe228282a45 55154-5837 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 500 mg/1 E 20171231 55154-5840_cc7472f1-149d-4842-a742-bf8f1b895e93 55154-5840 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health IBUPROFEN 200 mg/1 E 20171231 55154-5842_edb534b0-2117-4c82-a835-602234fbb73c 55154-5842 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ACETAMINOPHEN 325 mg/1 E 20171231 55154-5844_fd03ff05-2c6d-4f10-a872-39efbf196bdb 55154-5844 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health BACITRACIN 500 1/1 E 20171231 55154-5868_2cb94b1b-abac-4def-b05f-c67d18620603 55154-5868 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20001201 ANDA ANDA065055 Cardinal Health DOXYCYCLINE 100 mg/1 E 20171231 55154-5875_9963c228-135c-4732-b6e9-64f072d98b0d 55154-5875 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20080326 NDA NDA018569 Cardinal Health FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-5876_3fef4b89-0043-4af1-87d0-077d95f267ab 55154-5876 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA075133 Cardinal Health LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-5877_a3c8fd94-4abf-406f-98da-f44fb6a8498a 55154-5877 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Cardinal Health OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-5878_45ac70ef-fd12-4957-823c-ac934efa2bad 55154-5878 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100324 ANDA ANDA076045 Cardinal Health LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-5880_2e10a8c7-fa76-405c-b1af-5beff0bcd5f6 55154-5880 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Cardinal Health SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-5881_55857ad1-7d09-4a66-9448-53aa7ef433b1 55154-5881 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 Cardinal Health RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-5882_d97b9069-b5a4-4027-9c8c-f40d735eaac9 55154-5882 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20090610 ANDA ANDA077002 Cardinal Health DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 55154-5884_62bd1f2c-76be-4569-bfb2-8c75cc4dd97c 55154-5884 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Cardinal Health ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55154-5885_f8c27119-357d-47b4-b7c7-72f91158f218 55154-5885 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Cardinal Health ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55154-5886_45ac70ef-fd12-4957-823c-ac934efa2bad 55154-5886 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100324 ANDA ANDA076045 Cardinal Health LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-5887_b0fbf5f9-d541-49c7-9c46-365cf61e6f81 55154-5887 HUMAN OTC DRUG peg 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091008 ANDA ANDA090685 Cardinal Health POLYETHYLENE GLYCOL 3350 17 g/17g E 20171231 55154-5888_1b351b55-0dc0-4b61-9bd3-c8d6d03b5472 55154-5888 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Cardinal Health METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 55154-5889_895aecf6-b52c-4891-84d8-9ba142cec4a7 55154-5889 HUMAN OTC DRUG Senna Plus standardized senna concentrate and docusate sodium TABLET ORAL 20100114 UNAPPROVED DRUG OTHER Cardinal Health SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 E 20171231 55154-5892_5ed5959e-803c-4ac6-86af-24171bfddd0f 55154-5892 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Cardinal Health LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-5895_e74a979c-859a-427a-aebd-e44a5376b4a0 55154-5895 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20091102 ANDA ANDA078216 Cardinal Health CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-5896_a3c8fd94-4abf-406f-98da-f44fb6a8498a 55154-5896 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Cardinal Health OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-5897_71663c22-85d3-4691-b906-e8a0909f8591 55154-5897 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131201 ANDA ANDA076710 Cardinal Health LEVOFLOXACIN 500 mg/1 N 20181231 55154-5898_71663c22-85d3-4691-b906-e8a0909f8591 55154-5898 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131201 ANDA ANDA076710 Cardinal Health LEVOFLOXACIN 750 mg/1 N 20181231 55154-5899_657e908b-3a34-4d76-9885-585a8194db51 55154-5899 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Cardinal Health RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 55154-5925_759fe013-c185-4373-ab70-cee4e7cd49c1 55154-5925 HUMAN PRESCRIPTION DRUG Pitressin vasopressin INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20071001 UNAPPROVED DRUG OTHER Cardinal Health VASOPRESSIN 20 [USP'U]/mL E 20171231 55154-5952_d11575fe-64be-446a-b464-89f43560e271 55154-5952 HUMAN PRESCRIPTION DRUG Pentasa mesalamine CAPSULE ORAL 19930510 NDA NDA020049 Cardinal Health MESALAMINE 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 55154-5953_21bc55ec-5f23-4d0b-9488-d5b08b7c0fc2 55154-5953 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate TABLET, CHEWABLE ORAL 20041026 NDA NDA021468 Cardinal Health LANTHANUM CARBONATE 500 mg/1 E 20171231 55154-5976_fd13743d-ec41-4782-8068-4a18d4a6eb4e 55154-5976 HUMAN PRESCRIPTION DRUG Metoclopramide hydrochloride Metoclopramide hydrochloride TABLET ORAL 19851017 ANDA ANDA070581 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 55154-5979_639c6a35-82b9-47df-92bf-f8b82f0e80c0 55154-5979 HUMAN PRESCRIPTION DRUG nifedipine nifedipine CAPSULE, LIQUID FILLED ORAL 19910108 ANDA ANDA072579 Cardinal Health NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55154-5981_98c12507-3579-41d5-8b38-2d298daceea6 55154-5981 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931031 ANDA ANDA074342 Cardinal Health ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-5982_98c12507-3579-41d5-8b38-2d298daceea6 55154-5982 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931031 ANDA ANDA074342 Cardinal Health ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-5983_98c12507-3579-41d5-8b38-2d298daceea6 55154-5983 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931031 ANDA ANDA074342 Cardinal Health ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-5992_939f7526-062f-48fd-9aee-4b068fd531be 55154-5992 HUMAN PRESCRIPTION DRUG Glipizide ER glipizide TABLET, EXTENDED RELEASE ORAL 19940426 NDA NDA020329 Cardinal Health GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 55154-5996_120de758-f102-470a-892d-a61b18ff8f71 55154-5996 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 20060115 ANDA ANDA080172 Cardinal Health PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] E 20171231 55154-6050_3f175b24-c1e8-4b91-b795-2a3e74087181 55154-6050 HUMAN OTC DRUG Feverall Acetaminophen SUPPOSITORY RECTAL 20110606 ANDA ANDA018337 Cardinal Health ACETAMINOPHEN 650 mg/1 E 20171231 55154-6125_48dc0f60-a62a-44db-b970-df043df6202e 55154-6125 HUMAN PRESCRIPTION DRUG BENICAR HCT olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Cardinal Health OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 55154-6126_e0ec7538-bdd7-489c-b976-be1330647aeb 55154-6126 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 20181031 NDA NDA021286 Cardinal Health OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 55154-6127_e0ec7538-bdd7-489c-b976-be1330647aeb 55154-6127 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 20181031 NDA NDA021286 Cardinal Health OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 55154-6128_48dc0f60-a62a-44db-b970-df043df6202e 55154-6128 HUMAN PRESCRIPTION DRUG BENICAR HCT olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Cardinal Health OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 55154-6129_48dc0f60-a62a-44db-b970-df043df6202e 55154-6129 HUMAN PRESCRIPTION DRUG BENICAR HCT olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Cardinal Health OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 55154-6130_ee62f4c5-0cd4-4b08-acf3-2b333dac5af9 55154-6130 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Cardinal Health OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 55154-6131_ee231277-3f77-4e82-a4ff-ead983b38563 55154-6131 HUMAN PRESCRIPTION DRUG BENICAR HCT olmesartan medoxomil and hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Cardinal Health OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 55154-6151_ac899907-83fb-4c12-8ec6-9335b1392462 55154-6151 HUMAN OTC DRUG Senna-S Senna Concentrate/Docusate Sodium TABLET ORAL 20110603 UNAPPROVED DRUG OTHER Cardinal Health DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 E 20171231 55154-6163_a5ea0a61-bc61-45b5-90e1-37baa5326117 55154-6163 HUMAN OTC DRUG Senna Gen Sennosides TABLET ORAL 20110607 UNAPPROVED DRUG OTHER Cardinal Health SENNOSIDES 8.6 mg/1 E 20171231 55154-6164_08f4fa96-9b39-436a-acad-747c53fc30a8 55154-6164 HUMAN PRESCRIPTION DRUG Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride TABLET ORAL 20091009 ANDA ANDA076089 Cardinal Health CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 55154-6177_08f4fa96-9b39-436a-acad-747c53fc30a8 55154-6177 HUMAN PRESCRIPTION DRUG Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride TABLET ORAL 20091009 ANDA ANDA076089 Cardinal Health CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 55154-6178_bf6157b3-b561-43db-9c62-14ac48d72358 55154-6178 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20101201 ANDA ANDA076077 Cardinal Health FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 55154-6187_08f4fa96-9b39-436a-acad-747c53fc30a8 55154-6187 HUMAN PRESCRIPTION DRUG Ciprofloxacin hydrochloride Ciprofloxacin hydrochloride TABLET ORAL 20091009 ANDA ANDA076089 Cardinal Health CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 55154-6188_8c6b6588-d4a2-4377-a113-931666db2a9a 55154-6188 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20040428 ANDA ANDA076017 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-6194_bf6157b3-b561-43db-9c62-14ac48d72358 55154-6194 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20101201 ANDA ANDA076077 Cardinal Health FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 55154-6239_bc3ecbf6-0abe-44bf-97a4-630fb5b92320 55154-6239 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20020621 ANDA ANDA075986 Cardinal Health TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 55154-6242_2a585868-c41d-499a-9d81-e3a152e8ab44 55154-6242 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 20091217 ANDA ANDA040326 Cardinal Health ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 55154-6243_4b6435e3-d102-449f-b21b-ac53130b3c78 55154-6243 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090921 ANDA ANDA074425 Cardinal Health PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] E 20171231 55154-6256_49f50d5e-3738-4f3a-8999-28c6a5ff2cd7 55154-6256 HUMAN PRESCRIPTION DRUG Tizanidine tizanidine TABLET ORAL 20130321 ANDA ANDA076354 Cardinal Health TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 55154-6260_0e309571-0af7-462b-af2e-dad3129ce014 55154-6260 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20090828 ANDA ANDA078309 Cardinal Health LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 55154-6262_c46a0b74-e2c1-4436-9d16-d0119407ba94 55154-6262 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil CAPSULE ORAL 20111025 ANDA ANDA065520 Cardinal Health MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 55154-6263_dfe06d6b-eb1c-489f-b32c-d3ed00c4db04 55154-6263 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20120123 ANDA ANDA090970 Cardinal Health PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 55154-6281_96ed1f15-4e25-454e-a01b-41c2a03079df 55154-6281 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20121005 ANDA ANDA076071 Cardinal Health LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 55154-6295_8f5ff9cb-9ab1-4a05-939b-b4296b27f7e2 55154-6295 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron TABLET, FILM COATED ORAL 20121205 ANDA ANDA076930 Cardinal Health ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55154-6296_2ecc6c55-0129-4f80-a8eb-6a9e6984bd93 55154-6296 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20121214 ANDA ANDA075973 Cardinal Health METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55154-6297_23240d8b-b430-4474-9c68-7a860cc28dcc 55154-6297 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090903 ANDA ANDA070317 Cardinal Health CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 55154-6298_0ecc3aa8-eb0e-45dc-b04e-44e68faddd4e 55154-6298 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130520 ANDA ANDA076644 Cardinal Health OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 55154-6328_0d008651-e2b5-4b48-a5f3-60f70bb3766a 55154-6328 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831130 ANDA ANDA018413 Cardinal Health FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 55154-6330_0d008651-e2b5-4b48-a5f3-60f70bb3766a 55154-6330 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831130 ANDA ANDA018413 Cardinal Health FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 55154-6342_194624ee-725e-43a0-a56c-994676b6fc2e 55154-6342 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091109 ANDA ANDA071321 Cardinal Health DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55154-6343_66438469-77d4-42b0-90d0-09b6a59baeb3 55154-6343 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19820101 ANDA ANDA083177 Cardinal Health HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 55154-6344_194624ee-725e-43a0-a56c-994676b6fc2e 55154-6344 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091109 ANDA ANDA071322 Cardinal Health DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55154-6349_b5580eb5-2f1c-44fb-aca6-138b872f249f 55154-6349 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED ORAL 20100901 ANDA ANDA065110 Cardinal Health CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 55154-6475_fa522c16-4e1e-4e10-98a6-476bcee4a6a7 55154-6475 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20110926 ANDA ANDA077319 Cardinal Health LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-6526_a3c605f4-2b91-4148-9219-e38d3e01f93f 55154-6526 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE, COATED ORAL 20010314 ANDA ANDA065028 Cardinal Health RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 55154-6625_a15f62e4-fa53-4235-a719-6f099d9b7927 55154-6625 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130626 ANDA ANDA040148 Cardinal Health HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 55154-6627_aedddea8-f259-47c5-b077-1cb8eff8dac0 55154-6627 HUMAN PRESCRIPTION DRUG Sertraline Sertraline Hydrochloride TABLET ORAL 20130705 ANDA ANDA077397 Cardinal Health SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-6628_f90e7e59-20a8-4733-94b2-7cef8e0b7710 55154-6628 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20100910 ANDA ANDA086242 Cardinal Health HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 55154-6629_818d8158-f365-4047-9305-f822691e31ae 55154-6629 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20101007 ANDA ANDA078938 Cardinal Health TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 55154-6630_275a8e6f-2cbf-46c3-96d7-9204da74b493 55154-6630 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20050922 ANDA ANDA078402 Cardinal Health LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 55154-6631_aedddea8-f259-47c5-b077-1cb8eff8dac0 55154-6631 HUMAN PRESCRIPTION DRUG Sertraline Sertraline Hydrochloride TABLET ORAL 20130705 ANDA ANDA077397 Cardinal Health SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-6634_69035322-bd0b-42fb-a00d-b614f5390de3 55154-6634 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130709 ANDA ANDA090548 Cardinal Health ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-6635_69035322-bd0b-42fb-a00d-b614f5390de3 55154-6635 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130709 ANDA ANDA090548 Cardinal Health ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-6637_b2a3c16b-cf37-42c1-bf20-2e679767a2ab 55154-6637 HUMAN PRESCRIPTION DRUG Divalproex Sodium DR Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20091014 ANDA ANDA078790 Cardinal Health DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55154-6638_275a8e6f-2cbf-46c3-96d7-9204da74b493 55154-6638 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20050922 ANDA ANDA078402 Cardinal Health LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 55154-6639_aedddea8-f259-47c5-b077-1cb8eff8dac0 55154-6639 HUMAN PRESCRIPTION DRUG Sertraline Sertraline Hydrochloride TABLET ORAL 20101215 20180430 ANDA ANDA077397 Cardinal Health SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-6640_72ee50ed-cec5-4bf0-bd1d-b7efb569a1ea 55154-6640 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20110519 ANDA ANDA077584 Cardinal Health PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 55154-6642_f3544242-c078-490e-b419-ad165d44a30c 55154-6642 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20091105 NDA NDA019594 Cardinal Health URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] E 20171231 55154-6643_12ea6a0b-fa9d-4c13-a495-038f795f7e77 55154-6643 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20130613 ANDA ANDA078243 Cardinal Health LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55154-6644_891913a5-dfae-41d0-92de-2aa852ac714d 55154-6644 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20080703 ANDA ANDA077614 Cardinal Health CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 55154-6645_0093b1a1-b64e-4196-a3aa-1388ed724a3b 55154-6645 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate Fludrocortisone Acetate TABLET ORAL 20080509 ANDA ANDA040431 Cardinal Health FLUDROCORTISONE ACETATE .1 mg/1 N 20191231 55154-6646_69035322-bd0b-42fb-a00d-b614f5390de3 55154-6646 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130709 ANDA ANDA090548 Cardinal Health ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-6647_4587de2e-1dcf-452c-8498-6dcb17670516 55154-6647 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 20100113 ANDA ANDA075079 Cardinal Health OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 55154-6648_f8e2c53d-b618-44a5-92a7-c32c87ae73b5 55154-6648 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20091207 ANDA ANDA075576 Cardinal Health OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55154-6649_4824de59-7ce4-4c9b-bd1a-de316309d01d 55154-6649 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130701 ANDA ANDA090432 Cardinal Health ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-6658_f1977b44-59b9-4e5e-802f-d201ef5c8783 55154-6658 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA077884 Cardinal Health ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 55154-6659_f1977b44-59b9-4e5e-802f-d201ef5c8783 55154-6659 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA077884 Cardinal Health ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 55154-6660_001714c1-a292-40be-bfbd-0ff67193ace6 55154-6660 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide citalopram hydrobromide TABLET, FILM COATED ORAL 20041124 ANDA ANDA077046 Cardinal Health CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-6661_001714c1-a292-40be-bfbd-0ff67193ace6 55154-6661 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide citalopram hydrobromide TABLET, FILM COATED ORAL 20041124 ANDA ANDA077046 Cardinal Health CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-6664_94411cd4-5bb2-423f-ab5f-9685b5f1444c 55154-6664 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Cardinal Health TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 55154-6666_b8f1ffb7-f089-44bb-8376-1ad775250de7 55154-6666 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051007 20181130 ANDA ANDA065226 Cardinal Health CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 55154-6668_8723966e-1227-451c-8b24-1b0c9275c154 55154-6668 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120420 ANDA ANDA065226 Cardinal Health CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55154-6669_b7af2381-b8cc-45ac-b81e-47a36e4150a5 55154-6669 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 20181231 ANDA ANDA075360 Cardinal Health GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55154-6670_b7af2381-b8cc-45ac-b81e-47a36e4150a5 55154-6670 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 20181231 ANDA ANDA075360 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55154-6671_acc19269-1a54-4a0d-92dd-e4e7a69ed7b0 55154-6671 HUMAN PRESCRIPTION DRUG cilostazol cilostazol TABLET ORAL 20111018 ANDA ANDA077030 Cardinal Health CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20191231 55154-6672_2996290f-db34-43eb-b627-573e23f61f7e 55154-6672 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA091265 Cardinal Health OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-6673_22ca32d1-4e82-4b5e-a280-de6e3103a8ac 55154-6673 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Cardinal Health PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-6676_e966546e-8a66-43c2-8432-d7139dc7e770 55154-6676 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20050124 ANDA ANDA076471 Cardinal Health LORATADINE 10 mg/1 E 20171231 55154-6677_26e10b43-5221-4e4b-9ec6-89d5b4c5711f 55154-6677 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Cardinal Health MIRTAZAPINE 15 mg/1 E 20171231 55154-6678_b7af2381-b8cc-45ac-b81e-47a36e4150a5 55154-6678 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 20181231 ANDA ANDA075360 Cardinal Health GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55154-6685_531147fd-0878-4140-8c3b-20c36ff0d06f 55154-6685 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Cardinal Health OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 55154-6704_10db41e7-12e1-4ffe-9b06-ca5839e7c029 55154-6704 HUMAN OTC DRUG Bisacodyl Bisacodyl SUPPOSITORY RECTAL 20110602 OTC MONOGRAPH NOT FINAL part334 Cardinal Health BISACODYL 10 mg/1 N 20191231 55154-6705_978dd69b-c349-485b-bdf3-672b97890dcc 55154-6705 HUMAN OTC DRUG Bisacodyl Bisacodyl TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health BISACODYL 5 mg/1 E 20171231 55154-6707_10d9bf5d-b35d-41ac-9405-81890cbf5e6a 55154-6707 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20060524 ANDA ANDA077893 Cardinal Health POLYETHYLENE GLYCOL 3350 17 g/17g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20191231 55154-6725_eae9d6b4-ad45-4c07-ad22-e2179c65884d 55154-6725 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 20180831 NDA NDA020405 Cardinal Health DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 55154-6726_7427b94a-c532-443a-9bac-459463dccc4d 55154-6726 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Cardinal Health DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20191231 55154-6752_1f1cd592-a1b5-4636-a8a0-70342f0fb776 55154-6752 HUMAN OTC DRUG Childrens Aspirin Aspirin TABLET, CHEWABLE ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Helath ASPIRIN 81 mg/1 E 20171231 55154-6754_c34205da-9931-4ae6-8070-43c4dee4385e 55154-6754 HUMAN OTC DRUG Sodium Bicarbonate Sodium Bicarbonate TABLET ORAL 20110606 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE 650 mg/1 N 20191231 55154-6755_523b3ffd-9965-4703-83e7-c7d98cebf93a 55154-6755 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20110602 UNAPPROVED DRUG OTHER Cardinal Health ASPIRIN 325 mg/1 E 20171231 55154-6775_fcab4c61-9bfd-40ad-8389-65e077abd787 55154-6775 HUMAN PRESCRIPTION DRUG COLAZAL balsalazide disodium CAPSULE ORAL 20000718 NDA NDA020610 Cardinal Health BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 55154-6777_e8419cdb-d5a4-4aab-a009-21262ed582ff 55154-6777 HUMAN PRESCRIPTION DRUG XIFAXAN rifaximin TABLET ORAL 20100501 NDA NDA021361 Cardinal Health RIFAXIMIN 550 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 55154-6809_f9d457d2-6714-4141-be0b-376c85ce10ee 55154-6809 HUMAN OTC DRUG Calgest Calgest TABLET ORAL 19960123 OTC MONOGRAPH FINAL part331 Cardinal Health CALCIUM CARBONATE 500 mg/1 E 20171231 55154-6812_44c81163-4cdc-4399-9dd0-3e5febf987fc 55154-6812 HUMAN OTC DRUG EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM 250 mg/1 E 20171231 55154-6815_a13d04f1-ee16-4733-b379-eb61ef3c0d09 55154-6815 HUMAN OTC DRUG Sodium Bicarbonate Antacid Sodium Bicarbonate TABLET ORAL 20100308 OTC MONOGRAPH FINAL part331 Cardinal Health SODIUM BICARBONATE 650 mg/1 E 20171231 55154-6817_a8a2a988-956f-44f1-8442-66743953b9ae 55154-6817 HUMAN OTC DRUG Stool Softener Extra Strength Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150131 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM 250 mg/1 E 20171231 55154-6825_3fc428dc-47a0-4997-8b32-e68bfd4f6ca1 55154-6825 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110725 ANDA ANDA078010 Cardinal Health FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 55154-6826_27ffb185-0ea7-4a9d-9e91-d525b27d018c 55154-6826 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20090617 ANDA ANDA075682 Cardinal Health IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 55154-6827_d2cc8a1d-8a84-444b-b5a7-19ef0917fea2 55154-6827 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20070806 ANDA ANDA063083 Cardinal Health CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 55154-6828_00bbbd85-6b44-4365-b89f-9933369a35f1 55154-6828 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength Aspirin TABLET, DELAYED RELEASE ORAL 20130628 OTC MONOGRAPH FINAL part343 Cardinal Health ASPIRIN 325 mg/3251 N 20191231 55154-6830_dbdad0a3-4ec8-4953-bed1-1663cb8da471 55154-6830 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20111101 ANDA ANDA079107 Cardinal Health LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-6831_9ed114aa-92cb-4d86-9c2b-8aefee4696c7 55154-6831 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20070801 ANDA ANDA074869 Cardinal Health CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-6834_dd72febe-7848-42bf-9eef-886e3e8fde24 55154-6834 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110317 ANDA ANDA078374 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 55154-6835_51dd983b-d8b8-485a-a015-d867bed130f2 55154-6835 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Cardinal Health IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 55154-6836_be6731ba-8e63-4ba0-a2a5-c68202286746 55154-6836 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070724 20181031 ANDA ANDA074984 Cardinal Health DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 55154-6837_c7db0cf5-10f0-46e6-98a8-8d8c6cde4227 55154-6837 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20110523 ANDA ANDA090682 Cardinal Health VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 55154-6838_dd72febe-7848-42bf-9eef-886e3e8fde24 55154-6838 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110317 ANDA ANDA078374 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 55154-6841_51dd983b-d8b8-485a-a015-d867bed130f2 55154-6841 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Cardinal Health IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 55154-6843_97615282-1f8a-4a95-af9a-82de0bda7d32 55154-6843 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Cardinal Health FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 55154-6844_26fe6e81-3e29-4536-8f45-4cb8bb515587 55154-6844 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20070701 ANDA ANDA078220 Cardinal Health BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 55154-6845_915f731f-1337-45c6-86a9-b28340ff6d2c 55154-6845 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Cardinal Health GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55154-6846_915f731f-1337-45c6-86a9-b28340ff6d2c 55154-6846 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Cardinal Health GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55154-6847_f5c64f0b-3bc9-49d2-a11e-bbaa3564419d 55154-6847 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20121126 ANDA ANDA076514 Cardinal Health MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 55154-6875_aa875881-5aba-4ef4-a151-863b0dd04aef 55154-6875 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130120 ANDA ANDA078226 Cardinal Health AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55154-6877_3fef4b89-0043-4af1-87d0-077d95f267ab 55154-6877 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20090610 ANDA ANDA075133 Cardinal Health LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-6878_a3c8fd94-4abf-406f-98da-f44fb6a8498a 55154-6878 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Cardinal Health OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-6879_a204066f-d161-4c81-aa19-6e674599c1ba 55154-6879 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20040304 ANDA ANDA071972 Cardinal Health PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-6880_f8c27119-357d-47b4-b7c7-72f91158f218 55154-6880 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Cardinal Health ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55154-6881_7380e549-33ea-4379-b7fd-cdce5dc80845 55154-6881 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Cardinal Health OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 55154-6882_657e908b-3a34-4d76-9885-585a8194db51 55154-6882 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20131130 ANDA ANDA079088 Cardinal Health RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 55154-6883_668af82c-1119-4aa0-9b1f-837b7a09d42b 55154-6883 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Cardinal Health CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 55154-6884_668af82c-1119-4aa0-9b1f-837b7a09d42b 55154-6884 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Cardinal Health CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 55154-6885_668af82c-1119-4aa0-9b1f-837b7a09d42b 55154-6885 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Cardinal Health CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 55154-6886_e44a3810-64d7-490b-af07-911d031227b4 55154-6886 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Cardinal Health METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-6888_5407b8ff-b4b1-48cf-91b5-28f35623b59b 55154-6888 HUMAN OTC DRUG Banophen Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 55154-6889_7380e549-33ea-4379-b7fd-cdce5dc80845 55154-6889 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA076255 Cardinal Health OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 55154-6890_d1dff7bb-6b46-45d8-8871-3eff38998d48 55154-6890 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20070216 ANDA ANDA076001 Cardinal Health FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-6891_701941f1-9f55-4d28-b5a2-922a5574ae1d 55154-6891 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride 5 mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20140615 ANDA ANDA201724 Cardinal Health DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 55154-6892_aa875881-5aba-4ef4-a151-863b0dd04aef 55154-6892 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20130120 ANDA ANDA078226 Cardinal Health AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55154-6893_a9860ef9-c631-469d-8041-803ed53b6e8e 55154-6893 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20141015 ANDA ANDA090939 Cardinal Health ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-6894_673aad21-c998-45e3-80dc-7c9199eae475 55154-6894 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20130825 ANDA ANDA202871 Cardinal Health METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-6895_673aad21-c998-45e3-80dc-7c9199eae475 55154-6895 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20130825 ANDA ANDA202871 Cardinal Health METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-6896_0e999cbc-7a36-43fb-a1e1-94eccd5207fb 55154-6896 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Cardinal Health DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55154-6897_60fff200-96a5-491f-8d73-61d67fa85666 55154-6897 HUMAN OTC DRUG Unit Dose Bisacodyl Bisacodyl TABLET, COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Cardinal Health BISACODYL 5 mg/1 N 20191231 55154-6898_71663c22-85d3-4691-b906-e8a0909f8591 55154-6898 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131201 ANDA ANDA076710 Cardinal Health LEVOFLOXACIN 250 mg/1 N 20181231 55154-6899_82b9b133-48b7-4dae-a4f1-5366ab847f39 55154-6899 HUMAN OTC DRUG PEG 3350 POLYETHYLENE GLYCOL 3350 POWDER ORAL 20150304 ANDA ANDA091077 Cardinal Health POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 55154-6909_bb3580b7-14aa-44ae-9c69-1aee59b92c1c 55154-6909 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Cardinal Health QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-6910_bb3580b7-14aa-44ae-9c69-1aee59b92c1c 55154-6910 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Cardinal Health QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-6918_bb3580b7-14aa-44ae-9c69-1aee59b92c1c 55154-6918 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Cardinal Health QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-6920_bb3580b7-14aa-44ae-9c69-1aee59b92c1c 55154-6920 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Cardinal Health QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-6921_1879ea01-413e-43ad-8ceb-b3f7413bcbbd 55154-6921 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 55154-6922_a9086349-8827-46b6-a17f-e8c61df14a5e 55154-6922 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 20180831 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 55154-6923_a9086349-8827-46b6-a17f-e8c61df14a5e 55154-6923 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 20180331 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 55154-6924_a9086349-8827-46b6-a17f-e8c61df14a5e 55154-6924 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 55154-6925_a9086349-8827-46b6-a17f-e8c61df14a5e 55154-6925 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 20180831 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 55154-6926_6a121933-1f2d-4fc3-bd85-fe2791275355 55154-6926 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20101201 20180930 NDA NDA021366 Cardinal Health ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 55154-6931_4c5ccb81-68ef-4054-823f-308ae5445f58 55154-6931 HUMAN PRESCRIPTION DRUG ONGLYZA SAXAGLIPTIN TABLET, FILM COATED ORAL 20141120 NDA NDA022350 Cardinal Health SAXAGLIPTIN HYDROCHLORIDE 5 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20191231 55154-6950_18ff4820-4f1d-4a36-8800-3b0e189a97af 55154-6950 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089646 Cardinal Health LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 20; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55154-6955_701c3b61-dc2c-4de6-9a85-d4ab93b33a3d 55154-6955 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 Cardinal Health LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] E 20171231 55154-6959_26b7e6a0-1674-47cd-9b60-97d7228a5f95 55154-6959 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 20100107 ANDA ANDA070584 Cardinal Health BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55154-6960_3ba7e84c-6192-4925-9f71-a0dbc6105253 55154-6960 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110727 ANDA ANDA074802 Cardinal Health KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 55154-6961_ef16311d-2e90-44fa-925e-ee60de8d39a4 55154-6961 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110908 NDA NDA018803 Cardinal Health SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 55154-6963_60b30ce9-fa63-46ac-b01e-3fff787134ad 55154-6963 HUMAN PRESCRIPTION DRUG Diazepam Diazepam INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19881220 ANDA ANDA072079 Cardinal Health DIAZEPAM 10 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55154-6964_0bd02665-6ce2-4736-8386-ca9d76b7bc66 55154-6964 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088327 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 55154-6965_553240ad-2b80-4ab4-b229-8eaf5e755a84 55154-6965 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN Base Filmtab ERYTHROMYCIN TABLET, FILM COATED ORAL 20110908 ANDA ANDA061621 Cardinal Health ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 55154-6966_2c89e2a0-b0c8-4118-a777-74d97a1eda29 55154-6966 HUMAN PRESCRIPTION DRUG TRICOR fenofibrate TABLET ORAL 20041105 NDA NDA021656 Cardinal Health FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 55154-6967_2c89e2a0-b0c8-4118-a777-74d97a1eda29 55154-6967 HUMAN PRESCRIPTION DRUG TRICOR fenofibrate TABLET ORAL 20041105 NDA NDA021656 Cardinal Health FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 55154-6969_4fda95bc-84c7-4dea-9178-a0852507eda7 55154-6969 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride lidocaine hydrochloride INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100330 ANDA ANDA088327 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 55154-6970_26b7e6a0-1674-47cd-9b60-97d7228a5f95 55154-6970 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 20100106 ANDA ANDA070583 Cardinal Health BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55154-6971_d29c37d8-cb3d-4bf8-9274-02b840295484 55154-6971 HUMAN PRESCRIPTION DRUG ZEMPLAR paricalcitol CAPSULE, LIQUID FILLED ORAL 20050526 NDA NDA021606 Cardinal Health PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 55154-6973_0bd02665-6ce2-4736-8386-ca9d76b7bc66 55154-6973 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088299 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 55154-6976_ea2ddd22-3e06-45f6-8a09-ada7d8acd4d6 55154-6976 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20061226 ANDA ANDA077548 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 55154-6977_5bfed326-e322-4958-be02-1bbfbd947761 55154-6977 HUMAN PRESCRIPTION DRUG Dextrose DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20110629 NDA NDA019445 Cardinal Health DEXTROSE MONOHYDRATE 25 g/50mL N 20191231 55154-6978_164589b1-cd3d-4fde-880b-1318fe62f789 55154-6978 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100405 ANDA ANDA089646 Cardinal Health LIDOCAINE HYDROCHLORIDE; EPINEPHRINE 20; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55154-6979_8d0189e7-b00f-4bd4-b532-64d132f02514 55154-6979 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110908 NDA NDA018803 Cardinal Health SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55154-6980_09bdd6dd-5680-414f-9232-b4120fae39a6 55154-6980 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110708 ANDA ANDA070256 Cardinal Health NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20191231 55154-6981_9553c152-2b18-4c09-8a4f-35e2a5a37b3b 55154-6981 HUMAN PRESCRIPTION DRUG Atropine Sulfate ATROPINE SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20051025 UNAPPROVED DRUG OTHER Cardinal Health ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 55154-6982_f915ddb4-fef2-45f4-9880-8ce8c55666e7 55154-6982 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110325 ANDA ANDA070737 Cardinal Health VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 55154-6983_dbdf706d-8fda-4fac-93cd-0c4bfb7220b7 55154-6983 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088325 Cardinal Health LIDOCAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-6984_dbdf706d-8fda-4fac-93cd-0c4bfb7220b7 55154-6984 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088328 Cardinal Health LIDOCAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-6985_eab36609-301e-462c-a16c-1ed7d151e38f 55154-6985 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090831 ANDA ANDA090571 Cardinal Health HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 55154-6986_a70a9886-743e-487c-883a-aaeebb62e0e8 55154-6986 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110708 ANDA ANDA089069 Cardinal Health PROCAINAMIDE HYDROCHLORIDE 100 mg/mL Antiarrhythmic [EPC] E 20171231 55154-6987_aa4b12fd-8cd7-452e-b326-c538c2830290 55154-6987 HUMAN PRESCRIPTION DRUG Aminophylline Aminophylline Dihydrate INJECTION, SOLUTION INTRAVENOUS 20110211 ANDA ANDA087242 Cardinal Health AMINOPHYLLINE DIHYDRATE 25 mg/mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20191231 55154-6989_eab36609-301e-462c-a16c-1ed7d151e38f 55154-6989 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090831 ANDA ANDA090571 Cardinal Health HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 55154-6990_d3028c7c-8d60-4056-861f-32a79ad6068f 55154-6990 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20110325 ANDA ANDA070737 Cardinal Health VERAPAMIL HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 55154-6991_25446996-576c-4692-b25a-fb068409c0ca 55154-6991 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL 20100106 ANDA ANDA070583 Cardinal Health BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55154-6992_dbdf706d-8fda-4fac-93cd-0c4bfb7220b7 55154-6992 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100330 ANDA ANDA088327 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55154-6994_13541c3c-b57b-48db-aa54-f23a10c21f28 55154-6994 HUMAN PRESCRIPTION DRUG Diazepam DIAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19871013 ANDA ANDA071583 Cardinal Health DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-6995_f05c5f2b-0dcd-43e3-986d-4d8e35d1dd79 55154-6995 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 19850418 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE 84 mg/mL N 20191231 55154-6996_7b6bb9e9-4e5e-4e01-9077-0a4182a85e91 55154-6996 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20050131 ANDA ANDA088100 Cardinal Health HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 55154-6997_506c80c2-5054-4ccd-b389-d0b159a9216c 55154-6997 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20020613 ANDA ANDA075856 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-6998_ba769b36-2d43-456e-a336-95e2b52cd031 55154-6998 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120306 ANDA ANDA070172 Cardinal Health NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 55154-6999_11796698-4626-4912-b584-185003f40317 55154-6999 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19720316 ANDA ANDA080205 Cardinal Health POTASSIUM CHLORIDE 149 mg/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 55154-7075_7359afc0-4d5a-48e5-9fb4-2f0fb07da84f 55154-7075 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Cardinal Health DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 55154-7076_df4d0346-3799-44bb-84fa-f6b0c30166c9 55154-7076 HUMAN PRESCRIPTION DRUG HALOPERIDOL LACTATE HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20110510 ANDA ANDA078347 Cardinal Health HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20191231 55154-7125_8c249a95-0b59-4007-8782-95ff563d44a8 55154-7125 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20131015 ANDA ANDA086925 Cardinal Health ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 55154-7126_1180e8bd-98e0-47bc-9f34-7656a5c9a6b2 55154-7126 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20130723 ANDA ANDA070581 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 55154-7127_586d5c77-6a1c-4600-808e-5ea6b724d0f8 55154-7127 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20130204 ANDA ANDA078619 Cardinal Health FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-7128_d67e7022-4211-44bc-ae57-6c18ce84d9fa 55154-7128 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20130322 ANDA ANDA065095 Cardinal Health DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 55154-7129_3863d801-5a27-4e38-bc65-c577cc92f502 55154-7129 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140701 ANDA ANDA075350 Cardinal Health GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 55154-7130_f37d8d11-ea44-4e45-a239-43f76316197e 55154-7130 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20140120 ANDA ANDA090429 Cardinal Health ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 55154-7131_3863d801-5a27-4e38-bc65-c577cc92f502 55154-7131 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140701 ANDA ANDA075350 Cardinal Health GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 55154-7132_ec562a2c-2a21-422a-99cc-c32303658551 55154-7132 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20141103 ANDA ANDA078926 Cardinal Health GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55154-7133_c64256b5-dff8-4c9d-a48f-e397955a62b7 55154-7133 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20140607 ANDA ANDA090493 Cardinal Health DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 55154-7134_8b2c36bc-2fe3-4113-aa88-b6a19d18d4c4 55154-7134 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140512 ANDA ANDA078889 Cardinal Health METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 55154-7135_0f3f62eb-08e4-4ac5-bc17-41ed054d2626 55154-7135 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20131014 ANDA ANDA078558 Cardinal Health IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55154-7136_8890fedd-f8ad-465b-9062-3486e9b2796c 55154-7136 HUMAN OTC DRUG healthylax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20110201 ANDA ANDA090812 Cardinal Health POLYETHYLENE GLYCOL 3350 17 g/17g N 20191231 55154-7137_732010db-36c5-4417-8813-1ebf20aba684 55154-7137 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130626 ANDA ANDA090200 Cardinal Health METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 55154-7138_db997e9c-d1e9-4f35-8861-6e60d66b16e8 55154-7138 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20150811 ANDA ANDA077731 Cardinal Health FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 55154-7139_7140d3bd-5691-4b8e-9258-f315055e433c 55154-7139 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150115 ANDA ANDA070044 Cardinal Health METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 55154-7140_28ed7db8-2c0b-4071-99a8-d04068159e5b 55154-7140 HUMAN PRESCRIPTION DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL 20080925 ANDA ANDA076856 Cardinal Health DANTROLENE SODIUM 25 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20191231 55154-7141_a548d66c-1eb5-40d5-8426-0b21595b0d06 55154-7141 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20051031 ANDA ANDA076921 Cardinal Health MIRTAZAPINE 30 mg/1 N 20191231 55154-7142_1a3111c1-ab75-477b-baed-5c231aef59ed 55154-7142 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20120601 ANDA ANDA078235 Cardinal Health TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55154-7143_70d66ce5-74ad-499c-ad0c-206fae315914 55154-7143 HUMAN PRESCRIPTION DRUG Hydroxyurea Hydroxyurea CAPSULE ORAL 20080812 ANDA ANDA075340 Cardinal Health HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] N 20181231 55154-7145_c1ab0571-ba93-40c9-acec-9982458ac05a 55154-7145 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141007 ANDA ANDA090554 Cardinal Health DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55154-7146_1a3111c1-ab75-477b-baed-5c231aef59ed 55154-7146 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20120601 ANDA ANDA078235 Cardinal Health TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55154-7147_92a81a1f-698b-4db0-b5a6-f7562abd9a32 55154-7147 HUMAN PRESCRIPTION DRUG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET ORAL 20120601 ANDA ANDA040511 Cardinal Health BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 55154-7148_a91126d2-a435-4209-9545-cc1fbc651215 55154-7148 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20110901 20181231 ANDA ANDA040653 Cardinal Health GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 55154-7149_ec562a2c-2a21-422a-99cc-c32303658551 55154-7149 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20140901 ANDA ANDA078926 Cardinal Health GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55154-7211_90b553fe-4e94-4cce-b5df-ea3e6487930d 55154-7211 HUMAN PRESCRIPTION DRUG KEPPRA levetiracetam INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060731 NDA NDA021872 Cardinal Health LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-7225_4a4dc781-9955-45b8-82a3-75034dd39ccc 55154-7225 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 Cardinal Health OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 55154-7229_381eb117-d525-4cb4-af05-9ef7d750dc18 55154-7229 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 ANDA ANDA077754 Cardinal Health LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-7230_9d309fd5-a5b2-479d-9a83-ed00fad2ac29 55154-7230 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20020301 UNAPPROVED DRUG OTHER Cardinal Health PHENOBARBITAL 16.2 mg/1 CIV E 20171231 55154-7231_9d309fd5-a5b2-479d-9a83-ed00fad2ac29 55154-7231 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20030201 UNAPPROVED DRUG OTHER Cardinal Health PHENOBARBITAL 32.4 mg/1 CIV E 20171231 55154-7257_dad4bbdd-4669-4656-a469-a8a1849d8bcb 55154-7257 HUMAN PRESCRIPTION DRUG RESTORIL temazepam CAPSULE ORAL 20081120 NDA NDA018163 Cardinal Health TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-7261_9b0ad1b1-d566-4f77-b02e-310624990d99 55154-7261 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040405 Cardinal Health HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 55154-7269_386a2331-2804-4da5-a0a8-a43d7d2d0711 55154-7269 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040409 Cardinal Health HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 55154-7271_386a2331-2804-4da5-a0a8-a43d7d2d0711 55154-7271 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040405 Cardinal Health HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 55154-7273_386a2331-2804-4da5-a0a8-a43d7d2d0711 55154-7273 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040400 Cardinal Health HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 55154-7325_6d7f32dd-1ff5-4a26-8f21-73a0a6a1922b 55154-7325 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride POWDER, FOR SOLUTION ORAL 20131009 UNAPPROVED DRUG OTHER Cardinal Health POTASSIUM CHLORIDE 1.5 g/1.74g Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 55154-7350_e274bd23-5747-409b-8db4-02fa8f3ded16 55154-7350 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Cardinal Health QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-7352_2c744bba-0537-467d-b6d9-9b9b7f922f6e 55154-7352 HUMAN OTC DRUG Oracit Oral Citrate LIQUID ORAL 20110607 UNAPPROVED DRUG OTHER Cardinal Health CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE 490; 640 mg/5mL; mg/5mL E 20171231 55154-7353_cb0f4a4e-2c73-4169-a772-208156e5dd1e 55154-7353 HUMAN PRESCRIPTION DRUG Sodium Polystyrene Sulfonate sodium polystyrene sulfonate SUSPENSION ORAL; RECTAL 19830101 ANDA ANDA087859 Cardinal Health SODIUM POLYSTYRENE SULFONATE 15 g/60mL N 20181231 55154-7375_e274bd23-5747-409b-8db4-02fa8f3ded16 55154-7375 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Cardinal Health QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-7376_e274bd23-5747-409b-8db4-02fa8f3ded16 55154-7376 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Cardinal Health QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-7452_3b9e0411-1dc7-418c-b0d3-fa4661efe868 55154-7452 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 Cardinal Health BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 55154-7453_2c996dee-ecf4-4cf4-bd50-af37bcded796 55154-7453 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 19820101 ANDA ANDA080154 Cardinal Health PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] E 20171231 55154-7456_37783937-1d47-4464-8744-d92216869ea1 55154-7456 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20030617 ANDA ANDA076490 Cardinal Health LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] E 20171231 55154-7460_85559e41-40df-4dc3-8d81-41282172d0f5 55154-7460 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION, SOLUTION INTRAVENOUS 20070530 ANDA ANDA077761 Cardinal Health METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-7461_7317e374-847a-4b8a-851d-467a0bb9c77e 55154-7461 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium INJECTION INTRAVENOUS 20061001 ANDA ANDA040573 Cardinal Health PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 55154-7463_a89fce39-408a-41f2-ac59-f459fddd1d9f 55154-7463 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010918 ANDA ANDA065047 Cardinal Health CEFAZOLIN SODIUM 330 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55154-7464_7317e374-847a-4b8a-851d-467a0bb9c77e 55154-7464 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin INJECTION INTRAVENOUS 20061001 ANDA ANDA040573 Cardinal Health PHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 55154-7469_1cd187eb-65d8-4f38-86e9-c4c5f23cc781 55154-7469 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 Cardinal Health DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 55154-7474_0d4a37e0-8d3b-4b70-8a13-0f7d97732e6e 55154-7474 HUMAN PRESCRIPTION DRUG Flumazenil flumazenil INJECTION, SOLUTION INTRAVENOUS 20070101 ANDA ANDA078527 Cardinal Health FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 55154-7475_65688bed-0d70-4b51-8301-1948b1deade1 55154-7475 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20110921 ANDA ANDA090963 Cardinal Health GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 55154-7476_cf9579c1-e31f-4cca-a7bc-2ba1c986cff8 55154-7476 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080110 ANDA ANDA065342 Cardinal Health CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 55154-7552_10570b57-f003-402c-a95e-c4e7199fc8cf 55154-7552 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100507 ANDA ANDA075511 Cardinal Health FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 55154-7553_381d7465-b8c2-4c1e-9874-eaac322129d7 55154-7553 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20090629 ANDA ANDA040419 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 55154-7554_e34af813-d00d-441f-a4b2-c646514da74e 55154-7554 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040400 Cardinal Health HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 55154-7555_e34af813-d00d-441f-a4b2-c646514da74e 55154-7555 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040409 Cardinal Health HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 55154-7566_e168260c-fcb5-40dc-89d9-ce2a696525e0 55154-7566 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20101201 ANDA ANDA076077 Cardinal Health FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 55154-7626_c2a8c354-2d0e-4be9-89e7-0cdb09c20f7e 55154-7626 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20140314 ANDA ANDA202871 Cardinal Health METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55154-7628_d342384b-24fe-4481-b561-68d2bf2c925f 55154-7628 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20141031 ANDA ANDA090548 Cardinal Health ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55154-7629_8581e796-584f-411f-b726-8ac3e44c52e5 55154-7629 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20070419 ANDA ANDA075677 Cardinal Health ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55154-7630_62bd1f2c-76be-4569-bfb2-8c75cc4dd97c 55154-7630 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Cardinal Health ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55154-7632_701941f1-9f55-4d28-b5a2-922a5574ae1d 55154-7632 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride 10 mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20140615 ANDA ANDA201724 Cardinal Health DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 55154-7634_3fda9030-855f-4532-b534-f1ce0b71c1c5 55154-7634 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20150601 ANDA ANDA090074 Cardinal Health PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55154-7635_72d05318-f261-4551-8d07-68e0b144bcce 55154-7635 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20150715 ANDA ANDA078220 Cardinal Health BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 55154-7636_6f83afff-b107-4ba6-8744-31be0c49817c 55154-7636 HUMAN OTC DRUG DOK Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM 100 mg/1 N 20181231 55154-7637_48a6da2c-f93b-4fc3-af10-51e93355b2ee 55154-7637 HUMAN PRESCRIPTION DRUG Memantine Memantine TABLET ORAL 20150720 ANDA ANDA090048 Cardinal Health MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 55154-7638_28e0fe7f-ad0b-4f5d-bf52-04471cc6f222 55154-7638 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA091576 Cardinal Health MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 55154-7639_48442939-b247-43f1-a31b-517532125625 55154-7639 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150615 ANDA ANDA075994 Cardinal Health LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-7640_ffbc7962-576e-4fef-b906-72f0b26f3cc3 55154-7640 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130811 ANDA ANDA090070 Cardinal Health DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55154-7641_9cd75a51-01b9-4c5b-9307-93e9e242ad63 55154-7641 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150615 ANDA ANDA075994 Cardinal Health LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55154-7642_3bcf9752-4944-44d2-8eeb-fd015745ddac 55154-7642 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Cardinal Health TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 55154-7643_d711a742-b8ab-4e43-9bd4-ce00bfc5b256 55154-7643 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 20010124 OTC MONOGRAPH NOT FINAL part334 Cardinal Health SENNOSIDES A AND B 8.6 mg/1 N 20191231 55154-7644_3bcf9752-4944-44d2-8eeb-fd015745ddac 55154-7644 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071258 Cardinal Health TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 55154-7645_fbf9b3ed-2c98-4fe5-b7de-53153eadded1 55154-7645 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150625 ANDA ANDA204197 Cardinal Health CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55154-7646_fbf9b3ed-2c98-4fe5-b7de-53153eadded1 55154-7646 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150625 ANDA ANDA204197 Cardinal Health CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55154-7647_b150d8e7-5334-47fa-90e5-377d6d4c26a1 55154-7647 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090731 ANDA ANDA078858 Cardinal Health LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55154-7648_1b819850-1ca0-4c04-88ee-fa671aa514be 55154-7648 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 ANDA ANDA077380 Cardinal Health QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 55154-7649_3238357c-a020-434c-810f-887daef03205 55154-7649 HUMAN PRESCRIPTION DRUG tamsulosin hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20150105 ANDA ANDA078015 Cardinal Health TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55154-7676_2e74f073-20b0-46fb-8d97-4d6895deeada 55154-7676 HUMAN PRESCRIPTION DRUG Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate TABLET ORAL 20120628 UNAPPROVED DRUG OTHER Cardinal Health SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 852; 155; 130 mg/1; mg/1; mg/1 E 20171231 55154-7701_2114513c-8211-41ec-942e-494d04f9d35a 55154-7701 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 55154-7702_2114513c-8211-41ec-942e-494d04f9d35a 55154-7702 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 55154-7703_2114513c-8211-41ec-942e-494d04f9d35a 55154-7703 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 55154-7704_2114513c-8211-41ec-942e-494d04f9d35a 55154-7704 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 55154-7706_2114513c-8211-41ec-942e-494d04f9d35a 55154-7706 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 55154-7707_2114513c-8211-41ec-942e-494d04f9d35a 55154-7707 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 55154-7716_2114513c-8211-41ec-942e-494d04f9d35a 55154-7716 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 55154-7717_2114513c-8211-41ec-942e-494d04f9d35a 55154-7717 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Cardinal Health WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 55154-7750_d7038a81-a9b9-4cc0-aafb-14e8eb608360 55154-7750 HUMAN PRESCRIPTION DRUG phoslo Calcium Acetate CAPSULE ORAL 20010402 NDA NDA021160 Cardinal Health CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 55154-7776_5deaa86e-993d-4af9-9494-5a0de95e8291 55154-7776 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20090327 NDA NDA021282 Cardinal Health GUAIFENESIN 600 mg/1 E 20171231 55154-7777_d9b75ff0-0fe3-4d4b-976e-42bc3e4c4766 55154-7777 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20100722 NDA NDA021282 Cardinal Health GUAIFENESIN 600 mg/1 N 20181231 55154-7825_850a893d-934d-46d6-aab6-ee093e0bfc96 55154-7825 HUMAN PRESCRIPTION DRUG Meropenem MEROPENEM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100623 ANDA ANDA090940 Cardinal Health MEROPENEM 1 g/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] E 20171231 55154-7826_e2213730-801d-4343-ac41-468d2b9eb434 55154-7826 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090324 ANDA ANDA065226 Cardinal Health CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55154-7828_b078d825-2036-4637-b093-dbda9eaedaa3 55154-7828 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN INJECTION, SOLUTION INTRAVENOUS 20080318 ANDA ANDA077753 Cardinal Health CIPROFLOXACIN 2 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 55154-7829_ded6ca36-2d29-4084-aced-5f583761cf54 55154-7829 HUMAN PRESCRIPTION DRUG Neut Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20050822 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE .2 g/5mL N 20191231 55154-7829_f702fe4d-c82f-4cc9-b7ba-c59782ac8757 55154-7829 HUMAN PRESCRIPTION DRUG Neut Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20050822 UNAPPROVED DRUG OTHER Cardinal Health SODIUM BICARBONATE .2 g/5mL N 20191231 55154-7830_6aec1e63-f324-40f4-9b9b-8146cc772592 55154-7830 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131119 NDA NDA018667 Cardinal Health FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55154-7831_b2dd1a7e-69ca-4551-b16f-9fd1a4f2bb19 55154-7831 HUMAN PRESCRIPTION DRUG MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050803 ANDA ANDA075857 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55154-7850_5bbe87b1-1c00-489a-adda-2fef463eac6a 55154-7850 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 Cardinal Health ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 55154-7875_7a4e06b0-5023-4390-83b0-366340b07db6 55154-7875 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20150625 ANDA ANDA076658 Cardinal Health FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 55154-7876_72d05318-f261-4551-8d07-68e0b144bcce 55154-7876 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20150715 ANDA ANDA077241 Cardinal Health BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 55154-7878_321300f8-d1b6-464e-9011-0fb379992ce4 55154-7878 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Cardinal Health DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55154-8104_6800dc1a-a82f-43a2-9ea0-571fe4675271 55154-8104 HUMAN PRESCRIPTION DRUG Multaq Dronedarone TABLET, FILM COATED ORAL 20090701 NDA NDA022425 Cardinal Health DRONEDARONE 400 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55154-8251_d84912c1-d947-406f-9a8a-df1ff5517b2b 55154-8251 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20091029 ANDA ANDA075765 Cardinal Health CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 55154-8252_2253b585-ef8c-474f-9ee1-29624645aaff 55154-8252 HUMAN PRESCRIPTION DRUG Nystatin Nystatin TABLET, FILM COATED ORAL 19840116 ANDA ANDA062506 Cardinal Health NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 55154-8264_07bc36d5-f62a-4e7c-b652-e9a1e22e802e 55154-8264 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 Cardinal Health KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 55154-8274_f7a1e7e9-8f82-4d68-a33f-c8beaf14d43f 55154-8274 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20091222 ANDA ANDA076388 Cardinal Health LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55154-8275_f7a1e7e9-8f82-4d68-a33f-c8beaf14d43f 55154-8275 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20091222 ANDA ANDA076388 Cardinal Health LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55154-8277_cc16fdd6-d72c-4922-942b-7962fe8f361c 55154-8277 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20111118 ANDA ANDA061926 Cardinal Health AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 55154-8278_cc16fdd6-d72c-4922-942b-7962fe8f361c 55154-8278 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20111118 ANDA ANDA061926 Cardinal Health AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 55154-8281_d84912c1-d947-406f-9a8a-df1ff5517b2b 55154-8281 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20091029 ANDA ANDA075765 Cardinal Health CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 55154-8284_62c24698-93b9-44f4-bdc4-19737d2c5cc8 55154-8284 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20101214 ANDA ANDA075551 Cardinal Health LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 55154-8285_69662e12-4f2e-401d-aed7-ada397e4ffec 55154-8285 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20100212 ANDA ANDA074949 Cardinal Health CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20191231 55154-8287_8e49409b-6bb1-4b8a-8a5b-4cb1a291660e 55154-8287 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20110218 ANDA ANDA077027 Cardinal Health CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] E 20171231 55154-8289_8323edbd-906f-4189-a169-d575fa4784f1 55154-8289 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19920501 ANDA ANDA063011 Cardinal Health MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 55154-8294_51b79b76-9598-4490-b064-9c85ee2f18b2 55154-8294 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20111207 ANDA ANDA074578 Cardinal Health ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 55154-8295_51b79b76-9598-4490-b064-9c85ee2f18b2 55154-8295 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 Cardinal Health ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 55154-8298_31cb83ae-4057-47bd-b696-240d5aad4aa7 55154-8298 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120217 ANDA ANDA077243 Cardinal Health OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-8299_31cb83ae-4057-47bd-b696-240d5aad4aa7 55154-8299 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120217 ANDA ANDA077243 Cardinal Health OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 55154-8329_34e18d6d-1214-4f3c-88ea-e797e48bc262 55154-8329 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20121221 ANDA ANDA202600 Cardinal Health ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 55154-8335_5127517f-b8d0-4af1-8a2f-5225719600bc 55154-8335 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Cardinal Health MIRTAZAPINE 15 mg/1 N 20181231 55154-8375_7638d6c0-6fcf-46ed-a829-599ed9700b92 55154-8375 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060701 ANDA ANDA077944 Cardinal Health MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 55154-8509_b918c688-5101-47e8-a318-21d66e765256 55154-8509 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 19970110 ANDA ANDA074755 Cardinal Health IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 55154-8606_f50b167c-9ed5-4c01-ab50-d8e823d53ad3 55154-8606 HUMAN OTC DRUG Simethicone Simethicone TABLET, CHEWABLE ORAL 20110603 UNAPPROVED DRUG OTHER Cardinal Health DIMETHICONE 80 mg/1 E 20171231 55154-8607_af5a98bd-bfb4-4369-bb04-64453d56cf68 55154-8607 HUMAN PRESCRIPTION DRUG ASACOL mesalamine TABLET, DELAYED RELEASE ORAL 19920401 NDA NDA019651 Cardinal Health MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 55154-8705_23b73332-cbb3-4155-8ad8-b24619cdea85 55154-8705 HUMAN PRESCRIPTION DRUG Prograf Tacrolimus CAPSULE, GELATIN COATED ORAL 19940408 NDA NDA050708 Cardinal Health TACROLIMUS ANHYDROUS 1 mg/1 E 20171231 55154-8710_62b15c2f-d6e8-4100-8d22-b4ce70e9f412 55154-8710 HUMAN PRESCRIPTION DRUG Adenocard adenosine SOLUTION INTRAVENOUS 19891030 20190131 NDA NDA019937 Cardinal Health ADENOSINE 6 mg/2mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20191231 55154-8711_d02f448c-cf55-4cea-8971-1f0ddc1222c5 55154-8711 HUMAN PRESCRIPTION DRUG Adenocard adenosine SOLUTION INTRAVENOUS 19891030 NDA NDA019937 Cardinal Health ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] E 20171231 55154-8712_aaaf3bea-1b21-4edf-9300-b7159ea9ede8 55154-8712 HUMAN PRESCRIPTION DRUG Myrbetriq mirabegron TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120628 NDA NDA202611 Cardinal Health MIRABEGRON 25 mg/1 beta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 55154-8713_aaaf3bea-1b21-4edf-9300-b7159ea9ede8 55154-8713 HUMAN PRESCRIPTION DRUG Myrbetriq mirabegron TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120628 NDA NDA202611 Cardinal Health MIRABEGRON 50 mg/1 beta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 55154-8850_cea308d4-6636-4640-ad46-f15aba82abe5 55154-8850 HUMAN OTC DRUG Acephen Acetaminophen SUPPOSITORY RECTAL 20110606 ANDA ANDA072237 Cardinal Health ACETAMINOPHEN 650 mg/1 N 20181231 55154-8851_906de72b-cc65-4020-a799-6ef16ccb6a79 55154-8851 HUMAN OTC DRUG Bisac-Evac Bisacodyl SUPPOSITORY RECTAL 20110606 OTC MONOGRAPH NOT FINAL part334 Cardinal Health BISACODYL 10 mg/1 N 20181231 55154-9352_7b863404-4dbe-4840-acb1-73b267792c27 55154-9352 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAVENOUS 20000810 ANDA ANDA088912 Cardinal Health SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 55154-9354_0f7aa2c8-0d50-4ffe-aca2-a9daf54e698a 55154-9354 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Cardinal Health HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20191231 55154-9356_292cb40b-6e37-45c4-805b-e4932b55baad 55154-9356 HUMAN PRESCRIPTION DRUG Oxytocin OXYTOCIN INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000810 NDA NDA018248 Cardinal Health OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] E 20171231 55154-9357_40c71f09-68df-4fa2-92a5-aa43f33522c4 55154-9357 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAVENOUS 20000810 ANDA ANDA088912 Cardinal Health SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 55154-9358_8f958d36-0090-4bdc-80a1-67e438e3095d 55154-9358 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000808 NDA NDA019316 Cardinal Health MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 55154-9359_0f7aa2c8-0d50-4ffe-aca2-a9daf54e698a 55154-9359 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Cardinal Health HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20191231 55154-9360_0f7aa2c8-0d50-4ffe-aca2-a9daf54e698a 55154-9360 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Cardinal Health HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20191231 55154-9363_d526d0dd-516c-4228-bed2-0aaaa2d311f5 55154-9363 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20020528 ANDA ANDA040466 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 55154-9364_68d44864-fc1a-4c44-83de-4f9a99fe9f88 55154-9364 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000907 ANDA ANDA084916 Cardinal Health DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 55154-9366_7f661df6-9338-468e-b46d-7c4fb188e317 55154-9366 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20010905 ANDA ANDA075784 Cardinal Health KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 55154-9367_505ebaae-d040-46a5-a51f-4ec8471073c3 55154-9367 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride HYDRALAZINE HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110131 ANDA ANDA040388 Cardinal Health HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 55154-9368_bf443f2d-56fd-4e8b-9ce1-6ea9992622c6 55154-9368 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20001018 ANDA ANDA075784 Cardinal Health KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 55154-9371_311a33ea-fdd7-4c19-b617-2e6450b60aad 55154-9371 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20030529 ANDA ANDA040491 Cardinal Health DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 55154-9372_e26e67d1-e2c4-495d-8525-c5f06d36ee85 55154-9372 HUMAN PRESCRIPTION DRUG Thiamine THIAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000901 ANDA ANDA080556 Cardinal Health THIAMINE HYDROCHLORIDE 100 mg/mL N 20181231 55154-9373_0f7aa2c8-0d50-4ffe-aca2-a9daf54e698a 55154-9373 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Cardinal Health HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20191231 55154-9375_183ca97a-921c-456e-9db4-48f56069a059 55154-9375 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20001018 ANDA ANDA075784 Cardinal Health KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 55154-9376_faa12ba9-072d-465e-9753-4ab4f1e3b6c6 55154-9376 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041129 ANDA ANDA062366 Cardinal Health GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 55154-9378_f0ca8550-6179-495a-98d1-e7858d24230f 55154-9378 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100527 ANDA ANDA080404 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 55154-9382_d1e4f7f4-a824-4924-a71b-e8d136076cbc 55154-9382 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060320 ANDA ANDA065179 Cardinal Health AZITHROMYCIN MONOHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 55154-9383_13919bfe-eaa5-4039-b270-9eeff067e45e 55154-9383 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA040583 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 55154-9385_150cbd48-d550-42f4-bb35-131e0b47c5be 55154-9385 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091210 ANDA ANDA065179 Cardinal Health AZITHROMYCIN MONOHYDRATE 100 mg/mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 55154-9386_7b687747-bf51-4366-9277-29bc82fc665a 55154-9386 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110531 ANDA ANDA065523 Cardinal Health PIPERACILLIN; TAZOBACTAM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 55154-9388_34881c59-5ef6-46e6-ad0a-2f3dcf7db39a 55154-9388 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 55154-9389_54c52410-ab99-48a9-becc-c65a4075705d 55154-9389 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin Imipenem and Cilastatin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120103 ANDA ANDA090577 Cardinal Health IMIPENEM; CILASTATIN SODIUM 500; 500 mg/1; mg/1 Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] E 20171231 55154-9390_09672124-12d2-48f0-af1f-d9ca048e5b53 55154-9390 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20000905 NDA NDA017584 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 55154-9391_4489f806-e680-4ef3-910d-3e6e3037dd50 55154-9391 HUMAN PRESCRIPTION DRUG Protamine Sulfate PROTAMINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20001018 ANDA ANDA089454 Cardinal Health PROTAMINE SULFATE 10 mg/mL Heparin Binding Activity [MoA],Heparin Reversal Agent [EPC],Reversed Anticoagulation Activity [PE] E 20171231 55154-9392_0f7aa2c8-0d50-4ffe-aca2-a9daf54e698a 55154-9392 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Cardinal Health HEPARIN SODIUM 5000 [USP'U]/.5mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20191231 55154-9393_959203df-fea9-4af8-8168-d006828e589e 55154-9393 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 Cardinal Health MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-9395_a4d1d5b7-92b0-4448-a9b7-1d951e11d4f7 55154-9395 HUMAN PRESCRIPTION DRUG Bacteriostatic Sodium Chloride SODIUM CHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000808 ANDA ANDA088911 Cardinal Health SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 55154-9396_0af6eac6-7434-4272-ab5f-a17fb3566e46 55154-9396 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 55154-9397_fa9ce0ff-ef2c-4ae9-b43e-88f34ec03bb5 55154-9397 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20090812 NDA NDA017029 Cardinal Health HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20191231 55154-9398_f3607393-0ca2-4a59-aef8-ffb814e0e36f 55154-9398 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20001018 ANDA ANDA075784 Cardinal Health KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 55154-9399_898b614c-b374-41af-871f-9442e59e5046 55154-9399 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20150220 NDA AUTHORIZED GENERIC NDA020164 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-9401_7423e112-ea8c-42cb-a3b8-64f53e4c7f50 55154-9401 HUMAN OTC DRUG Docusate Sodium Docusate Sodium LIQUID ORAL 19830216 OTC MONOGRAPH NOT FINAL part334 Cardinal Health DOCUSATE SODIUM 100 mg/10mL N 20181231 55154-9403_6942eb20-2fa6-4355-b2e0-ddc26807678b 55154-9403 HUMAN OTC DRUG Milk of Magnesia Milk of Magnesia SUSPENSION ORAL 20110607 OTC MONOGRAPH FINAL part331 Cardinal Health MAGNESIUM HYDROXIDE 2400 mg/30mL N 20181231 55154-9405_67a7293e-1b9a-43d3-a696-cef473f34504 55154-9405 HUMAN OTC DRUG Acetaminophen Acetaminophen SOLUTION ORAL 20110602 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL E 20171231 55154-9409_74f72ca1-b5a8-4178-af61-503ee48331fd 55154-9409 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride ELIXIR ORAL 19820210 ANDA ANDA087513 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/10mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 55154-9410_fc90d0cd-35e5-4b6f-ad4f-c69e2d23adb3 55154-9410 HUMAN PRESCRIPTION DRUG Sodium Citrate and Citric Acid SODIUM CITRATE and CITRIC ACID MONOHYDRATE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Cardinal Health SODIUM CITRATE, UNSPECIFIED FORM; CITRIC ACID MONOHYDRATE 500; 334 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 55154-9412_9d965e32-b78d-4294-b244-fa56251e75fd 55154-9412 HUMAN OTC DRUG Milk of Magnesia Milk of Magnesia SUSPENSION ORAL 20110607 OTC MONOGRAPH FINAL part331 Cardinal Health MAGNESIUM HYDROXIDE 2400 mg/10mL N 20191231 55154-9415_f186718f-54e6-4163-a447-cae9cc7d3f41 55154-9415 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 20110610 ANDA ANDA087508 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV E 20171231 55154-9417_918cb5de-c687-43c8-b54a-439497a8e4da 55154-9417 HUMAN OTC DRUG Acetaminophen Oral Solution Acetaminophen LIQUID ORAL 20110602 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 325 mg/10.15mL E 20171231 55154-9418_f7e8b74b-512c-4230-9a82-5fd4b22d7836 55154-9418 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride ELIXIR ORAL 19820210 ANDA ANDA087513 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 55154-9419_8e07723d-96b4-487e-899e-a1458edceeeb 55154-9419 HUMAN PRESCRIPTION DRUG Sodium Citrate and Citric Acid SODIUM CITRATE and CITRIC ACID MONOHYDRATE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Cardinal Health SODIUM CITRATE; CITRIC ACID MONOHYDRATE 500; 334 mg/5mL; mg/5mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 55154-9420_360e925d-7ba2-4180-bc79-c7b2a44df0a8 55154-9420 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Guaifenesin and Dextromethorphan SYRUP ORAL 19920701 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 200; 20 mg/10mL; mg/10mL E 20171231 55154-9422_688b74ba-732a-4b89-87c2-447d1a139750 55154-9422 HUMAN OTC DRUG Mag-Al Plus XS Magnesium Hydroxide, Aluminum Hydroxide, Simethicone SUSPENSION ORAL 20110607 OTC MONOGRAPH FINAL part331 Cardinal Health MAGNESIUM HYDROXIDE; ALUMINUM HYDROXIDE; DIMETHICONE 2400; 2400; 240 mg/30mL; mg/30mL; mg/30mL N 20181231 55154-9425_9253cc84-814b-43f4-9b86-fecd3de4d792 55154-9425 HUMAN OTC DRUG Guaifenesin Guaifenesin LIQUID ORAL 20110602 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 200 mg/10mL E 20171231 55154-9426_5caa39e5-b003-4fa6-8731-09bfa00a0019 55154-9426 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19960730 20180930 ANDA ANDA074623 Cardinal Health LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20191231 55154-9427_bec1edc8-c011-4f42-b67b-b8c681d870ee 55154-9427 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride SOLUTION ORAL 19910601 ANDA ANDA072744 Cardinal Health METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 55154-9429_6ecb1654-6a37-4a08-98a8-d2d8c8530283 55154-9429 HUMAN OTC DRUG Mag-Al Plus Magnesium Hydroxide, Aluminum Hydroxide, Simethicone SUSPENSION ORAL 20110607 OTC MONOGRAPH FINAL part331 Cardinal Health MAGNESIUM HYDROXIDE; ALUMINUM HYDROXIDE; DIMETHICONE 1200; 1200; 120 mg/30mL; mg/30mL; mg/30mL N 20181231 55154-9430_a759ad0f-2712-4927-a8d0-60708aa604a8 55154-9430 HUMAN PRESCRIPTION DRUG Valproic Acid VALPROIC ACID SOLUTION ORAL 20050411 ANDA ANDA075379 Cardinal Health VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 55154-9431_56e5f712-1920-47cb-bfda-ae3598a46927 55154-9431 HUMAN OTC DRUG Mag-Al Magnesium Hydroxide, Aluminum Hydroxide LIQUID ORAL 20110607 OTC MONOGRAPH FINAL part331 Cardinal Health MAGNESIUM HYDROXIDE; ALUMINUM HYDROXIDE 1200; 1200 mg/30mL; mg/30mL E 20171231 55154-9432_fba2c77b-6418-4acb-b193-186442baeca1 55154-9432 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate SUSPENSION ORAL 20091119 NDA NDA019183 Cardinal Health SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] E 20171231 55154-9433_0d68c9e8-5402-480b-84e8-dd5036e157c8 55154-9433 HUMAN OTC DRUG Acetaminophen Oral Solution Acetaminophen LIQUID ORAL 20110602 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL E 20171231 55154-9434_b459483f-4c91-47fe-b34b-d413cd28dc62 55154-9434 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Cardinal Health POTASSIUM CHLORIDE 1.5 g/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 55154-9436_2c9499fb-e3e7-4984-ac1e-168c7b3804bd 55154-9436 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20090601 ANDA ANDA062512 Cardinal Health NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 55154-9437_bf2e3775-0a2a-4a35-87c4-8f08a3080b23 55154-9437 HUMAN OTC DRUG Guaifenesin Guaifenesin SOLUTION ORAL 20110602 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 100 mg/5mL N 20191231 55154-9438_a1b08548-2d90-45a4-b523-be65b1666f95 55154-9438 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090920 ANDA ANDA079120 Cardinal Health LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-9439_2b3bbf81-e768-4e42-868a-c6ce4198e6be 55154-9439 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN; CODEINE PHOSPHATE 100; 10 mg/5mL; mg/5mL CV E 20171231 55154-9440_1957ffd0-2255-4429-a255-db4232a6175f 55154-9440 HUMAN PRESCRIPTION DRUG Megestrol Acetate MEGESTROL ACETATE SUSPENSION ORAL 20060707 20180630 ANDA ANDA076721 Cardinal Health MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20191231 55154-9441_f199e290-6c5e-48b9-b88d-b74e769c3f41 55154-9441 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE SOLUTION ORAL 19690101 UNAPPROVED DRUG OTHER Cardinal Health POTASSIUM CHLORIDE 1.5 g/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 55154-9442_2abec441-3eac-4c0e-a05a-369a1ef0e51f 55154-9442 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 20110610 ANDA ANDA087508 Cardinal Health ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV E 20171231 55154-9443_82d80af5-aadd-4d27-afbd-ab2dafaa894f 55154-9443 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 19660730 ANDA ANDA074623 Cardinal Health LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 55154-9444_9d31380b-c683-4f4f-ad9a-e3e31e62383c 55154-9444 HUMAN PRESCRIPTION DRUG AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE SOLUTION ORAL 19950717 ANDA ANDA074509 Cardinal Health AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20191231 55154-9446_2021df3c-ae99-4fda-b096-40c75c5c80b2 55154-9446 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Guaifenesin and Dextromethorphan SYRUP ORAL 19920701 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL E 20171231 55154-9447_d9be1743-d8ed-4d02-aa3b-5d725e017cce 55154-9447 HUMAN PRESCRIPTION DRUG Levetiracetam LEVETIRACETAM SOLUTION ORAL 20150604 ANDA ANDA201157 Cardinal Health LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55154-9448_eca4a38d-2c17-41f0-902a-dbd0e848223a 55154-9448 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 19660730 ANDA ANDA074623 Cardinal Health LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 55154-9449_0ad65802-c418-4f16-a083-3105e34566a8 55154-9449 HUMAN OTC DRUG Acetaminophen Acetaminophen SOLUTION ORAL 20070801 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/5mL N 20181231 55154-9525_3f0f17e1-a96b-4f45-8dcf-95a2065c532e 55154-9525 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111017 ANDA ANDA078034 Cardinal Health SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 55154-9552_df42df85-1ce1-41e8-876f-40d4a8c8b67d 55154-9552 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19820304 ANDA ANDA062356 Cardinal Health GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 55154-9553_317cc115-d955-4de8-aab7-6d7359728a7c 55154-9553 HUMAN PRESCRIPTION DRUG Haloperidol HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20101215 ANDA ANDA075689 Cardinal Health HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20181231 55154-9554_8c7172b2-b81f-4428-a97f-97c0e9c58fed 55154-9554 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride HYDRALAZINE HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20110131 ANDA ANDA040388 Cardinal Health HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 55154-9557_13919bfe-eaa5-4039-b270-9eeff067e45e 55154-9557 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA040583 Cardinal Health METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 55154-9559_acd456a9-3bb0-4e53-83fc-76c704ca1cb8 55154-9559 HUMAN PRESCRIPTION DRUG CEFAZOLIN CEFAZOLIN SODIUM POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110715 ANDA ANDA065303 Cardinal Health CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 55154-9560_20fcbb57-edde-4f6c-adf3-0d3a23c8f543 55154-9560 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 55154-9562_959203df-fea9-4af8-8168-d006828e589e 55154-9562 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 Cardinal Health MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55154-9563_0a2b5eed-aa92-485a-95d4-650a1c60a80f 55154-9563 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 55154-9564_f990dd6b-cb73-41a2-a560-1978f324b9c0 55154-9564 HUMAN PRESCRIPTION DRUG SENSORCAINE MPF BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; RETROBULBAR 20101119 NDA NDA018304 Cardinal Health BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 7.5; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 55154-9565_0a2b5eed-aa92-485a-95d4-650a1c60a80f 55154-9565 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 5; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 55154-9566_34881c59-5ef6-46e6-ad0a-2f3dcf7db39a 55154-9566 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 10; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 55154-9567_34881c59-5ef6-46e6-ad0a-2f3dcf7db39a 55154-9567 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 55154-9568_34881c59-5ef6-46e6-ad0a-2f3dcf7db39a 55154-9568 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 20; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 55154-9569_34881c59-5ef6-46e6-ad0a-2f3dcf7db39a 55154-9569 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 55154-9572_34881c59-5ef6-46e6-ad0a-2f3dcf7db39a 55154-9572 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 55154-9573_0601f5f0-20b6-4c03-8064-51274ae83bef 55154-9573 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 55154-9574_a96cd278-aaff-4865-abd6-ebac83daf079 55154-9574 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 55154-9575_0af6eac6-7434-4272-ab5f-a17fb3566e46 55154-9575 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20100812 NDA NDA006488 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 10; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 55154-9576_8c42ae9f-4ae0-4063-a97c-8c68b9926ebe 55154-9576 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20150220 NDA AUTHORIZED GENERIC NDA020164 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-9577_7237d91c-ae08-45ca-9319-78f1446ee8fb 55154-9577 HUMAN PRESCRIPTION DRUG Oxytocin OXYTOCIN INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000810 NDA NDA018248 Cardinal Health OXYTOCIN 10 [USP'U]/mL Increased Uterine Smooth Muscle Contraction or Tone [PE],Oxytocic [EPC],Oxytocin [Chemical/Ingredient] N 20181231 55154-9578_13185726-651b-45ed-9b4f-f09aac26339e 55154-9578 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20150220 NDA AUTHORIZED GENERIC NDA020164 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-9579_40d6fdbd-71db-4930-b275-c84008698073 55154-9579 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20150220 NDA AUTHORIZED GENERIC NDA020164 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-9580_21d9bc55-0f94-42d5-8295-a1e057af10c6 55154-9580 HUMAN PRESCRIPTION DRUG Enoxaparin sodium enoxaparin sodium INJECTION SUBCUTANEOUS 20150220 NDA AUTHORIZED GENERIC NDA020164 Cardinal Health ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 55154-9605_d4fb2aab-1116-4854-b567-e7d951fdf641 55154-9605 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20100819 NDA NDA021153 Cardinal Health ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 55154-9606_d4fb2aab-1116-4854-b567-e7d951fdf641 55154-9606 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20100819 NDA NDA021153 Cardinal Health ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 55154-9607_b2adbf5d-dccd-41ff-9f12-4e606ccb541f 55154-9607 HUMAN PRESCRIPTION DRUG XYLOCAINE Lidocaine hydrochloride JELLY TOPICAL 20120716 NDA NDA008816 Cardinal Health LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 55154-9608_4dd325bb-58b9-4126-8662-63f680c26bf2 55154-9608 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20100510 NDA NDA019962 Cardinal Health METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-9609_4dd325bb-58b9-4126-8662-63f680c26bf2 55154-9609 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20100510 NDA NDA019962 Cardinal Health METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55154-9613_14355f76-caa3-4c12-957a-9605e5c0f09c 55154-9613 HUMAN PRESCRIPTION DRUG PULMICORT RESPULES Budesonide SUSPENSION RESPIRATORY (INHALATION) 20091120 NDA NDA020929 Cardinal Health BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 55154-9614_d4fb2aab-1116-4854-b567-e7d951fdf641 55154-9614 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20070319 NDA NDA021957 Cardinal Health ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 55154-9615_dce12085-d6c4-48a5-959b-e771c413c9c5 55154-9615 HUMAN PRESCRIPTION DRUG NEXIUM I.V. Esomeprazole sodium INJECTION INTRAVENOUS 20050503 NDA NDA021689 Cardinal Health ESOMEPRAZOLE SODIUM 40 mg/5mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 55154-9616_2d4fa32e-a74d-4507-849a-c16da6329361 55154-9616 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 Cardinal Health ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 55154-9618_a0675665-555a-42c4-94d7-891c7c9742a8 55154-9618 HUMAN PRESCRIPTION DRUG BRILINTA Ticagrelor TABLET ORAL 20110805 NDA NDA022433 Cardinal Health TICAGRELOR 90 mg/1 P2Y12 Platelet Inhibitor [EPC],Phenylalanine Hydroxylase Activators [MoA],Decreased Platelet Aggregation [PE],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55154-9625_81185f31-9f66-4344-acf1-f056f7cf06f8 55154-9625 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 19960507 20190531 ANDA ANDA074356 Cardinal Health CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 55154-9626_063bb0bd-a9f2-4036-a52c-9f693e9dd3b6 55154-9626 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 Cardinal Health LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 55154-9668_e11652b8-6ce6-4366-9519-a43a0d36f235 55154-9668 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 Cardinal Health AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 55154-9726_664a1b34-08c8-47e2-b54a-c3af899f2c98 55154-9726 HUMAN PRESCRIPTION DRUG Renagel sevelamer hydrochloride TABLET ORAL 20080606 NDA NDA021179 Cardinal Health SEVELAMER HYDROCHLORIDE 400 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] E 20171231 55154-9727_664a1b34-08c8-47e2-b54a-c3af899f2c98 55154-9727 HUMAN PRESCRIPTION DRUG Renagel sevelamer hydrochloride TABLET ORAL 20080606 NDA NDA021179 Cardinal Health SEVELAMER HYDROCHLORIDE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] E 20171231 55154-9728_d5e0d75f-5d81-4c05-85ee-71b4651773bf 55154-9728 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20090812 NDA NDA022127 Cardinal Health SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] E 20171231 55154-9752_a44c98e6-4d9d-4831-b7eb-6522e12bca5b 55154-9752 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20110603 NDA NDA021375 Cardinal Health LORATADINE 10 mg/1 E 20171231 55165-0104_5dfdc506-d989-47aa-8104-23b7421d1e4b 55165-0104 HUMAN OTC DRUG SPF-30 SPORT moisturizer Zinc Oxide LOTION TOPICAL 20120603 OTC MONOGRAPH FINAL part352 Juice Beauty ZINC OXIDE 20 g/100mL E 20171231 55221-0001_f0ea06d3-5edd-4dad-b26e-e00fe82102a3 55221-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980615 UNAPPROVED MEDICAL GAS Cox Health Home Support OXYGEN 99 L/100L E 20171231 55249-1001_c2b21fe1-ae95-4540-9367-39076ebfa93c 55249-1001 HUMAN OTC DRUG Tosowoong Mens Booster Repair Skin ARBUTIN LIQUID TOPICAL 20130705 UNAPPROVED DRUG OTHER Mantong ARBUTIN 1 mg/150mL E 20171231 55249-2001_0afa4f9a-c053-42fb-8e91-e10066d2608f 55249-2001 HUMAN OTC DRUG Tosowoong Mens Booster Repair ADENOSINE LOTION TOPICAL 20130705 UNAPPROVED DRUG OTHER Mantong ADENOSINE 1 mg/150mL E 20171231 55253-801_75a6cf80-8032-4853-bab9-6ed5342aad08 55253-801 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120329 NDA AUTHORIZED GENERIC NDA020717 CIMA LABS INC. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 55253-802_75a6cf80-8032-4853-bab9-6ed5342aad08 55253-802 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120329 NDA AUTHORIZED GENERIC NDA020717 CIMA LABS INC. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 55259-1001_33a9ab9e-74c5-441e-9821-6a3991a9987c 55259-1001 HUMAN OTC DRUG 7030 Calcium Gold CALCIUM CAPSULE ORAL 20130310 UNAPPROVED DRUG OTHER Apexel Co., Ltd CALCIUM .99 1/1 N 20181231 55259-2001_9d698942-f723-4adb-8095-760a7ad3fdd6 55259-2001 HUMAN OTC DRUG 7030 Calcium Premium CALCIUM CAPSULE ORAL 20130310 UNAPPROVED DRUG OTHER Apexel Co., Ltd CALCIUM .99 1/1 N 20181231 55259-4001_177b5794-db5b-48e5-e054-00144ff88e88 55259-4001 HUMAN OTC DRUG HANTAI 8030 Ca-D3 Premium Ostreae Concha, Calcium TABLET ORAL 20150518 UNAPPROVED DRUG OTHER APEXEL CO., LTD. CALCIUM .99 1/1 N 20181231 55259-5001_177a9290-c63d-3079-e054-00144ff88e88 55259-5001 HUMAN OTC DRUG HANTAI 8030 Ca-D3 GOLD Ostreae Concha (Calcium 99%) TABLET ORAL 20150518 UNAPPROVED DRUG OTHER APEXEL CO., LTD. CALCIUM .99 1/1 N 20181231 55264-001_a2835b9e-fe09-4698-b0e2-141706449d40 55264-001 HUMAN OTC DRUG SHOPKO HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20110208 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP. HYDROCORTISONE 1 g/100g E 20171231 55264-005_c76a92ff-2865-42d5-ac74-5ee8acba402f 55264-005 HUMAN OTC DRUG GINSENGGO Camphor, Menthol, Methyl Salicylate PATCH CUTANEOUS; TOPICAL; TRANSDERMAL 20130822 OTC MONOGRAPH NOT FINAL part348 Sinsin Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE .7; 1.4; 2.8 mg/1; mg/1; mg/1 N 20181231 55264-007_6f5d826c-182e-42b8-bd64-26b6d00320f8 55264-007 HUMAN OTC DRUG Sinsin Mulpas Camphor, Menthol, Methyl Salicylate LIQUID CUTANEOUS; TOPICAL; TRANSDERMAL 20140110 OTC MONOGRAPH NOT FINAL part348 Sinsin Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 4.5; 4.2; 6.9 mg/mL; mg/mL; mg/mL N 20181231 55264-011_d9316435-fb4b-4399-abce-05f20347dd6e 55264-011 HUMAN OTC DRUG Air Sinsin Pas Camphor, Menthol, Methyl salicylate AEROSOL, SPRAY CUTANEOUS; TOPICAL; TRANSDERMAL 20110701 OTC MONOGRAPH FINAL part348 Sinsin Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE .361; .289; .361 g/100mL; g/100mL; g/100mL N 20181231 55264-012_e578aace-529d-4307-840c-919bcdd1af3e 55264-012 HUMAN OTC DRUG SINSINPAP COOL LEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUS PATCH CUTANEOUS; TOPICAL; TRANSDERMAL 20160530 OTC MONOGRAPH NOT FINAL part348 Sinsin Pharmaceutical Co., Ltd. LEVOMENTHOL; THYMOL; CAMPHOR (SYNTHETIC); PEPPERMINT OIL; EUCALYPTUS OIL 49.4; 16.5; 82.4; 164.7; 16.5 mg/1; mg/1; mg/1; mg/1; mg/1 N 20181231 55264-020_1b205db2-6721-4dc8-a65a-2c250e3a8299 55264-020 HUMAN OTC DRUG Arex Sinsin Pas Camphor, Mentha Oil, Menthol, Methyl Salicylate, Zinc Oxide PATCH CUTANEOUS; TOPICAL; TRANSDERMAL 20150831 OTC MONOGRAPH NOT FINAL part348 Sinsin Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); PEPPERMINT OIL; LEVOMENTHOL; METHYL SALICYLATE; ZINC OXIDE 17.05; 22.73; 45.45; 45.45; 215.91 mg/1; mg/1; mg/1; mg/1; mg/1 N 20181231 55264-021_28d21f78-07ae-464b-8ac0-104b223b5640 55264-021 HUMAN OTC DRUG Arex Sinsin Pas Camphor, Mentha Oil, Menthol, Methyl Salicylate, Zinc Oxide PATCH CUTANEOUS; TOPICAL; TRANSDERMAL 20130726 OTC MONOGRAPH NOT FINAL part348 Sinsin Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); PEPPERMINT OIL; LEVOMENTHOL; METHYL SALICYLATE; ZINC OXIDE 34.1; 45.46; 90.9; 90.9; 431.82 mg/1; mg/1; mg/1; mg/1; mg/1 N 20181231 55264-050_1898cb5a-7a8a-41f4-8864-d9a7f262677a 55264-050 HUMAN OTC DRUG Scarderm Allantoin GEL TOPICAL 20160530 OTC MONOGRAPH FINAL part347 Sinsin Pharmaceutical Co., Ltd. ALLANTOIN 10 mg/g N 20181231 55264-101_f86ce624-a49b-4f2f-9703-53e26d914f5c 55264-101 HUMAN OTC DRUG SINSINPAS Pain Relieving Patch DL-Camphor, L-menthol, methyl salicylate PATCH TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 Sinsin Pharmaceutical Co., Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 5.56; 25.48; 28.1 g/459.93g; g/459.93g; g/459.93g N 20181231 55264-102_575c7c54-a53a-57b1-e053-2991aa0a39c0 55264-102 HUMAN OTC DRUG AIR SINSINPAS-EX L-menthol, Methyl salicylate, Dl-Camphor SPRAY TOPICAL 20170822 OTC MONOGRAPH NOT FINAL part348 Sinsin Pharmaceutical Co., Ltd. LEVOMENTHOL; METHYL SALICYLATE; CAMPHOR (SYNTHETIC) 6.4; 3.5; 6 g/200mL; g/200mL; g/200mL N 20181231 55264-269_50f5a131-ae2a-42b5-8889-77be126f5c16 55264-269 HUMAN OTC DRUG Medicated Heat Capsicum PATCH TOPICAL 20100520 OTC MONOGRAPH NOT FINAL part348 United Exchange Corporation CAPSAICIN .6 mg/1 N 20181231 55264-626_aa5590a2-3ac5-4924-8941-cf79826672fd 55264-626 HUMAN OTC DRUG SHOPKO TRIPLE ANTIBIOTIC PLUS BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE OINTMENT TOPICAL 20110106 OTC MONOGRAPH FINAL part333B UNITED EXCHANGE CORP. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g E 20171231 55277-1001_add50493-e2bc-4a51-b5f7-928905ed687e 55277-1001 HUMAN OTC DRUG PANCOLD S GUAIFENESIN LIQUID ORAL 20130115 OTC MONOGRAPH FINAL part341 Kafus Co., Ltd GUAIFENESIN; CAFFEINE; CHLORPHENIRAMINE; METHYLEPHEDRINE HYDROCHLORIDE, DL-; ACETAMINOPHEN 83.3; 30; 2.5; 17.5; 300 mg/30mL; mg/30mL; mg/30mL; mg/30mL; mg/30mL E 20171231 55281-010_8dec3a6b-dc64-43a0-bd23-7221b6e7542d 55281-010 HUMAN OTC DRUG misoli Shining Care Diamond Premium Gold Hydro G el Eye Glycerin PATCH TOPICAL 20161010 UNAPPROVED DRUG OTHER JT Co., Ltd. GLYCERIN .16 g/1.6g N 20181231 55281-020_e0bb55ec-accc-48ce-ad0b-a626da3d0f79 55281-020 HUMAN OTC DRUG misoli Power Snail and Collagen Hydrog el Mask Pack Adenosine PATCH TOPICAL 20161010 UNAPPROVED DRUG OTHER JT Co., Ltd. ADENOSINE .014 g/35g N 20181231 55282-1001_a7e18cae-73f6-4c8c-8be8-19c75f087af4 55282-1001 HUMAN OTC DRUG PiGe ll Real Skin Mask Pack SUS SCROFA SKIN LIQUID TOPICAL 20130114 UNAPPROVED DRUG OTHER Osung Co., Ltd SUS SCROFA SKIN 8 g/100g E 20171231 55282-2001_53f655af-53ff-46d7-a2b5-d0ea7714343d 55282-2001 HUMAN OTC DRUG PiGe ll Real Skin Neck Pack SUS SCROFA SKIN LIQUID TOPICAL 20130114 UNAPPROVED DRUG OTHER Osung Co., Ltd SUS SCROFA SKIN 8 g/100g E 20171231 55282-3001_405c1a1f-0683-4196-a98e-7ce4089417ae 55282-3001 HUMAN OTC DRUG PiGe ll Real Skin Eye SUS SCROFA SKIN PATCH TOPICAL 20130114 UNAPPROVED DRUG OTHER Osung Co., Ltd SUS SCROFA SKIN 8 g/100g E 20171231 55287-100_9cdb77bc-a883-4e1e-ac32-c2ae1af3afe6 55287-100 HUMAN OTC DRUG Green Tussin DM Guaifenesin, Dextromethorphan HBr LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Green Choice for Life GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/15mL; mg/15mL E 20171231 55287-101_8cc66bd5-78dc-409f-86a9-c9d08e3358b4 55287-101 HUMAN OTC DRUG Green Tussin SUGAR FREE DM Green Tussin SUGAR FREE DM LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part341 Green Choice for Life DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/15mL; mg/15mL E 20171231 55287-102_731e1b79-9713-43ec-9900-7a9fc5156c1b 55287-102 HUMAN OTC DRUG Green Relief Bismuth Subsalicylate LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part335 Green Choice for Life BISMUTH SUBSALICYLATE 262 mg/15mL E 20171231 55289-002_5aa942d9-654b-3f3b-e053-2991aa0aa484 55289-002 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 PD-Rx Pharmaceuticals, Inc. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 55289-005_5a96f12e-84ad-fad6-e053-2a91aa0a879f 55289-005 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 PD-Rx Pharmaceuticals, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 55289-007_5ace2a78-fac0-a635-e053-2991aa0a4ad2 55289-007 HUMAN PRESCRIPTION DRUG Trileptal oxcarbazepine TABLET, FILM COATED ORAL 20000130 NDA NDA021014 PD-Rx Pharmaceuticals, Inc. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55289-010_5aa50dba-a0c6-3124-e053-2991aa0a03e7 55289-010 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 PD-Rx Pharmaceuticals, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 55289-012_5c640d31-d86a-f05c-e053-2a91aa0a4365 55289-012 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride amantadine hydrochloride CAPSULE, GELATIN COATED ORAL 20110915 ANDA ANDA070589 PD-Rx Pharmaceuticals, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 55289-014_5aa4e817-10fa-9e58-e053-2991aa0a9cb2 55289-014 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 PD-Rx Pharmaceuticals, Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 55289-016_5aa579f9-e4f8-d251-e053-2991aa0a28d2 55289-016 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 PD-Rx Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55289-018_5aa9b4eb-cc8d-e5d5-e053-2991aa0a00a5 55289-018 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 PD-Rx Pharmaceuticals, Inc. DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55289-019_635f77cf-0064-5b21-e053-2991aa0a010d 55289-019 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19900930 ANDA ANDA061926 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 55289-020_5fb45619-3930-24c5-e053-2991aa0a2afc 55289-020 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19900930 ANDA ANDA061926 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55289-022_56df4df8-c115-1c1c-e054-00144ff88e88 55289-022 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 PD-Rx Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55289-024_5aa608e2-45b9-b95c-e053-2a91aa0a4591 55289-024 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19880225 ANDA ANDA062882 PD-Rx Pharmaceuticals, Inc. AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55289-025_5aa9b4eb-ccef-e5d5-e053-2991aa0a00a5 55289-025 HUMAN PRESCRIPTION DRUG Erythromycin Base Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55289-028_5aa8704d-aafb-62f0-e053-2991aa0a5ed2 55289-028 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 PD-Rx Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-036_5aa8fd67-9e55-de5e-e053-2991aa0a8622 55289-036 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 PD-Rx Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-037_5b4b9ea4-d846-07ab-e053-2991aa0a9850 55289-037 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 PD-Rx Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-038_5269d44f-ae74-3a34-e054-00144ff8d46c 55289-038 HUMAN PRESCRIPTION DRUG Flurazepam Hydrochloride flurazepam hydrochloride CAPSULE ORAL 19851127 ANDA ANDA070345 PD-Rx Pharmaceuticals, Inc. FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-039_5abd25d3-3db5-718f-e053-2a91aa0a0c04 55289-039 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55289-040_57851f1c-c693-7b4f-e053-2991aa0a0b9d 55289-040 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 19790605 ANDA ANDA086162 PD-Rx Pharmaceuticals, Inc. BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 55289-045_5aa50dba-a09d-3124-e053-2991aa0a03e7 55289-045 HUMAN PRESCRIPTION DRUG Albuterol albuterol sulfate TABLET ORAL 20110504 ANDA ANDA072894 PD-Rx Pharmaceuticals, Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 55289-048_5ace7fce-8db5-3e0c-e053-2991aa0aad45 55289-048 HUMAN PRESCRIPTION DRUG TYLENOL with Codeine acetaminophen and codeine phosphate TABLET ORAL 19770817 ANDA ANDA085055 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 55289-049_6365700d-dfe9-65f2-e053-2991aa0a1fba 55289-049 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19871101 ANDA ANDA087499 PD-Rx Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20191231 55289-052_5ace2a78-fa91-a635-e053-2991aa0a4ad2 55289-052 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19940126 ANDA ANDA074131 PD-Rx Pharmaceuticals, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-053_5abd475c-56c1-749a-e053-2991aa0aaeea 55289-053 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20080324 ANDA ANDA078902 PD-Rx Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-054_5ace2473-4ce9-979c-e053-2a91aa0af7db 55289-054 HUMAN PRESCRIPTION DRUG Terbinafine Terbinafine TABLET ORAL 20070730 ANDA ANDA077919 PD-Rx Pharmaceuticals, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 55289-055_5aa4f1c7-3bdc-0f62-e053-2991aa0a094e 55289-055 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720228 ANDA ANDA080212 PD-Rx Pharmaceuticals, Inc. ISONIAZID 100 mg/1 Antimycobacterial [EPC] N 20181231 55289-057_5a945df0-afe4-20fe-e053-2991aa0a1cd5 55289-057 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 19900930 ANDA ANDA062702 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55289-058_5a945df0-b014-20fe-e053-2991aa0a1cd5 55289-058 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110128 ANDA ANDA062702 PD-Rx Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55289-060_57d3cbbf-849c-b981-e053-2991aa0ab099 55289-060 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 PD-Rx Pharmaceuticals, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 55289-061_531d01ec-b56d-44d6-e054-00144ff88e88 55289-061 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19900930 ANDA ANDA083116 PD-Rx Pharmaceuticals, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-064_6440a459-b362-9290-e053-2a91aa0aa968 55289-064 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 PD-Rx Pharmaceuticals, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 55289-066_55111b53-a264-5226-e054-00144ff88e88 55289-066 HUMAN PRESCRIPTION DRUG Chlorpropamide chlorpropamide TABLET ORAL 19840601 ANDA ANDA088549 PD-Rx Pharmaceuticals, Inc. CHLORPROPAMIDE 250 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55289-067_5aa6c8c1-0f41-ade7-e053-2991aa0aac64 55289-067 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 19810226 ANDA ANDA086831 PD-Rx Pharmaceuticals, Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 55289-073_5bea90f5-b3e5-3056-e053-2a91aa0a73de 55289-073 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20090903 ANDA ANDA070317 PD-Rx Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55289-074_5aa6db46-14f5-4e42-e053-2a91aa0a38b9 55289-074 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 19870609 ANDA ANDA070317 PD-Rx Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55289-075_5c7741fb-a748-443d-e053-2991aa0a83f6 55289-075 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55289-076_5668f6e3-234e-3f94-e054-00144ff8d46c 55289-076 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55289-077_5e85c373-5605-7755-e053-2991aa0aa039 55289-077 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 19991210 NDA NDA021085 PD-Rx Pharmaceuticals, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55289-081_5510f584-ce76-411c-e054-00144ff88e88 55289-081 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070509 ANDA ANDA065368 PD-Rx Pharmaceuticals, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55289-082_5ab9407f-9737-b5a7-e053-2a91aa0a919c 55289-082 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55289-084_5ab96470-cee2-f91a-e053-2a91aa0ab279 55289-084 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55289-085_54d90668-51b4-4330-e054-00144ff88e88 55289-085 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55289-090_5a94588a-e4de-20fc-e053-2991aa0ad352 55289-090 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA073449 PD-Rx Pharmaceuticals, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55289-091_575ad8d3-e439-8897-e053-2991aa0a648a 55289-091 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071135 PD-Rx Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-092_5be87bb5-d791-a1c8-e053-2a91aa0a0871 55289-092 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 19850904 ANDA ANDA070325 PD-Rx Pharmaceuticals, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-093_5abf6837-27ef-48dc-e053-2991aa0a884d 55289-093 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 PD-Rx Pharmaceuticals, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55289-094_5aa942d9-6512-3f3b-e053-2991aa0aa484 55289-094 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19710401 ANDA ANDA061454 PD-Rx Pharmaceuticals, Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55289-095_5e85e111-6f75-a32c-e053-2991aa0aed75 55289-095 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 PD-Rx Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 55289-096_5abd2a9a-9eae-3f0c-e053-2a91aa0a9ebe 55289-096 HUMAN PRESCRIPTION DRUG Lotrel amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA NDA020364 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55289-097_5aa50dba-9fd5-3124-e053-2991aa0a03e7 55289-097 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 PD-Rx Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55289-099_5abf9c41-4d7d-39c9-e053-2991aa0a37a8 55289-099 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073554 PD-Rx Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55289-102_5d6a243b-243d-2463-e053-2991aa0a7fb3 55289-102 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 PD-Rx Pharmaceuticals, Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 55289-103_5abd2a9a-9f71-3f0c-e053-2a91aa0a9ebe 55289-103 HUMAN PRESCRIPTION DRUG Norvasc amlodipine besylate TABLET ORAL 19920731 NDA NDA019787 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55289-106_45b03ab4-fb74-19b1-e054-00144ff88e88 55289-106 HUMAN PRESCRIPTION DRUG ZESTRIL Lisinopril TABLET ORAL 20090513 NDA NDA019777 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55289-107_61cfeb06-427b-338e-e053-2a91aa0a9446 55289-107 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20191231 55289-112_5aa99f95-2315-b2cd-e053-2991aa0a5a75 55289-112 HUMAN PRESCRIPTION DRUG Erythrocin Stearate ERYTHROMYCIN STEARATE TABLET, FILM COATED ORAL 20110801 ANDA ANDA060359 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN STEARATE 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55289-117_530cbb6d-5587-0fce-e054-00144ff88e88 55289-117 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 19631115 NDA NDA013263 PD-Rx Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-118_50e8669a-b557-3703-e054-00144ff88e88 55289-118 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 PD-Rx Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55289-119_4572dd6c-3184-285d-e054-00144ff8d46c 55289-119 HUMAN PRESCRIPTION DRUG Compro PROCHLORPERAZINE SUPPOSITORY RECTAL 20000901 ANDA ANDA040246 PD-Rx Pharmaceuticals, Inc. PROCHLORPERAZINE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 55289-124_5aa5b4c8-f939-0df4-e053-2991aa0ada94 55289-124 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 PD-Rx Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55289-125_553976a2-0d7a-5929-e054-00144ff8d46c 55289-125 HUMAN PRESCRIPTION DRUG Glucotrol glipizide TABLET ORAL 19840508 NDA NDA017783 PD-Rx Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55289-132_45722b3e-2b4f-540b-e054-00144ff88e88 55289-132 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20000222 NDA NDA021228 PD-Rx Pharmaceuticals, Inc. TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 55289-136_47e46497-73e8-5cad-e054-00144ff8d46c 55289-136 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20060801 ANDA ANDA084878 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55289-140_5abb584f-9f69-41f0-e053-2991aa0a8c4f 55289-140 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-142_5a942b81-4aa0-6997-e053-2a91aa0afcdc 55289-142 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-144_47a70dc4-ca18-44dc-e054-00144ff88e88 55289-144 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 19760420 ANDA ANDA083745 PD-Rx Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55289-147_56680610-7f45-74a0-e054-00144ff8d46c 55289-147 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 19840420 NDA NDA018858 PD-Rx Pharmaceuticals, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-148_45c3b0e7-5858-5a71-e054-00144ff88e88 55289-148 HUMAN PRESCRIPTION DRUG Diflucan fluconazole TABLET ORAL 19900129 NDA NDA019949 PD-Rx Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 55289-150_61ceb7b5-840f-1166-e053-2a91aa0a3982 55289-150 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 55289-151_45b16d24-dc07-6b10-e054-00144ff8d46c 55289-151 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 19961125 NDA NDA020690 PD-Rx Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 55289-153_47a73774-0e2c-4954-e054-00144ff88e88 55289-153 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20021101 ANDA ANDA076187 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55289-154_45c44b5c-5b38-6c43-e054-00144ff8d46c 55289-154 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55289-158_55f08425-1467-57cc-e054-00144ff88e88 55289-158 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride TABLET ORAL 20100907 ANDA ANDA040747 PD-Rx Pharmaceuticals, Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 55289-160_45c4536a-85ae-749f-e054-00144ff8d46c 55289-160 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 PD-Rx Pharmaceuticals, Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 55289-164_47a7577e-17ba-4bcf-e054-00144ff88e88 55289-164 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 19871101 ANDA ANDA084276 PD-Rx Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55289-166_5e959677-5152-5ae0-e053-2a91aa0ad622 55289-166 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19950928 ANDA ANDA074376 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-168_45c4567d-7879-6459-e054-00144ff88e88 55289-168 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20070905 ANDA ANDA077487 PD-Rx Pharmaceuticals, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55289-171_45c4567d-78a8-6459-e054-00144ff88e88 55289-171 HUMAN PRESCRIPTION DRUG Acarbose Acarbose TABLET ORAL 20080507 ANDA ANDA078470 PD-Rx Pharmaceuticals, Inc. ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 55289-172_567d2a98-4ff7-33c5-e054-00144ff8d46c 55289-172 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 PD-Rx Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 55289-175_29b547bf-c095-14c2-e054-00144ff88e88 55289-175 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 PD-Rx Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 55289-176_5510f584-ce23-411c-e054-00144ff88e88 55289-176 HUMAN PRESCRIPTION DRUG Sulfasalazine sulfasalazine TABLET ORAL 20020111 20190731 ANDA ANDA040349 PD-Rx Pharmaceuticals, Inc. SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 55289-181_5a939402-6e0f-725a-e053-2a91aa0ad3e1 55289-181 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073517 PD-Rx Pharmaceuticals, Inc. KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-182_61ceb7b5-845d-1166-e053-2a91aa0a3982 55289-182 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 20100128 ANDA ANDA064013 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 55289-186_5667105b-bd93-2246-e054-00144ff88e88 55289-186 HUMAN PRESCRIPTION DRUG Nitrofurantoin (macrocrystals) nitrofurantoin (macrocrystals) CAPSULE ORAL 19970909 ANDA ANDA074967 PD-Rx Pharmaceuticals, Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 55289-187_47188e8e-70b3-4c04-e054-00144ff88e88 55289-187 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 PD-Rx Pharmaceuticals, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 55289-193_4665b8b8-6bcd-4f98-e054-00144ff8d46c 55289-193 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20030825 NDA NDA021400 PD-Rx Pharmaceuticals, Inc. VARDENAFIL HYDROCHLORIDE TRIHYDRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 55289-196_5813360c-e03b-934e-e053-2a91aa0a7f12 55289-196 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 PD-Rx Pharmaceuticals, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-201_574ab457-33fb-092a-e053-2a91aa0a96ab 55289-201 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063065 PD-Rx Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 55289-202_574a6bb6-9550-efea-e053-2991aa0a97dd 55289-202 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063181 PD-Rx Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 55289-205_4f4268c2-42ad-49fa-e054-00144ff88e88 55289-205 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20050919 NDA NDA021774 PD-Rx Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 55289-207_47920ef2-1ca2-3e0f-e054-00144ff88e88 55289-207 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 19951130 ANDA ANDA064071 PD-Rx Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55289-211_46529e32-b6fe-04be-e054-00144ff88e88 55289-211 HUMAN PRESCRIPTION DRUG GLUCOPHAGE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20090601 NDA NDA020357 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55289-213_465217ed-e02e-2a1b-e054-00144ff8d46c 55289-213 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 PD-Rx Pharmaceuticals, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 55289-214_5abeea7b-d5ca-cbb3-e053-2991aa0a398a 55289-214 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 PD-Rx Pharmaceuticals, Inc. PREGABALIN 150 mg/1 N 20181231 55289-217_4652324a-9919-637e-e054-00144ff88e88 55289-217 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55289-218_c296d2de-ea1a-4ee4-bdf1-44530b3c91fa 55289-218 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20080825 ANDA ANDA077419 PD-Rx Pharmaceuticals, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55289-221_465217ed-e042-2a1b-e054-00144ff8d46c 55289-221 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528 ANDA ANDA040195 PD-Rx Pharmaceuticals, Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 55289-223_5ace452f-dd5e-c89f-e053-2a91aa0a92d5 55289-223 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 PD-Rx Pharmaceuticals, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 55289-224_429c152e-1cea-5293-e054-00144ff8d46c 55289-224 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20101213 ANDA ANDA040185 PD-Rx Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 55289-226_46643cc7-78ce-044f-e054-00144ff8d46c 55289-226 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 55289-227_5aa608e2-45d1-b95c-e053-2a91aa0a4591 55289-227 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 PD-Rx Pharmaceuticals, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55289-228_56cda4aa-070d-475f-e054-00144ff88e88 55289-228 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 PD-Rx Pharmaceuticals, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55289-233_5acdcc03-8224-22ed-e053-2991aa0a4df3 55289-233 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070176 PD-Rx Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55289-234_50e7cee5-9003-2482-e054-00144ff88e88 55289-234 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 PD-Rx Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55289-236_5510ee23-078d-3beb-e054-00144ff8d46c 55289-236 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20060203 ANDA ANDA073144 PD-Rx Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55289-238_468c01ff-3bea-09dd-e054-00144ff8d46c 55289-238 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55289-241_5b325cde-24cb-c510-e053-2991aa0af411 55289-241 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 PD-Rx Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 55289-248_54d9cc70-3f0a-0fa3-e054-00144ff8d46c 55289-248 HUMAN PRESCRIPTION DRUG Cytotec misoprostol TABLET ORAL 19861227 NDA NDA019268 PD-Rx Pharmaceuticals, Inc. MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 55289-251_468ca758-4c72-5a67-e054-00144ff88e88 55289-251 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 PD-Rx Pharmaceuticals, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 55289-255_55f069ab-3e78-546e-e054-00144ff88e88 55289-255 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 PD-Rx Pharmaceuticals, Inc. PREGABALIN 300 mg/1 N 20181231 55289-257_56f8f856-d4ea-721b-e054-00144ff8d46c 55289-257 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 PD-Rx Pharmaceuticals, Inc. PREGABALIN 100 mg/1 N 20181231 55289-258_54d9eea7-8c57-2acf-e054-00144ff8d46c 55289-258 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 PD-Rx Pharmaceuticals, Inc. DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55289-261_5aa80253-a72d-26fc-e053-2a91aa0adc23 55289-261 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. THYROID, PORCINE 60 mg/1 N 20181231 55289-265_54da1cfc-daaa-6b65-e054-00144ff88e88 55289-265 HUMAN PRESCRIPTION DRUG Tolazamide tolazamide TABLET ORAL 20100105 ANDA ANDA070259 PD-Rx Pharmaceuticals, Inc. TOLAZAMIDE 250 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55289-266_47a6dcd2-4164-217e-e054-00144ff8d46c 55289-266 HUMAN PRESCRIPTION DRUG Evista Raloxifene hydrochloride TABLET ORAL 19980106 NDA NDA020815 PD-Rx Pharmaceuticals, Inc. RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 55289-270_5f9b1ca2-9330-218a-e053-2a91aa0afe1e 55289-270 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100621 ANDA ANDA078477 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55289-272_4790a2d4-962a-6234-e054-00144ff8d46c 55289-272 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 PD-Rx Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-273_575a952a-f907-1b94-e053-2991aa0ae3e5 55289-273 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970423 ANDA ANDA074578 PD-Rx Pharmaceuticals, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55289-275_50fa5067-f7bb-6e60-e054-00144ff88e88 55289-275 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. SALSALATE 500 mg/1 N 20181231 55289-277_46f00426-5425-0819-e054-00144ff88e88 55289-277 HUMAN PRESCRIPTION DRUG Effexor XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 PD-Rx Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-280_4719405d-c0b5-43d7-e054-00144ff8d46c 55289-280 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 PD-Rx Pharmaceuticals, Inc. EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55289-287_54da1cfc-db06-6b65-e054-00144ff88e88 55289-287 HUMAN PRESCRIPTION DRUG Ketoprofen ketoprofen CAPSULE ORAL 19970115 ANDA ANDA074035 PD-Rx Pharmaceuticals, Inc. KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-292_5ace452f-dd48-c89f-e053-2a91aa0a92d5 55289-292 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961101 NDA NDA018333 PD-Rx Pharmaceuticals, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 55289-293_5bc441cc-aeca-29cf-e053-2a91aa0a0d62 55289-293 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55289-297_54da1cfc-db4e-6b65-e054-00144ff88e88 55289-297 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 PD-Rx Pharmaceuticals, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-298_2bd6b511-80f6-0f21-e054-00144ff88e88 55289-298 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 PD-Rx Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-299_50e8b678-a304-3ebd-e054-00144ff8d46c 55289-299 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070323 NDA AUTHORIZED GENERIC NDA019787 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55289-301_46c9fa02-a0a3-72c1-e054-00144ff8d46c 55289-301 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031107 ANDA ANDA076467 PD-Rx Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55289-302_4f961dba-e848-006e-e054-00144ff88e88 55289-302 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 PD-Rx Pharmaceuticals, Inc. PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 55289-306_46c9fa02-a0cd-72c1-e054-00144ff8d46c 55289-306 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 PD-Rx Pharmaceuticals, Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55289-307_5cc72d06-78df-6618-e053-2a91aa0a7bc0 55289-307 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980729 ANDA ANDA075227 PD-Rx Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-310_46c7d50d-8b0a-4983-e054-00144ff88e88 55289-310 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate TABLET, FILM COATED ORAL 19960718 NDA NDA050711 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55289-315_5abd1db3-4f3c-2359-e053-2a91aa0a1a43 55289-315 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 PD-Rx Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 55289-319_5a942b81-4ab7-6997-e053-2a91aa0afcdc 55289-319 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 PD-Rx Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55289-328_5fb43cce-7787-4775-e053-2991aa0a44a1 55289-328 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20130516 ANDA ANDA074761 PD-Rx Pharmaceuticals, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 55289-329_5aaa8b7f-2282-789e-e053-2a91aa0adfdc 55289-329 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19920316 ANDA ANDA072838 PD-Rx Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 55289-330_5f4ae557-bd80-7a97-e053-2a91aa0a1f17 55289-330 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030314 ANDA ANDA084283 PD-Rx Pharmaceuticals, Inc. PREDNISONE 10 mg/1 N 20181231 55289-334_4751327c-3690-10af-e054-00144ff8d46c 55289-334 HUMAN PRESCRIPTION DRUG Fenoprofen Calcium Fenoprofen Calcium TABLET, FILM COATED ORAL 20121114 ANDA ANDA072267 PD-Rx Pharmaceuticals, Inc. FENOPROFEN CALCIUM 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-335_54da1cfc-db73-6b65-e054-00144ff88e88 55289-335 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 19920316 ANDA ANDA072838 PD-Rx Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 55289-337_55f2d95f-b8c8-3765-e054-00144ff88e88 55289-337 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20030201 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. PHENOBARBITAL 32.4 mg/1 CIV N 20181231 55289-338_5758fc0c-686f-9392-e053-2a91aa0a4775 55289-338 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55289-340_4750abaf-8fd0-71ca-e054-00144ff8d46c 55289-340 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 PD-Rx Pharmaceuticals, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 55289-344_477d741c-4f4d-4eb2-e054-00144ff8d46c 55289-344 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 PD-Rx Pharmaceuticals, Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55289-354_5abccb8f-0255-17a8-e053-2a91aa0a9591 55289-354 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 55289-359_5d7d0c0f-40ba-9a58-e053-2991aa0a49db 55289-359 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 PD-Rx Pharmaceuticals, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55289-367_5b5dc2fc-28eb-317e-e053-2991aa0aa20d 55289-367 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 PD-Rx Pharmaceuticals, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-368_5aa942d9-6533-3f3b-e053-2991aa0aa484 55289-368 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride Controlled-Release Diethylpropion Hydrochloride TABLET ORAL 19601117 NDA NDA012546 PD-Rx Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 55289-370_5aa9b22d-7015-8095-e053-2a91aa0afade 55289-370 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 PD-Rx Pharmaceuticals, Inc. DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55289-373_5abdc2bd-ebbf-ae57-e053-2991aa0a5ebc 55289-373 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 PD-Rx Pharmaceuticals, Inc. PREDNISONE 5 mg/1 N 20181231 55289-376_4751480b-7f82-13b1-e054-00144ff8d46c 55289-376 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077923 PD-Rx Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-379_56cc21fd-f599-1b52-e054-00144ff88e88 55289-379 HUMAN PRESCRIPTION DRUG Adipex-P Phentermine Hydrochloride TABLET ORAL 19900930 ANDA ANDA085128 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 55289-381_5abd475c-5783-749a-e053-2991aa0aaeea 55289-381 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-382_4f54610b-caa7-61bd-e054-00144ff8d46c 55289-382 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20120502 ANDA ANDA076704 PD-Rx Pharmaceuticals, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55289-384_480c192e-7374-1ce2-e054-00144ff88e88 55289-384 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55289-385_47526445-a060-4948-e054-00144ff8d46c 55289-385 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 PD-Rx Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55289-393_4752d88f-2bf9-609d-e054-00144ff8d46c 55289-393 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 PD-Rx Pharmaceuticals, Inc. CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55289-394_4e2be9f9-18fb-0fb1-e054-00144ff8d46c 55289-394 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 55289-395_f3e03879-bdec-4cfa-9146-c1d586f84b2b 55289-395 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20110613 ANDA ANDA076052 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55289-402_61cedbd3-55d8-393a-e053-2a91aa0a11fe 55289-402 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072926 PD-Rx Pharmaceuticals, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55289-403_94326c04-9c9c-41c4-a593-d6fa85898d8f 55289-403 HUMAN PRESCRIPTION DRUG Comfort Pac With Cyclobenzaprine Cyclobenzaprine Hydrochloride KIT 20130715 ANDA ANDA078218 PD-Rx Pharmaceuticals, Inc. N 20181231 55289-406_483298ff-b8c1-1fea-e054-00144ff8d46c 55289-406 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 19971224 NDA NDA020607 PD-Rx Pharmaceuticals, Inc. DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 55289-409_4832b2be-39ec-2bce-e054-00144ff88e88 55289-409 HUMAN PRESCRIPTION DRUG Zoloft sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 PD-Rx Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-410_4921b160-1d75-1696-e054-00144ff88e88 55289-410 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 19950117 NDA NDA020241 PD-Rx Pharmaceuticals, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55289-411_566ce6f5-5791-6593-e054-00144ff88e88 55289-411 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19930927 20180331 ANDA ANDA074270 PD-Rx Pharmaceuticals, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 55289-413_49887b46-fd8c-4f5c-e054-00144ff8d46c 55289-413 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 PD-Rx Pharmaceuticals, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55289-419_4f434cbc-30c9-6554-e054-00144ff88e88 55289-419 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076578 PD-Rx Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 55289-433_4832b2be-3a65-2bce-e054-00144ff88e88 55289-433 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 PD-Rx Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55289-436_4921a888-da99-1489-e054-00144ff88e88 55289-436 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 PD-Rx Pharmaceuticals, Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55289-441_4988672c-5021-39fd-e054-00144ff8d46c 55289-441 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19910731 ANDA ANDA063083 PD-Rx Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 55289-443_4921a888-da68-1489-e054-00144ff88e88 55289-443 HUMAN PRESCRIPTION DRUG Benicar HCT olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 PD-Rx Pharmaceuticals, Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55289-444_4a53607d-9daf-478a-e054-00144ff8d46c 55289-444 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 PD-Rx Pharmaceuticals, Inc. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55289-445_48bcfd05-5b37-5c0b-e054-00144ff8d46c 55289-445 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040114 ANDA ANDA076494 PD-Rx Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-447_492037eb-71b5-41cd-e054-00144ff8d46c 55289-447 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 PD-Rx Pharmaceuticals, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 55289-448_56cc21fd-f62a-1b52-e054-00144ff88e88 55289-448 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070323 NDA AUTHORIZED GENERIC NDA019787 PD-Rx Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55289-449_578522b4-c267-19fd-e053-2991aa0a377d 55289-449 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089990 PD-Rx Pharmaceuticals, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 15; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 55289-451_48bd97f5-61eb-03be-e054-00144ff8d46c 55289-451 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 PD-Rx Pharmaceuticals, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-453_48faef92-3bb9-3dd1-e054-00144ff88e88 55289-453 HUMAN PRESCRIPTION DRUG Daypro oxaprozin TABLET, FILM COATED ORAL 19921029 NDA NDA018841 PD-Rx Pharmaceuticals, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-457_4c5e6f09-5bf7-6b0a-e054-00144ff8d46c 55289-457 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100225 ANDA ANDA076899 PD-Rx Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 55289-460_566b106f-f495-2604-e054-00144ff88e88 55289-460 HUMAN PRESCRIPTION DRUG Diflunisal Diflunisal TABLET, FILM COATED ORAL 19921101 ANDA ANDA073673 PD-Rx Pharmaceuticals, Inc. DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-462_5aa50dba-a057-3124-e053-2991aa0a03e7 55289-462 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 PD-Rx Pharmaceuticals, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55289-463_48fbed7d-a953-066b-e054-00144ff8d46c 55289-463 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 PD-Rx Pharmaceuticals, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 55289-464_48bf6884-2e8a-615e-e054-00144ff8d46c 55289-464 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20080212 ANDA ANDA040724 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 55289-465_490da075-2ced-5006-e054-00144ff88e88 55289-465 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 PD-Rx Pharmaceuticals, Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 55289-466_5c73ed98-3c47-b4bc-e053-2991aa0a239a 55289-466 HUMAN PRESCRIPTION DRUG Comfort Pac with Naproxen Naproxen KIT 20100218 ANDA ANDA075927 PD-Rx Pharmaceuticals, Inc. N 20181231 55289-467_48bf6d8b-8c5f-61a0-e054-00144ff8d46c 55289-467 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070801 ANDA ANDA078314 PD-Rx Pharmaceuticals, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-469_5786a19c-dcd1-d109-e053-2991aa0ab028 55289-469 HUMAN PRESCRIPTION DRUG INDOMETHACIN Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20090306 ANDA ANDA079175 PD-Rx Pharmaceuticals, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-470_490f544d-7884-0b6e-e054-00144ff88e88 55289-470 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971001 NDA NDA020658 PD-Rx Pharmaceuticals, Inc. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55289-475_48c0cf87-4636-4132-e054-00144ff88e88 55289-475 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 PD-Rx Pharmaceuticals, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-477_4a5388f1-5d84-63cb-e054-00144ff88e88 55289-477 HUMAN PRESCRIPTION DRUG VIRACEPT nelfinavir mesylate TABLET, FILM COATED ORAL 19970314 NDA NDA020779 PD-Rx Pharmaceuticals, Inc. NELFINAVIR MESYLATE 250 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] N 20181231 55289-481_493a8fbf-9b66-5650-e054-00144ff8d46c 55289-481 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED ORAL 19890215 ANDA ANDA071483 PD-Rx Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55289-487_5a94257d-9183-ec3d-e053-2991aa0ad703 55289-487 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 PD-Rx Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-488_5a94b43f-e01b-27c5-e053-2991aa0a8484 55289-488 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA071851 PD-Rx Pharmaceuticals, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55289-491_49120bc1-f4e7-0313-e054-00144ff8d46c 55289-491 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 PD-Rx Pharmaceuticals, Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 55289-492_5fc47422-8dbc-735a-e053-2991aa0a7553 55289-492 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 PD-Rx Pharmaceuticals, Inc. FOLIC ACID 1 mg/1 N 20181231 55289-493_5e98cfdf-3333-2025-e053-2991aa0a036d 55289-493 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20171122 20271130 OTC MONOGRAPH NOT FINAL part334 PD-Rx Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 55289-501_48faba58-e4a1-43d4-e054-00144ff8d46c 55289-501 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980430 ANDA ANDA075078 PD-Rx Pharmaceuticals, Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-502_5a96f12e-84f5-fad6-e053-2a91aa0a879f 55289-502 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19841107 ANDA ANDA062396 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 55289-505_4a5388f1-5dd4-63cb-e054-00144ff88e88 55289-505 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 19980401 ANDA ANDA075165 PD-Rx Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55289-511_55f294f4-2596-2ec0-e054-00144ff88e88 55289-511 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20070131 ANDA ANDA077712 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55289-519_4911f343-6839-71b0-e054-00144ff8d46c 55289-519 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 19931229 NDA NDA020272 PD-Rx Pharmaceuticals, Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 55289-520_4a53964f-f8c3-505f-e054-00144ff8d46c 55289-520 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 PD-Rx Pharmaceuticals, Inc. EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55289-521_574a6bb6-951b-efea-e053-2991aa0a97dd 55289-521 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 PD-Rx Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 55289-522_4939a547-c8e4-3350-e054-00144ff88e88 55289-522 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 PD-Rx Pharmaceuticals, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55289-523_5aa4f1c7-3c43-0f62-e053-2991aa0a094e 55289-523 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19980325 ANDA ANDA074909 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-524_4939ff45-7b12-3805-e054-00144ff8d46c 55289-524 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 PD-Rx Pharmaceuticals, Inc. SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 55289-525_61d0830f-05b1-542b-e053-2991aa0a0aff 55289-525 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 PD-Rx Pharmaceuticals, Inc. ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 55289-535_56e61bac-49d6-418e-e054-00144ff8d46c 55289-535 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20030201 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. PHENOBARBITAL 32.4 mg/1 CIV N 20181231 55289-559_4db33844-f5f2-69fb-e054-00144ff8d46c 55289-559 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 PD-Rx Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55289-561_5aaac81d-989d-e7a9-e053-2991aa0a3540 55289-561 HUMAN PRESCRIPTION DRUG Flurbiprofen flurbiprofen TABLET, FILM COATED ORAL 19940620 ANDA ANDA074358 PD-Rx Pharmaceuticals, Inc. FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-563_60411971-b3a4-7d65-e053-2a91aa0a5537 55289-563 HUMAN OTC DRUG Acetaminophen Regular strength Acetaminophen TABLET ORAL 20070109 OTC MONOGRAPH NOT FINAL part343 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN 325 mg/1 N 20181231 55289-565_5beaad65-4e9f-3052-e053-2a91aa0a6407 55289-565 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55289-567_3e08af89-92f3-4b9e-807d-77cd2b00bd38 55289-567 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 PD-Rx Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55289-568_5fc3abdd-d3f5-c060-e053-2991aa0a0e8f 55289-568 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 19961118 ANDA ANDA040185 PD-Rx Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 55289-569_6364c769-6e0c-51e9-e053-2a91aa0a78f9 55289-569 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 PD-Rx Pharmaceuticals, Inc. PREGABALIN 75 mg/1 N 20191231 55289-577_5ace2473-4d12-979c-e053-2a91aa0af7db 55289-577 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 PD-Rx Pharmaceuticals, Inc. SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 55289-581_5aa6c8c1-0f5c-ade7-e053-2991aa0aac64 55289-581 HUMAN PRESCRIPTION DRUG Cimetidine cimetidine TABLET, FILM COATED ORAL 20110504 ANDA ANDA074246 PD-Rx Pharmaceuticals, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55289-582_476ba02f-f485-378e-e054-00144ff88e88 55289-582 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 PD-Rx Pharmaceuticals, Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55289-586_4a2b5f25-a2fa-15f3-e054-00144ff8d46c 55289-586 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073553 PD-Rx Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55289-589_4c6c1a2a-cebd-280e-e054-00144ff8d46c 55289-589 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070131 ANDA ANDA065282 PD-Rx Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55289-590_5a9444a0-4652-20fa-e053-2991aa0abe4d 55289-590 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 PD-Rx Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-591_588c414f-8efe-28f8-e053-2a91aa0aa30e 55289-591 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 PD-Rx Pharmaceuticals, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55289-592_61cef09a-e71e-31e5-e053-2a91aa0ad77f 55289-592 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 PD-Rx Pharmaceuticals, Inc. DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 55289-593_4939f9e7-d263-3566-e054-00144ff8d46c 55289-593 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 PD-Rx Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55289-594_5ab92993-5bea-20f6-e053-2991aa0aa877 55289-594 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072928 PD-Rx Pharmaceuticals, Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-599_531ab28d-5141-729b-e054-00144ff88e88 55289-599 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 20190930 ANDA ANDA077856 PD-Rx Pharmaceuticals, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-600_49399340-115a-3497-e054-00144ff88e88 55289-600 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 PD-Rx Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55289-601_567fc4b2-1579-429e-e054-00144ff88e88 55289-601 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20030512 ANDA ANDA075849 PD-Rx Pharmaceuticals, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-603_5aa99f95-234f-b2cd-e053-2991aa0a5a75 55289-603 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 20091217 ANDA ANDA040326 PD-Rx Pharmaceuticals, Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 55289-606_5aa4f1c7-3bb1-0f62-e053-2991aa0a094e 55289-606 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 PD-Rx Pharmaceuticals, Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55289-607_493a348f-4f22-4272-e054-00144ff8d46c 55289-607 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 PD-Rx Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55289-609_5a971937-e84e-a0ea-e053-2991aa0a5730 55289-609 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20020225 ANDA ANDA075280 PD-Rx Pharmaceuticals, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-610_5f49f091-2dff-44af-e053-2991aa0a6864 55289-610 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20020129 ANDA ANDA075049 PD-Rx Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-611_4bd1ac39-cebb-1646-e054-00144ff8d46c 55289-611 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20020225 ANDA ANDA075280 PD-Rx Pharmaceuticals, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-612_4a2b2e55-3f9f-1b90-e054-00144ff8d46c 55289-612 HUMAN PRESCRIPTION DRUG Zanaflex tizanidine hydrochloride TABLET ORAL 19970101 NDA NDA020397 PD-Rx Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55289-613_4a2b2e55-3f44-1b90-e054-00144ff8d46c 55289-613 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20021015 ANDA ANDA075465 PD-Rx Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-615_4a5483c2-1073-0f08-e054-00144ff8d46c 55289-615 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020128 ANDA ANDA075978 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55289-617_4f446206-6757-1bbe-e054-00144ff88e88 55289-617 HUMAN PRESCRIPTION DRUG ULTRACET tramadol hydrochloride and acetaminophen TABLET, COATED ORAL 20010815 NDA NDA021123 PD-Rx Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 55289-618_4e29d4ed-de12-2529-e054-00144ff8d46c 55289-618 HUMAN PRESCRIPTION DRUG Mobic meloxicam TABLET ORAL 20000601 NDA NDA020938 PD-Rx Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-624_5b4b84b4-54d8-d564-e053-2a91aa0a3fe5 55289-624 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 55289-626_4a675f27-1dfe-4ee8-e054-00144ff8d46c 55289-626 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 PD-Rx Pharmaceuticals, Inc. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 55289-629_56cb51dd-c7f8-4e5e-e054-00144ff8d46c 55289-629 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970430 ANDA ANDA074556 PD-Rx Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55289-633_56d0eed7-25f3-0f35-e054-00144ff8d46c 55289-633 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 PD-Rx Pharmaceuticals, Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55289-638_4db2857b-8e3c-564f-e054-00144ff88e88 55289-638 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20051117 ANDA ANDA077321 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55289-640_65daea3d-0608-4d18-8066-b813d325f474 55289-640 HUMAN PRESCRIPTION DRUG misoprostol misoprostol TABLET ORAL 20091227 NDA NDA019268 PD-Rx Pharmaceuticals, Inc. MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 55289-649_5abd2a9a-9f5a-3f0c-e053-2a91aa0a9ebe 55289-649 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 19981222 ANDA ANDA040183 PD-Rx Pharmaceuticals, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55289-650_4f44d015-397a-2c4e-e054-00144ff88e88 55289-650 HUMAN PRESCRIPTION DRUG ULTRAM tramadol hydrochloride TABLET, COATED ORAL 19950303 NDA NDA020281 PD-Rx Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 55289-653_4a676320-9501-545e-e054-00144ff8d46c 55289-653 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 PD-Rx Pharmaceuticals, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55289-660_5e1f9210-945a-52e6-e053-2a91aa0a5a46 55289-660 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 PD-Rx Pharmaceuticals, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-663_5ab9407f-96fc-b5a7-e053-2a91aa0a919c 55289-663 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 19840420 NDA NDA018858 PD-Rx Pharmaceuticals, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-692_56f8e191-ee0f-70f9-e054-00144ff8d46c 55289-692 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 PD-Rx Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55289-694_5827a9e7-5b3d-3f90-e053-2a91aa0a2369 55289-694 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 PD-Rx Pharmaceuticals, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55289-696_50233be9-2647-2936-e054-00144ff88e88 55289-696 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55289-697_4c72dfaf-c08f-2380-e054-00144ff88e88 55289-697 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 PD-Rx Pharmaceuticals, Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55289-701_5b4b3da2-a144-ee72-e053-2991aa0a51ce 55289-701 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040876 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 55289-704_50fa2757-235d-1782-e054-00144ff8d46c 55289-704 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 19950510 NDA NDA020406 PD-Rx Pharmaceuticals, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 55289-707_635f3672-dea9-cf18-e053-2a91aa0a1061 55289-707 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 55289-711_5e816bf1-0ec3-1e17-e053-2991aa0abc99 55289-711 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 55289-711_880f99c9-11d6-41dd-a33a-de90a45cb707 55289-711 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 PD-Rx Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 55289-719_5a943e77-c663-1a6c-e053-2991aa0afdd6 55289-719 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 PD-Rx Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 55289-720_60f16569-f5ad-8f80-e053-2a91aa0a39de 55289-720 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 19970528 ANDA ANDA040195 PD-Rx Pharmaceuticals, Inc. ACETAZOLAMIDE 125 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 55289-723_5ace7fce-8de3-3e0c-e053-2991aa0aad45 55289-723 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090917 ANDA ANDA078906 PD-Rx Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55289-725_4a67adea-1539-633c-e054-00144ff8d46c 55289-725 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19910731 ANDA ANDA073191 PD-Rx Pharmaceuticals, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55289-730_566a9461-6287-18db-e054-00144ff88e88 55289-730 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 PD-Rx Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55289-733_4b42dbb6-f76a-6276-e054-00144ff8d46c 55289-733 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000511 ANDA ANDA075491 PD-Rx Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 55289-736_56bb6643-dfb8-67ff-e054-00144ff88e88 55289-736 HUMAN PRESCRIPTION DRUG SKELAXIN metaxalone TABLET ORAL 20020830 NDA NDA013217 PD-Rx Pharmaceuticals, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 55289-737_576ca7c0-cb55-2911-e053-2a91aa0af95e 55289-737 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040746 PD-Rx Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 55289-738_5e979013-188c-4cfd-e053-2991aa0ae484 55289-738 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 PD-Rx Pharmaceuticals, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55289-747_5746522f-a4e5-d78c-e053-2a91aa0a49c8 55289-747 HUMAN PRESCRIPTION DRUG MALARONE atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20000726 NDA NDA021078 PD-Rx Pharmaceuticals, Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 55289-757_5aa618f1-af33-df55-e053-2a91aa0ad53e 55289-757 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072234 PD-Rx Pharmaceuticals, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 55289-761_4c725fd5-3bcc-6db5-e054-00144ff8d46c 55289-761 HUMAN PRESCRIPTION DRUG Estradiol estradiol TABLET ORAL 20091217 ANDA ANDA040326 PD-Rx Pharmaceuticals, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 55289-765_5aaaf6d7-87bc-4a01-e053-2991aa0a90cf 55289-765 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20110211 ANDA ANDA075511 PD-Rx Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55289-767_5c4bad7e-f3b4-4a35-e053-2991aa0a839c 55289-767 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 55289-768_4b43f5a8-0bb7-2153-e054-00144ff8d46c 55289-768 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-779_56300dd0-1a53-1c7b-e054-00144ff8d46c 55289-779 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031101 ANDA ANDA076467 PD-Rx Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55289-781_5ae5a856-e5f5-480e-e053-2a91aa0a6454 55289-781 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19981120 ANDA ANDA075229 PD-Rx Pharmaceuticals, Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-784_5b35e153-5a1a-4e7b-e053-2991aa0a456d 55289-784 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20020627 ANDA ANDA076280 PD-Rx Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55289-787_5c658e49-0885-3777-e053-2a91aa0ae5cd 55289-787 HUMAN PRESCRIPTION DRUG Triazolam triazolam TABLET ORAL 19821115 NDA AUTHORIZED GENERIC NDA017892 PD-Rx Pharmaceuticals, Inc. TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-791_5b4b60a5-cd77-c92d-e053-2a91aa0a2b3c 55289-791 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 PD-Rx Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 55289-794_4f450c60-fadf-4b9a-e054-00144ff8d46c 55289-794 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 19590806 NDA NDA011722 PD-Rx Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 55289-798_5a9444a0-4660-20fa-e053-2991aa0abe4d 55289-798 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 PD-Rx Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55289-800_56561c5d-7989-1fd1-e054-00144ff8d46c 55289-800 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium trihydrate TABLET, FILM COATED ORAL 19961217 NDA NDA020702 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55289-806_5fc4b67b-8e41-42db-e053-2a91aa0a7a4e 55289-806 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 PD-Rx Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55289-809_4c5d582b-d852-305c-e054-00144ff88e88 55289-809 HUMAN PRESCRIPTION DRUG tizanidine tizanidine hydrochloride TABLET ORAL 20021126 ANDA ANDA076280 PD-Rx Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55289-814_55f21788-aa44-1510-e054-00144ff88e88 55289-814 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 PD-Rx Pharmaceuticals, Inc. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55289-816_4cd3ed41-ecd0-53a4-e054-00144ff88e88 55289-816 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate TABLET ORAL 19590603 NDA AUTHORIZED GENERIC NDA011839 PD-Rx Pharmaceuticals, Inc. MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 55289-817_4a67ff5a-2cf1-72dc-e054-00144ff8d46c 55289-817 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 PD-Rx Pharmaceuticals, Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55289-820_4a67f0d0-785b-433b-e054-00144ff88e88 55289-820 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 PD-Rx Pharmaceuticals, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55289-821_4ce932f7-46b2-2caf-e054-00144ff88e88 55289-821 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55289-822_4f32ccab-c8bb-3e02-e054-00144ff88e88 55289-822 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 PD-Rx Pharmaceuticals, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 55289-823_4ce963f1-6f8a-1842-e054-00144ff8d46c 55289-823 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55289-824_4ce98aba-d108-6ae3-e054-00144ff8d46c 55289-824 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 PD-Rx Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 55289-825_4a68456e-4185-5371-e054-00144ff88e88 55289-825 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 PD-Rx Pharmaceuticals, Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55289-826_4d771c80-73b6-34b1-e054-00144ff8d46c 55289-826 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 PD-Rx Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55289-828_4ceabf46-0b39-5bd2-e054-00144ff88e88 55289-828 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 PD-Rx Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-838_4a68456e-41be-5371-e054-00144ff88e88 55289-838 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 PD-Rx Pharmaceuticals, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55289-844_4b565c73-a57b-44eb-e054-00144ff8d46c 55289-844 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. SALSALATE 750 mg/1 N 20181231 55289-845_5c4b8bfc-06d5-1eb2-e053-2a91aa0a4d0b 55289-845 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 PD-Rx Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 55289-853_4a6853d4-5688-0fdc-e054-00144ff8d46c 55289-853 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110908 ANDA ANDA075124 PD-Rx Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 55289-856_4ce9ab72-1d37-38ad-e054-00144ff88e88 55289-856 HUMAN PRESCRIPTION DRUG Chloroquine Chloroquine Phosphate TABLET, COATED ORAL 19990917 ANDA ANDA083082 PD-Rx Pharmaceuticals, Inc. CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] N 20181231 55289-858_5ab92993-5bc6-20f6-e053-2991aa0aa877 55289-858 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 PD-Rx Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55289-861_4e2b9b66-400a-6db8-e054-00144ff88e88 55289-861 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55289-866_5a9485fe-1d25-680f-e053-2a91aa0ad830 55289-866 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 PD-Rx Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 55289-870_4e2be9f9-199a-0fb1-e054-00144ff8d46c 55289-870 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 PD-Rx Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55289-872_4b56f58f-4534-0236-e054-00144ff88e88 55289-872 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 PD-Rx Pharmaceuticals, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 55289-876_4aa335d1-1ea2-72c8-e054-00144ff8d46c 55289-876 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 PD-Rx Pharmaceuticals, Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55289-877_4cea8df3-9792-5527-e054-00144ff88e88 55289-877 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 PD-Rx Pharmaceuticals, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55289-878_4aa335d1-1e74-72c8-e054-00144ff8d46c 55289-878 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 PD-Rx Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55289-879_56cf6875-88f8-2bbf-e054-00144ff8d46c 55289-879 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 PD-Rx Pharmaceuticals, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 55289-880_6297c6d6-a0fe-e6f3-e053-2991aa0a2c6e 55289-880 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20180112 OTC MONOGRAPH NOT FINAL part343 PD-Rx Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 N 20191231 55289-881_5aa4e817-10d5-9e58-e053-2991aa0a9cb2 55289-881 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20071101 ANDA ANDA078296 PD-Rx Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55289-883_4b564a4c-4f00-2f36-e054-00144ff8d46c 55289-883 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20150529 ANDA ANDA077032 PD-Rx Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-884_4db2c9c5-1cc1-49ab-e054-00144ff8d46c 55289-884 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20051117 ANDA ANDA077321 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55289-890_5fc4d8fb-b085-74a6-e053-2a91aa0ac8af 55289-890 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140909 ANDA ANDA063083 PD-Rx Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 55289-891_55f26e31-f67a-04dd-e054-00144ff8d46c 55289-891 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55289-895_55f2a398-c14e-679a-e054-00144ff8d46c 55289-895 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 PD-Rx Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 55289-898_4e184b68-3220-57d3-e054-00144ff88e88 55289-898 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55289-903_478fbbfc-efab-32ae-e054-00144ff8d46c 55289-903 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603 ANDA ANDA084613 PD-Rx Pharmaceuticals, Inc. DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55289-906_4e8cdf3f-af9d-31c3-e054-00144ff88e88 55289-906 HUMAN PRESCRIPTION DRUG EXTENDED PHENYTOIN SODIUM EXTENDED PHENYTOIN SODIUM CAPSULE ORAL 20080130 ANDA ANDA040732 PD-Rx Pharmaceuticals, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 55289-907_5abf9c41-4d65-39c9-e053-2991aa0a37a8 55289-907 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20090811 ANDA ANDA072781 PD-Rx Pharmaceuticals, Inc. NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55289-908_5aa52c22-f624-421c-e053-2991aa0aaf46 55289-908 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE TABLET ORAL 19590603 NDA AUTHORIZED GENERIC NDA011839 PD-Rx Pharmaceuticals, Inc. MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 55289-909_52a38315-1c59-1a0c-e054-00144ff88e88 55289-909 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 PD-Rx Pharmaceuticals, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55289-911_4e7dbe0f-4ad6-17ac-e054-00144ff88e88 55289-911 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 19971117 NDA NDA020839 PD-Rx Pharmaceuticals, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 55289-912_5abaeca7-754f-3a26-e053-2a91aa0a05d3 55289-912 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 PD-Rx Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 55289-916_55f1bfc4-33e1-0d5d-e054-00144ff88e88 55289-916 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089828 PD-Rx Pharmaceuticals, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 60; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 55289-917_5c4be78f-ce7f-78f1-e053-2a91aa0a6425 55289-917 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 PD-Rx Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55289-919_4e7dbe0f-4b1a-17ac-e054-00144ff88e88 55289-919 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20030417 ANDA ANDA075978 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55289-920_4f457a86-b8c6-5b53-e054-00144ff8d46c 55289-920 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19940128 ANDA ANDA074215 PD-Rx Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-923_5c8c3bee-cdec-a776-e053-2a91aa0a2d40 55289-923 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 PD-Rx Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 55289-924_4e28dd2a-45b7-6899-e054-00144ff8d46c 55289-924 HUMAN PRESCRIPTION DRUG METHOTREXATE METHOTREXATE TABLET ORAL 19531207 NDA NDA008085 PD-Rx Pharmaceuticals, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 55289-926_4e8fb6a5-349e-0f93-e054-00144ff88e88 55289-926 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 19950801 NDA NDA020487 PD-Rx Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55289-928_5b5dc2fc-28cf-317e-e053-2991aa0aa20d 55289-928 HUMAN PRESCRIPTION DRUG PROMETHEGAN Promethazine Hydrochloride SUPPOSITORY RECTAL 20020228 ANDA ANDA040428 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 55289-930_4e183e42-5781-562e-e054-00144ff88e88 55289-930 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071795 PD-Rx Pharmaceuticals, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55289-932_4ea4f843-14a6-10d9-e054-00144ff8d46c 55289-932 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 PD-Rx Pharmaceuticals, Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55289-934_4e7d702d-bd71-10b2-e054-00144ff88e88 55289-934 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20020129 ANDA ANDA075967 PD-Rx Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55289-935_4ea517e7-1578-1749-e054-00144ff8d46c 55289-935 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 PD-Rx Pharmaceuticals, Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55289-937_5abf589b-0b1c-8253-e053-2991aa0a1028 55289-937 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20031016 NDA NDA021487 PD-Rx Pharmaceuticals, Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 55289-939_54b105b7-7d11-5b84-e054-00144ff88e88 55289-939 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 20181031 ANDA ANDA075350 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55289-940_5e6c9460-1332-0d34-e053-2a91aa0adcd4 55289-940 HUMAN PRESCRIPTION DRUG PHENADOZ Promethazine Hydrochloride SUPPOSITORY RECTAL 20030624 ANDA ANDA040479 PD-Rx Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 55289-944_57711166-1eba-3c0e-e053-2a91aa0a65e0 55289-944 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 PD-Rx Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 55289-947_5aa4f1c7-3c0a-0f62-e053-2991aa0a094e 55289-947 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 PD-Rx Pharmaceuticals, Inc. LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 55289-951_5c73dea6-4097-481e-e053-2a91aa0a0746 55289-951 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 PD-Rx Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55289-954_4e8f7ede-528d-097b-e054-00144ff88e88 55289-954 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET ORAL 20080401 ANDA ANDA065130 PD-Rx Pharmaceuticals, Inc. CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55289-959_5aa4b664-42ba-ee87-e053-2a91aa0ad0c5 55289-959 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 PD-Rx Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55289-963_4ea50299-3a21-6100-e054-00144ff88e88 55289-963 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 PD-Rx Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55289-964_54c41112-818a-1475-e054-00144ff8d46c 55289-964 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 PD-Rx Pharmaceuticals, Inc. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55289-969_6364e152-bdfc-526b-e053-2a91aa0a7a01 55289-969 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 PD-Rx Pharmaceuticals, Inc. PREGABALIN 50 mg/1 N 20191231 55289-970_4ea50299-3a02-6100-e054-00144ff88e88 55289-970 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 19870609 ANDA ANDA070317 PD-Rx Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55289-971_50ff3ed1-9a63-2b86-e054-00144ff88e88 55289-971 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 PD-Rx Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55289-972_5abd1c11-094f-1819-e053-2a91aa0a295b 55289-972 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 PD-Rx Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55289-976_5d7d4beb-faa5-de62-e053-2a91aa0a8511 55289-976 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 PD-Rx Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55289-979_5aa91280-cda8-7152-e053-2991aa0a7aa2 55289-979 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071134 PD-Rx Pharmaceuticals, Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55289-984_5aa9b4eb-ccb7-e5d5-e053-2991aa0a00a5 55289-984 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 PD-Rx Pharmaceuticals, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55289-993_5aa618f1-aee6-df55-e053-2a91aa0ad53e 55289-993 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 PD-Rx Pharmaceuticals, Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 55289-996_5bd7b1ba-77ab-5edd-e053-2a91aa0a0857 55289-996 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040749 PD-Rx Pharmaceuticals, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 55289-997_575ceddb-793a-8190-e053-2a91aa0afcf0 55289-997 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 PD-Rx Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 55292-104_50d1a9af-1983-466f-e054-00144ff8d46c 55292-104 HUMAN PRESCRIPTION DRUG Desoxyn methamphetamine hydrochloride TABLET ORAL 19431231 NDA NDA005378 RECORDATI RARE DISEASES, INC. METHAMPHETAMINE HYDROCHLORIDE 5 mg/1 Amphetamine Anorectic [EPC],Amphetamines [Chemical/Ingredient],Appetite Suppression [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE] CII N 20181231 55292-122_4e172a95-c15b-26bf-e054-00144ff88e88 55292-122 HUMAN PRESCRIPTION DRUG NeoProfen ibuprofen lysine SOLUTION INTRAVENOUS 20060413 NDA NDA021903 RECORDATI RARE DISEASES, INC. IBUPROFEN LYSINE 10 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55292-201_32fdbfad-911d-55f6-e054-00144ff88e88 55292-201 HUMAN PRESCRIPTION DRUG Chemet succimer CAPSULE ORAL 20130821 NDA NDA019998 RECORDATI RARE DISEASES, INC. SUCCIMER 100 mg/1 Lead Chelating Activity [MoA],Lead Chelator [EPC] N 20181231 55292-302_ba932685-2ac6-4bbd-af52-e1aedd03e328 55292-302 HUMAN PRESCRIPTION DRUG Tranxene T-Tab clorazepate dipotassium TABLET ORAL 19720623 20180419 NDA NDA017105 RECORDATI RARE DISEASES, INC. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55292-304_ba932685-2ac6-4bbd-af52-e1aedd03e328 55292-304 HUMAN PRESCRIPTION DRUG Tranxene T-Tab clorazepate dipotassium TABLET ORAL 19720623 NDA NDA017105 RECORDATI RARE DISEASES, INC. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55292-601_5047477f-e443-4681-8716-e0d0b9a61cbc 55292-601 HUMAN PRESCRIPTION DRUG Peganone ethotoin TABLET ORAL 19570422 20180831 NDA NDA010841 RECORDATI RARE DISEASES, INC. ETHOTOIN 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55292-602_5047477f-e443-4681-8716-e0d0b9a61cbc 55292-602 HUMAN PRESCRIPTION DRUG Peganone ethotoin TABLET ORAL 19570422 NDA NDA010841 RECORDATI RARE DISEASES, INC. ETHOTOIN 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55292-701_cdfd9947-bc51-43c9-9bd0-130c214bb68a 55292-701 HUMAN PRESCRIPTION DRUG Panhematin hemin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19830720 20200124 BLA BLA101246 RECORDATI RARE DISEASES, INC. HEMIN 7 mg/mL N 20181231 55292-702_ba89eb18-9ccb-42b3-95cf-7493def009a3 55292-702 HUMAN PRESCRIPTION DRUG Panhematin hemin POWDER, FOR SOLUTION INTRAVENOUS 19830720 BLA BLA101246 RECORDATI RARE DISEASES, INC. HEMIN 7 mg/mL N 20181231 55292-811_dcbf4425-ab68-edcf-9b16-3ac62668150d 55292-811 HUMAN PRESCRIPTION DRUG Cosmegen dactinomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19641210 NDA NDA050682 RECORDATI RARE DISEASES, INC. DACTINOMYCIN .5 mg/mL Actinomycin [EPC],Nucleic Acid Synthesis Inhibitors [MoA],Protein Synthesis Inhibitors [MoA] N 20181231 55292-911_f403750e-2b49-9dc7-8139-7563864ac611 55292-911 HUMAN PRESCRIPTION DRUG Mustargen mechlorethamine hydrochloride POWDER, FOR SOLUTION INTRACAVITARY; INTRAVENOUS 19490315 NDA NDA006695 RECORDATI RARE DISEASES, INC. MECHLORETHAMINE HYDROCHLORIDE 10 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 55298-013_8e9a93d6-f0ff-4ea5-bed9-688ab924aa85 55298-013 HUMAN OTC DRUG Titralac Plus Calcium Carbonate, Dimethicone TABLET ORAL 20040101 OTC MONOGRAPH FINAL part331 iNova Pharmaceuticals Pty, Ltd CALCIUM CARBONATE; DIMETHICONE 420; 21 mg/1; mg/1 E 20171231 55298-038_dfb735c1-d80e-4fed-b1f7-dce766aa3848 55298-038 HUMAN OTC DRUG Titralac Calcium Carbonate TABLET ORAL 20040101 OTC MONOGRAPH FINAL part331 iNova Pharmaceuticals Pty, Ltd CALCIUM CARBONATE 420 mg/1 E 20171231 55301-000_9a44a271-73ba-497e-bbea-f7c57e84de6b 55301-000 HUMAN OTC DRUG Exchange Select Sunscreen SPF 15 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g N 20181231 55301-001_297e84d7-c76d-485d-9d34-99d2eff5be6a 55301-001 HUMAN OTC DRUG Exchange Select Sunscreen SPF 45 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 12; 5; 1.6; 3.5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-002_607e1534-a267-4be3-bad7-3edcf4bd31af 55301-002 HUMAN OTC DRUG Exchange Select Sport Sunscreen SPF 15 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE OCTINOXATE; OCTISALATE; OXYBENZONE 6; 5; 2 g/100g; g/100g; g/100g N 20181231 55301-003_aa1d3f09-19c9-44fb-926c-6b4b98b6ccb3 55301-003 HUMAN OTC DRUG Exchange Select Sport Sunscreen SPF 30 OCTINOXATE OXYBENZONE LOTION TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-004_736d70f5-e427-4e60-b6b2-0427069ece29 55301-004 HUMAN OTC DRUG Kids Flouride Rinse Sodium Fluoride RINSE ORAL 20110209 OTC MONOGRAPH FINAL part355 Your Military Exchanges SODIUM FLUORIDE .2 mg/mL N 20181231 55301-005_d55a4fd0-4745-4ad6-8ada-f22cd96ef4eb 55301-005 HUMAN OTC DRUG Exchange Select Dark Tanning Sunscreen SPF 4 OCTOCRYLENE LOTION TOPICAL 20131025 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE OCTOCRYLENE; OXYBENZONE 1; .5 g/100g; g/100g N 20181231 55301-006_216e5585-94dc-46b6-bb0c-08f085fce521 55301-006 HUMAN OTC DRUG Exchange Select Baby Sunscreen SPF 50 AVOBENZONE LOTION TOPICAL 20131007 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-007_764157c9-eb74-401e-b8aa-57504389c2c9 55301-007 HUMAN OTC DRUG Exchange Select Kids Sunscreen SPF 50 AVOBENZONE SPRAY TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-008_7fe0f16f-903e-4384-b1a1-a0c358272e88 55301-008 HUMAN OTC DRUG Exchange Select Sunscreen SPF 50 AVOBENZONE LOTION TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-009_2287e865-d8a3-4426-b994-540b32081649 55301-009 HUMAN OTC DRUG Exchange Select Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-010_3957a9ea-a3a7-497e-a5fa-be43038dd598 55301-010 HUMAN OTC DRUG Exchange Select Sport Sunscreen SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-011_f9a0eadd-1b4c-4942-a9ea-7333aa642f5d 55301-011 HUMAN OTC DRUG Exchange Select Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-012_da810782-f3ca-4126-9c70-1c24af7ad34c 55301-012 HUMAN OTC DRUG Exchange Select Sheer Dry Touch Sunscreen SPF 70 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20131021 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-013_72e1bded-4608-475f-b720-1e56e3ad8f2a 55301-013 HUMAN OTC DRUG Exchange Select Sunscreen SPF 70 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20131024 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-014_c5979230-bf93-4599-a680-e273f15fb3a3 55301-014 HUMAN OTC DRUG EXSEL SPORT SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 55301-015_085571e1-72da-48fe-aea6-09ee24d95fe4 55301-015 HUMAN OTC DRUG EXSEL SPORT SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-016_b3bc117d-9634-4e5a-8295-a84248905732 55301-016 HUMAN OTC DRUG EXSEL ALOE LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part348 ARMY AND AIR FORCE EXCHANGE SERVICE LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 55301-017_2ad125c1-76c2-40f5-a999-ed51e497d74e 55301-017 HUMAN OTC DRUG EXCEL SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g N 20181231 55301-018_41200ffd-b261-42fd-bb6b-da663166bb25 55301-018 HUMAN OTC DRUG EXCEL SPORT SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-019_0f8c1a8d-cde5-4728-9d0a-7a14c36554b4 55301-019 HUMAN OTC DRUG EXSEL SPORT SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55301-020_c0dc405e-26fb-49a6-80a5-8338eb5598bf 55301-020 HUMAN OTC DRUG EXCEL SPORT SPF 50 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 6; 4 g/100g; g/100g; g/100g N 20181231 55301-023_8addee72-ce0f-48fc-a123-7b2ecc43c73c 55301-023 HUMAN OTC DRUG Exchange Select Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160203 OTC MONOGRAPH FINAL part331 Army & Air Force Exchange Service CALCIUM CARBONATE 750 mg/1 N 20181231 55301-024_57f91553-291b-8560-e053-2991aa0a4697 55301-024 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20140818 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service MENTHOL 5.4 mg/1 N 20181231 55301-025_49b0ed96-a71b-05cf-e054-00144ff8d46c 55301-025 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20140818 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service MENTHOL 5.4 mg/1 N 20181231 55301-026_49c22e57-7498-009e-e054-00144ff8d46c 55301-026 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20140818 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service MENTHOL 7.5 mg/1 N 20181231 55301-027_4a116d5a-332d-68b6-e054-00144ff88e88 55301-027 HUMAN OTC DRUG Strawberry Cough Drop Menthol LOZENGE ORAL 20140818 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service MENTHOL 2.7 mg/1 N 20181231 55301-028_4a11d025-590e-070f-e054-00144ff88e88 55301-028 HUMAN OTC DRUG SF Menthol Cough Drop Menthol LOZENGE ORAL 20140818 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service MENTHOL 5.8 mg/1 N 20181231 55301-029_4a135762-a8fa-4140-e054-00144ff8d46c 55301-029 HUMAN OTC DRUG SF Black Cherry Cough Drops Menthol LOZENGE ORAL 20140818 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Services MENTHOL 5.8 mg/1 N 20181231 55301-030_4a149f23-76ba-04e3-e054-00144ff8d46c 55301-030 HUMAN OTC DRUG SF Honey Lemon Cough Drop Menthol LOZENGE ORAL 20140818 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Services MENTHOL 7.6 mg/1 N 20181231 55301-031_1dcd4196-4e02-4d1c-a6f3-3b9a55a1f14d 55301-031 HUMAN OTC DRUG exchange select aller ease fexofenadine hcl TABLET, FILM COATED ORAL 20151223 ANDA ANDA076447 Army & Air Force Exchange Service FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 55301-032_49d4da46-2795-53c6-e054-00144ff8d46c 55301-032 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20140818 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service MENTHOL 7.5 mg/1 N 20181231 55301-033_4a11fcf8-cb75-0cf5-e054-00144ff88e88 55301-033 HUMAN OTC DRUG SF Menthol Cough Drop Menthol LOZENGE ORAL 20140818 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Services MENTHOL 5.8 mg/1 N 20181231 55301-034_4bba6d73-2d1a-5763-e054-00144ff88e88 55301-034 HUMAN OTC DRUG cherry cold relief lozenge zinc gluconate LOZENGE ORAL 20160819 UNAPPROVED HOMEOPATHIC Army and Air Force Exchange Service ZINC GLUCONATE 2 [hp_X]/1 N 20181231 55301-035_580fcdf8-4d62-0bcf-e053-2a91aa0a8126 55301-035 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20170830 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service MENTHOL 5.8 mg/1 N 20181231 55301-036_5a3229a2-4085-6611-e053-2991aa0a3eed 55301-036 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20170927 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service MENTHOL 7.5 mg/1 N 20181231 55301-037_5d7ea09a-3ea8-f4d5-e053-2a91aa0abb08 55301-037 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20171108 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service MENTHOL 5.8 mg/1 N 20181231 55301-038_5d7f7e45-7d6a-10dc-e053-2991aa0a389c 55301-038 HUMAN OTC DRUG Sugar Free Cherry Cough Drops Menthol LOZENGE ORAL 20171108 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service MENTHOL 5.8 1/1 N 20181231 55301-039_5d8eb438-56e6-4281-e053-2a91aa0af9fb 55301-039 HUMAN OTC DRUG Sugar Free Honey Lemon Cough Drops Menthol LOZENGE ORAL 20171109 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service MENTHOL 7.6 mg/1 N 20181231 55301-043_286bad52-468b-45a8-9456-024486d2a48e 55301-043 HUMAN OTC DRUG Cold and Flu Relief Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20151231 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 55301-044_4501e75d-7de2-4260-a145-a63cfeebfad3 55301-044 HUMAN OTC DRUG Exchange Select Burn Relief Pain Relieving LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part348 ARMY AND AIR FORCE EXCHANGE SERVICE LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 55301-050_10245aee-c89d-4280-bc1e-9424658a09b2 55301-050 HUMAN OTC DRUG Exchange Select Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, FILM COATED ORAL 20150828 ANDA ANDA079113 Army & Air Force Exchange Service DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 55301-063_5426aa86-7304-4201-9885-f045ceb73009 55301-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20021029 OTC MONOGRAPH FINAL part347 For Your Military Exchange FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 55301-066_8855681d-a43e-4425-8189-e030c9c3cf90 55301-066 HUMAN OTC DRUG Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 55301-067_b7bf899c-44e5-48d6-bf8e-d843fd442432 55301-067 HUMAN OTC DRUG Exchange Select triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20160226 OTC MONOGRAPH FINAL part333B Army & Air Force Exchange Service BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 55301-069_fdd91021-8edd-4e5c-9504-c88bc2b3c7dc 55301-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20090106 OTC MONOGRAPH FINAL part347 Your Military Exchange PETROLATUM 1 g/g N 20181231 55301-072_8a321102-c3c5-4c59-9adc-2ee3ffc854e9 55301-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 20020719 OTC MONOGRAPH NOT FINAL part348 Your Military Exchange EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 55301-076_65d6ea0a-a70f-4c06-ab01-5d53461cdbb7 55301-076 HUMAN OTC DRUG Exchange select all day allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20160513 ANDA ANDA078336 Army & Air Force Exchange Service CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55301-091_01df246a-8b92-48b9-b5d0-f249ab674ac0 55301-091 HUMAN OTC DRUG Oil of Beauty Octinoxate, zinc oxide LOTION TOPICAL 20071022 OTC MONOGRAPH FINAL part352 Your Military Exchange OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 55301-092_b1bacfa8-632e-4de4-a648-7be7e06b2347 55301-092 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 55301-094_771ff5f7-f274-4479-ab52-f346eae955c1 55301-094 HUMAN OTC DRUG Hair Regrowth Treatment for Men Extra Strength minoxidil SOLUTION TOPICAL 20070517 ANDA ANDA075518 Army and Air Force Exchange Service MINOXIDIL 50 mg/mL N 20181231 55301-104_f583bca8-8d0e-4c64-8380-5d02c3559dab 55301-104 HUMAN OTC DRUG Complete Health Anticavity Fluoride Clean Mint Sodium Fluoride RINSE ORAL 20150731 OTC MONOGRAPH FINAL part355 Army & Air Force Exchange Service SODIUM FLUORIDE .0219 g/mL N 20181231 55301-117_6b043f0a-5cd6-44f6-b688-715ae07e2dc2 55301-117 HUMAN OTC DRUG Exchange Select Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120611 ANDA ANDA202319 Army & Air Force Exchange Service LANSOPRAZOLE 15 mg/1 N 20181231 55301-123_1c7f1700-69c0-4a71-8bb0-a71e3082efeb 55301-123 HUMAN OTC DRUG Exchange Select First Aid Triple Anitbiotic Pain Relieving Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20160303 OTC MONOGRAPH FINAL part333B Army & Air Force Exchange Service BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 55301-130_efa94e30-01d4-4e31-9f81-ea6f8e5aa3ff 55301-130 HUMAN OTC DRUG Undecylenic Acid Antifungal Pen LIQUID TOPICAL 20171227 OTC MONOGRAPH FINAL part333C ARMY & AIR FORCE EXCHANGE SERVICE UNDECYLENIC ACID 25 mg/1.7mL N 20181231 55301-131_647a14cd-93b3-47e0-9e75-5e7cdcb63545 55301-131 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20171227 OTC MONOGRAPH FINAL part333C ARMY & AIR FORCE EXCHANGE SERVICE TOLNAFTATE 1.5 g/150g N 20181231 55301-132_00c6ab48-1b1e-4e05-b248-5fad9ad22d6f 55301-132 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20120103 OTC MONOGRAPH FINAL part333C ARMY & AIR FORCE EXCHANGE SERVICE TOLNAFTATE 1.3 g/130g N 20181231 55301-133_5c047e34-866b-4c43-9c7c-65424409aaa0 55301-133 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid LIQUID TOPICAL 20171227 OTC MONOGRAPH FINAL part358B ARMY & AIR FORCE EXCHANGE SERVICE SALICYLIC ACID .17 mg/9mL N 20181231 55301-153_7d680f9e-937d-4ae5-ad3e-3fb3c56fe20d 55301-153 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19990126 OTC MONOGRAPH FINAL part358H Your Military Exchanges PYRITHIONE ZINC 10 mg/mL N 20181231 55301-157_02b92f8a-3abf-4613-bd9e-80df5339b5af 55301-157 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ASPIRIN 325 mg/1 N 20181231 55301-159_2e06ee81-00ed-4afe-9bc7-e4f28d498d32 55301-159 HUMAN OTC DRUG Headache Formula Extra Strength Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55301-161_0139390d-c2a3-4d81-8dbd-83fe777af16d 55301-161 HUMAN OTC DRUG Exchange Select antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160205 OTC MONOGRAPH FINAL part331 Army & Air Force Exchange Service CALCIUM CARBONATE 750 mg/1 N 20181231 55301-163_e3080611-8845-4aab-a410-bc75a5a650d1 55301-163 HUMAN OTC DRUG Anticavity Sodium Fluoride MOUTHWASH ORAL 20060129 OTC MONOGRAPH FINAL part355 Your Military Exchanges SODIUM FLUORIDE 999.5 mL/100L N 20181231 55301-174_e671ecb1-5f53-4658-8662-34de6f37111c 55301-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20151130 NDA NDA021920 AAFES/Your Military Exchanges NAPROXEN SODIUM 220 mg/1 N 20181231 55301-175_bb5bef6f-eac4-4320-b0a7-e3e4321827e8 55301-175 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN 500 mg/1 N 20191231 55301-179_e7410cb8-5be3-41e1-892e-e25ed8145478 55301-179 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL part333B Exchange Select BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 55301-180_9e287804-0ecf-4939-a6f9-beda1bfc9319 55301-180 HUMAN OTC DRUG Healing for Babies Petrolatum OINTMENT TOPICAL 20120320 OTC MONOGRAPH FINAL part347 Your Military Exchange PETROLATUM 41 kg/100kg N 20181231 55301-188_6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a 55301-188 HUMAN OTC DRUG Exchange Select Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20160304 OTC MONOGRAPH FINAL part346 Army & Air Force Exchange Service MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 55301-189_75830d66-4526-4569-a207-cd0dda47d1d1 55301-189 HUMAN OTC DRUG Sleep-Aid Diphenhydramine HCl TABLET ORAL 19900410 OTC MONOGRAPH FINAL part338 ARMY AND AIR FORCE EXCHANGE SERVICE DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55301-190_f2cd5938-46bc-40ed-935d-9f6338708799 55301-190 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55301-199_494a66d5-0ee8-4632-89d0-f5ef2101f06b 55301-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170630 ANDA ANDA078682 AAFES/Your Military Exchanges IBUPROFEN 200 mg/1 N 20181231 55301-201_1b709db3-7dc1-4756-a8a0-dddda875dc57 55301-201 HUMAN OTC DRUG Exchange Select Hydrocortisone Hydrocortisone CREAM TOPICAL 20160226 OTC MONOGRAPH NOT FINAL part348 Army & Air Force Exchange Service HYDROCORTISONE 1 g/100g N 20181231 55301-205_6cbdfb39-3a09-4734-9a7a-e584f6a2936b 55301-205 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20080204 OTC MONOGRAPH FINAL part358H Your Military Exchange COAL TAR 5 mg/mL N 20181231 55301-206_48a2f459-f28c-41e8-99c2-2429457e55a5 55301-206 HUMAN OTC DRUG EXCHANGE SELECT SPORT SPF 50 AVOBENZONE,HOMOSALATE,OCTOCRYLENE LOTION TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part352 ARMY AND AIR FORCE EXCHANGE SERVICE AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3; 10; 6 g/100g; g/100g; g/100g N 20181231 55301-210_c28e412b-16f0-456a-ad18-a57a256f40b6 55301-210 HUMAN OTC DRUG Antiseptic Eucalyptol MOUTHWASH ORAL 20101018 OTC MONOGRAPH NOT FINAL part356 Exchange Select EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L N 20181231 55301-213_d260eb73-b947-4911-9627-f7387c64b23d 55301-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20041224 OTC MONOGRAPH FINAL part355 Army + Air Force Exchange Service SODIUM FLUORIDE .05 kg/100L N 20181231 55301-220_78826970-2552-43ec-ac3e-ab301e9ec2bc 55301-220 HUMAN OTC DRUG Diaper Rash Zinc oxide CREAM TOPICAL 20150707 OTC MONOGRAPH NOT FINAL part348 Your Military Exchanges ZINC OXIDE 130 mg/g N 20181231 55301-226_00efe695-dcd6-4a0b-9ec3-f08ac004b653 55301-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 ARMY AND AIR FORCE EXCHANGE SERVICE CAFFEINE 200 mg/1 N 20181231 55301-227_2c4b4ccf-8f53-49ca-ab81-31bbab488104 55301-227 HUMAN OTC DRUG Aspirin Regular Strength Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ASPIRIN 325 mg/1 N 20181231 55301-233_a1c14cab-6a77-4b63-87df-8f131b52ff53 55301-233 HUMAN OTC DRUG Mucus Relief Cold, Flu and Sore Throat Maximum Strength Mucinex Fast Max Cold, Flu and Sore Throat Maximum Strength LIQUID ORAL 20131121 20181121 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 400; 20; 650; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 55301-234_95e68aa2-7cc5-4e37-9a1d-d19f118f1621 55301-234 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Mucinex Fast Max Severe Congestion and Cough Maximum Strength LIQUID ORAL 20131121 20181121 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 400; 20; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 55301-235_95e7799f-1edd-43d4-8443-dab7e04f1ac6 55301-235 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20191231 55301-242_96b7ba63-ae0f-4ae8-b82e-83f0fd07c623 55301-242 HUMAN OTC DRUG EZ Nite Sleep Berry ZzzQuil LIQUID ORAL 20131121 20181101 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 55301-243_26142ecf-c214-4ec0-864b-07e311311f13 55301-243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20090106 OTC MONOGRAPH FINAL part333A Your Military Exchange TRICLOSAN .15 kg/100L N 20181231 55301-248_be7c6bb5-9df7-46fe-b60b-22079dd89e26 55301-248 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090123 OTC MONOGRAPH FINAL part341 Your Military Exchanges CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg N 20181231 55301-253_5c9a3914-fd00-43a6-9796-7ed088750d6b 55301-253 HUMAN OTC DRUG Extra Strength Pain Reliever PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 20180310 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 55301-271_fdddcb3e-9edb-4478-8c35-7ba36ec47191 55301-271 HUMAN OTC DRUG exchange select acid reducer Ranitidine TABLET ORAL 20120912 ANDA ANDA076760 Army & Air Force Exchange Service RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 55301-278_920d2cbe-0ef0-43d6-9c15-8d1d5a369c7f 55301-278 HUMAN OTC DRUG Benzalkonium chloride Benzalkonium chloride 0.13% SOAP TOPICAL 20150519 OTC MONOGRAPH NOT FINAL part333A Your Military Exchanges BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 55301-279_f0440bc5-4c75-4a97-91c1-35f950f7f3c3 55301-279 HUMAN OTC DRUG Exchange Select Hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20160505 OTC MONOGRAPH FINAL part346 Army & Air Force Exchange Service COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 55301-281_b28ff5f7-ac1a-434f-bbcc-262b6d2180be 55301-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20020606 OTC MONOGRAPH FINAL part358H Your Military Exchange PYRITHIONE ZINC 10 mg/mL N 20181231 55301-282_8135396a-bff2-4554-b359-39e71e546fcf 55301-282 HUMAN OTC DRUG Pain and Fever Childrens Acetaminophen SUSPENSION ORAL 20161031 OTC MONOGRAPH NOT FINAL part343 AAFES/Your Military Exchanges ACETAMINOPHEN 160 mg/5mL N 20181231 55301-291_7ee0f952-0bad-43ee-b754-93183eef2e64 55301-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 ARMY AND AIR FORCE EXCHANGE SERVICE IBUPROFEN 200 mg/1 N 20181231 55301-292_14b657a4-c187-4423-a712-ae28459c0d84 55301-292 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 ARMY AND AIR FORCE EXCHANGE SERVICE IBUPROFEN 200 mg/1 N 20181231 55301-299_1b0cfbbc-74f4-47fb-9a8a-b89e0cd2bcfd 55301-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20100628 OTC MONOGRAPH NOT FINAL part356 Your Military Exchanges CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 55301-304_aafa9163-f08e-48c9-9ca1-7b72f67d007d 55301-304 HUMAN OTC DRUG Exchange Select Nasal oxymetazoline hydrochloride SPRAY NASAL 20111028 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 55301-306_6aca8ba5-b5ec-4766-ad65-2a80b06f2fdf 55301-306 HUMAN OTC DRUG Exchange Select ClearLax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20151008 ANDA ANDA090685 Army & Air Force Exchange Service POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 55301-311_cd1a3779-0ee6-4904-a981-071546608f66 55301-311 HUMAN OTC DRUG Everyday Clean 2 in 1 pyrithione zinc SHAMPOO TOPICAL 20040709 OTC MONOGRAPH FINAL part358H Your Military Exchanges PYRITHIONE ZINC 10 mg/10mL N 20181231 55301-314_369c01f9-c11e-4670-9932-45f02f3017d6 55301-314 HUMAN OTC DRUG EZ Nite Sleep Aid Diphenhydramine HCl LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 55301-316_488c1a12-080c-4671-aa03-1ee9da9ab9ba 55301-316 HUMAN OTC DRUG Severe cold and cough relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20151216 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55301-317_98244e83-bed7-4c79-9f54-6862cfb493fd 55301-317 HUMAN OTC DRUG Severe Cold and Cough Relief Nighttime Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride LIQUID ORAL 20151130 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55301-318_6fb9077b-fee1-42a6-b59a-6bd1ed9db09c 55301-318 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Methyl salicylate, thymol MOUTHWASH ORAL 20020708 OTC MONOGRAPH NOT FINAL part356 Your Military Exchanges EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55301-319_a9f3330c-696b-4fc2-a5c6-08ae7ba46888 55301-319 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate TABLET, CHEWABLE ORAL 19980716 OTC MONOGRAPH FINAL part335 ARMY AND AIR FORCE EXCHANGE SERVICE BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 55301-326_0c366416-b494-4242-bc8a-119788e2fc0e 55301-326 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19991025 OTC MONOGRAPH NOT FINAL part356 Your Military Exchanges EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55301-329_3662dd34-725c-4cb6-b6a4-51a1db420268 55301-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55301-334_fdaaf92a-c969-4dc5-ad1a-e57c43dd1db0 55301-334 HUMAN OTC DRUG Headache Formula Extra Strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55301-336_3912ee0f-0c80-442a-ae74-921f3ae8e40a 55301-336 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20151031 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 55301-337_2864c107-37ad-4e96-a5bd-fdcb09b70734 55301-337 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 55301-343_e76990ba-4f7a-4d7c-b71d-b2766e578d11 55301-343 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20050314 OTC MONOGRAPH NOT FINAL part348 Army and Air Force Exchange Service HYDROCORTISONE 1 g/100g E 20171231 55301-344_7896319a-e166-444e-8a5d-f0804cf6ec43 55301-344 HUMAN OTC DRUG Nite Time Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20160131 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 55301-348_b2f33835-6a7e-49dc-a9f8-faabd606c861 55301-348 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET, SUGAR COATED ORAL 20030102 OTC MONOGRAPH NOT FINAL part334 ARMY AND AIR FORCE EXCHANGE SERVICE SENNOSIDES 25 mg/1 N 20181231 55301-351_8f272080-01b9-46b7-91bd-c22636bdad1a 55301-351 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 19950921 20180727 OTC MONOGRAPH NOT FINAL part334 ARMY AND AIR FORCE EXCHANGE SERVICE DOCUSATE SODIUM 100 mg/1 E 20171231 55301-357_8931a25c-6e67-47c3-8143-bc0556e3ad17 55301-357 HUMAN OTC DRUG exchange select antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20130108 OTC MONOGRAPH FINAL part331 Army & Air Force Exchange Service ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 55301-368_6cbb6144-5270-4a79-aa42-4e60133368cc 55301-368 HUMAN OTC DRUG exchange select naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20080826 ANDA ANDA074661 Army & Air Force Exchange Service NAPROXEN SODIUM 220 mg/1 N 20181231 55301-369_2848db06-dc38-4fad-b242-158f881f9aea 55301-369 HUMAN OTC DRUG MENSTRUAL RELIEF MAXIMUM STRENGTH Acetaminophen, Pamabrom, Pyrilamine maleate TABLET, FILM COATED ORAL 20000620 20190119 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 E 20171231 55301-370_cab09851-0c00-4571-ad2b-ff9b35ff6375 55301-370 HUMAN OTC DRUG Advanced Ethyl Alcohol GEL TOPICAL 20120927 OTC MONOGRAPH NOT FINAL part333A Your Military Exchanges ALCOHOL 70 mL/100mL N 20181231 55301-372_2cb8ae9b-e47c-443f-987b-d8757122c046 55301-372 HUMAN OTC DRUG Pink Bismuth Regular Strength Bismuth subsalicylate LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part335 AAFES/Your Military Exchanges BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 55301-373_a96ca8cc-eeb9-4aba-89ce-d03ccf23c59c 55301-373 HUMAN OTC DRUG Pain Relief Medicine PM Acetaminophen and Diphenhydramine Citrate TABLET ORAL 20040607 20180629 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 E 20171231 55301-375_f692197e-8cf8-4b8e-814b-ff5d78b982a7 55301-375 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 ARMY AND AIR FORCE EXCHANGE SERVICE LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 55301-379_1318800d-2b9c-4d6a-a17d-b42fdbc923b0 55301-379 HUMAN OTC DRUG Body Menthol POWDER TOPICAL 20131130 OTC MONOGRAPH NOT FINAL part348 Exchange Select MENTHOL 1.5 mg/g N 20181231 55301-382_f049b5c8-4348-4a69-8f50-e43703924b3b 55301-382 HUMAN OTC DRUG Tussin Multi Symptom Cold CF Adult Dextromethorphan HBr, Guaifenesin, Phenylephrine LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 55301-384_9c55d719-29f2-428b-ad82-7477ca49b0ca 55301-384 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM Sugar Free Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 55301-385_b6edb7a9-130e-42d3-90e8-9fb4574c6938 55301-385 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM Adult Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 55301-386_93d18fb5-4779-48f9-8a6c-068a123b8d1f 55301-386 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 ARMY AND AIR FORCE EXCHANGE SERVICE DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 55301-388_6543018a-1b38-449a-8114-600fa8d5c36f 55301-388 HUMAN OTC DRUG Exchange Select Nasal Oxymetazoline HCl SPRAY NASAL 20140106 OTC MONOGRAPH FINAL part341 Army & Air Force Exchange Service OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 55301-392_b75f18eb-7b75-4626-aa18-17d507c43733 55301-392 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020330 ANDA ANDA075139 ARMY AND AIR FORCE EXCHANGE SERVICE IBUPROFEN 200 mg/1 N 20181231 55301-393_9317a00b-4ff4-470d-ac91-2d4c265e65f0 55301-393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020408 ANDA ANDA075139 ARMY AND AIR FORCE EXCHANGE SERVICE IBUPROFEN 200 mg/1 N 20181231 55301-403_fc92c622-dbe5-482b-830b-b790121b2b4b 55301-403 HUMAN OTC DRUG Motion Sickness Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 ARMY AND AIR FORCE EXCHANGE SERVICE MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 55301-406_9c34c498-6110-4c1e-9311-823753ca0702 55301-406 HUMAN OTC DRUG Exchange Select Cold Sore Treatment Benzalkonium Chloride CREAM TOPICAL 20110804 OTC MONOGRAPH NOT FINAL part333A Army + Air Force Exchange Service BENZALKONIUM CHLORIDE 1.3 mg/g N 20181231 55301-411_3edc641c-4c60-45f6-8825-658076861754 55301-411 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr TABLET, SUGAR COATED ORAL 20030503 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 55301-428_73ab8825-0318-488d-87b2-bdf007c71e75 55301-428 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING BUCCAL 20140101 ANDA ANDA078699 Army and Air Force Exchange Service NICOTINE 2 mg/1 N 20181231 55301-429_73ab8825-0318-488d-87b2-bdf007c71e75 55301-429 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING BUCCAL 20140101 ANDA ANDA078697 Army and Air Force Exchange Service NICOTINE 4 mg/1 N 20181231 55301-434_c9c4a182-ed64-4bcc-93a0-5051c6446428 55301-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130826 OTC MONOGRAPH NOT FINAL part356 Your Military Exchange EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55301-439_887dd652-2939-43a2-83a3-97cedb7ea850 55301-439 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20130429 OTC MONOGRAPH NOT FINAL part333A Your Military Exchanges ALCOHOL 616 mL/mL N 20181231 55301-442_de107683-f90e-42a0-96c4-477e18be5889 55301-442 HUMAN OTC DRUG Adult Tussin Cough Gels Dextromethorphan HBr CAPSULE, GELATIN COATED ORAL 20060424 20180827 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 E 20171231 55301-446_523f5723-f649-4776-a1e0-779f272456dc 55301-446 HUMAN OTC DRUG Sinus Headache and Pain Day, Non-drowsy Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55301-447_b5235361-5d71-4850-88fb-d8a90b833997 55301-447 HUMAN OTC DRUG Acetaminophen Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050203 20201128 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN 80 mg/1 N 20191231 55301-450_8c729b9d-0c2e-4592-84ea-2b44c42040d1 55301-450 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN 160 mg/1 N 20181231 55301-453_763aef00-688b-4b9a-9456-ed92ebd0a768 55301-453 HUMAN OTC DRUG Suphedrine PE Congestion Non-Drowsy Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20191231 55301-455_054bbb68-cdbe-4ca5-b5be-ef46db04151c 55301-455 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl TABLET, FILM COATED ORAL 20050628 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 55301-462_96c3039d-e0bc-483c-bbd2-3cee03e3cc1e 55301-462 HUMAN OTC DRUG Suphedrine PE Sinus plus Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 55301-464_5de51568-3143-47f5-8aed-e58698f1f935 55301-464 HUMAN OTC DRUG Allergy and Sinus Headache Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED ORAL 20050615 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 55301-466_b1438957-495d-4a16-9f1e-5e0adcd67e49 55301-466 HUMAN OTC DRUG Sinus Congestion and Pain Non-Drowsy, Daytime Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 20190903 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55301-470_02b8ebf4-91c8-4b48-84f1-5ed8b9f74fcc 55301-470 HUMAN OTC DRUG Cold Multi-Symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20050715 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55301-500_e30f8675-2598-41be-aa33-563c30580b14 55301-500 HUMAN OTC DRUG Pre-moistened Medicated WipesHemorrhoidal wipeHemorrhoidal wipeHemorrhoidal wipeHemorrhoidal wipe Hemorrhoidal wipes with witch hazel witch hazel CLOTH TOPICAL 20130701 OTC MONOGRAPH FINAL part346 ARMY AND AIR FORCE EXCHANGE SERVICE WITCH HAZEL 129 g/258g N 20181231 55301-502_081e3f9f-e197-423f-b56d-8de2cbaffed9 55301-502 HUMAN OTC DRUG Suphedrine PE Pressure plus Pain Maximum Strength, Non-Drowsy Acetaminophen, Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55301-503_89273c15-ea87-490a-a94c-2753efd59098 55301-503 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING BUCCAL 20140101 ANDA ANDA079044 Army and Air Force Exchange Service NICOTINE 2 mg/1 N 20181231 55301-504_89273c15-ea87-490a-a94c-2753efd59098 55301-504 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING BUCCAL 20140101 ANDA ANDA079038 Army and Air Force Exchange Service NICOTINE 4 mg/1 N 20181231 55301-506_f15d5c04-e308-4540-8c0a-d66a44c3d4fd 55301-506 HUMAN OTC DRUG exchange select allergy relief Fluticasone propionate SPRAY, METERED NASAL 20171027 ANDA ANDA207957 Army & Air Force Exchange Service FLUTICASONE PROPIONATE 50 ug/1 N 20181231 55301-519_5b973f3c-10e1-4ee8-9ed5-758512218562 55301-519 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN 500 mg/1 N 20181231 55301-525_cce01881-8df7-45f8-9787-3b89669843f8 55301-525 HUMAN OTC DRUG Aphedrid Cold and Allergy Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20050722 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 55301-527_7d40ddf8-92e8-4789-a6bc-8a0e09438210 55301-527 HUMAN OTC DRUG Sinus Congestion and Pain Severe Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 55301-529_7e058a1b-1623-485c-98d1-08d13b076f10 55301-529 HUMAN OTC DRUG Cold Multi-Symptom Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE N 20181231 55301-532_c36f043e-0ab0-4df6-b877-ba04e5e753da 55301-532 HUMAN OTC DRUG Mucus Relief Maximum Strength Guaifenesin TABLET, FILM COATED ORAL 20051222 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE GUAIFENESIN 400 mg/1 N 20181231 55301-533_392416d5-9f80-4b30-9e44-9d7ecd8841c9 55301-533 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr and Guaifenesin TABLET, FILM COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 55301-534_76752c0a-52c3-4667-ad10-b7e5c7960a2d 55301-534 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070919 20180727 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 55301-535_39832b8f-7246-45cf-b92b-6d0ec18cec28 55301-535 HUMAN OTC DRUG Cold and Flu Relief Multi-Symptom, Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20070910 20180727 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 E 20171231 55301-543_e71e4eeb-7ef8-4c40-9bce-5f73aa0b223a 55301-543 HUMAN OTC DRUG NiteTime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20171231 OTC MONOGRAPH FINAL part341 AAFES/Your Military Exchanges ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20191231 55301-551_e9ba7021-8cb8-48aa-9540-e40e8b72b386 55301-551 HUMAN OTC DRUG Medicated Menthol, zinc oxide POWDER TOPICAL 20030910 OTC MONOGRAPH NOT FINAL part348 Your Military Exchange MENTHOL; ZINC OXIDE 1.5; 10 mg/g; mg/g N 20181231 55301-556_7a6d1989-aff7-463b-b60d-6afcefa0d582 55301-556 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55301-557_75ae427a-7d9c-4d7b-ba81-df95f4bdceb4 55301-557 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55301-559_8b2fec19-1ea5-477d-9e2e-688ea717e03d 55301-559 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate TABLET ORAL 20080327 20200817 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 55301-560_7fb5049c-e022-4d2a-91a7-2b2dc765eac6 55301-560 HUMAN OTC DRUG Cold Multi-Symptom Non-Drowsy, Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20080329 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55301-573_9f0356fd-457e-4451-bb54-ca6fb593a129 55301-573 HUMAN OTC DRUG Cold and Flu Severe, Day and Nighttime Acetaminophen,Chlorpheniramine maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl KIT 20050804 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE N 20181231 55301-590_c3d0efbf-efcf-425d-a033-652c983c3529 55301-590 HUMAN OTC DRUG Exchange Select Allergy Relief Cetirizine Hydrochloride TABLET ORAL 20140206 ANDA ANDA078336 Army & Air Force Exchange Service CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55301-595_811760bc-863b-426b-8ac2-902773380e9b 55301-595 HUMAN OTC DRUG Exchange Select antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20160304 OTC MONOGRAPH FINAL part331 Army & Air Force Exchange Service CALCIUM CARBONATE 1000 mg/1 N 20181231 55301-600_dc720605-7726-4ae8-8775-79c1111cc829 55301-600 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ASPIRIN 81 mg/1 N 20181231 55301-602_cf35a8a0-f56a-4938-8e9d-68277fe840d4 55301-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20021218 OTC MONOGRAPH NOT FINAL part334 Your Military Exchange MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 55301-608_6a1a523b-3fcf-41af-adcb-156a13199a1d 55301-608 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone TABLET, CHEWABLE ORAL 20130701 OTC MONOGRAPH FINAL part332 ARMY AND AIR FORCE EXCHANGE SERVICE DIMETHICONE 125 mg/1 N 20181231 55301-612_7cbda586-dc3d-4de7-919d-def9c7f4bee3 55301-612 HUMAN OTC DRUG exchange select allergy relief Loratadine TABLET ORAL 20080826 ANDA ANDA076301 Army & Air Force Exchange Service LORATADINE 10 mg/1 N 20181231 55301-615_b19c1d52-e050-49e2-a032-af3d4bafabfc 55301-615 HUMAN OTC DRUG Cold and Sinus Maximum Strength, Multi-Symptom Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130630 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 55301-618_f806b86f-2fed-4ea0-9fa7-19b997701209 55301-618 HUMAN OTC DRUG Cold, Flu and Sore Throat Maximum Strength, Multi-Symptom Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55301-619_5d6c475a-664c-4c2e-b49a-40ddd85761ce 55301-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 20110406 OTC MONOGRAPH FINAL part347 Your Military Exchanges DIMETHICONE 1.3 kg/100mL N 20181231 55301-623_e6fcb794-dcf0-4b1f-8d2e-81867647b365 55301-623 HUMAN OTC DRUG Womens Gentle Laxative Bisacodyl TABLET, COATED ORAL 20050212 20181214 OTC MONOGRAPH NOT FINAL part334 ARMY AND AIR FORCE EXCHANGE SERVICE BISACODYL 5 mg/1 E 20171231 55301-654_64b8b4c2-7c08-4d2d-8491-695b2e2be5c8 55301-654 HUMAN OTC DRUG Sleep Aid Nighttime Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH FINAL part338 ARMY AND AIR FORCE EXCHANGE SERVICE DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55301-655_f069b0aa-cb13-4cdb-92a9-202d9afd1a49 55301-655 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH NOT FINAL part334 ARMY AND AIR FORCE EXCHANGE SERVICE DOCUSATE SODIUM 100 mg/1 N 20181231 55301-658_76caf0c2-513d-42af-b1b3-be238c97bbe4 55301-658 HUMAN OTC DRUG Allergy Relief Dye-Free Liquid Gels Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55301-659_7ed00005-bc2f-49f2-8b2f-bb634422f6e5 55301-659 HUMAN OTC DRUG Cold and Flu Relief Non-Drowsy, DayTime, Multi-Symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55301-660_8a750521-9464-4c47-bd22-de1887ff2d17 55301-660 HUMAN OTC DRUG Cold and Flu Relief NightTime, Multi-symptom Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 55301-661_a8751e12-d7b8-4263-980b-77cf7b8afee8 55301-661 HUMAN OTC DRUG Tussin Cough Gels Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 55301-664_dc004079-cac7-4dee-b723-bdcc0fd6fedc 55301-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20020709 OTC MONOGRAPH NOT FINAL part356 Your Military Exchanges EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55301-667_94f98e46-31c2-4c7c-a537-30284dfd339e 55301-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20120123 OTC MONOGRAPH FINAL part334 Your Military Exchange MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 55301-676_88b5a7bd-f439-47f6-9734-215a78c24ac5 55301-676 HUMAN OTC DRUG Laxative Bisacodyl TABLET, COATED ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 ARMY AND AIR FORCE EXCHANGE SERVICE BISACODYL 5 mg/1 N 20181231 55301-679_551ede3b-eef5-4ad6-b90b-b77c942d479f 55301-679 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Pamabrom, Pyrilamine Maleate TABLET, FILM COATED ORAL 20151113 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 55301-689_7a70a6f5-5602-4c68-9854-5103d5bf2992 55301-689 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr TABLET, COATED ORAL 20170331 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 55301-692_b88f3b1b-9c52-4695-8ee1-958981346238 55301-692 HUMAN OTC DRUG Exchange Select Cool Heat Menthol, Methyl salicylate CREAM TOPICAL 20160523 OTC MONOGRAPH NOT FINAL part348 Army & Air Force Exchange Service MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 55301-730_b6f28a47-28c6-4292-bfc2-62cbe55a1fd8 55301-730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20020712 ANDA ANDA074164 Exchange Select MICONAZOLE NITRATE 2 g/100g E 20171231 55301-810_2a470e6e-f375-4425-9140-ed19cc6faa3f 55301-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20100408 OTC MONOGRAPH NOT FINAL part333A Your Military Exchanges ISOPROPYL ALCOHOL 500 mg/mL N 20181231 55301-821_92cd0a58-e707-41b3-b61d-850d98d4933b 55301-821 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ASPIRIN 81 mg/1 N 20181231 55301-822_955d7ca8-d0dd-458e-a16c-48609f78081b 55301-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20021029 OTC MONOGRAPH FINAL part347 Your Military Exchanges WITCH HAZEL 86 kg/100L N 20181231 55301-823_4aa3f7e6-b256-4f80-b39a-3ed7fc9def90 55301-823 HUMAN OTC DRUG Triple Antibiotic Plus Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hcl OINTMENT TOPICAL 20050301 OTC MONOGRAPH FINAL part333B Exchange Select BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g E 20171231 55301-831_eeff7150-b91c-4fd3-b6fa-1d41fc15f291 55301-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 20150605 OTC MONOGRAPH NOT FINAL part334 Your Military Exchanges MINERAL OIL 999 mg/mL N 20181231 55301-845_fc28e6eb-0cd8-409d-ad88-6fbd9d6adf52 55301-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20150626 OTC MONOGRAPH FINAL part344 Your Military Exchanges ISOPROPYL ALCOHOL 613 mg/mL N 20181231 55301-852_3d87b57a-e34a-4101-b605-f2a89b55b475 55301-852 HUMAN OTC DRUG Exchange Select Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20140106 ANDA ANDA091429 Army & Air Force Exchange Service RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 55301-857_d6689115-bf1f-4e09-8a16-a40d5ceebdf6 55301-857 HUMAN OTC DRUG Exchange Select Atheletes foot Clotrimazole CREAM TOPICAL 20160407 OTC MONOGRAPH FINAL part333C Army & Air Force Exchange Service CLOTRIMAZOLE 1 g/100g N 20181231 55301-871_450192a1-c6c6-42fe-9cf8-3a0f51e2c33b 55301-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20021010 OTC MONOGRAPH NOT FINAL part333A Army + Air Force Exchange Service HYDROGEN PEROXIDE .3 kg/100L N 20181231 55301-875_fb070b44-7666-483a-95ab-138ba4dd7376 55301-875 HUMAN OTC DRUG Salicylic Acid Astringent LIQUID TOPICAL 20090605 OTC MONOGRAPH FINAL part333D Your Military Exchanges SALICYLIC ACID 5 mg/mL N 20181231 55301-898_5fa9089f-90d1-48b6-bb79-c6171eeeaa03 55301-898 HUMAN OTC DRUG Exchange Select Esomeprazole Magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20171204 ANDA ANDA207193 Exchange Select ESOMEPRAZOLE 20 mg/1 N 20191231 55301-901_a8f920b8-9756-48de-8008-8fc12a8b8604 55301-901 HUMAN OTC DRUG Cold and Flu Multi-Symptom Daytime Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20131101 20180727 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE E 20171231 55301-915_5303d433-adba-4fdd-98ec-1e872e9d225f 55301-915 HUMAN OTC DRUG exchange select omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20081028 NDA NDA022032 Army & Air Force Exchange Service OMEPRAZOLE 20 mg/1 N 20181231 55301-916_ac116802-351f-433e-a325-02afea38ef95 55301-916 HUMAN OTC DRUG Exchange Select Miconazole 1 Miconazole nitrate KIT 20160325 ANDA ANDA079114 Army & Air Force Exchange Service N 20181231 55301-939_497df1ad-c032-474f-aae4-1235f7e6f6cd 55301-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Army & Air Force Exchange Service CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55301-941_db2a2da4-1dff-48d5-84e8-83fefdfcafa1 55301-941 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20140728 OTC MONOGRAPH NOT FINAL part333A Your Military Exchange BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55301-947_a937cad2-e8ce-486a-8164-e2c2f5d171ce 55301-947 HUMAN OTC DRUG Oil Free Acne Wash Salicylic Acid 2% LOTION TOPICAL 20090514 OTC MONOGRAPH FINAL part333D Your Military Exchanges SALICYLIC ACID 20.6 mg/mL N 20181231 55301-973_7897e4d6-3cd6-4647-a35e-bb57d07bbed2 55301-973 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Diphenhydramine citrate TABLET, FILM COATED ORAL 20030607 20200220 OTC MONOGRAPH NOT FINAL part343 ARMY AND AIR FORCE EXCHANGE SERVICE ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 N 20181231 55301-992_06e6f568-580b-4243-b74c-9fcbe4be1c78 55301-992 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20010913 20180727 OTC MONOGRAPH FINAL part336 ARMY AND AIR FORCE EXCHANGE SERVICE DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 55301-999_dafb6bbf-7a80-4cda-b140-d59291e2123b 55301-999 HUMAN OTC DRUG Cold and Flu Relief Multi-Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20150301 OTC MONOGRAPH FINAL part341 ARMY AND AIR FORCE EXCHANGE SERVICE N 20191231 55305-111_ae5c7e38-d112-4ff3-8757-aac3dc864848 55305-111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20131230 OTC MONOGRAPH NOT FINAL part333E Aero Healthcare ALCOHOL .665 g/mL N 20181231 55305-112_491f8433-bcf2-4545-8974-3094fa5b4a29 55305-112 HUMAN OTC DRUG Aerowash Eyewash and Skin-Rinse purified water SOLUTION OPHTHALMIC 20150501 OTC MONOGRAPH FINAL part349 Aero Healthcare WATER 98.577 mL/100mL E 20171231 55305-113_b8073b11-106e-48b0-b2a8-37f01e18ba9d 55305-113 HUMAN OTC DRUG Aeroaid Antiseptic First Aid benzocaine and benzethonium chloride AEROSOL, SPRAY TOPICAL 20140820 OTC MONOGRAPH NOT FINAL part348 Aero Healthcare, LLC. BENZOCAINE; BENZETHONIUM CHLORIDE 3825; 76.5 mg/85g; mg/85g E 20171231 55305-114_5c18bb44-43ee-4f35-8f1a-6fde76f3dd79 55305-114 HUMAN OTC DRUG Aerowound Blood Clotting First Aid benzethonium chloride and lidocaine AEROSOL, SPRAY TOPICAL 20140820 OTC MONOGRAPH NOT FINAL part348 Aero Healthcare, LLC. LIDOCAINE; BENZETHONIUM CHLORIDE 756.5; 76.5 mg/85g; mg/85g E 20171231 55305-116_d0e2594d-82eb-47d1-992d-c22824c639cf 55305-116 HUMAN OTC DRUG Aeroburn Burn First Aid benzethonium chloride, benzocaine, and menthol AEROSOL, SPRAY TOPICAL 20140820 OTC MONOGRAPH NOT FINAL part348 Aero Healthcare, LLC. BENZETHONIUM CHLORIDE; BENZOCAINE; MENTHOL 170; 8500; 281 mg/85g; mg/85g; mg/85g E 20171231 55305-118_40e59587-d2b1-2d22-e054-00144ff88e88 55305-118 HUMAN OTC DRUG Aerowipe Anstiseptic Wipe SWAB TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Aero Healthcare BENZALKONIUM CHLORIDE .1 g/100g E 20171231 55305-120_34c93704-9f3d-6746-e054-00144ff8d46c 55305-120 HUMAN OTC DRUG Aerowipe Alcohol Wipe SWAB TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Aero Healthcare ISOPROPYL ALCOHOL .7 mL/mL E 20171231 55305-123_58ffb850-d58f-0dc0-e053-2a91aa0a1015 55305-123 HUMAN OTC DRUG Aerosoothe Triple Antibiotic Ointment OINTMENT TOPICAL 20151020 OTC MONOGRAPH FINAL part333B Aero Healthcare US LLC POLYMYXIN B SULFATE; BACITRACIN ZINC; NEOMYCIN SULFATE 5000; 400; 5 [iU]/g; [iU]/g; mg/g N 20181231 55305-124_45aad3a4-dc7f-4b51-e054-00144ff88e88 55305-124 HUMAN OTC DRUG AEROCLEANSE Instant Hand Sanitizer Instant Hand Sanitizer GEL TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part333A Aero Healthcare ALCOHOL 62 g/100g N 20181231 55305-125_40ccb938-eeb6-318e-e054-00144ff88e88 55305-125 HUMAN OTC DRUG Aerowipe Sting Relief Pad SWAB TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Aero Healthcare BENZOCAINE; ISOPROPYL ALCOHOL 6; 6 mg/100mL; mg/100mL E 20171231 55310-001_92cccc28-94a8-4b0d-9d46-94b1b7374e7d 55310-001 HUMAN OTC DRUG Assured Isopropyl Alcohol PATCH TOPICAL 20130104 OTC MONOGRAPH NOT FINAL part333A SHANGHAI YINJING MEDICAL SUPPLIES CO., LTD. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 55310-002_68198485-2b8e-410b-8fa8-dd947697d2b4 55310-002 HUMAN OTC DRUG moist wipes BENZALKONIUM CHLORIDE LOTION TOPICAL 20160615 OTC MONOGRAPH NOT FINAL part333A Shanghai Yinjing Medical Supplies Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 55310-003_6908ec03-66dd-4ba9-95a9-e1cfc1bec352 55310-003 HUMAN OTC DRUG Acne Wipes SALICYLIC ACID SWAB TOPICAL 20160720 OTC MONOGRAPH FINAL part333D Shanghai Yinjing Medical Supplies Co., Ltd. SALICYLIC ACID .5 g/100mL N 20181231 55310-004_65343a52-ff48-4898-8258-0c4ba9ba064e 55310-004 HUMAN OTC DRUG moist wipes BENZALKONIUM CHLORIDE LOTION TOPICAL 20160726 OTC MONOGRAPH NOT FINAL part333A Shanghai Yinjing Medical Supplies Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 55312-000_5930aae2-0c91-4643-aa0b-001a7e8b3411 55312-000 HUMAN OTC DRUG Western Family Broad Spectrum Sunscreen SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 WESTERN FAMILY FOODS, INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55312-001_5eba8937-d359-45ca-95d0-14e1a9b9a95e 55312-001 HUMAN OTC DRUG Stool Softener plus Stimulant Laxative Docusate sodium and Sennosides TABLET ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 55312-002_4e7842b0-6393-55e0-e054-00144ff88e88 55312-002 HUMAN OTC DRUG WESTERN FAMILY Alcohol Swabs ISOPROPYL ALCOHOL LIQUID TOPICAL 20120114 20180310 OTC MONOGRAPH NOT FINAL part333A Western Family Foods, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 55312-003_e9de92b1-628f-4d40-b8f9-e4957827d8c7 55312-003 HUMAN OTC DRUG Western Family Complete Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE 2.43 mg/g E 20171231 55312-004_8a60cb2f-5646-4a11-aa2b-1d1ce6dbca63 55312-004 HUMAN OTC DRUG Anti Cavity Rinse Sodium Fluoride RINSE ORAL 20090512 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE .05 kg/100L N 20181231 55312-005_5a94acc7-f3a3-42e2-b88e-f1751d391dbf 55312-005 HUMAN OTC DRUG Western Family Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part352 WESTERN FAMILY FOODS, INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55312-006_1f1f76f1-ff31-416b-9b27-86ea2ab8a56b 55312-006 HUMAN OTC DRUG Western Family Broad Spectrum SunscreenSPF 50 SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part352 WESTERN FAMILY FOODS, INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55312-007_d45b3eca-ca25-4cff-a003-5444c782662d 55312-007 HUMAN OTC DRUG Western Family Baby Broad Spectrum Sunscreen SPF 50 AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part352 WESTERN FAMILY FOODS, INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55312-012_b0650448-ef6f-4cc1-9771-8d3eaead739b 55312-012 HUMAN OTC DRUG Western Family Aloe Vera Moisturizing LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part348 WESTERN FAMILY FOODS, INC. LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 55312-013_9a843f34-91ab-4890-b92d-73e0a8916f57 55312-013 HUMAN OTC DRUG Western Family HydroCortisone Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Western Family Foods Inc HYDROCORTISONE 1 g/100g N 20181231 55312-015_e7236d55-23f7-4f0e-b0a7-1e6cb3d636d8 55312-015 HUMAN OTC DRUG WESTERN FAMILY OIL FREE FACES SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part352 WESTERN FAMILY FOODS, INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55312-016_4de1990f-fe21-44ef-8946-3846a862584b 55312-016 HUMAN OTC DRUG Senna- S Docusate sodium and Sennosides TABLET ORAL 20130301 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 55312-017_192ccbf8-52eb-4781-9465-d3b7c430d803 55312-017 HUMAN OTC DRUG Western FAMILY SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part352 WESTERN FAMILY FOODS, INC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 55312-019_20b27f52-3a1b-4ec6-bb95-19988139a685 55312-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120724 ANDA ANDA202727 Western Family Foods, Inc. LANSOPRAZOLE 15 mg/1 E 20171231 55312-020_2fa9bdb6-7cc0-4093-8631-cc6e084e79cd 55312-020 HUMAN OTC DRUG Western Family Antifungal Tolnaftate CREAM TOPICAL 20060217 OTC MONOGRAPH FINAL part333C Western Family Foods Inc TOLNAFTATE 10 mg/g N 20181231 55312-029_41cb30ff-aec3-48ae-9086-f4a488f4a478 55312-029 HUMAN OTC DRUG Epsom Salt MAGNESIUM SULFATE GRANULE ORAL 19980605 OTC MONOGRAPH NOT FINAL part334 Western Family MAGNESIUM SULFATE HEPTAHYDRATE 100 kg/100kg N 20181231 55312-034_843b7897-d103-43eb-bcb1-2a3841c1ac8a 55312-034 HUMAN OTC DRUG WESTERN FAMILY HEMORRHOIDAL MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL OINTMENT TOPICAL 20120731 OTC MONOGRAPH FINAL part346 WESTERN FAMILY FOOD, INC. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 719; 2.5 mg/g; mg/g; mg/g E 20171231 55312-035_7823fa33-13ad-492e-842e-af3f5ca88cd9 55312-035 HUMAN OTC DRUG Western Family Hemorrhoidal Mineral Oil OINTMENT TOPICAL 20130630 OTC MONOGRAPH FINAL part346 Western Family Food, Inc. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/100g; mg/100g; mg/100g E 20171231 55312-036_1af3d3dd-74a1-49ce-9b7a-2a6adf19f74b 55312-036 HUMAN OTC DRUG Mucus Relief Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 55312-037_36b75c20-29e0-4825-9e98-91cf21f2d017 55312-037 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 55312-038_22ed89f2-e311-4389-926b-8533372921c7 55312-038 HUMAN OTC DRUG Cough Relief Grape Cough Suppressant Dextromethorphan HBr LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 55312-039_05ffb18c-b16c-4537-81e7-56f1b36f620a 55312-039 HUMAN OTC DRUG Cough Relief Cough Suppressant Dextromethorphan HBr LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 55312-041_d38a1a48-8729-4eb7-894b-b93e04dea37c 55312-041 HUMAN OTC DRUG Night Relief Free acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090915 OTC MONOGRAPH FINAL part341 Western Family Foods inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 55312-051_25a2f2e1-429a-4753-9ee2-8be917481cc0 55312-051 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 20140228 OTC MONOGRAPH FINAL part340 Western Family Foods, Inc. CAFFEINE 200 mg/1 N 20181231 55312-053_b2f1c850-5157-4b73-b008-9a4dae2c4bb5 55312-053 HUMAN OTC DRUG Western Family Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part348 Western Family Food, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g E 20171231 55312-054_b8c8c43d-7c7f-430f-afe6-6d8427dd2221 55312-054 HUMAN OTC DRUG Western Family Pain Relieving Camphor CREAM TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Western Family Food, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE .04; .1; .3 g/g; g/g; g/g E 20171231 55312-055_24c50480-0f51-47a4-bd13-822c52fafcc1 55312-055 HUMAN OTC DRUG Western Family Benzalkonium chloride CLOTH TOPICAL 20130530 OTC MONOGRAPH NOT FINAL part333A Western Family Foods Inc BENZALKONIUM CHLORIDE .115 g/1 N 20181231 55312-063_487d7e98-cead-45d5-b338-9df3d93e2e96 55312-063 HUMAN OTC DRUG Western Family HydroCortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Western Family Foods Inc HYDROCORTISONE 1 g/100g N 20181231 55312-065_8db3a7d8-8b5f-414e-937f-95a8ac6f502b 55312-065 HUMAN OTC DRUG Nasal D Oxymetazoline Hydrochloride SPRAY NASAL 20141117 OTC MONOGRAPH FINAL part341 Western Family Foods Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 55312-066_4c7a0db5-b460-4b20-a26b-dafd69900075 55312-066 HUMAN OTC DRUG DayRelief Multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 55312-069_f978d7ec-1fe2-423d-9adf-d7b48e336c84 55312-069 HUMAN OTC DRUG Pure petroleum White Petrolatum JELLY TOPICAL 19900215 OTC MONOGRAPH FINAL part347 Western Family Foods, Inc PETROLATUM 1 g/g N 20181231 55312-071_947a67ff-0a58-4a36-8d85-76589938293a 55312-071 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part335 Western Family Foods, Inc. BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 55312-072_3fcb7279-b0b0-40dd-afb8-769a5514e837 55312-072 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL MOUTHWASH ORAL 19951114 OTC MONOGRAPH NOT FINAL part348 Western Family Foods, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 55312-075_bfdd52d4-a967-45b4-9366-290311438c51 55312-075 HUMAN OTC DRUG Western Family Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Western Family Foods Inc BACITRACIN ZINC 500 [iU]/g N 20181231 55312-076_e8acab5d-80cb-4e9e-a523-5115399e39f6 55312-076 HUMAN OTC DRUG Western Family Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Western Family Foods Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 55312-077_c83b0fd9-e5af-4c0c-a3b5-06cf191d81a0 55312-077 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130301 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ASPIRIN 81 mg/1 N 20181231 55312-078_9804236a-8a22-4c78-80ce-23429d80d045 55312-078 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Western Family Foods, Inc. ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 55312-092_56dbc128-2638-4e66-b01d-10394e177073 55312-092 HUMAN OTC DRUG Western Family Childrens Allergy Relief Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Western Family Foods Inc LORATADINE 5 mg/5mL N 20181231 55312-100_5e2d4c4e-59a5-4e44-b371-6f87e37da495 55312-100 HUMAN OTC DRUG Day Relief Sinus PE Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120710 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55312-101_d54dd319-3ad7-48ce-99d9-03972b2b4fd3 55312-101 HUMAN OTC DRUG Night Relief sinus Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120712 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 55312-103_d9f98d57-37bc-4816-b9e4-46c75c109e0e 55312-103 HUMAN OTC DRUG Aspirin enteric safety coated Aspirin TABLET ORAL 20120104 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ASPIRIN 81 mg/1 N 20181231 55312-104_ecdf369d-0b20-4ac9-ad42-e0dbcd6d2fee 55312-104 HUMAN OTC DRUG Aspirin Safety Coated Aspirin TABLET, COATED ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ASPIRIN 81 mg/1 N 20181231 55312-106_7eff942d-f18e-498c-abcf-0bcb46834644 55312-106 HUMAN OTC DRUG Western Family Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Western Family Foods Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 55312-107_1a9a45b1-6b16-4569-bc8c-f02a8489bd66 55312-107 HUMAN OTC DRUG Expectorant Guaifenesin TABLET ORAL 20100701 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. GUAIFENESIN 400 mg/1 N 20181231 55312-109_102145c7-2e61-4504-8dc9-e35b8a857d88 55312-109 HUMAN OTC DRUG Expectorant Tab DM Dextromethorphan Hydrobromide and Guaifenesin TABLET ORAL 20100705 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 55312-111_2340c82e-75ce-466b-a796-33ee3673920a 55312-111 HUMAN OTC DRUG Western Family Saline Laxative ENEMA RECTAL 20131216 OTC MONOGRAPH NOT FINAL part334 WESTERN FAMILY HOLDING COMPANY SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 55312-118_dbc0ea13-ee84-4753-94a5-441809c20491 55312-118 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110201 ANDA ANDA072199 Western Family Foods, Inc. IBUPROFEN 200 mg/1 N 20181231 55312-120_22ee7424-21fb-4a02-98b1-db1d230aeae0 55312-120 HUMAN OTC DRUG WOMENS LAXATIVE Bisacodyl TABLET, COATED ORAL 20100705 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. BISACODYL 5 mg/1 N 20181231 55312-153_723d6804-ff72-400e-b0ee-661092893a31 55312-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Western Family Foods, Inc PYRITHIONE ZINC 1 kg/100L N 20181231 55312-158_63096f4e-6f42-4006-9252-5b2330b6912f 55312-158 HUMAN OTC DRUG Western Family Sensitive Whitening Fluoride Potassium Nitrate and Sodium Fluoride PASTE, DENTIFRICE DENTAL 20070502 OTC MONOGRAPH NOT FINAL part356 Western Family Food, Inc. POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g E 20171231 55312-162_4baccc50-7a20-4e0a-85b7-528b2973ff6a 55312-162 HUMAN OTC DRUG Western Family Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE 2.43 mg/g E 20171231 55312-163_0b18bfbf-a029-4f60-8e4e-817f01da2b61 55312-163 HUMAN OTC DRUG Western Family Tartar Control Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE 2.43 mg/g E 20171231 55312-164_62798515-110d-472f-a027-11cc75387654 55312-164 HUMAN OTC DRUG Western Family Cavity Control Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE 2.43 mg/g E 20171231 55312-167_b32609ab-e49e-4e8e-8323-63288b9ed366 55312-167 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110201 ANDA ANDA072199 Western Family Foods, Inc. IBUPROFEN 200 mg/1 N 20181231 55312-173_fd7e5d68-1b37-47a0-8c79-696305337114 55312-173 HUMAN OTC DRUG lice Piperonyl Butoxide, Pyrethrum Extract KIT 20071029 OTC MONOGRAPH FINAL part358G Western Family Foods Inc N 20181231 55312-174_66f87383-7bca-45b0-ab6b-6551bb7e6535 55312-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141231 NDA NDA021920 Western Family Foods, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 55312-180_c6920875-91dc-45ae-8934-a06014804ee0 55312-180 HUMAN OTC DRUG Senna Natural vegetable laxative SENNOSIDES TABLET ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. SENNOSIDES 8.6 mg/1 N 20181231 55312-181_57fc357d-bde5-42e6-b063-266a3d22cd37 55312-181 HUMAN OTC DRUG Senna Natural vegetable laxative SENNOSIDES TABLET ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. SENNOSIDES 8.6 mg/1 N 20181231 55312-182_7f6d7336-dcd2-43d1-a252-8d778d2f320b 55312-182 HUMAN OTC DRUG Western Family Whitening Plus Minty Fresh Mouthwash Anticavity Sodium Fluoride PASTE, DENTIFRICE DENTAL 20081124 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE 2.43 mg/g E 20171231 55312-183_e72d4cf5-6aca-4d1f-a1e2-e95181b1bb04 55312-183 HUMAN OTC DRUG Complete Menstrual Relief Acetaminophen, Caffeine, Pyrilamine maleate TABLET ORAL 20120416 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 55312-184_385ad5a4-e083-45a2-bea2-30895c011d9d 55312-184 HUMAN OTC DRUG Headache relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET ORAL 20120619 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55312-190_4c5bb484-1b2c-4bc9-8ce7-6dba63bdee53 55312-190 HUMAN OTC DRUG Gentle and Effective Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20130308 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. BISACODYL 5 mg/1 N 20181231 55312-197_bbb997ec-ae9d-4362-a978-cca5bcead33d 55312-197 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100313 ANDA ANDA078682 Western Family Foods, Inc. IBUPROFEN 200 mg/1 N 20181231 55312-198_3c08ca4a-6c45-4fbc-997e-020ebe6bcd18 55312-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20140930 ANDA ANDA078682 Western Family Foods, Inc. IBUPROFEN 200 mg/1 N 20181231 55312-200_6e950757-d8b8-416d-a57d-f6e64e19a326 55312-200 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET ORAL 20100712 OTC MONOGRAPH FINAL part336 Western Family Foods, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55312-205_68ac47db-a3c4-4c14-8351-e5a1c2bc8400 55312-205 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20111201 OTC MONOGRAPH FINAL part358H Western Family Foods COAL TAR 2.5 mL/100L N 20181231 55312-210_99760c9b-8644-4bdd-b5e4-6f2ddb32b90e 55312-210 HUMAN OTC DRUG Tartar Control Eucalyptol MOUTHWASH ORAL 20100923 OTC MONOGRAPH NOT FINAL part356 Western Family EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 mL/100L; mL/100L; mL/100L; mL/100L N 20181231 55312-211_2f61cfd8-0a34-4873-98d3-995c8140e92c 55312-211 HUMAN OTC DRUG Allergy Relief Cetirizine HCl CAPSULE ORAL 20131230 NDA NDA022429 Western Family Foods, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55312-213_0888b51e-a5cc-43ff-8d52-cb04fe282fa3 55312-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20031020 OTC MONOGRAPH FINAL part355 Western Family Foods, Inc SODIUM FLUORIDE .05 kg/100L N 20181231 55312-216_b91b617f-7ecd-4e76-88c9-6310c564d3b3 55312-216 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20111215 ANDA ANDA079174 Western Family Foods, Inc. IBUPROFEN 200 mg/1 N 20181231 55312-218_7ddacf90-6468-4342-837c-fe4330f5a7ea 55312-218 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20120705 ANDA ANDA079174 Western Family Foods, Inc. IBUPROFEN 200 mg/1 N 20181231 55312-219_1a920216-a516-4d5d-8632-aa22c8f84e86 55312-219 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110901 ANDA ANDA079174 Western Family Foods, Inc. IBUPROFEN 200 mg/1 N 20181231 55312-230_74abcd7f-6851-4d68-bfbb-be0c60d743e3 55312-230 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20100701 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 55312-232_f4f9ef15-2032-46f9-ab0a-723816793ab8 55312-232 HUMAN OTC DRUG Mucus Relief DM Max Maximum Strength Mucinex DM Max Maximum Strength LIQUID ORAL 20131030 20180430 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/20mL; mg/20mL N 20181231 55312-233_a6976bf9-d8fa-48fb-95d8-52500ceff3fd 55312-233 HUMAN OTC DRUG Mucus Relief Cold, Flu and Sore Throat Maximum Strength Mucinex Cold, Flu and Sore Throat Maximum Strength LIQUID ORAL 20131106 20180430 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 400; 20; 650; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 55312-235_615168a2-2755-4503-83b3-16cdd4ea84ac 55312-235 HUMAN OTC DRUG Mucus Relief Cold and Sinus Maximum Strength Mucinex Cold and Sinus Maximum Strength LIQUID ORAL 20131029 20180430 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. GUAIFENESIN; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 400; 650; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 55312-236_acd6f557-4206-44da-a012-d6acb60ae094 55312-236 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 55312-238_ea256a30-784b-42dc-bc49-e00a7a0a0395 55312-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130815 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 55312-242_f00e53c3-e1aa-4dc8-9bcd-fb07418799d3 55312-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part347 Western Family Foods, Inc. DIMETHICONE 125 mg/1 N 20181231 55312-247_ae84a768-b224-4889-8af5-6a62e1c62071 55312-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140131 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55312-248_ec9fa0af-b0b9-440f-a619-c6b098e1bb16 55312-248 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20131130 ANDA ANDA079174 Western Family Foods, Inc. IBUPROFEN 200 mg/1 N 20181231 55312-250_9ac890c6-3e78-4c47-8194-7b23e0a9a579 55312-250 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 20100701 OTC MONOGRAPH FINAL part340 Western Family Foods, Inc. CAFFEINE 200 mg/1 N 20181231 55312-252_3fc63701-c6aa-4bdd-855c-f1c1d92956cc 55312-252 HUMAN OTC DRUG Sleep Nighttime Sleep Aid DIPHENHYDRAMINE HCL TABLET ORAL 20140228 OTC MONOGRAPH FINAL part338 Western Family Foods, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55312-259_45ba545f-e73c-48c3-8cde-9af0e747b5cf 55312-259 HUMAN OTC DRUG Aspirin adult low strength Aspirin TABLET, CHEWABLE ORAL 20010918 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ASPIRIN 81 mg/1 N 20181231 55312-268_0321efcf-0b06-4431-bc91-945ea8fe871f 55312-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part356 Western Family Foods, Inc. HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 55312-275_d872c41f-692f-4dac-a918-7afe85c684b2 55312-275 HUMAN OTC DRUG Rubbing Alcohol 70 percent Isopropyl Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Western Family Foods, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 55312-276_e2852a6c-9a2e-4901-910a-f65bea3f4fbd 55312-276 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 Percent Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Western Family Foods, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 55312-281_1f7c6bd6-56e2-42fb-849c-8ac2a9ca9f81 55312-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20020614 OTC MONOGRAPH FINAL part358H Western Family PYRITHIONE ZINC 10 mg/mL N 20181231 55312-288_ef595a90-b3dc-4c85-9868-2415825cf095 55312-288 HUMAN OTC DRUG Pain Reliever Childrens Acetaminophen SUSPENSION ORAL 20150731 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 55312-296_aa253423-c67b-440c-84b7-7b6606247232 55312-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 19980710 OTC MONOGRAPH FINAL part358H Western Family Foods Inc PYRITHIONE ZINC 10 mg/mL N 20181231 55312-304_7040b3af-3395-41c6-8f13-229b072b49f8 55312-304 HUMAN OTC DRUG nasal d original oxymetazoline hydrochloride SPRAY NASAL 20141113 OTC MONOGRAPH FINAL part341 Western Family Foods Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 55312-305_790aadd8-4f31-48b4-9d86-4a4799d9eb93 55312-305 HUMAN OTC DRUG Western Family Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Western Family Foods Inc CLOTRIMAZOLE 10 mg/g N 20181231 55312-306_9b9ead9b-b2cb-4a4e-9921-c75c56c42720 55312-306 HUMAN OTC DRUG Laxative Clear Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091024 ANDA ANDA090685 Western Family Foods Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 55312-309_5d8fda79-2ae1-4920-b24c-2db6d2a9ebc6 55312-309 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20061114 OTC MONOGRAPH FINAL part358H Western Family Foods, Inc PYRITHIONE ZINC 1 g/100mL N 20181231 55312-311_6debae54-cc17-44a9-bb20-725ab0297cc4 55312-311 HUMAN OTC DRUG Everyday Clean Pyrithione zinc SHAMPOO TOPICAL 20070207 OTC MONOGRAPH FINAL part358H Western Family Foods, Inc PYRITHIONE ZINC 1 g/100mL N 20181231 55312-317_8850ffb4-7c69-4aa0-8ffe-46672883bb26 55312-317 HUMAN OTC DRUG Flu Relief Therapy Nighttime Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55312-318_be7b5982-e688-4ffc-904a-e57afb0e3499 55312-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 19960614 OTC MONOGRAPH NOT FINAL part356 Western Family Foods, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 55312-326_7e8372c9-71bc-4216-91be-4f289102fdb0 55312-326 HUMAN OTC DRUG Magnesium Citrate Cherry Magnesium citrate LIQUID ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 55312-332_702a9072-d371-4519-8ba2-60bb20fdb393 55312-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19921104 OTC MONOGRAPH NOT FINAL part334 Western Family Foods Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 55312-336_f762a599-7f9c-4d69-9d38-7af7b5ef6777 55312-336 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150131 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 650; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 55312-355_9af5c9d2-da26-49c2-8bea-dbed51ee344b 55312-355 HUMAN OTC DRUG added strength pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19971125 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55312-372_8c79e8fe-5ce2-4b00-8d6c-3c85b9f92c33 55312-372 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20150131 OTC MONOGRAPH FINAL part335 Western Family Foods, Inc. BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 55312-376_3685e338-22bf-4921-8578-b55fd06c6794 55312-376 HUMAN OTC DRUG Sore Throat Relief Phenol LIQUID ORAL 20140630 OTC MONOGRAPH NOT FINAL part356 Western Family Foods, Inc. PHENOL 1.4 g/100mL N 20181231 55312-377_ca963258-dbb9-4d8e-9ee7-1a139fc625bb 55312-377 HUMAN OTC DRUG Sore Throat Relief Phenol LIQUID ORAL 20140630 OTC MONOGRAPH NOT FINAL part356 Western Family Foods, Inc. PHENOL 1.4 g/100mL N 20181231 55312-382_f4780f99-b478-4775-8250-2202fb89dedc 55312-382 HUMAN OTC DRUG Tussin CF Adult Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 55312-385_6d6d9e64-782e-4ccf-a3f9-e5d274f10eb5 55312-385 HUMAN OTC DRUG Tussin DM Adult Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 55312-390_a5514f39-ab7b-43f2-a699-b946e20878cb 55312-390 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20141031 OTC MONOGRAPH FINAL part347 Western Family Foods, Inc. WITCH HAZEL 842 mg/mL N 20181231 55312-396_3d5b343f-f834-4130-8194-8b26096b44d8 55312-396 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19921104 OTC MONOGRAPH NOT FINAL part334 Western Family Foods Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 55312-407_82399c57-1874-4b76-9969-bbd27c18a6d4 55312-407 HUMAN OTC DRUG Western Family Cold Sore Treatment Camphor CREAM TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part348 Western Family Foods Inc BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 55312-426_8461a952-c007-403b-9792-cf976881df81 55312-426 HUMAN OTC DRUG Tioconazole 1 Tioconazole OINTMENT VAGINAL 20160601 ANDA ANDA075915 Western Family Foods Inc TIOCONAZOLE 6.5 g/100g N 20181231 55312-440_09fe0264-2ad2-4ff2-8e1e-17fae705044f 55312-440 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, DELAYED RELEASE ORAL 20120104 OTC MONOGRAPH FINAL part343 Western Family Foods, Inc. ASPIRIN 81 mg/1 N 20181231 55312-444_62716807-7255-424f-b2bb-5f271d3c18c8 55312-444 HUMAN OTC DRUG Antacid Ultra Strength Calcium Carbonate TABLET, CHEWABLE ORAL 20140421 OTC MONOGRAPH FINAL part331 Western Family Foods Inc CALCIUM CARBONATE 1000 mg/1 N 20181231 55312-467_69ffac02-37e7-4699-b6c2-4c5ac00c2f03 55312-467 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19930330 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ASPIRIN 81 mg/1 N 20181231 55312-469_263388c7-5033-49c2-9e57-70f2fddea65a 55312-469 HUMAN OTC DRUG Effervescent Pain Relief Aspirin, Citric Acid Monohydrate, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20080128 OTC MONOGRAPH FINAL part343 Western Family Foods, Inc. ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 E 20171231 55312-475_a56aadfb-541e-47d4-a664-4c1fda298faa 55312-475 HUMAN OTC DRUG Allergy Childrens Cetirizine HCl SOLUTION ORAL 20160711 ANDA ANDA204226 Western Family Foods Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 55312-483_53918239-43f2-425b-85e5-272f5f2a61e1 55312-483 HUMAN OTC DRUG Allergy Relief Dye Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150930 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55312-484_dcc3064d-8c3b-46b4-af14-5672501c7bb3 55312-484 HUMAN OTC DRUG acetaminophen extra strength Acetaminophen TABLET ORAL 20080314 OTC MONOGRAPH NOT FINAL part343 Western Family Foods Inc ACETAMINOPHEN 500 mg/1 N 20181231 55312-500_6423670a-5ae2-4e82-b39d-bdabc07be7d2 55312-500 HUMAN OTC DRUG Western Family Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Western Family Foods Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 55312-504_c65c1293-c635-438e-8b8b-1c8c86c8b30a 55312-504 HUMAN OTC DRUG Western Family Triple Antibiotic plus Pain Relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20120331 OTC MONOGRAPH FINAL part333B Western Family Foods Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 55312-515_30fe2bbe-3acc-4abc-a979-c61543dabd72 55312-515 HUMAN OTC DRUG day relief night relief sinus pe Acetaminophen, Doxylamine succinate , Phenylephrine HCl KIT 20071116 OTC MONOGRAPH FINAL part341 Western Family Foods Inc N 20181231 55312-520_d9869610-4bd3-4992-bc86-196b69eec387 55312-520 HUMAN OTC DRUG Anti-Diarrheal loperamide HCl LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100705 NDA NDA021855 Western Family Foods, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 55312-530_b5465b5d-bfeb-4f2d-ae6f-01bc2483e9d2 55312-530 HUMAN OTC DRUG Antigas ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20100701 OTC MONOGRAPH FINAL part332 Western Family Foods, Inc. DIMETHICONE 180 mg/1 N 20181231 55312-550_ca4b2541-6b71-4fb4-9a6f-dda326e8c6dd 55312-550 HUMAN OTC DRUG AntiGas Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100313 OTC MONOGRAPH FINAL part332 Western Family Foods, Inc. DIMETHICONE 125 mg/1 N 20181231 55312-608_cf397780-379f-4d0f-876e-2115d902658b 55312-608 HUMAN OTC DRUG Childrens mucus relief Dextromethorphan hbr, Guaifenesin SOLUTION ORAL 20150728 OTC MONOGRAPH FINAL part341 Western Family Foods Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 55312-630_ac3b8372-4ada-41db-b2be-90b43a68619c 55312-630 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 20100701 OTC MONOGRAPH FINAL part336 Western Family Foods, Inc. DIMENHYDRINATE 50 mg/1 N 20181231 55312-664_f3cf68b1-8c55-44a6-998b-a2340829277e 55312-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19980315 OTC MONOGRAPH NOT FINAL part356 Western Family Foods, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55312-666_47b52859-208a-4c00-9fbb-13a1d7351ef1 55312-666 HUMAN OTC DRUG cold and cough Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060223 OTC MONOGRAPH FINAL part341 Western Family Foods Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 55312-667_09916a32-cae1-4894-8da9-008a0516544c 55312-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 19900415 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 55312-685_f477b9d1-77f5-40f4-85dd-c86b2ff7f57a 55312-685 HUMAN OTC DRUG childrens ibuprofen Ibuprofen LIQUID ORAL 20080818 ANDA ANDA074937 Western Family Foods Inc IBUPROFEN 100 mg/5mL N 20181231 55312-720_af3da19e-df3a-46ff-8215-f121a8e6362d 55312-720 HUMAN OTC DRUG Complete Allergy Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20131230 OTC MONOGRAPH FINAL part336 Western Family Foods, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55312-733_080fc67a-e4a7-4675-abc1-ef3833683674 55312-733 HUMAN OTC DRUG NightRelief DayRelief acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20120202 OTC MONOGRAPH FINAL part341 Western Family Foods Inc N 20181231 55312-776_1fd2a412-d654-4caa-b66a-ce7689e005cc 55312-776 HUMAN OTC DRUG Western Family Hygienic Cleansing Witch Hazel CLOTH TOPICAL 20150710 OTC MONOGRAPH FINAL part346 Western Family Foods, Inc WITCH HAZEL .5 g/1 N 20181231 55312-777_baf5bebc-f089-47c6-96da-9c02b5215263 55312-777 HUMAN OTC DRUG Western Family Hemorrhoidal Medicated Witch Hazel CLOTH TOPICAL 20150709 OTC MONOGRAPH FINAL part346 Western Family Foods, Inc WITCH HAZEL 129 g/258g N 20181231 55312-778_21334731-d2e3-48da-af96-88f91ca62c4a 55312-778 HUMAN OTC DRUG Acne Wash Western Family Salicylic Acid 2% LIQUID TOPICAL 20111011 OTC MONOGRAPH FINAL part333D Western Family SALICYLIC ACID 2 g/100mL N 20181231 55312-817_55b080ec-34fb-4707-afb9-d504b883897a 55312-817 HUMAN OTC DRUG nasal d oxymetazoline hydrochloride SPRAY NASAL 20150126 OTC MONOGRAPH FINAL part341 Western Family Foods Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 55312-822_5d6e9f16-269b-4d67-a040-41428390e156 55312-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19961125 OTC MONOGRAPH FINAL part347 Western Family Foods, Inc WITCH HAZEL 86 kg/100L N 20181231 55312-831_fa0e2b62-2741-4605-b625-59e53b13184f 55312-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 19940901 OTC MONOGRAPH NOT FINAL part334 Western Family Foods, Inc. MINERAL OIL 999 mg/mL N 20181231 55312-871_e1f04313-583a-4351-9ae0-acd6368e4a19 55312-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19900315 OTC MONOGRAPH NOT FINAL part333A Western Family HYDROGEN PEROXIDE .3 kg/100L N 20181231 55312-890_568ecc44-a44d-4d13-8a5d-231d3d7be661 55312-890 HUMAN OTC DRUG Allerfed Cold and Allergy PE Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20100705 OTC MONOGRAPH FINAL part341 Western Family Foods, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 55312-926_966481cb-7352-4e99-b5a3-67c80947acda 55312-926 HUMAN OTC DRUG Day Relief Night Relief Free Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20070817 OTC MONOGRAPH FINAL part341 Western Family Foods Inc N 20181231 55312-947_2fa4be84-d0ce-48d2-9d90-8cb0b13c1fb8 55312-947 HUMAN OTC DRUG Menstrual relief maximum strength ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE TABLET ORAL 20100705 OTC MONOGRAPH NOT FINAL part343 Western Family Foods, Inc. ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 55312-950_28b84ae2-63a0-44e8-8c53-e0ad3b6c77b1 55312-950 HUMAN OTC DRUG acid relief Ranitidine TABLET, FILM COATED ORAL 20111003 ANDA ANDA091429 Western Family Foods Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 55315-002_0f306fdd-c38f-4d2f-8ae2-c5eb94e99462 55315-002 HUMAN OTC DRUG Childrens Cold and Allergy Brompheniramine maleate and Phenylephrine HCl SOLUTION ORAL 20151215 OTC MONOGRAPH FINAL part341 Fred's, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL N 20181231 55315-003_469b51ca-4778-4366-8e00-6805fcb1469b 55315-003 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride LIQUID ORAL 20131023 OTC MONOGRAPH FINAL part338 fred's, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL E 20171231 55315-004_d773c939-b959-4dff-8a82-b085f2acb32c 55315-004 HUMAN OTC DRUG Night Time Severe Cold and Cough Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl SYRUP ORAL 20160609 OTC MONOGRAPH FINAL part341 Fred's, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55315-005_99550ace-08dc-4995-a219-7812c87a8dbb 55315-005 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE ORAL 20130315 OTC MONOGRAPH NOT FINAL part334 Freds Inc DOCUSATE SODIUM 100 mg/1 N 20181231 55315-006_731794cf-725f-451a-bfb9-b7045e25d34b 55315-006 HUMAN OTC DRUG DAYTIME SEVERE COLD AND COUGH acetaminophen, dextromethorphan hbr and phenylephrine hcl SYRUP ORAL 20160609 OTC MONOGRAPH FINAL part341 Fred's, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55315-007_bb88a224-859f-42c5-a9b3-4536784a3ca5 55315-007 HUMAN OTC DRUG Cetirizine Hydrochloride (Allergy Relief) Cetirizine Hydrochloride TABLET ORAL 20150805 ANDA ANDA090760 Fred's, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55315-019_899ee4ee-6eca-4003-bbd2-a946582387c9 55315-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20121204 ANDA ANDA202727 Freds Inc LANSOPRAZOLE 15 mg/1 N 20181231 55315-020_48fae1ec-1591-3cfb-e054-00144ff88e88 55315-020 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20140203 OTC MONOGRAPH FINAL part341 Fred's Inc. MENTHOL 5.4 mg/1 N 20181231 55315-021_492163a4-9992-1c6d-e054-00144ff8d46c 55315-021 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20140203 OTC MONOGRAPH FINAL part341 Fred's Inc. MENTHOL 5.4 mg/1 N 20181231 55315-022_499a2f53-9a34-4fe8-e054-00144ff8d46c 55315-022 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20140203 OTC MONOGRAPH FINAL part341 Fred's Inc. MENTHOL 5.8 mg/1 N 20181231 55315-023_499a7164-77c5-582b-e054-00144ff8d46c 55315-023 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20140203 OTC MONOGRAPH FINAL part341 Fred's Inc. MENTHOL 5.8 mg/1 N 20181231 55315-024_499c0c5f-cf03-3dde-e054-00144ff88e88 55315-024 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20140203 OTC MONOGRAPH FINAL part341 Fred's Inc. MENTHOL 7.5 mg/1 N 20181231 55315-025_499c2627-204e-3ddb-e054-00144ff88e88 55315-025 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20140203 OTC MONOGRAPH FINAL part341 Fred's Inc. MENTHOL 7.5 mg/1 N 20181231 55315-026_49ad90f8-f354-3dc5-e054-00144ff8d46c 55315-026 HUMAN OTC DRUG Strawberry Cough Drop Menthol LOZENGE ORAL 20140203 OTC MONOGRAPH FINAL part341 Fred's Inc. MENTHOL 2.7 mg/1 N 20181231 55315-027_49ae15b9-bced-3aed-e054-00144ff88e88 55315-027 HUMAN OTC DRUG SF Menthol Cough Drop Menthol LOZENGE ORAL 20140203 OTC MONOGRAPH FINAL part341 Fred's Inc. MENTHOL 5.8 mg/1 N 20181231 55315-028_49af17f1-136b-1662-e054-00144ff8d46c 55315-028 HUMAN OTC DRUG SF Cherry Cough Drop Menthol LOZENGE ORAL 20140203 OTC MONOGRAPH FINAL part341 Fred's Inc. MENTHOL 5.8 mg/1 N 20181231 55315-029_625b19c6-32a7-7e70-e053-2991aa0a3bae 55315-029 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20180109 OTC MONOGRAPH FINAL part341 Freds MENTHOL 5.4 mg/1 N 20191231 55315-030_625be3ed-9bb0-f65d-e053-2a91aa0adc6b 55315-030 HUMAN OTC DRUG Menthol cough drops menthol LOZENGE ORAL 20180109 OTC MONOGRAPH FINAL part341 Freds MENTHOL 5.4 mg/1 N 20191231 55315-031_625cb5c0-e428-dc54-e053-2a91aa0a5892 55315-031 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20180109 OTC MONOGRAPH FINAL part341 Freds MENTHOL 5.8 mg/1 N 20191231 55315-032_625dd485-45b1-4872-e053-2a91aa0a3238 55315-032 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20180109 OTC MONOGRAPH FINAL part341 Freds MENTHOL 5.8 mg/1 N 20191231 55315-033_62727d79-c39e-3e84-e053-2a91aa0a45f1 55315-033 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20180110 OTC MONOGRAPH FINAL part341 Freds MENTHOL 7.5 mg/1 N 20191231 55315-034_62734519-6c36-1448-e053-2991aa0a61aa 55315-034 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20180110 OTC MONOGRAPH FINAL part341 Freds MENTHOL 7.5 mg/1 N 20191231 55315-035_82c3ae93-e78a-413d-a298-fd33a51e236f 55315-035 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100625 ANDA ANDA090283 Fred's Inc. FAMOTIDINE 10 mg/1 N 20181231 55315-036_638a4a36-e48d-7999-e053-2a91aa0a7f30 55315-036 HUMAN OTC DRUG Strawberry Cough Drops Menthol LOZENGE ORAL 20180124 OTC MONOGRAPH FINAL part341 Freds MENTHOL 2.7 mg/1 N 20191231 55315-037_638aedd9-97af-4f3c-e053-2991aa0a301a 55315-037 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20180124 OTC MONOGRAPH FINAL part341 Freds MENTHOL 5.8 mg/1 N 20191231 55315-038_638cbc92-296c-cbae-e053-2991aa0aef46 55315-038 HUMAN OTC DRUG Sugar Free Cherry Cough Drops Menthol LOZENGE ORAL 20180124 OTC MONOGRAPH FINAL part341 Freds MENTHOL 5.8 mg/1 N 20191231 55315-047_8f81242e-a616-4029-a6d0-e328f4e58862 55315-047 HUMAN OTC DRUG Cold Head Congestion Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20050715 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55315-050_5df4686c-e0e1-670d-e053-2991aa0a0c3a 55315-050 HUMAN OTC DRUG Freds Antiseptic Instant Pain Relief Camphor 10.8% and Phenol 4.7% LIQUID TOPICAL 20171109 OTC MONOGRAPH NOT FINAL part348 Fred's, Inc CAMPHOR (NATURAL); PHENOL 108; 47 mg/mL; mg/mL N 20181231 55315-060_97abc3db-1424-4307-8ba2-54ee87d305c2 55315-060 HUMAN OTC DRUG NON ASPIRIN PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20151217 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55315-066_1d66f2ae-4533-40f6-89df-0791c38b24f9 55315-066 HUMAN OTC DRUG Cold and Flu Daytime Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 55315-069_b957ebd0-4e2b-4460-969a-f6310642db3e 55315-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20141108 OTC MONOGRAPH FINAL part347 Fred's Inc PETROLATUM 1 g/g N 20181231 55315-070_bc1f4485-722c-4b31-9d95-972e6743f6a8 55315-070 HUMAN OTC DRUG Stomach Relief Cherry Bismuth subsalicylate LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part335 Freds Inc BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 55315-082_f44e2eed-a76e-4293-857e-c2109e542578 55315-082 HUMAN OTC DRUG Pain and Fever Childrens Acetaminophen SUSPENSION ORAL 20171231 OTC MONOGRAPH NOT FINAL part343 Freds Inc ACETAMINOPHEN 160 mg/5mL N 20191231 55315-091_46761892-adbf-2370-e054-00144ff88e88 55315-091 HUMAN OTC DRUG Rest Simply DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20080901 OTC MONOGRAPH FINAL part338 Freds, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55315-092_f7b6607a-1922-4a41-9cea-e06d6b0265f9 55315-092 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part341 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 55315-099_2daad0c9-377c-4599-baa8-fadc7efa7b17 55315-099 HUMAN OTC DRUG Day Time Sinus Pain Reliever, Nasal Decongestant Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120815 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55315-101_5df43cdd-928b-2868-e053-2991aa0ac410 55315-101 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20120510 20190531 OTC MONOGRAPH NOT FINAL part343 FREDS, INC ACETAMINOPHEN 500 mg/1 N 20181231 55315-102_d5a14933-4166-40bc-82a9-0c6dd0997453 55315-102 HUMAN OTC DRUG Night Time Sinus Acetaminophen, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121205 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 55315-103_e393e616-e4ca-4dd8-86dd-1902425ce1b5 55315-103 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH NOT FINAL part343 Freds Inc ASPIRIN 81 mg/1 N 20181231 55315-104_8679a049-8bad-4fa2-9797-55a73e908284 55315-104 HUMAN OTC DRUG Aspirin Safety coated Aspirin TABLET, COATED ORAL 20140831 OTC MONOGRAPH NOT FINAL part343 Freds Inc ASPIRIN 81 mg/1 N 20181231 55315-105_68a2b937-1c9b-45cd-bd45-e194f6ae332f 55315-105 HUMAN OTC DRUG Pain Reliever Regular Strength Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN 325 mg/1 N 20181231 55315-110_9fdb4653-5b43-4cde-b0fc-ea71010bbcd1 55315-110 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100301 OTC MONOGRAPH NOT FINAL part334 Freds Inc DOCUSATE SODIUM 100 mg/1 N 20181231 55315-113_46762967-8225-6e21-e054-00144ff8d46c 55315-113 HUMAN OTC DRUG Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20080901 OTC MONOGRAPH FINAL part341 Freds, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55315-118_39f6f573-e51d-4669-8273-3ef195025762 55315-118 HUMAN OTC DRUG FREDS ADVANCED EYE DROPS DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL SOLUTION OPHTHALMIC 20121015 OTC MONOGRAPH FINAL part349 FREDS, INC DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55315-123_7229ffc2-3b67-495e-bf7d-c42f8f6e7e8f 55315-123 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Fred's Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 55315-124_8d7ee5f2-5b40-413e-b286-8d969907d0a6 55315-124 HUMAN OTC DRUG Freds Astringent Rdeness Reliever Eye TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20130630 OTC MONOGRAPH FINAL part349 Freds Inc TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .05; .25 mg/mg; mg/mg N 20181231 55315-125_8d96eb67-39ec-4b76-8409-118f6721bb58 55315-125 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION ORAL 20120222 20180810 ANDA ANDA079058 Fred's Inc. IBUPROFEN 50 mg/1.25mL N 20181231 55315-129_1428cd10-5f4a-4ba5-a730-a313e04c5d0d 55315-129 HUMAN OTC DRUG Cetirizine HCL 10 mg All Day Allergy Relief Cetirizine Hydrochloride TABLET ORAL 20130301 ANDA ANDA078780 Freds Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55315-135_79c4d5b9-f20b-48e8-8894-40ba990f3ee6 55315-135 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN 500 mg/1 N 20181231 55315-140_efb5146b-aee3-4555-a7e0-4fce2335fbb5 55315-140 HUMAN OTC DRUG Laxative pills maximum strength Sennosides TABLET ORAL 20100708 OTC MONOGRAPH NOT FINAL part334 Freds Inc SENNOSIDES 25 mg/1 N 20181231 55315-148_e76bcdb2-8954-40c5-9861-065584b0b07f 55315-148 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN 500 mg/1 N 20181231 55315-157_972eb896-5b33-4e94-9d7d-b025841928ff 55315-157 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ASPIRIN 325 mg/1 N 20181231 55315-159_4e2ace39-5fb4-444b-8667-1335d84d10a2 55315-159 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55315-163_9fd57f9c-c1ce-4aba-9991-874ecdff33a8 55315-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20120628 OTC MONOGRAPH FINAL part355 Fred's Inc SODIUM FLUORIDE .1 mg/mL N 20181231 55315-165_c990bff4-e0fc-43ff-a450-d875d37ee294 55315-165 HUMAN OTC DRUG Ibuprofen PM Ibuprofen and Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20110610 ANDA ANDA090397 Freds Inc IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE 200; 25 mg/1; mg/1 E 20171231 55315-168_57554cac-fbeb-4c89-98c8-81cb392e5ea0 55315-168 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20150930 ANDA ANDA079096 Freds Inc NAPROXEN SODIUM 220 mg/1 N 20181231 55315-169_52b380eb-95c4-4cde-8aed-2b4ffa15c18a 55315-169 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20150930 ANDA ANDA079096 Freds Inc NAPROXEN SODIUM 220 mg/1 N 20181231 55315-179_3e8629a6-d125-4edb-9484-ae24feb3f2a2 55315-179 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate OINTMENT TOPICAL 20090501 OTC MONOGRAPH FINAL part333B Fred's Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 55315-183_f257009b-1f46-4580-a004-c55ed4b361b3 55315-183 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20121015 OTC MONOGRAPH NOT FINAL part343 Freds Inc ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 55315-184_4f306fac-ab73-4901-9ebd-ae97f3029e93 55315-184 HUMAN OTC DRUG ANTIBACTERIAL FOAMING FRESH PEAR TRICLOSAN LIQUID TOPICAL 20110708 OTC MONOGRAPH NOT FINAL part333E FRED'S INC TRICLOSAN .46 mL/100mL N 20181231 55315-185_c6aa50b8-8560-480f-8af5-6cce5e883904 55315-185 HUMAN OTC DRUG FREDS ANTIBACTERIAL FRESH PEAR TRICLOSAN LIQUID TOPICAL 20120925 OTC MONOGRAPH NOT FINAL part333E FREDS INC. TRICLOSAN .46 mg/100mL N 20181231 55315-189_4a8fb507-0f9b-4423-b35d-98a393da4fdd 55315-189 HUMAN OTC DRUG Somnitabs Diphenhydramine HCl TABLET ORAL 19900410 OTC MONOGRAPH FINAL part338 FRED'S, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55315-190_c3553c4f-9b27-4ded-be5b-78c034290f3f 55315-190 HUMAN OTC DRUG Laxative Bisacodyl TABLET, COATED ORAL 20100708 OTC MONOGRAPH NOT FINAL part334 Freds Inc BISACODYL 5 mg/1 N 20181231 55315-199_5695f5d4-65f1-4692-a547-6fe85ded3880 55315-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130413 ANDA ANDA078682 Freds Inc IBUPROFEN 200 mg/1 N 20181231 55315-211_b7d3d62f-871a-487c-9609-d1644aeaf638 55315-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20130801 NDA NDA022429 Freds Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20191231 55315-218_ba119bb7-205f-4eb1-a9e8-142d401fa16d 55315-218 HUMAN OTC DRUG Aspirin Chewable, Low Dose Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ASPIRIN 81 mg/1 N 20181231 55315-225_a87f0d80-f176-4bf6-8d97-fc2080c4dff0 55315-225 HUMAN OTC DRUG Nighttime Sleep Aid Non Habit Forming Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130411 OTC MONOGRAPH FINAL part341 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55315-226_71f3b113-b42c-4d83-b35e-a298fafdea61 55315-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 FRED'S, INC. CAFFEINE 200 mg/1 N 20181231 55315-227_fc050377-da40-468a-b7df-d92fd9da6088 55315-227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130308 OTC MONOGRAPH FINAL part343 Freds Inc ASPIRIN 81 mg/1 N 20181231 55315-229_62119158-7ea2-4ec4-b356-b6e45e9823f2 55315-229 HUMAN OTC DRUG Non-Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20100708 OTC MONOGRAPH FINAL part338 Freds Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55315-230_b28bff2b-7a85-4b6b-96a1-192ce3c1f4fd 55315-230 HUMAN OTC DRUG Sleep-Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20130315 OTC MONOGRAPH FINAL part341 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 55315-236_9854ace3-215a-4a9e-8b59-e54c3cda601e 55315-236 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 55315-238_92855cbb-ed6a-43b6-a40d-df0fede577d1 55315-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 Freds Inc DOCUSATE SODIUM 100 mg/1 N 20181231 55315-242_795acb64-f97a-4b95-a043-6d3e319e169b 55315-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part347 Freds Inc DIMETHICONE 125 mg/1 N 20181231 55315-244_ebd4c2ca-c92e-4fe6-9af5-4d859035cee8 55315-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20150430 OTC MONOGRAPH NOT FINAL part334 Freds Inc DOCUSATE SODIUM 100 mg/1 N 20181231 55315-245_75fb2aed-221d-4dba-9a87-9506abacdfea 55315-245 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20140331 OTC MONOGRAPH NOT FINAL part334 Freds Inc SENNOSIDES 25 mg/1 N 20181231 55315-248_49e1d1e2-3175-446f-9504-98798f032240 55315-248 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20090123 OTC MONOGRAPH FINAL part341 Fred's Inc CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg N 20181231 55315-250_4a3fc395-654b-4156-9541-4e0918cb4dfb 55315-250 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 20130301 OTC MONOGRAPH FINAL part340 Freds Inc CAFFEINE 200 mg/1 N 20181231 55315-251_9ebf69da-e28d-415e-8558-165c4864ad92 55315-251 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 20140328 OTC MONOGRAPH FINAL part340 Freds Inc CAFFEINE 200 mg/1 N 20181231 55315-253_481fddb0-cf6d-6073-e054-00144ff88e88 55315-253 HUMAN OTC DRUG Freds Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20101028 OTC MONOGRAPH FINAL part358G Fred's Inc. PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 55315-255_8aa13423-ed51-4be6-8d1c-5e5052a61b62 55315-255 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140328 ANDA ANDA091353 Freds Inc NAPROXEN SODIUM 220 mg/1 N 20181231 55315-256_54111468-e0cc-4ab1-8b21-47c3aa7ee607 55315-256 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140831 ANDA ANDA091353 Freds Inc NAPROXEN SODIUM 220 mg/1 N 20181231 55315-262_ef02ebd7-4477-4640-92aa-c88cbddc237a 55315-262 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080324 ANDA ANDA074916 Fred's Inc. IBUPROFEN 100 mg/5mL N 20181231 55315-268_600d2665-69ab-45cd-a54a-f40521a01dc1 55315-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20141231 OTC MONOGRAPH NOT FINAL part356 Freds Inc HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 55315-271_ae3686bc-00db-4ede-822e-03e9e8f11640 55315-271 HUMAN OTC DRUG Isopropyl alcohol 50 percent Isopropyl alcohol LIQUID TOPICAL 20141231 OTC MONOGRAPH NOT FINAL part333A Freds Inc ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 55315-272_12a48236-cf82-42f8-8bc8-14e64832316d 55315-272 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50 percent Wintergreen Isopropyl alcohol LIQUID TOPICAL 20141231 OTC MONOGRAPH NOT FINAL part333A Freds Inc ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 55315-275_fcef4d21-2acb-4a49-ab33-444e771584b0 55315-275 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20141231 OTC MONOGRAPH NOT FINAL part333A Freds Inc ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 55315-277_b016ec80-9b5d-4f57-80de-15aa582a7478 55315-277 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141231 OTC MONOGRAPH NOT FINAL part333A Freds Inc ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 55315-281_21144f63-fd1e-4e22-8a1a-38d2f98f7b0d 55315-281 HUMAN OTC DRUG Dry Scalp Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20090109 OTC MONOGRAPH FINAL part358H Fred's Inc PYRITHIONE ZINC 10 mg/mL N 20181231 55315-282_df55da34-186d-49ec-8b71-6a71105778cd 55315-282 HUMAN OTC DRUG Childrens Non Aspirin Acetaminophen SUSPENSION ORAL 20150630 OTC MONOGRAPH NOT FINAL part343 Freds Inc ACETAMINOPHEN 160 mg/5mL N 20181231 55315-288_80ab7e93-aba2-4f3e-ab7e-1dff67df5e71 55315-288 HUMAN OTC DRUG Childrens Pain Reliever Acetaminophen SUSPENSION ORAL 20151130 OTC MONOGRAPH NOT FINAL part343 Freds Inc ACETAMINOPHEN 160 mg/5mL N 20191231 55315-291_1aa3e6f8-767e-4bbc-9026-eabbf1208b87 55315-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 FRED'S, INC. IBUPROFEN 200 mg/1 N 20181231 55315-292_dbca40a4-01ab-4598-ae07-5a519e034ae0 55315-292 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 FRED'S, INC. IBUPROFEN 200 mg/1 N 20181231 55315-297_bf7f47a3-4d8a-4c08-97e5-caef70aa3fb6 55315-297 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide SUSPENSION ORAL 20151217 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL N 20191231 55315-298_bb76d185-d7c2-433a-a1a4-c510c3886cf5 55315-298 HUMAN OTC DRUG Senna Laxative Sennosides TABLET, FILM COATED ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 FRED'S, INC. SENNOSIDES 8.6 mg/1 N 20181231 55315-300_0be1ea7f-3a39-4750-96c6-cbf074a1a697 55315-300 HUMAN OTC DRUG Childrens Plus Flu Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, Phenylephrine HCI SUSPENSION ORAL 20150630 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 55315-304_fdf6b1b4-c318-4782-8e86-3551d29c2ffe 55315-304 HUMAN OTC DRUG Childrens Plus Multi Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride SUSPENSION ORAL 20150331 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 55315-309_abaceac9-fc26-4352-973f-5488d2a3d12c 55315-309 HUMAN OTC DRUG Cough Relief Adult Dextromethorphan HBr LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Freds Inc DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 55315-311_c6c1a11f-0b97-4c67-9f67-d06dd431ab4d 55315-311 HUMAN OTC DRUG Everyday Clean 2 in 1 Pyrithione zinc SHAMPOO TOPICAL 20090109 OTC MONOGRAPH FINAL part358H Fred's Inc PYRITHIONE ZINC 1 mg/mL N 20181231 55315-312_81774755-60c1-471b-aff7-e3fafc461781 55315-312 HUMAN OTC DRUG Childrens Dibromm Cold and Allergy Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Freds Inc BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/10mL; mg/10mL N 20181231 55315-313_f078b1f5-474d-4d9b-81ef-dd7e114cf72c 55315-313 HUMAN OTC DRUG Childrens Dibromm Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Freds Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 55315-316_3f0c456b-0921-4b7c-8542-13f0d1f9919d 55315-316 HUMAN OTC DRUG Daytime Flu Relief Therapy Severe Cough and Cold ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20151130 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55315-317_cc8f9266-8d63-48c8-8fd4-cd5e0ccbf92d 55315-317 HUMAN OTC DRUG Flu Relief Therapy Severe Cough and Cold Nighttime Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride LIQUID ORAL 20151130 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55315-324_3dcee38d-432e-46db-9719-6e2bc515e113 55315-324 HUMAN OTC DRUG Pain Relief Infants Acetaminophen SUSPENSION ORAL 20151231 OTC MONOGRAPH NOT FINAL part343 Freds Inc ACETAMINOPHEN 160 mg/5mL N 20181231 55315-325_5df4a292-7b18-5416-e053-2991aa0a06ce 55315-325 HUMAN OTC DRUG Freds Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Fred's, Inc. POVIDONE-IODINE 100 mg/mL N 20181231 55315-326_a7704f40-7f20-4adf-9b52-02feba32091b 55315-326 HUMAN OTC DRUG Womens Gentle Laxative Bisacodyl TABLET, COATED ORAL 20050212 20181214 OTC MONOGRAPH NOT FINAL part334 FRED'S, INC. BISACODYL 5 mg/1 E 20171231 55315-328_e184baaa-7547-48d3-b935-2e7e8e206f9b 55315-328 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 Freds Inc MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 55315-329_d3edfd1c-eb5d-490d-a6a3-2fcaa4b3a101 55315-329 HUMAN OTC DRUG Allergy Diphenhydramine HCl TABLET, COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 FRED'S, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 55315-333_4f70b3db-763c-4719-8111-c0aec85b2c9b 55315-333 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040430 ANDA ANDA076200 Fred's Inc. ACETAMINOPHEN 650 mg/1 N 20181231 55315-334_752ba3ac-d0bb-473c-ac0f-75ae6b06f94a 55315-334 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20161031 OTC MONOGRAPH NOT FINAL part334 Freds Inc MINERAL OIL 100 mg/100mL N 20181231 55315-337_cde51660-f3eb-4b3c-af3a-d292eaaffeb7 55315-337 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20151031 OTC MONOGRAPH FINAL part341 Freds Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 55315-341_ad2dc270-212c-4493-83dc-4ba82c77ca6a 55315-341 HUMAN OTC DRUG Hydrocortisone Plus 12 Moisturizers Maximum Strength Hydrocortisone CREAM TOPICAL 20090501 20180430 OTC MONOGRAPH NOT FINAL part348 Fred's Inc. HYDROCORTISONE 1 g/100g N 20181231 55315-342_1fe393a3-0375-47ea-9d2b-482530bf8634 55315-342 HUMAN OTC DRUG Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 55315-343_26d67fe7-5983-46f9-a8c3-14b305f8b840 55315-343 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part348 FREDS, INC HYDROCORTISONE 1 g/100g E 20171231 55315-344_c9beb088-b954-410d-bf14-be18d109ebd7 55315-344 HUMAN OTC DRUG Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20191231 55315-345_c2f39377-de6c-49eb-8e9c-57ae4764deb6 55315-345 HUMAN OTC DRUG Nighttime Cough Relief Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Freds Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 55315-351_628e9778-4502-45f3-87d8-9a45388ae666 55315-351 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20120330 ANDA ANDA200536 Fred's Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 55315-352_b1e38847-000e-4d7f-8b6f-d4252c2884f3 55315-352 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130901 ANDA ANDA201745 Fred's Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 55315-354_bb814628-cdd1-4fc0-87c5-5b2199494aea 55315-354 HUMAN OTC DRUG CHILDRENS ALLERGY RELIEF Cetirizine Hydrochloride SOLUTION ORAL 20150131 ANDA ANDA090750 Fred's, Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 55315-355_652dec40-5f57-4a1e-810f-6cb3f91d3446 55315-355 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20150115 ANDA ANDA202039 Fred's FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 55315-356_005a8ebb-d8e0-4f4d-a7f7-75b9b7dcd84d 55315-356 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride SOLUTION ORAL 20150131 OTC MONOGRAPH FINAL part338 Fred's, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 55315-357_17611218-40d9-477e-9163-42a7f6a0f044 55315-357 HUMAN OTC DRUG COLD and FLU Nighttime Relief Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr SOLUTION ORAL 20150824 OTC MONOGRAPH FINAL part341 Fred's, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 55315-358_17611218-40d9-477e-9163-42a7f6a0f044 55315-358 HUMAN OTC DRUG COLD and FLU Nighttime Relief Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr SOLUTION ORAL 20150824 OTC MONOGRAPH FINAL part341 Fred's, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 55315-359_b406f10d-c447-433c-87d8-991632de7706 55315-359 HUMAN OTC DRUG Daytime Relief Severe Cold and Flu acetaminophen, phenylephrine hcl, dextromethorphan hbr and guaifenesin SOLUTION ORAL 20150626 OTC MONOGRAPH FINAL part341 Fred's, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 55315-360_83ae4ea2-3e31-4984-8d8f-0d03e3c70e05 55315-360 HUMAN OTC DRUG NON ASPIRIN PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20121130 OTC MONOGRAPH FINAL part338 Freds Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 55315-365_0d0b2c82-9dc2-48e0-ba43-cc219a8505cc 55315-365 HUMAN OTC DRUG NightTime Relief Severe Cold and Flu acetaminophen, doxylamine succinate, phenylephrine hcl and dextromethorphan hbr SOLUTION ORAL 20150626 OTC MONOGRAPH FINAL part341 Fred's, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 55315-366_60c72b2c-db62-764a-e053-2a91aa0a0820 55315-366 HUMAN OTC DRUG Salicylic Acid Corn and Callus Remover Liquid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part358F Fred’s Stores of Tennessee, Inc SALICYLIC ACID .17 mg/9.8mL N 20181231 55315-367_d7a18421-f621-7431-6833-24f8acca00f3 55315-367 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20151016 ANDA ANDA078878 FREDS OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 55315-368_d7a18421-f621-7431-6833-24f8acca00f3 55315-368 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20151016 ANDA ANDA078878 FREDS OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 55315-369_392e5d0f-b90b-56df-e054-00144ff88e88 55315-369 HUMAN OTC DRUG LAXATIVE polyethylene glycol 3350 POWDER, FOR SOLUTION ORAL 20150901 ANDA ANDA090812 FRED'S INC. POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 55315-370_3b2bee8d-1d91-4e04-a4fd-a0fab085b493 55315-370 HUMAN OTC DRUG Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20150202 OTC MONOGRAPH NOT FINAL part333A Fred's, Inc ALCOHOL 70 mL/100mL N 20181231 55315-371_46cb3436-a9ca-4ff5-90d8-4486bd20e278 55315-371 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part335 Freds Inc BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 55315-372_4f33ebd6-6ab7-45b1-ac72-f53770c73aa9 55315-372 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part335 Freds Inc BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 55315-373_2afe96c1-0096-4857-bd96-11af8a614580 55315-373 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20171219 OTC MONOGRAPH FINAL part333C Fred’s Stores of Tennessee, Inc TOLNAFTATE 1.5 g/150g N 20181231 55315-374_6788b4c5-9327-4fff-ae29-77a2bd17ae45 55315-374 HUMAN OTC DRUG Lidocaine Burn Relief AEROSOL, SPRAY TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part348 Fred’s Stores of Tennessee, Inc LIDOCAINE .64 g/127g N 20181231 55315-375_e5c25a98-2dae-4394-a8a7-7a42319dbcf1 55315-375 HUMAN OTC DRUG Salicylic acid Wart Remover PLASTER TOPICAL 20171219 OTC MONOGRAPH FINAL part358B Fred’s Stores of Tennessee, Inc SALICYLIC ACID .4 g/181 N 20181231 55315-376_f70641c1-4780-474d-a28e-8c4a25b338ed 55315-376 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20171219 OTC MONOGRAPH FINAL part358F Fred’s Stores of Tennessee, Inc SALICYLIC ACID 40 mg/91 N 20181231 55315-377_f456edfd-2b9c-4cd4-94ef-4043e62a93eb 55315-377 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20171219 OTC MONOGRAPH FINAL part358F Fred’s Stores of Tennessee, Inc SALICYLIC ACID 40 mg/41 N 20181231 55315-382_aeedeb81-90b4-438f-a6d8-b51576ca5c7a 55315-382 HUMAN OTC DRUG Tussin Multi Symptom Cold CF Adult Dextromethorphan HBr, Guaifenesin, Phenylephrine LIQUID ORAL 20150531 OTC MONOGRAPH FINAL part341 Freds Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 55315-384_3fafeb56-9948-4690-8854-2e13a76256c3 55315-384 HUMAN OTC DRUG Adult Tussin Cough and Chest Congestion DM Sugar Free Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Freds Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 55315-385_d45db863-295e-412d-91c6-ec94e37a9384 55315-385 HUMAN OTC DRUG Adult Tussin Cough and Chest Congestion DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Freds Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 55315-389_5fedd935-7090-46a7-b924-3d5ff992f82e 55315-389 HUMAN OTC DRUG Tussin mucus plus Chest Congestion Guaifenesin LIQUID ORAL 20160119 OTC MONOGRAPH FINAL part341 Freds Inc GUAIFENESIN 200 mg/10mL N 20181231 55315-390_a3698642-a389-474f-a7a9-51636ccce885 55315-390 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20141231 OTC MONOGRAPH FINAL part347 Freds Inc WITCH HAZEL 842 mg/mL N 20181231 55315-393_81d13b0e-439b-4ce6-aaa8-856591606d79 55315-393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 FRED'S, INC. IBUPROFEN 200 mg/1 N 20181231 55315-397_62deb96f-a9ff-4b6f-aa15-9ea251517eb5 55315-397 HUMAN OTC DRUG Aspirin chewable low dose Aspirin TABLET, CHEWABLE ORAL 20010904 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ASPIRIN 81 mg/1 N 20181231 55315-403_511d8cee-0d83-4886-b0c4-36ab1bf4f2f3 55315-403 HUMAN OTC DRUG Hand wash Benzalkonium chloride SOAP TOPICAL 20150123 OTC MONOGRAPH NOT FINAL part333A Fred's Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55315-404_258afc2b-f77a-491a-8e77-dc82c43a25d0 55315-404 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20141130 OTC MONOGRAPH FINAL part338 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55315-411_cfc02af3-529c-4a36-8042-93821d854273 55315-411 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate and Dextromethorphan HBr TABLET, COATED ORAL 20030503 OTC MONOGRAPH FINAL part341 FRED'S, INC. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 55315-413_5df489e4-d619-66fa-e053-2991aa0a88cc 55315-413 HUMAN OTC DRUG Freds Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Fred's, Inc. ZINC OXIDE 160 mg/mL N 20181231 55315-428_0f7dc960-0b86-47ed-930e-2dbdfaa81be2 55315-428 HUMAN OTC DRUG Tension Headache Relief Acetaminophen, Caffeine TABLET, FILM COATED ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 55315-453_f7d6247d-3824-4641-8572-e7d356640662 55315-453 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 FRED'S, INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 55315-455_44311b23-59d0-42b2-9c71-aff538b04502 55315-455 HUMAN OTC DRUG Sinus Congestion and Pain Nighttime Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl TABLET, FILM COATED ORAL 20050628 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 55315-456_54ef0d66-b73a-4ac5-b178-48c1985baa45 55315-456 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20050628 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 55315-466_82314a0e-4e46-4328-ac24-edc686451a69 55315-466 HUMAN OTC DRUG Sinus Congestion and Pain Non-Drowsy Acetaminophen and Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55315-468_362bbb73-c929-4514-befb-e951722ef561 55315-468 HUMAN OTC DRUG Daytime cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20151218 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55315-470_a329d3fa-94e3-44af-899f-0efce90074c9 55315-470 HUMAN OTC DRUG Non Drowsy Day Time cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20120702 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55315-471_dab9e9e5-5119-4429-9bba-74f2c4eb3510 55315-471 HUMAN OTC DRUG Night Time Cold and Flu Relief Multi Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20151031 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 55315-480_62517b5a-3110-4840-9fe1-d2b94048ef4b 55315-480 HUMAN OTC DRUG Night time multi symptom cold/flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120702 OTC MONOGRAPH FINAL part341 Freds Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 55315-483_1edcfdfb-523a-4a14-8c18-d0956995b52e 55315-483 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 20151218 OTC MONOGRAPH FINAL part336 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55315-487_45696b73-1749-4aca-a73a-caecc388c6cd 55315-487 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part347 Freds Inc DIMETHICONE 125 mg/1 N 20181231 55315-492_fa4b9135-370e-4d0e-b9bb-18b14a81db75 55315-492 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 Freds Inc SENNOSIDES 25 mg/1 N 20191231 55315-502_bd2953b8-4a90-4f56-b30b-b42c66db5d99 55315-502 HUMAN OTC DRUG Sinus Pressure and Pain Acetaminophen, Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55315-503_f5b3121d-30cf-4b6e-a7b8-0969a86b0ec0 55315-503 HUMAN OTC DRUG Cold Head Congestion Non-Drowsy Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guaifenesin TABLET, FILM COATED ORAL 20050804 20190126 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 55315-504_f326558f-26ad-4297-a869-4ebf1bdde647 55315-504 HUMAN OTC DRUG Cold and Flu Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20191231 55315-505_c0a4ce23-79bd-4d5d-bd85-99f8c80631c4 55315-505 HUMAN OTC DRUG Mucus Relief DM Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20160430 OTC MONOGRAPH FINAL part341 Freds Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 55315-518_aec2eb49-29dc-4efa-be4a-29e1c83cba2e 55315-518 HUMAN OTC DRUG Allergy Acetaminophen and Diphenhydramine HCl TABLET ORAL 20050606 20180610 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 12.5 mg/1; mg/1 E 20171231 55315-519_2654de26-50b5-4389-ad11-08ae226cacb4 55315-519 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN 500 mg/1 N 20181231 55315-520_40298a3d-737e-40f3-a692-ee917bc5bb12 55315-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100708 NDA NDA021855 Freds Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 55315-525_5a35ca2a-812d-4f99-aca3-95293b831e3b 55315-525 HUMAN OTC DRUG Anti-Itch Maximum Strength diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20080808 OTC MONOGRAPH NOT FINAL part348 Fred's Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g E 20171231 55315-527_d537cfc4-e323-42b5-929d-c426d9e094bf 55315-527 HUMAN OTC DRUG Sinus Congestion and Pain Non Drowsy Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 55315-528_e6b4ba46-231b-4cf7-bbd4-f0c506d9930a 55315-528 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Fred's Inc. LORATADINE 10 mg/1 N 20181231 55315-529_cf0be8c3-50d2-4b7f-8120-33754890e2b2 55315-529 HUMAN OTC DRUG Loratadine OD Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Fred's Inc. LORATADINE 10 mg/1 N 20181231 55315-530_7e8139eb-0129-4596-b29b-49260161b53a 55315-530 HUMAN OTC DRUG Anti-Gas Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20130315 OTC MONOGRAPH FINAL part332 Freds Inc DIMETHICONE 180 mg/1 N 20181231 55315-531_a87eaa08-5bb4-4ee4-80a3-cafdc08b2a75 55315-531 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN 500 mg/1 N 20181231 55315-550_9130b348-455c-4f94-a77b-53a70ce56862 55315-550 HUMAN OTC DRUG Gas Relief SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20120829 OTC MONOGRAPH FINAL part332 Freds Inc DIMETHICONE 125 mg/1 N 20181231 55315-552_ef02ebd7-4477-4640-92aa-c88cbddc237a 55315-552 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Fred's Inc. IBUPROFEN 100 mg/5mL N 20181231 55315-557_45b1bbde-c8f1-4748-9b8d-67b61698c48e 55315-557 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55315-558_786ddb9d-4d17-4321-8c26-b474ce6ad42e 55315-558 HUMAN OTC DRUG Sinus Congestion and Pain Non-Drowsy Acetaminophen and Phenylephrine HCl TABLET ORAL 20080317 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55315-559_92a66f0d-77ea-4d72-ad3c-5c105ae9709d 55315-559 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate TABLET ORAL 20080317 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 55315-560_205b7ae7-6ec2-44f8-8533-0899d0a7735d 55315-560 HUMAN OTC DRUG Cold Multi-Symptom, Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20080329 OTC MONOGRAPH FINAL part341 FRED'S, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55315-600_00d68fa2-d645-4963-96b0-0ea4ab3aaa60 55315-600 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ASPIRIN 81 mg/1 N 20181231 55315-619_60b707c3-bfc1-5168-e053-2991aa0aca55 55315-619 HUMAN OTC DRUG ANTACID MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20120501 OTC MONOGRAPH FINAL part331 FREDS, INC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 55315-624_60b649fe-4210-1c50-e053-2a91aa0a0c93 55315-624 HUMAN OTC DRUG ANTACID SUPREME calcium carbonate, magnesium hydroxide SUSPENSION ORAL 20120501 OTC MONOGRAPH FINAL part331 FREDS, INC CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 400; 135 mg/5mL; mg/5mL N 20181231 55315-629_60b681d3-4f38-88d4-e053-2991aa0a264e 55315-629 HUMAN OTC DRUG ANTACID REGULAR STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20150601 OTC MONOGRAPH FINAL part331 FREDS, INC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 55315-630_07554fa8-ba4b-444f-b8b8-ea06eb77d369 55315-630 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 20100708 OTC MONOGRAPH FINAL part336 Freds Inc DIMENHYDRINATE 50 mg/1 N 20181231 55315-645_b0bba60c-4b46-4cd2-8c24-3acaa8d4b707 55315-645 HUMAN OTC DRUG ASPIRIN LOW DOSE Aspirin TABLET, COATED ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ASPIRIN 81 mg/1 N 20181231 55315-647_60155f6a-8d00-1cdb-e053-2991aa0a1d67 55315-647 HUMAN OTC DRUG MILK OF MAGNESIA magnesium hydroxide SUSPENSION ORAL 20120501 OTC MONOGRAPH NOT FINAL part334 FRED'S INC. MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 55315-648_6050da7f-160b-4380-e053-2a91aa0a3624 55315-648 HUMAN OTC DRUG MILK OF MAGNESIA CHERRY magnesium hydroxide LIQUID ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 FREDS, INC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 55315-649_6028833d-f947-4a44-e053-2a91aa0ae1a6 55315-649 HUMAN OTC DRUG MILK OF MAGNESIA magnesium hydroxide SUSPENSION ORAL 20120501 OTC MONOGRAPH NOT FINAL part334 FREDS, INC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 55315-676_2ba466f1-664e-429a-a8b6-329a1ea40e53 55315-676 HUMAN OTC DRUG Womens Gentle Laxative Bisacodyl TABLET, COATED ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 FRED'S, INC. BISACODYL 5 mg/1 N 20191231 55315-689_1d884e02-bb1e-41e1-9910-e2dd3372fa0d 55315-689 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr TABLET, COATED ORAL 20170331 OTC MONOGRAPH FINAL part341 FRED'S, INC. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 55315-690_0e78f413-e840-4de8-89e8-24392a978a66 55315-690 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl TABLET ORAL 20100722 OTC MONOGRAPH FINAL part336 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55315-720_903905b0-dd10-47b3-bd02-428ba3a66026 55315-720 HUMAN OTC DRUG ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20110726 OTC MONOGRAPH NOT FINAL part333E FRED'S INC TRICLOSAN .115 mL/100mL N 20181231 55315-721_71c993e5-17ba-4f90-a936-b95ecc367230 55315-721 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130408 OTC MONOGRAPH FINAL part341 Freds Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55315-730_56881914-2727-458e-a4f9-b4aa9de3850d 55315-730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20090609 ANDA ANDA074164 Fred's Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 55315-731_e2f67424-7f8d-4c81-8119-a7a8b33b72d0 55315-731 HUMAN OTC DRUG Miconazole 3 Combination Pack Miconazole Nitrate KIT 20090609 ANDA ANDA074926 Fred's Inc. N 20181231 55315-809_b3041323-f129-4e24-a1ed-ca02c139c077 55315-809 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A Fred's Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 55315-822_9840e338-72bf-4453-9fc4-fb2dac3bd6f9 55315-822 HUMAN OTC DRUG Double Antibiotic Plus Pain Relief Maximum Strength Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride CREAM TOPICAL 20090501 OTC MONOGRAPH NOT FINAL part347 Fred's Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g N 20181231 55315-823_4d99c028-c141-4919-b221-57b8a51f9a0d 55315-823 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride OINTMENT TOPICAL 20090501 OTC MONOGRAPH FINAL part333B Fred's Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 55315-824_e75cdefe-4c30-4848-889c-130a46965f1d 55315-824 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20151202 OTC MONOGRAPH FINAL part358F Fred’s Stores of Tennessee, Inc SALICYLIC ACID .17 g/9mL N 20181231 55315-825_62053a68-f89a-05b1-68c3-c3775e61900f 55315-825 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20161128 ANDA ANDA208150 Freds Inc FLUTICASONE PROPIONATE 50 ug/1 N 20181231 55315-934_be1e9eb1-c0c4-4404-881e-355530bdb8cb 55315-934 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 FRED'S, INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55315-940_6156ad1c-9fef-07fa-e053-2a91aa0a1a2c 55315-940 HUMAN OTC DRUG IBUPROFEN IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20170101 ANDA ANDA079205 FRED'S INC. IBUPROFEN 200 mg/1 N 20181231 55315-953_1948fef3-8ec2-4f2b-9dcc-0c2b30f0cd6c 55315-953 HUMAN OTC DRUG Suphedrine PE Congestion Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 FRED'S, INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 55315-986_6d45f98c-cc14-4763-8094-595ddb4963f7 55315-986 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 FRED'S, INC. DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 55315-987_5449354c-727d-632a-e054-00144ff8d46c 55315-987 HUMAN OTC DRUG Acetaminophen Acetaminophen CAPSULE ORAL 20170817 OTC MONOGRAPH NOT FINAL part343 FFREDS, INC ACETAMINOPHEN 500 mg/1 N 20181231 55315-988_5486d426-470a-0bed-e054-00144ff8d46c 55315-988 HUMAN OTC DRUG Acetaminophen Diphenhydramine HCl Acetaminophen Diphenhydramine HCl CAPSULE ORAL 20170817 OTC MONOGRAPH NOT FINAL part343 FREDS, INC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55315-989_54899dc4-b49b-2b10-e054-00144ff8d46c 55315-989 HUMAN OTC DRUG Acetaminophen Acetaminophen CAPSULE ORAL 20170817 OTC MONOGRAPH NOT FINAL part343 FREDS, INC ACETAMINOPHEN 500 mg/1 N 20181231 55315-990_5498dc41-9e2b-3dad-e054-00144ff8d46c 55315-990 HUMAN OTC DRUG Acetaminophen Diphenhydramine HCl Acetaminophen Diphenhydramine HCl CAPSULE ORAL 20170817 OTC MONOGRAPH NOT FINAL part343 FREDS, INC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55315-991_54ae55e0-1f35-072e-e054-00144ff88e88 55315-991 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20170817 ANDA ANDA091353 FREDS INC NAPROXEN SODIUM 220 mg/1 N 20181231 55315-992_54ae55e0-1f35-072e-e054-00144ff88e88 55315-992 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20170817 ANDA ANDA091353 FREDS INC NAPROXEN SODIUM 220 mg/1 N 20181231 55316-001_ab322ce9-a345-40fc-85ac-8872566b78f4 55316-001 HUMAN OTC DRUG Body Menthol, zinc oxide POWDER TOPICAL 20131214 OTC MONOGRAPH NOT FINAL part348 DZA Brands LLC MENTHOL 1.5 mg/g N 20181231 55316-003_b4adab31-2ba3-49c8-a9bb-c8b8b6122488 55316-003 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20060513 OTC MONOGRAPH FINAL part355 DZA Brands, LLC SODIUM FLUORIDE .1 mg/mL N 20181231 55316-004_290e34d6-9d82-4436-a102-57819a2784d1 55316-004 HUMAN OTC DRUG Anticavity Rinse Sodium Fluoride MOUTHWASH ORAL 20111130 OTC MONOGRAPH FINAL part355 DZA Brands SODIUM FLUORIDE .2 mg/mL N 20191231 55316-005_0f79bf72-5233-4c6a-ad16-cf8c80aa8793 55316-005 HUMAN OTC DRUG healthy accents childrens multi symptom fever and cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20151022 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 55316-007_92d241f2-2c52-4593-9bb3-9aa1d34d1962 55316-007 HUMAN OTC DRUG Healthy Accents Nasoflow Fluticasone propionate SPRAY, METERED NASAL 20160722 ANDA ANDA207957 DZA Brands LLC FLUTICASONE PROPIONATE 50 ug/1 N 20181231 55316-009_fa52f274-d453-4ddd-8fd2-4c89b6aac6b1 55316-009 HUMAN OTC DRUG Daily Oatmeal Dimethicone LOTION TOPICAL 20150406 OTC MONOGRAPH FINAL part347 DZA BRANDS, LLC DIMETHICONE 13 mg/mL N 20181231 55316-011_efb1c4c3-c0f4-4e84-abd4-b9a36569d871 55316-011 HUMAN OTC DRUG 2 in 1 Dandruff Pyrithione zinc SHAMPOO TOPICAL 20150320 OTC MONOGRAPH FINAL part358H DZA Brands PYRITHIONE ZINC 1 g/mL N 20181231 55316-012_324e3f1d-d80c-4ecf-a7c4-bb375b11d91c 55316-012 HUMAN OTC DRUG Nighttime Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170308 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55316-013_584a8560-deee-42f6-a730-2453ff608448 55316-013 HUMAN OTC DRUG cold, flu and sore throat acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170308 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55316-014_6bb89563-811e-4eba-9906-dddf545e0dea 55316-014 HUMAN OTC DRUG healthy accents antacid Calcium carbonate TABLET, CHEWABLE ORAL 20170323 OTC MONOGRAPH FINAL part331 DZA Brands LLC CALCIUM CARBONATE 750 mg/1 N 20181231 55316-016_cd4aefae-0b84-41ed-859d-ff83ba31b3e4 55316-016 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20131230 OTC MONOGRAPH NOT FINAL part343 Healthy Accents (DZA Brands, LLC) ACETAMINOPHEN 500 mg/1 N 20181231 55316-017_c5252f60-b4a1-4c28-9370-bbf3e1307100 55316-017 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20150320 OTC MONOGRAPH FINAL part358H DZA BRANDS, llc PYRITHIONE ZINC 10 mg/mL N 20181231 55316-018_494a7886-d68e-1648-e054-00144ff8d46c 55316-018 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20130318 OTC MONOGRAPH FINAL part341 DZA Brands, LLC MENTHOL 5.4 mg/1 N 20181231 55316-019_4a150584-79cd-1789-e054-00144ff8d46c 55316-019 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20130318 OTC MONOGRAPH FINAL part341 DZA Brands LLC MENTHOL 5.8 mg/1 N 20181231 55316-020_4a15aa91-a2f7-3295-e054-00144ff8d46c 55316-020 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20130318 OTC MONOGRAPH FINAL part341 DZA Brands LLC MENTHOL 7.5 mg/1 N 20181231 55316-021_4a16bd8f-0d3b-46b7-e054-00144ff8d46c 55316-021 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20160623 OTC MONOGRAPH FINAL part341 DZA Brands LLC MENTHOL 7.5 mg/1 N 20181231 55316-022_4a26944a-36e5-264f-e054-00144ff8d46c 55316-022 HUMAN OTC DRUG Natural Herbal Cough Drops Menthol LOZENGE ORAL 20160621 OTC MONOGRAPH FINAL part341 DZA Brands LLC MENTHOL 4.8 mg/1 N 20181231 55316-023_4a27061b-1861-3758-e054-00144ff8d46c 55316-023 HUMAN OTC DRUG Natural Herbal Cough Drop Menthol LOZENGE ORAL 20160621 OTC MONOGRAPH FINAL part341 DZA Brands LLC MENTHOL 4.8 mg/1 N 20181231 55316-024_4a172655-5bb3-36f0-e054-00144ff88e88 55316-024 HUMAN OTC DRUG SF Menthol Cough Drops Menthol LOZENGE ORAL 20120517 OTC MONOGRAPH FINAL part341 DZA Brands LLC MENTHOL 5.8 mg/1 N 20181231 55316-025_4a22a165-0c5c-4bc9-e054-00144ff88e88 55316-025 HUMAN OTC DRUG SF Cherry Cough Drop Menthol LOZENGE ORAL 20120517 OTC MONOGRAPH FINAL part341 DZA Brands LLC MENTHOL 5.8 mg/1 N 20181231 55316-026_4a24dce1-b429-39e7-e054-00144ff8d46c 55316-026 HUMAN OTC DRUG SF Honey Lemon Cough Drop Menthol LOZENGE ORAL 20120517 OTC MONOGRAPH FINAL part341 DZA Brands LLC MENTHOL 7.6 mg/1 N 20181231 55316-027_4a278cc9-f1f2-7489-e054-00144ff88e88 55316-027 HUMAN OTC DRUG Cherry Sore Throat Lozenges Benzocaine LOZENGE ORAL 20160127 OTC MONOGRAPH NOT FINAL part356 DZA Brands LLC BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 55316-029_de2e09a5-f6ee-4363-b1f4-d0ce8dfeec41 55316-029 HUMAN OTC DRUG healthy accents nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20110606 ANDA ANDA076775 DZA Brands LLC NICOTINE 2 mg/1 N 20181231 55316-031_177f5080-df6b-4bed-8ed5-3745bee124be 55316-031 HUMAN OTC DRUG Healthy Accents Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20160328 OTC MONOGRAPH FINAL part341 DZA Brands LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 55316-037_0b76052a-0500-40cb-b417-7801d84ab2a5 55316-037 HUMAN OTC DRUG Mucus Relief Congestion and Cough Maximum Strength dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride LIQUID ORAL 20160630 OTC MONOGRAPH FINAL part341 Healthy Accents (DZA Brands, LLC) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 55316-050_d57674a3-517a-4092-ac05-95a95da22116 55316-050 HUMAN OTC DRUG healthy accents ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090415 ANDA ANDA079113 DZA Brands LLC DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 55316-052_6f34f8cb-6ef2-4ad1-a4a5-39d938bceac0 55316-052 HUMAN OTC DRUG Healthy Accents Sleeptime Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20160511 OTC MONOGRAPH FINAL part338 DZA Brands LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55316-054_8e2f715e-ee3d-4f6d-9a65-a28a50cdf9c1 55316-054 HUMAN OTC DRUG Healthy Accents 12 Hour Nasal Decongestant maximum strength Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110719 ANDA ANDA075153 DZA Brands LLC PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 55316-055_3f0f16b7-2768-41a4-8bb4-069bffcf291a 55316-055 HUMAN OTC DRUG HOME 360 moist Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A DZA BRANDS LLC BENZALKONIUM CHLORIDE .115 g/1 N 20181231 55316-056_188c9fb5-e6b7-4eb1-b8bf-98fbfc886842 55316-056 HUMAN OTC DRUG healthy accents nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140213 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 55316-057_5015bfe3-edf0-4ac2-b0c8-33ca20dace69 55316-057 HUMAN OTC DRUG healthy accents ibuprofen infants ibuprofen SUSPENSION ORAL 20080218 ANDA ANDA075217 DZA Brands LLC IBUPROFEN 50 mg/1.25mL N 20181231 55316-063_7b58418f-7b00-4069-ae51-3a4b0ea008d5 55316-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20080205 OTC MONOGRAPH FINAL part346 DZB Brands, LLC FERRIC OXIDE RED; ZINC OXIDE .8; .8 kg/100L; kg/100L N 20181231 55316-065_8668e69b-0a67-4dcd-ae77-91046b7a9067 55316-065 HUMAN OTC DRUG healthy accents nasal Oxymetazoline HCl SPRAY NASAL 20080224 OTC MONOGRAPH FINAL part341 DZA Brands LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 55316-069_4b815195-d0d5-4405-b42c-0e9626842458 55316-069 HUMAN OTC DRUG Pure petroleum White Petrolatum JELLY TOPICAL 20090105 OTC MONOGRAPH FINAL part347 DZA Brands LLC PETROLATUM 1 g/g N 20181231 55316-072_9fd843df-4f1d-43a0-9ad3-582c6b699cba 55316-072 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol MOUTHWASH ORAL 20010629 OTC MONOGRAPH NOT FINAL part348 DZA Brands, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 55316-081_35faa191-84ef-44ba-8654-d1893f0cb65b 55316-081 HUMAN OTC DRUG healthy accents miconazole 3 Miconazole nitrate KIT 20080401 ANDA ANDA075329 DZA Brands LLC N 20181231 55316-084_d6ab3693-7534-4d3c-a1b9-909d71df0bde 55316-084 HUMAN OTC DRUG Healthy Accents Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20170207 OTC MONOGRAPH FINAL part335 DZA Brands LLC BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 55316-090_8dc9327a-4cd9-4943-8661-83042cb3208b 55316-090 HUMAN OTC DRUG healthy accents day time night time Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20080401 OTC MONOGRAPH FINAL part341 DZA Brands LLC N 20181231 55316-090_b1390e77-e713-43c6-b65d-2f09307c7f13 55316-090 HUMAN OTC DRUG healthy accents daytime nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110517 OTC MONOGRAPH FINAL part341 DZA Brands LLC N 20181231 55316-090_e4a1b317-0caa-483d-a0f5-bb605f2c41e2 55316-090 HUMAN OTC DRUG Healthy Accents Nighttime Daytime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20121108 OTC MONOGRAPH FINAL part341 DZA Brands LLC N 20181231 55316-094_f615dccd-22b3-4f4d-a7ab-5189159b7909 55316-094 HUMAN OTC DRUG healthy accents nasal decongestant maximum strength Phenylephrine Hydrochloride TABLET ORAL 20080401 OTC MONOGRAPH FINAL part341 DZA Brands LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 55316-096_df2617b4-6654-4ed5-b041-06b388243fbb 55316-096 HUMAN OTC DRUG healthy accents severe cold daytime Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20150930 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 55316-101_a063d361-172c-4e76-bedd-cba51419220c 55316-101 HUMAN OTC DRUG healthy accents complete lice treatment Piperonyl butoxide, pyrethrum extract KIT 20160504 OTC MONOGRAPH FINAL part358G DZA Brands LLC N 20181231 55316-102_d5a80157-7e08-45e4-914a-5773141f4f2d 55316-102 HUMAN OTC DRUG HEALTHY ACCENTS ANTIBACTERIAL WHITE TEA BENZALKONIUM CHLORIDE LIQUID TOPICAL 20150203 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55316-102_ddf56859-5fbf-40d3-9178-a7e79c7d30c3 55316-102 HUMAN OTC DRUG Healthy Accents Antibacterial White Tea Benzalkonium Chloride LIQUID TOPICAL 20170427 OTC MONOGRAPH NOT FINAL part333E DZA Brands LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55316-104_5abba093-8b9f-48f7-b04a-609c4e615574 55316-104 HUMAN OTC DRUG Healthy Accents Pain Relief Acetaminophen CAPSULE, COATED ORAL 20160524 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN 500 mg/1 N 20181231 55316-105_5fef7c3a-1f99-47ee-9247-b3aa845c782d 55316-105 HUMAN OTC DRUG healthy accents pain relief childrens Acetaminophen SUSPENSION ORAL 20080517 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN 160 mg/5mL N 20181231 55316-109_1a440264-495a-4ca2-a5f2-2d7465094e03 55316-109 HUMAN OTC DRUG Health Accents Antibacterial Foaming Hand Fresh Pear Benzalkonium Chloride SOAP TOPICAL 20170606 OTC MONOGRAPH NOT FINAL part333E DZA Brands LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55316-117_6357848d-4cd8-4126-907c-253f7fe7f908 55316-117 HUMAN OTC DRUG healthy accents lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 DZA Brands LLC LANSOPRAZOLE 15 mg/1 N 20181231 55316-120_b89b4133-6e85-47ac-af13-fd32aa2d7490 55316-120 HUMAN OTC DRUG Miconazole Nitrate Jock Itch Spray AEROSOL, SPRAY TOPICAL 20171221 OTC MONOGRAPH FINAL part333C DZA BRANDS LLC MICONAZOLE NITRATE 1.3 g/131g N 20181231 55316-121_f4a58b72-9047-408d-a92b-1b7a31fd0197 55316-121 HUMAN OTC DRUG Miconazole Nitrate Athlete s Foot Spray AEROSOL, POWDER TOPICAL 20171221 OTC MONOGRAPH FINAL part333C DZA BRANDS LLC MICONAZOLE NITRATE 2.6 g/130g N 20181231 55316-122_985ffb32-c985-408f-aa24-50c738f1cd46 55316-122 HUMAN OTC DRUG Salicylic Acid One Step Wart Remover Clear Strips PLASTER TOPICAL 20171221 OTC MONOGRAPH FINAL part358B DZA BRANDS LLC SALICYLIC ACID 40 mg/141 N 20181231 55316-123_e1da50e3-69a5-4c4d-ae05-95c55b0d2f5f 55316-123 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20171221 OTC MONOGRAPH FINAL part358F DZA BRANDS LLC SALICYLIC ACID 40 mg/91 N 20181231 55316-130_7354cdc8-75f4-45c0-810c-20911c2a253a 55316-130 HUMAN OTC DRUG healthy accents pain relief Acetaminophen SUSPENSION ORAL 20110606 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN 160 mg/5mL N 20181231 55316-131_961c9489-0086-404c-ad82-b3018fc74d15 55316-131 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20121211 ANDA ANDA078682 Healthy Accents (DZA Brands, LLC) IBUPROFEN 200 mg/1 N 20181231 55316-140_5f47fcd4-1b92-4ee6-9073-8502455a1008 55316-140 HUMAN OTC DRUG Healthy Accents Naproxen Sodium Naproxen sodium TABLET, FILM COATED ORAL 20130522 ANDA ANDA074661 DZA Brands LLC NAPROXEN SODIUM 220 mg/1 N 20181231 55316-141_77faeb77-33bc-4a46-87f6-8e146f43a167 55316-141 HUMAN OTC DRUG Healthy Accents Famotidine Famotidine TABLET ORAL 20091210 ANDA ANDA075400 DZA Brands LLC FAMOTIDINE 10 mg/1 N 20181231 55316-144_2f10a19c-4e4a-45b5-922c-f3f41130cc8d 55316-144 HUMAN OTC DRUG healthy accents mucus relief D Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20160825 ANDA ANDA091071 DZA Brands LLC GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 55316-145_3af7748f-cd40-46ec-bcf9-e209d5c7037e 55316-145 HUMAN OTC DRUG Healthy Accents Mucus Relief cold and sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130624 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 55316-153_a84c30fc-bdc4-4602-b16c-ae54f65df663 55316-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H DZA Brands, LLC PYRITHIONE ZINC 10 mg/mL N 20181231 55316-161_41ecd81c-ebde-42dc-8d73-61f8c7e608ef 55316-161 HUMAN OTC DRUG Healthy Accents infants pain and fever Acetaminophen SUSPENSION ORAL 20111206 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN 160 mg/5mL N 20181231 55316-163_92fea645-e334-41de-b262-f7f5a5e8cb9e 55316-163 HUMAN OTC DRUG ANTIBACTERIAL FOAMING FRESH PEAR TRICLOSAN LIQUID TOPICAL 20110322 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS LLC TRICLOSAN .46 mL/100mL N 20181231 55316-163_9de79b75-5b27-4c4b-b93c-b069aa9e1517 55316-163 HUMAN OTC DRUG ANTIBACTERIAL FOAMING FRESH PEAR TRICLOSAN LIQUID TOPICAL 20110322 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS LLC TRICLOSAN .46 mL/100mL N 20181231 55316-166_30e49d77-1bda-4ab5-b7f5-87d819426a64 55316-166 HUMAN OTC DRUG Healthy Accents ibuprofen childrens Ibuprofen SUSPENSION ORAL 20080303 ANDA ANDA074937 DZA Brands LLC IBUPROFEN 100 mg/5mL N 20181231 55316-169_560c6a4d-9b4c-4f58-a3cd-f388c23d79f1 55316-169 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20131230 ANDA ANDA079096 Healthy Accents (DZA Brands, LLC) NAPROXEN SODIUM 220 mg/1 N 20181231 55316-173_c3176207-0da3-43c6-87a3-3560d81649c0 55316-173 HUMAN OTC DRUG healthy accents complete lice treatment Piperonyl Butoxide, Pyrethrum Extract KIT 20091226 OTC MONOGRAPH FINAL part358G DZA Brands LLC N 20181231 55316-174_00e75f3a-e18a-4e7e-91ed-4bf88da532fd 55316-174 HUMAN OTC DRUG WOMANS LAXATIVE Bisacodyl TABLET, COATED ORAL 20100913 OTC MONOGRAPH NOT FINAL part334 Healthy Accents (DZA Brands, LLC) BISACODYL 5 mg/1 N 20181231 55316-175_5804b552-7ada-4822-b765-390d8ccacbae 55316-175 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20140930 NDA NDA021920 Healthy Accents (DZA Brands, LLC) NAPROXEN SODIUM 220 mg/1 N 20181231 55316-176_af656941-078a-4ed4-810f-954c705187ce 55316-176 HUMAN OTC DRUG Healthy Accents Cetirizine-D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20110713 ANDA ANDA077170 DZA Brands LLC CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 55316-177_3087195f-1807-47d6-810e-561eaeaff0ea 55316-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING REFILL TRICLOSAN LIQUID TOPICAL 20110322 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS LLC TRICLOSAN .46 mL/100mL N 20181231 55316-177_68b80135-5916-4370-b643-ec1238b5b299 55316-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING REFILL TRICLOSAN LIQUID TOPICAL 20110322 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS LLC TRICLOSAN .46 mL/100mL N 20181231 55316-179_c491bf05-fe0d-4f70-ab00-1eb155eb674a 55316-179 HUMAN OTC DRUG healthy accents antacid extra strength Calcium carbonate TABLET, CHEWABLE ORAL 20080122 OTC MONOGRAPH FINAL part331 DZA Brands LLC CALCIUM CARBONATE 750 mg/1 N 20181231 55316-181_3b37d2d3-48bb-46e3-a03f-550f59190621 55316-181 HUMAN OTC DRUG Healthy Accents Triple Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20140627 OTC MONOGRAPH FINAL part333B DZA Brands LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 55316-186_f546f761-ce87-44aa-babf-9ceb75a53f64 55316-186 HUMAN OTC DRUG healthy accents sleeptime Diphenhydramine HCl SOLUTION ORAL 20140509 OTC MONOGRAPH FINAL part338 DZA Brands LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 55316-188_b13fb04f-182a-4420-89ae-bf6997ddb66b 55316-188 HUMAN OTC DRUG Healthy Accents Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131030 OTC MONOGRAPH FINAL part346 DZA Brands LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 55316-190_becfd268-1f13-446f-b9e0-f7f48787efb4 55316-190 HUMAN OTC DRUG Laxative Bisacodyl TABLET, COATED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 Healthy Accents (DZA Brands, LLC) BISACODYL 5 mg/1 N 20181231 55316-194_14674cc3-eabc-483c-ac9d-0556b996df0d 55316-194 HUMAN OTC DRUG Healthy Accents Famotidine maximum strength Famotidine TABLET ORAL 20080413 ANDA ANDA077351 DZA Brands LLC FAMOTIDINE 20 mg/1 N 20181231 55316-196_8d6b011a-8aab-4632-a47f-14def29aa54f 55316-196 HUMAN OTC DRUG Healthy Accents Antibacterial Foaming Hand Benzalkonium Chloride SOAP TOPICAL 20170606 OTC MONOGRAPH NOT FINAL part333E DZA Brands LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55316-198_ec5b32ef-f68d-48f8-9838-cc26d6ce4de0 55316-198 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130415 ANDA ANDA078682 Healthy Accents (DZA Brands, LLC) IBUPROFEN 200 mg/1 N 20181231 55316-200_d2241892-8db3-424c-a7a0-adb38a9db237 55316-200 HUMAN OTC DRUG Healthy Accents Antacid calcium carbonate TABLET, CHEWABLE ORAL 20170413 OTC MONOGRAPH FINAL part331 DZA Brands LLC CALCIUM CARBONATE 750 mg/1 N 20181231 55316-205_71155d60-187b-4722-8332-d38f0ec5279e 55316-205 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20080508 OTC MONOGRAPH FINAL part358H DZA Brands, LLC COAL TAR 5 mg/mL N 20181231 55316-213_29f9fc98-f7df-4f41-9c22-12b926e4cfe8 55316-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20110107 OTC MONOGRAPH FINAL part355 DZA Brands, LLC SODIUM FLUORIDE .05 kg/100L N 20181231 55316-223_f48d1aa4-0ae4-4ce7-bf2e-0263e5d07570 55316-223 HUMAN OTC DRUG HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS LLC ALCOHOL 62 mL/100mL N 20181231 55316-224_3749411c-423e-4e3b-b017-f8656399f4d3 55316-224 HUMAN OTC DRUG healthy accents anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20080204 ANDA ANDA075232 DZA Brands LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 55316-225_e253eed3-880d-4f9f-98be-3b8304a0c0fc 55316-225 HUMAN OTC DRUG HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20111013 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS ALCOHOL 62 mL/100mL N 20181231 55316-227_b7eae08f-e124-4424-a9be-c851d8976e3f 55316-227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130301 OTC MONOGRAPH FINAL part343 Healthy Accents (DZA Brands, LLC) ASPIRIN 81 mg/1 N 20181231 55316-235_7850a049-e80b-403a-9cc7-7c1f44280cd6 55316-235 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20150504 ANDA ANDA076460 Healthy Accents (DZA Brands, LLC) IBUPROFEN 200 mg/1 N 20181231 55316-243_b3ba7739-2ab7-492b-a689-135b9f06e740 55316-243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20090105 OTC MONOGRAPH FINAL part333A DZA Brands LLC TRICLOSAN .15 kg/100L N 20181231 55316-249_c9b6af6f-7e96-499e-befd-2f7deff7f2cb 55316-249 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20131230 ANDA ANDA079174 Healthy Accents (DZA Brands, LLC) IBUPROFEN 200 mg/1 N 20181231 55316-253_8efc98b7-2016-4a0f-ac8e-3c46194fe61e 55316-253 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20170427 OTC MONOGRAPH NOT FINAL part333E DZA Brands LLC ALCOHOL 650 mg/mL N 20181231 55316-253_d394b7d9-cc74-4862-a732-a82f17ec256c 55316-253 HUMAN OTC DRUG HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20130528 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS LLC ALCOHOL 650 mg/mL N 20181231 55316-255_68f9d8a7-7808-4743-ada2-5e14672a2fd3 55316-255 HUMAN OTC DRUG healthy accents ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20110606 ANDA ANDA075217 DZA Brands LLC IBUPROFEN 50 mg/1.25mL N 20181231 55316-267_7c2a44be-8b78-4d91-9ef0-cc4268d7435f 55316-267 HUMAN OTC DRUG HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20111012 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS ALCOHOL 65 mL/100mL N 20181231 55316-267_820e4223-0313-4f28-adce-50ba3f869a53 55316-267 HUMAN OTC DRUG HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20111012 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS ALCOHOL 65 mL/100mL N 20181231 55316-268_ae962ccf-4667-4058-ab89-d393f66a1fa6 55316-268 HUMAN OTC DRUG HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110314 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS LLC ALCOHOL 62 mL/100mL N 20181231 55316-272_9caf8852-3f9c-4ed5-b8cc-245bca691751 55316-272 HUMAN OTC DRUG healthy accents sinus congestion and pain day time Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20080310 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55316-274_1132727e-2a0e-4e0c-ad47-5307de614fb5 55316-274 HUMAN OTC DRUG healthy accents aspirin Aspirin TABLET, CHEWABLE ORAL 20110606 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ASPIRIN 81 mg/1 N 20181231 55316-279_20914647-4ef8-42f6-9240-e44d318f947a 55316-279 HUMAN OTC DRUG healthy accents hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141030 OTC MONOGRAPH FINAL part346 DZA Brands LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 55316-281_cdbab220-0ccb-4326-af79-afa172b7e443 55316-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20080220 OTC MONOGRAPH FINAL part358H DZA Brands, LLC PYRITHIONE ZINC 100 g/mL N 20181231 55316-288_8d212fa5-a9df-4d14-9935-29b7b33f4d18 55316-288 HUMAN OTC DRUG Healthy Accents Childrens Mucus Relief Guaifenesin SOLUTION ORAL 20130710 OTC MONOGRAPH FINAL part341 DZA Brands LLC GUAIFENESIN 100 mg/5mL N 20181231 55316-294_740065db-6f50-42ec-9d97-795d0555a71c 55316-294 HUMAN OTC DRUG Childrens Mucus Relief Dextromethorphan HBr, Guaifensin LIQUID ORAL 20160229 OTC MONOGRAPH FINAL part341 Healthy Accents (DZA Brands, LLC) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 55316-296_4d4dba0f-6a87-488a-9428-6086d62b29a2 55316-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20090602 OTC MONOGRAPH FINAL part358H DZA Brands, LLC PYRITHIONE ZINC 10 mg/mL N 20181231 55316-299_faf46347-5d53-44b5-8191-32860e6bc0ef 55316-299 HUMAN OTC DRUG Healthy Accents Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130522 ANDA ANDA072096 DZA Brands LLC IBUPROFEN 200 mg/1 N 20181231 55316-300_267991a1-4948-4a4a-bd49-5f2015bf43c1 55316-300 HUMAN OTC DRUG Healthy Accents Tussin Cough Adult Dextromethorphan Hydrobromide LIQUID ORAL 20080122 OTC MONOGRAPH FINAL part341 DZA Brands LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL N 20181231 55316-302_4f6e1576-b724-4869-afb2-7c09d718b5dd 55316-302 HUMAN OTC DRUG healthy accents stomach relief original strength Bismuth subsalicylate SUSPENSION ORAL 20080122 OTC MONOGRAPH FINAL part335 DZA Brands LLC BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 55316-304_8f50a849-d57e-48c6-8377-96efb145902a 55316-304 HUMAN OTC DRUG healthy accents nasal original oxymetazoline hydrochloride SPRAY NASAL 20080401 OTC MONOGRAPH FINAL part341 DZA Brands LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 55316-306_82ec61e1-baeb-4d9f-ade8-8c6edfe498da 55316-306 HUMAN OTC DRUG healthy accents clear lax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091106 ANDA ANDA090685 DZA Brands LLC POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 55316-309_d232bb39-c183-4da8-9f4a-6cb6e45482de 55316-309 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20080220 OTC MONOGRAPH FINAL part358H DZA Brands LLC PYRITHIONE ZINC 1 kg/100L N 20181231 55316-311_c7fff1de-5a1f-46a8-8f10-73dfdf064dcf 55316-311 HUMAN OTC DRUG Dandruff PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20050602 OTC MONOGRAPH FINAL part358H DZA Brands LLC PYRITHIONE ZINC 1 g/100mL N 20181231 55316-315_76b37d06-79d5-47b6-bd43-2e894d12dd28 55316-315 HUMAN OTC DRUG Healthy Accents Moisture Healing DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 DZA Brands LLC DIMETHICONE 1 mL/100mL N 20181231 55316-316_79f38840-1c39-4e23-96b5-36dce8439011 55316-316 HUMAN OTC DRUG Severe Cold and Cough Relief Daytime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20151031 OTC MONOGRAPH FINAL part341 Healthy Accents (DZA Brands, LLC) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55316-317_5a7655c4-dd2c-4a7a-a7e0-4c216bfdae06 55316-317 HUMAN OTC DRUG Nighttime Flu Relief Therapy Severe Cold Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Healthy Accents (DZA Brands, LLC) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55316-318_7552e698-f176-47d7-8469-daab82e93f2a 55316-318 HUMAN OTC DRUG Antiseptic EUCALYPTOL, Menthol, Methyl salicylate, thymol RINSE ORAL 20080205 OTC MONOGRAPH NOT FINAL part356 DZA Brands, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55316-321_9894aa74-f017-4aa6-9918-912098a164d7 55316-321 HUMAN OTC DRUG healthy accents famotidine calcium carbonate magnesium hydroxide famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20150328 ANDA ANDA077355 DZA Brands LLC FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 55316-325_9cbfe51c-f6fa-4bb2-afe5-59f2daa5c35f 55316-325 HUMAN OTC DRUG Healthy Accents Mucus Relief Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160811 ANDA ANDA091009 DZA Brands LLC GUAIFENESIN 1200 mg/1 N 20181231 55316-335_d5ed994c-b10d-43c5-9630-a94e63814d8a 55316-335 HUMAN OTC DRUG healthy accents nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110922 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 55316-336_7bcab2a7-0592-4151-93fc-ea1a25dc0fc3 55316-336 HUMAN OTC DRUG Mucus Relief Cold, Flu, and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20160630 OTC MONOGRAPH FINAL part341 Healthy Accents (DZA Brands, LLC) DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 650; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 55316-337_98c9fce9-3861-4a06-ad3b-b809ce087a73 55316-337 HUMAN OTC DRUG healthy accents stomach relief Bismuth subsalicylate SUSPENSION ORAL 20080122 OTC MONOGRAPH FINAL part335 DZA Brands LLC BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 55316-340_eb314025-269a-428a-b6fa-a1886aa296fd 55316-340 HUMAN OTC DRUG healthy accents antacid aluminum hydroxide, magnesium hydroxide, simethicone SUSPENSION ORAL 20080122 OTC MONOGRAPH FINAL part331 DZA Brands LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 55316-344_5edc21d9-9109-47e1-957e-8f727d3f7f59 55316-344 HUMAN OTC DRUG Healthy Accents Nicotine Nicotine Polacrilex LOZENGE ORAL 20110606 ANDA ANDA077007 DZA Brands LLC NICOTINE 2 mg/1 N 20181231 55316-359_be06e6ba-93fa-45b8-b6e4-c2d9b8ffeab3 55316-359 HUMAN OTC DRUG healthy accents tussin dm Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 20080122 OTC MONOGRAPH FINAL part341 DZA Brands LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 55316-368_7736874e-1abd-4b1c-b032-f14400b697c1 55316-368 HUMAN OTC DRUG Healthy Accents All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 20080122 ANDA ANDA074661 DZA Brands LLC NAPROXEN SODIUM 220 mg/1 N 20181231 55316-370_6abb1909-2dde-4747-ae37-f4f2206f4af1 55316-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part333A DZA Brands ALCOHOL 70 mL/100mL N 20181231 55316-371_0ee5e7a9-aaa5-4ee6-80c2-388e60866cc2 55316-371 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part335 Healthy Accents (DZA Brands, LLC) BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 55316-372_d0e6890b-d614-4561-9611-40869daaa386 55316-372 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part335 Healthy Accents (DZA Brands, LLC) BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 55316-374_74a8b078-f91b-4ecb-8788-8c5d209323f5 55316-374 HUMAN OTC DRUG Healthy Accents migraine formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20080310 ANDA ANDA075794 DZA Brands LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55316-379_2b1700fa-b32a-4216-b4c0-4a1afd74e3df 55316-379 HUMAN OTC DRUG healthy accents allergy Diphenhydramine Hydrochloride SOLUTION ORAL 20080401 OTC MONOGRAPH FINAL part341 DZA Brands LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 55316-381_237deb9a-bda3-4a0e-b49d-1b948b960ac5 55316-381 HUMAN OTC DRUG Healthy Accents Mucus Relief cold flu and sore throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130624 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55316-384_16ee2e5c-f6fb-496c-995a-c32f8ce869f3 55316-384 HUMAN OTC DRUG healthy accents cough relief dextromethorphan polistirex SUSPENSION ORAL 20121204 ANDA ANDA091135 DZA Brands LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 55316-396_b36c88e6-2e9c-4f29-a432-a8489a275364 55316-396 HUMAN OTC DRUG Healthy Accents milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20080122 OTC MONOGRAPH NOT FINAL part334 DZA Brands LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 55316-403_0fdafcee-c0c7-4c3b-9998-cd4f9cdd2deb 55316-403 HUMAN OTC DRUG Hand wash Benzalkonium chloride SOAP TOPICAL 20150206 OTC MONOGRAPH NOT FINAL part333A DZA Brands, LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55316-407_9caab708-fe7e-4273-a3d6-65dbddb2e9fd 55316-407 HUMAN OTC DRUG Healthy Accents Cold Sore Treatment Camphor CREAM TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part348 DZA Brands LLC BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 55316-409_f404c57f-b60c-407f-9e4f-856a6336cb39 55316-409 HUMAN OTC DRUG Healthy Accents Stay Awake Caffeine TABLET ORAL 20080204 OTC MONOGRAPH FINAL part340 DZA Brands LLC CAFFEINE 200 mg/1 N 20181231 55316-411_8efa586e-d091-45ae-b013-04da6cb52222 55316-411 HUMAN OTC DRUG Healthy Accents Pain Relief acetaminophen CAPSULE, LIQUID FILLED ORAL 20160511 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN 325 mg/1 N 20181231 55316-416_c79e167f-bb45-41ae-bc17-7d4c8f70a423 55316-416 HUMAN OTC DRUG Healthy Accents Aspirin Aspirin TABLET ORAL 20080122 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ASPIRIN 325 mg/1 N 20181231 55316-422_0c5fc4d1-f39d-409a-8abc-c46d4f3b7af8 55316-422 HUMAN OTC DRUG Healthy Accents Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20110507 ANDA ANDA078326 DZA Brands LLC NICOTINE 4 mg/1 N 20181231 55316-426_487cdfe6-3203-426f-b29a-db2ea80706e5 55316-426 HUMAN OTC DRUG healthy accents tioconazole 1 Tioconazole OINTMENT VAGINAL 20080406 ANDA ANDA075915 DZA Brands LLC TIOCONAZOLE 6.5 g/100g N 20181231 55316-428_e19f07f8-6bae-41ea-b2a0-88079b46ad1f 55316-428 HUMAN OTC DRUG Healthy Accents Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20080129 OTC MONOGRAPH FINAL part332 DZA Brands LLC DIMETHICONE 125 mg/1 N 20181231 55316-431_d83e6d7c-fa67-44ae-abba-53cc0237ba72 55316-431 HUMAN OTC DRUG healthy accents nighttime sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20080224 OTC MONOGRAPH FINAL part338 DZA Brands LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55316-432_f08b24da-20fa-43ef-815f-be63924bd7ae 55316-432 HUMAN OTC DRUG Healthy Accents Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20110623 OTC MONOGRAPH FINAL part341 DZA Brands LLC PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 55316-434_10a78348-31fe-4332-951e-590ad9f1da83 55316-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130910 OTC MONOGRAPH NOT FINAL part356 DZA Brands, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55316-435_41d1af07-7a93-497b-845d-0153f00f16a1 55316-435 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20150811 OTC MONOGRAPH FINAL part355 DZA Brands SODIUM FLUORIDE .2 mg/mL N 20181231 55316-437_dd95278b-52a3-4b1d-9be4-6ea9bf694282 55316-437 HUMAN OTC DRUG Healthy Accents Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20080129 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55316-439_83e31427-8a15-43b0-905b-1d32387bef7f 55316-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part333A DZA Brands ALCOHOL 700 mg/mL N 20181231 55316-441_3b7cc94f-6635-4c05-a0fd-82a242752942 55316-441 HUMAN OTC DRUG healthy accents sleep aid Doxylamine succinate TABLET ORAL 20110606 ANDA ANDA040167 DZA Brands LLC DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 55316-443_52e43723-a010-4bee-b899-1d012f9b3e0a 55316-443 HUMAN OTC DRUG Healthy Accents Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20170216 ANDA ANDA078104 DZA Brands LLC TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 55316-444_2a92d19e-6e60-4fff-859e-f610d9d21ebb 55316-444 HUMAN OTC DRUG healthy accents tussin Guaifenesin SYRUP ORAL 20140709 OTC MONOGRAPH FINAL part341 DZA Brands LLC GUAIFENESIN 200 mg/10mL N 20181231 55316-457_100b205d-faf9-4db2-89c6-23e704f23b9e 55316-457 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20150228 OTC MONOGRAPH NOT FINAL part343 Healthy Accents (DZA Brands, LLC) ACETAMINOPHEN 500 mg/1 N 20181231 55316-458_9f121354-4c07-425a-8523-5f5e292ee49f 55316-458 HUMAN OTC DRUG healthy accents cetirizine hydrochloride Cetirizine Hydrochloride TABLET ORAL 20080115 ANDA ANDA078336 DZA Brands LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55316-459_0eb60811-44b4-45de-ae2a-f23b995018bf 55316-459 HUMAN OTC DRUG healthy accents nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110817 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 55316-461_52b04a12-fccd-41e4-83dc-e6ee460146e0 55316-461 HUMAN OTC DRUG Healthy Accents Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20110630 ANDA ANDA076359 DZA Brands LLC IBUPROFEN 100 mg/1 N 20181231 55316-462_88d1cd1a-4ffe-4df7-aa2b-13803f2394e8 55316-462 HUMAN OTC DRUG healthy accents allergy relief diphenhydramine hydrochloride CAPSULE ORAL 20080129 OTC MONOGRAPH FINAL part341 DZA Brands LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55316-467_e6ac3377-5914-404a-9191-7319cc66a990 55316-467 HUMAN OTC DRUG healthy accents aspirin Aspirin TABLET, CHEWABLE ORAL 20080204 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ASPIRIN 81 mg/1 N 20181231 55316-475_b4a72e10-c598-4098-aa11-2dad1aee83a0 55316-475 HUMAN OTC DRUG Healthy Accents Childrens Allergy Cetirizine HCl SOLUTION ORAL 20151209 ANDA ANDA204226 DZA Brands LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 55316-478_31339740-8e39-44e9-99e5-42d97a11fe02 55316-478 HUMAN OTC DRUG healthy accents antacid calcium carbonate TABLET, CHEWABLE ORAL 20080211 OTC MONOGRAPH FINAL part331 DZA Brands LLC CALCIUM CARBONATE 500 mg/1 N 20181231 55316-479_3f1b8aae-bc9b-4287-b2bd-da146192eaf7 55316-479 HUMAN OTC DRUG healthy accents allergy relief Diphenhydramine Hydrochloride TABLET ORAL 20080129 OTC MONOGRAPH FINAL part341 DZA Brands LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55316-484_95c9ddc2-5dcd-44ec-853e-9238fce56b0c 55316-484 HUMAN OTC DRUG Healthy Accents Pain Relief extra strength Acetaminophen TABLET ORAL 20080204 OTC MONOGRAPH NOT FINAL part343 DZA Brands LLC ACETAMINOPHEN 500 mg/1 N 20181231 55316-485_c4453cba-0f2b-4896-a21a-e9a84714e6d8 55316-485 HUMAN OTC DRUG healthy accents antacid calcium carbonate TABLET, CHEWABLE ORAL 20120621 OTC MONOGRAPH FINAL part331 DZA Brands LLC CALCIUM CARBONATE 500 mg/1 N 20181231 55316-486_c94921cc-60d0-4a25-b9eb-7f306b4461db 55316-486 HUMAN OTC DRUG healthy accents stool softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20080406 OTC MONOGRAPH NOT FINAL part334 DZA Brands LLC DOCUSATE SODIUM 100 mg/1 N 20181231 55316-489_8c9f4168-fdd4-46f0-a53f-0c1cd1569e2f 55316-489 HUMAN OTC DRUG healthy accents antacid Calcium carbonate TABLET, CHEWABLE ORAL 20080122 OTC MONOGRAPH FINAL part331 DZA Brands LLC CALCIUM CARBONATE 750 mg/1 N 20181231 55316-500_ec3020d1-c2bc-4d15-8841-4aad4e097bd7 55316-500 HUMAN OTC DRUG Healthy Accents Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140207 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55316-516_8116f1eb-0c7a-42c3-ac7c-111b53a2e40f 55316-516 HUMAN OTC DRUG healthy accents tussin cf Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20080204 OTC MONOGRAPH FINAL part341 DZA Brands LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 55316-517_935f8043-d64e-4eac-b2bb-57675e29b60a 55316-517 HUMAN OTC DRUG Healthy Accents ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090320 ANDA ANDA077349 DZA Brands LLC IBUPROFEN 200 mg/1 N 20181231 55316-521_65130f01-6221-4c3a-bf1b-b8e5a93f2088 55316-521 HUMAN OTC DRUG healthy accents ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20160524 ANDA ANDA076359 DZA Brands LLC IBUPROFEN 100 mg/1 N 20181231 55316-541_3747569a-1063-456a-a4af-d0d9967166dc 55316-541 HUMAN OTC DRUG healthy accents cortisone maximum strength Hydrocortisone CREAM TOPICAL 20100825 OTC MONOGRAPH NOT FINAL part348 DZA Brands LLC HYDROCORTISONE 1 g/100g N 20181231 55316-544_7a5f6557-840b-48cb-bf87-18e9a8ce1bbd 55316-544 HUMAN OTC DRUG healthy accents arthritis pain relief Acetaminophen TABLET, FILM COATED, 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hydrochloride TABLET, FILM COATED ORAL 20110615 ANDA ANDA076447 DZA Brands LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 55316-578_a53c3ff3-fb5c-4a4c-849f-cc5ae73d864f 55316-578 HUMAN OTC DRUG healthy accents tussin dm adult sugar free Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20080303 OTC MONOGRAPH FINAL part341 DZA Brands LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 55316-580_4b337998-550f-41df-87bf-9f9db801335d 55316-580 HUMAN OTC DRUG Healthy Accents Daytime Nighttime Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140530 OTC MONOGRAPH FINAL part341 DZA Brands LLC N 20181231 55316-586_b0cdc87f-1726-40b8-ab1e-22ee77043a8a 55316-586 HUMAN OTC DRUG Healthy Accents allergy relief Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20160720 ANDA ANDA078336 DZA Brands LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55316-595_11b5f846-7e6e-4565-8800-bc6b76933918 55316-595 HUMAN OTC DRUG Healthy 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1 g/g N 20181231 55316-604_2cdf93d6-ee77-4490-9587-0345aa69394e 55316-604 HUMAN OTC DRUG healthy accents ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20080122 ANDA ANDA072096 DZA Brands LLC IBUPROFEN 200 mg/1 N 20181231 55316-610_e9f02f5c-d588-4d7b-9c8c-32526c93b4fd 55316-610 HUMAN OTC DRUG HEALTHY ACCENTS MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20100929 OTC MONOGRAPH FINAL part358H DZA Brands LLC SELENIUM SULFIDE 1 mL/100mL N 20181231 55316-612_aa1c22da-ce55-4ae5-9a1b-01474511381b 55316-612 HUMAN OTC DRUG Healthy accents allergy relief Loratadine TABLET ORAL 20071215 ANDA ANDA076301 DZA Brands LLC LORATADINE 10 mg/1 N 20181231 55316-619_2e3eee79-4b5f-441d-a86c-510613ca9d37 55316-619 HUMAN OTC DRUG HEALTHY ACCENTS MEDICATED DANDRUFF SELENIUM SULFIDE LIQUID TOPICAL 20140817 OTC MONOGRAPH FINAL part358H DZA BRANDS LLC SELENIUM SULFIDE 10 mg/mL N 20181231 55316-620_7dcdc60d-4311-4aca-b632-9f45081bd2f0 55316-620 HUMAN OTC DRUG HEALTHY ACCENTS SELENIUM SULFIDE LIQUID TOPICAL 20130702 OTC MONOGRAPH FINAL part358H DZA BRANDS LLC SELENIUM SULFIDE 10 mg/mL N 20181231 55316-621_f07bd5b3-dfa0-481c-94f6-41354d7df8f4 55316-621 HUMAN OTC DRUG Motion Sickness II Meclizine HCl TABLET ORAL 20131230 OTC MONOGRAPH FINAL part336 Healthy Accents (DZA Brands, LLC) MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 55316-622_020e139a-6f0a-4c18-8169-d95e9b5dc7f4 55316-622 HUMAN OTC DRUG Healthy Accents Anti Itch Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20100721 OTC MONOGRAPH NOT FINAL part348 DZA Brands LLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 55316-645_7e7b73bb-37ef-435b-97b3-7bad2ee161d0 55316-645 HUMAN OTC DRUG Healthy Accents Anti Diarrheal loperamide HCl SUSPENSION ORAL 20170223 ANDA ANDA091292 DZA Brands LLC LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 55316-647_03a64266-8989-4540-a8a4-377c8e00fd58 55316-647 HUMAN OTC DRUG Healthy Accents ibuprofen Ibuprofen TABLET, COATED ORAL 20080517 ANDA ANDA072096 DZA Brands LLC IBUPROFEN 200 mg/1 N 20181231 55316-648_68198940-3e33-402a-a748-f057c4196399 55316-648 HUMAN OTC DRUG Healthy Accents Nasal Phenylephrine hydrochloride SPRAY NASAL 20080211 OTC MONOGRAPH FINAL part341 DZA Brands LLC PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 55316-656_92a59b0b-a432-4a82-b87b-c973f4005fc4 55316-656 HUMAN OTC DRUG healthy accents daytime acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20080129 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 55316-664_1f9f1f82-a9ff-45fa-8aa0-89c97f99b2ad 55316-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20080205 OTC MONOGRAPH NOT FINAL part356 DZA Brands LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55316-666_dcd96d41-ed4d-43ed-90ed-2e26c2c4e024 55316-666 HUMAN OTC DRUG healthy accents cough and sore throat night time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20080224 20180212 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 55316-667_e7b47646-52d6-4d73-b76f-c454ed37addf 55316-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20071022 OTC MONOGRAPH FINAL part334 DZA Brads, LLC MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 55316-668_04198ecb-69d3-42b0-b611-f9c661be9ede 55316-668 HUMAN OTC DRUG Healthy Accents Night Time Cough Dextromethorphan Hydrobromide, Doxylamine Succinate SOLUTION ORAL 20080129 OTC MONOGRAPH FINAL part341 DZA Brands LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 55316-679_f30ce65e-24aa-47ad-a807-ad9f49fc23ba 55316-679 HUMAN OTC DRUG healthy accents triple antibiotic Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20101208 OTC MONOGRAPH FINAL part333B DZA Brands LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 55316-690_bf8802af-d8b6-426f-acdd-1b65806e2720 55316-690 HUMAN OTC DRUG Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20131230 OTC MONOGRAPH FINAL part336 Healthy Accents (DZA Brands, LLC) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55316-699_8e83fd57-7489-4c9b-96b8-0792f7633cd7 55316-699 HUMAN OTC DRUG healthy accents naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20080122 ANDA ANDA074661 DZA Brands LLC NAPROXEN SODIUM 220 mg/1 N 20181231 55316-701_0fd7ecce-a800-4dc0-8e5e-706980716190 55316-701 HUMAN OTC DRUG Healthy Accents Naproxen Sodium Naproxen Sodium TABLET ORAL 20110719 ANDA ANDA074661 DZA Brands LLC NAPROXEN SODIUM 220 mg/1 N 20181231 55316-719_20b78650-e4bc-400c-808c-96810e668592 55316-719 HUMAN OTC DRUG Healthy Accents Allergy Relief Fluticasone propionate SPRAY, METERED NASAL 20160729 ANDA ANDA207957 DZA Brands LLC FLUTICASONE PROPIONATE 50 ug/1 N 20181231 55316-735_a8d4c975-fd97-4f13-8a13-82a1db73b405 55316-735 HUMAN OTC DRUG Healthy Accents Mucus Relief DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160811 ANDA ANDA091070 DZA Brands LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 55316-799_66d15767-07ff-4d9b-9560-3c9eedd2fc25 55316-799 HUMAN OTC DRUG Healthy Accents Mucus Relief Severe Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140806 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55316-801_58f95350-0364-4d6b-ac49-5cd971b24981 55316-801 HUMAN OTC DRUG Healthy Accents Antibacterial Body Wash Spring Fresh Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E DZA Brands, LLC TRICLOSAN .15 mL/100mL N 20181231 55316-815_77a2e0e3-43ae-4df9-8656-bb717ea37b29 55316-815 HUMAN OTC DRUG HEALTHY ACCENTS ANTIBACTERIAL WASH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160308 OTC MONOGRAPH NOT FINAL part333E DZA BRANDS LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55316-822_475ddfc5-1d3e-45ab-83a5-f28d070b16f9 55316-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20080131 OTC MONOGRAPH FINAL part347 DZA Brands WITCH HAZEL 86 kg/100L N 20181231 55316-825_c2d5e9c3-f621-425f-93e3-d61f9ef1f4c7 55316-825 HUMAN OTC DRUG healthy accents miconazole 7 Miconazole nitrate CREAM VAGINAL 20141203 ANDA ANDA074760 DZA Brands LLC MICONAZOLE NITRATE 2 g/100g N 20181231 55316-829_3062db68-4378-4332-ab50-9c7e1414aa72 55316-829 HUMAN OTC DRUG Healthy Accents Antifungal Clotrimazole CREAM TOPICAL 20160726 OTC MONOGRAPH FINAL part333C DZA Brands LLC CLOTRIMAZOLE 10 g/g N 20181231 55316-831_512780ec-4688-4b17-b0f8-daee27bc7214 55316-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 20071022 OTC MONOGRAPH NOT FINAL part334 DZA Brands LLC MINERAL OIL 999 mg/mL N 20181231 55316-851_c57993f5-0227-4fec-b53c-a3373c8d14a7 55316-851 HUMAN OTC DRUG healthy accents maldroxal Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20080129 OTC MONOGRAPH FINAL part332 DZA Brands LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 55316-852_9db52eb8-0a52-4ba8-9637-1c2b1fb898af 55316-852 HUMAN OTC DRUG Healthy Accents Ranitidine Ranitidine TABLET, FILM COATED ORAL 20131009 ANDA ANDA091429 DZA Brands LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 55316-871_a96e8e23-09f3-4809-9de8-8b9067281d84 55316-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20090122 OTC MONOGRAPH NOT FINAL part333A DZA Brands, HYDROGEN PEROXIDE .3 kg/100L N 20181231 55316-881_96b1c71b-3f7b-4f2a-8cb4-caac6b896fa4 55316-881 HUMAN OTC DRUG healthy accents antacid calcium carbonate TABLET, CHEWABLE ORAL 20150414 OTC MONOGRAPH FINAL part331 DZA Brands LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 55316-882_9d0fbdde-1685-45ba-8dda-e5d9f44078bf 55316-882 HUMAN OTC DRUG Healthy Accents Gas Relief Simethicone EMULSION ORAL 20080224 OTC MONOGRAPH FINAL part332 DZA Brands LLC DIMETHICONE 20 mg/.3mL N 20181231 55316-886_50842350-404a-47e0-a45c-8d27d57fc3cb 55316-886 HUMAN OTC DRUG healthy accents sinus congestion and pain daytime nighttime Acetaminophen,Phenylephrine HCl, Chlorpheniramine maleate KIT 20111010 OTC MONOGRAPH FINAL part341 DZA Brands LLC N 20181231 55316-886_8a3e5c67-b140-4d8e-83ba-1652c5f87e2d 55316-886 HUMAN OTC DRUG healthy accents sinus Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20080310 OTC MONOGRAPH FINAL part341 DZA Brands LLC N 20181231 55316-897_c0f775d3-5376-47d1-af45-2657aa9069b2 55316-897 HUMAN OTC DRUG healthy accents ibuprofen Ibuprofen SUSPENSION ORAL 20080303 ANDA ANDA074937 DZA Brands LLC IBUPROFEN 100 mg/5mL N 20181231 55316-898_41ecbd1e-78b3-4b4a-b3ba-4d6d09ea1396 55316-898 HUMAN OTC DRUG healthy accents esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170928 ANDA ANDA207193 DZA Brands LLC ESOMEPRAZOLE 20 mg/1 N 20181231 55316-903_ef2d6a82-cd71-4bfa-ab9b-e774d6a4534e 55316-903 HUMAN OTC DRUG healthy accents multi symptom cold Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20110606 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 55316-906_152a156c-43e5-42d5-afa6-fdeefb5fdd26 55316-906 HUMAN OTC DRUG healthy accents cold and allergy childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20080401 OTC MONOGRAPH FINAL part341 DZA Brands LLC PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 55316-915_1e038768-5097-4c0b-82eb-f6145ac76c02 55316-915 HUMAN OTC DRUG healthy accents omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080303 NDA NDA022032 DZA Brands LLC OMEPRAZOLE 20 mg/1 N 20181231 55316-936_fbf14f8b-b8af-464c-99d3-3d3c6f1a0541 55316-936 HUMAN OTC DRUG Healthy Accents Sinus Relief Acetaminophen, guaifenesin, diphenhydramine HCl, phenylephrine HCl KIT 20150206 OTC MONOGRAPH FINAL part341 DZA Brands LLC N 20181231 55316-942_9ee115c9-5a93-4873-a769-3d94bb65b381 55316-942 HUMAN OTC DRUG Health Cetylpyridinium chloride MOUTHWASH ORAL 20150403 OTC MONOGRAPH NOT FINAL part356 DZA Brands LLC CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 55316-947_3b6b7f06-1216-4083-bd4c-e7146867f6a8 55316-947 HUMAN OTC DRUG Oil Free Acne Wash Salicylic Acid 2% LOTION TOPICAL 20101209 OTC MONOGRAPH FINAL part333D DZA BRANDS, LLC SALICYLIC ACID 20.6 mg/mL N 20181231 55316-949_af7cc64a-060d-4619-b085-614dd07bef85 55316-949 HUMAN OTC DRUG Healthy Accents Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20080122 OTC MONOGRAPH NOT FINAL part334 DZA Brands LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 55316-951_35c1b9e7-8ace-4f25-8632-a611264edd56 55316-951 HUMAN OTC DRUG Hand Sanitizer ALCOHOL GEL TOPICAL 20110520 OTC MONOGRAPH NOT FINAL part333A DZA Brands LLC ALCOHOL .65 kg/100L N 20181231 55316-952_a0b261b1-4b12-468d-aa5a-54d901ec63e2 55316-952 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20150206 OTC MONOGRAPH NOT FINAL part333A DZA Brands BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 55316-962_3d297f92-3619-4b00-bdab-43ac5a8998be 55316-962 HUMAN OTC DRUG healthy accents antacid Calcium carbonate TABLET, CHEWABLE ORAL 20150414 OTC MONOGRAPH FINAL part331 DZA Brands LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 55316-964_21d5c425-e90b-408d-b519-ca5ee368d6ce 55316-964 HUMAN OTC DRUG Healthy Accents Severe Cold Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20150917 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 55316-966_2549d902-9e17-4280-8a00-cb9f1777c935 55316-966 HUMAN OTC DRUG Healthy Accents Arthritis Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130516 ANDA ANDA075077 DZA Brands LLC ACETAMINOPHEN 650 mg/1 N 20181231 55316-987_ee263bfc-9990-432f-9f65-7bfff0cf640a 55316-987 HUMAN OTC DRUG healthy accents cold and cough DM Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20080806 OTC MONOGRAPH FINAL part341 DZA Brands LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 55316-994_8ecf14ef-3cd5-478e-8acc-f34e02f97772 55316-994 HUMAN OTC DRUG healthy accents daytime acetaminophen, dextromethorphan hbr, phenylephrine hcl CAPSULE, LIQUID FILLED ORAL 20080524 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55316-997_57e85fd6-4734-4d29-9817-6d5479a24c20 55316-997 HUMAN OTC DRUG healthy accents sinus relief Acetaminophen, guaifenesin, phenylephrine HCl CAPSULE, COATED ORAL 20150206 OTC MONOGRAPH FINAL part341 DZA Brands LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 55316-998_a2ce4ea1-702f-4942-96d9-134701da6af9 55316-998 HUMAN OTC DRUG healthy accents allergy relief fexofenadine hcl TABLET, FILM COATED ORAL 20110615 ANDA ANDA076447 DZA Brands LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 55319-001_c1798d1c-dffc-4d2d-88c2-ff08fafb1dd0 55319-001 HUMAN OTC DRUG Severe Cold Multi Symptom Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 55319-004_6a16410b-afda-4577-95f8-1c4806384d29 55319-004 HUMAN OTC DRUG Anticavity Rinse Sodium Fluoride MOUTHWASH ORAL 20110802 OTC MONOGRAPH FINAL part355 Family Dollar Services, Inc SODIUM FLUORIDE .2 mg/mL N 20191231 55319-005_26911f36-3dc9-4858-aebf-53af5db2528a 55319-005 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 FAMILY DOLLAR STORES, INC. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 55319-006_5ad0631d-41cf-35eb-e053-2a91aa0ab4f0 55319-006 HUMAN OTC DRUG Menthol cough drops menthol LOZENGE ORAL 20130524 OTC MONOGRAPH FINAL part341 Family Dollar MENTHOL 5.4 mg/1 N 20181231 55319-006_5ad0ad76-7a3e-3870-e053-2991aa0a3c27 55319-006 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20130524 OTC MONOGRAPH FINAL part341 Family Dollar MENTHOL 5.4 mg/1 N 20181231 55319-007_5ad11b1a-776c-0ad1-e053-2a91aa0a6f2e 55319-007 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20130524 OTC MONOGRAPH FINAL part341 Family Dollar MENTHOL 5.8 mg/1 N 20181231 55319-007_5ad1dba6-6acd-5d91-e053-2991aa0a6388 55319-007 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20130524 OTC MONOGRAPH FINAL part341 Family Dollar MENTHOL 5.8 mg/1 N 20181231 55319-008_5ad22a2c-00c2-157d-e053-2a91aa0aed67 55319-008 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20130524 OTC MONOGRAPH FINAL part341 Family Dollar MENTHOL 7.5 mg/1 N 20181231 55319-008_5ad277ae-0420-1207-e053-2a91aa0afbde 55319-008 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20130524 OTC MONOGRAPH FINAL part341 Family Dollar MENTHOL 7.5 mg/1 N 20181231 55319-009_5ae22440-c75d-9199-e053-2991aa0acad8 55319-009 HUMAN OTC DRUG sugar free honey lemon cough drop menthol LOZENGE ORAL 20160921 OTC MONOGRAPH FINAL part341 Family Dollar MENTHOL 7.6 mg/1 N 20181231 55319-010_5ae26456-661f-3169-e053-2991aa0a5065 55319-010 HUMAN OTC DRUG Herbal cough drops menthol LOZENGE ORAL 20150605 OTC MONOGRAPH FINAL part341 Family Dollar MENTHOL 4.8 mg/1 N 20181231 55319-011_5ae2ee9f-b506-e2bd-e053-2991aa0ab0e3 55319-011 HUMAN OTC DRUG Mixed Berry sore throat and cough lozenge Benzocaine LOZENGE ORAL 20160329 OTC MONOGRAPH NOT FINAL part356 Family Dollar BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20181231 55319-012_639f4e01-9728-a619-e053-2991aa0a549a 55319-012 HUMAN OTC DRUG Berry Breezer Throat Relief Drop Pectin LOZENGE ORAL 20180125 OTC MONOGRAPH NOT FINAL part356 Family Dollar PECTIN 7 mg/1 N 20191231 55319-013_aa669e2c-aa36-4e91-8a42-d16f0a9e2720 55319-013 HUMAN OTC DRUG FAMILY DOLLAR Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130730 OTC MONOGRAPH FINAL part350 FAMILY DOLLAR ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g E 20171231 55319-014_5fe45576-8e75-4955-8221-a101f87c116c 55319-014 HUMAN OTC DRUG FAMILY DOLLAR Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20111024 OTC MONOGRAPH FINAL part350 FAMILY DOLLAR ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g E 20171231 55319-016_63a11550-3886-ac02-e053-2991aa0af56d 55319-016 HUMAN OTC DRUG Cherry Antacid Soft Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20180125 OTC MONOGRAPH FINAL part331 Family Dollar CALCIUM CARBONATE 1177 mg/1 N 20191231 55319-017_63b2ede2-17c0-cdf7-e053-2a91aa0a5cbf 55319-017 HUMAN OTC DRUG Antacid Fruit Flavor Chews Calcium Carbonate LOZENGE ORAL 20180126 OTC MONOGRAPH FINAL part331 Family Dollar CALCIUM CARBONATE 750 mg/1 N 20191231 55319-018_63b3cda4-dfb2-5a62-e053-2991aa0ab610 55319-018 HUMAN OTC DRUG Antacid Anti-Gas Relief Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20180126 OTC MONOGRAPH FINAL part331 Family Dollar DIMETHICONE; CALCIUM CARBONATE 80; 750 mg/1; mg/1 N 20191231 55319-019_2d335622-0b66-409f-ac7a-d4b54f60ff4b 55319-019 HUMAN OTC DRUG family wellness allergy relief nasal Fluticasone propionate SPRAY, METERED NASAL 20170330 ANDA ANDA207957 Family Dollar Services Inc FLUTICASONE PROPIONATE 50 ug/1 N 20191231 55319-020_63b47e0b-455f-16a5-e053-2991aa0aa8cd 55319-020 HUMAN OTC DRUG Antacid Fruit Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20180126 OTC MONOGRAPH FINAL part331 Family Dollar CALCIUM CARBONATE 750 mg/1 N 20191231 55319-026_44a22089-975b-4f32-aa2a-ec2af7b1c0a9 55319-026 HUMAN OTC DRUG FAMILY WELLNESS COLD AND HOT PAIN RELIEF MENTHOL PATCH TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part348 FAMILY DOLLAR MENTHOL 750 mg/1 N 20181231 55319-029_f0b10cfc-624a-4459-8746-28c68484fcad 55319-029 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150531 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 55319-031_a9bd4fd0-da7a-4fa1-b7e5-5b55b88a03e3 55319-031 HUMAN OTC DRUG FAMILY WELLNESS MEDICATED WIPES WITCH HAZEL SOLUTION TOPICAL 20120930 OTC MONOGRAPH FINAL part346 FAMILY DOLLAR WITCH HAZEL 5 g/1 N 20181231 55319-032_46b404c3-ab4c-467f-a4cb-117646c405c8 55319-032 HUMAN OTC DRUG FAMILY WELLNESS MEDICATED COOLING PADS WITCH HAZEL SOLUTION TOPICAL 20120930 OTC MONOGRAPH FINAL part346 FAMILY DOLLAR WITCH HAZEL 5 g/1 N 20181231 55319-033_63131d41-c3ef-41bf-e053-2a91aa0ada67 55319-033 HUMAN OTC DRUG FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine HCI CREAM TOPICAL 20121015 OTC MONOGRAPH FINAL part333B FAMILY DOLLAR NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g N 20191231 55319-035_e27f3b0e-9c92-4c02-a124-87bfa892918a 55319-035 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20150504 ANDA ANDA076460 Family Dollar (FAMILY WELLNESS) IBUPROFEN 200 mg/1 N 20181231 55319-041_b29c066b-42c0-49e4-a9aa-a76d8a93aa02 55319-041 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen CAPSULE ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN 500 mg/1 N 20181231 55319-044_13941e26-dd7e-4546-ae68-974c30bd6b06 55319-044 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170630 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) DOCUSATE SODIUM 100 mg/1 N 20181231 55319-045_9206cbec-0265-4b22-af9b-c35e6cc04fda 55319-045 HUMAN OTC DRUG Acetaminophen Rapid Tabs Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ACETAMINOPHEN 160 mg/1 N 20181231 55319-050_8da1acfd-1ce1-450d-8648-51d59614421b 55319-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, FILM COATED ORAL 20100407 ANDA ANDA079113 Family Dollar Services Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20191231 55319-055_e9cc4be5-2fe6-43b5-894b-f01ce4ff6b04 55319-055 HUMAN OTC DRUG Undecylenic Acid Antifungal Pen LIQUID TOPICAL 20171215 OTC MONOGRAPH FINAL part333C Family Dollar Services Inc. UNDECYLENIC ACID 25 mg/1.7mL N 20181231 55319-059_14e1c0a6-2081-4a1a-ba5f-e31c9463098b 55319-059 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN 500 mg/1 N 20181231 55319-063_6823232b-2a6f-4c07-86db-7e0d7eef5359 55319-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19890715 OTC MONOGRAPH FINAL part347 Family Dollar FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 55319-065_f036e0f7-022f-44b5-919a-68b57da5fada 55319-065 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, POWDER TOPICAL 20130110 OTC MONOGRAPH FINAL part333C Family Dollar Services Inc. TOLNAFTATE 1.3 g/130g N 20181231 55319-066_8cb92a13-2333-44b3-82bf-7a8b0aa74f29 55319-066 HUMAN OTC DRUG Daytime Cold and Flu Multi symptom relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20191231 55319-069_ddf8ef6b-20e9-45a3-af59-faf4295ff599 55319-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20090105 OTC MONOGRAPH FINAL part347 Family Dollar Services, Inc PETROLATUM 1 g/g N 20181231 55319-071_530799d5-f6d6-48ca-be92-39423072b9d7 55319-071 HUMAN OTC DRUG Isopropyl alcohol 50 percent Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A Family Dollar (FAMILY WELLNESS) ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 55319-072_65cb1e2a-ac23-48c2-9a3e-1080d0668730 55319-072 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50 percent Wintergreen Isopropyl alcohol LIQUID TOPICAL 20140831 OTC MONOGRAPH NOT FINAL part333A Family Dollar (FAMILY WELLNESS) ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 55319-074_0634f2d0-5577-4df8-a282-d08c90e52422 55319-074 HUMAN OTC DRUG Family Wellness Maximum Strength Hydrocortisone Hydrocortisone CREAM TOPICAL 20130819 OTC MONOGRAPH NOT FINAL part348 Family Dollar HYDROCORTISONE 1 g/100g N 20181231 55319-079_c2998ff0-479c-4c87-8a96-b4b824184253 55319-079 HUMAN OTC DRUG Childrens Cold and Cough Nighttime Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 55319-081_aa75231d-0bf5-443a-9c90-744fd99461c5 55319-081 HUMAN OTC DRUG Family Wellness Miconazole 3 Miconazole nitrate KIT 20130329 ANDA ANDA075329 Family Dollar Services Inc N 20181231 55319-084_de1cd177-d068-458d-ba07-d2ac5fa7edf9 55319-084 HUMAN OTC DRUG Stool Softener with Stimulant Laxative Docusate sodium, Sennosides TABLET ORAL 20151130 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 55319-092_f16f468f-ac5c-40bb-afe9-92c978e4a37c 55319-092 HUMAN OTC DRUG Childrens Allergy Diphenhydramine HCl LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 55319-099_57af2463-23e1-4c24-a578-626c6935431d 55319-099 HUMAN OTC DRUG family wellness allergy relief Loratadine TABLET ORAL 20160614 ANDA ANDA076301 Family Dollar Services Inc LORATADINE 10 mg/1 N 20181231 55319-100_c185f1bf-5c07-4671-ad3b-bb52f07cbe2a 55319-100 HUMAN OTC DRUG Medicated Chest Rub Camphor, Menthol, Eucalyptus Oil CREAM TOPICAL 20110719 OTC MONOGRAPH FINAL part348 Family Dollar Services Inc CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.8; 2.6; 1.2 g/100g; g/100g; g/100g N 20181231 55319-101_5de54ab8-780c-4daf-9758-844aa02040bc 55319-101 HUMAN OTC DRUG Medicated Chest Rub Family Wellness Camphor, Menthol, Eucalyptus Oil CREAM TOPICAL 20110719 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.8; 2.6; 1.2 g/100g; g/100g; g/100g N 20191231 55319-102_3de44bf1-2c86-498c-8ca8-429e762ae647 55319-102 HUMAN OTC DRUG MEDICATED CHEST RUB camphor, menthol, eucalyptus oil CREAM TOPICAL 20110719 OTC MONOGRAPH NOT FINAL part348 Family Dollar Services Inc CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.8; 2.6; 1.2 g/100g; g/100g; g/100g N 20181231 55319-103_5d7cc3fd-df87-38a2-e053-2a91aa0a69fb 55319-103 HUMAN OTC DRUG Vitamin A and D Lanolin and Petrolatum OINTMENT TOPICAL 20171108 OTC MONOGRAPH FINAL part347 Family Dollar Services Inc LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g N 20181231 55319-107_e7a1fb43-d54b-4c82-9472-8adc28e28a3e 55319-107 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20140731 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) GUAIFENESIN 400 mg/1 N 20181231 55319-109_725c6a16-d493-4638-94df-c4d21745918f 55319-109 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr TABLET ORAL 20140731 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20191231 55319-110_6aba38ab-f1e0-4486-aaf4-7c2956703be5 55319-110 HUMAN OTC DRUG Bacitracin Zinc bacitracin zinc OINTMENT TOPICAL 20120223 OTC MONOGRAPH FINAL part333B Family Dollar Services Inc. BACITRACIN ZINC 500 [USP'U]/g N 20181231 55319-111_08407b4b-bcdd-428a-84b2-d798760e3adc 55319-111 HUMAN OTC DRUG Maximum Strength Feminine Anti-Itch Family Wellness Benzocaine 20.00% Resorcinol 3.00% CREAM TOPICAL 20141128 OTC MONOGRAPH NOT FINAL part348 Family Dollar BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g N 20181231 55319-112_9c4df423-40a4-48ed-b41a-78698ebdf242 55319-112 HUMAN OTC DRUG Family Wellness Lice Treatment Piperonyl butoxide, pyrethrum extract KIT 20160520 OTC MONOGRAPH FINAL part358G Family Dollar Services Inc N 20181231 55319-125_49689a6f-c392-4f75-b1f8-1edf90719544 55319-125 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060804 20180228 ANDA ANDA074916 Family Dollar Services Inc. IBUPROFEN 100 mg/5mL N 20181231 55319-126_6b36d0d9-d6c4-4fd3-b6a3-eaea5481ad90 55319-126 HUMAN OTC DRUG Magnesium Citrate Saline Laxative Magnesium citrate LIQUID ORAL 20170630 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 55319-133_838e902f-e536-45ee-9cce-cb64d7f52ea9 55319-133 HUMAN OTC DRUG Family Dollar Complete Protection Anticavity Mouthwash Sodium Fluoride MOUTHWASH ORAL 20110516 OTC MONOGRAPH FINAL part356 Family Dollar SODIUM FLUORIDE .0221 g/100g E 20171231 55319-153_8c1efcb8-4f26-43d3-b52e-8103195abb5f 55319-153 HUMAN OTC DRUG Dandruff Daily Care Pyrithione Zinc SHAMPOO TOPICAL 19980605 OTC MONOGRAPH FINAL part358H Family Dollar Services, Inc PYRITHIONE ZINC 1 kg/100L N 20181231 55319-154_10e1f279-bc6e-4e63-9012-ef14f4da599c 55319-154 HUMAN OTC DRUG 2in1 Dandruff and Conditioner pyrithione zinc SHAMPOO TOPICAL 20120715 OTC MONOGRAPH FINAL part358H Family Dollar PYRITHIONE ZINC 1 mL/100mL N 20181231 55319-156_460f6eb5-e5e9-4829-bb6b-1cea31ceac54 55319-156 HUMAN OTC DRUG Family Dollar Antibacterial Triclosan SOAP TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. TRICLOSAN .15 g/100mL E 20171231 55319-159_fef590fd-6e90-4e77-bbe6-85037fb5a38b 55319-159 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19921117 20190708 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 E 20171231 55319-161_95cc004b-5bf9-43d8-8995-0e1e725d3c90 55319-161 HUMAN OTC DRUG Family Dollar Foaming Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20131230 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. TRICLOSAN .46 g/100mL E 20171231 55319-162_185f3c88-9e03-4106-bd13-38eae2155ec9 55319-162 HUMAN OTC DRUG Family Dollar Foaming Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20131230 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. TRICLOSAN .46 g/100mL E 20171231 55319-163_39836ee5-640c-4c0b-9c93-c30e2baddf1a 55319-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20111214 OTC MONOGRAPH FINAL part355 Family Dollar Services, Inc SODIUM FLUORIDE .1 mg/mL N 20181231 55319-168_6301f617-7cf6-418d-b10d-f1c5f27b74ff 55319-168 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20120815 ANDA ANDA079096 Family Dollar (FAMILY WELLNESS) NAPROXEN SODIUM 220 mg/1 N 20181231 55319-169_ec7422b2-1639-41fc-b3a0-2b85e8ba9f54 55319-169 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20131101 ANDA ANDA079096 Family Dollar (FAMILY WELLNESS) NAPROXEN SODIUM 220 mg/1 N 20181231 55319-174_6e0b194e-2eff-49ff-9b48-9d91bf1510ff 55319-174 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20171231 NDA NDA021920 Family Dollar (FAMILY WELLNESS) NAPROXEN SODIUM 220 mg/1 N 20191231 55319-175_1e1b1729-69d4-4f93-97a0-85189561f56a 55319-175 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen TABLET, FILM COATED ORAL 19930402 20180708 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ACETAMINOPHEN 500 mg/1 N 20181231 55319-179_fb447f5f-4d68-4fc1-b9ad-8989bd71d021 55319-179 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL part333B Family Dollar Services Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 55319-180_6017631f-f2a3-d534-e053-2991aa0ace2a 55319-180 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid LIQUID TOPICAL 20170630 OTC MONOGRAPH FINAL part358F Family Dollar Services Inc. SALICYLIC ACID .17 g/9mL N 20181231 55319-182_60169edc-3dda-fd7a-e053-2991aa0a5f7e 55319-182 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20131001 OTC MONOGRAPH FINAL part333C Family Dollar Services Inc. TOLNAFTATE 1.5 g/150.2g N 20181231 55319-184_e20a8b93-d9a2-456a-a554-2c680bc337f0 55319-184 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20120401 OTC MONOGRAPH FINAL part358F Family Dollar Services Inc. SALICYLIC ACID 40 mg/1 N 20181231 55319-186_a26c8bd7-7e58-4925-b800-087a9d8de550 55319-186 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20150504 ANDA ANDA076460 Family Dollar (FAMILY WELLNESS) IBUPROFEN 200 mg/1 N 20181231 55319-190_7599cd7c-d94c-4f1f-952f-31941d8cf819 55319-190 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 20191025 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55319-194_dcfef89c-6cc1-40b7-bc25-551da95e8733 55319-194 HUMAN OTC DRUG Allergy Relief Chlorpheniramine Maleate TABLET ORAL 19921219 20190708 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 55319-195_9242820d-5eae-46f9-a34a-63336f8747a1 55319-195 HUMAN OTC DRUG Laxative Bisacodyl TABLET, COATED ORAL 20130630 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) BISACODYL 5 mg/1 N 20181231 55319-199_c7efc28a-ab38-489f-be38-aea2237cdda5 55319-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170630 ANDA ANDA078682 Family Dollar (FAMILY WELLNESS) IBUPROFEN 200 mg/1 N 20181231 55319-203_74de7a42-ba8f-40df-9792-98cfc4525afb 55319-203 HUMAN OTC DRUG FAMILY DOLLAR ACNE TREATMENT BENZOYL PEROXIDE CREAM TOPICAL 20120120 OTC MONOGRAPH FINAL part333D FAMILY DOLLAR BENZOYL PEROXIDE 10 g/100g N 20181231 55319-205_5dea8e85-dcf1-46c4-bc30-e8ee2652d630 55319-205 HUMAN OTC DRUG Therapeutic T Plus Coal Tar SHAMPOO TOPICAL 20050304 OTC MONOGRAPH FINAL part358H Family Dollar Services Inc COAL TAR 25 mg/mL N 20181231 55319-212_97341677-d544-4595-9068-6cf9937f5631 55319-212 HUMAN OTC DRUG Pain Reliever Sleep Aid Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20131104 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55319-213_783f2c5b-a548-4c5a-a9b6-d088fc55ab48 55319-213 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20050223 OTC MONOGRAPH FINAL part355 Family Dollar Servicesm Inc SODIUM FLUORIDE .05 kg/100L N 20181231 55319-218_01ab1b4e-ffae-4935-a853-171d0fbaae03 55319-218 HUMAN OTC DRUG Chewable Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ASPIRIN 81 mg/1 N 20181231 55319-224_dca62593-20dd-49df-9100-c32e69acf860 55319-224 HUMAN OTC DRUG family wellness anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20030226 ANDA ANDA075232 Family Dollar Services Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 55319-225_a09ded9b-ee95-4860-b009-ae81f0ccd6ae 55319-225 HUMAN OTC DRUG EZ Nite Sleep Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20131030 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55319-226_ffb96b37-2bf2-4900-81ba-4371df41ef02 55319-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 Family Dollar Services Inc CAFFEINE 200 mg/1 N 20181231 55319-227_de8418a9-4ddd-43db-8e93-2729a466ad93 55319-227 HUMAN OTC DRUG Low Dose Aspirin 81 mg Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ASPIRIN 81 mg/1 N 20181231 55319-235_e157c895-4b7b-4371-b327-d2627726b2d9 55319-235 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 20191219 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55319-236_f2abcc39-347a-4e17-be1b-d0ee2ebea138 55319-236 HUMAN OTC DRUG Sleep Aid Nighttime Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 55319-237_e8d6f123-171b-4d93-a8a8-9c28f7454e02 55319-237 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl CAPSULE ORAL 20140731 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55319-238_61b86693-becb-4e95-8626-6bf8384ddf9b 55319-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130830 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) DOCUSATE SODIUM 100 mg/1 N 20181231 55319-240_d877edd8-bdb4-4717-893b-371a90d17eeb 55319-240 HUMAN OTC DRUG Family Dollar Roll-On Deodorant Aluminum Chlorohydrate LOTION TOPICAL 20140502 OTC MONOGRAPH FINAL part350 Family Dollar Services,Inc. ALUMINUM CHLOROHYDRATE 160 mg/mL E 20171231 55319-242_18d4fa6d-66d1-4da6-9e24-215c281e58bf 55319-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131130 20181231 OTC MONOGRAPH FINAL part347 Family Dollar (FAMILY WELLNESS) DIMETHICONE 125 mg/1 N 20181231 55319-243_69b8d51a-5829-45ff-9412-c8a590eec617 55319-243 HUMAN OTC DRUG Antibacterial Hand Triclosan LIQUID TOPICAL 20090106 OTC MONOGRAPH FINAL part333A Family Dollar Services Inc TRICLOSAN .15 kg/100L N 20181231 55319-244_7aabf8bf-b725-41d3-a1ea-a3cd3ff3faa6 55319-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) DOCUSATE SODIUM 100 mg/1 N 20181231 55319-247_127c7ea5-fb55-45d1-b719-bfaa565abcf9 55319-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55319-248_3b0578b2-92a9-426d-9498-3dc560413583 55319-248 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20140630 ANDA ANDA079174 Family Dollar (FAMILY WELLNESS) IBUPROFEN 200 mg/1 N 20181231 55319-249_6740bc2d-1ad1-4d17-9f26-eeb13dad79f0 55319-249 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20140731 ANDA ANDA076460 Family Dollar (FAMILY WELLNESS) IBUPROFEN 200 mg/1 N 20181231 55319-250_71a1b6eb-f577-4dac-992d-ca11fd48f12a 55319-250 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION ORAL 20120222 ANDA ANDA079058 Family Dollar Services Inc. IBUPROFEN 50 mg/1.25mL N 20181231 55319-255_1f88bf14-6dfb-4eca-b0b3-f2713c92a05c 55319-255 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140430 ANDA ANDA091353 Family Dollar (FAMILY WELLNESS) NAPROXEN SODIUM 220 mg/1 N 20191231 55319-256_21aa5ebf-5821-46e5-9245-6d10dffe7913 55319-256 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140430 ANDA ANDA091353 Family Dollar (FAMILY WELLNESS) NAPROXEN SODIUM 220 mg/1 N 20191231 55319-263_4a5ff58e-fd67-4fe0-a48b-6f5da917e125 55319-263 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20120223 20190831 ANDA ANDA074916 Family Dollar Services Inc. IBUPROFEN 100 mg/5mL N 20191231 55319-268_a25c8565-8c6f-46a9-8145-fcc5ca6c4881 55319-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20140831 OTC MONOGRAPH NOT FINAL part356 Family Dollar (FAMILY WELLNESS) HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 55319-272_9b332a13-44a5-44ec-9f7e-5c23cadb2855 55319-272 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A Family Dollar (FAMILY WELLNESS) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 55319-275_666cd5c2-348e-4e5e-836c-e26a1098b20c 55319-275 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20171231 OTC MONOGRAPH NOT FINAL part333A Family Dollar (FAMILY WELLNESS) ISOPROPYL ALCOHOL 70 mL/100mL N 20191231 55319-277_e231f091-4114-46c7-8d4b-b12a377c5268 55319-277 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A Family Dollar (FAMILY WELLNESS) ISOPROPYL ALCOHOL 91 mL/100mL N 20191231 55319-279_fa353c41-f5f1-4c92-9a06-3dbae13bd93a 55319-279 HUMAN OTC DRUG family wellness hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20141029 OTC MONOGRAPH FINAL part346 Family Dollar Services Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 55319-282_1adb250f-6312-4453-859e-87ff0ce72df0 55319-282 HUMAN OTC DRUG Childrens Pain Reliever Acetaminophen SUSPENSION ORAL 20150930 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN 160 mg/5mL N 20181231 55319-288_0e9a9179-5f51-4a93-84e5-70f01cfecb0a 55319-288 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20150228 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN 160 mg/5mL N 20181231 55319-292_b7a64511-16a9-4a29-9bb1-846e3880f460 55319-292 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 20190310 ANDA ANDA075010 Family Dollar Services Inc IBUPROFEN 200 mg/1 N 20181231 55319-294_bec7bb11-3707-482a-b9d5-622a172a3c72 55319-294 HUMAN OTC DRUG Mucus Relief Cough Childrens Dextromethorphan HBr, Guaifensin LIQUID ORAL 20160229 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 55319-296_dfe1a929-b0de-47d1-9c7c-2a9c59a90aad 55319-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20130122 OTC MONOGRAPH FINAL part358H Family Dollar Services, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 55319-299_96f7b725-73e4-435d-819c-36c8bbd6ec5c 55319-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20130502 OTC MONOGRAPH NOT FINAL part356 Family Dollar Services CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 55319-300_80fc79cd-6653-4d7e-ad10-bb46e939c35a 55319-300 HUMAN OTC DRUG Family Wellness Antifungal Tolnaftate CREAM TOPICAL 20140121 OTC MONOGRAPH FINAL part333C Family Dollar TOLNAFTATE 1 g/100g N 20181231 55319-304_d777013e-e95a-442a-ad47-5eac4a9fa7f1 55319-304 HUMAN OTC DRUG Childrens Plus Multi Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 55319-306_0f2fad1a-291f-4c10-a17e-3dc327c6cb97 55319-306 HUMAN OTC DRUG family wellness laxative Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20110621 ANDA ANDA090685 Family Dollar Services Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20191231 55319-312_af49bc2c-db10-413d-8606-cb7c5bf259ba 55319-312 HUMAN OTC DRUG Childrens Cold and Allergy Relief Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/10mL; mg/10mL N 20181231 55319-313_060a415d-f886-44bc-81fe-c34266e7ed2f 55319-313 HUMAN OTC DRUG Childrens Cold and Cough Relief Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20151031 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 55319-314_b8ecdb98-c2d5-4cd5-bb0c-9871066a3b9b 55319-314 HUMAN OTC DRUG Sleep Aid NightTime Diphenhydramine HCl LIQUID ORAL 20170731 OTC MONOGRAPH FINAL part338 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20191231 55319-316_23110bc3-8830-461c-89f4-6f9aae97af69 55319-316 HUMAN OTC DRUG Daytime Severe Cold and Cough Relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55319-317_a917b33f-6cf5-43ca-a5bb-3807ccac0385 55319-317 HUMAN OTC DRUG Flu Relief Therapy Night Time Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55319-318_c3fdf379-3b8f-429d-91db-b0cbee3b4a0f 55319-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19910122 OTC MONOGRAPH NOT FINAL part356 Family Dollar Services, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55319-321_373e5512-0058-46dd-86e9-ce533e3f3a79 55319-321 HUMAN OTC DRUG family wellness acid controller complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20120802 ANDA ANDA077355 Family Dollar Services Inc FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 55319-322_0018f07d-d5f0-490f-b803-34b867fca5f2 55319-322 HUMAN OTC DRUG Family Wellness Advanced Eye Dextran 70, Polyethylene Glycol 400, Povidone, and Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20140519 OTC MONOGRAPH FINAL part349 FAMILY DOLLAR DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55319-323_d5e0c2dc-a469-4166-9b27-af590c17a5d5 55319-323 HUMAN OTC DRUG FAMILY WELLNESS IRRITATION RELIEF AC EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE SOLUTION OPHTHALMIC 20121031 OTC MONOGRAPH FINAL part349 FAMILY DOLLAR TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL N 20181231 55319-325_e9df35b9-f1cf-4029-bff2-54aaba74522e 55319-325 HUMAN OTC DRUG Infants Gas Relief Simethicone SUSPENSION ORAL 20170228 OTC MONOGRAPH FINAL part332 Family Dollar (FAMILY WELLNESS) DIMETHICONE 20 mg/.3mL N 20181231 55319-326_4ba5af96-80d6-4e6f-8843-d025596eb015 55319-326 HUMAN OTC DRUG Laxative for Women Bisacodyl TABLET, COATED ORAL 20050212 20181214 OTC MONOGRAPH NOT FINAL part334 Family Dollar BISACODYL 5 mg/1 E 20171231 55319-329_74ceabfd-b265-4eba-82d8-c8c3edc3a032 55319-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55319-333_dfdf7a63-c957-4823-b417-accec8cc1a06 55319-333 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170901 ANDA ANDA076200 Family Dollar Services, Inc. ACETAMINOPHEN 650 mg/1 N 20191231 55319-334_b028f567-a09d-4dbd-b3dd-0fff8988c22b 55319-334 HUMAN OTC DRUG Family Wellness Antifungal Clotrimazole CREAM TOPICAL 20140120 OTC MONOGRAPH FINAL part333C Family Dollar CLOTRIMAZOLE 10 mg/g N 20181231 55319-336_1e42e134-54fa-4640-bf8d-cb620e1c11be 55319-336 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 650; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 55319-337_a8487e0c-3d79-4314-ba88-bdb0b9a020f2 55319-337 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 55319-342_1aff24ce-e458-4cd1-8b61-2d8ef708dbcc 55319-342 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20160229 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 55319-343_57e6cd1e-fdd5-099e-e053-2a91aa0af26e 55319-343 HUMAN OTC DRUG Hemorrhoidal COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20170801 OTC MONOGRAPH FINAL part346 FAMILY DOLLAR SERVICES INC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 1768.8; 5 mg/1; mg/1 N 20181231 55319-344_630ff629-2abd-41c8-a546-6ddefbeb2b77 55319-344 HUMAN OTC DRUG Night Time Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20171231 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20191231 55319-345_4a5e637e-a3f2-4f26-98d9-aedd74883209 55319-345 HUMAN OTC DRUG Night Time Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 55319-346_e4b9bb7c-6931-416b-8670-3b617a7a417e 55319-346 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 55319-348_42e68a6c-3f1a-44b9-b61f-6814c03b226d 55319-348 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET, SUGAR COATED ORAL 20030102 OTC MONOGRAPH NOT FINAL part334 Family Dollar Services Inc SENNOSIDES 25 mg/1 N 20181231 55319-351_bd2b1178-fb3b-4690-b7d0-a2622b91b2cb 55319-351 HUMAN OTC DRUG Regular Strength Acid Reducer Ranitidine TABLET ORAL 20110628 ANDA ANDA200536 Family Dollar RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 55319-352_3cff4f08-e8e4-4324-a08b-9970c25665c4 55319-352 HUMAN OTC DRUG Regular Strength Acid Reducer Ranitidine TABLET ORAL 20130924 ANDA ANDA201745 Family Dollar RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 55319-367_f02e3b3a-32b8-4f23-8102-fc2641d677c7 55319-367 HUMAN OTC DRUG Sleep Aid Nighttime Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 20191025 OTC MONOGRAPH FINAL part338 Family Dollar Services Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55319-371_2396f03e-2f3b-4f12-b4a0-1d001079a082 55319-371 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part335 Family Dollar (FAMILY WELLNESS) BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 55319-372_7acbfa73-ccfa-488f-b150-b8069fd7e815 55319-372 HUMAN OTC DRUG Stomach Relief Original Strength Bismuth subsalicylate LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part335 Family Dollar (FAMILY WELLNESS) BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 55319-374_3abf7666-8e86-4813-b3af-d7c3e81a70e4 55319-374 HUMAN OTC DRUG Family Wellness Migraine Relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20060410 ANDA ANDA075794 Family Dollar Services Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55319-375_2ba4b28f-8e04-4f69-ac53-6c15bac414ae 55319-375 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 Family Dollar Services Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 55319-376_8b89ae6c-86a3-43e9-b860-c18d930e107d 55319-376 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140630 OTC MONOGRAPH NOT FINAL part356 Family Dollar (FAMILY WELLNESS) PHENOL 1.4 g/100mL N 20181231 55319-377_08f195ec-c9cf-4dd2-befa-9f79c5345b24 55319-377 HUMAN OTC DRUG Family Wellness Acid Reducer Famotidine TABLET ORAL 20130830 ANDA ANDA077351 Family Dollar Services Inc FAMOTIDINE 20 mg/1 N 20181231 55319-378_a0f75101-cf3e-453d-813b-14c517dc3824 55319-378 HUMAN OTC DRUG Cold and Cough Day Time Childrens Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 55319-379_49e48286-010e-48fa-a454-aabeff49f629 55319-379 HUMAN OTC DRUG Childrens Nighttime Cold and Cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20140731 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 55319-382_4e7062cf-0623-4909-b42c-e20a081ba633 55319-382 HUMAN OTC DRUG Multi Symptom Cold CF Adult Dextromethorphan HBr, Guaifenesin, Phenylephrine LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 55319-385_e7467fc6-dbdd-41a7-bdde-85e4eb79ddfb 55319-385 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM Adult Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 55319-390_53c9eb4c-8382-4302-82ed-ce5ef707694b 55319-390 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140831 OTC MONOGRAPH FINAL part347 Family Dollar (FAMILY WELLNESS) WITCH HAZEL 842 mg/mL N 20181231 55319-391_f43eff89-c85b-440b-b432-2154e895e3ed 55319-391 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine, Pyrilamine maleate TABLET, FILM COATED ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 55319-393_cdf56e36-aadf-4f1e-b3be-5b5a1a6d0563 55319-393 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Family Dollar Services Inc IBUPROFEN 200 mg/1 N 20181231 55319-403_38848f8a-aede-4014-b660-e398b7a9e88f 55319-403 HUMAN OTC DRUG Less Drowsy Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 Family Dollar Services Inc MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 55319-404_a615dbe3-f7fd-4ca1-8d9b-195178185d83 55319-404 HUMAN OTC DRUG EZ Nite Sleep Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140731 OTC MONOGRAPH FINAL part338 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55319-411_36c0ba0c-4949-4da2-8e29-f5275db5bbec 55319-411 HUMAN OTC DRUG Cough and Cold HBP chlorpheniramine maleate and dextromethorphan hbr TABLET, SUGAR COATED ORAL 20030503 20200508 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 55319-414_1b2b1a44-8428-413c-8e61-a57be15b9fc6 55319-414 HUMAN OTC DRUG Tussin Nighttime Cough DM Maximum Strength Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20160731 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL N 20181231 55319-415_6ae78e51-7895-4a65-92f1-a399e0a56046 55319-415 HUMAN OTC DRUG Severe Cold and Flu Relief Daytime Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20171231 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20191231 55319-416_d786b6d4-030b-43a9-8e7d-761e5544e5cd 55319-416 HUMAN OTC DRUG Severe cold and flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI LIQUID ORAL 20151231 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 55319-421_60b5bef5-4c93-e07a-e053-2991aa0a193a 55319-421 HUMAN OTC DRUG Family Wellness Effervescent Antacid and Pain Relief Aspirin, Citric Acid, Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20170613 OTC MONOGRAPH FINAL part343 Family Wellness Services, Inc. ASPIRIN; ANHYDROUS CITRIC ACID; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 N 20191231 55319-425_c8349bf9-8785-472f-ad02-b6f42eb9fe63 55319-425 HUMAN OTC DRUG Stomach Relief Cherry Bismuth subsalicylate LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part335 Family Dollar (FAMILY WELLNESS) BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 55319-430_3fc6307d-dbc4-64eb-e054-00144ff8d46c 55319-430 HUMAN OTC DRUG Family Dollar antibacterial Benzethonium chloride LIQUID TOPICAL 20161019 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. BENZETHONIUM CHLORIDE .1 g/100mL N 20181231 55319-431_6141e157-0068-4f58-e053-2991aa0ad75f 55319-431 HUMAN OTC DRUG Modesa Moisturizing Hand ANTIBACTERIAL Benzethonium chloride LIQUID TOPICAL 20171218 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. BENZETHONIUM CHLORIDE .1 g/100mL N 20181231 55319-432_61be1b71-b2b2-b124-e053-2991aa0a32d8 55319-432 HUMAN OTC DRUG Hand Sanitizer with Moisturizers and Aloe Vera Modesa Ethyl Alcohol LIQUID TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. ALCOHOL 70 mL/100mL N 20191231 55319-443_8327b32c-353e-4356-9abe-ac1f8cb44046 55319-443 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20171231 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20191231 55319-447_b75a5892-a4c4-4183-8ab9-dc4580db194d 55319-447 HUMAN OTC DRUG Acetaminophen PM Extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20141130 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55319-450_9f204394-23b2-4594-a83e-4c51a87d7088 55319-450 HUMAN OTC DRUG Acetaminophen Rapid Tabs Junior Acetaminophen TABLET, CHEWABLE ORAL 20050225 20200410 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ACETAMINOPHEN 160 mg/1 N 20181231 55319-453_a9740b66-188c-4480-92e2-17e242f73858 55319-453 HUMAN OTC DRUG Suphedrine PE Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 55319-454_a19d011c-9ff7-4ef9-8c97-8d1d9239ac38 55319-454 HUMAN OTC DRUG FAMILY WELLNESS ANTIFUNGAL CLOTRIMAZOLE CREAM TOPICAL 20120401 OTC MONOGRAPH FINAL part333C FAMILY DOLLAR CLOTRIMAZOLE 1 g/100g E 20171231 55319-455_923a23e2-be11-4586-b623-7e7d298afa14 55319-455 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl TABLET, FILM COATED ORAL 20050628 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 55319-457_d26de0b5-5676-4401-b17c-178bf1860da8 55319-457 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20150131 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN 500 mg/1 N 20181231 55319-466_3375639c-8e0a-40bc-93ed-ae28a1455cfa 55319-466 HUMAN OTC DRUG Sinus Congestion and Pain Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55319-468_03c9ce58-1945-43e6-9050-79b6973e6053 55319-468 HUMAN OTC DRUG Non-Drowsy Daytime Multi Symptom Cold and Flu Relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20151031 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55319-470_d20d68f3-d6c7-498b-b406-09102ae3dfd6 55319-470 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130630 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55319-472_65900198-7e8e-41c4-95ce-5434fc57b0a2 55319-472 HUMAN OTC DRUG Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20160331 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) N 20181231 55319-475_5bf27c89-9d4d-4687-a829-074081c330ee 55319-475 HUMAN OTC DRUG Family Wellness childrens All Day Allergy Cetirizine HCl SOLUTION ORAL 20151031 ANDA ANDA204226 Family Dollar Services Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 55319-480_adbad346-8198-488c-bac9-e44f3954e799 55319-480 HUMAN OTC DRUG Nighttime Cold and Flu Relief Multi-Symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130630 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 55319-481_9b54a827-d40a-4c61-a356-a48c471bbc53 55319-481 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 20160630 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55319-486_0612c5b5-6019-48b2-aa29-0da0fdab7e1e 55319-486 HUMAN OTC DRUG Natural Vegetable Laxative Sennosides TABLET ORAL 20151031 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) SENNOSIDES 8.6 mg/1 N 20181231 55319-487_9f6b1e10-7504-4bdd-a06f-5f89f56f4d17 55319-487 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20160229 OTC MONOGRAPH FINAL part347 Family Dollar (FAMILY WELLNESS) DIMETHICONE 125 mg/1 N 20191231 55319-490_d4cd066b-7c61-4b1e-b026-30a4988d6ceb 55319-490 HUMAN OTC DRUG Daytime Nighttime Cold and Flu Relief Multi-Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130630 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) N 20181231 55319-491_614aacb1-b7bf-4648-95c7-bddf8fc2e823 55319-491 HUMAN OTC DRUG Pain Reliever Acetaminophen TABLET ORAL 20171231 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN 325 mg/1 N 20191231 55319-492_d8c8096e-c184-4cd0-b534-26523cdeb860 55319-492 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ASPIRIN 325 mg/1 N 20181231 55319-494_0727412f-12e8-4141-b83c-9fb0fd742404 55319-494 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20160331 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN 500 mg/1 N 20181231 55319-499_35fefca8-5283-453f-b6f0-1bbf15ab2d01 55319-499 HUMAN OTC DRUG Night Time Cough Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20171231 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20191231 55319-500_65c21404-f2c7-4f65-9bad-6b08107fce53 55319-500 HUMAN OTC DRUG Waterless Lavender Scented Hand Sanitizer ALCOHOL GEL TOPICAL 20110328 OTC MONOGRAPH FINAL part333E Family Dollar Services Inc. ALCOHOL 63 mL/100mL E 20171231 55319-501_592786a5-6cc6-4a6a-9c33-f16e72f3a652 55319-501 HUMAN OTC DRUG Waterless Fragrance Free Hand Sanitizer ALCOHOL GEL TOPICAL 20110328 OTC MONOGRAPH FINAL part333E Family Dollar Services Inc. ALCOHOL 63 mL/100mL E 20171231 55319-502_2d791fee-0635-4430-96d5-e0c1add591de 55319-502 HUMAN OTC DRUG Waterless Aloe Scented Hand Sanitizer ALCOHOL GEL TOPICAL 20110328 OTC MONOGRAPH FINAL part333E Family Dollar Services Inc. ALCOHOL 63 mL/100mL E 20171231 55319-503_61441b35-d0dd-8a99-e053-2991aa0a0de0 55319-503 HUMAN OTC DRUG Hand Sanitizer with Moisturizers and Vitamin E Alcohol GEL TOPICAL 20120831 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. ALCOHOL 70 mL/100mL N 20181231 55319-504_f6a4de8d-ec61-4088-961a-962675b91c37 55319-504 HUMAN OTC DRUG Hand Sanitizer with Moisturizers and Vitamin E Alcohol LIQUID TOPICAL 20120831 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. ALCOHOL 70 mL/100mL E 20171231 55319-505_9584a7b4-3551-4f12-a0c7-337bb1b6a9c9 55319-505 HUMAN OTC DRUG Hand Sanitizer with Moisturizers and Vitamin E Alcohol LIQUID TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. ALCOHOL 65 mL/100mL E 20171231 55319-506_f039ce6a-de7e-4404-bf9b-ab94850d66c3 55319-506 HUMAN OTC DRUG Family Dollar Oil Free Acne Wash Salicylic Acid LIQUID TOPICAL 20140113 OTC MONOGRAPH FINAL part333D Family Dollar Services Inc. SALICYLIC ACID 2 g/100mL N 20181231 55319-507_2caa895d-ab10-4793-990c-3c34065763b7 55319-507 HUMAN OTC DRUG Cold Relief Multi-Symptom, Daytime, Nighttime, Non-drowsy Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl KIT 20050804 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc N 20181231 55319-510_9edd241e-cb90-43fd-85ef-4612bc13aafa 55319-510 HUMAN OTC DRUG Family Dollar Instant Hand Sanitizer with Moisturizers and Vitamin E Alcohol GEL TOPICAL 20131023 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. ALCOHOL 70 mL/100mL N 20181231 55319-512_586338d7-7c8a-4305-bca3-fd83b7c8374d 55319-512 HUMAN OTC DRUG Family Dollar Antibacterial Hand Triclosan SOAP TOPICAL 20140102 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc. TRICLOSAN .15 g/100mL N 20181231 55319-519_f2c8ff7e-1622-4fac-b83b-f666b17c7eb7 55319-519 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ACETAMINOPHEN 500 mg/1 N 20181231 55319-525_dfa4733a-9b6b-4fe8-bec2-96078cd01027 55319-525 HUMAN OTC DRUG Anti-Itch Extra Strength diphenhydramine hydrochloride and zinc acetate CREAM TOPICAL 20091207 OTC MONOGRAPH NOT FINAL part348 Family Dollar Services Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g E 20171231 55319-526_a6858dab-fe54-4a85-9321-4ea7d6e022c9 55319-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Family Dollar Services, Inc. LORATADINE 10 mg/1 N 20181231 55319-529_a0e91f99-d39e-410d-ba73-457a0e6ddf89 55319-529 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpehniramine HCl, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 20200810 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc N 20181231 55319-531_97782d42-2860-4a7a-aca3-e724b6c391f3 55319-531 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ACETAMINOPHEN 500 mg/1 N 20181231 55319-532_31b4e828-c83f-4c91-bea4-05e96ef7c835 55319-532 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, FILM COATED ORAL 20051222 20190708 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc GUAIFENESIN 400 mg/1 E 20171231 55319-533_4bdbe97c-7850-41bf-982c-f3a4b2423c2c 55319-533 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr and Guaifenesin TABLET, FILM COATED ORAL 20051231 20190708 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 E 20171231 55319-534_c0760191-aa43-4a30-b1c2-f8d45339a57b 55319-534 HUMAN OTC DRUG Non-Drowsy Daytime Multi-Symptom Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070919 20180727 OTC MONOGRAPH FINAL part341 Family Dollar ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 55319-535_05693bf0-5839-4ba2-9ea0-5b8bc4fa13a1 55319-535 HUMAN OTC DRUG Nighttime Multi-Symptom Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20070910 20180727 OTC MONOGRAPH FINAL part341 Family Dollar ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 E 20171231 55319-540_7e462a40-21e9-4ab0-9140-17ed51266e6f 55319-540 HUMAN OTC DRUG Childrens Pain Reliever Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ACETAMINOPHEN 160 mg/1 N 20191231 55319-554_a475a511-e0ef-4fd3-a87a-f9d1fee81086 55319-554 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Family Dollar Services, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 55319-556_380ca7d2-5196-4996-b92a-0998f8fa9367 55319-556 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55319-568_ba367975-f385-4697-8f5d-2a7b6ee5f6fa 55319-568 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20170630 ANDA ANDA079174 Family Dollar (FAMILY WELLNESS) IBUPROFEN 200 mg/1 N 20181231 55319-578_eb0c943a-51ee-40ca-99bc-8ae27fa77530 55319-578 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170630 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) DOCUSATE SODIUM 100 mg/1 N 20181231 55319-590_dbc0c9d7-a597-46f8-a0fd-4c5fea995bb7 55319-590 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20171231 OTC MONOGRAPH FINAL part347 Family Dollar (FAMILY WELLNESS) WITCH HAZEL 842 mg/mL N 20191231 55319-596_72e5b222-0a11-4736-82d1-7a9fc2977a16 55319-596 HUMAN OTC DRUG Childrens Chewable Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20110407 OTC MONOGRAPH FINAL part331 Family Dollar Services Inc CALCIUM CARBONATE 400 mg/1 N 20181231 55319-600_6771cc17-b510-4c8b-aeb8-78acd5dee1ed 55319-600 HUMAN OTC DRUG Safety Coated Low Dose Aspirin Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ASPIRIN 81 mg/1 N 20181231 55319-612_e219d5a2-6561-43cc-8fe8-52a00b13fa3e 55319-612 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20121218 OTC MONOGRAPH FINAL part358H Family Dollar Services, Inc. PYRITHIONE ZINC 1 g/mL N 20181231 55319-616_3cb8cdd7-97d9-45df-bde9-44d6d7c70867 55319-616 HUMAN OTC DRUG Multi-Symptom Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55319-619_e6eef12a-c574-44b8-9389-7eabff0ca79e 55319-619 HUMAN OTC DRUG Regular Strength Acid Reducer Ranitidine TABLET ORAL 20130615 20180715 ANDA ANDA200536 Family Dollar RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 55319-620_19e955e3-b3ef-458b-9ff8-599476222472 55319-620 HUMAN OTC DRUG Acid Reducer Maximum Strength Ranitidine TABLET, FILM COATED ORAL 20130615 20180715 ANDA ANDA200536 Family Dollar RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 55319-624_5e996df3-25a5-b259-e053-2a91aa0a4311 55319-624 HUMAN OTC DRUG SUPREME ANTACID calcium carbonate, magnesium hydroxide SUSPENSION ORAL 20170601 OTC MONOGRAPH FINAL part331 FAMILY DOLLAR SERVICES INC CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 400; 135 mg/5mL; mg/5mL N 20181231 55319-625_da6e8c41-7b05-4560-bf99-7513c29113bb 55319-625 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20160831 OTC MONOGRAPH NOT FINAL part343 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20191231 55319-626_1185354e-5458-4ebc-93f2-1b6ac9032956 55319-626 HUMAN OTC DRUG Family Wellness Antifungal Clotrimazole CREAM TOPICAL 20140121 OTC MONOGRAPH FINAL part333C Family Dollar CLOTRIMAZOLE 10 mg/g N 20181231 55319-629_5ea9305b-299a-49d3-e053-2991aa0a1fa1 55319-629 HUMAN OTC DRUG REGULAR STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20170601 OTC MONOGRAPH FINAL part331 FAMILY DOLLAR SERVICES INC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 55319-634_4b2ee5aa-5228-4bc2-b6f0-14779675204e 55319-634 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20170630 OTC MONOGRAPH NOT FINAL part334 Family Dollar (FAMILY WELLNESS) MINERAL OIL 100 mg/100mL N 20181231 55319-638_8c202959-98aa-4c10-9bbf-f91215f59e5e 55319-638 HUMAN OTC DRUG Family Wellness Antifungal Tolnaftate CREAM TOPICAL 20140121 OTC MONOGRAPH FINAL part333C Family Dollar TOLNAFTATE 1 g/100g N 20181231 55319-647_5ea9305b-2998-49d3-e053-2991aa0a1fa1 55319-647 HUMAN OTC DRUG MILK OF MAGNESIA magnesium hydroxide SUSPENSION ORAL 20170601 OTC MONOGRAPH NOT FINAL part334 FAMILY DOLLAR SERVICES INC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 55319-648_5ea9238a-ab02-06bf-e053-2a91aa0abec6 55319-648 HUMAN OTC DRUG MILK OF MAGNESIA magnesium hydroxide SUSPENSION ORAL 20170601 OTC MONOGRAPH NOT FINAL part334 FAMILY DOLLAR SERVICES INC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 55319-659_e1365e1a-0b5b-418d-bfd0-983bb06110c0 55319-659 HUMAN OTC DRUG Cold and Flu Relief Daytime Multi Symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 20191219 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55319-660_26b2ec55-1ac9-4ea6-9f67-29b59b5f5f19 55319-660 HUMAN OTC DRUG Cold and Flu Relief Nighttime, Multi-Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20150301 20190922 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 55319-661_89e2ebed-5903-4f46-b465-bda41c6f6aaf 55319-661 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20171005 ANDA ANDA079174 Family Dollar (FAMILY WELLNESS) IBUPROFEN 200 mg/1 N 20181231 55319-664_dfa219c0-465e-4751-8209-a66cfaf84c0b 55319-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20110111 OTC MONOGRAPH NOT FINAL part356 Family Dollar Services, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55319-676_3d1ef344-5dc9-4227-aa05-8319a6c92ef9 55319-676 HUMAN OTC DRUG Laxative for Women Bisacodyl TABLET ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 Family Dollar Services Inc BISACODYL 5 mg/1 N 20181231 55319-679_8a563ff1-9a92-47f4-b231-884add4a08cd 55319-679 HUMAN OTC DRUG Menstrual Pain Relief Maximum Strength Acetaminophen, Pamabrom, Pyrilamine maleate TABLET, FILM COATED ORAL 20150113 OTC MONOGRAPH NOT FINAL part343 Family Dollar Services Inc ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 55319-689_667dc8bb-dcd9-4412-b7d2-246312b3d713 55319-689 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr TABLET, COATED ORAL 20170331 OTC MONOGRAPH FINAL part341 Family Dollar Services Inc CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 55319-700_62265132-00b8-43fa-964b-1c8396f7e851 55319-700 HUMAN OTC DRUG First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20171213 OTC MONOGRAPH NOT FINAL part333E Family Dollar Services POVIDONE-IODINE 10 mg/mL N 20191231 55319-704_e3c94062-fa41-4744-9282-1ac0b9a86f68 55319-704 HUMAN OTC DRUG Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20171201 OTC MONOGRAPH FINAL part352 Family Dollar Services Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 72.1; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; 1/mL N 20181231 55319-727_e6212c36-5f0c-4bd0-8ccb-c248364c9f8c 55319-727 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Family Dollar Services, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 26.49; 132.45; 44.15; 52.98 mg/g; mg/g; mg/g; mg/g N 20181231 55319-730_bb521c20-8235-41c0-a533-8cb234e5c525 55319-730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20060606 ANDA ANDA074164 Family Dollar Services Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 55319-752_411270fd-18f1-4f65-8eec-e4473e6974f9 55319-752 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Family Dollar Services, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 72.1; 41.2 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 55319-764_33627902-30cd-4bd2-9999-ca26122428ff 55319-764 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160112 OTC MONOGRAPH FINAL part352 Family Dollar Services, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.6; 119; 45.9; 45.9; 55.08 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55319-771_14c4218d-39e0-4ace-bbe6-a043088d6591 55319-771 HUMAN OTC DRUG Nighttime Multi Symptom Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20150831 OTC MONOGRAPH FINAL part341 Family Dollar (FAMILY WELLNESS) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 55319-787_3322da8d-c0b0-4a18-a59d-1f9fbb832727 55319-787 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Family Dollar Services, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 26.49; 132.45; 44.15; 52.98 mg/g; mg/g; mg/g; mg/g N 20181231 55319-788_2b995664-8953-4f9b-bed2-17fa03b39705 55319-788 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Family Dollar Services, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27.03; 135.15; 45.05; 90.1; 54.06 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 55319-789_49eb3c0e-b3bd-4a51-8e57-bb5eb0996a28 55319-789 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Family Dollar Services, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.07; 86.9; 43.45; 34.76; 43.45 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 55319-790_427bf4ae-4ceb-4650-9c6c-283f1bb6701c 55319-790 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 Family Dollar Services, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.95; 86.5; 43.25; 17.3; 34.6 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 55319-800_b2fcb2b8-a5f4-4d98-87d5-7a436b494800 55319-800 HUMAN OTC DRUG Sleep Aid NightTime Diphenhydramine HCL TABLET ORAL 20160731 OTC MONOGRAPH FINAL part338 Family Dollar (FAMILY WELLNESS) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55319-805_5626b091-de48-4fd9-8bc7-fa8a0c88a4ed 55319-805 HUMAN OTC DRUG Family Wellness Sterile Alcohol Isopropyl Alcohol SWAB TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services Inc ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 55319-810_4435815a-edcd-454b-8729-349d775680f9 55319-810 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20171211 OTC MONOGRAPH NOT FINAL part333A FAMILY DOLLAR SERVICES, INC ISOPROPYL ALCOHOL .7 mg/mL N 20181231 55319-852_398cc88c-5154-4e16-b908-7e4144b17b29 55319-852 HUMAN OTC DRUG Family Wellness Acid Reducer 150 Ranitidine TABLET, FILM COATED ORAL 20170427 ANDA ANDA091429 Family Dollar Services Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 55319-864_3119e081-0fd7-4697-b38f-edd6115e2f1a 55319-864 HUMAN OTC DRUG 50% Rubbing Isopropyl Alcohol LIQUID TOPICAL 20160614 OTC MONOGRAPH NOT FINAL part333A Family Dollar Services, Inc ISOPROPYL ALCOHOL 500 mg/mL N 20181231 55319-866_6133fdc3-723a-426c-9484-4ba591bdb10a 55319-866 HUMAN OTC DRUG family wellness lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20121205 OTC MONOGRAPH FINAL part358G Family Dollar Services Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 55319-871_5f8f8b76-8838-4a7f-8249-08bade6e4e48 55319-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A Family Dollar HYDROGEN PEROXIDE 30 mg/mL N 20181231 55319-873_5ddf2b1b-62f0-e06b-e053-2991aa0a32a7 55319-873 HUMAN OTC DRUG Family Wellness Effervescent Cold Relief Original Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20110915 OTC MONOGRAPH FINAL part341 Family Dollar Services, Inc. PHENYLEPHRINE BITARTRATE; ASPIRIN; CHLORPHENIRAMINE MALEATE 7.8; 325; 2 mg/1; mg/1; mg/1 N 20181231 55319-875_5de36266-3952-5aca-e053-2991aa0a2205 55319-875 HUMAN OTC DRUG Family Wellness Effervescent Cold Relief Orange Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20110915 OTC MONOGRAPH FINAL part341 Family Dollar Services, Inc. PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE; ASPIRIN 7.8; 2; 325 mg/1; mg/1; mg/1 N 20181231 55319-876_15db6e80-cd90-4496-8b8f-a1e1791d7443 55319-876 HUMAN OTC DRUG Family Wellness acid reducer Ranitidine TABLET, COATED ORAL 20170607 ANDA ANDA076195 Family Dollar Services Inc RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 55319-897_87655c3a-5894-4c2e-9fc6-91b15a777db1 55319-897 HUMAN OTC DRUG family wellness childrens ibuprofen Ibuprofen SUSPENSION ORAL 20020822 ANDA ANDA074937 Family Dollar Services Inc IBUPROFEN 100 mg/5mL N 20181231 55319-898_f37083d2-9f89-432d-b946-f1ff197ca847 55319-898 HUMAN OTC DRUG Family Wellness Esomeprazole Magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20171005 ANDA ANDA207193 Family Dollar Services Inc ESOMEPRAZOLE 20 mg/1 N 20181231 55319-900_f06fee99-2d1b-4adf-a5a0-9e90db64a461 55319-900 HUMAN OTC DRUG Family Wellness Sensitive Extra Whitening Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20130411 OTC MONOGRAPH NOT FINAL part356 Family Wellness POTASSIUM NITRATE; SODIUM FLUORIDE 5; 1.5 mg/g; mg/g E 20171231 55319-915_7d6547cb-a44a-4a73-b4f5-5129d3910557 55319-915 HUMAN OTC DRUG Family Wellness Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20130814 NDA NDA022032 Family Dollar Services Inc OMEPRAZOLE 20 mg/1 N 20181231 55319-916_617d30f5-c388-dc04-a409-d38d05e0c8dc 55319-916 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20120810 ANDA ANDA078878 Family Dollar Stores, Inc. OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 55319-917_f45f4a1e-a3ea-afbc-c9a9-3c3df8da0a29 55319-917 HUMAN OTC DRUG Allergy Relief Fexofenadine hydrochloride TABLET ORAL 20120412 ANDA ANDA076502 Family Dollar Stores, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 55319-928_e55e3643-b2d3-474b-a5c4-6accb0a19725 55319-928 HUMAN OTC DRUG Nighttime Cold Max acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride LIQUID ORAL 20160629 OTC MONOGRAPH FINAL part341 Family Dollar, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 55319-939_65ed577d-07a6-40e5-bff5-26b9ec806f04 55319-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20170901 ANDA ANDA077498 FAMILY DOLLAR SERVICES, INC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20191231 55319-941_83ccca19-7684-4fcd-a645-94cebdbc9860 55319-941 HUMAN OTC DRUG Clear Anti-Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 20151216 OTC MONOGRAPH NOT FINAL part347 Family Dollar Services, Inc., PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 1; .1 mg/mL; mg/mL N 20181231 55319-950_60e2fd68-9069-db6a-e053-2a91aa0acb70 55319-950 HUMAN OTC DRUG Family Dollar Antibacterial Hand BENZETHONIUM CHLORIDE SOAP TOPICAL 20170114 OTC MONOGRAPH NOT FINAL part333E Family Dollar Services, Inc BENZETHONIUM CHLORIDE 1 mg/mL N 20181231 55319-952_f10769fe-6502-4186-a80c-b15be66c4320 55319-952 HUMAN OTC DRUG Advanced Healing Petrolatum OINTMENT TOPICAL 20150715 OTC MONOGRAPH FINAL part347 Family Dollar Services INC PETROLATUM 340 mg/g N 20181231 55319-972_67f88420-9916-419a-832b-de225693a952 55319-972 HUMAN OTC DRUG Antiseptic Rinse Spring Mint Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20140512 OTC MONOGRAPH NOT FINAL part356 Family Dollar EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55319-976_64f6c465-30bf-4837-a905-e804c587fcd4 55319-976 HUMAN OTC DRUG DAY TIME SEVERE COLD AND COUGH acetaminophen, dextromethorphan hbr and phenylephrine hcl SYRUP ORAL 20160609 OTC MONOGRAPH FINAL part341 Family Dollar, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55319-977_3341742b-4cec-4ba4-8bf2-2f4ba1b8fd2f 55319-977 HUMAN OTC DRUG Night Time Severe Cold and Cough Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl SYRUP ORAL 20160609 OTC MONOGRAPH FINAL part341 Family Dollar, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55319-987_971395f1-f797-49a3-afa9-fe42725508db 55319-987 HUMAN OTC DRUG Mucus Relief DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Family Dollar, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 55319-988_49a246ad-7234-42f0-94d5-2d0ab9db8c7f 55319-988 HUMAN OTC DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20171016 ANDA ANDA209339 Family Dollar, Inc. ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg/1 N 20181231 55319-993_dc21a3ee-7912-4b38-bbb7-67262a615bcf 55319-993 HUMAN OTC DRUG Severe Cold and Mucus acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, guaifenesin LIQUID ORAL 20160609 OTC MONOGRAPH FINAL part341 Family Dollar, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 55319-994_10ce7f5d-2184-4580-b94e-d37fda28b8d1 55319-994 HUMAN OTC DRUG Childrens Cold and Allergy Brompheniramine maleate and Phenylephrine HCl SOLUTION ORAL 20160610 OTC MONOGRAPH FINAL part341 Family Dollar, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL N 20181231 55319-997_7dc0548c-f500-4ff2-9e0a-7592caf4a907 55319-997 HUMAN OTC DRUG Extra Strength Pain Reliever Fever Reducer acetaminophen LIQUID ORAL 20151008 OTC MONOGRAPH NOT FINAL part343 Family Dollar, Inc. ACETAMINOPHEN 500 mg/15mL N 20181231 55319-998_f8469b96-80f4-4292-9950-f4b2e63fb387 55319-998 HUMAN OTC DRUG Pain Relief PM acetaminophen, diphenhydramine hydrochloride LIQUID ORAL 20150623 OTC MONOGRAPH NOT FINAL part343 Family Dollar, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/15mL; mg/15mL N 20181231 55319-999_08914eb5-3441-4718-a232-50164fd915f4 55319-999 HUMAN OTC DRUG Multi-Symptom Menstrual Pain Relief Acetaminophen, Pamabrom and Pyrilamine maleate TABLET, FILM COATED ORAL 20000620 20190119 OTC MONOGRAPH NOT FINAL part343 Family Dollar ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 E 20171231 55322-0001_afa9f1e2-c643-4ac6-bfbf-8384798c512c 55322-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850601 UNAPPROVED MEDICAL GAS Diamond Drugs Inc. dba Diamond Medical Supply OXYGEN 99 L/100L E 20171231 55328-900_e33f4418-bf2e-47b9-835e-8bbe25fe2744 55328-900 HUMAN OTC DRUG Salonpas DEEP Relieving Camphor, Menthol, Methyl salicylate GEL PERCUTANEOUS; TOPICAL; TRANSDERMAL 20130601 OTC MONOGRAPH NOT FINAL part348 Hisamitsu America, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 10; 15 g/100g; g/100g; g/100g N 20181231 55328-901_bf222b64-e101-4473-aae8-3e7df1a531e7 55328-901 HUMAN OTC DRUG Salonpas LIDOCAINE PLUS Benzyl alcohol, Lidocaine hydrochloride LIQUID PERCUTANEOUS; TOPICAL; TRANSDERMAL 20170901 OTC MONOGRAPH NOT FINAL part348 Hisamitsu America, Inc. BENZYL ALCOHOL; LIDOCAINE HYDROCHLORIDE 10; 4 g/100g; g/100g N 20181231 55328-902_97fdd9f0-4f1f-4fd4-a83a-96666e7b812b 55328-902 HUMAN OTC DRUG Salonpas LIDOCAINE PLUS Benzyl alcohol, Lidocaine hydrochloride CREAM PERCUTANEOUS; TOPICAL; TRANSDERMAL 20170623 OTC MONOGRAPH NOT FINAL part348 Hisamitsu America, Inc. BENZYL ALCOHOL; LIDOCAINE HYDROCHLORIDE 10; 4 g/100g; g/100g N 20181231 55330-0001_d975cbea-c0f0-42c3-bd45-67a9ed3ab8bf 55330-0001 HUMAN OTC DRUG Wholistic Thyroid Balance Fucus Vesiculosus, Thyroidinum (Suis), Spongia Tosta LIQUID ORAL 20130820 UNAPPROVED HOMEOPATHIC Institute for Wholistic Rejuvenation FUCUS VESICULOSUS; SUS SCROFA THYROID; SPONGIA OFFICINALIS SKELETON, ROASTED 3; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55346-0401_5fae01f6-6ad3-2875-e053-2a91aa0ae432 55346-0401 HUMAN OTC DRUG Home Care Fluoride Stannous Fluoride GEL DENTAL; ORAL 19991231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g N 20181231 55346-0402_5fae033c-e8f4-130f-e053-2a91aa0ad415 55346-0402 HUMAN OTC DRUG Alpha-dent Home Care Fluoride Stannous Fluoride GEL DENTAL; ORAL 19991231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g N 20181231 55346-0404_5fae3e77-098b-2530-e053-2991aa0af8fe 55346-0404 HUMAN OTC DRUG Home Care Fluoride Stannous Fluoride GEL DENTAL; ORAL 19991231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g N 20181231 55346-0408_5faddf54-ffc0-d97d-e053-2991aa0a02b0 55346-0408 HUMAN OTC DRUG Home Care Fluoride Stannous Fluoride GEL DENTAL; ORAL 19991231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g N 20181231 55346-0411_210c7778-9a73-4de2-e054-00144ff88e88 55346-0411 HUMAN OTC DRUG Plak Smacker Stannous Fluoride GEL DENTAL; ORAL 20071231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g E 20171231 55346-0412_210c7778-9a64-4de2-e054-00144ff88e88 55346-0412 HUMAN OTC DRUG Plak Smacker Stannous Fluoride GEL DENTAL; ORAL 20071231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g E 20171231 55346-0414_210c8016-397a-2c75-e054-00144ff8d46c 55346-0414 HUMAN OTC DRUG Plak Smacker Stannous Fluoride GEL DENTAL; ORAL 20071231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g E 20171231 55346-0418_210c6251-660e-5b6a-e054-00144ff88e88 55346-0418 HUMAN OTC DRUG Plak Smacker Stannous Fluoride GEL DENTAL; ORAL 20071231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g E 20171231 55346-0431_210c6251-6601-5b6a-e054-00144ff88e88 55346-0431 HUMAN OTC DRUG Plak Smacker Stannous Fluoride GEL DENTAL; ORAL 20071231 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc. STANNOUS FLUORIDE .969 mg/g E 20171231 55346-0718_605132f8-920f-6e5f-e053-2991aa0a71b2 55346-0718 HUMAN OTC DRUG Plak Smacker Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20071231 20191031 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc SODIUM FLUORIDE 2.4 mg/g N 20181231 55346-0719_605132f8-9204-6e5f-e053-2991aa0a71b2 55346-0719 HUMAN OTC DRUG Plak Smacker Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20071231 20180331 OTC MONOGRAPH FINAL part355 Dental Technologies, Inc SODIUM FLUORIDE .4 mg/g N 20181231 55346-0942_60132265-446f-7e66-e053-2991aa0a8237 55346-0942 HUMAN PRESCRIPTION DRUG Alpha-Pro Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20130401 UNAPPROVED DRUG OTHER Dental Technologies, Inc. SODIUM FLUORIDE; HYDROFLUORIC ACID 7.9; 4.4 mg/g; mg/g N 20181231 55346-0943_6013b56c-c1f3-7949-e053-2991aa0a9887 55346-0943 HUMAN PRESCRIPTION DRUG Alpha-Pro Sodium Fluoride and Hydrofluoric Acid GEL DENTAL 20130401 UNAPPROVED DRUG OTHER Dental Technologies, Inc. SODIUM FLUORIDE; HYDROFLUORIC ACID 7.9; 4.4 mg/g; mg/g N 20181231 55346-1401_74537324-55c2-4912-94ab-a345658f7aa5 55346-1401 HUMAN OTC DRUG Comfortcaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g E 20171231 55346-1402_3a29ef01-a52f-4298-9e37-bc3b7c7f3a63 55346-1402 HUMAN OTC DRUG ComfortCaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g E 20171231 55346-1403_b56810f2-801b-4f93-94a3-976cfb94be44 55346-1403 HUMAN OTC DRUG ComfortCaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g E 20171231 55346-1404_24d87084-a853-4fe3-88ff-a1777276bd46 55346-1404 HUMAN OTC DRUG Comfortcaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g E 20171231 55346-1405_0b2689c1-a87e-4d25-aeed-db81a539fd6e 55346-1405 HUMAN OTC DRUG ComfortCaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g E 20171231 55346-1406_9594ff9b-78e3-4dd0-b8d2-204be31e63a0 55346-1406 HUMAN OTC DRUG Comfortcaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Dental Technologies, Inc. BENZOCAINE 200 mg/g E 20171231 55379-404_ac502553-75ab-458f-8130-9b6013c2004c 55379-404 HUMAN OTC DRUG Joint and Muscle Pain Menthol CREAM TOPICAL 20090715 OTC MONOGRAPH NOT FINAL part348 BioZone Laboratories, Inc. MENTHOL 50 mg/g N 20181231 55379-405_4e2e9bc4-6ba8-11e0-ae3e-0800200c9a66 55379-405 HUMAN PRESCRIPTION DRUG Hybrisil Methylprednisolone Acetate GEL TOPICAL 20100505 UNAPPROVED DRUG OTHER BioZone Laboratories, Inc. METHYLPREDNISOLONE ACETATE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 55379-406_008a5dc6-136b-4809-bec6-0a7ecf1f3981 55379-406 HUMAN OTC DRUG CortiSil MDX HYDROCORTISONE ACETATE GEL TOPICAL 20130325 OTC MONOGRAPH FINAL part348 BioZone Laboratories,Inc. HYDROCORTISONE ACETATE 1 g/100g N 20181231 55379-407_f050e1de-72f4-41b2-b8c7-c6e3caf441da 55379-407 HUMAN OTC DRUG A AND A Diaper Rash cream DIMETHICONE and ZINC OXIDE CREAM TOPICAL 20130615 OTC MONOGRAPH FINAL part347 BioZone Laboratories, Inc. DIMETHICONE; ZINC OXIDE 10; 100 mg/g; mg/g N 20181231 55390-308_5c68e9e1-47b8-4c03-8f8a-60afc67e023e 55390-308 HUMAN PRESCRIPTION DRUG amifostine amifostine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080402 20181231 NDA NDA020221 Bedford Laboratories AMIFOSTINE 500 mg/10mL Cytoprotective Agent [EPC],Free Radical Scavenging Activity [MoA] N 20181231 55390-370_57820857-4427-9067-a130-4e1a6ca3e637 55390-370 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride Topotecan Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110418 ANDA ANDA201191 Bedford Laboratories TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 55390-391_4cef5f77-82b5-ba03-1f26-4fdeb8af63fd 55390-391 HUMAN PRESCRIPTION DRUG gemcitabine gemcitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120319 ANDA ANDA091365 Bedford Laboratories GEMCITABINE HYDROCHLORIDE 40 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 55404-001_60f6932f-371f-fbbe-e053-2a91aa0af167 55404-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19640101 NDA NDA205767 Lessors, Incorporated OXYGEN 995 mL/L N 20191231 55404-002_60f678d0-28a5-d982-e053-2a91aa0a794c 55404-002 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19640101 NDA NDA209989 Lessors, Incorporated NITROUS OXIDE 990 mL/L N 20191231 55413-2500_a24246b3-9b69-4969-b06c-7068623d7c1f 55413-2500 HUMAN OTC DRUG Raw Ice menthol LIQUID TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part348 Raw Health International, LLC MENTHOL 34.79 g/L N 20181231 55413-2501_d851dba4-b008-4343-a4ea-66dd8a981177 55413-2501 HUMAN OTC DRUG Raw Heat menthol LIQUID TOPICAL 20130115 OTC MONOGRAPH NOT FINAL part348 Raw Health International, LLC MENTHOL 34.86 g/L N 20181231 55424-1238_149068a8-1b23-4530-8a0f-a65f98ad5da5 55424-1238 HUMAN OTC DRUG Nan San MUSFLEX External Analgesic CAMPHOR (NATURAL), MENTHOL LOTION TOPICAL 20130109 OTC MONOGRAPH FINAL part348 CHUNG KEE USA INTERNATIONAL INC CAMPHOR (NATURAL); MENTHOL 60; 160 mg/mL; mg/mL E 20171231 55424-1398_191734b3-f360-4e02-9211-52c127c94788 55424-1398 HUMAN OTC DRUG Pain Relieving MUSFLEX CAMPHOR (NATURAL), MENTHOL LOTION TOPICAL 20130109 OTC MONOGRAPH FINAL part348 CHUNG KEE USA INTERNATIONAL INC CAMPHOR (NATURAL); MENTHOL 56; 56 mg/mL; mg/mL N 20181231 55429-0838_f11d9187-e135-468f-b8f1-0bb7d32536b1 55429-0838 HUMAN OTC DRUG Nan San EASY FLEX Pain Relieving MENTHOL LOTION TOPICAL 20140611 OTC MONOGRAPH NOT FINAL part348 Herba Enterprise Inc MENTHOL 60 mg/mL N 20181231 55439-000_674d70e4-8be1-4f0f-bc01-4a41b8e36dde 55439-000 HUMAN OTC DRUG Royal Hand Sanitizer ALCOHOL GEL TOPICAL 20130107 OTC MONOGRAPH NOT FINAL part333E GPM Investments LLC ALCOHOL 620 mg/mL E 20171231 55441-201_61956c46-fdac-ce9d-e053-2991aa0af1fb 55441-201 HUMAN OTC DRUG Medi-Clean Antiseptic Hand Cleaner CHLOROXYLENOL LIQUID TOPICAL 20120213 OTC MONOGRAPH NOT FINAL part333E Formula Corp. CHLOROXYLENOL 6 mg/mL N 20191231 55441-901_ebe14342-2397-431f-b79f-6680b7038d71 55441-901 HUMAN OTC DRUG ecologique PYRITHIONE ZINC SHAMPOO TOPICAL 20120213 OTC MONOGRAPH FINAL part358H Formula Corp. PYRITHIONE ZINC 1 mL/100mL N 20181231 55443-0085_0f3d5deb-cd79-499f-93aa-9fe990277a79 55443-0085 HUMAN OTC DRUG VioNex Chloroxylenol GEL TOPICAL 19920101 OTC MONOGRAPH NOT FINAL part333 Metrex Research CHLOROXYLENOL .52 g/100mL E 20171231 55443-0090_8700e691-f8e2-4026-9d75-83eaaa378577 55443-0090 HUMAN OTC DRUG VioNex Chloroxylenol GEL TOPICAL 19920101 OTC MONOGRAPH NOT FINAL part333E Metrex Research CHLOROXYLENOL .52 g/100mL E 20171231 55443-0102_0c1487f9-c0e0-47ae-8969-282107b9a655 55443-0102 HUMAN OTC DRUG VioNex Towelette Chloroxylenol CLOTH TOPICAL 19920101 OTC MONOGRAPH NOT FINAL part333 Metrex Research CHLOROXYLENOL .5 g/100g E 20171231 55443-0200_2cdc122a-fe7b-4c0d-9ee7-dc38b25f6800 55443-0200 HUMAN OTC DRUG VioNexus Chloroxylenol LIQUID TOPICAL 19920101 OTC MONOGRAPH NOT FINAL part333E Metrex Research BENZALKONIUM CHLORIDE; ETHANOL .085; 77.01 g/100mL; g/100mL E 20171231 55465-001_39c34e36-fb4c-464b-9c23-2e3e777fa064 55465-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Ivey Industries Inc. OXYGEN 990 mL/L N 20181231 55465-002_71bf7684-affd-4a9b-8017-8c0a039b0007 55465-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19860801 UNAPPROVED MEDICAL GAS Ivey Industries NITROGEN 990 mL/L N 20181231 55466-104_632150d9-2222-775d-e053-2991aa0a4df4 55466-104 HUMAN PRESCRIPTION DRUG LEVO-T Levothyroxine Sodium TABLET ORAL 20151029 NDA NDA021342 Neolpharma, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 55466-105_632150d9-2222-775d-e053-2991aa0a4df4 55466-105 HUMAN PRESCRIPTION DRUG LEVO-T Levothyroxine Sodium TABLET ORAL 20151029 NDA NDA021342 Neolpharma, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 55466-106_632150d9-2222-775d-e053-2991aa0a4df4 55466-106 HUMAN PRESCRIPTION DRUG LEVO-T Levothyroxine Sodium TABLET ORAL 20151029 NDA NDA021342 Neolpharma, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 55466-107_632150d9-2222-775d-e053-2991aa0a4df4 55466-107 HUMAN PRESCRIPTION DRUG LEVO-T Levothyroxine Sodium TABLET ORAL 20151029 NDA NDA021342 Neolpharma, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 55466-108_632150d9-2222-775d-e053-2991aa0a4df4 55466-108 HUMAN PRESCRIPTION DRUG LEVO-T Levothyroxine Sodium TABLET ORAL 20151029 NDA NDA021342 Neolpharma, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 55466-109_632150d9-2222-775d-e053-2991aa0a4df4 55466-109 HUMAN PRESCRIPTION DRUG LEVO-T Levothyroxine Sodium TABLET ORAL 20151029 NDA NDA021342 Neolpharma, Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 55466-110_632150d9-2222-775d-e053-2991aa0a4df4 55466-110 HUMAN PRESCRIPTION DRUG LEVO-T Levothyroxine Sodium TABLET ORAL 20151029 NDA NDA021342 Neolpharma, Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 55466-111_632150d9-2222-775d-e053-2991aa0a4df4 55466-111 HUMAN PRESCRIPTION DRUG LEVO-T Levothyroxine Sodium TABLET ORAL 20151029 NDA NDA021342 Neolpharma, Inc. LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 55466-112_632150d9-2222-775d-e053-2991aa0a4df4 55466-112 HUMAN PRESCRIPTION DRUG LEVO-T Levothyroxine Sodium TABLET ORAL 20151029 NDA NDA021342 Neolpharma, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 55466-113_632150d9-2222-775d-e053-2991aa0a4df4 55466-113 HUMAN PRESCRIPTION DRUG LEVO-T Levothyroxine Sodium TABLET ORAL 20151029 NDA NDA021342 Neolpharma, Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 55466-114_632150d9-2222-775d-e053-2991aa0a4df4 55466-114 HUMAN PRESCRIPTION DRUG LEVO-T Levothyroxine Sodium TABLET ORAL 20151029 NDA NDA021342 Neolpharma, Inc. LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 55466-115_632150d9-2222-775d-e053-2991aa0a4df4 55466-115 HUMAN PRESCRIPTION DRUG LEVO-T Levothyroxine Sodium TABLET ORAL 20151029 NDA NDA021342 Neolpharma, Inc. LEVOTHYROXINE SODIUM 300 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 55494-100_6692e623-3422-45be-ae5d-2d897085a01a 55494-100 HUMAN PRESCRIPTION DRUG DICLEGIS doxylamine succinate and pyridoxine hydrochloride TABLET, DELAYED RELEASE ORAL 20130515 NDA NDA021876 Duchesnay USA, Inc. DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE 10; 10 mg/1; mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 55496-1001_d7961105-2315-4c0c-af10-02dd7e022ed8 55496-1001 HUMAN OTC DRUG Park no suk a clear walk of park ANGELICA ARCHANGELICA ROOT CREAM ORAL 20130216 UNAPPROVED DRUG OTHER Park No Suk a clear walk of park ANGELICA ARCHANGELICA ROOT 5 g/100g E 20171231 55502-1001_ae69f978-baed-4a37-b6aa-3eb54ce07dd0 55502-1001 HUMAN OTC DRUG B.S.C AMPUL ADENOSINE LIQUID TOPICAL 20130130 UNAPPROVED DRUG OTHER Cellcos Inc ADENOSINE .6 mg/6mL E 20171231 55504-0230_bba1749c-895b-4bea-8103-7a5c0dcc2296 55504-0230 HUMAN OTC DRUG DawnMist Antiperspirant and Deodorant ALUMINUM CHLOROHYDRATE SPRAY TOPICAL 20111005 OTC MONOGRAPH FINAL part350 Donovan Industries, Inc. ALUMINUM CHLOROHYDRATE 7.9 mL/100mL E 20171231 55504-0432_cd42069d-01be-4b52-90ae-0ad7a7fd0b30 55504-0432 HUMAN OTC DRUG DawnMist Hypoallergenic Petroleum PETROLATUM JELLY TOPICAL 20110927 OTC MONOGRAPH FINAL part347 Donovan Industries, Inc. PETROLATUM 100 g/100g E 20171231 55504-0540_60f08b51-e2cd-4939-9acb-401fd3a718ac 55504-0540 HUMAN OTC DRUG DawnMist Toothbrush, Toothpaste and Floss Kit PASTE DENTAL 20090901 OTC MONOGRAPH FINAL part355 Donovan Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/3g E 20171231 55504-3736_8b9abe45-9eb5-4888-bfb5-a584fe92af24 55504-3736 HUMAN OTC DRUG DawnMist Alcohol Gel Hand Sanitizer ALCOHOL GEL TOPICAL 20091106 OTC MONOGRAPH NOT FINAL part333 Donovan Industries, Inc. ALCOHOL 62 mL/100mL E 20171231 55504-3763_3b068719-aa3f-49ff-b858-e8d6a957d217 55504-3763 HUMAN OTC DRUG DawnMist Alcohol Gel Hand Sanitizer ALCOHOL GEL TOPICAL 20091106 OTC MONOGRAPH NOT FINAL part333 Donovan Industries, Inc. ALCOHOL 62 mL/100mL E 20171231 55504-4000_f901a748-4ab5-4aee-a87c-baf5b6f8c219 55504-4000 HUMAN OTC DRUG MediChoice Hand Sanitizer ALCOHOL GEL TOPICAL 20091231 OTC MONOGRAPH NOT FINAL part333 Donovan Industries, Inc. ALCOHOL 62 mL/100mL E 20171231 55504-4341_87b9b288-0dd8-4b02-90b2-bb09ab8838c6 55504-4341 HUMAN OTC DRUG dawnmist sodium fluoride PASTE DENTAL 20111101 OTC MONOGRAPH FINAL part355 Donavan SODIUM FLUORIDE 39.9 g/181.4g E 20171231 55504-9002_4d321671-c73c-4c0d-a20f-90eaf7fb6f94 55504-9002 HUMAN OTC DRUG DawnMist Unscented Roll-On Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20101001 OTC MONOGRAPH FINAL part350 Donovan Industries, Inc. ALUMINUM CHLOROHYDRATE 78 mg/100mL E 20171231 55505-103_8e1a8a49-72cd-4a36-b657-b52e2b8673fb 55505-103 HUMAN OTC DRUG Fungi Nail Toe and Foot Undecylenic acid LIQUID TOPICAL 20101207 OTC MONOGRAPH FINAL part333C Kramer Laboratories UNDECYLENIC ACID 250 mg/mL N 20181231 55505-111_e50218b5-aaed-4054-8227-3e0396365753 55505-111 HUMAN OTC DRUG Safetussin DM Dextromethorpan Guaifenesin LIQUID ORAL 20101129 OTC MONOGRAPH FINAL part341 Kramer Laboratories DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20191231 55505-167_43c1d6b2-37ad-4035-911b-5315d8dd11c2 55505-167 HUMAN OTC DRUG Fungi Nail Toe and Foot Pen Undecylenic acid LIQUID TOPICAL 20101205 OTC MONOGRAPH FINAL part333C Kramer Laboratories UNDECYLENIC ACID 250 mg/mL N 20181231 55505-173_57c7cfc0-2278-4a06-81cb-f773d2581642 55505-173 HUMAN OTC DRUG Safetussin PM Dextromethorphan Doxylamine Succinate LIQUID ORAL 20170209 OTC MONOGRAPH FINAL part341 Kramer Laboratories DEXTROMETHORPHAN; DOXYLAMINE SUCCINATE 7.5; 3.125 mg/5mL; mg/5mL N 20181231 55505-174_59af9b22-9d8a-4754-bdf0-6aa971657c57 55505-174 HUMAN OTC DRUG Fungi Nail Toe and Foot MS Zinc Undecylenate Undecylenic acid OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part333C Kramer Laboratories ZINC UNDECYLENATE; UNDECYLENIC ACID 20; 5 g/20g; g/20g N 20181231 55505-179_ea2655f1-71ce-4816-be46-aefeb995702e 55505-179 HUMAN OTC DRUG Fungi Nail Toe and Foot MS Zinc Undecylenate Undecylenic acid OINTMENT TOPICAL 20160511 OTC MONOGRAPH FINAL part333C Kramer Laboratories ZINC UNDECYLENATE; UNDECYLENIC ACID 4; 1 g/20g; g/20g N 20191231 55505-181_aaf10022-3f2d-4ebb-84c4-48a7abd63c81 55505-181 HUMAN OTC DRUG HC Max Hongo Cura Zinc Undecylenate Undecylenic acid OINTMENT TOPICAL 20160413 OTC MONOGRAPH FINAL part333C Kramer Laboratories ZINC UNDECYLENATE; UNDECYLENIC ACID 20; 5 g/100g; g/100g N 20181231 55505-182_752921c1-d38b-4142-ab4c-610a6c9e2bb3 55505-182 HUMAN OTC DRUG HC Max Hongo Cura MS Undecylenic acid SPRAY TOPICAL 20160331 OTC MONOGRAPH FINAL part333C Kramer Laboratories UNDECYLENIC ACID 25 mg/60mL N 20181231 55505-184_7d436c8b-7502-4267-88d8-e6633da923af 55505-184 HUMAN OTC DRUG Natural Fusion Anti-fungal Medi-Gel Tolnaftate GEL TOPICAL 20170801 OTC MONOGRAPH FINAL part333C Kramer Laboratories TOLNAFTATE 10 mg/g N 20181231 55505-187_703ab117-c1a0-4517-a654-3fd99e410b3a 55505-187 HUMAN OTC DRUG Fungi Nail Toe and Foot Pen Undecylenic acid LIQUID TOPICAL 20150417 OTC MONOGRAPH FINAL part333C Kramer Laboratories UNDECYLENIC ACID 250 mg/mL N 20191231 55505-189_b720f6a9-4015-4e6d-a38d-018767cfd695 55505-189 HUMAN OTC DRUG Safetussin DM Dextromethorpan Guaifenesin LIQUID ORAL 20150701 OTC MONOGRAPH FINAL part341 Kramer Laboratories DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 55505-190_f68e2d21-632b-4e9f-ab3f-5c6dea20db0c 55505-190 HUMAN OTC DRUG Safetussin PM Dextromethorphan Doxylamine Succinate LIQUID ORAL 20150701 OTC MONOGRAPH FINAL part341 Kramer Laboratories DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 7.5; 3.125 mg/5mL; mg/5mL N 20181231 55513-002_da779f39-516f-410d-ae52-80da4986f72c 55513-002 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 25 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-003_da779f39-516f-410d-ae52-80da4986f72c 55513-003 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 40 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-004_da779f39-516f-410d-ae52-80da4986f72c 55513-004 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 60 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-005_da779f39-516f-410d-ae52-80da4986f72c 55513-005 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 100 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-006_da779f39-516f-410d-ae52-80da4986f72c 55513-006 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 200 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-021_da779f39-516f-410d-ae52-80da4986f72c 55513-021 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 40 ug/.4mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-023_da779f39-516f-410d-ae52-80da4986f72c 55513-023 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 60 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-025_da779f39-516f-410d-ae52-80da4986f72c 55513-025 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 100 ug/.5mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-027_da779f39-516f-410d-ae52-80da4986f72c 55513-027 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 150 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-028_da779f39-516f-410d-ae52-80da4986f72c 55513-028 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 200 ug/.4mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-032_da779f39-516f-410d-ae52-80da4986f72c 55513-032 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060607 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 500 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-053_da779f39-516f-410d-ae52-80da4986f72c 55513-053 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060911 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 150 ug/.75mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-057_da779f39-516f-410d-ae52-80da4986f72c 55513-057 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060826 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 25 ug/.42mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-073_adef0d9b-f07c-434f-9217-ef2f45c91b91 55513-073 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20040404 NDA NDA021688 Amgen Inc CINACALCET HYDROCHLORIDE 30 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] N 20181231 55513-074_adef0d9b-f07c-434f-9217-ef2f45c91b91 55513-074 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20040404 NDA NDA021688 Amgen Inc CINACALCET HYDROCHLORIDE 60 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] N 20181231 55513-075_adef0d9b-f07c-434f-9217-ef2f45c91b91 55513-075 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20040404 NDA NDA021688 Amgen Inc CINACALCET HYDROCHLORIDE 90 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] N 20181231 55513-078_1fc8ef9c-e6a3-4a92-be6a-4718327022bd 55513-078 HUMAN PRESCRIPTION DRUG Imlygic talimogene laherparepvec INJECTION, SUSPENSION INTRALESIONAL 20151102 BLA BLA125518 Amgen Inc TALIMOGENE LAHERPAREPVEC 1000000 [PFU]/mL N 20181231 55513-079_1fc8ef9c-e6a3-4a92-be6a-4718327022bd 55513-079 HUMAN PRESCRIPTION DRUG Imlygic talimogene laherparepvec INJECTION, SUSPENSION INTRALESIONAL 20151102 BLA BLA125518 Amgen Inc TALIMOGENE LAHERPAREPVEC 100000000 [PFU]/mL N 20181231 55513-098_da779f39-516f-410d-ae52-80da4986f72c 55513-098 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060826 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 10 ug/.4mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-110_da779f39-516f-410d-ae52-80da4986f72c 55513-110 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 300 ug/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-111_da779f39-516f-410d-ae52-80da4986f72c 55513-111 HUMAN PRESCRIPTION DRUG ARANESP darbepoetin alfa INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060814 BLA BLA103951 Amgen Inc DARBEPOETIN ALFA 300 ug/.6mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-126_9fd139a6-efe9-4387-86bd-db3e6626ac80 55513-126 HUMAN PRESCRIPTION DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890630 BLA BLA103234 Amgen Inc ERYTHROPOIETIN 2000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-144_9fd139a6-efe9-4387-86bd-db3e6626ac80 55513-144 HUMAN PRESCRIPTION DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 19930816 BLA BLA103234 Amgen Inc ERYTHROPOIETIN 10000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-148_9fd139a6-efe9-4387-86bd-db3e6626ac80 55513-148 HUMAN PRESCRIPTION DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 19930816 BLA BLA103234 Amgen Inc ERYTHROPOIETIN 4000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-160_74dbaabf-ce0b-4e3c-b93e-e93e8fe9cf1a 55513-160 HUMAN PRESCRIPTION DRUG BLINCYTO blinatumomab KIT INTRAVENOUS 20141218 BLA BLA125557 Amgen Inc N 20181231 55513-190_d1070555-68d1-4770-8179-c21116bfddee 55513-190 HUMAN PRESCRIPTION DRUG Neulasta pegfilgrastim INJECTION SUBCUTANEOUS 20020401 BLA BLA125031 Amgen Inc PEGFILGRASTIM 6 mg/.6mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] N 20181231 55513-192_d1070555-68d1-4770-8179-c21116bfddee 55513-192 HUMAN PRESCRIPTION DRUG Neulasta pegfilgrastim KIT SUBCUTANEOUS 20020401 BLA BLA125031 Amgen Inc N 20181231 55513-209_b1bdec6e-58d2-405c-aa15-fdcb8ae2b38c 55513-209 HUMAN PRESCRIPTION DRUG NEUPOGEN Filgrastim INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20001002 BLA BLA103353 Amgen Inc FILGRASTIM 480 ug/.8mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] N 20181231 55513-221_427cf6ef-9240-47fa-9eb0-6706968064af 55513-221 HUMAN PRESCRIPTION DRUG Nplate romiplostim INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20080825 BLA BLA125268 Amgen Inc ROMIPLOSTIM 250 ug/.5mL Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA] N 20181231 55513-222_427cf6ef-9240-47fa-9eb0-6706968064af 55513-222 HUMAN PRESCRIPTION DRUG Nplate romiplostim INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20080825 BLA BLA125268 Amgen Inc ROMIPLOSTIM 500 ug/mL Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA] N 20181231 55513-267_9fd139a6-efe9-4387-86bd-db3e6626ac80 55513-267 HUMAN PRESCRIPTION DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 19900430 BLA BLA103234 Amgen Inc ERYTHROPOIETIN 3000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-283_9fd139a6-efe9-4387-86bd-db3e6626ac80 55513-283 HUMAN PRESCRIPTION DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 19941205 BLA BLA103234 Amgen Inc ERYTHROPOIETIN 10000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-478_9fd139a6-efe9-4387-86bd-db3e6626ac80 55513-478 HUMAN PRESCRIPTION DRUG EPOGEN epoetin alfa SOLUTION INTRAVENOUS; SUBCUTANEOUS 19970303 BLA BLA103234 Amgen Inc ERYTHROPOIETIN 20000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 55513-530_b1bdec6e-58d2-405c-aa15-fdcb8ae2b38c 55513-530 HUMAN PRESCRIPTION DRUG NEUPOGEN Filgrastim INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19970519 BLA BLA103353 Amgen Inc FILGRASTIM 300 ug/mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] N 20181231 55513-546_b1bdec6e-58d2-405c-aa15-fdcb8ae2b38c 55513-546 HUMAN PRESCRIPTION DRUG NEUPOGEN Filgrastim INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19970407 BLA BLA103353 Amgen Inc FILGRASTIM 480 ug/1.6mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] N 20181231 55513-710_f0a4aa32-b689-4a2a-b575-7b3156e79c0c 55513-710 HUMAN PRESCRIPTION DRUG Prolia denosumab INJECTION SUBCUTANEOUS 20100605 BLA BLA125320 Amgen Inc DENOSUMAB 60 mg/mL RANK Ligand Inhibitor [EPC],RANK Ligand Blocking Activity [MoA] N 20181231 55513-730_9c691b9f-98d0-459d-93a8-197e68c0aa44 55513-730 HUMAN PRESCRIPTION DRUG XGEVA denosumab INJECTION SUBCUTANEOUS 20101118 BLA BLA125320 Amgen Inc DENOSUMAB 120 mg/1.7mL RANK Ligand Inhibitor [EPC],RANK Ligand Blocking Activity [MoA] N 20191231 55513-740_4100ce15-06c6-425b-955c-de568d81371f 55513-740 HUMAN PRESCRIPTION DRUG PARSABIV etelcalcetide INJECTION, SOLUTION INTRAVENOUS 20170403 NDA NDA208325 Amgen Inc ETELCALCETIDE HYDROCHLORIDE 2.5 mg/.5mL Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] N 20181231 55513-741_4100ce15-06c6-425b-955c-de568d81371f 55513-741 HUMAN PRESCRIPTION DRUG PARSABIV etelcalcetide INJECTION, SOLUTION INTRAVENOUS 20170403 NDA NDA208325 Amgen Inc ETELCALCETIDE HYDROCHLORIDE 5 mg/mL Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] N 20181231 55513-742_4100ce15-06c6-425b-955c-de568d81371f 55513-742 HUMAN PRESCRIPTION DRUG PARSABIV etelcalcetide INJECTION, SOLUTION INTRAVENOUS 20170403 NDA NDA208325 Amgen Inc ETELCALCETIDE HYDROCHLORIDE 10 mg/2mL Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] N 20181231 55513-750_758da419-5243-402f-8e8f-cc722f9755f7 55513-750 HUMAN PRESCRIPTION DRUG REPATHA Evolocumab INJECTION, SOLUTION SUBCUTANEOUS 20150831 BLA BLA125522 Amgen Inc EVOLOCUMAB 140 mg/mL PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 55513-760_758da419-5243-402f-8e8f-cc722f9755f7 55513-760 HUMAN PRESCRIPTION DRUG REPATHA Evolocumab INJECTION, SOLUTION SUBCUTANEOUS 20150831 BLA BLA125522 Amgen Inc EVOLOCUMAB 140 mg/mL PCSK9 Inhibitor [EPC],PCSK9 Inhibitors [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 55513-770_758da419-5243-402f-8e8f-cc722f9755f7 55513-770 HUMAN PRESCRIPTION DRUG REPATHA Evolocumab KIT SUBCUTANEOUS 20160801 BLA BLA125522 Amgen Inc N 20181231 55513-800_3e7b938c-0792-47e4-9e0c-ae0f1a186dc9 55513-800 HUMAN PRESCRIPTION DRUG Corlanor ivabradine TABLET, FILM COATED ORAL 20150420 NDA NDA206143 Amgen Inc IVABRADINE HYDROCHLORIDE 5 mg/1 Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC],Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA] N 20181231 55513-810_3e7b938c-0792-47e4-9e0c-ae0f1a186dc9 55513-810 HUMAN PRESCRIPTION DRUG Corlanor ivabradine TABLET, FILM COATED ORAL 20150420 NDA NDA206143 Amgen Inc IVABRADINE HYDROCHLORIDE 7.5 mg/1 Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC],Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA] N 20181231 55513-924_b1bdec6e-58d2-405c-aa15-fdcb8ae2b38c 55513-924 HUMAN PRESCRIPTION DRUG NEUPOGEN Filgrastim INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20001002 BLA BLA103353 Amgen Inc FILGRASTIM 300 ug/.5mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] N 20181231 55513-954_66724e29-088b-40a9-8d6f-979bda438cf2 55513-954 HUMAN PRESCRIPTION DRUG Vectibix panitumumab SOLUTION INTRAVENOUS 20061010 BLA BLA125147 Amgen Inc PANITUMUMAB 100 mg/5mL Epidermal Growth Factor Receptor Antagonist [EPC],HER1 Antagonists [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 55513-956_66724e29-088b-40a9-8d6f-979bda438cf2 55513-956 HUMAN PRESCRIPTION DRUG Vectibix panitumumab SOLUTION INTRAVENOUS 20061010 BLA BLA125147 Amgen Inc PANITUMUMAB 400 mg/20mL Epidermal Growth Factor Receptor Antagonist [EPC],HER1 Antagonists [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 55526-0001_2124abe4-54f9-49f7-90ac-605880db7be8 55526-0001 HUMAN OTC DRUG NAVI Amazon Propol Sodium Monofluorophosphate Silicon Dioxide PASTE DENTAL 20130101 OTC MONOGRAPH FINAL part355 EQ Maxon Corp. SODIUM MONOFLUOROPHOSPHATE .228 g/120g E 20171231 55526-0002_c4888dd7-09e0-4fde-9bb6-02482e6b920f 55526-0002 HUMAN OTC DRUG NAVI Mate Gold Sodium Monofluorophosphate Silicon Dioxide PASTE DENTAL 20130401 OTC MONOGRAPH FINAL part355 EQ Maxon Corp. SILICON DIOXIDE; SODIUM MONOFLUOROPHOSPHATE 21.36; .552 g/120g; g/120g E 20171231 55526-0003_ac503a2f-0729-4a5c-a8ad-3735cf01804c 55526-0003 HUMAN OTC DRUG NAVI Mate Silver Sodium Monofluorophosphate Silicon Dioxide PASTE DENTAL 20130401 OTC MONOGRAPH FINAL part355 EQ Maxon Corp. SILICON DIOXIDE; SODIUM MONOFLUOROPHOSPHATE 21.36; .552 g/120g; g/120g E 20171231 55526-0004_01092e9c-1fac-4315-b392-fe404e207900 55526-0004 HUMAN OTC DRUG NAVI MAXON Sirin Doctor Calcium Phosphate Tribasic Colloidal Silicon Dioxide PASTE DENTAL 20130401 OTC MONOGRAPH FINAL part331 EQ Maxon Corp. TRICALCIUM PHOSPHATE; SILICON DIOXIDE 22.8; 3 g/120g; g/120g E 20171231 55526-0005_7e7ed651-e324-4cb0-b255-8fc155f8a115 55526-0005 HUMAN OTC DRUG NAVI Black and C-Clinic Calcium Carbonate Aminocaproic Acid Aluminum Chlorohydroxy Allantoinate Dibasic Calcium Phosphate PASTE DENTAL 20130401 OTC MONOGRAPH FINAL part331 EQ Maxon Corp. CALCIUM CARBONATE; AMINOCAPROIC ACID; DIBASIC CALCIUM PHOSPHATE DIHYDRATE 48; .12; .12 g/120g; g/120g; g/120g E 20171231 55528-001_169f2a7e-4fb3-44e4-b588-44451a775dea 55528-001 HUMAN OTC DRUG DAILY ESSENTIAL MOISTURISER Homosalate, Octisalate, Avobenzone, Octocrylene, Oxybenzone LOTION TOPICAL 20130115 OTC MONOGRAPH FINAL part352 INTERNATIONAL WATERS PTY. LTD. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE; OXYBENZONE 100; 50; 40; 20; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55531-001_abd6bda9-3994-4215-8e55-6c325f5c5516 55531-001 HUMAN OTC DRUG Medicated Green Oil MENTHOL, METHYL SALICYLATE OIL TOPICAL 20130702 OTC MONOGRAPH NOT FINAL part348 Allways Health-Care Corporation Limited MENTHOL; METHYL SALICYLATE 160; 300 mg/100mL; mg/100mL E 20171231 55533-520_7c5737a4-71be-40c7-90e1-e10c2cd0b1d9 55533-520 HUMAN OTC DRUG HEALTHY HANDS ALOE INSTANT HAND ANTIBACTERIAL ALCOHOL SOAP TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part333E NCH Corporation ALCOHOL .62 mL/mL E 20171231 55533-522_7a7a7ec5-30b6-418c-80ee-1be515e761e3 55533-522 HUMAN OTC DRUG Healthy Hands Instant Antiseptic Hand Cleanser ALCOHOL SOLUTION TOPICAL 20001101 OTC MONOGRAPH NOT FINAL part333E NCH Corporation ALCOHOL 42 mg/25mL E 20171231 55533-529_46b0287f-15df-4788-be92-777d8d23de41 55533-529 HUMAN OTC DRUG HEALTHY HANDS PINK ANTIBACTERIAL HAND CLEANER CHLOROXYLENOL SOAP TOPICAL 20140121 OTC MONOGRAPH NOT FINAL part333E NCH Corporation CHLOROXYLENOL 2.5 g/1000mL E 20171231 55533-556_ec761484-6e54-418c-86c6-0d326f484340 55533-556 HUMAN OTC DRUG HEALTHY HANDS INSTANT ANTISEPTIC HAND CLEANSER WITH MOISTURIZERS ALCOHOL SOAP TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333E NCH Corporation ALCOHOL .62 mL/mL E 20171231 55533-682_85c28d80-ccc1-4d73-89a7-edd9fb33cf07 55533-682 HUMAN OTC DRUG HEALTHY HANDS SANITIZING HAND WIPES WITH ALOE BENZALKONIUM CHLORIDE CLOTH TOPICAL 20140429 OTC MONOGRAPH NOT FINAL part333E NCH Corporation BENZALKONIUM CHLORIDE .0067275 g/1 E 20171231 55545-1000_a4cd6743-0942-4ae6-b2d4-8a23786b86d4 55545-1000 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 20141215 ANDA ANDA077259 FDC Limited TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55545-1001_5de7796b-8c4b-4e1a-96c2-3ee63a576a68 55545-1001 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 20141215 ANDA ANDA077259 FDC Limited TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55545-1003_d2b7e684-27f1-4ee7-b235-58b632ac9694 55545-1003 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION OPHTHALMIC 20141215 ANDA ANDA078559 FDC Limited OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55545-1010_e3ce3b6b-f8b7-4f89-9987-b81ff031ad2a 55545-1010 HUMAN PRESCRIPTION DRUG LATANOPROST latanoprost SOLUTION OPHTHALMIC 20160901 ANDA ANDA202442 FDC Limited LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 55546-0001_6bd93f15-cc88-4159-9b89-08a7c79945ec 55546-0001 HUMAN OTC DRUG Male Formula Plus Avena Sativa, Carduus Marianus, Damiana, Galium Aparine,Hamamelis Virginiana, Hepar Bovine, Korean Ginseng, Nuphar Luteum Tincture LIQUID ORAL 20130822 UNAPPROVED HOMEOPATHIC Yuen Method AVENA SATIVA FLOWERING TOP; SILYBUM MARIANUM SEED; TURNERA DIFFUSA LEAFY TWIG; GALIUM APARINE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; BEEF LIVER; ASIAN GINSENG; NUPHAR LUTEUM ROOT; BOS TAURUS TESTICLE; POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF; TESTOSTERONE; THUJA OCCIDENTALIS LEAF 1; 1; 1; 3; 1; 6; 1; 2; 6; 1; 1; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 55550-000_60efb728-13d9-0a34-e053-2a91aa0a6a59 55550-000 HUMAN OTC DRUG FIRST AID Plus More ALCOHOL Prep Pad ALCOHOL LIQUID TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part333E Total Resources International Inc ALCOHOL 70 mL/100mL N 20181231 55550-001_60f07529-ef8f-0684-e053-2991aa0a7809 55550-001 HUMAN OTC DRUG FIRST AID Plus More Quick n Clean Antiseptic Hand Wipe BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part333E Total Resources International Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55550-002_576fc260-279f-5376-e053-2991aa0ac317 55550-002 HUMAN OTC DRUG ANTISEPTIC WIPE benzalkonium chloride PATCH TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part333A Total Resources International BENZALKONIUM CHLORIDE .13 g/100g N 20181231 55550-020_576f7681-ad33-cbb3-e053-2a91aa0a514a 55550-020 HUMAN OTC DRUG STERILE ALCOHOL PREP PADS isopropyl alcohol SWAB TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part333A Total Resources International ISOPROPYL ALCOHOL .7 mL/mL N 20181231 55550-030_94eb6951-7b31-412a-9d92-88865574f801 55550-030 HUMAN OTC DRUG Alcohol Prep Pads Isopropyl Alcohol LIQUID TOPICAL 20131107 OTC MONOGRAPH NOT FINAL part333A Total Resources International ISOPROPYL ALCOHOL .7 mL/mL N 20181231 55550-031_f90ed16e-6c59-4c0b-86e1-00f813691493 55550-031 HUMAN OTC DRUG Sterile Alcohol Prep Pads Isopropyl Alcohol LIQUID TOPICAL 20131112 OTC MONOGRAPH NOT FINAL part333A Total Resources International ISOPROPYL ALCOHOL .7 mL/mL N 20181231 55550-102_e4b994ea-01bf-40e9-9cbe-bb0807174ec2 55550-102 HUMAN OTC DRUG Sunscreen Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20070313 OTC MONOGRAPH NOT FINAL part352 Total Resources International HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 6; 7.5; 5; 5 mg/g; mg/g; mg/g; mg/g N 20181231 55550-200_5e11bc77-c763-455b-bab8-19b0b917a80b 55550-200 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333E Total Resources International BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55550-500_2ea6e9c0-e6de-74d2-e054-00144ff8d46c 55550-500 HUMAN OTC DRUG EYE WASH EYE WASH LIQUID OPHTHALMIC 20160316 OTC MONOGRAPH FINAL part349 Total Resources International WATER 99.1 mL/100mL E 20171231 55550-700_61f7936a-5633-bbaf-e053-2991aa0a8923 55550-700 HUMAN OTC DRUG Eye Wash WATER LIQUID OPHTHALMIC 20180104 OTC MONOGRAPH FINAL part349 Total Resources International WATER 991 mg/mL N 20191231 55560-0101_757dfc23-b1ba-4fb5-bfc4-fd771f4e155e 55560-0101 HUMAN OTC DRUG Andalou BB Untinted with SPF-30 Zinc Oxide LOTION TOPICAL 20121210 OTC MONOGRAPH FINAL part352 Andalou naturals ZINC OXIDE 20 g/100mL E 20171231 55560-0102_1520ddfd-7577-43ce-a2fe-caeacd81870f 55560-0102 HUMAN OTC DRUG Andalou BB sheer tint with SPF-30 Zinc Oxide LOTION TOPICAL 20121210 OTC MONOGRAPH FINAL part352 Andalou naturals ZINC OXIDE 20 g/100mL E 20171231 55560-0103_a1405bf6-7522-4d58-84b7-073b5300e81a 55560-0103 HUMAN OTC DRUG 1000 Roses Daily Shade Facial SPF 18 Octisalate, Octocrylene, and Avobenzone LOTION TOPICAL 20140301 OTC MONOGRAPH FINAL part352 Andalou Naturals OCTISALATE; OCTOCRYLENE; AVOBENZONE 50; 50; 25 mg/mL; mg/mL; mg/mL N 20181231 55560-0104_ac994f01-80b5-4cc8-ae86-50e16675c0bf 55560-0104 HUMAN OTC DRUG Perfecting BB Beauty Balm Natural Tint SPF 30 Zinc Oxide LOTION TOPICAL 20121210 OTC MONOGRAPH FINAL part352 Andalou Naturals ZINC OXIDE 200 mg/mL N 20181231 55560-0105_2f9fb19c-df4c-47ba-a4ea-be36df7022a2 55560-0105 HUMAN OTC DRUG 1000 Roses CC Color plus Correct Sheer Nude SPF 30 Zinc Oxide LOTION TOPICAL 20140301 OTC MONOGRAPH FINAL part352 Andalou Naturals ZINC OXIDE 200 mg/mL N 20181231 55560-0106_3fbabbc2-9188-432c-8edb-e1ad4ee3e71a 55560-0106 HUMAN OTC DRUG 1000 Roses CC Color Plus Correct Sheer Tan SPF 30 Zinc Oxide LOTION TOPICAL 20140301 OTC MONOGRAPH FINAL part352 Andalou Naturals ZINC OXIDE 200 mg/mL N 20181231 55560-0107_a7d8a5c6-b660-40b9-ae7c-5812aaac581a 55560-0107 HUMAN OTC DRUG DIY Booster SPF 30 Facial Serum Unscented Octinoxate, Octisalate, Avobenzone, and Zinc Oxide LOTION TOPICAL 20140301 OTC MONOGRAPH FINAL part352 Andalou Naturals OCTINOXATE; OCTISALATE; AVOBENZONE; ZINC OXIDE 70; 50; 30; 1 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55560-0108_fe3c3bc5-9ff7-4a06-9361-47a87b39ec18 55560-0108 HUMAN OTC DRUG Vitamin C BB Beauty Balm Sheer Tint SFP 30 Zinc Oxide LOTION TOPICAL 20121210 OTC MONOGRAPH FINAL part352 Andalou Naturals ZINC OXIDE 200 mg/mL N 20181231 55560-0109_b802db8f-9abb-4822-bca5-c21688af1972 55560-0109 HUMAN OTC DRUG Argan Stem Cell BB Benefit Balm Un-Tinted SFP 30 Zinc Oxide LOTION TOPICAL 20121210 OTC MONOGRAPH FINAL part352 Andalou Naturals ZINC OXIDE 200 mg/mL N 20181231 55560-1810_84659b11-d145-49ab-bf7c-3b60e73e0b29 55560-1810 HUMAN OTC DRUG Blemish Vanishing Salicylic Acid GEL TOPICAL 20110301 OTC MONOGRAPH FINAL part333D Andalou Naturals SALICYLIC ACID 20 mg/mL N 20181231 55560-1811_c693aabe-197d-4309-bba0-de295ddc5728 55560-1811 HUMAN OTC DRUG Ultra Sheer Daily Defense Facial SPF 18 Octisalate, Octocrylene, and Avobenzone LOTION TOPICAL 20110301 OTC MONOGRAPH FINAL part352 Andalou Naturals OCTISALATE; OCTOCRYLENE; AVOBENZONE 50; 50; 25 mg/mL; mg/mL; mg/mL N 20181231 55566-0302_4698848e-3251-49f8-bcac-614fd485c784 55566-0302 HUMAN PRESCRIPTION DRUG Acthrel Corticorelin ovine triflutate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960523 NDA NDA020162 Ferring Pharmaceuticals Inc. CORTICORELIN OVINE TRIFLUTATE 100 ug/2mL N 20181231 55566-1501_63afb761-d61a-7fd1-e053-2991aa0a9430 55566-1501 HUMAN PRESCRIPTION DRUG Novarel Gonadotrophin, Chorionic KIT 19740115 NDA NDA017016 Ferring Pharmaceuticals Inc. N 20191231 55566-1502_63afb761-d61a-7fd1-e053-2991aa0a9430 55566-1502 HUMAN PRESCRIPTION DRUG Novarel Gonadotrophin, Chorionic KIT 19740115 NDA NDA017016 Ferring Pharmaceuticals Inc. N 20191231 55566-1801_19fb0218-6cda-4890-9b1d-2604e9e9179b 55566-1801 HUMAN PRESCRIPTION DRUG ZOMACTON somatropin KIT 19950525 NDA NDA019774 Ferring Pharmaceuticals Inc. N 20181231 55566-1901_19fb0218-6cda-4890-9b1d-2604e9e9179b 55566-1901 HUMAN PRESCRIPTION DRUG ZOMACTON somatropin KIT SUBCUTANEOUS 20150301 NDA NDA019774 Ferring Pharmaceuticals Inc. N 20181231 55566-2110_fa9c91fd-c59a-479a-8107-e26cdba94075 55566-2110 HUMAN PRESCRIPTION DRUG Lysteda Tranexamic Acid TABLET ORAL 20100517 NDA NDA022430 Ferring Pharmaceuticals Inc. TRANEXAMIC ACID 650 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 55566-2200_64799128-05cd-bacd-e053-2991aa0a035b 55566-2200 HUMAN PRESCRIPTION DRUG DDAVP Desmopressin Acetate INJECTION INTRAVENOUS 19840330 NDA NDA018938 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20191231 55566-2300_64799128-05cd-bacd-e053-2991aa0a035b 55566-2300 HUMAN PRESCRIPTION DRUG DDAVP Desmopressin Acetate INJECTION INTRAVENOUS 19840330 NDA NDA018938 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20191231 55566-2400_5542c08d-5c39-4f07-84cc-96592576f518 55566-2400 HUMAN PRESCRIPTION DRUG DDAVP Desmopressin Acetate SPRAY NASAL 19780221 NDA NDA017922 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE .1 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 55566-2500_8f2242f6-975f-4d29-963b-19d91e5c7923 55566-2500 HUMAN PRESCRIPTION DRUG DDAVP Desmopressin Acetate SPRAY NASAL 19780221 NDA NDA017922 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE .1 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 55566-2600_63af0769-694e-15b2-e053-2991aa0a6f62 55566-2600 HUMAN PRESCRIPTION DRUG DDAVP Desmopressin Acetate TABLET ORAL 19950906 NDA NDA019955 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20191231 55566-2700_63af0769-694e-15b2-e053-2991aa0a6f62 55566-2700 HUMAN PRESCRIPTION DRUG DDAVP Desmopressin Acetate TABLET ORAL 19950906 NDA NDA019955 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20191231 55566-2800_81695e0b-003b-4c39-9cd0-0bd2695c6340 55566-2800 HUMAN PRESCRIPTION DRUG CERVIDIL DINOPROSTONE INSERT VAGINAL 19950330 NDA NDA020411 Ferring Pharmaceuticals Inc. DINOPROSTONE 10 mg/241mg Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 55566-5020_dbfe4d67-5335-5333-debb-428f6f991de6 55566-5020 HUMAN PRESCRIPTION DRUG Desmopressin Acetate desmopressin acetate SOLUTION NASAL 19990810 NDA NDA017922 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 55566-5030_90bd1e51-06c1-61ab-fc0e-32c4dbd3b7a7 55566-5030 HUMAN PRESCRIPTION DRUG Desmopressin Acetate desmopressin acetate SOLUTION INTRAVENOUS 19991026 NDA NDA018938 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] E 20171231 55566-5040_90bd1e51-06c1-61ab-fc0e-32c4dbd3b7a7 55566-5040 HUMAN PRESCRIPTION DRUG Desmopressin Acetate desmopressin acetate SOLUTION INTRAVENOUS 19991026 NDA NDA018938 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 55566-5060_a3e1a3bc-b2d8-4947-87de-f1bb016fc8a3 55566-5060 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin acetate TABLET ORAL 20080505 NDA NDA021795 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] E 20171231 55566-5061_a3e1a3bc-b2d8-4947-87de-f1bb016fc8a3 55566-5061 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin acetate TABLET ORAL 20080505 NDA NDA021795 Ferring Pharmaceuticals Inc. DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 55566-6500_9f3482aa-b8a8-4d11-86b1-45209b2587b6 55566-6500 HUMAN PRESCRIPTION DRUG ENDOMETRIN Progesterone INSERT VAGINAL 20070621 NDA NDA022057 Ferring Pharmaceuticals Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 55566-6700_61e281ca-34ff-b356-e053-2a91aa0a582f 55566-6700 HUMAN PRESCRIPTION DRUG CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID LIQUID ORAL 20171128 NDA NDA209589 Ferring Pharmaceuticals Inc. SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID 10; 3.5; 12 mg/160mL; g/160mL; g/160mL Increased Large Intestinal Motility [PE],Stimulant Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20191231 55566-7501_bc3fd1c5-8cb4-4aac-94f7-2a9f2dd717e7 55566-7501 HUMAN PRESCRIPTION DRUG Menopur menotropins KIT 20041029 NDA NDA021663 Ferring Pharmaceuticals Inc. N 20181231 55566-8303_63ae1d4a-c428-6657-e053-2991aa0af037 55566-8303 HUMAN PRESCRIPTION DRUG FIRMAGON Degarelix KIT 20090302 NDA NDA022201 Ferring Pharmaceuticals Inc. N 20191231 55566-8403_63ae1d4a-c428-6657-e053-2991aa0af037 55566-8403 HUMAN PRESCRIPTION DRUG FIRMAGON Degarelix KIT 20090302 NDA NDA022201 Ferring Pharmaceuticals Inc. N 20191231 55566-8505_af590fbf-a3fd-4b69-986b-186f8ac242bd 55566-8505 HUMAN PRESCRIPTION DRUG Bravelle Urofollitropin KIT SUBCUTANEOUS 20020506 NDA NDA021289 Ferring Pharmaceuticals Inc. N 20181231 55566-9300_63b021a5-b5f6-4ccf-e053-2a91aa0aa143 55566-9300 HUMAN PRESCRIPTION DRUG PREPOPIK SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID POWDER, METERED ORAL 20120716 NDA NDA202535 Ferring Pharmaceuticals Inc. SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID 10; 3.5; 12 mg/16.1g; g/16.1g; g/16.1g Increased Large Intestinal Motility [PE],Stimulant Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20191231 55566-9500_9c6dfdbe-d7c1-474d-abb9-fafd3f9f5711 55566-9500 HUMAN PRESCRIPTION DRUG DINOPROSTONE DINOPROSTONE INSERT VAGINAL 20140201 NDA NDA020411 Ferring Pharmaceuticals Inc. DINOPROSTONE 10 mg/241mg Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 55566-9700_63b021a5-b5f6-4ccf-e053-2a91aa0aa143 55566-9700 HUMAN PRESCRIPTION DRUG PREPOPIK SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID POWDER, METERED ORAL 20140905 NDA NDA202535 Ferring Pharmaceuticals Inc. SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID 10; 3.5; 12 mg/16.2g; g/16.2g; g/16.2g Increased Large Intestinal Motility [PE],Stimulant Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20191231 55586-001_5d9533f9-ee81-488b-99d6-e49f44733ee0 55586-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19710101 UNAPPROVED MEDICAL GAS Sims Welding Supply Co, Inc. OXYGEN 99 L/100L E 20171231 55607-400_25fc4057-7e8d-4944-816f-9fe798ab5003 55607-400 HUMAN PRESCRIPTION DRUG Prastera prasterone and ibuprofen KIT ORAL 20140404 UNAPPROVED DRUG OTHER Health Science Funding, LLC N 20181231 55614-100_71ceeab2-7c0d-4a99-92f4-dd7ca530ebd3 55614-100 HUMAN OTC DRUG SOLSTICE MEDICINE COMPANY PAIN RELIEF Camphor, Menthol, Methyl Salicylate PATCH TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part348 MADISON ONE ACME INC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 8.3; 3.32; 13.84 g/1; g/1; g/1 E 20171231 55618-1001_62bbe3ca-4f5c-4dab-a559-00cdbd1c0365 55618-1001 HUMAN OTC DRUG Jilgyungyi ALLANTOIN TABLET VAGINAL 20130611 UNAPPROVED DRUG OTHER HA U DONG CHUN ALLANTOIN .2 1/1 E 20171231 55618-2001_19856cd9-ba1c-06a4-e054-00144ff8d46c 55618-2001 HUMAN OTC DRUG MIRACLE GYN ALLANTOIN TABLET VAGINAL 20150626 UNAPPROVED DRUG OTHER HA U DONG CHUN ALLANTOIN .2 1/1 E 20171231 55618-2002_274f26f1-ebbd-4852-aba3-23f0f475ddd8 55618-2002 HUMAN OTC DRUG Miracle GYN (2 Tablets) Allantoin TABLET VAGINAL 20160706 UNAPPROVED DRUG OTHER Haudongchun Co., Ltd. ALLANTOIN .11 1/600mg N 20181231 55618-2003_e65f9b4d-9935-48bd-bd97-f605cf9da06e 55618-2003 HUMAN OTC DRUG Miracle GYN (10 Tablets) Allantoin TABLET VAGINAL 20160707 UNAPPROVED DRUG OTHER Haudongchun Co., Ltd. ALLANTOIN .11 1/600mg N 20181231 55618-2004_8af4a8d4-7142-4e80-ac01-3e3ffe5ecda8 55618-2004 HUMAN OTC DRUG Jilgyungyi (20 Tablets) Allantoin TABLET VAGINAL 20160707 UNAPPROVED DRUG OTHER Haudongchun Co., Ltd. ALLANTOIN .11 1/600mg E 20171231 55618-2005_284abbdb-49f3-4d65-b7dc-4a3232f13279 55618-2005 HUMAN OTC DRUG Jilgyungyi (10 Tablets) Allantoin TABLET VAGINAL 20170315 UNAPPROVED DRUG OTHER Haudongchun Co., Ltd. ALLANTOIN .11 1/600mg N 20181231 55618-2006_fb5d64e5-f46f-46be-a5da-7a936632f1c0 55618-2006 HUMAN OTC DRUG Secret Gyno (10 Tablets) Allantoin TABLET VAGINAL 20170315 UNAPPROVED DRUG OTHER Haudongchun Co., Ltd. ALLANTOIN .11 1/600mg N 20181231 55618-2007_552b2c78-00ba-2df0-e054-00144ff8d46c 55618-2007 HUMAN OTC DRUG Jilgyungyi (6 Tablets) Allantoin TABLET VAGINAL 20170725 UNAPPROVED DRUG OTHER Haudongchun Co., Ltd. ALLANTOIN 66 mg/600mg N 20181231 55618-2008_575bf24b-6075-7490-e053-2991aa0a1993 55618-2008 HUMAN OTC DRUG Miracle GYN (4 Tablets) Allantoin TABLET VAGINAL 20170822 UNAPPROVED DRUG OTHER Haudongchun Co., Ltd. ALLANTOIN 66 mg/600mg N 20181231 55621-001_4233a5e5-cd03-4828-8824-95396c86a484 55621-001 HUMAN OTC DRUG Thera Plus Hydrocortisone CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Zhejiang Jingwei Pharmaceutical Co., Ltd. HYDROCORTISONE 1 g/100g N 20181231 55621-002_7031fcd6-ab38-4fd0-9188-8a20156aab96 55621-002 HUMAN OTC DRUG TheraPlusPlus Plus NEOMYCIN OINTMENT TOPICAL 20130301 OTC MONOGRAPH FINAL part333B Zhejiang Jingwei Pharmaceutical Co., Ltd. BACITRACIN; NEOMYCIN; POLYMYXIN B .41; .0035; .52 g/100g; g/100g; g/100g N 20181231 55621-003_9e9abe6d-0210-41d5-8cd0-e1985c46bbb3 55621-003 HUMAN OTC DRUG TheraPlus Plus CLOTRIMAZOLE CREAM TOPICAL 20130301 OTC MONOGRAPH FINAL part333C Zhejiang Jingwei Pharmaceutical Co., Ltd. CLOTRIMAZOLE 1 g/100g N 20181231 55621-004_8cefcdd3-4abd-4bee-a23d-638f6139c459 55621-004 HUMAN OTC DRUG TheraPlus Plus Menthol OINTMENT TOPICAL 20130301 OTC MONOGRAPH FINAL part348 Zhejiang Jingwei Pharmaceutical Co., Ltd. MENTHOL; MENTHYL SALICYLATE, (+/-)- 10; 15 g/100g; g/100g N 20181231 55621-005_82084c58-86b2-4fe2-a5b5-7ea76b7efc63 55621-005 HUMAN OTC DRUG TheraPlus Plus Phenylephrine HCI OINTMENT TOPICAL 20130301 OTC MONOGRAPH FINAL part346 Zhejiang Jingwei Pharmaceutical Co., Ltd. PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL; PETROLATUM .25; 14; 74.9 g/100g; g/100g; g/100g N 20181231 55621-006_80425369-2751-46f7-8b55-416e08435e9e 55621-006 HUMAN OTC DRUG Family Wellness Phenylephrine HCI, PETROLATUM, MINERAL OIL OINTMENT RECTAL; TOPICAL 20131101 OTC MONOGRAPH FINAL part346 Zhejiang Jingwei Pharmaceutical Co., Ltd. PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL; PETROLATUM .25; 14; 74.9 g/100g; g/100g; g/100g N 20181231 55621-007_86b3a888-70c2-4784-910c-6fdfd8a94345 55621-007 HUMAN OTC DRUG Family Wellness DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part348 Zhejiang Jingwei Pharmaceutical Co., Ltd. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 55621-008_40733a11-a835-40a3-b762-f96cbb53180b 55621-008 HUMAN OTC DRUG Family Wellness Hydrocortisone CREAM TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Zhejiang Jingwei Pharmaceutical Co., Ltd. HYDROCORTISONE 1 g/100g N 20181231 55621-009_848dc2d4-16e0-43e9-9311-ebdae28d3cdf 55621-009 HUMAN OTC DRUG Family Wellness NEOMYCIN, BACITRACIN, POLYMYXIN OINTMENT TOPICAL 20130301 OTC MONOGRAPH FINAL part333B Zhejiang Jingwei Pharmaceutical Co., Ltd. BACITRACIN; NEOMYCIN; POLYMYXIN B .41; .0035; .52 g/100g; g/100g; g/100g N 20181231 55621-010_272a9428-b197-4680-a605-7338660d5c39 55621-010 HUMAN OTC DRUG Assured LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part348 Zhejiang Jingwei Pharmaceutical Co., Ltd. LIDOCAINE HYDROCHLORIDE 2.5 g/100g N 20181231 55621-011_68e14b59-ef61-44c6-940c-8bb6197e0779 55621-011 HUMAN OTC DRUG Assured Bikini Smooth Cream LIDOCAINE CREAM TOPICAL 20151030 OTC MONOGRAPH FINAL part346 Zhejiang Jingwei Pharmaceutical Co., Ltd. LIDOCAINE 2 g/100g N 20181231 55621-012_49425094-fe07-40ce-a6f1-5ebcc2762d9f 55621-012 HUMAN OTC DRUG Family Wellness GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM CREAM TOPICAL 20160714 OTC MONOGRAPH FINAL part346 Zhejiang Jingwei Pharmaceutical Co., Ltd. GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 55621-014_23de485e-6251-423d-969f-dcfaeed66383 55621-014 HUMAN OTC DRUG Family Wellness BENZOCAINE, RESORCINOL CREAM TOPICAL 20170803 OTC MONOGRAPH NOT FINAL part348 Zhejiang Jingwei Pharmaceutic Al Co., Ltd. BENZOCAINE; RESORCINOL 2; .03 g/100g; g/100g N 20181231 55621-015_2ee61530-6d39-4c00-a539-a09812b5d7e3 55621-015 HUMAN OTC DRUG Modesa Acne Treatment BENZOYL PEROXIDE CREAM TOPICAL 20170803 OTC MONOGRAPH FINAL part333D Zhejiang Jingwei Pharmaceutic Al Co., Ltd. BENZOYL PEROXIDE 1 g/100g N 20181231 55628-1001_64cb6819-dc8d-408c-b19d-5791a4a96723 55628-1001 HUMAN OTC DRUG ULTRA THERAPY PAIN RELIEF MENTHOL, METHYL SALICYLATE, CAPSAICIN LOTION TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part348 Cal Pharma MENTHOL; METHYL SALICYLATE; CAPSAICIN 10; 28; .025 g/100mL; g/100mL; g/100mL N 20181231 55628-8477_30fd3fd6-ea80-4f3c-8378-91eb4a913dec 55628-8477 HUMAN OTC DRUG SPF Rx - Anti-Aging Sunscreen SPF 30 Avobenzone, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part352 Cal Pharma LLC OCTOCRYLENE; OCTISALATE; AVOBENZONE; OXYBENZONE 2.8; 4.75; 2.75; 4.25 g/100g; g/100g; g/100g; g/100g N 20181231 55628-8569_79e6154c-02f5-4d74-a7c6-bf937e5848a8 55628-8569 HUMAN OTC DRUG SPF Rx - Mineral Sunscreen SPF 30 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170730 OTC MONOGRAPH NOT FINAL part352 Cal Pharma LLC ZINC OXIDE; TITANIUM DIOXIDE 5; 3 g/100g; g/100g N 20181231 55628-8585_d729f6d8-acca-4cd4-b1f3-ae5cb1e88045 55628-8585 HUMAN OTC DRUG SPF Rx - Ultra-Clear Daily Skin Hydrator SPF 50 Zinc Oxide, Octinoxate CREAM TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part352 Cal Pharma LLC ZINC OXIDE; OCTINOXATE 9; 7.5 g/100g; g/100g N 20181231 55628-8626_b18b8e87-2740-4d5b-adee-a5762b343676 55628-8626 HUMAN OTC DRUG SPF Rx - Mineral Sunscreen SPF 50 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170730 OTC MONOGRAPH NOT FINAL part352 Cal Pharma LLC ZINC OXIDE; TITANIUM DIOXIDE 7; 5 g/100g; g/100g N 20181231 55628-8824_f8806110-a5e6-494b-866b-c7f615330698 55628-8824 HUMAN OTC DRUG SPF Rx - Sport Sunscreen SPF 30 Homosalate, Octocrylene, Octisalate, Avobenzone CREAM TOPICAL 20170730 OTC MONOGRAPH NOT FINAL part352 Cal Pharma LLC HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 12; 4.8; 4; 2.4 g/100g; g/100g; g/100g; g/100g N 20181231 55628-8834_de5c8af8-0df3-49c4-8d09-190db5c88d77 55628-8834 HUMAN OTC DRUG SPF Rx - Sport Sunscreen SPF 50 Homosalate, Octocrylene, Octisalate, Avobenzone CREAM TOPICAL 20170730 OTC MONOGRAPH NOT FINAL part352 Cal Pharma LLC HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 12; 4.8; 4; 2.4 g/100g; g/100g; g/100g; g/100g N 20181231 55628-9047_b3eabd44-4b5d-4ee5-bd59-e008b7c5da63 55628-9047 HUMAN OTC DRUG ULTRACIN T TROLAMINE SALICYLATE LOTION TOPICAL 20150804 OTC MONOGRAPH NOT FINAL part348 Cal Pharma TROLAMINE SALICYLATE 10 g/100mL N 20181231 55628-9051_e4a41d64-ca6d-4f45-a3aa-c40e72b1c259 55628-9051 HUMAN OTC DRUG ULTRACIN M MENTHOL GEL TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part348 Cal Pharma MENTHOL 10 g/100mL N 20181231 55628-9107_77087b7e-0a55-4aad-8c55-a2bac2398835 55628-9107 HUMAN OTC DRUG ULTRACIN M MENTHOL GEL TOPICAL 20160124 OTC MONOGRAPH NOT FINAL part348 Cal Pharma MENTHOL 5 g/100mL N 20181231 55628-9109_2889fdb4-365d-4adb-840e-b4257c173427 55628-9109 HUMAN OTC DRUG THERASEPTIN ZINC OXIDE MENTHOL OINTMENT TOPICAL 20121129 OTC MONOGRAPH FINAL part347 Cal Pharma ZINC OXIDE; MENTHOL 20.6; .5 g/100mL; g/100mL E 20171231 55628-9155_5ac733c8-3e67-4cd7-8500-f99e18bb52f4 55628-9155 HUMAN OTC DRUG THERAZCREAM TRICLOSAN CREAM TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part333A Cal Pharma TRICLOSAN .3 g/100mL N 20181231 55628-9179_497e9e0c-4729-4e68-bf9c-d77847e939bf 55628-9179 HUMAN OTC DRUG ULTRACIN METHYL SALICYLATE, MENTHOL, CAPSAICIN LOTION TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part348 Cal Pharma MENTHOL; METHYL SALICYLATE; CAPSAICIN 10; 28; 25 g/100mL; g/100mL; mg/100mL N 20181231 55628-9204_d1d12c3e-0c3c-4289-8244-ab4db423682f 55628-9204 HUMAN OTC DRUG THERASEPTIN ZINC OXIDE, MENTHOL OINTMENT TOPICAL 20121129 OTC MONOGRAPH FINAL part347 Cal Pharma ZINC OXIDE; MENTHOL 20.6; .5 g/100mL; g/100mL N 20181231 55628-9228_7ca955a4-de71-468b-94e7-73ffd0b0da63 55628-9228 HUMAN OTC DRUG SPF Rx - Mineral Sunscreen SPF 40 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170730 OTC MONOGRAPH NOT FINAL part352 Cal Pharma LLC ZINC OXIDE; TITANIUM DIOXIDE 20; 1 g/100g; g/100g N 20181231 55628-9565_ca5bd213-f8bd-447a-9697-e817c5773bf5 55628-9565 HUMAN OTC DRUG SPF Rx - SPF 30 Mango Lip Balm Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LIPSTICK TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part352 Cal Pharma LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 55628-9575_22e594bf-45cb-498f-a9de-9a7b986757a9 55628-9575 HUMAN OTC DRUG SPF Rx - SPF 15 Spearmint Lip Balm Octinoxate, Octisalate, Avobenzone, Octocrylene LIPSTICK TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part352 Cal Pharma LLC OCTINOXATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 6.5; 5; 2; 1.5 g/100g; g/100g; g/100g; g/100g N 20181231 55628-9585_d92ed423-9983-4b6c-8f4a-01b1febb2043 55628-9585 HUMAN OTC DRUG SPF Rx - SPF 50 Spearmint Lip Balm Octinoxate, Zinc LIPSTICK TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part352 Cal Pharma LLC ZINC; OCTINOXATE 19; 7.5 g/100g; g/100g N 20181231 55636-590_4ae9e446-dfbe-4163-9a8b-7d75c1f501f4 55636-590 HUMAN OTC DRUG Promescent Lidicaine SPRAY TOPICAL 20130111 OTC MONOGRAPH FINAL part348 Absorption LIDOCAINE 10 g/100g E 20171231 55648-101_572fcaa4-314e-42b2-aa6b-f5ec54da6199 55648-101 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120830 ANDA ANDA201331 Wockhardt Limited BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 55648-102_e0163d85-d240-4908-8b50-c7f76ba704e7 55648-102 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121121 ANDA ANDA202189 Wockhardt Limited BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 55648-105_572fcaa4-314e-42b2-aa6b-f5ec54da6199 55648-105 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120830 ANDA ANDA201331 Wockhardt Limited BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 55648-107_572fcaa4-314e-42b2-aa6b-f5ec54da6199 55648-107 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120830 ANDA ANDA201331 Wockhardt Limited BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 55648-140_f93c2a1e-e11b-4b97-a282-29d0dbb1b8c9 55648-140 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202727 Wockhardt Limited LANSOPRAZOLE 15 mg/1 E 20171231 55648-152_88df95c2-5088-4980-9d78-2d1760033ba7 55648-152 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20100524 ANDA ANDA090216 Wockhardt Limited VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55648-153_88df95c2-5088-4980-9d78-2d1760033ba7 55648-153 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20100524 ANDA ANDA090216 Wockhardt Limited VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55648-154_04e661d1-6156-43d0-abbd-64be8eca1666 55648-154 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55648-155_04e661d1-6156-43d0-abbd-64be8eca1666 55648-155 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55648-171_04e661d1-6156-43d0-abbd-64be8eca1666 55648-171 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55648-172_04e661d1-6156-43d0-abbd-64be8eca1666 55648-172 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55648-174_04e661d1-6156-43d0-abbd-64be8eca1666 55648-174 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55648-175_04e661d1-6156-43d0-abbd-64be8eca1666 55648-175 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55648-177_04e661d1-6156-43d0-abbd-64be8eca1666 55648-177 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55648-185_e385374d-41df-4e59-a74d-6dad0d7dacee 55648-185 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20130302 ANDA ANDA203070 Wockhardt Limited ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 55648-186_efd91c83-22ed-4ef6-a09c-dfa0a1f4889b 55648-186 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION INTRAVENOUS 20130302 ANDA ANDA203069 Wockhardt Limited ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 55648-215_13a19063-0185-47a3-8153-199fc69d73a8 55648-215 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20120815 ANDA ANDA201948 Wockhardt Limited DICLOFENAC SODIUM; MISOPROSTOL 50; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 55648-217_13a19063-0185-47a3-8153-199fc69d73a8 55648-217 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20120815 ANDA ANDA201948 Wockhardt Limited DICLOFENAC SODIUM; MISOPROSTOL 75; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 55648-271_ddc5823c-ca8f-4f63-9d7b-d54c82798452 55648-271 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55648-272_ddc5823c-ca8f-4f63-9d7b-d54c82798452 55648-272 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55648-273_ddc5823c-ca8f-4f63-9d7b-d54c82798452 55648-273 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55648-274_ddc5823c-ca8f-4f63-9d7b-d54c82798452 55648-274 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt Limited LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55648-275_ddc5823c-ca8f-4f63-9d7b-d54c82798452 55648-275 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt Limited LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55648-290_ec3c430e-e3b9-4871-91d0-77d58a020431 55648-290 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120930 NDA AUTHORIZED GENERIC NDA020796 Wockhardt Limited ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] E 20171231 55648-311_63aed8fa-52e1-4e47-91ed-cb7fd6b8cce0 55648-311 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA091267 Wockhardt Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 55648-312_63aed8fa-52e1-4e47-91ed-cb7fd6b8cce0 55648-312 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA091267 Wockhardt Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 55648-314_79a0b285-80de-4b38-9d3f-37fb165ef36b 55648-314 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120522 ANDA ANDA202266 Wockhardt Limited CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 55648-315_79a0b285-80de-4b38-9d3f-37fb165ef36b 55648-315 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20121113 ANDA ANDA202266 Wockhardt Limited CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 55648-374_d0e9c888-c641-40a8-9338-d83b6de02385 55648-374 HUMAN OTC DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20100806 ANDA ANDA090837 WOCKHARDT LIMITED FAMOTIDINE 20 mg/1 E 20171231 55648-411_a0bf854d-54eb-42f1-891b-3facd48042f0 55648-411 HUMAN PRESCRIPTION DRUG FELODIPINE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101205 ANDA ANDA091484 WOCKHARDT LIMITED FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55648-412_a0bf854d-54eb-42f1-891b-3facd48042f0 55648-412 HUMAN PRESCRIPTION DRUG FELODIPINE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101205 ANDA ANDA091484 WOCKHARDT LIMITED FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55648-414_a0bf854d-54eb-42f1-891b-3facd48042f0 55648-414 HUMAN PRESCRIPTION DRUG FELODIPINE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101205 ANDA ANDA091484 WOCKHARDT LIMITED FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55648-421_bc38c309-978f-47ec-9357-aa73b81f9c39 55648-421 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070906 ANDA ANDA078500 WOCKHARDT LIMITED AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55648-422_bc38c309-978f-47ec-9357-aa73b81f9c39 55648-422 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070906 ANDA ANDA078500 WOCKHARDT LIMITED AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55648-423_bc38c309-978f-47ec-9357-aa73b81f9c39 55648-423 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070906 ANDA ANDA078500 WOCKHARDT LIMITED AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55648-433_ff0dc161-4748-415c-ba20-bdfff819c611 55648-433 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 WOCKHARDT LIMITED PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55648-434_ff0dc161-4748-415c-ba20-bdfff819c611 55648-434 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 WOCKHARDT LIMITED PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55648-447_fda4671d-cce2-44b4-b41c-caa6ca7ecbec 55648-447 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE TABLET ORAL 20091211 ANDA ANDA078701 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55648-516_dde247ce-2fbe-4071-9af7-446d65376ec2 55648-516 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 WOCKHARDT LIMITED TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 55648-544_48b9f69b-8df6-40da-b1ff-ba2965853fe8 55648-544 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Wockhardt Limited LEVOFLOXACIN 250 mg/1 N 20181231 55648-545_48b9f69b-8df6-40da-b1ff-ba2965853fe8 55648-545 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Wockhardt Limited LEVOFLOXACIN 500 mg/1 N 20181231 55648-547_48b9f69b-8df6-40da-b1ff-ba2965853fe8 55648-547 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Wockhardt Limited LEVOFLOXACIN 750 mg/1 N 20181231 55648-553_aaa62d0c-37d5-40a9-8940-2f2b7397197f 55648-553 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT LIMITED RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 55648-554_aaa62d0c-37d5-40a9-8940-2f2b7397197f 55648-554 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT LIMITED RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 55648-555_aaa62d0c-37d5-40a9-8940-2f2b7397197f 55648-555 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT LIMITED RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 55648-557_aaa62d0c-37d5-40a9-8940-2f2b7397197f 55648-557 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT LIMITED RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 55648-571_aaa62d0c-37d5-40a9-8940-2f2b7397197f 55648-571 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT LIMITED RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 55648-572_aaa62d0c-37d5-40a9-8940-2f2b7397197f 55648-572 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 WOCKHARDT LIMITED RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 55648-630_2003e556-60bd-4127-ab47-324acb610460 55648-630 HUMAN PRESCRIPTION DRUG ADENOSINE ADENOSINE INJECTION INTRAVENOUS 20130330 ANDA ANDA079147 Wockhardt Limited ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 55648-630_f0ace3f7-9353-4709-a5a5-ea7686286a67 55648-630 HUMAN PRESCRIPTION DRUG ADENOSINE ADENOSINE INJECTION INTRAVENOUS 20090720 ANDA ANDA090220 WOCKHARDT LIMITED ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 55648-631_1aa072e3-8f11-4e34-8d13-bc0021f33713 55648-631 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20091109 ANDA ANDA090671 Wockhardt Limited NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55648-632_3612a4d7-791d-4f11-aab1-4aefb5203bf1 55648-632 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090986 Wockhardt Limited OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 55648-633_3612a4d7-791d-4f11-aab1-4aefb5203bf1 55648-633 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090985 Wockhardt Limited OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 55648-634_3612a4d7-791d-4f11-aab1-4aefb5203bf1 55648-634 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090986 Wockhardt Limited OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 55648-635_3612a4d7-791d-4f11-aab1-4aefb5203bf1 55648-635 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090985 Wockhardt Limited OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 55648-636_3612a4d7-791d-4f11-aab1-4aefb5203bf1 55648-636 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090985 Wockhardt Limited OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 55648-661_dae3e3e8-5de8-412f-9b98-6443c9d2edc0 55648-661 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080630 ANDA ANDA078564 WOCKHARDT LIMITED GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55648-661_e6ecd37b-72e8-48e2-b8ec-d4637c4d44a3 55648-661 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080630 ANDA ANDA078565 WOCKHARDT LIMITED GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55648-662_ac38ecc1-4f9d-4c72-88d5-c3caf3bf2b51 55648-662 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080303 ANDA ANDA078566 WOCKHARDT LIMITED GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55648-669_ad574d8c-de35-45d3-8cdb-4f56e18ec0d9 55648-669 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120810 ANDA ANDA202176 Wockhardt Limited LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 55648-670_ad574d8c-de35-45d3-8cdb-4f56e18ec0d9 55648-670 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120810 ANDA ANDA202176 Wockhardt Limited LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 55648-692_a0cd87aa-d540-4d98-800a-15b909dbbee3 55648-692 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE SOLUTION ORAL 20091014 ANDA ANDA078744 WOCKHARDT LIMITED RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] E 20171231 55648-694_d2bbcbe8-36ec-4631-8469-7d1911797403 55648-694 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE SYRUP ORAL 20090526 ANDA ANDA079211 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 55648-701_37b1b0c4-49ec-4650-a5df-1b448ff26e87 55648-701 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Wockhardt Limited CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55648-702_37b1b0c4-49ec-4650-a5df-1b448ff26e87 55648-702 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Wockhardt Limited CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55648-703_37b1b0c4-49ec-4650-a5df-1b448ff26e87 55648-703 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Wockhardt Limited CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55648-711_419accad-98ef-4290-ba9c-be6a387a0202 55648-711 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120816 ANDA ANDA078941 Wockhardt Limited ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 55648-712_ba6f00bd-79a2-46c1-87fa-054b258903ee 55648-712 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET, FILM COATED ORAL 20070615 ANDA ANDA065428 Wockhardt Limited CEFPROZIL 250 mg/1 E 20171231 55648-713_ba6f00bd-79a2-46c1-87fa-054b258903ee 55648-713 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET, FILM COATED ORAL 20070615 ANDA ANDA065428 Wockhardt Limited CEFPROZIL 500 mg/1 E 20171231 55648-714_1818aead-1bb7-45f5-88f2-4278bbccc8fc 55648-714 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET, FILM COATED ORAL 20070515 ANDA ANDA078426 Wockhardt Limited ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 55648-715_1818aead-1bb7-45f5-88f2-4278bbccc8fc 55648-715 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET, FILM COATED ORAL 20070515 ANDA ANDA078426 Wockhardt Limited ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 55648-716_cd51dc6a-6737-49ce-b330-bb8cd16d8542 55648-716 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078865 Wockhardt Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55648-717_cd51dc6a-6737-49ce-b330-bb8cd16d8542 55648-717 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078865 Wockhardt Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55648-718_cd51dc6a-6737-49ce-b330-bb8cd16d8542 55648-718 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078865 Wockhardt Limited VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 55648-720_21c147fd-c3a2-4c0d-b8a0-4370bebc33f0 55648-720 HUMAN PRESCRIPTION DRUG EXTENDED PHENYTOIN SODIUM EXTENDED PHENYTOIN SODIUM CAPSULE ORAL 20080130 ANDA ANDA040732 Wockhardt Limited PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 55648-724_f8aa46d8-270b-48ea-95fc-5febb7b8ddab 55648-724 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM ER DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090210 ANDA ANDA078705 WOCKHARDT LIMITED DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55648-725_f8aa46d8-270b-48ea-95fc-5febb7b8ddab 55648-725 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM ER DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078705 WOCKHARDT LIMITED DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 55648-726_eaf9d55f-60bd-4db7-8919-3e2d7103a4e6 55648-726 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20061227 ANDA ANDA077716 WOCKHARDT LIMITED ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55648-727_eaf9d55f-60bd-4db7-8919-3e2d7103a4e6 55648-727 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20061227 ANDA ANDA077577 WOCKHARDT LIMITED ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55648-728_677214c1-8f46-4345-8dae-8f0bb97154fc 55648-728 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate INJECTION SUBCUTANEOUS 20090206 ANDA ANDA078593 Wockhardt Limited SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 55648-734_47a324a2-9549-4f0e-ba7f-4259338b3f36 55648-734 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt Limited METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55648-735_47a324a2-9549-4f0e-ba7f-4259338b3f36 55648-735 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt Limited METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55648-736_47a324a2-9549-4f0e-ba7f-4259338b3f36 55648-736 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt Limited METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55648-737_47a324a2-9549-4f0e-ba7f-4259338b3f36 55648-737 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt Limited METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 55648-738_684641a9-69ac-47dc-9fc5-3dc6c9b4028c 55648-738 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET ORAL 20120815 ANDA ANDA090221 Wockhardt Limited ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55648-739_e11649f1-cacd-4246-ba5c-c45407d16c93 55648-739 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION INTRAVENOUS 20081030 ANDA ANDA077610 Wockhardt Limited AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 55648-740_f60514be-7bf5-48bb-9a26-e1a70b7e74c1 55648-740 HUMAN OTC DRUG RANITIDINE RANITIDINE TABLET, COATED ORAL 20080731 ANDA ANDA078884 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 55648-741_e0f509b6-6e58-4f2d-8abf-84d4852cf9a2 55648-741 HUMAN OTC DRUG RANITIDINE RANITIDINE TABLET, COATED ORAL 20071126 ANDA ANDA078653 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 55648-742_fda4671d-cce2-44b4-b41c-caa6ca7ecbec 55648-742 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE TABLET ORAL 20091211 ANDA ANDA078701 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 55648-743_dfe33d51-4932-412a-a90f-47007dc507cb 55648-743 HUMAN PRESCRIPTION DRUG TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET ORAL 20070702 ANDA ANDA078229 Wockhardt Limited TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 55648-744_865eb588-6553-4222-b98e-3759fab38f2d 55648-744 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt Limited FEXOFENADINE HYDROCHLORIDE 30 mg/1 N 20181231 55648-757_a12b2b3e-bac4-4cd6-a104-24283bc0f02e 55648-757 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20070327 ANDA ANDA077942 WOCKHARDT LIMITED KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 55648-758_a12b2b3e-bac4-4cd6-a104-24283bc0f02e 55648-758 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20070327 ANDA ANDA077942 WOCKHARDT LIMITED KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 55648-762_78b2a31c-22dd-42f7-8085-c32010d52256 55648-762 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20080530 ANDA ANDA078141 Wockhardt Limited MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55648-763_78b2a31c-22dd-42f7-8085-c32010d52256 55648-763 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20080530 ANDA ANDA078141 Wockhardt Limited MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55648-764_cc33c428-6db9-428c-8f4d-f575f27b60b8 55648-764 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20081110 ANDA ANDA078511 Wockhardt Limited MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55648-765_cc33c428-6db9-428c-8f4d-f575f27b60b8 55648-765 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20081110 ANDA ANDA078511 Wockhardt Limited MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55648-771_62d19008-0fd5-4b90-a910-10bd48ac265a 55648-771 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55648-773_62d19008-0fd5-4b90-a910-10bd48ac265a 55648-773 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55648-774_62d19008-0fd5-4b90-a910-10bd48ac265a 55648-774 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55648-775_62d19008-0fd5-4b90-a910-10bd48ac265a 55648-775 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55648-776_62d19008-0fd5-4b90-a910-10bd48ac265a 55648-776 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt Limited ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55648-780_e11649f1-cacd-4246-ba5c-c45407d16c93 55648-780 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION INTRAVENOUS 20081030 ANDA ANDA077834 Wockhardt Limited AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 55648-781_db131736-7c7c-4f65-b2ee-b3d5f8e76ead 55648-781 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120930 NDA AUTHORIZED GENERIC NDA020796 Wockhardt Limited ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 55648-782_9866a9f3-77fb-43ec-b516-2a4dac01e1cc 55648-782 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt Limited CARBIDOPA; ENTACAPONE; LEVODOPA 12.5; 200; 50 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 55648-783_9866a9f3-77fb-43ec-b516-2a4dac01e1cc 55648-783 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt Limited CARBIDOPA; ENTACAPONE; LEVODOPA 18.75; 200; 75 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 55648-784_9866a9f3-77fb-43ec-b516-2a4dac01e1cc 55648-784 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt Limited CARBIDOPA; ENTACAPONE; LEVODOPA 25; 200; 100 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 55648-785_9866a9f3-77fb-43ec-b516-2a4dac01e1cc 55648-785 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt Limited CARBIDOPA; ENTACAPONE; LEVODOPA 31.25; 200; 125 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 55648-786_9866a9f3-77fb-43ec-b516-2a4dac01e1cc 55648-786 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt Limited CARBIDOPA; ENTACAPONE; LEVODOPA 37.5; 200; 150 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 55648-787_9866a9f3-77fb-43ec-b516-2a4dac01e1cc 55648-787 HUMAN PRESCRIPTION DRUG carbidopa, levodopa and entacapone carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt Limited CARBIDOPA; ENTACAPONE; LEVODOPA 50; 200; 200 mg/1; mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 55648-902_a23c9856-4839-4614-a57a-6ad4491164cf 55648-902 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt Limited CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 55648-903_a23c9856-4839-4614-a57a-6ad4491164cf 55648-903 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt Limited CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 55648-904_a23c9856-4839-4614-a57a-6ad4491164cf 55648-904 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt Limited CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 55648-905_a23c9856-4839-4614-a57a-6ad4491164cf 55648-905 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTORPIL TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt Limited CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 55648-906_fbd61078-7ec6-4081-a730-4de11b7087a7 55648-906 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 19981217 ANDA ANDA075208 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 55648-907_fbd61078-7ec6-4081-a730-4de11b7087a7 55648-907 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 19981217 ANDA ANDA075208 WOCKHARDT LIMITED RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 55648-920_f4bea44f-32ac-431b-8909-e81bb02e65ac 55648-920 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Wockhardt Limited CEFUROXIME AXETIL 125 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55648-921_f4bea44f-32ac-431b-8909-e81bb02e65ac 55648-921 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Wockhardt Limited CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55648-922_f4bea44f-32ac-431b-8909-e81bb02e65ac 55648-922 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Wockhardt Limited CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55648-923_c6ea4a09-66d5-4f33-9f17-9c63cb59e4b5 55648-923 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt Limited ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55648-924_c6ea4a09-66d5-4f33-9f17-9c63cb59e4b5 55648-924 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt Limited ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55648-925_c6ea4a09-66d5-4f33-9f17-9c63cb59e4b5 55648-925 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt Limited ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55648-926_c6ea4a09-66d5-4f33-9f17-9c63cb59e4b5 55648-926 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt Limited ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55648-927_f68b2093-d117-4a59-aa38-83fbe1e48e87 55648-927 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt Limited LISINOPRIL 2.5 mg/1 N 20181231 55648-928_f68b2093-d117-4a59-aa38-83fbe1e48e87 55648-928 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt Limited LISINOPRIL 5 mg/1 N 20181231 55648-929_f68b2093-d117-4a59-aa38-83fbe1e48e87 55648-929 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt Limited LISINOPRIL 10 mg/1 N 20181231 55648-936_b0208b67-58f7-4e87-9dc2-48cb6d9d9790 55648-936 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Wockhardt Limited FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 55648-937_b0208b67-58f7-4e87-9dc2-48cb6d9d9790 55648-937 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Wockhardt Limited FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 55648-941_f68b2093-d117-4a59-aa38-83fbe1e48e87 55648-941 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt Limited LISINOPRIL 20 mg/1 N 20181231 55648-942_f68b2093-d117-4a59-aa38-83fbe1e48e87 55648-942 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt Limited LISINOPRIL 40 mg/1 N 20181231 55648-945_bcc27cd7-e3ac-4ec3-ba94-7bcaaf9bcf10 55648-945 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060727 ANDA ANDA077636 WOCKHARDT LIMITED ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 55648-946_bcc27cd7-e3ac-4ec3-ba94-7bcaaf9bcf10 55648-946 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060727 ANDA ANDA077636 WOCKHARDT LIMITED ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 55648-947_ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b 55648-947 HUMAN PRESCRIPTION DRUG CEFOTAXIME CEFOTAXIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080620 ANDA ANDA065197 WOCKHARDT LIMITED CEFOTAXIME SODIUM 500 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55648-948_ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b 55648-948 HUMAN PRESCRIPTION DRUG CEFOTAXIME CEFOTAXIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080620 ANDA ANDA065197 WOCKHARDT LIMITED CEFOTAXIME SODIUM 2 g/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55648-949_33ad64a4-7952-474e-baad-0c6f7528d06a 55648-949 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Wockhardt Limited CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 55648-953_f68b2093-d117-4a59-aa38-83fbe1e48e87 55648-953 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt Limited LISINOPRIL 30 mg/1 N 20181231 55648-954_33ad64a4-7952-474e-baad-0c6f7528d06a 55648-954 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Wockhardt Limited CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 55648-961_e25928bc-ff72-4b62-b372-c50a7a3b9960 55648-961 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 WOCKHARDT LIMITED AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 55648-962_a83b5bd6-9e8e-4d1b-abc2-d27f28223598 55648-962 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065302 WOCKHARDT LIMITED AZITHROMYCIN ANHYDROUS 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 55648-964_e25928bc-ff72-4b62-b372-c50a7a3b9960 55648-964 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 WOCKHARDT LIMITED AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 55648-965_a3ff540a-0e67-4d4c-ab96-b80b28373771 55648-965 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20030929 ANDA ANDA040532 Wockhardt Limited BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] E 20171231 55648-966_a3ff540a-0e67-4d4c-ab96-b80b28373771 55648-966 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20030929 ANDA ANDA040533 Wockhardt Limited BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] E 20171231 55648-967_a3ff540a-0e67-4d4c-ab96-b80b28373771 55648-967 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20030929 ANDA ANDA040534 Wockhardt Limited BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] E 20171231 55648-968_a3ff540a-0e67-4d4c-ab96-b80b28373771 55648-968 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20030929 ANDA ANDA040518 Wockhardt Limited BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] E 20171231 55648-973_bf372a2f-7f7c-45dc-963c-083c87feb354 55648-973 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20080731 ANDA ANDA077296 WOCKHARDT LIMITED DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55648-974_bf372a2f-7f7c-45dc-963c-083c87feb354 55648-974 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20080731 ANDA ANDA077296 WOCKHARDT LIMITED DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55648-975_bf372a2f-7f7c-45dc-963c-083c87feb354 55648-975 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20080731 ANDA ANDA077296 WOCKHARDT LIMITED DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55648-976_6b9cd601-bdd6-48fa-9988-63abfa1f7e3c 55648-976 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA078038 Wockhardt Limited PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 55648-977_6b9cd601-bdd6-48fa-9988-63abfa1f7e3c 55648-977 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA078038 Wockhardt Limited PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 55648-978_6b9cd601-bdd6-48fa-9988-63abfa1f7e3c 55648-978 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA078038 Wockhardt Limited PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 55648-982_865eb588-6553-4222-b98e-3759fab38f2d 55648-982 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt Limited FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 55648-983_37b1b0c4-49ec-4650-a5df-1b448ff26e87 55648-983 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060512 ANDA ANDA065180 Wockhardt Limited CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55648-986_ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b 55648-986 HUMAN PRESCRIPTION DRUG CEFOTAXIME CEFOTAXIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060829 ANDA ANDA065197 WOCKHARDT LIMITED CEFOTAXIME SODIUM 1 g/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55648-987_865eb588-6553-4222-b98e-3759fab38f2d 55648-987 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt Limited FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 55648-990_bcc27cd7-e3ac-4ec3-ba94-7bcaaf9bcf10 55648-990 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20051222 ANDA ANDA077636 WOCKHARDT LIMITED ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 55648-991_a1ced08e-5f3f-4d84-a39f-507734086ae2 55648-991 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt Limited ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 55648-992_a1ced08e-5f3f-4d84-a39f-507734086ae2 55648-992 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt Limited ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 55648-993_a1ced08e-5f3f-4d84-a39f-507734086ae2 55648-993 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt Limited ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 55648-994_a1ced08e-5f3f-4d84-a39f-507734086ae2 55648-994 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt Limited ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 55651-005_dacfe618-34c9-48a7-a078-0961cbcb3d61 55651-005 HUMAN OTC DRUG Eye Drops Regular Tetrahydrozoline hydrochloride SOLUTION/ DROPS OPHTHALMIC 20030828 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 55651-008_b646c9ae-1151-46da-9a2e-8d11c23cff46 55651-008 HUMAN OTC DRUG Artificial Tears Polyvinyl alcohol, Povidone SOLUTION/ DROPS OPHTHALMIC 20031125 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. POLYVINYL ALCOHOL; POVIDONE 5; 6 mg/mL; mg/mL N 20181231 55651-012_05d1bdb4-1d77-47ef-95e9-e418c9ee2a9b 55651-012 HUMAN OTC DRUG Eye Drops Extra Tetrahydrozoline hydrochloride, Polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20031209 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. TETRAHYDROZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 400 .5; 10 mg/mL; mg/mL N 20181231 55651-024_368dcefa-1617-4e8b-8f03-2f660b2baaa4 55651-024 HUMAN OTC DRUG Eye Drops AC Tetrahydrozoline hydrochloride, Zinc sulfate SOLUTION/ DROPS OPHTHALMIC 20031023 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .5; 2.5 mg/mL; mg/mL N 20181231 55651-025_e647058b-7791-4ca8-861e-895925872480 55651-025 HUMAN OTC DRUG Eye Drops Advanced Relief Tetrahydrozoline hydrochloride, Polyethylene glycol 400, Dextran 70, Povidone SOLUTION/ DROPS OPHTHALMIC 20031209 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. TETRAHYDROZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 400; DEXTRAN 70; POVIDONE .5; 10; 1; 10 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55651-026_584b030c-552a-499d-95b1-9ff4c07fe0d1 55651-026 HUMAN OTC DRUG Eye Drops Lubricating Tears Hypromellose, Glycerin, Polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20080512 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. HYPROMELLOSES; GLYCERIN; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL N 20181231 55651-028_58b372ae-43f2-4aba-8016-da1c7ace8e3f 55651-028 HUMAN OTC DRUG Eye Drops SY Polyethylene glycol 400, Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20100317 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 55651-050_99f482ad-9dea-492b-9f52-b85625215cfe 55651-050 HUMAN OTC DRUG Eye Drops Redness and Dry Eye Relief Naphazoline hydrochloride, Glycerin SOLUTION/ DROPS OPHTHALMIC 20071022 OTC MONOGRAPH FINAL part349 KC Pharmaceuticals, Inc. NAPHAZOLINE HYDROCHLORIDE; GLYCERIN .12; 2 mg/mL; mg/mL N 20181231 55651-264_41e599f4-9fe4-4b38-881d-17302f6e1d7a 55651-264 HUMAN OTC DRUG Pepbis Regular Bismuth subslicylate SUSPENSION ORAL 20040304 OTC MONOGRAPH FINAL part335 KC Pharmaceuticals, Inc. BISMUTH SUBSALICYLATE 17.5 mg/mL N 20181231 55653-0001_2e3614be-e5df-4245-b5cc-540e4a92834c 55653-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19851107 UNAPPROVED MEDICAL GAS Home MediService, Inc. OXYGEN 99 L/100L E 20171231 55655-269_8f49a72f-0c3c-48df-bdaf-037c4ac48c58 55655-269 HUMAN OTC DRUG LIVESTS MOIST FOUNDATION 121 Titanium dioxide LIQUID TOPICAL 20161209 OTC MONOGRAPH NOT FINAL part352 ARSOA HONSHA CORPORATION TITANIUM DIOXIDE 2.31 g/20mL N 20181231 55655-270_e9ae212b-bfee-4662-84fc-a33a1ac79f3b 55655-270 HUMAN OTC DRUG LIVESTS MOIST FOUNDATION 122 Titanium dioxide LIQUID TOPICAL 20161209 OTC MONOGRAPH NOT FINAL part352 ARSOA HONSHA CORPORATION TITANIUM DIOXIDE 2.31 g/20mL N 20181231 55655-271_a205f7c6-4de0-4353-9165-5d59ba43399b 55655-271 HUMAN OTC DRUG LIVESTS MOIST FOUNDATION 123 Titanium dioxide LIQUID TOPICAL 20161209 OTC MONOGRAPH NOT FINAL part352 ARSOA HONSHA CORPORATION TITANIUM DIOXIDE 2.31 g/20mL N 20181231 55662-0117_c9d9232a-31ea-41d5-8355-cec79c6d70bb 55662-0117 HUMAN OTC DRUG HemOral Aesculus hippocastanum, Aloe socotrina, Apis mellifica, Bryonia, Calcarea fluorica, Carbo vegetabilis, Causticum, Collinsonia canadensis, Echinacea angustifolia, Hamamelis virginiana, Lycopodium clavatum, Sulphur LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Alchemed HORSE CHESTNUT; ALOE; APIS MELLIFERA; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; ACTIVATED CHARCOAL; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LYCOPODIUM CLAVATUM SPORE; SULFUR 3; 4; 4; 4; 8; 10; 6; 3; 3; 3; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 55670-040_5e7081d7-f877-b109-e053-2991aa0a07a0 55670-040 HUMAN OTC DRUG Moore Medical Honey Lemon Cough Drops Menthol Cough Drops LOZENGE ORAL 20160201 OTC MONOGRAPH FINAL part341 Moore Medical LLC MENTHOL 8.6 mg/1 N 20181231 55670-046_5e708d49-760b-9b91-e053-2a91aa0a5f36 55670-046 HUMAN OTC DRUG MooreBrand Assorted Cough Drops Menthol Cough Drops LOZENGE ORAL 20160201 OTC MONOGRAPH FINAL part341 Moore Medical LLC MENTHOL 8.6 mg/1 N 20181231 55670-050_0cb25f1b-6f1a-73ed-e054-00144ff88e88 55670-050 HUMAN OTC DRUG Moore Medical Cherry Cough Suppressant/Anesthetic Drops Menthol LOZENGE ORAL 20111101 OTC MONOGRAPH FINAL part341 Moore Medical LLC MENTHOL 7.6 mg/1 N 20181231 55670-060_5e709c05-030f-d8e2-e053-2991aa0affbf 55670-060 HUMAN OTC DRUG Moore Medical Menthol Eucalyptus Cough Drops Menthol Cough Drops LOZENGE ORAL 20160201 OTC MONOGRAPH FINAL part341 Moore Medical LLC MENTHOL 7 mg/1 N 20181231 55670-080_5e83b790-e2a4-4a82-e053-2991aa0a7a69 55670-080 HUMAN OTC DRUG Moore Medical Sugar Free Black Cherry Cough Suppressant/Anesthetic Drops Menthol LOZENGE ORAL 20111101 OTC MONOGRAPH FINAL part341 Moore Medical LLC MENTHOL 5 mg/1 N 20181231 55670-109_3f9f771d-1cf6-31fa-e054-00144ff8d46c 55670-109 HUMAN OTC DRUG Moore Medical Sugar Free Menthol Cough Suppressant/Anesthetic Drops Menthol LOZENGE ORAL 20111101 OTC MONOGRAPH FINAL part341 Moore Medical LLC MENTHOL 5.8 mg/1 N 20181231 55670-112_b18d0cd7-2b0b-4eba-9649-521ebe7ba389 55670-112 HUMAN OTC DRUG Hand Sanitizer alcohol GEL TOPICAL 20120712 OTC MONOGRAPH NOT FINAL part333E Moore Medical LLC ALCOHOL 540.26 g/L N 20181231 55670-122_5e808466-e6f7-7c0b-e053-2991aa0a9142 55670-122 HUMAN OTC DRUG Moore Medical Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Moore Medical LLC ACETAMINOPHEN 325 mg/1 N 20181231 55670-130_4aa166fb-f67d-25ed-e054-00144ff88e88 55670-130 HUMAN OTC DRUG Moore Medical Extra Strength Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Moore Medical LLC ACETAMINOPHEN 500 mg/1 N 20181231 55670-131_10010fb2-524b-7175-e054-00144ff8d46c 55670-131 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part343 Moore Medical LLC ASPIRIN 325 mg/1 N 20181231 55670-141_2dd20f88-5d5c-4db5-8e0b-e0fd717fbc3f 55670-141 HUMAN OTC DRUG Moore Medical Antacid calcium carbonate TABLET, CHEWABLE ORAL 20140711 OTC MONOGRAPH FINAL part331 Moore Medical LLC CALCIUM CARBONATE 420 mg/1 N 20181231 55670-142_4aa0ed0f-b6eb-0388-e054-00144ff8d46c 55670-142 HUMAN OTC DRUG Moore Medical Antacid calcium carbonate TABLET, CHEWABLE ORAL 20081230 OTC MONOGRAPH FINAL part331 Moore Medical LLC CALCIUM CARBONATE 420 mg/1 N 20181231 55670-143_4aa25ba2-48e1-4b56-e054-00144ff8d46c 55670-143 HUMAN OTC DRUG Moore Medical MooreBrand Severe Cold Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Moore Medical LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55670-150_5e82cf94-a68c-3953-e053-2a91aa0a5b6a 55670-150 HUMAN OTC DRUG Moore Medical Sinus Pain and Pressure Relief ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Moore Medical LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 55670-163_5e818e99-6d2b-2ef9-e053-2a91aa0a9fb0 55670-163 HUMAN OTC DRUG MooreBrand Phenylephrine PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH FINAL part341 Moore Medical LLC PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 N 20181231 55670-467_5e80336e-5d28-392f-e053-2a91aa0a82c6 55670-467 HUMAN OTC DRUG Moore Medical Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Moore Medical LLC ACETAMINOPHEN 325 mg/1 N 20181231 55670-468_4aa20f8a-a454-3e28-e054-00144ff8d46c 55670-468 HUMAN OTC DRUG Moore Medical Extra Strength Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20081230 OTC MONOGRAPH NOT FINAL part343 Moore Medical LLC ACETAMINOPHEN 500 mg/1 N 20181231 55670-474_06f94a65-dff2-3b30-e054-00144ff88e88 55670-474 HUMAN OTC DRUG Moore Medical Bismuth BISMUTH SUBSALICYLATE TABLET, CHEWABLE ORAL 20140401 OTC MONOGRAPH FINAL part335 Moore Medical LLC BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 55670-475_5e821558-bbe3-b150-e053-2a91aa0a549e 55670-475 HUMAN OTC DRUG Moore Medical Sinus Pain and Pressure Relief ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20081230 OTC MONOGRAPH FINAL part341 Moore Medical LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 N 20181231 55670-478_429e6ca9-3d24-5595-e054-00144ff88e88 55670-478 HUMAN OTC DRUG Moore Medical Loratadine Loratadine TABLET, FILM COATED ORAL 20081230 ANDA ANDA076134 Moore Medical LLC LORATADINE 10 mg/1 N 20181231 55670-492_5f10a604-22ed-58dd-e053-2991aa0a1aec 55670-492 HUMAN OTC DRUG Bacitracin Antibiotic CREAM TOPICAL 20171116 OTC MONOGRAPH FINAL part333B Moore Medical BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 55670-600_ccad54de-01f8-4c14-a11b-c0f9c7c9fd8f 55670-600 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20120711 OTC MONOGRAPH FINAL part333B Moore Medical LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 55670-601_5e93ed6e-130b-07b3-e053-2a91aa0a7fad 55670-601 HUMAN OTC DRUG Bacitracin bacitracin zinc OINTMENT TOPICAL 20120712 OTC MONOGRAPH FINAL part333B Moore Medical LLC BACITRACIN ZINC 500 [USP'U]/g N 20181231 55670-602_1767e441-9017-480a-b660-e67b2e0e262d 55670-602 HUMAN OTC DRUG Antifungal tolnaftate CREAM TOPICAL 20120716 OTC MONOGRAPH FINAL part333C Moore Medical LLC TOLNAFTATE 10 mg/g N 20181231 55670-710_5f261011-eec4-59fd-e053-2a91aa0a8e54 55670-710 HUMAN OTC DRUG Ammonia Inhalant Ammonia AEROSOL RESPIRATORY (INHALATION) 20171129 UNAPPROVED DRUG OTHER Moore Medical LLC AMMONIA .045 g/.3mL N 20181231 55670-711_d31cbdf1-26a6-4cbe-b0ce-c49aae9b65a2 55670-711 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20110907 OTC MONOGRAPH NOT FINAL part333E Moore Medical LLC BENZALKONIUM CHLORIDE 1.3 mL/L N 20181231 55670-721_2d684510-751b-4fb0-9bf2-42a56c0016e3 55670-721 HUMAN OTC DRUG Moore Brand Alcohol Prep Pads Isopropyl Alcohol SWAB TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part333A Moore Medical LLC ISOPROPYL ALCOHOL 70 g/100g N 20181231 55670-800_047e58dd-0fdf-40bd-a15b-926864e41ab5 55670-800 HUMAN OTC DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20120712 OTC MONOGRAPH NOT FINAL part348 Moore Medical LLC HYDROCORTISONE 10 mg/g N 20181231 55670-803_5d657c30-1906-81cc-e053-2a91aa0a13e7 55670-803 HUMAN OTC DRUG Antiseptic Benzethonium Chloride SOAP TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part333A Moore Medical BENZETHONIUM CHLORIDE .13 mg/mg N 20181231 55670-804_9cc64a11-6c3b-4e1b-bffe-e94c0f1b34ff 55670-804 HUMAN OTC DRUG Antimicrobial Hand TRICLOSAN SOAP TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A Moore Medical LLC TRICLOSAN .375 mL/100mL N 20181231 55670-805_5e7f31ea-5b9a-2f8a-e053-2a91aa0a51b0 55670-805 HUMAN OTC DRUG moorebrand Ibuprofen I buprofen 200 mg TABLET, FILM COATED ORAL 20160201 ANDA ANDA075010 Moore Medical LLC IBUPROFEN 200 mg/1 N 20181231 55670-806_5f104685-bab7-0528-e053-2a91aa0a20e7 55670-806 HUMAN OTC DRUG Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20070601 OTC MONOGRAPH NOT FINAL part333A Moore Medical LLC ALCOHOL 64.5 mL/100mL N 20181231 55670-810_54952d9e-422d-47b9-a05d-c59b2cd4baaa 55670-810 HUMAN OTC DRUG Anesthetic benzocaine GEL TOPICAL 20120712 OTC MONOGRAPH NOT FINAL part356 Moore Medical LLC BENZOCAINE 200 mg/g N 20181231 55670-815_5f2356cc-9642-6217-e053-2991aa0a5db0 55670-815 HUMAN OTC DRUG Moore Brand Unna Boot Zinc Oxide DRESSING TOPICAL 20130306 OTC MONOGRAPH FINAL part347 MOORE MEDICAL LLC ZINC OXIDE 25 g/1 N 20181231 55670-956_5f23de9c-6bb9-a9ce-e053-2991aa0ada53 55670-956 HUMAN OTC DRUG Medicaine Swabs Benzocaine SWAB TOPICAL 20171129 UNAPPROVED DRUG OTHER Moore Medical LLC BENZOCAINE; MENTHOL .12; .006 g/.6mL; g/.6mL N 20181231 55670-957_5f0f860d-727a-af80-e053-2991aa0a434a 55670-957 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333A Moore Medical ISOPROPYL ALCOHOL .7 mL/1 N 20181231 55670-958_5f0f860d-727a-af80-e053-2991aa0a434a 55670-958 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333A Moore Medical ISOPROPYL ALCOHOL .7 mL/1 N 20181231 55670-959_5f0f860d-727a-af80-e053-2991aa0a434a 55670-959 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333A Moore Medical ISOPROPYL ALCOHOL .7 mL/1 N 20181231 55681-211_6109f544-68b8-42b5-b446-acf6fd5d7664 55681-211 HUMAN OTC DRUG procure PETROLATUM OINTMENT TOPICAL 20130205 OTC MONOGRAPH FINAL part347 TWIN MED, LLC PETROLATUM 1 g/g N 20181231 55681-212_96c7a4b4-c858-4800-a1a5-d5380023fcde 55681-212 HUMAN OTC DRUG ProcureVITAMIN A AND D VITAMIN A AND D PETROLATUM OINTMENT TOPICAL 20130205 OTC MONOGRAPH FINAL part347 TWIN MED, LLC PETROLATUM 75 g/100g N 20181231 55681-215_de28a530-cb62-4549-9387-03d0b49e642d 55681-215 HUMAN OTC DRUG PROCURE VITAMIN A AND D Skin Protectant petrolatum OINTMENT TOPICAL 20131206 OTC MONOGRAPH FINAL part347 TWIN MED, LLC PETROLATUM 93.4 g/100g N 20181231 55681-216_2aa35162-15fd-41e6-982d-c6f08aa81fa0 55681-216 HUMAN OTC DRUG ProcureTriple Antibiotic Triple Antibiotic BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B OINTMENT TOPICAL 20130205 OTC MONOGRAPH FINAL part333B TWIN MED, LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 U/g; mg/g; U/g N 20181231 55681-218_84b3894e-361a-431e-bb6e-ddded37420cf 55681-218 HUMAN OTC DRUG procureFirst Aid Antibio First Aid Antibiotic BACITRACIN OINTMENT TOPICAL 20130205 OTC MONOGRAPH FINAL part333B TWIN MED, LLC BACITRACIN ZINC 500 U/g N 20181231 55681-224_cd749ed0-81e5-4246-aa6d-89336b089bda 55681-224 HUMAN OTC DRUG procure Hydrocortisone Acetate OINTMENT TOPICAL 20130205 OTC MONOGRAPH NOT FINAL part348 TWIN MED, LLC HYDROCORTISONE ACETATE 1 g/100g N 20181231 55692-010_0666109a-3483-4f17-b618-449ef388350e 55692-010 HUMAN OTC DRUG BAROX WHITE GOLF Niacinamide CREAM TOPICAL 20151101 UNAPPROVED DRUG OTHER Barox Co., Ltd. NIACINAMIDE 3.5 g/50mL N 20181231 55692-110_2f36747a-67ff-4b2f-b7af-ed21d9975545 55692-110 HUMAN OTC DRUG BAROX S CAMPHOR (SYNTHETIC), METHYL SALICYLATE, MENTHOL GEL TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part348 Barox Co., Ltd. CAMPHOR (SYNTHETIC); METHYL SALICYLATE; MENTHOL 7.08; 5.52; .96 g/120g; g/120g; g/120g N 20181231 55692-150_cad648ff-32ba-4c11-9360-dd673875e08f 55692-150 HUMAN OTC DRUG BAROX S CAMPHOR (SYNTHETIC), METHYL SALICYLATE, MENTHOL GEL TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part348 Barox Co., Ltd. CAMPHOR (SYNTHETIC); METHYL SALICYLATE; MENTHOL 5.9; 4.6; .8 g/100g; g/100g; g/100g N 20181231 55692-200_50542106-3ade-4597-add5-fa96501bdcd7 55692-200 HUMAN OTC DRUG BAROX Body Care Massage Relax Refresh Revital Menthol GEL TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part348 Barox Co., Ltd. MENTHOL 3 mg/120mL N 20181231 55695-001_2b470952-1f38-741f-e054-00144ff88e88 55695-001 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 Department of State Health Services, Pharmacy Branch AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55695-002_2b821631-0df3-0fb2-e054-00144ff8d46c 55695-002 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101228 ANDA ANDA065246 Department of State Health Services, Pharmacy Branch AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55695-003_2b821631-0df3-0fb2-e054-00144ff8d46c 55695-003 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101217 ANDA ANDA065246 Department of State Health Services, Pharmacy Branch AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55695-004_2e0590da-df44-68ee-e054-00144ff8d46c 55695-004 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063181 Department of State Health Services, Pharmacy Branch MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 55695-005_2dc8a875-7d67-2544-e054-00144ff8d46c 55695-005 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20080815 ANDA ANDA086841 Department of State Health Services, Pharmacy Branch DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 55695-006_2e0577d5-adb9-6c8d-e054-00144ff8d46c 55695-006 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 19960718 NDA AUTHORIZED GENERIC NDA050711 Department of State Health Services, Pharmacy Branch AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55695-007_2dc8a415-421e-01dc-e054-00144ff8d46c 55695-007 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin SOLUTION ORAL 20110621 ANDA ANDA091678 Department of State Health Services, Pharmacy Branch LEVOFLOXACIN 25 mg/mL N 20181231 55695-008_2dc8a875-7d63-2544-e054-00144ff8d46c 55695-008 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 Department of State Health Services, Pharmacy Branch SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 55695-009_2b5fe133-8101-4129-e054-00144ff88e88 55695-009 HUMAN PRESCRIPTION DRUG Zyvox linezolid SUSPENSION ORAL 20000418 NDA NDA021132 Department of State Health Services, Pharmacy Branch LINEZOLID 100 mg/5mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 55695-010_2dcafbab-386d-2716-e054-00144ff8d46c 55695-010 HUMAN PRESCRIPTION DRUG Mycobutin rifabutin CAPSULE ORAL 19921223 NDA NDA050689 Department of State Health Services, Pharmacy Branch RIFABUTIN 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 55695-011_2b5f951e-4b6b-2c1f-e054-00144ff8d46c 55695-011 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 Department of State Health Services, Pharmacy Branch METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 55695-012_2e09c51d-a794-3ca7-e054-00144ff8d46c 55695-012 HUMAN PRESCRIPTION DRUG alendronate sodium alendronate sodium TABLET ORAL 20080804 ANDA ANDA076984 Department of State Health Services, Pharmacy Branch ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 55695-013_2bd7831d-4626-1818-e054-00144ff8d46c 55695-013 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20041221 ANDA ANDA040581 Department of State Health Services, Pharmacy Branch PREDNISONE 2.5 mg/1 N 20181231 55695-014_2bd7831d-4626-1818-e054-00144ff8d46c 55695-014 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Department of State Health Services, Pharmacy Branch PREDNISONE 5 mg/1 N 20181231 55695-015_2bd7c7c4-0fe3-2ee8-e054-00144ff88e88 55695-015 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 Department of State Health Services, Pharmacy Branch PREDNISONE 20 mg/1 N 20181231 55695-016_2b87248b-66e7-70ac-e054-00144ff8d46c 55695-016 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Department of State Health Services, Pharmacy Branch GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55695-017_2b876f1a-499b-0abe-e054-00144ff8d46c 55695-017 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Department of State Health Services, Pharmacy Branch GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55695-018_2b5aef5f-d96f-55e0-e054-00144ff8d46c 55695-018 HUMAN PRESCRIPTION DRUG clarithromycin clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080101 ANDA ANDA065145 Department of State Health Services, Pharmacy Branch CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55695-019_2dcafbab-38a8-2716-e054-00144ff8d46c 55695-019 HUMAN PRESCRIPTION DRUG STROMECTOL ivermectin TABLET ORAL 19961122 NDA NDA050742 Department of State Health Services, Pharmacy Branch IVERMECTIN 3 mg/1 Antiparasitic [EPC],Pediculicide [EPC] N 20181231 55695-020_6179baa4-94e2-4e21-e053-2991aa0ae033 55695-020 HUMAN PRESCRIPTION DRUG COARTEM artemether and lumefantrine TABLET ORAL 20090407 20180228 NDA NDA022268 Department of State Health Services, Pharmacy Branch ARTEMETHER; LUMEFANTRINE 20; 120 mg/1; mg/1 Antimalarial [EPC],Antimalarial [EPC] N 20181231 55695-021_6179baa4-9516-4e21-e053-2991aa0ae033 55695-021 HUMAN PRESCRIPTION DRUG ALBENZA albendazole TABLET, FILM COATED ORAL 19960611 20190930 NDA NDA020666 Department of State Health Services, Pharmacy Branch ALBENDAZOLE 200 mg/1 Antihelminthic [EPC],Cytochrome P450 1A Inducers [MoA] N 20181231 55695-022_2b5b3dae-b407-1e2e-e054-00144ff88e88 55695-022 HUMAN PRESCRIPTION DRUG Paromomycin Sulfate Paromomycin Sulfate CAPSULE ORAL 20091022 ANDA ANDA065173 Department of State Health Services, Pharmacy Branch PAROMOMYCIN SULFATE 250 mg/1 Antiprotozoal [EPC] N 20181231 55695-023_2b867b73-de21-2bc2-e054-00144ff88e88 55695-023 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20061215 NDA AUTHORIZED GENERIC NDA016320 Department of State Health Services, Pharmacy Branch ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] N 20181231 55695-024_2bd7831d-4626-1818-e054-00144ff8d46c 55695-024 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Department of State Health Services, Pharmacy Branch PREDNISONE 10 mg/1 N 20181231 55695-025_2dc8a875-7d67-2544-e054-00144ff8d46c 55695-025 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20080815 ANDA ANDA086842 Department of State Health Services, Pharmacy Branch DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 55695-026_2b5aef5f-d967-55e0-e054-00144ff8d46c 55695-026 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 19950401 ANDA ANDA081319 Department of State Health Services, Pharmacy Branch PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] N 20181231 55695-027_2dcb1a5f-a1db-3686-e054-00144ff88e88 55695-027 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080936 Department of State Health Services, Pharmacy Branch ISONIAZID 100 mg/1 Antimycobacterial [EPC] N 20181231 55695-028_2dc8a875-7d68-2544-e054-00144ff8d46c 55695-028 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065153 Department of State Health Services, Pharmacy Branch AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55695-029_2e0577d5-adb9-6c8d-e054-00144ff8d46c 55695-029 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19951019 NDA AUTHORIZED GENERIC NDA050710 Department of State Health Services, Pharmacy Branch AZITHROMYCIN DIHYDRATE 900 mg/22.5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55695-031_2dcb1a5f-a1dd-3686-e054-00144ff88e88 55695-031 HUMAN PRESCRIPTION DRUG Isoniazid isoniazid SOLUTION ORAL 19831111 ANDA ANDA088235 Department of State Health Services, Pharmacy Branch ISONIAZID 50 mg/5mL Antimycobacterial [EPC] N 20181231 55695-032_2b5a2794-49ce-6a30-e054-00144ff88e88 55695-032 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19860710 ANDA ANDA062677 Department of State Health Services, Pharmacy Branch DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 55695-033_2dcb1a5f-a1db-3686-e054-00144ff88e88 55695-033 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 Department of State Health Services, Pharmacy Branch ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 55695-034_2bd7ddd8-9f39-1e14-e054-00144ff8d46c 55695-034 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20010701 ANDA ANDA065028 Department of State Health Services, Pharmacy Branch RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 55695-035_2b867b73-de21-2bc2-e054-00144ff88e88 55695-035 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20061215 NDA AUTHORIZED GENERIC NDA016320 Department of State Health Services, Pharmacy Branch ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] N 20181231 55695-036_2bd7ddd8-9f39-1e14-e054-00144ff8d46c 55695-036 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20010701 ANDA ANDA065028 Department of State Health Services, Pharmacy Branch RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 55700-001_a60a910d-2c4a-4ac7-a314-a2e847f31969 55700-001 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Lake Erie Medical DBA Quality Care Products LLC BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 55700-002_55b224e9-94d4-4fe6-ad40-b78748d729ca 55700-002 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20100804 ANDA ANDA090027 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-003_4455a725-3679-4253-92fe-e3c37aded6f4 55700-003 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20080801 ANDA ANDA076017 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 55700-004_bc097f7f-6959-457c-a147-c2f2d38d53f9 55700-004 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55700-006_7aee951c-887a-4f7f-b2e0-b031aa385ea5 55700-006 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20090702 ANDA ANDA040907 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55700-007_778c8440-82c5-4930-92c5-4299a9d3b497 55700-007 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-008_9d0fb2f0-6f01-4775-a976-0c62de8c60ef 55700-008 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 55700-009_44def686-08ea-4eea-a4e0-f8c9566d643e 55700-009 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55700-010_413b4230-2b63-4949-8c54-c428b60d3652 55700-010 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 55700-011_4c852321-3758-4345-96e3-b09553fcddca 55700-011 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55700-012_4c852321-3758-4345-96e3-b09553fcddca 55700-012 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55700-013_259f804d-2913-46c8-bb58-843374ab54bc 55700-013 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Lake Erie Medical DBA Quality Care Products LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-014_6e252a5b-64b5-4386-b3e3-25f5bd6fd77f 55700-014 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55700-015_443f6afc-f678-4144-a5c1-b6dc7364f454 55700-015 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55700-016_c65f70eb-4bd1-4ccc-969d-a49273755cca 55700-016 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111212 ANDA ANDA201384 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 55700-017_1ec8ada3-4661-43fa-925c-5de4c169285a 55700-017 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20130618 ANDA ANDA078040 Lake Erie Medical DBA Quality Care Products LLC RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 55700-018_c5326aa6-d5cb-43bd-abdc-eae1a7ffb306 55700-018 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20091223 NDA NDA021515 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 55700-019_ee492778-396d-4f3a-81c7-cf31112081ff 55700-019 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20130410 ANDA ANDA090970 Lake Erie Medical DBA Quality Care Products LLC PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55700-020_bb02ad49-3818-46fa-bf24-17872f5f0d8f 55700-020 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20121119 ANDA ANDA090659 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-021_1a57d6e7-5e1d-4fe9-82fc-f3bdc289a621 55700-021 HUMAN PRESCRIPTION DRUG SIMVASTATIN Simvastatin TABLET, FILM COATED ORAL 20120329 ANDA ANDA077752 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55700-022_74baa079-9c50-461e-829f-e69489ff20a0 55700-022 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031101 ANDA ANDA076467 Lake Erie Medical DBA Quality Care Products LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55700-023_6e252a5b-64b5-4386-b3e3-25f5bd6fd77f 55700-023 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55700-024_5944a0e0-6488-4d76-977e-1147d5bdde09 55700-024 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130830 ANDA ANDA090700 Lake Erie Medical DBA Quality Care Products LLC VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55700-025_e86f0dc5-3e25-46c1-afc6-d55dec26b215 55700-025 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine PATCH CUTANEOUS 20130915 ANDA ANDA200675 Lake Erie Medical DBA Quality Care Products LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 55700-027_d863ed6e-d3e9-47e0-b29b-6c9958a87815 55700-027 HUMAN PRESCRIPTION DRUG Clonidine clonidine PATCH TRANSDERMAL 20130208 ANDA ANDA076166 Lake Erie Medical DBA Quality Care Products LLC CLONIDINE .2 mg/d Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 55700-028_eeb6e648-c659-4bc3-abef-ae6a157d893c 55700-028 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 55700-029_22a09cf6-238e-4e8a-ab74-2d60fecd6d9d 55700-029 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20130927 ANDA ANDA201384 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 55700-031_d07dba90-c277-472d-b512-acaf0bf21f8e 55700-031 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Lake Erie Medical DBA Quality Care Products LLC FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] E 20171231 55700-034_eb01e3d7-1c51-45d4-a205-6c176bbc83ef 55700-034 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Lake Erie Medical DBA Quality Care Products LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55700-035_f0c6c86e-57a9-426d-afd8-6ff02045d026 55700-035 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Lake Erie Medical DBA Quality Care Products LLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 55700-037_9f5739f5-a449-4fdf-b6ac-7b627b1897ed 55700-037 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Lake Erie Medical DBA Quality Care Produts LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55700-040_ee968a1a-c44d-4378-a593-f324512fb7f6 55700-040 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Lake Erie Medical DBA Quality Care Products LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-041_e47cb1cf-2415-48b2-8638-1d1325c0df31 55700-041 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120418 NDA NDA021574 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 55700-042_59579c7c-8ad9-43d2-9b9d-5a1b96c8d061 55700-042 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 55700-043_7c28fa42-9a56-41f7-a2fd-071939b29d53 55700-043 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55700-044_aad34606-173c-42c2-9e02-6555cd21dec6 55700-044 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 Lake Erie Medical DBA Quality Care Products LLC PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-045_c643c365-79ca-4b40-811e-22b7ecffa782 55700-045 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Lake Erie Medical DBA Quality Care Products LLC VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55700-046_1fc41617-435f-43d2-904e-44261f430832 55700-046 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20131115 NDA NDA021153 Lake Erie Medical DBA Quality Care Products LLC ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55700-048_697d7fb0-c725-418c-a326-1d9d2aced1d0 55700-048 HUMAN OTC DRUG Terocin Lidocaine, Menthol PATCH TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical DBA Quality Care Products LLC LIDOCAINE; MENTHOL 600; 600 mg/1; mg/1 N 20181231 55700-049_ef726ea4-4c67-4f76-b764-c9a322ce37e3 55700-049 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Lake Erie Medical DBA Quality Care Products LLC PREDNISONE 5 mg/1 N 20181231 55700-051_88938470-722b-4e44-b2b1-bf37ae66c4d7 55700-051 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA076941 Lake Erie Medical DBA Quality Care Products LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 55700-052_650cdf43-0fd5-49ba-bf3b-b9a0ffb7b1c3 55700-052 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19890228 ANDA ANDA072575 Lake Erie Medical DBA Quality Care Products LLC PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55700-053_4c593dde-bf76-4a76-870f-ddc336e7ab5b 55700-053 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071207 Lake Erie Medical DBA Quality Care Products LLC HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] E 20171231 55700-056_16426b25-7375-44fd-8b81-a707b358477f 55700-056 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20121130 ANDA ANDA200295 Lake Erie Medical DBA Quality Care Products LLC LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 55700-057_ae91bcbd-a2d3-4e6c-8696-3d449fd10bb0 55700-057 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20000425 ANDA ANDA075074 Lake Erie Medical DBA Quality Care Products LLC ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-058_7627e1b1-9f91-4371-a03c-c8bcc33cffad 55700-058 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071307 Lake Erie Medical DBA Quality Care Products LLC DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55700-059_ba69ac77-1907-464b-a8ee-2c067897a347 55700-059 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA090528 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55700-061_2962d4d1-9d81-4052-8fee-75dcd39fa0cf 55700-061 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20010605 ANDA ANDA075502 Lake Erie Medical DBA Quality Care Products LLC CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55700-064_cdbf69a3-d5f4-4b96-bd16-53a491c0c4b4 55700-064 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55700-065_0b7c0925-0dba-403f-8f1e-a2fd97c0f9b0 55700-065 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 Lake Erie Medical DBA Quality Care Products LLC AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55700-066_b57d4048-2725-43ce-8456-ea55825a9d2c 55700-066 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20080701 ANDA ANDA076407 Lake Erie Medical DBA Quality Care Products LLC OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55700-067_29471126-11e0-4153-a296-33f4051293f9 55700-067 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Lake Erie Medical DBA Quality Care Products LLC TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55700-068_11978286-28ae-4c10-a6f4-09164cd4555c 55700-068 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 Lake Erie Medical DBA Quality Care Products LLC SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 55700-069_ff528ab5-985e-493c-b59f-e530fba2b01f 55700-069 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20050923 ANDA ANDA065170 Lake Erie Medical DBA Quality Care Products LLC MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 55700-072_698183b9-62cd-4527-9640-faad92ceb96a 55700-072 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 Lake Erie Medical DBA Quality Care Products LLC PREDNISONE 20 mg/1 N 20181231 55700-073_858b13ac-5575-48a2-995e-fcb8db601361 55700-073 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-074_c36fa02d-2aa4-4f55-8343-f13e0b9a6318 55700-074 HUMAN PRESCRIPTION DRUG Ofloxacin ofloxacin SOLUTION AURICULAR (OTIC) 20080331 ANDA ANDA078222 Lake Erie Medical DBA Quality Care Products LLC OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 55700-075_3b69604a-95b0-4446-8ca4-9626741b065e 55700-075 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20180202 ANDA ANDA065291 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 55700-076_99f1b18b-80fc-437d-b925-23bfc8b598c4 55700-076 HUMAN PRESCRIPTION DRUG SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE CAPSULE ORAL 19970715 ANDA ANDA075321 Lake Erie Medical DBA Quality Care Products LLC SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 55700-077_ba69ac77-1907-464b-a8ee-2c067897a347 55700-077 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20140102 ANDA ANDA090528 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55700-079_ae72dc41-5548-49ea-90ab-6f7c96f180d3 55700-079 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Lake Erie Medical DBA Quality Care Products LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-080_6351e19b-3698-4667-b26d-8f251c591154 55700-080 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Lake Erie Medical DBA Quality Care Products LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-082_4a3fe727-2932-48f9-9370-6c2b6710fa62 55700-082 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20140110 ANDA ANDA078040 Lake Erie Medical DBA Quality Care Products LLC RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 55700-083_9fb2c5aa-ffca-43e2-8129-665318748036 55700-083 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-084_5faa6895-8371-4a70-972c-a89ee3c3bf8b 55700-084 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Lake Erie Medical DBA Quality Care Products LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 55700-085_7364518c-0975-49f0-8604-2e0bc95def0c 55700-085 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Lake Erie Medical DBA Quality Care Products LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 55700-086_f99425ef-0971-412c-abf1-b9b8d9bbcc0e 55700-086 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20120105 ANDA ANDA091605 Lake Erie Medical DBA Quality Care Products LLC DOXYCYCLINE 50 mg/1 N 20181231 55700-089_da415c3f-f0ee-47d6-a348-502f73fedcd4 55700-089 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Lake Erie Medical DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-090_2b470407-e6cc-433d-a644-bf6a965b68d6 55700-090 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 Lake Erie Medical DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-091_10a59954-e50c-4cd7-acb8-f02ac3341663 55700-091 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 Lake Erie Medical DBA Quality Care Products LLC NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 55700-092_7bd2e76b-500f-4493-8480-2561c42a7b10 55700-092 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA078295 Lake Erie Medical DBA Quality Care Products LLC SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 55700-093_091512f3-1e58-4f3f-b0cb-fc5dc122ac6b 55700-093 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA078295 Lake Erie Medical DBA Quality Care Products LLC SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 55700-094_2b470407-e6cc-433d-a644-bf6a965b68d6 55700-094 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 Lake Erie Medical DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-096_a4f4fad5-6dfe-41ef-b426-b6c96d3d8c3f 55700-096 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20120515 ANDA ANDA202418 Lake Erie Medical DBA Quality Care Products LLC LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 55700-097_011a4ac1-e226-4350-a706-578dcc7dbdff 55700-097 HUMAN OTC DRUG Loratadine Allergy Relief Loratadine TABLET ORAL 20030828 ANDA ANDA076134 Lake Erie Medical DBA Quality Care Products LLC LORATADINE 10 mg/1 N 20181231 55700-100_26e0f636-354f-4bea-8066-b18bfe48cc6d 55700-100 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA076008 Lake Erie Medical DBA Quality Care Products LLC BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 55700-102_9fb2c5aa-ffca-43e2-8129-665318748036 55700-102 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-105_23db38ba-3ee7-4f61-ae77-245f5a8e2314 55700-105 HUMAN PRESCRIPTION DRUG POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate SOLUTION/ DROPS OPHTHALMIC 19970429 NDA AUTHORIZED GENERIC NDA050567 Lake Erie Medical DBA Quality Care Products LLC POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 55700-109_b32480df-9063-46be-b265-a9112cd38c2f 55700-109 HUMAN PRESCRIPTION DRUG Alprazolam XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA AUTHORIZED GENERIC NDA021434 Lake Erie Medical DBA Quality Care Products LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55700-113_ae6878af-68f9-493c-a246-8d1a56766ad1 55700-113 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20080320 ANDA ANDA077689 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55700-114_a2d62fd0-ecaa-4be3-9b85-c4dda5be7736 55700-114 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Lake Erie Medical DBA Quality Care Products LLC ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 55700-117_06d4b976-272e-4598-ab17-d3aa21470cc4 55700-117 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Lake Erie Medical DBA Quality Care Products LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 55700-118_02f6f648-0a1e-4e79-8071-dfc84e931596 55700-118 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 Lake Erie Medical DBA Quality Care Products LLC PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55700-121_6dcd3556-f602-46be-bc70-6cd02b1a911e 55700-121 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130311 ANDA ANDA078703 Lake Erie Medical DBA Quality Care Products LLC PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-122_0da8c228-980d-4587-9dcf-4db6195e5399 55700-122 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20120105 ANDA ANDA091605 Lake Erie Medical DBA Quality Care Products LLC DOXYCYCLINE 100 mg/1 N 20181231 55700-123_77df121c-2754-431f-b730-eec91a7c51b9 55700-123 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Lake Erie Medical DBA Quality Care Products LLC ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 55700-124_2a0f276d-0ea7-42b3-b6bd-ae3b0a62f299 55700-124 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 55700-127_bc1e70bb-e79f-4eae-8ca6-d55cfb7fbbc2 55700-127 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-128_dfdf8466-a947-4b93-935f-8c81a5b94ce5 55700-128 HUMAN OTC DRUG Senna-Lax SENNOSIDES A AND B TABLET, FILM COATED ORAL 20110504 OTC MONOGRAPH NOT FINAL part334 Lake Erie Medical DBA Quality Care Products LLC SENNOSIDES A AND B 8.6 mg/1 N 20181231 55700-129_9c42534f-fdb3-4039-8914-7903e0b527f1 55700-129 HUMAN PRESCRIPTION DRUG Butalbital, aspirin, and caffeine Butalbital, aspirin, and caffeine CAPSULE ORAL 19851011 ANDA ANDA086996 Lake Erie Medical DBA Quality Care Products LLC BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 55700-132_b3af06bb-a483-4b63-b45a-0139222c690b 55700-132 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 Lake Erie Medical DBA Quality Care Products LLC ESZOPICLONE 1 mg/1 CIV N 20181231 55700-133_b3af06bb-a483-4b63-b45a-0139222c690b 55700-133 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 Lake Erie Medical DBA Quality Care Products LLC ESZOPICLONE 2 mg/1 CIV N 20181231 55700-135_b7027558-a521-48a5-a98d-f3328fa6efdf 55700-135 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 Lake Erie Medical DBA Quality Care Products LLC ESZOPICLONE 3 mg/1 CIV N 20181231 55700-139_9ad64009-74ab-4129-a739-cf0dc55318bf 55700-139 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100604 ANDA ANDA040756 Lake Erie Medical DBA Quality Care Products LLC FOLIC ACID 1 mg/1 E 20171231 55700-141_079abf6b-2273-43f6-a932-79bf6302ce0c 55700-141 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072234 Lake Erie Medical DBA Quality Care Products LLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 55700-142_658139b8-c8d5-4035-aaac-9df781677887 55700-142 HUMAN PRESCRIPTION DRUG Lidocaine lidocaine PATCH CUTANEOUS 20140502 NDA AUTHORIZED GENERIC NDA020612 Lake Erie Medical DBA Quality Care Products LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 55700-144_125a3a5e-55fa-4c5a-996d-55a70ef3fa73 55700-144 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lake Erie Medical DBA Quality Care Products LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 55700-147_2904a2ad-4dc9-44c8-934e-39d97f23a116 55700-147 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine hydrochloride, naloxone hydrochloride FILM, SOLUBLE SUBLINGUAL 20100913 NDA NDA022410 Lake Erie Medical DBA Quality Care Products LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 55700-148_0fd5b96c-175d-4bd3-ac4e-56f70a7443ec 55700-148 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Lake Erie Medical DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-149_41b36369-c6e2-4455-a097-cd84d85f1909 55700-149 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20060111 ANDA ANDA065234 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55700-151_c0b9c729-6060-4378-932b-bbc721d7d2ea 55700-151 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 Lake Erie Medical DBA Quality Caer Products LLC ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55700-152_c23e3d54-ef0d-495d-bd94-114c284a7394 55700-152 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110101 ANDA ANDA077836 Lake Erie Medical DBA Quality Care Products LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 55700-155_11778ffd-fafb-47b0-a747-a523e4cb53f3 55700-155 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Lake Erie Medical DBA Quality Care Products LLC CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 55700-156_10891194-2769-4535-9d43-1b67cefeee00 55700-156 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120328 ANDA ANDA201190 Lake Erie Medical DBA Quality Care Products LLC QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 55700-157_960d3aa0-ebac-421b-b01f-07ad58d3cf57 55700-157 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Lake Erie Medical DBA Quality Care Products LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-158_1b2d80d1-df4c-43de-9e74-d240553a6e59 55700-158 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 55700-160_597a1d52-99d1-4e46-8a40-95af6ff9fe53 55700-160 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Lake Erie Medical DBA Quality Care Products LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-163_64e55f9c-fa9e-42cb-aca7-50accaefbb99 55700-163 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-165_daaede7b-c3e2-421d-8ea3-e452f5c58b99 55700-165 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Lake Erie Medical DBA Quality Care Products LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-167_40dd9a42-ea48-4c49-8770-ba5d3878a989 55700-167 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120222 ANDA ANDA090796 Lake Erie Medical DBA Quality Care Products LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-168_40dd9a42-ea48-4c49-8770-ba5d3878a989 55700-168 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120222 ANDA ANDA090796 Lake Erie Medical DBA Quality Care Products LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-170_ffe177e3-4853-4ad3-bb43-4a5b6adb65ae 55700-170 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 55700-171_19444664-5a75-49d8-a773-861fa17f2883 55700-171 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107 ANDA ANDA065434 Lake Erie Medical DBA Quality Care Products LLC CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55700-172_b3af06bb-a483-4b63-b45a-0139222c690b 55700-172 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 Lake Erie Medical DBA Quality Care Products LLC ESZOPICLONE 3 mg/1 CIV E 20171231 55700-173_cf4aee6d-1f3f-4cbe-9cd6-03c534804fb0 55700-173 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20080317 ANDA ANDA076128 Lake Erie Medical DBA Quality Care Products LLC OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 55700-174_6a415cb5-272b-4859-a610-0b3cd6f6acdc 55700-174 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-175_6a415cb5-272b-4859-a610-0b3cd6f6acdc 55700-175 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-176_acd267f3-96cb-462a-8d9f-71e74526279b 55700-176 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 Lake Erie Medical DBA Quality Care Products LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55700-177_c1e255a2-f0a6-469e-8f76-a8faa248943d 55700-177 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Lake Erie Medical DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-180_bf526351-e496-46d9-ae6b-49378ca54102 55700-180 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine TABLET, FILM COATED ORAL 20020130 ANDA ANDA075872 Lake Erie Medical DBA Quality Care Products LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-190_e5c6e4ff-6976-4646-a801-b31da3a42655 55700-190 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20141205 ANDA ANDA077239 Lake Erie Medical DBA Quality Care Products LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 55700-191_01cb895f-0d3f-4fac-8aa2-2a60366fa855 55700-191 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19960916 NDA NDA019129 Lake Erie Medical DBA Quality Care Products LLC TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55700-192_1346368b-0a24-452f-8b7d-6c23836971a6 55700-192 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-193_6aea726e-c3ed-4568-acf4-b8538f7db065 55700-193 HUMAN OTC DRUG MOBISYL TROLAMINE SALICYLATE CREAM TOPICAL 20140919 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical DBA Quality Care Products LLC TROLAMINE SALICYLATE 10 g/100g N 20181231 55700-196_8806af54-8200-4f67-b62a-17076e718fc1 55700-196 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 20180531 NDA AUTHORIZED GENERIC NDA020998 Lake Erie Medical DBA Quality Care Products LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-199_8806af54-8200-4f67-b62a-17076e718fc1 55700-199 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 20180430 NDA AUTHORIZED GENERIC NDA020998 Lake Erie Medical DBA Quality Care Products LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-200_0cea8707-47ed-44f7-916f-1ee4910bb3f1 55700-200 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 Lake Erie Medical DBA Quality Care Products LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55700-201_1d7f4e91-9116-4e15-bd7b-f63cd0f0bb5f 55700-201 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 19990610 ANDA ANDA075191 Lake Erie Medical DBA Quality Care Products LLC PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] E 20171231 55700-203_35b1e39c-4331-4a8c-a4a2-c50630414b08 55700-203 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Lake Erie Medical DBA Quality Care Products LLC PREDNISONE 20 mg/1 N 20181231 55700-204_0410c746-773c-4436-a91c-e4debdc1cdd7 55700-204 HUMAN PRESCRIPTION DRUG Zonisamide zonisamide CAPSULE ORAL 20121022 ANDA ANDA077637 Lake Erie Medical DBA Quality Care Products LLC ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55700-206_dcf4365f-3c3b-453d-ba47-c3907c489807 55700-206 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 19960718 NDA AUTHORIZED GENERIC NDA050711 Lake Erie Medical DBA Quality Care Products LLC AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55700-207_22a2240c-b766-4a0e-8994-d14eed8cdb1d 55700-207 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20091214 ANDA ANDA062881 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-208_35b1e39c-4331-4a8c-a4a2-c50630414b08 55700-208 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Lake Erie Medical DBA Quality Care Products LLC PREDNISONE 10 mg/1 N 20181231 55700-209_35b1e39c-4331-4a8c-a4a2-c50630414b08 55700-209 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Lake Erie Medical DBA Quality Care Products LLC PREDNISONE 5 mg/1 N 20181231 55700-210_850e0fd9-fb44-4795-a75c-7bad155ab1a9 55700-210 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Lake Erie Medical DBA Quality Care Products LLC TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55700-212_b04f9523-dd30-47ed-848b-564a3b78f4db 55700-212 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20040223 ANDA ANDA076704 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-214_22ff1f77-860b-42c7-ab84-e9779fdaba2b 55700-214 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140501 ANDA ANDA065330 Lake Erie Medical DBA Quality Care Products LLC CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55700-215_27c29b07-f2c9-49cb-bbbe-34023c298419 55700-215 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-216_d9377108-02f5-41a6-ab2d-8cea27219cfe 55700-216 HUMAN PRESCRIPTION DRUG Hydrocodone Bitatrate and Acetaminophen Hydrocodone Bitatrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA040148 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 55700-217_84813241-5805-402b-bf94-fe3e442d246f 55700-217 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20150220 ANDA ANDA076343 Lake Erie Medical DBA Quality Care Products LLC TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55700-218_3283ad87-25b7-42de-9753-706a0149dfcf 55700-218 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Lake Erie Medical DBA Quality Care Products LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55700-220_6469db3a-1abc-4fad-b35c-685ec83503d8 55700-220 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 55700-221_f4999f14-9204-46bf-a55f-f25c67ca7c61 55700-221 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET ORAL 20140709 ANDA ANDA040712 Lake Erie Medical DBA Quality Care Products LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 55700-222_82927f00-8ad4-4274-b947-7d5959fbf390 55700-222 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Lake Erie Medical DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-223_4d688e78-868f-4710-bbe1-30be2b9cb111 55700-223 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55700-224_ce89b316-527e-45b3-ab2a-446873118bf1 55700-224 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040746 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 55700-226_b8021a04-043f-4a63-8761-333d3a324213 55700-226 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Lake Erie Medical DBA Quality Care Products LLC TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55700-227_fc778dbb-e520-4aa4-9d67-b4998d640119 55700-227 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Lake Erie Medical DBA Quality Care Products LLC TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55700-228_45861753-9d48-4e58-9dba-5078d217fb71 55700-228 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Lake Erie Medical DBA Quality Care Products LLC TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55700-229_9a95a326-9bd0-491d-bac9-feea9f92bd99 55700-229 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55700-230_ca7e7ec3-532d-493b-b1f1-01cc73b94198 55700-230 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Lake Erie Medical DBA Quality Care Products LLC PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 55700-232_3fc539fd-667f-4edd-aeca-3a8c98575270 55700-232 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-233_6cd3d52a-d36c-47e5-9c3b-dd790fdbaeb0 55700-233 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 750 mg/1 N 20181231 55700-235_13748acd-1a5b-4440-8e8a-a1f506685c3b 55700-235 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Lake Erie Medical DBA Quality Care Products LLC SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 55700-236_c7c765c7-8622-445d-952c-5cd3d2f4e02a 55700-236 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072235 Lake Erie Medical DBA Quality Care Products LLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 55700-237_0d073e11-0ec8-472d-aa98-bfb0c2a90e9a 55700-237 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20140627 ANDA ANDA087479 Lake Erie Medical DBA Quality Care Products LLC HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 55700-238_fb9944c5-e36c-484e-94d7-06a52fade807 55700-238 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA090678 Lake Erie Medical DBA Quality Care Products LLC RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55700-239_48689aca-8d7f-44ce-9115-541badbae130 55700-239 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20150325 ANDA ANDA078722 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55700-240_a06bb9ee-8c03-4a77-964f-c8b13d09734e 55700-240 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 19920124 ANDA ANDA073457 Lake Erie Medical DBA Quality Care Products LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-241_57e65de2-84e4-449e-8048-2fd280c34771 55700-241 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Lake Erie Medical DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20191231 55700-242_cda03056-8c6d-4831-ba6b-fccd1f60ca78 55700-242 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA074644 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-243_1fcc3c18-0eee-4378-873f-461d41d9a7fb 55700-243 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073025 Lake Erie Medical DBA Quality Care Products LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-244_b2278569-629c-44eb-bb6f-3daec0288800 55700-244 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Lake Erie Medical DBA Quality Care Products LLC LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55700-245_15bd7469-0b0f-4479-a86e-dad3b7694ec6 55700-245 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20090724 ANDA ANDA076555 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55700-246_ca719bc7-7909-4a7f-98a1-5157b6ced279 55700-246 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021106 ANDA ANDA076201 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-248_013d1011-9796-453b-bbc3-f2d9abc01cb8 55700-248 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20020129 ANDA ANDA075967 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 55700-249_d248715f-f17b-4334-9f5f-c707d8f90b61 55700-249 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Lake Erie Medical DBA Quality Care Products LLC MIRTAZAPINE 30 mg/1 N 20181231 55700-250_93e22688-8d89-4835-a930-c43905292870 55700-250 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Lake Erie Medical DBA Quality Care Products LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20191231 55700-251_ef18959b-fe18-49b4-a248-36df5035ec20 55700-251 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 55700-252_f0d32720-e717-4256-87b8-fe520d7e2082 55700-252 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Lake Erie Medical DBA Quality Care Products LLC ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 55700-253_3586c8f3-5b95-4005-83bf-482dd4778c9b 55700-253 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-254_ca677f23-975f-4cda-b6d3-03770837eef9 55700-254 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20150205 ANDA ANDA077285 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 55700-255_88532dc0-a924-4cd1-9c97-172bb47782b1 55700-255 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20130227 NDA AUTHORIZED GENERIC NDA012462 Lake Erie Medical DBA Quality Care Products LLC DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 55700-256_0ee8c27d-c06f-4a24-ae62-bea85511c273 55700-256 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA076802 Lake Erie Medical DBA Quality Care Products LLC GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 55700-257_ca677f23-975f-4cda-b6d3-03770837eef9 55700-257 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20150217 ANDA ANDA077285 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 55700-258_50f9c71e-325c-4609-abda-2f24e5559a33 55700-258 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20130802 ANDA ANDA076070 Lake Erie Medical DBA Quality Care Products LLC NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55700-259_13b1125f-5b20-404e-920f-2bbf572ef49e 55700-259 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 NDA NDA021447 Lake Erie Medical DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55700-260_73e3afad-451f-40f6-89c0-a8fe0eb130d5 55700-260 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 55700-261_73e3afad-451f-40f6-89c0-a8fe0eb130d5 55700-261 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 55700-262_73e3afad-451f-40f6-89c0-a8fe0eb130d5 55700-262 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Lake Erie Medical DBA Quality Care Products LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 55700-263_e341bd3c-7e09-46ba-a8ac-b0182f68e51a 55700-263 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750519 ANDA ANDA084610 Lake Erie Medical DBA Quality Care Products LLC DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55700-266_b172d975-7f46-41f6-a182-b3938bc88952 55700-266 HUMAN OTC DRUG Senokot-S standardized senna concentrate and docusate sodium TABLET ORAL 19741001 OTC MONOGRAPH NOT FINAL part334 Lake Erie Medical DBA Quality Care Products LLC SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 E 20171231 55700-268_04f768ff-3978-421d-ae72-9e4aff338706 55700-268 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 55700-272_7ecbdb5d-97f6-4b15-8873-2026c97f46fa 55700-272 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20071121 ANDA ANDA040855 Lake Erie Medical DBAQuality Care Products LLC BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] E 20171231 55700-273_d89fd804-dcd7-40ab-b925-bce7406984a1 55700-273 HUMAN PRESCRIPTION DRUG URSODIOL URSODIOL TABLET, FILM COATED ORAL 20111223 ANDA ANDA200826 Lake Erie Medical DBA Quality Care Products LLC URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] E 20171231 55700-274_51c52177-b135-412d-be82-f5338405222a 55700-274 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072193 Lake Erie Medical DBA Quality Care Products LLC TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 55700-275_51c52177-b135-412d-be82-f5338405222a 55700-275 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072192 Lake Erie Medical DBA Quality Care Products LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 55700-276_e3e33d60-e3fc-4b12-a6df-4ae13c8571f6 55700-276 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55700-277_bde956e8-42f5-45c5-8318-f80fdf025d39 55700-277 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55700-278_c47efbd0-3d05-4597-aade-7da5644dace9 55700-278 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN TABLET, FILM COATED ORAL 20141101 ANDA ANDA203244 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55700-279_6fa602e4-9c0f-4015-aa18-08d36cbcb21b 55700-279 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55700-280_22d24115-0577-49a0-9c68-d17b6fb96faa 55700-280 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 Lake Erie Medical DBA Quality Care Products LLC FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 55700-281_83a7b82c-58be-4764-909a-6312d6fa4b0f 55700-281 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20070102 ANDA ANDA074722 Lake Erie Medical DBA Quality Care Products LLC INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 55700-282_0c579f08-a9b1-47c4-a2b7-6b22e2b73199 55700-282 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SOLUTION AURICULAR (OTIC) 20030318 ANDA ANDA062423 Lake Erie Medical DBA Quality Care Products LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [iU]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55700-283_bd37a6fb-8ae2-4d98-ae2c-ebcb6518cbb4 55700-283 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Lake Erie Medical DBA Quality Care Products LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 55700-284_37541d32-bc31-4f89-b02f-1ca8be2f9643 55700-284 HUMAN OTC DRUG Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20090317 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC OXYMETAZOLINE HYDROCHLORIDE 5 g/100mL E 20171231 55700-286_2320939a-c1d6-474a-92f3-71ce53aa4e5c 55700-286 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070974 Lake Erie Medical DBA Quality Care Products LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55700-287_4fbb8f6d-9081-401f-a07f-4cd8ba3bc370 55700-287 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130401 ANDA ANDA091283 Lake Erie Medical DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55700-288_f19afe0b-19e5-4b62-9506-e59b5913fd4d 55700-288 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130401 ANDA ANDA091283 Lake Erie Medical DBA Quality Care Products LLC TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55700-289_f89acefc-0605-4a4f-b8eb-57b7a1d44bc1 55700-289 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Lake Erie Medical DBA Quality Care Products LLC ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 55700-290_6f417e04-4793-4f9d-8185-e6cb5c5c67e3 55700-290 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Lake Erie Medical DBA Quality Care Products LLC BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55700-291_6f417e04-4793-4f9d-8185-e6cb5c5c67e3 55700-291 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Lake Erie Medical DBA Quality Care Products LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55700-293_b71d1e8f-e6e1-4d2a-b0c2-b74a097c01ae 55700-293 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150701 NDA NDA022370 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 55700-294_a1c86d6b-9ffa-41cb-86d6-3891650ece87 55700-294 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 Lake Erie Medical DBA Quality Care Products LLC CEFPROZIL 500 mg/1 N 20181231 55700-295_a01e2aac-8642-4d59-8521-f6a0e592c7b8 55700-295 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Lake Erie Medical DBA Quality Care Products LLC NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 55700-296_ccd7f715-a169-4c1a-8516-3bf53f231f4c 55700-296 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20121029 ANDA ANDA202764 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55700-297_54ddb1ef-a2d1-4c89-a168-7f20a5266f99 55700-297 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 19810226 ANDA ANDA086831 Lake Erie Medical DBA Quality Care Products LLC CHLORTHALIDONE 50 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 55700-298_8d8f26e9-dccf-4def-975b-65fa3290b353 55700-298 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 Lake Erie Medical DBA Quality Care Products LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 55700-299_c6dd1a3b-5b50-4782-b1a1-3cbf9c58f357 55700-299 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55700-300_866402ee-ab46-4d80-9d70-6985c1dd780b 55700-300 HUMAN OTC DRUG DocQLace docusate sodium CAPSULE ORAL 20110801 OTC MONOGRAPH NOT FINAL part334 Lake Erie Medical DBA Quality Care Products LLC DOCUSATE SODIUM 100 mg/1 N 20181231 55700-301_74138364-4f68-4fd8-91f1-97752b36d7e4 55700-301 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55700-302_08baddc7-e814-4a5e-a886-fc98860ab478 55700-302 HUMAN PRESCRIPTION DRUG Buprenorphine HCl Buprenorphine HCl TABLET SUBLINGUAL 20091008 ANDA ANDA078633 Lake Erie Medical DBA Quality Care Products LLC BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 55700-303_08baddc7-e814-4a5e-a886-fc98860ab478 55700-303 HUMAN PRESCRIPTION DRUG Buprenorphine HCl Buprenorphine HCl TABLET SUBLINGUAL 20091008 ANDA ANDA078633 Lake Erie Medical DBA Quality Care Products LLC BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 55700-305_42a7b791-6924-44a5-b577-f3c9b3ef1ef1 55700-305 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Lake Erie Medical DBA Quality Care Products LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 55700-306_77c8b1e1-556d-4ac7-9ff1-0b3313ad1e19 55700-306 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20020314 ANDA ANDA065063 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 55700-307_ad4a65c0-ac31-4d14-ae7b-f08fb38883c7 55700-307 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19920430 ANDA ANDA073281 Lake Erie Medical DBA Quality Care Products LLC TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55700-309_41a0cf42-41df-4611-af4b-d53444c2f7fa 55700-309 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070975 Lake Erie Medical DBA Quality Care Products LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55700-310_c2043cdc-3e48-43b0-b273-e4b2116ddd58 55700-310 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071134 Lake Erie Medical DBA Quality Care Products LLC DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 55700-311_0931e598-ab92-4534-8769-cdf3845ea329 55700-311 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 ANDA ANDA090478 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55700-313_324893f1-0d38-4e4d-a410-436f727173a8 55700-313 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Lake Erie Medical DBA Quality Care Products LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55700-314_5901cb41-9ba2-4943-a510-94735a04e675 55700-314 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071219 ANDA ANDA077056 Lake Erie Medical DBA Quality Care Products LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55700-315_20d25c03-7fbc-4fbb-a296-a8d013abe090 55700-315 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071972 Lake Erie Medical DBA Quality Care Products LLC PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-316_8a8a0ae4-f84c-4e9c-b1fe-42b906f823b5 55700-316 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-317_4f2bfc58-e1ef-42e6-a644-30c563cb8ebc 55700-317 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Lake Erie Medical DBA Quality Care Products LLC BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55700-317_6a2416b5-2e7c-4a3f-a837-57b7e7070bca 55700-317 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Lake Erie Medical DBA Quality Care Products LLC BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 55700-318_d77e968d-b920-4f5c-8656-5037b274d911 55700-318 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA090970 Lake Erie Medical DBA Quality Care Products LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 55700-319_31dc737d-3e32-4127-8105-3cf6daa12212 55700-319 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Lake Erie Medical DBA Quality Care Products LLC FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 55700-320_a79f7551-8852-482c-9256-b3421f096a30 55700-320 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55700-321_9037e0b5-c976-4acb-99f4-4e804529ceba 55700-321 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20060331 ANDA ANDA085025 Lake Erie Medical DBA Quality Care Products LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55700-322_49fdcd8d-a47a-4fa8-823c-141a3eb5a84a 55700-322 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Lake Erie Medical DBA Quality Care Products LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 55700-323_1d9055b1-ce59-4d74-9d70-ee1c281480a7 55700-323 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20001201 ANDA ANDA065055 Lake Erie Medical DBA Quality Care Products LLC DOXYCYCLINE 100 mg/1 N 20181231 55700-324_14430749-de87-41d1-9606-9d97e166a696 55700-324 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Lake Erie Medical DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-325_3d418d91-4edd-429d-b73b-e912f65d91fd 55700-325 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060130 ANDA ANDA077651 Lake Erie Medical DBA Quality Care Products LLC ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55700-328_8a9182f9-25a7-4478-91c3-78181407ade8 55700-328 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Lake Erie Medical DBA Quality Care Products LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 55700-330_bb30682f-99e5-48ba-9bc6-510cd5c9f75d 55700-330 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 19840420 ANDA ANDA070624 Lake Erie Medical DBA Quality Care Products LLC INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-331_26df8f93-8b93-4bc8-a8e1-cb40d1c814fb 55700-331 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Lake Erie Medical DBA Quality Care Products LLC CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 55700-332_a32f8924-8676-4cec-8172-de475e3fdabc 55700-332 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 19930101 ANDA ANDA064013 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-333_72cef4a8-60ed-4b11-bf15-20bc33eb6dc5 55700-333 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20031107 ANDA ANDA065085 Lake Erie Medical DBA Quality Care Products LLC MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 55700-334_3c88336e-9098-40f8-b729-5054d829144d 55700-334 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151012 NDA AUTHORIZED GENERIC NDA022272 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-335_1d4747be-0964-4cfd-893a-1cbf074003a6 55700-335 HUMAN OTC DRUG Rugby All Day Relief Naproxen Sodium TABLET, FILM COATED ORAL 20150902 ANDA ANDA074661 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN SODIUM 220 mg/1 N 20181231 55700-336_596d9d56-af9e-4962-b012-3ea293268a40 55700-336 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20130325 ANDA ANDA086724 Lake Erie Medical DBA Quality Care Products LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55700-337_2f972aa3-4453-4e71-9a06-6d62fae00be1 55700-337 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150312 ANDA ANDA200562 Lake Erie Medical DBA Quality Care Products LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-338_3b7c925e-8f7c-494a-8985-388e661e15bc 55700-338 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 Lake Erie Medical DBA Quality Care Products LLC ASPIRIN 325 mg/1 N 20181231 55700-340_250dce6d-125f-44e9-99ba-735002f1fa81 55700-340 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 Lake Erie Medical DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-341_832ff49a-8522-4eab-a97c-ae6728652691 55700-341 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Lake Erie Medical Medical DBA Quality Care Products LLC MIRTAZAPINE 15 mg/1 N 20181231 55700-342_438d2ae3-4dc2-4367-8858-0550424d2ed8 55700-342 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20130531 ANDA ANDA203399 Lake Erie Medical DBA Quality Care Products LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 55700-343_d93b4177-9fcf-40f7-b0db-aaa4769bee34 55700-343 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076410 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 55700-344_ad2c82c1-99fe-4667-aa3b-0fcd8311f92e 55700-344 HUMAN PRESCRIPTION DRUG Terbinafine Terbinafine Hydrochloride TABLET ORAL 20070702 ANDA ANDA078297 Lake Erie Medical DBA Quality Care Products LLC TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] E 20171231 55700-345_df89b94e-92a5-478d-a7f2-4ff36f3def69 55700-345 HUMAN PRESCRIPTION DRUG valacyclovir hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120405 ANDA ANDA201506 Lake Erie Medical DBA Quality Care Products LLC VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55700-346_54745c14-eda3-4b24-b1a9-dc968ce8903b 55700-346 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20150831 ANDA ANDA204821 Lake Erie Medical DBA Quality Care Products LLC VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55700-347_54745c14-eda3-4b24-b1a9-dc968ce8903b 55700-347 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20150831 ANDA ANDA204821 Lake Erie Medical DBA Quality Care Products LLC VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55700-348_451fced4-fe5a-4fc0-83d7-66e4ce8c174d 55700-348 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980731 ANDA ANDA075227 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 55700-349_ec653437-12dc-4f05-8c4d-e5cee4d43312 55700-349 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-350_fd8e652e-9e26-41d2-9050-637792a6aa7a 55700-350 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20130630 ANDA ANDA202104 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-351_735a384b-a6e9-4cd4-980c-912d6e19f81d 55700-351 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Lake Erie Medical DBA Quality Care Products LLC AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55700-352_5884dc52-f0fd-4c29-9893-1a0ca677ce53 55700-352 HUMAN PRESCRIPTION DRUG Diclofenac sodium Diclofenac sodium SOLUTION TOPICAL 20150406 ANDA ANDA202852 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-353_72d17b8d-e9fd-4b51-8bf6-979d21fae6e3 55700-353 HUMAN OTC DRUG Senna-S Docusate Sodium and Sennosides TABLET, FILM COATED ORAL 20020503 OTC MONOGRAPH NOT FINAL part334 Lake Erie Medical DBA Quality Care Products LLC DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 55700-354_eafc09f4-b056-4728-a618-143f4706b8a4 55700-354 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20130708 ANDA ANDA076008 Lake Erie Medical DBA Quality Care Products LLC BUSPIRONE HYDROCHLORIDE 7.5 mg/1 E 20171231 55700-355_f9344211-5dee-4324-9957-5cfc5003b3f9 55700-355 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-356_1b3636ae-225e-46a9-a777-b9a39723cee4 55700-356 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Lake Erie Medical DBA Quality Care Products LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-357_c59a2274-5767-4a63-b68e-2cfdd002b055 55700-357 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 55700-358_249f48fa-9cfa-420d-9e80-afa744b7056c 55700-358 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140909 ANDA ANDA063083 Lake Erie Medical DBA Quality Care Products LLC CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 55700-359_b8915518-54aa-4f05-86ed-50b1379958f7 55700-359 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride CAPSULE ORAL 20160122 ANDA ANDA040319 Lake Erie Medical DBA Quality Care Products LLC DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 55700-360_e8bd4874-0e38-4539-8f09-75a09412b80b 55700-360 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55700-361_f9dde5d4-970d-41fc-bd02-77efc4ec8934 55700-361 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 19931222 ANDA ANDA074201 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-362_d509b4ba-360e-42a3-b4f5-56a879207993 55700-362 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 Lake Erie Medical DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-363_0e10dc4f-3d67-413f-a1e8-88ee553381b3 55700-363 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20150601 ANDA ANDA081297 Lake Erie Medical DBA Quality Care Products LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 55700-364_6546cc30-4e28-4748-be30-9bc246f6f648 55700-364 HUMAN PRESCRIPTION DRUG Cephalexin cephalexin CAPSULE ORAL 20150602 ANDA ANDA062713 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55700-365_cada25cb-d942-4f9c-bf56-d7b115fe8cf4 55700-365 HUMAN OTC DRUG SennaLax-S senna and docusate sodium TABLET, FILM COATED ORAL 20070726 OTC MONOGRAPH NOT FINAL part334 Lake Erie Medical DBA Quality Care Products LLC DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 55700-366_b6447a34-557d-49ff-88ae-d73f937397fe 55700-366 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151026 ANDA ANDA203849 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-367_ed46fab8-e102-4a8f-bb16-bc451773911d 55700-367 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151026 ANDA ANDA203849 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-368_b6447a34-557d-49ff-88ae-d73f937397fe 55700-368 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151026 ANDA ANDA203849 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-371_1245b47c-d099-474e-be49-c07983100275 55700-371 HUMAN OTC DRUG Aller-chlor Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 55700-372_b2aa7551-8413-4583-bdd6-b97896d849c9 55700-372 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 19991103 ANDA ANDA040317 Lake Erie Medical DBA Quality Care Products LLC DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 55700-373_5a2a44d9-fe78-4735-994b-a47bbbf11ead 55700-373 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131101 ANDA ANDA040778 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-374_d721e535-6f15-4cbc-bb62-410d00ddd795 55700-374 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20160115 ANDA ANDA064076 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-375_77c8b1e1-556d-4ac7-9ff1-0b3313ad1e19 55700-375 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20020315 ANDA ANDA065064 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 55700-376_70e696e9-30a0-4f46-8e52-d29d8a4ab243 55700-376 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA076862 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-377_e70f1765-b361-4fc5-aec2-68f89a99ce55 55700-377 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA076048 Lake Erie Medical DBA Quality Care Products LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55700-378_6b44dc58-8a8a-4ca9-8469-8c6bdb959d21 55700-378 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100710 NDA NDA018851 Lake Erie Medical DBA Quality Care Products LLC INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-379_3c811a07-7c56-4483-b010-6c6865d9fa43 55700-379 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 Lake Erie Medical DBA Quality Care Products LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-380_d773f9a7-669e-41c2-85a4-bd122739c7c4 55700-380 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19931129 ANDA ANDA064052 Lake Erie Medical DBA Quality Care Products LLC TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 55700-381_31215707-e716-4f44-aaa0-9a565c4fbe62 55700-381 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-382_ed6c76ea-ee18-47b9-b6ac-0d4f96537f79 55700-382 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20071121 ANDA ANDA040855 Lake Erie Medical DBA Quality Care Products LLC BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 55700-383_fbd912ef-869e-44aa-819a-aedcef53f582 55700-383 HUMAN PRESCRIPTION DRUG MOVANTIK naloxegol oxalate TABLET, FILM COATED ORAL 20150306 NDA NDA204760 Lake Erie Medical DBA Quality Care Products LLC NALOXEGOL OXALATE 25 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 55700-384_0fbfe099-931e-45fb-86bb-39b1e16e8763 55700-384 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20120312 ANDA ANDA040911 Lake Erie Medical DBA Quality Care Products LLC LIDOCAINE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55700-385_8ce3838f-2cd3-4086-b171-5389a03e70a1 55700-385 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 19960730 ANDA ANDA040105 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-386_81d745a5-24e1-4c7a-982b-1352c361bf0f 55700-386 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN CAPSULE ORAL 20121015 ANDA ANDA090007 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55700-387_31215707-e716-4f44-aaa0-9a565c4fbe62 55700-387 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-388_c689395c-a0a1-4e7e-84bf-846642584ca4 55700-388 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Lake Erie Medical DBA Quality Care Products LLC NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 55700-389_f9b78fac-1d3e-468e-bdeb-422a06cc3092 55700-389 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN TABLET, FILM COATED ORAL 20141101 ANDA ANDA203244 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55700-390_69d7f6a7-46ff-478b-82a2-ae079aec26af 55700-390 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Lake Erie Medical DBA Quality Care Products LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 55700-391_3d3a21f6-1f58-4ef7-9801-5abd080794e1 55700-391 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Lake Erie Medical DBA Quality Care Products LLC AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55700-392_880d4c39-8349-466e-9b18-205956aa3224 55700-392 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20150909 ANDA ANDA201003 Lake Erie Medical DBA Quality Care Products LLC RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 55700-393_ed81abd4-8868-4e7e-9636-5699dd46d885 55700-393 HUMAN PRESCRIPTION DRUG LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED RELEASE ORAL 20121218 ANDA ANDA201921 Lake Erie Medical DBA Quality Care Products LLC LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 55700-394_1c9201cc-52cf-481c-a081-b41856be2a1a 55700-394 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA073449 Lake Erie Medical DBA Quaity Care Products LLC TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55700-395_f9e62254-731c-41d0-a9f7-a667a21d238d 55700-395 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55700-397_44cab1c1-d3c7-49a4-9115-bf9384f5770b 55700-397 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Lake Erie Medical DBA Quality Care Products LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55700-398_962d19fc-c704-49a4-8bb8-437abb6fdbca 55700-398 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20151118 ANDA ANDA203963 Lake Erie Medical DBA Quality C SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 55700-399_c50a6809-8187-4db9-b986-a8dac7fc140e 55700-399 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 Lake Erie Medical DBA Quality Care Products LLC ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 55700-400_f6b18f75-c977-404c-9c7d-8922cf6b0138 55700-400 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Extended-Release Hydromorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140612 NDA AUTHORIZED GENERIC NDA021217 Lake Erie Medical DBA Quality Care Products LLC HYDROMORPHONE HYDROCHLORIDE 16 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-401_ef81753d-9b6f-4a0e-bb01-9add5ac0f8d1 55700-401 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 Lake Erie Medical DBA Quality Care Products LLC NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55700-402_cdb0d55e-4716-4fc3-b837-7c68cacbb91d 55700-402 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Lake Erie Medical DBA Quality Care Products LLC FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-403_c0d24203-4ef8-4749-81ce-56c8a20535c0 55700-403 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20070701 ANDA ANDA078220 Lake Erie Medical DBA Quality Care Products LLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 55700-404_1b1fc2d4-3d7a-4127-a7a6-5ea00cac0297 55700-404 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 19951130 ANDA ANDA064071 Lake Erie Medical DBA Quality Care Products LLC PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-405_081b314d-f198-48d9-8daa-2053c94b7fe0 55700-405 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20160423 NDA NDA021210 Lake Erie Medical DBA Quality Care Products LLC LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 55700-406_14be5669-6b24-4175-9222-076c7d00ef08 55700-406 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-407_2a0a5eeb-68fe-4524-aa93-b00accb19b7f 55700-407 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20150212 ANDA ANDA202392 Lake Erie Medical DBA Quality Care Products LLC RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55700-408_c1c6fdbb-b6d3-410a-ba87-c21a4daa6508 55700-408 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20051201 ANDA ANDA077241 Lake Erie Medical DBA Quality Care Products LLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 55700-409_98ff73e0-382c-4655-ae68-ecece7c77790 55700-409 HUMAN PRESCRIPTION DRUG Linzess linaclotide CAPSULE, GELATIN COATED ORAL 20120830 NDA NDA202811 Lake Erie Medical DBA Quality Care Products LLC LINACLOTIDE 145 ug/1 Guanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA] N 20181231 55700-410_b9d92547-4a9d-4718-aec8-ae0808c3e066 55700-410 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20140301 ANDA ANDA078490 Lake Erie Medical DBA Quality Care Products LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55700-411_0c6c8f33-b938-4466-8ade-ea290325f39f 55700-411 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET ORAL 20150513 ANDA ANDA079128 Lake Erie Medical DBA Quality Care Products LLC LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 55700-412_96f0cc71-5513-417c-99a5-ccdaf76662af 55700-412 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE Tramadol hydrochloride TABLET ORAL 20150522 ANDA ANDA091498 Lake Erie Medical DBA Quality Care Products LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 55700-413_39a20487-c026-4194-abe5-654f941a84eb 55700-413 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20160531 ANDA ANDA071974 Lake Erie Medical DBA Quality Care Products LLC PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-414_7ef4a920-1eda-4e61-a5b7-0b51456db3e4 55700-414 HUMAN PRESCRIPTION DRUG Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate SOLUTION OPHTHALMIC 19981217 ANDA ANDA065006 Lake Erie Medical DBA Quality Care Products LLC TRIMETHOPRIM SULFATE; POLYMYXIN B SULFATE 1; 10000 mg/mL; [USP'U]/mL Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 55700-415_085af489-3501-4378-901c-ed01043947d1 55700-415 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20150402 ANDA ANDA065062 Lake Erie Medical DBA Quality Care Products LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 55700-416_8907f10b-44fc-4356-b83a-6ead5173a620 55700-416 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-417_31215707-e716-4f44-aaa0-9a565c4fbe62 55700-417 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-418_60e8de4e-fa59-4a54-843c-f2285af52adf 55700-418 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 55700-419_60ea5340-a135-49a4-b820-c0d41f93b6ba 55700-419 HUMAN PRESCRIPTION DRUG NUCYNTA ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110825 NDA NDA200533 Lake Erie Medical DBA Quality Care Products LLC TAPENTADOL HYDROCHLORIDE 150 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 55700-420_3fd7db9a-cb3a-4cd2-9d74-959187b28980 55700-420 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20030925 ANDA ANDA076290 Lake Erie Medical DBA Quality Care Products LLC LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 55700-422_cadd3712-3c0d-4745-8d90-88b1bab5eed6 55700-422 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120723 ANDA ANDA074215 Lake Erie Medical DBA Quality Care Products LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55700-423_31215707-e716-4f44-aaa0-9a565c4fbe62 55700-423 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-424_10a045c5-8daf-4139-a150-51c6055ecf38 55700-424 HUMAN PRESCRIPTION DRUG acetic acid acetic acid SOLUTION AURICULAR (OTIC) 20100122 NDA NDA012179 Lake Erie Medical DBA Quality Care Products LLC ACETIC ACID 20.65 mg/mL N 20181231 55700-425_8def34fa-aecd-4b23-9817-8e7837275f42 55700-425 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19941019 ANDA ANDA074131 Lake Erie Medical DBA Quality Care Products LLC PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-426_8199a5a3-25f6-4b9e-990b-998e8aaa8336 55700-426 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20090714 ANDA ANDA078103 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55700-427_52c0a730-3431-4d6c-9238-97d2569edf8e 55700-427 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160222 NDA NDA022272 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-428_975aba6b-d648-4e90-aab9-9ba5d85a42a2 55700-428 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE ORAL 20151019 ANDA ANDA203636 Lake Erie Medical DBA Quality Care Products LLC ESOMEPRAZOLE MAGNESIUM 40 1/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 55700-429_5d0bbd47-8c97-4795-9503-9176be22ad90 55700-429 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20160201 ANDA ANDA206827 Lake Erie Medical DBA Quality Care Products LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-430_41acc7dc-ce13-4221-ab86-2004ae117b8a 55700-430 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20160201 ANDA ANDA206827 Lake Erie Medical DBA Quality Care Products LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-431_d4b1ba3e-3e1f-4964-a817-ef130238985f 55700-431 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160222 NDA NDA022272 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-432_bd15e457-4be3-4bc9-b14a-bdaffb8365ec 55700-432 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150722 ANDA ANDA065398 Lake Erie Medical DBA Quality Care Products LLC AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55700-433_da3174cb-7e88-4312-b3a5-bc22526f498a 55700-433 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Lake Erie Medical DBA Quality Care Products LLC BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 55700-434_2048d8a9-a093-4e43-ba2b-cd70067639f8 55700-434 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA078424 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 500 mg/1 N 20181231 55700-435_597a1d52-99d1-4e46-8a40-95af6ff9fe53 55700-435 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140820 ANDA ANDA202045 Lake Erie Medical DBA Quality Care Products LLC DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-436_dd716d96-b6e5-4bc4-96b9-5849e234d3da 55700-436 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 Lake Erie Medical DBA Quality Care Products LLC CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55700-437_4a3146c6-6602-4296-aeee-30e4a369c3d5 55700-437 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160222 NDA NDA022272 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-438_0fa393f7-c136-43ec-b89d-f017c2cddad7 55700-438 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20161007 NDA NDA018851 Lake Erie Medical DBA Quality Care Products LLC INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-439_36e442e8-af68-4c54-8e00-b441b760ab68 55700-439 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071135 Lake Erie Medical DBA Quality Care Products LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55700-440_83857517-e271-407b-80d5-398535dc5833 55700-440 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Lake Erie Medical DBA Quality Care Products LLC PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-441_bc5aae7d-a068-441d-b675-6b293a57aee9 55700-441 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130102 ANDA ANDA079087 Lake Erie Medical DBA Quality Care Products LLC OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-442_36e442e8-af68-4c54-8e00-b441b760ab68 55700-442 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071136 Lake Erie Medical DBA Quality Care Products LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55700-443_ef229b37-33d3-41c5-b814-9d72e9e5071d 55700-443 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140903 NDA AUTHORIZED GENERIC NDA022272 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-444_a2a7689f-bb0d-4740-8e86-a27824d887e9 55700-444 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20160602 ANDA ANDA065063 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 55700-445_93a44e86-3e75-49bf-83e5-48616f229cdf 55700-445 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 Lake Erie Medical DBA Quality Care Products LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-446_93a44e86-3e75-49bf-83e5-48616f229cdf 55700-446 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 Lake Erie Medical DBA Quality Care Products LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-447_c9a06cb7-2d16-4b64-9bc5-4c8e64636c94 55700-447 HUMAN PRESCRIPTION DRUG OXAYDO OXYCODONE HYDROCHLORIDE TABLET ORAL 20150901 NDA NDA202080 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-448_c9a06cb7-2d16-4b64-9bc5-4c8e64636c94 55700-448 HUMAN PRESCRIPTION DRUG OXAYDO OXYCODONE HYDROCHLORIDE TABLET ORAL 20150901 NDA NDA202080 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-449_c7cafb22-879c-4a86-9893-8d275898e850 55700-449 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20150923 ANDA ANDA207446 Lake Erie Medical DBA Quality Care Products LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-450_c7cafb22-879c-4a86-9893-8d275898e850 55700-450 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20150923 ANDA ANDA207446 Lake Erie Medical DBA Quality Care Products LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-451_273e4d16-7fa6-4fee-ba16-6d697bc9d8d2 55700-451 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20100701 ANDA ANDA040823 Lake Erie Medical DBA Quality Care Products LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55700-452_32eb0113-85eb-4e0b-baad-13f1aec9c5c7 55700-452 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Lake Erie Medical DBA Quality Care Products LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55700-453_512eb8d3-90d5-4dc2-bd30-78d61168b83b 55700-453 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55700-454_c6a3791e-35a9-4d85-aa63-e441330a771b 55700-454 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 Lake Erie Medical DBA Quality Care Products LLC LEVOFLOXACIN 500 mg/1 N 20181231 55700-455_36005516-3391-4b21-80e3-9b37b468f618 55700-455 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20140801 ANDA ANDA065235 Lake Erie Medical DBA Quality Care Products LLC CEFPROZIL 500 mg/1 N 20181231 55700-456_cedcd1e2-6f0a-4ec9-bb21-d76c486c272d 55700-456 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021121 ANDA ANDA065093 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 55700-457_818370e2-6125-4aed-9840-1dd40e754889 55700-457 HUMAN PRESCRIPTION DRUG NARCAN naloxone hydrochloride SPRAY NASAL 20151118 NDA NDA208411 Lake Erie Medical DBA Quality Care Products LLC NALOXONE HYDROCHLORIDE 4 mg/.1mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 55700-458_1a673cc7-81c7-4078-ac62-f4dd8dbaffae 55700-458 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20160803 ANDA ANDA040197 Lake Erie Medical DBA Quality Care Products LLC ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 55700-459_729f751e-f360-451a-b8a7-a6a01252db9a 55700-459 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55700-460_5e2d9118-8cae-49a4-b6b9-2ac343900204 55700-460 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20161031 ANDA ANDA076504 Lake Erie Medical DBA Quality Care Products LLC FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55700-461_33cee7e4-8e1c-443c-bd62-bf0bb1e0b6b7 55700-461 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Lake Erie Medical DBA Quality Care Products LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55700-462_e1f4e454-daf1-408a-94f1-f764fce3b8c1 55700-462 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160222 NDA AUTHORIZED GENERIC NDA022272 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-463_62304862-d1ea-4e2f-9d7c-4a3e5f7aed0c 55700-463 HUMAN PRESCRIPTION DRUG naproxen naproxen TABLET ORAL 20160705 ANDA ANDA091305 Lake Erie Medical DBA Quality Care Products LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-464_6e4b2018-2db0-4e0a-a45c-77cbcc78f194 55700-464 HUMAN PRESCRIPTION DRUG Lidocaine lidocaine OINTMENT TOPICAL 20160201 ANDA ANDA205318 Lake Erie Medical DBA Quality Care Products LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 55700-465_47e92ee8-9312-45cc-8cd8-2211fa84322f 55700-465 HUMAN OTC DRUG Good Neighbor Pharmacy Childrens Allergy Diphenhydramine Hydrochloride SOLUTION ORAL 19890815 OTC MONOGRAPH FINAL part341 Lake Erie Medical DBA Quality Care Products LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 55700-466_8d57557f-bc74-4ea6-a505-bf7e2a53a9c2 55700-466 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55700-467_773da83b-5d77-45ea-afc0-7b97806f0ed7 55700-467 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065378 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-468_4efd016e-a67e-4b04-abc1-8297a268e8b3 55700-468 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-469_4b2fe109-f668-493f-8499-64dde41904d4 55700-469 HUMAN PRESCRIPTION DRUG glyburide and metformin hydrochloride glyburide and metformin hydrochloride TABLET ORAL 20160407 ANDA ANDA206748 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55700-470_5d5750c0-199e-4314-8d9a-b582a3b49050 55700-470 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 20170113 ANDA ANDA062500 Lake Erie Medical DBA Quality Care Products LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 55700-471_8cd5e71d-4ccc-4f33-b8cf-6c6208a5e48e 55700-471 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20040923 ANDA ANDA065162 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-472_285f45e1-a00e-4227-a3ce-9c11d786783e 55700-472 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130617 ANDA ANDA202297 Lake Erie Medical DBA Quality Care Products LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 55700-473_fbff1daa-9683-46be-b06b-947563b05ec3 55700-473 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130418 ANDA ANDA202556 Lake Erie Medical DBA Quality Care Products LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 55700-474_6ea81244-0cae-44a6-9070-4e037c1a36b0 55700-474 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan potassium TABLET, FILM COATED ORAL 20170113 ANDA ANDA091497 Lake Erie Medical DBA Quality Care Products LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 55700-475_90edb7b3-42a0-45ae-bace-11f849bdd933 55700-475 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20170113 ANDA ANDA091184 Lake Erie Medical DBA Quality Care Products LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 55700-476_0aaa7120-686b-4578-9e27-320a5af6e32d 55700-476 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20170113 ANDA ANDA205245 Lake Erie Medical DBA Quality Care Products LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 55700-477_a27f830e-7c9b-432e-b3c4-7b991fa549f5 55700-477 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Lake Erie Medical DBA Quality Care Products LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55700-478_232055ef-ec5a-45bf-b27d-b4225a60cb34 55700-478 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 Lake Erie Medical DBA Quality Care Products LLC ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 55700-479_cbc5dc9c-620a-4d0f-ad55-52e9322c8b6e 55700-479 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 55700-480_cbc5dc9c-620a-4d0f-ad55-52e9322c8b6e 55700-480 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20170113 ANDA ANDA076164 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 55700-481_1e528aa5-36e4-46ef-9d99-68a65ad03d65 55700-481 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20091010 ANDA ANDA076126 Lake Erie Medical DBA Quality Care Products LLC CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 55700-482_35bba3e1-fd12-4d59-997c-77c8bfbe6c2f 55700-482 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20170113 ANDA ANDA073144 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55700-483_7b63d19c-7b92-48b5-8e42-4af82a8ca3fb 55700-483 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55700-484_82adf2c8-4c9d-4117-a2f7-65a6e053acdd 55700-484 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070727 ANDA ANDA077851 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55700-485_4b5747c7-ff7e-4621-ac33-1a6d397c1b6f 55700-485 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20160718 ANDA ANDA073553 Lake Erie Medical DBA Quality Care Products LLC NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55700-486_4b5747c7-ff7e-4621-ac33-1a6d397c1b6f 55700-486 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20160718 ANDA ANDA073554 Lake Erie Medical DBA Quality Care Products LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55700-487_77ac3ed7-1ef6-4474-bffe-351587bdb1d6 55700-487 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160725 ANDA ANDA206674 Lake Erie Medical DBA Quality Care Products LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 55700-488_234b8f5a-2ac6-481d-9152-9e44ae016e0d 55700-488 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20170120 NDA NDA021446 Lake Erie Medical DBA Quality Care Products LLC PREGABALIN 225 mg/1 CV N 20181231 55700-489_cd9ea5f2-fa10-4fcd-b005-8fad5c8effd6 55700-489 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20120703 NDA NDA021282 Lake Erie Medical DBA Quality Care Products LLC GUAIFENESIN 600 mg/1 N 20181231 55700-490_3843d771-7bbe-481a-8272-bb9a4402e8db 55700-490 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20110307 ANDA ANDA078423 Lake Erie Medical DBA Quality Care Products LLC FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 55700-491_48d6cb0f-e347-4649-8628-15434b4373c2 55700-491 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20170127 ANDA ANDA200739 Lake Erie Medical DBA Quality Care Products LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 55700-492_c167279b-445d-4d70-b5ac-795c3f521e88 55700-492 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20170127 ANDA ANDA071745 Lake Erie Medical DBA Quality Care Products LLC PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 55700-493_1a4bc1df-aa49-4c09-95e8-45d3c859ae38 55700-493 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20161013 ANDA ANDA077836 Lake Erie Medical DBA Quality Care Products LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 55700-494_18151100-77d2-4151-9e61-e909ccd834ed 55700-494 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20161122 ANDA ANDA204770 Lake Erie Medical DBA Quality Care Products LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 55700-495_445fa030-3892-482c-bb36-79bc618ba636 55700-495 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110607 ANDA ANDA078179 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 55700-496_658d79c4-063a-4b2c-89f0-aa054d054bba 55700-496 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20161201 ANDA ANDA201972 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-497_658d79c4-063a-4b2c-89f0-aa054d054bba 55700-497 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20161201 ANDA ANDA201972 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-498_658d79c4-063a-4b2c-89f0-aa054d054bba 55700-498 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20161201 ANDA ANDA201972 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-499_0da3748e-eae8-4743-b070-762fb07c4ebf 55700-499 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Lake Erie Medical DBA Quality Care Products LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-500_e9eaf1b1-434e-4f0a-ab34-753fffda6d5b 55700-500 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET, FILM COATED ORAL 20150916 ANDA ANDA204507 Lake Erie Medical DBA Quality Care Products LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 55700-501_2ee133d2-58f5-4f15-9af1-16ee9fed8923 55700-501 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Lake Erie Medical DBA Quality Care Products LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 55700-502_f6ca0d63-6ef3-461a-887b-ff98e03d9c58 55700-502 HUMAN OTC DRUG Bisacodyl bisacodyl TABLET, DELAYED RELEASE ORAL 20170210 OTC MONOGRAPH NOT FINAL part334 Lake Erie Medical DBA Quality Care Products LLC BISACODYL 5 mg/1 N 20181231 55700-503_0fbb5674-b7d2-435f-9f69-1688177bc0db 55700-503 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 Lake Erie Medical DBA Quality Care Products LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-504_3a650f83-461a-481e-a6bf-e0d6ed90596c 55700-504 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20160803 ANDA ANDA040197 Lake Erie Medical DBA Quality Care Products LLC ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 55700-505_01b14fbb-ed7d-41ae-a84a-e598db0fbe31 55700-505 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Lake Erie Medical DBA Quality Care Products LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-506_26e20182-5c91-4066-b9f3-9ad5e6e94ca8 55700-506 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130319 ANDA ANDA202389 Lake Erie Medical DBA Quality Care Products LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-507_26e20182-5c91-4066-b9f3-9ad5e6e94ca8 55700-507 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130321 ANDA ANDA202389 Lake Erie Medical DBA Quality Care Products LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-508_a1a6f973-74fa-4818-8b8e-4389a714608b 55700-508 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20151020 ANDA ANDA077578 Lake Erie Medical DBA Quality Care Products LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 55700-509_52a7f20c-627f-436a-a804-15f63888b33f 55700-509 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-510_7a37a6a3-9505-4e26-bd44-9e378f7a9283 55700-510 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161129 NDA AUTHORIZED GENERIC NDA021875 Lake Erie Medical DBA Quality Care Products LLC ARMODAFINIL 250 mg/1 CIV N 20181231 55700-511_4321e7db-d2cd-4c81-9bd2-9f6d3bb9cc57 55700-511 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM diclofenac sodium GEL TOPICAL 20160913 ANDA ANDA208301 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-512_26fa7975-1ceb-43fc-a4ad-f8878d0bae55 55700-512 HUMAN OTC DRUG Enteric Coated Stimulant Laxative Bisacodyl TABLET, DELAYED RELEASE ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Lake Erie Medical DBA Quality Care Products LLC BISACODYL 5 mg/1 N 20181231 55700-513_cdb93816-9c6d-4bf6-8b81-cec5444d40dd 55700-513 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55700-514_cdb93816-9c6d-4bf6-8b81-cec5444d40dd 55700-514 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55700-515_ef6716f0-7a82-4d7b-af57-5bb53f64e757 55700-515 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20170406 ANDA ANDA078103 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55700-516_cdaad8d3-683b-4a8c-a947-68c69dad4b3d 55700-516 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20170414 ANDA ANDA079170 Lake Erie Medical DBA Quality Care Products LLC ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55700-517_8a39c07e-59e5-43cc-96a3-9d6ae39b04d2 55700-517 HUMAN PRESCRIPTION DRUG Lorzone chlorzoxazone TABLET ORAL 20111001 ANDA ANDA040861 Lake Erie Medical DBA Quality Care Products LLC CHLORZOXAZONE 375 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55700-518_edeba2cb-6c19-4e16-a211-659c9d3447ec 55700-518 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110106 ANDA ANDA090899 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-519_edeba2cb-6c19-4e16-a211-659c9d3447ec 55700-519 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20170421 ANDA ANDA090899 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-520_edeba2cb-6c19-4e16-a211-659c9d3447ec 55700-520 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110106 ANDA ANDA090899 Lake Erie Medical DBA Quality Care Products LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-521_9555fe6d-bb56-410c-a47b-fe967e8d12a1 55700-521 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20170224 ANDA ANDA078423 Lake Erie Medical DBA Quality Care Products LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 55700-522_cce0ad7e-506b-4a96-8fd4-e609ad43c321 55700-522 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070813 ANDA ANDA078050 Lake Erie Medical DBA Quality Care Products LLC ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 55700-523_7bd189cf-07f5-41be-872d-a640b94249f9 55700-523 HUMAN OTC DRUG LidoPro Capsaicin, Lidocaine, Menthol, and Methyl Salicylate OINTMENT TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Lake Erie Medical DBA Quality Care Products LLC CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE .000325; .04; .1; .275 g/g; g/g; g/g; g/g N 20181231 55700-524_3878ff9d-ddc8-4ee6-adba-3231ba9992ed 55700-524 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20151106 ANDA ANDA202894 Lake Erie Medical DBA Quality Care Products LLC CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55700-525_fb8be645-e026-4b32-a6db-eb31a3ddf97a 55700-525 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107 ANDA ANDA065434 Lake Erie Medical DBA Quality Care Products LLC CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55700-526_c594e021-ebcd-409d-8fb4-f7f96fe450cd 55700-526 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Lake Erie Medical DBA Quality Care Products LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 55700-527_d006006f-d690-4354-a8a4-b35669e6f5e9 55700-527 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 55700-528_98522179-a908-4d24-b7f9-45e3fb33afe9 55700-528 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium GEL TOPICAL 20160616 NDA AUTHORIZED GENERIC NDA022122 Lake Erie Medical DBA Quality Care Products LLC DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-529_faf7b93d-3931-4526-86f7-f021cf94f148 55700-529 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161215 ANDA ANDA202557 Lake Erie Medical DBA Quality Care Products LLC BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 55700-530_faf7b93d-3931-4526-86f7-f021cf94f148 55700-530 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161215 ANDA ANDA202557 Lake Erie Medical DBA Quality Care Products LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 55700-531_51c59e21-1d3f-49b4-a13b-1854233ffe0c 55700-531 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20171215 ANDA ANDA076900 Lake Erie Medical DBA Quality Care Procucts LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-531_5b338229-eae6-4e42-8200-1f9ab3f7996e 55700-531 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20170623 ANDA ANDA076900 Lake Erie Medical DBA Quality Care Products LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-532_d6dfd492-aea3-4bc2-ae72-beff1a911e8f 55700-532 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Lake Erie Medical DBA Quality Care Products LLC NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 55700-533_be39eba9-8b3a-4714-9e64-32421bdd52fb 55700-533 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20170629 ANDA ANDA065229 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55700-534_0da86148-0e7b-4907-be86-b6505b1a5f4e 55700-534 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Lake Erie Medical DBA Quality Care Products LLC ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55700-535_9d4c1c44-3280-446b-86a3-de9c8bee877e 55700-535 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20151204 ANDA ANDA203584 Lake Erie Medical DBA Quality Care Products LLC CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 55700-536_2bfb7067-a367-4ad4-9fe2-03a71098332b 55700-536 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 Lake Erie Medical DBA Quality Care Products LLC INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-537_2bfb7067-a367-4ad4-9fe2-03a71098332b 55700-537 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 Lake Erie Medical DBA Quality Care Products LLC INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-538_3e4b1a47-92b7-48a4-b6a4-e4302d97755c 55700-538 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20090803 ANDA ANDA065373 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 55700-539_c0ca1849-abe2-4adf-a1bd-913bf0eea6c1 55700-539 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 Lake Erie Medical DBA Quality Care Products LLC ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 55700-540_735d2399-6bb7-4b9f-a605-446d045c7a37 55700-540 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20170811 NDA NDA018877 Lake Erie Medical DBA Quality Care Products LLC ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 55700-541_5b03c756-9328-4e41-9469-33a29005ac5a 55700-541 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20170811 ANDA ANDA078925 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55700-542_557b54d0-9966-412b-b994-fe08ff4ad3cb 55700-542 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55700-543_5b03c756-9328-4e41-9469-33a29005ac5a 55700-543 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20170811 ANDA ANDA078925 Lake Erie Medical DBA Quality Care Products LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 55700-544_4478dfc0-5e84-45dc-8072-ea606f083ee3 55700-544 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Lake Erie Medical DBA Quality Care Products LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 55700-545_25d1dafa-a689-4fb3-89f0-d55591c2cb98 55700-545 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170811 ANDA ANDA204662 Lake Erie Medical DBA Quality Care Products LLC POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55700-546_f04ccdc0-afcb-4772-8604-a8efc4254276 55700-546 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20170811 NDA NDA018569 Lake Erie Medical DBA Quality Care Products LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 55700-547_d472b416-48a1-4d87-aba0-8aa7366b47b5 55700-547 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20170811 ANDA ANDA076164 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55700-548_aa4450e3-25a3-4720-8bdf-a9342d4bcf38 55700-548 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20170818 ANDA ANDA091650 Lake Erie Medical DBA Quality Care Products LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55700-549_9dea4db1-ad65-4884-8659-b035fce403a4 55700-549 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20170818 ANDA ANDA077837 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55700-550_9dea4db1-ad65-4884-8659-b035fce403a4 55700-550 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20170818 ANDA ANDA077837 Lake Erie Medical DBA Quality Care Products LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 55700-551_ac7abc1c-2806-400f-ad86-f7d13f8f94a8 55700-551 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20170818 ANDA ANDA077626 Lake Erie Medical DBA Quality Care Products LLC RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55700-552_69995f30-cd2f-4434-b1db-ce30d845b08a 55700-552 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20170818 ANDA ANDA202104 Lake Erie Medical DBA Quality Care Products LLC MORPHINE SULFATE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-553_0ce90e50-4f8d-47d8-a8a4-fc74352bda9b 55700-553 HUMAN OTC DRUG Childrens MAPAP Acetaminophen LIQUID ORAL 20150301 OTC MONOGRAPH NOT FINAL part343 Lake Erie Medical DBA Quality Care Products LLC ACETAMINOPHEN 160 mg/5mL N 20181231 55700-554_ca6de301-52e9-408d-b84c-220fddbca103 55700-554 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide CREAM TOPICAL 20170929 ANDA ANDA073030 Lake Erie Medical DBA Quality Care Products LLC FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55700-555_65acd82a-a85a-4e95-8652-3f287c3436f1 55700-555 HUMAN PRESCRIPTION DRUG Nucynta ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170616 NDA NDA200533 LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 55700-556_d13da6cc-2ee5-4f1c-bba3-94bfd722dfe7 55700-556 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040627 Lake Erie Medical DBA Quality Care Products LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 55700-557_68240be4-abbb-4160-bedb-b057e3da30aa 55700-557 HUMAN PRESCRIPTION DRUG XTAMPZA ER OXYCODONE CAPSULE, EXTENDED RELEASE ORAL 20160510 NDA NDA208090 Lake Erie Medical DBA Quality Care Products LLC OXYCODONE 13.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 55700-558_530be617-adfd-453d-9c6a-2aef3c240fd6 55700-558 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 Lake Erie Medical DBA Quality Care Products LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 55700-559_63e91478-52da-400a-bc19-f9c161c94314 55700-559 HUMAN PRESCRIPTION DRUG DIFLUNISAL DIFLUNISAL TABLET, FILM COATED ORAL 20120501 ANDA ANDA202845 Lake Erie Medical DBA Quality Care Products LLC DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 55700-560_8457e56c-e3d6-4efa-a2cb-0eb093b89d04 55700-560 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Lake Erie Medical DBA Quality Care Products LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 55700-561_f34ad199-1450-42f0-a609-c8f07b5e4ba0 55700-561 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20171117 ANDA ANDA040749 Lake Erie Medical DBA Quality Care Products LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 55700-562_46f2fa1b-f3a1-4002-b79a-acde51a67ff8 55700-562 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 Lake Erie Medical DBA Quality Care Products LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 55700-563_26b0f8ec-a1aa-4115-8176-8be70cbfe733 55700-563 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20070412 ANDA ANDA065326 Lake Erie Medical DBA Quality Care Products LLC CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 55700-564_00a5aaad-0fe6-46f7-9b19-9e6556578443 55700-564 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20171208 ANDA ANDA074569 Lake Erie Medical DBA Quality Care Products LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 55700-565_51034f23-626c-483c-960c-d6346fa0b9cc 55700-565 HUMAN PRESCRIPTION DRUG Nucynta ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170616 NDA NDA200533 Lake Erie Medical DBA Quality Care Products LLC TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 55700-566_51c59e21-1d3f-49b4-a13b-1854233ffe0c 55700-566 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20171215 ANDA ANDA076900 Lake Erie Medical DBA Quality Care Procucts LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-567_51c59e21-1d3f-49b4-a13b-1854233ffe0c 55700-567 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20171215 ANDA ANDA076900 Lake Erie Medical DBA Quality Care Procucts LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 55700-568_671fe384-e9c7-427f-ada9-45f52181788e 55700-568 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20171215 NDA AUTHORIZED GENERIC NDA021306 Lake Erie Medical DBA Quality Care Products LLC BUPRENORPHINE 5 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 55700-569_972b37f5-c2a0-4d01-815f-99562880e7de 55700-569 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20171221 ANDA ANDA077802 Lake Erie Medical DBA Quality Care Products LLC OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 55700-570_1d305af1-795d-4b42-892c-3801985513e7 55700-570 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20171221 ANDA ANDA090540 Lake Erie Medical DBA Quality Care Products LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20191231 55700-571_120e44a1-c2d8-4215-8ebf-22e36eded993 55700-571 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20171221 ANDA ANDA090798 Lake Erie Medical DBA Quality Care Products LLC OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20191231 55700-572_c294dda1-b753-407b-afdf-a2a6e0d955cd 55700-572 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20171221 ANDA ANDA090549 Lake Erie Medical DBA Quality Care Products LLC PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 55700-573_a70e868e-f69c-4b8e-9838-f02893f135d9 55700-573 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170515 ANDA ANDA204170 Lake Erie Medical DBA Quality Care Products LLC ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20191231 55700-574_30656b10-6d1a-46d5-8622-07529a4581a6 55700-574 HUMAN PRESCRIPTION DRUG Rosuvastatin Rosuvastatin TABLET, FILM COATED ORAL 20180105 ANDA ANDA207616 Lake Erie Medical DBA Quality Care Products LLC ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 55700-575_30656b10-6d1a-46d5-8622-07529a4581a6 55700-575 HUMAN PRESCRIPTION DRUG Rosuvastatin Rosuvastatin TABLET, FILM COATED ORAL 20180105 ANDA ANDA207616 Lake Erie Medical DBA Quality Care Products LLC ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 55700-576_3038f35a-0fa3-42e9-a310-c12b602b6c4d 55700-576 HUMAN PRESCRIPTION DRUG glyBURIDE glyBURIDE TABLET ORAL 20180105 ANDA ANDA203581 Lake Erie Medical DBA Quality Care Products LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 55700-577_bf355349-7c24-42bb-ba27-ada5cfa1e07c 55700-577 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine Succinate TABLET, EXTENDED RELEASE ORAL 20180105 ANDA ANDA204003 Lake Erie Medical DBA Quality Care Products LLC DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 55700-578_9b6f69e3-1085-43b0-942e-26d0b3154f05 55700-578 HUMAN PRESCRIPTION DRUG Fexmid Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20180112 ANDA ANDA071611 Lake Erie Medical DBA Quality Care Products LLC CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 55700-579_ccf1b93c-d49f-40b9-9286-2ce35101f67b 55700-579 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine PATCH TRANSDERMAL 20180112 NDA AUTHORIZED GENERIC NDA021306 Lake Erie Medical DBA Quality Care Products LLC BUPRENORPHINE 5 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 55700-580_3c106e7b-2a58-40ce-9a6c-7b94f1341495 55700-580 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20180112 OTC MONOGRAPH FINAL part336 Lake Erie Medical DBA Quality Care Products LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 55700-581_eefddd21-e974-48a4-8be9-7f42764f30d0 55700-581 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20180119 ANDA ANDA202929 Lake Erie Medical DBA Quality Care Products LLC ESZOPICLONE 2 mg/1 CIV N 20191231 55700-582_fb0b41d2-d880-4ce7-84e4-e354ce225e72 55700-582 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20180119 ANDA ANDA201407 Lake Erie Medical DBA Quality Care Products LLC TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 55700-583_dc030306-d681-4dda-b91e-37386dbcf3b0 55700-583 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, COATED ORAL 20180202 ANDA ANDA091024 Lake Erie Medical DBA Quality Care Products LLC ESZOPICLONE 2 mg/1 CIV N 20191231 55711-064_0089cee9-edf4-44ae-96a9-8209b9fb379b 55711-064 HUMAN OTC DRUG Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 10 mg/1 N 20181231 55711-064_2299916d-9864-4176-bc77-fa35a0ed959b 55711-064 HUMAN OTC DRUG Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100908 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 10 mg/1 N 20181231 55711-064_2b1c6c4e-6737-42e4-be82-db5795f3b7f5 55711-064 HUMAN OTC DRUG Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 10 mg/1 N 20181231 55711-064_acbcbc4e-e0dc-45ba-9323-680d4004adea 55711-064 HUMAN OTC DRUG Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 10 mg/1 N 20181231 55711-064_d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf 55711-064 HUMAN OTC DRUG Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 10 mg/1 N 20181231 55711-066_065ef0a6-3490-4a72-80e2-dea7ac1d8c89 55711-066 HUMAN OTC DRUG Sugar Free Refreshing Mint Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 3 mg/1 N 20181231 55711-066_d7c709ed-41fb-4854-b251-f1ebc7c07a78 55711-066 HUMAN OTC DRUG Sugar Free Refreshing Mint Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 3 mg/1 N 20181231 55711-066_f70cfec6-be1f-412a-a8d6-61675e3685d9 55711-066 HUMAN OTC DRUG Sugar Free Refreshing Mint Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 3 mg/1 N 20181231 55711-069_0213ac54-3a68-44b6-b0ef-d603c4a09ba8 55711-069 HUMAN OTC DRUG Low Sugar Cherry Flavor Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 5.75 mg/1 E 20171231 55711-069_12dc2ff7-395f-4e47-82b8-3df48db071f0 55711-069 HUMAN OTC DRUG Low Sugar Cherry Flavor Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 5.75 mg/1 E 20171231 55711-069_27b1977b-ba86-47aa-976d-c5769a7e4b39 55711-069 HUMAN OTC DRUG Low Sugar Cherry Flavor Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100908 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 5.75 mg/1 E 20171231 55711-069_d636d793-1b40-438a-a768-d66be5fff4af 55711-069 HUMAN OTC DRUG Low Sugar Cherry Flavor Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 5.75 mg/1 E 20171231 55711-070_3bfa1bb6-47e0-4931-a0c9-fe5a8c9d57da 55711-070 HUMAN OTC DRUG Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 6.9 mg/1 N 20181231 55711-070_42d4bafb-b630-487e-b63d-13ad37a59454 55711-070 HUMAN OTC DRUG Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 6.9 mg/1 N 20181231 55711-070_71503407-0eb6-4901-9f04-40c9a9e9f788 55711-070 HUMAN OTC DRUG Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant Menthol LOZENGE ORAL 20100810 OTC MONOGRAPH FINAL part341 Lofthouse of Fleetwood, Ltd. MENTHOL 6.9 mg/1 N 20181231 55714-1101_66b237e3-a29b-9415-d2db-0c8a57300d00 55714-1101 HUMAN OTC DRUG Prime Plus Agnus, Allium sativum, Ambra, Angelica sinensis radix, Aralia quinquefolia, Arnica, Arsenicum alb., Avena, Baptisia, Baryta carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux vom., Phosphoricum ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. met., Ginkgo, Ruta, Organic, Cane Dispensing Alcohol LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO; RUTA GRAVEOLENS FLOWERING TOP 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1102_f91a0168-92d4-e0c9-e015-ab05177c3133 55714-1102 HUMAN OTC DRUG Sick Stopper Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo rana, Aconitum nap., Agaricus musc., Aralia quinquefolia, Baptisia, Bryonia, Chelidonium majus, Eupatorium perf., Hepar sulph. calc., Lachesis, Lycopodium, Nux vom., Rhus toxicodendron, Sanguinaria, Sulphur, Thuja occ., Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS 30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1103_b62c5e84-5cbe-1a94-31a5-40c249953525 55714-1103 HUMAN OTC DRUG Swimmers Support Antimon. tart., Arnica, Bellis, Bryonia, Calc. carb., Capsicum, Chelidonium majus, Cuprum met., Digitalis, Drosera, Lachesis, Lacticum acidum, Ledum, Mag. carb., Mang. acet., Nux vom., Phytolacca, Rhus toxicodendron, Ruta, Sarcolacticum ac., Sulphuricum ac., Verbascum, Vipera berus LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1104_926fe9a7-caf2-0995-feb7-f74730131779 55714-1104 HUMAN OTC DRUG Hangover Help Agaricus musc., Arsenicum alb., Bismuthum metallicum, Bryonia, Capsicum, Carbo veg., Glonoinum, Ipecac., Iris versicolor, Laurocerasus, Lycopodium, Mezereum, Nux vom., Pulsatilla, Ranunc. bulb. , Theridion, Veratrum alb., Zinc. met., Zingiber, Chamomilla, Passiflora, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1105_a36044af-cc69-5ca4-22d0-2f284b542ab0 55714-1105 HUMAN OTC DRUG Prime Plus Agnus, Allium sativum, Ambra, Angelica sinensis radix, Aralia quinquefolia, Arnica, Arsenicum alb., Avena, Baptisia, Baryta carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux vom., Phosphoricum ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. met., Ginkgo PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1106_8f0ca02f-b9be-d943-7aeb-4366fc18a0fa 55714-1106 HUMAN OTC DRUG Panic Button Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1108_5ae4b9ed-819c-5db0-e053-2991aa0ac1f3 55714-1108 HUMAN OTC DRUG Sports Recovery Apis mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum acidum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Sarcolacticum ac., Staphysag., Symphytum, Echinacea, Hydrastis LIQUID ORAL 20160725 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1109_5c019a5b-56b9-232d-e053-2a91aa0a966a 55714-1109 HUMAN OTC DRUG Sports Recovery Apis mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum acidum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Sarcolacticum ac., Staphysag., Symphytum, Echinacea, Hydrastis PELLET ORAL 20160725 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1110_e274f180-6d99-2f22-c3a4-be23bc4eb1c0 55714-1110 HUMAN OTC DRUG Jet Lag Alumina, Aralia quinquefolia, Arg. nit., Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Conium, Gelsemium, Iodium, Kali carb., Kali iod., Lycopodium, Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Sabal, Thyroidinum, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALUMINUM OXIDE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1112_ffdf8089-948d-f550-63b0-d126f5fb7f40 55714-1112 HUMAN OTC DRUG Swimmers Support Antimon. tart., Arnica, Bellis, Bryonia, Calc. carb., Capsicum, Chelidonium majus, Cuprum met., Digitalis, Drosera, Lachesis, Lacticum acidum, Ledum, Mag. carb., Mang. acet., Nux vom., Phytolacca, Rhus toxicodendron, Ruta, Sarcolacticum ac., Sulphuricum ac., Verbascum, Vipera berus PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1113_b827d6f1-fec2-b79d-c929-be2b7dd29a18 55714-1113 HUMAN OTC DRUG Hangover Help Agaricus musc., Arsenicum alb., Bismuthum metallicum, Bryonia, Capsicum, Carbo veg., Glonoinum, Ipecac., Iris versicolor, Laurocerasus, Lycopodium, Mezereum, Nux vom., Pulsatilla, Ranunc. bulb. , Theridion, Veratrum alb., Zinc. met., Zingiber, Chamomilla, Passiflora, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1114_74cca58d-d073-b3ce-1474-e3fe6cf1a8e4 55714-1114 HUMAN OTC DRUG Sick Stopper Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo rana, Aconitum nap., Agaricus musc., Aralia quinquefolia, Baptisia, Bryonia, Chelidonium majus, Eupatorium perf., Hepar sulph. calc., Lachesis, Lycopodium, Nux vom., Rhus toxicodendron, Sanguinaria, Sulphur, Thuja occ., Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS 30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1115_dde3fa0b-5ce4-1b03-4d8f-5d1901ba6755 55714-1115 HUMAN OTC DRUG Panic Button Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1118_b8a8592d-20d3-a64d-5ffb-b37e9d175059 55714-1118 HUMAN OTC DRUG Jet Lag Alumina, Aralia quinquefolia, Arg. nit., Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Conium, Gelsemium, Iodium, Kali carb., Kali iod., Lycopodium, Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Sabal, Thyroidinum, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALUMINUM OXIDE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_M]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1500_cb44a5da-f618-339c-d74e-c2c2062e8ff2 55714-1500 HUMAN OTC DRUG Detoxifier Uricum acidum, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Carduus benedictus, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Dolichos, Iris versicolor, Juniperus com., Nux vom., Ptelea, Taraxacum, Carduus mar., Cynara scolymus, Solidago LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. URIC ACID; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1502_6f872ed1-6f81-421e-8843-0ca9aee6c2e7 55714-1502 HUMAN OTC DRUG Sniffles Influenzinum, Aconitum nap., Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procumbens, Gelsemium, Histaminum hydrochloricum, Hydrastis, Kali bic., Lycopodium, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Salvia, Sticta, Thuja occ., Verbascum, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAGE; LOBARIA PULMONARIA; THUJA OCCIDENTALIS LEAFY TWIG; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1503_a99f90e9-d3f8-8fa3-65f8-d531448a33aa 55714-1503 HUMAN OTC DRUG Fever Infection Influenzinum, Aconitum nap., Arsenicum alb., Belladonna, Bryonia, Camphora, Cina, Cinchona, Eupatorium perf., Ferrum phosphoricum, Gelsemium, Hepar sulph. calc., Ignatia, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Salix nigra,Veratrum viride, Chamomilla, Echinacea, Hydrastis. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); ARTEMISIA CINA PRE-FLOWERING TOP; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SALIX NIGRA BARK; VERATRUM VIRIDE ROOT; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; FERROSOFERRIC PHOSPHATE; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1504_db4d230c-b4a2-f034-298d-5d16f5c64935 55714-1504 HUMAN OTC DRUG Ear Care Influenzinum, Tellurium metallicum, Apis mel., Arsenicum alb., Belladonna, Bryonia, Capsicum, austicum, Cinchona, Conium,Dulcamara, Ferrum phosphoricum, Hepar sulph. calc.,Kali sulph., ycopodium, Merc. viv., Mezereum,Phosphorus, Plantago, Pulsatilla, Silicea,Verbascum, Echinacea, Hydrastis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; TELLURIUM; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM SULFATE; LYCOPODIUM CLAVATUM SPORE; MERCURY; DAPHNE MEZEREUM BARK; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILICON DIOXIDE; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1505_577e4bf2-48a3-16fc-e6dc-33d80a5aecb6 55714-1505 HUMAN OTC DRUG Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia, Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc. met., Echinacea, Iris versicolor, Phytolacca, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. PICEA MARIANA RESIN; HORSE CHESTNUT; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; GRAPHITE; GOLDENSEAL; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; FRANGULA PURSHIANA BARK; SANICULA EUROPAEA LEAF; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1506_12bdabc8-66da-ae87-c873-826c5ab46bd6 55714-1506 HUMAN OTC DRUG Allergies Cow milk, Skim milk, Cow milk fat, Casein Lactococcus Lactis cultured, Casein lactococcus lactis penicilium roqueforti cultured, Casein lactococcus lactis cultured penicillium camemberti cultured, Egg, Felis catus skin, Canis lupus familiaris skin, Orysctolagus cuniculus skin, Equus caballus skin, Serinus canaria feather, gallus gallus feather, Anas platyrhynchos feather, Anser anser feather, melopsittacus undulatus feather, Phasianus colchicus feather, Meleagris gallopavo feather, Felis catus hair LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. COW MILK; SKIM MILK; COW MILK FAT; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; EGG; FELIS CATUS SKIN; ORYCTOLAGUS CUNICULUS SKIN; EQUUS CABALLUS SKIN; SERINUS CANARIA FEATHER; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; MELOPSITTACUS UNDULATUS FEATHER; PHASIANUS COLCHICUS FEATHER; MELEAGRIS GALLOPAVO FEATHER; FELIS CATUS HAIR; HUMAN DANDER; CANIS LUPUS FAMILIARIS HAIR; EQUUS CABALLUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; HUMAN HAIR; HUMAN SKIN; SHEEP WOOL; BOS TAURUS HAIR; CAPRA HIRCUS HAIR; CAVIA PORCELLUS HAIR; MESOCRICETUS AURATUS HAIR; FD&C YELLOW NO. 5; D&C YELLOW NO. 10; FD&C YELLOW NO. 6; CARMOISINE; AMARANTH; PONCEAU 4R; FD&C RED NO. 3; ACID RED 1; FD&C BLUE NO. 2; SODIUM COPPER CHLOROPHYLLIN; ACID GREEN 50; SODIUM BENZOATE; POTASSIUM BENZOATE; PROPYLPARABEN; SODIUM DITHIONATE; 2-PHENYLPHENOL; SODIUM NITRITE; ASCORBIC ACID; SODIUM TRIPOLYPHOSPHATE; ASPARTAME; MONOSODIUM GLUTAMATE; BARLEY; CORN; WHEAT GLUTEN; OAT; WHITE RICE; RYE; WHEAT; BEEF; PORK; LAMB; CHICKEN; TURKEY; QUAHOG, UNSPECIFIED; CRAB LEG, UNSPECIFIED; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; SCALLOP, UNSPECIFIED; XEROPHYLLUM ASPHODELOIDES; AETHUSA CYNAPIUM; ALFALFA; ALETRIS FARINOSA ROOT; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; DYSPHANIA AMBROSIOIDES; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PTELEA TRIFOLIATA BARK; SAMBUCUS NIGRA FLOWERING TOP; TRILLIUM ERECTUM ROOT; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; YUCCA FILAMENTOSA; ACONITUM NAPELLUS; ARUNDO PLINIANA ROOT; HELIANTHEMUM CANADENSE; DROSERA ROTUNDIFOLIA; SOLANUM DULCAMARA TOP; LEDUM PALUSTRE TWIG; ONOSMODIUM VIRGINIANUM WHOLE; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; DATURA STRAMONIUM; ATROPA BELLADONNA; CAPSICUM; HYOSCYAMUS NIGER; SOLANUM NIGRUM WHOLE; TOBACCO LEAF; AMANITA MUSCARIA FRUITING BODY; ONION; GARLIC; ANACARDIUM OCCIDENTALE FRUIT; LYCOPERDON UTRIFORME FRUITING BODY; CAFFEINE; CINNAMON; CYNARA SCOLYMUS LEAF; ALPINE STRAWBERRY; ABRUS PRECATORIUS SEED; GLYCYRRHIZA GLABRA; MENTHA PIPERITA; NUTMEG; LACTOSE; SUCROSE; BLACK MUSTARD SEED; ALLYLTHIOUREA; USTILAGO MAYDIS; GINGER; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM HERBARUM; BRAZIL NUT; HAZELNUT, UNSPECIFIED; PEANUT; ENGLISH WALNUT; TROUT, UNSPECIFIED; COD, UNSPECIFIED; HADDOCK; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; HERRING, UNSPECIFIED; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; HOUSE DUST; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; BROMINE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POTASSIUM IODIDE; SOLANUM LYCOPERSICUM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SACCHARIN; SOLANUM TUBEROSUM; SULFUR; SACCHAROMYCES CEREVISIAE; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; TARAXACUM OFFICINALE; ALOPECURUS PRATENSIS POLLEN; PRIMULA VULGARIS 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1508_13bd63e7-32cd-b272-1e7c-3fe49c04fa45 55714-1508 HUMAN OTC DRUG Tummy Upset Bismuthum metallicum, Aloe, Angelica sinensis radix, Antimon. crud., Arg. nit., Arnica, Arsenicum alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. carb., Nux vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MYRRH; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; GINGER; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1509_eb10e98e-a6c0-5815-f9ab-fb5b366db85b 55714-1509 HUMAN OTC DRUG Teething - Colic Aconitum nap., Apis mel., Baptisia, Belladonna, Borax, Bryonia, Calc. carb., Calc. phos., Chamomilla, Chelidonium majus, Coffea cruda, Collinsonia, Colocynthis, Kreosotum, Mag.phos., Nux vom., Podoph. pelt., Rheum, Scutellarialateriflora, Silicea, Terebinthina, Zingiber, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; BAPTISIA TINCTORIA; ATROPA BELLADONNA; SODIUM BORATE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; ARABICA COFFEE BEAN; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; WOOD CREOSOTE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; RHEUM OFFICINALE ROOT; SCUTELLARIA LATERIFLORA; SILICON DIOXIDE; TURPENTINE OIL; GINGER; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1511_e59064e0-9029-05c9-5a1c-9dd351c83670 55714-1511 HUMAN OTC DRUG Diarrhea Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Carbo veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris versicolor, Lycopodium, Mag. carb., Phosphorus, Podoph. pelt., Rheum, Sulphur, Tabacum, Vaccinium, Aesculus hipp. Juglans regia, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; PHOSPHORUS; PODOPHYLLUM; RHEUM OFFICINALE WHOLE; SULFUR; TOBACCO LEAF; BILBERRY; HORSE CHESTNUT; JUGLANS REGIA WHOLE; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1512_0d6cb12f-e6d8-ff12-7cd7-dd541ac99218 55714-1512 HUMAN OTC DRUG Bangs Scrapes Aconitum nap., Arnica, Bellis, Calendula, Echinacea, Gelsemium, Hamamelis, Hypericum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; GOLDENSEAL 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1513_3f5f4fa9-1125-a5dd-d7c5-69c91fa184fe 55714-1513 HUMAN OTC DRUG Bedwetting Belladonna, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Humulus, Kali phos., Lycopodium, Nat.mur., Plantago, Pulsatilla, Rhus aromatica, Sabal, Thyroidinum, Verbascum, Echinacea, Hydrastis, Passiflora, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ATROPA BELLADONNA; LYTTA VESICATORIA; CAUSTICUM; EQUISETUM HYEMALE; IRON; GELSEMIUM SEMPERVIRENS ROOT; HOPS; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; RHUS AROMATICA ROOT BARK; SAW PALMETTO; THYROID, UNSPECIFIED; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1514_d8fec694-b6b1-555c-f73d-4e8f0408b13d 55714-1514 HUMAN OTC DRUG Hypercalm - Mental Focus Adrenalinum, Tarentula cubensis, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Coffea cruda, Cypripedium, Digitalis, Gelsemium, Humulus, Hyoscyamus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Veratrum viride, Echinacea, Hypericum, Passiflora LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; CITHARACANTHUS SPINICRUS; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SCUTELLARIA LATERIFLORA; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THERIDION CURASSAVICUM; VERATRUM VIRIDE ROOT; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM; PASSIFLORA INCARNATA FLOWERING TOP 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1516_811f7fc0-0dd1-d819-d502-6986772aaafc 55714-1516 HUMAN OTC DRUG Bowel Digestive Care Bismuthum metallicum, Antimon.crud., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; IRIS VERSICOLOR ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; DAIKON; TOXICODENDRON PUBESCENS LEAF; TOBACCO LEAF; VERBASCUM THAPSUS; GINGER; ECHINACEA, UNSPECIFIED; JUGLANS REGIA LEAF 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1517_60b6a49a-4c03-90b6-e053-2a91aa0a5f7b 55714-1517 HUMAN OTC DRUG Vaccination - Illness Influenzinum, Morbillinum, Pertussinum, Aconitum nap., Alumina, Antimon. tart., Arsenicum alb., Baptisia, Belladonna, Bryonia, Cinchona, Crotalus horridus, Gelsemium, Kali bic., Lachesis, Ledum, Merc. viv., Mezereum, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Silicea, Sulphur, Thuja occ., Vaccinium, Apis mel., Echinacea, Hypericum LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; ACONITUM NAPELLUS; ALUMINUM OXIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; MERCURY; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; BILBERRY; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM 30; 30; 30; 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1518_5c6222ae-ddad-848a-e053-2991aa0abc5c 55714-1518 HUMAN OTC DRUG Airway Ease Influenzinum, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb., Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phosphorus, Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago farfara, Verbascum, Echinacea, Lappa. LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA FLOWERING TOP; EUCALYPTUS GLOBULUS LEAF; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; POTASSIUM IODIDE; MYRRH; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; TUSSILAGO FARFARA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-1700_b09e73ad-b019-a255-545d-a1240fd8394c 55714-1700 HUMAN OTC DRUG Detoxifier Uricum acidum, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Carduus benedictus, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Dolichos, Iris versicolor, Juniperus com., Nux vom., Ptelea, Taraxacum, Carduus mar., Cynara scolymus, Solidago PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. URIC ACID; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1702_21ef99ec-5154-0951-5d6f-3c02dbcb3932 55714-1702 HUMAN OTC DRUG Sniffles Influenzinum, Aconitum nap., Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procumbens, Gelsemium, Histaminum hydrochloricum, Hydrastis, Kali bic., Lycopodium, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Salvia, Sticta, Thuja occ., Verbascum, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAGE; LOBARIA PULMONARIA; THUJA OCCIDENTALIS LEAFY TWIG; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1703_727785e6-1e8e-102b-c648-7f20cd14759c 55714-1703 HUMAN OTC DRUG Fever Infection Influenzinum, Aconitum nap., Arsenicum alb., Belladonna, Bryonia, Camphora, Cina, Cinchona, Eupatorium perf., Ferrum phosphoricum, Gelsemium, Hepar sulph. calc., Ignatia, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Salix nigra,Veratrum viride, Chamomilla, Echinacea, Hydrastis. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); ARTEMISIA CINA PRE-FLOWERING TOP; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SALIX NIGRA BARK; VERATRUM VIRIDE ROOT; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; FERROSOFERRIC PHOSPHATE; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 15; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1704_7250cac6-2d4e-0785-c5ff-3ce7cc21a4e0 55714-1704 HUMAN OTC DRUG Ear Care Influenzinum, Tellurium metallicum, Apis mel., Arsenicum alb., Belladonna, Bryonia, Capsicum, austicum, Cinchona, Conium,Dulcamara, Ferrum phosphoricum, Hepar sulph. calc.,Kali sulph., ycopodium, Merc. viv., Mezereum,Phosphorus, Plantago, Pulsatilla, Silicea,Verbascum, Echinacea, Hydrastis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; TELLURIUM; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM SULFATE; LYCOPODIUM CLAVATUM SPORE; MERCURY; DAPHNE MEZEREUM BARK; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILICON DIOXIDE; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1705_95d693a8-616b-557b-ed62-e4f99048c4f4 55714-1705 HUMAN OTC DRUG Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia, Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc. met., Echinacea, Iris versicolor, Phytolacca, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. PICEA MARIANA RESIN; HORSE CHESTNUT; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; GRAPHITE; GOLDENSEAL; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; FRANGULA PURSHIANA BARK; SANICULA EUROPAEA LEAF; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1706_7658fa09-5173-8030-c990-f011fa889a22 55714-1706 HUMAN OTC DRUG Allergies Cow milk, Skim milk, Cow milk fat, Casein Lactococcus Lactis cultured, Casein lactococcus lactis penicilium roqueforti cultured, Casein lactococcus lactis cultured penicillium camemberti cultured, Egg, Felis catus skin, Canis lupus familiaris skin, Orysctolagus cuniculus skin, Equus caballus skin, Serinus canaria feather, gallus gallus feather, Anas platyrhynchos feather, Anser anser feather, melopsittacus undulatus feather, Phasianus colchicus feather, Meleagris gallopavo feather, Felis catus hair PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. COW MILK; SKIM MILK; COW MILK FAT; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; EGG; FELIS CATUS SKIN; ORYCTOLAGUS CUNICULUS SKIN; EQUUS CABALLUS SKIN; SERINUS CANARIA FEATHER; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; MELOPSITTACUS UNDULATUS FEATHER; PHASIANUS COLCHICUS FEATHER; MELEAGRIS GALLOPAVO FEATHER; FELIS CATUS HAIR; HUMAN DANDER; CANIS LUPUS FAMILIARIS HAIR; EQUUS CABALLUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; HUMAN HAIR; HUMAN SKIN; SHEEP WOOL; BOS TAURUS HAIR; CAPRA HIRCUS HAIR; CAVIA PORCELLUS HAIR; MESOCRICETUS AURATUS HAIR; FD&C YELLOW NO. 5; D&C YELLOW NO. 10; FD&C YELLOW NO. 6; CARMOISINE; AMARANTH; PONCEAU 4R; FD&C RED NO. 3; ACID RED 1; FD&C BLUE NO. 2; SODIUM COPPER CHLOROPHYLLIN; ACID GREEN 50; SODIUM BENZOATE; POTASSIUM BENZOATE; PROPYLPARABEN; SODIUM DITHIONATE; 2-PHENYLPHENOL; SODIUM NITRITE; ASCORBIC ACID; SODIUM TRIPOLYPHOSPHATE; ASPARTAME; MONOSODIUM GLUTAMATE; BARLEY; CORN; WHEAT GLUTEN; OAT; WHITE RICE; RYE; WHEAT; BEEF; PORK; LAMB; CHICKEN; TURKEY; QUAHOG, UNSPECIFIED; CRAB LEG, UNSPECIFIED; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; SCALLOP, UNSPECIFIED; XEROPHYLLUM ASPHODELOIDES; AETHUSA CYNAPIUM; ALFALFA; ALETRIS FARINOSA ROOT; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; DYSPHANIA AMBROSIOIDES; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PTELEA TRIFOLIATA BARK; SAMBUCUS NIGRA FLOWERING TOP; TRILLIUM ERECTUM ROOT; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; YUCCA FILAMENTOSA; ACONITUM NAPELLUS; ARUNDO PLINIANA ROOT; HELIANTHEMUM CANADENSE; DROSERA ROTUNDIFOLIA; SOLANUM DULCAMARA TOP; LEDUM PALUSTRE TWIG; ONOSMODIUM VIRGINIANUM WHOLE; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; DATURA STRAMONIUM; ATROPA BELLADONNA; CAPSICUM; HYOSCYAMUS NIGER; SOLANUM NIGRUM WHOLE; TOBACCO LEAF; AMANITA MUSCARIA FRUITING BODY; ONION; GARLIC; ANACARDIUM OCCIDENTALE FRUIT; LYCOPERDON UTRIFORME FRUITING BODY; CAFFEINE; CINNAMON; CYNARA SCOLYMUS LEAF; ALPINE STRAWBERRY; ABRUS PRECATORIUS SEED; GLYCYRRHIZA GLABRA; MENTHA PIPERITA; NUTMEG; LACTOSE; BLACK MUSTARD SEED; ALLYLTHIOUREA; USTILAGO MAYDIS; GINGER; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM HERBARUM; BRAZIL NUT; HAZELNUT, UNSPECIFIED; PEANUT; ENGLISH WALNUT; TROUT, UNSPECIFIED; COD, UNSPECIFIED; HADDOCK; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; HERRING, UNSPECIFIED; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; HOUSE DUST; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; BROMINE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POTASSIUM IODIDE; SOLANUM LYCOPERSICUM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SACCHARIN; SOLANUM TUBEROSUM; SULFUR; SACCHAROMYCES CEREVISIAE; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; TARAXACUM OFFICINALE; ALOPECURUS PRATENSIS POLLEN; PRIMULA VULGARIS 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1708_65233e08-e8e1-fe57-9de2-902cc6efef3e 55714-1708 HUMAN OTC DRUG Tummy Upset Bismuthum metallicum, Aloe, Angelica sinensis radix, Antimon. crud., Arg. nit., Arnica, Arsenicum alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. carb., Nux vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MYRRH; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; GINGER; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1709_13ed5ab9-9b6e-2be1-1e67-09213578f9f0 55714-1709 HUMAN OTC DRUG Teething - Colic Aconitum nap., Apis mel., Baptisia, Belladonna, Borax, Bryonia, Calc. carb., Calc. phos., Chamomilla, Chelidonium majus, Coffea cruda, Collinsonia, Colocynthis, Kreosotum, Mag.phos., Nux vom., Podoph. pelt., Rheum, Scutellarialateriflora, Silicea, Terebinthina, Zingiber, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; BAPTISIA TINCTORIA; ATROPA BELLADONNA; SODIUM BORATE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; ARABICA COFFEE BEAN; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; WOOD CREOSOTE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; RHEUM OFFICINALE ROOT; SCUTELLARIA LATERIFLORA; SILICON DIOXIDE; TURPENTINE OIL; GINGER; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1711_8215a2cb-ba70-0174-8c66-8aa5088698ee 55714-1711 HUMAN OTC DRUG Diarrhea Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Carbo veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris versicolor, Lycopodium, Mag. carb., Phosphorus, Podoph. pelt., Rheum, Sulphur, Tabacum, Vaccinium, Aesculus hipp. Juglans regia, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; PHOSPHORUS; PODOPHYLLUM; RHEUM OFFICINALE WHOLE; SULFUR; TOBACCO LEAF; BILBERRY; HORSE CHESTNUT; JUGLANS REGIA WHOLE; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1712_685ecea9-1343-6eb1-682a-740a80469f59 55714-1712 HUMAN OTC DRUG Bangs Scrapes Aconitum nap., Arnica, Bellis, Calendula, Echinacea, Gelsemium, Hamamelis, Hypericum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; GOLDENSEAL 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1713_13c1764a-6fa3-af12-79bf-96d99b1afb45 55714-1713 HUMAN OTC DRUG Bedwetting Belladonna, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Humulus, Kali phos., Lycopodium, Nat.mur., Plantago, Pulsatilla, Rhus aromatica, Sabal, Thyroidinum, Verbascum, Echinacea, Hydrastis, Passiflora, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ATROPA BELLADONNA; LYTTA VESICATORIA; CAUSTICUM; EQUISETUM HYEMALE; IRON; GELSEMIUM SEMPERVIRENS ROOT; HOPS; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; RHUS AROMATICA ROOT BARK; SAW PALMETTO; THYROID, UNSPECIFIED; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1714_78ce7f38-fcf7-fa7d-a5ea-36be6a3940f5 55714-1714 HUMAN OTC DRUG Hypercalm - Mental Focus Adrenalinum, Tarentula cubensis, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Coffea cruda, Cypripedium, Digitalis, Gelsemium, Humulus, Hyoscyamus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Veratrum viride, Echinacea, Hypericum, Passiflora PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; CITHARACANTHUS SPINICRUS; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SCUTELLARIA LATERIFLORA; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THERIDION CURASSAVICUM; VERATRUM VIRIDE ROOT; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM; PASSIFLORA INCARNATA FLOWERING TOP 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1716_d920a705-8253-2ac4-f81c-33279d0bac9f 55714-1716 HUMAN OTC DRUG Bowel Digestive Care Bismuthum metallicum, Antimon.crud., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; IRIS VERSICOLOR ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; DAIKON; TOXICODENDRON PUBESCENS LEAF; TOBACCO LEAF; VERBASCUM THAPSUS; GINGER; ECHINACEA, UNSPECIFIED; JUGLANS REGIA LEAF 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1717_60b8c5bc-4b93-406e-e053-2a91aa0a8c0c 55714-1717 HUMAN OTC DRUG Vaccination - Illness Influenzinum, Morbillinum, Pertussinum, Aconitum nap., Alumina, Antimon. tart., Arsenicum alb., Baptisia, Belladonna, Bryonia, Cinchona, Crotalus horridus, Gelsemium, Kali bic., Lachesis, Ledum, Merc. viv., Mezereum, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Silicea, Sulphur, Thuja occ., Vaccinium, Apis mel., Echinacea, Hypericum PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; ACONITUM NAPELLUS; ALUMINUM OXIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; MERCURY; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; BILBERRY; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM 30; 30; 30; 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-1718_5c6453b0-b6e5-4959-e053-2a91aa0a3eb7 55714-1718 HUMAN OTC DRUG Airway Ease Influenzinum, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb., Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phosphorus, Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago farfara, Verbascum, Echinacea, Lappa. PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA FLOWERING TOP; EUCALYPTUS GLOBULUS LEAF; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; POTASSIUM IODIDE; MYRRH; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; TUSSILAGO FARFARA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2001_9146c189-b164-3d6e-5e36-60e30677db72 55714-2001 HUMAN OTC DRUG Trauma Cream Hepar sulph. calc., Hypericum, Phosphorus, Aconitum nap., Arnica, Belladonna, Bellis, Calendula, Colchicum, Ledum, Millefolium, Rhus toxicodendron, Apis mel., Chamomilla, Echinacea, Hamamelis, Hydrastis, Ruta, Symphytum CREAM TOPICAL 20130611 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CALCIUM SULFIDE; HYPERICUM PERFORATUM; PHOSPHORUS; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COLCHICUM AUTUMNALE BULB; LEDUM PALUSTRE TWIG; ACHILLEA MILLEFOLIUM; TOXICODENDRON PUBESCENS LEAF; APIS MELLIFERA; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; GOLDENSEAL; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 10; 10; 10; 8; 8; 8; 8; 8; 8; 8; 8; 8; 3; 3; 3; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2002_2516f3a1-9f13-a31e-5ad0-bd5f4664a7b4 55714-2002 HUMAN OTC DRUG Hemorrhoid Cream Aloe, Arsenicum alb., Calc. fluor., Collinsonia, Crotalus horridus, Hydrofluoricum acidum, Lachesis, Lycopodium, Nux vom., Ratanhia, Vipera berus, Aesculus hipp., Calendula, Echinacea, Hamamelis, Hypericum, Solidago, Urtica ur. CREAM TOPICAL 20130801 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ARSENIC TRIOXIDE; CALCIUM FLUORIDE; COLLINSONIA CANADENSIS ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; KRAMERIA LAPPACEA ROOT; VIPERA BERUS VENOM; HORSE CHESTNUT; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; SOLIDAGO VIRGAUREA FLOWERING TOP; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2003_d6554828-640f-4b4e-03d1-cf7bc40b378a 55714-2003 HUMAN OTC DRUG Bee - Bug Bite Pulex irritans, Tarentula cubensis, Apis mel., Aranea diadema, Arnica, Formica, Grindelia, Hypericum, Lachesis, Latrodectus mactans, Ledum, Lycopodium, Mezereum, Rhus toxicodendron, Tarentula hispana, Theridion, Vespa crabro, Calendula, Echinacea, Hamamelis, Solidago CREAM TOPICAL 20130801 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. PULEX IRRITANS; CITHARACANTHUS SPINICRUS; APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; LYCOSA TARANTULA; THERIDION CURASSAVICUM; VESPA CRABRO; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2005_8beb84de-4842-4cac-9118-6d33fa64b1d9 55714-2005 HUMAN OTC DRUG Arnica Cream Arnica montana CREAM TOPICAL 20130801 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARNICA MONTANA 60 [hp_X]/g N 20181231 55714-2200_f47838bd-542f-8185-add9-c0c4d8060efc 55714-2200 HUMAN OTC DRUG Detoxifier Uricum acidum, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Carduus benedictus, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Dolichos, Iris versicolor, Juniperus com., Nux vom.,Ptelea,Taraxacum, Carduus mar., Cynara scolymus, Solidago,Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. URIC ACID; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CNICUS BENEDICTUS; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2201_4d2352c7-8ba2-3d1c-a2dd-aac7156057ac 55714-2201 HUMAN OTC DRUG Detoxifier Uricum acidum, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Carduus benedictus, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Dolichos, Iris versicolor, Juniperus com., Nux vom.,Ptelea,Taraxacum, Carduus mar., Cynara scolymus, Solidago PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. URIC ACID; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2204_54ad4ff3-4971-9a2d-f8b9-bc33bb268758 55714-2204 HUMAN OTC DRUG Cold - Sinus Influenza A Virus, Influenza B Virus, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procubens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SAGE; LOBARIA PULMONARIA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2205_b2cbd0bb-ebab-ae20-ab3f-a612c0cc81bd 55714-2205 HUMAN OTC DRUG Cold - Sinus Influenza A Virus, Influenza B Virus, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procubens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SAGE; LOBARIA PULMONARIA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 30 [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2206_145b2b8f-93c5-a368-58f7-813af13f5fd0 55714-2206 HUMAN OTC DRUG Fever - Infection Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Aconitum nap., Antimon. tart., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Cinchona, Eupatorium perf., Ferrum metallicum, Gelsemium, Hepar sulph.calc., Iodium, Lachesis, Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Salix nigra, Verbascum, Apis mel., Echinacea, Hydrastis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SALIX NIGRA BARK; VERBASCUM THAPSUS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS 30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2207_d6d0089c-c96d-9853-a529-ae94e76db4f5 55714-2207 HUMAN OTC DRUG Fever - Infection Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Aconitum nap., Antimon. tart., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Cinchona, Eupatorium perf., Ferrum metallicum, Gelsemium, Hepar sulph.calc., Iodium, Lachesis, Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Salix nigra, Verbascum, Apis mel., Echinacea, Hydrastis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SALIX NIGRA BARK; VERBASCUM THAPSUS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS 30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2208_d9a9c624-f191-4003-76e4-a0fbb1ab7c0a 55714-2208 HUMAN OTC DRUG Flu Care Influenza A Virus, Influenza B Virus, Histaminum hydrochloricum, Aconitum nap., Aralia quinquefolia, Arsenicum alb., Baptisia, Bryonia, Cinchona, Eupatorium perf., Gelsemium, Ipecac., Kali carb., Nux vom., Phosphorus, Rhus toxicodendron, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; INFLUENZA B VIRUS; HISTAMINE DIHYDROCHLORIDE; ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; ECHINACEA, UNSPECIFIED 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2209_d0f6f2f6-08c2-7858-3390-7bac99a3ee25 55714-2209 HUMAN OTC DRUG Flu Care Influenza A Virus, Influenza B Virus, Histaminum hydrochloricum, Aconitum nap., Aralia quinquefolia, Arsenicum alb., Baptisia, Bryonia, Cinchona, Eupatorium perf., Gelsemium, Ipecac., Kali carb., Nux vom., Phosphorus, Rhus toxicodendron, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; INFLUENZA B VIRUS; HISTAMINE DIHYDROCHLORIDE; ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; ECHINACEA, UNSPECIFIED 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2210_f7907f9b-497a-eeb7-c00e-18df28640c7e 55714-2210 HUMAN OTC DRUG Ear Care Influenzinum, Tellurium metallicum, Apis mel., Arsenicum alb., Belladonna, Bryonia, Capsicum, Causticum, Cinchona, Conium, Dulcamara, Ferrum phosphoricum, Hepar sulph. calc.,Kali sulph., Lycopodium, Merc. viv., Mezereum, Phosphorus, Plantago, Pulsatilla, Silicea, Verbascum, Echinacea, Hydrastis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; TELLURIUM; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM SULFATE; LYCOPODIUM CLAVATUM SPORE; MERCURY; DAPHNE MEZEREUM BARK; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILICON DIOXIDE; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2211_85195ea2-4a34-d6e5-ea1c-c3517b09f4aa 55714-2211 HUMAN OTC DRUG Ear Care Influenzinum, Tellurium metallicum, Apis mel., Arsenicum alb., Belladonna, Bryonia, Capsicum, Causticum, Cinchona, Conium, Dulcamara, Ferrum phosphoricum, Hepar sulph. calc.,Kali sulph., Lycopodium, Merc. viv., Mezereum, Phosphorus, Plantago, Pulsatilla, Silicea, Verbascum, Echinacea, Hydrastis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; TELLURIUM; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM SULFATE; LYCOPODIUM CLAVATUM SPORE; MERCURY; DAPHNE MEZEREUM BARK; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILICON DIOXIDE; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2212_84667426-1e7c-94f3-ed14-808c1ec2877e 55714-2212 HUMAN OTC DRUG Hay Fever Zerophyllum asphodeloides, Alfalfa, Avena sativa pollen, Cynosurus cristatus pollen, Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen, Alopecurus pratensis pollen, Phleum pratense pollen, Festuca pratensis pollen, Holcus lanatus pollen, Lolium perenne pollen, Fagus sylvatica pollen, Betula pendula pollen, Quercus alba pollen, Fraxinus excelsior pollen, Corylus americana pollen, Populus nigra pollen LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. XEROPHYLLUM ASPHODELOIDES; ALFALFA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; ACONITUM NAPELLUS; ARUNDO PLINIANA ROOT; DYSPHANIA AMBROSIOIDES; HELIANTHEMUM CANADENSE; DROSERA ROTUNDIFOLIA; SOLANUM DULCAMARA TOP; LEDUM PALUSTRE TWIG; ONOSMODIUM VIRGINIANUM WHOLE; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; DATURA STRAMONIUM; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; ONION; AMBROSIA ARTEMISIIFOLIA; AMMONIUM CARBONATE; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; TRILLIUM ERECTUM ROOT; USTILAGO MAYDIS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; TARAXACUM OFFICINALE 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2213_f9159ed6-233e-a6bd-3c68-4e498ef8d56b 55714-2213 HUMAN OTC DRUG Hay Fever Zerophyllum asphodeloides, Alfalfa, Avena sativa pollen, Cynosurus cristatus pollen, Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen, Alopecurus pratensis pollen, Phleum pratense pollen, Festuca pratensis pollen, Holcus lanatus pollen, Lolium perenne pollen, Fagus sylvatica pollen, Betula pendula pollen, Quercus alba pollen, Fraxinus excelsior pollen, Corylus americana pollen, Populus nigra pollen PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. XEROPHYLLUM ASPHODELOIDES; ALFALFA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; ACONITUM NAPELLUS; ARUNDO PLINIANA ROOT; DYSPHANIA AMBROSIOIDES; HELIANTHEMUM CANADENSE; DROSERA ROTUNDIFOLIA; SOLANUM DULCAMARA TOP; LEDUM PALUSTRE TWIG; ONOSMODIUM VIRGINIANUM WHOLE; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; DATURA STRAMONIUM; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; ONION; AMBROSIA ARTEMISIIFOLIA; AMMONIUM CARBONATE; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; TRILLIUM ERECTUM ROOT; USTILAGO MAYDIS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; TARAXACUM OFFICINALE 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2214_8000590d-d626-8597-97c5-945c44c38228 55714-2214 HUMAN OTC DRUG Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia , Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc.met., Echinacea, Iris versicolor, Phytolacca, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. PICEA MARIANA RESIN; HORSE CHESTNUT; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; GRAPHITE; GOLDENSEAL; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; FRANGULA PURSHIANA BARK; SANICULA EUROPAEA LEAF; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2215_1ee631ce-1ae4-030a-8ddf-e911d0eb097d 55714-2215 HUMAN OTC DRUG Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia , Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc.met., Echinacea, Iris versicolor, Phytolacca, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. PICEA MARIANA RESIN; HORSE CHESTNUT; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; GRAPHITE; GOLDENSEAL; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; FRANGULA PURSHIANA BARK; SANICULA EUROPAEA LEAF; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2216_4d6fdfdb-fe73-450a-cfe8-cec6fc35ec5a 55714-2216 HUMAN OTC DRUG Rheumatic Joint Care Uricum acidum, Aconitum nap.,Apis mel., Arnica, Arsenicum alb, Belladonna,Benzoicum acidum, Bryonia, Calc. carb., Chamomilla, Cinchona, Colchicum, Eupatorium perf., Gaultheriaprocumbens, Guaiacum, Iodium, Kali bic, Kalmia,Ledum, Pulsatilla, Rhus toxicodendron, Ruta,Sabina, Strychninum, Lappa, Phytolacca, Symphytum, LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. URIC ACID; ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; EUPATORIUM PERFOLIATUM FLOWERING TOP; GAULTHERIA PROCUMBENS TOP; GUAIACUM OFFICINALE RESIN; IODINE; POTASSIUM DICHROMATE; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; JUNIPERUS SABINA LEAFY TWIG; STRYCHNINE; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2217_e3670da3-03f6-4bed-4561-f244b9fa1df9 55714-2217 HUMAN OTC DRUG Rheumatic - Joint Care Uricum acidum, Aconitum nap.,Apis mel., Arnica, Arsenicum alb, Belladonna,Benzoicum acidum, Bryonia, Calc. carb., Chamomilla, Cinchona, Colchicum, Eupatorium perf., Gaultheriaprocumbens, Guaiacum, Iodium, Kali bic, Kalmia,Ledum, Pulsatilla, Rhus toxicodendron, Ruta,Sabina, Strychninum, Lappa, Phytolacca, Symphytum, PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. URIC ACID; ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; EUPATORIUM PERFOLIATUM FLOWERING TOP; GAULTHERIA PROCUMBENS TOP; GUAIACUM OFFICINALE RESIN; IODINE; POTASSIUM DICHROMATE; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; JUNIPERUS SABINA LEAFY TWIG; STRYCHNINE; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2218_2482a5ff-c152-dc04-40f7-40b3a14821ee 55714-2218 HUMAN OTC DRUG Bladder - Kidney Apis mel., Berber. vulg., Bryonia, Cantharis, Cinchona, Equisetum hyemale, Ferrum phosphoricum, Gelsemium, Juniperus com., Pareira, Phosphorus, Plantago, Pulsatilla, Sabal, Terebinthina, Uva-ursi, Echinacea, Hydrastis, Lappa, Solidago LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; EQUISETUM HYEMALE; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; CHONDRODENDRON TOMENTOSUM ROOT; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SAW PALMETTO; TURPENTINE; ARCTOSTAPHYLOS UVA-URSI LEAF; ECHINACEA, UNSPECIFIED; GOLDENSEAL; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2219_372b7f45-a22b-73a6-d32e-3ec0a96bcdc2 55714-2219 HUMAN OTC DRUG Bladder - Kidney Apis mel., Berber. vulg., Bryonia, Cantharis, Cinchona, Equisetum hyemale, Ferrum phosphoricum, Gelsemium, Juniperus com., Pareira, Phosphorus, Plantago, Pulsatilla, Sabal, Terebinthina, Uva-ursi, Echinacea, Hydrastis, Lappa, Solidago PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; EQUISETUM HYEMALE; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; CHONDRODENDRON TOMENTOSUM ROOT; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SAW PALMETTO; TURPENTINE; ARCTOSTAPHYLOS UVA-URSI LEAF; ECHINACEA, UNSPECIFIED; GOLDENSEAL; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2220_ddd495f4-3e48-5b11-5a23-17f6c1d070d8 55714-2220 HUMAN OTC DRUG Hemorrhoids Elaps corallinus, Aesculus hipp., Aloe, Arsenicum alb., Bryonia, Calc. fluor., Capsicum, Collinsonia, Crotalus horridus, Hamamelis, Hydrofluoricum acidum, Hypericum, Lachesis, Lycopodium, Millefolium, Naja, Nux vom., Paeonia, Plantago, Quercus glandium spiritus, Ratanhia, Vipera berus, Echinacea, Solidago, Urtica ur. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; HORSE CHESTNUT; ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAPSICUM; COLLINSONIA CANADENSIS ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROFLUORIC ACID; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; ACHILLEA MILLEFOLIUM; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; PLANTAGO MAJOR; QUERCUS ROBUR NUT; KRAMERIA LAPPACEA ROOT; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; SOLIDAGO VIRGAUREA FLOWERING TOP; URTICA URENS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2221_84365aa1-1068-c019-b6cb-e2688e8b2594 55714-2221 HUMAN OTC DRUG Hemorrhoids Elaps corallinus, Aesculus hipp., Aloe, Arsenicum alb., Bryonia, Calc. fluor., Capsicum, Collinsonia, Crotalus horridus, Hamamelis, Hydrofluoricum acidum, Hypericum, Lachesis, Lycopodium, Millefolium, Naja, Nux vom., Paeonia, Plantago, Quercus glandium spiritus, Ratanhia, Vipera berus, Echinacea, Solidago, Urtica ur. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; HORSE CHESTNUT; ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAPSICUM; COLLINSONIA CANADENSIS ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROFLUORIC ACID; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; ACHILLEA MILLEFOLIUM; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; PLANTAGO MAJOR; QUERCUS ROBUR NUT; KRAMERIA LAPPACEA ROOT; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; SOLIDAGO VIRGAUREA FLOWERING TOP; URTICA URENS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2222_6b236223-d5f5-813b-5de9-2f3e11c9f49b 55714-2222 HUMAN OTC DRUG Menstrual - PMS Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga, Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia,Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; ESTRONE; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; ACHILLEA MILLEFOLIUM; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; CAPSELLA BURSA-PASTORIS; VIBURNUM OPULUS BARK; GINGER; ECHINACEA, UNSPECIFIED; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2223_2c0a0a6b-fb4a-86b4-0da2-dc7de9a191c2 55714-2223 HUMAN OTC DRUG Menstrual - PMS Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga, Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia,Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; ESTRONE; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; ACHILLEA MILLEFOLIUM; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; CAPSELLA BURSA-PASTORIS; VIBURNUM OPULUS BARK; GINGER; ECHINACEA, UNSPECIFIED; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2224_7bf153b1-81d7-9102-9fc7-2165fa2b12a5 55714-2224 HUMAN OTC DRUG Headache Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ.. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; BLACK COHOSH; ARABICA COFFEE BEAN; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; CLAVICEPS PURPUREA SCLEROTIUM; VIPERA BERUS VENOM; APIS MELLIFERA; HYPERICUM PERFORATUM; THUJA OCCIDENTALIS LEAFY TWIG 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2225_222d9bf1-0d40-7e02-8a94-d31d54a7690c 55714-2225 HUMAN OTC DRUG Headache Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ.. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; BLACK COHOSH; ARABICA COFFEE BEAN; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; CLAVICEPS PURPUREA SCLEROTIUM; VIPERA BERUS VENOM; APIS MELLIFERA; HYPERICUM PERFORATUM; THUJA OCCIDENTALIS LEAFY TWIG 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2226_0ba48a10-49f5-bf35-ccca-335bf1b5c4eb 55714-2226 HUMAN OTC DRUG Fungus Fighter Candida albicans, Sanicula, Tellurium metallicum, Torula cerevisiae, Antimon. crud., Arsenicum alb., Baryta carb., Bryonia, Calc. carb., Carbo veg., Cuprum met., Dulcamara, Graphites, Kali carb., Lachesis, Lycopodium, Mezereum, Nitricum ac., Phosphorus, Phytolacca, Sepia, Silicea, Sulphur, Sulphuricum ac., Zinc. met., Apis mel., Thuja occ. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CANDIDA ALBICANS; SANICULA EUROPAEA LEAF; TELLURIUM; SACCHAROMYCES CEREVISIAE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; COPPER; SOLANUM DULCAMARA TOP; GRAPHITE; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; SULFURIC ACID; ZINC; APIS MELLIFERA; THUJA OCCIDENTALIS LEAFY TWIG 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2227_2a3164af-a062-0d52-437a-0132cd16ad1f 55714-2227 HUMAN OTC DRUG Fungus Fighter Candida albicans, Sanicula, Tellurium metallicum, Torula cerevisiae, Antimon. crud., Arsenicum alb., Baryta carb., Bryonia, Calc. carb., Carbo veg., Cuprum met., Dulcamara, Graphites, Kali carb., Lachesis, Lycopodium, Mezereum, Nitricum ac., Phosphorus, Phytolacca, Sepia, Silicea, Sulphur, Sulphuricum ac., Zinc. met., Apis mel., Thuja occ. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CANDIDA ALBICANS; SANICULA EUROPAEA LEAF; TELLURIUM; SACCHAROMYCES CEREVISIAE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; COPPER; SOLANUM DULCAMARA TOP; GRAPHITE; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; SULFURIC ACID; ZINC; APIS MELLIFERA; THUJA OCCIDENTALIS LEAFY TWIG 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2228_ea7493a8-7cb8-4fa3-7ece-6020e794adbf 55714-2228 HUMAN OTC DRUG Acne Antimon. crud., Arsenicum alb., Aur. met., Berber. aqui., Bovista, Carbo veg., Causticum, Chelidonium majus, Dulcamara, Graphites, Hepar sulph. calc., Hydrocotyle, Kali brom., Kali iod., Ledum, Lycopodium, Nux vom., Silicea, Sulphur iod., Zinc. met., Echinacea, Juglans regia, Lappa, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; GOLD; MAHONIA AQUIFOLIUM ROOT BARK; GIANT PUFFBALL; ACTIVATED CHARCOAL; CAUSTICUM; CHELIDONIUM MAJUS; SOLANUM DULCAMARA TOP; GRAPHITE; CALCIUM SULFIDE; CENTELLA ASIATICA; POTASSIUM BROMIDE; POTASSIUM IODIDE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE; SULFUR IODIDE; ZINC; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; ARCTIUM LAPPA ROOT; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2229_b0d315f3-f02b-d0d5-ea42-8feb0c51a836 55714-2229 HUMAN OTC DRUG Acne Antimon. crud., Arsenicum alb., Aur. met., Berber. aqui., Bovista, Carbo veg., Causticum, Chelidonium majus, Dulcamara, Graphites, Hepar sulph. calc., Hydrocotyle, Kali brom., Kali iod., Ledum, Lycopodium, Nux vom., Silicea, Sulphur iod., Zinc. met., Echinacea, Juglans regia, Lappa, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC CATION (3+); GOLD; MAHONIA AQUIFOLIUM ROOT BARK; GIANT PUFFBALL; ACTIVATED CHARCOAL; CAUSTICUM; CHELIDONIUM MAJUS; SOLANUM DULCAMARA TOP; GRAPHITE; CALCIUM SULFIDE; CENTELLA ASIATICA; POTASSIUM BROMIDE; POTASSIUM IODIDE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE; SULFUR IODIDE; ZINC; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; ARCTIUM LAPPA ROOT; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2230_38a82782-b42f-262a-cef9-2af58f786898 55714-2230 HUMAN OTC DRUG Candida - Yeast Adrenalinum, Candida albicans, Thyroidinum, Torula cerevisiae, Triticum, Ustilago maidis, Antimon. crud, Arsenicum alb., Baptisia, Berber. aqui., Bryonia, Calc. phos., Cinchona, Helonias dioica, Hydrastis, Iodium, Iris versicolor, Kali carb., Lachesis, Lycopodium, Merc. viv., Nat.carb., Nat. phos, Nitricum ac., Phosphorus, Podoph. pelt, Pulsatilla, Sepia, Echinacea, Ginkgo, Juglans regia, Lappa, Thuja occ. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; CANDIDA ALBICANS; THYROID, UNSPECIFIED; SACCHAROMYCES CEREVISIAE; ELYMUS REPENS ROOT; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MAHONIA AQUIFOLIUM ROOT BARK; BRYONIA ALBA ROOT; TRIBASIC CALCIUM PHOSPHATE; CINCHONA OFFICINALIS BARK; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; IODINE; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; SODIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NITRIC ACID; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ECHINACEA, UNSPECIFIED; GINKGO; ENGLISH WALNUT; ARCTIUM LAPPA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2231_ef1d8aed-0868-02a5-3d69-708674db6acc 55714-2231 HUMAN OTC DRUG Candida - Yeast Adrenalinum, Candida albicans, Thyroidinum, Torula cerevisiae, Triticum, Ustilago maidis, Antimon. crud, Arsenicum alb., Baptisia, Berber. aqui., Bryonia, Calc. phos., Cinchona, Helonias dioica, Hydrastis, Iodium, Iris versicolor, Kali carb., Lachesis, Lycopodium, Merc. viv., Nat.carb., Nat. phos, Nitricum ac., Phosphorus, Podoph. pelt, Pulsatilla, Sepia, Echinacea, Ginkgo, Juglans regia, Lappa, Thuja occ. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; CANDIDA ALBICANS; THYROID, UNSPECIFIED; SACCHAROMYCES CEREVISIAE; ELYMUS REPENS ROOT; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MAHONIA AQUIFOLIUM ROOT BARK; BRYONIA ALBA ROOT; TRIBASIC CALCIUM PHOSPHATE; CINCHONA OFFICINALIS BARK; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; IODINE; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; SODIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NITRIC ACID; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ECHINACEA, UNSPECIFIED; GINKGO; ENGLISH WALNUT; ARCTIUM LAPPA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2232_494c0f5a-9b21-8cff-5dbf-3a70bc869a8a 55714-2232 HUMAN OTC DRUG Eczema - Skin Care Antimon. crud., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Hepar sulph. calc., Lycopodium, Mezereum, Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur iod., Echinacea, Rumex crisp., Taraxacum, Urtica ur. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULEX IRRITANS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SEPIA OFFICINALIS JUICE; SULFUR IODIDE; ECHINACEA, UNSPECIFIED; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2233_cb6362d0-cacc-9436-ac90-a2a982e15145 55714-2233 HUMAN OTC DRUG Eczema - Skin Care Antimon. crud., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Hepar sulph. calc., Lycopodium, Mezereum, Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur iod., Echinacea, Rumex crisp., Taraxacum, Urtica ur. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULEX IRRITANS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SEPIA OFFICINALIS JUICE; SULFUR IODIDE; ECHINACEA, UNSPECIFIED; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2234_e61c2a0b-f1ff-3747-81a2-21bb534af2a0 55714-2234 HUMAN OTC DRUG Menopause Elaps corallinus, Agnus, Angelica sinensis radix, Arsenicum alb., Bryonia, Cantharis, Caulophyllum, Cimicifuga, Cinchona, Crotalus horridus, Damiana, Glonoinum, Helonias dioica, Ignatia, Kali carb., Lachesis, Naja, Nux vom., Phosphorus, Pulsatilla, Salix nigra, Sanguinaria, Sepia, Echinacea, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; CHASTE TREE; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; TURNERA DIFFUSA LEAFY TWIG; NITROGLYCERIN; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; ECHINACEA, UNSPECIFIED; VALERIAN 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2235_f26cd39b-1c0a-f6cd-1250-169ab3e7654f 55714-2235 HUMAN OTC DRUG Menopause Elaps corallinus, Agnus, Angelica sinensis radix, Arsenicum alb., Bryonia, Cantharis, Caulophyllum, Cimicifuga, Cinchona, Crotalus horridus, Damiana, Glonoinum, Helonias dioica, Ignatia, Kali carb., Lachesis, Naja, Nux vom., Phosphorus, Pulsatilla, Salix nigra, Sanguinaria, Sepia, Echinacea, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; CHASTE TREE; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; TURNERA DIFFUSA LEAFY TWIG; NITROGLYCERIN; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; ECHINACEA, UNSPECIFIED; VALERIAN 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2236_2a43b9d4-f70d-40ad-1719-06e7e8103b7a 55714-2236 HUMAN OTC DRUG Aches - Pains Aconitum nap., Arg. nit., Arnica, Bryonia, Colchicum, Guaiacum, Hypericum, Kalmia, Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Ruta, Sarcolacticum ac., Sticta, Stramonium, Hamamelis, Taraxacum, LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SILVER NITRATE; ARNICA MONTANA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; GUAIAC; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; LOBARIA PULMONARIA; DATURA STRAMONIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2237_9a8589d3-48b0-0b1a-f3c0-255cd9e7afa9 55714-2237 HUMAN OTC DRUG Aches - Pains Aconitum nap., Arg. nit., Arnica, Bryonia, Colchicum, Guaiacum, Hypericum, Kalmia, Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Ruta, Sarcolacticum ac., Sticta, Stramonium, Hamamelis, Taraxacum, PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SILVER NITRATE; ARNICA MONTANA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; GUAIAC; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; LOBARIA PULMONARIA; DATURA STRAMONIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2238_affa5226-f83d-dfe2-2376-3c87e69267d7 55714-2238 HUMAN OTC DRUG Indigestion - Gas Bismuthum metallicum, Aloe, Angelica sinensis radix, Antimon. crud., Arg. nit., Arnica, Arsenicum alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. carb., Nux vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MYRRH; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; GINGER; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2239_c97b712e-1ed9-761c-9ce7-73186d4d2f6b 55714-2239 HUMAN OTC DRUG Indigestion - Gas Bismuthum metallicum, Aloe, Angelica sinensis radix, Antimon. crud., Arg. nit., Arnica, Arsenicum alb., Baptisia, Bryonia, Cinchona, Graphites, Hydrastis, Ipecac., Lachesis, Lycopodium, Myrrha, Nat. carb., Nux vom., Phosphorus, Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; ALOE; ANGELICA SINENSIS ROOT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MYRRH; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; GINGER; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2240_367ae7d0-ec2d-4930-bd02-ddd65c299529 55714-2240 HUMAN OTC DRUG Varicose Veins Elaps corallinus, Crotalus horridus, Bryonia, Calc. fluor., Carduus mar., Cholesterinum, Cinchona, Digitalis, Hamamelis, Hydrofluoricum acidum, Lachesis, Lycopodium, Naja, Pulsatilla, Vipera berus, Zinc. met., Aesculus hipp., Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; CROTALUS HORRIDUS HORRIDUS VENOM; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; SILYBUM MARIANUM SEED; CHOLESTEROL; CINCHONA OFFICINALIS BARK; DIGITALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; NAJA NAJA VENOM; PULSATILLA VULGARIS; VIPERA BERUS VENOM; ZINC; HORSE CHESTNUT; ECHINACEA, UNSPECIFIED 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2241_5d8d0852-0527-53cd-a011-2a2de9f76b49 55714-2241 HUMAN OTC DRUG Varicose Veins Elaps corallinus, Crotalus horridus, Bryonia, Calc. fluor., Carduus mar., Cholesterinum, Cinchona, Digitalis, Hamamelis, Hydrofluoricum acidum, Lachesis, Lycopodium, Naja, Pulsatilla, Vipera berus, Zinc. met., Aesculus hipp., Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; CROTALUS HORRIDUS HORRIDUS VENOM; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; SILYBUM MARIANUM SEED; CHOLESTEROL; CINCHONA OFFICINALIS BARK; DIGITALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; NAJA NAJA VENOM; PULSATILLA VULGARIS; VIPERA BERUS VENOM; ZINC; HORSE CHESTNUT; ECHINACEA, UNSPECIFIED 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2242_00403596-96f3-6bfc-bd1c-f2b602baea49 55714-2242 HUMAN OTC DRUG Prostate Thyroidinum, Baryta carb., Berber. vulg., Bryonia, Calc. carb., Cinchona, Conium, Digitalis, Ferrum picricum, Hydrastis, Iodium, Lycopodium, Nux vom., Pareira, Pulsatilla, Sabal, Selenium, Staphysag., Thuja occ.,Trifolium pratense, Echinacea, Lappa, Solidago. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. THYROID, UNSPECIFIED; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; FERRIC PICRATE; GOLDENSEAL; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; CHONDRODENDRON TOMENTOSUM ROOT; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TRIFOLIUM PRATENSE FLOWER; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2243_56b5b5ba-f96a-f40a-5e69-c59d9649b8ec 55714-2243 HUMAN OTC DRUG Prostate Thyroidinum, Baryta carb., Berber. vulg., Bryonia, Calc. carb., Cinchona, Conium, Digitalis, Ferrum picricum, Hydrastis, Iodium, Lycopodium, Nux vom., Pareira, Pulsatilla, Sabal, Selenium, Staphysag., Thuja occ.,Trifolium pratense, Echinacea, Lappa, Solidago PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. THYROID, UNSPECIFIED; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; FERRIC PICRATE; GOLDENSEAL; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; CHONDRODENDRON TOMENTOSUM ROOT; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TRIFOLIUM PRATENSE FLOWER; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2244_63bceab0-3d1b-6a87-6ac5-7fc5fa909344 55714-2244 HUMAN OTC DRUG Nervousness - Anxiety Aconitum nap., Ambra, Anacardium orientale, Arg. nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali phos., Nux vom., Sambucus nig., Strychninum, Theridion, Valeriana, Passiflora LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ASAFETIDA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; BLACK COHOSH; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; THERIDION CURASSAVICUM; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2245_fde69292-2a85-c035-981f-45217f046f42 55714-2245 HUMAN OTC DRUG Nervousness - Anxiety Aconitum nap., Ambra, Anacardium orientale, Arg. nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali phos., Nux vom., Sambucus nig., Strychninum, Theridion, Valeriana, Passiflora PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ASAFETIDA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; BLACK COHOSH; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; THERIDION CURASSAVICUM; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2246_14fce4e1-6dbf-367f-4968-ab8eb931c117 55714-2246 HUMAN OTC DRUG Insomnia Absinthium, Anacardium orientale, Arg. nit., Arsenicum alb., Belladonna, Bryonia, Calc. carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali brom., Nux vom., Passiflora, Pulsatilla, Scutellaria lateriflora, Sepia, Thuja occ., Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. WORMWOOD; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAMPHOR (NATURAL); MATRICARIA RECUTITA; BLACK COHOSH; CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2247_ebf5c137-63c5-a23c-cf2d-cd20bac254b1 55714-2247 HUMAN OTC DRUG Insomnia Absinthium, Anacardium orientale, Arg. nit., Arsenicum alb., Belladonna, Bryonia, Calc. carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali brom., Nux vom., Passiflora, Pulsatilla, Scutellaria lateriflora, Sepia, Thuja occ., Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. WORMWOOD; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAMPHOR (NATURAL); MATRICARIA RECUTITA; BLACK COHOSH; CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2248_54cbb3c6-c697-04da-42bf-14f3996e6172 55714-2248 HUMAN OTC DRUG Throat Care Aconitum nap., Apis mel., Arum dracontium, Belladonna, Bryonia, Cajuputum, Ferrum phosphoricum, Glycyrrhiza glabra, Kali bic., Lachesis, Mentha piperita, Merc. viv., Naja, Nat. carb., Nat. sulphuricum, Nitricum ac., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Spongia, Stannum met., Sticta, Thuja occ., Ulmus fulva, Verbascum, Echinacea LIQUID ORAL 20110303 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARISAEMA DRACONTIUM ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAJUPUT OIL; FERROSOFERRIC PHOSPHATE; GLYCYRRHIZA GLABRA; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MENTHA PIPERITA; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN; LOBARIA PULMONARIA; THUJA OCCIDENTALIS LEAFY TWIG; ULMUS RUBRA BARK; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2249_4e6cf33f-eedd-b1b0-c10a-72035358ef28 55714-2249 HUMAN OTC DRUG Throat Care Aconitum nap., Apis mel., Arum dracontium, Belladonna, Bryonia, Cajuputum, Ferrum phosphoricum, Glycyrrhiza glabra, Kali bic., Lachesis, Mentha piperita, Merc. viv., Naja, Nat. carb., Nat. sulphuricum, Nitricum ac., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Spongia, Stannum met., Sticta, Thuja occ., Ulmus fulva, Verbascum, Echinacea PELLET ORAL 20110303 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARISAEMA DRACONTIUM ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAJUPUT OIL; FERROSOFERRIC PHOSPHATE; GLYCYRRHIZA GLABRA; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MENTHA PIPERITA; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN; LOBARIA PULMONARIA; THUJA OCCIDENTALIS LEAFY TWIG; ULMUS RUBRA BARK; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2252_e9867b75-dd1a-6040-ecaf-c58617cb5d03 55714-2252 HUMAN OTC DRUG Appetite - Craving Control Anacardium orientale, Antimon.crud., Arg. nit., Berber. vulg., Bryonia, Chelidonium majus, Digitalis, Graphites, Humulus,Iris versicolor, Kali carb., Lycopodium, Nat. carb.,Nat. sulphuricum, Nux vom., Pulsatilla, Rhus. toxicodendron, Scutellaria lateriflora, Sepia,Stramonium, Chamomilla, Passiflora, Valeriana. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2253_7887f3df-b389-a333-6deb-d0c6548b7493 55714-2253 HUMAN OTC DRUG Appetite - Craving Control Anacardium orientale, Antimon.crud., Arg. nit., Berber. vulg., Bryonia, Chelidonium majus, Digitalis, Graphites, Humulus,Iris versicolor, Kali carb., Lycopodium, Nat. carb.,Nat. sulphuricum, Nux vom., Pulsatilla, Rhus. toxicodendron, Scutellaria lateriflora, Sepia,Stramonium, Chamomilla, Passiflora, Valeriana. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2254_92ac3ce6-b0c7-9b83-0fba-3581bbf655b0 55714-2254 HUMAN OTC DRUG Poison Ivy Xerophyllum asphodeloides, Aconitum nap., Anacardium orientale, Apis mel., Bryonia, Cantharis, Croton, Graphites, Grindelia, Mezereum, Nux vom., Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp.,Taraxacum, Urtica ur. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. XEROPHYLLUM ASPHODELOIDES; ACONITUM NAPELLUS; SEMECARPUS ANACARDIUM JUICE; APIS MELLIFERA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CROTON TIGLIUM SEED; GRAPHITE; GRINDELIA HIRSUTULA FLOWERING TOP; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SULFUR; ECHINACEA, UNSPECIFIED; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2256_e698afca-a5b5-aa31-164f-022c2f8da43f 55714-2256 HUMAN OTC DRUG Bowel - Digestive Care Bismuthum metallicum, Antimon.crud., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; IRIS VERSICOLOR ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; RADISH; TOXICODENDRON PUBESCENS LEAF; TOBACCO LEAF; VERBASCUM THAPSUS; GINGER; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2257_4add2b49-4c76-43ce-67d6-01aab80fd287 55714-2257 HUMAN OTC DRUG Bowel - Digestive Care Bismuthum metallicum, Antimon.crud., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; IRIS VERSICOLOR ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; RADISH; TOXICODENDRON PUBESCENS LEAF; TOBACCO LEAF; VERBASCUM THAPSUS; GINGER; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_M]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2258_63d6eecb-eb2e-5487-a57d-6e51a81925ea 55714-2258 HUMAN OTC DRUG Tobacco Withdrawal Arsenicum alb., Benzoicum acidum, Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Daphne indica, Ignatia, Iris versicolor, Lycopodium, Nicotinum, Nux vom., Rhus toxicodendron, Scutellaria lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DAPHNE ODORA BARK; STRYCHNOS IGNATII SEED; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; NICOTINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; TOBACCO LEAF; ECHINACEA, UNSPECIFIED; TARAXACUM OFFICINALE; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2259_a092e2c4-a6dc-bda6-da7b-e43669d798d9 55714-2259 HUMAN OTC DRUG Tobacco Withdrawal Arsenicum alb., Benzoicum acidum, Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Daphne indica, Ignatia, Iris versicolor, Lycopodium, Nicotinum, Nux vom., Rhus toxicodendron, Scutellaria lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DAPHNE ODORA BARK; STRYCHNOS IGNATII SEED; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; NICOTINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; TOBACCO LEAF; ECHINACEA, UNSPECIFIED; TARAXACUM OFFICINALE; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2260_8b4a6e20-7eb5-fb4b-9fcd-0b92df8698c8 55714-2260 HUMAN OTC DRUG Diarrhea Pyrogenium, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Carbo veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris versicolor, Lycopodium, Podoph. pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus hipp., Juglans regia LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. RANCID BEEF; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; PODOPHYLLUM; RADISH; TOBACCO LEAF; BILBERRY; GINGER; HORSE CHESTNUT; ENGLISH WALNUT 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2261_10213dda-f751-bf0f-458c-e0181f1745cb 55714-2261 HUMAN OTC DRUG Diarrhea Pyrogenium, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Carbo veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris versicolor, Lycopodium, Podoph. pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus hipp., Juglans regia PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. RANCID BEEF; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; PODOPHYLLUM; RADISH; TOBACCO LEAF; BILBERRY; GINGER; HORSE CHESTNUT; ENGLISH WALNUT 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2262_7daea221-e01f-84f5-02ca-05c4de9c3e61 55714-2262 HUMAN OTC DRUG Stage Fright - Fear Aconitum nap., Anacardium orientale, Arg. nit., Arsenicum alb., Cypripedium, Gelsemium, Ignatia, Kali carb., Lycopodium, Nat.mur., Phosphorus, Sambucus nig., Sepia, Staphysag., Stramonium, Tarentula hispana, Theridion, Passiflora, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ARSENIC TRIOXIDE; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; LYCOSA TARANTULA; THERIDION CURASSAVICUM; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2263_0b61c5ca-b8f8-c8f8-080b-93130f8546ea 55714-2263 HUMAN OTC DRUG Stage Fright - Fear Aconitum nap., Anacardium orientale, Arg. nit., Arsenicum alb., Cypripedium, Gelsemium, Ignatia, Kali carb., Lycopodium, Nat.mur., Phosphorus, Sambucus nig., Sepia, Staphysag., Stramonium, Tarentula hispana, Theridion, Passiflora, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ARSENIC TRIOXIDE; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; LYCOSA TARANTULA; THERIDION CURASSAVICUM; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2264_196a99e0-7404-edd7-13ba-d764e4c74eee 55714-2264 HUMAN OTC DRUG Libido Agnus, Aralia quinquefolia, Baryta carb., Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Causticum, Chelidonium majus, Cinchona, Conium, Gaultheria procumbens, Graphites, Kali carb., Lycopodium, Nux vom., Onosmodium virginianum, Phosphorus, Sabal, Selenium, Sepia, Silicea, Staphysag., Hydrastis, Thuja occ LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CHASTE TREE; AMERICAN GINSENG; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; LYTTA VESICATORIA; CAUSTICUM; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; GAULTHERIA PROCUMBENS TOP; GRAPHITE; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORUS; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2265_56ccf59f-6d2b-e071-a9ad-5d4e1bc88eb8 55714-2265 HUMAN OTC DRUG Libido Agnus, Aralia quinquefolia, Baryta carb., Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Causticum, Chelidonium majus, Cinchona, Conium, Gaultheria procumbens, Graphites, Kali carb., Lycopodium, Nux vom., Onosmodium virginianum, Phosphorus, Sabal, Selenium, Sepia, Silicea, Staphysag., Hydrastis, Thuja occ PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CHASTE TREE; AMERICAN GINSENG; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; LYTTA VESICATORIA; CAUSTICUM; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; GAULTHERIA PROCUMBENS TOP; GRAPHITE; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORUS; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2266_f6fb6d21-7f9f-dccb-4fc5-249a4da4d3ec 55714-2266 HUMAN OTC DRUG Accident - Injury Rescue Aconitum nap, Arnica, Bellis, Calendula, Echinacea, Gelsemium, Hamamelis, Hypericum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis canadensis. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; GOLDENSEAL 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2267_4446bf7a-f4d8-1cf8-75f3-338cbb5b8678 55714-2267 HUMAN OTC DRUG Accident - Injury Rescue Aconitum nap, Arnica, Bellis, Calendula, Echinacea, Gelsemium, Hamamelis, Hypericum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis canadensis. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; GOLDENSEAL 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2270_b97cc613-e333-5b7f-10be-5b425f8bc84c 55714-2270 HUMAN OTC DRUG Warts - Moles - Skin Tags Antimon. crud., Bryonia, Calc.carb., Causticum, Dulcamara, Graphites, Lycopodium, Merc. sulph. rub., Nat. carb., Nitricum ac., Nux vom., Rhus toxicodendron, Sabina, Sepia, Silicea, Staphysag., Sulphur, Thuja occ., Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; SOLANUM DULCAMARA TOP; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; MERCURIC SULFIDE; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; JUNIPERUS SABINA LEAFY TWIG; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2271_093c4b61-749c-f7a8-2b52-ad59e88711c6 55714-2271 HUMAN OTC DRUG Warts - Moles - Skin Tags Antimon. crud., Bryonia, Calc.carb., Causticum, Dulcamara, Graphites, Lycopodium, Merc. sulph. rub., Nat. carb., Nitricum ac., Nux vom., Rhus toxicodendron, Sabina, Sepia, Silicea, Staphysag., Sulphur, Thuja occ., Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; SOLANUM DULCAMARA TOP; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; MERCURIC SULFIDE; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; JUNIPERUS SABINA LEAFY TWIG; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2272_90041aed-d378-6ea0-0b3c-7753ba045623 55714-2272 HUMAN OTC DRUG Muscle Ease Aconitum nap., Antimon. tart.,Arg. nit., Arnica, Bryonia, Chamomilla,Chelidonium majus, Cimicifuga, Eupatorium perf.,Hypericum, Nux vom., Rhus toxicodendron, Ruta,Sarcolacticum ac., Stramonium, Strychninum,Chamomilla, Phytolacca, Ruta, Symphytum. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; SILVER NITRATE; ARNICA MONTANA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; BLACK COHOSH; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYPERICUM PERFORATUM; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DATURA STRAMONIUM; STRYCHNINE; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2273_64f7bb72-b361-483a-0ebf-c2a336ee2742 55714-2273 HUMAN OTC DRUG Muscle Ease Aconitum nap., Antimon. tart.,Arg. nit., Arnica, Bryonia, Chamomilla,Chelidonium majus, Cimicifuga, Eupatorium perf.,Hypericum, Nux vom., Rhus toxicodendron, Ruta,Sarcolacticum ac., Stramonium, Strychninum,Chamomilla, Phytolacca, Ruta, Symphytum. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; SILVER NITRATE; ARNICA MONTANA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; BLACK COHOSH; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYPERICUM PERFORATUM; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DATURA STRAMONIUM; STRYCHNINE; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2274_254ae2c4-5707-f56d-5175-12cc8e93442a 55714-2274 HUMAN OTC DRUG Bug Bites - Itch Stopper Pyrogenium, Apis mel., Aranea diadema, Arnica, Arsenicum alb., Azadirachta indica, Bryonia, Caladium seguinum, Calendula, Formica, Grindelia, Hypericum, Lachesis, Latrodectus mactans, Ledum, Mezereum, Nux vom., Pulex irritans, Rhus toxicodendron, Tarentula cubensis, Tarentula hispana, Theridion, Thuja occ., Vespa crabro, Echinacea, Hamamelis, Solidago LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. RANCID BEEF; APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; CALENDULA OFFICINALIS FLOWERING TOP; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULEX IRRITANS; TOXICODENDRON PUBESCENS LEAF; CITHARACANTHUS SPINICRUS; LYCOSA TARANTULA; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; VESPA CRABRO; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; SOLIDAGO VIRGAUREA FLOWERING TOP 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2275_da159cbd-50d9-a529-fd44-f595bd34f9d5 55714-2275 HUMAN OTC DRUG Bug Bites - Itch Stopper Pyrogenium, Apis mel., Aranea diadema, Arnica, Arsenicum alb., Azadirachta indica, Bryonia, Caladium seguinum, Calendula, Formica, Grindelia, Hypericum, Lachesis, Latrodectus mactans, Ledum, Mezereum, Nux vom., Pulex irritans, Rhus toxicodendron, Tarentula cubensis, Tarentula hispana, Theridion, Thuja occ., Vespa crabro, Echinacea, Hamamelis, Solidago PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. RANCID BEEF; APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; CALENDULA OFFICINALIS FLOWERING TOP; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULEX IRRITANS; TOXICODENDRON PUBESCENS LEAF; CITHARACANTHUS SPINICRUS; LYCOSA TARANTULA; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; VESPA CRABRO; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; SOLIDAGO VIRGAUREA FLOWERING TOP 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2276_8d6c7169-b7d4-0d60-6558-97efb8c7d680 55714-2276 HUMAN OTC DRUG Cold Sores Arsenicum alb., Bryonia, Cantharis, Chelidonium majus, Cistus canadensis, Conium, Croton, Dulcamara, Graphites, Kali bic., Lycopodium, Mezereum, Nux vom., Petroleum, Pulsatilla, Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur, Thuja occ., Echinacea, Hypericum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; HELIANTHEMUM CANADENSE; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SEPIA OFFICINALIS JUICE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2277_cc0a55eb-6c5d-997d-0ddf-58cdb956fe39 55714-2277 HUMAN OTC DRUG Cold Sores Arsenicum alb., Bryonia, Cantharis, Chelidonium majus, Cistus canadensis, Conium, Croton, Dulcamara, Graphites, Kali bic., Lycopodium, Mezereum, Nux vom., Petroleum, Pulsatilla, Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur, Thuja occ., Echinacea, Hypericum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; HELIANTHEMUM CANADENSE; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SEPIA OFFICINALIS JUICE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2278_137d0005-78bb-8b9a-a2d6-f67b0f073196 55714-2278 HUMAN OTC DRUG Caffeine Withdrawal Aconitum nap., Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Coffea cruda, Conium, Gelsemium, Ignatia, Iris versicolor, Mezereum, Nux vom., Passiflora, Pulsatilla, Rhus toxicodendron, Scutellaria lateriflora, Staphysag., Chamomilla, Taraxacum, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; IRIS VERSICOLOR ROOT; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; DELPHINIUM STAPHISAGRIA SEED; MATRICARIA RECUTITA; TARAXACUM OFFICINALE; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2279_ba2bda92-9158-d59b-1160-0b222c9f6527 55714-2279 HUMAN OTC DRUG Caffeine Withdrawal Aconitum nap., Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Coffea cruda, Conium, Gelsemium, Ignatia, Iris versicolor, Mezereum, Nux vom., Passiflora, Pulsatilla, Rhus toxicodendron, Scutellaria lateriflora, Staphysag., Chamomilla, Taraxacum, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; IRIS VERSICOLOR ROOT; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; DELPHINIUM STAPHISAGRIA SEED; MATRICARIA RECUTITA; TARAXACUM OFFICINALE; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2280_db6355a8-478f-3bd5-22c7-73b88eace0c7 55714-2280 HUMAN OTC DRUG Eye Care Aconitum nap., Allium cepa, Arsenicum alb., Bryonia, Calendula, Chelidonium majus, Cineraria, Euphrasia, Graphites, Lycopodium, Merc. corros., Nux vom., Phosphorus, Phytolacca, Picricum ac., Pulsatilla, Rhus toxicodendron, Sulphur, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ONION; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; JACOBAEA MARITIMA; EUPHRASIA STRICTA; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; TRINITROPHENOL; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SULFUR; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2281_0cdaae06-82bf-8134-8429-43d7924346c5 55714-2281 HUMAN OTC DRUG Eye Care Aconitum nap., Allium cepa, Arsenicum alb., Bryonia, Calendula, Chelidonium majus, Cineraria, Euphrasia, Graphites, Lycopodium, Merc. corros., Nux vom., Phosphorus, Phytolacca, Picricum ac., Pulsatilla, Rhus toxicodendron, Sulphur, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ONION; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; JACOBAEA MARITIMA; EUPHRASIA STRICTA; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; TRINITROPHENOL; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SULFUR; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2282_26bb8fdc-df6f-d2f7-0482-c007c3558335 55714-2282 HUMAN OTC DRUG Teeth - Gums Aconitum nap., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium majus, Crotalus horridus, Gelsemium, Hepar sulph. calc., Kreosotum, Merc. viv., Myrrha, Nux vom., Phosphorus, Phytolacca, Plantago, Rhus toxicodendron, Silicea, Staphysag., Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; WOOD CREOSOTE; MERCURY; MYRRH; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2283_09793a85-57fc-21ef-624c-5755a13d8bb6 55714-2283 HUMAN OTC DRUG Teeth - Gums Aconitum nap., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium majus, Crotalus horridus, Gelsemium, Hepar sulph. calc., Kreosotum, Merc. viv., Myrrha, Nux vom., Phosphorus, Phytolacca, Plantago, Rhus toxicodendron, Silicea, Staphysag., Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; WOOD CREOSOTE; MERCURY; MYRRH; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2284_09574572-27ff-dcdf-b5b3-3fc8baa481ec 55714-2284 HUMAN OTC DRUG Hives - Rashes Antimon. crud., Apis mel., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Histaminum hydrochloricum, Lycopodium, Mezereum, Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULEX IRRITANS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SULFUR; ECHINACEA, UNSPECIFIED; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2285_b8fc2c22-2a8a-2815-9bbd-cdb4bed61833 55714-2285 HUMAN OTC DRUG Hives - Rashes Antimon. crud., Apis mel., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Histaminum hydrochloricum, Lycopodium, Mezereum, Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULEX IRRITANS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SULFUR; ECHINACEA, UNSPECIFIED; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2286_f1c3d3a2-259d-4e89-0b9b-e159bacf90e2 55714-2286 HUMAN OTC DRUG Incontinence Aloe, Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Bryonia, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Ignatia, Kali phos., Lycopodium, Nat. mur., Nitricum ac., Plantago, Pulsatilla, Rhus aromatica , Sabal, Secale, Sepia, Staphysag.,Stramonium, Thyroidinum, Verbascum, Echinacea, Hydrastis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CAUSTICUM; EQUISETUM HYEMALE; IRON; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; NITRIC ACID; PLANTAGO MAJOR; PULSATILLA VULGARIS; RHUS AROMATICA ROOT BARK; SAW PALMETTO; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THYROID, UNSPECIFIED; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2287_8f52db34-78ea-1c28-0fc9-f942ce974760 55714-2287 HUMAN OTC DRUG Incontinence Aloe, Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Bryonia, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Ignatia, Kali phos., Lycopodium, Nat. mur., Nitricum ac., Plantago, Pulsatilla, Rhus aromatica , Sabal, Secale, Sepia, Staphysag.,Stramonium, Thyroidinum, Verbascum, Echinacea, Hydrastis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CAUSTICUM; EQUISETUM HYEMALE; IRON; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; NITRIC ACID; PLANTAGO MAJOR; PULSATILLA VULGARIS; RHUS AROMATICA ROOT BARK; SAW PALMETTO; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THYROID, UNSPECIFIED; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2288_507e4e0b-2547-9597-999d-98db06b82d23 55714-2288 HUMAN OTC DRUG Motion Sickness Absinthium, Aconitum nap., Antimon. tart., Belladonna, Bryonia, Carbolicum acidum, Colchicum, Conium, Ferrum metallicum, Gelsemium, Glonoinum, Hyoscyamus, Ipecac., Iris versicolor, Lycopodium, Nux vom., Petroleum, Phosphorus, Sepia, Symphoricarpus racemosus, Tabacum, Theridion, Zingiber, Echinacea, Hypericum, Passiflora, Valeriana LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. WORMWOOD; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; PHENOL; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; HYOSCYAMUS NIGER; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SYMPHORICARPOS ALBUS FRUIT; TOBACCO LEAF; THERIDION CURASSAVICUM; GINGER; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2289_ac0e970b-03d4-dd60-f39a-0b9a19de3a18 55714-2289 HUMAN OTC DRUG Motion Sickness Absinthium, Aconitum nap., Antimon. tart., Belladonna, Bryonia, Carbolicum acidum, Colchicum, Conium, Ferrum metallicum, Gelsemium, Glonoinum, Hyoscyamus, Ipecac., Iris versicolor, Lycopodium, Nux vom., Petroleum, Phosphorus, Sepia, Symphoricarpus racemosus, Tabacum, Theridion, Zingiber, Echinacea, Hypericum, Passiflora, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. WORMWOOD; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; PHENOL; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; HYOSCYAMUS NIGER; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SYMPHORICARPOS ALBUS FRUIT; TOBACCO LEAF; THERIDION CURASSAVICUM; GINGER; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2290_f5d7bb39-9a7b-a131-79f9-6f57d3447a65 55714-2290 HUMAN OTC DRUG Feminine Comfort Agaricus musc., Arsenicum alb., Aur. met., Berber. aqui., Caladium seguinum, Candida albicans, Cantharis, Conium, Graphites, Helonias dioica, Hydrastis, Kali carb., Kreosotum, Lycopodium, Merc. viv., Murex purpurea, Nat. mur., Nitricum ac., Pulsatilla, Rhus toxicodendron, Sepia, Sulphur, Tarentula hispana, Thuja occ., Zinc. met., Apis mel., Hamamelis LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; GOLD; MAHONIA AQUIFOLIUM ROOT BARK; DIEFFENBACHIA SEGUINE; CANDIDA ALBICANS; LYTTA VESICATORIA; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; POTASSIUM CARBONATE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; MERCURY; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; SODIUM CHLORIDE; NITRIC ACID; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; LYCOSA TARANTULA; THUJA OCCIDENTALIS LEAFY TWIG; ZINC; APIS MELLIFERA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2291_5f855a16-a2cd-e5ff-4c19-4edfa96ac5cd 55714-2291 HUMAN OTC DRUG Feminine Comfort Agaricus musc., Arsenicum alb., Aur. met., Berber. aqui., Caladium seguinum, Candida albicans, Cantharis, Conium, Graphites, Helonias dioica, Hydrastis, Kali carb., Kreosotum, Lycopodium, Merc. viv., Murex purpurea, Nat. mur., Nitricum ac., Pulsatilla, Rhus toxicodendron, Sepia, Sulphur, Tarentula hispana, Thuja occ., Zinc. met., Apis mel., Hamamelis PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; GOLD; MAHONIA AQUIFOLIUM ROOT BARK; DIEFFENBACHIA SEGUINE; CANDIDA ALBICANS; LYTTA VESICATORIA; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; POTASSIUM CARBONATE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; MERCURY; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; SODIUM CHLORIDE; NITRIC ACID; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; LYCOSA TARANTULA; THUJA OCCIDENTALIS LEAFY TWIG; ZINC; APIS MELLIFERA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2292_1d06d506-7345-4abf-c075-0244a73742b2 55714-2292 HUMAN OTC DRUG Hair Scalp Apis mel., Arsenicum alb., Calc. carb., Dulcamara, Graphites, Hepar sulph. calc., Hydrastis, Hydrofluoricum acidum, Kali carb., Lycopodium, Mezereum, Oleander, Petroleum, Phosphoricum ac., Phosphorus, Rhus toxicodendron, Selenium, Sepia, Silicea, Sulphur, Hydrastis,Thuja occ. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SOLANUM DULCAMARA TOP; GRAPHITE; CALCIUM SULFIDE; GOLDENSEAL; HYDROFLUORIC ACID; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; NERIUM OLEANDER LEAF; KEROSENE; PHOSPHORIC ACID; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2293_7d9d64e3-6f89-468b-99d8-96a4d08905b5 55714-2293 HUMAN OTC DRUG Hair Scalp Apis mel., Arsenicum alb., Calc. carb., Dulcamara, Graphites, Hepar sulph. calc., Hydrastis, Hydrofluoricum acidum, Kali carb., Lycopodium, Mezereum, Oleander, Petroleum, Phosphoricum ac., Phosphorus, Rhus toxicodendron, Selenium, Sepia, Silicea, Sulphur, Thuja occ. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SOLANUM DULCAMARA TOP; GRAPHITE; CALCIUM SULFIDE; GOLDENSEAL; HYDROFLUORIC ACID; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; NERIUM OLEANDER LEAF; KEROSENE; PHOSPHORIC ACID; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2294_60d44f14-0b8c-71cd-b2fc-72f33ef2dfd8 55714-2294 HUMAN OTC DRUG Leg Cramps - Swelling Elaps corallinus, Arg. nit., Bryonia, Calc. carb., Colocynthis, Convallaria, Crotalus horridus, Cuprum met., Digitalis, Gelsemium, Hypericum, Kali carb., Lachesis, Lathyrus sativus, Lilium, Mag. phos., Nux vom., Rhus toxicodendron, Silicea, Stramonium, Veratrum viride, Echinacea LIQUID ORAL 20120301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; SILVER NITRATE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CITRULLUS COLOCYNTHIS FRUIT PULP; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; COPPER; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LATHYRUS SATIVAS SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; DATURA STRAMONIUM; VERATRUM VIRIDE ROOT; ECHINACEA, UNSPECIFIED 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2295_845c979e-a9fc-9f1f-20d7-70cbed00044f 55714-2295 HUMAN OTC DRUG Leg Cramps - Swelling Elaps corallinus, Arg. nit., Bryonia, Calc. carb., Colocynthis, Convallaria, Crotalus horridus, Cuprum met., Digitalis, Gelsemium, Hypericum, Kali carb., Lachesis, Lathyrus sativus, Lilium, Mag. phos., Nux vom., Rhus toxicodendron, Silicea, Stramonium, Veratrum viride, Echinacea PELLET ORAL 20120301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; SILVER NITRATE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CITRULLUS COLOCYNTHIS FRUIT PULP; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; COPPER; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LATHYRUS SATIVAS SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; DATURA STRAMONIUM; VERATRUM VIRIDE ROOT; ECHINACEA, UNSPECIFIED 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2296_745542e3-7a69-de04-cd8d-5f45496c57f8 55714-2296 HUMAN OTC DRUG Sciatica - Nerve Care Aconitum nap., Ammonium benzoicum, Arsenicum alb., Benzoicum acidum, Bryonia, Causticum, Cinchona, Colchicum, Gnaphalium polycephalum, Iris versicolor, Kali iod., Ledum, Lithium carb., Nux vom., Phytolacca, Rhus toxicodendron, Ruta, Sambucus nig., Strychninum, Hypericum, Urtica ur. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMMONIUM BENZOATE; ARSENIC TRIOXIDE; BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; PSEUDOGNAPHALIUM OBTUSIFOLIUM; IRIS VERSICOLOR ROOT; POTASSIUM IODIDE; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; HYPERICUM PERFORATUM; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2297_a73d4136-fab5-4280-8141-4eb9c02a347d 55714-2297 HUMAN OTC DRUG Sciatica - Nerve Care Aconitum nap., Ammonium benzoicum, Arsenicum alb., Benzoicum acidum, Bryonia, Causticum, Cinchona, Colchicum, Gnaphalium polycephalum, Iris versicolor, Kali iod., Ledum, Lithium carb., Nux vom., Phytolacca, Rhus toxicoderon, Ruta, Sambucus nig., Strychninum, Hypericum, Urtica ur PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMMONIUM BENZOATE; ARSENIC TRIOXIDE; BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; PSEUDOGNAPHALIUM OBTUSIFOLIUM; IRIS VERSICOLOR ROOT; POTASSIUM IODIDE; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; HYPERICUM PERFORATUM; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2298_755677a5-0b26-9fe5-8de4-27b6cad38ba3 55714-2298 HUMAN OTC DRUG Fatigue Fighter Aconitum nap., Adrenalinum, Aralia quinquefolia, Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Cinchona, Iodium, Kali carb., Kali iod., Lachesis, Lycopodium, Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; EPINEPHRINE; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; GINKGO; PHYTOLACCA AMERICANA ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2299_7c57ff22-b388-15a2-8010-de1da5b41c8d 55714-2299 HUMAN OTC DRUG Fatigue Fighter Aconitum nap., Adrenalinum, Aralia quinquefolia, Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Cinchona, Iodium, Kali carb., Kali iod., Lachesis, Lycopodium, Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; EPINEPHRINE; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; GINKGO; PHYTOLACCA AMERICANA ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2300_41d6bd3a-64f7-2c4f-db39-e8287a49badd 55714-2300 HUMAN OTC DRUG Inflammation Anthracinum, Pyrogenium, Aconitum nap., Aloe, Apis mel., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chelidonium majus, Crotalus horridus, Ferrum phosphoricum, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Veratrum viride, Verbascum, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; RANCID BEEF; ACONITUM NAPELLUS; ALOE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; FERROSOFERRIC PHOSPHATE; GAULTHERIA PROCUMBENS TOP; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2301_209d2d0b-d89f-d407-1569-46f6a88f5ae3 55714-2301 HUMAN OTC DRUG Inflammation Anthracinum, Pyrogenium, Aconitum nap., Aloe, Apis mel., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chelidonium majus, Crotalus horridus, Ferrum phosphoricum, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Veratrum viride, Verbascum, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; RANCID BEEF; ACONITUM NAPELLUS; ALOE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; FERROSOFERRIC PHOSPHATE; GAULTHERIA PROCUMBENS TOP; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2302_dd82deb6-055c-7741-6ea2-97892f2c53cd 55714-2302 HUMAN OTC DRUG Cold Hands - Feet Histaminum hydrochloricum,Thyroidinum, Aconitum nap., Arsenicum alb., Bryonia, Cactus, Calc. fluor., Ceanothus, Cinchona, Convallaria, Digitalis, Gelsemium, Glonoinum, Hydrocoyle, Kali carb., Lachesis, Naja, nat carb., Nat mur., Nux vom., Phosphorus, Pullsatilla, Rhus toxicodendron, Strophanthus hispidus, Sulphur, Echinacea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. HISTAMINE DIHYDROCHLORIDE; THYROID, UNSPECIFIED; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; SELENICEREUS GRANDIFLORUS STEM; CALCIUM FLUORIDE; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; CENTELLA ASIATICA; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; STROPHANTHUS HISPIDUS SEED; SULFUR; ECHINACEA, UNSPECIFIED 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2303_c53cdda7-96d8-ee85-68ac-86d0756eb54e 55714-2303 HUMAN OTC DRUG Cold Hands - Feet Histaminum hydrochloricum,Thyroidinum, Aconitum nap., Arsenicum alb., Bryonia, Cactus, Calc. fluor., Ceanothus, Cinchona, Convallaria, Digitalis, Gelsemium, Glonoinum, Hydrocoyle, Kali carb., Lachesis, Naja, nat carb., Nat mur., Nux vom., Phosphorus, Pullsatilla, Rhus toxicodendron, Strophanthus hispidus, Sulphur, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. HISTAMINE DIHYDROCHLORIDE; THYROID, UNSPECIFIED; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; SELENICEREUS GRANDIFLORUS STEM; CALCIUM FLUORIDE; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; CONVALLARIA MAJALIS; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; CENTELLA ASIATICA; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; STROPHANTHUS HISPIDUS SEED; SULFUR; ECHINACEA, UNSPECIFIED 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2304_9bce009d-18fa-9bfd-e1b8-ccd9fd0fa3a7 55714-2304 HUMAN OTC DRUG Parasites Abrotanum, Aesculus hipp., Allium sativum, Arsenicum alb., Artemisia, Baptisia, Cina, Cuprum met., Filix mas, Granatum, Ipecac, Lachesis, Lycopodium, Merc. viv, Naphthalinum, Nat. mur., Nux vom., Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth., Terebinthina, Teucrium marum, Thymolum, Zingiber, Juglans regia LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARTEMISIA ABROTANUM FLOWERING TOP; HORSE CHESTNUT; GARLIC; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; BAPTISIA TINCTORIA; ARTEMISIA MARITIMA FLOWER; COPPER; DRYOPTERIS FILIX-MAS ROOT; PUNICA GRANATUM ROOT BARK; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; NAPHTHALENE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; KRAMERIA LAPPACEA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; SANTONIN; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TURPENTINE OIL; TEUCRIUM MARUM; THYMOL; GINGER; ENGLISH WALNUT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2305_a03057fa-45b5-9c4e-a357-aba2d3d5b893 55714-2305 HUMAN OTC DRUG Parasites Abrotanum, Aesculus hipp., Allium sativum, Arsenicum alb., Artemisia, Baptisia, Cina, Cuprum met., Filix mas, Granatum, Ipecac, Lachesis, Lycopodium, Merc. viv, Naphthalinum, Nat. mur., Nux vom., Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth., Terebinthina, Teucrium marum, Thymolum, Zingiber, Juglans regia PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARTEMISIA ABROTANUM FLOWERING TOP; HORSE CHESTNUT; GARLIC; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; BAPTISIA TINCTORIA; ARTEMISIA MARITIMA FLOWER; COPPER; DRYOPTERIS FILIX-MAS ROOT; PUNICA GRANATUM ROOT BARK; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; NAPHTHALENE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; KRAMERIA LAPPACEA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; SANTONIN; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TURPENTINE OIL; TEUCRIUM MARUM; THYMOL; GINGER; ENGLISH WALNUT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2306_8aa7f69b-a7be-de1a-d092-2a9dd6c184cf 55714-2306 HUMAN OTC DRUG Snore Soothe Histaminum hydrochloricum Laccaninum, Arsenicum alb., Belladonna Bryonia,Camphora, Cistus canadensis, Drosera, Hepar sulph.calc., Hydrastis, Ignatia, Iodium, Kali bic.,Kali iod., Nux vom., Phosphorus, Pulsatilla,Sabadilla, Silicea, Sticta, Sulphur, Teucriummarum, Verbascum, Echinacea. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. HISTAMINE DIHYDROCHLORIDE; CANIS LUPUS FAMILIARIS MILK; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); HELIANTHEMUM CANADENSE; DROSERA ROTUNDIFOLIA FLOWERING TOP; CALCIUM SULFIDE; GOLDENSEAL; STRYCHNOS IGNATII SEED; IODINE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; LOBARIA PULMONARIA; SULFUR; TEUCRIUM MARUM; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2307_62f4d3a0-8a5f-eb2c-0fe3-f9356e2a5ddb 55714-2307 HUMAN OTC DRUG Snore Soothe Histaminum hydrochloricum, Lac caninum, Arsenicum alb., Belladonna, Bryonia, Camphora, Cistus canadensis, Drosera, Hepar sulph.calc., Hydrastis, Ignatia, Iodium, Kali bic.,Kali iod., Nux vom., Phosphorus, Pulsatilla, Sabadilla, Silicea, Sticta, Sulphur, Teucrium marum, Verbascum, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. HISTAMINE DIHYDROCHLORIDE; CANIS LUPUS FAMILIARIS MILK; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); HELIANTHEMUM CANADENSE; DROSERA ROTUNDIFOLIA FLOWERING TOP; CALCIUM SULFIDE; GOLDENSEAL; STRYCHNOS IGNATII SEED; IODINE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; LOBARIA PULMONARIA; SULFUR; TEUCRIUM MARUM; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2308_a4aa709d-4744-9f4e-3de9-71c16968f304 55714-2308 HUMAN OTC DRUG Pollen Weeds Xerophyllum asphodeloides, Adrenalinum, Alfalfa, Aletris farinosa, Artemisia vulgaris, Bellis perennis, Dysphania ambrosioides, Lycopus virginicus, Phytolacca american root, Populus tremuloides, Ptelea trifoliata, Sambusus nigra, Trillium erectum root, Elymus repens root, Urtica urens, Wyethia helenioides, Yucca filamentosa, Avena sativa pollen, Cynosurus cristatus pollen. Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. XEROPHYLLUM ASPHODELOIDES; EPINEPHRINE; ALFALFA; ALETRIS FARINOSA ROOT; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; DYSPHANIA AMBROSIOIDES; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PTELEA TRIFOLIATA BARK; SAMBUCUS NIGRA FLOWERING TOP; TRILLIUM ERECTUM ROOT; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; YUCCA FILAMENTOSA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POPULUS BALSAMIFERA LEAF BUD; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; USTILAGO MAYDIS; ONION; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; DIOSCOREA VILLOSA TUBER; GINKGO; GOLDENSEAL; TARAXACUM OFFICINALE; ANTHOXANTHUM ODORATUM POLLEN 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2309_0fadf26b-45bf-620b-cd13-1f31587c6487 55714-2309 HUMAN OTC DRUG Pollen Weeds Xerophyllum asphodeloides, Adrenalinum, Alfalfa, Aletris farinosa, Artemisia vulgaris, Bellis perennis, Dysphania ambrosioides, Lycopus virginicus, Phytolacca american root, Populus tremuloides, Ptelea trifoliata, Sambusus nigra, Trillium erectum root, Elymus repens root, Urtica urens, Wyethia helenioides, Yucca filamentosa, Avena sativa pollen, Cynosurus cristatus pollen. Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. XEROPHYLLUM ASPHODELOIDES; EPINEPHRINE; ALFALFA; ALETRIS FARINOSA ROOT; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; DYSPHANIA AMBROSIOIDES; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PTELEA TRIFOLIATA BARK; SAMBUCUS NIGRA FLOWERING TOP; TRILLIUM ERECTUM ROOT; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; YUCCA FILAMENTOSA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POPULUS BALSAMIFERA LEAF BUD; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; USTILAGO MAYDIS; ONION; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; DIOSCOREA VILLOSA TUBER; GINKGO; GOLDENSEAL; TARAXACUM OFFICINALE; ANTHOXANTHUM ODORATUM POLLEN 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2310_09bf43dc-58ab-2436-3e51-da74cf5b2179 55714-2310 HUMAN OTC DRUG Dust - Mold - Dander Felis catus skin, Canis lupus familiaris skin, Ortcyolagus cuniculus skin, Equus caballus skin, Serinus canaria feather, Gallus gallus feather, Anas platyrhynchos feather, Anser anser feather, Melopsittacus undulatus feather, Phasianus colchicus feather, Meleagris gallopavo feather, Felis catus hair, Human dander, Canis lupus familiaris hair, Equus caballus hair, Oryctolagus cuniculus hair, Human hair, Human skin, Sheep wool, Bos taurus hair, Capra hircus hair, Cavia porcellus hair LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. FELIS CATUS SKIN; CANIS LUPUS FAMILIARIS SKIN; ORYCTOLAGUS CUNICULUS SKIN; EQUUS CABALLUS SKIN; SERINUS CANARIA FEATHER; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; MELOPSITTACUS UNDULATUS FEATHER; PHASIANUS COLCHICUS FEATHER; MELEAGRIS GALLOPAVO FEATHER; FELIS CATUS HAIR; HUMAN DANDER; CANIS LUPUS FAMILIARIS HAIR; EQUUS CABALLUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; HUMAN HAIR; HUMAN SKIN; SHEEP WOOL; BOS TAURUS HAIR; CAPRA HIRCUS HAIR; CAVIA PORCELLUS HAIR; MESOCRICETUS AURATUS HAIR; WHEAT GLUTEN; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM HERBARUM; HOUSE DUST; CANDIDA ALBICANS; HISTAMINE DIHYDROCHLORIDE; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BLATTA ORIENTALIS; BROMINE; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2311_4877a63a-1508-6adb-8d42-f30033600d58 55714-2311 HUMAN OTC DRUG Dust - Mold - Dander Felis catus skin, Canis lupus familiaris skin, Ortcyolagus cuniculus skin, Equus caballus skin, Serinus canaria feather, Gallus gallus feather, Anas platyrhynchos feather, Anser anser feather, Melopsittacus undulatus feather, Phasianus colchicus feather, Meleagris gallopavo feather, Felis catus hair, Human dander, Canis lupus familiaris hair, Equus caballus hair, Oryctolagus cuniculus hair, Human hair, Human skin, Sheep wool, Bos taurus hair, Capra hircus hair, Cavia porcellus hair PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. FELIS CATUS SKIN; CANIS LUPUS FAMILIARIS SKIN; ORYCTOLAGUS CUNICULUS SKIN; EQUUS CABALLUS SKIN; SERINUS CANARIA FEATHER; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; MELOPSITTACUS UNDULATUS FEATHER; PHASIANUS COLCHICUS FEATHER; MELEAGRIS GALLOPAVO FEATHER; FELIS CATUS HAIR; HUMAN DANDER; CANIS LUPUS FAMILIARIS HAIR; EQUUS CABALLUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; HUMAN HAIR; HUMAN SKIN; SHEEP WOOL; BOS TAURUS HAIR; CAPRA HIRCUS HAIR; CAVIA PORCELLUS HAIR; MESOCRICETUS AURATUS HAIR; WHEAT GLUTEN; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM HERBARUM; HOUSE DUST; CANDIDA ALBICANS; HISTAMINE DIHYDROCHLORIDE; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BLATTA ORIENTALIS; BROMINE; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2312_eb378ec1-86b5-b39f-14c6-608d8dbbe2a5 55714-2312 HUMAN OTC DRUG Dairy - Grain - Nightshades Cow milk, Skim milk, Cow milk fat, Casein lactococcus lactis cultured aged, Casein lactococcus lactis cultured penicilium roqueforti cultured aged, Casein lctococcus lactis cultured penicillium camemberti cultured aged, Barley, Corn, Wheat gluten, Oat, White rice, Rye, Wheat, Lycopersicum esculentum, Sac. lac., Solanum tuberosum,Torula cerevisiae, Ustilago maidis, Antimon. crud., Arg.nit., Arsenicum alb., Baptisia, Bryonia, Carduus benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. COW MILK; SKIM MILK; COW MILK FAT; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; BARLEY; CORN; WHEAT GLUTEN; OAT; WHITE RICE; RYE; WHEAT; ATROPA BELLADONNA; CAPSICUM; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; SOLANUM NIGRUM WHOLE; DATURA STRAMONIUM; TOBACCO LEAF; SOLANUM LYCOPERSICUM; LACTOSE; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; ELYMUS REPENS ROOT; VERBASCUM THAPSUS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2313_7fe9b9c7-63f2-46be-8a2a-97780bec0ad6 55714-2313 HUMAN OTC DRUG Dairy - Grain - Nightshades Cow milk, Skim milk, Cow milk fat, Casein lactococcus lactis cultured aged, Casein lactococcus lactis cultured penicilium roqueforti cultured aged, Casein lctococcus lactis cultured penicillium camemberti cultured aged, Barley, Corn, Wheat gluten, Oat, White rice, Rye, Wheat, Lycopersicum esculentum, Sac. lac., Solanum tuberosum,Torula cerevisiae, Ustilago maidis, Antimon. crud., Arg.nit., Arsenicum alb., Baptisia, Bryonia, Carduus benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. COW MILK; SKIM MILK; COW MILK FAT; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; BARLEY; CORN; WHEAT GLUTEN; OAT; WHITE RICE; RYE; WHEAT; ATROPA BELLADONNA; CAPSICUM; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; SOLANUM NIGRUM WHOLE; DATURA STRAMONIUM; TOBACCO LEAF; SOLANUM LYCOPERSICUM; LACTOSE; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; ELYMUS REPENS ROOT; VERBASCUM THAPSUS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2314_744a10d8-a21f-7cf4-3d71-dec58594bea8 55714-2314 HUMAN OTC DRUG Food Allergy - Additive E102 Tartrazine, E104 Quinoline yellow, E110 Sunset/Orange yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal red A, E127 Erythrosine, D128 Red 2G, E 132 Indigotine, E141 Copper/Chlorophyll Complex, E142 Green S, E211 Sodium benzoate, E212 Potassium benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium metabisulphate, E231 Orthophenylphenol, E250 Sodium nitrate, E300 Ascorbic acid, E399 Sodium mono/bi/triphosphate, E951 Aspartame, Monosodium glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EGG; FD&C YELLOW NO. 5; D&C YELLOW NO. 10; FD&C YELLOW NO. 6; CARMOISINE; AMARANTH; PONCEAU 4R; FD&C RED NO. 3; ACID RED 1; FD&C BLUE NO. 2; SODIUM COPPER CHLOROPHYLLIN; ACID GREEN 50; SODIUM BENZOATE; POTASSIUM BENZOATE; PROPYLPARABEN; SODIUM DITHIONATE; 2-PHENYLPHENOL; SODIUM NITRITE; ASCORBIC ACID; SODIUM TRIPOLYPHOSPHATE; ASPARTAME; MONOSODIUM GLUTAMATE; BEEF; PORK; LAMB; CHICKEN; TURKEY; QUAHOG, UNSPECIFIED; CRAB LEG, UNSPECIFIED; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; SCALLOP, UNSPECIFIED; AMANITA MUSCARIA FRUITING BODY; ONION; GARLIC; ANACARDIUM OCCIDENTALE FRUIT; LYCOPERDON UTRIFORME FRUITING BODY; CAFFEINE; CAPSICUM; CINNAMON; CYNARA SCOLYMUS LEAF; ALPINE STRAWBERRY; ABRUS PRECATORIUS SEED; GLYCYRRHIZA GLABRA; MENTHA PIPERITA; NUTMEG; LACTOSE; SUCROSE; BLACK MUSTARD SEED; SOLANUM NIGRUM WHOLE; ALLYLTHIOUREA; USTILAGO MAYDIS; GINGER; BRAZIL NUT; HAZELNUT, UNSPECIFIED; PEANUT; TROUT, UNSPECIFIED; COD, UNSPECIFIED; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; SOLANUM LYCOPERSICUM; SACCHARIN; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; URTICA URENS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2315_52e7721b-976f-1cf3-b960-6e76224890c0 55714-2315 HUMAN OTC DRUG Food Allergy - Additive E102 Tartrazine, E104 Quinoline yellow, E110 Sunset/Orange yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal red A, E127 Erythrosine, D128 Red 2G, E 132 Indigotine, E141 Copper/Chlorophyll Complex, E142 Green S, E211 Sodium benzoate, E212 Potassium benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium metabisulphate, E231 Orthophenylphenol, E250 Sodium nitrate, E300 Ascorbic acid, E399 Sodium mono/bi/triphosphate, E951 Aspartame, Monosodium glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EGG; FD&C YELLOW NO. 5; D&C YELLOW NO. 10; FD&C YELLOW NO. 6; CARMOISINE; AMARANTH; PONCEAU 4R; FD&C RED NO. 3; ACID RED 1; FD&C BLUE NO. 2; SODIUM COPPER CHLOROPHYLLIN; ACID GREEN 50; SODIUM BENZOATE; POTASSIUM BENZOATE; PROPYLPARABEN; SODIUM DITHIONATE; 2-PHENYLPHENOL; SODIUM NITRITE; ASCORBIC ACID; SODIUM TRIPOLYPHOSPHATE; ASPARTAME; MONOSODIUM GLUTAMATE; BEEF; PORK; LAMB; CHICKEN; TURKEY; QUAHOG, UNSPECIFIED; CRAB LEG, UNSPECIFIED; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; SCALLOP, UNSPECIFIED; AMANITA MUSCARIA FRUITING BODY; ONION; GARLIC; ANACARDIUM OCCIDENTALE FRUIT; LYCOPERDON UTRIFORME FRUITING BODY; CAFFEINE; CAPSICUM; CINNAMON; CYNARA SCOLYMUS LEAF; ALPINE STRAWBERRY; ABRUS PRECATORIUS SEED; GLYCYRRHIZA GLABRA; MENTHA PIPERITA; NUTMEG; LACTOSE; BLACK MUSTARD SEED; SOLANUM NIGRUM WHOLE; ALLYLTHIOUREA; USTILAGO MAYDIS; GINGER; BRAZIL NUT; HAZELNUT, UNSPECIFIED; PEANUT; TROUT, UNSPECIFIED; COD, UNSPECIFIED; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; SOLANUM LYCOPERSICUM; SACCHARIN; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; URTICA URENS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2316_ca8327a8-7713-c0cb-5c20-d93bf687cc02 55714-2316 HUMAN OTC DRUG Hyperactivity - Mental Focus Adrenalinum, Tarentula cubensis, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Cypripedium, Digitalis, Gelsemium, Humulus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Echinacea, Gingko, Hypericum, Passiflora LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; CITHARACANTHUS SPINICRUS; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MATRICARIA RECUTITA; CYPRIPEDIUM PARVIFOLUM ROOT; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HOPS; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SCUTELLARIA LATERIFLORA; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THERIDION CURASSAVICUM; ECHINACEA, UNSPECIFIED; GINKGO; HYPERICUM PERFORATUM; PASSIFLORA INCARNATA FLOWERING TOP 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2317_0934786e-01ad-b24f-54c2-3b02c82fdf26 55714-2317 HUMAN OTC DRUG Hyperactivity - Mental Focus Adrenalinum, Tarentula cubensis, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Cypripedium, Digitalis, Gelsemium, Humulus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Echinacea, Gingko, Hypericum, Passiflora PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; CITHARACANTHUS SPINICRUS; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MATRICARIA RECUTITA; CYPRIPEDIUM PARVIFOLUM ROOT; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HOPS; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SCUTELLARIA LATERIFLORA; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THERIDION CURASSAVICUM; ECHINACEA, UNSPECIFIED; GINKGO; HYPERICUM PERFORATUM; PASSIFLORA INCARNATA FLOWERING TOP 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2320_27624e01-8c96-474d-8c94-41d2b67290b3 55714-2320 HUMAN OTC DRUG Heavy Metal Detox Allium sativum, Aluminium metallicum, Arg. met., Aur. met., Baryta carb., Beryllium metallicum, Bismuthum metallicum, Cadmium metallicum, Calc. fluor., Carbo veg., Chelidonium majus, Cinchona, Cobaltum met., Cuprum met., Glycyrrhiza glabra, Hydrofluoricum acidum, Iris versicolor, Manganum metallicum, Merc. viv., Niccolum metallicum, Osmium metallicum, Platinum met., Plumb. met., Stannum met., Strontium carb., Thallium metallicum, Titanium metallicum, Carduus mar., Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. GARLIC; ALUMINUM; SILVER; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; CADMIUM; CALCIUM FLUORIDE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; COBALT; COPPER; GLYCYRRHIZA GLABRA; HYDROFLUORIC ACID; IRIS VERSICOLOR ROOT; MANGANESE; MERCURY; NICKEL; OSMIUM; PLATINUM; LEAD; TIN; STRONTIUM CARBONATE; THALLIUM; TITANIUM; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2321_ca7e9a2f-740c-481f-32ad-0a650880cdc2 55714-2321 HUMAN OTC DRUG Heavy Metal Detox Allium sativum, Aluminium metallicum, Arg. met., Aur. met., Baryta carb., Beryllium metallicum, Bismuthum metallicum, Cadmium metallicum, Calc. fluor., Carbo veg., Chelidonium majus, Cinchona, Cobaltum met., Cuprum met., Glycyrrhiza glabra, Hydrofluoricum acidum, Iris versicolor, Manganum metallicum, Merc. viv., Niccolum metallicum, Osmium metallicum, Platinum met., Plumb. met., Stannum met., Strontium carb., Thallium metallicum, Titanium metallicum, Carduus mar., Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. GARLIC; ALUMINUM; SILVER; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; CADMIUM; CALCIUM FLUORIDE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; COBALT; COPPER; GLYCYRRHIZA GLABRA; HYDROFLUORIC ACID; IRIS VERSICOLOR ROOT; MANGANESE; MERCURY; NICKEL; OSMIUM; PLATINUM; LEAD; TIN; STRONTIUM CARBONATE; THALLIUM; TITANIUM; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2322_4e12d2ba-c37e-88c7-4b6f-ab61cc71e7b2 55714-2322 HUMAN OTC DRUG Morning Sickness Bismuthum metallicum, Bryonia, Cimicifuga, Gossypium herbaceum, Ipecac., Kreosotum, Lycopodium, Mag. carb., Nux vom., Pulsatilla, Sepia, Symphoricarpus racemosus, Tabacum, Zingiber, Chamomilla, Hydrastis, Iris versicolor LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; BRYONIA ALBA ROOT; BLACK COHOSH; GOSSYPIUM HERBACEUM ROOT BARK; IPECAC; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SYMPHORICARPOS ALBUS FRUIT; TOBACCO LEAF; GINGER; MATRICARIA RECUTITA; GOLDENSEAL; IRIS VERSICOLOR ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 55714-2324_a628616c-629a-e984-9d9d-eb96fedad3e2 55714-2324 HUMAN OTC DRUG Rosacea Arsenicum alb., Arsenicum bromatum, Carbo animalis, Causticum, Hydrocotyle, Kali brom., Kali iod., Kreosotum, Lycopodium, Nux vom., Petroleum, Rhus toxicodendron, Sepia, Sulphur, Echinacea, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; ARSENIC TRIBROMIDE; CARBO ANIMALIS; CAUSTICUM; CENTELLA ASIATICA; POTASSIUM BROMIDE; POTASSIUM IODIDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; KEROSENE; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; ECHINACEA, UNSPECIFIED; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2325_bd05daf9-d80e-8db1-55d1-1489b0ed25f3 55714-2325 HUMAN OTC DRUG Rosacea Arsenicum alb., Arsenicum bromatum, Carbo animalis, Causticum, Hydrocotyle, Kali brom., Kali iod., Kreosotum, Lycopodium, Nux vom., Petroleum, Rhus toxicodendron, Sepia, Sulphur, Echinacea, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; ARSENIC TRIBROMIDE; CARBO ANIMALIS; CAUSTICUM; CENTELLA ASIATICA; POTASSIUM BROMIDE; POTASSIUM IODIDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; KEROSENE; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; ECHINACEA, UNSPECIFIED; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2328_2bb7d78c-71f9-ffd6-73f7-1c3b03075f32 55714-2328 HUMAN OTC DRUG Edema - Fluid Retention Elaps corallinus, Apis mel., Arsenicum alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus horridus, Digitalis, Juniperus com., Lachesis, Merc. viv., Naja, Nat. carb., Nat.sulphuricum, Rhus toxicodendron, Sambucus nig., Strophanthus hispidus, Thuja occ., Vipera berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica ur. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; APIS MELLIFERA; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; THUJA OCCIDENTALIS LEAFY TWIG; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; URTICA URENS 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2329_a9be2658-d722-12b7-0183-5379182f9c46 55714-2329 HUMAN OTC DRUG Edema - Fluid Retention Elaps corallinus, Apis mel., Arsenicum alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus horridus, Digitalis, Juniperus com., Lachesis, Merc. viv., Naja, Nat. carb., Nat.sulphuricum, Rhus toxicodendron, Sambucus nig., Strophanthus hispidus, Thuja occ., Vipera berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica ur. PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; APIS MELLIFERA; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; THUJA OCCIDENTALIS LEAFY TWIG; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; URTICA URENS 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2330_5f59cca7-93c9-a91c-3ae4-01604e04dcdf 55714-2330 HUMAN OTC DRUG Stress Tension Aconitum nap. ., Arg. nit. ., Aur.met., Baptisia, Bryonia, Chelidonium majus,Cimicifuga, Conium, Gelsemium, Ignatia, Kali carb., Lachesis, Lilium, Lycopodium, Nat. carb., Nat.mur., Phosphoricum ac., Phosphorus, Picricum ac.,Plumb. met., Sepia, Staphysag., Stramonium, Thujaocc., Zinc. met., Chamomilla, Hypericum, Valeriana, LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SILVER NITRATE; GOLD; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; BLACK COHOSH; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM CHLORIDE; PHOSPHORIC ACID; PHOSPHORUS; TRINITROPHENOL; LEAD; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2331_65002e3c-9fec-6ac0-441a-bcbed02ecea9 55714-2331 HUMAN OTC DRUG Stress - Tension Aconitum nap., Arg. nit., Aur.met., Baptisia, Bryonia, Chelidonium majus, Cimicifuga, Conium, Gelsemium, Ignatia, Kali carb., Lachesis, Lilium, Lycopodium, Nat. carb., Nat.mur., Phosphoricum ac., Phosphorus, Picricum ac., Plumb. met., Sepia, Staphysag., Stramonium, Thuja occ., Zinc. met., Chamomilla, Hypericum, Valeriana PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SILVER NITRATE; GOLD; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; BLACK COHOSH; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM CHLORIDE; PHOSPHORIC ACID; PHOSPHORUS; TRINITROPHENOL; LEAD; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2332_aed0c4e6-9d96-52c6-168e-7eca783813ed 55714-2332 HUMAN OTC DRUG Ear Wax Build-Up Elaps corallinus, Alumina, Carbo veg., Causticum, Conium, Graphites, Kali bic.,Kali mur., Lachesis, Lycopodium, Petroleum, Pulsatilla, Sabadilla, Sepia, Silicea, Spongia, Verbascum, Viola odorata LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; ALUMINUM OXIDE; ACTIVATED CHARCOAL; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; POTASSIUM DICHROMATE; POTASSIUM CHLORIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LIQUID PETROLEUM; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; VERBASCUM THAPSUS; VIOLA ODORATA 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2333_28dacbd0-cacf-6b3f-3dad-744ff4ed90aa 55714-2333 HUMAN OTC DRUG Ear Wax Build-Up Elaps corallinus, Alumina, Carbo veg., Causticum, Conium, Graphites, Kali bic., Kali mur., Lachesis, Lycopodium, Petroleum, Pulsatilla, Sabadilla, Sepia, Silicea, Spongia, Verbascum, Viola odorata PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; ALUMINUM OXIDE; ACTIVATED CHARCOAL; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; POTASSIUM DICHROMATE; POTASSIUM CHLORIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LIQUID PETROLEUM; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; VERBASCUM THAPSUS; VIOLA ODORATA 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2334_5165510d-5a80-aeef-fc88-5f0a7ea586a0 55714-2334 HUMAN OTC DRUG Shingles Apis mel., Arsenicum alb., Asterias rubens, Cantharis, Cistus canadensis, Croton, Dolichos, Dulcamara, Graphites, Grindelia, Hypericum, Iris versicolor, Lycopodium, Mezereum, Ranunc. bulb., Rhus toxicodendron, Staphysag., Sulphur, Thuja occ., Zinc. met., Chamomilla, Echinacea. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ASTERIAS RUBENS; LYTTA VESICATORIA; HELIANTHEMUM CANADENSE; CROTON TIGLIUM SEED; MUCUNA PRURIENS FRUIT TRICHOME; SOLANUM DULCAMARA TOP; GRAPHITE; GRINDELIA HIRSUTULA FLOWERING TOP; HYPERICUM PERFORATUM; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ZINC; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2335_6d6238e2-bf6b-a03e-4141-753b35d6e8c6 55714-2335 HUMAN OTC DRUG Shingles Apis mel., Arsenicum alb., Asterias rubens, Cantharis, Cistus canadensis, Croton, Dolichos, Dulcamara, Graphites, Grindelia, Hypericum, Iris versicolor, Lycopodium, Mezereum, Ranunc. bulb., Rhus toxicodendron, Staphysag., Sulphur, Thuja occ., Zinc. met., Chamomilla, Echinacea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; ASTERIAS RUBENS; LYTTA VESICATORIA; HELIANTHEMUM CANADENSE; CROTON TIGLIUM SEED; MUCUNA PRURIENS FRUIT TRICHOME; SOLANUM DULCAMARA TOP; GRAPHITE; GRINDELIA HIRSUTULA FLOWERING TOP; HYPERICUM PERFORATUM; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ZINC; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2338_5c75907a-76e8-7d78-e053-2991aa0a5b67 55714-2338 HUMAN OTC DRUG Blues - Mood - Emotions Angelica sinensis radix, Aralia quinquefolia, Arg. nit., Arsenicum alb., Berber. aqui., Capsicum , Cinchona, Digitalis, Gelsemium, Hypericum, Ignatia, Iodium, Kali brom., Kali carb., Mag. phos., Nat. carb., Nat. mur., Phosphorus, Salix nigra, Sanguinaria, Sepia, Stramonium, Echinacea, Ginkgo LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANGELICA SINENSIS ROOT; AMERICAN GINSENG; SILVER NITRATE; ARSENIC TRIOXIDE; CAPSICUM; CINCHONA OFFICINALIS BARK; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IODINE; POTASSIUM BROMIDE; POTASSIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CARBONATE; SODIUM CHLORIDE; PHOSPHORUS; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; ECHINACEA, UNSPECIFIED; GINKGO; MAHONIA AQUIFOLIUM ROOT BARK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2339_5c76017a-45f7-e4d1-e053-2a91aa0a143e 55714-2339 HUMAN OTC DRUG Blues - Mood - Emotions Angelica sinensis radix, Aralia quinquefolia, Arg. nit., Arsenicum alb., Berber. aqui., Capsicum , Cinchona, Digitalis, Gelsemium, Hypericum, Ignatia, Iodium, Kali brom., Kali carb., Mag. phos., Nat. carb., Nat. mur., Phosphorus, Salix nigra, Sanguinaria, Sepia, Stramonium, Echinacea, Ginkgo PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANGELICA SINENSIS ROOT; AMERICAN GINSENG; SILVER NITRATE; ARSENIC TRIOXIDE; CAPSICUM; CINCHONA OFFICINALIS BARK; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IODINE; POTASSIUM BROMIDE; POTASSIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CARBONATE; SODIUM CHLORIDE; PHOSPHORUS; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; ECHINACEA, UNSPECIFIED; GINKGO; MAHONIA AQUIFOLIUM ROOT BARK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2342_674d2f3e-0a8d-9991-cf13-03937246c079 55714-2342 HUMAN OTC DRUG Ear Ringing Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata, Hydrastis. LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; DYSPHANIA AMBROSIOIDES; QUININE SULFATE; CINCHONA OFFICINALIS BARK; NITROGLYCERIN; GRAPHITE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; SALICYLIC ACID; TOBACCO LEAF; ALLYLTHIOUREA; VIOLA ODORATA; GOLDENSEAL 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2343_6b005914-c0df-84b6-2125-6b2740fcec23 55714-2343 HUMAN OTC DRUG Ear Ringing Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac., Tabacum, Thiosinaminum, Viola odorata PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; DYSPHANIA AMBROSIOIDES; QUININE SULFATE; CINCHONA OFFICINALIS BARK; NITROGLYCERIN; GRAPHITE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; SALICYLIC ACID; TOBACCO LEAF; ALLYLTHIOUREA; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2348_8adac974-ff77-7d4f-a4cf-5e8882d6415f 55714-2348 HUMAN OTC DRUG Restless Leg Mygale, Agaricus musc., Causticum, Cinchona, Conium, Cuprum met., Gelsemium, Hyoscyamus, Hypericum, Kali carb., Mag. carb., Merc. viv., Nux vom., Plumb. met., Rhus toxicodendron, Secale, Strychninum, Tarentula hispana, Valeriana, Verbascum, Zinc. met., Chamomilla,Passiflora LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AVICULARIA AVICULARIA; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; MERCURY; STRYCHNOS NUX-VOMICA SEED; LEAD; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM; STRYCHNINE; LYCOSA TARANTULA; VALERIAN; VERBASCUM THAPSUS; ZINC; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2349_e7ab1a31-ff88-f34b-5ea3-c8bd7371f064 55714-2349 HUMAN OTC DRUG Restless Leg Mygale, Agaricus musc., Causticum, Cinchona, Conium, Cuprum met., Gelsemium, Hyoscyamus, Hypericum, Kali carb., Mag. carb., Merc. viv., Nux vom., Plumb. met., Rhus toxicodendron, Secale, Strychninum, Tarentula hispana, Valeriana, Verbascum, Zinc. met., Chamomilla,Passiflora PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AVICULARIA AVICULARIA; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; MERCURY; STRYCHNOS NUX-VOMICA SEED; LEAD; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM; STRYCHNINE; LYCOSA TARANTULA; VALERIAN; VERBASCUM THAPSUS; ZINC; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2350_39a94f92-80ab-2615-2dd5-a93cad659620 55714-2350 HUMAN OTC DRUG Vitiligo Arsenicum alb., Berber. vulg., Bovista, Dolichos, Echinacea, Hura brasiliensis, Hydrocotyle, Lycopodium, Mezereum, Rhus toxicodendron, Rumex crisp., Sepia, Taraxacum,Thuja occ., Urtica ur., Iris versicolor LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; MUCUNA PRURIENS FRUIT TRICHOME; ECHINACEA, UNSPECIFIED; HURA CREPITANS SAP; CENTELLA ASIATICA; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; IRIS VERSICOLOR ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2351_ede8eff5-df1c-cb37-bc53-711662e5025d 55714-2351 HUMAN OTC DRUG Vitiligo Arsenicum alb., Berber. vulg., Bovista, Dolichos, Echinacea, Hura brasiliensis, Hydrocotyle, Lycopodium, Mezereum, Rhus toxicodendron, Rumex crisp., Sepia, Taraxacum,Thuja occ., Urtica ur., Iris versicolor PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; MUCUNA PRURIENS FRUIT TRICHOME; ECHINACEA, UNSPECIFIED; HURA CREPITANS SAP; CENTELLA ASIATICA; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; IRIS VERSICOLOR ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2354_d57f0aa0-9085-b724-08f0-6cd1f7338332 55714-2354 HUMAN OTC DRUG Cell Salts Calc. fluor., Calc. phos., Calc.sulph., Ferrum phosphoricum, Kali mur., Kali phos., Kali sulph., Mag. phos., Nat. mur., Nat. phos., Nat.sulphuricum, Silicea LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2355_504e5a6b-69c6-daaa-873a-aee37d5bba5c 55714-2355 HUMAN OTC DRUG Cell Salts Calc. fluor., Calc. phos., Calc.sulph., Ferrum phosphoricum, Kali mur., Kali phos., Kali sulph., Mag. phos., Nat. mur., Nat. phos., Nat.sulphuricum, Silicea PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CALCIUM FLUORIDE; PHOSPHATE ION; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2364_9755751e-a450-fc35-7ea0-e35d07fc33e4 55714-2364 HUMAN OTC DRUG Vitality Adrenalinum, Aloe, Arsenicum alb., Baptisia, Berber. Aqui., Berber. vulg., Bryonia, Chelidonium majus, Crotalus horridus, Digitalis, Ferrum metallicum, Glonoinum, Glycyrrhiza glabra , Hydrocotyle, Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. mur., Nux vom., Rhus toxicodendron, Ruta, Thuja occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum LIQUID ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; ALOE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2365_6a064c42-aae1-c575-2463-6e276bb3c73a 55714-2365 HUMAN OTC DRUG Vitality Adrenalinum, Aloe, Arsenicum alb., Baptisia, Berber. Aqui., Berber. vulg., Bryonia, Chelidonium majus, Crotalus horridus, Digitalis, Ferrum metallicum, Glonoinum, Glycyrrhiza glabra , Hydrocotyle, Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. mur., Nux vom., Rhus toxicodendron, Ruta, Thuja occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum PELLET ORAL 20110301 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; ALOE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2366_4120deb4-3543-419f-7394-1eb8208297ad 55714-2366 HUMAN OTC DRUG Natural Response Aconitum nap., Arnica, Arsenicum alb., Bryonia, Echinacea, Ledum, Cenchris, Crotalus casc. Crotalus hor., Lachesis, Merc. corros., Naja, Phos., Toxicophis, Vipera, Elaps cor., Heloderma LIQUID ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; ECHINACEA, UNSPECIFIED; LEDUM PALUSTRE TWIG; AGKISTRODON CONTORTRIX VENOM; CROTALUS DURISSUS TERRIFICUS VENOM; CROTALUS HORRIDUS HORRIDUS VENOM; LACHESIS MUTA VENOM; MERCURIC CHLORIDE; NAJA NAJA VENOM; PHOSPHORUS; AGKISTRODON PISCIVORUS VENOM; VIPERA BERUS VENOM; MICRURUS CORALLINUS VENOM; HELODERMA SUSPECTUM VENOM 10; 10; 10; 10; 10; 10; 15; 15; 15; 15; 15; 15; 15; 15; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2367_bcb97377-de7d-6300-5e43-da545227e306 55714-2367 HUMAN OTC DRUG Natural Response Aconitum nap., Arnica, Arsenicum alb., Bryonia, Echinacea, Ledum, Cenchris, Crotalus casc. Crotalus hor., Lachesis, Merc. corros., Naja, Phos., Toxicophis, Vipera, Elaps cor., Heloderma PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; ECHINACEA, UNSPECIFIED; LEDUM PALUSTRE TWIG; AGKISTRODON CONTORTRIX VENOM; CROTALUS DURISSUS TERRIFICUS VENOM; CROTALUS HORRIDUS HORRIDUS VENOM; LACHESIS MUTA VENOM; MERCURIC CHLORIDE; NAJA NAJA VENOM; PHOSPHORUS; AGKISTRODON PISCIVORUS VENOM; VIPERA BERUS VENOM; MICRURUS CORALLINUS VENOM; HELODERMA SUSPECTUM VENOM 10; 10; 10; 10; 10; 10; 15; 15; 15; 15; 15; 15; 15; 15; 15; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2368_41578178-474b-4906-f325-2ae16b3b5326 55714-2368 HUMAN OTC DRUG Complementary Complex Influenzinum, Anthracinum, Arnica, Belladonna, Aconitum nap., Arsenicum alb., Baptisia, Bryonia, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc. viv., Nux vom., Phos., Pulsatilla, Rhus tox., Apis mel., Echinacea, Hydrastis, Thuja occ., Aaricus musc,. Allium sat., Aloe, Calc. carb., Calendula, Capiscum, Carduus mar., Salvia, Selenium, Taraxacum, Tarentula hisp., Zinc. met., Zingiber LIQUID ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG; ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; GARLIC; ALOE; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; MILK THISTLE; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAGE; SELENIUM; TARAXACUM OFFICINALE; LYCOSA TARANTULA; ZINC; GINGER; BACILLUS ANTHRACIS; INFLUENZA A VIRUS; INFLUENZA B VIRUS 3; 3; 3; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2369_89894d18-29d2-b15d-ef1c-e7bde9809f65 55714-2369 HUMAN OTC DRUG Complementary Complex Influenzinum, Anthracinum, Arnica, Belladonna, Aconitum nap., Arsenicum alb., Baptisia, Bryonia, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc. viv., Nux vom., Phos., Pulsatilla, Rhus tox., Apis mel., Echinacea, Hydrastis, Thuja occ., Aaricus musc,. Allium sat., Aloe, Calc. carb., Calendula, Capiscum, Carduus mar., Salvia, Selenium, Taraxacum, Tarentula hisp., Zinc. met., Zingiber PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG; ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; GARLIC; ALOE; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; MILK THISTLE; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAGE; SELENIUM; TARAXACUM OFFICINALE; LYCOSA TARANTULA; ZINC; GINGER; BACILLUS ANTHRACIS; INFLUENZA A VIRUS; INFLUENZA B VIRUS 3; 3; 3; 3; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2370_60677678-b54b-c030-e053-2a91aa0a9850 55714-2370 HUMAN OTC DRUG Thyroid Care Adrenalinum, Thyroidinum, Aloe, Calc. carb., Chelidonium majus, Conium, Graphites, Iodium, Lachesis, Lycopodium, Lycopus virginicus, Phytolacca, Rhus toxicodendron, Silicea, Spongia, Echinacea LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; THYROID, UNSPECIFIED; ALOE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; ECHINACEA, UNSPECIFIED 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2371_60682b0c-49ce-1728-e053-2991aa0aa792 55714-2371 HUMAN OTC DRUG Thyroid Care Adrenalinum, Thyroidinum, Aloe, Calc. carb., Chelidonium majus, Conium, Graphites, Iodium, Lachesis, Lycopodium, Lycopus virginicus, Phytolacca, Rhus toxicodendron, Silicea, Spongia, Echinacea PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; THYROID, UNSPECIFIED; ALOE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; ECHINACEA, UNSPECIFIED 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2372_60548842-4cbb-7649-e053-2a91aa0a1a97 55714-2372 HUMAN OTC DRUG Lymphatic Care Asterias rubens, Aur. met., Belladonna, Benzoicum acidum, Berber. vulg., Bryonia, Calc. carb., Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Iris versicolor, Nat. carb., Nux vom., Ptelea, Carduus mar., Echinacea, Solidago, Taraxacum LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ASTERIAS RUBENS; GOLD; ATROPA BELLADONNA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; ECHINACEA, UNSPECIFIED; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2373_6054f1c3-ba6b-7c35-e053-2a91aa0aecee 55714-2373 HUMAN OTC DRUG Lymphatic Care Asterias rubens, Aur. met., Belladonna, Benzoicum acidum, Berber. vulg., Bryonia, Calc. carb., Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Iris versicolor, Nat. carb., Nux vom., Ptelea, Carduus mar., Echinacea, Solidago, Taraxacum PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ASTERIAS RUBENS; GOLD; ATROPA BELLADONNA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; ECHINACEA, UNSPECIFIED; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2374_5f9f6a83-2702-3a0c-e053-2a91aa0af190 55714-2374 HUMAN OTC DRUG Breast Care Bufo rana, Apis mel., Asterias rubens, Belladonna, Bryonia, Calc. carb., Chamomilla, Chimaphila umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias dioica, Lachesis, Merc. viv., Phellandrium aquaticum Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, Taraxacum LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BUFO BUFO CUTANEOUS GLAND; APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CHIMAPHILA UMBELLATA; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; LACHESIS MUTA VENOM; MERCURY; OENANTHE AQUATICA FRUIT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2375_5f9fb390-d8ea-6199-e053-2991aa0a61c5 55714-2375 HUMAN OTC DRUG Breast Care Bufo rana, Apis mel., Asterias rubens, Belladonna, Bryonia, Calc. carb., Chamomilla, Chimaphila umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias dioica, Lachesis, Merc. viv., Phellandrium aquaticum Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, Taraxacum PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BUFO BUFO CUTANEOUS GLAND; APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CHIMAPHILA UMBELLATA; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; LACHESIS MUTA VENOM; MERCURY; OENANTHE AQUATICA FRUIT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2376_6040cdca-344c-2031-e053-2a91aa0a61fe 55714-2376 HUMAN OTC DRUG Cough - Airway Influenza A Virus, Influenza B Virus, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb.,Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phosphorus, Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago farfara, Verbascum, Echinacea, Lappa LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA FLOWERING TOP; EUCALYPTUS GLOBULUS LEAF; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; POTASSIUM IODIDE; MYRRH; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; TUSSILAGO FARFARA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2377_6051717b-5ee1-c851-e053-2991aa0a6ed2 55714-2377 HUMAN OTC DRUG Cough - Airway Influenza A Virus, Influenza B Virus, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb.,Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phosphorus, Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago farfara, Verbascum, Echinacea, Lappa PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA FLOWERING TOP; EUCALYPTUS GLOBULUS LEAF; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; POTASSIUM IODIDE; MYRRH; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; TUSSILAGO FARFARA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-2378_6063c8c1-6ccf-7560-e053-2991aa0a7de4 55714-2378 HUMAN OTC DRUG Morning Sickness - Nausea Bismuthum metallicum, Bryonia, Cimicifuga, Gossypium herbaceum, Ipecac., Kreosotum, Lycopodium, Mag. carb., Nux vom., Pulsatilla, Sepia, Symphoricarpus racemosus, Tabacum, Zingiber, Chamomilla, Hydrastis, Iris versicolor LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; BRYONIA ALBA ROOT; BLACK COHOSH; GOSSYPIUM HERBACEUM ROOT BARK; IPECAC; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SYMPHORICARPOS ALBUS FRUIT; TOBACCO LEAF; GINGER; MATRICARIA RECUTITA; GOLDENSEAL; IRIS VERSICOLOR ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-2379_60645c63-bb65-49ea-e053-2a91aa0aeea6 55714-2379 HUMAN OTC DRUG Morning Sickness - Nausea Bismuthum metallicum, Bryonia, Cimicifuga, Gossypium herbaceum, Ipecac., Kreosotum, Lycopodium, Mag. carb., Nux vom., Pulsatilla, Sepia, Symphoricarpus racemosus, Tabacum, Zingiber, Chamomilla, Hydrastis, Iris versicolor PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; BRYONIA ALBA ROOT; BLACK COHOSH; GOSSYPIUM HERBACEUM ROOT BARK; IPECAC; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SYMPHORICARPOS ALBUS FRUIT; TOBACCO LEAF; GINGER; MATRICARIA RECUTITA; GOLDENSEAL; IRIS VERSICOLOR ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-4400_e821e739-51c3-3c48-421b-2c8230efefd6 55714-4400 HUMAN PRESCRIPTION DRUG Drainer BENZOIC ACIDUM, BERBERIS VULG., BRYONIA, CANTHARIS,CARDUUS BENEDICTUS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DIOSCOREA, DOLICHOS, IRIS VERSICOLOR, JUNIPERUS COM., NUX VOM., PTELEA, TARAXACUM, URICUM ACIDUM, CARDUUS MAR., CYNARA SCOLYMUS, SOLIDAGO, TARAXACUM LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CNICUS BENEDICTUS; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; URIC ACID; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 55714-4401_f4361cbe-7f48-4dd2-ff0c-b2dc9d310f64 55714-4401 HUMAN PRESCRIPTION DRUG Drainer BENZOICUM ACIDUM, BERBERIS VULG., BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DIOSCOREA, DOLICHOS, IRIS VERSICOLOR, JUNIPERUS COM., NUX VOM., PTELEA, TARAXACUM, URICUM ACIDUM, CARDUUS MAR., CYNARA SCOLYMUS, SOLIDAGO PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; URIC ACID; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4402_3cbecb6e-2002-8de8-bee3-c612623eb03c 55714-4402 HUMAN PRESCRIPTION DRUG Eczema Skin Care Antimon. crud., Arsenicum alb., Berber. vulg., Bovista , Bryonia , Cantharis , Chelidonium majus, Croton, Dulcamara, Graphites, Hepar sulph. calc., Lycopodium Mezereum, Nux vom, Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur iod, Echinacea, Rumex crisp., Taraxacum , Urtica ur., Echinacea, Rumex crisp., Taraxacum, Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULEX IRRITANS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SEPIA OFFICINALIS JUICE; SULFUR IODIDE; ECHINACEA ANGUSTIFOLIA; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS; ECHINACEA ANGUSTIFOLIA; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 8; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4403_f7b98d1a-b8fd-de73-5383-a38ad69e15bc 55714-4403 HUMAN PRESCRIPTION DRUG Eczema Skin Care Antimon. crud., Arsenicum alb., Berber. vulg., Bovista , Bryonia , Cantharis , Chelidonium majus, Croton, Dulcamara, Graphites, Hepar sulph. calc., Lycopodium Mezereum, Nux vom, Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur iod, Echinacea, Rumex crisp., Taraxacum , Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULEX IRRITANS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SEPIA OFFICINALIS JUICE; SULFUR IODIDE; ECHINACEA, UNSPECIFIED; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4404_063cfb19-5187-5b49-86e6-a441848f6c97 55714-4404 HUMAN PRESCRIPTION DRUG Insomnia Absinthium, Anacardium occidentale, Arg. nit., Arsenicum alb., Belladonna, Bryonia,Calc. carb., Camphora, Chamomilla, Cimicifuga,Cinchona, Coffea cruda, Cypripedium, Gelsemium,Humulus, Hyoscyamus, Ignatia, Kali brom., Nuxvom., Passiflora, Pulsatilla, Scutellaria lateriflora,Sepia, Thuja occ., Passiflora, aleriana, Passiflora,Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. WORMWOOD; ANACARDIUM OCCIDENTALE FRUIT; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAMPHOR (NATURAL); MATRICARIA RECUTITA; BLACK COHOSH; CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4405_0157ca9d-4027-bf16-8e47-f4e52e76548b 55714-4405 HUMAN PRESCRIPTION DRUG Insomnia Absinthium, Anacardium occidentale, Arg. nit., Arsenicum alb., Belladonna, Bryonia, Calc. carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali brom., Nux vom., Passiflora, Pulsatilla, Scutellaria lateriflora, Sepia, Thuja occ., Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. WORMWOOD; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAMPHOR (NATURAL); MATRICARIA RECUTITA; BLACK COHOSH; CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4406_dd2e364d-9f27-9e02-970e-1d3986f51593 55714-4406 HUMAN PRESCRIPTION DRUG Bronchitis-Asthma Influenza A Virus, Influenza B Virus, Antimon. tart., Arsenicum alb., Bryonia, Camphora, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Hepar sulph. calc., Histaminum hydrochloricum, Ipecac., Kali bic., Kali carb., Kali iod., Lycopodium, Myrrha, Natrum sulphuricum, Nux vom., Phosphorus, Pulsatilla, Sanguinaria, Spongia , Stannum met., Tussilago farfara, Verbascum, Echinacea, Lappa, Rumex crisp. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA; EUCALYPTUS GLOBULUS LEAF; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; IPECAC; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; MYRRH; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN; TUSSILAGO FARFARA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; RUMEX CRISPUS ROOT; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4407_4e0446dd-eef0-bab4-8096-85d3b79f4263 55714-4407 HUMAN PRESCRIPTION DRUG Bronchitis - Asthma Influenza A Virus, Influenza B Virus, Antimon. tart., Arsenicum alb., Bryonia, Camphora, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Hepar sulph. calc., Histaminum hydrochloricum, Ipecac., Kali bic., Kali carb., Kali iod., Lycopodium, Myrrha, Natrum sulphuricum, Nux vom., Phosphorus, Pulsatilla, Sanguinaria, Spongia , Stannum met., Tussilago farfara, Verbascum, Echinacea, Lappa, Rumex crisp. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA; EUCALYPTUS GLOBULUS LEAF; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; IPECAC; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; MYRRH; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN; TUSSILAGO FARFARA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; RUMEX CRISPUS ROOT; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4408_70cfb514-bffb-d423-f8c3-88aaadc2d038 55714-4408 HUMAN PRESCRIPTION DRUG Fear Phobia Aconitum nap., Anacardium orientale, Arg. nit., Arsenicum alb., Cypripedium,Gelsemium, Ignatia, Kali carb., Lycopodium, Nat. mur., Phosphorus, Sambucus nig., Sepia, Staphysag., Stramonium, Tarentula hispana,Theridion, Passiflora, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ARSENIC TRIOXIDE; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; LYCOSA TARANTULA; THERIDION CURASSAVICUM; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-4409_4a41b715-1278-161d-f6f5-c5e6af9ea25f 55714-4409 HUMAN PRESCRIPTION DRUG Fear Phobia Aconitum nap., Anacardium orientale, Arg. nit., Arsenicum alb., Cypripedium,Gelsemium, Ignatia, Kali carb., Lycopodium, Nat. mur., Phosphorus, Sambucus nig., Sepia, Staphysag., Stramonium, Tarentula hispana,Theridion, Passiflora, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ARSENIC TRIOXIDE; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; SAMBUCUS NIGRA FLOWERING TOP; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; LYCOSA TARANTULA; THERIDION CURASSAVICUM; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-4410_06faf3ae-4a98-de13-5769-84f8ae25d1c7 55714-4410 HUMAN PRESCRIPTION DRUG Influenza Influenzinum (combo), Histaminum hydrochloricum, Aconitum nap., Aralia quinquefolia, Arsenicum alb., Baptisia, Bryonia, Cinchona, Eupatorium perf., Gelsemium, Ipecac., Kali carb., Nux vom., Phosphorus, Rhus toxicodendron, Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; INFLUENZA B VIRUS; HISTAMINE DIHYDROCHLORIDE; ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; ECHINACEA, UNSPECIFIED 35; 35; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4411_66fbda09-3253-1869-cc90-a412535c419c 55714-4411 HUMAN PRESCRIPTION DRUG Influenza Influenzinum (combo), Histaminum hydrochloricum, Aconitum nap., Aralia quinquefolia, Arsenicum alb., Baptisia, Bryonia, Cinchona, Eupatorium perf., Gelsemium, Ipecac., Kali carb., Nux vom., Phosphorus, Rhus toxicodendron, Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; INFLUENZA B VIRUS; HISTAMINE DIHYDROCHLORIDE; ACONITUM NAPELLUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; ECHINACEA, UNSPECIFIED 35; 35; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4416_a54763fa-079d-2c5e-9b0b-ebc30284d3c8 55714-4416 HUMAN PRESCRIPTION DRUG Ear Care Influenzinum, Tellurium metallicum, Apis mel, Arsenicum alb., Belladonna, Bryonia, Capsicum, Causticum, Cinchona, Conium, Dulcamara, Ferrum phosphoricum, Hepar sulph. calc., Kali sulph., Lycopodium, Merc. viv., Mezereum, Phosphorus, Plantago, Pulsatilla, Silicea, Verbascum, Echinacea, Hydrastis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; TELLURIUM; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA STEM; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM SULFATE; LYCOPODIUM CLAVATUM SPORE; MERCURY; DAPHNE MEZEREUM BARK; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILICON DIOXIDE; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55714-4417_5f438ba2-99ca-d4e1-344c-b09c11e9cd67 55714-4417 HUMAN PRESCRIPTION DRUG Ear Care Influenzinum, Tellurium metallicum, Apis mel, Arsenicum alb., Belladonna, Bryonia, Capsicum, Causticum, Cinchona, Conium, Dulcamara, Ferrum phosphoricum, Hepar sulph. calc., Kali sulph., Lycopodium, Merc. viv., Mezereum, Phosphorus, Plantago, Pulsatilla, Silicea, Verbascum, Echinacea, Hydrastis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; TELLURIUM; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA STEM; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM SULFATE; LYCOPODIUM CLAVATUM SPORE; MERCURY; DAPHNE MEZEREUM BARK; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILICON DIOXIDE; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55714-4418_75a1924e-9293-110e-905c-4ecef365bb9e 55714-4418 HUMAN PRESCRIPTION DRUG Sinusitis Arsenicum iodatum, Bryonia, Cistus canadensis, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Iodium, Kali bic., Kali iod., Merc. iod. rub., Merc. viv., Nux vom., Phosphorus, Pulsatilla, Sabadilla, Sticta, Verbascum, Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; HELIANTHEMUM CANADENSE; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; IODINE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; MERCURIC IODIDE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4419_81dde272-406f-e6a1-a936-d3804b4b7de5 55714-4419 HUMAN PRESCRIPTION DRUG Sinusitis Arsenicum iodatum, Bryonia, Cistus canadensis, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Iodium, Kali bic., Kali iod., Merc. iod. rub., Merc. viv., Nux vom., Phosphorus, Pulsatilla, Sabadilla, Sticta, Verbascum, Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; HELIANTHEMUM CANADENSE; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; IODINE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; MERCURIC IODIDE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4420_3bee5240-8977-e937-690d-a5556d7d7292 55714-4420 HUMAN PRESCRIPTION DRUG Cold Cough Influenzinum, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procumbens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea, Hydrastis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SAGE; LOBARIA PULMONARIA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS 35; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 35 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 55714-4421_b6445d2c-28e3-5e2b-8a4c-91fbf8465ae1 55714-4421 HUMAN PRESCRIPTION DRUG Cold - Cough Influenzinum, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procumbens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SAGE; LOBARIA PULMONARIA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS 35; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 35 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 55714-4424_f886f05e-a0ff-fbe4-8213-f31d1fd99f45 55714-4424 HUMAN PRESCRIPTION DRUG Hypertension Elaps corallinus, Adrenalinum, Arsenicum iodatum , Aur. met., Baryta carb., Bryonia, Cactus, Chelidonium majus, Cinchona, Crotalus horridus, Digitalis, Glonoinum, Kali carb., Kali iod ., Lachesis , Naja , Nux vom., Veratrum alb., Vipera berus, Viscum, Ruta, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; EPINEPHRINE; ARSENIC TRIIODIDE; GOLD; BARIUM CARBONATE; BRYONIA ALBA ROOT; SELENICEREUS GRANDIFLORUS STEM; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; NITROGLYCERIN; POTASSIUM CARBONATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT; VIPERA BERUS VENOM; VISCUM ALBUM FRUITING TOP; RUTA GRAVEOLENS FLOWERING TOP; VALERIAN 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4425_d0ae71ca-571d-8cd5-9542-93ade77dc7bc 55714-4425 HUMAN PRESCRIPTION DRUG Hypertension Elaps corallinus, Adrenalinum, Arsenicum iodatum , Aur. met., Baryta carb., Bryonia, Cactus, Chelidonium majus, Cinchona, Crotalus horridus, Digitalis, Glonoinum, Kali carb., Kali iod ., Lachesis , Naja , Nux vom., Veratrum alb., Vipera berus, Viscum, Ruta, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; EPINEPHRINE; ARSENIC TRIIODIDE; GOLD; BARIUM CARBONATE; BRYONIA ALBA ROOT; SELENICEREUS GRANDIFLORUS STEM; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; NITROGLYCERIN; POTASSIUM CARBONATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT; VIPERA BERUS VENOM; VISCUM ALBUM FRUITING TOP; RUTA GRAVEOLENS FLOWERING TOP; VALERIAN 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4426_3a9e31c6-762d-5d31-d974-f8c31e1c6869 55714-4426 HUMAN PRESCRIPTION DRUG Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia, Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc. met., Echinacea, Iris versicolor, Phytolacca, Taraxacum, LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. PICEA MARIANA RESIN; HORSE CHESTNUT; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; GRAPHITE; GOLDENSEAL; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; FRANGULA PURSHIANA BARK; SANICULA EUROPAEA WHOLE; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 8; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 55714-4427_e884e313-298e-fbca-b877-71a3e227b886 55714-4427 HUMAN PRESCRIPTION DRUG Constipation Abies nig., Aesculus hipp., Aloe, Alumina, Bryonia, Carbo veg., Chelidonium majus, Collinsonia, Graphites, Hydrastis, Kali carb., Lycopodium, Mag. mur., Mezereum, Nux vom., Podoph. pelt., Rhamnus purshiana, Sanicula, Selenium, Sepia, Silicea, Tabacum, Veratrum alb., Zinc. met., Echinacea, Iris versicolor, Phytolacca, Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. PICEA MARIANA RESIN; HORSE CHESTNUT; ALOE; ALUMINUM OXIDE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; GRAPHITE; GOLDENSEAL; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; FRANGULA PURSHIANA BARK; SANICULA EUROPAEA WHOLE; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TOBACCO LEAF; VERATRUM ALBUM ROOT; ZINC; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 55714-4428_ccc38a3b-5a91-19ed-8eba-cb5832d5c91a 55714-4428 HUMAN PRESCRIPTION DRUG Diabetes Arg. met., Arsenicum alb, Aur. met., Bovista, Bryonia, Chelidonium majus, Chionanthus virginica, Gaultheria procumbens, Helonias dioica, Iris versicolor, Lycopodium, Nux vom, Phosphorus, Rhus toxicodendron, Sabal, Syzygium, Cynara, Echinacea, Iris versicolor, Thuja occ., Urtica ur LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. SILVER; ARSENIC TRIOXIDE; GOLD; GIANT PUFFBALL; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; GAULTHERIA PROCUMBENS TOP; CHAMAELIRIUM LUTEUM ROOT; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; SYZYGIUM CUMINI SEED; CYNARA SCOLYMUS LEAF; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4429_7d7e957e-22dd-a3a6-810e-1b8883e6e799 55714-4429 HUMAN PRESCRIPTION DRUG Diabetes Arg. met., Arsenicum alb, Aur. met., Bovista, Bryonia, Chelidonium majus, Chionanthus virginica, Gaultheria procumbens, Helonias dioica, Iris versicolor, Lycopodium, Nux vom, Phosphorus, Rhus toxicodendron, Sabal, Syzygium, Cynara, Echinacea, Thuja occ., Urtica ur PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. SILVER; ARSENIC TRIOXIDE; GOLD; GIANT PUFFBALL; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; GAULTHERIA PROCUMBENS TOP; CHAMAELIRIUM LUTEUM ROOT; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; SYZYGIUM CUMINI SEED; CYNARA SCOLYMUS LEAF; ECHINACEA, UNSPECIFIED; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4430_45cd1364-38bf-b552-545a-a628c3dea4f6 55714-4430 HUMAN PRESCRIPTION DRUG Arthritic Joint Care Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Benzoicum acidum,Bryonia, Calc. carb., Chamomilla, Cinchona, Colchicum, Eupatorium perf., Gaultheria procumbens, Guaiacum, Iodium, Kali bic., Kalmia, Ledum,Pulsatilla, Rhus xicodendron, Ruta, Sabina, Strychninum, Uricum acidum, Lappa, Phytolacca, Symphytum, LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; EUPATORIUM PERFOLIATUM FLOWERING TOP; GAULTHERIA PROCUMBENS TOP; GUAIAC; IODINE; POTASSIUM DICHROMATE; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; JUNIPERUS SABINA LEAFY TWIG; STRYCHNINE; URIC ACID; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55714-4431_dc0b72f7-dff4-14d8-1a92-e29dd1960cac 55714-4431 HUMAN PRESCRIPTION DRUG Arthritic - Joint Care Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Benzoicum acidum,Bryonia, Calc. carb., Chamomilla, Cinchona, Colchicum, Eupatorium perf., Gaultheria procumbens, Guaiacum, Iodium, Kali bic., Kalmia, Ledum,Pulsatilla, Rhus xicodendron, Ruta, Sabina, Strychninum, Uricum acidum, Lappa, Phytolacca, Symphytum, PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; EUPATORIUM PERFOLIATUM FLOWERING TOP; GAULTHERIA PROCUMBENS TOP; GUAIAC; IODINE; POTASSIUM DICHROMATE; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; JUNIPERUS SABINA LEAFY TWIG; STRYCHNINE; URIC ACID; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 55714-4432_bec9c8bf-a165-fc44-0cb7-691b54d1142d 55714-4432 HUMAN PRESCRIPTION DRUG Hay Fever Zerophyllum asphodeloides, Alfalfa, Avena sativa pollen, Cynosurus cristatus pollen, Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen, Alopecurus pratensis pollen, Phleum pratense pollen, Festuca pratensis pollen, Holcus lanatus pollen, Lolium perenne pollen, Fagus sylvatica pollen, Betula pendula pollen, Quercus alba pollen, Fraxinus excelsior pollen, Corylus americana pollen, Populus nigra pollen LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. XEROPHYLLUM ASPHODELOIDES; ALFALFA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; ACONITUM NAPELLUS; ARUNDO PLINIANA ROOT; DYSPHANIA AMBROSIOIDES; HELIANTHEMUM CANADENSE; DROSERA ROTUNDIFOLIA; SOLANUM DULCAMARA TOP; LEDUM PALUSTRE TWIG; ONOSMODIUM VIRGINIANUM WHOLE; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; DATURA STRAMONIUM; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; ONION; AMBROSIA ARTEMISIIFOLIA; AMMONIUM CARBONATE; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; TRILLIUM ERECTUM ROOT; USTILAGO MAYDIS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; TARAXACUM OFFICINALE 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] N 20181231 55714-4433_15558d31-b09a-c23d-43f9-c3fb8aa45f7d 55714-4433 HUMAN PRESCRIPTION DRUG Hay Fever Zerophyllum asphodeloides, Alfalfa, Avena sativa pollen, Cynosurus cristatus pollen, Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen, Alopecurus pratensis pollen, Phleum pratense pollen, Festuca pratensis pollen, Holcus lanatus pollen, Lolium perenne pollen, Fagus sylvatica pollen, Betula pendula pollen, Quercus alba pollen, Fraxinus excelsior pollen, Corylus americana pollen, Populus nigra pollen PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. XEROPHYLLUM ASPHODELOIDES; ALFALFA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; ACONITUM NAPELLUS; ARUNDO PLINIANA ROOT; DYSPHANIA AMBROSIOIDES; HELIANTHEMUM CANADENSE; DROSERA ROTUNDIFOLIA; SOLANUM DULCAMARA TOP; LEDUM PALUSTRE TWIG; ONOSMODIUM VIRGINIANUM WHOLE; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; DATURA STRAMONIUM; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; ONION; AMBROSIA ARTEMISIIFOLIA; AMMONIUM CARBONATE; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; TRILLIUM ERECTUM ROOT; USTILAGO MAYDIS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; TARAXACUM OFFICINALE 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE] N 20181231 55714-4438_b006ceaa-4794-5eb1-ded5-138cfadd85c7 55714-4438 HUMAN PRESCRIPTION DRUG Gas Indigestion Pyrogenium, Antimon. crud., Arsenicum alb., Baptisia, Bryonia, Carbo veg.,Chelidonium majus, Cinchona, Colchicum, Daphne indica, Ipecac., Iris versicolor, Kali carb.,Kreosotum, Lachesis, Lycopodium, Mag. carb., Merc. viv, Nux vom., Phosphorus, Pulsatilla, Spigelia anth., Sulphur, Chamomilla, Echinacea, Iris versicolor, Ruta, Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. RANCID BEEF; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; DAPHNE ODORA BARK; IPECAC; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; WOOD CREOSOTE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SPIGELIA ANTHELMIA; SULFUR; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4439_7d22d236-4139-d16e-ca23-fdae0f713f32 55714-4439 HUMAN PRESCRIPTION DRUG Gas - Indigestion Pyrogenium, Antimon. crud., Arsenicum alb., Baptisia, Bryonia, Carbo veg.,Chelidonium majus, Cinchona, Colchicum, Daphne indica, Ipecac., Iris versicolor, Kali carb.,Kreosotum, Lachesis, Lycopodium, Mag. carb., Merc. viv, Nux vom., Phosphorus, Pulsatilla, Spigelia anth., Sulphur, Chamomilla, Echinacea, Ruta, Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. RANCID BEEF; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; DAPHNE ODORA BARK; IPECAC; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; WOOD CREOSOTE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SPIGELIA ANTHELMIA; SULFUR; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4440_ad1ee35c-b45f-d330-cec0-c89d14c1bd24 55714-4440 HUMAN PRESCRIPTION DRUG Oral Care - Gingivitis Aconitum nap., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium majus,Crotalus horridus, Gelsemium, Hepar sulph.calc., Kreosotum, Merc. viv., Myrrha, Nux vom., Phosphorus, Phytolacca, Plantago, Rhus toxicodendron, Slicea, Staphysag., Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; WOOD CREOSOTE; MERCURY; MYRRH; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4441_78a5ea44-c3e6-c43d-1ba8-43b141b9efc5 55714-4441 HUMAN PRESCRIPTION DRUG Oral Care - Gingivitis Aconitum nap., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Calendula, Chamomilla, Chelidonium majus,Crotalus horridus, Gelsemium, Hepar sulph.calc., Kreosotum, Merc. viv., Myrrha, Nux vom., Phosphorus, Phytolacca, Plantago, Rhus toxicodendron, Slicea, Staphysag., Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; WOOD CREOSOTE; MERCURY; MYRRH; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4444_70961b8f-f9ce-5d67-2fc3-c652ac085bac 55714-4444 HUMAN PRESCRIPTION DRUG Headache - Migraine Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; BLACK COHOSH; ARABICA COFFEE BEAN; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; CLAVICEPS PURPUREA SCLEROTIUM; VIPERA BERUS VENOM; APIS MELLIFERA; HYPERICUM PERFORATUM; THUJA OCCIDENTALIS LEAFY TWIG 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4445_ce552a8e-4374-10a3-c8ac-c725fa9c6fa2 55714-4445 HUMAN PRESCRIPTION DRUG Headache - Migraine Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; BLACK COHOSH; ARABICA COFFEE BEAN; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; CLAVICEPS PURPUREA SCLEROTIUM; VIPERA BERUS VENOM; APIS MELLIFERA; HYPERICUM PERFORATUM; THUJA OCCIDENTALIS LEAFY TWIG 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4446_8a1a289b-e2ec-31aa-3039-d9b8967c6660 55714-4446 HUMAN PRESCRIPTION DRUG Hemorrhoids Elaps corallinus, Aesculus hipp., Aloe, Arsenicum alb., Bryonia, Calc. fluor., Capsicum, Collinsonia, Crotalus horridus, Hamamelis, Hydrofluoricum acidum, Hypericum, Lachesis, Lycopodium, Millefolium, Naja, Nux vom., Paeonia, Plantago, Quercus glandium spiritus, Ratanhia, Vipera berus, Aesculus hipp, Echinacea, Solidago, Urtica ur., Aesculus hipp., Echinacea, Solidago, Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; HORSE CHESTNUT; ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAPSICUM; COLLINSONIA CANADENSIS ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROFLUORIC ACID; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; ACHILLEA MILLEFOLIUM; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; PLANTAGO MAJOR; QUERCUS ROBUR NUT; KRAMERIA LAPPACEA ROOT; VIPERA BERUS VENOM; HORSE CHESTNUT; ECHINACEA, UNSPECIFIED; SOLIDAGO VIRGAUREA FLOWERING TOP; URTICA URENS; HORSE CHESTNUT; ECHINACEA, UNSPECIFIED; SOLIDAGO VIRGAUREA FLOWERING TOP; URTICA URENS 35; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 8; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4447_5f9dab33-834a-6417-a20b-2fa3be13e1d2 55714-4447 HUMAN PRESCRIPTION DRUG Hemorrhoids Elaps corallinus, Aesculus hipp., Aloe, Arsenicum alb., Bryonia, Calc. fluor., Capsicum, Collinsonia, Crotalus horridus, Hamamelis, Hydrofluoricum acidum, Hypericum, Lachesis, Lycopodium, Millefolium, Naja, Nux vom., Paeonia, Plantago, Quercus glandium spiritus, Ratanhia, Vipera berus, Echinacea, Solidago, Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; HORSE CHESTNUT; ALOE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CAPSICUM; COLLINSONIA CANADENSIS ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROFLUORIC ACID; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; ACHILLEA MILLEFOLIUM; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; PLANTAGO MAJOR; QUERCUS ROBUR NUT; KRAMERIA LAPPACEA ROOT; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; SOLIDAGO VIRGAUREA FLOWERING TOP; URTICA URENS 35; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4448_5c513c5f-7684-2373-1576-8affbd383cc0 55714-4448 HUMAN PRESCRIPTION DRUG Menstrual - PMS Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga,Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia, Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; ESTRONE; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; ACHILLEA MILLEFOLIUM; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; CAPSELLA BURSA-PASTORIS; VIBURNUM OPULUS BARK; GINGER; ECHINACEA, UNSPECIFIED; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 55714-4449_2d662d2e-30a9-46c5-6b6e-9159fb909215 55714-4449 HUMAN PRESCRIPTION DRUG Menstrual - PMS Angelica sinensis radix, Arsenicum alb., Bryonia, Caulophyllum, Cimicifuga,Cinchona, Dioscorea, Folliculinum, Gelsemium, Lachesis, Lilium, Lycopodium, Millefolium, Nux vom., Pulsatilla, Sabina, Secale, Sepia, Thlaspi, Viburnum op., Zingiber, Echinacea, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; ESTRONE; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; ACHILLEA MILLEFOLIUM; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; CAPSELLA BURSA-PASTORIS; VIBURNUM OPULUS BARK; GINGER; ECHINACEA, UNSPECIFIED; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 55714-4450_edb76093-7a4f-418b-379e-d2276ced6c6e 55714-4450 HUMAN PRESCRIPTION DRUG Throat Care Aconitum nap., Apis mel., Arum dracontium, Belladonna, Bryonia, Cajuputum, Ferrum phosphoricum, Glycyrrhiza glabra, Kali bic., Lachesis, Mentha piperita, Merc. viv., Naja, Nat. carb., Nat. sulphuricum, Nitricum ac., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Spongia, Stannum met., Sticta, Thuja occ., Ulmus fulva, Verbascum, Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARISAEMA DRACONTIUM ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAJUPUT OIL; FERROSOFERRIC PHOSPHATE; GLYCYRRHIZA GLABRA; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MENTHA PIPERITA; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN; LOBARIA PULMONARIA; THUJA OCCIDENTALIS LEAFY TWIG; ULMUS RUBRA BARK; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4451_e1d0ce66-c069-0f7f-dab6-2818ed615efb 55714-4451 HUMAN PRESCRIPTION DRUG Throat Care Aconitum nap., Apis mel., Arum dracontium, Belladonna, Bryonia, Cajuputum, Ferrum phosphoricum, Glycyrrhiza glabra, Kali bic., Lachesis, Mentha piperita, Merc. viv., Naja, Nat. carb., Nat. sulphuricum, Nitricum ac., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Spongia, Stannum met., Sticta, Thuja occ., Ulmus fulva, Verbascum, Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARISAEMA DRACONTIUM ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAJUPUT OIL; FERROSOFERRIC PHOSPHATE; GLYCYRRHIZA GLABRA; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MENTHA PIPERITA; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN; LOBARIA PULMONARIA; THUJA OCCIDENTALIS LEAFY TWIG; ULMUS RUBRA BARK; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4452_46ffd1dd-d60b-108c-da5f-d09a671b0fd9 55714-4452 HUMAN PRESCRIPTION DRUG Herpes Sores Arsenicum alb., Bryonia, Cantharis, Chelidonium majus, Cistus canadensis, Conium, Croton, Dulcamara, Graphites, Kali bic., Lycopodium, Mezereum, Nux vom., Petroleum, Pulsatilla, Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur, Thuja occ., Echinacea, Hypericum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; HELIANTHEMUM CANADENSE; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SEPIA OFFICINALIS JUICE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4453_f5614f80-f94f-660d-3beb-c726cbf02426 55714-4453 HUMAN PRESCRIPTION DRUG Herpes Sores Arsenicum alb., Bryonia, Cantharis, Chelidonium majus, Cistus canadensis, Conium, Croton, Dulcamara, Graphites, Kali bic., Lycopodium, Mezereum, Nux vom., Petroleum, Pulsatilla, Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sepia, Sulphur, Thuja occ., Echinacea, Hypericum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; HELIANTHEMUM CANADENSE; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SEPIA OFFICINALIS JUICE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4456_4111fe91-80da-1c8f-2d0d-6c6522cc6870 55714-4456 HUMAN PRESCRIPTION DRUG Menopause Elaps corallinus, Agnus, Angelica sinensis radix, Arsenicum alb., Bryonia, Cantharis, Caulophyllum, Cimicifuga, Cinchona, Crotalus horridus, Damiana, Glonoinum, Helonias dioica, Ignatia, Kali carb., Lachesis, Naja, Nux vom., Phosphorus, Pulsatilla, Salix nigra, Sanguinaria, Sepia, Echinacea, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; CHASTE TREE; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; TURNERA DIFFUSA LEAFY TWIG; NITROGLYCERIN; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; ECHINACEA, UNSPECIFIED; VALERIAN 35; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4457_f56bd6cf-ce15-fd0c-445a-ef466b17f933 55714-4457 HUMAN PRESCRIPTION DRUG Menopause Elaps corallinus, Agnus, Angelica sinensis radix, Arsenicum alb., Bryonia, Cantharis, Caulophyllum, Cimicifuga, Cinchona, Crotalus horridus, Damiana, Glonoinum, Helonias dioica, Ignatia, Kali carb., Lachesis, Naja, Nux vom., Phosphorus, Pulsatilla, Salix nigra, Sanguinaria, Sepia, Echinacea, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; CHASTE TREE; ANGELICA SINENSIS ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; TURNERA DIFFUSA LEAFY TWIG; NITROGLYCERIN; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; ECHINACEA, UNSPECIFIED; VALERIAN 35; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4458_53d43265-e372-3e25-34ff-cf415a39247b 55714-4458 HUMAN PRESCRIPTION DRUG Cardiac Support Elaps corallinus, Aconitum nap., Arsenicum alb., Aur. met., Baryta carb., Benzoicum acidum, Berber. vulg., Bryonia, Calc. fluor. ,Cantharis, Ceanothus, Chelidonium majus , Chionanthus virginica, Cinchona, Convallaria, Crotalus horridus, Digitalis, Gelsemium , Glonoinum, Hydroflouricum acidum, Kali iodatum, Lachesis, Lycopus virginicus, Naja, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron , Vipera berus, Echinacea, Hypericum,Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; HYDROFLUORIC ACID; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPUS VIRGINICUS; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM; VALERIAN; CINCHONA OFFICINALIS BARK 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 55714-4460_359be9b3-5733-bb89-dedc-2a54969a367a 55714-4460 HUMAN PRESCRIPTION DRUG Nervousness - Anxiety Aconitum nap., Ambra, Anacardium orientale, Arg.nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali phos., Nux vom., Sambucus nig., Strychninum, Theridion, Valeriana, Passiflora LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ASAFETIDA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; BLACK COHOSH; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; THERIDION CURASSAVICUM; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4461_dfd192fe-6084-7bad-34de-94fb6210940a 55714-4461 HUMAN PRESCRIPTION DRUG Nervousness - Anxiety Aconitum nap., Ambra, Anacardium orientale, Arg.nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali phos., Nux vom., Sambucus nig., Strychninum, Theridion, Valeriana, Passiflora PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ASAFETIDA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; BLACK COHOSH; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; THERIDION CURASSAVICUM; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4462_73c5936e-630d-e213-ce08-2e0b5053281a 55714-4462 HUMAN PRESCRIPTION DRUG Neuro - Care Aconitum nap., Arg.nit., Arsenicum alb., Belladonna, Bryonia, Cinchona, Gelsemium, Hypericum, Ignatia, Kalmia, Lachesis, Lycopodium, Mag. phos., Mezereum, Phosphorus, Pulsatilla, Rhus toxicodendron, Stramonium, Strychninum, Verbascum, Chamomilla LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; KALMIA LATIFOLIA LEAF; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; DAPHNE MEZEREUM BARK; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; DATURA STRAMONIUM; STRYCHNINE; VERBASCUM THAPSUS; MATRICARIA RECUTITA 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 55714-4463_e9775327-c47f-8d13-2800-4b3a0a8fe26c 55714-4463 HUMAN PRESCRIPTION DRUG Neuro - Care Aconitum nap., Arg.nit., Arsenicum alb., Belladonna, Bryonia, Cinchona, Gelsemium, Hypericum, Ignatia, Kalmia, Lachesis, Lycopodium, Mag. phos., Mezereum, Phosphorus, Pulsatilla, Rhus toxicodendron, Stramonium, Strychninum, Verbascum, Chamomilla PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; KALMIA LATIFOLIA LEAF; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; DAPHNE MEZEREUM BARK; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; DATURA STRAMONIUM; STRYCHNINE; VERBASCUM THAPSUS; MATRICARIA RECUTITA 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 55714-4464_c2cbd06b-b85a-221f-7ddb-ba542dc4fb5e 55714-4464 HUMAN PRESCRIPTION DRUG Prostate Thyroidinum, Baryta carb., Berber. vulg., Bryonia, Calc. carb., Cinchona, Conium, Digitalis, Ferrum picricum, Hydrastis, Iodium, Lycopodium, Nux vom., Pareira, Pulsatilla, Sabal, Selenium, Staphysag., Thuja occ., Trifolium pratense, Echinacea, Hydrastis, Lappa, Solidago LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. THYROID, UNSPECIFIED; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; FERRIC PICRATE; GOLDENSEAL; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; CHONDRODENDRON TOMENTOSUM ROOT; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TRIFOLIUM PRATENSE FLOWER; ECHINACEA, UNSPECIFIED; GOLDENSEAL; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4465_2b075b61-ae3e-8007-9080-3cc2566c6335 55714-4465 HUMAN PRESCRIPTION DRUG Prostate Thyroidinum, Baryta carb., Berber. vulg., Bryonia, Calc. carb., Cinchona, Conium, Digitalis, Ferrum picricum, Hydrastis, Iodium, Lycopodium, Nux vom., Pareira, Pulsatilla, Sabal, Selenium, Staphysag., Thuja occ., Trifolium pratense, Echinacea, Lappa, Solidago PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. THYROID, UNSPECIFIED; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; GOLDENSEAL; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; CHONDRODENDRON TOMENTOSUM ROOT; PULSATILLA VULGARIS; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TRIFOLIUM PRATENSE FLOWER; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; FERRIC PICRATE 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 55714-4466_53836e15-5504-2180-13f0-298a35197de4 55714-4466 HUMAN PRESCRIPTION DRUG Bladder - Kidney Apis mel., Berber. vulg., Bryonia, Cantharis, Cinchona, Equisetum hyemale, Ferrum phosphoricum, Gelsemium, Juniperus com., Pareira, Phosphorus, Plantago, Pulsatilla, Sabal, Terebinthina, Uva-ursi, Echinacea, Hydrastis, Lappa, Solidago LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; EQUISETUM HYEMALE; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; JUNIPERUS COMMUNIS FRUIT; CHONDRODENDRON TOMENTOSUM ROOT; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SAW PALMETTO; TURPENTINE OIL; ARCTOSTAPHYLOS UVA-URSI LEAF; ECHINACEA, UNSPECIFIED; GOLDENSEAL; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 55714-4467_baaa4fb3-c396-36dc-babb-e254c9e03daa 55714-4467 HUMAN PRESCRIPTION DRUG Bladder - Kidney Apis mel., Berber. vulg., Bryonia, Cantharis, Cinchona, Equisetum hyemale, Ferrum phosphoricum, Gelsemium, Juniperus com., Pareira, Phosphorus, Plantago, Pulsatilla, Sabal, Terebinthina, Uva-ursi, Echinacea, Hydrastis, Lappa, Solidago PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; EQUISETUM HYEMALE; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; JUNIPERUS COMMUNIS FRUIT; CHONDRODENDRON TOMENTOSUM ROOT; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SAW PALMETTO; TURPENTINE OIL; ARCTOSTAPHYLOS UVA-URSI LEAF; ECHINACEA, UNSPECIFIED; GOLDENSEAL; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 55714-4468_236b7f55-1e7d-1bdf-e986-e6ca9084b694 55714-4468 HUMAN PRESCRIPTION DRUG Acne Cystic Acne Antimon. crud., Arsenicum alb., Aur. met., Berber. aqui., Bovista, Carbo veg., Causticum, Chelidonium majus, Dulcamara, Graphites, Hepar sulph. calc., Hydrocotyle, Kali brom., Kali iod., Ledum, Lycopodium, Nux vom., Silicea, Sulphur iod., Zinc. met., Echinacea, Juglans regia, Lappa, Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; GOLD; MAHONIA AQUIFOLIUM ROOT BARK; GIANT PUFFBALL; ACTIVATED CHARCOAL; CAUSTICUM; CHELIDONIUM MAJUS; SOLANUM DULCAMARA TOP; GRAPHITE; CALCIUM SULFIDE; CENTELLA ASIATICA; POTASSIUM BROMIDE; POTASSIUM IODIDE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE; SULFUR IODIDE; ZINC; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; ARCTIUM LAPPA ROOT; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 55714-4469_6c8ed581-8743-14dd-c7d6-c271d3bad811 55714-4469 HUMAN PRESCRIPTION DRUG Acne - Cystic Acne Antimon. crud., Arsenicum alb., Aur. met., Berber. aqui., Bovista, Carbo veg., Causticum, Chelidonium majus, Dulcamara, Graphites, Hepar sulph. calc., Hydrocotyle, Kali brom., Kali iod., Ledum, Lycopodium, Nux vom., Silicea, Sulphur iod., Zinc. met., Echinacea, Juglans regia, Lappa, Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; GOLD; MAHONIA AQUIFOLIUM ROOT BARK; GIANT PUFFBALL; ACTIVATED CHARCOAL; CAUSTICUM; CHELIDONIUM MAJUS; SOLANUM DULCAMARA TOP; GRAPHITE; CALCIUM SULFIDE; CENTELLA ASIATICA; POTASSIUM BROMIDE; POTASSIUM IODIDE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE; SULFUR IODIDE; ZINC; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT; ARCTIUM LAPPA ROOT; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 55714-4472_963bc3ba-c83c-6843-e0e1-ae5199cdc0b9 55714-4472 HUMAN PRESCRIPTION DRUG Varicose Veins - Phlebitis Elaps corallinus, Crotalus horridus, Bryonia, Calc. fluor., Carduus mar., Cholesterinum, Cinchona, Digitalis, Hamamelis, Hydrofluoricum acidum, Lachesis, Lycopodium, Naja, Pulsatilla, Vipera berus, Zinc. met., Aesculus hipp., Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; CROTALUS HORRIDUS HORRIDUS VENOM; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; SILYBUM MARIANUM SEED; CHOLESTEROL; CINCHONA OFFICINALIS BARK; DIGITALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; NAJA NAJA VENOM; PULSATILLA VULGARIS; VIPERA BERUS VENOM; ZINC; HORSE CHESTNUT; ECHINACEA, UNSPECIFIED 35; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-4473_775c0b06-dfcf-dd18-51c2-777863f97abf 55714-4473 HUMAN PRESCRIPTION DRUG Varicose Veins - Phlebitis Elaps corallinus, Crotalus horridus, Bryonia, Calc. fluor., Carduus mar., Cholesterinum, Cinchona, Digitalis, Hamamelis, Hydrofluoricum acidum, Lachesis, Lycopodium, Naja, Pulsatilla, Vipera berus, Zinc. met., Aesculus hipp., Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; CROTALUS HORRIDUS HORRIDUS VENOM; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; SILYBUM MARIANUM SEED; CHOLESTEROL; CINCHONA OFFICINALIS BARK; DIGITALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROFLUORIC ACID; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; NAJA NAJA VENOM; PULSATILLA VULGARIS; VIPERA BERUS VENOM; ZINC; HORSE CHESTNUT; ECHINACEA, UNSPECIFIED 35; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-4474_93f84fe4-eccb-3962-d2bd-4325ab216a8a 55714-4474 HUMAN PRESCRIPTION DRUG Insect Bites Pyrogenium, Apis mel., Aranea diadema, Arnica, Arsenicum alb, Azadirachta indica, Bryonia, Caladium seguinum , Calendula, Formica, Grindelia, Hypericum , Lachesis 15x, Latrodectus mactans, Ledum, Mezereum , Nux vom., Pulex irritans, Rhus toxicodendron, Tarentula cubensis, Tarentula hispana, Theridion, Thuja occ., Vespa crabro, Echinacea, Hamamelis Solidago LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. RANCID BEEF; APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; CALENDULA OFFICINALIS FLOWERING TOP; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULEX IRRITANS; TOXICODENDRON PUBESCENS LEAF; CITHARACANTHUS SPINICRUS; LYCOSA TARANTULA; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; VESPA CRABRO; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; SOLIDAGO VIRGAUREA FLOWERING TOP 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4475_6e42839b-29f0-3158-eace-f420a7cfcf29 55714-4475 HUMAN PRESCRIPTION DRUG Insect Bites Pyrogenium, Apis mel., Aranea diadema, Arnica, Arsenicum alb, Azadirachta indica, Bryonia, Caladium seguinum , Calendula, Formica, Grindelia, Hypericum , Lachesis 15x, Latrodectus mactans, Ledum, Mezereum , Nux vom., Pulex irritans, Rhus toxicodendron, Tarentula cubensis, Tarentula hispana, Theridion, Thuja occ., Vespa crabro, Echinacea, Hamamelis Solidago PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. RANCID BEEF; APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; CALENDULA OFFICINALIS FLOWERING TOP; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULEX IRRITANS; TOXICODENDRON PUBESCENS LEAF; CITHARACANTHUS SPINICRUS; LYCOSA TARANTULA; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; VESPA CRABRO; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; SOLIDAGO VIRGAUREA FLOWERING TOP 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4476_e7794125-c3d5-2c9d-01d4-152edfa91390 55714-4476 HUMAN PRESCRIPTION DRUG Poison Ivy Xerophyllum asphodeloides, Aconitum nap., Anacardium occidentale, Apis mel., Bryonia, Cantharis, Croton, Graphites, Grindelia, Mezereum, Nux vom., Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. LIQUID ORAL 20110701 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. XEROPHYLLUM ASPHODELOIDES; ACONITUM NAPELLUS; ANACARDIUM OCCIDENTALE FRUIT; APIS MELLIFERA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CROTON TIGLIUM SEED; GRAPHITE; GRINDELIA HIRSUTULA FLOWERING TOP; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; ECHINACEA, UNSPECIFIED; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS; SULFUR 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4477_dc85be41-7f90-4d68-f98b-b401d3b0c109 55714-4477 HUMAN PRESCRIPTION DRUG Poison Ivy Xerophyllum asphodeloides, Aconitum nap., Anacardium occidentale, Apis mel., Bryonia, Cantharis, Croton, Graphites, Grindelia, Mezereum, Nux vom., Ranunc. bulb., Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. PELLET ORAL 20110701 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. XEROPHYLLUM ASPHODELOIDES; ACONITUM NAPELLUS; ANACARDIUM OCCIDENTALE FRUIT; APIS MELLIFERA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CROTON TIGLIUM SEED; GRAPHITE; GRINDELIA HIRSUTULA FLOWERING TOP; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; ECHINACEA, UNSPECIFIED; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS; SULFUR 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4480_8f216336-7446-38b4-4710-a6df2a51c7fd 55714-4480 HUMAN PRESCRIPTION DRUG Sciatica Back Aconitum nap., Ammonium benzoicum, Arsenicum alb., Benzoicum acidum, Bryonia, Causticum, Cinchona, Colchicum, Gnaphalium polycephalum, Iris versicolor, Kali iod., Ledum, Lithium carb., Nux vom., Phytolacca, Rhus toxicodendron, Ruta, Sambucus nig., Strychninum, Hypericum, Urtica ur., Hypericum, Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMMONIUM BENZOATE; ARSENIC TRIOXIDE; BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; PSEUDOGNAPHALIUM OBTUSIFOLIUM; IRIS VERSICOLOR ROOT; POTASSIUM IODIDE; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; HYPERICUM PERFORATUM; URTICA URENS; HYPERICUM PERFORATUM; URTICA URENS; COLCHICUM AUTUMNALE BULB 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 3; 3; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Mood Stabilizer [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4481_78b98f9c-a0c4-8ad3-e14c-d5dce417723a 55714-4481 HUMAN PRESCRIPTION DRUG Sciatica - Back Care Aconitum nap., Ammonium benzoicum, Arsenicum alb., Benzoicum acidum, Bryonia, Causticum, Cinchona, Colchicum, Gnaphalium polycephalum, Iris versicolor, Kali iod., Ledum, Lithium carb., Nux vom., Phytolacca, Rhus toxicodendron, Ruta, Sambucus nig., Strychninum, Hypericum, Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; AMMONIUM BENZOATE; ARSENIC TRIOXIDE; BENZOIC ACID; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; PSEUDOGNAPHALIUM OBTUSIFOLIUM; IRIS VERSICOLOR ROOT; POTASSIUM IODIDE; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; HYPERICUM PERFORATUM; URTICA URENS; COLCHICUM AUTUMNALE BULB 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Mood Stabilizer [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4482_c47576d9-ad2f-787a-681a-ce21407aff17 55714-4482 HUMAN PRESCRIPTION DRUG Parasites Abrotanum, Aesculus hipp., Allium sativum, Arsenicum alb., Artemisia, Baptisia, Cina, Cuprum met., Filix mas, Granatum, Ipecac., Lachesis, Lycopodium, Merc. viv., Naphthalinum, Nat.mur., Nux vom., Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth., Terebinthina, Teucrium marum, Thymolum, Zingiber, Juglans regia LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARTEMISIA ABROTANUM FLOWERING TOP; HORSE CHESTNUT; GARLIC; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ARTEMISIA MARITIMA PRE-FLOWERING TOP; COPPER; DRYOPTERIS FILIX-MAS ROOT; PUNICA GRANATUM ROOT BARK; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; NAPHTHALENE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; KRAMERIA LAPPACEA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; SANTONIN; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TURPENTINE OIL; TEUCRIUM MARUM; THYMOL; GINGER; ENGLISH WALNUT 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 55714-4483_06fb83d9-c1b8-6a0e-013f-397c801a7095 55714-4483 HUMAN PRESCRIPTION DRUG Parasites Abrotanum, Aesculus hipp., Allium sativum, Arsenicum alb., Artemisia, Baptisia, Cina, Cuprum met., Filix mas, Granatum, Ipecac., Lachesis, Lycopodium, Merc. viv., Naphthalinum, Nat.mur., Nux vom., Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth., Terebinthina, Teucrium marum, Thymolum, Zingiber, Juglans regia PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARTEMISIA ABROTANUM FLOWERING TOP; HORSE CHESTNUT; GARLIC; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ARTEMISIA MARITIMA PRE-FLOWERING TOP; COPPER; DRYOPTERIS FILIX-MAS ROOT; PUNICA GRANATUM ROOT BARK; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; NAPHTHALENE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; KRAMERIA LAPPACEA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; SANTONIN; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TURPENTINE OIL; TEUCRIUM MARUM; THYMOL; GINGER; ENGLISH WALNUT 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 55714-4484_02727487-41ce-c0d7-610d-8d1e7d6d8e6e 55714-4484 HUMAN PRESCRIPTION DRUG Candidiasis Yeast Adrenalinum, Candida albicans Thyroidinum, Torula cerevisiae, Triticum, Ustilago maidis, Antimon. crud., Arsenicum alb., Baptisia, Berber. aqui, Bryonia Calc. phos., Cinchona, Helonias dioica, Hydrastis, Iodium, Iris versicolor, Kali carb., Lachesis , Lycopodium, Merc. viv., Nat. carb, Nat. phos., Nitricum ac., Phosphorus, Podoph. pelt., Pulsatilla, Sepia, Echinacea, Ginkgo, Juglans regia, Lappa, Thuja occ., Echinacea, Ginkgo, Juglans regia, Lappa, Thuja occ. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; CANDIDA ALBICANS; THYROID, UNSPECIFIED; SACCHAROMYCES CEREVISIAE; ELYMUS REPENS TOP; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; MAHONIA AQUIFOLIUM ROOT BARK; BRYONIA ALBA ROOT; TRIBASIC CALCIUM PHOSPHATE; CINCHONA OFFICINALIS BARK; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; IODINE; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; SODIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NITRIC ACID; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ECHINACEA, UNSPECIFIED; GINKGO; ENGLISH WALNUT; ARCTIUM LAPPA ROOT; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; GINKGO; ENGLISH WALNUT; ARCTIUM LAPPA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 20; 20; 20; 20; 20; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8; 8; 8; 8; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 55714-4485_2af876c8-4f1a-9504-7022-5f0844ba0ed0 55714-4485 HUMAN PRESCRIPTION DRUG Candidiasis - Yeast Adrenalinum, Candida albicans Thyroidinum, Torula cerevisiae, Triticum, Ustilago maidis, Antimon. crud., Arsenicum alb., Baptisia, Berber. aqui, Bryonia Calc. phos., Cinchona, Helonias dioica, Hydrastis, Iodium, Iris versicolor, Kali carb., Lachesis , Lycopodium, Merc. viv., Nat. carb, Nat. phos., Nitricum ac., Phosphorus, Podoph. pelt., Pulsatilla, Sepia, Echinacea, Ginkgo, Juglans regia, Lappa, Thuja occ. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; CANDIDA ALBICANS; THYROID, UNSPECIFIED; SACCHAROMYCES CEREVISIAE; ELYMUS REPENS ROOT; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; MAHONIA AQUIFOLIUM ROOT BARK; BRYONIA ALBA ROOT; TRIBASIC CALCIUM PHOSPHATE; CINCHONA OFFICINALIS BARK; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; IODINE; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; SODIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NITRIC ACID; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ECHINACEA, UNSPECIFIED; GINKGO; ENGLISH WALNUT; ARCTIUM LAPPA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 20; 20; 20; 20; 20; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 55714-4486_646483d3-fb37-59bd-c0f8-abdb22388ad2 55714-4486 HUMAN PRESCRIPTION DRUG Vaginitis - Feminine Care Agaricus musc., Arsenicum alb., Aur. met, Berber. aqui., Caladium seguinum, Candida albicans, Cantharis, Conium, Graphites, Helonias dioica, Hydrastis, Kali carb., Kreosotum, Lycopodium, Merc. viv., Murex purpurea, Nat. mur, Nitricum ac., Pulsatilla, Rhus toxicodendron, Sepia, Sulphur, Tarentula hispana, Thuja occ., Zinc. met., Apis mel, Hamamelis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; GOLD; MAHONIA AQUIFOLIUM ROOT BARK; DIEFFENBACHIA SEGUINE; CANDIDA ALBICANS; LYTTA VESICATORIA; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; POTASSIUM CARBONATE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; MERCURY; SODIUM CHLORIDE; NITRIC ACID; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; LYCOSA TARANTULA; THUJA OCCIDENTALIS LEAFY TWIG; ZINC; APIS MELLIFERA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4487_2c67cb15-4a93-89a8-bf3e-86a0dc0a0a08 55714-4487 HUMAN PRESCRIPTION DRUG Vaginitis - Feminine Care Agaricus musc., Arsenicum alb., Aur. met, Berber. aqui., Caladium seguinum, Candida albicans, Cantharis, Conium, Graphites, Helonias dioica, Hydrastis, Kali carb., Kreosotum, Lycopodium, Merc. viv., Murex purpurea, Nat. mur, Nitricum ac., Pulsatilla, Rhus toxicodendron, Sepia, Sulphur, Tarentula hispana, Thuja occ., Zinc. met., Apis mel, Hamamelis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; GOLD; MAHONIA AQUIFOLIUM ROOT BARK; DIEFFENBACHIA SEGUINE; CANDIDA ALBICANS; LYTTA VESICATORIA; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; POTASSIUM CARBONATE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; MERCURY; SODIUM CHLORIDE; NITRIC ACID; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; LYCOSA TARANTULA; THUJA OCCIDENTALIS LEAFY TWIG; ZINC; APIS MELLIFERA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4492_2ca8da63-7a6e-f813-44fb-21b443fe430c 55714-4492 HUMAN PRESCRIPTION DRUG Edometriosis Arsenicum alb., Bryonia, Cimicifuga, Cinchona, Conium, Hydrastis, Iodium, Lachesis, Lilium, Lycopodium, Phosphorus, Pulsatilla, Rhus toxicodendron, Sabina, Secale, Sepia, Apis mel., Hamamelis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; BLACK COHOSH; CINCHONA OFFICINALIS BARK; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; APIS MELLIFERA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CONIUM MACULATUM FLOWERING TOP 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4493_3fe1168c-268d-2f98-9798-81ce0f234b10 55714-4493 HUMAN PRESCRIPTION DRUG Edometriosis Arsenicum alb., Bryonia, Cimicifuga, Cinchona, Conium, Hydrastis, Iodium, Lachesis, Lilium, Lycopodium, Phosphorus, Pulsatilla, Rhus toxicodendron, Sabina, Secale, Sepia, Apis mel., Hamamelis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; BLACK COHOSH; CINCHONA OFFICINALIS BARK; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; APIS MELLIFERA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CONIUM MACULATUM FLOWERING TOP 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4500_a808f93b-2c12-1800-0eab-228182dbbbda 55714-4500 HUMAN PRESCRIPTION DRUG Muscle - Tendon Aconitum nap., Antimon. tart., Arg. nit., Arnica, Bryonia, Chamomilla, Chelidonium majus, Cimicifuga, Eupatorium perf., Hypericum, Nux vom., Rhus toxicodendron, Ruta, Sarcolacticum ac., Stramonium, Strychninum, Phytolacca, Symphytum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; SILVER NITRATE; ARNICA MONTANA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; BLACK COHOSH; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYPERICUM PERFORATUM; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DATURA STRAMONIUM; STRYCHNINE; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4501_8b569640-8345-6f55-fbdd-054b2b0da2f7 55714-4501 HUMAN PRESCRIPTION DRUG Muscle - Tendon Aconitum nap., Antimon. tart., Arg. nit., Arnica, Bryonia, Chamomilla, Chelidonium majus, Cimicifuga, Eupatorium perf., Hypericum, Nux vom., Rhus toxicodendron, Ruta, Sarcolacticum ac., Stramonium, Strychninum, Phytolacca, Symphytum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; SILVER NITRATE; ARNICA MONTANA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; BLACK COHOSH; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYPERICUM PERFORATUM; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DATURA STRAMONIUM; STRYCHNINE; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4502_d1c00990-2c01-d86f-bd89-6c761056cfef 55714-4502 HUMAN PRESCRIPTION DRUG Inflammation - Fever Anthracinum, Pyrogenium, Aconitum nap., Aloe, Apis mel., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chelidonium majus, Crotalus horridus, Ferrum phosphoricum, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Veratrum viride, Verbascum, Echinacea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; RANCID BEEF; ACONITUM NAPELLUS; ALOE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; FERROSOFERRIC PHOSPHATE; GAULTHERIA PROCUMBENS TOP; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED 35; 35; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4503_ecb5224c-16a8-fdfe-0d2f-ba8a997b4572 55714-4503 HUMAN PRESCRIPTION DRUG Inflammation - Fever Anthracinum, Pyrogenium, Aconitum nap., Aloe, Apis mel., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chelidonium majus, Crotalus horridus, Ferrum phosphoricum, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Veratrum viride, Verbascum, Echinacea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; RANCID BEEF; ACONITUM NAPELLUS; ALOE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; FERROSOFERRIC PHOSPHATE; GAULTHERIA PROCUMBENS TOP; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED 35; 35; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4504_4b612dec-6226-8bbc-bb57-c902bf2d69e7 55714-4504 HUMAN PRESCRIPTION DRUG Injury - Rescue Aconitum nap., Arnica, Bellis , Calendula , Echinacea, Gelsemium, Hamamelis, Hypericum , Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; GOLDENSEAL 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-4505_3d30e6a0-3f7a-9434-453e-8d4898fba03c 55714-4505 HUMAN PRESCRIPTION DRUG Injury - Rescue Aconitum nap., Arnica, Bellis , Calendula , Echinacea, Gelsemium, Hamamelis, Hypericum , Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; GOLDENSEAL 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-4506_c8a13ce2-5e25-2b64-7cf1-dcbb9ea8b3db 55714-4506 HUMAN PRESCRIPTION DRUG Breast Care - Fibrocystic Bufo rana, Apis mel., Asterias rubens, Belladonna, Bryonia, Calc. carb.,Chamomilla, Chimaphila umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias dioica, Lachesis, Merc. viv., Phellandrium aquaticum, Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BUFO BUFO CUTANEOUS GLAND; APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CHIMAPHILA UMBELLATA; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; LACHESIS MUTA VENOM; MERCURY; OENANTHE AQUATICA FRUIT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4507_c8f3058b-7272-1888-c48c-95bc212e8b31 55714-4507 HUMAN PRESCRIPTION DRUG Breast Care - Fibrocystic Bufo rana, Apis mel., Asterias rubens, Belladonna, Bryonia, Calc. carb.,Chamomilla, Chimaphila umbellata, Cinchona, Conium, Croton, Echinacea, Graphites, Helonias dioica, Lachesis, Merc. viv., Phellandrium aquaticum, Phosphorus, Phytolacca, Pulsatilla, Sanguinaria, Silicea, Hamamelis, Ruta, Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BUFO BUFO CUTANEOUS GLAND; APIS MELLIFERA; ASTERIAS RUBENS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CHIMAPHILA UMBELLATA; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; CROTON TIGLIUM SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; LACHESIS MUTA VENOM; MERCURY; OENANTHE AQUATICA FRUIT; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4508_24f89fb0-b485-42ba-f060-264f60505616 55714-4508 HUMAN PRESCRIPTION DRUG Dizziness - Vertigo Absinthium, Aconitum nap., Antimon. tart., Belladonna, Bryonia, Carbolicum acidum, Colchicum, Conium, Ferrum metallicum, Gelsemium, Glonoinum, Hyoscyamus, Ipecac., Iris versicolor, Lycopodium, Nux vom., Petroleum, Phosphorus, Sepia, Symphoricarpus racemosus, Tabacum, Theridion, Zingiber, Echinacea, Hypericum, Passiflora, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. WORMWOOD; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; PHENOL; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; HYOSCYAMUS NIGER; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SYMPHORICARPOS ALBUS FRUIT; TOBACCO LEAF; THERIDION CURASSAVICUM; GINGER; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4509_49890bd2-de92-ef17-3c9d-94733802f0ae 55714-4509 HUMAN PRESCRIPTION DRUG Dizziness - Vertigo Absinthium, Aconitum nap., Antimon. tart., Belladonna, Bryonia, Carbolicum acidum, Colchicum, Conium, Ferrum metallicum, Gelsemium, Glonoinum, Hyoscyamus, Ipecac., Iris versicolor, Lycopodium, Nux vom., Petroleum, Phosphorus, Sepia, Symphoricarpus racemosus, Tabacum, Theridion, Zingiber, Echinacea, Hypericum, Passiflora, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. WORMWOOD; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; PHENOL; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; HYOSCYAMUS NIGER; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SYMPHORICARPOS ALBUS FRUIT; TOBACCO LEAF; THERIDION CURASSAVICUM; GINGER; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 55714-4510_32ce4364-81f7-08c8-9825-24c160260e63 55714-4510 HUMAN PRESCRIPTION DRUG Digestive Care Antimon. crud., Arg. nit., Arsenicum alb., Baptisia, Bismuthum metallicum, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BISMUTH; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; IRIS VERSICOLOR ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; DAIKON; TOXICODENDRON PUBESCENS LEAF; TOBACCO LEAF; VERBASCUM THAPSUS; GINGER; ECHINACEA, UNSPECIFIED; JUGLANS REGIA FRUIT RIND, IMMATURE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 55714-4511_ab85aeec-7366-71e9-6472-2a6bd133d607 55714-4511 HUMAN PRESCRIPTION DRUG Digestive Care Antimon. crud., Arg. nit., Arsenicum alb., Baptisia, Bismuthum metallicum, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BISMUTH; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; IRIS VERSICOLOR ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; DAIKON; TOXICODENDRON PUBESCENS LEAF; TOBACCO LEAF; VERBASCUM THAPSUS; GINGER; ECHINACEA, UNSPECIFIED; JUGLANS REGIA FRUIT RIND, IMMATURE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 55714-4512_e695d8dc-739f-d34e-1afa-9d353f9ec8a0 55714-4512 HUMAN PRESCRIPTION DRUG Hypoglycemia Adrenalinum, Arg. nit.,Arsenicum alb., Bryonia, Cinchona, Graphites,Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. mur., Phosphorus, Phytolacca, Sulphur,Thyroidinum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; SILVER NITRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SULFUR; THYROID, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55714-4513_a171c4dd-5bf6-0fd7-6dab-47ccd0339610 55714-4513 HUMAN PRESCRIPTION DRUG Hypoglycemia Adrenalinum, Arg. nit.,Arsenicum alb., Bryonia, Cinchona, Graphites,Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. mur., Phosphorus, Phytolacca, Sulphur,Thyroidinum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; SILVER NITRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GRAPHITE; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SULFUR; THYROID, UNSPECIFIED 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55714-4518_47ce6506-a504-b6bc-134f-ed96e532af6e 55714-4518 HUMAN PRESCRIPTION DRUG Libido Agnus, Aralia quinquefolia, Baryta carb., Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Causticum, Chelidonium majus, Cinchona, Conium, Gaultheria procumbens, Graphites, Kali carb., Lycopodium, Nux vom., Onosmodium virginianum, Phosphorus, Sabal, Selenium, Sepia, Silicea, Staphysag., Hydrastis, Thuja occ. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CHASTE TREE; AMERICAN GINSENG; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; LYTTA VESICATORIA; CAUSTICUM; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; GAULTHERIA PROCUMBENS TOP; GRAPHITE; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM ROOT; PHOSPHORUS; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4519_6ae9677b-4a02-beee-d1c7-2a8a45bb3e28 55714-4519 HUMAN PRESCRIPTION DRUG Libido Agnus, Aralia quinquefolia, Baryta carb., Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Causticum, Chelidonium majus, Cinchona, Conium, Gaultheria procumbens, Graphites, Kali carb., Lycopodium, Nux vom., Onosmodium virginianum, Phosphorus, Sabal, Selenium, Sepia, Silicea, Staphysag., Hydrastis, Thuja occ. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CHASTE TREE; AMERICAN GINSENG; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; LYTTA VESICATORIA; CAUSTICUM; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; GAULTHERIA PROCUMBENS TOP; GRAPHITE; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM ROOT; PHOSPHORUS; SAW PALMETTO; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4520_1bfd88ef-e0ef-7e9d-3ce8-3db9d1c5836b 55714-4520 HUMAN PRESCRIPTION DRUG Menorrhagia Aletris, Apocynum, Cinchona, Cinnamomum, Conium, Helonias dioica, Lilium, Millefolium, Phosphorus, Secale, Thlaspi, Trillium pendulum, Apis mel., Hamamelis, Hydrastis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALETRIS FARINOSA ROOT; APOCYNUM CANNABINUM ROOT; CINCHONA OFFICINALIS BARK; CINNAMON; CONIUM MACULATUM FLOWERING TOP; CHAMAELIRIUM LUTEUM ROOT; LILIUM LANCIFOLIUM WHOLE FLOWERING; ACHILLEA MILLEFOLIUM; PHOSPHORUS; CLAVICEPS PURPUREA SCLEROTIUM; CAPSELLA BURSA-PASTORIS; TRILLIUM ERECTUM ROOT; APIS MELLIFERA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; GOLDENSEAL 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4521_bafa54f7-58e2-4499-46df-321ada366b7d 55714-4521 HUMAN PRESCRIPTION DRUG Menorrhagia Aletris, Apocynum, Cinchona, Cinnamomum, Conium, Helonias dioica, Lilium, Millefolium, Phosphorus, Secale, Thlaspi, Trillium pendulum, Apis mel., Hamamelis, Hydrastis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALETRIS FARINOSA ROOT; APOCYNUM CANNABINUM ROOT; CINCHONA OFFICINALIS BARK; CINNAMON; CONIUM MACULATUM FLOWERING TOP; CHAMAELIRIUM LUTEUM ROOT; LILIUM LANCIFOLIUM WHOLE FLOWERING; ACHILLEA MILLEFOLIUM; PHOSPHORUS; CLAVICEPS PURPUREA SCLEROTIUM; CAPSELLA BURSA-PASTORIS; TRILLIUM ERECTUM ROOT; APIS MELLIFERA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; GOLDENSEAL 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4528_9b569529-3b0b-568d-c042-07401519e738 55714-4528 HUMAN PRESCRIPTION DRUG Urticaria - Rashes Antimon. crud., Apis mel., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Histaminum hydrochloricum, Lycopodium, Mezereum , Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULEX IRRITANS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SULFUR; ECHINACEA, UNSPECIFIED; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4529_45be7737-ffd6-b42b-a989-26a101697b54 55714-4529 HUMAN PRESCRIPTION DRUG Urticaria - Rashes Antimon. crud., Apis mel., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Histaminum hydrochloricum, Lycopodium, Mezereum , Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULEX IRRITANS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SULFUR; ECHINACEA, UNSPECIFIED; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4530_6dd93b7b-88db-9c2b-af29-33bfd4c91a29 55714-4530 HUMAN PRESCRIPTION DRUG Gastritis - Ulcer Antimon. crud., Arg. nit., Arsenicum alb., Baptisia, Bismuthum metallicum, Bryonia, Cinchona, Colocynthis, Graphites, Hepar sulph. calc., Hydrastis, Ipecac., Kali bic., Kali carb., Lycopodium, Mag. carb. Mag. phos., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta,Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; GRAPHITE; CALCIUM SULFIDE; GOLDENSEAL; IPECAC; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; GINGER; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 55714-4531_07b513e4-38e3-49c8-d444-85752ad9d613 55714-4531 HUMAN PRESCRIPTION DRUG Gastritis - Ulcer Antimon. crud., Arg. nit., Arsenicum alb., Baptisia, Bismuthum metallicum, Bryonia, Cinchona, Colocynthis, Graphites, Hepar sulph. calc., Hydrastis, Ipecac., Kali bic., Kali carb., Lycopodium, Mag. carb. Mag. phos., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Zingiber, Chamomilla, Echinacea, Iris versicolor, Ruta,Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BISMUTH; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; GRAPHITE; CALCIUM SULFIDE; GOLDENSEAL; IPECAC; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; GINGER; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 55714-4532_bde2200e-ad1f-7422-20ff-78c6aff836cb 55714-4532 HUMAN PRESCRIPTION DRUG Warts - Moles - Skin Tags Antimon. crud., Bryonia, Calc.carb., Causticum, Dulcamara, Graphites, Lycopodium, Merc. sulph. rub., Nat. carb., Nitricum ac., Nux vom., Rhus toxicodendron, Sabina, Sepia, Silicea, Staphysag., Sulphur, Thuja occ.,Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; SOLANUM DULCAMARA TOP; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; MERCURIC SULFIDE; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; JUNIPERUS SABINA LEAFY TWIG; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TARAXACUM OFFICINALE 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4533_af04301f-424e-b8ea-810b-1569d3e1d05a 55714-4533 HUMAN PRESCRIPTION DRUG Warts - Moles - Skin Tags Antimon. crud., Bryonia, Calc.carb., Causticum, Dulcamara, Graphites, Lycopodium, Merc. sulph. rub., Nat. carb., Nitricum ac., Nux vom., Rhus toxicodendron, Sabina, Sepia, Silicea, Staphysag., Sulphur, Thuja occ.,Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; SOLANUM DULCAMARA TOP; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; MERCURIC SULFIDE; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; JUNIPERUS SABINA LEAFY TWIG; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TARAXACUM OFFICINALE 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4534_326474d5-5ba2-157c-4973-5a53dd8deddc 55714-4534 HUMAN PRESCRIPTION DRUG Incontinence Aloe, Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Bryonia, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Ignatia, Kali phos., Lycopodium, Nat. mur., Nitricum ac., Plantago, Pulsatilla, Rhus aromatica, Sabal, Secale, Sepia, Staphysag., Stramonium, Thyroidinum, Verbascum, Echinacea, Hydrastis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CAUSTICUM; EQUISETUM HYEMALE; IRON; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; NITRIC ACID; PLANTAGO MAJOR; PULSATILLA VULGARIS; RHUS AROMATICA ROOT BARK; SAW PALMETTO; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THYROID, UNSPECIFIED; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 55714-4535_5f134a6e-33a9-a70a-b9b2-b18fedd1aac7 55714-4535 HUMAN PRESCRIPTION DRUG Incontinence Aloe, Arg. nit., Arsenicum alb., Belladonna, Benzoicum acidum, Bryonia, Cantharis, Causticum, Equisetum hyemale, Ferrum metallicum, Gelsemium, Ignatia, Kali phos., Lycopodium, Nat. mur., Nitricum ac., Plantago, Pulsatilla, Rhus aromatica, Sabal, Secale, Sepia, Staphysag., Stramonium, Thyroidinum, Verbascum, Echinacea, Hydrastis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BENZOIC ACID; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CAUSTICUM; EQUISETUM HYEMALE; IRON; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; NITRIC ACID; PLANTAGO MAJOR; PULSATILLA VULGARIS; RHUS AROMATICA ROOT BARK; SAW PALMETTO; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THYROID, UNSPECIFIED; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 55714-4536_ec91015d-4811-baa8-13e0-e6ad28ecb103 55714-4536 HUMAN PRESCRIPTION DRUG Appetite - Craving Control Anacardium orientale, Antimon. crud., Arg. nit., Berber. vulg., Bryonia, Chelidonium majus, Digitalis, Graphites, Humulus, Iris versicolor, Kali carb., Lycopodium, Nat. carb. , Nat. sulphuricum, Nux vom., Pulsatilla, Rhus toxicodendron, Scutellaria lateriflora, Sepia, Stramonium, Chamomilla, Passiflora, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4537_2a8331b4-1750-5c3b-7983-67177fa0c68c 55714-4537 HUMAN PRESCRIPTION DRUG Appetite - Craving Control Anacardium orientale, Antimon. crud., Arg. nit., Berber. vulg., Bryonia, Chelidonium majus, Digitalis, Graphites, Humulus, Iris versicolor, Kali carb., Lycopodium, Nat. carb. , Nat. sulphuricum, Nux vom., Pulsatilla, Rhus toxicodendron, Scutellaria lateriflora, Sepia, Stramonium, Chamomilla, Passiflora, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4538_8553afde-ca53-f656-5b7a-2a6e6e6a1b07 55714-4538 HUMAN PRESCRIPTION DRUG Tobacco Withdrawal Arsenicum alb., Benzoicum acidum, Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Daphne indica, Ignatia, Iris versicolor, Lycopodium, Nicotinum, Nux vom., Rhus toxicodendron, Scutellaria lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DAPHNE ODORA BARK; STRYCHNOS IGNATII SEED; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; NICOTINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; TOBACCO LEAF; ECHINACEA, UNSPECIFIED; TARAXACUM OFFICINALE; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 55714-4539_fc6a6782-07d2-6831-d766-daad5d6e6d53 55714-4539 HUMAN PRESCRIPTION DRUG Tobacco Withdrawal Arsenicum alb., Benzoicum acidum, Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Daphne indica, Ignatia, Iris versicolor, Lycopodium, Nicotinum, Nux vom., Rhus toxicodendron, Scutellaria lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DAPHNE ODORA BARK; STRYCHNOS IGNATII SEED; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; NICOTINE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; TOBACCO LEAF; ECHINACEA, UNSPECIFIED; TARAXACUM OFFICINALE; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 55714-4540_16559fb3-cbb0-67fd-91aa-1862f0bfa2dd 55714-4540 HUMAN PRESCRIPTION DRUG Hyperactivity - Mental Focus Adrenalinum, Tarentula cubensis, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Cypripedium, Digitalis, Gelsemium, Humulus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Echinacea, Gingko, Hypericum, Passiflora LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; CITHARACANTHUS SPINICRUS; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MATRICARIA RECUTITA; CYPRIPEDIUM PARVIFOLUM ROOT; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HOPS; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SCUTELLARIA LATERIFLORA; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THERIDION CURASSAVICUM; ECHINACEA, UNSPECIFIED; GINKGO; HYPERICUM PERFORATUM; PASSIFLORA INCARNATA FLOWERING TOP 20; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4541_47c80df1-280e-47d6-e72c-6debd31bd812 55714-4541 HUMAN PRESCRIPTION DRUG Hyperactivity - Mental Focus Adrenalinum, Tarentula cubensis, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Chamomilla, Cypripedium, Digitalis, Gelsemium, Humulus, Ignatia, Impatiens glandulifera flos, Iodium, Lachesis, Lycopodium, Nat. mur., Nux vom., Scutellaria lateriflora, Staphysag., Stramonium, Theridion, Echinacea, Gingko, Hypericum, Passiflora PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; CITHARACANTHUS SPINICRUS; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MATRICARIA RECUTITA; CYPRIPEDIUM PARVIFOLUM ROOT; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HOPS; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SCUTELLARIA LATERIFLORA; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THERIDION CURASSAVICUM; ECHINACEA, UNSPECIFIED; GINKGO; HYPERICUM PERFORATUM; PASSIFLORA INCARNATA FLOWERING TOP 20; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4542_c6955cda-507a-4d07-3927-3d5e2564335e 55714-4542 HUMAN PRESCRIPTION DRUG Edema Elaps corallinus , Apis mel., Arsenicum alb. , Cantharis, Cinchona , Colchicum , Convallaria , Crotalus horridus , Digitalis , Juniperus com , Lachesis , Merc. viv. , Naja , Nat. carb. , Nat. sulphuricum , Rhus toxicodendron , Sambucus nig. , Strophanthus hispidus , Thuja occ. , Vipera berus , Echinacea , Lappa , Solidago , Taraxacum , Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; APIS MELLIFERA; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; THUJA OCCIDENTALIS LEAFY TWIG; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; URTICA URENS 35; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 55714-4543_348f1453-cf15-7ab3-749f-ff983025085d 55714-4543 HUMAN PRESCRIPTION DRUG Edema Elaps corallinus , Apis mel., Arsenicum alb. , Cantharis, Cinchona , Colchicum , Convallaria , Crotalus horridus , Digitalis , Juniperus com , Lachesis , Merc. viv. , Naja , Nat. carb. , Nat. sulphuricum , Rhus toxicodendron , Sambucus nig. , Strophanthus hispidus , Thuja occ. , Vipera berus , Echinacea , Lappa , Solidago , Taraxacum , Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; APIS MELLIFERA; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; THUJA OCCIDENTALIS LEAFY TWIG; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; URTICA URENS 35; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 55714-4544_d72ad106-b759-0526-9538-cc6de63cc17d 55714-4544 HUMAN PRESCRIPTION DRUG Lymphatic Drainer Asterias rubens, Aur. met.,Belladonna, Benzoicum acidum, Berber. vulg., Bryonia, Calc. carb., Cantharis, Ceanothus, Chelidonium majus Chionanthus virginica, Cinchona, Dioscorea ,Iris versicolor, Nat. carb., Nux vom., Ptelea, Carduus mar., Echinacea, Solidago, Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ASTERIAS RUBENS; GOLD; ATROPA BELLADONNA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CHIONANTHUS VIRGINICUS BARK; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; ECHINACEA, UNSPECIFIED; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4545_2a41ae1d-563d-5e45-2ae4-28b59421ca59 55714-4545 HUMAN PRESCRIPTION DRUG Lymphatic Drainer Asterias rubens, Aur. met.,Belladonna, Benzoicum acidum, Berber. vulg., Bryonia, Calc. carb., Cantharis, Ceanothus, Chelidonium majus Chionanthus virginica, Cinchona, Dioscorea ,Iris versicolor, Nat. carb., Nux vom., Ptelea, Carduus mar., Echinacea, Solidago, Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ASTERIAS RUBENS; GOLD; ATROPA BELLADONNA; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CHIONANTHUS VIRGINICUS BARK; DIOSCOREA VILLOSA TUBER; IRIS VERSICOLOR ROOT; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; SILYBUM MARIANUM SEED; ECHINACEA, UNSPECIFIED; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4548_7d1dc879-32aa-c0c9-8a70-d10ea68fb38a 55714-4548 HUMAN PRESCRIPTION DRUG intestinal Bacteria Pyrogenium, Arsenicum alb.,Baptisia, Bryonia, Cinchona, Collinsonia, Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. carb.,Nat.mur.,Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Rhus toxicodendron, Dioscorea, Echinacea, Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. RANCID BEEF; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; URTICA URENS; PODOPHYLLUM 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4549_7eb4d14a-c125-84bd-b723-39c208a83882 55714-4549 HUMAN PRESCRIPTION DRUG intestinal Bacteria Pyrogenium, Arsenicum alb.,Baptisia, Bryonia, Cinchona, Collinsonia, Iodium, Iris versicolor, Lachesis, Lycopodium, Nat. carb.,Nat.mur.,Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Rhus toxicodendron, Dioscorea, Echinacea, Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. RANCID BEEF; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; DIOSCOREA VILLOSA TUBER; ECHINACEA, UNSPECIFIED; URTICA URENS; PODOPHYLLUM 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4550_40791ac5-19ec-e2fd-1913-4daab23547d0 55714-4550 HUMAN PRESCRIPTION DRUG Bacterial Infection Anthracinum , Pyrogenium, Aconitum nap., Arnica, Arsenicum alb., Baptisia, Bryonia, Hydrastis, Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron , Echinacea , Iris versicolor, Urtica ur. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; RANCID BEEF; ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; URTICA URENS 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4551_ddb7e68c-6211-5da1-f0df-0f0841e26f37 55714-4551 HUMAN PRESCRIPTION DRUG Bacterial Infection Anthracinum , Pyrogenium, Aconitum nap., Arnica, Arsenicum alb., Baptisia, Bryonia, Hydrastis, Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron , Echinacea , Iris versicolor, Urtica ur. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; RANCID BEEF; ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; URTICA URENS 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4552_b3212ca5-a35b-8a2a-388f-cbf14ecf53a2 55714-4552 HUMAN PRESCRIPTION DRUG Exhaustion Chronic Fatigue Aconitum nap., Adrenalinum, Aralia quinquefolia, Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Cinchona, Iodium, Kali carb., Kali iod.,Lachesis,Lycopodium, Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca, alcohol LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; EPINEPHRINE; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; GINKGO; PHYTOLACCA AMERICANA ROOT; ECHINACEA, UNSPECIFIED; GINKGO; PHYTOLACCA AMERICANA ROOT 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55714-4553_3b0bdf85-f599-4bac-a98e-f4cb2b0bcfa7 55714-4553 HUMAN PRESCRIPTION DRUG Exhaustion - Chronic Fatigue Aconitum nap., Adrenalinum, Aralia quinquefolia, Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Cinchona, Iodium, Kali carb., Kali iod., Lachesis, Lycopodium, Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; EPINEPHRINE; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; GINKGO; PHYTOLACCA AMERICANA ROOT 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55714-4554_d3741ef3-2b18-2815-94a8-853f7aa3a8e6 55714-4554 HUMAN PRESCRIPTION DRUG Viral Infection Influenza A Virus, Influenza B Virus, Morbillinum, Aconitum nap., Antimon. tart., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc.viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Trifolium pratense, Echinacea, Hydrastis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; GAULTHERIA PROCUMBENS TOP; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; ECHINACEA, UNSPECIFIED; GOLDENSEAL 30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-4555_1a9d218a-6f2e-feeb-fa98-dfdd0fae9037 55714-4555 HUMAN PRESCRIPTION DRUG Viral Infection Influenza A Virus, Influenza B Virus, Morbillinum, Aconitum nap., Antimon. tart., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc.viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Trifolium pratense, Echinacea, Hydrastis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; GAULTHERIA PROCUMBENS TOP; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; TRIFOLIUM PRATENSE FLOWER; ECHINACEA, UNSPECIFIED; GOLDENSEAL 30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-4560_494dd01a-866d-06b3-e868-52b240e51a62 55714-4560 HUMAN PRESCRIPTION DRUG Heavy Metal Amalga Detox Allium sat, Alumin met, Arg. met., Aur. met., Baryta carb., Beryllium, Bismuthum met, Cadmium met,Calc. fluor., Carbo veg., Chelidonium maj, Cinchona, Cobaltum met., Cuprum met., Glycyrrhiza, Hydrofluoricum ac, Iris ver, Mang met, Merc. viv., Niccolum met, Osmium met, Platinum met., Plumb. met., Stannum met., Strontium carb., Thallium met, Titanium met, Carduus mar., Iris versicolor, Tarax, Carduus mar. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. GARLIC; ALUMINUM; SILVER; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; CADMIUM; CALCIUM FLUORIDE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; COBALT; COPPER; GLYCYRRHIZA GLABRA; HYDROFLUORIC ACID; IRIS VERSICOLOR ROOT; MANGANESE; MERCURY; NICKEL; OSMIUM; PLATINUM; LEAD; TIN; STRONTIUM CARBONATE; THALLIUM; TITANIUM; SILYBUM MARIANUM SEED; IRIS VERSICOLOR ROOT; TARAXACUM OFFICINALE; SILYBUM MARIANUM SEED; IRIS VERSICOLOR ROOT; TARAXACUM OFFICINALE 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 55714-4561_5ae84d1d-d38f-4150-5601-8165ff09bd83 55714-4561 HUMAN PRESCRIPTION DRUG Heavy Metal - Amalga Detox Allium sat., Alumin met., Arg. met., Aur. met., Baryta carb., Beryllium, Bismuthum met., Cadmium met., Calc. fluor., Carbo veg., Chelidonium maj., Cinchona, Cobaltum met., Cuprum met., Glycyrrhiza, Hydrofluoricum ac., Iris versicolor, Mang met., Merc. viv., Niccolum met., Osmium met., Platinum met., Plumb. met., Stannum met., Strontium carb., Thallium met., Titanium met., Carduus mar., Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. GARLIC; ALUMINUM; SILVER; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; CADMIUM; CALCIUM FLUORIDE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; COBALT; COPPER; GLYCYRRHIZA GLABRA; HYDROFLUORIC ACID; IRIS VERSICOLOR ROOT; MANGANESE; MERCURY; NICKEL; OSMIUM; PLATINUM; LEAD; TIN; STRONTIUM CARBONATE; THALLIUM; TITANIUM; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 55714-4564_221460f9-ebbb-19cb-724f-b1fa30ff7fd9 55714-4564 HUMAN PRESCRIPTION DRUG Connective Tissue Arsenicum alb., Baptisia, Berber. aqui., Calc. fluor., Capsicum, Cinchona, Iodium, Kali carb., Lachesis, Mag. carb., Merc.viv., Nat. carb., Nat. mur., Natrum sulphuricum, Phosphorus, Phytolacca, Secale, Thymus serpyllum, Thuja occ., Thyroidinum, Verbascum, Carduus mar., Echinacea, Solidago, Taraxacum LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MAHONIA AQUIFOLIUM ROOT BARK; CALCIUM FLUORIDE; CAPSICUM; IODINE; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; MAGNESIUM CARBONATE; MERCURY; SODIUM CARBONATE; SODIUM CHLORIDE; SODIUM SULFATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; CLAVICEPS PURPUREA SCLEROTIUM; THUJA OCCIDENTALIS LEAFY TWIG; THYMUS SERPYLLUM; THYROID, UNSPECIFIED; VERBASCUM THAPSUS; SILYBUM MARIANUM SEED; ECHINACEA, UNSPECIFIED; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; CINCHONA BARK 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 55714-4565_a54f462f-ee7c-c126-1846-473e96098cef 55714-4565 HUMAN PRESCRIPTION DRUG Connective Tissue Arsenicum alb., Baptisia, Berber. aqui., Calc. fluor., Capsicum, Cinchona, Iodium, Kali carb., Lachesis, Mag. carb., Merc.viv., Nat. carb., Nat. mur., Natrum sulphuricum, Phosphorus, Phytolacca, Secale, Thymus serpyllum, Thuja occ., Thyroidinum, Verbascum, Carduus mar., Echinacea, Solidago, Taraxacum PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MAHONIA AQUIFOLIUM ROOT BARK; CALCIUM FLUORIDE; CAPSICUM; IODINE; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; MAGNESIUM CARBONATE; MERCURY; SODIUM CARBONATE; SODIUM CHLORIDE; SODIUM SULFATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; CLAVICEPS PURPUREA SCLEROTIUM; THUJA OCCIDENTALIS LEAFY TWIG; THYMUS SERPYLLUM; THYROID, UNSPECIFIED; VERBASCUM THAPSUS; SILYBUM MARIANUM SEED; ECHINACEA, UNSPECIFIED; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; CINCHONA BARK 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 55714-4568_de6fec33-9c43-d6e0-d785-aa432be93ea9 55714-4568 HUMAN PRESCRIPTION DRUG Food Allergy - Additive E102 Tartrazine, E104 Quinoline yellow, E110 Sunset/Orange yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal red A, E127 Erythrosine, D128 Red 2G, E 132 Indigotine, E141 Copper/Chlorophyll Complex, E142 Green S, E211 Sodium benzoate, E212 Potassium benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium metabisulphate, E231 Orthophenylphenol, E250 Sodium nitrate, E300 Ascorbic acid, E399 Sodium mono/bi/triphosphate, E951 Aspartame, Monosodium glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EGG; FD&C YELLOW NO. 5; D&C YELLOW NO. 10; FD&C YELLOW NO. 6; CARMOISINE; AMARANTH; PONCEAU 4R; FD&C RED NO. 3; ACID RED 1; FD&C BLUE NO. 2; SODIUM COPPER CHLOROPHYLLIN; ACID GREEN 50; SODIUM BENZOATE; POTASSIUM BENZOATE; PROPYLPARABEN; SODIUM DITHIONATE; 2-PHENYLPHENOL; SODIUM NITRITE; ASCORBIC ACID; SODIUM TRIPOLYPHOSPHATE; ASPARTAME; MONOSODIUM GLUTAMATE; BEEF; PORK; LAMB; CHICKEN; TURKEY; QUAHOG, UNSPECIFIED; CRAB LEG, UNSPECIFIED; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; SCALLOP, UNSPECIFIED; AMANITA MUSCARIA FRUITING BODY; ONION; GARLIC; ANACARDIUM OCCIDENTALE FRUIT; LYCOPERDON UTRIFORME FRUITING BODY; CAFFEINE; CAPSICUM; CINNAMON; CYNARA SCOLYMUS LEAF; ALPINE STRAWBERRY; ABRUS PRECATORIUS SEED; GLYCYRRHIZA GLABRA; MENTHA PIPERITA; NUTMEG; LACTOSE; SUCROSE; BLACK MUSTARD SEED; SOLANUM NIGRUM WHOLE; ALLYLTHIOUREA; USTILAGO MAYDIS; GINGER; BRAZIL NUT; HAZELNUT, UNSPECIFIED; PEANUT; TROUT, UNSPECIFIED; COD, UNSPECIFIED; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; SOLANUM LYCOPERSICUM; SACCHARIN; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; URTICA URENS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] N 20181231 55714-4569_9613f5be-7d54-783a-e97a-279bde8c1cb9 55714-4569 HUMAN PRESCRIPTION DRUG Food Allergy - Additive E102 Tartrazine, E104 Quinoline yellow, E110 Sunset/Orange yellow, E122 Carmoisine, E123 Armaranth, E124 Cochineal red A, E127 Erythrosine, D128 Red 2G, E 132 Indigotine, E141 Copper/Chlorophyll Complex, E142 Green S, E211 Sodium benzoate, E212 Potassium benzoate, E216 Propyl P-hydroxybenzoate, E223 Sodium metabisulphate, E231 Orthophenylphenol, E250 Sodium nitrate, E300 Ascorbic acid, E399 Sodium mono/bi/triphosphate, E951 Aspartame, Monosodium glutamate, Beef, Pork, Lamb, Chicken, Turkey, Clam PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EGG; FD&C YELLOW NO. 5; D&C YELLOW NO. 10; FD&C YELLOW NO. 6; CARMOISINE; AMARANTH; PONCEAU 4R; FD&C RED NO. 3; ACID RED 1; FD&C BLUE NO. 2; SODIUM COPPER CHLOROPHYLLIN; ACID GREEN 50; SODIUM BENZOATE; POTASSIUM BENZOATE; PROPYLPARABEN; SODIUM DITHIONATE; 2-PHENYLPHENOL; SODIUM NITRITE; ASCORBIC ACID; SODIUM TRIPOLYPHOSPHATE; ASPARTAME; MONOSODIUM GLUTAMATE; BEEF; PORK; LAMB; CHICKEN; TURKEY; QUAHOG, UNSPECIFIED; CRAB LEG, UNSPECIFIED; OYSTER, UNSPECIFIED; SHRIMP, UNSPECIFIED; SCALLOP, UNSPECIFIED; AMANITA MUSCARIA FRUITING BODY; ONION; GARLIC; ANACARDIUM OCCIDENTALE FRUIT; LYCOPERDON UTRIFORME FRUITING BODY; CAFFEINE; CAPSICUM; CINNAMON; CYNARA SCOLYMUS LEAF; ALPINE STRAWBERRY; ABRUS PRECATORIUS SEED; GLYCYRRHIZA GLABRA; MENTHA PIPERITA; NUTMEG; LACTOSE; BLACK MUSTARD SEED; SOLANUM NIGRUM WHOLE; ALLYLTHIOUREA; USTILAGO MAYDIS; GINGER; BRAZIL NUT; HAZELNUT, UNSPECIFIED; PEANUT; TROUT, UNSPECIFIED; COD, UNSPECIFIED; TUNA, UNSPECIFIED; SALMON, UNSPECIFIED; HERRING, UNSPECIFIED; HISTAMINE DIHYDROCHLORIDE; SOLANUM LYCOPERSICUM; SACCHARIN; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR; URTICA URENS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 55714-4570_1f3473d1-e91d-5370-3a31-5319b94bc669 55714-4570 HUMAN PRESCRIPTION DRUG Pollen Weeds Xerophyllum asphodeloides, Adrenalinum, Alfalfa, Aletris farinosa, Artemisia vulgaris, Bellis perennis, Dysphania ambrosioides, Lycopus virginicus, Phytolacca american root, Populus tremuloides, Ptelea trifoliata, Sambusus nigra, Trillium erectum root, Elymus repens root, Urtica urens, Wyethia helenioides, Yucca filamentosa, Avena sativa pollen, Cynosurus cristatus pollen. Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. XEROPHYLLUM ASPHODELOIDES; EPINEPHRINE; ALFALFA; ALETRIS FARINOSA ROOT; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; DYSPHANIA AMBROSIOIDES; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PTELEA TRIFOLIATA BARK; SAMBUCUS NIGRA FLOWERING TOP; TRILLIUM ERECTUM ROOT; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; YUCCA FILAMENTOSA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POPULUS BALSAMIFERA LEAF BUD; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; USTILAGO MAYDIS; ONION; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; DIOSCOREA VILLOSA TUBER; GINKGO; GOLDENSEAL; TARAXACUM OFFICINALE; ANTHOXANTHUM ODORATUM POLLEN 35; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8; 8; 8; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] N 20181231 55714-4571_c2e35333-a63f-486a-5b66-04b39719b7e6 55714-4571 HUMAN PRESCRIPTION DRUG Pollen - Weeds Xerophyllum asphodeloides, Adrenalinum, Alfalfa, Aletris farinosa, Artemisia vulgaris, Bellis perennis, Dysphania ambrosioides, Lycopus virginicus, Phytolacca american root, Populus tremuloides, Ptelea trifoliata, Sambusus nigra, Trillium erectum root, Elymus repens root, Urtica urens, Wyethia helenioides, Yucca filamentosa, Avena sativa pollen, Cynosurus cristatus pollen. Echinochloa crus-galli pollen, Poa pratensis pollen, Anthoxanthum odoratum pollen, Agrostis gigantea pollen, Bromus secalinus pollen PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. XEROPHYLLUM ASPHODELOIDES; EPINEPHRINE; ALFALFA; ALETRIS FARINOSA ROOT; ARTEMISIA VULGARIS ROOT; BELLIS PERENNIS; DYSPHANIA AMBROSIOIDES; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; POPULUS TREMULOIDES LEAF; POPULUS TREMULOIDES BARK; PTELEA TRIFOLIATA BARK; SAMBUCUS NIGRA FLOWERING TOP; TRILLIUM ERECTUM ROOT; ELYMUS REPENS ROOT; URTICA URENS; WYETHIA HELENIOIDES ROOT; YUCCA FILAMENTOSA; AVENA SATIVA POLLEN; CYNOSURUS CRISTATUS POLLEN; ECHINOCHLOA CRUS-GALLI POLLEN; POA PRATENSIS POLLEN; AGROSTIS GIGANTEA POLLEN; BROMUS SECALINUS POLLEN; ALOPECURUS PRATENSIS POLLEN; PHLEUM PRATENSE POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; FAGUS SYLVATICA POLLEN; BETULA PENDULA POLLEN; QUERCUS ALBA POLLEN; FRAXINUS EXCELSIOR POLLEN; CORYLUS AMERICANA POLLEN; POPULUS NIGRA POLLEN; PLATANUS ORIENTALIS POLLEN; ULMUS GLABRA POLLEN; SALIX ALBA POLLEN; NARCISSUS PSEUDONARCISSUS; ROSA CANINA FLOWER; LILIUM CANDIDUM FLOWER; PRIMULA VULGARIS; DIANTHUS CARYOPHYLLUS FLOWER; ULEX EUROPAEUS FLOWER; CYTISUS SCOPARIUS POLLEN; CALLUNA VULGARIS POLLEN; CRATAEGUS MONOGYNA POLLEN; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POPULUS BALSAMIFERA LEAF BUD; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; USTILAGO MAYDIS; ONION; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; DIOSCOREA VILLOSA TUBER; GINKGO; GOLDENSEAL; TARAXACUM OFFICINALE; ANTHOXANTHUM ODORATUM POLLEN 35; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8; 8; 8; 20 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient] N 20181231 55714-4572_d91ed19d-70e9-8c6c-75de-21bacde569a2 55714-4572 HUMAN PRESCRIPTION DRUG Dairy - Grain - Nightshades Cow milk, Skim milk, Cow milk fat, Casein lactococcus lactis cultured aged, Casein lactococcus lactis cultured penicilium roqueforti cultured aged, Casein lctococcus lactis cultured penicillium camemberti cultured aged, Barley, Corn, Wheat gluten, Oat, White rice, Rye, Wheat, Lycopersicum esculentum, Sac. lac., Solanum tuberosum,Torula cerevisiae, Ustilago maidis, Antimon. crud., Arg.nit., Arsenicum alb., Baptisia, Bryonia, Carduus benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. COW MILK; SKIM MILK; COW MILK FAT; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; BARLEY; CORN; WHEAT GLUTEN; OAT; WHITE RICE; RYE; WHEAT; ATROPA BELLADONNA; CAPSICUM; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; SOLANUM NIGRUM WHOLE; DATURA STRAMONIUM; TOBACCO LEAF; SOLANUM LYCOPERSICUM; LACTOSE; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; ELYMUS REPENS ROOT; VERBASCUM THAPSUS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 55714-4573_7f1b97d3-dd09-3acc-51fc-60388e71dd1d 55714-4573 HUMAN PRESCRIPTION DRUG Dairy - Grain - Nightshades Cow milk, Skim milk, Cow milk fat, Casein lactococcus lactis cultured aged, Casein lactococcus lactis cultured penicilium roqueforti cultured aged, Casein lctococcus lactis cultured penicillium camemberti cultured aged, Barley, Corn, Wheat gluten, Oat, White rice, Rye, Wheat, Lycopersicum esculentum, Sac. lac., Solanum tuberosum,Torula cerevisiae, Ustilago maidis, Antimon. crud., Arg.nit., Arsenicum alb., Baptisia, Bryonia, Carduus benedictus, Cinchona, Gelsemium, Ipecac., Lachesis, Lycopodium PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. COW MILK; SKIM MILK; COW MILK FAT; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; BARLEY; CORN; WHEAT GLUTEN; OAT; WHITE RICE; RYE; WHEAT; ATROPA BELLADONNA; CAPSICUM; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; SOLANUM NIGRUM WHOLE; DATURA STRAMONIUM; TOBACCO LEAF; SOLANUM LYCOPERSICUM; LACTOSE; SOLANUM TUBEROSUM; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; ELYMUS REPENS ROOT; VERBASCUM THAPSUS; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 60; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 55714-4574_066c311c-9bba-f0c1-3005-7e1e2d4d2f14 55714-4574 HUMAN PRESCRIPTION DRUG Dust - Mold - Dander Felis catus skin, Canis lupus familiaris skin, Ortcyolagus cuniculus skin, Equus caballus skin, Serinus canaria feather, Gallus gallus feather, Anas platyrhynchos feather, Anser anser feather, Melopsittacus undulatus feather, Phasianus colchicus feather, Meleagris gallopavo feather, Felis catus hair, Human dander, Canis lupus familiaris hair, Equus caballus hair, Oryctolagus cuniculus hair, Human hair, Human skin, Sheep wool, Bos taurus hair, Capra hircus hair, Cavia porcellus hair LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. FELIS CATUS SKIN; CANIS LUPUS FAMILIARIS SKIN; ORYCTOLAGUS CUNICULUS SKIN; EQUUS CABALLUS SKIN; SERINUS CANARIA FEATHER; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; MELOPSITTACUS UNDULATUS FEATHER; PHASIANUS COLCHICUS FEATHER; MELEAGRIS GALLOPAVO FEATHER; FELIS CATUS HAIR; HUMAN DANDER; CANIS LUPUS FAMILIARIS HAIR; EQUUS CABALLUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; HUMAN HAIR; HUMAN SKIN; SHEEP WOOL; BOS TAURUS HAIR; CAPRA HIRCUS HAIR; CAVIA PORCELLUS HAIR; MESOCRICETUS AURATUS HAIR; WHEAT GLUTEN; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM HERBARUM; HOUSE DUST; CANDIDA ALBICANS; HISTAMINE DIHYDROCHLORIDE; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BLATTA ORIENTALIS; BROMINE; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 20; 20; 20; 20; 20; 20; 20; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient] N 20181231 55714-4575_fa83de7c-ae1a-ec32-e7c2-9acdde70ac7e 55714-4575 HUMAN PRESCRIPTION DRUG Dust - Mold - Dander Felis catus skin, Canis lupus familiaris skin, Ortcyolagus cuniculus skin, Equus caballus skin, Serinus canaria feather, Gallus gallus feather, Anas platyrhynchos feather, Anser anser feather, Melopsittacus undulatus feather, Phasianus colchicus feather, Meleagris gallopavo feather, Felis catus hair, Human dander, Canis lupus familiaris hair, Equus caballus hair, Oryctolagus cuniculus hair, Human hair, Human skin, Sheep wool, Bos taurus hair, Capra hircus hair, Cavia porcellus hair PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. FELIS CATUS SKIN; CANIS LUPUS FAMILIARIS SKIN; ORYCTOLAGUS CUNICULUS SKIN; EQUUS CABALLUS SKIN; SERINUS CANARIA FEATHER; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; MELOPSITTACUS UNDULATUS FEATHER; PHASIANUS COLCHICUS FEATHER; MELEAGRIS GALLOPAVO FEATHER; FELIS CATUS HAIR; HUMAN DANDER; CANIS LUPUS FAMILIARIS HAIR; EQUUS CABALLUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; HUMAN HAIR; HUMAN SKIN; SHEEP WOOL; BOS TAURUS HAIR; CAPRA HIRCUS HAIR; CAVIA PORCELLUS HAIR; MESOCRICETUS AURATUS HAIR; WHEAT GLUTEN; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM HERBARUM; HOUSE DUST; CANDIDA ALBICANS; HISTAMINE DIHYDROCHLORIDE; SACCHAROMYCES CEREVISIAE; USTILAGO MAYDIS; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BLATTA ORIENTALIS; BROMINE; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; IRIS VERSICOLOR ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 65; 20; 20; 20; 20; 20; 20; 20; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient] N 20181231 55714-4580_de802f71-3f9a-deab-91dc-a5d2709721b7 55714-4580 HUMAN PRESCRIPTION DRUG Glaucoma Aconitum nap., Aur. met., Belladonna, Causticum, Cinchona, Colchicum, Euphrasia, Gelsemium, Nux vom., Osmium metallicum, Phosphorus, Physostigma, Rhus toxicodendron, Spigelia anth. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; GOLD; ATROPA BELLADONNA; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; OSMIUM; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; TOXICODENDRON PUBESCENS LEAF; SPIGELIA ANTHELMIA 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4581_f9b9f588-fd69-3ec2-1fd1-991ce8039491 55714-4581 HUMAN PRESCRIPTION DRUG Glaucoma Aconitum nap., Aur. met., Belladonna, Causticum, Cinchona, Colchicum, Euphrasia, Gelsemium, Nux vom., Osmium metallicum, Phosphorus, Physostigma, Rhus toxicodendron, Spigelia anth. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; GOLD; ATROPA BELLADONNA; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; OSMIUM; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; TOXICODENDRON PUBESCENS LEAF; SPIGELIA ANTHELMIA 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4584_e8b54edb-86d5-b2a1-0884-0f4d99e7c270 55714-4584 HUMAN PRESCRIPTION DRUG Tinnitus Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac, Tabacum, Thiosinaminum, Viola odorata LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; DYSPHANIA AMBROSIOIDES; QUININE SULFATE; CINCHONA OFFICINALIS BARK; NITROGLYCERIN; GRAPHITE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; SALICYLIC ACID; TOBACCO LEAF; ALLYLTHIOUREA; VIOLA ODORATA 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Antimalarial [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 55714-4585_2c8847e3-e129-6b7d-ff3e-832fd636f527 55714-4585 HUMAN PRESCRIPTION DRUG Tinnitus Aconitum nap., Baryta carb., Baryta mur., Capsicum, Causticum, Chenopodium anthelminticum, Chininum sulphuricum, Cinchona, Glonoinum, Graphites, Hydrastis, Kali bic., Kali mur., Lycopodium, Phosphorus, Pulsatilla, Salicylicum ac, Tabacum, Thiosinaminum, Viola odorata PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CAPSICUM; CAUSTICUM; DYSPHANIA AMBROSIOIDES; QUININE SULFATE; CINCHONA OFFICINALIS BARK; NITROGLYCERIN; GRAPHITE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; SALICYLIC ACID; TOBACCO LEAF; ALLYLTHIOUREA; VIOLA ODORATA 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Antimalarial [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 55714-4588_000950e6-1774-b77d-e8c2-bd12a396e544 55714-4588 HUMAN PRESCRIPTION DRUG Cataracts Arsenicum alb., Bryonia, Calc. fluor., Calendula, Causticum, Conium , Euphrasia, Hydrofluoricum acidum , Iodium, Ledum, Naphthalinum, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Sepia, Silicea, Tellurium metallicum, Thiosinaminum, Zinc. met., Euphrasia LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; HYDROFLUORIC ACID; IODINE; LEDUM PALUSTRE TWIG; NAPHTHALENE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TELLURIUM; ALLYLTHIOUREA; ZINC; EUPHRASIA STRICTA 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4589_99277d8a-196f-3b89-7274-d5f64fcbe93b 55714-4589 HUMAN PRESCRIPTION DRUG Cataracts Arsenicum alb., Bryonia, Calc. fluor., Calendula, Causticum, Conium , Euphrasia, Hydrofluoricum acidum, Iodium, Ledum, Naphthalinum, Nat. mur., Nux vom., Phosphorus, Pulsatilla, Sepia, Silicea, Tellurium metallicum, Thiosinaminum, Zinc. met. PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; HYDROFLUORIC ACID; IODINE; LEDUM PALUSTRE TWIG; NAPHTHALENE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TELLURIUM; ALLYLTHIOUREA; ZINC 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4592_659200cf-e603-f19a-de8e-509929ececee 55714-4592 HUMAN PRESCRIPTION DRUG Female Fibroids Arsenicum alb., clacarea iodata, Carbo animalis, Conium, Graphites, Hydrastis, Iodium, Kreosotum, Lachesis, Phosphorus, Sabina, Secale, Sepia, Silicea, Thlaspi, Thuja occ., Thyroidinum, Trillium pendulum, Ustilago maidis LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; CALCIUM IODIDE; CARBO ANIMALIS; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; GOLDENSEAL; IODINE; WOOD CREOSOTE; LACHESIS MUTA VENOM; PHOSPHORUS; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; CAPSELLA BURSA-PASTORIS; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRILLIUM ERECTUM ROOT; USTILAGO MAYDIS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 55714-4593_b65fde64-799e-6040-6f08-ff6f82b019a2 55714-4593 HUMAN PRESCRIPTION DRUG Female Fibroids Arsenicum alb., clacarea iodata, Carbo animalis, Conium, Graphites, Hydrastis, Iodium, Kreosotum, Lachesis, Phosphorus, Sabina, Secale, Sepia, Silicea, Thlaspi, Thuja occ., Thyroidinum, Trillium pendulum, Ustilago maidis PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARSENIC TRIOXIDE; CALCIUM IODIDE; CARBO ANIMALIS; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; GOLDENSEAL; IODINE; WOOD CREOSOTE; LACHESIS MUTA VENOM; PHOSPHORUS; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; CAPSELLA BURSA-PASTORIS; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TRILLIUM ERECTUM ROOT; USTILAGO MAYDIS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 55714-4596_20dbecf0-26a9-1ec7-28d6-d855ad3dc3ca 55714-4596 HUMAN PRESCRIPTION DRUG Eye Floaters Aloe, Carbo veg., Causticum,Chelidonium majus, Cholesterinum, Cinchona, Colchicum, Cyclamen, Gelsemium, Kali carb., Merc. viv.,Phosphorus, hysostigma, Prunus spin., Senega officinalis, Sepia, Sulphur, Tabacum, Euphrasia LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ACTIVATED CHARCOAL; CAUSTICUM; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CYCLAMEN PURPURASCENS TUBER; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM CARBONATE; MERCURY; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; PRUNUS SPINOSA FLOWER BUD; POLYGALA SENEGA ROOT; SEPIA OFFICINALIS JUICE; SULFUR; TOBACCO LEAF; EUPHRASIA STRICTA 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 55714-4597_a37fbbf9-acfb-c288-4a3e-92a020adf3fd 55714-4597 HUMAN PRESCRIPTION DRUG Eye Floaters Aloe, Carbo veg., Causticum,Chelidonium majus, Cholesterinum, Cinchona, Colchicum, Cyclamen, Gelsemium, Kali carb., Merc. viv.,Phosphorus, hysostigma, Prunus spin., Senega officinalis, Sepia, Sulphur, Tabacum, Euphrasia PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ALOE; ACTIVATED CHARCOAL; CAUSTICUM; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CYCLAMEN PURPURASCENS TUBER; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM CARBONATE; MERCURY; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; PRUNUS SPINOSA FLOWER BUD; POLYGALA SENEGA ROOT; SEPIA OFFICINALIS JUICE; SULFUR; TOBACCO LEAF; EUPHRASIA STRICTA 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 55714-4598_c98ecee8-3d53-392a-8a79-459cebd19d1e 55714-4598 HUMAN PRESCRIPTION DRUG Macular Degeneration Elaps corallinus, Aconitum nap.,Aur. met., Baryta carb., Belladonna, Crotalus horridus, Gelsemium, Hamamelis, Lachesis, Merc. viv.,Phosphorus, Picricum ac., Plumbum met., Pulsatilla,Rhus toxicodendron, Stramonium, Theridion, Euphrasia LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; ACONITUM NAPELLUS; GOLD; BARIUM CARBONATE; ATROPA BELLADONNA; CROTALUS HORRIDUS HORRIDUS VENOM; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; MERCURY; PHOSPHORUS; PICRIC ACID; LEAD; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; DATURA STRAMONIUM; THERIDION CURASSAVICUM; EUPHRASIA STRICTA 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 55714-4599_3a2e93e4-3405-038f-b134-22a5fd35dbf4 55714-4599 HUMAN PRESCRIPTION DRUG Macular Degeneration Elaps corallinus, Aconitum nap.,Aur. met., Baryta carb., Belladonna, Crotalus horridus, Gelsemium, Hamamelis, Lachesis, Merc. viv.,Phosphorus, Picricum ac., Plumbum met., Pulsatilla,Rhus toxicodendron, Stramonium, Theridion, Euphrasia PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; ACONITUM NAPELLUS; GOLD; BARIUM CARBONATE; ATROPA BELLADONNA; CROTALUS HORRIDUS HORRIDUS VENOM; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; MERCURY; PHOSPHORUS; PICRIC ACID; LEAD; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; DATURA STRAMONIUM; THERIDION CURASSAVICUM; EUPHRASIA STRICTA 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 55714-4606_0a0eb82b-be51-38af-b868-9f3e387f1263 55714-4606 HUMAN PRESCRIPTION DRUG Cell Salts Calc. fluor., Calc. phos., Calc. sulph., Ferrum phosphoricum, Kali mur., Kali phos., Kali sulph., Mag. phos., Nat. mur., Nat. phos., Nat. sulphuricum, Silicea LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SILICON DIOXIDE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55714-4607_106936bd-ed16-bed3-8b2d-02b14750c2a8 55714-4607 HUMAN PRESCRIPTION DRUG Cell Salts Calc. fluor., Calc. phos., Calc. sulph., Ferrum phosphoricum, Kali mur., Kali phos., Kali sulph., Mag. phos., Nat. mur., Nat. phos., Nat. sulphuricum, Silicea PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; SILICON DIOXIDE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 55714-4612_d062da5b-fd1c-a3a2-56b1-bad8a3c5838b 55714-4612 HUMAN PRESCRIPTION DRUG Restless Leg Mygale, Agaricus musc., Causticum, Cinchona, Conium, Cuprum met., Gelsemium, Hyoscyamus, Hypericum, Kali carb, Mag.carb, Merc. viv., Nux vom., Plumb. met., Rhus toxicodendron, Secale, Strychninum, Tarentula hispana, Valeriana, Verbascum, Zinc. met., Chamomilla, Passiflora LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AVICULARIA AVICULARIA; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; MERCURY; STRYCHNOS NUX-VOMICA SEED; LEAD; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM; STRYCHNINE; LYCOSA TARANTULA; VALERIAN; VERBASCUM THAPSUS; ZINC; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4613_a7de20a6-c9f7-0303-22e1-659794b081bb 55714-4613 HUMAN PRESCRIPTION DRUG Restless Leg Mygale, Agaricus musc., Causticum, Cinchona, Conium, Cuprum met., Gelsemium, Hyoscyamus, Hypericum, Kali carb, Mag.carb, Merc. viv., Nux vom., Plumb. met., Rhus toxicodendron, Secale, Strychninum, Tarentula hispana, Valeriana, Verbascum, Zinc. met., Chamomilla, Passiflora PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. AVICULARIA AVICULARIA; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; MERCURY; STRYCHNOS NUX-VOMICA SEED; LEAD; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM; STRYCHNINE; LYCOSA TARANTULA; VALERIAN; VERBASCUM THAPSUS; ZINC; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4618_f3047949-5e7a-5237-b6fa-2255dd2f681a 55714-4618 HUMAN PRESCRIPTION DRUG Fungal Infection Candida albicans, Sanicula, Tellurium metallicum, Torula cerevisiae, Antimon. crud., Arsenicum alb., Baryta carb., Bryonia, Calc. carb., Carbo veg., Cuprum met., Dulcamara, Graphites, Kali carb., Lachesis, Lycopodium, Mezereum, Nitricum ac., Phosphorus, Phytolacca, Sepia, Silicea, Sulphur, Sulphuricum ac., Zinc. met., Apis mel., Thuja. LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CANDIDA ALBICANS; SANICULA EUROPAEA LEAF; TELLURIUM; SACCHAROMYCES CEREVISIAE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; COPPER; SOLANUM DULCAMARA TOP; GRAPHITE; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; SULFURIC ACID; ZINC; APIS MELLIFERA; THUJA OCCIDENTALIS LEAFY TWIG 20; 20; 20; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4624_ad75f5e3-44f2-c33c-3803-28aa6cf33ff3 55714-4624 HUMAN PRESCRIPTION DRUG Prime of Life Agnus, Allium sativum, Ambra, Angelica sinensis radix , Aralia quinquefolia, Arnica , Arsenicum alb., Avena, Baptisia, Baryta carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux vom., Phosphoricum ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc.met.,Ginkgo LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4625_e8800054-6a29-d658-ba90-f45c52eb6d22 55714-4625 HUMAN PRESCRIPTION DRUG Prime of Life Agnus, Allium sativum, Ambra, Angelica sinensis radix , Aralia quinquefolia, Arnica , Arsenicum alb., Avena, Baptisia, Baryta carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux vom., Phosphoricum ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc.met.,Ginkgo PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4626_1968457a-108f-bca6-5aa5-95fdee457f2f 55714-4626 HUMAN PRESCRIPTION DRUG Panic Ease Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4627_1b6563cd-8c6e-00b8-6d10-d0d792d9c5c9 55714-4627 HUMAN PRESCRIPTION DRUG Panic Ease Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana PELLET ORAL 20110601 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4631_599bcf93-2495-7218-b15b-9b7731f2786e 55714-4631 HUMAN PRESCRIPTION DRUG Immune Waker Influenzinum, Pyrogenium, Anthracinum,Arnica, Belladonna, Cantharis, Aconitum nap., Arsenicum alb., Baptisia, Bryonia, Hepar sulph. calc., Iodium, Lachesis, Merc. viv., Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Apis mel., Echinacea, Hydrastis, Thuja occ. PLASTER ORAL 20131230 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; RANCID BEEF; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ARNICA MONTANA; ATROPA BELLADONNA; LYTTA VESICATORIA; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; MERCURY; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG; INFLUENZA B VIRUS 30; 30; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] E 20171231 55714-4634_575e0ba9-8135-34c4-a0c9-6920b838c90c 55714-4634 HUMAN PRESCRIPTION DRUG Immune Waker Influenzinum, Anthracinum, Arnica, Belladonna, Aconitum nap., Arsenicum alb., Baptisia, Bryonia, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc. viv., Nux vom., Phos., Pulsatilla, Rhus tox., Apis mel., Echinacea, Hydrastis, Thuja occ., Aaricus musc,. Allium sat., Aloe, Calc. carb., Calendula, Capiscum, Carduus mar., Salvia, Selenium, Taraxacum, Tarentula hisp., Zinc. met., Zingiber LIQUID ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG; ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; GARLIC; ALOE; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; MILK THISTLE; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAGE; SELENIUM; TARAXACUM OFFICINALE; LYCOSA TARANTULA; ZINC; GINGER; BACILLUS ANTHRACIS; INFLUENZA A VIRUS; INFLUENZA B VIRUS 8; 8; 8; 8; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 20; 35; 35 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4635_d7bea61e-c664-40ae-01ef-61d67ce788cc 55714-4635 HUMAN PRESCRIPTION DRUG Immune Waker Influenzinum, Anthracinum, Arnica, Belladonna, Aconitum nap., Arsenicum alb., Baptisia, Bryonia, Hepar sulph. calc., Iodium, Lachesis, Lycopodium, Merc. viv., Nux vom., Phos., Pulsatilla, Rhus tox., Apis mel., Echinacea, Hydrastis, Thuja occ., Aaricus musc,. Allium sat., Aloe, Calc. carb., Calendula, Capiscum, Carduus mar., Salvia, Selenium, Taraxacum, Tarentula hisp., Zinc. met., Zingiber PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG; ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; GARLIC; ALOE; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; MILK THISTLE; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAGE; SELENIUM; TARAXACUM OFFICINALE; LYCOSA TARANTULA; ZINC; GINGER; BACILLUS ANTHRACIS; INFLUENZA A VIRUS; INFLUENZA B VIRUS 8; 8; 8; 8; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 20; 35; 35 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 55714-4636_60f0f8a8-c981-5868-e053-2991aa0ad94f 55714-4636 HUMAN PRESCRIPTION DRUG Vaccination - Illness Influenzinum, Morbillinum, Pertussinum, Aconitum nap., Alumina, Antimon. tart., Arsenicum alb., Baptisia, Belladonna, Bryonia, Cinchona, Crotalus horridus, Gelsemium, Kali bic., Lachesis, Ledum, Merc. viv., Mezereum, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Silicea, Sulphur, Thuja occ., Vaccinium, Apis mel., Echinacea, Hypericum LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; INFLUENZA B VIRUS; MEASLES VIRUS; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; ACONITUM NAPELLUS; ALUMINUM OXIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; MERCURY; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; BILBERRY; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM 35; 35; 35; 35; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4637_60cb9cd7-986e-cadb-e053-2991aa0aaa9e 55714-4637 HUMAN PRESCRIPTION DRUG Vaccination - Illness Influenzinum, Morbillinum, Pertussinum, Aconitum nap., Alumina, Antimon. tart., Arsenicum alb., Baptisia, Belladonna, Bryonia, Cinchona, Crotalus horridus, Gelsemium, Kali bic., Lachesis, Ledum, Merc. viv., Mezereum, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Silicea, Sulphur, Thuja occ., Vaccinium, Apis mel., Echinacea, Hypericum PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MEASLES VIRUS; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; ACONITUM NAPELLUS; ALUMINUM OXIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CROTALUS HORRIDUS HORRIDUS VENOM; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; MERCURY; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; BILBERRY; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM; INFLUENZA A VIRUS; INFLUENZA B VIRUS 35; 35; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8; 8; 35; 35 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 55714-4638_606569a1-be2e-4000-e053-2991aa0a04f5 55714-4638 HUMAN PRESCRIPTION DRUG Multi-System Aspergillus niger, Cladosporium, Candida albicans, Thyroidinum, Ustilago maidis, Aconitum nap., Antimonium tart. Aralia quinquefolia, Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Cinchona, Echinacea, Iodium, Kali carb. Kali iod., Lachesis, Lycopodium Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Sabal LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. USTILAGO MAYDIS; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM HERBARUM; CANDIDA ALBICANS; THYROID, UNSPECIFIED 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 55714-4639_606610ab-eb20-78d6-e053-2a91aa0ad14d 55714-4639 HUMAN PRESCRIPTION DRUG Multi-System Aspergillus niger, Cladosporium, Candida albicans, Thyroidinum, Ustilago maidis, Aconitum nap., Antimonium tart. Aralia quinquefolia, Arnica, Arsenicum alb., Baptisia, Bryonia, Cantharis, Chelidonium majus, Cinchona, Echinacea, Iodium, Kali carb. Kali iod., Lachesis, Lycopodium Lycopus virginicus, Nat. mur., Nux vom., Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Sabal PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ASPERGILLUS NIGER VAR. NIGER; CLADOSPORIUM HERBARUM; CANDIDA ALBICANS; THYROID, UNSPECIFIED; USTILAGO MAYDIS; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; ECHINACEA, UNSPECIFIED; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO 15; 15; 15; 15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4640_60406857-9610-894b-e053-2a91aa0adca5 55714-4640 HUMAN PRESCRIPTION DRUG Cardiac Care Elaps corallinus, Aconitum nap., Arsenicum alb., Aur. met., Baryta carb., Benzoicum acidum, Berber. vulg., Bryonia, Calc. fluor. , Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Convallaria, Crotalus horridus, Digitalis, Gelsemium , Glonoinum, Hydroflouricum acidum, Kali iodatum, Lachesis, Lycopus virginicus, Naja, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron , Vipera berus, Echinacea, Hypericum,Valeriana LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPUS VIRGINICUS; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; MICRURUS CORALLINUS VENOM; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; HYDROFLUORIC ACID; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; TOXICODENDRON PUBESCENS LEAF; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM; VALERIAN; CINCHONA OFFICINALIS BARK 10; 10; 10; 10; 10; 10; 10; 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 55714-4641_60400f1c-5b9a-367f-e053-2a91aa0a3936 55714-4641 HUMAN PRESCRIPTION DRUG Cardiac Care Elaps corallinus, Aconitum nap., Arsenicum alb., Aur. met., Baryta carb., Benzoicum acidum, Berber. vulg., Bryonia, Calc. fluor. , Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Convallaria, Crotalus horridus, Digitalis, Gelsemium , Glonoinum, Hydroflouricum acidum, Kali iodatum, Lachesis, Lycopus virginicus, Naja, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron , Vipera berus, Echinacea, Hypericum,Valeriana PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. MICRURUS CORALLINUS VENOM; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; LYTTA VESICATORIA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; HYDROFLUORIC ACID; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPUS VIRGINICUS; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; HYPERICUM PERFORATUM; VALERIAN; CINCHONA OFFICINALIS BARK 30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 10 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 55714-4642_603f3828-0d34-3273-e053-2991aa0a0ad3 55714-4642 HUMAN PRESCRIPTION DRUG Childbirth Care Arnica, Caulophyllum, Cimicifuga, Gelsemium, Pulsatilla LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARNICA MONTANA; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-4643_603c6f3e-5d03-0746-e053-2a91aa0a579b 55714-4643 HUMAN PRESCRIPTION DRUG Childbirth Care Arnica, Caulophyllum, Cimicifuga, Gelsemium, Pulsatilla PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS; ARNICA MONTANA 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 55714-4644_605258e1-e50d-4086-e053-2a91aa0af29f 55714-4644 HUMAN PRESCRIPTION DRUG Depression - Mood - Distress Angelica sinensis, radix, Aralia quinquefolia, Arg. nit., Arsenicum alb., Berber. aqui., Capsicum, Cinchona, Digitalis, Gelsemium, Hypericum, Ignatia, Iodium, Kali brom., Kali carb., Mag. phos., Nat. carb., Nat. mur., Phosphorus, Salix nigra, Sanguinaria, Sepia, Stramonium, Echinacea, Ginkgo LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANGELICA SINENSIS ROOT; AMERICAN GINSENG; SILVER NITRATE; ARSENIC TRIOXIDE; MAHONIA AQUIFOLIUM ROOT BARK; CAPSICUM; CINCHONA OFFICINALIS BARK; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IODINE; POTASSIUM BROMIDE; POTASSIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CARBONATE; SODIUM CHLORIDE; PHOSPHORUS; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; ECHINACEA, UNSPECIFIED; GINKGO 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 55714-4645_6053bb74-b6d0-67ee-e053-2991aa0a993c 55714-4645 HUMAN PRESCRIPTION DRUG Depression - Mood - Distress Angelica sinensis, radix, Aralia quinquefolia, Arg. nit., Arsenicum alb., Berber. aqui., Capsicum, Cinchona, Digitalis, Gelsemium, Hypericum, Ignatia, Iodium, Kali brom., Kali carb., Mag. phos., Nat. carb., Nat. mur., Phosphorus, Salix nigra, Sanguinaria, Sepia, Stramonium, Echinacea, Ginkgo PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANGELICA SINENSIS ROOT; AMERICAN GINSENG; SILVER NITRATE; ARSENIC TRIOXIDE; MAHONIA AQUIFOLIUM ROOT BARK; CAPSICUM; CINCHONA OFFICINALIS BARK; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IODINE; POTASSIUM BROMIDE; POTASSIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CARBONATE; SODIUM CHLORIDE; PHOSPHORUS; SALIX NIGRA BARK; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; ECHINACEA, UNSPECIFIED; GINKGO 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 55714-4647_60689b96-cb5b-925a-e053-2a91aa0a32a3 55714-4647 HUMAN PRESCRIPTION DRUG Thyroid Care Adrenalinum, Thyroidinum, Aloe, Calc. carb., Chelidonium majus, Conium, Graphites, Iodium, Lachesis, Lycopodium, Lycopus virginicus, Phytolacca, Rhus toxicodendron, Silicea, Spongia, Echinacea LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; THYROID, UNSPECIFIED; ALOE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; ECHINACEA, UNSPECIFIED; IODINE 20; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55714-4648_60a4e737-d057-a417-e053-2a91aa0a3455 55714-4648 HUMAN PRESCRIPTION DRUG Thyroid Care Adrenalinum, Thyroidinum, Aloe, Calc. carb., Chelidonium majus, Conium, Graphites, Iodium, Lachesis, Lycopodium, Lycopus virginicus, Phytolacca, Rhus toxicodendron, Silicea, Spongia, Echinacea PELLET ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. EPINEPHRINE; THYROID, UNSPECIFIED; ALOE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; ECHINACEA, UNSPECIFIED; IODINE 20; 20; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 8; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 55714-6063_0a931929-0ea5-4d0f-e054-00144ff88e88 55714-6063 HUMAN OTC DRUG Arnica montana Arnica montana LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARNICA MONTANA 15 [hp_X]/mL N 20181231 55714-6083_ec0dda76-af8a-252f-eee8-91753ef2144e 55714-6083 HUMAN PRESCRIPTION DRUG Borrelia burgdorferi Borrelia burgdorferi LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BORRELIA BURGDORFERI 200 [hp_C]/mL N 20181231 55714-6091_e8c41007-d7a8-0523-8528-329f2ca2c36f 55714-6091 HUMAN OTC DRUG Belladonna Belladonna LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ATROPA BELLADONNA 15 [hp_X]/mL N 20181231 55714-6107_373240cd-cd31-6695-e4c5-07bb1a1e9ee7 55714-6107 HUMAN OTC DRUG Bryonia Bryonia LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BRYONIA ALBA ROOT 15 [hp_X]/mL N 20181231 55714-6117_c1a95727-dbc8-e388-1347-f18da842f144 55714-6117 HUMAN OTC DRUG Calcarea fluorica Calcarea fluorica LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CALCIUM FLUORIDE 15 [hp_X]/mL N 20181231 55714-6174_2be09477-44b9-47b9-a074-f612d894a97b 55714-6174 HUMAN OTC DRUG Convallaria majalis Convallaria majalis LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. CONVALLARIA MAJALIS 15 [hp_X]/mL N 20181231 55714-6242_6e724197-336a-9bf6-54a0-3cfdff380e01 55714-6242 HUMAN OTC DRUG Gelsemium sempervirens Gelsemium sempervirens LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]/mL N 20181231 55714-6275_4085295e-d357-0f8c-e826-0776dfb22d03 55714-6275 HUMAN OTC DRUG Hypericum perforatum Hypericum perforatum LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. HYPERICUM PERFORATUM 15 [hp_X]/mL N 20181231 55714-6283_d40d68f6-6763-50b4-deae-683607daca55 55714-6283 HUMAN OTC DRUG Iodium Iodium LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. IODINE 15 [hp_X]/mL N 20181231 55714-6297_55de6643-dc8f-aaf7-0228-3ab198b734d7 55714-6297 HUMAN OTC DRUG Kali muriaticum Kali muriaticum LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. POTASSIUM CHLORIDE 15 [hp_X]/mL N 20181231 55714-6306_2e6c1ec2-cbff-b6d1-8840-69b6f0263432 55714-6306 HUMAN OTC DRUG Lachesis mutus Lachesis mutus LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. LACHESIS MUTA VENOM 15 [hp_X]/mL N 20181231 55714-6387_73e42b76-609e-edfe-777b-cd5fe4161149 55714-6387 HUMAN OTC DRUG Nux vomica Nux vomica LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/mL N 20181231 55714-6417_6cc8d34c-c5d9-deb5-22eb-d53b6fe1ec6b 55714-6417 HUMAN OTC DRUG Phosphorus Phosphorus LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. PHOSPHORUS 15 [hp_X]/mL N 20181231 55714-6453_5baa5348-4b84-6d65-5030-dfa8315f0972 55714-6453 HUMAN OTC DRUG Hypothalamus Hypothalamus LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BOS TAURUS HYPOTHALAMUS 15 [hp_X]/mL N 20181231 55714-6516_f3151f1a-7eb9-d350-f133-c7d5907b2ddc 55714-6516 HUMAN OTC DRUG Sulphur Sulphur LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. SULFUR 15 [hp_X]/mL N 20181231 55714-6540_8f19025a-7fcb-62f6-e19f-88b8b307ae17 55714-6540 HUMAN OTC DRUG Thuja occidentalis Thuja occidentalis LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X]/mL N 20181231 55714-6612_eb1ffc5c-6e02-3a0e-a35c-ba242c431663 55714-6612 HUMAN PRESCRIPTION DRUG Parathyroid Parathyroid LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. HUMAN PARATHYROID 15 [hp_X]/mL N 20181231 55714-6634_bd01837d-3c83-cf38-a697-fb208ff717cf 55714-6634 HUMAN PRESCRIPTION DRUG Progesterone Progesterone LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. PROGESTERONE 15 [hp_X]/mL Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 55714-7387_86d29360-f4a2-f1f7-f9a2-66d42d704456 55714-7387 HUMAN OTC DRUG Nux vomica Nux vomica PELLET ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/g N 20181231 55714-7540_dbdbfe9b-b84a-cf6b-3774-4f1f46c934ea 55714-7540 HUMAN OTC DRUG Thuja occidentalis Thuja occidentalis PELLET ORAL 20110901 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X]/g N 20181231 55714-8000_fd162601-1b55-1a68-6820-d9707a7fac8d 55714-8000 HUMAN OTC DRUG Detox Uricum acidum, Benzoicum acidum, Berber. vulg., Bryonia, Cantharis, Carduus benedictus, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Dioscorea, Dolichos, Iris versicolor, Juniperus com., Nux vom.,Ptelea,Taraxacum, Carduus mar., Cynara scolymus, Solidago LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. URIC ACID; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8001_4a11b0df-0228-81ff-510f-20a7d05b4fc2 55714-8001 HUMAN OTC DRUG Stress - Panic Aconitum nap., Apis mel., Arnica, Arsenicum alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus canadensis, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus spin., Rhus toxicodendron, Sarcolacticum ac., Sulphur, Veratrum alb., Valeriana LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8002_263d0205-1e8d-a697-fa3d-e190b77c1af9 55714-8002 HUMAN OTC DRUG Nausea Bismuthum metallicum, Bryonia, Cimicifuga, Gossypium herbaceum, Ipecac., Kreosotum, Lycopodium, Mag. carb., Nux vom., Pulsatilla, Sepia, Symphoricarpus racemosus, Tabacum, Zingiber, Chamomilla, Hydrastis, Iris versicolor LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; BRYONIA ALBA ROOT; BLACK COHOSH; GOSSYPIUM HERBACEUM ROOT BARK; IPECAC; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SYMPHORICARPOS ALBUS FRUIT; TOBACCO LEAF; GINGER; MATRICARIA RECUTITA; GOLDENSEAL; IRIS VERSICOLOR ROOT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8003_771b261c-4e79-62fc-e59a-7075b138e8cf 55714-8003 HUMAN OTC DRUG Bites - Stings Pyrogenium, Apis mel., Aranea diadema, Arnica, Arsenicum alb., Azadirachta indica, Bryonia, Caladium seguinum, Calendula, Formica, Grindelia, Hypericum, Lachesis, Latrodectus mactans, Ledum, Mezereum, Nux vom., Pulex irritans, Rhus toxicodendron, Tarentula cubensis, Tarentula hispana, Theridion, Thuja occ., Vespa crabro, Echinacea, Hamamelis, Solidago LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. RANCID BEEF; APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BRYONIA ALBA ROOT; DIEFFENBACHIA SEGUINE; CALENDULA OFFICINALIS FLOWERING TOP; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULEX IRRITANS; TOXICODENDRON PUBESCENS LEAF; CITHARACANTHUS SPINICRUS; LYCOSA TARANTULA; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; VESPA CRABRO; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; SOLIDAGO VIRGAUREA FLOWERING TOP 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8004_75e10547-4cb7-7867-5da9-b339676fa3c8 55714-8004 HUMAN OTC DRUG Injury Rescue Aconitum nap, Arnica, Bellis, Calendula, Echinacea, Gelsemium, Hamamelis, Hypericum, Ledum, Phosphorus, Rhus toxicodendron, Ruta, Staphysag., Symphytum, Hydrastis canadensis. LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; GOLDENSEAL 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8005_6875ba7a-d7cf-80d6-5be0-a250351a7211 55714-8005 HUMAN OTC DRUG Bowel - Digestive Care Bismuthum metallicum, Antimon.crud., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Chamomilla, Cinchona, Iris versicolor, Kali bic., Lachesis, Lycopodium, Mag. carb., Nux vom., Phosphorus, Podoph. pelt., Pulsatilla, Raphanus, Rhus toxicodendron, Tabacum, Verbascum, Zingiber, Echinacea, Juglans regia. LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BISMUTH; ANTIMONY TRISULFIDE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; IRIS VERSICOLOR ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; RADISH; TOXICODENDRON PUBESCENS LEAF; TOBACCO LEAF; VERBASCUM THAPSUS; GINGER; ECHINACEA, UNSPECIFIED; ENGLISH WALNUT 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8006_ae43f96a-4c53-d83a-ae99-c83f70586cac 55714-8006 HUMAN OTC DRUG Kidney - Bladder Apis mel., Berber. vulg., Bryonia, Cantharis, Cinchona, Equisetum hyemale, Ferrum phosphoricum, Gelsemium, Juniperus com., Pareira, Phosphorus, Plantago, Pulsatilla, Sabal, Terebinthina, Uva-ursi, Echinacea, Hydrastis, Lappa, Solidago LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; EQUISETUM HYEMALE; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; CHONDRODENDRON TOMENTOSUM ROOT; PHOSPHORUS; PLANTAGO MAJOR; PULSATILLA VULGARIS; SAW PALMETTO; TURPENTINE OIL; ARCTOSTAPHYLOS UVA-URSI LEAF; ECHINACEA, UNSPECIFIED; GOLDENSEAL; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8007_7db80e8d-bd3c-4752-eb9e-bff9e2f02226 55714-8007 HUMAN OTC DRUG Cold - Sinus Influenza A Virus, Influenza B Virus, Aralia quinquefolia, Arsenicum alb., Bryonia, Euphrasia, Gaultheria procubens, Gelsemium, Hepar sulph. calc., Histaminum hydrochloricum, Hydrastis, Kali bic., Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Sabadilla, Salvia, Sticta, Verbascum, Echinacea LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; AMERICAN GINSENG; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; GAULTHERIA PROCUMBENS TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SAGE; LOBARIA PULMONARIA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8008_de4b8961-2876-2846-5e54-03aeb253a70a 55714-8008 HUMAN OTC DRUG Pain Soother Aconitum nap., Arg. nit., Arnica, Bryonia, Colchicum, Guaiacum, Hypericum, Kalmia, Phosphorus, Phytolacca, Pulsatilla, Rhus toxicodendron, Ruta, Sarcolacticum ac., Sticta, Stramonium, Hamamelis, Taraxacum, LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; SILVER NITRATE; ARNICA MONTANA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; GUAIAC; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; LOBARIA PULMONARIA; DATURA STRAMONIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TARAXACUM OFFICINALE 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8009_5769c34d-ff42-67a2-4e09-31ea79130844 55714-8009 HUMAN OTC DRUG Fever - Infection Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Aconitum nap., Antimon. tart., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chamomilla, Cinchona, Eupatorium perf., Ferrum metallicum, Gelsemium, Hepar sulph.calc., Iodium, Lachesis, Merc. viv., Phosphorus, Pulsatilla, Rhus toxicodendron, Salix nigra, Verbascum, Apis mel., Echinacea, Hydrastis LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; IRON; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; MERCURY; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SALIX NIGRA BARK; VERBASCUM THAPSUS; APIS MELLIFERA; ECHINACEA, UNSPECIFIED; GOLDENSEAL; INFLUENZA B VIRUS 30; 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8010_e35b9109-3d1b-fe6c-fd86-569bd9247d17 55714-8010 HUMAN OTC DRUG Sick Stopper Anthracinum, Influenzinum, Pyrogenium, Bufo rana, Aconitum nap., Agaricus musc., Aralia quinquefolia, Baptisia, Bryonia, Chelidonium majus, Eupatorium perf., Hepar sulph. calc., Lachesis, Lycopodium, Nux vom., Rhus toxicodendron, Sanguinaria, Sulphur, Thuja occ., Echinacea LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS 30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8011_35068aee-7a2f-3b17-26f6-67ad537f5900 55714-8011 HUMAN OTC DRUG Parasites Abrotanum, Aesculus hipp., Allium sativum, Arsenicum alb., Artemisia, Baptisia, Cina, Cuprum met., Filix mas, Granatum, Ipecac, Lachesis, Lycopodium, Merc. viv, Naphthalinum, Nat. mur., Nux vom., Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth., Terebinthina, Teucrium marum, Thymolum, Zingiber, Juglans regia LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ARTEMISIA ABROTANUM FLOWERING TOP; HORSE CHESTNUT; GARLIC; ARSENIC TRIOXIDE; ARTEMISIA VULGARIS ROOT; BAPTISIA TINCTORIA; ARTEMISIA CINA PRE-FLOWERING TOP; COPPER; DRYOPTERIS FILIX-MAS ROOT; PUNICA GRANATUM ROOT BARK; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; NAPHTHALENE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; KRAMERIA LAPPACEA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; SANTONIN; SILICON DIOXIDE; SPIGELIA ANTHELMIA; TURPENTINE OIL; TEUCRIUM MARUM; THYMOL; GINGER; ENGLISH WALNUT 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8012_d5f4f06b-6240-90c4-45f1-0e769f3da60b 55714-8012 HUMAN OTC DRUG Inflammation Anthracinum, Pyrogenium, Aconitum nap., Aloe, Apis mel., Arnica, Arsenicum alb., Baptisia, Belladonna, Bryonia, Cantharis, Chelidonium majus, Crotalus horridus, Ferrum phosphoricum, Gaultheria procumbens, Hepar sulph. calc., Iodium, Lachesis, Nux vom., Phosphorus, Pulsatilla, Rhus toxicodendron, Veratrum viride, Verbascum, Echinacea LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; RANCID BEEF; ACONITUM NAPELLUS; ALOE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; FERROSOFERRIC PHOSPHATE; GAULTHERIA PROCUMBENS TOP; CALCIUM SULFIDE; IODINE; LACHESIS MUTA VENOM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; VERATRUM VIRIDE ROOT; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED 30; 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8013_c3978e7d-007c-5dbb-ed7a-4dd2914c9c21 55714-8013 HUMAN OTC DRUG Rashes - Hives Antimon. crud., Apis mel., Arsenicum alb., Berber. vulg., Bovista, Bryonia, Cantharis, Chelidonium majus, Croton, Dulcamara, Graphites, Histaminum hydrochloricum, Lycopodium, Mezereum, Nux vom., Petroleum, Pulex irritans, Pulsatilla, Rhus toxicodendron, Sarsaparilla, Sulphur, Echinacea, Rumex crisp., Taraxacum, Urtica ur. LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BERBERIS VULGARIS ROOT BARK; GIANT PUFFBALL; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CROTON TIGLIUM SEED; SOLANUM DULCAMARA TOP; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PULEX IRRITANS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT; SULFUR; ECHINACEA, UNSPECIFIED; RUMEX CRISPUS ROOT; TARAXACUM OFFICINALE; URTICA URENS 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8014_61febc3a-7ba9-6691-2b5b-89f1f8d10c15 55714-8014 HUMAN OTC DRUG Diarrhea Pyrogenium, Aconitum nap., Arg. nit., Arsenicum alb., Baptisia, Bryonia, Carbo veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris versicolor, Lycopodium, Podoph. pelt., Raphanus, Tabacum, Vaccinium, Zingiber, Aesculus hipp., Juglans regia LIQUID ORAL 20140415 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. RANCID BEEF; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; PODOPHYLLUM; RADISH; TOBACCO LEAF; BILBERRY; GINGER; HORSE CHESTNUT; ENGLISH WALNUT 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8016_7351145d-7651-a235-893b-e4a42afe97ee 55714-8016 HUMAN OTC DRUG Just In Case Aconitum nap., Arnica, Arsenicum alb., Bryonia, Echinacea, Ledum, Cenchris, Crotalus casc. Crotalus hor., Lachesis, Merc. corros., Naja, Phos., Toxicophis, Vipera, Elaps cor., Heloderma LIQUID ORAL 20141110 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; ECHINACEA, UNSPECIFIED; LEDUM PALUSTRE TWIG; AGKISTRODON CONTORTRIX VENOM; CROTALUS DURISSUS TERRIFICUS VENOM; CROTALUS HORRIDUS HORRIDUS VENOM; LACHESIS MUTA VENOM; MERCURIC CHLORIDE; NAJA NAJA VENOM; PHOSPHORUS; AGKISTRODON PISCIVORUS VENOM; VIPERA BERUS VENOM; MICRURUS CORALLINUS VENOM; HELODERMA SUSPECTUM VENOM 10; 10; 10; 10; 10; 10; 15; 15; 15; 15; 15; 15; 15; 15; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55714-8017_603b203d-a324-1459-e053-2a91aa0a3231 55714-8017 HUMAN OTC DRUG Breath Ease Influenza A Virus, Influenza B Virus, Antimon. tart., Arsenicum alb., Bryonia, Chelidonium majus, Cinchona, Drosera, Eucalyptus, Histaminum hydrochloricum, Hydrastis, Kali bic., Kali carb.,Kali iod., Myrrha, Nat. sulphuricum, Nux vom., Phosphorus, Pulsatilla, Rumex crisp., Sambucus nig., Spongia, Tussilago farfara, Verbascum, Echinacea, Lappa LIQUID ORAL 20170417 UNAPPROVED HOMEOPATHIC Newton Laboratories, Inc. INFLUENZA A VIRUS; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; DROSERA ROTUNDIFOLIA FLOWERING TOP; EUCALYPTUS GLOBULUS LEAF; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; POTASSIUM IODIDE; MYRRH; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; TUSSILAGO FARFARA; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; INFLUENZA B VIRUS 30; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55715-001_6155ed6e-f91c-8a9d-e053-2a91aa0a2bd6 55715-001 HUMAN OTC DRUG Zepol Topical Analgesic Camphor, Menthol OINTMENT TOPICAL 20091005 OTC MONOGRAPH NOT FINAL part348 Laboratorios Zepol S.A. CAMPHOR (SYNTHETIC); MENTHOL 6.55; 6.55 g/100g; g/100g N 20181231 55715-002_6195e63c-01f6-6c90-e053-2991aa0ae81a 55715-002 HUMAN OTC DRUG Manzatin-E Diaper Rash Skin Protectant Zinc Oxide OINTMENT TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part348 Laboratorios Zepol S.A. ZINC OXIDE 18 g/100g N 20191231 55722-034_954098bd-23a0-4c60-8def-57cfe75df28b 55722-034 HUMAN OTC DRUG Youngevity Invision CM Menthol CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Imagenetix MENTHOL 12.5 mg/g E 20171231 55722-419_9cdba220-6919-4ba3-b6d6-e71d63f01360 55722-419 HUMAN OTC DRUG EFAC Pain Relieving Menthol CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part348 Imagenetix MENTHOL 12.5 mg/g E 20171231 55724-211_58fc1cfc-431f-4b89-9e7a-34758e9eb087 55724-211 HUMAN PRESCRIPTION DRUG Eucrisa crisaborole OINTMENT TOPICAL 20170130 NDA NDA207695 Pfizer Laboratories Div Pfizer Inc CRISABOROLE 20 mg/g Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA] N 20181231 55726-048_d6d5c007-d475-4375-ad3b-29f4b5582363 55726-048 HUMAN OTC DRUG ZeroSweat 3 DAY PROTECTION ANTIPERSPIRANT Aluminum Chloride LIQUID TOPICAL 20120611 OTC MONOGRAPH FINAL part350 ZeroSweat Inc ALUMINUM CHLORIDE 15 mg/mL N 20181231 55726-293_015dc986-92ed-4538-89a8-726537bec209 55726-293 HUMAN OTC DRUG Antiperspirant for Hands Feet Body Zero Sweat Aluminum Sesquichlorohydrate LOTION TOPICAL 20170915 OTC MONOGRAPH FINAL part350 Zero Sweat Inc. ALUMINUM SESQUICHLOROHYDRATE 150 mg/mL N 20181231 55728-001_870c4676-be3d-4a0a-b0e1-29f337713bea 55728-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19780102 NDA NDA205737 A & B Welding Supply Co. OXYGEN 990 mL/L N 20181231 55728-002_45fd1e01-2c8d-4fcc-ac6b-0b1243256309 55728-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20120109 NDA NDA205738 A & B Welding Supply Co. NITROGEN 990 mL/L N 20181231 55739-1022_4e7ff19e-48ee-4d46-9b5f-c7ecd303d178 55739-1022 HUMAN OTC DRUG Perineze Triple Dye BRILLIANT GREEN, PROFLAVINE HEMISULFATE, GENTIAN VIOLET SOLUTION TOPICAL 20110928 OTC MONOGRAPH NOT FINAL part333E Peace Medical Inc. BRILLIANT GREEN; PROFLAVINE HEMISULFATE; GENTIAN VIOLET 2.29; 1.14; 2.29 mg/.61mL; mg/.61mL; mg/.61mL E 20171231 55741-000_14dbc2c6-06ee-dcb4-0cf9-f1d804374a56 55741-000 HUMAN OTC DRUG Bufferin Arthritis Aspirin TABLET ORAL 20160720 OTC MONOGRAPH FINAL part343 Dr. Reddy's Laboratories Inc. ASPIRIN 325 mg/1 N 20181231 55741-002_8b6fc7a3-2dd0-bbe6-ca1c-ca2ba34b4f93 55741-002 HUMAN OTC DRUG Doans Pain Relieving Lidocaine and menthol, unspecified form CREAM TOPICAL 20160524 OTC MONOGRAPH NOT FINAL part348 Dr. Reddy's Laboratories Inc. LIDOCAINE; MENTHOL, UNSPECIFIED FORM 4; 1 g/100g; g/100g N 20181231 55741-013_9f0c1dc9-2f75-65f3-b5d5-ab789b025a74 55741-013 HUMAN OTC DRUG Bufferin Aspirin TABLET ORAL 20160524 OTC MONOGRAPH FINAL part343 Dr. Reddy's Laboratories Inc. ASPIRIN 325 mg/1 N 20181231 55741-224_9f6bddea-c5b0-4f61-6c90-6934b10183bb 55741-224 HUMAN OTC DRUG Doans Extra Strength Magnesium salicylate TABLET ORAL 20160524 OTC MONOGRAPH NOT FINAL part343 Dr. Reddy's Laboratories Inc. MAGNESIUM SALICYLATE 580 mg/1 N 20181231 55741-304_f8ebb402-2426-c20c-0825-59971603ed5b 55741-304 HUMAN OTC DRUG Myoflex Trolamine salicylate CREAM TOPICAL 20160524 OTC MONOGRAPH NOT FINAL part348 Dr. Reddy's Laboratories Inc. TROLAMINE SALICYLATE 10 g/100g N 20181231 55741-402_99eecaf4-13f7-d87f-f446-be9d512c1fe3 55741-402 HUMAN OTC DRUG Nupercainal Dibucaine OINTMENT TOPICAL 20160524 OTC MONOGRAPH FINAL part346 Dr. Reddy's Laboratories Inc. DIBUCAINE 1 g/100g N 20181231 55741-412_b8b95bde-20f8-4c08-aac9-dc4a8130d673 55741-412 HUMAN OTC DRUG Nupercainal Bio-Active Hemorrhoidal Hamamelis Virginiana Root Bark/Stem Bark, Echinacea purpurea, Centella asiatica, and Sambucus Nigra Flowering Top CREAM TOPICAL 20140407 UNAPPROVED HOMEOPATHIC Ducere Pharma HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ECHINACEA PURPUREA; CENTELLA ASIATICA; SAMBUCUS NIGRA FLOWERING TOP 5; 5; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 55741-424_1216c2b7-4a5d-43a9-b5f4-eb73c900b4ad 55741-424 HUMAN OTC DRUG Nupercainal Bio-Active Hemorrhoidal Echinacea purpurea, Centella asiatica, and Sambucus nigra flowering top SUPPOSITORY RECTAL 20140407 UNAPPROVED HOMEOPATHIC Ducere Pharma ECHINACEA PURPUREA; CENTELLA ASIATICA; SAMBUCUS NIGRA FLOWERING TOP .1; .1; .1 g/1; g/1; g/1 N 20181231 55741-446_763e5560-549d-d450-5451-800306b33712 55741-446 HUMAN OTC DRUG Habitrol Step 3 Nicotine Transdermal System Patch PATCH, EXTENDED RELEASE TRANSDERMAL 20150514 NDA NDA020076 Dr. Reddy's Laboratories Inc. NICOTINE 7 mg/24h N 20191231 55741-447_763e5560-549d-d450-5451-800306b33712 55741-447 HUMAN OTC DRUG Habitrol Step 2 Nicotine Transdermal System Patch PATCH, EXTENDED RELEASE TRANSDERMAL 20150514 NDA NDA020076 Dr. Reddy's Laboratories Inc. NICOTINE 14 mg/24h N 20191231 55741-448_763e5560-549d-d450-5451-800306b33712 55741-448 HUMAN OTC DRUG Habitrol Step 1 Nicotine Transdermal System Patch PATCH, EXTENDED RELEASE TRANSDERMAL 20150514 NDA NDA020076 Dr. Reddy's Laboratories Inc. NICOTINE 21 mg/24h N 20191231 55741-524_c373df27-cb2f-8f04-381c-a96c517d35b9 55741-524 HUMAN OTC DRUG Comtrex Cough and Cold Day/Night Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Chlorpheniramine Maleate KIT 20160524 OTC MONOGRAPH FINAL part341 Dr. Reddy's Laboratories Inc. N 20181231 55742-200_44d19040-4d2c-604f-e054-00144ff8d46c 55742-200 HUMAN OTC DRUG PhytoRelief CC HERBAL Menthol LOZENGE ORAL 20170104 OTC MONOGRAPH FINAL part341 Alchem International Private Ltd MENTHOL 7 mg/1 N 20181231 55749-007_2e2436bc-68f5-4bd6-b60e-05d0747cc3be 55749-007 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19870401 NDA NDA207114 Industrial Gas Distributors Inc AIR 1000 mL/L E 20171231 55749-100_a0a1729c-62c4-4904-a564-9d139409e46c 55749-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19870401 NDA NDA205712 Industrial Gas Distributors Inc OXYGEN 990 mL/L E 20171231 55749-300_be57df1a-2adc-44d9-bfc3-9efa9466f96c 55749-300 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19870401 NDA NDA205839 Industrial Gas Distributors Inc NITROGEN 990 mL/L E 20171231 55749-600_7fed4f5d-85d6-4b12-87e7-60bd3719813b 55749-600 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20020101 NDA NDA205704 Industrial Gas Distributors Inc NITROUS OXIDE 990 mL/L E 20171231 5575-0001_40db3bde-e8b0-4e15-ac90-a393b61f92b6 5575-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140224 UNAPPROVED MEDICAL GAS Ecumed Inc dba Aronson Medical OXYGEN 99 L/100L E 20171231 55754-000_1b16f8ba-e9bc-4f85-9ae2-d68193addfae 55754-000 HUMAN OTC DRUG Zohar finest Anticavity Sodium Fluoride MOUTHWASH ORAL 20140205 OTC MONOGRAPH FINAL part355 Broom Lane Enterprises SODIUM FLUORIDE .5 mg/mL E 20171231 55754-121_fe287f6d-45e7-47ea-920c-12ca134d63e3 55754-121 HUMAN OTC DRUG Zohar Toothpaste Fresh Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110228 OTC MONOGRAPH FINAL part355 Broom Lane Enterprises SODIUM MONOFLUOROPHOSPHATE 11.5 mg/g E 20171231 55754-122_0c56a265-60a1-4337-b245-99a631c63364 55754-122 HUMAN OTC DRUG Zohar Toothpaste Cool Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110228 OTC MONOGRAPH FINAL part355 Broom Lane Enterprises SODIUM MONOFLUOROPHOSPHATE 11.5 mg/g E 20171231 55754-123_7fb0ecea-c5ac-4983-acf1-b4031a9cd110 55754-123 HUMAN OTC DRUG Zohar Toothpaste Regular Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110228 OTC MONOGRAPH FINAL part355 Broom Lane Enterprises SODIUM MONOFLUOROPHOSPHATE 11.5 mg/g E 20171231 55758-001_dc1e4930-2a4b-4c2d-8f81-5a4466e12126 55758-001 HUMAN OTC DRUG DoloEar Atropa Belladonna, Apis Mellifera, Aristolochia Clematitis Root, Matricaria Recutita, Lachesis Muta Venom, and Thuja Occidentalis Leafy Twig SOLUTION/ DROPS AURICULAR (OTIC) 20130523 UNAPPROVED HOMEOPATHIC Pharmadel LLC ATROPA BELLADONNA; APIS MELLIFERA; ARISTOLOCHIA CLEMATITIS ROOT; MATRICARIA RECUTITA; LACHESIS MUTA VENOM; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6; 6; 6 [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL N 20181231 55758-002_b20cf0b7-26d7-49a4-810b-ad45c86da53e 55758-002 HUMAN OTC DRUG Arnica ARNICA MONTANA TABLET ORAL 20130527 UNAPPROVED HOMEOPATHIC Pharmadel LLC ARNICA MONTANA 30 [hp_C]/1 N 20181231 55758-004_20cd6922-e370-4cce-affb-a049b9f8d500 55758-004 HUMAN OTC DRUG DOLEX Ibuprofen TABLET ORAL 20130325 ANDA ANDA079129 Pharmadel LLC IBUPROFEN 200 mg/1 N 20181231 55758-006_8b3c6efa-1d13-45df-bad7-fea06fc84091 55758-006 HUMAN OTC DRUG NAPROXEN Naproxen sodium TABLET ORAL 20130325 ANDA ANDA079096 Pharmadel LLC NAPROXEN SODIUM 220 mg/1 N 20181231 55758-007_6066d862-e8bb-6a85-e053-2a91aa0ac474 55758-007 HUMAN OTC DRUG SanaTos Childrens Mucus Relief Cough DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN LIQUID ORAL 20131010 OTC MONOGRAPH FINAL part341 Pharmadel LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20191231 55758-009_601e629c-d997-b73d-e053-2a91aa0ae9db 55758-009 HUMAN OTC DRUG SanaTos Severe Cold and Cough Nighttime Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride GRANULE, FOR SOLUTION ORAL 20140220 OTC MONOGRAPH FINAL part341 Pharmadel LLC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN 25; 10; 650 mg/1; mg/1; mg/1 N 20181231 55758-010_526c3cf7-9ffa-101c-e054-00144ff88e88 55758-010 HUMAN OTC DRUG SanaTos Severe Cold and Cough Day Time Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride GRANULE, FOR SOLUTION ORAL 20140220 OTC MONOGRAPH FINAL part341 Pharmadel LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 55758-013_60437d86-9e14-8d8a-e053-2991aa0a2317 55758-013 HUMAN OTC DRUG SanaTos Children Cough and Congestion Cherry DEXTROMETHORPHAN HBr and GUAIFENESIN LIQUID ORAL 20160101 OTC MONOGRAPH FINAL part341 Pharmadel LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 55758-017_4769d6db-bd4b-2844-e054-00144ff8d46c 55758-017 HUMAN OTC DRUG Parche Leon Milagroso Capsaicin, Camphor, Menthol PATCH TOPICAL 20141205 OTC MONOGRAPH NOT FINAL part348 Pharmadel LLC CAPSAICIN; CAMPHOR (SYNTHETIC); MENTHOL .025; 3; 1.25 g/100g; g/100g; g/100g N 20181231 55758-018_f0248867-fab2-4727-ae6e-dbba837d0a58 55758-018 HUMAN OTC DRUG Vitapirena Camphor, Eucalyptus, Menthol OINTMENT TOPICAL 20140101 OTC MONOGRAPH FINAL part341 Pharmadel LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g N 20181231 55758-022_60506714-179d-6714-e053-2991aa0a51b3 55758-022 HUMAN OTC DRUG Sanatos Multi Symptom Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI LIQUID ORAL 20141201 OTC MONOGRAPH FINAL part341 Pharmadel LLC DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN 10; 5; 325 mg/30mL; mg/30mL; mg/30mL N 20181231 55758-023_6052e596-3f50-043b-e053-2a91aa0a053f 55758-023 HUMAN OTC DRUG Sanatos Nighttime Multi Symptoms Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20141201 OTC MONOGRAPH FINAL part341 Pharmadel LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN 30; 12.5; 650 mg/30mL; mg/30mL; mg/30mL N 20181231 55758-046_36969358-04f2-5cad-e054-00144ff88e88 55758-046 HUMAN OTC DRUG Parche Leon Milagroso Dual Action Capsaicin, Menthol PATCH TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part348 Pharmadel LLC MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g E 20171231 55758-100_c71072ec-9d04-41de-b625-ff32c62c1ce1 55758-100 HUMAN OTC DRUG Kofal T Methyl Salicylate OINTMENT TOPICAL 20120221 OTC MONOGRAPH NOT FINAL part348 Pharmadel LLC METHYL SALICYLATE 10.5 g/100g N 20181231 55758-253_487f72e0-e2c7-32ea-e054-00144ff8d46c 55758-253 HUMAN OTC DRUG El piojito Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20101028 OTC MONOGRAPH FINAL part358G Pharmadel PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 55758-305_a6f85661-078f-4ddf-9605-5cee3e8d8726 55758-305 HUMAN OTC DRUG Estomax Bismuth Subsalicylate LIQUID ORAL 20120221 OTC MONOGRAPH FINAL part335 Pharmadel LLC BISMUTH SUBSALICYLATE 262 mg/15mL E 20171231 55777-0100_f9cbe524-b648-4468-9e70-94f0d552e743 55777-0100 HUMAN OTC DRUG Burn Out SPF-30 Sunscreen Zinc Oxide LOTION TOPICAL 20130912 OTC MONOGRAPH FINAL part352 Sun Research LLC ZINC OXIDE 20 g/100mL E 20171231 55789-0101_0eaa0c8d-d12d-4f32-a23b-6c7e6f7b1399 55789-0101 HUMAN OTC DRUG SPF-40 facial moisturizer Zinc Oxide and Titanium dioxide LOTION TOPICAL 20121210 OTC MONOGRAPH NOT FINAL part352 Mineral Fusion brands ZINC OXIDE; TITANIUM DIOXIDE 5; 7.5 g/100mL; g/100mL E 20171231 55789-1734_07c54f1b-74f7-46cc-86c6-1d57a4368e12 55789-1734 HUMAN OTC DRUG Anti-Dandruff Salicylic Acid SHAMPOO TOPICAL 20130801 OTC MONOGRAPH FINAL part358H Mineral Fusion Natural Brands SALICYLIC ACID 20 mg/mL E 20171231 55789-2400_a1adbbfb-f44a-421c-a28b-a68058711298 55789-2400 HUMAN OTC DRUG Perfecting Mineral Beauty Balm with SPF 9 Titanium Dioxide CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Mineral Fusion Natural Brands LLC TITANIUM DIOXIDE 39 mg/mL E 20171231 55789-2401_a5d00319-22c6-4819-b69d-18a68a9daeb8 55789-2401 HUMAN OTC DRUG Illuminating Mineral Beauty Balm with SPF 9 Titanium Dioxide CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Mineral Fusion Natural Brands LLC TITANIUM DIOXIDE 74 mg/mL E 20171231 55789-2403_730bf52d-6063-45a8-9692-2c801ea6a9de 55789-2403 HUMAN OTC DRUG BRONZING MINERAL BEAUTY BALM SPF 15 TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part352 Mineral Fusion Natural Brands TITANIUM DIOXIDE; ZINC OXIDE 3.6; 2.4 g/60mL; g/60mL E 20171231 55789-2901_2f4bf84d-6552-4501-87fc-10ea7e03747b 55789-2901 HUMAN OTC DRUG SPF 16 BRIGHTENING ZINC OXIDE CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part352 Mineral Fusion Natural Brands ZINC OXIDE 2.94 g/28g E 20171231 55789-2902_a33d9d10-3445-4ac7-8709-9195361b68e1 55789-2902 HUMAN OTC DRUG MINERAL SPF 30 SUN TITANIUM DIOXIDE and ZINC OXIDE STICK TOPICAL 20140801 OTC MONOGRAPH FINAL part352 Mineral Fusion Natural Brands TITANIUM DIOXIDE; ZINC OXIDE .475; .95 g/9.5g; g/9.5g E 20171231 55789-2905_5118cd3b-dc47-48c8-9913-088ed394bb0d 55789-2905 HUMAN OTC DRUG SPF 15 BRIGHTENING MOISTURIZER ZINC OXIDE CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part352 Mineral Fusion Natural Brands ZINC OXIDE 10.8 g/96g E 20171231 55789-3104_21643b35-625e-4563-a8fc-bcd97a062085 55789-3104 HUMAN OTC DRUG SPF 16 AGE-DEFYING TREATMENT SERUM TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part352 Mineral Fusion Natural Brands TITANIUM DIOXIDE; ZINC OXIDE 3.36; 3.36 g/96g; g/96g E 20171231 55789-3106_a058557e-674e-4aea-b8eb-b2dd2321a091 55789-3106 HUMAN OTC DRUG MOISTURIZER SPF 15 TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part352 Mineral Fusion Natural Brands TITANIUM DIOXIDE; ZINC OXIDE 3.36; 3.36 g/96g; g/96g E 20171231 55792-007_0db1cf70-2a0f-451d-b272-b2feccf8ce61 55792-007 HUMAN PRESCRIPTION DRUG Elliotts B sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate INJECTION INTRATHECAL 20130604 NDA NDA020577 Lukare Medical, LLC SODIUM CHLORIDE; SODIUM BICARBONATE; ANHYDROUS DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; SODIUM PHOSPHATE 73; 19; 8; 3; 3; 2; 2 mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 55801-108_69f7b45a-f4e4-45eb-baa2-641dbb5540d3 55801-108 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20170227 ANDA ANDA207201 APPCO PHARMA LLCC GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 55801-117_69f7b45a-f4e4-45eb-baa2-641dbb5540d3 55801-117 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20170227 ANDA ANDA207201 APPCO PHARMA LLCC GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 55801-132_2937dd24-471b-409a-8868-45376b8ed417 55801-132 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20171101 ANDA ANDA207196 APPCO PHARMA LLC MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] N 20181231 55801-133_2937dd24-471b-409a-8868-45376b8ed417 55801-133 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20171101 ANDA ANDA207196 APPCO PHARMA LLC MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] N 20181231 55801-313_1987c41d-364c-4839-9fdd-423b64dad2e3 55801-313 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET ORAL 20170201 ANDA ANDA206974 APPCO PHARMA LLC LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 55801-314_1987c41d-364c-4839-9fdd-423b64dad2e3 55801-314 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET ORAL 20170201 ANDA ANDA206974 APPCO PHARMA LLC LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 55801-322_e53c9020-5583-47f8-9039-752abd023cea 55801-322 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20170915 ANDA ANDA206973 APPCO PHARMA LLC ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 55801-323_e53c9020-5583-47f8-9039-752abd023cea 55801-323 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20170915 ANDA ANDA206973 APPCO PHARMA LLC ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 55801-332_b87b650c-9a4b-4c82-975e-f62d12f20487 55801-332 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET ORAL 20160526 ANDA ANDA206762 APPCO PHARMA LLC VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 55801-333_b87b650c-9a4b-4c82-975e-f62d12f20487 55801-333 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET ORAL 20160526 ANDA ANDA206762 APPCO PHARMA LLC VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 55801-355_49b10531-f2c8-434c-b8ba-78f9fd9d095b 55801-355 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET ORAL 20180201 ANDA ANDA209025 APPCO PHARMA LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 55801-520_5a25019e-7606-41b8-a980-86c26fd46db1 55801-520 HUMAN PRESCRIPTION DRUG Budesonide budesonide CAPSULE ORAL 20170601 ANDA ANDA207367 APPCO PHARMA LLC BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 55806-020_d0d6ed35-8da8-4246-b7cc-0b1f3097097b 55806-020 HUMAN PRESCRIPTION DRUG methazolamide methazolamide TABLET ORAL 19940718 ANDA ANDA040062 Effcon Laboratories, Inc. METHAZOLAMIDE 50 mg/1 N 20181231 55806-021_d0d6ed35-8da8-4246-b7cc-0b1f3097097b 55806-021 HUMAN PRESCRIPTION DRUG methazolamide methazolamide TABLET ORAL 19940714 ANDA ANDA040062 Effcon Laboratories, Inc. METHAZOLAMIDE 25 mg/1 N 20181231 55813-123_23bde802-d853-1ecc-e054-00144ff88e88 55813-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20151027 UNAPPROVED MEDICAL GAS Advanced Home Care OXYGEN 99 L/100L E 20171231 55814-101_9f65092c-ce91-4e09-92a6-31ed3fb2f3cd 55814-101 HUMAN OTC DRUG HAND SANITIZING LAVENDER ALCOHOL SPRAY TOPICAL 20120218 OTC MONOGRAPH FINAL part333E DR. BRONNER'S MAGIC SOAPS ALCOHOL 62 mL/100mL E 20171231 55856-0001_5d2922d3-8c21-4abf-b395-56898a1fca89 55856-0001 HUMAN OTC DRUG HGH Adrenalinum, Thyroidinum (suis), Insulinum, Pituitiaria glandula (suis) LIQUID ORAL 20150109 UNAPPROVED HOMEOPATHIC Life Choice Ltd. EPINEPHRINE; SUS SCROFA THYROID; INSULIN PORK; SUS SCROFA PITUITARY GLAND 9; 9; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 55856-0002_14828c2b-fda1-4539-8ba6-eba09c0b54ce 55856-0002 HUMAN OTC DRUG THYROID SUPPORT CAUSTICUM, NATRUM MURIATICUM, CALCAREA IODATA, FUCUS VESICULOSUS, KALI IODATUM, FERRUM IODATUM, THYROIDINUM (BOVINE) LIQUID ORAL 20141212 UNAPPROVED HOMEOPATHIC Life Choice Ltd. CAUSTICUM; SODIUM CHLORIDE; CALCIUM IODIDE; FUCUS VESICULOSUS; POTASSIUM IODIDE; FERROUS IODIDE; THYROID, BOVINE 3; 3; 6; 6; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55856-0003_186066ab-3f6f-400a-bb08-aec56b7f1af5 55856-0003 HUMAN PRESCRIPTION DRUG HGH Plus Adrenalinum, Thyroidinum (suis), Insulinum, Pituitaria Glandula (suis), LIQUID ORAL 20140310 UNAPPROVED HOMEOPATHIC Life Choice Ltd. EPINEPHRINE; SUS SCROFA THYROID; INSULIN HUMAN; SUS SCROFA PITUITARY GLAND 9; 9; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Insulin [Chemical/Ingredient],Insulin [EPC] N 20181231 55858-123_25ed22e2-f190-4ba5-e054-00144ff88e88 55858-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20151202 UNAPPROVED MEDICAL GAS Care Home Medical OXYGEN 99 L/100L E 20171231 55863-155_4e2722ed-a7ed-5bf0-e054-00144ff8d46c 55863-155 HUMAN OTC DRUG SOFTCIDE CHLOROXYLENOL SOAP TOPICAL 20170410 OTC MONOGRAPH NOT FINAL part333A Erie Scientific LLC CHLOROXYLENOL .001 mg/100mL N 20181231 55863-281_5de72152-9b3f-426d-9916-df7e9ef384b4 55863-281 HUMAN OTC DRUG SoftCIDE-ES SoftCIDE-ES LIQUID TOPICAL 20130613 OTC MONOGRAPH NOT FINAL part333E Erie Scientific, LLC CHLOROXYLENOL 12.604 g/100mL E 20171231 55863-431_9f9a0274-9fb4-4a96-b036-20ff1295c1f3 55863-431 HUMAN OTC DRUG Alcoscrub Foam Alcoscrub Foam LIQUID TOPICAL 20060112 OTC MONOGRAPH NOT FINAL part333E Erie Scientific, LLC ALCOHOL 1 mL/mL E 20171231 55863-700_81b6e3a7-2c4b-45b3-9ac6-d9fc6ed86415 55863-700 HUMAN OTC DRUG Alcoscrub Hand Cleaner Alcohol LIQUID TOPICAL 20090103 OTC MONOGRAPH NOT FINAL part333E Erie Scientific, LLC. ALCOHOL 1 mL/mL E 20171231 55873-001_ea41661a-f6c8-4ca7-958f-f68fd9dbdb73 55873-001 HUMAN OTC DRUG OralLine Secure SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 19660101 OTC MONOGRAPH FINAL part355 J.M. Murray Center Inc. SODIUM FLUORIDE .24 g/100g N 20181231 55873-002_ea41661a-f6c8-4ca7-958f-f68fd9dbdb73 55873-002 HUMAN OTC DRUG OralLine SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19660101 OTC MONOGRAPH FINAL part355 J.M. Murray Center Inc. SODIUM FLUORIDE .24 g/100g N 20181231 55873-003_146dc009-aa0a-41d1-bbfb-207cb08843b8 55873-003 HUMAN OTC DRUG OralLine Kids SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19660101 OTC MONOGRAPH FINAL part355 J.M. Murray Center Inc. SODIUM FLUORIDE .24 g/100g N 20181231 55873-004_146dc009-aa0a-41d1-bbfb-207cb08843b8 55873-004 HUMAN OTC DRUG OralLine Kids SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19660101 OTC MONOGRAPH FINAL part355 J.M. Murray Center Inc. SODIUM FLUORIDE .24 g/100g N 20181231 55873-021_9bb30d63-c52e-4a56-b779-6321c81a7397 55873-021 HUMAN OTC DRUG OraLine-Secure CLEAR ANTIPERSPIRANT/DEODORANT ALUMINUM CHLOROHYDRATE GEL TOPICAL 20140501 OTC MONOGRAPH FINAL part350 J.M. Murray Center Inc. ALUMINUM CHLOROHYDRATE 5.67 g/56.7g N 20181231 55878-101_f6f260e0-3085-4d89-8709-27656c643b41 55878-101 HUMAN OTC DRUG ACNE TREATMENT SERUM BENZOYL PEROXIDE GEL TOPICAL 20130207 OTC MONOGRAPH FINAL part333D Halogent, LLC (DBA Exposed Skin Care) BENZOYL PEROXIDE 3.5 g/100mL E 20171231 55878-102_901daf24-fae9-4f3f-bb9f-7a7e65af2af9 55878-102 HUMAN OTC DRUG CLARIFYING MASK SULFUR RESORCINOL PASTE TOPICAL 20130207 OTC MONOGRAPH FINAL part333D Halogent, LLC (DBA Exposed Skin Care) SULFUR; RESORCINOL 3; 2 g/100mL; g/100mL E 20171231 55878-103_1355feda-1a95-40a3-9c26-1bafb1939f35 55878-103 HUMAN OTC DRUG CLEAR PORE SERUM SALICYLIC ACID GEL TOPICAL 20130207 OTC MONOGRAPH FINAL part333D Halogent, LLC (DBA Exposed Skin Care) SALICYLIC ACID 1 g/100mL E 20171231 55878-104_550de9bb-a6c4-4e1b-9bdf-b0aff71963e0 55878-104 HUMAN OTC DRUG CLEARING TONIC SALICYLIC ACID LIQUID TOPICAL 20130207 OTC MONOGRAPH FINAL part333D Halogent, LLC (DBA Exposed Skin Care) SALICYLIC ACID 1 g/100mL E 20171231 55878-105_2dfe05ea-f794-448c-9a9e-a0645b9765b5 55878-105 HUMAN OTC DRUG FACIAL CLEANSER SALICYLIC ACID GEL TOPICAL 20130207 OTC MONOGRAPH FINAL part333D Halogent, LLC (DBA Exposed Skin Care) SALICYLIC ACID .5 g/100mL E 20171231 55878-106_81d6b25e-ac30-46cb-a7e7-a3ea7d1d7d7a 55878-106 HUMAN OTC DRUG CLARIFYING MASK SULFUR, RESORCINOL PASTE TOPICAL 20130207 OTC MONOGRAPH FINAL part333D Halogent, LLC (DBA Exposed Skin Care) SULFUR; RESORCINOL 3; 2 g/100mL; g/100mL E 20171231 55882-6011_5b99b0e3-25c0-415c-9bd1-36532d3634e9 55882-6011 HUMAN OTC DRUG Hello Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130304 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g E 20171231 55882-6012_5b99b0e3-25c0-415c-9bd1-36532d3634e9 55882-6012 HUMAN OTC DRUG Hello Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130304 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g E 20171231 55882-6013_5b99b0e3-25c0-415c-9bd1-36532d3634e9 55882-6013 HUMAN OTC DRUG Hello Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130304 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g E 20171231 55882-6014_5b99b0e3-25c0-415c-9bd1-36532d3634e9 55882-6014 HUMAN OTC DRUG Hello Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130304 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g E 20171231 55882-6092_2fc8ec39-707f-4083-a1b2-b186bd60070d 55882-6092 HUMAN OTC DRUG Hello Sodium fluoride PASTE, DENTIFRICE DENTAL 20150301 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g E 20171231 55882-6093_2fc8ec39-707f-4083-a1b2-b186bd60070d 55882-6093 HUMAN OTC DRUG Hello Sodium fluoride PASTE, DENTIFRICE DENTAL 20150301 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g E 20171231 55882-6094_2fc8ec39-707f-4083-a1b2-b186bd60070d 55882-6094 HUMAN OTC DRUG Hello Sodium fluoride PASTE, DENTIFRICE DENTAL 20150301 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g E 20171231 55882-6095_2fc8ec39-707f-4083-a1b2-b186bd60070d 55882-6095 HUMAN OTC DRUG Hello Sodium fluoride PASTE, DENTIFRICE DENTAL 20150301 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g E 20171231 55882-6096_201133d8-a6f2-4297-8420-2dfb95eab9a6 55882-6096 HUMAN OTC DRUG Hello Sodium fluoride PASTE, DENTIFRICE DENTAL 20160101 OTC MONOGRAPH FINAL part355 Hello Products LLC SODIUM FLUORIDE 1.5 mg/g E 20171231 55882-6097_95456c75-458d-46b5-920f-05230dd46eed 55882-6097 HUMAN OTC DRUG Hello Potassium nitrate and Sodium fluoride PASTE, DENTIFRICE DENTAL 20170215 OTC MONOGRAPH NOT FINAL part356 Hello Products LLC POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 55885-010_b5134f32-b069-4536-a59f-f2627a549933 55885-010 HUMAN OTC DRUG THE QUEEN ROSE WITCH HAZEL LIQUID TOPICAL 20121201 OTC MONOGRAPH FINAL part347 LaLa Co., Ltd. WITCH HAZEL .005 mg/5mL N 20181231 55885-020_24a1d06b-67ed-4a92-b4d3-e1f2223e434d 55885-020 HUMAN OTC DRUG Roseday Rose Witch Hazel LIQUID TOPICAL 20170901 OTC MONOGRAPH FINAL part347 LaLa Co., Ltd. WITCH HAZEL .25 g/5mL N 20181231 55891-001_e69c5dfb-6e58-471e-a29d-e6136bbddfff 55891-001 HUMAN OTC DRUG flawless by Sonya aloe BB creme NUDE SPF 20 Sunscreen TITANIUM DIOXIDE CREAM TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 Forever Living Products TITANIUM DIOXIDE 7 g/100g N 20181231 55891-002_f195a273-449e-44e4-a6e1-26db7d88d440 55891-002 HUMAN OTC DRUG flawless by Sonya aloe BB creme COCOA SPF 10 Sunscreen TITANIUM DIOXIDE CREAM TOPICAL 20130207 OTC MONOGRAPH NOT FINAL part352 Forever Living Products TITANIUM DIOXIDE 3 g/100g N 20181231 55910-000_c7527b41-7c78-462d-ad32-dc3fb8c6e281 55910-000 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium, sennosides TABLET ORAL 20150430 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 55910-001_50689044-9533-4d11-b039-67571522748a 55910-001 HUMAN OTC DRUG First Aid Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part333E Dolgencorp LLC POVIDONE-IODINE 10 mg/mL N 20181231 55910-002_d6ad5ea6-4228-424b-bd3a-edeb0c72e2c7 55910-002 HUMAN OTC DRUG rexall enema Saline ENEMA RECTAL 20100813 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, LLC SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 55910-005_5f017867-17bd-5d02-e053-2a91aa0a7bbe 55910-005 HUMAN OTC DRUG DG Health Sterile Advanced Relief Eye Dextran 70 SOLUTION/ DROPS OPHTHALMIC 20130630 OTC MONOGRAPH FINAL part349 Dolgencorp Inc DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mg/mg; mg/mg; mg/mg; mg/mg N 20181231 55910-006_5f0161ac-249e-3cb4-e053-2a91aa0a627a 55910-006 HUMAN OTC DRUG DG HEALTH MAXIMUM REDNESS RELIEF GLYCERIN, NAPHAZOLINE HCL SOLUTION/ DROPS OPHTHALMIC 20141124 OTC MONOGRAPH FINAL part349 DOLGENCORP INC GLYCERIN; NAPHAZOLINE HYDROCHLORIDE .0025; .00012 mg/mL; mg/mL N 20181231 55910-007_5666f818-676f-1c27-e054-00144ff88e88 55910-007 HUMAN OTC DRUG Athletes Foot Tolnaftate SPRAY TOPICAL 20141104 OTC MONOGRAPH FINAL part333C DOLGENCORP, LLC. TOLNAFTATE 1 g/100g N 20181231 55910-009_80420a74-d540-4871-aa8d-fc908e785fc4 55910-009 HUMAN OTC DRUG DG Health Pain Relief Acetaminophen TABLET, FILM COATED ORAL 20150818 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 500 mg/1 N 20181231 55910-010_60eb35ab-b5b6-4fdb-b9c2-d472cebb116e 55910-010 HUMAN OTC DRUG dg health childrens pain and fever Acetaminophen SUSPENSION ORAL 20150423 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 55910-011_a772437f-fff0-4c12-bbfd-86251398538a 55910-011 HUMAN OTC DRUG dg health heartburn relief Ranitidine TABLET, FILM COATED ORAL 20151123 ANDA ANDA091429 Dolgencorp, LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 55910-013_0ed95c8b-8127-4044-bb5e-b83b96a9128f 55910-013 HUMAN OTC DRUG Mucus Relief Severe Cough and Congestion dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride SOLUTION ORAL 20120214 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 55910-014_94944f39-bb69-46c3-9a27-501737cbbda3 55910-014 HUMAN OTC DRUG DG Health cold multi symptom nite time Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20091005 OTC MONOGRAPH FINAL part341 Dolgencorp Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55910-015_c4251972-5e95-4e67-a044-9d4770ca4662 55910-015 HUMAN OTC DRUG DG Health Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20150929 OTC MONOGRAPH FINAL part331 Dolgencorp, LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 55910-019_f7d03548-9a33-450e-bc00-725f269b1549 55910-019 HUMAN OTC DRUG DG Health Clear Time Oxymetazoline Hydrochloride SPRAY NASAL 20150501 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 55910-020_b9d2c809-f2e9-49b6-9eb8-b956b8be310d 55910-020 HUMAN OTC DRUG Diaper Rash Zinc oxide PASTE TOPICAL 20120510 OTC MONOGRAPH FINAL part347 DOLGENCORP, LLC ZINC OXIDE 532 mg/g N 20181231 55910-021_ae37fd35-a8a2-44eb-9789-c304bebf161b 55910-021 HUMAN OTC DRUG Pain and Fever Relief Infants Acetaminophen SUSPENSION ORAL 20150430 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN 160 mg/5mL N 20181231 55910-023_b7e0d07d-11e7-45e9-83c6-15f20168e2bd 55910-023 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20150531 ANDA ANDA076460 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) IBUPROFEN 200 mg/1 N 20181231 55910-026_7b328157-a374-416a-b102-07a092a22ac6 55910-026 HUMAN OTC DRUG Rexall Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130807 ANDA ANDA072096 Dolgencorp, LLC IBUPROFEN 200 mg/1 N 20181231 55910-027_01686349-c761-4004-899f-58ae8006dff2 55910-027 HUMAN OTC DRUG DG Health Athletes Foot Tolnaftate CREAM TOPICAL 20151105 OTC MONOGRAPH FINAL part333C Dolgencorp, LLC TOLNAFTATE 10 mg/g N 20181231 55910-028_b4781298-06d5-45e4-a4db-f55c9d88bf73 55910-028 HUMAN OTC DRUG DG Health Allergy Relief Fluticasone propionate SPRAY, METERED NASAL 20160708 ANDA ANDA207957 Dolgencorp, LLC FLUTICASONE PROPIONATE 50 ug/1 N 20181231 55910-029_60a0b8ff-6655-590d-e053-2a91aa0af592 55910-029 HUMAN OTC DRUG Undecylenic Acid Antifungal Nail Pen LIQUID TOPICAL 20160112 OTC MONOGRAPH FINAL part333C Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) UNDECYLENIC ACID 25 mg/1.7mL N 20181231 55910-030_22bbec42-80f0-46d7-a43d-c82131883571 55910-030 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20150224 OTC MONOGRAPH FINAL part355 DOLGENCORP, LLC SODIUM FLUORIDE 10.4 mg/mL N 20191231 55910-031_20ce6340-2ace-431c-a21b-fe6789ec714c 55910-031 HUMAN OTC DRUG Childrens Plus Flu Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, Phenylephrine HCI SUSPENSION ORAL 20150531 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 55910-033_dbd82e55-0bb4-40a1-b6fd-c0e633ed73b5 55910-033 HUMAN OTC DRUG Mucus Relief Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 55910-034_a04ded46-06b4-49d9-8fe0-1873dd7e2cc6 55910-034 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20100629 OTC MONOGRAPH FINAL part333D Dolgencorp, LLC SALICYLIC ACID 19.8 mg/g N 20181231 55910-035_19ac0b01-6b15-4cc0-8d84-a36905fb4d22 55910-035 HUMAN OTC DRUG Cold Multi-Symptom Severe Day Time Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20191231 55910-037_0945d708-4225-4a05-bdd2-9fc9a08c51f9 55910-037 HUMAN OTC DRUG Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 55910-038_2e20b017-6f85-4c66-93db-e86ff5fdfc8a 55910-038 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 19931021 OTC MONOGRAPH NOT FINAL part334 DOLGENCORP, LLC MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 55910-042_046fe3a3-a818-447d-b91d-55918a7c19ae 55910-042 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131120 OTC MONOGRAPH FINAL part347 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIMETHICONE 125 mg/1 N 20181231 55910-043_366270f5-4736-4729-bea0-fe69892fe92f 55910-043 HUMAN OTC DRUG Childrens Plus Multi Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride SUSPENSION ORAL 20150430 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 55910-044_2ec1521b-dc99-4bfa-9ec3-418617809a52 55910-044 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DOCUSATE SODIUM 100 mg/1 N 20181231 55910-045_6e48ae05-1d90-40b0-b627-9c23cc5dbf51 55910-045 HUMAN OTC DRUG NiteTime Cold plus Flu Releif Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20141030 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 55910-050_7ea1ad05-43a1-4f71-b220-0b3d86800dd1 55910-050 HUMAN OTC DRUG dg health Ibuprofen pm diphenhydramine citrate and ibuprofen TABLET, COATED ORAL 20100124 ANDA ANDA079113 Dolgencorp Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 55910-051_5d6b6c19-a64f-69db-e053-2a91aa0acd60 55910-051 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20160322 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 5.4 mg/1 N 20181231 55910-051_5d6bb497-29e5-0ec7-e053-2991aa0af5ba 55910-051 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20160322 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 5.4 mg/1 N 20181231 55910-052_5d6c6200-1166-de46-e053-2991aa0a7674 55910-052 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20160322 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 5.8 mg/1 N 20181231 55910-052_5d6c668a-80b6-de18-e053-2991aa0a38fb 55910-052 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20160322 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 5.8 mg/1 N 20181231 55910-052_5d6ca99c-48a6-6288-e053-2a91aa0ae884 55910-052 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20160722 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 5.8 mg/1 N 20181231 55910-053_5d6ce583-3f4e-3def-e053-2991aa0ab520 55910-053 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20160322 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 7.5 mg/1 N 20181231 55910-053_5d6ce583-3f5f-3def-e053-2991aa0ab520 55910-053 HUMAN OTC DRUG Honey Lemon cough drops menthol LOZENGE ORAL 20160722 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 7.5 mg/1 N 20181231 55910-053_5d6cf1e6-5853-471d-e053-2991aa0a4b50 55910-053 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20160322 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 7.5 mg/1 N 20181231 55910-054_00cbd087-fc20-4b37-91ff-170c7d289a42 55910-054 HUMAN OTC DRUG Cold and Flu Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55910-055_c488da1a-ffeb-4376-9f51-990e0905b656 55910-055 HUMAN OTC DRUG DG Body Travel Pack Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Dolgencorp, LLC BENZALKONIUM CHLORIDE .115 g/1 N 20181231 55910-057_78f524ac-3498-480d-8979-653c8a5c5674 55910-057 HUMAN OTC DRUG Health Sense Infants Ibuprofen Oral Suspension ibuprofen SUSPENSION ORAL 20090608 ANDA ANDA075217 Dolgencorp Inc IBUPROFEN 50 mg/1.25mL N 20181231 55910-058_5d7b765f-8389-0ed3-e053-2a91aa0af823 55910-058 HUMAN OTC DRUG Strawberry Cough Drops Menthol LOZENGE ORAL 20160322 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 2.7 mg/1 N 20181231 55910-059_5d7bc6b1-7807-4b88-e053-2a91aa0a9fc6 55910-059 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20160322 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 5.8 mg/1 N 20181231 55910-059_5d7bf681-a031-4db1-e053-2991aa0a78e8 55910-059 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20160322 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 5.8 mg/1 N 20181231 55910-060_5d7c6d84-7e33-1986-e053-2991aa0a217f 55910-060 HUMAN OTC DRUG Sugar Free Cherry Cough Drops Menthol LOZENGE ORAL 20160322 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 5.8 mg/1 N 20181231 55910-061_3a768376-30c8-450d-8d76-4f8146420015 55910-061 HUMAN OTC DRUG DG Health Antibiotic Neomycin, Polymyxin B, Pramoxine HCl CREAM TOPICAL 20110114 OTC MONOGRAPH FINAL part333B Dolgencorp Inc NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 3.5; 10; 10000 mg/g; mg/g; [USP'U]/g N 20181231 55910-062_5d7d0c0f-40ab-9a58-e053-2991aa0a49db 55910-062 HUMAN OTC DRUG sugar free honey lemon cough drops menthol LOZENGE ORAL 20160322 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 7.6 mg/1 N 20181231 55910-063_1f827d06-0da9-4486-97e1-47ba3738ef1f 55910-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 20090413 OTC MONOGRAPH FINAL part346 Dolgencorp, LLC FERRIC OXIDE RED; ZINC OXIDE .8; .8 kg/100L; kg/100L N 20181231 55910-064_3d2dd959-d2a0-5130-e054-00144ff8d46c 55910-064 HUMAN OTC DRUG herbal cough drops menthol LOZENGE ORAL 20160616 OTC MONOGRAPH FINAL part341 Dollar General Corporation MENTHOL 4.8 mg/1 N 20181231 55910-065_3d2eba64-2e75-03f1-e054-00144ff8d46c 55910-065 HUMAN OTC DRUG cherry sore throat lozenge Benzocaine LOZENGE ORAL 20150817 OTC MONOGRAPH NOT FINAL part356 Dollar General Corporation BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 55910-066_3d6fe13f-2dfc-3c80-e054-00144ff88e88 55910-066 HUMAN OTC DRUG mixed berry sore throat and cough lozenge benzocaine LOZENGE ORAL 20160513 OTC MONOGRAPH NOT FINAL part356 Dollar General Corporation BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20181231 55910-067_9ecd0226-feba-41ab-bceb-a4cf1ebfa027 55910-067 HUMAN OTC DRUG DG Health Triple Antibiotic bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20100207 OTC MONOGRAPH FINAL part333 Dolgencorp Inc BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 55910-068_51bd4feb-22e2-4d47-9956-0b6cbf836f26 55910-068 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL part333B DOLGENCORP, LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 55910-069_7cfb4472-810f-4115-82ca-0fcdec993f31 55910-069 HUMAN OTC DRUG Pure petroleum White Petrolatum JELLY TOPICAL 19981115 OTC MONOGRAPH FINAL part347 Dolgencorp LLC PETROLATUM 1 g/g N 20181231 55910-070_40ce1140-4404-03e9-e054-00144ff8d46c 55910-070 HUMAN OTC DRUG Assorted Fruit Flavor Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20160322 OTC MONOGRAPH FINAL part331 Dollar General Corporation CALCIUM CARBONATE 750 mg/1 N 20181231 55910-073_5d7db187-45d2-52bf-e053-2a91aa0a116f 55910-073 HUMAN OTC DRUG Berry Breezer Throat Drops Pectin LOZENGE ORAL 20160322 OTC MONOGRAPH NOT FINAL part356 Dollar General Corporation PECTIN 7 mg/1 N 20181231 55910-074_3656951e-b6e6-4667-92fa-5d523874d44c 55910-074 HUMAN OTC DRUG DG Health Ibuprofen Ibuprofen TABLET, COATED ORAL 20100201 ANDA ANDA077349 Dolgencorp, LLC IBUPROFEN 200 mg/1 N 20181231 55910-075_a50c8d26-fe07-47c9-821b-b17c1e1cc5f8 55910-075 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141130 NDA NDA021920 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) NAPROXEN SODIUM 220 mg/1 N 20181231 55910-077_4adaeeb7-3c96-4d67-e054-00144ff8d46c 55910-077 HUMAN OTC DRUG Heartburn and Gas Antacid Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20170228 OTC MONOGRAPH FINAL part331 DOLGENCORP, LLC CALCIUM CARBONATE; DIMETHICONE 750; 80 mg/1; mg/1 N 20181231 55910-079_4adc8290-167e-4b3f-e054-00144ff88e88 55910-079 HUMAN OTC DRUG Assorted Fruit Cough Drops Menthol LOZENGE ORAL 20170228 OTC MONOGRAPH FINAL part341 DOLGENCORP LLC MENTHOL 2.8 mg/1 N 20181231 55910-081_e0fd1ade-9bab-4070-b46d-af19cbe373b7 55910-081 HUMAN OTC DRUG dg health miconazole 3 Miconazole nitrate KIT 20100222 ANDA ANDA075329 Dolgencorp Inc N 20181231 55910-085_81fcdf17-9a8d-4b08-bdeb-2a320cc7a13e 55910-085 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20170310 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP,LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55910-086_4211ad36-10e6-43ee-8524-5bbce661cb0d 55910-086 HUMAN OTC DRUG Hand wash Benzalkonium chloride SOAP TOPICAL 20150123 OTC MONOGRAPH NOT FINAL part333A Dolgencorp, LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55910-091_ae1f2825-2cc8-4039-8a43-48050f77a8b9 55910-091 HUMAN OTC DRUG Allergy Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 55910-094_3deabbf5-fe4f-4659-859b-3bb1a4ab70dd 55910-094 HUMAN OTC DRUG DG Health nasal decongestant pe maximum strength Phenylephrine Hydrochloride TABLET ORAL 20100129 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 55910-096_a0410a93-7278-4b97-bf9b-471d36b2223d 55910-096 HUMAN OTC DRUG dg health flu and severe cold and cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20110524 OTC MONOGRAPH FINAL part341 Dolgencorp Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 55910-099_876cb5eb-c465-4751-b5a1-c25a20f2ed10 55910-099 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20040819 OTC MONOGRAPH NOT FINAL part356 DOLGENCORP,LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55910-101_b502d291-96d8-436b-afd9-5ca104f879aa 55910-101 HUMAN OTC DRUG DG BODY TONIC SALICYLIC ACID LIQUID TOPICAL 20150302 OTC MONOGRAPH FINAL part333D DOLGENCORP INC SALICYLIC ACID 20 mg/mL N 20181231 55910-102_ad8475b3-ace1-4a05-b927-3286a8139cb4 55910-102 HUMAN OTC DRUG dg health childrens ibuprofen Ibuprofen SUSPENSION ORAL 20160420 ANDA ANDA074937 Dolgencorp, LLC IBUPROFEN 100 mg/5mL N 20181231 55910-104_39892649-5cd3-4e05-b3d1-899026bd25d9 55910-104 HUMAN OTC DRUG Oil-Free Astringent Salicylic acid LIQUID TOPICAL 20160803 OTC MONOGRAPH FINAL part333D DOLGENCORP, LLC SALICYLIC ACID 18 mg/mL N 20181231 55910-105_588c0262-7511-d9be-e053-2991aa0aa2e6 55910-105 HUMAN OTC DRUG Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazel witch hazel CLOTH TOPICAL 20120101 OTC MONOGRAPH FINAL part346 Dolgencorp, LLC WITCH HAZEL 129 g/258g N 20181231 55910-106_e38f6e47-f322-49c1-85b3-85faf6b7c6a3 55910-106 HUMAN OTC DRUG DG Health Fast Acting Mucus Relief Severe Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20150921 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55910-108_bfee9557-c601-4a42-8ed5-3d04e37749ed 55910-108 HUMAN OTC DRUG DG Health Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20151211 OTC MONOGRAPH FINAL part331 Dolgencorp, LLC CALCIUM CARBONATE 750 mg/1 N 20181231 55910-110_180667e6-82d8-4fc1-b91e-3687ae017098 55910-110 HUMAN OTC DRUG Rexall Feminine Povidone-iodine KIT 20101019 OTC MONOGRAPH NOT FINAL part333A Dolgencorp Inc E 20171231 55910-114_c259c68d-284e-46c7-8d8a-78848d0c6bcd 55910-114 HUMAN OTC DRUG Night Time Sleep Aid Diphenhydramine HCl LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 55910-117_97e46456-e176-4a40-82fa-aa2592c39fc9 55910-117 HUMAN OTC DRUG dg health lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120521 ANDA ANDA202319 Dolgencorp, LLC LANSOPRAZOLE 15 mg/1 N 20181231 55910-120_bb75dff9-e5bb-4e17-ad70-dbc00ffbe691 55910-120 HUMAN OTC DRUG womans laxative Bisacodyl TABLET, COATED ORAL 20130621 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) BISACODYL 5 mg/1 N 20181231 55910-121_a451f9b9-7498-4243-a49c-dbcff6ef9875 55910-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120517 ANDA ANDA078682 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) IBUPROFEN 200 mg/1 E 20171231 55910-129_78ca094b-5b13-4ab8-b3d4-293e5975f74a 55910-129 HUMAN OTC DRUG Allergy Relief All Day Cetirizine HCl TABLET ORAL 20130517 ANDA ANDA078780 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55910-133_1b170358-ffd1-4c9e-8d75-a082e05219eb 55910-133 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20120514 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, LLC MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 55910-134_8555a220-865e-4ca0-87ad-3d7c8cf3b3af 55910-134 HUMAN OTC DRUG Back and Body Extra Strength Aspirin, Caffeine TABLET, FILM COATED ORAL 20040412 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 N 20181231 55910-136_8f33805d-2163-4351-ba08-ca0b82051fbb 55910-136 HUMAN OTC DRUG Peptic Relief Cherry Bismuth Subsalicylate SUSPENSION ORAL 20090107 OTC MONOGRAPH FINAL part335 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 55910-139_456ad45f-5021-46fe-94c9-60dea9182eac 55910-139 HUMAN OTC DRUG DG Health Cold and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20100226 OTC MONOGRAPH FINAL part341 Dolgencorp Inc CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 55910-140_0b4becda-1cc1-49f5-b7b0-9844a09fbeb6 55910-140 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20130430 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) SENNOSIDES 25 mg/1 N 20181231 55910-141_4a204604-3223-4112-b3ff-24a7d9887406 55910-141 HUMAN OTC DRUG dg health heartburn prevention original strength Famotidine TABLET ORAL 20100310 ANDA ANDA075400 Dolgencorp, LLC FAMOTIDINE 10 mg/1 N 20181231 55910-143_d4141700-86c6-4571-9663-0271ee1ca8aa 55910-143 HUMAN OTC DRUG DG Health Mucus Relief Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20130726 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 55910-148_f12aaa78-0b09-43bd-8def-f07ef553886f 55910-148 HUMAN OTC DRUG Diaper Rash Zinc oxide CREAM TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part347 DolGenCorp, LLC ZINC OXIDE .113 kg/g N 20181231 55910-150_05fc45d5-5a75-4534-91b5-78b5bf71e4d9 55910-150 HUMAN OTC DRUG Stool Softener Maximum Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130430 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DOCUSATE SODIUM 250 mg/1 N 20181231 55910-151_e1523ba4-2dc5-4c2b-918f-50e553f34289 55910-151 HUMAN OTC DRUG DG Health Sleep Aid Diphenhydramine Hydrochloride TABLET ORAL 20091204 OTC MONOGRAPH FINAL part338 Dolgencorp Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55910-153_d361cb4f-9f35-4c45-bc41-b62936e42bd9 55910-153 HUMAN OTC DRUG Simply Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Dolgencorp, LLC PYRITHIONE ZINC 1 mg/mL N 20191231 55910-154_939b1d46-0112-4950-bb32-4bc6019cd720 55910-154 HUMAN OTC DRUG Flu Relief Therapy Night Time Theraflu Nighttime LIQUID ORAL 20130726 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 55910-159_f4c17773-9506-488c-96c8-f4e566efead9 55910-159 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55910-160_6be1896d-f247-48d0-8a2f-f9b0d8e4a36e 55910-160 HUMAN OTC DRUG rexall hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20121004 OTC MONOGRAPH FINAL part346 Dolgencorp, LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g N 20181231 55910-161_98621ce4-89d6-4dcd-9cdc-3a8c7af4a675 55910-161 HUMAN OTC DRUG dg health infants pain and fever Acetaminophen SUSPENSION ORAL 20120503 OTC MONOGRAPH NOT FINAL part343 Dolgencorp Inc ACETAMINOPHEN 160 mg/5mL N 20181231 55910-163_d1af6c1c-799b-44b1-85b9-55546d355a21 55910-163 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20060513 OTC MONOGRAPH FINAL part355 Dolgencorp, LLC SODIUM FLUORIDE .1 mg/mL N 20181231 55910-165_5f2bbd65-fb9b-418d-9211-99e3077368c9 55910-165 HUMAN OTC DRUG Rexall All Day Pain Relief Naproxen sodium TABLET, FILM COATED ORAL 20130731 ANDA ANDA074661 Dolgencorp, LLC NAPROXEN SODIUM 220 mg/1 N 20181231 55910-166_c721d563-5296-4fda-93c7-5d2e29592316 55910-166 HUMAN OTC DRUG DG Health childrens ibuprofen Ibuprofen SUSPENSION ORAL 20160502 ANDA ANDA074937 Dolgencorp, LLC IBUPROFEN 100 mg/5mL N 20181231 55910-167_3309bb0b-f814-4a71-97dc-98cab0c1eb27 55910-167 HUMAN OTC DRUG rexall daytime nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120914 OTC MONOGRAPH FINAL part341 Dolgencorp Inc N 20181231 55910-171_c28589fd-28cf-4d14-bbfc-9f585eb4fb75 55910-171 HUMAN OTC DRUG Antiseptic Oral Cleanser Hydrogern Peroxide MOUTHWASH ORAL 20090419 OTC MONOGRAPH NOT FINAL part356 DOLGENCORP, LLC HYDROGEN PEROXIDE 150 mg/100L N 20181231 55910-179_a8cb15b9-f6a9-4b0d-a286-41e15e351b7f 55910-179 HUMAN OTC DRUG Creamy Petroleum White petrolatum JELLY TOPICAL 20090105 OTC MONOGRAPH FINAL part347 Dollar General PETROLATUM .3 g/100g N 20181231 55910-180_c0787d41-c53e-4308-bd16-1b3828a42532 55910-180 HUMAN OTC DRUG Healing for Babies Petrolatum OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part347 DOLGENCORP, LLC PETROLATUM 410 mg/g N 20181231 55910-181_46b30ec2-6b41-49e8-a50c-b3d97dfdde31 55910-181 HUMAN OTC DRUG Senna Laxative Natural vegetable laxative Sennosides TABLET ORAL 20100707 OTC MONOGRAPH NOT FINAL part334 Dolgencorp Inc SENNOSIDES 8.6 mg/1 N 20181231 55910-184_a0ef2e8e-bdbc-4fbe-8515-73ce5f7b19e4 55910-184 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20130708 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55910-185_1696c10c-25a1-4ea3-bdfb-374e53f0f12d 55910-185 HUMAN OTC DRUG BENZOCAINE and RESORCINOL BENZOCAINE and RESORCINOL CREAM TOPICAL 20090519 OTC MONOGRAPH NOT FINAL part348 Dolgencorp, inc BENZOCAINE; RESORCINOL 200; 20 mg/g; mg/g E 20171231 55910-186_8a9909aa-d53b-4d63-9c07-f8deccd7da27 55910-186 HUMAN OTC DRUG dg health sleep aid Diphenhydramine HCl SOLUTION ORAL 20150511 OTC MONOGRAPH FINAL part338 Dolgencorp, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 55910-188_94daa0bd-aefd-4361-906c-63b07f24ad42 55910-188 HUMAN OTC DRUG DG Health Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131220 OTC MONOGRAPH FINAL part346 Dolgencorp, LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 55910-190_3f6f3ad5-2add-411a-acca-f04b03878322 55910-190 HUMAN OTC DRUG Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20130620 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) BISACODYL 5 mg/1 N 20181231 55910-194_61ec44d7-3dc2-4ae2-8075-30173afcafaf 55910-194 HUMAN OTC DRUG dg health heartburn prevention Famotidine TABLET ORAL 20100214 ANDA ANDA077351 Dolgencorp Inc FAMOTIDINE 20 mg/1 N 20181231 55910-198_31481304-8cdb-4cc5-a494-7db43b84f18b 55910-198 HUMAN OTC DRUG Dollar General Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Dollar General SODIUM FLUORIDE .243 g/100g N 20181231 55910-199_a3f6d500-d44a-43d8-84e6-57909b2786f8 55910-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100707 ANDA ANDA078682 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) IBUPROFEN 200 mg/1 E 20171231 55910-200_75664364-e16f-43c7-90a5-00aabad45382 55910-200 HUMAN OTC DRUG dg health pain relief childrens Acetaminophen SUSPENSION ORAL 20091128 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 55910-202_5c8bde5a-5900-085f-e053-2991aa0a56af 55910-202 HUMAN OTC DRUG Body Bar Gold Benzalkonium Chloride SOAP CUTANEOUS 20171027 OTC MONOGRAPH NOT FINAL part333E Dolgencorp, LLC BENZALKONIUM CHLORIDE .1 g/100g N 20181231 55910-203_2b6963ae-669c-40be-aafd-6fef73d3a5a3 55910-203 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20000424 OTC MONOGRAPH NOT FINAL part333A Dolgencorp, LLC ALCOHOL .65 mL/100L N 20181231 55910-205_3b3a8297-c42f-4f60-ac5e-1681f78e9bda 55910-205 HUMAN OTC DRUG Nite Time Sleep Aid LiquidGels Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130411 OTC MONOGRAPH FINAL part338 Dolgencorp, Inc. (DOLLAR GENERAL) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55910-209_41b7c198-7d0c-437e-9686-821c4b57ba39 55910-209 HUMAN OTC DRUG DG Health Triple Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20150623 OTC MONOGRAPH FINAL part333B Dolgencorp, LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 55910-211_83ea010b-ba06-4620-a0c3-0c4dfbcf75b5 55910-211 HUMAN OTC DRUG Isopropyl ISOPROPYL ALCOHOL SOLUTION TOPICAL 20040811 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP, LLC ISOPROPYL ALCOHOL 462 mg/mL N 20191231 55910-212_50480a28-2dbf-4955-8ca5-a7e1acea3db2 55910-212 HUMAN OTC DRUG DG Health Antacid calcium carbonate TABLET, CHEWABLE ORAL 20151201 OTC MONOGRAPH FINAL part331 Dolgencorp, LLC CALCIUM CARBONATE 500 mg/1 N 20181231 55910-213_93e5144f-a576-46d9-b066-c5f287f12c78 55910-213 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20070819 OTC MONOGRAPH FINAL part355 DOLGENCORP,LLC SODIUM FLUORIDE .05 kg/100L N 20181231 55910-217_ed17740d-77a4-4f39-879c-f32f1291b0cc 55910-217 HUMAN OTC DRUG Dg Health pain reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100105 ANDA ANDA075077 Dolgencorp, LLC ACETAMINOPHEN 650 mg/1 N 20181231 55910-218_ecf4b4db-74f4-48be-8e6a-92d5345a21f2 55910-218 HUMAN OTC DRUG Clear Anti-Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 20110630 OTC MONOGRAPH NOT FINAL part347 DOLGENCORP, LLC PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 55910-219_bd8c0b27-ecd9-462a-8cff-4505069d459b 55910-219 HUMAN OTC DRUG dg health anti diarrheal loperamide HCl SUSPENSION ORAL 20151119 ANDA ANDA091292 Dolgencorp, LLC LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 55910-220_7f2c16bd-b13a-4b7f-9772-5e963daf416d 55910-220 HUMAN OTC DRUG All Day Allergy Relief 24 HOUR Cetirizine HCl TABLET ORAL 20121019 ANDA ANDA078427 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55910-221_e53af5e8-8694-4f5f-8ab1-06d90a3c4f16 55910-221 HUMAN OTC DRUG Allergy Relief All Day Cetirizine HCl TABLET ORAL 20130517 ANDA ANDA078427 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55910-224_5ca2a2fc-1689-4021-ab2c-d6341de404fa 55910-224 HUMAN OTC DRUG dg health anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20091228 ANDA ANDA075232 Dolgencorp, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 55910-225_bc8a5d5a-bbfe-4cb3-abd8-d262d041ea76 55910-225 HUMAN OTC DRUG rexall anti itch maximum strength relief Hydrocortisone CREAM TOPICAL 20100831 OTC MONOGRAPH NOT FINAL part348 Dolgencorp, LLC HYDROCORTISONE 1 g/100g N 20181231 55910-226_791ef58c-032c-46a9-91f2-603ea342f5de 55910-226 HUMAN OTC DRUG Alert Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 DOLGENCORP, LLC CAFFEINE 200 mg/1 N 20181231 55910-227_dd9f42ab-30b9-4c1e-8dee-aa3c3e245ed2 55910-227 HUMAN OTC DRUG DG Health Pain Reliever Acetaminophen TABLET, COATED ORAL 20100221 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 500 mg/1 N 20181231 55910-230_36732bfe-9847-4728-9ef6-062b11c970c5 55910-230 HUMAN OTC DRUG DG Health Maximum Strength Sleep Aid DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20121129 OTC MONOGRAPH FINAL part338 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 55910-232_56680049-9670-4adb-9b2a-7e14624f0155 55910-232 HUMAN OTC DRUG Mucus Relief DM Max Maximum Strength Mucinex DM Max Maximum Strength LIQUID ORAL 20130101 20181031 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/20mL; mg/20mL N 20181231 55910-235_9073c2fb-0f84-44bd-83ce-b6d75b4e05d5 55910-235 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20110126 OTC MONOGRAPH FINAL part347 DOLGENCORP LLC PETROLATUM 838 g/g N 20191231 55910-236_e279d335-b52a-4ee7-b943-8f1ac3154fc3 55910-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 55910-238_f021a6b6-82c5-4ab7-a7b5-b0730374a1de 55910-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130830 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DOCUSATE SODIUM 100 mg/1 N 20181231 55910-240_b9de8131-bf2f-4bab-a3aa-bbaf8603ad32 55910-240 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 55910-242_02ce3db9-54d1-4efa-904b-7adccc9dde30 55910-242 HUMAN OTC DRUG EZ Nite Sleep ZzzQuil LIQUID ORAL 20130101 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 55910-244_74c2e513-2185-4f12-ba3e-cdf9363acec7 55910-244 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DOCUSATE SODIUM 100 mg/1 E 20171231 55910-245_d27762e5-ad85-4915-aa7d-5948daad04de 55910-245 HUMAN OTC DRUG Laxative pills Maximum Strength Sennosides TABLET ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) SENNOSIDES 25 mg/1 N 20181231 55910-246_6f2f7b7f-d98f-42a3-ba19-e7a9f4ab8ed7 55910-246 HUMAN OTC DRUG Medicated Dandruff Selenium sulfide SHAMPOO TOPICAL 20111103 OTC MONOGRAPH FINAL part358H Dolgencorp.LLC SELENIUM SULFIDE 1 kg/100L N 20181231 55910-247_e3d3b811-8bd3-4a0e-a8d0-2e72aea4f17f 55910-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140131 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55910-248_2ab8a4ee-8a80-4442-8d33-7d637903939c 55910-248 HUMAN OTC DRUG Medicated Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20100907 OTC MONOGRAPH FINAL part341 Doldgecorp, LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg N 20181231 55910-249_20763071-0586-4ada-a6ad-cecf8dca2579 55910-249 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ASPIRIN 325 mg/1 N 20181231 55910-251_5a588f82-8fa7-4204-aca5-6a5c85f52650 55910-251 HUMAN OTC DRUG DG Health Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20150520 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 55910-255_8a1dca5e-ce06-4493-8687-09c172daf8dc 55910-255 HUMAN OTC DRUG dg health ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20100427 ANDA ANDA075217 Dolgencorp, LLC IBUPROFEN 50 mg/1.25mL N 20181231 55910-258_4a431d89-985c-4e9c-b56b-666cdd5180e9 55910-258 HUMAN OTC DRUG Stool Softener Maximum Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140630 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DOCUSATE SODIUM 250 mg/1 N 20181231 55910-263_c8434ba7-775a-46c0-aca7-d09ac2149bd4 55910-263 HUMAN OTC DRUG DG Health Antacid calcium carbonate TABLET, CHEWABLE ORAL 20170425 OTC MONOGRAPH FINAL part331 Dolgencorp, LLC CALCIUM CARBONATE 750 mg/1 N 20181231 55910-264_c28f3e61-685b-48c6-bce6-e2ff046869d3 55910-264 HUMAN OTC DRUG Acne Cleanser Benzoyl peroxide CREAM TOPICAL 20140218 OTC MONOGRAPH FINAL part333D DOLGENCORP, LLC BENZOYL PEROXIDE 104 mg/10g N 20181231 55910-274_4c2e2c79-8c9d-4a9c-b7ef-412aa19834fb 55910-274 HUMAN OTC DRUG rexall aspirin Aspirin TABLET, CHEWABLE ORAL 20100819 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ASPIRIN 81 mg/1 N 20181231 55910-276_fb7abc65-55a4-418e-97c2-708776aeb86d 55910-276 HUMAN OTC DRUG DG Health Sinus PE Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20150804 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 55910-278_6c7b6834-1609-4d9c-a527-d225879174c5 55910-278 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333A Dolgencorp, LLC BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 55910-279_da871945-34e7-4939-a56f-d58efba55d95 55910-279 HUMAN OTC DRUG rexall hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140828 OTC MONOGRAPH FINAL part346 Dolgencorp Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 55910-282_47c11f28-0323-4eb8-a6d1-62a3ae207e31 55910-282 HUMAN OTC DRUG Pain Relief Childrens Acetaminophen SUSPENSION ORAL 20150430 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN 160 mg/5mL N 20181231 55910-284_20a67ffb-601a-417b-a0ea-16132abfdc92 55910-284 HUMAN OTC DRUG DG Health Tussin Acetaminophen, diphenhydramine HCl, phenylephrine HCl SOLUTION ORAL 20160801 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 55910-294_0ff7ddfc-489b-46f7-a457-aa348dfa1bf2 55910-294 HUMAN OTC DRUG DG BODY ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC. TRICLOSAN .15 mL/100mL N 20181231 55910-294_173f5bf7-2c20-4dc6-96c7-7cf319b89451 55910-294 HUMAN OTC DRUG DG BODY ANTIBACTERIAL HAND TRICLOSAN SOAP TOPICAL 20150826 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC TRICLOSAN 1.5 mg/mL N 20181231 55910-294_18ae8a02-53c9-45c1-b9c7-599afb6ce9e5 55910-294 HUMAN OTC DRUG DG BODY ANTIBACTERIAL HAND TRICLOSAN SOAP TOPICAL 20150616 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC TRICLOSAN 1.5 mg/mL N 20181231 55910-294_e09edddf-1b0b-45cc-88e9-4016fc85318f 55910-294 HUMAN OTC DRUG DG BODY ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC. TRICLOSAN .15 mL/100mL N 20181231 55910-295_6b74a916-9436-4172-ab88-7c24d5896b59 55910-295 HUMAN OTC DRUG Itch Relief Diphenhydramine HCl, Zinc Acetate SPRAY TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP, LLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 18; 882 mg/mL; mg/mL N 20181231 55910-296_546712dc-832a-4924-b35a-552d0a8008a5 55910-296 HUMAN OTC DRUG DG BODY ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC. TRICLOSAN .15 mL/100mL N 20181231 55910-296_f1098463-11da-43b4-8c48-da246cfad9ad 55910-296 HUMAN OTC DRUG DG BODY ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120504 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC. TRICLOSAN .15 mL/100mL N 20181231 55910-297_75e49c58-5a97-42bf-8e9d-29c43a4f1bc5 55910-297 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide SUSPENSION ORAL 20150831 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 55910-298_c02540a1-6a60-45ff-a8f5-58c4d5ef6024 55910-298 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide SUSPENSION ORAL 20150731 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 55910-299_ea7ba967-6b46-4318-b627-dafdd1eb26f1 55910-299 HUMAN OTC DRUG Health Cetylpyridinium chloride MOUTHWASH ORAL 20080721 OTC MONOGRAPH NOT FINAL part356 DOLGENCORP, LLC CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 55910-300_a5d21611-b880-4f1d-ab73-b6e5ec345cf8 55910-300 HUMAN OTC DRUG DG Health Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140327 OTC MONOGRAPH FINAL part341 Dolgencorp Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 55910-301_d9108290-ebb9-455b-add3-78489380978a 55910-301 HUMAN OTC DRUG Dollar General Gold Triclocarban SOAP TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E Dolgencorp, LLC TRICLOCARBAN .6 g/100g E 20171231 55910-302_1f27f251-04b7-4d30-8595-d4d0300c150b 55910-302 HUMAN OTC DRUG DG health childrens pain relief Acetaminophen SUSPENSION ORAL 20120909 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 55910-303_c93a351d-d6be-4063-837b-f379f6a4bf6f 55910-303 HUMAN OTC DRUG Childrens Plus Multi Symptom Cold DYE FREE Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 55910-304_2093d0f1-91c3-4364-91a4-b830b480d37f 55910-304 HUMAN OTC DRUG dg health nasal original oxymetazoline hydrochloride SPRAY NASAL 20100108 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 55910-305_77803f1a-ff2b-41f2-9a10-b212eb6d4b2d 55910-305 HUMAN OTC DRUG DG HEALTH ANTI ITCH DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP, INC. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 55910-306_3425ff81-de3b-43c3-9564-be0a31e8933b 55910-306 HUMAN OTC DRUG dg health clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 Dolgencorp, LLC POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 55910-308_a62a92eb-090b-42eb-812c-00d5c36cfd2f 55910-308 HUMAN OTC DRUG DG Health cold multi symptom severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20091128 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55910-309_d24dbe2a-dde4-4957-96a4-6905102157de 55910-309 HUMAN OTC DRUG Cough Relief Adult Dextromethorphan HBr LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 55910-310_c84dd981-5d1a-41c7-8068-4a41d890ed3a 55910-310 HUMAN OTC DRUG DG Health Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20150723 ANDA ANDA078912 Dolgencorp Inc GUAIFENESIN 600 mg/1 N 20181231 55910-311_caf78999-3aba-4475-8895-3084005a1ab9 55910-311 HUMAN OTC DRUG 2 in 1 Dandruff Pyrithione zinc SHAMPOO TOPICAL 20050623 OTC MONOGRAPH FINAL part358H Dolgencorp, LLC PYRITHIONE ZINC 10 mg/mL N 20181231 55910-312_60a2def9-73ee-024c-e053-2a91aa0a0331 55910-312 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20150513 OTC MONOGRAPH FINAL part358B Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) SALICYLIC ACID .17 mg/9.8mL N 20181231 55910-316_6f40df2a-edd8-4fd9-ba17-d568daf32d45 55910-316 HUMAN OTC DRUG REXALL PETROLEUM WITH VITAMIN E AND ALOE PETROLATUM JELLY TOPICAL 20150303 OTC MONOGRAPH FINAL part347 DOLGENCORP INC PETROLATUM 99.8 g/100g N 20181231 55910-317_08ce697e-17f4-46b5-a1ac-efa053da815f 55910-317 HUMAN OTC DRUG DG BODY PETROLEUM COCOA BUTTER PETROLATUM JELLY TOPICAL 20150226 OTC MONOGRAPH FINAL part346 DOLGENCORP INC PETROLATUM 99.8 g/100g N 20181231 55910-317_cdf7465d-2f82-412f-8dd8-6ae1269ff36a 55910-317 HUMAN OTC DRUG DG BODY PETROLEUM COCOA BUTTER PETROLATUM JELLY TOPICAL 20150809 OTC MONOGRAPH FINAL part346 DOLGENCORP INC PETROLATUM 99.8 g/100g N 20181231 55910-318_495568bc-ce52-4667-9e00-be81a15c3ff8 55910-318 HUMAN OTC DRUG Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 20010111 OTC MONOGRAPH NOT FINAL part356 DOLGENCORP,LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55910-319_f454a28e-31c9-4104-af76-cc5f96a0ed1a 55910-319 HUMAN OTC DRUG DG Health Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20100130 OTC MONOGRAPH NOT FINAL part348 Dolgencorp Inc HYDROCORTISONE 1 g/100g N 20181231 55910-320_05ba2419-a27d-477a-9da5-5538347ed41f 55910-320 HUMAN OTC DRUG Dollar General Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 Dolgencorp LLC SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 55910-321_03ed5a79-e78c-44b9-b888-d1f89dde79fb 55910-321 HUMAN OTC DRUG DG Health Dual Action Complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20090716 ANDA ANDA077355 Dolgencorp Inc FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 55910-322_68d35ef6-1c86-4873-a863-7ad7557548f2 55910-322 HUMAN OTC DRUG Dollar General Toothache Relief Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B Dollar General BENZOCAINE 20 g/100g N 20181231 55910-326_44ff5186-3c4e-400c-be42-2f89d78d7654 55910-326 HUMAN OTC DRUG Daily Facial Moisturizer Broad Spectrum SPF15 Sunscreen Avobenzone, Octocrylene CREAM TOPICAL 20130720 OTC MONOGRAPH NOT FINAL part352 Dolgencorp Inc. AVOBENZONE; OCTOCRYLENE 3; 10 g/100mL; g/100mL N 20181231 55910-327_07ce6e24-ad66-4eee-941d-b50e397d6cf6 55910-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET, SUGAR COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 DOLGENCORP, LLC BISACODYL 5 mg/1 N 20181231 55910-329_ca7e3b9d-4c5e-475c-885f-30b6c811ee37 55910-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, FILM COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55910-333_38433e43-3cb3-4e43-a1d1-b0da2cf463db 55910-333 HUMAN OTC DRUG Ultimate Daily Face Wash Salicylic Acid CREAM TOPICAL 20130720 OTC MONOGRAPH FINAL part333D Dolgencorp Inc. SALICYLIC ACID 2 g/100mL N 20181231 55910-334_dbb6ba09-532d-4f11-9809-b7b425fbac45 55910-334 HUMAN OTC DRUG DG BABY DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 DOLGENCORP INC ZINC OXIDE 40 g/100g N 20181231 55910-335_45f22571-aab6-43f9-9158-6e3d5255c22e 55910-335 HUMAN OTC DRUG dg health night time cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110817 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 55910-336_e3b16bd5-672d-4fe1-90dd-424ac3901be8 55910-336 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 55910-337_dbba868d-4df7-4152-8492-4055a847aaa1 55910-337 HUMAN OTC DRUG rexall bismuth Bismuth subsalicylate SUSPENSION ORAL 20120906 OTC MONOGRAPH FINAL part335 Dolgencorp, LLC BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 55910-338_aa7c4d70-ce18-40bd-8f45-1bb490016922 55910-338 HUMAN OTC DRUG Mucus Relief DM Max Maximum Strength Fast Acting Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 55910-339_c1d634e7-eed9-407c-94d5-61c3d52b557c 55910-339 HUMAN OTC DRUG Saline Laxative Cherry Laxative Sodium Phosphate, Dibasic and Sodium Phosphate, Monobasic, Unspecified Form LIQUID ORAL 20160315 OTC MONOGRAPH NOT FINAL part334 Dolgencorp Inc. SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 2.7; 7.2 g/45mL; g/45mL N 20181231 55910-340_43052995-86f8-4384-9b8d-23e7a49e0344 55910-340 HUMAN OTC DRUG Rexall Athletes Foot Clotrimazole CREAM TOPICAL 20171001 OTC MONOGRAPH FINAL part333C Dollar General CLOTRIMAZOLE .01 mg/10g N 20181231 55910-341_2ea60293-4e61-4116-a0e7-f1e4ecea770f 55910-341 HUMAN OTC DRUG Athletes Foot Antifungal TOLNAFTATE CREAM TOPICAL 20171001 OTC MONOGRAPH FINAL part333C Dollar General TOLNAFTATE .01 mg/10g N 20181231 55910-343_f029e972-d013-468d-9e9e-e0f5e16a8182 55910-343 HUMAN OTC DRUG Rexall Jock Itch Clotrimazole CREAM TOPICAL 20171001 OTC MONOGRAPH FINAL part333C Dollar General CLOTRIMAZOLE .01 mg/10g N 20181231 55910-344_55fc73e9-6a0f-4592-999e-19bed72bd9d3 55910-344 HUMAN OTC DRUG DG Anti-Itch Diphenhydramine hydrochloride and Zinc acetate CREAM TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part348 Dollar General DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; .1 mg/g; mg/g N 20181231 55910-346_32007ff7-11a4-4029-bf35-df84e9ba896e 55910-346 HUMAN OTC DRUG Rexall Maximum Strength Benzocaine LIQUID DENTAL 20150101 OTC MONOGRAPH FINAL part333B Rexall BENZOCAINE 20 g/100g N 20181231 55910-348_5b42ef6e-a5eb-4d83-b529-121a52d9212b 55910-348 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET ORAL 20030102 OTC MONOGRAPH NOT FINAL part334 DOLGENCORP, LLC SENNOSIDES 25 mg/1 N 20181231 55910-350_95b3eed8-a99f-430c-bd08-58a517025303 55910-350 HUMAN OTC DRUG DG BODY PETROLEUM PETROLATUM JELLY TOPICAL 20150302 OTC MONOGRAPH FINAL part347 DOLGENCORP INC PETROLATUM 100 g/100g N 20181231 55910-350_af5289cf-9d29-408d-b16f-a1eaa239527f 55910-350 HUMAN OTC DRUG DG BODY PETROLEUM PETROLATUM JELLY TOPICAL 20150701 OTC MONOGRAPH FINAL part347 DOLGENCORP INC PETROLATUM 100 g/100g N 20181231 55910-351_a4a61d65-bd03-4568-83c8-2412528518bc 55910-351 HUMAN OTC DRUG DG BABY PETROLEUM PETROLATUM JELLY TOPICAL 20150818 OTC MONOGRAPH FINAL part347 DOLGENCORP INC PETROLATUM 100 g/100g N 20181231 55910-354_a4d6f59e-7d8a-4c29-bcaa-fb228979eb3f 55910-354 HUMAN OTC DRUG Daily Baby Dimethicone LOTION TOPICAL 20150810 OTC MONOGRAPH FINAL part347 DOLGENCORP LLC DIMETHICONE 13.1 mg/g N 20181231 55910-355_83960b8a-e674-447b-943f-ed885970ac8d 55910-355 HUMAN OTC DRUG dg health headache relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20100214 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55910-357_6c71aefc-dd91-4863-b79d-573d1776988c 55910-357 HUMAN OTC DRUG dg health antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20140509 OTC MONOGRAPH FINAL part331 Dolgencorp, LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 55910-359_79ab70d4-8279-4781-bc81-0911097292f3 55910-359 HUMAN OTC DRUG dg health tussin dm adult Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 20100222 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 55910-368_015c85ae-db15-426d-b08b-6cd72ce4cb07 55910-368 HUMAN OTC DRUG dg health all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20100117 ANDA ANDA074661 Dolgencorp Inc NAPROXEN SODIUM 220 mg/1 N 20181231 55910-369_2a8d9e37-4906-4e08-9152-ea442e87c488 55910-369 HUMAN OTC DRUG Menstrual Pain Relief Acetaminophen, Pamabrom and Pyrilamine maleate TABLET, FILM COATED ORAL 20000620 20181101 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 E 20171231 55910-370_97c58fb9-e476-4637-b851-33363ea3b51c 55910-370 HUMAN OTC DRUG dg health mucus relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140724 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55910-371_6a21cbc8-6a50-4f7a-a25c-9e1e6e2d25bd 55910-371 HUMAN OTC DRUG rexall all day pain relief Naproxen Sodium TABLET, FILM COATED ORAL 20120928 ANDA ANDA074661 Dolgencorp Inc NAPROXEN SODIUM 220 mg/1 N 20181231 55910-372_f5cbc392-f1ce-44cd-ac9f-2483dbc3acc6 55910-372 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part335 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 55910-374_38785968-d07f-41fc-ac1c-7adc0a7fcf53 55910-374 HUMAN OTC DRUG DG Health migraine relief Acetaminophen, Aspirin, Caffeine TABLET, COATED ORAL 20091204 ANDA ANDA075794 Dolgencorp, LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 55910-377_93c7ccf0-ad2c-45b1-b7b6-07d58712970c 55910-377 HUMAN OTC DRUG rexall anti diarrheal Loperamide HCl SOLUTION ORAL 20100809 ANDA ANDA073243 Dolgencorp, LLC LOPERAMIDE HYDROCHLORIDE 1 mg/5mL N 20181231 55910-378_b272f521-5cfc-4ee1-9862-ed652c9dab93 55910-378 HUMAN OTC DRUG Triacting Daytime Cold Cough Childrens Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20140530 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 55910-379_0cd8f457-02f3-4a72-87c0-0701a1558b88 55910-379 HUMAN OTC DRUG dg health allergy childrens Diphenhydramine Hydrochloride SOLUTION ORAL 20100129 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 55910-381_dd719dcd-e19a-44b5-81e5-5bcf5206c9d1 55910-381 HUMAN OTC DRUG DG Health Mucus Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130726 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55910-384_4043e766-d4f6-4856-9117-fc7e5a77b45f 55910-384 HUMAN OTC DRUG DG Health Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130702 ANDA ANDA091135 Dolgencorp, LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 55910-388_7fd88550-81f3-4c6d-b6c0-806d2ebb3f4f 55910-388 HUMAN OTC DRUG DG Health Antacid Calcium Supplement Calcium carbonate TABLET, CHEWABLE ORAL 20131210 OTC MONOGRAPH FINAL part331 Dolgencorp, LLC CALCIUM CARBONATE 750 mg/1 N 20181231 55910-390_b5695e22-5ae9-409b-8688-82b03053170c 55910-390 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET, FILM COATED ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 55910-391_784b4164-3b17-4e56-bb4e-e872c5fde188 55910-391 HUMAN OTC DRUG DG HEALTH EXTRA STRENGTH MEDICATED MENTHOL PATCH TOPICAL 20121231 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP INC MENTHOL 750 mg/1 N 20181231 55910-392_4a0deb5d-8961-c8c8-2274-eb622422f259 55910-392 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990302 ANDA ANDA075139 DOLGENCORP, LLC IBUPROFEN 200 mg/1 N 20181231 55910-394_ed78930c-d910-4d07-a88d-de1071d718b6 55910-394 HUMAN OTC DRUG rexall hemorrhoidal Cocoa butter, Phenylephrine HCl, Shark liver oil SUPPOSITORY RECTAL 20110524 OTC MONOGRAPH FINAL part346 Dolgencorp, LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 2137.5; 75; 6.375 mg/1; mg/1; mg/1 N 20181231 55910-395_3fc75f5b-e4fb-4041-b665-9415ffcd626f 55910-395 HUMAN OTC DRUG DG Health Extra Strength Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Dolgencorp Inc MENTHOL 750 mg/1 N 20181231 55910-396_9ae592ee-78af-47d2-ad1d-b2c0477cbc9e 55910-396 HUMAN OTC DRUG dg health milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20140507 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 55910-397_0fa38747-74a1-419f-bdfc-311b2bb81fb2 55910-397 HUMAN OTC DRUG dg health antacid calcium supplement regular strength calcium carbonate TABLET, CHEWABLE ORAL 20091121 OTC MONOGRAPH FINAL part331 Dolgencorp Inc CALCIUM CARBONATE 500 mg/1 N 20181231 55910-402_600fd5a6-bacf-4d4d-b6da-8a1bdca490c0 55910-402 HUMAN OTC DRUG Rexall Maximum Strength Hemorrhoidal PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM CREAM TOPICAL 20110628 OTC MONOGRAPH FINAL part346 Dolgencorp, Inc. PRAMOXINE HYDROCHLORIDE; GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 10; 144; 150; 2.5 mg/g; mg/g; mg/g; mg/g E 20171231 55910-404_60b49ba0-e72f-f423-e053-2a91aa0aeb3c 55910-404 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20150629 OTC MONOGRAPH FINAL part358F Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) SALICYLIC ACID .17 g/9mL N 20181231 55910-405_36a96992-0a5d-1323-e054-00144ff88e88 55910-405 HUMAN OTC DRUG Cool Heat Menthol and Methyl Salicylate CREAM TOPICAL 20160629 OTC MONOGRAPH NOT FINAL part348 Dolgencorp Inc MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 55910-406_36a96992-0a52-1323-e054-00144ff88e88 55910-406 HUMAN OTC DRUG Rexall Maximum Strength Hemorrhoidal GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE CREAM TOPICAL 20160629 OTC MONOGRAPH FINAL part346 Dolgencorp, Inc. GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g N 20181231 55910-407_36a97165-e026-65cf-e054-00144ff88e88 55910-407 HUMAN OTC DRUG Anti-Itch Menthol and Pramoxine Hydrochloride CREAM TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part348 Dolgencorp, Inc. MENTHOL; PRAMOXINE HYDROCHLORIDE 1; 1 g/100g; g/100g N 20181231 55910-408_ece05852-929f-4607-8926-0dd4d0ebf559 55910-408 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20160229 ANDA ANDA078682 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) IBUPROFEN 200 mg/1 N 20181231 55910-409_60a2d70f-9f1c-f13c-e053-2a91aa0a4c2a 55910-409 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20130513 OTC MONOGRAPH FINAL part358F Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) SALICYLIC ACID 40 mg/91 N 20181231 55910-410_60a06c26-c256-fddc-e053-2a91aa0a4d95 55910-410 HUMAN OTC DRUG Undecylenic Acid Anti-Fungal Nail Solution LIQUID TOPICAL 20140227 OTC MONOGRAPH FINAL part333C Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) UNDECYLENIC ACID 7.5 g/30mL N 20181231 55910-411_3b0f9aad-816e-44dc-8df4-a0db09347748 55910-411 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr TABLET, SUGAR COATED ORAL 20030503 20190428 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20191231 55910-412_e490ddc4-28a6-42a0-b79b-c18b44bf542e 55910-412 HUMAN OTC DRUG Miconazole Nitrate Jock Itch Spray AEROSOL, SPRAY TOPICAL 20130513 OTC MONOGRAPH FINAL part333C Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) MICONAZOLE NITRATE 1.3 g/131g N 20181231 55910-413_269bac38-09d2-4d81-92f6-e7db45b6308b 55910-413 HUMAN OTC DRUG DG Health Ibuprofen PM Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20100817 ANDA ANDA079113 Dolgencorp, LLC DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 55910-414_0ed0e7f2-3cf5-4c77-b5b9-d18c886082a4 55910-414 HUMAN OTC DRUG Adult Low Strength Aspirin Aspirin TABLET, COATED ORAL 20040114 20180527 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ASPIRIN 81 mg/1 E 20171231 55910-415_3d941002-457d-304e-e054-00144ff8d46c 55910-415 HUMAN OTC DRUG REXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH Benzocaine and Resorcinol CREAM TOPICAL 20160927 OTC MONOGRAPH FINAL part346 Dolgencorp, Inc. BENZOCAINE; RESORCINOL 20; 3 g/100g; g/100g N 20181231 55910-416_54358a22-13fd-2b91-e054-00144ff88e88 55910-416 HUMAN OTC DRUG REXALL HEMORRHOIDAL COOLING Phenylephrine Hydrochloride and Witch Hazel GEL TOPICAL 20170712 OTC MONOGRAPH FINAL part346 Dolgencorp, Inc. PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g N 20181231 55910-418_70433ad1-a174-4b7e-9e20-258f8aa278b5 55910-418 HUMAN OTC DRUG Skin Corrective BB Cream Broad Spectrum SPF15 Sunscreen Titanium Dioxide, Octinoxate CREAM TOPICAL 20130720 OTC MONOGRAPH NOT FINAL part352 Dolgencorp Inc. TITANIUM DIOXIDE; OCTINOXATE 2.1; 4 g/100mL; g/100mL N 20181231 55910-419_a7bfa1bb-3dd9-4a97-9287-07b60c4bcfba 55910-419 HUMAN OTC DRUG DG Health Childrens Mucus Relief Cough Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 20091114 OTC MONOGRAPH FINAL part341 Dolgencorp Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 55910-425_810c8101-2e57-4a8f-978a-58014d5fd430 55910-425 HUMAN OTC DRUG DG BODY 2 IN 1 DRY SCALP CARE PYRITHIONE ZINC LIQUID TOPICAL 20150428 OTC MONOGRAPH FINAL part358H DOLGENCORP INC PYRITHIONE ZINC 10 mg/mL N 20181231 55910-426_4ff26e82-af20-43ff-a84b-83c73eff5e97 55910-426 HUMAN OTC DRUG DG BODY 2 IN 1 SIMPLY CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20150428 OTC MONOGRAPH FINAL part358H DOLGENCORP INC PYRITHIONE ZINC 10 mg/mL N 20181231 55910-426_fc36843d-ed19-46e7-a438-0da8c5b6f1f0 55910-426 HUMAN OTC DRUG DG BODY 2 IN 1 SIMPLY CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20150527 OTC MONOGRAPH FINAL part358H DOLGENCORP INC PYRITHIONE ZINC 10 mg/mL N 20181231 55910-427_cf87a264-7ae2-4592-b9a5-1dd6f17916ed 55910-427 HUMAN OTC DRUG DG BODY SIMPLY CLEAN PYRITHIONE ZINC LIQUID TOPICAL 20150428 OTC MONOGRAPH FINAL part358H DOLGENCORP INC PYRITHIONE ZINC 10 mg/mL N 20181231 55910-428_16563b54-85b6-43a6-adf6-14cb78708980 55910-428 HUMAN OTC DRUG DG Health Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20100117 OTC MONOGRAPH FINAL part332 Dolgencorp, LLC DIMETHICONE 125 mg/1 N 20181231 55910-429_7ed0f9b6-bcc9-4beb-be06-ea0b8395b19e 55910-429 HUMAN OTC DRUG DG BODY 2 IN 1 GREEN APPLE PYRITHIONE ZINC LIQUID TOPICAL 20150427 OTC MONOGRAPH FINAL part358H DOLGENCORP INC PYRITHIONE ZINC 10 mg/mL N 20181231 55910-431_33fd2e78-29e1-4b51-8ad9-4147754d6a8f 55910-431 HUMAN OTC DRUG dg health sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20100124 OTC MONOGRAPH FINAL part338 Dolgencorp Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55910-433_23f6d25a-65ac-4310-8923-5bba2127e200 55910-433 HUMAN OTC DRUG DG BODY 2 IN 1 CLASSIC PYRITHIONE ZINC LIQUID TOPICAL 20150312 OTC MONOGRAPH FINAL part358H DOLGENCORP INC PYRITHIONE ZINC 10 mg/mL N 20181231 55910-434_fb60db1a-d06b-4ca8-9e4f-fc1965d4de11 55910-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20160311 OTC MONOGRAPH NOT FINAL part356 DOLGENCORP, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55910-435_c66f5722-d681-4d3c-b1fb-f755d4c854dc 55910-435 HUMAN OTC DRUG DG Health Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150817 ANDA ANDA075077 Dolgencorp, LLC ACETAMINOPHEN 650 mg/1 N 20181231 55910-437_b0c1baa7-9591-4ddc-b1b0-62798b5a91b6 55910-437 HUMAN OTC DRUG dg health pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20091121 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55910-438_d2c3355e-3722-4647-8172-fca2eaabc99d 55910-438 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20040414 20180603 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ASPIRIN 81 mg/1 E 20171231 55910-439_38047e96-cb3d-434b-8a8f-d6ef07e07a60 55910-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130222 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP, LLC ALCOHOL 700 mg/mL N 20181231 55910-445_87b0c0bb-221d-4f06-9826-5045d6c2a463 55910-445 HUMAN OTC DRUG dg health flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140315 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 55910-447_dfc7db89-53ab-400b-9187-ffa014152d46 55910-447 HUMAN OTC DRUG Rapid Melts Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050203 20201128 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN 80 mg/1 N 20191231 55910-449_87cb4eed-7a0f-4274-bc20-f52bcb65543c 55910-449 HUMAN OTC DRUG Junior Rapid Melts Acetaminophen TABLET, CHEWABLE ORAL 20050128 20200406 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN 160 mg/1 N 20181231 55910-455_0beedbe7-29d7-44d4-bab4-fd0e8c409288 55910-455 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl TABLET, FILM COATED ORAL 20050628 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 55910-456_05b7779a-1941-4d22-83be-6d9537183b49 55910-456 HUMAN OTC DRUG Rexall Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20110516 ANDA ANDA076777 Dolgencorp, LLC NICOTINE 2 mg/1 N 20181231 55910-458_fea41e0e-0645-4378-805f-646447a1d308 55910-458 HUMAN OTC DRUG dg health all day allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20100108 ANDA ANDA078336 Dolgencorp Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55910-459_d2650bce-386d-44c0-b55f-82af1b0bfc72 55910-459 HUMAN OTC DRUG dg health cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110815 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 55910-462_6791c6b2-69ac-409f-951f-35e43db22090 55910-462 HUMAN OTC DRUG dg health allergy diphenhydramine hydrochloride CAPSULE ORAL 20100222 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55910-464_a92e3ea1-24e6-4835-b60d-50169151e802 55910-464 HUMAN OTC DRUG Allergy Plus Sinus Headache Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET ORAL 20050615 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 55910-466_9d8e1c8c-c383-40dd-9160-cbf9c549d618 55910-466 HUMAN OTC DRUG Sinus and Headache Daytime Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55910-467_7648cf87-cd23-4e5a-b247-f34b1bcfc42b 55910-467 HUMAN OTC DRUG dg health aspirin Aspirin TABLET, CHEWABLE ORAL 20091204 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ASPIRIN 81 mg/1 N 20181231 55910-469_aa37400b-1537-4d3b-9264-1ee62815aafe 55910-469 HUMAN OTC DRUG rexall bismuth Bismuth subsalicylate TABLET, CHEWABLE ORAL 20120928 OTC MONOGRAPH FINAL part335 Dolgencorp Inc BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 55910-470_a4532de2-ab72-420d-9915-8b53feb8a471 55910-470 HUMAN OTC DRUG Cold Relief Maximum Strength / Day Time Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20050715 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55910-471_3202645b-ef43-481e-ac1d-7e7226459ec9 55910-471 HUMAN OTC DRUG Night Time Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20150831 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 55910-473_304e1943-313a-414b-acab-077e9e9cd91b 55910-473 HUMAN OTC DRUG Cold Head Congestion Night Time Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20050721 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55910-475_6f4e08a1-dc53-4227-9517-7d4f0a3e48d8 55910-475 HUMAN OTC DRUG rexall all day allergy relief childrens Cetirizine HCl SOLUTION ORAL 20151107 ANDA ANDA204226 Dolgencorp, LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 55910-479_532f9d87-f486-471c-a7b9-4240eaf931ed 55910-479 HUMAN OTC DRUG DG Health Allergy Diphenhydramine Hydrochloride TABLET ORAL 20100130 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55910-480_a379d3be-8334-4812-a32e-e6cfd3e6ff0d 55910-480 HUMAN OTC DRUG Nitetime cold and flu relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20120801 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 55910-483_deaf2841-c24a-4c68-8f0d-6c0ebd333115 55910-483 HUMAN OTC DRUG Allergy Relief Dye Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20151031 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55910-484_64849171-056c-40d6-97ee-4fe74d1d3b6a 55910-484 HUMAN OTC DRUG dg health pain reliever extra strength Acetaminophen TABLET ORAL 20091005 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 500 mg/1 N 20181231 55910-486_50c62208-aeb6-4041-abee-b688b97b7d25 55910-486 HUMAN OTC DRUG Senna Laxative Sennosides TABLET ORAL 20151209 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) SENNOSIDES A AND B 8.6 mg/1 N 20181231 55910-487_e536e420-4890-4347-8a5d-b2518a5e06ab 55910-487 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part347 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIMETHICONE 125 mg/1 N 20181231 55910-490_534eaf8a-0d2a-4390-af92-af5c98ba56a5 55910-490 HUMAN OTC DRUG DG Health Naproxen Sodium Naproxen Sodium TABLET ORAL 20160425 ANDA ANDA074661 Dolgencorp, LLC NAPROXEN SODIUM 220 mg/1 N 20181231 55910-491_5afa6b60-00bd-42dd-8df3-c2a9c76b1a95 55910-491 HUMAN OTC DRUG Pain Reliever Regular Strength Acetaminophen TABLET ORAL 20160229 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN 325 mg/1 N 20181231 55910-494_4d140c43-ce56-402e-8e79-4cdfd21578a9 55910-494 HUMAN OTC DRUG Childrens Rapid Melts Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN 160 mg/1 N 20181231 55910-498_39a41526-e97d-4633-9957-11d0f6e0ca23 55910-498 HUMAN OTC DRUG dg health mucus relief er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130517 ANDA ANDA078912 Dolgencorp, LLC GUAIFENESIN 600 mg/1 N 20181231 55910-499_5c57d127-7557-4c26-a2fe-1c8e5d466a21 55910-499 HUMAN OTC DRUG dg health cold and flu severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140527 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55910-500_a5e207d1-7737-41c4-b355-43fc2c6afdd1 55910-500 HUMAN OTC DRUG dg health naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20131121 ANDA ANDA074661 Dolgencorp, LLC NAPROXEN SODIUM 220 mg/1 N 20181231 55910-502_fc37a703-e230-4c38-a1c4-1d877b82c3f8 55910-502 HUMAN OTC DRUG Sinus Headache Maximum Strength Acetaminophen and Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55910-503_b16cbc70-b640-44c3-9e4d-8fac30f3d3f5 55910-503 HUMAN OTC DRUG Dg Health Ibuprofen ibuprofen SUSPENSION ORAL 20100222 ANDA ANDA075217 Dolgencorp, LLC IBUPROFEN 50 mg/1.25mL N 20181231 55910-505_abab018c-b625-44c9-a8ed-a40b5698bf2b 55910-505 HUMAN OTC DRUG Mucus Relief DM Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 55910-506_17bf4f8f-d8d7-4d92-a5ce-1c76c4d16cde 55910-506 HUMAN OTC DRUG DG Health Pain Relief Acetaminophen TABLET, FILM COATED ORAL 20170414 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 500 mg/1 N 20181231 55910-509_17435ddc-3ba0-42f8-a8b0-a0271b164ba8 55910-509 HUMAN OTC DRUG DG HEALTH MULTI SYMPTOM SEVERE COLD Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20170522 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 55910-511_debcda99-c605-4941-b873-9e4dbae27483 55910-511 HUMAN OTC DRUG DG HEalth Nasal Oxymetazoline hydrochloride SPRAY NASAL 20160703 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 55910-516_8bfc8783-3190-4a5f-9605-bbad15e0f66a 55910-516 HUMAN OTC DRUG DG Health tussin cf adult cough and cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20100522 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 55910-517_369ce2a7-cdf3-414a-95d4-7f4ae6768427 55910-517 HUMAN OTC DRUG rexall ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20120906 ANDA ANDA077349 Dolgencorp, LLC IBUPROFEN 200 mg/1 N 20181231 55910-519_16eaceb6-c8e2-4a6d-9267-f829c7f94ef3 55910-519 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20040510 20200719 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN 500 mg/1 N 20181231 55910-520_d2e0d4bc-267e-42db-bdb0-ed4909edf36f 55910-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20111110 NDA NDA021855 Dolgencorp, Inc. 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(DOLLAR GENERAL & REXALL) DIMETHICONE 180 mg/1 N 20181231 55910-531_61107ca9-f09e-4b41-bdcc-5d76d4e16759 55910-531 HUMAN OTC DRUG Pain Relief EZ tabs Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN 500 mg/1 N 20181231 55910-532_21cab372-fe40-4073-b123-9d18979b083a 55910-532 HUMAN OTC DRUG Rexall Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20110517 ANDA ANDA076779 Dolgencorp, LLC NICOTINE 4 mg/1 N 20181231 55910-536_7ad42602-6e42-47c8-91a8-e4785fa8d24b 55910-536 HUMAN OTC DRUG Rexall Antibiotic Bacitracin OINTMENT TOPICAL 20150922 OTC MONOGRAPH FINAL part333B Dolgencorp, LLC BACITRACIN 500 [USP'U]/g N 20181231 55910-539_fb8d13b3-f0b9-477c-9e20-34b50adbe585 55910-539 HUMAN OTC DRUG Childrens Allergy Loratadine LIQUID ORAL 20160229 ANDA ANDA077421 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) LORATADINE 5 mg/5mL N 20181231 55910-541_7c768d24-df60-4e9e-8a1a-97f2b8a39e68 55910-541 HUMAN OTC DRUG DG Health Hydrocortisone Hydrocortisone CREAM TOPICAL 20110114 OTC MONOGRAPH NOT FINAL part348 Dolgencorp, LLC HYDROCORTISONE 1 g/100g N 20181231 55910-544_560fe227-ab77-44b2-beb1-5cae5e22b8a3 55910-544 HUMAN OTC DRUG dg health arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100129 ANDA ANDA075077 Dolgencorp, LLC ACETAMINOPHEN 650 mg/1 N 20181231 55910-548_b311c8a2-514d-421c-8244-8754970a81bb 55910-548 HUMAN OTC DRUG DG Health Cold and Flu Relief Daytime acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140424 OTC MONOGRAPH FINAL part341 Dolgencorp Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55910-552_5364899b-59c8-4898-9abe-76d96cdb25ea 55910-552 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20150701 NDA NDA020065 DOLGENCORP, LLC NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL N 20181231 55910-553_5af05fce-e823-4edd-af67-9e30f210979e 55910-553 HUMAN OTC DRUG Ultra Protection SPF 70 Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10% Oxybenzone 6% LOTION TOPICAL 20130131 OTC MONOGRAPH NOT FINAL part352 Dollar General AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 55910-554_d9599348-aa3a-452f-9ce3-1a5a13f1a216 55910-554 HUMAN OTC DRUG Baby Broad Spectrum SPF 50 DG body Avobenzone - 3.0% Homosalate - 13.0% Octisalate - 5.0% Octocrylene - 7.0% Oxybenzone 4% LOTION TOPICAL 20120117 OTC MONOGRAPH NOT FINAL part352 Dollar General AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 55910-555_4dd364d7-3283-4b19-8f9c-b5a931d717ac 55910-555 HUMAN OTC DRUG Night Time Cold Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050721 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 55910-558_4b1d8ae9-4ad4-43e6-9467-dcfee4a4f2c3 55910-558 HUMAN OTC DRUG Sinus Relief Congestion and Pain Daytime Acetaminophen, Phenylephrine HCl TABLET ORAL 20080317 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55910-563_6364dd6e-b982-4e1f-8dd8-1b1b4d32d976 55910-563 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ASPIRIN 81 mg/1 N 20181231 55910-565_029a1ed2-7ae7-40e3-a2ca-74c5ce359bf9 55910-565 HUMAN OTC DRUG Ibuprofen PM IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED ORAL 20160229 ANDA ANDA090397 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE 200; 25 mg/1; mg/1 N 20181231 55910-566_04b791db-cb09-4cd5-9538-c0f9eac7b4d2 55910-566 HUMAN OTC DRUG Rexall Athletes Foot Clotrimazole CREAM TOPICAL 20150513 OTC MONOGRAPH FINAL part333C Dolgencorp LLC CLOTRIMAZOLE 1 g/100g N 20181231 55910-567_fb8d20ac-56e0-43d8-8e42-90f6880b4e35 55910-567 HUMAN OTC DRUG Rexall Jock Itch Clotrimazole CREAM TOPICAL 20150622 OTC MONOGRAPH FINAL part333C Dolgencorp, LLC CLOTRIMAZOLE 10 mg/g N 20181231 55910-568_2884edbc-a55b-48ba-871e-ebda71aeab6c 55910-568 HUMAN OTC DRUG Dollar General Health Oral Pain Reliever Benzocaine GEL TOPICAL 20150508 OTC MONOGRAPH NOT FINAL part356 Dolgencorp LLC BENZOCAINE HYDROCHLORIDE 200 mg/g N 20181231 55910-571_e8010558-2a4e-4195-9028-782a84c15810 55910-571 HUMAN OTC DRUG dg health aller ease fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110606 ANDA ANDA076447 Dolgencorp, LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 55910-573_6cb3459f-5a36-47f4-93e0-1b4389f3aca4 55910-573 HUMAN OTC DRUG Cold and Flu Severe Day Time / Night Time Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl KIT 20050804 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC N 20181231 55910-578_0beed9bf-155a-4a30-a7e5-1bb85c783839 55910-578 HUMAN OTC DRUG Stool Softener Laxative DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170831 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DOCUSATE SODIUM 100 mg/1 N 20181231 55910-580_ca9f0e4c-b467-4009-a728-65c08e91c156 55910-580 HUMAN OTC DRUG Rexall Daytime Nighttime Cold Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140525 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC N 20181231 55910-582_68015773-9103-459d-8e4e-ff1babec468b 55910-582 HUMAN OTC DRUG dg baby vitamins a and d Lanolin, Petrolatum OINTMENT TOPICAL 20100108 OTC MONOGRAPH FINAL part347 Dolgencorp Inc LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g N 20191231 55910-583_fe74a0ea-2707-499a-8e26-ed46579b81a0 55910-583 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20171001 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DOCUSATE SODIUM 100 mg/1 N 20181231 55910-584_9b418f18-e5f1-4f09-9258-f72f081fc491 55910-584 HUMAN OTC DRUG DM Cough and Congestion Relief Adult non-Drowsy Sugar Free Dextromethorphan Hydrobromide, Guaifenesin LIQUID ORAL 20160430 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/10mL; mg/10mL N 20181231 55910-586_ba1f530d-a1d2-4997-8336-e37036a92b4f 55910-586 HUMAN OTC DRUG DG Health Poly Antibiotic Bacitracin, and Polymyxin B OINTMENT TOPICAL 20160811 OTC MONOGRAPH FINAL part333B Dolgencorp, Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 55910-588_9b4c1d44-45ef-44b3-864e-5611b8384fc0 55910-588 HUMAN OTC DRUG Rexall Antacid Advanced Aluminum Hydroxide, Magnesium Hydroxide, Simethicone SUSPENSION ORAL 20140610 OTC MONOGRAPH FINAL part332 Dolgencorp Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 55910-589_f3ce4c0c-ab85-4f58-b3b5-ce002a1df043 55910-589 HUMAN OTC DRUG Ultra Chloroxylenol 0.3% LIQUID TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP, LLC CHLOROXYLENOL 3.09 g/mL N 20181231 55910-591_1e0dbdf2-60a4-45dd-a2aa-80160b1abab2 55910-591 HUMAN OTC DRUG DG Health Tussin dextromethorphan hbr, doxylamine succinate SOLUTION ORAL 20160425 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL N 20181231 55910-593_2b0e555d-3ed5-4ec4-82a6-855351c503b3 55910-593 HUMAN OTC DRUG DG Health Esomeprazole Magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170922 ANDA ANDA207193 Dolgencorp, LLC ESOMEPRAZOLE 20 mg/1 N 20181231 55910-595_3a0a84ee-fc29-45c0-9462-3cac74dafca4 55910-595 HUMAN OTC DRUG Rexall Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20150826 OTC MONOGRAPH FINAL part331 Dolgencorp, LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 55910-596_52f3f071-247a-4368-84ae-8802b4534da0 55910-596 HUMAN OTC DRUG Stomach Relief Childrens Calcium Carbonate TABLET, CHEWABLE ORAL 20110407 OTC MONOGRAPH FINAL part331 DOLGENCORP, LLC CALCIUM CARBONATE 400 mg/1 N 20181231 55910-600_a5d659ae-2753-46d8-a854-68cf18bf0604 55910-600 HUMAN OTC DRUG Aspirin 81 mg Aspirin TABLET, COATED ORAL 20080212 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ASPIRIN 81 mg/1 N 20191231 55910-601_5b1cd8e3-d3c1-4fb3-a8bb-a6941c30bc5e 55910-601 HUMAN OTC DRUG Dollar General Acne Spot Medication SALICYLIC ACID GEL TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333D DOLGENCORP, LLC SALICYLIC ACID 20 mg/mL E 20171231 55910-602_b25cbe68-36b1-42b6-a4dd-f18a1149ffab 55910-602 HUMAN OTC DRUG Rexall Vanishing Scent Pain Relieving MENTHOL GEL TOPICAL 20110314 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP, LLC MENTHOL 27.5 mg/g E 20171231 55910-603_e6cb14cb-b299-4697-a448-a98a4f161064 55910-603 HUMAN OTC DRUG REXALL HEMORRHOIDAL COOLING WITCH HAZEL, PHENYLEPHRINE HYDROCHLORIDE GEL TOPICAL 20101118 OTC MONOGRAPH FINAL part346 DOLLAR GENERAL WITCH HAZEL; PHENYLEPHRINE HYDROCHLORIDE 500; 2.5 mg/g; mg/g E 20171231 55910-604_ee6d8168-f68f-47ed-9f7f-f4cfffc3ba24 55910-604 HUMAN OTC DRUG dg health ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20091003 ANDA ANDA072096 Dolgencorp, LLC IBUPROFEN 200 mg/1 N 20181231 55910-606_9575a81f-3922-457c-8279-aa723d88ceda 55910-606 HUMAN OTC DRUG DG Health nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170414 ANDA ANDA206393 Dolgencorp, LLC NICOTINE 4 mg/1 N 20181231 55910-610_313a5b02-e006-4c61-a55e-c9112bc2d7bc 55910-610 HUMAN OTC DRUG DG Body MEDICATED DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20100929 OTC MONOGRAPH FINAL part358H DOLGENCORP INC SELENIUM SULFIDE 1 mL/100mL N 20181231 55910-616_507d84cf-5de8-49e8-9124-b22a91417e04 55910-616 HUMAN OTC DRUG REXALL ALOE SELENIUM SULFIDE LIQUID TOPICAL 20120925 OTC MONOGRAPH FINAL part358H DOLGENCORP INC. SELENIUM SULFIDE 1 mL/100mL N 20181231 55910-617_eaca99ac-84e1-4eba-9c5b-92992d1bd91e 55910-617 HUMAN OTC DRUG Severe Cold and Cough Night Time Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55910-620_3b3782e3-ee02-4460-9316-ea603bd5658b 55910-620 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20121003 OTC MONOGRAPH FINAL part336 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 55910-621_4d3adc48-b60e-4fb4-83b9-73c07137af56 55910-621 HUMAN OTC DRUG REXALL ALOE SELENIUM SULFIDE LIQUID TOPICAL 20150115 OTC MONOGRAPH FINAL part358H DOLGENCORP INC SELENIUM SULFIDE 10 mg/mL N 20181231 55910-621_ffa7c42d-5a7b-45d9-b2a9-a2980ef990b9 55910-621 HUMAN OTC DRUG REXALL ALOE SELENIUM SULFIDE LIQUID TOPICAL 20130731 OTC MONOGRAPH FINAL part358H DOLGENCORP INC. SELENIUM SULFIDE 10 mg/mL N 20181231 55910-625_a4730034-9f07-4f01-aaaa-4d2b866ae16f 55910-625 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20171231 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20191231 55910-628_1c8dfd4c-59f3-4e15-a41f-71a4b7cab7e1 55910-628 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20160217 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP,LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55910-633_bc93e950-460a-4c46-9750-bee9149bed00 55910-633 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20160226 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP, LLC BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 55910-641_5f0161ac-24ac-3cb4-e053-2a91aa0a627a 55910-641 HUMAN OTC DRUG DG Health Sterile Redness Relief TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 Dolgencorp Inc TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 55910-644_5eff783b-10be-4d29-e053-2a91aa0a0999 55910-644 HUMAN OTC DRUG DG Health Artifical Tears Glycerin, Hypromellose, and Polyethylene glycol 400 SOLUTION/ DROPS OPHTHALMIC 20170227 OTC MONOGRAPH FINAL part349 Dolgencorp Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2.5; 2; 11.28 mg/mL; mg/mL; mg/mL N 20181231 55910-645_6b9d4fb8-83a5-496a-b343-c2666d8a57ef 55910-645 HUMAN OTC DRUG dg health loperamide hydrochloride loperamide HCl LIQUID ORAL 20120726 ANDA ANDA091292 Dolgencorp Inc LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 55910-655_522b36f7-8b75-48dd-93bf-3d51e4c804dd 55910-655 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55910-656_69c526c9-4d0c-4b64-bb35-fab0822cd8df 55910-656 HUMAN OTC DRUG DG Health Cold and Flu Relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20090927 OTC MONOGRAPH FINAL part341 Dolgencorp Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 55910-661_80c62dd8-a8dc-4b5f-8cd5-3c4179f41562 55910-661 HUMAN OTC DRUG dg health pain relief Acetaminophen TABLET ORAL 20141021 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 500 mg/1 N 20181231 55910-664_bbacff4b-6d98-4e0b-8124-9c803afc935a 55910-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19940729 OTC MONOGRAPH NOT FINAL part356 Dolgencorp, llc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55910-666_57ad2d79-8779-43cf-9665-34ca1bf03c1c 55910-666 HUMAN OTC DRUG dg health cough and sore throat nite time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate SOLUTION ORAL 20100206 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 55910-667_57d02b57-bfa7-461c-b0b5-673f6d6d3e05 55910-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20090414 OTC MONOGRAPH FINAL part334 Dolgencorp, LLC MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 55910-668_5c5e6893-9dfb-49ca-9f8d-257c091b2549 55910-668 HUMAN OTC DRUG dg health cough night time Dextromethorphan Hydrobromide, Doxylamine Succinate SOLUTION ORAL 20091121 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 55910-679_0a04da51-d169-4eff-b70c-352913ce3966 55910-679 HUMAN OTC DRUG DG Health Antibiotic Bacitracin, Neomycin, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20150926 OTC MONOGRAPH FINAL part333B Dolgencorp, LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 55910-683_8ee2f3a1-9a42-4e02-9783-2a1ac29024b8 55910-683 HUMAN OTC DRUG Allergy Relief Dye Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20170531 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55910-684_ee8a9953-a5e5-44c8-ad44-0ff77733bde7 55910-684 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20171031 OTC MONOGRAPH NOT FINAL part334 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DOCUSATE SODIUM 100 mg/1 N 20181231 55910-685_0719a417-449f-4db8-90bc-95ec8e552d57 55910-685 HUMAN OTC DRUG Rexall Ibuprofen Ibuprofen SUSPENSION ORAL 20100819 ANDA ANDA074937 Dolgencorp Inc IBUPROFEN 100 mg/5mL N 20181231 55910-688_a591dec1-ea2f-41d5-aa8e-e94aa9939c03 55910-688 HUMAN OTC DRUG dg health sinus relief Oxymetazoline HCl SPRAY NASAL 20100222 OTC MONOGRAPH FINAL part341 Dolgencorp Inc OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL N 20181231 55910-689_e93b8f74-7a05-4dde-b3af-3aec65257bfd 55910-689 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine Maleate, Dextromethorphan HBr TABLET, COATED ORAL 20170331 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 55910-690_2bcbabe5-fcc0-44a6-9130-c77775d94265 55910-690 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 20150331 OTC MONOGRAPH FINAL part336 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55910-693_26fae660-650e-46b5-9fa4-4847b25338af 55910-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20110204 OTC MONOGRAPH NOT FINAL part334 DOLGENCORP LLC MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 55910-699_4d79fb74-1895-4efe-8016-c0dd5ed10f7a 55910-699 HUMAN OTC DRUG rexall all day allergy relief Cetirizine Hydrochloride TABLET ORAL 20120906 ANDA ANDA078336 Dolgencorp, LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 55910-700_34a80dcb-f444-4f97-8cbc-d0dd136a3c2f 55910-700 HUMAN OTC DRUG rexall anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20100815 ANDA ANDA075232 Dolgencorp, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20191231 55910-701_599dc9cd-eaba-4837-9891-9446fe83d938 55910-701 HUMAN OTC DRUG rexall pain relief Acetaminophen TABLET ORAL 20100807 OTC MONOGRAPH NOT FINAL part343 Dolgencorp Inc ACETAMINOPHEN 500 mg/1 N 20181231 55910-702_3e7ac451-348f-4ab2-b83b-76d5c58ba491 55910-702 HUMAN OTC DRUG rexall sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20100929 OTC MONOGRAPH FINAL part338 Dolgencorp, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55910-703_b93c44b0-e706-4baf-9037-1992bf5120ae 55910-703 HUMAN OTC DRUG Rexall Pain Relief Acetaminophen TABLET ORAL 20100921 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 500 mg/1 N 20181231 55910-704_9dcc26af-6d37-4ce5-addd-d1948e136e42 55910-704 HUMAN OTC DRUG Sunscreen for Kids Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20171201 OTC MONOGRAPH FINAL part352 DOLGENCORP, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 72.1; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; 1/mL N 20181231 55910-705_2e4f13eb-d76e-49ed-ba0f-cfed42dda3e5 55910-705 HUMAN OTC DRUG rexall lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20101119 OTC MONOGRAPH FINAL part358G Dolgencorp Inc PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 55910-707_4ede5e5c-e1c9-480f-911f-813f1177b499 55910-707 HUMAN OTC DRUG rexall miconazole 3 Miconazole nitrate KIT 20101214 ANDA ANDA075329 Dolgencorp Inc N 20181231 55910-708_f4f080a5-b9fa-4463-b49e-68edb1abdf80 55910-708 HUMAN OTC DRUG rexall antacid Calcium carbonate TABLET, CHEWABLE ORAL 20110510 OTC MONOGRAPH FINAL part331 Dolgencorp, LLC CALCIUM CARBONATE 750 mg/1 N 20181231 55910-711_56978c72-8b57-4633-970f-f4c8fdd50ac3 55910-711 HUMAN OTC DRUG ultra sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20171128 OTC MONOGRAPH FINAL part352 DOLGENCORP, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 133.9; 51.5; 72.1; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; 1/mL N 20181231 55910-717_7cd8cde6-707e-4570-8282-5a1811c3c11d 55910-717 HUMAN OTC DRUG DG Health Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160427 OTC MONOGRAPH FINAL part331 Dolgencorp, LLC CALCIUM CARBONATE 750 mg/1 N 20181231 55910-719_7486dadf-cd61-478c-8c0e-ad14f7e7ac6d 55910-719 HUMAN OTC DRUG DG Health Cold Max acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20160520 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 55910-720_aa672564-4015-4950-ae92-2ef9b6da97aa 55910-720 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130530 OTC MONOGRAPH FINAL part336 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 55910-721_431cc449-fe38-4896-929f-a131709c1eca 55910-721 HUMAN OTC DRUG DG BODY REFRESHING CLEAN BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55910-721_6ac2f8f4-1de7-4e5e-84a2-171bdb907c0e 55910-721 HUMAN OTC DRUG DG BODY REFRESHING CLEAN BENZALKONIUM CHLORIDE LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55910-721_c56589f2-eb9f-4958-a8d6-00cd04445e8c 55910-721 HUMAN OTC DRUG DG BODY REFRESHING CLEAN BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55910-721_ee7333c6-e36f-41a8-8c20-51fe5fa985b6 55910-721 HUMAN OTC DRUG DG BODY REFRESHING CLEAN BENZALKONIUM CHLORIDE LIQUID TOPICAL 20150617 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55910-724_2ba5efc4-10a7-43b8-84b8-fc14f91d1b00 55910-724 HUMAN OTC DRUG DG BODY REFRESHING CITRUS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20150616 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55910-724_402f50d2-fc92-4612-9a8f-e6969690459a 55910-724 HUMAN OTC DRUG DG BODY REFRESHING CITRUS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55910-724_4a4200ec-d465-4ec7-bfdb-597c4203133b 55910-724 HUMAN OTC DRUG DG BODY REFRESHING CITRUS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20150616 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55910-724_a0c4f4b6-5cb5-4e48-b70b-46a0af5f5592 55910-724 HUMAN OTC DRUG DG BODY REFRESHING CITRUS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E DOLGENCORP INC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 55910-727_46ab7731-a6f4-4f50-a082-9d0984b9b3bd 55910-727 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20171121 OTC MONOGRAPH FINAL part352 DOLGENCORP, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 26.49; 132.45; 44.15; 52.98 mg/g; mg/g; mg/g; mg/g N 20181231 55910-728_da73a818-736e-4fb8-a3a8-63e6cf178c5a 55910-728 HUMAN OTC DRUG DG Health Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160420 ANDA ANDA091009 Dolgencorp, LLC GUAIFENESIN 1200 mg/1 N 20181231 55910-735_5b75553b-e8e7-4a27-a421-2c8c68d77b8e 55910-735 HUMAN OTC DRUG DG Health Mucus DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160426 ANDA ANDA091070 Dolgencorp, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 55910-737_9db45074-12e6-4e49-80ba-bfa7c80e7c00 55910-737 HUMAN OTC DRUG DG Health Cold and Flu Relief acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20140520 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 55910-749_d102e8a2-2fff-48cb-9864-7582fde956ed 55910-749 HUMAN OTC DRUG DG Health 8 Hour Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170224 ANDA ANDA075077 Dolgencorp, LLC ACETAMINOPHEN 650 mg/1 N 20181231 55910-751_25f5d442-dd33-45b6-95c1-09bb3012ae70 55910-751 HUMAN OTC DRUG dg health pain relief pm Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20110127 OTC MONOGRAPH NOT FINAL part343 Dolgencorp Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 55910-763_553d21d6-0122-4085-985f-9155f3f3ad76 55910-763 HUMAN OTC DRUG dg health cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140525 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 55910-764_e2d8d630-8604-479b-ba43-09f4c186ae69 55910-764 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20171101 OTC MONOGRAPH FINAL part352 DOLGENCORP, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.6; 119; 45.9; 45.9; 55.08 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 55910-768_a8926e6a-d568-4465-8a14-677eec0598ac 55910-768 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20170430 ANDA ANDA079174 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) IBUPROFEN 200 mg/1 N 20181231 55910-773_6e4eaaf3-330b-43ea-83bf-f35190dc60db 55910-773 HUMAN OTC DRUG DG Health Allergy Relief Nasal Fluticasone propionate SPRAY, METERED NASAL 20160919 ANDA ANDA207957 Dolgencorp, LLC FLUTICASONE PROPIONATE 50 ug/1 N 20181231 55910-777_b0bb5173-50c6-42cc-b2c6-8b4e90c432f6 55910-777 HUMAN OTC DRUG Tanning Dry Oil SPF 15 Dollar General Avobenzone 2.00% Homosalate 10.00% Octisalate 5.00% Oxybenzone 3.00% SPRAY TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Dollar General AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2; 10; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 55910-778_3bbc1dcc-0b12-4340-a2b5-146fca3dbd47 55910-778 HUMAN OTC DRUG Rexall Sinus Nasal Pump Mist Oxymetazoline Hydrochloride 0.05% LIQUID TOPICAL 20151221 OTC MONOGRAPH FINAL part341 Dollar General OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 55910-787_b88fdbc0-5b75-401d-aab5-0d6096c47a08 55910-787 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20171129 OTC MONOGRAPH FINAL part352 DOLGENCORP, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 20; 150; 50; 40 mg/g; mg/g; mg/g; mg/g N 20181231 55910-788_c306e335-cf77-4dbe-8fe2-2221fd8745ba 55910-788 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20170807 OTC MONOGRAPH FINAL part352 DOLGENCORP, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27.03; 135.15; 45.05; 90.1; 54.06 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 55910-789_38930e6d-835a-4185-8cb5-f7a07ae75910 55910-789 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20171128 OTC MONOGRAPH FINAL part352 DOLGENCORP, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 26.07; 86.9; 43.45; 34.76; 43.45 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 55910-799_6056e402-5d54-46a4-a523-a1a098c87a3a 55910-799 HUMAN OTC DRUG rexall dm cough and congestion relief Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20120510 OTC MONOGRAPH FINAL part341 Dolgencorp Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 55910-800_e3d4a959-7ad0-47a6-86ed-2c5cccc9e7a1 55910-800 HUMAN OTC DRUG dg health stomach relief maximum strength Bismuth subsalicylate SUSPENSION ORAL 20120909 OTC MONOGRAPH FINAL part335 Dolgencorp Inc BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 55910-801_762956c1-aad9-4fec-8a13-f19e74e5d731 55910-801 HUMAN OTC DRUG Severe Cold and Cough Relief Daytime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20170331 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 55910-803_a9a0133b-d279-4988-95a6-032246e8edff 55910-803 HUMAN OTC DRUG Baby Eczema Therapy Colloidal oatmeal CREAM TOPICAL 20160411 OTC MONOGRAPH FINAL part347 DOLGENCORP, LLC OATMEAL 10.4 kg/g N 20181231 55910-804_81734f60-7e81-46bd-b2e7-2ff6d66216b7 55910-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333A Dolgencorp ISOPROPYL ALCOHOL .91 mg/mL N 20181231 55910-806_6ba07941-592f-4847-8707-7f5e7232c759 55910-806 HUMAN OTC DRUG dg health allergy relief Loratadine TABLET ORAL 20120413 ANDA ANDA076301 Dolgencorp, LLC LORATADINE 10 mg/1 N 20181231 55910-809_91f48dbc-954a-4462-a7be-c898a43a9abb 55910-809 HUMAN OTC DRUG Rexall Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333A Dolgencorp, LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 55910-810_faec8d43-ecf8-45d3-8559-c1d842438353 55910-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP,LLC ISOPROPYL ALCOHOL 500 mg/mL N 20181231 55910-812_1d4c4d9e-15c3-4e2e-810f-2c21ca385fb3 55910-812 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN 500 mg/1 N 20181231 55910-815_c0fac080-64d0-4c58-b93a-262495cf61a8 55910-815 HUMAN OTC DRUG DG Ice Cold Analgesic Menthol GEL TOPICAL 20100611 OTC MONOGRAPH FINAL part348 Dolgencorp, LLC MENTHOL 2 g/100g N 20181231 55910-821_638358c6-6f51-42da-84c2-b89503bfb55b 55910-821 HUMAN OTC DRUG Acne Scrub Salicylic Acid GEL TOPICAL 20150115 OTC MONOGRAPH FINAL part333D DOLGENCORP, LLC SALICYLIC ACID 21 mg/mL N 20181231 55910-822_a8217083-5679-4f55-afbc-d7e5e5f4011c 55910-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 19890705 OTC MONOGRAPH FINAL part347 Dolgencorp, LLC WITCH HAZEL 979 mg/mL N 20181231 55910-824_be22e8be-3918-4a10-8029-6ab668582a00 55910-824 HUMAN OTC DRUG Oral Pain Reliever Benzocaine LIQUID ORAL 20120110 OTC MONOGRAPH FINAL part333B Dolgencorp LLC BENZOCAINE 20 g/100g N 20181231 55910-825_df810ef7-5bd8-4bf2-b322-1b6c0531d2c3 55910-825 HUMAN OTC DRUG ACNE CONTROL CLEANSER BENZOYL PEROXIDE CREAM TOPICAL 20111025 OTC MONOGRAPH NOT FINAL part333D DOLGENCORP INC BENZOYL PEROXIDE 10 g/100g N 20181231 55910-826_38378e77-bf6c-4e25-a3d2-8bb0c19946a4 55910-826 HUMAN OTC DRUG Diaper Rash Zinc oxide CREAM TOPICAL 20120214 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP, LLC ZINC OXIDE 130 mg/g N 20181231 55910-831_0213a390-077f-4d8e-944b-2ef564bdfdf5 55910-831 HUMAN OTC DRUG Mineral Oil Mineral Oil LIQUID ORAL; TOPICAL 20100916 OTC MONOGRAPH NOT FINAL part334 DOLGENCORP, LLC MINERAL OIL 999 mg/mL N 20181231 55910-839_8390145b-2118-46f5-9610-e47131ee806d 55910-839 HUMAN OTC DRUG dg health childrens mucus relief dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20150506 OTC MONOGRAPH FINAL part341 Dolgencorp Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 55910-840_60a304b3-235b-313e-e053-2a91aa0a4ec8 55910-840 HUMAN OTC DRUG Lidocaine Burn Relief AEROSOL, SPRAY TOPICAL 20170508 OTC MONOGRAPH NOT FINAL part348 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) LIDOCAINE .64 g/127g N 20181231 55910-842_723cabf6-9b22-4043-aa12-0b95618226fb 55910-842 HUMAN OTC DRUG Lidocaine Burn Relief AEROSOL, SPRAY TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part348 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) LIDOCAINE .64 g/127g N 20181231 55910-852_36e51ed5-166a-4d92-b98b-79d04b938fe1 55910-852 HUMAN OTC DRUG DG Health Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130829 ANDA ANDA091429 Dolgencorp, LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 55910-864_dbb2b924-4776-473b-8452-77eafa41b7bc 55910-864 HUMAN OTC DRUG 50% Rubbing Isopropyl Alcohol LIQUID TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP,LLC ISOPROPYL ALCOHOL 500 mg/mL N 20181231 55910-871_9f01730d-3523-4749-ac42-07a204e78735 55910-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 19891115 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP, LLC HYDROGEN PEROXIDE .3 kg/100L N 20191231 55910-872_eb576e64-274e-47a9-8031-6d0a1ee35ddc 55910-872 HUMAN OTC DRUG rexall night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20120909 OTC MONOGRAPH FINAL part341 Dolgencorp Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 55910-875_57844095-234e-44e1-bf15-2ed0a3db8d0e 55910-875 HUMAN OTC DRUG Salicylic Acid Astringent LIQUID TOPICAL 20160727 OTC MONOGRAPH FINAL part333D DOLGENCORP, LLC SALICYLIC ACID 5 mg/mL N 20181231 55910-881_3d1aeaea-4c10-42a5-b8d0-84f5b2fe714e 55910-881 HUMAN OTC DRUG DG Health Antacid calcium carbonate TABLET, CHEWABLE ORAL 20150929 OTC MONOGRAPH FINAL part331 Dolgencorp, LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 55910-890_820135cc-83f3-4435-b209-13c24f03118e 55910-890 HUMAN OTC DRUG Cold and Allergy Maximum Strength Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20130430 OTC MONOGRAPH FINAL part341 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 55910-893_c3a30b2e-ba45-4f40-af29-14fb28feec17 55910-893 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20080715 OTC MONOGRAPH FINAL part355 Dolgencorp, LLC SODIUM FLUORIDE .0221 kg/100L N 20181231 55910-897_804f89d9-e60b-4a6e-a706-c3439ebe755d 55910-897 HUMAN OTC DRUG DG Health Ibuprofen Ibuprofen SUSPENSION ORAL 20100206 ANDA ANDA074937 Dolgencorp Inc IBUPROFEN 100 mg/5mL N 20181231 55910-898_c04ef0bf-41ec-4bec-87c3-4180355f3321 55910-898 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 19981208 OTC MONOGRAPH FINAL part358H DOLGENCORP, LLC PYRITHIONE ZINC 14 mg/mL N 20191231 55910-902_be8f99cb-89e6-40f2-90d5-21cbcabad0b8 55910-902 HUMAN OTC DRUG rexall ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20120824 ANDA ANDA072096 Dolgencorp Inc IBUPROFEN 200 mg/1 N 20181231 55910-903_6087d9d6-c3c1-4caa-aa05-e7212f9cf56d 55910-903 HUMAN OTC DRUG Dollar General Cold-Hot Medicated Patches MENTHOL PATCH TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP, LLC MENTHOL 5 1/1 N 20181231 55910-906_a713918b-a9f3-4650-bf47-007fd3b9c57c 55910-906 HUMAN OTC DRUG dg health cold and allergy childrens phenylephrine hcl, brompheniramine maleate SOLUTION ORAL 20100117 OTC MONOGRAPH FINAL part341 Dolgencorp Inc PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 55910-907_f598a097-93d5-4967-8fb0-ec88d04cc78e 55910-907 HUMAN OTC DRUG Dollar General Medicated Pain Relief Patch CAMPHOR, MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP, LLC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 6; 10 g/100g; g/100g; g/100g N 20181231 55910-911_a3f55114-a9b2-4b9b-9ab0-f3d526a71850 55910-911 HUMAN OTC DRUG DG Health Pain Relieving Menthol PATCH TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP INC MENTHOL 750 mg/1 N 20181231 55910-912_d348fe06-c422-4555-a7bc-8e2d09e1c90a 55910-912 HUMAN OTC DRUG Dollar General Pain Relieving Patch with Lidocaine LIDOCAINE PATCH TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP, LLC LIDOCAINE 4 g/100g N 20181231 55910-913_983907eb-c67f-4caa-9b77-cbaf622ee4f3 55910-913 HUMAN OTC DRUG dg health triacting night time cold and cough Diphenhydramine HCl, Phenylephrine HCl SOLUTION ORAL 20091114 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE 2.5; 6.25 mg/5mL; mg/5mL N 20181231 55910-915_bc539659-503f-406f-88bb-72e4a9b89604 55910-915 HUMAN OTC DRUG dg health omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20100214 NDA NDA022032 Dolgencorp, LLC OMEPRAZOLE 20 mg/1 N 20181231 55910-917_bd89f242-6432-4391-a092-f5a2a859da25 55910-917 HUMAN OTC DRUG dg health pain reliever Acetaminophen CAPSULE, COATED ORAL 20110131 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 500 mg/1 N 20181231 55910-920_305ce267-a30a-409c-8376-2b02a8f72194 55910-920 HUMAN OTC DRUG DG Health Pain Relief Cold Night Time acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20150930 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 55910-925_1975d678-06af-4853-b5e2-6c089c1850ac 55910-925 HUMAN OTC DRUG Sinus Pressure and Pain Maximum Strength Acetaminophen, Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 55910-927_f335a24f-657d-46db-af0d-3e5214768d79 55910-927 HUMAN OTC DRUG Cold and Head Congestion Severe Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 55910-932_4b9178f0-ed1e-40a0-9fa5-57262a179069 55910-932 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 DOLGENCORP, LLC IBUPROFEN 200 mg/1 N 20181231 55910-935_ac4bf3bb-182c-4fd4-b7ce-e1a3824da90f 55910-935 HUMAN OTC DRUG dg health sinus congestion and pain Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20100111 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 55910-941_04919169-8121-4491-a328-e7ea0a75d589 55910-941 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20150821 OTC MONOGRAPH FINAL part355 DOLGENCORP, LLC SODIUM FLUORIDE .2 mg/mL N 20181231 55910-942_7cef6c86-afb0-45e8-b807-a9cfc9215181 55910-942 HUMAN OTC DRUG 2 in 1 Dandruff Pyrithione zinc SHAMPOO TOPICAL 20160118 OTC MONOGRAPH FINAL part358H DOLGENCORP, LLC PYRITHIONE ZINC 1 g/mL N 20181231 55910-944_f06f4e5e-ea68-4b7c-a514-841cd2528042 55910-944 HUMAN OTC DRUG Childrens Chewables Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN 160 mg/1 N 20181231 55910-945_12b890e5-a7f0-469f-94b0-d7fcaf45ba4d 55910-945 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ASPIRIN 81 mg/1 N 20181231 55910-946_628b0634-11c9-4fe2-a759-9fa214494fe3 55910-946 HUMAN OTC DRUG dg health infants pain and fever Acetaminophen SUSPENSION ORAL 20111119 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 55910-947_75c536ee-b4c7-449e-96fa-a2ab13bcced0 55910-947 HUMAN OTC DRUG Acne Wash Salicylic Acid LOTION TOPICAL 20080608 OTC MONOGRAPH FINAL part333D DOLGENCORP, LLC SALICYLIC ACID 20.6 mg/mL N 20181231 55910-950_d0ba3a1d-8c76-452f-9eeb-e03ef437407b 55910-950 HUMAN OTC DRUG rexall heartburn relief Ranitidine TABLET, FILM COATED ORAL 20111003 ANDA ANDA091429 Dolgencorp, LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 55910-951_a075349b-4936-448d-a27f-44c4f2a7e9ad 55910-951 HUMAN OTC DRUG Instant Hand sanitizer ALCOHOL GEL TOPICAL 20110429 OTC MONOGRAPH NOT FINAL part333A Dolgencorp, LLC ALCOHOL 65 kg/100L N 20181231 55910-952_bb79dc21-86bd-4c27-ac62-94115079c39f 55910-952 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20130306 OTC MONOGRAPH NOT FINAL part333A DOLGENCORP, INC ALCOHOL 70 mL/100mL N 20181231 55910-955_dbfe1185-a4e5-42f2-af85-09462fabf4af 55910-955 HUMAN OTC DRUG Allergy Relief Multi-Symptom Acetaminophen, Phenylephrine HCl, Chlorpheniramine maleate TABLET ORAL 20080317 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 55910-956_d6b1d43e-0cab-4b29-a1ff-5e504e5bffc8 55910-956 HUMAN OTC DRUG Cold/Flu Multi-Symptom Relief Daytime/Nighttime Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20080329 OTC MONOGRAPH FINAL part341 DOLGENCORP, LLC N 20181231 55910-957_f70edc3c-bfbd-4117-9765-3e426cf888e4 55910-957 HUMAN OTC DRUG Rexall Nicotine Nicotine Polacrilex LOZENGE ORAL 20130808 ANDA ANDA203690 Dolgencorp, LLC NICOTINE 4 mg/1 N 20181231 55910-958_5687b4e7-4028-484f-a18b-df7e59a51d8e 55910-958 HUMAN OTC DRUG DG Health Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130710 ANDA ANDA091135 Dolgencorp, LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 55910-964_091685d0-2f83-43fa-a0cd-858efd9ca4cc 55910-964 HUMAN OTC DRUG dg health flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20110524 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 55910-966_2a79df9c-bf14-47e4-b273-182ca98400b5 55910-966 HUMAN OTC DRUG Rexall Arthritis Pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130731 ANDA ANDA075077 Dolgencorp, LLC ACETAMINOPHEN 650 mg/1 N 20181231 55910-967_47a6d541-c611-4073-81de-65a990237cbf 55910-967 HUMAN OTC DRUG Menstrual Pain Relief Maximum Strength / Multi Symptom Acetaminophen, Pamabrom, Pyrilamine maleate TABLET, FILM COATED ORAL 20150113 OTC MONOGRAPH NOT FINAL part343 DOLGENCORP, LLC ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 55910-972_89f261a9-3445-4aca-afe6-96c81e466f1a 55910-972 HUMAN OTC DRUG Dollar General Cold-Hot Medicated Patches MENTHOL PATCH TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part348 DOLGENCORP, LLC MENTHOL 5 g/1 N 20181231 55910-973_9ce0d271-739c-42de-aa98-7a5c44c0a5f5 55910-973 HUMAN OTC DRUG rexall hydrocortisone plus moisturizers hydrocortisone CREAM TOPICAL 20110114 OTC MONOGRAPH NOT FINAL part348 Dolgencorp, LLC HYDROCORTISONE 1 g/100g N 20181231 55910-974_2e3499f6-9660-4dc6-8000-b2d790b2397e 55910-974 HUMAN OTC DRUG rexall allergy relief cetirizine hydrochloride LIQUID ORAL 20100807 ANDA ANDA090254 Dolgencorp, LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 55910-975_b2106700-1bcc-45d9-ba14-29f7194cef1f 55910-975 HUMAN OTC DRUG Rexall Pain Relief Acetaminophen TABLET ORAL 20130807 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN 500 mg/1 N 20181231 55910-977_68616aec-57fc-42f9-b303-37811296fcd9 55910-977 HUMAN OTC DRUG dg health cold and flu relief night time Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20091117 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 55910-979_a5040b07-43dc-4d7d-8d2d-9dc308e14a0c 55910-979 HUMAN OTC DRUG Castor Oil Castor Oil LIQUID ORAL 20171023 OTC MONOGRAPH NOT FINAL part334 DOLGENCORP, LLC CASTOR OIL 1 g/mL N 20181231 55910-987_ef65dd77-9a56-4fac-a016-d9bec76eb93d 55910-987 HUMAN OTC DRUG DG Health Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20160504 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 55910-988_18100574-de1f-6303-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1811feff-93c3-1a93-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1811feff-93c6-1a93-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1811feff-93cc-1a93-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_18130c50-278a-4277-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_181d9743-5a01-268a-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_181d9743-5a06-268a-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_181d9743-5a0c-268a-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_181d9743-5a12-268a-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_182035fa-7752-2bf3-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_182035fa-7756-2bf3-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_182035fa-7761-2bf3-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_182035fa-7765-2bf3-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_182035fa-7769-2bf3-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1c14a331-db7a-41ef-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150730 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1c216f21-0e3a-468d-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1c216f21-0e47-468d-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1c216f21-0e51-468d-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1c216f21-0e57-468d-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1c26365c-a8b1-0bbb-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1c26365c-a8b5-0bbb-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1c26365c-a8ba-0bbb-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1c26365c-a8bf-0bbb-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1c26365c-a8c5-0bbb-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1c26365c-a8ca-0bbb-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_1d3d19b8-6493-316b-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_2c44df9f-5a3a-6686-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20160222 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_2c44df9f-5a44-6686-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20160222 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_2c53a312-56eb-3b3b-e054-00144ff88e88 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20160222 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_2c544d4d-7cf4-323d-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20160222 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_2c544d4d-7cfa-323d-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20160222 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_2c54da86-5091-6adb-e054-00144ff8d46c 55910-988 HUMAN OTC DRUG anti bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc. ALCOHOL 62 mL/100mL N 20181231 55910-988_531e77e0-c06d-4738-a528-78e70ff2d960 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL N 20181231 55910-988_806f7399-6882-49b2-a590-a39d3fe65422 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL N 20181231 55910-988_92d20135-bcb1-4691-b072-c829152b5f62 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL N 20181231 55910-988_973793bf-190b-448d-8c16-9fc05358ca08 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL N 20181231 55910-988_a05727f7-280d-4864-b4f6-45853f7d3d87 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL N 20181231 55910-988_a66ada3e-bf6d-4900-bde8-062c2c94cc58 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL N 20181231 55910-988_a7c0a6bb-b395-46e3-8e44-50d52a699245 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL N 20181231 55910-988_ac9507ee-18eb-493e-ac1e-6a1d03c24f69 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL N 20181231 55910-988_bb42a41f-8de0-4067-8c51-6db38444cc17 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL N 20181231 55910-988_be299127-e993-4304-96f6-ac25fd273077 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL N 20181231 55910-988_c3405e64-971e-41db-bc95-fcafc38e8715 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL N 20181231 55910-988_e662ee78-4e1d-4f4c-ba2d-2ed78b57d1e6 55910-988 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140903 OTC MONOGRAPH NOT FINAL part333E Dolgencorp Inc ALCOHOL 62 mL/100mL N 20181231 55910-990_adf28daa-5b8d-4eae-9b7f-3a42e4c821c6 55910-990 HUMAN OTC DRUG rexall night time cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate LIQUID ORAL 20100810 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 55910-991_cc160711-eeae-45d9-8cdf-1cbaeb051983 55910-991 HUMAN OTC DRUG Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20170318 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 55910-992_08e49667-0733-4400-a55c-fa9a81fbc6ce 55910-992 HUMAN OTC DRUG Mucus Relief DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Dolgencorp, LLC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 600; 30 mg/1; mg/1 N 20181231 55910-993_8333bd1f-d914-49a3-b591-fed23bd32a1d 55910-993 HUMAN OTC DRUG Maximum Strength Mucus Relief DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Dolgencorp, LLC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 55910-994_50d29351-3e23-4aad-8d32-786830313deb 55910-994 HUMAN OTC DRUG dg health cold plus flu relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20091002 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 55910-995_ceaeb4a0-90db-4a07-81dc-6c37571adce5 55910-995 HUMAN OTC DRUG Severe Cold and Mucus acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, guaifenesin LIQUID ORAL 20160304 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 55910-996_56535f0c-d5f3-483b-a9a5-dd0efcaa7866 55910-996 HUMAN OTC DRUG Pain Relief plus Sleep Aid acetaminophen, diphenhydramine hydrochloride LIQUID ORAL 20160229 OTC MONOGRAPH NOT FINAL part343 Dolgencorp, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/15mL; mg/15mL N 20181231 55910-997_8ffb9b51-59df-4a47-982c-38648a25dff9 55910-997 HUMAN OTC DRUG Night Time Cold Max acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride LIQUID ORAL 20160304 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 55910-998_57be5476-4a34-43d0-8bdb-e12cd44fa467 55910-998 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride SOLUTION ORAL 20160222 OTC MONOGRAPH FINAL part341 Dolgencorp, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/20mL N 20181231 55918-001_ac036ab4-3bae-41ac-a96a-ee269149ac19 55918-001 HUMAN PRESCRIPTION DRUG Phocal Apf Sodium Fluoride, hydrofluoric acid DISC TOPICAL 20130101 UNAPPROVED DRUG OTHER U.S.I.A. Inc SODIUM FLUORIDE; HYDROFLUORIC ACID .0466; .0094 mg/1; mg/1 E 20171231 55918-002_53bd9eed-c82e-4efc-a073-8f9e8fc166be 55918-002 HUMAN PRESCRIPTION DRUG Phocal pHn Sodium Fluoride DISC TOPICAL 20130101 UNAPPROVED DRUG OTHER Phocal Therapy Inc SODIUM FLUORIDE .055 mg/1 E 20171231 55924-0001_785dc00b-da8c-415c-908f-a7ee6b23997c 55924-0001 HUMAN PRESCRIPTION DRUG Ultra Ambrosia artemisiaefolia, Anacardium orientale, Baryta muriatica, Calcarea carbonica, Calcarea phosphorica, Fucus Vesiculosus, Helleborus niger, Hypothalamus, Ignatia amara, Lycopodium clavatum, Magnesia phosphorica, Manganum metallicum, Nicotinamidum, Phosphorus, Secale Cornutum, Silicea, Solidago virgaurea, Thymus serpyllum, Thyroidinum LIQUID ORAL 20130503 UNAPPROVED HOMEOPATHIC Soza Clinic AMBROSIA ARTEMISIIFOLIA; SEMECARPUS ANACARDIUM JUICE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; FUCUS VESICULOSUS; HELLEBORUS NIGER ROOT; BOS TAURUS HYPOTHALAMUS; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE; NIACINAMIDE; PHOSPHORUS; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; THYMUS SERPYLLUM; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 55924-0002_ba265c18-aacd-4a98-b1f2-e31ae6fee62d 55924-0002 HUMAN PRESCRIPTION DRUG Ultra Pure Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, flos, Anacardium orientale, Antimonium crudum, Calcarea carbonica, Castanea sativa, flos, Cortisone aceticum, Fucus vesiculosus, Hypothalamus, Kali bichromicum, Oleander, Pituitarum posterium, Sabadilla, Staphysagria, Thyroidinum LIQUID ORAL 20130528 UNAPPROVED HOMEOPATHIC Soza Clinic EPINEPHRINE; CORTICOTROPIN; AGRIMONIA EUPATORIA FLOWER; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CASTANEA SATIVA FLOWER; CORTISONE ACETATE; FUCUS VESICULOSUS; BOS TAURUS HYPOTHALAMUS; POTASSIUM DICHROMATE; NERIUM OLEANDER LEAF; SUS SCROFA PITUITARY GLAND; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] N 20181231 55924-1001_3bf71726-45af-42dd-8172-0441ee180730 55924-1001 HUMAN OTC DRUG ADVANTAGE ABROTANUM, ANACARDIUM ORIENTALE, BARYTA MURIATICA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, FUCUS VESICULOSUS, GRAPHITES LIQUID ORAL 20141215 UNAPPROVED HOMEOPATHIC Soza Clinic ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; FUCUS VESICULOSUS; GRAPHITE; HELLEBORUS NIGER ROOT; SUS SCROFA HYPOTHALAMUS; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA THYROID; THYMUS SERPYLLUM 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55924-2001_4f696521-921a-4fb8-0d0d-7ddd368a6e4a 55924-2001 HUMAN OTC DRUG ULTRA PRO artemisia abrotanum flowering top, semecarpus anacardium juice, barium chloride dihydrate, oyster shell calcium carbonate, crude, tribasic calcium phosphate, fucus vesiculosus, graphite, helleborus niger root, bos taurus hypothalamus, strychnos ignatii seed, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate, claviceps purpurea sclerotium, silicon dioxide, solidago virgaurea flowering top, thymus serpyllum and thyroid, unspecified LIQUID ORAL 20130301 UNAPPROVED HOMEOPATHIC SENA LLC ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; FUCUS VESICULOSUS; GRAPHITE; HELLEBORUS NIGER ROOT; BOS TAURUS HYPOTHALAMUS; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; THYMUS SERPYLLUM; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 15; 10; 10; 10; 10; 10; 10; 10; 15 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 55926-0011_8d7e21c4-e8c5-4d45-ba24-f7a9e0cf593c 55926-0011 HUMAN OTC DRUG Tranquil Remedy No. 11 Adrenalinum, Alfalfa, Ambrosia artemisiaefolia, Anacardium orientale, Argentum nitricum, Avena sativa, Aesculus hippocastanum, flos, Calcarea carbonica, Carboneum oxygenisatum, Carpinus betulus, flos, Citricum acidum, Gelsemium sempervirens, Hypothalamus, Kali phosphoricum, Lecithin, Natrum muriaticum, Olea europaea, flos, Phosphoricum acidum, Pituitarum posterium, Selenium metallicum, Sepia, Silicea, Thyroidinum LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC EPINEPHRINE; ALFALFA; AMBROSIA ARTEMISIIFOLIA; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; AVENA SATIVA FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARBON MONOXIDE; CARPINUS BETULUS FLOWERING TOP; ANHYDROUS CITRIC ACID; GELSEMIUM SEMPERVIRENS ROOT; BOS TAURUS HYPOTHALAMUS; POTASSIUM PHOSPHATE, DIBASIC; EGG PHOSPHOLIPIDS; SODIUM CHLORIDE; OLEA EUROPAEA FLOWER; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 55926-0012_24bcef55-2eac-4481-8f9c-9c92fd044caa 55926-0012 HUMAN OTC DRUG Serenity Remedy No. 12 Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Clematis erecta, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, sulphur, symphytum officinale, Veratrum album LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CLEMATIS RECTA FLOWERING TOP; CLEMATIS VITALBA FLOWER; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF; SULFUR; COMFREY ROOT; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 55926-0014_a7b74dcf-e09a-4384-98a0-48488432e353 55926-0014 HUMAN OTC DRUG Steady Remedy No. 14 Aconitum napellus, Alfalfa, Argentum nitricum, Arsenicum album, Aurum metallicum, Avena sativa, Baryta carbonica, Calcarea phosphorica, Chamomilla, Gelsemium sempervirens, Glonoinum, Humulus lupulus, Ignatia amara, Kali arsenicosum, Kali phosphoricum, Muriaticum acidum, Natrum phosphoricum, Passiflora incarnata, Phosphorus, Staphysagria, Stramonium LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ACONITUM NAPELLUS; ALFALFA; SILVER NITRATE; ARSENIC TRIOXIDE; GOLD; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; HOPS; STRYCHNOS IGNATII SEED; POTASSIUM ARSENITE ANHYDROUS; POTASSIUM PHOSPHATE, DIBASIC; HYDROCHLORIC ACID; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 55926-0015_57fbec61-a8ac-4595-b2f4-805c8c9eaac2 55926-0015 HUMAN OTC DRUG Slim Remedy No. 15 Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, flos, Anacardium orientale, Antimonium crudum, Calcarea carbonica, Castanea sativa, flos, Cortisone aceticum, Fucus vesiculosus, Hypothalamus, Kali bichromicum, Oleander, Pituitarum posterium, Sabadilla, Staphysagria, Thyroidinum LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC EPINEPHRINE; CORTICOTROPIN; AGRIMONIA EUPATORIA FLOWER; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CASTANEA SATIVA FLOWER; CORTISONE ACETATE; FUCUS VESICULOSUS; BOS TAURUS HYPOTHALAMUS; POTASSIUM DICHROMATE; NERIUM OLEANDER LEAF; SUS SCROFA PITUITARY GLAND; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 55926-0016_c836c281-33da-4a08-b43e-b569753cb7c0 55926-0016 HUMAN OTC DRUG Regular Remedies No. 16 Alumina, Bellis perennis, Causticum, Collinsonia canadensis, Hydrastis canadensis, Lac defloratum, Natrum muriaticum, Nux vomica, Plumbum metallicum, Sepia LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 55926-0017_6732e61f-34f6-4d5b-8d37-b77a51aacb2a 55926-0017 HUMAN OTC DRUG Control Remedy No. 17 Aloe socotrina, Chamomilla, Cinchona officinalis, Colocynthis, Crotontiglium, Cuprum arsenicosum, Gelsemium sempervirens, Ipecacuanha, Nux vomica, Phosphoricum acidum, Podophyllum peltatum Veratrum album LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 55926-0018_1620b3f8-60d1-4969-bef3-d8c01f2c5e26 55926-0018 HUMAN OTC DRUG Recharge Remedy No. 18 Alfalfa, Ambra grisea, Anacardium orientale, Argentum nitricum, Aurum metallicum, Avena sativa, Caladium seguinum, Calcarea carbonica, Cocculus indicus, Gelsemium sempervirens, Ignatia amara, Kali phosphoricum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Phosphoricum acidum, Phosphorus, Selenium metallicum, Sepia, Silicea, Sulphur LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ALFALFA; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 55926-0019_38b30db7-7ac2-49cf-b3c1-f99438c9ecf7 55926-0019 HUMAN OTC DRUG Morale Remedy No. 19 Anacardium orientale, Aurum metallicum, Calcarea carbonica, Cimicifuga racemosa, Hypericum perforatum, Ignatia amara, Kale bromatum, Natrum carbonicum, Natrum sulphuricum, Phosphoricum acidum, Phosphorus, Pulsatilla, Sepia, Tabacum LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC SEMECARPUS ANACARDIUM JUICE; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; BLACK COHOSH; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; SODIUM CARBONATE; SODIUM SULFATE; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 55926-0020_ab41e59d-245a-411a-9435-bd642bc852e6 55926-0020 HUMAN OTC DRUG Soothe Remedy No. 20 Belladonna, Bryonia, Capsicum annuum, Chininum arsenicosum, Coffea cruda, Gelsemium sempervirens, Glonoinum, Ignatia amara, Kali bichromicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia, Sulphur LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; QUININE ARSENITE; ARABICA COFFEE BEAN; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 55926-0021_cc3aa127-2458-432e-b39a-da36fb0ae417 55926-0021 HUMAN OTC DRUG Relieve Remedy No. 21 Apis mellifica, Chamomilla, Cimicifuga racemosa, Cyclamen europaeum, Helonias dioica, Ignatia amara, Lac caninum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Platinum metallicum, Sepia LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC APIS MELLIFERA; MATRICARIA RECUTITA; BLACK COHOSH; CYCLAMEN PURPURASCENS TUBER; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; CANIS LUPUS FAMILIARIS MILK; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PLATINUM; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 55926-0022_70e210fc-95c4-4f52-8445-4f4ac7ee2bcf 55926-0022 HUMAN OTC DRUG Invigorate Male Remedy No. 22 Agnus castus, Arnica montana, Baryta carbonica, Caladium seguinum, Kali bromatum, Lycopodium clavatum, Nuphar luteum, Nux vomica, Onosmodium virginianum, Phosphoricum acidum, Picricum acidum, Selenium metallicum LIQUID ORAL 20130717 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 55926-0023_067b4185-43ea-468b-8228-1a601ebd4e0c 55926-0023 HUMAN OTC DRUG Invigorate Female Remedy No. 23 Agnus castus, Aletris farinosa, Berberis vulgaris, Caulopyllum thalictroides, Ferrum metallicum, Graphites, Helonias dioica, Ignatia amara, Lilium tigrinum, Lycopodium clavatum, Natrum muriaticum, Onosmodium virginianum, Pulsatilla, Sepia LIQUID ORAL 20130722 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC CHASTE TREE; ALETRIS FARINOSA ROOT; BERBERIS VULGARIS ROOT BARK; CAULOPHYLLUM THALICTROIDES ROOT; IRON; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; ONOSMODIUM VIRGINIANUM WHOLE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 55926-0024_622c47c2-d8da-4618-bb7c-b76fea806848 55926-0024 HUMAN OTC DRUG EmuAid Silver OINTMENT TOPICAL 20140116 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC SILVER 10 [hp_X]/59mL N 20181231 55926-0025_b2339d13-de21-4b68-93e8-7ef2fa13bfed 55926-0025 HUMAN OTC DRUG emuaidMAX Silver OINTMENT TOPICAL 20140122 UNAPPROVED HOMEOPATHIC Speer Laboratories, LLC SILVER 10 [hp_X]/100mL N 20181231 55946-701_a97efbc6-c4c6-4bd9-a1eb-e20bca6cb9d4 55946-701 HUMAN OTC DRUG CALENDULA DIAPER RASH CREAM ZINC OXIDE CREAM TOPICAL 20130716 OTC MONOGRAPH FINAL part347 Weleda, Inc. ZINC OXIDE 12 g/100g E 20171231 55946-702_4dda595d-1798-4a38-af94-b1b1e588a1af 55946-702 HUMAN OTC DRUG WHITE MALLOW DIAPER RASH CREAM ZINC OXIDE CREAM TOPICAL 20140826 OTC MONOGRAPH FINAL part347 Weleda, Inc. ZINC OXIDE 14 g/100g E 20171231 55946-703_c6fb5235-3a83-4d46-8046-1fb63b4aa800 55946-703 HUMAN OTC DRUG CALENDULA DIAPER RASH ZINC OXIDE CREAM TOPICAL 20171206 OTC MONOGRAPH FINAL part347 Weleda, Inc. ZINC OXIDE 12 g/100g N 20181231 55959-132_5ade1cef-6576-4758-9a8b-6f7f06de82ea 55959-132 HUMAN OTC DRUG DoloMax Cold Cough Acetaminophen, Guaifenesin, Phenylephrine HCl, Dextromethorphan TABLET ORAL 20171201 OTC MONOGRAPH FINAL part341 BENARD INDUSTRIES INC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 325; 200; 5; 15 mg/1; mg/1; mg/1; mg/1 N 20191231 55981-7009_a36a4454-c36d-4644-84d8-0dd958217e0a 55981-7009 HUMAN OTC DRUG PRIME-CIDE ALCOHOL SOLUTION TOPICAL 19981201 OTC MONOGRAPH NOT FINAL part333A PREMIERE PRODUCTS INC ALCOHOL 75.85 mL/100mL E 20171231 55992-023_76022b1f-449d-418a-9065-47b565f9efa0 55992-023 HUMAN OTC DRUG DermaSana Miconazole Nitrate CREAM TOPICAL 20130214 OTC MONOGRAPH FINAL part333C OMG Medical Group, LLC MICONAZOLE NITRATE; TRICLOSAN 200; 30 mg/mg; mg/mg E 20171231 55992-404_d9a1c2da-0ecb-4fce-b846-e06133ccffa8 55992-404 HUMAN OTC DRUG PainMD Max Capsaicin, Histamine Dihydrocholoride CREAM TOPICAL 20140722 OTC MONOGRAPH NOT FINAL part348 OMG Medical Group, LLC CAPSAICIN; HISTAMINE DIHYDROCHLORIDE 3.75; 3.5 mg/mg; mg/mg E 20171231 55992-711_10c85210-171d-4786-bac7-29ff0e86a4cc 55992-711 HUMAN OTC DRUG Nail MD Miconazole Nitrate CREAM TOPICAL 20130214 OTC MONOGRAPH FINAL part333C OMG Medical Group, LLC MICONAZOLE NITRATE 200 mg/mg E 20171231 55992-717_83fb189b-4b17-42e9-b8f6-6ba95ac31796 55992-717 HUMAN OTC DRUG Nail MD Tolnafate, Triclosan SPRAY TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part333A OMG Medical Group, LLC TRICLOSAN; TOLNAFTATE 20; 100 mg/mg; mg/mg E 20171231 56001-400_aedb4c21-62f0-4256-afaf-28bce61df64c 56001-400 HUMAN OTC DRUG BB FAIR Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM, AUGMENTED TOPICAL 20130315 OTC MONOGRAPH FINAL part352 SAYB International AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 25; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 56001-401_aedb4c21-62f0-4256-afaf-28bce61df64c 56001-401 HUMAN OTC DRUG BB LIGHT Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM, AUGMENTED TOPICAL 20130315 OTC MONOGRAPH FINAL part352 SAYB International AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 25; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 56001-402_aedb4c21-62f0-4256-afaf-28bce61df64c 56001-402 HUMAN OTC DRUG BB MEDIUM Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM, AUGMENTED TOPICAL 20130315 OTC MONOGRAPH FINAL part352 SAYB International AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 25; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 56001-403_aedb4c21-62f0-4256-afaf-28bce61df64c 56001-403 HUMAN OTC DRUG BB DARK Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM, AUGMENTED TOPICAL 20130315 OTC MONOGRAPH FINAL part352 SAYB International AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 25; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 56062-001_a732f98f-6cdd-4bf9-aa74-f7ecb28803b2 56062-001 HUMAN OTC DRUG regular strength calcium carbonate TABLET, CHEWABLE ORAL 20151218 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 500 mg/1 N 20181231 56062-003_6e6fe1d8-ec3b-4a89-ab4e-d773bd26c669 56062-003 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20080917 OTC MONOGRAPH FINAL part333D Publix Super Markets SALICYLIC ACID 19.8 mg/g N 20181231 56062-004_f9d28d71-2f8b-408e-99a0-68e09209e492 56062-004 HUMAN OTC DRUG Anticavity Rinse Sodium Fluoride MOUTHWASH ORAL 20100226 OTC MONOGRAPH FINAL part355 Publix Super Markets, Inc., SODIUM FLUORIDE .2 mg/mL N 20191231 56062-005_f314a539-6df2-49c7-b265-8685455ae3bf 56062-005 HUMAN OTC DRUG pain relief acetaminophen CAPSULE, LIQUID FILLED ORAL 20160503 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 325 mg/1 N 20181231 56062-007_3583ad5a-7b1e-4346-9d7e-be91738e4d67 56062-007 HUMAN OTC DRUG nasoflow Fluticasone propionate SPRAY, METERED NASAL 20160531 ANDA ANDA207957 Publix Super Markets Inc FLUTICASONE PROPIONATE 50 ug/1 N 20181231 56062-013_24592af1-cef0-43fa-a42f-b1ce12dff181 56062-013 HUMAN OTC DRUG allergy relief d 12 hour Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20130509 ANDA ANDA076050 Publix Super Markets Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 56062-027_ee2c647f-4a2c-44e8-ac48-c6d008cb48af 56062-027 HUMAN OTC DRUG Aspirin Enteric Safety Coated Aspirin TABLET, COATED ORAL 20130815 OTC MONOGRAPH FINAL part343 Publix Supermarkets, Inc. ASPIRIN 81 mg/1 N 20181231 56062-041_bdf089ee-f3b0-4881-8218-7cfc9fa7140b 56062-041 HUMAN OTC DRUG Publix Cherry Flavor Nitetime acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090709 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 56062-050_d1d3a565-f3d2-4f39-889b-a99e67aee179 56062-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20110915 ANDA ANDA079113 Publix Super Markets Inc DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 56062-056_fc607ecb-73cb-4cf1-a1b0-e503eeb60c89 56062-056 HUMAN OTC DRUG nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20140217 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 56062-057_fb36243d-aace-4ada-bf40-14e9547d3d3d 56062-057 HUMAN OTC DRUG profen ib infants ibuprofen SUSPENSION ORAL 20010629 ANDA ANDA075217 Publix Super Markets Inc IBUPROFEN 50 mg/1.25mL N 20181231 56062-065_6915e23d-a1ca-4fea-b383-eefc8a00a093 56062-065 HUMAN OTC DRUG extra moisturizing Oxymetazoline HCl SPRAY NASAL 19980507 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 56062-069_7e325c4f-f4e2-47fc-a389-e3cdd7c33f80 56062-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20090113 OTC MONOGRAPH FINAL part347 Publix Super Markets, Inc PETROLATUM 1 g/g N 20181231 56062-071_791eabfc-b8b8-4416-9202-b7d68350d773 56062-071 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20160731 OTC MONOGRAPH FINAL part335 Publix Supermarkets, Inc. BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 56062-072_9ac4be4e-687f-4fb9-93cb-c6f79b969121 56062-072 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19980106 OTC MONOGRAPH NOT FINAL part356 Publix Super Markets EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 56062-074_66ddf999-aa22-4503-a683-33c511607d75 56062-074 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 20060322 ANDA ANDA077349 Publix Super Markets Inc IBUPROFEN 200 mg/1 N 20181231 56062-080_e8b86950-406e-4f21-871c-f441b4c85c79 56062-080 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Publix Super Markets Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 56062-081_9dcb4ab3-b07b-4bdc-8c71-c8f9f40137ec 56062-081 HUMAN OTC DRUG miconazole 3 day Miconazole nitrate KIT 20090626 ANDA ANDA075329 Publix Super Markets Inc N 20181231 56062-090_0a6891a2-119f-40ab-a395-093fdf05a385 56062-090 HUMAN OTC DRUG daytime pe nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20110516 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc N 20181231 56062-090_427fd65e-155c-4e02-99e7-f90774d819ff 56062-090 HUMAN OTC DRUG daytime pe nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20121029 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc N 20181231 56062-090_cd2380a6-e7b3-4ad1-9f2b-f97718553e0e 56062-090 HUMAN OTC DRUG daytime pe nitetime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20081015 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc N 20181231 56062-092_c5c03e83-4e52-4fd8-8469-2967fbf1b35c 56062-092 HUMAN OTC DRUG childrens allergy Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Publix Super Markets Inc LORATADINE 5 mg/5mL N 20181231 56062-094_7bd2fab3-5c0e-4ffc-b23f-c2546b00607a 56062-094 HUMAN OTC DRUG nasal decongestant pe non drowsy Phenylephrine Hydrochloride TABLET ORAL 20050610 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 56062-099_50582666-d6b9-45b8-9c94-fc0301113907 56062-099 HUMAN OTC DRUG heartburn relief Ranitidine TABLET, FILM COATED ORAL 20160523 ANDA ANDA091429 Publix Super Markets Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 56062-102_3cb369c4-0a05-451c-b719-7860a25aab48 56062-102 HUMAN OTC DRUG childrens allergy Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Publix Super Markets Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 56062-106_5871cf17-af3f-457e-9765-04167992dc43 56062-106 HUMAN OTC DRUG Childrens Allergy Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Publix Super Markets Inc CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 56062-107_13b318fb-aaa1-45ab-a288-75159151bcae 56062-107 HUMAN OTC DRUG allergy relief nasal Fluticasone propionate SPRAY, METERED NASAL 20160908 ANDA ANDA207957 Publix Super Markets Inc FLUTICASONE PROPIONATE 50 ug/1 N 20191231 56062-117_0b4e4363-1c50-4a94-8db6-4a1403ae4017 56062-117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120810 ANDA ANDA202319 Publix Super Markets Inc LANSOPRAZOLE 15 mg/1 N 20181231 56062-121_ffd7feec-8b98-4aac-8803-50e7c7df39aa 56062-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120703 ANDA ANDA202300 Publix Supermarkets, Inc. IBUPROFEN 200 mg/1 N 20181231 56062-122_253f58f4-d3e1-404b-b094-dae0456f2996 56062-122 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120703 ANDA ANDA202300 Publix Supermarkets, Inc. IBUPROFEN 200 mg/1 N 20181231 56062-131_d3010272-1961-4b73-9b9e-48b44c8ebf5d 56062-131 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170802 ANDA ANDA203599 Publix Super Markets Inc IBUPROFEN 200 mg/1 N 20191231 56062-132_07165ae7-d62a-4eda-b096-0236672a4f12 56062-132 HUMAN OTC DRUG childrens allergy Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Publix Super Markets Inc LORATADINE 5 mg/5mL N 20191231 56062-141_02436e57-65fb-45a4-b712-c4a6e9317e73 56062-141 HUMAN OTC DRUG acid reducer Famotidine TABLET ORAL 20091123 ANDA ANDA075400 Publix Super Markets Inc FAMOTIDINE 10 mg/1 N 20181231 56062-144_5d2db820-28f6-4daf-8fe6-56485376eaba 56062-144 HUMAN OTC DRUG Mucus D ER Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20160623 ANDA ANDA091071 Publix Super Markets Inc GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 56062-153_a4ff29f2-543d-400a-9761-0c7786a12bd1 56062-153 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090113 OTC MONOGRAPH FINAL part358H Publix Super Markets, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 56062-160_a8b1f7e9-78cf-4631-9375-938d5abb0fda 56062-160 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine hcl SUPPOSITORY RECTAL 20121220 OTC MONOGRAPH FINAL part346 Publix Super Markets Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2.135; .0065 g/2.5g; g/2.5g N 20181231 56062-161_76fae501-8e5d-4cf0-9999-e2a537677efe 56062-161 HUMAN OTC DRUG Pain Relief Acetaminophen SUSPENSION ORAL 20111129 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 160 mg/5mL N 20181231 56062-163_3a789d09-02d6-40b2-9f84-11daa9593b9b 56062-163 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20110720 OTC MONOGRAPH FINAL part355 Publix Super Markets, Inc SODIUM FLUORIDE 1 mg/mL N 20181231 56062-166_405c9e8b-627f-432b-aa95-d899a26bf233 56062-166 HUMAN OTC DRUG profen ib Ibuprofen SUSPENSION ORAL 20031118 ANDA ANDA074937 Publix Super Markets Inc IBUPROFEN 100 mg/5mL N 20181231 56062-174_9892ba45-7c2d-4937-9dc6-76aaef8596c7 56062-174 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20150630 NDA NDA021920 Publix Supermarkets, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 56062-175_74601be6-b8f5-4135-a6d3-9cc5f53ef9ea 56062-175 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 20030828 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 160 mg/5mL N 20181231 56062-176_df7e89dd-f0ab-4103-891b-13bad520f669 56062-176 HUMAN OTC DRUG Allergy Relief D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20100311 ANDA ANDA077170 Publix Super Markets Inc CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 56062-179_e7a973e8-3a54-4fc2-87a6-93e514e2b076 56062-179 HUMAN OTC DRUG extra strength antacid calcium supplement Calcium carbonate TABLET, CHEWABLE ORAL 20020521 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 750 mg/1 N 20181231 56062-184_8e4ec9ab-fbca-43ca-ae3b-9f0a70ddc693 56062-184 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20120619 OTC MONOGRAPH NOT FINAL part343 Publix Supermarkets, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 56062-187_29adb2cc-9856-4a4a-a716-651aea37c2ca 56062-187 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET, COATED ORAL 19950206 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 500 mg/1 N 20181231 56062-188_ba9785ed-7ffc-4bd0-93e9-037897e8c295 56062-188 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131202 OTC MONOGRAPH FINAL part346 Publix Super Markets Inc MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 56062-194_493bc4f5-e855-497b-b52e-20801b62fdc7 56062-194 HUMAN OTC DRUG maximum strength Famotidine TABLET ORAL 20071203 ANDA ANDA077351 Publix Super Markets Inc FAMOTIDINE 20 mg/1 N 20181231 56062-199_769f5389-d11e-412e-a948-3772705b5993 56062-199 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20130430 ANDA ANDA078682 Publix Supermarkets, Inc. IBUPROFEN 200 mg/1 N 20181231 56062-202_638755d2-d49c-4ae6-abb5-fc3a91f874fb 56062-202 HUMAN OTC DRUG minoxidil for women minoxidil SOLUTION TOPICAL 20110404 ANDA ANDA075357 Publix Super Markets Inc MINOXIDIL 2 g/100mL N 20181231 56062-204_8bb0e036-6f17-4440-8257-7e80df738aac 56062-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Publix Super Markets Inc PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 56062-205_7fe041ea-88bd-4ceb-a081-6fc9c5d3a4b2 56062-205 HUMAN OTC DRUG Therapeutic T Plus Coal Tar SHAMPOO TOPICAL 20071012 OTC MONOGRAPH FINAL part358H Publix Super Markets, Inc. COAL TAR 25 mg/mL N 20181231 56062-211_7f18fa04-5ce6-45a6-8eab-e52ff8ca3e02 56062-211 HUMAN OTC DRUG Allergy Relief Cetirizine HCl CAPSULE, LIQUID FILLED ORAL 20150131 NDA NDA022429 Publix Supermarkets, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 56062-213_7161c1e2-61fe-4b9c-828c-801f5c13799a 56062-213 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20070819 OTC MONOGRAPH FINAL part355 Publix Super Markets, Inc SODIUM FLUORIDE .05 kg/100L N 20181231 56062-224_5e1fd033-3c8a-430a-be91-b7d0e807b5b8 56062-224 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030319 ANDA ANDA075232 Publix Super Markets Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20191231 56062-227_efae7b6a-7271-4a8f-bc9d-8540a63b8328 56062-227 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, COATED ORAL 20071126 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 500 mg/1 N 20181231 56062-247_371203f0-dd35-4300-bff1-aaf9672ae168 56062-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140530 OTC MONOGRAPH NOT FINAL part343 Publix Supermarkets, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 56062-255_e565fa8f-721c-4c52-8ee0-85ba16601144 56062-255 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20110909 ANDA ANDA075217 Publix Super Markets Inc IBUPROFEN 50 mg/1.25mL N 20181231 56062-259_c1bfdd5f-9630-435c-986c-6fb0685a6da2 56062-259 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19990702 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ASPIRIN 81 mg/1 N 20181231 56062-272_8f22d47c-e754-4691-8b78-a25d69cc034d 56062-272 HUMAN OTC DRUG sinus relief non drowsy Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20071126 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 56062-274_88b0d897-b93f-42c3-88d0-784dd6c555e4 56062-274 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19980824 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ASPIRIN 81 mg/1 N 20181231 56062-279_61575f7d-c841-4022-9f3a-0d019c6c429e 56062-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140908 OTC MONOGRAPH FINAL part346 Publix Super Markets Inc COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 56062-281_6250ce02-f99b-4516-ab81-2b88a685d774 56062-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090113 OTC MONOGRAPH FINAL part358H Publix PYRITHIONE ZINC 10.4 mg/mL N 20181231 56062-282_1257b2e0-4ae6-4aab-b1f3-c93fd70116c6 56062-282 HUMAN OTC DRUG dayhist allergy Clemastine fumarate TABLET ORAL 19961120 ANDA ANDA074512 Publix Super Markets Inc CLEMASTINE FUMARATE 1.34 mg/1 N 20181231 56062-288_bced882d-b8f4-4851-8943-7b16b7cc8df0 56062-288 HUMAN OTC DRUG childrens mucus relief Guaifenesin LIQUID ORAL 20121214 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc GUAIFENESIN 100 mg/5mL N 20181231 56062-294_7c0efeb4-9212-41d7-a617-7310fe7aa9e8 56062-294 HUMAN OTC DRUG minoxidil foam Minoxidil AEROSOL, FOAM TOPICAL 20130617 ANDA ANDA091344 Publix Super Markets Inc MINOXIDIL 5 g/100g N 20181231 56062-299_06bacc7a-e5ff-443c-87ec-4bf946664e68 56062-299 HUMAN OTC DRUG Zestymint Antiseptic cetylpyridinium chloride MOUTHWASH ORAL 20080506 OTC MONOGRAPH NOT FINAL part356 Publix Super Markets, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 56062-302_c187e324-9b42-4049-9737-fe15d2ba70d1 56062-302 HUMAN OTC DRUG original formula stomach relief Bismuth subsalicylate LIQUID ORAL 19950329 OTC MONOGRAPH FINAL part335 Publix Super Markets Inc BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 56062-304_377b8cc5-3567-4593-b62f-9ac70565e3d5 56062-304 HUMAN OTC DRUG original oxymetazoline hydrochloride SPRAY NASAL 19911113 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 56062-306_0e6beb4e-1e85-4593-93cb-7540eeef639c 56062-306 HUMAN OTC DRUG clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091214 ANDA ANDA090685 Publix Super Markets Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 56062-308_1a77d8ef-8277-44b8-9203-e175c2af827e 56062-308 HUMAN OTC DRUG severe cold multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20090226 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 56062-310_e46aa200-8cf3-430d-b511-db72c4d5e6d6 56062-310 HUMAN OTC DRUG tussin expectorant for adults Guaifenesin SOLUTION ORAL 20040213 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc GUAIFENESIN 200 mg/10mL N 20181231 56062-311_9aab2330-b6ce-43be-98a9-b299f8e4c5d3 56062-311 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20101005 OTC MONOGRAPH FINAL part358H Publix PYRITHIONE ZINC 10 mg/mL N 20181231 56062-318_b8b63bf4-e2fe-4b3b-bf29-75ae8edabc16 56062-318 HUMAN OTC DRUG Original Antiseptic Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 19910611 OTC MONOGRAPH NOT FINAL part356 Publix EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 56062-319_ea0e710b-b56d-4306-bbca-5fe10e05ee5c 56062-319 HUMAN OTC DRUG severe cold and flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20150408 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 56062-321_c5654c5a-d438-4c25-ba80-a183ead0aa4f 56062-321 HUMAN OTC DRUG dual action famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20081205 ANDA ANDA077355 Publix Super Markets Inc FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 56062-332_7f00e15f-8361-4ba8-ac94-11371bb3e032 56062-332 HUMAN OTC DRUG mint milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19940902 OTC MONOGRAPH NOT FINAL part334 Publix Super Markets Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 56062-334_7401e61f-2fe2-4ef1-88b3-4e95855af0e9 56062-334 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20170228 OTC MONOGRAPH NOT FINAL part334 Publix Supermarkets, Inc. MINERAL OIL 100 mg/100mL N 20181231 56062-335_b53354bf-02f0-4679-8f15-360a48f6116e 56062-335 HUMAN OTC DRUG Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20111121 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 56062-344_42b2f4e1-1561-480f-9c23-bd99655aedc6 56062-344 HUMAN OTC DRUG stop smoking aid Nicotine Polacrilex LOZENGE ORAL 20060412 ANDA ANDA077007 Publix Super Markets Inc NICOTINE 2 mg/1 N 20181231 56062-357_c5ae5d7e-80fe-4d10-9249-2ca8512519a7 56062-357 HUMAN OTC DRUG Regular Strength antacid anti gas Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 19940912 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 56062-359_b1c03fd7-a627-4b52-af5f-ee77dbf1968b 56062-359 HUMAN OTC DRUG Tussin DM Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20140210 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 56062-368_e64c66ff-95fe-4983-895a-a6feae0c01b7 56062-368 HUMAN OTC DRUG All Day Relief Naproxen Sodium TABLET, FILM COATED ORAL 19971229 ANDA ANDA074661 Publix Super Markets Inc NAPROXEN SODIUM 220 mg/1 N 20181231 56062-370_07f6efce-2a99-43dc-98f6-d58e6cda1baf 56062-370 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A Publix Super Markets, Inc., ALCOHOL 70 mL/100mL N 20181231 56062-371_dc462032-45ba-4c79-8739-10ce074f67a2 56062-371 HUMAN OTC DRUG cold relief multi symptom Acetaminophen, Dextromethorphan hbr, Phenylephrine hcl TABLET, FILM COATED ORAL 20150921 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 56062-372_05b1a38f-011d-4389-9718-452effd36b80 56062-372 HUMAN OTC DRUG Stomach Relief Original Formula Bismuth subsalicylate LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part335 Publix Supermarkets, Inc. BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 56062-374_de8ca9cd-b86d-4eb1-a4eb-6ca7b5fb28ad 56062-374 HUMAN OTC DRUG migraine relief Acetaminophen, Aspirin, Caffeine TABLET ORAL 20021226 ANDA ANDA075794 Publix Super Markets Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 56062-376_ffd4a806-d95e-4556-b5b9-014f2464981a 56062-376 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140930 OTC MONOGRAPH NOT FINAL part356 Publix Supermarkets, Inc. PHENOL 1.4 g/100mL N 20181231 56062-377_63650ae3-175b-49ea-9b8f-0fd0fb933be9 56062-377 HUMAN OTC DRUG Sore Throat Menthol Phenol SPRAY ORAL 20140930 OTC MONOGRAPH NOT FINAL part356 Publix Supermarkets, Inc. PHENOL 1.4 g/100mL N 20181231 56062-379_aa889461-12a9-45c4-871a-806c81d3ab02 56062-379 HUMAN OTC DRUG Childrens Allergy Diphenhydramine HCl SOLUTION ORAL 20140211 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 56062-384_fd79b7ac-7d2e-47ff-9ff7-3509ef0cf856 56062-384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20140225 ANDA ANDA091135 Publix Super Markets Inc DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 56062-388_78a1f832-1040-4b25-8c67-d582ad6abf84 56062-388 HUMAN OTC DRUG no drip Oxymetazoline HCl SPRAY NASAL 20021226 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 56062-396_ab070a99-7011-4d74-b953-882b2bd3a17d 56062-396 HUMAN OTC DRUG Original Magnesium hydroxide SUSPENSION ORAL 19940902 OTC MONOGRAPH NOT FINAL part334 Publix Super Markets Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 56062-403_8678d1ae-4c8a-4673-b6e7-7caf258933d3 56062-403 HUMAN OTC DRUG Hand wash Benzalkonium chloride SOAP TOPICAL 20150123 OTC MONOGRAPH NOT FINAL part333A Publix Super Markets BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 56062-404_c6195974-f925-4b25-9f24-7fa12ee4ea48 56062-404 HUMAN OTC DRUG profen ib Ibuprofen SUSPENSION/ DROPS ORAL 20150219 ANDA ANDA075217 Publix Super Markets Inc IBUPROFEN 50 mg/1.25mL N 20181231 56062-409_f6993bc5-550c-42b5-aee3-60f08302360a 56062-409 HUMAN OTC DRUG stay awake Caffeine TABLET ORAL 19980106 OTC MONOGRAPH FINAL part340 Publix Super Markets Inc CAFFEINE 200 mg/1 N 20181231 56062-416_5a1f6e47-f72f-43df-8d7a-ddef24dd9080 56062-416 HUMAN OTC DRUG aspirin Aspirin TABLET ORAL 19880915 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ASPIRIN 325 mg/1 N 20181231 56062-423_ea1212c0-ea76-499b-8df6-0bf6ff60cdc7 56062-423 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Publix Super Markets Inc IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 56062-428_0202daa0-aef4-416b-a942-3c359f3b1bd1 56062-428 HUMAN OTC DRUG Nicotine Polacrilex Coated Mint Nicotine Polacrilex GUM, CHEWING BUCCAL 20140101 ANDA ANDA078699 Publix NICOTINE 2 mg/1 N 20181231 56062-429_0202daa0-aef4-416b-a942-3c359f3b1bd1 56062-429 HUMAN OTC DRUG Nicotine Polacrilex Coated Mint Nicotine Polacrilex GUM, CHEWING BUCCAL 20140101 ANDA ANDA078697 Publix NICOTINE 4 mg/1 N 20181231 56062-431_f23ffbef-6cce-4dc5-aa3c-814af43dc236 56062-431 HUMAN OTC DRUG sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20010724 OTC MONOGRAPH FINAL part338 Publix Super Markets Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 56062-432_c8cf6549-b568-404c-af44-51cbf6052099 56062-432 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19930909 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 56062-434_6d0803ef-7870-4504-90c9-8c411a698a05 56062-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130822 OTC MONOGRAPH NOT FINAL part356 Publix Super Markets EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 56062-437_ea1940de-d48d-43c7-854b-42a02b88b3c9 56062-437 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19930922 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 56062-440_45abf518-36cb-4c85-bca1-c318ca8e5987 56062-440 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, COATED ORAL 20130104 OTC MONOGRAPH FINAL part343 Publix Supermarkets, Inc. ASPIRIN 81 mg/1 N 20181231 56062-445_b4166579-f057-4942-93fd-73ff378b02b6 56062-445 HUMAN OTC DRUG flu and severe cold and cough Acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20140313 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 56062-459_5d3161eb-952f-46af-816e-9be13c337ac1 56062-459 HUMAN OTC DRUG nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20111107 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 56062-461_710aba07-3a81-47ab-89fb-3b4427468960 56062-461 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20041028 ANDA ANDA076359 Publix Super Markets Inc IBUPROFEN 100 mg/1 N 20181231 56062-462_bf2375c4-fc3a-46b1-8565-d5bcc667fca5 56062-462 HUMAN OTC DRUG allergy diphenhydramine hydrochloride CAPSULE ORAL 19930831 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 56062-467_a49686c1-9edc-4fc9-ac09-83c242b93fa1 56062-467 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19990702 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ASPIRIN 81 mg/1 N 20181231 56062-468_26b32269-5984-46ea-bd02-f4a25d0470bb 56062-468 HUMAN OTC DRUG extra strength Calcium carbonate TABLET, CHEWABLE ORAL 20020509 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 750 mg/1 N 20181231 56062-469_d70593ec-a826-41d7-a823-f9fefc7c47a2 56062-469 HUMAN OTC DRUG chewable Bismuth subsalicylate TABLET, CHEWABLE ORAL 20010315 OTC MONOGRAPH FINAL part335 Publix Super Markets Inc BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 56062-475_b73c947f-9fde-4f55-bfcd-235bd68d49fa 56062-475 HUMAN OTC DRUG childrens allergy Cetirizine HCl SOLUTION ORAL 20151221 ANDA ANDA204226 Publix Super Markets Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 56062-478_096f9056-9c41-440f-b624-5e6afe71de3c 56062-478 HUMAN OTC DRUG regular strength calcium carbonate TABLET, CHEWABLE ORAL 19941011 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 500 mg/1 N 20181231 56062-479_532a5fa9-6b7a-4059-a1af-7c51466cf25e 56062-479 HUMAN OTC DRUG allergy Diphenhydramine Hydrochloride TABLET ORAL 19980507 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 56062-484_b1e3d62e-c39b-406d-b451-817d85be1de9 56062-484 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 19880915 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 500 mg/1 N 20181231 56062-485_9cf1d5dd-aa7d-46fc-8bd2-583b5a2c3ab3 56062-485 HUMAN OTC DRUG Regular Strength Antacid Calcium Supplement calcium carbonate TABLET, CHEWABLE ORAL 19940902 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 500 mg/1 N 20181231 56062-489_ab9fe6fb-c10e-4869-8d4b-ffe1f2b05846 56062-489 HUMAN OTC DRUG extra strength Calcium carbonate TABLET, CHEWABLE ORAL 20020521 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 750 mg/1 N 20181231 56062-490_e716f4b0-c94a-44a4-a819-7985bf7d9e5b 56062-490 HUMAN OTC DRUG all day relief Naproxen Sodium TABLET ORAL 19971229 ANDA ANDA074661 Publix Super Markets Inc NAPROXEN SODIUM 220 mg/1 N 20181231 56062-498_a8a6a59a-574d-4444-97f6-ffef1812e37f 56062-498 HUMAN OTC DRUG Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130325 ANDA ANDA078912 Publix Super Markets Inc GUAIFENESIN 600 mg/1 N 20181231 56062-500_112c5fac-8ca3-4199-b6e9-c0af58ccbc72 56062-500 HUMAN OTC DRUG severe cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, COATED ORAL 20140519 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 56062-503_5113d70c-567f-4dc3-a297-01b184f57778 56062-503 HUMAN OTC DRUG Nicotine Polacrilex Coated Fruit Nicotine Polacrilex GUM, CHEWING BUCCAL 20140101 ANDA ANDA079044 Publix NICOTINE 2 mg/1 N 20181231 56062-504_5113d70c-567f-4dc3-a297-01b184f57778 56062-504 HUMAN OTC DRUG Nicotine Polacrilex Coated Fruit Nicotine Polacrilex GUM, CHEWING BUCCAL 20140101 ANDA ANDA079038 Publix NICOTINE 4 mg/1 N 20181231 56062-516_c7ab5bb7-344e-4eb5-9b99-04a70b424f7d 56062-516 HUMAN OTC DRUG Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 19930319 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 56062-517_26aded93-0976-4892-8eae-edb875e7e430 56062-517 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060503 ANDA ANDA077349 Publix Super Markets Inc IBUPROFEN 200 mg/1 N 20181231 56062-525_54b54513-8250-4865-bb18-66260c508954 56062-525 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20170331 OTC MONOGRAPH NOT FINAL part343 Publix Supermarkets, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 56062-526_fba0b636-da83-40bc-8b42-cac904d65edd 56062-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Publix Super Markets Inc LORATADINE 10 mg/1 N 20181231 56062-535_3b146a9c-d098-4b2e-b547-c78742f021cb 56062-535 HUMAN OTC DRUG Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20010315 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ASPIRIN 81 mg/1 N 20181231 56062-544_e41de2d1-89ee-4b2a-a446-4f5098ad8dd3 56062-544 HUMAN OTC DRUG arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071126 ANDA ANDA075077 Publix Super Markets Inc ACETAMINOPHEN 650 mg/1 N 20181231 56062-571_1d5d5197-cb33-4f42-a406-a4850d0d00b8 56062-571 HUMAN OTC DRUG allergy relief fexofenadine hcl TABLET, FILM COATED ORAL 20120130 ANDA ANDA076447 Publix Super Markets Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 56062-580_a183c66b-529c-4ff8-9151-9615b0475dc2 56062-580 HUMAN OTC DRUG Daytime PE Nitetime Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20140707 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc N 20181231 56062-588_5610473c-c559-4690-8ddc-dbd1e3e8765c 56062-588 HUMAN OTC DRUG Maximum Strength Antacid Anti Gas Aluminum Hydroxide, Magnesium Hydroxide, Simethicone SUSPENSION ORAL 20071126 OTC MONOGRAPH FINAL part332 Publix Super Markets Inc ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 56062-590_3db39cb7-21df-49cc-8941-49b96dce0903 56062-590 HUMAN OTC DRUG pain relief acetaminophen SUSPENSION ORAL 20111230 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 160 mg/5mL N 20181231 56062-595_73bcc027-913a-4395-9f26-89203410d44b 56062-595 HUMAN OTC DRUG maximum strength Calcium Carbonate TABLET, CHEWABLE ORAL 20020429 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 1000 mg/1 N 20181231 56062-600_50306ac3-5702-4649-9e09-53aeaea89665 56062-600 HUMAN OTC DRUG ultrastrength Calcium Carbonate TABLET, CHEWABLE ORAL 20140730 OTC MONOGRAPH FINAL part331 Publix Super Markets Inc CALCIUM CARBONATE 1000 mg/1 N 20181231 56062-602_38eb53e1-f988-4434-81b7-4d0c9c2544c7 56062-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20140905 OTC MONOGRAPH NOT FINAL part334 Publix Super Markets, Inc MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 56062-604_385a1b5e-5d19-4e53-b683-0c7a4c8e501d 56062-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880915 ANDA ANDA072096 Publix Super Markets Inc IBUPROFEN 200 mg/1 N 20181231 56062-608_f0a2f357-7135-4a6e-b717-61f1572f30bd 56062-608 HUMAN OTC DRUG Nicotine Polacrilex Original Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20140101 ANDA ANDA074507 Publix NICOTINE 2 mg/1 N 20181231 56062-609_f0a2f357-7135-4a6e-b717-61f1572f30bd 56062-609 HUMAN OTC DRUG Nicotine Polacrilex Origianl Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 20140101 ANDA ANDA074707 Publix NICOTINE 4 mg/1 N 20181231 56062-616_88e835a3-11fd-4f19-8f8c-0eb5c3177116 56062-616 HUMAN OTC DRUG allergy sinus PE Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20141029 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 56062-619_e128b848-6b7e-486d-927c-2bcd64fb7dec 56062-619 HUMAN OTC DRUG Daily Moisturizing Dimethicone LOTION TOPICAL 19930319 OTC MONOGRAPH FINAL part347 Publix Super Markets Inc DIMETHICONE 1.3 kg/100mL N 20181231 56062-647_e41e0d2a-a6bd-4417-895f-7a22f49a844c 56062-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 19880915 ANDA ANDA072096 Publix Super Markets Inc IBUPROFEN 200 mg/1 N 20181231 56062-648_5822c47f-ab1f-45d2-bf17-724d9e5e424f 56062-648 HUMAN OTC DRUG Nasal Four Phenylephrine hydrochloride SPRAY NASAL 20030103 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 56062-650_9dbfb909-90d8-4f72-b46c-fde26263b09b 56062-650 HUMAN OTC DRUG rapid release pain relief Acetaminophen TABLET, FILM COATED ORAL 20160325 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN 500 mg/1 N 20181231 56062-656_58750a23-0fd5-4d5a-ad08-80cc06678d8d 56062-656 HUMAN OTC DRUG day time non drowsy acetaminophen, dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20060608 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 56062-657_aafa7da9-53d7-478a-805e-e68cdf54ed2b 56062-657 HUMAN OTC DRUG Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20031118 OTC MONOGRAPH FINAL part332 Publix Super Markets Inc DIMETHICONE 180 mg/1 N 20181231 56062-664_b5848e45-f2f4-4fbe-afae-6414cb87d5f0 56062-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19940330 OTC MONOGRAPH NOT FINAL part356 Publix Super Markets, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 56062-668_c8d28d08-d7b6-4cd0-a28c-dcbd2c747486 56062-668 HUMAN OTC DRUG NIGHTTIME cough Dextromethorphan Hydrobromide, Doxylamine Succinate SOLUTION ORAL 20030120 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 56062-700_9654554a-5355-4595-abe7-24790dd97307 56062-700 HUMAN OTC DRUG Publix Sunscreen SPF 15 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g N 20181231 56062-701_1721cec1-8510-46e5-9bfd-7a2a6fb130e9 56062-701 HUMAN OTC DRUG Publix Burn Relief LIDOCAINE HCL GEL TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part348 Publix Super Markets Inc LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 56062-702_6214883e-cf1e-42fe-8d14-4097079fb531 56062-702 HUMAN OTC DRUG Publix Burn Relief LIDOCAINE HCL GEL TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part348 Publix Super Markets Inc LIDOCAINE; MENTHOL .5; .1 g/100g; g/100g N 20181231 56062-703_0aa826db-deb0-46d1-95cc-b4e1eae89fe8 56062-703 HUMAN OTC DRUG Publix SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 56062-704_82230e7f-64eb-4f26-ac62-fac5b635db2f 56062-704 HUMAN OTC DRUG Publix Baby SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 56062-705_07b39def-10e4-4b10-a56b-1b3212a00896 56062-705 HUMAN OTC DRUG Publix Kids SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 56062-706_f460e104-3c21-472e-99a8-466d98844037 56062-706 HUMAN OTC DRUG Publix Kids AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 56062-707_4b93d386-75d7-4e0f-87e3-015826bcd2f9 56062-707 HUMAN OTC DRUG Publix Sport SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121114 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 56062-708_5d8f00b9-9947-4476-a8f0-dc3c30161b49 56062-708 HUMAN OTC DRUG Publix SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 56062-709_26298a56-08de-49c4-bd2f-45a29d9aa918 56062-709 HUMAN OTC DRUG Publix SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130716 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 56062-711_ee564f46-20b1-42a1-9544-18ad42c243dd 56062-711 HUMAN OTC DRUG Publix Burn Relief ALOE VERA LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part348 Publix Super Markets Inc LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 56062-712_32232d74-7842-4ea4-aabd-d4f95f11c1ed 56062-712 HUMAN OTC DRUG Publix SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20130716 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 4; 4; 5 g/100g; g/100g; g/100g; g/100g; 1/100g N 20181231 56062-713_afdac898-5b73-408b-8c82-71c8f63b5238 56062-713 HUMAN OTC DRUG Publix SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130716 OTC MONOGRAPH NOT FINAL part352 Publix Super Markets Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g N 20181231 56062-724_d855ae80-da98-4a5c-8e82-237879a615d1 56062-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Publix Super Markets Inc LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 56062-747_5a21d75a-d768-4f1f-a79d-8ad192a0d192 56062-747 HUMAN OTC DRUG Aloe Vera Gel Lidocaine HCl, Menthol GEL TOPICAL 20170110 OTC MONOGRAPH NOT FINAL part348 Publix Super Markets, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 7; 2 mg/mL; mg/mL N 20181231 56062-798_ea4130ad-0a89-4d60-af11-849fe261b158 56062-798 HUMAN OTC DRUG Minoxidil Minoxidil SOLUTION TOPICAL 20101025 ANDA ANDA075598 Publix Super Markets Inc MINOXIDIL 3 g/60mL N 20181231 56062-804_ff6e6de6-1929-4fd0-9b01-ecefdf4e20c9 56062-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20130322 OTC MONOGRAPH NOT FINAL part333A Publix Super Markets, Inc ISOPROPYL ALCOHOL .91 mg/mL N 20181231 56062-810_37679a7f-daf6-4852-ab7b-53ed755004e0 56062-810 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20130322 OTC MONOGRAPH NOT FINAL part333A Publix Super Markets, Inc ISOPROPYL ALCOHOL .7 mg/mL N 20181231 56062-822_7e729961-868a-49ff-a1aa-ce3ab84d0b9c 56062-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20160623 OTC MONOGRAPH FINAL part347 Publix Super Markets, Inc WITCH HAZEL 841 mg/mL N 20181231 56062-826_5fbc4665-d9cb-4785-b066-4f74a4bdec9a 56062-826 HUMAN OTC DRUG Publix Alcohol Isopropyl Alcohol SWAB TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part333A lix Super Markets Inc ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 56062-837_167c5f03-5607-45a9-8183-1796147a2df5 56062-837 HUMAN OTC DRUG pain relief pm extra strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20080710 OTC MONOGRAPH NOT FINAL part343 Publix Super Markets Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 56062-852_a2c8c2f5-bae2-45e4-9610-66d8f62547ad 56062-852 HUMAN OTC DRUG maximum strength ranitidine Ranitidine TABLET, FILM COATED ORAL 20131125 ANDA ANDA091429 Publix Super Markets Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 56062-871_4addf351-b28d-4dfe-84a4-9b5ac64fae97 56062-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20021107 OTC MONOGRAPH NOT FINAL part333A Publix Super Markets, Inc HYDROGEN PEROXIDE 30 mg/mL N 20181231 56062-873_9b76b88c-69a2-4e74-9aeb-0f9d415f89d9 56062-873 HUMAN OTC DRUG stop smoking aid Nicotine Polacrilex LOZENGE ORAL 20060412 ANDA ANDA077007 Publix Super Markets Inc NICOTINE 4 mg/1 N 20181231 56062-897_4922da7f-7e78-4f9d-98b9-3fc82cdd0a68 56062-897 HUMAN OTC DRUG profen IB childrens Ibuprofen SUSPENSION ORAL 20010913 ANDA ANDA074937 Publix Super Markets Inc IBUPROFEN 100 mg/5mL N 20181231 56062-898_60554fd6-96d5-4e73-b676-332116caa800 56062-898 HUMAN OTC DRUG Esomeprazole Magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170929 ANDA ANDA207193 Publix Super Markets Inc ESOMEPRAZOLE 20 mg/1 N 20181231 56062-906_3245487a-195c-49b6-b97b-95a1de296136 56062-906 HUMAN OTC DRUG Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate SOLUTION ORAL 20140211 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 56062-909_8e571871-2e69-4997-acfd-9ad39f61fad5 56062-909 HUMAN OTC DRUG All Day Moisture Octinoxate, Zinc Oxide LOTION TOPICAL 20160317 OTC MONOGRAPH FINAL part352 Publix OCTINOXATE; ZINC OXIDE 61.2; 30.6 mg/mL; mg/mL N 20181231 56062-915_90f50051-c99a-41a9-b1d0-e2a538e0fa23 56062-915 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080512 NDA NDA022032 Publix Super Markets Inc OMEPRAZOLE 20 mg/1 N 20181231 56062-939_a9a8b685-d912-44dd-b2bf-e5f7e9df1325 56062-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Publix Super Markets Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 56062-942_fab9f718-68fc-467b-9677-f30559b9f8e9 56062-942 HUMAN OTC DRUG burnrelief Lidocaine HCl GEL TOPICAL 20170110 OTC MONOGRAPH NOT FINAL part348 Publix LIDOCAINE HYDROCHLORIDE 5.05 g/g N 20181231 56062-945_2d01f262-6ffe-4056-93f6-7e15388bb173 56062-945 HUMAN OTC DRUG Body Wash triclosan LIQUID TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part333A Publix Super Markets, Inc. BENZALKONIUM CHLORIDE 1.5 mg/mL N 20181231 56062-947_3ed88f48-454b-4c36-a955-b292cedc2ec7 56062-947 HUMAN OTC DRUG Oil Free Acne Wash Salicylic Acid 2% LOTION TOPICAL 20090512 OTC MONOGRAPH FINAL part333D Publix SALICYLIC ACID 20.6 mg/mL N 20181231 56062-949_97cd5148-6dee-4c14-947a-7adce5687e09 56062-949 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide SUSPENSION ORAL 20050113 OTC MONOGRAPH NOT FINAL part334 Publix Super Markets Inc MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 56062-952_e404d4b0-f4b7-42bf-aa93-985e3bb649ab 56062-952 HUMAN OTC DRUG Epsom Salt MAGNESIUM SULFATE GRANULE ORAL 20130703 OTC MONOGRAPH NOT FINAL part334 Publix Super Markets, Inc., MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 56062-964_90a4da58-2eb6-4723-96dc-d20c914e593c 56062-964 HUMAN OTC DRUG flu and severe cold and cough Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20110929 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 56062-974_6e8b9216-522a-4c7b-b288-ed37f5e7f59e 56062-974 HUMAN OTC DRUG Childrens Allergy cetirizine hydrochloride LIQUID ORAL 20090115 ANDA ANDA090254 Publix Super Markets Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 56062-987_9cbc602c-6636-4d86-b421-a94b5f5346cb 56062-987 HUMAN OTC DRUG Cold and Cough DM Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20140210 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 56062-994_6f5a72d6-5a68-4db7-9457-297492dd4e36 56062-994 HUMAN OTC DRUG daytime pe Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20061102 OTC MONOGRAPH FINAL part341 Publix Super Markets Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 56104-001_31e6fed2-7ed0-4547-ba2f-6fc3e8a23a01 56104-001 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. TOLNAFTATE 1.5 g/150g N 20181231 56104-002_3d68301e-85b2-421f-af24-0be8d51fe748 56104-002 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, POWDER TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. TOLNAFTATE 1.3 g/130g N 20181231 56104-005_6afc2947-ad77-4493-9876-5f5301f728b0 56104-005 HUMAN OTC DRUG Benzocaine and Triclosan First Aid Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Premier Brands of America Inc. BENZOCAINE; TRICLOSAN 17; .11 g/85g; g/85g N 20181231 56104-006_5d925706-e8d9-46fd-e053-2991aa0a2f89 56104-006 HUMAN OTC DRUG Lidocaine Burn Relief Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Premier Brands of America Inc. LIDOCAINE .64 g/127g N 20181231 56104-008_fe33afd9-5d91-4fce-9afb-617a06c59c95 56104-008 HUMAN OTC DRUG Tolnaftate Foot Odor Control Spray Powder AEROSOL, POWDER TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. TOLNAFTATE 1.3 g/113g N 20181231 56104-009_b17c3d52-bd00-4c91-941b-f381cd514ddc 56104-009 HUMAN OTC DRUG Cornex Corn and Callus Liquid Remover LIQUID TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID .17 g/g N 20181231 56104-010_5de3d4b3-2689-94b0-e053-2a91aa0a56f0 56104-010 HUMAN OTC DRUG Salicylic Acid Ultra Thin Corn Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID 40 mg/91 N 20181231 56104-011_2baa6f95-4fc4-4f7d-9f8e-78b12c508312 56104-011 HUMAN OTC DRUG Salicylic Acid Corn Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID 40 mg/91 N 20181231 56104-012_c7662714-8e3a-47fe-80a5-e5e9490f01f9 56104-012 HUMAN OTC DRUG Salicylic Acid Small Corn Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID 40 mg/91 N 20181231 56104-013_00b5b8dc-e4eb-4e66-99a5-72cccb4977ec 56104-013 HUMAN OTC DRUG Salicylic acid Callus Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID 40 mg/41 N 20181231 56104-014_5d7ca544-af8b-6259-e053-2991aa0a8f8a 56104-014 HUMAN OTC DRUG Salicylic acid Extra Thick Callus Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID 40 mg/41 N 20181231 56104-015_4ca3545a-63ce-45c7-82dd-4635a7f442d2 56104-015 HUMAN OTC DRUG Diphenhydramine HCl and Zinc Acetate Extra Strength Itch Relief Continuous Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Premier Brands of America Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.5; .075 g/88mL; g/88mL N 20181231 56104-016_c025c9b2-0677-4fab-b49b-a93d6c261fc0 56104-016 HUMAN OTC DRUG Tolnaftate Antifungal TolnaftateLiquid Continuous Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. TOLNAFTATE 1.5 g/150g N 20181231 56104-017_23fd8621-8a0d-4ba6-b983-27ccc8438fda 56104-017 HUMAN OTC DRUG Salicylic Acid Wart Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID 40 mg/181 N 20181231 56104-018_6180b3e9-ba7c-6ff3-e053-2a91aa0a1fbd 56104-018 HUMAN OTC DRUG Plantar Wart Removers Plantar Wart Removers PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID 40 mg/100mg N 20181231 56104-020_1dd110ac-37aa-46fa-9aac-1460906da7f1 56104-020 HUMAN OTC DRUG Miconazole Nitrate Miconazorb AF Powder POWDER TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. MICONAZOLE NITRATE 1.42 g/71g N 20181231 56104-021_14194dc2-4975-4100-b51b-baf789bc5675 56104-021 HUMAN OTC DRUG Salicylic Acid One-Step Corn Remover Clear PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358F Premier Brands of America Inc. SALICYLIC ACID 40 mg/61 N 20181231 56104-023_d7d0361f-70d5-4fa2-959a-bfd9bbf50f94 56104-023 HUMAN OTC DRUG Wart Remover Liquid Wart Remover Liquid LIQUID TOPICAL 20130101 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID .17 g/g N 20181231 56104-024_9f7ec812-692b-4964-acb1-d366b5bd9ac4 56104-024 HUMAN OTC DRUG Salicylic acid One-Step Wart Remover Tan PLASTER TOPICAL 20130601 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID .4 g/141 N 20181231 56104-025_54b06917-aa8c-4ee0-995c-84bcbfa1f871 56104-025 HUMAN OTC DRUG Wart Remover Liquid Wart Remover Liquid LIQUID TOPICAL 20151028 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID .17 g/9mL N 20181231 56104-026_6323a1ac-d11b-e6ab-e053-2991aa0af5c4 56104-026 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20180119 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID .17 mg/9.8mL N 20191231 56104-031_5d90b095-58bc-3bda-e053-2991aa0aba17 56104-031 HUMAN OTC DRUG Calamine Plus Pramoxine HCl Calamine Plus No Touch Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Premier Brands of America Inc. FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE .345; 24.16; 2.72 mg/177mL; mg/177mL; mg/177mL N 20181231 56104-035_c46c6ba7-684f-443b-b405-441a27f68f1f 56104-035 HUMAN OTC DRUG Witch Hazel Witch Hazel Spray SPRAY TOPICAL 20170301 OTC MONOGRAPH FINAL part347 Premier Brands of America Inc WITCH HAZEL 146 g/170g N 20181231 56104-036_5df43cdd-9279-2868-e053-2991aa0ac410 56104-036 HUMAN OTC DRUG Tolnaftate Tolnaftate Powder Spray Talc Free AEROSOL, SPRAY TOPICAL 20170522 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. TOLNAFTATE 1.3 g/130g N 20181231 56104-037_5da6af5f-d0f7-758f-e053-2991aa0aeae1 56104-037 HUMAN OTC DRUG Tolnaftate Tolnaftate Jock Itch Powder Spray - Talc Free AEROSOL, SPRAY TOPICAL 20171031 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. TOLNAFTATE 1.3 g/130g N 20181231 56104-038_5da7b16f-324c-34eb-e053-2991aa0a7046 56104-038 HUMAN OTC DRUG Miconazole Nitrate Jock Itch Spray Talc Free AEROSOL, SPRAY TOPICAL 20170610 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc MICONAZOLE NITRATE 1.3 g/130g N 20181231 56104-039_5df6fef0-4e3e-9cb8-e053-2a91aa0a21e5 56104-039 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Powder Miconazole Nitrate Talc Free POWDER TOPICAL 20170403 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. MICONAZOLE NITRATE 1.42 g/71g N 20181231 56104-040_95b312ba-debc-4130-a261-f46a247803f5 56104-040 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20180103 OTC MONOGRAPH NOT FINAL part333A Premier Brands of America Inc BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/9mL; mg/9mL N 20191231 56104-114_6d7e6fb0-2290-4750-a477-a6d25a301bee 56104-114 HUMAN OTC DRUG Undecylenic Acid Liquid Anti-Fungal Liquid LIQUID TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. UNDECYLENIC ACID .25 g/g N 20181231 56104-116_081bbbf7-66d9-4de6-a357-844efd6e047e 56104-116 HUMAN OTC DRUG Undecylenic Acid Anti-Fungal Pen LIQUID TOPICAL 20130701 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. UNDECYLENIC ACID 40 mg/1.7mL N 20181231 56104-136_1ef08164-1495-4606-87e7-43cc6fb675e7 56104-136 HUMAN OTC DRUG Menthol Maximum Strength Medicated Foot Powder POWDER TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Premier Brands of America Inc. MENTHOL 2.83 g/283g N 20181231 56104-141_5d7ad3dc-c7d5-aa79-e053-2a91aa0aacdf 56104-141 HUMAN OTC DRUG Miconazole nitrate Antifungal Miconazole Liquid Continuous Spray AEROSOL, SPRAY TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. MICONAZOLE NITRATE 3 g/150g N 20181231 56104-237_5e0851eb-2868-5665-e053-2a91aa0a6d2f 56104-237 HUMAN OTC DRUG Wart Remover Gel Wart Remover Gel GEL TOPICAL 20130101 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID .17 g/g N 20181231 56104-243_56afeb55-d6aa-438c-ae7e-333f97b5d7c0 56104-243 HUMAN OTC DRUG One-Step Wart Remover Clear One-Step Wart Remover PATCH TOPICAL 20130101 OTC MONOGRAPH FINAL part358B Premier Brands of America Inc. SALICYLIC ACID .4 g/g N 20181231 56104-301_5e06b9bb-5ced-784f-e053-2991aa0ac41b 56104-301 HUMAN OTC DRUG Miconazole Nitrate Antifungal Miconazole Powder Jock Itch Spray AEROSOL, POWDER TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. MICONAZOLE NITRATE 2.6 g/130g N 20181231 56104-302_7d351f28-98c5-4ef3-aea3-f7edaac435e7 56104-302 HUMAN OTC DRUG Miconazole nitrate Antifungal Miconazole Powder Spray AEROSOL, POWDER TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. MICONAZOLE NITRATE 2.6 g/130g N 20181231 56104-527_dfbd695e-1c3b-4569-9191-ce19b92ca52f 56104-527 HUMAN OTC DRUG Tolnaftate Medicated Jock Itch Powder Spray AEROSOL, POWDER TOPICAL 20130101 OTC MONOGRAPH FINAL part333C Premier Brands of America Inc. TOLNAFTATE 1.3 g/130g N 20181231 56130-001_5233ff7f-e94f-4cb4-9ed9-e245456f01c9 56130-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130101 NDA NDA205865 All Gas & Welding Supplies Co., Inc. OXYGEN 990 L/L N 20181231 56131-759_03289a1e-75b4-4eb8-97b4-951927684265 56131-759 HUMAN OTC DRUG Luxury Antibacterial Foaming Tricolsan SOAP TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part333E RD Food Service DBA Restaurant Depot TRICLOSAN 6 mg/mL E 20171231 56131-774_c9cf1456-0abf-4109-bb13-a7827e4df638 56131-774 HUMAN OTC DRUG Instant Foaming Hand Sanitizer Alcohol SOAP TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part333E RD Food Service DBA Restaurant Depot ALCOHOL .7 mL/mL E 20171231 56136-001_69db839e-cb3a-43fd-8bea-5a1785ff900e 56136-001 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL E 20171231 56136-002_2b117ea1-6a35-4e1a-b401-c239c57e0942 56136-002 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL E 20171231 56136-003_8d145e4e-ffb6-43f1-bdf0-56389b53fede 56136-003 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL E 20171231 56136-004_47f461ac-f1b4-4045-96ef-aedbe2ee757d 56136-004 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL E 20171231 56136-005_2aa0fc56-e850-442c-86df-757bb760360d 56136-005 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL E 20171231 56136-006_8e26535d-a86a-40e6-ae87-d2e0d5bf60b7 56136-006 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL E 20171231 56136-007_614acfdd-e69a-462f-b615-06504714143f 56136-007 HUMAN OTC DRUG Spatheraphy ALCOHOL LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. ALCOHOL 18.6 mL/30mL E 20171231 56136-008_25f45327-6e16-496e-910f-38eaff5b5c8e 56136-008 HUMAN OTC DRUG Spatherapy BENZALKONIUM CHLORIDE LOTION TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. BENZALKONIUM CHLORIDE .56 g/293g E 20171231 56136-009_2358507e-43b5-41e5-9d20-80f602859390 56136-009 HUMAN OTC DRUG Spatherapy BENZALKONIUM CHLORIDE LOTION TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. BENZALKONIUM CHLORIDE .56 g/293g E 20171231 56136-010_4251f6ff-0f25-4ec6-9093-be854c680382 56136-010 HUMAN OTC DRUG Spatherapy TRICLOSAN LOTION TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. TRICLOSAN .79 g/293g E 20171231 56136-011_46dc299e-ccb4-4ee0-bb76-da3626ca3067 56136-011 HUMAN OTC DRUG Spatherapy BENZALKONIUM CHLORIDE LOTION TOPICAL 20140327 OTC MONOGRAPH NOT FINAL part333E Xiamen Olivee Daily Use Chemical Co., Ltd. BENZALKONIUM CHLORIDE .56 g/293g E 20171231 56149-001_d5be2f7d-26e8-4cb9-b551-f52368a8cb5f 56149-001 HUMAN OTC DRUG Serdaen Chlorhexidine Diacetate SOAP TOPICAL 20130601 UNAPPROVED DRUG OTHER Browne Hansen LLC CHLORHEXIDINE ACETATE 24 mg/3g E 20171231 56149-002_cb80b579-2303-4261-8eba-426e54b7ffc7 56149-002 HUMAN OTC DRUG Serdaen Chlorhexidine Diacetate SOAP TOPICAL 20130601 UNAPPROVED DRUG OTHER Browne Hansen LLC CHLORHEXIDINE ACETATE 48 mg/3g E 20171231 56151-680_5cc564c1-32e6-9b0e-e053-2a91aa0a218b 56151-680 HUMAN OTC DRUG TRUEplus diabetics daily hydrating TRUEplus diabetics daily hydrating lotion LOTION TOPICAL 20160129 OTC MONOGRAPH FINAL part347 Trividia Health, Inc. DIMETHICONE 2 g/100g N 20181231 56151-681_5da49bf5-f4a9-4d5a-e053-2a91aa0abb5a 56151-681 HUMAN OTC DRUG Diabetics intensive moisturizing Diabetics intensive moisturizing CREAM TOPICAL 20150227 OTC MONOGRAPH FINAL part347 Trividia Health, Inc. DIMETHICONE 5 g/100g N 20181231 56151-682_5f4c4afd-43cd-f2b2-e053-2991aa0ab8f0 56151-682 HUMAN OTC DRUG TRUEplus diabetics foot care TRUEplus diabetics foot care CREAM TOPICAL 20150227 OTC MONOGRAPH FINAL part347 Trividia Health, Inc. DIMETHICONE 5 g/100g N 20181231 56151-683_5f0effd4-5ae1-d7a6-e053-2a91aa0ac4c9 56151-683 HUMAN OTC DRUG Essentials Trial Kit Essentials Trial Kit KIT 20160318 OTC MONOGRAPH FINAL part347 Trividia Health, Inc. N 20181231 56152-0010_7308121e-8388-4511-999f-72d7b3d4e59a 56152-0010 HUMAN OTC DRUG Rodan and Fields Unblemish - Acne Medicated Benzoyl Peroxide CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333 Cosmetic Enterprises BENZOYL PEROXIDE 2.5 mL/100mL N 20181231 56152-0815_272dbb65-38be-43ca-8b07-19e0786e89f4 56152-0815 HUMAN OTC DRUG Rodan and Fields Essentials UVA/UVB Avobenzone, Octinoxate, Oxybenzone CREAM TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Cosmetic Enterprises Ltd. AVOBENZONE; OCTINOXATE; OXYBENZONE 2; 7.5; 3 mL/100mL; mL/100mL; mL/100mL N 20181231 56152-2003_357d8586-c3a0-419d-ab98-5ba60caf5536 56152-2003 HUMAN OTC DRUG Rodan and Fields Soothe Hydrocortisone CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333 Cosmetic Enterprises Ltd. HYDROCORTISONE 1 mg/100mL N 20181231 56152-2050_4eb3a032-e4fd-41e6-9e1d-ffea75bab477 56152-2050 HUMAN OTC DRUG Rodan and Fields Unblemish 1 Wash Acne Medicated Cleanser Sulfur CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333 Cosmetic Enterprises Ltd. SULFUR 3 mL/100mL N 20181231 56152-4008_d9c1176b-270f-43cb-8ea5-3506e984cd07 56152-4008 HUMAN OTC DRUG SPF 50 Face Sunscreen Bioelements Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20160104 OTC MONOGRAPH FINAL part352 Cosmetic Enterprises Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7; 5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 56152-4009_aa398e18-1f56-421f-a61b-90bc9814a1d0 56152-4009 HUMAN OTC DRUG Breakout Control Bioelements Benzoyl Peroxide CREAM TOPICAL 20130614 OTC MONOGRAPH FINAL part333D Cosmetic Enterprises Ltd BENZOYL PEROXIDE 5 g/100mL N 20181231 56152-5000_ac0deac9-6120-49af-979d-765859e0111d 56152-5000 HUMAN OTC DRUG Clear Acne Body Paulas Choice Salicylic Acid SPRAY TOPICAL 20160809 OTC MONOGRAPH FINAL part333D Cosmetic Enterprises Ltd SALICYLIC ACID 2 g/118mL N 20181231 56152-5001_d20f315a-c045-4526-ba17-281b81ab3a8e 56152-5001 HUMAN OTC DRUG Skin Balancing Ultra Sheer Daily Defence SPF 30 Paulas Choice Avobenzone, Homosalate, Octocrylene, Oxybenzone CREAM TOPICAL 20160812 OTC MONOGRAPH FINAL part352 Cosmetic Enterprises Ltd AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 7; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 56152-5002_16b234d8-87fc-4854-ba14-437d03689958 56152-5002 HUMAN OTC DRUG Clear Exfoliating Solution Paulas Choice Salicylic Acid CREAM TOPICAL 20160809 OTC MONOGRAPH FINAL part333D Cosmetic Enterprises Ltd SALICYLIC ACID 2 g/100mL N 20181231 56152-5003_c07385a0-6b4f-4752-883b-1ebe84895a4c 56152-5003 HUMAN OTC DRUG Resist Wrinkle Defense SPF 30 Paulas Choice Zinc Oxide CREAM TOPICAL 20160810 OTC MONOGRAPH FINAL part352 Cosmetic Enterprises Ltd ZINC OXIDE 13 g/100mL N 20181231 56152-5004_907145a2-53bf-4dd3-80ad-9fdf0713c1b6 56152-5004 HUMAN OTC DRUG Active Radiance Day Moisture SPF 30 Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20170301 OTC MONOGRAPH FINAL part352 COSMETIC ENTERPRISES LTD AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 5; 2.4; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 56152-5005_7300a483-0006-42e8-962c-949c991ac8f3 56152-5005 HUMAN OTC DRUG Accelerated Dark Spot Corrector Hydroquinone CREAM TOPICAL 20170612 OTC MONOGRAPH NOT FINAL part358A COSMETIC ENTERPRISES LTD HYDROQUINONE 2 g/100mL N 20181231 56152-5010_213ae860-c30f-4e68-972f-3c606e831469 56152-5010 HUMAN OTC DRUG NexGen Sunscreen Broad Spectrum SPF 36 Doc Martins Octinoxate, Oxybenzone, Octocrylene, Avobenzone CREAM TOPICAL 20170321 OTC MONOGRAPH FINAL part352 Cosmetic Enterprises Ltd. OCTINOXATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 7; 5; 4; 3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 56153-001_5cd79fe8-e694-6009-e053-2a91aa0a89d6 56153-001 HUMAN OTC DRUG Colgate Anticavity Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 Ming Fai Industrial (Shenzhen) Co. Ltd SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 56153-002_5d7aee26-0e5c-4fc3-e053-2991aa0a6192 56153-002 HUMAN OTC DRUG Colgate Anticavity Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 Ming Fai Industrial (Shenzhen) Co. Ltd SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 57236-0001_fea32d30-0d9b-48ac-be18-989f3fb18d34 57236-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Saginaw Weldilng Supply Company OXYGEN 99 L/100L E 20171231 57237-001_713696b7-a15d-4bfd-8206-8490b4917891 57237-001 HUMAN PRESCRIPTION DRUG Lansoprazole, Amoxicillin, Clarithromycin Lansoprazole, Amoxicillin, Clarithromycin KIT 20161014 ANDA ANDA206006 Citron Pharma LLC N 20181231 57237-002_22c46c52-dcb8-4fb9-9ecf-d92c60bbfe2c 57237-002 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20070919 ANDA ANDA078164 Citron Pharma LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57237-003_58b5729b-3ec8-4486-a1f2-870ed7a354f4 57237-003 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Citron Pharma LLC FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 57237-004_58b5729b-3ec8-4486-a1f2-870ed7a354f4 57237-004 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Citron Pharma LLC FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 57237-005_58b5729b-3ec8-4486-a1f2-870ed7a354f4 57237-005 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Citron Pharma LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 57237-006_58b5729b-3ec8-4486-a1f2-870ed7a354f4 57237-006 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Citron Pharma LLC FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 57237-007_bc2c71e1-663d-473a-b74b-481bd36e3631 57237-007 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Citron Pharma LLC MIRTAZAPINE 7.5 mg/1 N 20181231 57237-008_bc2c71e1-663d-473a-b74b-481bd36e3631 57237-008 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Citron Pharma LLC MIRTAZAPINE 15 mg/1 N 20181231 57237-009_bc2c71e1-663d-473a-b74b-481bd36e3631 57237-009 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Citron Pharma LLC MIRTAZAPINE 30 mg/1 N 20181231 57237-010_bc2c71e1-663d-473a-b74b-481bd36e3631 57237-010 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Citron Pharma LLC MIRTAZAPINE 45 mg/1 N 20181231 57237-011_457750f3-de56-42ff-b2f4-4c19853d5d1f 57237-011 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Citron Pharma LLC MIRTAZAPINE 15 mg/1 N 20181231 57237-012_457750f3-de56-42ff-b2f4-4c19853d5d1f 57237-012 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Citron Pharma LLC MIRTAZAPINE 30 mg/1 N 20181231 57237-013_457750f3-de56-42ff-b2f4-4c19853d5d1f 57237-013 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20060228 ANDA ANDA077376 Citron Pharma LLC MIRTAZAPINE 45 mg/1 N 20181231 57237-014_db6a9381-7980-43e3-9452-919d3d59bf3a 57237-014 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 Citron Pharma LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 57237-017_d39b70c6-e533-4b11-bec5-1ec751ea8ee0 57237-017 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Citron Pharma LLC DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-018_d39b70c6-e533-4b11-bec5-1ec751ea8ee0 57237-018 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Citron Pharma LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-019_d39b70c6-e533-4b11-bec5-1ec751ea8ee0 57237-019 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Citron Pharma LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-020_d40c7917-a65d-4bc3-b71d-15d96d08e296 57237-020 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20071018 ANDA ANDA077537 Citron Pharma LLC GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 57237-021_d40c7917-a65d-4bc3-b71d-15d96d08e296 57237-021 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20071018 ANDA ANDA077537 Citron Pharma LLC GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 57237-022_d40c7917-a65d-4bc3-b71d-15d96d08e296 57237-022 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20071018 ANDA ANDA077537 Citron Pharma LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 57237-023_c5ab59b5-f983-4974-af6c-f02862371d81 57237-023 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Citron Pharma LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 57237-024_c5ab59b5-f983-4974-af6c-f02862371d81 57237-024 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Citron Pharma LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 57237-025_c5ab59b5-f983-4974-af6c-f02862371d81 57237-025 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Citron Pharma LLC GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 57237-026_978a5492-0c73-42ca-a15b-bba3eb70b41e 57237-026 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA079245 Citron Pharma LLC FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57237-027_978a5492-0c73-42ca-a15b-bba3eb70b41e 57237-027 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA079245 Citron Pharma LLC FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57237-028_a8933dc0-ea70-4f22-977c-0e89d6f680ad 57237-028 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Citron Pharma LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 57237-029_a8933dc0-ea70-4f22-977c-0e89d6f680ad 57237-029 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Citron Pharma LLC AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 57237-030_a065888d-3220-4e24-afae-19b29780a7af 57237-030 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Rising Health, LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 57237-031_a065888d-3220-4e24-afae-19b29780a7af 57237-031 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Rising Health, LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 57237-032_a675501f-fad6-4fbb-9d93-e093907c141d 57237-032 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Citron Pharma LLC AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 57237-033_a675501f-fad6-4fbb-9d93-e093907c141d 57237-033 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Citron Pharma LLC AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 57237-034_d7fac9cc-30e1-4762-a01b-04f1bd3b2a56 57237-034 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070130 ANDA ANDA065381 Citron Pharma LLC CEFPROZIL 125 mg/5mL N 20181231 57237-035_d7fac9cc-30e1-4762-a01b-04f1bd3b2a56 57237-035 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070130 ANDA ANDA065381 Citron Pharma LLC CEFPROZIL 250 mg/5mL N 20181231 57237-036_af24a86f-8072-49a6-94ec-2f17fe81812b 57237-036 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 Citron Pharma LLC CEFPROZIL 250 mg/1 N 20181231 57237-037_af24a86f-8072-49a6-94ec-2f17fe81812b 57237-037 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 Citron Pharma LLC CEFPROZIL 500 mg/1 N 20181231 57237-040_99345baa-ede5-472e-adaf-861d7fb27921 57237-040 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Citron Pharma LLC PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 57237-041_99345baa-ede5-472e-adaf-861d7fb27921 57237-041 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Citron Pharma LLC PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 57237-042_8d1645c0-fd03-4992-9372-98026a26b3af 57237-042 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Citron Pharma LLC VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 57237-043_8d1645c0-fd03-4992-9372-98026a26b3af 57237-043 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Citron Pharma LLC VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 57237-044_d9b3396b-da77-46e9-8c73-e1d6b2eb1447 57237-044 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20120725 ANDA ANDA065489 Citron Pharma LLC CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 57237-045_d9b3396b-da77-46e9-8c73-e1d6b2eb1447 57237-045 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20120725 ANDA ANDA065489 Citron Pharma LLC CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 57237-047_72a3e329-86dd-4bb1-98bc-a5563213de0c 57237-047 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110421 ANDA ANDA090554 Citron Pharma LLC DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 57237-048_72a3e329-86dd-4bb1-98bc-a5563213de0c 57237-048 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110421 ANDA ANDA090554 Citron Pharma LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 57237-049_49f2e942-faab-4ef5-a37c-2947303c89f1 57237-049 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 Citron Pharma LLC GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 57237-050_49f2e942-faab-4ef5-a37c-2947303c89f1 57237-050 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 Citron Pharma LLC GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 57237-051_49f2e942-faab-4ef5-a37c-2947303c89f1 57237-051 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 Citron Pharma LLC GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 57237-052_dc0a5a29-63b0-44f6-ad5b-e39e7634b5b4 57237-052 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Citron Pharma LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-053_dc0a5a29-63b0-44f6-ad5b-e39e7634b5b4 57237-053 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Citron Pharma LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-054_dc0a5a29-63b0-44f6-ad5b-e39e7634b5b4 57237-054 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Citron Pharma LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-055_dc0a5a29-63b0-44f6-ad5b-e39e7634b5b4 57237-055 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Citron Pharma LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-056_dc0a5a29-63b0-44f6-ad5b-e39e7634b5b4 57237-056 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Citron Pharma LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-057_dc0a5a29-63b0-44f6-ad5b-e39e7634b5b4 57237-057 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Citron Pharma LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-058_cf3118f7-c15a-4265-a1d7-6c87ac540315 57237-058 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20060329 ANDA ANDA065308 Citron Pharma LLC CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 57237-059_cf3118f7-c15a-4265-a1d7-6c87ac540315 57237-059 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20060329 ANDA ANDA065308 Citron Pharma LLC CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 57237-061_c4bc53b6-ff3e-4fe8-90d1-3f5ea2ce8526 57237-061 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20131105 ANDA ANDA203687 Citron Pharma LLC FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 57237-062_6502a2d1-6c0e-4d98-9a3e-83e5bab2b5fe 57237-062 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20071030 ANDA ANDA078341 Citron Pharma LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 57237-063_e56335c1-5508-4136-bd2e-18385623e497 57237-063 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20150708 ANDA ANDA202821 Citron Pharma LLC FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] N 20181231 57237-064_e56335c1-5508-4136-bd2e-18385623e497 57237-064 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20150708 ANDA ANDA202821 Citron Pharma LLC FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 57237-065_e56335c1-5508-4136-bd2e-18385623e497 57237-065 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20150708 ANDA ANDA202821 Citron Pharma LLC FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 57237-066_7138748e-64e4-4650-a555-cbc5280e2109 57237-066 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Citron Pharma LLC LEVOFLOXACIN 250 mg/1 N 20181231 57237-067_7138748e-64e4-4650-a555-cbc5280e2109 57237-067 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Citron Pharma LLC LEVOFLOXACIN 500 mg/1 N 20181231 57237-068_7138748e-64e4-4650-a555-cbc5280e2109 57237-068 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Citron Pharma LLC LEVOFLOXACIN 750 mg/1 N 20181231 57237-075_42578a3d-d419-4cf3-827c-7924ffed15e1 57237-075 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Citron Pharma LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 57237-076_42578a3d-d419-4cf3-827c-7924ffed15e1 57237-076 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Citron Pharma LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 57237-077_9f12a7a6-14d7-4ac9-b364-d3ba7bd3633c 57237-077 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Citron Pharma LLC ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 57237-078_9f12a7a6-14d7-4ac9-b364-d3ba7bd3633c 57237-078 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Citron Pharma LLC ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 57237-079_79f30d56-227e-4b02-9558-382cb3a6cb6f 57237-079 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Citron Pharma LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 57237-080_79f30d56-227e-4b02-9558-382cb3a6cb6f 57237-080 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Citron Pharma LLC QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 57237-081_79f30d56-227e-4b02-9558-382cb3a6cb6f 57237-081 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Citron Pharma LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 57237-082_79f30d56-227e-4b02-9558-382cb3a6cb6f 57237-082 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Citron Pharma LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 57237-083_79f30d56-227e-4b02-9558-382cb3a6cb6f 57237-083 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Citron Pharma LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 57237-084_79f30d56-227e-4b02-9558-382cb3a6cb6f 57237-084 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Citron Pharma LLC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 57237-085_481e8150-90b5-495f-80e6-03ce648b1d65 57237-085 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203062 Citron Pharma LLC RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 57237-086_481e8150-90b5-495f-80e6-03ce648b1d65 57237-086 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203062 Citron Pharma LLC RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 57237-087_ae97262b-86f5-4e45-8797-8f5f733c6296 57237-087 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA202490 Citron Pharma LLC RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 57237-088_ae97262b-86f5-4e45-8797-8f5f733c6296 57237-088 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA202490 Citron Pharma LLC RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 57237-089_9667267c-79bf-420f-a0a9-ac1d4677180d 57237-089 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA078438 Citron Pharma LLC TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-090_9667267c-79bf-420f-a0a9-ac1d4677180d 57237-090 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA078438 Citron Pharma LLC TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-091_9667267c-79bf-420f-a0a9-ac1d4677180d 57237-091 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA078438 Citron Pharma LLC TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-092_12f6a619-58cb-4428-bfa5-66859253efed 57237-092 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 Citron Pharma LLC ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-093_12f6a619-58cb-4428-bfa5-66859253efed 57237-093 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 Citron Pharma LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-094_12f6a619-58cb-4428-bfa5-66859253efed 57237-094 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 Citron Pharma LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-095_6447b7b9-01aa-4954-b7e1-7adfcbc19c71 57237-095 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate SOLUTION ORAL 20120403 ANDA ANDA079062 Citron Pharma LLC ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-096_74c99fd8-16d1-4d2c-9158-42ff5eed2b7c 57237-096 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070125 ANDA ANDA065352 Citron Pharma LLC CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 57237-097_6e4111d3-f11b-403c-b340-b216022709df 57237-097 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20130425 ANDA ANDA065349 Citron Pharma LLC CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 57237-098_6e4111d3-f11b-403c-b340-b216022709df 57237-098 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20130425 ANDA ANDA065349 Citron Pharma LLC CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 57237-099_c2dab372-9abb-4795-8d78-73f15f0d63ac 57237-099 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107 ANDA ANDA065434 Citron Pharma LLC CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 57237-100_41cb21df-c514-4736-88dd-094f398de8d0 57237-100 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Citron Pharma LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57237-101_41cb21df-c514-4736-88dd-094f398de8d0 57237-101 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Citron Pharma LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57237-102_41cb21df-c514-4736-88dd-094f398de8d0 57237-102 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Citron Pharma LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57237-103_f317afcd-de7c-444f-964c-2bcff67c3f24 57237-103 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Citron Pharma LLC DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 57237-104_f317afcd-de7c-444f-964c-2bcff67c3f24 57237-104 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Citron Pharma LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 57237-105_5c196d06-43b9-46d4-8272-403e73ab646e 57237-105 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 Citron Pharma LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 57237-106_72a3e329-86dd-4bb1-98bc-a5563213de0c 57237-106 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141024 ANDA ANDA090554 Citron Pharma LLC DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 57237-108_f5f56c59-04d5-4c5d-9441-5a93d3bdec82 57237-108 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130117 ANDA ANDA203417 Citron Pharma LLC FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 57237-109_f5f56c59-04d5-4c5d-9441-5a93d3bdec82 57237-109 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130117 ANDA ANDA203417 Citron Pharma LLC FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 57237-110_f5f56c59-04d5-4c5d-9441-5a93d3bdec82 57237-110 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130117 ANDA ANDA203417 Citron Pharma LLC FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 57237-114_4fb898d6-dbb0-43c0-8369-b67719afba6b 57237-114 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120830 ANDA ANDA079060 Citron Pharma LLC ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 57237-119_15b304f4-d211-4c55-bcd7-3f9fd9c49421 57237-119 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Citron Pharma LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 57237-120_15b304f4-d211-4c55-bcd7-3f9fd9c49421 57237-120 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Citron Pharma LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 57237-121_15b304f4-d211-4c55-bcd7-3f9fd9c49421 57237-121 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Citron Pharma LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 57237-122_15b304f4-d211-4c55-bcd7-3f9fd9c49421 57237-122 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Citron Pharma LLC WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 57237-123_15b304f4-d211-4c55-bcd7-3f9fd9c49421 57237-123 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Citron Pharma LLC WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 57237-124_15b304f4-d211-4c55-bcd7-3f9fd9c49421 57237-124 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Citron Pharma LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 57237-125_15b304f4-d211-4c55-bcd7-3f9fd9c49421 57237-125 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Citron Pharma LLC WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 57237-126_15b304f4-d211-4c55-bcd7-3f9fd9c49421 57237-126 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Citron Pharma LLC WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 57237-127_15b304f4-d211-4c55-bcd7-3f9fd9c49421 57237-127 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20111101 ANDA ANDA090935 Citron Pharma LLC WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 57237-129_b9658136-c2b1-492e-a9ff-8a8d4e5f5ff6 57237-129 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B sulfates, Bacitracin zinc Neomycin and Polymyxin B sulfates, Bacitracin zinc OINTMENT OPHTHALMIC 20170410 NDA NDA050417 Citron Pharma LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 57237-132_c818c38d-ee37-4ceb-b078-611483b4f743 57237-132 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20061227 ANDA ANDA077910 Citron Pharma LLC BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57237-133_c818c38d-ee37-4ceb-b078-611483b4f743 57237-133 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20061227 ANDA ANDA077910 Citron Pharma LLC BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57237-134_550b5383-3f5e-49c8-a3a4-cb29502bb8d5 57237-134 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078462 Citron Pharma LLC TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 57237-135_550b5383-3f5e-49c8-a3a4-cb29502bb8d5 57237-135 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078462 Citron Pharma LLC TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 57237-136_550b5383-3f5e-49c8-a3a4-cb29502bb8d5 57237-136 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078462 Citron Pharma LLC TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 57237-137_550b5383-3f5e-49c8-a3a4-cb29502bb8d5 57237-137 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078462 Citron Pharma LLC TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 57237-138_3c8f1c0b-8a44-4ca0-b2cf-3c591f8878fd 57237-138 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Citron Pharma LLC TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 57237-139_3c8f1c0b-8a44-4ca0-b2cf-3c591f8878fd 57237-139 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Citron Pharma LLC TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 57237-140_3c8f1c0b-8a44-4ca0-b2cf-3c591f8878fd 57237-140 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Citron Pharma LLC TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 57237-141_3c8f1c0b-8a44-4ca0-b2cf-3c591f8878fd 57237-141 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Citron Pharma LLC TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 57237-142_03b175fc-d430-490d-b7ac-9f7a2cb1dd8b 57237-142 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Citron Pharma LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 57237-143_03b175fc-d430-490d-b7ac-9f7a2cb1dd8b 57237-143 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Citron Pharma LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 57237-144_03b175fc-d430-490d-b7ac-9f7a2cb1dd8b 57237-144 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Citron Pharma LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 57237-145_03b175fc-d430-490d-b7ac-9f7a2cb1dd8b 57237-145 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Citron Pharma LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 57237-146_03b175fc-d430-490d-b7ac-9f7a2cb1dd8b 57237-146 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Citron Pharma LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 57237-147_03b175fc-d430-490d-b7ac-9f7a2cb1dd8b 57237-147 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Citron Pharma LLC AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 57237-148_95befa8b-c738-4a2f-965a-cf1901b477e8 57237-148 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide SOLUTION ORAL 20060828 ANDA ANDA077812 Citron Pharma LLC CITALOPRAM HYDROBROMIDE 10 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-149_ccbe0991-27a1-4ddb-bfc7-1b3422e53390 57237-149 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20090918 ANDA ANDA079150 Citron Pharma LLC FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 57237-150_ccbe0991-27a1-4ddb-bfc7-1b3422e53390 57237-150 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20090918 ANDA ANDA079150 Citron Pharma LLC FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 57237-151_15f4e6d9-4937-45fe-826a-94753b7be19a 57237-151 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120629 ANDA ANDA202759 Citron Pharma LLC GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 57237-152_15f4e6d9-4937-45fe-826a-94753b7be19a 57237-152 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120629 ANDA ANDA202759 Citron Pharma LLC GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 57237-153_15f4e6d9-4937-45fe-826a-94753b7be19a 57237-153 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120629 ANDA ANDA202759 Citron Pharma LLC GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 57237-154_4b63aac6-4385-44a3-8390-cdbb0b4b5fe0 57237-154 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120927 ANDA ANDA202566 Citron Pharma LLC MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 57237-155_4b63aac6-4385-44a3-8390-cdbb0b4b5fe0 57237-155 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120927 ANDA ANDA202566 Citron Pharma LLC MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 57237-156_f34c08e6-fe74-4de3-9e36-a82c3c1c183b 57237-156 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET, FILM COATED ORAL 20140304 ANDA ANDA202632 Citron Pharma LLC MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 57237-157_d7673e22-0dbb-4395-ad60-943d249203a1 57237-157 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA203820 Citron Pharma LLC REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 57237-158_d7673e22-0dbb-4395-ad60-943d249203a1 57237-158 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA203820 Citron Pharma LLC REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 57237-159_d7673e22-0dbb-4395-ad60-943d249203a1 57237-159 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA203820 Citron Pharma LLC REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 57237-160_a1b1c61b-d4fe-433d-ad31-0b11758976fa 57237-160 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150819 ANDA ANDA203270 Citron Pharma LLC OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 57237-161_a1b1c61b-d4fe-433d-ad31-0b11758976fa 57237-161 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150819 ANDA ANDA203270 Citron Pharma LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 57237-162_a1b1c61b-d4fe-433d-ad31-0b11758976fa 57237-162 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150819 ANDA ANDA203270 Citron Pharma LLC OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 57237-163_43a308a0-1d18-46c2-aae6-5b80ce448660 57237-163 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20150916 ANDA ANDA202726 Citron Pharma LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 57237-164_12fe91b6-d141-43a1-acdf-1dc607982acb 57237-164 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20170202 ANDA ANDA203367 Citron Pharma LLC PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 57237-165_12fe91b6-d141-43a1-acdf-1dc607982acb 57237-165 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20170202 ANDA ANDA203367 Citron Pharma LLC PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 57237-166_12fe91b6-d141-43a1-acdf-1dc607982acb 57237-166 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20170202 ANDA ANDA203367 Citron Pharma LLC PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 57237-167_12fe91b6-d141-43a1-acdf-1dc607982acb 57237-167 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20170202 ANDA ANDA203367 Citron Pharma LLC PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 57237-168_458d8a48-4499-42f3-bbf6-ad2659f880f0 57237-168 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Rising Health, LLC ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 57237-169_458d8a48-4499-42f3-bbf6-ad2659f880f0 57237-169 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Rising Health, LLC ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 57237-170_458d8a48-4499-42f3-bbf6-ad2659f880f0 57237-170 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Rising Health, LLC ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 57237-171_458d8a48-4499-42f3-bbf6-ad2659f880f0 57237-171 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Rising Health, LLC ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 57237-172_67361224-94cf-4c62-8035-e737d933470c 57237-172 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Citron Pharma LLC VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-173_67361224-94cf-4c62-8035-e737d933470c 57237-173 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Citron Pharma LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-174_67361224-94cf-4c62-8035-e737d933470c 57237-174 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Citron Pharma LLC VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-175_67361224-94cf-4c62-8035-e737d933470c 57237-175 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Citron Pharma LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-176_67361224-94cf-4c62-8035-e737d933470c 57237-176 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Citron Pharma LLC VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57237-180_d8adefa7-6b67-40a2-9ce2-d46c422c12ab 57237-180 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Citron Pharma LLC PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 57237-181_d8adefa7-6b67-40a2-9ce2-d46c422c12ab 57237-181 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Citron Pharma LLC PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 57237-182_d8adefa7-6b67-40a2-9ce2-d46c422c12ab 57237-182 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Citron Pharma LLC PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 57237-183_d8adefa7-6b67-40a2-9ce2-d46c422c12ab 57237-183 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Citron Pharma LLC PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 57237-184_d8adefa7-6b67-40a2-9ce2-d46c422c12ab 57237-184 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Citron Pharma LLC PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 57237-185_d8adefa7-6b67-40a2-9ce2-d46c422c12ab 57237-185 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Citron Pharma LLC PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 57237-189_954a65d1-79ed-4705-be2d-4d7e6f13f538 57237-189 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 Citron Pharma LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 57237-190_52408032-5f3e-4157-a271-e910ac514102 57237-190 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20080926 ANDA ANDA078643 Citron Pharma LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 57237-191_52408032-5f3e-4157-a271-e910ac514102 57237-191 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20080926 ANDA ANDA078643 Citron Pharma LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 57237-192_5fc06788-5c30-40fc-bab0-382173f99ed4 57237-192 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090056 Citron Pharma LLC DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 57237-193_5fc06788-5c30-40fc-bab0-382173f99ed4 57237-193 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090056 Citron Pharma LLC DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 57237-194_7a58bb13-3fa9-457e-ad16-2de9aab7b862 57237-194 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 Citron Pharma LLC FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 57237-195_7a58bb13-3fa9-457e-ad16-2de9aab7b862 57237-195 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 Citron Pharma LLC FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 57237-196_7a58bb13-3fa9-457e-ad16-2de9aab7b862 57237-196 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 Citron Pharma LLC FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 57237-198_6d3c9548-985d-4b01-9d3b-360f5abbdd79 57237-198 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070720 ANDA ANDA040780 Citron Pharma LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57237-199_6d3c9548-985d-4b01-9d3b-360f5abbdd79 57237-199 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070720 ANDA ANDA040780 Citron Pharma LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57237-200_eca52b04-b3d8-4c7f-ba80-148dde973333 57237-200 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Citron Pharma LLC LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 57237-201_eca52b04-b3d8-4c7f-ba80-148dde973333 57237-201 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Citron Pharma LLC LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 57237-202_eca52b04-b3d8-4c7f-ba80-148dde973333 57237-202 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Citron Pharma LLC LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 57237-203_eca52b04-b3d8-4c7f-ba80-148dde973333 57237-203 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Citron Pharma LLC LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 57237-204_9cb7a81e-06ba-4376-99b4-ccaa9d61a459 57237-204 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA090083 Citron Pharma LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 57237-205_9cb7a81e-06ba-4376-99b4-ccaa9d61a459 57237-205 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA090083 Citron Pharma LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 57237-206_9cb7a81e-06ba-4376-99b4-ccaa9d61a459 57237-206 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA090083 Citron Pharma LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 57237-207_c4ae74cf-d27d-4429-9291-d25820e222fb 57237-207 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Citron Pharma LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57237-208_c4ae74cf-d27d-4429-9291-d25820e222fb 57237-208 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Citron Pharma LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57237-209_c4ae74cf-d27d-4429-9291-d25820e222fb 57237-209 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Citron Pharma LLC LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57237-210_12195e1c-b456-43a8-b5b2-48683d39da82 57237-210 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120720 ANDA ANDA079118 Citron Pharma LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 57237-211_12195e1c-b456-43a8-b5b2-48683d39da82 57237-211 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120720 ANDA ANDA079118 Citron Pharma LLC METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 57237-212_1f289eba-949a-4059-8e5c-e3395a546db2 57237-212 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA202096 Citron Pharma LLC MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 57237-213_1f289eba-949a-4059-8e5c-e3395a546db2 57237-213 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA202096 Citron Pharma LLC MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 57237-214_bf0d56f1-d384-4206-99d3-da2deec698a4 57237-214 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20111108 ANDA ANDA200429 Citron Pharma LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 57237-215_bf0d56f1-d384-4206-99d3-da2deec698a4 57237-215 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20111108 ANDA ANDA200429 Citron Pharma LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 57237-216_bf0d56f1-d384-4206-99d3-da2deec698a4 57237-216 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20111108 ANDA ANDA200429 Citron Pharma LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 57237-217_69beac34-395e-4c50-b901-332b07010944 57237-217 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride and Metformin Hydrochloride Pioglitazone Hydrochloride and Metformin Hydrochloride TABLET, FILM COATED ORAL 20130213 ANDA ANDA200823 Citron Pharma LLC PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 500 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 57237-218_69beac34-395e-4c50-b901-332b07010944 57237-218 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride and Metformin Hydrochloride Pioglitazone Hydrochloride and Metformin Hydrochloride TABLET, FILM COATED ORAL 20130213 ANDA ANDA200823 Citron Pharma LLC PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 850 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 57237-219_ad927d81-50c9-4a39-b1ed-87c242a84f9c 57237-219 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA200268 Citron Pharma LLC PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 57237-220_ad927d81-50c9-4a39-b1ed-87c242a84f9c 57237-220 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA200268 Citron Pharma LLC PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 57237-221_ad927d81-50c9-4a39-b1ed-87c242a84f9c 57237-221 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA200268 Citron Pharma LLC PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 57237-222_d5c58fb5-b415-4567-9790-55631705c5cd 57237-222 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Citron Pharma LLC RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-223_d5c58fb5-b415-4567-9790-55631705c5cd 57237-223 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Citron Pharma LLC RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-224_d5c58fb5-b415-4567-9790-55631705c5cd 57237-224 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Citron Pharma LLC RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-225_d5c58fb5-b415-4567-9790-55631705c5cd 57237-225 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Citron Pharma LLC RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 57237-226_adb62990-1d1c-475e-aadc-3922d9aecac0 57237-226 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Citron Pharma LLC RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 57237-227_adb62990-1d1c-475e-aadc-3922d9aecac0 57237-227 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Citron Pharma LLC RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 57237-228_adb62990-1d1c-475e-aadc-3922d9aecac0 57237-228 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Citron Pharma LLC RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 57237-229_adb62990-1d1c-475e-aadc-3922d9aecac0 57237-229 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Citron Pharma LLC RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 57237-230_adb62990-1d1c-475e-aadc-3922d9aecac0 57237-230 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Citron Pharma LLC RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 57237-231_adb62990-1d1c-475e-aadc-3922d9aecac0 57237-231 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Citron Pharma LLC RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 57237-232_e1a3748d-ca73-4e56-95ad-d25189cc346e 57237-232 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Citron Pharma LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 57237-233_e1a3748d-ca73-4e56-95ad-d25189cc346e 57237-233 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Citron Pharma LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 57237-234_056bf333-dcbf-4636-b48f-e2b549d23f13 57237-234 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Citron Pharma LLC STAVUDINE 15 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 57237-235_056bf333-dcbf-4636-b48f-e2b549d23f13 57237-235 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Citron Pharma LLC STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 57237-236_056bf333-dcbf-4636-b48f-e2b549d23f13 57237-236 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Citron Pharma LLC STAVUDINE 30 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 57237-237_056bf333-dcbf-4636-b48f-e2b549d23f13 57237-237 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Citron Pharma LLC STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 57237-238_7f30ad02-f1b9-4976-85b8-3a4d0a61241b 57237-238 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20140331 ANDA ANDA203494 Citron Pharma LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 57237-239_cff46def-c452-49bb-abea-480de8f432bd 57237-239 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080606 ANDA ANDA078829 Citron Pharma LLC ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 57237-240_cff46def-c452-49bb-abea-480de8f432bd 57237-240 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080606 ANDA ANDA078829 Citron Pharma LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 57237-241_33d15753-c39d-4501-b724-7f30e7b299b6 57237-241 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20050919 ANDA ANDA077267 Citron Pharma LLC ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 57237-242_e401ab79-73cc-49fc-8aec-2c7aecb95b34 57237-242 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060314 ANDA ANDA077606 Citron Pharma LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57237-243_e401ab79-73cc-49fc-8aec-2c7aecb95b34 57237-243 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060314 ANDA ANDA077606 Citron Pharma LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57237-244_e401ab79-73cc-49fc-8aec-2c7aecb95b34 57237-244 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060314 ANDA ANDA077606 Citron Pharma LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57237-255_1f289eba-949a-4059-8e5c-e3395a546db2 57237-255 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA202468 Citron Pharma LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 57237-266_8a778c7f-c80a-4673-91d0-b01bb16470a8 57237-266 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20161018 ANDA ANDA071611 Citron Pharma LLC CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 57237-274_bed2e227-8d36-40ea-bbbf-d8793bfda425 57237-274 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine SOLUTION ORAL 20161121 ANDA ANDA077695 Citron Pharma LLC LAMIVUDINE 10 mg/mL Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 57240-2003_603e158b-23cb-4443-beda-8e36c6b390bf 57240-2003 HUMAN OTC DRUG Zippity Doos for Children Rosemary Oil SHAMPOO TOPICAL 20100301 UNAPPROVED HOMEOPATHIC Laurus Enterprises, LLC ROSEMARY OIL 2.49 mg/mL E 20171231 57240-2010_61510e94-444e-4bf0-8676-3ac21616c506 57240-2010 HUMAN OTC DRUG Zippity Doos CONDITIONER FOR CHILDREN Rosemary Oil LIQUID TOPICAL 20100301 UNAPPROVED HOMEOPATHIC Laurus Enterprises, LLC ROSEMARY OIL 2.49 mg/mL E 20171231 57240-2027_9bacf466-7af6-4b04-a9fe-656101bef374 57240-2027 HUMAN OTC DRUG Zippity Doos STYLING FOR CHILDREN Rosemary GEL TOPICAL 20100301 UNAPPROVED HOMEOPATHIC Laurus Enterprises, LLC ROSEMARY .023 mg/mL E 20171231 57240-2034_685a3436-9940-4254-b133-295d0d37d600 57240-2034 HUMAN OTC DRUG Zippity Doos LEAVE-IN DETANGLER FOR CHILDREN Rosemary Oil SPRAY TOPICAL 20100301 UNAPPROVED HOMEOPATHIC Laurus Enterprises, LLC ROSEMARY OIL 2.45 mg/mL E 20171231 57240-2041_394d0c56-a4b2-4acd-8977-ef591a007405 57240-2041 HUMAN OTC DRUG Zippity Doos SHIELD Rosemary LIQUID TOPICAL 20100301 UNAPPROVED HOMEOPATHIC Laurus Enterprises, LLC ROSEMARY 2.49 mg/mL E 20171231 57243-001_7fdb4716-4f9a-4236-a45f-c6a97fa66f10 57243-001 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20151122 OTC MONOGRAPH NOT FINAL part333A Salado Sales Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 57243-016_d38ca65e-ae7f-4cbd-9fb4-5fc3ba2ae093 57243-016 HUMAN OTC DRUG CVP Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Salado Sales, Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 57243-036_1153fdcb-8dc0-4a50-aaeb-8e56c143e5fc 57243-036 HUMAN OTC DRUG Decongestant Nasal oxymetazoline HCl SOLUTION NASAL 20000201 OTC MONOGRAPH FINAL part341 Salado Sales Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 57243-055_82be3ad7-a459-4eba-9ef0-fedc719001ac 57243-055 HUMAN OTC DRUG CVP Antibacterial Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Salado Sales, Inc. BENZALKONIUM CHLORIDE .115 g/1 N 20181231 57243-069_cb217aab-7bb0-48ca-9373-d26ee99aae42 57243-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20030604 OTC MONOGRAPH FINAL part347 Salado Sales, Inc PETROLATUM 1 g/g N 20181231 57243-120_4a9f8454-d28e-49e3-b179-5fe244770ffb 57243-120 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20151215 OTC MONOGRAPH FINAL part333B Salado Sales, Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 57243-157_92922e82-d128-4e99-b487-58bff0729a65 57243-157 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ASPIRIN 325 mg/1 N 20191231 57243-159_616352df-106c-4181-94cf-172422eaba34 57243-159 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 57243-175_691d37d9-7944-495a-89d0-90c36f98004c 57243-175 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 57243-189_d20d47ef-501f-4bec-9c52-47cf85a8c8b2 57243-189 HUMAN OTC DRUG Sleep Diphenhydramine HCl TABLET ORAL 19900410 OTC MONOGRAPH FINAL part338 Salado Sales, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 57243-190_f82bba62-c80e-446d-800e-de1597afe0a0 57243-190 HUMAN OTC DRUG Complete Allergy Medicine Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 57243-226_96b62518-401e-4c08-b2fd-ae36aef50d4a 57243-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 Salado Sales, Inc. CAFFEINE 200 mg/1 N 20181231 57243-235_5b0f593e-05f3-443a-9751-2e0a6080c0f6 57243-235 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 57243-291_3362a1df-db6b-4c1b-a785-c392256a7588 57243-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 ANDA ANDA075010 Salado Sales, Inc. IBUPROFEN 200 mg/1 N 20181231 57243-370_04a5a795-e80e-47e4-91bb-1efcf8f4a90e 57243-370 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Salado Sales Inc. ALCOHOL 70 mL/100mL N 20181231 57243-403_51cf1c7b-2839-4319-a751-e990303eb64b 57243-403 HUMAN OTC DRUG Less Drowsy Formula Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 Salado Sales, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 57243-447_d50b22db-5b6e-40ed-ba84-2b84e8b46d7b 57243-447 HUMAN OTC DRUG Rapid Tabs Acetaminophen TABLET, CHEWABLE ORAL 20050203 20201128 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN 80 mg/1 N 20191231 57243-450_626b6dde-973a-42cc-952b-0f13debbf20f 57243-450 HUMAN OTC DRUG Childrens Chewable Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN 160 mg/1 N 20181231 57243-453_8a18a46f-90a5-4b0e-9f8a-86bd9bd3605a 57243-453 HUMAN OTC DRUG SU PHEDRINE PE Non-Drowsy, Maximum Strength Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20191231 57243-455_cc0f8884-98f9-4e98-a4b8-5d740bc617f0 57243-455 HUMAN OTC DRUG Allergy Multi Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20050628 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 57243-466_ecd03864-0d1f-4533-8bac-d755087b26a3 57243-466 HUMAN OTC DRUG Sinus Congestion and Pain Day, Non-Drowsy Acetaminophen and Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 57243-501_2967e3a3-33bf-45fd-b164-fb845db392e9 57243-501 HUMAN OTC DRUG Nite-Time COLD/FLU ORIGINAL ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20120116 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 57243-502_76dd6980-7316-4c9b-8a8f-fd35c603c879 57243-502 HUMAN OTC DRUG Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE LIQUID ORAL 20120131 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 57243-503_b12153a1-5fdf-412c-b725-8b62f248caad 57243-503 HUMAN OTC DRUG TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20120101 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 57243-506_6c13ab37-66d3-4c8d-9b77-f9f92149931e 57243-506 HUMAN OTC DRUG Daytime Non-Drowsy COLD/FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20120905 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 57243-525_1b2e6ba4-b246-4af3-8b3d-f10cd8104131 57243-525 HUMAN OTC DRUG Allerfed Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20050722 20191025 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 E 20171231 57243-534_924884f8-a32f-404f-a383-a5c866d02918 57243-534 HUMAN OTC DRUG DayTime Multi-Symptom Flu Cold Medicine Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20070919 20180723 OTC MONOGRAPH NOT FINAL part343 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 57243-535_b00809dc-dc28-462c-a18a-3d7b3a10d7e8 57243-535 HUMAN OTC DRUG NightTime Multi-Symptom Flu Cold Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20070910 20180723 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 E 20171231 57243-560_29772e61-38ce-4dff-b9a9-dccb172c2bad 57243-560 HUMAN OTC DRUG Cold-Flu Relief Multi Symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20080329 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 57243-616_7bf31d8f-0a6c-4c71-b8fc-9da8eb67fd41 57243-616 HUMAN OTC DRUG Mucus Relief, Cold, Flu and Sore Throat Maximum Strength, Multi-Symptom Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 57243-620_a5ee1032-edcb-4cc0-9c03-71b6c27b5f04 57243-620 HUMAN OTC DRUG Heartburn Relief 150 Maximum Strength Ranitidine TABLET, FILM COATED ORAL 20130615 20180715 ANDA ANDA200536 Salado Sales, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 E 20171231 57243-641_85e72c6f-518a-4f9f-b4c1-f136da8225f7 57243-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140904 OTC MONOGRAPH NOT FINAL part333A Salado Sales, Inc BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 57243-659_dd47aace-9c28-4186-ae84-aa5cbeb26feb 57243-659 HUMAN OTC DRUG Day Time Multi-Symptom Flu Cold Medicine Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 57243-660_6b99462f-446a-42f6-9ef0-f268dbfe70aa 57243-660 HUMAN OTC DRUG Night Time Multi Symptom Flu Cold Medicine Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Salado Sales, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 57243-664_042f24d3-b1b1-42d9-98b2-8d6e6c326011 57243-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20100604 OTC MONOGRAPH NOT FINAL part356 Salado Sales, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 57243-810_118ab94c-f4be-4ee9-8cc2-2da7137701a7 57243-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20030604 OTC MONOGRAPH NOT FINAL part333A Salado Sales, Inc ISOPROPYL ALCOHOL 500 mg/mL N 20181231 57243-871_1553f2c1-d961-4004-be27-9648b5e09202 57243-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20030604 OTC MONOGRAPH NOT FINAL part333A Salado Sales, Inc HYDROGEN PEROXIDE 30 mg/mL N 20181231 57277-001_b33ce586-7fb1-444d-a222-7fcddd33d9d9 57277-001 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20170921 ANDA ANDA205529 Sanja Pharmaceuticals Company OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 57277-002_b33ce586-7fb1-444d-a222-7fcddd33d9d9 57277-002 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20170921 ANDA ANDA205529 Sanja Pharmaceuticals Company OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 57277-105_09c0db7d-1392-4d2b-9fca-07e8272df7de 57277-105 HUMAN PRESCRIPTION DRUG Carboplatin carboplatin Injection SOLUTION INTRAVENOUS 20160929 ANDA ANDA205487 Sanja Pharmaceuticals Company CARBOPLATIN 50 mg/5mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] E 20171231 57277-106_09c0db7d-1392-4d2b-9fca-07e8272df7de 57277-106 HUMAN PRESCRIPTION DRUG Carboplatin carboplatin Injection SOLUTION INTRAVENOUS 20160929 ANDA ANDA205487 Sanja Pharmaceuticals Company CARBOPLATIN 150 mg/5mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] E 20171231 57277-107_09c0db7d-1392-4d2b-9fca-07e8272df7de 57277-107 HUMAN PRESCRIPTION DRUG Carboplatin carboplatin Injection SOLUTION INTRAVENOUS 20160929 ANDA ANDA205487 Sanja Pharmaceuticals Company CARBOPLATIN 450 mg/5mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] E 20171231 57278-314_5f9a354f-4562-7561-e053-2991aa0acf9a 57278-314 HUMAN PRESCRIPTION DRUG Triferic FERRIC PYROPHOSPHATE SOLUTION PARENTERAL 20150206 NDA NDA206317 Rockwell Medical, Inc FERRIC PYROPHOSPHATE CITRATE 5.44 mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 57278-315_5f9a354f-4562-7561-e053-2991aa0acf9a 57278-315 HUMAN PRESCRIPTION DRUG Triferic FERRIC PYROPHOSPHATE CITRATE POWDER PARENTERAL 20160425 NDA NDA208551 Rockwell Medical, Inc FERRIC PYROPHOSPHATE CITRATE 272 mg/1 Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 57278-316_5f9a354f-4562-7561-e053-2991aa0acf9a 57278-316 HUMAN PRESCRIPTION DRUG Triferic Ferric Pyrophosphate Citrate SOLUTION HEMODIALYSIS; PARENTERAL 20150904 NDA NDA206317 Rockwell Medical, Inc FERRIC PYROPHOSPHATE CITRATE 272 mg/50mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 57285-100_7aff6e22-67f3-408c-adcc-e2978f1c1508 57285-100 HUMAN OTC DRUG Anti Itch Balm Peppermint Oil OINTMENT TOPICAL 20130329 UNAPPROVED DRUG OTHER US ORGANIC GROUP CORP PEPPERMINT OIL .0952 g/28g E 20171231 57287-100_fe914341-484d-4972-bbde-b324816c10cb 57287-100 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20130311 NDA NDA206023 Jernigan Healthcare, Inc. OXYGEN 99 L/100L N 20181231 57297-101_a3f79bb0-6766-40fd-9817-4b84ec840930 57297-101 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 LUPIN LIMITED HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-102_a3f79bb0-6766-40fd-9817-4b84ec840930 57297-102 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 LUPIN LIMITED HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-103_a3f79bb0-6766-40fd-9817-4b84ec840930 57297-103 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 LUPIN LIMITED HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-104_a3f79bb0-6766-40fd-9817-4b84ec840930 57297-104 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 LUPIN LIMITED HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-105_a3f79bb0-6766-40fd-9817-4b84ec840930 57297-105 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 LUPIN LIMITED HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-112_93623b6f-02f0-4b27-bd37-b2bc3f354c91 57297-112 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 LUPIN LIMITED LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 57297-113_93623b6f-02f0-4b27-bd37-b2bc3f354c91 57297-113 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 LUPIN LIMITED LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 57297-114_93623b6f-02f0-4b27-bd37-b2bc3f354c91 57297-114 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 LUPIN LIMITED LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 57297-115_93623b6f-02f0-4b27-bd37-b2bc3f354c91 57297-115 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA090025 LUPIN LIMITED LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 57297-117_65e29aee-eead-4151-97e0-cb84b8ff31b2 57297-117 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091399 LUPIN LIMITED LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 57297-118_65e29aee-eead-4151-97e0-cb84b8ff31b2 57297-118 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091399 LUPIN LIMITED LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 57297-121_8eef6534-0a3a-4f29-9dcd-9dac12d02722 57297-121 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 LUPIN LIMITED CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-122_8eef6534-0a3a-4f29-9dcd-9dac12d02722 57297-122 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 LUPIN LIMITED CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-134_e5df4c54-c95e-4dba-b880-ef39b5d4724e 57297-134 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20150909 ANDA ANDA202127 LUPIN LIMITED CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 57297-160_b6353b0e-9818-46b3-81fd-d9dae8bf62c6 57297-160 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150722 ANDA ANDA065398 LUPIN LIMITED AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 57297-161_b6353b0e-9818-46b3-81fd-d9dae8bf62c6 57297-161 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150722 ANDA ANDA065399 LUPIN LIMITED AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 57297-162_0d4e2766-a243-44a9-801e-b4e4abcc59a2 57297-162 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150722 ANDA ANDA065400 LUPIN LIMITED AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 57297-180_1ce9b483-1b62-4524-ac09-66c9102b42cb 57297-180 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080423 ANDA ANDA065392 LUPIN LIMITED CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-201_900acfe4-3bce-45e2-ad28-9438bf36fa6c 57297-201 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET ORAL 20080401 ANDA ANDA065130 LUPIN LIMITED CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-203_900acfe4-3bce-45e2-ad28-9438bf36fa6c 57297-203 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET, CHEWABLE ORAL 20121205 ANDA ANDA065380 LUPIN LIMITED CEFIXIME 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-205_900acfe4-3bce-45e2-ad28-9438bf36fa6c 57297-205 HUMAN PRESCRIPTION DRUG SUPRAX cefixime TABLET, CHEWABLE ORAL 20121205 ANDA ANDA065380 LUPIN LIMITED CEFIXIME 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-206_900acfe4-3bce-45e2-ad28-9438bf36fa6c 57297-206 HUMAN PRESCRIPTION DRUG SUPRAX cefixime POWDER, FOR SUSPENSION ORAL 20070601 ANDA ANDA065355 LUPIN LIMITED CEFIXIME 200 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-207_900acfe4-3bce-45e2-ad28-9438bf36fa6c 57297-207 HUMAN PRESCRIPTION DRUG SUPRAX cefixime POWDER, FOR SUSPENSION ORAL 20130315 NDA NDA202091 LUPIN LIMITED CEFIXIME 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-208_900acfe4-3bce-45e2-ad28-9438bf36fa6c 57297-208 HUMAN PRESCRIPTION DRUG SUPRAX cefixime CAPSULE ORAL 20130315 NDA NDA203195 LUPIN LIMITED CEFIXIME 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-215_40e5d119-b44e-4d48-afe6-8406fb57c488 57297-215 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA078245 LUPIN LIMITED HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-216_40e5d119-b44e-4d48-afe6-8406fb57c488 57297-216 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA078245 LUPIN LIMITED HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-217_40e5d119-b44e-4d48-afe6-8406fb57c488 57297-217 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA078245 LUPIN LIMITED HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-221_e9acee42-88c8-44f7-b6c5-0719c9d026bc 57297-221 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20140320 ANDA ANDA090860 LUPIN LIMITED NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 57297-222_e9acee42-88c8-44f7-b6c5-0719c9d026bc 57297-222 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20140320 ANDA ANDA090892 LUPIN LIMITED NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 57297-223_e9acee42-88c8-44f7-b6c5-0719c9d026bc 57297-223 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20140320 ANDA ANDA090446 LUPIN LIMITED NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 57297-284_b301e8a1-05e8-4179-90de-a8c81f007b96 57297-284 HUMAN PRESCRIPTION DRUG LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE AND ZIDOVUDINE TABLET ORAL 20120515 ANDA ANDA090246 LUPIN LIMITED LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 57297-286_24150f6d-980b-4a8f-bf76-6308c091ed56 57297-286 HUMAN PRESCRIPTION DRUG ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLET ORAL 20131217 ANDA ANDA202912 LUPIN LIMITED LAMIVUDINE; ZIDOVUDINE; ABACAVIR SULFATE 150; 300; 300 mg/1; mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 57297-302_33afa15e-6c42-49e0-afc1-c3c5fb59e7ee 57297-302 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20030725 ANDA ANDA065135 LUPIN LIMITED CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-303_33afa15e-6c42-49e0-afc1-c3c5fb59e7ee 57297-303 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20030725 ANDA ANDA065135 LUPIN LIMITED CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-314_fa6028eb-f295-41ab-91ce-d0697591de83 57297-314 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100416 ANDA ANDA090444 LUPIN LIMITED IMIPRAMINE PAMOATE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 57297-315_fa6028eb-f295-41ab-91ce-d0697591de83 57297-315 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100416 ANDA ANDA090444 LUPIN LIMITED IMIPRAMINE PAMOATE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 57297-316_fa6028eb-f295-41ab-91ce-d0697591de83 57297-316 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100416 ANDA ANDA090444 LUPIN LIMITED IMIPRAMINE PAMOATE 125 mg/1 Tricyclic Antidepressant [EPC] E 20171231 57297-317_fa6028eb-f295-41ab-91ce-d0697591de83 57297-317 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100416 ANDA ANDA090444 LUPIN LIMITED IMIPRAMINE PAMOATE 150 mg/1 Tricyclic Antidepressant [EPC] E 20171231 57297-331_105d5a2d-7f6a-439e-bc9c-3d81b3077e74 57297-331 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 LUPIN LIMITED ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 57297-332_105d5a2d-7f6a-439e-bc9c-3d81b3077e74 57297-332 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 LUPIN LIMITED ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] E 20171231 57297-333_105d5a2d-7f6a-439e-bc9c-3d81b3077e74 57297-333 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 LUPIN LIMITED ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] E 20171231 57297-334_105d5a2d-7f6a-439e-bc9c-3d81b3077e74 57297-334 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 LUPIN LIMITED ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] E 20171231 57297-351_eb14d261-675a-418d-a62d-81453d423180 57297-351 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 LUPIN LIMITED SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 57297-352_eb14d261-675a-418d-a62d-81453d423180 57297-352 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 LUPIN LIMITED SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 57297-353_eb14d261-675a-418d-a62d-81453d423180 57297-353 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 LUPIN LIMITED SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 57297-360_a459212d-bef4-4911-b994-5f1c7b28b512 57297-360 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20120713 ANDA ANDA090856 LUPIN LIMITED FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] E 20171231 57297-361_a459212d-bef4-4911-b994-5f1c7b28b512 57297-361 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20120713 ANDA ANDA090856 LUPIN LIMITED FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] E 20171231 57297-401_7d716a14-301a-440b-8205-7e14542ad016 57297-401 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL POWDER, FOR SUSPENSION ORAL 20051201 ANDA ANDA065261 LUPIN LIMITED CEFPROZIL 125 mg/5mL E 20171231 57297-402_7d716a14-301a-440b-8205-7e14542ad016 57297-402 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL POWDER, FOR SUSPENSION ORAL 20051201 ANDA ANDA065261 LUPIN LIMITED CEFPROZIL 250 mg/5mL E 20171231 57297-403_e4b9c8a3-072a-457c-be1e-fcea028637b9 57297-403 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20051201 ANDA ANDA065276 LUPIN LIMITED CEFPROZIL 250 mg/1 E 20171231 57297-404_e4b9c8a3-072a-457c-be1e-fcea028637b9 57297-404 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20051201 ANDA ANDA065276 LUPIN LIMITED CEFPROZIL 500 mg/1 E 20171231 57297-410_d68faa18-807b-4fc0-808f-b00378a68a41 57297-410 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121023 ANDA ANDA201531 LUPIN LIMITED IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-411_d68faa18-807b-4fc0-808f-b00378a68a41 57297-411 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121023 ANDA ANDA201531 LUPIN LIMITED IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-412_d68faa18-807b-4fc0-808f-b00378a68a41 57297-412 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121023 ANDA ANDA201531 LUPIN LIMITED IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-413_ac69bbca-81f4-4896-bb7e-df0a4428fe42 57297-413 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130404 ANDA ANDA201524 LUPIN LIMITED HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-414_ac69bbca-81f4-4896-bb7e-df0a4428fe42 57297-414 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130404 ANDA ANDA201524 LUPIN LIMITED HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-429_7e93fb29-97d9-4fa1-bdec-75eea81143c9 57297-429 HUMAN PRESCRIPTION DRUG bimatoprost bimatoprost SOLUTION/ DROPS OPHTHALMIC 20150513 ANDA ANDA203991 LUPIN LIMITED BIMATOPROST .3 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] E 20171231 57297-435_acc3e700-1d57-4e9f-97b4-a61b2e99814e 57297-435 HUMAN PRESCRIPTION DRUG Gatifloxacin Gatifloxacin SOLUTION/ DROPS OPHTHALMIC 20131001 ANDA ANDA202653 LUPIN LIMITED GATIFLOXACIN 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 57297-445_28b08037-0fdb-4dd9-a3e4-e9bba5ca8948 57297-445 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 LUPIN LIMITED QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] E 20171231 57297-446_28b08037-0fdb-4dd9-a3e4-e9bba5ca8948 57297-446 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 LUPIN LIMITED QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 57297-447_28b08037-0fdb-4dd9-a3e4-e9bba5ca8948 57297-447 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 LUPIN LIMITED QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 57297-448_28b08037-0fdb-4dd9-a3e4-e9bba5ca8948 57297-448 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 LUPIN LIMITED QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 57297-449_28b08037-0fdb-4dd9-a3e4-e9bba5ca8948 57297-449 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 LUPIN LIMITED QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] E 20171231 57297-450_28b08037-0fdb-4dd9-a3e4-e9bba5ca8948 57297-450 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 LUPIN LIMITED QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] E 20171231 57297-464_c4be39fe-ec4b-4d8c-b540-9311111dac1c 57297-464 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20151202 ANDA ANDA078103 LUPIN LIMITED SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 57297-465_c4be39fe-ec4b-4d8c-b540-9311111dac1c 57297-465 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20151202 ANDA ANDA078103 LUPIN LIMITED SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 57297-478_c4be39fe-ec4b-4d8c-b540-9311111dac1c 57297-478 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070612 ANDA ANDA078103 LUPIN LIMITED SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 57297-479_c4be39fe-ec4b-4d8c-b540-9311111dac1c 57297-479 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070614 ANDA ANDA078103 LUPIN LIMITED SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 57297-480_c4be39fe-ec4b-4d8c-b540-9311111dac1c 57297-480 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20151123 ANDA ANDA078103 LUPIN LIMITED SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 57297-481_c4be39fe-ec4b-4d8c-b540-9311111dac1c 57297-481 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20151123 ANDA ANDA078103 LUPIN LIMITED SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 57297-482_c4be39fe-ec4b-4d8c-b540-9311111dac1c 57297-482 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20090714 ANDA ANDA078103 LUPIN LIMITED SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 57297-512_86760e35-f60a-4377-9d08-53855e96809f 57297-512 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 LUPIN LIMITED LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57297-513_86760e35-f60a-4377-9d08-53855e96809f 57297-513 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 LUPIN LIMITED LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57297-514_86760e35-f60a-4377-9d08-53855e96809f 57297-514 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 LUPIN LIMITED LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57297-515_86760e35-f60a-4377-9d08-53855e96809f 57297-515 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 LUPIN LIMITED LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57297-516_86760e35-f60a-4377-9d08-53855e96809f 57297-516 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 LUPIN LIMITED LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57297-517_86760e35-f60a-4377-9d08-53855e96809f 57297-517 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 LUPIN LIMITED LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57297-518_cb5ca667-3142-46d8-8537-c4510571eb22 57297-518 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20061004 ANDA ANDA077912 LUPIN LIMITED HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57297-519_cb5ca667-3142-46d8-8537-c4510571eb22 57297-519 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 LUPIN LIMITED HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57297-520_cb5ca667-3142-46d8-8537-c4510571eb22 57297-520 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 LUPIN LIMITED HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57297-611_58528d70-4576-4005-a6ac-6c7807920c7e 57297-611 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 LUPIN LIMITED CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-622_58528d70-4576-4005-a6ac-6c7807920c7e 57297-622 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 LUPIN LIMITED CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-633_58528d70-4576-4005-a6ac-6c7807920c7e 57297-633 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 LUPIN LIMITED CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-644_58528d70-4576-4005-a6ac-6c7807920c7e 57297-644 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 LUPIN LIMITED CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-711_95651f98-66e5-4ebc-bfd8-3853eec21391 57297-711 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070501 ANDA ANDA065264 LUPIN LIMITED CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-722_231debe8-1d48-478f-adfd-8bf7f50c0088 57297-722 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 LUPIN LIMITED CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-723_231debe8-1d48-478f-adfd-8bf7f50c0088 57297-723 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 LUPIN LIMITED CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 57297-764_40b74a8d-c376-4e6c-92cb-22604cbb1317 57297-764 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA090245 LUPIN LIMITED AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-765_40b74a8d-c376-4e6c-92cb-22604cbb1317 57297-765 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA090245 LUPIN LIMITED AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-766_40b74a8d-c376-4e6c-92cb-22604cbb1317 57297-766 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA090245 LUPIN LIMITED AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-767_40b74a8d-c376-4e6c-92cb-22604cbb1317 57297-767 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA090245 LUPIN LIMITED AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 57297-771_b17081c0-a99a-48eb-be9f-494591f7466c 57297-771 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150603 ANDA ANDA200797 LUPIN LIMITED AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 57297-772_b17081c0-a99a-48eb-be9f-494591f7466c 57297-772 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150603 ANDA ANDA200797 LUPIN LIMITED AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 57297-773_b17081c0-a99a-48eb-be9f-494591f7466c 57297-773 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150603 ANDA ANDA200797 LUPIN LIMITED AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 57297-774_b17081c0-a99a-48eb-be9f-494591f7466c 57297-774 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150603 ANDA ANDA200797 LUPIN LIMITED AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 57297-775_b17081c0-a99a-48eb-be9f-494591f7466c 57297-775 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150603 ANDA ANDA200797 LUPIN LIMITED AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 320; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 57297-798_7a1a98c3-91ae-4852-be41-c119160231c3 57297-798 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20160118 ANDA ANDA203002 LUPIN LIMITED POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 57297-799_7a1a98c3-91ae-4852-be41-c119160231c3 57297-799 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20160118 ANDA ANDA203002 LUPIN LIMITED POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 57297-837_513cc746-3848-420f-b52c-6e89455b8717 57297-837 HUMAN PRESCRIPTION DRUG TRI-LO-MARZIA norgestimate and ethinyl estradiol KIT 20160118 ANDA ANDA200541 LUPIN LIMITED E 20171231 57297-843_4f3cf691-0ecd-4399-9aff-7ac7173cf74c 57297-843 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol Levonorgestrel and Ethinyl Estradiol KIT 20121024 ANDA ANDA091440 LUPIN LIMITED E 20171231 57297-844_8acb22c2-a74c-4369-84e7-c6f5f1b17502 57297-844 HUMAN PRESCRIPTION DRUG Kurvelo Levonorgestrel and Ethinyl Estradiol KIT 20121026 ANDA ANDA091408 LUPIN LIMITED E 20171231 57297-848_f79de20e-4e48-4b93-b285-d7d388db1c62 57297-848 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol levonorgestrel and ethinyl estradiol KIT 20111202 ANDA ANDA091674 LUPIN LIMITED E 20171231 57297-853_5779cd78-b5b7-43fe-a866-bd2f2533f70b 57297-853 HUMAN OTC DRUG Fallback Solo levonorgestrel TABLET ORAL 20140722 ANDA ANDA201446 LUPIN LIMITED LEVONORGESTREL 1.5 mg/1 E 20171231 57297-854_4146272b-0cd7-479c-b169-b6ebe242578f 57297-854 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol Levonorgestrel and Ethinyl Estradiol KIT 20130320 ANDA ANDA091425 LUPIN LIMITED E 20171231 57297-857_9c0503d4-6400-4daa-8fc9-0665324c599b 57297-857 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol Levonorgestrel and Ethinyl Estradiol KIT 20151203 ANDA ANDA200248 LUPIN LIMITED E 20171231 57297-875_acb1dea2-0653-45fa-bf1f-38cab18a81bd 57297-875 HUMAN PRESCRIPTION DRUG Vyfemla norethindrone and ethinyl estradiol KIT 20131223 ANDA ANDA201886 LUPIN LIMITED E 20171231 57297-876_200f4b92-168d-4953-9d11-fb98aa8dc398 57297-876 HUMAN PRESCRIPTION DRUG NORETHINDRONE NORETHINDRONE TABLET ORAL 20111110 ANDA ANDA091325 LUPIN LIMITED NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 57297-877_f598a2bd-2e92-41c4-925a-b52777eacd64 57297-877 HUMAN PRESCRIPTION DRUG Jencycla norethindrone TABLET ORAL 20130508 ANDA ANDA091323 LUPIN LIMITED NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 57297-880_acd01b21-6575-498a-983f-59782f499492 57297-880 HUMAN PRESCRIPTION DRUG Bekyree desogestrel and ethinyl estradiol and ethinyl estradiol KIT 20151026 ANDA ANDA202226 LUPIN LIMITED E 20171231 57297-882_8085fdb4-0f64-48eb-b74b-5879ac2c6bb8 57297-882 HUMAN PRESCRIPTION DRUG ENSKYCE desogestrel and ethinyl estradiol KIT 20130507 ANDA ANDA201887 LUPIN LIMITED E 20171231 57297-886_b43c5bab-0370-48d2-be3a-2d0790e4793d 57297-886 HUMAN PRESCRIPTION DRUG Nikki drospirenone and ethinyl estradiol KIT 20140730 ANDA ANDA201661 LUPIN LIMITED E 20171231 57297-902_707b2884-c912-43b7-830e-520e3f3b3e0e 57297-902 HUMAN PRESCRIPTION DRUG DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE AND ETHINYL ESTRADIOL KIT 20121231 ANDA ANDA201663 LUPIN LIMITED E 20171231 57297-903_bc86368c-01da-4ef7-9a7e-7d2051b0de7c 57297-903 HUMAN PRESCRIPTION DRUG Kaitlib Fe norethindrone and ethinyl estradiol KIT 20151217 ANDA ANDA203448 LUPIN LIMITED E 20171231 57319-065_580b36d2-1400-4096-aff1-cbc1f6d0ad4c 57319-065 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 19960726 ANDA ANDA040069 Phoenix Pharmaceutical, Inc. DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 57319-307_2a1d77e9-c706-4d9b-9745-e93ef4919c8a 57319-307 HUMAN PRESCRIPTION DRUG NPD Neomycin sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 19940725 ANDA ANDA064063 Phoenix Pharmaceutical, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 57319-343_f7504b22-2d9e-4e2c-a308-1469bd5a1bab 57319-343 HUMAN PRESCRIPTION DRUG Triple Antibiotic Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc OINTMENT OPHTHALMIC 19951030 ANDA ANDA064064 Phoenix Pharmaceutical, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] E 20171231 57319-344_8b45f06d-ad0b-447a-ab1d-14cab8ca4043 57319-344 HUMAN PRESCRIPTION DRUG Triple Antibiotic HC Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone OINTMENT OPHTHALMIC 19951030 ANDA ANDA064068 Phoenix Pharmaceutical, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE 3.5; 10000; 400; 10 mg/g; [USP'U]/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 57319-347_61b2cb3a-9512-48a0-a01d-2cacebeae7fe 57319-347 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 Phoenix Pharmaceutical, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 57329-010_b9cbc519-8615-43a5-939e-0e2763e2d5ee 57329-010 HUMAN OTC DRUG THERAFREEZE MENTHOL GEL TOPICAL 20130808 OTC MONOGRAPH FINAL part341 Astrum Pharma MENTHOL 60 mg/mL E 20171231 57337-000_0d26bd16-503b-49f5-a459-f48483d021b5 57337-000 HUMAN OTC DRUG XtraCare instant Hand Sanitizer Original ALCOHOL LIQUID TOPICAL 20130207 OTC MONOGRAPH FINAL part333E Rejoice International ALCOHOL 62 mL/100mL E 20171231 57337-001_37a8e424-f63f-4cc9-bca4-c5ccf681a9dc 57337-001 HUMAN OTC DRUG XtraCare instant Hand Sanitizer ALCOHOL SPRAY TOPICAL 20130208 OTC MONOGRAPH FINAL part333E Rejoice International ALCOHOL 62 mL/100mL E 20171231 57337-002_96d9a53e-e345-4716-b1d2-9f87276ab833 57337-002 HUMAN OTC DRUG XtraCare instant Hand Sanitizer Aloe Vera ALCOHOL LIQUID TOPICAL 20130208 OTC MONOGRAPH FINAL part333E Rejoice International ALCOHOL 62 mL/100mL E 20171231 57337-003_f3d5c3f4-d347-41fe-836f-81ec8e750ff0 57337-003 HUMAN OTC DRUG XtraCare instant Hand Sanitizer Cocoa Butter ALCOHOL LIQUID TOPICAL 20130208 OTC MONOGRAPH FINAL part333E Rejoice International ALCOHOL 62 mL/100mL E 20171231 57337-012_a9f4454e-4415-4de2-8f44-73b9d418e5c4 57337-012 HUMAN OTC DRUG Instant Hand Sanitizer Aloe Vera Ethyl Alcohol GEL TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. ALCOHOL 146 mL/236mL N 20181231 57337-013_ac96fab0-e97b-4051-9b3e-3ba26f3d5aae 57337-013 HUMAN OTC DRUG Instant Hand Sanitizer - Ice Clear Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. ALCOHOL 37 mL/60mL N 20181231 57337-014_5a245e41-a03a-4e93-8f9f-c8d1cb2eaf54 57337-014 HUMAN OTC DRUG Instant Hand Sanitizer - Clear Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. ALCOHOL 147 mL/237mL N 20181231 57337-015_2bc1bbb6-974d-4c5c-9c09-a2cc48150d49 57337-015 HUMAN OTC DRUG Instant Hand Sanitizer - Cocoa Butter Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. ALCOHOL 147 mL/237mL N 20181231 57337-016_9ec5a404-bf2a-4f23-bbd1-6834a74767fb 57337-016 HUMAN OTC DRUG Liquid Hand Cleanse Triclosan GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. TRICLOSAN 10 mg/500mg N 20181231 57337-017_cd9b5377-d1b7-4489-a177-e063e22f33fd 57337-017 HUMAN OTC DRUG Instant Hand Sanitizer - Original Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. ALCOHOL 33 mL/53mL N 20181231 57337-018_08311c94-3638-4e1f-8ab1-0758a514efa8 57337-018 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. ALCOHOL 6 mL/10mL N 20181231 57337-020_048b18ef-f03e-4be7-af8b-58f69460ae35 57337-020 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Mountain Spring Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. TRICLOSAN 3.3 mg/221mL N 20181231 57337-021_12631f4d-dd29-4a3f-b2dc-d4969a093f8b 57337-021 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Original Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. TRICLOSAN 3.3 mg/221mL N 20181231 57337-022_79cb1808-3dc2-40bf-a7cb-136ab4bf8bfb 57337-022 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Original Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. TRICLOSAN 6.6 1/443mL N 20181231 57337-023_5127744e-1fdc-4f23-bff6-695aa38b989e 57337-023 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate Triclosan SOAP TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. TRICLOSAN 3.3 mg/221mL N 20181231 57337-024_f4c80e21-65c0-48e1-916e-35efffa70a2e 57337-024 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse Coconut and Shea Butter PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 20 mg/400mg N 20181231 57337-025_e97c3200-3fc9-43fa-a4c1-fdeb12914ebe 57337-025 HUMAN OTC DRUG XtraCare Anti-Dandruff Conditioner Coconut and Shea Butter PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 20 mg/400mg N 20181231 57337-026_1899b545-beb0-491d-ba9e-8758006ef10e 57337-026 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptus PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 20 mg/400mg N 20181231 57337-027_922fb746-e59e-4b04-a3cc-e1aa3e01923e 57337-027 HUMAN OTC DRUG XtraCare Anti-Dandruff Conditioner mint and eucalyptus PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 20 mg/400mg N 20181231 57337-028_48fd4bfb-922a-284d-e054-00144ff8d46c 57337-028 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse for normal hair PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 20 mg/400mg N 20181231 57337-029_48fd4bfb-922b-284d-e054-00144ff8d46c 57337-029 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse for sensitive hair PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 20 mg/400mg N 20181231 57337-030_4f825e24-1934-41d0-bb3f-f7881a537400 57337-030 HUMAN OTC DRUG Acne Body Wash Salicylic Acid GEL TOPICAL 20131118 OTC MONOGRAPH FINAL part333D Rejoice International SALICYLIC ACID 7 mg/354mg N 20181231 57337-031_7dbca551-7304-4523-ad72-e3f7276790c9 57337-031 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Salicylic Acid GEL TOPICAL 20131118 OTC MONOGRAPH FINAL part333D Rejoice International SALICYLIC ACID 3 g/150g N 20181231 57337-032_f0209564-80e1-4a5b-8e71-dd0f2002824e 57337-032 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Tea Tree Oil Salicylic Acid GEL TOPICAL 20131120 OTC MONOGRAPH FINAL part333D Rejoice International SALICYLIC ACID 3 g/150g N 20181231 57337-033_73a58c01-f979-412f-b1a1-95ec0a90e723 57337-033 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Facial Cleanser Grapefruit Salicylic Acid GEL TOPICAL 20131121 OTC MONOGRAPH FINAL part333D Rejoice International SALICYLIC ACID 4 mg/177mg N 20181231 57337-034_36c99b62-78f2-4854-949d-e8d828928c9c 57337-034 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Facial Cleanser Tea Tree Oil Salicylic Acid GEL TOPICAL 20131121 OTC MONOGRAPH FINAL part333D Rejoice International SALICYLIC ACID 4 mg/177mg N 20181231 57337-035_7826d2dc-7935-4752-aa56-1f253eded404 57337-035 HUMAN OTC DRUG XtraCare Deep Cleaning Astringent Salicylic Acid GEL TOPICAL 20131126 OTC MONOGRAPH FINAL part333D Rejoice International SALICYLIC ACID 5 mg/237mg N 20181231 57337-036_35e5c7d9-ccc4-4880-9c18-a392e6fe76b6 57337-036 HUMAN OTC DRUG XtraCare Foaming Facial Cleanser Triclosan GEL TOPICAL 20131126 OTC MONOGRAPH NOT FINAL part333A Rejoice International TRICLOSAN 1 mg/237mg N 20181231 57337-037_24af7c19-38e2-461a-8b18-5887d237fa08 57337-037 HUMAN OTC DRUG XtraCare Skin Relief Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 Rejoice International DIMETHICONE 5 mg/354mg N 20181231 57337-038_7424ddf3-504b-45a7-816c-d78bdc0ff239 57337-038 HUMAN OTC DRUG XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 Rejoice International DIMETHICONE 5 mg/354mg N 20181231 57337-039_379985e3-ff56-40a9-b145-8bc5adbd92aa 57337-039 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Cocoa Butter Enriched Petroleum CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part347 Rejoice International PETROLATUM 59 g/198g N 20181231 57337-040_1e4649e1-7bbc-4d75-8a47-8ec6c409a113 57337-040 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Vitamin E enriched Petrolatum CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part347 Rejoice International PETROLATUM 59 g/198g N 20181231 57337-041_44ea82bf-551e-4cd8-ba23-81804b6f8199 57337-041 HUMAN OTC DRUG XtraCare Dry Fresh Invisible Solid Aluminum Chlorohydrate CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part350 Rejoice International ALUMINUM CHLOROHYDRATE 11 g/57g N 20181231 57337-042_1fd9d74e-e977-440b-bd9f-0fe1bee6582c 57337-042 HUMAN OTC DRUG XtraCare Invisible Solid Lady Stick Powder Fresh Aluminum Chlorohydrate CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part350 Rejoice International ALUMINUM CHLOROHYDRATE 11 g/57g N 20181231 57337-043_6ac53718-6d24-4d8a-ac64-997efa2c750b 57337-043 HUMAN OTC DRUG XtraCare Hand Sanitizer Moisturize with Vitamin E Ethyl Alcohol GEL TOPICAL 20140124 OTC MONOGRAPH NOT FINAL part333E Rejoice International ALCOHOL 146 g/236g N 20181231 57337-044_32d6c7d3-0d3d-4a91-a296-1392a56b80cd 57337-044 HUMAN OTC DRUG XtraCare Hand Sanitizer Moisurize with Vitamin E and Aloe Ethyl Alcohol GEL TOPICAL 20140124 OTC MONOGRAPH NOT FINAL part333E Rejoice International ALCOHOL 146 g/236g N 20181231 57337-045_0f600ad7-8573-4cca-9a6c-2549c683ca96 57337-045 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower Benzalkonium Chloride LIQUID TOPICAL 20140124 OTC MONOGRAPH NOT FINAL part333A Rejoice International BENZALKONIUM CHLORIDE .5 g/444g N 20181231 57337-046_1971ba1c-5cc6-44c7-92b7-d9827699085c 57337-046 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast Benzalkonium Chloride SOAP TOPICAL 20140128 OTC MONOGRAPH NOT FINAL part333A Rejoice International BENZALKONIUM CHLORIDE .5 g/444g N 20181231 57337-047_c88fb5d4-673d-4dec-bae5-cc46307ad054 57337-047 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Rejoice International BENZALKONIUM CHLORIDE .2 g/221g N 20181231 57337-048_63f0c7f6-0e89-4a70-8fdb-a749f97d08cd 57337-048 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Wild Berry Blast Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Rejoice International BENZALKONIUM CHLORIDE .2 g/221g N 20181231 57337-049_fed4acc5-4e41-4188-b2ff-01280ea0778c 57337-049 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Rejoice International BENZALKONIUM CHLORIDE .2 g/221g N 20181231 57337-050_782079ab-af66-4ce1-a6d8-b2a0ddb7f3d1 57337-050 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Rejoice International BENZALKONIUM CHLORIDE .5 g/444g N 20181231 57337-051_a99339b7-9a88-4021-88a5-ebbe7ad1a56a 57337-051 HUMAN OTC DRUG XtraCare Vaporizing Chest Rub Camphor, Menthol GEL TOPICAL 20140130 OTC MONOGRAPH FINAL part341 Rejoice International CAMPHOR (NATURAL); MENTHOL 5; 1 g/113g; g/113g N 20181231 57337-052_49849165-9139-0c56-e054-00144ff88e88 57337-052 HUMAN OTC DRUG XtraCare Ice Cold Topical Analgesic Gel Menthol GEL TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part348 Rejoice International MENTHOL 3 g/227g N 20181231 57337-053_c3d3a197-dc75-4905-96eb-04fa69b499bb 57337-053 HUMAN OTC DRUG XtraCare Dandruff Hair Wash Salicylic Acid SHAMPOO TOPICAL 20140205 OTC MONOGRAPH FINAL part358H Rejoice International SALICYLIC ACID 10 g/325g N 20181231 57337-054_abd593b8-47f4-4f3e-a34a-29770632d7f1 57337-054 HUMAN OTC DRUG XtraCare Skin Relief Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 Rejoice International DIMETHICONE 3 g/227g N 20181231 57337-055_24d3cab6-04ef-4179-9b9f-c4d0b8cd222b 57337-055 HUMAN OTC DRUG XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 Rejoice International DIMETHICONE 3 g/227g N 20181231 57337-056_565564c0-ba88-54ba-e054-00144ff88e88 57337-056 HUMAN OTC DRUG XtraCare Antifungal Foot Tolnaftate SPRAY TOPICAL 20140211 OTC MONOGRAPH FINAL part333C Rejoice International TOLNAFTATE 1 g/100g N 20181231 57337-057_1715ef4a-472c-41b7-ac2b-3dc5ce66bf86 57337-057 HUMAN OTC DRUG XtraCare Foaming Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E Rejoice International BENZALKONIUM CHLORIDE 3 g/207g N 20181231 57337-058_d683a1e2-7f07-4f34-b527-a4bd8c10c412 57337-058 HUMAN OTC DRUG XtraCare Instant Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E Rejoice International ALCOHOL 37 g/60g N 20181231 57337-059_568b03d3-e2c9-40ee-afb3-3e23b2fe4675 57337-059 HUMAN OTC DRUG XtraCare Instant Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E Rejoice International ALCOHOL 37 g/60g N 20181231 57337-060_a2824ba7-1e51-4b7a-b38e-ed228eed7110 57337-060 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Petrolatum JELLY TOPICAL 20140218 OTC MONOGRAPH FINAL part347 Rejoice International PETROLATUM 38 g/127g N 20181231 57337-061_794765b6-47f3-48e4-ae9d-15ab5963a2da 57337-061 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Petrolatum JELLY TOPICAL 20140218 OTC MONOGRAPH FINAL part347 Rejoice International PETROLATUM 38 g/127g N 20181231 57337-062_9c6cabdc-86c3-4e47-bf37-670e5c8ce67d 57337-062 HUMAN OTC DRUG XtraCare Wet Wipes Benzethonium Chloride SWAB TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part333E Rejoice International BENZETHONIUM CHLORIDE 3 mg/100mg N 20181231 57337-064_b2a3809d-ae5f-4d2b-bcb1-093e909c8768 57337-064 HUMAN OTC DRUG XtraCare 2 in 1 Hair Cleanse and Condition Coconut Water Pyrithione Zinc SHAMPOO TOPICAL 20140827 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 2 g/100g N 20181231 57337-065_850df0ef-803b-4c2c-a095-31f69d8e59e9 57337-065 HUMAN OTC DRUG XtraCare 2 in 1 Hair Cleanse and Condition Green Apple Pyrithione Zinc SHAMPOO TOPICAL 20140827 OTC MONOGRAPH FINAL part358H Rejoice International Inc. PYRITHIONE ZINC 2 g/100g N 20181231 57337-066_db0e2318-ddc2-4d1c-a269-ed3c5d5ca9f1 57337-066 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part333E Rejoice International BENZETHONIUM CHLORIDE .3 g/1 N 20181231 57337-067_0d5aa642-d431-4cf4-b3d4-c967283f6c7b 57337-067 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part333E Rejoice International BENZETHONIUM CHLORIDE .3 g/1 N 20181231 57337-068_f9cfa019-3cb1-4683-afc3-3be94afe2c90 57337-068 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part333E Rejoice International BENZETHONIUM CHLORIDE .3 g/1 N 20181231 57337-069_9c714a4a-89f5-46ed-af9f-a4e4415c324d 57337-069 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Fresh Citrus Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E Rejoice International, Inc. TRICLOSAN 3.3 mg/221mL N 20181231 57337-070_c8185c47-a3ed-40cd-be21-6e59d32802ff 57337-070 HUMAN OTC DRUG Baby XtraCare Oatmeal Dimethicone LOTION TOPICAL 20150216 OTC MONOGRAPH FINAL part347 Rejoice International DIMETHICONE 1.2 g/100g N 20181231 57337-071_fb831962-f6b5-418c-a5b1-5f31a799253d 57337-071 HUMAN OTC DRUG XtraCare Cucumber Melon ethyl alcohol GEL TOPICAL 20150217 OTC MONOGRAPH NOT FINAL part333E Rejoice International ALCOHOL 62 g/100g N 20181231 57337-072_dd9141a0-474d-4fd4-8853-a66fbcb5cc65 57337-072 HUMAN OTC DRUG XtraCare Lavender Chamomile ethyl alcohol GEL TOPICAL 20150217 OTC MONOGRAPH NOT FINAL part333E Rejoice International ALCOHOL 62 g/100g N 20181231 57337-073_74fd3954-8ebc-4235-b0d1-68bfc70d7729 57337-073 HUMAN OTC DRUG XtraCare Sweet Pea Blossom ethyl alcohol GEL TOPICAL 20150217 OTC MONOGRAPH NOT FINAL part333E Rejoice International ALCOHOL 62 g/100g N 20181231 57337-074_a9f02a5e-5735-4dcb-a66d-603247d82186 57337-074 HUMAN OTC DRUG XtraCare Warm Vanilla ethyl alcohol GEL TOPICAL 20150217 OTC MONOGRAPH NOT FINAL part333E Rejoice International ALCOHOL 62 g/100g N 20181231 57337-075_24c2703e-5d37-4c01-a996-1cbcff56f911 57337-075 HUMAN OTC DRUG Petroleum Jelly white petrolatum CREAM TOPICAL 20150615 OTC MONOGRAPH FINAL part347 Rejoice International Inc. PETROLATUM 99 g/100g N 20181231 57337-076_2ec9d04a-27d4-44b4-ae93-0d40a63c5d38 57337-076 HUMAN OTC DRUG Baby Petroleum Jelly white petrolatum CREAM TOPICAL 20150615 OTC MONOGRAPH FINAL part347 Rejoice International Inc. PETROLATUM 99 g/100g N 20181231 57337-077_001d4a09-fd46-435d-9292-be07a5156c95 57337-077 HUMAN OTC DRUG Petroleum Jelly white petrolatum CREAM TOPICAL 20150615 OTC MONOGRAPH FINAL part347 Rejoice International Inc. PETROLATUM 99 g/100g N 20181231 57337-078_2a086439-f8b1-460f-a04e-8dc945869562 57337-078 HUMAN OTC DRUG Medicated Foot Powder menthol POWDER TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part348 Rejoice International Inc. MENTHOL 1 g/100g N 20181231 57337-079_3d71636b-8c72-44e2-be57-bb49db4874ae 57337-079 HUMAN OTC DRUG Medicated Body Powder menthol POWDER TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part348 Rejoice International Inc. MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g N 20181231 57337-080_3b4b263a-0a06-34a8-e054-00144ff88e88 57337-080 HUMAN OTC DRUG Acne wash facial cleanser pink grapefruit Salicylic Acid LIQUID TOPICAL 20160801 OTC MONOGRAPH FINAL part333D Rejoice International Corp SALICYLIC ACID 2 g/200mL N 20181231 57337-081_3b51edc2-8f82-33e0-e054-00144ff88e88 57337-081 HUMAN OTC DRUG Acne wash facial cleanser Tea tree oil Salicylic Acid LIQUID TOPICAL 20160801 OTC MONOGRAPH FINAL part333D Rejoice International Corp. SALICYLIC ACID 2 g/200mL N 20181231 57337-082_4e042f5b-3f0d-1830-e054-00144ff88e88 57337-082 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333E Rejoice International Corp. ALCOHOL 62 mL/100mL N 20181231 57337-083_4e04fa70-c25e-4499-e054-00144ff8d46c 57337-083 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333E Rejoice International Corp. ALCOHOL 62 mL/100mL N 20181231 57337-084_4e0655b9-eb3f-1411-e054-00144ff8d46c 57337-084 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333E Rejoice International Corp. ALCOHOL 62 mL/100mL N 20181231 57337-085_4e13511b-fba1-2523-e054-00144ff88e88 57337-085 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20170421 OTC MONOGRAPH NOT FINAL part333E Rejoice International Corp. ALCOHOL 70 mL/100mL N 20181231 57337-086_4e13df0d-52e8-35a7-e054-00144ff88e88 57337-086 HUMAN OTC DRUG Triclosan Free Antibacterial Antibacterial Chloroxylenol LIQUID TOPICAL 20170425 UNAPPROVED DRUG OTHER Rejoice International Corp. CHLOROXYLENOL .3 g/100mL N 20181231 57337-087_515ea2bf-1de8-08e5-e054-00144ff8d46c 57337-087 HUMAN OTC DRUG Triclosan Free Antibacterial 7.5 oz original Antibacterial Chloroxylenol LIQUID TOPICAL 20170606 UNAPPROVED DRUG OTHER Rejoice International Corp. CHLOROXYLENOL .3 g/100mL N 20181231 57337-088_5160c9e0-cae6-66e2-e054-00144ff88e88 57337-088 HUMAN OTC DRUG Triclosan Free Antibacterial 7.5 oz (Ocean) Antibacterial Chloroxylenol LIQUID TOPICAL 20170606 UNAPPROVED DRUG OTHER Rejoice International Corp. CHLOROXYLENOL .3 g/100mL N 20181231 57337-089_5160fd06-b990-6ffe-e054-00144ff8d46c 57337-089 HUMAN OTC DRUG Triclosan Free Antibacterial 7.5 oz (Strawberry Pomegranate) Antibacterial Chloroxylenol LIQUID TOPICAL 20170606 UNAPPROVED DRUG OTHER Rejoice International Corp. CHLOROXYLENOL .3 g/100mL N 20181231 57337-090_5160be3d-d430-6577-e054-00144ff8d46c 57337-090 HUMAN OTC DRUG Triclosan Free Antibacterial 7.5 oz (Fresh Citrus) Antibacterial Chloroxylenol LIQUID TOPICAL 20170606 UNAPPROVED DRUG OTHER Rejoice International Corp. CHLOROXYLENOL .3 g/100mL N 20181231 57337-091_526cd1c3-2052-6f88-e054-00144ff8d46c 57337-091 HUMAN OTC DRUG Antiperspirant Dry 2 oz Men Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20170501 OTC MONOGRAPH FINAL part350 Rejoice International Inc ALUMINUM CHLOROHYDRATE 23 g/100g N 20181231 57337-092_527913be-c6bb-58fb-e054-00144ff8d46c 57337-092 HUMAN OTC DRUG Antiperspirant Dry 2 oz Lady Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20170501 OTC MONOGRAPH FINAL part350 Rejoice International Inc. ALUMINUM CHLOROHYDRATE 23 g/100g N 20181231 57337-093_5b217c03-eafd-3124-e053-2a91aa0a4824 57337-093 HUMAN OTC DRUG Instant Hand Sanitizer 2oz Bonus pack Ethyl Alcohol LIQUID TOPICAL 20171009 OTC MONOGRAPH NOT FINAL part333E Rejoice International Inc. ALCOHOL 70 mL/100mL N 20181231 57344-001_00347e67-180f-4c09-9fd7-98267ef3ec1d 57344-001 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ACETAMINOPHEN 325 mg/1 N 20181231 57344-003_ea5b34f0-4ad2-404f-a2ec-88c7bc17fbf8 57344-003 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 57344-004_f5c97070-c7eb-43d7-888e-9864af4fcfb5 57344-004 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 57344-018_aefa6f29-c36c-4db6-bfb7-a2df5ab3a47a 57344-018 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, COATED ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ASPIRIN 325 mg/1 N 20181231 57344-019_b70eecaa-44d5-4b55-9247-c6f33b6b5e74 57344-019 HUMAN OTC DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20121215 OTC MONOGRAPH FINAL part338 AAA Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 57344-020_ebb60cf2-3eee-49ec-b08a-220e43f1f486 57344-020 HUMAN OTC DRUG Caffeine CAFFEINE TABLET ORAL 20121215 OTC MONOGRAPH FINAL part340 AAA Pharmaceutical, Inc. CAFFEINE 200 mg/1 N 20181231 57344-028_fb728dad-2054-4f60-85a9-4b49ecf081ef 57344-028 HUMAN OTC DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20121215 OTC MONOGRAPH FINAL part338 AAA Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 57344-035_0f500946-18c8-4139-8f09-3bf58fd85c95 57344-035 HUMAN OTC DRUG Pseudoephedrine Hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 57344-080_10c8873c-bcbd-4fe5-8358-775eb9abdb8b 57344-080 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ASPIRIN 81 mg/1 N 20181231 57344-081_a6f227fc-1807-4d88-a7b0-a0fa4e9d9f5d 57344-081 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ASPIRIN 325 mg/1 N 20181231 57344-090_d9529bb8-12e2-4115-8d08-35076244fa64 57344-090 HUMAN OTC DRUG Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 57344-091_68084330-aaed-4ea9-a002-0a34b7312e5e 57344-091 HUMAN OTC DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20121215 OTC MONOGRAPH FINAL part338 AAA Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 57344-092_c139cf5d-3428-4271-ada1-f20b434dcbcb 57344-092 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 57344-095_052c52a3-1bc5-499c-8cc8-b28c1547bd7d 57344-095 HUMAN OTC DRUG Acetaminophen PM Acetaminophen and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20121213 OTC MONOGRAPH FINAL part338 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 57344-098_158799bd-d45c-4779-b2d2-2b68ffaba23d 57344-098 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 57344-101_8318049c-8927-4544-b050-499fb34d8956 57344-101 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hydrochloride ACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 12.5 mg/1; mg/1 N 20181231 57344-105_fc3ea080-77cb-4da8-a916-afc70bfc738f 57344-105 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, CHEWABLE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ASPIRIN 81 mg/1 N 20181231 57344-109_60e8efbe-7e39-4698-9bdf-50b6487bf523 57344-109 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20121204 ANDA ANDA079129 AAA Pharmaceutical, Inc. IBUPROFEN 200 mg/1 E 20171231 57344-110_55f21d7c-3c42-4044-965a-aaadefcc4ba1 57344-110 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20121204 ANDA ANDA079129 AAA Pharmaceutical, Inc. IBUPROFEN 200 mg/1 E 20171231 57344-111_a13e3b28-9a54-462e-bbe4-c7a6452c5b5b 57344-111 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20121204 ANDA ANDA091355 AAA Pharmaceutical, Inc. IBUPROFEN 200 mg/1 E 20171231 57344-112_19d120e6-ff7a-4e2e-bd25-e8c89c99beb7 57344-112 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20121204 ANDA ANDA091355 AAA Pharmaceutical, Inc. IBUPROFEN 200 mg/1 E 20171231 57344-113_82d0cc68-3a24-4f86-bdb8-00f3cf364375 57344-113 HUMAN OTC DRUG Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 57344-119_8cefa83b-202c-41d0-9965-ed615ffce5eb 57344-119 HUMAN OTC DRUG Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 57344-120_e3f2dfa7-3762-40ba-9ecd-7e6aeb3c1562 57344-120 HUMAN OTC DRUG Acetaminophen, Phenylephrine Hydrochloride ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 57344-123_d7402b15-fa6c-4197-98e2-b4ecad1b64c4 57344-123 HUMAN OTC DRUG Acetaminophen, Phenylephrine Hydrochloride ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 57344-124_61c8f3f8-37b8-46c2-a90a-d97f2b057ca6 57344-124 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 57344-125_69471d5f-7f6e-4fd9-ae53-f4ce2866d101 57344-125 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 57344-126_2ca2f908-51b2-47d9-a0b7-4da58ac6ab33 57344-126 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hyhrochloride, Phenylephrine Hydrochloride ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 57344-127_638ae864-5a49-46b4-9a41-aa926e2a0305 57344-127 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 57344-128_d28e5412-c97c-4ed8-bb1c-47f44e8f0547 57344-128 HUMAN OTC DRUG Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 57344-131_6e19e526-1f1c-41ba-90ff-bbaff1e3ecf8 57344-131 HUMAN OTC DRUG Phenylephrine Hydrochloride PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 57344-133_3b1386d4-3060-44dd-94f2-7e95a7d126ed 57344-133 HUMAN OTC DRUG Chlorpheniramine Maleate, Phenylephrine Hydrochloride CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 57344-134_ad636072-c579-423d-a291-6574e43f1187 57344-134 HUMAN OTC DRUG Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 57344-136_8ffe8753-299d-46e2-a967-d7d1512bba2a 57344-136 HUMAN OTC DRUG Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 57344-138_e63493e7-61f1-4e10-86c3-25e26e18b807 57344-138 HUMAN OTC DRUG Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 57344-139_91cd3662-4fd2-479f-ad1d-618b81f6f839 57344-139 HUMAN OTC DRUG Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 57344-144_e4a322f3-1cce-4c34-ac8a-21b218a879ff 57344-144 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20121215 ANDA ANDA079096 AAA Pharmaceutical, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 57344-145_5d765fcc-bfa7-4791-b533-b28f73b01f40 57344-145 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20121215 ANDA ANDA079096 AAA Pharmaceutical, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 57344-146_c18169d7-dbd3-4c01-8296-e060259c32e6 57344-146 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ASPIRIN 81 mg/1 N 20181231 57344-147_d10f835d-c53b-4083-960a-fdaddb965db0 57344-147 HUMAN OTC DRUG Day and Night Cold Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. N 20181231 57344-149_f0b42e7b-eab2-4048-b894-706ba48f4330 57344-149 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Nighttime Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride KIT 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. N 20181231 57344-150_fff544f0-d591-4846-b1a4-e8bb980802a6 57344-150 HUMAN OTC DRUG Cold Multi-Symptom Daytime Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride KIT 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. N 20181231 57344-152_ba405a82-f20f-4160-9b79-b4bf16d13f91 57344-152 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, CHEWABLE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ASPIRIN 81 mg/1 N 20181231 57344-154_8574bbc6-eb08-45d1-b37c-66bc8bd2dd9e 57344-154 HUMAN OTC DRUG Acetaminophen, Phenylephrine Hydrochloride ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 57344-155_37b30e79-02e8-41ec-a0b2-c1d4a9173e1b 57344-155 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 57344-156_faca8b2e-d481-4bbd-b464-85cc773bc298 57344-156 HUMAN OTC DRUG Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 57344-157_1f1f3f18-e27e-4d3e-95e1-0aca99bda81d 57344-157 HUMAN OTC DRUG Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 57344-158_462fdf0c-9490-4fdf-9c9c-c31ecf0d4a5e 57344-158 HUMAN OTC DRUG Chlorpheniramine Maleate, Phenylephrine Hydrochloride CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121222 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 57344-159_315efefa-c8e5-47c5-9594-cc749c155a8f 57344-159 HUMAN OTC DRUG Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 57344-160_1b6854b7-927b-452b-8eab-66d660db5ba3 57344-160 HUMAN OTC DRUG Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 57344-161_235bb3fd-b4e3-44c6-82b5-230ca26e610b 57344-161 HUMAN OTC DRUG Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 57344-162_b79b6936-d18b-4604-a155-6a16eb23dd61 57344-162 HUMAN OTC DRUG Cold Head Congestion Daytime / Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride KIT 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. N 20181231 57344-163_2e4cad0f-e170-45ef-bb17-684eb1e2cbcd 57344-163 HUMAN OTC DRUG Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 57344-170_f1ba6a9d-ddb6-441e-b44e-9c55a029cddd 57344-170 HUMAN OTC DRUG Acetaminophen Rapid Release Acetaminophen TABLET, COATED ORAL 20140326 OTC MONOGRAPH NOT FINAL part343 AAA Pharmaceutical, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 57344-171_46830d77-d9fb-4082-946b-9f0392eadae5 57344-171 HUMAN OTC DRUG Acetaminophen PM Rapid Release Acetaminophen and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20140326 OTC MONOGRAPH FINAL part341 AAA Pharmaceutical, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 57349-313_ccbec830-bec5-4669-b57a-eb635c347c2c 57349-313 HUMAN OTC DRUG EyS Eye Wash Water SOLUTION OPHTHALMIC 20130301 OTC MONOGRAPH FINAL part349 Eyes-Plus LLC WATER 14.85 mL/15mL E 20171231 57349-913_6f847a9c-7948-4d70-ada9-56160962fb6f 57349-913 HUMAN OTC DRUG EyS Eye Wash Water SOLUTION OPHTHALMIC 20130301 OTC MONOGRAPH FINAL part349 Eyes-Plus LLC WATER .98 mL/mL N 20181231 57353-103_64312c00-01cd-4e17-863f-3468ef006eec 57353-103 HUMAN OTC DRUG LUSTER NOW INSTANT WHITENING SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 DENTOVATIONS INC SODIUM FLUORIDE .24 g/100g E 20171231 57353-105_ba49539d-1fb1-4fe3-84d3-89725c650f46 57353-105 HUMAN OTC DRUG ELECTRIFYING BLUE POLISH SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20150122 OTC MONOGRAPH FINAL part355 DENTOVATIONS INC SODIUM FLUORIDE .24 g/100g E 20171231 57353-106_77cb0607-88a1-4157-9af3-dff749c04ba1 57353-106 HUMAN OTC DRUG LUSTER POWER WHITE DEEP STAIN ERASER SODIUM MONOFLUOROPHOSPHATE GEL, DENTIFRICE ORAL 20121201 OTC MONOGRAPH FINAL part355 DENTOVATIONS INC SODIUM MONOFLUOROPHOSPHATE .88 g/100g E 20171231 57356-207_f8c07676-35ec-4e55-bbad-e892ad979e65 57356-207 HUMAN OTC DRUG RX200 Foaming Instant Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20091214 OTC MONOGRAPH NOT FINAL part333A The Bullen Companies, Inc. BENZALKONIUM CHLORIDE 4.918 g/100mL E 20171231 57362-464_141b8704-9619-6add-e054-00144ff88e88 57362-464 HUMAN OTC DRUG ZylastXP Antiseptic benzethonium chloride LOTION TOPICAL 20150424 OTC MONOGRAPH NOT FINAL part333E Innovative BioDefense BENZETHONIUM CHLORIDE 192.3 mg/1000mg E 20171231 57362-464_17a5768b-5f4e-507d-e054-00144ff8d46c 57362-464 HUMAN OTC DRUG ZylastXP Antiseptic Benzethonium Chloride LOTION TOPICAL 20150424 OTC MONOGRAPH NOT FINAL part333E Innovative BioDefense BENZETHONIUM CHLORIDE 192.3 mg/1000mg E 20171231 57362-464_23e46dbd-61ab-0bd1-e054-00144ff88e88 57362-464 HUMAN OTC DRUG ZylastXP Antiseptic Benzethonium Chloride LOTION TOPICAL 20151106 OTC MONOGRAPH NOT FINAL part333E Innovative BioDefense BENZETHONIUM CHLORIDE 192.3 mg/1000mg E 20171231 57362-464_2ae1e795-11d1-2996-e054-00144ff8d46c 57362-464 HUMAN OTC DRUG ZylastXP Antiseptic Benzethonium Chloride LOTION TOPICAL 20150419 OTC MONOGRAPH NOT FINAL part333E Innovative BioDefense BENZETHONIUM CHLORIDE 192.3 mg/1000mg E 20171231 57362-465_178190dc-7c69-6485-e054-00144ff8d46c 57362-465 HUMAN OTC DRUG Zylast Antiseptic Ethyl Alcohol GEL TOPICAL 20150424 OTC MONOGRAPH NOT FINAL part333E Innovative BioDefense ALCOHOL 44.9 mL/59.1mL E 20171231 57362-465_17a70b04-3e62-27ae-e054-00144ff8d46c 57362-465 HUMAN OTC DRUG Zylast Antiseptic Ethyl Alcohol GEL TOPICAL 20150424 OTC MONOGRAPH NOT FINAL part333E Innovative BioDefense ALCOHOL 44.9 mL/59.1mL E 20171231 57366-0001_4a6372b0-c625-4a7f-a7c7-16752bba9a4e 57366-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19951220 UNAPPROVED MEDICAL GAS MedQuest, Inc. OXYGEN 99 L/100L E 20171231 57367-001_4551f41d-c0e3-485e-950b-9014633e75e7 57367-001 HUMAN OTC DRUG GIGI ANESTHETIC NUMBING LIDOCAINE AEROSOL TOPICAL 19971027 OTC MONOGRAPH FINAL part348 220 LABORATORIES INC LIDOCAINE 40 mg/g E 20171231 57367-007_f82e9fcf-7441-4beb-8f64-79b6b8ee5061 57367-007 HUMAN OTC DRUG NICK RELIEF ALUMINUM SULFATE STICK TOPICAL 19971127 OTC MONOGRAPH FINAL part347 220 LABORATORIES INC ALUMINUM SULFATE 46 mg/mL E 20171231 57367-008_2f75fe11-48b7-4221-a4ee-5195ca7832d8 57367-008 HUMAN OTC DRUG Anti-Perspirant Deodorant ALUMINUM CATION STICK TOPICAL 20100525 OTC MONOGRAPH FINAL part350 220 Laboratories Inc ALUMINUM CHLOROHYDRATE 52 mg/g E 20171231 57367-027_de535765-6fa3-4715-9dcc-037f6dc80577 57367-027 HUMAN OTC DRUG DAY HYDRATOR SPF-15 OCTINOXATE and OCTISALATE and OXYBENZONE LOTION TOPICAL 20060201 OTC MONOGRAPH NOT FINAL part352 220 Laboratories Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 30 mg/g; mg/g; mg/g E 20171231 57367-029_b0602558-795b-4916-b143-74d0e6e6a84c 57367-029 HUMAN OTC DRUG SUNSCREEN WATER RESISTANT HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE AEROSOL, SPRAY TOPICAL 20100510 OTC MONOGRAPH NOT FINAL part352 220 Laboratories Inc HOMOSALATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 150; 50; 50; 30; 20 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 57367-033_3cc1078d-c61a-4b3c-877f-e0cbb6e7b9e7 57367-033 HUMAN OTC DRUG THERABREATH TOOTHPASTE SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20100303 OTC MONOGRAPH FINAL part355 220 LABORATORIES INC SODIUM FLUORIDE 24 mg/10g E 20171231 57373-108_6cb7a46a-84aa-43fb-8da2-c33ddf573f0b 57373-108 HUMAN OTC DRUG Monkey Holding Peach Brand External Analgesic Balm Camphor,Menthol,Methyl Salicylate OINTMENT TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part348 P.S.W. INC. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 22; 16; 3 g/100g; g/100g; g/100g E 20171231 57424-141_3e218672-c476-486d-8dfa-fe60d4a2746e 57424-141 HUMAN OTC DRUG Hi-Tech Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Economical Janitorial Supplies CHLOROXYLENOL 3.75 mg/mL E 20171231 57439-000_be8d7d5b-eaf5-42b7-94a5-18b4bb43858f 57439-000 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20180101 UNAPPROVED MEDICAL GAS Rotech Healthcare Inc OXYGEN 99 L/100L N 20191231 57439-001_be8d7d5b-eaf5-42b7-94a5-18b4bb43858f 57439-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20180101 UNAPPROVED MEDICAL GAS Rotech Healthcare Inc OXYGEN 99 L/100L N 20191231 57451-5065_65566771-7db3-4f49-ad00-8b561eade5e4 57451-5065 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20100625 ANDA ANDA090283 Ipca Laboratories Limited FAMOTIDINE 10 mg/1 E 20171231 57451-5066_65566771-7db3-4f49-ad00-8b561eade5e4 57451-5066 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20100723 ANDA ANDA090283 Ipca Laboratories Limited FAMOTIDINE 20 mg/1 E 20171231 57451-5067_6f2ce1a0-e50d-4feb-9b52-e70fca156c7e 57451-5067 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Ipca Laboratories Limited CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 57465-100_eb21b7c5-86d1-4046-a5fe-3f06ae050221 57465-100 HUMAN OTC DRUG Estomarol ALUMINUM HYDROXIDE, BISMUTH SUBCARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, SODIUM BICARBONATE POWDER ORAL 20110511 OTC MONOGRAPH FINAL part331 Laboratorios Imperiales, S.A. de C.V. ALUMINUM HYDROXIDE; BISMUTH SUBCARBONATE; CALCIUM CARBONATE; MAGNESIUM CARBONATE; SODIUM BICARBONATE .18; .21; .25; .59; 2.27 g/3.5g; g/3.5g; g/3.5g; g/3.5g; g/3.5g E 20171231 57469-064_318d3a82-65c8-1cf4-e054-00144ff8d46c 57469-064 HUMAN OTC DRUG Emoji Antibacterial Hand Wipes BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20160428 OTC MONOGRAPH NOT FINAL part333E Bolero Home Decor, Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 57469-065_5b71af41-bbdd-dedb-e053-2a91aa0ad895 57469-065 HUMAN OTC DRUG Raw Sugar Hand Sanitizer- Peppermint and Sea Salt. Alcohol GEL TOPICAL 20160923 OTC MONOGRAPH NOT FINAL part333A Bolero Home Decor, Inc. ALCOHOL .62 mL/mL N 20181231 57469-067_5b71af41-bbe9-dedb-e053-2a91aa0ad895 57469-067 HUMAN OTC DRUG Raw Sugar Hand Sanitizer- Coconut and Lemon Verbena Alcohol GEL TOPICAL 20161004 OTC MONOGRAPH NOT FINAL part333A Bolero Home Decor, Inc. ALCOHOL .62 mL/mL N 20181231 57471-3061_5d48ea4c-f49e-4ce3-b126-589bece4170a 57471-3061 HUMAN OTC DRUG Bryonia Alba Bryonia Alba PELLET ORAL 19880701 UNAPPROVED HOMEOPATHIC Celletech Ltd. BRYONIA ALBA ROOT 30 [hp_C]/1 E 20171231 57472-001_2f95294f-4a96-48c1-b62a-3abf4e6be739 57472-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS AIRGAS NOR PAC INC OXYGEN 995 mL/L E 20171231 57472-002_5bf03867-b1da-4bce-95fa-c63c871a255c 57472-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS AIRGAS NOR PAC INC NITROGEN 995 mL/L E 20171231 57472-003_7881d7c9-ebea-4092-8b21-38d2b823ad17 57472-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS AIRGAS NOR PAC INC NITROUS OXIDE 992 mL/L E 20171231 57472-004_6fdd4b14-a689-45c7-9c68-848483abc227 57472-004 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS AIRGAS NOR PAC INC CARBON DIOXIDE 992 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 57472-005_8852cad5-9e11-4bf0-8986-037792f57539 57472-005 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mix Carbon Dioxide Oxygen Mix GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS AIRGAS-NORPAC INC. CARBON DIOXIDE; OXYGEN 200; 800 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 57472-006_903f6c44-2f78-42ad-a79f-230bb3b578b6 57472-006 HUMAN PRESCRIPTION DRUG AIR AIR GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS AIRGAS-NORPAC INC. AIR 1000 mL/L E 20171231 57472-007_7a83fc9c-ae0c-430a-bdf6-443d1370df88 57472-007 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19830101 UNAPPROVED MEDICAL GAS AIRGAS-NORPAC INC. HELIUM 995 mL/L E 20171231 57479-101_65756674-3eae-45a7-bc61-d0694015aeb3 57479-101 HUMAN OTC DRUG POISON OAK HYDROCORTISONE, PHENOL GEL TOPICAL 20121129 OTC MONOGRAPH NOT FINAL part348 DeMartini Spring Hill Pharmacy, Inc. HYDROCORTISONE; PHENOL 1; .5 g/100g; g/100g E 20171231 57483-001_49517d2c-a3f5-4d18-bccf-9582cd656559 57483-001 HUMAN OTC DRUG Apeaz Ultra camphor, menthol, methyl salicylate cream CREAM TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part348 Innovus Pharmaceuticals, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g E 20171231 57483-003_8ed5ea44-59d6-4851-8fa6-e8babc69206a 57483-003 HUMAN OTC DRUG EJECTDELAY Gel Benzocaine 7.5% GEL TOPICAL 20130715 OTC MONOGRAPH FINAL part333B Innovus Pharmaceuticals, Inc. BENZOCAINE 7.5 g/100g N 20181231 57483-003_d4d19065-51a3-4c21-a615-060a82546328 57483-003 HUMAN OTC DRUG EJECTDELAY Gel Benzocaine 7.5% GEL TOPICAL 20130715 OTC MONOGRAPH FINAL part333B Innovus Pharmaceuticals, Inc. BENZOCAINE 7.5 g/100g N 20181231 57483-005_c72952e6-bfe5-485b-8c62-787ff4179b62 57483-005 HUMAN OTC DRUG fluticasone propionate fluticasone propionate SPRAY, METERED NASAL 20170922 ANDA ANDA207957 Innovus Pharmaceuticals Inc. FLUTICASONE PROPIONATE 50 ug/1 N 20181231 57483-101_e846c678-e964-4414-8c96-c9458e1b032c 57483-101 HUMAN OTC DRUG Apeaz Ultra camphor (synthetic), menthol, and methyl salicylate cream CREAM TOPICAL 20180205 OTC MONOGRAPH NOT FINAL part348 Innovus Pharmaceuticals, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 7.5; 10 mg/g; mg/g; mg/g N 20191231 57483-108_73617bf2-7f79-4e5e-81b4-8c5ba6c05b8c 57483-108 HUMAN OTC DRUG Xyralid Lidocaine 5% CREAM TOPICAL 20170706 OTC MONOGRAPH FINAL part346 Innovus Pharmaceuticals, Inc. LIDOCAINE 5 g/100g N 20181231 57501-865_10d2838b-1bb2-47ef-a726-1ae087ce63c8 57501-865 HUMAN OTC DRUG Mata Piojos A Pediculicide Low Foaming Pyrethrum Extract, Piperonyl Butoxide SHAMPOO TOPICAL 20100423 OTC MONOGRAPH FINAL part358G Apex International Mfg PYRETHRUM EXTRACT; PIPERONYL BUTOXIDE .12; 2.4 g/60g; g/60g E 20171231 57501-953_5533c604-c92e-4002-87ce-c163df9a4cb1 57501-953 HUMAN OTC DRUG Oil Free Acne Scrub Salicylic Acid Acne Treatment Salicylic Acid LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333D Apex International Mfg SALICYLIC ACID 2.5 g/125g E 20171231 57511-0101_64194895-a337-a062-e053-2a91aa0a9ad4 57511-0101 HUMAN OTC DRUG FluoriMax 5000 1.1% Sodium Fluoride Toothpaste PASTE, DENTIFRICE TOPICAL 20150201 OTC MONOGRAPH FINAL part355 Elevate Oral Care SODIUM FLUORIDE 1.1 mg/mg N 20191231 57511-0102_64191ca5-c948-2de5-e053-2a91aa0a7122 57511-0102 HUMAN OTC DRUG FluoriMax 5000 Sensitive 1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste PASTE, DENTIFRICE TOPICAL 20170801 UNAPPROVED DRUG OTHER Elevate Oral Care POTASSIUM NITRATE; SODIUM FLUORIDE 1.4175; .070875 g/28.35g; g/28.35g N 20191231 57511-0119_6418e3de-6c77-4fb3-e053-2a91aa0a6274 57511-0119 HUMAN OTC DRUG Just Right 5000 1.1% Sodium Fluoride Toothpaste GEL, DENTIFRICE TOPICAL 20180101 OTC MONOGRAPH FINAL part355 Elevate Oral Care SODIUM FLUORIDE 1.1 mg/mg N 20191231 57511-0120_64189597-dbf7-8142-e053-2a91aa0a63b4 57511-0120 HUMAN OTC DRUG Just Right 5000 1.1% Sodium Fluoride Toothpaste GEL, DENTIFRICE TOPICAL 20180101 OTC MONOGRAPH FINAL part355 Elevate Oral Care SODIUM FLUORIDE 1.1 mg/mg N 20191231 57511-0124_64190477-d1a5-bf97-e053-2991aa0af84f 57511-0124 HUMAN OTC DRUG Just Right 0.243% Sodium Fluoride Toothpaste GEL, DENTIFRICE TOPICAL 20130507 OTC MONOGRAPH FINAL part355 Elevate Oral Care SODIUM FLUORIDE .243 mg/mg N 20191231 57511-0201_6418350c-b5b4-badb-e053-2991aa0a4db6 57511-0201 HUMAN OTC DRUG Stance 0.63% Stannous Fluoride Rinse Concentrate RINSE TOPICAL 20160825 OTC MONOGRAPH FINAL part355 Elevate Oral Care STANNOUS FLUORIDE .63 mg/mg N 20191231 57511-0202_64185fd7-11ee-0e96-e053-2991aa0a07c3 57511-0202 HUMAN OTC DRUG Stance 0.63% Stannous Fluoride Rinse Concentrate RINSE TOPICAL 20160825 OTC MONOGRAPH FINAL part355 Elevate Oral Care STANNOUS FLUORIDE .63 mg/mg N 20191231 57518-0001_486f486b-206d-423e-8ebd-5ce326647696 57518-0001 HUMAN OTC DRUG Lymph-A-Derm Calendula officinalis, Spilanthes oleracea, Petroleum, Colchicum autumnale, Conium maculatum, Podophyllum peltatum, Antimonium sulphuratum aureum, Mercurius iodatus flavus CREAM TOPICAL 20140808 UNAPPROVED HOMEOPATHIC Biomed International CALENDULA OFFICINALIS FLOWERING TOP; ACMELLA OLERACEA FLOWERING TOP; PETROLATUM; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; PODOPHYLLUM; ANTIMONY PENTASULFIDE; MERCUROUS IODIDE 1; 1; 2; 3; 3; 3; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0010_20d0bbe4-1d91-471b-b24c-dd8e635d6086 57520-0010 HUMAN OTC DRUG Bio Cerato Cerato LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company CERATOSTIGMA WILLMOTTIANUM FLOWER 200 [hp_C]/mL N 20181231 57520-0026_6ed9809a-a0da-4e65-b921-1f61c85949d0 57520-0026 HUMAN OTC DRUG ACNEFORCE Berberis vulgaris, Cimicifuga racemosa, Hydrocotyle asiatica, Lappa major, Belladonna, Calcarea carbonica, Causticum, Eugenia jambosa, LIQUID ORAL 20100128 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SEPIA OFFICINALIS JUICE; PALLADIUM; CENTELLA ASIATICA; BLACK COHOSH; BERBERIS VULGARIS ROOT BARK; ARCTIUM LAPPA ROOT; VIOLA TRICOLOR; CAUSTICUM; POTASSIUM BROMIDE; EUGENIA JAMBOS 12; 12; 12; 12; 3; 3; 3; 3; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0031_966f2217-ccbc-4251-b93e-6614b4d88d03 57520-0031 HUMAN OTC DRUG Bio Sweet Chestnut Sweet chestnut. LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Apotheca Company CASTANEA SATIVA FLOWER 200 [hp_C]/mL N 20181231 57520-0052_185d82a9-0b67-4317-b35b-e9b3bb23d21a 57520-0052 HUMAN OTC DRUG Stomach Relief Arsenicum album, Carbo vegetabilis, Nux vomica, Robinia pseudoacacia, LIQUID ORAL 20100127 20190724 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; STRYCHNOS NUX-VOMICA SEED; ROBINIA PSEUDOACACIA BARK 30; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0057_68fee4fb-8689-4707-830c-e492e79496a9 57520-0057 HUMAN OTC DRUG Heal Grief Heal Grief LIQUID ORAL 20100126 UNAPPROVED HOMEOPATHIC Apotheca Company SODIUM CHLORIDE; DELPHINIUM STAPHISAGRIA SEED; STRYCHNOS IGNATII SEED; PHOSPHORIC ACID 12; 12; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0058_d7d85abd-8ff1-4224-be4d-b3cbb30e6521 57520-0058 HUMAN OTC DRUG Energize Avena sativa, Zingiber officinale, Aralia quinquefolia, Phosphoricum acidum, Picricum acidum, Kali phosphoricum LIQUID ORAL 20100125 20181002 UNAPPROVED HOMEOPATHIC Apothica Company AVENA SATIVA FLOWERING TOP; GINGER; AMERICAN GINSENG; PHOSPHORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; TRINITROPHENOL 3; 3; 6; 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0061_04454b6b-ced7-418e-b80b-4e3b281418c5 57520-0061 HUMAN OTC DRUG Bye, Bye Ver Artemisia vulgaris, Filix mas, Tanacetum vulgare, Teucrium marum, Absinthium, Cina, Chenopodium anthelminticum, LIQUID ORAL 20100205 UNAPPROVED HOMEOPATHIC Apotheca Company TANACETUM VULGARE TOP; ARTEMISIA ABSINTHIUM POLLEN; CHENOPODIUM AMBROSIOIDES; MERCURIC CHLORIDE; DRYOPTERIS FILIX-MAS ROOT; TEUCRIUM MARUM; GRAPHITE; ARTEMISIA VULGARIS ROOT; TURPENTINE; SPIGELIA ANTHELMIA; ARTEMISIA CINA FLOWER; ASCARIS LUMBRICOIDES; ECHINOCOCCUS GRANULOSUS; ENTEROBIUS VERMICULARIS; TAENIA SAGINATA; TAENIA SOLIUM 3; 4; 6; 6; 3; 3; 12; 1; 6; 12; 4; 12; 12; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0069_5275983b-97db-46af-9a3c-dd399b141d48 57520-0069 HUMAN OTC DRUG Contact Allergy Rhus toxicodendron, Rhus diversiloba, Rhus venenate, Uritica dioica, Anacardium orientale, Graphites, LIQUID ORAL 20100209 UNAPPROVED HOMEOPATHIC Apotheca Company TOXICODENDRON PUBESCENS LEAF; TOXICODENDRON DIVERSILOBUM LEAF; URTICA DIOICA; SEMECARPUS ANACARDIUM JUICE; XEROPHYLLUM ASPHODELOIDES; GRAPHITE; DAPHNE MEZEREUM BARK; TOXICODENDRON VERNIX LEAFY TWIG 30; 30; 30; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0075_156d70dd-30d1-4058-ac0f-70da7c69c702 57520-0075 HUMAN OTC DRUG CV HP Lycopus virginicus, Valeriana officinalis, Aurum metallicum, Cactus grandiflorus, Cuprum aceticum, Digitralis purpurea, Natrum muriaticum, Phosphorus, Pulsatilla, LIQUID ORAL 20100210 20181022 UNAPPROVED HOMEOPATHIC Apotheca Company VALERIAN; GOLD; SELENICEREUS GRANDIFLORUS STEM; DIGITALIS; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; CUPRIC ACETATE; LYCOPUS VIRGINICUS 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 57520-0099_3715c74f-6dab-456a-bd34-efdd7c629615 57520-0099 HUMAN OTC DRUG FNG II Echinacea angustifolia, Hydrastis canadensis, Lomatium, Nasturtium aquaticum, Tabebuia impetiginosa, Iodium, Adrenalinum, Argentum metallicum, Thymus, Thyroidinum, Phosphoricum acidum, Candida albicans, Lycopodium clavatum, Pulsatilla, Sepia LIQUID ORAL 20100217 UNAPPROVED HOMEOPATHIC Apotheca Company ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; TABEBUIA IMPETIGINOSA BARK; IODINE; EPINEPHRINE; SILVER; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; PHOSPHORIC ACID; CANDIDA ALBICANS; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; RORIPPA NASTURTIUM-AQUATICUM 3; 3; 3; 3; 6; 8; 8; 8; 8; 12; 30; 30; 30; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0133_c0e34435-7ef4-409a-897a-076f81d44240 57520-0133 HUMAN OTC DRUG Sinus Clear Hepar sulphuris calcareum, Kali bichromicum, Pulsatilla, Silicea, CAPSULE ORAL 20101108 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM SULFIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0134_67f2d48b-e402-4b46-83b0-9b17574f7478 57520-0134 HUMAN OTC DRUG Sinus Clear Hepar sulphuris calcareum, Kali bichromicum, Pulsatilla, Silicea, CAPSULE ORAL 20101104 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM SULFIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0138_d92c3601-1c0d-44d8-ac1e-0bac54c5a579 57520-0138 HUMAN OTC DRUG Optimal HCG Fucus vesiculosus, Cyanocobalamin, Glandula suprarenalis suis, Hepar suis, L-carnitine, Ornithine, Antimonium crudum, LIQUID ORAL 20100819 UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS; CYANOCOBALAMIN; SUS SCROFA ADRENAL GLAND; PORK LIVER; LEVOCARNITINE; ORNITHINE; ANTIMONY TRISULFIDE; HUMAN CHORIONIC GONADOTROPIN; SUS SCROFA THYROID; SODIUM SULFATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PANCRELIPASE; SUS SCROFA HYPOTHALAMUS 2; 6; 6; 6; 30; 30; 8; 60; 8; 10; 12; 12; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0140_417028ec-c6d9-4b96-a1d1-228c99671afc 57520-0140 HUMAN OTC DRUG Total Body Detox Citrus limonum, Taraxacum officinale, Uva-ursi, Berberis vulgaris, Capsicum annuum, Galium aparine, Lobelia inflata, Nux vomica, Schisandra, Tylophora, Brain, Cor suis, Glandula suprarenalis suis, LIQUID ORAL 20100311 UNAPPROVED HOMEOPATHIC Apotheca Company LEMON JUICE; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS FRUIT; CAPSICUM; GALIUM APARINE; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; SCHISANDRA CHINENSIS FRUIT; SUS SCROFA ADRENAL GLAND; PORK INTESTINE; PORK LIVER; CALCIUM SULFIDE; PORK KIDNEY; LACTIC ACID, DL-; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SUS SCROFA SPLEEN; THYROID; PORK BRAIN; SUS SCROFA LUNG; SUS SCROFA LYMPH; PORK HEART; TYLOPHORA INDICA ROOT 1; 2; 2; 3; 3; 3; 3; 3; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0141_cc043629-0e88-4df1-b0d5-365649b43ace 57520-0141 HUMAN OTC DRUG Thyro T3 Rescue Spongia tosta, Iodium Fucus vesiculosus, Belladonna, Adenosine triphosphate, Parathyroid, LIQUID ORAL 20100312 UNAPPROVED HOMEOPATHIC Apotheca Company SPONGIA OFFICINALIS SKELETON, ROASTED; IODINE; FUCUS VESICULOSUS; ATROPA BELLADONNA; ADENOSINE TRIPHOSPHATE; THYROID; SUS SCROFA HYPOTHALAMUS; PORK KIDNEY; SUS SCROFA THYMUS; LEVOTHYROXINE; SUS SCROFA PARATHYROID GLAND; SELENIUM; LIOTHYRONINE; BEEF LIVER; SUS SCROFA PITUITARY GLAND 6; 1; 1; 200; 3; 1; 30; 30; 30; 3; 8; 8; 3; 30; 30 [hp_X]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0143_02d86a85-bd06-4f30-b0f4-76b3f68f5af2 57520-0143 HUMAN OTC DRUG Endopure Testos-Male DNA, RNA, Cortisol, Glandula suprarenalis, Hypothalamus, Pitrutary, Prostate, Testosterone, LIQUID ORAL 20100402 UNAPPROVED HOMEOPATHIC Apotheca Company HERRING SPERM DNA; SACCHAROMYCES CEREVISIAE RNA; HYDROCORTISONE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; TESTOSTERONE; CHELIDONIUM MAJUS; SAW PALMETTO; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA ADRENAL GLAND 6; 6; 6; 6; 6; 6; 12; 12; 12; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0144_93793271-55d2-48b4-a921-83f1759236ce 57520-0144 HUMAN OTC DRUG Neuro Balance Pro Adrenocorticotrophin, Gaba, Glutamic acid, Norepinephrine, Acetylcholine chloride, Adrenalinum SPRAY ORAL 20100407 UNAPPROVED HOMEOPATHIC ApothecaCompany CORTICOTROPIN; .GAMMA.-AMINOBUTYRIC ACID; GLUTAMIC ACID; NOREPINEPHRINE; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; SEROTONIN; THYROID; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; DATURA STRAMONIUM; SEMECARPUS ANACARDIUM JUICE; LEVODOPA 30; 3; 3; 30; 1; 1; 1; 12; 200; 200; 1; 200; 1 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL; [hp_C]/mL; [hp_M]/mL N 20181231 57520-0150_8a841ae0-2af9-450c-89b6-8e747d7f358f 57520-0150 HUMAN OTC DRUG Liver Tonic II Boldo, Carduus marianus, Curcuma, Echinacea angustifolia, Taraxacum officinale, Magnesia phosphorica, Gallbladder, LIQUID ORAL 20100308 UNAPPROVED HOMEOPATHIC Apotheca Company PEUMUS BOLDUS LEAF; SILYBUM MARIANUM SEED; ECHINACEA ANGUSTIFOLIA; TARAXACUM OFFICINALE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SUS SCROFA GALLBLADDER; AMMI VISNAGA FRUIT; ATROPINE SULFATE; CHELIDONIUM MAJUS; TURMERIC; BEEF LIVER; TURMERIC; PODOPHYLLUM PELTATUM ROOT; CULVER'S ROOT 1; 1; 1; 1; 8; 200; 12; 12; 12; 1; 200; 1; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 57520-0154_cccabf04-6888-4c58-98dd-168cbbc0549e 57520-0154 HUMAN OTC DRUG Iodine Plus Capsule Thyroidinum, Thyroxine, Trilodothyronine, CAPSULE ORAL 20100713 UNAPPROVED HOMEOPATHIC Apotheca Company THYROID; LEVOTHYROXINE; LIOTHYRONINE 30; 30; 200 [hp_X]/mg; [hp_X]/mg; [hp_C]/mg N 20181231 57520-0156_88f3e94a-050b-4897-9a32-8d47d19ccf0e 57520-0156 HUMAN OTC DRUG Pre Post Surgery HP Arnica montana, Bellis perennis, Bryonia, Calendula officinalis, Hypericum perforatum, Ledum palustre, Phosphorus, Pyrogenium, Rhus toxicodendron, LIQUID ORAL 20101001 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT 12; 12; 12; 3; 12; 12; 12; 30; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0157_c8b67091-950b-477e-9a6a-268704b521d3 57520-0157 HUMAN OTC DRUG Sore Throat Echinacea purpurea, Plantago major, Baptisia tinctoria SPRAY ORAL 20100625 UNAPPROVED HOMEOPATHIC Apotheca Company ECHINACEA PURPUREA; PLANTAGO MAJOR; BAPTISIA TINCTORIA ROOT; PHYTOLACCA AMERICANA ROOT; APIS MELLIFERA; ATROPA BELLADONNA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; CALCIUM SULFIDE 2; 2; 3; 3; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0160_db7177c2-aa07-45da-9f7f-208d078d6397 57520-0160 HUMAN OTC DRUG Inflammation Mangosteen, Acai, Aronia, Olibanum,, Aconitum napellus, Bryonia, Humulus lupulus, SPRAY ORAL 20100813 UNAPPROVED HOMEOPATHIC Apotheca Company ACAI; FRANKINCENSE; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; HOPS; GOLDENSEAL; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; APIS MELLIFERA; ARNICA MONTANA; HYPERICUM PERFORATUM; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 6; 6; 6; 6; 8; 200; 200; 200; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0161_ecc48202-a2b1-421b-9de3-92f1b65dfb8c 57520-0161 HUMAN OTC DRUG homeopathic HCG Cyanocobalamin, L-carnitine, Ornithine, Human chorionic gonadotropin, SPRAY ORAL 20100902 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; LEVOCARNITINE; ORNITHINE; HUMAN CHORIONIC GONADOTROPIN 6; 30; 30; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0167_3aa0436a-15ca-4667-a5b2-64f9d7d54924 57520-0167 HUMAN OTC DRUG Epstein Barr Virus Remedy Epstein Barr Virus Remedy 100X LIQUID NOT APPLICABLE 20100319 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN HERPESVIRUS 4 100 [hp_X]/mL N 20181231 57520-0171_dce9b120-a707-4698-9937-f062f735ed89 57520-0171 HUMAN OTC DRUG Epstein Barr Virus Remedy Epstein Barr Virus Remedy 12X LIQUID NOT APPLICABLE 20100319 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN HERPESVIRUS 4 12 [hp_X]/mL N 20181231 57520-0174_5d2481d6-62d3-4064-b1b5-e7c431e9f859 57520-0174 HUMAN OTC DRUG Epstein Barr Virus Remedy Spstein Barr Virus Remedy 6X LIQUID NOT APPLICABLE 20100318 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN HERPESVIRUS 4 6 [hp_X]/mL N 20181231 57520-0176_b082f269-441e-438c-8323-2539f25301f9 57520-0176 HUMAN OTC DRUG Dr Wises Formula II Intestinal Calm Lycopodium clavatum, Pulsatilla, CAPSULE ORAL 20101028 UNAPPROVED HOMEOPATHIC Apotheca Company LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 12; 12 [hp_X]/1; [hp_X]/1 N 20181231 57520-0178_5b42dc2f-1b21-4170-8238-d72eb9839a3b 57520-0178 HUMAN OTC DRUG Dr Wises Formula Intestinal Calm Lycopodium clavatum, Pulsatilla, CAPSULE ORAL 20101022 UNAPPROVED HOMEOPATHIC Apotheca Company LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 12; 12 [hp_X]/1; [hp_X]/1 N 20181231 57520-0179_acedc885-0e35-42e7-b466-2a5b177604ab 57520-0179 HUMAN OTC DRUG Bac HP Apis mellifica, Arsenicum album, Belladonna, Chamomilla, Echinacea, Lachesis mutus, Mercurius Solubilis, LIQUID ORAL 20100915 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CHAMOMILE; ECHINACEA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0181_6c6c255d-ec9c-4376-bc7e-5758004170cf 57520-0181 HUMAN OTC DRUG HCG Formula Foeniculum vulgare, Fucus vesiculosus, Lecithin, Ammonium carbonicum, Caulophyllum thalictroides, Galium aparine, Lac defloratum, Phosphorus, Phytolacca decandra, Rubus idaeus, Abrotanum, SPRAY ORAL 20101230 UNAPPROVED HOMEOPATHIC Apotheca Company FENNEL SEED; FUCUS VESICULOSUS; LECITHIN, SOYBEAN; AMMONIUM CARBONATE; CAULOPHYLLUM THALICTROIDES ROOT; GALIUM APARINE; SKIM MILK; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CHLORIDE DIHYDRATE; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SUS SCROFA THYMUS; SUS SCROFA THYROID; AMMONIUM BROMIDE; ANTIMONY TRISULFIDE; CALCIUM ARSENATE; MANGANESE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; SILICON DIOXIDE; HUMAN CHORIONIC GONADOTROPIN; RUBUS IDAEUS LEAF 2; 3; 3; 6; 6; 6; 6; 6; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 8; 8; 8; 8; 30; 30; 30; 60; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0182_ae784fde-ad2b-4330-9203-81c0cda21880 57520-0182 HUMAN OTC DRUG Extreme HCG Fucus vesiculosus, Cyanocobalamin, Glandula suprarenalis suis, Hepar suis, L-carnitine, Ornithine, Antimonium crudum, hCG, Throidinum, LIQUID ORAL 20101026 UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS; CYANOCOBALAMIN; SUS SCROFA ADRENAL GLAND; PORK LIVER; LEVOCARNITINE; ORNITHINE; ANTIMONY TRISULFIDE; HUMAN CHORIONIC GONADOTROPIN; SUS SCROFA THYROID; SODIUM SULFATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SUS SCROFA HYPOTHALAMUS; PANCRELIPASE 2; 6; 6; 6; 30; 30; 8; 60; 8; 10; 12; 18; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0190_2cda9d1f-61be-45c8-acf1-87e0d436cfdd 57520-0190 HUMAN OTC DRUG StaLean L-carnitine tartrate, L-isoleucine, L-leucine, L-valine, Magnesia phosphorica, Pyridoxine, SPRAY ORAL 20100312 UNAPPROVED HOMEOPATHIC Apotheca Company MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PYRIDOXINE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MERCURIUS SOLUBILIS; SODIUM SULFATE; NERIUM OLEANDER LEAF; SCHOENOCAULON OFFICINALE SEED; SUS SCROFA HYPOTHALAMUS; DOPAMINE; SUS SCROFA PANCREAS; SEROTONIN; SUS SCROFA SPLEEN; LEUCINE; VALINE; ISOLEUCINE; LEVOCARNITINE TARTRATE 60; 60; 200; 200; 200; 200; 200; 200; 100; 200; 200; 200; 200; 60; 60; 60; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0191_97f8d1d1-7719-4147-8b61-e4d2c7d5ee73 57520-0191 HUMAN OTC DRUG Liquid Detox Citrus limonum, Taraxacum officinale, Uva-ursi, Berberis vulgaris, Capsicum annuum, Galium aparine, Lobelia inflata, Nux vomica, Schisandra, Tylophora asthmatica, Brain, Cor, Glandula suprarenalis sui LIQUID ORAL 20100312 UNAPPROVED HOMEOPATHIC Apotheca Company LEMON JUICE; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CAPSICUM; GALIUM APARINE; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; SCHISANDRA CHINENSIS FRUIT; SUS SCROFA ADRENAL GLAND; PORK LIVER; CALCIUM SULFIDE; PORK INTESTINE; PORK KIDNEY; LACTIC ACID, DL-; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SUS SCROFA SPLEEN; SUS SCROFA THYROID; SUS SCROFA LUNG; SUS SCROFA LYMPH; TYLOPHORA INDICA ROOT; PORK BRAIN; PORK HEART 1; 2; 2; 3; 3; 3; 3; 3; 3; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 3; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0197_e40940e8-b6c7-4e6b-a89a-41b198a5796e 57520-0197 HUMAN OTC DRUG Formula 4 Calendula officinalis, Bellis Perennis, Ledum Palustre, Arnica Montana, Phosphorus LIQUID ORAL 20100329 UNAPPROVED HOMEOPATHIC Apotheca Company CALENDULA OFFICINALIS FLOWERING TOP; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; ARNICA MONTANA; PHOSPHORUS 6; 12; 12; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0201_41b0cc6a-21e5-4be6-9dec-02aa6a6c5ce2 57520-0201 HUMAN OTC DRUG Formula 8 Arnica montana, Bellis perennis, Hypericum perforatum LIQUID ORAL 20100329 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 6; 6; 12; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0203_efb7e1df-1b3f-4acc-9769-553d433c344c 57520-0203 HUMAN OTC DRUG Formula 10 Arnica montana, Bellis perennis, Phosphorus, LIQUID ORAL 20100329 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BELLIS PERENNIS; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; DELPHINIUM STAPHISAGRIA SEED 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0204_f3f7373b-aecc-4529-a9fb-508f9409bddd 57520-0204 HUMAN OTC DRUG MBM 1 Bladder Irritated Berberis vulgaris, Bladder, Thuja occidentalis, Bryonia, Hepar sulphuris calcareum, LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC Apotheca Company BERBERIS VULGARIS FRUIT; SUS SCROFA URINARY BLADDER; THUJA OCCIDENTALIS LEAFY TWIG; BRYONIA ALBA ROOT; CALCIUM SULFIDE; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; APIS MELLIFERA; BARIUM CARBONATE 3; 3; 34; 89; 89; 89; 89; 144; 144 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0205_675906ae-4cf1-4a3e-92ac-230ca611b054 57520-0205 HUMAN OTC DRUG MBM 2 Gallbladder Fel tauri, Chionanthus virginica, Nux vomica, Arsenicum album, Platinum metallicum, LIQUID ORAL 20100422 UNAPPROVED HOMEOPATHIC Apotheca Company CHIONANTHUS VIRGINICUS BARK; STRYCHNOS NUX-VOMICA SEED; ARSENIC TRIOXIDE; PLATINUM; BOS TAURUS BILE 34; 34; 233; 233; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0206_d4df3d85-618d-46ec-9336-170b1e192b35 57520-0206 HUMAN OTC DRUG MBM 3 Heart Shock Phytolacca decandra, Spongia tosta, Crocus sativus, Coffea cruda, Aurum metallicum, LIQUID ORAL 20100420 UNAPPROVED HOMEOPATHIC Apotheca Company PHYTOLACCA AMERICANA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; SAFFRON; ARABICA COFFEE BEAN; GOLD 3; 3; 34; 89; 144 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0209_db719c57-f2a5-40a7-835e-97ef7f6d2c02 57520-0209 HUMAN OTC DRUG MBM 6 Liver Chelidonium majus, Liver, Cholesterinum, Lycopodium clavatum, Tarentula hispana, Arsenicum album, Belladonna, LIQUID ORAL 20100427 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; PORK LIVER; CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; ARSENIC TRIOXIDE; ATROPA BELLADONNA 3; 3; 34; 144; 233; 233; 233 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0210_8beba2b1-0e6f-47b4-aa69-1bdff7e5be07 57520-0210 HUMAN OTC DRUG MBM 7 Lung Grief Coccus cacti, Lung, Ignatia amara, Causticum, Natrum muriaticum, LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC Apotheca Company PROTORTONIA CACTI; STRYCHNOS IGNATII SEED; CAUSTICUM; SODIUM CHLORIDE; SUS SCROFA LUNG 3; 89; 233; 233; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0211_63aa6cef-c8ba-4dfb-a840-6c0f91b32b29 57520-0211 HUMAN OTC DRUG MBM Small Intestine Condurango, Intestine, Phytolacca decandra, Aconitum napellus, Aurum metallicum, Sulphur, LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company PORK INTESTINE; PHYTOLACCA AMERICANA ROOT; ACONITUM NAPELLUS; GOLD; SULFUR; SULFUR; GOLDENSEAL; MERCURIUS SOLUBILIS; GRAPHITE; PULSATILLA VULGARIS; MARSDENIA CONDURANGO BARK 3; 3; 55; 55; 55; 89; 89; 144; 233; 233; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0212_3e14e9d3-0c6a-422f-9784-5eac9220be8c 57520-0212 HUMAN OTC DRUG MBM 9 Spleen Pancreas Ceanothus americanus, Senna, Pancreas, Spleen, Chioanthus virginica, Cinchona officinalis, Sepia, LIQUID ORAL 20100422 UNAPPROVED HOMEOPATHIC Apotheca Company CEANOTHUS AMERICANUS LEAF; SENNA LEAF; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; SEPIA OFFICINALIS JUICE; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE 3; 3; 5; 5; 34; 144; 144; 233; 233 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0213_bbde3db1-f78b-43a8-ae99-25063219ce35 57520-0213 HUMAN OTC DRUG MBM 10 Stomach Condurango, Stomach, Nux vomica, Aurum metallicum, Antimonium crudum, Hyoscyamus niger, Sulphur, LIQUID ORAL 20100422 UNAPPROVED HOMEOPATHIC Apotheca Company SUS SCROFA STOMACH; STRYCHNOS NUX-VOMICA SEED; GOLD; ANTIMONY TRISULFIDE; HYOSCYAMUS NIGER; SULFUR; MARSDENIA CONDURANGO BARK 5; 89; 144; 233; 233; 233; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0214_8d385528-9ae6-4742-a18e-8217d672ecbf 57520-0214 HUMAN OTC DRUG MBM 11 Thyroid Adrenal Iodium, Phytolacca decandra, Adrenalinum, Adrenocorticotrophin, Thyroidinum, Belladonna, Phosphorus, Calcarea carbonica, Natrum muriaticum, Nux moschata, Stramonium, Argentum nitricum, LIQUID ORAL 20100422 UNAPPROVED HOMEOPATHIC Apotheca Company IODINE; PHYTOLACCA AMERICANA ROOT; EPINEPHRINE; CORTICOTROPIN; THYROID; ATROPA BELLADONNA; PHOSPHORUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; NUTMEG; DATURA STRAMONIUM; SILVER NITRATE 3; 3; 8; 34; 34; 34; 55; 89; 89; 89; 89; 233 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0215_6ff9a84c-90f1-4ad0-86c8-32a69067b95d 57520-0215 HUMAN OTC DRUG MBM 12 Male Unresponsive Chimaphila umbellata, Pituitarinum gland, Uva-ursi, Orchitinum, Prostate, Sarsaparilla, LIQUID ORAL 20100709 UNAPPROVED HOMEOPATHIC Apotheca Company CHIMAPHILA UMBELLATA; SUS SCROFA PITUITARY GLAND; ARCTOSTAPHYLOS UVA-URSI LEAF; SUS SCROFA PROSTATE; SARSAPARILLA ROOT; GELSEMIUM SEMPERVIRENS ROOT; ZINC; POTASSIUM PHOSPHATE, DIBASIC; PHOSPHORIC ACID; SUS SCROFA TESTICLE 3; 3; 5; 8; 55; 34; 55; 144; 233; 8 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0216_931cd89e-5ecf-4cee-adf5-f5c3d0931ab7 57520-0216 HUMAN OTC DRUG MBM 13 Female Phytolacca decandra, Pituitarinum gland, Scrophularia nodosa, Hypothalamus gland, Calcarea carbonica, Cimicifuga racemosa, LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Apotheca Company PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; BLACK COHOSH; LILIUM TIGRINUM; SULFUR; CAUSTICUM; GRAPHITE; POTASSIUM PHOSPHATE, DIBASIC; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND 3; 3; 89; 89; 89; 89; 144; 144; 233; 5; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0217_10514191-5382-4ba8-9694-40ccf8e16760 57520-0217 HUMAN OTC DRUG Krebs Stimulator Plus Tabebuia impetiginosa, Uncaria tomentosa, Hypothalamus, Pituitary, Glandula suprarenalis, Nadidum, Lacticum acidum, LIQUID ORAL 20100325 UNAPPROVED HOMEOPATHIC Apotheca Company TABEBUIA IMPETIGINOSA BARK; CAT'S CLAW; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA ADRENAL GLAND; NADIDE; LACTIC ACID, DL-; LACTIC ACID, L-; COENZYME A; ADENOSINE TRIPHOSPHATE; BIS(CARBOXYETHYL)GERMANIUM SESQUIOXIDE; UBIDECARENONE 3; 3; 6; 200; 60; 12; 30; 30; 30; 30; 8; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0218_60e44ce6-90ad-4c8e-ac13-de404a08cb08 57520-0218 HUMAN OTC DRUG Allergy Composition Chondrus crispus, Glycyrrhiza glabra, Zingiber officinale, Amrposia artemisiaefolia, LIQUID ORAL 20100412 UNAPPROVED HOMEOPATHIC Apotheca Company GLYCYRRHIZA GLABRA; GINGER; HISTAMINE DIHYDROCHLORIDE; TAURINE; SCHOENOCAULON OFFICINALE SEED; IODINE; SODIUM CARBONATE; AMBROSIA ARTEMISIIFOLIA; LEVODOPA; CHONDRUS 3; 3; 4; 6; 6; 12; 12; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0219_29d1a0b3-4c84-41f3-b1a9-63d645481f2e 57520-0219 HUMAN OTC DRUG Amoebasode Triticum aestivum, Cajuputum, Baptisia tinctoria, Capsicum annuum, Columbo, Fragaria vesca, Quassia amara, LIQUID ORAL 20100412 UNAPPROVED HOMEOPATHIC Apotheca Company WHEAT; BAPTISIA TINCTORIA ROOT; CAPSICUM; JATEORHIZA CALUMBA ROOT; FRAGARIA VESCA FRUIT; QUASSIA AMARA WOOD; SENNA LEAF; WORMWOOD; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; BEEF LIVER; BOS TAURUS ADRENAL GLAND; CAJUPUT OIL; SUS SCROFA SPLEEN; AMOEBA PROTEUS; GIARDIA LAMBLIA 1; 3; 3; 3; 3; 3; 3; 6; 12; 12; 24; 30; 1; 24; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0220_de5f747c-5ac9-4ddc-aa30-88fd4f07390d 57520-0220 HUMAN OTC DRUG 1 Bladder Berberis vulgaris, Thuja occidentalis, Apis mellifica, Pulsatilla, Staphysagria, Baryta carbonica, Bryonia, Hepar sulphuris calcareum LIQUID ORAL 20100512 UNAPPROVED HOMEOPATHIC Apotheca, Company BERBERIS VULGARIS ROOT BARK; THUJA OCCIDENTALIS LEAFY TWIG; APIS MELLIFERA; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; BARIUM CARBONATE; BRYONIA ALBA ROOT; CALCIUM SULFIDE 3; 30; 200; 200; 200; 1; 1; 1 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 57520-0223_b969e9ff-3c48-494d-bf28-021e36ffcf76 57520-0223 HUMAN OTC DRUG Pure Oral hCG hCG, LIQUID ORAL 20100810 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTROPIN 200 [hp_C]/mL N 20181231 57520-0228_5ec5cdae-59cf-4784-98d8-af0bd086d05f 57520-0228 HUMAN OTC DRUG Slim Lycopodium clavatum, Phytolacca decandra, Abies canadensis, Ammonium bromatum, Ammonium muriaticum, Pulsatilla, Kali bichromicum, Ammonium carbonicum, Fucus vesiculosus, LIQUID ORAL 20101001 UNAPPROVED HOMEOPATHIC Apotheca Company LYCOPODIUM CLAVATUM SPORE; PHYTOLACCA AMERICANA ROOT; AMMONIUM BROMIDE; TSUGA CANADENSIS BARK; AMMONIUM CHLORIDE; PULSATILLA VULGARIS; POTASSIUM DICHROMATE; AMMONIUM CARBONATE; FUCUS VESICULOSUS; CAPSICUM; SILVER NITRATE; SILICON DIOXIDE; BOS TAURUS ADRENAL GLAND; CALCIUM ARSENATE; IRON; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; POTASSIUM CARBONATE; SEMECARPUS ANACARDIUM JUICE; IODINE; SUS SCROFA THYROID 3; 3; 6; 6; 200; 30; 200; 6; 200; 200; 30; 8; 200; 200; 200; 4; 1; 1; 200; 4; 4; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0231_3cb7a1c4-a44e-4f06-b80c-20e2632da6df 57520-0231 HUMAN OTC DRUG Headache Belladonna, Cimicifuga racemosa, Glonoinum, Lachesis mutus, Zingiber officinale, LIQUID ORAL 20100803 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BLACK COHOSH; NITROGLYCERIN; LACHESIS MUTA VENOM; GINGER 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0239_ded4c506-15fe-4999-bc66-767b269e2c0a 57520-0239 HUMAN OTC DRUG 2 Gallbladder Fel tauri, Chionanthus virginica, Arsenicum album, Nux vomica, Platinum metallicum, LIQUID ORAL 20100802 UNAPPROVED HOMEOPATHIC Apotheca Company CHIONANTHUS VIRGINICUS BARK; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; PLATINUM; BOS TAURUS BILE 30; 1; 1; 1; 3 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL N 20181231 57520-0241_88a97dee-8ca0-45d6-87a5-ee7165e29104 57520-0241 HUMAN OTC DRUG Dr L Advanced HCG Formula Chromium GTF, Hypothalamus, HCG, Garcinia cambogia, LIQUID ORAL 20101028 UNAPPROVED HOMEOPATHIC Apotheca Company CHROMIUM PICOLINATE; SUS SCROFA HYPOTHALAMUS; HUMAN CHORIONIC GONADOTROPIN; HYDROXYCITRIC ACID 13; 13; 34; 34 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0242_232e7157-bf42-4334-a548-4f7a3ea95426 57520-0242 HUMAN OTC DRUG 4 Kidney Argentum nitricum, Arnica montana, Aconitum napellus, Nitricum acidum, Berberis vulgaris, Solidago virgaurea, LIQUID ORAL 20100820 UNAPPROVED HOMEOPATHIC Apotheca Company SILVER NITRATE; ARNICA MONTANA; ACONITUM NAPELLUS; NITRIC ACID; BERBERIS VULGARIS ROOT BARK; SOLIDAGO VIRGAUREA FLOWERING TOP 1; 1; 1; 1; 30; 30 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0243_5029a4cb-4017-47e6-af6e-e2d469e1fe72 57520-0243 HUMAN OTC DRUG 5 Large Intestine Hyddrastis canadensis, Senna, Agaricus muscarius, Arnica montana, Baptisia tinctoria, Cuprum metallicum, Nitricum acidum, LIQUID ORAL 20100802 UNAPPROVED HOMEOPATHIC Apotheca Company GOLDENSEAL; SENNA LEAF; AMANITA MUSCARIA VAR. MUSCARIA; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; COPPER; NITRIC ACID 3; 3; 1; 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 57520-0245_9a12fa87-6629-4079-8ffb-13799046eb0e 57520-0245 HUMAN OTC DRUG 7 Lung Causticum, Natrum muriaticum, Ignatia amara, Coccus cacti, LIQUID ORAL 20100810 UNAPPROVED HOMEOPATHIC Apotheca Company CAUSTICUM; SODIUM CHLORIDE; STRYCHNOS IGNATII SEED; PROTORTONIA CACTI 1; 5; 600; 3 [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0248_546e2f66-74c5-4808-86c7-0b4adff97d22 57520-0248 HUMAN OTC DRUG 9 Spleen Pancreas Ceanothus americanus, Senna, Chionanthus virginica, Arsenicum album, Lycopodium clavatum, Sepia, LIQUID ORAL 20100802 UNAPPROVED HOMEOPATHIC Apotheca Company CEANOTHUS AMERICANUS LEAF; SENNA LEAF; CHIONANTHUS VIRGINICUS BARK; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; SEPIA OFFICINALIS JUICE 3; 3; 30; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 57520-0249_9805cbbb-63d8-475c-846b-0b59f9db0e84 57520-0249 HUMAN OTC DRUG 10 Stomach Condurango, Antimonium crudum, Aurum metallicum, Hyoscyamus niger, Nux vomica, Sulphur, LIQUID ORAL 20100803 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY TRISULFIDE; GOLD; HYOSCYAMUS NIGER; STRYCHNOS NUX-VOMICA SEED; SULFUR; MARSDENIA CONDURANGO BARK 1; 1; 1; 1; 1; 3 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL N 20181231 57520-0251_aa37ab13-8a75-4e6f-90bc-2a84a83901c4 57520-0251 HUMAN OTC DRUG 11 Thyroid Adrenal Iodium, Phytolacca decandra, Adrenalinum, Adrenocorticotrophin, Belladonna, Thyroidinum, Natrum muriaticum, LIPSTICK ORAL 20100803 UNAPPROVED HOMEOPATHIC Apotheca Company IODINE; PHYTOLACCA AMERICANA ROOT; EPINEPHRINE; CORTICOTROPIN; ATROPA BELLADONNA; THYROID; SODIUM CHLORIDE; SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; NUTMEG; PHOSPHORUS 3; 3; 6; 6; 30; 30; 200; 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 57520-0252_9519d3f4-4833-4aa2-b320-959e826ab3b9 57520-0252 HUMAN OTC DRUG 13 Female Phytolacca decandra, Scrophularia nodosa, Cimicifuga racemosa, Lilium tigrinum, Sulphur, Graphites, LIQUID ORAL 20100804 UNAPPROVED HOMEOPATHIC Apotheca Company PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; BLACK COHOSH; LILIUM TIGRINUM; SULFUR; GRAPHITE; POTASSIUM PHOSPHATE, DIBASIC; CAUSTICUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE 3; 3; 200; 1; 1; 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 57520-0254_c6e691fc-5ee3-483c-866d-dbe6af1bd2cd 57520-0254 HUMAN OTC DRUG Adrenapar Aralia quinquefolia, Avena sativa Glandula suprarenalis, Arsenicum iodatum, Ignatia amara, Lycopodium clavatum, Nux vomica, LIQUID ORAL 20101005 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; ARSENIC TRIIODIDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; ZINC 3; 3; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0265_d03e1bc2-1ddf-46b1-a40e-7eb19e1440fb 57520-0265 HUMAN OTC DRUG Trauma Free Symphytum officinale, Bellis perennis, Hypericum perforatum,, Magnesia phosphorica, Ruta graveolens, Arnica montana, LIQUID ORAL 20100729 UNAPPROVED HOMEOPATHIC Apotheca Company COMFREY ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA 3; 12; 12; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0272_e1b840f7-a357-448e-bef7-d4ed2b3a43c4 57520-0272 HUMAN OTC DRUG Fibro Relief Ferrum metallicum, Guaiacum, Lithium carbonicum, Lycopersicum esculentum, Magnesia phosphorica CAPSULE ORAL 20101217 UNAPPROVED HOMEOPATHIC Apotheca Company IRON; GUAIACUM OFFICINALE RESIN; LITHIUM CARBONATE; TOMATO; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 57520-0288_16629aa4-0a24-4733-a6a5-fb88ed6aa918 57520-0288 HUMAN OTC DRUG Hypothalmus Tincture Aralia quinquefolia, Hydrocotyle asiatica, Polygonum multiflorum, Hypothalamus, Pituitarum posterium, Germanium sesquioxide, Pineal, LIQUID ORAL 20101028 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; CENTELLA ASIATICA; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; GERMANIUM SESQUIOXIDE; SUS SCROFA PINEAL GLAND; FALLOPIA MULTIFLORA ROOT 3; 3; 8; 8; 12; 14; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0290_766836d8-d3c3-405a-9070-85cfe95c204c 57520-0290 HUMAN OTC DRUG Viral Plus Arsenicum album, Belladonna, Echinacea, Eupatorium perfoliatum, Gelsemium sempervirens, Lycopodium clavatum, Phosphoricum acidum, Phosphorus, Pyrogenium, Rhus Toxicodendron, LIQUID ORAL 20101028 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0295_0a66ee3e-50b1-4069-bc31-3132b93669c8 57520-0295 HUMAN OTC DRUG Sinutone Echinacea, Hydrastis canadensis, Allium cepa, Ambrosia artemesiaefolia, Arsenicum album, Kali bichromicum, Nux moschata, Pulsatilla, Sepia, Solidago virgaurea, LIQUID ORAL 20101110 UNAPPROVED HOMEOPATHIC Apotheca Company ECHINACEA; GOLDENSEAL; ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; POTASSIUM DICHROMATE; NUTMEG; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0297_dbd01e76-e98b-4814-9510-8113721d7434 57520-0297 HUMAN OTC DRUG Allerstat II Baptisia tinctoria, Echinacea, Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, LIQUID ORAL 20100412 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA; ONION; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; AMBROSIA ARTEMISIIFOLIA; PULSATILLA VULGARIS 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0304_3a7e9963-24ca-4102-be56-4995c1167071 57520-0304 HUMAN OTC DRUG Relaxatone Passiflora incarnata, Scutellaria lateriflora, Valeriana officinalis, Arsenicum album, Calcarea carbonica, Coffea cruda, Ignatia amara, Kali phosphoricum Lycopus virginicus, Staphysagria LIQUID ORAL 20101111 UNAPPROVED HOMEOPATHIC Apotheca Company PASSIFLORA INCARNATA TOP; SCUTELLARIA LATERIFLORA; VALERIAN; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; LYCOPUS VIRGINICUS; DELPHINIUM STAPHISAGRIA SEED 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0305_d4903c91-e50f-493d-ad3f-0fd0cb4c2147 57520-0305 HUMAN OTC DRUG Headache HP Belladonna, Bryonia, Gelsemium sempervirens, Glonionum, Melilotus officinalis, Natrum muriaticum, Nitricum acidum, Nux vomica, Silicea Spigelia anthelmia LIQUID ORAL 20100412 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; SODIUM CHLORIDE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE; MELILOTUS OFFICINALIS POLLEN; SPIGELIA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0306_30ec071d-41d5-47a5-bdd0-18c3b7ccc95d 57520-0306 HUMAN OTC DRUG Tinnitus HP Ginkgo biloba, Chininum sulphuricum, Cinchona officinalis, Graphites, Natrum salicylicum, Plumbum metallicum, LIQUID ORAL 20100412 UNAPPROVED HOMEOPATHIC Apotheca Company GINKGO; QUININE SULFATE; CINCHONA OFFICINALIS BARK; GRAPHITE; SODIUM SALICYLATE; LEAD; ASPIRIN; ALLYLTHIOUREA; SPIGELIA 6; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0307_407629b0-4a19-4eba-b1f0-3efdbf6ded73 57520-0307 HUMAN OTC DRUG Thyropar Fucus vesiculosus, Spongia tosta, Glandula suprarenalis LIQUID ORAL 20100413 UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND 3; 3; 6; 12; 12; 12; 12; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0309_1fb04c98-cf03-41e7-931a-885a2467fca3 57520-0309 HUMAN OTC DRUG Arnica Plus Arnica montana, Hamamelis virginiana, Rhus toxicodendron, GEL TOPICAL 20110315 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0310_6a532fad-5d7a-4fb2-be8d-7073377c0544 57520-0310 HUMAN OTC DRUG Recovatone Glycyrrhiza glabra, Kali muriaticum Magnesia muriatica, Tribulus terrestris, Zincum gluconicum, Kali phosphoricum, Natrum muriaticum, Iodium, Phosphorus, Adrenalinum, Adrenocorticotrophin, Ascorbicum LIQUID ORAL 20110802 UNAPPROVED HOMEOPATHIC Apotheca Company GLYCYRRHIZA GLABRA; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; TRIBULUS TERRESTRIS FRUIT; ZINC GLUCONATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; IODINE; PHOSPHORUS; EPINEPHRINE; CORTICOTROPIN; ASCORBIC ACID; CALCIUM GLUCONATE; COBALTOUS GLUCONATE; COPPER GLUCONATE; CREATINE; FERROUS GLUCONATE; GLUTAMINE; ARGININE; LEVOCARNITINE; LEUCINE; ORNITHINE; VALINE; MAGNESIUM GLUCONATE; MANGANESE GLUCONATE; POTASSIUM GLUCONATE; MOLYBDENUM; NICKEL; SELENIUM DIOXIDE; SELENIUM; STRONTIUM CARBONATE; VANADIUM; TRIBASIC CALCIUM PHOSPHATE; BORON; CHROMIUM 1; 2; 2; 2; 4; 3; 3; 4; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 9; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0311_89716561-04ff-46b6-abe2-af32767bd50e 57520-0311 HUMAN OTC DRUG Joint Rescue Symphytum officinale, Capsicum annuum, Ledum palustre, Colchicum autumnale, Rhododendron chrysanthum, Ruta graveolens, GEL TOPICAL 20110311 UNAPPROVED HOMEOPATHIC Apotheca Company COMFREY ROOT; CAPSICUM; LEDUM PALUSTRE TWIG; COLCHICUM AUTUMNALE BULB; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 3; 6; 6; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0313_8ae865b6-392b-4dad-a2a6-dd5e4728a35a 57520-0313 HUMAN OTC DRUG Tendon Rescue Bryonia, Ruta graveolens, Bellis perennis, Argentum metallicum, GEL TOPICAL 20110315 UNAPPROVED HOMEOPATHIC Apotheca Company BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; BELLIS PERENNIS; SILVER 12; 12; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0316_061c4e71-a247-4b61-81fa-44c63b60a338 57520-0316 HUMAN OTC DRUG Muscle Rescue Arnica montana, Rhus toxicodendron, Phytolacca decandra, Pulsatilla, Ruta graveolens, GEL TOPICAL 20110316 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP 3; 3; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0320_dd0611da-b165-414e-bac5-e7a113e5f6bd 57520-0320 HUMAN OTC DRUG Calcium Composition Arnica montana, Echinacea, Boron Gluconate, Symphytum officinale, Hekla lava, Calcarea carbonica, Calcarea fluorica, LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; ECHINACEA; COMFREY ROOT; HEKLA LAVA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; SILICON DIOXIDE; BORON GLUCONATE 3; 3; 30; 30; 30; 30; 30; 30; 200; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0321_7744e663-bb51-49d0-8a5c-f770729bf8cc 57520-0321 HUMAN OTC DRUG Cerebral Composition Cholinum. Capsicum annuum, Ginkgo biloba, Arnica montana, Gelsemium sempervirens, Kali Phosphoricum, Anacardium orientale, Baryta Carbonica, Phosphorus, Serotonin, LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC Apotheca Company CHOLINE HYDROXIDE; CHILI PEPPER; GINKGO; ARNICA MONTANA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM PHOSPHATE, DIBASIC; SEMECARPUS ANACARDIUM JUICE; BARIUM CARBONATE; PHOSPHORUS; SEROTONIN 3; 3; 3; 6; 6; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0322_4fed67f6-23fe-4bd9-8cba-e789a7a340c2 57520-0322 HUMAN OTC DRUG Colloidal Silver Colloidal silver, LIQUID ORAL 20100419 UNAPPROVED HOMEOPATHIC Apotheca Company SILVER 12 [hp_X]/mL N 20181231 57520-0323_d05ba894-7dbf-4d2d-b0d6-cf41f645c6aa 57520-0323 HUMAN OTC DRUG Bowel Nosode B Faecalis Bowel Nosode B Faecalis LIQUID ORAL 20100512 UNAPPROVED HOMEOPATHIC Apotheca Company SEPIA OFFICINALIS JUICE; ALCALIGENES FAECALIS 3; 30 [hp_X]/mL; [hp_C]/mL N 20181231 57520-0324_ac21ada6-dce8-4f35-a1f2-8d263c26b599 57520-0324 HUMAN OTC DRUG Lymph Detox Plus Apis mellifica, Arnica montana, Berberis vulgaris, Gelsemium sempervirens, Hydrastis canadensis, Phytolacca decandra, LIQUID ORAL 20100512 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; CHELIDONIUM MAJUS; TOXICODENDRON PUBESCENS LEAF; LACHESIS MUTA VENOM 3; 3; 3; 3; 3; 3; 3; 6; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0326_dff7af9f-4395-4ae0-bfde-194f59f30edc 57520-0326 HUMAN OTC DRUG Stomaplex Carduus marianus, Gentiana lutea, Sambucus nigra LIQUID ORAL 20100427 UNAPPROVED HOMEOPATHIC Apotheca Company GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; SENNA LEAF; SUS SCROFA STOMACH; ARSENIC TRIOXIDE; ATROPINE SULFATE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SILYBUM MARIANUM SEED 3; 3; 3; 8; 12; 12; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0329_3dc12606-c5ba-4f4d-9937-862c3fd5a8a4 57520-0329 HUMAN OTC DRUG Edemaforce Cactus grandiflorus, Calendula officinalis, Convallaria majalis, Dulcamara, Leptandra virginica, Solidago virgaurea, Apis mellifica, Arnica montana, LIQUID ORAL 20100426 UNAPPROVED HOMEOPATHIC Apotheca Company SELENICEREUS GRANDIFLORUS STEM; CALENDULA OFFICINALIS FLOWERING TOP; CONVALLARIA MAJALIS; SOLANUM DULCAMARA TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; APIS MELLIFERA; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; LEAD; SAMBUCUS NIGRA FLOWERING TOP; CULVER'S ROOT 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0332_0d7a17cf-00fe-4d96-95aa-7b9748e290eb 57520-0332 HUMAN OTC DRUG Back and Neck Rescue Hypericum perforatum, Phytolacca decandra, Guaiacum, Ledum palustre, Conium maculatum, GEL TOPICAL 20110520 UNAPPROVED HOMEOPATHIC Apotheca Company HYPERICUM PERFORATUM; PHYTOLACCA AMERICANA ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; CONIUM MACULATUM FLOWERING TOP 3; 3; 6; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0333_fda75863-412b-4b6c-9d64-e184ecbd9290 57520-0333 HUMAN OTC DRUG HCG with Slimming Herbs Fucus vesiculosus, Cyanocobalamin, Glandula suprarenalis suis, Hepar suis, L-carnitine, Ornithine, Antimonium crudum, Human chorionic gonadotropin, LIQUID ORAL 20100913 UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS; CYANOCOBALAMIN; SUS SCROFA ADRENAL GLAND; PORK LIVER; LEVOCARNITINE; ORNITHINE; ANTIMONY TRISULFIDE; HUMAN CHORIONIC GONADOTROPIN; SUS SCROFA THYROID; SODIUM SULFATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PANCRELIPASE; SUS SCROFA HYPOTHALAMUS 2; 6; 6; 6; 30; 30; 8; 60; 8; 10; 12; 12; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0336_f1e42df4-9106-4ba1-a695-c1e0970bda96 57520-0336 HUMAN OTC DRUG Muscle Ice Phytolacca deccandra, Symphytum officinale, Bellis perennis, Ledum palustre, Ruta graveolens, Magnesia phosphorica, Silicea, GEL TOPICAL 20110131 UNAPPROVED HOMEOPATHIC Apotheca Company PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE 1; 3; 6; 6; 6; 9; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0337_ae27e487-5e54-4536-a981-a03d1bd447ff 57520-0337 HUMAN OTC DRUG Smart HCG Human chorionic gonadortopin, LIQUID ORAL 20101110 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTROPIN 60 [hp_X]/mL N 20181231 57520-0340_831c05ad-762b-46ae-9ad1-6ea14ef64ccc 57520-0340 HUMAN OTC DRUG HCG Cord HCG (Human chorionic gonadotropin) LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTROPIN 200 [hp_C]/mL N 20181231 57520-0341_43c2aa9a-e1cd-41b9-bf7e-cc02880167a7 57520-0341 HUMAN OTC DRUG HCG Cord HCG (Human chorionic gonadotropin) SPRAY ORAL 20100429 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTROPIN 34 [hp_C]/mL N 20181231 57520-0345_164f2e8b-a58d-4fb7-8c14-f97a63f9ffd4 57520-0345 HUMAN OTC DRUG Sinuchron Arsenicum album, Hepar sulphuris calcareum, Hydrastis canadensis, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum muriaticum LIQUID ORAL 20100427 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0346_5176bd87-c35a-43df-8e1f-33a7bcfa0775 57520-0346 HUMAN OTC DRUG Endopar M Aralia racemosa, Sabal serrulata, Glandula suprarenalis, Orchitinum, Pituitaria Glandula, Prostate, Agnus castus, LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Apotheca Company ARALIA RACEMOSA ROOT; SAW PALMETTO; SUS SCROFA ADRENAL GLAND; SUS SCROFA PROSTATE; CHASTE TREE; CLEMATIS RECTA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA PITUITARY GLAND; SUS SCROFA TESTICLE 3; 3; 6; 6; 12; 12; 12; 12; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0347_b9bd68a6-86f9-4e36-8981-b77627635d70 57520-0347 HUMAN OTC DRUG Bronchi HP Carbo vegetabilis, Cuprum metallicum, Drosera Rotundifolia LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Apotheca Company ACTIVATED CHARCOAL; COPPER; DROSERA ROTUNDIFOLIA; CALCIUM SULFIDE; IPECAC; LACHESIS MUTA VENOM; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0348_4cc5bae8-d9f5-43f6-ab2a-72a8d7caea0d 57520-0348 HUMAN OTC DRUG Thymupar Baptisia tinctoria, Echinacea, Hydrastis canadensis LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA; GOLDENSEAL; THYMUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALCIUM SULFIDE; IRIDIUM; LACHESIS MUTA VENOM 3; 3; 3; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0349_5e209dde-2290-48bd-b3a0-25726d3a89bb 57520-0349 HUMAN OTC DRUG Colosode Taraxacum officinale, Berberis vulgaris, Rhamnus purshiana, Rheum, Cina, Arsenicum album, Aloe socotrina, Colostrum, Gallbladder, Hepar bovinum, LIQUID ORAL 20100929 UNAPPROVED HOMEOPATHIC Apotheca Company TARAXACUM OFFICINALE; BERBERIS VULGARIS ROOT BARK; FRANGULA PURSHIANA BARK; RHEUM OFFICINALE ROOT; ARTEMISIA CINA FLOWER; ARSENIC TRIOXIDE; ALOE; SUS SCROFA GALLBLADDER; BEEF LIVER; ACTIVATED CHARCOAL; PORK INTESTINE; ESCHERICHIA COLI; ARANEUS DIADEMATUS; CARBO ANIMALIS; ENTEROCOCCUS FAECALIS; MANDRAGORA OFFICINARUM ROOT; MERCURIUS SOLUBILIS; SELENIUM; VERATRUM ALBUM ROOT; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MIRABILIS; PSEUDOMONAS AERUGINOSA; INDOLE; CLOSTRIDIUM PERFRINGENS; BOTULINUM TOXIN TYPE A; GIARDIA LAMBLIA; YERSINIA ENTEROCOLITICA; COLOSTRUM HUMAN; SUS SCROFA GALLBLADDER; LACTOBACILLUS ACIDOPHILUS 1; 3; 3; 3; 12; 6; 30; 12; 12; 30; 30; 32; 12; 12; 12; 12; 12; 12; 12; 60; 60; 60; 200; 60; 60; 200; 60; 8; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0350_053cbe6f-b5f9-4b60-a683-fc24cf7285f3 57520-0350 HUMAN OTC DRUG Gold L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tryosine, Human chorionic gonadotropin, LIQUID ORAL 20100930 UNAPPROVED HOMEOPATHIC Apotheca Company LEVOCARNITINE; GLUTAMINE; ORNITHINE; TRYPTOPHAN; TYROSINE; HUMAN CHORIONIC GONADOTROPIN 6; 6; 6; 6; 6; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0351_d0bb8ac9-720d-4b67-9337-f507693656d5 57520-0351 HUMAN OTC DRUG Platinum For Women Cyanocobalamin, Glandula suprarenalis suis, Kali carbonicum, L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tryosine, Oophorinum, LIQUID ORAL 20101001 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; SUS SCROFA ADRENAL GLAND; POTASSIUM CARBONATE; LEVOCARNITINE; GLUTAMINE; ORNITHINE; TRYPTOPHAN; TYROSINE; SUS SCROFA OVARY; SUS SCROFA THYROID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; HUMAN CHORIONIC GONADOTROPIN 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 12; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0352_348e14a2-cc38-4038-8c5a-82da9a3f6bcf 57520-0352 HUMAN OTC DRUG Lyme HP Baptisia tinctoria, Echinacea, Hydrastis canadensis, Arsenicum album, Bryonia, Chelidonium majus, Colchicum autumnale Kalmia latifolia, LIQUID ORAL 20100921 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA; GOLDENSEAL; BORRELIA BURGDORFERI; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0355_da12de21-eba2-4347-baf2-d7a776759af8 57520-0355 HUMAN OTC DRUG Gastrotone Gentiana lutea, Sambucus nigra, Arsenicum album, Kali bichromicum, Lycopodium clavatum, Phosphorus, Pulsatilla Bismuthum carbonicum, LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Apotheca Company GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; ARSENIC TRIOXIDE; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; BISMUTH SUBCARBONATE 3; 3; 12; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0356_f98cb631-685a-489b-ae97-225cda2e01e9 57520-0356 HUMAN OTC DRUG ADD HP Gamma-aminobutyric acid, L-dopa, Norepinephrine, Serotonin, Adrenocorticotropin, Anacardium orientale, Arsenicum album, Baryta carbonica, Calcarea carbonica, Calcarea phosphorica, Hyoscyamus niger, Ly LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Apotheca Company .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; SEROTONIN; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; HYOSCYAMUS NIGER; LYCOPODIUM CLAVATUM SPORE; DATURA STRAMONIUM; CORTICOTROPIN; LEVODOPA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0357_9affe0a1-3f3a-4e5a-8256-2682ab3d63ab 57520-0357 HUMAN OTC DRUG Fungustat I Echinacea, Tabebuia impetiginosa, Abies nigra, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla, LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Apotheca Company ECHINACEA; TABEBUIA IMPETIGINOSA BARK; PICEA MARIANA RESIN; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SKATOLE; CANDIDA ALBICANS 3; 3; 12; 12; 12; 12; 12; 12; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0360_e34eafbf-81a9-438a-9425-230e98671e17 57520-0360 HUMAN OTC DRUG Anas Barbariae Anas Barbariae LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/mL N 20181231 57520-0362_57075482-7194-4ff6-b029-768bb3ff7948 57520-0362 HUMAN OTC DRUG Salmonella Salmonella LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 30 [hp_X]/mL N 20181231 57520-0363_a2b4738b-db33-4f58-80b6-e5fc163f3043 57520-0363 HUMAN OTC DRUG Tinnitus DX Calcarea carbonica, Carbo vegetabilis, Chininum sulphuricum, Cimicifuga racemosa, Cinchona officinalis, Coffea cruda, Graphites, Kali carbonicum, CAPSULE ORAL 20101112 UNAPPROVED HOMEOPATHIC Apotheca Company OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; QUININE SULFATE; BLACK COHOSH; CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; GRAPHITE; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM SALICYLATE; SALICYLIC ACID 30; 30; 30; 30; 30; 12; 30; 30; 30; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0364_373a0ca9-8490-405f-8d6c-a188c44751e4 57520-0364 HUMAN OTC DRUG Cherry Plum Cherry plum LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company PRUNUS CERASIFERA FLOWER 30 [hp_C]/mL N 20181231 57520-0365_7794dfb9-effe-4609-b3bd-24c7ed16f527 57520-0365 HUMAN OTC DRUG Oak Oak, LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company QUERCUS ROBUR FLOWER 30 [hp_C]/mL N 20181231 57520-0366_e03cff3f-c468-42aa-a5f7-76ab697bf2dc 57520-0366 HUMAN OTC DRUG Rock Water Rock water LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company WATER 30 [hp_C]/mL N 20181231 57520-0367_90e83056-3284-4769-b2cd-6a7c4a4918ea 57520-0367 HUMAN OTC DRUG Ferrum Phos Ferrum phosphoricum LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company FERRUM PHOSPHORICUM 30 [hp_C]/mL N 20181231 57520-0368_8689b716-9652-4f60-b0cf-41da342c6f17 57520-0368 HUMAN OTC DRUG Sepia Sepia LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company SEPIA OFFICINALIS JUICE 30 [hp_C]/mL N 20181231 57520-0369_fbad7b62-a9b9-4495-94eb-4285e15c80c3 57520-0369 HUMAN OTC DRUG Thyroid Baryta carbonica, Calcarea carbonica, Calcarea iodata LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Apotheca Company BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM IODIDE; FUCUS VESICULOSUS; IODINE; SODIUM CHLORIDE; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0370_9fc1f686-5f06-445b-9b62-9a76bac7598b 57520-0370 HUMAN OTC DRUG Liver Gallbladder Belladonna, Carduus marianus, Chelidonium majus, Colocynthis, Lycopodium clavatum, Natrum sulphuricum, Nux vomica, Phosphorus, Pulsatilla, Veratrum album LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0371_dbf289ad-3ff4-458f-aeaa-57e6987590e0 57520-0371 HUMAN OTC DRUG Otoflam HP Belladonna , Conium maculatum, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali bichromicum, mercurius solubilis, Pulsatilla, Silicea, Chamonilla LIQUID ORAL 20100608 UNAPPROVED HOMEOPATHIC Apotheca, Company ATROPA BELLADONNA; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; FERRUM PHOSPHORICUM; CALCIUM SULFIDE; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SILICON DIOXIDE; MATRICARIA RECUTITA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 57520-0372_06d4c68f-b5a8-4686-abe9-4e8b920929b4 57520-0372 HUMAN OTC DRUG L Dopa Phenolic L-dopa LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Apotheca Company LEVODOPA 30 [hp_C]/mL N 20181231 57520-0373_ba24ceb4-e6ed-4c3e-a1fa-fd9de166d65a 57520-0373 HUMAN OTC DRUG Mold Antigens Arsenicum album, Phosphorus, Pulsatilla, Sepia, Alternaria tenuis, Aspergillus niger, Rhizopus nigricans, Mucor racemosus, Pullularia pullulans, Candida albicans, Candida parapsilosis, Torula cerevisi LIQUID ORAL 20100928 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; RHIZOPUS STOLONIFER; MUCOR RACEMOSUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; SACCHAROMYCES CEREVISIAE RNA 30; 30; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0374_6fc4776f-36a3-440f-9abf-8da18314477e 57520-0374 HUMAN OTC DRUG Anxiety Arsenicum album, Calcarea carbonica, Ignatia amara, Kali carbonicum, Lachesis mutus, Natrum muriaticum, Phosphorus, Pulsatilla, Staphysagria LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0375_c0af72aa-bfd6-4e9e-b206-eee04b27fd1e 57520-0375 HUMAN OTC DRUG Bone Repair HP Calcarea carbonica, Calcarea Fluorica, Calcarea phosphorica, Hekla lava, Hydrofluoricum acidum, Magnesia phosphorica Rhus toxicodendron, Ruta graveolens, Silicea, Symphytum officinale LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; HEKLA LAVA; HYDROFLUORIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; COMFREY ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0376_db355a8f-887d-4206-89e9-fb9012d0be04 57520-0376 HUMAN OTC DRUG Cold Aconitum napellus, Allium cepa, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Kali bichromicum, Nercurius solubilis, Nux vomica, Pulsatilla LIQUID ORAL 20100430 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ONION; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0377_ee09401b-0b40-493e-bb6e-6656842c1496 57520-0377 HUMAN OTC DRUG Allerpoll Allium cepa, Ambrosia artemisiaefolia, Apis mellifica LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Apotheca Company ONION; APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; AMBROSIA ARTEMISIIFOLIA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0378_732b1bcb-def6-4eb1-99d0-b2fb3bb6886d 57520-0378 HUMAN OTC DRUG Gaba Phenolic Gamma-aminobutyric acid LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Apotheca Company .GAMMA.-AMINOBUTYRIC ACID 30 [hp_C]/mL N 20181231 57520-0381_06b15025-3a37-4268-8714-26ae933cf851 57520-0381 HUMAN OTC DRUG Pancreapar Hydrastis canadensis, Syzgium jambolanum, Glandula suprarenalis, Pancreas, Pituitaris glandula Phaseolus, LIQUID ORAL 20100507 UNAPPROVED HOMEOPATHIC Apotheca Company GOLDENSEAL; SYZYGIUM CUMINI SEED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PANCREAS; KIDNEY BEAN; ACETIC ACID; LACTIC ACID, DL-; PHOSPHORIC ACID; PHOSPHORUS; URANYL NITRATE HEXAHYDRATE; SUS SCROFA PITUITARY GLAND 3; 3; 6; 6; 9; 12; 12; 12; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0382_e0719005-fdad-486f-bdba-13fc23fb6bfd 57520-0382 HUMAN OTC DRUG HCG Select Female Vitality Formula Fucus vesiculosus, Cyanocobalamin, Glandula suprarenalis suis, Hepar suis, Oophorinum, Human chorionic gonadotropin, LIQUID ORAL 20100901 UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS; CYANOCOBALAMIN; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA OVARY; HUMAN CHORIONIC GONADOTROPIN; SUS SCROFA THYROID; GRAPHITE; PANCRELIPASE; THUJA OCCIDENTALIS LEAFY TWIG; SUS SCROFA HYPOTHALAMUS 2; 6; 6; 6; 6; 60; 8; 12; 12; 12; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0385_a0a168d2-adb3-4de7-9f40-d9bfa591214f 57520-0385 HUMAN OTC DRUG Relax Histaminum hydrochloricum, Dopamine, Kidney, L-theanine, Penylethylamine hydrochloricum, SPRAY ORAL 20101230 UNAPPROVED HOMEOPATHIC Apotheca Company HISTAMINE DIHYDROCHLORIDE; DOPAMINE; PORK KIDNEY; THEANINE; PHENETHYLAMINE HYDROCHLORIDE 6; 12; 12; 12; 24 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0386_9cc82786-d11e-4404-b80c-50ffecbee270 57520-0386 HUMAN OTC DRUG Emotional Balance Rauwolfia serpentina, SPRAY ORAL 20101230 UNAPPROVED HOMEOPATHIC Apotheca Company RAUWOLFIA SERPENTINA 24 [hp_C]/mL N 20181231 57520-0387_8037ebe4-249d-4d7a-b19d-9706bed2650b 57520-0387 HUMAN OTC DRUG hCG Detox Human chorionic gonadotropin (hCG), LIQUID ORAL 20101210 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN CHORIONIC GONADOTROPIN 60 [hp_X]/mL N 20181231 57520-0390_a29600c8-b806-4f51-b664-da8b49f7e91a 57520-0390 HUMAN OTC DRUG Night Shade Antigen Chili pepper, Green pepper, Potato, Tobacco, Tomato, Eggplant, Nux vomica, Pulsatilla, LIQUID ORAL 20100804 UNAPPROVED HOMEOPATHIC Apotheca Company CAPSICUM; GREEN BELL PEPPER; POTATO; TOBACCO LEAF; TOMATO; EGGPLANT; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; PHOSPHORUS; ALUMINUM; ARSENIC TRIOXIDE 30; 30; 30; 30; 30; 30; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0391_08268a0b-dc44-4ba0-abbf-e73af0f80de6 57520-0391 HUMAN OTC DRUG Muscle Matrix Arginine, L-carnitine, Ornithine, LIQUID ORAL 20101209 UNAPPROVED HOMEOPATHIC Apotheca Company ARGININE; LEVOCARNITINE; ORNITHINE 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0396_528b4ced-69f9-4c42-a257-dc4a0a0e01df 57520-0396 HUMAN OTC DRUG Muscle Rescue Arnica montana, Rhus Toxicodendron, Phytolacca decandra, Pulsatilla, Ruta graveolens, GEL TOPICAL 20110520 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP 3; 3; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0398_c3e70690-16e5-4dad-8f29-16b6a6f82e81 57520-0398 HUMAN OTC DRUG Zyvestra Cocculus indicus, Ferrum metallicum, Gelsemium sempervirens, Phytolacca decandra, Pulsatilla, Silicea, TABLET ORAL 20101203 UNAPPROVED HOMEOPATHIC Apotheca Company ANAMIRTA COCCULUS SEED; IRON; GELSEMIUM SEMPERVIRENS ROOT; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE 55; 55; 55; 55; 55 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0399_439c006f-c5d3-4143-b611-ec6e719ca0e4 57520-0399 HUMAN OTC DRUG Tendon Rescue Bryonia, Ruta graveolens, Bellis perennis, Argentum metallicum, GEL TOPICAL 20110224 UNAPPROVED HOMEOPATHIC Apotheca Company BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; BELLIS PERENNIS; SILVER 12; 12; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0401_5a5d4db8-421a-4837-aedd-920257b2754b 57520-0401 HUMAN OTC DRUG Acetylcholine Chloride Phenolic Acetylcholine chloride, LIQUID ORAL 20100507 UNAPPROVED HOMEOPATHIC Apotheca Company ACETYLCHOLINE CHLORIDE 30 [hp_C]/mL N 20181231 57520-0402_264ff3cb-5231-4cc2-96bf-0ed4f1f2e152 57520-0402 HUMAN OTC DRUG Nausea Vomiting HP Aethusa cynapium, Arsenicum album, Cocculus indicus, Ipecacuanha, Kreosotum, Petroleum, Pulsatilla, Sanguinaria canadensis, Tabacum, LIQUID ORAL 20100507 UNAPPROVED HOMEOPATHIC Apotheca Company AETHUSA CYNAPIUM; ARSENIC TRIOXIDE; ANAMIRTA COCCULUS SEED; IPECAC; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; TOBACCO LEAF; KEROSENE; WOOD CREOSOTE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0403_f8ef92e3-30a6-41a1-a67f-11c41bd765d9 57520-0403 HUMAN OTC DRUG Quercetin Phenolic Quercetin, LIQUID ORAL 20100510 UNAPPROVED HOMEOPATHIC Apotheca Company QUERCETIN 30 [hp_C]/mL N 20181231 57520-0404_eb3d9ff6-7f4c-4068-aabe-406e6ced5ffa 57520-0404 HUMAN OTC DRUG Progesterone Phenolic Progesterone, LIQUID ORAL 20100510 UNAPPROVED HOMEOPATHIC Apotheca Company PROGESTERONE 30 [hp_C]/mL N 20181231 57520-0405_557342b8-9ec9-49d5-9565-3466c0e697bd 57520-0405 HUMAN OTC DRUG Artalgia Carduus marianus, Arnica montana, Agaricus muscarius, Baryta carbonica, Bellis perennis, Glonoinum, Hamamelis virginiana, Mercurius solubilis, Plumbum metallicum, Secale cornutum, Vanadium metallicum, LIQUID ORAL 20100506 UNAPPROVED HOMEOPATHIC Apotheca Company SILYBUM MARIANUM SEED; ARNICA MONTANA; ARNICA MONTANA; AMANITA MUSCARIA VAR. MUSCARIA; BARIUM CARBONATE; BELLIS PERENNIS; NITROGLYCERIN; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MERCURIUS SOLUBILIS; LEAD; CLAVICEPS PURPUREA SCLEROTIUM; VANADIUM; ACTIVATED CHARCOAL; HYPERICUM PERFORATUM; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0406_e27b57de-957d-4b21-82a5-6b5a45232669 57520-0406 HUMAN OTC DRUG Star of Bethlehem Star-of-Bethlehem LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company ORNITHOGALUM UMBELLATUM 30 [hp_C]/mL N 20181231 57520-0407_384a3edd-b7ce-4337-b930-5cfb2a94e72b 57520-0407 HUMAN OTC DRUG PMS Tone Angelica archangelica, Cimicifuga racemosa, LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; FUCUS VESICULOSUS; COPPER; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; CANIS LUPUS FAMILIARIS MILK 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0409_fc0ff145-1ec5-409e-babf-7fdd080e6dbc 57520-0409 HUMAN OTC DRUG Anxiety Aconitum napellus, Arsenicum album, Belladonna, Calcarea carbonica, Carcinosin, Causticum, Gelsemium sempervirens, Lachesis mutus, SPRAY ORAL 20100909 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; MERCURY; NITRIC ACID; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; HUMAN BREAST TUMOR CELL; HUMAN BREAST TUMOR CELL 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0410_c3309fcb-e48c-4357-a781-9439c6f20d1d 57520-0410 HUMAN OTC DRUG Thyrostat Fucus vesiculosus, Spongia tosta, Pituitaria glandula, Thyroidinum, Arsenicum iodatum, LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; THYROID; ARSENIC TRIIODIDE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; SODIUM CHLORIDE; SUS SCROFA PITUITARY GLAND; LYCOPUS VIRGINICUS 3; 3; 6; 12; 12; 12; 12; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0411_80aeca4f-f7b8-427f-8bf2-75f6a9fe800f 57520-0411 HUMAN OTC DRUG Bronchitone Echinacea, Lobelia inflata, Antimonium tartaricum, Aralia racemosa, Drosera, Ipecacuanha, Kali Carbonicum, Phosphorus, Spongia tosta LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company ECHINACEA; LOBELIA INFLATA; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; DROSERA ROTUNDIFOLIA; IPECAC; POTASSIUM CARBONATE; PHOSPHORUS; SPONGIA OFFICINALIS SKELETON, ROASTED 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0413_bf47ad4a-c1a8-4ff8-a1f7-5ff5308c5018 57520-0413 HUMAN OTC DRUG Hepapar Carduus marianus, Chelidonium majus, Taraxacum officinale LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; TARAXACUM OFFICINALE; CHENOPODIUM AMBROSIOIDES; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 3; 3; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0414_89486a2b-24b3-4439-83de-9df84c0a312c 57520-0414 HUMAN OTC DRUG ALZ HP Anacardium orientale, Belladonna, Hyoscyamus LIQUID ORAL 20100625 UNAPPROVED HOMEOPATHIC Apotheca Company SEMECARPUS ANACARDIUM JUICE; ATROPA BELLADONNA; HYOSCYAMUS NIGER; POTASSIUM BROMIDE; BARIUM CARBONATE; LACHESIS MUTA VENOM; PHOSPHORUS; DATURA STRAMONIUM; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 57520-0415_a7f7f45f-7ebd-4634-bbf8-ec5a50dbbd04 57520-0415 HUMAN OTC DRUG Gastropanpar Pancreas, Stomach, Arsenicum album, Graphites, Lycopodium clavatum, Nux vomica, Phosphorus, Syzygium jambolanum, LIQUID ORAL 20100528 UNAPPROVED HOMEOPATHIC Apotheca Company SUS SCROFA PANCREAS; SUS SCROFA STOMACH; ARSENIC TRIOXIDE; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SYZYGIUM CUMINI SEED 30; 30; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0416_163628d9-5349-44ed-9890-c8d0df625d66 57520-0416 HUMAN OTC DRUG Asthma HP Arsenicum album, Belladonna, Blatta orientalis, Ipecacuanha, Kali carbonicum, Lobelia inflata, Natrum sulphuricum, Silicea LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLATTA ORIENTALIS; IPECAC; POTASSIUM CARBONATE; LOBELIA INFLATA; SODIUM SULFATE; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0417_30ba16dc-4dc2-4568-8d4b-028f846e2e99 57520-0417 HUMAN OTC DRUG Cystotone Sarsaparilla, Uva-ursi, Arsenicum album, Cantharis, Pareira brava, Pulsatilla, Sepia, Terebinthina, Populus tremuloides LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company SARSAPARILLA; ARCTOSTAPHYLOS UVA-URSI LEAF; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CHONDRODENDRON TOMENTOSUM ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; POPULUS TREMULOIDES LEAF; TURPENTINE 3; 3; 12; 12; 12; 12; 12; 15; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0418_9da142fc-8c52-4410-8cfd-b496ebe3a11d 57520-0418 HUMAN OTC DRUG Allerstat I Chelidonium majus, Echinacea, Gentiana lutea, Arsenicum album, Carbo vegetabilis, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; ECHINACEA; GENTIANA LUTEA ROOT; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0419_439dfa56-a1e1-48d8-88d1-80491d221d7c 57520-0419 HUMAN OTC DRUG Musco MXT Eleuthero, Epiphegus virginiana, Lacticum acidum, Tecoma pentaphylla, Hydrocotyle asiatica, Hydrocyanicum acidum, LIQUID ORAL 20100614 UNAPPROVED HOMEOPATHIC Apotheca Company ELEUTHERO; LACTIC ACID, DL-; CENTELLA ASIATICA; HYDROGEN CYANIDE; EPIFAGUS VIRGINIANA; TABEBUIA HETEROPHYLLA BARK 15; 15; 100; 100; 15; 15 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0421_fe56a0e4-7fea-4f91-83be-dd1a6d6c3b5e 57520-0421 HUMAN OTC DRUG Rehydrate Avena sativa, Equisetum hyemale, Hypericum perforatum, Ulmus fulva, Glycyrrha glabra, Pueraria lobata, LIQUID ORAL 20100614 UNAPPROVED HOMEOPATHIC Apotheca Company AVENA SATIVA FLOWERING TOP; EQUISETUM HYEMALE; HYPERICUM PERFORATUM; GLYCYRRHIZA GLABRA; PUERARIA MONTANA VAR. LOBATA ROOT; ADENOSINE TRIPHOSPHATE; GERMANIUM SESQUIOXIDE; HYDROGEN; OXYGEN; ULMUS RUBRA BARK; WATER 3; 4; 6; 12; 12; 30; 30; 30; 30; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 57520-0422_ab27b164-3e7c-4757-973d-a05f5d9b1e51 57520-0422 HUMAN OTC DRUG AsthmaClear Ambrosia artemisiaefolia, Antimonium tartaricum, Carbo vegetabilis, Ipecacuanha, Kali carbonicum, Lobelia inflata, Oxygenium, CAPSULE ORAL 20100602 UNAPPROVED HOMEOPATHIC Apotheca Company ANTIMONY POTASSIUM TARTRATE; ACTIVATED CHARCOAL; IPECAC; POTASSIUM CARBONATE; LOBELIA INFLATA; PHOSPHORUS; PULSATILLA VULGARIS; SAMBUCUS NIGRA SUBSP. CANADENSIS FLOWERING TOP; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; AMBROSIA ARTEMISIIFOLIA; OXYGEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 57520-0423_f15a4fae-b01a-4016-8fe2-f99517e61ff5 57520-0423 HUMAN OTC DRUG Migraine Relief Belladonna, Bryonia, Cyclamen europaeum, Gelsemium sempervirens, Sanguianaria canadensis, Spigelia anthelmia CAPSULE ORAL 20101006 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; BRYONIA ALBA ROOT; CYCLAMEN PURPURASCENS TUBER; GELSEMIUM SEMPERVIRENS ROOT; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA 10; 10; 8; 6; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0424_a434d123-4144-40a0-8914-0cdbf3eeea31 57520-0424 HUMAN OTC DRUG Restless Legs Relief Gnaphalium polycephalum, Viscum album, Aconitum napellus, Ledum palustre, Magnesia phosphorica, Rhus toxicodendron, TABLET ORAL 20101116 UNAPPROVED HOMEOPATHIC Apotheca Company PSEUDOGNAPHALIUM OBTUSIFOLIUM; VISCUM ALBUM FRUITING TOP; ACONITUM NAPELLUS; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 4; 4; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0425_3b5b4bdf-9afa-4663-a9b4-492df3bf0ded 57520-0425 HUMAN OTC DRUG Type 3 Sinus Regular Silicea, Hydrastis canadensis, Kali bichromicum, Calcarea carbonica, TABLET ORAL 20100603 UNAPPROVED HOMEOPATHIC Apotheca Company SILICON DIOXIDE; GOLDENSEAL; POTASSIUM DICHROMATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE 2; 6; 6; 12 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 57520-0426_0dafd9c3-c46a-4cbf-a713-3e2ea4d5875c 57520-0426 HUMAN OTC DRUG Type 3 Sinus Max Calcarea carbonica, Hydrastis canadensis, Kali bichromicum, Silicea, TABLET ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company OYSTER SHELL CALCIUM CARBONATE, CRUDE; GOLDENSEAL; POTASSIUM DICHROMATE; SILICON DIOXIDE 200; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg N 20181231 57520-0427_8a97bdae-acc6-447c-88d6-d43b3a952e8d 57520-0427 HUMAN OTC DRUG Type 4 Noise Regular Causticum, Chininum sulphuricum, Cinchona officinalis, Pulsatilla, Thiosinaminum, TABLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Apotheca Company CAUSTICUM; QUININE SULFATE; CINCHONA OFFICINALIS BARK; PULSATILLA VULGARIS; ALLYLTHIOUREA 3; 3; 6; 6; 6 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 57520-0428_3f06b0ee-59c2-4a90-a680-f863b12b40cb 57520-0428 HUMAN OTC DRUG Type 4 Noise Max Causticum, Chininum sulphuricum, Cinchona officinalis Pulsatilla, Thiosinaminum, TABLET ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company CAUSTICUM; QUININE SULFATE; CINCHONA OFFICINALIS BARK; PULSATILLA VULGARIS; ALLYLTHIOUREA 200; 200; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg N 20181231 57520-0429_4c24e149-8f3e-498d-8139-5c2bc8c26ed2 57520-0429 HUMAN OTC DRUG Type 7 Stress Anxiety Regular Kali phosphoricum, Phosphoricum acidum, Sepia, Sulphus Calcarea carbonica, Silicea, TABLET ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company POTASSIUM PHOSPHATE, DIBASIC; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE 3; 6; 6; 6; 12; 12 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 57520-0430_1c6dbf78-6b9e-48b8-826d-5a2ede6d652a 57520-0430 HUMAN OTC DRUG Type 7 Stress Anxiety Max Calcarea carbonica, Kali phosphoricum, Phosphoricum acidum, Sepia, Silicea, Sulphur, TABLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Apotheca Company OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM PHOSPHATE, DIBASIC; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; SULFUR 200; 200; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg N 20181231 57520-0431_a5500e1f-9d32-46c3-8f61-adfb785108ff 57520-0431 HUMAN OTC DRUG Type 11 Dizziness Regular Belladonna, Phosphorus, Pulsatilla, Calcarea carbonica, Silicea, TABLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; PHOSPHORUS; PULSATILLA VULGARIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE 6; 6; 6; 12; 12 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 57520-0432_58cf025e-cbd8-47e9-b5d6-3fa3e608d040 57520-0432 HUMAN OTC DRUG Type 11 Dizziness Max Belladonna, Calcarea carbonica, Phosphorus, Pulsatilla, Silicea, TABLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE 200; 200; 200; 200; 200 [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg; [hp_C]/mg N 20181231 57520-0434_65dbd6d0-d7d5-4ffb-ba2b-7a5b01673a1b 57520-0434 HUMAN OTC DRUG Hypothalmupar Aralia quinquefolia, Ginkgo biloba, Hydrocotyle asiatica LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; GINKGO; CENTELLA ASIATICA; PORK BRAIN; SUS SCROFA HYPOTHALAMUS; PHOSPHORUS; SILICON DIOXIDE; SUS SCROFA PITUITARY GLAND 3; 3; 3; 6; 6; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0435_206a8520-8253-41d5-9400-88ae5f0f13c1 57520-0435 HUMAN OTC DRUG Dentastat Allium sativum, Berberis vulgaris, Fucus vesiculosus, Phytolacca decandra, Argentum metallicum, Aurum metallicum, Calcarea fluorica, Calcarea phosphorica, Iodium, Mercurius solubilis, Niccolum metalli LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company GARLIC; BERBERIS VULGARIS ROOT BARK; FUCUS VESICULOSUS; PHYTOLACCA AMERICANA ROOT; SILVER; GOLD; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; IODINE; MERCURIUS SOLUBILIS; NICKEL; PLATINUM; SILICON DIOXIDE; ZINC 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0436_6b9689b3-182e-4007-a173-4fbb27fa8747 57520-0436 HUMAN OTC DRUG Diabenex HP Aceticum acidum, Colchicum autumnale, Lacticum acidum, Lycopodium clavatum, Phosphoricum acidum, Phosphorus, Syzgium jambolanum, Uranium nitricum LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company ACETIC ACID; COLCHICUM AUTUMNALE BULB; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; URANYL NITRATE HEXAHYDRATE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0438_8097549e-729a-43dd-ad26-0edfbf299a55 57520-0438 HUMAN OTC DRUG Adrenapar Aralia quinquefolia, Avena sativa, Glandula suprarenalis LIQUID ORAL 20100525 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; ARSENIC TRIIODIDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; ZINC 3; 3; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0439_32ef0907-e0bf-4161-8a91-f5784055b191 57520-0439 HUMAN OTC DRUG Bactestat Baptisia tinctoria, Echinacea, Phytolacca decandra, Aconitum napellus, Arsenicum album, Belladonna, Ferrum phosphoricum, Lachesis mutus, Phosphorus LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA; PHYTOLACCA AMERICANA ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0450_fcd3a5f2-afbd-4f7f-9c92-9a77a0de1e4d 57520-0450 HUMAN OTC DRUG Restless Legs Relief Aconitum napellus, Gnaphalium polycephalum, Ledum palustre, Magnesia phosphorica, Rhus Toxicodendron, Viscum album TABLET ORAL 20101111 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 6; 4; 6; 6; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0453_988a56bb-dde6-4129-a34a-02f008af2b6c 57520-0453 HUMAN OTC DRUG hcgPLUS Coenzyme Q-10, Cyanocobalamin, Folic acid, L-carnitine, Taurine, Biotin, Proline, LIQUID ORAL 20100802 UNAPPROVED HOMEOPATHIC Apotheca Company UBIDECARENONE; CYANOCOBALAMIN; FOLIC ACID; LEVOCARNITINE; TAURINE; BIOTIN; PROLINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SOMATROPIN 6; 6; 6; 6; 6; 8; 8; 30; 30; 34 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 57520-0455_3eb9b1e5-5e8a-4cc5-8889-18ddb891cd2e 57520-0455 HUMAN OTC DRUG Hot Flash Rescue Capsicum annuum, Pulsatilla, Sanguinaria canadensis, LOTION TOPICAL 20110621 UNAPPROVED HOMEOPATHIC Apotheca Company CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0461_1fbdb6ba-5cce-4745-a663-a4b4e41fec75 57520-0461 HUMAN OTC DRUG Bio Gentian Gentian, LIQUID ORAL 20100603 UNAPPROVED HOMEOPATHIC Apotheca Company GENTIANA LUTEA ROOT 200 [hp_C]/mL N 20181231 57520-0463_fce97825-532b-4e4d-b1b7-dc01bcd3a8b9 57520-0463 HUMAN OTC DRUG Fungustat I Ecninacea, Tabebuia impetiginosa, Abies nigra, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla, LIQUID ORAL 20100602 UNAPPROVED HOMEOPATHIC Apotheca Company ECHINACEA; TABEBUIA IMPETIGINOSA BARK; PICEA MARIANA RESIN; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SKATOLE; CANDIDA ALBICANS 3; 3; 12; 12; 12; 12; 12; 12; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0464_773ea16a-07da-46d9-b4e1-3ade3b41c9dc 57520-0464 HUMAN OTC DRUG Bac HP Apis mellifica, Arsenicum album, Belladonna, Chamomilla, Ecinacea, Lachesis mutus, Mercurius solubilis, LIQUID ORAL 20100602 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; ECHINACEA; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0470_4e6f48a4-f792-4bae-9c9c-adea946215c9 57520-0470 HUMAN OTC DRUG Sciatic Rescue Phytolacca decandra, Gnaphalium polycephalum, Colocynthis, Gelsemium sempervirens, GEL TOPICAL 20110620 UNAPPROVED HOMEOPATHIC Apotheca Company PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT 1; 3; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0472_dd0167ce-c3fc-4012-b598-367f439472ec 57520-0472 HUMAN OTC DRUG Sciatic Rescue Phytolacca decandra, Gnaphalium polycephalum, Colocynthis, Gelsemium sempervirens, GEL TOPICAL 20111121 UNAPPROVED HOMEOPATHIC Apotheca Company PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT 1; 3; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0473_31b1d7cb-7c65-4615-87a8-94794e515c4c 57520-0473 HUMAN OTC DRUG HCGDelivery com Cyanocobalamin(B-12), Glandula suprarenalis suis(adrenal), Hepar suis(liver), Thyroidinum, Magnesia phosphorica, Natrum phosphoricum, Human chorionic gonadotropin(HCG), LIQUID ORAL 20101210 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA THYROID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; HUMAN CHORIONIC GONADOTROPIN 60; 60; 60; 60; 60; 60; 34 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 57520-0479_37d28834-1b1b-4550-8512-3b2f92c9f5b8 57520-0479 HUMAN OTC DRUG Hepastat Beta vulgaris, Carduus marianus, Taraxacum officinale, Cholesterinum, Fel tauri, Chelidonium majus, Lycopodium clavatum, LIQUID ORAL 20100604 UNAPPROVED HOMEOPATHIC Apotheca Company BETA VULGARIS; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE; CHOLESTEROL; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; BOS TAURUS BILE 3; 3; 3; 6; 12; 12; 12; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0480_d76778e0-9fc4-4382-9569-3f0fc4e06624 57520-0480 HUMAN OTC DRUG Envirostat Berberis vulgaris, Chelidonium majus, Lappa major, Phytolacca Decandra, Calcarea fluorica, Carbo animalis, Nux vomica, LIQUID ORAL 20100604 UNAPPROVED HOMEOPATHIC Apotheca Company BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; CALCIUM FLUORIDE; CARBO ANIMALIS; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0481_8bf94eaf-01fc-45d7-b331-3c4395c3fa49 57520-0481 HUMAN OTC DRUG Arnica Plus Arnica montana, Hamamelis virginiana, Rhus toxicodendron, GEL TOPICAL 20110113 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0484_19cc1248-4668-41db-be1f-2fc083050a74 57520-0484 HUMAN OTC DRUG Muscle Ice Phytolacca decandra, Symphytum officinale, Bellis perennis, Ledum palustre, Ruta graveolens, Magnesia phosphorica, Silicea, GEL TOPICAL 20110119 UNAPPROVED HOMEOPATHIC Apotheca Company PHYTOLACCA AMERICANA ROOT; COMFREY LEAF; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE 1; 3; 6; 6; 6; 9; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0493_c51c5d5d-792b-4534-83d6-4b0e76d38760 57520-0493 HUMAN OTC DRUG 3 Heart Phytolacca decandra, Spongia tosta, Aurum metallicum, Coffea cruda Crocus sativus, LIQUID ORAL 20100623 UNAPPROVED HOMEOPATHIC Apotheca Company PHYTOLACCA AMERICANA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; GOLD; ARABICA COFFEE BEAN; SAFFRON 3; 3; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 57520-0494_b0489ac0-01f8-40f2-ab76-9e22af921bb2 57520-0494 HUMAN OTC DRUG 12 Male Reproductive Chimaphila umbellata, Pituitary, Sabal serrulata, Uva-ursi, Gelsemium sempervirens, Sarsaparilla, Kali phosphoricum, Phosphoricum acidum, Zincum metallicum LIQUID ORAL 20100618 UNAPPROVED HOMEOPATHIC Apotheca Company CHIMAPHILA UMBELLATA; SUS SCROFA PITUITARY GLAND; SAW PALMETTO; ARCTOSTAPHYLOS UVA-URSI LEAF; GELSEMIUM SEMPERVIRENS ROOT; SARSAPARILLA; POTASSIUM PHOSPHATE, DIBASIC; PHOSPHORIC ACID; ZINC 3; 3; 6; 6; 30; 30; 1; 1; 1 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 57520-0495_a2ca7ad9-b791-433c-b56f-021fc11cd260 57520-0495 HUMAN OTC DRUG Virustat Echinacea, Hydrastis canadensis, Lomatium, Acontium Napellus LIQUID ORAL 20100622 UNAPPROVED HOMEOPATHIC Apotheca Company ECHINACEA; GOLDENSEAL; LOMATIUM; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; TOXICODENDRON PUBESCENS LEAF; RANCID BEEF 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0497_6f501b18-c7cb-4410-90ad-40e5cd4713d1 57520-0497 HUMAN OTC DRUG Allerstat II Baptisia tinctoria, Echinacea, Allium cepa LIQUID ORAL 20100607 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA; ONION; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; AMBROSIA ARTEMISIIFOLIA 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0498_c1730749-f8c4-4490-bb7d-117911de4db9 57520-0498 HUMAN OTC DRUG Parastat Artemisia vulgaris, Cina, Filix mas, Sabadilla, Spigelia anthelmia, LIQUID ORAL 20100622 UNAPPROVED HOMEOPATHIC Apotheca Company ARTEMISIA VULGARIS ROOT; DRYOPTERIS FILIX-MAS ROOT; SCHOENOCAULON OFFICINALE SEED; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SULFUR; TURPENTINE; SPIGELIA; ARTEMISIA CINA FLOWER 3; 3; 3; 12; 12; 12; 12; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0501_be442d33-a554-45ff-beb3-2cbe81b281b9 57520-0501 HUMAN OTC DRUG Bactestat Baptisia tinctoria, Echinacea, Phytolacca decandra LIQUID ORAL 20100614 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA; PHYTOLACCA AMERICANA ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0502_5011a034-d9c5-48ab-b8e1-786273963a15 57520-0502 HUMAN OTC DRUG HCG Cleanse Abrotanum, Anacardium orientale, Arsenicum album, Baryta muriatica, Helleborus niger, Ignatia amara, Lycopodium clavatum, SPRAY ORAL 20100811 UNAPPROVED HOMEOPATHIC Apotheca Company ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CHLORIDE DIHYDRATE; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SUS SCROFA THYMUS; SUS SCROFA THYROID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; HUMAN CHORIONIC GONADOTROPIN; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0503_acaf0551-6fdf-4a5e-b215-947adc55f375 57520-0503 HUMAN OTC DRUG Dr. L Advanced HCG Formula Chromium GTF, Hypothalamus, HCG, Garcina cambogia, LIQUID ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company BOS TAURUS HYPOTHALAMUS; CHORIOGONADOTROPIN ALFA; CHROMIUM PICOLINATE; HYDROXYCITRIC ACID 13; 34; 13; 34 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0504_158c3581-a313-48a6-9482-0ac6c9b608d0 57520-0504 HUMAN OTC DRUG MP Achyrocline satureioides, Arctostaphylos uva-ursi, Cassia occidentalis, Mirailis jalapa, Petiveria alliacea, Physalis angulata, Schinus molle, LIQUID ORAL 20101027 UNAPPROVED HOMEOPATHIC Apotheca Company ARCTOSTAPHYLOS UVA-URSI LEAF; ACHYROCLINE SATUREIOIDES; SENNA OCCIDENTALIS; MIRABILIS JALAPA TOP; PHYSALIS ANGULATA; SCHINUS MOLLE BARK; PETIVERIA ALLIACEA ROOT 32; 32; 32; 32; 32; 32; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0505_09e2c99b-6201-44ae-90d7-65c93417b896 57520-0505 HUMAN OTC DRUG Parasite Detox Filix mas, Granatum, Juglans regia, Rhamnus purshiana, Absinthium, Aesculus hippocastanum, Arsenicum album, Baptisia tinctoria, LIQUID ORAL 20100623 UNAPPROVED HOMEOPATHIC Apotheca Company DRYOPTERIS FILIX-MAS ROOT; FRANGULA PURSHIANA BARK; WORMWOOD; HORSE CHESTNUT; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; COPPER; IPECAC; LYCOPODIUM CLAVATUM SPORE; MERCURY; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; KRAMERIA LAPPACEA ROOT; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SANTONIN; SILICON DIOXIDE; TEUCRIUM MARUM; SPIGELIA ANTHELMIA; JUGLANS REGIA LEAF; ARTEMISIA CINA FLOWER; PUNICA GRANATUM ROOT BARK 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0514_1f275616-395a-4a30-9a92-3bb4583c1b69 57520-0514 HUMAN OTC DRUG Skin Relief Plus Aloe socotrina, Phosphorus, Silicea, Sulphur, LIQUID ORAL 20100722 UNAPPROVED HOMEOPATHIC Apotheca Company ALOE; PHOSPHORUS; SILICON DIOXIDE; SULFUR 200; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0515_a5b1bb8b-ae6e-41ad-b263-71b6a530a418 57520-0515 HUMAN OTC DRUG Menadione Menadione, LIQUID ORAL 20100616 UNAPPROVED HOMEOPATHIC Apotheca Company MENADIONE 30 [hp_C]/mL N 20181231 57520-0521_fc668c11-b2c5-40a0-90cc-8cc5a9f7cdac 57520-0521 HUMAN OTC DRUG Ear Inflammation Plus Belladonna, Conium maculatum, Dulcamara, LIQUID ORAL 20100624 UNAPPROVED HOMEOPATHIC Apotheca Company ATROPA BELLADONNA; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; CALCIUM SULFIDE; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SILICON DIOXIDE; MATRICARIA RECUTITA 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 57520-0522_a1565ba4-68aa-47e0-bcba-b8f9f8d934e7 57520-0522 HUMAN OTC DRUG Allersode II Allium cepa, Ambrosia artemisiaefolia, Euphrasia officinalis LIQUID ORAL 20100625 UNAPPROVED HOMEOPATHIC Apotheca Company ONION; AMBROSIA ARTEMISIIFOLIA; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED; SUS SCROFA ADRENAL GLAND; PORK LIVER; HISTAMINE DIHYDROCHLORIDE; ARSENIC TRIOXIDE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; PLATANUS OCCIDENTALIS POLLEN; FAGUS GRANDIFOLIA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES POLLEN; BETULA OCCIDENTALIS POLLEN; QUERCUS RUBRA POLLEN; CARYA OVATA POLLEN; POA PRATENSIS; DACTYLIS GLOMERATA; AGROSTIS GIGANTEA; PHLEUM PRATENSE; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN 3; 3; 3; 6; 24; 24; 30; 12; 12; 12; 12; 26; 26; 26; 26; 26; 26; 26; 26; 26; 26; 26; 26; 26; 26; 26; 26; 26; 26; 26; 26; 26 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0525_bd1417f6-cac5-44e0-bafb-5eb0d74c08bd 57520-0525 HUMAN OTC DRUG Diathesis IV Fel tauri, Ginkgo biloba, Kidney, Germanium sesquioxide, Argentum metallicum, Cuprum metallicum, Cysteinum, Aurum metallicum, Manganum gluconicum, Alpha-ketoglutaricum Acidum, Fumaricum Acidum, Mercurius solubilis, Natrum oxalate, Nux vomica, Phosphoricum acidum LIQUID ORAL 20110215 20190903 UNAPPROVED HOMEOPATHIC Apotheca Company GINKGO; PORK KIDNEY; GERMANIUM SESQUIOXIDE; SILVER; COPPER; GOLD; MANGANESE GLUCONATE; .ALPHA.-KETOGLUTARIC ACID; FUMARIC ACID; MERCURIUS SOLUBILIS; SODIUM OXALATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; CYSTEINE; BOS TAURUS BILE 6; 30; 8; 9; 9; 12; 10; 12; 12; 12; 12; 12; 12; 9; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0527_faaff7dd-1fa2-468b-8491-fa4269c77824 57520-0527 HUMAN OTC DRUG Endo Pure Testos (for Women) DNA, RNA, Sabal serrulata, Cortisol (hydrocortisone), Glandula suprarenalis, Hypothalamus, Pituitary, Testosterone, Chelidonium majus, Thuja occidentalis, LIQUID ORAL 20101210 UNAPPROVED HOMEOPATHIC Apotheca Company SAW PALMETTO; HYDROCORTISONE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; TESTOSTERONE; CHELIDONIUM MAJUS; THUJA OCCIDENTALIS LEAFY TWIG; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA 6; 6; 6; 6; 6; 6; 12; 12; 6; 6 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0528_02350e1d-ab21-4936-ada5-70235f810391 57520-0528 HUMAN OTC DRUG Infectistat Baptisia tinctoria, Echinacea, Hydrastis canadensis, Lobelia inflata, Lomatium, Phytolacca decandra, Symphytum officinale, Lung, Aconitum napellus, Arsenicum album, Belladonna, Bryonia, Causticum, LIQUID ORAL 20101210 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA; GOLDENSEAL; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; SUS SCROFA LUNG; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; RANCID BEEF 3; 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0529_c2f7f84e-5c5b-4869-978b-c3f5884d9779 57520-0529 HUMAN OTC DRUG Virotox WN Echinacea angustifolia, Hydrastis canadensis, Lomatium, Myrrha, Nasturtium aquaticum, Tabebuia impetiginosa, Glandula suprarenalis, Thymus LIQUID ORAL 20101207 UNAPPROVED HOMEOPATHIC Apotheca Company ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; MYRRH; RORIPPA NASTURTIUM-AQUATICUM; TABEBUIA IMPETIGINOSA BARK; SUS SCROFA ADRENAL GLAND; SUS SCROFA THYMUS; ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; RANCID BEEF; WEST NILE VIRUS 3; 3; 3; 3; 3; 3; 8; 8; 12; 12; 12; 12; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0535_55b09121-0798-4700-b235-eb213dcebce4 57520-0535 HUMAN OTC DRUG Liver Tonic I Carduus marianus, Chelidonium majus, Taraxacum officinale, Chionanthus virginica, Quassia amara, Hepar bovinum, LIQUID ORAL 20100714 UNAPPROVED HOMEOPATHIC Apotheca Company SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; TARAXACUM OFFICINALE; CHIONANTHUS VIRGINICUS BARK; QUASSIA AMARA WOOD; CEANOTHUS AMERICANUS LEAF; CITRULLUS COLOCYNTHIS FRUIT PULP; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; TEUCRIUM MARUM; BEEF LIVER; CULVER'S ROOT 1; 1; 1; 3; 3; 12; 12; 12; 12; 12; 12; 200; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0539_34fd3857-e3c4-4228-a2a7-a3dcdb229a40 57520-0539 HUMAN OTC DRUG Neuralgia HP Agaricus muscarius, Arnica montana, Hypericum perforatum, phosphorus, Plumbum metallicum, Mercurius solubilis, Allium cepa, Lycopodium clavatum, LIQUID ORAL 20100716 UNAPPROVED HOMEOPATHIC Apotheca Company AMANITA MUSCARIA VAR. MUSCARIA; ARNICA MONTANA; HYPERICUM PERFORATUM; PHOSPHORUS; LEAD; MERCURIUS SOLUBILIS; ONION; LYCOPODIUM CLAVATUM SPORE 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0544_04e17358-a418-4fdc-bf49-4519c221a896 57520-0544 HUMAN OTC DRUG Sciatica HP Aconitum napellus, Aesculus hippocastanum, Colchicum autumnale, Hypericum perforatum, Magnesia phosphorica, Plumbum metallicum, Rhus toxicodendron, Arnica Montana, LIQUID ORAL 20101210 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; HORSE CHESTNUT; COLCHICUM AUTUMNALE BULB; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; LEAD; TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 57520-0545_95e55a0d-8b14-4fe0-8396-012b5e9710b3 57520-0545 HUMAN OTC DRUG Hot Flash Rescue Capsicum annuum, Pulsatilla, Sanguinaria canadensis, SPRAY TOPICAL 20110607 UNAPPROVED HOMEOPATHIC Apotheca Company PAPRIKA; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0548_c28591f3-0488-4e74-814a-5f2486f68e27 57520-0548 HUMAN OTC DRUG NADH Plus Nadidum, Adenosinum cyclophosphoricum, Calcium D - pantothenate,Cholinum, Riboflavinum, Ubiquinone, Dimethyl glycine, SPRAY ORAL 20101007 UNAPPROVED HOMEOPATHIC Apotheca Company NADIDE; ADENOSINE CYCLIC 3',5'-PHOSPHATE; CALCIUM PANTOTHENATE; CHOLINE HYDROXIDE; RIBOFLAVIN; UBIDECARENONE; GLYCINE 4; 6; 6; 6; 6; 6; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0554_b57733ff-2d8f-4f11-9f6f-53b7fa684859 57520-0554 HUMAN OTC DRUG Chemsode Triticum aestivum, Glycyrrhiza glabra, Lappa major, Phytolacca decandra, Rhamnus purshiana, Trifolium pratense, Nitricum acidum, LIQUID ORAL 20100716 UNAPPROVED HOMEOPATHIC Apotheca Company WHEAT; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; FRANGULA PURSHIANA BARK; RED CLOVER; NITRIC ACID; PHOSPHORIC ACID; BOS TAURUS ADRENAL GLAND; BEEF LIVER; PORK KIDNEY; SUS SCROFA LYMPH; ATROPA BELLADONNA; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SALICYLIC ACID; CORTICOTROPIN; CORTISONE ACETATE; EUGENOL; STEARYL ALCOHOL; XYLITOL; ESTRONE; BENZOIC ACID; CHLORINE; POTASSIUM SORBATE; SORBITOL; RESORCINOL; BENZYL ALCOHOL; LACTIC ACID, DL-; ISOPROPYL PALMITATE; BORIC ACID; ACETIC ACID; PHENYLBUTAZONE; PETROLATUM; LEAD 1; 3; 3; 3; 3; 3; 12; 12; 8; 8; 8; 8; 12; 12; 12; 12; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0555_02b09574-b118-48d6-8900-f48641731e3d 57520-0555 HUMAN OTC DRUG Homeopathic HCG L-arginine, L-carnitine, L-ornithine, L-tyrosine, HCG(Human chorionic conadotropin, LIQUID ORAL 20100809 UNAPPROVED HOMEOPATHIC Apotheca Company ARGININE; LEVOCARNITINE HYDROCHLORIDE; ORNITHINE; TYROSINE; HUMAN CHORIONIC GONADOTROPIN 6; 6; 6; 6; 34 [hp_X]/mL; [hp_X]/mL; mL/mL; [hp_X]/mL; [hp_C]/mL N 20181231 57520-0556_8d2e5d3f-acba-45de-a296-d6fa7d157906 57520-0556 HUMAN OTC DRUG Compre Tox Eriodictyon californicum, Hamamelis virginiana, Nymphaea odorata, Plantago major, Xanthoxylum fraxineum, Xerophyllum asphodeloides, LIQUID ORAL 20101025 UNAPPROVED HOMEOPATHIC Apotheca Company ERIODICTYON CALIFORNICUM LEAF; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; NYMPHAEA ODORATA ROOT; PLANTAGO MAJOR; ZANTHOXYLUM AMERICANUM BARK; XEROPHYLLUM ASPHODELOIDES; YUCCA FILAMENTOSA; GINGER 3; 3; 3; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0563_aae392d0-2cae-4080-918b-1a00324cc605 57520-0563 HUMAN OTC DRUG Traumatone Calendula officinalis, Symphytum officinale, Staphysagria, Rhus Toxicodendron, Ruta Graveolens, Bellis perennis, LIQUID ORAL 20100722 UNAPPROVED HOMEOPATHIC Apotheca Company CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DELPHINIUM STAPHISAGRIA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; HYPERICUM PERFORATUM; STRONTIUM CARBONATE; PHOSPHORUS; ARNICA MONTANA 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0565_99854984-cdf9-429f-8131-058f952a3418 57520-0565 HUMAN OTC DRUG Sinuchron HP Arsenicum album, Hepar sulphuris calcareum, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum muriaticum, Phosphorus, Pulsatilla, Sepia, LIQUID ORAL 20101214 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0566_60a5a469-47a1-4f0c-8422-63793c651069 57520-0566 HUMAN OTC DRUG Ginkgo Tonic Aralia quinquefolia, Ginkgo biloba, Hydrocotyle asiatica, Polygonum multiflorum, Aronia melanocarpa, Vaccinium myrtillus, Germanium sesquioxide, Aurum metallicum Baryta muriatica, LIQUID ORAL 20101220 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; GINKGO; CENTELLA ASIATICA; FALLOPIA MULTIFLORA ROOT; ARONIA MELANOCARPA FRUIT; BILBERRY; GERMANIUM SESQUIOXIDE; GOLD; BARIUM CHLORIDE DIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; LEAD; CLAVICEPS PURPUREA SCLEROTIUM; TOBACCO LEAF; VISCUM ALBUM FRUITING TOP; UBIDECARENONE; ADENOSINE TRIPHOSPHATE 1; 1; 1; 1; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0570_b383c68a-73dc-480b-9841-86e4b01bb0c9 57520-0570 HUMAN OTC DRUG Rescue Cherry plum, Clematis, Impatiens, Rock Rose, Star of bethlehem, LIQUID ORAL 20110103 UNAPPROVED HOMEOPATHIC Apotheca Company PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; ORNITHOGALUM UMBELLATUM 200; 200; 200; 200; 200 [hp_M]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0571_2ac8ed04-3819-43c4-a911-d81b57d5713c 57520-0571 HUMAN OTC DRUG Fngsode Ceanothus americanus, Condurango, Echinacea angustifolia, Hydrastis canadensis, Ligusticum porteri, Lomatium, Nasturtium aquaticum, Tabebuia impetiginosa, Astragalus membranaceus, LIQUID ORAL 20101221 UNAPPROVED HOMEOPATHIC Apotheca Company CEANOTHUS AMERICANUS LEAF; MARSDENIA CONDURANGO BARK; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; RORIPPA NASTURTIUM-AQUATICUM; TABEBUIA IMPETIGINOSA BARK; ASTRAGALUS PROPINQUUS ROOT; SODIUM BORATE; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SUS SCROFA ADRENAL GLAND; PORK KIDNEY; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; CANDIDA ALBICANS; LIGUSTICUM PORTERI ROOT; PROPOLIS WAX 1; 3; 3; 3; 3; 3; 6; 6; 12; 8; 8; 60; 60; 12; 12; 12; 100; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0572_4debf365-33de-46eb-9bac-c417d88e5e5c 57520-0572 HUMAN OTC DRUG Adrenal Tincture Chelidonium majus, Echinacea, Glandula suprarenalis bovinum, Spleen, Carduus marianus, Natrum mutiaticum, Phosphoricum acidum, LIQUID ORAL 20101229 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; ECHINACEA; BOS TAURUS ADRENAL GLAND; BOS TAURUS SPLEEN; SILYBUM MARIANUM SEED; SODIUM CHLORIDE; PHOSPHORIC ACID 3; 3; 24; 24; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0576_35870313-82bc-4e30-9fb1-32e79281e216 57520-0576 HUMAN OTC DRUG Dr L Advanced HCG Formula Chromium GTF, Hypothalamus, Human chorionic gonadotropin, Garcinia cambogia, LIQUID ORAL 20110215 UNAPPROVED HOMEOPATHIC Apotheca Company CHROMIUM PICOLINATE; SUS SCROFA HYPOTHALAMUS; HUMAN CHORIONIC GONADOTROPIN; GARCINIA CAMBOGIA FRUIT 13; 13; 34; 34 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0581_d859bf73-bf70-44d6-90c6-457cd7d6b317 57520-0581 HUMAN OTC DRUG Sciatica Relief Capsicum annuum, Colocynthis, Gnaphalium polycephalum, Magnesia phosphorica, TABLET ORAL 20110317 UNAPPROVED HOMEOPATHIC Apotheca Company CAPSICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0582_4a3b8e30-239b-4bea-9166-ac421a6f4f26 57520-0582 HUMAN OTC DRUG Fibromyalgia Relief Aconitum napellus, Arsenicum album, Belladonna, Coniinum, Gelsemium sempervirens, Hypericum perforatum, Kali bichromicum, Lacticum acidum, Phosphoricum acidum, Rhus toxicodendrom, Uricum acidum, TABLET ORAL 20110607 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CONIINE; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM DICHROMATE; LACTIC ACID, DL-; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF; URIC ACID 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 57520-0584_82bb6e5a-f784-4e2d-9a46-37838b48fb20 57520-0584 HUMAN OTC DRUG Back and Neck Rescue Hypericum perforatum, Phytolacca decandra, Guaiacum, Ledum palustre, Conium maculatum, GEL TOPICAL 20110608 UNAPPROVED HOMEOPATHIC Apotheca Company HYPERICUM PERFORATUM; PHYTOLACCA AMERICANA ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; CONIUM MACULATUM FLOWERING TOP 3; 3; 6; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0595_d3471a2c-00f3-40a1-9109-d01c83d1ab6b 57520-0595 HUMAN OTC DRUG Water X Betula pendula, cortex, Lappa major, Plantago major, Taraxacum officinale, CAPSULE ORAL 20110125 UNAPPROVED HOMEOPATHIC Apotheca Company BETULA PENDULA BARK; ARCTIUM LAPPA ROOT; PLANTAGO MAJOR; TARAXACUM OFFICINALE 4; 4; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0596_90e5f238-3926-4ea7-b8fd-b89a3a81fe80 57520-0596 HUMAN OTC DRUG Lymphdrainex Geranium robertianum, Nasturtium aquaticum, Aloe socotrina, Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Apis mellifica, Equisetum hyemale, LIQUID ORAL 20110131 UNAPPROVED HOMEOPATHIC Apotheca Company GERANIUM ROBERTIANUM; RORIPPA NASTURTIUM-AQUATICUM; ALOE; JUGLANS REGIA FLOWERING TOP; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; VERONICA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; SARSAPARILLA ROOT; BARIUM CARBONATE; CALCIUM SULFIDE; MERCURIC CYANIDE; FERROUS IODIDE; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYROID; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS 4; 4; 12; 6; 6; 6; 6; 4; 4; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0597_7b959a05-514f-43b3-aa9a-4d145837d3d2 57520-0597 HUMAN OTC DRUG Lymphdrainex Geranium robertianum, Nasturtium aquaticum, Aloe socotrina, Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Apis mellifica, Equisetum hyemale, Fumaria officinalis, Natrum s LIQUID ORAL 20110131 UNAPPROVED HOMEOPATHIC Apotheca Company GERANIUM ROBERTIANUM; RORIPPA NASTURTIUM-AQUATICUM; ALOE; JUGLANS REGIA FLOWERING TOP; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; VERONICA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; SARSAPARILLA ROOT; BARIUM CARBONATE; CALCIUM SULFIDE; MERCURIC CYANIDE; FERROUS IODIDE; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID 4; 4; 12; 6; 6; 6; 6; 4; 4; 4; 4; 4; 4; 4; 5; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0598_cce09d45-8564-4996-b701-c5d282a8873b 57520-0598 HUMAN OTC DRUG VestalCare Spot Free Psoriasis Calcarea silicata, Lithium carbonicum, Natrum muriaticum, Phytolacca decandra, Sarsaparilla, Sulphur iodatum, Thyroidinum, TABLET ORAL 20110225 UNAPPROVED HOMEOPATHIC Apotheca Company CALCIUM SILICATE; LITHIUM CARBONATE; SODIUM CHLORIDE; PHYTOLACCA AMERICANA ROOT; SARSAPARILLA ROOT; SULFUR IODIDE; THYROID 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0603_ff7fae0c-1a0f-4798-9fc9-4e132e771936 57520-0603 HUMAN OTC DRUG Colic Beta vulgaris, Carduus marianus, Lappa major, Aluminium metallicum, Arsenicum album, Chelidonium majus, Hydrastis canadensis, Lycopodium clavatum, Natrum sulphuricum, Nux vomica, Phosphorus, LIQUID ORAL 20110128 UNAPPROVED HOMEOPATHIC Apotheca Company BETA VULGARIS; SILYBUM MARIANUM SEED; ARCTIUM LAPPA ROOT; ALUMINUM; ARSENIC TRIOXIDE; CHELIDONIUM MAJUS; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0604_8daf924a-3671-4cfa-b445-566946429aa9 57520-0604 HUMAN OTC DRUG HGH Hepar, Human growth hormone, Pituitarum, LIQUID ORAL 20110217 UNAPPROVED HOMEOPATHIC Apotheca Company PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0608_3219ad04-cd61-4407-8c0e-6fb22b7fbe5b 57520-0608 HUMAN OTC DRUG Homeopathic HCG Formula Cyanocobalamin, L-carnitine, Ornithine, Human chorionic gonadotropin, LIQUID ORAL 20110217 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; LEVOCARNITINE; ORNITHINE; HUMAN CHORIONIC GONADOTROPIN 6; 30; 30; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0609_d3d6a880-92a5-4ee4-84f7-0f177e2b9873 57520-0609 HUMAN OTC DRUG hCG Formula Foeniculum vulgare, Fucus vesiculosus, Lecithin, Ammonium carbonicum, Caulophyllum thalictroides, Galium aparine, Lac defloratum, Phosphorus, Phytolacca decandra, Rubus idaeus, SPRAY ORAL 20110208 UNAPPROVED HOMEOPATHIC Apotheca Company FENNEL SEED; FUCUS VESICULOSUS; LECITHIN, SOYBEAN; AMMONIUM CARBONATE; CAULOPHYLLUM THALICTROIDES ROOT; GALIUM APARINE; SKIM MILK; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; RUBUS IDAEUS LEAF; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CHLORIDE DIHYDRATE; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SUS SCROFA THYMUS; SUS SCROFA THYROID; AMMONIUM BROMIDE; ANTIMONY TRISULFIDE; MANGANESE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; SILICON DIOXIDE; HUMAN CHORIONIC GONADOTROPIN; CALCIUM ARSENATE 2; 3; 3; 6; 6; 6; 6; 6; 6; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 8; 8; 8; 30; 30; 30; 60; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0610_cf562505-3afe-4c59-8775-2d9c347167fc 57520-0610 HUMAN OTC DRUG Leg Cramp Relief Magnesia phosphorica, Cuprum metallicum, Colocynthis, Phytolacca decandra, Veratrum album, Causticum, Stannum metallicum, Rhus toxicodendron, TABLET ORAL 20110223 UNAPPROVED HOMEOPATHIC Apotheca Company MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; COPPER; CITRULLUS COLOCYNTHIS FRUIT PULP; PHYTOLACCA AMERICANA ROOT; VERATRUM ALBUM ROOT; TIN; TOXICODENDRON PUBESCENS LEAF; CAUSTICUM 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0611_627969d3-a40e-4e97-8fbe-5f03cb3fba83 57520-0611 HUMAN OTC DRUG Insomnia Plus Arsenicum album, Coffea cruda, Kali carbonicum, Magnesia carbonica, Nux vomica, Passiflora incarnata, Sepia, Valeriana officinalis, LIQUID ORAL 20110610 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; ARABICA COFFEE BEAN; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA TOP; SEPIA OFFICINALIS JUICE; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0613_6ebf13ac-b700-4e1c-900e-5eedfb680db6 57520-0613 HUMAN OTC DRUG Metabolism Berberis vulgaris, Glycyrrhiza glabra, Lappa major, Rhamnus purshiana, Trifolium pratense, Xanthoxylum fraxineum, Ascorbic acid, Cyanocobalamin, Riboflavinum, Thiaminum hydrochloricum, German sesquioxide, LIQUID ORAL 20110610 20180426 UNAPPROVED HOMEOPATHIC Apotheca Company BERBERIS VULGARIS FRUIT; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; FRANGULA PURSHIANA BARK; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ASCORBIC ACID; CYANOCOBALAMIN; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; GERMANIUM SESQUIOXIDE; CYSTEINE; MANGANESE GLUCONATE; ADENOSINE TRIPHOSPHATE; .ALPHA.-KETOGLUTARIC ACID; FUMARIC ACID; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; PYRUVIC ACID; UBIDECARENONE; CALCIUM SULFIDE 3; 3; 3; 3; 3; 3; 6; 6; 6; 6; 8; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0615_ef9158a2-df6c-4c03-9909-b524a0bdc12b 57520-0615 HUMAN OTC DRUG Nicotinum Nicotinum, LIQUID ORAL 20110317 UNAPPROVED HOMEOPATHIC Apotheca Company NICOTINE 6 [hp_X]/mL N 20181231 57520-0618_62c3e794-4421-4bc1-8b72-3ad9eefa26c8 57520-0618 HUMAN OTC DRUG Back and Neck Rescue Hypericum perforatum, Phytolacca decandra, Guaiacum, Ledum palustre, Conium maculatum, GEL TOPICAL 20111021 UNAPPROVED HOMEOPATHIC Apotheca Company HYPERICUM PERFORATUM; PHYTOLACCA AMERICANA ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; CONIUM MACULATUM FLOWERING TOP 3; 3; 6; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0621_49621ee7-1b8f-421d-9ac2-423f9bcabda6 57520-0621 HUMAN OTC DRUG Tendon Rescue Bryonia , Ruta graveolens, Bellis perennis, Argentum metallicum, GEL TOPICAL 20111024 UNAPPROVED HOMEOPATHIC Apotheca Company BRYONIA ALBA ROOT; RUTA GRAVEOLENS FLOWERING TOP; BELLIS PERENNIS; SILVER 3; 3; 6; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0628_e311bbb1-0dde-4d27-9c34-0403e00ed085 57520-0628 HUMAN OTC DRUG Muscle Ice Phytolacca decandra, Symphytum officinale, Bellis perennis, Ledum palustre, Ruta graveolens, Magnesia phosphorica, Silicea, GEL TOPICAL 20111024 UNAPPROVED HOMEOPATHIC Apotheca Company PHYTOLACCA AMERICANA ROOT; COMFREY ROOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SILICON DIOXIDE 1; 3; 6; 6; 6; 9; 9 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0630_01c74b2c-525e-44aa-bbd3-68a0ce135c64 57520-0630 HUMAN OTC DRUG Arnica Plus Arnica montana, Hamamelis virginiana, Rhus toxicodendron, GEL TOPICAL 20111020 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0635_30989d1c-fcdc-4e59-a243-e48886c6ecd2 57520-0635 HUMAN OTC DRUG Leg Cramp Relief Causticum, Colocynthis, Cuprum metallicum, Magnesia phosphorica, Phytolacca decandra, Rhus toxicodendron, Stannum metallicum, Veratrum album, TABLET ORAL 20110606 UNAPPROVED HOMEOPATHIC Apotheca Company CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; TIN; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0637_da8e0b11-fa2d-4a48-a916-e92ca61aea26 57520-0637 HUMAN OTC DRUG Endopure Testos for Men DNA, RNA, Cortisol, Glandula suprarenalis, Hypothalamus, Pituitary, Prostate, Testosterone, Chelidonium majus, Sabal serrulata, Thuja occidentalis, LIQUID ORAL 20110316 UNAPPROVED HOMEOPATHIC Apotheca Company HYDROCORTISONE; SUS SCROFA ADRENAL GLAND; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA PROSTATE; TESTOSTERONE; CHELIDONIUM MAJUS; SAW PALMETTO; THUJA OCCIDENTALIS LEAFY TWIG; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA 6; 6; 6; 6; 6; 12; 12; 12; 30; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0638_d23d7d2c-5a16-43b6-afd6-985b54cbc3f0 57520-0638 HUMAN OTC DRUG Testosterone Testosterone, TABLET ORAL 20110607 UNAPPROVED HOMEOPATHIC Apotheca Company TESTOSTERONE 30 [hp_X]/1 N 20181231 57520-0639_14864dd4-c0a1-4ab8-a9b2-348d36fd5309 57520-0639 HUMAN OTC DRUG Dr Cs Weight Maintenance Chelidonium majus, Fucus vesiculosus, Cyanocobalamin, Spongia tosta, Thea sinensis, Calcarea phosphorica, Calcarea fluorica, Kali phosphoricum, Natrum sulphuricum, Pulsatilla, Lycopodium clavatum, Cal LIQUID ORAL 20110715 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; FUCUS VESICULOSUS; CYANOCOBALAMIN; SPONGIA OFFICINALIS SKELETON, ROASTED; TEA LEAF OIL; TRIBASIC CALCIUM PHOSPHATE; CALCIUM FLUORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; PULSATILLA VULGARIS; LYCOPODIUM CLAVATUM SPORE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; SULFUR 6; 6; 6; 6; 8; 12; 12; 12; 12; 12; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0643_3cb092b0-440a-43bb-ac0c-9aa272b8540f 57520-0643 HUMAN OTC DRUG Rescue 5 Cherry plum, Clematis, Impatiens, Rock rose, Star of bethlehem, LIQUID ORAL 20110302 UNAPPROVED HOMEOPATHIC Apotheca Company PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; ORNITHOGALUM UMBELLATUM 30; 30; 30; 30; 30 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0644_d8e0ad5f-2735-4737-8b8d-4386fc3eeda9 57520-0644 HUMAN OTC DRUG Renstat Berberis vulgaris, Uva ursi, Sabal serrulata, Petroselinum sativum, Cantharis, Mercurius corrosivus, Solidago virgaurea, Sarsaparilla, Lithium carbonicum, Pareire brava, LIQUID ORAL 20110302 UNAPPROVED HOMEOPATHIC Apotheca Company BERBERIS VULGARIS ROOT BARK; ARCTOSTAPHYLOS UVA-URSI LEAF; SAW PALMETTO; PETROSELINUM CRISPUM; LYTTA VESICATORIA; MERCURIC CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SARSAPARILLA ROOT; LITHIUM CARBONATE; CHONDRODENDRON TOMENTOSUM ROOT 3; 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0645_eaac4da6-2987-4d11-92e7-b37f578b0797 57520-0645 HUMAN OTC DRUG Platinum for Men Cyanocobalamin, Glandula suprarenalis suis, Kali carbonicum, L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tyrosine, Orchitinum. LIQUID ORAL 20110303 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; SUS SCROFA ADRENAL GLAND; POTASSIUM CARBONATE; CARNITINE; GLUTAMINE; ORNITHINE; TRYPTOPHAN; TYROSINE; SUS SCROFA TESTICLE; SUS SCROFA THYROID; LYCOPODIUM CLAVATUM SPORE; HUMAN CHORIONIC GONADOTROPIN 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 10; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0646_d5abf2e7-2d35-405c-8e6a-f20fe1c5a867 57520-0646 HUMAN OTC DRUG Gold L-carnitine, L-glutamine, L-ornithine, L-tryptophan, L-tyrosine, Human chorionic gonadotropin, LIQUID ORAL 20110303 UNAPPROVED HOMEOPATHIC Apotheca Company CARNITINE; GLUTAMINE; ORNITHINE; TRYPTOPHAN; TYROSINE; HUMAN CHORIONIC GONADOTROPIN 6; 6; 6; 6; 6; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0647_cff86752-795b-479e-bb47-212a2e09654a 57520-0647 HUMAN OTC DRUG Platinum for Women Cyanocobalamin, Glandula suprarenalis suis, Kali carbonicum, L-carnitine, L-glutamine, L -ornithine, L-tryptophan, L-tyrosine, LIQUID ORAL 20110307 UNAPPROVED HOMEOPATHIC Apotheca Company CYANOCOBALAMIN; SUS SCROFA ADRENAL GLAND; POTASSIUM CARBONATE; LEVOCARNITINE; GLUTAMINE; ORNITHINE; TRYPTOPHAN; TYROSINE; SUS SCROFA OVARY; SUS SCROFA THYROID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; HUMAN CHORIONIC GONADOTROPIN 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 12; 60 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0648_9da92979-e839-4eee-a1f6-5038bde81461 57520-0648 HUMAN OTC DRUG Triple Potency HGH Hepar, Human growth hormone, Pituitarum, SPRAY ORAL 20110329 UNAPPROVED HOMEOPATHIC Apotheca Company SOMATROPIN; PORK LIVER; SUS SCROFA PITUITARY GLAND 30; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0651_f60c267a-5ed2-445d-a920-53d9a133204f 57520-0651 HUMAN OTC DRUG Allergy Rescue 1 Allium cepa, Ambrosia artemisiaefolia, Apis mellifica, Arsenicum album, Euphrasia officinalis, Nux vomica, Phosphorus, Pulsatilla, Solidago virgaurea, Sulphur, LIQUID ORAL 20110407 UNAPPROVED HOMEOPATHIC Apotheca Company ONION; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0652_ad3559fd-b3d6-4ecb-a88e-5bf112abbe50 57520-0652 HUMAN OTC DRUG Allergy Rescue 2 Chelidonium majus, Echinacea, Gentiana lutea, Arsenicum album, Carbo vegetalilis, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla, LIQUID ORAL 20110330 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; ECHINACEA; GENTIANA LUTEA ROOT; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0653_71f8568e-8431-4cea-9a60-fe32f5d458fa 57520-0653 HUMAN OTC DRUG Allergy Rescue 3 Baptisia tinctoria, Echinacea, Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Euphrasia officinalis, Natrum sulphuricum, Nux vomica, Phosphorus, Pulsatilla, Solidago virgaurea, Sulphur, LIQUID ORAL 20110331 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA; ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; EUPHRASIA STRICTA; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0654_782a5fd1-1b9d-462e-9317-0a793ee77128 57520-0654 HUMAN OTC DRUG Sinus Rescue 1 Arsenicum album, Hepar sulphuris calcareum, Hydrastis canadensis, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum muriaticum, Phosphorus, Pulsatilla, Sepia, Thuja occidentalis, LIQUID ORAL 20110331 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0655_0e0802ba-ab8e-4349-a180-95461c427ade 57520-0655 HUMAN OTC DRUG Sinus Rescue 2 Echinacea, Hydrastis canadensis, Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Kali bichromicum, Nux moschata, Pulsatilla, Sepia, Solidago virgaurea, LIQUID ORAL 20110330 UNAPPROVED HOMEOPATHIC Apotheca Company ECHINACEA; GOLDENSEAL; ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; POTASSIUM DICHROMATE; NUTMEG; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0656_06ba3f44-3685-40aa-b49d-a9164613e832 57520-0656 HUMAN OTC DRUG Bacteriostat Baptisia tinctoria, Echinacea, Phytolacca decandra, Aconitum napellus, Arsenicum album, Belladonna, Ferrum phosphoricum, Lachesis mutus, Phosphorus, LIQUID ORAL 20110330 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA; PHYTOLACCA AMERICANA ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; FERRUM PHOSPHORICUM; LACHESIS MUTA VENOM; PHOSPHORUS 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0657_a9a21507-d564-4f36-8745-63e77f473978 57520-0657 HUMAN OTC DRUG Virostat Echinacea, Hydrastis canadensis, Lomatium, Aconitum napellus, Arsenicum album, Belladonna, Eupatorium perfoliatum, Gelsemium sempervirens, Lachesis mutus, Rhus toxicodendron, Pyrogenium, LIQUID ORAL 20110330 UNAPPROVED HOMEOPATHIC Apotheca Company ECHINACEA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; TOXICODENDRON PUBESCENS LEAF; RANCID BEEF 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0659_f7082951-8818-47f2-ab7e-c88844135757 57520-0659 HUMAN OTC DRUG Bio Cherry Plum Cherry plum, LIQUID ORAL 20110316 UNAPPROVED HOMEOPATHIC Apotheca Company PRUNUS CERASIFERA FLOWER 200 [hp_C]/mL N 20181231 57520-0661_e1f6cec1-6bf3-40e0-8f60-21b370b10dce 57520-0661 HUMAN OTC DRUG Flu Rescue Baptisia tinctoria, Echinacea, Hydrastis canadensis, Phytolacca decandra, Arsenicum album, Bryonia, Eupatorium perfoliatum, Ferrum phosphoricum, LIQUID ORAL 20110405 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0662_3f451e6f-56ce-49fa-bd5f-f415d8970608 57520-0662 HUMAN OTC DRUG Infect Rescue Aconitum napellus, Arsenicum album, Baptisia tinctoria, Belladonna, Bryonia, Causticum, Echinacea, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Hydrastis canadensis, LIQUID ORAL 20110401 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAUSTICUM; ECHINACEA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; SODIUM SULFATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; COMFREY ROOT; DEFIBROTIDE (BOVINE LUNG) 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0663_401b45b7-2f40-43fe-970d-96c5842f4f43 57520-0663 HUMAN OTC DRUG Flutone Baptisia tinctoria, Echinacea, Hydrastis canadensis, Phytolacca decandra, Arsenicum album, Bryonia, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Ipecacuanha, Rhus toxicodendron LIQUID ORAL 20110318 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; TOXICODENDRON PUBESCENS LEAF 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0675_85627e48-e2ff-4a16-a5a5-44320a259b40 57520-0675 HUMAN OTC DRUG Virustat Echinacea, Hydrastit canadensis, Lomatium, Aconitum napellus, Arsenicum album, Belladonna, Eupatorium perfoliatum, Gelsemium sempervirens, Lachesis mutus, Rhus toxicodendron, Pyrogenium, LIQUID ORAL 20110413 UNAPPROVED HOMEOPATHIC Apotheca Company ECHINACEA; GOLDENSEAL; LOMATIUM DISSECTUM ROOT; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; TOXICODENDRON PUBESCENS LEAF; RANCID BEEF 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0676_ad79bd54-bfdf-4856-9c26-c0ae1987f29a 57520-0676 HUMAN OTC DRUG Fucus Vesiculosus Fucus vesiculosus, LIQUID ORAL 20110411 UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS 30 [hp_C]/mL N 20181231 57520-0677_90582206-0a8e-421e-9c1c-364461540168 57520-0677 HUMAN OTC DRUG Cesium Chloride Cesium chloride LIQUID ORAL 20110414 UNAPPROVED HOMEOPATHIC Apotheca Company CESIUM CHLORIDE 6 [hp_X]/mL N 20181231 57520-0684_c23d41be-892e-4002-90e2-2d65798b8c7f 57520-0684 HUMAN OTC DRUG Grippe HP Aconitum napellus, Arsenicum album, Baptisia tinctoris, Belladonna, Bryonia, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, LIQUID ORAL 20110428 UNAPPROVED HOMEOPATHIC Apotheca Company ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0702_f156f510-b1e8-4be5-b135-e5573fbe86f0 57520-0702 HUMAN OTC DRUG Trauma Free Symphytum officinale, Bellis perennis, Hypericum perforatum, Magnesia phosphorica, Ruta graveolens, Arnica montana, LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Apotheca Company COMFREY ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA 3; 12; 12; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0705_b9df1e34-aee7-4406-9da3-ecb9d28bd937 57520-0705 HUMAN OTC DRUG Sycosis Complex Zincum metallicum, Silicea, Sulphur, Thuja occidentalis, LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC Apotheca Company ZINC; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0710_51a649b9-ef27-4816-a50a-982233340909 57520-0710 HUMAN OTC DRUG Acne Kali bromatum, Natrum bromatum, Niccolum sulphuricum, Sulphur, Hepar suphuris calcareum, TABLET ORAL 20110715 UNAPPROVED HOMEOPATHIC Apotheca Company POTASSIUM BROMIDE; SODIUM BROMIDE; NICKEL SULFATE HEXAHYDRATE; SULFUR; CALCIUM SULFIDE 1; 2; 6; 6; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0711_eda9f5bc-1a20-4591-b1c1-3b015952c8db 57520-0711 HUMAN OTC DRUG Acne Kali bromatum, Natrum bromatum, Niccolum sulphuricum, Sulphur, Hepar sulphurs calcareum, TABLET ORAL 20110629 UNAPPROVED HOMEOPATHIC Apotheca Company POTASSIUM BROMIDE; SODIUM BROMIDE; NICKEL SULFATE HEXAHYDRATE; SULFUR; CALCIUM SULFIDE 1; 2; 6; 6; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57520-0712_4cefb645-9980-44f7-8e11-794448d38366 57520-0712 HUMAN OTC DRUG Loma Lux Psoriasis Kali bromatum, Natrum sulphuricum, Niccolum Sulphuricum, Kali sulphuricum, Zincum bromatum, LIQUID ORAL 20110705 UNAPPROVED HOMEOPATHIC Apotheca Company POTASSIUM BROMIDE; SODIUM BROMIDE; NICKEL SULFATE HEXAHYDRATE; POTASSIUM SULFATE; ZINC BROMIDE 1; 2; 3; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0713_a4b3c89c-c5f6-4ca7-ad45-72942c86e512 57520-0713 HUMAN OTC DRUG Loma Lux Psoriasis Kali bromatum, Natrum bromatum, Niccolum sulphuricum, Kali sulphuricum, Zincum bromatum, LIQUID ORAL 20110707 UNAPPROVED HOMEOPATHIC Apotheca Company POTASSIUM BROMIDE; SODIUM BROMIDE; NICKEL SULFATE HEXAHYDRATE; POTASSIUM SULFATE; ZINC BROMIDE 1; 2; 3; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0726_adfd6a4d-79b0-4264-aeec-8782ca97f4c0 57520-0726 HUMAN OTC DRUG Ileocecal Valve Support Iodium, Pituitarium posterium, Thyroidinum, Glandula suprarenalis suis, Fel tauri, Taraxacum officinale, Bryonia, Carbo vegetabilis, Colocynthis, Indolum, Lycopodium clavatum, Mercurius corrosivus, Nux vomica, Phosphorus, Pulsatilla, LIQUID ORAL 20110706 UNAPPROVED HOMEOPATHIC Apotheca Company IODINE; THYROID, PORCINE; SUS SCROFA ADRENAL GLAND; BOS TAURUS BILE; TARAXACUM OFFICINALE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; CITRULLUS COLOCYNTHIS FRUIT PULP; INDOLE; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SUS SCROFA PITUITARY GLAND 6; 8; 10; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 57520-0729_6f1a558c-d67c-431a-81aa-cdcaa4770f59 57520-0729 HUMAN OTC DRUG Melatonin Melatonin, LIQUID ORAL 20110715 UNAPPROVED HOMEOPATHIC Apotheca Company MELATONIN 200 [hp_C]/mL N 20181231 57520-0740_ff8259f7-2cc1-4467-8f9b-57af2da0b69b 57520-0740 HUMAN OTC DRUG DNA DNA, LIQUID ORAL 20110801 UNAPPROVED HOMEOPATHIC Apotheca Company HERRING SPERM DNA 12 [hp_X]/mL N 20181231 57520-0757_84e65868-3a28-446a-9caf-dc8c781a4d39 57520-0757 HUMAN OTC DRUG Lymph Rx Ceanothus Americanus, Euphrasia Officinalis, Germanium Robertianum, LIQUID ORAL 20110912 UNAPPROVED HOMEOPATHIC Apotheca Company CEANOTHUS AMERICANUS LEAF; EUPHRASIA STRICTA; GERANIUM ROBERTIANUM; JUGLANS REGIA FLOWERING TOP; MYOSOTIS ARVENSIS; SMILAX REGELII ROOT; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; ALTHAEA OFFICINALIS ROOT; PEUMUS BOLDUS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; FUMARIA OFFICINALIS FLOWERING TOP; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; POTASSIUM IODIDE; ECHINACEA, UNSPECIFIED; RORIPPA NASTURTIUM-AQUATICUM; VISCUM ALBUM FRUITING TOP; PHYTOLACCA AMERICANA ROOT; CAPSICUM; VERONICA OFFICINALIS FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; SODIUM SULFATE; BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFIDE; FERROUS IODIDE; MERCURIC CYANIDE; ARANEUS DIADEMATUS; SUS SCROFA PARATHYROID GLAND; SUS SCROFA THYMUS; THYROID, PORCINE 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 3; 3; 3; 3; 4; 4; 4; 4; 8; 8; 8; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0758_48379cba-deac-4a16-aee7-47c91edde5c2 57520-0758 HUMAN OTC DRUG Weed Grass Antigens Allium cepa, Arsenicum album, Nux vomica, Pulsatilla, Alfalfa, Amaranthus, Bamboo, Cocklebur, Dandelion, Goldenrod, Kentucky blue, Lambs quarters, LIQUID ORAL 20110817 UNAPPROVED HOMEOPATHIC Apotheca Company ALLIUM CEPA WHOLE; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; ALFALFA; AMARANTHUS PALMERI POLLEN; BAMBUSA VULGARIS LEAF; AGRIMONIA EUPATORIA FLOWERING TOP; TARAXACUM OFFICINALE; SOLIDAGO CANADENSIS FLOWERING TOP; POA PRATENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA POLLEN; FESTUCA PRATENSIS POLLEN; ARTEMISIA VULGARIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; RED CLOVER; AGROSTIS GIGANTEA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; ARTEMISIA TRIDENTATA POLLEN; AMARANTHUS SPINOSUS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA PSILOSTACHYA POLLEN; TRIFOLIUM REPENS FLOWER; RUMEX CRISPUS POLLEN; IVA ANGUSTIFOLIA POLLEN; OXALIS MONTANA LEAF 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0764_60bb8396-c03c-4e68-a189-eab00e7d5a38 57520-0764 HUMAN OTC DRUG Rheumatic Tonic Ginkgo biloba, Dioscorea villosa, Glycyrrhiza glabra, Viscum album, Pinus sylvestris, Apis mellifica, Dulcamara, Kalmia latifolia, Lycopodium clavatum, Sulphur, LIQUID ORAL 20110819 UNAPPROVED HOMEOPATHIC Apotheca Company GINKGO; DIOSCOREA VILLOSA ROOT; GLYCYRRHIZA GLABRA; VISCUM ALBUM FRUITING TOP; PINUS SYLVESTRIS FLOWERING TOP; APIS MELLIFERA; SOLANUM DULCAMARA FLOWER; KALMIA LATIFOLIA LEAF; LYCOPODIUM CLAVATUM SPORE; SULFUR 1; 1; 3; 3; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0777_fb927e05-fec0-4e00-878f-a3f8a215deaf 57520-0777 HUMAN OTC DRUG Itchy Gone Apis mellifica, Belladonna, Calcarea carbonica, Medusa, Mezereum, Rhus toxicodendron, Astacus fluviatilis, Chloralum, GEL TOPICAL 20110928 UNAPPROVED HOMEOPATHIC Apotheca Company APIS MELLIFERA; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; ASTACUS ASTACUS; CHLORAL HYDRATE; PHYSALIA PHYSALIS 12; 12; 12; 12; 12; 15; 15; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57520-0778_cec776b6-2985-4543-85f3-df3abb402851 57520-0778 HUMAN OTC DRUG Hemorrhoid Care Hamamelis virginiana, Aesculus hippocastanum, Aloe socotrina, Paeonia officinalis, Ignatia amara, Lycopodium clavatum, Nitricum acidum, Nux vomica, Phosphorus, Podophyllum peltatum, Pulsatilla, Sulphu GEL TOPICAL 20111108 UNAPPROVED HOMEOPATHIC Apotheca Company HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; ALOE; PAEONIA OFFICINALIS ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS; SULFUR; KRAMERIA LAPPACEA ROOT; CHELIDONIUM MAJUS 1; 1; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g N 20181231 57520-0787_205cd186-8a66-457d-86a1-10061666b427 57520-0787 HUMAN OTC DRUG Biological Complex II Anthracinum, LIQUID ORAL 20110826 UNAPPROVED HOMEOPATHIC Apotheca Company BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 30 [hp_C]/mL N 20181231 57520-0846_0f6228d9-da6d-45a2-9325-7129d443fa67 57520-0846 HUMAN OTC DRUG Bio Wild Rose Wild rose, LIQUID ORAL 20111104 20190903 UNAPPROVED HOMEOPATHIC Apotheca Company ROSA CANINA FLOWER 6 [hp_X]/mL N 20181231 57520-0870_482ee5fb-cdfb-46c7-b431-a1e1e58d21f0 57520-0870 HUMAN OTC DRUG Infectistat Baptisia tinctoria, Echinacea, Hydrastis canadensis, LIQUID ORAL 20110926 UNAPPROVED HOMEOPATHIC Apotheca Company BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL; LOBELIA INFLATA; LOMATIUM DISSECTUM ROOT; COMFREY ROOT; PHYTOLACCA AMERICANA ROOT; SUS SCROFA LUNG; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAUSTICUM; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM SULFATE; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; RANCID BEEF 3; 3; 3; 3; 3; 3; 3; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0908_9a735933-1eaa-4a78-81f8-22f4fcac3c37 57520-0908 HUMAN OTC DRUG Detox II Solidago virgaurea, Baptisia tinctoria, Berberis vulgaris, Equisetum hyemale, Argentum nitricum, Cantharis, Capsicum annuum, Cuprum sulphuricum, Orthosiphon stamineus, Pareira brava, Sarsaparilla, Ter LIQUID ORAL 20111004 UNAPPROVED HOMEOPATHIC Apotheca Company SOLIDAGO VIRGAUREA FLOWERING TOP; BAPTISIA TINCTORIA; BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; SILVER NITRATE; LYTTA VESICATORIA; CAPSICUM; CUPRIC SULFATE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; TURPENTINE; APIS MELLIFERA VENOM; AGATHOSMA BETULINA LEAF; MERCURIC CHLORIDE; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; GLYOXAL TRIMER DIHYDRATE; CALCIUM SULFIDE; SODIUM PYRUVATE; QUERCETIN; ESCHERICHIA COLI; SHIGELLA DYSENTERIAE 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 57520-0920_d9f9a9c8-0aa1-4a37-b3f9-fc6474ec120f 57520-0920 HUMAN OTC DRUG Influenza Remedy Eucalyptus globulus, Ipecacuanha, Aconitum napellus, LIQUID ORAL 20111025 UNAPPROVED HOMEOPATHIC Apotheca Company EUCALYPTUS GLOBULUS LEAF; IPECAC; ACONITUM NAPELLUS 2; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0923_e4adbd51-6b8c-4405-9eb2-8c7d6305071b 57520-0923 HUMAN OTC DRUG Stomach Spleen Meridian Opener Arsenicum album, Calcarea carbonica, Carduus marianus, Ceanothus americanus, Cinchona officinalis, Digitalis purpurea, Ignatia amara, Kali bichromicum, Lycopodium clavatum, LIQUID ORAL 20110930 UNAPPROVED HOMEOPATHIC Apotheca Company ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILYBUM MARIANUM SEED; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; DIGITALIS; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; LEAD; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; VERATRUM VIRIDE ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0925_825c6ade-d54a-494e-a305-5f32a7b791e4 57520-0925 HUMAN OTC DRUG Arthritis Joints Gnaphalium polycephalum, Berberis vulgaris, Cimicifuga racemosa, Cinchona officinalis, Colocynthis, Ledum palustre, Ranunculus bulbosus, Aesculus hippocastanum, Borax, Cuprum aceticum, Kali carbonicum LIQUID ORAL 20111024 UNAPPROVED HOMEOPATHIC Apotheca Company PSEUDOGNAPHALIUM OBTUSIFOLIUM; BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; SODIUM BORATE; CUPRIC ACETATE; POTASSIUM CARBONATE; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM; AMMONIUM CHLORIDE; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA ADRENAL GLAND; MERCURIC OXIDE, YELLOW; SEPIA OFFICINALIS JUICE; ZINC; PALLADIUM; TRINITROPHENOL; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA BONE MARROW 3; 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 8; 8; 10; 10; 10; 10; 10; 10; 12; 12; 30; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0934_44d92995-4a29-4eef-8817-f04cf56454a9 57520-0934 HUMAN OTC DRUG Joint Pain Arnica montana, Bryonia, Causticum, Rhus toxicodendron, Ferrum phosphoricum, LIQUID ORAL 20111102 UNAPPROVED HOMEOPATHIC Apotheca Company ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM; TOXICODENDRON PUBESCENS LEAF; FERRUM PHOSPHORICUM 4; 4; 4; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0942_58dd0037-1bc9-4420-941b-95d9c544d5c8 57520-0942 HUMAN OTC DRUG Petrochemical Detox Chelidonium majus, Symphytum officinale, Taraxacum officinale, Trifolium pratense, Acetone, Sodium triphosphate, Propylene glycol, Sodium benzene sulfonate, Ammonium muriaticum, Sodium lauryl sulfate, LIQUID ORAL 20111111 UNAPPROVED HOMEOPATHIC Apotheca Company CHELIDONIUM MAJUS; COMFREY ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; ACETONE; SODIUM TRIPOLYPHOSPHATE; PROPYLENE GLYCOL; BENZENESULFONIC ACID; AMMONIUM CHLORIDE; SODIUM LAURYL SULFATE; TURPENTINE; ARSENIC TRIOXIDE; CADMIUM SULFIDE; GELSEMIUM SEMPERVIRENS ROOT; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORIC ACID; PLATINUM; LATRODECTUS MACTANS 3; 3; 3; 3; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0951_4a3c0be7-b711-44d3-ae8e-6d936fa51e45 57520-0951 HUMAN OTC DRUG Gyno Complex Viburnum opulus, Magnesia phosphorica, Folliculinum, Pulsatilla, Borax, Mercurius solubilis, Nitricum acidum, Silicea, Thuja occidentalis, LIQUID ORAL 20111116 UNAPPROVED HOMEOPATHIC Apotheca Company VIBURNUM OPULUS BARK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ESTRONE; PULSATILLA VULGARIS; SODIUM BORATE; MERCURIUS SOLUBILIS; NITRIC ACID; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 3; 8; 12; 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0954_7dd4de79-5475-440b-b78e-4514f95e7a27 57520-0954 HUMAN OTC DRUG Seafood Antigens Codfish, Flounder, Halibut, Mackerel, Tuna, Clam, Crab, Oyster, Scallops, Shrimp, Belladonna, Carbo animalis, Colocynthis, Kali Carbonicum, Lycopodium clavatum, Pulsatilla, LIQUID ORAL 20111117 UNAPPROVED HOMEOPATHIC Apotheca Company COD, UNSPECIFIED; EUROPEAN FLOUNDER; ATLANTIC HALIBUT; SCOMBEROMORUS CAVALLA WHOLE; TUNA, UNSPECIFIED; QUAHOG, UNSPECIFIED; SHRIMP, UNSPECIFIED; BLUE CRAB; EDIBLE OYSTER; SEA SCALLOP; ATROPA BELLADONNA; CARBO ANIMALIS; CITRULLUS COLOCYNTHIS FRUIT PULP; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0955_a9321767-d9f4-4625-88a8-fd9dcf8b04ee 57520-0955 HUMAN OTC DRUG Bio Heather Heather, LIQUID ORAL 20111114 UNAPPROVED HOMEOPATHIC Apotheca Company CALLUNA VULGARIS FLOWERING TOP 6 [hp_X]/mL N 20181231 57520-0963_2ae98ffc-bb42-41c5-a155-6fe3b866b264 57520-0963 HUMAN OTC DRUG Lung Large Intestine Meridian Opener Aloe socotrina, Alumina, Apis mellifica, Arsenicum album, Baryta carbonica, Bryonia, Carbo vegetabilis, Chamomilla, Kali bichromicum, Phosphorus, Plumbum metallicum, Pyrogenium, Sulphur, LIQUID ORAL 20111118 UNAPPROVED HOMEOPATHIC Apotheca Company ALOE; ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; POTASSIUM DICHROMATE; PHOSPHORUS; LEAD; RANCID BEEF; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0964_4ac1767c-9e35-4343-a632-320ffbd195ed 57520-0964 HUMAN OTC DRUG Metab Ascorbicum acidum, Cysteinum, Manganum gluconate, Alpha-ketoglutaricum acidum, Fumaricum acidum, Germanium sesquioxide, Iodium, Magnesium metallicum, Natrum oxalaceticum, Pulsatilla, Thyroidinum suis, LIQUID ORAL 20111116 UNAPPROVED HOMEOPATHIC Apotheca Company ASCORBIC ACID; CYSTEINE; MANGANESE GLUCONATE; .ALPHA.-KETOGLUTARIC ACID; FUMARIC ACID; GERMANIUM SESQUIOXIDE; IODINE; MAGNESIUM; SODIUM DIETHYL OXALACETATE; PULSATILLA VULGARIS; THYROID, PORCINE; VANADIUM 6; 9; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0968_9de0e652-63cc-4131-958b-cf6f232d0e99 57520-0968 HUMAN OTC DRUG Thyropar Fucus vesiculosus, Spongia tosta, Glandula suprarenalis suis, Pituitaria glandula suis, Thyroidinum suis, Bromium, Calcarea carbonica, Iodium, Lachesis mutus, Pulsatilla, LIQUID ORAL 20111121 UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; LACHESIS MUTA VENOM; PULSATILLA VULGARIS 3; 3; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0969_e564cf7e-22c4-4642-a9f7-93ff250a7696 57520-0969 HUMAN OTC DRUG E.O.L. Cholesterinum, Stillingia sylvatica, Zincum gluconicum, Thiaminum hydrochloricum, 5-hydroxytryptophan, Betain HCL, Biotin, Cholinum CoQ10, Dl-methionine, L-alanine, L-cysteine, L-cystine, L-glutamic a LIQUID ORAL 20111229 UNAPPROVED HOMEOPATHIC Apotheca Company CHOLESTEROL; STILLINGIA SYLVATICA ROOT; ZINC GLUCONATE; THIAMINE HYDROCHLORIDE; OXITRIPTAN; BETAINE HYDROCHLORIDE; BIOTIN; CHOLINE HYDROXIDE; UBIDECARENONE; RACEMETHIONINE; ALANINE; CYSTEINE; CYSTINE; GLUTAMIC ACID; METHIONINE; SERINE; LYSINE; AMINOBENZOIC ACID; POTASSIUM GLUCONATE; SUS SCROFA THYMUS; THYROID, PORCINE; CHOLECALCIFEROL; COPPER; SELENIUM; SELENIUM DIOXIDE; MALUS SYLVESTRIS FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER 3; 3; 3; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-0985_438193f3-a608-4152-ab85-645fe58047de 57520-0985 HUMAN OTC DRUG Thyropar Fucus vesiculosus, Spongia tosta, Glandula suprarenalis suis, Pituitaria glandula suis, Thyroidinum suis, Bromium, Calcarea carbonica, Iodium, Lachesis mutus, Pulsatilla, LIQUID ORAL 20111122 UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; LACHESIS MUTA VENOM; PULSATILLA VULGARIS 3; 3; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0994_f4805ff4-1849-4036-921b-a5296aabe446 57520-0994 HUMAN OTC DRUG Hypothalmu Stim Aralia quinquefolia, Ginkgo biloba, Hydrocotyle asiatica, Brain, Hypothalamus, Pituitaria glandula, Phosphorus, Silicea, LIQUID ORAL 20111202 UNAPPROVED HOMEOPATHIC Apotheca Company AMERICAN GINSENG; GINKGO; CENTELLA ASIATICA; PORK BRAIN; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; PHOSPHORUS; SILICON DIOXIDE 3; 3; 3; 6; 6; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-0998_1872216c-6977-4246-b8e3-13d9a77b70af 57520-0998 HUMAN OTC DRUG Anpitua Stim Adrenocorticotrophin, Agnus castus, Baryta carbonica, Calcarea carbonica, Iodium, Lac caninum, Natrum muriaticum, Phosphoricum acidum, Sepia, Thyroidinum suis, LIQUID ORAL 20111205 UNAPPROVED HOMEOPATHIC Apotheca Company CORTICOTROPIN; CHASTE TREE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; CANIS LUPUS FAMILIARIS MILK; SODIUM CHLORIDE; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE; THYROID, PORCINE 6; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-1001_15438445-fcd3-4ce7-a6ad-f88d9102bda8 57520-1001 HUMAN OTC DRUG Coumarin Coumarinum, LIQUID ORAL 20111215 UNAPPROVED HOMEOPATHIC Apotheca Company COUMARIN 6 [hp_X]/mL N 20181231 57520-1002_14c1a052-2969-4337-b161-0115860db155 57520-1002 HUMAN OTC DRUG Piperine Piperine, LIQUID ORAL 20111215 UNAPPROVED HOMEOPATHIC Apotheca Company PIPERINE 6 [hp_X]/mL N 20181231 57520-1003_44d3e789-8dd8-4679-9dc4-9f3371c7e1a0 57520-1003 HUMAN OTC DRUG Quercetin Quercetin, LIQUID ORAL 20111216 UNAPPROVED HOMEOPATHIC Apotheca Company QUERCETIN 6 [hp_X]/mL N 20181231 57520-1021_0cafdd55-113c-4e74-a2d9-025a12bbf555 57520-1021 HUMAN OTC DRUG Apiol Apiolum, LIQUID ORAL 20111213 UNAPPROVED HOMEOPATHIC Apotheca Company APIOLE (PARSLEY) 6 [hp_X]/mL N 20181231 57520-1038_9b81bf47-67ca-41a0-b699-31c5243723e3 57520-1038 HUMAN OTC DRUG Neuro II Hydrastis canadensis, Taraxacum officinale, Acetylcholine chloride, Adrenalinum, Gaba, Histaminum hydrochloricum, Norepinephrine, Tyramine, LIQUID ORAL 20120116 UNAPPROVED HOMEOPATHIC Apotheca Company GOLDENSEAL; TARAXACUM OFFICINALE; ACETYLCHOLINE CHLORIDE; EPINEPHRINE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE DIHYDROCHLORIDE; NOREPINEPHRINE; TYRAMINE 3; 3; 6; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-1039_61736877-7215-416c-bca1-67bbedb38539 57520-1039 HUMAN OTC DRUG Phenylalanine Phenylalanine, LIQUID ORAL 20100130 UNAPPROVED HOMEOPATHIC Apotheca Company PHENYLALANINE 6 [hp_X]/mL N 20181231 57520-1041_af5e0622-2e07-49fc-aaca-801ee8c30110 57520-1041 HUMAN OTC DRUG Sore Throat Juglans regia, Myosotis arvensis, Scrophularia nodosa, Teucrium scorodonia, Veronica officinalis, Equisetum hyemale, Fumaria officinalis, Geranium robertianum, Nasturtium aquaticum, Natrum sulphuricum LIQUID ORAL 20120118 UNAPPROVED HOMEOPATHIC Apotheca Company JUGLANS REGIA FLOWERING TOP; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM; RORIPPA NASTURTIUM-AQUATICUM; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; ARANEUS DIADEMATUS; SMILAX REGELII ROOT; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; SUS SCROFA LYMPH; THYROID, PORCINE 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 5; 6; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-1047_00b153a6-4f36-464d-b9eb-9cf0a07829f4 57520-1047 HUMAN OTC DRUG Dr. Pearsalls 500 Calorie Diet Protocol Drops Fucus vesiculosus, Cyanocobalamin, Glandula suprarenalis suis, Hepar suis, L-carnitine, L-ornithine, Antimonium crudum, Thyroidinum suis, Natrum sulphuricum, Pancreatinum, Hypothalamus (suis), LIQUID ORAL 20120202 UNAPPROVED HOMEOPATHIC Apotheca Company FUCUS VESICULOSUS; CYANOCOBALAMIN; SUS SCROFA ADRENAL GLAND; PORK LIVER; LEVOCARNITINE; ORNITHINE; ANTIMONY TRISULFIDE; THYROID, PORCINE; SODIUM SULFATE; PANCRELIPASE; SUS SCROFA HYPOTHALAMUS 2; 6; 6; 6; 6; 6; 8; 8; 10; 12; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-1049_5e2a7e57-649e-46cf-897e-72e0a2e43894 57520-1049 HUMAN OTC DRUG Human Parvovirus Remedy Parvovirus LIQUID ORAL 20120208 UNAPPROVED HOMEOPATHIC Apotheca Company HUMAN PARVOVIRUS B19 15 [hp_X]/mL N 20181231 57520-1056_3a74036c-c863-4d01-937a-0b7894b306ce 57520-1056 HUMAN OTC DRUG Mentox HP Baryta carbonica, Calcarea carbonica, Lachesis mutus, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Phosphorus, LIQUID ORAL 20120120 UNAPPROVED HOMEOPATHIC Apotheca Company BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57520-1111_0a0329cb-24eb-4618-884a-efee16a5b1b5 57520-1111 HUMAN OTC DRUG H Acne Formula Calendula officinalis, Nux vomica, Silicea, OIL TOPICAL 20120313 UNAPPROVED HOMEOPATHIC Apotheca Company CALENDULA OFFICINALIS FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE 12; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 57520-1251_9f627670-07a7-409f-b440-1595e21550a9 57520-1251 HUMAN OTC DRUG Cough and Cold Relief Allium Cepa, Arsenicum Album, Ferrum Phosphoricum, Lac Caninum, Natrum Muriaticum, Nux Vomica TABLET ORAL 20130830 UNAPPROVED HOMEOPATHIC Apotheca Company ONION; ARSENIC TRIOXIDE; FERROSOFERRIC PHOSPHATE; CANIS LUPUS FAMILIARIS MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 57524-013_47dba2cd-a67e-468e-a073-b31ab7057f6e 57524-013 HUMAN OTC DRUG epHiderm Spot Treatment Salicylic Acid LOTION TOPICAL 20130110 OTC MONOGRAPH FINAL part358B KANTIAN SKINCARE, LLC SALICYLIC ACID 1 mg/g E 20171231 57524-014_617841d6-9c6d-4dbf-ba9b-2c652b8d6b82 57524-014 HUMAN OTC DRUG Neutralyze Spot Treatment Salicylic Acid GEL TOPICAL 20141103 OTC MONOGRAPH FINAL part358B KANTIAN SKINCARE, LLC SALICYLIC ACID 1 mg/g N 20181231 57525-020_638d5769-6346-a4d1-e053-2991aa0a769e 57525-020 HUMAN OTC DRUG RITUALS Miracle Foundation broad spectrum SPF 15 sunscreen Ivory OCTINOXATE, OXYBENZONE CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; OXYBENZONE 20; 1 mg/mL; mg/mL N 20191231 57525-025_638d86ab-9885-59ed-e053-2a91aa0a98ee 57525-025 HUMAN OTC DRUG RITUALS Miracle Foundation broad spectrum SPF 15 sunscreen Ivory Beige OCTINOXATE, OXYBENZONE CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; OXYBENZONE 20; 1 mg/mL; mg/mL N 20191231 57525-026_638d8438-b8b9-f97b-e053-2991aa0a7661 57525-026 HUMAN OTC DRUG RITUALS Miracle Foundation broad spectrum SPF 15 sunscreen Pink Beige OCTINOXATE, OXYBENZONE CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; OXYBENZONE 20; 1 mg/mL; mg/mL N 20191231 57525-027_638d8438-b909-f97b-e053-2991aa0a7661 57525-027 HUMAN OTC DRUG RITUALS Miracle Foundation broad spectrum SPF 15 sunscreen Beige Pink OCTINOXATE, OXYBENZONE CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; OXYBENZONE 20; 1 mg/mL; mg/mL N 20191231 57525-028_638d8438-b918-f97b-e053-2991aa0a7661 57525-028 HUMAN OTC DRUG RITUALS Miracle Foundation broad spectrum SPF 15 sunscreen Warm Beige OCTINOXATE, OXYBENZONE CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; OXYBENZONE 20; 1 mg/mL; mg/mL N 20191231 57525-029_638d8438-b929-f97b-e053-2991aa0a7661 57525-029 HUMAN OTC DRUG RITUALS Miracle Foundation broad spectrum SPF 15 sunscreen Golden Beige OCTINOXATE, OXYBENZONE CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; OXYBENZONE 20; 1 mg/mL; mg/mL N 20191231 57525-030_638d8438-b986-f97b-e053-2991aa0a7661 57525-030 HUMAN OTC DRUG RITUALS Miracle Foundation broad spectrum SPF 15 sunscreen Bronzing Beige OCTINOXATE, OXYBENZONE CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; OXYBENZONE 20; 1 mg/mL; mg/mL N 20191231 57525-031_638dbc25-480c-3d56-e053-2a91aa0a9554 57525-031 HUMAN OTC DRUG RITUALS Miracle Foundation broad spectrum SPF 15 sunscreen Mahogany OCTINOXATE, OXYBENZONE CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; OXYBENZONE 20; 1 mg/mL; mg/mL N 20191231 57525-032_638dac56-2284-251b-e053-2a91aa0a1e16 57525-032 HUMAN OTC DRUG RITUALS Miracle Foundation broad spectrum SPF 15 sunscreen Golden Honey OCTINOXATE, OXYBENZONE CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; OXYBENZONE 20; 1 mg/mL; mg/mL N 20191231 57525-033_638dbc25-4823-3d56-e053-2a91aa0a9554 57525-033 HUMAN OTC DRUG RITUALS Miracle Foundation broad spectrum SPF 15 sunscreen Warm Almond OCTINOXATE, OXYBENZONE CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; OXYBENZONE 20; 1 mg/mL; mg/mL N 20191231 57525-040_64194895-a371-a062-e053-2a91aa0a9ad4 57525-040 HUMAN OTC DRUG RITUALS Miracle Light Weight Foundation broad spectrum SPF 15 sunscreen. - Warm Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 24.2 mg/mL; mg/mL N 20191231 57525-041_641910a7-5e97-7170-e053-2a91aa0a0b6a 57525-041 HUMAN OTC DRUG RITUALS Miracle Light Weight Foundation broad spectrum SPF 15 sunscreen. - Warm OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 24.2 mg/mL; mg/mL N 20191231 57525-042_64197dc6-95a7-f840-e053-2a91aa0aea02 57525-042 HUMAN OTC DRUG RITUALS Miracle Light Weight Foundation broad spectrum SPF 15 sunscreen. - Pink Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 24.2 mg/mL; mg/mL N 20191231 57525-043_641917d3-ba6a-4b2b-e053-2a91aa0a3e18 57525-043 HUMAN OTC DRUG RITUALS Miracle Light Weight Foundation broad spectrum SPF 15 sunscreen. - Mahogany OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 24.2 mg/mL; mg/mL N 20191231 57525-044_64198af6-1e6a-4777-e053-2991aa0a8db6 57525-044 HUMAN OTC DRUG RITUALS Miracle Light Weight Foundation broad spectrum SPF 15 sunscreen. - Ivory OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 24.2 mg/mL; mg/mL N 20191231 57525-045_64197dc6-95b9-f840-e053-2a91aa0aea02 57525-045 HUMAN OTC DRUG RITUALS Miracle Light Weight Foundation broad spectrum SPF 15 sunscreen. - Ivory Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 24.2 mg/mL; mg/mL N 20191231 57525-046_64198af6-1e7c-4777-e053-2991aa0a8db6 57525-046 HUMAN OTC DRUG RITUALS Miracle Light Weight Foundation broad spectrum SPF 15 sunscreen. - Golden Honey OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 24.2 mg/mL; mg/mL N 20191231 57525-047_641910a7-5ea9-7170-e053-2a91aa0a0b6a 57525-047 HUMAN OTC DRUG RITUALS Miracle Light Weight Foundation broad spectrum SPF 15 sunscreen. - Golden Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 24.2 mg/mL; mg/mL N 20191231 57525-048_641910a7-5eb8-7170-e053-2a91aa0a0b6a 57525-048 HUMAN OTC DRUG RITUALS Miracle Light Weight Foundation broad spectrum SPF 15 sunscreen. - Bronzing Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 24.2 mg/mL; mg/mL N 20191231 57525-049_64197dc6-95bd-f840-e053-2a91aa0aea02 57525-049 HUMAN OTC DRUG RITUALS Miracle Light Weight Foundation broad spectrum SPF 15 sunscreen. - Beige Pink OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part352 Rituals Cosmetics USA, Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 24.2 mg/mL; mg/mL N 20191231 57538-003_88ad6c5f-5f8f-4e86-bf72-793fcc30f917 57538-003 HUMAN OTC DRUG AXE BRAND MEDICATED MENTHOL, CAMPHOR AND METHYL SALICYLATE OIL TOPICAL 20010413 OTC MONOGRAPH NOT FINAL part348 LEUNG KAI FOOK MEDICAL CO PTE LTD MENTHOL; CAMPHOR (SYNTHETIC); METHYL SALICYLATE 16; 5; 15 g/100mL; g/100mL; g/100mL N 20181231 57539-0221_460ea4ed-64ab-4fe2-aac2-6dca496a204d 57539-0221 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20111001 ANDA ANDA040911 Novocol Inc. LIDOCAINE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 57541-000_8e7480a9-2466-4a03-9bba-bdc56a8535f9 57541-000 HUMAN OTC DRUG Dr. OH PATCH CAMPHOR (NATURAL), MENTHOL SOLUTION TOPICAL 20130725 OTC MONOGRAPH NOT FINAL part348 Dr. Oh Patch Inc. CAMPHOR (NATURAL); MENTHOL 1.42; .8 mg/100mg; mg/100mg E 20171231 57544-180_7328bb5e-057f-47bb-bdf3-6684bb59fcac 57544-180 HUMAN OTC DRUG ProCure Hand Sanitizing ALCOHOL SWAB TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part333E TwinMed, LLC ALCOHOL 65.9 g/100g N 20181231 57554-110_2d49daa7-aa02-4219-880b-e1697bde8a7e 57554-110 HUMAN OTC DRUG DermaWound Wound Care povidone-iodine OINTMENT TOPICAL 20130408 OTC MONOGRAPH NOT FINAL part333A Wound Care USA, LLC POVIDONE-IODINE 10 g/100g E 20171231 57554-120_6221ba86-8b7f-48c8-8284-6950f9fc36b1 57554-120 HUMAN OTC DRUG DermaWound Wound Care Venous Stasis benzocaine hydrochloride OINTMENT TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part348 Wound Care USA, LLC BENZOCAINE 1.27 g/100g E 20171231 57554-210_75843d3f-3297-4658-a790-9715ed016cc0 57554-210 HUMAN OTC DRUG Mend19 Wound Care povidone-iodine OINTMENT TOPICAL 20130408 OTC MONOGRAPH NOT FINAL part333A Wound Care USA, LLC POVIDONE-IODINE 10 g/100g E 20171231 57554-220_5dea01fd-594b-4768-9308-057e8ae27660 57554-220 HUMAN OTC DRUG Mend19 Wound Care Venous Stasis benzocaine hydrochloride OINTMENT TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part348 Wound Care USA, LLC BENZOCAINE 1.27 g/100g E 20171231 57557-100_28af1500-9e59-4101-bc90-d6a7e4bb184e 57557-100 HUMAN OTC DRUG Othree 50 Whitening Titanium Dioxide, Zinc Oxide, Octinoxate, Octocrylene CREAM TOPICAL 20130403 OTC MONOGRAPH NOT FINAL part352 Cellab Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTOCRYLENE 3.936; 4; 6; 4.8 g/80g; g/80g; g/80g; g/80g N 20181231 57595-001_bfad4f43-3418-4a2a-9acf-483a688abbb0 57595-001 HUMAN OTC DRUG Sunsect Insect Repellent Sunscreen Octinoxate, oxybenzone, octisalate LOTION TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 Iguana LLC OCTISALATE; OCTINOXATE; OXYBENZONE; DIETHYLTOLUAMIDE 5; 7.5; 6; 20 g/100g; g/100g; g/100g; g/100g N 20181231 57597-043_602aeae0-6814-1f8e-e053-2a91aa0a2aae 57597-043 HUMAN OTC DRUG Wong To Yick External Analgesic Camphor Menthol Methyl Salicylate OIL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part348 Wong To Yick Wood Lock Ointment Ltd CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 1; 1.6; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 57598-888_3c25da76-6c97-4bac-9ce6-a0f0c340d4e5 57598-888 HUMAN OTC DRUG Ultra Balm Menthol and Methyl Salicylate OINTMENT TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 Ling Nam Medicine Factory (H.K.) Ltd. MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 140; 232 mg/g; mg/g N 20181231 57605-0001_f353b617-3ee9-4b95-aa43-b2c0674a808a 57605-0001 HUMAN OTC DRUG HGH Hepar Suis, Oleum Animale, Human Growth Hormone, Pituitaria Glandula LIQUID ORAL 20131017 20180821 UNAPPROVED HOMEOPATHIC 21st Century Designer Health Products PORK LIVER; CERVUS ELAPHUS HORN OIL; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57605-0002_f8605556-d9ce-4d74-8fd3-6b0e3b92c030 57605-0002 HUMAN OTC DRUG HGH (Original Formula) Hepar Suis, Human Growth Hormone, Pituitaria Glandula (suis) LIQUID ORAL 20140709 20190818 UNAPPROVED HOMEOPATHIC 21st Century Designer Health Products PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57605-0003_f46dd30f-ea92-4d63-8501-47d8c3de2fd6 57605-0003 HUMAN OTC DRUG HGH Hepar suis, Oleum animale, Human growth hormone, Pituitaria glandula (suis), SPRAY ORAL 20140416 20190522 UNAPPROVED HOMEOPATHIC 21st Century Designer Health Products PORK LIVER; CERVUS ELAPHUS HORN OIL; SOMATROPIN; SUS SCROFA PITUITARY GLAND 8; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57605-0004_56a06d16-80f3-4dee-92a5-f81a48a52fc9 57605-0004 HUMAN OTC DRUG Advanced Formula Hepar Suis, Oleum Animale, Human Growth Hormone, Pituitaria Glandula (Suis) LIQUID ORAL 20151211 20210323 UNAPPROVED HOMEOPATHIC 21st Century Designer Health Products PORK LIVER; CERVUS ELAPHUS HORN OIL; SOMATROPIN; SUS SCROFA PITUITARY GLAND 8; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57605-0005_a156df22-b330-478d-bfaf-5251b4f9dc81 57605-0005 HUMAN OTC DRUG Original Formula Hepar Suis, Human Growth Hormone, Hypophysis Suis SPRAY ORAL 20160427 UNAPPROVED HOMEOPATHIC Designer Health Products, LLC PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57605-0006_a6588383-c557-4101-a31f-5dd95a6505e2 57605-0006 HUMAN OTC DRUG Advanced Formula Hepar Suis, Oleum Animale, Human Growth Hormone, Hypophosis Suis LIQUID ORAL 20160714 UNAPPROVED HOMEOPATHIC Designer Health Products, LLC PORK LIVER; CERVUS ELAPHUS HORN OIL; SOMATROPIN; SUS SCROFA PITUITARY GLAND 8; 8; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57613-008_5fc46336-59ab-1837-e053-2991aa0a4a22 57613-008 HUMAN OTC DRUG Prevail One Step povidone-iodine and alcohol GEL TOPICAL 19970601 OTC MONOGRAPH NOT FINAL part333A Productos Urologos de Mexico, S.A. de C.V. POVIDONE-IODINE; ALCOHOL 5; .62 mg/mL; mL/mL N 20181231 57613-009_5fc44dec-0589-357a-e053-2a91aa0a6aae 57613-009 HUMAN OTC DRUG Prevail-FX One Step povidone-iodine and isopropyl alcohol SOLUTION TOPICAL 19980601 OTC MONOGRAPH NOT FINAL part333A Productos Urologos de Mexico, S.A. de C.V. POVIDONE-IODINE; ISOPROPYL ALCOHOL 8.3; 725 mg/mL; mg/mL N 20181231 57619-400_1daa86fa-4ead-1e90-e054-00144ff88e88 57619-400 HUMAN OTC DRUG Manzanilla Sophia Chamomile (Matricaria Chamomilla L.) SOLUTION/ DROPS OPHTHALMIC 20100412 UNAPPROVED HOMEOPATHIC LABORATORIOS SOPHIA, S.A. DE C.V. MATRICARIA RECUTITA 3 [hp_X]/mL N 20181231 57624-601_993d22e0-2d01-4c91-baef-fb4f0eded888 57624-601 HUMAN OTC DRUG Fresh N Up Benzalkonium chloride SOLUTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333A Rockline Industries, Inc BENZALKONIUM CHLORIDE .115 mL/100mL N 20181231 57627-100_6b9fc12c-4b8d-4fe3-8120-636ecfccbd83 57627-100 HUMAN OTC DRUG Clear Complexion Spot Treatment Merle Norman SALICYLIC ACID GEL TOPICAL 20110418 OTC MONOGRAPH FINAL part358H Merle Norman Cosmetics, Inc SALICYLIC ACID 1 g/100g N 20181231 57627-101_0ab3bce1-11e3-41dc-9878-0b82095754bd 57627-101 HUMAN OTC DRUG Clear Complexion Moisturizer Merle Norman salicylic Acid LOTION TOPICAL 20110418 OTC MONOGRAPH FINAL part358H Merle Norman Cosmetics, Inc SALICYLIC ACID 2 g/100g N 20181231 57627-102_f6e6f00f-e638-409d-a505-9ab5daac7730 57627-102 HUMAN OTC DRUG Clear Complexion Toner Merle Norman SALICYLIC ACID LOTION TOPICAL 20110418 OTC MONOGRAPH FINAL part358H Merle Norman Cosmetics, Inc SALICYLIC ACID .5 g/100mL N 20181231 57627-103_24ecb5a1-d76b-49a9-8f0f-a04977068cef 57627-103 HUMAN OTC DRUG Clear Complexion Cleanser Merle Norman Salicylic Acid GEL TOPICAL 20110419 OTC MONOGRAPH FINAL part333D Merle Norman Cosmetics, Inc SALICYLIC ACID 2 g/100g N 20181231 57627-107_3c150f29-9d8e-41e9-89b3-3159439167a9 57627-107 HUMAN OTC DRUG Lip Conditioner SPF 15 Merle Norman OCTINOXATE,OCTISALATE JELLY TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part352 Merle Norman OCTINOXATE; OCTISALATE .278; .185 g/3.7g; g/3.7g N 20181231 57627-108_2bc8b04e-5d18-44ee-b812-6988c7c2cd9c 57627-108 HUMAN OTC DRUG Foundation Primer Plus SPF 15 MERLE NORMAN octinoxate, octisalate CREAM TOPICAL 20110422 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics OCTINOXATE; OCTISALATE 2.63; 1.75 g/35g; g/35g N 20181231 57627-110_595f145a-b155-4beb-ba1a-3dcaedb1c34f 57627-110 HUMAN OTC DRUG Lasting Foundation SPF 12 Merle Norman TITANIUM DIOXIDE CREAM TOPICAL 20110422 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc TITANIUM DIOXIDE 2.4 g/30g N 20181231 57627-113_7cea5852-dc87-4c38-8adb-bb5b263489a1 57627-113 HUMAN OTC DRUG Flawless Effect Liquid Foundation SPF 15 Merle Norman OCTINOXATE, OXYBENZONE LIQUID TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part352 Merle Norman OXYBENZONE; OCTINOXATE .9; 2.25 g/30g; g/30g N 20181231 57627-115_40ef2014-88ce-4b0d-9e2c-fdfc0be386d1 57627-115 HUMAN OTC DRUG Timeless Age Defying SPF 20 Merle Norman OCTINOXATE, OXYBENZONE CREAM TOPICAL 20110505 OTC MONOGRAPH FINAL part352 Merle Norman OCTINOXATE; OXYBENZONE 2.25; .6 g/30mL; g/30mL N 20181231 57627-117_af0cc4f8-83a2-448e-9731-f536f8609d77 57627-117 HUMAN OTC DRUG Ultra Light Sunscreen Broad Spectrum SPF 50 Merle Norman Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20130329 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.39; 11.3; 5.65; 3.11; 6.78 g/113g; g/113g; g/113g; g/113g; g/113g N 20181231 57627-119_7b931dc7-20fb-4bd1-9b05-86a8ee1f41f4 57627-119 HUMAN OTC DRUG Preventage Firming Defense Normal/Oily Broad Spectrum SPF 15 Merle Norman Avobenzone, Octocrylene CREAM TOPICAL 20120815 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc AVOBENZONE; OCTOCRYLENE 1.064; 5.264 g/56g; g/56g N 20181231 57627-121_b2cb1bb7-6c6d-4a73-aca3-08e6345e2f71 57627-121 HUMAN OTC DRUG Preventage Firming Defense Creme Normal/Dry Merle Norman Avobenzone, Octocrylene CREAM TOPICAL 20120817 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc AVOBENZONE; OCTOCRYLENE 1.064; 5.264 g/56g; g/56g N 20181231 57627-123_bf5e3d64-5bae-417d-bca8-d74d2cd5ee17 57627-123 HUMAN OTC DRUG Bare Perfecting Makeup Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL N 20181231 57627-124_87729719-2af9-4d59-90c1-8247ff1553cd 57627-124 HUMAN OTC DRUG Vanilla Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL N 20181231 57627-125_2653870f-d6bd-487a-a085-3b345651a9fa 57627-125 HUMAN OTC DRUG Ivory Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL N 20181231 57627-126_7a7397ce-38ee-4397-acf7-d7fc87cafeb8 57627-126 HUMAN OTC DRUG Alabaster Perfecting Makeup SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL N 20181231 57627-127_4ff47f19-d766-4bfc-87c4-a6cc2d7ec6bc 57627-127 HUMAN OTC DRUG Merle Norman Alabaster Beige Perfecting Makeup SPF 25 octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL N 20181231 57627-128_24e954f1-7957-4f7b-be3d-f7ce3db450f7 57627-128 HUMAN OTC DRUG Creamy Beige Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL N 20181231 57627-129_ebb8e39d-3f20-4f8b-ae5a-70b931312a59 57627-129 HUMAN OTC DRUG Simply Beige Perfecting makeup SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 30; 30 g/30mL; g/30mL N 20181231 57627-130_f6df2988-8a22-4164-9aa3-d1b12c0ec5d5 57627-130 HUMAN OTC DRUG Soft Bisque Perfecting Makeup SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120826 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL N 20181231 57627-131_76d892d0-ed4c-48fd-9a3a-7f8b117726be 57627-131 HUMAN OTC DRUG Desert Beige Perfecting Makeup SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL N 20181231 57627-132_129c2bf3-8f98-44b0-84a0-5ccaf9094f6a 57627-132 HUMAN OTC DRUG Medium Deep Warm Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 7.5; 7.1 g/100mL; g/100mL N 20181231 57627-133_4c6be8d4-cce6-47ae-b97d-67fa8c048047 57627-133 HUMAN OTC DRUG Delicate Beige Perfecting Makeup SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL N 20181231 57627-134_ca5c3ed9-5807-4763-8f0c-11fd1f68fe7c 57627-134 HUMAN OTC DRUG Rich Almond Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate,Titanium dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL N 20181231 57627-135_ea0b5a31-760f-4ee4-946b-547e815c650d 57627-135 HUMAN OTC DRUG Warm Honey Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL N 20181231 57627-136_416ed825-b443-479f-b6d6-24ce5a03db5c 57627-136 HUMAN OTC DRUG Sun Beige Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 2.25; 2.13 g/30mL; g/30mL N 20181231 57627-137_738c92de-a78c-4607-bc31-eb02d8516b20 57627-137 HUMAN OTC DRUG Deep Tan Perfecting Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120822 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 75; 71 mg/mL; mg/mL N 20181231 57627-149_186ce415-bcd2-424e-ac7c-2b5a13759959 57627-149 HUMAN OTC DRUG Anti-Aging Complex SPF 30 Merle Norman Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone EMULSION TOPICAL 20121108 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .93; 2.48; 1.24; .729; 1.55 g/31g; g/31g; g/31g; g/31g; g/31g N 20181231 57627-150_d2cdf090-3e7a-41b1-a954-ce6104ba1008 57627-150 HUMAN OTC DRUG Anti-Aging Complex Eye Treatment Merle Norman Octinoxate, Zinc Oxide LOTION TOPICAL 20121109 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics OCTINOXATE; ZINC OXIDE 1.18; 1.04 g/16g; g/16g N 20181231 57627-151_48c2b544-bbdc-4a97-b702-bc9ce4a0bcbf 57627-151 HUMAN OTC DRUG Sheer Defense Tinted Moisturizer SPF 15 L10 Merle Norman Octinoxate, Titanium Dioxide LIQUID TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 5.12 g/100g; g/100g N 20181231 57627-152_9c153e22-e049-4d66-9f63-33bc8637c59b 57627-152 HUMAN OTC DRUG Sheer Defense Tinted Moisturizer SPF15 L20 Merle Norman Octinoxate, Titanium Dioxide LIQUID TOPICAL 20121207 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 5.02 g/100g; g/100g N 20181231 57627-153_a90f5d78-7e3d-465a-a1e4-35bc6bb31ea7 57627-153 HUMAN OTC DRUG Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 M50 Merle Norman Octinoxate, Titanium Dioxide LIQUID TOPICAL 20121210 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 4.19 g/100g; g/100g N 20181231 57627-154_226ff995-9045-41e0-9e20-d416c851f09a 57627-154 HUMAN OTC DRUG Sheer Defense Tinted Moisturizer Broad Spectrum SPF 15 MD 70 Merle Norman Octinoxate, Titanium Dioxide LIQUID TOPICAL 20121210 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 3.67 g/100g; g/100g N 20181231 57627-155_16f61bef-784b-43fb-9b3d-dd20e0f0b799 57627-155 HUMAN OTC DRUG Sheer Defense Tinted Moisturizer SPF 15 ML 30 Merle Norman Octinoxate, Titanium Dioxide LIQUID TOPICAL 20121211 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 4.79 g/100g; g/100g N 20181231 57627-156_b1ca93a7-c324-4681-b5a2-32ebf98bf216 57627-156 HUMAN OTC DRUG Sheer Defense Tinted Moisturizer SPF 15 ML 40 Merle Norman Octinoxate, Titanium Dioxide LIQUID TOPICAL 20121212 OTC MONOGRAPH NOT FINAL part352 Merle Norman Cosmetics, Inc. OCTINOXATE; TITANIUM DIOXIDE 2.6; 15.3 g/35g; g/35g N 20181231 57627-157_e6c18380-e515-4dc1-aa1e-762aadcf019b 57627-157 HUMAN OTC DRUG Bare Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g N 20181231 57627-158_998651f8-7190-4bca-bfec-4b39dd4c6622 57627-158 HUMAN OTC DRUG Preventage Hand Treatment Broad Spectrum SPF 15 Merle Norman Avobenzone, Octocrylene CREAM TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part352 Merle Norman AVOBENZONE; OCTOCRYLENE 1.9; 9.4 g/100g; g/100g N 20181231 57627-159_e6c18380-e515-4dc1-aa1e-762aadcf019b 57627-159 HUMAN OTC DRUG Porcelain Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g N 20181231 57627-160_e6c18380-e515-4dc1-aa1e-762aadcf019b 57627-160 HUMAN OTC DRUG Alabaster Beige Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g N 20181231 57627-161_e6c18380-e515-4dc1-aa1e-762aadcf019b 57627-161 HUMAN OTC DRUG Creamy Beige Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g N 20181231 57627-162_e6c18380-e515-4dc1-aa1e-762aadcf019b 57627-162 HUMAN OTC DRUG Simply Beige Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g N 20181231 57627-163_e6c18380-e515-4dc1-aa1e-762aadcf019b 57627-163 HUMAN OTC DRUG Soft Bisque Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g N 20181231 57627-164_e6c18380-e515-4dc1-aa1e-762aadcf019b 57627-164 HUMAN OTC DRUG Sand Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g N 20181231 57627-165_e6c18380-e515-4dc1-aa1e-762aadcf019b 57627-165 HUMAN OTC DRUG Medium Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g N 20181231 57627-166_e6c18380-e515-4dc1-aa1e-762aadcf019b 57627-166 HUMAN OTC DRUG Sandy Beige Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g N 20181231 57627-167_e6c18380-e515-4dc1-aa1e-762aadcf019b 57627-167 HUMAN OTC DRUG Delicate Beige Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g N 20181231 57627-168_e6c18380-e515-4dc1-aa1e-762aadcf019b 57627-168 HUMAN OTC DRUG Tan Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g N 20181231 57627-169_e6c18380-e515-4dc1-aa1e-762aadcf019b 57627-169 HUMAN OTC DRUG Ivory Expert Finish Makeup Broad Spectrum SPF 25 Merle Norman Octinoxate, Titanium Dioxide CREAM TOPICAL 20131020 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; TITANIUM DIOXIDE 4; 5.2 g/100g; g/100g N 20181231 57627-170_1c749316-0dae-424b-ad65-c49c0b6bde23 57627-170 HUMAN OTC DRUG CC Cream Broad Spectrum SPF 30 Merle Norman Homosalate, Octinoxate, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20140619 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics HOMOSALATE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7; 2.5; 2; 4.1 g/100g; g/100g; g/100g; g/100g N 20181231 57627-171_1ba5f838-2266-47b7-a6d3-117fea9de039 57627-171 HUMAN OTC DRUG Anti-Blemish Foundation Primer Acne Treatment Gel Merle Norman Salicylic Acid GEL TOPICAL 20140630 OTC MONOGRAPH FINAL part358H Merle Norman Cosmetics, Inc SALICYLIC ACID 2 g/100g N 20181231 57627-172_22bca5aa-6df6-42cc-991c-61c9c9f575d2 57627-172 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Light Beige Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-173_6c3fb838-3205-4f42-b777-58f6fb560086 57627-173 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Porcelain Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-174_eb741107-adfa-48aa-8efa-6f9cfc7c8790 57627-174 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Sesame Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-175_11b4f88f-d0c0-469e-8785-174dd48f1896 57627-175 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Ivory Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-176_493baebe-fa40-4728-a9da-8099312e86fb 57627-176 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Alabaster Beige Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-177_0aa50733-c159-401f-a43d-17a8fcfe2f4e 57627-177 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Alabaster Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-178_808a12fd-e226-4cac-905b-c26f3ad43725 57627-178 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Creamy Beige Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-179_ef8cd20d-dcc2-4a5e-90a0-29ba5b438599 57627-179 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Simply Beige Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-180_e5f94244-42c0-4ec5-8f1f-c310ce7164ff 57627-180 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Soft Bisque Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-181_6480e176-11a2-4382-acd6-68a6064e583d 57627-181 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Quiet Rose Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-182_c3e9443d-b2b1-42e0-843b-c86e8ef5db9c 57627-182 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Sandy Beige Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-183_0daf24ec-2374-430f-832f-3fd14ac7ba59 57627-183 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Pure Beige Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-184_be9a2c31-d617-446b-870e-f2b10c25885e 57627-184 HUMAN OTC DRUG Timeless Illuminating Makeup SPF 30 Rich Walnut Merle Norman Octinoxate, Oxybenzone CREAM TOPICAL 20170124 OTC MONOGRAPH FINAL part352 Merle Norman Cosmetics, Inc OCTINOXATE; OXYBENZONE 7.5; 2 g/100mL; g/100mL N 20181231 57627-200_bc063af7-2a04-4330-a236-5896c9156ec0 57627-200 HUMAN OTC DRUG Acne Defense Foaming Cleanser Merle Norman Salicylic Acid LIQUID TOPICAL 20170713 OTC MONOGRAPH FINAL part358H Merle Norman Cosmetics, Inc SALICYLIC ACID 2 g/100mL N 20181231 57627-201_f2dddfd5-6879-4801-a114-7a44bab3c57f 57627-201 HUMAN OTC DRUG Acne Defense Spot Treatment Merle Norman Salicylic Acid GEL TOPICAL 20170714 OTC MONOGRAPH FINAL part358H Merle Norman Cosmetics, Inc SALICYLIC ACID 2 g/100g N 20181231 57627-202_53042052-4a49-402b-be6b-cae7b3f9f184 57627-202 HUMAN OTC DRUG Acne defense Daily Treatment Serum Merle Norman Benzoyl Peroxide GEL TOPICAL 20170714 OTC MONOGRAPH FINAL part333D Merle Norman Cosmetics BENZOYL PEROXIDE 2.5 g/100g N 20181231 57629-200_ff2e44ed-2d0e-4cdf-891f-6ea191c28fc8 57629-200 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20110101 UNAPPROVED DRUG OTHER KMR Pharmaceuticals LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 57629-201_1147bea7-48b6-4350-92e5-43820e42a8d3 57629-201 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20110101 UNAPPROVED DRUG OTHER KMR Pharmaceuticals LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 57629-202_c5a5df65-dcdd-413c-9330-f4340e661dba 57629-202 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20110101 UNAPPROVED DRUG OTHER KMR Pharmaceuticals LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 57629-203_47d11463-77f4-40f3-828e-0fce65fee88d 57629-203 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20110101 UNAPPROVED DRUG OTHER KMR Pharmaceuticals LLC HYOSCYAMINE SULFATE .375 mg/1 E 20171231 57631-105_268b3084-7702-498e-926e-721e2c648b36 57631-105 HUMAN OTC DRUG Amrut Balm Menthol, Camphor OINTMENT TOPICAL 20170418 OTC MONOGRAPH NOT FINAL part348 InvaTech Pharma Solutions LLC MENTHOL; CAMPHOR (NATURAL) 3.7; .75 g/g; g/g N 20181231 57631-116_58034087-267e-42ef-896b-0907a097fa73 57631-116 HUMAN OTC DRUG Relexo Oil Menthol, Camphor OIL TOPICAL 20170228 OTC MONOGRAPH NOT FINAL part348 InvaTech Pharma Solutions LLC MENTHOL; CAMPHOR (NATURAL) 5; 2.5 1/mL; 1/mL N 20181231 57631-128_46fab49a-687a-4642-abfe-5fa43d70d60b 57631-128 HUMAN OTC DRUG Honey Ginger Cough Drops menthol LOZENGE ORAL 20171031 OTC MONOGRAPH FINAL part341 InvaTech Pharma Solutions LLC MENTHOL 3.18 mg/1 N 20181231 57631-129_aa16288c-c31d-434e-826b-88beaee25a72 57631-129 HUMAN OTC DRUG Honey Tulsi Cough Drops Menthol LOZENGE ORAL 20171101 OTC MONOGRAPH FINAL part341 InvaTech Pharma Solutions LLC MENTHOL 3.9 mg/1 N 20181231 57631-130_c9ae1bf6-8e6f-4697-8bcc-76e06a844301 57631-130 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20171031 OTC MONOGRAPH FINAL part341 InvaTech Pharma Solutions LLC MENTHOL 3.18 mg/1 N 20181231 57648-002_dedd48c5-e030-4214-9747-a55ad69af35a 57648-002 HUMAN OTC DRUG THE MAGIC BULLET Bisacodyl SUPPOSITORY RECTAL 20040101 OTC MONOGRAPH NOT FINAL part334 Concepts in Confidence BISACODYL 10 mg/1 N 20181231 57650-159_dfee0bad-f3e1-42d2-a932-89e3e9e90fd9 57650-159 HUMAN OTC DRUG Samhealthyskin B.B. SUNSCREEN BROAD SPECTRUM SPF 40 TITANIUM DIOXIDE CREAM TOPICAL 20130425 OTC MONOGRAPH NOT FINAL part352 Samhealthyskin.COM LLC TITANIUM DIOXIDE 100 mg/mL E 20171231 57660-000_2d03e606-2a98-58e5-e054-00144ff88e88 57660-000 HUMAN OTC DRUG PLAQUE HD ANTICAVITY FRESH MINT FLAVOR Professional Plaque-Identifying SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130610 OTC MONOGRAPH FINAL part355 TJA Health LLC SODIUM FLUORIDE .14 g/100g N 20181231 57660-001_2d0301d9-e9e4-655b-e054-00144ff8d46c 57660-001 HUMAN OTC DRUG PLAQUE HD ANTICAVITY BERRY BUBBLE GUM FLAVOR Professional Plaque-Identifying SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20140319 OTC MONOGRAPH FINAL part355 TJA Health LLC SODIUM FLUORIDE .14 g/100g N 20181231 57664-001_615671e8-85e9-4793-e053-2991aa0a79f9 57664-001 HUMAN PRESCRIPTION DRUG Pramipexole Pramipexole TABLET ORAL 20130523 20181228 ANDA ANDA091683 Caraco Pharmaceutical Laboratories, Ltd. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 57664-002_615671e8-85e9-4793-e053-2991aa0a79f9 57664-002 HUMAN PRESCRIPTION DRUG Pramipexole Pramipexole TABLET ORAL 20130523 20181228 ANDA ANDA091683 Caraco Pharmaceutical Laboratories, Ltd. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 57664-003_615671e8-85e9-4793-e053-2991aa0a79f9 57664-003 HUMAN PRESCRIPTION DRUG Pramipexole Pramipexole TABLET ORAL 20130523 20181228 ANDA ANDA091683 Caraco Pharmaceutical Laboratories, Ltd. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 57664-004_615671e8-85e9-4793-e053-2991aa0a79f9 57664-004 HUMAN PRESCRIPTION DRUG Pramipexole Pramipexole TABLET ORAL 20130523 20181228 ANDA ANDA091683 Caraco Pharmaceutical Laboratories, Ltd. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 57664-005_615671e8-85e9-4793-e053-2991aa0a79f9 57664-005 HUMAN PRESCRIPTION DRUG Pramipexole Pramipexole TABLET ORAL 20130523 20181228 ANDA ANDA091683 Caraco Pharmaceutical Laboratories, Ltd. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 57664-055_8858588a-91db-42f1-89fe-9a70b1bc369d 57664-055 HUMAN PRESCRIPTION DRUG Amlodipine Besylate AMLODIPINE BESYLATE TABLET ORAL 20121019 ANDA ANDA078552 Caraco Pharmaceutical Laboratories, Ltd. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 57664-056_8858588a-91db-42f1-89fe-9a70b1bc369d 57664-056 HUMAN PRESCRIPTION DRUG Amlodipine Besylate AMLODIPINE BESYLATE TABLET ORAL 20121019 ANDA ANDA078552 Caraco Pharmaceutical Laboratories, Ltd. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 57664-057_8858588a-91db-42f1-89fe-9a70b1bc369d 57664-057 HUMAN PRESCRIPTION DRUG Amlodipine Besylate AMLODIPINE BESYLATE TABLET ORAL 20121019 ANDA ANDA078552 Caraco Pharmaceutical Laboratories, Ltd. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 57664-070_bca6e06f-e9ea-4957-af87-453044fbf10b 57664-070 HUMAN OTC DRUG Ferrous Sulfate Ferrous Sulfate TABLET, FILM COATED ORAL 20140701 UNAPPROVED DRUG OTHER Sun Pharmaceutical Industries, Inc. FERROUS SULFATE 325 mg/1 N 20181231 57664-071_bca6e06f-e9ea-4957-af87-453044fbf10b 57664-071 HUMAN OTC DRUG Ferrous Sulfate Ferrous Sulfate TABLET, FILM COATED ORAL 20140701 UNAPPROVED DRUG OTHER Sun Pharmaceutical Industries, Inc. FERROUS SULFATE 325 mg/1 N 20181231 57664-102_5fc8dccb-c6eb-0b9a-e053-2a91aa0a7bad 57664-102 HUMAN PRESCRIPTION DRUG Hydrocodone bitartrate and ibuprofen Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20130528 ANDA ANDA091633 Sun Pharmaceutical Industries, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 57664-103_90813662-c27e-4541-86a5-70b435533b69 57664-103 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 19950401 UNAPPROVED DRUG OTHER Caraco Pharmaceutical Laboratories, Ltd. SALSALATE 500 mg/1 E 20171231 57664-105_90813662-c27e-4541-86a5-70b435533b69 57664-105 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 19950401 UNAPPROVED DRUG OTHER Caraco Pharmaceutical Laboratories, Ltd. SALSALATE 750 mg/1 E 20171231 57664-107_61563305-2f6b-e520-e053-2a91aa0a15c2 57664-107 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 Sun Pharmaceutical Industries, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 57664-108_61563305-2f6b-e520-e053-2a91aa0a15c2 57664-108 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 Sun Pharmaceutical Industries, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 57664-109_61563305-2f6b-e520-e053-2a91aa0a15c2 57664-109 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 Sun Pharmaceutical Industries, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 57664-112_f5bf497c-a72c-44b0-902b-44d11bbbad1c 57664-112 HUMAN PRESCRIPTION DRUG HydrOXYzine hydrochloride HydrOXYzine hydrochloride TABLET ORAL 20090331 ANDA ANDA040899 Caraco Pharmaceutical Laboratories, Ltd. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 57664-113_f5bf497c-a72c-44b0-902b-44d11bbbad1c 57664-113 HUMAN PRESCRIPTION DRUG HydrOXYzine hydrochloride HydrOXYzine hydrochloride TABLET ORAL 20090331 ANDA ANDA040899 Caraco Pharmaceutical Laboratories, Ltd. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 57664-114_f5bf497c-a72c-44b0-902b-44d11bbbad1c 57664-114 HUMAN PRESCRIPTION DRUG HydrOXYzine hydrochloride HydrOXYzine hydrochloride TABLET ORAL 20090331 ANDA ANDA040899 Caraco Pharmaceutical Laboratories, Ltd. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 57664-115_a818aeed-253b-44e7-b728-81837d284a53 57664-115 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET, FILM COATED ORAL 20090701 ANDA ANDA079239 Caraco Pharmaceutical Laboratories, Ltd. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 57664-116_a6298497-4039-4942-b4ba-f380597f0588 57664-116 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA090529 Sun Pharmaceutical Industries, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 57664-117_a6298497-4039-4942-b4ba-f380597f0588 57664-117 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA090529 Sun Pharmaceutical Industries, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 57664-118_a6298497-4039-4942-b4ba-f380597f0588 57664-118 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20120101 ANDA ANDA090529 Sun Pharmaceutical Industries, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 57664-119_45ad5425-58bc-46b3-8f6e-c01f4dd1d1e7 57664-119 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20130516 ANDA ANDA091401 Caraco Pharmaceutical Laboratories, Ltd. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 57664-120_45ad5425-58bc-46b3-8f6e-c01f4dd1d1e7 57664-120 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20130516 ANDA ANDA091401 Caraco Pharmaceutical Laboratories, Ltd. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 57664-124_98b9c198-0ac9-4b96-9cce-d042640610bb 57664-124 HUMAN PRESCRIPTION DRUG VALPROIC ACID Valproic Acid SOLUTION ORAL 20120418 ANDA ANDA090517 Caraco Pharmaceutical Laboratories, Ltd. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 57664-126_5d1a641b-b76d-39bc-e053-2991aa0a3b1d 57664-126 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Sun Pharmaceutical Industries, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 57664-133_c43bca62-1470-4723-83d0-348401fafde7 57664-133 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE ORAL 20080407 ANDA ANDA040587 Sun Pharmaceutical Industries, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 57664-134_c43bca62-1470-4723-83d0-348401fafde7 57664-134 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE ORAL 20080407 ANDA ANDA040587 Sun Pharmaceutical Industries, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 57664-135_b9f244e4-bf34-4f84-9507-4a56e21b8d8e 57664-135 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE ORAL 20070628 ANDA ANDA077067 Caraco Pharmaceutical Laboratories, Ltd. NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 57664-136_60b62e02-97c8-7ea2-e053-2a91aa0a6362 57664-136 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20091229 20180302 ANDA ANDA040865 Sun Pharmaceutical Industries, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 57664-155_26bd6fd5-7ec1-428d-aca5-a0de6604ad25 57664-155 HUMAN PRESCRIPTION DRUG oxycodone and acetaminophen oxycodone and acetaminophen TABLET ORAL 20151102 ANDA ANDA090535 Sun Pharmaceutical Industries, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 57664-156_26bd6fd5-7ec1-428d-aca5-a0de6604ad25 57664-156 HUMAN PRESCRIPTION DRUG oxycodone and acetaminophen oxycodone and acetaminophen TABLET ORAL 20151102 ANDA ANDA090535 Sun Pharmaceutical Industries, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 57664-160_26bd6fd5-7ec1-428d-aca5-a0de6604ad25 57664-160 HUMAN PRESCRIPTION DRUG oxycodone and acetaminophen oxycodone and acetaminophen TABLET ORAL 20151102 ANDA ANDA090535 Sun Pharmaceutical Industries, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 57664-162_7cd5d22a-81df-41dc-9fcf-96f5e4aae5a4 57664-162 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA074644 Sun Pharmaceutical Industries, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57664-162_ed4f5077-7c1b-4519-9f7f-5ed800551fe6 57664-162 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA074644 Sun Pharmaceutical Industries, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57664-166_7cd5d22a-81df-41dc-9fcf-96f5e4aae5a4 57664-166 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA074644 Sun Pharmaceutical Industries, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57664-166_ed4f5077-7c1b-4519-9f7f-5ed800551fe6 57664-166 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA074644 Sun Pharmaceutical Industries, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57664-167_7cd5d22a-81df-41dc-9fcf-96f5e4aae5a4 57664-167 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA074644 Sun Pharmaceutical Industries, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57664-167_ed4f5077-7c1b-4519-9f7f-5ed800551fe6 57664-167 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA074644 Sun Pharmaceutical Industries, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57664-170_5d1a641b-b76d-39bc-e053-2991aa0a3b1d 57664-170 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Sun Pharmaceutical Industries, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 57664-175_300906e6-6208-46e4-b8e0-c9613059051a 57664-175 HUMAN PRESCRIPTION DRUG Paromomycin Sulfate Paromomycin Sulfate CAPSULE ORAL 19970630 ANDA ANDA064171 Sun Pharmaceutical Industries, Inc. PAROMOMYCIN SULFATE 250 mg/1 Antiprotozoal [EPC] N 20181231 57664-176_5d1a641b-b76d-39bc-e053-2991aa0a3b1d 57664-176 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Sun Pharmaceutical Industries, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 57664-181_a0fe22f2-9063-49d4-831f-2271643b7d0a 57664-181 HUMAN PRESCRIPTION DRUG cetirizine hydrochloride cetirizine hydrochloride SYRUP ORAL 20091116 ANDA ANDA090191 Caraco Pharmaceutical Laboratories, Ltd. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 57664-187_1bafe705-a1bc-46a9-91c9-9e810ea61b6c 57664-187 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 Sun Pharmaceutical Industries, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57664-190_91e0aaad-8442-4e92-ad95-5cd125c85bc8 57664-190 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended-Release Morphine Sulfate Extended-Release TABLET ORAL 20160913 ANDA ANDA205634 Sun Pharmaceutical Industries, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57664-191_91e0aaad-8442-4e92-ad95-5cd125c85bc8 57664-191 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended-Release Morphine Sulfate Extended-Release TABLET ORAL 20160913 ANDA ANDA205634 Sun Pharmaceutical Industries, Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57664-192_91e0aaad-8442-4e92-ad95-5cd125c85bc8 57664-192 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended-Release Morphine Sulfate Extended-Release TABLET ORAL 20160913 ANDA ANDA205634 Sun Pharmaceutical Industries, Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57664-195_96393b08-817c-460c-a6f0-174755e764c7 57664-195 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20140417 ANDA ANDA090651 Sun Pharmaceutical Industries, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57664-196_91e0aaad-8442-4e92-ad95-5cd125c85bc8 57664-196 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended-Release Morphine Sulfate Extended-Release TABLET ORAL 20160913 ANDA ANDA205634 Sun Pharmaceutical Industries, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57664-197_91e0aaad-8442-4e92-ad95-5cd125c85bc8 57664-197 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended-Release Morphine Sulfate Extended-Release TABLET ORAL 20160913 ANDA ANDA205634 Sun Pharmaceutical Industries, Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57664-203_5fc8dccb-c6eb-0b9a-e053-2a91aa0a7bad 57664-203 HUMAN PRESCRIPTION DRUG Hydrocodone bitartrate and ibuprofen Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20130528 ANDA ANDA091633 Sun Pharmaceutical Industries, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 57664-210_615671e8-85e9-4793-e053-2991aa0a79f9 57664-210 HUMAN PRESCRIPTION DRUG Pramipexole Pramipexole TABLET ORAL 20130523 20181228 ANDA ANDA091683 Caraco Pharmaceutical Laboratories, Ltd. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 57664-211_84998e70-7d63-4f9b-9f71-9514e659e946 57664-211 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20171108 ANDA ANDA075713 Sun Pharmaceutical Industries, Inc. CLOZAPINE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 57664-212_684857ab-1155-450b-aedb-6da9af04301f 57664-212 HUMAN PRESCRIPTION DRUG RISPERIDONE risperidone TABLET ORAL 20140310 ANDA ANDA078036 Caraco Pharmaceutical Laboratories, Ltd. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 57664-213_684857ab-1155-450b-aedb-6da9af04301f 57664-213 HUMAN PRESCRIPTION DRUG RISPERIDONE risperidone TABLET ORAL 20140310 ANDA ANDA078036 Caraco Pharmaceutical Laboratories, Ltd. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 57664-214_684857ab-1155-450b-aedb-6da9af04301f 57664-214 HUMAN PRESCRIPTION DRUG RISPERIDONE risperidone TABLET ORAL 20140310 ANDA ANDA078036 Caraco Pharmaceutical Laboratories, Ltd. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 57664-215_684857ab-1155-450b-aedb-6da9af04301f 57664-215 HUMAN PRESCRIPTION DRUG RISPERIDONE risperidone TABLET ORAL 20140310 ANDA ANDA078036 Caraco Pharmaceutical Laboratories, Ltd. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 57664-216_684857ab-1155-450b-aedb-6da9af04301f 57664-216 HUMAN PRESCRIPTION DRUG RISPERIDONE risperidone TABLET ORAL 20140310 ANDA ANDA078036 Caraco Pharmaceutical Laboratories, Ltd. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 57664-217_684857ab-1155-450b-aedb-6da9af04301f 57664-217 HUMAN PRESCRIPTION DRUG RISPERIDONE risperidone TABLET ORAL 20140310 ANDA ANDA078036 Caraco Pharmaceutical Laboratories, Ltd. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 57664-223_1bafe705-a1bc-46a9-91c9-9e810ea61b6c 57664-223 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 Sun Pharmaceutical Industries, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57664-224_1bafe705-a1bc-46a9-91c9-9e810ea61b6c 57664-224 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 Sun Pharmaceutical Industries, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57664-228_e4c27d47-e09a-4ff7-bde2-174728667916 57664-228 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20130816 ANDA ANDA090710 Sun Pharmaceutical Industries, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-229_e4c27d47-e09a-4ff7-bde2-174728667916 57664-229 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20130816 ANDA ANDA090710 Sun Pharmaceutical Industries, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-230_e4c27d47-e09a-4ff7-bde2-174728667916 57664-230 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20130816 ANDA ANDA090710 Sun Pharmaceutical Industries, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-231_6155acd9-8e62-a87d-e053-2991aa0a7b43 57664-231 HUMAN PRESCRIPTION DRUG Nitrofurantion Nitrofurantion CAPSULE ORAL 20160415 ANDA ANDA201722 Sun Pharmaceutical Industries, Inc. NITROFURANTOIN 25 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 57664-232_6155acd9-8e62-a87d-e053-2991aa0a7b43 57664-232 HUMAN PRESCRIPTION DRUG Nitrofurantion Nitrofurantion CAPSULE ORAL 20160415 ANDA ANDA201722 Sun Pharmaceutical Industries, Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 57664-233_6155acd9-8e62-a87d-e053-2991aa0a7b43 57664-233 HUMAN PRESCRIPTION DRUG Nitrofurantion Nitrofurantion CAPSULE ORAL 20160415 ANDA ANDA201722 Sun Pharmaceutical Industries, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 57664-241_84998e70-7d63-4f9b-9f71-9514e659e946 57664-241 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20050819 ANDA ANDA075713 Sun Pharmaceutical Industries, Inc. CLOZAPINE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 57664-242_231b19c0-5ee3-33c1-e054-00144ff88e88 57664-242 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077346 Sun Pharmaceutical Industries, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 57664-244_231b19c0-5ee3-33c1-e054-00144ff88e88 57664-244 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077346 Sun Pharmaceutical Industries, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 57664-245_231b19c0-5ee3-33c1-e054-00144ff88e88 57664-245 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077346 Sun Pharmaceutical Industries, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 57664-246_328285dd-127a-4515-8898-dfde4ac20251 57664-246 HUMAN OTC DRUG Cetirizine Hydrochloride HIVES Cetirizine Hydrochloride SOLUTION ORAL 20111201 ANDA ANDA091327 Caraco Pharmaceutical Laboratories, Ltd CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 57664-247_231b19c0-5ee3-33c1-e054-00144ff88e88 57664-247 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077346 Sun Pharmaceutical Industries, Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 57664-263_60c4d8e0-3578-4ad3-aaad-272d1c1b5afd 57664-263 HUMAN OTC DRUG CETIRIZINE HYDROLORIDE Allergy CETIRIZINE HYDROLORIDE SOLUTION ORAL 20111201 ANDA ANDA091327 Caraco Pharmaceutical Laboratories, Ltd CETIRIZINE HYDROCHLORIDE 1 mg/mL E 20171231 57664-273_695b921a-28dc-4945-9a91-b04727509529 57664-273 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20010831 ANDA ANDA075423 Caraco Pharmaceutical Laboratories, Ltd. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 57664-274_695b921a-28dc-4945-9a91-b04727509529 57664-274 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20010831 ANDA ANDA075423 Caraco Pharmaceutical Laboratories, Ltd. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 57664-275_695b921a-28dc-4945-9a91-b04727509529 57664-275 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20010831 ANDA ANDA075423 Caraco Pharmaceutical Laboratories, Ltd. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 57664-280_5fc8dccb-c6eb-0b9a-e053-2a91aa0a7bad 57664-280 HUMAN PRESCRIPTION DRUG Hydrocodone bitartrate and ibuprofen Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20130528 ANDA ANDA091633 Sun Pharmaceutical Industries, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 57664-281_5fc8dccb-c6eb-0b9a-e053-2a91aa0a7bad 57664-281 HUMAN PRESCRIPTION DRUG Hydrocodone bitartrate and ibuprofen Hydrocodone bitartrate and ibuprofen TABLET, FILM COATED ORAL 20130528 ANDA ANDA091633 Sun Pharmaceutical Industries, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 2.5; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 57664-327_aa3b8a6e-c60c-47e3-8ccf-54d73c7e42aa 57664-327 HUMAN PRESCRIPTION DRUG Ticlopidine Hydrochloride Ticlopidine Hydrochloride TABLET, FILM COATED ORAL 20020926 ANDA ANDA075526 Caraco Pharmaceutical Laboratories, Ltd. TICLOPIDINE HYDROCHLORIDE 250 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 57664-345_84998e70-7d63-4f9b-9f71-9514e659e946 57664-345 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20021115 ANDA ANDA075713 Sun Pharmaceutical Industries, Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 57664-347_84998e70-7d63-4f9b-9f71-9514e659e946 57664-347 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20021115 ANDA ANDA075713 Sun Pharmaceutical Industries, Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 57664-357_4dec9bd6-6451-422d-aee2-dfbc55e0ca6e 57664-357 HUMAN PRESCRIPTION DRUG FLUVOXAMINE MALEATE fluvoxamine maleate TABLET ORAL 20060223 ANDA ANDA075900 Caraco Pharmaceutical Laboratories, Ltd. FLUVOXAMINE MALEATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-361_4dec9bd6-6451-422d-aee2-dfbc55e0ca6e 57664-361 HUMAN PRESCRIPTION DRUG FLUVOXAMINE MALEATE fluvoxamine maleate TABLET ORAL 20060223 ANDA ANDA075900 Caraco Pharmaceutical Laboratories, Ltd. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-362_4dec9bd6-6451-422d-aee2-dfbc55e0ca6e 57664-362 HUMAN PRESCRIPTION DRUG FLUVOXAMINE MALEATE fluvoxamine maleate TABLET ORAL 20060223 ANDA ANDA075900 Caraco Pharmaceutical Laboratories, Ltd. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-370_1bafe705-a1bc-46a9-91c9-9e810ea61b6c 57664-370 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20121119 ANDA ANDA090659 Sun Pharmaceutical Industries, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57664-371_1bafe705-a1bc-46a9-91c9-9e810ea61b6c 57664-371 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20121119 ANDA ANDA090659 Sun Pharmaceutical Industries, Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57664-376_68698e79-4e01-4935-b298-c64876bf40ec 57664-376 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride TABLET ORAL 20130926 ANDA ANDA201231 Sun Pharmaceutical Industries, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-377_15a62f03-27e2-4997-a5cb-a58bb3b2d033 57664-377 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 Sun Pharmaceutical Industries, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 57664-378_68698e79-4e01-4935-b298-c64876bf40ec 57664-378 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride TABLET ORAL 20130926 ANDA ANDA201231 Sun Pharmaceutical Industries, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-379_68698e79-4e01-4935-b298-c64876bf40ec 57664-379 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride TABLET ORAL 20130926 ANDA ANDA201231 Sun Pharmaceutical Industries, Inc. DEXMETHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-391_42a465c9-3cca-49aa-95bf-2658b3437218 57664-391 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20020103 ANDA ANDA075844 Caraco Pharmaceutical Laboratories, Ltd. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 57664-392_44ba9e6a-1676-4432-82a5-7071d2f139f1 57664-392 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Sun Pharmaceutical Industries, Inc. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-393_44ba9e6a-1676-4432-82a5-7071d2f139f1 57664-393 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Sun Pharmaceutical Industries, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-394_44ba9e6a-1676-4432-82a5-7071d2f139f1 57664-394 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Sun Pharmaceutical Industries, Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-395_44ba9e6a-1676-4432-82a5-7071d2f139f1 57664-395 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Sun Pharmaceutical Industries, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-396_44ba9e6a-1676-4432-82a5-7071d2f139f1 57664-396 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 Sun Pharmaceutical Industries, Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-397_aca1d4cb-3e37-40aa-9ab2-31b8a952841f 57664-397 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20020129 ANDA ANDA075967 Sun Pharmaceutical Industries, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 57664-398_caa37c20-2890-4349-be9d-5702a4470ea1 57664-398 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20090731 ANDA ANDA077820 Sun Pharmaceutical Industries, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 57664-399_caa37c20-2890-4349-be9d-5702a4470ea1 57664-399 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20090731 ANDA ANDA077820 Sun Pharmaceutical Industries, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 57664-419_6f20cd49-8c5a-4349-9611-105bed7537a9 57664-419 HUMAN PRESCRIPTION DRUG Aspirin, Caffeine, and Dihydrocodeine Bitartrate Aspirin, Caffeine, and Dihydrocodeine Bitartrate CAPSULE ORAL 20121001 NDA AUTHORIZED GENERIC NDA011483 Caraco Pharmaceutical Laboratories, Ltd ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE 356.4; 30; 16 mg/1; mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 57664-421_38e34831-580e-4773-a1a8-7358fee2424e 57664-421 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET ORAL 20070629 ANDA ANDA078194 Sun Pharmaceutical Industries, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-422_38e34831-580e-4773-a1a8-7358fee2424e 57664-422 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET ORAL 20070629 ANDA ANDA078194 Sun Pharmaceutical Industries, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-424_38e34831-580e-4773-a1a8-7358fee2424e 57664-424 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET ORAL 20070629 ANDA ANDA078194 Sun Pharmaceutical Industries, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-425_38e34831-580e-4773-a1a8-7358fee2424e 57664-425 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET ORAL 20070629 ANDA ANDA078194 Sun Pharmaceutical Industries, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-435_aca1d4cb-3e37-40aa-9ab2-31b8a952841f 57664-435 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20020129 ANDA ANDA075967 Sun Pharmaceutical Industries, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 57664-437_5d0ab45b-6b7b-4e0d-bf5e-c70300d84d14 57664-437 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20150217 ANDA ANDA076363 Sun Pharmaceutical Industries, Inc. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20191231 57664-441_5d0ab45b-6b7b-4e0d-bf5e-c70300d84d14 57664-441 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20150217 ANDA ANDA076363 Sun Pharmaceutical Industries, Inc. DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20191231 57664-467_4e5fe10f-cca0-4975-88a5-8f7df43ad93d 57664-467 HUMAN PRESCRIPTION DRUG meperidine hydrochloride meperidine hydrochloride TABLET ORAL 20070104 ANDA ANDA040446 Caraco Pharmaceutical Laboratories, Ltd. MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57664-471_4e5fe10f-cca0-4975-88a5-8f7df43ad93d 57664-471 HUMAN PRESCRIPTION DRUG meperidine hydrochloride meperidine hydrochloride TABLET ORAL 20070104 ANDA ANDA040446 Caraco Pharmaceutical Laboratories, Ltd. MEPERIDINE HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57664-474_aca1d4cb-3e37-40aa-9ab2-31b8a952841f 57664-474 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20020129 ANDA ANDA075967 Sun Pharmaceutical Industries, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 57664-477_7cd5d22a-81df-41dc-9fcf-96f5e4aae5a4 57664-477 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA074644 Sun Pharmaceutical Industries, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57664-477_ed4f5077-7c1b-4519-9f7f-5ed800551fe6 57664-477 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA074644 Sun Pharmaceutical Industries, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57664-499_5fb42dd8-4285-50e5-e053-2a91aa0a92cf 57664-499 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20040422 ANDA ANDA076541 Sun Pharmaceutical Industries, Inc. MIRTAZAPINE 15 mg/1 N 20181231 57664-500_5fb42dd8-4285-50e5-e053-2a91aa0a92cf 57664-500 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20040422 ANDA ANDA076541 Sun Pharmaceutical Industries, Inc. MIRTAZAPINE 30 mg/1 N 20181231 57664-501_5fb42dd8-4285-50e5-e053-2a91aa0a92cf 57664-501 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20040422 ANDA ANDA076541 Sun Pharmaceutical Industries, Inc. MIRTAZAPINE 45 mg/1 N 20181231 57664-502_0bf5dc84-a6ce-4b79-bb6c-e5a38187e67f 57664-502 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20031211 ANDA ANDA076416 Sun Pharmaceutical Industries, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 57664-503_0bf5dc84-a6ce-4b79-bb6c-e5a38187e67f 57664-503 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20031211 ANDA ANDA076416 Sun Pharmaceutical Industries, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 57664-506_7cd5d22a-81df-41dc-9fcf-96f5e4aae5a4 57664-506 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA076670 Sun Pharmaceutical Industries, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57664-506_ed4f5077-7c1b-4519-9f7f-5ed800551fe6 57664-506 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA076670 Sun Pharmaceutical Industries, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57664-507_481269e7-a38e-4df2-ad3c-eb359baad154 57664-507 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20150529 ANDA ANDA077032 Sun Pharmaceutical Industries, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-508_481269e7-a38e-4df2-ad3c-eb359baad154 57664-508 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20150529 ANDA ANDA077032 Sun Pharmaceutical Industries, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-509_481269e7-a38e-4df2-ad3c-eb359baad154 57664-509 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20150529 ANDA ANDA077032 Sun Pharmaceutical Industries, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 57664-510_5fb42dd8-4285-50e5-e053-2a91aa0a92cf 57664-510 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20040422 ANDA ANDA076541 Sun Pharmaceutical Industries, Inc. MIRTAZAPINE 7.5 mg/1 N 20181231 57664-537_cf5137e4-cf4f-47ba-aee4-f4909c747647 57664-537 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED ORAL 20051216 ANDA ANDA077184 Sun Pharmaceutical Industries, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 57664-540_5386c311-f7be-4e91-a8ab-a569105b165f 57664-540 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA077499 Caraco Pharmaceutical Laboratories, Ltd. CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 57664-541_5386c311-f7be-4e91-a8ab-a569105b165f 57664-541 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA077499 Caraco Pharmaceutical Laboratories, Ltd. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 57664-596_f1113456-7fa7-4233-9b36-8b11dc911636 57664-596 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20150408 ANDA ANDA202126 Sun Pharmaceuticals Industries, Inc. DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 57664-600_2475fda7-fd3b-472b-9c78-54749ba8e141 57664-600 HUMAN PRESCRIPTION DRUG ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE ORAL 20090922 ANDA ANDA040009 Caraco Pharmaceutical Laboratories Ltd. ISOSORBIDE DINITRATE 40 mg/1 N 20181231 57664-633_678d3921-cf6e-49a3-911f-e156be7563c0 57664-633 HUMAN PRESCRIPTION DRUG MIDAZOLAM MIDAZOLAM HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20120808 ANDA ANDA090696 Caraco Pharmaceutical Laboratories, Ltd. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 57664-634_76fa9e54-1e0d-45b6-8549-2a13e9addd10 57664-634 HUMAN PRESCRIPTION DRUG MIDAZOLAM MIDAZOLAM HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20120808 ANDA ANDA090850 Caraco Pharmaceutical Laboratories, Ltd. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 57664-641_d60d78b9-3d6c-4783-91c8-c42ba8745494 57664-641 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Sun Pharmaceutical Industries, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-642_d60d78b9-3d6c-4783-91c8-c42ba8745494 57664-642 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Sun Pharmaceutical Industries, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-643_d60d78b9-3d6c-4783-91c8-c42ba8745494 57664-643 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Sun Pharmaceutical Industries, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-644_d60d78b9-3d6c-4783-91c8-c42ba8745494 57664-644 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Sun Pharmaceutical Industries, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-645_d60d78b9-3d6c-4783-91c8-c42ba8745494 57664-645 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Sun Pharmaceutical Industries, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-646_d60d78b9-3d6c-4783-91c8-c42ba8745494 57664-646 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Sun Pharmaceutical Industries, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-647_d60d78b9-3d6c-4783-91c8-c42ba8745494 57664-647 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Sun Pharmaceutical Industries, Inc. DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57664-648_a8ae21be-86f2-44db-b702-d280e76de4ca 57664-648 HUMAN PRESCRIPTION DRUG Chlorthalidone Chlorthalidone TABLET ORAL 20160212 ANDA ANDA089286 Sun Pharmaceutical Industries, Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20191231 57664-649_a8ae21be-86f2-44db-b702-d280e76de4ca 57664-649 HUMAN PRESCRIPTION DRUG Chlorthalidone Chlorthalidone TABLET ORAL 20160212 ANDA ANDA089286 Sun Pharmaceutical Industries, Inc. CHLORTHALIDONE 50 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20191231 57664-650_bea768de-b1a6-4fbe-8555-6d1ac6019f16 57664-650 HUMAN PRESCRIPTION DRUG Labetalol Labetalol TABLET, FILM COATED ORAL 19990729 ANDA ANDA075215 Sun Pharmaceutical Industries, Inc. LABETALOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 57664-651_bea768de-b1a6-4fbe-8555-6d1ac6019f16 57664-651 HUMAN PRESCRIPTION DRUG Labetalol Labetalol TABLET, FILM COATED ORAL 19990729 ANDA ANDA075215 Sun Pharmaceutical Industries, Inc. LABETALOL 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 57664-652_bea768de-b1a6-4fbe-8555-6d1ac6019f16 57664-652 HUMAN PRESCRIPTION DRUG Labetalol Labetalol TABLET, FILM COATED ORAL 19990729 ANDA ANDA075215 Sun Pharmaceutical Industries, Inc. LABETALOL 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 57664-653_3130c0b1-b7d5-4d0b-8511-971de4a04687 57664-653 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19860716 ANDA ANDA070772 Sun Pharmaceutical Industries, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 57664-654_3130c0b1-b7d5-4d0b-8511-971de4a04687 57664-654 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19860716 ANDA ANDA070773 Sun Pharmaceutical Industries, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 57664-655_cda10f42-3060-464e-9d28-89610947e699 57664-655 HUMAN PRESCRIPTION DRUG Pindolol Pindolol TABLET ORAL 19940127 ANDA ANDA074063 Sun Pharmaceutical Industries, Inc. PINDOLOL 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57664-656_cda10f42-3060-464e-9d28-89610947e699 57664-656 HUMAN PRESCRIPTION DRUG Pindolol Pindolol TABLET ORAL 19940127 ANDA ANDA074063 Sun Pharmaceutical Industries, Inc. PINDOLOL 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 57664-657_60155a3c-4f76-3c46-e053-2a91aa0a3dd5 57664-657 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19930312 20201231 ANDA ANDA073536 Sun Pharmaceutical Industries, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 57664-658_60155a3c-4f76-3c46-e053-2a91aa0a3dd5 57664-658 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19930312 20201231 ANDA ANDA073536 Sun Pharmaceutical Industries, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 57664-663_54ab8b25-c491-41f9-a5c0-943e70eb54f5 57664-663 HUMAN PRESCRIPTION DRUG Carvedilol Phosphate Carvedilol Phosphate CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA090132 Sun Pharmaceutical Industries, Inc. CARVEDILOL PHOSPHATE 10 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 57664-664_54ab8b25-c491-41f9-a5c0-943e70eb54f5 57664-664 HUMAN PRESCRIPTION DRUG Carvedilol Phosphate Carvedilol Phosphate CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA090132 Sun Pharmaceutical Industries, Inc. CARVEDILOL PHOSPHATE 20 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 57664-665_54ab8b25-c491-41f9-a5c0-943e70eb54f5 57664-665 HUMAN PRESCRIPTION DRUG Carvedilol Phosphate Carvedilol Phosphate CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA090132 Sun Pharmaceutical Industries, Inc. CARVEDILOL PHOSPHATE 40 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 57664-666_54ab8b25-c491-41f9-a5c0-943e70eb54f5 57664-666 HUMAN PRESCRIPTION DRUG Carvedilol Phosphate Carvedilol Phosphate CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA090132 Sun Pharmaceutical Industries, Inc. CARVEDILOL PHOSPHATE 80 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 57664-682_5bafaf3e-a5fa-01ff-e053-2991aa0a7286 57664-682 HUMAN PRESCRIPTION DRUG Linezolid linezolid INJECTION, SOLUTION INTRAVENOUS 20170201 ANDA ANDA207354 Sun Pharmaceutical Industries, Inc. LINEZOLID 200 mg/100mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 57664-683_5bafaf3e-a5fa-01ff-e053-2991aa0a7286 57664-683 HUMAN PRESCRIPTION DRUG Linezolid linezolid INJECTION, SOLUTION INTRAVENOUS 20170201 ANDA ANDA207354 Sun Pharmaceutical Industries, Inc. LINEZOLID 600 mg/300mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 57664-684_4553a3cb-255c-4ce9-8032-8fc296b63fc1 57664-684 HUMAN PRESCRIPTION DRUG Miglitol Miglitol TABLET, COATED ORAL 20160104 ANDA ANDA203965 Sun Pharmaceutical Industries Ltd. MIGLITOL 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 57664-685_4553a3cb-255c-4ce9-8032-8fc296b63fc1 57664-685 HUMAN PRESCRIPTION DRUG Miglitol Miglitol TABLET, COATED ORAL 20160104 ANDA ANDA203965 Sun Pharmaceutical Industries Ltd. MIGLITOL 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 57664-686_4553a3cb-255c-4ce9-8032-8fc296b63fc1 57664-686 HUMAN PRESCRIPTION DRUG Miglitol Miglitol TABLET, COATED ORAL 20160104 ANDA ANDA203965 Sun Pharmaceutical Industries Ltd. MIGLITOL 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 57664-687_85a9d644-bb0e-40b2-b8eb-35663bba25bd 57664-687 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19870714 ANDA ANDA089399 Sun Pharmaceutical Industries, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20191231 57664-688_85a9d644-bb0e-40b2-b8eb-35663bba25bd 57664-688 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19870714 ANDA ANDA089399 Sun Pharmaceutical Industries, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 57664-689_85a9d644-bb0e-40b2-b8eb-35663bba25bd 57664-689 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19870714 ANDA ANDA089399 Sun Pharmaceutical Industries, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 57664-690_85a9d644-bb0e-40b2-b8eb-35663bba25bd 57664-690 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19870714 ANDA ANDA089399 Sun Pharmaceutical Industries, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20191231 57664-691_85a9d644-bb0e-40b2-b8eb-35663bba25bd 57664-691 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19870714 ANDA ANDA089399 Sun Pharmaceutical Industries, Inc. AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20191231 57664-692_85a9d644-bb0e-40b2-b8eb-35663bba25bd 57664-692 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19870714 ANDA ANDA089399 Sun Pharmaceutical Industries, Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20191231 57664-745_c714b924-e75a-4e25-a910-2567977b61c6 57664-745 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20130711 ANDA ANDA077571 Sun Pharmaceutical Industries, Inc. REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20191231 57664-747_c714b924-e75a-4e25-a910-2567977b61c6 57664-747 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20130711 ANDA ANDA077571 Sun Pharmaceutical Industries, Inc. REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20191231 57664-755_c7159781-91e3-4789-92da-6e1eedea26ed 57664-755 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20161026 NDA NDA021286 Sun Pharmaceutical Industries, Inc. OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 57664-756_c7159781-91e3-4789-92da-6e1eedea26ed 57664-756 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20161026 NDA NDA021286 Sun Pharmaceutical Industries, Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 57664-757_c7159781-91e3-4789-92da-6e1eedea26ed 57664-757 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20161026 NDA NDA021286 Sun Pharmaceutical Industries, Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 57664-758_f81fcde7-476b-42f9-b1f8-2ede0e8fcb17 57664-758 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 NDA NDA021532 Sun Pharmaceutical Industries, Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57664-759_f81fcde7-476b-42f9-b1f8-2ede0e8fcb17 57664-759 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 NDA NDA021532 Sun Pharmaceutical Industries, Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57664-760_f81fcde7-476b-42f9-b1f8-2ede0e8fcb17 57664-760 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 NDA NDA021532 Sun Pharmaceutical Industries, Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57664-772_7a06f637-bc62-46f2-92d7-bfa50d2171d1 57664-772 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20161026 NDA NDA022100 Sun Pharmaceutical Industries, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 57664-773_7a06f637-bc62-46f2-92d7-bfa50d2171d1 57664-773 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20161026 NDA NDA022100 Sun Pharmaceutical Industries, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 57664-774_7a06f637-bc62-46f2-92d7-bfa50d2171d1 57664-774 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20161026 NDA NDA022100 Sun Pharmaceutical Industries, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 57664-775_7a06f637-bc62-46f2-92d7-bfa50d2171d1 57664-775 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20161026 NDA NDA022100 Sun Pharmaceutical Industries, Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 57664-783_cadb2925-8a95-4bf1-a736-25e62de85532 57664-783 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20170329 ANDA ANDA078654 Sun Pharmaceutical Industries, Inc. CLONAZEPAM .125 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 57664-784_cadb2925-8a95-4bf1-a736-25e62de85532 57664-784 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20170329 ANDA ANDA078654 Sun Pharmaceutical Industries, Inc. CLONAZEPAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 57664-785_cadb2925-8a95-4bf1-a736-25e62de85532 57664-785 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20170329 ANDA ANDA078654 Sun Pharmaceutical Industries, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 57664-786_cadb2925-8a95-4bf1-a736-25e62de85532 57664-786 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20170329 ANDA ANDA078654 Sun Pharmaceutical Industries, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 57664-787_cadb2925-8a95-4bf1-a736-25e62de85532 57664-787 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET, ORALLY DISINTEGRATING ORAL 20170329 ANDA ANDA078654 Sun Pharmaceutical Industries, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 57664-796_2fab1d53-93a7-44f0-bdba-a8537b63dbe4 57664-796 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 NDA NDA200175 Sun Pharmaceutical Industries, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 20; 5; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57664-797_2fab1d53-93a7-44f0-bdba-a8537b63dbe4 57664-797 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 NDA NDA200175 Sun Pharmaceutical Industries, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 5; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57664-798_2fab1d53-93a7-44f0-bdba-a8537b63dbe4 57664-798 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 NDA NDA200175 Sun Pharmaceutical Industries, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 5; 25 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57664-799_2fab1d53-93a7-44f0-bdba-a8537b63dbe4 57664-799 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 NDA NDA200175 Sun Pharmaceutical Industries, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 10; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57664-800_2fab1d53-93a7-44f0-bdba-a8537b63dbe4 57664-800 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 NDA NDA200175 Sun Pharmaceutical Industries, Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 10; 25 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 57664-808_c8492345-4226-47c6-88a0-f4b1f30c1bef 57664-808 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20170724 ANDA ANDA040684 Sun Pharmaceutical Industries, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 57664-851_9beb8c3e-33f3-4647-81e3-a8bb7a284395 57664-851 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20130513 ANDA ANDA090867 Sun Pharmaceutical Industries, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 57664-852_9beb8c3e-33f3-4647-81e3-a8bb7a284395 57664-852 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20130513 ANDA ANDA090867 Sun Pharmaceutical Industries, Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 57664-853_9beb8c3e-33f3-4647-81e3-a8bb7a284395 57664-853 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20130513 ANDA ANDA090867 Sun Pharmaceutical Industries, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 57664-854_c7150ebe-9a62-49cb-a9c1-7f548fd9ab46 57664-854 HUMAN PRESCRIPTION DRUG Minocycline Minocycline Hydrochloride TABLET, FILM COATED ORAL 20160129 ANDA ANDA090217 Sun Pharmaceuticals Industries, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 57664-855_c7150ebe-9a62-49cb-a9c1-7f548fd9ab46 57664-855 HUMAN PRESCRIPTION DRUG Minocycline Minocycline Hydrochloride TABLET, FILM COATED ORAL 20160129 ANDA ANDA090217 Sun Pharmaceuticals Industries, Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 57664-856_c7150ebe-9a62-49cb-a9c1-7f548fd9ab46 57664-856 HUMAN PRESCRIPTION DRUG Minocycline Minocycline Hydrochloride TABLET, FILM COATED ORAL 20160129 ANDA ANDA090217 Sun Pharmaceuticals Industries, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 57665-001_b0affb48-ca3f-46a7-8260-5a4819eb21d4 57665-001 HUMAN PRESCRIPTION DRUG Adagen pegademase bovine INJECTION, SOLUTION INTRAMUSCULAR 20101018 NDA NDA019818 Leadiant Biosciences, Inc. PEGADEMASE BOVINE 250 [iU]/mL Adenosine Deaminase [Chemical/Ingredient],Bovine Intestinal Adenosine Deaminase [EPC] N 20181231 57665-101_8aa0c695-943a-4a2d-9fcc-b8a6576bb88f 57665-101 HUMAN PRESCRIPTION DRUG ABELCET amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl- INJECTION INTRAVENOUS 20101018 NDA NDA050724 Leadiant Biosciences, Inc. AMPHOTERICIN B; DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-; DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- 5; 3.4; 1.5 mg/mL; mg/mL; mg/mL Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 57665-331_50ec5ad3-a2a9-4806-919d-809978aa6b28 57665-331 HUMAN PRESCRIPTION DRUG DepoCyt Cytarabine INJECTION, LIPID COMPLEX INTRATHECAL 20101022 NDA NDA021041 Sigma-Tau Pharmaceuticals, Inc. CYTARABINE 50 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 57670-000_60f024da-ab02-7f7a-e053-2991aa0a6c94 57670-000 HUMAN OTC DRUG restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex ZINC OXIDE LOTION TOPICAL 20121224 OTC MONOGRAPH NOT FINAL part352 RESTORSEA INC ZINC OXIDE 20 g/100g N 20181231 57677-005_08b34822-5067-4a70-90ee-337b990e5977 57677-005 HUMAN OTC DRUG Aveda Active Composition Menthol, Methyl Salicylate LIQUID TOPICAL 20110308 OTC MONOGRAPH FINAL part348 Aveda Corporation MENTHOL; METHYL SALICYLATE 1.25; 12.45 mL/50mL; mL/50mL N 20181231 57677-057_21172e1e-744d-4a12-82ee-079291e3b55d 57677-057 HUMAN OTC DRUG MINERAL TINTED MOISTURIZER SPF 15 TITANIUM DIOXIDE LOTION TOPICAL 20031101 OTC MONOGRAPH NOT FINAL part352 Aveda Corporation TITANIUM DIOXIDE 4.3 mL/100mL E 20171231 57677-059_b9855c21-da7e-4df5-a6a9-974efc254e03 57677-059 HUMAN OTC DRUG MINERAL TINTED MOISTURE BROAD SPECTRUM SPF 15 OIL FREE TITANIUM DIOXIDE LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 AVEDA COPORATION TITANIUM DIOXIDE .04601 g/mL N 20181231 57677-063_897329f7-257f-49d4-a623-f8c13a1de488 57677-063 HUMAN OTC DRUG DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 AVEDA COPORATION TITANIUM DIOXIDE; ZINC OXIDE 65.85; 42.85 mg/mL; mg/mL N 20181231 57685-7110_02a4201d-2574-4dcd-9208-d56f45b58016 57685-7110 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20130327 OTC MONOGRAPH NOT FINAL part333E APEX Sanitation, LLC ALCOHOL 540.26 g/L N 20181231 57687-238_6d6aff8f-1580-40c1-8dfe-cdfbe0e6660e 57687-238 HUMAN OTC DRUG Rescue Remedy Kids HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA FLOWER, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, and ORNITHOGALUM UMBELLATUM SOLUTION ORAL 20080301 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. HELIANTHEMUM NUMMULARIUM FLOWER; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; ORNITHOGALUM UMBELLATUM 5; 5; 5; 5; 5 [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL N 20181231 57687-239_495cb1cc-1128-43a3-b48f-10f3838a3c65 57687-239 HUMAN OTC DRUG Rescue Remedy HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA FLOWER, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, and ORNITHOGALUM UMBELLATUM SOLUTION ORAL 19930809 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. HELIANTHEMUM NUMMULARIUM FLOWER; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; ORNITHOGALUM UMBELLATUM 5; 5; 5; 5; 5 [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL N 20181231 57687-240_96a41425-88d7-4593-821e-9cbbdfb6b0fc 57687-240 HUMAN OTC DRUG Rescue Helianthemum nummularium flower, Clematis vitalba flower, Impatiens glandulifera flower, Prunus cerasifera flower, Ornithogalum umbellatum, and Malus domestica flower CREAM TOPICAL 20091001 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. HELIANTHEMUM NUMMULARIUM FLOWER; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; ORNITHOGALUM UMBELLATUM; MALUS DOMESTICA FLOWER 5; 5; 5; 5; 5; 5 [hp_X]/.5g; [hp_X]/.5g; [hp_X]/.5g; [hp_X]/.5g; [hp_X]/.5g; [hp_X]/.5g N 20181231 57687-241_49436592-b252-428a-923e-60f797f8b261 57687-241 HUMAN OTC DRUG Rescue Remedy HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA FLOWER, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, and ORNITHOGALUM UMBELLATUM SOLUTION ORAL 20050712 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. HELIANTHEMUM NUMMULARIUM WHOLE; CLEMATIS VITALBA WHOLE; IMPATIENS GLANDULIFERA WHOLE; PRUNUS CERASIFERA WHOLE; ORNITHOGALUM UMBELLATUM 5; 5; 5; 5; 5 [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL N 20181231 57687-242_a0cc5172-1642-4329-a740-13bf39b7c366 57687-242 HUMAN OTC DRUG Rescue Sleep HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA FLOWER, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, ORNITHOGALUM UMBELLATUM, and AESCULUS HIPPOCASTANUM FLOWER SOLUTION ORAL 20060421 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. HELIANTHEMUM NUMMULARIUM FLOWER; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; ORNITHOGALUM UMBELLATUM; AESCULUS HIPPOCASTANUM FLOWER 5; 5; 5; 5; 5; 5 [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL N 20181231 57687-245_99fee547-ac8f-47db-8aed-888dd572c8db 57687-245 HUMAN OTC DRUG Bach Pastilles Orange and Elderflower Helianthemum nummularium whole, Prunus cerasifera whole, Ornithogalum umbellatum, Clematis vitalba whole, and Impatiens glandulifera whole LOZENGE ORAL 20061120 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited HELIANTHEMUM NUMMULARIUM WHOLE; PRUNUS CERASIFERA WHOLE; ORNITHOGALUM UMBELLATUM; CLEMATIS VITALBA WHOLE; IMPATIENS GLANDULIFERA WHOLE 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57687-247_5546edd3-f61b-40e7-83e1-b07d3124aaf4 57687-247 HUMAN OTC DRUG Rescue Pastille Black Currant Helianthemum nummularium flower, Clematis Vitalba Top, Impatiens glandulifera flower, Prunus cerasifera flower, and Ornithogalum umbellatum LOZENGE ORAL 20150831 UNAPPROVED HOMEOPATHIC Nelson Bach USA Ltd HELIANTHEMUM NUMMULARIUM WHOLE; CLEMATIS VITALBA WHOLE; IMPATIENS GLANDULIFERA WHOLE; PRUNUS CERASIFERA WHOLE; ORNITHOGALUM UMBELLATUM 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57687-250_f08cee27-26b7-4397-a4a1-24562af86fde 57687-250 HUMAN OTC DRUG Bach Original Flower Remedies Agrimonia eupatoria SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited AGRIMONIA EUPATORIA 5 [hp_X]/.095mL N 20181231 57687-251_62f4c10c-135d-436c-b52c-693c9866d1fb 57687-251 HUMAN OTC DRUG Bach Original Flower Remedies Populus Tremula Whole SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited POPULUS TREMULA WHOLE 5 [hp_X]/.095mL N 20181231 57687-252_fe5e309d-61f3-41ed-8d08-d02606f814b9 57687-252 HUMAN OTC DRUG Bach Original Flower Remedies FAGUS SYLVATICA WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited FAGUS SYLVATICA WHOLE 5 [hp_X]/.095mL N 20181231 57687-253_8a07a30a-241c-4558-bb77-d27f45790949 57687-253 HUMAN OTC DRUG Bach Original Flower Remedies Centaurium Erythraea SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited CENTAURIUM ERYTHRAEA 5 [hp_X]/.095mL N 20181231 57687-254_df87ade8-6703-4c42-8b1e-ba82918facdb 57687-254 HUMAN OTC DRUG Bach Original Flower Remedies CERATOSTIGMA WILLMOTTIANUM WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited CERATOSTIGMA WILLMOTTIANUM WHOLE 5 [hp_X]/.095mL N 20181231 57687-255_5da149e5-f308-4a9a-951a-78def9254682 57687-255 HUMAN OTC DRUG Bach Original Flower Remedies PRUNUS CERASIFERA WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited PRUNUS CERASIFERA WHOLE 5 [hp_X]/.095mL N 20181231 57687-256_2550b946-7423-43b6-b76d-a752a4904f02 57687-256 HUMAN OTC DRUG Bach Original Flower Remedies Aesculus hippocastanum whole SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited AESCULUS HIPPOCASTANUM WHOLE 5 [hp_X]/.095mL N 20181231 57687-257_757f1d8d-344e-4c29-8a33-6e4934ecc2b8 57687-257 HUMAN OTC DRUG Bach Original Flower Remedies CICHORIUM INTYBUS WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited CICHORIUM INTYBUS WHOLE 5 [hp_X]/.095mL N 20181231 57687-258_4ce54166-f74c-4fe5-89ff-17e90e4829ce 57687-258 HUMAN OTC DRUG Bach Original Flower Remedies Clematis Vitalba Top SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited CLEMATIS VITALBA TOP 5 [hp_X]/.095mL N 20181231 57687-259_9c3af67b-380f-4a4c-8a61-d64bcba95bd9 57687-259 HUMAN OTC DRUG Bach Original Flower Remedies Malus Sylvestris Whole SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited MALUS SYLVESTRIS WHOLE 5 [hp_X]/.095mL N 20181231 57687-260_2267fb51-c513-40cb-a2de-324009f3844e 57687-260 HUMAN OTC DRUG Bach Original Flower Remedies Ulmus Procera Whole SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited ULMUS MINOR WHOLE 5 [hp_X]/.095mL N 20181231 57687-261_66a81a4f-e2b0-4606-bace-0eb01ea3b849 57687-261 HUMAN OTC DRUG Bach Original Flower Remedies GENTIANELLA AMARELLA WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited GENTIANELLA AMARELLA WHOLE 5 [hp_X]/.095mL N 20181231 57687-262_8434229d-48ca-4d11-b5ea-2514ed273193 57687-262 HUMAN OTC DRUG Bach Original Flower Remedies Ulex europaeus flower SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited ULEX EUROPAEUS FLOWER 5 [hp_X]/.095mL N 20181231 57687-263_69269418-8782-40bb-aff1-94fe4c2240b6 57687-263 HUMAN OTC DRUG Bach Original Flower Remedies CARLINA VULGARIS WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited CARLINA VULGARIS WHOLE 5 [hp_X]/.095mL N 20181231 57687-264_3028e848-bc9f-44db-860a-37945110d312 57687-264 HUMAN OTC DRUG Bach Original Flower Remedies Holly Ilex Aquifolium Fruiting Top SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited ILEX AQUIFOLIUM FRUITING TOP 5 [hp_X]/.095mL N 20181231 57687-265_716d93d8-684b-4e47-b0aa-72463e35a207 57687-265 HUMAN OTC DRUG Bach Original Flower Remedies LONICERA CAPRIFOLIUM WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited LONICERA CAPRIFOLIUM WHOLE 5 [hp_X]/.095mL N 20181231 57687-266_5d24cb04-3ff1-4a0b-8db9-4b8435a6b425 57687-266 HUMAN OTC DRUG Bach Original Flower Remedies Hornbeam Carpinus Betulus Flower SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited CARPINUS BETULUS FLOWER 5 [hp_X]/.095mL N 20181231 57687-267_9de0afe8-8546-43d2-a242-ee6b836c1368 57687-267 HUMAN OTC DRUG Bach Original Flower Remedies Impatiens glandulifera flower SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited IMPATIENS GLANDULIFERA FLOWER 5 [hp_X]/.095mL N 20181231 57687-268_54ca9bc7-3319-47fe-8e3e-53c97aedab84 57687-268 HUMAN OTC DRUG Bach Original Flower Remedies Larix decidua whole SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited LARIX DECIDUA WHOLE 5 [hp_X]/.095mL N 20181231 57687-269_b34acc52-3cc7-4234-bb53-228ce4c76625 57687-269 HUMAN OTC DRUG Bach Original Flower Remedies Mimulus guttatus whole SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited MIMULUS GUTTATUS WHOLE 5 [hp_X]/.095mL N 20181231 57687-270_72729daa-91e6-4092-b7e5-7f104ab943c5 57687-270 HUMAN OTC DRUG Bach Original Flower Remedies SINAPIS ARVENSIS WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited SINAPIS ARVENSIS WHOLE 5 [hp_X]/.095mL N 20181231 57687-271_6dbff1e2-a445-4642-842e-346205defde3 57687-271 HUMAN OTC DRUG Bach Original Flower Remedies QUERCUS ROBUR WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited QUERCUS ROBUR WHOLE 5 [hp_X]/.095mL N 20181231 57687-272_6546196b-43b1-49a9-a3a4-e71ded96361d 57687-272 HUMAN OTC DRUG Bach Original Flower Remedies OLEA EUROPAEA FLOWER SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited OLEA EUROPAEA FLOWER 5 [hp_X]/.095mL N 20181231 57687-273_9891f950-7cb4-4050-b661-ef5228ea2fdd 57687-273 HUMAN OTC DRUG Bach Original Flower Remedies PINUS SYLVESTRIS WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited PINUS SYLVESTRIS WHOLE 5 [hp_X]/.095mL N 20181231 57687-274_c51bd4b5-c745-46c8-a2b9-79010c67c420 57687-274 HUMAN OTC DRUG Bach Original Flower Remedies AESCULUS CARNEA WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited AESCULUS X CARNEA WHOLE 5 [hp_X]/.095mL N 20181231 57687-275_7e0da75d-4306-4ebe-a0af-9170ae75a426 57687-275 HUMAN OTC DRUG Bach Original Flower Remedies Helianthemum nummularium whole SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited HELIANTHEMUM NUMMULARIUM WHOLE 5 [hp_X]/.095mL N 20181231 57687-276_e8698dc1-a21c-4de3-b051-8a55be46d77c 57687-276 HUMAN OTC DRUG Bach Original Flower Remedies Water SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited WATER 5 [hp_X]/.095mL N 20181231 57687-277_1a7c7c8f-fa28-45ae-9f12-33fdd102f574 57687-277 HUMAN OTC DRUG Bach Original Flower Remedies Scleranthus annuus whole SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited SCLERANTHUS ANNUUS WHOLE 5 [hp_X]/.095mL N 20181231 57687-278_d4aa5031-2551-48dc-bee0-28d310ae3d5a 57687-278 HUMAN OTC DRUG Bach Original Flower Remedies Ornithogalum umbellatum SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited ORNITHOGALUM UMBELLATUM 5 [hp_X]/.095mL N 20181231 57687-279_a2300a4d-c51a-42a9-ae9e-8679f6fc2768 57687-279 HUMAN OTC DRUG Bach Original Flower Remedies CASTANEA SATIVA WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited CASTANEA SATIVA WHOLE 5 [hp_X]/.095mL N 20181231 57687-280_5de891c0-72ac-4df8-9e91-4cda52d7bbcc 57687-280 HUMAN OTC DRUG Bach Original Flower Remedies Verbena officinalis SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited VERBENA OFFICINALIS 5 [hp_X]/.095mL N 20181231 57687-281_55eb0d17-ffe9-405f-bdf4-570ad2278e29 57687-281 HUMAN OTC DRUG Bach Original Flower Remedies Vitis Vinifera whole SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited VITIS VINIFERA WHOLE 5 [hp_X]/.095mL N 20181231 57687-282_d35907b9-387e-4e8b-b896-0df8ff96696d 57687-282 HUMAN OTC DRUG Bach Original Flower Remedies Juglans regia whole SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited JUGLANS REGIA WHOLE 5 [hp_X]/.095mL N 20181231 57687-283_b6907c8f-64e6-4cd8-9dde-58370af83ff7 57687-283 HUMAN OTC DRUG Bach Original Flower Remedies Hottonia palustris flower SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited HOTTONIA PALUSTRIS FLOWER 5 [hp_X]/.095mL N 20181231 57687-284_8c1783d4-e65f-417e-b0a9-68ecc49611c1 57687-284 HUMAN OTC DRUG Bach Original Flower Remedies AESCULUS HIPPOCASTANUM FLOWER SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited AESCULUS HIPPOCASTANUM FLOWER 5 [hp_X]/.095mL N 20181231 57687-285_a242df88-9bf7-4e5c-97b8-1c8a50b56371 57687-285 HUMAN OTC DRUG Bach Original Flower Remedies Bromus Ramosus Whole SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited BROMUS RAMOSUS WHOLE 5 [hp_X]/.095mL N 20181231 57687-286_906c01fd-747b-47f8-96e9-9ab29b701377 57687-286 HUMAN OTC DRUG Bach Original Flower Remedies Rosa Canina Fruit SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited ROSA CANINA FRUIT 5 [hp_X]/.095mL N 20181231 57687-287_048ad6d7-2e0b-4abe-a116-e25e22e5a3dc 57687-287 HUMAN OTC DRUG Bach Original Flower Remedies SALIX ALBA WHOLE SOLUTION ORAL 20020101 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited SALIX ALBA WHOLE 5 [hp_X]/.095mL N 20181231 57687-291_282d1639-1959-4536-b92a-acbfcde802de 57687-291 HUMAN OTC DRUG Rescue Sleep Helianthemum nummularium flower, Clematis vitalba flower, Impatiens glandulifera flower, Prunus cerasifera flower, Ornithogalum umbellatum, and Aesculus hippocastanum flower CAPSULE, LIQUID FILLED ORAL 20100601 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. HELIANTHEMUM NUMMULARIUM FLOWER; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; ORNITHOGALUM UMBELLATUM; AESCULUS HIPPOCASTANUM FLOWER 5; 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57687-300_2af77106-3ddf-48b1-81f9-ea51bd0bcc4e 57687-300 HUMAN OTC DRUG Rescue Pastilles Cranberry HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA FLOWER, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, and ORNITHOGALUM UMBELLATUM LOZENGE ORAL 20120801 UNAPPROVED HOMEOPATHIC Nelson Bach USA Ltd HELIANTHEMUM NUMMULARIUM FLOWER; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; ORNITHOGALUM UMBELLATUM 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57687-301_2ad41aca-624a-4c25-8670-10bfd9cb6df1 57687-301 HUMAN OTC DRUG Rescue Pearls HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA FLOWER, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, AND ORNITHOGALUM UMBELLATUM CAPSULE, LIQUID FILLED ORAL 20120901 UNAPPROVED HOMEOPATHIC Nelson Bach USA Ltd HELIANTHEMUM NUMMULARIUM FLOWER; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; ORNITHOGALUM UMBELLATUM 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57687-303_4654f972-3cc0-40c9-b969-fbe872d94ce0 57687-303 HUMAN OTC DRUG Rescue Pastille Lemon HELIANTHEMUM NUMMULARIUM FLOWER, CLEMATIS VITALBA TOP, IMPATIENS GLANDULIFERA FLOWER, PRUNUS CERASIFERA FLOWER, and ORNITHOGALUM UMBELLATUM LOZENGE ORAL 20140130 UNAPPROVED HOMEOPATHIC Nelson Bach USA Ltd HELIANTHEMUM NUMMULARIUM FLOWER; CLEMATIS VITALBA TOP; IMPATIENS GLANDULIFERA FLOWER; PRUNUS CERASIFERA FLOWER; ORNITHOGALUM UMBELLATUM 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 57687-305_6b6c420e-997c-4361-9b57-5bbd6c395578 57687-305 HUMAN OTC DRUG Rescue Energy Clematis Vitalba Whole, Helianthemum Nummularium Whole, Impatiens Glandulifera Whole, Olea Europaea Flower, Ornithogalum Umbellatum, and Prunus Cerasifera Whole SOLUTION ORAL 20070208 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited CLEMATIS VITALBA WHOLE; HELIANTHEMUM NUMMULARIUM WHOLE; IMPATIENS GLANDULIFERA WHOLE; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA WHOLE 5; 5; 5; 5; 5; 5 [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL N 20181231 57687-510_cd970195-e567-4f6a-b2f6-9925f5b0a2d4 57687-510 HUMAN OTC DRUG Pure and Clear Exfoliating Wash Arnica montana, Calendula officinalis Flowering Top, and Hypericum perforatum SOLUTION TOPICAL 20100901 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM 6.25; 6.25; 6.25 [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL N 20181231 57687-901_265c1f0b-ce44-4ad1-80b1-54c9886d72ba 57687-901 HUMAN OTC DRUG Calendula Calendula Officinalis Flowering Top CREAM TOPICAL 19920331 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/.5g N 20181231 57687-902_a5f36379-d20c-4ed2-9a93-145ad7222e72 57687-902 HUMAN OTC DRUG Sting ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, Pyrethrum pale tincture, and RUMEX CRISPUS ROOT GEL TOPICAL 19960914 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PYRETHRUM EXTRACT; RUMEX CRISPUS ROOT 1; 1; 1; 1; 1; 1; 1 [hp_X]/.25g; [hp_X]/.25g; [hp_X]/.25g; [hp_X]/.25g; [hp_X]/.25g; [hp_X]/.25g; [hp_X]/.25g N 20181231 57687-906_e99fbf59-0fd6-42e8-a40e-8951ce1f13e1 57687-906 HUMAN OTC DRUG Cuts and Scrapes CALENDULA OFFICINALIS FLOWERING TOP and HYPERICUM PERFORATUM CREAM TOPICAL 19960914 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM 1; 1 [hp_X]/.25g; [hp_X]/.25g N 20181231 57687-910_a32dab99-ad61-4944-bf1d-eba33b98052a 57687-910 HUMAN OTC DRUG Pure and Clear Acne Treatment ARNICA MONTANA, CALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM, and SULFUR GEL TOPICAL 19980211 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; SULFUR 1; 1; 1; 6 [hp_X]/.25g; [hp_X]/.25g; [hp_X]/.25g; [hp_X]/.25g N 20181231 57687-920_5aa6b995-971d-433a-8aec-1a396dde524d 57687-920 HUMAN OTC DRUG H plus Care Hemorrhoid Horse Chestnut, Calendula Officinalis Flowering Top, Collinsonia Canadensis Root, Hamamelis Virginiana Root Bark/Stem Bark, and Paeonia Officinalis Root CREAM TOPICAL 20130401 UNAPPROVED HOMEOPATHIC Nelson Bach USA, Ltd. HORSE CHESTNUT; CALENDULA OFFICINALIS FLOWERING TOP; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PAEONIA OFFICINALIS ROOT 1; 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57687-922_c1f6c08d-7fe7-42d7-bef3-48bb34542828 57687-922 HUMAN OTC DRUG Nelsons Arnica Arnica Montana CREAM TOPICAL 20170104 UNAPPROVED HOMEOPATHIC Nelson Bach USA Limited ARNICA MONTANA 1 [hp_X]/.9mL N 20181231 57691-002_931da763-2cf8-407d-a76a-e52d33417798 57691-002 HUMAN OTC DRUG VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15 Octisalate, Avobenzone, and Octocrylene STICK TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part352 The Body Shop, Wake Forest OCTISALATE; AVOBENZONE; OCTOCRYLENE .05; .02; .03 g/g; g/g; g/g E 20171231 57691-107_369e0775-d4c4-404b-bd5a-66c44073b901 57691-107 HUMAN OTC DRUG 02 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL N 20181231 57691-108_369e0775-d4c4-404b-bd5a-66c44073b901 57691-108 HUMAN OTC DRUG 03 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL N 20181231 57691-109_369e0775-d4c4-404b-bd5a-66c44073b901 57691-109 HUMAN OTC DRUG 04 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL N 20181231 57691-110_369e0775-d4c4-404b-bd5a-66c44073b901 57691-110 HUMAN OTC DRUG 05 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL N 20181231 57691-112_369e0775-d4c4-404b-bd5a-66c44073b901 57691-112 HUMAN OTC DRUG 06 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL N 20181231 57691-113_369e0775-d4c4-404b-bd5a-66c44073b901 57691-113 HUMAN OTC DRUG 07 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL N 20181231 57691-161_369e0775-d4c4-404b-bd5a-66c44073b901 57691-161 HUMAN OTC DRUG 01 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL N 20181231 57691-162_369e0775-d4c4-404b-bd5a-66c44073b901 57691-162 HUMAN OTC DRUG 08 Moisture Foundation SPF 15 Octinoxate and Zinc Oxide EMULSION TOPICAL 20090906 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; ZINC OXIDE 3.75; 3.9 mg/.5mL; mg/.5mL N 20181231 57691-226_ffbb107b-0801-4a96-9387-7b139db4a74d 57691-226 HUMAN OTC DRUG The Body Shop Pomegranate SPF 15 Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 The Body Shop Wake Forest OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 4; 3 g/100mL; g/100mL; g/100mL N 20181231 57691-298_dc681ad5-1055-4be7-a3ab-5e4471008a90 57691-298 HUMAN OTC DRUG For Men Maca Root Energetic Face Protector SPF 15 Octisalate, Avobenzone, Octinoxate, and Octocrylene LOTION TOPICAL 20160314 OTC MONOGRAPH NOT FINAL part352 Buth-Na-Bodhaige, Inc., OCTISALATE; AVOBENZONE; OCTINOXATE; OCTOCRYLENE .05; .03; .029; .022 g/mL; g/mL; g/mL; g/mL E 20171231 57691-564_d29e026c-3570-4787-84f8-5741c568291a 57691-564 HUMAN OTC DRUG Satsuma Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E The Body Shop Wake Forest ALCOHOL .734 g/mL E 20171231 57691-566_89ea9829-df30-455c-8450-a27204d9f71c 57691-566 HUMAN OTC DRUG Mango Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E The Body Shop Wake Forest ALCOHOL .734 g/mL E 20171231 57691-569_b375d6bf-9046-4bbf-a223-52dbc887f90b 57691-569 HUMAN OTC DRUG Pink Grapefruit Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E The Body Shop Wake Forest ALCOHOL .734 g/mL E 20171231 57691-825_19e19bb9-9e37-47b0-a274-5268faff6af4 57691-825 HUMAN OTC DRUG Mango Antibacterial Hand Sanitizer Alcohol GEL TOPICAL 20111215 OTC MONOGRAPH NOT FINAL part333E The Body Shop, Wake Forest ALCOHOL .734 g/mL E 20171231 57691-889_1440375b-7c88-42f6-876d-e23640526f62 57691-889 HUMAN OTC DRUG Aloe Soothing Moisture SPF 15 Octisalate, Avobenzone, Octinoxate, and Octocrylene LOTION TOPICAL 20160411 OTC MONOGRAPH NOT FINAL part352 Buth-Na-Bodhaige, Inc., OCTISALATE; AVOBENZONE; OCTINOXATE; OCTOCRYLENE .05; .03; .029; .022 g/mL; g/mL; g/mL; g/mL E 20171231 57691-904_a10d00ca-9b57-4179-856b-a2d3446d9c1f 57691-904 HUMAN OTC DRUG Seaweed Oil-Control SPF 15 Octisalate, Avobenzone, Octinoxate, and Octocrylene LOTION TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part352 Buth-Na-Bodhaige, Inc., OCTISALATE; AVOBENZONE; OCTINOXATE; OCTOCRYLENE .05; .03; .029; .022 g/mL; g/mL; g/mL; g/mL E 20171231 57691-977_3f4dbd83-8fb1-450d-9361-3ce5cbef8dda 57691-977 HUMAN OTC DRUG VITAMIN C GLOW-PROTECT SPF 30 Octisalate, Avobenzone, Octinoxate, and Octocrylene LOTION TOPICAL 20160514 OTC MONOGRAPH NOT FINAL part352 Buth-Na-Bodhaige, Inc., OCTISALATE; AVOBENZONE; OCTINOXATE; OCTOCRYLENE .05; .02; .075; .05 g/mL; g/mL; g/mL; g/mL E 20171231 57698-100_ac2abb65-6239-40a8-b57b-f2238651965e 57698-100 HUMAN OTC DRUG TopiCool Pain Relief with Cats Claw Menthol GEL TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 TENSproducts, Inc. MENTHOL; CAMPHOR (NATURAL) 4.5; .4 g/100g; g/100g E 20171231 57698-100_b2c04c34-d07e-417c-a6a3-6f17bb20b24d 57698-100 HUMAN OTC DRUG TopiCool Pain Relief with Cats Claw Menthol GEL TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 TENSproducts, Inc. MENTHOL; CAMPHOR (NATURAL) 4.5; .4 g/100g; g/100g E 20171231 57702-464_14f30d68-789e-40d2-aacd-cb9f8556cc2d 57702-464 HUMAN OTC DRUG Zylast Antiseptic Ethyl Alcohol LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E Bocchi Laboratories Inc. ALCOHOL .76 mL/mL E 20171231 57702-465_514301b8-470b-47ff-b6ab-8c20e85f36ac 57702-465 HUMAN OTC DRUG Zylast XP Antiseptic Benzethonium Chloride LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E Bocchi Laboratories Inc. BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 57702-466_0455f2b3-a83a-41cd-ba1e-941ae2d70b56 57702-466 HUMAN OTC DRUG Zylast Antiseptic Surgical Scrub Ethyl Alcohol LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E Bocchi Laboratories Inc. ALCOHOL .76 mL/mL E 20171231 57702-487_4d8bdc3d-7ff7-4c87-a8cd-ec1ef25408da 57702-487 HUMAN OTC DRUG Zylast XP Antiseptic Foaming Benzethonium Chloride SOAP TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E Bocchi Laboratories Inc. BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 57707-050_d47fa3f7-b7af-400a-9b61-39f44bd56516 57707-050 HUMAN OTC DRUG Male Genital Desensitizer Stud 100 Lidocane SPRAY, METERED TOPICAL 20130313 OTC MONOGRAPH FINAL part348 Pound International Corp LIDOCAINE 9.6 mg/100mL N 20181231 57707-058_e61966ae-bf25-48bd-9b8d-a488ec24f009 57707-058 HUMAN OTC DRUG Premjact Male Desensitizer Pound International Lidocaine SPRAY, METERED TOPICAL 20130509 OTC MONOGRAPH NOT FINAL part348 Pound International LIDOCAINE 9.6 g/100mL N 20181231 57708-888_b7674537-bbbf-48e5-bdfd-54dd4f520afd 57708-888 HUMAN OTC DRUG NIN JIOM PEI PA KOA ELM BARK SYRUP ORAL 20060901 OTC MONOGRAPH NOT FINAL part356 NIN JIOM MEDICINE MANUFACTORY (HK) LTD ELM 650 mg/5mL E 20171231 57716-001_ceb0cfe6-3386-44de-900e-9dc419ccfb3f 57716-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040401 NDA NDA206023 Sky Oxygen OXYGEN 990 mL/L N 20181231 57718-010_f4f77bb3-e9a2-4995-a2ab-27c8f85fab5c 57718-010 HUMAN OTC DRUG CORRECT ESSENTIAL ACTIVATOR Glycerin, Allantoin CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part347 MIZON CO., LTD. GLYCERIN; ALLANTOIN 20; .6 mg/100mL; mg/100mL E 20171231 57718-020_3b5dca2e-0d2a-4ad6-a856-ac2f35474114 57718-020 HUMAN OTC DRUG CORRECT COMBO Glycerin CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part347 MIZON CO., LTD. GLYCERIN 7 mg/35mL E 20171231 57718-030_8cc727f5-ec75-48ae-af9e-394216f98f23 57718-030 HUMAN OTC DRUG UV BOUNCE MIST OCTINOXATE, OCTISALATE SPRAY TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 MIZON CO., LTD. OCTINOXATE; OCTISALATE 3.5; 2 mg/50mL; mg/50mL E 20171231 57718-040_23847ef7-b815-4e87-bf24-d8d3b28582f7 57718-040 HUMAN OTC DRUG ECO 10 Mineral Sun Pro Puff type Zinc oxide POWDER TOPICAL 20140703 OTC MONOGRAPH FINAL part347 MIZON CO., LTD. ZINC OXIDE 15.004 g/100g E 20171231 57718-050_5fddac99-a171-4146-be51-fe4d64a13563 57718-050 HUMAN OTC DRUG ECO 10 Mineral Sun Pro Automatic Brush Type Zinc oxide POWDER TOPICAL 20140703 OTC MONOGRAPH FINAL part347 MIZON CO., LTD. ZINC OXIDE 15.004 g/100g E 20171231 57718-060_22532d46-252a-45b6-b5b9-b95d00908b0b 57718-060 HUMAN OTC DRUG MIZON ACENCE BLEMISH OUT PINK SPOT Salicylic Acid SOLUTION TOPICAL 20150701 OTC MONOGRAPH FINAL part333D MIZON CO., LTD. SALICYLIC ACID .15 mg/30mL N 20181231 57718-070_eed75d95-f060-4512-9db5-42c5a27736d2 57718-070 HUMAN OTC DRUG MIZON UV SUN PROTECTOR Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 MIZON CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 3.67; 2.37; 2.15; 1.8 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 57718-080_f0f2a820-fc49-419e-85e4-62336533f83f 57718-080 HUMAN OTC DRUG MIZON ENJOY VITAL UP TIME Anti wrinkle Mask GLYCERIN PATCH TOPICAL 20151201 UNAPPROVED DRUG OTHER MIZON CO., LTD. GLYCERIN 3 g/101 N 20181231 57718-090_5e7b5143-2618-4194-93df-2f49100fbe8f 57718-090 HUMAN OTC DRUG ACENCE TEA TREE TOCK BLEMISH SPOT Salicylic Acid SOLUTION TOPICAL 20151201 OTC MONOGRAPH FINAL part333D MIZON CO., LTD. SALICYLIC ACID 22.5 mg/15mL N 20181231 57718-100_3105c946-7909-4abf-a653-80c45a0f142f 57718-100 HUMAN OTC DRUG MIZON GOOD NIGHT WHITE SLEEPING MASK DIMETHICONE CREAM TOPICAL 20160302 OTC MONOGRAPH FINAL part347 MIZON CO., LTD. DIMETHICONE .8 g/80mL N 20181231 57718-110_0e463f3f-bf33-4433-8af0-ded400c3e5a0 57718-110 HUMAN OTC DRUG MIZON ENJOY VITAL UP TIME Whitening Mask NIACINAMIDE PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER MIZON CO., LTD. NIACINAMIDE .6 g/101 N 20181231 57718-120_87cce6cd-55eb-492d-a5ab-62a1100632f7 57718-120 HUMAN OTC DRUG MELA DEFENSE WHITE ESSENCE Dimethicone GEL TOPICAL 20160302 OTC MONOGRAPH FINAL part347 MIZON CO., LTD. DIMETHICONE 1.05 g/50mL N 20181231 57718-130_1526b75e-a0e3-48e8-b43d-339f4310d77f 57718-130 HUMAN OTC DRUG MIZON ALL IN ONE SNAIL REPAIR Dimethicone CREAM TOPICAL 20160501 UNAPPROVED DRUG OTHER MIZON CO., LTD. DIMETHICONE .3 g/75mL N 20181231 57721-902_9978c84f-2a21-45fa-a197-a7e7b1152e03 57721-902 HUMAN PRESCRIPTION DRUG CAPTOPRIL captopril TABLET ORAL 19970328 ANDA ANDA074532 Windlas Healthcare (P) Ltd. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57721-903_9978c84f-2a21-45fa-a197-a7e7b1152e03 57721-903 HUMAN PRESCRIPTION DRUG CAPTOPRIL captopril TABLET ORAL 19970328 ANDA ANDA074532 Windlas Healthcare (P) Ltd. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57721-904_9978c84f-2a21-45fa-a197-a7e7b1152e03 57721-904 HUMAN PRESCRIPTION DRUG CAPTOPRIL captopril TABLET ORAL 19970328 ANDA ANDA074532 Windlas Healthcare (P) Ltd. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57721-905_9978c84f-2a21-45fa-a197-a7e7b1152e03 57721-905 HUMAN PRESCRIPTION DRUG CAPTOPRIL captopril TABLET ORAL 19970328 ANDA ANDA074532 Windlas Healthcare (P) Ltd. CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 57728-0001_89343176-23ba-468d-9bf0-2a0dd9af19f4 57728-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19910131 UNAPPROVED MEDICAL GAS Atlantic Medical Inc. OXYGEN 99 L/100L E 20171231 57775-000_54a707c4-7612-42fd-9a41-49c2e7e9706a 57775-000 HUMAN OTC DRUG Run Kang BZK Antiseptic Towelettes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part333A Taizhou Runkang Medical Products Co.,Ltd. BENZALKONIUM CHLORIDE .13 g/100g E 20171231 57775-001_198b7161-0106-4997-82fd-c8872d47dd0b 57775-001 HUMAN OTC DRUG Run Kang Alcohol Pads - MEDIUM ISOPROPYL ALCOHOL LIQUID TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part333A Taizhou Runkang Medical Products Co.,Ltd. ISOPROPYL ALCOHOL 70 g/100g E 20171231 57781-1073_0825e656-983c-4a43-b24d-68000552a185 57781-1073 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030205 UNAPPROVED MEDICAL GAS Promptcare Companies Inc. OXYGEN 99 L/100L E 20171231 57782-397_7369765e-ff46-4506-8cb1-b5d7f34f9156 57782-397 HUMAN OTC DRUG Cromolyn Sodium Cromolyn Sodium SPRAY, METERED NASAL 20010703 ANDA ANDA075702 Bausch & Lomb Incorporated CROMOLYN SODIUM 5.2 mg/mL N 20181231 57804-1020_64e73ecd-d239-48d2-8430-efeae4495ead 57804-1020 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900305 UNAPPROVED MEDICAL GAS Medic Rescue Health Care Company OXYGEN 99 L/100L E 20171231 57815-010_03980abd-259f-40df-86f1-38f386edabdf 57815-010 HUMAN OTC DRUG First Aid Shot Therapy Allergy Relief Diphenhydramine Hydrochloride SOLUTION ORAL 20160701 OTC MONOGRAPH FINAL part341 First Aid Beverages, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/40mL E 20171231 57815-011_35f33e4a-b409-4edd-8197-5f22b9d40210 57815-011 HUMAN OTC DRUG First Aid Shot Therapy Pain relief Choline Salicylate and Caffeine LIQUID ORAL 20130905 OTC MONOGRAPH NOT FINAL part343 First Aid Beverages, Inc. CHOLINE SALICYLATE; CAFFEINE 500; 65 mg/40mL; mg/40mL E 20171231 57815-021_7667dca1-8624-46de-ae69-b830dbe4d6bb 57815-021 HUMAN OTC DRUG First Aid Shot Therapy Upset Stomach Relief Calcium Carbonate SOLUTION ORAL 20131101 OTC MONOGRAPH FINAL part331 First Aid Beverages, Inc. CALCIUM CARBONATE 1250 mg/34mL E 20171231 57815-031_c4e9b0eb-f6f9-42a7-86dc-c2e6593eac70 57815-031 HUMAN OTC DRUG First Aid Shot Therapy Cold Relief Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Menthol SOLUTION ORAL 20150501 OTC MONOGRAPH FINAL part341 First Aid Beverages, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; MENTHOL 20; 10; 8.5 mg/40mL; mg/40mL; mg/40mL E 20171231 57815-041_390e006f-adee-455c-88ef-4c5875b8c256 57815-041 HUMAN OTC DRUG First Aid Shot Therapy Hangover Relief Choline Salicylate and Caffeine SOLUTION ORAL 20150201 OTC MONOGRAPH NOT FINAL part343 First Aid Beverages, Inc. CHOLINE SALICYLATE; CAFFEINE 870; 65 mg/40mL; mg/40mL E 20171231 57815-051_0510a32c-08d9-4111-8219-80b80cac3cdd 57815-051 HUMAN OTC DRUG First Aid Shot Therapy Heartburn Relief Calcium Carbonate LIQUID ORAL 20150301 OTC MONOGRAPH FINAL part331 First Aid Beverages, Inc. CALCIUM CARBONATE 1250 mg/40mL E 20171231 57815-081_30e7cd1c-f8da-4812-bc86-9f73c70764bb 57815-081 HUMAN OTC DRUG First Aid Shot Therapy Pain Relief Choline Salicylate and Caffeine LIQUID ORAL 20150201 OTC MONOGRAPH NOT FINAL part343 First Aid Beverages, Inc. CHOLINE SALICYLATE; CAFFEINE 650; 65 mg/40mL; mg/40mL E 20171231 57815-091_f3c496b1-188e-4a54-8c75-62da66a7c533 57815-091 HUMAN OTC DRUG First Aid Shot Therapy Sleep Aid Diphenhydramine Hydrochloride SOLUTION ORAL 20160701 OTC MONOGRAPH FINAL part338 First Aid Beverages, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/40mL E 20171231 57817-100_6b29ab21-944d-4229-8146-c6d182984b37 57817-100 HUMAN OTC DRUG antibacterial wet wipes Benzalkonium Chloride SWAB TOPICAL 20130329 OTC MONOGRAPH NOT FINAL part333A Hangzhou Haorun Technology CO.,LTD. BENZALKONIUM CHLORIDE .13 g/100g E 20171231 57817-200_402aac36-553a-4b77-9019-e6c72786a5f6 57817-200 HUMAN OTC DRUG HAND SANITIZER ALCOHOL GEL TOPICAL 20130330 OTC MONOGRAPH NOT FINAL part333E Hangzhou Haorun Technology CO.,LTD. ALCOHOL 62 mL/100mL E 20171231 57817-300_3f1e61d0-49ea-4d8d-ae28-7de4c24ae086 57817-300 HUMAN OTC DRUG SPF 30 Sunscreen OCTINOXATE OXYBENZONE Octisalate SPRAY TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part352 Hangzhou Haorun Technology CO.,LTD. OCTINOXATE; OXYBENZONE; OCTISALATE 6; 4; 5 g/100g; g/100g; g/100g E 20171231 57826-420_5c644a2c-2dc3-c305-e053-2991aa0a97fe 57826-420 HUMAN PRESCRIPTION DRUG Haemonetics Anticoagulant Sodium Citrate TRISODIUM CITRATE DIHYDRATE SOLUTION EXTRACORPOREAL 20130110 NDA BN980123 Haemonetics Corporation TRISODIUM CITRATE DIHYDRATE 40 mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 57826-426_e034d96f-82bc-43b3-b81f-192b5cdd0439 57826-426 HUMAN PRESCRIPTION DRUG Haemonetics Anticoagulant Citrate Dextrose Solution ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, DEXTROSE MONOHYDRATE SOLUTION EXTRACORPOREAL 20130110 ANDA BA980728 Haemonetics Corporation ANHYDROUS CITRIC ACID; TRISODIUM CITRATE DIHYDRATE; DEXTROSE MONOHYDRATE 73; 220; 245 mg/mL; mg/mL; mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 57826-441_9bb6ed6a-d739-4bbf-a519-8f67db3fd12b 57826-441 HUMAN PRESCRIPTION DRUG HAEMONETICS 0.9 % Sodium Chloride SODIUM CHLORIDE SOLUTION EXTRACORPOREAL 20130107 ANDA ANDA076316 Haemonetics Corporation SODIUM CHLORIDE 900 mg/100mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 57826-455_03cccd13-7d2f-4b47-9409-a888bb29bb12 57826-455 HUMAN PRESCRIPTION DRUG Haemonetics Anticoagulant Citrate Phosphate Double Dextrose Solution (CP2D) CITRIC ACID MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, ANHYDROUS DEXTROSE SOLUTION EXTRACORPOREAL 20130110 NDA BN000127 Haemonetics Corporation CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; ANHYDROUS DEXTROSE 32.7; 263; 22.2; 464 mg/mL; mg/mL; mg/mL; mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 57826-460_5ae72cea-f76f-4988-aaf3-a17aea22b69f 57826-460 HUMAN PRESCRIPTION DRUG Haemonetics Additive Solution Formula 3 (AS-3) CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE, ANHYDROUS DEXTROSE, TRISODIUM CITRATE DIHYDRATE SOLUTION EXTRACORPOREAL 20130110 NDA BN000127 Haemonetics Corporation CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM CHLORIDE; ADENINE; ANHYDROUS DEXTROSE; TRISODIUM CITRATE DIHYDRATE 4.2; 27.6; 41; 3; 100; 58.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 57826-462_1320508d-7f41-44f8-966b-5709413b9448 57826-462 HUMAN PRESCRIPTION DRUG Haemonetics Additive Solution Formula 3 (AS-3) CITRIC ACID MONOHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM CHLORIDE, ADENINE, ANHYDROUS DEXTROSE, TRISODIUM CITRATE DIHYDRATE SOLUTION EXTRACORPOREAL 20130107 NDA BN000127 Haemonetics Corporation CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM CHLORIDE; ADENINE; ANHYDROUS DEXTROSE; TRISODIUM CITRATE DIHYDRATE 4.2; 27.6; 41; 3; 100; 58.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 57842-7732_ef57b280-cd8b-482d-a03f-8cc33af66e24 57842-7732 HUMAN OTC DRUG DoctorRelief Menthol, Methyl Salicylate GEL TOPICAL 20091204 OTC MONOGRAPH FINAL part348 Biotanico Inc. MENTHOL; METHYL SALICYLATE; CAMPHOR (SYNTHETIC) 75; 38; 23 mg/g; mg/g; mg/g E 20171231 57842-7733_5aec74d3-a164-45ff-803a-e2d7f208b100 57842-7733 HUMAN OTC DRUG DoctorRelief Menthol, Methyl Salicylate and Camphor (synthetic) GEL TOPICAL 20180103 OTC MONOGRAPH FINAL part346 Biotanico Inc. MENTHOL; METHYL SALICYLATE; CAMPHOR (SYNTHETIC) 60; 20; 10 mg/1; mg/1; mg/1 N 20191231 57844-009_c751482c-aa86-4dfe-bdaa-85707c7b1c17 57844-009 HUMAN PRESCRIPTION DRUG Adipex-P Phentermine Hydrochloride TABLET ORAL 19900930 ANDA ANDA085128 Teva Select Brands PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 57844-019_c751482c-aa86-4dfe-bdaa-85707c7b1c17 57844-019 HUMAN PRESCRIPTION DRUG Adipex-P Phentermine Hydrochloride CAPSULE ORAL 19900930 ANDA ANDA088023 Teva Select Brands PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 57844-105_f993dec4-7106-41c1-b451-381dc373371b 57844-105 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20141113 ANDA ANDA040422 Teva Select Brands DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57844-110_f993dec4-7106-41c1-b451-381dc373371b 57844-110 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20140203 ANDA ANDA040422 Teva Select Brands DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57844-112_f993dec4-7106-41c1-b451-381dc373371b 57844-112 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20140618 ANDA ANDA040422 Teva Select Brands DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57844-115_f993dec4-7106-41c1-b451-381dc373371b 57844-115 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20140630 ANDA ANDA040422 Teva Select Brands DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57844-117_f993dec4-7106-41c1-b451-381dc373371b 57844-117 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20150303 ANDA ANDA040422 Teva Select Brands DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57844-120_f993dec4-7106-41c1-b451-381dc373371b 57844-120 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20140211 ANDA ANDA040422 Teva Select Brands DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57844-130_f993dec4-7106-41c1-b451-381dc373371b 57844-130 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 20140206 ANDA ANDA040422 Teva Select Brands DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 57844-151_5b21ba1b-2536-499b-a618-ef4e401810e4 57844-151 HUMAN PRESCRIPTION DRUG ORAP Pimozide TABLET ORAL 20000607 NDA NDA017473 Teva Select Brands PIMOZIDE 1 mg/1 Typical Antipsychotic [EPC] N 20181231 57844-198_5b21ba1b-2536-499b-a618-ef4e401810e4 57844-198 HUMAN PRESCRIPTION DRUG ORAP Pimozide TABLET ORAL 20141031 NDA NDA017473 Teva Select Brands PIMOZIDE 2 mg/1 Typical Antipsychotic [EPC] N 20181231 57844-208_ea858bb6-93ca-4e4c-8622-03bb5608a04d 57844-208 HUMAN PRESCRIPTION DRUG GALZIN Zinc Acetate CAPSULE ORAL 19970303 NDA NDA020458 Teva Select Brands ZINC ACETATE 50 mg/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 57844-215_ea858bb6-93ca-4e4c-8622-03bb5608a04d 57844-215 HUMAN PRESCRIPTION DRUG GALZIN Zinc Acetate CAPSULE ORAL 19970303 NDA NDA020458 Teva Select Brands ZINC ACETATE 25 mg/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 57844-322_d48f7e58-0596-4e19-ad0a-17eb9df0e17f 57844-322 HUMAN PRESCRIPTION DRUG Lofibra Fenofibrate CAPSULE ORAL 20021011 20180531 ANDA ANDA075753 Teva Select Brands FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 57844-323_d48f7e58-0596-4e19-ad0a-17eb9df0e17f 57844-323 HUMAN PRESCRIPTION DRUG Lofibra Fenofibrate CAPSULE ORAL 20020903 20180731 ANDA ANDA075753 Teva Select Brands FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 57844-510_f34da003-6601-4cf7-8036-b65d3c6606ea 57844-510 HUMAN PRESCRIPTION DRUG Adasuve loxapine AEROSOL, POWDER RESPIRATORY (INHALATION) 20140122 NDA NDA022549 Teva Select Brands LOXAPINE 10 mg/1 N 20181231 57844-691_988c31bf-17fd-4c6c-85ec-219a9d5eed7e 57844-691 HUMAN PRESCRIPTION DRUG Lofibra Fenofibrate TABLET, FILM COATED ORAL 20051123 20180430 ANDA ANDA076433 Teva Select Brands FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 57844-692_988c31bf-17fd-4c6c-85ec-219a9d5eed7e 57844-692 HUMAN PRESCRIPTION DRUG Lofibra Fenofibrate TABLET, FILM COATED ORAL 20051123 20180430 ANDA ANDA076433 Teva Select Brands FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 57850-0001_51938eb2-9193-4eba-a44c-986cb7195b35 57850-0001 HUMAN OTC DRUG FibroCane CALM Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis LIQUID ORAL 20131031 UNAPPROVED HOMEOPATHIC Premier Bioceuticals LLC. ACONITUM NAPELLUS; AESCULUS HIPPOCASTANUM FLOWER; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; ATROPA BELLADONNA; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57850-2000_42c04f05-6d86-4472-a603-7966390a04ea 57850-2000 HUMAN OTC DRUG Fibrocane Relief Symphytum officinale, Capsicum annuum, Ledum palustre, Colchicum autumnale, Rhododendron chrysanthum, Ruta graveolens, GEL TOPICAL 20140617 UNAPPROVED HOMEOPATHIC Premier Bioceuticals LLC COMFREY ROOT; CAPSICUM; LEDUM PALUSTRE TWIG; COLCHICUM AUTUMNALE BULB; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 3; 6; 6; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 57881-331_621fd88b-b921-47a2-94bd-a778d6005353 57881-331 HUMAN PRESCRIPTION DRUG Abstral fentanyl citrate TABLET SUBLINGUAL 20130808 NDA NDA022510 Galena Biopharma, Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57881-332_621fd88b-b921-47a2-94bd-a778d6005353 57881-332 HUMAN PRESCRIPTION DRUG Abstral fentanyl citrate TABLET SUBLINGUAL 20130808 NDA NDA022510 Galena Biopharma, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57881-333_621fd88b-b921-47a2-94bd-a778d6005353 57881-333 HUMAN PRESCRIPTION DRUG Abstral fentanyl citrate TABLET SUBLINGUAL 20130808 NDA NDA022510 Galena Biopharma, Inc. FENTANYL CITRATE 300 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57881-334_621fd88b-b921-47a2-94bd-a778d6005353 57881-334 HUMAN PRESCRIPTION DRUG Abstral fentanyl citrate TABLET SUBLINGUAL 20130808 NDA NDA022510 Galena Biopharma, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57881-336_621fd88b-b921-47a2-94bd-a778d6005353 57881-336 HUMAN PRESCRIPTION DRUG Abstral fentanyl citrate TABLET SUBLINGUAL 20130808 NDA NDA022510 Galena Biopharma, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57881-338_621fd88b-b921-47a2-94bd-a778d6005353 57881-338 HUMAN PRESCRIPTION DRUG Abstral fentanyl citrate TABLET SUBLINGUAL 20130808 NDA NDA022510 Galena Biopharma, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 57881-444_0a47e753-562e-46c4-8f08-604cceb517ad 57881-444 HUMAN PRESCRIPTION DRUG Zuplenz ondansetron FILM, SOLUBLE ORAL 20141008 NDA NDA022524 Galena Biopharma, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 57881-448_0a47e753-562e-46c4-8f08-604cceb517ad 57881-448 HUMAN PRESCRIPTION DRUG Zuplenz ondansetron FILM, SOLUBLE ORAL 20141008 NDA NDA022524 Galena Biopharma, Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 57883-401_601670c0-2cc8-fd5f-e053-2991aa0a1e74 57883-401 HUMAN PRESCRIPTION DRUG Keralac UREA CREAM TOPICAL 20110701 UNAPPROVED DRUG OTHER Brava Pharmaceuticals, LLC UREA 470 mg/g N 20181231 57883-402_53bdd864-40ec-4d22-e054-00144ff88e88 57883-402 HUMAN PRESCRIPTION DRUG Plexion SULFACETAMIDE SODIUM, SULFUR LIQUID TOPICAL 20050901 UNAPPROVED DRUG OTHER Brava Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 57883-403_51d6f7f5-2e73-129a-e054-00144ff88e88 57883-403 HUMAN PRESCRIPTION DRUG Plexion SULFACETAMIDE SODIUM, SULFUR CREAM TOPICAL 20050901 UNAPPROVED DRUG OTHER Brava Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 57883-404_52032141-dbd1-5918-e054-00144ff8d46c 57883-404 HUMAN PRESCRIPTION DRUG Plexion SULFACETAMIDE SODIUM, SULFUR CLOTH TOPICAL 20050901 UNAPPROVED DRUG OTHER Brava Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 57883-405_520077fa-204c-3367-e054-00144ff88e88 57883-405 HUMAN PRESCRIPTION DRUG Plexion SULFACETAMIDE SODIUM, SULFUR LOTION TOPICAL 20050901 UNAPPROVED DRUG OTHER Brava Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 98; 48 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 57884-2001_5cf14886-8061-684c-e053-2991aa0a389f 57884-2001 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20171026 ANDA ANDA091008 Jiangsu Hengrui Medicine Co. Ltd. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 57884-2002_5cf14886-8061-684c-e053-2991aa0a389f 57884-2002 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20171026 ANDA ANDA091008 Jiangsu Hengrui Medicine Co. Ltd. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 57884-2003_5cf14886-8061-684c-e053-2991aa0a389f 57884-2003 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20171026 ANDA ANDA091008 Jiangsu Hengrui Medicine Co. Ltd. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 57884-2021_5b5bbc77-9bde-4c21-e053-2991aa0a8135 57884-2021 HUMAN PRESCRIPTION DRUG LETROZOLE LETROZOLE TABLET ORAL 20130516 ANDA ANDA202716 Jiangsu Hengrui Medicine Co., Ltd. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 57884-3021_526a2ad8-53f1-480f-e054-00144ff88e88 57884-3021 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170215 ANDA ANDA203170 Jiangsu Hengrui Medicine Co., Ltd. DOCETAXEL 40 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 57884-3061_5a426ee0-2f8a-7e1b-e053-2991aa0a0b54 57884-3061 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20170127 ANDA ANDA204960 Jiangsu Hengrui Medicine Co., Ltd. CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 57884-3062_5811a96e-8eff-1865-e053-2a91aa0ad5d7 57884-3062 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20170831 ANDA ANDA209334 Jiangsu Hengrui Medicine Co., Ltd. CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 57884-3063_5a426ee0-2f8a-7e1b-e053-2991aa0a0b54 57884-3063 HUMAN PRESCRIPTION DRUG cisatracurium besylate cisatracurium besylate INJECTION INTRAVENOUS 20170919 ANDA ANDA204960 Jiangsu Hengrui Medicine Co., Ltd. CISATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 57884-3091_5b3268b1-d8ff-aad8-e053-2a91aa0a203c 57884-3091 HUMAN PRESCRIPTION DRUG DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170919 ANDA ANDA209065 Jiangsu Hengrui Medicine Co., Ltd. DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 57893-300_60a17f5d-4c24-dafe-e053-2991aa0aca14 57893-300 HUMAN PRESCRIPTION DRUG SelRx SELENIUM SULFIDE SHAMPOO TOPICAL 20110831 UNAPPROVED DRUG OTHER Artesa Labs, LLC SELENIUM SULFIDE 23 mg/mL N 20181231 57893-301_6017376f-a27e-0b1d-e053-2991aa0abf73 57893-301 HUMAN PRESCRIPTION DRUG Utopic UREA CREAM TOPICAL 20110815 UNAPPROVED DRUG OTHER Artesa Labs, LLC UREA 410 mg/g N 20181231 57893-302_60c85e6b-e5b1-09c2-e053-2a91aa0a9460 57893-302 HUMAN PRESCRIPTION DRUG Vytone HYDROCORTISONE ACETATE, IODOQUINOL CREAM TOPICAL 20110729 UNAPPROVED DRUG OTHER Artesa Labs, LLC HYDROCORTISONE ACETATE; IODOQUINOL 19; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 57893-303_13567600-018b-400e-83f8-4bfdb72fd0c2 57893-303 HUMAN OTC DRUG Riax BENZOYL PEROXIDE AEROSOL, FOAM TOPICAL 20110815 OTC MONOGRAPH FINAL part333D Artesa Labs, LLC BENZOYL PEROXIDE 55 mg/g N 20181231 57893-304_bc5176dc-04d7-4131-8ee2-f4abaae59942 57893-304 HUMAN OTC DRUG Riax BENZOYL PEROXIDE AEROSOL, FOAM TOPICAL 20110815 OTC MONOGRAPH FINAL part333D Artesa Labs, LLC BENZOYL PEROXIDE 95 mg/g N 20181231 57893-310_63ae1d4a-c426-6657-e053-2991aa0af037 57893-310 HUMAN PRESCRIPTION DRUG Nolix FLURANDRENOLIDE CREAM TOPICAL 20180126 ANDA ANDA205342 Artesa Labs, LLC FLURANDRENOLIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 57893-311_50212234-8596-0ac7-e054-00144ff8d46c 57893-311 HUMAN PRESCRIPTION DRUG Nolix FLURANDRENOLIDE LOTION TOPICAL 20170522 ANDA ANDA205343 Artesa Labs, LLC FLURANDRENOLIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 57894-030_dd84d623-c0c3-4783-9f5e-3b71c818bfd3 57894-030 HUMAN PRESCRIPTION DRUG REMICADE INFLIXIMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19980824 BLA BLA103772 Janssen Biotech, Inc. INFLIXIMAB, LICENSE HOLDER UNSPECIFIED 100 mg/10mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] N 20181231 57894-054_9864a6b0-c4cd-4c9e-b39b-737172835dd1 57894-054 HUMAN PRESCRIPTION DRUG Stelara ustekinumab SOLUTION INTRAVENOUS 20160923 BLA BLA761044 Janssen Biotech, Inc. USTEKINUMAB 130 mg/26mL Interleukin-12 Antagonist [EPC],Interleukin-12 Antagonists [MoA],Interleukin-23 Antagonist [EPC],Interleukin-23 Antagonists [MoA] N 20181231 57894-060_9864a6b0-c4cd-4c9e-b39b-737172835dd1 57894-060 HUMAN PRESCRIPTION DRUG STELARA ustekinumab INJECTION, SOLUTION SUBCUTANEOUS 20090925 BLA BLA125261 Janssen Biotech, Inc. USTEKINUMAB 45 mg/.5mL Interleukin-12 Antagonist [EPC],Interleukin-12 Antagonists [MoA],Interleukin-23 Antagonist [EPC],Interleukin-23 Antagonists [MoA] N 20181231 57894-061_9864a6b0-c4cd-4c9e-b39b-737172835dd1 57894-061 HUMAN PRESCRIPTION DRUG STELARA ustekinumab INJECTION, SOLUTION SUBCUTANEOUS 20090925 BLA BLA125261 Janssen Biotech, Inc. USTEKINUMAB 90 mg/mL Interleukin-12 Antagonist [EPC],Interleukin-12 Antagonists [MoA],Interleukin-23 Antagonist [EPC],Interleukin-23 Antagonists [MoA] N 20181231 57894-070_f5edb5fb-dc99-4a1e-b31e-7af786197897 57894-070 HUMAN PRESCRIPTION DRUG Simponi golimumab INJECTION, SOLUTION SUBCUTANEOUS 20090425 BLA BLA125289 Janssen Biotech, Inc. GOLIMUMAB 50 mg/.5mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] N 20181231 57894-071_f5edb5fb-dc99-4a1e-b31e-7af786197897 57894-071 HUMAN PRESCRIPTION DRUG Simponi golimumab INJECTION, SOLUTION SUBCUTANEOUS 20130515 BLA BLA125289 Janssen Biotech, Inc. GOLIMUMAB 100 mg/mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] N 20181231 57894-150_935b6ac5-a6c5-4ed5-8607-5fce4866fef0 57894-150 HUMAN PRESCRIPTION DRUG Zytiga abiraterone acetate TABLET ORAL 20110428 NDA NDA202379 Janssen Biotech, Inc. ABIRATERONE ACETATE 250 mg/1 Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 57894-184_935b6ac5-a6c5-4ed5-8607-5fce4866fef0 57894-184 HUMAN PRESCRIPTION DRUG Zytiga Abiraterone acetate TABLET, FILM COATED ORAL 20170417 NDA NDA202379 Janssen Biotech, Inc. ABIRATERONE ACETATE 250 mg/1 Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 57894-195_935b6ac5-a6c5-4ed5-8607-5fce4866fef0 57894-195 HUMAN PRESCRIPTION DRUG Zytiga Abiraterone acetate TABLET, FILM COATED ORAL 20170417 NDA NDA202379 Janssen Biotech, Inc. ABIRATERONE ACETATE 500 mg/1 Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 57894-200_d05a3820-37f2-4909-b9a9-2f62296706d3 57894-200 HUMAN PRESCRIPTION DRUG REOPRO abciximab INJECTION, SOLUTION INTRAVENOUS 20170103 BLA BLA103575 Janssen Biotech, Inc. ABCIXIMAB 2 mg/mL N 20181231 57894-350_c768f495-1a81-4956-9494-80e768262117 57894-350 HUMAN PRESCRIPTION DRUG SIMPONI ARIA golimumab SOLUTION INTRAVENOUS 20130719 BLA BLA125433 Janssen Biotech, Inc. GOLIMUMAB 50 mg/4mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] N 20181231 57894-420_62edb225-0ee5-4872-bb8a-927341b7696b 57894-420 HUMAN PRESCRIPTION DRUG SYLVANT siltuximab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140423 BLA BLA125496 Janssen Biotech, Inc. SILTUXIMAB 100 mg/1 Interleukin-6 Antagonist [EPC],Interleukin-6 Antagonists [MoA] N 20181231 57894-421_62edb225-0ee5-4872-bb8a-927341b7696b 57894-421 HUMAN PRESCRIPTION DRUG SYLVANT siltuximab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140401 BLA BLA125496 Janssen Biotech, Inc. SILTUXIMAB 400 mg/1 Interleukin-6 Antagonist [EPC],Interleukin-6 Antagonists [MoA] N 20181231 57894-502_7e98faf7-ed1d-49c6-adee-50b09f9684f0 57894-502 HUMAN PRESCRIPTION DRUG DARZALEX Daratumumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20151116 BLA BLA761036 Janssen Biotech, Inc. DARATUMUMAB 100 mg/5mL CD38-directed Cytolytic Antibody [EPC],CD38-directed Antibody Interactions [MoA],Antibodies, Monoclonal [Chemical/Ingredient] N 20181231 57894-640_67544126-b074-4339-80fb-441559eca749 57894-640 HUMAN PRESCRIPTION DRUG Tremfya Guselkumab INJECTION SUBCUTANEOUS 20170713 BLA BLA761061 Janssen Biotech, Inc. GUSELKUMAB 100 mg/mL Interleukin-23 Antagonist [EPC],Interleukin-23 Antagonists [MoA] N 20191231 57896-101_60798049-87f5-4b50-b1a0-8252970ee8a4 57896-101 HUMAN OTC DRUG Regular Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH FINAL part343 Geri-Care Pharmaceutical Corp ACETAMINOPHEN 325 mg/1 N 20181231 57896-102_6158e973-1b4e-26bc-e053-2991aa0aaafd 57896-102 HUMAN OTC DRUG Regular Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH NOT FINAL part343 Geri-Care Pharmaceutical Corp ACETAMINOPHEN 325 mg/1 N 20181231 57896-109_84ae6e32-7c89-4d54-b722-501d8ddda61e 57896-109 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 20181230 OTC MONOGRAPH FINAL part343 Geri-Care Pharmaceuticals, Corp ASPIRIN 325 mg/1 N 20181231 57896-184_1db6ad73-0ea2-4058-ad30-a3bce050ae1d 57896-184 HUMAN OTC DRUG Gericare Artificial Tears Lubricant Eye Glycerin SOLUTION/ DROPS OPHTHALMIC 20130630 OTC MONOGRAPH FINAL part349 Gericare Pharmaceuticals GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 .002; .002; .01 mg/mg; mg/mg; mg/mg N 20181231 57896-186_5640f4ab-5b3d-4638-e054-00144ff88e88 57896-186 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20161001 OTC MONOGRAPH FINAL part349 Geri-Care Pharmaceuticals, Corp WATER 99.05 mL/100mL N 20181231 57896-188_427259da-bbf2-4074-e054-00144ff8d46c 57896-188 HUMAN OTC DRUG Gericare Artificial Tears Lubricant Glycerin SOLUTION/ DROPS OPHTHALMIC 20161201 OTC MONOGRAPH FINAL part349 Geri-Care Pharmaceuticals, Corp GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 .002; .002; .01 mg/mg; mg/mg; mg/mg E 20171231 57896-199_2a2cbf0a-0628-4eb9-e054-00144ff8d46c 57896-199 HUMAN OTC DRUG TOLNAFTATE ANTIFUNGAL TOLNAFTATE POWDER TOPICAL 20110801 OTC MONOGRAPH FINAL part333C Geri-Care Pharmaceuticals, Corp TOLNAFTATE 1 g/100g N 20181231 57896-200_5f0fbe6d-cc1f-583e-e053-2991aa0a14c1 57896-200 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH NOT FINAL part343 Geri-Care Pharmaceutical Corp ACETAMINOPHEN 500 mg/1 N 20181231 57896-201_5f0ee4a8-7778-7ce5-e053-2991aa0a0c05 57896-201 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH NOT FINAL part343 Geri-Care Pharmaceutical Corp ACETAMINOPHEN 500 mg/1 N 20181231 57896-221_5f117932-ea4f-ed79-e053-2a91aa0a3e83 57896-221 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH NOT FINAL part343 Geri-Care Pharmaceutical Corp ACETAMINOPHEN 500 mg/1 N 20181231 57896-224_a09e533c-c2fb-42f6-aea2-f4f06fe65c6c 57896-224 HUMAN OTC DRUG Extra Strength Night Time Pain Medicine Acetaminophen, Diphenhydramine HCl TABLET ORAL 19960101 OTC MONOGRAPH FINAL part341 Geri-Care Pharmaceutical Corp ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 57896-226_6157820d-463b-ea51-e053-2991aa0a847b 57896-226 HUMAN OTC DRUG EXTRA PAIN RELIEVER ACETAMINOPHEN, ASPIRIN AND CAFFEINE TABLET, FILM COATED ORAL 20150701 OTC MONOGRAPH NOT FINAL part343 Geri-Care Pharmaceutical Corp ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 57896-251_a4bddcbd-503d-49b0-972c-87366740263e 57896-251 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen CAPSULE, GELATIN COATED ORAL 20070601 OTC MONOGRAPH NOT FINAL part343 Geri-Care Pharmaceutical Corp ACETAMINOPHEN 500 mg/1 N 20181231 57896-303_0c279b70-c3a5-69d4-e054-00144ff88e88 57896-303 HUMAN OTC DRUG Stool Softener with Laxative Docusate Sodium and Sennosides TABLET, FILM COATED ORAL 20141201 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 57896-339_fc3b137e-909a-4170-9a3b-83feaa333cd9 57896-339 HUMAN OTC DRUG Ear Wax Removal Drops Carbamide Peroxide - 6.5% SOLUTION/ DROPS TOPICAL 20140527 OTC MONOGRAPH FINAL part344 GeriCare Pharmaceutical Corp CARBAMIDE PEROXIDE 65 mg/mL N 20191231 57896-381_cb23bb84-14ae-4cfb-b235-6b70e3a4e1e4 57896-381 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20060101 ANDA ANDA076497 Geri-Care Pharmaceutical Corp LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 57896-391_c50fbf45-9711-4e9a-8235-0c14cc7fc127 57896-391 HUMAN OTC DRUG GERI-PECTATE VANILLA FLAVOR bismuth subsalicylate LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part335 Geri-Care Pharmaceuticals, Corp BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 57896-392_604fe4c7-b151-1ae3-e053-2991aa0ac615 57896-392 HUMAN OTC DRUG PINK BISMUTH bismuth subsalicylate LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part335 Geri-Care Pharmaceuticals, Corp BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 57896-396_8bbb137f-415d-421f-9cb4-97e56f506572 57896-396 HUMAN OTC DRUG GERI-PECTATE PEPPERMINT FLAVOR bismuth subsalicylate LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part335 Geri-Care Pharmaceuticals, Corp BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 57896-401_12c68280-d3e2-4bd1-b28f-4d74f11a7a35 57896-401 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp DOCUSATE SODIUM 100 mg/1 E 20171231 57896-407_6169cc7f-c58f-44d2-e053-2991aa0a59c9 57896-407 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20120101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp DOCUSATE SODIUM 100 mg/1 N 20181231 57896-421_3ec42148-6787-22f2-e054-00144ff8d46c 57896-421 HUMAN OTC DRUG STOOL SOFTENER docusate sodium TABLET ORAL 20150901 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceuticals, Corp DOCUSATE SODIUM 100 mg/1 N 20181231 57896-424_5f38aca9-139b-3a33-e053-2991aa0ad90b 57896-424 HUMAN OTC DRUG Docusate Calcium Stool Softener CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp DOCUSATE CALCIUM 240 mg/1 N 20181231 57896-425_612d2bd5-63dd-fcbc-e053-2a91aa0a6112 57896-425 HUMAN OTC DRUG Docusate Sodium Stool Softener CAPSULE, LIQUID FILLED ORAL 20160501 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp DOCUSATE SODIUM 250 mg/1 N 20181231 57896-435_604f7a52-600f-3086-e053-2a91aa0a03ec 57896-435 HUMAN OTC DRUG SORBITOL sorbitol SOLUTION RECTAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceuticals, Corp SORBITOL 13.5 g/15mL N 20181231 57896-440_5f86b510-9370-7d36-e053-2991aa0a832a 57896-440 HUMAN OTC DRUG stimulant laxative enteric coated Bisacodyl TABLET ORAL 20170301 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp BISACODYL 5 mg/1 N 20181231 57896-441_5f86e792-3243-4ee6-e053-2991aa0a54a0 57896-441 HUMAN OTC DRUG stimulant laxative enteric coated Bisacodyl TABLET ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp BISACODYL 5 mg/1 N 20181231 57896-444_6145267e-9ad2-23ed-e053-2991aa0a9593 57896-444 HUMAN OTC DRUG BISACODYL BISACODYL SUPPOSITORY RECTAL 20050101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp BISACODYL 10 mg/1 N 20181231 57896-449_84f15a32-a52d-450f-a0b3-85cd03faf947 57896-449 HUMAN OTC DRUG Fiber Laxative Calcium Polycarbophil TABLET ORAL 20040101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp CALCIUM POLYCARBOPHIL 625 mg/1 E 20171231 57896-450_616c8050-24c7-9f37-e053-2991aa0a7ef5 57896-450 HUMAN OTC DRUG Geri-kot Standardized Senna Concentrate TABLET ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp SENNOSIDES 8.6 mg/1 N 20181231 57896-451_cfb203d4-fc8a-4b85-b8fe-283ae80b850e 57896-451 HUMAN OTC DRUG Geri-kot Standardized Senna Concentrate TABLET ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp SENNOSIDES 8.6 mg/1 N 20181231 57896-455_26f45960-e2f7-4585-811c-dedc6f18f8d4 57896-455 HUMAN OTC DRUG Senna Plus Sennosides and Docusate Sodium TABLET ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 E 20171231 57896-458_616a896a-d239-7f7c-e053-2a91aa0a0f5b 57896-458 HUMAN OTC DRUG Senna Plus Sennosides and Docusate Sodium TABLET ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 57896-459_616b4399-7627-5e59-e053-2a91aa0a0f75 57896-459 HUMAN OTC DRUG Fiber Laxative Calcium Polycarbophil TABLET ORAL 20040101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceutical Corp CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 57896-461_8043d1a2-6243-4e62-97e8-ed3c2e7597d1 57896-461 HUMAN OTC DRUG Geri Mucil Psyllium POWDER, FOR SOLUTION ORAL 20090622 OTC MONOGRAPH NOT FINAL part334 Gericare Pharmaceuticals PSYLLIUM HUSK 3.4 g/7g N 20181231 57896-489_60cb4e75-40b1-ad58-e053-2a91aa0a3e24 57896-489 HUMAN OTC DRUG POLYETHYLENE GLYCOL 3350 polyethylene glycol 3350 POWDER, FOR SOLUTION ORAL 20140501 ANDA ANDA090812 Geri-Care Pharmaceutical Corp POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 57896-491_485cae8e-c22d-4263-b9bf-358e791c0325 57896-491 HUMAN OTC DRUG Geri mucil Psyllium Husks POWDER, FOR SOLUTION ORAL 20110208 OTC MONOGRAPH NOT FINAL part334 Gericare Pharmaceuticals PSYLLIUM HUSK 3.4 g/5.8g N 20181231 57896-617_efe2c0eb-aacd-4bff-8f2f-c6a02d9f9b62 57896-617 HUMAN OTC DRUG GAVIS-CARE ANTACID aluminum hydroxide and magnesium carbonate SUSPENSION ORAL 20000101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceuticals, Corp ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 95; 358 mg/15mL; mg/15mL N 20181231 57896-619_603b203d-a32a-1459-e053-2a91aa0a3231 57896-619 HUMAN OTC DRUG GERI-LANTA MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceuticals, Corp ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 57896-624_604f635f-1c9f-58f9-e053-2991aa0acecb 57896-624 HUMAN OTC DRUG GERI-LANTA SUPREME CHERRY calcium carbonate, magnesium hydroxide SUSPENSION ORAL 20000101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceuticals, Corp CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 400; 135 mg/5mL; mg/5mL N 20181231 57896-629_603d60a8-ef9a-63b2-e053-2a91aa0a989c 57896-629 HUMAN OTC DRUG GERI-LANTA ANTACID ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceuticals, Corp ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 57896-638_85b6d12c-a007-406b-9672-f6097fd6971b 57896-638 HUMAN OTC DRUG GERI-MOX MAX CHERRY aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20000101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceuticals, Corp ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 57896-639_603bb0ba-9ea5-4d2a-e053-2991aa0ab229 57896-639 HUMAN OTC DRUG GERI-MOX ANTACID ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20000101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceuticals, Corp ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 57896-647_5fc6e421-09f0-0f3f-e053-2a91aa0aae9d 57896-647 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceuticals, Corp MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 57896-648_9ef9bb75-0886-4726-8dda-8742e9138c9c 57896-648 HUMAN OTC DRUG MILK OF MAGNESIA CHERRY magnesium hydroxide LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part334 Geri-Care Pharmaceuticals, Corp MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 57896-649_61450055-c6c9-b0d9-e053-2a91aa0a2a6a 57896-649 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Geri-Care Pharmaceuticals, Corp MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 57896-676_61421283-27be-265e-e053-2991aa0a5cce 57896-676 HUMAN OTC DRUG SODIUM BICARBONATE Sodium Bicarbonate TABLET ORAL 20160601 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceutical Corp SODIUM BICARBONATE 650 mg/1 N 20181231 57896-681_61590b5a-ad24-4f62-e053-2991aa0a913b 57896-681 HUMAN OTC DRUG Geri-Dryl allergy relief Diphenhydramine HCl TABLET, COATED ORAL 20110901 OTC MONOGRAPH FINAL part336 Geri-Care Pharmaceutical Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 57896-691_612d55f3-54b1-488c-e053-2991aa0ae025 57896-691 HUMAN OTC DRUG EXTRA STRENGTH GAS RELIEF Simethicone TABLET, CHEWABLE ORAL 20151101 OTC MONOGRAPH FINAL part332 Geri-Care Pharmaceuticals, Corp DIMETHICONE 125 mg/1 N 20181231 57896-756_ea76bf14-dac7-4e9f-819f-fa863dfc96cd 57896-756 HUMAN OTC DRUG Guaiasorb DM Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 19950905 OTC MONOGRAPH FINAL part341 Geri-Care Pharmaceuticals, Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 57896-759_51eca36d-4019-0ffb-e054-00144ff88e88 57896-759 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20130401 ANDA ANDA078878 Gericare Pharmaceuticals OMEPRAZOLE MAGNESIUM 20.6 mg/1 N 20181231 57896-760_a6290b17-c395-4907-8739-b576dcb5271e 57896-760 HUMAN OTC DRUG Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080830 NDA NDA022032 Gericare Pharmaceuticals OMEPRAZOLE 20 mg/1 N 20181231 57896-761_d4c48506-6a3d-4d6b-2c7c-4315b16f73a0 57896-761 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130425 ANDA ANDA202194 Gericare Pharmaceuticals LANSOPRAZOLE 15 mg/1 N 20181231 57896-762_616bb658-5d0d-de11-e053-2991aa0a46b8 57896-762 HUMAN OTC DRUG CALCIUM CARBONATE CHEWABLE ANTACID calcium carbonate TABLET, CHEWABLE ORAL 20040101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceutical Corp CALCIUM CARBONATE 500 mg/1 N 20181231 57896-763_7067f708-81c1-4122-bc85-0fe1071de265 57896-763 HUMAN OTC DRUG CALCIUM CARBONATE CHEWABLE ANTACID calcium carbonate TABLET, CHEWABLE ORAL 20040101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceutical Corp CALCIUM CARBONATE 500 mg/1 E 20171231 57896-764_cab60283-7579-4c35-a7b0-7cbb48de1e61 57896-764 HUMAN OTC DRUG CALCIUM CARBONATE EXTRA STRENGTH ANTACID calcium carbonate TABLET, CHEWABLE ORAL 20040101 OTC MONOGRAPH FINAL part331 Geri-Care Pharmaceutical Corp CALCIUM CARBONATE 750 mg/1 E 20171231 57896-765_612fb47a-362c-2512-e053-2a91aa0abfed 57896-765 HUMAN OTC DRUG ACID REDUCER 75 Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20141101 ANDA ANDA075167 GERI-CARE PHARMACEUTICAL CORP RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 57896-770_612fb47a-3632-2512-e053-2a91aa0abfed 57896-770 HUMAN OTC DRUG ACID REDUCER 150 Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20141101 ANDA ANDA200172 GERI-CARE PHARMACEUTICAL CORP RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 57896-778_76d5d73a-bd78-4038-aaf8-0990b2bf98ce 57896-778 HUMAN OTC DRUG Travel-Ease Meclizine HCl TABLET ORAL 20040101 OTC MONOGRAPH FINAL part336 Geri-Care Pharmaceutical Corp MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 57896-784_250bc669-b6dc-4b6e-b695-3353b6d84e4e 57896-784 HUMAN OTC DRUG Allergy Relief Chlorpheniramine Maleate TABLET ORAL 20040901 OTC MONOGRAPH FINAL part341 Geri-Care Pharmaceutical Corp CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 57896-785_970090a3-20c7-4884-86a3-32698763c799 57896-785 HUMAN OTC DRUG Nighttime Sleep-aid Diphenhydramine HCl TABLET ORAL 20040101 OTC MONOGRAPH FINAL part338 Geri-Care Pharmaceutical Corp DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 57896-788_0daa5b57-2988-4a79-9c1a-7aae82c2cb46 57896-788 HUMAN OTC DRUG Allergy relief Loratadine TABLET ORAL 20080101 ANDA ANDA076471 Geri-Care Pharmaceutical Corp LORATADINE 10 mg/1 N 20181231 57896-791_615931fe-8874-a1f2-e053-2991aa0a6772 57896-791 HUMAN OTC DRUG SIMETHICONE Simethicone TABLET, CHEWABLE ORAL 20040101 OTC MONOGRAPH FINAL part332 Geri-Care Pharmaceuticals, Corp DIMETHICONE 80 mg/1 N 20181231 57896-792_6130f5d8-9e8a-32f6-e053-2a91aa0aba87 57896-792 HUMAN OTC DRUG EXTRA STRENGTH GAS RELIEF Simethicone CAPSULE, LIQUID FILLED ORAL 20170101 OTC MONOGRAPH FINAL part332 Geri-Care Pharmaceuticals, Corp DIMETHICONE 125 mg/1 N 20181231 57896-793_a76276e4-68eb-4c4e-8373-032f22e266ae 57896-793 HUMAN OTC DRUG GERI-TUSSIN EXPECTORANT Guaifenesin LIQUID ORAL 20000101 OTC MONOGRAPH FINAL part341 Geri-Care Pharmaceuticals, Corp GUAIFENESIN 100 mg/5mL E 20171231 57896-794_ae2ef9b1-bf2a-4b2d-b8ca-99913c1da321 57896-794 HUMAN OTC DRUG MUCUS RELIEF Guaifenesin TABLET ORAL 20040101 OTC MONOGRAPH FINAL part341 Geri-Care Pharmaceuticals, Corp GUAIFENESIN 400 mg/1 N 20181231 57896-798_5e08709c-8469-7f13-e053-2991aa0a09a6 57896-798 HUMAN OTC DRUG INFANTS GAS RELIEF Simethicone SUSPENSION ORAL 20140501 OTC MONOGRAPH FINAL part332 Geri-Care Pharmaceuticals, Corp DIMETHICONE 20 mg/.3mL N 20181231 57896-901_a16db6ea-96a3-4759-8e7b-0f82ff60e970 57896-901 HUMAN OTC DRUG Aspirin NSAID Aspirin TABLET ORAL 19930804 OTC MONOGRAPH NOT FINAL part343 Geri-Care Pharmaceuticals, Corp ASPIRIN 325 mg/1 N 20181231 57896-904_290be987-ccf6-4f27-81d4-3c76a8805c5d 57896-904 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 Geri-Care Pharmaceuticals, Corp ASPIRIN 325 mg/1 N 20181231 57896-911_616d8c4a-241b-d56c-e053-2991aa0aadec 57896-911 HUMAN OTC DRUG Low Strength Chewable Aspirin Aspirin TABLET, CHEWABLE ORAL 19950101 OTC MONOGRAPH NOT FINAL part343 Geri-Care Pharmaceutical Corp ASPIRIN 81 mg/1 N 20181231 57896-921_61744eff-8912-ca09-e053-2a91aa0a0527 57896-921 HUMAN OTC DRUG Regular Strength Enteric coated aspirin Aspirin TABLET, COATED ORAL 20000701 OTC MONOGRAPH FINAL part343 Geri-Care Pharmaceutical Corp ASPIRIN 325 mg/1 N 20181231 57896-922_527b905c-2203-2a87-e054-00144ff88e88 57896-922 HUMAN OTC DRUG Regular Strength Enteric coated aspirin Aspirin TABLET, COATED ORAL 20170201 OTC MONOGRAPH FINAL part343 Geri-Care Pharmaceutical Corp ASPIRIN 325 mg/1 N 20181231 57896-941_61691f99-73d8-e897-e053-2991aa0a3411 57896-941 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 20040101 ANDA ANDA075010 Geri-Care Pharmaceutical Corp IBUPROFEN 200 mg/1 N 20181231 57896-951_6156240f-b246-cf2c-e053-2a91aa0a87a7 57896-951 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20120501 ANDA ANDA090545 Geri-Care Pharmaceutical Corp NAPROXEN SODIUM 220 mg/1 N 20181231 57896-981_6159a699-d79c-56e1-e053-2991aa0ac41b 57896-981 HUMAN OTC DRUG Adult Low Dose Enteric Coated Aspirin Aspirin TABLET, COATED ORAL 20000701 OTC MONOGRAPH FINAL part343 Geri-Care Pharmaceutical Corp ASPIRIN 81 mg/1 N 20181231 57896-985_549aab5d-8165-1691-e054-00144ff88e88 57896-985 HUMAN OTC DRUG Adult Low Dose Enteric Coated Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20161001 OTC MONOGRAPH FINAL part343 Geri-Care Pharmaceutical Corp ASPIRIN 81 mg/1 N 20181231 57900-002_9fc97756-8b39-4e37-85f1-bffdc6d3334c 57900-002 HUMAN OTC DRUG cold hot patch Menthol PATCH TOPICAL 20140318 OTC MONOGRAPH NOT FINAL part348 Zhejiang Bangli Medical Products CO.,LTD MENTHOL 5 g/100g E 20171231 57902-249_295824de-b262-411f-b934-e39deafb62a3 57902-249 HUMAN PRESCRIPTION DRUG ERWINAZE Asparaginase INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20111118 BLA BLA125359 Jazz Pharmaceuticals, Inc. ASPARAGINASE ERWINIA CHRYSANTHEMI 10000 [iU]/mL Asparaginase [Chemical/Ingredient],Asparagine-specific Enzyme [EPC] N 20181231 57902-817_b548386e-33b7-450e-b6fe-ff1a83ad927c 57902-817 HUMAN PRESCRIPTION DRUG ProstaScint Kit for the Preparation of Indium In 111 Capromab Pendetide capromab pendetide KIT 19961028 BLA BLA103608 Jazz Pharmaceuticals, Inc. N 20181231 57902-860_8c2bb4be-91a7-4f05-a59e-0d05f7d18332 57902-860 HUMAN PRESCRIPTION DRUG Quadramet Samarium SM 153 Lexidronam INJECTION, SOLUTION INTRAVENOUS 19970519 NDA NDA020570 Jazz Pharmaceuticals, Inc. SAMARIUM SM-153 LEXIDRONAM PENTASODIUM 50 mCi/mL E 20171231 57910-100_46faf860-1949-4729-a4d7-3248e9012013 57910-100 HUMAN PRESCRIPTION DRUG Ibuprofen Immediate release Ibuprofen TABLET ORAL 20090205 ANDA ANDA078329 Shasun Pharmaceuticals Limited IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 57910-200_46faf860-1949-4729-a4d7-3248e9012013 57910-200 HUMAN PRESCRIPTION DRUG Ibuprofen Immediate release Ibuprofen TABLET ORAL 20090205 ANDA ANDA078329 Shasun Pharmaceuticals Limited IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 57910-300_46faf860-1949-4729-a4d7-3248e9012013 57910-300 HUMAN PRESCRIPTION DRUG Ibuprofen Immediate release Ibuprofen TABLET ORAL 20090205 ANDA ANDA078329 Shasun Pharmaceuticals Limited IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 57910-400_87234f8f-29b7-493f-8cd3-2e69ef44825c 57910-400 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110404 ANDA ANDA091355 Shasun Pharmaceuticals Limited IBUPROFEN 200 mg/1 N 20181231 57910-401_ddeff1be-cd83-4536-b29b-3420e29d7812 57910-401 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110428 ANDA ANDA079129 Shasun Pharmaceuticals Limited IBUPROFEN 200 mg/1 N 20181231 57910-402_052870b8-388e-4d0b-b8d5-ddbd106bfe93 57910-402 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110404 ANDA ANDA091355 Shasun Pharmaceuticals Limited IBUPROFEN 200 mg/1 N 20181231 57910-403_a3090bcd-9963-4f6a-9c19-37175ddbd53f 57910-403 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20110328 ANDA ANDA079129 Shasun Pharmaceuticals Limited IBUPROFEN 200 mg/1 N 20181231 57910-404_8b783df6-fc22-4128-9cd9-79637a17f97b 57910-404 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20110628 ANDA ANDA200536 Shasun Pharmaceuticals Limited RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 57910-405_51d82f41-0f1e-4eef-8410-a0e77598f025 57910-405 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20120229 ANDA ANDA201745 Shasun Pharmaceuticals Limited RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 57913-2525_fe301d66-7a2a-40ff-9f68-be31eefa5c3c 57913-2525 HUMAN OTC DRUG Luminous Intensive Hand Treatment SPF 25 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 20; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 57913-2815_949958b9-b17b-48ee-abf3-74cfd85103c9 57913-2815 HUMAN OTC DRUG Luminous Intensive Decollote Treatment SPF 20 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 20; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 57913-2832_2e3ca0d0-6d4b-48f1-8bf6-fb492a49a84a 57913-2832 HUMAN OTC DRUG Phelityl Day SPF 15 Avobenzone and Octinoxate LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE 20; 50 mg/mL; mg/mL N 20181231 57913-2833_fd8d743d-1cf0-4ec1-bca9-d83a323a4ffd 57913-2833 HUMAN OTC DRUG Firmarine Moisturizer SPF 30 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 57913-2834_6734af15-1a64-4b4b-a8f3-d707d871511f 57913-2834 HUMAN OTC DRUG R.E.M. Day SPF 30 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 57913-2857_5efdf937-f565-433c-a797-ff98d89e8cb9 57913-2857 HUMAN OTC DRUG Oil-Control Day SPF 15 Avobenzone and Octinoxate LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE 30; 75 mg/mL; mg/mL N 20181231 57913-2869_0ecc295b-a0c9-4bef-946d-8e675d3c2e91 57913-2869 HUMAN OTC DRUG Hydraphel Day SPF15 Avobenzone and Octinoxate CREAM TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 57913-2900_a711fc5c-534b-400a-bc28-431b4bb59977 57913-2900 HUMAN OTC DRUG Absolute Finish Foundation SPF15 Octinoxate and Titanium Dioxide LOTION TOPICAL 20130410 OTC MONOGRAPH NOT FINAL part352 Erno Laszlo, Inc. OCTINOXATE; TITANIUM DIOXIDE 75; 20 mg/mL; mg/mL N 20181231 57915-001_41871c75-9153-48d5-e054-00144ff88e88 57915-001 HUMAN OTC DRUG GERMSTARORIGINAL Isopropyl Alcohol SOLUTION TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333A Soaptronic, LLC ISOPROPYL ALCOHOL 700 g/1000g N 20181231 57915-002_418704d1-241f-32bf-e054-00144ff88e88 57915-002 HUMAN OTC DRUG germstarNORO Ethyl Alcohol SOLUTION TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333E Soaptronic, LLC ALCOHOL 630 g/1000g N 20181231 57915-003_4186b1ad-a4b3-2572-e054-00144ff8d46c 57915-003 HUMAN OTC DRUG germstarNORO unscented Ethyl Alcohol SOLUTION TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333E Soaptronic, LLC ALCOHOL 630 g/1000g N 20181231 57915-004_41871c75-9152-48d5-e054-00144ff88e88 57915-004 HUMAN OTC DRUG germstar Original unscented Isopropyl Alcohol SOLUTION TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333A Soaptronic, LLC ISOPROPYL ALCOHOL 700 g/1000g N 20181231 57915-005_4186a6fa-cc15-23d7-e054-00144ff8d46c 57915-005 HUMAN OTC DRUG germstarCitrus Ethyl Alcohol SOLUTION TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333E Soaptronic, LLC ALCOHOL 630 g/1000g N 20181231 57915-007_48bfca52-8bfb-71ea-e054-00144ff8d46c 57915-007 HUMAN OTC DRUG germstarLuxe Ethyl Alcohol SOLUTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333E Soaptronic, LLC ALCOHOL 630 g/1000g N 20181231 57915-008_489652af-7334-628a-e054-00144ff8d46c 57915-008 HUMAN OTC DRUG Germstar Premium Hand Sanitizer Ethyl Alcohol SOLUTION TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part333E Soaptronic LLC ALCOHOL 630 g/1000g N 20181231 57924-001_46e60c21-550e-4eb7-9572-f96fe6219750 57924-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20110103 UNAPPROVED MEDICAL GAS Ross Medical Supply Co. Inc. OXYGEN 991 mL/L E 20171231 57934-0103_b56662fd-14f8-4e5b-8636-97b66d7a0d1c 57934-0103 HUMAN OTC DRUG Antiperspirant Cedarwood Aluminum Chlorohydrate STICK TOPICAL 20130601 OTC MONOGRAPH FINAL part350 Every man jack ALUMINUM CHLOROHYDRATE 23 g/100g E 20171231 57934-0104_b56662fd-14f8-4e5b-8636-97b66d7a0d1c 57934-0104 HUMAN OTC DRUG Antiperspirant Sandalwood Aluminum Chlorohydrate STICK TOPICAL 20130601 OTC MONOGRAPH FINAL part350 Every man jack ALUMINUM CHLOROHYDRATE 23 g/100g E 20171231 57955-0001_138e991e-1005-4ab0-8f26-c4de627ab455 57955-0001 HUMAN OTC DRUG Eating Disorders Antimonium crudum, Cinchona officinalis, Ferrum metallicum, Hyoscyamus niger, Ignatia amara, Natrum muriaticum, Nux vomica, Phosphoricum acidum, Pulsatilla, Staphysagria, Thuja occidentalis, Veratrum album LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc ANTIMONY TRISULFIDE; CINCHONA OFFICINALIS BARK; IRON; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0002_e21e4c7e-70b8-4660-8a29-aae15fefbb18 57955-0002 HUMAN OTC DRUG Birth Ease Aletris farinosa, Apis mellifica, Arnica montana, Belladonna, Caulophyllum thalictroides, Chamomilla, Cimicifuga racemosa, Ferrum metallicum, Kali carbonicum, Sabina, Secale cornutum, Viburnum opulus LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0003_b2acf975-5120-476b-8280-b5b5fdb8d7d3 57955-0003 HUMAN OTC DRUG Breast Cyst and Discomforts Aconitum napellus, Bellis perennis, Bromium, Bryonia, Chamomilla, Conium maculatum, Iodium, Phellandrium aquaticum, Phytolacca decandra, Scrophularia nodosa, Silicea LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BELLIS PERENNIS; BROMINE; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CONIUM MACULATUM FLOWERING TOP; IODINE; OENANTHE AQUATICA FRUIT; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0004_9d32d328-3a74-4f60-9885-07f960902a22 57955-0004 HUMAN OTC DRUG Menstrual Cramps and Irregularities Cactus grandiflorus, Caulophyllum thalictroides, Chamomilla, Cimicifuga racemosa, Colocynthis, Ipecacuanha, Magnesia phosphorica, sepia, viburnum opulus, Xanthoxylum fraxineum LIQUID ORAL 20150219 UNAPPROVED HOMEOPATHIC King Bio Inc. SELENICEREUS GRANDIFLORUS STEM; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; VIBURNUM OPULUS BARK; ZANTHOXYLUM AMERICANUM BARK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0005_db62ba25-39fe-4bec-9a2a-7b31638e8cb0 57955-0005 HUMAN OTC DRUG FertiCare Agnus castus, Apis mellifica, Aurum metallicum, Borax, Conium maculatum, Ferrum metallicum, Iodium, Lilium tigrinum, Lycopodium clavatum, Natrum muriatcum, Palladium metallicum, sepia LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. CHASTE TREE; APIS MELLIFERA; GOLD; SODIUM BORATE; CONIUM MACULATUM FLOWERING TOP; IRON; IODINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PALLADIUM; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0008_961b4a5f-13ef-4bd2-884f-1a07275be4ab 57955-0008 HUMAN OTC DRUG Morning Sickness Aletris farinosa, Amygdalus persica, Colchicum autumnale, cucurbita pepo, semen, Ferrum metallicum, Ipecacuanha, Lycopodium clavatum, Nux vomica, Phosphorus, Pulsatilla, Tabacum LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. ALETRIS FARINOSA ROOT; PRUNUS PERSICA FLOWER; COLCHICUM AUTUMNALE BULB; PUMPKIN SEED; IRON; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0010_208c0bcd-519c-485c-8cdf-91c66bd3f584 57955-0010 HUMAN OTC DRUG Male Strengthener Agnus castus, Arnica montana, Baryta carbonica, Caladium seguinum, Kali bromatum, Lycopodium clavatum, nuphar luteum, Nux vomica, Onosmodium virginianum, Phosphoricum acidum, Picnicum acidum, Selenium metallicum LIQUID ORAL 20140421 UNAPPROVED HOMEOPATHIC King Bio Inc. CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0011_3a958480-6e94-4997-bc51-2c12ee354984 57955-0011 HUMAN OTC DRUG Prostate Strengthener Baryta carbonica, Chimaphila umbellata, Clematis erecta, Conium maculatum, Digitalis purpurea, Phosphoricum acidum, Sabal serrulata, Selenium metallicum, Staphysagria, Thuja occidentalis, Zincum metallicum LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC King Bio Inc. BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0012_edc11c38-4f5f-4ad4-ad22-26dd26c9b00a 57955-0012 HUMAN OTC DRUG Bed Wetting prevention Belladonna, Bellis perennis, Benzoicum acidum, Causticum, Equisetum hyemale, Lycopodium clavatum, Phosphorus, Plantago Major, Rhus aromatica, Sepia LIQUID ORAL 20150831 UNAPPROVED HOMEOPATHIC King Bio Inc. ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0015_99484848-2b08-4bb0-9f53-ffca660ebf38 57955-0015 HUMAN OTC DRUG Attention and Learning Enhancement Baryta carbonica, Calcarea carbonica, Ignatia amara, Lycopodium clavatum, Magnesia carbonica, Natrum carbonicum, Natrum muriaticum, Thuja occidentalis LIQUID ORAL 20140528 UNAPPROVED HOMEOPATHIC King Bio Inc. BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0016_ce5b11c8-b06f-44d0-b78c-3e0725a0d6b9 57955-0016 HUMAN OTC DRUG ParaClenz Calcarea carbonica, chenopodium anthelminticum, cina, croton tiglium, filix mas, gambogia, granatum, lycopodium clavatum, mercurius corrosivus, natrum phosphoricum, santoninum, senna, spigelia anthelmia, stannum metallicum, tanacetum vulgare, teucrium marum, zingeber officinale LIQUID ORAL 20111118 UNAPPROVED HOMEOPATHIC King Bio Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; GAMBOGE; PUNICA GRANATUM ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SANTONIN; SENNA LEAF; SPIGELIA ANTHELMIA; TIN; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0017_3d5a2658-bdf1-4302-b35d-2b7f2d57c0ef 57955-0017 HUMAN OTC DRUG TonsilCure Ammonium muriaticum, Baryta carbonica, Belladonna, Calcarea phosphorica, Ferrum phosphoricum, Guaiacum, Kali muriaticum, Lycopodium clavatum, Mercurius solubilis, Phytolacca decandra, Silicea LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CHLORIDE; BARIUM CARBONATE; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; GUAIACUM OFFICINALE RESIN; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0018_9a0bf3e2-648f-4788-a264-a51a0185945b 57955-0018 HUMAN OTC DRUG Teething Agaricus muscarius, Belladonna, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Kreosotum, Zincum metallicum LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC King Bio Inc. AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; WOOD CREOSOTE; ZINC 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0019_49ea3fc9-c10d-45f9-8fdc-12ae079ad40e 57955-0019 HUMAN OTC DRUG Constipation Relief Alumina, Bellis perennis, Causticum, Collinsonia canadensis, Hydrastis canadensis, Lac defloratum, Natrum muriaticum, Nux vomica, Plumbum metallicum, sepia LIQUID ORAL 20160627 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0020_625faf31-7d90-4a3a-a673-43a87492b4a9 57955-0020 HUMAN OTC DRUG Diarrhea Relief Aloe socotrina, Chamomilla, Cinchona officinalis, Colocynthis, Croton tigium, Cuprum arsenicosum, Gelsemium sempervirens, Ipecacuanha, Nux vomica, Phosphoricum acidum, Podophyllum peltatum, Veratrum album LIQUID ORAL 20140508 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0021_feebffed-535b-43dc-b78d-cb4bd5294350 57955-0021 HUMAN OTC DRUG Gout Symptom Relief Ammonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, Urtica urens LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR BARK; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0022_fe0d575d-179f-453f-a770-87086cfe3381 57955-0022 HUMAN OTC DRUG Heartburn Relief Abies nigra, Arsenicum album, Condurango, Conium maculatum, Iris versicolor, Magnesia carbonica, Robinia pseudoacacia, Sulphuricum acidum LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. PICEA MARIANA RESIN; ARSENIC TRIOXIDE; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; IRIS VERSICOLOR ROOT; MAGNESIUM CARBONATE; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0023_d48b2082-0844-46f6-813d-ae2859869113 57955-0023 HUMAN OTC DRUG Hemorrhoid Relief Aesculus hippocastanum, Aloe socotrina, Collinsonia canadensis, Hamamelis virginiana, Muriaticum acidum, Nux vomica, Paeonia officinalis, Ratanhia, Sepia, Sulphur LIQUID ORAL 20140604 UNAPPROVED HOMEOPATHIC King Bio Inc. HORSE CHESTNUT; ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT; SEPIA OFFICINALIS JUICE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0024_2c6fdfbc-2e06-4e9c-958d-6a4807fdd44c 57955-0024 HUMAN OTC DRUG Indigestion Relief Antimonium crudum, Argentum nitricum, Carbo Vegetabilis, Chelidonium majus, Cinchona officinalis, Graphites, Hydrastis canadensis, Ipecacuanha, Kali carbonicum, Lycopodium clavatum, Nux vomica, Pulsatilla LIQUID ORAL 20121023 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; SILVER NITRATE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0028_0fc780d8-fa9d-425b-a690-1672d2741506 57955-0028 HUMAN OTC DRUG Migraine Freee Gelsemium sempervirens, Glonoinum, Iris versicolor, Kali carbonicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Sanguinaria canadensis, Secale cornutum, Spigelia Anthelmia, Sulphur, Niccolum metallicum LIQUID ORAL 20150218 UNAPPROVED HOMEOPATHIC King Bio Inc. GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; CLAVICEPS PURPUREA SCLEROTIUM; SPIGELIA ANTHELMIA; SULFUR; NICKEL 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0031_30daab5c-5703-46b0-a6fc-104739b835b5 57955-0031 HUMAN OTC DRUG Sporting Edge Arnica montana, Kali carbonicum, Kali phosphoricum, Lacticum acidum, Natrum phosphoricum, Quebracho, Rhus toxicodendron, Sarcolacticum acidum, Zincum oxydatum LIQUID ORAL 20121023 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; LACTIC ACID, DL-; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; ZINC OXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0032_4489409c-b772-4dc3-808f-20b8e9ef1636 57955-0032 HUMAN OTC DRUG TMJ Jaw Formula Baptisia tinctoria, Calcarea fluorica, Causticum, Hepar sulphuris calcareum, Hypericum perforatum, Ignatia amar, Kalmia latifolia, Nux vomica, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis, Symphytum officinale LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. BAPTISIA TINCTORIA ROOT; CALCIUM FLUORIDE; CAUSTICUM; CALCIUM SULFIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; KALMIA LATIFOLIA LEAF; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; COMFREY ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0033_9b2dbe22-2b97-4836-a55b-9c40f954ee96 57955-0033 HUMAN OTC DRUG TremorPlex Agaricus muscarius, Argentum nitricum, Causticum, Gelsemium sempervirens, Heloderma, Hyoscyamus niger, Manganum aceticum, Mercurius solubilis, Stramonium, Zincum metallicum LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. AMANITA MUSCARIA FRUITING BODY; SILVER NITRATE; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; HELODERMA HORRIDUM VENOM; HYOSCYAMUS NIGER; MANGANESE ACETATE TETRAHYDRATE; MERCURIUS SOLUBILIS; DATURA STRAMONIUM; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0041_9feaa4d6-265a-4414-b288-b105c69870e0 57955-0041 HUMAN OTC DRUG Acne Clear Antimonium tartaricum, Asterias rubens, Ferrum metallicum, Hepar sulphuris calcareum, Kali bromatum, Natrum muriaticum, Sanguinaria canadensis, Selenium metallicum, Sepia, Silica, Sulphur, Thuja occidentalis LIQUID ORAL 20140521 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY POTASSIUM TARTRATE; ASTERIAS RUBENS; IRON; CALCIUM SULFIDE; POTASSIUM BROMIDE; SODIUM CHLORIDE; SANGUINARIA CANADENSIS ROOT; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0042_11b88386-dcc9-4c92-86b8-b6c96072b375 57955-0042 HUMAN PRESCRIPTION DRUG Allergies Food Chemicals Allium sativum, Anacardium orientale, Apis mellifica, Gambogia, Mercurius solubilis, Natrum carbonicum, Nitricum acidum, Nux vomica, Phosphorus, Pulsatilla, Sulphur LIQUID ORAL 20130201 UNAPPROVED HOMEOPATHIC King Bio Inc. GARLIC; SEMECARPUS ANACARDIUM JUICE; APIS MELLIFERA; GAMBOGE; MERCURIUS SOLUBILIS; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 57955-0043_865a4797-3e4d-4375-903c-dc19641bc218 57955-0043 HUMAN OTC DRUG Allergy Hay Fever Reliever Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, arum triphyllum, Arundo mauritanica, Euphrasia officinalis, Naphthalinum, Natrum muriaticum, Sabadilla, Wyethia helenioides LIQUID ORAL 20160518 UNAPPROVED HOMEOPATHIC King Bio Inc. ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; EUPHRASIA STRICTA; NAPHTHALENE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; WYETHIA HELENIOIDES ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0044_9d3f96c6-ce6e-45c6-b985-09b45b4a91da 57955-0044 HUMAN OTC DRUG Asthma Clear Adrenalinum, Antimonium tartaricum, Aralia racemosa, Arsenicum album, Eriodictyon californicum, Eucalyptus globulus, Grindelia, Ipecacuanha, Lobelia inflata, Natrum sulphuricum, Quebracho LIQUID ORAL 20110519 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; GRINDELIA SQUARROSA WHOLE; IPECAC; LOBELIA INFLATA; SODIUM SULFATE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0049_29c1571e-3875-49c7-9dc5-58f2f5539684 57955-0049 HUMAN OTC DRUG Hair and Nails Formula Adrenalinum, Antimonium crudum, Arsenicum album, Natrum muriaticum, Phosphoricum acidum, Phosphorus, Pix liquid, Selenium metallicum, Silicea, Sulphur, Thuja occidentalis LIQUID ORAL 20121023 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; SODIUM CHLORIDE; PHOSPHORIC ACID; PHOSPHORUS; PINE TAR; SELENIUM; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0052_7b8ab15a-b006-439a-a2e1-e695740b8165 57955-0052 HUMAN OTC DRUG Urinary Tract Infections Apis mellifica, Argentum nitricum, Berberis vulgaris, Cantharis, Cuprum arsenicosum, Equisetum hyemale, Lycopodium clavatum, Mercurius corrosivus, Oxalicum acidum, Plumbum metallicum, Sarsaparilla, Terebinthina LIQUID ORAL 20140521 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; CUPRIC ARSENITE; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; OXALIC ACID DIHYDRATE; LEAD; SMILAX REGELII ROOT; TURPENTINE OIL 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0053_f9cc6254-2dfe-40c9-a8aa-a21e6edc732e 57955-0053 HUMAN OTC DRUG Lungs and Bronchial Relief Ammonium carbonicum, Antimonium arsenicicum, Antimonium tartaricum, Arsenicum album, Bromium, Carbo vegetabilis, Chlorinum, Kali carbonicum, Lobelia inflata, Stannum metallicum, Sulphuricum acidum LIQUID ORAL 20140505 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CARBONATE; ANTIMONY ARSENATE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BROMINE; ACTIVATED CHARCOAL; CHLORINE; POTASSIUM CARBONATE; LOBELIA INFLATA; TIN; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0055_71ace0c1-dd3e-4720-9eb8-bd1b030ec962 57955-0055 HUMAN OTC DRUG Nausea and Motion Sickness Argentum nitricum, Bryonia, Cocculus indicus, Glonoinum, Lac defloratum, Petroleum, Staphysagria, Tabacum LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC King Bio Inc. SILVER NITRATE; BRYONIA ALBA ROOT; ANAMIRTA COCCULUS SEED; NITROGLYCERIN; SKIM MILK; KEROSENE; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0058_9e40b672-7c31-4700-9191-4ae3d0b22d6f 57955-0058 HUMAN OTC DRUG Sore Throat and Laryngitis Aconitum napellus, Antimonium crudum, Arum triphyllum, Borax, Causticum, Ferrum phosphoricum, Graphites, Hepar sulphuris calcareum, Kali bichromicum, Phosphorus, Selenium metallicum, Spongia tosta LIQUID ORAL 20150218 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARISAEMA TRIPHYLLUM ROOT; SODIUM BORATE; CAUSTICUM; FERROSOFERRIC PHOSPHATE; GRAPHITE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; PHOSPHORUS; SELENIUM; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0059_5a1176dd-e251-4024-9527-d5f96568c5a5 57955-0059 HUMAN OTC DRUG Wart Freee Antimonium crudum, Causticum, Dulcamara, Kali muriaticum, Nitricum acidum, Sabina, Staphysagria, Sulphur, Thuja occidentalis LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; CAUSTICUM; SOLANUM DULCAMARA TOP; POTASSIUM CHLORIDE; NITRIC ACID; JUNIPERUS SABINA LEAFY TWIG; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0061_614ead7c-3a75-429f-95b5-a1557d68ba26 57955-0061 HUMAN OTC DRUG Blood and Kidney Detox Arsenicum album, baptisia tinctoria, Carbo vegetabilis, Chininum sulphuricum, Cinchona officinalis, Conium maculatum, Echinacea purpurea, Ferrum metallicum, Hydrastis canadensis, Kali chloricum, Mercurius corrosivus, Serum anguillae LIQUID ORAL 20150218 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ACTIVATED CHARCOAL; QUININE SULFATE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; IRON; GOLDENSEAL; POTASSIUM CHLORATE; MERCURIC CHLORIDE; ANGUILLA ROSTRATA BLOOD SERUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0062_b55112ea-5790-4d63-86d5-c668b3b752da 57955-0062 HUMAN OTC DRUG Liver Detox Arsenicum album, Baptisia tinctoria, Barberis vulgaris, Bryonia, Carduus marianus, Chelidonium majus, Chionanthus virginica, Cinchona officinalis, Lycopodium clavatum, Magnesia muriatica, Natrum sulphuricum, Nux vomica, Phosphorus, Sulphur, Taraxacum officinale LIQUID ORAL 20121203 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; MILK THISTLE; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SULFUR; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0063_1b7ace10-bd1e-44d6-99b5-743abef10708 57955-0063 HUMAN OTC DRUG Lymph Detox Belladonna, Calcarea lodata, Conium maculatum, Echinacea purpurea, Hepar sulphuris calcareum, Kali iodatum, Kali muriaticum, Mercurius vivus, Phytolacca decandra, Pulsatilla, Ricinus communis, Scrophularia nodosa, Solidago virgaurea, Sulphur iodatum LIQUID ORAL 20121203 UNAPPROVED HOMEOPATHIC King Bio Inc. ATROPA BELLADONNA; CALCIUM IODIDE; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; CALCIUM SULFIDE; POTASSIUM IODIDE; POTASSIUM CHLORIDE; MERCURY; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RICINUS COMMUNIS SEED; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR IODIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0064_c0dde618-7891-46dd-aee3-50baf117b269 57955-0064 HUMAN OTC DRUG Artery/Cholesterol/BP Aurum metallicum, Aurum muriaticum natronatum, Baryta carbonica, Baryta muriatica, Calcarea fluorica, Ceanothus americanus, Cholesterinum, Glonoinum, Plumbum iodatum, Strophanthus hispidus LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. GOLD; SODIUM TETRACHLOROAURATE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CALCIUM FLUORIDE; CEANOTHUS AMERICANUS LEAF; CHOLESTEROL; NITROGLYCERIN; LEAD IODIDE; STROPHANTHUS HISPIDUS SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0065_10cf2ef3-2b83-4574-8dea-56dea9c8d39b 57955-0065 HUMAN OTC DRUG Heart Regularity Apocynum cannabinum, Baryta carbonica, Cactus grandiflorus, Convallaria majalis, Digitalis purpurea, Gelsemium sempervirens, Glonoinum, Naja tripudians, Phosphorus, Spigelia anthelmia, Spongia tosta LIQUID ORAL 20140513 UNAPPROVED HOMEOPATHIC King Bio Inc. APOCYNUM CANNABINUM ROOT; BARIUM CARBONATE; SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; NAJA NAJA VENOM; PHOSPHORUS; SPIGELIA ANTHELMIA; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0066_175e680a-f421-4d1b-923f-c376b216821a 57955-0066 HUMAN OTC DRUG VeinoPlex Aesculus hippocastanum, Arnica montana, Calcarea fluorica, Carbo vegetabilis, Carduus marianus, Collinsonia canadensis, Echinacea purpurea, Hamamelis virginiana, Lachesis mutus, Pulsatilla, Secale cornutum LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC King Bio Inc. HORSE CHESTNUT; ARNICA MONTANA; CALCIUM FLUORIDE; ACTIVATED CHARCOAL; MILK THISTLE; COLLINSONIA CANADENSIS ROOT; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0067_0b4748b2-675e-46ea-8c04-be5109e0f1cb 57955-0067 HUMAN OTC DRUG ApoPlex Arnica montana, Belladonna, Calendula officinalis, Causticum, Cocculus indicus, Gloninum, Lachesis mutus, Plumbum metallicum LIQUID ORAL 20120723 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; ANAMIRTA COCCULUS SEED; NITROGLYCERIN; LACHESIS MUTA VENOM; LEAD 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0068_075673dd-d7cb-4a26-ba2c-aa3d7122d03d 57955-0068 HUMAN OTC DRUG Gallplex Berberis vulgaris, Bryonia, Carduus marianus, Chelidonium majus, Cholesterinum, Cinchona officinalis, Colocynthis, Dioscorea villosa, Lycopodium clavatum, Natrum sulphuricum LIQUID ORAL 20140718 UNAPPROVED HOMEOPATHIC King Bio Inc. BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; MILK THISTLE; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0069_1d76afd9-b204-49e7-931d-aa22e777ace5 57955-0069 HUMAN OTC DRUG LymePlex Baptisia tinctoria, Belladonna, Byronia, Calcarea carbonica, Calcarea fluorica, Eupatorium perfoliatum, Gelsemium sempervirens, Kali carbonicum, Mercurius vivus, Rhus toxicodendron LIQUID ORAL 20150218 UNAPPROVED HOMEOPATHIC King Bio Inc. BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM CARBONATE; MERCURY; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0070_3213d9dc-c816-48ed-8bc3-6744c29bbab2 57955-0070 HUMAN OTC DRUG Bone Strengthener Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Equisetum hyemale, Hekla lava, Phosphorus, silicea LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; EQUISETUM HYEMALE; HEKLA LAVA; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0071_9604d35a-d3b2-4745-8c4c-9fae63720d68 57955-0071 HUMAN OTC DRUG ChemoClenz Arsenicum album, Cadmium sulphuricum, Ipecacuanha, Nux vomica, Phosphoricum acidum, Phosphorus, Strontium carbonicum, Tabacum, Uranium nitricum LIQUID ORAL 20150218 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; CADMIUM SULFATE; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; STRONTIUM CARBONATE; TOBACCO LEAF; URANYL NITRATE HEXAHYDRATE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0072_bee7b72c-1f5c-4bc7-9f7d-62592f4a6e69 57955-0072 HUMAN OTC DRUG Sugar Metabolizer Aceticum acidum, Arsenicum album, Bryonia, Calcarea carbonica, Iris versicolor, Kali phosphoricum, Lacticum acidum, Lycopodium clavatum, Natrum phosphoricum, Phosphoricum acidum, Phosphorus, Plumbum metallicum, Uranium nitricum LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IRIS VERSICOLOR ROOT; POTASSIUM PHOSPHATE, DIBASIC; LACTIC ACID, DL-; LYCOPODIUM CLAVATUM SPORE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PHOSPHORIC ACID; PHOSPHORUS; LEAD; URANYL NITRATE HEXAHYDRATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0073_71ab1b01-63dd-42a5-9b9a-f3d877f6a1ed 57955-0073 HUMAN OTC DRUG Teeth and Gum Formula Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Chamomilla, Coccinella septempunctata, Coffea cruda, Hekla lava, Hypericum perforatum, Kreosotum, Ledum palustre, Magnesia phosphorica, Mercurius vivus LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC King Bio Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; COCCINELLA SEPTEMPUNCTATA; ARABICA COFFEE BEAN; HEKLA LAVA; HYPERICUM PERFORATUM; WOOD CREOSOTE; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURY 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0074_d12c6c7b-c35d-4406-b9d4-432558a4675e 57955-0074 HUMAN OTC DRUG UlcerPlex Anacardium orientale, Argentum nitricum, Arsenicum album, Atropinum, Carbo vegetabilis, Geranium maculatum, Kali bichromicum, Ornithogalum umbellatum, Uranium nitricum LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPINE; ACTIVATED CHARCOAL; GERANIUM MACULATUM ROOT; POTASSIUM DICHROMATE; ORNITHOGALUM UMBELLATUM; URANYL NITRATE HEXAHYDRATE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0076_99db1291-1eaf-4ab9-a191-e86706b4bd97 57955-0076 HUMAN PRESCRIPTION DRUG Yeast Freee Abies nigra, Antimonium crudum, Asafoetida, Baptisia tinctoria, Borax, Candida albicans, Lachesis mutus, Phosphoricum acidum, Phytolacca decandra, Pulsatilla, Sticta Plumonaria, Sulphur, Thuja occidentalis LIQUID ORAL 20130226 UNAPPROVED HOMEOPATHIC King Bio Inc. PICEA MARIANA RESIN; ANTIMONY TRISULFIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; SODIUM BORATE; CANDIDA ALBICANS; LACHESIS MUTA VENOM; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; LOBARIA PULMONARIA; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 57955-0077_d8219764-299b-4954-8e9e-6b96c2c6d38a 57955-0077 HUMAN OTC DRUG Bug Away Apis mellifica, Cistus canadensis, Citricum acidum, Hypericum perforatum, Kali nitricum, Ledum palustre, Lycopodium clavatum, Mezereum, Pulex irritans, Pulsatilla, Staphysagria, Sulphur, Urtica urens LIQUID ORAL 20120723 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; HELIANTHEMUM CANADENSE; ANHYDROUS CITRIC ACID; HYPERICUM PERFORATUM; POTASSIUM NITRATE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; PULEX IRRITANS; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; SULFUR; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0081_5a4b2f45-0da4-427a-9c60-21a19940d053 57955-0081 HUMAN PRESCRIPTION DRUG Acute Viro Reliever Aconitum napellus, Belladonna, Chininum sulphuricum, Ferrum phosphoricum, Hepar sulphuris calcareum, Mercurius corrosivus, Natrum muriaticum, Nux vomica, Phosphorus, Pulsatilla, Sarcolacticum acidum, Sulphur LIQUID ORAL 20121212 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; QUININE SULFATE; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; MERCURIC CHLORIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; LACTIC ACID, L-; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Antimalarial [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 57955-0082_f81a6b32-6499-4855-aa05-760a95955b47 57955-0082 HUMAN OTC DRUG VaccinoClenz Aconitum napellus, Apis mellifica, Chamomilla, Hypericum perforatum, Ledum palustre, Pulsatilla, silicea, Thuja occidentalis LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0085_186fd631-4155-48b0-9f77-1efa9f6a7b00 57955-0085 HUMAN OTC DRUG No Sweat Anti-Perspirant Antimonium tartaricum, Calcarea carbonica, Cinchona officinalis, Mercurius solubilis, Mercurius vivus, Pilocarpus, Phosphoricum acidum, Sambucus nigra, Silicea, Sulphuricum acidum LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY POTASSIUM TARTRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CINCHONA OFFICINALIS BARK; MERCURIUS SOLUBILIS; MERCURY; PILOCARPUS JABORANDI LEAF; PHOSPHORIC ACID; SAMBUCUS NIGRA FLOWERING TOP; SILICON DIOXIDE; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0087_efe78c58-2f92-4f61-8e0f-bab8a7fa05c3 57955-0087 HUMAN OTC DRUG ScarCure Arnica montana, Calcarea fluorica, Calcarea phosphorica, Calendula officinalis, Graphites, Hydrofluoricum acidum, Phytolacca decandra, Sabina, Silicea, Thiosinaminum, Thuja occidentalis LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; HYDROFLUORIC ACID; PHYTOLACCA AMERICANA ROOT; JUNIPERUS SABINA LEAFY TWIG; SILICON DIOXIDE; ALLYLTHIOUREA; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0088_d225cdf8-6cf9-40f5-bb22-6c2a5880bf05 57955-0088 HUMAN OTC DRUG Chronic Viro Reliever Boletus luridus, Bryonia, Crotalus horridus, Echinacea purpurea, Gelsemium sempervirens, Gentiana lutea, Kali phosphoricum, Lachesis mutus, Mercurius vivus, Muriaticum acidum, Natrum sulphuricum, Nitricum acidum, Phosphoricum acidum, Veratrum album LIQUID ORAL 20140328 UNAPPROVED HOMEOPATHIC King Bio Inc. BOLETUS LURIDUS FRUITING BODY; BRYONIA ALBA ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA PURPUREA; GELSEMIUM SEMPERVIRENS ROOT; GENTIANA LUTEA ROOT; POTASSIUM PHOSPHATE, DIBASIC; LACHESIS MUTA VENOM; MERCURY; HYDROCHLORIC ACID; SODIUM SULFATE; NITRIC ACID; PHOSPHORIC ACID; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0094_ebae2ebd-7319-449d-b4ac-164687ff4f3a 57955-0094 HUMAN OTC DRUG Bladder Formula Aesculus hippocastanum, apis mellifica, Benzoicum acidum, Causticum, Equisetum hyemale, Lycopodium clavatum, Phosphorus, Plantago major, Rhus aromatica, Sepia LIQUID ORAL 20140430 UNAPPROVED HOMEOPATHIC King Bio Inc. HORSE CHESTNUT; APIS MELLIFERA; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0095_42c413d9-4a30-44df-a39b-586ce7716ca6 57955-0095 HUMAN OTC DRUG PMS Relief Apis mellifica, Chamomilla, Cimicifuga racemosa, Cyclamen europaeum, Helonias dioica, Hypericum perforatum, Hypothalamus, Ignatia amara, Kali carbonicum, Lac caninum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Oophorinum, Platinum metallicum, Sepia LIQUID ORAL 20140611 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; MATRICARIA RECUTITA; BLACK COHOSH; CYCLAMEN PURPURASCENS TUBER; CHAMAELIRIUM LUTEUM ROOT; HYPERICUM PERFORATUM; BOS TAURUS HYPOTHALAMUS; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; CANIS LUPUS FAMILIARIS MILK; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA OVARY; PLATINUM; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0098_16bc47fe-c5db-422d-ae96-9920285621ba 57955-0098 HUMAN OTC DRUG ICV Clenz Antimonium crudum, Arsenicum album, Cinchona officinalis, Colocynthis, Gambogia, Gentiana lutea, Magnesia phosphorica, Natrum sulphuricum, Nux vomica, Phosphorus LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; GAMBOGE; GENTIANA LUTEA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0100_b12434ff-89b9-4c7e-9872-584118948066 57955-0100 HUMAN OTC DRUG Hydration Aloe socotrina, Apis mellifica, Avena sativa, Carbo vegetabilis, Equisetum hyemale, Gelsemium sempervirens, Pulsatilla, Selenium metallicum, Taraxacum officinale LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; ACTIVATED CHARCOAL; EQUISETUM HYEMALE; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS; SELENIUM; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0101_b21a299f-6d0e-4478-bda3-c6ad7d629998 57955-0101 HUMAN OTC DRUG Acute Viro Reliever Aconitum napellus, Belladonna, Chininum sulphuricum, Ferrum phosphoricum, Hepar sulphuris calcareum, Mercurius corrosivus, Natrum muriaticum, Nux vomica, Phosphorus, Pulsatilla, Sarcolacticum acidum, Sulphur LIQUID ORAL 20140402 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; QUININE SULFATE; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; MERCURIC CHLORIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; LACTIC ACID, L-; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0102_cd5dc274-1dc1-4790-8461-c25adfbf1052 57955-0102 HUMAN OTC DRUG Yeast Freee Abies nigra, Antimonium crudum, Asafoetida, Baptisia tinctoria, Borax, Candida albicans, Lachesis mutus, Phosphoricum acidum, Phytolacca decandra, Pulsatilla, Sticta pulmonaria, sulphur, thuja occidentalis LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. PICEA MARIANA RESIN; ANTIMONY TRISULFIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; SODIUM BORATE; CANDIDA ALBICANS; LACHESIS MUTA VENOM; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; LOBARIA PULMONARIA; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 12; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0112_23d704ef-a6cf-41d0-80cf-beb43804a971 57955-0112 HUMAN OTC DRUG CataCure Calcarea carbonica, Calcarea fluorica, Causticum, Cineraria maritima, Euphrasia officinalis, Naphthalinum, Natrum muriaticum, Phosphorus, Quassia amara, Silicea LIQUID ORAL 20150901 UNAPPROVED HOMEOPATHIC King Bio Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; JACOBAEA MARITIMA; EUPHRASIA STRICTA; NAPHTHALENE; SODIUM CHLORIDE; PHOSPHORUS; QUASSIA AMARA WOOD; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0113_c4f80e1e-e405-4ceb-85e7-94abb1732618 57955-0113 HUMAN OTC DRUG Hangover Relief Arsenicum album, Asarum europaeum, Avena sativa, Bryonia, Capsicum annuum, Carbo vegetabilis, Carboneum sulphuratum, Cinchona officinalis, Gelsemium sempervirens, Nux vomica, Paullinia sorbilis, Sulphuricum acidum LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; ASARUM EUROPAEUM; AVENA SATIVA FLOWERING TOP; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; CARBON DISULFIDE; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; PAULLINIA CUPANA SEED; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0114_9e761078-260c-46dd-b204-dc1f31435ee3 57955-0114 HUMAN OTC DRUG Newborn Tonic Aconitum napellus, Bovista, Bryonia, Chamomilla, Cinchona officinalis, Lupulinum, Mercurius vivus, Myrica cerifera, Natrum sulphuricum, Phosphorus, Sepia LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; LYCOPERDON UTRIFORME FRUITING BODY; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; HOPS; MERCURY; MORELLA CERIFERA ROOT BARK; SODIUM SULFATE; PHOSPHORUS; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0115_62ad50d4-ff03-4732-bf13-1c5374f0c150 57955-0115 HUMAN OTC DRUG Female Enhancer Agnus castus, Aletris farinosa, Berberis vulgaris, Caulophyllum thalictroides, Ferrum metallicum, Graphites, Helonias dioica, Ignatia amara, Lilium tigrinum, Lycopodium clavatum, Natrum muriaticum, Onosmodium virginianum, Pulsatilla, Sepia LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. CHASTE TREE; ALETRIS FARINOSA ROOT; BERBERIS VULGARIS ROOT BARK; CAULOPHYLLUM THALICTROIDES ROOT; IRON; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; ONOSMODIUM VIRGINIANUM WHOLE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0116_b551e41d-8db7-4e70-aa64-b3bbe3298a94 57955-0116 HUMAN OTC DRUG Poison Ivy and Oak Relief Anacardium occidentale, clematis erecta, Croton tiglium, Cypripedium pubescens, Echinacea purpurea, Erechtites hieracifolia, Graphites Grindelia, Histaminum hydrochloricum, Mezereum, Rhus toxicodendron, Urtica urens LIQUID ORAL 20140527 UNAPPROVED HOMEOPATHIC King Bio Inc. ANACARDIUM OCCIDENTALE FRUIT; CLEMATIS RECTA FLOWERING TOP; CROTON TIGLIUM SEED; CYPRIPEDIUM PARVIFOLUM ROOT; ECHINACEA PURPUREA; ERECHTITES HIERACIIFOLIUS; GRAPHITE; GRINDELIA HIRSUTULA WHOLE; HISTAMINE DIHYDROCHLORIDE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0117_c026d0af-5294-4775-a5c6-1685f8ae94ed 57955-0117 HUMAN OTC DRUG Bactero Reliever Allium sativum, Arsenicum album, Baptisia tinctoria, Belladonna, Echinacea purpurea, Eucalyptus globulus, Hydrastis canadensis, Lac caninum, Myristica sebifera, Myrtus communis, Phosphorus, Phytolacca decandra LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. GARLIC; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; GOLDENSEAL; CANIS LUPUS FAMILIARIS MILK; VIROLA SEBIFERA RESIN; MYRTUS COMMUNIS TOP; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0118_03fe8a76-4c0c-4a36-8799-24889125138c 57955-0118 HUMAN OTC DRUG Wounds Recovery Arnica montana, Bellis perennis, Bryonia, Calendula officinalis, Carbo vegetabilis, Hamamelis virginiana, Hepar sulphuris calcareum, Hypericum perforatum, Millefolium, Rhus toxicodendron, Staphysagria, Symphytum officinale, Veratrum album LIQUID ORAL 20140528 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ACTIVATED CHARCOAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; TOXICODENDRON PUBESCENS LEAF; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0120_6ae1fe53-10e4-43e8-9179-36ed91c42e72 57955-0120 HUMAN OTC DRUG Snore Control Bromium, Chamomilla, Cinchona officinalis, Cuprum metallicum,Helleborus niger, Laurocerasus, Nux vomica, Phosphoricum acidum, Rhus toxicodendron, Silicea, Stramonium, Zincum metallicum LIQUID ORAL 20121203 UNAPPROVED HOMEOPATHIC King Bio Inc. BROMINE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COPPER; HELLEBORUS NIGER ROOT; PRUNUS LAUROCERASUS LEAF; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; DATURA STRAMONIUM; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0121_612af33c-83de-4480-a065-d8e4840bd1e8 57955-0121 HUMAN OTC DRUG Swollen Glands Relief Astacus fluviatilis, Baryta iodata, Calcarea iodata, Cistus canadensis, clematis erecta, Conium maculatum, Iodium, Lacticum acidum, Mercurius iodatus ruber, Mercurius vivus, Phytolacca decandra, Scrophularia nodosa, Spongia tosta LIQUID ORAL 20150821 UNAPPROVED HOMEOPATHIC King Bio Inc. ASTACUS ASTACUS; BARIUM IODIDE; CALCIUM IODIDE; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; IODINE; LACTIC ACID, DL-; MERCURIC IODIDE; MERCURY; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0125_cd748c62-034c-44af-b2fd-01dc0d0bdfb0 57955-0125 HUMAN OTC DRUG Stye Freee Apis mellifica, Calcarea picrata, Graphites, Hepar sulphuris calcareum, Juglans regia, Lycopodium clavatum, Pulsatilla, Silicea, Staphysagria, Sulphur, Thuja occidentalis LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; CALCIUM PICRATE; GRAPHITE; CALCIUM SULFIDE; JUGLANS REGIA FRUIT RIND, IMMATURE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0126_b03eecf3-a213-434c-a44f-09b408c6ed2f 57955-0126 HUMAN OTC DRUG Bio Reset/Jet Lag Cocculus indicus, Colchicum autumnale, gelsemium sempervirens, Juniperus communis, Kali carbonicum, Kali phosphoricum, Nux vomica, Passiflora incarnata, Phosphoricum acidum, Phosphorus LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; PHOSPHORUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0127_2a8fe85f-7830-47cb-b015-47f8686bd6d6 57955-0127 HUMAN OTC DRUG Acid Clenz Argentum nitricum, Calcarea carbonica, Calcarea silicate, Calcarea sulphurica, Carbo vegetabilis, Natrum carbonicum, Natrum phosphoricum, Nux vomica, Robinia pseudoacacia, Sulphuricum acidum LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM SILICATE; CALCIUM SULFATE ANHYDROUS; ACTIVATED CHARCOAL; SODIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0128_b064216f-0cc3-4b6e-9a6f-644c3baee7ed 57955-0128 HUMAN OTC DRUG Appetite Enhancer Alumina, Antimonium crudum, Arsenicum album, asarum europaeum, Baptisia tinctoria, Carbolicum acidum, Chininum arsenicosum, Cocculus indicus, Lecithin, Picricum acidum, Pulsatilla, Rhus toxicodendron, Silicea, Sulphur LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; BAPTISIA TINCTORIA ROOT; PHENOL; QUININE ARSENITE; ANAMIRTA COCCULUS SEED; EGG PHOSPHOLIPIDS; PICRIC ACID; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0129_21aead06-e8d6-4189-8be7-b111be632c2e 57955-0129 HUMAN OTC DRUG Athletes Foot Fighter Alumina, Anatherum muricatum, Apis mellifica, Arsenicum album, Butyricum acidum, Hydrocotyle asiatica, Mezereum, Petroleum, Rhus toxicodendron, Sepia, Silicea, Sulphur LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; CHRYSOPOGON ZIZANIOIDES ROOT; APIS MELLIFERA; ARSENIC TRIOXIDE; BUTYRIC ACID; CENTELLA ASIATICA; DAPHNE MEZEREUM BARK; KEROSENE; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0130_00d8bea9-cc6d-4fbf-9ae4-a221236e9b6f 57955-0130 HUMAN OTC DRUG Odor Freee Baptisia tinctoria, Carbo animalis, Guaiacum, Lycopodium clavatum, Mercurius solubilis, Nitricum acidum, Petroleum, Sepia, Silicea, Sulphur, Thuja occidentalis LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC King Bio Inc. BAPTISIA TINCTORIA ROOT; CARBO ANIMALIS; GUAIACUM OFFICINALE RESIN; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; KEROSENE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0131_e8a85e53-2701-480e-a617-e456af964009 57955-0131 HUMAN OTC DRUG Calcium Metabolizer Calcarea acetica, Calcarea carbonica, Calcarea caustica, Calcarea fluorica, Calcarea iodata, Calcarea lactica, Calcarea muriatica, Calcarea oxalica, Calcarea phosphorica, Calcarea silicata, Calcarea sulphurica, Hekla lava, Silicea LIQUID ORAL 20150220 UNAPPROVED HOMEOPATHIC King Bio Inc. CALCIUM ACETATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM HYDROXIDE; CALCIUM FLUORIDE; CALCIUM IODIDE; CALCIUM LACTATE PENTAHYDRATE; CALCIUM CHLORIDE; CALCIUM OXALATE MONOHYDRATE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SILICATE; CALCIUM SULFATE ANHYDROUS; HEKLA LAVA; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0133_7dda770b-f8e5-4f21-b2c4-f0d20ac6119d 57955-0133 HUMAN OTC DRUG Muscle Maximizer Adrenalinum, Alfalfa, Avena sativa, Baryta carbonica, Baryta lodata, Baryta muriatica, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Lycopodium clavatum, Thuja occidentalis LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; ALFALFA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; BARIUM IODIDE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0134_d48085d9-9992-41f6-ac86-2b6d3af377d9 57955-0134 HUMAN OTC DRUG Sinus Relief Apis mellifica, Baptisia tinctoria, Colocynthis, Hepar sulphuris calcareum, Histaminum hydrochloricum, Hydrastis canadensis, Ignatia amara, Kali bichromicum, Lemna minor, Mercurius vivus, Pulsatilla, Rhus toxicodendron, Sabadilla, Thuja occidentalis LIQUID ORAL 20131217 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LEMNA MINOR; MERCURY; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0140_9a2d103e-6261-457a-b69f-e302e1d47ebd 57955-0140 HUMAN OTC DRUG Nosebleed Relief Ambrosia artemisiaefolia, Arnica montana, Bovista, Bryonia, Carbo vegetabilis, Ferrum Phosporicum, Hamamelis virginian, Ipecacuanha, Mercurius vivus, Nitricum acidum, Phosphorus, Trillium pendulum LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. AMBROSIA ARTEMISIIFOLIA; ARNICA MONTANA; LYCOPERDON UTRIFORME FRUITING BODY; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; FERROSOFERRIC PHOSPHATE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; IPECAC; MERCURY; NITRIC ACID; PHOSPHORUS; TRILLIUM ERECTUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0142_152b927b-7f07-4f5a-9027-c299642b520b 57955-0142 HUMAN PRESCRIPTION DRUG Childrens Growth and Development Alfalfa, Avena sativa, Baryta carbonica, Baryta iodata, Baryta muriatica, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Lycopodium clavatum and Thuja occidentalis LIQUID ORAL 20130228 UNAPPROVED HOMEOPATHIC King Bio Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; BARIUM IODIDE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 57955-0145_b7c1743c-3321-4a9f-bdeb-abb1f224fc83 57955-0145 HUMAN OTC DRUG Childrens Cough Aconitum napellus, Bromium, Coccus cacti, Corallium rubrum, Cuprum metallicum, Drosera, Hepar sulphuris calcareum, Iodium, Mephitis mephitica, Spongia tosta LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BROMINE; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; COPPER; DROSERA ROTUNDIFOLIA; CALCIUM SULFIDE; IODINE; MEPHITIS MEPHITIS ANAL GLAND FLUID; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0146_c5c9f909-a102-441f-917f-001207369f6c 57955-0146 HUMAN OTC DRUG Tummy Aches Argentum nitricum, Bryonia, Cocculus indicus, Glonoinum, Lac defloratum, Petroleum, Staphysagria, Tabacum LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. SILVER NITRATE; BRYONIA ALBA ROOT; ANAMIRTA COCCULUS SEED; NITROGLYCERIN; SKIM MILK; KEROSENE; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0148_c40af21f-8949-49ac-a5c9-28e4edd6288d 57955-0148 HUMAN OTC DRUG Childrens Growth and Development Alfalfa, Avena sativa, Baryta carbonica, Baryta iodata, Baryta muriatica, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Lycopodium clavatum, Thuja occidentalis. LIQUID ORAL 20170308 UNAPPROVED HOMEOPATHIC King Bio, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; BARIUM IODIDE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0149_05fa4d91-b6a6-4e5f-a8b5-4b3e18748877 57955-0149 HUMAN OTC DRUG Constitutional Enhancer Aconitum napellus, Arsenicum album, Baryta carbonica, Bryonia, Calcarea carbonica, Cantharis, Gelsemium sempervirens, Graphites, Hydrastis canadensis, Kali iodatum, Lachesis mutus, Lycopodium clavatum, Mercurius vivus, natrum muriaticum, nux vomica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhus toxicodendon, Sepia, Silicea, Sulphur LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYTTA VESICATORIA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; GOLDENSEAL; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0151_5482bbb2-0abf-49f8-965c-f380870ec4db 57955-0151 HUMAN OTC DRUG Eye Stress Agaricus muscarius, Argentum nitricum, Calcarea carbonica, Carbo vegetabilis, Gelsemium sempervirens, Graphites, Mephitis mephitica, Natrum muriaticum, Onosmodium virginianum, Phosphorus, Physostigma venenosum, Pilocarpus LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. AMANITA MUSCARIA FRUITING BODY; SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; MEPHITIS MEPHITIS ANAL GLAND FLUID; SODIUM CHLORIDE; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; PILOCARPUS JABORANDI LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0153_63f0a95c-a736-45d4-98e9-65357fa0195b 57955-0153 HUMAN OTC DRUG Headache Freee Belladonna, Bryonia, Capsicum annuum, Chininum arsenicosum, Coffea cruda, Gelsemium sempervirens, Glonoinum, Ignatia amara, Kali bichromicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia, Sulphur LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; QUININE ARSENITE; ARABICA COFFEE BEAN; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0154_baef6246-0387-4ce4-8815-d5719186bf50 57955-0154 HUMAN OTC DRUG Ear Relief Formula Aconitum napellus, Allium cepa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, Silicea LIQUID ORAL 20150218 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ONION; APIS MELLIFERA; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CAUSTICUM; MATRICARIA RECUTITA; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM CHLORIDE; CALOMEL; MERCURIUS SOLUBILIS; PLANTAGO MAJOR; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0158_a917c46b-69f7-4314-bd78-de8703188096 57955-0158 HUMAN OTC DRUG Colic Relief Aethusa cynapium, Alumina, Belladonna, Borax, Chamomilla, Colocynthis, Dioscorea villosa, Ipecacuanha, Magnesia phosphorica, Natrum phosphoricum, Nux vomica, Plumbum metallicum, Pulsatilla, Senna, Silicea, Valeriana officinalis LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC King Bio Inc. AETHUSA CYNAPIUM; ALUMINUM OXIDE; ATROPA BELLADONNA; SODIUM BORATE; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; LEAD; PULSATILLA VULGARIS; SENNA LEAF; SILICON DIOXIDE; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0159_167af674-4640-4c40-b11a-625334598a0d 57955-0159 HUMAN PRESCRIPTION DRUG Childrens Fever Reliever Aceticum acidum, Aconitum napellus, Aesculus hippocastanum, Agaricus muscarius, Baptisia tinctoria, Belladonna, Bryonia, Chamomilla, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Pulsatilla, Rhus toxicodendron, Sambucus nigra, Sulphur, Veratrum Viride LIQUID ORAL 20130301 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; ACONITUM NAPELLUS; HORSE CHESTNUT; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; VERATRUM VIRIDE ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0161_845e5b05-c820-4e09-9762-f51127f81575 57955-0161 HUMAN OTC DRUG Back, Neck, Muscle and Joint Injuries Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cabaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Zincum metallicum LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0162_b33cc5a1-1afc-43c3-9efe-eb89a5bd4010 57955-0162 HUMAN OTC DRUG Arthritis and Joint Relief Actaea spicata, Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Ledum palustre, Lithium carbonicum, Magnesia phosphorica, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus toxicodendron, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTAEA SPICATA ROOT; HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0165_3eb144e7-254b-4836-b9e2-fe383e0cb33b 57955-0165 HUMAN OTC DRUG Colds Sores and Herpes Apis mellifica, Arsenicum album, Borax, Capsicum annuum, Graphites, Mentha piperita, Mezereum, Natrum muriaticum, Nux vomica, Petroleum, Ranunculus bulbosus, Rhus toxicodendron LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc APIS MELLIFERA; ARSENIC TRIOXIDE; SODIUM BORATE; CAPSICUM; GRAPHITE; MENTHA PIPERITA; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; KEROSENE; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0166_3fc45839-f02e-458b-a6b8-12a3b6413e63 57955-0166 HUMAN OTC DRUG Cough Control Aconitum napellus, Bromium, Coccus cacti, Corallium rubrum, Cuprum metallicum, Drosera rotundifolia, Ferrum phosphoricum, Hepar sulphuris calcareum, Iodium, Kali bichromicum, Mephitis mephitica, Nux vomica, Phosphorus, Pulsatilla, Rumex crispus, Sanguinaria canadensis, Spongia tosta, Sulphur LIQUID ORAL 20150722 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BROMINE; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; COPPER; DROSERA ROTUNDIFOLIA; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; IODINE; POTASSIUM DICHROMATE; MEPHITIS MEPHITIS ANAL GLAND FLUID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0168_35711820-825b-49f9-933d-186a7b486b15 57955-0168 HUMAN OTC DRUG Skin Irritations and Itch Relief Arsenicum album, Agaricus muscarius, Alumina, Anagallis arvensis, Antimonium tartaricum, Apis mellifica, Arsenicum lodatum, Bovista, Causticum, Dolichos pruriens, Fagopyrum esculentum, Graphites, Kali muriaticum, Muriaticum acidum, Oleander, Petroleum, Pix liquida, Radium bromatum, Rhus toxicodendron, Selenium metallicum, Sulphur, Urtica urens LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; AMANITA MUSCARIA FRUITING BODY; ALUMINUM OXIDE; ANAGALLIS ARVENSIS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARSENIC TRIIODIDE; LYCOPERDON UTRIFORME FRUITING BODY; CAUSTICUM; MUCUNA PRURIENS FRUIT TRICHOME; FAGOPYRUM ESCULENTUM; GRAPHITE; POTASSIUM CHLORIDE; HYDROCHLORIC ACID; NERIUM OLEANDER LEAF; KEROSENE; PINE TAR; RADIUM BROMIDE; TOXICODENDRON PUBESCENS LEAF; SELENIUM; SULFUR; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0170_cf2df145-9e8e-42b4-9423-fe51019cc736 57955-0170 HUMAN OTC DRUG Climate Adaptation Cold and Damp Aranea diadema, Calcarea carbonica, Carbo animalis, Dulcamara, Formica rufa, Hypericum perforatum, Hypothalamus, Nux moschata, Oleum morrhuae, Phytolacca decandra, Polygonum punctatum, Sanguinaria canadensis, Thyroidinum, Urtica urens, Veratrum album LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC King Bio Inc. ARANEUS DIADEMATUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARBO ANIMALIS; SOLANUM DULCAMARA TOP; FORMICA RUFA; HYPERICUM PERFORATUM; BOS TAURUS HYPOTHALAMUS; NUTMEG; COD LIVER OIL; PHYTOLACCA AMERICANA ROOT; PERSICARIA PUNCTATA; SANGUINARIA CANADENSIS ROOT; THYROID, UNSPECIFIED; URTICA URENS; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0172_37ae5a4f-d616-40d8-b537-7547f67e9b7c 57955-0172 HUMAN OTC DRUG Climate Adaptation Hot and Dry Antimonium crudum, Baptisia tinctoria, Chamomilla, Fagopyrum esculentum, Glonoinum, Hypothalamus, Natrum carbonicum, Natrum muriaticum, Podophyllinum, Populus candicans, Selenium metallicum, Thyroidinum LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; BAPTISIA TINCTORIA ROOT; MATRICARIA RECUTITA; FAGOPYRUM ESCULENTUM; NITROGLYCERIN; BOS TAURUS HYPOTHALAMUS; SODIUM CARBONATE; SODIUM CHLORIDE; PODOPHYLLUM RESIN; POPULUS BALSAMIFERA LEAF BUD; SELENIUM; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0173_8bdda7ac-ce6e-4c73-83a9-ff3904bb5740 57955-0173 HUMAN OTC DRUG Climate Adaptation Hot and Humid Aloe socotrina, Bromium, Carboneum sulphuratum, Colchicum autumnale, Elaterium, Gelsemium sempervirens, Hamamelis virginiana, Hypothalamus, Iodium, Ipecacuanha, Natrum sulphuricum, Piper nigrum, Thyroidinum LIQUID ORAL 20131119 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; BROMINE; ACTIVATED CHARCOAL; CARBON DISULFIDE; COLCHICUM AUTUMNALE BULB; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; BOS TAURUS HYPOTHALAMUS; IODINE; IPECAC; SODIUM SULFATE; GREEN PEPPERCORN; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0176_268a19ec-1d63-4948-94ba-bb918c54f676 57955-0176 HUMAN OTC DRUG Childrens Fever Reliever Aceticum acidum, Aconitum napellus, Aesculus hippocastanum, Agaricus muscarius, Baptisia tinctoria, Belladonna, Bryonia alba, chamomilla, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Pulsatilla, Rhus toxicodendron, Sambucus nigra, Sulphur, Veratrum viride LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio INC. ACETIC ACID; ACONITUM NAPELLUS; HORSE CHESTNUT; AMANITA MUSCARIA FRUITING BODY; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; VERATRUM VIRIDE ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0211_e514eb9d-15e9-44f3-aa67-f47303b084c5 57955-0211 HUMAN OTC DRUG CS Bone Angustura vera, Asafoetida, Aurum metallicum, Calcarea Fluorica, Calcarea phosphorica, Hydrofluoricum acidum, Kali Iodatum, Mercurius vivus, Mezereum, Silicea, Symphytum officinale LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. ANGOSTURA BARK; ASAFETIDA; GOLD; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; HYDROFLUORIC ACID; POTASSIUM IODIDE; MERCURY; DAPHNE MEZEREUM BARK; SILICON DIOXIDE; COMFREY ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0212_5eb32b0d-8c37-4a08-9cee-43150bad2429 57955-0212 HUMAN PRESCRIPTION DRUG CS-Brain Arsenicum album, Arsenicum iodatum, Baryta carbonica, Calcarea carbonica, Carbo animalis, Kreosotum, Lachesis mutus, Phosphorus, Silicea LIQUID ORAL 20130301 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARBO ANIMALIS; WOOD CREOSOTE; LACHESIS MUTA VENOM; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0213_59c99c7e-d04d-4bf9-98c6-0fc4ec81f128 57955-0213 HUMAN OTC DRUG CS General Support Arsenicum album, Asterias rubens, Calendula officinalis, Cistus canadensis, Condurango, Conium maculatum, Gallicum acidum, Hoang-nan, Hydrastis canadensis, Kreosotum, Mercurius vivus, Radium bromatum, Thiosinaminum LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; ASTERIAS RUBENS; CALENDULA OFFICINALIS FLOWERING TOP; HELIANTHEMUM CANADENSE; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; GALLIC ACID MONOHYDRATE; STRYCHNOS WALLICHIANA BARK; GOLDENSEAL; WOOD CREOSOTE; MERCURY; RADIUM BROMIDE; ALLYLTHIOUREA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0214_7077ae29-85d8-4103-836e-ab58760f1b66 57955-0214 HUMAN OTC DRUG CS Breast Asterias rubens, Baryta iodata, Bellis perennis, Bromium, Carbo animalis, Clematis erecta, Conium maculatum, Graphites, Hydrastis canadensis, Phytolacca decandra, Plumbum lodatum, Sempervivum tectorum, Silicea LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. ASTERIAS RUBENS; BARIUM IODIDE; BELLIS PERENNIS; BROMINE; CARBO ANIMALIS; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; LEAD IODIDE; SEMPERVIVUM TECTORUM LEAF; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0215_a42a921d-41a6-4531-bea7-efeee11273cb 57955-0215 HUMAN OTC DRUG CS Lymph Hodgkins Aconitum lycoctonum, Arsenicum iodatum, Aurum muriaticum, Baryta iodata, Calcarea fluorica, Calcarea iodata, Carbo animalis, Cistus canadensis, Conium maculatum, Hoang-nan, Hydrastis canadensis, iodium, Kali muriaticum, Mercurius iodatus flavus, Mercurius iodatus ruber, Natrum muriaticum, Phosphorus, Phytolacca decandra, Plumbum iodatum, Scrophularia nodosa LIQUID ORAL 20160401 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM LYCOCTONUM; ARSENIC TRIIODIDE; GOLD TRICHLORIDE; BARIUM IODIDE; CALCIUM FLUORIDE; CALCIUM IODIDE; CARBO ANIMALIS; HELIANTHEMUM CANADENSE; CONIUM MACULATUM FLOWERING TOP; STRYCHNOS WALLICHIANA BARK; GOLDENSEAL; IODINE; POTASSIUM CHLORIDE; MERCUROUS IODIDE; MERCURIC IODIDE; SODIUM CHLORIDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; LEAD IODIDE; SCROPHULARIA NODOSA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0216_0150a554-f59d-43d6-8cae-594e7f81f376 57955-0216 HUMAN OTC DRUG CS-Ovary Apis mellifica, Arsenicum album, Aurum iodatum, Baryta muriatica, Colocynthis, Conium maculatum, Iodium, Lachesis mutus, Lycopodium clavatum, Naja tripudians, Oophorinum, Platinum metallicum, Podophyllum peltatum LIQUID ORAL 20140113 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; GOLD MONOIODIDE; BARIUM CHLORIDE DIHYDRATE; CITRULLUS COLOCYNTHIS FRUIT PULP; CONIUM MACULATUM FLOWERING TOP; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; NAJA NAJA VENOM; SUS SCROFA OVARY; PLATINUM; PODOPHYLLUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0217_4a2f6c17-c70d-4f17-91b5-3f78ccaf4e0f 57955-0217 HUMAN OTC DRUG CS Pain Reliever Apis mellifica, Arsenicum album, Calcarea acetica, Calcarea oxalica, Cedron, Conium maculatum, Echinacea purpurea, Euphorbium officinarum, Hydrastis canadensis, Ova tosta, Phosphoricum acidum, Silicea LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; CALCIUM ACETATE; CALCIUM OXALATE MONOHYDRATE; SIMABA CEDRON SEED; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; EGG SHELL, COOKED; PHOSPHORIC ACID; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0218_f2608e88-2806-46d8-9f1f-8b5be183c267 57955-0218 HUMAN OTC DRUG CS Rectal Bowel Alumina, Condurango, Hydrastis canadensis, Kali carbonicum, Nitricum acidum, Phytolacca decandra, Ruta graveolens, Sepia, Spigelia anthelmia LIQUID ORAL 20150829 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; MARSDENIA CONDURANGO BARK; GOLDENSEAL; POTASSIUM CARBONATE; NITRIC ACID; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SEPIA OFFICINALIS JUICE; SPIGELIA ANTHELMIA 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0220_23fd91de-d124-4199-bd29-af9fc9dbc213 57955-0220 HUMAN OTC DRUG CS Stomach Aceticum acidum, Arsenicum album, Cadmium sulphuricum, Condurango, Graphites, Hydrastis canadensis, Kali bichromicum, Magnesia phosphorica, Ornithogalum umbellatum LIQUID ORAL 20161209 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; ARSENIC TRIOXIDE; CADMIUM SULFATE; MARSDENIA CONDURANGO BARK; GRAPHITE; GOLDENSEAL; POTASSIUM DICHROMATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ORNITHOGALUM UMBELLATUM 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0221_90f27108-c6e3-490b-8840-aabb2b7fc762 57955-0221 HUMAN OTC DRUG CS Uterus Arsenicum iodatum, Aurum muriaticum, Bufo rana, Carbo animalis, Conium maculatum, Graphites, Hydrastis canadensis, Kreosotum, Lachesis mutus, Lapis albus, Murex purpurea, Phosphorus, Phytolacca decandra, Terebinthina LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIIODIDE; GOLD TRICHLORIDE; BUFO BUFO CUTANEOUS GLAND; CARBO ANIMALIS; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; GOLDENSEAL; WOOD CREOSOTE; LACHESIS MUTA VENOM; CALCIUM HEXAFLUOROSILICATE; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; TURPENTINE OIL 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0222_272939c4-553a-46f6-a460-2a7cdb0045b8 57955-0222 HUMAN OTC DRUG CS Brain Arsenicum album, Arsenicum iodatum, Baryta carbonica, Calcarea carbonica, Carbo animalis, Kreosotum, Lachesis mutus, Phosphorus, Silicea LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARBO ANIMALIS; WOOD CREOSOTE; LACHESIS MUTA VENOM; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0224_37e401ec-072c-4ed1-9d99-a963490ed5b1 57955-0224 HUMAN OTC DRUG CS Skin Aceticum acidum, Arsenicum album, Arsenicum iodatum, Condurango, Conium maculatum, Hydrastis canadensis, Kali arsenicosum, Kreosotum, Lycopodium clavatum, Phytolacca decandra, Silicea, Thuja occidentalis LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; POTASSIUM ARSENITE ANHYDROUS; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0226_4ad970c5-dc4f-4c30-9732-4e605b1d5e63 57955-0226 HUMAN OTC DRUG CS Lung Acalypha indica, Aranea diadema, Arsenicum iodatum, Bromium, Bryonia, Chelidonium majus, Conium maculatum, Euphorbium officinarum, Methylene blue, Phosphorus, Sulphuricum acidum LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. ACALYPHA INDICA; ARANEUS DIADEMATUS; ARSENIC TRIIODIDE; BROMINE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; EUPHORBIA RESINIFERA RESIN; METHYLENE BLUE; PHOSPHORUS; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0242_f27c12c4-9752-4ff8-8cbc-a717f29ea02a 57955-0242 HUMAN OTC DRUG Hydration Aloe socotrine, Apis mellifica, Avena sativa, Carbo vegetabilis, Equisetum hyemale, Gelsemium sempervirens, Pulsatilla, Selenium metallicum, Taraxacum officinale LIQUID ORAL 20140227 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; APIS MELLIFERA; AVENA SATIVA FLOWERING TOP; ACTIVATED CHARCOAL; EQUISETUM HYEMALE; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS; SELENIUM; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0272_1caaf1b7-9339-491f-a7ae-6f0e78d664f6 57955-0272 HUMAN OTC DRUG Fever Reliever Aceticum ac, Aconitum nap, Aesculus hipp, Agaricus musc, Baptisia, Belladonna, Bryonia, Chamomilla, Eupatorium perf, Ferrum phos, Gelsemium, Pulsatilla, Rhus tox, Sambucus nig, Sulphur, Veratrum LIQUID ORAL 20180206 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; ACONITUM NAPELLUS; HORSE CHESTNUT; AMANITA MUSCARIA FRUITING BODY; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA CHAMOMILLA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; VERATRUM VIRIDE ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20191231 57955-0275_6e7194e0-cc4c-45b5-b131-32aca334fc1f 57955-0275 HUMAN OTC DRUG Tinnitus Relief arnica montana, calcarea carbonica, chenopodium anthelminticum, chininum salicylicum, cimicifuga racemosa, coffea tosta, kali iodatum, kalmia latifolia, magnesia carbonica, manganum aceticum, manganum carbonicum, mercurius vivus, natrum salicylicum, salicylicum acidum, thiosinaminum, thyroidinum LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; QUININE SALICYLATE; BLACK COHOSH; COFFEA ARABICA SEED, ROASTED; POTASSIUM IODIDE; KALMIA LATIFOLIA LEAF; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; MANGANESE CARBONATE; MERCURY; SODIUM SALICYLATE; SALICYLIC ACID; ALLYLTHIOUREA; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0277_9eb6aa99-46eb-4e4b-8a4c-3b47571b2e91 57955-0277 HUMAN OTC DRUG M3 Metabolic Mineral Modulator Aqua marina, Calcarea carbonica, Calcarea fluorica, Guaiacum, Hekla lava, Lecithin, Parathormonum, Pyridoxinum hydrochloricum LIQUID ORAL 20130927 UNAPPROVED HOMEOPATHIC King Bio Inc. SODIUM CHLORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; GUAIAC; HEKLA LAVA; EGG PHOSPHOLIPIDS; PARATHYROID HORMONE; PYRIDOXINE HYDROCHLORIDE 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0278_c1bf25eb-1d8e-44ca-8498-2afea565f618 57955-0278 HUMAN OTC DRUG Water Retention Aceticum acidum, Apis mellifica, Apocynum cannabinum, Berberis vulgaris, Cahinca, Digitalis purpurea, Helleborus niger, Hydrocotyle asiatica, Natrum muriaticum, Oxydendrum arboreum, Plumbum metallicum, Sambucus nigra, Solidago virgaurea, Strophanthus hispidus LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio INC. ACETIC ACID; APIS MELLIFERA; APOCYNUM CANNABINUM ROOT; BERBERIS VULGARIS ROOT BARK; CHIOCOCCA ALBA ROOT; DIGITALIS; HELLEBORUS NIGER ROOT; CENTELLA ASIATICA; SODIUM CHLORIDE; OXYDENDRUM ARBOREUM LEAF; LEAD; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0281_d53da238-01a9-4feb-9d27-959923aa4abf 57955-0281 HUMAN OTC DRUG Heavy Metal Detox Alumina, Arsenicum album, Arsenicum lodatum, Berberis vulgaris, Cadmium sulphuratum, Chelidonium majus, Chromium oxydatum, Cuprum metallicum, Cysteinum, Glycerinum, Glycyrrhiza glabra, Kali muriaticum, Magnesia sulphurica, Mercurius corrosivus, Mercurius cyanatus, Mercurius dulcis, Mezereum, Natrum muriaticum, Niccolum metallicum, Oleum morrhuae, Phytolacca decandra, Plumbum iodatum, plumbum metallicum, Selenium metallicum, solidago virgaurea, Stannum metallicum LIQUID ORAL 20150821 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; BERBERIS VULGARIS ROOT BARK; CADMIUM SULFIDE; CHELIDONIUM MAJUS; CHROMIC OXIDE; COPPER; CYSTEINE; GLYCERIN; GLYCYRRHIZA GLABRA; POTASSIUM CHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; MERCURIC CHLORIDE; MERCURIC CYANIDE; CALOMEL; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; NICKEL; COD LIVER OIL; PHYTOLACCA AMERICANA ROOT; LEAD IODIDE; LEAD; SELENIUM; SOLIDAGO VIRGAUREA FLOWERING TOP; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0285_a1db02cd-8eae-40c2-b958-ea93dc4f13a9 57955-0285 HUMAN OTC DRUG Environmental Adaptation Hot and Humid aloe socotrina, bromium, carbo vegetabilis, carboneum sulphuratum, colchicum autumnale, elaterium, gelsemium sempervirens, hamamelis virginiana, hypothalamus, iodum, ipecacuanha, natrum sulphuricum, piper nigrum, thyroidinum LIQUID ORAL 20161122 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; BROMINE; ACTIVATED CHARCOAL; CARBON DISULFIDE; COLCHICUM AUTUMNALE BULB; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; BOS TAURUS HYPOTHALAMUS; IODINE; IPECAC; SODIUM SULFATE; GREEN PEPPERCORN; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0287_a9050cd9-5c08-4a79-b18d-0d461db36237 57955-0287 HUMAN OTC DRUG Environmental Adaptation Weather Changes Alumen, Benzoicum acidum, Cadmium sulphuricum, Chelidonium majus, Colchicum autumnale, Dulcamara, Hypothalamus, Manganum aceticum, Mercurius solubilis, Natrum muriaticum, Nitricum acidum, Phosphorus, Ranunculus bulbosus, Rhododendron chrysanthum, Thyroidinum LIQUID ORAL 20150818 UNAPPROVED HOMEOPATHIC King Bio Inc. POTASSIUM ALUM; BENZOIC ACID; CADMIUM SULFATE; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; BOS TAURUS HYPOTHALAMUS; MANGANESE ACETATE TETRAHYDRATE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORUS; RANUNCULUS BULBOSUS; RHODODENDRON AUREUM LEAF; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0288_250577e6-1a73-4e1c-997c-b4e7f76a2a20 57955-0288 HUMAN OTC DRUG Environmental Adaptation Cold and Dry Aconitum napellus, Agaricus muscarius, Asarum europaeum, Aurum metallicum, Bryonia, Camphora, Causticum, Hepar sulphuris calcareum, Hypothalamus, Kali carbonicum, Petroleum, Secale cornutum, Sepia, Thyroidinum LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; ASARUM EUROPAEUM; GOLD; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CAUSTICUM; CALCIUM SULFIDE; BOS TAURUS HYPOTHALAMUS; POTASSIUM CARBONATE; KEROSENE; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0298_28ed1cf1-0dc4-4ceb-9aee-fa9bb6cb47e1 57955-0298 HUMAN OTC DRUG Influenza Multi-Strain Flu Medicine Anas barbariae, Arsenicum alb, Baptisia, Bryonia, Causticum, Cinchona, Dulcamara, Echinacea purp, Eucalyptus, Eupatorium perf, Gelsemium, Influenzinum, Lachesis, Phytolacca, Rhus tox, Sarcolacticum ac, Sulphur, Wyethia, Zinc acet, Zinc mur, Zinc oxyd. LIQUID ORAL 20180122 UNAPPROVED HOMEOPATHIC King Bio Inc. CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; WYETHIA HELENIOIDES ROOT; ZINC ACETATE ANHYDROUS; ZINC OXIDE; ZINC CHLORIDE 35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20191231 57955-0300_79a9b5c3-149d-4619-aa89-ccb4d9161e39 57955-0300 HUMAN OTC DRUG CA Miasm Aconitum napellus, Arsenicum album, Cadmium sulphuricum, Conium maculatum, Gelsemium sempervirens, Hydrastis canadensis, Phytolacca decandra LIQUID ORAL 20160422 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; CADMIUM SULFATE; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0305_ca44f63d-749f-4062-8fc7-ac3158825310 57955-0305 HUMAN OTC DRUG SYC Miasm Aconitum napellus, Cantharis, Gelsemium sempervirens, Natrum sulphuricum, Picricum acidum, Pulsatilla, Sepia, Staphysagria LIQUID ORAL 20140120 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; LYTTA VESICATORIA; GELSEMIUM SEMPERVIRENS ROOT; SODIUM SULFATE; PICRIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0306_ba232533-a553-466b-a949-f9eedcacc44e 57955-0306 HUMAN OTC DRUG SYP Miasm Arsenicum album, Aurum metallicum, Baryta carbonica, Hydrofluoricum acidum, Kali iodatum, Lachesis mutus, Mercurius vivus, Nitricum acidum, Nux vomica, Phytolacca decandra LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; HYDROFLUORIC ACID; POTASSIUM IODIDE; LACHESIS MUTA VENOM; MERCURY; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0318_551eea25-8f38-4ebb-b9e4-86bf6cbefcdb 57955-0318 HUMAN OTC DRUG Childrens Appetite Enhancer Alumina, Antimonium crudum, Arsenicum Album, Asarum europaeum, Baptisia tinctoria, Carbolicum acidum, Chininum arsenicosum, Cocculus indicus, Lecithin, Picricum acidum, Pulsatilla, Rhus toxicodendron, Silicea, Sulphur LIQUID ORAL 20150831 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; BAPTISIA TINCTORIA ROOT; PHENOL; QUININE ARSENITE; ANAMIRTA COCCULUS SEED; EGG PHOSPHOLIPIDS; PICRIC ACID; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0319_184a78ba-7c69-440a-82bd-ed0d4c006970 57955-0319 HUMAN OTC DRUG Foul Bowel Ammonium carbonicum, Asafoetida, Baptisia tinctoria, Carbo vegetabilis, Carbolicum acidum, Graphites, Kreosotum, Mercurius corrosivus, Oleander, Phosphorus, Rhus toxicodendron, Zincum metallicum LIQUID ORAL 20160627 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CARBONATE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; ACTIVATED CHARCOAL; PHENOL; GRAPHITE; WOOD CREOSOTE; MERCURIC CHLORIDE; NERIUM OLEANDER LEAF; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 57955-0321_bfea8445-cae3-46be-84c9-8b58456e9bad 57955-0321 HUMAN OTC DRUG Upper GI Restoration Aceticum acidum, Agaricus muscarius, Aloe socotrina, Antimonium crudum, Argentum nitricum, Carbo vegetabilis, Carduus marianus, Chelidonium majus, Chenopodium anthelminticum, Cinchona officinalis, Graphites, Ipecacuanha, Lac defloratum, Mentha piperita, Nux vomica, Secale cornutum, Tanacetum vulgare, Teucrium marum, Zingiber officinale LIQUID ORAL 20131022 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; AMANITA MUSCARIA FRUITING BODY; ALOE; ANTIMONY TRISULFIDE; SILVER NITRATE; ACTIVATED CHARCOAL; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; DYSPHANIA AMBROSIOIDES; CINCHONA OFFICINALIS BARK; GRAPHITE; IPECAC; SKIM MILK; MENTHA PIPERITA; STRYCHNOS NUX-VOMICA SEED; CLAVICEPS PURPUREA SCLEROTIUM; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0322_e14b82eb-e686-4fb7-8002-bf1268920aec 57955-0322 HUMAN OTC DRUG Lower GI Restoration Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltaum, Sepia, Silicea LIQUID ORAL 20160408 UNAPPROVED HOMEOPATHIC King Bio Inc. AETHUSA CYNAPIUM; GARLIC; BAPTISIA TINCTORIA ROOT; CAPSICUM; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; MARSDENIA CONDURANGO BARK; GAMBOGE; GRATIOLA OFFICINALIS; COW MILK; LACTIC ACID, DL-; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0325_9a18cf94-6f69-47ee-83cd-2fe0934279e9 57955-0325 HUMAN OTC DRUG Upper GI Restoration Aceticum ac, Agaricus musc, Aloe, Antimonium crud, Arg nit, Carbo veg, Carduus mar, Chelidonium maj, Chenopodium anth, Cinchona, Graphites, Ipecac, Lac deflor, Mentha pip, Nux vom, Secale, Tanacetum, Teucrium mar, Zingiber. LIQUID ORAL 20180131 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; AMANITA MUSCARIA FRUITING BODY; ALOE; ANTIMONY TRISULFIDE; SILVER NITRATE; ACTIVATED CHARCOAL; MILK THISTLE; CHELIDONIUM MAJUS; DYSPHANIA AMBROSIOIDES; CINCHONA OFFICINALIS BARK; GRAPHITE; IPECAC; SKIM MILK; MENTHA PIPERITA; STRYCHNOS NUX-VOMICA SEED; CLAVICEPS PURPUREA SCLEROTIUM; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20191231 57955-0361_fd4bf188-fbf8-4aea-8b48-5ee41a71b6be 57955-0361 HUMAN OTC DRUG Total Body Detox Alumina, Bryonia alba, Calcarea iodata, Cantharis, Carduus benedictus, Carduus marianus, Chelidonium majus, Cinchona officinalis, Cynara scolymus, Dioscorea villosa, Hepar sulphuris calcareum, Iris versicolor, Juniperus communis, Kali iodatum, Mercurius corrosivus, Mercurius vivus, Natrum carbonicum, Nux vomica, Plumbum metallicum, Ptelea trifoliata, Ricinus communis, Robinia pseudoacacia, Serum anguillae, Solidago virgaurea, Sulphur, Sulphuricum acidum, Taraxacum officinale LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; BRYONIA ALBA ROOT; CALCIUM IODIDE; LYTTA VESICATORIA; CENTAUREA BENEDICTA; MILK THISTLE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA TUBER; CALCIUM SULFIDE; IRIS VERSICOLOR ROOT; JUNIPER BERRY; POTASSIUM IODIDE; MERCURIC CHLORIDE; MERCURY; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; LEAD; PTELEA TRIFOLIATA BARK; RICINUS COMMUNIS SEED; ROBINIA PSEUDOACACIA BARK; ANGUILLA ROSTRATA BLOOD SERUM; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; SULFURIC ACID; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0382_0cf7489f-4945-482a-b07a-dcbd09a366c8 57955-0382 HUMAN OTC DRUG Colds and Flu Anas barbariae, Arsenicum album, Baptisia tinctoria, Bryonia, Dulcamara, Echinacea, Echinacea purpurea, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Influenzinum, Kali muriaticum, Phosphorus, Pulsatilla, Sulphur, Zincum aceticum, Zincum carbonicum, Zincum metallicum, Zincum muriaticum, Zincum oxydatum, Zincum picricum, Zincum valerianicum LIQUID ORAL 20121022 UNAPPROVED HOMEOPATHIC King Bio Inc. CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; SOLANUM DULCAMARA TOP; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; POTASSIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; ZINC ACETATE ANHYDROUS; ZINC CARBONATE; ZINC; ZINC CHLORIDE; ZINC OXIDE; ZINC PICRATE NONAHYDRATE; ZINC VALERATE DIHYDRATE 50; 10; 10; 10; 10; 10; 10; 10; 10; 10; 50; 50; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0420_22b9f571-1f43-40b9-b809-0a0391b3b86a 57955-0420 HUMAN OTC DRUG EMF Detox Adrenalinum, Argentum iodatum, Cadmium sulphuricum, Capsicum Annuum, Fucus vesiculosus, Iodium, Kali iodatum, Ledum palustre, Lycopodium clavatum, Phosphoricum acidum, Phosphorus, Pulsatilla, Radium bromatum Strontium carbonicum, Thyroidinum, Uranium nitricum, X-ray LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; SILVER IODIDE; CADMIUM SULFATE; CAPSICUM; FUCUS VESICULOSUS; IODINE; POTASSIUM IODIDE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; RADIUM BROMIDE; STRONTIUM CARBONATE; THYROID, UNSPECIFIED; URANYL NITRATE HEXAHYDRATE; ALCOHOL, X-RAY EXPOSED (1000 RAD) 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0423_920c7e55-d036-4558-bcd3-0194569146d0 57955-0423 HUMAN OTC DRUG Kids Stress and Anxiety Aconitum napellus, Aethusa cynapium, Alfalfa, Aurum metallicum, Avena sativa, Baryta carbonica, Chamomilla, Ignatia amara, Impatiens glandulifera, flos, Kali phosphoricum, Laurocerasus, Natrum phosphoricum, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Staphysagria, Stramonium LIQUID ORAL 20160901 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AETHUSA CYNAPIUM; ALFALFA; GOLD; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; MATRICARIA RECUTITA; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; POTASSIUM PHOSPHATE, DIBASIC; PRUNUS LAUROCERASUS LEAF; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0435_8e1dcc9e-2960-4c82-9100-95e7a8b9a352 57955-0435 HUMAN OTC DRUG Leg Cramps and Spasms Calcarea carbonica, Cuprum metallicum, Gnaphalium polycephalum, Hyoscyamus niger, Ignatia amara, Magnesia phosphorica, Nux vomica, Passiflora incarnata, Platinum metallicum, Plumbum metallicum, Secale cornutum, Strychninum, LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; COPPER; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PLATINUM; LEAD; CLAVICEPS PURPUREA SCLEROTIUM; STRYCHNINE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0722_c207cf06-7c37-4e75-b3f1-000966f1173f 57955-0722 HUMAN OTC DRUG Dairy Intolerances Aethusa cynapium, Anacardium orientale, Apium graveolens, Calcarea carbonica, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lac defloratum, Lac vaccinum, Pulsatilla, Sepia, Sulphur LIQUID ORAL 20131125 UNAPPROVED HOMEOPATHIC King Bio Inc. AETHUSA CYNAPIUM; SEMECARPUS ANACARDIUM JUICE; CELERY SEED; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; SKIM MILK; COW MILK; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0723_007fc434-6d87-4168-9d32-5e33a1c5f853 57955-0723 HUMAN OTC DRUG Eggs and Meats Intolerances Calcarea carbonica, Causticum, Chloramphenicolum, Colchicum autumnale, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Ichthyolum, Lecithin, Ova tosta, Ovi gallinae pellicula, Pulsatilla, Pyrogenium LIQUID ORAL 20131119 UNAPPROVED HOMEOPATHIC King Bio Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; CHLORAMPHENICOL; COLCHICUM AUTUMNALE BULB; GAMBOGE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; ICHTHAMMOL; EGG PHOSPHOLIPIDS; EGG SHELL, COOKED; EGG SHELL MEMBRANE; PULSATILLA VULGARIS; RANCID BEEF 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0724_d8986a56-8c38-45c4-bc56-cb699259d390 57955-0724 HUMAN OTC DRUG Grains and Gluten Intolerances Arsenicum album, Bryonia, Histaminum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum muriaticum, Pulsatilla, Sabadilla, Secale cornutum, Sulphur LIQUID ORAL 20131119 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; CLAVICEPS PURPUREA SCLEROTIUM; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0727_b095088b-fcab-4de8-861b-2284abb23c04 57955-0727 HUMAN OTC DRUG Food Intolerances Aethusa cynapium, Calcarea carbonica, Cucurbita pepo, semen, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum carbonicum, Nitricum acidum, Nux vomica, Ovi gallinae pellicula, Phosphorus, Pulsatilla, Sulphur LIQUID ORAL 20140623 UNAPPROVED HOMEOPATHIC King Bio Inc. AETHUSA CYNAPIUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PUMPKIN SEED; GAMBOGE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; EGG SHELL MEMBRANE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0758_9f07d14a-6dd5-47e3-bf7c-16eb81099bf7 57955-0758 HUMAN OTC DRUG Childrens Ear Relief Aconitum napellus, Allium cepa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, Silicea LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ONION; APIS MELLIFERA; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CAUSTICUM; MATRICARIA RECUTITA; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM CHLORIDE; CALOMEL; MERCURIUS SOLUBILIS; PLANTAGO MAJOR; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0815_fb6d516d-b6b5-47da-9e10-153f96a0bb39 57955-0815 HUMAN OTC DRUG Mole Remover Carbo vegetabilis, Graphites, Lycopodium clavatum, Phytolacca decandra, Thuja occidentalis LIQUID TOPICAL 20140813 UNAPPROVED HOMEOPATHIC King Bio Inc. CARBO ANIMALIS; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL N 20191231 57955-0816_07263009-fc02-4c19-ae9a-a030ce40d201 57955-0816 HUMAN OTC DRUG Scar Remover Arnica montana, Calcarea fluorica, Calcarea phosphorica, Calendula officinalis, Graphites, Hydrofluoricum acidum, Phytolacca decandra, Sabina, Silicea, Thiosinaminum, Thuja occidentalis LIQUID TOPICAL 20140318 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; HYDROFLUORIC ACID; PHYTOLACCA AMERICANA ROOT; JUNIPERUS SABINA LEAFY TWIG; SILICON DIOXIDE; ALLYLTHIOUREA; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL N 20181231 57955-0817_bb821bc6-eb47-4d9e-a2a1-c24eb82b185e 57955-0817 HUMAN OTC DRUG Cherry Angioma Remover Benzoicum acidum, Calcarea carbonica, Calcarea iodata, Iodium, Phosphoricum acidum, Phosphorus, Sulphuricum acidum LIQUID TOPICAL 20140805 UNAPPROVED HOMEOPATHIC King Bio Inc. BENZOIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM IODIDE; IODINE; PHOSPHORIC ACID; PHOSPHORUS; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL N 20181231 57955-0818_7435d010-f2b1-4ae6-86c4-ef135dc08815 57955-0818 HUMAN OTC DRUG Wart Remover Antimonium crudum, Causticum, Dulcamara, Kali muriaticum, Nitricum acidum, Sabina, Staphysagria, Sulfur, Thuja occidentalis LIQUID TOPICAL 20140318 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; CAUSTICUM; SOLANUM DULCAMARA TOP; POTASSIUM CHLORIDE; NITRIC ACID; JUNIPERUS SABINA LEAFY TWIG; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL N 20181231 57955-0919_f566190d-1c29-406e-8c3e-9a3d6cb632e8 57955-0919 HUMAN OTC DRUG Rosacea Symptom Relief Calendula officinalis, Cardiospermum, Chamomilla, Hydrocotyle asiatica, Rhus tox, Thuja occidentalis CREAM TOPICAL 20170301 UNAPPROVED HOMEOPATHIC King Bio Inc. CALENDULA OFFICINALIS FLOWERING TOP; CARDIOSPERMUM HALICACABUM FLOWERING TOP; MATRICARIA RECUTITA; CENTELLA ASIATICA; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG 10; 2; 10; 10; 10; 3 [hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g; [hp_X]/83g N 20181231 57955-0920_56fe6b3f-b054-4c84-9d18-b28d361e1cd4 57955-0920 HUMAN OTC DRUG Psoriasis Symptom Relief Cardiospermum, Chamomilla, Glycyrrhiza glabra, Hydrocotyle asiatica, Lappa major, Phytolacca decandra, Rumex crispus, Ruta graveolens, Taraxacum officinale CREAM TOPICAL 20170301 UNAPPROVED HOMEOPATHIC King Bio Inc. CARDIOSPERMUM HALICACABUM FLOWERING TOP; MATRICARIA RECUTITA; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; RUMEX CRISPUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; TARAXACUM OFFICINALE 2; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g N 20181231 57955-0921_3e5170a1-9305-49f0-ab77-db3e2a9bbe69 57955-0921 HUMAN OTC DRUG Eczema Symptom Relief Cardiospermum, Hydrastis canadensis, Hydrocotyle asiatica, Lappa major, Rhus tox, Rumex crispus, Ruta graveolens, Sanguinaria canadensis, Taraxacum officinale CREAM TOPICAL 20170301 UNAPPROVED HOMEOPATHIC King Bio Inc. CARDIOSPERMUM HALICACABUM FLOWERING TOP; GOLDENSEAL; CENTELLA ASIATICA; ARCTIUM LAPPA ROOT; TOXICODENDRON PUBESCENS LEAF; RUMEX CRISPUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; TARAXACUM OFFICINALE 2; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g N 20181231 57955-0980_aa4d22dc-f403-43de-9c16-0c423a80a64b 57955-0980 HUMAN OTC DRUG Burnout Alfalfa, Ambra grisea, Anacardium orientale, Argentum nitricum, Aurum metallicum, Avena sativa, Caladium seguinum, Calcarea carbonica, Cocculus indicus, Gelsemium sempervirens, Ignatia amara, Kali phosphoricum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Phosphoricum acidum, Phosphorus, Selenium metallicum, Sepia, Silicea, Sulphur LIQUID ORAL 20131009 UNAPPROVED HOMEOPATHIC King Bio Inc. ALFALFA; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-0981_cafd5689-28b7-450d-8d8a-a463a08429e4 57955-0981 HUMAN OTC DRUG Adrenal Burnout Adrenalinum, Aesculus hippocastanum, flos, Alfalfa, Ambra grisea, Anacardium orientale, argentum nitricum, Avena sativa, Calcarea carbonica, Carboneum oxygenisatum, carpinus betulus, flos, Citricum acidum, Gelsemium sempervirens, Hypothalamus, Kali phosphoricum, Lecithin, Natrum muriaticum, Olea europaea, flos, Phosphoricum acidum, Pituitarum posterium, Selenium metallicum, Sepia, Silicea, Thyroidinum LIQUID ORAL 20141210 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; AESCULUS HIPPOCASTANUM FLOWER; ALFALFA; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; AVENA SATIVA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARBON MONOXIDE; CARPINUS BETULUS FLOWERING TOP; ANHYDROUS CITRIC ACID; GELSEMIUM SEMPERVIRENS ROOT; BOS TAURUS HYPOTHALAMUS; POTASSIUM PHOSPHATE, DIBASIC; EGG PHOSPHOLIPIDS; SODIUM CHLORIDE; OLEA EUROPAEA FLOWER; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1010_2855bf30-2738-4a3c-9d40-396513a7d3e2 57955-1010 HUMAN PRESCRIPTION DRUG Physical Anger Allium sativum, Belladonna, Calendula officinalis, Cantharis, Cichorium intybus, flos, Cimex Lectularius, Fagus sylvatica, flos, Gallicum acidum, Hepar sulphuris calcareum, Ilex aquifolium, flos, Impatiens glandulifera, flos, Iodium, Moschus, Salix vitellina, flos, Tarentula hispana, Terebinthina, Veratrum album LIQUID ORAL 20130312 UNAPPROVED HOMEOPATHIC King Bio Inc. GARLIC; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; LYTTA VESICATORIA; CICHORIUM INTYBUS FLOWER; CIMEX LECTULARIUS; FAGUS SYLVATICA FLOWERING TOP; GALLIC ACID MONOHYDRATE; CALCIUM SULFIDE; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; IODINE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; SALIX ALBA FLOWERING TOP; LYCOSA TARANTULA; TURPENTINE OIL; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 57955-1011_8b06d5bb-e674-4cdc-b090-2a29dc3ca5a2 57955-1011 HUMAN OTC DRUG Physical Anger Allium sativum, Belladonna, Calendula officinalis, Cantharis, Cichorium intybus, flos, Cimex lectularius, Fagus sylvatica, flos, Gallicum acidum, Hepar sulphuris calcareum, Ilex aquifolium, flos, Impatiens glandulifera, flos, Iodium, Moschus, Salix vitellina, flos LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. GARLIC; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; LYTTA VESICATORIA; CICHORIUM INTYBUS FLOWER; CIMEX LECTULARIUS; FAGUS SYLVATICA FLOWERING TOP; GALLIC ACID MONOHYDRATE; CALCIUM SULFIDE; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; IODINE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; SALIX ALBA FLOWERING TOP 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1020_354f8622-ccd2-4079-9c0f-b8321973b970 57955-1020 HUMAN OTC DRUG Easily Angered Aesculus carnea, flos, Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Antimonium crudum, Avena sativa, Chamomilla, Colocynthis, Crocus sativus, Ferrum metallicum, Impatiens glandulifera, flos, Kali carbonicum, Natrum muriaticum, Populus tremula, flos, Staphysagria, Thyroidinum LIQUID ORAL 20140113 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS CARNEA FLOWER; AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; ANTIMONY TRISULFIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; SAFFRON; IRON; IMPATIENS GLANDULIFERA FLOWER; POTASSIUM CARBONATE; SODIUM CHLORIDE; POPULUS TREMULA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1021_bbaa768f-c3a8-4770-a1a7-9102f236249b 57955-1021 HUMAN OTC DRUG Easily Angered Aesculus carnea, flos, Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Antimonium crudum, Avena sativa, Chamomilla, Colocynthis, Crocus sativus, Ferrum metallicum, Impatiens glandulifera, flos, Kali carbonicum, Natrum muriaticum, Populus tremula, flos, Staphysagria, Thyroidinum LIQUID ORAL 20140402 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS CARNEA FLOWER; AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; ANTIMONY TRISULFIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; SAFFRON; IRON; IMPATIENS GLANDULIFERA FLOWER; POTASSIUM CARBONATE; SODIUM CHLORIDE; POPULUS TREMULA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1031_d8ca5b99-1b44-4f19-9e15-39444fad046c 57955-1031 HUMAN OTC DRUG Stubborn and Contentious Abrotanum, Allium sativum, Antimonium tartaricum, Aurum metallicum, Bromium, Calendula officinalis, Capsicum annuum, Chamomilla, Cichorium intybus, flos, Fagus sylvatica, flos, Ilex aquifolium, flos, Impatiens glandulifera, flos, Juglans regia, flos, Kali carbonicum Lilium tigrinum, Lycopodium clavatum, Moschus, Nux vomica, Salix vitellina, flos, Salvia officinalis LIQUID ORAL 20150922 UNAPPROVED HOMEOPATHIC King Bio Inc. ARTEMISIA ABROTANUM FLOWERING TOP; GARLIC; ANTIMONY POTASSIUM TARTRATE; GOLD; BROMINE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; MATRICARIA RECUTITA; CICHORIUM INTYBUS FLOWER; FAGUS SYLVATICA FLOWERING TOP; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; JUGLANS REGIA FLOWERING TOP; POTASSIUM CARBONATE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; STRYCHNOS NUX-VOMICA SEED; SALIX ALBA FLOWERING TOP; SAGE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1041_4efe5c62-cb03-480c-aee1-48c6b61c57e1 57955-1041 HUMAN OTC DRUG Vindictive Absinthium, Aloe socotrina, Arnica montana, Colocynthis, Fagus sylvatica, flos, Hepar sulphuris calcareum, Ilex aquifolium, flos, Ipecacuanha, Malus pumila, flos, Nitricum acidum, Nux vomica, Pinus sylvestris, flos, Platinum metallicum, Salix vitellina, flos, Strychninum, Thea sinensis, Verbascum thapsus LIQUID ORAL 20131217 UNAPPROVED HOMEOPATHIC King Bio Inc. WORMWOOD; ALOE; ARNICA MONTANA; CITRULLUS COLOCYNTHIS FRUIT PULP; FAGUS SYLVATICA FLOWERING TOP; CALCIUM SULFIDE; ILEX AQUIFOLIUM FLOWERING TOP; IPECAC; MALUS DOMESTICA FLOWER; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PINUS SYLVESTRIS FLOWERING TOP; PLATINUM; SALIX ALBA FLOWERING TOP; STRYCHNINE; GREEN TEA LEAF; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1070_41ef5ea4-58b8-48ed-8c32-f48f19f5c063 57955-1070 HUMAN OTC DRUG Self Abuse Agaricus muscarius, Aloe socotrina, Aurum metallicum, Carboneum sulphuratum, Chamomilla, Cimicifuga racemosa, Ilex aquifolium, flos, Lilium tigrinum, Malus pumila, flos, Millefolium, Natrum carbonicum, Pinus sylvestris, flos, Stramonium, Tarentula hispana LIQUID ORAL 20130807 UNAPPROVED HOMEOPATHIC King Bio Inc. AMANITA MUSCARIA FRUITING BODY; ALOE; GOLD; CARBON DISULFIDE; MATRICARIA RECUTITA; BLACK COHOSH; ILEX AQUIFOLIUM FLOWERING TOP; LILIUM LANCIFOLIUM WHOLE FLOWERING; MALUS DOMESTICA FLOWER; ACHILLEA MILLEFOLIUM; SODIUM CARBONATE; PINUS SYLVESTRIS FLOWERING TOP; DATURA STRAMONIUM; LYCOSA TARANTULA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1071_d9987a96-8ae7-4852-b1c4-fcac32a8a7a8 57955-1071 HUMAN OTC DRUG Self-Abuse Agaricus muscarius, Aloe, Aurum metallicum, Carboneum sulphuratum, Chamomilla, Cimicifuga racemosa, Ilex aquifolium, flos, Lilium tigrinum, Malus pumila, flos, Millefolium, Natrum carbonicum, Pinus sylvestris, flos, Stramonium, Tarentula hispanica LIQUID ORAL 20161115 UNAPPROVED HOMEOPATHIC King Bio Inc. AMANITA MUSCARIA FRUITING BODY; ALOE; GOLD; CARBON DISULFIDE; MATRICARIA RECUTITA; BLACK COHOSH; ILEX AQUIFOLIUM FLOWERING TOP; LILIUM LANCIFOLIUM WHOLE FLOWERING; MALUS DOMESTICA FLOWER; ACHILLEA MILLEFOLIUM; SODIUM CARBONATE; PINUS SYLVESTRIS FLOWERING TOP; DATURA STRAMONIUM; LYCOSA TARANTULA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1081_88b08531-1206-4761-af02-0799986fcede 57955-1081 HUMAN OTC DRUG Criticize and Contradict Benzinum, Capsicum annuum, Chamomilla, Guaiacum, Helonias dioica, Juglans regia, flos, Lachesis mutus, Mezereum, Nux vomica, Platinum metallicum, Salix vitellina, flos, Salvia officinalis, Senega officinalis, Sepia, Sulphur, Veratrum album LIQUID ORAL 20121018 UNAPPROVED HOMEOPATHIC King Bio Inc. BENZENE; CAPSICUM; MATRICARIA RECUTITA; GUAIACUM OFFICINALE RESIN; CHAMAELIRIUM LUTEUM ROOT; JUGLANS REGIA FLOWERING TOP; LACHESIS MUTA VENOM; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PLATINUM; SALIX ALBA FLOWERING TOP; SAGE; POLYGALA SENEGA ROOT; SEPIA OFFICINALIS JUICE; SULFUR; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1257_2aebb1f7-8d9a-4c4c-a192-9c861b055acb 57955-1257 HUMAN OTC DRUG Expressed Sexual Issues Arnica montana, Avena sativa, Cantharis, Chamomilla, Helianthus annuus, Hyoscyamus niger, Malus pumila, flos, mimulus guttatus, flos, moschus, murex purpurea, ocimum basilicum, ornithogalum umbellatum, flos, Phytolacca decandra, Platinum metallicum, Salix nigra, Stramonium, Tarentula hispana LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; LYTTA VESICATORIA; MATRICARIA RECUTITA; HELIANTHUS ANNUUS FLOWERING TOP; HYOSCYAMUS NIGER; MALUS DOMESTICA FLOWER; MIMULUS GUTTATUS FLOWERING TOP; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; BASIL; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; PLATINUM; SALIX NIGRA BARK; DATURA STRAMONIUM; LYCOSA TARANTULA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1260_2dd8b990-01be-40b1-8fff-f484fd17295a 57955-1260 HUMAN PRESCRIPTION DRUG Repressed Sexual Issues Agnus castus, Arundo mauritanica, Avena sativa, Conium maculatum, Gelsemium sempervirens, Ilex aquifolium, flos, Moschus, Origanum majorana, Pinus sylvestris, flos, Selenium metallicum, Sepia, Staphysagria LIQUID ORAL 20120312 UNAPPROVED HOMEOPATHIC King Bio Inc. CHASTE TREE; ARUNDO PLINIANA ROOT; AVENA SATIVA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ILEX AQUIFOLIUM FLOWERING TOP; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; ORIGANUM MAJORANA WHOLE; PINUS SYLVESTRIS FLOWERING TOP; SELENIUM; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1270_991305ec-bd96-44e6-805f-4a0cec54ff21 57955-1270 HUMAN PRESCRIPTION DRUG Sexual Identity Ammonioum muriaticum, Conium maculatum, Ignatia amara, Juglans regia, flos, Mancinella, Natrum muriaticum, Ocimum basilicum, Phosphorus, Platinum metallicum, Sepia, Staphysagria, Thuja occidentalis LIQUID ORAL 20130312 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CHLORIDE; CONIUM MACULATUM FLOWERING TOP; STRYCHNOS IGNATII SEED; JUGLANS REGIA FLOWERING TOP; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; SODIUM CHLORIDE; BASIL; PHOSPHORUS; PLATINUM; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 57955-1271_1be952e4-760b-4fc9-979f-2afef09fc106 57955-1271 HUMAN OTC DRUG Sexual Identity Ammonium muriaticum, Conium maculatum, Ignatia amara, Juglans regia, flos, Mancinella, Natrum muriaticum, Ocimum basilicum, Phosphorus, Platinum metallicum, Sepia, Staphysagria, Thuja occidentalis LIQUID ORAL 20131210 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CHLORIDE; CONIUM MACULATUM FLOWERING TOP; STRYCHNOS IGNATII SEED; JUGLANS REGIA FLOWERING TOP; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; SODIUM CHLORIDE; BASIL; PHOSPHORUS; PLATINUM; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1500_cccd09ea-09cf-4d14-90ed-d8d1f1956313 57955-1500 HUMAN OTC DRUG Apathy Adrenalinum, Bromus ramosus, flos, Calcarea iodata, Capsicum annuum, Carduus marianus, Carpinus betulus, flos, Chelidonium majus, Chionanthus virginica, Cinchona officinalis, Cytisus Scoparius, Juglans regia, flos, Mentha piperita, Oxytropis lambertii, Parthenium, Phosphoricum acidum, Picricum acidum, Saponaria officinalis, Scleranthus annuus, flos, Zincum metallicum LIQUID ORAL 20130701 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; BROMUS RAMOSUS FLOWER; CALCIUM IODIDE; CAPSICUM; SILYBUM MARIANUM SEED; CARPINUS BETULUS FLOWERING TOP; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CYTISUS SCOPARIUS FLOWERING TOP; JUGLANS REGIA FLOWERING TOP; MENTHA PIPERITA; OXYTROPIS LAMBERTII TOP; PARTHENIUM HYSTEROPHORUS; PHOSPHORIC ACID; PICRIC ACID; SAPONARIA OFFICINALIS ROOT; SCLERANTHUS ANNUUS FLOWERING TOP; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1503_f7c1282f-fcc0-4f28-8b9f-202abac59211 57955-1503 HUMAN OTC DRUG Bladder Formula Aesculus hippocastanum, apis mellifica, Benzoicum acidum, Causticum, Equisetum hyemale, Lycopodium clavatum, Phosphorus, Plantago major, Rhus aromatica, Sepia LIQUID ORAL 20140430 UNAPPROVED HOMEOPATHIC King Bio Inc. HORSE CHESTNUT; APIS MELLIFERA; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1504_3672bed2-4d55-4b34-993f-6762695423e7 57955-1504 HUMAN OTC DRUG Apathy Adrenalinum, Bromus ramosus, flos, Calcarea iodata, Capsicum annuum, Carduus marianus, Carpinus betulus, flos, Chelidonium majus, Chionanthus virginica, Cinchona officinalis, Cytisus scoparius, Juglans regia, flos, Mentha piperita, Oxytropis lambertii, Parthenium, Phosphoricum acidum, Picricum acidum, Saponaria officinalis, Scleranthus annuus, flos, Zincum metallicum LIQUID ORAL 20141020 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; BROMUS RAMOSUS FLOWER; CALCIUM IODIDE; CAPSICUM; MILK THISTLE; CARPINUS BETULUS FLOWERING TOP; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; CYTISUS SCOPARIUS FLOWERING TOP; JUGLANS REGIA FLOWERING TOP; MENTHA PIPERITA; OXYTROPIS LAMBERTII TOP; PARTHENIUM HYSTEROPHORUS; PHOSPHORIC ACID; PICRIC ACID; SAPONARIA OFFICINALIS ROOT; SCLERANTHUS ANNUUS FLOWERING TOP; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1511_29046827-4963-45cf-a5f5-492856b0f158 57955-1511 HUMAN OTC DRUG Hyperactive Adrenalinum, Allium sativum, Anethum graveolens, Arsenicum album, Arsenicum iodatum, Asafoetida, Belladonna, Cereus bonplandii, Chamomilla, Coffea cruda, Erodium, Impatiens glandulifera, flos, Iodium, Mandragora officinarum, Solidago virgaurea, Thyroidinum LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; GARLIC; DILL; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; ASAFETIDA; ATROPA BELLADONNA; HARRISIA POMANENSIS STEM; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; ERODIUM CICUTARIUM; IMPATIENS GLANDULIFERA FLOWER; IODINE; MANDRAGORA OFFICINARUM ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1520_a352e56f-7846-434e-b7db-fdc101274d15 57955-1520 HUMAN PRESCRIPTION DRUG Sluggish Mind Adrenalinum, Agnus Castus, Ailanthus glandulosus, Aletris farinosa, Anethum graveolens, Bromus ramosus, flos, Caladium seguinum, Carpinus betulus, flos, Clematis vitalba, flos, Clematis vitalba, flos, Conium maculatum, Helleborus niger, Conium maculatum, Helleborus niger, Hypericum perforatum, Lecithin, Mentha piperita, Natrum carbonicum, Olea europaea, flos, Oleander, Phosphoricum acidum, Plumbum metallicum, Tropaeolum majus, Xerophyllum asphodeloides, Zincum metallicum LIQUID ORAL 20130226 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; CHASTE TREE; AILANTHUS ALTISSIMA FLOWERING TWIG; ALETRIS FARINOSA ROOT; DILL; BROMUS RAMOSUS FLOWER; DIEFFENBACHIA SEGUINE; CARPINUS BETULUS FLOWERING TOP; CLEMATIS VITALBA FLOWER; CONIUM MACULATUM FLOWERING TOP; HELLEBORUS NIGER ROOT; HYPERICUM PERFORATUM; EGG PHOSPHOLIPIDS; MENTHA PIPERITA; SODIUM CARBONATE; OLEA EUROPAEA FLOWER; NERIUM OLEANDER LEAF; PHOSPHORIC ACID; LEAD; TROPAEOLUM MAJUS; XEROPHYLLUM ASPHODELOIDES; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 57955-1521_47257b73-bde1-4ef5-ae08-ac3245802b80 57955-1521 HUMAN OTC DRUG Sluggish Mind Adrenalinum, Agnus castus, Ailanthus glandulosus, Aletris farinosa, Anethum graveolens, Bromus ramosus, flos, Caladium seguinum, Carpinus betulus, flos, Clematis vitalba, flos, Conium maculatum, Helleborus niger, Hypericum perforatum, Lecithin, Mentha piperita, Natrum carbonicum, Olea europaea, flos, Oleander, Phosphoricum acidum, Plumbum metallicum, Tropaeolum majus, Xerophyllum asphodeloides, Zincum metallicum LIQUID ORAL 20161128 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; CHASTE TREE; AILANTHUS ALTISSIMA FLOWERING TWIG; ALETRIS FARINOSA ROOT; DILL; BROMUS RAMOSUS FLOWER; DIEFFENBACHIA SEGUINE; CARPINUS BETULUS FLOWERING TOP; CLEMATIS VITALBA FLOWER; CONIUM MACULATUM FLOWERING TOP; HELLEBORUS NIGER ROOT; HYPERICUM PERFORATUM; EGG PHOSPHOLIPIDS; MENTHA PIPERITA; SODIUM CARBONATE; OLEA EUROPAEA FLOWER; NERIUM OLEANDER LEAF; PHOSPHORIC ACID; LEAD; TROPAEOLUM MAJUS; XEROPHYLLUM ASPHODELOIDES; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1530_bdf86f94-8de0-4c73-b13e-48d69b4c48d4 57955-1530 HUMAN PRESCRIPTION DRUG Restless Mind Aconitum ferox, Adrenalinum, Aesculus hippocastanum, flos, Apis mellifica, Argentum nitricum, Avena sativa, Baptisia tinctoria, Mentha piperita, Myosotis arvensis, Phosphorus, Ranunculus bulbosus, Scleranthus annuus, flos, Scutellaria lateriflora, Sumbul, Thyroidinum, Verbena officinalis, flos, Viola odorata LIQUID ORAL 20130228 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM FEROX ROOT; EPINEPHRINE; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; SILVER NITRATE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; MENTHA PIPERITA; MYOSOTIS ARVENSIS; PHOSPHORUS; RANUNCULUS BULBOSUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; FERULA SUMBUL ROOT; THYROID, UNSPECIFIED; VERBENA OFFICINALIS FLOWERING TOP; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 57955-1531_ae71aa91-09fc-4aa9-b335-08c4b9d58c92 57955-1531 HUMAN OTC DRUG Restless Mind Aconitum ferox, Adrenalinum, Aesculus hippocastanum, flos, Apis mellifica, Argentum nitricum, Avena sativa, Baptisia tinctor, Mentha piperita, Myosotis arvensis, Phosphorus, Ranunculus bulbosus, Scleranthus annuus, flos, Scutellaria lateriflora, Sumbul, Thyroidinum, Verbena officinalis, flos, Viola odorata LIQUID ORAL 20131219 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM FEROX ROOT; EPINEPHRINE; AESCULUS HIPPOCASTANUM FLOWER; APIS MELLIFERA; SILVER NITRATE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; MENTHA PIPERITA; MYOSOTIS ARVENSIS; PHOSPHORUS; RANUNCULUS BULBOSUS; SCLERANTHUS ANNUUS FLOWERING TOP; SCUTELLARIA LATERIFLORA; FERULA SUMBUL ROOT; THYROID, UNSPECIFIED; VERBENA OFFICINALIS FLOWERING TOP; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1541_3f63e59f-87ba-48ff-8cd0-883db9f1afcf 57955-1541 HUMAN OTC DRUG Spaced out Asarum europaeum, Clematis erecta, Clematis vitalba, flos, cocculus indicus, Lathyrus sativus, Lonicera caprifolium, flos, Millefolium, Naja tripudians, Nux moschata, Oleander, Rosa damascena, Rosmarinus officinalis, Stigmata maidis, Sulphur LIQUID ORAL 20140407 UNAPPROVED HOMEOPATHIC King Bio Inc. ASARUM EUROPAEUM; CLEMATIS RECTA FLOWERING TOP; CLEMATIS VITALBA FLOWER; ANAMIRTA COCCULUS SEED; LATHYRUS SATIVAS SEED; LONICERA CAPRIFOLIUM FLOWERING TOP; ACHILLEA MILLEFOLIUM; NAJA NAJA VENOM; NUTMEG; NERIUM OLEANDER LEAF; ROSA DAMASCENA FLOWERING TOP; ROSMARINUS OFFICINALIS FLOWERING TOP; CORN SILK; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1561_b5e10703-f6cb-45a0-9935-07864dd087d5 57955-1561 HUMAN OTC DRUG Mental Alertness For Seniors Agnus castus, Aletris farinosa, Alumina, Avena sativa, Carpinus betulus, flos, Clematis vitalba, flos, Conium maculatum, Lecithin, Mentha piperita, Nux moschata, Olea europaea, flos, Picricum acidum, Plumbum metallicum, Zincum metallicum LIQUID ORAL 20140602 UNAPPROVED HOMEOPATHIC King Bio Inc. CHASTE TREE; ALETRIS FARINOSA ROOT; ALUMINUM OXIDE; AVENA SATIVA FLOWERING TOP; CARPINUS BETULUS FLOWERING TOP; CLEMATIS VITALBA FLOWER; CONIUM MACULATUM FLOWERING TOP; EGG PHOSPHOLIPIDS; MENTHA PIPERITA; NUTMEG; OLEA EUROPAEA FLOWER; PICRIC ACID; LEAD; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1700_5eb1b9b5-da59-4d81-9b9e-5e474f80f783 57955-1700 HUMAN OTC DRUG Allergies Formula Allium cepa, Ambrosia artemisiaefolia, Dulcamara, Euphrasia officinalis, Histaminum hydrochloricum, Kali muriaticum, Naphthalinum, Natrum muriaticum LIQUID ORAL 20140120 UNAPPROVED HOMEOPATHIC King Bio Inc. ONION; AMBROSIA ARTEMISIIFOLIA; SOLANUM DULCAMARA TOP; EUPHRASIA STRICTA; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; NAPHTHALENE; SODIUM CHLORIDE 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1751_5939f149-7f2b-48bb-9290-388ea569e234 57955-1751 HUMAN OTC DRUG Intense Anxiety Aconitum napellus, Aethusa cynapium, Argentum nitricum, Arsenicum album, Borago officinalis, Bryonia, Castanea sativa, flos, Cytisus scoparius, Digitalis purpurea, Eriodictyon californicum, Jatropha curcas, Laurocerasus, Lolium temulentum, Mancinella, Murex purpurea, Rhus toxicodendron, Sinapis arvensis, flos, Spongia tosta LIQUID ORAL 20140113 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AETHUSA CYNAPIUM; SILVER NITRATE; ARSENIC TRIOXIDE; BORAGE; BRYONIA ALBA ROOT; CASTANEA SATIVA FLOWER; CYTISUS SCOPARIUS FLOWERING TOP; DIGITALIS; ERIODICTYON CALIFORNICUM LEAF; JATROPHA CURCAS SEED; PRUNUS LAUROCERASUS LEAF; LOLIUM TEMULENTUM TOP; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; TOXICODENDRON PUBESCENS LEAF; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1770_396da866-fd61-4f45-9491-ad033bbeb03e 57955-1770 HUMAN OTC DRUG First Aid for Mind and Body Aconitum napellus, Apis mellifica, Arnica montana, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Cistus canadensis, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Impatiens glandulifera, flos, ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, sulphur, Symphytum officinale, Trifolium pratense, Veratrum album LIQUID ORAL 20140401 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; CLEMATIS VITALBA FLOWER; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF; SULFUR; COMFREY ROOT; TRIFOLIUM PRATENSE FLOWER; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1791_4afe16fb-0d5f-44fe-957a-1035b79a4f7c 57955-1791 HUMAN OTC DRUG Fear and Phobia Abelmoschus, Aconitum napellus, Allium sativum, Arsenicum album, Calcarea carbonica, Chamomilla, Cocculus indicus, Erodium, Gelsemium sempervirens, Hypericum perforatum, Kali arsenicosum, Lilium tigrinum, Mimulus guttatus, flos, Phosphorus, Populus tremula, flos, Pulsatilla, Stramonium, Symphytum officinale, Ulmus procera, flos LIQUID ORAL 20131210 UNAPPROVED HOMEOPATHIC King Bio Inc. ABELMOSCHUS MOSCHATUS SEED; ACONITUM NAPELLUS; GARLIC; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; ANAMIRTA COCCULUS SEED; ERODIUM CICUTARIUM; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; POTASSIUM ARSENITE ANHYDROUS; LILIUM LANCIFOLIUM WHOLE FLOWERING; MIMULUS GUTTATUS FLOWERING TOP; PHOSPHORUS; POPULUS TREMULA FLOWERING TOP; PULSATILLA VULGARIS; DATURA STRAMONIUM; COMFREY ROOT; ULMUS PROCERA FLOWERING TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1800_64fc245d-e7e1-4c0a-ae08-909dd402024d 57955-1800 HUMAN OTC DRUG Hypochondria Aconitum napellus, Allium sativum, Antimonium tartaricum, Arnica montana, Asafoetida, Cactus grandiflorus, Chamomilla, Erodium, Gratiola officinalis, Hypericum perforatum, Mezereum, Mimulus guttatus, flos, Petroleum, Phosphorus, Populus tremula, flos, Stannum metallicum, Staphysagria, Symphytum officinale, Ulmus procera, flos LIQUID ORAL 20130808 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; GARLIC; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ASAFETIDA; SELENICEREUS GRANDIFLORUS STEM; MATRICARIA RECUTITA; ERODIUM CICUTARIUM; GRATIOLA OFFICINALIS; HYPERICUM PERFORATUM; DAPHNE MEZEREUM BARK; MIMULUS GUTTATUS FLOWERING TOP; KEROSENE; PHOSPHORUS; POPULUS TREMULA FLOWERING TOP; TIN; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ULMUS PROCERA FLOWERING TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1801_85e137c5-00cb-40d5-96e6-7a90661bede4 57955-1801 HUMAN OTC DRUG Multi-Strain Flu Relief Anas barbariae, hepatis et cordis extractum, Arsenicum album, Baptisia tinctoria, Bryonia, Causticum, Cinchona officinalis, Echinacea purpurea, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Influenzinum, Phytolacca decandra, Rhus toxicodendron, Sarcolacticum acidum, Sulphur, Wyethia helenioides, Zincum aceticum, Zincum muriaticum, Zincum oxydatum LIQUID ORAL 20140822 UNAPPROVED HOMEOPATHIC King Bio Inc. CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; WYETHIA HELENIOIDES ROOT; ZINC ACETATE ANHYDROUS; ZINC CHLORIDE; ZINC OXIDE 35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1802_3884072f-7b0a-4b4f-9351-3e1f28ce8c6d 57955-1802 HUMAN OTC DRUG Candida High Potency 9 Abies canadensis, Allium cepa, Allium sativum, Aloe socotrina, Antimonium crudum, Asafoetida, Borax, Candida albicans, Candida parapsilosie, Ignatia amara, Lachesis mutus, Lycopodium clavatum, Phosphoricum acidum, Phytolacca decandra, Pulsatilla, Sabadilla, Sticta pulmonaria, Sulphur, Thuja occidentalis LIQUID ORAL 20140714 UNAPPROVED HOMEOPATHIC King Bio Inc. TSUGA CANADENSIS BARK; TSUGA CANADENSIS FLOWER BUD; ONION; GARLIC; ALOE; ANTIMONY TRISULFIDE; ASAFETIDA; SODIUM BORATE; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL N 20181231 57955-1803_2d6a56c6-3d77-478d-a83e-cad3b91adfdd 57955-1803 HUMAN OTC DRUG BronchialCare Soins Des Bronches Aconitum napellus, Adrenalinum, Ammonium carbonicum, Antimonium tartaricum, Aralia racemosa, Bromium, Chlorinum, Eriodictyon californicum, Eucalyptus globulus, Grindelia, Lobelia inflata, Natrum sulphuricum, Phosphorus, Quebracho, Trifolium pratense LIQUID ORAL 20140806 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; EPINEPHRINE; AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; BROMINE; CHLORINE; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; GRINDELIA HIRSUTULA FLOWERING TOP; LOBELIA INFLATA; SODIUM SULFATE; PHOSPHORUS; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; TRIFOLIUM PRATENSE FLOWER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1804_ef0ac0d3-b319-4ff8-94d3-825ebdf99a8c 57955-1804 HUMAN OTC DRUG Arthritis Pain and Joint Relief / Soulagement De La Douleur Arthritique Et Articulaire Actaea spicata, Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Ledum palustre, Lithium carbonicum, Magnesia phosphorica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus toxicodendron, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum LIQUID ORAL 20140806 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTAEA SPICATA ROOT; HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1805_ad734932-5b15-4e10-98cd-bb002a849e8d 57955-1805 HUMAN OTC DRUG Stress Control / Controle Du Stress Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Clematis erecta, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Passiflora incarnata, Phosphorus, Rhus toxicodendron, Sulphur, Symphytum officinale, Veratrum album LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CLEMATIS RECTA FLOWERING TOP; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SULFUR; COMFREY ROOT; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1806_06115262-049f-4b87-899f-5868701b7b72 57955-1806 HUMAN OTC DRUG Respiratory Care / Congestion Pulmonaire Et Bronchique Ammonium carbonicum, Antimonium tartaricum, Carbo vegetabilis, Chlorinum, Kali carbonicum, Lobelia inflata, Phosphorus, silicea, Stannum metallicum LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; ACTIVATED CHARCOAL; CHLORINE; POTASSIUM CARBONATE; LOBELIA INFLATA; PHOSPHORUS; SILICON DIOXIDE; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1807_283f4df0-63b7-4f2a-b70e-9a05051e298e 57955-1807 HUMAN OTC DRUG Hypochondria Aconitum napellus, Allium sativum, Antimonium tartaricum, Arnica montana, Asafoetida, Cactus grandiflorus, Chamomilla, Erodium, Gratiola officinalis, Hypericum perforatum, Mezereum, Mimulus guttatus, flos, Petroleum, Phosphorus, Populus tremula, flos, Stannum metallicum, Staphysagria, Symphytum officinale, Ulmus procera, flos LIQUID ORAL 20141020 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; GARLIC; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ASAFETIDA; SELENICEREUS GRANDIFLORUS STEM; MATRICARIA RECUTITA; ERODIUM CICUTARIUM; GRATIOLA OFFICINALIS; HYPERICUM PERFORATUM; DAPHNE MEZEREUM BARK; MIMULUS GUTTATUS FLOWERING TOP; KEROSENE; PHOSPHORUS; POPULUS TREMULA FLOWERING TOP; TIN; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ULMUS PROCERA FLOWERING TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1810_94fb6aaa-a0b6-463f-bea0-b2f488a6d468 57955-1810 HUMAN OTC DRUG Fears and Nightmares Aconitum napellus, Aesculus carnea, flos, Allium sativum, Aurum bromatum, Calcarea carbonica, Chamomilla, Cina, Helianthemum nummularium, flos, Ignatia amara, Kali bromatum, Lycopodium clavatum, Mimulus guttatus, flos, Paeonia officinalis, Phosphorus, Populus tremula, flos, Phus toxicodendron, Stramonium, Sulphur, Viola odorata LIQUID ORAL 20130808 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AESCULUS CARNEA FLOWER; GARLIC; GOLD TRIBROMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; ARTEMISIA CINA PRE-FLOWERING TOP; HELIANTHEMUM NUMMULARIUM FLOWER; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; MIMULUS GUTTATUS FLOWERING TOP; PAEONIA OFFICINALIS ROOT; PHOSPHORUS; POPULUS TREMULA FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; DATURA STRAMONIUM; SULFUR; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1821_fa5125aa-3e96-477f-a6da-510dab2ed5d8 57955-1821 HUMAN OTC DRUG Claustrophobia Aconitum napellus, Angelica archangelica, Argentum nitricum, Arnica montana, Calendula officinalis, Cimicifuga racemosa, Cistus canadensis, Clematis vitalba, flos, Hypericum perforatum, Impatiens glandulifera, flos, Nitricum acidum, Ornithogalum umbellatum, Prunus cerasifera, flos, Pulsatilla LIQUID ORAL 20131210 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ANGELICA ARCHANGELICA ROOT; SILVER NITRATE; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; BLACK COHOSH; HELIANTHEMUM CANADENSE; CLEMATIS VITALBA FLOWER; HYPERICUM PERFORATUM; IMPATIENS GLANDULIFERA FLOWER; NITRIC ACID; ORNITHOGALUM UMBELLATUM; PRUNUS CERASIFERA FLOWER; PULSATILLA VULGARIS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1822_7209b2cd-bd6d-4415-bd2e-a5d362981667 57955-1822 HUMAN OTC DRUG Claustrophobia Aconitum napellus, Angelica archangelica, Argentum nitricum, Calendula officinalis, Chamomilla, Cimicifuga racemosa, Hypericum perforatum, Lobelia cardinalis, Malus pumila, flos, Millefolium, Nitricum acidum, Pulsatilla, Salvia officinalis LIQUID ORAL 20161202 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ANGELICA ARCHANGELICA ROOT; SILVER NITRATE; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; BLACK COHOSH; HYPERICUM PERFORATUM; LOBELIA CARDINALIS; MALUS DOMESTICA FLOWER; ACHILLEA MILLEFOLIUM; NITRIC ACID; PULSATILLA VULGARIS; SAGE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1830_e8dbefd8-6d4e-4e5e-9c52-dda756bd070d 57955-1830 HUMAN PRESCRIPTION DRUG Obsessions/Compulsions Arsenicum album, Arsenicum iodatum, Calcarea carbonica, Coffea cruda, Cytisus scoparius, Iodium, Mancinella, Mentha poperita, Physostigma venenosum, Silicea, Ulmus procera, flos, Verbascum thapsus LIQUID ORAL 20130225 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; CYTISUS SCOPARIUS FLOWERING TOP; IODINE; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; MENTHA PIPERITA; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE; ULMUS PROCERA FLOWERING TWIG; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 57955-1831_d405c8e4-9e75-461a-a603-552e3fa9cb62 57955-1831 HUMAN OTC DRUG Obsessions/Compulsions Arsenicum album, Arsenicum iodatum, Calcarea carbonica, Coffea cruda, Cytisus scoparius, Iodium, Mancinella, Mentha piperita, Physostigma venenosum, Silicea, Ulmus procera, flos, Verbascum thapsus LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; CYTISUS SCOPARIUS FLOWERING TOP; IODINE; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; MENTHA PIPERITA; PHYSOSTIGMA VENENOSUM SEED; SILICON DIOXIDE; ULMUS PROCERA FLOWERING TWIG; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1840_7229d38d-89a5-42a7-bcb5-b58411a5874d 57955-1840 HUMAN OTC DRUG Perfectionism Aceticum acidum, Borago officinalis, Cereus bonplandii, Cyclamen europaeum, Ignatia amara, Passiflora incarnata, Silicea, Sinapis arvensis, flos, Spiraea ulmaria, Staphysagria, Strontium carbonicum, Tropaeolum majus LIQUID ORAL 20130701 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; BORAGE; HARRISIA POMANENSIS STEM; CYCLAMEN PURPURASCENS TUBER; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; FILIPENDULA ULMARIA ROOT; DELPHINIUM STAPHISAGRIA SEED; STRONTIUM CARBONATE; TROPAEOLUM MAJUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1850_85b00476-479d-4ac5-be53-a889d7063301 57955-1850 HUMAN PRESCRIPTION DRUG Stress Control Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Clematis erecta, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, Ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, sulphur, Symphytum officinale, Veratrum album LIQUID ORAL 20130415 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CLEMATIS RECTA FLOWERING TOP; CLEMATIS VITALBA FLOWER; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF; SULFUR; COMFREY ROOT; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC] N 20181231 57955-1851_2634b232-2f55-42b6-acd4-252250a6a8f8 57955-1851 HUMAN OTC DRUG Stress Control Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Clematis erecta, Clematis vitalba, flos, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, Ornithogalum umbellatum, flos, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, Sulphur, Symphytum officinale, Veratrum album LIQUID ORAL 20131217 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CLEMATIS RECTA FLOWERING TOP; CLEMATIS VITALBA FLOWER; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF; SULFUR; COMFREY ROOT; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1903_65ec3e08-bc72-4545-81ec-9185cdf3dc3a 57955-1903 HUMAN OTC DRUG Better Breath Arnica montana, Arsenicum album, Aurum metallicum, Baptisia tinctoria, Calcarea carbonica, Calcarea fluorica, Carbo vegetabilis, Carbolicum acidum, Gambogia, Hekla lava, Iodium, Kali phosphoricum, Kreosotum, Mercurius corrosivus, Mercurius vivus, Nitricum acidum, Petroleum, Quercus robur, Staphysagria, Sulphur LIQUID ORAL 20140505 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; ARSENIC TRIOXIDE; GOLD; BAPTISIA TINCTORIA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; ACTIVATED CHARCOAL; PHENOL; GAMBOGE; HEKLA LAVA; IODINE; POTASSIUM PHOSPHATE, DIBASIC; WOOD CREOSOTE; MERCURIC CHLORIDE; MERCURY; NITRIC ACID; KEROSENE; QUERCUS ROBUR TWIG BARK; DELPHINIUM STAPHISAGRIA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-1904_f82a5db9-c2ef-4a19-9d69-8a1bdc4f467d 57955-1904 HUMAN OTC DRUG Dental Plak Baptisia tinctoria, Calcarea carbonica, Carbo vegetabilis, Kreosotum, Magnesia phosphorica, Mercurius vivus, Phosphorus, Sulphur LIQUID ORAL 20140505 UNAPPROVED HOMEOPATHIC King Bio Inc. BAPTISIA TINCTORIA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; WOOD CREOSOTE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURY; PHOSPHORUS; SULFUR 10; 10; 10; 10; 10; 10; 10; 10 1/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2010_2c24549c-b54b-44e4-b9e3-ee04910654d8 57955-2010 HUMAN OTC DRUG Melancholic Alfalfa, Ammonium carbonicum, Anethum graveolens, Antimonium crudum, Aurum metallicum, Benzoicum acidum, Berberis aquifolium, Fagus sylvatica, flos, Ilex aquifolium, flos, Lycopodium clavatum, Millefolium, Muriaticum acidum, Psorinum, Salix vitellina, flos LIQUID ORAL 20130820 UNAPPROVED HOMEOPATHIC King Bio Inc. ALFALFA; AMMONIUM CARBONATE; DILL; ANTIMONY TRISULFIDE; GOLD; BENZOIC ACID; MAHONIA AQUIFOLIUM ROOT BARK; FAGUS SYLVATICA FLOWERING TOP; ILEX AQUIFOLIUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; ACHILLEA MILLEFOLIUM; HYDROCHLORIC ACID; SCABIES LESION LYSATE (HUMAN); SALIX ALBA FLOWERING TOP 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2011_8f55da39-011a-414d-9163-96ddc02539d9 57955-2011 HUMAN OTC DRUG Melancholic Alfalfa, Ammonium carbonicum, Anethum graveolens, Antimonium crudum, Aurum metallicum, Benzoicum acidum, Berberis aquifolium, Fagus sylvatica, flos, Ilex aquifolium, flos, Lycopodium clavatum, Millefolium, Muriaticum acidum, Psorinum, Salix vitellina, flos. LIQUID ORAL 20170310 UNAPPROVED HOMEOPATHIC King Bio, Inc. ALFALFA; AMMONIUM CARBONATE; DILL; ANTIMONY TRISULFIDE; GOLD; BENZOIC ACID; MAHONIA AQUIFOLIUM ROOT BARK; FAGUS SYLVATICA FLOWERING TOP; ILEX AQUIFOLIUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; ACHILLEA MILLEFOLIUM; HYDROCHLORIC ACID; SCABIES LESION LYSATE (HUMAN); SALIX ALBA FLOWERING TOP 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2021_77eeed2e-a04e-4d7e-8a1a-468c8bcaf138 57955-2021 HUMAN OTC DRUG Mood Changes Agrimonia eupatoria, flos, Anacardium orientale, Aurum metallicum, Eriodictyon californicum, Hyoscyamus niger, Lachesis mutus, Larix decidua, flos, Mimulus guttatus, flos, Pulsatilla, Staphysagria, Stramonium, Taraxacum officinale, Tarentula hispana LIQUID ORAL 20150803 UNAPPROVED HOMEOPATHIC King Bio Inc. AGRIMONIA EUPATORIA FLOWER; SEMECARPUS ANACARDIUM JUICE; GOLD; ERIODICTYON CALIFORNICUM LEAF; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; LARIX DECIDUA FLOWERING TOP; MIMULUS GUTTATUS FLOWERING TOP; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; TARAXACUM OFFICINALE; LYCOSA TARANTULA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2030_7715ac5b-1e4c-4ed1-a192-521a165dbead 57955-2030 HUMAN OTC DRUG Heart Ache Aloe socotrina, Ambra grisea, Ammonium muriaticum, Antimonium crudum, Aurum metallicum, Borago officinalis, Cichorium intybus, flos, Cimicifuga racemosa, Eriodictyon californicum, Ignatia amara, Ilex aquifolium, flos, Iodium, Natrum muriaticum, Phosphoricum acidum, Rosa damascena, Stannum metallicum, Tilia europaea LIQUID ORAL 20130812 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; AMBERGRIS; AMMONIUM CHLORIDE; ANTIMONY TRISULFIDE; GOLD; BORAGE; CICHORIUM INTYBUS FLOWER; BLACK COHOSH; ERIODICTYON CALIFORNICUM LEAF; STRYCHNOS IGNATII SEED; ILEX AQUIFOLIUM FLOWERING TOP; IODINE; SODIUM CHLORIDE; PHOSPHORIC ACID; ROSA DAMASCENA FLOWERING TOP; TIN; TILIA X EUROPAEA FLOWER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2040_d51fa8b4-2d8c-477c-9b1e-3e8db5f483d0 57955-2040 HUMAN PRESCRIPTION DRUG Chagrined Allium sativum, Argentum nitricum, Asafoetida, Calendula officinalis, Capsicum annuum, Ceanothus americanus, Colocynthis, Ignatia amara, Lachesis mutus, Lobelia cardinalis, Nux vomica, Pinus sylvestris, flos, Solidago virgaurea, Taraxacum officinale LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC King Bio Inc. GARLIC; SILVER NITRATE; ASAFETIDA; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; CEANOTHUS AMERICANUS LEAF; CITRULLUS COLOCYNTHIS FRUIT PULP; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; LOBELIA CARDINALIS; STRYCHNOS NUX-VOMICA SEED; PINUS SYLVESTRIS FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 57955-2050_bb652043-d781-4c98-b8d9-3b231864009c 57955-2050 HUMAN PRESCRIPTION DRUG Guilt Agrimonia eupatoria, flos, Arsenicum album, Ceratostigma willmottianum, flos, cuprum metallicum, Cyclamen europaeum, Digitalis purpurea, Ignatia amara, Juglans regia, flos, Millefolium, Natrum muriaticum, Phosphoricum acidum, Pinus sylvestris, flos, Thuja occidentalis, Verbascum thapsus LIQUID ORAL 20130516 UNAPPROVED HOMEOPATHIC King Bio Inc. AGRIMONIA EUPATORIA FLOWER; ARSENIC TRIOXIDE; CERATOSTIGMA WILLMOTTIANUM FLOWER; COPPER; CYCLAMEN PURPURASCENS TUBER; DIGITALIS; STRYCHNOS IGNATII SEED; JUGLANS REGIA FLOWERING TOP; ACHILLEA MILLEFOLIUM; SODIUM CHLORIDE; PHOSPHORIC ACID; PINUS SYLVESTRIS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] N 20181231 57955-2051_4c00b2cd-9596-44ff-afca-d2be07bcc2c5 57955-2051 HUMAN OTC DRUG Guilt Agrimonia eupatoria, flos, Arsenicum album, Ceratostigma willmottianum, flos, Cuprum metallicum, Cyclamen europaeum, Digitalis purpurea, Ignatia amara, Juglans regia, flos, Millefolium, Natrum muriaticum, Phosphoricum acidum, Pinus sylvestris, Thuja occidentalis, Verbascum thapsus LIQUID ORAL 20140124 UNAPPROVED HOMEOPATHIC King Bio Inc. AGRIMONIA EUPATORIA FLOWER; ARSENIC TRIOXIDE; CERATOSTIGMA WILLMOTTIANUM FLOWER; COPPER; CYCLAMEN PURPURASCENS TUBER; DIGITALIS; STRYCHNOS IGNATII SEED; JUGLANS REGIA FLOWERING TOP; ACHILLEA MILLEFOLIUM; SODIUM CHLORIDE; PHOSPHORIC ACID; PINUS SYLVESTRIS LEAFY TWIG; THUJA OCCIDENTALIS LEAFY TWIG; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2061_1fc5b4fd-e05e-4bb4-b5b3-8790db710423 57955-2061 HUMAN OTC DRUG Grief Ammonium muriaticum, Apis mellifica, Aurum metallicum, Borago officinalis, Causticum, Eriodictyon californicum, Gelsemium sempervirens, Ignatia amara, Natrum muriaticum, Ornithogalum umbellatum, flos, Phosphoricum acidum, Pinus sylvestris, flos, Rosa damascena, Taraxacum officinale LIQUID ORAL 20140718 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CHLORIDE; APIS MELLIFERA; GOLD; BORAGE; CAUSTICUM; ERIODICTYON CALIFORNICUM LEAF; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PHOSPHORIC ACID; PINUS SYLVESTRIS FLOWERING TOP; ROSA DAMASCENA FLOWERING TOP; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2071_242cc927-0d1e-42db-8b3f-c9c64fe3d8bf 57955-2071 HUMAN OTC DRUG Overly Sensitive Aloe socotrina, Anacardium orientale, Asterias rubens, Aurum metallicum, Carpinus betulus, flos, Chamomilla, Cinchona officinalis, Eriodictyon californicum, Ignatia amara, Lycopodium clavatum, Mentha piperita, Millefolium, Nasturtium aquaticum, Natrum carbonicum, Natrum muriaticum, Palladium metallicum, Petroleum, Ranunculus bulbasus, Sarsaparilla, Sepia, Taraxacum officinale LIQUID ORAL 20131023 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; SEMECARPUS ANACARDIUM JUICE; ASTERIAS RUBENS; GOLD; CARPINUS BETULUS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; ERIODICTYON CALIFORNICUM LEAF; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MENTHA PIPERITA; ACHILLEA MILLEFOLIUM; NASTURTIUM OFFICINALE; SODIUM CARBONATE; SODIUM CHLORIDE; PALLADIUM; KEROSENE; RANUNCULUS BULBOSUS; SMILAX REGELII ROOT; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2080_2ac11f74-f97d-4c77-ad4e-16c39b21d0bf 57955-2080 HUMAN OTC DRUG Good Mood Enhancer Agrimonia eupatoria, flos, Anacardium orientale, Aurum metallicum, Avena sativa, Borago officinalis, Calcarea carbonica, Capsicum annuum, Carpinus betulus, flos, Cimicifuga racemosa, Cinchona officinalis, Hypericum perforatum, Ignatia amara, Kali bromatum, Larix decidua, flos, Natrum carbonicum, Natrum sulphuricum, Phosphoricum acidum, Phosphorus, Pulsatilla, Sepia, Sinapis arvensis, flos, Tabacum LIQUID ORAL 20161028 UNAPPROVED HOMEOPATHIC King Bio Inc. AGRIMONIA EUPATORIA FLOWER; SEMECARPUS ANACARDIUM JUICE; GOLD; AVENA SATIVA FLOWERING TOP; BORAGE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CARPINUS BETULUS FLOWERING TOP; BLACK COHOSH; CINCHONA OFFICINALIS BARK; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; LARIX DECIDUA FLOWERING TOP; SODIUM CARBONATE; SODIUM SULFATE; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 57955-2181_13cb51a8-2237-4a24-89e5-1336a5d2a0be 57955-2181 HUMAN PRESCRIPTION DRUG Appetite and Weight with P.H.A.T. Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, flos, Anacardium orientale, Antimonium crudum, Calcarea carbonica, Castanea sativa, flos, Cortisone aceticum, Fucus vesiculosus, Hypothalamus, Kali bichromicum, Oleander, Pituitarum posterium, Sabadilla, Staphysagria, Thyroidinum LIQUID ORAL 20121212 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; CORTICOTROPIN; AGRIMONIA EUPATORIA FLOWER; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CASTANEA SATIVA FLOWER; CORTISONE ACETATE; FUCUS VESICULOSUS; BOS TAURUS HYPOTHALAMUS; POTASSIUM DICHROMATE; NERIUM OLEANDER LEAF; SUS SCROFA PITUITARY GLAND; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 57955-2196_e2f5a01d-4069-4435-ae94-73564527162b 57955-2196 HUMAN OTC DRUG Allergies Animal Hair and Dander Aralia racemose, Arsenicum album, Histaminum hydrochloricum, Nux vomica, Oleum animale, Phosphorus, Silicea, Sulphur LIQUID ORAL 20140728 UNAPPROVED HOMEOPATHIC King Bio Inc. ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; HISTAMINE DIHYDROCHLORIDE; STRYCHNOS NUX-VOMICA SEED; CERVUS ELAPHUS HORN OIL; PHOSPHORUS; SILICON DIOXIDE; SULFUR 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2197_6c132765-7d99-4aa6-870e-e95d542aadfb 57955-2197 HUMAN OTC DRUG Allergies Dust Mite and Roach Aralia racemosa, Blatta americana, Blatta orientalis, Chelidonium majus, Hydrastis canadensis, Linum usitatissimum, Phosphorus, Sulphur, Trifolium pratense LIQUID ORAL 20140728 UNAPPROVED HOMEOPATHIC King Bio Inc. ARALIA RACEMOSA ROOT; PERIPLANETA AMERICANA; BLATTA ORIENTALIS; CHELIDONIUM MAJUS; GOLDENSEAL; FLAX SEED; PHOSPHORUS; SULFUR; TRIFOLIUM PRATENSE FLOWER 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2198_687350c1-f016-4f09-abb9-d1c69a86d1ba 57955-2198 HUMAN OTC DRUG Allergies Dairy Aethusa cynapium, Anacardium orientale Apium graveolens, Calcarea carbonicum, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lac defloratum, Lac vaccinum, Pulsatilla, Sepia, Sulphur LIQUID ORAL 20150813 UNAPPROVED HOMEOPATHIC King Bio Inc. SEMECARPUS ANACARDIUM JUICE; AETHUSA CYNAPIUM; CELERY SEED; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; SKIM MILK; COW MILK; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2201_b4be05d8-0729-41b6-bdc8-10a3dd8e6d39 57955-2201 HUMAN OTC DRUG Allergies Shellfish and Seafood Adrenalinum, Belladonna, Bromium, Carbo animalis, Colchicum autumnale, Colocynthis, Histaminum hydrochloricum, Hydrastis canadensis, Kali carbonicum, Lycopodium clavatum, Mercurius solubilis, Pulsatilla, Urtica urens LIQUID ORAL 20140727 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; ATROPA BELLADONNA; BROMINE; CARBO ANIMALIS; COLCHICUM AUTUMNALE BULB; CITRULLUS COLOCYNTHIS FRUIT PULP; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; URTICA URENS 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2203_75ebe05d-825a-4ada-9214-0100deceffdc 57955-2203 HUMAN OTC DRUG Allergies Grains and Gluten Arsenicum album, Bryonia, Histaminum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum muriaticum, Pulsatilla, Sabadilla, Secale cornutum, Sulphur LIQUID ORAL 20160405 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; CLAVICEPS PURPUREA SCLEROTIUM; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2204_6a24609b-ef66-4ef9-bbfe-fdce93ee7ed1 57955-2204 HUMAN OTC DRUG Allergies Nuts and Seeds Adrenalinum, Chelidonium majus, Cucurbita pepo semen, Histaminum Hydrochloricum, Hydrastis canadensis, Ricinus communis, Sabadilla LIQUID ORAL 20150727 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; CHELIDONIUM MAJUS; PUMPKIN SEED; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; RICINUS COMMUNIS SEED; SCHOENOCAULON OFFICINALE SEED 12; 12; 12; 12; 12; 12; 12 [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL N 20181231 57955-2205_88b1e817-f859-46ee-afed-b15b89773202 57955-2205 HUMAN OTC DRUG Allergies Fragrances and Phenolics Acetaldehyde, Arsenicum album, Balsamum peruvianum, Calcarea carbonica, Carbolicum acidum, Conium maculatum, Coumarinum, Crocus sativus, Histaminum hydrochloricum, Lachesis mutus, Lycopodium clavatum, Phosphorus, Sepia LIQUID ORAL 20140324 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETALDEHYDE; ARSENIC TRIOXIDE; BALSAM PERU; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENOL; CONIUM MACULATUM FLOWERING TOP; COUMARIN; SAFFRON; HISTAMINE DIHYDROCHLORIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SEPIA OFFICINALIS JUICE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2206_17a549d8-ff08-40c2-9096-c332c0e143f8 57955-2206 HUMAN OTC DRUG Allergies Eggs and Meats Calcarea carbonica, Causticum, Chloramphenicolum, Colchicum autumnale, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Ichthyolum, Lecithin, Ova tosta, Ovi gallinae pellicula, Pulsatilla, Pyrogenium LIQUID ORAL 20140914 UNAPPROVED HOMEOPATHIC King Bio Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; CHLORAMPHENICOL; COLCHICUM AUTUMNALE BULB; GAMBOGE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; ICHTHAMMOL; EGG PHOSPHOLIPIDS; EGG SHELL, COOKED; EGG SHELL MEMBRANE; PULSATILLA VULGARIS; RANCID BEEF 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 14 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2251_419e85d3-42d7-4a32-9989-18765e771cc5 57955-2251 HUMAN OTC DRUG Gossipy Agaricus muscarius, Clematis vitalba, flos, Lachesis mutus, Lathyrus sativus, Lonicera caprifolium, flos, Millefolium, Myristica sebifera, Paris quadrifolia, Pastinaca sativa, Podophyllinum, Pyrogenium, Rosa damascena, Sticta pulmonaria, Stigmata maidis, Stramonium, Veratrum album LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC King Bio Inc. AMANITA MUSCARIA FRUITING BODY; CLEMATIS VITALBA FLOWER; LACHESIS MUTA VENOM; LATHYRUS SATIVAS SEED; LONICERA CAPRIFOLIUM FLOWERING TOP; ACHILLEA MILLEFOLIUM; VIROLA SEBIFERA RESIN; PARIS QUADRIFOLIA; PARSNIP; PODOPHYLLUM RESIN; RANCID BEEF; ROSA DAMASCENA FLOWERING TOP; LOBARIA PULMONARIA; CORN SILK; DATURA STRAMONIUM; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2271_8a59b491-cb9e-4418-b7a2-4f0f1166c55f 57955-2271 HUMAN OTC DRUG Deceitful Argentum metallicum, Angelica archangelica, Asafoetida, Berberis aquifolium, Bismuthum oxydatum, Causticum, Ceanothus americanus, Ceratostigma willmottianum, flos, Cuprum metallicum, Drosera, Hypericum perforatum, Ignatia amara, Ilex aquifolium, flos, Lachesis mutus, Lycopodium clavatum, Nux moschata, Thuja occidentalis, Veratrum album, Verbascum thapsus LIQUID ORAL 20140331 UNAPPROVED HOMEOPATHIC King Bio Inc. SILVER; ANGELICA ARCHANGELICA ROOT; ASAFETIDA; MAHONIA AQUIFOLIUM ROOT BARK; BISMUTH OXIDE; CAUSTICUM; CEANOTHUS AMERICANUS LEAF; CERATOSTIGMA WILLMOTTIANUM FLOWER; COPPER; DROSERA ROTUNDIFOLIA; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; ILEX AQUIFOLIUM FLOWERING TOP; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; NUTMEG; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2281_cfc817d7-50a4-47e9-8333-f79ac862748d 57955-2281 HUMAN OTC DRUG Candida Heavy Metal Detox Aquaflora LIQUID ORAL 20110906 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; BERBERIS VULGARIS ROOT BARK; CADMIUM SULFIDE; CHELIDONIUM MAJUS; CHROMIC OXIDE; COPPER; CYSTEINE; GLYCERIN; GLYCYRRHIZA GLABRA; POTASSIUM CHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; MERCURIC CHLORIDE; MERCURIC CYANIDE; CALOMEL; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; NICKEL; COD LIVER OIL; PHYTOLACCA AMERICANA ROOT; LEAD IODIDE; LEAD; SELENIUM; SOLIDAGO VIRGAUREA FLOWERING TOP; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2282_ea20a8a9-d3b9-4f98-bfb2-0391b254d8be 57955-2282 HUMAN OTC DRUG Reserved Aesculus carnea, flos, Aloe socotrina, Euphorbium officinarum, Fagus sylvatica, flos, Gelsemium sempervirens, Hypericum perforatum, Juglans regia, flos, Kali muriaticum, Magnesia muriatica, Millefolium, Muriaticum acidum, Natrum carbonicum, Phosphoricum acidum, Plumbum metallicum, Sepia, Spongia tosta, Stannum metallicum, Theridion LIQUID ORAL 20140623 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS CARNEA FLOWER; ALOE; EUPHORBIA RESINIFERA RESIN; FAGUS SYLVATICA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; JUGLANS REGIA FLOWERING TOP; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; ACHILLEA MILLEFOLIUM; HYDROCHLORIC ACID; SODIUM CARBONATE; PHOSPHORIC ACID; LEAD; SEPIA OFFICINALIS JUICE; SPONGIA OFFICINALIS SKELETON, ROASTED; TIN; THERIDION CURASSAVICUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2291_4898bdd4-f51d-4c9b-818b-68cc12f44c8f 57955-2291 HUMAN OTC DRUG Immature Agaricus muscarius, Allium sativum, Anethum graveolens, Antimonium crudum, Baryta carbonica, Berberis aquifolium, Bufo rana, Carboneum sulphuratum, Cicuta virosa, Eriodictyon californicum, Erodium, Impatiens glandulifera, flos, Lachesis mutus, Lobelia cardinalis, Lycopodium clavatum, Mimulus guttatus, flos, Moschus, Natrum carbonicum, Solidago virgaurea, Sulphur, Thyroidinum, Rhus toxicodendron, Viola odorata LIQUID ORAL 20131022 UNAPPROVED HOMEOPATHIC King Bio Inc. AMANITA MUSCARIA FRUITING BODY; GARLIC; DILL; ANTIMONY TRISULFIDE; BARIUM CARBONATE; MAHONIA AQUIFOLIUM ROOT BARK; BUFO BUFO CUTANEOUS GLAND; CARBON DISULFIDE; CICUTA VIROSA ROOT; ERIODICTYON CALIFORNICUM LEAF; ERODIUM CICUTARIUM; IMPATIENS GLANDULIFERA FLOWER; LACHESIS MUTA VENOM; LOBELIA CARDINALIS; LYCOPODIUM CLAVATUM SPORE; MIMULUS GUTTATUS FLOWERING TOP; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; SODIUM CARBONATE; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2300_5ce7e375-ef78-4660-bb5b-31dd3211a131 57955-2300 HUMAN OTC DRUG Complaining Anethum graveolens, Arnica montana, Asafoetida, Berberis aquifolium, Bismuthum metallicum, Calcarea phosphorica, Fagus sylvatica, flos, Ilex aquifolium, Lachesis mutus, Salix vitellina, flos, Sulphur, Zincum metallicum LIQUID ORAL 20130827 UNAPPROVED HOMEOPATHIC King Bio Inc. DILL; ARNICA MONTANA; ASAFETIDA; MAHONIA AQUIFOLIUM ROOT BARK; BISMUTH; TRIBASIC CALCIUM PHOSPHATE; FAGUS SYLVATICA FLOWERING TOP; ILEX AQUIFOLIUM FLOWERING TOP; LACHESIS MUTA VENOM; SALIX ALBA FLOWERING TOP; SULFUR; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2311_f9003219-824d-41c5-b561-b66fccd49a5f 57955-2311 HUMAN OTC DRUG Calloused Allium sativum, Anacardium orientale, Calendula officinalis, Capsicum annuum, Ceanothus americanus, Chamomilla, Chelidonium majus, Conium maculatum, Kali carbonicum, Lobelia cardinalis, Mancinella, Myristica sebifera, Pinus sylvestris, flos, Stigmata maidis, Sepia, Taraxacum officinale, Thea sinensis LIQUID ORAL 20140417 UNAPPROVED HOMEOPATHIC King Bio Inc. GARLIC; SEMECARPUS ANACARDIUM JUICE; CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM; CEANOTHUS AMERICANUS LEAF; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; POTASSIUM CARBONATE; LOBELIA CARDINALIS; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; VIROLA SEBIFERA RESIN; PINUS SYLVESTRIS FLOWERING TOP; CORN SILK; SEPIA OFFICINALIS JUICE; TARAXACUM OFFICINALE; GREEN TEA LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2322_2c12444d-b982-4387-b8c0-9c27fade5edf 57955-2322 HUMAN OTC DRUG Prejudiced Ferrum metallicum, Gratiola officinalis, Hamamelis virginiana, Helianthus annuus, Hottonia palustris, flos, Lachesis mutus, Lilium tigrinum, Lycopodium clavatum, Moschus, Palladium metallicum, Platinum metallicum, Rhus toxicodendron, Staphysagria, Sulphur, Veratrum album, Viola odorata LIQUID ORAL 20131212 UNAPPROVED HOMEOPATHIC King Bio Inc. IRON; GRATIOLA OFFICINALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHUS ANNUUS FLOWERING TOP; HOTTONIA PALUSTRIS FLOWER; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; PALLADIUM; PLATINUM; TOXICODENDRON PUBESCENS LEAF; DELPHINIUM STAPHISAGRIA SEED; SULFUR; VERATRUM ALBUM ROOT; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2331_2a4a7d86-85b4-4067-83f6-a044ae803ed1 57955-2331 HUMAN OTC DRUG Extravagant Agrimonia eupatoria, flos, Belladonna, Ceratostigma willmottianum, flos, Cinchona officinalis, Conium maculatum, Curare, Juglans regia, flos, Lachesis mutus, Lilium tigrinum, Palladium metallicum, Pinus sylvestris, flos, Rheum, Salvia officinalis, Verbascum thapsus LIQUID ORAL 20140422 UNAPPROVED HOMEOPATHIC King Bio Inc. AGRIMONIA EUPATORIA FLOWER; ATROPA BELLADONNA; CERATOSTIGMA WILLMOTTIANUM FLOWER; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; TUBOCURARINE CHLORIDE; JUGLANS REGIA FLOWERING TOP; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; PALLADIUM; PINUS SYLVESTRIS FLOWERING TOP; RHEUM OFFICINALE ROOT; SAGE; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2404_3dc6fc43-37e1-42b3-aa72-a21a2bbc72dd 57955-2404 HUMAN OTC DRUG Aller Detox Outdoor Pollution Control Benzinum, Calcarea carbonica, Carbo vegetabilis, Carboneum oxygenisatum, Chlorinum, Chloroforum, Chromium oxydatum, Formalinum, Hekla lava, Hydrastis canadensis, Lycopodium clavatum, Manganum aceticum, Manganum carbonicum, Mercurius vivus, Nitricum acidum, Phosphoricum acidum, Phytolacca decandra, Plumbum iodatum, Plumbum metallicum, Sulphur, Taraxacum LIQUID ORAL 20130610 UNAPPROVED HOMEOPATHIC King Bio Inc. BENZENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; CARBON MONOXIDE; CHLORINE; CHLOROFORM; CHROMIC OXIDE; FORMALDEHYDE; HEKLA LAVA; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MANGANESE ACETATE TETRAHYDRATE; MANGANESE CARBONATE; MERCURY; NITRIC ACID; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; LEAD IODIDE; LEAD; SULFUR; TARAXACUM OFFICINALE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2405_eb95bfed-ed6d-41b3-9fd6-0529788824f1 57955-2405 HUMAN OTC DRUG Aller-Detox Food Additives and Preservatives Formicum acidum, Gambogia, Natrum bicarbonicum, Natrum nitricum, Natrum Nitrosum, Natrum sulphuricum, Nux vomica, Phosphoricum acidum, Phytolacca decandra, Rosa canina, Saccharinum LIQUID ORAL 20130820 UNAPPROVED HOMEOPATHIC King Bio Inc. FORMIC ACID; GAMBOGE; SODIUM BICARBONATE; SODIUM NITRATE; SODIUM NITRITE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; ROSA CANINA FRUIT; SACCHARIN 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2406_8a0b6e9d-7584-484c-adbc-ee7f1ef80426 57955-2406 HUMAN OTC DRUG Aller Detox Herbicides and Pesticides Arsenicum album, Belladonna, Boricum acidum, Calcarea caustica, Carduus marianus, Chelidonium majus, Lycopodium clavatum, Nitricum acidum, Nux vomica, Phosphoricum acidum, Phytolacca decandra, Taraxacum officinale, Trifolium pratense LIQUID ORAL 20120723 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; ATROPA BELLADONNA; BORIC ACID; CALCIUM HYDROXIDE; MILK THISTLE; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2407_22bbcc97-7276-4936-ad48-9d78fc68e0b6 57955-2407 HUMAN OTC DRUG Aller-Detox Cosmetics and Household Adrenalinum, Anacardium orientale, Blatta orientalis, Formalinum, Fumaria officinalis, Glycerinum, Graphites, Magnesia muriatica, Natrum pyruvicum, Nitricum acidum, Phosphorus, Phytolacca decandra, Pituitarum posterium, Pulsatilla, Sulphur LIQUID ORAL 20131001 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; SEMECARPUS ANACARDIUM JUICE; BLATTA ORIENTALIS; FORMALDEHYDE; FUMARIA OFFICINALIS FLOWERING TOP; GLYCERIN; GRAPHITE; MAGNESIUM CHLORIDE; SODIUM PYRUVATE; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SUS SCROFA PITUITARY GLAND; PULSATILLA VULGARIS; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2408_b696bb18-fd07-4e44-a0f3-e84121c23e0e 57955-2408 HUMAN OTC DRUG Aller-Detox Indoor Pollution Control Acetaldehyde, Ammonium causticum, Carboneum oxygenisatum, Chloroformum, Formalinum, Hydrastis canadensis, Glycyrrhiza glabra, Kali bichromicum, Lycopodium clavatum, Plumbum metallicum, Petroleum, Taraxacum officinale LIQUID ORAL 20140321 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETALDEHYDE; AMMONIA; CARBON MONOXIDE; CHLOROFORM; FORMALDEHYDE; GOLDENSEAL; GLYCYRRHIZA GLABRA; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; LEAD; KEROSENE; TARAXACUM OFFICINALE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2409_4d4f24f6-ffb4-44de-bc20-a3bf2704fec3 57955-2409 HUMAN OTC DRUG Aller-Detox Caffeine Adrenalinum, Caffeinum, Chamomilla, Coffea cruda, Coffea tosta, Ephedra vulgaris, Ferrum metallicum, Ilex paraguariensis, Kali phosphoricum, Kali phosphoricum, Paullinia sorbilis, Saccharum officinale, Sterculia acuminata, Sulphuricum acidum, Thea sinensis LIQUID ORAL 20140321 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; CAFFEINE; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; COFFEA ARABICA SEED, ROASTED; EPHEDRA DISTACHYA FLOWERING TWIG; IRON; ILEX PARAGUARIENSIS LEAF; POTASSIUM PHOSPHATE, DIBASIC; PAULLINIA CUPANA SEED; SUCROSE; COLA ACUMINATA SEED; SULFURIC ACID; GREEN TEA LEAF 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2501_3fa01ef0-b42d-40fb-bd7b-93460fb36841 57955-2501 HUMAN OTC DRUG Allergies Fruits and Vegetables Aluminium metallicum, Arsenicum album, Bryonia, Colocynthis, Helleborus niger, Histaminum hydrochloricum, Hydrastis canadensis, Lachesis mutus, Lycopodium clavatum, Magnesia carbonica, Petroleum, Pulsatilla LIQUID ORAL 20150810 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; HELLEBORUS NIGER ROOT; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; KEROSENE; PULSATILLA VULGARIS 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2502_c01646e2-9252-4cc2-b8ae-aad9cfa44fd6 57955-2502 HUMAN OTC DRUG Allergies Nightshades Aluminium metallicum, Arsenicum album, Belladonna, Histaminum hydrochloricum, Hydrastis canadensis, Mandragora officinarum, Nux vomica, Phosphorus, Pulsatilla, Solaninum, Solanum nigrum LIQUID ORAL 20160329 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM; ARSENIC TRIOXIDE; ATROPA BELLADONNA; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; MANDRAGORA OFFICINARUM ROOT; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SOLANINE; SOLANUM NIGRUM WHOLE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL; [hp_X]/12mL N 20181231 57955-2511_92cec070-b2e1-4c75-ac1e-3e89c206003c 57955-2511 HUMAN OTC DRUG Egotistical Ferrum metallicum, Gratiola officinalis, Hamamelis virginiana, Helianthus annuus, Hottonia palustris, flos, Lachesis mutus, Lilium tigrinum, Lycopodium clavatum, Moschus, Palladium metallicum, Platinum metallicum, Staphysagria, Sulphur, Rhus toxicodendron, Veratrum album, Viola odorata LIQUID ORAL 20131024 UNAPPROVED HOMEOPATHIC King Bio Inc. IRON; GRATIOLA OFFICINALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HELIANTHUS ANNUUS FLOWERING TOP; HOTTONIA PALUSTRIS FLOWER; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; PALLADIUM; PLATINUM; DELPHINIUM STAPHISAGRIA SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; VERATRUM ALBUM ROOT; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2518_7758523b-5bc5-4369-b83f-13ec4412a320 57955-2518 HUMAN OTC DRUG Childrens Appetite and Weight Control Adrenocorticotrophin, Adrenalinum, Anacardium orientale, Antimonium crudum, Calcarea carbonica, Cortisone aceticum, Fucus vesiculosus, Hypothalamus, Kali bichromicum, Oleander, Pituitarum posterium, sabadilla, Staphysagria, Thyroidinum LIQUID ORAL 20150831 UNAPPROVED HOMEOPATHIC King Bio Inc. CORTICOTROPIN; EPINEPHRINE; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CORTISONE ACETATE; FUCUS VESICULOSUS; BOS TAURUS HYPOTHALAMUS; POTASSIUM DICHROMATE; NERIUM OLEANDER LEAF; SUS SCROFA PITUITARY GLAND; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; 1/59mL; [hp_X]/59mL N 20181231 57955-2522_0e4eefef-7843-4e41-8418-a4c23f5ac184 57955-2522 HUMAN OTC DRUG Envious Apis mellifica, Arsenicum album, Berberis aquifolium, Bryonia, Calendula officinalis, Hottonia palustris, flos, Hyoscyamus niger, Ilex aquifolium, flos, Ipecacuanha, Kali carbonicum, Lilium tigrinum, Minulus guttatus, flos, Oleum santali, Prunus cerasifera, flos, Pulsatilla, Sulphur, Viola odorata LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; MAHONIA AQUIFOLIUM ROOT BARK; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; HOTTONIA PALUSTRIS FLOWER; HYOSCYAMUS NIGER; ILEX AQUIFOLIUM FLOWERING TOP; IPECAC; POTASSIUM CARBONATE; LILIUM LANCIFOLIUM WHOLE FLOWERING; MIMULUS GUTTATUS FLOWERING TOP; SANDALWOOD OIL; PRUNUS CERASIFERA FLOWER; PULSATILLA VULGARIS; SULFUR; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2531_9e6b0af0-a17f-459a-9110-4050877d2af4 57955-2531 HUMAN OTC DRUG Self Pity Aesculus hippocastanum, flos, Aloe socotrina, Arnica montana, Arsenicum album, Borago officinalis, Calcarea carbonica, Carpinus betulus, flos, Chamomilla, Gelsemium sempervirens, Graphites, Ipecacuanha, Kali sulphuricum, Mentha piperita, Nitricum acidum, Olea europaea, flos, Onosmodium virginianum, Palladium metallicum, Pulsatilla, Sepia, Tropaeolum majus, Ulmus procera, flos, Viola tricolor LIQUID ORAL 20131030 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; ALOE; ARNICA MONTANA; ARSENIC TRIOXIDE; BORAGE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARPINUS BETULUS FLOWERING TOP; MATRICARIA RECUTITA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; IPECAC; POTASSIUM SULFATE; MENTHA PIPERITA; NITRIC ACID; OLEA EUROPAEA FLOWER; ONOSMODIUM VIRGINIANUM WHOLE; PALLADIUM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; TROPAEOLUM MAJUS; ULMUS PROCERA FLOWERING TWIG; VIOLA TRICOLOR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2532_1c6f3151-1870-486f-bc7e-7a70e5a25292 57955-2532 HUMAN OTC DRUG Self Pity Aesculus hippocastanum, flos, Aloe socotrina, Arnica, montana, Arsenicum album, Borago officinalis, calcarea carbonica, Carpinus betulus, flos, Chamomilla, Gelsemium sempervirens, Graphites, Ipecauanha, Kali sulphuricum, Mentha piperita, Nitricum acidum, Olea europaea, flos, Oleander, Onosmodium virginianum, Palladium metallicum, Pulsatilla, Sepia, Tropaeolum majus, Ulmus procera, flos, Viola tricolor LIQUID ORAL 20150804 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; ALOE; ARNICA MONTANA; ARSENIC TRIOXIDE; BORAGE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARPINUS BETULUS FLOWERING TOP; MATRICARIA RECUTITA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; IPECAC; POTASSIUM SULFATE; MENTHA PIPERITA; NITRIC ACID; OLEA EUROPAEA FLOWER; NERIUM OLEANDER LEAF; ONOSMODIUM VIRGINIANUM WHOLE; PALLADIUM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; TROPAEOLUM MAJUS; ULMUS PROCERA FLOWERING TWIG; VIOLA TRICOLOR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2541_f01056f3-5535-420d-a2cb-5e7c96823eca 57955-2541 HUMAN OTC DRUG Religious Issues Ceratostigma willmottianum, flos, Chamomilla, Chelidonium majus, Graphites, Ilex aquifolium, flos, Kali bromatum, Lachesis mutus, Malus pumila, flos, Millefolium, Pinus sylvestris, flos, Psorinum, Stramonium, Sulphur, Veratrum album LIQUID ORAL 20150810 UNAPPROVED HOMEOPATHIC King Bio Inc. CERATOSTIGMA WILLMOTTIANUM FLOWER; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; GRAPHITE; ILEX AQUIFOLIUM FLOWERING TOP; POTASSIUM BROMIDE; LACHESIS MUTA VENOM; MALUS DOMESTICA FLOWER; ACHILLEA MILLEFOLIUM; PINUS SYLVESTRIS FLOWERING TOP; SCABIES LESION LYSATE (HUMAN); DATURA STRAMONIUM; SULFUR; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2551_38ec2bcf-96f3-4fba-b792-991225455bb9 57955-2551 HUMAN OTC DRUG Neglectful Bromus ramosus, flos, Capsicum annuum, Carpinus betulus, flos, Carpinus betulus, flos, Geranium maculatum, Helleborus niger, Juglans regia, flos, Mentha piperita, Natrum muriaticum, Nux vomica, Phytolacca decandra, Psorinum, Scleranthus annuus, flos, Silicea, Staphysagria, Sulphur LIQUID ORAL 20161209 UNAPPROVED HOMEOPATHIC King Bio Inc. BROMUS RAMOSUS FLOWER; CAPSICUM; CARPINUS BETULUS FLOWERING TOP; CYTISUS SCOPARIUS FLOWERING TOP; GERANIUM MACULATUM ROOT; HELLEBORUS NIGER ROOT; JUGLANS REGIA FLOWERING TOP; MENTHA PIPERITA; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; SCABIES LESION LYSATE (HUMAN); SCLERANTHUS ANNUUS FLOWERING TOP; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2561_7c0a1433-eb95-46d3-af9b-df1466b8e502 57955-2561 HUMAN OTC DRUG Insecurity Aesculus hippocastanum, flos, Antimonium crudum, Argentum nitricum, Baryta aceticua, Baryta carbonica, Borago officinalis, Cytisus scoparius, Digitalis purpurea, Graphites, Kali iodatum, Larix decidua, flos, Lycopodium clavatum, Petroleum, Sambucus nigra, Verbascum thapsus LIQUID ORAL 20140109 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; ANTIMONY TRISULFIDE; SILVER NITRATE; BARIUM ACETATE; BARIUM CARBONATE; BORAGE; CYTISUS SCOPARIUS FLOWERING TOP; DIGITALIS; GRAPHITE; POTASSIUM IODIDE; LARIX DECIDUA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; KEROSENE; SAMBUCUS NIGRA FLOWERING TOP; VERBASCUM THAPSUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2640_e2a37079-5a83-4664-8a1e-39355580729b 57955-2640 HUMAN OTC DRUG Sleep Aid Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis LIQUID ORAL 20121106 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AESCULUS HIPPOCASTANUM FLOWER; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; ATROPA BELLADONNA; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; VALERIAN 59; 59; 59; 59; 59; 59; 59; 59; 59; 59; 59; 59; 59; 59 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2701_877b4530-c2e3-4132-8927-b5763c27eccd 57955-2701 HUMAN OTC DRUG Allergies Southern US Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Nasturtium aquaticum, Natrum Muriaticum, Rhus toxicodendron, RNA, Sabadilla, Sassafras officinale RNA, LIQUID ORAL 20150224 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; ALNUS SERRULATA BARK; CENTAUREA BENEDICTA; CHICORY ROOT; CORTISONE ACETATE; MUCUNA PRURIENS FRUIT TRICHOME; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; NASTURTIUM OFFICINALE; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SASSAFRAS ALBIDUM ROOT BARK 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2703_0a8cc3b2-c14e-4a17-85bc-9102dee8c992 57955-2703 HUMAN OTC DRUG Allergies Rocky MTNS. U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, Agrostemma githago, Ailanthus glandulosus, Allium cepa, Cortisone aceticum, Cynodon dactylon, Equisetum hyemale, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucasa nasalis suis, Natrum muriaticum, Platanus, Populus candicans, RNA, Sabadilla, Solidago virgaurea LIQUID ORAL 20140701 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; AGRIMONIA EUPATORIA; AGROSTEMMA GITHAGO SEED; AILANTHUS ALTISSIMA FLOWERING TWIG; ONION; CORTISONE ACETATE; CYNODON DACTYLON; EQUISETUM HYEMALE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PLATANUS OCCIDENTALIS WHOLE; POPULUS BALSAMIFERA LEAF BUD; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2704_d12bb720-e216-41b7-95e8-5c97a40bd918 57955-2704 HUMAN OTC DRUG Allergies Desert U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Alfalfa, Allium cepa, Ambrosia artemisiaefolia, Cortisone aceticum, Erechtites hieracifolia, Erigeron canadensis, Euonymus atropurpureus, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Sabadilla, Stramonium, Triticum repens LIQUID ORAL 20150810 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ALFALFA; ONION; AMBROSIA ARTEMISIIFOLIA; CORTISONE ACETATE; ERECHTITES HIERACIIFOLIUS; CONYZA CANADENSIS; EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; DATURA STRAMONIUM; ELYMUS REPENS ROOT 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2705_92c55f56-1687-4adf-bc2e-4f8978f4d4dd 57955-2705 HUMAN OTC DRUG Allergies Southwest U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Asarum canadense, Cortisone aceticum, Eupatorium aromaticum, Euphrasia officinalis, Fraxinus americana, Galphimia glauca, Helianthus annuus, Histaminum hydrochloricum, juniperus virginiana, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Plantago major, RNA, Rumex crispus, Sabadilla, Senecio jacobaea LIQUID ORAL 20140513 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; ASARUM CANADENSE ROOT; CORTISONE ACETATE; AGERATINA AROMATICA ROOT; EUPHRASIA STRICTA; FRAXINUS AMERICANA BARK; GALPHIMIA GLAUCA FLOWERING TOP; HELIANTHUS ANNUUS FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PLANTAGO MAJOR; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; JACOBAEA VULGARIS 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2707_9c22c3e6-903f-46b9-834d-9f1e4a9ca518 57955-2707 HUMAN OTC DRUG Allergies Northeast U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, agraphis nutans, Allium cepa, Collinsonia canadensis, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Salvia officinalis, Tanacetum vulgare Trifolium pratense, Vinca minor LIQUID ORAL 20140701 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; HYACINTHOIDES NON-SCRIPTA; ONION; COLLINSONIA CANADENSIS ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; SAGE; TANACETUM VULGARE TOP; TRIFOLIUM PRATENSE FLOWER; VINCA MINOR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2708_eb9afce7-53e9-402e-a2fe-37f12c25f1ca 57955-2708 HUMAN OTC DRUG Allergies Great Lakes U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolia, Chelidonium majus, Chenopodium vulvaria, Cichorium intybus, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, hedera helix, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Pulsatilla nuttalliana, RNa, Sabadilla, Teucrium scorodonia LIQUID ORAL 20140620 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; AMBROSIA ARTEMISIIFOLIA; CHELIDONIUM MAJUS; CHENOPODIUM VULVARIA; CHICORY ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; ANEMONE PATENS; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; TEUCRIUM SCORODONIA FLOWERING TOP 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2709_56915fec-deff-44e6-bfd8-8878e9c06dad 57955-2709 HUMAN OTC DRUG Allergies Pacific U.S. Adenosinum cyclophosphoricum, Adrenalinum,Adrenocorticotrophin, Alfalfa, Allium cepa, Bellis perennis, Conium maculatum, Cortisone aceticum, Equisetum hyemale, Euphrasia officinalism, Fagopyrum esculentum, Galphimia glauca, Histaminum, hydrochloricum, Kali muriaticum, Millefolium, Mucosa nasalis suis, Natrum muriaticum, Prunus spinosa, RNA, Sabadilla Solidago virgaurea LIQUID ORAL 20150810 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ALFALFA; ONION; BELLIS PERENNIS; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EQUISETUM HYEMALE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; ACHILLEA MILLEFOLIUM; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PRUNUS SPINOSA FLOWER BUD; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2710_d8767468-e50a-4979-b1cd-2b4cfea8f15c 57955-2710 HUMAN OTC DRUG Allergies Plains U.S. Absinthium, Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiifolia, Caulophyllum thalictroides, Conium maculatum, Cortisone aceticum, Euphrasia officinalis, Fagopyrum esculentum, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, melilotus, Mucosa nasalis suis, Natrum muriaticum, RNA, rumex crispus, Sabadilla, Secale cornutum LIQUID ORAL 20150710 UNAPPROVED HOMEOPATHIC King Bio Inc. WORMWOOD; ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; AMBROSIA ARTEMISIIFOLIA; CAULOPHYLLUM THALICTROIDES ROOT; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; MELILOTUS OFFICINALIS TOP; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; CLAVICEPS PURPUREA SCLEROTIUM 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2750_b369b832-70eb-4f6d-a938-d01a0094e71e 57955-2750 HUMAN PRESCRIPTION DRUG Shy Aesculus carnea, flos, allium sativum, Ambra grisea, Baryta carbonica, Ceratostigma willmottianum, flos, Conium maculatum, Graphites, Helianthus annuus, Juglans regia, flos, Kali phosphoricum, Larix decidua, flos, Mancinella, Pulsatilla, Viola odorata, Xanthoxylum fraxineum LIQUID ORAL 20130528 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS CARNEA FLOWER; GARLIC; AMBERGRIS; BARIUM CARBONATE; CERATOSTIGMA WILLMOTTIANUM FLOWER; CONIUM MACULATUM FLOWERING TOP; GRAPHITE; HELIANTHUS ANNUUS FLOWERING TOP; JUGLANS REGIA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; LARIX DECIDUA FLOWERING TOP; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; PULSATILLA VULGARIS; VIOLA ODORATA; ZANTHOXYLUM AMERICANUM BARK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 57955-2760_b224558b-b1a2-4a13-b537-2306c36b4d0e 57955-2760 HUMAN OTC DRUG Procrastination Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Angelica archangelica, Capsicum annuum, Carpinus betulus, flos, Chamomilla, Clematis vitalba, flos, Cocculus indicus, Glonoinum, Hoang-nan, Juglans regia, flos, Larix decidua, flos, Lonicera caprifolium, flos, Mimulus guttatus, flos, Nux vomica, Olea europaea, flos, Oxytropis lambertii, Picricum acidum, Rhus toxicodendron, Scleranthus annuus, flos, Secale cornatum, Stellaria media, Sulphuricum acidum LIQUID ORAL 20130615 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; ANGELICA ARCHANGELICA ROOT; CAPSICUM; CARPINUS BETULUS FLOWERING TOP; MATRICARIA RECUTITA; CLEMATIS VITALBA FLOWER; ANAMIRTA COCCULUS SEED; NITROGLYCERIN; STRYCHNOS WALLICHIANA BARK; JUGLANS REGIA FLOWERING TOP; LARIX DECIDUA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; MIMULUS GUTTATUS FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; OLEA EUROPAEA FLOWER; OXYTROPIS LAMBERTII TOP; PICRIC ACID; TOXICODENDRON PUBESCENS LEAF; SCLERANTHUS ANNUUS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; STELLARIA MEDIA; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2770_17cdce45-b956-40df-9827-b9bf99bcad7b 57955-2770 HUMAN OTC DRUG Indecision Chamomilla, Clematis vitalba, flos, Croton tiglium, Curare, Dulcamara, Graphites, Ignatia amara, Iodium, Lathyrus sativus, Lonicera caprifolium, flos, Millefolium, Muriaticum acidum, Rosa damascena, Saccharum officinale, Silicea, Stigmata maidis LIQUID ORAL 20130808 UNAPPROVED HOMEOPATHIC King Bio Inc. MATRICARIA RECUTITA; CLEMATIS VITALBA FLOWER; CROTON TIGLIUM SEED; TUBOCURARINE CHLORIDE; SOLANUM DULCAMARA TOP; GRAPHITE; STRYCHNOS IGNATII SEED; IODINE; LATHYRUS SATIVAS SEED; LONICERA CAPRIFOLIUM FLOWERING TOP; ACHILLEA MILLEFOLIUM; HYDROCHLORIC ACID; ROSA DAMASCENA FLOWERING TOP; SUCROSE; SILICON DIOXIDE; CORN SILK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2771_ea233f8c-8718-4f6a-9dd0-b54ca103a49e 57955-2771 HUMAN OTC DRUG Indecision Chamomilla, Clematis vitalba, flos, Croton tiglium, Curare, Dulcamara, Graphites, Ignatia amara, Iodium, Lathyrus sativus, Lonicera caprifolium, flos, Millefolium, Muriaticum acidum, Rosa damascena, Saccharum officinale, Silicea, Stigmata maidis LIQUID ORAL 20140604 UNAPPROVED HOMEOPATHIC King Bio Inc. MATRICARIA RECUTITA; CLEMATIS VITALBA FLOWER; CROTON TIGLIUM SEED; TUBOCURARINE CHLORIDE; SOLANUM DULCAMARA TOP; GRAPHITE; STRYCHNOS IGNATII SEED; IODINE; LATHYRUS SATIVAS SEED; LONICERA CAPRIFOLIUM FLOWERING TOP; ACHILLEA MILLEFOLIUM; HYDROCHLORIC ACID; ROSA DAMASCENA FLOWERING TOP; SUCROSE; SILICON DIOXIDE; CORN SILK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2781_4a1afb8b-312c-479a-b818-402dcc7bec54 57955-2781 HUMAN OTC DRUG Nostalgia Aurum metallicum, Berberis aquifolium, Calcarea carbonica, Capsicum annuum, Carbo animalis, Eupatorium purpureum, Geranium maculatum, Helleborus niger, Juglans regia, flos, Lobelia cardinalis, Lonicera caprifolium, flos, Mancinella, Melilotus officinalis, Mercurius vivus, Millefolium, Pulsatilla, Rhus toxicodendron, Silicea, Stigmata maidis, Viola odorata LIQUID ORAL 20140606 UNAPPROVED HOMEOPATHIC King Bio Inc. GOLD; MAHONIA AQUIFOLIUM ROOT BARK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CARBO ANIMALIS; EUTROCHIUM PURPUREUM ROOT; GERANIUM MACULATUM ROOT; HELLEBORUS NIGER ROOT; JUGLANS REGIA FLOWERING TOP; LOBELIA CARDINALIS; LONICERA CAPRIFOLIUM FLOWERING TOP; HIPPOMANE MANCINELLA FRUITING LEAFY TWIG; MELILOTUS OFFICINALIS TOP; MERCURY; ACHILLEA MILLEFOLIUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; CORN SILK; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2790_36387f85-3bfb-4bea-9c89-5dbac3d4c003 57955-2790 HUMAN OTC DRUG Aversion to Exertion Adrenalinum, Agaricus muscarius, Aloe socotrina, Bovista, Calcarea carbonica, Carpinus betulus, flos, Chelidonium majus, Cocculus indicus, Helonias dioica, Hydrofluoricum acidum, Kali phosphoricum, Mimosa pudica, Rosmarinus officinalis, Sulphur, Tanacetum vulgare, Taraxacum officinale, Tropaeolum majus LIQUID ORAL 20130615 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; AMANITA MUSCARIA FRUITING BODY; ALOE; LYCOPERDON UTRIFORME FRUITING BODY; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARPINUS BETULUS FLOWERING TOP; CHELIDONIUM MAJUS; ANAMIRTA COCCULUS SEED; CHAMAELIRIUM LUTEUM ROOT; HYDROFLUORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; MIMOSA PUDICA LEAF; ROSMARINUS OFFICINALIS FLOWERING TOP; SULFUR; TANACETUM VULGARE TOP; TARAXACUM OFFICINALE; TROPAEOLUM MAJUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-2800_59a185b4-d9b0-4c75-a83a-4ced0c6a8232 57955-2800 HUMAN OTC DRUG Aversion To Change Berberis aquifolium, Bryonia, Carbo vegetabilis, Guaiacum, Juglans regia, flos, Kali bichromicum, Lonicera caprifolium, flos, Mezereum, Natrum muriaticum, Phosphoricum acidum, Silicea, Spongia tosta, Thuja occidentalis, Viola odorata LIQUID ORAL 20161115 UNAPPROVED HOMEOPATHIC King Bio Inc. MAHONIA AQUIFOLIUM ROOT BARK; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; GUAIACUM OFFICINALE RESIN; JUGLANS REGIA FLOWERING TOP; POTASSIUM DICHROMATE; LONICERA CAPRIFOLIUM FLOWERING TOP; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; PHOSPHORIC ACID; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; THUJA OCCIDENTALIS LEAFY TWIG; VIOLA ODORATA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-3020_6a5825c4-b6f7-4641-987a-581c23a168a1 57955-3020 HUMAN OTC DRUG Alcoholism Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Apocynum cannabinum, Arsenicum album, Asarum europaeum, Avena sativa, Capsicum annuum, Carboneum sulphuratum, Gelsumium sempervirens, Helianthus annuus, Juglans regia, flos, Lonicera caprifolium, flos, Naja tripudians, Paullinia sorbilis. LIQUID ORAL 20130626 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; APOCYNUM CANNABINUM ROOT; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; AVENA SATIVA FLOWERING TOP; CAPSICUM; CARBON DISULFIDE; GELSEMIUM SEMPERVIRENS ROOT; HELIANTHUS ANNUUS FLOWERING TOP; JUGLANS REGIA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; NAJA NAJA VENOM; PAULLINIA CUPANA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-3021_d653a799-e136-4865-b20b-bd76d5c46149 57955-3021 HUMAN OTC DRUG Alcoholism Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Apocynum cannabinum, Arsenicum album, Asarum europaeum, Avena sativa, Capsicum annuum, Carboneum sulphuratum, Gelsemium sempervirens, Helianthus annuus, Juglans regia, flos, Lonicera caprifolium, flos, Naja tripudians, Paullinia sorbilis LIQUID ORAL 20131125 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; APOCYNUM CANNABINUM ROOT; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; AVENA SATIVA FLOWERING TOP; CAPSICUM; CARBON DISULFIDE; GELSEMIUM SEMPERVIRENS ROOT; HELIANTHUS ANNUUS FLOWERING TOP; JUGLANS REGIA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; NAJA NAJA VENOM; PAULLINIA CUPANA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-3031_7ba14714-0d52-4604-a15d-285c30a30381 57955-3031 HUMAN OTC DRUG Smoke Control Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Caladium seguinum, Capsicum annuum, Daphne indica, Eugenia jambosa, Helianthus annuus, Juglans regia, flos, Kali phosphoricum, Lobelia inflata, Lonicera caprifolium, flos, Nicotinum, Nux vomica, Plantago major, Saccharum officinale, Staphysagria, Tabacum LIQUID ORAL 20140521 UNAPPROVED HOMEOPATHIC King Bio Inc. AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; DIEFFENBACHIA SEGUINE; CAPSICUM; DAPHNE ODORA BARK; SYZYGIUM JAMBOS SEED; HELIANTHUS ANNUUS FLOWERING TOP; JUGLANS REGIA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; LOBELIA INFLATA; LONICERA CAPRIFOLIUM FLOWERING TOP; NICOTINE; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; SUCROSE; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-3200_b9a42ac7-7dff-490c-9b5b-aadd3e7ca798 57955-3200 HUMAN OTC DRUG Flu Relief Anas barbariae hepatis et cordis extractum PELLET ORAL 20151029 UNAPPROVED HOMEOPATHIC King Bio Inc. CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/g N 20181231 57955-3203_0331c2cb-653c-4f34-a920-17112774a637 57955-3203 HUMAN OTC DRUG Arnica Gel Arnica montana GEL TOPICAL 20160307 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA 1 [hp_X]/73g N 20181231 57955-3320_19186842-adea-4b26-bb96-48f65617c049 57955-3320 HUMAN OTC DRUG Probiotic Restoration Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colcynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltatum, Sepia, Silicea LIQUID ORAL 20131001 UNAPPROVED HOMEOPATHIC King Bio Inc. AETHUSA CYNAPIUM; GARLIC; BAPTISIA TINCTORIA ROOT; CAPSICUM; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; MARSDENIA CONDURANGO BARK; GAMBOGE; GRATIOLA OFFICINALIS; COW MILK; LACTIC ACID, DL-; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-3400_e7834a88-6414-490d-be31-5543c2277628 57955-3400 HUMAN OTC DRUG Aller Detox Water Chemicals Alumina, Alumina silicata, Baryta carbonica, Bromium, Calcarea phosphorica, Chimaphila umbellata, Chlorinum, Ferrum phosphoricum, Hydrofluoricum acidum, Lemna minor, Nitricum acidum, Plumbum metallicum, Strychninum, Symphytum officinale LIQUID ORAL 20150818 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; KAOLIN; BARIUM CARBONATE; BROMINE; TRIBASIC CALCIUM PHOSPHATE; CHIMAPHILA UMBELLATA; CHLORINE; FERROSOFERRIC PHOSPHATE; HYDROFLUORIC ACID; LEMNA MINOR; NITRIC ACID; LEAD; STRYCHNINE; COMFREY ROOT 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-4000_18d7a8c6-5e51-4510-a7fd-8be1e50d5a0a 57955-4000 HUMAN OTC DRUG Soothing Advanced Arnica Arnica montana, Arnica montana, radix CREAM TOPICAL 20120718 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; ARNICA MONTANA ROOT 6; 6 [hp_X]/85g; [hp_X]/85g N 20181231 57955-4001_eaad90db-0f86-4480-a667-5620fe52d38e 57955-4001 HUMAN OTC DRUG Cooling Acute Pain Relief Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Zincum metallicum CREAM TOPICAL 20120718 UNAPPROVED HOMEOPATHIC King Bio Inc. HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g N 20181231 57955-4020_bfc666ea-c9f7-472e-8aee-0c79615e7871 57955-4020 HUMAN OTC DRUG Irritable BowelCare Aloe socotrina, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Croton tiglium, Gelsemium sempervirens, Gratiola officinalis, Nux vomica,Phosphoricum acidum, Podophyllum peltatum and Veratrum album LIQUID ORAL 20110213 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; GELSEMIUM SEMPERVIRENS ROOT; GRATIOLA OFFICINALIS; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; mL/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-4022_0da2e08d-c16f-46cc-9540-04f66efb1747 57955-4022 HUMAN OTC DRUG HeartburnCare Abies nigra, Condurango, Conium maculatum, Iris versicolor, Magnesia carbonica, Robinia pseudoacacia LIQUID ORAL 20120213 UNAPPROVED HOMEOPATHIC King Bio Inc. PICEA MARIANA RESIN; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; IRIS VERSICOLOR ROOT; MAGNESIUM CARBONATE; ROBINIA PSEUDOACACIA BARK 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-4043_7a14315d-f8ef-429f-ad05-321d0cf9726e 57955-4043 HUMAN OTC DRUG AllergyCare llium cepa, Ambrosia artemisiaefolia, Arum triphyllum, Arundo mauritanica, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Natrum muriaticum, RNA, Sabadilla and Wyethia helenioides LIQUID ORAL 20120511 UNAPPROVED HOMEOPATHIC King Bio Inc. ONION; AMBROSIA ARTEMISIIFOLIA; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; WYETHIA HELENIOIDES ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-4044_700e7133-57d9-448d-acea-69b016f368cd 57955-4044 HUMAN OTC DRUG AsthmaCare Safecare LIQUID ORAL 20120214 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; EPINEPHRINE; AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; BROMINE; CHLORINE; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; GRINDELIA HIRSUTULA FLOWERING TOP; LOBELIA INFLATA; SODIUM SULFATE; PHOSPHORUS; QUEBRACHO BARK; TRIFOLIUM PRATENSE FLOWER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; mL/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-4053_82250b3d-34b4-4eb1-b2d2-fa88a99926a7 57955-4053 HUMAN OTC DRUG RespiratoryCare Ammonium carbonicum, Antimonium tartaricum, Carbo vegetabilis, Chlorinum, Kali carbonicum, Lobelia inflata, Phosphorus, Silicea, and Stannum metallicum LIQUID ORAL 20120301 UNAPPROVED HOMEOPATHIC King Bio Inc AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; ACTIVATED CHARCOAL; CHLORINE; POTASSIUM CARBONATE; LOBELIA INFLATA; PHOSPHORUS; SILICON DIOXIDE; TIN 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-4127_bfcf00dd-1217-4c04-8e12-4222bd1665f8 57955-4127 HUMAN OTC DRUG Grain and wheat Adrenalinum, Bryonia alba, Lycopodium clavatum, Natrum muriaticum, Pulsatilla nigricans, Histaminum hydrochloricum, Avena sativa, Glycine max, Hordeum vulgare, Secale cereale, Triticum aestivum, Zea mays LIQUID ORAL 20100813 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; BRYONIA ALBA ROOT; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PULSATILLA PRATENSIS; HISTAMINE DIHYDROCHLORIDE; AVENA SATIVA POLLEN; SOYBEAN; HORDEUM VULGARE POLLEN; SECALE CEREALE POLLEN; TRITICUM AESTIVUM POLLEN; ZEA MAYS POLLEN 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 57955-4199_1f518348-ce1f-4e65-bc53-2bbcd7730ee9 57955-4199 HUMAN OTC DRUG Multi-Strain FluCare Anas barbariae, hepatis et cordis extractum, Baptisia tinctoria, Bryonia, Cinchona officinalis, Dulcamara, Echinacea purpurea, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Influenzinum, Phytolacca decandra, Rhus toxicodendron, Sarcolacticum acidum, Sulphur, Wyethia helenioides, Zincum aceticum, Zincum muriaticum, Zincum oxydatum LIQUID ORAL 20120327 UNAPPROVED HOMEOPATHIC King Bio Inc. CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; WYETHIA HELENIOIDES ROOT; ZINC ACETATE ANHYDROUS; ZINC CHLORIDE; ZINC OXIDE 35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-4728_86bf8b39-4817-42ca-854b-53f9674c6829 57955-4728 HUMAN OTC DRUG Migraine Relief Gelsemium sempervirens, Iris versicolor, Kali carbonicum, Niccolum metallicum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia and Sulphur LIQUID ORAL 20130111 UNAPPROVED HOMEOPATHIC King Bio Inc. GELSEMIUM SEMPERVIRENS ROOT; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; NICKEL; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA; SULFUR 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5002_aeddfde6-372e-45aa-b02e-5f5e750a29c6 57955-5002 HUMAN OTC DRUG Birth Ease Aletris farinosa, Apis mellifica, Arnica montana, Belladonna, Caulophyllum thalictroides, Chamomilla, Cimicifuga racemosa, Ferrum metallicum, Kali carbonicum, Sabina, Secale cornutum, Viburnum opulus LIQUID ORAL 20111028 UNAPPROVED HOMEOPATHIC King Bio, Inc. ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5003_0acc7098-1632-40a8-8744-2c8751ed18ef 57955-5003 HUMAN OTC DRUG Breast Inflammations and Discomforts Aconitum napellus, Bellis perennis, Bromium, Bryonia, Chamomilla, Conium maculatum, Iodium, Phellandrium aquaticum, Phytolacca decandra, Scrophularia nodosa and Silicea LIQUID ORAL 20120719 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BELLIS PERENNIS; BROMINE; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CONIUM MACULATUM FLOWERING TOP; IODINE; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE; OENANTHE AQUATICA FRUIT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5005_75ae42de-8d9e-4916-8539-e8770ed44da3 57955-5005 HUMAN OTC DRUG FertiPlex Agnus castus, Apis Mellifica, Aurum Metallicum, Borax, Conium maculatum, Ferrum metallicum, Iodium, Lilium tigrinum, Lycopodium clavatum, Natrum muriaticum, Palladium Metallicum and Sepia LIQUID ORAL 20110826 UNAPPROVED HOMEOPATHIC King Bio Inc. CHASTE TREE; APIS MELLIFERA; GOLD; SODIUM BORATE; CONIUM MACULATUM FLOWERING TOP; IRON; IODINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PALLADIUM; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5007_52eb9753-3a92-4b1b-918d-821543970228 57955-5007 HUMAN OTC DRUG Female Discomforts Apis mellifica, Belladonna, Borax, Bryonia, Calcarea phosphorica, Cantharis, Hydrastis canadensis, Kali bichromicum, Lac caninum, Pulsatilla, Sepia, Thuja occidentalis LIQUID ORAL 20160624 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; ATROPA BELLADONNA; SODIUM BORATE; BRYONIA ALBA ROOT; TRIBASIC CALCIUM PHOSPHATE; LYTTA VESICATORIA; GOLDENSEAL; POTASSIUM DICHROMATE; CANIS LUPUS FAMILIARIS MILK; PULSATILLA PRATENSIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5009_c54a5587-f6f9-4033-b84f-8f59e95e149f 57955-5009 HUMAN OTC DRUG PMS Relief Apis mellifica, Chamomilla, Cimicifuga racemosa, Cyclamen europaeum, Helonias dioica, Ignatia amara, Lac caninum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Platinum metallicum, and Sepia LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; MATRICARIA RECUTITA; BLACK COHOSH; CYCLAMEN PURPURASCENS TUBER; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; CANIS LUPUS FAMILIARIS MILK; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PLATINUM; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5015_55046600-ff63-4c80-9426-e8cc40df5d9e 57955-5015 HUMAN OTC DRUG Attention and Learning Enhancement Baryta carbonica, Calcarea carbonica, Ignatia amara, Lycopodium clavatum, Magnesia carbonica, Natrum carbonicum, Natrum muriaticum and Thuja occidentalis LIQUID ORAL 20111031 UNAPPROVED HOMEOPATHIC King Bio Inc. BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5016_1346f078-299d-473c-9297-83bd24e22e32 57955-5016 HUMAN OTC DRUG Paralixer Calcarea carbonica, Chenopodium anthelminticum, Cina, Croton tiglium, Filix mas, Gambogia, Granatum, Lycopodium clavatum, Mercurius corrosivus, Natrum phosphoricum, Santoninum, Senna, Spigelia anthelmia, Stannum metallicum, Tanacetum vulgare, Teucrium marum and Zingiber officinale LIQUID ORAL 20110913 UNAPPROVED HOMEOPATHIC King Bio Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; GAMBOGE; PUNICA GRANATUM ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SANTONIN; SENNA LEAF; SPIGELIA ANTHELMIA; TIN; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5017_0d893f5f-f8e9-4977-91a6-ba89c002a3db 57955-5017 HUMAN OTC DRUG TonsilPlex Ammonium muriaticum, Baryta carbonica, Belladonna, Calcarea phosphorica, Ferrum phosphoricum, Guaiacum, Kali muriaticum, Lycopodium clavatum, Mercurius solubilis, Phytolacca decandra, Silicea LIQUID ORAL 20151029 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CHLORIDE; BARIUM CARBONATE; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; GUAIACUM OFFICINALE RESIN; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5018_47c56048-eb60-44eb-b462-f26055a8bbde 57955-5018 HUMAN OTC DRUG Teething Agaricus muscarius, Belladonna, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Kreosotum and Zincum metallicum LIQUID ORAL 20120103 UNAPPROVED HOMEOPATHIC King Bio Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; WOOD CREOSOTE; ZINC 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5019_dd110d56-03ef-4cb7-bc6e-cf462173af76 57955-5019 HUMAN OTC DRUG Constipation Relief Alumina, Bellis perennis, Causticum, Collinsonia canadensis, Hydrastis canadensis, Lac defloratum, Natrum muriaticum, Nux vomica, Plumbum metallicum, Sepia LIQUID ORAL 20131004 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5020_4e9e7593-648a-4599-be31-383695d45715 57955-5020 HUMAN OTC DRUG Diarrhea Relief Aloe socotrina, Chamomilla, Cinchona officinalis, Colocynthis, Croton tiglium, Cuprum arsenicosum, Gelsemium sempervirens, Ipecacuanha, Nux vomica, Phosphoricum acidum, Podophyllum peltatum, Veratrum album LIQUID ORAL 20160317 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5022_fa7e1e0f-8bd8-407e-8e89-e357ab70d29b 57955-5022 HUMAN OTC DRUG Heartburn Relief Abies nigra, Arsenicum album, Condurango, Conium maculatum, Iris versicolor, Magnesia carbonica, Robinia pseudoacacia, Sulphuricum acidum LIQUID ORAL 20161101 UNAPPROVED HOMEOPATHIC King Bio Inc. PICEA MARIANA RESIN; ARSENIC TRIOXIDE; MARSDENIA CONDURANGO BARK; CONIUM MACULATUM FLOWERING TOP; IRIS VERSICOLOR ROOT; MAGNESIUM CARBONATE; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5023_9b0528be-28e5-48c7-b0bd-63b02de7b5fc 57955-5023 HUMAN OTC DRUG Hemorrhoid Relief Aesculus hippocastanum, Aloe socotrina, Collinsonia canadensis, Hamamelis virginiana, Muriaticum acidum, Nux vomica, Paeonia officinalis, Ratanhia, Sepia, Sulphur LIQUID ORAL 20160624 UNAPPROVED HOMEOPATHIC King Bio Inc. HORSE CHESTNUT; ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT; SEPIA OFFICINALIS JUICE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5024_4e1ef388-6cab-4298-972b-0b848666c24e 57955-5024 HUMAN OTC DRUG Indigestion Relief Antimonium crudum, Argentum nitricum, Carbo vegetabilis, Chelidonium majus, Cinchona officinalis, Graphites, Hydrastis canadensis, Ipecacuanha, Kali carbonicum, Lycopodium clavatum, Nux vomica, Pulsatilla LIQUID ORAL 20140505 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; SILVER NITRATE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5028_cbc2d11c-ab17-46cc-a0dd-03d034e33942 57955-5028 HUMAN OTC DRUG Migraine Relief Natural Medicine LIQUID ORAL 20110628 UNAPPROVED HOMEOPATHIC King Bio Inc. GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; NICKEL; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; CLAVICEPS PURPUREA SCLEROTIUM; SPIGELIA ANTHELMIA; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5030_028d6fb8-8e26-4be5-9b77-f21e3771a4f2 57955-5030 HUMAN OTC DRUG Sciatici Freee Natural Medicine LIQUID ORAL 20110613 UNAPPROVED HOMEOPATHIC Kingbio HORSE CHESTNUT; AMMONIUM CHLORIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAPSICUM; CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; PSEUDOGNAPHALIUM OBTUSIFOLIUM; STRYCHNOS IGNATII SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57955-5031_e925b621-712a-4834-bfa3-2d935c0dff68 57955-5031 HUMAN OTC DRUG Sporting Edge Arnica montana, Kali carbonicum, Kali phosphoricum, Lacticum acidum, natrum phosphoricum, Quebracho, Rhus toxicodendron, Sarcolacticum acidum, Zincum oxydatum LIQUID ORAL 20120501 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; LACTIC ACID, DL-; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; ZINC OXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5032_ffbecae3-dbd5-4a51-a043-81502c499b9b 57955-5032 HUMAN OTC DRUG TMJ / Jaw Formula Baptisia tinctoria, Calcarea fluorica, Causticum, Hepar sulphuris calcareum, Hypericum perforatum, Ignatia amara, Kalmia latifolia, Nux vomica, Phytolacca decandra, Rhus toxicodendron Sanguinaria canadensis, symphytum officinale LIQUID ORAL 20160318 UNAPPROVED HOMEOPATHIC King Bio Inc. BAPTISIA TINCTORIA ROOT; CALCIUM FLUORIDE; CAUSTICUM; CALCIUM SULFIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; KALMIA LATIFOLIA LEAF; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; COMFREY ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5038_cdb60a72-9643-4fad-b709-8c54613d86d8 57955-5038 HUMAN OTC DRUG Grief and Guilt Reliever Aurum metallicum, Cocculus indicus, Colocynthis, Gelsemium sempervirens, Hyoscyamus niger, Ignatia amara, Lachesis mutus, Natrum muriaticum, Phosphoricum acidum, Pulsatilla, Staphysagria LIQUID ORAL 20120301 UNAPPROVED HOMEOPATHIC King Bio Inc. GOLD; ANAMIRTA COCCULUS SEED; CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORIC ACID; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5041_f4e79a19-02c3-4eda-8fce-95151278d767 57955-5041 HUMAN OTC DRUG Acne Clear Natural Medicine LIQUID ORAL 20110921 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY POTASSIUM TARTRATE; ASTERIAS RUBENS; IRON; CALCIUM SULFIDE; POTASSIUM BROMIDE; SODIUM CHLORIDE; SANGUINARIA CANADENSIS ROOT; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5042_5601c2f5-69f6-406f-8846-ead13ab78979 57955-5042 HUMAN OTC DRUG Allergy Food andChemical Relief Allium sativum, Anacardium orientale, Apis mellifica, Gambogia, Mercurius solubilis, Natrum carbonicum, Nitricum acidum, Nux vomica, Phosphorus, Pulsatilla and Sulphur LIQUID ORAL 20120504 UNAPPROVED HOMEOPATHIC King Bio Inc. GARLIC; SEMECARPUS ANACARDIUM JUICE; APIS MELLIFERA; GAMBOGE; MERCURIUS SOLUBILIS; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5043_e9f34e51-9509-418a-bb3d-67f76c6e56fd 57955-5043 HUMAN OTC DRUG Allergy and Hay Fever Reliever Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Arum triphyllum, Arundo mauritanica, Euphrasia officinalis, Naphthalinum, Natrum muriaticum, Sabadilla and Wyethia helenioides LIQUID ORAL 20120105 UNAPPROVED HOMEOPATHIC King Bio Inc ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; EUPHRASIA STRICTA; NAPHTHALENE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; WYETHIA HELENIOIDES ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5045_c059e92b-4246-4acc-b3b5-4236b9f61fa3 57955-5045 HUMAN OTC DRUG Bladder Incontinence Belladonna, Bellis perennis, Benzoicum acidum, Causticum, Equisetum hyemale, Lycopodium clavatum, Phosphorus, Plantago major, Rhus aromatica, Sepia LIQUID ORAL 20120313 UNAPPROVED HOMEOPATHIC King Bio Inc. ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5049_7c01fd7d-5d1e-4b4b-bef4-289f799daa85 57955-5049 HUMAN OTC DRUG Hair and Nails Formula Adrenalinum, Antimonium crudum, Arsenicum album, Natrum muriaticum, Phosphoricum acidum, Phosphorus, Pix liquida, Selenium metallicum, Silicea, Sulphur, Thuja occidentalis LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; SODIUM CHLORIDE; PHOSPHORIC ACID; PHOSPHORUS; PINE TAR; SELENIUM; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5053_fb705177-286b-486c-9cc8-21369e6774f2 57955-5053 HUMAN OTC DRUG Lungs and Bronchial Relief Natural Medicine LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc AMMONIUM CARBONATE; ANTIMONY ARSENATE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BROMINE; ACTIVATED CHARCOAL; CHLORINE; POTASSIUM CARBONATE; LOBELIA INFLATA; TIN; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5055_d04fe7db-783e-4d2f-b0d2-0430f68bb6d9 57955-5055 HUMAN OTC DRUG Nausea and Motion Sickness Argentum nitricum, Bryonia, Cocculus indicus, Glonoinum, Lac defloratum, Petroleum, Staphysaria, Tabacum LIQUID ORAL 20120705 UNAPPROVED HOMEOPATHIC King Bio Inc. SILVER NITRATE; BRYONIA ALBA ROOT; ANAMIRTA COCCULUS SEED; NITROGLYCERIN; SKIM MILK; KEROSENE; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5058_5ae1397a-b983-4100-9754-5b10543b60f9 57955-5058 HUMAN OTC DRUG Sore Throat and Laryngitis Aconitum napellus, Antimonium crudum, Arum triphyllum, Borax, Causticum, Ferrum phosphoricum, Graphites, Hepar sulphuris calcareum, Kali bichromicum, Phosphorus, Selenium metallicum, Spongia tosta LIQUID ORAL 20140627 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARISAEMA TRIPHYLLUM ROOT; SODIUM BORATE; CAUSTICUM; FERROSOFERRIC PHOSPHATE; GRAPHITE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; PHOSPHORUS; SELENIUM; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5059_50eba846-f187-4233-9561-60d8380c800f 57955-5059 HUMAN OTC DRUG Wart Freee Antimonium crudum, Causticum, Dulcamare, Kali muriaticum, Nitricum acidum, Sabina, Staphysagria, Sulphur, Thuja occidentalis LIQUID ORAL 20140120 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; CAUSTICUM; SOLANUM DULCAMARA TOP; POTASSIUM CHLORIDE; NITRIC ACID; JUNIPERUS SABINA LEAFY TWIG; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5061_b7d735e8-f3db-4b55-9146-99cfa2b3587a 57955-5061 HUMAN OTC DRUG Blood and Kidney Detox Arsenicum album, Baptisia tinctoria, Carbo vegetabilis, Chininum sulphuricum, Cinchona officinalis, Conium maculatum, Echinacea purpurea, Ferrum metallicum, Hydrastis canadensis, Kali chloricum, Mercurius corrosivus and Serum anguillae LIQUID ORAL 20110626 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ACTIVATED CHARCOAL; QUININE SULFATE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; IRON; GOLDENSEAL; POTASSIUM CHLORATE; MERCURIC CHLORIDE; ANGUILLA ROSTRATA BLOOD SERUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5062_d3640c9f-c3e7-4bf1-9a44-aff3da2b4a7d 57955-5062 HUMAN OTC DRUG Liver Detox Arsenicum album, Baptisia tinctoria, Berberis vulgaris, Bryonia, Carduus marianus, Chelidonium majus, Chionanthus virginica, Cinchona officinalis, Lycopodium clavatum, Manganum muriaticum, Natrum sulphuricum, Nux vomica, Phosphorus, Sulphur, Taraxacum officinale LIQUID ORAL 20120917 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; MANGANESE CHLORIDE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SULFUR; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5063_671a98eb-f79f-4bb6-aead-8dd3b9f558c1 57955-5063 HUMAN OTC DRUG Lymph Detox Belladonna, Calcarea iodata, Conium maculatum, Echinacea purpurea, Hepar sulphuris calcareum, Kali iodatum, Kali muriaticum, Mercurius vivus, Phytolacca decandra, Pulsatilla, Ricinus communis, Scrophularia nodosa, Solidago virgaurea, and sulphur iodatum LIQUID ORAL 20111031 UNAPPROVED HOMEOPATHIC King Bio Inc. ATROPA BELLADONNA; CALCIUM IODIDE; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; CALCIUM SULFIDE; POTASSIUM IODIDE; POTASSIUM CHLORIDE; MERCURY; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RICINUS COMMUNIS SEED; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR IODIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5064_7986b37e-0859-46c4-b9f0-4b35882ba14c 57955-5064 HUMAN OTC DRUG Artery Cholesterol and BP Aurum metallicum, Aurum muriaticum natronatum, Baryta carbonica, Baryta muriatica, Calcarea flourica, Ceanothus americanus, Cholesterinum, Glonoinum, Plumbum iodatum, Strophanthus LIQUID ORAL 20120319 UNAPPROVED HOMEOPATHIC King Bio Inc. GOLD; SODIUM TETRACHLOROAURATE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CALCIUM FLUORIDE; CEANOTHUS AMERICANUS LEAF; CHOLESTEROL; NITROGLYCERIN; LEAD IODIDE; STROPHANTHUS HISPIDUS SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5065_a6cad210-eab5-42b9-a990-f00d408d367e 57955-5065 HUMAN OTC DRUG Heart Regularity Apocynum cannabinum, Baryta carbonica, Cactus grandiflorus, Convallaria majalis, Cypripedium pubescens, Gelsemium sempervirens, Glonoinum, Naja tripudians, Phosphorus, Spigelia anthelmia and Spongia tosta LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc. APOCYNUM CANNABINUM ROOT; BARIUM CARBONATE; SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; NAJA NAJA VENOM; PHOSPHORUS; SPIGELIA ANTHELMIA; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5070_a2a21b19-0b14-4533-be85-4c8258519414 57955-5070 HUMAN OTC DRUG Bone Strengthener Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Equisetum hyemale, Hekla lava, Phosphorus, and silicea LIQUID ORAL 20120130 UNAPPROVED HOMEOPATHIC King Bio Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; EQUISETUM HYEMALE; HEKLA LAVA; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5071_2973136a-4ddb-4a68-9918-f79c743011cb 57955-5071 HUMAN OTC DRUG ChemoClenz Arsenicum album, Cadmium sulphuricum, Ipecacuanha, Nux vomica, Phosphoricum acidum, Phosphorus, Strontium carbonicum, Tabacum, Uranium nitricum. LIQUID ORAL 20111026 UNAPPROVED HOMEOPATHIC King Bio, Inc. ARSENIC TRIOXIDE; CADMIUM SULFATE; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; STRONTIUM CARBONATE; TOBACCO LEAF; URANYL NITRATE HEXAHYDRATE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5073_9090efb8-23f7-4c69-a2b8-015104ae3410 57955-5073 HUMAN OTC DRUG Teeth and Gums Formula Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Chamomilla, Coccinella septempunctata, Coffea cruda, Hekla lava, Hypericum perforatum, Kreosotum, Ledum palustre, Magnesia phosphorica, Mercurius vivus LIQUID ORAL 20160624 UNAPPROVED HOMEOPATHIC King Bio Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; COCCINELLA SEPTEMPUNCTATA; ARABICA COFFEE BEAN; HEKLA LAVA; HYPERICUM PERFORATUM; WOOD CREOSOTE; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURY 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5074_33dec8db-5faa-417d-96bc-36006e220b58 57955-5074 HUMAN OTC DRUG UlcerPlex Anacardium orientale, Argentum nitricum, Arsenicum album, Atropinum, Carbo vegetabilis, Geranium maculatum, Kali bichromicum, Ornithogalum umbellatum uranium nitricum LIQUID ORAL 20160321 UNAPPROVED HOMEOPATHIC King Bio Inc. SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPINE; ACTIVATED CHARCOAL; GERANIUM MACULATUM ROOT; POTASSIUM DICHROMATE; ORNITHOGALUM UMBELLATUM; URANYL NITRATE HEXAHYDRATE 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5077_2ca1e4fc-ec67-46e9-9ebf-222a416f8a9a 57955-5077 HUMAN OTC DRUG Bug Away Natural Medicine LIQUID ORAL 20110805 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; HELIANTHEMUM CANADENSE; ANHYDROUS CITRIC ACID; HYPERICUM PERFORATUM; POTASSIUM NITRATE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; PULEX IRRITANS; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; SULFUR; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5078_d0ad3d17-e4f5-4c03-888d-4774d9a64e81 57955-5078 HUMAN OTC DRUG Water Retention Aceticum acidum, apis mellifica, Apocynum cannabinum, Berberis vulgaris, Cahinca, Digitalis purpurea, Helleborus niger, Hydrocotyle asiatica, Natrum muriaticum, Oxydendrum arboreum, Plumbum metallicum, Sambucus nigra, Solidago virgaurea, Strophanthus hispidus LIQUID ORAL 20160526 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; APIS MELLIFERA; APOCYNUM CANNABINUM ROOT; BERBERIS VULGARIS ROOT BARK; CHIOCOCCA ALBA ROOT; DIGITALIS; HELLEBORUS NIGER ROOT; CENTELLA ASIATICA; SODIUM CHLORIDE; OXYDENDRUM ARBOREUM LEAF; LEAD; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5080_0c0bd556-a792-477e-925d-5309fe5324b4 57955-5080 HUMAN OTC DRUG Smoke Control Natural Medicine LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; DIEFFENBACHIA SEGUINE; PHENOL; DAPHNE ODORA BARK; SYZYGIUM JAMBOS SEED; POTASSIUM PHOSPHATE, DIBASIC; LOBELIA INFLATA; NICOTINE; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; SUCROSE; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5082_17ffb26d-0f8a-4358-bca0-715a7f586853 57955-5082 HUMAN OTC DRUG Vaccinoplex Aconitum napellus, Apis mellifica, Chamomilla, Hypericum perforatum, Ledum palustre, Pulsatilla, Silicea, Thuja occidentalis LIQUID ORAL 20111026 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5083_4c28ea3f-5c2b-4e25-9efa-4ae09373bedc 57955-5083 HUMAN OTC DRUG AddictaPlex Arsenicum album, Asarum europaeum, Avena sativa, Capsicum annuum, Carbolicum acidum, Carboneum sulphuratum, Coffea cruda, Lycopodium clavatum, Nux vomica, Phytolacca decandra, stramonium, Sulphuricum acidum, Tabacum LIQUID ORAL 20160318 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; ASARUM EUROPAEUM; AVENA SATIVA FLOWERING TOP; CAPSICUM; PHENOL; CARBON DISULFIDE; ARABICA COFFEE BEAN; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; DATURA STRAMONIUM; SULFURIC ACID; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5085_cd04a41c-792e-45d1-885d-5e9e65ad2037 57955-5085 HUMAN OTC DRUG No Sweat Anti Perspirant Antimonium tartaricum, Calcarea carbonica, Cinchona officinalis, Mercurius solubilis, Mercurius vivus, Pilocarpus, Phosphoricum acidum, Sambucus nigra, Silicea and Sulphuricum acidum LIQUID ORAL 20120301 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY POTASSIUM TARTRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CINCHONA OFFICINALIS BARK; MERCURIUS SOLUBILIS; PILOCARPUS JABORANDI LEAF; PHOSPHORIC ACID; SAMBUCUS NIGRA FLOWERING TOP; SILICON DIOXIDE; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5087_78a5f2fb-e4de-4204-84c3-c274d158e147 57955-5087 HUMAN OTC DRUG Scar Freee Arnica montana, Calcarea fluorica, Calcarea phosphorica, Calendula officinalis, Graphites, Hydrofluoricum acidum, Phytolacca decandra, Sabina, Silicea, Thiosinaminum and Thuja occidentalis LIQUID ORAL 20120217 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; HYDROFLUORIC ACID; PHYTOLACCA AMERICANA ROOT; JUNIPERUS SABINA LEAFY TWIG; ALLYLTHIOUREA; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5099_4a2d2423-6ccd-40f4-9137-8716c216df23 57955-5099 HUMAN OTC DRUG Fears and Nightmares Aconitum napellus, Aurum bromatum, Calcarea carbonica, Chamomilla, Cina, Ignatia amara, Kali bromatum, Lycopodium clavatum, Paeonia officinalis, Phosphorus, Stramonium, Sulphur LIQUID ORAL 20140401 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; GOLD TRIBROMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; ARTEMISIA CINA PRE-FLOWERING TOP; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; PAEONIA OFFICINALIS ROOT; PHOSPHORUS; DATURA STRAMONIUM; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5112_8237ad01-042b-4a98-8944-65bc992c7893 57955-5112 HUMAN OTC DRUG CataClenz Eye Relief Calcarea carbonica, Calcarea fluorica, Causticum, Cineraria maritima, Euphrasia officinalis, Naphthalinum, Natrum muriaticum, Phosphorus, Quassia amara, Silicea LIQUID ORAL 20151028 UNAPPROVED HOMEOPATHIC King Bio Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; JACOBAEA MARITIMA; EUPHRASIA STRICTA; NAPHTHALENE; SODIUM CHLORIDE; PHOSPHORUS; QUASSIA AMARA WOOD; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5113_7f16b35e-1649-4f23-b66e-6474624a3d88 57955-5113 HUMAN OTC DRUG Hangover Relief Arsenicum album, Asarum europaeum, Avena sativa, Bryonia, Capsicum annuum, Carbo vegetabilis, Carboneum sulphuratum, Cinchona officinalis, Gelsemium sempervirens, Nux vomica, Paullinia sorbilis, Sulphuricum acidum LIQUID ORAL 20140718 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; ASARUM EUROPAEUM; AVENA SATIVA FLOWERING TOP; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; CARBON DISULFIDE; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; PAULLINIA CUPANA SEED; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5114_43d69ea8-6fa0-4107-8d28-09ad35ae3926 57955-5114 HUMAN OTC DRUG Newborn Tonic Aconitum napellus, Bovista, Bryonia, Chamomilla, Cinchona officinalis, Lupulinum, Mercurius vivus, Myrica cerifera, Natrum sulphuricum, Phosphorus, Sepia LIQUID ORAL 20140320 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; LYCOPERDON UTRIFORME FRUITING BODY; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; HOPS; MERCURY; MORELLA CERIFERA ROOT BARK; SODIUM SULFATE; PHOSPHORUS; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5116_610c79f7-8624-465d-87be-8e6edf2f4b47 57955-5116 HUMAN OTC DRUG Poison Ivy and Oak Relief Anacardium occidentale, clematis erecta, Croton tiglium, Cypripedium pubescens, Echinacea purpurea, Erechtites hieracifolia, Graphites, Grindelia, Histaminum hydrochloricum, Mezereum, Rhus toxicodendron, Urtica urens LIQUID ORAL 20140527 UNAPPROVED HOMEOPATHIC King Bio Inc. ANACARDIUM OCCIDENTALE FRUIT; CLEMATIS RECTA FLOWERING TOP; CROTON TIGLIUM SEED; CYPRIPEDIUM PARVIFOLUM ROOT; ECHINACEA PURPUREA; ERECHTITES HIERACIIFOLIUS; GRAPHITE; GRINDELIA HIRSUTULA WHOLE; HISTAMINE DIHYDROCHLORIDE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5120_8fa93979-5a05-40f3-85ea-c2cf4e037174 57955-5120 HUMAN OTC DRUG Snore Control Bromium, Chamomilla, Cinchona officinalis, Cuprum metallicum, Helleborus niger, Laurocerasus, Nux vomica, Phosphoricum acidum, Rhus toxicodendron, Silicea. Stramonium, Zincum metallicum LIQUID ORAL 20140630 UNAPPROVED HOMEOPATHIC King Bio Inc. BROMINE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COPPER; HELLEBORUS NIGER ROOT; PRUNUS LAUROCERASUS LEAF; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; DATURA STRAMONIUM; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5121_740fb39e-aac8-4d62-aa01-1c5d29c529e9 57955-5121 HUMAN OTC DRUG Swollen Glands Relief Astacus fluviatilis, Baryta iodata, Calcarea iodata, Cistus Canadensis, Clematis erecta, Coniinum, Iodium, Lacticum acidum, Mercurius iodatus ruber, Mercurius vivus, Phytolacca decandra, Scrophularia nodosa, Spongia tosta LIQUID ORAL 20120705 UNAPPROVED HOMEOPATHIC King Bio Inc. ASTACUS ASTACUS; BARIUM IODIDE; CALCIUM IODIDE; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; CONIINE; IODINE; LACTIC ACID, DL-; MERCURIC IODIDE; MERCURY; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5125_3c283fd7-e8c8-4046-b2e6-26fed3f45b74 57955-5125 HUMAN OTC DRUG Stye Relief Apis mellifica, Calcarea picrata, Graphites, Hepar sulphuris calcareum, Juglans regia, Lycopodium clavatum, Pulsatilla, Silicea, Staphysagria, Sulphur, Thuja occidentalis LIQUID ORAL 20160317 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; CALCIUM PICRATE; GRAPHITE; CALCIUM SULFIDE; JUGLANS REGIA FRUIT RIND, IMMATURE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5126_7d45da22-804b-4186-a037-646e3ca30352 57955-5126 HUMAN OTC DRUG Jet Lag and Shift Change Cocculus indicus, Colchicum autumnale, Gelsemium sempervirens, Juniperus communis, Kali carbonicum, Kali phosphoricum, Nux vomica, Passiflora incarnata, Phosphoricum acidum, Phosphorus LIQUID ORAL 20131008 UNAPPROVED HOMEOPATHIC King Bio Inc. ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; PHOSPHORUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5128_cd16f062-f068-41f1-b7ae-cd02b7aeb72d 57955-5128 HUMAN OTC DRUG Appetite Enhancer Alumina, Antimonium crudum, Arsenicum album, Asarum europaeum, Baptisia tinctoria, Carbolicum acidum, Chininum arsenicicum, Cocculus indicus, Lecithin, Picricum acidum, Pulsatilla, Rhus toxicodendron, Silicea and Sulphur LIQUID ORAL 20121031 UNAPPROVED HOMEOPATHIC King Bio. Inc. ALUMINUM OXIDE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; BAPTISIA TINCTORIA ROOT; PHENOL; QUININE ARSENATE; ANAMIRTA COCCULUS SEED; EGG PHOSPHOLIPIDS; PICRIC ACID; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5129_d022ae1e-174b-40c1-94a4-52c22130b6a6 57955-5129 HUMAN OTC DRUG Athletes Foot Fighter Anatherum muricatum, Alumina, Apis mellifica, Arsenicum album, Butyricum acidum, Hydrocotyle asiatica, Mezereum, Petroleum, Petroleum, rhus toxicodendron, Sepia, Silicea and Sulphur LIQUID ORAL 20110913 UNAPPROVED HOMEOPATHIC King Bio Inc. VETIVERIA ZIZANIOIDES ROOT; ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BUTYRIC ACID; CENTELLA ASIATICA; DAPHNE MEZEREUM BARK; KEROSENE; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5130_20e9bc60-fd1a-42e6-8c55-01dd737121cf 57955-5130 HUMAN OTC DRUG Odor Freee Baptisia tinctoria, Carbo animalis, Guaiacum, Lycopodium clavatum, Mercurius solubilis, Nitricum acidum, Petroleum, Sepia, Silicea, Sulphur and Thuja occidentalis LIQUID ORAL 20110913 UNAPPROVED HOMEOPATHIC King Bio Inc. BAPTISIA TINCTORIA ROOT; CARBO ANIMALIS; GUAIACUM OFFICINALE RESIN; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; KEROSENE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5133_796f9581-e6ea-4dbd-829e-3b1f6f5c069f 57955-5133 HUMAN OTC DRUG Muscle Maximizer Adrenalinum, Alfalfa, Avena sativa, Baryta carbonica, Baryta iodate, Baryta muriatica, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Lycopodium clavatum, Thuja occidentalis LIQUID ORAL 20111028 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; ALFALFA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; THUJA OCCIDENTALIS LEAFY TWIG; BARIUM IODIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5134_b30632ee-4f56-47de-9aa2-6b57b056fc89 57955-5134 HUMAN OTC DRUG Sinus Relief Natural Medicine LIQUID ORAL 20110906 UNAPPROVED HOMEOPATHIC King Bio Inc APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LEMNA MINOR; MERCURY; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5140_b0a44b5a-69d4-488a-9ea1-35254baee944 57955-5140 HUMAN OTC DRUG Nosebleed Relief Ambrosia Artemisiaefolia, Arnica montana, Bovista, Bryonia, Carbo vegetabilis, Ferrum phosphoricum, Hamamelis virginiana, Ipecacuanha, Mercurius vivus, Nitricum acidum, Phosphorus, Trillium pendulum LIQUID ORAL 20110201 UNAPPROVED HOMEOPATHIC King Bio Inc. AMBROSIA ARTEMISIIFOLIA; ARNICA MONTANA; LYCOPERDON UTRIFORME FRUITING BODY; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; FERROSOFERRIC PHOSPHATE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; IPECAC; MERCURY; NITRIC ACID; PHOSPHORUS; TRILLIUM ERECTUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5142_2b99ea5e-272e-46e3-98e6-b165b1b45962 57955-5142 HUMAN OTC DRUG Childrens Growth and Development Alfalfa, Avena sativa, Baryta carbonica, Baryta Iodata, Baryta muriatica, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Lycopodium clavatum, Thuja occidentalis LIQUID ORAL 20120822 UNAPPROVED HOMEOPATHIC King Bio Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; THUJA OCCIDENTALIS LEAFY TWIG; BARIUM IODIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5146_c7a8c2cc-bc2a-488d-86cb-89760061defc 57955-5146 HUMAN OTC DRUG Tummy Aches Natural Medicine LIQUID ORAL 20111109 UNAPPROVED HOMEOPATHIC King Bio Inc. SILVER NITRATE; BRYONIA ALBA ROOT; ANAMIRTA COCCULUS SEED; NITROGLYCERIN; SKIM MILK; KEROSENE; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; mL/59mL; [hp_X]/59mL N 20181231 57955-5149_824033ce-024d-4287-9b69-fdc94a21e9f1 57955-5149 HUMAN OTC DRUG Constitutional Enhancer Aconitum napellus, Arsenicum album, Baryta carbonica, Cantharis, Gelsemium sempervirens, Graphites, Hydrastis canadensis, Kali iodatum, Lachesis mutus, Lycopodium clavatum, Mercurius vivus, Natrum muriaticum, Nux vomica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhus toxicodendron, Sepia, Silicea and Sulphur LIQUID ORAL 20120321 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYTTA VESICATORIA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; GOLDENSEAL; POTASSIUM IODIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5150_ffaaa0e2-444a-4856-81ee-063b42c8b958 57955-5150 HUMAN OTC DRUG Good Mood Enhancer Natural Medicine LIQUID ORAL 20110824 UNAPPROVED HOMEOPATHIC King Bio Inc. SEMECARPUS ANACARDIUM JUICE; GOLD; AVENA SATIVA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; BLACK COHOSH; CINCHONA OFFICINALIS BARK; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; SODIUM CARBONATE; SODIUM SULFATE; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; mL/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5151_3df551ac-2f65-4950-b4e3-4b563fb76ac3 57955-5151 HUMAN OTC DRUG Eye Stress Agaricus muscarius, Argentum nitricum, Calcarea carbonica, Carbo vegetabilis, Gelsemium sempervirens, Graphites, Mephitis mephitica, Natrum muriaticum, Onosmodium virginianum, Phosphorus, Physostigma venenosum, Pilocarpus LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC King Bio Inc. AMANITA MUSCARIA FRUITING BODY; SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; MEPHITIS MEPHITIS ANAL GLAND FLUID; SODIUM CHLORIDE; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; PILOCARPUS JABORANDI LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5152_6082dd4c-f6a3-421c-bc8c-f1133691939b 57955-5152 HUMAN OTC DRUG Fears and Phobias Abelmoschus, Aconitum napellus, Argentum nitricum, Arsenicum album, Calcarea carbonica, Cinchona officinalis, Cocculus indicus, Gelsemium sempervirens, Kali arsenicosum, Lilium tigrinum, Lycopodium clavatum, Phosphorus, Pulsatilla and Stramonium LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc. ABELMOSCHUS MOSCHATUS SEED; ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CINCHONA OFFICINALIS BARK; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM ARSENITE ANHYDROUS; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; DATURA STRAMONIUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5153_0eaa6e75-6de5-41ca-b252-e6c306121bca 57955-5153 HUMAN OTC DRUG Headache Relief Belladonna, Bryonia, Capsicum annuum, Chininum arsenicosum, Coffea cruda, Gelsemium sempervirens, Glonoinum, Ignatia amara, Kali bichromicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia, Sulphur. SPRAY ORAL 20120308 UNAPPROVED HOMEOPATHIC King Bio Inc. ATROPA BELLADONNA; BRYONIA ALBA ROOT; CAPSICUM; QUININE ARSENITE; ARABICA COFFEE BEAN; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SPIGELIA ANTHELMIA; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5158_a4e542fa-307a-422c-b70d-63578f304217 57955-5158 HUMAN OTC DRUG Colic Relief Aethusa cynapium, Alumina, Belladonna, Borax, Chamomilla, Colocynthis, Dioscorea villosa, Ipecacuanha, Magnesia phosphorica, Natrum phosphorica, Nux vomica, Pulsatilla, Senna, Silicea, Valeriana officinalis LIQUID ORAL 20120112 UNAPPROVED HOMEOPATHIC King Bio, Inc. AETHUSA CYNAPIUM; ALUMINUM OXIDE; ATROPA BELLADONNA; SODIUM BORATE; MATRICARIA RECUTITA; DIOSCOREA VILLOSA TUBER; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; LEAD; PULSATILLA VULGARIS; SENNA LEAF; SILICON DIOXIDE; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5159_a7c67c4d-cb4b-4897-8217-8ca8b693a8e2 57955-5159 HUMAN OTC DRUG Childrens Fever Reliever Aceticum acidum, Aconitum napellus, Aesculus hippocastanum, Agaricus muscarius, Baptisia tinctoria, Belladonna, Bryonia, Chamomilla, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Pulsatilla, Rhus toxicodendron, Sambucus nigra, Sulphur and Veratrum viride. LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; ACONITUM NAPELLUS; HORSE CHESTNUT; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; VERATRUM VIRIDE ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5160_ddeecfa0-b4da-4d14-8f6c-2ad8a878d083 57955-5160 HUMAN OTC DRUG Fever Reliever Aceticum acidum, Aconitum napellus, Aesculus hippocastanum, Agaricus muscarius, Baptisia tinctoria, Belladonna, Bryonia, Chamomilla, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Pulsatilla, Rhus toxicodendron, Sambucus nigra, Sulphur, Veratrum viride LIQUID ORAL 20110913 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETIC ACID; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; VERATRUM VIRIDE ROOT; HORSE CHESTNUT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5163_a6e8768e-61be-4186-a786-288d8cc9d1cb 57955-5163 HUMAN OTC DRUG Anxiety and Nervousness Natural Medicine LIQUID ORAL 20110711 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ALFALFA; SILVER NITRATE; ARSENIC TRIOXIDE; GOLD; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; HOPS; STRYCHNOS IGNATII SEED; POTASSIUM ARSENITE ANHYDROUS; POTASSIUM PHOSPHATE, DIBASIC; HYDROCHLORIC ACID; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5164_4c282179-b231-4582-92b1-665d5e75f4a1 57955-5164 HUMAN OTC DRUG Allergy and Red Eye Relief Aconitum napellus, Allium cepa, Ambrosia artemisiaefolia, Apis mellifica, Arsenicum album, Belladonna, Cactus grandiflorus, Dulcamara, Euphrasia officinalis, Gelsemium sempervirens, Graphites, Hamamelis virginiana, Hepar sulphuris calcareum, Kali iodatum, Mercurius vivus, Natrum muriaticum, Pulsatilla, Rhus toxicodendron, Ruta graveolens,Sabadilla, Sulphur, Thuja occidentalis, Zincum metallicum LIQUID ORAL 20140422 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ONION; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; SELENICEREUS GRANDIFLORUS STEM; SOLANUM DULCAMARA TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; POTASSIUM IODIDE; MERCURY; SODIUM CHLORIDE; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5165_4a0255cd-804a-445e-ba6c-2bd6c839252a 57955-5165 HUMAN OTC DRUG Cold Sores and Herpes Apis mellifica, Arsenicum album, Borax, Capsicum annuum, Graphites, Mentha piperita, Mezereum, Natrum muriaticum, Nux vomica, Petroleum, Ranunculus bulbosus, and Rhus toxicodendron LIQUID ORAL 20120831 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; ARSENIC TRIOXIDE; SODIUM BORATE; CAPSICUM; GRAPHITE; MENTHA PIPERITA; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; KEROSENE; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5168_a232f2d7-14ab-4baf-b320-85b5fd5a782f 57955-5168 HUMAN OTC DRUG Skin Irritations and Itch Relief Natural Medicine LIQUID ORAL 20111104 UNAPPROVED HOMEOPATHIC King Bio Inc. AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ALUMINUM OXIDE; ANAGALLIS ARVENSIS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; GIANT PUFFBALL; CAUSTICUM; MUCUNA PRURIENS FRUIT TRICHOME; FAGOPYRUM ESCULENTUM; GRAPHITE; POTASSIUM CHLORIDE; HYDROCHLORIC ACID; NERIUM OLEANDER LEAF; KEROSENE; PINE TAR; RADIUM BROMIDE; TOXICODENDRON PUBESCENS LEAF; SELENIUM; SULFUR; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5181_3a2e16f3-db8b-4c5d-8461-f4ba8c917070 57955-5181 HUMAN OTC DRUG Appetite and Weight with P.H.A.T. Natural Medicine LIQUID ORAL 20110617 UNAPPROVED HOMEOPATHIC King Bio Inc. SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CORTISONE ACETATE; FUCUS VESICULOSUS; POTASSIUM DICHROMATE; NERIUM OLEANDER LEAF; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; CORTICOTROPIN; THYROID; AGRIMONIA EUPATORIA FLOWER; CASTANEA SATIVA FLOWER; SUS SCROFA PITUITARY GLAND; BOS TAURUS HYPOTHALAMUS; EPINEPHRINE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57955-5194_d2c6b03e-15ba-4ba0-9dee-9847623036bc 57955-5194 HUMAN OTC DRUG Multi Strain Flu Relief Anas barbariae, hepatis et cordis extractum, Arsenicum album, Baptisia tinctoria, Bryonia alba, Causticum, Cinchona officinalis, Echinacea purpurea, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Influenzinum, Phytolacca decandra, Rhus toxicodendron, Sarcolacticum acidum, Sulphur, Wyethia helenioides, Zincum aceticum, Zincum muriaticum and Zincum oxydatum LIQUID ORAL 20111107 UNAPPROVED HOMEOPATHIC King Bio Inc. CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; EUCALYPTUS GLOBULUS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; WYETHIA HELENIOIDES ROOT; ZINC ACETATE ANHYDROUS; ZINC CHLORIDE; ZINC OXIDE 35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5205_acabf1c2-6405-42de-999a-a38260a3f4e3 57955-5205 HUMAN OTC DRUG Nuts and Seeds Intolerances Adrenalinum, Chelidonium majus, Cucurbita pepo, semen, Histaminum hydrochloricum, Hydrastis canadensis, Ricinus communis, Sabadilla LIQUID ORAL 20131125 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; CHELIDONIUM MAJUS; PUMPKIN SEED; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; RICINUS COMMUNIS SEED; SCHOENOCAULON OFFICINALE SEED 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5206_6a204348-130e-446a-8d0f-f5a5c64f7722 57955-5206 HUMAN OTC DRUG Regional Allergies Hawaii U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Sabadilla LIQUID ORAL 20160411 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5275_346d3027-cc47-41a2-a7ff-aadb0b669d0f 57955-5275 HUMAN OTC DRUG Ear Ringing Arnica montana, Calcarea carbonica, Chenopodium anthelminticum, Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia carbonica, Manganum aceticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum, Salicylicum acidum, Thiosinaminum, Thyroidinum LIQUID ORAL 20131008 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; QUININE SALICYLATE; BLACK COHOSH; COFFEA ARABICA SEED, ROASTED; POTASSIUM IODIDE; KALMIA LATIFOLIA LEAF; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; MANGANESE CARBONATE; MERCURY; SODIUM SALICYLATE; SALICYLIC ACID; ALLYLTHIOUREA; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5283_e22cebc9-1170-47dd-a15e-358af9319daa 57955-5283 HUMAN OTC DRUG Climate Adaptation Cold and Dry Aconitum napellus, Agaricus muscarius, Asarum europaeum, Aurum metallicum, Bryonia, Camphora, Causticum, Hepar sulphuris calcareum, Hypothalamus, Kali carbonicum, Petroleum, Secale cornutum, Sepia, Thyroidinum LIQUID ORAL 20140116 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; ASARUM EUROPAEUM; GOLD; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CAUSTICUM; CALCIUM SULFIDE; BOS TAURUS HYPOTHALAMUS; POTASSIUM CARBONATE; KEROSENE; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5287_38269b85-4592-4d32-b582-009b7498170c 57955-5287 HUMAN OTC DRUG Weather Changes Alumen, Benzoicum acidum, Cadmium sulphuricum, Chelidonium majus, Colchicum autumnale, Dulcamara, Hypothalamus, Manganum aceticum, Mercurius solubilis, Natrum muriaticum, Nitricum acidum, Phosphorus, Ranunculus bulbosus, Rhododendron chrysanthum, Thyroidinum LIQUID ORAL 20130730 UNAPPROVED HOMEOPATHIC King Bio Inc. POTASSIUM ALUM; BENZOIC ACID; CADMIUM SULFATE; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; BOS TAURUS HYPOTHALAMUS; MANGANESE ACETATE TETRAHYDRATE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORUS; RANUNCULUS BULBOSUS; RHODODENDRON AUREUM LEAF; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5315_67af2571-6b32-4cb6-ac42-23973f94c88f 57955-5315 HUMAN OTC DRUG Childrens Earache Relief Aconitum napellus, Allium capa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, and Silicea LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ONION; APIS MELLIFERA; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CAUSTICUM; MATRICARIA RECUTITA; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM CHLORIDE; CALOMEL; MERCURIUS SOLUBILIS; PLANTAGO MAJOR; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5318_9bc9865d-2d57-49f8-a687-2dcafc9dba14 57955-5318 HUMAN OTC DRUG Childrens Appetite Enhancer Alumina, Antimonium crudum, Arsenicum album, Asarum europaeum, Baptisia Tinctoria, Carbolicum acidum, Chininum arsenicosum, Cocculus indicus, Lecithin, Picricum acidum, Pulsatilla, Rhus toxicodendron, Silicea, and Sulphur LIQUID ORAL 20120904 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; BAPTISIA TINCTORIA ROOT; PHENOL; QUININE ARSENITE; ANAMIRTA COCCULUS SEED; EGG PHOSPHOLIPIDS; PICRIC ACID; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; mL/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5319_00674758-a35a-45c4-98b5-46d5e55758e9 57955-5319 HUMAN OTC DRUG Foul Bowel Ammonium carbonicum, Asafoetida, Baptisia tinctoria, Carbo vegetabilis, Carbolicum acidum, Graphites, Kreosotum, Mercurius corrosivus, Oleander, Phosphorus, Rhus toxicodendron and Zincum metallicum LIQUID ORAL 20120227 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM CARBONATE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; ACTIVATED CHARCOAL; PHENOL; GRAPHITE; WOOD CREOSOTE; MERCURIC CHLORIDE; NERIUM OLEANDER LEAF; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5361_d0804a29-1a7c-4f38-9a95-84e8da99d74c 57955-5361 HUMAN OTC DRUG Jet Lag and Shift Change Alumina, Bryonia, Calcarea iodata, Cantharis, Carduus benedictus, Carduus marianus, Chelidonium majus, Cinchona officinalis, Cynara scolymus, Dioscorea villosa, Hepar sulphuris calcareum, Iris versicolor, Juniperus communis, Kali iodatum, Mercurius corrosivus, Mercurius vivus, Natrum carbonicum, Nux vomica, Plumbum metallicum, Ptelea trifoliata, Ricinus communis, Robinia pseudoacacia, Serum anguillae, Solidago virgaurea, Sulphur, Sulphuricum acidum, Taraxacum officinale LIQUID ORAL 20131008 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; BRYONIA ALBA ROOT; CALCIUM IODIDE; LYTTA VESICATORIA; CENTAUREA BENEDICTA; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; DIOSCOREA VILLOSA TUBER; CALCIUM SULFIDE; IRIS VERSICOLOR ROOT; JUNIPER BERRY; POTASSIUM IODIDE; MERCURY; MERCURIC CHLORIDE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; LEAD; PTELEA TRIFOLIATA BARK; RICINUS COMMUNIS SEED; ROBINIA PSEUDOACACIA BARK; ANGUILLA ROSTRATA BLOOD SERUM; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; SULFURIC ACID; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5510_6eaadfc9-05f9-44ba-a466-b68e5ee8429a 57955-5510 HUMAN OTC DRUG Male Libido Natural Medicine LIQUID ORAL 20110614 UNAPPROVED HOMEOPATHIC King Bio Inc CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM ROOT; PHOSPHORIC ACID; TRINITROPHENOL; SELENIUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57955-5515_0605baee-c3b1-47ba-91e7-f90f9d731f68 57955-5515 HUMAN OTC DRUG Female Libido Natural Medicine LIQUID ORAL 20111130 UNAPPROVED HOMEOPATHIC King Bio Inc. CHASTE TREE; ALETRIS FARINOSA ROOT; BERBERIS VULGARIS ROOT BARK; CAULOPHYLLUM THALICTROIDES ROOT; IRON; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; ONOSMODIUM VIRGINIANUM WHOLE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5518_ed7f9492-8fc2-47ed-a456-3a0f96aeec7b 57955-5518 HUMAN OTC DRUG ShinglePlex Arsenicum album, Capsicum annuum, Mentha piperita, Mezereum, Natrum muriaticum, Ranunculus bulbosus, Rhus toxicodendron LIQUID ORAL 20160318 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; CAPSICUM; MENTHA PIPERITA; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5566_8cea1747-2a73-465d-bde6-71a94a89eb54 57955-5566 HUMAN OTC DRUG Varicose Veins Natural Medicine LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc. HORSE CHESTNUT; ARNICA MONTANA; CALCIUM FLUORIDE; ACTIVATED CHARCOAL; SILYBUM MARIANUM SEED; COLLINSONIA CANADENSIS ROOT; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5639_37af2092-75dc-4021-9a00-a7b8de308c37 57955-5639 HUMAN OTC DRUG Sleep Aid Aconitum napellus, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis,Aesculus hippocastanum, flos LIQUID ORAL 20110715 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; ATROPA BELLADONNA; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWER; PULSATILLA VULGARIS; VALERIAN; AESCULUS HIPPOCASTANUM FLOWER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5851_3bb43abb-c5dc-4423-a77d-57b1800d57eb 57955-5851 HUMAN OTC DRUG 9-1-1 Stress Control Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Clematis erecta, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Passiflora incarnata, Phosphorous, Rhus toxicodendron, Sulphur, Symphytum officinale and Veratrum album,Clematis vitalba, flos, Impatiens glandulfera, flos, Ornithogalum Umbellatum, flos and Prunus cerasifera, flos. LIQUID ORAL 20111003 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CLEMATIS RECTA FLOWERING TOP; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWER; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; SULFUR; COMFREY ROOT; VERATRUM ALBUM ROOT; CLEMATIS VITALBA FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5930_8c67f8c5-8e9a-408b-94e1-7e4ed2e4700d 57955-5930 HUMAN OTC DRUG Mental Calm Natural Medicine LIQUID ORAL 20111128 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM FEROX ROOT; EPINEPHRINE; APIS MELLIFERA; SILVER NITRATE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; PHOSPHORUS; SCUTELLARIA LATERIFLORA; FERULA SUMBUL ROOT; THYROID, UNSPECIFIED; VIOLA ODORATA; AESCULUS HIPPOCASTANUM FLOWER; SCLERANTHUS ANNUUS FLOWERING TOP 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5954_85b455f1-3ced-4b23-8b17-152f3ccfcb42 57955-5954 HUMAN OTC DRUG Mental Alertness Alumina, Anacardium orientale, Avena sativa, Baryta carbonica, Calcarea phosphorica, Kali phosphoricum, Picricum acidum, Zincum metallicum LIQUID ORAL 20160322 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; SEMECARPUS ANACARDIUM JUICE; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; PICRIC ACID; ZINC 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5956_4189f7eb-468d-4d02-994f-668b855f1564 57955-5956 HUMAN OTC DRUG Mental Alertness for Seniors Natural Medicine LIQUID ORAL 20111205 UNAPPROVED HOMEOPATHIC King Bio Inc. CHASTE TREE; ALETRIS FARINOSA ROOT; ALUMINUM OXIDE; AVENA SATIVA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; EGG PHOSPHOLIPIDS; NUTMEG; TRINITROPHENOL; LEAD; ZINC; CARPINUS BETULUS FLOWERING TOP; CLEMATIS VITALBA FLOWER; OLEA EUROPAEA FLOWER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5979_17bf6204-e1bc-4c58-a374-369aea79c839 57955-5979 HUMAN OTC DRUG 9-1-1 Burnout Natural Medicine LIQUID ORAL 20111114 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; ALFALFA; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; AVENA SATIVA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANHYDROUS CITRIC ACID; CARBON MONOXIDE; GELSEMIUM SEMPERVIRENS ROOT; BOS TAURUS HYPOTHALAMUS; POTASSIUM PHOSPHATE, DIBASIC; EGG PHOSPHOLIPIDS; SODIUM CHLORIDE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THYROID, UNSPECIFIED; AESCULUS HIPPOCASTANUM FLOWER; CARPINUS BETULUS FLOWERING TOP; OLEA EUROPAEA FLOWER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-5984_36c9c3f8-490f-4425-8178-559ea487a54b 57955-5984 HUMAN OTC DRUG Advanced Arnica Natural Medicine LIQUID ORAL 20110927 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; ARNICA MONTANA ROOT 6; 6 [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6000_fbc76b19-2608-4066-b620-5544315c8554 57955-6000 HUMAN OTC DRUG Advanced First Aid Natural Medicine LIQUID ORAL 20111115 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; ACTIVATED CHARCOAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; TOXICODENDRON PUBESCENS LEAF; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6001_edce6486-afc9-41b1-9b38-f31fd9f73b7c 57955-6001 HUMAN OTC DRUG Indoor Air Pollution Detox Acetaldehyde, Ammonium causticum, Carboneum oxygenisatum, Chloroformum, Formalinum, Glycyrrhiza glabra, Hydrastis canadensis, Kali bichromicum, Lycopodium clavatum, Petroleum, Plumbum metallicum, Taraxacum officinale LIQUID ORAL 20140528 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETALDEHYDE; AMMONIA; CARBON MONOXIDE; CHLOROFORM; FORMALDEHYDE; GLYCYRRHIZA GLABRA; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; KEROSENE; LEAD; TARAXACUM OFFICINALE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6006_344b2382-d8af-4b7d-93e8-a2ff11c71207 57955-6006 HUMAN OTC DRUG Menopause Relief Amyl nitrosum, Calcarea carbonica, Caulophyllum thalictroides, Cimicifuga racemosa, Ferrum metallicum, Gelsemium sempervirens, Lachesis mutus, Pulsatilla, Sanguinaria canadensis, Sepia, Sulphur, Sulphuricum acidum SPRAY ORAL 20120307 UNAPPROVED HOMEOPATHIC King Bio Inc AMYL NITRITE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; IRON; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFUR; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6008_768b41a6-31db-484f-bbe5-969bae127b88 57955-6008 HUMAN OTC DRUG Morning Sickness Relief Natural Medicine LIQUID ORAL 20111026 UNAPPROVED HOMEOPATHIC King Bio Inc. ALETRIS FARINOSA ROOT; PRUNUS PERSICA FLOWER; COLCHICUM AUTUMNALE BULB; PUMPKIN SEED; IRON; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6011_51f34091-4d79-4b84-b768-415a4505346e 57955-6011 HUMAN OTC DRUG Prostate Symptom Relief Baryta carbonica, Chimaphila umbellata, Clematis erecta, Conium maculatum, Digitalis purpurea, Ferrum picricum, Phosphoricum acidum, Sabal serrulata, Selenium metallicum, Staphysagria, Thuja occidentalis, Zincum metallicum LIQUID ORAL 20111031 UNAPPROVED HOMEOPATHIC King Bio Inc. BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; FERRIC PICRATE; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6012_a067a3a9-2637-4d76-b66b-3dbbbdcbeb2d 57955-6012 HUMAN OTC DRUG Bed Wetting Natural Medicine LIQUID ORAL 20110729 UNAPPROVED HOMEOPATHIC King Bio Inc. ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6017_fd496dcd-d965-450b-9c17-29ab3b0818a6 57955-6017 HUMAN OTC DRUG Childrens Appetite Weight Natural Medicine LIQUID ORAL 20110729 UNAPPROVED HOMEOPATHIC King Bio Inc. CORTICOTROPIN; EPINEPHRINE; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CORTISONE ACETATE; FUCUS VESICULOSUS; BOS TAURUS HYPOTHALAMUS; POTASSIUM DICHROMATE; NERIUM OLEANDER LEAF; SUS SCROFA PITUITARY GLAND; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; THYROID, UNSPECIFIED; AGRIMONIA EUPATORIA FLOWER; CASTANEA SATIVA FLOWER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6021_116793df-8ad4-421e-99f3-0f9483053ea5 57955-6021 HUMAN OTC DRUG Gout Symptom Formula Natural Medicine LIQUID ORAL 20111118 UNAPPROVED HOMEOPATHIC King Bio Inc. AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6025_7cd473a8-b85f-4532-b2dd-76fd3067970a 57955-6025 HUMAN OTC DRUG Chicken Pox Symptom Relief Natural Medicine LIQUID ORAL 20111028 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ATROPA BELLADONNA; CROTON TIGLIUM SEED; GRAPHITE; CALCIUM SULFIDE; MENTHA PIPERITA; DAPHNE MEZEREUM BARK; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; PULSATILLA VULGARIS; SILICON DIOXIDE; SULFUR; ECHINACEA ANGUSTIFOLIA 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6030_3c806dbe-5051-43c1-b43f-8a4f6a1bbcc6 57955-6030 HUMAN OTC DRUG Sciatic Nerve Formula Aesculus hippocastanum, Ammonium muriaticum, Arsenicum album, Belladonna, Capsicum annuum, Causticum, Colchicum autumnale, Colocynthis, Gnaphalium polycephalum, Ignatia amara, Magnesia phosphoria, Rhus toxicodendron LIQUID ORAL 20131031 UNAPPROVED HOMEOPATHIC King Bio Inc. HORSE CHESTNUT; AMMONIUM CHLORIDE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CAPSICUM; CAUSTICUM; COLCHICUM AUTUMNALE BULB; CITRULLUS COLOCYNTHIS FRUIT PULP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; STRYCHNOS IGNATII SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6035_5e4dfbce-de1a-413d-8a53-4bb40e9d66f8 57955-6035 HUMAN OTC DRUG Leg Cramp and Spasm Relief Calcarea Carbonica, Cuprum metallicum, Gnaphalium polycephalum, Hyoscyamus niger, Ignatia amara, Magnesia phosphorica, Nux vomica, Passiflora incarnata, Platinum metallicum, Plumbum metallicum, Secale cornutum, Strychninum LIQUID ORAL 20160322 UNAPPROVED HOMEOPATHIC King Bio Inc. OYSTER SHELL CALCIUM CARBONATE, CRUDE; COPPER; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PLATINUM; LEAD; CLAVICEPS PURPUREA SCLEROTIUM; STRYCHNINE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6044_b55205dc-de78-4cc3-a2bb-7bdf698f30bb 57955-6044 HUMAN OTC DRUG Asthma Symptom Relief Natural Medicine LIQUID ORAL 20110927 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; GRINDELIA HIRSUTULA FLOWERING TOP; IPECAC; LOBELIA INFLATA; SODIUM SULFATE; .BETA.-SITOSTEROL 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6058_249d7977-e03f-4f00-a65f-256573272c37 57955-6058 HUMAN OTC DRUG Gallbladder Formula Barber vulgaris, Bryonia, Carduus marianus, Chelidonium majus, Cholesterinum, Cinchona officinalis, Colocynthis, Dioscorea villosa, Lycopodium clavatum, Natrum sulphuricum LIQUID ORAL 20110824 UNAPPROVED HOMEOPATHIC King Bio Inc. BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6083_3c8d9493-58e9-48fe-b9af-91592b78451f 57955-6083 HUMAN OTC DRUG Ileocecal Valve Detox Antimonium crudum, Arsenicum album, Cinchona officinalis, Colocynthis, Gambogia, Gentiana lutea, Magnesia phosphorica, Natrum sulphuricum, Nux vomica, Phosphorus LIQUID ORAL 20160413 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; GAMBOGE; GENTIANA LUTEA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6100_30776465-5bf0-436b-9b22-104ed03d1fb6 57955-6100 HUMAN OTC DRUG Water Chemical Detox Natural Medicine LIQUID ORAL 20110822 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; KAOLIN; BARIUM CARBONATE; BROMINE; TRIBASIC CALCIUM PHOSPHATE; CHIMAPHILA UMBELLATA; CHLORINE; FERROSOFERRIC PHOSPHATE; HYDROFLUORIC ACID; LEMNA MINOR; NITRIC ACID; LEAD; STRYCHNINE; COMFREY ROOT 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6103_1afc71d4-b8ba-4654-9637-6f89c66bc11e 57955-6103 HUMAN OTC DRUG Cosmetic and Household Detox Natural Medicine LIQUID ORAL 20110822 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; SEMECARPUS ANACARDIUM JUICE; BLATTA ORIENTALIS; FORMALDEHYDE; FUMARIA OFFICINALIS FLOWERING TOP; GLYCERIN; GRAPHITE; MAGNESIUM CHLORIDE; SODIUM PYRUVATE; NITRIC ACID; SUS SCROFA PITUITARY GLAND; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6145_997a74db-8459-4f06-8511-38d49c54e74d 57955-6145 HUMAN OTC DRUG Childrens Cough Relief Natural Medicine LIQUID ORAL 20111201 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BROMINE; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; COPPER; DROSERA ROTUNDIFOLIA; CALCIUM SULFIDE; IODINE; MEPHITIS MEPHITIS ANAL GLAND FLUID; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6147_9f54dfac-8473-4c44-94ab-156a6cb0f9c4 57955-6147 HUMAN OTC DRUG Anti-Aging and Wrinkles For Women Abrotanum, Adrenalinum, Adrenocorticotrophin, Alpha-ketoglutaricum acidum, Baryta carbonica, Calcarea fluorica, Citricum acidum, Coenzyme A, DNA, Ferrum metallicum, Glandula suprarenalis suis, Hekla lava, Helleborus niger, Hypothalamus, Lycopodium clavatum, oophorinum, RNA, Secale cornutum, Silicea, Thiaminum hydrochloricum LIQUID ORAL 20140421 UNAPPROVED HOMEOPATHIC King Bio Inc. ARTEMISIA ABROTANUM FLOWERING TOP; EPINEPHRINE; CORTICOTROPIN; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; BARIUM CARBONATE; CALCIUM FLUORIDE; ANHYDROUS CITRIC ACID; COENZYME A; HERRING SPERM DNA; IRON; SUS SCROFA ADRENAL GLAND; HEKLA LAVA; HELLEBORUS NIGER ROOT; BOS TAURUS HYPOTHALAMUS; LYCOPODIUM CLAVATUM SPORE; SUS SCROFA OVARY; SACCHAROMYCES CEREVISIAE RNA; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; THIAMINE HYDROCHLORIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6161_ad7f3126-9476-44c2-90f9-3453445aa116 57955-6161 HUMAN OTC DRUG Back Muscle and Joint Relief Natural Medicine LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc. HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6162_5ffce5f0-dec5-403e-ade1-f8ecce901659 57955-6162 HUMAN OTC DRUG Arthritis Pain and Joint Relief Natural Medicine LIQUID ORAL 20111117 UNAPPROVED HOMEOPATHIC King Bio Inc. ACTAEA SPICATA ROOT; HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; mL/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6166_7168eca7-4412-4b83-bcbf-34eefa6fef34 57955-6166 HUMAN OTC DRUG Cough Relief Natural Medicine LIQUID ORAL 20111129 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BROMINE; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; COPPER; DROSERA ROTUNDIFOLIA; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; IODINE; POTASSIUM DICHROMATE; MEPHITIS MEPHITIS ANAL GLAND FLUID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6205_7d5a865d-261a-4a43-a273-f1b7da106e03 57955-6205 HUMAN OTC DRUG Additive and Preservative Detox Natural Medicine LIQUID ORAL 20110825 UNAPPROVED HOMEOPATHIC King Bio Inc. FORMIC ACID; GAMBOGE; SODIUM BICARBONATE; SODIUM NITRATE; SODIUM NITRITE; SODIUM SULFITE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; SACCHARIN 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; mL/59mL; mL/59mL; [hp_X]/59mL N 20181231 57955-6206_074c52b8-1f19-4c9c-9b59-bf5aff709505 57955-6206 HUMAN OTC DRUG Candida Abies canadensis, Allium cepa, Allium sativum, Aloe socotrina, Antimonium crudum, Asafoetida, Borax, Candida albicans, Candida parapsilosis, Carpinus betulus, flos, Ignatia amara, Lachesis mutus, Lycopodium clavatum, Malus pumila, flos, Olea europaea, flos, Phosphoricum acidum, Phytolacca decandra, Pulsatilla, Sabadilla, Sticta pulmonaria, Sulphur, Thuja occidentalis LIQUID ORAL 20130913 UNAPPROVED HOMEOPATHIC King Bio Inc. TSUGA CANADENSIS FLOWER BUD; ONION; GARLIC; ALOE; ANTIMONY TRISULFIDE; ASAFETIDA; SODIUM BORATE; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CARPINUS BETULUS FLOWERING TOP; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MALUS DOMESTICA FLOWER; OLEA EUROPAEA FLOWER; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL; [hp_X]/236mL N 20181231 57955-6227_1236fdf2-f917-4dc5-8db8-23fdcb94ac4e 57955-6227 HUMAN OTC DRUG Acid Detox Argentum nitricum, Calcarea carbonica, Calcarea silicata, Calcarea sulphurica, Carbo vegetabilis, Natrum carbonicum, Natrum phosphoricum, Nux vomica, Robinia pseudoacacia, Sulphuricum acidum LIQUID ORAL 20130411 UNAPPROVED HOMEOPATHIC King Bio Inc. SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM SILICATE; CALCIUM SULFATE ANHYDROUS; ACTIVATED CHARCOAL; SODIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; ROBINIA PSEUDOACACIA BARK; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6235_b0336007-c36a-4bd5-8bb8-8db43c9af289 57955-6235 HUMAN OTC DRUG Restless Leg Symptom Relief Natural Medicine LIQUID ORAL 20110914 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BUFO BUFO CUTANEOUS GLAND; CAUSTICUM; MATRICARIA RECUTITA; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SULFUR; LYCOSA TARANTULA; VISCUM ALBUM FRUIT; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6286_651e46b7-3ba8-445b-9e64-67e4c22f8ead 57955-6286 HUMAN OTC DRUG Shellfish and Seafood Allergy Relief Adrenalinum, Belladonna, Bromium, Carbo animalis, Colchicum autumnale, Colocynthis, Histaminum hydrochloricum, Hydrastis canadensis, Kali carbonicum, Lycopodium clavatum, Mercurius solubilis, Pulsatilla, Urtica urens LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC King Bio Inc. EPINEPHRINE; ATROPA BELLADONNA; BROMINE; CARBO ANIMALIS; COLCHICUM AUTUMNALE BULB; CITRULLUS COLOCYNTHIS FRUIT PULP; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; URTICA URENS 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6321_e11d4b91-9420-4914-9de3-d91f27df1d43 57955-6321 HUMAN OTC DRUG Lower GI Relief Natural Medicine LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC King Bio Inc. AETHUSA CYNAPIUM; ALTHAEA OFFICINALIS ROOT; ALUMINUM OXIDE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; GAMBOGE; GRAPHITE; GRATIOLA OFFICINALIS; JUGLANS CINEREA BRANCH BARK/ROOT BARK; SKIM MILK; COW MILK; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; mL/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6486_14986699-3690-4c0d-927f-8e79abf46642 57955-6486 HUMAN OTC DRUG Fragrance and Phenolic Allergy Relief Acetaldehyde, Arsenicum album, Balsamum peruvianum, Calcarea carbonica, Carbolicum acidum, Conium maculatum, Coumarinum, Crocus sativus, Histaminum hydrochloricum, Lachesis mutus, Lycopodium clavatum, Phosphorus, Sepia LIQUID ORAL 20160318 UNAPPROVED HOMEOPATHIC King Bio Inc. ACETALDEHYDE; ARSENIC TRIOXIDE; BALSAM PERU; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; COUMARIN; SAFFRON; HISTAMINE DIHYDROCHLORIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SEPIA OFFICINALIS JUICE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6490_834a29bd-32b6-409e-b6aa-e16adbec6eb9 57955-6490 HUMAN OTC DRUG Animal Hair and Dander Allergy Relief Natural Medicine LIQUID ORAL 20111123 UNAPPROVED HOMEOPATHIC King Bio Inc. ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; HISTAMINE DIHYDROCHLORIDE; STRYCHNOS NUX-VOMICA SEED; CERVUS ELAPHUS HORN OIL; PHOSPHORUS; SILICON DIOXIDE; SULFUR 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6493_8eb707ed-51e9-48ac-bb8a-5ebcff5a19d0 57955-6493 HUMAN OTC DRUG Dairy Allergy Relief Natural Medicine LIQUID ORAL 20111003 UNAPPROVED HOMEOPATHIC King Bio Inc. AETHUSA CYNAPIUM; SEMECARPUS ANACARDIUM JUICE; CELERY SEED; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; SKIM MILK; COW MILK; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6497_6d3c98c6-5c39-41be-83b4-5610e25514f5 57955-6497 HUMAN OTC DRUG Dust Mite and Roach Allergy Relief Aralia racemosa, Blatta americana, Blatta orientalis, Chelidonium majus, Hydrastis canadensis, Linum usitatissimum, Phosphorus, Sulphur, Trifolium pratense LIQUID ORAL 20160713 UNAPPROVED HOMEOPATHIC King Bio Inc. ARALIA RACEMOSA ROOT; PERIPLANETA AMERICANA; BLATTA ORIENTALIS; CHELIDONIUM MAJUS; GOLDENSEAL; FLAX SEED; PHOSPHORUS; SULFUR; TRIFOLIUM PRATENSE FLOWER 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-6501_729bdbc5-24ed-4079-a40b-8a14dec08b13 57955-6501 HUMAN OTC DRUG Allergies Mold Arsenicum album, Baptisia tinctoria, Chloramphenicolum, Echinacea purpurea, Elaeis guineensis, Hydrastis canadensis, Mercurius solubilis,Myrrha, Nasturtium aquaticum, Nux vomica, Ricinus communis, Phosphorus, Phytolacca decandra, Pulsatilla, Sepia, Xanthoxylum fraxineum LIQUID ORAL 20150810 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CHLORAMPHENICOL; ECHINACEA PURPUREA; ELAEIS GUINEENSIS FRUIT; GOLDENSEAL; MERCURIUS SOLUBILIS; MYRRH; NASTURTIUM OFFICINALE; STRYCHNOS NUX-VOMICA SEED; RICINUS COMMUNIS SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ZANTHOXYLUM AMERICANUM BARK 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-7019_54d7f696-08f4-4545-806b-676b07162c5b 57955-7019 HUMAN OTC DRUG Constipation Symptom Formula Alumina, Bellis perennis, Causticum, Collinsonia canadensis, Hydrastis canadensis, Lac defloratum, Natrum muriaticum, Nux vomica, Plumbum metallicum, Sepia LIQUID ORAL 20130220 UNAPPROVED HOMEOPATHIC King Bio Inc. ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-7020_96abc10e-b820-4680-ba38-5a3f535f67c8 57955-7020 HUMAN OTC DRUG Diarrhea Symptom Formula Aloe socotrina, Chamomilla, Cinchona officinalis, Colocynthis, Croton tiglium, Cuprum arsenicosum, Gelsemium sempervirens, Ipecacuanha, Nux vomica, Phosphoricum acidum, Podophyllum peltatum, veratrum album LIQUID ORAL 20130220 UNAPPROVED HOMEOPATHIC King Bio Inc. ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-7023_3f50bf14-d8ee-45c0-bf28-593b713af3a3 57955-7023 HUMAN OTC DRUG Hemorrhoid Symptom Formula Aesculus hippocastanum, Aloe socotrina, Collinsonia canadensis, Hamamelis virginiana, Muriaticum acidum, Nux vomica, Paeonia officinalis, Ratanhia, Sepia, Sulphur LIQUID ORAL 20130218 UNAPPROVED HOMEOPATHIC King Bio Inc. HORSE CHESTNUT; ALOE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT; SEPIA OFFICINALIS JUICE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-7024_dc2de1ff-51b4-4b95-9806-95dab24ed040 57955-7024 HUMAN OTC DRUG Indigestion Symptom Formula Antimonium crudum, Argentum nitricum, Carbo vegetabilis, Chelidonium majus, Cinchona officinalis, Graphites, Hydrastis canadensis, Ipecacuanha, Kali carbonicum, Lycopodium clavatum, Nux vomica, Pulsatilla LIQUID ORAL 20130215 UNAPPROVED HOMEOPATHIC King Bio Inc. ANTIMONY TRISULFIDE; SILVER NITRATE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; GRAPHITE; GOLDENSEAL; IPECAC; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-7044_44c06d51-15cd-499c-ad1e-a00a442d5065 57955-7044 HUMAN OTC DRUG AsthmaCare Aconitum napellus, Adrenalinum, Ammonium carbonicum, Antimonium tartaricum, Aralia racemosa, Bromium, Chlorinum, Eriodictyon Californicum, Eucalyptus globulus, Grindelia, Lobelia inflata, Natrum sulphuricum, Phosphorus, Quebracho, Trifolium pratense LIQUID ORAL 20140401 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; EPINEPHRINE; AMMONIUM CARBONATE; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; BROMINE; CHLORINE; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; GRINDELIA HIRSUTULA WHOLE; LOBELIA INFLATA; SODIUM SULFATE; PHOSPHORUS; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; TRIFOLIUM PRATENSE FLOWER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-7145_d5617c61-e771-4a49-ad2e-3703118a154c 57955-7145 HUMAN OTC DRUG Childrens Cough Symptom Formula Aconitum napellus, Bromium, Coccus cacti, Corallium rubrum, Cuprum metallicum, Drosera, Hepar sulphuris calcareum, Iodium, Mephitis mephitica and Spongia tosta LIQUID ORAL 20130211 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; BROMINE; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; COPPER; DROSERA ROTUNDIFOLIA; CALCIUM SULFIDE; IODINE; MEPHITIS MEPHITIS ANAL GLAND FLUID; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-7225_cf46eefd-f25d-4f0d-b8da-8f64cd3f4f41 57955-7225 HUMAN OTC DRUG Stye Symptom Formula Apis mellifica, Calcarea picrata, graphites, Hepar sulphuris calcareum, Juglans regia, Lycopodium clavatum, Pulsatilla, Silicea, Staphysagria, Sulfur, Thuja occidentalis LIQUID ORAL 20131204 UNAPPROVED HOMEOPATHIC King Bio Inc. APIS MELLIFERA; CALCIUM PICRATE; GRAPHITE; CALCIUM SULFIDE; JUGLANS REGIA WHOLE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-7295_973ca5db-fc63-4973-b9c4-c64e2add0164 57955-7295 HUMAN OTC DRUG Ear Ringing Symptom Formula Arnica montana, Calcarea carbonica, Chenopodium anthelminticum, Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia carbonica, Manganum aceticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum, Salicylicum acidum, Thiosinaminum, Thyroidinum LIQUID ORAL 20131209 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; QUININE SALICYLATE; BLACK COHOSH; COFFEA ARABICA SEED, ROASTED; POTASSIUM IODIDE; KALMIA LATIFOLIA LEAF; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; MANGANESE CARBONATE; MERCURY; SODIUM SALICYLATE; SALICYLIC ACID; ALLYLTHIOUREA; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-7301_f06f18f3-e1db-407a-93af-02610b88252c 57955-7301 HUMAN OTC DRUG Soothing Advanced Arnica Arnica montana, Arnica montana, radix CREAM TOPICAL 20140507 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; ARNICA MONTANA ROOT 6; 6 [hp_X]/85g; [hp_X]/85g N 20181231 57955-7302_fe16318d-f62f-4c36-965d-97522ee8f97c 57955-7302 HUMAN OTC DRUG Cooling Acute Pain Relief Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Zincum metallicum CREAM TOPICAL 20140219 UNAPPROVED HOMEOPATHIC King Bio Inc. HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g; [hp_X]/85g N 20181231 57955-7304_126169a6-267e-4c2e-addf-49b63d447acf 57955-7304 HUMAN OTC DRUG Advanced Arnica Arnica montana, Arnica montana, radix LIQUID ORAL 20131217 UNAPPROVED HOMEOPATHIC King Bio Inc. ARNICA MONTANA; ARNICA MONTANA ROOT 6; 6 [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-7501_cd1e02de-aaf4-44d4-9094-3eedc2ad3453 57955-7501 HUMAN OTC DRUG ShinglePlex Arsenicum Album, Capsicum annuum, Mentha piperita, Mezereum, Natrum muriaticum, Ranunculus bulbosus, Rhus toxicodendron LIQUID ORAL 20150921 UNAPPROVED HOMEOPATHIC King Bio Inc. ARSENIC TRIOXIDE; CAPSICUM; DAPHNE MEZEREUM BARK; MENTHA PIPERITA; SODIUM CHLORIDE; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-7800_582ac9b2-83a1-49bb-a6eb-c6cbb81403e2 57955-7800 HUMAN OTC DRUG Skin Tag Remover Thuja occidentalis LIQUID TOPICAL 20130426 UNAPPROVED HOMEOPATHIC King Bio Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/15mL N 20181231 57955-7825_5b4243ad-bcf6-4b11-82d3-91eb25a8b836 57955-7825 HUMAN OTC DRUG Chicken Pox Symptom Relief Aconitum napellus, Antimonium tartaricum, Apis mellifica, Balladonna, Croton tiglium, Echinacea, Graphites, Hepar sulphuris calcareum, Mentha piperita, Mezereum, Pulsatilla, Ranunculus bulbosus, Rhus toicodendron, Silcea, Sulphur LIQUID ORAL 20160713 UNAPPROVED HOMEOPATHIC King Bio Inc. ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ATROPA BELLADONNA; CROTON TIGLIUM SEED; ECHINACEA, UNSPECIFIED; GRAPHITE; CALCIUM SULFIDE; MENTHA PIPERITA; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-8020_495b4e9e-13fa-48c0-94e0-d530ce913b8f 57955-8020 HUMAN OTC DRUG Candida High Potency 9 Aquaflora LIQUID ORAL 20110708 UNAPPROVED HOMEOPATHIC King Bio Inc. GARLIC; ALOE; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; MALUS DOMESTICA FLOWER; CARPINUS BETULUS FLOWERING TOP; OLEA EUROPAEA FLOWER; TSUGA CANADENSIS FLOWER BUD; ONION; ANTIMONY TRISULFIDE; ASAFETIDA; SODIUM BORATE; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; SULFUR; THUJA OCCIDENTALIS LEAF 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 57955-8058_381e7438-8fd7-4d0d-b122-b3d92cc692fe 57955-8058 HUMAN OTC DRUG Gallbladder Symptom Formula Berberis vulgaris, Bryonia alba, Carduus marianus, Chelidonium majus, Cholesterinum, Cinchona officinalis, Colocynthis, Dioscorea villosa, Lycopodium clavatum and Natrum sulphuricum LIQUID ORAL 20130220 UNAPPROVED HOMEOPATHIC King Bio Inc. BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-8148_014f77d7-a396-4e7d-a3d2-d9a949c08f6c 57955-8148 HUMAN OTC DRUG Anti Aging and Wrinkles For Women Abrotanum, Adrenalinum, Adrenocorticotrophin, Alpha-Ketoglutaricum acidum, Alpha-Lipoicum acidum, Baryta carbonica, Calcarea fluorica, Citricum acidum, Coenzyme A, DNA, Ferrum metallicum, Glandula suprarenalis suis, Hekla lava, Helleborus niger, Hypothalamus, Lycopodium clavatum, Oophorinum, RNA, Secale Cornutum, Silicea, Thiaminum hydrochloricum LIQUID ORAL 20130827 UNAPPROVED HOMEOPATHIC King Bio Inc. ARTEMISIA ABROTANUM FLOWERING TOP; EPINEPHRINE; CORTICOTROPIN; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; BARIUM CARBONATE; CALCIUM FLUORIDE; ANHYDROUS CITRIC ACID; COENZYME A; HERRING SPERM DNA; IRON; SUS SCROFA ADRENAL GLAND; HEKLA LAVA; HELLEBORUS NIGER ROOT; BOS TAURUS HYPOTHALAMUS; LYCOPODIUM CLAVATUM SPORE; SUS SCROFA OVARY; SACCHAROMYCES CEREVISIAE RNA; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; THIAMINE HYDROCHLORIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-8150_139f254f-aec9-4bfa-bfd8-90c44efeb4c1 57955-8150 HUMAN OTC DRUG Good Mood Enhancer Agrimonia eupatoria, flos, Anacardium orientale, Aurum metallicum, Avena sativa, Borago officinalis, Calcarea carbonica, Capsicum annuum, Carpinus betulus, flos, Cimicifuga racemosa, Cinchona officinalis, Hypericum perforatum, Ignatia amara, Kali bromatum, Larix decidua, flos, Natrum carbonicum, Natrum sulphuricum, Phosphoricum acidum, Phosphorus, Pulsatilla, Sepia, Sinapis arvensis, flos, Tabacum LIQUID ORAL 20131031 UNAPPROVED HOMEOPATHIC King Bio Inc. AGRIMONIA EUPATORIA FLOWER; SEMECARPUS ANACARDIUM JUICE; GOLD; AVENA SATIVA FLOWERING TOP; BORAGE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CARPINUS BETULUS FLOWERING TOP; BLACK COHOSH; CINCHONA OFFICINALIS BARK; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; LARIX DECIDUA FLOWERING TOP; SODIUM CARBONATE; SODIUM SULFATE; PHOSPHORIC ACID; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; TOBACCO LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-8195_e33b89f7-bdeb-41d1-825e-216c8d7544ef 57955-8195 HUMAN OTC DRUG Regional Allergies Desert U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Alfalfa, Allium cepa, Ambrosia artemisiaefolia, Cortisone aceticum, Erechtites hieracifolia, Erigeron canadensis, Euonymus atropurpureus, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Sabadilla, Stramonium and Triticum repens LIQUID ORAL 20130709 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ALFALFA; ONION; AMBROSIA ARTEMISIIFOLIA; CORTISONE ACETATE; ERECHTITES HIERACIIFOLIUS; CONYZA CANADENSIS; EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; DATURA STRAMONIUM; ELYMUS REPENS ROOT 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-8196_0df89fa5-0b39-48bf-9e1e-48f6925ee3dd 57955-8196 HUMAN OTC DRUG Regional Allergies Great Lakes U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolia, Chelidonium majus, Chenopodium vulvaria, Cichorium intybus, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Hedera helix, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Pulsatilla nuttalliana, RNA, Sabadilla, Teucrium scorodonia LIQUID ORAL 20160412 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; AMBROSIA ARTEMISIIFOLIA; CHELIDONIUM MAJUS; CHENOPODIUM VULVARIA; CHICORY ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; ANEMONE PATENS; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; TEUCRIUM SCORODONIA FLOWERING TOP 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-8197_73c8e7eb-7d6f-40cf-b36b-73461d5ecca2 57955-8197 HUMAN OTC DRUG Regional Allergies Northeastern US Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agraphis nutans, Allium cepa, Collinsonia canadensis, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Salvia officinalis, Tanacetum vulgare, Trifolium pratense, Vinca minor LIQUID ORAL 20130709 UNAPPROVED HOMEOPATHIC King Bio Inc, ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; HYACINTHOIDES NON-SCRIPTA; ONION; COLLINSONIA CANADENSIS ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; SAGE; TANACETUM VULGARE TOP; TRIFOLIUM PRATENSE FLOWER; VINCA MINOR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-8198_4d8023d2-5d6e-40d6-b87e-45ee99f887fa 57955-8198 HUMAN OTC DRUG Regional Allergies Pacific US adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, alfalfa, allium cepa, Bellis perennis, conium maculatum, cortisone aceticum, equisetum hyemale, euphrasia officinalis, Fagopyrum esculentum, galphimia glauca, histaminum hydrochloricum, kali muriaticum, millefolium, mucosa nasalis suis, natrum muriaticum, prunus spinosa, RNA, Sabadilla, Solidago virgaurea LIQUID ORAL 20160411 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ALFALFA; ONION; BELLIS PERENNIS; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EQUISETUM HYEMALE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; ACHILLEA MILLEFOLIUM; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PRUNUS SPINOSA FLOWER BUD; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-8199_70cc49df-56e5-4d1f-89da-9d93973fe094 57955-8199 HUMAN OTC DRUG Regional Allergies Plains U.S. Absinthium, Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolla, Caulophyllum thalictroides, Conium maculatum, Cortisone aceticum, Euphrasia officinalis, Fagopyrum esculentum, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Melilotus officinalis, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Secale cornutum LIQUID ORAL 20130924 UNAPPROVED HOMEOPATHIC King Bio Inc. WORMWOOD; ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; AMBROSIA ARTEMISIIFOLIA; CAULOPHYLLUM THALICTROIDES ROOT; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; MELILOTUS OFFICINALIS TOP; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; CLAVICEPS PURPUREA SCLEROTIUM 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-8200_d90a7be9-0931-4dff-a852-c17f75f92684 57955-8200 HUMAN OTC DRUG Regional Allergies Rocky Mtns. U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, Agrostemma githago, Ailanthus glandulosus, Allium cepa, Cortisone aceticum, Cynodon dactylon, Equisetum hyemale, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Platanus, Populus candicans, RNA, Sabadilla, Solidago virgaurea LIQUID ORAL 20130812 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; AGRIMONIA EUPATORIA; AGROSTEMMA GITHAGO SEED; AILANTHUS ALTISSIMA FLOWERING TWIG; ONION; CORTISONE ACETATE; CYNODON DACTYLON; EQUISETUM HYEMALE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PLATANUS OCCIDENTALIS WHOLE; POPULUS BALSAMIFERA LEAF BUD; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-8201_dc4e2c6d-9b6e-4540-b6ca-288ec6c64bae 57955-8201 HUMAN OTC DRUG Regional Allergies Southern U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Nasturtium aquaticum, Natrum muriaticum, RNA, Rhus toxicodendron, Sabadilla, Sassafras officinale LIQUID ORAL 20130927 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; ALNUS SERRULATA BARK; CENTAUREA BENEDICTA; CHICORY ROOT; CORTISONE ACETATE; MUCUNA PRURIENS FRUIT TRICHOME; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; NASTURTIUM OFFICINALE; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SASSAFRAS ALBIDUM ROOT BARK 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-8202_f51b6634-115f-4769-ab52-1888c99e3442 57955-8202 HUMAN OTC DRUG Regional Allergies Southwestern U.S. Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Asarum canadense, Cortisone aceticum, Eupatorium aromaticum, Euphrasia officinalis, Fraxinus americana, Galphimia glauca, Helianthus annuus, Histaminum hydrochloricum, Juniperus virginiana, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Plantago major, RNA, Rumex crispus, Sabadilla, Senecio jacobaea LIQUID ORAL 20160412 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; ASARUM CANADENSE ROOT; CORTISONE ACETATE; AGERATINA AROMATICA ROOT; EUPHRASIA STRICTA; FRAXINUS AMERICANA BARK; GALPHIMIA GLAUCA FLOWERING TOP; HELIANTHUS ANNUUS FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PLANTAGO MAJOR; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; JACOBAEA VULGARIS 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 57955-8300_59a27717-88eb-4b8e-b6de-bc80f14c2a68 57955-8300 HUMAN OTC DRUG Food Intolerances Aethusa cynapium, Calcarea carbonica, Cucurbita pepo, semen, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum carbonicum, Nitricum acidum, Nux vomica, Ovi gallinae pellicula, Phosphorus, Pulsatilla, Sulphur LIQUID ORAL 20131104 UNAPPROVED HOMEOPATHIC King Bio Inc. AETHUSA CYNAPIUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PUMPKIN SEED; GAMBOGE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; EGG SHELL MEMBRANE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-8310_63a50433-ae89-4dd1-87c7-0140f47858b2 57955-8310 HUMAN OTC DRUG Pet Hair and Dander Allergies Aralia racemosa, Arsenicum album, Histaminum hydrochloricum, Nux vomica, Oleum animale, Phosphorus, Silicea, Sulphur LIQUID ORAL 20131112 UNAPPROVED HOMEOPATHIC King Bio Inc. ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; HISTAMINE DIHYDROCHLORIDE; STRYCHNOS NUX-VOMICA SEED; CERVUS ELAPHUS HORN OIL; PHOSPHORUS; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-8315_0d634610-703e-48c5-9356-8bdefe43ebd7 57955-8315 HUMAN OTC DRUG Midwest Regional Allergies Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolia, Cichorium intybus, Conium maculatum, Cortisone aceticum, Euphrasia officinalis, Fagopyrum esculentum, Galphimia glauca, Hedera helix, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Secale cornutum LIQUID ORAL 20131104 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; AMBROSIA ARTEMISIIFOLIA; CHICORY ROOT; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; CLAVICEPS PURPUREA SCLEROTIUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-8325_6a68ab31-cef2-4779-a9ec-50830766b1e9 57955-8325 HUMAN OTC DRUG Northeast Regional Allergies Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agraphis nutans, Allium cepa, Collinsonia canadensis, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Salvia officinalis, Tanacetum vulgare, Trifolium pratense, Vinca minor LIQUID ORAL 20131104 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; HYACINTHOIDES NON-SCRIPTA; ONION; COLLINSONIA CANADENSIS ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; SAGE; TANACETUM VULGARE TOP; TRIFOLIUM PRATENSE FLOWER; VINCA MINOR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-8330_69496972-6b6f-46d0-9184-f98ac902489c 57955-8330 HUMAN OTC DRUG Pacific Regional Allergies Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Alfalfa, Allium cepa, Bellis perennis, Conium maculatum, Cortisone aceticum, Equisetum hyemale, Euphrasia officinalis, Fagopyrum esculentum, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Millefolium, Mucosa nasalis suis, Natrum muriaticum, Prunus spinosa, RNA, Sabadilla, Solidago virgaurea LIQUID ORAL 20131126 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ALFALFA; ONION; BELLIS PERENNIS; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EQUISETUM HYEMALE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; ACHILLEA MILLEFOLIUM; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PRUNUS SPINOSA FLOWER BUD; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-8345_bca09038-3e58-4194-8867-6c994b152ce5 57955-8345 HUMAN OTC DRUG Southeast Regional Allergies Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Nasturtium aquaticum, Natrum muriaticum, RNA, Rhus toxicodendron, Sabadilla, Sassafras officinale LIQUID ORAL 20131031 UNAPPROVED HOMEOPATHIC King Bio Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; ALNUS SERRULATA BARK; CENTAUREA BENEDICTA; CHICORY ROOT; CORTISONE ACETATE; MUCUNA PRURIENS FRUIT TRICHOME; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; NASTURTIUM OFFICINALE; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SASSAFRAS ALBIDUM ROOT BARK 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 57955-8699_fefda55e-4ca9-4ae0-a9f1-3e36db41e251 57955-8699 HUMAN OTC DRUG Skin Tag Remover Thuja occidentalis LIQUID TOPICAL 20140108 UNAPPROVED HOMEOPATHIC King Bio Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/15mL N 20181231 57957-0007_8bcf4ae2-a9cf-4e0b-9be2-f52361c956aa 57957-0007 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19760101 UNAPPROVED MEDICAL GAS Bernens Convalescent Pharmacy, Inc OXYGEN 99 L/100L N 20181231 57959-123_60c70d70-aa04-7644-e053-2a91aa0a7cf6 57959-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20151202 UNAPPROVED MEDICAL GAS Home Care Equipment, Inc. OXYGEN 99 L/100L N 20181231 57962-070_56aba169-81c9-4d4a-8640-9d92ec5ac704 57962-070 HUMAN PRESCRIPTION DRUG IMBRUVICA Ibrutinib CAPSULE ORAL 20171220 NDA NDA205552 Pharmacyclics LLC IBRUTINIB 70 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 57962-140_56aba169-81c9-4d4a-8640-9d92ec5ac704 57962-140 HUMAN PRESCRIPTION DRUG IMBRUVICA Ibrutinib CAPSULE ORAL 20131113 NDA NDA205552 Pharmacyclics LLC IBRUTINIB 140 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 57963-101_6eafa4df-b743-4c70-9fe1-97c30b07d82d 57963-101 HUMAN OTC DRUG Meclizine 25 MECLIZINE HYDROCHLORIDE TABLET ORAL 20161201 OTC MONOGRAPH FINAL part336 The Generic Pharmaceutical Company MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 57963-103_5ac8a5e7-a66e-4f56-86b8-0a2b38fc06d9 57963-103 HUMAN OTC DRUG G Tussin AC CODEINE PHOSPHATE and GUAIFENESIN LIQUID ORAL 20161201 OTC MONOGRAPH FINAL part341 The Generic Pharmaceutical Company CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 57970-100_7dcea8f6-ed83-4355-b2a7-54f6dd079125 57970-100 HUMAN PRESCRIPTION DRUG DALVANCE Dalbavancin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140523 NDA NDA021883 Durata Therapeutics Inc. DALBAVANCIN HYDROCHLORIDE 500 mg/25mL Lipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [Chemical/Ingredient] E 20171231 57975-161_d78c79d0-20b6-4e46-b3f9-7facbd3a2c9f 57975-161 HUMAN OTC DRUG Regeneration Wrinkle Control Cream SPF 15 Avobenzone, Homosalate, Octocrylene CREAM TOPICAL 20140315 OTC MONOGRAPH NOT FINAL part352 BeautiControl AVOBENZONE; OCTOCRYLENE; HOMOSALATE 3; 5; 10 g/100g; g/100g; g/100g E 20171231 57993-001_eed677b6-a42f-45c6-acff-5ed5c64d0c9d 57993-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Sanford HealthCare Accessories, LLC OXYGEN 99 L/100L E 20171231 57994-008_b175b0fd-79f5-4001-b371-30e859522c5b 57994-008 HUMAN PRESCRIPTION DRUG LEVONORGESTREL AND ETHINYL ESTRADIOL levonorgestrel and ethinyl estradiol KIT 20170101 ANDA ANDA200493 Jai Pharma Limited N 20181231 58004-001_14e0493a-16da-457b-ac2a-9010677ba378 58004-001 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130427 OTC MONOGRAPH NOT FINAL part333A NATIONWIDE PROMOTIONS LLC ALCOHOL 62 mL/100mL E 20171231 58004-002_b47ccf71-bfd1-4e5d-8ee4-91d996bbd4f7 58004-002 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol SPRAY TOPICAL 20130427 OTC MONOGRAPH NOT FINAL part333A NATIONWIDE PROMOTIONS LLC ALCOHOL 62 mL/100mL E 20171231 58029-223_8dc6340b-dc85-499c-bc87-a188e1629133 58029-223 HUMAN OTC DRUG zinc oxide zinc oxide OINTMENT TOPICAL 20110201 OTC MONOGRAPH FINAL part347 Gerimedix Incorporated ZINC OXIDE 1.8 g/100g N 20181231 58029-224_dd02a0d6-354e-405e-a60b-64410c9bd44d 58029-224 HUMAN OTC DRUG GeriGard zinc oxide OINTMENT TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Gerimedix Incorporated ZINC OXIDE 1.8 g/100g N 20181231 58048-0001_97e0a393-459c-4ee5-9c5d-cfe68f83ab7b 58048-0001 HUMAN OTC DRUG Lyme and Co-Infection Nosode Angelica Archangelica, Hydrastis Canadensis, Kali Muriaticum, Yucca Filamentosa, Cartilago Suis, Phytolacca Decandra, Rhus Toxicodendron LIQUID ORAL 20131004 20210928 UNAPPROVED HOMEOPATHIC BioPure Healing Products, LLC ANGELICA ARCHANGELICA ROOT; GOLDENSEAL; POTASSIUM CHLORIDE; YUCCA FILAMENTOSA; SUS SCROFA CARTILAGE; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; CAUSTICUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE; OXALIC ACID; ARNICA MONTANA; CHLAMYDIA TRACHOMATIS; BABESIA MICROTI; BORRELIA BURGDORFERI; LATRODECTUS MACTANS; ANHYDROUS CITRIC ACID; HUMAN HERPESVIRUS 5; RICKETTSIA RICKETTSII; JAPANESE ENCEPHALITIS VIRUS; LEDUM PALUSTRE TWIG 2; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 6; 6; 8; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 58048-0002_ffb8bd11-dc98-46c6-849c-0763fd31ae57 58048-0002 HUMAN OTC DRUG Lyme and Co-Infection Nosode Angelica Archangelica, Hydrastis Canadensis, Kali Muriaticum, Yucca Filamentosa, Cartilago Suis, Phytolacca Decandra, Rhus Tox, Causticum, Magnesia Phosphorica, Manganum Metallicum, Oxalicum Acidum, Arnica Montana, Chlamydia Trachomatis, Babesia Microti, Borrelia Burgdorferi Nosode, Latrodectus Mactans, Citricum Acidum, Cytomegalovirus Nosode, Rickettsia Prowazekii, Encephalitis Nosode, Ledum Palustre LIQUID ORAL 20170421 UNAPPROVED HOMEOPATHIC BioPure Healing Products, LLC ANGELICA ARCHANGELICA ROOT; GOLDENSEAL; POTASSIUM CHLORIDE; YUCCA FILAMENTOSA; SUS SCROFA CARTILAGE; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; CAUSTICUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE; OXALIC ACID; ARNICA MONTANA; CHLAMYDIA TRACHOMATIS; BABESIA MICROTI; BORRELIA BURGDORFERI; LATRODECTUS MACTANS; ANHYDROUS CITRIC ACID; HUMAN HERPESVIRUS 5; RICKETTSIA PROWAZEKII; JAPANESE ENCEPHALITIS VIRUS; LEDUM PALUSTRE TWIG 2; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 6; 6; 8; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 58048-0003_67876a3a-2aa4-400f-939e-185237ba94b1 58048-0003 HUMAN OTC DRUG Lyme and Co-Infection Nosode Angelica Archangelica, Kali Muriaticum, Yucca Filamentosa, Cartilago Suis, Phytolacca Decandra, Hydrastis Canadensis, Rhus Tox, Causticum, Magnesia Phosphorica, Manganum Metallicum, Oxalicum Acidum, Arnica Montana, Chlamydia Trachomatis, Babesia Microti, Borrelia Burgdorferi Nosode, Latrodectus Mactans, Citricum Acidum, Cytomegalovirus Nosode, Rickettsia Prowazekii, Encephalitis Nosode, Ledum Palustre LIQUID ORAL 20170606 UNAPPROVED HOMEOPATHIC BioPure Healing Products, LLC ANGELICA ARCHANGELICA ROOT; POTASSIUM CHLORIDE; YUCCA FILAMENTOSA; SUS SCROFA CARTILAGE; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; TOXICODENDRON PUBESCENS LEAF; CAUSTICUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE; OXALIC ACID; ARNICA MONTANA; CHLAMYDIA TRACHOMATIS; BABESIA MICROTI; BORRELIA BURGDORFERI; LATRODECTUS MACTANS; ANHYDROUS CITRIC ACID; HUMAN HERPESVIRUS 5; RICKETTSIA PROWAZEKII; JAPANESE ENCEPHALITIS VIRUS; LEDUM PALUSTRE TWIG 2; 3; 3; 3; 3; 5; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 6; 6; 8; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 58060-002_5e7d3c21-bbf5-a36e-e053-2a91aa0a1d0b 58060-002 HUMAN PRESCRIPTION DRUG Radiogardase Prussian blue insoluble capsules CAPSULE ORAL 20100324 NDA NDA021626 Heyl Chem.-pharm. Fabrik GmbH & Co. KG FERRIC FERROCYANIDE 500 mg/1 Decorporation Agent [EPC],Ion Exchange Activity [MoA],Chelating Activity [MoA] N 20181231 58066-7001_de763c5e-cdaa-455e-b5d7-dc8505748549 58066-7001 HUMAN OTC DRUG Acne Free Antimonium tartaricum, Asterias rubens, Ferrum metallicum, Hepar sulphuris calcareum, Kali bromatum, Lac defloratum, Natrum muriaticum, Sanguinaria canadensis, Selenium metallicum, Sepia, Silicea, Sulphur, Thuja occidentalis LIQUID ORAL 20140115 UNAPPROVED HOMEOPATHIC Beaumont Bio Med ANTIMONY POTASSIUM TARTRATE; ASTERIAS RUBENS; IRON; CALCIUM SULFIDE; POTASSIUM BROMIDE; SKIM MILK; SODIUM CHLORIDE; SANGUINARIA CANADENSIS ROOT; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL N 20181231 58066-7002_7a6df16b-e570-419a-9b7c-0d87c0c0c5a8 58066-7002 HUMAN OTC DRUG Skin Irritation and Itch Response Agaricus muscarius, Alumina, Anagallis arvensis, Antimonium tartaricum, Apis mellifica, Arsenicum album, Arsenicum iodatum, Bovista, Causticum, Dolichos pruriens, Fagapyrum esculentum, Graphites, Kali muriaticum, Lac defloratum, Muriaticum acidum, Oleander, Petroleum, Pix Liquida, Radium bromatum, Rhus toxicodendron, Selenium metallicum, Sulphur, Urtica urens LIQUID ORAL 20130116 UNAPPROVED HOMEOPATHIC Beaumont Bio Med AMANITA MUSCARIA FRUITING BODY; ALUMINUM OXIDE; ANAGALLIS ARVENSIS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; LYCOPERDON UTRIFORME FRUITING BODY; CAUSTICUM; MUCUNA PRURIENS FRUIT TRICHOME; FAGOPYRUM ESCULENTUM; GRAPHITE; POTASSIUM CHLORIDE; SKIM MILK; HYDROCHLORIC ACID; NERIUM OLEANDER LEAF; KEROSENE; PINE TAR; RADIUM BROMIDE; TOXICODENDRON PUBESCENS LEAF; SELENIUM; SULFUR; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 10; 10; 10; 10 [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL N 20181231 58066-7003_8ee9b0ed-fe1e-4d50-962a-abafb3bbe822 58066-7003 HUMAN OTC DRUG Gland Discomfort Relief Astacus fluviatilis, Baryta iodata, Calcarea iodata, Cistus canadensis, Clematis erecta, Conium maculatum, Iodium, Lacticum acidum, Lac defloratum, Mercurius iodatus ruber, Mercurius vivus, Phytolacca decandra, Scrophularia nodosa, Spongia tosta LIQUID ORAL 20120417 UNAPPROVED HOMEOPATHIC Beaumont Bio Med ASTACUS ASTACUS; BARIUM IODIDE; CALCIUM IODIDE; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; IODINE; LACTIC ACID, DL-; SKIM MILK; MERCURIC IODIDE; MERCURY; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL N 20181231 58066-7011_1d438c06-dea7-46be-941f-cb28d923bee5 58066-7011 HUMAN OTC DRUG Allergy and Hay Fever Relief Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Arum triphyllum, Arundo mauritanica, Euphrasia officinalis, Lac defloratum, Naphthalinum, Natrum muriaticum, Sabadilla, Wyethia helenioides LIQUID ORAL 20160502 UNAPPROVED HOMEOPATHIC Beaumont Bio Med ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIOXIDE; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; EUPHRASIA STRICTA; SKIM MILK; NAPHTHALENE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; WYETHIA HELENIOIDES ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL N 20181231 58066-7012_26524d1f-7d83-474b-ba8a-b5f4e0901d81 58066-7012 HUMAN OTC DRUG Colds and Flu Response Anas barbariae, hepatis et cordis extractum, Arsenicum album, Baptisia tinctoria, Bryonia, Dulcamara, Echinacea, Echinacea purpurea, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Kali muriaticum, Lac defloratum, Phosphorus, Pulsatilla, Sulphur, Zincum aceticum, Zincum carbonicum, Zincum metallicum, Zincum muriaticum, Zincum oxydatum, Zincum picricum, Zincum valerianicum LIQUID ORAL 20160428 UNAPPROVED HOMEOPATHIC Beaumont Bio Med CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; SOLANUM DULCAMARA TOP; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM CHLORIDE; SKIM MILK; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; ZINC ACETATE ANHYDROUS; ZINC CARBONATE; ZINC; ZINC CHLORIDE; ZINC OXIDE; ZINC PICRATE NONAHYDRATE; ZINC VALERATE DIHYDRATE 50; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; 1/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL N 20181231 58066-7013_36749330-05bb-4ca8-8efe-2c5cc70c80ae 58066-7013 HUMAN OTC DRUG Sinus Response Apis mellifica, Baptisia tinctoria, Colocynthis, Hepar sulphuris calcareum, Histaminum hydrochloricum, Hydrastis canadensis, Ignatia amara, Kali bichromicum, Lac defloratum, Lemna minor, Mercurius vivus, Pulsatilla, Rhus toxicodendron, Sabadilla, Thuja occidentalis LIQUID ORAL 20160912 UNAPPROVED HOMEOPATHIC Beaumont Bio Med APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; SKIM MILK; LEMNA MINOR; MERCURY; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL N 20181231 58066-7014_dc668798-dd9b-4af5-be07-3877c8462cc4 58066-7014 HUMAN OTC DRUG Sore Throat and Laryngitis Response Aconitum napellus, Antimonium crudum, Arum triphyllum, Borax, Causticum, Ferrum phosphoricum, Graphites, Hepar sulphuris calcareum, Kali bichromicum, Lac defloratum, Phosphorus, Selenium metallicum, Spongia tosta LIQUID ORAL 20111220 UNAPPROVED HOMEOPATHIC Beaumont Bio Med ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ARISAEMA TRIPHYLLUM ROOT; SODIUM BORATE; CAUSTICUM; FERROSOFERRIC PHOSPHATE; GRAPHITE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; SKIM MILK; PHOSPHORUS; SELENIUM; SPONGIA OFFICINALIS SKELETON, ROASTED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL N 20181231 58066-7022_0ddfb6a6-e5f0-472a-a4a1-789fbb71ea36 58066-7022 HUMAN OTC DRUG Diarrhea Response Aloe socotrina, Chamomilla, Cinchona officinalis, Colocynthis, Colostrum, Croton tiglium, Cuprum arsenicosum, Gelsemium sempervirens, Ipecacuanha, Nux vomica, Phosphoricum acidum, Podophyllum peltatum, Veratrum album LIQUID ORAL 20110908 UNAPPROVED HOMEOPATHIC Beaumont Bio Med ALOE; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; BOS TAURUS COLOSTRUM; CROTON TIGLIUM SEED; CUPRIC ARSENITE; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PODOPHYLLUM; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL N 20181231 58066-7041_9dcc7484-600c-4d4c-b2d9-10169649782c 58066-7041 HUMAN OTC DRUG Muscle and Joint Pain Relief Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea Fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Lac vaccinum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Zincum metallicum LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC Beaumont Bio Med HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; COW MILK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL N 20181231 58066-8012_abcecb19-db8b-49a8-8c0a-132bd8acd43f 58066-8012 HUMAN OTC DRUG Four Seasons Flu Relief Anas barbariae, hepatis et cordis extractum, Arsenicum album, Baptisia tinctoria, Bryonia alba, Causticum, Cinchona officinalis, Dulcamara, Echinacea purpurea, Eucalyptus globulus, Eupatorium purpureum, Gelsemium sempervirens, Influenzinum, Lac defloratum, Lachesis mutus, Phytolacca decandra, Rhus toxicodendron, Sarcolacticum acidum, Sulphur, Wyethia helenioides LIQUID ORAL 20150108 UNAPPROVED HOMEOPATHIC Beaumont Bio Med CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA TOP; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; EUTROCHIUM PURPUREUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; SKIM MILK; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; WYETHIA HELENIOIDES ROOT 35; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_C]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL; [hp_X]/59.2mL N 20181231 58069-010_7b51f02c-9e36-4469-97ac-c6baec73b6fe 58069-010 HUMAN OTC DRUG Version X Scalp Tonic Allantoin LIQUID TOPICAL 20130201 OTC MONOGRAPH FINAL part347 CHRISTLTD ALLANTOIN .625 mg/125mL E 20171231 58088-001_c31e0961-9d66-45d9-bd5e-2b37d078c8e3 58088-001 HUMAN OTC DRUG Canova Immune Support Canova Immune Support LIQUID ORAL 20130506 UNAPPROVED HOMEOPATHIC MRL Homeopathic USA LLC ACONITUM NAPELLUS; APIS MELLIFERA; ARSENIC TRIOXIDE; ASAFETIDA; BARIUM CARBONATE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; IPECAC; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; CASTOR OIL; SILICON DIOXIDE; THUJA OCCIDENTALIS ROOT; VERATRUM ALBUM ROOT 20; 19; 17; 20; 20; 14; 20; 16; 13; 18; 20; 13; 17; 14; 18; 16; 20 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL E 20171231 58092-001_a47683ea-aa14-433c-bb8f-3aa808595645 58092-001 HUMAN OTC DRUG DrxNoze Nosebleed Relief Achillea Millefolium, Marrubium Vulgare, Stachys Betonica, Urtica Dioica SWAB NASAL 20140201 UNAPPROVED HOMEOPATHIC ByzMed, LLC ACHILLEA MILLEFOLIUM; MARRUBIUM VULGARE; STACHYS OFFICINALIS; URTICA DIOICA 1; 1; 1; 1 [hp_X]/1.5mL; [hp_X]/1.5mL; [hp_X]/1.5mL; [hp_X]/1.5mL E 20171231 58095-0001_69e8c1b6-3577-4870-859c-37d29b39bc52 58095-0001 HUMAN OTC DRUG HGH PLUS Arnica Montana, Deer Antler Velvet, Hepar Bovine, HGH, IGF-1, Pituitaria Glandula Bovine, Thuja Occidentalis LIQUID ORAL 20131004 UNAPPROVED HOMEOPATHIC Solutions 4 Health ARNICA MONTANA; CERVUS NIPPON VELVET; BEEF LIVER; SOMATROPIN; MECASERMIN; BOS TAURUS PITUITARY GLAND; THUJA OCCIDENTALIS LEAF 6; 8; 6; 24; 8; 5; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 58118-0005_5a80b79f-d844-b186-e053-2991aa0a0ce6 58118-0005 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Clinical Solutions Wholesale SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 58118-0006_5a80b79f-d844-b186-e053-2991aa0a0ce6 58118-0006 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Clinical Solutions Wholesale SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 58118-0014_5cf0dfbc-242a-4812-e053-2991aa0aaea4 58118-0014 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 20180801 ANDA ANDA074052 Clinical Solutions Wholesale, LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 58118-0023_5aa579f9-e4c0-d251-e053-2991aa0a28d2 58118-0023 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Clinical Solutions Wholesale, LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0025_5a5e013d-b78d-9ede-e053-2991aa0a1cb4 58118-0025 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA087479 Clinical Solutions Wholsesale HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 58118-0027_5a8039ee-2bb1-0be3-e053-2a91aa0a939d 58118-0027 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 Clinical Solutions Wholesale, LLC PREDNISONE 20 mg/1 N 20181231 58118-0030_5a80b79f-d889-b186-e053-2991aa0a0ce6 58118-0030 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 Clinical Solutions Wholesale, LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 58118-0032_5bec9ccf-470c-50d3-e053-2991aa0a1155 58118-0032 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Clinical Solutions Wholesale, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0033_5aa64d1c-3ab4-0016-e053-2a91aa0a2444 58118-0033 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150316 ANDA ANDA040616 Clinical Solutions Wholesale, LLC WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 58118-0034_5ad351a9-fe6d-a78b-e053-2991aa0aa6cc 58118-0034 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Clinical Solutions Wholesale, LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 58118-0035_5cf0dfbc-242a-4812-e053-2991aa0aaea4 58118-0035 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 20180801 ANDA ANDA073025 Clinical Solutions Wholesale, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 58118-0040_5a6907d7-be69-1fa1-e053-2991aa0ad77b 58118-0040 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Clinical Solutions Wholesale, LLC DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 58118-0041_5aa64d1c-3ab4-0016-e053-2a91aa0a2444 58118-0041 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150316 ANDA ANDA040616 Clinical Solutions Wholesale, LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 58118-0042_5a6907d7-be69-1fa1-e053-2991aa0ad77b 58118-0042 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Clinical Solutions Wholesale, LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 58118-0043_5a56cb95-2086-3a96-e053-2a91aa0a016d 58118-0043 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20140131 ANDA ANDA090168 Clinical Solutions Wholesale, LLC BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 58118-0051_5cefe782-8fe7-69bc-e053-2a91aa0a3b24 58118-0051 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 20180501 ANDA ANDA070033 Clinical Solutions Wholesale, LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 58118-0052_5be899fc-132a-349e-e053-2991aa0adc4e 58118-0052 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Clinical Solutions Wholesale, LLC MIRTAZAPINE 15 mg/1 N 20181231 58118-0053_5a6907d7-bcb8-1fa1-e053-2991aa0ad77b 58118-0053 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Clinical Solutions Wholesale, LLC OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 58118-0060_5aa64d1c-3ab4-0016-e053-2a91aa0a2444 58118-0060 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150316 ANDA ANDA040616 Clinical Solutions Wholesale, LLC WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 58118-0062_5bed1969-1c87-87a8-e053-2991aa0a1a6c 58118-0062 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20101020 ANDA ANDA074584 Clinical Solutions Wholesale, LLC BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 58118-0063_5aa64d1c-3ab4-0016-e053-2a91aa0a2444 58118-0063 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150316 ANDA ANDA040616 Clinical Solutions Wholesale, LLC WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 58118-0064_5aa64d1c-3ab4-0016-e053-2a91aa0a2444 58118-0064 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150316 ANDA ANDA040616 Clinical Solutions Wholesale, LLC WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 58118-0071_5a5e013d-b7a2-9ede-e053-2991aa0a1cb4 58118-0071 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 Clinical Solutions Wholesale ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 58118-0072_5a5e013d-b6f8-9ede-e053-2991aa0a1cb4 58118-0072 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Clinical Solutions Wholesale, LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 58118-0073_5a5e013d-b6f8-9ede-e053-2991aa0a1cb4 58118-0073 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Clinical Solutions Wholesale, LLC CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 58118-0074_5aa52c22-f698-421c-e053-2991aa0aaf46 58118-0074 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Clinical Solutions Wholesale, LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 58118-0075_5a6a9dac-0439-cdb5-e053-2991aa0a5a7f 58118-0075 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071219 ANDA ANDA077056 Clinical Solutions Wholesale, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 58118-0076_5cee1f79-2a7b-f31e-e053-2a91aa0adfc8 58118-0076 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 20180501 ANDA ANDA090858 Clinical Solutions Wholesale, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58118-0077_5a80b79f-d7ee-b186-e053-2991aa0a0ce6 58118-0077 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Clinical Solutions Wholesale, LLC RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 58118-0078_5a80b79f-d7ee-b186-e053-2991aa0a0ce6 58118-0078 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Clinical Solutions Wholesale, LLC RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 58118-0080_5a80b79f-d7ee-b186-e053-2991aa0a0ce6 58118-0080 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Clinical Solutions Wholesale, LLC RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 58118-0081_5a80b79f-d7ee-b186-e053-2991aa0a0ce6 58118-0081 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Clinical Solutions Wholesale, LLC RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 58118-0082_5cee5f96-293f-3201-e053-2a91aa0a9561 58118-0082 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 20180301 ANDA ANDA078384 Clinical Solutions Wholesale, LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 58118-0083_5cee5f96-293f-3201-e053-2a91aa0a9561 58118-0083 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 20180301 ANDA ANDA078384 Clinical Solutions Wholesale, LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 58118-0084_5cee5f96-293f-3201-e053-2a91aa0a9561 58118-0084 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 20180301 ANDA ANDA078384 Clinical Solutions Wholesale, LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 58118-0085_5cee5f96-293f-3201-e053-2a91aa0a9561 58118-0085 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 20180301 ANDA ANDA078384 Clinical Solutions Wholesale, LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 58118-0095_5aa4f1c7-3b61-0f62-e053-2991aa0a094e 58118-0095 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Clinical Solutions Wholesale, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0096_5aa4f1c7-3b61-0f62-e053-2991aa0a094e 58118-0096 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Clinical Solutions Wholesale, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0097_5aa4f1c7-3b61-0f62-e053-2991aa0a094e 58118-0097 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Clinical Solutions Wholesale, LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0102_5a6a0f7b-4a6c-0e5f-e053-2991aa0a09a0 58118-0102 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Clinical Solutions Wholesale METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 58118-0112_5a5d62f7-368e-1e46-e053-2a91aa0a5ee8 58118-0112 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Clinical Solutions Wholesale, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0122_5a56da92-d9b5-3362-e053-2991aa0a8d32 58118-0122 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20100315 ANDA ANDA090510 Clinical Solutions Wholesale, LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 58118-0123_5a56da92-d98f-3362-e053-2991aa0a8d32 58118-0123 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20090702 ANDA ANDA040907 Clinical Solutions Wholesale, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 58118-0127_5a5dd2fe-a253-8c02-e053-2991aa0aff82 58118-0127 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Clinical Solutions Wholesale CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 58118-0135_5b48f8c9-4760-fed6-e053-2991aa0af794 58118-0135 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20170706 ANDA ANDA200958 Clinical Solutions Wholesale, LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 58118-0136_5a5d72ce-eefa-05b7-e053-2a91aa0a3573 58118-0136 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20170912 ANDA ANDA090168 Clinical Solutions Wholesale, LLC BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 58118-0137_5a547fc3-e0fa-2d1a-e053-2a91aa0ace8b 58118-0137 HUMAN PRESCRIPTION DRUG Folic Acid FOLIC ACID TABLET ORAL 20090112 ANDA ANDA040796 Clinical Solutions Wholesale, LLC FOLIC ACID 1 mg/1 N 20181231 58118-0138_5a5d62f7-3651-1e46-e053-2a91aa0a5ee8 58118-0138 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20170831 ANDA ANDA090168 Clinical Solutions Wholesale, LLC BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 58118-0143_5a54dca4-bf0d-8cf3-e053-2991aa0afb17 58118-0143 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Clinical Solutions Wholesale, LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 58118-0144_5a54dca4-bf0d-8cf3-e053-2991aa0afb17 58118-0144 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Clinical Solutions Wholesale, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 58118-0150_5ae1096e-e9b4-dc0e-e053-2991aa0a50dc 58118-0150 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Clinical Solutions Wholesale, LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 58118-0155_5640e95a-be58-403d-e054-00144ff88e88 58118-0155 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 20180601 ANDA ANDA078406 Clinical Solutions Wholesale PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0158_5a6a9dac-03ea-cdb5-e053-2991aa0a5a7f 58118-0158 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Clinical Solutions Wholesale OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 58118-0160_5bec433b-40f9-6787-e053-2a91aa0acfd3 58118-0160 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20101117 ANDA ANDA091630 Clinical Solutions Wholesale, LLC TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 58118-0161_5bec433b-40f9-6787-e053-2a91aa0acfd3 58118-0161 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20101117 ANDA ANDA091630 Clinical Solutions Wholesale, LLC TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 N 20181231 58118-0162_5a555912-6afe-12eb-e053-2a91aa0aecde 58118-0162 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Clinical Solutions Wholesale CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 58118-0163_5a555912-6afe-12eb-e053-2a91aa0aecde 58118-0163 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Clinical Solutions Wholesale CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 58118-0164_5a555912-6afe-12eb-e053-2a91aa0aecde 58118-0164 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Clinical Solutions Wholesale CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 58118-0165_5a555912-6afe-12eb-e053-2a91aa0aecde 58118-0165 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Clinical Solutions Wholesale CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 58118-0174_5be942e7-bc45-1472-e053-2a91aa0ad5c6 58118-0174 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Clinical Solutions Wholesale, LLC CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 58118-0180_1843fe38-ca84-4165-9d07-1a6d50eb1d46 58118-0180 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20020627 ANDA ANDA076280 Clinical Solutions Wholesale TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 58118-0183_5a6a9dac-0476-cdb5-e053-2991aa0a5a7f 58118-0183 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Clinical Solutions Wholesale, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0184_5a6a9dac-0476-cdb5-e053-2991aa0a5a7f 58118-0184 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Clinical Solutions Wholesale, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0191_64912546-ccfc-055d-e053-2a91aa0a8c30 58118-0191 HUMAN PRESCRIPTION DRUG bupropion Hydrochloride bupropion Hydrochloride TABLET ORAL 20160819 ANDA ANDA206975 Clinical Solutions Wholesale, LLC BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 58118-0196_5cf0c7dc-2348-118b-e053-2a91aa0a32fa 58118-0196 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 20180501 ANDA ANDA077987 Clinical Solutions Wholesale, LLC. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 58118-0199_5a6a73ea-0c3f-ad09-e053-2a91aa0aef77 58118-0199 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Clinical Solutions Wholesale, LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 58118-0226_5cee8a9a-b14b-c068-e053-2991aa0a7d41 58118-0226 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 20180801 ANDA ANDA090858 Clinical Solutions Wholesale, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58118-0227_5beb5992-d270-cc9f-e053-2991aa0a7393 58118-0227 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxycycline hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 Clinical Solutions Wholesale, LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 58118-0244_5a6a0f7b-4a18-0e5f-e053-2991aa0a09a0 58118-0244 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Clinical Solutions Wholesale, LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 58118-0245_5a6a0f7b-4a18-0e5f-e053-2991aa0a09a0 58118-0245 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Clinical Solutions Wholesale, LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 58118-0268_5a5d62f7-3660-1e46-e053-2a91aa0a5ee8 58118-0268 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20091023 ANDA ANDA077272 Clinical Solutions Wholesale CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 58118-0289_642d64dd-c25b-6fed-e053-2991aa0afe43 58118-0289 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20180201 ANDA ANDA076890 Clinical Solutions Wholesale, LLC LEVOFLOXACIN 500 mg/1 N 20191231 58118-0305_5b487692-b6a4-0999-e053-2a91aa0a98e0 58118-0305 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Clinical Solutions Wholesale, LLC INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 58118-0342_52a2c197-c2f7-024f-e054-00144ff88e88 58118-0342 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 20180301 ANDA ANDA090527 Clinical Solutions Wholesale HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 58118-0343_52a2c197-c2f7-024f-e054-00144ff88e88 58118-0343 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 20180401 ANDA ANDA090527 Clinical Solutions Wholesale HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 58118-0345_5a80b79f-d986-b186-e053-2991aa0a0ce6 58118-0345 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 Clinical Solutions Wholesale VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 58118-0357_5a697b85-6855-07ee-e053-2a91aa0a5a6f 58118-0357 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 Clinical Solutions Wholesale CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 58118-0360_5bd77879-0de5-14e1-e053-2991aa0a2611 58118-0360 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA074644 Clinical Solutions Wholesale, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 58118-0361_5bd77879-0de5-14e1-e053-2991aa0a2611 58118-0361 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA076670 Clinical Solutions Wholesale, LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 58118-0364_5beccb56-d361-1371-e053-2991aa0ac4a5 58118-0364 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20160629 ANDA ANDA072204 Clinical Solutions Wholesale, LLC LOXAPINE SUCCINATE 5 mg/1 N 20181231 58118-0383_5bec20cd-5446-c795-e053-2a91aa0a090c 58118-0383 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Clinical Solutions Wholesale, LLC TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 58118-0384_5bec20cd-5446-c795-e053-2a91aa0a090c 58118-0384 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Clinical Solutions Wholesale, LLC TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 58118-0396_5ebd36b7-043c-7ab6-e053-2991aa0a4fe1 58118-0396 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20170927 ANDA ANDA071209 Clinical Solutions Wholesale, LLC HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 58118-0397_5ebd36b7-043c-7ab6-e053-2991aa0a4fe1 58118-0397 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20170927 ANDA ANDA071210 Clinical Solutions Wholesale, LLC HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] N 20181231 58118-0413_5be8f606-7375-34d3-e053-2a91aa0a731a 58118-0413 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Clinical Solutions Wholesale, LLC CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 58118-0420_5a555912-6b4d-12eb-e053-2a91aa0aecde 58118-0420 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Clinical Solutions Wholesale SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 58118-0429_5a80b79f-d8bc-b186-e053-2991aa0a0ce6 58118-0429 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Clinical Solutions Wholesale, LLC TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 58118-0430_5a80b79f-d8bc-b186-e053-2991aa0a0ce6 58118-0430 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 Clinical Solutions Wholesale, LLC TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 58118-0431_5a80b79f-d8bc-b186-e053-2991aa0a0ce6 58118-0431 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Clinical Solutions Wholesale, LLC TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 58118-0450_5becd0eb-8a10-2245-e053-2a91aa0a9339 58118-0450 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Clinical Solutions Wholesale, LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 58118-0468_5bebea3f-8916-41d5-e053-2991aa0a81c7 58118-0468 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070612 ANDA ANDA078103 Clinical Solutions Wholesale, LLC SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 58118-0484_5a6a55e2-b9f9-6f8b-e053-2991aa0a4154 58118-0484 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20150402 ANDA ANDA065062 Clinical Solutions Wholesale, LLC MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 58118-0486_5a6a9dac-050c-cdb5-e053-2991aa0a5a7f 58118-0486 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170727 ANDA ANDA077917 Clinical Solutions Wholesale, LLC PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 58118-0527_5a6907d7-bf64-1fa1-e053-2991aa0ad77b 58118-0527 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 Clinical Solutions Wholesale, LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 58118-0541_5beae2b4-8aba-be56-e053-2a91aa0acd5a 58118-0541 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20100218 ANDA ANDA078218 Clinical Solutions Wholesale CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 58118-0542_5b48c63b-a4bb-7c36-e053-2a91aa0a843a 58118-0542 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 Clinical Solutions Wholesale, LLC INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 58118-0545_5bebd055-7da5-2ad2-e053-2991aa0a7572 58118-0545 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 Clinical Solutions Wholesale LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 58118-0615_5a5e013d-b78d-9ede-e053-2991aa0a1cb4 58118-0615 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 Clinical Solutions Wholsesale HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 58118-0630_5a5e013d-b7de-9ede-e053-2991aa0a1cb4 58118-0630 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Clinical Solutions Wholesale, LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 58118-0631_5a5e013d-b7de-9ede-e053-2991aa0a1cb4 58118-0631 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Clinical Solutions Wholesale, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 58118-0632_5beb440f-6667-d2d2-e053-2a91aa0a6e12 58118-0632 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Clinical Solutions Wholesale FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0633_5a5e013d-b7de-9ede-e053-2991aa0a1cb4 58118-0633 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 20180501 ANDA ANDA077321 Clinical Solutions Wholesale, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 58118-0634_5a5e013d-b7de-9ede-e053-2991aa0a1cb4 58118-0634 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 20180501 ANDA ANDA077321 Clinical Solutions Wholesale, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 58118-0635_5a5e013d-b7de-9ede-e053-2991aa0a1cb4 58118-0635 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Clinical Solutions Wholesale, LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 58118-0644_5a5e013d-b715-9ede-e053-2991aa0a1cb4 58118-0644 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Clinical Solutions Wholesale, LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0645_5a5e013d-b715-9ede-e053-2991aa0a1cb4 58118-0645 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Clinical Solutions Wholesale, LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0692_5a5e013d-b6de-9ede-e053-2991aa0a1cb4 58118-0692 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Clinical Solutions Wholesale CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 58118-0693_5a5e013d-b6de-9ede-e053-2991aa0a1cb4 58118-0693 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Clinical Solutions Wholesale CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 58118-0795_5a6907d7-be35-1fa1-e053-2991aa0ad77b 58118-0795 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 Clinical Solutions Wholesale DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 58118-0803_649281d8-ea4d-3ca2-e053-2991aa0af6f7 58118-0803 HUMAN PRESCRIPTION DRUG Ranitidine Immediate release Ranitidine TABLET ORAL 20160829 ANDA ANDA205512 Clinical Solutions Wholesale, LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 58118-0812_5a6907d7-beb1-1fa1-e053-2991aa0ad77b 58118-0812 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20170727 ANDA ANDA090705 Clinical Solutions Wholesale, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58118-0814_5a6907d7-beb1-1fa1-e053-2991aa0ad77b 58118-0814 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20170727 ANDA ANDA090705 Clinical Solutions Wholesale, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58118-0821_5beba486-b8d1-6969-e053-2991aa0aa5b1 58118-0821 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20160708 ANDA ANDA077836 Clinical Solutions Wholesale, LLC GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 58118-0833_5a8028dd-16bf-3084-e053-2991aa0ab8ec 58118-0833 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Clinical Solutions Wholesale, LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0834_5a8028dd-16bf-3084-e053-2991aa0ab8ec 58118-0834 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Clinical Solutions Wholesale, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0835_5a8028dd-16bf-3084-e053-2991aa0ab8ec 58118-0835 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Clinical Solutions Wholesale, LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-0837_5a563e50-3012-19e2-e053-2991aa0a7214 58118-0837 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160701 ANDA ANDA077955 Clinical Solutions Wholesale, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 58118-0838_5a563e50-3012-19e2-e053-2991aa0a7214 58118-0838 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160701 ANDA ANDA077955 Clinical Solutions Wholesale, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 58118-0855_5cf09d1c-ea6b-07ad-e053-2a91aa0a9bd4 58118-0855 HUMAN PRESCRIPTION DRUG naproxen naproxen TABLET ORAL 20160705 20180701 ANDA ANDA091305 Clinical Solutions Wholesale, LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 58118-0859_5aa66515-b058-3f92-e053-2a91aa0a97f2 58118-0859 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20170706 ANDA ANDA206530 Clinical Solutions Wholesale, LLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 58118-0878_6490dc39-f2bc-0bc5-e053-2a91aa0a9249 58118-0878 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE (SR) Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20180206 ANDA ANDA206674 Clinical Solutions Wholesale, LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 58118-0924_5a6a0f7b-4a50-0e5f-e053-2991aa0a09a0 58118-0924 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Clinical Solutions Wholesale, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 58118-1002_5a5e013d-b777-9ede-e053-2991aa0a1cb4 58118-1002 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Clinical Solutions Wholesale, LLC HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 58118-1003_5a5e013d-b777-9ede-e053-2991aa0a1cb4 58118-1003 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Clinical Solutions Wholesale, LLC HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 58118-1011_5cde5163-cf7d-728a-e053-2a91aa0aa53b 58118-1011 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20171031 ANDA ANDA078932 Clinical Solutions Wholesale, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58118-1112_642dcd86-f4a5-0686-e053-2a91aa0aa060 58118-1112 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20180201 ANDA ANDA078154 Clinical Solutions Wholesale, LLC LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 58118-1127_5b4836b5-ea83-51ca-e053-2a91aa0a676f 58118-1127 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20171011 ANDA ANDA077073 Clinical Solutions Wholesale, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 58118-1128_5b4836b5-ea83-51ca-e053-2a91aa0a676f 58118-1128 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20171011 ANDA ANDA077073 Clinical Solutions Wholesale, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 58118-1148_5b4adccb-752c-7e36-e053-2a91aa0aa48e 58118-1148 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20171011 ANDA ANDA202152 Clinical Solutions Wholesale, LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 58118-1210_5a6a9dac-03a5-cdb5-e053-2991aa0a5a7f 58118-1210 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Clinical Solutions Wholesale, LLC PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 58118-1248_5a6907d7-bdd1-1fa1-e053-2991aa0ad77b 58118-1248 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Clinical Solutions Wholesale MIRTAZAPINE 30 mg/1 N 20181231 58118-1249_5a6907d7-bdd1-1fa1-e053-2991aa0ad77b 58118-1249 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Clinical Solutions Wholesale MIRTAZAPINE 45 mg/1 N 20181231 58118-1271_5a5d62f7-3660-1e46-e053-2a91aa0a5ee8 58118-1271 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET, CHEWABLE ORAL 20090826 ANDA ANDA075712 Clinical Solutions Wholesale CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 58118-1334_5a80b79f-d9ab-b186-e053-2991aa0a0ce6 58118-1334 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale, LLC LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1341_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1341 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1342_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1342 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1343_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1343 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1344_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1344 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1345_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1345 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1346_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1346 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1347_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1347 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1349_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1349 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1351_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1351 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1391_490e6b83-1590-6829-e054-00144ff88e88 58118-1391 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071206 Clinical Solutions Wholesale HALOPERIDOL .5 mg/1 Typical Antipsychotic [EPC] N 20181231 58118-1392_490e6b83-1590-6829-e054-00144ff88e88 58118-1392 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071207 Clinical Solutions Wholesale HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] N 20181231 58118-1393_490e6b83-1590-6829-e054-00144ff88e88 58118-1393 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071208 Clinical Solutions Wholesale HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] N 20181231 58118-1396_490e6b83-1590-6829-e054-00144ff88e88 58118-1396 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071209 Clinical Solutions Wholesale HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 58118-1397_490e6b83-1590-6829-e054-00144ff88e88 58118-1397 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19880311 ANDA ANDA071210 Clinical Solutions Wholesale HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] N 20181231 58118-1402_5a6907d7-bd6c-1fa1-e053-2991aa0ad77b 58118-1402 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20061212 ANDA ANDA040621 Clinical Solutions Wholesale PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 58118-1429_62fd2180-8dc1-eb19-e053-2a91aa0a6f5a 58118-1429 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20180117 ANDA ANDA090074 Clinical Solutions Wholesale, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 58118-1443_5bfebda6-f34c-aa10-e053-2991aa0af3fd 58118-1443 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 ANDA ANDA021210 Clinical Solutions Wholesale, LLC LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1444_5bfebda6-f34c-aa10-e053-2991aa0af3fd 58118-1444 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 ANDA ANDA021210 Clinical Solutions Wholesale, LLC LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1451_5a6907d7-beec-1fa1-e053-2991aa0ad77b 58118-1451 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Clinical Solutions Wholesale, LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 58118-1453_5a6907d7-beec-1fa1-e053-2991aa0ad77b 58118-1453 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Clinical Solutions Wholesale, LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 58118-1526_5aa5b4c8-f91b-0df4-e053-2991aa0ada94 58118-1526 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Clinical Solutions Wholesale POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 58118-1638_6a3aa7ea-4a9d-4be2-a6d9-5fbf21673835 58118-1638 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Clinical Solutions Wholesale LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 58118-1715_5bec9e6f-9e2a-6144-e053-2a91aa0a0bab 58118-1715 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150714 ANDA ANDA040616 Clinical Solutions Wholesale, LLC WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 58118-1820_5aa52c22-f698-421c-e053-2991aa0aaf46 58118-1820 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Clinical Solutions Wholesale, LLC BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 58118-1980_5a67dea4-03b2-7f70-e053-2991aa0a0351 58118-1980 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170307 ANDA ANDA077321 Clinical Solutions Wholesale, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 58118-1981_5a67dea4-03b2-7f70-e053-2991aa0a0351 58118-1981 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170307 ANDA ANDA077321 Clinical Solutions Wholesale, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 58118-2022_5a5d62f7-361a-1e46-e053-2a91aa0a5ee8 58118-2022 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20170811 ANDA ANDA076900 Clinical Solutions Wholesale, LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 58118-2023_5a5d62f7-361a-1e46-e053-2a91aa0a5ee8 58118-2023 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20170811 ANDA ANDA076900 Clinical Solutions Wholesale, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 58118-2081_5be903b0-597a-4cd6-e053-2a91aa0aae69 58118-2081 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20120314 NDA AUTHORIZED GENERIC NDA021160 Clinical Solutions Wholesale CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 58118-2148_6492892f-2c12-6ee9-e053-2a91aa0adb20 58118-2148 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Clinical Solutions Wholesale, LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 58118-2435_5cee4385-7348-2290-e053-2a91aa0ad2eb 58118-2435 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 20180708 ANDA ANDA040715 Clinical Solutions Wholesale BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 58118-2528_5a6907d7-bd83-1fa1-e053-2991aa0ad77b 58118-2528 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Clinical Solutions Wholesale ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 58118-2529_5a6907d7-bd83-1fa1-e053-2991aa0ad77b 58118-2529 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Clinical Solutions Wholesale ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 58118-2530_5a6907d7-bd83-1fa1-e053-2991aa0ad77b 58118-2530 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Clinical Solutions Wholesale ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 58118-2531_5a6907d7-bd83-1fa1-e053-2991aa0ad77b 58118-2531 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Clinical Solutions Wholesale ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 58118-2578_5812e7e1-0084-0034-e053-2991aa0abf33 58118-2578 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Clinical Solutions Wholesale, LLC ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 58118-2579_5812e7e1-0084-0034-e053-2991aa0abf33 58118-2579 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Clinical Solutions Wholesale, LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 58118-2678_5ad2ceea-6b79-4a8e-e053-2991aa0a6737 58118-2678 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20171005 ANDA ANDA090548 Clinical Solutions Wholesale, LLC ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 58118-2679_5ad2ceea-6b79-4a8e-e053-2991aa0a6737 58118-2679 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20171005 ANDA ANDA090548 Clinical Solutions Wholesale, LLC ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 58118-4001_5a552159-b225-4ae6-e053-2991aa0a6a52 58118-4001 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Clinical Solutions Wholesale, LLC NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 58118-4002_5a552159-b225-4ae6-e053-2991aa0a6a52 58118-4002 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Clinical Solutions Wholesale, LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 58118-4003_5a552159-b225-4ae6-e053-2991aa0a6a52 58118-4003 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Clinical Solutions Wholesale, LLC NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 58118-4012_5a80b79f-d8f5-b186-e053-2991aa0a0ce6 58118-4012 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 20090908 ANDA ANDA073229 Clinical Solutions Wholesale VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 58118-4101_5cc8b5f1-4ab3-471b-e053-2991aa0a84c1 58118-4101 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20171030 ANDA ANDA207582 Clinical Solutions Wholesale, LLC PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 58118-4102_5cc8b5f1-4ab3-471b-e053-2991aa0a84c1 58118-4102 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20171030 ANDA ANDA207582 Clinical Solutions Wholesale, LLC PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 58118-4103_5cc8b5f1-4ab3-471b-e053-2991aa0a84c1 58118-4103 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20171030 ANDA ANDA207582 Clinical Solutions Wholesale, LLC PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 58118-4104_5cc8b5f1-4ab3-471b-e053-2991aa0a84c1 58118-4104 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20171030 ANDA ANDA207582 Clinical Solutions Wholesale, LLC PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 58118-5060_5a6a55e2-ba13-6f8b-e053-2991aa0a4154 58118-5060 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Clinical Solutions Wholesale PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 58118-5061_5a6a55e2-ba13-6f8b-e053-2991aa0a4154 58118-5061 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Clinical Solutions Wholesale PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 58118-5062_5a6a55e2-ba13-6f8b-e053-2991aa0a4154 58118-5062 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Clinical Solutions Wholesale PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 58118-5063_5a6a55e2-ba13-6f8b-e053-2991aa0a4154 58118-5063 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Clinical Solutions Wholesale PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 58118-5135_17079b90-ccb2-4f35-8641-fdf3613d834f 58118-5135 HUMAN OTC DRUG Pain Reliever Plus Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Clinical Solutions Wholesale ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 58118-5307_5ae32609-e374-273e-e053-2a91aa0a818a 58118-5307 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 Clinical Solutions Wholesale PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 58118-5442_5a8028dd-16a3-3084-e053-2991aa0ab8ec 58118-5442 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA085162 Clinical Solutions Wholesale, LLC PREDNISONE 10 mg/1 N 20181231 58118-6074_6491ad51-ca8b-8d6b-e053-2a91aa0ae2df 58118-6074 HUMAN PRESCRIPTION DRUG Fluphenazine hydrochloride Fluphenazine hydrochloride TABLET, FILM COATED ORAL 19880812 ANDA ANDA089804 Clinical Solutions Wholesale, LLC FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 58118-6113_5a6907d7-bf25-1fa1-e053-2991aa0ad77b 58118-6113 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Clinical Solutions Wholesale, LLC LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58118-6114_5a6907d7-bf25-1fa1-e053-2991aa0ad77b 58118-6114 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Clinical Solutions Wholesale, LLC LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58118-6115_5a6907d7-bf25-1fa1-e053-2991aa0ad77b 58118-6115 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA090025 Clinical Solutions Wholesale, LLC LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58118-6771_5bec10e3-f5d0-3aa0-e053-2a91aa0abdec 58118-6771 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Clinical Solutions Wholesale, LLC OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 58118-7927_f97e277d-2fb1-4fad-845a-a1d5541dad73 58118-7927 HUMAN OTC DRUG Bisacodyl Enteric Coated Bisacodyl TABLET, COATED ORAL 20081024 OTC MONOGRAPH NOT FINAL part334 Clinical Solutions Wholesale BISACODYL 5 mg/1 N 20181231 58118-8344_5bd7b270-31cc-5bff-e053-2a91aa0aec99 58118-8344 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Clinical Solutions Wholesale GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 58118-8943_5a5cfa30-56fb-571d-e053-2a91aa0a3d0e 58118-8943 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 Clinical Solutions Wholesale ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 58118-9842_0d026350-1c4e-4377-b24e-b586cbc794e5 58118-9842 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 19971020 ANDA ANDA074612 Clinical Solutions Wholesale NICOTINE 21 mg/24h N 20181231 58118-9896_73f68f97-ad3a-492b-a96d-304b464ffd03 58118-9896 HUMAN OTC DRUG MUCUS RELIEF GUAIFENESIN TABLET ORAL 20120723 OTC MONOGRAPH FINAL part341 Clinical Solutions Wholesale GUAIFENESIN 400 mg/1 N 20181231 58120-001_12f5a913-ffd6-49a1-a344-f6806044d68d 58120-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800101 UNAPPROVED MEDICAL GAS Home Care Medical, Inc OXYGEN 990 mL/L E 20171231 58125-0001_61ddf592-1b37-4c28-b753-65f8a958d534 58125-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19940526 UNAPPROVED MEDICAL GAS Resp-I-Care, Inc. OXYGEN 99 L/100L E 20171231 58128-0001_cbb67ed3-0e26-491c-8e69-210d04b73380 58128-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900504 UNAPPROVED MEDICAL GAS Family Medical Supply Inc. OXYGEN 99 L/100L E 20171231 58132-3331_c2b362c3-36dc-40ef-91be-242d45a09b47 58132-3331 HUMAN OTC DRUG Alcis Daily Relief Pain Relief Trolamine Salicylate CREAM TOPICAL 20090309 OTC MONOGRAPH NOT FINAL part348 Alcis Topical, Inc. TROLAMINE SALICYLATE 10 g/100mL N 20181231 58133-001_2f35d74d-d185-43b3-841e-6eaeef127ff9 58133-001 HUMAN OTC DRUG Marathon Pain Relief Topical Analgesic Menthol 3.0% LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty labs, Inc. MENTHOL 3 g/100g N 20181231 58133-049_20453893-3b4e-4eb5-9d1b-e2afef350940 58133-049 HUMAN OTC DRUG Miracle Pain Cream Menthol CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty labs, Inc. MENTHOL 3 g/100g N 20181231 58133-055_1d8d9dbb-4554-49ea-98ea-d63e508f34fd 58133-055 HUMAN OTC DRUG BerbereX Wound Cleanser Allantoin, Benzethonium Chloride SOLUTION TOPICAL 20130915 OTC MONOGRAPH NOT FINAL part333A Cosmetic Specialty Labs, Inc. ALLANTOIN; BENZETHONIUM CHLORIDE 5; 1 g/1000mL; g/1000mL N 20181231 58133-062_ff70bbb4-b434-483f-a510-3b811a1b331b 58133-062 HUMAN OTC DRUG LEROSETT High-Content Organic Acne Treatment Botanically Based Salicylic Acid GEL TOPICAL 20130101 OTC MONOGRAPH FINAL part333D Cosmetic Specialty labs, Inc. SALICYLIC ACID 2 g/100mL N 20181231 58133-075_5ef26b5b-5f72-4f45-8d89-8d40b704a38a 58133-075 HUMAN OTC DRUG Red Lion Relief Menthol CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty labs, Inc. MENTHOL 3 g/100g E 20171231 58133-100_624ae049-7879-3713-e053-2991aa0a07bf 58133-100 HUMAN OTC DRUG Real Time Pain Relief MAXX Topical Analgesic Menthol 1.5% LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty Labs, Inc. MENTHOL 1.5 g/100mL N 20191231 58133-101_62d7422a-1d5b-164f-e053-2a91aa0acec7 58133-101 HUMAN OTC DRUG Real Time Pain Relief Hemp Oil Plus Arnica Montana CREAM TOPICAL 20150101 UNAPPROVED HOMEOPATHIC Cosmetic Specialty Labs, Inc. ARNICA MONTANA 3 [hp_X]/g N 20191231 58133-111_62478131-4ed8-5407-e053-2991aa0a5aac 58133-111 HUMAN OTC DRUG Homeopathic Lip Balm Arnica Montana OINTMENT TOPICAL 20150101 UNAPPROVED HOMEOPATHIC Cosmetic Specialty Labs, Inc. ARNICA MONTANA 2 [hp_X]/g N 20191231 58133-300_61e590d9-f6f5-bf71-e053-2991aa0a534d 58133-300 HUMAN OTC DRUG Real Time Pain Relief Daily Relief Arnica Montana (2X H.P.U.S.) LOTION TOPICAL 20140131 UNAPPROVED HOMEOPATHIC Cosmetic Specialty Labs, Inc. ARNICA MONTANA 2 mg/100mL N 20191231 58133-400_61e1af5e-d783-a3b6-e053-2a91aa0ad098 58133-400 HUMAN OTC DRUG Real Time Pain Relief Therapeutic Hand Cream Trolamine Salicylate 10% LOTION TOPICAL 20141216 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty Labs, Inc. TROLAMINE SALICYLATE 10 g/100mL N 20191231 58133-500_230eff3b-ad49-4729-8b6c-2bd56e15b61b 58133-500 HUMAN OTC DRUG Nuvileo Skin Perfecting Acne Salicylic Acid CREAM TOPICAL 20150630 OTC MONOGRAPH FINAL part333D Cosmetic Specialty Labs, Inc. SALICYLIC ACID 20 mg/mL N 20181231 58133-501_b7abc303-2b67-4eb3-8949-22dca4dad33a 58133-501 HUMAN OTC DRUG Nuvileo Acne Face Wash Salicylic Acid SOLUTION, GEL FORMING / DROPS TOPICAL 20150630 OTC MONOGRAPH FINAL part333D Cosmetic Specialty Labs, Inc. SALICYLIC ACID 20 mg/mL N 20181231 58133-555_62fb27de-beb5-8bed-e053-2991aa0a6ae1 58133-555 HUMAN OTC DRUG Real Time Pain Relief Vegan Select Menthol LOTION TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty Labs, Inc. MENTHOL 1.25 g/100mL N 20191231 58133-600_617d4c4c-c541-f7a3-e053-2991aa0afc0e 58133-600 HUMAN OTC DRUG Real Time Pain Relief Cream Menthol LOTION TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty Labs, Inc. MENTHOL 1.25 g/100mL N 20191231 58133-700_61d18e02-8b45-7c40-e053-2991aa0afbd2 58133-700 HUMAN OTC DRUG Real Time Pain Relief Sports Cream Topical Analgesic Menthol 0.5% LOTION TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty labs, Inc. MENTHOL .5 g/100mL N 20191231 58133-800_62d5d892-c014-7905-e053-2991aa0a9ba6 58133-800 HUMAN OTC DRUG Real Time Pain Relief Select Plus Hemp Oil Arnica Montana LOTION TOPICAL 20150101 UNAPPROVED HOMEOPATHIC Cosmetic Specialty Labs, Inc. ARNICA MONTANA 3 [hp_X]/mL N 20191231 58133-900_61e41c3f-b761-4b3d-e053-2991aa0a3248 58133-900 HUMAN OTC DRUG Real Time Pain Relief Foot Cream Topical Analgesic Menthol 1.5% CREAM TOPICAL 20130130 OTC MONOGRAPH NOT FINAL part348 Cosmetic Specialty labs, Inc. MENTHOL 1.5 g/100g N 20191231 58142-7115_f19fc070-34cd-4406-8a5c-ef569b40f580 58142-7115 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS St. John's Medical Supply OXYGEN 99 L/100L E 20171231 58154-100_97e6afc8-b5b0-452c-ba0c-3f64d167e216 58154-100 HUMAN OTC DRUG healthy mama SHAKE THAT ACHE ACETAMINOPHEN TABLET ORAL 20130418 OTC MONOGRAPH NOT FINAL part343 MATERNAL SCIENCE, LLC ACETAMINOPHEN 500 mg/1 E 20171231 58154-101_7ccb92e7-2d83-4019-a1f2-2c1e8dbf368d 58154-101 HUMAN OTC DRUG healthy mama MOVE IT ALONG DOCUSATE SODIUM TABLET, FILM COATED ORAL 20130423 OTC MONOGRAPH NOT FINAL part334 MATERNAL SCIENCE, LLC DOCUSATE SODIUM 100 mg/1 E 20171231 58154-103_a8d94f7e-d26d-4d69-a627-fe13cce0a295 58154-103 HUMAN OTC DRUG healthy mama TAME THE FLAME CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20130531 OTC MONOGRAPH FINAL part331 MATERNAL SCIENCE, LLC CALCIUM CARBONATE 500 mg/1 E 20171231 58154-104_cc2e8b60-ef3f-4c01-995f-5bc16d065432 58154-104 HUMAN OTC DRUG healthy mama eaZZZe THE PAIN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130429 OTC MONOGRAPH NOT FINAL part343 MATERNAL SCIENCE, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 58154-107_88b9de99-b1a3-41ae-b06c-65c819fa94bb 58154-107 HUMAN PRESCRIPTION DRUG healthy mamaBE WELL ROUNDED BE WELL ROUNDED .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS BISGLYCINATE, ZINC OXIDE, COPPER, CALCIUM PANTOTHENATE,MAGNESIUM OXIDE TABLET, FILM COATED ORAL 20130709 UNAPPROVED DRUG OTHER MATERNAL SCIENCE, LLC .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; METHYLCOBALAMIN; CALCIUM CARBONATE; FERROUS BISGLYCINATE; ZINC OXIDE; COPPER; BIOTIN; CALCIUM PANTOTHENATE; MAGNESIUM OXIDE 4000; 120; 400; 30; 1.8; 1.7; 20; 2.6; 800; 8; 200; 28; 25; 2; 30; 10; 30 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 58155-131_fbb6b0a8-4f9f-4dc4-a748-46943aa02807 58155-131 HUMAN OTC DRUG MoistureWorx White Petrolatum SPRAY TOPICAL 20130626 OTC MONOGRAPH FINAL part347 Juventio LLC PETROLATUM 36 g/120mL E 20171231 58160-810_8ea9e9fb-b379-4363-920d-ed68f0eec660 58160-810 VACCINE INFANRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed SUSPENSION INTRAMUSCULAR 20090724 BLA BLA103647 GlaxoSmithKline Biologicals SA CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 10; 25; 25; 25; 8 [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient] N 20181231 58160-811_1dea6337-2e26-4fc4-81ba-92957334e1b8 58160-811 VACCINE PEDIARIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined INJECTION, SUSPENSION INTRAMUSCULAR 20090724 BLA BLA103907 GlaxoSmithKline Biologicals SA CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 25; 10; 25; 25; 8; 10; 40; 8; 32 [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 58160-812_011d1383-fda3-4589-94c8-e892510f59dd 58160-812 VACCINE KINRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20080709 BLA BLA125260 GlaxoSmithKline Biologicals SA CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 25; 10; 25; 8; 25; 40; 8; 32 [iU]/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 58160-815_25b22899-5d47-410c-a575-eeb72e2e9497 58160-815 VACCINE TWINRIX Hepatitis A and Hepatitis B (Recombinant) Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20070607 BLA BLA103850 GlaxoSmithKline Biologicals SA HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 720; 20 [iU]/mL; ug/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20191231 58160-818_f7ebe494-1728-47db-b502-b088a8dc3113 58160-818 VACCINE Hiberix Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) KIT 20151221 BLA BLA125347 GlaxoSmithKline Biologicals SA N 20181231 58160-819_0280849d-5c78-4a9d-8941-4eab429f6bd8 58160-819 VACCINE Shingrix gE Recombinant Varicella Zoster Virus (VZV) glycoprotein E KIT 20171020 BLA BLA125614 GlaxoSmithKline Biologicals SA N 20181231 58160-820_bac87f9e-8514-477a-8c92-3a5ed504ddc5 58160-820 VACCINE ENGERIX-B Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR 20070425 BLA BLA103239 GlaxoSmithKline Biologicals SA HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 10 ug/.5mL N 20181231 58160-821_bac87f9e-8514-477a-8c92-3a5ed504ddc5 58160-821 VACCINE ENGERIX-B Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR 20070328 BLA BLA103239 GlaxoSmithKline Biologicals SA HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug/mL N 20181231 58160-823_0280849d-5c78-4a9d-8941-4eab429f6bd8 58160-823 VACCINE Shingrix gE Recombinant Varicella Zoster Virus (VZV) glycoprotein E KIT 20171020 BLA BLA125614 GlaxoSmithKline Biologicals SA N 20181231 58160-825_429b55b3-75e8-46f2-97e2-142f536e7391 58160-825 VACCINE HAVRIX Hepatitis A Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20070216 BLA BLA103475 GlaxoSmithKline Biologicals SA HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 720 [iU]/.5mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 58160-826_429b55b3-75e8-46f2-97e2-142f536e7391 58160-826 VACCINE HAVRIX Hepatitis A Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20070413 BLA BLA103475 GlaxoSmithKline Biologicals SA HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 1440 [iU]/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 58160-842_d2a9c6a6-4c35-4ba6-b36e-1bc1d2f28512 58160-842 VACCINE BOOSTRIX Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed SUSPENSION INTRAMUSCULAR 20090724 BLA BLA125106 GlaxoSmithKline Biologicals SA CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 5; 2.5; 8; 8; 2.5 [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient] N 20181231 58160-854_9c01a98c-e291-4470-9b5b-abde955d3286 58160-854 VACCINE ROTARIX Rotavirus Vaccine, Live, Oral KIT 20110113 BLA BLA125265 GlaxoSmithKline Biologicals SA N 20181231 58160-907_95e7bd29-1185-4602-9e3c-a41ab49d9638 58160-907 VACCINE FLUARIX QUADRIVALENT 2017/2018 influenza virus vaccine SUSPENSION INTRAMUSCULAR 20170707 20180630 BLA BLA125127 GlaxoSmithKline Biologicals SA INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL N 20191231 58160-955_d3112765-d061-4d4b-9444-b0e1f27e4e03 58160-955 VACCINE Menveo Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine KIT 20170301 BLA BLA125300 GlaxoSmithKline Biologicals SA N 20181231 58160-964_d9f547d3-c5a0-49e2-89d0-6ebe74e5723c 58160-964 VACCINE RabAvert Rabies Vaccine KIT 20161219 BLA BLA103334 GlaxoSmithKline Biologicals SA N 20181231 58160-976_a68650e0-73f3-406a-8d6f-563bebd0b8a1 58160-976 VACCINE Bexsero NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN and NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN INJECTION, SUSPENSION INTRAMUSCULAR 20161201 BLA BLA125546 GlaxoSmithKline Biologicals SA NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS SEROGROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE 50; 50; 50; 25 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL N 20181231 58161-155_5087f840-3789-4245-83cf-62aac3c7bf6d 58161-155 HUMAN OTC DRUG Dr.Phi Instant Hand Sanitizer Dr.Phi Instant Hand Sanitizer GEL TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A MAMIBA ALCOHOL .7 mL/mL E 20171231 58161-156_1f9c6906-6066-43b8-9db2-6cb7cf65975c 58161-156 HUMAN OTC DRUG Dr.Phi Advanced Hand sanitizer Dr.Phi advanced Hand Sanitizer GEL TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A MAMIBA ALCOHOL 70 mL/100mL N 20181231 58161-156_fe6a8eee-03e9-4372-817c-ebec598812af 58161-156 HUMAN OTC DRUG Dr.Phi Advanced Hand sanitizer Dr.Phi advanced Hand Sanitizer GEL TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A MAMIBA ALCOHOL 70 mL/100mL N 20181231 58162-100_5b805bf0-8293-4837-9896-effc251fd108 58162-100 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20130401 UNAPPROVED MEDICAL GAS Vagabond Welding Supply OXYGEN 99 L/100L E 20171231 58162-200_9210715d-21c1-433a-8582-765be4dd0d27 58162-200 HUMAN PRESCRIPTION DRUG AIR COMPRESSED MEDICAL AIR OXYGEN, NITROGEN GAS RESPIRATORY (INHALATION) 20130401 UNAPPROVED MEDICAL GAS Vagabond Welding Supply OXYGEN 21 L/100L E 20171231 58165-028_45bc21f6-150d-e5e0-4d8d-a00d890a161e 58165-028 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, COATED ORAL 20100608 ANDA ANDA077784 Ratiopharm Inc RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] E 20171231 58165-029_45bc21f6-150d-e5e0-4d8d-a00d890a161e 58165-029 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, COATED ORAL 20100608 ANDA ANDA077784 Ratiopharm Inc RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] E 20171231 58165-030_45bc21f6-150d-e5e0-4d8d-a00d890a161e 58165-030 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, COATED ORAL 20100608 ANDA ANDA077784 Ratiopharm Inc RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 58165-031_45bc21f6-150d-e5e0-4d8d-a00d890a161e 58165-031 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, COATED ORAL 20100608 ANDA ANDA077784 Ratiopharm Inc RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 58165-032_45bc21f6-150d-e5e0-4d8d-a00d890a161e 58165-032 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, COATED ORAL 20100608 ANDA ANDA077784 Ratiopharm Inc RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 58165-033_45bc21f6-150d-e5e0-4d8d-a00d890a161e 58165-033 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, COATED ORAL 20100608 ANDA ANDA077784 Ratiopharm Inc RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] E 20171231 58166-001_8a139a1c-8df1-4ceb-93c8-26480833b118 58166-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20130401 UNAPPROVED MEDICAL GAS Lynarc Welding Supplies & Material Inc. OXYGEN 99 L/100L E 20171231 58167-112_635414da-adef-4eac-be68-daf3f35f892e 58167-112 HUMAN OTC DRUG Mata Balm Camphor, Menthol OINTMENT TOPICAL 20130427 OTC MONOGRAPH NOT FINAL part348 Amata LLC CAMPHOR (NATURAL); MENTHOL 45; 367 mg/g; mg/g E 20171231 58177-293_68235c8d-a5fa-49c8-aebd-214e6c47e410 58177-293 HUMAN PRESCRIPTION DRUG metoprolol succinate extended-release metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091101 ANDA ANDA077176 Ethex Corporation METOPROLOL SUCCINATE 23.75 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 58177-310_44b9cb00-c457-4cc3-99e3-0db1be101fcd 58177-310 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091203 ANDA ANDA076733 ETHEX Corporation MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 58177-311_1969d6f2-3f37-4317-a73b-09158f83e59c 58177-311 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate TABLET ORAL 20091101 ANDA ANDA040365 Ethex Corporation DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 58177-312_1969d6f2-3f37-4317-a73b-09158f83e59c 58177-312 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate TABLET ORAL 20091101 ANDA ANDA040367 Ethex Corporation DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 58177-320_44b9cb00-c457-4cc3-99e3-0db1be101fcd 58177-320 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100422 ANDA ANDA076720 ETHEX Corporation MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 58177-330_44b9cb00-c457-4cc3-99e3-0db1be101fcd 58177-330 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100422 ANDA ANDA076720 ETHEX Corporation MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 58177-340_44b9cb00-c457-4cc3-99e3-0db1be101fcd 58177-340 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090101 ANDA ANDA077855 ETHEX Corporation MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 58177-358_61be400f-687b-4db4-8d15-8a7c1f8318cf 58177-358 HUMAN PRESCRIPTION DRUG metoprolol succinate extended-release metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091101 ANDA ANDA076640 Ethex Corporation METOPROLOL SUCCINATE 190 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 58177-368_61be400f-687b-4db4-8d15-8a7c1f8318cf 58177-368 HUMAN PRESCRIPTION DRUG metoprolol succinate extended-release metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091101 ANDA ANDA076640 Ethex Corporation METOPROLOL SUCCINATE 90 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 58177-369_274e757d-643f-4964-bd47-18016789a4ea 58177-369 HUMAN PRESCRIPTION DRUG metoprolol succinate extended-release metoprolol succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20091101 ANDA ANDA077176 Ethex Corporation METOPROLOL SUCCINATE 47.5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 58177-380_44b9cb00-c457-4cc3-99e3-0db1be101fcd 58177-380 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090101 ANDA ANDA077855 ETHEX Corporation MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 58177-677_b09b8a7e-4a56-4b4e-b03b-2769a9ce8c62 58177-677 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride controlled-release oxycodone hydrochloride TABLET, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020553 Ethex Corporation OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 58177-679_b09b8a7e-4a56-4b4e-b03b-2769a9ce8c62 58177-679 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride controlled-release oxycodone hydrochloride TABLET, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020553 Ethex Corporation OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 58177-681_b09b8a7e-4a56-4b4e-b03b-2769a9ce8c62 58177-681 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride controlled-release oxycodone hydrochloride TABLET, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020553 Ethex Corporation OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 58177-683_b09b8a7e-4a56-4b4e-b03b-2769a9ce8c62 58177-683 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride controlled-release oxycodone hydrochloride TABLET, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020553 Ethex Corporation OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 58177-910_75b15fab-4e46-4382-8754-8a54d5fa676b 58177-910 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SYRUP ORAL 20040510 ANDA ANDA040364 ETHEX Corporation PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 58180-104_3cfa7ca6-a33b-45bd-b729-448dfb2fb863 58180-104 HUMAN OTC DRUG Angel of mine Diaper Rash Zinc Oxide OINTMENT TOPICAL 20141118 OTC MONOGRAPH FINAL part347 Bicooya Cosmetics Limited ZINC OXIDE 160 mg/g N 20181231 58180-105_3e6ecd28-285c-4150-af64-0b636e0088b1 58180-105 HUMAN OTC DRUG Anti-Blemish Cleanser Salicylic Acid CREAM TOPICAL 20141216 OTC MONOGRAPH FINAL part358H Bicooya Cosmetics Limited SALICYLIC ACID 14 g/100g N 20181231 58180-194_4aaffc35-fa57-4c54-b956-f9514f117c7d 58180-194 HUMAN OTC DRUG rock sauce Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20160818 OTC MONOGRAPH NOT FINAL part348 Bicooya Cosmetics Limited METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 10; .2 mg/100mL; mg/100mL; mg/100mL N 20181231 58180-201_46bbfa7f-4f41-450a-b91a-206d7ce3dbef 58180-201 HUMAN OTC DRUG Assured T And Plus Coal Tar SHAMPOO TOPICAL 20140121 OTC MONOGRAPH FINAL part358H Bicooya Cosmetics Limited COAL TAR 5 mg/mL N 20181231 58180-210_d7d08a8a-5c5e-40a2-a2de-cae21477127d 58180-210 HUMAN OTC DRUG Clean hand sanitizer Ethyl Alcohol SPRAY TOPICAL 20141209 OTC MONOGRAPH NOT FINAL part333A Bicooya Cosmetics Limited ALCOHOL 62 mL/100mL N 20181231 58180-220_b500912e-bb3e-44af-9ed2-8fbf52bc8c00 58180-220 HUMAN OTC DRUG medi and lice lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20160524 OTC MONOGRAPH FINAL part358G Bicooya Cosmetics Limited PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 58181-3040_43669261-fce0-45c0-a28a-4871c7d670d5 58181-3040 HUMAN PRESCRIPTION DRUG Gleostine lomustine CAPSULE, GELATIN COATED ORAL 20140818 NDA NDA017588 NextSource Biotechnology, LLC LOMUSTINE 10 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 58181-3041_43669261-fce0-45c0-a28a-4871c7d670d5 58181-3041 HUMAN PRESCRIPTION DRUG Gleostine lomustine CAPSULE, GELATIN COATED ORAL 20140818 NDA NDA017588 NextSource Biotechnology, LLC LOMUSTINE 40 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 58181-3042_43669261-fce0-45c0-a28a-4871c7d670d5 58181-3042 HUMAN PRESCRIPTION DRUG Gleostine lomustine CAPSULE, GELATIN COATED ORAL 20140818 NDA NDA017588 NextSource Biotechnology, LLC LOMUSTINE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 58181-3043_43669261-fce0-45c0-a28a-4871c7d670d5 58181-3043 HUMAN PRESCRIPTION DRUG Gleostine lomustine CAPSULE, GELATIN COATED ORAL 20151105 NDA NDA017588 NextSource Biotechnology, LLC LOMUSTINE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 58194-001_2a11e608-3d1c-4fb4-a434-1a10fa697cff 58194-001 HUMAN OTC DRUG Modesa anti-bacterial hand gel Ethyl Alcohol GEL TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-002_40850807-7d60-46c8-a030-019bd469dd12 58194-002 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 68 mL/100mL E 20171231 58194-003_59376a6c-e672-4282-827f-958d58e6e665 58194-003 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 68 mL/100mL E 20171231 58194-004_28256b1f-829d-4b87-b172-4b752337ec86 58194-004 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 68 mL/100mL E 20171231 58194-005_072b9a9c-dbeb-4e06-8cbe-15e262d6cef0 58194-005 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 68 mL/100mL E 20171231 58194-006_84c590e8-6f91-47c2-b865-d13644a44132 58194-006 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 68 mL/100mL E 20171231 58194-007_456455cf-7860-4163-8a98-33c655e863ac 58194-007 HUMAN OTC DRUG Ocean Breeze Ethyl Alcohol GEL TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 68 mL/100mL E 20171231 58194-009_4f4b7ce8-cde7-41f5-8f0d-393575868e32 58194-009 HUMAN OTC DRUG Ocean Breeze Ethyl Alcohol GEL TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-010_48d40991-9f76-426c-aea7-fed6013da07d 58194-010 HUMAN OTC DRUG marshmallow ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-011_29782872-781c-410c-a26f-37bda9e1a215 58194-011 HUMAN OTC DRUG bubble gum ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-012_467a7139-66fa-4620-985b-ab8c3a7511fa 58194-012 HUMAN OTC DRUG Candy Apple ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-013_834d0fd6-9364-4913-b009-ff5ea84c5b3e 58194-013 HUMAN OTC DRUG Cotton Candy ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-014_437960aa-8aea-4e3e-bbf5-67d05590a2a9 58194-014 HUMAN OTC DRUG Cupcake ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-015_6f095668-8182-4ee9-a549-e9dd2183244d 58194-015 HUMAN OTC DRUG Lollipop ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-016_6bf48bf9-dd1c-454a-b467-a90c719623d2 58194-016 HUMAN OTC DRUG Sweet Pea ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-017_8e6cd599-5644-4633-8cb1-a582734e83f8 58194-017 HUMAN OTC DRUG Unscented ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-018_4c6995b8-d3cf-42f5-9aa2-01d93d06258c 58194-018 HUMAN OTC DRUG Vanilla ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-019_44fdbbb2-43c6-47f3-a54c-c1add795b4d2 58194-019 HUMAN OTC DRUG Zesty Lemon ethyl alcohol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-020_87f9037d-6db1-41f4-ad26-d4aef9e69528 58194-020 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-021_20b16592-a1b3-4ef7-acc7-b4a02243854d 58194-021 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-022_6446f041-7dbe-4b2f-b94d-1d9d7b352482 58194-022 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20150625 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-023_64a5fb64-575f-4489-ad1b-126fd4e943f5 58194-023 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20150625 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-024_271761cf-132c-4ce0-b66f-0427bc852f30 58194-024 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20150625 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-025_839244b1-c9f5-4fde-940f-b0cb94657c38 58194-025 HUMAN OTC DRUG Modesa Ethyl Alcohol GEL TOPICAL 20150625 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-026_6b1ac723-53a9-47fd-b6c1-fd4b77c70d98 58194-026 HUMAN OTC DRUG sassy strawberry Ethyl Alcohol GEL TOPICAL 20150703 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-027_8ef1908d-5835-4a19-9640-472be2885b2b 58194-027 HUMAN OTC DRUG floral frenzy Ethyl Alcohol GEL TOPICAL 20150703 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-028_4560fe9f-23a4-4776-8e60-9e301018ba20 58194-028 HUMAN OTC DRUG luscious lime Ethyl Alcohol GEL TOPICAL 20150703 OTC MONOGRAPH NOT FINAL part333A Shanghai Weierya Daily Chemicals Factory ALCOHOL 65 mL/100mL E 20171231 58194-029_69014d59-4336-487e-a6d8-821fece41e53 58194-029 HUMAN OTC DRUG Assured Bug Bite Relief Sodium Bicarbonate LIQUID TOPICAL 20151110 UNAPPROVED DRUG OTHER Shanghai Weierya Daily Chemicals Factory SODIUM BICARBONATE 5 g/100g E 20171231 58194-030_83981039-7f29-40e3-83fa-4496ae3c7e03 58194-030 HUMAN OTC DRUG Advanced Acne Spot Treatment SALICYLIC ACID GEL TOPICAL 20160111 OTC MONOGRAPH FINAL part333D Shanghai Weierya Daily Chemicals Factory SALICYLIC ACID 2 g/100g E 20171231 58194-031_425328b8-9552-462b-bb07-3646b8277680 58194-031 HUMAN OTC DRUG Blackhead Cleaning Scrub SALICYLIC ACID CREAM TOPICAL 20160111 OTC MONOGRAPH FINAL part333D Shanghai Weierya Daily Chemicals Factory SALICYLIC ACID 2 g/100g E 20171231 58194-039_22bc3c5a-e75c-4843-b6a2-7be76272f76c 58194-039 HUMAN OTC DRUG Assured Bug Bite Relief Sodium Bicarbonate LIQUID TOPICAL 20151110 OTC MONOGRAPH FINAL part347 Shanghai Weierya Daily Chemicals Factory SODIUM BICARBONATE 5 g/100g E 20171231 58194-044_89cb9b4a-194d-479e-9d59-a0a967f99bd2 58194-044 HUMAN OTC DRUG Acne Treatment Pads SALICYLIC ACID PATCH TOPICAL 20160717 OTC MONOGRAPH FINAL part333D Shanghai Weierya Daily Chemicals Factory SALICYLIC ACID 2 g/100mL E 20171231 58194-054_42ab830f-8e52-4c3a-b124-3f57186fc921 58194-054 HUMAN OTC DRUG Anti-Blemish Cleanser SALICYLIC ACID CREAM TOPICAL 20160717 OTC MONOGRAPH FINAL part333D Shanghai Weierya Daily Chemicals Factory SALICYLIC ACID 2 g/100g E 20171231 58194-600_44a5718c-987c-4011-ac3d-18107523c1f3 58194-600 HUMAN OTC DRUG Family Wellness Liquid Wart Remover SALICYLIC ACID LIQUID TOPICAL 20170625 OTC MONOGRAPH FINAL part358B Shanghai Weierya Daily Chemicals Factory SALICYLIC ACID 17 g/100mL N 20181231 58214-100_1dea5f49-ef1a-465f-9757-a50a0ed237c6 58214-100 HUMAN OTC DRUG beyond nicotine kit CALADIUM SEGUINUM, KALI SULPH, PLANTAGO MAJOR, NICOTIANA TABACUM, CALCIUM SULFATE ANHYDROUS, LOBELIA INFLATA, SAMBUCUS NIGRA FLOWERING TOP, DELPHINIUM STAPHISAGRIA SEED KIT ORAL; ORAL 20130417 UNAPPROVED HOMEOPATHIC JMSP USA LLC N 20181231 58214-123_6d3701dc-cffc-4cce-8e55-77ebce864dfb 58214-123 HUMAN OTC DRUG beyond heartbreak Ignatia, Natrum Muriaticum , Pulsatilla,Staphysagria SPRAY ORAL 20170610 UNAPPROVED HOMEOPATHIC JMSP USA LLC STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; ANEMONE PULSATILLA; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 30 [hp_C]/30mL; 1/30mL; 1/30mL; 1/30mL N 20181231 58214-456_d3e0fe2f-27e5-469d-b857-6d3b3ae227b5 58214-456 HUMAN OTC DRUG beyond insomnia Cocculus, Coffee tosta and nux vomica SPRAY ORAL 20170610 UNAPPROVED HOMEOPATHIC JMSP USA LLC ANAMIRTA COCCULUS SEED; COFFEA ARABICA SEED, ROASTED; STRYCHNOS NUX-VOMICA SEED 30; 30; 30 [hp_C]/30mL; 1/30mL; 1/30mL N 20181231 58214-789_f9552597-c0a4-4c18-aed0-a26523759b8e 58214-789 HUMAN OTC DRUG Beyond Nicotine Kali Sulph, Nicotinum , Plantago and Tabacum SPRAY ORAL 20170610 UNAPPROVED HOMEOPATHIC JMSP USA LLC POTASSIUM SULFATE; NICOTINE; PLANTAGO MAJOR; TOBACCO LEAF 6; 9; 9; 9 [hp_X]/30mL; 1/30mL; 1/30mL; 1/30mL N 20181231 58223-517_f5c52645-b7ad-4003-b5c2-f5204369726e 58223-517 HUMAN PRESCRIPTION DRUG FLURA-DROPS SODIUM FLUORIDE LIQUID ORAL 20140501 UNAPPROVED DRUG OTHER KIRKMAN GROUP, INC. SODIUM FLUORIDE 2.21 mg/.2mL N 20181231 58223-678_2dbe3b83-88c6-4a8f-befa-abc2e3cbf8c4 58223-678 HUMAN PRESCRIPTION DRUG SODIUM FLUORIDE CHERRY SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20111001 UNAPPROVED DRUG OTHER KIRKMAN GROUP, INC. SODIUM FLUORIDE .5 mg/1 N 20181231 58223-679_6d89b4bd-4189-4964-8106-99c86a43a6d9 58223-679 HUMAN PRESCRIPTION DRUG SODIUM FLUORIDE CHERRY SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20111001 UNAPPROVED DRUG OTHER KIRKMAN GROUP, INC. SODIUM FLUORIDE 1 mg/1 N 20181231 58228-0102_8af1b91c-d74f-4ba4-9543-2a176ed3631a 58228-0102 HUMAN OTC DRUG ProStat Protective Coating Bandage First Aid benzethonium chloride and benzocaine AEROSOL, SPRAY TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333A ProStat First Aid BENZETHONIUM CHLORIDE; BENZOCAINE 170; 2720 mg/85g; mg/85g E 20171231 58228-0103_0cde8593-950a-43ce-be26-3c6f39291cd0 58228-0103 HUMAN OTC DRUG ProStat Blood Clotting First Aid benzethonium chloride and lidocaine AEROSOL, SPRAY TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part348 ProStat First Aid LIDOCAINE; BENZETHONIUM CHLORIDE 3400; 170 mg/85g; mg/85g E 20171231 58228-0104_76ed0b78-ff53-4140-82d1-3d1fa32f8c63 58228-0104 HUMAN OTC DRUG ProStat Antiseptic First Aid benzocaine and benzethonium chloride AEROSOL, SPRAY TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part348 ProStat First Aid BENZETHONIUM CHLORIDE; BENZOCAINE 170; 8500 mg/85g; mg/85g E 20171231 58228-0105_7518092e-2c65-42be-bf2e-8a665defe6c1 58228-0105 HUMAN OTC DRUG ProStat Burn First Aid benzethonium chloride, benzocaine, and menthol AEROSOL, SPRAY TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part348 ProStat First Aid BENZETHONIUM CHLORIDE; BENZOCAINE; MENTHOL 170; 8500; 281 mg/85g; mg/85g; mg/85g E 20171231 58228-5600_fb769e20-f961-411c-a90f-6f064f5fdb7b 58228-5600 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20130920 OTC MONOGRAPH FINAL part333B ProStat First Aid BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 58231-001_4d01bfba-2dd9-4951-a761-8aa6f4f697bc 58231-001 HUMAN OTC DRUG Snowberry Zinc Oxide CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Snowberry New Zealand Ltd ZINC OXIDE; KAEMPFERIA GALANGA ROOT; ETHYL FERULATE; LARIX SIBIRICA WOOD 1.6; .7; .7; .3 g/10g; g/10g; g/10g; g/10g E 20171231 58231-002_4de0e878-6b0f-40c5-ad03-c3c2ba54b9af 58231-002 HUMAN OTC DRUG Snowberry Zinc Oxide CREAM TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 Snowberry New Zealand Ltd ZINC OXIDE; KAEMPFERIA GALANGA ROOT; ETHYL FERULATE; LARIX SIBIRICA WOOD 2.2; .7; .6; .3 g/10g; g/10g; g/10g; g/10g E 20171231 58232-0001_7bbe5915-bf27-4d52-8a14-045f377a0a72 58232-0001 HUMAN OTC DRUG Aveeno Positively Radiant CC Broad Spectrum SPF30 - Medium Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58232-0002_9e93babc-e2f6-4b20-92bf-c4f588ba622f 58232-0002 HUMAN OTC DRUG Aveeno Positively Radiant CC Broad Spectrum SPF30 - Fair to Light Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20140428 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58232-0006_fcd1267e-306b-4822-b454-62ba909e710f 58232-0006 HUMAN OTC DRUG Clean and Clear Advantage 3 in 1 Exfoliating Benzoyl Peroxide CREAM TOPICAL 20140701 20181001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 50 mg/g N 20181231 58232-0007_0b28b275-b357-4534-938b-ae767124b004 58232-0007 HUMAN OTC DRUG Aveeno Baby Soothing Relief Moisturizing Dimethicone CREAM TOPICAL 20151022 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 125 mg/g N 20181231 58232-0010_278a5886-5609-41e2-90ae-c2deb6dfb408 58232-0010 HUMAN OTC DRUG Aveeno Positively Radiant CC Eye Broad Spectrum SPF25 - Fair to Light Titanium Dioxide CREAM TOPICAL 20150515 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE 18.8 mg/mL N 20181231 58232-0011_62222835-fd2a-4fb5-8210-5ea9f692bb3a 58232-0011 HUMAN OTC DRUG Aveeno Positively Radiant CC Eye Broad Spectrum SPF25 - Medium Titanium Dioxide CREAM TOPICAL 20150515 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE 18.8 mg/mL N 20181231 58232-0016_6cc56946-f10d-4797-ba83-62364d5187d2 58232-0016 HUMAN OTC DRUG Band-Aid Brand Hurt-Free Antiseptic Wash Benzalkonium Chloride and Lidocaine Hydrochloride LIQUID TOPICAL 20111214 20180804 OTC MONOGRAPH NOT FINAL part333A Johnson & Johnson Consumer Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 20 mg/mL; mg/mL N 20181231 58232-0018_0a315bde-5496-44ef-96e7-46b93ad67352 58232-0018 HUMAN OTC DRUG Aveeno Baby Eczema Therapy Soothing Bath Treatment Oatmeal POWDER TOPICAL 20111128 20180314 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 430 mg/g N 20181231 58232-0032_57fb1b45-68b6-4962-bf1b-5b9f2d9496d3 58232-0032 HUMAN OTC DRUG Clean and Clear Advantage Popped Pimple Relief Salicylic Acid PASTE TOPICAL 20101201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/g N 20181231 58232-0039_51b89a73-b1f7-49e7-a5fd-1eb793cf09aa 58232-0039 HUMAN OTC DRUG Aveeno Active Naturals Skin Relief Overnight Dimethicone CREAM TOPICAL 20070522 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 13 mg/g N 20181231 58232-0040_eb91a605-b2db-4287-b1a6-81eed66012d7 58232-0040 HUMAN OTC DRUG Aveeno Active Naturals Natural Protection Broad Spectrum SPF30 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120110 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 43; 30 mg/g; mg/g N 20181231 58232-0048_6e295b9b-809b-438d-af4e-c9446f9a746f 58232-0048 HUMAN OTC DRUG Aveeno Active Naturals Eczema Therapy Hand Oatmeal CREAM TOPICAL 20140501 20180802 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 10 mg/g N 20181231 58232-0049_90000ab9-9a75-4d1c-83b8-a535f4c2f0a4 58232-0049 HUMAN OTC DRUG Neosporin Eczema Essentials Daily Moisturizing Oatmeal CREAM TOPICAL 20111115 20180901 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 10 mg/g N 20181231 58232-0050_2a26b836-8313-472b-9af2-165b69fa9f65 58232-0050 HUMAN OTC DRUG Aveeno Active Naturals Positively Ageless Correcting Tinted Moisturizer Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20120909 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; meq/mL; mg/mL N 20181231 58232-0054_ee31f831-7dd5-4c2a-bf33-f237e08aceac 58232-0054 HUMAN OTC DRUG Clean and Clear Advantage Acne Cleanser Salicylic Acid LIQUID TOPICAL 20120206 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL N 20181231 58232-0059_2689ce83-5264-4314-8108-a8d58a3f8940 58232-0059 HUMAN OTC DRUG Clean and Clear Essentials Dual Action Moisturizer Salicylic Acid LOTION TOPICAL 20130624 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/mL N 20181231 58232-0062_60208b99-5979-4352-b5b6-ed6e37b4d67e 58232-0062 HUMAN OTC DRUG Clean and Clear Advantage Daily Soothing Acne Scrub Salicylic Acid CREAM TOPICAL 20120919 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/g N 20181231 58232-0063_17d41a1d-f32c-4df8-b378-361f847afbda 58232-0063 HUMAN OTC DRUG Clean and Clear Advantage Acne Control 3 in 1 Foaming Wash Salicylic Acid LIQUID TOPICAL 20131013 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL N 20181231 58232-0066_804659b5-dd55-43ea-a759-db5e567b38b7 58232-0066 HUMAN OTC DRUG Aveeno Active Naturals Nourish Plus Dandruff Control Anti Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20121010 OTC MONOGRAPH FINAL part358H Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. PYRITHIONE ZINC 10.2 mg/mL N 20181231 58232-0067_37020e23-4d97-42ee-a9ec-a7474d60e8fb 58232-0067 HUMAN OTC DRUG Aveeno Active Naturals Nourish Plus Dandruff Control Anti Dandruff 2 in 1 Shampoo and Conditioner Pyrithione Zinc LIQUID TOPICAL 20121010 OTC MONOGRAPH FINAL part358H Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. PYRITHIONE ZINC 10.2 mg/mL N 20181231 58232-0069_d7b4a086-f966-4e71-9310-75d61b4ecd42 58232-0069 HUMAN OTC DRUG Aveeno Active Naturals Nourish Plus Dandruff Control Anti Dandruff Conditioner Pyrithione Zinc LIQUID TOPICAL 20121010 OTC MONOGRAPH FINAL part358H Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. PYRITHIONE ZINC 4.9 mg/mL N 20181231 58232-0104_c1808415-edc0-45ac-9ea8-1bdce91e73c6 58232-0104 HUMAN OTC DRUG Aveeno Baby Daily Moisture Dimethicone LOTION TOPICAL 20101201 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 12 mg/mL N 20181231 58232-0208_14c73155-1b29-475c-bc8f-2bbc7742d27c 58232-0208 HUMAN OTC DRUG Aveeno ACTIVE NATURALS clear complexion daily moisturizer Salicylic Acid LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 58232-0210_feeb2ea9-d17e-4aed-ad4f-8c9cafafe773 58232-0210 HUMAN OTC DRUG Aveeno Clear Complexion Foaming Cleanser Salicylic Acid LIQUID TOPICAL 20110823 20180701 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 58232-0211_aee93389-6c47-431f-a540-07df8131af41 58232-0211 HUMAN OTC DRUG Aveeno Baby Calming Comfort Dimethicone LOTION TOPICAL 20020101 20180901 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 12 mg/mL N 20181231 58232-0218_269eb2a5-0796-410b-925c-7a64dc636848 58232-0218 HUMAN OTC DRUG Clean and Clear Continuous Control Acne Cleanser Benzoyl Peroxide CREAM TOPICAL 20100120 20181001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 100 mg/g N 20181231 58232-0219_be3586ac-9fcb-4dc6-a133-17aebd720556 58232-0219 HUMAN OTC DRUG Clean and Clear Continuous Control Acne Cleanser Benzoyl Peroxide CREAM TOPICAL 20150624 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BENZOYL PEROXIDE 100 mg/g N 20181231 58232-0316_1e1bcb1a-566d-4586-8fe5-9bac883e26e2 58232-0316 HUMAN OTC DRUG Clean and Clear Advantage Acne Spot Treatment Salicylic Acid LOTION TOPICAL 20120504 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL N 20181231 58232-0317_8a188675-9d76-4118-b75d-d3a152d4286c 58232-0317 HUMAN OTC DRUG Clean and Clear Morning Glow Moisturizer Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20121004 20181001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL N 20181231 58232-0327_0e214588-029d-4cee-acda-df5ccce042cc 58232-0327 HUMAN OTC DRUG Clean and Clear Advantage Mark Treatment Salicylic Acid LOTION TOPICAL 20131023 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL N 20181231 58232-0329_c8513422-c7d2-4931-b712-88078f1153a8 58232-0329 HUMAN OTC DRUG Clean and Clear blackhead eraser cleansing mask Salicylic Acid CREAM TOPICAL 20090515 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/g N 20181231 58232-0411_f186056d-9335-49d6-99dd-d892c5a59836 58232-0411 HUMAN OTC DRUG Clean and Clear Sensitive Skin Salicylic Acid LIQUID TOPICAL 20110707 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/mL N 20181231 58232-0412_d4c485f6-f0d5-4802-9988-2e87fab81d49 58232-0412 HUMAN OTC DRUG Clean and Clear Deep Cleaning Salicylic Acid LIQUID TOPICAL 20110627 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 20 mg/mL N 20181231 58232-0423_cbc686cb-c114-4fc2-991e-6622b8681beb 58232-0423 HUMAN OTC DRUG Neosporin Original Bacitracin, Neomycin, Polymyxin B KIT 20110804 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. N 20181231 58232-0424_049ba971-6efb-428a-a671-466b151a6a44 58232-0424 HUMAN OTC DRUG Neosporin Original Bacitracin, Neomycin, Polymyxin B KIT 20110829 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. N 20181231 58232-0501_9998c7f0-5636-4250-a926-b570e5a5c3f7 58232-0501 HUMAN OTC DRUG Aveeno Active Naturals Essential Moisture Lip Conditioner Dimethicone STICK TOPICAL 20120727 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. DIMETHICONE 10 mg/g N 20181231 58232-0512_edbf98d1-cfa7-49f1-8190-c87daa14ecfe 58232-0512 HUMAN OTC DRUG Aveeno Ultra-Calming Daily Moisturizer SPF 30 Homosalate, Octinoxate, Octisalate and Titanium Dioxide LOTION TOPICAL 20090825 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 51.3; 76.9; 51.3; 24.6 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58232-0526_e5243e58-138b-49f2-b221-f92252d03537 58232-0526 HUMAN OTC DRUG Aveeno Eczema Therapy Bath Treatment Oatmeal POWDER TOPICAL 20120222 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 1000 mg/g N 20181231 58232-0527_6aa2b816-1978-4db9-b4af-3edaa82ec410 58232-0527 HUMAN OTC DRUG Aveeno Active Naturals Eczema Therapy Care oatmeal KIT 20120222 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. N 20181231 58232-0528_4d99bb1b-f6d4-4a65-9d0d-974b69fc7917 58232-0528 HUMAN OTC DRUG Aveeno Eczema Therapy Moisturizing Oatmeal CREAM TOPICAL 20120222 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 10 mg/g N 20181231 58232-0531_307c451d-65cf-4a10-831d-00e07f246141 58232-0531 HUMAN OTC DRUG Aveeno Baby Natural Protection Face Sunscreen Broad Spectrum SPF50 Titanium Dioxide and Zinc Oxide STICK TOPICAL 20121018 20180501 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE; ZINC OXIDE 80.9; 68 mg/g; mg/g N 20181231 58232-0533_66e12ec8-2646-476e-aa15-61364ed1fe73 58232-0533 HUMAN OTC DRUG Aveeno Active Naturals Skin Relief 24hr Moisturizing Fragrance Free Dimethicone LOTION TOPICAL 20051201 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 12 mg/mL N 20181231 58232-0603_8fb07336-64a0-4cae-9f78-f90b2ccabaf4 58232-0603 HUMAN OTC DRUG Aveeno Active Naturals Positively Radiant Daily Moisturizer with sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58232-0626_8d59ca29-4399-41d8-af75-b0c667321b4e 58232-0626 HUMAN OTC DRUG Aveeno Baby Continuous Protection Sunscreen Broad Spectrum SPF55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 28; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 58232-0631_36ad334d-eb8b-49d6-a110-1e222bda74d9 58232-0631 HUMAN OTC DRUG Aveeno Baby Soothing Relief Diaper Rash Fragrance Free Zinc Oxide CREAM TOPICAL 20110817 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. ZINC OXIDE 130 mg/g N 20181231 58232-0632_b1db69e4-df36-4416-9453-6791c39824c2 58232-0632 HUMAN OTC DRUG Clean and Clear Advantage Acne Control Moisturizer Salicylic Acid LOTION TOPICAL 20061015 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. SALICYLIC ACID 5 mg/mL N 20181231 58232-0636_9aac0cd9-8473-4fdf-81a9-28faa12d8856 58232-0636 HUMAN OTC DRUG Aveeno Active Naturals Clear Complexion BB Sunscreen Broad Spectrum SPF30 Fair to Light Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58232-0637_95611566-e503-40d0-a677-ddf71c4f33e8 58232-0637 HUMAN OTC DRUG Aveeno Active Naturals Hydrosport Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120524 20181201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 80; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 58232-0639_88f1d0a6-ff4f-48ff-858d-53e0c2e14d77 58232-0639 HUMAN OTC DRUG Aveeno Active Naturals Positively Radiant Tinted Moisturizer - Fair to Light Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20121004 20181001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58232-0640_a193950f-cb63-40ff-a33a-61c4a676b9a8 58232-0640 HUMAN OTC DRUG Aveeno Active Naturals Positively Radiant Tinted Moisturizer - Medium Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20121004 20181001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58232-0641_bb9200e8-9fd0-402c-9e1e-cdbe450f545d 58232-0641 HUMAN OTC DRUG Aveeno Active Naturals Clear Complexion BB Broad Spectrum SPF30 - Medium Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 50; 75; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58232-0649_a16112c4-9b69-4710-a995-13a6bb92e84e 58232-0649 HUMAN OTC DRUG Aveeno Positively Ageless SPF55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100104 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 28; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 58232-0654_73a0b172-6c09-4706-8516-0c823b179b82 58232-0654 HUMAN OTC DRUG Aveeno Positively Ageless Face SPF90 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100104 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 58232-0702_22d0325b-24af-4776-bbf2-7ab916306e69 58232-0702 HUMAN OTC DRUG Aveeno Clear Complexion Cleanser Salicylic Acid CREAM TOPICAL 20130620 20181013 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/g N 20181231 58232-0711_b33cb6d8-3c0c-43e9-a5e9-2206643dfbf2 58232-0711 HUMAN OTC DRUG Neosporin Plus Pain Relief Neo To Go First Aid Antiseptic Pain Relieving BENZALKONIUM CHLORIDE AND PRAMOXINE HYDROCHLORIDE SPRAY TOPICAL 20071201 20180801 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. BENZALKONIUM CHLORIDE; PRAMOXINE HYDROCHLORIDE 1.3; 10 mg/mL; mg/mL N 20181231 58232-0720_b3291d42-9393-43cd-a20d-bbc0883568ff 58232-0720 HUMAN OTC DRUG Desitin Rapid Relief Creamy Diaper Rash Zinc Oxide CREAM TOPICAL 20110515 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. ZINC OXIDE 130 mg/g N 20181231 58232-0722_8ab6b8bd-7d70-48d6-9759-d7debd154a28 58232-0722 HUMAN OTC DRUG Desitin Multi-Purpose Skin Protectant Petrolatum OINTMENT TOPICAL 20110101 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. PETROLATUM 703.2 mg/g N 20181231 58232-0723_00b74c1a-54fa-4eff-bd1b-7474173e34c7 58232-0723 HUMAN OTC DRUG Desitin Rapid Relief Creamy Fragrance Free Zinc Oxide CREAM TOPICAL 20130715 20180501 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. ZINC OXIDE 130 mg/g N 20181231 58232-0740_a406ec1f-71b5-40e4-8abf-79bd5ae4afca 58232-0740 HUMAN OTC DRUG Benadryl Original Strength Itch Stopping Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20121015 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/g; mg/g N 20181231 58232-0741_1794d47e-6dff-4a9d-9f71-3ff4e0202a7c 58232-0741 HUMAN OTC DRUG Benadryl Extra Strength Itch Stopping Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20121015 20180901 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 58232-0742_7d1522ec-7ff5-4c70-9300-9588088945a6 58232-0742 HUMAN OTC DRUG Benadryl Extra Strength Itch Relief Diphenhydramine Hydrochloride and Zinc Acetate SOLUTION TOPICAL 20120401 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/mL; mg/mL N 20181231 58232-0744_df142e2a-a383-455b-9051-788b7fc6971d 58232-0744 HUMAN OTC DRUG Benadryl Extra Strength Itch Stopping Diphenhydramine Hydrochloride GEL TOPICAL 20130213 20190901 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/mL N 20181231 58232-0750_1734ccc8-464b-4c1e-bb56-d6b656faaef4 58232-0750 HUMAN OTC DRUG BENADRYL Extra Strength Itch Cooling Diphenhydramine Hydrochloride and Zinc Acetate SPRAY TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/mL; mg/mL N 20181231 58232-0751_cbccd266-b375-472e-8ce8-07c4c21799ce 58232-0751 HUMAN OTC DRUG Childrens Benadryl Itch Cooling CAMPHOR (SYNTHETIC) GEL TOPICAL 20120427 20181001 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. CAMPHOR (SYNTHETIC) 4.5 mg/g N 20181231 58232-0752_36f6af49-a362-4466-a35b-edd2cc84c814 58232-0752 HUMAN OTC DRUG Aveeno Active Naturals Daily Moisturizing Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120503 20180609 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58232-0753_972194c3-345b-47b6-9b10-00d1af77a0bd 58232-0753 HUMAN OTC DRUG Lubriderm Daily Moisture Sunscreen Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100701 20190801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 40; 30; 22 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58232-0754_53f27c8e-3888-4f6e-acc2-a0b9a17c40ca 58232-0754 HUMAN OTC DRUG Clean and Clear blackhead eraser scrub Salicylic Acid CREAM TOPICAL 20120531 20180601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/g N 20181231 58232-0755_5278e623-5370-4ea4-a39a-882c70f666cd 58232-0755 HUMAN OTC DRUG Aveeno Active Naturals Smart Essentials Daily Nourishing Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120601 20180601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58232-0801_7fdbe0ea-aeb8-4141-ba48-269099f2a83f 58232-0801 HUMAN OTC DRUG Clean and Clear Advantage Oil Absorbing Cleanser Salicylic Acid CREAM TOPICAL 20120412 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 58232-0802_9c6e2a22-1e52-4ff0-9e6a-bef37b4fa37f 58232-0802 HUMAN OTC DRUG Clean and Clear Advantage Oil Absorbing Treatment Salicylic Acid LOTION TOPICAL 20120412 20180714 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 58232-0805_313b999d-0b97-46b5-aba4-ce9896f18f99 58232-0805 HUMAN OTC DRUG Aveeno Baby Natural Protection Sunscreen Broad Spectrum SPF 50 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120913 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/g; mg/g N 20181231 58232-0806_b2899046-2e0f-469c-afba-b49306cb7718 58232-0806 HUMAN OTC DRUG Aveeno Natural Protection Sunscreen Broad Spectrum SPF 50 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 30 mg/g; mg/g N 20181231 58232-0809_1938e5ee-c57d-4576-b3b3-bdf1cea85507 58232-0809 HUMAN OTC DRUG Aveeno Active Naturals Protect Plus Hydrate Sunscreen Broad Spectrum SPF50 For Face Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20120712 20180304 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 60; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 58232-1402_c1f5d6ea-34d2-4600-90b5-44a44d0eb6a9 58232-1402 HUMAN OTC DRUG Aveeno Hydrocortisone Anti Itch Hydrocortisone CREAM TOPICAL 20121008 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HYDROCORTISONE 10 mg/g N 20181231 58232-1403_d751bb58-a42a-40bb-b49a-98db88c7b38f 58232-1403 HUMAN OTC DRUG Aveeno Active Naturals Eczema Therapy Moisturizing Oatmeal CREAM TOPICAL 20100501 20180901 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 10 mg/g N 20181231 58232-1404_c96d005b-b757-4ae1-b7d7-a8fe7d87c747 58232-1404 HUMAN OTC DRUG Aveeno Baby Eczema Therapy Moisturizing Oatmeal CREAM TOPICAL 20110629 20180801 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 10 mg/g N 20181231 58232-1405_2efa45ee-9bd7-4315-9d5a-a5f2d0edd7fb 58232-1405 HUMAN OTC DRUG Aveeno Baby Eczema Therapy Oatmeal CREAM TOPICAL 20100818 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. OATMEAL 10.3 mg/g N 20181231 58232-4001_e2357383-315d-4fc6-b214-39468de2a1b8 58232-4001 HUMAN OTC DRUG Neosporin Plus Pain Relief First Aid Antibiotic/Pain Relieving Neomycin, Polymyxin B, and Pramoxine Hydrochloride CREAM TOPICAL 20130708 20180501 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. NEOMYCIN; POLYMYXIN B; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g N 20181231 58232-4002_1a883260-6959-492c-9080-42a80ac87d63 58232-4002 HUMAN OTC DRUG Neosporin Original Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20110803 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 58232-4003_ef68cd15-eea2-4852-bb34-50b90e37f697 58232-4003 HUMAN OTC DRUG Neosporin Plus Pain Relief Bacitracin, Neomycin, Polymyxin B, and Pramoxine Hydrochloride OINTMENT TOPICAL 20091201 20180501 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 58232-4010_477e2e9a-d6c4-4e0d-9799-41b3a54af2b9 58232-4010 HUMAN OTC DRUG Neosporin Eczema Essentials Anti Itch Hydrocortisone CREAM TOPICAL 20110930 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. HYDROCORTISONE 10 mg/g N 20181231 58232-4013_b019b8b6-12d7-4cab-92fa-1e31fcd22f4d 58232-4013 HUMAN OTC DRUG Neosporin Plus Pain Relief First Aid Antibiotic Pain Relieving For Kids Neomycin, Polymyxin B, and Pramoxine Hydrochloride CREAM TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. NEOMYCIN; POLYMYXIN B; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g N 20181231 58232-4015_2d4a3cde-dd3f-4a1c-a870-ca39fb18b3cb 58232-4015 HUMAN OTC DRUG BENGAY Pain Relief and Massage Menthol GEL TOPICAL 20091231 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson Consumer Companies, Inc. MENTHOL 2.5 g/100g N 20181231 58232-4016_4a2f325e-14c8-4939-900f-141ec608f374 58232-4016 HUMAN OTC DRUG Bengay Vanishing Scent Pain Relieving MENTHOL GEL TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. RACEMENTHOL 25 mg/g N 20181231 58232-4018_2337c29e-e05c-4a3d-a16a-03bc45d0cbde 58232-4018 HUMAN OTC DRUG Neosporin Wound Cleanser Benzalkonium Chloride LIQUID TOPICAL 20110622 20180901 OTC MONOGRAPH NOT FINAL part333A Johnson & Johnson Consumer Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 58232-4024_8180168f-9a2e-47f6-89a6-af941120b131 58232-4024 HUMAN OTC DRUG Bengay Ultra Strength Non Greasy Pain Relieving Camphor (Synthetic), Menthol, and Methyl Salicylate CREAM TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g N 20181231 58232-4026_56eba23a-0261-4eb9-821c-2ec661f0caca 58232-4026 HUMAN OTC DRUG Bengay Ultra Strength Pain Relieving Regular Size Menthol PATCH TOPICAL 20110922 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL 50 mg/1 N 20181231 58232-4033_20f2bbe4-38a2-48f5-a211-abbc2c9176fa 58232-4033 HUMAN OTC DRUG Polysporin Polymyxin B Sulfate and Bacitracin Zinc POWDER TOPICAL 20100614 OTC MONOGRAPH FINAL part333 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. POLYMYXIN B SULFATE; BACITRACIN ZINC 10000; 500 [USP'U]/g; [USP'U]/g N 20181231 58232-4034_3dcbde11-6275-498c-9b5e-49fecd29d659 58232-4034 HUMAN OTC DRUG Polysporin First Aid Antibiotic Bacitracin and polymyxin B sulfate OINTMENT TOPICAL 20130709 20181101 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Inc. BACITRACIN; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 58232-4035_a8c3df2f-10f5-481c-b929-290b17b2bf9a 58232-4035 HUMAN OTC DRUG Neosporin Lip Health Overnight Renewal Therapy Petrolatum OINTMENT TOPICAL 20110603 20180901 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. PETROLATUM 774 mg/g N 20181231 58232-4036_0900d53d-cab6-4b49-b58a-59675a69a824 58232-4036 HUMAN OTC DRUG Bengay Zero Degrees Menthol Pain Relieving Menthol CREAM TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL 50 mg/g N 20181231 58232-6000_b6c7b8e7-6bc9-45ef-adfe-28f81e7e9354 58232-6000 HUMAN OTC DRUG Bengay Ultra Strength Regular Size Menthol PATCH TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL 50 mg/1 N 20181231 58232-6001_f1b8acc8-71f3-47b4-a864-605fc2254e09 58232-6001 HUMAN OTC DRUG Bengay Ultra Strength Large Size Menthol PATCH TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part348 JJohnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. MENTHOL 50 mg/1 N 20181231 58232-6003_4feb4f30-a521-4dd2-97a7-c329c9cd8aa8 58232-6003 HUMAN OTC DRUG Clean and Clear Essentials Deep Cleaning Toner Sensitive Skin Salicylic Acid LIQUID TOPICAL 20120427 20180801 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 58232-6004_f6884a30-3294-4fb8-994e-76ea7170114d 58232-6004 HUMAN OTC DRUG Clean and Clear Essentials Deep Cleaning Astringent Salicylic Acid LIQUID TOPICAL 20120430 20180801 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 58232-6036_94e09786-1a33-4311-9f57-7bca59b8c0e2 58232-6036 HUMAN OTC DRUG Aveeno Active Naturals Positively Ageless Youth Perfecting Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120524 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58232-9201_773de8a9-447a-400d-a1d9-b48005b96ee2 58232-9201 HUMAN OTC DRUG Johnsons Baby Pure Cornstarch Medicated Zinc Oxide POWDER TOPICAL 20140204 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. ZINC OXIDE 100 mg/g N 20181231 58232-9202_5eb09c73-dcca-4a5f-88ea-7a79c7400448 58232-9202 HUMAN OTC DRUG Johnsons Baby Intense Moisture Dimethicone CREAM TOPICAL 20130103 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 20 mg/g N 20181231 58232-9205_cd79186a-08f9-44e9-a9b3-714c406d02a7 58232-9205 HUMAN OTC DRUG Johnsons Baby Bathtime Gift Set Zinc Oxide KIT 20150707 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. N 20181231 58232-9612_612f95b7-45f7-4f6c-b914-715ffaaa7602 58232-9612 HUMAN OTC DRUG Neosporin Plus Pain Relief Neo to Go Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20110201 20181001 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 58232-9814_069abbe4-c388-4230-8937-3b15c5ac44af 58232-9814 HUMAN OTC DRUG Clean and Clear Persa-Gel 10 Benzoyl Peroxide GEL TOPICAL 20110601 20181012 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 100 mg/g N 20181231 58232-9907_7ad54d31-e19a-4eec-8eb6-895824af6e6a 58232-9907 HUMAN OTC DRUG Aveeno Active Naturals Daily Moisturizing Dimethicone CREAM TOPICAL 20100901 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 12 mg/g N 20181231 58232-9910_26f2aa3f-cf2a-45c3-8786-acf94d297383 58232-9910 HUMAN OTC DRUG Aveeno Anti Itch Concentrated Zinc Oxide, Ferric Oxide Red, and Pramoxine Hydrochloride LOTION TOPICAL 20121107 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. ZINC OXIDE; FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE 29.4; .6; 10 mg/mL; mg/mL; mg/mL N 20181231 58232-9911_62890a4c-5dea-41de-9732-673882b3aa59 58232-9911 HUMAN OTC DRUG Aveeno Calamine and Pramoxine Hydrochloride Anti Itch Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride CREAM TOPICAL 20130620 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE .6; 29.4; 10 mg/g; mg/g; mg/g N 20181231 58232-9912_60870e26-68a6-4bdc-b17e-79119d94d7c7 58232-9912 HUMAN OTC DRUG Aveeno Baby Essential Daily Care Baby and Mommy Gift Set Dimethicone, Avobenzone, Octinoxate, and Octisalate KIT 20121204 20180216 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. E 20171231 58232-9914_92d439dd-22ce-4eb6-a5b8-5e05b533d4f2 58232-9914 HUMAN OTC DRUG Aveeno Baby Mommy and Me Gift Set Zinc Oxide and Dimethicone KIT 20130510 20180218 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. N 20181231 58232-9915_ce22b2c3-b941-491e-932c-26af18260325 58232-9915 HUMAN OTC DRUG Johnsons Baby First Touch Gift Set Zinc Oxide KIT 20150707 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. N 20181231 58232-9916_962a76ac-698d-4a44-9d3e-f08cb675e814 58232-9916 HUMAN OTC DRUG Neosporin Plus Pain Relief Neo To Go First Aid Antibiotic Pain Relieving Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20130714 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 58232-9926_dfe934d0-a40e-4cdb-a440-50c6ee6a4a71 58232-9926 HUMAN OTC DRUG Desitin Rapid Relief Diaper Rash Zinc Oxide CREAM TOPICAL 20151020 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. ZINC OXIDE 130 mg/g N 20181231 58232-9927_be983d6d-999b-4014-a34f-ecd927a8c6d1 58232-9927 HUMAN OTC DRUG Desitin Maximum Strength Diaper Rash Zinc Oxide PASTE TOPICAL 20151116 20181001 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. ZINC OXIDE 400 mg/g N 20181231 58232-9928_caa8cac0-43f0-4056-a73c-ab75233a8110 58232-9928 HUMAN OTC DRUG RoC Multi Correxion 5 in 1 Chest, Neck and Face Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20150901 20190801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/g; mg/g; mg/g; mg/g N 20181231 58232-9929_0c28e6e1-e216-489b-8aad-2f7531aa23f8 58232-9929 HUMAN OTC DRUG Aveeno Active Naturals Ultra-Calming Daily Moisturizer Broad Spectrum SPF15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20151116 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL N 20181231 58232-9930_75d516c2-a378-467a-8b72-46dd628e3af7 58232-9930 HUMAN OTC DRUG Aveeno Active Naturals Positively Radiant Daily Moisturizer Broad Spectrum SPF15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20151113 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL N 20181231 58238-225_1e6017fb-3971-12da-e054-00144ff88e88 58238-225 HUMAN OTC DRUG DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20150320 OTC MONOGRAPH FINAL part341 Deliz Pharmaceutical Corp DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15; 30 mg/5mL; mg/5mL; mg/5mL N 20181231 58238-226_1e604922-9370-1e3f-e054-00144ff88e88 58238-226 HUMAN OTC DRUG DELTUSS DP Nasal Decongestant Antihistamine CHERRY Flavor DEXCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20150320 OTC MONOGRAPH FINAL part341 Deliz Pharmaceutical Corp DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 30 mg/5mL; mg/5mL N 20181231 58238-227_2da57080-f8ba-4bf4-e054-00144ff8d46c 58238-227 HUMAN OTC DRUG TRISPEC DMX Cough Suppressant Expectorant Peach Flavor DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20141118 OTC MONOGRAPH FINAL part341 Deliz Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 187 mg/5mL; mg/5mL N 20181231 58238-228_1e634506-88f2-53f0-e054-00144ff8d46c 58238-228 HUMAN OTC DRUG TRISPEC PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20150320 OTC MONOGRAPH FINAL part341 Deliz Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 187; 30 mg/5mL; mg/5mL; mg/5mL N 20181231 58238-229_3bb010da-0eb9-4a17-9280-2c14fc3bcef2 58238-229 HUMAN OTC DRUG TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20140227 OTC MONOGRAPH FINAL part341 Deliz Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 187 mg/5mL; mg/5mL E 20171231 58238-230_1e66114f-db78-443f-e054-00144ff8d46c 58238-230 HUMAN OTC DRUG TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID ORAL 20140227 OTC MONOGRAPH FINAL part341 Deliz Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 187; 30 mg/5mL; mg/5mL; mg/5mL N 20181231 58247-001_adfcb533-e96f-4b1d-b10e-950cee44127c 58247-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19810101 UNAPPROVED MEDICAL GAS Respitek Inc OXYGEN 99 L/100L N 20181231 58264-0001_310368cf-c4eb-4b12-bff1-6e683bd08beb 58264-0001 HUMAN OTC DRUG D1 APIS MELLIFERA, BELLADONNA LEAF, MERCURIC CHLORIDE, BARIUM CHLORIDE DIHYDRATE, LACHESIS MUTA VENOM, CALCIUM IODIDE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, TEUCRIUM MARUM, and PHYTOLACCA AMERICANA WHOLE SOLUTION SUBLINGUAL 19900101 UNAPPROVED HOMEOPATHIC DNA Labs, Inc. APIS MELLIFERA; BELLADONNA LEAF; MERCURIC CHLORIDE; BARIUM CHLORIDE DIHYDRATE; LACHESIS MUTA VENOM; CALCIUM IODIDE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; TEUCRIUM MARUM; PHYTOLACCA AMERICANA WHOLE 4; 4; 6; 6; 12; 6; 12; 4; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 58264-0002_908e4ffc-c159-41ba-97ff-5e972fb82195 58264-0002 HUMAN OTC DRUG D2 gold trichloride, crataegus laevigata whole, selenicereus grandiflorus whole, dibasic potassium phosphate, aconitum napellus, valeriana officinalis whole, spigelia anthelmia, arnica montana, digitalis purpurea whole, prunus laurocerasus whole, and strychnos ignatii whole SOLUTION SUBLINGUAL 19900101 UNAPPROVED HOMEOPATHIC DNA Labs, Inc. GOLD TRICHLORIDE; CRATAEGUS LAEVIGATA WHOLE; SELENICEREUS GRANDIFLORUS WHOLE; DIBASIC POTASSIUM PHOSPHATE; ACONITUM NAPELLUS; VALERIANA OFFICINALIS WHOLE; SPIGELIA ANTHELMIA; ARNICA MONTANA; DIGITALIS PURPUREA WHOLE; PRUNUS LAUROCERASUS WHOLE; STRYCHNOS IGNATII WHOLE 6; 1; 4; 4; 6; 3; 4; 4; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 58264-0003_476d8bed-d4bd-4695-ba0f-8fd80cd1af0d 58264-0003 HUMAN OTC DRUG D3 digitalis purpurea whole, strophanthus hispidus whole, crataegus mexicana whole, selenicereus grandiflorus whole, kalmia latifolia whole, arsenic trioxide, phosphorus, drimia maritima whole, spigelia anthelmia, and potassium carbonate SOLUTION SUBLINGUAL 19900101 UNAPPROVED HOMEOPATHIC DNA Labs, Inc. DIGITALIS PURPUREA WHOLE; STROPHANTHUS HISPIDUS WHOLE; CRATAEGUS MEXICANA WHOLE; SELENICEREUS GRANDIFLORUS WHOLE; KALMIA LATIFOLIA WHOLE; ARSENIC TRIOXIDE; PHOSPHORUS; DRIMIA MARITIMA WHOLE; SPIGELIA ANTHELMIA; POTASSIUM CARBONATE 4; 6; 1; 2; 3; 5; 5; 4; 3; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 58264-0007_63a6f56d-010e-484a-bdfd-8bcf807ddcbf 58264-0007 HUMAN OTC DRUG D7 STRYCHNOS NUX-VOMICA SEED, LYCOPODIUM CLAVATUM SPORE, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS WHOLE, CINCHONA OFFICINALIS WHOLE, MILK THISTLE, CITRULLUS COLOCYNTHIS WHOLE, and CHOLESTEROL SOLUTION SUBLINGUAL 19900101 UNAPPROVED HOMEOPATHIC DNA Labs, Inc. STRYCHNOS NUX-VOMICA SEED; LYCOPODIUM CLAVATUM SPORE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS WHOLE; MILK THISTLE; CITRULLUS COLOCYNTHIS WHOLE; CHOLESTEROL 4; 4; 3; 3; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 58264-0014_68a69130-9d7c-45f2-ae4f-4569c67d3f25 58264-0014 HUMAN OTC DRUG D14 Avena sativa whole, Valeriana officinalis whole, Humulus lupulus whole, Arabica coffee bean, Strychnos ignatii whole, zinc valerate dihydrate, Ammonium bromide, Chamomile, Eschscholzia Californica, and Passiflora incarnata whole SOLUTION SUBLINGUAL 19900101 UNAPPROVED HOMEOPATHIC DNA Labs, Inc. AVENA SATIVA WHOLE; VALERIANA OFFICINALIS WHOLE; HUMULUS LUPULUS WHOLE; ARABICA COFFEE BEAN; STRYCHNOS IGNATII WHOLE; ZINC VALERATE DIHYDRATE; AMMONIUM BROMIDE; CHAMOMILE; ESCHSCHOLZIA CALIFORNICA; PASSIFLORA INCARNATA WHOLE 1; 1; 2; 4; 6; 9; 3; 4; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 58264-0017_b91c042b-55de-4fe7-9b3d-8cfb700dcadb 58264-0017 HUMAN OTC DRUG D17 Naja Naja Whole, Scrophularia nodosa, Lactic Acid, DL-, and Radium bromide SOLUTION SUBLINGUAL 19900101 UNAPPROVED HOMEOPATHIC DNA Labs, Inc. NAJA NAJA WHOLE; SCROPHULARIA NODOSA; LACTIC ACID, DL-; RADIUM BROMIDE 30; 2; 4; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 58264-0056_bea576cd-7535-41ec-bc1c-0216b95cb33b 58264-0056 HUMAN OTC DRUG D56 artemisia cina pre-flowering top, tanacetum vulgare whole, artemisia vulgaris whole, dryopteris filix-mas root, mercuric chloride, and graphite SOLUTION SUBLINGUAL 19900101 UNAPPROVED HOMEOPATHIC DNA Labs, Inc. ARTEMISIA CINA PRE-FLOWERING TOP; TANACETUM VULGARE WHOLE; ARTEMISIA VULGARIS WHOLE; DRYOPTERIS FILIX-MAS ROOT; MERCURIC CHLORIDE; GRAPHITE 4; 1; 1; 2; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 58264-0083_3964a602-62ca-4038-aac1-01593f3dc660 58264-0083 HUMAN OTC DRUG D82 Achillea Millefolium, Arnica montana, Hypericum perforatum, Horse Chestnut, and Viscum Album Whole SOLUTION SUBLINGUAL 19900101 UNAPPROVED HOMEOPATHIC DNA Labs, Inc. ACHILLEA MILLEFOLIUM; ARNICA MONTANA; HYPERICUM PERFORATUM; HORSE CHESTNUT; VISCUM ALBUM WHOLE 3; 6; 3; 2; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 58264-0084_b540f668-1c15-44a8-be94-2d0b5960c1f4 58264-0084 HUMAN OTC DRUG D83 Candida albicans SOLUTION SUBLINGUAL 19900101 UNAPPROVED HOMEOPATHIC DNA Labs, Inc. CANDIDA ALBICANS 6 [hp_X]/mL N 20191231 58265-001_7a727f61-6c51-44a0-b30f-6d1a550fcdc1 58265-001 HUMAN OTC DRUG O24 Pain Neutralizer Camphor SPRAY TOPICAL 20071203 OTC MONOGRAPH NOT FINAL part348 O24 Naturals LLC CAMPHOR (NATURAL) 3.1 g/100mL E 20171231 58265-002_3f68c73c-a187-4825-ab9c-1f33bf67c585 58265-002 HUMAN OTC DRUG SierraSil Pain Relief Camphor SPRAY TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part348 O24 Naturals, LLC CAMPHOR (NATURAL) 3.1 g/100mL E 20171231 58268-013_7c7427a7-aa33-4103-b8d6-d79a6e70c58c 58268-013 HUMAN OTC DRUG Acnezzol Base Salicylic Acid LOTION TOPICAL 20130110 OTC MONOGRAPH FINAL part333D SOLUTION INTERNATIONAL INC SALICYLIC ACID 1 mg/mL E 20171231 58274-006_7bf04182-1afe-48b2-b03d-0c00dba86c0a 58274-006 HUMAN OTC DRUG Brush on Block Mineral Sunscreen Broad Spectrum SPF 30 Titanium Dioxide 15%, Zinc Oxide 12% CREAM TOPICAL 20130419 OTC MONOGRAPH NOT FINAL part352 SPF Ventures, LLC TITANIUM DIOXIDE; ZINC OXIDE 15; 12 g/100g; g/100g N 20181231 58274-007_bf379495-0f06-4e9e-acae-1226b660a88e 58274-007 HUMAN OTC DRUG Brush on Block Mineral Sunscreen Broad Spectrum SPF 30 Titanium Dioxide 15%, Zinc Oxide 12% POWDER TOPICAL 20151015 OTC MONOGRAPH NOT FINAL part352 SPF Ventures, LLC TITANIUM DIOXIDE; ZINC OXIDE 15; 12 g/100g; g/100g N 20181231 58276-015_546e67df-7709-4082-a917-3b044293a7b5 58276-015 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS McKnight Inc. dba McKnight Medical OXYGEN 99 L/100L N 20181231 58281-560_824b1807-be48-4239-bfdc-2d1d15b42c71 58281-560 HUMAN PRESCRIPTION DRUG Lioresal baclofen INJECTION INTRATHECAL 19920617 NDA NDA020075 Medtronic Neuromodulation BACLOFEN .5 mg/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 58281-561_824b1807-be48-4239-bfdc-2d1d15b42c71 58281-561 HUMAN PRESCRIPTION DRUG Lioresal baclofen INJECTION INTRATHECAL 19920617 NDA NDA020075 Medtronic Neuromodulation BACLOFEN 2 mg/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 58281-562_824b1807-be48-4239-bfdc-2d1d15b42c71 58281-562 HUMAN PRESCRIPTION DRUG Lioresal baclofen INJECTION INTRATHECAL 19961107 NDA NDA020075 Medtronic Neuromodulation BACLOFEN .05 mg/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 58281-563_824b1807-be48-4239-bfdc-2d1d15b42c71 58281-563 HUMAN PRESCRIPTION DRUG Lioresal baclofen INJECTION INTRATHECAL 20030508 NDA NDA020075 Medtronic Neuromodulation BACLOFEN 2 mg/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 58284-100_476d6991-1b02-4381-ba31-1bf5961477a8 58284-100 HUMAN PRESCRIPTION DRUG Probuphine buprenorphine hydrochloride IMPLANT SUBCUTANEOUS 20160609 NDA NDA204442 Braeburn Pharmaceuticals BUPRENORPHINE HYDROCHLORIDE 80 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 58291-0001_bdf47d89-486c-48bc-b9d9-e41c62ea9b38 58291-0001 HUMAN OTC DRUG DERM-APPLY GLYCERIN LIQUID TOPICAL 19890101 OTC MONOGRAPH FINAL part334 Snuva, Inc. GLYCERIN 30.78 mL/100mL E 20171231 58292-010_39c1b305-bbea-40d8-b1a8-59d04f7c3e5a 58292-010 HUMAN OTC DRUG NARAMIN DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20140528 OTC MONOGRAPH FINAL part341 National Pharma Industries Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 58292-011_476632b8-7a0a-742a-e054-00144ff88e88 58292-011 HUMAN OTC DRUG On The GO-Dose DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20140528 OTC MONOGRAPH FINAL part341 Perfect Measure LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 58301-010_d4115142-a2a6-45c8-b305-b5561dd7e326 58301-010 HUMAN OTC DRUG Colloidal Silver 30 PPM Argentum Met LIQUID ORAL 20090519 UNAPPROVED HOMEOPATHIC MBI Distributing Inc. SILVER 5 [hp_X]/240mL N 20181231 58301-020_9f72c0fc-d306-4453-a6e2-fc9b94cddc46 58301-020 HUMAN OTC DRUG Silver-Zinc Throat Acontium Nap, Aloe Vera, Argentum Met, Arnica, Arsenicum Alb, Belladonna, Calendula Officinalis, Cinnabaris, Hydrastis, Mentha Pip, Phosphorus, Zincum Sulf SPRAY ORAL 20090519 UNAPPROVED HOMEOPATHIC MBI Distributing Inc. SILVER; ALOE VERA LEAF; ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MERCURIC SULFIDE; GOLDENSEAL; MENTHA PIPERITA; PHOSPHORUS; ZINC SULFATE HEPTAHYDRATE 5; 4; 12; 4; 8; 12; 4; 12; 4; 4; 12; 4 [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL; [hp_X]/120mL N 20181231 58301-181_ca25ffb3-f69c-4d2c-aa94-525ef518df91 58301-181 HUMAN OTC DRUG Burn Aesculus hippocastanum, Aloe socotrina, Arnica montana, Berberis vulgaris, Calendula officinalis, Salicylicum acidum, Zincum metallicum SPRAY TOPICAL 20100901 UNAPPROVED HOMEOPATHIC MBI Distributing Inc. AESCULUS HIPPOCASTANUM FLOWER; ALOE; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; CALENDULA OFFICINALIS FLOWERING TOP; SALICYLIC ACID; ZINC SULFATE HEPTAHYDRATE 4; 4; 4; 4; 4; 2; 3 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL N 20181231 58310-001_e87b6186-7803-4739-b3f3-5abac6201078 58310-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140211 UNAPPROVED MEDICAL GAS Keeler's Medical Supply, Inc. OXYGEN 99 L/100L E 20171231 58311-2222_dd1b385f-d001-40d7-9cd7-5df991448fdf 58311-2222 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19650101 NDA NDA205767 Young Welding Supply, Inc OXYGEN 99 L/100L N 20181231 58311-4444_bbb0f38e-a551-402d-8a72-b4333970ca60 58311-4444 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19650101 NDA NDA205766 Young Welding Supply, Inc NITROGEN 99 L/100L N 20181231 58318-001_f24f73e7-0201-435b-b6c3-c6719826b26e 58318-001 HUMAN OTC DRUG Better Braids Medicated Salicylic Acid SHAMPOO TOPICAL 19930801 OTC MONOGRAPH FINAL part358H Keystone Laboratories SALICYLIC ACID .24 mg/355mL E 20171231 58318-002_3a988b2a-78e4-4250-bb4a-670403b086e1 58318-002 HUMAN OTC DRUG Ultra Glow Fade with Aloe Vera Hydroquinone, Padimate O CREAM TOPICAL 19640407 OTC MONOGRAPH NOT FINAL part358A Keystone Laboratories HYDROQUINONE; PADIMATE O 1; 1 g/57g; g/57g E 20171231 58318-003_626f5f92-05e4-5924-e053-2a91aa0ac58c 58318-003 HUMAN OTC DRUG Ultra Glow Fade Hydroquinone CREAM TOPICAL 20180110 OTC MONOGRAPH NOT FINAL part358A Keystone Laboratories HYDROQUINONE 1 g/51g N 20191231 58318-004_3daa3476-f1b2-7323-e054-00144ff8d46c 58318-004 HUMAN OTC DRUG Better Braids Medicated Un-Braid Medicated Salicylic Acid SPRAY TOPICAL 20160916 OTC MONOGRAPH FINAL part358H Keystone Laboratories SALICYLIC ACID 2 mg/355mL E 20171231 58318-005_3d1c75b9-2514-280d-e054-00144ff88e88 58318-005 HUMAN OTC DRUG Better Braids Medicated Leave in Conditioner Medicated Salicylic Acid SPRAY TOPICAL 20160916 OTC MONOGRAPH FINAL part358H Keystone Laboratories SALICYLIC ACID 2 mg/355mL E 20171231 58318-006_3d42beb6-533d-646b-e054-00144ff88e88 58318-006 HUMAN OTC DRUG Better Braids Medicated Salicylic Acid SPRAY TOPICAL 20160916 OTC MONOGRAPH FINAL part358H Keystone Laboratories SALICYLIC ACID 2 mg/355mL E 20171231 58318-007_3dc0e128-ae3e-28e0-e054-00144ff88e88 58318-007 HUMAN OTC DRUG Better Braids Medicated Medicated Salicylic Acid SPRAY TOPICAL 20160916 OTC MONOGRAPH FINAL part358H Keystone Laboratories SALICYLIC ACID 2 mg/355mL E 20171231 58318-008_61f59bc5-2f47-764a-e053-2991aa0acb19 58318-008 HUMAN OTC DRUG Ultra Glow Fade Hydroquinone CREAM TOPICAL 20180104 OTC MONOGRAPH NOT FINAL part358A Keystone Laboratories HYDROQUINONE; PADIMATE O 2; 1.5 g/102g; g/102g N 20191231 58331-030_78c54786-6377-468f-957b-2d62a5a100e9 58331-030 HUMAN OTC DRUG Croc Bloc Broad Spectrum SPF 30 FPS Ecran Solaire HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, and Avobenzone LOTION TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part352 Degil Safety Products (1989) Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 10.5; 5; 2; 2; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 58331-050_3fd5c8dd-33b8-46d4-b431-e457f80ff6b9 58331-050 HUMAN OTC DRUG Croc Bloc Broad Spectrum SPF 50 FPS Ecran Solaire HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, AND AVOBENZONE LOTION TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part352 Degil Safety Products (1989) Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 13; 5; 7; 4; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 58350-000_9777bbcb-7ad0-4cf6-9864-026ea343b125 58350-000 HUMAN OTC DRUG Superior Analgesic Superior Analgesic LINIMENT TRANSDERMAL 20091228 OTC MONOGRAPH FINAL part346 Superior Trading Company MENTHOL 3.5 mg/100mL E 20171231 58354-100_76daffb5-71ec-463f-aae0-c7920acef51d 58354-100 HUMAN OTC DRUG Galeo Dihydroxydibutylether LIQUID ORAL 20170228 UNAPPROVED DRUG OTHER Cho-A Pharm.Co.,Ltd. 4,4'-OXYDI-2-BUTANOL 5 g/50mL N 20181231 58354-101_bcdeaf1a-6dcd-4ebe-b50a-b4bc91aa418f 58354-101 HUMAN OTC DRUG Zantanol Tab. MAGNESIUM OXIDE, Magnesium Aluminum Hydrate TABLET ORAL 20170228 OTC MONOGRAPH FINAL part331 Cho-A Pharm.Co.,Ltd. MAGNESIUM OXIDE; MAGALDRATE 50; 50 mg/424mg; mg/424mg N 20181231 58354-102_04de7f72-11e6-4e97-83f5-847f5ae74235 58354-102 HUMAN OTC DRUG Elas gel TROXERUTIN, GINKGO LOTION TOPICAL 20170228 UNAPPROVED DRUG OTHER Cho-A Pharm.Co.,Ltd. GINKGO; TROXERUTIN 140; 3000 mg/100g; mg/100g N 20181231 58354-103_28bcc3b9-adee-4daf-8dbe-77d7c650b3ab 58354-103 HUMAN OTC DRUG Colcol-Eunkyo Cap. Lonicera Flower, Forsythia Fruit, Mentha Herb, Platycodon Root CAPSULE ORAL 20170301 UNAPPROVED DRUG OTHER Cho-A Pharm.Co.,Ltd. LONICERA CONFUSA FLOWER; FORSYTHIA SUSPENSA FRUIT; MENTHA ARVENSIS TOP; PLATYCODON GRANDIFLORUS ROOT 105.6; 105.6; 63.3; 63.3 mg/610mg; mg/610mg; mg/610mg; mg/610mg N 20181231 58354-104_616f6295-457a-efa5-e053-2991aa0a7dad 58354-104 HUMAN OTC DRUG Cho-A Point Plaster Methyl Salicylate, L-Menthol, dl-Camphor PATCH TOPICAL 20171228 OTC MONOGRAPH NOT FINAL part348 Cho-A Pharm.Co.,Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 1.108; 2.769; 5.541 mg/67.15mg; mg/67.15mg; mg/67.15mg N 20181231 58354-105_617a319f-05e2-46e6-e053-2a91aa0a8467 58354-105 HUMAN OTC DRUG See Clean-One Eye Drops Boric acid LIQUID OPHTHALMIC 20171229 UNAPPROVED DRUG OTHER Cho-A Pharm.Co.,Ltd. BORIC ACID 21.644 mg/14mL N 20181231 58356-001_afc295bc-8fad-4f9b-9ff3-9007045c7805 58356-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19850101 NDA NDA205767 Lampton Welding Supply Company, Inc OXYGEN 99 L/100L N 20181231 58356-002_4447ee78-ae9e-40fc-836c-50db23a6cd8f 58356-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19850101 NDA NDA205766 Lampton Welding Supply Company, Inc NITROGEN 99 L/100L N 20181231 58368-001_2ab97b8c-6085-4230-a25e-9219eeab6e04 58368-001 HUMAN OTC DRUG NeoRelief Actaea Spicata Root, Horse Chestnut, ALTHAEA OFFICINALIS ROOT, ARNICA MONTANA, ATROPA BELLADONNA ROOT, BELLIS PERENNIS, BRYONIA ALBA ROOT, CALENDULA OFFICINALIS FLOWERING TOP, CAULOPHYLLUM THALICTROIDES ROOT, CAUSTICUM, BLACK COHOSH, GUAIACUM OFFICINALE RESIN, HYPERICUM PERFORATUM, POTASSIUM CARBONATE, LEDUM PALUSTRE TWIG, LITHIUM CARBONATE, FRANGULA CALIFORNICA BARK, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SALICYLIC ACID, and STELLARIA MEDIA GEL TOPICAL 20131101 UNAPPROVED HOMEOPATHIC Biolyte Laboratories, LLC ACTAEA SPICATA ROOT; HORSE CHESTNUT; ALTHAEA OFFICINALIS ROOT; ARNICA MONTANA; ATROPA BELLADONNA ROOT; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; BLACK COHOSH; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; FRANGULA CALIFORNICA BARK; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; STELLARIA MEDIA 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 58368-002_46da3f0e-9dd0-6495-e054-00144ff8d46c 58368-002 HUMAN OTC DRUG NeoRelief for Muscle Crampling and Restlessness Topical Gel for Muscle Cramping and Restlessness GEL TOPICAL 20170201 UNAPPROVED HOMEOPATHIC BioLyte Laboratories, LLC CAUSTICUM; JATROPHA CURCAS SEED; FRANGULA CALIFORNICA BARK; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA; ATROPA BELLADONNA ROOT; BLACK COHOSH; ARTEMISIA CINA FLOWER; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SCUTELLARIA LATERIFLORA; TARAXACUM OFFICINALE; VALERIAN; VERATRUM ALBUM ROOT 4; 8; 4; 4; 4; 4; 4; 8; 4; 4; 4; 4; 4; 4; 4; 4; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 58368-005_46de9e08-068d-5817-e054-00144ff8d46c 58368-005 HUMAN OTC DRUG NeoRelief for Pain Topical Gel for Pain GEL TOPICAL 20170201 UNAPPROVED HOMEOPATHIC BioLyte Laboratories, LLC BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; GUAIACUM OFFICINALE RESIN; HYPERICUM PERFORATUM; CALCIUM CARBONATE; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; FRANGULA CALIFORNICA BARK; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; HORSE CHESTNUT; SALICYLIC ACID; BLACK COHOSH; STELLARIA MEDIA; ACTAEA SPICATA ROOT; ALTHAEA OFFICINALIS ROOT; ARNICA MONTANA; ATROPA BELLADONNA ROOT 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 58370-1001_cd5177f9-bbce-46de-a285-72a3a96cb3a4 58370-1001 HUMAN OTC DRUG SOMA Anti-Cancergen ASIAN GINSENG POWDER ORAL 20130306 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd ASIAN GINSENG 5.67 g/100g E 20171231 58370-1010_c1f7eaa0-af93-4bbc-a39f-63dc5fd9d4ac 58370-1010 HUMAN OTC DRUG SOMA Circum CLOVE PILL ORAL 20130506 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd CLOVE .0275 g/g E 20171231 58370-1011_e075a7c8-14e3-4265-8e0f-906f1bde2bcd 58370-1011 HUMAN OTC DRUG SOMA Prouri CLOVE PILL ORAL 20130506 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd CLOVE .0275 g/g E 20171231 58370-1012_c45c6f94-84ad-417d-bb51-810c5e06282e 58370-1012 HUMAN OTC DRUG SOMA Croim CLOVE PILL ORAL 20130506 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd CLOVE .0275 g/g E 20171231 58370-1013_f2ad0f05-9980-4d3d-8f43-24fd01d69e6d 58370-1013 HUMAN OTC DRUG SOMA Hyulgihwan Gold CLOVE PILL ORAL 20131114 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd ASIAN GINSENG .0567 g/g E 20171231 58370-2001_0ca43fcf-b0e0-499a-adc2-4ee56c0e80ac 58370-2001 HUMAN OTC DRUG SOMA Hyulgihwan ASIAN GINSENG POWDER ORAL 20130429 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd ASIAN GINSENG 5.67 g/100g E 20171231 58370-3001_ed857f19-7804-4cd3-9cd1-ce2ad2b70f7f 58370-3001 HUMAN OTC DRUG SOMA Pet-circle ASIAN GINSENG POWDER ORAL 20130429 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd ASIAN GINSENG 5.67 g/100g E 20171231 58370-4001_12ec6b49-500b-46be-9388-dfd139bda24a 58370-4001 HUMAN OTC DRUG SOMA Disordergen ASIAN GINSENG PILL ORAL 20130502 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd TRAMETES VERSICOLOR FRUITING BODY .05 g/g E 20171231 58370-5001_7d3c5669-f009-4135-af1e-6e5c90c58230 58370-5001 HUMAN OTC DRUG SOMA Diat TRAMETES VERSICOLOR FRUITING BODY PILL ORAL 20130505 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd TRAMETES VERSICOLOR FRUITING BODY .05 g/g E 20171231 58370-6001_44e3331e-5454-4c2f-9a04-81a3da3e216f 58370-6001 HUMAN OTC DRUG SOMA Heart-Q TRAMETES VERSICOLOR FRUITING BODY PILL ORAL 20130505 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd TRAMETES VERSICOLOR FRUITING BODY .05 g/g E 20171231 58370-7001_821ff8bc-fb42-406c-8e92-9b44121b201b 58370-7001 HUMAN OTC DRUG SOMA Atocell TRAMETES VERSICOLOR FRUITING BODY PILL ORAL 20130505 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd TRAMETES VERSICOLOR FRUITING BODY .05 g/g E 20171231 58370-8001_7adef91f-9fc8-48d8-9fc2-800bc10eacac 58370-8001 HUMAN OTC DRUG SOMA Arthrit TRAMETES VERSICOLOR FRUITING BODY PILL ORAL 20130506 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd TRAMETES VERSICOLOR FRUITING BODY .05 g/g E 20171231 58370-9001_b8d0edab-8734-40f7-8083-e92e75222b2b 58370-9001 HUMAN OTC DRUG SOMA Hepati TRAMETES VERSICOLOR FRUITING BODY PILL ORAL 20130506 UNAPPROVED DRUG OTHER SOMA Biotechnology Co., Ltd TRAMETES VERSICOLOR FRUITING BODY .05 g/g E 20171231 58381-001_490ecc1d-df20-7489-e054-00144ff88e88 58381-001 HUMAN PRESCRIPTION DRUG Oxygen, Compressed OXYGEN GAS RESPIRATORY (INHALATION) 20130606 UNAPPROVED MEDICAL GAS Pulmocare Respiratory Services, Inc. OXYGEN 1 L/L N 20181231 58394-012_72acb4c2-2341-4297-926e-f03c01a4a379 58394-012 PLASMA DERIVATIVE Xyntha antihemophilic factor (recombinant) KIT 20080801 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-013_72acb4c2-2341-4297-926e-f03c01a4a379 58394-013 PLASMA DERIVATIVE Xyntha antihemophilic factor (recombinant) KIT 20080801 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-014_72acb4c2-2341-4297-926e-f03c01a4a379 58394-014 PLASMA DERIVATIVE Xyntha antihemophilic factor (recombinant) KIT 20080801 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-015_72acb4c2-2341-4297-926e-f03c01a4a379 58394-015 PLASMA DERIVATIVE Xyntha antihemophilic factor (recombinant) KIT 20080801 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-016_8c817e4d-6801-4e1f-b42e-746da79a8dc8 58394-016 PLASMA DERIVATIVE Xyntha antihemophilic factor (recombinant) KIT 20100813 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-022_8c817e4d-6801-4e1f-b42e-746da79a8dc8 58394-022 PLASMA DERIVATIVE Xyntha antihemophilic factor (recombinant) KIT 20111201 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-023_8c817e4d-6801-4e1f-b42e-746da79a8dc8 58394-023 PLASMA DERIVATIVE Xyntha antihemophilic factor (recombinant) KIT 20111201 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-024_8c817e4d-6801-4e1f-b42e-746da79a8dc8 58394-024 PLASMA DERIVATIVE Xyntha antihemophilic factor (recombinant) KIT 20110801 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-025_8c817e4d-6801-4e1f-b42e-746da79a8dc8 58394-025 PLASMA DERIVATIVE Xyntha antihemophilic factor (recombinant) KIT 20110801 BLA BLA125264 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-633_783a9fed-a4e2-4e32-adb1-4378f244d6d0 58394-633 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 19970201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-634_783a9fed-a4e2-4e32-adb1-4378f244d6d0 58394-634 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 19970201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-635_783a9fed-a4e2-4e32-adb1-4378f244d6d0 58394-635 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 19970201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-636_783a9fed-a4e2-4e32-adb1-4378f244d6d0 58394-636 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 19970201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58394-637_783a9fed-a4e2-4e32-adb1-4378f244d6d0 58394-637 PLASMA DERIVATIVE BeneFIX coagulation factor ix (recombinant) KIT 20120201 BLA BLA103677 Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. N 20181231 58399-1001_2fd4e561-efc9-4704-81a6-3f98069e7f45 58399-1001 HUMAN OTC DRUG Aquapick Whitening Bubblepick SODIUM FLUORIDE LIQUID DENTAL 20130502 OTC MONOGRAPH FINAL part355 Aquapick Co., Ltd SODIUM FLUORIDE .001 mg/mL E 20171231 58399-2001_1c95109f-ac5d-49dc-bc5a-52a16d75d074 58399-2001 HUMAN OTC DRUG Aquapick Whitening Tooth Foam SODIUM FLUORIDE LIQUID DENTAL 20130502 OTC MONOGRAPH FINAL part355 Aquapick Co., Ltd SODIUM FLUORIDE .001 mg/mL E 20171231 58400-001_2c423fa7-e053-45d1-bfd5-6efd580be58a 58400-001 HUMAN OTC DRUG Micronized Benzoyl Peroxide Treatment Benzoyl Peroxide GEL TOPICAL 20120601 OTC MONOGRAPH FINAL part333D Pharmco Laboratories Inc. BENZOYL PEROXIDE 25 mg/g N 20181231 58400-002_808d5869-24f5-4545-81cc-a4ea719e6601 58400-002 HUMAN OTC DRUG Micronized Benzoyl Peroxide Treatment Benzoyl Peroxide GEL TOPICAL 20120601 OTC MONOGRAPH FINAL part333D Pharmco Laboratories Inc. BENZOYL PEROXIDE 50 mg/g E 20171231 58400-003_af009b8c-1d85-463b-88ad-2a1be01a315b 58400-003 HUMAN OTC DRUG Micronized Benzoyl Peroxide Treatment Benzoyl Peroxide GEL TOPICAL 20120601 OTC MONOGRAPH FINAL part333D Pharmco Laboratories Inc. BENZOYL PEROXIDE 100 mg/g N 20181231 58400-004_d5d58791-3291-47ef-8761-e6e58884ffc2 58400-004 HUMAN OTC DRUG Micronized BPO Wash Benzoyl Peroxide GEL TOPICAL 20120601 OTC MONOGRAPH FINAL part333D Pharmco Laboratories Inc. BENZOYL PEROXIDE 50 mg/g E 20171231 58400-005_b4867eeb-5f69-4208-a356-b8b88a34f5de 58400-005 HUMAN OTC DRUG Micronized BPO Scrub Benzoyl Peroxide GEL TOPICAL 20120601 OTC MONOGRAPH FINAL part333D Pharmco Laboratories Inc. BENZOYL PEROXIDE 50 mg/g E 20171231 58400-006_b06a287c-abf8-49d1-8beb-cc7e6dd604a6 58400-006 HUMAN OTC DRUG Anti-Aging Day Protect SPF 22 Octinoxate, Octisalate, and Avobenzone LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Pharmco Laboratories Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 75; 50; 20 mg/g; mg/g; mg/g N 20181231 58400-007_f94aff8f-dae4-4b59-a519-12706799e4cd 58400-007 HUMAN OTC DRUG Daily Facial Moisturizer SPF 35 Octinoxate and Avobenzone LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Pharmco Laboratories Inc. OCTINOXATE; AVOBENZONE 40; 25 mg/g; mg/g N 20181231 58400-009_c7536605-ccc4-4ead-b3be-67c65fc39e84 58400-009 HUMAN OTC DRUG Benzoyl Peroxide Cleanser Benzoyl Peroxide GEL TOPICAL 20161201 OTC MONOGRAPH FINAL part333D Pharmco Laboratories Inc. BENZOYL PEROXIDE 35 mg/g N 20181231 58404-001_795bc362-461d-46ba-9eef-4b96857f39b2 58404-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130501 NDA NDA205865 Industrial Welding & Tool Supply, Ltd. OXYGEN 995 mL/L N 20181231 58404-002_4c303a04-350b-45f9-8699-9867a29131fc 58404-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20130501 NDA NDA205866 Industrial Welding & Tool Supply, Ltd. NITROGEN 995 mL/L N 20181231 58406-425_0197763d-92cc-4a02-b3da-dd7793adb18e 58406-425 HUMAN PRESCRIPTION DRUG ENBREL etanercept KIT 20030102 BLA BLA103795 Immunex Corporation N 20181231 58406-435_0197763d-92cc-4a02-b3da-dd7793adb18e 58406-435 HUMAN PRESCRIPTION DRUG ENBREL etanercept SOLUTION SUBCUTANEOUS 20051006 BLA BLA103795 Immunex Corporation ETANERCEPT 50 mg/mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] N 20181231 58406-445_0197763d-92cc-4a02-b3da-dd7793adb18e 58406-445 HUMAN PRESCRIPTION DRUG ENBREL etanercept SOLUTION SUBCUTANEOUS 20051110 BLA BLA103795 Immunex Corporation ETANERCEPT 50 mg/mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] N 20181231 58406-446_0197763d-92cc-4a02-b3da-dd7793adb18e 58406-446 HUMAN PRESCRIPTION DRUG ENBREL etanercept SOLUTION SUBCUTANEOUS 20171020 BLA BLA103795 Immunex Corporation ETANERCEPT 50 mg/mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] N 20181231 58406-455_0197763d-92cc-4a02-b3da-dd7793adb18e 58406-455 HUMAN PRESCRIPTION DRUG ENBREL etanercept SOLUTION SUBCUTANEOUS 20051110 BLA BLA103795 Immunex Corporation ETANERCEPT 25 mg/.5mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] N 20181231 58406-456_0197763d-92cc-4a02-b3da-dd7793adb18e 58406-456 HUMAN PRESCRIPTION DRUG ENBREL etanercept SOLUTION SUBCUTANEOUS 20170929 BLA BLA103795 Immunex Corporation ETANERCEPT 50 mg/mL Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA] N 20181231 58407-025_6eb82a3c-0754-4e85-ac57-9e0064dfd5d4 58407-025 HUMAN OTC DRUG AHIST CHLORCYCLIZINE HYDROCHLORIDE TABLET ORAL 20130115 OTC MONOGRAPH NOT FINAL part341 Magna Pharmaceutcals, Inc. CHLORCYCLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 58407-510_ef6988f1-4db6-4015-8c45-4b69f9bbcca0 58407-510 HUMAN PRESCRIPTION DRUG ZolpiMIST Zolpidem Tartrate SPRAY, METERED ORAL 20160321 NDA NDA022196 Magna Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 58407-624_eb16e7b6-485d-47d1-ab04-90b65677fa48 58407-624 HUMAN OTC DRUG Stahist AD Chlorcyclizine Hydrochloride and Pseudoephedrine Hydrochloride LIQUID ORAL 20120401 OTC MONOGRAPH FINAL part341 MAGNA Pharmaceuticals, Inc. CHLORCYCLIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 25; 60 mg/5mL; mg/5mL N 20181231 58407-625_cc22074a-f1c7-4e69-bfad-839de3f52505 58407-625 HUMAN OTC DRUG STAHIST AD CHLORCYCLIZINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE TABLET ORAL 20111220 OTC MONOGRAPH FINAL part341 Magna Pharmaceuticals, Inc. CHLORCYCLIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 25; 60 mg/1; mg/1 N 20181231 58411-101_538734fc-a5ff-49dc-a2c6-923bdb1a00a7 58411-101 HUMAN OTC DRUG SHISEIDO IBUKI PROTECTIVE MOISTURIZER AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1903; 5633; 1522; 761 mg/76.12g; mg/76.12g; mg/76.12g; mg/76.12g N 20181231 58411-102_f92d4ece-9030-45da-aa54-97557cac8bd1 58411-102 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1255; 3715; 1004 mg/50.2g; mg/50.2g; mg/50.2g N 20181231 58411-103_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-103 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION I00 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-104_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-104 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION I20 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-105_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-105 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION I40 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-106_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-106 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION I60 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-107_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-107 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION I100 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-108_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-108 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION B00 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-109_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-109 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-110_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-110 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION B40 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-111_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-111 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION B60 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-112_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-112 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION B100 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-113_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-113 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION O00 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-114_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-114 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-115_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-115 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-116_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-116 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-117_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-117 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION O80 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-118_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-118 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION D10 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-119_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-119 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION D20 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-120_3cf2625b-c5ef-4f08-b03c-0a5d7f1750e1 58411-120 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT FOUNDATION D30 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 948; 1700 mg/32.7g; mg/32.7g N 20181231 58411-121_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-121 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g N 20181231 58411-122_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-122 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT BEIGE OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g N 20181231 58411-123_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-123 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT IVORY OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g N 20181231 58411-124_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-124 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT OCHRE OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g N 20181231 58411-125_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-125 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM BEIGE OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g N 20181231 58411-126_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-126 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM IVORY OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g N 20181231 58411-127_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-127 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM OCHRE OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g N 20181231 58411-128_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-128 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK BEIGE OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g N 20181231 58411-129_a4acb1f6-81a0-4ed9-8033-78af86dd276a 58411-129 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK IVORY OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 888; 600; 1416 mg/12g; mg/12g; mg/12g N 20181231 58411-130_129de1c1-1714-4212-b53b-c7dccc6662ec 58411-130 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION LIGHT BEIGE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g N 20181231 58411-131_129de1c1-1714-4212-b53b-c7dccc6662ec 58411-131 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION LIGHT IVORY OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g N 20181231 58411-132_129de1c1-1714-4212-b53b-c7dccc6662ec 58411-132 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION LIGHT OCHRE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g N 20181231 58411-133_129de1c1-1714-4212-b53b-c7dccc6662ec 58411-133 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION MEDIUM BEIGE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g N 20181231 58411-134_129de1c1-1714-4212-b53b-c7dccc6662ec 58411-134 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION MEDIUM IVORY OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g N 20181231 58411-135_129de1c1-1714-4212-b53b-c7dccc6662ec 58411-135 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION DARK BEIGE OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g N 20181231 58411-136_129de1c1-1714-4212-b53b-c7dccc6662ec 58411-136 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION DARK IVORY OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 644; 2814 mg/33.9g; mg/33.9g N 20181231 58411-137_6b1eafce-16a6-41e5-ae0b-85ca81625d3f 58411-137 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 261; 648 mg/9g; mg/9g N 20181231 58411-138_6b1eafce-16a6-41e5-ae0b-85ca81625d3f 58411-138 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION FAIR OCHRE OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 261; 648 mg/9g; mg/9g N 20181231 58411-139_6b1eafce-16a6-41e5-ae0b-85ca81625d3f 58411-139 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION BEIGE OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 261; 648 mg/9g; mg/9g N 20181231 58411-140_6b1eafce-16a6-41e5-ae0b-85ca81625d3f 58411-140 HUMAN OTC DRUG SHISEIDO UV PROTECTIVE FOUNDATION OCHRE OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 261; 648 mg/9g; mg/9g N 20181231 58411-141_eb7b9e3d-9e11-4aae-bb1a-126eb197c71c 58411-141 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL PROTECTIVE AVOBENZONE, OCTINOXATE, and OCTOCRYLENE EMULSION TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1896; 5611; 1517 mg/75.83g; mg/75.83g; mg/75.83g N 20181231 58411-142_778c8b06-fe53-41ae-8c89-408c270dd2c4 58411-142 HUMAN OTC DRUG SHISEIDO ULTIMATE SUN PROTECTION AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE SPRAY TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.98; 19.89; 6.63; 3.32; 6.63 mg/132.6g; mg/132.6g; mg/132.6g; mg/132.6g; mg/132.6g N 20181231 58411-143_bf72a6f6-ead7-404c-8f8e-130cbac8c7d6 58411-143 HUMAN OTC DRUG CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE EMULSION TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3163; 9361; 2530; 1265 mg/126.5g; mg/126.5g; mg/126.5g; mg/126.5g N 20181231 58411-144_ed796daa-6bc5-4691-a17b-8a7bf67d9829 58411-144 HUMAN OTC DRUG CLE DE PEAU BEAUTE GENTLE PROTECTIVE I AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE EMULSION TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3163; 9361; 2530; 1265 mg/126.5g; mg/126.5g; mg/126.5g; mg/126.5g N 20181231 58411-145_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-145 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L BF20 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g N 20181231 58411-146_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-146 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L I10 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g N 20181231 58411-147_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-147 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L O10 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g N 20181231 58411-148_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-148 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L O20 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g N 20181231 58411-149_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-149 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L O30 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g N 20181231 58411-150_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-150 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L B10 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g N 20181231 58411-151_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-151 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L B20 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g N 20181231 58411-152_ebadc1fb-8c38-4ac6-b082-f09803fa43c7 58411-152 HUMAN OTC DRUG CLE DE PEAU BEAUTE FOUNDATION L B30 Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 656 mg/31.25g N 20181231 58411-153_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-153 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I BF20 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g N 20181231 58411-154_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-154 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I I10 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g N 20181231 58411-155_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-155 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I O10 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g N 20181231 58411-156_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-156 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I O20 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g N 20181231 58411-157_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-157 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I O30 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g N 20181231 58411-158_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-158 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I B10 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g N 20181231 58411-159_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-159 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I B20 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g N 20181231 58411-160_d3f4b615-9ab7-42b9-b768-ef332057b0a6 58411-160 HUMAN OTC DRUG CLE DE PEAU BEAUTE SILKY FOUNDATION I B30 Octinoxate and Titanium dioxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 539; 1.16 mg/28.35g; g/28.35g N 20181231 58411-161_d78a1818-e592-454c-9cc0-f8d3c4d0314c 58411-161 HUMAN OTC DRUG SHISEIDO SUN PROTECTION OCTINOXATE and TITANIUM DIOXIDE STICK TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 441; 828 mg/9g; mg/9g N 20181231 58411-162_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-162 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I00 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-163_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-163 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I20 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-164_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-164 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I40 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-165_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-165 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I60 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-166_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-166 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B20 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-167_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-167 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B40 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-168_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-168 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B60 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-169_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-169 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O20 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-170_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-170 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O40 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-171_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-171 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O60 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-172_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-172 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O80 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-173_1f7bc918-4956-4c23-b15d-f2c941f0a257 58411-173 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) O00 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-174_deb54724-c0bb-4d9c-9d39-d3daf1aa4df4 58411-174 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B00 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-175_deb54724-c0bb-4d9c-9d39-d3daf1aa4df4 58411-175 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B100 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-176_deb54724-c0bb-4d9c-9d39-d3daf1aa4df4 58411-176 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I100 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-177_deb54724-c0bb-4d9c-9d39-d3daf1aa4df4 58411-177 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) WB40 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-178_deb54724-c0bb-4d9c-9d39-d3daf1aa4df4 58411-178 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) WB60 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 540 mg/12g N 20181231 58411-179_5cb5d807-a8ef-4e40-9013-26f8b2dea937 58411-179 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D10 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 864 mg/12g N 20181231 58411-180_5cb5d807-a8ef-4e40-9013-26f8b2dea937 58411-180 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D20 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 864 mg/12g N 20181231 58411-181_5cb5d807-a8ef-4e40-9013-26f8b2dea937 58411-181 HUMAN OTC DRUG SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D30 Titanium dioxide POWDER TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 864 mg/12g N 20181231 58411-182_c987ab6d-007b-48f1-a590-fae85b97c372 58411-182 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I00 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g N 20181231 58411-183_c987ab6d-007b-48f1-a590-fae85b97c372 58411-183 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I20 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g N 20181231 58411-184_c987ab6d-007b-48f1-a590-fae85b97c372 58411-184 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I40 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g N 20181231 58411-185_c987ab6d-007b-48f1-a590-fae85b97c372 58411-185 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION I60 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g N 20181231 58411-186_c987ab6d-007b-48f1-a590-fae85b97c372 58411-186 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION B20 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g N 20181231 58411-187_c987ab6d-007b-48f1-a590-fae85b97c372 58411-187 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION B40 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g N 20181231 58411-188_c987ab6d-007b-48f1-a590-fae85b97c372 58411-188 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION B60 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g N 20181231 58411-189_c987ab6d-007b-48f1-a590-fae85b97c372 58411-189 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION O20 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g N 20181231 58411-190_c987ab6d-007b-48f1-a590-fae85b97c372 58411-190 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION O40 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g N 20181231 58411-191_c987ab6d-007b-48f1-a590-fae85b97c372 58411-191 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION O60 Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 410 mg/10g N 20181231 58411-192_443524d5-652f-454d-8a7c-57ff1aec892d 58411-192 HUMAN OTC DRUG SHISEIDO THE MAKEUP FOUNDATION Control Color Titanium dioxide STICK TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 250 mg/10g N 20181231 58411-193_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-193 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION I10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL N 20181231 58411-194_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-194 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL N 20181231 58411-195_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-195 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL N 20181231 58411-196_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-196 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL N 20181231 58411-197_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-197 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL N 20181231 58411-198_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-198 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O50 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL N 20181231 58411-199_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-199 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL N 20181231 58411-200_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-200 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL N 20181231 58411-201_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-201 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL N 20181231 58411-202_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-202 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL N 20181231 58411-203_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-203 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL N 20181231 58411-204_77706d40-8e4f-4922-8a45-7d4884a5d48b 58411-204 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION WB20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1617; 825 mg/30mL; mg/30mL N 20181231 58411-205_86a26d44-1211-48ea-9e37-f85a1180db1d 58411-205 HUMAN OTC DRUG CLE DE PEAU BEAUTE CORRECTING VEIL ENSULIZOLE, OCTINOXATE, and TITANIUM DIOXIDE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION ENSULIZOLE; OCTINOXATE; TITANIUM DIOXIDE 397; 1153; 954 mg/36mL; mg/36mL; mg/36mL N 20181231 58411-206_d44e2791-ad0e-43ca-b013-3f9ab0132fea 58411-206 HUMAN OTC DRUG CLE DE PEAU BEAUTE SHEER FLUID VEIL AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 771; 2282; 617 mg/30mL; mg/30mL; mg/30mL N 20181231 58411-207_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-207 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I00 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-208_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-208 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I20 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-209_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-209 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I40 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-210_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-210 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I60 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-211_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-211 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) I100 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-212_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-212 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) B00 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-213_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-213 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) B20 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-214_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-214 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) B40 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-215_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-215 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) B60 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-216_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-216 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) B100 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-217_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-217 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) O00 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-218_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-218 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) O20 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-219_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-219 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) O40 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-220_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-220 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) O60 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-221_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-221 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) O80 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-222_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-222 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) D10 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-223_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-223 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) D20 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-224_454e7e69-ebd5-4f8e-92cc-2ffb06cb42f4 58411-224 HUMAN OTC DRUG SHISEIDO SHEER AND PERFECT COMPACT (REFILL) D30 OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 290; 200; 620 mg/10g; mg/10g; mg/10g N 20181231 58411-225_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-225 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION I00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL N 20181231 58411-226_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-226 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION I20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL N 20181231 58411-227_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-227 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION I40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL N 20181231 58411-228_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-228 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION I60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL N 20181231 58411-229_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-229 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL N 20181231 58411-230_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-230 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION B40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL N 20181231 58411-231_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-231 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION B60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL N 20181231 58411-232_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-232 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION O00 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL N 20181231 58411-233_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-233 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL N 20181231 58411-234_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-234 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL N 20181231 58411-235_a124ee84-5f48-4fe7-ad7e-b4844a255232 58411-235 HUMAN OTC DRUG SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1023; 1023 mg/30mL; mg/30mL N 20181231 58411-236_7fa8e782-cd79-4c07-b179-4eb3a28fab31 58411-236 HUMAN OTC DRUG CLE DE PEAU BEAUTE HAND AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1191; 5656; 1529 mg/75mL; mg/75mL; mg/75mL N 20181231 58411-237_175aab9c-07ac-45a4-8371-0f1c53da6f6e 58411-237 HUMAN OTC DRUG CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER n AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 518; 1532; 414 mg/20mL; mg/20mL; mg/20mL N 20181231 58411-238_cf153a6d-e64a-4d1e-8e98-df1a70d0ec79 58411-238 HUMAN OTC DRUG SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1273; 3767; 1527 mg/50mL; mg/50mL; mg/50mL N 20181231 58411-239_0393c4a6-1123-4871-b42f-d8f72914921b 58411-239 HUMAN OTC DRUG SHISEIDO GLOW ENHANCING PRIMER AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 773; 2287; 927; 309 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 58411-241_6724c9df-66db-4bc4-8fb1-9c98ef963469 58411-241 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION I10 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 319; 363 mg/11g; mg/11g N 20181231 58411-242_6724c9df-66db-4bc4-8fb1-9c98ef963469 58411-242 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION O10 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 319; 363 mg/11g; mg/11g N 20181231 58411-243_6724c9df-66db-4bc4-8fb1-9c98ef963469 58411-243 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 319; 363 mg/11g; mg/11g N 20181231 58411-244_6724c9df-66db-4bc4-8fb1-9c98ef963469 58411-244 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION O30 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 319; 363 mg/11g; mg/11g N 20181231 58411-245_6724c9df-66db-4bc4-8fb1-9c98ef963469 58411-245 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 319; 363 mg/11g; mg/11g N 20181231 58411-246_6724c9df-66db-4bc4-8fb1-9c98ef963469 58411-246 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION O50 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 319; 363 mg/11g; mg/11g N 20181231 58411-247_6724c9df-66db-4bc4-8fb1-9c98ef963469 58411-247 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 319; 363 mg/11g; mg/11g N 20181231 58411-248_6724c9df-66db-4bc4-8fb1-9c98ef963469 58411-248 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION B10 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 319; 363 mg/11g; mg/11g N 20181231 58411-249_6724c9df-66db-4bc4-8fb1-9c98ef963469 58411-249 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 319; 363 mg/11g; mg/11g N 20181231 58411-250_6724c9df-66db-4bc4-8fb1-9c98ef963469 58411-250 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION B30 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 319; 363 mg/11g; mg/11g N 20181231 58411-251_6724c9df-66db-4bc4-8fb1-9c98ef963469 58411-251 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION BF20 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 319; 363 mg/11g; mg/11g N 20181231 58411-252_6724c9df-66db-4bc4-8fb1-9c98ef963469 58411-252 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION WB20 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 319; 363 mg/11g; mg/11g N 20181231 58411-253_e828fac8-fe50-4682-914c-f772e7aef8c7 58411-253 HUMAN OTC DRUG SHISEIDO ULTIMATE SUN PROTECTION OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 8406; 3408; 1590; 18630 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 58411-254_9aecea26-b8be-4322-86d1-db9a16e3080f 58411-254 HUMAN OTC DRUG SHISEIDO ULTIMATE SUN PROTECTION OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 4255; 1725; 805; 9430 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 58411-255_0be5abf4-8a77-4fce-9154-da51be48f16c 58411-255 HUMAN OTC DRUG SHISEIDO BENEFIANCE WRINKLERESIST24 PROTECTIVE HAND REVITALIZER AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1922; 3767; 3844; 1153 mg/75mL; mg/75mL; mg/75mL; mg/75mL N 20181231 58411-256_a6f3116a-0058-4bf5-a388-a1f9166db405 58411-256 HUMAN OTC DRUG SHISEIDO FUTURE LX UNIVERSAL DEFENSE OCTINOXATE, OCTOCRYLENE, OXYBENZONE, and ZINC OXIDE CREAM TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 2717; 1664; 555; 8539 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 58411-257_9c51b27a-cf80-4d57-89ab-bc9fec33c29c 58411-257 HUMAN OTC DRUG SHISEIDO PROTECTIVE LIP CONDITIONER OCTINOXATE STICK TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 196 mg/4g N 20181231 58411-258_fea962cf-d474-465a-a41d-5e391067ea59 58411-258 HUMAN OTC DRUG CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1020; 2499; 2550; 1020 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 58411-259_e559c6ef-3204-4ff8-92bf-aa8d814b7903 58411-259 HUMAN OTC DRUG CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE EMULSION TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3200; 9472; 2560; 1280 mg/125mL; mg/125mL; mg/125mL; mg/125mL N 20181231 58411-260_177dadd5-1293-444c-a7ea-f6d4c05b25c7 58411-260 HUMAN OTC DRUG SHISEIDO ULTIMATE SUN PROTECTION S TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE; ZINC OXIDE 11.61; 24.63 g/100mL; g/100mL N 20181231 58411-261_9cc20e5f-e724-4af2-90a1-242abf54ed9d 58411-261 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN LASTING FOUNDATION Neutral 1 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 911; 754 mg/30mL; mg/30mL N 20181231 58411-262_9cc20e5f-e724-4af2-90a1-242abf54ed9d 58411-262 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN LASTING FOUNDATION Neutral 2 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 911; 754 mg/30mL; mg/30mL N 20181231 58411-263_9cc20e5f-e724-4af2-90a1-242abf54ed9d 58411-263 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN LASTING FOUNDATION Neutral 3 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 911; 754 mg/30mL; mg/30mL N 20181231 58411-264_9cc20e5f-e724-4af2-90a1-242abf54ed9d 58411-264 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN LASTING FOUNDATION Neutral 4 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 911; 754 mg/30mL; mg/30mL N 20181231 58411-265_9cc20e5f-e724-4af2-90a1-242abf54ed9d 58411-265 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN LASTING FOUNDATION Rose 2 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 911; 754 mg/30mL; mg/30mL N 20181231 58411-266_9cc20e5f-e724-4af2-90a1-242abf54ed9d 58411-266 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN LASTING FOUNDATION Rose 3 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 911; 754 mg/30mL; mg/30mL N 20181231 58411-267_9cc20e5f-e724-4af2-90a1-242abf54ed9d 58411-267 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN LASTING FOUNDATION Rose 4 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 911; 754 mg/30mL; mg/30mL N 20181231 58411-268_9cc20e5f-e724-4af2-90a1-242abf54ed9d 58411-268 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN LASTING FOUNDATION Golden 2 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 911; 754 mg/30mL; mg/30mL N 20181231 58411-269_9cc20e5f-e724-4af2-90a1-242abf54ed9d 58411-269 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN LASTING FOUNDATION Golden 3 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 911; 754 mg/30mL; mg/30mL N 20181231 58411-270_9cc20e5f-e724-4af2-90a1-242abf54ed9d 58411-270 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN LASTING FOUNDATION Golden 4 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 911; 754 mg/30mL; mg/30mL N 20181231 58411-271_9cc20e5f-e724-4af2-90a1-242abf54ed9d 58411-271 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN LASTING FOUNDATION Golden 5 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 911; 754 mg/30mL; mg/30mL N 20181231 58411-272_c115b001-5870-4d54-a1f5-32bccf739b1d 58411-272 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION I10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1072; 292 mg/21mL; mg/21mL N 20181231 58411-273_c115b001-5870-4d54-a1f5-32bccf739b1d 58411-273 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION O10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1072; 292 mg/21mL; mg/21mL N 20181231 58411-274_c115b001-5870-4d54-a1f5-32bccf739b1d 58411-274 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1072; 292 mg/21mL; mg/21mL N 20181231 58411-275_c115b001-5870-4d54-a1f5-32bccf739b1d 58411-275 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION O30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1072; 292 mg/21mL; mg/21mL N 20181231 58411-276_c115b001-5870-4d54-a1f5-32bccf739b1d 58411-276 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION B10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1072; 292 mg/21mL; mg/21mL N 20181231 58411-277_c115b001-5870-4d54-a1f5-32bccf739b1d 58411-277 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1072; 292 mg/21mL; mg/21mL N 20181231 58411-278_c115b001-5870-4d54-a1f5-32bccf739b1d 58411-278 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION B30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1072; 292 mg/21mL; mg/21mL N 20181231 58411-279_c115b001-5870-4d54-a1f5-32bccf739b1d 58411-279 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION BF20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1072; 292 mg/21mL; mg/21mL N 20181231 58411-280_c115b001-5870-4d54-a1f5-32bccf739b1d 58411-280 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1072; 292 mg/21mL; mg/21mL N 20181231 58411-281_c115b001-5870-4d54-a1f5-32bccf739b1d 58411-281 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION O50 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1072; 292 mg/21mL; mg/21mL N 20181231 58411-282_c115b001-5870-4d54-a1f5-32bccf739b1d 58411-282 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1072; 292 mg/21mL; mg/21mL N 20181231 58411-283_c115b001-5870-4d54-a1f5-32bccf739b1d 58411-283 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION WB20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1072; 292 mg/21mL; mg/21mL N 20181231 58411-284_2b221754-66ea-451a-b18f-ea9fa4486cca 58411-284 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION IVORY OCTINOXATE STICK TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 306 mg/9g N 20181231 58411-285_2b221754-66ea-451a-b18f-ea9fa4486cca 58411-285 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION OCHER OCTINOXATE STICK TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 306 mg/9g N 20181231 58411-286_2b221754-66ea-451a-b18f-ea9fa4486cca 58411-286 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION MOCHA OCTINOXATE STICK TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 306 mg/9g N 20181231 58411-287_2b221754-66ea-451a-b18f-ea9fa4486cca 58411-287 HUMAN OTC DRUG CLE DE PEAU BEAUTE RADIANT FOUNDATION BEIGE OCTINOXATE STICK TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 306 mg/9g N 20181231 58411-288_b65f1a67-f805-4de0-ae07-71dc22161510 58411-288 HUMAN OTC DRUG CLE DE PEAU BEAUTE UV PROTECTIVE LIP TREATMENT AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE STICK TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 100; 196; 120; 80 mg/4g; mg/4g; mg/4g; mg/4g N 20181231 58411-289_d66744e3-7691-4fca-af4e-05bea4cfd5bd 58411-289 HUMAN OTC DRUG CLE DE PEAU BEAUTE UV PROTECTIVE VERY HIGH PROTECTION FOR BODY OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, and ZINC OXIDE EMULSION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 5678; 2302; 1151; 14808 mg/75mL; mg/75mL; mg/75mL; mg/75mL N 20181231 58411-290_26d6b1a8-1f83-444f-939c-8c603d1650e8 58411-290 HUMAN OTC DRUG CLE DE PEAU BEAUTE UV PROTECTIVE FOR BODY OCTINOXATE, OCTOCRYLENE, OXYBENZONE, and ZINC OXIDE EMULSION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 2277; 3926; 1570; 7537 mg/75mL; mg/75mL; mg/75mL; mg/75mL N 20181231 58411-291_2ecfffcd-f586-4c33-b2f6-33fd508efcaa 58411-291 HUMAN OTC DRUG CLE DE PEAU BEAUTE UV PROTECTIVE OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 3870; 1569; 8577 mg/50mL; mg/50mL; mg/50mL N 20181231 58411-292_8ecd1666-7c73-4a9b-a9fd-c2ad60501364 58411-292 HUMAN OTC DRUG CLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 2449; 993; 1522 mg/30mL; mg/30mL; mg/30mL N 20181231 58411-293_8ecd1666-7c73-4a9b-a9fd-c2ad60501364 58411-293 HUMAN OTC DRUG CLE DE PEAU BEAUTE UV PROTECTIVE TINTED OCHER OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 2449; 993; 1522 mg/30mL; mg/30mL; mg/30mL N 20181231 58411-294_8ecd1666-7c73-4a9b-a9fd-c2ad60501364 58411-294 HUMAN OTC DRUG CLE DE PEAU BEAUTE UV PROTECTIVE TINTED DARK OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 2449; 993; 1522 mg/30mL; mg/30mL; mg/30mL N 20181231 58411-295_7b83886b-dce9-4b2e-9c3d-46dfd98c4a24 58411-295 HUMAN OTC DRUG SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER N AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1283; 3796; 1539; 513 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 58411-296_a5eec4d2-06da-42d6-adb3-b68c08f2f9c0 58411-296 HUMAN OTC DRUG SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHT OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 138; 123 mg/4mL; mg/4mL N 20181231 58411-297_a5eec4d2-06da-42d6-adb3-b68c08f2f9c0 58411-297 HUMAN OTC DRUG SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 138; 123 mg/4mL; mg/4mL N 20181231 58411-298_a5eec4d2-06da-42d6-adb3-b68c08f2f9c0 58411-298 HUMAN OTC DRUG SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM MEDIUM OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 138; 123 mg/4mL; mg/4mL N 20181231 58411-299_919bc189-0139-4899-8018-5130d2057e74 58411-299 HUMAN OTC DRUG SHISEIDO SPORTS BB LIGHT OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1727; 5288 mg/30mL; mg/30mL N 20181231 58411-300_919bc189-0139-4899-8018-5130d2057e74 58411-300 HUMAN OTC DRUG SHISEIDO SPORTS BB MEDIUM OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1727; 5288 mg/30mL; mg/30mL N 20181231 58411-301_919bc189-0139-4899-8018-5130d2057e74 58411-301 HUMAN OTC DRUG SHISEIDO SPORTS BB DARK OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1727; 5288 mg/30mL; mg/30mL N 20181231 58411-302_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-302 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Neutral 1 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-303_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-303 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Neutral 2 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-304_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-304 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Neutral 3 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-305_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-305 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Neutral 4 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-306_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-306 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Neutral 5 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-307_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-307 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Rose 2 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-308_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-308 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Rose 3 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-309_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-309 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Rose 4 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-310_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-310 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Rose 5 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-311_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-311 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Golden 2 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-312_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-312 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Golden 3 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-313_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-313 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Golden 4 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-314_dd9fba42-bc14-4692-a5c5-4b07ad99e8dd 58411-314 HUMAN OTC DRUG SHISEIDO SYNCHRO SKIN GLOW LUMINIZING FLUID FOUNDATION Golden 5 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1655; 676 mg/30mL; mg/30mL N 20181231 58411-315_7062cec8-15c7-4cfc-92bf-914a152dc380 58411-315 HUMAN OTC DRUG CLE DE PEAU BEAUTE THE FOUNDATION I10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1228; 1039 mg/27mL; mg/27mL N 20181231 58411-316_7062cec8-15c7-4cfc-92bf-914a152dc380 58411-316 HUMAN OTC DRUG CLE DE PEAU BEAUTE THE FOUNDATION O10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1228; 1039 mg/27mL; mg/27mL N 20181231 58411-317_7062cec8-15c7-4cfc-92bf-914a152dc380 58411-317 HUMAN OTC DRUG CLE DE PEAU BEAUTE THE FOUNDATION O20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1228; 1039 mg/27mL; mg/27mL N 20181231 58411-318_7062cec8-15c7-4cfc-92bf-914a152dc380 58411-318 HUMAN OTC DRUG CLE DE PEAU BEAUTE THE FOUNDATION O30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1228; 1039 mg/27mL; mg/27mL N 20181231 58411-319_7062cec8-15c7-4cfc-92bf-914a152dc380 58411-319 HUMAN OTC DRUG CLE DE PEAU BEAUTE THE FOUNDATION O40 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1228; 1039 mg/27mL; mg/27mL N 20181231 58411-320_7062cec8-15c7-4cfc-92bf-914a152dc380 58411-320 HUMAN OTC DRUG CLE DE PEAU BEAUTE THE FOUNDATION O50 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1228; 1039 mg/27mL; mg/27mL N 20181231 58411-321_7062cec8-15c7-4cfc-92bf-914a152dc380 58411-321 HUMAN OTC DRUG CLE DE PEAU BEAUTE THE FOUNDATION O60 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1228; 1039 mg/27mL; mg/27mL N 20181231 58411-322_7062cec8-15c7-4cfc-92bf-914a152dc380 58411-322 HUMAN OTC DRUG CLE DE PEAU BEAUTE THE FOUNDATION B10 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1228; 1039 mg/27mL; mg/27mL N 20181231 58411-323_7062cec8-15c7-4cfc-92bf-914a152dc380 58411-323 HUMAN OTC DRUG CLE DE PEAU BEAUTE THE FOUNDATION B20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1228; 1039 mg/27mL; mg/27mL N 20181231 58411-324_7062cec8-15c7-4cfc-92bf-914a152dc380 58411-324 HUMAN OTC DRUG CLE DE PEAU BEAUTE THE FOUNDATION B30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1228; 1039 mg/27mL; mg/27mL N 20181231 58411-325_7062cec8-15c7-4cfc-92bf-914a152dc380 58411-325 HUMAN OTC DRUG CLE DE PEAU BEAUTE THE FOUNDATION BF20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1228; 1039 mg/27mL; mg/27mL N 20181231 58411-326_7062cec8-15c7-4cfc-92bf-914a152dc380 58411-326 HUMAN OTC DRUG CLE DE PEAU BEAUTE THE FOUNDATION WB20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 1228; 1039 mg/27mL; mg/27mL N 20181231 58411-327_6b6710f7-8742-4d87-b183-7d3537ea9aab 58411-327 HUMAN OTC DRUG Shiseido Future Solution LX Total Protective AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE EMULSION TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1136; 5606; 1515; 758 mg/75mL; mg/75mL; mg/75mL; mg/75mL N 20181231 58411-328_81c7a422-9dbc-4f3b-86ef-5ae0f043f727 58411-328 HUMAN OTC DRUG Shiseido Future Solution LX Total Protective E AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1017; 3763; 1526; 763 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 58411-329_6f37e3e9-7970-449a-9fd8-0bed5dd7cbc5 58411-329 HUMAN OTC DRUG SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 1 OCTINOXATE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 2036 mg/30mL N 20181231 58411-330_6f37e3e9-7970-449a-9fd8-0bed5dd7cbc5 58411-330 HUMAN OTC DRUG SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 2 OCTINOXATE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 1832 mg/30mL N 20181231 58411-331_6f37e3e9-7970-449a-9fd8-0bed5dd7cbc5 58411-331 HUMAN OTC DRUG SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 3 OCTINOXATE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 1832 mg/30mL N 20181231 58411-332_6f37e3e9-7970-449a-9fd8-0bed5dd7cbc5 58411-332 HUMAN OTC DRUG SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 4 OCTINOXATE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 1832 mg/30mL N 20181231 58411-333_6f37e3e9-7970-449a-9fd8-0bed5dd7cbc5 58411-333 HUMAN OTC DRUG SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Neutral 1 OCTINOXATE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 1832 mg/30mL N 20181231 58411-334_6f37e3e9-7970-449a-9fd8-0bed5dd7cbc5 58411-334 HUMAN OTC DRUG SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Neutral 2 OCTINOXATE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 1832 mg/30mL N 20181231 58411-335_6f37e3e9-7970-449a-9fd8-0bed5dd7cbc5 58411-335 HUMAN OTC DRUG SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Neutral 3 OCTINOXATE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 1832 mg/30mL N 20181231 58411-336_6f37e3e9-7970-449a-9fd8-0bed5dd7cbc5 58411-336 HUMAN OTC DRUG SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Neutral 4 OCTINOXATE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 1832 mg/30mL N 20181231 58411-337_6f37e3e9-7970-449a-9fd8-0bed5dd7cbc5 58411-337 HUMAN OTC DRUG SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Rose 2 OCTINOXATE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 1832 mg/30mL N 20181231 58411-338_6f37e3e9-7970-449a-9fd8-0bed5dd7cbc5 58411-338 HUMAN OTC DRUG SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Rose 3 OCTINOXATE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 1832 mg/30mL N 20181231 58411-339_6f37e3e9-7970-449a-9fd8-0bed5dd7cbc5 58411-339 HUMAN OTC DRUG SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Rose 4 OCTINOXATE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE 1832 mg/30mL N 20181231 58411-340_cd4b9d25-f78f-4c35-b6c5-8ce7f3c0f836 58411-340 HUMAN OTC DRUG SHISEIDO IBUKI MULTI SALICYLIC ACID GEL TOPICAL 20150201 OTC MONOGRAPH FINAL part333D SHISEIDO AMERICAS CORPORATION SALICYLIC ACID 154 mg/30mL N 20181231 58411-341_8d4da6a2-efe1-411e-aa5f-8cdd51f5268c 58411-341 HUMAN OTC DRUG SHISEIDO WASO COLOR-SMART DAY MOISTURIZER oil-free OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 4177; 2766 mg/50mL; mg/50mL N 20181231 58411-342_d6dc30ed-d6b6-4f07-9f3f-03c1df031695 58411-342 HUMAN OTC DRUG SHISEIDO WASO COLOR-SMART DAY MOISTURIZER OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; TITANIUM DIOXIDE 3955; 2245 mg/50mL; mg/50mL N 20181231 58411-343_655a9c8a-b481-4e94-9545-bdedfbd937b0 58411-343 HUMAN OTC DRUG SHISEIDO BENEFIANCE WRINKLERESIST24 DAY AVOBENZONE, OCTINOXATE, and OCTOCRYLENE EMULSION TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1946; 5761; 1557 mg/77.85g; mg/77.85g; mg/77.85g N 20181231 58411-344_7283bc6d-7e4e-4f1b-b172-8a8147387569 58411-344 HUMAN OTC DRUG SHISEIDO BENEFIANCE WRINKLERESIST24 DAY AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1289; 3815; 1031 mg/51.55g; mg/51.55g; mg/51.55g N 20181231 58411-345_2c55ba5a-cef6-4165-943b-6b5a9ebf5efc 58411-345 HUMAN OTC DRUG SHISEIDO SUN PROTECTION EYE OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 479; 495; 1749 mg/16.5g; mg/16.5g; mg/16.5g N 20181231 58411-346_b5f32495-c709-401c-8d7e-6088c952efd2 58411-346 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT Oil-FREE UV PROTECTOR OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICA INC. OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1557; 953; 3971 mg/31.77g; mg/31.77g; mg/31.77g N 20181231 58411-347_68d137b8-71a1-4938-9a08-485a56f850a1 58411-347 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT UV PROTECTION OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1583; 1638; 5788 mg/54.6g; mg/54.6g; mg/54.6g N 20181231 58411-348_0d073d45-c2bb-470b-a90d-1f11573eca0f 58411-348 HUMAN OTC DRUG SHISEIDO EXTRA SMOOTH SUN PROTECTION N OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 2766; 1694; 7056 mg/56.45g; mg/56.45g; mg/56.45g N 20181231 58411-349_b593181d-0c1b-4a13-a7c6-f69f8f9305f5 58411-349 HUMAN OTC DRUG SHISEIDO EXTRA SMOOTH SUN PROTECTION N OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 5424; 3321; 13.84 mg/110.7g; mg/110.7g; g/110.7g N 20181231 58411-350_15efee8e-065a-4a77-957d-a96e5055bc5b 58411-350 HUMAN OTC DRUG SHISEIDO URBAN ENVIRONMENT Oil-FREE UV PROTECTOR Octinoxate, Octocrylene, and Zinc Oxide EMULSION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 2.27; .92; 2.64 g/30.66g; g/30.66g; g/30.66g N 20181231 58411-351_08757d37-8d0d-4fa9-8980-92a05790c039 58411-351 HUMAN OTC DRUG SHISEIDO BENEFIANCE NUTRIPERFECT DAY AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1286; 3807; 1029 mg/51.45g; mg/51.45g; mg/51.45g N 20181231 58411-352_87e560e5-9195-4274-aebb-b4cd7e73032b 58411-352 HUMAN OTC DRUG REVIVE MOISTURIZING RENEWAL AVOBENZONE and OCTINOXATE CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 REVIVE SKINCARE AVOBENZONE; OCTINOXATE 1500; 3746 mg/50g; mg/50g N 20181231 58411-353_8eb94fc3-e12a-4b74-8fa8-8a45142f459c 58411-353 HUMAN OTC DRUG CLE DE PEAU BEAUTE CONCEALER IVORY TITANIUM DIOXIDE STICK TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 80 mg/5g N 20181231 58411-354_8eb94fc3-e12a-4b74-8fa8-8a45142f459c 58411-354 HUMAN OTC DRUG CLE DE PEAU BEAUTE CONCEALER OCHER TITANIUM DIOXIDE STICK TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 80 mg/5g N 20181231 58411-355_8eb94fc3-e12a-4b74-8fa8-8a45142f459c 58411-355 HUMAN OTC DRUG CLE DE PEAU BEAUTE CONCEALER BEIGE TITANIUM DIOXIDE STICK TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 80 mg/5g N 20181231 58411-356_8eb94fc3-e12a-4b74-8fa8-8a45142f459c 58411-356 HUMAN OTC DRUG CLE DE PEAU BEAUTE CONCEALER HONEY TITANIUM DIOXIDE STICK TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 80 mg/5g N 20181231 58411-357_8eb94fc3-e12a-4b74-8fa8-8a45142f459c 58411-357 HUMAN OTC DRUG CLE DE PEAU BEAUTE CONCEALER ALMOND TITANIUM DIOXIDE STICK TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 80 mg/5g N 20181231 58411-358_8eb94fc3-e12a-4b74-8fa8-8a45142f459c 58411-358 HUMAN OTC DRUG CLE DE PEAU BEAUTE CONCEALER MOCHA TITANIUM DIOXIDE STICK TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION TITANIUM DIOXIDE 80 mg/5g N 20181231 58411-359_e8bedd2d-2b8a-40f8-94a0-b2a36c2dec3c 58411-359 HUMAN OTC DRUG SHISEIDO ULTIMATE SUN PROTECTION AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1288; 2524; 2575; 1545 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20191231 58411-360_11835cb8-2f4e-4368-aca1-46a5968a6c40 58411-360 HUMAN OTC DRUG SHISEIDO UV LIP COLOR SPLASH NAIROBI ORANGE AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE GEL TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 238; 466; 285; 190 mg/10mL; mg/10mL; mg/10mL; mg/10mL N 20191231 58411-361_11835cb8-2f4e-4368-aca1-46a5968a6c40 58411-361 HUMAN OTC DRUG SHISEIDO UV LIP COLOR SPLASH MIAMI PINK AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE GEL TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 238; 466; 285; 190 mg/10mL; mg/10mL; mg/10mL; mg/10mL N 20191231 58411-362_11835cb8-2f4e-4368-aca1-46a5968a6c40 58411-362 HUMAN OTC DRUG SHISEIDO UV LIP COLOR SPLASH ULURU RED AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE GEL TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 238; 466; 285; 190 mg/10mL; mg/10mL; mg/10mL; mg/10mL N 20191231 58411-363_11835cb8-2f4e-4368-aca1-46a5968a6c40 58411-363 HUMAN OTC DRUG SHISEIDO UV LIP COLOR SPLASH TAHITI BLUE AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE GEL TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 238; 466; 285; 190 mg/10mL; mg/10mL; mg/10mL; mg/10mL N 20191231 58411-364_16c8e0bf-47d7-4282-b9d3-a195c39e8b1e 58411-364 HUMAN OTC DRUG SHISEIDO ESSENTIAL ENERGY DAY AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1020; 2550; 3773; 1530; 765 mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 58411-365_89c6b92b-95f5-48a4-9ef7-34c8cf120573 58411-365 HUMAN OTC DRUG SHISEIDO CLEAR stick UV PROTECTOR AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20180201 OTC MONOGRAPH FINAL part352 SHISEIDO AMERICAS CORPORATION AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 375; 1500; 735; 750; 750; 450 mg/15g; mg/15g; mg/15g; mg/15g; mg/15g; mg/15g N 20181231 58411-366_e0d655c6-b99b-4d19-b9df-f7363859a948 58411-366 HUMAN OTC DRUG Laura Mercier Flawless Skin Repair Oil-Free Day Broad Spectrum SPF 15 Avobenzone, Octinoxate, and Oxybenzone LOTION TOPICAL 20160413 OTC MONOGRAPH NOT FINAL part352 Laura Mercier AVOBENZONE; OCTINOXATE; OXYBENZONE 400; 1750; 250 mg/50mL; mg/50mL; mg/50mL N 20191231 58411-367_13c38199-6b94-4357-9b1b-f448269811ff 58411-367 HUMAN OTC DRUG REVIVE INTENSITE CREME LUSTRE DAY Firming Moisture Cream Broad Spectrum SPF 30 Sunscreen Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20161201 OTC MONOGRAPH FINAL part352 Revive Skincare AVOBENZONE; OCTISALATE; OCTOCRYLENE 1500; 2500; 4000 mg/50g; mg/50g; mg/50g N 20191231 58411-368_48ac82cf-0be5-41e4-8d93-4353c98e1a17 58411-368 HUMAN OTC DRUG Laura Mercier Foundation Primer Protect Broad Spectrum SPF 30 Sunscreen Avobenzone, Octinoxate, Octocrylene, and Oxybenzone CREAM TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 1500; 3650; 1500; 1000 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20191231 58411-369_05dc89a7-c7b7-427e-96df-ba36e5f0e40f 58411-369 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Illuminating Broad Spectrum SPF 20 Sunscreen 5N1 Bronze Radiance AVOBENZONE and OCTINOXATE CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-370_05dc89a7-c7b7-427e-96df-ba36e5f0e40f 58411-370 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Illuminating Broad Spectrum SPF 20 Sunscreen 4N1 Golden Radiance AVOBENZONE and OCTINOXATE CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-371_05dc89a7-c7b7-427e-96df-ba36e5f0e40f 58411-371 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Illuminating Broad Spectrum SPF 20 Sunscreen 3N1 Warm Radiance AVOBENZONE and OCTINOXATE CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-372_05dc89a7-c7b7-427e-96df-ba36e5f0e40f 58411-372 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Illuminating Broad Spectrum SPF 20 Sunscreen 2N1 Natural Radiance AVOBENZONE and OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-373_05dc89a7-c7b7-427e-96df-ba36e5f0e40f 58411-373 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Illuminating Broad Spectrum SPF 20 Sunscreen 1N1 Bare Radiance AVOBENZONE and OCTINOXATE CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-374_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-374 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 1C1 Cameo Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-375_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-375 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 1W1 Porcelain Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-376_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-376 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 2C1 Blush Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-377_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-377 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 2W1 Bisque Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-378_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-378 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 2W2 Nude Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-381_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-381 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 2W3 Natural Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-382_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-382 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum 20 Sunscreen 3C1 Fawn Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-383_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-383 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 3W1 Ochre Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-384_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-384 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 3W2 Sand Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-386_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-386 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 4C1 Almond Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-387_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-387 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 4W1 Tawny Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-388_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-388 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 5C1 Caramel Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-389_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-389 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 5W1 Tan Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-390_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-390 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 6C1 Walnut Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-391_c8062aa5-9aeb-4d1a-9a56-77c15951c60a 58411-391 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Sunscreen 6W1 Mocha Octinoxate and Octisalate CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20191231 58411-392_a0fc786f-af9d-440f-b913-f32596a0485c 58411-392 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 1C1 Cameo AVOBENZONE and OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-393_71541dd9-e086-4c3b-a467-978fe4c13a0f 58411-393 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 1W1 Porcelain MERADIMATE and OCTINOXATE CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL N 20191231 58411-394_a0fc786f-af9d-440f-b913-f32596a0485c 58411-394 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 2C1 Blush AVOBENZONE and OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-395_a0fc786f-af9d-440f-b913-f32596a0485c 58411-395 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 2W1 Bisque AVOBENZONE and OCTINOXATE CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-396_71541dd9-e086-4c3b-a467-978fe4c13a0f 58411-396 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 2W2 Nude MERADIMATE and OCTINOXATE CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL N 20191231 58411-399_a0fc786f-af9d-440f-b913-f32596a0485c 58411-399 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 2W3 Natural AVOBENZONE and OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-400_71541dd9-e086-4c3b-a467-978fe4c13a0f 58411-400 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 3C1 Fawn MERADIMATE and OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL N 20191231 58411-401_a0fc786f-af9d-440f-b913-f32596a0485c 58411-401 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 3W1 Ochre AVOBENZONE and OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-402_71541dd9-e086-4c3b-a467-978fe4c13a0f 58411-402 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 3W2 Sand MERADIMATE and OCTINOXATE CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL N 20191231 58411-404_71541dd9-e086-4c3b-a467-978fe4c13a0f 58411-404 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 4C1 Almond MERADIMATE and OCTINOXATE CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL N 20191231 58411-405_a0fc786f-af9d-440f-b913-f32596a0485c 58411-405 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 4W1 Tawny AVOBENZONE and OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-406_a0fc786f-af9d-440f-b913-f32596a0485c 58411-406 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 5C1 Caramel AVOBENZONE and OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-407_71541dd9-e086-4c3b-a467-978fe4c13a0f 58411-407 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 5W1 Tan MERADIMATE and OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL N 20191231 58411-408_71541dd9-e086-4c3b-a467-978fe4c13a0f 58411-408 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 6C1 Walnut MERADIMATE and OCTINOXATE CREAM TOPICAL 20170105 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL N 20191231 58411-409_a0fc786f-af9d-440f-b913-f32596a0485c 58411-409 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 6W1 Mocha AVOBENZONE and OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 1000; 3750 mg/50mL; mg/50mL N 20191231 58411-410_8c704284-8ab4-43bc-9ab0-724ae37a1afb 58411-410 HUMAN OTC DRUG Laura Mercier Flawless Skin Moisture Creme Broad Spectrum SPF 15 Sunscreen for Normal Combination Skin Avobenzone and Octinoxate CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 20; 75 mg/g; mg/g N 20191231 58411-411_993d445d-6814-4caf-9be2-ad0d0bc46e82 58411-411 HUMAN OTC DRUG Laura Mercier Flawless Skin Mega Moisture Creme Broad Spectrum SPF 15 Sunscreen For Normal/Dry Skin Avobenzone and OCTINOXATE CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE 20; 75 mg/g; mg/g N 20191231 58411-412_b74de93a-4cf8-4a25-96b1-b75c011084ec 58411-412 HUMAN OTC DRUG Laura Mercier Flawless Skin Repair Day Creme Broad Spectrum SPF 15 Sunscreen Avobenzone, Octinoxate, and Oxybenzone CREAM TOPICAL 20161025 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics AVOBENZONE; OCTINOXATE; OXYBENZONE 8; 35; 5 mg/g; mg/g; mg/g N 20191231 58411-413_04bae1af-4b13-43bc-8ee7-a4afeec57778 58411-413 HUMAN OTC DRUG Laura Mercier Flawless Skin Daily Face Shield SPF 40 Sunscreen Octinoxate and Titanium Dioxide CREAM TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part352 Laura Mercier Cosmetics OCTINOXATE; TITANIUM DIOXIDE 75; 50 mg/mL; mg/mL N 20191231 58411-414_b9898b4d-8b23-4fb5-ad4a-a6bfd337516b 58411-414 HUMAN OTC DRUG ReVive Acne Reparatif Acne Treatment Gel SALICYLIC ACID CREAM TOPICAL 20080901 OTC MONOGRAPH FINAL part333D RéVive Skincare SALICYLIC ACID 5 mg/mL N 20191231 58411-415_96f336ad-cb08-4b6e-b7f7-513626601063 58411-415 HUMAN OTC DRUG ReVive Fermitif Hand Renewal Broad Spectrum SPF 15 Sunscreen AVOBENZONE, OCTINOXATE, and OCTISALATE CREAM TOPICAL 20151030 OTC MONOGRAPH NOT FINAL part352 RéVive Skincare AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/g; mg/g; mg/g N 20191231 58411-416_0ee8ad94-7dc1-4e40-bcb2-b4c6a8ae6d4e 58411-416 HUMAN OTC DRUG ReVive Fermitif Neck Renewal Broad Spectrum SPF 15 Sunscreen AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part352 RéVive Skincare AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 20; 60; 27; 20 mg/g; mg/g; mg/g; mg/g N 20191231 58411-417_3f35a780-7797-4d60-b46e-f9f5ef998f33 58411-417 HUMAN OTC DRUG ReVive Perfectif Even Skin Tone Dark Spot Corrector Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 RéVive Skincare AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 10; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20191231 58411-418_eb57bc5d-7c2e-45a5-8d4c-0c2e92668ca3 58411-418 HUMAN OTC DRUG ReVive Sensitif Oil Free Broad Spectrum SPF 15 Sunscreen Avobenzone and Octinoxate CREAM TOPICAL 20141110 OTC MONOGRAPH NOT FINAL part352 RéVive Skincare AVOBENZONE; OCTINOXATE 30; 75 mg/mL; mg/mL N 20191231 58411-419_5d5602f0-5896-48c1-8f49-d43e65d2c2d9 58411-419 HUMAN OTC DRUG ReVive Sensitif Renewal Daily Cellular Protection Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 RéVive Skincare AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 10; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20191231 58411-420_6fa17b14-e975-45a0-8e72-a1116134f7a3 58411-420 HUMAN OTC DRUG ReVive Soleil Superieur Broad Spectrum SPF 50 Sunscreen PA Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 RéVive Skincare AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 26 mg/g; mg/g; mg/g; mg/g N 20191231 58414-0001_b76c8e17-b5ba-4c64-93c1-f09815a95547 58414-0001 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 20 Bisque TITANIUM DIOXIDE LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company, Inc. TITANIUM DIOXIDE 78 mg/mL E 20171231 58414-0002_b76c8e17-b5ba-4c64-93c1-f09815a95547 58414-0002 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 20 Blush Beige TITANIUM DIOXIDE LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company, Inc. TITANIUM DIOXIDE 78 mg/mL E 20171231 58414-0003_b76c8e17-b5ba-4c64-93c1-f09815a95547 58414-0003 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 20 True Beige TITANIUM DIOXIDE LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company, Inc. TITANIUM DIOXIDE 78 mg/mL E 20171231 58414-0004_b76c8e17-b5ba-4c64-93c1-f09815a95547 58414-0004 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 20 Neutral Beige TITANIUM DIOXIDE LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company, Inc. TITANIUM DIOXIDE 78 mg/mL E 20171231 58414-0005_b76c8e17-b5ba-4c64-93c1-f09815a95547 58414-0005 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 20 Warm Beige TITANIUM DIOXIDE LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company, Inc. TITANIUM DIOXIDE 78 mg/mL E 20171231 58414-0006_b76c8e17-b5ba-4c64-93c1-f09815a95547 58414-0006 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 20 Honey Sand TITANIUM DIOXIDE LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company, Inc. TITANIUM DIOXIDE 78 mg/mL E 20171231 58414-0007_b76c8e17-b5ba-4c64-93c1-f09815a95547 58414-0007 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 20 Desert Sand TITANIUM DIOXIDE LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company, Inc. TITANIUM DIOXIDE 78 mg/mL E 20171231 58414-0008_b76c8e17-b5ba-4c64-93c1-f09815a95547 58414-0008 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 20 Classic Beige TITANIUM DIOXIDE LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company, Inc. TITANIUM DIOXIDE 78 mg/mL E 20171231 58414-0009_b76c8e17-b5ba-4c64-93c1-f09815a95547 58414-0009 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 20 Golden Beige TITANIUM DIOXIDE LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company, Inc. TITANIUM DIOXIDE 78 mg/mL E 20171231 58414-0010_b76c8e17-b5ba-4c64-93c1-f09815a95547 58414-0010 HUMAN OTC DRUG Exuviance CoverBlend Skin Caring Foundation SPF 20 Toasted Almond TITANIUM DIOXIDE LIQUID TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company, Inc. TITANIUM DIOXIDE 78 mg/mL E 20171231 58414-0011_29fa48f3-202f-40ec-810d-7b5c8aee22bf 58414-0011 HUMAN OTC DRUG NeoStrata Enlighten Skin Brightener SPF 25 OCTINOXATE, OCTISALATE, and AVOBENZONE CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 75; 50; 30 mg/g; mg/g; mg/g E 20171231 58414-2021_b6c59652-fe56-4647-a9e7-a68d624249f2 58414-2021 HUMAN OTC DRUG Exuviance Daily Acne Peel Exfoliating Anti-Blemish Pads SALICYLIC ACID LIQUID TOPICAL 20150301 20180616 OTC MONOGRAPH FINAL part333D NeoStrata Company Inc. SALICYLIC ACID 20 mg/mL E 20171231 58414-2040_67969e64-5ce5-4cc7-aed4-21ddb3cc127f 58414-2040 HUMAN OTC DRUG Exuviance Age Reverse Day Repair SPF 30 AVOBENZONE, OCTINOXATE, and OCTISALATE CREAM TOPICAL 20130712 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/g; mg/g; mg/g E 20171231 58414-2046_41083c54-b919-4cf9-9068-618644646e40 58414-2046 HUMAN OTC DRUG Exuviance Essential Daily Defense SPF 30 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 40 mg/g; mg/g E 20171231 58414-2047_9bec5055-0984-4fab-b4f4-128f8e03ba97 58414-2047 HUMAN OTC DRUG Exuviance Sheer Refining Fluid SPF 35 OCTINOXATE, OCTISALATE, and AVOBENZONE LOTION TOPICAL 20130702 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 75; 50; 30 mg/mL; mg/mL; mg/mL E 20171231 58414-2048_4f3c4518-7bac-4fbc-a856-4daa767b4b61 58414-2048 HUMAN OTC DRUG Exuviance Multi Protective Day SPF 20 Octinoxate and Titanium Dioxide CREAM TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 40 mg/g; mg/g E 20171231 58414-2099_35c2968c-fdf9-46a0-bc7b-7eb9dda0ade0 58414-2099 HUMAN OTC DRUG Exuviance Optilight All-Over Dark Spot Minimizer SPF 25 OCTINOXATE, OCTISALATE, and AVOBENZONE CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 75; 50; 30 mg/g; mg/g; mg/g E 20171231 58414-2100_a94a7c53-0f30-4556-880f-1c47374582f9 58414-2100 HUMAN OTC DRUG Exuviance Sheer Daily Protector SPF 50 TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 70; 60 mg/mL; mg/mL E 20171231 58414-3042_8b17e3fa-e4f6-4329-93cf-dbe9f2e748c5 58414-3042 HUMAN OTC DRUG NeoStrata Skin Active Matrix Support SPF 30 AVOBENZONE, OCTINOXATE, and OCTISALATE CREAM TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/g; mg/g; mg/g E 20171231 58414-3046_5afbdaad-39a8-47dd-9cd1-ec7953e5e891 58414-3046 HUMAN OTC DRUG NeoStrata Ultra Daytime Smoothing SPF 20 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 40 mg/g; mg/g E 20171231 58414-3047_7a221941-74b8-4946-a1e6-c75aadf7c301 58414-3047 HUMAN OTC DRUG NeoStrata Sheer Hydration SPF 35 OCTINOXATE, OCTISALATE, and AVOBENZONE LOTION TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 75; 50; 30 mg/mL; mg/mL; ug/mL E 20171231 58414-3048_8cca94a8-ec74-4d7a-9106-ae3b77c89341 58414-3048 HUMAN OTC DRUG NeoStrata Daytime Protection SPF 23 Octinoxate and Titanium Dioxide CREAM TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. OCTINOXATE; TITANIUM DIOXIDE 60; 40 mg/g; mg/g E 20171231 58414-3100_3f72d206-fd5b-4ce4-b8b4-d32deddca086 58414-3100 HUMAN OTC DRUG NeoStrata Sheer Physical Protection SPF 50 TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20150201 20181229 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 70; 60 mg/mL; mg/mL N 20181231 58414-3501_bd1a817b-1eb7-4d2e-b7d9-f374cf85e387 58414-3501 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Bisque TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 159.7; 20.9 mg/g; mg/g E 20171231 58414-3502_e44a5e2f-b3fe-46f0-8314-60cf6dc17a29 58414-3502 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Classic Beige TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 152.9; 20.9 mg/g; mg/g E 20171231 58414-3503_7b9626ca-c8dc-43d0-bea3-f0be85ff1bf0 58414-3503 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Warm Beige TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 153.4; 20.9 mg/g; mg/g E 20171231 58414-3504_d1119860-0f25-45d2-84e7-5802098bbb22 58414-3504 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Neutral Sand TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 152.9; 20.9 mg/g; mg/g E 20171231 58414-3505_fc59dc5a-3bd5-441a-8e08-c5eedd85e374 58414-3505 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 True Beige TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 148; 20.9 mg/g; mg/g E 20171231 58414-3506_ba4bffed-a5bc-4066-ad28-f3c15b744ff5 58414-3506 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Golden Beige TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 143; 20.9 mg/g; mg/g E 20171231 58414-3507_818d717d-8453-4cc2-963a-9cc8d2a7bdb8 58414-3507 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Toasted Almond TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 137.1; 20.9 mg/g; mg/g E 20171231 58414-3508_850113ac-7587-480b-9f6f-d443ca4180af 58414-3508 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Honey Sand TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 143.6; 20.9 mg/g; mg/g E 20171231 58414-3509_50caa416-6462-4a05-93fe-33429741a203 58414-3509 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Desert Sand TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 131.1; 20.9 mg/g; mg/g E 20171231 58414-3510_116468ef-9aa3-4ecc-bf74-614f09e9a323 58414-3510 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Terracotta Sand TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 120.9; 20.9 mg/g; mg/g E 20171231 58414-3511_ccf1efaa-2254-496b-90ce-fc0c7e678f95 58414-3511 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Caramel TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 103; 20.9 mg/g; mg/g E 20171231 58414-3512_e04ebaac-9378-404e-8594-fbdabbb547a0 58414-3512 HUMAN OTC DRUG Exuviance CoverBlend Concealing Treatment Makeup SPF 30 Mocha TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NeoStrata Company Inc. TITANIUM DIOXIDE; ZINC OXIDE 85.8; 20.9 mg/g; mg/g E 20171231 58414-8321_e1238489-0b98-4cce-8f74-38bbc44bc19f 58414-8321 HUMAN OTC DRUG NeoStrata Antibacterial Facial Cleanser TRICLOSAN LIQUID TOPICAL 20110425 20181112 OTC MONOGRAPH NOT FINAL part333E NeoStrata Company Inc TRICLOSAN 3 mg/mL E 20171231 58414-8712_aeb13914-ca1d-4c5e-b322-4e6d3e2b03cf 58414-8712 HUMAN OTC DRUG Blemish Treatment Salicylic Acid GEL TOPICAL 20101030 OTC MONOGRAPH FINAL part333D NeoStrata Company Inc SALICYLIC ACID .02 g/g E 20171231 58414-8748_83a570bb-28a5-4049-8930-643c865ad9f1 58414-8748 HUMAN OTC DRUG Exuviance Moisturizing Antibacterial Facial Cleanser TRICLOSAN LIQUID TOPICAL 20110425 20181112 OTC MONOGRAPH NOT FINAL part333E NeoStrata Company Inc TRICLOSAN 3 mg/mL E 20171231 58414-8808_2d19bb72-550d-429e-821f-10ebaa3ba506 58414-8808 HUMAN OTC DRUG NeoStrata HQ Skin Lightening HYDROQUINONE GEL TOPICAL 20110222 OTC MONOGRAPH NOT FINAL part358A NeoStrata Company Inc HYDROQUINONE .02 g/g E 20171231 58414-8960_5a446352-9cd4-4642-b766-a048a1ba7761 58414-8960 HUMAN OTC DRUG Psorent COAL TAR SOLUTION TOPICAL 20130717 20190129 OTC MONOGRAPH FINAL part358H NeoStrata Company Inc. COAL TAR 23 mg/mL E 20171231 58416-001_205902fd-6394-653b-e054-00144ff8d46c 58416-001 HUMAN OTC DRUG Nelly de Vuyst SPF 30 Broad Spectrum Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20141023 OTC MONOGRAPH NOT FINAL part352 7774672 Canada Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; .1; 50; 20; 25 mg/g; g/g; mg/g; mg/g; mg/g N 20181231 58418-223_092bafd9-8c28-56df-e054-00144ff88e88 58418-223 HUMAN OTC DRUG Skin Crave spf30 sunscreen spf30 sunscreen lotion (non-broad spectrum) LOTION TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Tropical Enterprises International, Inc. OCTISALATE; OXYBENZONE; OCTOCRYLENE; OCTINOXATE 4; 5.5; 7; 6.5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58418-224_097c571a-e7be-0e01-e054-00144ff8d46c 58418-224 HUMAN OTC DRUG Skin Crave Broad Spectrum spf30 spf30 Broad Spectrum Sunscreen lotion LOTION TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Tropical Enterprises International Inc AVOBENZONE; OCTOCRYLENE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 10; 10; 5; 6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58418-295_484dcd16-27c3-1113-e054-00144ff8d46c 58418-295 HUMAN OTC DRUG Skin Crave spf15 lip balm spf15 lip balm (chemical) LIPSTICK TOPICAL 20120801 OTC MONOGRAPH FINAL part352 Tropical Enterprises International, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE; OCTINOXATE 1.5; 5; 2; 6.5 mg/15mL; mg/15mL; g/15mL; mg/15mL N 20181231 58418-424_484f9c2f-efe8-2422-e054-00144ff88e88 58418-424 HUMAN OTC DRUG Skin Crave All Natural SPF30 All Natural spf30 sunscreen lotion LOTION TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 Tropical Enterprises International, Inc TITANIUM DIOXIDE; ZINC OXIDE 10; 5 mg/mL; mg/mL N 20181231 58418-786_48440f5b-7f26-224a-e054-00144ff8d46c 58418-786 HUMAN OTC DRUG Skin Crave non-alcohol Hand Sanitizer Antibacterial Non-Alcohol Hand Sanitizer SPRAY TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333A Tropical Enterprises International, Inc. BENZALKONIUM CHLORIDE 13 mg/mL N 20181231 58420-001_6d5083ee-2a43-4388-afb0-ae7bc37ef146 58420-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc OXYGEN 992 mL/L E 20171231 58420-002_5d1f77ff-b355-4463-9f8b-a75bdb6b4d93 58420-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc NITROGEN 992 mL/L E 20171231 58420-003_275e87da-a1ba-4e2f-8dd7-0cf598db21ee 58420-003 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc NITROUS OXIDE 992 mL/L E 20171231 58420-004_17eaf086-da43-45a9-96f7-4963599d8041 58420-004 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc HELIUM 992 mL/L E 20171231 58420-005_eb13cea1-3db6-4606-80ee-bbbea7f570dd 58420-005 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19580101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc AIR 1000 mL/L E 20171231 58420-006_831a4542-6a79-419b-b286-2d8362e52d46 58420-006 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc CARBON DIOXIDE 992 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 58420-007_3d051449-4685-42c2-b8d1-fa928c82d55c 58420-007 HUMAN PRESCRIPTION DRUG Helium Oxygen Mixture Helium Oxygen Mixture GAS RESPIRATORY (INHALATION) 19980101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc HELIUM; OXYGEN 800; 200 mL/L; mL/L E 20171231 58420-009_6ebe9ecb-fa0c-44ef-847d-11365dc23c26 58420-009 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture Carbon Dioxide Oxygen Mixture GAS RESPIRATORY (INHALATION) 19980101 UNAPPROVED MEDICAL GAS Airgas Intermountain Inc CARBON DIOXIDE; OXYGEN 300; 700 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 58443-0015_a75d6a30-96e6-4c95-8440-4136733bccc0 58443-0015 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20120420 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 10; 27.5; 10 mg/mL; mg/mL; mg/mL N 20181231 58443-0016_c76f75fa-464b-4c95-a507-16fe3ef41f84 58443-0016 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120420 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.9; 49.9; 27.5; 4.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0017_00c73d53-cc3a-41a2-9359-fea160d61fc0 58443-0017 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120619 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75.1; 50.1; 27.5; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0018_f3860591-f938-4068-831d-5d8511bddf60 58443-0018 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120619 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75.1; 50.1; 27.5; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0019_4eaa73c1-bb87-48c5-9a30-c6bf61099549 58443-0019 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120619 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75.1; 50.1; 27.5; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0020_0047124a-c2f2-402a-9cd6-885d8033fd66 58443-0020 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120321 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.7; 102.3; 51.2; 28.1; 40.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0021_276758c8-c469-441e-90d4-7ed37a5e0232 58443-0021 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 4 Avobenzone, Octocrylene, and Oxybenzone OIL TOPICAL 20121113 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 4.46; 8.92; 4.46 mg/mL; mg/mL; mg/mL N 20181231 58443-0022_4fe46cdf-e909-4331-9516-b926d5d8d3d1 58443-0022 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 4 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20120409 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 4.9; 9.8; 4.9 mg/mL; mg/mL; mg/mL N 20181231 58443-0023_cf49327e-c9e9-49ff-ab6f-4850442c96b6 58443-0023 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20120416 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 9.7; 26.8; 9.7 mg/mL; mg/mL; mg/mL N 20181231 58443-0024_c47045b1-330f-4919-b700-5fdc776ec754 58443-0024 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111213 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.7; 49.4; 27.1; 4.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0025_5d7d39df-f05e-4b3e-8e16-0b4b12c72d5c 58443-0025 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111229 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.6; 73.4; 48.9; 26.9; 19.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0026_ebdacfd1-cb2e-4be1-bfbb-e9a478aebeaf 58443-0026 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20120702 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 9.5; 26.2; 9.5 mg/mL; mg/mL; mg/mL N 20181231 58443-0027_f80ec605-7ff0-4137-8b78-8bab19ddbe8f 58443-0027 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120328 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.7; 49; 26.9; 4.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0028_08b0ea7b-778a-4ab4-93ba-3bee9b5a200d 58443-0028 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120326 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.5; 73.1; 48.8; 26.8; 19.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0029_a3846dc3-e122-4768-90a6-a7ddd4f82449 58443-0029 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20131118 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 4.9; 19.4; 14.6 mg/mL; mg/mL; mg/mL N 20181231 58443-0030_ebbc35c6-19a3-48ba-9048-847c88814f98 58443-0030 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20131025 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 19.5; 48.7; 26.8 mg/mL; mg/mL; mg/mL N 20181231 58443-0031_6b801bd1-c0c5-4ebb-bc93-59ace5990de2 58443-0031 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130729 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.8; 74; 49.4; 27.1; 19.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0032_84234bb2-781f-41cf-a5c6-a3c9cb652b17 58443-0032 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 45 Avobenzone,Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20130125 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 28.9; 144.3; 48.1; 26.5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0033_258384b5-d3da-4f2e-a551-ed5a14ca0817 58443-0033 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 45 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130204 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.6; 102; 51; 28.1; 20.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0034_fe70a6a5-3401-42f7-aff3-2b9bc1a02a8c 58443-0034 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 4 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20131019 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 9.8; 8.3; 4.9 mg/mL; mg/mL; mg/mL N 20181231 58443-0035_d328b72b-e3d4-408c-bdd9-f40fedd6289c 58443-0035 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 8 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131014 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 9.9; 29.7; 8.4; 9.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0037_a3710a41-b2d4-4aa7-ba45-efa292b06a88 58443-0037 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131015 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.7; 49.3; 18.2; 4.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0038_5ed982df-70b6-4556-a25d-ff5cc128e63c 58443-0038 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131022 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.6; 49; 18.13; 4.9 mg/mL; mg/mL; 1/mL; mg/mL N 20181231 58443-0040_278de50d-919e-4663-98e9-4d05b29701a1 58443-0040 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.5; 76.1; 50.8; 27.5; 20.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0041_8869c0eb-5d9b-455e-8288-c5ff6b3ff9c4 58443-0041 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20090105 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.4; 73.5; 49; 26.9; 19.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0042_22b0c855-d213-46a8-8b7a-1c051b47d4df 58443-0042 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.5; 76.1; 50.8; 27.5; 20.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0043_e4c2a921-3ae1-4abe-9bee-451034e88dd7 58443-0043 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131022 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.7; 74.3; 49.5; 27.2; 19.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0044_2b0f4307-a5eb-4ad0-8561-aa7da2ba81ba 58443-0044 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131227 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.8; 70.8; 47.2; 27.3; 19.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0045_b94fa7d0-b46b-4ad9-b061-69b63a75ce08 58443-0045 HUMAN OTC DRUG Panama Jack SPF 8 Oxtinoxate, and Oxybenzone SPRAY TOPICAL 20120110 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OXYBENZONE 19.8; 19.8 mg/mL; mg/mL N 20181231 58443-0046_79fa9d1b-0536-4c91-930f-ff21988b7471 58443-0046 HUMAN OTC DRUG Panama Jack SPF 15 Octinoxate, Octisalate, and Oxybenzone SPRAY TOPICAL 20130415 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 49.5; 29.7; 19.8 mg/mL; mg/mL; mg/mL N 20181231 58443-0047_422b0ae5-105e-47c7-b7f0-c57e31141178 58443-0047 HUMAN OTC DRUG Panama Jack SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20130517 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.8; 74.3; 49.5; 27.2; 19.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0048_1f581ad3-b7b9-4137-ae44-847a493ab5da 58443-0048 HUMAN OTC DRUG Panama Jack SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130318 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.7; 99; 49.5; 27.2; 19.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0049_ba93853c-e83b-490a-b95e-5da6599206dd 58443-0049 HUMAN OTC DRUG Panama Jack SPF 4 Octinoxate SPRAY TOPICAL 20131227 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE 19.8 mg/mL N 20181231 58443-0050_96e504c8-1320-4762-9062-73cb9e603650 58443-0050 HUMAN OTC DRUG Panama Jack SPF 8 Octinoxate, and Oxybenzone SPRAY TOPICAL 20130218 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OXYBENZONE 19.5; 19.5 mg/mL; mg/mL N 20181231 58443-0051_dd35b72e-6a10-4b34-868a-7ef6bf8dd7f9 58443-0051 HUMAN OTC DRUG Panama Jack SPF 8 Octinoxate, and Oxybenzone LOTION TOPICAL 20130125 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OXYBENZONE 19.5; 19.5 mg/mL; mg/mL N 20181231 58443-0052_8ee17de1-17fc-477d-9217-05fb9b0e810e 58443-0052 HUMAN OTC DRUG Panama Jack SPF 15 Octinoxate, Octisalate and Oxybenzone SPRAY TOPICAL 20130225 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 48.4; 29; 19.3 mg/mL; mg/mL; mg/mL N 20181231 58443-0053_0a074b7d-dbdf-49bb-9d2b-058622808115 58443-0053 HUMAN OTC DRUG Panama Jack BOAD SPECTRUM SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20130525 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.4; 73.4; 48.9; 26.9; 19.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0054_56989b72-beda-42d4-9918-c5d06e6d7c31 58443-0054 HUMAN OTC DRUG Panama Jack BOAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20130418 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.7; 99; 49.5; 27.2; 19.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0055_231db6b8-6aca-4d35-95bd-316709b9a409 58443-0055 HUMAN OTC DRUG Panama Jack SPF 15 Octinoxate, Octisalate, and Oxybenzone SPRAY TOPICAL 20131215 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 40.8; 24.5; 16.3 mg/mL; mg/mL; mg/mL N 20181231 58443-0057_74993e3e-1569-49f7-99d2-f8c012a922a4 58443-0057 HUMAN OTC DRUG Panama Jack BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20131126 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.5; 85; 42.5; 23.4; 34 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0058_870a3bd8-c366-4332-875b-b5219a686fef 58443-0058 HUMAN OTC DRUG Panama Jack BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20131126 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.5; 85; 16.3; 16.3; 16.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0060_5c438454-f2d7-44ca-b4ec-4536e472f7e2 58443-0060 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130204 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.8; 74.3; 49.6; 27.3; 19.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0061_554afe59-18da-4dc8-b709-bd7e6b46eb37 58443-0061 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130204 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 19.8; 74.3; 49.6; 27.3; 19.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0062_449bd141-95d9-4f8b-8e0d-bef7e8473a88 58443-0062 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130502 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.4; 97.9; 48.9; 26.9; 19.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0063_90f4a735-a4f7-4d81-974e-2577b0b9dada 58443-0063 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130131 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.4; 97.9; 48.9; 26.9; 19.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0064_93f1491e-13f2-4f0f-af4d-a8c1d1667f3a 58443-0064 HUMAN OTC DRUG Panama Jack SPF 8 Octinoxate and Oxybenzone OIL TOPICAL 20130202 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OXYBENZONE 16.7; 16.7 mg/mL; mg/mL N 20181231 58443-0065_f91333f6-96e7-483f-b55a-801eba8f699a 58443-0065 HUMAN OTC DRUG Panama Jack SPF 4 Octinoxate OIL TOPICAL 20130112 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE 19.3 mg/mL N 20181231 58443-0066_e68a519c-2c92-4bd6-ae59-c20addabefb5 58443-0066 HUMAN OTC DRUG Panama Jack SPF 4 Octinoxate OIL TOPICAL 20130124 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE 16.8 mg/mL N 20181231 58443-0068_27bd9ead-7816-46be-b9b9-00dc30c73579 58443-0068 HUMAN OTC DRUG Panama Jack SPF 30 Titanium Dioxide LOTION TOPICAL 20130204 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. TITANIUM DIOXIDE 102 mg/mL N 20181231 58443-0069_4afb2c44-db95-413c-ad6a-30adafa6a3cf 58443-0069 HUMAN OTC DRUG Panama Jack SPF 30 Titanium Dioxide LOTION TOPICAL 20130204 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. TITANIUM DIOXIDE 76.5 mg/mL N 20181231 58443-0070_3a11abd8-498e-4167-9251-865d6043c3c2 58443-0070 HUMAN OTC DRUG Australian Gold BOAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20131106 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.4; 101.4; 50.7; 27.9; 40.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0071_67d497b3-0376-4e25-b961-908a9073b41c 58443-0071 HUMAN OTC DRUG Australian Gold BOAD SPECTRUM SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20131106 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25.1; 62.7; 41.8; 22.9; 16.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0072_2a7effd1-bad0-4001-8e71-29224c7a79ec 58443-0072 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 15 Avobenzone, Octisalate and Octocrylene LOTION TOPICAL 20131031 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 16.2; 40.5; 14.9 mg/mL; mg/mL; mg/mL N 20181231 58443-0073_d1d07b75-a9b8-4772-a1e7-b13046813a89 58443-0073 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Octocrylene LOTION TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.1; 100.3; 50.2; 27.6; 40.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0074_ead2c8ca-6915-426b-8ca5-d129aa5d2fac 58443-0074 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 8 Avobenzone, Octisalate, Octocrylene and Oxybenzone GEL TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 9.7; 28.9; 27.6; 40.1 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0075_c599cb74-5c90-4a12-b543-aec53563caa5 58443-0075 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 8 Avobenzone, Octisalate, Octocrylene and Oxybenzone GEL TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 8.4; 25.1; 7.1; 8.4 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0076_2cc107bb-5d39-4ca8-adb5-914fc80ea718 58443-0076 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 4 Avobenzone, Octocrylene and Oxybenzone GEL TOPICAL 20131121 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 9.8; 8.3; 4.9 mg/mL; mg/mL; mg/mL N 20181231 58443-0077_c4d06114-f216-47f9-9889-d674fa95f25a 58443-0077 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20131125 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.7; 74.3; 49.5; 27.2; 19.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0078_fc314045-41d3-4514-8444-eff7e69291b7 58443-0078 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 15 Avobenzone, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20131114 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 50; 18.5; 5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0079_0e0535e4-5273-42b9-9857-3a95c6a4ecd9 58443-0079 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.1; 100.3; 50.2; 27.6; 40.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0080_4f065123-2566-4e96-8dea-1ceb6fb079aa 58443-0080 HUMAN OTC DRUG California Tan BROAD SPECTRUM SPF 4 Avobenzone, Octocrylene and Oxybenzone LOTION TOPICAL 20131209 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 4.79; 9.58; 4.79 mg/mL; mg/mL; mg/mL N 20181231 58443-0081_351fb3c9-14ac-48d7-95ea-51788b7ba6a3 58443-0081 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF30 Tianium Dioxide and Zinc Oxide LOTION TOPICAL 20131212 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. TITANIUM DIOXIDE; ZINC OXIDE 29.8; 39.7 mg/mL; mg/mL N 20181231 58443-0082_5214eb0a-ce17-4535-9ae3-1f368e04d43d 58443-0082 HUMAN OTC DRUG California Tan BROAD SPECTRUM SPF 8 Avobenzone, Octocrylene, and Oxybenzone LOTION TOPICAL 20131209 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 4.9; 19.6; 14.7 mg/mL; mg/mL; mg/mL N 20181231 58443-0083_8a92771e-94da-43fe-ad06-286c60e555e8 58443-0083 HUMAN OTC DRUG Australian Gold Hello Kitty BROAD SPECTRUM SPF 45 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20131223 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. TITANIUM DIOXIDE; ZINC OXIDE 45.45; 40.4 mg/mL; mg/mL N 20181231 58443-0088_6c758679-3b6e-4da4-bc51-83eeb6047e2b 58443-0088 HUMAN OTC DRUG Australian Gold Exotic Blend spf8 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20131217 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 9.9; 29.6; 8.4; 9.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0092_a2c6fb5c-97fd-4d41-b9a1-74082c372ffb 58443-0092 HUMAN OTC DRUG Baby blanket BROAD SPECTRUM SPF 50 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20131223 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 77.2; 51.5; 20.6; 30.9; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0093_c987dc8d-f8cf-425c-9ca8-c386c8532c1b 58443-0093 HUMAN OTC DRUG Baby blanket BROAD SPECTRUM SPF 50 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20130107 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 77.2; 51.5; 20.6; 30.9; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0094_1888e22b-fb8c-4dad-88f5-155ece317219 58443-0094 HUMAN OTC DRUG Baby Blanket BROAD SPECTRUM SPF 50 Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20130107 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 77.25; 51.5; 20.6; 30.9; 41.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0095_cd01811e-9ef9-45e0-9645-8dffb628b605 58443-0095 HUMAN OTC DRUG California Tan BROAD SPECTRUM SPF 15 Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 19.3; 48.2; 26.5 mg/mL; mg/mL; mg/mL N 20181231 58443-0096_ed5af5ed-eb3e-47b8-813c-1c6522f199f4 58443-0096 HUMAN OTC DRUG California Tan BROAD SPECTRUM SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.6; 73.9; 49.3; 27.1; 19.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0097_0277eae2-6c15-446b-9aaa-a6022e9480ce 58443-0097 HUMAN OTC DRUG California Tan BROAD SPECTRUM SPF 45 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130404 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.9; 99.8; 49.9; 27.5; 19.9 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0098_c256ac97-554e-4cf5-afbd-754e9cac3042 58443-0098 HUMAN OTC DRUG Suntone BROAD SPECTRUM SPF 4 Octinoxate SPRAY TOPICAL 20130318 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE 16.7 mg/mL N 20181231 58443-0100_dc274a6f-78d5-4f09-b5b4-e39e9d79340f 58443-0100 HUMAN OTC DRUG Suntone BROAD SPECTRUM SPF 4 Avobenzone, Octocrylene LOTION TOPICAL 20130204 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE 9.9; 8.4 mg/mL; mg/mL N 20181231 58443-0101_2ae8294b-a8f6-4f93-b2bf-5d2a65191b45 58443-0101 HUMAN OTC DRUG Sol Mate BROAD SPECTRUM SPF 4 Octinoxate SPRAY TOPICAL 20130204 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE 16.7 mg/mL N 20181231 58443-0102_7a95fc25-4beb-4a4f-af93-2649548807d9 58443-0102 HUMAN OTC DRUG Sunzen BROAD SPECTRUM SPF 8 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130326 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 9.9; 29.9; 8.5; 9.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0103_8869923c-8179-4a61-9970-2aadb88df4e8 58443-0103 HUMAN OTC DRUG Suntone SUNSCREEN BROAD SPECTRUM SPF 45 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130228 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE; OCTISALATE 9.94; 8.449; 9.94; 29.84 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0104_3d1413d0-1d00-4b1b-8334-b07568157ae2 58443-0104 HUMAN OTC DRUG SolMate BROAD SPECTRUM SPF 8 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130228 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE; OCTISALATE 9.94; 8.449; 9.94; 29.84 mg/mL; mg/mL; mg/mL; 1/mL N 20181231 58443-0105_454d10c9-8de2-4589-b19c-198222d5fb5c 58443-0105 HUMAN OTC DRUG SolMate BROAD SPECTRUM SPF 15 Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20130828 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 19.86; 49.65; 18.3705 mg/mL; mg/mL; mg/mL N 20181231 58443-0106_c34db2db-c65a-446d-bcae-a587de69274a 58443-0106 HUMAN OTC DRUG Suntone BROAD SPECTRUM SPF 15 Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20130228 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 20; 50; 18.5 mg/mL; mg/mL; mg/mL N 20181231 58443-0107_7cf2df5a-4730-4120-9112-616b414aee89 58443-0107 HUMAN OTC DRUG MAX BLOCK SPF 30 kids SUNSCREEN Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20130304 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 74.25; 49.5; 39.6 mg/mL; mg/mL; mg/mL N 20181231 58443-0108_9b6e70dd-953b-464a-a18f-3e92c15af876 58443-0108 HUMAN OTC DRUG MAX BLOCK SPF 30 SUNSCREEN Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20130131 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 74.25; 49.5; 39.6 mg/mL; mg/mL; mg/mL N 20181231 58443-0109_048b2471-68d8-4930-b040-281cbbd01b5d 58443-0109 HUMAN OTC DRUG MAX BLOCK SPF 30 SUNSCREEN SPORT Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20130315 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 76.5; 51; 40.8 mg/mL; mg/mL; mg/mL N 20181231 58443-0110_835e9d78-c246-4453-976a-c2f7160fa517 58443-0110 HUMAN OTC DRUG SolMate BROAD SPECTRUM SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130319 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 75; 50; 27.5; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0111_45c22616-5307-4c50-b8e1-f1e82a512d2d 58443-0111 HUMAN OTC DRUG ULTA Oil Free Sunscreen SPF30 Homosalate, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20130423 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 57; 71.25; 47.5; 38 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0112_f2be2088-7e9a-4fa5-bc36-93a46b61a76a 58443-0112 HUMAN OTC DRUG MAX BLOCK SPF 30 Baby SUNSCREEN Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20130321 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 74.25; 49.5; 39.6 mg/mL; mg/mL; mg/mL N 20181231 58443-0113_11e7644e-546b-4272-a886-5ea800384f6b 58443-0113 HUMAN OTC DRUG Sunzen BROAD SPECTRUM SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130404 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.94; 74.85; 49.9; 27.445; 19.96 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0114_20c651aa-2b13-41b2-83b1-ca6636f0c085 58443-0114 HUMAN OTC DRUG Sunzen BROAD SPECTRUM SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130404 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.94; 74.85; 49.9; 27.445; 19.96 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0115_cd6942f3-4729-4b77-9486-be7d26d541a4 58443-0115 HUMAN OTC DRUG SolMate Kids BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130228 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 275; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0117_b5671d2d-aba4-4072-ba97-f3a9313d5ba8 58443-0117 HUMAN OTC DRUG SolMate BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130228 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 275; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0118_8abebaba-460a-4d81-8045-cfd47c93a47a 58443-0118 HUMAN OTC DRUG SUNZEN BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130228 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 275; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0119_a4c179f8-a40b-4919-aa73-f71c378b3660 58443-0119 HUMAN OTC DRUG SUNZEN BROAD SPECTRUM SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20130228 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 275; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0123_2c26e249-265a-6214-e054-00144ff88e88 58443-0123 HUMAN OTC DRUG Lidocaine Plus Maximum Strength Pain Relieving Cream Lidocaine Hydrochloride CREAM TOPICAL 20070302 OTC MONOGRAPH FINAL part346 Prime Enterprises Inc. LIDOCAINE HYDROCHLORIDE 39.2 mg/mL N 20181231 58443-0125_2bea69f1-95ce-4fd8-e054-00144ff8d46c 58443-0125 HUMAN OTC DRUG Suntone After Sun Burn Relief Gel with Lidocaine Lidocaine Hydrochloride GEL TOPICAL 20111107 OTC MONOGRAPH FINAL part346 Prime Enterprises Inc. LIDOCAINE HYDROCHLORIDE 7.13 mg/mL N 20181231 58443-0126_9d78c139-77a2-496d-bf46-fd242f3fca7b 58443-0126 HUMAN OTC DRUG Ulta SUNSCREEN SPF 15 Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20070312 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 46.5; 27.9; 18.6 mg/mL; mg/mL; mg/mL N 20181231 58443-0127_069bd52a-8dc6-49eb-863e-20b7d616d721 58443-0127 HUMAN OTC DRUG Ulta SPF 15 Light Medium Broad Spectrum Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 19; 47.5; 23.75 mg/mL; mg/mL; mg/mL N 20181231 58443-0128_3a1e2af2-ff35-481a-b5a0-b76b83218d7f 58443-0128 HUMAN OTC DRUG Ulta Broad Spectrum SPF 15 Medium Deep Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20081126 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 19.2; 48; 24 mg/mL; mg/mL; mg/mL N 20181231 58443-0129_c1908946-0a8a-445f-9a80-47b843525dd1 58443-0129 HUMAN OTC DRUG Ulta SUNSCREEN SPF 45 Octinoxate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20070312 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 71.25; 47.5; 76; 57 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0130_6d45ee32-b4eb-4e53-92f0-f5d874b1dc62 58443-0130 HUMAN OTC DRUG Ulta Broad Spectrum SUNSCREEN SPF80 Avobezone, Enzulizole, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 Prime Enterprises, Inc. AVOBENZONE; ENSULIZOLE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28.2; 9.4; 141; 47; 25.85; 37.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0131_5dabb20b-1ac4-4a17-a7b2-a7fa381f2aec 58443-0131 HUMAN OTC DRUG Ulta SPF 15 Medium Deep Broad Spectrum tinted sunscreen Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20131125 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 19.6; 49; 18.13 mg/mL; mg/mL; mg/mL N 20181231 58443-0132_ba6a4693-9ded-4f02-addb-13583d32503e 58443-0132 HUMAN OTC DRUG Ulta SPF 15 Broad Spectrum Tinted Sunless Sunscreen for Face Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20131125 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 19.44; 48.6; 17.982 mg/mL; mg/mL; mg/mL N 20181231 58443-0133_51b4d1ce-0b7c-4da5-a59f-edd155413e81 58443-0133 HUMAN OTC DRUG Ulta SPF 15 Broad Spectrum Light to Medium Tinted Sunless Sunscreen Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20130826 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 19.6; 49; 18.13 mg/mL; mg/mL; mg/mL N 20181231 58443-0134_6d9c3909-af6f-4ab9-ae75-c04bfbd6670e 58443-0134 HUMAN OTC DRUG Ulta SPF 20 Broad Spectrum Water Resistant Sunscren with Shimmer Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20120920 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 19.6; 49; 18.13 mg/mL; mg/mL; mg/mL N 20181231 58443-0135_2b87aa05-7feb-1b46-e054-00144ff8d46c 58443-0135 HUMAN OTC DRUG Suntone Broad Spectrum SPF 50 Sunscreen Avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 20140317 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27.5; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0136_de11cfb9-86db-473b-9daf-5c179e6cb4ff 58443-0136 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 50 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20141118 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. ZINC OXIDE; TITANIUM DIOXIDE 40.4; 45.45 mg/mL; mg/mL N 20181231 58443-0137_b0b58efb-d586-492b-9958-1e71a69eb6c9 58443-0137 HUMAN OTC DRUG Australian Gold Aloe Freeze Gel with Lidocaine Lidocaine Hydrochloride GEL TOPICAL 20140609 OTC MONOGRAPH NOT FINAL part348 Prime Enterprises, Inc. LIDOCAINE 4.1 mg/mL N 20181231 58443-0138_2b87aaa6-97b9-3765-e054-00144ff88e88 58443-0138 HUMAN OTC DRUG Suntone Kids Broad Spectrum SPF 50 Sunscreen Avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 20140317 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27.5; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0139_2c9fb0c3-d4fe-31fb-e054-00144ff88e88 58443-0139 HUMAN OTC DRUG Solmate BROAD SPECTRUM SPF 50 Sport Sunscreen avobenzone, homosalate, octisalate, octocrylene and oxybenzone LOTION TOPICAL 20150309 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.7; 29.7; 99; 49.5; 27.23 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0140_6a1c785c-6bd1-4c33-a06e-186ddb3fc1cd 58443-0140 HUMAN OTC DRUG SolMate Baby Broad Spectrum SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140331 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.7; 99; 49.5; 27.225; 29.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0144_5b0f7095-4117-4742-8f7b-137881f533b6 58443-0144 HUMAN OTC DRUG SolMate Baby Broad Spectrum SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140410 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.7; 99; 49.5; 27.225; 29.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0145_3233143b-9dd6-4dd1-b46d-e6765eb44074 58443-0145 HUMAN OTC DRUG Solmate Burn Relief Gel Lidocaine Hydrochloride GEL TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part348 Prime Enterprises, Inc. LIDOCAINE .057 mg/mL N 20181231 58443-0147_81eceb9e-dc6e-42fe-a63c-b15c96c686e8 58443-0147 HUMAN OTC DRUG BLI Holdings MIAMI BEACH Kids spf 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20150301 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.7; 99; 49.5; 27.225; 29.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0148_d2447cb4-c343-4157-be26-3a8a239bc024 58443-0148 HUMAN OTC DRUG Raydiant By Australian Gold Vitamin D Broad Spectrum spf 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20150401 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 75; 50; 27.5; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0149_d8af81b0-3c04-4160-98e2-3ff2b2587471 58443-0149 HUMAN OTC DRUG Raydiant By Australian Gold Vitamin D Broad Spectrum spf 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20150401 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.7; 99; 49.5; 27.225; 29.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0150_78f35864-bf25-4fde-9a8a-f689acfddb66 58443-0150 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Avobenzone, Octisalate, Octocrylene, and Oxybenzone GEL TOPICAL 20150401 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 29.4; 73.5; 49; 26.95; 19.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0151_135c5cc2-e703-41ee-afe3-59948e09ae87 58443-0151 HUMAN OTC DRUG Fair and Square Kids Sunscreen SPF 50 Homosalate, Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20140319 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 149.7; 74.85; 49.9; 23.952 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0152_c6559bdd-ea3a-43d8-8d0d-21ff3a6fd693 58443-0152 HUMAN OTC DRUG Fair and Square Sport Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140312 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 15; 150; 50; 12.5; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0153_23a76de6-844e-4c8d-94a1-0893e09cbbe3 58443-0153 HUMAN OTC DRUG Fair and Square Ultra Protection Sunscreen SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20140312 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 19.5; 97.5; 48.75; 48.75 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0154_4359a7a8-22b5-4032-83b6-9c867a2451aa 58443-0154 HUMAN OTC DRUG Fair and Square Sport Sunscreen SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140313 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 9.8; 98; 49; 7.84; 39.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0155_0e654f51-0723-400a-b384-96a38b8387c8 58443-0155 HUMAN OTC DRUG Fair and Square Ultra Protection Sunscreen SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20140312 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.67; 98.9; 49.45; 98.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0159_29c8cb02-25c3-0a43-e054-00144ff88e88 58443-0159 HUMAN OTC DRUG Panama Jack Broad Spectrum SPF 15 Sport avobenzone, octisalate, and octocrylene LOTION TOPICAL 20001111 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 19.6; 49; 18.13 mg/mL; mg/mL; mg/mL N 20181231 58443-0161_40b92e12-8e19-4fd7-e054-00144ff88e88 58443-0161 HUMAN OTC DRUG California Tan SPF 45 Sunscreen avobenzone, homosalate, octisalate, octocrylene and oxybenzone LOTION TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 30; 100; 50; 27.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0167_8e15ef72-30f5-464c-afcc-01498370216d 58443-0167 HUMAN OTC DRUG Australian Gold Carrot Oil Formula Broad Spectrum SPF 4 Avobenzone, Octocrylene, Oxybenzone SPRAY TOPICAL 20140305 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 9; 7.65; 4.5 mg/mL; mg/mL; mg/mL N 20181231 58443-0169_38147f3c-962a-03bd-e054-00144ff88e88 58443-0169 HUMAN OTC DRUG California Tan SPF 15 Sunscreen Avobenzone, Octisalate, Octocrylene LOTION TOPICAL 20151230 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 20; 50; 18.5 mg/mL; mg/mL; mg/mL N 20181231 58443-0174_3b2bf548-a9a4-4f39-bdde-3ecd454eee88 58443-0174 HUMAN OTC DRUG Oscar Anti Perspirant Deodorant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20150401 OTC MONOGRAPH FINAL part350 Prime Enterprises, Inc. ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY .2 g/g N 20181231 58443-0175_c161f5dc-7705-44f0-af30-7248f04aeb25 58443-0175 HUMAN OTC DRUG SolScents Clear Face Flower Blast Broad Spectrum spf 50 Octinoxate, Octisalate, and Zinc Oxide LOTION TOPICAL 20150401 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 76.5; 51; 45.9 mg/mL; mg/mL; mg/mL N 20181231 58443-0177_2b70d706-35b1-29da-e054-00144ff8d46c 58443-0177 HUMAN OTC DRUG Australian Gold SPF 15 Sheer Coverage Sunscreen Avobenzone, octocrylene, and octisalate LOTION TOPICAL 20140228 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; OCTOCRYLENE; OCTISALATE 18.8; 17.4; 47 mg/mL; mg/mL; mg/mL N 20181231 58443-0179_a67e7a47-ea94-4aa5-bff9-7daa55d37b79 58443-0179 HUMAN OTC DRUG Panama Jack 30 Broad Spectrum SPF 30 Clear Zinc Octinoxate, Octisalate, Octocrylene, and Zinc Oxide LOTION TOPICAL 20111229 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 49.35; 49.35; 19.74; 29.61 mg/mL; 1/mL; 1/mL; mg/mL N 20181231 58443-0180_0500ce93-e6ee-4d80-aaec-b556fa8a0f6e 58443-0180 HUMAN OTC DRUG Australian Gold Defense Zone Anti-Dandruff Step 2 Pyrithione Zinc SHAMPOO TOPICAL 20150601 OTC MONOGRAPH FINAL part358H Prime Enterprises, Inc. PYRITHIONE ZINC 10.32 mg/mL N 20181231 58443-0181_cc4c7416-079b-4267-9811-4c9fe9e73d8e 58443-0181 HUMAN OTC DRUG Australian Gold Defense Zone Anti-dandruff Leave-in Treatment Pyrithione Zinc SHAMPOO TOPICAL 20150601 OTC MONOGRAPH FINAL part358H Prime Enterprises, Inc. PYRITHIONE ZINC 2.14 mg/mL N 20181231 58443-0182_bd411844-dae0-45d3-b665-609d9b1c38a9 58443-0182 HUMAN OTC DRUG LifeCell bb cream Hydrating Anti-Oxidant Beauty Balm Broad Spectrum SPF 30 light Octinoxate and Zinc Oxide LOTION TOPICAL 20140116 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; ZINC OXIDE 29.19; 29.19 mg/mL; mg/mL N 20181231 58443-0183_d6522df2-de6a-4d1e-92d1-2c25a3f24e54 58443-0183 HUMAN OTC DRUG LifeCell bb cream Hydrating Anti-Oxidant Beauty Balm Broad Spectrum SPF 30 medium Octinoxate and Zinc Oxide LOTION TOPICAL 20130813 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. OCTINOXATE; ZINC OXIDE 29.4; 29.4 mg/mL; mg/mL N 20181231 58443-0184_cdb47148-7d6a-41b6-bc08-7cc68a1e223e 58443-0184 HUMAN OTC DRUG Australian Gold Defense Zone Anti-dandruff Leave-in Treatment Pyrithione Zinc LOTION TOPICAL 20150801 OTC MONOGRAPH FINAL part358H Prime Enterprises, Inc. PYRITHIONE ZINC 2.14 mg/mL N 20181231 58443-0185_335c211d-a782-4edb-a085-1a9cee38a49f 58443-0185 HUMAN OTC DRUG Soleil Toujours Perpetual Radiance Broad Spectrum SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20150716 OTC MONOGRAPH FINAL part352 Prime Enterprises, Inc. TITANIUM DIOXIDE; ZINC OXIDE 17.6; 41.2 mg/mL; mg/mL N 20181231 58443-0186_3f067242-13d0-4ed3-9704-3bdb026fd7ea 58443-0186 HUMAN OTC DRUG Australian Gold Defense Zone Anti-dandruff Leave-in Treatment Pyrithione Zinc LOTION TOPICAL 20150801 OTC MONOGRAPH FINAL part358H Prime Enterprises, Inc. PYRITHIONE ZINC 2.14 mg/mL N 20181231 58443-0187_20d42d7e-7124-299b-e054-00144ff88e88 58443-0187 HUMAN OTC DRUG Coral Actives 2 Step Acne Treatment System Benzoyl Peroxide GEL TOPICAL 20130312 OTC MONOGRAPH FINAL part333D Prime Enterprises Inc. BENZOYL PEROXIDE 61.62 mg/mL N 20181231 58443-0188_206b7941-9530-5623-e054-00144ff8d46c 58443-0188 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 30 Sunscreen avobenzone, homosalate, octisalate, octocrylene and oxybenzone LOTION TOPICAL 20150210 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 30; 75; 50; 27.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0189_20d1ae33-e22a-55ea-e054-00144ff88e88 58443-0189 HUMAN OTC DRUG United Spirit of America BROAD SPECTRUM SPF 30 Sunscreen avobenzone, homosalate, octisalate, octocrylene, oxybenzone LOTION TOPICAL 20100804 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 19.2; 19.2; 72; 48; 26.4 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0190_20d2e1fd-5883-0477-e054-00144ff88e88 58443-0190 HUMAN OTC DRUG Destination Brands International BROAD SPECTRUM SPF 50 Sunscreen avobenzone, homosalate, octisalate, octocrylene and oxybenzone LOTION TOPICAL 20150113 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.7; 29.7; 99; 49.5; 27.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0191_20d47c70-36cb-0723-e054-00144ff8d46c 58443-0191 HUMAN OTC DRUG Lifecell BROAD SPECTRUM SPF 30 BB Cream Octinoxate and Zinc Oxide CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. ZINC OXIDE; OCTINOXATE 29.01; 29.01 mg/mL; mg/mL N 20181231 58443-0192_215e85c0-7a37-5bf7-e054-00144ff8d46c 58443-0192 HUMAN OTC DRUG Lifecell BROAD SPECTRUM SPF 30 BB Cream Octinoxate and Zinc Oxide CREAM TOPICAL 20140116 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. ZINC OXIDE; OCTINOXATE 29.2; 29.2 mg/mL; mg/mL N 20181231 58443-0193_216016fd-4054-2c9f-e054-00144ff8d46c 58443-0193 HUMAN OTC DRUG Lifecell BROAD SPECTRUM SPF 30 BB Cream Octinoxate and Zinc Oxide CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. ZINC OXIDE; OCTINOXATE 29.4; 29.4 mg/mL; mg/mL N 20181231 58443-0194_216188e3-96e0-1ef3-e054-00144ff88e88 58443-0194 HUMAN OTC DRUG Lifecell BROAD SPECTRUM SPF 50 BB SHEER Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20151005 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE; OXYBENZONE 27.5; 50; 30; 100; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0195_2185064e-163c-5a59-e054-00144ff8d46c 58443-0195 HUMAN OTC DRUG Abella ColorShade SPF 35 Medium Octinoxate and Zinc Oxide LOTION TOPICAL 20130801 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. ZINC OXIDE; OCTINOXATE 29.4; 29.4 mg/mL; mg/mL N 20181231 58443-0196_2185900a-84f1-142f-e054-00144ff88e88 58443-0196 HUMAN OTC DRUG Abella Color Shade SPF 35 Dark Octinoxate and Zinc Oxide LOTION TOPICAL 20130801 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. ZINC OXIDE; OCTINOXATE 29; 29 mg/mL; mg/mL N 20181231 58443-0197_2187db35-3637-5a06-e054-00144ff88e88 58443-0197 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 30 X-treme Sport Sunscreen avobenzone, homosalate, octisalate, octocrylene and oxybenzone LOTION TOPICAL 20151007 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 19.8; 29.7; 74.3; 49.5; 27.2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0198_219d8726-16db-096e-e054-00144ff88e88 58443-0198 HUMAN OTC DRUG The Good Stuff AfterShave SPF 15 Avobenzone, octocrylene, and octisalate CREAM TOPICAL 20151008 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; OCTOCRYLENE; OCTISALATE 20; 18.5; 50 mg/mL; mg/mL; mg/mL N 20181231 58443-0199_2390a3d3-2eea-0584-e054-00144ff88e88 58443-0199 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 50 X-treme Sport Sunscreen avobenzone, homosalate, octisalate, octocrylene and oxybenzone SPRAY TOPICAL 20151102 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 40.4; 30.33; 101.1; 50.55; 27.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0200_2391871d-cfd2-064e-e054-00144ff8d46c 58443-0200 HUMAN OTC DRUG Australian Gold Kids SPF 50 Sunscreen homosalate, octinoxate, octisalate and titanium dioxide LOTION TOPICAL 20151102 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. TITANIUM DIOXIDE; HOMOSALATE; OCTISALATE; OCTINOXATE 24.5; 102; 51; 76.5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0201_22b43c46-4cd5-0cbb-e054-00144ff88e88 58443-0201 HUMAN OTC DRUG Panama Jack SPF 4 Dark Tanning Oil Octinoxate OIL TOPICAL 20111215 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OCTINOXATE 2 g/100g N 20181231 58443-0202_2393ef7e-c7d9-07b4-e054-00144ff88e88 58443-0202 HUMAN OTC DRUG California Tan SPF 30 Sunscreen avobenzone, homosalate, octisalate, octocrylene and oxybenzone LOTION TOPICAL 20140402 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 30; 75; 50; 27.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0203_29c9cb6c-ef5d-3759-e054-00144ff88e88 58443-0203 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 30 Sheer Sunscreen avobenzone, homosalate, octisalate, octocrylene and oxybenzone LOTION TOPICAL 20140301 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20.4; 30.6; 76.5; 51; 28.1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0204_25eedcb5-f40b-2e9b-e054-00144ff8d46c 58443-0204 HUMAN OTC DRUG Panama Jack Burn Relief Gel with Lidocaine Lidocaine GEL TOPICAL 20151019 OTC MONOGRAPH FINAL part346 Prime Enterprises Inc. LIDOCAINE HYDROCHLORIDE 7.13 mg/mL N 20181231 58443-0205_26070fa2-4d3d-5d6e-e054-00144ff8d46c 58443-0205 HUMAN OTC DRUG Max Block Maz Block SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20151125 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 19.8; 19.8; 74.3; 49.5; 18.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0206_26143b41-3e26-1204-e054-00144ff8d46c 58443-0206 HUMAN OTC DRUG Max Block Maz Block SPF 50 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20151125 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 19.78; 19.78; 148.35; 49.45; 18.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0207_26167c2e-4b33-4562-e054-00144ff88e88 58443-0207 HUMAN OTC DRUG Max Block Maz Block SPF 30 Sport Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20151125 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 19.8; 19.8; 74.3; 49.5; 18.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0208_261630c5-5554-51e5-e054-00144ff8d46c 58443-0208 HUMAN OTC DRUG Max Block Maz Block SPF 50 Kids Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20151125 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 19.78; 19.78; 148.35; 49.45; 18.3 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0209_268fbc99-00fd-47bc-e054-00144ff88e88 58443-0209 HUMAN OTC DRUG Abella Color Shade SPF 35 Light Octinoxate and Zinc Oxide LOTION TOPICAL 20151130 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. ZINC OXIDE; OCTINOXATE 29.4; 29.4 mg/mL; mg/mL N 20181231 58443-0210_267f9ae8-ddfc-43c3-e054-00144ff88e88 58443-0210 HUMAN OTC DRUG Abella Color Shade SPF 35 Ebony Octinoxate and Zinc Oxide LOTION TOPICAL 20151130 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. ZINC OXIDE; OCTINOXATE 29.4; 29.4 mg/mL; mg/mL N 20181231 58443-0211_279395e9-afa3-5e04-e054-00144ff88e88 58443-0211 HUMAN OTC DRUG Concept II SolScents Broad Spectrum SPF 30 Deep Love avobenzone, homosalate, octisalate, octocrylene and oxybenzone LOTION TOPICAL 20130523 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 30; 75; 50; 27.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0212_27fb491a-02d9-60df-e054-00144ff88e88 58443-0212 HUMAN OTC DRUG Concept II SolScents Broad Spectrum SPF 30 Angelica avobenzone, homosalate, octisalate, octocrylene and oxybenzone LOTION TOPICAL 20130523 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20.2; 30.3; 75.75; 50.5; 27.8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0213_280a7d78-db7f-19a5-e054-00144ff8d46c 58443-0213 HUMAN OTC DRUG Concept II SolScents Broad Spectrum SPF 30 Cucumber Melon avobenzone, homosalate, octisalate, octocrylene and oxybenzone LOTION TOPICAL 20130523 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20.2; 30.3; 75.75; 50.5; 27.78 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0214_280ad32b-75b8-286e-e054-00144ff8d46c 58443-0214 HUMAN OTC DRUG Concept II SolScents Broad Spectrum SPF 15 Vanilla Silk avobenzone, octisalate, and octocrylene LOTION TOPICAL 20130520 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 20; 50; 18.5 mg/mL; mg/mL; mg/mL N 20181231 58443-0215_280bb216-30a0-4db9-e054-00144ff8d46c 58443-0215 HUMAN OTC DRUG Concept II SolScents Broad Spectrum SPF 15 Pina Colada avobenzone, octisalate, and octocrylene LOTION TOPICAL 20130520 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 20; 50; 18.5 mg/mL; mg/mL; mg/mL N 20181231 58443-0216_280ca6da-f74a-0c8b-e054-00144ff8d46c 58443-0216 HUMAN OTC DRUG Concept II SolScents Broad Spectrum SPF 50 Flower Blast avobenzone, homosalate, octisalate, octocrylene and oxybenzone LOTION TOPICAL 20130523 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 30; 125; 50; 27.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0217_280cec42-8f2e-1db8-e054-00144ff88e88 58443-0217 HUMAN OTC DRUG Concept II SolScents Broad Spectrum SPF 50 Raspberry Dreams avobenzone, homosalate, octisalate, octocrylene and oxybenzone LOTION TOPICAL 20130523 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 30; 125; 50; 27.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0218_280dccf1-955b-3e9d-e054-00144ff88e88 58443-0218 HUMAN OTC DRUG Australian Gold Baby SPF 50 Sunscreen homosalate, octinoxate, octisalate and titanium dioxide LOTION TOPICAL 20151102 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. TITANIUM DIOXIDE; HOMOSALATE; OCTISALATE; OCTINOXATE 25.5; 102; 51; 76.5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0219_39a99995-912f-6a39-e054-00144ff8d46c 58443-0219 HUMAN OTC DRUG Australian Gold Hello Kitty Mineral Faces Sunscreen Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20131223 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. ZINC OXIDE; TITANIUM DIOXIDE 41.6; 46.8 mg/mL; mg/mL N 20181231 58443-0220_29115ae7-413b-4b07-e054-00144ff88e88 58443-0220 HUMAN OTC DRUG Australian Gold Broad Spectrum SPF 4 Sunscreen Avobenzone, octocrylene, and oxybenzone LOTION TOPICAL 20150407 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; OCTOCRYLENE; OXYBENZONE 9.74; 8.28; 4.87 mg/mL; mg/mL; mg/mL N 20181231 58443-0221_2e5958cb-faf9-120e-e054-00144ff8d46c 58443-0221 HUMAN OTC DRUG Panama Jack SPF 85 Sport Dry Touch Sunscreen Avobenzone, homosalate, octisalate, octocrylene, and oxybenzone SPRAY TOPICAL 20111130 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 38.8; 29.1; 121.25; 48.5; 26.68 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0222_2b453a8d-cdfc-53ea-e054-00144ff88e88 58443-0222 HUMAN OTC DRUG Australian Gold Mermaid SPF 50 Glitter Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20160208 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 41.04; 30.78; 102.6; 51.3; 28.22 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0223_2bfa9375-aa3e-312a-e054-00144ff8d46c 58443-0223 HUMAN OTC DRUG Eternal Spirit Beauty Painless Pain Relieving Cream Menthol CREAM TOPICAL 20160129 OTC MONOGRAPH FINAL part346 Prime Enterprises Inc. MENTHOL 12.13 mg/mL N 20181231 58443-0224_2e58c48d-a94c-1986-e054-00144ff88e88 58443-0224 HUMAN OTC DRUG No-Ad Sun Care Broad Spectrum SPF 50 Kids Avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 20160317 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 50; 20; 100; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0225_2ea96f45-ad0d-1e21-e054-00144ff88e88 58443-0225 HUMAN OTC DRUG No-Ad Sun Care Broad Spectrum SPF 50 Baby Sunscreen Avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 20160317 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 48.8; 19.52; 97.6; 48.8; 19.52 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0226_2fc37534-011b-0615-e054-00144ff88e88 58443-0226 HUMAN OTC DRUG No-Ad Sun Care Broad Spectrum SPF 60 Sunscreen Avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 20160331 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 60; 25; 100; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0228_2fece884-7cae-0b1c-e054-00144ff88e88 58443-0228 HUMAN OTC DRUG Aloe Up Pro SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20160407 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 35 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0229_2ff9e8e9-b8a4-244e-e054-00144ff8d46c 58443-0229 HUMAN OTC DRUG No-Ad Sun Care Broad Spectrum SPF 30 Sunscreen Avobenzone, homosalate, octisalate, and oxybenzone LOTION TOPICAL 20160406 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE 30; 20; 100; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0230_2ff9e8e9-b8a2-244e-e054-00144ff8d46c 58443-0230 HUMAN OTC DRUG Aloe Up Pro SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20160407 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 35 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0231_339aa7f1-4f1c-43f7-e054-00144ff88e88 58443-0231 HUMAN OTC DRUG Defense Zone Sport Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160512 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 40; 10; 100; 50; 8 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0232_339d782e-6061-0c22-e054-00144ff8d46c 58443-0232 HUMAN OTC DRUG Defense Zone Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20160512 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.7; 98.9; 49.5; 98.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0233_33b2b7a3-e9e0-2815-e054-00144ff8d46c 58443-0233 HUMAN OTC DRUG Defense Zone Kids Broad Spectrum SPF 50 Sunscreen Homosalate, Octinoxate, Octisalate, Titanium Dioxide LOTION TOPICAL 20160509 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OCTINOXATE; HOMOSALATE; OCTISALATE; TITANIUM DIOXIDE 75.8; 151.5; 50.5; 24.2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0234_33becde4-0b58-3615-e054-00144ff8d46c 58443-0234 HUMAN OTC DRUG Defense Zone Sport Broad Spectrum SPF 50 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160513 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 60; 15; 150; 50; 13 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0235_33c0753f-5ec0-3780-e054-00144ff88e88 58443-0235 HUMAN OTC DRUG BullFrog SPF 50 Land Sport Quik Gel Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone GEL TOPICAL 20160429 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 54; 27; 135; 45; 90 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0236_33c51222-d0ee-11e3-e054-00144ff8d46c 58443-0236 HUMAN OTC DRUG Specter Capital Tropical Blend Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160531 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; OCTOCRYLENE; HOMOSALATE; OCTISALATE; AVOBENZONE 19.8; 27.3; 74.3; 49.6; 29.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0237_36f99b39-ece1-39d4-e054-00144ff88e88 58443-0237 HUMAN OTC DRUG Australian Gold Botanical Mineral Sunscreen Broad Spectrum SPF 50 Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20160715 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. ZINC OXIDE; TITANIUM DIOXIDE 43.04; 43.04 mg/mL; mg/mL N 20181231 58443-0238_36f97c68-6262-3617-e054-00144ff8d46c 58443-0238 HUMAN OTC DRUG Australian Gold Botanical Mineral Sunscreen Broad Spectrum SPF 30 Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20160715 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. ZINC OXIDE; TITANIUM DIOXIDE 31.02; 31.02 mg/mL; mg/mL N 20181231 58443-0239_36faaf2b-eb57-61f2-e054-00144ff88e88 58443-0239 HUMAN OTC DRUG Australian Gold Botanical Tinted Face Mineral Sunscreen Broad Spectrum SPF 50 Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20160715 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. ZINC OXIDE; TITANIUM DIOXIDE 43.04; 43.04 mg/mL; mg/mL N 20181231 58443-0240_3b87d291-a1a2-37ed-e054-00144ff8d46c 58443-0240 HUMAN OTC DRUG United Spirit of America Broad Spectrum SPF 50 Sunscreen Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20160816 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. TITANIUM DIOXIDE; ZINC OXIDE 44.6; 39.6 mg/mL; mg/mL N 20181231 58443-0241_46d92e62-9d2b-458f-e054-00144ff88e88 58443-0241 HUMAN OTC DRUG Australian Gold BROAD SPECTRUM SPF 15 Sunscreen Avobenzone, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20130814 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 4.92; 19.66; 49.15; 18.19 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0242_3f235977-62ce-08f5-e054-00144ff8d46c 58443-0242 HUMAN OTC DRUG Australian Gold Metro 365 Medicated 2 in 1 Anti-Dandruff Pyrithione Zinc 1% SHAMPOO TOPICAL 20161007 OTC MONOGRAPH FINAL part358H Prime Enterprises Inc. PYRITHIONE ZINC 10.32 mg/mL N 20181231 58443-0243_405720c0-99c2-1d6d-e054-00144ff8d46c 58443-0243 HUMAN OTC DRUG Australian Gold Metro 365 Medicated Leave-In Treatment Step 3 Pyrithione Zinc 0.22% CREAM TOPICAL 20161012 OTC MONOGRAPH FINAL part358H Prime Enterprises Inc. PYRITHIONE ZINC 2.14 mg/mL N 20181231 58443-0244_44aa37e6-e697-022a-e054-00144ff88e88 58443-0244 HUMAN OTC DRUG Ulta Beauty Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20161227 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE 50.5; 20.2; 27.78; 30.3; 75.75 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0245_45ae9cae-f903-5ebd-e054-00144ff88e88 58443-0245 HUMAN OTC DRUG Ulta Beauty Broad Spectrum SPF 30 Tinted Mineral Sunscreen Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20161227 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. TITANIUM DIOXIDE; ZINC OXIDE 31.38; 31.38 mg/mL; mg/mL N 20181231 58443-0246_4d72d38f-aaa9-1f57-e054-00144ff88e88 58443-0246 HUMAN OTC DRUG Hair Sanity Hair Sanity Part I Hydrocortisone acetate LOTION/SHAMPOO TOPICAL 20170418 OTC MONOGRAPH NOT FINAL part348 Prime Enterprises Inc. HYDROCORTISONE ACETATE 5 mg/mL N 20181231 58443-0250_56f62eea-8681-5beb-e054-00144ff8d46c 58443-0250 HUMAN OTC DRUG Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20170818 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.46; 98.2; 49.1; 27.01 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0251_5b48c63b-a4b9-7c36-e053-2a91aa0a843a 58443-0251 HUMAN OTC DRUG Australian Gold SPF 50 Sunscreen with Instant Bronzer Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY TOPICAL 20171011 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 29.73; 99.1; 49.55; 27.25 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58443-0252_5d678911-a6d7-9403-e053-2a91aa0a3c5c 58443-0252 HUMAN OTC DRUG Australian Gold Botanical Sunscreen SPF 50 Kids Broad Spectrum Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20171107 OTC MONOGRAPH FINAL part352 Prime Enterprises Inc. ZINC OXIDE; TITANIUM DIOXIDE 42.2; 42.2 mg/mL; mg/mL N 20181231 58463-011_99ebc5e5-5cfc-48c6-bb7f-38249a59a9ea 58463-011 HUMAN PRESCRIPTION DRUG KEFLEX CEPHALEXIN CAPSULE ORAL 20160501 NDA NDA050405 Pragma Pharmaceuticals, LLC CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 58463-012_99ebc5e5-5cfc-48c6-bb7f-38249a59a9ea 58463-012 HUMAN PRESCRIPTION DRUG KEFLEX CEPHALEXIN CAPSULE ORAL 20160501 NDA NDA050405 Pragma Pharmaceuticals, LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 58463-013_99ebc5e5-5cfc-48c6-bb7f-38249a59a9ea 58463-013 HUMAN PRESCRIPTION DRUG KEFLEX CEPHALEXIN CAPSULE ORAL 20160501 NDA NDA050405 Pragma Pharmaceuticals, LLC CEPHALEXIN 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 58466-024_0f895e98-07ff-42c9-9e2a-17f6e328dae5 58466-024 HUMAN OTC DRUG nanocare Dimethicone CREAM TOPICAL 20121015 OTC MONOGRAPH NOT FINAL part332 Deramzone Solutions, Inc. DIMETHICONE 10 mg/mL E 20171231 58466-033_4d7b98e6-4b6a-461b-8735-7d889c233685 58466-033 HUMAN OTC DRUG nanocare Moisturizing Sunscreen SPF 50 Benzophenone, Avobenzone, Octisalate, Homosalate, and Octocrylene LOTION TOPICAL 20121015 OTC MONOGRAPH FINAL part352 Deramzone Solutions, Inc. BENZOPHENONE; AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 60; 30; 50; 100; 80 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 58466-108_0b3bb21f-d3e0-48a0-b76a-5805c14bf788 58466-108 HUMAN OTC DRUG celazome Moisturizing SPF 29 Active with DNArescue OXYBENZONE, OCTINOXATE, OCTISALATE, and HOMOSALATE CREAM TOPICAL 20151001 OTC MONOGRAPH FINAL part352 Dermazone Solutions, Inc. OXYBENZONE; OCTINOXATE; OCTISALATE; HOMOSALATE 60; 75; 50; 50 mg/g; mg/g; mg/g; mg/g N 20181231 58466-901_1ee51e96-a927-43de-a871-80a0bc7b1041 58466-901 HUMAN OTC DRUG celazome Moisturizing SPF 30 Active OXYBENZONE, OCTINOXATE, OCTISALATE, and HOMOSALATE CREAM TOPICAL 20151001 OTC MONOGRAPH FINAL part352 Dermazone Solutions, Inc. OXYBENZONE; OCTINOXATE; OCTISALATE; HOMOSALATE 50; 75; 50; 50 mg/g; mg/g; mg/g; mg/g N 20181231 58468-0020_f1857051-5b77-4208-8cd2-bec920b2eb02 58468-0020 HUMAN PRESCRIPTION DRUG Renagel Renagel TABLET ORAL 20080606 NDA NDA021179 Genzyme Corporation SEVELAMER HYDROCHLORIDE 400 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 58468-0021_f1857051-5b77-4208-8cd2-bec920b2eb02 58468-0021 HUMAN PRESCRIPTION DRUG Renagel Renagel TABLET ORAL 20080606 NDA NDA021179 Genzyme Corporation SEVELAMER HYDROCHLORIDE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 58468-0030_b0abb052-43c3-4127-a87a-efe2a77bcb36 58468-0030 HUMAN PRESCRIPTION DRUG Thyrogen THYROTROPIN ALFA INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 19981130 NDA NDA020898 Genzyme Corporation THYROTROPIN ALFA .9 mg/mL Thyroid Stimulating Hormone [EPC],Thyrotropin [Chemical/Ingredient] N 20181231 58468-0040_1062d32d-80a0-43eb-b5fa-78c3ea27504e 58468-0040 HUMAN PRESCRIPTION DRUG Fabrazyme AGALSIDASE BETA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081217 BLA BLA103979 Genzyme Corporation AGALSIDASE BETA 5 mg/mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC] N 20181231 58468-0041_1062d32d-80a0-43eb-b5fa-78c3ea27504e 58468-0041 HUMAN PRESCRIPTION DRUG Fabrazyme AGALSIDASE BETA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081217 BLA BLA103979 Genzyme Corporation AGALSIDASE BETA 5 mg/mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC] N 20181231 58468-0070_fd246901-36a5-4e84-9790-49741f4c109d 58468-0070 HUMAN PRESCRIPTION DRUG ALDURAZYME laronidase INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20030430 BLA BLA125058 Genzyme Corporation LARONIDASE 2.9 mg/5mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC] N 20181231 58468-0080_78c993d4-775d-49bb-ada0-d300078398a2 58468-0080 HUMAN PRESCRIPTION DRUG Thymoglobulin Anti-thymocyte Globulin (Rabbit) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19981230 BLA BLA103869 Genzyme Corporation LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN 5 mg/mL Immunoglobulin G [EPC],Lymphocyte Function Alteration [PE],Increased T Lymphocyte Destruction [PE],Antibody-Surface Protein Interactions [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 58468-0120_5dd79673-1791-4567-90bf-a31807e2f4e7 58468-0120 HUMAN PRESCRIPTION DRUG Hectorol doxercalciferol CAPSULE, LIQUID FILLED ORAL 20090803 NDA NDA020862 Genzyme Corporation DOXERCALCIFEROL .5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 58468-0121_5dd79673-1791-4567-90bf-a31807e2f4e7 58468-0121 HUMAN PRESCRIPTION DRUG Hectorol doxercalciferol CAPSULE, LIQUID FILLED ORAL 20090803 NDA NDA020862 Genzyme Corporation DOXERCALCIFEROL 2.5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 58468-0123_3deff505-3a52-47c1-b142-52f6ff546994 58468-0123 HUMAN PRESCRIPTION DRUG Hectorol DOXERCALCIFEROL INJECTION, SOLUTION INTRAVENOUS 20081208 NDA NDA021027 Genzyme Corporation DOXERCALCIFEROL 4 ug/2mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 58468-0124_5dd79673-1791-4567-90bf-a31807e2f4e7 58468-0124 HUMAN PRESCRIPTION DRUG Hectorol DOXERCALCIFEROL CAPSULE, LIQUID FILLED ORAL 20090803 NDA NDA020862 Genzyme Corporation DOXERCALCIFEROL 1 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 58468-0126_3deff505-3a52-47c1-b142-52f6ff546994 58468-0126 HUMAN PRESCRIPTION DRUG Hectorol DOXERCALCIFEROL INJECTION, SOLUTION INTRAVENOUS 20081208 NDA NDA021027 Genzyme Corporation DOXERCALCIFEROL 2 ug/mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 58468-0127_3deff505-3a52-47c1-b142-52f6ff546994 58468-0127 HUMAN PRESCRIPTION DRUG Hectorol DOXERCALCIFEROL INJECTION, SOLUTION INTRAVENOUS 20081208 NDA NDA021027 Genzyme Corporation DOXERCALCIFEROL 4 ug/2mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 58468-0130_357b2830-7b84-4088-b405-154597276f15 58468-0130 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20090812 NDA NDA022127 Genzyme Corporation SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 58468-0131_357b2830-7b84-4088-b405-154597276f15 58468-0131 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE POWDER, FOR SUSPENSION ORAL 20090812 NDA NDA022318 Genzyme Corporation SEVELAMER CARBONATE 2400 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 58468-0132_357b2830-7b84-4088-b405-154597276f15 58468-0132 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE POWDER, FOR SUSPENSION ORAL 20090812 NDA NDA022318 Genzyme Corporation SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 58468-0140_2b6cc6a4-9e7b-4066-9936-e23a753b7547 58468-0140 HUMAN PRESCRIPTION DRUG Mozobil PLERIXAFOR SOLUTION SUBCUTANEOUS 20081215 NDA NDA022311 Genzyme Corporation PLERIXAFOR 24 mg/1.2mL Hematopoietic Stem Cell Mobilizer [EPC],Increased Hematopoietic Stem Cell Mobilization [PE] N 20181231 58468-0150_d5c4c7bc-6ea9-43e9-83d4-09f842bb15e0 58468-0150 HUMAN PRESCRIPTION DRUG Myozyme ALGLUCOSIDASE ALFA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100619 BLA BLA125141 Genzyme Corporation ALGLUCOSIDASE ALFA 5 mg/mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC] N 20181231 58468-0160_dc1d77b8-40b5-4b38-a03e-1ebcbc7ac7d0 58468-0160 HUMAN PRESCRIPTION DRUG Lumizyme ALGLUCOSIDASE ALFA INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100524 BLA BLA125291 Genzyme Corporation ALGLUCOSIDASE ALFA 5 mg/mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC] N 20181231 58468-0191_37da4828-7c56-43a3-9c21-8781d5e7d0d2 58468-0191 HUMAN PRESCRIPTION DRUG Kynamro MIPOMERSEN SODIUM INJECTION, SOLUTION SUBCUTANEOUS 20130129 NDA NDA203568 Genzyme Corporation MIPOMERSEN SODIUM 200 mg/mL Apolipoprotein B-100 Synthesis Inhibitor [EPC],Decreased Protein Synthesis [PE],Antisense Oligonucleotide [EPC],Oligonucleotides, Antisense [Chemical/Ingredient] N 20181231 58468-0200_e8b30fec-882d-4855-b112-5dd68ac59239 58468-0200 HUMAN PRESCRIPTION DRUG LEMTRADA ALEMTUZUMAB INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20141118 BLA BLA103948 Genzyme Corporation ALEMTUZUMAB 12 mg/1.2mL CD52-directed Antibody Interactions [MoA],CD52-directed Cytolytic Antibody [EPC] N 20181231 58468-0210_18df263c-b55d-47bb-b2ea-1521c5244e5f 58468-0210 HUMAN PRESCRIPTION DRUG Aubagio teriflunomide TABLET, FILM COATED ORAL 20130501 NDA NDA202992 Genzyme Corp. TERIFLUNOMIDE 14 mg/1 Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA] N 20181231 58468-0211_18df263c-b55d-47bb-b2ea-1521c5244e5f 58468-0211 HUMAN PRESCRIPTION DRUG Aubagio teriflunomide TABLET, FILM COATED ORAL 20130501 NDA NDA202992 Genzyme Corp. TERIFLUNOMIDE 7 mg/1 Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA] N 20181231 58468-0220_7887c191-03db-4a18-9dea-b3907d0e9856 58468-0220 HUMAN PRESCRIPTION DRUG Cerdelga eliglustat CAPSULE ORAL 20140903 NDA NDA205494 Genzyme Corporation ELIGLUSTAT 84 mg/1 Glucosylceramide Synthase Inhibitor [EPC],Glucosylceramide Synthase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 58468-0357_d986d7b0-b2f5-48d7-af39-f01669bc674f 58468-0357 HUMAN PRESCRIPTION DRUG Campath ALEMTUZUMAB INJECTION INTRAVENOUS 20091130 BLA BLA103948 Genzyme Corporation ALEMTUZUMAB 30 mg/mL CD52-directed Antibody Interactions [MoA],CD52-directed Cytolytic Antibody [EPC] N 20181231 58468-1025_4e992833-70ee-4307-9d51-5a351ed92e9d 58468-1025 CELLULAR THERAPY Carticel autologous cultured chondrocytes IMPLANT INTRA-ARTICULAR 19970822 BLA BLA103661 Genzyme Corporation AUTOLOGOUS CULTURED CHONDROCYTES 12000000 1/1 Autologous Cultured Cell [EPC],Cells, Cultured, Autologous [Chemical/Ingredient],Chondrocytes [Chemical/Ingredient] N 20181231 58468-1849_b0abb052-43c3-4127-a87a-efe2a77bcb36 58468-1849 HUMAN PRESCRIPTION DRUG Thyrogen THYROTROPIN ALFA KIT 19981130 NDA NDA020898 Genzyme Corporation N 20181231 58468-1983_50ade44e-9936-4fdb-b58c-f1ce6e4db53c 58468-1983 HUMAN PRESCRIPTION DRUG Cerezyme IMIGLUCERASE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19940523 NDA NDA020367 Genzyme Corporation IMIGLUCERASE 40 U/mL Glucosylceramidase [Chemical/Ingredient],Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC] N 20181231 58468-4663_50ade44e-9936-4fdb-b58c-f1ce6e4db53c 58468-4663 HUMAN PRESCRIPTION DRUG Cerezyme IMIGLUCERASE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19940523 NDA NDA020367 Genzyme Corporation IMIGLUCERASE 40 U/mL Glucosylceramidase [Chemical/Ingredient],Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC] N 20181231 58468-7820_5da353d0-df87-4359-a92b-df8811769e55 58468-7820 HUMAN PRESCRIPTION DRUG CAPRELSA Vandetanib TABLET ORAL 20110725 NDA NDA022405 Genzyme Corporation VANDETANIB 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 58468-7840_5da353d0-df87-4359-a92b-df8811769e55 58468-7840 HUMAN PRESCRIPTION DRUG CAPRELSA Vandetanib TABLET ORAL 20110725 NDA NDA022405 Genzyme Corporation VANDETANIB 300 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 58469-0100_a49be039-5eb4-48bd-8812-cd7f85f6548d 58469-0100 HUMAN OTC DRUG Perfect Finish SPF-30 Zinc Oxide LOTION TOPICAL 20140120 OTC MONOGRAPH FINAL part352 Jenelt Cosmetics ZINC OXIDE 20 g/100mL E 20171231 58469-6100_244b582b-350a-382e-e054-00144ff8d46c 58469-6100 HUMAN OTC DRUG Ultra UV Defense SPF 30 Zinc Oxide CREAM TOPICAL 20140326 OTC MONOGRAPH FINAL part352 Jenelt Cosmetics ZINC OXIDE .135 mg/g E 20171231 58474-010_b833d43f-8157-4dac-b1a1-7df839da87f2 58474-010 HUMAN OTC DRUG PURE HYDROGEL MASK PACK Glycerin PATCH TOPICAL 20130301 OTC MONOGRAPH FINAL part347 WOOIL C&TECH.CORP GLYCERIN 7.5 g/30g N 20181231 58474-020_7ea58976-00d5-4005-9f8e-676a2c65c869 58474-020 HUMAN OTC DRUG PURE HYDROGEL APPLE ZONE Glycerin PATCH TOPICAL 20130301 OTC MONOGRAPH FINAL part347 WOOIL C&TECH.CORP GLYCERIN 7.5 g/30g N 20181231 58479-013_43a2b971-a798-55a7-e054-00144ff8d46c 58479-013 HUMAN OTC DRUG goddess garden ORGANICS Baby NATURAL SUNSCREEN SPF 30 ZINC OXIDE CREAM TOPICAL 20150115 20180630 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden ZINC OXIDE 190 mg/mL E 20171231 58479-014_43a31694-a4fd-6479-e054-00144ff8d46c 58479-014 HUMAN OTC DRUG goddess garden ORGANICS Everyday NATURAL SUNSCREEN SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150116 20180531 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL E 20171231 58479-016_43a31694-a51d-6479-e054-00144ff8d46c 58479-016 HUMAN OTC DRUG goddess garden ORGANICS Kids NATURAL SUNSCREEN SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150116 20180531 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL E 20171231 58479-017_43a31694-a52d-6479-e054-00144ff8d46c 58479-017 HUMAN OTC DRUG goddess garden ORGANICS Kids Sport NATURAL SUNSCREEN SPF 30 TITANIUM DIOXIDE, ZINC OXIDE SPRAY TOPICAL 20150116 20180630 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL E 20171231 58479-018_43a31694-a53d-6479-e054-00144ff8d46c 58479-018 HUMAN OTC DRUG goddess garden ORGANICS Kids Sport NATURAL SUNSCREEN SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150117 20180228 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL E 20171231 58479-019_43a2d8fb-1ac0-5a7c-e054-00144ff8d46c 58479-019 HUMAN OTC DRUG goddess garden ORGANICS Sport NATURAL SUNSCREEN SPF 30 TITANIUM DIOXIDE, ZINC OXIDE SPRAY TOPICAL 20150117 20180630 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL E 20171231 58479-020_43a2d8fb-1ad0-5a7c-e054-00144ff8d46c 58479-020 HUMAN OTC DRUG goddess garden ORGANICS Sport NATURAL SUNSCREEN SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150117 20180228 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/mL; mg/mL E 20171231 58479-023_43b5d898-ff44-5c8e-e054-00144ff88e88 58479-023 HUMAN OTC DRUG Goddess Garden Organics Everyday Natural Sunscreen Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE SPRAY TOPICAL 20160116 20180731 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 64; 60 mg/g; mg/g E 20171231 58479-031_3eb1f90b-edc8-02d7-e054-00144ff88e88 58479-031 HUMAN OTC DRUG Facial Natural Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE LOTION TOPICAL 20160116 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures LLC dba Goddess Garden ZINC OXIDE 19 g/100g N 20181231 58479-032_3eb257fc-d4d6-5cb5-e054-00144ff8d46c 58479-032 HUMAN OTC DRUG Kids Natural Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE SPRAY TOPICAL 20160117 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 6.4; 6 g/100g; g/100g N 20181231 58479-033_3e4deb64-8baf-490f-e054-00144ff88e88 58479-033 HUMAN OTC DRUG Baby Natural Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE LOTION TOPICAL 20160115 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures LLC dba Goddess Garden ZINC OXIDE 19 g/100g N 20181231 58479-034_3eb257fc-d4e6-5cb5-e054-00144ff8d46c 58479-034 HUMAN OTC DRUG Kids Sport Natural Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20160117 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 6.4; 6 g/100g; g/100g N 20181231 58479-035_42a0cb99-91b2-4c34-e054-00144ff8d46c 58479-035 HUMAN OTC DRUG Sport Natural Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE AEROSOL, SPRAY TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 6.4; 6 g/100g; g/100g N 20181231 58479-036_42a27a8a-2090-20d0-e054-00144ff8d46c 58479-036 HUMAN OTC DRUG Everyday Natural Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20160116 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 6.4; 6 g/100g; g/100g N 20181231 58479-037_42a0cb99-91c4-4c34-e054-00144ff8d46c 58479-037 HUMAN OTC DRUG Kids Sport Natural Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE AEROSOL, SPRAY TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 6.4; 6 g/100g; g/100g N 20181231 58479-038_42a2192b-106e-0f9d-e054-00144ff8d46c 58479-038 HUMAN OTC DRUG Kids Natural Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20160116 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 6.4; 6 g/100g; g/100g N 20181231 58479-040_3eb257fc-d4f7-5cb5-e054-00144ff8d46c 58479-040 HUMAN OTC DRUG Sport Natural Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 6.4; 6 g/100g; g/100g N 20181231 58479-042_437de76e-83a4-5016-e054-00144ff88e88 58479-042 HUMAN OTC DRUG Goddess Garden Organics Kids Natural Sunscreen SPF 30 TITANIUM DIOXIDE, ZINC OXIDE AEROSOL, SPRAY TOPICAL 20160117 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 6.4; 6 g/100g; g/100g N 20181231 58479-043_437de76e-83a4-5016-e054-00144ff88e88 58479-043 HUMAN OTC DRUG Goddess Garden Organics Kids Natural Sunscreen SPF 30 TITANIUM DIOXIDE, ZINC OXIDE SPRAY TOPICAL 20160117 OTC MONOGRAPH NOT FINAL part352 Crossing Cultures, LLC dba Goddess Garden TITANIUM DIOXIDE; ZINC OXIDE 6.4; 6 g/100g; g/100g N 20181231 58481-000_660a6fc7-44c5-45f6-b11b-9e9cee3884dc 58481-000 HUMAN OTC DRUG SESSION SAVERS SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130624 OTC MONOGRAPH NOT FINAL part352 Session Savers Sunscreen LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58484-100_e912b891-a457-4224-8a5b-7b7cb2b9a268 58484-100 HUMAN OTC DRUG Mr Dudleys Topical Pain Relief Menthol CREAM TOPICAL 20130513 OTC MONOGRAPH NOT FINAL part348 DUDLEY WELLNESS COMPANY INC MENTHOL 2.5 g/100g E 20171231 58484-200_2b2b2e5d-ad74-4d36-ac5a-615a027bc5cc 58484-200 HUMAN OTC DRUG Mr Dudleys Topical Cycle Relief with Nutmeg Menthol CREAM TOPICAL 20131024 OTC MONOGRAPH NOT FINAL part348 Dudley Wellness Company Inc MENTHOL 2.5 g/100g E 20171231 58487-001_6461fd18-6b4d-809a-73f4-fd0c23a99291 58487-001 HUMAN PRESCRIPTION DRUG DURLAZA Acetylsalicylic Acid CAPSULE, EXTENDED RELEASE ORAL 20150925 NDA NDA200671 New Haven Pharmaceuticals, Inc. ASPIRIN 162.5 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE] E 20171231 58488-001_32e2dc5a-de5d-6b96-e054-00144ff88e88 58488-001 HUMAN OTC DRUG Benzalkonium Chloride Antiseptic benzalkonium chloride SWAB TOPICAL 20130520 OTC MONOGRAPH NOT FINAL part333A Tongzhou Ruihong Medical Products Factory BENZALKONIUM CHLORIDE .0013 mg/1 E 20171231 58488-002_33523ba4-3c5e-4a11-e054-00144ff88e88 58488-002 HUMAN OTC DRUG STING RELIEF MEDICATED PAD Benzocaine SWAB TOPICAL 20130520 OTC MONOGRAPH FINAL part333B Tongzhou Ruihong Medical Products Factory BENZOCAINE .06 mg/1 E 20171231 58488-003_33523ba4-3c6b-4a11-e054-00144ff88e88 58488-003 HUMAN OTC DRUG Povidone-Iodine Prep Pad Povidone-Iodine SWAB PERCUTANEOUS 20130520 OTC MONOGRAPH FINAL part333C Tongzhou Ruihong Medical Products Factory POVIDONE-IODINE 10 mg/1 E 20171231 58488-004_33523ba4-3c79-4a11-e054-00144ff88e88 58488-004 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20130520 OTC MONOGRAPH NOT FINAL part333A Tongzhou Ruihong Medical Products Factory ISOPROPYL ALCOHOL .7 mL/1 E 20171231 58488-005_33523ba4-3c87-4a11-e054-00144ff88e88 58488-005 HUMAN OTC DRUG Cleansing Towelette benzalkonium chloride SWAB TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333A Tongzhou Ruihong Medical Products Factory BENZALKONIUM CHLORIDE .13 mg/1 E 20171231 58488-006_9ef84712-e6fc-4a27-b9d8-b4e926b8256e 58488-006 HUMAN OTC DRUG Povidone-Iodine Solution Povidone-Iodine SOLUTION PERCUTANEOUS 20140520 OTC MONOGRAPH FINAL part333C Tongzhou Ruihong Medical Products Factory POVIDONE-IODINE .01 mg/g E 20171231 58494-001_630d9a3b-39f9-5c6e-e053-2991aa0a61bc 58494-001 HUMAN OTC DRUG Face Stockholm BB Natural Beauty Balm SPF 30 Shade NR 1 OCTINOXATE, TITANIUM DIOXIDE, ZINC DIOXIDE CREAM TOPICAL 20160725 20180801 OTC MONOGRAPH NOT FINAL part352 Face Stockholm OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 20; 128; 49 mg/mL; mg/mL; mg/mL N 20191231 58494-002_630df94d-78d7-2b4b-e053-2991aa0aae04 58494-002 HUMAN OTC DRUG Face Stockholm BB Natural Beauty Balm SPF 30 Shade NR 2 OCTINOXATE, TITANIUM DIOXIDE, ZINC DIOXIDE CREAM TOPICAL 20160725 20190401 OTC MONOGRAPH NOT FINAL part352 Face Stockholm OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 20; 128; 49 mg/mL; mg/mL; mg/mL N 20191231 58503-005_9a845e13-c296-4b88-9be4-d271dc5f81b8 58503-005 HUMAN OTC DRUG Hand Sanitizer with Moisturizers Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 147 mL/237mL N 20181231 58503-006_2af683f1-8bb5-446f-8238-c4a253f43ff7 58503-006 HUMAN OTC DRUG Hand Sanitizer with Moisturizers Vitamin E and Aloe Ethyl Alcohol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 147 mL/237mL N 20181231 58503-007_1e8a6da6-bd29-4ce0-8054-875f94dd4dcb 58503-007 HUMAN OTC DRUG Ice Cold Topical Analgesic Gel Menthol GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part348 China Ningbo Shangge Cosmetic Technology Corp. MENTHOL 2.84 mg/227mg N 20181231 58503-008_51566386-0205-44cc-9562-59629e75951b 58503-008 HUMAN OTC DRUG Hand Cleanse Refill Triclosan GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 7.5 mg/500mg N 20181231 58503-009_3156b981-0261-4753-93ff-19e966d26c65 58503-009 HUMAN OTC DRUG Hand Cleanse Triclosan GEL TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 7.5 mg/500mg N 20181231 58503-012_8c5a97d5-7776-4dc6-b726-a2c0e4b0efd4 58503-012 HUMAN OTC DRUG Instant Hand Sanitizer Aloe Vera Ethyl Alcohol GEL TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 146 mL/236mL N 20181231 58503-013_79cf4c1d-076c-42a6-9ea5-d63132d2c09a 58503-013 HUMAN OTC DRUG Instant Hand Sanitizer - Ice Clear Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 37 mL/60mL N 20181231 58503-014_0c487774-e999-4991-9eb8-2ab1aa456eaf 58503-014 HUMAN OTC DRUG Instant Hand Sanitizer - Clear Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 147 mL/237mL N 20181231 58503-015_8f397343-492b-40f9-8cee-a0624f10eb40 58503-015 HUMAN OTC DRUG Instant Hand Sanitizer - Cocoa Butter Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 147 mL/237mL N 20181231 58503-016_2164da49-7fa0-4c7c-9b52-d3ecd74e20ef 58503-016 HUMAN OTC DRUG Liquid Hand Cleanse Triclosan GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 10 mg/500mg N 20181231 58503-017_654a9d26-02fb-43b7-b587-e120391fc370 58503-017 HUMAN OTC DRUG Instant Hand Sanitizer - Original Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 33 mL/53mL N 20181231 58503-018_b82e2808-963b-4699-b2b9-232c8d2718f2 58503-018 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 6 mL/10mL N 20181231 58503-019_cdfdaa56-6396-4e63-97f3-057301b82ee7 58503-019 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Fresh Citrus Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 3.3 mg/221mL N 20181231 58503-020_9e19996c-f78a-4e55-873e-3c0d0f3ab389 58503-020 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Mountain Spring Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 3.3 mg/221mL N 20181231 58503-021_b1bc20ff-e574-4ea7-97af-7e1a88e214cb 58503-021 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Original Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 3.3 mg/221mL N 20181231 58503-022_0fce83f9-452d-42e6-b4b1-917edd6452e7 58503-022 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Original Triclosan SOAP TOPICAL 20130903 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 6.6 1/443mL N 20181231 58503-023_4a73639f-41d4-4377-b728-33f3de37da86 58503-023 HUMAN OTC DRUG XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate Triclosan SOAP TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 3.3 mg/221mL N 20181231 58503-024_e399908f-2858-4103-9f47-45023c3d1a8b 58503-024 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse Cocoa and Shea Butter PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 20 mg/400mg N 20181231 58503-025_7a2e7d33-7601-43de-90c6-5a5102d9e470 58503-025 HUMAN OTC DRUG XtraCare Anti-Dandruff Conditioner Coconut and Shea Butter PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 20 mg/400mg N 20181231 58503-026_b181d3be-f6e2-430f-8417-ff71c3451244 58503-026 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptus PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 20 mg/400mg N 20181231 58503-027_1d84d629-5310-437b-8148-43e529f4c36d 58503-027 HUMAN OTC DRUG XtraCare Anti-Dandruff Conditioner mint and eucalyptus PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 20 mg/400mg N 20181231 58503-028_08d0b7c5-e198-4252-b711-ca25fbf3e816 58503-028 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse for normal hair PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 20 mg/400mg N 20181231 58503-029_f84a96eb-1f77-4db4-8ad7-eef08c9822bf 58503-029 HUMAN OTC DRUG XtraCare Anti-Dandruff Hair Cleanse for sensitive hair PYRITHIONE ZINC SHAMPOO TOPICAL 20131009 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 20 mg/400mg N 20181231 58503-030_c356c30e-4f24-4d38-97e0-42215f600d22 58503-030 HUMAN OTC DRUG Acne Body Wash Salicylic Acid GEL TOPICAL 20131118 OTC MONOGRAPH FINAL part333D China Ningbo Shangge Cosmetic Technology Corp. SALICYLIC ACID 7 mg/354mg N 20181231 58503-031_cc33e442-6ffb-41e6-b7be-7f7e1670b3db 58503-031 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Salicylic Acid GEL TOPICAL 20131118 OTC MONOGRAPH FINAL part333D China Ningbo Shangge Cosmetic Technology Corp, SALICYLIC ACID 3 g/150g N 20181231 58503-032_10a10256-c219-448b-9cbe-195ef980b2ff 58503-032 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Tea Tree Oil Salicylic Acid GEL TOPICAL 20131120 OTC MONOGRAPH FINAL part333D China Ningbo Shangge Cosmetic Technology Corp. SALICYLIC ACID 3 g/150g N 20181231 58503-033_033ad923-de3b-44e1-a13f-7a7667fc49b1 58503-033 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Facial Cleanser Grapefruit Salicylic Acid GEL TOPICAL 20131121 OTC MONOGRAPH FINAL part333D China Ningbo Shangge Cosmetic Technology Corp. SALICYLIC ACID 4 mg/177mg N 20181231 58503-034_4636591a-8a1e-46d4-b6c6-ecd58aa8349b 58503-034 HUMAN OTC DRUG Oil-Free Foaming Acne Wash Facial Cleanser Tea Tree Oil Salicylic Acid GEL TOPICAL 20131121 OTC MONOGRAPH FINAL part333D China Ningbo Shangge Cosmetic Technology Corp. SALICYLIC ACID 4 mg/177mg N 20181231 58503-036_01d43cbc-c9ef-4ed9-bba0-217bc0b34e32 58503-036 HUMAN OTC DRUG XtraCare Foaming Facial Cleanser Triclosan GEL TOPICAL 20131126 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN 1 mg/237mg N 20181231 58503-037_8ad50949-ea26-4952-94ab-ce0d11483c26 58503-037 HUMAN OTC DRUG XtraCare Skin Relief Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp. DIMETHICONE 5 mg/354mg N 20181231 58503-038_6669ea40-565f-4bb6-babd-3cd28d2de0be 58503-038 HUMAN OTC DRUG XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp. DIMETHICONE 5 mg/354mg N 20181231 58503-039_4ad70d1d-4125-4e3e-bba1-038f6e11099f 58503-039 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Cocoa Butter Enriched Petroleum CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp. PETROLATUM 59 g/198g N 20181231 58503-040_a289768b-3a13-43d1-b6c3-1d7f69e0818a 58503-040 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Vitamin E enriched Petrolatum CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp PETROLATUM 59 g/198g N 20181231 58503-041_709ccbe3-7379-4524-bcc5-3df74b631364 58503-041 HUMAN OTC DRUG XtraCare Dry Fresh Invisible Solid Aluminum Chlorohydrate CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part350 China Ningbo Shangge Cosmetic Technology Corp. ALUMINUM CHLOROHYDRATE 11 g/57g N 20181231 58503-042_204eee9f-577c-4f4f-a5ad-f99e67c77bd1 58503-042 HUMAN OTC DRUG XtraCare Invisible Solid Lady Stick Powder Fresh Aluminum Chlorohydrate CREAM TOPICAL 20140124 OTC MONOGRAPH FINAL part350 China Ningbo Shangge Cosmetic Technology Corp. ALUMINUM CHLOROHYDRATE 11 g/57g N 20181231 58503-043_805e382b-d193-4a06-bb93-91fcd9cc947f 58503-043 HUMAN OTC DRUG XtraCare Hand Sanitizer Moisturize with Vitamin E Ethyl Alcohol GEL TOPICAL 20140124 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp ALCOHOL 146 g/236g N 20181231 58503-044_466186bb-badf-4f5b-b679-bdf64d0b4988 58503-044 HUMAN OTC DRUG XtraCare Hand Sanitizer Moisurize with Vitamin E and Aloe Ethyl Alcohol GEL TOPICAL 20140124 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp ALCOHOL 146 g/236g N 20181231 58503-045_2e6b0a1b-c1fa-4680-8fca-b00d95c0954e 58503-045 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower Benzalkonium Chloride LIQUID TOPICAL 20140124 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp BENZALKONIUM CHLORIDE .5 g/444g N 20181231 58503-046_9dafa31b-f982-492c-bf4c-b2b330136034 58503-046 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast Benzalkonium Chloride SOAP TOPICAL 20140128 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp. BENZALKONIUM CHLORIDE .5 g/444g N 20181231 58503-047_b0b1bca9-95f2-45b4-ae0f-7b6bdc782347 58503-047 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp, BENZALKONIUM CHLORIDE .2 g/221g N 20181231 58503-048_cd9699ae-5087-4da2-8f5c-6303848b2be7 58503-048 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Wild Berry Blast Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp BENZALKONIUM CHLORIDE .2 g/221g N 20181231 58503-049_34aaf9ec-69f0-49a9-a300-987a6dbfea7d 58503-049 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp. BENZALKONIUM CHLORIDE .2 g/221g N 20181231 58503-050_66d5a935-a9ef-4bca-91f1-f7a73d447154 58503-050 HUMAN OTC DRUG XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom Benzalkonium Chloride SOAP TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A China Ningbo Shangge Cosmetic Technology Corp. BENZALKONIUM CHLORIDE .5 g/444g N 20181231 58503-051_c50914e0-6ede-47c2-a522-92fb3ddd2ed4 58503-051 HUMAN OTC DRUG XtraCare Vaporizing Chest Rub Camphor, Menthol GEL TOPICAL 20140130 OTC MONOGRAPH FINAL part341 China Ningbo Shangge Cosmetic Technology Corp. CAMPHOR (NATURAL); MENTHOL 5; 1 g/113g; g/113g N 20181231 58503-052_11c0101a-919d-41cc-b759-be3fc358a00f 58503-052 HUMAN OTC DRUG XtraCare Ice Cold Topical Analgesic Gel Menthol GEL TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part348 China Ningbo Shangge Cosmetic Technology Corp MENTHOL 3 g/227g N 20181231 58503-053_6bd8be29-7da4-46f1-b051-7b18c73a74d3 58503-053 HUMAN OTC DRUG XtraCare Dandruff Hair Wash Salicylic Acid SHAMPOO TOPICAL 20140205 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. SALICYLIC ACID 10 g/325g N 20181231 58503-054_35307038-2556-4c80-ae62-89279b6636bd 58503-054 HUMAN OTC DRUG XtraCare Skin Relief Oatmeal Daily Moisturizing Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp. DIMETHICONE 3 g/227g N 20181231 58503-055_99e4bae5-f58a-4b92-8608-dd7685368d45 58503-055 HUMAN OTC DRUG XtraCare with cooling action Oatmeal Skin Relief Calmin Dimethicone LOTION TOPICAL 20131126 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp. DIMETHICONE 3 g/227g N 20181231 58503-057_b374d394-31c9-4787-8ccf-794f06b24715 58503-057 HUMAN OTC DRUG XtraCare Foaming Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp BENZALKONIUM CHLORIDE 3 g/207g N 20181231 58503-058_3f446e4c-a8da-46bd-b1b0-880ed0869bfa 58503-058 HUMAN OTC DRUG XtraCare Instant Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp ALCOHOL 37 g/60g N 20181231 58503-059_4123fca9-f2b2-4b5e-8daa-d53b9fcdf7b4 58503-059 HUMAN OTC DRUG XtraCare Instant Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp ALCOHOL 37 g/60g N 20181231 58503-060_0d13ae94-09c2-49ed-ac1b-cdcb44957062 58503-060 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Petrolatum JELLY TOPICAL 20140218 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp PETROLATUM 38 g/127g N 20181231 58503-061_065d5b9d-394f-4226-8201-e116a05cd181 58503-061 HUMAN OTC DRUG XtraCare Creamy Petroleum Jelly Petrolatum JELLY TOPICAL 20140218 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp PETROLATUM 38 g/127g N 20181231 58503-062_81f5a20b-dc4d-44e0-84b5-a5d9b3643493 58503-062 HUMAN OTC DRUG XtraCare Wet Wipes Benzethonium Chloride SWAB TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp BENZETHONIUM CHLORIDE 3 mg/100mg N 20181231 58503-063_87a77252-333a-4bb4-9938-b177935674d1 58503-063 HUMAN OTC DRUG Creamy Petroleum Jelly Petrolatum JELLY TOPICAL 20140819 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp. PETROLATUM 30 g/100g N 20181231 58503-064_f5a1b140-8724-48f6-b8a7-e6750fdaad9e 58503-064 HUMAN OTC DRUG XtraCare 2 in 1 Hair Cleanse and Condition Coconut Water Pyrithione Zinc SHAMPOO TOPICAL 20140827 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 2 g/100g N 20181231 58503-065_386c807c-8de1-42e2-b843-bb6a2bb1ad45 58503-065 HUMAN OTC DRUG XtraCare 2 in 1 Hair Cleanse and Condition Green Apple Pyrithione Zinc SHAMPOO TOPICAL 20140827 OTC MONOGRAPH FINAL part358H China Ningbo Shangge Cosmetic Technology Corp. PYRITHIONE ZINC 2 g/100g N 20181231 58503-066_aaf901be-f1c3-4109-a1e7-511589af1483 58503-066 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp BENZETHONIUM CHLORIDE .3 g/1 N 20181231 58503-067_ffd86e98-ea02-4963-ab07-8dbaa89ac03c 58503-067 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp BENZETHONIUM CHLORIDE .3 g/1 N 20181231 58503-068_58bb9347-c56e-414a-b446-e57de22063a6 58503-068 HUMAN OTC DRUG Wet Wipes benzethonium chloride CLOTH TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp BENZETHONIUM CHLORIDE .3 g/1 N 20181231 58503-070_dc0fd53b-cf46-4b2a-a294-b95ea4f4d914 58503-070 HUMAN OTC DRUG Baby XtraCare Oatmeal Dimethicone LOTION TOPICAL 20150216 OTC MONOGRAPH FINAL part347 China Ningbo Shangge Cosmetic Technology Corp DIMETHICONE 1.2 g/100g N 20181231 58503-071_e51b71d2-b3b3-4ec9-a0ad-e2b156e9b2e0 58503-071 HUMAN OTC DRUG XtraCare Cucumber Melon ethyl alcohol GEL TOPICAL 20150217 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp ALCOHOL 62 g/100g N 20181231 58503-072_de09ee21-acdd-40af-ab46-b9ab640746be 58503-072 HUMAN OTC DRUG XtraCare Lavender Chamomile ethyl alcohol GEL TOPICAL 20150217 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp ALCOHOL 62 g/100g N 20181231 58503-073_31a43322-021c-4d5d-a383-922ecf13190d 58503-073 HUMAN OTC DRUG XtraCare Sweet Pea Blossom ethyl alcohol GEL TOPICAL 20150217 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp ALCOHOL 62 g/100g N 20181231 58503-074_9dd97f02-7fc2-4019-98b3-216656154499 58503-074 HUMAN OTC DRUG XtraCare Warm Vanilla ethyl alcohol GEL TOPICAL 20150217 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp ALCOHOL 62 g/100g N 20181231 58503-075_b310921d-71b4-44d0-b692-b72dd42cc836 58503-075 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 62 mL/100mL N 20181231 58503-076_fe09b31a-2cb9-44f0-ac5e-7547d9ade28b 58503-076 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 62 mL/100mL N 20181231 58503-077_d4cb6695-df6a-49e6-a20e-87aa06e2f392 58503-077 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 62 mL/100mL N 20181231 58503-078_5913fa0a-3186-451b-8cae-f604fcb5b2fe 58503-078 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 62 mL/100mL N 20181231 58503-079_73b050c9-d6b5-4a60-b522-ffbf5cf991bb 58503-079 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 62 mL/100mL N 20181231 58503-080_91ce9bf9-6b63-4706-ad6a-3eb500116cc5 58503-080 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150603 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 62 mL/100mL N 20181231 58503-081_c9362608-e5c9-4937-8f47-ae763954949f 58503-081 HUMAN OTC DRUG Assured Aloe Ethyl Alcohol GEL TOPICAL 20150702 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 62 g/100g N 20181231 58503-082_2437cad8-1a0c-4797-b927-c832f616a481 58503-082 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20150702 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 62 g/100g N 20181231 58503-083_9ff13ec8-5b43-4093-8064-bcd141e89a36 58503-083 HUMAN OTC DRUG Antibacterial Hand Cleanse triclosan SOAP TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN .15 g/100g E 20171231 58503-084_4abb3ce0-ea45-4d61-b064-b0b9d1da3bf7 58503-084 HUMAN OTC DRUG Hand Cleanse Citrus Blast Scent triclosan SOAP TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN .2 g/100g E 20171231 58503-085_10ed8314-7120-429e-937b-47998bd0dbf5 58503-085 HUMAN OTC DRUG Hand Cleanse Water Melon Scent triclosan SOAP TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN .2 g/100g E 20171231 58503-086_3c59ae81-ed60-4cd7-b0e1-02deec2a217d 58503-086 HUMAN OTC DRUG Hand Cleanse Fresh Peach Scent triclosan SOAP TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. TRICLOSAN .2 g/100g E 20171231 58503-087_e57a41f8-4c7f-42c4-a909-dd2681dfe660 58503-087 HUMAN OTC DRUG Ice Cold Analgesic menthol GEL TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part348 China Ningbo Shangge Cosmetic Technology Corp. MENTHOL 1 g/100g E 20171231 58503-088_38cda13e-0fb7-4a68-e054-00144ff88e88 58503-088 HUMAN OTC DRUG Acne wash facial cleanser pink grapefruit Salicylic Acid LIQUID TOPICAL 20160729 OTC MONOGRAPH FINAL part333D China Ningbo Shangge Cosmetic Technology Corp. SALICYLIC ACID 2 g/200mL N 20181231 58503-089_38cd8649-767e-0e72-e054-00144ff8d46c 58503-089 HUMAN OTC DRUG Acne wash facial cleanser Tea tree oil Salicylic Acid LIQUID TOPICAL 20160729 OTC MONOGRAPH FINAL part333D China Ningbo Shangge Cosmetic Technology Corp. SALICYLIC ACID 2 g/200mL N 20181231 58503-090_4d76e83b-ceec-2efb-e054-00144ff8d46c 58503-090 HUMAN OTC DRUG XtraCare Instand Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20170418 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 70 g/100mL N 20181231 58503-091_4db19cf4-afef-3b0d-e054-00144ff88e88 58503-091 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 70 mL/100mL N 20181231 58503-092_4db1ade6-b794-0024-e054-00144ff8d46c 58503-092 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 70 mL/100mL N 20181231 58503-093_4db1e5ec-a61d-2b93-e054-00144ff8d46c 58503-093 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 70 mL/100mL N 20181231 58503-094_4db1d1dc-a416-3842-e054-00144ff88e88 58503-094 HUMAN OTC DRUG Assured Instant Ethyl Alcohol GEL TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 70 mL/100mL N 20181231 58503-095_4db19cf4-aff1-3b0d-e054-00144ff88e88 58503-095 HUMAN OTC DRUG Assured Aloe Ethyl Alcohol GEL TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 70 mL/100mL N 20181231 58503-096_4db2b318-4ba1-50c3-e054-00144ff8d46c 58503-096 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20170421 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 62 mL/100mL N 20181231 58503-097_4e26bfb6-d629-7357-e054-00144ff8d46c 58503-097 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 62 mL/100mL N 20181231 58503-098_4e26bfb6-d62b-7357-e054-00144ff8d46c 58503-098 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 62 mL/100mL N 20181231 58503-099_4e12fe0d-3a6e-13b5-e054-00144ff88e88 58503-099 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20170421 OTC MONOGRAPH NOT FINAL part333E China Ningbo Shangge Cosmetic Technology Corp. ALCOHOL 70 mL/100mL N 20181231 58503-100_4e263b4d-cd4a-3a00-e054-00144ff88e88 58503-100 HUMAN OTC DRUG Triclosan Free Antibacterial Antibacterial Chloroxylenol LIQUID TOPICAL 20170425 UNAPPROVED DRUG OTHER China Ningbo Shangge Cosmetic Technology Corp. CHLOROXYLENOL .3 g/100mL N 20181231 58503-101_5152aed0-99a0-34e3-e054-00144ff8d46c 58503-101 HUMAN OTC DRUG Triclosan Free Antibacterial 7.5 oz original Antibacterial Chloroxylenol LIQUID TOPICAL 20170606 UNAPPROVED DRUG OTHER China Ningbo Shangge Cosmetic Technology Corp. CHLOROXYLENOL .3 g/100mL N 20181231 58503-102_5152aed0-99ab-34e3-e054-00144ff8d46c 58503-102 HUMAN OTC DRUG Triclosan Free Antibacterial 7.5 oz (Ocean) Antibacterial Chloroxylenol LIQUID TOPICAL 20170606 UNAPPROVED DRUG OTHER China Ningbo Shangge Cosmetic Technology Corp. CHLOROXYLENOL .3 g/100mL N 20181231 58503-103_5152d510-e9ba-3e14-e054-00144ff8d46c 58503-103 HUMAN OTC DRUG Triclosan Free Antibacterial 7.5 oz (Strawberry Pomegranate) Antibacterial Chloroxylenol LIQUID TOPICAL 20170606 UNAPPROVED DRUG OTHER China Ningbo Shangge Cosmetic Technology Corp. CHLOROXYLENOL .3 g/100mL N 20181231 58503-104_5152aed0-99b8-34e3-e054-00144ff8d46c 58503-104 HUMAN OTC DRUG Triclosan Free Antibacterial 7.5 oz (Fresh Citrus) Antibacterial Chloroxylenol LIQUID TOPICAL 20170606 UNAPPROVED DRUG OTHER China Ningbo Shangge Cosmetic Technology Corp. CHLOROXYLENOL .3 g/100mL N 20181231 58517-001_e8f80f38-13c2-4688-85d9-f99510e08d92 58517-001 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130825 ANDA ANDA090548 New Horizon Rx Group, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 58517-020_f7e2081e-f97e-449a-a5e2-768ffcb931b4 58517-020 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE ORAL 20131231 ANDA ANDA076048 New Horizon Rx Group, LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 58517-040_462c8531-be91-4189-8471-e796777087a0 58517-040 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20130825 ANDA ANDA090564 New Horizon Rx Group, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 58517-060_01e45240-dc37-486b-8451-2b5e5a12cfdd 58517-060 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20130825 ANDA ANDA078787 New Horizon Rx Group, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58517-080_e8799c4d-1d81-4e78-a29e-01b54c576d09 58517-080 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20130825 ANDA ANDA078218 New Horizon Rx Group, LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 58517-100_308c2e2e-f9ef-47e3-bacb-5e0f4fea5814 58517-100 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20130825 ANDA ANDA077534 New Horizon Rx Group, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 58517-120_57ff62d2-0f5d-4756-9d43-147efc7d6942 58517-120 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20130825 ANDA ANDA078477 New Horizon Rx Group, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 58517-140_c3e59ee7-b196-4088-8662-2f047c6e1216 58517-140 HUMAN PRESCRIPTION DRUG SULFAMETHOXAZOLE AND TRIMETHOPRIM double strength SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET ORAL 20130825 ANDA ANDA076899 New Horizon Rx Group, LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 58517-160_113e0540-bfcd-4d68-b128-c5cfc1ce938e 58517-160 HUMAN PRESCRIPTION DRUG paroxetine hydrochloride paroxetine hydrochloride TABLET ORAL 20130825 ANDA ANDA078902 New Horizon Rx Group, LLC PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 58517-200_17f863dd-1b47-4f2c-8893-fb06e09250ca 58517-200 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130813 ANDA ANDA090121 New Horizon Rx Group, LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 58517-220_a13d2414-c7fe-4202-9cb4-a78984cb1fba 58517-220 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET ORAL 20130825 ANDA ANDA090722 New Horizon Rx Group, LLC LEVOFLOXACIN 500 mg/1 E 20171231 58517-240_3457501e-f3b7-48df-a874-ab25db0a4797 58517-240 HUMAN PRESCRIPTION DRUG Losartan Potatssium Losartan Potatssium TABLET ORAL 20130825 ANDA ANDA078243 New Horizon Rx Group, LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 58517-260_5fb6a9a3-f4d5-4ad2-9457-4651aea4a82a 58517-260 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20130825 ANDA ANDA077927 New Horizon Rx Group, LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 58517-300_75e40f0f-246e-457d-a4f4-8984a620feef 58517-300 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20130825 ANDA ANDA078432 New Horizon Rx Group, LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 58517-320_982fdb28-f826-4203-81c6-958cb73083e9 58517-320 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET, FILM COATED ORAL 20130825 ANDA ANDA076704 New Horizon Rx Group, LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 58517-340_5cbda603-31ef-43b8-a650-015822a1e2aa 58517-340 HUMAN PRESCRIPTION DRUG BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET ORAL 20130825 ANDA ANDA074253 New Horizon Rx Group, LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 E 20171231 58517-360_f7a32c82-ba7f-4c77-b3b2-f080afee9c6e 58517-360 HUMAN PRESCRIPTION DRUG warfarin sodium warfarin sodium TABLET ORAL 20130825 ANDA ANDA040663 New Horizon Rx Group, LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 58517-380_4ed0bea5-7cc0-4c59-9517-6628c53a27b4 58517-380 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130825 ANDA ANDA076416 New Horizon Rx Group, LLC TIZANIDINE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 58517-400_fa87df49-449e-4062-be6e-6b85da718a1b 58517-400 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130825 ANDA ANDA078010 New Horizon Rx Group, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 58517-420_3488e3d7-1285-4002-b351-15f59623a2eb 58517-420 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM Delayed Release PANTOPRAZOLE SODIUM TABLET ORAL 20130825 ANDA ANDA077058 New Horizon Rx Group, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 58517-440_165688ef-8ccc-47c2-ae3e-4c6bf2dcb048 58517-440 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20130825 ANDA ANDA077068 New Horizon Rx Group, LLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 58518-010_04e26667-d23f-4fad-9fcb-04214015c78c 58518-010 HUMAN OTC DRUG ENVIRONMENTAL DEFENSE ZINC OXIDE CREAM TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part352 Avasol ZINC OXIDE 225 mg/100mL E 20171231 58518-020_a3bd6294-10df-4782-a64e-624abf171497 58518-020 HUMAN OTC DRUG SURFERS BARRIER ZINC OXIDE STICK TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part352 Avasol ZINC OXIDE 24.5 g/100g E 20171231 58543-1001_7dfe8436-37a1-4f35-929d-5ed6d692b1af 58543-1001 HUMAN OTC DRUG ENA Actimineral A CALCIUM LIQUID ORAL 20130628 UNAPPROVED DRUG OTHER Jinju Bio Food CALCIUM 803.8 mg/1000mL N 20181231 58544-001_3b4a56aa-5341-675b-e054-00144ff8d46c 58544-001 HUMAN OTC DRUG All Aglow Perfect Cushion Foundation Titanium Dioxide,Octyl methoxycinnamate,Octyl Salicylate,Octocrylene,Zinc Oxide LIQUID TOPICAL 20160825 OTC MONOGRAPH FINAL part352 Hankook Cosmetics Manufacturing Co., Ltd._eumseong Factory OCTOCRYLENE; ZINC OXIDE; OCTISALATE; OCTINOXATE; TITANIUM DIOXIDE 2; 2; 4.8; 7; 9 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 58544-101_75d4de95-e274-40a6-84d9-38db6d415787 58544-101 HUMAN OTC DRUG April Skin Magic Snow Cushion SPF50 PLUS (15g) (Pink Beige) Titanium Dioxide, Zinc Oxide, Octocrylene LOTION TOPICAL 20160711 OTC MONOGRAPH NOT FINAL part352 Hankook Cosmetics Manufacturing Co., Ltd TITANIUM DIOXIDE; ZINC OXIDE; OCTOCRYLENE .09; .02; .02 1/15g; 1/15g; 1/15g N 20181231 58544-102_f28e4b7f-5dd3-4f3b-9adf-fcec2a8abe6e 58544-102 HUMAN OTC DRUG April Skin Magic Snow Cushion SPF50 PLUS (15g) (Natural Beige) Titanium Dioxide, Zinc Oxide, Octocrylene LOTION TOPICAL 20160711 OTC MONOGRAPH NOT FINAL part352 Hankook Cosmetics Manufacturing Co., Ltd TITANIUM DIOXIDE; ZINC OXIDE; OCTOCRYLENE .09; .02; .02 1/15g; 1/15g; 1/15g N 20181231 58552-121_5529ff63-6458-4c4e-8145-74ad6b4666a8 58552-121 HUMAN OTC DRUG GILTUSS PEDIATRIC dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION/ DROPS ORAL 20091019 OTC MONOGRAPH FINAL part341 Gil Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 7.5; 88; 2.5 mg/mL; mg/mL; mg/mL N 20181231 58552-122_f8f87c2a-bf82-4211-9969-92f77a3389ca 58552-122 HUMAN OTC DRUG Giltuss Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride SYRUP ORAL 20091019 OTC MONOGRAPH FINAL part341 Gil Pharmaceutical Corp DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 28; 388; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 58552-127_d13554c2-8d41-43e5-80be-bf48d6dc0bce 58552-127 HUMAN OTC DRUG Carbaphen CH chlophedianol HCl, chlorpheniramine maleate, and phenylephrine SUSPENSION ORAL 20111229 OTC MONOGRAPH FINAL part341 Gil Pharmaceutical Corp CHLOPHEDIANOL HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 24; 4; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 58552-128_e01afa69-3911-4041-8256-71ac3e807a9c 58552-128 HUMAN OTC DRUG Carbaphen Ped CH Chlophedianol HCL, Chlorpheniramine Maleate and Phenylephrine HCl SUSPENSION ORAL 20120329 OTC MONOGRAPH FINAL part341 Gil Pharmaceutical Corp CHLOPHEDIANOL HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 8; 1.25; 2.5 mg/mL; mg/mL; mg/mL E 20171231 58552-313_cd8c6362-a8dc-4c3b-bee9-cfe31b29437c 58552-313 HUMAN OTC DRUG Gilphex TR Guaifenesin and Phenylephrine HCl TABLET ORAL 20080212 OTC MONOGRAPH FINAL part341 Gil Pharmaceutical Corp GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 388; 10 mg/1; mg/1 N 20181231 58552-317_683e0694-a1e5-49f9-ba36-bcd67917be00 58552-317 HUMAN OTC DRUG GILTUSS TOTAL RELEASE Guaifenesin, Dextromethorphan HBr, and Phenylephrine HCl TABLET ORAL 20091019 OTC MONOGRAPH FINAL part341 Gil Pharmaceutical Corp GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 388; 28; 10 mg/1; mg/1; mg/1 N 20181231 58554-0002_90c06bdc-5dc1-4555-88e4-fbc8fcc1c26a 58554-0002 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 19910101 UNAPPROVED MEDICAL GAS Memorial Home Care OXYGEN 210 mL/L E 20171231 58559-001_1f9feebc-001c-43cc-84ee-3587dc35c749 58559-001 HUMAN OTC DRUG Relief Pain Relieving Cream MENTHOL CREAM TOPICAL 20040522 OTC MONOGRAPH NOT FINAL part348 Corganics, LP MENTHOL 2.5 g/100g N 20181231 58559-002_c9fab101-d73f-47bd-8b37-869c40d81b07 58559-002 HUMAN OTC DRUG Relief Pain Relieving Cream MENTHOL CREAM TOPICAL 20040522 OTC MONOGRAPH NOT FINAL part348 Corganics, LP MENTHOL 3 g/100g N 20181231 58575-130_da7fdb9c-d76c-4af7-960d-88d88b5e4d5e 58575-130 HUMAN OTC DRUG DermaGel HAND SANITIZING ALCOHOL GEL TOPICAL 19900901 OTC MONOGRAPH NOT FINAL part333E Inopak. Ltd ALCOHOL 70 mL/100mL N 20181231 58575-150_eff99a7c-7bb0-4067-b967-b91ea14f1fd5 58575-150 HUMAN OTC DRUG SaniGuard-SF ALCOHOL LIQUID TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333E Inopak. Ltd ALCOHOL 70 mL/100mL N 20181231 58575-161_72e8f2e0-b66a-45ad-8fdd-8ce78126aa66 58575-161 HUMAN OTC DRUG ICS3 Blue Healthcare Hand Antiseptic ETHYL ALCOHOL LIQUID TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E Inopak, Ltd ALCOHOL 56.525 g/100mL N 20181231 58575-162_fa524da1-cfa1-4ef5-bd5b-5134858d4279 58575-162 HUMAN OTC DRUG ICS3 Pink Healthcare Antiseptic Hand BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part333A Inopak, Ltd BENZALKONIUM CHLORIDE 130 mg/100mL N 20181231 58575-170_b98d13e0-8f91-4595-b87b-67c42f58eba9 58575-170 HUMAN OTC DRUG AQUACIL BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333E Inopak, Ltd BENZALKONIUM CHLORIDE 100 mg/100mL N 20181231 58575-503_57168b76-05ec-44bf-8ae5-3a54c9004ff8 58575-503 HUMAN OTC DRUG INODERM Style PARACHLOROMETAXYLENOL LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part333E Inopak, Ltd CHLOROXYLENOL .003 mg/mL N 20181231 58575-506_1400eaaf-7569-4958-94f6-29eace46a153 58575-506 HUMAN OTC DRUG INOFOAM Antibacterial Foaming Hand PARACHLOROMETAXYLENOL LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part333E Inopak, Ltd CHLOROXYLENOL .003 mg/mL N 20181231 58578-0729_60b727c4-4553-0793-e053-2991aa0a1320 58578-0729 HUMAN OTC DRUG CloSYS Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20110315 OTC MONOGRAPH FINAL part355 Rowpar Pharmaceuticals, Inc. SODIUM FLUORIDE 1.1 mg/g N 20181231 58578-0749_5f87abb7-0e9e-6369-e053-2a91aa0a2411 58578-0749 HUMAN OTC DRUG CloSYS Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20171020 OTC MONOGRAPH FINAL part355 Rowpar Pharmaceuticals, Inc. SODIUM FLUORIDE 1.1 mg/g N 20181231 58578-1234_3c5cd3d1-36e9-43d5-8f6d-cece42609efd 58578-1234 HUMAN OTC DRUG CloSYS Fluoride Rinse Sodium Fluoride RINSE ORAL 20160218 OTC MONOGRAPH FINAL part355 Rowpar Pharmaceuticals, Inc. SODIUM FLUORIDE .05 g/100mL N 20191231 58590-001_f35d318a-f1af-48f2-ba8c-92bbd465c7c8 58590-001 HUMAN OTC DRUG Hand Armor Benzalkonium Chloride LIQUID TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part333E HyGenesis BENZALKONIUM CHLORIDE 1.3 mg/g N 20181231 58593-225_9e294b10-b439-4605-9e3b-4bbdc11a12c3 58593-225 HUMAN OTC DRUG Rompe Pecho SF FLU Dextromethorphan, Brompheniramine Maleate, Phenylephrine Hydrochloride LIQUID ORAL 20071001 OTC MONOGRAPH FINAL part341 Efficient Laboratories Inc DEXTROMETHORPHAN HYDROBROMIDE; BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 10; 10; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 58593-235_743e16f2-f43c-4669-a500-e2ccbad289dd 58593-235 HUMAN OTC DRUG Rompe Pecho CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL LIQUID ORAL 20071001 OTC MONOGRAPH FINAL part341 Efficient Laboratories Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 58593-255_cd0780bd-3de8-4037-b7ce-195150df8a87 58593-255 HUMAN OTC DRUG Cough Out Guaifenesin LIQUID ORAL 19970701 OTC MONOGRAPH FINAL part341 Efficient Laboratories Inc. GUAIFENESIN 100 mg/5mL N 20181231 58593-265_136c8dad-c517-40be-ba09-0a35d9d90acd 58593-265 HUMAN OTC DRUG Rompe Pecho SF Guaifenesin LIQUID ORAL 19990301 OTC MONOGRAPH FINAL part341 Efficient Laboratories, Inc. GUAIFENESIN 100 mg/5mL N 20181231 58593-275_780c527c-90e6-48c4-bb44-13f698220e87 58593-275 HUMAN OTC DRUG Rompe Pecho DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20011001 OTC MONOGRAPH FINAL part341 Efficient Laboratories Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 58593-285_b68ce0dd-01f4-4664-ae8c-fe235991675b 58593-285 HUMAN OTC DRUG Hongo Killer Tolnaftate AEROSOL, POWDER TOPICAL 20020301 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc TOLNAFTATE .1 g/10g N 20181231 58593-286_d0cc1fba-c0eb-45af-a6f5-3a2a1937ff97 58593-286 HUMAN OTC DRUG Hongo Killer Tolnaftate CREAM TOPICAL 20000101 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc TOLNAFTATE 10 mg/g N 20181231 58593-288_ebfb59c3-e804-4d9a-a4f7-0f7b4f55d677 58593-288 HUMAN OTC DRUG Hongo Killer Tolnaftate POWDER TOPICAL 20000101 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc TOLNAFTATE 1 g/100g N 20181231 58593-295_e7af9091-00e6-49e2-8658-df1987f25067 58593-295 HUMAN OTC DRUG Mielim y mas Dextromethorphan LIQUID ORAL 19970201 OTC MONOGRAPH FINAL part341 Efficient Laboratories Inc. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 58593-301_5ed69e5f-1d14-4fc0-9168-14b64a7d4403 58593-301 HUMAN OTC DRUG Hongo Killer Nail and Fungus Undecylenic Acid KIT 20160701 OTC MONOGRAPH FINAL part333c EFFICIENT LABORATORIES INC N 20181231 58593-600_987f5b6f-5b1a-4ffe-8316-f2e84c2bb982 58593-600 HUMAN OTC DRUG Hongo Killer Undecylenic Acid LIQUID TOPICAL 19910101 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc UNDECYLENIC ACID 1.1 mL/10mL N 20181231 58593-601_0ab36048-0d31-42be-b4a4-80f4cea7f0ae 58593-601 HUMAN OTC DRUG Hongo Killer undecylenic acid SPRAY TOPICAL 20130701 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc UNDECYLENIC ACID 2 mg/10mL N 20181231 58593-625_a483cdc5-6264-43f5-824d-f9d2f6e6ef14 58593-625 HUMAN OTC DRUG Hongo Killer Tolnaftate AEROSOL, SPRAY TOPICAL 20041001 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc MICONAZOLE NITRATE .2 g/10g N 20181231 58593-780_6962fae7-ff07-4bd7-bb9a-3d717002c56b 58593-780 HUMAN OTC DRUG Finafta Ethyl Alcohol, Salicylic Acid, Benzocaine LIQUID ORAL 19911001 OTC MONOGRAPH NOT FINAL part356 Efficient Laboratories Inc. ALCOHOL; SALICYLIC ACID; BENZOCAINE 60; 1; 5 mL/100mL; mg/100mL; mg/100mL N 20181231 58593-781_b5686d5b-ca50-4291-8d4e-b34e7db17753 58593-781 HUMAN OTC DRUG Finafta Baby Benzocaine LIQUID ORAL 20000101 OTC MONOGRAPH NOT FINAL part356 Efficient Laboratories Inc. BENZOCAINE 7.5 mg/100mg N 20191231 58593-782_496cfe79-1d03-4cde-a056-004d2eed1dfd 58593-782 HUMAN OTC DRUG Finafta MultiOral Benzocaine SPRAY ORAL 20040901 OTC MONOGRAPH NOT FINAL part356 Efficient Laboratories Inc. BENZOCAINE 7.5 mg/100mL N 20181231 58593-800_3d3a6ff2-112b-481f-bdd4-034930f539b3 58593-800 HUMAN OTC DRUG Ongo - Fin TOLNAFTATE LIQUID TOPICAL 20040201 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc. TOLNAFTATE 1 mL/100mL N 20181231 58593-825_20bd3beb-5f46-492c-9624-3e5222163ad2 58593-825 HUMAN OTC DRUG Hongo Killer Undecylenic Acid SOLUTION TOPICAL 19910101 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc UNDECYLENIC ACID 1.1 mL/10mL N 20181231 58593-826_49c28312-e23e-4206-b0d7-aa614dde9f96 58593-826 HUMAN OTC DRUG Hongo Killer Undecylenic Acid LIQUID TOPICAL 20120701 OTC MONOGRAPH FINAL part333C Efficient Laboratories Inc UNDECYLENIC ACID 25 mg/100mL N 20181231 58593-827_6b482c26-99fe-4ead-964a-987171a0159e 58593-827 HUMAN OTC DRUG Zero Allergy Cetirizine Hydrochloride TABLET ORAL 20130401 ANDA ANDA077498 Efficient Laboratories Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 58593-828_a0f3b42d-3bc5-4524-a61b-4fdc28005e4d 58593-828 HUMAN OTC DRUG Rompe Pecho Max Multi Symptoms Acetaminophen, Dextromethophan HBr, Phenylephrine HCl, Guaifenesin LIQUID ORAL 20140101 OTC MONOGRAPH FINAL part341 EFFICIENT LABORATORIES INC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 58593-829_49fa0ddc-460c-43cc-b3b6-87bc84ecedb6 58593-829 HUMAN OTC DRUG Rompe Pecho EX Guaifenesin LIQUID ORAL 20150101 OTC MONOGRAPH FINAL part341 Efficient Laboratories Inc GUAIFENESIN 100 mg/5mL N 20181231 58596-001_8c27e165-93f9-43f2-9ec3-9e9a5e644cff 58596-001 HUMAN OTC DRUG Cough and Cold XL3 Xtra Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140731 OTC MONOGRAPH FINAL part341 Selgel México, S.A. de C.V. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 250; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 58599-003_0c90365e-c06d-4368-b627-aac3c415ddd2 58599-003 HUMAN OTC DRUG DIPHENHYDRAMINE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20140731 OTC MONOGRAPH FINAL part341 PURINEPHARMA LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 58599-004_4924194e-5c66-4af3-b83a-5367a10248a2 58599-004 HUMAN OTC DRUG DIPHENHYDRAMINE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20140731 OTC MONOGRAPH FINAL part341 PURINEPHARMA LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 E 20171231 58599-008_5b36529b-628d-4eb6-858e-634e632a9787 58599-008 HUMAN OTC DRUG Phenol Sore Throat Spray SPRAY ORAL 20150301 OTC MONOGRAPH NOT FINAL part356 PURINEPHARMA LLC PHENOL 1.4 mg/mL E 20171231 58599-016_eeab3524-4ac0-4ca7-9ac4-a6d2450971f6 58599-016 HUMAN OTC DRUG MEDPURINE MEDPURINE TABLET ORAL 20150414 OTC MONOGRAPH FINAL part343 PURINEPHARMA LLC ASPIRIN 81 mg/1 N 20181231 58599-027_4dddfee7-1b3d-4b5f-9051-13aa25385922 58599-027 HUMAN OTC DRUG OXYMETAZOLINE HCl OXYMETAZOLINE HCl SPRAY ORAL 20150209 OTC MONOGRAPH FINAL part341 PURINEPHARMA LLC OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 58599-036_f3470af4-c278-48a4-9de9-2d6d974ab2eb 58599-036 HUMAN OTC DRUG SALINE NASAL SALINE NASAL SPRAY ORAL 20150207 OTC MONOGRAPH FINAL part349 PURINEPHARMA LLC SODIUM CHLORIDE 6.5 mg/mL E 20171231 58599-058_ceb5bd07-10c8-410b-accb-6aafa72bcb35 58599-058 HUMAN OTC DRUG Medibest Milk of Magnesia Magnesium Hydroxide LIQUID ORAL 20161012 OTC MONOGRAPH NOT FINAL part334 Purine Pharma LLC MAGNESIUM HYDROXIDE 1200 mg/15mL E 20171231 58602-022_305c12ff-a8df-44b6-935e-50c64fca21fe 58602-022 HUMAN OTC DRUG Aurodryl childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20150513 OTC MONOGRAPH FINAL part341 Aurohealth LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 58602-023_d581e5d4-2453-4cda-9f31-adb911979d5b 58602-023 HUMAN OTC DRUG Aurodryl Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20140910 OTC MONOGRAPH FINAL part341 Aurohealth LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 58602-024_3af10360-9b86-48ae-b09f-38b63cabfab2 58602-024 HUMAN OTC DRUG AuroZzil NIGHTTIME SLEEP-AID Diphenhydramine Hydrochloride SOLUTION ORAL 20150515 OTC MONOGRAPH FINAL part338 Aurohealth LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 58602-025_192e54f2-f19f-465f-b618-f62d6508339e 58602-025 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride SOLUTION ORAL 20141126 OTC MONOGRAPH FINAL part341 Aurohealth LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/10mL N 20181231 58602-026_d20697c2-bad1-4a2c-bc29-67ce28248e90 58602-026 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride SOLUTION ORAL 20141126 OTC MONOGRAPH FINAL part341 Aurohealth LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/20mL N 20181231 58602-027_bea08963-16c9-4c27-b0d6-5734b91a3900 58602-027 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride SOLUTION ORAL 20150801 OTC MONOGRAPH FINAL part341 Aurohealth LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/20mL N 20181231 58602-028_4de4f544-79cd-4a89-aafb-f2e2688b3c81 58602-028 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Allergy Cetirizine Hydrochloride SOLUTION ORAL 20150624 ANDA ANDA090750 Aurohealth LLC CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 58602-030_e000848a-8bbe-4149-bdcb-d7b4b0bd4d0d 58602-030 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Hives Relief Cetirizine Hydrochloride SOLUTION ORAL 20150624 ANDA ANDA090750 Aurohealth LLC CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 58602-106_61d84095-f296-43e4-9c92-242772f63f72 58602-106 HUMAN OTC DRUG AuroMucus - Childrens Cough Dextromethorphan Hydrobromide and Guaifenesin SOLUTION ORAL 20150824 OTC MONOGRAPH FINAL part341 Aurohealth LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 58602-107_34f2b315-5144-42c1-89b7-b8a55ef5ad84 58602-107 HUMAN OTC DRUG AuroMucus - Childrens Chest Congestion Guaifenesin SOLUTION ORAL 20150824 OTC MONOGRAPH FINAL part341 Aurohealth LLC GUAIFENESIN 100 mg/5mL N 20181231 58602-108_79ec8f43-b48f-437b-87a8-2b1ab1d978b0 58602-108 HUMAN OTC DRUG AuroMucus - Childrens Stuffy Nose and Cold Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20150519 OTC MONOGRAPH FINAL part341 Aurohealth LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 100; 2.5 mg/5mL; mg/5mL N 20181231 58602-110_ad8c993d-374c-4fb4-9e57-a4bdc0b7fe47 58602-110 HUMAN OTC DRUG AuroMucus - Fast Maximum Cold, Flu and Sore Throat Relief Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20150703 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 58602-111_d17aa5ec-ad0e-468e-809d-823132e319f3 58602-111 HUMAN OTC DRUG AuroMucus - Fast Maximum Cold and Sinus Acetaminophen, Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20150718 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 58602-112_3a88f8e2-2292-4f0b-b046-5c96a58be974 58602-112 HUMAN OTC DRUG AuroMucus - Fast Maximum Severe Congestion and Cough Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20150718 OTC MONOGRAPH FINAL part341 Aurohealth LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 58602-115_b95b6324-0fd2-4dac-b242-72bd13436d5b 58602-115 HUMAN OTC DRUG Aurotussin Peak Cold Cough plus Chest Congestion DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150709 OTC MONOGRAPH FINAL part341 Aurohealth LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 58602-118_6cd04008-9b66-4cd8-a596-55babf282387 58602-118 HUMAN OTC DRUG Aurotussin Peak Cold sugar-free COUGH PLUS CHEST CONGESTION DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150421 OTC MONOGRAPH FINAL part341 Aurohealth LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 58602-120_727788d0-0ba5-453b-ae20-c5bbdca80b00 58602-120 HUMAN OTC DRUG AuroFlu Flu and Sore Throat Warming Relief Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl SYRUP ORAL 20150221 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 58602-123_14759673-25e5-4a0f-bea9-facca29cf619 58602-123 HUMAN OTC DRUG Aurophen Cold and Flu Severe acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 58602-124_56b2c84e-ca39-4273-9e6b-aa7c3df6da79 58602-124 HUMAN OTC DRUG AuroFlu Day Time Severe Cold and Cough Warming Relief Acetaminophen, Dextromethorphan HBr and Phenylephrine HCl SYRUP ORAL 20150221 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 58602-125_b17f59f8-b385-4923-a8a0-76e0d4f37046 58602-125 HUMAN OTC DRUG AuroQuil COLD and FLU Day Time Multi-Symptom Relief Acetaminophen, Phenylephrine HCl, and Dextromethorphan HBr SOLUTION ORAL 20150727 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 58602-127_b6727737-41db-42fe-b82e-696d92afff71 58602-127 HUMAN OTC DRUG Aurophen Cold Multi Symptom acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 58602-128_b3699ab2-2196-4b7f-b92b-4ce55d719345 58602-128 HUMAN OTC DRUG Aurophen Cold Multi-Symptom Severe acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 58602-130_710f91ff-3d0a-47e6-9153-4b05487f750f 58602-130 HUMAN OTC DRUG Aurophen Cold Multi Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20150430 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 58602-132_35e08973-05f3-4b98-84bf-a36afd4f1254 58602-132 HUMAN OTC DRUG AuroQuil Cough Nighttime Cough Relief Dextromethorphan HBr and Doxylamine succinate SOLUTION ORAL 20150727 OTC MONOGRAPH FINAL part341 Aurohealth LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 58602-136_0c570abc-d231-4bd3-9bd0-0f69fc4b7dd0 58602-136 HUMAN OTC DRUG AuroQuil COLD and FLU Nighttime Relief Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr SOLUTION ORAL 20150727 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 58602-137_85786b70-09a6-4e45-8c32-12ba6e10bac3 58602-137 HUMAN OTC DRUG AuroQuil Cold and Flu Nighttime Relief Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr SOLUTION ORAL 20150209 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 58602-138_5ac59b9e-79fd-48d7-915d-56fc8ebbab38 58602-138 HUMAN OTC DRUG AuroMucus - Childrens Multi-Symptom Cold Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20150525 OTC MONOGRAPH FINAL part341 Aurohealth LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 58602-140_524ef65d-08f9-45ab-8976-d88b5b56ce85 58602-140 HUMAN OTC DRUG AuroFlu Night Time Severe Cold and Cough Warming Relief Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl SYRUP ORAL 20150221 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 58602-143_2a00467a-1bde-48ff-9134-71838a8a69be 58602-143 HUMAN OTC DRUG Aurotussin Peak Cold Maximum Strength Multi-Symptom Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL LIQUID ORAL 20160219 OTC MONOGRAPH FINAL part341 Aurohealth LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 58602-144_6ee329e4-4854-4a1d-8db8-8a904af227d8 58602-144 HUMAN OTC DRUG Aurotussin Peak Cold Multi-Symptom Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL LIQUID ORAL 20150619 OTC MONOGRAPH FINAL part341 Aurohealth LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 58602-145_60d72902-388b-453e-ba62-2f8262fb1ddc 58602-145 HUMAN OTC DRUG Childrens Daytime Cold and Cough Dextromethorphan HBr, Phenylephrine hydrochloride LIQUID ORAL 20150813 OTC MONOGRAPH FINAL part341 Aurohealth LLC DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 58602-148_a40704aa-9795-4457-b505-ab4693acc0a9 58602-148 HUMAN OTC DRUG AuroQuil Severe Cold and Flu Nighttime Relief acetaminophen, phenylephrine hcl, doxylamine succinate and dextromethorphan hbr SOLUTION ORAL 20150531 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 58602-149_c9bfead2-a2b8-4adf-a01e-5c1ed06c59f5 58602-149 HUMAN OTC DRUG AuroQuil Severe Cold and Flu Daytime Relief acetaminophen, phenylephrine hcl, dextromethorphan hbr and guaifenesin SOLUTION ORAL 20150601 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 58602-150_1d3f2e93-007a-45ee-8dad-78db1ac104d9 58602-150 HUMAN OTC DRUG AuroMucus Fast Maximum Night Time Cold and Flu Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl SOLUTION ORAL 20171202 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 58602-151_9ce150cd-c29d-47e7-854b-896e7b10847b 58602-151 HUMAN OTC DRUG AuroMucus - Fast Maximum DM MAX Dextromethorphan Hydrobromide and Guaifenesin SOLUTION ORAL 20150718 OTC MONOGRAPH FINAL part341 Aurohealth LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 58602-152_1f0baa3f-41fc-40e6-8023-398296dc3e02 58602-152 HUMAN OTC DRUG AuroMucus - Childrens Stuffy Nose and Cold Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20150629 OTC MONOGRAPH FINAL part341 Aurohealth LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 100; 2.5 mg/5mL; mg/5mL N 20181231 58602-153_f276089a-b031-46e0-bf5a-4ea486a19425 58602-153 HUMAN OTC DRUG Childrens Aurotussin Cough and Chest Congestion DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Aurohealth LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 58602-154_0151bdb7-14ff-4e10-b7a6-1cd1241393b3 58602-154 HUMAN OTC DRUG Childrens Aurotussin Cough and Cold CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Aurohealth LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 58602-155_c731e7e1-cff6-423e-a313-4a48cf2722a8 58602-155 HUMAN OTC DRUG Aurotussin Mucus plus Chest Congestion (ORIGINAL) Guaifenesin LIQUID ORAL 20150626 OTC MONOGRAPH FINAL part341 Aurohealth LLC GUAIFENESIN 200 mg/10mL N 20181231 58602-157_7f029c3b-1c5d-4d3c-8e52-48b3ad250aaa 58602-157 HUMAN OTC DRUG Auro Mucus - Childrens Cold, Cough and Sore Throat Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20160503 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL N 20181231 58602-158_9764eaf2-3cbc-45a0-8f59-bb224d15dcd8 58602-158 HUMAN OTC DRUG Auromine Childrens Cold and Allergy Brompheniramine maleate and Phenylephrine HCl SOLUTION ORAL 20151215 OTC MONOGRAPH FINAL part341 Aurohealth LLC BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL N 20181231 58602-160_1907bc20-4282-4261-9ace-919068372caf 58602-160 HUMAN OTC DRUG Aurotussin Maximum Strength Daytime and Nighttime Cough Relief Dextromethorphan HBr, Guaifenesin, Dextromethorphan HBr, Doxylamine Succinate KIT 20160527 OTC MONOGRAPH FINAL part341 Aurohealth LLC N 20181231 58602-161_4407c31f-6a50-4a58-81d1-81c537529c17 58602-161 HUMAN OTC DRUG AuroFlu Night Time Severe Cold and Cough Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl SYRUP ORAL 20160609 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 58602-162_25ab3bb8-e5fb-4a81-8e28-b5d2d748e045 58602-162 HUMAN OTC DRUG AUROFLU DAY TIME SEVERE COLD AND COUGH acetaminophen, dextromethorphan hbr and phenylephrine hcl SYRUP ORAL 20160609 OTC MONOGRAPH FINAL part341 Aurohealth LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 58602-203_bb5671d9-3741-434c-a6c7-86ac62e5799e 58602-203 HUMAN OTC DRUG Aurophen Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20150430 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-204_6cc921b9-d56b-4e85-b268-8787bb3177f4 58602-204 HUMAN OTC DRUG Aurophen Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20150428 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-205_27013568-9925-42ae-9de7-1d50d4569d96 58602-205 HUMAN OTC DRUG Aurophen Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20150427 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-206_b94ae3b6-8d1f-4922-aabd-8e524d4fdf09 58602-206 HUMAN OTC DRUG Aurophen Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20150430 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-207_88939f30-eb0a-44aa-b3c4-f01bd2cf8886 58602-207 HUMAN OTC DRUG Aurophen Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20150428 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-208_3d63ef62-2c2e-4655-8d9c-653aebf03225 58602-208 HUMAN OTC DRUG Aurophen Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20150708 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-210_6859cf0e-4805-410f-9c26-4bf960886579 58602-210 HUMAN OTC DRUG Aurophen Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20150430 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-214_d501e1af-a546-4259-8784-372cffac1a06 58602-214 HUMAN OTC DRUG Aurophen Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20150921 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-215_b69e4fba-a749-457e-8523-18b55158c7ed 58602-215 HUMAN OTC DRUG Aurophen - Adult Extra Strength Pain Reliever/Fever Reducer Acetaminophen LIQUID ORAL 20150505 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 500 mg/15mL N 20181231 58602-216_f690b17c-6359-4897-8c84-cf7db63d670b 58602-216 HUMAN OTC DRUG Aurophen Pain Away plus Sleep aid acetaminophen, diphenhydramine hydrochloride LIQUID ORAL 20150327 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/15mL; mg/15mL N 20181231 58602-217_b342a924-566c-48a0-860d-806a1fcbaaeb 58602-217 HUMAN OTC DRUG Aurophen Pain Away plus Sleep aid acetaminophen, diphenhydramine hydrochloride LIQUID ORAL 20150505 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/15mL; mg/15mL N 20181231 58602-218_e3729476-9b33-42d7-91a3-94b149c4586a 58602-218 HUMAN OTC DRUG Aurophen Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20150502 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-219_5f2d62be-8fe9-41c7-95c7-6642f7e832ca 58602-219 HUMAN OTC DRUG Aurophen Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20150502 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-220_f439eae5-3e49-4b9b-bacc-0996c27b0cda 58602-220 HUMAN OTC DRUG Aurophen Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20150502 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-221_30054101-3e9e-4da9-bc5c-abdab7a5898a 58602-221 HUMAN OTC DRUG Aurophen Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20150502 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-222_c69287bc-d54a-4f32-9ebd-d709634f6951 58602-222 HUMAN OTC DRUG Aurophen Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20150502 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-223_09aac8f9-6545-4bc3-9e36-2d6ecc5476e0 58602-223 HUMAN OTC DRUG Aurophen Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20150502 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58602-226_01e31b1c-caa4-4465-b12b-9a937451429b 58602-226 HUMAN OTC DRUG Aurophen Daytime Nighttime Acetaminophen, Diphenhydramine HCl KIT 20151104 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC N 20181231 58602-300_4c4faebf-5310-4e2b-8e01-8ff286430e1a 58602-300 HUMAN OTC DRUG Bismuth Subsalicylate Maximum Strength Stomach Relief Bismuth Subsalicylate LIQUID ORAL 20151229 OTC MONOGRAPH FINAL part335 Aurohealth LLC BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 58602-301_bab7f46b-b23c-4186-989d-fbd5655e836b 58602-301 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth Subsalicylate LIQUID ORAL 20170401 OTC MONOGRAPH FINAL part335 Aurohealth LLC BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 58602-302_dc86bcb3-dda1-47ba-94b8-6f2a8d6ca20a 58602-302 HUMAN OTC DRUG Stomach Relief Stomach Relief LIQUID ORAL 20170401 OTC MONOGRAPH FINAL part335 Aurohealth LLC BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 58602-321_28adfba8-b01d-47a9-aaf6-85b51971cf9b 58602-321 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide LIQUID ORAL 20160128 OTC MONOGRAPH NOT FINAL part334 Aurohealth LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 58602-322_7f7f66eb-71b6-4002-84c8-48d687044664 58602-322 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide LIQUID ORAL 20160128 OTC MONOGRAPH NOT FINAL part334 Aurohealth LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 58602-323_78244544-17a1-4a3f-a1ff-fb434786e613 58602-323 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide LIQUID ORAL 20160128 OTC MONOGRAPH NOT FINAL part334 Aurohealth LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 58602-422_9d61f049-f5c5-498f-a984-3fbe60902ee6 58602-422 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20100202 ANDA ANDA090750 Aurohealth LLC CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 58602-444_ec8cd9ba-2656-4d1b-98b6-55c1389c08da 58602-444 HUMAN OTC DRUG Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride TABLET ORAL 20150805 ANDA ANDA090760 Aurohealth LLC CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 58602-445_ec8cd9ba-2656-4d1b-98b6-55c1389c08da 58602-445 HUMAN OTC DRUG Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride TABLET ORAL 20150805 ANDA ANDA090760 Aurohealth LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 58602-446_49457a5e-9dea-4313-b2c4-0592131188fd 58602-446 HUMAN OTC DRUG Cetirizine Hydrochloride (Hives Relief) Cetirizine Hydrochloride TABLET ORAL 20150805 ANDA ANDA090760 Aurohealth LLC CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 58602-447_49457a5e-9dea-4313-b2c4-0592131188fd 58602-447 HUMAN OTC DRUG Cetirizine Hydrochloride (Hives Relief) Cetirizine Hydrochloride TABLET ORAL 20150805 ANDA ANDA090760 Aurohealth LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 58602-701_993f1207-6562-4d78-9f01-8fb90a3d2212 58602-701 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 20151215 ANDA ANDA206548 Aurohealth LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 58602-705_3bfb4b0e-8fe5-410f-8bcf-811e12495c27 58602-705 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20160426 ANDA ANDA206531 Aurohealth LLC FAMOTIDINE 10 mg/1 N 20181231 58602-706_1211891f-0ab7-4c50-86e9-6c9c5ff4aeab 58602-706 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20160426 ANDA ANDA206531 Aurohealth LLC FAMOTIDINE 20 mg/1 N 20181231 58602-710_792b3c77-940f-4021-b102-91313e24e7f4 58602-710 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20161005 ANDA ANDA202039 Aurohealth LLC FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 58602-711_792b3c77-940f-4021-b102-91313e24e7f4 58602-711 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20150115 ANDA ANDA202039 Aurohealth LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 58602-714_019fbba4-96bf-41a2-ab98-35f74a5be4d0 58602-714 HUMAN OTC DRUG Guaifenesin and Dextromethorphan HBr Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Aurohealth LLC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 600; 30 mg/1; mg/1 N 20181231 58602-715_e1d5f5de-e0d5-4d91-871c-1e6c0afa97bf 58602-715 HUMAN OTC DRUG Guaifenesin and Dextromethorphan HBr Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Aurohealth LLC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 58602-721_cd26e9c0-e685-4687-8a4a-16629b25fc35 58602-721 HUMAN OTC DRUG Athentia Next Levonorgestrel TABLET ORAL 20151208 ANDA ANDA206867 Aurohealth LLC LEVONORGESTREL 1.5 mg/1 N 20181231 58602-730_179c221d-c099-400c-b3ac-124e26947620 58602-730 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, EXTENDED RELEASE ORAL 20161109 ANDA ANDA207229 Aurohealth LLC ACETAMINOPHEN 650 mg/1 N 20181231 58602-733_65b08aa1-9742-4151-af53-ac1fe9478f4b 58602-733 HUMAN OTC DRUG RANITIDINE Ranitidine TABLET, FILM COATED ORAL 20171113 ANDA ANDA207579 Aurohealth LLC RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 58602-734_4a86408f-1b0b-4417-a670-734c6d6d8131 58602-734 HUMAN OTC DRUG MAXIMUM STRENGTH RANITIDINE Ranitidine TABLET ORAL 20171113 ANDA ANDA207578 Aurohealth LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 58602-738_2dfa820c-5130-43b0-9e63-19354bbbd3c3 58602-738 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20160318 ANDA ANDA205497 Aurohealth LLC NAPROXEN SODIUM 220 mg/1 N 20181231 58602-740_d0e4eb58-f3ea-4e51-b5fa-b5c39b472c5b 58602-740 HUMAN OTC DRUG Maximum Strength Ranitidine Ranitidine TABLET ORAL 20171113 ANDA ANDA207578 Aurohealth LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 58602-742_eca90b31-3bb5-40d4-8e87-ad3fcd74f887 58602-742 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20160301 OTC MONOGRAPH FINAL part341 Aurohealth LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 58602-743_994351af-0c08-436f-a623-149ff7c7c463 58602-743 HUMAN OTC DRUG Aurophen PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET ORAL 20160224 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 58602-754_8eda893f-5266-4b7a-95b9-2e194973cf06 58602-754 HUMAN OTC DRUG Aurophen Regular Strength Acetaminophen TABLET ORAL 20160226 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 325 mg/1 N 20181231 58602-755_a769094b-1e91-4ca7-ba67-21aa7e312910 58602-755 HUMAN OTC DRUG Aurophen Extra Strength for Adults Acetaminophen TABLET ORAL 20160226 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 500 mg/1 N 20181231 58602-765_00ec6518-b5e3-49d1-a342-139381c3bfd2 58602-765 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20170913 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/1 N 20181231 58602-766_49a740ec-8ed4-4c76-b2d0-c13651bafa5e 58602-766 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20170913 OTC MONOGRAPH NOT FINAL part343 Aurohealth LLC ACETAMINOPHEN 160 mg/1 N 20181231 58602-801_0ade8ee2-7c74-4b05-925e-d92742fc2b90 58602-801 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20171108 ANDA ANDA208865 Aurohealth LLC IBUPROFEN 200 mg/1 N 20181231 58602-802_cf6fbf3b-a0f3-4e08-a981-d183fa285758 58602-802 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20171108 ANDA ANDA208865 Aurohealth LLC IBUPROFEN 200 mg/1 N 20181231 58602-803_6adf9292-b4af-4cb4-99f3-dda03734570a 58602-803 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine HCl Ibuprofen and Pseudoephedrine HCl CAPSULE, LIQUID FILLED ORAL 20171201 ANDA ANDA209235 Aurohealth LLC IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 58602-804_1056d9da-8a3f-4b7a-878e-7f8d45d298cd 58602-804 HUMAN OTC DRUG Pseudoephedrine HCl Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20170609 ANDA ANDA209008 Aurohealth LLC PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 58602-807_4726af84-83c1-456d-995c-f6a8d1583f8b 58602-807 HUMAN OTC DRUG Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171030 ANDA ANDA209116 Aurohealth LLC FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 N 20181231 58602-809_b594f052-b6be-4d3b-9316-29cab050344a 58602-809 HUMAN OTC DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20171016 ANDA ANDA209339 Aurohealth LLC ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg/1 N 20181231 58602-812_ec8cd9ba-2656-4d1b-98b6-55c1389c08da 58602-812 HUMAN OTC DRUG Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride TABLET ORAL 20150805 ANDA ANDA090760 Aurohealth LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 58602-813_49457a5e-9dea-4313-b2c4-0592131188fd 58602-813 HUMAN OTC DRUG Cetirizine Hydrochloride (Hives Relief) Cetirizine Hydrochloride TABLET ORAL 20150805 ANDA ANDA090760 Aurohealth LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 58604-214_5a8145a5-061f-46aa-bb48-a282b91b627a 58604-214 HUMAN PRESCRIPTION DRUG ADDYI flibanserin TABLET, FILM COATED ORAL 20150818 NDA NDA022526 Sprout Pharmaceuticals, Inc. FLIBANSERIN 100 mg/1 P-Glycoprotein Inhibitors [MoA] N 20181231 58605-150_79c81ee6-bae5-45b4-93c8-7b896a0975e3 58605-150 HUMAN OTC DRUG BroveX PSB Pseudoephedrine Hydrochloride and Brompheniramine Maleate LIQUID ORAL 20071130 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 20; 4 mg/5mL; mg/5mL E 20171231 58605-151_b652e5a8-f339-4e39-b410-9e0857ffba3a 58605-151 HUMAN OTC DRUG BroveX PSB DM Pseudoephedrine Hydrochloride, Brompheniramine Maleate, and Dextromethorphan Hydrobromide LIQUID ORAL 20071130 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 20; 4; 20 mg/5mL; mg/5mL; mg/5mL E 20171231 58605-152_004dd25b-e97b-4264-b664-b3fee1ec4022 58605-152 HUMAN OTC DRUG BroveX PEB Brompheniramine Maleate and Phenylephrine Hydrochloride LIQUID ORAL 20071130 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/5mL; mg/5mL E 20171231 58605-153_6c2d7ce5-af0f-4a67-af49-ebe16e165dd4 58605-153 HUMAN OTC DRUG BroveX PEB DM Brompheniramine Maleate, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide LIQUID ORAL 20071130 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 4; 10; 20 mg/5mL; mg/5mL; mg/5mL E 20171231 58605-401_f8c0fb86-2639-485f-9eaf-769dc32e49ea 58605-401 HUMAN OTC DRUG Allfen DM GUAIFENESIN and Dextromethorphan Hydrobromide TABLET ORAL 20080331 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 E 20171231 58605-422_688d38bc-8d53-4103-8041-9da8184b73b6 58605-422 HUMAN OTC DRUG Maxiphen GUAIFENESIN and Phenylephrine Hydrochloride TABLET ORAL 20080331 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 E 20171231 58605-423_1a720629-daee-4f54-b8ed-6d0d69c9d1cd 58605-423 HUMAN OTC DRUG Maxiphen DM Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide TABLET ORAL 20080331 OTC MONOGRAPH FINAL part341 MCR American Pharmaceuticals, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 400; 10; 20 mg/1; mg/1; mg/1 E 20171231 58607-111_4f445831-63ec-4b5f-9135-a3074f518fcc 58607-111 HUMAN OTC DRUG Myferon 150 IRON SUCROSE CAPSULE ORAL 19961201 UNAPPROVED DRUG OTHER MARTIN EKWEALOR PHARMACEUTICALS, INC. IRON SUCROSE 150 mg/1 E 20171231 58607-112_24af9e28-be37-44a7-89c9-629f29b621e9 58607-112 HUMAN PRESCRIPTION DRUG Myferon 150 Forte IRON SUCROSE, FOLIC ACID, CYANOCOBALAMIN CAPSULE ORAL 19961201 UNAPPROVED DRUG OTHER MARTIN EKWEALOR PHARMACEUTICALS, INC. IRON SUCROSE; FOLIC ACID; CYANOCOBALAMIN 150; 1; 25 mg/1; mg/1; ug/1 Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 58607-113_07283557-cfb0-4689-8e9e-a0dd5c061fda 58607-113 HUMAN OTC DRUG FERROUS SULFATE FERROUS SULFATE TABLET ORAL 20140901 UNAPPROVED DRUG OTHER MARTIN EKWEALOR PHARMACEUTICALS, INC. FERROUS SULFATE; CALCIUM 65; 20 mg/1; mg/1 E 20171231 58607-185_f7c4547b-8ed1-47d0-a53b-664596953446 58607-185 HUMAN PRESCRIPTION DRUG Myhephron Dialysis and Stress Supplement ASCORBIC ACID, FOLATE, NIACIN, THIAMINE, RIBOFLAVIN, PYRIDOXINE, CYANOCOBALAMIN, PANTOTHENIC ACID, BIOTIN CAPSULE ORAL 20160801 UNAPPROVED DRUG OTHER Martin Ekwealor Pharmaceu ASCORBIC ACID; FOLIC ACID; NIACIN; THIAMINE; RIBOFLAVIN; PYRIDOXINE; CYANOCOBALAMIN; PANTOTHENIC ACID; BIOTIN 100; 1; 20; 1.5; 1.7; 10; 6; 5; 150 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 58607-186_2e082773-b3e5-4e5c-a1ca-058bcc4ae0e7 58607-186 HUMAN PRESCRIPTION DRUG MYNEPHROCAPS DIALYSIS/STRESS Vitamin Supplement ASCORBIC ACID, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CALCIUM PANTOTHENATE, THIAMINE MONONITRATE, FOLIC ACID, BIOTIN, CYANOCOBALAMIN CAPSULE ORAL 20131216 UNAPPROVED DRUG OTHER MARTIN EKWEALOR PHARMACEUTICALS, INC. ASCORBIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CALCIUM PANTOTHENATE; RIBOFLAVIN; THIAMINE MONONITRATE; FOLIC ACID; BIOTIN; CYANOCOBALAMIN 100; 20; 10; 5; 1.7; 1.5; 1; 150; 6 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 58607-700_7622102b-138b-4991-91dd-72eeeb58f2b8 58607-700 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 NF PEGyLAX POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20131216 UNAPPROVED DRUG OTHER MARTIN EKWEALOR PHARMACEUTICALS, INC. POLYETHYLENE GLYCOL 3350 17 g/17g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 58607-918_bb336c15-d70b-443e-b968-861d671f667e 58607-918 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE OINTMENT TOPICAL 20170304 UNAPPROVED DRUG OTHER MARTIN EKWEALOR PHARMACEUTICALS, INC. LIDOCAINE 2.5 g/50g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 58611-032_4934a7a8-43c3-727a-e054-00144ff88e88 58611-032 HUMAN OTC DRUG Phoenix KinetiCream Anti-inflammatory and Pain Relief MENTHOL CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part348 Phoenix Bioperformance Products, LLC MENTHOL 20 mg/mL N 20181231 58632-001_9b9a10c3-1c13-4cd1-abf8-7d35eac466d8 58632-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20050701 NDA NDA205712 GIBBS WELDING SUPPLY, INC. OXYGEN 990 mL/L N 20181231 58632-002_5f986870-4bce-4359-b4a6-40565949b490 58632-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20050701 NDA NDA205713 GIBBS WELDING SUPPLY, INC. NITROGEN 990 mL/L N 20181231 58633-223_264ee8f1-7679-4e47-8d49-4d43d54e18dd 58633-223 HUMAN OTC DRUG Correct and Perfect Spot Treatment Sulfur CREAM TOPICAL 20060905 OTC MONOGRAPH FINAL part333D Dr. Dennis Gross Skincare, LLC SULFUR 32.5 mg/g N 20181231 58633-231_dce8bb6d-1d82-44d8-8d63-a7740a6fce83 58633-231 HUMAN OTC DRUG CC SPF 18 Fair avobenzone, octinoxate CREAM TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part352 Dr. Dennis Gross Skincare, LLC AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 58633-232_dce8bb6d-1d82-44d8-8d63-a7740a6fce83 58633-232 HUMAN OTC DRUG CC SPF 18 Light to Medium avobenzone, octinoxate CREAM TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part352 Dr. Dennis Gross Skincare, LLC AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 58633-233_dce8bb6d-1d82-44d8-8d63-a7740a6fce83 58633-233 HUMAN OTC DRUG CC SPF 18 Medium avobenzone, octinoxate CREAM TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part352 Dr. Dennis Gross Skincare, LLC AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 58633-234_dce8bb6d-1d82-44d8-8d63-a7740a6fce83 58633-234 HUMAN OTC DRUG CC SPF 18 Medium to Dark avobenzone, octinoxate CREAM TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part352 Dr. Dennis Gross Skincare, LLC AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 58633-269_4036d87e-e4a0-455e-9368-241fcffa1117 58633-269 HUMAN OTC DRUG Clarifying Colloidal Sulfur Mask sulfur CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part333D Dr. Dennis Gross Skincare, LLC SULFUR 50 mg/g E 20171231 58633-315_1caaa824-9351-4fc8-9081-e98e83746280 58633-315 HUMAN OTC DRUG Dark Spot Sun Defense Broad Spectrum SPF 50 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20150424 OTC MONOGRAPH FINAL part352 Dr. Dennis Gross Skincare™, LLC TITANIUM DIOXIDE; ZINC OXIDE 49; 44.2 mg/mL; mg/mL E 20171231 58633-356_c97bf90e-969c-4f0e-85a5-506d734d667e 58633-356 HUMAN OTC DRUG Instant Radiance Sun Defense Sunscreen Broad Spectrum SPF 40 (Light - Medium) with sheer color correction technology Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20160603 OTC MONOGRAPH FINAL part352 Dr. Dennis Gross Skincare, LLC TITANIUM DIOXIDE; ZINC OXIDE 49; 44.2 mg/mL; mg/mL E 20171231 58633-357_c97bf90e-969c-4f0e-85a5-506d734d667e 58633-357 HUMAN OTC DRUG Instant Radiance Sun Defense Sunscreen Broad Spectrum SPF 40 (Medium-Deep) with sheer color correction technology Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20160603 OTC MONOGRAPH FINAL part352 Dr. Dennis Gross Skincare, LLC TITANIUM DIOXIDE; ZINC OXIDE 49; 44.2 mg/mL; mg/mL E 20171231 58638-002_8598fb94-a697-479f-a1de-6a2bd562d77f 58638-002 HUMAN OTC DRUG Angel of mine Diaper Rash Zinc Oxide OINTMENT TOPICAL 20170522 OTC MONOGRAPH FINAL part347 Wenzhou Senos Cosmetics Technology Co., Ltd. ZINC OXIDE 160 mg/g N 20181231 58657-150_2b5a7352-5958-042f-e054-00144ff88e88 58657-150 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20150301 ANDA ANDA091145 Method Pharmaceuticals, LLC FOLIC ACID 1 mg/1 N 20181231 58657-325_5e2f3983-0d25-4da4-9a3d-772e13aadc74 58657-325 HUMAN PRESCRIPTION DRUG Multi-Vitamin with Fluoride VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, CYANOCOBALAMIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE and SODIUM FLUORIDE LIQUID ORAL 20170224 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 2; 8; .4; .25 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; ug/mL; mg/mL; mg/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 58657-326_0a205bab-670e-46c1-9d38-bd85331405e3 58657-326 HUMAN PRESCRIPTION DRUG Multi-Vitamin with Fluoride VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, CYANOCOBALAMIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE and SODIUM FLUORIDE LIQUID ORAL 20170224 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; CYANOCOBALAMIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 2; 8; .4; .5 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; ug/mL; mg/mL; mg/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 58657-327_add37245-d7ac-4ced-9632-21dadfcd50d6 58657-327 HUMAN PRESCRIPTION DRUG Multi-Vitamin Drops with Fluoride and Iron VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, Ferrous sulfate and SODIUM FLUORIDE LIQUID ORAL 20170224 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FERROUS SULFATE; SODIUM FLUORIDE 1500; 35; 400; 5; .5; .6; 8; .4; 10; .25 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 58657-405_13655b57-fe4d-4547-a0b5-14fc839ac5e4 58657-405 HUMAN PRESCRIPTION DRUG ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE ESTERIFIED ESTROGENS, METHYLTESTOSTERONE TABLET ORAL 20170815 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE 1.25; 2.5 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 58657-406_13655b57-fe4d-4547-a0b5-14fc839ac5e4 58657-406 HUMAN PRESCRIPTION DRUG ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE ESTERIFIED ESTROGENS, METHYLTESTOSTERONE TABLET ORAL 20170815 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 58657-420_24546cf1-a567-4148-8b72-f59746e90da6 58657-420 HUMAN PRESCRIPTION DRUG Me-PB-Hyos Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide ELIXIR ORAL 20140601 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] CIV N 20181231 58657-421_d74273b6-ebea-41e6-8976-6115719023d5 58657-421 HUMAN PRESCRIPTION DRUG Me-PB-Hyos Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide TABLET ORAL 20140601 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 58657-430_71c6e0a5-cfaa-4e86-b77b-5413dca3e66b 58657-430 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20161123 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC SALSALATE 500 mg/1 E 20171231 58657-431_71c6e0a5-cfaa-4e86-b77b-5413dca3e66b 58657-431 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20161123 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC SALSALATE 750 mg/1 E 20171231 58657-450_34a8e57a-c520-4b83-9f59-0fb233f6c4be 58657-450 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl 100mg Phenazopyridine Hydrochloride TABLET ORAL 20141231 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 58657-451_3229ce1c-5439-4034-acf0-db8c1062ea04 58657-451 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl 200mg Phenazopyridine Hydrochloride TABLET ORAL 20141231 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 58657-454_2ae628e7-3b34-6a9a-e054-00144ff8d46c 58657-454 HUMAN PRESCRIPTION DRUG Me NaPhos MB Hyo 1 Urinary Antiseptic Antispasmodic TABLET ORAL 20151201 UNAPPROVED DRUG OTHER Method Pharmaceuticals METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; METHYLENE BLUE ANHYDROUS; HYOSCYAMINE SULFATE ANHYDROUS 81.6; 40.8; 10.8; .12 mg/1; mg/1; mg/1; mg/1 N 20181231 58657-456_0b1fc55e-7181-4426-afc8-c1cd4be64269 58657-456 HUMAN PRESCRIPTION DRUG Uro-MP Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate CAPSULE ORAL 20141201 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE 118; 40.8; 36; 10; .12 mg/1; mg/1; mg/1; mg/1; mg/1 Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 58657-458_37229472-72d0-07ee-e054-00144ff88e88 58657-458 HUMAN PRESCRIPTION DRUG Uro-458 Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate TABLET ORAL 20160617 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE 81; 40.8; 32.4; 10.8; .12 mg/1; mg/1; mg/1; mg/1; mg/1 Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] E 20171231 58657-478_a06021b5-133a-4180-a522-dc424ef29c8c 58657-478 HUMAN PRESCRIPTION DRUG Selenium Sulfide selenium sulfide SHAMPOO TOPICAL 20150601 UNAPPROVED DRUG OTHER Method Pharmaceuticals, LLC SELENIUM SULFIDE 22.5 mg/mL N 20181231 58657-500_ba9e285f-fb73-49bf-85c3-216127446c2a 58657-500 HUMAN OTC DRUG Codeine-Guaifenesin Codeine Phosphate and Guaifenesin SOLUTION ORAL 20140401 OTC MONOGRAPH FINAL part341 Method Pharmaceuticals, LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV N 20181231 58657-505_3903f28d-7022-69b0-e054-00144ff88e88 58657-505 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide SYRUP ORAL 20160614 OTC MONOGRAPH FINAL part341 Method Pharmaceuticals DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 58657-509_d5c54959-a0ff-45de-96d1-66d424a8e779 58657-509 HUMAN OTC DRUG Guaifenesin Guaifenesin LIQUID ORAL 20160209 OTC MONOGRAPH FINAL part341 Method Pharmaceuticals, LLC GUAIFENESIN 100 mg/5mL N 20181231 58657-510_276e2601-e01a-028d-e054-00144ff8d46c 58657-510 HUMAN OTC DRUG UTI-Pain PHENAZOPYRIDINE HYDROCHLORIDE 95 mg TABLET ORAL 20141110 UNAPPROVED DRUG OTHER Method Pharmaceuticals PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 E 20171231 58657-520_b32efb52-c973-4480-b82f-c3ebe106654d 58657-520 HUMAN OTC DRUG Acetaminophen Acetaminophen LIQUID ORAL 20150501 OTC MONOGRAPH NOT FINAL part343 Method Pharmaceuticals, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 58657-530_d9096de6-fc3c-4d31-a35d-4092a8e59d10 58657-530 HUMAN OTC DRUG M-Hist DM Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, LIQUID ORAL 20161111 OTC MONOGRAPH FINAL part341 Method Pharmaceuticals, LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 4; 15; 7.5 mg/5mL; mg/5mL; mg/5mL N 20181231 58657-535_a90163a7-daf6-4682-8b93-7f2518c9f1fd 58657-535 HUMAN OTC DRUG M-Hist PD TRIPROLIDINE HYDROCHLORIDE LIQUID ORAL 20161108 OTC MONOGRAPH FINAL part341 Method Pharmaceuticals, LLC TRIPROLIDINE HYDROCHLORIDE .625 mg/mL N 20181231 58657-605_39af022e-4753-49a9-85d4-3b6887f4bb20 58657-605 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol TABLET, FILM COATED ORAL 20171115 ANDA ANDA075215 Method Pharmaceuticals, LLC LABETALOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 58657-606_39af022e-4753-49a9-85d4-3b6887f4bb20 58657-606 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol TABLET, FILM COATED ORAL 20171115 ANDA ANDA075215 Method Pharmaceuticals, LLC LABETALOL 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 58657-607_39af022e-4753-49a9-85d4-3b6887f4bb20 58657-607 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol TABLET, FILM COATED ORAL 20171115 ANDA ANDA075215 Method Pharmaceuticals, LLC LABETALOL 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 58657-610_ad9dde78-b0cc-49b2-9c4a-98731e5847d0 58657-610 HUMAN PRESCRIPTION DRUG Losartan Losartan Potassium TABLET, FILM COATED ORAL 20150714 ANDA ANDA090382 Method Pharmaceuticals, LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 58657-611_ad9dde78-b0cc-49b2-9c4a-98731e5847d0 58657-611 HUMAN PRESCRIPTION DRUG Losartan Losartan Potassium TABLET, FILM COATED ORAL 20160920 ANDA ANDA090382 Method Pharmaceuticals, LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 58657-612_ad9dde78-b0cc-49b2-9c4a-98731e5847d0 58657-612 HUMAN PRESCRIPTION DRUG Losartan Losartan Potassium TABLET, FILM COATED ORAL 20160920 ANDA ANDA090382 Method Pharmaceuticals, LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 58657-620_aedea5a7-821d-4ddd-a977-c4c576cdfb04 58657-620 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160930 ANDA ANDA204989 Method Pharmaceuticals, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58657-621_aedea5a7-821d-4ddd-a977-c4c576cdfb04 58657-621 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160930 ANDA ANDA204989 Method Pharmaceuticals, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58657-622_aedea5a7-821d-4ddd-a977-c4c576cdfb04 58657-622 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160930 ANDA ANDA204989 Method Pharmaceuticals, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58657-623_9021bfb1-550b-4615-aff6-a8f4d49e9405 58657-623 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET ORAL 20161120 ANDA ANDA205101 Method Pharmaceuticals, LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58657-624_9021bfb1-550b-4615-aff6-a8f4d49e9405 58657-624 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET ORAL 20161120 ANDA ANDA205101 Method Pharmaceuticals, LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 58657-640_6d365eb8-1c12-4c3b-90f7-73cc789429f7 58657-640 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin hydrochloride TABLET ORAL 20170315 ANDA ANDA205096 Method Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 58657-641_6d365eb8-1c12-4c3b-90f7-73cc789429f7 58657-641 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin hydrochloride TABLET ORAL 20170315 ANDA ANDA205096 Method Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 58657-642_6d365eb8-1c12-4c3b-90f7-73cc789429f7 58657-642 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin hydrochloride TABLET ORAL 20170315 ANDA ANDA205096 Method Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 58657-680_a65d9d8e-d5f2-4e7d-a3ab-aea255f9fd87 58657-680 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20170415 ANDA ANDA202413 Method Pharmaceuticals, LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 58657-681_a65d9d8e-d5f2-4e7d-a3ab-aea255f9fd87 58657-681 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20170415 ANDA ANDA202413 Method Pharmaceuticals, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 58657-682_a65d9d8e-d5f2-4e7d-a3ab-aea255f9fd87 58657-682 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20170415 ANDA ANDA202413 Method Pharmaceuticals, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 58657-683_a5b44497-e37f-4815-ac47-cd869114fa1e 58657-683 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20170913 ANDA ANDA070772 Method Pharmaceuticals, LLC METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 58657-684_a5b44497-e37f-4815-ac47-cd869114fa1e 58657-684 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20170913 ANDA ANDA070773 Method Pharmaceuticals, LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 58657-850_312c228d-aae1-73dc-e054-00144ff88e88 58657-850 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20160209 ANDA ANDA091145 Method Pharmaceuticals, LLC FOLIC ACID 1 mg/1 N 20181231 58662-0001_87e82d98-5eb8-468e-80dc-848d793f3716 58662-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140804 NDA NDA205840 Home Medical Products & Services, LLC OXYGEN 1 L/L N 20181231 58665-001_b5fc2894-982e-4360-b0d6-d2e2b6661e55 58665-001 HUMAN OTC DRUG freshnails the undernail sanitizer Isopropyl Alcohol LIQUID TOPICAL 20131119 OTC MONOGRAPH NOT FINAL part333A TWB Strategic Investments Inc. ISOPROPYL ALCOHOL .7 mL/mL E 20171231 58666-3121_412e9df6-f046-4d33-894b-dc77a62ce893 58666-3121 HUMAN OTC DRUG Inflammation Therapy CALENDULA OFFICINALIS FLOWERING TOP SOAP TOPICAL 20130601 UNAPPROVED HOMEOPATHIC Sundial Group LLC CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/g N 20181231 58666-3122_62adc9c2-9915-4de3-9713-2c13b1b6fecc 58666-3122 HUMAN OTC DRUG Eczema and Psoriasis Therapy FUCUS VESICULOSUS, CENTELLA ASIATICA, MELISSA OFFICINALIS, ALOE SOAP TOPICAL 20130601 UNAPPROVED HOMEOPATHIC Sundial Group LLC FUCUS VESICULOSUS; CENTELLA ASIATICA; MELISSA OFFICINALIS; ALOE 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 58666-3412_355751a2-c489-6100-e054-00144ff8d46c 58666-3412 HUMAN OTC DRUG AFRICAN BLACK FACIAL CLEANSING BAR ANTI-ACNE CLARIFYING FUCUS VESICULOSUS, CENTELLA ASIATICA, MELISSA OFFICINALIS, ALOE SOAP TOPICAL 20160615 UNAPPROVED HOMEOPATHIC Sundial Group LLC FUCUS VESICULOSUS; CENTELLA ASIATICA; MELISSA OFFICINALIS; ALOE 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 58666-3413_5fc5dbad-9813-050c-e053-2a91aa0ae756 58666-3413 HUMAN OTC DRUG AFRICAN BLACK ACNE-PRONE FACE AND BODY BAR FUCUS VESICULOSUS, CENTELLA ASIATICA, MELISSA OFFICINALIS, ALOE SOAP TOPICAL 20171130 UNAPPROVED HOMEOPATHIC Sundial Group LLC FUCUS VESICULOSUS; CENTELLA ASIATICA; MELISSA OFFICINALIS; ALOE 1; 1; 1; 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 58668-0105_6174efa5-7100-44d5-a39f-db775c8e941e 58668-0105 HUMAN OTC DRUG BB SKIN PERFECTING BROAD SPECTRUM SPF 25 Titanium Dioxide - Sunscreen - Shade Light 01 TITANIUM DIOXIDE CREAM TOPICAL 20141118 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 47 mg/mL N 20181231 58668-0106_586ad322-9fa8-482b-a2ce-ea97e4d0d15f 58668-0106 HUMAN OTC DRUG BB SKIN PERFECTING BROAD SPECTRUM SPF 25 Titanium Dioxide - Sunscreen - Shade Medium 02 TITANIUM DIOXIDE CREAM TOPICAL 20141118 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 47 mg/mL N 20181231 58668-0107_c7fd99db-176d-4728-8617-94be8c137cc7 58668-0107 HUMAN OTC DRUG BB SKIN PERFECTING BROAD SPECTRUM SPF 25 Titanium Dioxide - Sunscreen - Shade Dark 03 TITANIUM DIOXIDE CREAM TOPICAL 20141118 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 47 mg/mL N 20181231 58668-0295_206c9ea4-372f-055f-e054-00144ff88e88 58668-0295 HUMAN OTC DRUG True Radiance B.S. SPF 15 Titanium Dioxide Sunscreen Tint 103 TITANIUM DIOXIDE CREAM TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-0296_206c9ea4-373f-055f-e054-00144ff88e88 58668-0296 HUMAN OTC DRUG True Radiance B.S. SPF 15 Titanium Dioxide Sunscreen Tint 105 TITANIUM DIOXIDE CREAM TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-0297_206b66f0-67e6-5626-e054-00144ff88e88 58668-0297 HUMAN OTC DRUG True Radiance B.S. SPF 15 Titanium Dioxide Sunscreen Tint 107 TITANIUM DIOXIDE CREAM TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-0298_206b66f0-67f6-5626-e054-00144ff88e88 58668-0298 HUMAN OTC DRUG True Radiance B.S. SPF 15 Titanium Dioxide Sunscreen Tint 108 TITANIUM DIOXIDE CREAM TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-0299_206c9ea4-3750-055f-e054-00144ff88e88 58668-0299 HUMAN OTC DRUG True Radiance B.S. SPF 15 Titanium Dioxide Sunscreen Tint 109 TITANIUM DIOXIDE CREAM TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-0300_206b66f0-6806-5626-e054-00144ff88e88 58668-0300 HUMAN OTC DRUG True Radiance B.S. SPF 15 Titanium Dioxide Sunscreen Tint 110 TITANIUM DIOXIDE CREAM TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-0302_205a2550-f316-0638-e054-00144ff88e88 58668-0302 HUMAN OTC DRUG True Radiance B.S. SPF 15 Titanium Dioxide Sunscreen Tint 112,5 TITANIUM DIOXIDE CREAM TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-0303_205a2d2c-561f-10a9-e054-00144ff88e88 58668-0303 HUMAN OTC DRUG True Radiance B.S. SPF 15 Titanium Dioxide Sunscreen Tint 112 TITANIUM DIOXIDE CREAM TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-0304_206c9ea4-3762-055f-e054-00144ff88e88 58668-0304 HUMAN OTC DRUG True Radiance B.S. SPF 15 Titanium Dioxide Sunscreen Tint 113 TITANIUM DIOXIDE CREAM TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-0305_206b66f0-6816-5626-e054-00144ff88e88 58668-0305 HUMAN OTC DRUG True Radiance B.S. SPF 15 Titanium Dioxide Sunscreen Tint 114 TITANIUM DIOXIDE CREAM TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-0679_acc295e2-a41f-4568-baf4-26122dc0f31c 58668-0679 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Titanium Dioxide-Sunscreen Extra-Firming Foundation Tint 105 TITANIUM DIOXIDE LIQUID TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL E 20171231 58668-0681_879e1b1b-0ed9-4ab7-b295-77d81ef6887d 58668-0681 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra Firming Day Wrinkle Lifting AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130220 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 58668-0741_9957ff77-7c10-4b4f-8424-22e034fb9512 58668-0741 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 20 Super Restorative Tinted Tint 02 TITANIUM DIOXIDE CREAM TOPICAL 20130219 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 70 mg/mL N 20181231 58668-0751_9128ed87-e7f5-487f-86a9-46447361a627 58668-0751 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 20 Super Restorative Tinted Tint 03 TITANIUM DIOXIDE CREAM TOPICAL 20130219 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 70 mg/mL N 20181231 58668-0761_f1e1a746-51ec-4b36-96e4-fd275d5384fb 58668-0761 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 20 Super Restorative Tinted Tint 04 TITANIUM DIOXIDE CREAM TOPICAL 20130219 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 68 mg/mL N 20181231 58668-0771_2c371349-a607-4afb-a75b-e5e92a992f75 58668-0771 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 20 Super Restorative Tinted Tint 05 TITANIUM DIOXIDE CREAM TOPICAL 20130219 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 63 mg/mL N 20181231 58668-0961_332f72bc-9108-4135-8a46-5d34b78e15a0 58668-0961 HUMAN OTC DRUG CLARINS Super Restorative Day Illuminating lifting replenishing BROAD SPECTRUM - SPF 20 - Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE CREAM TOPICAL 20130729 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 100; 27 mg/mL; mg/mL; mg/mL N 20181231 58668-1103_53058706-be6b-4c7e-9cc0-97f68f5a830b 58668-1103 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 15 - Sunscreen Multi-Active Day Early wrinkle correcting AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 50; 27 mg/mL; mg/mL; mg/mL N 20181231 58668-1139_6bf7803e-9b66-4e5b-9e18-e0a3abdefa9a 58668-1139 HUMAN OTC DRUG CLARINS HydraQuench Normal to Dry Skin Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE CREAM TOPICAL 20101001 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 50; 27 mg/mL; mg/mL; mg/mL N 20181231 58668-1140_89f0680b-5dc7-4264-915c-dfd6af58e0dd 58668-1140 HUMAN OTC DRUG CLARINS HydraQuench Normal to Combination Skin Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20121003 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 50; 27 mg/mL; mg/mL; mg/mL N 20181231 58668-1391_383b7d7a-e046-4d6c-be4f-d2ab301a821e 58668-1391 HUMAN OTC DRUG Super Restorative Foundation True Lift SPF 15 Tint 08 TITANIUM DIOXIDE CREAM TOPICAL 20110417 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL N 20181231 58668-1409_5728158b-5e65-4f0d-9e92-74a1b4f7958c 58668-1409 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 30 Sunscreen Care AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE,OXYBENZONE CREAM TOPICAL 20131217 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58668-1618_5f140357-091e-4a6a-b6d9-bebf75f1c7e7 58668-1618 HUMAN OTC DRUG CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -LIGHT HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE CREAM TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins HOMOSALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 40; 40; 15; 84 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58668-1619_f81742f5-32a6-43d8-88fb-735f30fdde63 58668-1619 HUMAN OTC DRUG Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint Medium HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE LIQUID TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins HOMOSALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 40; 40; 15; 84 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58668-1621_67461e0f-5496-40f4-946e-9d6559fddf1d 58668-1621 HUMAN OTC DRUG CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -DEEP HOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE CREAM TOPICAL 20150922 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins HOMOSALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 40; 40; 15; 84 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58668-1641_d1f89456-37bb-48fd-9f33-0fc7cd9bd79e 58668-1641 HUMAN OTC DRUG Clarins Vital Light Day SPF 15 HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20100930 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 100; 50; 30; 27 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 58668-1931_2c451e2e-c7cc-4897-9983-808844d7cf4a 58668-1931 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Titanium Dioxide-Sunscreen Extra-Firming Foundation Tint 103 TITANIUM DIOXIDE LIQUID TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL N 20181231 58668-1971_0fe2bf26-681d-44ef-9940-645f00f8ba49 58668-1971 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 107 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL N 20181231 58668-1981_fce986b5-0679-4263-b834-d1b87420e669 58668-1981 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 108 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL N 20181231 58668-1991_d93ba759-8bc2-419b-b3e5-3d4aa6570f57 58668-1991 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 109 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL N 20181231 58668-2001_3a3cc1b3-18a1-4e6b-bafe-52d540c19658 58668-2001 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 110 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL N 20181231 58668-2021_421791f4-78e1-4dd3-80b5-a861405b08e0 58668-2021 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 112 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL N 20181231 58668-2031_c3652841-f133-4742-a77c-5d36ab482f7e 58668-2031 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 113 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL N 20181231 58668-2041_fc2b160d-566c-4e54-b82c-3a4a92498fdf 58668-2041 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Sunscreen Extra-Firming Foundation Tint 114 TITANIUM DIOXIDE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 25 mg/mL N 20181231 58668-2131_b6956e8b-7720-4d89-ae18-2db6acf83702 58668-2131 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 103 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2141_1b472503-9654-42dd-9261-57680a9aaaf0 58668-2141 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 104 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2151_93f3fff7-8077-4443-b8aa-c780fda2f5a5 58668-2151 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 105 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2171_43c22f97-7115-43a0-a840-e8dcfa42dffb 58668-2171 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 107 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2181_28268ae9-1d34-4e85-b240-11eae921dc52 58668-2181 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 108 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2191_e855bba6-e60c-4a45-b531-ba7c5f14e334 58668-2191 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 109 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2201_cc29f37b-1d23-413b-8ef0-b05c11b4e1f0 58668-2201 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 110 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2211_d72df0cb-8275-4400-960c-b7dd0b64e9fc 58668-2211 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 111 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2221_bc1dccfc-f216-47d0-8d00-9a9d63b3ae46 58668-2221 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 112 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2231_e569d299-edb9-42c7-a620-805b5a669ef8 58668-2231 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 113 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2241_c4729b42-56a9-419e-a280-b09790e5ce5b 58668-2241 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 114 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2261_70aa36c3-637b-42bd-a40a-47c4ea1ba111 58668-2261 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 116 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2271_619050f0-1c01-b6f4-e053-2991aa0a8b54 58668-2271 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 117 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2281_3575ee6a-b7eb-4faa-9e63-f34cd7775d62 58668-2281 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 15 Everlasting Foundation Tint 118 TITANIUM DIOXIDE LIQUID TOPICAL 20130208 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 20 mg/mL N 20181231 58668-2561_67940109-4013-45c7-b3e7-3968772692b4 58668-2561 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 112.5 TITANIUM DIOXIDE LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2571_abd80ef1-c414-4ead-bd00-47c28ea931fb 58668-2571 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 115 TITANIUM DIOXIDE LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2581_7b30cc8a-9b43-478d-9a70-41e50d1ea9d2 58668-2581 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 116.5 TITANIUM DIOXIDE LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2591_27d73c85-7f82-4443-9c58-c271a9bbe13e 58668-2591 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 117 TITANIUM DIOXIDE LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2601_a3d8095b-daf5-4f6c-baff-94c4a6aa3519 58668-2601 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 118 TITANIUM DIOXIDE LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2631_9d671dbf-d9b5-4965-881c-bb4f1e00422d 58668-2631 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 103 TITANIUM DIOXIDE LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2641_61905da5-90bf-8cd2-e053-2a91aa0a0120 58668-2641 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 104 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2651_1ae49e4a-4aab-437f-b22a-0ad5840a342e 58668-2651 HUMAN OTC DRUG CLARINS SKIN ILLUSION Mineral and Plant Extracts SPF 10 Titanium Dioxide- Sunscreen - Natural Radiance Foundation Tint 105 TITANIUM DIOXIDE LIQUID TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2671_0c3e7e0f-0c0b-487e-af05-33b6ec34189c 58668-2671 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 107 TITANIUM DIOXIDE SOLUTION TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2681_702e0270-3ec4-47af-9764-1a6496b6036b 58668-2681 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 108 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2691_69ce928a-7da0-4a2b-b2d4-5e64cb2d1934 58668-2691 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 109 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2701_299dbe8d-bca3-4ff3-b7fa-0b6c26efb097 58668-2701 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 110 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2711_61905da5-90e4-8cd2-e053-2a91aa0a0120 58668-2711 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 111 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2721_b5ea7577-fc15-41ad-b25b-777bf4c89b53 58668-2721 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 112 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2731_5a324dd0-7d97-4cce-81e1-bc268aaee9f1 58668-2731 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 113 TITANIUM DIOXIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2741_ffbe56dc-b719-47d0-88e1-84307d0386cf 58668-2741 HUMAN OTC DRUG CLARINS Skin Illusion SPF 10 Natural Radiance Foundation Tint 114 TITANIUM DIOXIDE SOLUTION TOPICAL 20121101 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 18.9 mg/mL N 20181231 58668-2811_b64c5aa7-3769-45c7-9de6-cc46b0080bc6 58668-2811 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 107 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL N 20181231 58668-2821_c8d3bfb1-5c8f-4395-84d8-f9811f6ae1ea 58668-2821 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 108 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL N 20181231 58668-2831_3c511456-ed43-4174-b14c-7e99a39aa0da 58668-2831 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 109 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL N 20181231 58668-2841_48f0fcc9-cfe9-4396-9cfb-d8da97b40a6f 58668-2841 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 110 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL N 20181231 58668-2861_1ea06b48-622f-409b-82e8-10cb7ffa6c26 58668-2861 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 112 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL N 20181231 58668-2871_3b4a8131-dfef-4d6a-aa0c-de546efb9f38 58668-2871 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 113 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL N 20181231 58668-2881_c376631e-6cce-4713-9252-1ffad1629872 58668-2881 HUMAN OTC DRUG CLARINS Ever Matte Broad Spectrum SPF 15 Tint 114 TITANIUM DIOXIDE CREAM TOPICAL 20121011 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE 23 mg/mL N 20181231 58668-2901_941722a9-f06b-4356-974f-b18e63de5e80 58668-2901 HUMAN OTC DRUG CLARINS UV PLUS HP Broad Spectrum SPF 40 Sunscreen Multi-Protection Tint LIGHT TITANIUM DIOXIDE LIQUID TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 70 mg/mL N 20181231 58668-2911_fff8db77-61f4-4d56-890a-d8891b649216 58668-2911 HUMAN OTC DRUG CLARINS UV PLUS HP Broad Spectrum SPF 40 Sunscreen Multi-Protection Tint MEDIUM TITANIUM DIOXIDE SOLUTION TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 70 mg/mL N 20181231 58668-2921_61909779-9873-b41d-e053-2a91aa0a4b74 58668-2921 HUMAN OTC DRUG CLARINS UV PLUS HP Broad Spectrum SPF 40 Sunscreen Multi-Protection Tint DEEP TITANIUM DIOXIDE LIQUID TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 81 mg/mL N 20181231 58668-2951_b8533c10-293d-42b1-8cdb-e72f01904ade 58668-2951 HUMAN OTC DRUG CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED Sunscreen Multi-Protection HOMOSALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. HOMOSALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 40; 40; 150; 109 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58668-4011_038afd74-e846-4bcc-a909-c46de0d365c7 58668-4011 HUMAN OTC DRUG CLARINS Broad Spectrum SPF 30 Sunscreen For Face Wrinkle Control AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20130306 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58668-4021_0e37e14f-3fe3-4e16-b2a3-3903f8dfb291 58668-4021 HUMAN OTC DRUG Clarins Broad Spectrum SPF 30 Sunscreen for Sun-Sensitive Areas TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20120927 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A TITANIUM DIOXIDE; ZINC OXIDE 9.7; 3.8 g/100g; g/100g N 20181231 58668-4031_9ad70d63-028e-4a6d-94be-3495c26b34f9 58668-4031 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 50 Plus - SUNSCREEN FOR FACE WRINKLE CONTROL AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58668-4061_5029ed3d-4c98-4e10-b4ca-53b199268a06 58668-4061 HUMAN OTC DRUG Clarins Broad Spectrum SPF 15 Sunscreen Care For Outdoor Sports AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20131023 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58668-4081_6df288ea-b032-42d8-8631-7b90393826dd 58668-4081 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 20 - SUNSCREEN CARE AVOBENZONE, HOMOSALATE, OCTOCRYLENE CREAM TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 100; 27 mg/mL; mg/mL; mg/mL N 20181231 58668-4101_50e7738d-a6cc-49f3-b62d-f84cefbabbd7 58668-4101 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 50 Plus - SUNSCREEN CARE MILK AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58668-4561_ab5c0a44-1f4c-40d2-ab13-41ebbd9c56cc 58668-4561 HUMAN OTC DRUG CLARINS BROAD SPECTRUM SPF 30 SUNSCREEN CARE AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 27; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58668-5061_6182ec03-aef7-4c38-e053-2991aa0a8131 58668-5061 HUMAN OTC DRUG CLARINSMEN Antiperspirant ALL DAY DRY ALCOHOL-FREE ALUMINUM CHLOROHYDRATE STICK TOPICAL 20130506 OTC MONOGRAPH FINAL part350 Laboratoires Clarins S.A. ALUMINUM CHLOROHYDRATE 18 g/100g N 20181231 58668-5351_221b0c0a-37c4-4adb-bffa-30bc5fc0b409 58668-5351 HUMAN OTC DRUG Bronzing Duo SPF 15 Mineral Compact Tint 01 Light TITANIUM DIOXIDE POWDER TOPICAL 20120424 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 8.4 g/100g E 20171231 58668-5361_d7594dad-6e82-4464-9c68-6ab0fa0d5d2d 58668-5361 HUMAN OTC DRUG Bronzing Duo SPF 15 Mineral Compact Tint 02 Medium TITANIUM DIOXIDE POWDER TOPICAL 20120424 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 8.4 g/100g E 20171231 58668-5371_acf873c3-38b0-4a5a-bc85-25e8b94d9d25 58668-5371 HUMAN OTC DRUG Bronzing Duo SPF 15 Mineral Compact Tint 03 Dark TITANIUM DIOXIDE POWDER TOPICAL 20120424 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 8.4 g/100g E 20171231 58668-5961_954a1665-ba86-424a-af84-a91de361c1d0 58668-5961 HUMAN OTC DRUG CLARINS Roll-On Deodorant Anti-perspirant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130311 OTC MONOGRAPH FINAL part350 Laboratoires Clarins S.A. ALUMINUM CHLOROHYDRATE 180 mg/mL N 20181231 58668-6100_b3d4e4f9-64b0-4623-a44f-d9a0546ad80d 58668-6100 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 103 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-6120_a8eec44d-6f10-4536-a743-40b1670f70a3 58668-6120 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 105 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-6130_a539f5e4-73cd-4b63-8779-1bebee9ec77d 58668-6130 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 107 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-6140_5ce9e28b-c97c-46a0-a826-8dc1acfff419 58668-6140 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 108 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-6150_0c49ea9d-0062-4eeb-9e9a-d785e9f15760 58668-6150 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 109 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-6160_033953ff-67e1-4736-b8fb-0bb1a5572970 58668-6160 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 110 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-6180_b55d8a21-92fb-4fae-87b7-2ed4b231f249 58668-6180 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 112 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-6190_8fb8bf13-4fa5-4e81-8950-a82fb2f6a33d 58668-6190 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 113 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-6200_1579f4ee-5e06-4971-aafb-5c0c48ed156f 58668-6200 HUMAN OTC DRUG CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 114 TITANIUM DIOXIDE LIQUID TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-6800_4dc09a38-93a0-4f6b-a588-d93531941ab5 58668-6800 HUMAN OTC DRUG CLARINS BB Skin Perfecting Cream SPF 25 Tint 00 TITANIUM DIOXIDE LIQUID TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 47 mg/mL N 20181231 58668-7110_11776f23-d7b3-4335-9859-0c247f5e27f2 58668-7110 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 Ivory 103 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7120_9d79a812-41a5-42fe-910c-7565b32add13 58668-7120 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 Nude 105 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7130_6fff652f-c1ad-4356-b7e0-13f1c40493b0 58668-7130 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 beige 107 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7140_e42ed0f0-6e85-4bee-97b6-e5bd4b0cf7eb 58668-7140 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 sand 108 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7150_d0cd09d9-2a24-44e4-84db-9b1a3488ccef 58668-7150 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 wheat 109 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7160_139367e6-767e-4afe-8520-ac470f0dd0dd 58668-7160 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 honey 110 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7180_d93a15f9-eb2e-4707-a280-a3f64cf3e276 58668-7180 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 amber 112 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7190_80e32708-f54d-4bf4-86af-2981616823ab 58668-7190 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 caramel 112.5 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7200_ce6fb0aa-f456-4d9e-967e-51fe4d1b9c8b 58668-7200 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 chestnut 113 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7210_6d733b73-2e27-49a2-9bdb-594f4c62071a 58668-7210 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 capuccino 114 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7220_12e7c898-92de-4311-a10d-3517c1acf679 58668-7220 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 cognac 115 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7230_16b4f1ac-01b4-4f7b-b792-a5807a49a7c3 58668-7230 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 coffee 116.5 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7240_c8ad310d-1654-4c9f-8c9f-c7963c2c1220 58668-7240 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 hazelnut 117 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7250_595cac1c-30d6-4f59-95f4-e6db340ec3a2 58668-7250 HUMAN OTC DRUG EVERLASTING FOUNDATION Broad Spectrum SPF15 sienna 118 TITANIUM DIOXIDE CREAM TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins S.A. TITANIUM DIOXIDE 19 mg/mL N 20181231 58668-7251_1e3ee7cb-82f9-4e7e-b094-080c86f715c7 58668-7251 HUMAN OTC DRUG Clarins Self Tanning Milk With Sun Protection Spf 6 OCTINOXATE, AVOBENZONE SOLUTION TOPICAL 20120829 OTC MONOGRAPH FINAL part352 Laboratoires Clarins S.A. OCTINOXATE; AVOBENZONE 60; 20 mg/mL; mg/mL N 20181231 58668-9611_267c16fb-39a1-5be5-e054-00144ff88e88 58668-9611 HUMAN OTC DRUG Multi-Active Jour SPF 20 Broad Spectrum Sunscreen AVOBENZONE,HOMOSALATE,OCTOCRYLENE CREAM TOPICAL 20150924 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 90; 27 mg/mL; mg/mL; mg/mL N 20181231 58668-9612_6190939b-c467-b010-e053-2991aa0a4788 58668-9612 HUMAN OTC DRUG Hydra-Essential SPF 15 Broad Spectrum - SPF 15 - Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE CREAM TOPICAL 20160909 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 90; 27 mg/mL; mg/mL; mg/mL N 20181231 58668-9700_41e4df86-2e58-6281-e054-00144ff8d46c 58668-9700 HUMAN OTC DRUG Clarins Mission Perfection Yeux Broadspectrum SPF 15 Sunscreen TITANIUM DIOXIDE CREAM TOPICAL 20161118 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 84 mg/mL N 20181231 58668-9900_4a3c9565-5bab-27f4-e054-00144ff8d46c 58668-9900 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 103 TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9901_4a3c6a10-d24e-2015-e054-00144ff8d46c 58668-9901 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 105 TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9902_4a3c6a10-d251-2015-e054-00144ff8d46c 58668-9902 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 107 TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9903_4a3c6a10-d255-2015-e054-00144ff8d46c 58668-9903 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 108 TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9904_4a3c9565-5bb0-27f4-e054-00144ff8d46c 58668-9904 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 110 TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9905_4a3c6a10-d258-2015-e054-00144ff8d46c 58668-9905 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 112 TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9906_4a3c6a10-d25b-2015-e054-00144ff8d46c 58668-9906 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 103 Refill with sponge TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9907_4a3c9565-5bb3-27f4-e054-00144ff8d46c 58668-9907 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 105 Refill with sponge TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9908_4a3c9565-5bb6-27f4-e054-00144ff8d46c 58668-9908 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 107 Refill with sponge TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9909_4a3c9565-5bb9-27f4-e054-00144ff8d46c 58668-9909 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 108 Refill with sponge TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9910_4a3c6a10-d25e-2015-e054-00144ff8d46c 58668-9910 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 110 Refill with sponge TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9911_4a3c6a10-d261-2015-e054-00144ff8d46c 58668-9911 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 112 Refill with sponge TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9912_4a3c6a10-d264-2015-e054-00144ff8d46c 58668-9912 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 103 Tester refill with sponge TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9913_4a3cac55-11f3-5b9c-e054-00144ff88e88 58668-9913 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 105 Tester refill with sponge TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9914_4a3cac55-11f6-5b9c-e054-00144ff88e88 58668-9914 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 107 Tester refill with sponge TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9915_4a3c9565-5bbc-27f4-e054-00144ff8d46c 58668-9915 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 108 Tester refill with sponge TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9916_4a3c9565-5bbf-27f4-e054-00144ff8d46c 58668-9916 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 110 Tester refill with sponge TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9917_4a3cac55-11f9-5b9c-e054-00144ff88e88 58668-9917 HUMAN OTC DRUG Clarins Everlasting Cushion Long-Wearing and Hydrating Foundation Broad Spectrum SPF 50 Tint 112 Tester refill with sponge TITANIUM DIOXIDE EMULSION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins TITANIUM DIOXIDE 62 mg/mL N 20181231 58668-9918_6190cca0-9fe5-152e-e053-2991aa0a6bdf 58668-9918 HUMAN OTC DRUG CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE CREAM TOPICAL 20171005 OTC MONOGRAPH NOT FINAL part352 Laboratoires Clarins AVOBENZONE; HOMOSALATE; OCTOCRYLENE 30; 90; 65 mg/mL; mg/mL; mg/mL N 20181231 58686-013_a12a1bd5-c7b7-400f-a8f3-7c7350b61edd 58686-013 HUMAN OTC DRUG Shunfa Anti-Bacteria Spra Didecyldimethyl Ammonium,Triclosan, Borneol, Benzalkonium Bromide SPRAY TOPICAL 20051030 OTC MONOGRAPH NOT FINAL part333A Chengdu Shunfa Disinfection and Washing Technology Co Ltd DIDECYLDIMETHYLAMMONIUM; TRICLOSAN; BENZALKONIUM BROMIDE; BORNEOL 3; 3; 3; 4 mg/1000mg; mg/1000mg; mg/1000mg; mg/1000mg E 20171231 58690-1001_36986359-867e-49a7-bbdd-9101edd4366b 58690-1001 HUMAN OTC DRUG ZAREE All Kii Coconut Water Allantoin CREAM TOPICAL 20130527 OTC MONOGRAPH FINAL part347 G & NATURE Co., Ltd. ALLANTOIN .02 mg/mL E 20171231 58697-064_2d80ae24-1f9c-43d2-e054-00144ff88e88 58697-064 HUMAN OTC DRUG Optimis7 dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl LIQUID OPHTHALMIC 20110811 OTC MONOGRAPH FINAL part349 Pacific Health Collaborative, Inc. TETRAHYDROZOLINE HYDROCHLORIDE; DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE .5; 1; 10; 10 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58697-539_e4dcd54d-6561-47c7-ba02-b1fb494fdbd9 58697-539 HUMAN OTC DRUG Lurosil Menthol GEL TOPICAL 20130617 OTC MONOGRAPH NOT FINAL part348 Pacific Health Collabroative MENTHOL 2.5 g/100g E 20171231 58701-001_5d7af28d-338f-f6b6-e053-2a91aa0ad929 58701-001 HUMAN OTC DRUG First Class Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 American Airlines, Inc. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 58701-002_5d7aee26-0e6a-4fc3-e053-2991aa0a6192 58701-002 HUMAN OTC DRUG Business Class Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 American Airlines, Inc. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 58715-001_5d7b2b22-6e9b-a465-e053-2991aa0aeca3 58715-001 HUMAN OTC DRUG US Airways RON Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 US Airways, Inc SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 58722-9093_fcaa37cc-fa19-4f53-9e6b-512854c8b90a 58722-9093 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19840101 NDA NDA205865 Triweld Industries, Inc. OXYGEN 99 L/100L N 20191231 58722-9094_fcaa37cc-fa19-4f53-9e6b-512854c8b90a 58722-9094 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19840101 NDA NDA205865 Triweld Industries, Inc. OXYGEN 99 L/100L N 20191231 58733-001_5d7b3dec-0cf8-0573-e053-2a91aa0a59fe 58733-001 HUMAN OTC DRUG United Airlines Business Class Kit Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20130510 OTC MONOGRAPH FINAL part355 United Airlines SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 58737-101_69f500fc-e4ad-4727-b1d6-b1bb314bcd65 58737-101 HUMAN OTC DRUG Berry Scented Hand Sanitizer Cars Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg E 20171231 58737-102_9fa7a538-9899-4a58-9801-80da75630400 58737-102 HUMAN OTC DRUG Berry Scented Hand Sanitizer Mickey Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg E 20171231 58737-103_2799d74c-cab0-4287-957f-6f7b3d8f228d 58737-103 HUMAN OTC DRUG Berry Scented Hand Sanitizer Princesses Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg E 20171231 58737-104_c1b06a9f-75a0-4cdf-ae19-0eb9104456c9 58737-104 HUMAN OTC DRUG Berry Scented Hand Sanitizer Minnie Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg E 20171231 58737-105_12cb25be-dcdd-405c-ab36-364ea544248b 58737-105 HUMAN OTC DRUG Berry Scented Hand Sanitizer Girl Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg E 20171231 58737-106_657fc68d-e0bf-48e0-9e76-5f07e53412f8 58737-106 HUMAN OTC DRUG Berry Scented Hand Sanitizer Avengers Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg N 20181231 58737-107_9f65ef27-923a-40e6-9c8b-7b7654f7fe52 58737-107 HUMAN OTC DRUG Berry Scented Hand Sanitizer Spiderman Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .06 mg/59mg E 20171231 58737-108_c817fc08-5cbd-43d7-8c32-8f607eb8a203 58737-108 HUMAN OTC DRUG Fruit Punch Scented Hand Sanitizer Frozen Benzalkonium Chloride GEL TOPICAL 20140603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-109_b4dd1acc-f044-49d9-96e6-4b4462c23227 58737-109 HUMAN OTC DRUG Berry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-110_28eb5417-4f2d-4a20-9c91-ea32b82fc114 58737-110 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-111_72b55943-f948-42c7-839f-9b817f3c9200 58737-111 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-112_b98a4f88-ae3f-4544-b1f6-308424ae419f 58737-112 HUMAN OTC DRUG Raspberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-113_cb1ff1c8-4601-40ad-9065-0dcf2e9c4617 58737-113 HUMAN OTC DRUG Mixed Berries Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-114_c2df5c36-d973-4758-b218-3ad7e4f2eafd 58737-114 HUMAN OTC DRUG Cotton Candy Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-115_8dba6972-c27d-447c-bf7c-61b4b67d07f0 58737-115 HUMAN OTC DRUG Fruit Punch Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-116_b8aac9fe-c878-4683-b6b1-cb5db1a5e00a 58737-116 HUMAN OTC DRUG Cotton Candy Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-117_ab1126a0-9a12-4d5d-b7f1-aaf33fd02c03 58737-117 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-118_600cd12f-b8a6-4be3-9ea3-173375718567 58737-118 HUMAN OTC DRUG Bubble Gum Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-119_779b10a6-93b1-4c37-83c0-470944066c8e 58737-119 HUMAN OTC DRUG Raspberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-120_6edfb33d-730f-4799-91d9-a1ea03481d12 58737-120 HUMAN OTC DRUG Cotton Candy Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-121_c415d8c7-5d5d-411d-ba92-79be1856251e 58737-121 HUMAN OTC DRUG Boov-El Gum Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-122_385367b6-8307-4d77-bfd1-6052b908f46d 58737-122 HUMAN OTC DRUG Fruit Punch Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-123_4f8bc4ac-43e9-425f-a9e8-b335f75f062b 58737-123 HUMAN OTC DRUG Grape Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-124_b3845d8f-7513-4427-9464-2332d8de7256 58737-124 HUMAN OTC DRUG Bubble Gum Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-125_56d0595c-dcb7-4540-b5de-86b1371c108c 58737-125 HUMAN OTC DRUG Berry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-126_5dc04831-e7e0-4269-bc32-3b431c08bd33 58737-126 HUMAN OTC DRUG Strawberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-127_54879657-5f66-4257-a9ce-67b0713e4085 58737-127 HUMAN OTC DRUG Mixed Berries Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g E 20171231 58737-128_33bd8c88-8e23-4617-e054-00144ff88e88 58737-128 HUMAN OTC DRUG Fruit Punch Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Townley, Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-129_33bd9235-792e-6b7a-e054-00144ff8d46c 58737-129 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Townley, Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-130_33113d9f-d1cb-332e-e054-00144ff88e88 58737-130 HUMAN OTC DRUG Cherry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Townley, Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-131_331224cd-4457-4a82-e054-00144ff8d46c 58737-131 HUMAN OTC DRUG Bubblegum Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Townley, Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-132_33128e92-5ef3-7480-e054-00144ff8d46c 58737-132 HUMAN OTC DRUG Watermelon Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Townley, Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-133_33128e92-5efa-7480-e054-00144ff8d46c 58737-133 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Townley, Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-134_33128e92-5f01-7480-e054-00144ff8d46c 58737-134 HUMAN OTC DRUG Cherry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Townley, Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-135_331224cd-446c-4a82-e054-00144ff8d46c 58737-135 HUMAN OTC DRUG Bubblegum Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Townley, Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-136_331224cd-4470-4a82-e054-00144ff8d46c 58737-136 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Townley, Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-137_3da795a8-f792-124c-e054-00144ff88e88 58737-137 HUMAN OTC DRUG Strawberry Scented Hand Sanitizer Frozen Benzalkonium Chloride GEL TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-138_346074c1-49e8-18fd-e054-00144ff8d46c 58737-138 HUMAN OTC DRUG Bubblegum Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-139_3461126c-9785-4ef9-e054-00144ff88e88 58737-139 HUMAN OTC DRUG Watermelon Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-140_3da8843c-e8c6-164d-e054-00144ff8d46c 58737-140 HUMAN OTC DRUG Grape Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-141_3461b708-0f8e-585c-e054-00144ff8d46c 58737-141 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-142_34b68636-291a-3dae-e054-00144ff8d46c 58737-142 HUMAN OTC DRUG Hand Sanitizer Emoji 6 pack Emoji 6 pack Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-143_34637be0-10eb-2fb2-e054-00144ff88e88 58737-143 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Smile Tongue Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-144_3464086a-030b-4532-e054-00144ff88e88 58737-144 HUMAN OTC DRUG Mixed Berry Scented Hand Sanitizer Girl Hand Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-145_346476ab-2a20-52e8-e054-00144ff88e88 58737-145 HUMAN OTC DRUG Strawberry Scented Hand Sanitizer Crown Benzalkonium Chloride GEL TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-146_34659398-1c3c-27dd-e054-00144ff8d46c 58737-146 HUMAN OTC DRUG Watermelon Scented Hand Sanitizer Heart Eyes Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-148_34654cec-f0b3-1d9a-e054-00144ff8d46c 58737-148 HUMAN OTC DRUG Strawberry Scented Hand Sanitizer Anna Benzalkonium Chloride GEL TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-149_3465f482-1fa9-3731-e054-00144ff8d46c 58737-149 HUMAN OTC DRUG Bubble Gum Scented Hand Sanitizer Olaf 2 Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-150_34660afe-07b2-3b6a-e054-00144ff8d46c 58737-150 HUMAN OTC DRUG Grape Scented Hand Sanitizer Anna Elsa 2 Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-151_34b54c47-6a33-65de-e054-00144ff8d46c 58737-151 HUMAN OTC DRUG Hand Sanitizer Frozen 6 pack Frozen 6pack Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-152_3463e5e4-692f-2d4d-e054-00144ff88e88 58737-152 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Captain America Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-153_34a09ab5-6e1c-4af0-e054-00144ff88e88 58737-153 HUMAN OTC DRUG Raspberry Scented Hand Sanitizer Nightmare Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-154_34a0288a-7a18-716b-e054-00144ff8d46c 58737-154 HUMAN OTC DRUG Grape Scented Hand Sanitizer Nightmare 2 Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-155_34642528-3801-5d59-e054-00144ff8d46c 58737-155 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Nightmare 3 Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-157_346411e3-1bcb-4652-e054-00144ff88e88 58737-157 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Nightmare 5 Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-158_34c749a6-a5a0-02ba-e054-00144ff8d46c 58737-158 HUMAN OTC DRUG Hand Sanitizer Secret Pets 4-pack secret pets 4 pack Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-159_34b2fc63-8c31-18c8-e054-00144ff8d46c 58737-159 HUMAN OTC DRUG Hand Sanitizer Secret Pets 4 Pack Secret Pets 4 Pack Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-160_34b5a5ce-991e-1525-e054-00144ff8d46c 58737-160 HUMAN OTC DRUG Hand Sanitizer troll 6 pack troll 6 pack Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-161_34ca8ec4-783e-053e-e054-00144ff88e88 58737-161 HUMAN OTC DRUG Cotton Candy Scented Hand Sanitizer secret pets Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-162_39bc30d5-f93f-696e-e054-00144ff88e88 58737-162 HUMAN OTC DRUG Avengers Marvel Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-163_3ac55f9d-b290-1534-e054-00144ff8d46c 58737-163 HUMAN OTC DRUG Mickey Mouse Berry Scented Hand sanitizer Club house Benzalkonium Chloride GEL TOPICAL 20160823 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-164_3ac55f9d-b2a6-1534-e054-00144ff8d46c 58737-164 HUMAN OTC DRUG Lion Guard 5 pack Hand Sanitizer Lion Guard Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-165_3ac55f9d-b2a3-1534-e054-00144ff8d46c 58737-165 HUMAN OTC DRUG DisneyTsum Tsum Bubble Gum (pink) Hand Sanitizer DisneyTsum Tsum Benzalkonium Chloride GEL TOPICAL 20160823 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-166_3ac5d1ca-4c80-5f73-e054-00144ff88e88 58737-166 HUMAN OTC DRUG Disney Tsum Tsum Bubble Gum (purple) Hand Sanitizer Tsum Tsum - purple Benzalkonium Chloride GEL TOPICAL 20160823 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-167_3ac5d1ca-4c8c-5f73-e054-00144ff88e88 58737-167 HUMAN OTC DRUG Marvel 2 pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160823 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-168_3ac5d1ca-4cbc-5f73-e054-00144ff88e88 58737-168 HUMAN OTC DRUG Secret life of pets 4 pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-170_3ae64b5a-7afc-6239-e054-00144ff88e88 58737-170 HUMAN OTC DRUG BFF 2 pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-171_3ae64b5a-7b0a-6239-e054-00144ff88e88 58737-171 HUMAN OTC DRUG Emoji Smile Face Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-172_3ae71258-a8b7-6eb5-e054-00144ff88e88 58737-172 HUMAN OTC DRUG Disney Princess 6 Pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-173_3ae7bc63-e318-1980-e054-00144ff88e88 58737-173 HUMAN OTC DRUG Princess Strawberry Scented Hand Sanitizer Disney Princess Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-174_3ae7f3f3-dfd4-1658-e054-00144ff88e88 58737-174 HUMAN OTC DRUG Trolls Cotton Candy Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-175_3ae831e6-02be-4662-e054-00144ff8d46c 58737-175 HUMAN OTC DRUG Trolls Blueberry scented Hand Sanitizer Trolls Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-176_3ae834c2-87e7-2875-e054-00144ff88e88 58737-176 HUMAN OTC DRUG MickMinn Forever 6 pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-177_3ae8af63-198d-6010-e054-00144ff8d46c 58737-177 HUMAN OTC DRUG MickMinn Forever Hand Sanitizer 6 pack Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-178_3ae8badf-f969-62fd-e054-00144ff8d46c 58737-178 HUMAN OTC DRUG Trolls 4 Pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-179_3afcd2bf-9502-11c9-e054-00144ff8d46c 58737-179 HUMAN OTC DRUG Emoji 4 Pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-180_3aeae1e4-152b-3bb3-e054-00144ff8d46c 58737-180 HUMAN OTC DRUG Trolls RaspberryScented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-181_3afcd2bf-94fa-11c9-e054-00144ff8d46c 58737-181 HUMAN OTC DRUG Tsum Tsum Cotton Candy Hand Sanitizer Disney Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-182_3b015d11-76c7-0057-e054-00144ff8d46c 58737-182 HUMAN OTC DRUG Tsum Tsum Strawberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-183_3b0ddde4-6baf-3d12-e054-00144ff88e88 58737-183 HUMAN OTC DRUG Tsum Tsum Watermelon Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-184_3b0ddde4-6bc4-3d12-e054-00144ff88e88 58737-184 HUMAN OTC DRUG Disney Tsum Tsum Raspberry Scented Hand sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-185_3b0f158b-a14c-687f-e054-00144ff8d46c 58737-185 HUMAN OTC DRUG Disney princess 4pack Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-186_3b0f8ed5-ac81-6544-e054-00144ff88e88 58737-186 HUMAN OTC DRUG Disney BFF Bubble gum Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-187_3b4a56aa-5345-675b-e054-00144ff8d46c 58737-187 HUMAN OTC DRUG Emoji Smile Face Lemon scented Hand Sanitizer Emoji Benzalkonium Chloride GEL TOPICAL 20160830 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-188_3d84e023-0b46-085c-e054-00144ff8d46c 58737-188 HUMAN OTC DRUG Trolls 4pack Hand Sanitizer TD0260WA Benzalkonium Chloride GEL TOPICAL 20160927 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-189_3d855130-ee3d-1b53-e054-00144ff8d46c 58737-189 HUMAN OTC DRUG Tsum Tsum 3 Pack Hand Sanitizer TT0051WA Benzalkonium Chloride GEL TOPICAL 20160927 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-190_3d855130-ee4a-1b53-e054-00144ff8d46c 58737-190 HUMAN OTC DRUG Lion Guard 3pack Hand Sanitizer LG0007WA Benzalkonium Chloride GEL TOPICAL 20160927 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-191_465fe42f-c8bf-668f-e054-00144ff88e88 58737-191 HUMAN OTC DRUG Emoji Blueberry Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Townley Inc. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 58737-192_465f7bf4-7975-05a5-e054-00144ff8d46c 58737-192 HUMAN OTC DRUG Emoji Strawberry Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 58737-193_3d84eadc-47da-2f54-e054-00144ff88e88 58737-193 HUMAN OTC DRUG Frozen 4 pack Hand Sanitizer FZ0726WA Benzalkonium Chloride GEL TOPICAL 20160927 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-194_466078d0-f4ad-2c07-e054-00144ff8d46c 58737-194 HUMAN OTC DRUG Emoji Mixed Berry Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Townley Inc. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 58737-195_3d855130-ee63-1b53-e054-00144ff8d46c 58737-195 HUMAN OTC DRUG Marvel Superman Cherry Hand Sanitizer MV0037SA Benzalkonium Chloride GEL TOPICAL 20160927 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-196_3d85ac59-b640-362a-e054-00144ff88e88 58737-196 HUMAN OTC DRUG Marvel Avengers Lemon Scented Hand Sanitizer MV0031SA Benzalkonium Chloride GEL TOPICAL 20160927 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-197_466078d0-f550-2c07-e054-00144ff8d46c 58737-197 HUMAN OTC DRUG Emoji Watermelon Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Townley Inc. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 58737-198_3d85da72-c9bc-1ab1-e054-00144ff8d46c 58737-198 HUMAN OTC DRUG Trolls 2 pack Hand Sanitizer TD0178WA Benzalkonium Chloride GEL TOPICAL 20160927 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-199_3d85da72-c9cb-1ab1-e054-00144ff8d46c 58737-199 HUMAN OTC DRUG Trolls 4pack-277 Hand Sanitizer TD0277WA Benzalkonium Chloride GEL TOPICAL 20160927 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-200_42ec722e-983b-2ec4-e054-00144ff88e88 58737-200 HUMAN OTC DRUG Fruit Punch Scented Hand Sanitizer Disney Frozen Benzalkonium Chloride GEL TOPICAL 20161205 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-201_466078d0-f566-2c07-e054-00144ff8d46c 58737-201 HUMAN OTC DRUG Hulk Grape Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Townley Inc. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 58737-202_4660e731-2913-1332-e054-00144ff88e88 58737-202 HUMAN OTC DRUG Captain America Blueberry Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Townley Inc. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 58737-203_4660dacb-6dd0-1137-e054-00144ff88e88 58737-203 HUMAN OTC DRUG Iron Man Fruit Punch Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Townley Inc. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 58737-204_4660e731-2979-1332-e054-00144ff88e88 58737-204 HUMAN OTC DRUG Spiderman Watermelon Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E Townley Inc. BENZALKONIUM CHLORIDE .059 g/59mL N 20181231 58737-205_4e3afb1e-8e0a-03e4-e054-00144ff8d46c 58737-205 HUMAN OTC DRUG Despicable Me Berry Benzalkonium Chloride GEL TOPICAL 20170428 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-206_4e3c2929-61ae-3d9c-e054-00144ff8d46c 58737-206 HUMAN OTC DRUG Despicable Me Watermelon Benzalkonium Chloride GEL TOPICAL 20170428 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-207_4e3c2507-3f34-39a5-e054-00144ff8d46c 58737-207 HUMAN OTC DRUG Despicable Me Bubble Gum Benzalkonium Chloride GEL TOPICAL 20170428 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-208_4f43dc9e-08c4-0f0f-e054-00144ff88e88 58737-208 HUMAN OTC DRUG Frozen Cotton Candy Benzalkonium Chloride GEL TOPICAL 20170511 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-209_4f44b745-2ded-3ca2-e054-00144ff8d46c 58737-209 HUMAN OTC DRUG My Little Pony Cotton Candy Benzalkonium Chloride GEL TOPICAL 20170511 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-211_4f4541df-76d5-351b-e054-00144ff88e88 58737-211 HUMAN OTC DRUG Patriotic Blueberry Scented Benzalkonium Chloride GEL TOPICAL 20170511 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-212_4f457a86-b896-5b53-e054-00144ff8d46c 58737-212 HUMAN OTC DRUG Wall Climbing Cherry Scented Benzalkonium Chloride GEL TOPICAL 20170511 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-213_4f44f613-247c-488d-e054-00144ff8d46c 58737-213 HUMAN OTC DRUG Tangled Raspberry Scented Benzalkonium Chloride GEL TOPICAL 20170511 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-214_50e84f9c-d702-35ac-e054-00144ff88e88 58737-214 HUMAN OTC DRUG Cotton Candy/Grape/Bubble Gum/Cherry/Watermelon/Lemon Scented Benzalkonium Chloride GEL TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-215_50fa6894-114b-73d5-e054-00144ff88e88 58737-215 HUMAN OTC DRUG My Little Pony Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-216_536b87ba-5d71-18db-e054-00144ff8d46c 58737-216 HUMAN OTC DRUG My Little Pony Strawberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20170703 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-217_536f948f-5e17-12d4-e054-00144ff8d46c 58737-217 HUMAN OTC DRUG My Little Pony Hand Sanitizer Set Benzalkonium Chloride GEL TOPICAL 20170703 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58737-218_56692e8a-058a-5fd3-e054-00144ff88e88 58737-218 HUMAN OTC DRUG Grape Scented Hand Sanitizer My Little Pony Benzalkonium Chloride GEL TOPICAL 20170810 OTC MONOGRAPH NOT FINAL part333E Townley, Inc. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 58737-219_575a35ea-72cc-6dea-e053-2a91aa0a8f1a 58737-219 HUMAN OTC DRUG My Little Pony Cotton Candy Scented Benzalkonium Chloride GEL TOPICAL 20170822 OTC MONOGRAPH NOT FINAL part333A Townley Inc. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 58748-001_8e1662ad-37ac-4216-b2f7-d85d8aebe0e6 58748-001 HUMAN OTC DRUG Cotta Sodium Hyaluronate, Snail Secretion Filtrate, Morus Alba Bark Extract FILM, EXTENDED RELEASE TOPICAL 20130701 UNAPPROVED DRUG OTHER ECO INDUSTRY CO., LTD HYALURONATE SODIUM; GARDEN SNAIL MUCIN; MORUS ALBA ROOT BARK .3; .1; .1 g/100g; g/100g; g/100g E 20171231 58755-0001_2b4c4f4f-0a87-4af2-a8ac-5c9effc93982 58755-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950915 UNAPPROVED MEDICAL GAS Browning's Pharmacy and Healthcare Inc. OXYGEN 99 L/100L E 20171231 58766-010_4b513608-bfd2-44bd-e054-00144ff88e88 58766-010 HUMAN OTC DRUG SnowBalm Baby ZINC OXIDE OINTMENT TOPICAL 20170321 OTC MONOGRAPH FINAL part347 Snow Pharmaceuticals, LLC ZINC OXIDE .085 g/g N 20181231 58766-020_4b51e1e7-74dc-4507-e054-00144ff8d46c 58766-020 HUMAN OTC DRUG SnowBalm Adult ZINC OXIDE OINTMENT TOPICAL 20170321 OTC MONOGRAPH FINAL part347 Snow Pharmaceuticals, LLC ZINC OXIDE .085 g/g N 20181231 58789-001_62291510-9dec-4804-ae5b-c94f4cb227f5 58789-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Airgas Northern California and Nevada, Inc. OXYGEN 992 mL/L E 20171231 58789-002_11bc9e36-54fc-49ed-9474-2cbc639c5628 58789-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Airgas Northern California and Nevada, Inc. NITROGEN 992 mL/L E 20171231 58789-003_8ff0d4f1-9da8-47ae-8325-d76240146ceb 58789-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Airgas Northern California and Nevada, Inc. CARBON DIOXIDE 992 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 58789-005_6869fd3c-cdaa-4626-a9cd-f8427c76011a 58789-005 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Airgas Northern California and Nevada, Inc. HELIUM 999 mL/L E 20171231 58789-006_ff7d204f-2c35-42b1-a264-4209c27fdcf5 58789-006 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Airgas Northern California and Nevada, Inc. NITROUS OXIDE 992 mL/L E 20171231 58789-500_9b8e952f-7f55-43c7-944d-581de60cd875 58789-500 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19650101 UNAPPROVED MEDICAL GAS Airgas Northern California and Nevada, Inc. AIR 1000 mL/L E 20171231 58790-000_7dddff3c-a1cb-4019-887c-6f484c139725 58790-000 HUMAN OTC DRUG TheraTears Lubricant carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 19950101 OTC MONOGRAPH FINAL part349 Advanced Vision Research (Subsidiary of Akorn, Inc.) CARBOXYMETHYLCELLULOSE SODIUM 2.5 mg/mL E 20171231 58790-001_d1b54022-cedc-40b3-a5c3-bd8fe89ecbe4 58790-001 HUMAN OTC DRUG TheraTears Lubricant carboxymethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 19990701 OTC MONOGRAPH FINAL part349 Advanced Vision Research (Subsidiary of Akorn, Inc.) CARBOXYMETHYLCELLULOSE SODIUM 2.5 mg/mL N 20181231 58790-002_71cf00b4-5437-454a-a827-253383798df9 58790-002 HUMAN OTC DRUG TheraTears carboxymethylcellulose sodium GEL OPHTHALMIC 20021201 OTC MONOGRAPH FINAL part349 Advanced Vision Research (Subsidiary of Akorn, Inc.) CARBOXYMETHYLCELLULOSE SODIUM 10 mg/mL E 20171231 58790-008_1690a8bc-16a9-49d3-a554-ce976662e36e 58790-008 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION OPHTHALMIC 20120315 ANDA ANDA077958 Advanced Vision Research (Subsidiary of Akorn, Inc.) KETOTIFEN FUMARATE .35 mg/mL N 20181231 58790-301_f5b013f8-7d26-4eb8-bbe8-4b5fd77c8c60 58790-301 HUMAN OTC DRUG Allergy Eye Drops Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20131114 ANDA ANDA077958 Advanced Vision Research (Subsidiary of Akorn, Inc.) KETOTIFEN FUMARATE .35 mg/mL N 20181231 58805-001_108b7ac2-082d-47d4-a07d-58c50e40bb5c 58805-001 HUMAN OTC DRUG Diphenhydramine Hcl Diphenhydramine Hcl CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH FINAL part341 Agile Pharmachem DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 58805-002_641e15a2-c46c-4171-8918-4f752d79231d 58805-002 HUMAN OTC DRUG Acetaminophen,Dextromethorphan,Phenylephrine Acetaminophen,Dextromethorphan,Phenylephrine CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH FINAL part341 Agile Pharmachem ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 58805-003_2be66d41-01f7-4c72-9053-3a8206b90143 58805-003 HUMAN OTC DRUG Acetaminophen,Dextromethorphan,Doxylamine Acetaminophen,Dextromethorphan,Doxylamine CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH FINAL part341 Agile Pharmachem ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 10; 6.25 mg/1; mg/1; mg/1 E 20171231 58805-004_59a17ad9-395b-16b0-e053-2991aa0a9a40 58805-004 HUMAN OTC DRUG DAYTIME NIGHTTIME COLD/FLU acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl KIT ORAL 20140801 OTC MONOGRAPH FINAL part341 AGILE PHARMACHEM N 20181231 58805-006_7898db8a-f42d-435e-aaf4-5d4c6b81521c 58805-006 HUMAN OTC DRUG Nightime Sleep Aid Diphenhydramine CAPSULE, LIQUID FILLED ORAL 20140331 OTC MONOGRAPH FINAL part341 Agile Pharmachem DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 58805-006_8a592765-a0be-417d-9ca5-ba530235a986 58805-006 HUMAN OTC DRUG Nightime Sleep Aid Diphenhydramine CAPSULE, LIQUID FILLED ORAL 20140331 OTC MONOGRAPH FINAL part341 Agile Pharmachem DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 58805-007_4e88b254-c0b1-48bf-9ca5-b13a22118204 58805-007 HUMAN OTC DRUG Cough and Congestion DM Dextromethorphan and Guaifenesin CAPSULE, LIQUID FILLED ORAL 20151108 OTC MONOGRAPH FINAL part341 Agile Pharmachem DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 N 20181231 58809-116_3f7f4294-220f-49aa-a861-b2f60f865dd9 58809-116 HUMAN OTC DRUG TexaClear Nighttime Sleep-Aid Diphenhydramine HCl LIQUID ORAL 20160615 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 58809-123_181986d4-bf7c-58cd-e054-00144ff8d46c 58809-123 HUMAN OTC DRUG Vanapain Choline Salicylate, Caffeine LIQUID ORAL 20130722 OTC MONOGRAPH NOT FINAL part343 GM Pharmaceuticals, Inc. CHOLINE SALICYLATE; CAFFEINE 870; 65 mg/57mL; mg/57mL N 20181231 58809-186_1f11104a-879a-40e4-a1cd-9135112ace1e 58809-186 HUMAN OTC DRUG TexaClear Allergy Relief TABLET ORAL 20151201 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE 25; 50 mg/1; mg/1 N 20181231 58809-198_8c5e6d52-6f89-4885-a986-7f4d8cb7569f 58809-198 HUMAN OTC DRUG VanaTab DM Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET ORAL 20170301 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 198; 9; 5 mg/1; mg/1; mg/1 N 20181231 58809-211_ace6f147-d464-4b1b-9e75-490b8ea3e3a8 58809-211 HUMAN OTC DRUG DAYCLEAR ALLERGY RELIEF 8OZ Chlophedianol HCl, Pyrilamine Maleate LIQUID ORAL 20151020 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE 25; 50 mg/mL; mg/mL N 20181231 58809-312_e18f4e87-1b11-4af7-a728-94ec25d3db77 58809-312 HUMAN OTC DRUG DayClear SINUS PAIN AND PRESSURE Choline Salicylate, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20150810 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; CHOLINE SALICYLATE 200; 10; 870 mg/30mL; mg/30mL; mg/30mL N 20181231 58809-329_4c096ca6-f7fe-1b62-e054-00144ff88e88 58809-329 HUMAN OTC DRUG VanaCof AC Chlophedianol HCl, Pyrilamine Maleate LIQUID ORAL 20170301 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, Inc. PYRILAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE 25; 12.5 mg/30mL; mg/30mL N 20181231 58809-330_4c089fc6-794c-74ef-e054-00144ff8d46c 58809-330 HUMAN OTC DRUG VanaTab AC Chlophedianol HCl, Pyrilamine Maleate TABLET ORAL 20170301 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, Inc. PYRILAMINE MALEATE; CHLOPHEDIANOL HYDROCHLORIDE 25; 12.5 mg/1; mg/1 N 20181231 58809-346_8531377f-4864-492f-8372-cac44d9ca1d0 58809-346 HUMAN OTC DRUG TEXACLEAR CONGESTION AND PAIN SINUS RELIEF Choline Salicylate,Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20141021 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC GUAIFENESIN; CHOLINE SALICYLATE; PHENYLEPHRINE HYDROCHLORIDE 200; 870; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 58809-350_828f30bb-6409-4610-b6c6-9c60eb0426c4 58809-350 HUMAN OTC DRUG VANACOF-8 CHLOPHEDIANOL HYDROCHLORIDE and PYRILAMINE MALEATE LIQUID ORAL 20130601 OTC MONOGRAPH FINAL part341 GM PHARMACEUTICALS,INC CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE 25; 50 mg/15mL; mg/15mL E 20171231 58809-359_8f745286-3395-4de4-9ddd-8de47123e8da 58809-359 HUMAN PRESCRIPTION DRUG Vanatol S butalbital, acetaminophen and caffeine SYRUP ORAL 20170701 ANDA ANDA040387 GM Pharmaceuticals BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/15mL; mg/15mL; mg/15mL Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 58809-360_171073c0-6f71-4bb2-ac7e-c73a0bcb5aa3 58809-360 HUMAN OTC DRUG Texaclear Fast Acting Allergy Relief Chlophedianol Hydrochloride, Pyrilamine Maleate LIQUID ORAL 20141021 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE 25; 50 mg/30mL; mg/30mL N 20191231 58809-363_e295f573-8eb2-409e-aab7-934107449460 58809-363 HUMAN OTC DRUG Chlorphen SR Chlorpheniramine Maleate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100615 ANDA ANDA040829 GM Pharmaceuticals, INC CHLORPHENIRAMINE MALEATE 12 mg/1 N 20181231 58809-372_acd9df38-fe82-4172-9580-9d15f67b32c4 58809-372 HUMAN OTC DRUG TEXACLEAR NIGHT TIME COUGH COLD/FLU Choline Salicylate, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride LIQUID ORAL 20141023 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC CHOLINE SALICYLATE; PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE 870; 10; 50 mg/30mL; mg/30mL; mg/30mL N 20181231 58809-375_688e60d4-29b0-4c76-b180-51e2d19bfad8 58809-375 HUMAN OTC DRUG Z-Bum Diaper Rash Cream CREAM TOPICAL 20151201 OTC MONOGRAPH FINAL part347 GM Pharmaceuticals, INC ZINC OXIDE 22 g/100g N 20181231 58809-389_a22f4d9e-228c-4610-9cb0-710117260afc 58809-389 HUMAN OTC DRUG TEXACLEAR PAIN RELIEVER Caffeine, Choline salicylate LIQUID ORAL 20171214 OTC MONOGRAPH NOT FINAL part343 GM Pharmaceuticals, INC CHOLINE SALICYLATE; CAFFEINE 870; 65 mg/30mL; mg/30mL N 20191231 58809-390_0eda501a-35c5-415d-98a0-9cc21fefa987 58809-390 HUMAN OTC DRUG TEXACLEAR PM PAIN RELIEVER SLEEP AID Choline Salicylate, Diphenhydramine HCl LIQUID ORAL 20170315 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC CHOLINE SALICYLATE; DIPHENHYDRAMINE HYDROCHLORIDE 870; 50 mg/mL; mg/mL N 20181231 58809-391_45d3fc9b-1ec2-4c07-9ab0-5cecdc16390d 58809-391 HUMAN OTC DRUG TEXACLEAR DAYTIME COUGH COLD/FLU Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20141021 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC CHOLINE SALICYLATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN 870; 20; 10; 200 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 58809-413_0f6080ae-73ea-4a6c-8b07-1e687fb131fd 58809-413 HUMAN OTC DRUG DayClear COUGH COLD AND FLU Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20151020 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; CHOLINE SALICYLATE 20; 200; 10; 870 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 58809-444_1edb4799-f2db-1737-e054-00144ff8d46c 58809-444 HUMAN OTC DRUG Vanapain PM Choline Salicylate, Diphenhydramine Hydrochloride LIQUID ORAL 20131028 OTC MONOGRAPH NOT FINAL part343 GM Pharmaceuticals, Inc. CHOLINE SALICYLATE; DIPHENHYDRAMINE HYDROCHLORIDE 870; 50 mg/57mL; mg/57mL N 20181231 58809-485_e43a400f-534b-4299-bcd1-55cf8b2d3646 58809-485 HUMAN OTC DRUG VanaClear PD Triprolidine Hydrochloride LIQUID ORAL 20160404 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC TRIPROLIDINE HYDROCHLORIDE .313 mg/mL N 20181231 58809-501_facd8abc-52c6-4b67-9ad1-06299e756dec 58809-501 HUMAN OTC DRUG VANAHIST PD TRIPROLIDINE HYDROCHLORIDE LIQUID ORAL 20140319 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC TRIPROLIDINE HYDROCHLORIDE .625 mg/mL N 20181231 58809-514_d6468dfb-5d96-4770-8445-aa5528cba460 58809-514 HUMAN OTC DRUG NITECLEAR COLD AND FLU RELIEF Choline Salicylate, Diphenhydramine HCI, Phenylephrine HCl SOLUTION ORAL 20151020 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC CHOLINE SALICYLATE; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 870; 50; 10 mg/mL; mg/mL; mg/mL N 20191231 58809-555_8822b93b-72d9-449d-83bd-9d0eafac71e7 58809-555 HUMAN OTC DRUG VANACOF DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20130601 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 18; 200; 10 mg/15mL; mg/15mL; mg/15mL N 20181231 58809-643_2b045058-1997-408c-8fed-ebf78aa29502 58809-643 HUMAN OTC DRUG Vanamine PD Diphenhydramine Hydrochloride LIQUID ORAL 20160404 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC DIPHENHYDRAMINE HYDROCHLORIDE 6.25 mg/mL N 20181231 58809-725_8fd68a8d-c88f-4f08-b24c-9eac6e622851 58809-725 HUMAN PRESCRIPTION DRUG Active FE .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, MAGNESIUM OXIDE, ZINC OXIDE, and CUPRIC OXIDE TABLET ORAL 20131111 UNAPPROVED DRUG OTHER GM Pharmaceuticals, Inc. .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; IRON PENTACARBONYL; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE 2100; 160; 400; 40; 4; 4; 20; 20; 1250; 30; 75; 30; 20; 1 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] E 20171231 58809-729_a20ca9f3-4bdc-43ed-92bb-7c7e2f6217f8 58809-729 HUMAN OTC DRUG Nasopen PE Phenylephrine Hydrochloride, Thonzylamine Hydrochloride LIQUID ORAL 20121003 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC PHENYLEPHRINE HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE 10; 50 mg/15mL; mg/15mL N 20181231 58809-820_bc990056-c75f-4b0b-87f8-4fb9bdcd533c 58809-820 HUMAN PRESCRIPTION DRUG Vanatol LQ butalbital, acetaminophen and caffeine SYRUP ORAL 20150428 ANDA ANDA040387 GM Pharmaceuticals BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/15mL; mg/15mL; mg/15mL Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 58809-829_29e5426d-063b-4a87-80eb-8ba62c05478b 58809-829 HUMAN PRESCRIPTION DRUG Escavite D .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, HYDROXOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, FERROUS CYSTEINE GLYCINATE, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, and SODIUM FLUORIDE TABLET, CHEWABLE ORAL 20140303 UNAPPROVED DRUG OTHER GM Pharmaceuticals, INC .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; HYDROXOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; FERROUS CYSTEINE GLYCINATE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE; SODIUM FLUORIDE 2500; 100; 600; 30; 1.5; 1.7; 20; 2; 400; 6; 45; 10; 6; 60; 15; 2; .25 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Antidote [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 58809-877_5be3d3e7-349f-426c-b2c9-d95529ea5498 58809-877 HUMAN PRESCRIPTION DRUG ESCAVITE LQ VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FERRIC PYROPHOSPHATE, FERROUS CYSTEINE GLYCINATE, and SODIUM FLUORIDE LIQUID ORAL 20130820 UNAPPROVED DRUG OTHER GM Pharmaceuticals, INC VITAMIN A PALMITATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FERRIC PYROPHOSPHATE; FERROUS CYSTEINE GLYCINATE; SODIUM FLUORIDE 1500; 35; 400; 7.5; .5; .6; 8; .4; .9; 5; 1; .25 [iU]/mL; mg/mL; [iU]/mL; [iU]/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; mg/mL; mg/mL; mg/mL Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 58809-888_935bc301-7376-4676-8ba5-085e4463e5a2 58809-888 HUMAN PRESCRIPTION DRUG Escavite Sodium Fluoride, Vitamin A Acetate, Biotin, Magnesium, Zinc, Copper, Calcium Pantothenate, Folic Acid, Iron, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, and CYANOCOBALAMIN TABLET, CHEWABLE ORAL 20120201 UNAPPROVED DRUG OTHER GM Pharmaceuticals, Inc. SODIUM FLUORIDE; VITAMIN A ACETATE; BIOTIN; MAGNESIUM; ZINC; COPPER; CALCIUM PANTOTHENATE; FOLIC ACID; IRON; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN .25; 1000; 45; 60; 7.4; 1; 10; .4; 7.5; 100; 400; 30; 1.5; 1.7; 20; 2; 9 mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] E 20171231 58809-925_126d9b63-4ff4-46dc-a3b5-5cfee551c65c 58809-925 HUMAN OTC DRUG TexaClear Kids Allergy Chlophedianol HCl Pyrilamine Maleate LIQUID ORAL 20160615 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE 12.5; 25 mg/30mL; mg/30mL N 20181231 58809-945_65104cd2-b45a-4875-81cc-238df47453f1 58809-945 HUMAN OTC DRUG TexaClear Kids Sinus Relief Phenylephrine HCl Thonzylamine HCl LIQUID ORAL 20150615 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC THONZYLAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 50; 5 mg/30mL; mg/30mL N 20191231 58809-950_7eb896f4-1003-4c8f-a639-44dfdf064962 58809-950 HUMAN OTC DRUG TexaClear Kids Cough and Cold Dextromethorphan HBr Guaifenesin Phenyephrine HCl LIQUID ORAL 20150615 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 200; 5 mg/30mL; mg/30mL; mg/30mL N 20181231 58809-955_21da8674-dfbf-486b-a608-2644650f4320 58809-955 HUMAN OTC DRUG TexaClear Kids Cold Relief Diphenhydramine HCl Phenylephrine HCl LIQUID ORAL 20150615 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 25; 5 mg/30mL; mg/30mL N 20191231 58809-999_6e48017a-a48a-4b1a-8e4b-5d4003560de5 58809-999 HUMAN OTC DRUG VANACOF Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, and Pseudoephedrine Hydrochloride LIQUID ORAL 20080422 OTC MONOGRAPH FINAL part341 GM Pharmaceuticals, INC CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 12.5; 1; 30 mg/5mL; mg/5mL; mg/5mL N 20181231 58826-702_241d866f-6820-58d4-e054-00144ff8d46c 58826-702 HUMAN OTC DRUG COATS ALOE ALLANTOIN LOTION TOPICAL 20151010 OTC MONOGRAPH FINAL part347 TYCHASIS CORPORATION ALLANTOIN .5 g/100mL E 20171231 58826-703_21b3c8ef-7748-0045-e054-00144ff8d46c 58826-703 HUMAN OTC DRUG COATS ALOE ALLANTOIN CREAM TOPICAL 20151010 OTC MONOGRAPH FINAL part347 TYCHASIS CORPORATION ALLANTOIN 5 mg/g E 20171231 58826-704_215cfa24-8947-0e66-e054-00144ff8d46c 58826-704 HUMAN OTC DRUG COATS ALOE ANALGESIC METHYL SALICYLATE, ALOE LOTION TOPICAL 20150929 OTC MONOGRAPH NOT FINAL part348 TYCHASIS CORPORATION METHYL SALICYLATE 10 g/g E 20171231 58826-705_21b3c8ef-774a-0045-e054-00144ff8d46c 58826-705 HUMAN OTC DRUG COATS ALOE ALLANTOIN JELLY TOPICAL 20151010 OTC MONOGRAPH FINAL part347 TYCHASIS CORPORATION ALLANTOIN .5 g/100mL E 20171231 58831-1001_af3ce657-d6c9-4961-89f2-7eb15ecc63fa 58831-1001 HUMAN OTC DRUG EGF UV SHIELD OCTINOXATE CREAM TOPICAL 20130626 OTC MONOGRAPH NOT FINAL part352 Dermaesthetics Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE; AMILOXATE 7.5; 5; 4.9; 4.15; 2 g/60g; g/60g; g/60g; g/60g; g/60g N 20181231 58836-0972_be0ac0e2-7d33-4ac8-a5f3-0b9e1496de3a 58836-0972 HUMAN OTC DRUG Total Bromine Bromine LIQUID ORAL 20110729 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated BROMINE 15 [hp_X]/30mL E 20171231 58836-0973_5efbc82f-40c7-41f8-8ebf-4d69269d2231 58836-0973 HUMAN OTC DRUG Total Chlorine Chlorinum LIQUID ORAL 20110815 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated CHLORINE 15 [hp_X]/30mL E 20171231 58875-101_e0dd7b3f-fd21-4e0d-94a2-8603b38c9442 58875-101 HUMAN OTC DRUG Hard Candy Correction Creme Octinoxate, Octisalate CREAM TOPICAL 20130612 OTC MONOGRAPH NOT FINAL part352 Xtreme Color Inc. OCTINOXATE; OCTISALATE 2.55; 1.7 g/42.5g; g/42.5g E 20171231 58876-101_25a6216f-6a84-49d8-bd6b-bb2601bd99b0 58876-101 HUMAN OTC DRUG DAILY CLEANSER SALICYLIC ACID ACNE TREATMENT SALICYLIC ACID GEL TOPICAL 20130613 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE SALICYLIC ACID 2 g/100mL E 20171231 58876-102_a19b116f-e0fa-400a-a708-ac0315856c05 58876-102 HUMAN OTC DRUG ACNE CLEANSING PADS SALICYLIC ACID LIQUID TOPICAL 20130613 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE SALICYLIC ACID .02 g/1 N 20181231 58876-103_5f97983e-e7be-472e-a44b-05796179e59a 58876-103 HUMAN OTC DRUG ACNE SPOT CORRECTOR BENZOYL PEROXIDE CREAM TOPICAL 20130613 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE BENZOYL PEROXIDE 5 g/100mL E 20171231 58876-104_7cc5962a-40f8-419e-89fa-6503ce5fc044 58876-104 HUMAN OTC DRUG DR. LIN SKINCARE ACNE BENZOYL PEROXIDE LOTION TOPICAL 20130626 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE BENZOYL PEROXIDE 2.5 g/100mL E 20171231 58876-105_265c782f-bc67-48a4-a2f6-922bcd826913 58876-105 HUMAN OTC DRUG ACNE CLEANSING WIPES SALICYLIC ACID LIQUID TOPICAL 20130613 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE SALICYLIC ACID .02 g/1 N 20181231 58876-106_7dc59181-8f6a-40af-b5f6-5e5bada5d508 58876-106 HUMAN OTC DRUG ACNE SPOT CORRECTOR MAXIMUM STRENGTH BENZOYL PEROXIDE CREAM TOPICAL 20130613 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE BENZOYL PEROXIDE 10 g/100mL E 20171231 58876-107_8c7e10d0-e160-430e-8ef8-4ef95b7e1c13 58876-107 HUMAN OTC DRUG INTENSIVE FACE AND BODY ACNE TREATMENT BENZOYL PEROXIDE GEL TOPICAL 20140711 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE BENZOYL PEROXIDE 10 g/100mL E 20171231 58876-108_03bc5e2e-4880-4f53-9493-3fddd0566666 58876-108 HUMAN OTC DRUG MEDICATED ACNE SHOWER SALICYLIC ACID GEL TOPICAL 20130613 OTC MONOGRAPH FINAL part333D DR LIN SKINCARE SALICYLIC ACID 2 g/100mL E 20171231 58878-0001_4e463c16-09ed-44f0-b9e2-0d7f7d85e8f2 58878-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19901212 UNAPPROVED MEDICAL GAS Shasta Welding Supply, Inc. OXYGEN 99 L/100L E 20171231 58892-070_ef82223e-f4df-4917-baae-d305ad052fb6 58892-070 HUMAN OTC DRUG Cotz Plus SPF 58 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 100; 30 mg/g; mg/g E 20171231 58892-118_c8522483-b25f-4948-8976-a6a67d396454 58892-118 HUMAN OTC DRUG CoTZ SPF 35 Sunscreen Zinc Oxide LOTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. ZINC OXIDE 200 mg/g E 20171231 58892-125_5d4a9076-4a63-4ea3-8776-802e06fba806 58892-125 HUMAN OTC DRUG LipCoTZ Lip Balm/Sunscreen Titanium Dioxide, Zinc Oxide LIPSTICK TOPICAL 20050401 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 40; 55 mg/g; mg/g E 20171231 58892-126_e51f9ed7-389f-4b5b-b9b3-5a408350a7bb 58892-126 HUMAN OTC DRUG Cotz Lip Balm Lip Balm/Sunscreen Titanium Dioxide, Zinc Oxide LIPSTICK TOPICAL 20040102 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 40; 55 mg/g; mg/g E 20171231 58892-130_32eebeb8-ed24-42ce-b239-d2d75b30f79a 58892-130 HUMAN OTC DRUG Solar Protection Formula TiZO SheerFoam Sunscreen Titanium Dioxide, Zinc Oxide AEROSOL, FOAM TOPICAL 20120420 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 30; 100 mg/g; mg/g E 20171231 58892-218_7dd87237-d76f-45d1-a56d-d340efe81719 58892-218 HUMAN OTC DRUG Solar Protection Formula TiZO Body Sunscreen Zinc Oxide CREAM TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. ZINC OXIDE 200 mg/g E 20171231 58892-240_dbea6f0c-95d1-420f-85ff-b97845ca3018 58892-240 HUMAN OTC DRUG Solar Protection Formula LipTect Lip Balm/Sunscreen Titanium Dioxide, Zinc Oxide LIPSTICK TOPICAL 20040102 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 40; 55 mg/g; mg/g E 20171231 58892-265_0c5df784-589a-48e8-a719-f8e79609215b 58892-265 HUMAN OTC DRUG Solar Protection Formula SPF 65 Sunscreen Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20040102 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 60; 70; 40; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 58892-318_3279ee92-0ab5-498e-8483-3e7ee6a00824 58892-318 HUMAN OTC DRUG Solar Protection Formula TiZO SPF 35 Sunscreen Zinc Oxide LOTION TOPICAL 20120902 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. ZINC OXIDE 200 mg/g E 20171231 58892-326_2a630d89-3a34-4a56-a494-ba02b7a833ca 58892-326 HUMAN OTC DRUG Solar Protection Formula TiZO3 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20070521 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 85.4; 40.7 mg/mL; mg/mL E 20171231 58892-336_5d91737b-e62c-4647-9c70-2acccd9ec497 58892-336 HUMAN OTC DRUG Solar Protection Formula TiZO2 Light Skin Formula Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 85.4; 40.7 mg/mL; mg/mL E 20171231 58892-346_769c18c0-c9d3-4866-99e8-eb2b8680f58b 58892-346 HUMAN OTC DRUG FaceCoTZ (Sunscreen) Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 85.4; 40.7 mg/mL; mg/mL E 20171231 58892-347_31de0954-6db4-427d-8404-3095c0e7c057 58892-347 HUMAN OTC DRUG Cotz Face (For Lighter Skin Tones) SPF 40 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120719 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 80; 38 mg/g; mg/g E 20171231 58892-356_307df76d-c5b5-4c22-9507-05fcc5bf6d15 58892-356 HUMAN OTC DRUG Cotz Face (Natural Skin Tone) SPF 40 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120214 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 80; 38 mg/g; mg/g E 20171231 58892-418_7956ec06-a9ce-46d4-a721-e5c21ee1d18c 58892-418 HUMAN OTC DRUG Cotz Sensitive SPF 40 Sunscreen Zinc Oxide LOTION TOPICAL 20120330 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. ZINC OXIDE 200 mg/g E 20171231 58892-518_6d2bf152-c7e9-4e52-9615-dfe0120cab79 58892-518 HUMAN OTC DRUG Cotz Pediatric SPF 40 Sunscreen Zinc Oxide LOTION TOPICAL 20120907 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. ZINC OXIDE 200 mg/g E 20171231 58892-600_4d32c38b-7b9d-4c85-b279-af8d55c3b9b3 58892-600 HUMAN OTC DRUG Cotz Pure SPF 30 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120214 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 41; 84 mg/g; mg/g E 20171231 58892-721_eb1a06d9-31fc-4d5c-b8d7-cafd6a9cf6b7 58892-721 HUMAN OTC DRUG Solar Protection Formula SPF 60 Tinted Concealer - (Beige) Sunscreen Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 19940601 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 69; 81; 46; 115; 39 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 58892-722_eb1a06d9-31fc-4d5c-b8d7-cafd6a9cf6b7 58892-722 HUMAN OTC DRUG Solar Protection Formula SPF 60 Tinted Concealer - (Honey) Sunscreen Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 19940601 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 69; 81; 46; 115; 39 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 58892-723_eb1a06d9-31fc-4d5c-b8d7-cafd6a9cf6b7 58892-723 HUMAN OTC DRUG Solar Protection Formula SPF 60 Tinted Concealer - (Blush) Sunscreen Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 19940601 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 69; 81; 46; 115; 39 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 58892-910_62bf906c-ca32-4c8f-be85-a6832d1351ff 58892-910 HUMAN OTC DRUG CoTZ SPF 58 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20040102 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 100; 30 mg/g; mg/g E 20171231 58892-911_e5ac22f4-f5ae-4fde-9e79-eea783d371b9 58892-911 HUMAN OTC DRUG Solar Protection Formula SPF 58 Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20040102 OTC MONOGRAPH NOT FINAL part352 Fallien Cosmeceuticals, LTD. TITANIUM DIOXIDE; ZINC OXIDE 100; 30 mg/g; mg/g E 20171231 58894-101_7b2c3b0c-073f-4199-982f-aff7e709dc7e 58894-101 HUMAN OTC DRUG ALRA THERAPY ALLANTOIN LOTION TOPICAL 20160614 OTC MONOGRAPH FINAL part347 NEUE COSMETIC COMPANY INC ALLANTOIN .5 g/100mL E 20171231 58895-1001_896c4911-af27-4a5e-8015-17c5c83cfdc1 58895-1001 HUMAN OTC DRUG MODLINA PEPTIDE SOOTHING ESSENTIAL HYDROGEL MASK PACK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 Modlina Cosmetics Co., Ltd GLYCERIN .01 g/g E 20171231 58895-2001_f7ca6424-a2b7-42d4-851b-a104b0b2c2db 58895-2001 HUMAN OTC DRUG BEAUTIFUL WOMANS HAIR LOVES COLORFUL BUBBLES HAIR DYE 5N NATURAL BROWN P-AMINOPHENOL LIQUID TOPICAL 20130812 UNAPPROVED DRUG OTHER Modlina Cosmetics Co., Ltd P-AMINOPHENOL .01 mg/mL E 20171231 58895-3001_3b992f86-b32d-421f-b836-5d30a9174299 58895-3001 HUMAN OTC DRUG BEAUTIFUL WOMANS HAIR LOVES COLORFUL BUBBLES HAIR DYE 3N DARK BROWN P-PHENYLENEDIAMINE LIQUID TOPICAL 20130812 UNAPPROVED DRUG OTHER Modlina Cosmetics Co., Ltd P-PHENYLENEDIAMINE .01 mg/mL E 20171231 58906-0003_5b26a679-c992-3a8e-e053-2991aa0ac821 58906-0003 HUMAN OTC DRUG Angryhead Premium GLYCERIN SHAMPOO TOPICAL 20170930 OTC MONOGRAPH FINAL part358H DBIO Inc SALICYLIC ACID .2 g/100mL N 20181231 58906-0004_5b27dad8-ace7-3b26-e053-2a91aa0ae798 58906-0004 HUMAN OTC DRUG Angryhead Premium Hair Tonic salicylic acid LIQUID TOPICAL 20170930 OTC MONOGRAPH FINAL part358H DBIO Inc SALICYLIC ACID .1 g/100mL N 20181231 58906-1001_e5d14db1-45cf-4ee1-8ffe-c9530ae221b5 58906-1001 HUMAN OTC DRUG BURZANGMURY GOLD GLYCERIN SHAMPOO TOPICAL 20130801 OTC MONOGRAPH FINAL part347 Dae Deok bio Inc GLYCERIN .01 g/mL N 20181231 58906-2001_6a6181f1-82fc-47c4-b17e-6825f693f7a8 58906-2001 HUMAN OTC DRUG BURZANGMURY GOLD TREATMENT GLYCERIN LIQUID TOPICAL 20130816 OTC MONOGRAPH FINAL part347 Dae Deok bio Inc GLYCERIN .01 g/mL N 20181231 58912-1001_b5fb11da-e49e-4b90-b7d1-ffd1a4e626f7 58912-1001 HUMAN OTC DRUG Mirapharm-22 PANAX GINSENG WHOLE CAPSULE ORAL 20130725 UNAPPROVED DRUG OTHER Uni Bio-Tech Inc PANAX GINSENG WHOLE .06 mg/.3mg E 20171231 58912-2001_9994cd61-f81f-48f4-a699-69a033d85a32 58912-2001 HUMAN OTC DRUG Mirapharm-22 PANAX GINSENG WHOLE CAPSULE ORAL 20131116 UNAPPROVED DRUG OTHER Uni Bio-Tech Inc PANAX GINSENG WHOLE .3 g/1 E 20171231 58914-003_595ea486-da08-453b-b2a1-e4eb4abeef7c 58914-003 HUMAN PRESCRIPTION DRUG ULTRESA Pancrelipase CAPSULE, DELAYED RELEASE ORAL 20120301 NDA NDA022222 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 13800; 27600; 27600 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 58914-005_595ea486-da08-453b-b2a1-e4eb4abeef7c 58914-005 HUMAN PRESCRIPTION DRUG ULTRESA Pancrelipase CAPSULE, DELAYED RELEASE ORAL 20120301 NDA NDA022222 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 23000; 46000; 46000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 58914-006_595ea486-da08-453b-b2a1-e4eb4abeef7c 58914-006 HUMAN PRESCRIPTION DRUG ULTRESA Pancrelipase CAPSULE, DELAYED RELEASE ORAL 20150401 NDA NDA022222 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 4000; 8000; 8000 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 58914-012_b2368535-af02-4f4e-ade3-dae2cf5dbbb5 58914-012 HUMAN PRESCRIPTION DRUG Bentyl Dicyclomine hydrochloride CAPSULE ORAL 19500511 20180831 NDA NDA007409 Allergan, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 58914-013_b2368535-af02-4f4e-ade3-dae2cf5dbbb5 58914-013 HUMAN PRESCRIPTION DRUG Bentyl Dicyclomine hydrochloride TABLET ORAL 19500511 NDA NDA007409 Allergan, Inc. DICYCLOMINE HYDROCHLORIDE 20.6 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 58914-019_595ea486-da08-453b-b2a1-e4eb4abeef7c 58914-019 HUMAN PRESCRIPTION DRUG ULTRESA Pancrelipase CAPSULE, DELAYED RELEASE ORAL 20120301 NDA NDA022222 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 20700; 41400; 41400 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 58914-080_b2368535-af02-4f4e-ade3-dae2cf5dbbb5 58914-080 HUMAN PRESCRIPTION DRUG Bentyl Dicyclomine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR 19520813 NDA NDA008370 Allergan, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/2mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 58914-112_13dbf16d-db0e-4f1f-ac43-7a2badf8170f 58914-112 HUMAN PRESCRIPTION DRUG Viokace Pancrelipase TABLET ORAL 20120301 NDA NDA022542 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 10440; 39150; 39150 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 58914-117_13dbf16d-db0e-4f1f-ac43-7a2badf8170f 58914-117 HUMAN PRESCRIPTION DRUG Viokace Pancrelipase TABLET ORAL 20120301 NDA NDA022542 Allergan, Inc. PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE 20880; 78300; 78300 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 58914-170_2188233b-434b-4948-a35d-97f129ac691c 58914-170 HUMAN PRESCRIPTION DRUG Carafate Sucralfate SUSPENSION ORAL 19931216 NDA NDA019183 ALLERGAN SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 58914-171_023364e0-656d-47bd-b8bd-3ad21019417e 58914-171 HUMAN PRESCRIPTION DRUG Carafate Sucralfate TABLET ORAL 19811030 NDA NDA018333 ALLERGAN SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 58914-301_e9ebed29-5503-411c-bb35-b0658b3f0b5f 58914-301 HUMAN PRESCRIPTION DRUG Rectiv nitroglycerin OINTMENT RECTAL 20110621 NDA NDA021359 ALLERGAN NITROGLYCERIN 4 mg/g Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 58914-501_bcb9380c-f7f8-44b4-b453-c4feb7dd416b 58914-501 HUMAN PRESCRIPTION DRUG Canasa Mesalamine SUPPOSITORY RECTAL 20010105 NDA NDA021252 Allergan MESALAMINE 1000 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 58914-601_493e3ae0-30ac-42b5-90b3-75a6910e0bd2 58914-601 HUMAN PRESCRIPTION DRUG Pylera Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride CAPSULE ORAL 20130801 NDA NDA050786 Allergan, Inc. BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE 140; 125; 125 mg/1; mg/1; mg/1 Bismuth [Chemical/Ingredient],Bismuth [EPC],Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient],Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 58914-785_486d1e2c-5f7b-4d1b-8639-4589221d88ec 58914-785 HUMAN PRESCRIPTION DRUG Urso 250 Ursodiol TABLET, FILM COATED ORAL 19971210 NDA NDA020675 Allergan, Inc. URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 58914-790_486d1e2c-5f7b-4d1b-8639-4589221d88ec 58914-790 HUMAN PRESCRIPTION DRUG Urso Forte Ursodiol TABLET, FILM COATED ORAL 19971210 NDA NDA020675 Allergan, Inc. URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 58918-001_7973a696-a590-47ea-81eb-38a1f8a8e38d 58918-001 HUMAN OTC DRUG MAUI SURFER HONEY NATURAL SUNSCREEN ZINC OXIDE LOTION TOPICAL 20140307 OTC MONOGRAPH NOT FINAL part352 HAWAIIAN CLASSIC PERFUMES. INC ZINC OXIDE 200 mg/mL E 20171231 58918-002_e5f21b81-ee9a-46bb-a6a3-60f93916def8 58918-002 HUMAN OTC DRUG MAUI NATURALS ALL NATURAL SUNSCREEN ZINC OXIDE LOTION TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 HAWAIIAN CLASSIC PERFUMES. INC ZINC OXIDE 200 mg/mL E 20171231 58929-100_6d0ebb89-86ff-4f7f-97f7-0f8a63c63b6f 58929-100 HUMAN OTC DRUG Genuine Efficascent CAMPHOR, MENTHOL, METHYL SALICYLATE OIL TOPICAL 20100524 OTC MONOGRAPH FINAL part348 International Pharmaceuticals Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 1.45; 18.35 mL/100mL; mL/100mL; mL/100mL N 20181231 58929-200_610b5adf-ffe2-4015-9467-827ade97f056 58929-200 HUMAN OTC DRUG Omega Pain Relieving CAMPHOR, MENTHOL, METHYL SALICYLATE LINIMENT TOPICAL 20100524 OTC MONOGRAPH FINAL part348 International Pharmaceuticals, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 3.33; 14.775 mL/100mL; 1/100mL; mL/100mL N 20181231 58929-300_95c31a13-0e33-49fe-85f7-2ec9a04a0346 58929-300 HUMAN OTC DRUG DR. S. WONGS ACNE TREATMENT SULPHUR SULFUR SOAP TOPICAL 20100524 OTC MONOGRAPH FINAL part333 International Pharmaceuticals, Inc. SULFUR 3 g/100g N 20181231 58930-001_ac62cd6e-a3d8-49fc-9d67-3461f439be0f 58930-001 HUMAN OTC DRUG A.H.C Real Eye For Face Adenosine CREAM TOPICAL 20130621 UNAPPROVED DRUG OTHER Carver Korea Co Ltd ADENOSINE .12 mg/30mL N 20181231 58930-011_ccb26223-f304-45d0-948a-5300aacbade9 58930-011 HUMAN OTC DRUG A.H.C. C-SERUM Niacinamide CREAM TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE .6 g/30mL N 20181231 58930-012_90baa840-63f9-4bc5-a782-9355eb7b9996 58930-012 HUMAN OTC DRUG A.H.C. C-CREAM Niacinamide CREAM TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE 1 g/50mL N 20181231 58930-013_97b01aca-8bfd-4f24-96ff-6b61ea6f7308 58930-013 HUMAN OTC DRUG A.H.C. C-TONER Niacinamide LIQUID TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE 2.4 g/120mL E 20171231 58930-014_c5bd013a-ec1c-4f15-ad48-59a6e6c75224 58930-014 HUMAN OTC DRUG A.H.C. COMPLETE CHOICE liftox Cream TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd TITANIUM DIOXIDE; ZINC OXIDE 1.435; 686 g/35mL; mg/35mL E 20171231 58930-015_9be09393-b2ea-4c61-b45a-9e90586c00e5 58930-015 HUMAN OTC DRUG A.H.C. COMPLETE CHOICE Moisture Cream ETHYLHEXYL METHOXYCINNAMATE, TITANUIM DIOXIDE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHAN CREAM TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; TITANIUM DIOXIDE; OCTOCRYLENE; AVOBENZONE 2.62; 1.085; .7; .42 g/35mL; g/35mL; g/35mL; g/35mL N 20181231 58930-016_f75af596-5915-4e4e-90a2-c326b2333a9f 58930-016 HUMAN OTC DRUG A.H.C. COMPLETE CHOICE Color Change Cream ETHYLHEXYL METHOXYCINNAMATE, TITANUIM DIOXIDE, ETHYLHEXYL SALICYTLATE, ZINC OXIDE CREAM TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE 2.62; 2.14; 1.75; 1.715 g/35mL; g/35mL; g/35mL; g/35mL N 20181231 58930-017_ecba909e-62e9-47d5-b40d-be75e6e3f5ca 58930-017 HUMAN OTC DRUG COMPLETE CHOICE Moisture Amploule Adenosine LIQUID TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 6 mg/15mL E 20171231 58930-018_087d7941-9175-484e-add4-d29bbcaca757 58930-018 HUMAN OTC DRUG Supreme Shield Octinoxate, Octocrylene, Zinc Oxide AEROSOL, SPRAY TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1.68; 1.2; .576 g/80mL; g/80mL; g/80mL E 20171231 58930-019_7b4e6150-1dc8-4b71-9fd8-c00cf7dd02d8 58930-019 HUMAN OTC DRUG Supreme Shield Octinoxate, Octocrylene, Zinc Oxide AEROSOL, SPRAY TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1.68; 1.2; .576 g/80mL; g/80mL; g/80mL E 20171231 58930-020_a0546a7f-8e75-4ada-a290-9c0b6d058a20 58930-020 HUMAN OTC DRUG Supreme Shield Octinoxate, Octocrylene, Zinc Oxide AEROSOL, SPRAY TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 1.68; 1.2; .576 g/80mL; g/80mL; g/80mL E 20171231 58930-021_7e19c0a8-cafe-4619-88e6-dead8324cf16 58930-021 HUMAN OTC DRUG AHC Intense Contour Balm Titanium Dioxide CREAM TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd. TITANIUM DIOXIDE 2.46 g/30mL E 20171231 58930-022_4003ab97-852f-4e0a-a790-31926a06eda1 58930-022 HUMAN OTC DRUG AHC Intense Contour Balm Light Titanium Dioxide CREAM TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd. TITANIUM DIOXIDE 2.46 g/30mL E 20171231 58930-023_0529200a-5eac-42c0-906c-fa40da49a88e 58930-023 HUMAN OTC DRUG AHC Intense Contour Balm Moisture Methylhexy Methoxycinnamate CREAM TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd. OCTINOXATE .9 g/30mL E 20171231 58930-035_35f1e2ec-dd69-4945-b858-0dbcec0b0559 58930-035 HUMAN OTC DRUG Capture Collagen Ampoule Niacinamide 2%, Adenosine 0.04% LIQUID TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE; ADENOSINE 2; 20 g/50mL; mg/50mL E 20171231 58930-036_ced690fe-268d-43dc-8ed1-c4652ceaad05 58930-036 HUMAN OTC DRUG Capture C-Brightening Ampoule Niacinamide 2% LIQUID TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE 2 g/50mL E 20171231 58930-037_e5c5168e-859d-451c-962e-f58c1fd7c19d 58930-037 HUMAN OTC DRUG Capture Hyaluronic Ampoule Adenosine 0.04% LIQUID TOPICAL 20130705 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 20 mg/50mL E 20171231 58930-038_b63f45a6-b8ce-4ee1-90f9-ea0c5ad88045 58930-038 HUMAN OTC DRUG A.H.C. Collagen Cream Adenosine 0.04% CREAM TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 20 mg/50mL E 20171231 58930-039_8a121ba6-966e-4222-b048-f63f92956ed0 58930-039 HUMAN OTC DRUG A.H.C. Collagen Toner Adenosine 0.04% LIQUID TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 48 mg/120mL E 20171231 58930-040_b31638d3-4dd9-4831-bc8f-b51f96c7cd7f 58930-040 HUMAN OTC DRUG AHC Vital Complex C-15 Ampoule Arbutin 2%, Adenosine 0.04% LIQUID TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ARBUTIN; ADENOSINE .6; 12 g/30mL; mg/30mL E 20171231 58930-041_8c6bed2b-098c-454b-a71a-1d9e393b334a 58930-041 HUMAN OTC DRUG AHC Phyto Complex Gel Ampoule Arbutin 2% LIQUID TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ARBUTIN .6 g/30mL E 20171231 58930-042_fe48f877-02a0-4fdd-9994-a4988a3d7d40 58930-042 HUMAN OTC DRUG AHC Collagen Serum Adenosine 0.04% LIQUID TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 12 mg/30mL E 20171231 58930-043_4c29a92e-f6be-44e2-811f-92f5123ab78d 58930-043 HUMAN OTC DRUG AHC Vital C Complex Mask Niacinamide 2% LIQUID TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd NIACINAMIDE .6 g/30g E 20171231 58930-044_a4c0262f-9880-4002-9151-ff8321ce283c 58930-044 HUMAN OTC DRUG AHC Vital C Complex Mask Adenosine 0.04% LIQUID TOPICAL 20130815 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 12 mg/30g E 20171231 58930-060_b8b15312-ad3c-47bb-be2d-e76cad5ad5af 58930-060 HUMAN OTC DRUG UV Capture Sebum Control Sun Cream ETHYLHEXYL METHOXYCINNAMATE, Zinc Oxide, Ethylhexy Salicate, TITANUIM DIOXIDE, Bis-ethylhexyloxyphenol methoxyphenyl triazine CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; ZINC OXIDE; 2-ETHYLHEXYL BENZOATE; TITANIUM DIOXIDE; BEMOTRIZINOL 3.4; 2.5; 2.25; 2.15; .25 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL E 20171231 58930-060_fde0d994-6444-418d-95fe-c0dc773530be 58930-060 HUMAN OTC DRUG UV Capture Sebum Control Sun Cream ETHYLHEXYL METHOXYCINNAMATE, Zinc Oxide, Ethylhexy Salicate, TITANUIM DIOXIDE, Bis-ethylhexyloxyphenol methoxyphenyl triazine CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; ZINC OXIDE; 2-ETHYLHEXYL BENZOATE; TITANIUM DIOXIDE; BEMOTRIZINOL 3.4; 2.5; 2.25; 2.15; .25 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL E 20171231 58930-061_3f316da8-8301-48e7-804f-81c0c2212fd1 58930-061 HUMAN OTC DRUG UV Capture Vita Sun Gel Ethylhexyl methoxycinnamate, Ethylhexy Salicate, Butyl Methoxydibezoylmethane GEL TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; 2-ETHYLHEXYL BENZOATE; AVOBENZONE 3.5; 2.25; 1.5 g/50mL; g/50mL; g/50mL E 20171231 58930-061_c6f5c96b-8611-4a74-a9e7-db4bdfe72cae 58930-061 HUMAN OTC DRUG UV Capture Vita Sun Gel Ethylhexyl methoxycinnamate, Ethylhexy Salicate, Butyl Methoxydibezoylmethane GEL TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; 2-ETHYLHEXYL BENZOATE; AVOBENZONE 3.5; 2.25; 1.5 g/50mL; g/50mL; g/50mL E 20171231 58930-062_27cd19e8-be65-4ce2-81fb-163a13a3d969 58930-062 HUMAN OTC DRUG UV Capture Sun BB Titnium Dioxide, Ethylhexyl Methoxycinnamate, Zinc Oxide CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.37; .9; .57 g/30mL; g/30mL; g/30mL E 20171231 58930-062_9c6cf4d9-a69d-45d2-a050-3f84d8e58852 58930-062 HUMAN OTC DRUG UV Capture Sun BB Titnium Dioxide, Ethylhexyl Methoxycinnamate, Zinc Oxide CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.37; .9; .57 g/30mL; g/30mL; g/30mL E 20171231 58930-063_21276566-87ec-4f87-a2c9-ae09f0d15de1 58930-063 HUMAN OTC DRUG UV Capture Water Zero Sunspray Ethylhexyl methoxycinnamate, Zinc Oxide, Titanium Dioxide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine SPRAY TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE; BEMOTRIZINOL 17.5; 12.25; 10.25; 3.75 g/250mL; g/250mL; g/250mL; g/250mL E 20171231 58930-063_48411540-fc74-45da-9057-daf0cc8748e9 58930-063 HUMAN OTC DRUG UV Capture Water Zero Sunspray Ethylhexyl methoxycinnamate, Zinc Oxide, Titanium Dioxide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine SPRAY TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE; BEMOTRIZINOL 17.5; 12.25; 10.25; 3.75 g/250mL; g/250mL; g/250mL; g/250mL E 20171231 58930-064_597a6a8a-2252-459a-8d60-64e980039a99 58930-064 HUMAN OTC DRUG UV Capture Sun Pact Titnium Dioxide, Ethylhexyl Methoxycinnamate, Octocrylene POWDER TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE .8; .3; .09 g/10g; g/10g; g/10g E 20171231 58930-064_834e650a-15a9-40ac-92a3-b7c43e366b88 58930-064 HUMAN OTC DRUG UV Capture Sun Pact Titnium Dioxide, Ethylhexyl Methoxycinnamate, Octocrylene POWDER TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE .8; .3; .09 g/10g; g/10g; g/10g E 20171231 58930-065_b9aa6a05-2925-464b-887f-01e4c7d6d027 58930-065 HUMAN OTC DRUG UV Capture Sun Pact Titnium Dioxide, Ethylhexyl Methoxycinnamate, Octocrylene POWDER TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE .8; .3; .09 g/10g; g/10g; g/10g E 20171231 58930-067_3f50f402-4768-6234-e054-00144ff88e88 58930-067 HUMAN OTC DRUG AHC Phyto Complex Mask Adenosine 0.04% LIQUID TOPICAL 20161020 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd ADENOSINE 12 mg/30g N 20181231 58930-100_97a2fcd3-3eab-4497-89b1-9983a24732ac 58930-100 HUMAN OTC DRUG AHC RADIANCE GOMMAGE PEELING Allantoin, Panthenol GEL TOPICAL 20170510 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd. ALLANTOIN; PANTHENOL 1; 1 g/100mL; g/100mL N 20181231 58930-101_644a36f1-3b2d-43fc-95e4-634346c59b6f 58930-101 HUMAN OTC DRUG AHC THE REAL EYE FOR FACE Dimethicone CREAM TOPICAL 20170510 OTC MONOGRAPH FINAL part347 Carver Korea Co.,Ltd. DIMETHICONE .9 g/30mL N 20181231 58930-102_12140bf7-ea04-470f-9173-75f6903a3c82 58930-102 HUMAN OTC DRUG AHC HYDRA B5 SOOTHER Panthenol LIQUID TOPICAL 20170512 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd. PANTHENOL .5 g/50mL N 20181231 58930-103_f8ff0f02-56ec-4168-bbf5-dac6cfd859d5 58930-103 HUMAN OTC DRUG AHC PREMIUM VITAL C COMPLEX CELLULOSE MASK Niacinamide PATCH TOPICAL 20170512 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd. NIACINAMIDE .54 g/27mL N 20181231 58930-104_26551445-7901-4192-8f5d-f571987b059e 58930-104 HUMAN OTC DRUG AHC PREMIUM HYDRA SOOTHER CELLULOSE MASK Panthenol PATCH TOPICAL 20170518 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd. PANTHENOL .081 g/27mL N 20181231 58930-105_5992b7a6-e1ac-30f6-e053-2991aa0a9a8e 58930-105 HUMAN OTC DRUG A.H.C COTTON 100 MASK SKIN CERAMIDE Niacinamide, Allantoin, Adenosine PATCH TOPICAL 20170905 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd. ALLANTOIN; NIACINAMIDE; ADENOSINE .025; .05; .01 g/25mL; g/25mL; g/25mL N 20181231 58930-106_587a7abc-841f-3977-e053-2a91aa0aefd9 58930-106 HUMAN OTC DRUG A.H.C COTTON 100 MASK SOY ISOFLAVONE Niacinamide, Allantoin, Adenosine PATCH TOPICAL 20170914 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd. NIACINAMIDE; ADENOSINE; ALLANTOIN .05; .01; .025 g/25mL; g/25mL; g/25mL N 20181231 58930-108_59abc9e3-b776-680a-e053-2991aa0aa94d 58930-108 HUMAN OTC DRUG A.H.C COTTON 100 MASK MULTI PEPTIDE Niacinamide, Allantoin, Adenosine PATCH TOPICAL 20170920 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd. ALLANTOIN; ADENOSINE; NIACINAMIDE .025; .01; .05 g/25mL; g/25mL; g/25mL N 20181231 58930-109_61489379-56ab-9e0b-e053-2a91aa0aa305 58930-109 HUMAN OTC DRUG A.H.C NATURAL PLUS SUN Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate STICK TOPICAL 20170921 OTC MONOGRAPH NOT FINAL part352 Carver Korea Co.,Ltd. OCTOCRYLENE; OCTISALATE; OCTINOXATE 1.6; 1; 1.4 g/20g; g/20g; g/20g N 20181231 58930-110_59ae836d-3d65-62f0-e053-2a91aa0a8fb9 58930-110 HUMAN OTC DRUG A.H.C COTTON 100 MASK TRIPLE HYALURONIC Niacinamide, Allantoin, Adenosine PATCH TOPICAL 20170920 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd. NIACINAMIDE; ADENOSINE; ALLANTOIN .05; .01; .025 g/25mL; g/25mL; g/25mL N 20181231 58930-111_c2f291cf-a745-4098-a448-7912ca43afdd 58930-111 HUMAN OTC DRUG AHC HYDRA B5 SOOTHER (RED) Panthenol LIQUID TOPICAL 20170512 UNAPPROVED DRUG OTHER Carver Korea Co.,Ltd. PANTHENOL .5 g/50mL N 20181231 58930-112_0e098602-2375-46cd-8b6f-7303d1624389 58930-112 HUMAN OTC DRUG AHC THE REAL EYE FOR FACE (RED) Dimethicone CREAM TOPICAL 20170510 OTC MONOGRAPH FINAL part347 Carver Korea Co.,Ltd. DIMETHICONE .9 g/30mL N 20181231 58933-005_5a07c282-af28-4d41-e053-2991aa0ab9a4 58933-005 HUMAN OTC DRUG Crest Cavity Protection Regular Sodium Fluoride PASTE, DENTIFRICE DENTAL 20150201 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufactura, S. de R.L. de C.V. SODIUM FLUORIDE 1.5 mg/g N 20181231 58933-008_5a0760ea-105d-fd62-e053-2991aa0a4855 58933-008 HUMAN OTC DRUG Crest Tartar Protection Sodium Fluoride PASTE, DENTIFRICE DENTAL 19921106 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufactura, S. de R.L. de C.V. SODIUM FLUORIDE 1.5 mg/g N 20181231 58933-009_597b01a5-b187-6948-e053-2991aa0aab70 58933-009 HUMAN OTC DRUG Crest Tartar Protection Fresh Mint Gel Sodium Fluoride GEL, DENTIFRICE DENTAL 19950616 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufactura, S. de R.L. de C.V. SODIUM FLUORIDE 1.5 mg/g N 20181231 58933-020_598d5dc0-1e98-2aa4-e053-2991aa0a3c23 58933-020 HUMAN OTC DRUG Crest Complete Multi-Benefit Whitening plus Scope Sodium fluoride PASTE, DENTIFRICE DENTAL 20110701 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufactura, S. de R.L. de C.V. SODIUM FLUORIDE 1.5 mg/g N 20181231 58933-049_5a2baa54-663e-3bd0-e053-2a91aa0a5f89 58933-049 HUMAN OTC DRUG Kids Crest Cavity Protection Sparkle Fun Sodium Fluoride PASTE, DENTIFRICE DENTAL 20020905 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufactura, S. de R.L. de C.V. SODIUM FLUORIDE 1.5 mg/g N 20181231 58933-478_632859ae-ef14-2d26-e053-2a91aa0a557a 58933-478 HUMAN OTC DRUG Pepto-Bismol ULTRA Bismuth subsalicylate TABLET ORAL 20180201 OTC MONOGRAPH FINAL part335 Procter & Gamble Manufactura, S. de R.L. de C.V. BISMUTH SUBSALICYLATE 525 mg/1 N 20191231 58933-673_5a2e8849-cc84-4d75-e053-2991aa0a8646 58933-673 HUMAN OTC DRUG Crest Pro-Health Stages Sodium Fluoride PASTE, DENTIFRICE DENTAL 20080801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufactura, S. de R.L. de C.V. SODIUM FLUORIDE 1.5 mg/g N 20181231 58933-674_5a2f4f17-91ec-2a8a-e053-2a91aa0aabf8 58933-674 HUMAN OTC DRUG Crest Pro-Health Stages Sodium Fluoride PASTE, DENTIFRICE DENTAL 20080801 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufactura, S. de R.L. de C.V. SODIUM FLUORIDE 1.5 mg/g N 20181231 58933-868_5a1bb1fb-12a6-5fd1-e053-2991aa0a628b 58933-868 HUMAN OTC DRUG Crest Fresh and White Sodium Fluoride PASTE, DENTIFRICE DENTAL 20150309 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufactura, S. de R.L. de C.V. SODIUM FLUORIDE 1.5 mg/g N 20181231 58933-878_38a3ed2f-4741-585b-e054-00144ff8d46c 58933-878 HUMAN OTC DRUG Crest 3D White Radiant Mint Sodium Fluoride PASTE, DENTIFRICE DENTAL 20160704 OTC MONOGRAPH FINAL part355 Procter & Gamble Manufactura, S. de R.L. de C.V. SODIUM FLUORIDE 1.5 mg/g N 20181231 58948-1001_14870feb-bce3-4fe2-8ebf-19dea7add407 58948-1001 HUMAN OTC DRUG Instant Hand Sanitizer KickPrints ETHYL ALCOHOL GEL TOPICAL 20130618 OTC MONOGRAPH NOT FINAL part333E Empire Stationery Distributors Inc. ALCOHOL 62 mL/100mL N 20181231 58962-001_37c0bbc8-8785-4181-a636-177c7e4f9eba 58962-001 HUMAN OTC DRUG Tyra Tech Naturals Lice Treatment SODIUM CHLORIDE AEROSOL, FOAM TOPICAL 20130816 UNAPPROVED HOMEOPATHIC Tyra Tech, Inc. SODIUM CHLORIDE 2 [hp_X]/mL N 20181231 58962-002_507269c2-8fce-4934-8b81-f8574a8e7278 58962-002 HUMAN OTC DRUG Vamousse Lice Treatment Sodium Chloride AEROSOL, FOAM TOPICAL 20140224 UNAPPROVED HOMEOPATHIC Tyra Tech, Inc. SODIUM CHLORIDE 2 [hp_X]/mL N 20181231 58962-003_7c915676-d20d-433c-b046-7f56647fc0e9 58962-003 HUMAN OTC DRUG Vamousse Lice Prevention SODIUM CHLORIDE SHAMPOO TOPICAL 20140116 UNAPPROVED HOMEOPATHIC TyraTech, Inc. SODIUM CHLORIDE 1 [hp_X]/mL E 20171231 58962-004_c9ea6c90-048c-43ae-8ede-a7d541b612ec 58962-004 HUMAN OTC DRUG Vamousse Lice Protection EUCALYPTUS GLOBULUS LEAF and SODIUM CHLORIDE SHAMPOO TOPICAL 20160429 UNAPPROVED HOMEOPATHIC TyraTech, Inc. EUCALYPTUS GLOBULUS LEAF; SODIUM CHLORIDE 2; 2 [hp_X]/mL; [hp_X]/mL N 20181231 58962-005_852be3cf-c8e5-4bdd-a8f2-3f1da4c2b72c 58962-005 HUMAN OTC DRUG Vamousse Lice Defense EUCALYPTUS GLOBULUS LEAF and SODIUM CHLORIDE LOTION/SHAMPOO TOPICAL 20150930 UNAPPROVED HOMEOPATHIC Tyra Tech, Inc. EUCALYPTUS GLOBULUS LEAF; SODIUM CHLORIDE 2; 2 [hp_X]/mL; [hp_X]/mL N 20181231 58962-010_30952fd3-fc37-4332-af58-0dca8945ee61 58962-010 HUMAN OTC DRUG Vamousse Pro Lice Treatment SODIUM CHLORIDE LIQUID TOPICAL 20150925 UNAPPROVED HOMEOPATHIC Tyra Tech, Inc. SODIUM CHLORIDE 2 [hp_X]/mL N 20181231 58964-101_6ee504e2-2477-4f12-89e5-77c500e52eb6 58964-101 HUMAN OTC DRUG BEEPROPOLIS Sodium monofluorophosphate PASTE, DENTIFRICE ORAL 20130701 OTC MONOGRAPH FINAL part355 Sinhwa Life Health Co Ltd SODIUM MONOFLUOROPHOSPHATE 100 mg/100g E 20171231 58968-0001_96736ec5-5c25-4781-a2bf-88ba4fc52caa 58968-0001 HUMAN OTC DRUG VITANYA FREQUENCY DROPS NOT APPLICABLE LIQUID ORAL 20141030 UNAPPROVED HOMEOPATHIC Think Healthy Enterprises, LLC. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; TRIFOLIUM PRATENSE FLOWER; CALCIUM IODIDE; POTASSIUM CHLORIDE; NITRIC ACID; PHOSPHORIC ACID; SULFUR IODIDE 3; 3; 3; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 58975-022_01043c5c-934e-4074-9540-156ef4324e24 58975-022 HUMAN OTC DRUG YINCHIAO ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE TABLET, FILM COATED ORAL 20110216 OTC MONOGRAPH FINAL part341 TIANJIN ZHONGXIN PHARMACEUTICAL GROUP CORP LTD LONGSHUNRONG PHARMACEUTICAL FACTORY ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 162.5; 1 mg/1; mg/1 E 20171231 58977-001_87c40f6e-fd23-432e-8e61-8d404054c820 58977-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19980101 UNAPPROVED MEDICAL GAS Rice Home Medical LLC OXYGEN 99 L/100L E 20171231 58980-011_1cf8acdd-1334-48b0-9f6e-7c8149bfdd5d 58980-011 HUMAN OTC DRUG BACITRACIN ZINC BACITRACIN ZINC OINTMENT TOPICAL 20170915 OTC MONOGRAPH FINAL part333B STRATUS PHARMACEUTICALS INC BACITRACIN ZINC 500 [USP'U]/g N 20181231 58980-012_21b9442a-0c69-42c1-ba5b-e7a2101780c4 58980-012 HUMAN OTC DRUG BACITRACIN ZINC BACITRACIN ZINC and POLYMYXIN B SULFATE OINTMENT TOPICAL 20170915 OTC MONOGRAPH FINAL part333B STRATUS PHARMACEUTICALS INC BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 58980-155_e59ac43a-78ff-4d34-9865-5f5b617045cb 58980-155 HUMAN OTC DRUG Hypercare Aluminum Chloride SOLUTION TOPICAL 20160127 OTC MONOGRAPH FINAL part350 Stratus Pharmaceuticals ALUMINUM CHLORIDE 15 g/100mL N 20181231 58980-409_b37fb17f-3b60-4fe2-bf67-fc8b6b721fba 58980-409 HUMAN OTC DRUG Stratuscare Glycerin Laxative Pediatric Glycerin SUPPOSITORY RECTAL 20140601 OTC MONOGRAPH NOT FINAL part334 Stratus Pharmaceuticals GLYCERIN 1 g/1 E 20171231 58980-410_8ed41118-4f7c-463e-9060-d668fc9b9174 58980-410 HUMAN OTC DRUG Stratuscare Adult Glycerin Glycerin SUPPOSITORY RECTAL 20140530 OTC MONOGRAPH NOT FINAL part334 Stratus Pharmaceuticals GLYCERIN 2 g/1 E 20171231 58980-415_3b25df6c-a937-4956-9435-5c41b66c3ef9 58980-415 HUMAN OTC DRUG Stratuscare Bisacodyl Bisacodyl SUPPOSITORY RECTAL 20140530 OTC MONOGRAPH NOT FINAL part334 Stratus Pharmaceuticals BISACODYL 10 mg/1 E 20171231 58980-615_86a1aae9-7df2-4dd4-9053-11665c4b99bd 58980-615 HUMAN OTC DRUG ARCTIC RELIEF MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20170915 OTC MONOGRAPH FINAL part341 STRATUS PHARMACEUTICALS INC MENTHOL, UNSPECIFIED FORM 3.969 g/113.4g N 20181231 58980-617_3dbca047-fc59-41a1-a742-832f889bb4ce 58980-617 HUMAN OTC DRUG ARCTIC RELIEF ROLL ON MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20170915 OTC MONOGRAPH FINAL part341 STRATUS PHARMACEUTICALS INC MENTHOL, UNSPECIFIED FORM 3.969 g/90g N 20181231 58980-780_ae718f2b-8848-4f0c-b556-1561a3524c8f 58980-780 HUMAN PRESCRIPTION DRUG Venelex Castor Oil and Balsam, Peru OINTMENT TOPICAL 20091129 UNAPPROVED DRUG OTHER Stratus Pharamceuticals, Inc CASTOR OIL; BALSAM, PERU 788; 87 mg/g; mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 58980-811_d2a1eae3-0499-46fd-ad6e-fa7102c67519 58980-811 HUMAN PRESCRIPTION DRUG Dermazene hydrocortisone and Iodoquinol CREAM TOPICAL 20010611 UNAPPROVED DRUG OTHER Stratus Pharamceuticals, Inc HYDROCORTISONE; IODOQUINOL 10; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 58980-818_fa7abfcb-49d5-412f-88ab-68af39fd0f5d 58980-818 HUMAN OTC DRUG Azolen Miconazole Nitrate TINCTURE TOPICAL 20170915 OTC MONOGRAPH FINAL part333C Stratus Pharmaceuticals, Inc. MICONAZOLE NITRATE 20 mg/mL N 20181231 58980-820_d61f6260-2eae-4911-a499-8bc12abf0b6d 58980-820 HUMAN OTC DRUG Castellani Paint Phenol LIQUID TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Stratus Pharamceuticals PHENOL 15 mg/mL N 20181231 58980-822_adb7a8f8-57b9-426c-a1e5-6d0285d85f10 58980-822 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride LOTION TOPICAL 20120301 UNAPPROVED DRUG OTHER Stratus Pharamceuticals LIDOCAINE HYDROCHLORIDE 5.31 mL/177mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 58982-010_c98056df-159d-49f7-967e-0f43cd9af8d9 58982-010 HUMAN OTC DRUG OZ TREE HandMade by Dorothy Allantoin SOAP TOPICAL 20130701 OTC MONOGRAPH FINAL part347 OZ SOAP TREE ALLANTOIN .55 g/110g E 20171231 58986-010_1ee904da-8395-489b-86b1-e1450edf5162 58986-010 HUMAN OTC DRUG FUCOIDAN SKINCURE Allantoin SPRAY TOPICAL 20130601 OTC MONOGRAPH FINAL part347 SAMDAONE ALLANTOIN 1.2 g/100g E 20171231 58986-020_0a9c143b-eddc-44ed-a7da-452dc470a14b 58986-020 HUMAN OTC DRUG FUCOIDAN ESSENCE Allantoin CREAM TOPICAL 20130601 OTC MONOGRAPH FINAL part347 SAMDAONE ALLANTOIN 1 g/50g E 20171231 58986-030_8baa8ec9-0d0b-47f3-b74f-ef5788e2eb44 58986-030 HUMAN OTC DRUG FUCOIDAN HAIR TONIC Allantoin SPRAY TOPICAL 20130601 OTC MONOGRAPH FINAL part347 SAMDAONE ALLANTOIN .3 g/60g E 20171231 58987-001_e7ce6a0d-13d7-4463-b3e2-1081dab99a46 58987-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Enos Home Oxygen Therapy, Inc. OXYGEN 99.5 L/100L N 20181231 58988-0017_0c1a9abd-4a83-5620-e054-00144ff88e88 58988-0017 HUMAN OTC DRUG Sanafitil Tolnaftate CREAM TOPICAL 20150107 OTC MONOGRAPH FINAL part333C Promex LLC TOLNAFTATE 1 g/100g E 20171231 58988-0018_de5b12b7-cb4f-483e-8a0a-baaf8d3c89f6 58988-0018 HUMAN OTC DRUG Redness reliever and Lubricant dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl LIQUID OPHTHALMIC 20131206 OTC MONOGRAPH FINAL part349 Promex, LLC TETRAHYDROZOLINE HYDROCHLORIDE; DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE .5; 1; 10; 10 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 58988-0019_553d46a8-01d6-2271-e054-00144ff88e88 58988-0019 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part348 Promex, LLC HYDROCORTISONE 1 g/100g N 20181231 58988-0022_5b99775b-1586-4fd8-9466-0ab91ac5b223 58988-0022 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20131204 OTC MONOGRAPH FINAL part333C Promex, LLC CLOTRIMAZOLE 1 g/100g E 20171231 58988-0027_0c14873c-f8a5-087a-e054-00144ff88e88 58988-0027 HUMAN OTC DRUG Sanafitil Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20140108 OTC MONOGRAPH FINAL part332 Promex LLC DIMETHICONE 125 mg/1 E 20171231 58988-0031_f1eac575-6602-4a06-a863-647497d835f0 58988-0031 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20131202 OTC MONOGRAPH FINAL part333B Promex, LLC BACITRACIN ZINC 500 [USP'U]/g E 20171231 58988-0038_3c0ddae5-1273-482b-8fa8-f8b88a99a956 58988-0038 HUMAN OTC DRUG Antibiotic Neomycin sulfate OINTMENT TOPICAL 20131205 OTC MONOGRAPH FINAL part333B Promex, LLC NEOMYCIN SULFATE 3.5 mg/g E 20171231 58988-0148_b776833e-2216-4e51-aee0-e80aa0a44ae5 58988-0148 HUMAN OTC DRUG T-RAOJO tetrahydrozoline Hydrochloride LIQUID OPHTHALMIC 20140717 OTC MONOGRAPH FINAL part349 Promex, LLC TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 58988-0184_4315aea0-67db-4a88-b6c6-2908555a997f 58988-0184 HUMAN OTC DRUG Saline Nasal Sodium chloride SPRAY NASAL 20131209 UNAPPROVED DRUG OTHER Promex, LLC SODIUM CHLORIDE 6.5 mg/mL N 20181231 58988-0193_6b63b9a2-bc68-4472-a3d3-d973e4c28aec 58988-0193 HUMAN OTC DRUG Nasal Decongestant Oxymetazoline HCl SPRAY NASAL 20131209 OTC MONOGRAPH FINAL part341 Promex, LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL E 20171231 58988-1080_b82ac060-39b9-4a1c-97f4-e6930fe03b74 58988-1080 HUMAN OTC DRUG Estomaquil Polvo BISMUTH SUBSALICYLATE POWDER ORAL 20040102 OTC MONOGRAPH FINAL part335 ProMex LLC BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 58988-1100_c33f04d2-4993-41a4-bb70-4134011c7555 58988-1100 HUMAN OTC DRUG OIDO SANA ISOPROPYL ALCOHOL SOLUTION AURICULAR (OTIC) 20060531 OTC MONOGRAPH FINAL part344 ProMex LLC ISOPROPYL ALCOHOL .95 g/mL N 20181231 58988-1170_a86c3161-5870-4431-a78e-3eed4a004fe7 58988-1170 HUMAN OTC DRUG Cuadriderma Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, and PRAMOXINE HYDROCHLORIDE OINTMENT TOPICAL 20130531 OTC MONOGRAPH FINAL part333B ProMex LLC BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE 500; 10000; 3.5; 10 [iU]/g; [iU]/g; mg/g; mg/g N 20181231 58988-1600_0c3c9fdd-9fc7-6c8a-e054-00144ff88e88 58988-1600 HUMAN OTC DRUG Sanafitil Crema Tolnaftate CREAM TOPICAL 20150107 OTC MONOGRAPH FINAL part333C Promex LLC TOLNAFTATE 1 g/100g E 20171231 58988-1760_590596c7-cde5-419a-b5d2-759b8d996fba 58988-1760 HUMAN OTC DRUG Pyrantel Pamoate Pyrantel Pamoate TABLET ORAL 20020927 OTC MONOGRAPH FINAL part357B ProMex LLC PYRANTEL PAMOATE 180 mg/1 N 20191231 58988-1770_3be9455a-924e-48d3-af32-f1f5a41b3526 58988-1770 HUMAN OTC DRUG Pyrantel Pamoate Pyrantel Pamoate SUSPENSION ORAL 20020927 OTC MONOGRAPH FINAL part357B ProMex LLC PYRANTEL PAMOATE 144 mg/mL N 20191231 58988-1800_0c3cb08c-301f-71f1-e054-00144ff8d46c 58988-1800 HUMAN OTC DRUG Estomaquil Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20140108 OTC MONOGRAPH FINAL part332 Promex LLC DIMETHICONE 125 mg/1 E 20171231 58990-000_733391bf-a753-4a09-9e20-a881a7f16368 58990-000 HUMAN OTC DRUG Antiac Acne Clearing Salicylic Acid SPRAY TOPICAL 20130713 OTC MONOGRAPH FINAL part333D Salcura Ltd SALICYLIC ACID 5 mg/mL E 20171231 59011-255_e6069acd-fd6f-4229-a71a-7258a2a35587 59011-255 HUMAN PRESCRIPTION DRUG Intermezzo zolpidem tartrate TABLET SUBLINGUAL 20120405 NDA NDA022328 Purdue Pharma LP ZOLPIDEM TARTRATE 3.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 59011-256_e6069acd-fd6f-4229-a71a-7258a2a35587 59011-256 HUMAN PRESCRIPTION DRUG Intermezzo zolpidem tartrate TABLET SUBLINGUAL 20120405 NDA NDA022328 Purdue Pharma LP ZOLPIDEM TARTRATE 1.75 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 59011-260_7132048d-6d8b-ad24-09ad-1d2d8c7e727e 59011-260 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Purdue Pharma LP MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-261_7132048d-6d8b-ad24-09ad-1d2d8c7e727e 59011-261 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Purdue Pharma LP MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-262_7132048d-6d8b-ad24-09ad-1d2d8c7e727e 59011-262 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Purdue Pharma LP MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-263_7132048d-6d8b-ad24-09ad-1d2d8c7e727e 59011-263 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Purdue Pharma LP MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-264_7132048d-6d8b-ad24-09ad-1d2d8c7e727e 59011-264 HUMAN PRESCRIPTION DRUG MS Contin morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870701 NDA NDA019516 Purdue Pharma LP MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-271_5ae3a057-7eb3-4166-8f76-3cf8d910ca9d 59011-271 HUMAN PRESCRIPTION DRUG Hysingla ER hydrocodone bitartrate TABLET, EXTENDED RELEASE ORAL 20150115 NDA NDA206627 Purdue Pharma LP HYDROCODONE BITARTRATE 20 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 59011-272_5ae3a057-7eb3-4166-8f76-3cf8d910ca9d 59011-272 HUMAN PRESCRIPTION DRUG Hysingla ER hydrocodone bitartrate TABLET, EXTENDED RELEASE ORAL 20150115 NDA NDA206627 Purdue Pharma LP HYDROCODONE BITARTRATE 30 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 59011-273_5ae3a057-7eb3-4166-8f76-3cf8d910ca9d 59011-273 HUMAN PRESCRIPTION DRUG Hysingla ER hydrocodone bitartrate TABLET, EXTENDED RELEASE ORAL 20150115 NDA NDA206627 Purdue Pharma LP HYDROCODONE BITARTRATE 40 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 59011-274_5ae3a057-7eb3-4166-8f76-3cf8d910ca9d 59011-274 HUMAN PRESCRIPTION DRUG Hysingla ER hydrocodone bitartrate TABLET, EXTENDED RELEASE ORAL 20150115 NDA NDA206627 Purdue Pharma LP HYDROCODONE BITARTRATE 60 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 59011-275_5ae3a057-7eb3-4166-8f76-3cf8d910ca9d 59011-275 HUMAN PRESCRIPTION DRUG Hysingla ER hydrocodone bitartrate TABLET, EXTENDED RELEASE ORAL 20150115 NDA NDA206627 Purdue Pharma LP HYDROCODONE BITARTRATE 80 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 59011-276_5ae3a057-7eb3-4166-8f76-3cf8d910ca9d 59011-276 HUMAN PRESCRIPTION DRUG Hysingla ER hydrocodone bitartrate TABLET, EXTENDED RELEASE ORAL 20150115 NDA NDA206627 Purdue Pharma LP HYDROCODONE BITARTRATE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 59011-277_5ae3a057-7eb3-4166-8f76-3cf8d910ca9d 59011-277 HUMAN PRESCRIPTION DRUG Hysingla ER hydrocodone bitartrate TABLET, EXTENDED RELEASE ORAL 20150115 NDA NDA206627 Purdue Pharma LP HYDROCODONE BITARTRATE 120 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 59011-410_7878ad7b-5d64-40e9-af0e-a366c5b17849 59011-410 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-415_7878ad7b-5d64-40e9-af0e-a366c5b17849 59011-415 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-420_7878ad7b-5d64-40e9-af0e-a366c5b17849 59011-420 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-430_7878ad7b-5d64-40e9-af0e-a366c5b17849 59011-430 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-440_7878ad7b-5d64-40e9-af0e-a366c5b17849 59011-440 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-442_182d5b8e-6145-60ab-a2ec-a188aa83eb98 59011-442 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19260101 NDA NDA019034 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-444_182d5b8e-6145-60ab-a2ec-a188aa83eb98 59011-444 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19260101 NDA NDA019034 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-451_0cc002bd-a7e7-0cd0-bf27-678460984ad5 59011-451 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE LIQUID ORAL 19560101 NDA NDA019891 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-452_0cc002bd-a7e7-0cd0-bf27-678460984ad5 59011-452 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 19560101 NDA NDA019892 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-454_0cc002bd-a7e7-0cd0-bf27-678460984ad5 59011-454 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 19560101 NDA NDA019892 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-458_0cc002bd-a7e7-0cd0-bf27-678460984ad5 59011-458 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 19560101 NDA NDA019892 Purdue Pharma LP HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-460_7878ad7b-5d64-40e9-af0e-a366c5b17849 59011-460 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-480_7878ad7b-5d64-40e9-af0e-a366c5b17849 59011-480 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Purdue Pharma LP OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 59011-523_0b82784a-f477-4107-9e4a-a1490a603262 59011-523 HUMAN PRESCRIPTION DRUG Symproic naldemedine TABLET ORAL 20170323 NDA NDA208854 Purdue Pharma LP NALDEMEDINE TOSYLATE .2 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 59011-750_11998211-233a-4914-95ad-90484adac7a1 59011-750 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20110214 NDA NDA021306 Purdue Pharma LP BUPRENORPHINE 5 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 59011-751_11998211-233a-4914-95ad-90484adac7a1 59011-751 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20110214 NDA NDA021306 Purdue Pharma LP BUPRENORPHINE 10 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 59011-752_11998211-233a-4914-95ad-90484adac7a1 59011-752 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20110214 NDA NDA021306 Purdue Pharma LP BUPRENORPHINE 20 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 59011-757_11998211-233a-4914-95ad-90484adac7a1 59011-757 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20110214 NDA NDA021306 Purdue Pharma LP BUPRENORPHINE 7.5 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 59011-758_11998211-233a-4914-95ad-90484adac7a1 59011-758 HUMAN PRESCRIPTION DRUG Butrans buprenorphine PATCH, EXTENDED RELEASE TRANSDERMAL 20110214 NDA NDA021306 Purdue Pharma LP BUPRENORPHINE 15 ug/h Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 59021-001_87785124-51ce-40fb-aedd-192bf9c6db9a 59021-001 HUMAN OTC DRUG Candy Apple Anti Bacterial Foaming Hand TRICLOSAN LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below TRICLOSAN .3 g/100mL E 20171231 59021-002_bb2303fc-651b-413d-be86-9119e15b5cd5 59021-002 HUMAN OTC DRUG Caribbean Escape Anti Bacterial Foaming Hand TRICLOSAN LIQUID TOPICAL 20130413 OTC MONOGRAPH NOT FINAL part333E Five Below TRICLOSAN .3 g/100mL E 20171231 59021-003_1a5c07fb-e0a7-445a-97ca-8b1773631147 59021-003 HUMAN OTC DRUG Cotton Candy Anti Bacterial Foaming Hand TRICLOSAN LIQUID TOPICAL 20130413 OTC MONOGRAPH NOT FINAL part333E Five Below TRICLOSAN .3 g/100mL E 20171231 59021-004_6afdd58b-0249-4c0b-abc2-72161e5b15f0 59021-004 HUMAN OTC DRUG Mango Madness Anti Bacterial Foaming Hand TRICLOSAN LIQUID TOPICAL 20130413 OTC MONOGRAPH NOT FINAL part333E Five Below TRICLOSAN .3 g/100mL E 20171231 59021-005_4184ed08-d723-4db8-95d5-4b99dfe3ec58 59021-005 HUMAN OTC DRUG Vanilla Cupcake Anti Bacterial Foaming Hand TRICLOSAN LIQUID TOPICAL 20130413 OTC MONOGRAPH NOT FINAL part333E Five Below TRICLOSAN .3 g/100mL E 20171231 59021-006_273d0ab2-ef18-4d23-a720-f0e82137203a 59021-006 HUMAN OTC DRUG Fresh Picked Strawberries Anti Bacterial Foaming Hand TRICLOSAN LIQUID TOPICAL 20130413 OTC MONOGRAPH NOT FINAL part333E Five Below TRICLOSAN .3 g/100mL E 20171231 59021-007_acc69bf5-f86d-4999-ba3d-5539017680ab 59021-007 HUMAN OTC DRUG Fresh Picked Strawberries Anti Bacterial Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below BENZETHONIUM CHLORIDE .13 g/100mL E 20171231 59021-008_d193d79d-23bb-4403-8749-3c39d3074688 59021-008 HUMAN OTC DRUG Caribbean Escape Anti Bacterial Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below BENZETHONIUM CHLORIDE .13 g/100mL E 20171231 59021-009_e0ccaa60-e66f-4a7e-a7c2-a3a24352ce6b 59021-009 HUMAN OTC DRUG Cotton Candy Anti Bacterial Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below BENZETHONIUM CHLORIDE .13 g/100mL E 20171231 59021-010_b5938a42-57de-40da-a966-9c89ec3e5b0b 59021-010 HUMAN OTC DRUG Candy Apple Anti Bacterial Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below BENZETHONIUM CHLORIDE .13 g/100mL E 20171231 59021-011_fccd85f9-2905-4474-a560-3a54e674fe22 59021-011 HUMAN OTC DRUG Vanilla Cupcake Anti Bacterial Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below BENZETHONIUM CHLORIDE .13 g/100mL E 20171231 59021-012_f9a7e010-a0fa-4f01-88c6-64fdadf0ccb7 59021-012 HUMAN OTC DRUG Mango Madness Anti Bacterial Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130412 OTC MONOGRAPH NOT FINAL part333E Five Below BENZETHONIUM CHLORIDE .13 g/100mL E 20171231 59045-1001_9a5df0c9-d52a-441e-9b5c-05132d261900 59045-1001 HUMAN OTC DRUG Anti-Bacterial Hand Gel Apple Pie ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL N 20181231 59045-1002_1f8ebd59-2f13-4739-b5ec-72e6711f1798 59045-1002 HUMAN OTC DRUG Anti-Bacterial Hand Gel Pink Lemonade ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL N 20181231 59045-1003_d3a76b68-6259-44ec-9847-7c18c98b7f59 59045-1003 HUMAN OTC DRUG Anti-Bacterial Hand Gel Candy Apple ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL N 20181231 59045-1004_a688a6d1-099a-43db-874f-4a234e659f65 59045-1004 HUMAN OTC DRUG Anti-Bacterial Hand Gel Sweet Pea ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL N 20181231 59045-1005_28e01cef-4673-456d-944a-78dd656cb085 59045-1005 HUMAN OTC DRUG Anti-Bacterial Hand Gel Fresh Picked Strawberries ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL N 20181231 59045-1006_213952da-7173-41fa-93ea-85e94f88ad96 59045-1006 HUMAN OTC DRUG Anti-Bacterial Hand Gel Caribbean Escape ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL N 20181231 59045-1007_e745f5b7-729d-47ff-928a-4c711c7f8226 59045-1007 HUMAN OTC DRUG Anti-Bacterial Hand Gel Vanilla Cupcake ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL N 20181231 59045-1008_1b78b099-f3f2-46c4-83e9-c52dae89d329 59045-1008 HUMAN OTC DRUG Anti-Bacterial Hand Gel Mango Madness ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL N 20181231 59045-1009_6f1e71be-ba38-4605-8820-2b1f27c9f422 59045-1009 HUMAN OTC DRUG Anti-Bacterial Hand Gel Cotton Candy ETHYL ALCOHOL GEL TOPICAL 20130710 OTC MONOGRAPH NOT FINAL part333E The Man Can, LLC ALCOHOL 60 mL/100mL N 20181231 59050-242_7567d0f9-2fa4-49ba-a13e-3ae65b5e348a 59050-242 HUMAN OTC DRUG MK Alcohol Swabstick Sterile ISOPROPYL ALCOHOL LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 59050-244_37ff8dde-6a1b-47e1-9622-1aadd6e8cef4 59050-244 HUMAN OTC DRUG MK Alcohol Swabstick Sterile ISOPROPYL ALCOHOL LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 59050-257_55ef9598-0c3f-06a9-e054-00144ff8d46c 59050-257 HUMAN OTC DRUG MK Povidone-Iodine Swabstick Sterile POVIDONE-IODINE LIQUID TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd POVIDONE-IODINE 100 mg/mL N 20181231 59050-258_60e2c5ee-d4b6-9229-e053-2a91aa0a0f13 59050-258 HUMAN OTC DRUG MK Povidone Iodine Swabstick Sterile POVIDONE-IODINE PATCH TOPICAL 20170927 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd POVIDONE-IODINE 100 mg/g N 20181231 59050-331_35cb229b-3a50-230a-e054-00144ff8d46c 59050-331 HUMAN OTC DRUG MK BZK Antiseptic Towelette Non-Sterile BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59050-332_35cb2cbd-f78e-1d25-e054-00144ff8d46c 59050-332 HUMAN OTC DRUG MK BZK Antiseptic Towelette Sterile BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 59050-414_35cb2cbd-f7a0-1d25-e054-00144ff8d46c 59050-414 HUMAN OTC DRUG MK Sting Relief Pads BENZOCAINE, ISOPROPYL ALCOHOL LIQUID TOPICAL 20140609 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd BENZOCAINE; ISOPROPYL ALCOHOL 6; 60 mg/mL; mg/mL N 20181231 59050-434_4e820c7d-dcd1-4388-8db8-2583fa5a9b60 59050-434 HUMAN OTC DRUG MK BZK Swab Sterile BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59050-434_90b99635-bc9d-4173-9f33-08c8ae033eb2 59050-434 HUMAN OTC DRUG MK BZK Swab Non-Sterile BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333E Changzhou Maokang Medical Products Co., Ltd BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59050-444_35c3cfcb-2b25-4538-be29-1bbae0def269 59050-444 HUMAN OTC DRUG MK Alcohol Prep Pads Medium ISOPROPYL ALCOHOL LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 59050-444_87072da7-86bf-4d1f-8de3-c2cd0116c1fe 59050-444 HUMAN OTC DRUG MK Alcohol Prep Pads Medium ISOPROPYL ALCOHOL LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 59050-448_124daba7-e441-4c21-ad06-998de1ddf6db 59050-448 HUMAN OTC DRUG MK Alcohol Prep Pads Large ISOPROPYL ALCOHOL LIQUID TOPICAL 20140312 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 59050-448_ce80953c-6d6e-459f-8c21-45011916caa9 59050-448 HUMAN OTC DRUG MK Alcohol Prep Pads Large ISOPROPYL ALCOHOL LIQUID TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333A Changzhou Maokang Medical Products Co., Ltd ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 59051-7100_8888fc2f-f06a-44db-8f40-2036fe552136 59051-7100 HUMAN OTC DRUG Companion Hand Sanitizer hand sanitizer LIQUID TOPICAL 20170605 OTC MONOGRAPH NOT FINAL part333E Neogen Corporation ALCOHOL 338.82 g/L N 20181231 59054-000_8025c0e7-fa99-4579-8139-f3201505960c 59054-000 HUMAN OTC DRUG Academy Sports Outdoors SUNSCREEN CONTINUOUS SPORT BROAD SPECTRUM SPF 50 Water-Resistant AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130514 OTC MONOGRAPH NOT FINAL part352 Academy Ltd AVOBENZONE; OCTOCRYLENE; OXYBENZONE 30; 100; 50 mg/mL; mg/mL; mg/mL N 20181231 59054-001_501d974d-9209-4b15-b20d-a200425ce525 59054-001 HUMAN OTC DRUG Academy Sports Outdoors SUNSCREEN CONTINUOUS BROAD SPECTRUM SPF 50 Water-Resistant AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130514 OTC MONOGRAPH NOT FINAL part352 Academy Ltd AVOBENZONE; OCTOCRYLENE; OXYBENZONE 30; 100; 50 mg/mL; mg/mL; mg/mL N 20181231 59054-110_a56e42d5-8c85-4553-93c5-a0572cebe45d 59054-110 HUMAN OTC DRUG Academy Sport SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 ACADEMY, LTD AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59054-120_7bbcdb59-052d-4c5f-acc4-71843139511b 59054-120 HUMAN OTC DRUG Academy SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 ACADEMY, LTD AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59054-140_a9b2e101-4fed-4ed9-9050-ee7f20651612 59054-140 HUMAN OTC DRUG Academy Continuous SPF 50 AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 ACADEMY, LTD AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 5 g/100g; g/100g; g/100g N 20181231 59054-141_83a51487-6507-4e27-975b-7fc00e0a86fa 59054-141 HUMAN OTC DRUG Academy Continuous Sport SPF 50 AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20130827 OTC MONOGRAPH NOT FINAL part352 ACADEMY, LTD AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 10; 5 g/100g; g/100g; g/100g N 20181231 59054-370_1e15083c-59ad-4b55-a6d4-f51625e08cb4 59054-370 HUMAN OTC DRUG Academy Sport SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20130628 OTC MONOGRAPH NOT FINAL part352 ACADEMY, LTD AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g N 20181231 59054-880_42836d50-8548-4c84-be25-96b01416d489 59054-880 HUMAN OTC DRUG Academy SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20160720 OTC MONOGRAPH NOT FINAL part352 ACADEMY, LTD AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 15; 5; 1.2; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59062-1003_c310dd48-6c44-467f-a6ec-852beb7ae99e 59062-1003 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL N 20191231 59062-1005_c310dd48-6c44-467f-a6ec-852beb7ae99e 59062-1005 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL N 20191231 59062-1044_a2061017-54bf-4c7d-9bb0-c7b1c4894980 59062-1044 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL N 20191231 59062-1062_8525698c-0763-4cbc-950a-022375627b3c 59062-1062 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL N 20191231 59062-1068_8525698c-0763-4cbc-950a-022375627b3c 59062-1068 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL N 20191231 59062-1207_fcf53b45-4e13-4ecc-8b1a-ce68ca807d5d 59062-1207 HUMAN OTC DRUG BabyGanics Sunscreen 50 SPF OCTINOXATE, OCTISALATE, and ZINC OXIDE SPRAY TOPICAL 20130621 OTC MONOGRAPH NOT FINAL part352 KAS Direct LLC dba BabyGanics OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 112 mg/mL; mg/mL; mg/mL N 20191231 59062-1210_1754dcac-8f4b-4565-9d26-83db0da4d34b 59062-1210 HUMAN OTC DRUG BabyGanics Sunscreen 50SPF OCTINOXATE, OCTISALATE, and ZINC OXIDE LOTION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 KAS Direct LLC dba BabyGanics OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 117 mg/mL; mg/mL; mg/mL N 20191231 59062-1219_a450bee5-ea7f-42fc-b1c7-77d681f78210 59062-1219 HUMAN OTC DRUG BABYGANICS DIAPER RASH ZINC OXIDE CREAM TOPICAL 20130621 OTC MONOGRAPH FINAL part347 KAS Direct LLC dba BabyGanics ZINC OXIDE 150 mg/g N 20191231 59062-1227_dc22969f-fe37-4987-b20d-479be9507140 59062-1227 HUMAN OTC DRUG BabyGanics Sunscreen 30SPF TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20130621 OTC MONOGRAPH NOT FINAL part352 KAS Direct LLC dba BabyGanics TITANIUM DIOXIDE; ZINC OXIDE 30; 30 mg/mL; mg/mL N 20191231 59062-1229_d27cead8-21be-45bf-93ed-95a8afb57635 59062-1229 HUMAN OTC DRUG BabyGanics Sunscreen 30 SPF ZINC OXIDE, OCTINOXATE, and OCTISALATE SPRAY TOPICAL 20130621 OTC MONOGRAPH NOT FINAL part352 KAS Direct LLC dba BabyGanics ZINC OXIDE; OCTINOXATE; OCTISALATE 112; 50; 40 mg/mL; mg/mL; mg/mL N 20191231 59062-1238_30d67649-79aa-469e-8b9e-36e35e9904ff 59062-1238 HUMAN OTC DRUG BabyGanics Sunscreen 50SPF OCTINOXATE, OCTISALATE, and ZINC OXIDE LOTION TOPICAL 20130621 OTC MONOGRAPH NOT FINAL part352 KAS Direct LLC dba BabyGanics OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 117 mg/mL; mg/mL; mg/mL N 20191231 59062-1247_44ba4f88-a4f4-4e4c-816b-86c65b2c6cd7 59062-1247 HUMAN OTC DRUG BabyGanics Sunscreen 50SPF OCTINOXATE, OCTISALATE, and ZINC OXIDE LOTION TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 KAS Direct LLC dba BabyGanics OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 117 mg/mL; mg/mL; mg/mL N 20191231 59062-1286_af8ec19d-7856-4d22-8ea0-a5eee0b84847 59062-1286 HUMAN OTC DRUG BabyGanics Cold Relief Chest Rub MENTHOL STICK TOPICAL 20130815 OTC MONOGRAPH FINAL part341 KAS Direct LLC dba BabyGanics MENTHOL, UNSPECIFIED FORM 2.6 mg/g N 20191231 59062-1303_5cd56a02-6925-4f56-b794-2790855f38b7 59062-1303 HUMAN OTC DRUG BABYGANICS ECZEMA OATMEAL LOTION TOPICAL 20130621 OTC MONOGRAPH FINAL part347 KAS Direct LLC dba BabyGanics OATMEAL 10 mg/g N 20191231 59062-1304_6a93b92d-6eeb-4bad-bc16-dcdb81c26fc4 59062-1304 HUMAN OTC DRUG BabyGanics Bye, Bye Dry Eczema OATMEAL LOTION TOPICAL 20130621 OTC MONOGRAPH FINAL part347 KAS Direct LLC dba BabyGanics OATMEAL 10 mg/g E 20171231 59062-1327_f98e7be9-9756-4be3-826a-0a41c0d7b683 59062-1327 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL N 20191231 59062-1381_41ab9ee1-bc1d-459a-b423-954c4e566e7c 59062-1381 HUMAN OTC DRUG BabyGanics Alcohol Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333E KAS Direct LLC dba BabyGanics BENZALKONIUM CHLORIDE .1 mg/mL N 20191231 59063-127_ce4a0985-fac9-4688-9a48-0f2943bf6434 59063-127 HUMAN PRESCRIPTION DRUG Gabapentin gabapentin SOLUTION ORAL 20120501 ANDA ANDA076403 Kiel Laboratories, Inc. GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 59067-001_bdf145b2-6dca-4b43-9196-2c4ab597504a 59067-001 HUMAN OTC DRUG Emesyl Nausea Relief Ipecacuanha, Tabacum, Zingiber officinale SPRAY NASAL 20140520 UNAPPROVED HOMEOPATHIC Itonis, Inc. IPECAC; TOBACCO LEAF; GINGER 3; 3; 1 [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL E 20171231 59078-001_bc0da773-2816-4b40-a330-fd2358d156a6 59078-001 HUMAN OTC DRUG INTENSE CARE GALACTOMYCES WHITENING Titanium Dioxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE .38 mg/45mL N 20181231 59078-002_8f928989-9c0a-4058-85df-d24f7902e40f 59078-002 HUMAN OTC DRUG INTENSE CARE GALACTOMYCES WHITENING ESSENCE Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 11.57 mg/50mL N 20181231 59078-003_cff39e8b-0dd4-4a8f-b12c-6c6d2bb4ec2e 59078-003 HUMAN OTC DRUG INTENSE CARE GALACTOMYCES FIRST ESSENCE Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 31 mg/155mL N 20181231 59078-004_26651a06-a9d8-48c7-af3e-0c88f560470b 59078-004 HUMAN OTC DRUG G9 Whitening Skin ZINC OXIDE LIQUID TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. ZINC OXIDE .65 mg/130mL N 20181231 59078-005_667eed57-4c82-462c-af81-4a3e09becba6 59078-005 HUMAN OTC DRUG G9 Whitening DIMETHICONE LOTION TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE 2.4 mg/130mL N 20181231 59078-006_6a35be34-29f6-4cc2-a98d-9fe384484b64 59078-006 HUMAN OTC DRUG FLORIA WHITENING PETAL TONER Dimethicone LIQUID TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE 3.1 mg/155mL N 20181231 59078-007_4443c385-93bc-4f5a-85af-bbf6b120626e 59078-007 HUMAN OTC DRUG FLORIA WHITENING DAY SPF15 PA Plus OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 3.5; 1.28 mg/50mL; mg/50mL N 20181231 59078-008_556f890c-2999-4f03-9d57-a7f57ed612d8 59078-008 HUMAN OTC DRUG FLORIA WHITENING EMULSION Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 26 mg/130mL N 20181231 59078-009_01a3c85e-cbc3-45f8-9028-d72a9764080c 59078-009 HUMAN OTC DRUG GALACTOMYCES MAN BOOSTER Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 29 mg/145mL N 20181231 59078-010_4d8d37cd-03e8-41d6-a889-c8ae91522e2d 59078-010 HUMAN OTC DRUG Intense Care Snail Skin Glycerin LIQUID TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 28 mg/140mL N 20181231 59078-011_055dbfbb-8b29-4a0d-9439-b837fc81f2a3 59078-011 HUMAN OTC DRUG Intense Care Snail Essence Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 7 mg/35mL N 20181231 59078-012_b43cfdd9-2537-4f16-96f8-d7683ecf39d7 59078-012 HUMAN OTC DRUG Intense Care Snail Anti wrinkle Whitening Nutrition Glycerin LOTION TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 28 mg/140mL N 20181231 59078-013_a8691c5f-6225-488d-bec6-f221475506e5 59078-013 HUMAN OTC DRUG Intense Care Snail Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 9 mg/45mL N 20181231 59078-014_26d23e07-2a67-4d17-ad22-dd61c930e19f 59078-014 HUMAN OTC DRUG Intense Care Snail Eye Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 5 mg/25mL N 20181231 59078-015_f6be680e-c96d-4848-9270-6ea9e2c02a89 59078-015 HUMAN OTC DRUG Intense Care Snail ampoule Glycerin LIQUID TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN .8 mg/81 N 20181231 59078-016_edb20950-ccf8-4a4c-901d-e74bea567944 59078-016 HUMAN OTC DRUG Intense Care Snail Hydro Gel Mask Glycerin PATCH TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 5 g/25g N 20181231 59078-017_01c811fa-fc51-4841-b7a6-555a32be5a2e 59078-017 HUMAN OTC DRUG The Oriental Gyeol Goun Two Way Pact Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.33; 1.2; .59 g/20g; g/20g; g/20g N 20181231 59078-018_eec4a706-68ac-4282-b018-32549c961da4 59078-018 HUMAN OTC DRUG G9 Moisture CC SPF30 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 3.36; 3; 1; .96 g/50g; g/50g; g/50g; g/50g N 20181231 59078-019_3e0974d9-b70e-4fca-bcdb-4a68abfcce6e 59078-019 HUMAN OTC DRUG Timeless EGF Power Toner Glycerin LIQUID TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 28 mg/140mL N 20181231 59078-020_ecd3c09e-07b7-4cdc-9388-3e6d8166614a 59078-020 HUMAN OTC DRUG Timeless EGF Power Essence Dimethicone CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE 7 mg/35mL N 20181231 59078-021_5c8e1d63-9d18-4855-8350-55bbab053d61 59078-021 HUMAN OTC DRUG Timeless EGF Power Emulsion Dimethicone CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE 1.4 mg/140mL N 20181231 59078-022_185a9e61-9ff0-4717-9ca2-e746562493e5 59078-022 HUMAN OTC DRUG Timeless EGF Power Dimethicone CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE 1.5 mg/50mL N 20181231 59078-023_5bc159bb-5132-4928-904a-663f4740da17 59078-023 HUMAN OTC DRUG Timeless EGF Power Eye Dimethicone CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE .6 mg/30mL N 20181231 59078-024_fa4c0881-feb4-4d2a-827e-838e70a2cfc9 59078-024 HUMAN OTC DRUG Timeless Placenta Bound GLYCERIN, DIMETHICONE CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN; DIMETHICONE 15; 1.5 mg/50mL; mg/50mL N 20181231 59078-025_8ec24db6-48a8-4278-88e6-dcc6164afd3d 59078-025 HUMAN OTC DRUG Timeless Placenta Hydrogel Mask Titanium Dioxide PATCH TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE .001 g/30g N 20181231 59078-026_1f3f124e-fd70-445e-90e6-2b5253879f86 59078-026 HUMAN OTC DRUG Luminous AuraCapsule CC Titanium Dioxide, OCTINOXATE, OCTISALATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 4.09; 3.75; 2.5; 2.45 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 59078-027_d6721586-5cd5-49ab-8f05-fd33dce063f6 59078-027 HUMAN OTC DRUG Luminous Pure Aura CC Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.6; 2.5; 2.45 mg/50mL; mg/50mL; mg/50mL N 20181231 59078-028_b5eb62ca-1c4a-4e63-a660-1cfc6c37e534 59078-028 HUMAN OTC DRUG Luminous Live Aura CC Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.61; 2.5; 2.45 mg/50mL; mg/50mL; mg/50mL N 20181231 59078-029_dd51fb89-b616-4727-83c5-2badc9825954 59078-029 HUMAN OTC DRUG Luminous Bright Aura CC OCTINOXATE, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1.01; .88 mg/30mL; mg/30mL; mg/30mL N 20181231 59078-030_742d79c5-f721-4f6a-a100-1df8231017ff 59078-030 HUMAN OTC DRUG Luminous Goddess Aura Live Melting Foundation Titanium Dioxide, OCTINOXATE, Zinc Oxide POWDER TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.54; .9; .88 g/18g; g/18g; g/18g N 20181231 59078-031_5d913f88-d6f7-424c-b147-229b3e29e0f8 59078-031 HUMAN OTC DRUG BB fit Perfect 24 BB 01 Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 6.21; 1.5; .96 g/50g; g/50g; g/50g N 20181231 59078-032_c8db48dc-f94f-4d25-97d8-f08415ba2246 59078-032 HUMAN OTC DRUG BB fit Perfect 24 BB 02 Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 6.21; 1.5; .96 g/50g; g/50g; g/50g N 20181231 59078-033_5e51ad66-9742-49be-a53f-72409d6ce170 59078-033 HUMAN OTC DRUG BB fit Sheer BB Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.09; 1.5; .96 g/50g; g/50g; g/50g N 20181231 59078-034_79837446-1556-46bc-be6c-0f68ef71d5da 59078-034 HUMAN OTC DRUG Tomatox Magic Massage Pack Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 24 g/80g N 20181231 59078-035_8dea0867-c09e-4c66-bc18-08b46d94431f 59078-035 HUMAN OTC DRUG Face Mix Make up Base Green OCTINOXATE, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1.5; 1; .88 g/30g; g/30g; g/30g N 20181231 59078-036_e9b9fa32-1342-42ec-a006-ccef039d1ddf 59078-036 HUMAN OTC DRUG Tangerin Whitening Hand Glycerin CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 6 g/30g N 20181231 59078-037_0e14a326-5593-44a0-83c8-aa703d02127e 59078-037 HUMAN OTC DRUG UV SUNSET Body And Family Sun OCTINOXATE, OCTISALATE, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 7.5; 5; 4.9; 2.9 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 59078-038_7ea7cc72-29ec-4e7d-9cd4-8c69e9829ead 59078-038 HUMAN OTC DRUG MINI BERRY LIP BALM BLUEBERRY OCTINOXATE, Titanium Dioxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .36; .01 g/7.2g; g/7.2g N 20181231 59078-039_61de4f1f-7d13-4b43-b19c-8d0a150a978e 59078-039 HUMAN OTC DRUG Face Mix Skin Foundation Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.83; 1.2; .29 g/30g; g/30g; g/30g N 20181231 59078-040_e35348f1-1437-403e-919e-60727e7e42d5 59078-040 HUMAN OTC DRUG Aqua Aura Moist Finish Pact TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE .97; .1 g/10g; g/10g N 20181231 59078-041_8decda20-c938-45f1-8c86-d1b706e058a5 59078-041 HUMAN OTC DRUG UV SUNSET Waterproof Sun Block ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE 8.06; 2.1 g/60g; g/60g N 20181231 59078-042_76c21478-3b83-4071-b4f7-a0bd20d800a7 59078-042 HUMAN OTC DRUG LUMINOUS GODDESS AURA BB Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.47; 3.15; 1.32 g/45g; g/45g; g/45g N 20181231 59078-043_b46bcccf-4068-4862-adee-23056125093a 59078-043 HUMAN OTC DRUG MINI BERRY LIP BALM CHERRY OCTINOXATE, Titanium Dioxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE .36; .06 g/7.2g; g/7.2g N 20181231 59078-044_ef7028b7-d70e-4647-b2d4-5e8ef5ef3334 59078-044 HUMAN OTC DRUG Prestige Snail Lip Treatment OCTINOXATE, OCTISALATE STICK TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; OCTISALATE .24; .14 g/3.5g; g/3.5g N 20181231 59078-045_125afb33-ecb3-4464-acb2-76a756ea3002 59078-045 HUMAN OTC DRUG TONYMOLY INTENSE CARE GOLD 24K SNAIL Dimethicone CREAM TOPICAL 20140501 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE .45 mg/45mL N 20181231 59078-046_53cc4347-b0da-4dfb-b9ed-e13dd2846ff5 59078-046 HUMAN OTC DRUG TONYMOLY KISS KISS LIP ESSENCE BALM OCTINOXATE CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE .36 g/7.2g N 20181231 59078-047_286c1ce5-394b-4d36-acdb-83f69225948a 59078-047 HUMAN OTC DRUG TONYMOLY My Sunny Perfecting Sun Block OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 7.5; 4.25; 2 mg/100mL; mg/100mL; mg/100mL N 20181231 59078-048_6c6d5f46-f341-45b9-9a88-33a32b1489f6 59078-048 HUMAN OTC DRUG TONYMOLY BCDATION 01 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 5.22; .72 g/50g; g/50g N 20181231 59078-049_e9327375-ac08-4b03-92cd-baa3f749d257 59078-049 HUMAN OTC DRUG TONYMOLY BCDATION 02 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 5.22; .72 g/50g; g/50g N 20181231 59078-050_95a514b4-d68b-45a2-a327-979d6a8ddc25 59078-050 HUMAN OTC DRUG TONYMOLY FLORIA WHITENING ESSENCE Dimethicone CREAM TOPICAL 20140501 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. DIMETHICONE .5 mg/50mL N 20181231 59078-051_a9c482a2-553b-491c-b76c-419e3ab9198c 59078-051 HUMAN OTC DRUG TONYMOLY INTENSE CARE SNAIL BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 Tonymoly Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3.15 mg/50mL; mg/50mL N 20181231 59078-052_8220f498-5457-4241-8dd2-1aa3c1733e68 59078-052 HUMAN OTC DRUG TONYMOLY LUMINOUS GODDESS AURA BB 02 Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Tonymoly Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.47; 3.15; 1.32 g/45g; g/45g; g/45g N 20181231 59078-053_e2669d43-fc9b-4714-82ea-391d4773e626 59078-053 HUMAN OTC DRUG TANGERINE HAND Glycerin CREAM TOPICAL 20140501 OTC MONOGRAPH FINAL part347 TONYMOLY CO., LTD. GLYCERIN 6 g/30g N 20181231 59078-054_40773d09-23d5-4eaf-b30f-2cc597834921 59078-054 HUMAN OTC DRUG TONYMOLY INTENSE CARE SNAIL Glycerin CREAM TOPICAL 20150301 UNAPPROVED DRUG OTHER TONYMOLY CO., LTD. GLYCERIN 1 g/45g N 20181231 59078-100_2ace2ee8-0a2f-607e-e054-00144ff88e88 59078-100 HUMAN OTC DRUG TONYMOLY Timeless Ferment Snail Toner Glycerin LIQUID TOPICAL 20160114 OTC MONOGRAPH FINAL part346 Tonymoly Co., Ltd. GLYCERIN 1762.6 mg/140mL N 20181231 59078-101_2acc7633-000b-23b4-e054-00144ff8d46c 59078-101 HUMAN OTC DRUG TONYMOLY Timeless Ferment Snail Emulsion Glycerin EMULSION TOPICAL 20160114 OTC MONOGRAPH FINAL part346 Tonymoly Co., Ltd. GLYCERIN 9694.3 mg/140mL E 20171231 59078-102_2aceb749-77c6-18e6-e054-00144ff8d46c 59078-102 HUMAN OTC DRUG TONYMOLY Timeless Ferment Snail Essence Glycerin LOTION TOPICAL 20160110 OTC MONOGRAPH FINAL part347 Tonymoly Co., Ltd. GLYCERIN 503 mg/50mL N 20181231 59078-103_2acf161f-2e3b-0e02-e054-00144ff88e88 59078-103 HUMAN OTC DRUG TONYMOLY Timeless Ferment Snail Cream Glycerin CREAM TOPICAL 20160110 OTC MONOGRAPH FINAL part346 Tonymoly Co., Ltd. GLYCERIN 4910.1 mg/50mL N 20181231 59078-104_2acfde18-58bb-2509-e054-00144ff88e88 59078-104 HUMAN OTC DRUG TONYMOLY Timeless Ferment Snail Eye Cream Glycerin CREAM TOPICAL 20160114 OTC MONOGRAPH FINAL part346 Tonymoly Co., Ltd. GLYCERIN 1510.8 mg/140mL N 20181231 59078-107_2ad03543-dcd3-2f6d-e054-00144ff88e88 59078-107 HUMAN OTC DRUG TONYMOLY BCDation All Master Titanium Dioxide CREAM TOPICAL 20160114 OTC MONOGRAPH FINAL part347 Tonymoly Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE; GLYCERIN .72; 6.2; .8 g/50g; g/50g; g/50g N 20181231 59078-108_2ad097f6-6547-67d0-e054-00144ff8d46c 59078-108 HUMAN OTC DRUG TONYMOLY My Sunny Waterproof Sun Block Zinc Oxide CREAM TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part352 Tonymoly Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE 8.064; 2.106 g/60g; g/60g N 20181231 59078-109_2ad1b071-5b04-2668-e054-00144ff8d46c 59078-109 HUMAN OTC DRUG TONYMOLY Aqua Aura Jelly Cushion01 SPF36 Pure Beige Titanium Dioxide POWDER TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part352 Tonymoly Co., Ltd. TITANIUM DIOXIDE 2.381 g/10g N 20181231 59078-110_2ad197f5-02ee-230f-e054-00144ff8d46c 59078-110 HUMAN OTC DRUG TONYMOLY Aura Jelly Cushion02 SPF36 Skin Beige Titanium Dioxide POWDER TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part352 Tonymoly Co., Ltd. TITANIUM DIOXIDE 2.381 g/10g N 20181231 59078-111_2adf8823-9af6-3538-e054-00144ff8d46c 59078-111 HUMAN OTC DRUG TONYMOLY Timeless Carat Moisture Soft Powder Pact 21 Skin Beige Titanium Dioxide POWDER TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part352 Tonymoly Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 1.267; .5488 g/14g; g/14g N 20181231 59078-112_2a68bb59-4d33-30eb-e054-00144ff88e88 59078-112 HUMAN OTC DRUG TONYMOLY Timeless Carat Moisture Soft Powder Pact 23 Natural Beige Ethylhexyl Methoxycinnamate POWDER TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part352 Tonymoly Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 1.267; .5488 g/14g; g/14g N 20181231 59078-112_ba575876-3cfc-4816-b32a-2986d41ab229 59078-112 HUMAN OTC DRUG TONYMOLY NATURALTH GOAT MILK WHITENING Dimethicone EMULSION TOPICAL 20151201 OTC MONOGRAPH FINAL part347 TONYMOLY CO.,LTD DIMETHICONE 9.6 g/150mL N 20181231 59078-113_2ae04e66-6bd9-5cd7-e054-00144ff8d46c 59078-113 HUMAN OTC DRUG TONYMOLY Regencia Homme Multi BB Cream SPF43 Titanium Dioxide CREAM TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part352 Tonymoly Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 18612; 10995.6 mg/50mL; mg/50mL N 20181231 59078-114_2ae20010-d291-10b7-e054-00144ff88e88 59078-114 HUMAN OTC DRUG TONYMOLY Bio EX Active Cell-Whitening Cream Glycerin CREAM TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part347 Tonymoly Co., Ltd. GLYCERIN; DIMETHICONE 3676.9095; 900 mg/45mL; mg/45mL N 20181231 59078-115_2ae1fa17-2730-2cca-e054-00144ff8d46c 59078-115 HUMAN OTC DRUG TONYMOLY Bio EX Active-Cell Essence Glycerin LOTION TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part356 Tonymoly Co., Ltd. GLYCERIN 12742.339 mg/145mL N 20181231 59078-116_2ae287a8-4b90-3ed3-e054-00144ff8d46c 59078-116 HUMAN OTC DRUG TONYMOLY Bio EX Active-Cell Real Serum Glycerin LOTION TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part356 Tonymoly Co., Ltd. GLYCERIN 8377.386 mg/60mL N 20181231 59078-117_2ae3123e-8e61-61d3-e054-00144ff8d46c 59078-117 HUMAN OTC DRUG TONYMOLY Bio EX Active-Cell Eye-Face Cream Glycerin CREAM TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part356 Tonymoly Co., Ltd. GLYCERIN 5926.7425 mg/35mL N 20181231 59078-118_2af42ad0-d211-6a6a-e054-00144ff8d46c 59078-118 HUMAN OTC DRUG TONYMOLY Bio EX Active-Cell Night Cream Glycerin CREAM TOPICAL 20160114 OTC MONOGRAPH FINAL part346 Tonymoly Co., Ltd. GLYCERIN 5.05 g/50g N 20181231 59078-119_2b07eb3a-5d5b-4ede-e054-00144ff8d46c 59078-119 HUMAN OTC DRUG TONYMOLY My Sunny Touch Free Sun Block Titanium Dioxide CREAM TOPICAL 20160114 OTC MONOGRAPH FINAL part346 Tonymoly Co., Ltd. ZINC OXIDE; GLYCERIN 2.52; 2.268 g/40g; g/40g N 20181231 59078-120_2af68f0b-4b4d-5387-e054-00144ff8d46c 59078-120 HUMAN OTC DRUG TONYMOLY My Sunny All SunSpray Ethylhexyl Methoxycinnamate SPRAY TOPICAL 20160114 OTC MONOGRAPH FINAL part352 Tonymoly Co., Ltd. TITANIUM DIOXIDE; OCTOCRYLENE 20557.8; 4725 mg/150mL; mg/150mL N 20181231 59078-121_2af6dab7-0e94-245f-e054-00144ff88e88 59078-121 HUMAN OTC DRUG TONYMOLY My Sunny Body and Family Sun Cream Ethylhexyl Methoxycinnamate CREAM TOPICAL 20160114 OTC MONOGRAPH FINAL part346 Tonymoly Co., Ltd. GLYCERIN; ZINC OXIDE 6295; 27489 mg/100mL; mg/100mL N 20181231 59078-122_2af6e1bc-9945-188c-e054-00144ff88e88 59078-122 HUMAN OTC DRUG TONYMOLY My Sunny Watery Sun Gel Ethylhexyl Methoxycinnamate GEL TOPICAL 20160114 OTC MONOGRAPH FINAL part346 Tonymoly Co., Ltd. GLYCERIN .252 g/45g N 20181231 59078-123_2af84178-8ecd-2147-e054-00144ff8d46c 59078-123 HUMAN OTC DRUG TONYMOLY My Sunny Tok Tok Sun Powder Titanium Dioxide POWDER TOPICAL 20160114 OTC MONOGRAPH FINAL part352 Tonymoly Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE .3651; .0576 g/3g; g/3g N 20181231 59078-124_2af84178-8edb-2147-e054-00144ff8d46c 59078-124 HUMAN OTC DRUG TONYMOLY My Sunny Kids and Mom Sun Cream Zinc Oxide CREAM TOPICAL 20160114 OTC MONOGRAPH FINAL part352 Tonymoly Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE 27466.56; 14745.78 mg/60mL; mg/60mL N 20181231 59078-125_2af94304-811d-41c7-e054-00144ff8d46c 59078-125 HUMAN OTC DRUG TONYMOLY My Sunny All In One Sun SPF45 Ethylhexyl Methoxycinnamate CREAM TOPICAL 20160114 OTC MONOGRAPH FINAL part352 Tonymoly Co., Ltd. TITANIUM DIOXIDE; GLYCERIN; OCTOCRYLENE 17977.5; 8145.73; 2100 mg/100mL; mg/100mL; mg/100mL N 20181231 59078-126_2a7e5d97-e323-3594-e054-00144ff88e88 59078-126 HUMAN OTC DRUG TONYMOLY Timeless GF-Factor Toner Glycerin LIQUID TOPICAL 20160114 OTC MONOGRAPH FINAL part346 Tonymoly Co., Ltd. GLYCERIN 14100.8 mg/140mL N 20181231 59078-127_2a7ee15f-8ebe-4a2c-e054-00144ff8d46c 59078-127 HUMAN OTC DRUG TONYMOLY Timeless GF-Factor Emulsion Glycerin EMULSION TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part356 Tonymoly Co., Ltd. DIMETHICONE; GLYCERIN 1344; 17626 mg/140mL; mg/140mL N 20181231 59078-128_2a7ee15f-8ec2-4a2c-e054-00144ff8d46c 59078-128 HUMAN OTC DRUG TONYMOLY Timeless GF-Factor Cream Glycerin CREAM TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part356 Tonymoly Co., Ltd. DIMETHICONE; GLYCERIN 1440; 5067.475 mg/50mL; mg/50mL N 20181231 59078-129_2a805bf7-a611-2411-e054-00144ff8d46c 59078-129 HUMAN OTC DRUG TONYMOLY Pure Farm Pig Collagen Hydrogel Mask Glycerin PATCH TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part356 Tonymoly Co., Ltd. GLYCERIN 1.5 g/30g N 20181231 59078-131_2a80ab69-037e-74ff-e054-00144ff88e88 59078-131 HUMAN OTC DRUG TONYMOLY Placenta Bound Toner Glycerin LIQUID TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part356 Tonymoly Co., Ltd. GLYCERIN 5287.8 mg/140mL N 20181231 59078-132_2ab65eb0-4e54-5ee3-e054-00144ff8d46c 59078-132 HUMAN OTC DRUG TONYMOLY Premium RX Camel Milk Cream Glycerin CREAM TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part356 Tonymoly Co., Ltd. GLYCERIN 2.1 g/70g E 20171231 59078-134_2ab771d0-25af-1256-e054-00144ff8d46c 59078-134 HUMAN OTC DRUG TONYMOLY Premium RX Horse Yu Hand Cream Glycerin CREAM TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part356 Tonymoly Co., Ltd. GLYCERIN 3147.5 mg/50mL N 20181231 59078-135_2ab8290c-2d0d-6f9d-e054-00144ff88e88 59078-135 HUMAN OTC DRUG TONYMOLY Timeless Carat Foun Cover 01 Skin Beige Titanium Dioxide CREAM TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part352 Tonymoly Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; DIMETHICONE 2.33225; .7448; .304 g/9.5g; g/9.5g; g/9.5g N 20181231 59078-136_2a4022d5-9093-10c0-e054-00144ff8d46c 59078-136 HUMAN OTC DRUG Tonymoly Timeless Carat Foun Cover 02 Natural Beige Titanium Dioxide CREAM TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part352 Tonymoly Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; DIMETHICONE 2.33225; .7448; .304 g/9.5g; g/9.5g; g/9.5g N 20181231 59078-137_2abb1649-6b38-50b7-e054-00144ff8d46c 59078-137 HUMAN OTC DRUG TONYMOLY Timeless Ferment Snail BB Cream Titanium Dioxide CREAM TOPICAL 20160110 OTC MONOGRAPH FINAL part347 Tonymoly Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE 5610; 423 mg/50mL; mg/50mL N 20181231 59078-138_2abb1649-6b3a-50b7-e054-00144ff8d46c 59078-138 HUMAN OTC DRUG TONYMOLY Face Mix Skin Makeup Base 02 Mix Lavendar SPF20 Titanium Dioxide LOTION TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part352 Tonymoly Co., Ltd. GLYCERIN; TITANIUM DIOXIDE; ZINC OXIDE; DIMETHICONE .6; 2.835; .3; .3 g/30g; g/30g; g/30g; g/30g N 20181231 59078-140_2abbe361-4c28-6c60-e054-00144ff88e88 59078-140 HUMAN OTC DRUG TONYMOLY Fitting Foundation 23 SPF30 Natural Beige Titanium Dioxide LOTION TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part352 Tonymoly Co., Ltd. GLYCERIN; TITANIUM DIOXIDE; ZINC OXIDE; DIMETHICONE 881.3; 13990.725; 1963.5; 1963.5 mg/35mL; mg/35mL; g/35mL; mg/35mL N 20181231 59078-144_2ae1fa17-2731-2cca-e054-00144ff8d46c 59078-144 HUMAN OTC DRUG TONYMOLY Intense Care Gold Syn-Ake Wrinkle Cream Glycerin CREAM TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part356 Tonymoly Co., Ltd. GLYCERIN; YELLOW WAX 9857.97; 864.9 mg/45mL; mg/45mL N 20181231 59078-145_2acaac52-bd8f-3c3a-e054-00144ff8d46c 59078-145 HUMAN OTC DRUG TONYMOLY Intense Care Gold Syn-Ake Wrinkle Perfector Glycerin INJECTABLE FOAM TOPICAL 20160114 OTC MONOGRAPH FINAL part352 Tonymoly Co., Ltd. DIMETHICONE; GLYCERIN 912.96; 2171.775 mg/15mL; mg/15mL N 20181231 59078-150_2b6c886d-5033-3a45-e054-00144ff88e88 59078-150 HUMAN OTC DRUG TONYMOLY Pandas Dream Brightening Eye Base Dimethicone CREAM TOPICAL 20160114 OTC MONOGRAPH FINAL part347 Tonymoly Co., Ltd. TITANIUM DIOXIDE; LANOLIN; GLYCERIN; DIMETHICONE .1764; .18; .000135; 1.089 g/9g; g/9g; g/9g; g/9g N 20181231 59078-152_2b85f5e8-aabe-44e1-e054-00144ff8d46c 59078-152 HUMAN OTC DRUG TONYMOLY Pandas Dream White Hand Cream Glycerin CREAM TOPICAL 20160114 OTC MONOGRAPH FINAL part347 Tonymoly Co., Ltd. DIMETHICONE; GLYCERIN .15; 2.1 g/30g; g/30g N 20181231 59078-200_9b5a0af9-f5f8-4013-8779-6c73faf827cc 59078-200 HUMAN OTC DRUG TONYMOLY NATURALTH GOAT MILK WHITENING TONER Niacinamide LIQUID TOPICAL 20151201 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD NIACINAMIDE 3 g/150mL N 20181231 59078-210_8be94884-a833-48be-a2fe-ced3e5bcf943 59078-210 HUMAN OTC DRUG TONYMOLY MAGIC FOOD MANGO MILD SUN BLOCK OCTINOXATE, OCTISALATE, AVOBENZONE, ENSULIZOLE, HOMOSALATE CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO.,LTD OCTINOXATE; OCTISALATE; AVOBENZONE; ENSULIZOLE; HOMOSALATE 3.1; 2.02; 1.57; 1.57; 1.35 g/45g; g/45g; g/45g; g/45g; g/45g N 20181231 59078-220_cbfe007c-f84a-4e70-b422-28d82e90e075 59078-220 HUMAN OTC DRUG TONYMOLY PANDAS DREAM WHITE HAND Niacinamide CREAM TOPICAL 20151201 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD NIACINAMIDE .6 g/30g N 20181231 59078-230_8de72a70-b5c9-4183-89a6-c585153b2366 59078-230 HUMAN OTC DRUG TONYMOLY NATURALTH GOAT MILK PREMIUM MOISTURE Dimethicone CREAM TOPICAL 20151201 OTC MONOGRAPH FINAL part347 TONYMOLY CO.,LTD DIMETHICONE 2.1 g/60mL N 20181231 59078-240_73c79e9e-eb7b-400d-8a88-78627e629902 59078-240 HUMAN OTC DRUG TONYMOLY NATURALTH GOAT MILK PREMIUM EYE Glycerin CREAM TOPICAL 20151201 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD GLYCERIN 5.04 g/30mL N 20181231 59078-250_fef6201a-0124-44fe-96e9-d15a1032ffeb 59078-250 HUMAN OTC DRUG TONYMOLY NATURALTH GOAT MILK PREMIUM Dimethicone CREAM TOPICAL 20151201 OTC MONOGRAPH FINAL part347 TONYMOLY CO.,LTD DIMETHICONE .6 g/60mL N 20181231 59078-260_dcd3daaf-b761-41d9-85bb-c1c373e4e349 59078-260 HUMAN OTC DRUG TONYMOLY NATURALTH GOAT MILK WHITENING ESSENCE Niacinamide CREAM TOPICAL 20151201 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD NIACINAMIDE 1 g/50mL N 20181231 59078-270_517cfa27-f22a-4e82-99d8-ad6b3b2d2000 59078-270 HUMAN OTC DRUG TONYMOLY NATURALTH GOAT MILK AQUA WHITENING Dimethicone CREAM TOPICAL 20151201 OTC MONOGRAPH FINAL part347 TONYMOLY CO.,LTD DIMETHICONE .6 g/60mL N 20181231 59078-280_5a61f5f8-5341-4877-ad53-d1c30264f528 59078-280 HUMAN OTC DRUG NATURALTH GOAT MILK MOISTURE Glycerin EMULSION TOPICAL 20160501 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD GLYCERIN 9 g/150mL N 20181231 59078-290_7a76b3a7-1c36-4176-98b4-f9c861c9e45d 59078-290 HUMAN OTC DRUG NATURALTH GOAT MILK MOISTURE ESSENCE Dimethicone CREAM TOPICAL 20160501 OTC MONOGRAPH FINAL part347 TONYMOLY CO.,LTD DIMETHICONE .8 g/50mL N 20181231 59078-300_06bc50e0-d3a2-4c3d-acd5-89b677d2f8dc 59078-300 HUMAN OTC DRUG NATURALTH GOAT MILK MOISTURE TONER Glycerin LIQUID TOPICAL 20160501 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD GLYCERIN .15 g/150mL N 20181231 59078-301_baf498ee-f710-47b8-83d9-72de31584438 59078-301 HUMAN OTC DRUG NATURALTH GOAT MILK PREMIUM TONE UP Glycerin, Niacinamide CREAM TOPICAL 20160501 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD GLYCERIN; NIACINAMIDE 9.3; 1.2 g/60mL; g/60mL N 20181231 59078-302_c09f35bf-eeb6-455d-ab39-9d37a470aca4 59078-302 HUMAN OTC DRUG The Chok Chok Green Tea Watery Essence GREEN TEA LEAF CREAM TOPICAL 20160501 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD GREEN TEA LEAF 44.71 g/55mL N 20181231 59078-303_c3826504-2e16-4ed0-b453-e8c305dc17d0 59078-303 HUMAN OTC DRUG The Hayan Cherry Blossom Brightening Essence Niacinamide CREAM TOPICAL 20160501 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD NIACINAMIDE 1.1 g/55mL N 20181231 59078-304_038d6287-9e2b-496c-bd92-a77adb774cc3 59078-304 HUMAN OTC DRUG Im real Aloe Soothing Dimethicone LOTION TOPICAL 20160501 OTC MONOGRAPH FINAL part347 TONYMOLY CO.,LTD DIMETHICONE 2 g/200mL N 20181231 59078-305_de979d35-0aca-46ee-9dde-71ea075b858f 59078-305 HUMAN OTC DRUG Im real Lemon Brightening Dimethicone LOTION TOPICAL 20160501 OTC MONOGRAPH FINAL part347 TONYMOLY CO.,LTD DIMETHICONE 2 g/200mL N 20181231 59078-306_5ac771e3-7c01-4d42-b373-dfe195801081 59078-306 HUMAN OTC DRUG Im real Rice Smooth Toner Glycerin LIQUID TOPICAL 20160501 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD GLYCERIN 2.5 g/250mL N 20181231 59078-307_d6481ead-dded-43c9-a9d1-d8587e3a11d4 59078-307 HUMAN OTC DRUG Im real SEAWEED AQUA MOISTURE Butylene Glycol LOTION TOPICAL 20160501 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD BUTYLENE GLYCOL 30 g/200mL N 20181231 59078-308_6e15fba3-7571-4ecd-9846-7d47cbc131d8 59078-308 HUMAN OTC DRUG Im real TEA TREE SEBUM and Pore Glycerin LOTION TOPICAL 20160501 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD GLYCERIN 8 g/200mL N 20181231 59078-309_0032aaf3-6958-468d-ac2b-7c8ab30dc572 59078-309 HUMAN OTC DRUG MY SUNNY POWDE RY FINISH SUN MILK Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO.,LTD TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.86; 1.8; 1.29 g/45mL; g/45mL; g/45mL N 20181231 59078-310_818abe50-91e3-4849-a2b8-b5eff896dd9c 59078-310 HUMAN OTC DRUG TIMELESS FERMENT SANIL SUN Octinoxate, Octisalate, ENSULIZOLE, AVOBENZONE CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO.,LTD OCTINOXATE; OCTISALATE; ENSULIZOLE; AVOBENZONE 2.75; 2.5; 2; 1.5 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 59078-311_5a2e70b0-f8c2-40a6-989c-f06b82bc016b 59078-311 HUMAN OTC DRUG 2X FIRST ESSENCE Glycerin CREAM TOPICAL 20160501 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD GLYCERIN 4 g/200mL N 20181231 59078-312_93e162ab-daba-49e1-be57-d57ada0fb16a 59078-312 HUMAN OTC DRUG PANDAS DREAM MAGIC Glycerin, Niacinamide CREAM TOPICAL 20160501 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD GLYCERIN; NIACINAMIDE 3; 1 g/50g; g/50g N 20181231 59078-313_7db041f6-9554-4dff-9ee6-6251fee01ef4 59078-313 HUMAN OTC DRUG ANG EL GLOWR ING HAIR MASK Dimethicone PATCH TOPICAL 20160501 OTC MONOGRAPH FINAL part347 TONYMOLY CO.,LTD DIMETHICONE .6 g/20g N 20181231 59078-314_70a71753-0ede-4086-9d36-ebe2a2fda76a 59078-314 HUMAN OTC DRUG PANDAS DREAM SO COOL EYE SERUM Dimethicone STICK TOPICAL 20160501 OTC MONOGRAPH FINAL part347 TONYMOLY CO.,LTD DIMETHICONE .09 g/9g N 20181231 59078-315_41d4ce8b-4239-4834-8a96-60eaf62d86eb 59078-315 HUMAN OTC DRUG MINI PEACH LIP BALM Shea Butter CREAM TOPICAL 20160501 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD SHEA BUTTER 1.05 g/7g N 20181231 59078-316_9748550f-5cad-4fb2-8450-f004d0b5fa18 59078-316 HUMAN OTC DRUG PRESTIGE JEJU SNAIL Niacinamide, Dimethicone CREAM TOPICAL 20160701 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD NIACINAMIDE; DIMETHICONE .9; .22 g/45mL; g/45mL N 20181231 59078-317_55749ab6-7372-4751-a2fb-ce13b5da2579 59078-317 HUMAN OTC DRUG PRESTIGE JEJU SNAIL EYE Dimethicone CREAM TOPICAL 20160701 OTC MONOGRAPH FINAL part347 TONYMOLY CO.,LTD DIMETHICONE 3.05 g/30mL N 20181231 59078-318_8f86b1c0-3de7-4d24-8501-3e7606c8d1d6 59078-318 HUMAN OTC DRUG PRESTIGE JEJU SNAIL Glycerin, Niacinamide EMULSION TOPICAL 20160701 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD GLYCERIN; NIACINAMIDE 11.22; 2.5 g/125mL; g/125mL N 20181231 59078-319_31fd18df-7fce-4a1f-a932-998c8d3b2985 59078-319 HUMAN OTC DRUG PRESTIGE JEJU SNAIL ESSENCE Glycerin, Niacinamide CREAM TOPICAL 20160701 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD GLYCERIN; NIACINAMIDE 2.76; 1 g/50mL; g/50mL N 20181231 59078-320_cb299be5-1755-49ab-8cb3-5b7738927873 59078-320 HUMAN OTC DRUG PRESTIGE JEJU SNAIL TONER Glycerin, Niacinamide LIQUID TOPICAL 20160701 UNAPPROVED DRUG OTHER TONYMOLY CO.,LTD GLYCERIN; NIACINAMIDE 6.43; 2.5 g/125mL; g/125mL N 20181231 59078-321_06804983-bbf7-4056-8537-aa89f97811b3 59078-321 HUMAN OTC DRUG MINI BLING POCKET HAIR PACK DIMETHICONE PATCH TOPICAL 20160815 OTC MONOGRAPH FINAL part347 TONYMOLY CO.,LTD DIMETHICONE .16 g/8g N 20181231 59078-322_88322e58-a28f-41d2-ad0a-c4906f09e6fc 59078-322 HUMAN OTC DRUG Tonymoly Latte Art Cappuccino Cre am In Scrub Glycerin CREAM TOPICAL 20161010 OTC MONOGRAPH FINAL part347 TONYMOLY CO.,LTD GLYCERIN 78.1 g/95g N 20181231 59078-323_a9c1fab4-044c-48a7-b7b0-5f71bd391ac1 59078-323 HUMAN OTC DRUG TONYMOLY BCDATION MULTI USE SUN Octinoxate, Homosalate, Octisalate OIL TOPICAL 20170103 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO.,LTD OCTINOXATE; HOMOSALATE; OCTISALATE 2.1; 1.8; 1.35 g/30mL; g/30mL; g/30mL N 20181231 59078-324_a07fd3b0-c984-49f4-b627-42fb14b67b41 59078-324 HUMAN OTC DRUG MY SUNNY WATERY SUN ESSENCE OCTINOXATE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO.,LTD OCTINOXATE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3.4; 3; 2.25; 1.25 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 59078-325_42aeea79-4643-4d90-a3aa-e5b5114068aa 59078-325 HUMAN OTC DRUG INTENSE CARE GOLD 24K SNAIL SUN Homosalate, Octisalate, Ensulizole, Octocrylene CREAM TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 TONYMOLY CO.,LTD HOMOSALATE; OCTISALATE; ENSULIZOLE; OCTOCRYLENE 3.5; 2.25; 1.5; .5 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 59086-085_ac72eb44-3edb-4119-8ffe-b2a482ab728d 59086-085 HUMAN OTC DRUG MY INSTANT HAND SANITIZER with aloe and vitamin e ETHYL ALCOHOL GEL TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part333E Mapco Express ALCOHOL 620 mg/mL N 20181231 59088-062_ecc2562c-6b4e-4a44-99ab-5d128e72a9cb 59088-062 HUMAN PRESCRIPTION DRUG DermacinRx Inflammatral Pak diclofenac sodium delayed release tablets, ranitidine tablets, capsaicin cream KIT 20150612 ANDA ANDA077863 PureTek Corporation N 20181231 59088-083_a587b90d-78bf-4955-955b-73d246d688b0 59088-083 HUMAN PRESCRIPTION DRUG Migranow sumatriptan succinate, camphor, menthol KIT 20160418 UNAPPROVED DRUG OTHER PureTek Corporation N 20181231 59088-090_23acb62e-2a2d-5a47-e054-00144ff88e88 59088-090 HUMAN PRESCRIPTION DRUG DermacinRx PureFolix Folic Acid, Vitamin D3 TABLET ORAL 20151103 UNAPPROVED DRUG OTHER PureTek Corporation FOLIC ACID; VITAMIN D 1; 125 mg/1; ug/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 59088-093_9da62b8e-7e53-42d8-b490-a6632e34a332 59088-093 HUMAN PRESCRIPTION DRUG Inflammacin diclofenac sodium, capsaicin KIT 20160111 ANDA ANDA075185 PureTek Corporation N 20181231 59088-096_865635a3-3f04-4001-a2ab-62a305c3ad5c 59088-096 HUMAN PRESCRIPTION DRUG Prenatal, DHA thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, choline bitartrate, and doconexent KIT 20170810 UNAPPROVED DRUG OTHER PureTek Corporation N 20181231 59088-104_abb6278b-7f67-454d-bc45-70b2feed4289 59088-104 HUMAN PRESCRIPTION DRUG Fluoride Sodium Fluoride TABLET, CHEWABLE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation SODIUM FLUORIDE .25 mg/1 N 20181231 59088-105_db77bcae-d6c7-4ce8-b63d-1f6ad0b8b7bc 59088-105 HUMAN PRESCRIPTION DRUG Fluoride Sodium Fluoride TABLET, CHEWABLE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation SODIUM FLUORIDE .5 mg/1 N 20181231 59088-106_4ff12dfe-6416-438a-955d-fb7fe0515e53 59088-106 HUMAN PRESCRIPTION DRUG Fluoride Sodium Fluoride TABLET, CHEWABLE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation SODIUM FLUORIDE 1 mg/1 N 20181231 59088-107_314c4eba-6a4e-480c-b6da-ae849c15ce07 59088-107 HUMAN PRESCRIPTION DRUG Multivitamin with Fluoride Sodium Fluoride TABLET, CHEWABLE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN .25; 2500; 24; 36; 400; 15; 1.05; 1.2; 13.5; 1.05; 300; 4.5 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 59088-108_5fe40b56-0d4b-4ce7-b7b4-762ea4f3115f 59088-108 HUMAN PRESCRIPTION DRUG Multivitamin with Fluoride Sodium Fluoride TABLET, CHEWABLE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN .5; 2500; 24; 36; 400; 15; 1.05; 1.2; 13.5; 1.05; 300; 4.5 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 59088-109_a13bdc11-846e-49fe-9196-4c0e8c04ca18 59088-109 HUMAN PRESCRIPTION DRUG Multivitamin with Fluoride Sodium Fluoride TABLET, CHEWABLE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN 1; 2500; 24; 36; 400; 15; 1.05; 1.2; 13.5; 1.05; 300; 4.5 mg/1; [iU]/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 59088-112_4d17e61e-bc2a-42ca-a019-4f3801ba2108 59088-112 HUMAN PRESCRIPTION DRUG PureVit DualFe Plus Ferrous Fumarate, Polysaccharide Iron Complex CAPSULE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation FERROUS FUMARATE; IRON DEXTRAN; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE; CUPRIC SULFATE; MANGANESE SULFATE 53; 53; 6; 30; 5; 1; 15; 10; 200; 10; 18.2; .8; 1.3 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] N 20181231 59088-113_513d5b5f-1f99-42b6-8256-7c9de4b8d1a9 59088-113 HUMAN PRESCRIPTION DRUG PureFe OB Plus Ferrous Fumarate and Polysaccharide Iron Complex CAPSULE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation FERROUS FUMARATE; IRON DEXTRAN; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; MAGNESIUM SULFATE, UNSPECIFIED; ZINC SULFATE; CUPRIC SULFATE; MANGANESE SULFATE 53; 53; 6; 30; 5; 1; 15; 10; 200; 10; 6.9; 18.2; .8; 1.3 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] N 20181231 59088-114_d726c3d0-9d1f-43ea-8971-30ecba0e87b7 59088-114 HUMAN PRESCRIPTION DRUG PureFe Plus Ferrous Fumarate CAPSULE ORAL 20110601 UNAPPROVED DRUG OTHER PureTek Corporation FERROUS FUMARATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; MAGNESIUM SULFATE, UNSPECIFIED; ZINC SULFATE; CUPRIC SULFATE; MANGANESE SULFATE 106; 10; 6; 30; 5; 1; 15; 10; 200; 6.9; 18.2; .8; 1.3 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] N 20181231 59088-115_74e6eada-1f23-4201-90ad-d2756e14820a 59088-115 HUMAN PRESCRIPTION DRUG PNV OB DHA Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium, Docosahexaenoic Acid (DHA) KIT 20110601 UNAPPROVED DRUG OTHER PureTek Corporation N 20181231 59088-120_3fe54497-e71b-43d8-bb09-ef4b62541e14 59088-120 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20110707 OTC MONOGRAPH FINAL part343 PureTek Corporation ASPIRIN 325 mg/1 N 20181231 59088-128_37b19575-02b8-25b6-e054-00144ff8d46c 59088-128 HUMAN PRESCRIPTION DRUG DermacinRx FoliPlus D Folic Acid, Vitamin D3 CAPSULE, LIQUID FILLED ORAL 20160715 UNAPPROVED DRUG OTHER PureTek Corporation FOLIC ACID; VITAMIN D 1; 83.325 mg/1; ug/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 59088-283_340acace-7080-46f3-b992-487724175f73 59088-283 HUMAN OTC DRUG Camphotrex camphor, menthol GEL TOPICAL 20160412 OTC MONOGRAPH NOT FINAL part348 PureTek Corporation CAMPHOR (SYNTHETIC); MENTHOL 4; 10 g/100g; g/100g N 20181231 59088-310_1e343a52-6072-3230-e054-00144ff8d46c 59088-310 HUMAN OTC DRUG DermacinRx Penetral Cream Capsaicin CREAM TOPICAL 20150609 OTC MONOGRAPH NOT FINAL part348 PureTek Corporation CAPSICUM OLEORESIN .25 mg/mL N 20181231 59088-333_1c3059c5-5f7d-264e-e054-00144ff8d46c 59088-333 HUMAN OTC DRUG Skin Repair Complex Dimethicone CREAM TOPICAL 20150501 OTC MONOGRAPH FINAL part347 PureTek Corporation DIMETHICONE 50 mg/mL N 20181231 59088-334_dbd58f5f-aa96-4203-8a29-de2be8ded6cb 59088-334 HUMAN PRESCRIPTION DRUG DermacinRx Surgical ComboPak Chlorhexidine Gluconate Surgical Combo Kit KIT 20150428 NDA NDA019125 PureTek Corporation N 20181231 59088-336_ed2e6e91-25a7-4880-a07d-e20e55d85bee 59088-336 HUMAN PRESCRIPTION DRUG DermacinRx SilaPak Triamcinolone Acetonide Cream, Dimethicone Cream KIT 20150623 ANDA ANDA088042 PureTek Corporation N 20181231 59088-343_135534dc-5fa0-4208-a234-a9873d67356e 59088-343 HUMAN PRESCRIPTION DRUG DermacinRx Lexitral PharmaPak diclofenac sodium, capsaicin KIT 20151106 ANDA ANDA202769 PureTek Corporation N 20181231 59088-351_8a1821fd-595e-488f-a3e6-4eca10bf7188 59088-351 HUMAN PRESCRIPTION DRUG DermacinRx Cinlone-I CPI lidocaine and prilocaine, triamcinolone acetonide KIT 20160517 ANDA ANDA076453 PureTek Corporation N 20181231 59088-352_0623c309-d910-497d-a356-b249c9ab0476 59088-352 HUMAN PRESCRIPTION DRUG DermacinRx Cinlone-II CPI lidocaine and prilocaine, triamcinolone acetonide KIT 20160624 ANDA ANDA076453 PureTek Corporation N 20181231 59088-353_1e969c5d-d9e1-4a3f-a707-f8eff758f69f 59088-353 HUMAN PRESCRIPTION DRUG DermacinRx Surgical PharmaPak Mupirocin Ointment Kit KIT 20150827 ANDA ANDA065123 PureTek Corporation N 20181231 59088-363_c1f9b022-f392-4ff9-94e7-696a5fa39c13 59088-363 HUMAN PRESCRIPTION DRUG DermacinRx Silazone Pak Triamcinolone Acetonide KIT 20151210 ANDA ANDA088042 PureTek Corporation N 20181231 59088-365_e6da086e-03ba-49c7-94ea-b798cf46c1f1 59088-365 HUMAN PRESCRIPTION DRUG Xrylix Diclofenac Sodium KIT 20160301 ANDA ANDA202769 PureTek Corporation N 20181231 59088-367_bca11666-cc3b-4019-b721-a178f505e090 59088-367 HUMAN PRESCRIPTION DRUG DermacinRx SilaPak Triamcinolone Acetonide Cream Kit KIT 20150818 ANDA ANDA088042 PureTek Corporation N 20181231 59088-371_09441b74-f923-4c5d-8ca5-cdf1cd8ccb51 59088-371 HUMAN PRESCRIPTION DRUG DermacinRx Lidotral Lidocaine Hydrochloride CREAM TOPICAL 20151203 UNAPPROVED DRUG OTHER PureTek Corporation LIDOCAINE HYDROCHLORIDE 38.8 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 59088-372_4a06e902-521d-436b-bd51-43e34f39f3c1 59088-372 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20151104 ANDA ANDA202769 PureTek Corporation DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 59088-375_23010f6b-99a6-4833-9300-21c428f7784f 59088-375 HUMAN PRESCRIPTION DRUG Klofensaid II Diclofenac Sodium SOLUTION TOPICAL 20160301 ANDA ANDA202769 PureTek Corporation DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59088-378_3f97c0a5-c200-4cc1-8af4-c9d74d42ecf5 59088-378 HUMAN PRESCRIPTION DRUG Venipuncture CPI lidocaine and prilocaine KIT 20160509 ANDA ANDA076453 PureTek Corporation N 20181231 59088-391_4921fe39-f86c-4723-98d2-cde68dbae88a 59088-391 HUMAN PRESCRIPTION DRUG DermacinRx Clorhexacin Mupirocin Ointment KIT 20160602 ANDA ANDA065123 PureTek Corporation N 20181231 59088-392_a92e622f-ee12-40a7-9d84-d4d737f1caa8 59088-392 HUMAN PRESCRIPTION DRUG Ticanase Fluticasone Propionate KIT 20160111 ANDA ANDA077538 PureTek Corporation N 20181231 59088-393_594b8ccd-27de-4203-ab1c-d9a284679b99 59088-393 HUMAN PRESCRIPTION DRUG Silazone-II Triamcinolone Acetonide KIT 20160120 ANDA ANDA088042 PureTek Corporation N 20181231 59088-396_a5e879b2-265e-459a-8f59-88165b0faeb6 59088-396 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine PATCH CUTANEOUS 20160229 ANDA ANDA200675 PureTek Corporation LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 59088-543_cc97b2a3-19d0-4e18-a410-1df167aa70e4 59088-543 HUMAN OTC DRUG GenRx All Purpose Cleansing Benzalkonium Chloride SPRAY TOPICAL 20130108 OTC MONOGRAPH NOT FINAL part333E PureTek Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59088-563_a1af6b8a-0a3d-40d3-8940-782922fe0643 59088-563 HUMAN OTC DRUG DermacinRx Zinc Oxide Skin Healing Zinc Oxide PASTE TOPICAL 20160803 OTC MONOGRAPH FINAL part347 PureTek Corporation ZINC OXIDE 200 mg/g N 20181231 59088-568_758a637d-10f4-47db-87c2-705dbc593758 59088-568 HUMAN OTC DRUG DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen avobenzone, octinoxate, octisalate, titanium dioxide LOTION TOPICAL 20170216 OTC MONOGRAPH FINAL part352 PureTek Corporation AVOBENZONE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 25; 30; 30; 12.5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 59088-587_2944d7fe-7977-45ed-9212-261c4fb84d1a 59088-587 HUMAN OTC DRUG PharmapureRx Menthotral lidocaine, menthol CREAM TOPICAL 20170803 UNAPPROVED DRUG OTHER PureTek Corporation LIDOCAINE HYDROCHLORIDE ANHYDROUS; MENTHOL 38.8; 30 mg/mL; mg/mL N 20181231 59088-594_cb49548e-3daa-4e7b-8afe-c0df8ad32cf2 59088-594 HUMAN PRESCRIPTION DRUG PharmapureRx Lidocaine HCl 4.12% Lidocaine Hydrochloride CREAM TOPICAL 20171002 UNAPPROVED DRUG OTHER PureTek Corporation LIDOCAINE HYDROCHLORIDE 41.2 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 59088-644_1158f1d3-d33f-4f63-9323-e35237962fcb 59088-644 HUMAN OTC DRUG GenRx All Purpose Cleansing Dimethicone LOTION TOPICAL 20130108 OTC MONOGRAPH FINAL part347 PureTek Corporation DIMETHICONE 17.5 mg/mL N 20181231 59088-663_006f721b-ed15-4642-b6ee-2bd870d60538 59088-663 HUMAN OTC DRUG GenRx Ultra Therapeutic Skin Repairing Dimethicone CREAM TOPICAL 20130108 OTC MONOGRAPH FINAL part347 PureTek Corporation DIMETHICONE 50 mg/mL N 20181231 59088-701_eebe4f3d-a8d5-496d-95f3-47a410a492f9 59088-701 HUMAN PRESCRIPTION DRUG PharmapureRx ESOMEP-EZS esomeprazole magnesium KIT 20170726 ANDA ANDA078003 PureTek Corporation N 20181231 59088-703_b09c5f97-9217-4bda-ba02-695a33d88ad2 59088-703 HUMAN PRESCRIPTION DRUG PharmapureRx IBU 600-EZS ibuprofen KIT 20170823 ANDA ANDA075682 PureTek Corporation N 20181231 59088-704_04d0f334-9ffa-4141-b567-97acb1bf642f 59088-704 HUMAN PRESCRIPTION DRUG Leximenth diclofenac sodium, lidocaine, menthol KIT 20171030 ANDA ANDA202769 PureTek Corporation N 20181231 59088-705_1f10a081-e84e-4a77-8c2f-c827e820a319 59088-705 HUMAN PRESCRIPTION DRUG Prizotral lidocaine and prilocaine, lidocaine hydrochloride KIT 20171221 NDA AUTHORIZED GENERIC NDA019941 PureTek Corporation N 20181231 59088-706_4e44b26c-6689-4ff2-89aa-d289ab90ecb9 59088-706 HUMAN PRESCRIPTION DRUG Nuvakaan lidocaine and prilocaine KIT 20171220 NDA AUTHORIZED GENERIC NDA019941 PureTek Corporation N 20181231 59088-737_653db302-c39a-47cd-9a1f-575eb5f4965d 59088-737 HUMAN OTC DRUG Dermalogica Oil Control Salicylic Acid LOTION TOPICAL 20031117 OTC MONOGRAPH FINAL part333D PureTek Corporation SALICYLIC ACID 10 uL/mL N 20181231 59088-740_63030485-b4fb-4759-ba7a-3e94fbe8fcdb 59088-740 HUMAN OTC DRUG Body Essence Raspberry Antibacterial Triclosan LOTION TOPICAL 20091228 OTC MONOGRAPH NOT FINAL part333A PureTek Corporation TRICLOSAN 1.7 uL/mL N 20181231 59088-746_8f117e1c-6634-4c23-88eb-f13592490b93 59088-746 HUMAN OTC DRUG GenRx Daily Defense Antifungal Miconazole Nitrate CREAM TOPICAL 20130108 OTC MONOGRAPH FINAL part333C PureTek Corporation MICONAZOLE NITRATE 20 mg/mL N 20181231 59088-771_11797eb7-f6f4-4b78-a6f9-4f35104ca537 59088-771 HUMAN PRESCRIPTION DRUG Lidocaine HCl - Hydrocortisone Acetate Lidocaine HCl and Hydrocortisone Acetate CREAM RECTAL 20110701 UNAPPROVED DRUG OTHER PureTek Corporation LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 30; 10 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59088-800_084b1719-5104-4e8a-9f32-1542a11f07f5 59088-800 HUMAN PRESCRIPTION DRUG Tretinopak tretinoin, avobenzone, octinoxate, octisalate and titanium dioxide KIT 20170306 NDA AUTHORIZED GENERIC NDA020404 PureTek Corporation N 20181231 59088-810_efdf9ccb-fa7b-4eb6-afb1-013d823bf8fc 59088-810 HUMAN PRESCRIPTION DRUG DermacinRx Empricaine lidocaine and prilocaine KIT 20160802 NDA AUTHORIZED GENERIC NDA019941 PureTek Corporation N 20181231 59088-811_973787cf-5ff5-4b85-84b5-a58f17a4e2bb 59088-811 HUMAN PRESCRIPTION DRUG DermacinRx Lido V Pak Lidocaine KIT TOPICAL 20160922 ANDA ANDA205318 PureTek Corporation N 20181231 59088-816_a504c83a-356b-4c73-843e-1f95e4bbe8ca 59088-816 HUMAN PRESCRIPTION DRUG Lidocaine HCl - Hydrocortisone Acetate Lidocaine HCl and Hydrocortisone Acetate CREAM RECTAL 20110701 UNAPPROVED DRUG OTHER PureTek Corporation LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 20; 20 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59088-817_e97e7fef-59af-43c7-b92e-246f62239527 59088-817 HUMAN PRESCRIPTION DRUG Lidocaine HCl - Hydrocortisone Acetate with Aloe Lidocaine HCl and Hydrocortisone Acetate GEL RECTAL 20110701 UNAPPROVED DRUG OTHER PureTek Corporation LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 28; 5.5 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59088-819_475a49ee-6d5f-688a-e054-00144ff8d46c 59088-819 HUMAN PRESCRIPTION DRUG Lidocaine HCl - Hydrocortisone Acetate Lidocaine HCl and Hydrocortisone Acetate CREAM RECTAL; TOPICAL 20110701 UNAPPROVED DRUG OTHER PureTek Corporation LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 30; 5 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59088-829_a86e83e1-1d8a-41a2-a452-aa3e5635a04c 59088-829 HUMAN OTC DRUG GenRx Daily Defense Skin Repairing Dimethicone CREAM TOPICAL 20130108 OTC MONOGRAPH FINAL part347 PureTek Corporation DIMETHICONE 17.5 mg/mL N 20181231 59088-838_ea673c0d-a8a4-419b-84d7-bf77f20753f5 59088-838 HUMAN PRESCRIPTION DRUG Lidocaine HCl - Hydrocortisone Acetate Lidocaine HCl and Hydrocortisone Acetate GEL RECTAL 20110622 UNAPPROVED DRUG OTHER PureTek Corporation LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 30; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59088-839_b3cc088c-de49-4908-87e0-82eb47eaa5f5 59088-839 HUMAN PRESCRIPTION DRUG Poly-Prep bisacodyl, polyethylene glycol, lidocaine hcl and hydrocortisone acetate KIT 20170110 ANDA ANDA077893 PureTek Corporation N 20181231 59088-841_f939a08d-39fb-493d-bc9e-8b552217378b 59088-841 HUMAN PRESCRIPTION DRUG Treziopak triamcinolone acetonide KIT 20161205 ANDA ANDA205373 PureTek Corporation N 20181231 59088-843_80b044c7-73b8-43e5-92d0-05ff3557ff0a 59088-843 HUMAN PRESCRIPTION DRUG Juulissa Pharmapak triamcinolone acetonide KIT 20161228 ANDA ANDA205373 PureTek Corporation N 20181231 59088-846_0a7bb8c2-ecb5-4a80-9993-2c73d66b4e8d 59088-846 HUMAN PRESCRIPTION DRUG Ellzia Pak triamcinolone acetonide, dimethicone KIT 20161229 ANDA ANDA205373 PureTek Corporation N 20181231 59088-851_b0b80ff7-70de-4525-88e3-8f2a780999c6 59088-851 HUMAN OTC DRUG GenRx Skin Barrier Dimethicone CREAM TOPICAL 20130108 OTC MONOGRAPH FINAL part347 PureTek Corporation DIMETHICONE 15 mg/mL N 20181231 59088-852_ca3e9b75-b2cb-47c7-8a57-af14be93351d 59088-852 HUMAN OTC DRUG GenRx Cala Zinc Skin Healing Zinc Oxide PASTE TOPICAL 20130108 OTC MONOGRAPH FINAL part347 PureTek Corporation ZINC OXIDE 200 mg/mL N 20181231 59088-856_b03f7a42-b355-4aaa-934c-0c077e325a44 59088-856 HUMAN OTC DRUG Dynamic Skin Recovery SPF30 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 PureTek Corporation AVOBENZONE; OCTINOXATE; OXYBENZONE; OCTISALATE 30; 75; 5; 5 uL/mL; uL/mL; uL/mL; uL/mL N 20181231 59088-873_fb4c8e46-249d-4b54-93c9-fe8479d9651b 59088-873 HUMAN PRESCRIPTION DRUG DermacinRx Prizopak lidocaine and prilocaine KIT 20160519 NDA AUTHORIZED GENERIC NDA019941 PureTek Corporation N 20181231 59088-893_b12cbf2e-5cf4-47e9-bc73-9e644a1a4bde 59088-893 HUMAN PRESCRIPTION DRUG DermacinRx Therazole Pak clotrimazole and betamethasone dipropionate, zinc oxide KIT 20160809 ANDA ANDA076002 PureTek Corporation N 20181231 59088-924_177cae4b-4ef0-413a-9096-0541d3991678 59088-924 HUMAN OTC DRUG GenRx Daily Defense Antifungal Miconazole Nitrate POWDER TOPICAL 20130108 OTC MONOGRAPH FINAL part333C PureTek Corporation MICONAZOLE NITRATE 20 mg/g N 20181231 59088-942_9b7bf211-ba2b-4eb9-90aa-424cb523302f 59088-942 HUMAN OTC DRUG Dermectin Sunscreen Broad Spectrum SPF 30 Titanium Dioxide CREAM TOPICAL 20110712 OTC MONOGRAPH NOT FINAL part352 PureTek Corporation TITANIUM DIOXIDE 71 uL/mL N 20181231 59088-954_eb085e50-92cd-4c95-ac02-f4985d896af7 59088-954 HUMAN OTC DRUG MyoRx Low Dose Pain Relieving Menthol CREAM TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part348 PureTek Corporation MENTHOL 5 uL/mL N 20181231 59088-962_c0c8f8ac-76e9-4b8f-ac80-204b4fe8c576 59088-962 HUMAN OTC DRUG MyoRx Pain Relieving Menthol CREAM TOPICAL 20100128 OTC MONOGRAPH NOT FINAL part348 PureTek Corporation MENTHOL 20 uL/mL N 20181231 59088-997_80faac90-35cc-4535-b11e-475f41b7dccf 59088-997 HUMAN PRESCRIPTION DRUG Lidocaine HCl Lidocaine HCl CREAM TOPICAL 20110613 UNAPPROVED DRUG OTHER PureTek Corporation LIDOCAINE HYDROCHLORIDE 30 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 59091-2001_45f1c301-e6f1-6fad-e054-00144ff88e88 59091-2001 HUMAN OTC DRUG Dr. Super Khan MILK THISTLE CAPSULE ORAL 20130705 UNAPPROVED DRUG OTHER HLscience Co Ltd MILK THISTLE 260 mg/1 N 20181231 59091-3001_45f101ad-8fb5-6779-e054-00144ff88e88 59091-3001 HUMAN OTC DRUG Dr Circu One GINKGO TABLET ORAL 20150923 UNAPPROVED DRUG OTHER HLscience Co Ltd GINKGO 24 g/100g N 20181231 59091-4001_45f1c301-e6fb-6fad-e054-00144ff88e88 59091-4001 HUMAN OTC DRUG RED CLEO POMEGRANATE JELLY ORAL 20160405 UNAPPROVED DRUG OTHER HLscience Co Ltd POMEGRANATE 44.335 g/100g N 20181231 59091-5001_45f0f0c9-1a3f-186a-e054-00144ff8d46c 59091-5001 HUMAN OTC DRUG Doctor Super Lutein LUTEIN CAPSULE ORAL 20160130 UNAPPROVED DRUG OTHER HLscience Co Ltd LUTEIN 20 g/100g N 20181231 59092-001_b784f5ff-a1e0-40d4-8367-51936a7b8c66 59092-001 HUMAN OTC DRUG Arthritis Pain Reliever capsaicin CREAM TOPICAL 20140119 OTC MONOGRAPH NOT FINAL part348 HPI Health Products Inc. CAPSAICIN .25 mg/mL E 20171231 59092-002_d2e78b92-e128-4286-bee9-a3b458ca5f6a 59092-002 HUMAN OTC DRUG Extra Strength Pain Reliever capsaicin and menthol, unspecified form CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part348 HPI Health Products Inc. CAPSAICIN; MENTHOL, UNSPECIFIED FORM .35; 30 mg/mL; mg/mL E 20171231 59105-001_28039dee-1083-4f3f-9b0e-fb110e100008 59105-001 HUMAN OTC DRUG ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20130820 OTC MONOGRAPH NOT FINAL part343 J.P. BUSINESS ENTERPRISE ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 59105-002_ab71fcc6-f102-4f69-9260-6502790cf34e 59105-002 HUMAN OTC DRUG IBUPROFEN IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20130820 ANDA ANDA079205 J.P BUSINESS ENTERPRISE IBUPROFEN 200 mg/1 N 20181231 59105-003_903b78b4-e647-481e-8c57-aeb1cef51804 59105-003 HUMAN OTC DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130820 ANDA ANDA090545 J.P. BUSINESS ENTERPRISE NAPROXEN SODIUM 220 mg/1 N 20181231 59105-004_f5c29029-dfaa-4d46-a2ac-72da0befb060 59105-004 HUMAN OTC DRUG ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20141201 OTC MONOGRAPH NOT FINAL part343 J.P. BUSINESS ENTERPRISE ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 325; 5; 10 mg/1; mg/1; mg/1 N 20181231 59105-005_15792cd7-318f-4cd8-8d58-af5900946a01 59105-005 HUMAN OTC DRUG ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE and DOXYLAMINE SUCCINATE ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20141201 OTC MONOGRAPH NOT FINAL part343 J.P. BUSINESS ENTERPRISE ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 59105-006_eaa9c7f8-90c1-45fa-8d2b-d528ba80cdcb 59105-006 HUMAN OTC DRUG DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20141201 OTC MONOGRAPH FINAL part341 J.P. BUSINESS ENTERPRISE DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 59105-007_4f7c90bc-6e4c-4918-8243-7621c910e051 59105-007 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20141201 OTC MONOGRAPH NOT FINAL part334 J.P. BUSINESS ENTERPRISE DOCUSATE SODIUM 100 mg/1 N 20181231 59110-051_17d98016-118d-4e1b-ab23-fcc3c6954365 59110-051 HUMAN OTC DRUG QSC ASSIST Antimicrobial Hand Cleanser Chloroxylenol LIQUID TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part333E Triple S a.k.a Standardized Sanitation Systems, Inc CHLOROXYLENOL .003 mg/mL N 20181231 59110-052_363bdbf6-4902-497d-a9c5-c8bee10858ae 59110-052 HUMAN OTC DRUG Triple S Gentle Antibacterial Cleanser Chloroxylenol LIQUID TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part333E Triple S a.k.a Standardized Sanitation Systems, Inc CHLOROXYLENOL .003 mg/mL N 20181231 59110-080_a299d7f0-6994-4718-acf2-6a1471b100d1 59110-080 HUMAN OTC DRUG QSC Antimicrobial Wash CM Chloroxylenol LIQUID TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part333E Triple S a.k.a Standardized Sanitation Systems, Inc CHLOROXYLENOL .003 mg/mL N 20181231 59110-081_3a277de2-ce1b-4a93-9933-22744ebfce08 59110-081 HUMAN OTC DRUG QSC Foam Fresh Antimicrobial Hand Chloroxylenol LIQUID TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part333E Triple S a.k.a Standardized Sanitation Systems, Inc CHLOROXYLENOL .003 mg/mL N 20181231 59110-082_776c389a-fe26-4d25-bc89-363972b089dd 59110-082 HUMAN OTC DRUG QSC TF Ambre Antibacterial Wash Chloroxylenol LIQUID TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part333E Triple S a.k.a Standardized Sanitation Systems, Inc CHLOROXYLENOL .003 mg/mL N 20181231 59110-200_37c0d8f7-1df2-4c96-abb0-9bd35e2d0f25 59110-200 HUMAN OTC DRUG HyTouch Ethyl alcohol GEL TOPICAL 20160726 OTC MONOGRAPH NOT FINAL part333E Standardized Sanitation Systems Inc ALCOHOL 69.8 mL/100mL N 20181231 59110-400_72dac905-c59f-4b11-8d74-4614633309cd 59110-400 HUMAN OTC DRUG Elevate TF Foam Skin Care Advance Antibacterial Foam Hand Cleaner Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Triple S a.k.a Standardized Sanitation Systems, Inc BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 59110-517_f166ba6a-4d24-4a37-867e-db9023af35be 59110-517 HUMAN OTC DRUG CONTROL CHLOROXYLENOL SOAP TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part333E Standardized Sanitation Systems CHLOROXYLENOL 2.5 g/1000mL E 20171231 59115-002_30bc5631-2129-45c4-a2bb-fc65bcbe9fe5 59115-002 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 19980218 ANDA ANDA074480 Hikma Pharmaceutical NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 59115-012_d52f2b34-cd2a-4ac5-b435-0b730bbf6a34 59115-012 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20030801 ANDA ANDA075890 Hikma Pharmaceutical GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 59115-013_d52f2b34-cd2a-4ac5-b435-0b730bbf6a34 59115-013 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20030801 ANDA ANDA075890 Hikma Pharmaceutical GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 59115-014_d52f2b34-cd2a-4ac5-b435-0b730bbf6a34 59115-014 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20030801 ANDA ANDA075890 Hikma Pharmaceutical GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 59115-023_0c5d814d-13ff-48a4-ada4-f07d206c4629 59115-023 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20050125 ANDA ANDA065191 Hikma Pharmaceutical AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 59115-024_0c5d814d-13ff-48a4-ada4-f07d206c4629 59115-024 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20050125 ANDA ANDA065191 Hikma Pharmaceutical AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 59115-025_493b7367-9958-4870-b60e-4c411551888f 59115-025 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET ORAL 20160823 ANDA ANDA203824 Hikma Pharmaceutical AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 59115-028_a5a5af08-2567-4696-965c-fa2e478cc0b6 59115-028 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Hikma Pharmaceutical CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 59115-029_a5a5af08-2567-4696-965c-fa2e478cc0b6 59115-029 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Hikma Pharmaceutical CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 59115-030_a5a5af08-2567-4696-965c-fa2e478cc0b6 59115-030 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Hikma Pharmaceutical CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 59115-040_c0157442-903b-49a0-a3fc-b8ca73711170 59115-040 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20060329 ANDA ANDA065255 Hikma Pharmaceutical AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 59115-041_369d1ebb-20b3-4b20-a3f5-1ee504b643af 59115-041 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070205 ANDA ANDA065291 Hikma Pharmaceutical AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 59115-042_369d1ebb-20b3-4b20-a3f5-1ee504b643af 59115-042 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20070205 ANDA ANDA065291 Hikma Pharmaceutical AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 59115-043_43603a64-325c-4c5a-b7c4-4b06d15b8c9b 59115-043 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 Hikma Pharmaceutical AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 59115-044_43603a64-325c-4c5a-b7c4-4b06d15b8c9b 59115-044 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Hikma Pharmaceutical AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 59115-045_43603a64-325c-4c5a-b7c4-4b06d15b8c9b 59115-045 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 Hikma Pharmaceutical AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 59115-046_43603a64-325c-4c5a-b7c4-4b06d15b8c9b 59115-046 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Hikma Pharmaceutical AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 59115-053_4b279cda-394a-40d3-9cd9-dd8c66d0ce4b 59115-053 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 Hikma Pharmaceutical SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 59115-054_4b279cda-394a-40d3-9cd9-dd8c66d0ce4b 59115-054 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 Hikma Pharmaceutical SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 59115-055_4b279cda-394a-40d3-9cd9-dd8c66d0ce4b 59115-055 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride sertraline hydrochloride TABLET, FILM COATED ORAL 20090810 ANDA ANDA077864 Hikma Pharmaceutical SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 59115-056_1e1780ca-5513-49a7-9ee3-f27be5b2ccce 59115-056 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20110412 ANDA ANDA077771 Hikma Pharmaceutical AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 59115-057_1e1780ca-5513-49a7-9ee3-f27be5b2ccce 59115-057 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20110412 ANDA ANDA077771 Hikma Pharmaceutical AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 59115-058_1e1780ca-5513-49a7-9ee3-f27be5b2ccce 59115-058 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20110412 ANDA ANDA077771 Hikma Pharmaceutical AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 59115-061_50d351a9-b260-4a68-bb21-1bdf4b0b0098 59115-061 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071109 ANDA ANDA065373 Hikma Pharmaceutical AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 59115-065_5a7d93d6-4858-4ef3-afe7-ea016442df5f 59115-065 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 Hikma Pharmaceutical LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 59115-066_5a7d93d6-4858-4ef3-afe7-ea016442df5f 59115-066 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 Hikma Pharmaceutical LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 59115-067_5a7d93d6-4858-4ef3-afe7-ea016442df5f 59115-067 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 Hikma Pharmaceutical LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 59115-068_5a7d93d6-4858-4ef3-afe7-ea016442df5f 59115-068 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110419 ANDA ANDA078134 Hikma Pharmaceutical LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 59115-069_67cd82f2-e6a0-4db1-8c35-0f5524bc1712 59115-069 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20080404 ANDA ANDA090543 Hikma Pharmaceutical MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 59115-070_67cd82f2-e6a0-4db1-8c35-0f5524bc1712 59115-070 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20080404 ANDA ANDA090543 Hikma Pharmaceutical MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 59115-073_e4d350e8-da9f-41f6-be75-353e33ee8463 59115-073 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 Hikma Pharmaceutical GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 59115-074_e4d350e8-da9f-41f6-be75-353e33ee8463 59115-074 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 Hikma Pharmaceutical GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 59115-075_e4d350e8-da9f-41f6-be75-353e33ee8463 59115-075 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 Hikma Pharmaceutical GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 59115-088_58f355ed-cb9c-4c8b-9e92-e38036d4d5d5 59115-088 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090601 ANDA ANDA078740 Hikma Pharmaceutical RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] E 20171231 59115-089_58f355ed-cb9c-4c8b-9e92-e38036d4d5d5 59115-089 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090601 ANDA ANDA078740 Hikma Pharmaceutical RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] E 20171231 59115-090_58f355ed-cb9c-4c8b-9e92-e38036d4d5d5 59115-090 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090601 ANDA ANDA078740 Hikma Pharmaceutical RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 59115-091_58f355ed-cb9c-4c8b-9e92-e38036d4d5d5 59115-091 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090601 ANDA ANDA078740 Hikma Pharmaceutical RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 59115-092_58f355ed-cb9c-4c8b-9e92-e38036d4d5d5 59115-092 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090601 ANDA ANDA078740 Hikma Pharmaceutical RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 59115-093_58f355ed-cb9c-4c8b-9e92-e38036d4d5d5 59115-093 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090601 ANDA ANDA078740 Hikma Pharmaceutical RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] E 20171231 59115-094_b12e5223-390a-46b2-a29b-bbc6a704080a 59115-094 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20100816 ANDA ANDA078599 Hikma Pharmaceutical GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 59115-095_9efe5654-c187-4c9a-a702-2317f5600b6d 59115-095 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110621 ANDA ANDA078767 Hikma Pharmaceutical LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 59115-096_9efe5654-c187-4c9a-a702-2317f5600b6d 59115-096 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110621 ANDA ANDA078767 Hikma Pharmaceutical LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 59115-097_9efe5654-c187-4c9a-a702-2317f5600b6d 59115-097 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110621 ANDA ANDA078767 Hikma Pharmaceutical LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 59115-100_3b4a1c2f-5dcc-4530-9243-86657c940c0b 59115-100 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 Hikma Pharmaceutical ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 59115-101_3b4a1c2f-5dcc-4530-9243-86657c940c0b 59115-101 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 Hikma Pharmaceutical ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 59115-102_3b4a1c2f-5dcc-4530-9243-86657c940c0b 59115-102 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 Hikma Pharmaceutical ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 59115-109_cbcb547e-f9ad-498e-ab84-42b17796174e 59115-109 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090247 Hikma Pharmaceutical DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 59115-110_cbcb547e-f9ad-498e-ab84-42b17796174e 59115-110 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090247 Hikma Pharmaceutical DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 59115-117_bda30ec5-00b6-4626-b9dc-77de1d428425 59115-117 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20160110 ANDA ANDA090549 Hikma Pharmaceutical PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 59115-118_bda30ec5-00b6-4626-b9dc-77de1d428425 59115-118 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20160110 ANDA ANDA090549 Hikma Pharmaceutical PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 59115-122_479115c6-bb13-4266-ba6a-be4f58657c86 59115-122 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Capsules Doxycycline Hyclate CAPSULE ORAL 19900901 ANDA ANDA062396 Hikma Pharmaceutical DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 59115-123_479115c6-bb13-4266-ba6a-be4f58657c86 59115-123 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Capsules Doxycycline Hyclate CAPSULE ORAL 19900901 ANDA ANDA062396 Hikma Pharmaceutical DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 59115-129_7bd8087a-3345-4959-8e53-588ea1782bda 59115-129 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086066 Hikma Pharmaceutical ISOSORBIDE DINITRATE 10 mg/1 N 20181231 59115-130_7bd8087a-3345-4959-8e53-588ea1782bda 59115-130 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19830426 ANDA ANDA088088 Hikma Pharmaceutical ISOSORBIDE DINITRATE 20 mg/1 N 20181231 59115-135_31eb6bc4-6f4d-418b-a9f5-081f6140063e 59115-135 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20020627 ANDA ANDA076243 Hikma Pharmaceutical LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 59115-139_b911f5f3-484f-4103-84f4-c12158d9982b 59115-139 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19720522 ANDA ANDA080292 Hikma Pharmaceutical PREDNISONE 5 mg/1 N 20181231 59115-140_b911f5f3-484f-4103-84f4-c12158d9982b 59115-140 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19851204 ANDA ANDA088832 Hikma Pharmaceutical PREDNISONE 10 mg/1 N 20181231 59115-141_b911f5f3-484f-4103-84f4-c12158d9982b 59115-141 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19740226 ANDA ANDA083677 Hikma Pharmaceutical PREDNISONE 20 mg/1 N 20181231 59115-143_7bd8087a-3345-4959-8e53-588ea1782bda 59115-143 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086067 Hikma Pharmaceutical ISOSORBIDE DINITRATE 5 mg/1 N 20181231 59115-144_c890ad0f-6b61-4304-9fca-d823d5ecc11e 59115-144 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130822 ANDA ANDA076063 Hikma Pharmaceutical LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 59115-145_c890ad0f-6b61-4304-9fca-d823d5ecc11e 59115-145 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130822 ANDA ANDA076063 Hikma Pharmaceutical LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 59115-146_c890ad0f-6b61-4304-9fca-d823d5ecc11e 59115-146 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130822 ANDA ANDA076063 Hikma Pharmaceutical LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 59115-147_c890ad0f-6b61-4304-9fca-d823d5ecc11e 59115-147 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130822 ANDA ANDA076063 Hikma Pharmaceutical LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 59115-161_0a3a1df5-b106-4f1e-8f25-6683f0f31ca3 59115-161 HUMAN PRESCRIPTION DRUG CORTISONE ACETATE CORTISONE ACETATE TABLET ORAL 20130826 ANDA ANDA080776 Hikma Pharmaceutical CORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59118-837_55c55f1c-d2b4-6363-e054-00144ff88e88 59118-837 HUMAN OTC DRUG Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part348 Rexall Sundown, LLC MENTHOL; METHYL SALICYLATE 50; 100 mg/g; mg/g N 20181231 59137-505_4abcf61c-a8ba-4b64-bb9e-662ff36033a4 59137-505 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 7.5 mg/.15mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 59137-510_4abcf61c-a8ba-4b64-bb9e-662ff36033a4 59137-510 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 10 mg/.2mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 59137-515_4abcf61c-a8ba-4b64-bb9e-662ff36033a4 59137-515 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 12.5 mg/.25mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 59137-520_4abcf61c-a8ba-4b64-bb9e-662ff36033a4 59137-520 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 15 mg/.3mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 59137-525_4abcf61c-a8ba-4b64-bb9e-662ff36033a4 59137-525 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 17.5 mg/.35mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 59137-530_4abcf61c-a8ba-4b64-bb9e-662ff36033a4 59137-530 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 20 mg/.4mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 59137-535_4abcf61c-a8ba-4b64-bb9e-662ff36033a4 59137-535 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 22.5 mg/.45mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 59137-540_4abcf61c-a8ba-4b64-bb9e-662ff36033a4 59137-540 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 25 mg/.5mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 59137-550_4abcf61c-a8ba-4b64-bb9e-662ff36033a4 59137-550 HUMAN PRESCRIPTION DRUG Rasuvo methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20140710 NDA NDA205776 Medac Pharma, Inc METHOTREXATE SODIUM 30 mg/.6mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 59138-002_0528de0e-bd71-4e42-8161-0f1d6b1d1d28 59138-002 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS Gulf Medical Services, Inc. OXYGEN 99 L/100L N 20181231 59139-0002_462a59fb-8975-4482-af90-7f2248ce0077 59139-0002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070921 UNAPPROVED MEDICAL GAS Grandview Hospital DBA Grandview Medical Company OXYGEN 99 L/100L E 20171231 59145-773_ab6768b1-ade4-48da-96b7-607fd25d2b69 59145-773 HUMAN OTC DRUG Anti Aging SPF Moistruizer Avobenzone, Homosalate, Octisalate, Octinoxate CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Twinluxe,LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTINOXATE .025; .05; .05; .07 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 59148-006_855b67cc-5a4a-4b83-b9cd-e9c6d220bfc5 59148-006 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-007_855b67cc-5a4a-4b83-b9cd-e9c6d220bfc5 59148-007 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-008_855b67cc-5a4a-4b83-b9cd-e9c6d220bfc5 59148-008 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-009_855b67cc-5a4a-4b83-b9cd-e9c6d220bfc5 59148-009 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-010_855b67cc-5a4a-4b83-b9cd-e9c6d220bfc5 59148-010 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-011_855b67cc-5a4a-4b83-b9cd-e9c6d220bfc5 59148-011 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-013_855b67cc-5a4a-4b83-b9cd-e9c6d220bfc5 59148-013 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE SOLUTION ORAL 20041210 NDA NDA021713 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 59148-016_855b67cc-5a4a-4b83-b9cd-e9c6d220bfc5 59148-016 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE INJECTION, SOLUTION INTRAMUSCULAR 20060920 NDA NDA021866 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 9.75 mg/1.3mL Atypical Antipsychotic [EPC] N 20181231 59148-018_3687d391-4e13-4449-ba3b-a92d99201e99 59148-018 HUMAN PRESCRIPTION DRUG ABILIFY MAINTENA aripiprazole KIT 20130228 NDA NDA202971 Otsuka America Pharmaceutical, Inc. N 20181231 59148-019_3687d391-4e13-4449-ba3b-a92d99201e99 59148-019 HUMAN PRESCRIPTION DRUG ABILIFY MAINTENA aripiprazole KIT 20130228 NDA NDA202971 Otsuka America Pharmaceutical, Inc. N 20181231 59148-020_fd141765-4d48-4b7e-aed1-3f2a72713c47 59148-020 HUMAN PRESCRIPTION DRUG SAMSCA tolvaptan TABLET ORAL 20090519 NDA NDA022275 Otsuka America Pharmaceutical, Inc. TOLVAPTAN 15 mg/1 Vasopressin V2 Receptor Antagonist [EPC],Vasopressin V2 Receptor Antagonists [MoA] N 20181231 59148-021_fd141765-4d48-4b7e-aed1-3f2a72713c47 59148-021 HUMAN PRESCRIPTION DRUG SAMSCA tolvaptan TABLET ORAL 20090519 NDA NDA022275 Otsuka America Pharmaceutical, Inc. TOLVAPTAN 30 mg/1 Vasopressin V2 Receptor Antagonist [EPC],Vasopressin V2 Receptor Antagonists [MoA] N 20181231 59148-029_5414cf9d-c5b5-48ea-9c96-5d91fce901c3 59148-029 HUMAN PRESCRIPTION DRUG Abilify MyCite ARIPIPRAZOLE TABLET ORAL 20180131 NDA NDA207202 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-030_5414cf9d-c5b5-48ea-9c96-5d91fce901c3 59148-030 HUMAN PRESCRIPTION DRUG Abilify MyCite ARIPIPRAZOLE TABLET ORAL 20180131 NDA NDA207202 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-031_5414cf9d-c5b5-48ea-9c96-5d91fce901c3 59148-031 HUMAN PRESCRIPTION DRUG Abilify MyCite ARIPIPRAZOLE TABLET ORAL 20180131 NDA NDA207202 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-032_5414cf9d-c5b5-48ea-9c96-5d91fce901c3 59148-032 HUMAN PRESCRIPTION DRUG Abilify MyCite ARIPIPRAZOLE TABLET ORAL 20180131 NDA NDA207202 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-033_5414cf9d-c5b5-48ea-9c96-5d91fce901c3 59148-033 HUMAN PRESCRIPTION DRUG Abilify MyCite ARIPIPRAZOLE TABLET ORAL 20180131 NDA NDA207202 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-034_5414cf9d-c5b5-48ea-9c96-5d91fce901c3 59148-034 HUMAN PRESCRIPTION DRUG Abilify MyCite ARIPIPRAZOLE TABLET ORAL 20180131 NDA NDA207202 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-035_9d263d31-21bf-4b5d-8893-b7ccc3c3fe0c 59148-035 HUMAN PRESCRIPTION DRUG REXULTI brexpiprazole TABLET ORAL 20150710 NDA NDA205422 Otsuka America Pharmaceutical, Inc. BREXPIPRAZOLE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-036_9d263d31-21bf-4b5d-8893-b7ccc3c3fe0c 59148-036 HUMAN PRESCRIPTION DRUG REXULTI brexpiprazole TABLET ORAL 20150710 NDA NDA205422 Otsuka America Pharmaceutical, Inc. BREXPIPRAZOLE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-037_9d263d31-21bf-4b5d-8893-b7ccc3c3fe0c 59148-037 HUMAN PRESCRIPTION DRUG REXULTI brexpiprazole TABLET ORAL 20150710 NDA NDA205422 Otsuka America Pharmaceutical, Inc. BREXPIPRAZOLE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-038_9d263d31-21bf-4b5d-8893-b7ccc3c3fe0c 59148-038 HUMAN PRESCRIPTION DRUG REXULTI brexpiprazole TABLET ORAL 20150710 NDA NDA205422 Otsuka America Pharmaceutical, Inc. BREXPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-039_9d263d31-21bf-4b5d-8893-b7ccc3c3fe0c 59148-039 HUMAN PRESCRIPTION DRUG REXULTI brexpiprazole TABLET ORAL 20150710 NDA NDA205422 Otsuka America Pharmaceutical, Inc. BREXPIPRAZOLE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-040_9d263d31-21bf-4b5d-8893-b7ccc3c3fe0c 59148-040 HUMAN PRESCRIPTION DRUG REXULTI brexpiprazole TABLET ORAL 20150710 NDA NDA205422 Otsuka America Pharmaceutical, Inc. BREXPIPRAZOLE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-045_3687d391-4e13-4449-ba3b-a92d99201e99 59148-045 HUMAN PRESCRIPTION DRUG ABILIFY MAINTENA aripiprazole KIT 20141008 NDA NDA202971 Otsuka America Pharmaceutical, Inc. N 20181231 59148-046_f5bf945d-8976-4c38-ba0d-4ac9b6770849 59148-046 HUMAN PRESCRIPTION DRUG Dacogen decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960503 NDA NDA021790 Otsuka America Pharmaceutical, Inc. DECITABINE 50 mg/20mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 59148-047_950276f8-8e33-4dff-998d-7b66ace11aaf 59148-047 HUMAN PRESCRIPTION DRUG BUSULFEX busulfan INJECTION INTRAVENOUS 20150213 NDA NDA020954 Otsuka America Pharmaceutical, Inc. BUSULFAN 6 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 59148-070_9875bb33-35b8-4582-8458-ef62489e0538 59148-070 HUMAN PRESCRIPTION DRUG BUSULFEX busulfan INJECTION INTRAVENOUS 19990204 NDA NDA020954 Otsuka America Pharmaceutical, Inc. BUSULFAN 6 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 59148-072_3687d391-4e13-4449-ba3b-a92d99201e99 59148-072 HUMAN PRESCRIPTION DRUG ABILIFY MAINTENA aripiprazole KIT 20141008 NDA NDA202971 Otsuka America Pharmaceutical, Inc. N 20181231 59148-640_855b67cc-5a4a-4b83-b9cd-e9c6d220bfc5 59148-640 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING ORAL 20060607 NDA NDA021729 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 59148-641_855b67cc-5a4a-4b83-b9cd-e9c6d220bfc5 59148-641 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING ORAL 20060607 NDA NDA021729 Otsuka America Pharmaceutical, Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 59151-645_3c4a53a1-c856-382d-e054-00144ff88e88 59151-645 HUMAN OTC DRUG Skin and scalp COAL TAR SHAMPOO TOPICAL 20160901 OTC MONOGRAPH FINAL part358H Albra Dewyn LLC COAL TAR 17 mg/mL E 20171231 59151-645_40c0958a-2be9-5bab-e054-00144ff88e88 59151-645 HUMAN OTC DRUG Skin and scalp COAL TAR SHAMPOO TOPICAL 20160901 OTC MONOGRAPH FINAL part358H Albra Dewyn LLC COAL TAR 17 mg/mL E 20171231 59151-646_3e9b8d74-2810-5637-e054-00144ff88e88 59151-646 HUMAN OTC DRUG Skin and Scalp Body COAL TAR LOTION TOPICAL 20161003 OTC MONOGRAPH FINAL part358H Albra Dewyn LLC COAL TAR .5 mg/mL E 20171231 59151-646_40c0ea76-9f5c-3c8b-e054-00144ff8d46c 59151-646 HUMAN OTC DRUG Skin and Scalp Body COAL TAR LOTION TOPICAL 20160901 OTC MONOGRAPH FINAL part358H Albra Dewyn LLC COAL TAR .5 mg/mL E 20171231 59158-719_32388226-7797-4ea0-8d6f-f3aa9c1b3b70 59158-719 HUMAN OTC DRUG ALL YOU NEED CONTINUOUS ACTION 24 HOUR MOISTURE SPF 15 FOR NORMAL SKIN HOMOSALATE, OCTINOXATE, AVOBENZONE LOTION TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC. HOMOSALATE; OCTINOXATE; AVOBENZONE 5; 5; 3 mL/100mL; mL/100mL; mL/100mL N 20181231 59158-723_2cbffe46-9175-45bd-9e7d-6a7f7c0b4157 59158-723 HUMAN OTC DRUG PRESCRIPTIVES ALL SKINS MINERAL MAKEUP 16 HR. SPF 10 TITANIUM DIOXIDE LIQUID TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC TITANIUM DIOXIDE 4.7 mL/100mL E 20171231 59158-731_292b6d23-8e51-4a64-964c-cf1b49b45530 59158-731 HUMAN OTC DRUG TRACELESS SKIN RESPONSIVE TINT OCTINOXATE CREAM TOPICAL 20010601 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC. OCTINOXATE 2 mL/100mL E 20171231 59158-759_67ae6048-66ac-4d96-b9dc-883948345126 59158-759 HUMAN OTC DRUG VIRTUAL SKIN SUPER NATURAL FINISH SPF 10 OCTINOXATE LIQUID TOPICAL 19990101 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC. OCTINOXATE 5.4 mL/100mL E 20171231 59158-760_c74dfeac-224f-4b11-9a4d-39d4e386486d 59158-760 HUMAN OTC DRUG FLAWLESS SKIN MAKEUP BROAD SPECTRUM SPF 15 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20041222 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .04551; .01554; .01665 g/mL; g/mL; g/mL N 20181231 59158-913_32cbe570-53c5-4835-a17c-8cea24909895 59158-913 HUMAN OTC DRUG PRESCRIPTIVES SITE UNSEEN BRIGHTENING CONCEALER BROAD SPECTRUM SPF 15 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20061116 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .04551; .01554; .01665 g/mL; g/mL; g/mL N 20181231 59158-914_ec997f74-4a04-4f65-b9fa-dc00edba452d 59158-914 HUMAN OTC DRUG FLAWLESS SKIN TOTAL PROTECTION CONCEALER SPF 25 TITANIUM DIOXIDE PASTE TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC TITANIUM DIOXIDE 4.2 g/100g N 20181231 59158-915_51a85dfa-3a72-43c4-8d2d-a01542b2999c 59158-915 HUMAN OTC DRUG VIRTUAL MATTE OIL CONTROL MAKEUP BROAD SPECTRUM SPF 15 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part352 PRESCRIPTIVES INC OCTINOXATE; TITANIUM DIOXIDE .02775; .010767 g/mL; g/mL N 20181231 59190-416_5d7b4e7c-2760-3d86-e053-2991aa0a16c7 59190-416 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030515 UNAPPROVED MEDICAL GAS Via Christi Home Medical Wichita, LLC OXYGEN 99 L/100L N 20181231 59194-001_a994ae6c-a94f-4a97-bfbf-d775e9fcdba2 59194-001 HUMAN OTC DRUG BANDAGE benzalkonium chloride SWAB TOPICAL 20130520 OTC MONOGRAPH NOT FINAL part333A Zhejiang Changdi Medical Co., Ltd. BENZALKONIUM CHLORIDE .0012 mg/mg E 20171231 59194-002_7b237437-e77b-4d7e-a9d6-f1fd7764ca1f 59194-002 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20130702 OTC MONOGRAPH NOT FINAL part333A Zhejiang Changdi Medical Co., Ltd. ALCOHOL 70 mL/100mL E 20171231 59212-001_2fa06156-4f46-468e-b1cd-4cfc16d2e7bb 59212-001 HUMAN PRESCRIPTION DRUG Dibenzyline Phenoxybenzamine Hydrochloride CAPSULE ORAL 19530126 NDA NDA008708 Concordia Pharmaceuticals Inc. PHENOXYBENZAMINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59212-002_43fc7e74-83c4-484d-b151-1924f5cf1387 59212-002 HUMAN PRESCRIPTION DRUG Dyrenium Triamterene CAPSULE ORAL 19991001 NDA NDA013174 Concordia Pharmaceuticals Inc. TRIAMTERENE 50 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 59212-003_43fc7e74-83c4-484d-b151-1924f5cf1387 59212-003 HUMAN PRESCRIPTION DRUG Dyrenium Triamterene CAPSULE ORAL 19990101 NDA NDA013174 Concordia Pharmaceuticals Inc. TRIAMTERENE 100 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 59212-075_2baa3696-97e1-4fce-aa79-d14289548ed1 59212-075 HUMAN PRESCRIPTION DRUG Kayexalate sodium polystyrene sulfonate POWDER, FOR SUSPENSION ORAL; RECTAL 20130715 20180630 NDA NDA011287 Concordia Pharmaceuticals Inc. SODIUM POLYSTYRENE SULFONATE 4.1 meq/g N 20181231 59212-087_892222ee-9da0-4337-8e10-fe95dafefded 59212-087 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET ORAL 20140701 NDA NDA021956 Concordia Pharmaceuticals Inc METOPROLOL SUCCINATE; HYDROCHLOROTHIAZIDE 25; 12.5 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 59212-095_892222ee-9da0-4337-8e10-fe95dafefded 59212-095 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET ORAL 20140701 NDA NDA021956 Concordia Pharmaceuticals Inc METOPROLOL SUCCINATE; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 59212-097_892222ee-9da0-4337-8e10-fe95dafefded 59212-097 HUMAN PRESCRIPTION DRUG Dutoprol metoprolol succinate and hydrochlorothiazide TABLET ORAL 20140701 NDA NDA021956 Concordia Pharmaceuticals Inc METOPROLOL SUCCINATE; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 59212-111_648e10b6-b7f1-4be0-9fdc-e925e9fbba65 59212-111 HUMAN PRESCRIPTION DRUG Nilandron Nilutamide TABLET ORAL 20130715 NDA NDA020169 Concordia Pharmaceuticals Inc. NILUTAMIDE 150 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 59212-200_9e101325-c980-461b-b781-190cc622fccf 59212-200 HUMAN PRESCRIPTION DRUG Uroxatral Alfuzosin HCl TABLET, EXTENDED RELEASE ORAL 20130603 NDA NDA021287 Concordia Pharmaceuticals Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59212-240_570d750c-2f48-4d80-97cf-ebd671fc8ccb 59212-240 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Concordia Pharmaceuticals Inc. DIGOXIN .0625 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 59212-242_570d750c-2f48-4d80-97cf-ebd671fc8ccb 59212-242 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Concordia Pharmaceuticals Inc. DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 59212-245_570d750c-2f48-4d80-97cf-ebd671fc8ccb 59212-245 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Concordia Pharmaceuticals Inc. DIGOXIN .1875 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 59212-249_570d750c-2f48-4d80-97cf-ebd671fc8ccb 59212-249 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Concordia Pharmaceuticals Inc. DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 59212-422_b71e06ac-cd7f-4715-a6ec-18dc87d994a5 59212-422 HUMAN PRESCRIPTION DRUG Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide ELIXIR ORAL 19801230 UNAPPROVED DRUG OTHER Concordia Pharmaceuticals Inc. PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 59212-423_b71e06ac-cd7f-4715-a6ec-18dc87d994a5 59212-423 HUMAN PRESCRIPTION DRUG Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide ELIXIR ORAL 19801230 UNAPPROVED DRUG OTHER Concordia Pharmaceuticals Inc. PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 59212-425_ccb77870-2fd7-431a-a00c-552b8c257c34 59212-425 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE TABLET ORAL 19801230 UNAPPROVED DRUG OTHER Concordia Pharmaceuticals Inc. PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 59212-447_4021e538-9f44-4e67-bef6-dc325a6d0755 59212-447 HUMAN PRESCRIPTION DRUG PARNATE tranylcypromine sulfate TABLET, FILM COATED ORAL 20130114 NDA NDA012342 Concordia Pharmaceuticals Inc. TRANYLCYPROMINE SULFATE 10 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20191231 59212-562_2f9dbc94-04c9-4499-aeab-b9ef7b92563c 59212-562 HUMAN PRESCRIPTION DRUG Plaquenil Hydroxychloroquine Sulfate TABLET ORAL 20130628 NDA NDA009768 Concordia Pharmaceuticals Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 59212-658_64129034-2836-400d-a9ed-084abbf640ab 59212-658 HUMAN PRESCRIPTION DRUG Kapvay clonidine hydrochloride TABLET, EXTENDED RELEASE ORAL 20101209 NDA NDA022331 Concordia Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 59212-659_64129034-2836-400d-a9ed-084abbf640ab 59212-659 HUMAN PRESCRIPTION DRUG Kapvay clonidine hydrochloride TABLET, EXTENDED RELEASE ORAL 20101209 NDA NDA022331 Concordia Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 59212-680_a33e18b7-8453-45c9-8bd2-957d126c7eed 59212-680 HUMAN PRESCRIPTION DRUG Zonegran zonisamide CAPSULE ORAL 20000327 NDA NDA020789 Concordia Pharmaceuticals Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 59212-681_a33e18b7-8453-45c9-8bd2-957d126c7eed 59212-681 HUMAN PRESCRIPTION DRUG Zonegran zonisamide CAPSULE ORAL 20000327 NDA NDA020789 Concordia Pharmaceuticals Inc. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 59212-700_3ff164a5-ecb8-43d5-915b-ade2b585268a 59212-700 HUMAN PRESCRIPTION DRUG Orapred ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING ORAL 20060601 NDA NDA021959 Concordia Pharmaceuticals Inc. PREDNISOLONE SODIUM PHOSPHATE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59212-701_3ff164a5-ecb8-43d5-915b-ade2b585268a 59212-701 HUMAN PRESCRIPTION DRUG Orapred ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING ORAL 20060601 NDA NDA021959 Concordia Pharmaceuticals Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59212-702_3ff164a5-ecb8-43d5-915b-ade2b585268a 59212-702 HUMAN PRESCRIPTION DRUG Orapred ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING ORAL 20060601 NDA NDA021959 Concordia Pharmaceuticals Inc. PREDNISOLONE SODIUM PHOSPHATE 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59215-6143_1eeeff83-0ac6-4823-9e9e-474e7e65d69a 59215-6143 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Lewin Medical Supply OXYGEN 99 L/100L N 20181231 59220-1001_1a9cb1a8-7647-4fcd-8251-48ff35a2184b 59220-1001 HUMAN OTC DRUG NMC Magma Mineral Pack MAGNESIUM PLASTER TOPICAL 20130708 UNAPPROVED DRUG OTHER NMC (Natural Magma Cosmetics) MAGNESIUM 3 g/100g E 20171231 59220-2001_a4eb5207-f3c5-42cd-978d-6527f8b556bb 59220-2001 HUMAN OTC DRUG NMC Magic Serum ALLANTOIN LIQUID TOPICAL 20130708 UNAPPROVED DRUG OTHER NMC (Natural Magma Cosmetics) ALLANTOIN 1 mg/30mL E 20171231 59220-3001_04e82b16-1c6e-45f8-b596-381e5dbcbea5 59220-3001 HUMAN OTC DRUG NMC Magic Serum ADENOSINE LIQUID TOPICAL 20130711 UNAPPROVED DRUG OTHER NMC (Natural Magma Cosmetics) ADENOSINE .04 mg/100mL E 20171231 59220-4001_927d3dc1-d4f8-41c6-95fe-5fa83588fcff 59220-4001 HUMAN OTC DRUG NMC Staypot double programing cream ADENOSINE LIQUID TOPICAL 20130711 UNAPPROVED DRUG OTHER NMC (Natural Magma Cosmetics) ADENOSINE .04 mg/100mL E 20171231 59225-0001_1ea1006c-a039-4309-a67a-a360a833dd12 59225-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130417 UNAPPROVED MEDICAL GAS Peachtree Medical OXYGEN 99 L/100L E 20171231 59228-103_946aca0d-8602-4fe7-a6ec-d09285a0c34b 59228-103 HUMAN OTC DRUG SINOFRESH NASAL AND SINUS CARE EUCALYPTUS GLOBULUS LEAF, POTASSIUM DICHROMATE LIQUID TOPICAL 20140530 UNAPPROVED HOMEOPATHIC EMS Contract Packaging EUCALYPTUS GLOBULUS LEAF; POTASSIUM DICHROMATE 20; 30 [hp_X]/100mL; [hp_X]/100mL N 20181231 59229-001_6b558a45-e46b-44cf-9b54-a1525650b73f 59229-001 HUMAN OTC DRUG BANDAGE benzalkonium chloride SWAB TOPICAL 20130706 OTC MONOGRAPH NOT FINAL part333A YUYAO CHENGZE MEDICAL SUPPLIES FACTORY BENZALKONIUM CHLORIDE .0012 mg/mg E 20171231 59229-002_2c8f6bc4-ef2f-4f1b-9664-ff7f88c5e2d9 59229-002 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20130731 OTC MONOGRAPH NOT FINAL part333A YUYAO CHENGZE MEDICAL SUPPLIES FACTORY ALCOHOL 70 mL/100mL E 20171231 59229-003_459aaef0-3e56-4bfc-b4d8-52988c1a8a82 59229-003 HUMAN OTC DRUG BANDAGE benzalkonium chloride SWAB TOPICAL 20130706 OTC MONOGRAPH NOT FINAL part333A YUYAO CHENGZE MEDICAL SUPPLIES FACTORY BENZALKONIUM CHLORIDE .0012 mg/mg E 20171231 59229-004_a24c3c9c-9103-4057-b488-fb08f728f747 59229-004 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20130805 OTC MONOGRAPH NOT FINAL part333A YUYAO CHENGZE MEDICAL SUPPLIES FACTORY ALCOHOL 70 mL/100mL E 20171231 59229-005_7c841b44-ead6-4503-90f7-e6098ee3c2d9 59229-005 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20130805 OTC MONOGRAPH NOT FINAL part333A YUYAO CHENGZE MEDICAL SUPPLIES FACTORY ALCOHOL 70 mL/100mL E 20171231 59240-001_6909f7f1-aff9-4bd6-83fc-d6acf4c8a0c0 59240-001 HUMAN OTC DRUG Medicated Body Powder menthol and zinc oxide POWDER TOPICAL 20130718 OTC MONOGRAPH FINAL part347 MAGVERZ INC MENTHOL; ZINC OXIDE .15; 1 g/100g; g/100g N 20181231 59240-002_fa8835a8-5f7b-487f-bfc6-6d2740f1e412 59240-002 HUMAN OTC DRUG Cold and Hot Menthol SPRAY TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part348 MAGVERZ INC MENTHOL 16 g/100mL E 20171231 59240-003_23f2cb9b-3189-4389-a0b0-bfeb7c2ce53a 59240-003 HUMAN OTC DRUG Cold and Hot Menthol CREAM TOPICAL 20130718 OTC MONOGRAPH NOT FINAL part348 MAGVERZ INC MENTHOL .075 g/g E 20171231 59240-004_ea7389b9-5955-42eb-9eb8-503c22cb1e55 59240-004 HUMAN OTC DRUG KEPTRILS MENTHOL LOZENGE ORAL 20150903 OTC MONOGRAPH FINAL part341 MAGVERZ INC MENTHOL 5 mg/1 E 20171231 59240-005_dc3794c6-05d9-43d4-a206-4a53b0bbee9c 59240-005 HUMAN OTC DRUG Tiger delayspray LIDOCAINE SPRAY TOPICAL 20170103 OTC MONOGRAPH FINAL part346 Magverz INC LIDOCAINE 10 mg/100mL N 20181231 59240-006_3cd05633-1eab-4ba7-abf1-3d90c819e36b 59240-006 HUMAN OTC DRUG Tiger delayspray LIDOCAINE SPRAY TOPICAL 20170103 OTC MONOGRAPH FINAL part346 Magverz INC LIDOCAINE 10 mg/100mL N 20181231 59243-100_e3cd2717-4e68-4fa1-9ca9-4d0aee15a933 59243-100 HUMAN OTC DRUG Septicare BENZETHONIUM CHLORIDE SOLUTION TOPICAL 19990626 OTC MONOGRAPH NOT FINAL part333A Sage Pharmaceuticals, Inc. BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 59243-110_bfc2c082-1a15-491d-84bd-a8ca08f00c68 59243-110 HUMAN OTC DRUG Perifoam BENZETHONIUM CHLORIDE SOLUTION TOPICAL 20001121 OTC MONOGRAPH NOT FINAL part333A Sage Pharmaceuticals, Inc. BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 59246-0001_f2cd1e05-f678-4d77-9d70-959f321e340f 59246-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130430 UNAPPROVED MEDICAL GAS A-Z HME Inc OXYGEN 99 L/100L E 20171231 59248-001_16bd17e8-5b8b-4e06-b0c8-5218593d3afb 59248-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19810101 UNAPPROVED MEDICAL GAS Visiting Home Care Services Inc. dba VNA Medical Equipment and Supplies OXYGEN 99 L/100L E 20171231 59256-001_45127a3b-d7ca-444b-9d39-a3eb115caeb2 59256-001 HUMAN OTC DRUG Audiologists Choice EARWAX REMOVAL SYSTEM Earwax Removal CARBAMIDE PEROXIDE LIQUID TOPICAL 20141128 OTC MONOGRAPH FINAL part344 Oaktree Products Inc. CARBAMIDE PEROXIDE 65 mg/mL N 20181231 59260-035_24723e60-7340-45e9-96de-a596581b9309 59260-035 HUMAN OTC DRUG Rocky Mountain Sunscreen Octinoxate, octisalate, octocrylene, titanium dioxide CREAM TOPICAL 20100519 OTC MONOGRAPH FINAL part352 Creative Cosmetics Inc. dba CCI OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 5; 10; 1.3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 59260-035_f55942c2-5fe3-4439-8560-6bab2b2a4ffb 59260-035 HUMAN OTC DRUG Rocky Mountain Sunscreen Octinoxate, octisalate, octocrylene, titanium dioxide CREAM TOPICAL 20100519 OTC MONOGRAPH FINAL part352 Creative Cosmetics Inc. dba CCI OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 5; 10; 1.3 L/100L; L/100L; L/100L; L/100L E 20171231 59260-135_257ab7e9-e1f0-40ca-8275-d99de03f7c72 59260-135 HUMAN OTC DRUG Rocky Mountain Sunscreen Octinoxate, octisalate, octocrylene, titanium dioxide CREAM TOPICAL 20100519 OTC MONOGRAPH FINAL part352 Creative Cosmetics Inc. dba CCI OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 5; 10; 1.3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 59260-135_b29bf84e-28b4-4bbd-be59-ca8d19aab9f4 59260-135 HUMAN OTC DRUG Rocky Mountain Sunscreen Octinoxate, octisalate, octocrylene, titanium dioxide CREAM TOPICAL 20100519 OTC MONOGRAPH FINAL part352 Creative Cosmetics Inc. dba CCI OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 5; 10; 1.3 L/100L; L/100L; L/100L; L/100L E 20171231 59262-101_78d98cbc-3096-4297-beff-56727962a860 59262-101 HUMAN OTC DRUG Arnica Active arnica montana, calendula officinalis flowering top, hypericum perforatum and symphytum officinale whole SPRAY TOPICAL 20140327 UNAPPROVED HOMEOPATHIC Similasan Corporation ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; SYMPHYTUM OFFICINALE WHOLE 4; 4; 4; 6 [hp_X]/90mL; [hp_X]/90mL; [hp_X]/90mL; [hp_X]/90mL N 20181231 59262-102_60a615bb-306b-450f-944f-eb5181daa33a 59262-102 HUMAN OTC DRUG Arnica Active Roll-On Arnica Montana LIQUID TOPICAL 20170201 UNAPPROVED HOMEOPATHIC Similasan Corporation ARNICA MONTANA 1 [hp_X]/mL N 20181231 59262-240_ef2983bd-82d8-4abf-a184-e04a7fa314e5 59262-240 HUMAN OTC DRUG Sinus Relief Kali bichromicum, Luffa operculata, Sabadilla SPRAY NASAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation POTASSIUM DICHROMATE; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 59262-241_a28499fd-2769-4f79-9650-eec121488691 59262-241 HUMAN OTC DRUG Nasal Allergy Relief cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit and schoenocaulon officinale seed SPRAY NASAL 20100515 UNAPPROVED HOMEOPATHIC Similasan Corporation CARDIOSPERMUM HALICACABUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 6; 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 59262-242_25c5f7c8-2768-4769-beb8-b4087e1469dd 59262-242 HUMAN OTC DRUG Allergy and Sinus Relief Cardiospermum Halicacabum Flowering Top, Galphimia Glauca Flowering Top, Luffa Operculata Fruit and Schoenocaulon Officinale Seed TABLET, ORALLY DISINTEGRATING ORAL 20170201 UNAPPROVED HOMEOPATHIC Similasan Corporation CARDIOSPERMUM HALICACABUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 4; 4; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59262-243_2b6a0e33-9486-438d-82ee-bf520b2ce911 59262-243 HUMAN OTC DRUG Sinus Relief POTASSIUM DICHROMATE, LUFFA OPERCULATA FRUIT and SCHOENOCAULON OFFICINALE SEED SPRAY NASAL 20170501 UNAPPROVED HOMEOPATHIC Similasan Corporation POTASSIUM DICHROMATE; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 59262-244_2be0e4f6-425f-44c6-b3c2-1028168bc57b 59262-244 HUMAN OTC DRUG Nasal Allergy Relief CARDIOSPERMUM HALICACABUM FLOWERING TOP, GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT and SCHOENOCAULON OFFICINALE SEED SPRAY NASAL 20170501 UNAPPROVED HOMEOPATHIC Similasan Corporation CARDIOSPERMUM HALICACABUM FLOWERING TOP; GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 6; 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 59262-257_5ef3d513-7b74-4dbe-8b47-d4b4a4fd7010 59262-257 HUMAN OTC DRUG Kids Cold and Mucus Relief Expectorant Antimony Pentasulfide and Potassium Iodide and Polygala Senega Root SYRUP ORAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ANTIMONY PENTASULFIDE; POTASSIUM IODIDE; POLYGALA SENEGA ROOT 12; 12; 8 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL N 20181231 59262-259_e62a4ccd-883d-48a0-a399-e870cc8b82a3 59262-259 HUMAN OTC DRUG Kids Cough and Fever Relief Atropa belladonna and Drosera rotundifolia and Prunus laurocerasus leaf and Rumex crispus root and Polygala Senega Root and Verbascum thapsus SYRUP ORAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; DROSERA ROTUNDIFOLIA; PRUNUS LAUROCERASUS LEAF; RUMEX CRISPUS ROOT; POLYGALA SENEGA ROOT; VERBASCUM THAPSUS 6; 3; 4; 4; 6; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL N 20181231 59262-265_8c0832fc-2cf0-4952-b092-b9cfc58fbf5f 59262-265 HUMAN OTC DRUG Kids Cough and Cold Relief Plus Echinacea, Nighttime atropa belladonna, matricaria recutita, copper, drosera rotundifolia flowering top, echinacea pallida, ferrosoferric phosphate, polygala senega root and zinc SYRUP ORAL 20160201 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; MATRICARIA RECUTITA; COPPER; DROSERA ROTUNDIFOLIA FLOWERING TOP; ECHINACEA PALLIDA; FERROSOFERRIC PHOSPHATE; POLYGALA SENEGA ROOT; ZINC 6; 8; 12; 4; 6; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 59262-266_92a9194c-2095-44cb-b8ce-b770baf55525 59262-266 HUMAN OTC DRUG Kids Cold and Mucus Relief Plus Echinacea atropa belladonna, drosera rotundifolia flowering top, echinacea pallida, prunus laurocerasus leaf, rumex crispus root, linum catharticum, verbascum thapsus and zinc SYRUP ORAL 20160201 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; DROSERA ROTUNDIFOLIA FLOWERING TOP; ECHINACEA PALLIDA; PRUNUS LAUROCERASUS LEAF; RUMEX CRISPUS ROOT; LINUM CATHARTICUM; VERBASCUM THAPSUS; ZINC 6; 4; 6; 4; 4; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 59262-267_f4cc192b-0387-4cd5-a29e-fe7beb03044e 59262-267 HUMAN OTC DRUG Kids Sore Throat Relief Guaiac TABLET, ORALLY DISINTEGRATING ORAL 20170201 UNAPPROVED HOMEOPATHIC Similasan Corporation GUAIAC 21 [hp_X]/1 N 20181231 59262-271_594f401a-b19a-45c7-9128-967811579c05 59262-271 HUMAN OTC DRUG Ear Relief Chamomilla and Mercurius Solubilis and Sulphur SOLUTION AURICULAR (OTIC) 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR 10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-272_695616d1-adfe-407e-9e36-713040ce0928 59262-272 HUMAN OTC DRUG Ear Wax Relief causticum, graphite, lachesis muta venom and lycopodium clavatum spore SOLUTION AURICULAR (OTIC) 20030601 UNAPPROVED HOMEOPATHIC Similasan Corporation CAUSTICUM; GRAPHITE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE 12; 15; 12; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-273_3251b877-6ded-40ad-a2e1-97634803ffaf 59262-273 HUMAN OTC DRUG Kids Ear Relief Matricaria recutita, Mercurius Solubilis, Anemone patens and Sulphur SOLUTION AURICULAR (OTIC) 20140215 UNAPPROVED HOMEOPATHIC Similasan Corporation MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; ANEMONE PATENS; SULFUR 10; 15; 12; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-274_5afb65f7-c86e-4663-a7e1-238c7648e7c4 59262-274 HUMAN OTC DRUG Childrens Earache Relief Chamomilla 10X, Mercurius solubilis 15X, Pulsatilla 12X, Sulphur 12X SOLUTION AURICULAR (OTIC) 20070101 UNAPPROVED HOMEOPATHIC Similasan Corporation CHAMOMILE; MERCURIUS SOLUBILIS; PULSATILLA PATENS; SULFUR 10; 15; 12; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-275_b2200a32-1cc6-4f95-8dc4-9262e10ffe27 59262-275 HUMAN OTC DRUG Ear Ringing Remedy Chamomilla and Mercurius Solubilis and Sulphur SOLUTION AURICULAR (OTIC) 20180101 UNAPPROVED HOMEOPATHIC Similasan Corporation ARNICA MONTANA FLOWER; QUININE SULFATE; ERIODICTYON CALIFORNICUM LEAF; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SILICA DIMETHYL SILYLATE; ALLYLTHIOUREA 15; 12; 12; 12; 15; 12; 15; 15 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-303_63e8fc29-515f-4e8a-af82-7c0fdaac2a8b 59262-303 HUMAN OTC DRUG Sleep and Dream Anemone Pulsatilla, Avena Sativa Flowering Top, Calcium Sulfide and Zinc Valerate Dihydrate TABLET ORAL 20170201 UNAPPROVED HOMEOPATHIC Similasan Corporation AVENA SATIVA FLOWERING TOP; CALCIUM SULFIDE; ANEMONE PULSATILLA; ZINC VALERATE DIHYDRATE 12; 12; 15; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59262-345_1d5842a2-36bb-4279-ace9-ff3e19dc022b 59262-345 HUMAN OTC DRUG Dry Eye Relief atropa belladonna, euphrasia stricta and mercuric chloride SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-346_238fd6dc-2b21-4ddd-bc4b-cfdc24ed357c 59262-346 HUMAN OTC DRUG Allergy Eye Relief apis mellifera, euphrasia stricta and schoenocaulon officinale seed SOLUTION/ DROPS OPHTHALMIC 19850101 UNAPPROVED HOMEOPATHIC Similasan Corporation APIS MELLIFERA; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL N 20181231 59262-347_07f41be0-781e-4023-bf72-506404ebec74 59262-347 HUMAN OTC DRUG Computer Eye Relief Conium maculatum and Natrium muriaticum and Ruta graveolens and Senega officinalis SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation CONIUM MACULATUM FLOWERING TOP; SODIUM CHLORIDE; RUTA GRAVEOLENS FLOWERING TOP; POLYGALA SENEGA ROOT 6; 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-348_084ed24b-4a8d-478f-8142-a47f771f1390 59262-348 HUMAN OTC DRUG Irritated Eye Relief Atropa Belladonna, Calcium Sulfide and Euphrasia Stricta SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; CALCIUM SULFIDE 6; 6; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-350_0de84ab0-e625-4cfd-bca1-ab1807e208ef 59262-350 HUMAN OTC DRUG Stye Eye Relief conium maculatum flowering top, graphite and sulfur SOLUTION/ DROPS OPHTHALMIC 20050102 UNAPPROVED HOMEOPATHIC Similasan Corporation CONIUM MACULATUM FLOWERING TOP; GRAPHITE; SULFUR 6; 12; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-351_2bfd38bc-3832-4198-8cf3-e166d4fae95c 59262-351 HUMAN OTC DRUG Dry Eye Relief Belladonna 6X, Euphrasia 6X, Mercurius sublimatus 6X SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL N 20181231 59262-352_3e7ad75f-97e1-40d2-8432-d4b8fdf24e68 59262-352 HUMAN OTC DRUG Dry Eye Relief Atropa Belladonna and Euphrasia Stricta and Mercuric Chloride SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL N 20181231 59262-353_b756a19c-d375-4300-973c-9b63f08fb411 59262-353 HUMAN OTC DRUG Allergy Eye Relief Apis Mellifera and Euphrasia Stricta and Schoenocaulon Officinale Seed SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation APIS MELLIFERA; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL N 20181231 59262-354_e18cae59-1f2e-4f85-a147-86cbff87f37f 59262-354 HUMAN OTC DRUG Allergy Eye Relief Apis and Euphrasia and Sabadilla SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation APIS MELLIFERA; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL N 20181231 59262-355_836a4a8d-ee36-46a7-a926-3fbfc144ce25 59262-355 HUMAN OTC DRUG Computer Eye Relief Conium maculatum, Natrium muriaticum, Ruta graveolens, Senega officinalis SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation CONIUM MACULATUM FLOWERING TOP; SODIUM CHLORIDE; RUTA GRAVEOLENS FLOWERING TOP; POLYGALA SENEGA ROOT 6; 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL N 20181231 59262-356_c967127a-39cc-4987-b8d2-504794aab3a7 59262-356 HUMAN OTC DRUG Irritated Eye Relief Atropa belladonna, Euphrasia stricta and Calcium sulfide SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; CALCIUM SULFIDE 6; 6; 12 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL N 20181231 59262-358_3008640b-4c15-4cfc-b39a-91e841830bf7 59262-358 HUMAN OTC DRUG Complete Eye Relief atropa belladonna, euphrasia stricta and mercuric chloride SOLUTION/ DROPS OPHTHALMIC 20140211 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-359_b5b398eb-c6fc-4cc4-9de7-3b955b0768a6 59262-359 HUMAN OTC DRUG Complete Eye Relief Single Use atropa belladonna, euphrasia stricta and mercuric chloride SOLUTION/ DROPS OPHTHALMIC 20140215 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-360_063c3b8a-b194-4335-95cc-f1882972cdd7 59262-360 HUMAN OTC DRUG Aging Eye Relief jacobaea maritima, sodium chloride and ruta graveolens flowering top SOLUTION/ DROPS OPHTHALMIC 20140401 UNAPPROVED HOMEOPATHIC Similasan Corporation JACOBAEA MARITIMA; SODIUM CHLORIDE; RUTA GRAVEOLENS FLOWERING TOP 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-361_b1ceb751-5874-4e09-82d7-20e1a1a8095b 59262-361 HUMAN OTC DRUG Kids Allergy Eye Relief Apis and Euphrasia and Pulsatilla and Sabadilla SOLUTION/ DROPS OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation APIS MELLIFERA; EUPHRASIA STRICTA; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED 6; 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL N 20181231 59262-362_38335b81-bcd9-4b48-8d4e-fb2fe4aa27fe 59262-362 HUMAN OTC DRUG Kids Irritated Eye Relief Belladonna and Euphrasia and Hepar Sulphuris and Thuja LIQUID OPHTHALMIC 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; CALCIUM SULFIDE; PLATYCLADUS ORIENTALIS LEAF 6; 6; 12; 15 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL N 20181231 59262-363_02dcee90-b41f-4e48-adb7-4fde65d1fcd8 59262-363 HUMAN OTC DRUG Redness and Itchy Eye Relief apis mellifera, euphrasia stricta, pulsatilla vulgaris and schoenocaulon officinale seed SOLUTION/ DROPS OPHTHALMIC 20150101 UNAPPROVED HOMEOPATHIC Similasan Corporation APIS MELLIFERA; EUPHRASIA STRICTA; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED 6; 6; 6; 6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-364_4b35c8f1-517a-4e3c-947b-dbe81294388f 59262-364 HUMAN OTC DRUG Allergy Eye Relief apis mellifera, euphrasia stricta, schoenocaulon officinale seed SOLUTION/ DROPS OPHTHALMIC 20150413 UNAPPROVED HOMEOPATHIC Similasan Corporation APIS MELLIFERA; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL N 20181231 59262-365_35be9334-608d-43e3-ac47-c318beff0ea2 59262-365 HUMAN OTC DRUG Pink Eye Relief Belladonna, Euphrasia officinalis, Hepar sulphuris SOLUTION/ DROPS OPHTHALMIC 20170201 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; EUPHRASIA STRICTA; CALCIUM SULFIDE 6; 6; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59262-400_7d6528f8-8408-4d2b-b8a3-4d73fac8c803 59262-400 HUMAN OTC DRUG Burn Recovery calendula officinalis flowering top, lytta vesicatoria, echinacea, unspecified, urtica urens SPRAY TOPICAL 20141101 UNAPPROVED HOMEOPATHIC Similasan Corporation CALENDULA OFFICINALIS FLOWERING TOP; LYTTA VESICATORIA; ECHINACEA, UNSPECIFIED; URTICA URENS 4; 6; 4; 4 [hp_X]/90mL; [hp_X]/90mL; [hp_X]/90mL; [hp_X]/90mL N 20181231 59262-401_18791ac0-d4e5-427a-bd3e-0393d67ffabd 59262-401 HUMAN OTC DRUG Itch Relief apis mellifera, lachesis muta venom, ledum palustre twig and urtica urens LIQUID TOPICAL 20141101 UNAPPROVED HOMEOPATHIC Similasan Corporation APIS MELLIFERA; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; URTICA URENS 12; 12; 6; 8 [hp_X]/7.5mL; [hp_X]/7.5mL; [hp_X]/7.5mL; [hp_X]/7.5mL N 20181231 59262-500_79fcc2ea-76bb-4b93-a844-ca3c83ef0402 59262-500 HUMAN OTC DRUG Baby Teething Plus Tooth Support oyster shell calcium carbonate, crude, calcium fluoride, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, and podophyllum TABLET, ORALLY DISINTEGRATING ORAL 20150101 UNAPPROVED HOMEOPATHIC Similasan Corporation OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; PODOPHYLLUM 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59262-501_f6367f89-1467-46db-b71c-094aa9127ca6 59262-501 HUMAN OTC DRUG Baby Gas and Colic Plus Stomach Cramps atropa belladonna, matricaria recutita, anamirta cocculus whole, citrullus colocynthis fruit pulp and magnesium phosphate, dibasic trihydrate TABLET, ORALLY DISINTEGRATING ORAL 20150101 UNAPPROVED HOMEOPATHIC Similasan Corporation ATROPA BELLADONNA; MATRICARIA RECUTITA; ANAMIRTA COCCULUS WHOLE; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12; 12; 15; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59262-600_6c6fc30f-6221-42ac-a510-b39ae42ba85a 59262-600 HUMAN OTC DRUG Stress and Tension Relief Asafetida, Crataegus Fruit, Lycopus Virginicus and Passiflora Incarnata Flowering Top GLOBULE ORAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation ASAFETIDA; CRATAEGUS FRUIT; LYCOPUS VIRGINICUS; PASSIFLORA INCARNATA FLOWERING TOP 4; 4; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59262-601_088190e0-6a24-4b6c-a72a-00bd79ae7895 59262-601 HUMAN OTC DRUG Sleeplessness Relief Avena sativa and Hepar sulphuris and Pulsatilla and Zincum valerianicum GLOBULE ORAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation AVENA SATIVA FLOWERING TOP; CALCIUM SULFIDE; ANEMONE PATENS; ZINC VALERATE DIHYDRATE 12; 12; 15; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59262-602_1681865e-e60f-4da2-8c7c-6248e69c4733 59262-602 HUMAN OTC DRUG Anxiety Relief Argentum nitricum and Strophantus gratus GLOBULE ORAL 20130702 UNAPPROVED HOMEOPATHIC Similasan Corporation SILVER NITRATE; STROPHANTHUS GRATUS SEED 15; 12 [hp_X]/1; [hp_X]/1 N 20181231 59262-604_0626cdc4-764c-4f1f-aacd-04f933e0bd81 59262-604 HUMAN OTC DRUG Calm and Serenity Asafoetida, Lycopus Virginicus, Selenicereus Grandiflorus Stem and Passiflora Incarnata Flowering Top TABLET, ORALLY DISINTEGRATING ORAL 20170201 UNAPPROVED HOMEOPATHIC Similasan Corporation ASAFETIDA; SELENICEREUS GRANDIFLORUS STEM; LYCOPUS VIRGINICUS; PASSIFLORA INCARNATA FLOWERING TOP 4; 4; 3; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59262-605_28e3a715-a639-4192-a568-2e6ada538edc 59262-605 HUMAN OTC DRUG Heartburn Relief Oyster Shell Calcium Carbonate, Crude, Sodium Phosphate, Dibasic, Heptahydrate, Strychnos Nux-Vomica Seed TABLET, ORALLY DISINTEGRATING ORAL 20170201 UNAPPROVED HOMEOPATHIC Similasan Corporation OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED 15; 12; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59262-606_ccc64678-0520-4e29-83b4-dc7c79e95716 59262-606 HUMAN OTC DRUG Calm and Collected Piper methysticum root TABLET, ORALLY DISINTEGRATING ORAL 20170201 UNAPPROVED HOMEOPATHIC Similasan Corporation PIPER METHYSTICUM ROOT 57 [hp_X]/1 N 20181231 59262-607_8e3e6f64-21d9-40fb-9a96-82538cf46bb6 59262-607 HUMAN OTC DRUG Kids Upset Tummy Relief Arsenic Trioxide, Ipecac, Mercuric Chloride and Podophyllum TABLET, ORALLY DISINTEGRATING ORAL 20170201 UNAPPROVED HOMEOPATHIC Similasan Corporation ARSENIC TRIOXIDE; IPECAC; MERCURIC CHLORIDE; PODOPHYLLUM 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59275-001_a5efe53a-7e76-44cf-9eb7-236b656303ef 59275-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19911010 NDA NDA205767 United Welding Supply Co., Inc OXYGEN 990 mL/L N 20181231 59276-209_71cf7fd2-76b4-4d0a-8150-6fb274f8db69 59276-209 HUMAN OTC DRUG A-Med brand First Aid Eye and Skin-Rinse Purified Water SOLUTION CUTANEOUS; OPHTHALMIC; TOPICAL 20131101 OTC MONOGRAPH FINAL part349 1602041 Ontario Limited WATER 98.577 mL/100mL N 20181231 59279-502_ee375084-8175-479a-88af-1ac675b4fbe3 59279-502 HUMAN OTC DRUG SOLV X salicylic acid SHAMPOO TOPICAL 19940101 OTC MONOGRAPH FINAL part358H Mediceutical Laboratories, LTD SALICYLIC ACID 18 mg/L E 20171231 59279-505_5481e2f4-08c6-46e2-a36e-d50b07da7b63 59279-505 HUMAN OTC DRUG X FOLATE coal tar SHAMPOO TOPICAL 19930101 OTC MONOGRAPH FINAL part358H Mediceutical Laboratories, LTD COAL TAR 50 mg/mL E 20171231 59279-507_28021efc-b567-404f-e054-00144ff88e88 59279-507 HUMAN OTC DRUG Mediceuticals X-Derma Dry Scalp and Hair Treatment Salicylic Acid SHAMPOO TOPICAL 20121127 OTC MONOGRAPH FINAL part358H Mediceutical Laboratories, Ltd. SALICYLIC ACID 1.8 g/100mL N 20181231 59279-514_bb13fe13-32ce-4d7c-988e-1bfff481eee1 59279-514 HUMAN OTC DRUG THERAPEUTIC pyrithione zinc RINSE TOPICAL 20070101 OTC MONOGRAPH FINAL part358H Mediceutical Laboratories, LTD PYRITHIONE ZINC 5 mg/mL E 20171231 59279-530_c5838590-724c-40c4-8ebf-bf09a6404ca2 59279-530 HUMAN OTC DRUG THERA RX triclosan SOLUTION TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part333E Mediceutical Laboratories, LTD TRICLOSAN 3 mg/mL E 20171231 59294-000_8adabb57-7de3-4895-9b6d-ef72c1923898 59294-000 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL LIQUID TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part333A Global Healthcare ISOPROPYL ALCOHOL 70 g/100g N 20181231 59294-001_c6fdb60b-2156-461a-a8e0-f9ff4be432fa 59294-001 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL LIQUID TOPICAL 20130711 OTC MONOGRAPH NOT FINAL part333A Global Healthcare ISOPROPYL ALCOHOL 70 g/100g N 20181231 59301-001_0d669e84-71d3-4fc2-b297-c7d2e2e86bb2 59301-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Oxygen Support Systems Inc OXYGEN 99 L/100L E 20171231 59303-1001_9e6a9f44-820d-4499-8e56-5fb09e42865b 59303-1001 HUMAN OTC DRUG Hanip Gargle apple fragrance Sodium Fluoride MOUTHWASH DENTAL 20130713 OTC MONOGRAPH FINAL part355 PISHONANC Co, Ltd SODIUM FLUORIDE 20 mg/100000mL E 20171231 59303-2001_1bb50883-46aa-49e2-aee3-a2e87e0a62b9 59303-2001 HUMAN OTC DRUG Hanip Gargle pine fragrance Sodium Fluoride MOUTHWASH DENTAL 20130713 OTC MONOGRAPH FINAL part355 PISHONANC Co, Ltd SODIUM FLUORIDE 20 mg/100000mL E 20171231 59305-028_9d91ffac-cb8b-4b94-8107-57f39732dd7b 59305-028 HUMAN OTC DRUG Senior B Skin Protectant CREAM TOPICAL 20130710 OTC MONOGRAPH FINAL part347 NEAT FEAT PRODUCTS ZINC ACETATE 1.5 g/75g E 20171231 59305-030_0498ea9c-bc86-4a00-80ae-fa2572977335 59305-030 HUMAN OTC DRUG Cool Foot Antiperspirant SPRAY TOPICAL 20130710 OTC MONOGRAPH FINAL part350 NEAT FEAT PRODUCTS ALUMINUM CHLOROHYDRATE 12 g/125g E 20171231 59310-202_514b0c51-609e-46b0-81b5-30fc1e7c3ba5 59310-202 HUMAN PRESCRIPTION DRUG QVAR Beclomethasone Dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20140915 NDA NDA020911 Teva Respiratory, LLC BECLOMETHASONE DIPROPIONATE 40 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59310-204_514b0c51-609e-46b0-81b5-30fc1e7c3ba5 59310-204 HUMAN PRESCRIPTION DRUG QVAR Beclomethasone Dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20140915 NDA NDA020911 Teva Respiratory, LLC BECLOMETHASONE DIPROPIONATE 80 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59310-206_d6be2b23-e7a9-41d1-8c71-ea12812ccb07 59310-206 HUMAN PRESCRIPTION DRUG QNASL Beclomethasone Dipropionate AEROSOL, METERED NASAL 20150201 NDA NDA202813 Teva Respiratory, LLC BECLOMETHASONE DIPROPIONATE 40 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59310-210_8ace5b8c-b5e7-4446-ad86-5443e8236764 59310-210 HUMAN PRESCRIPTION DRUG QNASL Beclomethasone Dipropionate AEROSOL, METERED NASAL 20120413 NDA NDA202813 Teva Respiratory, LLC BECLOMETHASONE DIPROPIONATE 80 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59310-579_93bb6b3d-e3fc-4cad-95da-798c48dde43d 59310-579 HUMAN PRESCRIPTION DRUG PROAIR HFA Albuterol Sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20121203 NDA NDA021457 Teva Respiratory, LLC ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 59310-580_602bb65a-e6cd-4d78-9454-3d9ff5bafc9b 59310-580 HUMAN PRESCRIPTION DRUG ProAir RespiClick Albuterol Sulfate POWDER, METERED RESPIRATORY (INHALATION) 20150423 NDA NDA205636 Teva Respiratory, LLC ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 59310-610_6583781a-c062-400d-8b2d-4ae8668e31b8 59310-610 HUMAN PRESCRIPTION DRUG CINQAIR Reslizumab INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160418 BLA BLA761033 Teva Respiratory, LLC RESLIZUMAB 10 mg/mL Interleukin-5 Antagonist [EPC],Interleukin-5 Antagonists [MoA] N 20181231 59310-705_9318c411-1f98-4d29-84b7-bb4eb71f182e 59310-705 HUMAN PRESCRIPTION DRUG ArmonAir RespiClick Fluticasone Propionate POWDER, METERED RESPIRATORY (INHALATION) 20170807 NDA NDA208798 Teva Respiratory, LLC FLUTICASONE PROPIONATE 55 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59310-711_9318c411-1f98-4d29-84b7-bb4eb71f182e 59310-711 HUMAN PRESCRIPTION DRUG ArmonAir RespiClick Fluticasone Propionate POWDER, METERED RESPIRATORY (INHALATION) 20170807 NDA NDA208798 Teva Respiratory, LLC FLUTICASONE PROPIONATE 113 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59310-722_9318c411-1f98-4d29-84b7-bb4eb71f182e 59310-722 HUMAN PRESCRIPTION DRUG ArmonAir RespiClick Fluticasone Propionate POWDER, METERED RESPIRATORY (INHALATION) 20170807 NDA NDA208798 Teva Respiratory, LLC FLUTICASONE PROPIONATE 232 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59310-805_6949dad9-9608-4a15-b080-4ae4188388d8 59310-805 HUMAN PRESCRIPTION DRUG AirDuo RespiClick Fluticasone Propionate and Salmeterol POWDER, METERED RESPIRATORY (INHALATION) 20170412 NDA NDA208799 Teva Respiratory, LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 55; 14 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 59310-812_6949dad9-9608-4a15-b080-4ae4188388d8 59310-812 HUMAN PRESCRIPTION DRUG AirDuo RespiClick Fluticasone Propionate and Salmeterol POWDER, METERED RESPIRATORY (INHALATION) 20170420 NDA NDA208799 Teva Respiratory, LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 113; 14 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 59310-822_6949dad9-9608-4a15-b080-4ae4188388d8 59310-822 HUMAN PRESCRIPTION DRUG AirDuo RespiClick Fluticasone Propionate and Salmeterol POWDER, METERED RESPIRATORY (INHALATION) 20170412 NDA NDA208799 Teva Respiratory, LLC FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 232; 14 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 59316-101_606234a7-6409-61f2-e053-2991aa0ae3d1 59316-101 HUMAN OTC DRUG Biofreeze Menthol GEL TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC. MENTHOL 35 mg/mL N 20181231 59316-102_3ce2d09b-f366-6a08-e054-00144ff8d46c 59316-102 HUMAN OTC DRUG Biofreeze MENTHOL GEL TOPICAL 20160919 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 40 mg/mL N 20181231 59316-102_606241cb-1623-8760-e053-2991aa0ac37d 59316-102 HUMAN OTC DRUG BIOFREEZE MENTHOL GEL TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 40 mg/mL N 20181231 59316-103_3ce2d09b-f377-6a08-e054-00144ff8d46c 59316-103 HUMAN OTC DRUG Biofreeze Colorless MENTHOL GEL TOPICAL 20160919 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 40 mg/mL N 20181231 59316-103_60625746-dc36-a45d-e053-2991aa0a43cb 59316-103 HUMAN OTC DRUG Biofreeze Colorless MENTHOL GEL TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 40 mg/mL N 20181231 59316-104_3afbf9ba-8da0-7237-e054-00144ff88e88 59316-104 HUMAN OTC DRUG Biofreeze MENTHOL SPRAY TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 100 mg/mL N 20181231 59316-104_634649d5-bb29-4140-ae5e-219083368149 59316-104 HUMAN OTC DRUG Biofreeze MENTHOL SPRAY TOPICAL 20110519 20181231 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 100 mg/mL N 20181231 59316-104_a105f348-a93a-482a-8688-4ac3951509b2 59316-104 HUMAN OTC DRUG Biofreeze MENTHOL SPRAY TOPICAL 20130115 20181231 OTC MONOGRAPH NOT FINAL part348 Performance Health, Inc. MENTHOL 100 mg/mL N 20181231 59316-106_2bd54a4d-de1e-336d-e054-00144ff8d46c 59316-106 HUMAN OTC DRUG Perform Menthol GEL TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 31 mg/mL N 20181231 59316-107_1348467a-e244-45ad-8047-1b4c29eaab4b 59316-107 HUMAN OTC DRUG Perform MENTHOL SOLUTION TOPICAL 20101117 20181231 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 104 mg/mL N 20181231 59316-107_42bd5a69-b857-473b-a3f7-3d1771e73588 59316-107 HUMAN OTC DRUG Perform MENTHOL SPRAY TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 100 mg/mL N 20181231 59316-107_8f335e01-1214-45c1-9c88-3baff5868cb0 59316-107 HUMAN OTC DRUG Perform MENTHOL SPRAY TOPICAL 20110512 20181231 OTC MONOGRAPH NOT FINAL part348 Performance Health Inc. MENTHOL 104 mg/mL N 20181231 59316-108_2bd580d6-39b1-4892-e054-00144ff88e88 59316-108 HUMAN OTC DRUG Perform MENTHOL GEL TOPICAL 20091230 20191231 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 31 mg/mL N 20181231 59316-109_60627de8-e6a4-9713-e053-2a91aa0a9ac2 59316-109 HUMAN OTC DRUG PERFORM MENTHOL SPRAY TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 104 mg/mL N 20181231 59316-110_64d847e4-d026-4a90-a305-e15afea10dfb 59316-110 HUMAN OTC DRUG Perform Cool and Soothing Pain Relieving Foot MENTHOL SPRAY TOPICAL 20150914 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC MENTHOL 104 mg/mL N 20181231 59316-111_47f44c88-ca8b-42e1-e054-00144ff8d46c 59316-111 HUMAN OTC DRUG PERFORM COOL and SOOTHING PAIN RELIEVING MENTHOL GEL TOPICAL 20150518 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC MENTHOL 35 mg/mL N 20181231 59316-112_47f47562-066e-3f61-e054-00144ff88e88 59316-112 HUMAN OTC DRUG PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ON MENTHOL GEL TOPICAL 20150518 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC MENTHOL 35 mg/mL N 20181231 59316-114_2cebc1f6-6361-3ad2-e054-00144ff88e88 59316-114 HUMAN OTC DRUG Biofreeze MENTHOL SPRAY TOPICAL 20140219 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 105 mg/mL N 20181231 59316-114_60934241-62c9-0ef7-e053-2991aa0a45dd 59316-114 HUMAN OTC DRUG Biofreeze MENTHOL SPRAY TOPICAL 20160919 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 105 mg/mL N 20181231 59316-115_34a1502e-4ebb-2efc-e054-00144ff8d46c 59316-115 HUMAN OTC DRUG Biofreeze Professional MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC MENTHOL, UNSPECIFIED FORM 50 mg/mL E 20171231 59316-116_34a1502e-4eab-2efc-e054-00144ff8d46c 59316-116 HUMAN OTC DRUG Biofreeze Professional Colorless MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC MENTHOL, UNSPECIFIED FORM 50 mg/mL E 20171231 59316-117_34a130b3-5afc-7380-e054-00144ff88e88 59316-117 HUMAN OTC DRUG Biofreeze Professional Roll-On MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC MENTHOL, UNSPECIFIED FORM 50 mg/mL E 20171231 59316-118_34a1502e-4ecb-2efc-e054-00144ff8d46c 59316-118 HUMAN OTC DRUG Biofreeze Professional Colorless Roll-On MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC MENTHOL, UNSPECIFIED FORM 50 mg/mL E 20171231 59316-119_34a130b3-5b0c-7380-e054-00144ff88e88 59316-119 HUMAN OTC DRUG Biofreeze Professional MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC MENTHOL, UNSPECIFIED FORM 50 mg/mL E 20171231 59316-120_34a1502e-4edb-2efc-e054-00144ff8d46c 59316-120 HUMAN OTC DRUG Biofreeze Professional MENTHOL, UNSPECIFIED FORM SPRAY TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC MENTHOL, UNSPECIFIED FORM 105 mg/mL E 20171231 59316-205_5c3a89ef-a0b7-bb12-e053-2a91aa0aeb0b 59316-205 HUMAN OTC DRUG Biofreeze Roll-On MENTHOL GEL TOPICAL 20130117 OTC MONOGRAPH NOT FINAL part348 Performance Health Inc. MENTHOL 40 mg/mL N 20181231 59316-206_2c22ebec-9f44-0e8a-e054-00144ff8d46c 59316-206 HUMAN OTC DRUG Biofreeze Colorless Roll-On MENTHOL GEL TOPICAL 20130117 OTC MONOGRAPH NOT FINAL part348 Performance Health Inc. MENTHOL 40 mg/mL N 20181231 59316-300_1921a73a-4209-4f16-98b1-9fa25d7e1f6f 59316-300 HUMAN OTC DRUG Perform Atomic Heat Capsaicin, Methyl Salicylate CREAM TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC CAPSAICIN; METHYL SALICYLATE .34; 100 mg/mL; mg/mL E 20171231 59316-301_f1b22772-bfad-42dc-acad-042081d082ef 59316-301 HUMAN OTC DRUG dynaFreeze MENTHOL LIQUID TOPICAL 20100825 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC MENTHOL 35 mg/mL N 20181231 59316-302_f7fd5c2d-a116-479e-bb7e-ae048f0e5233 59316-302 HUMAN OTC DRUG PERFORM ATOMIC HEAT CAPSAICIN, METHYL SALICYLATE CREAM TOPICAL 20150506 OTC MONOGRAPH NOT FINAL part348 Performance Health LLC CAPSAICIN; METHYL SALICYLATE .34; 100 mg/mL; mg/mL E 20171231 59316-303_38b5641d-9703-6e67-e054-00144ff88e88 59316-303 HUMAN OTC DRUG Perform Atomic Heat CAPSAICIN, METHYL SALICYLATE CREAM TOPICAL 20160728 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC CAPSAICIN; METHYL SALICYLATE .3; 100 mg/mL; mg/mL E 20171231 59316-304_38b47adc-4a37-621c-e054-00144ff8d46c 59316-304 HUMAN OTC DRUG Perform Atomic Heat CAPSAICIN, METHYL SALICYLATE CREAM TOPICAL 20160728 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC CAPSAICIN; METHYL SALICYLATE .3; 100 mg/mL; mg/mL E 20171231 59316-994_4fe5e10f-f3a9-0201-e054-00144ff88e88 59316-994 HUMAN OTC DRUG Iso-Quin ALCOHOL GEL TOPICAL 20170518 OTC MONOGRAPH NOT FINAL part333E Performance Health LLC ALCOHOL 680 mg/mL N 20181231 59316-995_4fe5e10f-f3b8-0201-e054-00144ff88e88 59316-995 HUMAN OTC DRUG Skin-Lube ALCOHOL OINTMENT TOPICAL 20170518 OTC MONOGRAPH FINAL part347 Performance Health LLC PETROLATUM; DIMETHICONE 850; 15 mg/g; mg/g N 20181231 59316-996_4fe60940-eb4a-3d44-e054-00144ff8d46c 59316-996 HUMAN OTC DRUG Red Hot CAPSAICIN OINTMENT TOPICAL 20170519 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC CAPSAICIN .05 g/100g N 20181231 59316-997_609375fa-c26b-12c0-e053-2a91aa0a9d38 59316-997 HUMAN OTC DRUG Iso-Quin ALCOHOL LIQUID TOPICAL 20170519 OTC MONOGRAPH NOT FINAL part333E Performance Health, LLC ALCOHOL 650 mg/mL N 20181231 59316-998_575e1d73-5bab-69b6-e053-2991aa0a469f 59316-998 HUMAN OTC DRUG Cramergesic MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20170519 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC MENTHOL; METHYL SALICYLATE 1.9; 13.7 g/100g; g/100g N 20181231 59316-999_575e1d73-5bb8-69b6-e053-2991aa0a469f 59316-999 HUMAN OTC DRUG Atomic Balm METHYL SALICYLATE, CAPSAICIN OINTMENT TOPICAL 20170519 OTC MONOGRAPH NOT FINAL part348 Performance Health, LLC METHYL SALICYLATE; CAPSAICIN 12.5; .025 g/100g; g/100g N 20181231 59321-031_a96d3761-c870-4ae7-98d6-3dc9cd54ee04 59321-031 HUMAN OTC DRUG SHU JIN LU CAMPHOR AND MENTHOL SPRAY TOPICAL 20110407 OTC MONOGRAPH NOT FINAL part348 GUANGXI YULIN PHARMACEUTICAL CO LTD CAMPHOR (SYNTHETIC); MENTHOL 5.5; 5.5 g/100mL; g/100mL N 20181231 59321-032_cee6bf4e-c6e7-40c2-abfe-a3df37fd67c7 59321-032 HUMAN OTC DRUG JIN GU WANG CAMPHOR AND MENTHOL SPRAY TOPICAL 20110407 OTC MONOGRAPH NOT FINAL part348 GUANGXI YULIN PHARMACEUTICAL CO LTD CAMPHOR (SYNTHETIC); MENTHOL 5.5; 5.5 g/100mL; g/100mL N 20181231 59321-033_15b44819-929a-4388-b350-eb5b49160a57 59321-033 HUMAN OTC DRUG YUN XIANG JING MENTHOL LINIMENT PERCUTANEOUS; TRANSDERMAL 20021008 OTC MONOGRAPH NOT FINAL part348 GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD MENTHOL 3 g/100mL N 20181231 59321-055_6ada155e-94c3-4f5e-a1bc-217fd94915d4 59321-055 HUMAN OTC DRUG ZHENG GU SHUI CAMPHOR, MENTHOL LINIMENT PERCUTANEOUS; TRANSDERMAL 20001019 OTC MONOGRAPH NOT FINAL part348 GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD CAMPHOR (SYNTHETIC); MENTHOL 5.6; 5.6 g/100mL; g/100mL N 20181231 59332-001_a25da9ed-2464-435f-be97-c87e26548f79 59332-001 HUMAN OTC DRUG Sprayable Energy caffeinum SPRAY TOPICAL 20130820 UNAPPROVED HOMEOPATHIC Spayable Energy LLC CAFFEINE 1 [hp_X]/8mL N 20181231 59336-001_0338da5d-96b1-4707-b76b-524fa1c1731a 59336-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20131212 NDA NDA205767 JW Welding Supplies & Tools OXYGEN 99 L/100L E 20171231 59338-775_96ac956c-cb06-4f94-8852-46eb527d7e68 59338-775 HUMAN PRESCRIPTION DRUG Feraheme ferumoxytol INJECTION INTRAVENOUS 20090713 NDA NDA022180 AMAG Pharmaceuticals, Inc. FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE 510 mg/17mL Parenteral Iron Replacement [EPC],Iron [Chemical/Ingredient] N 20191231 59342-5003_59b70a14-fb44-732f-e053-2a91aa0a2069 59342-5003 HUMAN OTC DRUG Olbas Pastilles Menthol PASTILLE ORAL 20100324 OTC MONOGRAPH FINAL part341 G. R. Lane Health Products Limited MENTHOL 10 mg/1 N 20181231 59351-0301_838a06af-d580-4197-9773-8e2932b35111 59351-0301 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Pink Benefit (105) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0302_b3f874e6-1dcd-4182-a8fb-adcf143152eb 59351-0302 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Pink Remedy (110) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0303_d83c1bec-b14e-46a3-a1ad-0bed70ebe183 59351-0303 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Rose Cocoon (115) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0304_cd4c3876-9342-43bc-8aaf-140915b3f3d3 59351-0304 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Hydra Beige (120) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0305_002ae683-265f-4baf-a1d2-daf8b2741a0a 59351-0305 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Mauve Renew (125) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0306_bb14a74d-47c2-4f7d-bdb5-beb04ae80574 59351-0306 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Active Mauve (135) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0307_f243cc0e-70c6-4c7d-98b4-1a74d502757f 59351-0307 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Pink Protect (145) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0308_cb07f5a0-9ef3-4d66-838e-c933f1035c9e 59351-0308 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Berry Bliss (245) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0309_9d6480af-0d10-40b9-b599-b0007df50adf 59351-0309 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Purple Rescue (335) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0310_c80f9eee-4083-4aef-8553-5e25848ec7ce 59351-0310 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Fuscia Theraphy (345) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0311_d607ae15-9903-45b4-8f8d-69c378a40446 59351-0311 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Pink Spa (365) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0312_8cd0164f-71fb-4f4a-9a5a-60ba895a0d99 59351-0312 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - SOS Red (525) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0313_f24fe37a-37e0-4bb2-859e-b0d31f980553 59351-0313 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Red Action (565) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0314_22393892-de11-455d-845b-ba153693d40c 59351-0314 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Cherry Boost (585) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0315_8358ce7f-9bf2-4815-96be-67e9df7e9277 59351-0315 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Ivory (120) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0316_5aa1e521-e75f-436d-b1ad-9790ca611d8b 59351-0316 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - True Ivory (130) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0317_fe96166f-5cd4-468c-b1c8-102cea027ee0 59351-0317 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Soft Ivory (220) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0318_8790d569-f225-481e-92d0-f09a24946f16 59351-0318 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Warm Ivory (230) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0319_ba3d0b64-be20-409c-a794-f3091e855a87 59351-0319 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Soft Beige (240) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0320_cf649e76-8230-4b17-a49e-aaceeefefb31 59351-0320 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Classic Beige (250) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0321_56f21937-42b3-475c-8b6d-1fe6f08b6172 59351-0321 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Natural Ivory (260) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0322_66a275fc-e3c3-44d8-b287-c72edb2f7de2 59351-0322 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - True Nude (320) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0323_1c03af16-3396-4b59-ae90-72c22011728e 59351-0323 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Sand (330) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0324_db985500-6b1b-4f83-b538-7f7d94b5a2d1 59351-0324 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Nude (340) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0326_fa1b1d27-b333-4066-b7db-10b0341cd251 59351-0326 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Warm Sand (420) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0327_f5308970-8390-452c-9469-c05a3007d1a6 59351-0327 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Soft Honey (430) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0328_73ad7bac-ffca-42b8-b596-ce20b3dd970b 59351-0328 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Natural Beige (440) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0329_b06292c4-3535-41fa-9f77-827e95e27124 59351-0329 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Natural Caramel (520) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0330_40abd583-8eca-4bcc-97ec-686bee7fe559 59351-0330 HUMAN OTC DRUG Rimmel London Match Perfection Foundation - Warm Caramel (530) OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101006 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; TITANIUM DIOXIDE 1.2; .9 mL/30mL; mL/30mL E 20171231 59351-0331_c585fe29-f477-437f-a440-b3e85fb76d98 59351-0331 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Comfortably Nude (116) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0332_62c3d318-0617-4fdb-8a24-ae1bb90b7d08 59351-0332 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Peach Fusion (117) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59351-0333_2658a9fb-e6a2-4cf5-9968-d63133ddb5aa 59351-0333 HUMAN OTC DRUG Rimmel London Moisture Renew Lipgloss - Coral Reflection (119) Octinoxate, Octisalate CREAM TOPICAL 20101020 OTC MONOGRAPH FINAL part352 Lancaster S.A.M. OCTINOXATE; OCTISALATE .012; .12 mL/6mL; mL/6mL E 20171231 59353-400_7d8d8cf0-0de5-46d4-986f-31af574f3571 59353-400 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20160428 BLA BLA125164 Vifor (International) Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 30 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59353-401_7d8d8cf0-0de5-46d4-986f-31af574f3571 59353-401 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 BLA BLA125164 Vifor (International) Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 50 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59353-402_7d8d8cf0-0de5-46d4-986f-31af574f3571 59353-402 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 BLA BLA125164 Vifor (International) Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 75 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59353-403_7d8d8cf0-0de5-46d4-986f-31af574f3571 59353-403 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 BLA BLA125164 Vifor (International) Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 100 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59353-404_7d8d8cf0-0de5-46d4-986f-31af574f3571 59353-404 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 BLA BLA125164 Vifor (International) Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 150 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59353-405_7d8d8cf0-0de5-46d4-986f-31af574f3571 59353-405 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 BLA BLA125164 Vifor (International) Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 200 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59353-406_7d8d8cf0-0de5-46d4-986f-31af574f3571 59353-406 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20141024 BLA BLA125164 Vifor (International) Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 250 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59353-407_7d8d8cf0-0de5-46d4-986f-31af574f3571 59353-407 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20160428 BLA BLA125164 Vifor (International) Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 120 ug/.3mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59353-408_7d8d8cf0-0de5-46d4-986f-31af574f3571 59353-408 HUMAN PRESCRIPTION DRUG Mircera Methoxy polyethylene glycol-epoetin beta INJECTION, SOLUTION INTRAVENOUS 20160428 BLA BLA125164 Vifor (International) Inc. METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 360 ug/.6mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59365-5006_c5e9e85f-6304-469b-8eab-310feb619b70 59365-5006 HUMAN PRESCRIPTION DRUG Ferric Subsulfate Ferric Subsulfate SOLUTION TOPICAL 19921001 UNAPPROVED DRUG OTHER CooperSurgical, Inc. FERRIC SUBSULFATE 259 mg/g Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 59365-5030_a0e73a6d-4042-442b-903a-dc27c7b054cf 59365-5030 HUMAN PRESCRIPTION DRUG TRIMO SAN Oxyquinoline Sulfate and Sodium Lauryl Sulfate JELLY VAGINAL 19770401 UNAPPROVED DRUG OTHER CooperSurgical, Inc. OXYQUINOLINE SULFATE; SODIUM LAURYL SULFATE .25; .1 mg/g; mg/g N 20181231 59365-5128_80759d3a-13e1-49ea-b4dd-2fdc8b10d5f8 59365-5128 HUMAN PRESCRIPTION DRUG ParaGard T 380A Copper INTRAUTERINE DEVICE INTRAUTERINE 20171102 NDA NDA018680 CooperSurgical, Inc. COPPER 313.4 mg/1 Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] N 20181231 59365-6061_01b6b213-a18c-4379-b6d7-58304c0cd1a7 59365-6061 HUMAN PRESCRIPTION DRUG Leep RediKit mepivacaine hydrochloride, lidocaine hydrochloride, epinephrine bitartrate, iodine, potassium iodide, ferric subsulfate KIT 20150531 UNAPPROVED DRUG OTHER CooperSurgical, Inc. N 20181231 59365-6064_9be0ac8a-509c-4fd3-8f6f-3bd888e4377e 59365-6064 HUMAN PRESCRIPTION DRUG Lugols Strong Iodine Iodine and Potassium Iodide SOLUTION TOPICAL 19921001 UNAPPROVED DRUG OTHER CooperSurgical, Inc. IODINE; POTASSIUM IODIDE .05; .1 g/mL; g/mL N 20181231 59365-6065_85fe69c4-1a8c-490b-873c-5c0ee06ecfb3 59365-6065 HUMAN PRESCRIPTION DRUG Ferric Subsulfate Ferric Subsulfate SOLUTION TOPICAL 19921001 UNAPPROVED DRUG OTHER CooperSurgical, Inc. FERRIC SUBSULFATE 259 mg/g Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 59365-9074_bfd9be4a-5f34-4e0e-81cb-e3ce30b066ee 59365-9074 HUMAN PRESCRIPTION DRUG QKit Procedure Tray lidocaine hydrochloride, epinephrine bitartrate, ferric subsulfate aqueous, iodine and potassium iodide KIT 20150531 UNAPPROVED DRUG OTHER CooperSurgical, Inc. N 20181231 59371-6500_b3f15c3f-63d0-44fd-b80f-edbef8a56230 59371-6500 HUMAN OTC DRUG Hydrating Instant Hand Sanitizer Alcohol GEL TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part333E Micrylium Laboratories ALCOHOL 315 mL/450mL E 20171231 59371-6510_c0c6a22d-57e5-4689-af24-17a952cc399f 59371-6510 HUMAN OTC DRUG Hydrating Instant Hand Sanitizer Alcohol GEL TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part333E Micrylium Laboratories ALCOHOL 42 mL/60mL E 20171231 59378-001_ab1e906a-64d2-4923-995a-8d3bb21e0285 59378-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130701 NDA NDA205767 Jayco Industrial Supply Inc OXYGEN 995 mL/L N 20181231 59385-012_fa5088dd-fa5f-4a5e-a81f-49c360078a2b 59385-012 HUMAN PRESCRIPTION DRUG BUNAVAIL buprenorphine and naloxone FILM BUCCAL 20140930 NDA NDA205637 BioDelivery Sciences International, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2.1; .3 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 59385-014_fa5088dd-fa5f-4a5e-a81f-49c360078a2b 59385-014 HUMAN PRESCRIPTION DRUG BUNAVAIL buprenorphine and naloxone FILM BUCCAL 20140930 NDA NDA205637 BioDelivery Sciences International, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 4.2; .7 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 59385-016_fa5088dd-fa5f-4a5e-a81f-49c360078a2b 59385-016 HUMAN PRESCRIPTION DRUG BUNAVAIL buprenorphine and naloxone FILM BUCCAL 20140930 NDA NDA205637 BioDelivery Sciences International, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 6.3; 1 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 59385-021_5e70d583-4240-32b3-e053-2991aa0a9d6b 59385-021 HUMAN PRESCRIPTION DRUG BELBUCA buprenorphine hydrochloride FILM, SOLUBLE BUCCAL 20170901 NDA NDA207932 BioDelivery Sciences International Inc BUPRENORPHINE HYDROCHLORIDE 75 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 59385-022_5e70d583-4240-32b3-e053-2991aa0a9d6b 59385-022 HUMAN PRESCRIPTION DRUG BELBUCA buprenorphine hydrochloride FILM, SOLUBLE BUCCAL 20171001 NDA NDA207932 BioDelivery Sciences International Inc BUPRENORPHINE HYDROCHLORIDE 150 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] N 20181231 59385-023_5e70d583-4240-32b3-e053-2991aa0a9d6b 59385-023 HUMAN PRESCRIPTION DRUG BELBUCA buprenorphine hydrochloride FILM, SOLUBLE BUCCAL 20170901 NDA NDA207932 BioDelivery Sciences International Inc BUPRENORPHINE HYDROCHLORIDE 300 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] N 20181231 59385-024_5e70d583-4240-32b3-e053-2991aa0a9d6b 59385-024 HUMAN PRESCRIPTION DRUG BELBUCA buprenorphine hydrochloride FILM, SOLUBLE BUCCAL 20170821 NDA NDA207932 BioDelivery Sciences International Inc BUPRENORPHINE HYDROCHLORIDE 450 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] N 20181231 59385-025_5e70d583-4240-32b3-e053-2991aa0a9d6b 59385-025 HUMAN PRESCRIPTION DRUG BELBUCA buprenorphine hydrochloride FILM, SOLUBLE BUCCAL 20170824 NDA NDA207932 BioDelivery Sciences International Inc BUPRENORPHINE HYDROCHLORIDE 600 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] N 20181231 59385-026_5e70d583-4240-32b3-e053-2991aa0a9d6b 59385-026 HUMAN PRESCRIPTION DRUG BELBUCA buprenorphine hydrochloride FILM, SOLUBLE BUCCAL 20171001 NDA NDA207932 BioDelivery Sciences International Inc BUPRENORPHINE HYDROCHLORIDE 750 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] N 20181231 59385-027_5e70d583-4240-32b3-e053-2991aa0a9d6b 59385-027 HUMAN PRESCRIPTION DRUG BELBUCA buprenorphine hydrochloride FILM, SOLUBLE BUCCAL 20170811 NDA NDA207932 BioDelivery Sciences International Inc BUPRENORPHINE HYDROCHLORIDE 900 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] N 20181231 59387-001_51b3893f-e65c-481f-a369-28853148238a 59387-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19800101 NDA NDA205767 A-Welders and Medical Supply, Inc OXYGEN 99 L/100L N 20181231 59387-002_63a13dbf-f130-47a6-abe2-adfaa2dde92b 59387-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19800101 NDA NDA205766 A-Welders and Medical Supply, Inc NITROGEN 99 L/100L N 20181231 59390-036_9c9dbeb1-1b8e-4e93-b1a1-d65667a11964 59390-036 HUMAN OTC DRUG 12 Hour Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20010601 OTC MONOGRAPH FINAL part341 Altaire Pharmaceuticals Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 59390-140_6467bdfc-698a-416e-97ed-f05c31b69063 59390-140 HUMAN PRESCRIPTION DRUG Ofloxacin ophthalmic Ofloxacin SOLUTION OPHTHALMIC 20130531 ANDA ANDA202692 Altaire Pharmaceuticals Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 59390-149_3244f98e-1b51-49ea-9d74-6cb4023675a6 59390-149 HUMAN PRESCRIPTION DRUG Diclofenac Diclofenac Sodium SOLUTION/ DROPS OPHTHALMIC 20151116 ANDA ANDA203383 Altaire Pharmaceuticals Inc. DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 59390-177_8de55300-9137-4213-bd54-74d93dee9299 59390-177 HUMAN OTC DRUG Naphazoline HCI And Pheniramine Maleate NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE SOLUTION/ DROPS OPHTHALMIC 20101006 ANDA ANDA078208 Altaire Pharmaceuticals Inc. NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .027; .315 mL/100mL; mL/100mL N 20181231 59390-181_b7418be5-fd9c-4f79-a764-51bf037e0f17 59390-181 HUMAN PRESCRIPTION DRUG ALTACAINE Tetracaine Hydrochloride SOLUTION OPHTHALMIC 20020201 UNAPPROVED DRUG OTHER Altaire Pharmaceuticals Inc. TETRACAINE HYDROCHLORIDE 5 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 59390-192_3438498e-827a-4eb2-abbb-d7a0a4e89b4e 59390-192 HUMAN PRESCRIPTION DRUG HOMATROPINE HYDROBROMIDE OPHTHALMIC Homatropine Hydrobromide SOLUTION OPHTHALMIC 20130516 UNAPPROVED DRUG OTHER Altaire Pharmaceuticals Inc. HOMATROPINE HYDROBROMIDE 50 mg/mL Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20191231 59390-205_9de57290-3d78-4929-a4e2-fd72fe1eb8c2 59390-205 HUMAN PRESCRIPTION DRUG Fluorescein Sodium and Proparacaine Hydrochloride Fluorescein Sodium and Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20000614 UNAPPROVED DRUG OTHER Altaire Pharmaceuticals Inc. FLUORESCEIN SODIUM; PROPARACAINE HYDROCHLORIDE 2.5; 5 mg/mL; mg/mL Diagnostic Dye [EPC],Dyes [MoA],Local Anesthesia [PE],Local Anesthetic [EPC] N 20181231 59390-206_3f415ffe-f95c-418b-9ee3-a1e34670a4e5 59390-206 HUMAN PRESCRIPTION DRUG ALTAFLUOR Fluorescein Sodium and Benoxinate Hydrochloride SOLUTION OPHTHALMIC 20000621 UNAPPROVED DRUG OTHER Altaire Pharmaceuticals Inc. BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM 4; 2.5 mg/mL; mg/mL Diagnostic Dye [EPC],Dyes [MoA] N 20181231 59392-6051_b8ec3a15-2e7a-4181-9eab-3e78198d6269 59392-6051 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140501 ANDA ANDA207175 PharmTak, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 59392-6052_b8ec3a15-2e7a-4181-9eab-3e78198d6269 59392-6052 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140501 ANDA ANDA207175 PharmTak, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 59397-3310_60e2bc2f-5696-8fea-e053-2a91aa0a066f 59397-3310 HUMAN OTC DRUG OFF Bite and Itch Relief First Aid Antiseptic Benzocaine, Phenol, Camphor SOLUTION TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part348 S. C. Johnson & Son, Inc. BENZOCAINE; PHENOL; CAMPHOR (NATURAL) 5; 1.35; 3 mg/100mL; mg/100mL; mg/100mL N 20181231 59400-001_980e35ca-c11f-4210-90f7-8c219f736aec 59400-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20131029 UNAPPROVED MEDICAL GAS BayCare Home Care, Inc. OXYGEN 210 mL/L N 20181231 59400-005_980e35ca-c11f-4210-90f7-8c219f736aec 59400-005 HUMAN PRESCRIPTION DRUG Oxygen Oxygen LIQUID RESPIRATORY (INHALATION) 20131105 UNAPPROVED MEDICAL GAS BayCare Home Care, Inc. OXYGEN 210 mg/kg N 20181231 59401-001_05b6d133-e046-4a84-827e-0d4a85f746ff 59401-001 HUMAN OTC DRUG Manefit Beauty Planner Lavender Wrinkle Lifting Mask Adenosine CREAM TOPICAL 20151015 UNAPPROVED DRUG OTHER Imine Co., Ltd ADENOSINE .08 mg/20mL N 20181231 59401-002_31ef21c0-9a68-42f8-9644-80cc84c3811b 59401-002 HUMAN OTC DRUG Manefit Beauty Planner Lily Whitening Brightening Mask Niacinamide CREAM TOPICAL 20151015 UNAPPROVED DRUG OTHER Imine Co., Ltd. NIACINAMIDE 4.6 mg/23mL N 20181231 59401-003_849456a1-bd9b-4b49-9d9d-9e10c87e1914 59401-003 HUMAN OTC DRUG Manefit Beauty Planner Lily Whitening Eye Patch Niacinamide CREAM TOPICAL 20140718 UNAPPROVED DRUG OTHER Imine Co., Ltd. NIACINAMIDE .06 g/3g N 20181231 59401-004_65815eec-21bf-45c2-bcb9-0548c89712fd 59401-004 HUMAN OTC DRUG Manefit Bling Bling Whitening Platinum Hydrogel Mask Niacinamide CREAM TOPICAL 20150907 UNAPPROVED DRUG OTHER Imine Co., Ltd. NIACINAMIDE .6 g/30g N 20181231 59401-005_6da4c744-26c0-4ce1-9617-f40df74232ca 59401-005 HUMAN OTC DRUG Manefit Bling Bling Wrinkle Gold Hydro Gel Mask Adenosine CREAM TOPICAL 20150907 UNAPPROVED DRUG OTHER Imine Co., Ltd. NIACINAMIDE .012 g/30g N 20181231 59401-006_823b9d0a-34f1-4eff-8e3e-875fe4aeeca4 59401-006 HUMAN OTC DRUG Sallys Box Loverecipe Peach Mask Allantoin CREAM TOPICAL 20141118 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .004 mg/20mL N 20181231 59401-007_7b722604-0283-454c-928f-47dddf961053 59401-007 HUMAN OTC DRUG Sallys Box Loverecipe Pomegranate Mask Allantoin CREAM TOPICAL 20141118 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .004 mg/20mL N 20181231 59401-008_951e28ce-0da0-4262-ab0c-600ba9e8fa05 59401-008 HUMAN OTC DRUG Sallys Box Loverecipe Carrot Mask Allantoin CREAM TOPICAL 20141118 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .004 mg/20mL N 20181231 59401-009_d3ab743d-370b-4e5f-9a1c-7bbc973e5b9a 59401-009 HUMAN OTC DRUG Sallys Box Loverecipe Paprika Mask Allantoin CREAM TOPICAL 20141118 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .004 mg/20mL N 20181231 59401-010_112d3ae7-2e1e-48f0-8da3-1725ade0d1bd 59401-010 HUMAN OTC DRUG Sallys Box Secret Garden Lemon Oil Ampoule Mask Niacinamide, Allantoin CREAM TOPICAL 20141119 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN; NIACINAMIDE .0042; .105 mg/21mL; mg/21mL N 20181231 59401-011_a883566d-f7ca-4364-afab-38f1f4500b71 59401-011 HUMAN OTC DRUG Sallys Box Secret Garden Olive Oil Ampoule Mask Dimethicone CREAM TOPICAL 20141119 OTC MONOGRAPH FINAL part347 Imine Co., Ltd DIMETHICONE .4988 mg/21mL N 20181231 59401-012_3d10402c-9409-4796-a26d-05c0e737a39d 59401-012 HUMAN OTC DRUG Sallys Box Secret Garden Camellia Oil Ampoule Mask Dimethicone CREAM TOPICAL 20141125 OTC MONOGRAPH FINAL part347 Imine Co., Ltd DIMETHICONE .42 mg/21mL N 20181231 59401-013_81619d1a-876a-45de-a54c-6a9e045c23ae 59401-013 HUMAN OTC DRUG Sallys Box Secret Garden Tea Tree Oil Ampoule Mask Allantoin CREAM TOPICAL 20141125 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .0042 mg/21mL N 20181231 59401-014_4c1b49f4-5734-4f2d-b5f6-a6adb522d6c1 59401-014 HUMAN OTC DRUG Sallys Box Secret Garden Sunflower Oil Ampoule Mask Dimethicone CREAM TOPICAL 20141125 OTC MONOGRAPH FINAL part347 Imine Co., Ltd DIMETHICONE .42 mg/21mL N 20181231 59401-015_59c4df38-e23a-4271-8420-dffd225dd4c5 59401-015 HUMAN OTC DRUG Sallys Box Delight Collagen Hydrogel Mask Allantoin CREAM TOPICAL 20141202 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .0125 mg/25g N 20181231 59401-016_a7e59d57-fe13-4d76-89c7-238d3ff611c1 59401-016 HUMAN OTC DRUG Sallys Box Friendly Collagen Eye Patch Glycerin CREAM TOPICAL 20150105 UNAPPROVED DRUG OTHER Imine Co., Ltd GLYCERIN .9 g/9g N 20181231 59401-018_0fbffd24-e461-4512-8cd2-bd4bbec377d9 59401-018 HUMAN OTC DRUG Sallys Box Gold Snail Hydrogel Mask Adenosine CREAM TOPICAL 20150105 UNAPPROVED DRUG OTHER Imine Co., Ltd ADENOSINE .01 g/25g N 20181231 59401-021_6c0a57e3-cf95-4105-b7bc-582f83b14818 59401-021 HUMAN OTC DRUG ULTRUE The True Rich Cream - Lifting Hydrogel Mask Allantoin CREAM TOPICAL 20150216 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .0075 g/25g N 20181231 59401-022_e057a874-3009-4db9-b470-375d36c2f7d0 59401-022 HUMAN OTC DRUG ULTRUE The True Rich Cream - Revitalizing Hydrogel Mask Allantoin CREAM TOPICAL 20150225 UNAPPROVED DRUG OTHER Imine Co., Ltd ALLANTOIN .0075 g/25g N 20181231 59401-023_c3c97eee-c799-4f20-ab82-57ec2b1d2a24 59401-023 HUMAN OTC DRUG Manefit Beauty Planner Blackberry Firming Eye Mask ADENOSINE CREAM TOPICAL 20160304 UNAPPROVED DRUG OTHER Imine Co., Ltd. ADENOSINE .004 mg/10g N 20181231 59401-024_e05942dd-d944-4eab-99db-af51743bf483 59401-024 HUMAN OTC DRUG Manefit Beauty Planner Lily Brightening Eye Mask NIACINAMIDE CREAM TOPICAL 20160304 UNAPPROVED DRUG OTHER Imine Co., Ltd. NIACINAMIDE .2 mg/10g N 20181231 59417-101_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-101 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20140830 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59417-102_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-102 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20071210 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59417-103_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-103 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20070223 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59417-104_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-104 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20071210 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59417-105_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-105 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20070223 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59417-106_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-106 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20071210 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59417-107_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-107 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20070223 NDA NDA021977 Shire LLC LISDEXAMFETAMINE DIMESYLATE 70 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59417-115_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-115 HUMAN PRESCRIPTION DRUG Vyvanse LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE ORAL 20170128 NDA NDA208510 Shire LLC LISDEXAMFETAMINE DIMESYLATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59417-116_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-116 HUMAN PRESCRIPTION DRUG Vyvanse LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE ORAL 20170128 NDA NDA208510 Shire LLC LISDEXAMFETAMINE DIMESYLATE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59417-117_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-117 HUMAN PRESCRIPTION DRUG Vyvanse LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE ORAL 20170128 NDA NDA208510 Shire LLC LISDEXAMFETAMINE DIMESYLATE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59417-118_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-118 HUMAN PRESCRIPTION DRUG Vyvanse LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE ORAL 20170128 NDA NDA208510 Shire LLC LISDEXAMFETAMINE DIMESYLATE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59417-119_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-119 HUMAN PRESCRIPTION DRUG Vyvanse LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE ORAL 20170128 NDA NDA208510 Shire LLC LISDEXAMFETAMINE DIMESYLATE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59417-120_e77671ef-0cb9-4644-ab06-a9b10c75f8c7 59417-120 HUMAN PRESCRIPTION DRUG Vyvanse LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE ORAL 20170128 NDA NDA208510 Shire LLC LISDEXAMFETAMINE DIMESYLATE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 59426-001_e771a266-8743-4a45-87e3-ea88acf2e9cb 59426-001 HUMAN OTC DRUG Provodine providone iodine EMULSION TOPICAL 20140915 OTC MONOGRAPH NOT FINAL part333E Microdermis Corporation POVIDONE-IODINE 7.5 mg/mL N 20181231 59426-002_fe3ee5d2-630d-4532-ad0f-3895e11f5322 59426-002 HUMAN OTC DRUG Apocreme POVIDONE IODINE EMULSION TOPICAL 20150621 OTC MONOGRAPH FINAL part333C Microdermis Corporation POVIDONE-IODINE 75 mg/mL N 20181231 59427-001_13d96107-e053-472d-aeaf-98cd1e2773ef 59427-001 HUMAN OTC DRUG Origins A PERFECT WORLD AGE DEFENSE TINTED MOISTURIZER SPF 15 octinoxate, octisalate, and avobenzone LIQUID TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 2 mL/100mL; mL/100mL; mL/100mL N 20181231 59427-004_775a74fb-7d2a-4e15-a892-4e4a5db04664 59427-004 HUMAN OTC DRUG PLANTSCRIPTION SPF 15 ANTI-AGING FOUNDATION OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. OCTINOXATE; TITANIUM DIOXIDE 3; 1.4 mL/100mL; mL/100mL N 20181231 59427-005_c953a0ad-7e17-4c66-8d70-973bbae82d96 59427-005 HUMAN OTC DRUG SUPER SPOT REMOVER ACNE TREATMENT SALICYLIC ACID GEL TOPICAL 20120401 OTC MONOGRAPH FINAL part333D ORIGINS NATURAL RESOURCES INC. SALICYLIC ACID 2 mL/100mL N 20181231 59427-006_1b0d4e1d-1243-45ab-8260-06d43c345a19 59427-006 HUMAN OTC DRUG PLANTSCRIPTION ANTI-AGING BROAD SPECTRUM SPF 25 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE .02; .05; .075; .05; .03 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 59427-007_545830bf-5a00-497b-82a0-2a72c5cc413b 59427-007 HUMAN OTC DRUG PLANTSCRIPTION ANTI AGING OIL FREE BROAD SPECTRUM SPF 25 AVOBENZONE, OCTISALATE, and OCTOCRYLENE CREAM TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. AVOBENZONE; OCTISALATE; OCTOCRYLENE .0303; .0505; .02727 g/mL; g/mL; g/mL N 20181231 59427-008_84eec122-cf3a-41b0-ac2b-97629942a991 59427-008 HUMAN OTC DRUG BRIGHTER BY NATURE SPF 35 SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM HOMOSALATE, OCTISALATE, AVOBENZONE, and OCTOCRYLENE CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE .0498; .0498; .02988; .02689 g/mL; g/mL; g/mL; g/mL N 20181231 59427-009_618db662-ea3a-4732-b3b3-d69966feb475 59427-009 HUMAN OTC DRUG BRIGHTER BY NATURE SPF 30 CORRECTING MAKEUP BROAD SPECTRUM OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 1; 3 g/100g; g/100g; g/100g N 20181231 59427-011_e12a1ee2-574f-410e-9701-a909a38b8a07 59427-011 HUMAN OTC DRUG A PERFECT WORLD AGE DEFENSE EYE WITH WHITE TEA BROAD SPECTRUM SPF 20 TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. TITANIUM DIOXIDE; ZINC OXIDE 61.56; 41 mg/mL; mg/mL N 20181231 59427-110_2b3375e9-a9fa-494a-b5c8-3b57e5d13646 59427-110 HUMAN OTC DRUG SPOT REMOVER ACNE TREATMENT PADS SALICYLIC ACID LIQUID TOPICAL 20110401 OTC MONOGRAPH FINAL part333D ORIGINS NATURAL RESOURCES INC. SALICYLIC ACID .009506 g/100mL N 20181231 59427-111_82cf3063-6514-40d9-a896-5efd90773eaa 59427-111 HUMAN OTC DRUG SMARTY PLANTS CC SKIN COMPLEXION CORRECTOR BROAD SPECTRUM SPF 20 OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. OCTINOXATE; OCTISALATE; OXYBENZONE .079875; .0426; .03621 g/100mL; g/100mL; g/100mL N 20181231 59427-112_bd1989f1-e4fc-4891-8a96-08f0b5826396 59427-112 HUMAN OTC DRUG Dr. Andrew Weil for Origins MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING OIL FREE MOISTURIZER BROAD SPECTRUM SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE, and OCTOCRYLENE CREAM TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE .0498; .0498; .02988; .02689 g/mL; g/mL; g/mL; g/mL N 20181231 59427-113_ca9e2615-281b-4f0a-b30b-f0348ba1c733 59427-113 HUMAN OTC DRUG DR WEILS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45 SUNCREEN TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20160215 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. TITANIUM DIOXIDE; ZINC OXIDE 66.78; 14.96 mg/mL; mg/mL N 20181231 59427-575_ff21882b-d525-4eeb-a88c-4c8c4d77fde2 59427-575 HUMAN OTC DRUG COVER YOUR MOUTH SPF 8 LIP PROTECTOR TITANIUM DIOXIDE LIPSTICK TOPICAL 19990401 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. TITANIUM DIOXIDE 1.8 g/100g E 20171231 59427-701_1e451fa0-55d4-4010-9913-ea94e4ea0e68 59427-701 HUMAN OTC DRUG YOUTHTOPIA SKIN FIRMING FOUNDATION SPF 15 ZINC OXIDE, TITANIUM DIOXIDE LIQUID TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC ZINC OXIDE; TITANIUM DIOXIDE 3; 2.9 mL/100mL; mL/100mL E 20171231 59427-702_6ca8b040-803b-48ae-b867-f5b18fbb8a58 59427-702 HUMAN OTC DRUG A PERFECT WORLD SPF 25 AGE DEFENSE MOISTURIZER WITH WHITE TEA octisalate, avobenzone, octocrylene LOTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC OCTISALATE; AVOBENZONE; OCTOCRYLENE 5; 3; 2.7 mL/100mL; mL/100mL; mL/100mL N 20181231 59427-703_18948dd7-280e-4a00-9ab3-b52777800079 59427-703 HUMAN OTC DRUG BRIGHTER BY NATURE SPF 35 SKIN TONE CORRECTING MOISTURIZER HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 5; 5; 3; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 59427-704_afa6e232-5968-4298-b92d-8b3207e072ad 59427-704 HUMAN OTC DRUG BRIGHTER BY NATURE SPF 30 SKIN TONE CORRECTING MAKEUP OCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENE POWDER TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC OCTINOXATE; TITANIUM DIOXIDE; OCTOCRYLENE 7.5; 3; 1 g/100g; g/100g; g/100g E 20171231 59427-705_1f0b4411-e82b-49d6-af9c-8f04f9bde37a 59427-705 HUMAN OTC DRUG VITAZING ENERGY BOOSTING MOISTURIZER SPF 15 AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 3; 2.7 mL/100mL; mL/100mL; mL/100mL N 20181231 59427-706_55df77bb-d733-4a05-bae4-cc25656d5772 59427-706 HUMAN OTC DRUG A PERFECT WORLD SPF 35 UV BROAD SPECTRUM FACE PROTECTOR homosalate, octisalate, avobenzone, octocrylene LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 5; 5; 3; 2.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 59427-728_196e19b5-ae01-44cd-817c-da1c28735d60 59427-728 HUMAN OTC DRUG RAIN AND SHINE LIPTINT WITH SPF 10 SUNSCREEN OCTINOXATE LIPSTICK TOPICAL 20010901 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC OCTINOXATE 3.5 g/100g E 20171231 59427-761_9f603ab9-c46c-4600-ae58-808fe6d6d6bb 59427-761 HUMAN OTC DRUG NUDE AND IMPROVED BARE FACE MAKEUP SPF 15 TITANIUM DIOXIDE LOTION TOPICAL 20020101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. TITANIUM DIOXIDE 7.6 mL/100mL N 20181231 59427-783_92c44776-4b81-4c4f-b5f5-6c3ef790595a 59427-783 HUMAN OTC DRUG HAVE A NICE DAY SUPER CHARGED SPF 15 octinoxate and titanium dioxide CREAM TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part352 ORIGINS NATURAL RESOURCES INC. OCTINOXATE; TITANIUM DIOXIDE 7.5; 1 mL/100mL; mL/100mL N 20181231 59428-000_602df752-6236-37e6-e053-2a91aa0a0ce6 59428-000 HUMAN OTC DRUG Quadrydern Hydrocortisone CREAM TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Productos Zapotol Corp HYDROCORTISONE 10 mg/g N 20181231 59428-068_e06bd707-e470-4566-90c9-12a47164c436 59428-068 HUMAN OTC DRUG Pain Reliever Naproxen Sodium TABLET ORAL 20170531 ANDA ANDA079096 Productos Zapotol Corp. NAPROXEN SODIUM 220 mg/1 N 20181231 59428-135_aa069196-f6a1-43d6-bb77-b3f99b9eb085 59428-135 HUMAN OTC DRUG Zapotol Bacitracin Bacitracin CREAM TOPICAL 20140806 OTC MONOGRAPH FINAL part333B Zapatol Corp. BACITRACIN 500 [USP'U]/g N 20181231 59428-168_35a9e906-6c7f-44b1-b733-0d273e7649ab 59428-168 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20160531 ANDA ANDA079096 Productos Zapotol Corp. NAPROXEN SODIUM 220 mg/1 N 20181231 59428-359_b19b783a-4b82-4f68-a03c-b01c029efad8 59428-359 HUMAN OTC DRUG Zapotol Clotrimazole Clotrimazol CREAM TOPICAL 20120807 OTC MONOGRAPH FINAL part333C Zapotol Corp. CLOTRIMAZOLE 10 mg/100g N 20181231 59428-500_c8332db3-9bef-41d6-b5f7-2a8584f0ee7b 59428-500 HUMAN OTC DRUG Zapotol Dentidol Oral Analgesic Benzocaine, and Benzalkonium chloride GEL TOPICAL 20150518 OTC MONOGRAPH NOT FINAL part356 Productos Zapotol Corp. BENZOCAINE; BENZALKONIUM CHLORIDE 20; .1 g/100g; g/100g N 20181231 59428-720_cafa0cca-fe0d-440b-ac28-c0d5c6cb986b 59428-720 HUMAN OTC DRUG Multi-Symptom Relief Cold and Flu Multi-Symptom Relief Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140331 OTC MONOGRAPH FINAL part341 Productos Zapotol Corp. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 59430-101_ddd6f377-f7dd-445f-8604-4adef24f7ebd 59430-101 HUMAN OTC DRUG Nose clove AEROSOL NASAL 20130927 UNAPPROVED DRUG OTHER US EXCY-LINE INC. CLOVE .75 mg/100mL E 20171231 59434-001_503ef007-a5ac-4abc-90b1-b13bd0a05d08 59434-001 HUMAN OTC DRUG Ala-Septic Salicyclic Acid CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part358H Ala-Septic Pharmaceutical Research LLC SALICYLIC ACID 2 g/100g E 20171231 59448-001_271503b4-2892-0777-e054-00144ff8d46c 59448-001 HUMAN OTC DRUG Instant Hand Antiseptic ETHYL ALCOHOL GEL TOPICAL 20151218 OTC MONOGRAPH NOT FINAL part333E Anatomy Supply Partners, LLc ALCOHOL 62 mL/100mL N 20181231 59448-001_291eaa18-81f9-6907-e054-00144ff88e88 59448-001 HUMAN OTC DRUG Instant Hand Antiseptic ETHYL ALCOHOL GEL TOPICAL 20151218 OTC MONOGRAPH NOT FINAL part333E Anatomy Supply Partners, LLc ALCOHOL 62 mL/100mL N 20181231 59448-100_1da2c162-c9c9-471b-bf3b-15cbe63a0458 59448-100 HUMAN OTC DRUG NewYork-Presbyterian Amenity Sodium Monofluorophospate KIT 20130701 OTC MONOGRAPH FINAL part355 ASP Global, LLc N 20181231 59448-101_6185c6a0-ef48-4a09-8b5e-60a67b83c10a 59448-101 HUMAN OTC DRUG Gracie Square Hospital Amenity Sodium Monofluorophosphate KIT 20160118 OTC MONOGRAPH NOT FINAL part333E ASP Global, LLc N 20181231 59448-200_95294aaa-6669-4d27-a1e1-bb34bbf8fe06 59448-200 HUMAN OTC DRUG Northside Hospital Amenity Kit Alcohol and Sodium Monofluorophospate KIT 20160118 OTC MONOGRAPH NOT FINAL part333E ASP Global, LLc N 20181231 59448-201_735c78c7-0e59-4039-950c-0850a769d1db 59448-201 HUMAN OTC DRUG Northside Hospital Amenity Kit--GI Dept Alcohol KIT 20160118 OTC MONOGRAPH NOT FINAL part333E ASP Global, LLc N 20181231 59448-202_e0daeb2b-2636-4c09-9b1f-10510d31a059 59448-202 HUMAN OTC DRUG Northside Hospital Natural Mothers Bag Alcohol and Sodium Monofluorophospate KIT 20170415 OTC MONOGRAPH NOT FINAL part333E ASP Global, LLc N 20181231 59448-203_d0cbe3eb-71e5-4954-8607-6e3e4e0ce225 59448-203 HUMAN OTC DRUG Northside Hospital C-Section Mothers Bag Alcohol and Sodium Monofluorophospate KIT 20170415 OTC MONOGRAPH NOT FINAL part333E ASP Global, LLc N 20181231 59448-204_e21076de-f03f-410b-b468-12364c99d8b0 59448-204 HUMAN OTC DRUG Northside Hospital Bereavement ALCOHOL and Sodium Monofluorophosphate KIT 20171019 OTC MONOGRAPH NOT FINAL part333E ASP Global, LLc N 20181231 59448-205_84454d28-21c1-4ec6-84bf-2dcae590f2bf 59448-205 HUMAN OTC DRUG Northside Hospital Mothers Bag ALCOHOL and SODIUM MONOFLUOROPHOSPHATE KIT 20171019 OTC MONOGRAPH NOT FINAL part333E ASP Global, LLc N 20181231 59448-206_d4c82fae-5268-4fcb-ab21-77bcdc3f3bcc 59448-206 HUMAN OTC DRUG Northside Hospital H.E.A.R.T. Strings Bag ALCOHOL and SODIUM MONOFLUOROPHOSPHATE KIT 20171120 OTC MONOGRAPH NOT FINAL part333E ASP Global, LLc N 20181231 59448-300_601abd2a-3363-4d9b-818c-8ceef40e9e4d 59448-300 HUMAN OTC DRUG Memorial Sloan Kettering Cancer Center Amenity Kit Sodium Monofluorophosphate KIT 20170401 OTC MONOGRAPH NOT FINAL part333E ASP Global, LLc N 20181231 59450-001_6c484415-9912-a0e0-91aa-1e4e1c9afa6c 59450-001 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150825 NDA NDA020076 The Kroger Co. NICOTINE 7 mg/24h N 20181231 59450-002_6c484415-9912-a0e0-91aa-1e4e1c9afa6c 59450-002 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150825 NDA NDA020076 The Kroger Co. NICOTINE 14 mg/24h N 20181231 59450-003_6c484415-9912-a0e0-91aa-1e4e1c9afa6c 59450-003 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150825 NDA NDA020076 The Kroger Co. NICOTINE 21 mg/24h N 20181231 59450-012_240c2f82-b3bc-b27e-614b-159b1681107e 59450-012 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium 20.6mg Capsules CAPSULE, DELAYED RELEASE ORAL 20160101 ANDA ANDA078878 The Kroger Co. OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 59450-034_4eb334a6-f4f8-4a27-9889-5840a523bb54 59450-034 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL part333B The Kroger Co. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 59450-100_68443045-9212-4f30-841e-61906ccec922 59450-100 HUMAN OTC DRUG Kroger Waterless Hand Sanitizer With Aloe With Moisturizers And Vitamin E ALCOHOL GEL TOPICAL 20091210 OTC MONOGRAPH NOT FINAL part333 The Kroger Co. ALCOHOL 62 mL/100mL E 20171231 59450-200_8f44fece-a368-4a2e-b825-b3d52e991a2f 59450-200 HUMAN OTC DRUG Kroger Waterless Hand Sanitizer Citrus Scent With Moisturizers And Vitamin E ALCOHOL GEL TOPICAL 20091210 OTC MONOGRAPH NOT FINAL part333 The Kroger Co. ALCOHOL 62 mL/100mL E 20171231 59450-223_3bce4f40-87f4-4f61-b8c9-daac3f956693 59450-223 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 THE KROGER CO ALCOHOL 62 mL/100mL N 20181231 59450-231_7ddd1261-83ab-45be-aff9-d7fd5e0e1ae8 59450-231 HUMAN OTC DRUG WATERLESS HAND SANITIZER CITRUS SCENT ETHYL ALCOHOL GEL TOPICAL 20110620 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 62 mL/100mL N 20181231 59450-231_d34ac523-8ce0-4a52-8d71-51edf78c91f1 59450-231 HUMAN OTC DRUG WATERLESS HAND SANITIZER CITRUS SCENT ETHYL ALCOHOL GEL TOPICAL 20110620 OTC MONOGRAPH NOT FINAL part333E THE KROGER COMPANY ALCOHOL 62 mL/100mL N 20181231 59450-310_c0cc84cb-0d42-48f2-b019-312faec6db6c 59450-310 HUMAN OTC DRUG SKIN CARE LOTION EXTRA STRENGTH DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 THE KROGER CO DIMETHICONE 1 mL/100mL N 20181231 59450-315_764b7c7d-32ed-4115-8aae-589869dea072 59450-315 HUMAN OTC DRUG SKIN CARE EXTRA STRENGTH DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 THE KROGER CO DIMETHICONE 1 mL/100mL N 20181231 59450-823_268d8196-4b85-4382-8f93-cf126debb6a7 59450-823 HUMAN OTC DRUG Triple Antibiotic Plus Maximum Strength bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hcl OINTMENT TOPICAL 20080701 OTC MONOGRAPH FINAL part333B The Kroger Co. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g E 20171231 59460-0001_09f2249e-d76a-4bc3-a0fa-ac5270a24a88 59460-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Detroit Oxygen & Medical Equipment Co. OXYGEN 99 L/100L E 20171231 59465-210_186aadd3-2cb6-4de4-99b1-2371613e248d 59465-210 HUMAN OTC DRUG ThyroShield Potassium Iodide SOLUTION ORAL 20140901 ANDA ANDA077218 Arco Pharmaceuticals LLC POTASSIUM IODIDE 65 mg/mL E 20171231 59467-318_00ac0296-f6ef-4657-bd3b-c1c405ea4015 59467-318 HUMAN PRESCRIPTION DRUG MITIGARE Colchicine CAPSULE ORAL 20141001 NDA NDA204820 Hikma Americas, Inc. COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20181231 59469-005_b8405a98-eebe-4cd3-8b1a-dd6d7c2953a2 59469-005 HUMAN OTC DRUG AILGENO Amanita muscaria Fruiting Body, Arsenic trioxide, Milk Thistle, Ceanothus americanus Leaf, Cinchona officinalis Bark, Glechoma hederacea Flowering Top, Grindelia hirsutula whole, and Sodium chloride SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH AMANITA MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; MILK THISTLE; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; GLECHOMA HEDERACEA FLOWERING TOP; GRINDELIA HIRSUTULA WHOLE; SODIUM CHLORIDE 4; 6; 15; 4; 6; 6; 6; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-014_78dd1a10-3b1a-495b-a134-46d9c55d68fe 59469-014 HUMAN OTC DRUG MUCAN Amanita muscaria Fruiting Body, Garlic, Aristolochia clematitis Whole, Simaba Cedron Seed, Goldenseal, Okoubaka aubrevillei Bark, and Cynanchum Vincetoxicum Leaf SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH AMANITA MUSCARIA FRUITING BODY; GARLIC; ARISTOLOCHIA CLEMATITIS WHOLE; SIMABA CEDRON SEED; GOLDENSEAL; OKOUBAKA AUBREVILLEI BARK; CYNANCHUM VINCETOXICUM LEAF 6; 6; 12; 6; 12; 6; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-024_2c77a0d6-e75a-4173-87c4-2a512a79c45a 59469-024 HUMAN OTC DRUG LacticPlus Lactic Acid, DL- SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH LACTIC ACID, DL- 200 [hp_X]/100mL N 20181231 59469-032_e78ff038-b21f-4e65-804b-6c082edd6688 59469-032 HUMAN OTC DRUG OKOUBAKA Okoubaka aubrevillei Bark SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Natuheilmittel GmbH OKOUBAKA AUBREVILLEI BARK 2 [hp_X]/50mL N 20181231 59469-038_8e9bb16c-3fb4-40ab-95ee-8cf42950722b 59469-038 HUMAN OTC DRUG Zellulisan horse chestnut, arnica montana, betula pendula leaf, hedera helix flowering twig, ledum palustre twig, melilotus officinalis top, toxicodendron pubescens leaf, and sulfur OINTMENT TOPICAL 20110220 UNAPPROVED HOMEOPATHIC Pekana-Naturheilmittel GmbH HORSE CHESTNUT; ARNICA MONTANA; BETULA PENDULA LEAF; HEDERA HELIX FLOWERING TWIG; LEDUM PALUSTRE TWIG; MELILOTUS OFFICINALIS TOP; TOXICODENDRON PUBESCENS LEAF; SULFUR 4; 8; 8; 6; 3; 4; 8; 15 [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g N 20181231 59469-046_d2801998-dbaa-4480-bbde-1d7c5f5d90d1 59469-046 HUMAN OTC DRUG CITRIPLUS Juglans regia Whole and Anhydrous Citric Acid SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Natuheilmittel GmbH JUGLANS REGIA WHOLE; ANHYDROUS CITRIC ACID 4; 200 [hp_X]/100mL; [hp_X]/100mL N 20181231 59469-047_fdf483bc-2a81-46f1-8ece-f9d5377706f8 59469-047 HUMAN OTC DRUG FORMIPLUS Artemisia abrotanum Flowering Top and Formic Acid SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ARTEMISIA ABROTANUM FLOWERING TOP; FORMIC ACID 4; 200 [hp_X]/100mL; [hp_X]/100mL N 20181231 59469-050_f1dd9a0b-314f-4371-8b25-564d221e63ef 59469-050 HUMAN OTC DRUG RADINEX Onion, Arctium lappa Root, Bellis Perennis, Glechoma hederacea Flowering Top, Hedera helix Flowering Twig, Juglans regia Whole, Sempervivum tectorum Leaf, and Viscum album Fruiting Top SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ONION; ARCTIUM LAPPA ROOT; BELLIS PERENNIS; GLECHOMA HEDERACEA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; JUGLANS REGIA WHOLE; SEMPERVIVUM TECTORUM LEAF; VISCUM ALBUM FRUITING TOP 2; 3; 4; 6; 4; 6; 12; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL N 20181231 59469-058_01d45e28-0073-4e87-ae91-fcf881111ae1 59469-058 HUMAN OTC DRUG HELMIN Onion, Artemisia abrotanum Flowering Top, Artemisia cina Pre-Flowering Top, Cupric Oxide, Okoubaka aubrevillei Bark, Schoenocaulon officinale Seed, and Spigelia Anthelmia SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ONION; ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA CINA PRE-FLOWERING TOP; CUPRIC OXIDE; OKOUBAKA AUBREVILLEI BARK; SCHOENOCAULON OFFICINALE SEED; SPIGELIA ANTHELMIA 6; 8; 12; 12; 4; 6; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-059_dc296779-722c-46ac-8683-607772ebe962 59469-059 HUMAN OTC DRUG FEPYR Aconitum Napellus, Silver Nitrate, Arsenic Trioxide, Bryonia Dioica Root, Cinchona Officinalis Bark, Eupatorium perfoliatum Flowering Top, Lachesis Muta Venom, and Cynanchum Vincetoxicum Leaf SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BRYONIA DIOICA ROOT; CINCHONA OFFICINALIS BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; LACHESIS MUTA VENOM; CYNANCHUM VINCETOXICUM LEAF 4; 4; 6; 4; 3; 2; 7; 2 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-060_6b4d105c-101c-4542-8e7d-7d74e6545ac1 59469-060 HUMAN OTC DRUG SUPREN Arsenic Trioxide, Sulfuric Acid, Chamaelirium luteum Root, Goldenseal, Wood Creosote, Lemna minor, Magnesium fluoride, and Silicon Dioxide SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ARSENIC TRIOXIDE; SULFURIC ACID; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; WOOD CREOSOTE; LEMNA MINOR; MAGNESIUM FLUORIDE; SILICON DIOXIDE 12; 8; 12; 12; 12; 12; 12; 12 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL N 20181231 59469-066_f7e43e28-8788-4ced-b8e6-125fc1b597c3 59469-066 HUMAN OTC DRUG KELAN Silicon Dioxide, Arnica montana Root, Graphite, Hypericum Perforatum, Ledum Palustre Twig, Magnesium fluoride, Magnesium Sulfate Heptahydrate, and Ruta graveolens Flowering Top OINTMENT CUTANEOUS 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH SILICON DIOXIDE; ARNICA MONTANA ROOT; GRAPHITE; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM FLUORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; RUTA GRAVEOLENS FLOWERING TOP 6; 12; 6; 6; 12; 12; 12; 12 [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g N 20181231 59469-101_50df9617-6be6-4e48-a49c-9dc6af4433f0 59469-101 HUMAN OTC DRUG apo-PULM Onion, Bryonia Dioica Root, Hedera helix Flowering Twig, Hyoscyamus Niger, Phosphorus, Polygala senega Root, Antimony potassium tartrate, and Pulmonaria officinalis Whole SYRUP ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ONION; BRYONIA DIOICA ROOT; HEDERA HELIX FLOWERING TWIG; HYOSCYAMUS NIGER; PHOSPHORUS; POLYGALA SENEGA ROOT; ANTIMONY POTASSIUM TARTRATE; PULMONARIA OFFICINALIS WHOLE 4; 4; 8; 4; 10; 4; 6; 4 [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL N 20181231 59469-102_f42256be-fd40-4ac7-a2db-c1013220f8b5 59469-102 HUMAN OTC DRUG apo-STOM Antimony trisulfide, Atropa bella-donna Flowering Top, Colchicum autumnale Bulb, Citrullus colocynthis Fruit Pulp, Sodium phosphate, Strychnos nux-vomica Seed, Robinia pseudoacacia Bark, and Achillea millefolium Flowering Top SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ANTIMONY TRISULFIDE; ATROPA BELLA-DONNA FLOWERING TOP; COLCHICUM AUTUMNALE BULB; CITRULLUS COLOCYNTHIS FRUIT PULP; SODIUM PHOSPHATE; STRYCHNOS NUX-VOMICA SEED; ROBINIA PSEUDOACACIA BARK; ACHILLEA MILLEFOLIUM FLOWERING TOP 8; 4; 6; 4; 4; 4; 6; 2606 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL N 20181231 59469-103_f4ebc120-6c44-40c8-87bd-fb578610834a 59469-103 HUMAN OTC DRUG apo-STRUM calcium fluoride, conium maculatum flowering top, lophophytum leandrii, hedera helix flowering twig, magnesium carbonate, cytisus scoparius flowering top, crataegus fruit, and galium aparine SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH CALCIUM FLUORIDE; CONIUM MACULATUM FLOWERING TOP; LOPHOPHYTUM LEANDRII; HEDERA HELIX FLOWERING TWIG; MAGNESIUM CARBONATE; CYTISUS SCOPARIUS FLOWERING TOP; CRATAEGUS FRUIT; GALIUM APARINE 8; 6; 4; 3; 8; 6; 486; 584 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; mg/50mL N 20181231 59469-104_79330c47-fada-4ed5-8aec-615a35c6882b 59469-104 HUMAN OTC DRUG apo-TUSS Arum Maculatum Root, Bryonia Dioica Root, Protortonia Cacti, Cupric Acetate, Gelsemium sempervirens Root, Hedera helix Flowering Twig, Lactuca virosa, and Horseradish SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ARUM MACULATUM ROOT; BRYONIA DIOICA ROOT; PROTORTONIA CACTI; CUPRIC ACETATE; GELSEMIUM SEMPERVIRENS ROOT; HEDERA HELIX FLOWERING TWIG; LACTUCA VIROSA; HORSERADISH 4; 4; 2; 4; 4; 6; 4; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-106_f9473982-ffc8-4fbc-825f-4f98b074e1bf 59469-106 HUMAN OTC DRUG apo-HEPAT Chionanthus virginicus Bark, Iberis amara Seed, Lycopodium clavatum Spore, Mandragora officinarum Root, Phosphorus, Peumus boldus Leaf, Cynara scolymus Whole, and Taraxacum officinale Whole SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH CHIONANTHUS VIRGINICUS BARK; IBERIS AMARA SEED; LYCOPODIUM CLAVATUM SPORE; MANDRAGORA OFFICINARUM ROOT; PHOSPHORUS; PEUMUS BOLDUS LEAF; CYNARA SCOLYMUS WHOLE; TARAXACUM OFFICINALE WHOLE 2; 6; 4; 12; 10; 6; 8; 8 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-107_33d3379f-9b6a-4c1b-969d-b9b42d0e1509 59469-107 HUMAN OTC DRUG apo-INFEKT Ailanthus altissima Whole, Silver Nitrate, Cinchona Officinalis Bark, Lachesis Muta Venom, Cynanchum Vincetoxicum Leaf, Echinacea, unspecified, Marrubium Vulgare, and Nasturtium officinale Whole SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH AILANTHUS ALTISSIMA WHOLE; SILVER NITRATE; CINCHONA OFFICINALIS BARK; LACHESIS MUTA VENOM; CYNANCHUM VINCETOXICUM LEAF; ECHINACEA, UNSPECIFIED; MARRUBIUM VULGARE; NASTURTIUM OFFICINALE WHOLE 3; 6; 8; 12; 6; 12; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-108_04a69b4a-f67f-46d9-b600-2eb0003b0433 59469-108 HUMAN OTC DRUG BRONCHI-PERTU Bryonia Dioica Root, Protortonia Cacti, Guaiacum officinale Resin, Oenanthe Aquatica Fruit, Phosphorus, Antimony Potassium Tartrate, Usnea barbata, and Grindelia Hirsutula Whole SYRUP ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH BRYONIA DIOICA ROOT; PROTORTONIA CACTI; GUAIACUM OFFICINALE RESIN; OENANTHE AQUATICA FRUIT; PHOSPHORUS; ANTIMONY POTASSIUM TARTRATE; USNEA BARBATA; GRINDELIA HIRSUTULA WHOLE 3; 2; 3; 4; 6; 4; 12; 8 [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL N 20181231 59469-109_1d497f4c-996e-4a19-a98b-c05b88861c01 59469-109 HUMAN OTC DRUG CARDINORMA Arnica montana Root, Activated Charcoal, Potassium carbonate, Lachesis Muta Venom, Nerium oleander Leaf, Tobacco Leaf, Peumus boldus Leaf, and Crataegus Fruit SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ARNICA MONTANA ROOT; ACTIVATED CHARCOAL; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; NERIUM OLEANDER LEAF; TOBACCO LEAF; PEUMUS BOLDUS LEAF; CRATAEGUS FRUIT 4; 8; 4; 8; 4; 6; 4; 787 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL N 20181231 59469-110_190ea3fd-a8f3-4f40-a235-a4e6d2866953 59469-110 HUMAN OTC DRUG DALEKTRO N Silver nitrate, Oyster Shell Calcium Carbonate, Crude, Cobaltous Nitrate Hexahydrate, Cupric Acetate, Iron, Potassium carbonate, Magnesium chloride, Manganese Acetate Tetrahydrate, Selenium, Silicon Dioxide, and Zinc Phosphide SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Natruheilmittel GmbH SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COBALTOUS NITRATE HEXAHYDRATE; CUPRIC ACETATE; IRON; POTASSIUM CARBONATE; MAGNESIUM CHLORIDE; MANGANESE ACETATE TETRAHYDRATE; SELENIUM; SILICON DIOXIDE; ZINC PHOSPHIDE 4; 6; 6; 12; 6; 4; 4; 8; 12; 12; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-111_3f107c1d-45ab-4fde-935e-6f38212011b6 59469-111 HUMAN OTC DRUG DERCUT Helianthemum canadense, Centella asiatica Flowering Top, Daphne mezereum Bark, Ranunculus Bulbosus, Smilax Regelii Root, Fumaria officinalis Flowering Top, Ledum Palustre Twig, and Viola tricolor SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH HELIANTHEMUM CANADENSE; CENTELLA ASIATICA FLOWERING TOP; DAPHNE MEZEREUM BARK; RANUNCULUS BULBOSUS; SMILAX REGELII ROOT; FUMARIA OFFICINALIS FLOWERING TOP; LEDUM PALUSTRE TWIG; VIOLA TRICOLOR 3; 4; 12; 4; 12; 6; 6; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-112_0bbbe3b9-a1f6-4fa7-a1d8-976e48cc1f9b 59469-112 HUMAN OTC DRUG ITIRES Barium Carbonate, Calcium Iodide, Helianthemum canadense, Conium maculatum Flowering Top, Scrophularia nodosa, Echinacea, unspecified, Galium Aparine, and Juglans regia Whole SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH BARIUM CARBONATE; CALCIUM IODIDE; HELIANTHEMUM CANADENSE; CONIUM MACULATUM FLOWERING TOP; SCROPHULARIA NODOSA; ECHINACEA, UNSPECIFIED; GALIUM APARINE; JUGLANS REGIA WHOLE 8; 8; 12; 6; 4; 12; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-113_35212c00-dc59-4244-a7e9-d43447c66976 59469-113 HUMAN OTC DRUG KLIFEM Aletris farinosa Root, Graphite, Chamaelirium luteum Root, Pilocarpus Jaborandii Leaf, Lachesis Muta Venom, Anemone pratensis Flowering Top, Sanguinaria canadensis Root, and Lamium album Flowering Top SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ALETRIS FARINOSA ROOT; GRAPHITE; CHAMAELIRIUM LUTEUM ROOT; PILOCARPUS JABORANDII LEAF; LACHESIS MUTA VENOM; ANEMONE PRATENSIS FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; LAMIUM ALBUM FLOWERING TOP 2; 8; 3; 3; 6; 3; 6; 1475 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL N 20181231 59469-115_e3c3c02e-8204-48f2-a580-e07da4d06635 59469-115 HUMAN OTC DRUG OPSONAT Silver Nitrate, Sulfuric Acid, Bellis Perennis, Lytta vesicatoria, Gratiola officinalis, Goldenseal, Lachesis Muta Venom, and Glechoma hederacea Flowering Top SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH SILVER NITRATE; SULFURIC ACID; BELLIS PERENNIS; LYTTA VESICATORIA; GRATIOLA OFFICINALIS; GOLDENSEAL; LACHESIS MUTA VENOM; GLECHOMA HEDERACEA FLOWERING TOP 4; 4; 1; 4; 4; 4; 7; 801 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL N 20181231 59469-116_8e1a1fc5-4234-4ae5-a426-ab3dd69bf536 59469-116 HUMAN OTC DRUG PROALLER Ailanthus altissima Whole, Okoubaka aubrevillei Bark, Euphrasia Stricta, Gratiola officinalis, Juglans regia Whole, Smilax Regelii Root, and Taraxacum officinale Whole SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel AILANTHUS ALTISSIMA WHOLE; OKOUBAKA AUBREVILLEI BARK; EUPHRASIA STRICTA; GRATIOLA OFFICINALIS; JUGLANS REGIA WHOLE; SMILAX REGELII ROOT; TARAXACUM OFFICINALE WHOLE 4; 3; 3; 4; 6; 8; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-117_64110cfd-0719-4255-a674-79e5fb04e79f 59469-117 HUMAN OTC DRUG RENELIX Benzoic Acid, Nitric Acid, Apis mellifera, Berberis Vulgaris Root Bark, Colchicum autumnale Bulb, Protortonia Cacti, Solidago virgaurea Flowering Top, and Capsella bursa-pastoris Top SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH BENZOIC ACID; NITRIC ACID; APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; COLCHICUM AUTUMNALE BULB; PROTORTONIA CACTI; SOLIDAGO VIRGAUREA FLOWERING TOP; CAPSELLA BURSA-PASTORIS TOP 4; 4; 4; 3; 12; 631; 2913; 510 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 59469-118_8f43218c-edc3-4be6-b820-1cc31cf3aa3f 59469-118 HUMAN OTC DRUG RICURA Paprika, Mercuric Sulfide, Wood Creosote, Luffa Operculata Fruit, Thuja Occidentalis Leafy Twig, Echinacea, Unspecified, Plantago Major Leaf, and Sanicula Europaea Top SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH PAPRIKA; MERCURIC SULFIDE; WOOD CREOSOTE; LUFFA OPERCULATA FRUIT; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; PLANTAGO MAJOR LEAF; SANICULA EUROPAEA TOP 4; 12; 6; 6; 6; 12; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-119_244aa11f-dfc4-4e98-8195-a37eebeb946e 59469-119 HUMAN OTC DRUG SEPTONSIL Ailanthus altissima Whole, Atropa bella-donna Flowering Top, Barium Carbonate, Lachesis Muta Venom, Phytolacca americana Root, Clematis recta Flowering Top, Echinacea, unspecified, and Teucrium scorodonia Flowering Top SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH AILANTHUS ALTISSIMA WHOLE; ATROPA BELLA-DONNA FLOWERING TOP; BARIUM CARBONATE; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; CLEMATIS RECTA FLOWERING TOP; ECHINACEA, UNSPECIFIED; TEUCRIUM SCORODONIA FLOWERING TOP 3; 4; 8; 8; 4; 1448; 6; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-120_11068c21-83fe-4ccb-893f-f26c8771795d 59469-120 HUMAN OTC DRUG TOXEX silver nitrate, bryonia dioica root, clematis recta flowering top, goldenseal, echinacea, unspecified, galium aparine, glechoma hederacea flowering top, and ledum palustre twig SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH SILVER NITRATE; BRYONIA DIOICA ROOT; CLEMATIS RECTA FLOWERING TOP; GOLDENSEAL; ECHINACEA, UNSPECIFIED; GALIUM APARINE; GLECHOMA HEDERACEA FLOWERING TOP; LEDUM PALUSTRE TWIG 4; 4; 3; 4; 12; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-121_3cb911c6-085c-4e0b-8f6a-431fdad5cfb2 59469-121 HUMAN OTC DRUG AKUTUR Benzoic Acid, Nitric Acid, Apis mellifera, Lytta vesicatoria, Populus tremuloides Bark, Anemone pratensis Flowering Top, Ginger, and Solidago virgaurea Flowering Top SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Nautrheilmittel GmbH BENZOIC ACID; NITRIC ACID; APIS MELLIFERA; LYTTA VESICATORIA; POPULUS TREMULOIDES BARK; ANEMONE PRATENSIS FLOWERING TOP; GINGER; SOLIDAGO VIRGAUREA FLOWERING TOP 4; 4; 3; 4; 2; 4; 3; 2208 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL N 20181231 59469-122_b3e904c8-27d4-4918-b5f5-53e4eec93d03 59469-122 HUMAN OTC DRUG FERRODONNA arsenic trioxide, ceanothus americanus leaf, cinchona officinalis bark, cobaltous nitrate, cupric sulfate, iron, manganese acetate, and sodium chloride SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ARSENIC TRIOXIDE; CEANOTHUS AMERICANUS LEAF; CINCHONA OFFICINALIS BARK; COBALTOUS NITRATE; CUPRIC SULFATE; IRON; MANGANESE ACETATE; SODIUM CHLORIDE 12; 5; 4; 6; 6; 12; 6; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-123_ec6fd9cb-c3ca-47eb-9a30-06307508805e 59469-123 HUMAN OTC DRUG SPECI-CHOL Chionanthus virginicus Bark, Eichhornia crassipes Whole, Hedera helix Flowering Twig, Iberis amara Seed, Iris versicolor Root, Nutmeg, Phosphorus, and Glechoma hederacea Flowering Top SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH CHIONANTHUS VIRGINICUS BARK; EICHHORNIA CRASSIPES WHOLE; HEDERA HELIX FLOWERING TWIG; IBERIS AMARA SEED; IRIS VERSICOLOR ROOT; NUTMEG; PHOSPHORUS; GLECHOMA HEDERACEA FLOWERING TOP 3; 2; 6; 3; 3; 4; 10; 698 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL N 20181231 59469-125_a5b64605-06ea-4758-b6f5-c5e31d914741 59469-125 HUMAN OTC DRUG apo-OEDEM Horse Chestnut, Apocynum cannabinum Root, Convallaria majalis Flowering Top, Helleborus niger Root, Thuja occidentalis Leafy Twig, Sambucus nigra Flowering Top, Filipendula ulmaria Root, and Corn Silk SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel Gmbh HORSE CHESTNUT; APOCYNUM CANNABINUM ROOT; CONVALLARIA MAJALIS FLOWERING TOP; HELLEBORUS NIGER ROOT; THUJA OCCIDENTALIS LEAFY TWIG; SAMBUCUS NIGRA FLOWERING TOP; FILIPENDULA ULMARIA ROOT; CORN SILK 4; 2; 12; 4; 6; 4; 6; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-126_4772c77e-19f6-425b-a2c8-26e4283a024a 59469-126 HUMAN OTC DRUG VISCUM VISCUM ALBUM FRUITING TOP SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Natuheilmittel GmbH VISCUM ALBUM FRUITING TOP 4936 mg/50mL N 20181231 59469-127_467df289-ee7c-4484-9165-d31fa1ff26df 59469-127 HUMAN OTC DRUG SOMCUPIN Silver nitrate, Sodium Tetrachloroaurate, Arabica coffee bean, Delphinium staphisagria Seed, Lactuca virosa, Zinc Valerate Dihydrate, Eschscholzia californica flowering top, and Avena sativa Flowering Top SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH SILVER NITRATE; SODIUM TETRACHLOROAURATE; ARABICA COFFEE BEAN; DELPHINIUM STAPHISAGRIA SEED; LACTUCA VIROSA; ZINC VALERATE DIHYDRATE; ESCHSCHOLZIA CALIFORNICA FLOWERING TOP; AVENA SATIVA FLOWERING TOP 4; 6; 10; 4; 4; 5; 12; 2670 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL N 20181231 59469-128_d5e1248b-a512-41c9-9e63-675132d2aed9 59469-128 HUMAN OTC DRUG co-HYPERT Sodium tetrachloroaurate, Barium Carbonate, Anamirta cocculus seed, Iberis amara Seed, Magnesium Chloride, Ferula Sumbul Root, Melilotus officinalis Top, and Viscum album Fruiting Top SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH SODIUM TETRACHLOROAURATE; BARIUM CARBONATE; ANAMIRTA COCCULUS SEED; IBERIS AMARA SEED; MAGNESIUM CHLORIDE; FERULA SUMBUL ROOT; MELILOTUS OFFICINALIS TOP; VISCUM ALBUM FRUITING TOP 6; 8; 4; 4; 6; 6; 172; 984 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; mg/50mL N 20181231 59469-129_5203d375-f4a6-469a-9a37-0183c08c6dac 59469-129 HUMAN OTC DRUG coro-CALM ACONITUM NAPELLUS, SELENICEREUS GRANDIFLORUS WHOLE, ARABICA COFFEE BEAN, LOBELIA INFLATA, FERULA SUMBUL ROOT, CONVALLARIA MAJALIS Flowering TOP, CRATAEGUS FRUIT, and LEONURUS CARDIACA Flowering TOP SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ACONITUM NAPELLUS; SELENICEREUS GRANDIFLORUS WHOLE; ARABICA COFFEE BEAN; LOBELIA INFLATA; FERULA SUMBUL ROOT; CONVALLARIA MAJALIS FLOWERING TOP; CRATAEGUS FRUIT; LEONURUS CARDIACA FLOWERING TOP 6; 2; 10; 4; 4; 12; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-130_84c4b108-bfa4-4ccd-abec-b9c55bd16e5d 59469-130 HUMAN OTC DRUG apo-DOLOR Aconitum Napellus, Semecarpus anacardium Fruit, Bryonia Dioica Root, Gelsemium sempervirens Root, Menyanthes trifoliata, Piper methysticum Root, Schoenocaulon officinale Seed, and Spigelia Anthelmia SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ACONITUM NAPELLUS; SEMECARPUS ANACARDIUM FRUIT; BRYONIA DIOICA ROOT; GELSEMIUM SEMPERVIRENS ROOT; MENYANTHES TRIFOLIATA; PIPER METHYSTICUM ROOT; SCHOENOCAULON OFFICINALE SEED; SPIGELIA ANTHELMIA 12; 6; 3; 4; 3; 8; 3; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-131_a754bbb7-24a4-4856-a410-20173beb71e2 59469-131 HUMAN OTC DRUG GLAUTARAKT Gold Trichloride, Solanum dulcamara Top, Euphrasia Stricta, Nitroglycerin, Hedera helix Flowering Twig, Ruta graveolens Flowering Top, Tobacco Leaf, and Cynara scolymus Whole SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH GOLD TRICHLORIDE; SOLANUM DULCAMARA TOP; EUPHRASIA STRICTA; NITROGLYCERIN; HEDERA HELIX FLOWERING TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOBACCO LEAF; CYNARA SCOLYMUS WHOLE 6; 3; 2; 6; 8; 6; 6; 8 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-133_36362c3b-98a4-43c1-a929-d3e7e30a5777 59469-133 HUMAN OTC DRUG DEFAETON Peumus boldus Leaf, Dioscorea villosa Tuber, Strychnos ignatii Seed, Cynara scolymus Whole, Fumaria officinalis Whole, Frangula Alnus Bark, and Rheum officinale Root SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH PEUMUS BOLDUS LEAF; DIOSCOREA VILLOSA TUBER; STRYCHNOS IGNATII SEED; CYNARA SCOLYMUS WHOLE; FUMARIA OFFICINALIS WHOLE; FRANGULA ALNUS BARK; RHEUM OFFICINALE ROOT 6; 4; 6; 12; 6; 8; 8 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-134_e27a4248-e07d-48f8-a61a-8dd781872404 59469-134 HUMAN OTC DRUG apo-RHEUM ARNICA MONTANA ROOT, BRYONIA DIOICA ROOT, COLCHICUM AUTUMNALE BULB, SOLANUM DULCAMARA TOP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, GUAIACUM OFFICINALE RESIN, and TARAXACUM OFFICINALE WHOLE SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ARNICA MONTANA ROOT; BRYONIA DIOICA ROOT; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; GUAIACUM OFFICINALE RESIN; TARAXACUM OFFICINALE WHOLE 12; 4; 12; 12; 4; 6; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-135_c57e9275-29d8-4d37-9162-0e02e271f700 59469-135 HUMAN OTC DRUG PSY-stabil Phosphoric Acid, Amanita muscaria Fruiting Body, Semecarpus anacardium Fruit, Avena sativa Flowering Top, Cinchona officinalis Bark, Strychnos ignatii Seed, Schoenocaulon officinale Seed, and Piper methysticum Root SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH PHOSPHORIC ACID; AMANITA MUSCARIA FRUITING BODY; SEMECARPUS ANACARDIUM FRUIT; AVENA SATIVA FLOWERING TOP; CINCHONA OFFICINALIS BARK; STRYCHNOS IGNATII SEED; SCHOENOCAULON OFFICINALE SEED; PIPER METHYSTICUM ROOT 3; 6; 10; 1; 3; 4; 4; 8 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-136_66a4149d-4ee7-4e8d-9900-2868ad850811 59469-136 HUMAN OTC DRUG PROSCENAT Sulfuric Acid, Lytta vesicatoria, Conium maculatum Flowering Top, Selenium, Delphinium staphisagria Seed, Nasturtium officinale Whole, and Ononis spinosa Whole SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH SULFURIC ACID; LYTTA VESICATORIA; CONIUM MACULATUM FLOWERING TOP; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; NASTURTIUM OFFICINALE WHOLE; ONONIS SPINOSA WHOLE 4; 4; 4; 8; 4; 1852; 2564 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; mg/50mL N 20181231 59469-137_31607763-413d-460d-9579-1620bdb83f24 59469-137 HUMAN OTC DRUG GLUCORECT LACTIC ACID, DL-, SULFURIC ACID, ONION, CHIONANTHUS VIRGINICUS BARK, PHOSPHORUS, ZINC SULFATE HEPTAHYDRATE, CORN SILK, and SYZYGIUM CUMINI FRUIT SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH LACTIC ACID, DL-; SULFURIC ACID; ONION; CHIONANTHUS VIRGINICUS BARK; PHOSPHORUS; ZINC SULFATE HEPTAHYDRATE; CORN SILK; SYZYGIUM CUMINI FRUIT 6; 4; 4; 3; 10; 3; 669; 606 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; mg/50mL N 20181231 59469-138_c6caf074-433e-4c0d-b60e-9dbf5e2fc3f1 59469-138 HUMAN OTC DRUG ZELLULISAN arnica montana root, ledum palustre twig, toxicodendron pubescens shoot, sulfur, horse chestnut, betula pendula leaf, hedera helix flowering twig, and melilotus officinalis top OINTMENT CUTANEOUS 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ARNICA MONTANA ROOT; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS SHOOT; SULFUR; HORSE CHESTNUT; BETULA PENDULA LEAF; HEDERA HELIX FLOWERING TWIG; MELILOTUS OFFICINALIS TOP 8; 3; 8; 15; 4; 8; 6; 4 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g N 20181231 59469-139_144cdeb0-ba97-4b27-b526-0e8de550a392 59469-139 HUMAN OTC DRUG NEU-regen Silver nitrate, Cinchona officinalis Bark, Conium maculatum Flowering Top, Strychnos nux-vomica Seed, Delphinium staphisagria Seed, Piper methysticum Root, Avena sativa Flowering Top, and Asian Ginseng SYRUP ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH SILVER NITRATE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; DELPHINIUM STAPHISAGRIA SEED; PIPER METHYSTICUM ROOT; AVENA SATIVA FLOWERING TOP; ASIAN GINSENG 6; 4; 4; 4; 6; 8; 3061; 561 [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; mg/250mL; mg/250mL N 20181231 59469-140_3efef1eb-3cf2-4fc4-9cfa-2a798ff724cf 59469-140 HUMAN OTC DRUG MUNDIPUR Bryonia Dioica Root, Colchicum autumnale Bulb, Sodium Carbonate, Phytolacca americana Root, Berberis Vulgaris Root Bark, Cynara scolymus Whole, Harpagophytum procumbens Root, and Ledum Palustre Twig SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH BRYONIA DIOICA ROOT; COLCHICUM AUTUMNALE BULB; SODIUM CARBONATE; PHYTOLACCA AMERICANA ROOT; BERBERIS VULGARIS ROOT BARK; CYNARA SCOLYMUS WHOLE; HARPAGOPHYTUM PROCUMBENS ROOT; LEDUM PALUSTRE TWIG 4; 12; 4; 4; 6; 8; 12; 6 [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL N 20181231 59469-141_2e295e8f-534a-497e-aa56-0c455a6811a8 59469-141 HUMAN OTC DRUG HABIFAC Formic Acid, Nitric Acid, Baptisia tinctoria Root, Graphite, Calcium sulfide, Thuja occidentalis Leafy Twig, Cynanchum Vincetoxicum Leaf, and Glechoma hederacea Flowering Top SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH FORMIC ACID; NITRIC ACID; BAPTISIA TINCTORIA ROOT; GRAPHITE; CALCIUM SULFIDE; THUJA OCCIDENTALIS LEAFY TWIG; CYNANCHUM VINCETOXICUM LEAF; GLECHOMA HEDERACEA FLOWERING TOP 8; 6; 5; 8; 8; 10; 8; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-142_ed053ec4-cf16-464c-926a-fc20cb6ec314 59469-142 HUMAN OTC DRUG JUVE-CAL artemisia abrotanum flowering top, phosphoric acid, silver nitrate, barium carbonate, lycopodium clavatum spore, delphinium staphisagria seed, calcium hypophosphite, and cinchona officinalis bark SYRUP ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ARTEMISIA ABROTANUM FLOWERING TOP; PHOSPHORIC ACID; SILVER NITRATE; BARIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; DELPHINIUM STAPHISAGRIA SEED; CALCIUM HYPOPHOSPHITE; CINCHONA OFFICINALIS BARK 8; 4; 4; 12; 12; 4; 4; 8 [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL; [hp_X]/250mL N 20181231 59469-143_eb3b2c93-6a5f-437f-9db5-9d6730718fdf 59469-143 HUMAN OTC DRUG CLAUPAREST Araneus diadematus, Arnica montana Root, Cupric Acetate, Mandragora officinarum Root, Lead Acetate Anhydrous, Tobacco Leaf, Melilotus officinalis Top, and Ruta graveolens Flowering Top SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ARANEUS DIADEMATUS; ARNICA MONTANA ROOT; CUPRIC ACETATE; MANDRAGORA OFFICINARUM ROOT; LEAD ACETATE ANHYDROUS; TOBACCO LEAF; MELILOTUS OFFICINALIS TOP; RUTA GRAVEOLENS FLOWERING TOP 9; 4; 4; 6; 4; 6; 4; 4 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-144_82587bca-47e7-4560-b4fc-db0cbb56ffd5 59469-144 HUMAN OTC DRUG PLEVENT Peumus boldus Leaf, Cynara scolymus Whole, Equisetum arvense Top, Leonurus cardiaca Flowering Top, Solidago virgaurea Flowering Top, and Taraxacum officinale Whole SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH PEUMUS BOLDUS LEAF; CYNARA SCOLYMUS WHOLE; EQUISETUM ARVENSE TOP; LEONURUS CARDIACA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE WHOLE 8; 12; 6; 4; 12; 8 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-145_7d934bd8-65a5-4f96-9090-92df0c3f4d56 59469-145 HUMAN OTC DRUG UPELVA Cyclamen Purpurascens Tuber, Chamaelirium luteum Root, Hypericum Perforatum, Potassium carbonate, Delphinium staphisagria Seed, Datura stramonium Flowering Top, Viburnum opulus Bark, and Zanthoxylum Americanum Bark SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH CYCLAMEN PURPURASCENS TUBER; CHAMAELIRIUM LUTEUM ROOT; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM FLOWERING TOP; VIBURNUM OPULUS BARK; ZANTHOXYLUM AMERICANUM BARK 3; 4; 2; 4; 4; 10; 1; 3 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-148_810f24bb-d0f9-4db3-baca-571360ea9237 59469-148 HUMAN OTC DRUG INFLAMYAR Arnica montana Root, Bryonia Dioica Root, Guaiacum officinale Resin, Toxicodendron Pubescens Shoot, Bellis Perennis, Ledum Palustre Twig, Ruta graveolens Flowering Top, and Viscum album Fruiting Top OINTMENT CUTANEOUS 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ARNICA MONTANA ROOT; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; TOXICODENDRON PUBESCENS SHOOT; BELLIS PERENNIS; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; VISCUM ALBUM FRUITING TOP 12; 4; 4; 12; 8; 4; 6; 4 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g N 20181231 59469-149_2b32c3a7-49d4-4c65-a75b-80eb3d484854 59469-149 HUMAN OTC DRUG DEMYC spag. Ranunculus Bulbosus, Delphinium staphisagria Seed, Piper methysticum Root, Anagallis arvensis, Calendula officinalis Flowering Top, and Sage SOLUTION/ DROPS TOPICAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH RANUNCULUS BULBOSUS; DELPHINIUM STAPHISAGRIA SEED; PIPER METHYSTICUM ROOT; ANAGALLIS ARVENSIS; CALENDULA OFFICINALIS FLOWERING TOP; SAGE 5; 3; 8; 237; 806; 774 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 59469-151_267f947d-e1f2-49a0-9179-7f6e22c33334 59469-151 HUMAN OTC DRUG OTIDOLO Atropa bella-donna Flowering Top, Phytolacca americana Root, Anemone Pulsatilla, Matricaria Recutita Flowering Top, Echinacea angustifolia, and Plantago major Leaf SOLUTION/ DROPS AURICULAR (OTIC) 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ATROPA BELLA-DONNA FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; ANEMONE PULSATILLA; MATRICARIA RECUTITA FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; PLANTAGO MAJOR LEAF 2; 1; 2; 270; 90; 90 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; mg/10mL; mg/10mL; mg/10mL N 20181231 59469-152_45dfcea5-0b61-4ff4-8e21-15d3d8bc53dd 59469-152 HUMAN OTC DRUG CANGUST Horse Chestnut, Arnica montana Root, Gold Trichloride, Activated Charcoal, Lachesis Muta Venom, Prunus laurocerasus Leaf, Strophanthus gratus Seed, and Tobacco Leaf SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH HORSE CHESTNUT; ARNICA MONTANA ROOT; GOLD TRICHLORIDE; ACTIVATED CHARCOAL; LACHESIS MUTA VENOM; PRUNUS LAUROCERASUS LEAF; STROPHANTHUS GRATUS SEED; TOBACCO LEAF 2; 4; 6; 8; 6; 3; 4; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-153_705b7fb7-cc35-4cc9-aac1-421b5756d405 59469-153 HUMAN OTC DRUG OSS-regen Phosphoric Acid, Angostura Bark, Ferula Assa-Foetida Resin, Bellis Perennis, Bryonia Dioica Root, Guaiacum officinale Resin, Ruta graveolens Flowering Top, and Equisetum arvense Top SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH PHOSPHORIC ACID; ANGOSTURA BARK; FERULA ASSA-FOETIDA RESIN; BELLIS PERENNIS; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; RUTA GRAVEOLENS FLOWERING TOP; EQUISETUM ARVENSE TOP 3; 4; 3; 3; 4; 3; 3; 2481 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; mg/100mL N 20181231 59469-155_2495cbc0-cc24-4c89-9f79-e2cb31ed1011 59469-155 HUMAN OTC DRUG DERCUT Euphorbia Resinifera Resin, Goldenseal, Wood Creosote, Toxicodendron Pubescens Shoot, Sempervivum tectorum Leaf, Bellis Perennis, Vinca Minor, and Viola tricolor OINTMENT CUTANEOUS 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; WOOD CREOSOTE; TOXICODENDRON PUBESCENS SHOOT; SEMPERVIVUM TECTORUM LEAF; BELLIS PERENNIS; VINCA MINOR; VIOLA TRICOLOR 4; 3; 6; 8; 3; 8; 3; 2 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g N 20181231 59469-156_00067e80-da2b-4851-80ee-ed16cb5629a6 59469-156 HUMAN OTC DRUG DALEKTRO N Silver Nitrate, Oyster Shell Calcium Carbonate, Crude, Cobaltous Nitrate Hexahydrate, Cupric Acetate, Iron, Potassium carbonate, Magnesium chloride, Manganese Acetate Tetrahydrate, Selenium, Silicon Dioxide, and Zinc Phosphide SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Natruheilmittel GmbH SILVER NITRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COBALTOUS NITRATE HEXAHYDRATE; CUPRIC ACETATE; IRON; POTASSIUM CARBONATE; MAGNESIUM CHLORIDE; MANGANESE ACETATE TETRAHYDRATE; SELENIUM; SILICON DIOXIDE; ZINC PHOSPHIDE 4; 6; 6; 12; 6; 4; 4; 8; 12; 12; 12 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL N 20181231 59469-157_81ab56cf-3d59-4942-83d5-9afdf21db63b 59469-157 HUMAN OTC DRUG Thuja Thuja occidentalis leafy twig LIQUID ORAL 20050501 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH THUJA OCCIDENTALIS LEAFY TWIG 3 [hp_X]/50mL N 20181231 59469-158_45ebe914-6d83-4ad5-bb27-80bf53299030 59469-158 HUMAN OTC DRUG apo-ENTERIT Citrullus colocynthis Fruit Pulp, Podophyllum, Veratrum album Root, Artemisia abrotanum Flowering Top, Cynara scolymus Whole, and Potentilla anserina Flowering Top SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH CITRULLUS COLOCYNTHIS FRUIT PULP; PODOPHYLLUM; VERATRUM ALBUM ROOT; ARTEMISIA ABROTANUM FLOWERING TOP; CYNARA SCOLYMUS WHOLE; POTENTILLA ANSERINA FLOWERING TOP 4; 4; 4; 760; 2137; 1092 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 59469-161_ce0629ef-f745-4523-831f-cb38b318b6c7 59469-161 HUMAN OTC DRUG ITIRES Arnica montana Root, Calcium Fluoride, Calcium Iodide, Clematis recta Flowering Top, Scrophularia nodosa, Conium maculatum Flowering Top, Horse Chestnut, and Hedera helix Flowering Twig OINTMENT CUTANEOUS 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ARNICA MONTANA ROOT; CALCIUM FLUORIDE; CALCIUM IODIDE; CLEMATIS RECTA FLOWERING TOP; SCROPHULARIA NODOSA; CONIUM MACULATUM FLOWERING TOP; HORSE CHESTNUT; HEDERA HELIX FLOWERING TWIG 8; 8; 6; 3; 2; 3; 4; 6 [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g N 20181231 59469-163_4abeef5f-c3bd-4b26-ab31-3b681dda08a0 59469-163 HUMAN OTC DRUG PSY-stabil Phosphoric Acid, Amanita muscaria Fruiting Body, Semecarpus anacardium Fruit, Avena sativa Flowering Top, Cinchona officinalis Bark, Strychnos ignatii Seed, Schoenocaulon officinale Seed, and Piper methysticum Root SOLUTION/ DROPS ORAL 20081211 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH PHOSPHORIC ACID; AMANITA MUSCARIA FRUITING BODY; SEMECARPUS ANACARDIUM FRUIT; AVENA SATIVA FLOWERING TOP; CINCHONA OFFICINALIS BARK; STRYCHNOS IGNATII SEED; SCHOENOCAULON OFFICINALE SEED; PIPER METHYSTICUM ROOT 3; 6; 10; 1; 3; 4; 4; 8 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL N 20181231 59469-165_d3a939b5-1649-441c-9fb2-3238a0daf2c5 59469-165 HUMAN OTC DRUG INFLAMYAR Arnica montana Root, Bellis Perennis, Bryonia Dioica Root, Guaiacum officinale Resin, Ledum Palustre Twig, Ruta graveolens Flowering Top, Toxicodendron Pubescens Shoot, and Viscum album Fruiting Top SOLUTION/ DROPS ORAL 20080412 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH ARNICA MONTANA ROOT; BELLIS PERENNIS; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS SHOOT; VISCUM ALBUM FRUITING TOP 4; 4; 4; 6; 12; 4; 8; 4 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL N 20181231 59469-170_67966d85-9c7b-452a-8b6e-d952810dbca0 59469-170 HUMAN OTC DRUG Inflamyar arnica montana, bellis perennis, bryonia cretica subsp. dioica root, guaiacum officinale resin, ledum palustre twig, toxicodendron pubescens leaf, ruta graveolens flowering top, and viscum album fruit OINTMENT TOPICAL 20101201 UNAPPROVED HOMEOPATHIC Pekana-Naturheilmittel GmbH ARNICA MONTANA; BELLIS PERENNIS; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; VISCUM ALBUM FRUIT 12; 8; 4; 4; 4; 12; 6; 4 [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g; [hp_X]/35g N 20181231 59469-171_75f1322e-fb71-446d-a8df-74df8e963cee 59469-171 HUMAN OTC DRUG OPSONAT Silver Nitrate, Sulfuric Acid, Bellis Perennis, Lytta vesicatoria, Gratiola officinalis, Goldenseal, Lachesis Muta Venom, and Glechoma hederacea Flowering Top SOLUTION/ DROPS ORAL 20081122 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH SILVER NITRATE; SULFURIC ACID; BELLIS PERENNIS; LYTTA VESICATORIA; GRATIOLA OFFICINALIS; GOLDENSEAL; LACHESIS MUTA VENOM; GLECHOMA HEDERACEA FLOWERING TOP 4; 4; 1; 4; 4; 4; 7; 1602 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; mg/100mL N 20181231 59469-172_cae04890-51d7-4545-97e6-3fa7c5e00b8b 59469-172 HUMAN OTC DRUG Inflamyar ARNICA MONTANA, BELLIS PERENNIS, BRYONIA CRETICA SUBSP. DIOICA ROOT, GUAIACUM OFFICINALE RESIN, LEDUM PALUSTRE TWIG, RUTA GRAVEOLENS WHOLE, TOXICODENDRON PUBESCENS LEAF, and VISCUM ALBUM FRUIT PELLET ORAL 20110901 UNAPPROVED HOMEOPATHIC Pekana-Naturheilmittel GmbH ARNICA MONTANA; BELLIS PERENNIS; BRYONIA DIOICA ROOT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS WHOLE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUIT 4; 4; 4; 6; 12; 4; 8; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59469-201_38fcfc4f-a1da-4ab8-9dd6-55182fa13641 59469-201 HUMAN OTC DRUG BOLYM-EX Drops Benzoic Acid, Formic Acid, Aristolochia Clematitis Root, FERULA ASSA-FOETIDA RESIN, Avena Sativa Flowering Top, Berberis Vulgaris Root Bark, CALCIUM PHOSPHATE, UNSPECIFIED FORM, Capsella bursa-pastoris, Galium aparine, Daphne Mezereum Bark, and Piper Methysticum Root LIQUID ORAL 20150601 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH BENZOIC ACID; FORMIC ACID; ARISTOLOCHIA CLEMATITIS ROOT; FERULA ASSA-FOETIDA RESIN; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CALCIUM PHOSPHATE, UNSPECIFIED FORM; CAPSELLA BURSA-PASTORIS; GALIUM APARINE; DAPHNE MEZEREUM BARK; PIPER METHYSTICUM ROOT 5; 5; 24; 5; 4; 5; 8; 5; 5; 8; 10 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59469-203_a7ae21f1-8828-48d4-b01a-46cbe1ce61e9 59469-203 HUMAN OTC DRUG VULPUR Silver Nitrate, Armoracia rusticana whole, Cinnamomum verum whole, Wood Creosote, Capsella bursa-pastoris, Calendula Officinalis Flowering Top, Achillea Millefolium, and Salvia officinalis flowering top SOLUTION/ DROPS ORAL 20171001 UNAPPROVED HOMEOPATHIC PEKANA Naturheilmittel GmbH SILVER NITRATE; ARMORACIA RUSTICANA WHOLE; CINNAMOMUM VERUM WHOLE; WOOD CREOSOTE; CAPSELLA BURSA-PASTORIS; CALENDULA OFFICINALIS FLOWERING TOP; ACHILLEA MILLEFOLIUM; SALVIA OFFICINALIS FLOWERING TOP 6; 4; 12; 6; 4; 8; 8; 8 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59470-001_3ad1138f-e6bd-474c-b6f7-097348b0ea35 59470-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130501 UNAPPROVED MEDICAL GAS Steve Gulick, Inc. OXYGEN 990 mL/L E 20171231 59478-000_4dcf24e6-398d-4e5d-8307-5792c28052f0 59478-000 HUMAN OTC DRUG KeVUENO Pain Relieving CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part348 Prilumar Laboratorios CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 5; 10; 13 g/100g; g/100g; g/100g E 20171231 59494-1001_e40ce033-d3b5-4db8-989e-f488f0b29416 59494-1001 HUMAN OTC DRUG PAMO Kill Natural GINKGO BILOBA LEAF OIL LIQUID TOPICAL 20130708 UNAPPROVED DRUG OTHER GeoRim Pharmaceutical GINKGO BILOBA LEAF OIL 1 g/100mL E 20171231 59494-2001_2631a673-772e-4a87-ae03-eb23e017bf26 59494-2001 HUMAN OTC DRUG PAMO Kill Natural TRIPTERYGIUM WILFORDII WHOLE LIQUID TOPICAL 20131007 UNAPPROVED DRUG OTHER GeoRim Pharmaceutical TRIPTERYGIUM WILFORDII WHOLE 28 g/100mL E 20171231 59503-0544_e25373e9-a6c3-42ed-ab80-daf1c152f81c 59503-0544 HUMAN OTC DRUG Chemseptic CHLOROXYLENOL SOAP TOPICAL 20040330 OTC MONOGRAPH NOT FINAL part333E Rochester Midland Corporation CHLOROXYLENOL 3 mg/mL N 20181231 59503-2605_befd29f6-1eca-4e21-8e01-45e49c75f88a 59503-2605 HUMAN OTC DRUG Hand San ALCOHOL LIQUID TOPICAL 20180103 OTC MONOGRAPH NOT FINAL part333E Rochester Midland Corporation ALCOHOL .7 mL/mL N 20191231 59503-6265_ebc65360-e675-4c23-993c-e9809329fa11 59503-6265 HUMAN OTC DRUG Balma Septic Antiseptic Hand Wash BENZALKONIUM CHLORIDE SOAP TOPICAL 20170509 OTC MONOGRAPH NOT FINAL part333E Rochester Midland Corporation BENZALKONIUM CHLORIDE 25 mg/mL N 20181231 59503-6576_869a1b7d-b5ee-489a-9286-fc788279fe91 59503-6576 HUMAN OTC DRUG Antibac Foam Wash TRICLOSAN SOAP TOPICAL 20110927 OTC MONOGRAPH NOT FINAL part333E Rochester Midland Corporation TRICLOSAN 3 mg/mL E 20171231 59503-6585_bf881030-a909-43ca-9656-6a756ccb2e51 59503-6585 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part333E Rochester Midland Corporation ALCOHOL .62 mL/mL N 20181231 59528-0317_7231d9fa-3a3f-449a-9b75-81f864fa7504 59528-0317 HUMAN PRESCRIPTION DRUG NephPlex Rx multi vitamin/mineral supplement with ascorbic acid, niacin, pyridoxine, pantothenic acid, folic acid, riboflavin, thiamin, biotin, cobalamin and zinc. TABLET, COATED ORAL 19950701 UNAPPROVED DRUG OTHER Nephro-Tech, Inc. ASCORBIC ACID; NIACINAMIDE; ZINC OXIDE; PYRIDOXINE HYDROCHLORIDE; PANTOTHENIC ACID; RIBOFLAVIN; THIAMINE; FOLIC ACID; BIOTIN; COBALAMIN 60; 20; 12.5; 10; 10; 1.7; 1.5; 1; .3; .006 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 59528-0416_333a96c8-e217-48d0-ad35-1a561f8f33e6 59528-0416 HUMAN PRESCRIPTION DRUG MagneBind 400 Rx vitamin/mineral supplement with magnesium carbonate, calcium carbonate and folic acid TABLET, FILM COATED ORAL 19991018 UNAPPROVED DRUG OTHER Nephro-Tech, Inc. MAGNESIUM CARBONATE; CALCIUM CARBONATE; FOLIC ACID 115; 80; 1 mg/1; mg/1; mg/1 N 20181231 59528-1988_c655464c-57e1-4a14-b085-47fe646c3904 59528-1988 HUMAN PRESCRIPTION DRUG Vital-D Rx multi vitamin/mineral supplement containing vitamin C, vitamin D, vitamin E, thiamin, riboflavin, niacin, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid, selenium and zinc TABLET, COATED ORAL 20071101 UNAPPROVED DRUG OTHER Nephro-Tech, Inc. ASCORBIC ACID; CHOLECALCIFEROL; TOCOPHEROL; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; COBALAMIN; BIOTIN; PANTOTHENIC ACID; ZINC OXIDE; SELENOMETHIONINE 60; 2000; 35; 1.5; 1.7; 20; 10; 1; 6; 300; 10; 12.5; 70 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 59528-4456_a1d573c0-3355-4eb0-8447-b520052b666c 59528-4456 HUMAN PRESCRIPTION DRUG Nephron FA mineral/vitamin supplement TABLET, COATED ORAL 19921101 UNAPPROVED DRUG OTHER Nephro-Tech, Inc. IRON; ASCORBIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; PANTOTHENIC ACID; RIBOFLAVIN; THIAMINE; FOLIC ACID; BIOTIN; COBALAMIN 66; 40; 20; 10; 10; 1.7; 1.5; 1; .3; .006 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 59532-001_db430c4e-6e61-4bf3-b21d-c6f97236834e 59532-001 HUMAN OTC DRUG SHEZA GUSL FIRMING MASK PACK Niacinamide, Adenosine CREAM TOPICAL 20130809 UNAPPROVED DRUG OTHER PISATAP NIACINAMIDE; ADENOSINE 1; .02 g/50g; g/50g E 20171231 59534-001_283c6115-a140-4111-af4d-fdd7a58d724d 59534-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920502 UNAPPROVED MEDICAL GAS Richmond Oxygen Company Inc. OXYGEN 99 L/100L E 20171231 59534-002_b4c7e44e-6d06-4812-ba24-9658887bf092 59534-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19920502 NDA NDA206024 Richmond Oxygen Company Inc. NITROGEN 99 L/100L N 20181231 59535-0011_239ae403-232a-4b4e-9659-48de110187f7 59535-0011 HUMAN OTC DRUG Super Aqua Facial Foam Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .16 g/mL E 20171231 59535-0101_3e28f8c0-857a-197b-e054-00144ff88e88 59535-0101 HUMAN OTC DRUG PROPOLIS 39 CC ZINC OXIDE CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .0098 g/g E 20171231 59535-0111_937168a5-22fb-49f9-a764-f0ad475f15c1 59535-0111 HUMAN OTC DRUG Ultra Nutrition Night Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/mL E 20171231 59535-0121_3e28f8c0-8594-197b-e054-00144ff88e88 59535-0121 HUMAN OTC DRUG CLIV RYEOYUN SNOW WHITE Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-0131_3e2c802b-7939-5995-e054-00144ff8d46c 59535-0131 HUMAN OTC DRUG JEJUEN NOURISHING OPUNTIA ICE PACK Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-0141_50e012d5-dfec-330f-e054-00144ff88e88 59535-0141 HUMAN OTC DRUG DCS PORE TIGHTENING SERUM Glycerin LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 1 g/100mL N 20181231 59535-0151_9da264dc-3c0f-417e-8bca-5637918e2060 59535-0151 HUMAN OTC DRUG JEJUEN LOTUS PLACENTA EYE GLYCERIN LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3 g/100mL N 20181231 59535-0161_3e2c802b-7946-5995-e054-00144ff8d46c 59535-0161 HUMAN OTC DRUG BRTC Make Over Mask Empress GLYCERIN LIQUID TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4 g/100g N 20181231 59535-0171_3e2d2152-a6ee-2b20-e054-00144ff88e88 59535-0171 HUMAN OTC DRUG Volcanic Pore Heating GLYCERIN GEL TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 91.16 g/100mL N 20181231 59535-0201_6ccb1b45-8fcc-4b1b-b72f-ab1d2798c5ad 59535-0201 HUMAN OTC DRUG ACTIVE RESURGENCE SERUM GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 mg/mL E 20171231 59535-0202_32aff4b7-6c54-04fe-e054-00144ff88e88 59535-0202 HUMAN OTC DRUG JEJUEN BLACK BEAN FERMENT SERUM Glycerin LIQUID TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 10.013 g/100mL N 20181231 59535-0203_32b14080-96e1-24a6-e054-00144ff88e88 59535-0203 HUMAN OTC DRUG JEJUEN BLACK BEAN FERMENT SLEEPING Glycerin CREAM TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 8.013 g/100mL N 20181231 59535-0204_4feaf98e-a250-4eb1-e054-00144ff8d46c 59535-0204 HUMAN OTC DRUG JEJUEN RADIANCE TONER Glycerin GEL TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 11 g/100mL N 20181231 59535-0205_4feaf98e-a247-4eb1-e054-00144ff8d46c 59535-0205 HUMAN OTC DRUG JEJUEN RADIANCE Glycerin EMULSION TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 6 g/100mL N 20181231 59535-0206_32b27578-9141-56b1-e054-00144ff88e88 59535-0206 HUMAN OTC DRUG JEJUEN RADIANCE AMPOULE Glycerin LIQUID TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4.001 g/100mL N 20181231 59535-0207_32b2c9e5-f2f2-5fde-e054-00144ff88e88 59535-0207 HUMAN OTC DRUG JEJUEN RADIANCE YOUTH Glycerin CREAM TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 8.001 g/100mL N 20181231 59535-0208_4feaac20-317a-2490-e054-00144ff88e88 59535-0208 HUMAN OTC DRUG JEJUEN RADIANCE EYE Glycerin CREAM TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 8.001 g/100mL N 20181231 59535-0210_4feaac20-3171-2490-e054-00144ff88e88 59535-0210 HUMAN OTC DRUG JEJUEN RADIANCE FOAM CLEANSER Glycerin CREAM TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 18 g/100mL N 20181231 59535-0211_3b303b1a-373a-6b63-e054-00144ff88e88 59535-0211 HUMAN OTC DRUG CENTELLA REVIVING TONER NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20160223 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0212_3b2f9d94-597c-6111-e054-00144ff88e88 59535-0212 HUMAN OTC DRUG CENTELLA 90 AMPOULE NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20160223 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0213_3b2f9d94-5990-6111-e054-00144ff88e88 59535-0213 HUMAN OTC DRUG CENTELLA 80 EYE NIACINAMIDE, ADENOSINE CREAM TOPICAL 20160223 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0214_3b429454-a71d-68ba-e054-00144ff8d46c 59535-0214 HUMAN OTC DRUG CENTELLA 70 NIACINAMIDE, ADENOSINE CREAM TOPICAL 20160223 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0215_3fe6439e-9002-3000-e054-00144ff8d46c 59535-0215 HUMAN OTC DRUG CENTELLA SCAR GLYCERIN OINTMENT TOPICAL 20161028 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-0216_3b42d664-0e96-3785-e054-00144ff8d46c 59535-0216 HUMAN OTC DRUG CENTELLA 65 GREEN TEA PACK CENTELLA ASIATICA, GREEN TEA LEAF CREAM TOPICAL 20160223 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. CENTELLA ASIATICA; GREEN TEA LEAF 65; 1 g/100g; g/100g N 20181231 59535-0217_3b42d664-0ea2-3785-e054-00144ff8d46c 59535-0217 HUMAN OTC DRUG PROPOLIS CLEANSING MILK PROPOLIS WAX CREAM TOPICAL 20160223 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. PROPOLIS WAX .1 g/100mL N 20181231 59535-0218_3d879350-9e41-19fa-e054-00144ff88e88 59535-0218 HUMAN OTC DRUG PROPOLIS FOAM CLEANSER PROPOLIS WAX CREAM TOPICAL 20160830 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. PROPOLIS WAX .1 g/100mL N 20181231 59535-0219_3b4312e4-d8d1-203c-e054-00144ff88e88 59535-0219 HUMAN OTC DRUG PROPOLIS SOFTENING TONER PROPOLIS WAX LIQUID TOPICAL 20160830 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. PROPOLIS WAX; NIACINAMIDE; ADENOSINE 1; 2; .04 g/100mL; g/100mL; g/100mL N 20181231 59535-0221_3b43c6cd-2416-359f-e054-00144ff88e88 59535-0221 HUMAN OTC DRUG PROPOLIS 80 PROPOLIS WAX, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20160830 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. PROPOLIS WAX; NIACINAMIDE; ADENOSINE 80; 2; .04 g/100mL; g/100mL; g/100mL N 20181231 59535-0222_3b429454-a72b-68ba-e054-00144ff8d46c 59535-0222 HUMAN OTC DRUG PROPOLIS 80 SLEEPING PACK PROPOLIS WAX, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20160830 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. PROPOLIS WAX; NIACINAMIDE; ADENOSINE 80; 2; .04 g/100mL; g/100mL; g/100mL N 20181231 59535-0223_3b6a02ed-57e9-1500-e054-00144ff88e88 59535-0223 HUMAN OTC DRUG PROPOLIS 50 VOLUME MIST PROPOLIS WAX, NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20160901 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. PROPOLIS WAX; NIACINAMIDE; ADENOSINE 50; 2; .04 g/100mL; g/100mL; g/100mL N 20181231 59535-0224_3b6bb0ca-70d5-49b5-e054-00144ff88e88 59535-0224 HUMAN OTC DRUG GALACTOMYCES RADIANCE TONER NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20160901 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0225_3e146327-09ef-1fe2-e054-00144ff8d46c 59535-0225 HUMAN OTC DRUG GALACTOMYCES 80 Contouring EYE NIACINAMIDE, ADENOSINE CREAM TOPICAL 20160901 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 mg/100mL; mg/100mL N 20181231 59535-0226_3b6bb0ca-70df-49b5-e054-00144ff88e88 59535-0226 HUMAN OTC DRUG GALACTOMYCES 90 AMPOULE NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20160901 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0227_3b6bb0ca-70eb-49b5-e054-00144ff88e88 59535-0227 HUMAN OTC DRUG GALACTOMYCES 70 NIACINAMIDE, ADENOSINE CREAM TOPICAL 20160901 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0228_3d77ef0d-ab14-4a97-e054-00144ff8d46c 59535-0228 HUMAN OTC DRUG GALACTOMYCES FIRST ESSENCE NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20160927 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0229_50dde67f-8c0d-1975-e054-00144ff88e88 59535-0229 HUMAN OTC DRUG GINSENG BERRY EYE LIFT GLYCERIN PATCH TOPICAL 20160901 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. GLYCERIN 70.4 mg/1 N 20181231 59535-0230_3d778cd9-7643-54df-e054-00144ff88e88 59535-0230 HUMAN OTC DRUG GINSENG BERRY 80 EYE ESSENCE NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20160927 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0231_3b3f9b00-3d41-2406-e054-00144ff88e88 59535-0231 HUMAN OTC DRUG Volcanic Pore Cleansing Patch Hamamelis Virginiana (Witch Hazel) Extract PATCH TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. WITCH HAZEL .01 g/100g N 20181231 59535-0232_3b43c6cd-2422-359f-e054-00144ff88e88 59535-0232 HUMAN OTC DRUG Volcanic Pore Eraser Ampoule Adenosine, Niacinamide LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0233_3b43fc97-9215-3448-e054-00144ff8d46c 59535-0233 HUMAN OTC DRUG Volcanic Pore Heating Gel Volcanic Ash, Glycerin GEL TOPICAL 20160801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 91.16098 g/100g N 20181231 59535-0234_3aef600b-3916-3bef-e054-00144ff8d46c 59535-0234 HUMAN OTC DRUG Galactomyces and Rice Callus Mask Adenosine, Niacinamide LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100g; g/100g N 20181231 59535-0235_3af13426-4e23-2fb0-e054-00144ff8d46c 59535-0235 HUMAN OTC DRUG Propolis and Rose Callus Mask Adenosine, Niacinamide LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100g; g/100g N 20181231 59535-0236_3d8acbbb-6a10-3937-e054-00144ff8d46c 59535-0236 HUMAN OTC DRUG Centella and Green Tea Callus Mask Niacinamide, Adenosine LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100g; g/100g N 20181231 59535-0237_3af15cce-777c-35b3-e054-00144ff8d46c 59535-0237 HUMAN OTC DRUG Ginseng Berry and Ginseng Callus Mask Adenosine, Niacinamide LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100g; g/100g N 20181231 59535-0238_3b69b9f1-19ca-56f8-e054-00144ff8d46c 59535-0238 HUMAN OTC DRUG Volcanic Grape Callus Mask Adenosine, Niacinamide LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100g; g/100g N 20181231 59535-0239_3b69f8c2-5307-2ae2-e054-00144ff8d46c 59535-0239 HUMAN OTC DRUG Propolis 27 Cover Cushion TITANIUM DIOXIDE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, NIACINAMIDE, Octocrylene, ZINC OXIDE, ADENOSINE LIQUID TOPICAL 20150705 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE; NIACINAMIDE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; OCTOCRYLENE; ZINC OXIDE .00385; 2; 7; 4.8; 13.9936; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59535-0240_3daf8d9c-f338-6853-e054-00144ff8d46c 59535-0240 HUMAN OTC DRUG Tangerine Bright Sleeping Mask Niacinamide, Adenosine LIQUID TOPICAL 20160223 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE; NIACINAMIDE .04; 2 g/100g; g/100g N 20181231 59535-0241_3db03ca6-7220-4139-e054-00144ff88e88 59535-0241 HUMAN OTC DRUG Camellia Calming Sleeping Mask Niacinamide, Adenosine LIQUID TOPICAL 20160223 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE; NIACINAMIDE .04; 2 g/100g; g/100g N 20181231 59535-0242_3b6bb0ca-70bc-49b5-e054-00144ff88e88 59535-0242 HUMAN OTC DRUG Volcanic Pore Tightening Mask GLYCERIN CREAM TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g N 20181231 59535-0243_4feaf98e-a262-4eb1-e054-00144ff8d46c 59535-0243 HUMAN OTC DRUG Volcanic Homme Foam Cleanser Volcanic Ash, Glycerin CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 10 g/100mL N 20181231 59535-0244_4feaf98e-a26b-4eb1-e054-00144ff8d46c 59535-0244 HUMAN OTC DRUG Volcanic Homme Toner Adenosine, Niacinamide LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0245_4feaf98e-a274-4eb1-e054-00144ff8d46c 59535-0245 HUMAN OTC DRUG Volcanic Homme Adenosine, Niacinamide EMULSION TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0246_4feaf98e-a27d-4eb1-e054-00144ff8d46c 59535-0246 HUMAN OTC DRUG Volcanic Homme All in One Essence Adenosine, Niacinamide LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0247_3be1a474-675f-53fe-e054-00144ff88e88 59535-0247 HUMAN OTC DRUG Rose Oasis 80 Ampoule Adenosine, Niacinamide LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .044 g/100mL; g/100mL N 20181231 59535-0248_3be1516f-51ae-4997-e054-00144ff88e88 59535-0248 HUMAN OTC DRUG Rose Oasis 70 Cream Adenosine, Niacinamide CREAM TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0249_4feaf98e-a259-4eb1-e054-00144ff8d46c 59535-0249 HUMAN OTC DRUG Rose Oasis 50 Moisture Bomb Adenosine, Niacinamide CREAM TOPICAL 20160801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0251_3db1ad4d-63c8-06be-e054-00144ff88e88 59535-0251 HUMAN OTC DRUG Propolis 20 BB Cream Ethylhexyl Methoxycinnamate, Titanium Dioxide, Arbutin, Adenosine, Ethylhexyl Salicylate CREAM TOPICAL 20160223 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. OCTISALATE; ARBUTIN; ADENOSINE; OCTINOXATE; TITANIUM DIOXIDE 2; 2; .04; 5; 9.34 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59535-0252_3db2ebd2-2e8d-1776-e054-00144ff8d46c 59535-0252 HUMAN OTC DRUG Volcanic Pore Refining Mask Glycerin CREAM TOPICAL 20160223 OTC MONOGRAPH NOT FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 10 g/100mL N 20181231 59535-0253_3db335fa-fdf8-3bf2-e054-00144ff88e88 59535-0253 HUMAN OTC DRUG GINSENG BERRY 80 OVERNIGHT MASK NIACINAMIDE, ADENOSINE CREAM TOPICAL 20160928 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100g; g/100g N 20181231 59535-0254_3d867b08-514e-47e9-e054-00144ff8d46c 59535-0254 HUMAN OTC DRUG GREEN PROPOLIS 90 AMPOULE NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20160928 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 59535-0255_454fc110-9e03-7393-e054-00144ff88e88 59535-0255 HUMAN OTC DRUG DCS MERDERM JEJU LAVA SEAWATER TONER Adenosine LIQUID TOPICAL 20161201 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 59535-0256_456485bc-bf80-4bc2-e054-00144ff88e88 59535-0256 HUMAN OTC DRUG DCS MERDERM JEJU LAVA SEAWATER AMPOULE Adenosine LIQUID TOPICAL 20161201 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 59535-0257_4565f87e-526b-1a3c-e054-00144ff88e88 59535-0257 HUMAN OTC DRUG DCS MERDERM JEJU LAVA SEAWATER Adenosine CREAM TOPICAL 20161201 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 59535-0258_456574d8-8823-4bed-e054-00144ff8d46c 59535-0258 HUMAN OTC DRUG DCS MERDERM JEJU LAVA SEAWATER EYE Adenosine CREAM TOPICAL 20170106 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 59535-0259_4565f87e-525d-1a3c-e054-00144ff88e88 59535-0259 HUMAN OTC DRUG DCS MERDERM JEJU LAVA SEAWATER CLEANSING FOAM Glycerin CREAM TOPICAL 20170106 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. GLYCERIN 10.0002 g/100mL N 20181231 59535-0260_4b37240b-5fc3-086f-e054-00144ff8d46c 59535-0260 HUMAN OTC DRUG JEJUEN Hyaluron Waterful Extreme Micro Silky Mask Adenosine LIQUID TOPICAL 20170301 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 59535-0261_4b36c2e7-5932-2b74-e054-00144ff88e88 59535-0261 HUMAN OTC DRUG JEJUEN Rape Flower Shining Extreme Micro Silky Mask Adenosine LIQUID TOPICAL 20170301 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 59535-0262_4b360d5d-0376-161b-e054-00144ff88e88 59535-0262 HUMAN OTC DRUG JEJUEN Volcanic Pore Zero Extreme Micro Silky Mask Adenosine LIQUID TOPICAL 20170301 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 59535-0263_4b360d5d-0357-161b-e054-00144ff88e88 59535-0263 HUMAN OTC DRUG JEJUEN Camellia Wrinkle Care Extreme Micro Silky Mask Adenosine LIQUID TOPICAL 20170321 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 59535-0264_4b36c2e7-594b-2b74-e054-00144ff88e88 59535-0264 HUMAN OTC DRUG JEJUEN Aloe Soothing Extreme Micro Silky Mask Adenosine LIQUID TOPICAL 20170321 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 59535-0265_4b338dc0-108b-3c18-e054-00144ff88e88 59535-0265 HUMAN OTC DRUG JEJUEN BLACK BEAN FERMENT TONER Adenosine LIQUID TOPICAL 20170316 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 59535-0266_4b37240b-5fd8-086f-e054-00144ff8d46c 59535-0266 HUMAN OTC DRUG JEJUEN BLACK BEAN FERMENT Adenosine CREAM TOPICAL 20170316 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 59535-0267_4b33c764-388e-5555-e054-00144ff8d46c 59535-0267 HUMAN OTC DRUG JEJUEN BLACK BEAN FERMENT Adenosine EMULSION TOPICAL 20170316 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 59535-0269_5fa65b22-6fee-28f6-e053-2a91aa0a9eec 59535-0269 HUMAN OTC DRUG BRIGHT EYE VITALIZER dimthicone CREAM TOPICAL 20171207 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. DIMETHICONE 1 g/100mL N 20181231 59535-0270_5fbd4b53-61da-0c14-e053-2a91aa0aeee8 59535-0270 HUMAN OTC DRUG V10 MULTI-LIFT SLEEPING PACK allantoin CREAM TOPICAL 20171207 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .1 g/100mL N 20181231 59535-0301_56cc5a0a-812d-4897-ad87-5b2e53843733 59535-0301 HUMAN OTC DRUG COLLAGEN RESURGENCE STEMCELL BB ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .0686 mg/g E 20171231 59535-0401_4f80042c-6dcd-4750-a39a-35c0f8fd9fe2 59535-0401 HUMAN OTC DRUG MAX HYALURONIC STEMCELL SLEEPING PACK GLYCERIN CREAM TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .02 g/mL E 20171231 59535-0601_e173b195-9d36-432a-ac26-482e8714f34c 59535-0601 HUMAN OTC DRUG Vitalizer Laser Aid BB Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/g E 20171231 59535-0701_13b3cdf9-1da0-4559-95c9-3710c582e750 59535-0701 HUMAN OTC DRUG Blemish Toner Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .02 g/mL E 20171231 59535-0801_dcd8acb4-7d7e-42a8-8031-0ab055cbb795 59535-0801 HUMAN OTC DRUG Jasmine Eco Mist Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .01 g/mL E 20171231 59535-0901_0c2ead9e-dffc-449a-9fb5-ec7b1a1135cd 59535-0901 HUMAN OTC DRUG Pore Tightening Serum Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL E 20171231 59535-1001_32549d52-3497-4283-82b2-77f4d7646f1a 59535-1001 HUMAN OTC DRUG GOLD CAVIAR BB Zinc oxide CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .07 g/g E 20171231 59535-1011_4f2ef720-be2b-4f6e-abc2-4dfd6d2192d9 59535-1011 HUMAN OTC DRUG Super Aqua Toner Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL E 20171231 59535-1021_6b11430e-8f06-485a-a1ef-38f5e7c7e8a5 59535-1021 HUMAN OTC DRUG Super Aqua Ampoule Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/mL E 20171231 59535-1031_21e976f5-0d89-41d0-87b1-7980acb81f03 59535-1031 HUMAN OTC DRUG Super Aqua Day Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL E 20171231 59535-1041_0db2990d-545c-4d8e-9911-592a0d4f25d3 59535-1041 HUMAN OTC DRUG Super Aqua Night Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/mL E 20171231 59535-1051_c1c7abf0-b87d-46a7-86bb-0e4025911c59 59535-1051 HUMAN OTC DRUG Super Aqua Eye Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/mL E 20171231 59535-1061_5336e37e-706c-706a-e054-00144ff88e88 59535-1061 HUMAN OTC DRUG DCS Super Aqua Mask Adenosine EMULSION TOPICAL 20170316 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100g N 20181231 59535-1071_2a50c24e-1a3d-4f00-9259-9693b1b8acdb 59535-1071 HUMAN OTC DRUG Ultra Nutrition Toner Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/mL E 20171231 59535-1081_8277aa7d-adee-493f-b895-3270f8dcff12 59535-1081 HUMAN OTC DRUG Ultra Nutrition Ampoule Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL E 20171231 59535-1091_b7d99f12-5848-42bb-b272-4d23bb633a0a 59535-1091 HUMAN OTC DRUG Ultra Nutrition Day Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL E 20171231 59535-1101_06f774af-85e5-4195-9db2-2e14eca8eb35 59535-1101 HUMAN OTC DRUG Medskin Cleansing POLYSORBATE 20 OIL TOPICAL 20130801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. POLYSORBATE 20 .21 mg/mL E 20171231 59535-1111_d45266ad-86ce-4fd9-b1bd-6260d794b591 59535-1111 HUMAN OTC DRUG Ultra Nutrition Eye Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/mL E 20171231 59535-1121_533ee72a-94b5-616b-e054-00144ff8d46c 59535-1121 HUMAN OTC DRUG DCS Ultra Nutrition Mask Adenosine LIQUID TOPICAL 20170316 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. ADENOSINE .04 g/100g N 20181231 59535-1131_1ffba80e-2be0-4d95-b83f-8282256f80e5 59535-1131 HUMAN OTC DRUG Intensive Vital Ampoule Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .02 g/mL E 20171231 59535-1141_3e3e1e83-00ab-0ec5-e054-00144ff88e88 59535-1141 HUMAN OTC DRUG BRTC ANTI BLEMISH COMPLEX Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1151_26e23ee2-4aaa-4841-95ea-0288e82184d7 59535-1151 HUMAN OTC DRUG BRTC BLUE PHYTO COMPLEX Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1161_3e3f381e-3e22-09a8-e054-00144ff8d46c 59535-1161 HUMAN OTC DRUG BRTC PURPLE VIGOR COMPLEX Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1171_db439fd0-adb8-4552-9e71-4ba3a9d33f54 59535-1171 HUMAN OTC DRUG BRTC TANNIN PORE COMPLEX Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1181_6915bdc5-226c-457f-91a5-b3a3eaa481ff 59535-1181 HUMAN OTC DRUG BRTC WHITE PHYTO COMPLEX Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1191_3e3e1e83-00bf-0ec5-e054-00144ff88e88 59535-1191 HUMAN OTC DRUG CLIV RYEOYUN SNOW WHITE AMPOULE Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1201_66aacc1f-141e-478f-9dd7-001b935cb38b 59535-1201 HUMAN OTC DRUG ULTRA HYDRO FACIAL FOAM GLYCERIN LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .015 g/mL E 20171231 59535-1211_bfa71a97-55fd-4aee-bce6-7532730c0391 59535-1211 HUMAN OTC DRUG CLIV RYEOYUN SNOW WHITE Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1221_ca7f6e30-33d2-4423-93d0-269310a47ab4 59535-1221 HUMAN OTC DRUG JEJUEN LIGHTENING BLUEBERRY ICE MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3 g/100g N 20181231 59535-1231_3e3f79df-7291-59e7-e054-00144ff8d46c 59535-1231 HUMAN OTC DRUG JEJUEN CALMING ALOE ICE PACK Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1241_cee5bcfe-54a7-4a1b-8e5b-7d1b1bb7a7d1 59535-1241 HUMAN OTC DRUG JEJUEN CALMING ALOE SHEET MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g N 20181231 59535-1251_7535ce13-cc37-4d4f-80be-b20a4e73109c 59535-1251 HUMAN OTC DRUG JEJUEN CALMING BROCCOLI ICE MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3 g/100g N 20181231 59535-1261_3e401dd9-d414-4c16-e054-00144ff88e88 59535-1261 HUMAN OTC DRUG JEJUEN LIGHTENING HANRABONG ICE PACK Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1271_ea93876f-9088-4e6d-8f06-64ec9811728a 59535-1271 HUMAN OTC DRUG JEJUEN LIGHTENING HANRABONG SHEET MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g N 20181231 59535-1281_320396e0-cf7f-411e-b900-988bb9657870 59535-1281 HUMAN OTC DRUG JEJUEN NO SEBUM LOTUS ICE MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3 g/100g N 20181231 59535-1291_9ae69d22-fcb2-479a-b740-b14baebe2aa6 59535-1291 HUMAN OTC DRUG JEJUEN NOURISHING BEET ICE MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3 g/100g N 20181231 59535-1301_7ca5b273-2407-4689-bb7e-fb4f1a696944 59535-1301 HUMAN OTC DRUG REVITALIZING FACIAL FOAM GLYCERIN LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .015 g/mL E 20171231 59535-1311_7ebee479-5283-4c87-989f-9387a093d1fa 59535-1311 HUMAN OTC DRUG JEJUEN NOURISHING OPUNTIA SHEET MASK Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g N 20181231 59535-1321_3e3f79df-729e-59e7-e054-00144ff8d46c 59535-1321 HUMAN OTC DRUG JEJUEN PORE TIGHTENING PEPPERMINT ICE PACK Glycerin CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1331_8c093dfb-83af-4a45-be26-84d7c4f5bca3 59535-1331 HUMAN OTC DRUG JEJUEN PORE TIGHTENING PEPPERMINT SHEET MASK Glycerin LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g N 20181231 59535-1341_3e405a01-37b6-5af3-e054-00144ff88e88 59535-1341 HUMAN OTC DRUG JEJUEN WATERFUL APPLEMANGO ICE PACK Glycerin CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1351_76497a5e-bddf-4f2a-9613-a4f769d48e0c 59535-1351 HUMAN OTC DRUG JEJUEN WATERFUL APPLEMANGO SHEET MASK Glycerin LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g N 20181231 59535-1361_da9c6da8-a05a-4457-8019-daf9dcfdd27a 59535-1361 HUMAN OTC DRUG JEJUEN WATERFUL PEANUT ICE MASK Glycerin LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g N 20181231 59535-1371_50dde67f-8c17-1975-e054-00144ff88e88 59535-1371 HUMAN OTC DRUG BRTC VITALIZER SLEEPING PACK Glycerin CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 8 g/100mL N 20181231 59535-1381_50e02dc3-f723-053d-e054-00144ff8d46c 59535-1381 HUMAN OTC DRUG DCS PORE REFINING Glycerin CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 1 g/100mL N 20181231 59535-1391_01817052-81ab-437e-85ad-b88d5dff6b2a 59535-1391 HUMAN OTC DRUG DSC PORE CLEANSING Glycerin PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 1 g/100g N 20181231 59535-1401_eb15dca5-3cfd-4e9f-9085-b7b089bbd017 59535-1401 HUMAN OTC DRUG WHITENING LEMON PEEL CITRIC ACID MONOHYDRATE LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part331 AMI Cosmetic Co.,Ltd. CITRIC ACID MONOHYDRATE .007 g/mL E 20171231 59535-1411_caf12112-3017-4f2c-9496-3566f8e053c0 59535-1411 HUMAN OTC DRUG DCS PORE HEATING CLEANSING Glycerin GEL TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 91.16098 g/100mL N 20181231 59535-1421_65cbad17-afd4-40a4-a81f-8a1beffd611d 59535-1421 HUMAN OTC DRUG DCS BLEMISH CARE FOAM CLEANSER Glycerin LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 20.009 g/100mL N 20181231 59535-1431_cdb807f0-2c66-443b-b7bd-3195b77e4f66 59535-1431 HUMAN OTC DRUG DCS BLEMISH CARE Glycerin CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 15.585 g/100mL N 20181231 59535-1441_a633a6a4-dddd-4d0d-b8ed-53a675458146 59535-1441 HUMAN OTC DRUG DCS BLEMISH CARE AMPOULE Glycerin LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 11.3 g/100mL N 20181231 59535-1451_67d27474-b194-4d83-a2d7-d1631b5611fa 59535-1451 HUMAN OTC DRUG DCS INTENSIVE VITAL MASK Glycerin LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100g N 20181231 59535-1461_e50d353d-2a90-471e-8cd7-c26764d52058 59535-1461 HUMAN OTC DRUG DCS INTENSIVE VITAL Glycerin CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 11.0005 g/100mL N 20181231 59535-1471_a375f4b4-9fd8-429f-97fa-ca43ce65bd08 59535-1471 HUMAN OTC DRUG DCS INTENSIVE VITAL TONER Glycerin LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 10.05 g/100mL N 20181231 59535-1481_23b201bb-badd-4b24-be01-9bc0dec2d850 59535-1481 HUMAN OTC DRUG JEJUEN LOTUS BUBBLE FOAM CLEANSER Glycerin LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1491_eec4260b-9775-42b4-a162-acb7c38280ab 59535-1491 HUMAN OTC DRUG JEJUEN PLACENTA BOOSTING AMPOULE DIMETHICONE LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. DIMETHICONE 1.5 g/100mL N 20181231 59535-1501_69b75e1d-1774-4a60-a3c7-99c02efbd431 59535-1501 HUMAN OTC DRUG HERBAL STEMCELL AHA PEEL LACTIC ACID LIQUID TOPICAL 20130801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. LACTIC ACID .01 mg/mL E 20171231 59535-1511_f65a60af-5765-4a23-aed3-6e40d3b81802 59535-1511 HUMAN OTC DRUG BRTC Animal Horse GLYCERIN LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4 g/100g N 20181231 59535-1521_3c86be38-0bf7-48d1-948c-77eb9cb4c274 59535-1521 HUMAN OTC DRUG BRTC Animal Mask Shark GLYCERIN LIQUID TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4 g/100g N 20181231 59535-1531_0f220ff8-6128-40f0-8e25-d81881293842 59535-1531 HUMAN OTC DRUG BRTC Animal Msk Sheep GLYCERIN LIQUID TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4 g/100g N 20181231 59535-1541_264bbe2a-aee1-42d4-a980-8f4dad83b666 59535-1541 HUMAN OTC DRUG BRTC Animal Mask Swallow GLYCERIN LIQUID TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4 g/100g N 20181231 59535-1551_3e81a44d-3c60-6476-e054-00144ff8d46c 59535-1551 HUMAN OTC DRUG CLIV Character Mask Bee GLYCERIN LIQUID TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4 g/100g N 20181231 59535-1561_27681389-1f01-4362-9b54-cae156c627d5 59535-1561 HUMAN OTC DRUG CLIV Character Mask Panda GLYCERIN LIQUID TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4 g/100g N 20181231 59535-1571_f6b98634-3a3b-45db-97a4-3803462725eb 59535-1571 HUMAN OTC DRUG CLIV Character Mask Penguin GLYCERIN LIQUID TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4 g/100g N 20181231 59535-1581_a9c5eb89-147c-4c9e-80d1-b53749eb1a35 59535-1581 HUMAN OTC DRUG CLIV Character Mask Tiger GLYCERIN LIQUID TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4 g/100g N 20181231 59535-1591_3e8158e9-a020-2c6a-e054-00144ff88e88 59535-1591 HUMAN OTC DRUG BRTC Make Over Mask Bewitch GLYCERIN LIQUID TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4 g/100g N 20181231 59535-1601_28cccdf1-0d40-48fc-9f50-28681ca00d20 59535-1601 HUMAN OTC DRUG ACTIVE RESURGENCE TONER GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 mg/mL E 20171231 59535-1611_3e81a44d-3c6c-6476-e054-00144ff8d46c 59535-1611 HUMAN OTC DRUG BRTC Make Over Mask Temptation GLYCERIN LIQUID TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4 g/100g N 20181231 59535-1621_3e821204-d4d0-056c-e054-00144ff8d46c 59535-1621 HUMAN OTC DRUG BRTC Make Over Mask Purity GLYCERIN LIQUID TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 4 g/100g N 20181231 59535-1631_62fe2fbb-e879-4c25-9dbe-5d1702b0cafb 59535-1631 HUMAN OTC DRUG BRTC Bright Eye Vitalizer GLYCERIN CREAM TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 2 g/100g N 20181231 59535-1641_3e81a44d-3ca7-6476-e054-00144ff8d46c 59535-1641 HUMAN OTC DRUG essenHERB Tea Tree 90 Calming Toner GLYCERIN LIQUID TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .935 g/100mL N 20181231 59535-1651_3e821204-d4dc-056c-e054-00144ff8d46c 59535-1651 HUMAN OTC DRUG essenHerb Rice Bran 90 Cleansing RICE BRAN OIL TOPICAL 20150611 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. RICE BRAN OIL 91.22 g/100mL N 20181231 59535-1661_3e82bf35-1e19-59fa-e054-00144ff88e88 59535-1661 HUMAN OTC DRUG essenHERB Soybean 90 Deep Cleansing RICE BRAN OIL TOPICAL 20150611 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. SOYBEAN OIL 91.6 g/100mL N 20181231 59535-1671_2224b312-477a-4966-98cd-49bcf05a0c18 59535-1671 HUMAN OTC DRUG BRTC Jasmine 3D Jelly Foundation GLYCERIN POWDER TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 1.8 g/100mL N 20181231 59535-1681_3e821204-d4ea-056c-e054-00144ff8d46c 59535-1681 HUMAN OTC DRUG essenHERB Tea Tree 70 Sleeping Pack GLYCERIN CREAM TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5 g/100mL N 20181231 59535-1691_3e82bf35-1e23-59fa-e054-00144ff88e88 59535-1691 HUMAN OTC DRUG PureHeals Propolis 80 GLYCERIN CREAM TOPICAL 20150610 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 1.2 g/100mL N 20181231 59535-1701_9dfd3690-d585-4654-858d-1aeffe5d1550 59535-1701 HUMAN OTC DRUG ULTRA HYDRA TONER GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .02 mg/mL E 20171231 59535-1711_2c7de121-18db-199f-e054-00144ff88e88 59535-1711 HUMAN OTC DRUG JEJUEN CAMELLIA NOURISHING PACK GLYCERIN LIQUID TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3.2 g/100mL N 20181231 59535-1721_2c7de121-18e5-199f-e054-00144ff88e88 59535-1721 HUMAN OTC DRUG JEJUEN ALOE SLEEPING PACK GLYCERIN GEL TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5.5 g/100mL N 20181231 59535-1731_2c7de121-18f0-199f-e054-00144ff88e88 59535-1731 HUMAN OTC DRUG JEJUEN RAPEFLOWER PACK GLYCERIN LIQUID TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3.02 g/100mL N 20181231 59535-1741_2c7de121-18fa-199f-e054-00144ff88e88 59535-1741 HUMAN OTC DRUG JEJUEN VOLCANIC AMPOULE SLEEPING PACK GLYCERIN LIQUID TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 5.5 g/100mL N 20181231 59535-1751_2c7da071-2029-3d42-e054-00144ff8d46c 59535-1751 HUMAN OTC DRUG JEJUEN HYALURON SLEEPING PACK GLYCERIN LIQUID TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN 3.02 g/100mL N 20181231 59535-1761_3e82bf35-1e2d-59fa-e054-00144ff88e88 59535-1761 HUMAN OTC DRUG BRTC VITALIZER C10 AMPOULE ALLANTOIN LIQUID TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .15 g/100mL N 20181231 59535-1771_2c7da071-203d-3d42-e054-00144ff8d46c 59535-1771 HUMAN OTC DRUG BRTC OVERNIGHT PORE TIGHTENER GLYCERIN CREAM TOPICAL 20160223 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .15 g/100mL N 20181231 59535-1801_96923229-dc8e-4a76-a77d-fbaa303c2055 59535-1801 HUMAN OTC DRUG REVITALIZING C TONER GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 mg/mL E 20171231 59535-1901_8390faca-3bcf-448c-bbad-c39f75bed013 59535-1901 HUMAN OTC DRUG ACTIVE RESURGENCE EYE GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .07 mg/mL E 20171231 59535-2001_1540b958-4006-4529-a4cd-03445faf75fb 59535-2001 HUMAN OTC DRUG JASMINE WATER BB Zinc oxide CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .0192 g/g E 20171231 59535-2101_13944a2f-9cee-46f7-b103-63233db871f6 59535-2101 HUMAN OTC DRUG ULTRA HYDRA SERUM GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .1 g/mL E 20171231 59535-2201_89b25740-e113-48d4-a35b-c1c0e43b5737 59535-2201 HUMAN OTC DRUG REVITALIZING C SERUM GLYCERIN LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL E 20171231 59535-2301_537bec62-fa94-4191-80bb-cf371d9dacfd 59535-2301 HUMAN OTC DRUG COLLAGEN RESURGENCE LASER AMPOULE GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 mg/mL E 20171231 59535-2401_ff9337dc-e6f1-4c02-88cd-794ce57afb58 59535-2401 HUMAN OTC DRUG REVITALIZING C I2PL CORRECTOR AMPOULE GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 mg/mL E 20171231 59535-2501_c5518bfa-5f70-474d-a72d-ba8018fe6901 59535-2501 HUMAN OTC DRUG SEAWEED MEDICLEAR HEALER AMPOULE GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .018 mg/mL E 20171231 59535-2601_6cf48362-1a3d-4335-b49b-795a9a9a19b6 59535-2601 HUMAN OTC DRUG ACTIVE RESURGENCE GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/g E 20171231 59535-2701_d1c8cb89-1dd6-40d0-87d1-cb94d0496ad3 59535-2701 HUMAN OTC DRUG ULTRA HYDRA GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .1 g/g E 20171231 59535-2801_500ac9c3-f77b-4ac8-be85-2e9663cfde2e 59535-2801 HUMAN OTC DRUG REVITALIZING C GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .1 g/g E 20171231 59535-2901_51c6a2e4-fbf3-4df7-ac2c-f79c3a2de6e8 59535-2901 HUMAN OTC DRUG MAX HYALURONIC UV STEMCELL SUN BLOCK GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .00001 mg/mL E 20171231 59535-3001_40541278-8e3c-4e97-94fb-c9010077ddb2 59535-3001 HUMAN OTC DRUG JASMINE 3D WATERFUL 3D C.C Zinc oxide CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .07 g/g E 20171231 59535-3011_bdb98f1e-ce10-46e0-913c-7c7b67e4ef7a 59535-3011 HUMAN OTC DRUG JASMINE 3D WATERFUL CC Zinc oxide CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .07 g/g E 20171231 59535-3101_ca38b6a4-a0b0-4f87-9f7a-e09e1259cc12 59535-3101 HUMAN OTC DRUG REVITALIZING C I2PL STEMCELL BB ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .0686 mg/g E 20171231 59535-3201_71357bb9-1b25-4997-a03d-1b8aa8e58ea1 59535-3201 HUMAN OTC DRUG SEAWEED MEDICLEAR STEMCELL BB GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .000001 g/g E 20171231 59535-3301_6bf0a4f6-fdd4-4a63-b7a4-48d834bcab01 59535-3301 HUMAN OTC DRUG MEDICLEAR DUAL SPOT DAY and NIGHT GLYCERIN LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL E 20171231 59535-3311_a05fbb7b-4963-4f16-a506-6315b217e01a 59535-3311 HUMAN OTC DRUG MEDICLEAR DUAL SPOT DAY and NIGHT GLYCERIN LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL E 20171231 59535-3401_60b2b1ae-3f80-4b4f-b492-d62ce529bca9 59535-3401 HUMAN OTC DRUG GOLDEN BALL HEALER GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 mg/mL E 20171231 59535-3501_224efa75-6c0e-45c9-8d99-607c4e0cd8e6 59535-3501 HUMAN OTC DRUG SNAIL RECOVER HEALER GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .07 mg/mL E 20171231 59535-3601_c80cf794-b449-4bff-8071-4e950b7aefaf 59535-3601 HUMAN OTC DRUG BLACK HEAD REMOVER PANTHENOL LIQUID TOPICAL 20130801 UNAPPROVED DRUG OTHER AMI Cosmetic Co.,Ltd. PANTHENOL .002 mg/mL E 20171231 59535-3701_4d4f182f-20f4-4088-a0fd-bd4cf46c96c2 59535-3701 HUMAN OTC DRUG MULTI ACTION POWER GLYCERIN EMULSION TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .075205 g/mL E 20171231 59535-3801_87e3c031-0437-4256-8fef-b174a4ce15c5 59535-3801 HUMAN OTC DRUG MULTI ACTION BALANCING TONER GLYCERIN LIQUID TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05205 g/mL E 20171231 59535-3901_e511ca99-7f90-4499-a136-ff4d10bc31a8 59535-3901 HUMAN OTC DRUG MAX HYALURONIC STEMCELL EYE GLYCERIN CREAM TOPICAL 20130831 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .00007 g/mL E 20171231 59535-4001_d2d214ae-8940-420a-884b-e0da0cd54a83 59535-4001 HUMAN OTC DRUG BRIGHT EYE VITALIZER DIMETHICONE STICK TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. DIMETHICONE .01 g/g E 20171231 59535-4101_1703580f-3cdf-46f5-b3a3-b8a452926ddc 59535-4101 HUMAN OTC DRUG SUPREME 1ST ESSENCE ALLANTOIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .002 mg/mL E 20171231 59535-4201_cdfec46a-5e01-4b98-aa45-ab18906455a3 59535-4201 HUMAN OTC DRUG V SHAPING AMPOULE GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .01 mg/mL E 20171231 59535-4301_c073b801-9a36-4131-aac7-fd66efb52e8d 59535-4301 HUMAN OTC DRUG COLLAGEN RESURGENCE MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .01 g/g E 20171231 59535-4311_3da48f12-bf12-4461-a34d-c58f477070ca 59535-4311 HUMAN OTC DRUG COLLAGEN RESURGENCE MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/g E 20171231 59535-4401_cdc5f742-16f9-4f70-9d24-7d853d163c9b 59535-4401 HUMAN OTC DRUG MAX HYALURONIC MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .01 g/g E 20171231 59535-4411_00de3be6-69d4-4be6-99cb-58958c31394a 59535-4411 HUMAN OTC DRUG MAX HYALURONIC MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/g E 20171231 59535-4501_faf9d1ca-33e6-4268-8f19-2330878b2cd0 59535-4501 HUMAN OTC DRUG REVITALIZING C I2PL MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .01 g/g E 20171231 59535-4511_9f20ca0f-ec1e-4b65-84b8-fffe2b9306c7 59535-4511 HUMAN OTC DRUG REVITALIZING C I2PL MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .100005 g/g E 20171231 59535-4601_2204cb8d-26e2-4c96-acef-cb10f34b9394 59535-4601 HUMAN OTC DRUG SEAWEED MEDICLEAR MASK GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .01 g/g E 20171231 59535-4611_c32865db-3423-4f66-8cf1-7a9ab5919af5 59535-4611 HUMAN OTC DRUG SEAWEED MEDICLEAR MASK GLYCERIN LIQUID TOPICAL 20130907 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/g E 20171231 59535-4701_f3890438-e7c6-41a4-9c0a-9e2c92d355ac 59535-4701 HUMAN OTC DRUG CLIV Barrier Power Ampoule GLYCERIN LIQUID TOPICAL 20140306 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/mL E 20171231 59535-4801_4f0fe89b-472d-40ba-acdb-de27b38f6481 59535-4801 HUMAN OTC DRUG CLIV Barrier Power GLYCERIN CREAM TOPICAL 20140306 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/mL E 20171231 59535-4911_1467507a-ee16-4445-bca1-be201c16ee0f 59535-4911 HUMAN OTC DRUG CLIV Barrier Power GLYCERIN LOTION TOPICAL 20140306 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .09 g/mL E 20171231 59535-5001_0496befb-f2f0-431f-b915-6f40142eb96e 59535-5001 HUMAN OTC DRUG OVERNIGHT PORE TIGHTENER DIMETHICONE GEL TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. DIMETHICONE .024 g/mL E 20171231 59535-5011_350f0e3f-0393-406b-b5fe-014c5a90799c 59535-5011 HUMAN OTC DRUG CLIV Ginseng Berry Premium Ampoule GLYCERIN LIQUID TOPICAL 20140306 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/mL E 20171231 59535-5101_52cce31a-67b2-46f0-87d4-ad5d4ab6069d 59535-5101 HUMAN OTC DRUG CLIV Ginseng Berry Premium GLYCERIN CREAM TOPICAL 20140306 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .0433 g/mL E 20171231 59535-5201_42db4e22-f8e5-49d8-b9df-e8f9a1ae284d 59535-5201 HUMAN OTC DRUG CLIV Ginseng Berry Premium Eye GLYCERIN CREAM TOPICAL 20140306 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .0279 g/mL E 20171231 59535-5301_d47da0f2-c454-4f74-a2e2-8b6ce08f19ff 59535-5301 HUMAN OTC DRUG Gold Caviar Cover Cushion Zinc oxide POWDER TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .02 g/g E 20171231 59535-5401_2b10274c-4ab0-4a44-94f8-800fb1e3cb7c 59535-5401 HUMAN OTC DRUG The First Ampoule Essence Allantoin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .002 g/g E 20171231 59535-5501_ed60a2e8-3521-497a-9a33-edcea860eb80 59535-5501 HUMAN OTC DRUG The First Ampoule Essence BB Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/g E 20171231 59535-5601_50e012d5-dfd9-330f-e054-00144ff88e88 59535-5601 HUMAN OTC DRUG Medi Stem Eye Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .10295 g/mL N 20181231 59535-5701_f4d29336-91b8-46fe-b46c-b82091c1feeb 59535-5701 HUMAN OTC DRUG Medi Stem Collagen Ampoule Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL E 20171231 59535-5801_c42f8a05-65cf-4780-8f0e-c40f8d871671 59535-5801 HUMAN OTC DRUG Medi Stem Collagen Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .02 g/mL E 20171231 59535-5901_50e02dc3-f719-053d-e054-00144ff8d46c 59535-5901 HUMAN OTC DRUG Medi Stem Collagen Toner Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/mL N 20181231 59535-6001_20e6064d-ddb9-484e-8303-ae1e6b2e1ce8 59535-6001 HUMAN OTC DRUG BLEMISH RECOVER BALM DIMETHICONE CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. DIMETHICONE .015 g/mL E 20171231 59535-6101_e36dcec6-e421-48ce-bf35-f3251767f85d 59535-6101 HUMAN OTC DRUG Vitalizer Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL E 20171231 59535-6201_4440f8d5-e9f4-4346-88ea-69c6ac5a56bc 59535-6201 HUMAN OTC DRUG Vitalizer Fluid Allantoin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .001 g/mL E 20171231 59535-6301_4bcee347-7267-48e9-a27a-18a2feec1134 59535-6301 HUMAN OTC DRUG Vitalizer White DEXPANTHENOL LIQUID TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part347 AMI Cosmetic Co.,Ltd. DEXPANTHENOL .0005 g/mL E 20171231 59535-6401_3c9604ad-5480-4683-8ba0-1169ef0a6f6b 59535-6401 HUMAN OTC DRUG Vitalizer White Glycerin GEL TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .015 g/mL E 20171231 59535-6501_2e0bcad4-c291-439d-89ce-4a431941f42f 59535-6501 HUMAN OTC DRUG Vitalizer C10 Ampoule Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .001 g/mL E 20171231 59535-6601_730a9477-21b1-48c7-a95a-6135312fedd4 59535-6601 HUMAN OTC DRUG Bubble Refining Cleanser Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL E 20171231 59535-6701_290d9952-5acf-4ae5-ae68-2905aa337da5 59535-6701 HUMAN OTC DRUG Blemish Serum Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL E 20171231 59535-6801_a0498c6f-8dc3-4ecc-8e68-73f65b20f16d 59535-6801 HUMAN OTC DRUG Blemish Soothing Moisturizer Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/mL E 20171231 59535-6901_007c4576-5b4e-4c8c-9aac-10d6d2af92bf 59535-6901 HUMAN OTC DRUG Blemish Allantoin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .0005 g/mL E 20171231 59535-7001_08f5eaf7-c280-48b2-95b5-027827f558ee 59535-7001 HUMAN OTC DRUG MAX HYALURONIC FORMULA AMPOULE GLYCERIN LIQUID TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL E 20171231 59535-7101_3137afdf-4d20-45b3-a974-26516704f5b1 59535-7101 HUMAN OTC DRUG Blemish Potion Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .05 g/mL E 20171231 59535-7201_d26b16e9-32c4-45a4-acf6-78df7a5c464d 59535-7201 HUMAN OTC DRUG Aqua Rush Serum Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .1 g/mL E 20171231 59535-7301_6da39c10-134c-4a25-b2fa-f3260c2a1a14 59535-7301 HUMAN OTC DRUG Aqua Rush Water Drop BB TITANIUM DIOXIDE CREAM TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part352 AMI Cosmetic Co.,Ltd. TITANIUM DIOXIDE .0934 g/g E 20171231 59535-7401_c9b9a0e2-41a7-4e68-8e78-e5de46c6ea74 59535-7401 HUMAN OTC DRUG Aqua Rush Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .084 g/mL E 20171231 59535-7501_3ad3193d-ee11-418d-bfad-06373d320fb1 59535-7501 HUMAN OTC DRUG Aqua Rush Fluid Allantoin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .001 g/mL E 20171231 59535-7601_da2d3b69-3632-495f-952b-b674369f0cfd 59535-7601 HUMAN OTC DRUG Aqua Rush Cover Cushion Glycerin POWDER TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .0000167 g/g E 20171231 59535-7701_7d0bbecc-edc1-4ffa-8fe7-291d4bac6384 59535-7701 HUMAN OTC DRUG Jasmine 3D Moist Glycerin POWDER TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .1 g/g E 20171231 59535-7801_6acbdcc5-5341-4602-8f04-3a7d18e8da5a 59535-7801 HUMAN OTC DRUG Jasmine 3D Moist Pact Allantoin POWDER TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .002 g/g E 20171231 59535-7901_3588538e-1c7c-4811-8d42-4187658e5c51 59535-7901 HUMAN OTC DRUG Jasmine 3D Whipping Essence Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .002 g/mL E 20171231 59535-8001_c5637e58-3393-41a8-8480-d1a337df5b51 59535-8001 HUMAN OTC DRUG MAX HYALURONIC STEMCELL BB ZINC OXIDE CREAM TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .0098 g/g E 20171231 59535-8101_5ab251f2-f70e-458d-b848-bf3d3f640019 59535-8101 HUMAN OTC DRUG Jasmine Water Cover Cushion Zinc oxide LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .02 g/g E 20171231 59535-8201_b234b3df-73ee-430a-a45b-021ab82003c8 59535-8201 HUMAN OTC DRUG Ginseng Stemcell Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .08 g/g E 20171231 59535-8301_f38aeb8c-e73e-4496-a650-37e717ddc0cb 59535-8301 HUMAN OTC DRUG Power Aqua Balancing Toner Allantoin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .002 g/mL E 20171231 59535-8401_df53dd9a-e323-455a-93fa-da7c2a025755 59535-8401 HUMAN OTC DRUG Power Defence Smart Allantoin EMULSION TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .002 g/mL E 20171231 59535-8501_ac5fdfc8-8cda-482c-9450-67521dcb6073 59535-8501 HUMAN OTC DRUG Perfect Calming BB Remover Allantoin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .001 g/mL E 20171231 59535-8601_849b1f26-1728-4dbf-b92f-4f328fd93347 59535-8601 HUMAN OTC DRUG Perfect Calming Serum Allantoin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .0005 g/mL E 20171231 59535-8701_d7330022-eb1b-4b2a-8a76-3155a76cb541 59535-8701 HUMAN OTC DRUG Perfect Calming Glycerin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .03 g/mL E 20171231 59535-8801_04548753-7e03-4e47-9c61-e6e1f76fade6 59535-8801 HUMAN OTC DRUG Perfect Calming Toner Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/mL E 20171231 59535-8901_8931c7e6-526b-4c2f-b5a0-e3b94d526857 59535-8901 HUMAN OTC DRUG Perfect Pore Clean I DEXPANTHENOL LIQUID TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part347 AMI Cosmetic Co.,Ltd. DEXPANTHENOL .001 g/mL E 20171231 59535-9001_6e65fb17-4e15-4759-b71b-ca87a1e021e3 59535-9001 HUMAN OTC DRUG PROPOLIS 90 AMPOULE ZINC OXIDE LIQUID TOPICAL 20130726 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ZINC OXIDE .0098 g/mL E 20171231 59535-9101_a9eb61ab-fde6-46a6-a055-a310e308952c 59535-9101 HUMAN OTC DRUG Whitening Repairing BB Allantoin CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .0005 g/g E 20171231 59535-9201_6aea9620-a389-4ec3-8ce5-4f6f139920d8 59535-9201 HUMAN OTC DRUG Whitening Repairing Cover Cushion Allantoin POWDER TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. ALLANTOIN .0001 g/g E 20171231 59535-9301_65fe35b6-c7ff-4e38-8235-20a0c5104cae 59535-9301 HUMAN OTC DRUG Vitamin A Velvet Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/g E 20171231 59535-9401_713fa36d-6493-4ec6-bbbf-18ff6f8576fb 59535-9401 HUMAN OTC DRUG Vitamin B5 Velvet Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/g E 20171231 59535-9501_99b21ac7-60c5-4363-b0a4-66ab42592cc5 59535-9501 HUMAN OTC DRUG Vitamin C Velvet Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/g E 20171231 59535-9601_5814bfb4-09d7-4969-b7a6-e06f3bfe3632 59535-9601 HUMAN OTC DRUG Vitamin E Velvet Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/g E 20171231 59535-9701_3ae3bc63-5a6b-45d2-86dd-65ed03ad1f98 59535-9701 HUMAN OTC DRUG Vitamin F Velvet Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .06 g/g E 20171231 59535-9801_5311175c-7e6c-4563-b72b-f741989cb7c8 59535-9801 HUMAN OTC DRUG Vitamin H Velvet Mask Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/g E 20171231 59535-9901_1ae858e1-85c1-49f4-85e8-e8e3f67e22c2 59535-9901 HUMAN OTC DRUG Super Aqua Cleansing Oil Glycerin LIQUID TOPICAL 20140414 OTC MONOGRAPH FINAL part347 AMI Cosmetic Co.,Ltd. GLYCERIN .04 g/mL E 20171231 59538-001_2d2779a3-d793-4635-8509-44e775a916dd 59538-001 HUMAN OTC DRUG biokera PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20130801 OTC MONOGRAPH FINAL part358H SALERM COSMETICA PROFESIONAL, S.A. PYRITHIONE ZINC 1 g/10g E 20171231 59538-002_85d20684-72b9-4650-acba-b24d882f4db7 59538-002 HUMAN OTC DRUG biokera PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20130801 OTC MONOGRAPH FINAL part358H SALERM COSMETICA PROFESIONAL, S.A. PYRITHIONE ZINC .5 g/10g E 20171231 59538-003_261544ea-cc32-46e4-99f8-ff2bf7ebdf9e 59538-003 HUMAN OTC DRUG biokera PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20130801 OTC MONOGRAPH FINAL part358H SALERM COSMETICA PROFESIONAL, S.A. PYRITHIONE ZINC .1 g/10g E 20171231 59538-004_6d7bd401-d7ba-44eb-9be7-b3c1b38e85da 59538-004 HUMAN OTC DRUG biokera PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H SALERM COSMETICA PROFESIONAL, S.A. PYRITHIONE ZINC 1 g/10g E 20171231 59543-1001_5cdc4584-d800-44c9-98f5-81d0342ae77d 59543-1001 HUMAN OTC DRUG WeTTrust Gold Glycerin GEL VAGINAL 20130729 OTC MONOGRAPH FINAL part346 WeTTrust Korea Co., Ltd GLYCERIN .17 g/g E 20171231 59543-2001_22963d1f-6027-41bc-af47-e998fd7c0c0c 59543-2001 HUMAN OTC DRUG Inclear Glycerin GEL VAGINAL 20130729 OTC MONOGRAPH FINAL part346 WeTTrust Korea Co., Ltd GLYCERIN .04 g/g E 20171231 59543-3001_57738671-4a5a-492f-8204-3733a70e38c2 59543-3001 HUMAN OTC DRUG Inclear Glycerin GEL VAGINAL 20130729 OTC MONOGRAPH FINAL part346 WeTTrust Korea Co., Ltd GLYCERIN .04 g/g E 20171231 59543-5001_f3dc4d33-3d37-4e3d-9155-7276512bb8c5 59543-5001 HUMAN OTC DRUG WeTTrust Gold Vaginal Care Essence Glycerin GEL VAGINAL 20150201 OTC MONOGRAPH FINAL part346 WeTTrust Korea Co., Ltd GLYCERIN .306 g/101 N 20181231 59543-5002_8b05fa3c-71be-4825-a313-eefc34c594b0 59543-5002 HUMAN OTC DRUG WeTTrust Inclear Glycerin GEL VAGINAL 20150201 OTC MONOGRAPH FINAL part346 WeTTrust Korea Co., Ltd GLYCERIN .11 g/101 N 20181231 59547-210_045baa49-d22c-4ed8-8dd6-b90565eca017 59547-210 HUMAN PRESCRIPTION DRUG Glycate Glycopyrrolate TABLET ORAL 20120312 ANDA ANDA091522 Nuro Pharma, Inc. GLYCOPYRROLATE 1.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 59555-102_5200b3a2-ded0-48bf-93ed-7e6d3213f562 59555-102 HUMAN OTC DRUG Industrial Strength Sunscreen Zinc Oxide, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20151221 OTC MONOGRAPH NOT FINAL part352 R & R Lotion, Inc ZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE 64; 59; 38; 47 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 59555-103_edd9bb1d-66f4-449f-be4b-951ff7f5adb3 59555-103 HUMAN OTC DRUG Desert Spirit Sunscreen Zinc Oxide, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20151221 OTC MONOGRAPH NOT FINAL part352 R & R Lotion, Inc ZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE 64; 59; 38; 47 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 59555-104_7ec754a7-df94-415d-be86-829f91f75b25 59555-104 HUMAN OTC DRUG Royal and Ancient Suncreen Zinc Oxide, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20151221 OTC MONOGRAPH NOT FINAL part352 R & R Lotion, Inc ZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE 64; 59; 38; 47 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 59555-105_a4041ac1-72e1-4e5e-8fef-d174aa41a59e 59555-105 HUMAN OTC DRUG Lifeguard Sunscreen Zinc Oxide, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20151221 OTC MONOGRAPH NOT FINAL part352 R & R Lotion, Inc ZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE 64; 59; 38; 47 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 59555-106_5de22e3d-001c-442e-929a-d31f85941699 59555-106 HUMAN OTC DRUG Pura Vida Sunscreen Zinc Oxide, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20151221 OTC MONOGRAPH NOT FINAL part352 R & R Lotion, Inc ZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE 64; 59; 38; 47 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 59555-401_5a2a436b-c816-44e6-a821-d42c9beeb46e 59555-401 HUMAN OTC DRUG I.C. Hand Sanitizer Benzalkonium Chloride AEROSOL, FOAM TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part333A R&R Lotion, Inc. BENZALKONIUM CHLORIDE 1 mg/mL E 20171231 59555-402_8b10430b-1e2a-4d05-bc0a-0d377cc51c88 59555-402 HUMAN OTC DRUG Industrial Foaming Hand Sanitizer Benzalkonium Chloride AEROSOL, FOAM TOPICAL 20151221 OTC MONOGRAPH NOT FINAL part333A R & R Lotion, Inc BENZALKONIUM CHLORIDE 1 mg/mL E 20171231 59555-601_87ba9574-fefc-42ba-a21a-c297eb721453 59555-601 HUMAN OTC DRUG I.C. Barrier Benzethonium Chloride and Dimethicone LOTION/SHAMPOO TOPICAL 20140917 OTC MONOGRAPH NOT FINAL part333A R&R Lotion, Inc. BENZETHONIUM CHLORIDE; DIMETHICONE 2; 20 mg/mL; mg/mL E 20171231 59555-801_8b930340-55f7-4bbe-9577-442ba30cc1a5 59555-801 HUMAN OTC DRUG Moisturizing Cream Dimethicone LOTION TOPICAL 20151221 OTC MONOGRAPH FINAL part347 R & R Lotion, Inc DIMETHICONE 40 mg/mL E 20171231 59555-901_132d031c-283d-4c1d-88ed-61406a70436e 59555-901 HUMAN OTC DRUG I.C. Hand Sanitizer Benzethonium Chloride and Dimethicone LOTION TOPICAL 20151221 OTC MONOGRAPH NOT FINAL part333A R&R Lotion, Inc. BENZETHONIUM CHLORIDE; DIMETHICONE 2; 20 mg/mL; mg/mL E 20171231 59555-902_5bb917ab-d40f-4b27-8a7a-9e653fcc8199 59555-902 HUMAN OTC DRUG Industrial Sanitizing Benzethonium Chloride and Dimethicone LOTION TOPICAL 20151221 OTC MONOGRAPH NOT FINAL part333A R&R Lotion, Inc. BENZETHONIUM CHLORIDE; DIMETHICONE 2; 20 mg/mL; mg/mL E 20171231 59556-007_82d20232-4f22-4220-88da-8f8445d79e30 59556-007 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20130504 ANDA ANDA200770 Strides Pharma Inc HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 59556-008_82d20232-4f22-4220-88da-8f8445d79e30 59556-008 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20130504 ANDA ANDA200770 Strides Pharma Inc HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 59556-009_82d20232-4f22-4220-88da-8f8445d79e30 59556-009 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20130504 ANDA ANDA200770 Strides Pharma Inc HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 59556-762_7f774d18-0334-4892-9e32-23ef60043245 59556-762 HUMAN OTC DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20160825 ANDA ANDA203928 Strides Pharma Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 59556-769_ad90469d-d5d5-40e6-909f-455afde9034a 59556-769 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20170721 ANDA ANDA205291 Strides Pharma Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 59556-805_ea87a1e7-61da-4204-b8fb-82a028bba42f 59556-805 HUMAN OTC DRUG IBUPROFEN IMMEDIATE RELEASE IBUPROFEN TABLET, COATED ORAL 20160826 ANDA ANDA207052 Strides Pharma Inc. IBUPROFEN 200 mg/1 N 20181231 59556-806_ea87a1e7-61da-4204-b8fb-82a028bba42f 59556-806 HUMAN OTC DRUG IBUPROFEN IMMEDIATE RELEASE IBUPROFEN TABLET, COATED ORAL 20160826 ANDA ANDA207052 Strides Pharma Inc. IBUPROFEN 200 mg/1 N 20181231 59556-810_d5b425bb-8a90-4175-bf00-b771d28ca76b 59556-810 HUMAN OTC DRUG vanquish acetaminophen, aspirin, and caffeine TABLET, COATED ORAL 20120626 OTC MONOGRAPH NOT FINAL part343 Strides Pharma Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 194; 227; 33 mg/1; mg/1; mg/1 N 20181231 59556-813_2b2dba2b-a83c-44f8-82d8-24f71d602443 59556-813 HUMAN OTC DRUG JOINTFLEX camphor CREAM TOPICAL 20100416 OTC MONOGRAPH NOT FINAL part348 Strides Pharma Inc CAMPHOR (SYNTHETIC) 3.58 g/114g N 20181231 59556-850_f65dc1fd-8443-4a2f-8a9c-65f6cf6ca50f 59556-850 HUMAN OTC DRUG Pediacare Childrens Cough And Congestion dextromethorphan hydrobromide and guaifenesin LIQUID ORAL 20100712 OTC MONOGRAPH FINAL part341 Strides Pharma Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 59556-851_47e170ff-bf79-4ebb-8d6e-eb561633cd25 59556-851 HUMAN OTC DRUG PediaCare Multi Symptom Cold Acetaminophen,Chlorpheniramine maleate,Dextromethorphan HBr,Phenylephrine HCl LIQUID ORAL 20100709 OTC MONOGRAPH FINAL part341 Strides Pharma Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 59556-852_bcc0968d-99b0-4857-886a-c60358ce4b10 59556-852 HUMAN OTC DRUG Pediacare-Cough-RunnyNose acetaminophen,chlorpheniramine maleate,dextromethorphan LIQUID ORAL 20100709 OTC MONOGRAPH FINAL part341 Strides Pharma Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 59556-853_c7e57512-6d5f-41ba-b3cb-fb9e43c2f73c 59556-853 HUMAN OTC DRUG Pediacare SIMETHICONE ANTIGAS simethicone EMULSION ORAL 20110801 OTC MONOGRAPH FINAL part332 Strides Pharma Inc SILICON DIOXIDE; DIMETHICONE .011; .211 g/mL; g/mL N 20181231 59556-854_db20f8ca-8b1d-471c-a5e3-870a7431ad17 59556-854 HUMAN OTC DRUG PediaCare Childrens Fever Reducer Pain Reliever Cherry Acetaminophen LIQUID ORAL 20100708 OTC MONOGRAPH NOT FINAL part343 Strides Pharma Inc ACETAMINOPHEN 160 mg/5mL N 20181231 59556-855_1f4159ad-d58c-4519-932b-030cc2735514 59556-855 HUMAN OTC DRUG Ibuprofen Immediate Release Ibuprofen TABLET, COATED ORAL 20110404 ANDA ANDA091355 Strides Pharma Inc. IBUPROFEN 200 mg/1 N 20181231 59556-856_1f4159ad-d58c-4519-932b-030cc2735514 59556-856 HUMAN OTC DRUG Ibuprofen Immediate Release Ibuprofen TABLET, COATED ORAL 20110404 ANDA ANDA091355 Strides Pharma Inc. IBUPROFEN 200 mg/1 N 20181231 59561-001_1e87f799-696a-49d2-a852-94b345f24951 59561-001 HUMAN OTC DRUG Anesgerm Benzocaine GEL ORAL 20150430 OTC MONOGRAPH NOT FINAL part356 Caribe Natural, Inc BENZOCAINE .2 g/100g E 20171231 59561-100_2338666e-ffaf-455a-b4c2-0e47d29fabe4 59561-100 HUMAN OTC DRUG Germa Arnica Relief arnica montana GEL TOPICAL 20150623 UNAPPROVED HOMEOPATHIC Caribe Natural LLC ARNICA MONTANA 1 [hp_X]/100g N 20181231 59561-101_7d926a57-639f-4fac-8d27-a0288e788248 59561-101 HUMAN OTC DRUG Germa Arnica Montana 30C Arnica Montana TABLET ORAL 20150409 UNAPPROVED HOMEOPATHIC Caribe Natural, Inc. ARNICA MONTANA 30 [hp_C]/1 N 20181231 59561-102_6dc6bfa0-6ed9-4ea3-bf04-eec015fa2398 59561-102 HUMAN OTC DRUG Artico Ice menthol GEL TOPICAL 20150504 OTC MONOGRAPH NOT FINAL part348 Caribe Natural, Inc MENTHOL 1 g/100g E 20171231 59561-202_e90ddf21-87ce-462b-8344-5a578b17d52c 59561-202 HUMAN OTC DRUG BRONCO SILEN-DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN SOLUTION ORAL 20151105 OTC MONOGRAPH FINAL part341 Caribe Natural, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL E 20171231 59561-703_6bd12a64-9929-42e9-8cb8-d8043b1f3d66 59561-703 HUMAN OTC DRUG Camphor Camphor OINTMENT TOPICAL 20150505 OTC MONOGRAPH NOT FINAL part348 Caribe Natural, Inc CAMPHOR (NATURAL) 10 g/100g E 20171231 59561-706_8a6e226b-7b9d-484f-b9a5-64d4bbf5b898 59561-706 HUMAN OTC DRUG Sulfur Sulfur OINTMENT TOPICAL 20150505 OTC MONOGRAPH FINAL part333D Caribe Natural, Inc SULFUR 10 g/100g E 20171231 59561-708_7b755c96-4862-4ba0-919d-374436128a60 59561-708 HUMAN OTC DRUG Mercurochrome Benzalkonium Chloride CREAM TOPICAL 20150505 OTC MONOGRAPH NOT FINAL part333A Caribe Natural, Inc BENZALKONIUM CHLORIDE .13 g/100g E 20171231 59561-709_5b42c72b-3a74-43eb-b34a-bb061ec026de 59561-709 HUMAN OTC DRUG Merthiolate Benzalkonium Chloride CREAM TOPICAL 20150505 OTC MONOGRAPH NOT FINAL part333A Caribe Natural, Inc BENZALKONIUM CHLORIDE .13 g/100g E 20171231 59561-712_79501f0c-43b5-4c65-b77b-fc761b31185b 59561-712 HUMAN OTC DRUG QuitaCallos salicylic acid CREAM TOPICAL 20150505 OTC MONOGRAPH FINAL part358F Caribe Natural, Inc SALICYLIC ACID 17 g/100g E 20171231 59561-901_ee920ac1-92cf-4556-ad2a-b453059b1a09 59561-901 HUMAN OTC DRUG Verruguin Salicylic Acid GEL TOPICAL 20150505 OTC MONOGRAPH FINAL part358B Caribe Natural, Inc SALICYLIC ACID 17 g/100g E 20171231 59564-251_603b96bf-ab3f-4ac2-966b-8060f1cfe745 59564-251 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20081201 ANDA ANDA076134 Innovative Manufacturing and Distribution Services, Inc. LORATADINE 10 mg/1 N 20181231 59567-001_8679eaaa-9637-4fb5-af98-5af021179636 59567-001 HUMAN OTC DRUG Capent Diaper Rash Zinc Oxide Lanolin OINTMENT TOPICAL 20130301 OTC MONOGRAPH FINAL part347 Laboratorios Columbia S.A. de C.V. ZINC OXIDE; LANOLIN 25; 15.5 g/100g; g/100g E 20171231 59572-102_2ee396fc-bd5b-444a-8f18-0760c6e7c4cf 59572-102 HUMAN PRESCRIPTION DRUG VIDAZA azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20040705 NDA NDA050794 Celgene Corporation AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 59572-205_0ef5e838-f546-4568-96d1-5d1459b849ec 59572-205 HUMAN PRESCRIPTION DRUG Thalomid Thalidomide CAPSULE ORAL 20030620 NDA NDA020785 Celgene Corporation THALIDOMIDE 50 mg/1 Decreased Immunologically Active Molecule Activity [PE] N 20181231 59572-210_0ef5e838-f546-4568-96d1-5d1459b849ec 59572-210 HUMAN PRESCRIPTION DRUG Thalomid Thalidomide CAPSULE ORAL 20030620 NDA NDA020785 Celgene Corporation THALIDOMIDE 100 mg/1 Decreased Immunologically Active Molecule Activity [PE] N 20181231 59572-215_0ef5e838-f546-4568-96d1-5d1459b849ec 59572-215 HUMAN PRESCRIPTION DRUG Thalomid Thalidomide CAPSULE ORAL 20070320 NDA NDA020785 Celgene Corporation THALIDOMIDE 150 mg/1 Decreased Immunologically Active Molecule Activity [PE] N 20181231 59572-220_0ef5e838-f546-4568-96d1-5d1459b849ec 59572-220 HUMAN PRESCRIPTION DRUG Thalomid Thalidomide CAPSULE ORAL 20030620 NDA NDA020785 Celgene Corporation THALIDOMIDE 200 mg/1 Decreased Immunologically Active Molecule Activity [PE] N 20181231 59572-402_3ea96a6f-c2ba-4f27-bc8b-b6d7ee2aee60 59572-402 HUMAN PRESCRIPTION DRUG Revlimid Lenalidomide CAPSULE ORAL 20120416 NDA NDA021880 Celgene Corporation LENALIDOMIDE 2.5 mg/1 Thalidomide Analog [EPC] N 20181231 59572-405_3ea96a6f-c2ba-4f27-bc8b-b6d7ee2aee60 59572-405 HUMAN PRESCRIPTION DRUG Revlimid Lenalidomide CAPSULE ORAL 20051227 NDA NDA021880 Celgene Corporation LENALIDOMIDE 5 mg/1 Thalidomide Analog [EPC] N 20181231 59572-410_3ea96a6f-c2ba-4f27-bc8b-b6d7ee2aee60 59572-410 HUMAN PRESCRIPTION DRUG Revlimid Lenalidomide CAPSULE ORAL 20051227 NDA NDA021880 Celgene Corporation LENALIDOMIDE 10 mg/1 Thalidomide Analog [EPC] N 20181231 59572-415_3ea96a6f-c2ba-4f27-bc8b-b6d7ee2aee60 59572-415 HUMAN PRESCRIPTION DRUG Revlimid Lenalidomide CAPSULE ORAL 20060629 NDA NDA021880 Celgene Corporation LENALIDOMIDE 15 mg/1 Thalidomide Analog [EPC] N 20181231 59572-420_3ea96a6f-c2ba-4f27-bc8b-b6d7ee2aee60 59572-420 HUMAN PRESCRIPTION DRUG Revlimid Lenalidomide CAPSULE ORAL 20130606 NDA NDA021880 Celgene Corporation LENALIDOMIDE 20 mg/1 Thalidomide Analog [EPC] N 20181231 59572-425_3ea96a6f-c2ba-4f27-bc8b-b6d7ee2aee60 59572-425 HUMAN PRESCRIPTION DRUG Revlimid Lenalidomide CAPSULE ORAL 20060629 NDA NDA021880 Celgene Corporation LENALIDOMIDE 25 mg/1 Thalidomide Analog [EPC] N 20181231 59572-501_d3789edf-8510-4ee8-9e98-7afb93a9fd8d 59572-501 HUMAN PRESCRIPTION DRUG Pomalyst pomalidomide CAPSULE ORAL 20130218 NDA NDA204026 Celgene Corporation POMALIDOMIDE 1 mg/1 Thalidomide Analog [EPC] N 20181231 59572-502_d3789edf-8510-4ee8-9e98-7afb93a9fd8d 59572-502 HUMAN PRESCRIPTION DRUG Pomalyst pomalidomide CAPSULE ORAL 20130218 NDA NDA204026 Celgene Corporation POMALIDOMIDE 2 mg/1 Thalidomide Analog [EPC] N 20181231 59572-503_d3789edf-8510-4ee8-9e98-7afb93a9fd8d 59572-503 HUMAN PRESCRIPTION DRUG Pomalyst pomalidomide CAPSULE ORAL 20130218 NDA NDA204026 Celgene Corporation POMALIDOMIDE 3 mg/1 Thalidomide Analog [EPC] N 20181231 59572-504_d3789edf-8510-4ee8-9e98-7afb93a9fd8d 59572-504 HUMAN PRESCRIPTION DRUG Pomalyst pomalidomide CAPSULE ORAL 20130218 NDA NDA204026 Celgene Corporation POMALIDOMIDE 4 mg/1 Thalidomide Analog [EPC] N 20181231 59572-630_66cc5840-c6ed-498d-b82b-45c7cb6fc578 59572-630 HUMAN PRESCRIPTION DRUG OTEZLA apremilast KIT ORAL 20140325 NDA NDA205437 Celgene Corporation N 20181231 59572-631_66cc5840-c6ed-498d-b82b-45c7cb6fc578 59572-631 HUMAN PRESCRIPTION DRUG OTEZLA apremilast TABLET, FILM COATED ORAL 20140403 NDA NDA205437 Celgene Corporation APREMILAST 30 mg/1 Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA] N 20181231 59572-632_66cc5840-c6ed-498d-b82b-45c7cb6fc578 59572-632 HUMAN PRESCRIPTION DRUG OTEZLA apremilast KIT ORAL 20150201 NDA NDA205437 Celgene Corporation N 20181231 59572-705_6cd3975b-7970-4c9a-a5e5-f0510bf0d770 59572-705 HUMAN PRESCRIPTION DRUG Idhifa enasidenib mesylate TABLET, FILM COATED ORAL 20170801 NDA NDA209606 Celgene Corporation ENASIDENIB MESYLATE 50 mg/1 Isocitrate Dehydrogenase 2 Inhibitor [EPC],Isocitrate Dehydrogenase 2 Inhibitors [MoA] N 20181231 59572-710_6cd3975b-7970-4c9a-a5e5-f0510bf0d770 59572-710 HUMAN PRESCRIPTION DRUG Idhifa enasidenib mesylate TABLET, FILM COATED ORAL 20170801 NDA NDA209606 Celgene Corporation ENASIDENIB MESYLATE 100 mg/1 Isocitrate Dehydrogenase 2 Inhibitor [EPC],Isocitrate Dehydrogenase 2 Inhibitors [MoA] N 20181231 59572-983_442498d3-eb76-478d-b9b7-39ef3acbd709 59572-983 HUMAN PRESCRIPTION DRUG ISTODAX romidepsin KIT 20100104 NDA NDA022393 Celgene Corporation N 20181231 59572-984_442498d3-eb76-478d-b9b7-39ef3acbd709 59572-984 HUMAN PRESCRIPTION DRUG ISTODAX romidepsin KIT 20100104 NDA NDA022393 Celgene Corporation N 20181231 59575-500_b477f21e-c0cc-48cd-8d9d-f3d1da2f1653 59575-500 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part333A Hebei Yihoucheng Commodity Co.,Ltd. BENZALKONIUM CHLORIDE .1 g/100g E 20171231 59575-501_6ecc1ca0-6f7b-4d6d-bb67-841077457c30 59575-501 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130816 OTC MONOGRAPH NOT FINAL part333A Hebei Yihoucheng Commodity Co.,Ltd. BENZALKONIUM CHLORIDE .115 g/100g E 20171231 59578-123_07886a47-32e3-4752-b2df-c544c94e0f4b 59578-123 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20130522 NDA NDA205852 Praxair, Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 59578-498_4237f97d-c495-459a-bec9-3961766fb1fa 59578-498 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20130528 NDA NDA205850 Praxair, Inc. NITROGEN 990 mL/L N 20181231 59578-720_9de0f996-c3dd-4e77-a06a-4d626b1ff465 59578-720 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130522 NDA NDA205849 Praxair, Inc. OXYGEN 990 mL/L N 20181231 59579-001_0874b9d5-d371-4e81-a129-76f0f5b613d5 59579-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20071001 NDA NDA205849 Praxair Distribution, Inc. OXYGEN 990 mL/L N 20191231 59579-002_b9385ae5-3fc0-431e-a9dd-d35fd5e9c696 59579-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20071001 NDA NDA205850 Praxair Distribution, Inc. NITROGEN 990 mL/L N 20191231 59579-003_ed5e677f-9713-4897-9734-826951f4d39d 59579-003 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20080901 UNAPPROVED MEDICAL GAS Praxair Distribution, Inc. CARBON DIOXIDE 990 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 59579-004_3bc88c01-b246-45f4-9422-5aec39f0f27b 59579-004 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution, Inc. NITROUS OXIDE 990 mL/L E 20171231 59579-005_b123fa45-c35d-42ad-9f67-01276083d314 59579-005 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 20071201 NDA NDA205912 Praxair Distribution, Inc. HELIUM 990 mL/L N 20191231 59579-006_23c20ac9-d4ea-4246-a249-319bf4522528 59579-006 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20020501 NDA NDA205910 Praxair Distribution, Inc. AIR 1000 mL/L N 20191231 59579-008_7816b99a-baf0-4540-a91c-55e8dbe90100 59579-008 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mix Carbon Dioxide Oxygen Mix GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution, Inc CARBON DIOXIDE; OXYGEN 300; 700 mL/L; mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 59579-009_9bda423a-2305-4145-b2ae-b6d345d28ac1 59579-009 HUMAN PRESCRIPTION DRUG Helium Oxygen mixture Helium Oxygen mixture GAS RESPIRATORY (INHALATION) 20070801 NDA AUTHORIZED GENERIC NDA205851 Praxair Distribution, Inc. HELIUM; OXYGEN 800; 200 mL/L; mL/L N 20191231 59579-010_f1c08d1e-fb9a-4aff-8da6-ae99d320dd77 59579-010 HUMAN PRESCRIPTION DRUG Helium Oxygen Nitrogen mixture Helium Oxygen Nitrogen mixture GAS RESPIRATORY (INHALATION) 20051001 NDA AUTHORIZED GENERIC NDA205851 Praxair Distribution, Inc. HELIUM; OXYGEN; NITROGEN 200; 500; 300 mL/L; mL/L; mL/L N 20191231 59582-015_997eab00-8eda-4444-931a-06bfa9094b68 59582-015 HUMAN OTC DRUG Black Rice Platinum Absolute Youth SPF 15 Avobenzone, Ensulizole, Octinoxate, and Octocrylene CREAM TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part352 EBPD LLC AVOBENZONE; ENSULIZOLE; OCTINOXATE; OCTOCRYLENE 30; 20; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 59584-138_d44377f4-9394-4e36-a5d0-a980ab30ccef 59584-138 STANDARDIZED ALLERGENIC Candin Candida albicans Skin Test Antigen INJECTION, SOLUTION INTRADERMAL 19951201 BLA BLA103257 Nielsen BioSciences, Inc. CANDIDA ALBICANS 1 U/.1mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20191231 59584-140_04f0d499-26c5-1d4c-e054-00144ff88e88 59584-140 HUMAN PRESCRIPTION DRUG Spherusol Coccidioides immitis Spherule-Derived Skin Test Antigen INJECTION, SOLUTION INTRADERMAL 20110729 BLA BLA125354 Nielsen BioSciences, Inc. COCCIDIOIDES IMMITIS SPHERULE 12.7 ug/mL Skin Test Antigen [EPC],Cell-mediated Immunity [PE],Antigens, Fungal [Chemical/Ingredient] N 20181231 59608-001_726fa52a-9b82-496e-81ba-608f87f3788a 59608-001 HUMAN OTC DRUG TENA Protective Cream Zinc Oxide CREAM TOPICAL 20131003 OTC MONOGRAPH FINAL part347 SCA Personal Care Inc. ZINC OXIDE 100 mg/mL N 20181231 59608-002_24c2a581-da2f-40fc-a806-f73820337681 59608-002 HUMAN OTC DRUG TENA DIMETHICONE moisturizing lotion CREAM TOPICAL 20170528 OTC MONOGRAPH FINAL part347 SCA Personal Care Inc. DIMETHICONE .01 g/100mL N 20181231 59608-003_4cae6538-9bea-4bdd-8ba6-d4b1b5029791 59608-003 HUMAN OTC DRUG TENA ZINC OXIDE Protective Cream LOTION TOPICAL 20170607 OTC MONOGRAPH FINAL part347 SCA Personal Care Inc. ZINC OXIDE 10 g/100mL N 20181231 59608-004_645d6f37-3d0f-4c95-a95c-6a5b0229dbed 59608-004 HUMAN OTC DRUG TENA DIMETHICONE moisturizing lotion CREAM TOPICAL 20170528 OTC MONOGRAPH FINAL part347 SCA Personal Care Inc. DIMETHICONE .01 g/100mL N 20181231 59614-221_10ada59f-faaf-47e7-b15a-b96e5118ebe1 59614-221 HUMAN OTC DRUG Sun Protection Emulsion Face la prairie Avobenzone, Homosalate, octisalate, octocrylene, oxybenzone CREAM TOPICAL 20110214 OTC MONOGRAPH FINAL part352 Juvena GMBH AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 2.5; 2.4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 59614-301_57da029e-b645-4e14-8bcf-659432050e0d 59614-301 HUMAN OTC DRUG La Prairie Switzerland Cellular Radiance Emulsion Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Juvena Produits de Beaute AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 mL/100mL; mL/100mL; mL/100mL E 20171231 59614-311_148adfb5-b153-4f3f-b5bc-b040c2f8e63b 59614-311 HUMAN OTC DRUG La Prairie Switzerland Cellular Blemish Control Salicylic Acid CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Juvena Produits de Beaute GMBH SALICYLIC ACID 2 mCi/100mL E 20171231 59614-347_8c46e5a4-f552-4a5b-bab3-ad2d2bab6959 59614-347 HUMAN PRESCRIPTION DRUG La Prairie Switzerland Anti-Aging Day Cream SPF 30 Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20080101 OTC MONOGRAPH FINAL part352 Juvena Produits de Beaute GMBH AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 7.5; 5; 2.5 mL/100mL; mL/100mL; mL/5mL; mL/100mL E 20171231 59614-411_6b94b7e6-b3f0-40da-94e8-1c3c906fafb7 59614-411 HUMAN OTC DRUG La Prairie Switzerland Anti-Wrinkle SunScreen SPF 30 Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Juvena Produits de Beaute GMBH AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 2.6; 2.4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 59614-511_b89511ec-8fc8-4c35-8600-320f915312f6 59614-511 HUMAN OTC DRUG Sun protection body SPF 30 Avobenzone, Homosalate, Octislate, Oxybenzone LOTION TOPICAL 20110214 OTC MONOGRAPH FINAL part352 Juvena Produits de Beaute GMBH AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 7; 5; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 59614-738_afcf314c-3245-4813-95e5-cfd0fa28d496 59614-738 HUMAN OTC DRUG Ultra Protection stick La prarie Switerland Avobenzone, Homosalate, Octisalate, Oxybenzone STICK TOPICAL 20110214 OTC MONOGRAPH FINAL part352 Juvena Produits De Beaute GMBH AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 7; 5; 2 g/100g; g/100g; g/100g; g/100g E 20171231 59617-0010_08317321-144b-488d-8756-6f847731ae45 59617-0010 STANDARDIZED ALLERGENIC Oralair 100 IR ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20140430 BLA BLA125471 Stallergenes ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 100; 100; 100; 100; 100 [IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1 Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 59617-0015_08317321-144b-488d-8756-6f847731ae45 59617-0015 STANDARDIZED ALLERGENIC Oralair 300 IR ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20140430 BLA BLA125471 Stallergenes ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 300; 300; 300; 300; 300 [IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1 Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 59617-0016_08317321-144b-488d-8756-6f847731ae45 59617-0016 STANDARDIZED ALLERGENIC Oralair 300 IR ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20140430 BLA BLA125471 Stallergenes ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN 300; 300; 300; 300; 300 [IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1 Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 59617-0020_08317321-144b-488d-8756-6f847731ae45 59617-0020 STANDARDIZED ALLERGENIC Oralair ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN KIT 20140430 BLA BLA125471 Stallergenes N 20181231 59617-0025_08317321-144b-488d-8756-6f847731ae45 59617-0025 STANDARDIZED ALLERGENIC Oralair ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN KIT 20140430 BLA BLA125471 Stallergenes N 20181231 59623-001_b2abb503-f766-40ab-8e84-f05e9789d847 59623-001 HUMAN OTC DRUG Seasonal Allergy Formula Hydrastis Canadensis, Kali Muriaticum, Gelsemium Sempervirens, Kali Bichromicum, Sabadilla, Histaminum, House Dust, Grass Mix, Trees Mix, Weeds Mix LIQUID ORAL 20130722 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC GOLDENSEAL; POTASSIUM CHLORIDE; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; HISTAMINE DIHYDROCHLORIDE; HOUSE DUST; ANTHOXANTHUM ODORATUM; BROMUS SECALINUS POLLEN; CYNODON DACTYLON POLLEN; BARLEY; SORGHUM HALEPENSE POLLEN; POA PRATENSIS POLLEN; MELILOTUS OFFICINALIS TOP; PHLEUM PRATENSE TOP; TRITICUM AESTIVUM POLLEN; ZEA MAYS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; SOLIDAGO VIRGAUREA POLLEN; ARTEMISIA VULGARIS POLLEN; ALNUS RUBRA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA LENTA POLLEN; BETULA PUBESCENS FLOWER BUD; ACER NEGUNDO POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; ULMUS RUBRA POLLEN; CARYA GLABRA POLLEN; CARYA OVATA POLLEN; CARYA LACINIOSA POLLEN; CARYA TOMENTOSA POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; QUERCUS MARILANDICA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; PINUS NIGRA POLLEN; PINUS TAEDA POLLEN; PINUS SYLVESTRIS POLLEN; PINUS STROBUS POLLEN; MORUS RUBRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS REGIA POLLEN; POPULUS ALBA POLLEN; PLANTAGO LANCEOLATA POLLEN 4; 6; 12; 12; 12; 30; 12; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 59623-004_b6097cf8-c538-42c2-8249-f16f2f8c52c4 59623-004 HUMAN OTC DRUG Breathe Easier Formula Cupressus Aus, Eucalyptus, Mentha Pip, Origanum, Pinus Syl, Salvia, Kali Iod, Euphorbium, Galphimia, Hydrastis, Luffa, Pulsatilla, Hepar Suplh Calc, Histaminum, Kali Bic. SPRAY NASAL 20130923 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC CUPRESSUS SEMPERVIRENS FRUITING LEAFY TWIG; EUCALYPTUS GLOBULUS LEAF; MENTHA PIPERITA; ORIGANUM MAJORANA WHOLE; PINUS SYLVESTRIS LEAFY TWIG; SAGE; POTASSIUM IODIDE; EUPHORBIA RESINIFERA RESIN; GALPHIMIA GLAUCA FLOWERING TOP; GOLDENSEAL; LUFFA OPERCULATA FRUIT; PULSATILLA VULGARIS; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; POTASSIUM DICHROMATE 3; 3; 3; 3; 3; 3; 4; 6; 6; 6; 6; 6; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 59623-005_43c5f200-7fe1-48f6-ba0b-3a52a89763ce 59623-005 HUMAN OTC DRUG Cold and Flu Formula Aconitum Napellus, Gelsemium Sempervirens, Ruta Graveolens, Ambra Grisea, Kali Carbonicum, Natrum Muriaticum, Bryonia Alba, Anas Barbariae, Cenchris Contortrix, Influenzinum. LIQUID ORAL 20131104 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; RUTA GRAVEOLENS FLOWERING TOP; AMBERGRIS; POTASSIUM CARBONATE; SODIUM CHLORIDE; BRYONIA ALBA ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; AGKISTRODON CONTORTRIX VENOM; INFLUENZA A VIRUS; INFLUENZA B VIRUS 3; 4; 5; 6; 6; 6; 12; 30; 30; 34; 34 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 59623-006_f8723aa9-3720-4701-877c-9c82734e1337 59623-006 HUMAN OTC DRUG Cedar X Formula Olibanum, Thuja Occidentalis, Gelsemium Sempervirens, Allium Cepa, Antimonium Tartaricum, Hepar Sulphuris Calcareum, Juniperus Communis. LIQUID ORAL 20131105 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC FRANKINCENSE; THUJA OCCIDENTALIS LEAFY TWIG; GELSEMIUM SEMPERVIRENS ROOT; ONION; ANTIMONY POTASSIUM TARTRATE; CALCIUM SULFIDE; JUNIPER BERRY 3; 3; 4; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 59623-007_8fc3fa60-e6a4-4b58-9efd-e91c0daf3751 59623-007 HUMAN OTC DRUG Soothing Respiratory Rub Chamomilla, Myrrha, Rosmarinus, Ruta, Symphytum, Antimon Tart. GEL TOPICAL 20150218 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC MATRICARIA RECUTITA; MYRRH; ROSMARINUS OFFICINALIS FLOWERING TOP; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; ANTIMONY POTASSIUM TARTRATE 3; 3; 3; 5; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g N 20181231 59623-013_277e1e1a-9aa3-477f-99f6-8f36bac9fbb1 59623-013 HUMAN OTC DRUG Mold Relief Formula Kali Muriaticum, Gelsemium, Kali Bichromicum, Sabadilla, Histaminum, Mold Mix. LIQUID ORAL 20160501 UNAPPROVED HOMEOPATHIC Integrative Healing Institute, LLC POTASSIUM CHLORIDE; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; HISTAMINE DIHYDROCHLORIDE; ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; BOLETUS SATANAS FRUITING BODY; BOTRYTIS CINEREA; CANDIDA ALBICANS; PASSALORA FULVA; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; RHIZOPUS STOLONIFER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; USTILAGO MAYDIS 6; 12; 12; 12; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 59627-111_a0625754-e759-4190-a35a-bc95f4b809c2 59627-111 HUMAN PRESCRIPTION DRUG AVONEX interferon beta-1a KIT INTRAMUSCULAR 20140829 BLA BLA103628 Biogen Inc. N 20181231 59627-222_a0625754-e759-4190-a35a-bc95f4b809c2 59627-222 HUMAN PRESCRIPTION DRUG AVONEX interferon beta-1a KIT INTRAMUSCULAR 20140829 BLA BLA103628 Biogen Inc. N 20181231 59627-333_a0625754-e759-4190-a35a-bc95f4b809c2 59627-333 HUMAN PRESCRIPTION DRUG AVONEX interferon beta-1a KIT INTRAMUSCULAR 20140829 BLA BLA103628 Biogen Inc. N 20181231 59630-112_f78e3c20-89a0-4a6f-ae60-d6285400bfc3 59630-112 HUMAN PRESCRIPTION DRUG Keflex cephalexin CAPSULE ORAL 19710104 NDA NDA050405 Shionogi Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 59630-113_f78e3c20-89a0-4a6f-ae60-d6285400bfc3 59630-113 HUMAN PRESCRIPTION DRUG Keflex cephalexin CAPSULE ORAL 19710104 NDA NDA050405 Shionogi Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 59630-115_f78e3c20-89a0-4a6f-ae60-d6285400bfc3 59630-115 HUMAN PRESCRIPTION DRUG Keflex cephalexin CAPSULE ORAL 19710104 NDA NDA050405 Shionogi Inc. CEPHALEXIN 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 59630-200_81777c49-9cf0-4835-b791-1b7776d70af9 59630-200 HUMAN PRESCRIPTION DRUG Robinul Glycopyrrolate TABLET ORAL 19610328 NDA NDA012827 Shionogi Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 59630-205_81777c49-9cf0-4835-b791-1b7776d70af9 59630-205 HUMAN PRESCRIPTION DRUG Robinul Forte Glycopyrrolate TABLET ORAL 19610328 NDA NDA012827 Shionogi Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 59630-309_5da5c5ff-5747-5780-e053-2a91aa0a0952 59630-309 HUMAN PRESCRIPTION DRUG Doribax doripenem POWDER, FOR SOLUTION INTRAVENOUS 20101015 NDA NDA022106 Shionogi Inc. DORIPENEM 250 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 59630-320_5da5c5ff-5747-5780-e053-2a91aa0a0952 59630-320 HUMAN PRESCRIPTION DRUG Doribax doripenem POWDER, FOR SOLUTION INTRAVENOUS 20071012 NDA NDA022106 Shionogi Inc. DORIPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 59630-375_00ea44c7-97e5-426f-b0f2-8884e8bfa7dc 59630-375 HUMAN PRESCRIPTION DRUG Naprelan Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960401 NDA NDA020353 Shionogi Inc. NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 59630-400_5da68878-c8b5-c27f-e053-2a91aa0a9e3a 59630-400 HUMAN PRESCRIPTION DRUG Ponstel Mefenamic Acid CAPSULE ORAL 19670328 NDA NDA015034 SHIONOGI INC. MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59630-450_49f55e68-c67b-40bf-a908-742c72229711 59630-450 HUMAN PRESCRIPTION DRUG Furadantin nitrofurantoin SUSPENSION ORAL 19531223 NDA NDA009175 Shionogi Inc. NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 59630-485_a5dd525a-3646-46b6-bb08-3792a1fe2069 59630-485 HUMAN PRESCRIPTION DRUG TRIGLIDE FENOFIBRATE TABLET ORAL 20050507 NDA NDA021350 Shionogi Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 59630-500_afb5a339-f18f-4850-8041-24859b814174 59630-500 HUMAN PRESCRIPTION DRUG SULAR Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19950202 NDA NDA020356 Shionogi Inc. NISOLDIPINE 8.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] E 20171231 59630-501_afb5a339-f18f-4850-8041-24859b814174 59630-501 HUMAN PRESCRIPTION DRUG SULAR Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19950202 NDA NDA020356 Shionogi Inc. NISOLDIPINE 17 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] E 20171231 59630-503_afb5a339-f18f-4850-8041-24859b814174 59630-503 HUMAN PRESCRIPTION DRUG SULAR Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 19950202 NDA NDA020356 Shionogi Inc. NISOLDIPINE 34 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] E 20171231 59630-574_2fe229cb-468f-45f9-ae1e-0d2d09744534 59630-574 HUMAN PRESCRIPTION DRUG FORTAMET metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040427 NDA NDA021574 Shionogi Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 59630-575_2fe229cb-468f-45f9-ae1e-0d2d09744534 59630-575 HUMAN PRESCRIPTION DRUG FORTAMET metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20040427 NDA NDA021574 Shionogi Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 59630-580_c180a4bb-83ea-488f-9ec7-e9ec77c12da7 59630-580 HUMAN PRESCRIPTION DRUG Osphena Ospemifene TABLET, FILM COATED ORAL 20130226 NDA NDA203505 Shionogi Inc. OSPEMIFENE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 59630-629_66a26c72-a564-4355-bd51-8b20728d99de 59630-629 HUMAN PRESCRIPTION DRUG Altoprev lovastatin TABLET, EXTENDED RELEASE ORAL 20020626 20180228 NDA NDA021316 Shionogi Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 59630-750_d3155034-a311-4bc6-bfc2-ddca30d178cb 59630-750 HUMAN PRESCRIPTION DRUG Methylin Methylphenidate Hydrochloride SOLUTION ORAL 20101101 NDA NDA021419 SHIONOGI INC. METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 59630-755_d3155034-a311-4bc6-bfc2-ddca30d178cb 59630-755 HUMAN PRESCRIPTION DRUG Methylin Methylphenidate Hydrochloride SOLUTION ORAL 20101101 NDA NDA021419 SHIONOGI INC. METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 59630-777_00ea44c7-97e5-426f-b0f2-8884e8bfa7dc 59630-777 HUMAN PRESCRIPTION DRUG Naprelan Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960401 NDA NDA020353 Shionogi Inc. NAPROXEN SODIUM 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 59630-820_d1672f05-b1ee-40f9-9b4c-7ba2fad264fc 59630-820 HUMAN PRESCRIPTION DRUG Cedax Ceftibuten dihydrate CAPSULE ORAL 19951220 NDA NDA050685 Sciele Pharma, Inc. CEFTIBUTEN DIHYDRATE 400 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 59630-821_d1672f05-b1ee-40f9-9b4c-7ba2fad264fc 59630-821 HUMAN PRESCRIPTION DRUG Cedax Ceftibuten dihydrate SUSPENSION ORAL 19951220 NDA NDA050686 Sciele Pharma, Inc. CEFTIBUTEN DIHYDRATE 18 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 59630-850_00ea44c7-97e5-426f-b0f2-8884e8bfa7dc 59630-850 HUMAN PRESCRIPTION DRUG Naprelan Naproxen Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960401 NDA NDA020353 Shionogi Inc. NAPROXEN SODIUM 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 59630-911_c17c5f9b-778f-4413-80e4-49fcb9e171c2 59630-911 HUMAN PRESCRIPTION DRUG Xodol hydrocodone bitartrate and acetaminophen TABLET ORAL 20111010 ANDA ANDA040658 Shionogi Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 59630-912_c17c5f9b-778f-4413-80e4-49fcb9e171c2 59630-912 HUMAN PRESCRIPTION DRUG Xodol hydrocodone bitartrate and acetaminophen TABLET ORAL 20111010 ANDA ANDA040658 Shionogi Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 59630-913_c17c5f9b-778f-4413-80e4-49fcb9e171c2 59630-913 HUMAN PRESCRIPTION DRUG Xodol hydrocodone bitartrate and acetaminophen TABLET ORAL 20111010 ANDA ANDA040658 Shionogi Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 59630-950_5bece467-967d-4334-a814-d4035e5b6af4 59630-950 HUMAN PRESCRIPTION DRUG Fexmid Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20111001 ANDA ANDA071611 Shionogi Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 59647-243_b58382a3-61b3-4e59-930a-a59ef0960199 59647-243 HUMAN OTC DRUG MED NAP CLEANSING BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130909 OTC MONOGRAPH NOT FINAL part333E Med-Nap LLC BENZALKONIUM CHLORIDE 1.3 mg/1.7mL N 20181231 59647-244_0c9f94fc-958c-40d2-b6db-a544b1ba9bae 59647-244 HUMAN OTC DRUG MED NAP OBSTETRICAL BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130909 OTC MONOGRAPH NOT FINAL part333E Med-Nap LLC BENZALKONIUM CHLORIDE 1.3 mg/1.7mL N 20181231 59647-245_faba983e-59aa-48ea-94ac-d7f06cb34789 59647-245 HUMAN OTC DRUG MED NAP BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130909 OTC MONOGRAPH NOT FINAL part333E Med-Nap LLC BENZALKONIUM CHLORIDE 1.3 mg/1.7mL N 20181231 59647-748_58e348f8-29fb-45d4-8a90-dd3cc329e04b 59647-748 HUMAN OTC DRUG NORTHSIDE HOSPITAL Hand Sanitizing BENZALKONIUM CHLORIDE LIQUID TOPICAL 20170705 OTC MONOGRAPH NOT FINAL part333A Med-Nap LLC BENZALKONIUM CHLORIDE 1.3 mg/1.7mL N 20181231 59647-749_a55a0453-d5ce-4d13-95d5-92ac11258e38 59647-749 HUMAN OTC DRUG Savannah Antiseptic BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part333E Med-Nap LLC BENZALKONIUM CHLORIDE 1.3 mg/1.4g N 20181231 59647-750_fe56a861-0b70-455e-8aa8-b39377cf3934 59647-750 HUMAN OTC DRUG ANTISEPTIC TOWELETTE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160215 OTC MONOGRAPH NOT FINAL part333A Med-Nap LLC BENZALKONIUM CHLORIDE 1.1 mg/1.4mL N 20181231 59651-001_1201712e-f2bb-4f69-abcb-7ce84d6fd28f 59651-001 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150819 ANDA ANDA203270 Aurobindo Pharma Limited OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 59651-002_1201712e-f2bb-4f69-abcb-7ce84d6fd28f 59651-002 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150819 ANDA ANDA203270 Aurobindo Pharma Limited OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 59651-003_1201712e-f2bb-4f69-abcb-7ce84d6fd28f 59651-003 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150819 ANDA ANDA203270 Aurobindo Pharma Limited OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 59651-012_1de8006b-6b11-46a8-b8e8-c6c07b9c9555 59651-012 HUMAN PRESCRIPTION DRUG Eptifibatide Eptifibatide INJECTION INTRAVENOUS 20151208 ANDA ANDA206127 Aurobindo Pharma Limited EPTIFIBATIDE 75 mg/100mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 59651-013_1de8006b-6b11-46a8-b8e8-c6c07b9c9555 59651-013 HUMAN PRESCRIPTION DRUG Eptifibatide Eptifibatide INJECTION INTRAVENOUS 20151208 ANDA ANDA206127 Aurobindo Pharma Limited EPTIFIBATIDE 20 mg/10mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 59651-014_1de8006b-6b11-46a8-b8e8-c6c07b9c9555 59651-014 HUMAN PRESCRIPTION DRUG Eptifibatide Eptifibatide INJECTION INTRAVENOUS 20151208 ANDA ANDA206127 Aurobindo Pharma Limited EPTIFIBATIDE 200 mg/100mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 59651-018_43233a21-3f90-4c69-bbeb-f50d5f2d35ae 59651-018 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20180201 ANDA ANDA209236 Aurobindo Pharma Limited NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20191231 59651-019_43233a21-3f90-4c69-bbeb-f50d5f2d35ae 59651-019 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20180201 ANDA ANDA209236 Aurobindo Pharma Limited NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20191231 59651-020_43233a21-3f90-4c69-bbeb-f50d5f2d35ae 59651-020 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20180201 ANDA ANDA209236 Aurobindo Pharma Limited NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20191231 59651-047_a9e49988-a2cc-410e-9142-146bca539eb4 59651-047 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20160803 NDA AUTHORIZED GENERIC NDA021875 Aurobindo Pharma Limited ARMODAFINIL 200 mg/1 CIV N 20181231 59651-052_726b1e63-437a-4b3b-b773-3ac47a5c0f38 59651-052 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20170825 ANDA ANDA209838 Aurobindo Pharma Limited EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 59651-115_9150b2c4-dac5-4a93-a163-b0cda9082bf3 59651-115 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20170412 ANDA ANDA206206 Aurobindo Pharma Limited ROCURONIUM BROMIDE 50 mg/5mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 59651-116_9150b2c4-dac5-4a93-a163-b0cda9082bf3 59651-116 HUMAN PRESCRIPTION DRUG Rocuronium Bromide Rocuronium Bromide INJECTION, SOLUTION INTRAVENOUS 20170412 ANDA ANDA206206 Aurobindo Pharma Limited ROCURONIUM BROMIDE 100 mg/10mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 59663-001_887b89ab-92bf-4bfa-b6b3-73539f94255c 59663-001 HUMAN OTC DRUG MOISTURIZING SUNSCREEN SPF15 OXYBENZONE LOTION TOPICAL 19960202 OTC MONOGRAPH NOT FINAL part352 Shine & Pretty (USA), Corp. OXYBENZONE; OCTINOXATE 1; 1 mL/100mL; mL/200mL E 20171231 59663-100_9cec24b1-f49f-426e-aba4-5c964231b908 59663-100 HUMAN OTC DRUG ROCK SAUCE METHYL SALICYLATE, MENTHOL, CAPSICUM LOTION TOPICAL 20120602 OTC MONOGRAPH NOT FINAL part348 Shine & Pretty (USA), Corp. METHYL SALICYLATE; MENTHOL; CAPSICUM 20; 10; .05 mL/100mL; mL/100mL; mL/100mL E 20171231 59663-100_f5cf2d9b-ccf4-4ae9-b470-b384e19e8650 59663-100 HUMAN OTC DRUG ROCK SAUCE METHYL SALICYLATE, MENTHOL, CAPSICUM LOTION TOPICAL 20120413 OTC MONOGRAPH NOT FINAL part348 Shine & Pretty (USA), Corp. METHYL SALICYLATE; MENTHOL; CAPSICUM 20; 10; .05 mL/100mL; mL/100mL; mL/100mL E 20171231 59663-110_37ca5bcc-de29-4713-b17e-2cd0b963056a 59663-110 HUMAN OTC DRUG Solar Defender SPF 30 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20130201 OTC MONOGRAPH NOT FINAL part352 Shine & Pretty (USA), Corp. OCTINOXATE; ZINC OXIDE 75; 100 mg/mL; mg/mL E 20171231 59663-120_f14a4df5-50ee-4760-ae90-b4c722922586 59663-120 HUMAN OTC DRUG Planet Sun SPF 30 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Shine & Pretty (USA), Corp. OCTINOXATE; ZINC OXIDE 75; 100 mg/mL; mg/mL E 20171231 59663-130_cd387d64-c499-403f-a819-c7a80983a566 59663-130 HUMAN OTC DRUG Epicuren Discovery SPF 30 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Shine & Pretty (USA), Corp. OCTINOXATE; ZINC OXIDE 75; 100 mg/mL; mg/mL E 20171231 59663-140_2833baa3-9855-4573-8fc2-239eefa72a52 59663-140 HUMAN OTC DRUG Bella Pelle SPF 30 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Shine & Pretty (USA), Corp. OCTINOXATE; ZINC OXIDE 75; 100 mg/mL; mg/mL E 20171231 59667-0001_a407937f-320d-4ed4-8582-efe2a4e7f9b7 59667-0001 HUMAN OTC DRUG Abundant Milk Aconite, Agnus Castus, Alfalfa, Asafeotida, Calcarea Carb, Chamomilla, Causticum, Dulcamara, Lac Caninum, Lactuca Virosa, Phosphoricum Acidum, Pulsatilla, Ricinus, Rhus Tox, Silicea, Sulphur, Thyroidinum, Urtica Urens, Zinc SPRAY ORAL 20130801 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; CHASTE TREE; ALFALFA; ASAFETIDA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; CAUSTICUM; SOLANUM DULCAMARA TOP; CANIS LUPUS FAMILIARIS MILK; LACTUCA VIROSA; PHOSPHORIC ACID; PULSATILLA VULGARIS; RICINUS COMMUNIS WHOLE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; THYROID, UNSPECIFIED; URTICA URENS; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0002_07da46df-30c7-4944-b2ca-867a60dab300 59667-0002 HUMAN OTC DRUG Thrush Nipples Baptisia, Bryonia, Borax, Candida A, Calendula, Hydrastis, Kali Chloricum, Mercurius Sol, Nat Mur, Nux Moschata, Nux Vomica, Phosphorus, Saccharum Album, Sulphuricum Acidum, Staphysagria, SPRAY ORAL 20130805 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; SODIUM BORATE; CANDIDA ALBICANS; CALENDULA OFFICINALIS FLOWERING TOP; GOLDENSEAL; POTASSIUM CHLORATE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; NUTMEG; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SUCROSE; SULFURIC ACID; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0003_5c46cb33-ccab-44a9-8b8e-d0cda5f99bde 59667-0003 HUMAN OTC DRUG Abundant Milk 2 Belladonna, Bryonia, Chelidonium, Cinchona Officionalis, Coffea Cruda, Ignatia, Formalinum, Lac Defloratum, Lac Vaccini Flos, Lecithinum, Phosphorus, Phytolacca, Secale, SPRAY ORAL 20130815 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ATROPA BELLADONNA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; FORMALDEHYDE; SKIM MILK; COW MILK FAT; EGG PHOSPHOLIPIDS; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; CLAVICEPS PURPUREA SCLEROTIUM 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0010_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0010 HUMAN OTC DRUG Tummy Aches and Gas Arsenicum Album, Carbo Veg, Colocynthis, Chamomilla, Dioscorea, Ipecac, Mag. Phos, Sulphur SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC ACID; ACTIVATED CHARCOAL; CITRULLUS COLOCYNTHIS FRUIT PULP; MATRICARIA RECUTITA; DIOSCOREA VILLOSA TUBER; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SULFUR 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0011_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0011 HUMAN OTC DRUG UTI and Kidney Stones Apis, Berberis Vulgaris, Bryonia, Cantharis, Staphysaria, Sarsaparilla, Urtica Urens SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; SARSAPARILLA; DELPHINIUM STAPHISAGRIA SEED; URTICA URENS 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0012_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0012 HUMAN OTC DRUG Nausea, Vomiting and Diarrhea Arsenicum Album, Bryonia, Cinchona, Colocynthis, Ipecac, Nux Vomica, Phosphorous, Veratrum Album SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC ACID; BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0013_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0013 HUMAN OTC DRUG Bug Bites and Stings Aconite, Apis, Cantharis, Carbolicum Acidum, Hypericum, Lachesis, Ledum, Staphysagria, Urtica Urens SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; APIS MELLIFERA; LYTTA VESICATORIA; PHENOL; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; DELPHINIUM STAPHISAGRIA SEED; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0014_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0014 HUMAN OTC DRUG Infected Cuts and Punctures Arnica, Apis, Hepar Sulph, Hypericum, Ledum, Silicea SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; APIS MELLIFERA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; SILICON DIOXIDE 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0015_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0015 HUMAN OTC DRUG Cuts and Scrapes Aconite, Arnica, Calendula, Hypericum, Silicea SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; SILICON DIOXIDE 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0016_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0016 HUMAN OTC DRUG Burns Arnica, Cantharis, Calendula, Causticum, Hypericum, Urtica Urens SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; LYTTA VESICATORIA; CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; HYPERICUM PERFORATUM; URTICA URENS 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0017_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0017 HUMAN OTC DRUG Blunt Trauma Aconite, Arnica, Calendula, Hypericum, Ledum, Ruta Grav. SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0018_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0018 HUMAN OTC DRUG Head Injury conite, Arnica, Belladonna, Badiaga, Helleborus, Hypericum Nat Sulph SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; SPONGILLA LACUSTRIS; HELLEBORUS NIGER ROOT; HYPERICUM PERFORATUM; SODIUM SULFATE 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0019_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0019 HUMAN OTC DRUG Sprains, Strains and Fractures Aconite, Arnica, Calcarea Carb. Calcarea Phosphorica, Carbolicum Acidum, Hepar Sulph, Hypericum, Rhus Tox, Ruta Graveolens, Symphytum SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFIDE; PHENOL; HYPERICUM PERFORATUM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0020_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0020 HUMAN OTC DRUG Mild Earaches and Teething Aconite, Belladonna, Chamomilla, Ferrum Phosphorica, Hepar Sulph, Plantago, Pulsatilla SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ATROPA BELLADONNA; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0021_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0021 HUMAN OTC DRUG Eye Injuries and Infections Aconite, Arnica, Belladonna, Euphrasia, Gelsemium, Hypericum, Rhus Tox, Symphytum SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; TOXICODENDRON PUBESCENS LEAF; COMFREY ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0022_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0022 HUMAN OTC DRUG Headaches Arnica, Apis, Bryonia, Belladonna, Gelsemium, Lachesis, Lycopodium, Magnesia Phosphorica, Natrum Muriaticum SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; APIS MELLIFERA; BRYONIA ALBA ROOT; ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0023_7c13d9c1-c0ef-4b34-af0c-ac7acc44510f 59667-0023 HUMAN OTC DRUG Toothaches and Abscess Arnica, Belladonna, Calcarea Phosphorica, Chamomilla, Hepar Sulph, Hypericum, Mercurius SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; MERCURY 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0024_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0024 HUMAN OTC DRUG Migraines Asafeotida 30c, Cannabis Indica 30c, Cannabis Sativa 30c, Coffea Cruda 30c, Helleborus 30c, Ipecac 30c, Iris 30c, Lac Caninum 30c, Mentha Piperita 30c, Natrum Sulph 30c, Oleum Animalis 30c, Opium 30c, Phosphoricum Acidum 30c, Psorinum 30c, Sanguinaria 30c, Senecio 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ASAFETIDA; CANNABIS SATIVA SUBSP. INDICA TOP; CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; HELLEBORUS FOETIDUS ROOT; IPECAC; IRIS VERSICOLOR ROOT; CANIS LUPUS FAMILIARIS MILK; MENTHA PIPERITA; SODIUM SULFATE; CERVUS ELAPHUS HORN OIL; OPIUM; PHOSPHORIC ACID; SCABIES LESION LYSATE (HUMAN); SANGUINARIA CANADENSIS ROOT; SENECIO VULGARIS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0025_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0025 HUMAN OTC DRUG Sinus Headaches and Infections Calc Sulph 30c, Dulcamara 30c, Euphrasia 30c, Gelsemium 30c, Graphites 30c, Hepar Sulph 30c, Hydrastis 30c, Kali Bich 30c, Kali Iodatum 30c, Lycopodium 30c, Medorrhinum 30c, Mercurius Sol 30c, Nux Vomica 30c, Pulsatilla 30c, Silicea 30c, Thuja 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CALCIUM SULFATE; SOLANUM DULCAMARA TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; CALCIUM SULFIDE; HYDRASTIS CANADENSIS WHOLE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM WHOLE; GONORRHEAL URETHRAL SECRETION HUMAN; MERCURIUS SOLUBILIS; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0026_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0026 HUMAN OTC DRUG Fever and Flu Aconite 30c, Arsenicum 30c, Baptisia 30c, Belladonna 30c, Bryonia 30c, Chelidonium 30c, Eupatorium 30c, Ferrum Phos 30c, Gelsemium 30c, Influenzinum 30c, Naja 30c, Nux Vomica 30c, Oscillo 30c, Phosphorous 30c, SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARSENIC ACID; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; NAJA NAJA VENOM; STRYCHNOS NUX-VOMICA SEED; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; PHOSPHORUS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0027_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0027 HUMAN OTC DRUG Cough and Cold Aconite 30c, Belladonna 30c, Ferrum Phos 30c, Pulsatilla 30c, Spongia 30c, Rumex Crispus 30c, Mercurius 30c, Wyethia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ATROPA BELLADONNA; FERRUM PHOSPHORICUM; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED; RUMEX CRISPUS ROOT; MERCURY; WYETHIA HELENIOIDES ROOT 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0028_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0028 HUMAN OTC DRUG Nagging Cough Carbo Veg 30c, Cuprum Metalicum 30c, Mercurius Sol 30c, Phosphorous 30c, Pulsatilla 30c, Stannum Met 30c, Veratrum Album 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACTIVATED CHARCOAL; COPPER; MERCURIUS SOLUBILIS; PHOSPHORUS; PULSATILLA VULGARIS; TIN; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0029_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0029 HUMAN OTC DRUG Croup Aconite 30c, Antimonium Tart 30c, Belladonna 30c, Bromium 30c, Bryonia 30c, Calc Sulph 30c, Drosera 30c, Dulcmara 30c, Hepar Sulph 30c, Iodium 30c, Kali Bich 30c, Lachesis 30c, Nitricum Acidum 30c, Phosphorous 30c, Phytolacca 30c, Sambucus 30c, Spongia 30c, Stramonium SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BROMINE; BRYONIA ALBA ROOT; CALCIUM SULFATE; DROSERA ROTUNDIFOLIA; SOLANUM DULCAMARA TOP; CALCIUM SULFIDE; IODINE; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SAMBUCUS CANADENSIS FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED; DATURA STRAMONIUM 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0030_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0030 HUMAN OTC DRUG Allergic Attack Adrenalinum 30c, Apis 30c, Arsenicum 30c, Cat Hair 30c, Cicuta Virosa 30c, House Dust 30c, House Dust Mites 30c, Human Dandruff 30c, Histuminum 6c, Histaminum 200c, Nat Mur 30c, Mixed Pollens 30c, Rhus Tox 30c, Urtica Urens 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics EPINEPHRINE; APIS MELLIFERA VENOM; ARSENIC ACID; FELIS CATUS DANDER; CICUTA VIROSA WHOLE; HOUSE DUST; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; HUMAN DANDER; HISTAMINE DIHYDROCHLORIDE; SODIUM CHLORIDE; AGROSTIS CAPILLARIS POLLEN; ALOPECURUS PRATENSIS POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARRHENATHERUM ELATIUS POLLEN; BROMUS COMMUTATUS POLLEN; CYNOSURUS CRISTATUS POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; HOLCUS LANATUS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; ALNUS GLUTINOSA POLLEN; BETULA PENDULA POLLEN; CORYLUS AVELLANA POLLEN; FAGUS SYLVATICA POLLEN; FRAXINUS EXCELSIOR POLLEN; PLATANUS X ACERIFOLIA POLLEN; POPULUS TREMULA POLLEN; QUERCUS ROBUR POLLEN; SALIX ALBA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ARTEMISIA VULGARIS POLLEN; BRASSICA NAPUS SUBSP. NAPUS POLLEN; CALLUNA VULGARIS POLLEN; CHENOPODIUM BONUS-HENRICUS POLLEN; PLANTAGO MAJOR POLLEN; RANUNCULUS BULBOSUS POLLEN; URTICA DIOICA POLLEN; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0031_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0031 HUMAN OTC DRUG Food Sensitivities Apis 30c, Arsenicum 30c, Baptisia 30c, Caseinum 30c, Colocynthis 30c, Corn 30c, Food Dye Additives 30c, Food Preservatives 30c, Histaminum 30c, Hyoscyamus 30c, Mixed Nuts 30c, Modified Corn Starch 30c, MSG 30c, Natrum Mur 30c, Phosphorous 30c, Sacharrin 30c, Soy 30c, Strawberry 30c, Uritca Urens 30c, Wheat Gluten 30c, Whole Egg 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics APIS MELLIFERA VENOM; ARSENIC ACID; BAPTISIA TINCTORIA; CASEIN; CITRULLUS COLOCYNTHIS FRUIT PULP; CORN; FD&C YELLOW NO. 5; D&C YELLOW NO. 11; AMARANTH; FD&C YELLOW NO. 6; SODIUM NITRITE; SODIUM BENZOATE; PROPYLPARABEN; METHYLPARABEN; HISTAMINE DIHYDROCHLORIDE; HYOSCYAMUS NIGER; PEANUT; ENGLISH WALNUT; ALMOND; MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE); MONOSODIUM GLUTAMATE; SODIUM CHLORIDE; PHOSPHORUS; SACCHARIN; SOYBEAN; STRAWBERRY; URTICA URENS; WHEAT GLUTEN; EGG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0032_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0032 HUMAN OTC DRUG Hay Fever Allium Cepa 30c, Arsenicum Iod. 30c, Euphrasia 30c, Gelsemium 30c, Dulcamara 30c, Kali Bich 30c, Sticta 30c, Sabadilla 30c, Wyethia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALLIUM CEPA WHOLE; ARSENIC TRIIODIDE; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; SOLANUM DULCAMARA TOP; POTASSIUM DICHROMATE; LOBARIA PULMONARIA; SCHOENOCAULON OFFICINALE SEED; WYETHIA HELENIOIDES ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0033_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0033 HUMAN OTC DRUG Constipation Aloe 30c, Alumina 30c, Arsenicum 30c, Nux Vomica 30c, Calc Carb 30c, Opium 30c, Plumbum 30c, Podophyllum 30c, Pyrethrum 30c, Silicea 30c, Staphysagria 30c, Rheum 30c, Urtica Urens 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALOE; ALUMINUM OXIDE; ARSENIC ACID; CALCIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; OPIUM; LEAD; PODOPHYLLUM; TANACETUM PARTHENIUM; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; RHEUM OFFICINALE ROOT; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0034_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0034 HUMAN OTC DRUG Chillax Aconite 30c, Arsenicum 30c, Bambusa 30c, Baryta Carb 30c, Calc Carb 30c, Calc Phos 30c, Hyoscyamus 30c, Ignatia 30c, Lilium Tig 30c, Lycopodium 30c, Mag Mur 30c, Nat Mur 30c,Nat Sulph 30c, Nux Vomica 30c, Phosphorous 30c, Sepia 30c, Silicea 30c, Staphysagria 30c, Stramonium SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARSENIC ACID; BAMBUSA BAMBOS WHOLE; BARIUM CARBONATE; CALCIUM CARBONATE; CALCIUM PHOSPHATE; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0035_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0035 HUMAN OTC DRUG Back Strain and Injury Arnica 30c, Berberis Vulgaris 30c, Bryonia 30c, Graphites 30c, Hypericum 30c, Kali Carb 30c, Lycopodium 30c, Nat Sulph 30c, Rhus Tox 30c, Ruta Grav 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; GRAPHITE; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0036_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0036 HUMAN OTC DRUG Reflux and Heartburn Arsenicum 30c, Bryonia 30c, Carbo Animalis 30c, Carbo Veg 30c, Nat Phos 30c, Nux Vomica 30c, Mag Phos 30c, Pulsatilla 30c, Sepia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC ACID; BRYONIA ALBA ROOT; CARBO ANIMALIS; ACTIVATED CHARCOAL; SODIUM PHOSPHATE; STRYCHNOS NUX-VOMICA SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0037_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0037 HUMAN OTC DRUG Rashes and Hives Anacardium 30c, Apis 30c, Arsenicum 30c, 30c, Astacus 30c, Calc Carb 30c, Calc Sulph 30c, Carboneum Sulph 30c, Causticum 30c, Chloralum 30c, Copaifera 30c, Cortisonum 30c, Dulcamara 30c, Hepar Sulph 30c, Ledum 30c, Nat Mur 30c, Rhus Tox 30c, Sulphur 30c, Uritca Urens 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANACARDIUM OCCIDENTALE FRUIT; APIS MELLIFERA VENOM; ARSENIC ACID; ASTACUS ASTACUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM SULFATE ANHYDROUS; CARBON DISULFIDE; CAUSTICUM; CHLORAL HYDRATE; COPAIFERA OFFICINALIS RESIN; CORTISONE ACETATE; SOLANUM DULCAMARA TOP; CALCIUM SULFIDE; LEDUM PALUSTRE TWIG; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF; SULFUR; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0038_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0038 HUMAN OTC DRUG Stiff Joints Arsenicum 30c, Bryonia 30c, Carbo Animalis 30c, Caulophyllum 30c, Causticum 30c, Cocculus 30c, Colchicum 30c, Guaiacum 30c, Ledum 30c, Lycopodium 30c, Petroleum 30c, Rhus Tox 30c, Sepia 30c, Silicea 30c, Sulphur SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC ACID; BRYONIA ALBA ROOT; CARBO ANIMALIS; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; KEROSENE; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0039_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0039 HUMAN OTC DRUG Joint Pain Anacardium 30c, Argentum Muriaticum 30c, Arnica 30c, Aurum Met 30c, Bryonia 30c, Calc Phos. 30c, Capsicum 30c, Causticum 30c, Euphrasia 30c, Hydrofluoricum Acidum 30c, Nitricum Acidum 30c, Nux Vomica 30c, Plumbum Met. 30c, Rhus Tox 30c, Ruta Grav 30c, Staphysagria 30c, Valeriana 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANACARDIUM OCCIDENTALE FRUIT; SILVER CHLORIDE; ARNICA MONTANA; GOLD; BRYONIA ALBA ROOT; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; CAPSICUM; CAUSTICUM; EUPHRASIA STRICTA; HYDROFLUORIC ACID; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; LEAD; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0040_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0040 HUMAN OTC DRUG Early Menopause Absinthium 30c, Aurum Met. 30c, Bambusa 30c, Baryta Carb 30c, Baryta Mur 30c, Carboneum Sulph 30c, Conium 30c, Dulcamara 30c, Euphrasia 30c, Ferrum Iodatum 30c, Graphites 30c, Ignatia 30c, Iodium 30c, Kali Carb 30c, Lycopodium 30c, Pulsatilla 30c, Senecio 30c, Sepia 30c, Silicea 30c, Sabal 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics WORMWOOD; GOLD; BAMBUSA BAMBOS WHOLE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; CARBON DISULFIDE; CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; EUPHRASIA STRICTA; FERROUS IODIDE; GRAPHITE; STRYCHNOS IGNATII SEED; IODINE; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SAW PALMETTO; SILICON DIOXIDE; PACKERA AUREA; SEPIA OFFICINALIS JUICE; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0041_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0041 HUMAN OTC DRUG Healing After Surgery Aceticum Acidum 30c, Aconite 30c, Arnica 30c, Allium Cepa 30c, Belladonna 30c, Calendula 30c, Hepar Sulph 30c, Hypericum 30c, Phosphorous 30c, Pyrogenium 30c, Silicea 30c, Staphysagria SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACETIC ACID; ACONITUM NAPELLUS; ARNICA MONTANA; ALLIUM CEPA WHOLE; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CALCIUM SULFIDE; HYPERICUM PERFORATUM; PHOSPHORUS; RANCID BEEF; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0042_686d297a-422b-4e7e-b669-cdb21a64ffa3 59667-0042 HUMAN OTC DRUG Severe Back Pain Arsenicum 30c, Belladonna 30c, Bryonia 30c, Carbo Animalis 30c, Cinchona 30c, Cina 30c, Colocynthis 30c, Graphites 30c, Ignatia 30c, Lycopodium 30c, Nat Mur 30c, Nitricum Acidum 30c, Rhus Tox SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC ACID; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CARBO ANIMALIS; CINCHONA OFFICINALIS BARK; ARTEMISIA CINA PRE-FLOWERING TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; GRAPHITE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; NITRIC ACID; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0043_447b865d-8489-4580-b712-73e016fea921 59667-0043 HUMAN OTC DRUG Nausea and Vomiting aconite 30c, arsenicum album 30c, asarum 30c, conium mac 30c, ipecac 30c, kreosotum 30c, lacticum acidum 30c, medorrhinum 30c, nat mur 30c, nux moschata 30c, nux vomica 30c, phosphorus 30c, pulsatilla 30c, sepia 30c, tobacum 30c, nicotinum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARSENIC ACID; ASARUM CANADENSE ROOT; CONIUM MACULATUM FLOWERING TOP; IPECAC; WOOD CREOSOTE; LACTIC ACID, DL-; GONORRHEAL URETHRAL SECRETION HUMAN; SODIUM CHLORIDE; NUTMEG; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; TOBACCO LEAF; NICOTINE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0044_447b865d-8489-4580-b712-73e016fea921 59667-0044 HUMAN OTC DRUG Water Retention and High BP Apis, Arsenicum, Crotalis Hor 30c, Digitalis 30c, Helonias 30c, Kali Chlor 30c,, Lachesis 30c, Lycopodium 30c, Mercurius Corr. 30c, Nat Mur30c, Phosphorus 30c, Veratrum Vir 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics APIS MELLIFERA VENOM; ARSENIC ACID; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; CHAMAELIRIUM LUTEUM ROOT; POTASSIUM CHLORATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM CHLORIDE; PHOSPHORUS; VERATRUM VIRIDE ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0045_447b865d-8489-4580-b712-73e016fea921 59667-0045 HUMAN OTC DRUG Breech Baby Ignatia 30c, Nat Mur 30c, Pulsatilla 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; PULSATILLA VULGARIS 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0046_447b865d-8489-4580-b712-73e016fea921 59667-0046 HUMAN OTC DRUG Back Labor Cimicifuga 30c, Coffea Cruda 30c, Causticum 30c, Kali Carb 30c, Nux Vomica 30c Petroleum 30c, Sepia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics BLACK COHOSH; ARABICA COFFEE BEAN; CAUSTICUM; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PETROLATUM; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0047_447b865d-8489-4580-b712-73e016fea921 59667-0047 HUMAN OTC DRUG Labor Exhaustion Arnica 30c, Belladonna 30c, Carbo Veg 30c, Caulophyllum 30c, Cimicifuga 30c, Gelsemium 30c, Kali Carb 30c, Kali Phos 30c , Nat Mur 30c, Opium 30c, Pulsatilla 30c, Secale 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; ATROPA BELLADONNA; ACTIVATED CHARCOAL; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; CLAVICEPS PURPUREA SCLEROTIUM; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0048_447b865d-8489-4580-b712-73e016fea921 59667-0048 HUMAN OTC DRUG PPH Prevention Arnica, Bellis SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; BELLIS PERENNIS 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0049_447b865d-8489-4580-b712-73e016fea921 59667-0049 HUMAN OTC DRUG PPH Cinchona, Cinnamomum SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CINCHONA OFFICINALIS BARK; CINNAMON 30; 200 [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0050_447b865d-8489-4580-b712-73e016fea921 59667-0050 HUMAN OTC DRUG Baby Respiration Aconite, Antimonium Tart , Arnica , Carbo Veg SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; ACTIVATED CHARCOAL 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0051_447b865d-8489-4580-b712-73e016fea921 59667-0051 HUMAN OTC DRUG After Pains and Tears Arnica 30c, Apis 30c, Belladonna 30c, Calendula 30c, Caulophyllum 30c, Chamomilla 30c, Cimicifuga 30c, Ferrum Met. 30c, Kali Carb 30c, Sabina 30c, Secale 30c, Viburnum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; APIS MELLIFERA VENOM; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0052_447b865d-8489-4580-b712-73e016fea921 59667-0052 HUMAN OTC DRUG Postpartum Issues Agnus Castus 30c, Cimicifuga 30c, Nat Mur 30c, Platina 30c, Pulsatilla 30c, Sepia 30c, Sulphur 30c, Tarentula 30c Veratrum Vir 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CHASTE TREE; BLACK COHOSH; SODIUM CHLORIDE; PLATINUM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SULFUR; LYCOSA TARANTULA; VERATRUM VIRIDE ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0053_447b865d-8489-4580-b712-73e016fea921 59667-0053 HUMAN OTC DRUG Infection Arnica 30c, Hepar Sulph 30c, Kali Mur 30c, Silicea SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; CALCIUM SULFIDE; POTASSIUM CHLORIDE; SILICON DIOXIDE 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0054_447b865d-8489-4580-b712-73e016fea921 59667-0054 HUMAN OTC DRUG Low Iron Calcarea Phos. Cinchona, Ferrum Phos, Nat Mur SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CINCHONA OFFICINALIS BARK; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE; ANHYDROUS DIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0055_447b865d-8489-4580-b712-73e016fea921 59667-0055 HUMAN OTC DRUG Loss, Grief and Depression Aurum 30c, Ignatia 30c, Nat Mur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics GOLD; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0056_447b865d-8489-4580-b712-73e016fea921 59667-0056 HUMAN OTC DRUG Boob Ease Belladonna 30c, Bryonia 30c, Calendula 30c, Chamomilla 30c, Colchicum 30c, Graphites 30c, Hepar Sulph 30c, Phytolacca 30c Pulsatilla 30c, Silicea 30c, Urtica Urens SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; COLCHICUM AUTUMNALE SEED; GRAPHITE; CALCIUM SULFIDE; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SILICON DIOXIDE; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0057_447b865d-8489-4580-b712-73e016fea921 59667-0057 HUMAN OTC DRUG Bfing Aversion Arnica 30c, Aurum Nat Mur 30c, Bambusa 30c, Calc phos, Chamomilla 30c, Kali Bromatum 30c, Lilium Tig 30c, Nitricum Acidum 30c, Secale 30c, Silicea 30c, Sepia 30c, Phosphorous 30c, Platina 30 SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; SODIUM TETRACHLOROAURATE; BAMBUSA BAMBOS WHOLE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; MATRICARIA RECUTITA; POTASSIUM BROMIDE; LILIUM LANCIFOLIUM WHOLE FLOWERING; NITRIC ACID; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; PHOSPHORUS; PLATINUM 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0058_447b865d-8489-4580-b712-73e016fea921 59667-0058 HUMAN OTC DRUG Sore Nipples Arnica 30c, Borax 30c Calc Carb 30c, Calendula 30c, Castor Eq 30c, Chamomilla 30c, Croton Tig 30c, Hamamelis 30c, Helonias 30c, Ignatia 30c, Merc Cor 30c, Nux Vomica 30c, Phytolacca 30c, Pulsatilla 30c, Ratanhia 30c, Silicea 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALENDULA OFFICINALIS FLOWERING TOP; CASTOR OIL; MATRICARIA RECUTITA; CROTON TIGLIUM SEED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS IGNATII SEED; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0059_447b865d-8489-4580-b712-73e016fea921 59667-0059 HUMAN OTC DRUG Yummy Mummy Milk Aethusa 30c, Antimonium Crudum 30c, Calcarea Carb 30c, Calcarea Phos 30c, Chamomilla 30c, Ferrum Phos 30c, Kali Bich 30c, Natrum Carb 30c, Phosphoricum Acidum 30c, Rheum 30c, Silicea 30c, Valeriana 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; CALCIUM SULFIDE; HYPERICUM PERFORATUM; MERCURY 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0060_e453932f-7a53-4732-81fd-f053440be1aa 59667-0060 HUMAN OTC DRUG Menstrual Cramps Back Ammonium Carb 30c, Borax 30c, Calcarea Phosphorica 30c, Chamomilla 30c, Cimicifuga 30c, Gelsemium 30c, Helonius 30c, Kali Carb 30c, Nux Vomica 30c Pulsatilla 30c, Senecio 30c, Xanthum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics AMMONIUM CARBONATE; SODIUM BORATE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; CHAMAELIRIUM LUTEUM ROOT; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; PACKERA AUREA; ZANTHOXYLUM AMERICANUM BARK 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0061_e453932f-7a53-4732-81fd-f053440be1aa 59667-0061 HUMAN OTC DRUG Menstrual Cramps Front Ammonium Mur 30c, Belladonna 30c, Cactus 30c, Caladium 30c, Calc Phos 30c, Caulophyllum 30c, Chamomilla 30c, Cocculus 30c, Conium 30c, Gelsemium 30c, Ignatia 30c, Mag Mur 30c, Nux Vomica 30c, Platina 30c, Sepia 30c Tarentula 30c, Viburnum 30c, Ustillago 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics AMMONIUM CHLORIDE; ATROPA BELLADONNA; SELENICEREUS GRANDIFLORUS STEM; DIEFFENBACHIA SEGUINE; TRIBASIC CALCIUM PHOSPHATE; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; MAGNESIUM CHLORIDE; PLATINUM; LYCOSA TARANTULA; SEPIA OFFICINALIS JUICE; USTILAGO MAYDIS; VIBURNUM OPULUS BARK 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0062_e453932f-7a53-4732-81fd-f053440be1aa 59667-0062 HUMAN OTC DRUG Scanty Flow Agnus 30c, Argentum Nitricum 30c, Cinchona 30c, Conium 30c, Dioscorea 30c, Gelsemium 30c, Lycopodium 30c, Phosphoricum Acidum 30c, Nux Vomica 30c, Sabal 30c, Seleninum 30c, Staphysagria 30c, Strychninum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CHASTE TREE; SILVER NITRATE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DIOSCOREA VILLOSA TUBER; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; STRYCHNINE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0063_e453932f-7a53-4732-81fd-f053440be1aa 59667-0063 HUMAN OTC DRUG Heavy Flow Aletris 30c, Belladonna 30c, Bovista 30c, Cinchona 30c, Colocynthis 30c, Chamomilla 30c, Cinnamomum 30c, Coffea Cruda 30c, Secale 30c, Veratrum Album 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALETRIS FARINOSA ROOT; ATROPA BELLADONNA; GIANT PUFFBALL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; MATRICARIA RECUTITA; CINNAMON; ARABICA COFFEE BEAN; VERATRUM ALBUM ROOT; CLAVICEPS PURPUREA SCLEROTIUM 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0064_e453932f-7a53-4732-81fd-f053440be1aa 59667-0064 HUMAN OTC DRUG PCOS Apis 30c, Aurum Nat Mur 30c, Calc Fluor 30c, Nat Sulph 30c, Palladium 30c, Silicea 30c, Sabal 30c, Thuja 30c, Ustillago 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics APIS MELLIFERA VENOM; SODIUM TETRACHLOROAURATE; CALCIUM FLUORIDE; SODIUM SULFATE; PALLADIUM; SILICON DIOXIDE; SAW PALMETTO; THUJA OCCIDENTALIS LEAFY TWIG; USTILAGO MAYDIS 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0065_e453932f-7a53-4732-81fd-f053440be1aa 59667-0065 HUMAN OTC DRUG Bloating Bovista 30c, Carbo Veg 30c, Cinchona 30c, Cocculus 30c, Graphites 30c, Kali Carb 30c, Lachesis 30c, Lycopodium 3c, Nat Carb 30c, Pulsatilla 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics GIANT PUFFBALL; ACTIVATED CHARCOAL; CINCHONA OFFICINALIS BARK; ANAMIRTA COCCULUS SEED; GRAPHITE; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; PULSATILLA VULGARIS; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0066_e453932f-7a53-4732-81fd-f053440be1aa 59667-0066 HUMAN OTC DRUG Hormonal Headaches Belladonna 30c, Cinchona 30c, Ferrum Phos 30c, Gelsemium 30c, Glonoine 30, Lachesis 30c, Nat Mur 30c, Nux Vomica 30c, Sanguinaria 30c, Sepia 30c, Sulphur 30c, Tarentula 30c, Ustillago 30c, Veratrum Album 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; LACHESIS MUTA VENOM; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFUR; LYCOSA TARANTULA; USTILAGO MAYDIS; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0067_e453932f-7a53-4732-81fd-f053440be1aa 59667-0067 HUMAN OTC DRUG Tender Breasts Bryonia 30c, Calc Carb 30c, Conium Mac 30c, Helonius 30c, Iodium 30c, Lac Can 30c, Phytolacca 30c, Pulsatilla 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; CHAMAELIRIUM LUTEUM ROOT; IODINE; CANIS LUPUS FAMILIARIS MILK; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0068_e453932f-7a53-4732-81fd-f053440be1aa 59667-0068 HUMAN OTC DRUG Mood Swings Aconite 30c, Belladonna 30c, Chamomilla 30c, Cimicifuga 30c, Ignatia 30c, Lachesis 30c, Pulsatilla 30c, Sepia 30c, Nux Vomica 30c Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS ROOT; ATROPA BELLADONNA; MATRICARIA RECUTITA; BLACK COHOSH; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0069_e453932f-7a53-4732-81fd-f053440be1aa 59667-0069 HUMAN OTC DRUG Baby Dust Agnus C. 30c, Borax 30c, Condurango 30c, Graphites 30c, Iodium 30c, Medorrhinum 30c, Nat Mur 30c, Platina 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CHASTE TREE; SODIUM BORATE; MARSDENIA CONDURANGO BARK; GRAPHITE; IODINE; GONORRHEAL URETHRAL SECRETION HUMAN; SODIUM CHLORIDE; PLATINUM 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0070_e453932f-7a53-4732-81fd-f053440be1aa 59667-0070 HUMAN OTC DRUG Sticky Baby Dust Aconite 30c, Arnica 30c, Belladonna 30c, Baptisia 30c, Chamomilla 30c, Caulophylum 30c, Cinnamomum 30c, Eupatorium 30c, Phosphorous30c, Pulsatilla 30c, Sabina 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; MATRICARIA RECUTITA; CAULOPHYLLUM THALICTROIDES ROOT; CINNAMON; EUPATORIUM PERFOLIATUM FLOWERING TOP; PHOSPHORUS; PULSATILLA VULGARIS; JUNIPERUS SABINA LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0071_e453932f-7a53-4732-81fd-f053440be1aa 59667-0071 HUMAN OTC DRUG Rainbow Baby Aletris 30c, Calc Carb 30c, Cimicifuga 30c, Caulophyllum 30c, Helonius 30c, Kali Carb. 30c, Sabina 30c, Secale 30c, Viburnum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALETRIS FARINOSA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; BLACK COHOSH; CAULOPHYLLUM THALICTROIDES ROOT; CHAMAELIRIUM LUTEUM ROOT; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0072_e453932f-7a53-4732-81fd-f053440be1aa 59667-0072 HUMAN OTC DRUG Ovulation Boost Agnus 30c, Aurum Nat Mur. 30c, Aletris 30c, Dioscorea 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALETRIS FARINOSA ROOT; SODIUM TETRACHLOROAURATE; CHASTE TREE; DIOSCOREA VILLOSA TUBER 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0073_e453932f-7a53-4732-81fd-f053440be1aa 59667-0073 HUMAN OTC DRUG Hot Flashes Belladonna 30c, Calc Phos 30c, Ferrum Phos 30c, Glonoine 30c, Lachesis 30c, Sanguinaria 30c Sepia 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; NITROGLYCERIN; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFUR 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0075_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0075 HUMAN OTC DRUG Tantrums and Whining Arsenicum 30c, Belladonna 30c, Calc Phos 30c, Chamomilla 30c, Cina 30c, Ignatia 30c, Pulsatilla 30c, Nat Mur 30c, Nux Vomica 30c, Thuja 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC ACID; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; ARTEMISIA CINA PRE-FLOWERING TOP; STRYCHNOS IGNATII SEED; PULSATILLA VULGARIS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0076_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0076 HUMAN OTC DRUG Kicking and Screaming Apis 30c, Anacardium 30c, Belladonna 30c, Borax 30c, Calc Phos 30c, Chamomilla 30c, Cina 30c, Ipecac 30c, Kali Carb, Lac Can 30c, Stramoniumn 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics APIS MELLIFERA VENOM; SEMECARPUS ANACARDIUM JUICE; ATROPA BELLADONNA; SODIUM BORATE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; ARTEMISIA CINA PRE-FLOWERING TOP; IPECAC; POTASSIUM CARBONATE; CANIS LUPUS FAMILIARIS MILK; DATURA STRAMONIUM 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0077_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0077 HUMAN OTC DRUG Hair Pulling Arsenicum 30c, Belladonna 30c, Cina 30c, Cuprum 30c, Lillium 30c Tarentula 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC TRIOXIDE; ATROPA BELLADONNA; ARTEMISIA CINA PRE-FLOWERING TOP; COPPER; LILIUM LANCIFOLIUM FLOWERING TOP; LYCOSA TARANTULA 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0078_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0078 HUMAN OTC DRUG Pinching and Biting Belladonna 30c, Calc Carb 30c, Cantharis 30c, Chamomilla 30c, Coffea Cruda 30c, Cuprum 30c, Lachesis 30c, Hyoscyamus 30c, Phytolacca 30c, Stramonium 30c, Veratrum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYTTA VESICATORIA; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; COPPER; LACHESIS MUTA VENOM; HYOSCYAMUS NIGER; PHYTOLACCA AMERICANA ROOT; DATURA STRAMONIUM; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0079_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0079 HUMAN OTC DRUG Throwing and Hitting Belladonna 30c, Colocynthis 30c Dulcamara 30c, Hyoscyamus 30c, Lillium 30c, Nux Vomica 30c, Staphysagria 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ATROPA BELLADONNA; CITRULLUS COLOCYNTHIS FRUIT PULP; SOLANUM DULCAMARA TOP; HYOSCYAMUS NIGER; LILIUM LANCIFOLIUM FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0080_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0080 HUMAN OTC DRUG Attention Span Aconite 30c, Aesculus 30c, Belladonna 30c, Bovista 30c, Hepar Sulph 30c, Hyoscyamus 30c, Ignatia 30c, Silicea 30c, Sticta 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; GIANT PUFFBALL; CALCIUM SULFIDE; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; SILICON DIOXIDE; LOBARIA PULMONARIA 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0081_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0081 HUMAN OTC DRUG Sibling Jealousy Arsenicum 30c, Calcarea Carb 30c, Chamomilla 30c, Hyoscyamus 30c, Ignatia 30c, Lachesis 30c, Pulsatilla 30c, Sepia 30c, Nux Vomica 30c, Natrum Mur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; STRYCHNOS NUX-VOMICA SEED; SODIUM CHLORIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0082_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0082 HUMAN OTC DRUG Loud Child Arnica 30c, Belladonna 30c,Hyoscyamus 30c, Lachesis 30c, Nux Moschata 30c, Silicea 30c, Sepia 30c, Stramonium 30c, Sulphur 30c, Veratrum Album 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; ATROPA BELLADONNA; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; NUTMEG; SILICON DIOXIDE; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; SULFUR; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0083_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0083 HUMAN OTC DRUG Speech Therapy Agaricus 30c, Belladonna 30c, Hyoscyamus 30c, Kali Brom 30c, Natrum Mur 30c, Nux Vomica 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; HYOSCYAMUS NIGER; POTASSIUM BROMIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0084_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0084 HUMAN OTC DRUG Growing Pains Calc Carb 30c, Calc Phos 30c, Eupatorium 30c, Guaicum 30c, Phosphoricum Acidum 30c, Ruta Grav 30c, SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; GUAIAC; PHOSPHORIC ACID; RUTA GRAVEOLENS FLOWERING TOP 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0085_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0085 HUMAN OTC DRUG Hypersensitivity Aconite 30c, Aurum Nat Mur 30c, Belladonna 30c, Chamomilla 30c, Gelseium 30c, Kali Phos 30c, Phosphorous, Pulsatilla 30c, Staphysagria 30, Teucrium 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; SODIUM TETRACHLOROAURATE; ATROPA BELLADONNA; MATRICARIA RECUTITA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM PHOSPHATE, DIBASIC; PHOSPHORUS; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; TEUCRIUM MARUM 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0086_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0086 HUMAN OTC DRUG Peepsing Argentum 30c, Belladonna 30c, Causticum 30c, Cina 30c, Equisetum 30c, Kreosotum 30c, Lycopodium 30c, Nux Vomica 30c, Sepia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics SILVER NITRATE; ATROPA BELLADONNA; CAUSTICUM; ARTEMISIA CINA PRE-FLOWERING TOP; EQUISETUM HYEMALE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0087_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0087 HUMAN OTC DRUG Night Terrors Borax 30c, Calc Carb 30c, Capsicum 30c, Chamomilla 30c, Cina 30c, Lac Can 30c, Kali Bromatum 30c, Stramonium 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; MATRICARIA RECUTITA; ARTEMISIA CINA PRE-FLOWERING TOP; CANIS LUPUS FAMILIARIS MILK; POTASSIUM BROMIDE; DATURA STRAMONIUM 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0088_f6555c5a-f43b-4178-b78a-42dcdb9c4618 59667-0088 HUMAN OTC DRUG Nighty Night Argentum 30c, Arsenicum 30c, Belladonna 30c, Calc Phos 30c, Chelidonium 30c, Coffea 30c, Lillium 30c, Podophyllum 30c Pulsatilla 30c, Rhus Tox 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; CHELIDONIUM MAJUS; ARABICA COFFEE BEAN; LILIUM LANCIFOLIUM WHOLE FLOWERING; PODOPHYLLUM; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0089_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0089 HUMAN OTC DRUG Asthma Abies Canadensis 30c, Adrenalinum 30c, Ammi Visnaga 30c, Cat Hair 30c, Eriodictyon 30c, Eucalyptus Glob 30c, Human Dandruff 30c, House Dust Mites 30c, Okoubaka 30c, Origanum 30c, Melissa Officionalis 30c Myrtus Communis 30c Mentha Pepperita 30c, Pinus Sylvestris. 30c, SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics TSUGA CANADENSIS BARK; EPINEPHRINE; AMMI VISNAGA FRUIT; FELIS CATUS HAIR; ERIODICTYON CALIFORNICUM LEAF; EUCALYPTUS GLOBULUS LEAF; HUMAN DANDER; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; OKOUBAKA AUBREVILLEI BARK; ORIGANUM MAJORANA WHOLE; MELISSA OFFICINALIS; MYRTUS COMMUNIS TOP; MENTHA PIPERITA; PINUS SYLVESTRIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0090_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0090 HUMAN OTC DRUG Whooping Cough 2 Aconite 30c, Ambrosia 30c, Castanea Sativa 30c, Chelidonium 30c, Cuprum Aceticum 30c, Dulcamara 30c, Hepar Sulph 30c, Hydrocyanicum 30c, Hyoscyamus 30c, Kali Bich 30c Kali Mur 30c Lobelia30c, Mag Phos. 30c, Naphtha 30c, Sepia 30c, Trifolium 30c, Justicia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS; AMBROSIA ARTEMISIIFOLIA; CASTANEA SATIVA FLOWER; CHELIDONIUM MAJUS; CUPRIC ACETATE; SOLANUM DULCAMARA TOP; CALCIUM SULFIDE; HYDROGEN CYANIDE; HYOSCYAMUS NIGER; POTASSIUM DICHROMATE; POTASSIUM CHLORIDE; LOBELIA INFLATA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; NAPHTHALENE; SEPIA OFFICINALIS JUICE; TRIFOLIUM PRATENSE FLOWER; JUSTICIA ADHATODA LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0091_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0091 HUMAN OTC DRUG Difficult Expectoration antimonium tart 30c, arsenicum 30c, belladonna 30c, bacillinum 200c, calcarea carb 30c, cactus 30c, causticum 30c, cuprum met. 30c, dulcamara 30c, ipecac 30c, hepar sulph 30c, kali sulph 30c, lycopodium 30c, natrum carb 30c, nux vomica 30c, phosphorus 30c, pulsatilla 30c, sepia 30c, senega 30c, SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ESCHERICHIA COLI; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SELENICEREUS GRANDIFLORUS STEM; CAUSTICUM; COPPER; SOLANUM DULCAMARA TOP; IPECAC; CALCIUM SULFIDE; POTASSIUM SULFATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; POLYGALA SENEGA ROOT 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0092_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0092 HUMAN OTC DRUG Chest Cold Antimonium Tart 30c, Bacillinum 200c, Bryonia 30c, Camphora 30c, Chelidonoium 30c, Grindelia 30c, Kreosotum 30c, Lycopodium 30c, Natrum Sulph 30c, Phosphorous 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANTIMONY POTASSIUM TARTRATE; ESCHERICHIA COLI; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CHELIDONIUM MAJUS; GRINDELIA HIRSUTULA FLOWERING TOP; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; PHOSPHORUS 30; 200; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0093_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0093 HUMAN OTC DRUG Bronchitis Aesculos 30c, Antimonium Tart 30c, Arsenicum 30c, Baryta Mur 30c, Bryonia 30c, Causticum 30c, Dulcamara 30c, Hepar Sulph. 30c, Phosphorous 30c, Sanguinaria 30c , Senicio 30c, Stannum Met 30c, Sulphur 30c, Quebracho 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BARIUM CHLORIDE DIHYDRATE; BRYONIA ALBA ROOT; CAUSTICUM; SOLANUM DULCAMARA TOP; CALCIUM SULFIDE; PHOSPHORUS; SANGUINARIA CANADENSIS ROOT; SENECIO VULGARIS; TIN; SULFUR; ASPIDOSPERMA QUEBRACHO-BLANCO BARK 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0094_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0094 HUMAN OTC DRUG Whooping Cough Antimonium Tart 30c, Belladonna 30c, Carbo Veg 30c, Cina 30c, Coccus Cacti 30c, Cuprum Met 30c, Dioscorea 30c, Drosera 30c, Formalinum 30c, Ignatia 30c, Ipecac 30c, Kali Brom 30c, Kali Carb 30c, Kali Sulph 30c, Mephitis 30c, Nux Vomica 30c Pertussinum 30c, Pulsatilla 30c Veratrum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; ARTEMISIA CINA PRE-FLOWERING TOP; PROTORTONIA CACTI; COPPER; DIOSCOREA VILLOSA TUBER; DROSERA ROTUNDIFOLIA; FORMALDEHYDE; STRYCHNOS IGNATII SEED; IPECAC; POTASSIUM BROMIDE; POTASSIUM CARBONATE; POTASSIUM SULFATE; MEPHITIS MEPHITIS ANAL GLAND FLUID; STRYCHNOS NUX-VOMICA SEED; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; PULSATILLA VULGARIS; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0095_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0095 HUMAN OTC DRUG Wet Weather Asthma Arnica 30c, Belladonna 30c,Hyoscyamus 30c, Lachesis 30c, Nux Moschata 30c, Silicea 30c, Sepia 30c, Stramonium 30c, Sulphur 30c, Veratrum Album 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA; ATROPA BELLADONNA; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; NUTMEG; SILICON DIOXIDE; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; SULFUR; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0096_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0096 HUMAN OTC DRUG Asthma Allergies Allium Cepa 30c, Arsenicum 30c, Thuja 30c, Badiaga 30c, Carbo Veg 30c, Dulcamara 30c, Euphrasia 30c, Iodatum 30c, Naja 30c, Nat Sulph 30c, Nux Vomica 30c, Sabadilla 30c, Sinapis Nigra 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ONION; ARSENIC TRIOXIDE; SPONGILLA LACUSTRIS; THUJA OCCIDENTALIS LEAFY TWIG; ACTIVATED CHARCOAL; SOLANUM DULCAMARA TOP; EUPHRASIA STRICTA; IODINE; NAJA NAJA VENOM; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED; BLACK MUSTARD SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0098_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0098 HUMAN OTC DRUG Strep Throat Arum Tri 30c, Belledonna 30c, Carbo Animalis 30c, Causticum 30c, Echinacea30c, Hydrastis 30c, Lachesis 30c, Phosphorous 30c, Phytolacca 30c, Nitricum Acidum 30c, Nux Vomica 30c, Mercurius Sol 30c , streptococcinum 30c, Sabadilla 30c, Spigellia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARISAEMA TRIPHYLLUM ROOT; ATROPA BELLADONNA; CARBO ANIMALIS; CAUSTICUM; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LACHESIS MUTA VENOM; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; NITRIC ACID; STREPTOCOCCUS PYOGENES; STRYCHNOS NUX-VOMICA SEED; MERCURIUS SOLUBILIS; SCHOENOCAULON OFFICINALE SEED; SPIGELIA ANTHELMIA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0099_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0099 HUMAN OTC DRUG Lip and Tongue Tie Revision Artemisia30c, Calendula 30c, Carbolicum Acidum 30c, Hypericum 30c, Staphysagria 30c, Sulphuricum Acidum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARTEMISIA ABROTANUM FLOWERING TOP; CALENDULA OFFICINALIS FLOWERING TOP; PHENOL; HYPERICUM PERFORATUM; DELPHINIUM STAPHISAGRIA SEED; SULFURIC ACID 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0100_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0100 HUMAN OTC DRUG Tonsillitis Alumen 30c, Baryta Carb 30c, Baryta Mur 30c, Belladonna 30c, Ferrum Phos 30c Guiaicum 30c, Hepar Sulph 30c, Lac Caninum 30c, Lachesis 30c, Merc Sol 30c, Merc Dulcies 30c, Nitricum Acidum 30c, Silicea 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ALUM, POTASSIUM; BARIUM CHLORIDE DIHYDRATE; BARIUM CARBONATE; ATROPA BELLADONNA; FERROSOFERRIC PHOSPHATE; GUAIAC; CALCIUM SULFIDE; CANIS LUPUS FAMILIARIS MILK; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; CALOMEL; NITRIC ACID; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0101_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0101 HUMAN OTC DRUG Hand Foot Mouth Antimonium Crudum 30c, Argentum Nit 30c, Borax 30c, Kali Chloricum 30c, Mercurius Corr 30c, Nat Mur 30c, Nitricum Ac 30c, Sulphuricum Acidum 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANTIMONY TRISULFIDE; SILVER NITRATE; SODIUM BORATE; POTASSIUM CHLORATE; MERCURIC CHLORIDE; SODIUM CHLORIDE; NITRIC ACID; SULFURIC ACID 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0102_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0102 HUMAN OTC DRUG Ingrown Toenails Causticum 30c, Graphites 30c, Hepar Sulph 30c, Mag Phos 30c, Magnetis Polus Australis 30c, Nat Mur 30c, Nitricum Acidum 30c, Phosphoricum Ac 30c, Silicea 30c, sulphur 30c, Thuja 30c, Teucrium 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CAUSTICUM; GRAPHITE; CALCIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORIC ACID; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TEUCRIUM MARUM 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0103_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0103 HUMAN OTC DRUG Diabetes Aceticum Acidum, Alloxanum, Bovista, Carcinocinum, Helonias, Lycopodium, Phosphoricum Acidum, Phosphorus, Plumbum Met, Tarentula. Syzygium ,Terebinthiniae, Uranium Nit. SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACETIC ACID; ALLOXAN; GIANT PUFFBALL; HUMAN BREAST TUMOR CELL; CHAMAELIRIUM LUTEUM ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; LEAD; LYCOSA TARANTULA; SYZYGIUM CUMINI SEED; TURPENTINE OIL; URANYL NITRATE HEXAHYDRATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0104_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0104 HUMAN OTC DRUG Cerebral Palsy Arnica 30c, Causticum 30c, Conium Mac 30c, Gelsemium 30c, Helleborus 30c, Ignatia 30c, Lathyrus 30c, Opium 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARNICA MONTANA FLOWER; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LATHYRUS SATIVAS SEED; OPIUM 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0105_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0105 HUMAN OTC DRUG Angry Eyebrows Aconite 30c, Anacardium 30c, Arsenicum 30c, Aurum Met. 30c, Bryonia 30c, Chamomilla 30c, Hepar Sulph 30c, Ignatia 30c, Kali Sulph 30c, Lycopodium 30c, Merc Sol 30c, Nat Mur 30c, Nitricum Acidum 30c, Nux Vomica 30c, Petroleum 30c, Sepia 30c, Staphysagria 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ACONITUM NAPELLUS ROOT; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; GOLD; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CALCIUM SULFIDE; STRYCHNOS IGNATII SEED; POTASSIUM SULFATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; KEROSENE; SEPIA OFFICINALIS JUICE; SULFUR; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0106_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0106 HUMAN OTC DRUG Mellow Out Arsenicum 30c, Chamomilla 30c, Cina 30c, Glononium 30c, Hyoscyamus 30c, Medorrhinum 30c, Stramonium 30c, Tarentula 30c, Veratrum Album 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ARSENIC TRIOXIDE; MATRICARIA RECUTITA; ARTEMISIA CINA PRE-FLOWERING TOP; NITROGLYCERIN; HYOSCYAMUS NIGER; GONORRHEAL URETHRAL SECRETION HUMAN; DATURA STRAMONIUM; LYCOSA TARANTULA; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0107_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0107 HUMAN OTC DRUG Absent Minded Androc 30c, Apis 30c, Cannabis Indica 30c, Causticum 30c, Chamomilla 30c, Helleborus 30c, Iridium Met 30c, Lachesis 30c, Mezereum 30c, Nat Mur 30c, Nux Moschata 30c, Platina 30c, Pulsatilla 30c, Sepia 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics ANDROCTONUS AUSTRALIS VENOM; APIS MELLIFERA VENOM; CANNABIS SATIVA SUBSP. INDICA TOP; CAUSTICUM; MATRICARIA RECUTITA; HELLEBORUS NIGER ROOT; IRIDIUM; LACHESIS MUTA VENOM; DAPHNE MEZEREUM BARK; SODIUM CHLORIDE; NUTMEG; PLATINUM; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0108_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0108 HUMAN OTC DRUG Memory Boost Baryta Carb 30c, Carbolicum Acidum 30c, Calc Carb 30c, Calc Phos 30c, Chelidonium 30c, Carboneum Sulph 30c, Hydrastis 30c, Hyoscyamus 30c Lac Can 30c, Nux Moschata 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics BARIUM CARBONATE; PHENOL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; CHELIDONIUM MAJUS; CARBON DISULFIDE; GOLDENSEAL; HYOSCYAMUS NIGER; CANIS LUPUS FAMILIARIS MILK; NUTMEG; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0109_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0109 HUMAN OTC DRUG Stye in the Eye Calc Fluor 30c,, Conium Mac 30c,, Carboneum Sulph 30c, Digitalis 30c, Graphites 30c, Lycopodium 30c, Pulsatilla 30c, Sepia 30c, Silicea 30c, Staphysagria 30c, Sulphur 30c SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics CALCIUM FLUORIDE; CONIUM MACULATUM FLOWERING TOP; CARBON DISULFIDE; DIGITALIS; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59667-0110_37edf4a0-9d71-450c-bf01-cd3641edb149 59667-0110 HUMAN OTC DRUG Weight Loss Ambra Grisea 30c, Antimonium Crudum 30c, Calc Carb 30c, Capsicum 30c, Ferrum Met 30c, Graphites 30c, Kali Carb 30c, Phytolacca 30c, Sepia SPRAY ORAL 20130802 UNAPPROVED HOMEOPATHIC Home Sweet Homeopathics AMBERGRIS; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; IRON; GRAPHITE; POTASSIUM CARBONATE; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C] E 20171231 59672-0032_aa36b3e2-9cfa-47f0-9559-ed6612e5396d 59672-0032 HUMAN OTC DRUG Arnica Arnica Montana TABLET ORAL 20140307 UNAPPROVED HOMEOPATHIC LC Industries ARNICA MONTANA 30 [hp_C]/1 N 20181231 59672-0116_d9023951-af32-4f16-aced-c101afd6e06c 59672-0116 HUMAN OTC DRUG NO-JET-LAG Lite Arnica Montana, Bellis Perennis, Matricaria Recutita, Ipecac, and Lycopodium Clavatum Spore TABLET ORAL 20110808 UNAPPROVED HOMEOPATHIC Miers Laboratories ARNICA MONTANA; BELLIS PERENNIS; MATRICARIA RECUTITA; IPECAC; LYCOPODIUM CLAVATUM SPORE 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59672-0130_0055b112-9820-4fad-b7e0-58264b97fb60 59672-0130 HUMAN OTC DRUG NO-JET-LAG Arnica Montana, Bellis Perennis, Matricaria Recutita, Ipecac, and Lycopodium Clavatum Spore TABLET ORAL 20110808 UNAPPROVED HOMEOPATHIC LC Industries ARNICA MONTANA; BELLIS PERENNIS; MATRICARIA RECUTITA; IPECAC; LYCOPODIUM CLAVATUM SPORE 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59672-0133_a3438eaa-37c0-4ca9-995f-90f000e64726 59672-0133 HUMAN OTC DRUG NO-JET-LAG Bewell Arnica Montana, Bellis Perennis, Matricaria Chamomilla, Ipecac, and Lycopodium Clavatum Spore TABLET ORAL 20170912 UNAPPROVED HOMEOPATHIC LC Industries ARNICA MONTANA; BELLIS PERENNIS; MATRICARIA CHAMOMILLA; IPECAC; LYCOPODIUM CLAVATUM SPORE 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59672-0230_ca070797-f7c8-4e2d-aa0b-a7e30e27b466 59672-0230 HUMAN OTC DRUG No-Shift-Lag Arnica Montana, Bellis Perennis, Ipecac, Phytolacca Americana Root, and Zinc TABLET ORAL 20160120 UNAPPROVED HOMEOPATHIC LC Industries ARNICA MONTANA; BELLIS PERENNIS; IPECAC; PHYTOLACCA AMERICANA ROOT; ZINC 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59672-0332_98384ef5-e164-43ab-82bd-b7b43ff24307 59672-0332 HUMAN OTC DRUG Sports Ease Arnica Montana, Bellis Perennis, Bryonia Alba Root, Ledum Palustre Twig, and Plantago Major TABLET ORAL 20160120 UNAPPROVED HOMEOPATHIC LC Industries ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; LEDUM PALUSTRE TWIG; PLANTAGO MAJOR 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59672-0432_9c165c02-0a5d-47e3-b802-c05ba2830e58 59672-0432 HUMAN OTC DRUG Femme Ease Bryonia Alba Root, Oyster Shell Calcium Carbonate, Crude, Gelsemium Sempervirens Root, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, and Sepia Officinalis Juice TABLET ORAL 20160208 UNAPPROVED HOMEOPATHIC LC Industries BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59672-0532_241f2e67-bdc5-4829-8901-2c84929fa5e8 59672-0532 HUMAN OTC DRUG Drink Ease Avena Sativa Flowering Top, Capsicum, Strychnos Nux-Vomica Seed, Veratrum Album Root, and Zinc TABLET ORAL 20120405 UNAPPROVED HOMEOPATHIC LC Industries AVENA SATIVA FLOWERING TOP; CAPSICUM; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT; ZINC 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59672-0732_977f1de9-3567-4053-ac35-eeb15012f936 59672-0732 HUMAN OTC DRUG TRIP EASE SODIUM BORATE, ANAMIRTA COCCULUS SEED, GELSEMIUM SEMPERVIRENS ROOT, WOOD CREOSOTE, TOXICODENDRON PUBESCENS LEAF, AND TOBACCO LEAF TABLET ORAL 20120504 UNAPPROVED HOMEOPATHIC LC Industries SODIUM BORATE; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; WOOD CREOSOTE; TOXICODENDRON PUBESCENS LEAF; TOBACCO LEAF 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59672-0916_fa9a0a6f-87e3-4cc5-a0dc-65ceadc10893 59672-0916 HUMAN OTC DRUG NO-WEAK-NAILS GRAPHITE, THUJA OCCIDENTALIS LEAFY TWIG, and SILICON DIOXIDE TABLET ORAL 20140915 UNAPPROVED HOMEOPATHIC LC Industries GRAPHITE; THUJA OCCIDENTALIS LEAFY TWIG; SILICON DIOXIDE 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59676-225_12d85af0-5fe3-4258-9f07-1e25662f599b 59676-225 HUMAN PRESCRIPTION DRUG OLYSIO simeprevir CAPSULE ORAL 20131122 NDA NDA205123 Janssen Products LP SIMEPREVIR 150 mg/1 Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],HCV NS3/4A Protease Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA] N 20181231 59676-278_cb979e5d-5aac-43ee-8216-7dd42be420ad 59676-278 HUMAN PRESCRIPTION DRUG EDURANT rilpivirine hydrochloride TABLET, FILM COATED ORAL 20110520 NDA NDA202022 Janssen Products, LP RILPIVIRINE HYDROCHLORIDE 25 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [Chemical/Ingredient] N 20181231 59676-302_c4e1fe65-8d28-441e-9720-1b674259aefc 59676-302 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 2000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59676-303_c4e1fe65-8d28-441e-9720-1b674259aefc 59676-303 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 3000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59676-304_c4e1fe65-8d28-441e-9720-1b674259aefc 59676-304 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 4000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59676-310_c4e1fe65-8d28-441e-9720-1b674259aefc 59676-310 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 10000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59676-312_c4e1fe65-8d28-441e-9720-1b674259aefc 59676-312 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 10000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59676-320_c4e1fe65-8d28-441e-9720-1b674259aefc 59676-320 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 20000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59676-340_c4e1fe65-8d28-441e-9720-1b674259aefc 59676-340 HUMAN PRESCRIPTION DRUG PROCRIT Erythropoietin INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19890601 BLA BLA103234 Janssen Products, LP ERYTHROPOIETIN 40000 [iU]/mL Erythropoiesis-stimulating Agent [EPC],Erythropoietin [Chemical/Ingredient],Increased Erythroid Cell Production [PE] N 20181231 59676-562_0ef4426d-f0c1-4528-8e4a-2465d3106600 59676-562 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20080308 NDA NDA021976 Janssen Products LP DARUNAVIR ETHANOLATE 600 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 59676-563_0ef4426d-f0c1-4528-8e4a-2465d3106600 59676-563 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20090114 NDA NDA021976 Janssen Products LP DARUNAVIR ETHANOLATE 75 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 59676-564_0ef4426d-f0c1-4528-8e4a-2465d3106600 59676-564 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20090427 NDA NDA021976 Janssen Products LP DARUNAVIR ETHANOLATE 150 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 59676-565_0ef4426d-f0c1-4528-8e4a-2465d3106600 59676-565 HUMAN PRESCRIPTION DRUG PREZISTA darunavir SUSPENSION ORAL 20111216 NDA NDA202895 Janssen Products LP DARUNAVIR ETHANOLATE 100 mg/mL HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 59676-566_0ef4426d-f0c1-4528-8e4a-2465d3106600 59676-566 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20121109 NDA NDA021976 Janssen Products LP DARUNAVIR ETHANOLATE 800 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 59676-570_10c0b502-9857-436d-883f-602b1f684aca 59676-570 HUMAN PRESCRIPTION DRUG Intelence etravirine TABLET ORAL 20080118 NDA NDA022187 Janssen Products LP ETRAVIRINE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 59676-571_10c0b502-9857-436d-883f-602b1f684aca 59676-571 HUMAN PRESCRIPTION DRUG Intelence etravirine TABLET ORAL 20101222 NDA NDA022187 Janssen Products LP ETRAVIRINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 59676-572_10c0b502-9857-436d-883f-602b1f684aca 59676-572 HUMAN PRESCRIPTION DRUG Intelence etravirine TABLET ORAL 20120326 NDA NDA022187 Janssen Products LP ETRAVIRINE 25 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 59676-575_e1c04c0d-c2fe-4dc9-9639-fc17846001cd 59676-575 HUMAN PRESCRIPTION DRUG PREZCOBIX DARUNAVIR ETHANOLATE and COBICISTAT TABLET, FILM COATED ORAL 20150131 NDA NDA205395 Janssen Products LP DARUNAVIR ETHANOLATE; COBICISTAT 800; 150 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 59676-610_658a90ab-8ac0-4d7e-b8af-44cd0625c779 59676-610 HUMAN PRESCRIPTION DRUG YONDELIS Trabectedin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20151023 NDA NDA207953 Janssen Products, LP TRABECTEDIN .05 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 59676-701_c56031fe-df6c-40cc-ba5e-36b53206ce0b 59676-701 HUMAN PRESCRIPTION DRUG SIRTURO Bedaquiline Fumarate TABLET ORAL 20121228 NDA NDA204384 Janssen Products, LP BEDAQUILINE FUMARATE 100 mg/1 Diarylquinoline Antimycobacterial [EPC],Diarylquinolines [Chemical/Ingredient] N 20181231 59676-960_17206b15-725c-410d-838d-ccb228c6ea2b 59676-960 HUMAN PRESCRIPTION DRUG DOXIL doxorubicin hydrochloride INJECTION, SUSPENSION, LIPOSOMAL INTRAVENOUS 19951117 NDA NDA050718 Janssen Products, LP DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 59676-966_2dd41244-8b08-438c-a2e1-df9e704fe8a2 59676-966 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride liposome doxorubicin hydrochloride INJECTION, SUSPENSION, LIPOSOMAL INTRAVENOUS 20170626 NDA NDA050718 Janssen Products, LP DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 59679-001_936b1446-8c27-4689-8164-adcb0005f13a 59679-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130612 UNAPPROVED MEDICAL GAS Helping Hands Medical Supply OXYGEN 99 L/100L E 20171231 59702-661_d3c69436-a681-4e00-8db0-8cbfaac9627e 59702-661 HUMAN PRESCRIPTION DRUG ORBIVAN Butalbital, Acetaminophen, and Caffeine CAPSULE ORAL 20100423 ANDA ANDA040885 Atley Pharmaceuticals, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 300; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII E 20171231 59704-0001_42f95eb4-1339-44c5-b24e-c1f696511ee7 59704-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS ALA Med dba Pulmonary Care Services OXYGEN 99 L/100L N 20191231 59713-001_252e4485-ea4a-4942-a585-977984250be2 59713-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RECTAL 19920701 UNAPPROVED MEDICAL GAS Ann Arbor Welding Supply Co., Inc. DBA Arbor Specialty Gases OXYGEN 990 mL/L N 20181231 59714-002_60dd0b6f-fad3-11d2-e053-2991aa0aff79 59714-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19691021 NDA NDA205767 Airway Oxygen, Inc. OXYGEN 99.1 L/L N 20181231 59714-101_db07db3e-3bb8-4dc8-b608-8de5bd2a74c5 59714-101 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN LIQUID RESPIRATORY (INHALATION) 19691021 UNAPPROVED MEDICAL GAS AIRWAY OXYGEN INC OXYGEN 99 L/100L E 20171231 59723-546_8f3f9c0b-8e22-4d58-98da-265e482f0f5c 59723-546 HUMAN OTC DRUG COMPLIANCE DISHWASHING LIQUID CHLOROXYLENOL SOAP TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part333E ROYAL PAPER CORPORATION CHLOROXYLENOL 3 g/1000mL E 20171231 59726-005_0c5c6711-a27e-458c-805b-2aa7c72cdbb9 59726-005 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20111201 OTC MONOGRAPH NOT FINAL part334 P & L Development of New York Corporation DOCUSATE SODIUM 100 mg/1 N 20181231 59726-016_9b417bb6-ebc3-4ed2-9d8d-9f2b38ffb881 59726-016 HUMAN OTC DRUG pain reliever extra strength Acetaminophen TABLET ORAL 20110815 OTC MONOGRAPH NOT FINAL part343 P and L Development of New York Corporation ACETAMINOPHEN 500 mg/1 N 20181231 59726-019_0d267c20-bea6-4e90-a168-301ce021d57e 59726-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130115 ANDA ANDA202727 P and L Development of New York Corporation LANSOPRAZOLE 15 mg/1 N 20181231 59726-020_4a9c606b-2d91-4465-8bfc-8b3d544c8999 59726-020 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130731 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 59726-021_3cda1309-7cf0-4e82-aec0-0fab25daebc6 59726-021 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 P and L Development of New York Corporation (ReadyInCase) ASPIRIN 81 mg/1 N 20181231 59726-022_e4bcce6c-9aaa-4789-a66d-952f9ab53cbf 59726-022 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20140731 ANDA ANDA078682 P and L Development of New York Corporation (ReadyInCase) IBUPROFEN 200 mg/1 E 20171231 59726-023_9d20e514-bb75-4943-80c4-9839ce46889b 59726-023 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140630 ANDA ANDA091353 P and L Development of New York Corporation (ReadyInCase) NAPROXEN SODIUM 220 mg/1 N 20181231 59726-024_38a7dec0-ccee-4ffb-904d-5c28b3f54786 59726-024 HUMAN OTC DRUG All Day Allergy Relief Cetirizine HCl TABLET ORAL 20140731 ANDA ANDA078780 P and L Development of New York Corporation (ReadyInCase) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 59726-025_d8500c41-e539-458a-b7cb-6f670a13e90f 59726-025 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20140731 OTC MONOGRAPH FINAL part347 P and L Development of New York Corporation (ReadyInCase) DIMETHICONE 125 mg/1 E 20171231 59726-026_56bb7d9d-8654-40ac-890d-eadc453c8108 59726-026 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET ORAL 20140731 OTC MONOGRAPH NOT FINAL part334 P & L Development, LLC SENNOSIDES 25 mg/1 N 20181231 59726-027_74bbd4c1-ec8f-46db-861e-29ee45b30fca 59726-027 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr TABLET ORAL 20140731 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 59726-028_908f3a1c-fe18-458d-9de2-b5d9078983a7 59726-028 HUMAN OTC DRUG Daytime Cold and Flu Non Drowsy ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20171231 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 59726-029_c0513830-26c5-401a-b9e7-a7c63636877c 59726-029 HUMAN OTC DRUG Cold and Flu Relief Nighttime Multi Symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20140731 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 59726-030_2ec568b0-4a59-4ac0-b80e-5082f96299a2 59726-030 HUMAN OTC DRUG Night Time Cold and Flu Relief Multi Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20171231 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20191231 59726-031_9a081093-13db-4fec-b179-2c54adeee965 59726-031 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20150105 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 59726-032_4ec9a931-c4d6-40cd-b1b7-253f958b12a1 59726-032 HUMAN OTC DRUG Pain Reliever PM extra strength Acetaminophen Diphenhydramine HCI TABLET, COATED ORAL 20171231 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20191231 59726-072_c124c4af-10d9-4fb2-8ba0-a5093e64f480 59726-072 HUMAN OTC DRUG Daytime Nighttime Cold and Flu Relief Multi-Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20171231 OTC MONOGRAPH FINAL part341 P & L Development, LLC N 20191231 59726-100_b6026e9b-6337-42b7-888e-3fe1eb9b3536 59726-100 HUMAN OTC DRUG Daytime Sinus Relief Non Drowsy Acetaminophen and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20131007 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 59726-101_933fd611-027d-4d74-9e40-5447979d3479 59726-101 HUMAN OTC DRUG Nighttime Sinus Relief Acetaminophen, Doxylamine succinate and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20121031 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 59726-107_9e70de35-97d9-4434-a240-6c03c709cdb2 59726-107 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20121207 OTC MONOGRAPH FINAL part341 P & L Development, LLC GUAIFENESIN 400 mg/1 N 20181231 59726-109_546087f0-3f9a-42ff-885c-b488e75c9e46 59726-109 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan Hydrobromide and Guaifenesin TABLET ORAL 20100106 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 59726-117_1e9cd982-3088-46f3-bd5b-63e74818b838 59726-117 HUMAN OTC DRUG Pain Relief Ibuprofen TABLET, COATED ORAL 20120813 ANDA ANDA079174 P and L Development of New York Corporation IBUPROFEN 200 mg/1 N 20181231 59726-120_330de931-1b61-4b6a-875c-3db541af9151 59726-120 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120517 ANDA ANDA078682 PL Developments IBUPROFEN 200 mg/1 N 20181231 59726-127_8cd23c41-b25b-4a9f-85f1-d72be751f1a7 59726-127 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20130325 ANDA ANDA078653 P and L Development of New York Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 59726-129_d4e34fd4-8f08-4c4f-a148-86b532f0cfcc 59726-129 HUMAN OTC DRUG All Day Allergy Relief Cetirizine HCl TABLET ORAL 20100901 ANDA ANDA078780 P & L Development, LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 59726-159_b8dc4dd6-2b66-4b18-b2f7-732a74a92f8a 59726-159 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 P and L Development of New York Corporation (ReadyInCase) ACETAMINOPHEN 500 mg/1 N 20181231 59726-160_d6abd9ef-7589-4e86-a531-a7d7dce815df 59726-160 HUMAN OTC DRUG Senna S docusate sodium and sennosides TABLET ORAL 20120515 OTC MONOGRAPH NOT FINAL part334 P and L Development of New York Corporation SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 59726-165_b2834fcc-cba7-41a7-9460-14755621b330 59726-165 HUMAN OTC DRUG Ibuprofen and Diphenhydramine HCl IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED ORAL 20110901 ANDA ANDA090397 P and L Development of New York Corporation IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE 200; 25 mg/1; mg/1 E 20171231 59726-167_0720cdb6-3835-48a2-8530-c6f47a96142a 59726-167 HUMAN OTC DRUG Pain Relief Ibuprofen TABLET, COATED ORAL 20120928 ANDA ANDA072199 P and L Development of New York Corporation IBUPROFEN 200 mg/1 N 20181231 59726-169_45617c97-0ae0-417b-9ccc-8bd66cb1a89b 59726-169 HUMAN OTC DRUG All Day Pain Relief Naproxen sodium TABLET ORAL 20140228 ANDA ANDA079096 P and L Development of New York Corporation (ReadyInCase) NAPROXEN SODIUM 220 mg/1 N 20181231 59726-170_8632dcea-d09e-46be-8cf9-4dfc686f35d7 59726-170 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20111201 OTC MONOGRAPH NOT FINAL part334 P & L Development of New York Corporation DOCUSATE CALCIUM 240 mg/1 N 20181231 59726-186_56f564a3-c44c-45f2-8fa8-ce72ef250164 59726-186 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20151130 ANDA ANDA076460 P & L Development, LLC IBUPROFEN 200 mg/1 N 20181231 59726-189_52c0fbc5-e3c4-4cd0-92f3-cbe333fe850f 59726-189 HUMAN OTC DRUG Allergy Relief Fexofenadine HCl TABLET ORAL 20130328 ANDA ANDA079112 P and L Development of New York Corporation FEXOFENADINE HYDROCHLORIDE 180 mg/1 E 20171231 59726-190_f2af173d-8345-451e-88b9-055a576e335b 59726-190 HUMAN OTC DRUG Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20100901 OTC MONOGRAPH NOT FINAL part334 P & L Development, LLC BISACODYL 5 mg/1 N 20181231 59726-211_f40ae88b-a73d-412a-8392-259469f634fd 59726-211 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20130214 NDA NDA022429 P and L Development of New York Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 59726-212_a2083c28-766f-471f-978e-77308091858e 59726-212 HUMAN OTC DRUG All Day Allergy Relief Cetirizine HCl CAPSULE ORAL 20171231 NDA NDA022429 P & L Development, LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20191231 59726-220_eb44a8b3-be84-4e0f-8e4a-14b928b347c8 59726-220 HUMAN OTC DRUG All Day Allergy Antihistamine Cetirizine HCl TABLET ORAL 20121205 ANDA ANDA078427 P and L Development of New York Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 59726-224_0c45c799-cac2-449a-ae5e-ce98cd887766 59726-224 HUMAN OTC DRUG EZ Nite Sleep Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH FINAL part338 P and L Development of New York Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59726-225_17d1e2cd-f0f0-40b8-b050-db6ebac0d389 59726-225 HUMAN OTC DRUG SnoozEase Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130411 OTC MONOGRAPH FINAL part338 P and L Development of New York Corporation DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59726-227_dd5b7676-3306-4b8b-8d0d-c5a398f413f2 59726-227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20130301 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ASPIRIN 81 mg/1 N 20181231 59726-235_c3bdc233-622f-40cb-9f65-b4dfd4576a45 59726-235 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20141130 ANDA ANDA076460 P & L Development, LLC IBUPROFEN 200 mg/1 N 20181231 59726-236_875e8866-e482-4ead-bb2b-5aec5ebaad03 59726-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 59726-238_e3ef719f-1880-4aeb-8608-57e7ccd7f9c5 59726-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH NOT FINAL part334 P and L Development of New York Corporation (ReadyInCase) DOCUSATE SODIUM 100 mg/1 N 20181231 59726-242_f47ab631-af88-4a5c-8ae3-c8c06fbdbb7e 59726-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH FINAL part347 P and L Development of New York Corporation (ReadyInCase) DIMETHICONE 125 mg/1 E 20171231 59726-243_64fedfc5-6315-4927-b8a2-3afaf4b09525 59726-243 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 P & L Development, LLC DOCUSATE SODIUM 100 mg/1 N 20181231 59726-247_68379959-7c64-4fde-9571-07f7fa558ba6 59726-247 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20140501 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 59726-248_3a11305f-2ffe-4125-8757-51710973fe41 59726-248 HUMAN OTC DRUG Pain Relief Ibuprofen TABLET ORAL 20131130 ANDA ANDA079174 P and L Development of New York Corporation IBUPROFEN 200 mg/1 N 20181231 59726-249_6086a165-4ffb-4cec-bde4-5bf3e43fa0ba 59726-249 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20140228 ANDA ANDA079174 P and L Development of New York Corporation (ReadyInCase) IBUPROFEN 200 mg/1 N 20181231 59726-256_88d638de-1e8f-4f2f-a75a-740ca9dfcdd3 59726-256 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140328 ANDA ANDA091353 P and L Development of New York Corporation (ReadyInCase) NAPROXEN SODIUM 220 mg/1 N 20181231 59726-257_c337838a-0b7d-461a-8443-164565295d05 59726-257 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 P and L Development of New York Corporation (ReadyInCase) DOCUSATE CALCIUM 240 mg/1 E 20171231 59726-258_a5a18375-6880-4aff-af61-1cc92bc8c978 59726-258 HUMAN OTC DRUG STOOL SOFTENER Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 P and L Development of New York Corporation (ReadyInCase) DOCUSATE SODIUM 250 mg/1 E 20171231 59726-266_287b93d4-4fd8-47c0-af51-cbf5974de11d 59726-266 HUMAN OTC DRUG Allergy Relief Extra Strength Nighttime Diphenhydramine HCl TABLET ORAL 20150930 OTC MONOGRAPH FINAL part338 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 59726-360_eeec9bd3-d5db-4360-8dd5-4d872cb9ecf0 59726-360 HUMAN OTC DRUG Extra Strength Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20110902 OTC MONOGRAPH NOT FINAL part343 P and L Development of New York Corporation ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 59726-370_33fbcf19-6b19-44c6-9823-0f8aa1e345a0 59726-370 HUMAN OTC DRUG Enteric Coated Aspirin regular strength Aspirin TABLET, COATED ORAL 20160331 OTC MONOGRAPH FINAL part343 P & L Development, LLC ASPIRIN 325 mg/1 N 20181231 59726-400_640bf72c-0836-4060-910b-65ec7d160bae 59726-400 HUMAN OTC DRUG Nighttime Sleep Easy DIPHENHYDRAMINE HCL TABLET ORAL 20121204 OTC MONOGRAPH FINAL part338 P and L Development of New York Corporation (ReadyInCase) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59726-404_2623ca3f-acaa-4542-a642-7b669e59cea4 59726-404 HUMAN OTC DRUG Sleep Aid NightTime Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part338 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59726-405_0da4b193-27d0-4810-978b-6fc91e2e0497 59726-405 HUMAN OTC DRUG Sleep-Aid Nighttime Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20171231 OTC MONOGRAPH FINAL part338 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 59726-447_d8aaa2a6-07f8-4cd8-b96b-f5a36f2757dc 59726-447 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20141130 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 59726-457_ec926488-49b9-4ecd-9c18-92bba05a68ca 59726-457 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20150131 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN 500 mg/1 N 20181231 59726-468_0b636b82-82a4-4dde-bc3c-d18a3607ef75 59726-468 HUMAN OTC DRUG Daytime Cold Flu multi Symptom Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20150731 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 59726-470_f020df9c-0eda-4d21-9221-461775e7a70b 59726-470 HUMAN OTC DRUG Multi- Symptom Relief DayTime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20120201 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 59726-471_f8c73535-bf70-4130-842c-b4f0694026fc 59726-471 HUMAN OTC DRUG Night time cold and flu multi symptom ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20150731 OTC MONOGRAPH FINAL part341 P & L Development, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 59726-480_843d93e6-265d-4092-bbed-2896c35ae67e 59726-480 HUMAN OTC DRUG Multi-Symptom Nitetime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20111010 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 59726-483_8e96456b-b3bc-4c98-9f82-32fa1f3e6e3c 59726-483 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150930 OTC MONOGRAPH FINAL part336 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59726-487_fe95ce37-314b-4f6a-8764-f1d065eb1305 59726-487 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20160131 OTC MONOGRAPH FINAL part347 P & L Development, LLC DIMETHICONE 125 mg/1 N 20181231 59726-494_97658e2c-1f32-49cf-b6ac-25e72db4911f 59726-494 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20160331 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN 500 mg/1 N 20181231 59726-504_4a225b1c-6c4b-4f93-9f59-2d6afa333ec8 59726-504 HUMAN OTC DRUG Allergy Relief Fexofenadine HCl TABLET ORAL 20160331 ANDA ANDA079112 P & L Development, LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 59726-520_2bdd5d0b-5e25-4286-808c-7403e506583f 59726-520 HUMAN OTC DRUG Loperamide HCl Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20110830 NDA NDA021855 P & L Development, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 59726-525_ef7a0ca9-54fc-4cd6-960c-e9840568975a 59726-525 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20160630 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 59726-530_603b57a1-f10d-4aae-9a96-7f0f304adf6f 59726-530 HUMAN OTC DRUG Ultra Strength Gas Relief SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20110901 OTC MONOGRAPH FINAL part332 P and L Development of New York Corporation (ReadyInCase) DIMETHICONE 180 mg/1 E 20171231 59726-568_963b1002-20b6-4656-bdbf-8f17f64822f3 59726-568 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20170331 ANDA ANDA079174 P & L Development, LLC IBUPROFEN 200 mg/1 N 20181231 59726-578_7d967403-f072-4dc2-b9e8-98a19524e7f7 59726-578 HUMAN OTC DRUG Stool Softener Laxative DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170831 OTC MONOGRAPH NOT FINAL part334 P & L Development, LLC DOCUSATE SODIUM 100 mg/1 N 20181231 59726-580_0707e67a-18c8-4e66-9b64-5ed69cc97734 59726-580 HUMAN OTC DRUG Ranitidine Ranitidine TABLET ORAL 20130319 ANDA ANDA078884 P and L Development of New York Corporation RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 59726-660_592cb582-bdcf-4e62-9957-7401203a59ca 59726-660 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20160930 OTC MONOGRAPH NOT FINAL part343 P & L Development, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 59726-661_fb91e332-e636-4c1f-aa60-e33bc4795a78 59726-661 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20170831 ANDA ANDA079174 P & L Development, LLC IBUPROFEN 200 mg/1 N 20181231 59726-670_5bd11daa-1584-45b3-9841-59444e43293d 59726-670 HUMAN OTC DRUG Nasal Decongestant Maximum Strength Phenylephrine HCl TABLET ORAL 20140228 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 59726-691_6d2c125c-2714-4e52-9156-7d78d0e4b3a4 59726-691 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20130827 OTC MONOGRAPH FINAL part341 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59726-692_ee52c044-de7c-437a-8c5c-0b828e144794 59726-692 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 20171231 OTC MONOGRAPH FINAL part336 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 59726-720_17fddc93-b2e9-44dd-b792-f9f7a340bf04 59726-720 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20130207 OTC MONOGRAPH FINAL part336 P and L Development of New York Corporation (ReadyInCase) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59726-736_de6807f7-d6ba-47bb-a7da-df995fbddfdb 59726-736 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20171231 OTC MONOGRAPH FINAL part341 P & L Development, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20191231 59726-810_2b1de167-01cb-4083-a835-9e90cbac6f37 59726-810 HUMAN OTC DRUG Sinus and Allergy Releif PE Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20140228 OTC MONOGRAPH FINAL part341 P and L Development of New York Corporation (ReadyInCase) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 59726-890_b0472468-0200-4251-9a68-edff30d30bf3 59726-890 HUMAN OTC DRUG Acti PE Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20150228 OTC MONOGRAPH FINAL part341 P & L Development, LLC CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 59730-4202_b2145184-7093-495f-a36b-8bf1d56b6a09 59730-4202 HUMAN PRESCRIPTION DRUG NABI-HB HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN INJECTION INTRAMUSCULAR 20100310 BLA BLA991442 Biotest Pharmaceuticals Corporation HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU]/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] N 20181231 59730-4203_41d93a91-4ad9-4906-b200-e2854074b516 59730-4203 HUMAN PRESCRIPTION DRUG NABI-HB HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN INJECTION INTRAMUSCULAR 20100312 BLA BLA991442 Biotest Pharmaceuticals Corporation HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 1560 [iU]/5mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] N 20181231 59730-6502_61d0b0f9-a621-325f-e053-2a91aa0a9680 59730-6502 PLASMA DERIVATIVE BIVIGAM HUMAN IMMUNOGLOBULIN G INJECTION, SOLUTION INTRAVENOUS 20130204 BLA BLA125389 Biotest Pharmaceuticals Corporation HUMAN IMMUNOGLOBULIN G 5 g/50mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20191231 59730-6503_61d0b0f9-a621-325f-e053-2a91aa0a9680 59730-6503 PLASMA DERIVATIVE BIVIGAM HUMAN IMMUNOGLOBULIN G INJECTION, SOLUTION INTRAVENOUS 20130204 BLA BLA125389 Biotest Pharmaceuticals Corporation HUMAN IMMUNOGLOBULIN G 10 g/100mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20191231 59735-100_74ebb324-403e-4cfe-8f15-e16e7512c936 59735-100 HUMAN OTC DRUG BO SPF15 Avobenzone, Octinoxate LOTION TOPICAL 20130927 OTC MONOGRAPH NOT FINAL part352 Mana Products AVOBENZONE; OCTINOXATE 3; 7.5 g/100g; g/100g N 20181231 59735-130_63b32367-3208-4427-bad3-c9c17fe4f1ec 59735-130 HUMAN OTC DRUG Daily Moisturizer Broad-Spectrum SPF 30 Avobenzone, Octinoxate, Octisalate LOTION TOPICAL 20140127 OTC MONOGRAPH NOT FINAL part352 Mana Products AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100g; g/100g; g/100g N 20181231 59735-140_3bff8bfc-bcab-4aff-e054-00144ff8d46c 59735-140 HUMAN OTC DRUG Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen LOTION TOPICAL 20160908 OTC MONOGRAPH FINAL part352 Mana Products OCTINOXATE; TITANIUM DIOXIDE 7.5; 10 g/100g; g/100g N 20181231 59735-150_4316f872-e167-1497-e054-00144ff8d46c 59735-150 HUMAN OTC DRUG DERMAdoctor DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30 DERMAdoctor DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30 LOTION TOPICAL 20161207 OTC MONOGRAPH FINAL part352 Mana Products ZINC OXIDE; TITANIUM DIOXIDE 12.05; 3.3 g/100g; g/100g N 20181231 59735-160_491f8925-b1e8-3372-e054-00144ff8d46c 59735-160 HUMAN OTC DRUG Your Name Cosmetics Brightening CC Cream Broad Spectrum SPF 20 Your Name Cosmetics Brightening CC Cream Broad Spectrum SPF 20 LOTION TOPICAL 20170221 OTC MONOGRAPH FINAL part352 Mana Products OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; .99 g/100g; g/100g; g/100g N 20181231 59735-170_63a167f4-e0f0-2ac6-e053-2991aa0a7c2e 59735-170 HUMAN OTC DRUG Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20 Your Name Cosmetics Mineral Sheet Tint Broad Spectrum SPF 20 LOTION TOPICAL 20180125 OTC MONOGRAPH FINAL part352 Mana Products TITANIUM DIOXIDE 5 g/100g N 20191231 59735-300_a892e1d1-fc68-48db-9c42-debd4d555525 59735-300 HUMAN OTC DRUG Cover and Conceal Blemish Concealer Salicylic Acid CREAM TOPICAL 20040720 OTC MONOGRAPH FINAL part333 Biocosmetics research labs SALICYLIC ACID 1 g/100g N 20181231 59735-302_1b8daa10-04f4-497b-8463-fcb81d685834 59735-302 HUMAN OTC DRUG Acne and Blemish Target Salicylic Acid GEL TOPICAL 20030213 OTC MONOGRAPH FINAL part333 Biocosmetics Research Labs SALICYLIC ACID 2 g/100g N 20181231 59735-304_61be7ea1-7188-4fd6-9c3a-81b0eb76fff4 59735-304 HUMAN OTC DRUG Body Fade Creme Maximum Strength Hydroquinone CREAM TOPICAL 20091208 OTC MONOGRAPH FINAL part354 Biocosmetic Reasearch Labs HYDROQUINONE 2 g/100g N 20181231 59735-306_57a46a6a-3434-4dbe-82d6-794c9ad50038 59735-306 HUMAN OTC DRUG Daily Fade SPF15 Sunscreen CREAM TOPICAL 20060306 OTC MONOGRAPH NOT FINAL part352 Biocosetic Research Labs AVOBENZONE; OCTINOXATE 2; 5 g/100g; g/100g N 20181231 59735-308_e291cf51-0a51-4917-8b14-982ea3d5a322 59735-308 HUMAN OTC DRUG Daily Fade Maximum Strength SPF15 Hydroquinone SPF15 CREAM TOPICAL 20090603 OTC MONOGRAPH NOT FINAL part358 Biocosmetic Research Labs HYDROQUINONE; AVOBENZONE; OCTINOXATE 2; 2; 5 g/100g; g/100g; g/100g N 20181231 59735-310_fed097e8-f13e-411b-b54c-5a7b0f433c84 59735-310 HUMAN OTC DRUG Advanced Dual Complex Fade Maximum Strength Plus Hydroquinone GEL TOPICAL 20090225 OTC MONOGRAPH NOT FINAL part358 Biocosmetic Research Labs HYDROQUINONE 2 g/100g N 20181231 59735-312_1d33bb86-a544-4fdc-9f16-c76b848ab303 59735-312 HUMAN OTC DRUG Anti-acne Salicylic Acid LOTION TOPICAL 20080123 OTC MONOGRAPH FINAL part333 Biocosmetics Research Labs SALICYLIC ACID 2 g/100g N 20181231 59735-314_7ebadcb8-7c7b-4409-8653-900b361ecc54 59735-314 HUMAN OTC DRUG Skin Perfecting Acne and Blemish Wash Salicylic Acid RINSE TOPICAL 20060619 OTC MONOGRAPH FINAL part333 Biocosmetics Research Labs SALICYLIC ACID .5 mL/100mL N 20181231 59735-318_caf1f5b5-8bef-471c-9775-773a7e5ade71 59735-318 HUMAN OTC DRUG Essential Fade Complex Hydroquinone gel GEL TOPICAL 20110120 OTC MONOGRAPH NOT FINAL part358A Biocosmetics Research Lab HYDROQUINONE 2 g/100g N 20181231 59741-101_1152a6d5-9ec2-42d9-b6c9-4ac696445375 59741-101 HUMAN OTC DRUG Childrens Acetaminophen Pain Relief Acetaminophen SOLUTION ORAL 20100801 OTC MONOGRAPH NOT FINAL part343 Bio-Pharm, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 59741-112_4f181b2f-d869-4831-af2b-8ded00d7f55d 59741-112 HUMAN OTC DRUG Tussin Guaifenesin SOLUTION ORAL 20140408 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. GUAIFENESIN 100 mg/5mL N 20181231 59741-116_bca62c37-a132-4af3-b4da-e2bad1535a6f 59741-116 HUMAN OTC DRUG Tussin DM Guaifenesin and Dextromethorphan Hydrobromide SOLUTION ORAL 20040101 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 59741-119_487518cc-037f-4ba7-9fd0-00505d7b5eee 59741-119 HUMAN OTC DRUG Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20140516 OTC MONOGRAPH FINAL part336 Bio-Pharm, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 59741-119_d0006a72-a645-4c73-b5ff-87fbf8b599a7 59741-119 HUMAN OTC DRUG Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20071206 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 59741-193_7859f14f-c019-4154-a55f-a4bffee3b872 59741-193 HUMAN OTC DRUG Assured Childrens Cold and Cough Brompheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride LIQUID ORAL 20111101 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL E 20171231 59741-201_e16635a2-9911-4b4f-988a-e9a3d916d2d6 59741-201 HUMAN OTC DRUG Assured Day time Cold and Cough Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20111101 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 59741-202_a17de757-a36d-4e40-aca8-ec21fde27583 59741-202 HUMAN OTC DRUG Assured Night time Cold and Cough Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride LIQUID ORAL 20111101 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 59741-224_ae14c13c-13ce-4ad0-9d43-dfe774ebe808 59741-224 HUMAN OTC DRUG Chest Congestion Guaifenesin SOLUTION ORAL 20140516 OTC MONOGRAPH FINAL part341 Bio-Pharm, Inc. GUAIFENESIN 100 mg/5mL N 20181231 59741-246_00b41dd5-a26b-4daf-b6cc-946c66d6248e 59741-246 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen LIQUID ORAL 20150220 OTC MONOGRAPH NOT FINAL part343 Bio-Pharm, Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 59741-262_da57f682-8c89-4396-857e-6b73cd0ff5dd 59741-262 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION ORAL 20170307 ANDA ANDA204765 Bio-Pharm, Inc. HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 59741-267_6133647b-ee80-4151-aee1-955fe2ae1661 59741-267 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE HYDROCODONE BITARTRATE CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE ORAL SOLUTION ORAL 20170516 ANDA ANDA206660 Bio-Pharm, Inc. HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 4; 60 mg/5mL; mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] CII N 20181231 59741-301_99820bf3-df4a-49e2-b92d-14648c03080d 59741-301 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate Hydrocortisone Acetate SUPPOSITORY RECTAL 20180115 UNAPPROVED DRUG OTHER Bio-Pharm, Inc. HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 59746-001_2f2c1f08-1661-4088-ba2f-f9dc32bc25bb 59746-001 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 JUBILANT CADISTA PHARMACEUTICALS INC. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 59746-002_2f2c1f08-1661-4088-ba2f-f9dc32bc25bb 59746-002 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 JUBILANT CADISTA PHARMACEUTICALS INC. METHYLPREDNISOLONE 8 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 59746-003_2f2c1f08-1661-4088-ba2f-f9dc32bc25bb 59746-003 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 JUBILANT CADISTA PHARMACEUTICALS INC. METHYLPREDNISOLONE 16 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 59746-010_bfe031d8-1550-4620-9208-b49c6966bf7f 59746-010 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20101201 ANDA ANDA090839 Jubilant Cadista Pharmaceuticals Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 59746-015_2f2c1f08-1661-4088-ba2f-f9dc32bc25bb 59746-015 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 JUBILANT CADISTA PHARMACEUTICALS INC. METHYLPREDNISOLONE 32 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 59746-020_bfe031d8-1550-4620-9208-b49c6966bf7f 59746-020 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20101201 ANDA ANDA090839 Jubilant Cadista Pharmaceuticals Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 59746-030_bfe031d8-1550-4620-9208-b49c6966bf7f 59746-030 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20101201 ANDA ANDA090839 Jubilant Cadista Pharmaceuticals Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 59746-040_bfe031d8-1550-4620-9208-b49c6966bf7f 59746-040 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20101201 ANDA ANDA090839 Jubilant Cadista Pharmaceuticals Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 59746-050_bfe031d8-1550-4620-9208-b49c6966bf7f 59746-050 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20101201 ANDA ANDA090839 Jubilant Cadista Pharmaceuticals Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 59746-113_414d1ad7-5d7e-4515-9198-1b8fe2d1f397 59746-113 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 19980301 ANDA ANDA040268 JUBILANT CADISTA PHARMACEUTICALS INC. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 59746-115_414d1ad7-5d7e-4515-9198-1b8fe2d1f397 59746-115 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 19980301 ANDA ANDA040268 JUBILANT CADISTA PHARMACEUTICALS INC. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 59746-121_a70cfd39-1405-4fd7-b538-e9eed65c095c 59746-121 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20100604 ANDA ANDA040659 JUBILANT CADISTA PHARMACEUTICALS INC. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 59746-122_a70cfd39-1405-4fd7-b538-e9eed65c095c 59746-122 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 20100604 ANDA ANDA040659 JUBILANT CADISTA PHARMACEUTICALS INC. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 59746-171_190585fd-cd73-4dc5-b5a5-46decf086c5c 59746-171 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20050606 ANDA ANDA040611 JUBILANT CADISTA PHARMACEUTICALS INC. PREDNISONE 1 mg/1 N 20181231 59746-172_b7ff7572-acfa-4482-a3b5-18369f73171e 59746-172 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 JUBILANT CADISTA PHARMACEUTICALS INC. PREDNISONE 5 mg/1 N 20191231 59746-173_b7ff7572-acfa-4482-a3b5-18369f73171e 59746-173 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 JUBILANT CADISTA PHARMACEUTICALS INC. PREDNISONE 10 mg/1 N 20191231 59746-175_b7ff7572-acfa-4482-a3b5-18369f73171e 59746-175 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 JUBILANT CADISTA PHARMACEUTICALS INC. PREDNISONE 20 mg/1 N 20191231 59746-177_cad3a28c-244f-42be-83f3-89f8ad45482d 59746-177 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20060404 ANDA ANDA077563 Jubilant Cadista Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 59746-211_cad3a28c-244f-42be-83f3-89f8ad45482d 59746-211 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20060404 ANDA ANDA077563 Jubilant Cadista Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 59746-216_5ad2b080-e06c-8285-062a-4f380b525526 59746-216 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20130201 ANDA ANDA203253 Jubilant Cadista Pharmaceuticals Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 59746-217_5ad2b080-e06c-8285-062a-4f380b525526 59746-217 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20130201 ANDA ANDA203253 Jubilant Cadista Pharmaceuticals Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 59746-218_5ad2b080-e06c-8285-062a-4f380b525526 59746-218 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20130201 ANDA ANDA203253 Jubilant Cadista Pharmaceuticals Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 59746-245_f14981c5-c11e-4d13-8757-8bf3efd7f9a3 59746-245 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 JUBILANT CADISTA PHARMACEUTICALS INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 59746-246_f14981c5-c11e-4d13-8757-8bf3efd7f9a3 59746-246 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 JUBILANT CADISTA PHARMACEUTICALS INC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 59746-247_f14981c5-c11e-4d13-8757-8bf3efd7f9a3 59746-247 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 JUBILANT CADISTA PHARMACEUTICALS INC. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 59746-248_f14981c5-c11e-4d13-8757-8bf3efd7f9a3 59746-248 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 JUBILANT CADISTA PHARMACEUTICALS INC. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 59746-279_bc5aee07-b6b0-474d-8810-2e97e31cea2c 59746-279 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120912 ANDA ANDA202280 Jubilant Cadista Pharmaceuticals Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 59746-280_bc5aee07-b6b0-474d-8810-2e97e31cea2c 59746-280 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120912 ANDA ANDA202280 Jubilant Cadista Pharmaceuticals Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 59746-281_bc5aee07-b6b0-474d-8810-2e97e31cea2c 59746-281 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120912 ANDA ANDA202280 Jubilant Cadista Pharmaceuticals Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 59746-282_2f8b1e62-bbd7-402f-888a-ac4436630b98 59746-282 HUMAN PRESCRIPTION DRUG itraconazole Itraconazole Capsules CAPSULE ORAL 20170223 ANDA ANDA203445 Jubilant Cadista Pharmaceuticals Inc. ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 59746-283_3d0e0e12-6378-4087-9691-0996b9c8f57a 59746-283 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110901 ANDA ANDA090901 Jubilant Cadista Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 59746-284_3d0e0e12-6378-4087-9691-0996b9c8f57a 59746-284 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110901 ANDA ANDA090901 Jubilant Cadista Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 59746-285_1b07bb16-f676-67c0-b05a-0c48ad5a831a 59746-285 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride TABLET, CHEWABLE ORAL 20150219 ANDA ANDA091116 Jubilant Cadista Pharmaceuticals Inc. CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 59746-285_473d9d58-3d83-9b76-6e6a-aa5cc8c1e06d 59746-285 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride TABLET, CHEWABLE ORAL 20150219 ANDA ANDA091116 Jubilant Cadista Pharmaceuticals Inc. CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 59746-286_1b07bb16-f676-67c0-b05a-0c48ad5a831a 59746-286 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride TABLET, CHEWABLE ORAL 20150219 ANDA ANDA091116 Jubilant Cadista Pharmaceuticals Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 59746-286_473d9d58-3d83-9b76-6e6a-aa5cc8c1e06d 59746-286 HUMAN OTC DRUG cetirizine hydrochloride cetirizine hydrochloride TABLET, CHEWABLE ORAL 20150219 ANDA ANDA091116 Jubilant Cadista Pharmaceuticals Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 59746-306_c4dc4802-bd5e-4fc6-a2b0-a2a309d10c3e 59746-306 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120913 ANDA ANDA200221 Jubilant Cadista Pharmaceuticals Inc OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 59746-307_c4dc4802-bd5e-4fc6-a2b0-a2a309d10c3e 59746-307 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120913 ANDA ANDA200221 Jubilant Cadista Pharmaceuticals Inc OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 59746-308_c4dc4802-bd5e-4fc6-a2b0-a2a309d10c3e 59746-308 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120913 ANDA ANDA200221 Jubilant Cadista Pharmaceuticals Inc OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 59746-309_c4dc4802-bd5e-4fc6-a2b0-a2a309d10c3e 59746-309 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120913 ANDA ANDA200221 Jubilant Cadista Pharmaceuticals Inc OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 59746-311_ecb51227-e797-0b32-2e65-9378ed110802 59746-311 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20110320 ANDA ANDA200220 Jubilant Cadista Pharmaceuticals Inc. LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 59746-312_ecb51227-e797-0b32-2e65-9378ed110802 59746-312 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20110320 ANDA ANDA200220 Jubilant Cadista Pharmaceuticals Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 59746-313_23d3c911-8698-8221-a7ee-30eb2959b4af 59746-313 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131011 ANDA ANDA202775 Jubilant Cadista Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 59746-314_759d44ce-1c45-4d31-9409-7ea83cf2fb97 59746-314 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride extended-release tablets (XL) TABLET, EXTENDED RELEASE ORAL 20170630 ANDA ANDA207459 Jubilant Cadista Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 59746-315_7fd6e773-2ab2-23ef-3d91-7cdf152a55bd 59746-315 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131011 ANDA ANDA202774 Jubilant Cadista Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 59746-316_7fd6e773-2ab2-23ef-3d91-7cdf152a55bd 59746-316 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131011 ANDA ANDA202774 Jubilant Cadista Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 59746-317_7fd6e773-2ab2-23ef-3d91-7cdf152a55bd 59746-317 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131011 ANDA ANDA202774 Jubilant Cadista Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 59746-324_255482d1-62dc-b8ef-7a40-f26251b5cdf9 59746-324 HUMAN PRESCRIPTION DRUG valacyclovir hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120405 ANDA ANDA201506 Jubilant Cadista Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 59746-325_255482d1-62dc-b8ef-7a40-f26251b5cdf9 59746-325 HUMAN PRESCRIPTION DRUG valacyclovir hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120405 ANDA ANDA201506 Jubilant Cadista Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 59746-329_9a57d5a3-ff92-b1d0-b62a-a7155a916f2c 59746-329 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110529 ANDA ANDA090768 Jubilant Cadista Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 59746-330_9a57d5a3-ff92-b1d0-b62a-a7155a916f2c 59746-330 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110529 ANDA ANDA090768 Jubilant Cadista Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 59746-331_07ae2bf4-d9d9-f00c-246b-cfc4281425d7 59746-331 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride MEMANTINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20151014 ANDA ANDA091585 Jubilant Cadista Pharmaceuticals Inc. MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 59746-332_07ae2bf4-d9d9-f00c-246b-cfc4281425d7 59746-332 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride MEMANTINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20151014 ANDA ANDA091585 Jubilant Cadista Pharmaceuticals Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 59746-333_b98e81bb-f273-f006-59bc-ab3f0305444c 59746-333 HUMAN PRESCRIPTION DRUG Losartan potassium Tablets, 25 mg losartan potassium TABLET ORAL 20120918 ANDA ANDA201170 Jubilant Cadista Pharmaceuticals Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-334_b98e81bb-f273-f006-59bc-ab3f0305444c 59746-334 HUMAN PRESCRIPTION DRUG Losartan potassium Tablets, 50 mg losartan potassium TABLET ORAL 20120918 ANDA ANDA201170 Jubilant Cadista Pharmaceuticals Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-335_b98e81bb-f273-f006-59bc-ab3f0305444c 59746-335 HUMAN PRESCRIPTION DRUG Losartan potassium Tablets, 100 mg losartan potassium TABLET ORAL 20120918 ANDA ANDA201170 Jubilant Cadista Pharmaceuticals Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-337_18481037-9a9b-49c6-b137-0f108a8cdaf3 59746-337 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20121030 ANDA ANDA201845 JUBILANT CADISTA PHARMACEUTICALS INC. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 59746-338_18481037-9a9b-49c6-b137-0f108a8cdaf3 59746-338 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20121030 ANDA ANDA201845 JUBILANT CADISTA PHARMACEUTICALS INC. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 59746-339_18481037-9a9b-49c6-b137-0f108a8cdaf3 59746-339 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 20121030 ANDA ANDA201845 JUBILANT CADISTA PHARMACEUTICALS INC. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 59746-346_b9433654-efeb-47e5-a5ab-2fb1c0544df8 59746-346 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20170825 ANDA ANDA205215 Jubilant Cadista Pharmaceuticals Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59746-347_b9433654-efeb-47e5-a5ab-2fb1c0544df8 59746-347 HUMAN PRESCRIPTION DRUG Indomethacin indomethacin CAPSULE ORAL 20170825 ANDA ANDA205215 Jubilant Cadista Pharmaceuticals Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59746-348_fcc65f5b-d0d2-4a03-ac97-45350961ea19 59746-348 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET ORAL 20131127 ANDA ANDA203150 Jubilant Cadista Pharmaceuticals Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 59746-358_8b5d28c1-a246-ebe7-f79e-c81ad9b20629 59746-358 HUMAN PRESCRIPTION DRUG Montelukast sodium chewable montelukast sodium TABLET, CHEWABLE ORAL 20150228 ANDA ANDA203795 Jubilant Cadista Pharmaceuticals Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 59746-359_8b5d28c1-a246-ebe7-f79e-c81ad9b20629 59746-359 HUMAN PRESCRIPTION DRUG Montelukast sodium chewable montelukast sodium TABLET, CHEWABLE ORAL 20150228 ANDA ANDA203795 Jubilant Cadista Pharmaceuticals Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 59746-360_c69c2d8c-286e-40c1-be81-9da93af90cee 59746-360 HUMAN PRESCRIPTION DRUG valsartan valsartan TABLET ORAL 20150105 ANDA ANDA203536 Jubilant Cadista Pharmaceuticals Inc. VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-361_c69c2d8c-286e-40c1-be81-9da93af90cee 59746-361 HUMAN PRESCRIPTION DRUG valsartan valsartan TABLET ORAL 20150105 ANDA ANDA203536 Jubilant Cadista Pharmaceuticals Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-362_c69c2d8c-286e-40c1-be81-9da93af90cee 59746-362 HUMAN PRESCRIPTION DRUG valsartan valsartan TABLET ORAL 20150105 ANDA ANDA203536 Jubilant Cadista Pharmaceuticals Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-363_c69c2d8c-286e-40c1-be81-9da93af90cee 59746-363 HUMAN PRESCRIPTION DRUG valsartan valsartan TABLET ORAL 20150105 ANDA ANDA203536 Jubilant Cadista Pharmaceuticals Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-369_24228335-1990-d655-bb50-ad7472e20cf5 59746-369 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160819 ANDA ANDA203983 Jubilant Cadista Pharmaceuticals Inc. FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 59746-370_24228335-1990-d655-bb50-ad7472e20cf5 59746-370 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160819 ANDA ANDA203983 Jubilant Cadista Pharmaceuticals Inc. FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 59746-371_24228335-1990-d655-bb50-ad7472e20cf5 59746-371 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160819 ANDA ANDA203983 Jubilant Cadista Pharmaceuticals Inc. FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 59746-379_c0542248-39d7-404f-9532-52195b309cb2 59746-379 HUMAN PRESCRIPTION DRUG Indomethacin extended-release Indomethacin extended-release CAPSULE ORAL 20151005 ANDA ANDA202706 Jubilant Cadista Pharmaceuticals Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59746-382_9864604f-6e3b-4ec2-a8dd-1daa68e14931 59746-382 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20080211 ANDA ANDA078391 JUBILANT CADISTA PHARMACEUTICALS INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 59746-383_e754697b-2435-4d15-b6ce-f5443b960fba 59746-383 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Jubilant Cadista Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59746-384_e754697b-2435-4d15-b6ce-f5443b960fba 59746-384 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Jubilant Cadista Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59746-385_e754697b-2435-4d15-b6ce-f5443b960fba 59746-385 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Jubilant Cadista Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59746-386_e754697b-2435-4d15-b6ce-f5443b960fba 59746-386 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Jubilant Cadista Pharmaceuticals Inc. TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59746-414_cb87717a-d3fd-40e1-b358-fa0830173dd7 59746-414 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET ORAL 20130301 ANDA ANDA203252 Jubilant Cadista Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 59746-415_cb87717a-d3fd-40e1-b358-fa0830173dd7 59746-415 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET ORAL 20140301 ANDA ANDA203252 Jubilant Cadista Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 59746-428_7224a28d-4515-318e-6234-6d01a1355c86 59746-428 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA207062 Jubilant Cadista Pharmaceuticals Inc. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 59746-429_7224a28d-4515-318e-6234-6d01a1355c86 59746-429 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA207062 Jubilant Cadista Pharmaceuticals Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 59746-430_7224a28d-4515-318e-6234-6d01a1355c86 59746-430 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA207062 Jubilant Cadista Pharmaceuticals Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 59746-431_7224a28d-4515-318e-6234-6d01a1355c86 59746-431 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA207062 Jubilant Cadista Pharmaceuticals Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 59746-432_2687a801-fb6c-c055-1900-99ce5d0497bd 59746-432 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20141120 ANDA ANDA202279 Jubilant Cadista Pharmaceuticals Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 59746-433_2687a801-fb6c-c055-1900-99ce5d0497bd 59746-433 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20141120 ANDA ANDA202279 Jubilant Cadista Pharmaceuticals Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 59746-439_659007d2-bf27-f478-1201-81e7c39a3e8a 59746-439 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20160822 ANDA ANDA204164 Jubilant Cadista Pharmaceuticals Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-440_659007d2-bf27-f478-1201-81e7c39a3e8a 59746-440 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20160822 ANDA ANDA204164 Jubilant Cadista Pharmaceuticals Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-441_659007d2-bf27-f478-1201-81e7c39a3e8a 59746-441 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20160822 ANDA ANDA204164 Jubilant Cadista Pharmaceuticals Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-445_b61853c9-a975-fd9c-1820-2ccc6b55320d 59746-445 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20140301 ANDA ANDA203334 Jubilant Cadista Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 59746-446_b61853c9-a975-fd9c-1820-2ccc6b55320d 59746-446 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20120301 ANDA ANDA203334 Jubilant Cadista Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 59746-447_d18cee5f-695b-c4e1-e9fe-314e160e2200 59746-447 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET ORAL 20150224 ANDA ANDA203534 Jubilant Cadista Pharmaceuticals Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-448_d18cee5f-695b-c4e1-e9fe-314e160e2200 59746-448 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET ORAL 20150224 ANDA ANDA203534 Jubilant Cadista Pharmaceuticals Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-449_d18cee5f-695b-c4e1-e9fe-314e160e2200 59746-449 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET ORAL 20150224 ANDA ANDA203534 Jubilant Cadista Pharmaceuticals Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-457_29fa27d9-ad4f-402a-a222-538688fc7fd9 59746-457 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20151120 ANDA ANDA205528 Jubilant Cadista Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 59746-458_29fa27d9-ad4f-402a-a222-538688fc7fd9 59746-458 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20151120 ANDA ANDA205528 Jubilant Cadista Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 59746-459_29fa27d9-ad4f-402a-a222-538688fc7fd9 59746-459 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20151120 ANDA ANDA205528 Jubilant Cadista Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 59746-460_29fa27d9-ad4f-402a-a222-538688fc7fd9 59746-460 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20151120 ANDA ANDA205528 Jubilant Cadista Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 59746-461_7769d4f5-30f2-e78b-ddc1-00a973a3c979 59746-461 HUMAN PRESCRIPTION DRUG Zolmitriptan OD Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20150917 ANDA ANDA202956 Jubilant Cadista Pharmaceuticals Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 59746-462_7769d4f5-30f2-e78b-ddc1-00a973a3c979 59746-462 HUMAN PRESCRIPTION DRUG Zolmitriptan OD Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20150917 ANDA ANDA202956 Jubilant Cadista Pharmaceuticals Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 59746-463_6cd8ab6b-803e-44ef-9e95-c8532e5f8751 59746-463 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20160401 ANDA ANDA205482 Jubilant Cadista Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-465_6cd8ab6b-803e-44ef-9e95-c8532e5f8751 59746-465 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20160401 ANDA ANDA205482 Jubilant Cadista Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-466_6cd8ab6b-803e-44ef-9e95-c8532e5f8751 59746-466 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20160401 ANDA ANDA205482 Jubilant Cadista Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-513_e9c06b04-0a9e-a821-787b-1841ba30ca38 59746-513 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121202 ANDA ANDA203613 Jubilant Cadista Pharmaceuticals Inc. LEVOFLOXACIN 250 mg/1 N 20181231 59746-514_e9c06b04-0a9e-a821-787b-1841ba30ca38 59746-514 HUMAN PRESCRIPTION DRUG Levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121202 ANDA ANDA203613 Jubilant Cadista Pharmaceuticals Inc. LEVOFLOXACIN 500 mg/1 E 20171231 59746-516_adcd4b7e-b4f5-49f3-9e39-2d126dd76a7d 59746-516 HUMAN PRESCRIPTION DRUG darifenacin darifenacin hydrobromide TABLET, EXTENDED RELEASE ORAL 20161012 ANDA ANDA205550 Jubilant Cadista Pharmaceuticals Inc. DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 59746-517_adcd4b7e-b4f5-49f3-9e39-2d126dd76a7d 59746-517 HUMAN PRESCRIPTION DRUG darifenacin darifenacin hydrobromide TABLET, EXTENDED RELEASE ORAL 20161012 ANDA ANDA205550 Jubilant Cadista Pharmaceuticals Inc. DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 59746-526_660f89b1-ff32-4d61-aa48-56d9e6c15dce 59746-526 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil TABLET, FILM COATED ORAL 20170515 ANDA ANDA207450 Jubilant Cadista Pharmaceuticals Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-527_660f89b1-ff32-4d61-aa48-56d9e6c15dce 59746-527 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil TABLET, FILM COATED ORAL 20170515 ANDA ANDA207450 Jubilant Cadista Pharmaceuticals Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-528_660f89b1-ff32-4d61-aa48-56d9e6c15dce 59746-528 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil TABLET, FILM COATED ORAL 20170515 ANDA ANDA207450 Jubilant Cadista Pharmaceuticals Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-529_660f89b1-ff32-4d61-aa48-56d9e6c15dce 59746-529 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil TABLET, FILM COATED ORAL 20170515 ANDA ANDA207450 Jubilant Cadista Pharmaceuticals Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 59746-543_a0cc4892-c19e-49b8-93d2-5e1628ef3bcf 59746-543 HUMAN PRESCRIPTION DRUG Citalopram citalopram hydrobromide TABLET, FILM COATED ORAL 20151223 ANDA ANDA205407 Jubilant Cadista Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 59746-544_a0cc4892-c19e-49b8-93d2-5e1628ef3bcf 59746-544 HUMAN PRESCRIPTION DRUG Citalopram citalopram hydrobromide TABLET, FILM COATED ORAL 20151223 ANDA ANDA205407 Jubilant Cadista Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 59746-546_a0cc4892-c19e-49b8-93d2-5e1628ef3bcf 59746-546 HUMAN PRESCRIPTION DRUG Citalopram citalopram hydrobromide TABLET, FILM COATED ORAL 20151223 ANDA ANDA205407 Jubilant Cadista Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 59746-561_71906d0e-d0e3-433d-a231-c6f2ed82bcbb 59746-561 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20170404 ANDA ANDA207061 Jubilant Cadista Pharmaceuticals Inc. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59746-562_71906d0e-d0e3-433d-a231-c6f2ed82bcbb 59746-562 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20170404 ANDA ANDA207061 Jubilant Cadista Pharmaceuticals Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59746-563_71906d0e-d0e3-433d-a231-c6f2ed82bcbb 59746-563 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20170404 ANDA ANDA207061 Jubilant Cadista Pharmaceuticals Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59746-564_71906d0e-d0e3-433d-a231-c6f2ed82bcbb 59746-564 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20170404 ANDA ANDA207061 Jubilant Cadista Pharmaceuticals Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59746-591_2c48c7ef-8655-4ca4-9f85-e8a5d5e33c98 59746-591 HUMAN PRESCRIPTION DRUG levetiracetam Levetiracetam Injection INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160602 ANDA ANDA206838 Jubilant Cadista Pharmaceuticals Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 59746-668_500262ae-3bfb-49da-b349-676a581f23e2 59746-668 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET, EXTENDED RELEASE ORAL 20180129 ANDA ANDA210338 Jubilant Cadista Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .01 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 59746-670_b384b1a9-6301-4d3f-a6f1-4deb5f58e6e6 59746-670 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE ORAL 20170804 ANDA ANDA209605 Jubilant Cadista Pharmaceuticals Inc. TIZANIDINE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 59746-671_b384b1a9-6301-4d3f-a6f1-4deb5f58e6e6 59746-671 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE ORAL 20170804 ANDA ANDA209605 Jubilant Cadista Pharmaceuticals Inc. TIZANIDINE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 59746-672_b384b1a9-6301-4d3f-a6f1-4deb5f58e6e6 59746-672 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE ORAL 20170804 ANDA ANDA209605 Jubilant Cadista Pharmaceuticals Inc. TIZANIDINE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 59746-705_fc3b60c2-7da9-41ac-9385-ca062af5f360 59746-705 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20150601 ANDA ANDA205085 Jubilant Cadista Pharmaceuticals Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 59746-735_cad3a28c-244f-42be-83f3-89f8ad45482d 59746-735 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20171009 ANDA ANDA077563 Jubilant Cadista Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 59746-742_c3d43d0f-4d7d-4ed6-9cda-4eda85217a3d 59746-742 HUMAN PRESCRIPTION DRUG Clarithromycin 250 mg Clarithromycin TABLET, FILM COATED ORAL 20161012 ANDA ANDA202710 Jubilant Cadista Pharmaceuticals Inc. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 59746-743_c3d43d0f-4d7d-4ed6-9cda-4eda85217a3d 59746-743 HUMAN PRESCRIPTION DRUG Clarithromycin 500 mg Clarithromycin TABLET, FILM COATED ORAL 20161012 ANDA ANDA202710 Jubilant Cadista Pharmaceuticals Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 59746-758_759d44ce-1c45-4d31-9409-7ea83cf2fb97 59746-758 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride extended-release tablets (XL) TABLET, EXTENDED RELEASE ORAL 20170630 ANDA ANDA207459 Jubilant Cadista Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 59752-0124_ea800b91-abb2-471f-b5b3-55b8f74a587f 59752-0124 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20050510 UNAPPROVED MEDICAL GAS Buffalo Wheelchair dba Naples Oxygen OXYGEN 99 L/100L E 20171231 59754-002_3c2687c5-ce06-4322-8977-eccd3fea3ff4 59754-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20100801 UNAPPROVED MEDICAL GAS Specialty Gases of America LLC NITROGEN 99 L/100L E 20171231 59756-511_a5db0cca-9cd0-40ac-88f4-3b829e41782e 59756-511 HUMAN OTC DRUG GREAT II LOTIONIZED ANTISEPTIC CHLOROXYLENOL SOAP TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333E MEYER LABORATORY CHLOROXYLENOL 3 g/1000mL E 20171231 59759-557_9019cfc2-7ca3-41c3-9020-9a5c4a235630 59759-557 HUMAN OTC DRUG SOFT SADDLE CHLOROXYLENOL SOAP TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part333E BAUMANN PAPER COMPANY CHLOROXYLENOL 2.5 g/1000mL E 20171231 59760-001_4a66daad-0c7c-4788-9fca-d097cdc17d0e 59760-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20101130 NDA NDA206023 Aeroflow, Inc dba Aeroflow Healthcare OXYGEN 99 L/100L N 20181231 59762-0016_200fdde1-a7ce-4344-8c69-3826a55608ed 59762-0016 HUMAN PRESCRIPTION DRUG clindamycin palmitate hydrochloride clindamycin palmitate hydrochloride SOLUTION ORAL 19860407 ANDA ANDA062644 Greenstone LLC CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 59762-0028_e3f76eda-05f9-42c8-b26a-d89600a84284 59762-0028 HUMAN PRESCRIPTION DRUG Diclofenac sodium and Misoprostol Diclofenac sodium and Misoprostol TABLET, FILM COATED ORAL 20121101 NDA AUTHORIZED GENERIC NDA020607 Greenstone LLC DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59762-0029_e3f76eda-05f9-42c8-b26a-d89600a84284 59762-0029 HUMAN PRESCRIPTION DRUG Diclofenac sodium and Misoprostol Diclofenac sodium and Misoprostol TABLET, FILM COATED ORAL 20121101 NDA AUTHORIZED GENERIC NDA020607 Greenstone LLC DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 59762-0033_af8fe1ee-3fcf-404e-9091-d088a9d5029f 59762-0033 HUMAN PRESCRIPTION DRUG Sildenafil sildenafil citrate TABLET, FILM COATED ORAL 20120927 NDA AUTHORIZED GENERIC NDA021845 Greenstone LLC SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 59762-0034_35bae01e-4b1f-4c9d-91de-3ce09500d864 59762-0034 HUMAN PRESCRIPTION DRUG Sildenafil Citrate sildenafil citrate TABLET, FILM COATED ORAL 20171201 NDA NDA020895 Greenstone LLC SILDENAFIL CITRATE 25 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 59762-0035_35bae01e-4b1f-4c9d-91de-3ce09500d864 59762-0035 HUMAN PRESCRIPTION DRUG Sildenafil Citrate sildenafil citrate TABLET, FILM COATED ORAL 20171201 NDA NDA020895 Greenstone LLC SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 59762-0036_35bae01e-4b1f-4c9d-91de-3ce09500d864 59762-0036 HUMAN PRESCRIPTION DRUG Sildenafil Citrate sildenafil citrate TABLET, FILM COATED ORAL 20171201 NDA NDA020895 Greenstone LLC SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 59762-0037_0f7c3696-cc1c-413e-bb30-9f18abb27fa1 59762-0037 HUMAN PRESCRIPTION DRUG Dofetilide dofetilide CAPSULE ORAL 20160501 NDA NDA020931 Greenstone LLC DOFETILIDE .125 mg/1 Antiarrhythmic [EPC] N 20181231 59762-0038_0f7c3696-cc1c-413e-bb30-9f18abb27fa1 59762-0038 HUMAN PRESCRIPTION DRUG Dofetilide dofetilide CAPSULE ORAL 20160501 NDA NDA020931 Greenstone LLC DOFETILIDE .25 mg/1 Antiarrhythmic [EPC] N 20181231 59762-0039_0f7c3696-cc1c-413e-bb30-9f18abb27fa1 59762-0039 HUMAN PRESCRIPTION DRUG Dofetilide dofetilide CAPSULE ORAL 20160501 NDA NDA020931 Greenstone LLC DOFETILIDE .5 mg/1 Antiarrhythmic [EPC] N 20181231 59762-0047_1f1c0008-a089-4171-98e3-ea48de3faf6a 59762-0047 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Extended Release tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20160122 NDA NDA021228 Greenstone LLC TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 59762-0048_1f1c0008-a089-4171-98e3-ea48de3faf6a 59762-0048 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Extended Release tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20141230 NDA NDA021228 Greenstone LLC TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 59762-0049_d27cd8eb-c953-4720-96e9-72ed32567613 59762-0049 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20130325 NDA AUTHORIZED GENERIC NDA011153 Greenstone LLC METHYLPREDNISOLONE 8 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59762-0050_d27cd8eb-c953-4720-96e9-72ed32567613 59762-0050 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20130325 NDA AUTHORIZED GENERIC NDA011153 Greenstone LLC METHYLPREDNISOLONE 16 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59762-0051_d27cd8eb-c953-4720-96e9-72ed32567613 59762-0051 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20130325 NDA AUTHORIZED GENERIC NDA011153 Greenstone LLC METHYLPREDNISOLONE 32 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59762-0057_d78d51a9-9fda-47ee-8af4-89cd979feb69 59762-0057 HUMAN PRESCRIPTION DRUG Alprazolam XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA AUTHORIZED GENERIC NDA021434 Greenstone LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 59762-0059_d78d51a9-9fda-47ee-8af4-89cd979feb69 59762-0059 HUMAN PRESCRIPTION DRUG Alprazolam XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA AUTHORIZED GENERIC NDA021434 Greenstone LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 59762-0066_d78d51a9-9fda-47ee-8af4-89cd979feb69 59762-0066 HUMAN PRESCRIPTION DRUG Alprazolam XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA AUTHORIZED GENERIC NDA021434 Greenstone LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 59762-0068_d78d51a9-9fda-47ee-8af4-89cd979feb69 59762-0068 HUMAN PRESCRIPTION DRUG Alprazolam XR alprazolam TABLET, EXTENDED RELEASE ORAL 20030117 NDA AUTHORIZED GENERIC NDA021434 Greenstone LLC ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 59762-0073_af689e42-b378-453e-8453-ff71595a0a29 59762-0073 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20130220 NDA AUTHORIZED GENERIC NDA008697 Greenstone LLC HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59762-0074_af689e42-b378-453e-8453-ff71595a0a29 59762-0074 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20130220 NDA AUTHORIZED GENERIC NDA008697 Greenstone LLC HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59762-0075_af689e42-b378-453e-8453-ff71595a0a29 59762-0075 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20130220 NDA AUTHORIZED GENERIC NDA008697 Greenstone LLC HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 59762-0104_4340e6e8-ef35-4ede-8baa-819ec1ac39e9 59762-0104 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET, DELAYED RELEASE ORAL 20050505 NDA AUTHORIZED GENERIC NDA007073 Greenstone LLC SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 59762-0119_ce9f36a4-ab8a-4ff3-87fb-496268212dc8 59762-0119 HUMAN PRESCRIPTION DRUG phenelzine sulfate Phenelzine Sulfate TABLET, FILM COATED ORAL 19610609 NDA NDA011909 Greenstone LLC PHENELZINE SULFATE 15 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] E 20171231 59762-0122_0ef37a9c-9256-5e5c-9190-c656d368297d 59762-0122 HUMAN PRESCRIPTION DRUG Trandolapril and Verapamil Hydrochloride ER Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150225 NDA NDA020591 Greenstone LLC TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 59762-0131_3682e456-8259-4f9c-80ca-738402f7ddba 59762-0131 HUMAN PRESCRIPTION DRUG SILVER SULFADIAZINE silver sulfadiazine CREAM TOPICAL 20180115 NDA AUTHORIZED GENERIC NDA017381 Greenstone LLC SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20191231 59762-0132_0ef37a9c-9256-5e5c-9190-c656d368297d 59762-0132 HUMAN PRESCRIPTION DRUG Trandolapril and Verapamil Hydrochloride ER Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150225 NDA NDA020591 Greenstone LLC TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 59762-0140_a1c766cf-1f6c-4044-b208-c3ae31ff68f8 59762-0140 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20140303 NDA NDA018147 Greenstone LLC PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59762-0142_0ef37a9c-9256-5e5c-9190-c656d368297d 59762-0142 HUMAN PRESCRIPTION DRUG Trandolapril and Verapamil Hydrochloride ER Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150225 NDA NDA020591 Greenstone LLC TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 180 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 59762-0145_a1c766cf-1f6c-4044-b208-c3ae31ff68f8 59762-0145 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20140303 NDA NDA018147 Greenstone LLC PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59762-0152_0ef37a9c-9256-5e5c-9190-c656d368297d 59762-0152 HUMAN PRESCRIPTION DRUG Trandolapril and Verapamil Hydrochloride ER Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150225 20180228 NDA NDA020591 Greenstone LLC TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 1; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 59762-0155_3d8bcc8c-dfbf-42a6-8623-47c223b3db13 59762-0155 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130128 NDA AUTHORIZED GENERIC NDA020702 Greenstone LLC ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 59762-0156_3d8bcc8c-dfbf-42a6-8623-47c223b3db13 59762-0156 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130128 NDA AUTHORIZED GENERIC NDA020702 Greenstone LLC ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 59762-0157_3d8bcc8c-dfbf-42a6-8623-47c223b3db13 59762-0157 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130128 NDA AUTHORIZED GENERIC NDA020702 Greenstone LLC ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 59762-0158_3d8bcc8c-dfbf-42a6-8623-47c223b3db13 59762-0158 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130128 NDA AUTHORIZED GENERIC NDA020702 Greenstone LLC ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 59762-0170_ed9b3b5f-bd2f-4bcd-8930-5c2230512f72 59762-0170 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20140121 NDA AUTHORIZED GENERIC NDA020771 Greenstone LLC TOLTERODINE TARTRATE 1 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 59762-0180_855e61df-8031-4fae-b224-9493a7e8f9be 59762-0180 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110602 NDA AUTHORIZED GENERIC NDA020699 Greenstone LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 59762-0181_855e61df-8031-4fae-b224-9493a7e8f9be 59762-0181 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110602 NDA AUTHORIZED GENERIC NDA020699 Greenstone LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 59762-0182_855e61df-8031-4fae-b224-9493a7e8f9be 59762-0182 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110602 NDA AUTHORIZED GENERIC NDA020699 Greenstone LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 59762-0220_256cda37-e3ae-4809-8b25-0a5477202f2c 59762-0220 HUMAN PRESCRIPTION DRUG quinapril hydrochloride and hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19991228 NDA AUTHORIZED GENERIC NDA020125 Greenstone LLC QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 59762-0222_256cda37-e3ae-4809-8b25-0a5477202f2c 59762-0222 HUMAN PRESCRIPTION DRUG quinapril hydrochloride and hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19991228 NDA AUTHORIZED GENERIC NDA020125 Greenstone LLC QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 59762-0223_256cda37-e3ae-4809-8b25-0a5477202f2c 59762-0223 HUMAN PRESCRIPTION DRUG quinapril hydrochloride and hydrochlorothiazide quinapril hydrochloride and hydrochlorothiazide TABLET, FILM COATED ORAL 19991228 NDA AUTHORIZED GENERIC NDA020125 Greenstone LLC QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 59762-0250_5f802909-cb08-4bca-b6ab-432c61e32280 59762-0250 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride ODT DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING ORAL 20041018 20180701 NDA NDA021720 Greenstone LLC DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 59762-0260_6c6b6728-09da-468c-be70-7d517f550349 59762-0260 HUMAN PRESCRIPTION DRUG Colestipol Hydrochloride Colestipol Hydrochloride GRANULE, FOR SUSPENSION ORAL 19770404 NDA AUTHORIZED GENERIC NDA017563 Greenstone LLC COLESTIPOL HYDROCHLORIDE 5 g/5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 59762-0333_eab85803-0534-4d8a-9f7b-0ef7771ecc44 59762-0333 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION OPHTHALMIC 19950320 NDA AUTHORIZED GENERIC NDA020597 Greenstone LLC LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 59762-0401_3a43d050-8824-4b7e-ba20-1c94d6348f03 59762-0401 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20170925 NDA AUTHORIZED GENERIC NDA018333 Greenstone LLC SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 59762-0408_bacf05ab-3d8b-414e-9d9d-63420adf5ae3 59762-0408 HUMAN PRESCRIPTION DRUG ATAZANAVIR ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20180102 NDA AUTHORIZED GENERIC NDA059762 Greenstone LLC ATAZANAVIR SULFATE 150 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 59762-0409_bacf05ab-3d8b-414e-9d9d-63420adf5ae3 59762-0409 HUMAN PRESCRIPTION DRUG ATAZANAVIR ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20180102 NDA AUTHORIZED GENERIC NDA059762 Greenstone LLC ATAZANAVIR SULFATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 59762-0410_bacf05ab-3d8b-414e-9d9d-63420adf5ae3 59762-0410 HUMAN PRESCRIPTION DRUG ATAZANAVIR ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20180102 NDA AUTHORIZED GENERIC NDA059762 Greenstone LLC ATAZANAVIR SULFATE 300 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 59762-0450_786a1764-f1d2-4d63-a5ea-388d85f63410 59762-0450 HUMAN PRESCRIPTION DRUG Colestipol Hydrochloride Colestipol Hydrochloride TABLET ORAL 19940719 NDA AUTHORIZED GENERIC NDA020222 Greenstone LLC COLESTIPOL HYDROCHLORIDE 1 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 59762-0489_1c44c120-e986-49e4-8f65-25d945d04093 59762-0489 HUMAN PRESCRIPTION DRUG NITROGLYCERIN nitroglycerin TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20160826 NDA AUTHORIZED GENERIC NDA021134 Greenstone LLC NITROGLYCERIN .6 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 59762-0531_67a0516a-ab81-4b74-9763-69ec3756aa2b 59762-0531 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20121009 NDA AUTHORIZED GENERIC NDA008762 Greenstone LLC PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 59762-0540_f3253ec1-93d8-489c-85d4-cf0a6ee009b9 59762-0540 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20130529 NDA AUTHORIZED GENERIC NDA020329 Greenstone LLC GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 59762-0541_f3253ec1-93d8-489c-85d4-cf0a6ee009b9 59762-0541 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20130529 NDA AUTHORIZED GENERIC NDA020329 Greenstone LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 59762-0542_f3253ec1-93d8-489c-85d4-cf0a6ee009b9 59762-0542 HUMAN PRESCRIPTION DRUG Glipizide XL glipizide TABLET, EXTENDED RELEASE ORAL 20130529 NDA AUTHORIZED GENERIC NDA020329 Greenstone LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 59762-0702_9efe0b54-8df2-432c-9451-b00127d63ffe 59762-0702 HUMAN PRESCRIPTION DRUG mycophenolate mofetil mycophenolate mofetil TABLET, FILM COATED ORAL 20100611 ANDA ANDA090456 Greenstone LLC MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] E 20171231 59762-0703_9efe0b54-8df2-432c-9451-b00127d63ffe 59762-0703 HUMAN PRESCRIPTION DRUG mycophenolate mofetil mycophenolate mofetil CAPSULE ORAL 20100611 ANDA ANDA090055 Greenstone LLC MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] E 20171231 59762-0800_ed9b3b5f-bd2f-4bcd-8930-5c2230512f72 59762-0800 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20140121 NDA AUTHORIZED GENERIC NDA020771 Greenstone LLC TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 59762-0810_92a85ac7-4cec-4a6d-9b0d-d92360c7cc95 59762-0810 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 20140428 NDA AUTHORIZED GENERIC NDA018063 Greenstone LLC NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 59762-0811_92a85ac7-4cec-4a6d-9b0d-d92360c7cc95 59762-0811 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 20140428 NDA AUTHORIZED GENERIC NDA018063 Greenstone LLC NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 59762-0812_92a85ac7-4cec-4a6d-9b0d-d92360c7cc95 59762-0812 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 20140428 NDA AUTHORIZED GENERIC NDA018063 Greenstone LLC NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 59762-0925_2ac628a8-1424-4a87-b28d-2dc91305a495 59762-0925 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20020501 NDA NDA021266 Greenstone LLC VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 59762-0930_2ac628a8-1424-4a87-b28d-2dc91305a495 59762-0930 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20020501 NDA NDA021266 Greenstone LLC VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 59762-0934_2ac628a8-1424-4a87-b28d-2dc91305a495 59762-0934 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20020501 NDA NDA021266 Greenstone LLC VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 59762-0935_2ac628a8-1424-4a87-b28d-2dc91305a495 59762-0935 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole POWDER, FOR SUSPENSION ORAL 20131216 NDA NDA021630 Greenstone LLC VORICONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 59762-0936_2ac628a8-1424-4a87-b28d-2dc91305a495 59762-0936 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20020501 NDA NDA021266 Greenstone LLC VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 59762-1001_62fa522f-54f1-40e7-af5c-2408ce9e7176 59762-1001 HUMAN PRESCRIPTION DRUG Sirolimus SIROLIMUS TABLET, SUGAR COATED ORAL 20140107 NDA AUTHORIZED GENERIC NDA021110 Greenstone LLC SIROLIMUS .5 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 59762-1002_62fa522f-54f1-40e7-af5c-2408ce9e7176 59762-1002 HUMAN PRESCRIPTION DRUG Sirolimus SIROLIMUS TABLET, SUGAR COATED ORAL 20141027 NDA AUTHORIZED GENERIC NDA021110 Greenstone LLC SIROLIMUS 1 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 59762-1003_62fa522f-54f1-40e7-af5c-2408ce9e7176 59762-1003 HUMAN PRESCRIPTION DRUG Sirolimus SIROLIMUS TABLET, SUGAR COATED ORAL 20141027 NDA AUTHORIZED GENERIC NDA021110 Greenstone LLC SIROLIMUS 2 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 59762-1004_6781ba59-f21a-4c40-a4bc-7abe0061ec91 59762-1004 HUMAN PRESCRIPTION DRUG nifedipine nifedipine CAPSULE ORAL 20130325 NDA AUTHORIZED GENERIC NDA018482 Greenstone LLC NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 59762-1005_9607e6d9-7616-4e67-b26b-399aa9c9dbc3 59762-1005 HUMAN PRESCRIPTION DRUG Cabergoline cabergoline TABLET ORAL 20140922 NDA AUTHORIZED GENERIC NDA020664 Greenstone LLC CABERGOLINE .5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 59762-1061_42b872b8-9b0b-43ce-9f38-271af69d20c0 59762-1061 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20130227 NDA AUTHORIZED GENERIC NDA012462 Greenstone LLC DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 59762-1210_7f87b32e-0bf7-427b-a33e-ef1df2e3d3ce 59762-1210 HUMAN PRESCRIPTION DRUG Desvenlafaxine Succinate desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20170301 NDA AUTHORIZED GENERIC NDA021992 Greenstone LLC DESVENLAFAXINE SUCCINATE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 59762-1211_7f87b32e-0bf7-427b-a33e-ef1df2e3d3ce 59762-1211 HUMAN PRESCRIPTION DRUG Desvenlafaxine Succinate desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20170301 NDA AUTHORIZED GENERIC NDA021992 Greenstone LLC DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 59762-1222_7f87b32e-0bf7-427b-a33e-ef1df2e3d3ce 59762-1222 HUMAN PRESCRIPTION DRUG Desvenlafaxine Succinate desvenlafaxine succinate TABLET, EXTENDED RELEASE ORAL 20170301 NDA AUTHORIZED GENERIC NDA021992 Greenstone LLC DESVENLAFAXINE SUCCINATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 59762-1307_7826f6e0-d68e-460c-b734-7317ec18db60 59762-1307 HUMAN PRESCRIPTION DRUG Linezolid linezolid TABLET, FILM COATED ORAL 20151012 NDA NDA021130 Greenstone LLC LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 59762-1308_4840e719-eb08-4f57-a1be-b40991acc78a 59762-1308 HUMAN PRESCRIPTION DRUG Linezolid linezolid SUSPENSION ORAL 20150518 NDA AUTHORIZED GENERIC NDA021132 Greenstone LLC LINEZOLID 100 mg/5mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 59762-1350_5270be0c-16d7-4b04-b58e-afcc8010619f 59762-1350 HUMAN PRESCRIPTION DRUG Rifabutin rifabutin CAPSULE ORAL 20140407 NDA NDA050689 Greenstone LLC RIFABUTIN 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 59762-1515_c104c002-f250-4aa8-a550-2228ab31695e 59762-1515 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Greenstone LLC CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59762-1516_c104c002-f250-4aa8-a550-2228ab31695e 59762-1516 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Greenstone LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59762-1517_c104c002-f250-4aa8-a550-2228ab31695e 59762-1517 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Greenstone LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59762-1518_c104c002-f250-4aa8-a550-2228ab31695e 59762-1518 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Greenstone LLC CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59762-1520_459595a8-83c3-459d-b5e6-801c6ccd2d5b 59762-1520 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070323 20200331 NDA AUTHORIZED GENERIC NDA019787 Greenstone LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 59762-1530_459595a8-83c3-459d-b5e6-801c6ccd2d5b 59762-1530 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070323 20200331 NDA AUTHORIZED GENERIC NDA019787 Greenstone LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 59762-1540_459595a8-83c3-459d-b5e6-801c6ccd2d5b 59762-1540 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20070323 20200430 NDA AUTHORIZED GENERIC NDA019787 Greenstone LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 59762-1710_38c73850-9bb4-4f51-8e84-4efbb2e4c073 59762-1710 HUMAN PRESCRIPTION DRUG Eplerenone eplerenone TABLET, FILM COATED ORAL 20020927 NDA AUTHORIZED GENERIC NDA021437 Greenstone LLC EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 59762-1720_38c73850-9bb4-4f51-8e84-4efbb2e4c073 59762-1720 HUMAN PRESCRIPTION DRUG Eplerenone eplerenone TABLET, FILM COATED ORAL 20020927 NDA AUTHORIZED GENERIC NDA021437 Greenstone LLC EPLERENONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 59762-2001_fa8e2c8c-169f-4cfb-8a9d-26b3f7fd84ef 59762-2001 HUMAN PRESCRIPTION DRUG Ziprasidone ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA AUTHORIZED GENERIC NDA020825 Greenstone LLC ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 59762-2002_fa8e2c8c-169f-4cfb-8a9d-26b3f7fd84ef 59762-2002 HUMAN PRESCRIPTION DRUG Ziprasidone ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA AUTHORIZED GENERIC NDA020825 Greenstone LLC ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 59762-2003_fa8e2c8c-169f-4cfb-8a9d-26b3f7fd84ef 59762-2003 HUMAN PRESCRIPTION DRUG Ziprasidone ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA AUTHORIZED GENERIC NDA020825 Greenstone LLC ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 59762-2004_fa8e2c8c-169f-4cfb-8a9d-26b3f7fd84ef 59762-2004 HUMAN PRESCRIPTION DRUG Ziprasidone ziprasidone hydrochloride CAPSULE ORAL 20010205 NDA AUTHORIZED GENERIC NDA020825 Greenstone LLC ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 59762-2250_5fe2693e-5f05-42e2-bde7-bde969479f48 59762-2250 HUMAN PRESCRIPTION DRUG Ethosuximide Ethosuximide CAPSULE ORAL 20000922 NDA AUTHORIZED GENERIC NDA012380 Greenstone LLC ETHOSUXIMIDE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 59762-2310_7bd12dde-fb15-40a2-b4df-5923825ba109 59762-2310 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20140707 NDA NDA019668 Greenstone LLC DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59762-2320_7bd12dde-fb15-40a2-b4df-5923825ba109 59762-2320 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20140707 NDA NDA019668 Greenstone LLC DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59762-2321_00f81c1c-0be0-41bd-8be2-83718de95663 59762-2321 HUMAN PRESCRIPTION DRUG Eletriptan eletriptan hydrobromide TABLET, FILM COATED ORAL 20170724 NDA AUTHORIZED GENERIC NDA021016 Greenstone LLC ELETRIPTAN HYDROBROMIDE 20 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 59762-2322_00f81c1c-0be0-41bd-8be2-83718de95663 59762-2322 HUMAN PRESCRIPTION DRUG Eletriptan eletriptan hydrobromide TABLET, FILM COATED ORAL 20170724 NDA AUTHORIZED GENERIC NDA021016 Greenstone LLC ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 59762-2340_7bd12dde-fb15-40a2-b4df-5923825ba109 59762-2340 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20140707 NDA NDA019668 Greenstone LLC DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59762-2350_187ba7f6-d0f4-4a3e-a204-b3c7c62ced6f 59762-2350 HUMAN PRESCRIPTION DRUG Ethosuximide Ethosuximide SOLUTION ORAL 20020227 ANDA ANDA080258 Greenstone LLC ETHOSUXIMIDE 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 59762-2380_7bd12dde-fb15-40a2-b4df-5923825ba109 59762-2380 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20140707 NDA NDA019668 Greenstone LLC DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59762-2858_15b67a48-ebe1-41b3-b6ae-061e44906505 59762-2858 HUMAN PRESCRIPTION DRUG EXEMESTANE Exemestane TABLET, SUGAR COATED ORAL 20110401 NDA AUTHORIZED GENERIC NDA020753 Greenstone LLC EXEMESTANE 25 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 59762-3051_70368501-f9fe-4583-8b12-b655aafd8baa 59762-3051 HUMAN PRESCRIPTION DRUG azithromycin AZITHROMYCIN POWDER, FOR SUSPENSION ORAL 19990212 NDA NDA050693 Greenstone LLC AZITHROMYCIN DIHYDRATE 1 g/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 59762-3060_528f82d4-408c-4475-a675-a6c67f5cd24a 59762-3060 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 19960718 NDA AUTHORIZED GENERIC NDA050711 Greenstone LLC AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 59762-3070_528f82d4-408c-4475-a675-a6c67f5cd24a 59762-3070 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 20020524 NDA AUTHORIZED GENERIC NDA050784 Greenstone LLC AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 59762-3080_70368501-f9fe-4583-8b12-b655aafd8baa 59762-3080 HUMAN PRESCRIPTION DRUG azithromycin AZITHROMYCIN TABLET, FILM COATED ORAL 19960612 NDA NDA050730 Greenstone LLC AZITHROMYCIN DIHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 59762-3110_528f82d4-408c-4475-a675-a6c67f5cd24a 59762-3110 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19951019 NDA AUTHORIZED GENERIC NDA050710 Greenstone LLC AZITHROMYCIN DIHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 59762-3120_528f82d4-408c-4475-a675-a6c67f5cd24a 59762-3120 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19951019 NDA AUTHORIZED GENERIC NDA050710 Greenstone LLC AZITHROMYCIN DIHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 59762-3130_528f82d4-408c-4475-a675-a6c67f5cd24a 59762-3130 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19951019 NDA AUTHORIZED GENERIC NDA050710 Greenstone LLC AZITHROMYCIN DIHYDRATE 900 mg/22.5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 59762-3140_528f82d4-408c-4475-a675-a6c67f5cd24a 59762-3140 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19951019 NDA AUTHORIZED GENERIC NDA050710 Greenstone LLC AZITHROMYCIN DIHYDRATE 1200 mg/30mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 59762-3304_1c44c120-e986-49e4-8f65-25d945d04093 59762-3304 HUMAN PRESCRIPTION DRUG NITROGLYCERIN nitroglycerin TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20160826 NDA AUTHORIZED GENERIC NDA021134 Greenstone LLC NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 59762-3328_baf74db1-bb4c-4bf0-9121-b8bc47a2330f 59762-3328 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE ORAL 19700522 NDA AUTHORIZED GENERIC NDA050162 Greenstone LLC CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 59762-3690_7df89193-d248-4dba-b838-0eca9fa8171a 59762-3690 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline hyclate CAPSULE ORAL 20150501 NDA AUTHORIZED GENERIC NDA050007 Greenstone LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 59762-3717_ba3e7156-5f0b-47f9-912b-749a13a2588a 59762-3717 HUMAN PRESCRIPTION DRUG Triazolam triazolam TABLET ORAL 19821115 NDA AUTHORIZED GENERIC NDA017892 Greenstone LLC TRIAZOLAM .125 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 59762-3718_ba3e7156-5f0b-47f9-912b-749a13a2588a 59762-3718 HUMAN PRESCRIPTION DRUG Triazolam triazolam TABLET ORAL 19821115 NDA AUTHORIZED GENERIC NDA017892 Greenstone LLC TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 59762-3719_89a098f0-ce27-47d8-8ba6-039d652d322f 59762-3719 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Greenstone LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 59762-3720_89a098f0-ce27-47d8-8ba6-039d652d322f 59762-3720 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Greenstone LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 59762-3721_89a098f0-ce27-47d8-8ba6-039d652d322f 59762-3721 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Greenstone LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 59762-3722_89a098f0-ce27-47d8-8ba6-039d652d322f 59762-3722 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Greenstone LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 59762-3728_a0a6302a-8f37-4cfa-90a3-0012d17edb07 59762-3728 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate SOLUTION TOPICAL 19800620 NDA AUTHORIZED GENERIC NDA050537 Greenstone LLC CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 59762-3740_58f8b437-9c73-4b13-960c-56f92af387c7 59762-3740 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate TABLET ORAL 19590603 NDA AUTHORIZED GENERIC NDA011839 Greenstone LLC MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 59762-3741_58f8b437-9c73-4b13-960c-56f92af387c7 59762-3741 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate TABLET ORAL 19590603 NDA AUTHORIZED GENERIC NDA011839 Greenstone LLC MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 59762-3742_58f8b437-9c73-4b13-960c-56f92af387c7 59762-3742 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate TABLET ORAL 19590603 NDA AUTHORIZED GENERIC NDA011839 Greenstone LLC MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 59762-3743_a0a6302a-8f37-4cfa-90a3-0012d17edb07 59762-3743 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate GEL TOPICAL 19870107 NDA AUTHORIZED GENERIC NDA050615 Greenstone LLC CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 59762-3744_a0a6302a-8f37-4cfa-90a3-0012d17edb07 59762-3744 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate LOTION TOPICAL 19890531 NDA AUTHORIZED GENERIC NDA050600 Greenstone LLC CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 59762-4440_d27cd8eb-c953-4720-96e9-72ed32567613 59762-4440 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20111011 NDA AUTHORIZED GENERIC NDA011153 Greenstone LLC METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 59762-4537_4d5f16c3-d095-4fd0-bf98-0fc824d2f6d1 59762-4537 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA AUTHORIZED GENERIC NDA020246 Greenstone LLC MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 59762-4538_4d5f16c3-d095-4fd0-bf98-0fc824d2f6d1 59762-4538 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA AUTHORIZED GENERIC NDA020246 Greenstone LLC MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 59762-4900_350b8a77-215e-456a-b9e9-c45a3048463f 59762-4900 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 Greenstone LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 59762-4910_350b8a77-215e-456a-b9e9-c45a3048463f 59762-4910 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 Greenstone LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 59762-4921_1c44c120-e986-49e4-8f65-25d945d04093 59762-4921 HUMAN PRESCRIPTION DRUG NITROGLYCERIN nitroglycerin TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20160826 NDA AUTHORIZED GENERIC NDA021134 Greenstone LLC NITROGLYCERIN .3 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 59762-4940_350b8a77-215e-456a-b9e9-c45a3048463f 59762-4940 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride SOLUTION, CONCENTRATE ORAL 19920211 NDA AUTHORIZED GENERIC NDA020990 Greenstone LLC SERTRALINE HYDROCHLORIDE 20 mg/mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 59762-4960_350b8a77-215e-456a-b9e9-c45a3048463f 59762-4960 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 Greenstone LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 59762-5000_c2729435-59c9-4574-9397-5799dfb81e71 59762-5000 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20030701 NDA AUTHORIZED GENERIC NDA007073 Greenstone LLC SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 59762-5007_af802775-dfe7-47db-a387-2f234d4b7259 59762-5007 HUMAN PRESCRIPTION DRUG misoprostol MISOPROSTOL TABLET ORAL 20091227 NDA AUTHORIZED GENERIC NDA019268 Greenstone LLC MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 59762-5008_af802775-dfe7-47db-a387-2f234d4b7259 59762-5008 HUMAN PRESCRIPTION DRUG misoprostol MISOPROSTOL TABLET ORAL 20091227 NDA AUTHORIZED GENERIC NDA019268 Greenstone LLC MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 59762-5009_f09d0fdf-1b5f-4a4c-897e-ec8988e55f59 59762-5009 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate CREAM VAGINAL 19920811 NDA AUTHORIZED GENERIC NDA050680 Greenstone LLC CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 59762-5010_baf74db1-bb4c-4bf0-9121-b8bc47a2330f 59762-5010 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE ORAL 19700522 NDA AUTHORIZED GENERIC NDA050162 Greenstone LLC CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 59762-5011_b913a866-0a80-4862-9ec3-f603f905da71 59762-5011 HUMAN PRESCRIPTION DRUG spironolactone spironolactone TABLET, FILM COATED ORAL 19600121 20210331 NDA AUTHORIZED GENERIC NDA012151 Greenstone LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 59762-5012_b913a866-0a80-4862-9ec3-f603f905da71 59762-5012 HUMAN PRESCRIPTION DRUG spironolactone spironolactone TABLET, FILM COATED ORAL 19600121 20210131 NDA AUTHORIZED GENERIC NDA012151 Greenstone LLC SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 59762-5013_b913a866-0a80-4862-9ec3-f603f905da71 59762-5013 HUMAN PRESCRIPTION DRUG spironolactone spironolactone TABLET, FILM COATED ORAL 19600121 20181031 NDA AUTHORIZED GENERIC NDA012151 Greenstone LLC SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 59762-5014_a4d468eb-b6c6-405d-83ad-694a922a64ce 59762-5014 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide spironolactone and hydrochlorothiazide TABLET, FILM COATED ORAL 19780101 NDA AUTHORIZED GENERIC NDA012616 Greenstone LLC SPIRONOLACTONE; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 59762-5015_88fb49c0-6c03-49f0-9215-73e8a8f867c7 59762-5015 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 19900129 NDA AUTHORIZED GENERIC NDA019949 Greenstone LLC FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 59762-5016_88fb49c0-6c03-49f0-9215-73e8a8f867c7 59762-5016 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 19900129 NDA AUTHORIZED GENERIC NDA019949 Greenstone LLC FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 59762-5017_88fb49c0-6c03-49f0-9215-73e8a8f867c7 59762-5017 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 19900129 NDA AUTHORIZED GENERIC NDA019949 Greenstone LLC FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 59762-5018_88fb49c0-6c03-49f0-9215-73e8a8f867c7 59762-5018 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 19900129 NDA AUTHORIZED GENERIC NDA019949 Greenstone LLC FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 59762-5021_982b4358-b016-4351-9fda-38d8c42dcf72 59762-5021 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 20180531 NDA AUTHORIZED GENERIC NDA019885 Greenstone LLC QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 59762-5022_982b4358-b016-4351-9fda-38d8c42dcf72 59762-5022 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 20180331 NDA AUTHORIZED GENERIC NDA019885 Greenstone LLC QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 59762-5023_053c7c24-aab1-403f-a06f-02d505ccd555 59762-5023 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 19981009 NDA AUTHORIZED GENERIC NDA020882 Greenstone LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 59762-5024_053c7c24-aab1-403f-a06f-02d505ccd555 59762-5024 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 19981009 NDA AUTHORIZED GENERIC NDA020882 Greenstone LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 59762-5025_053c7c24-aab1-403f-a06f-02d505ccd555 59762-5025 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin SUSPENSION ORAL 20110329 NDA AUTHORIZED GENERIC NDA021129 Greenstone LLC GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 59762-5026_053c7c24-aab1-403f-a06f-02d505ccd555 59762-5026 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin CAPSULE ORAL 19931230 NDA AUTHORIZED GENERIC NDA020235 Greenstone LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 59762-5027_053c7c24-aab1-403f-a06f-02d505ccd555 59762-5027 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin CAPSULE ORAL 19931230 NDA AUTHORIZED GENERIC NDA020235 Greenstone LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 59762-5028_053c7c24-aab1-403f-a06f-02d505ccd555 59762-5028 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin CAPSULE ORAL 19931230 NDA AUTHORIZED GENERIC NDA020235 Greenstone LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 59762-5029_88fb49c0-6c03-49f0-9215-73e8a8f867c7 59762-5029 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole POWDER, FOR SUSPENSION ORAL 19931223 NDA AUTHORIZED GENERIC NDA020090 Greenstone LLC FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 59762-5030_88fb49c0-6c03-49f0-9215-73e8a8f867c7 59762-5030 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole POWDER, FOR SUSPENSION ORAL 19931223 NDA AUTHORIZED GENERIC NDA020090 Greenstone LLC FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 59762-5091_3d69a668-3124-4002-9822-84e52314c573 59762-5091 HUMAN PRESCRIPTION DRUG epirubicin hydrochloride epirubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19990915 NDA AUTHORIZED GENERIC NDA050778 Greenstone, LLC EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 59762-5093_3d69a668-3124-4002-9822-84e52314c573 59762-5093 HUMAN PRESCRIPTION DRUG epirubicin hydrochloride epirubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 19990915 NDA AUTHORIZED GENERIC NDA050778 Greenstone, LLC EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 59762-5210_6303490a-66fc-45df-b923-b441241ba2a2 59762-5210 HUMAN PRESCRIPTION DRUG Phenytoin Infatabs Phenytoin TABLET, CHEWABLE ORAL 20121227 ANDA ANDA084427 Greenstone LLC PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 59762-5310_1abe1312-91e1-4efe-b8ab-2f3d4efe038d 59762-5310 HUMAN PRESCRIPTION DRUG Prazosin prazosin hydrochloride CAPSULE ORAL 20170116 NDA AUTHORIZED GENERIC NDA017442 Greenstone LLC PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59762-5320_1abe1312-91e1-4efe-b8ab-2f3d4efe038d 59762-5320 HUMAN PRESCRIPTION DRUG Prazosin prazosin hydrochloride CAPSULE ORAL 20170116 NDA AUTHORIZED GENERIC NDA017442 Greenstone LLC PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59762-5350_1abe1312-91e1-4efe-b8ab-2f3d4efe038d 59762-5350 HUMAN PRESCRIPTION DRUG Prazosin prazosin hydrochloride CAPSULE ORAL 20170116 NDA AUTHORIZED GENERIC NDA017442 Greenstone LLC PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 59762-6002_f9779469-5838-4fc1-adeb-ccf069e46b80 59762-6002 HUMAN PRESCRIPTION DRUG oxaprozin oxaprozin TABLET, FILM COATED ORAL 20130327 NDA AUTHORIZED GENERIC NDA018841 Greenstone LLC OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 59762-6690_b59028db-b751-45a1-b5af-d72e2e3c5e31 59762-6690 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100331 NDA AUTHORIZED GENERIC NDA019684 Greenstone LLC NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 59762-6691_b59028db-b751-45a1-b5af-d72e2e3c5e31 59762-6691 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100331 NDA AUTHORIZED GENERIC NDA019684 Greenstone LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 59762-6692_b59028db-b751-45a1-b5af-d72e2e3c5e31 59762-6692 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100331 NDA AUTHORIZED GENERIC NDA019684 Greenstone LLC NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 59762-6710_4247377f-3478-43f7-a384-1845a450f910 59762-6710 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 59762-6711_4247377f-3478-43f7-a384-1845a450f910 59762-6711 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 59762-6712_4247377f-3478-43f7-a384-1845a450f910 59762-6712 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 59762-6720_4247377f-3478-43f7-a384-1845a450f910 59762-6720 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 10 mg/1; mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 59762-6721_4247377f-3478-43f7-a384-1845a450f910 59762-6721 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 59762-6722_4247377f-3478-43f7-a384-1845a450f910 59762-6722 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 59762-6723_4247377f-3478-43f7-a384-1845a450f910 59762-6723 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 59762-6730_4247377f-3478-43f7-a384-1845a450f910 59762-6730 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 59762-6731_4247377f-3478-43f7-a384-1845a450f910 59762-6731 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 59762-6732_4247377f-3478-43f7-a384-1845a450f910 59762-6732 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 59762-6733_4247377f-3478-43f7-a384-1845a450f910 59762-6733 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20140404 NDA AUTHORIZED GENERIC NDA021540 Greenstone LLC AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 59764-522_2eb8e2af-3d59-417f-b83d-8a0e8f19688a 59764-522 HUMAN OTC DRUG NovaClenz Instant Hand Sanitizer ALCOHOL SOAP TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333E Micronova ALCOHOL .62 mL/mL E 20171231 59767-004_5514b35a-081c-740f-e054-00144ff8d46c 59767-004 HUMAN PRESCRIPTION DRUG PERTZYE pancrelipase CAPSULE, DELAYED RELEASE ORAL 20161006 NDA NDA022175 Digestive Care, Inc. PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE 4000; 15125; 14375 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 59767-008_5514b35a-081c-740f-e054-00144ff8d46c 59767-008 HUMAN PRESCRIPTION DRUG PERTZYE pancrelipase CAPSULE, DELAYED RELEASE ORAL 20120517 NDA NDA022175 Digestive Care, Inc. PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE 8000; 30250; 28750 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 59767-016_5514b35a-081c-740f-e054-00144ff8d46c 59767-016 HUMAN PRESCRIPTION DRUG PERTZYE pancrelipase CAPSULE, DELAYED RELEASE ORAL 20120517 NDA NDA022175 Digestive Care, Inc. PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE 16000; 60500; 57500 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 59767-024_5514b35a-081c-740f-e054-00144ff8d46c 59767-024 HUMAN PRESCRIPTION DRUG PERTZYE pancrelipase CAPSULE, DELAYED RELEASE ORAL 20120517 NDA NDA022175 Digestive Care, Inc. PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE 24000; 90750; 86250 [USP'U]/1; [USP'U]/1; [USP'U]/1 N 20181231 59779-000_349db38d-ecdb-4cde-a609-c34bafb851a4 59779-000 HUMAN OTC DRUG CVS SPF 8 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20121211 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; OXYBENZONE 5; 2 g/100g; g/100g N 20181231 59779-001_dc9ac1cf-f0f7-496a-8ed0-2c3e78930599 59779-001 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20040507 ANDA ANDA076359 CVS Pharmacy IBUPROFEN 100 mg/1 N 20181231 59779-003_feb0cd19-219e-4f79-9d43-9ebbfbd180d5 59779-003 HUMAN OTC DRUG Poly Bacitracin Bacitracin Zinc, Polymyxin B Sulfate OINTMENT TOPICAL 20050103 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 59779-004_4faa45f8-0b82-41a7-9bc7-494bee362170 59779-004 HUMAN OTC DRUG Anticavity Fluoride Rinse Anticavity Rinse MOUTHWASH ORAL 20040408 OTC MONOGRAPH FINAL part355 CVS Pharmacy, Inc SODIUM FLUORIDE .02 kg/100L N 20181231 59779-005_62e5d8ce-3f92-4898-afe4-73c7cd9e947a 59779-005 HUMAN OTC DRUG CVS Triple-Thick Antibacterial Washcloths Benzalkonium Chloride CLOTH TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE .12 g/100mL N 20181231 59779-006_f7285833-3e35-4711-9ec6-8608d395d276 59779-006 HUMAN OTC DRUG CVS Pharmacy Childrens GLYCERIN SUPPOSITORIES LAXATIVE Glycerin LIQUID RECTAL 20020603 OTC MONOGRAPH NOT FINAL part334 CVS PHARMACY, INC. GLYCERIN 2.8 g/1 E 20171231 59779-009_643ddd8f-aada-4c4e-a690-0257d7c05929 59779-009 HUMAN OTC DRUG CVS Pharmacy GLYCERIN SUPPOSITORIES LAXATIVE Glycerin LIQUID RECTAL 20020603 OTC MONOGRAPH NOT FINAL part334 CVS PHARMACY, INC. GLYCERIN 5.4 g/1 E 20171231 59779-013_8743a95d-08a5-41d8-acd6-ce093795599a 59779-013 HUMAN OTC DRUG Allergy Relief d 12 Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120125 ANDA ANDA076050 CVS Pharmacy LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 59779-016_be94846c-698a-4c0f-8ef6-413d8da12a37 59779-016 HUMAN OTC DRUG PYRITHIONE ZINC PYRITHIONE ZINC LIQUID TOPICAL 20100716 OTC MONOGRAPH FINAL part358H CVS Pharmacy PYRITHIONE ZINC 29 mg/mL E 20171231 59779-017_728fce0a-459f-43a1-b0f9-1fea8917051b 59779-017 HUMAN OTC DRUG CVS Pharmacy Sport SPF 50 AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 8; 4 g/100g; g/100g; g/100g N 20181231 59779-019_801c5480-9853-4ab2-930d-c6f3d888ba2e 59779-019 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59779-020_fde79288-fa83-4347-8a12-0d6c4189ddba 59779-020 HUMAN OTC DRUG CVS Pharmacy Sunscreen SPF 45 OCTINOXATE, OCTOCRLYENE, ZINC OXIDE LOTION TOPICAL 20121217 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 7.5; 8; 6.8 g/100g; g/100g; g/100g N 20181231 59779-021_b49ee8e9-5675-4572-bdec-3409ae599ebe 59779-021 HUMAN OTC DRUG CVS Pharmacy Oil Free SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59779-022_e8f91864-8568-4bbe-b2b8-e8d2e5114acc 59779-022 HUMAN OTC DRUG heartburn relief Cimetidine TABLET ORAL 20000114 ANDA ANDA075285 CVS Pharmacy CIMETIDINE 200 mg/1 N 20181231 59779-023_b6d9fbc6-7121-4f20-b78b-10a3a9682788 59779-023 HUMAN OTC DRUG CVS Pharmacy Oil Free Faces SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121213 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 8; 5; 5; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59779-024_cbb61bf0-ab8a-41d7-a115-8f37403c74cb 59779-024 HUMAN OTC DRUG CVS Pharmacy SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59779-025_ece748cd-567e-4dd4-9b6b-5286f99eda99 59779-025 HUMAN OTC DRUG CVS Pharmacy SPF 15 OCTINOXATE, OXYBENZONE LOTION TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; OXYBENZONE 7.5; 4.5 g/100g; g/100g N 20181231 59779-026_49ded20b-c0c4-48d7-811b-d96e9df848d5 59779-026 HUMAN OTC DRUG CVS Clear Zinc SPF 50 OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; ZINC OXIDE 4; 5 g/100g; g/100g N 20181231 59779-028_be163877-e24b-49df-8431-209ce30643fb 59779-028 HUMAN OTC DRUG CVS Pharmacy Oil Free SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20130722 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59779-029_9b80879c-092b-4460-94e0-54359604b8e0 59779-029 HUMAN OTC DRUG nicotine stop smoking aid Nicotine Polacrilex GUM, CHEWING ORAL 20050707 ANDA ANDA076775 CVS Pharmacy NICOTINE 2 mg/1 N 20181231 59779-031_293faf1c-1e42-457c-9020-a7d871fe9b6a 59779-031 HUMAN OTC DRUG daytime cough nighttime cough dextromethorphan HBr, doxylamine succinate KIT 20120807 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-032_bbcbaa2d-2123-45b1-84fd-ccba83d5ed92 59779-032 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20101214 OTC MONOGRAPH FINAL part333D CVS Pharmacy, Inc SALICYLIC ACID 19.8 mg/g N 20181231 59779-033_a5f360eb-42f7-4f4b-81d9-6d56560bbf25 59779-033 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20100408 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ISOPROPYL ALCOHOL 500 mg/mL N 20191231 59779-034_127b816d-37ff-4b1e-9fef-b1cacb28dc63 59779-034 HUMAN OTC DRUG Cortisone Maximum Strength Hydrocortisone OINTMENT TOPICAL 20060425 20180331 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 g/100g N 20181231 59779-035_d585964d-4576-42d8-aa81-ca6fdd24a96b 59779-035 HUMAN OTC DRUG Minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20140429 ANDA ANDA091344 CVS Pharmacy MINOXIDIL 5 g/100g N 20181231 59779-036_0b9a0867-5d7a-4e04-a95f-0ea31bf05702 59779-036 HUMAN OTC DRUG CVS pharmacy Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20111020 OTC MONOGRAPH FINAL part350 CVS pharmacy ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g E 20171231 59779-037_415426b8-6bc4-4c2f-8be5-95010c462614 59779-037 HUMAN OTC DRUG CVS pharmacy Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20130801 OTC MONOGRAPH FINAL part350 CVS pharmacy ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g E 20171231 59779-038_8d2c018a-7e45-4097-8ba2-3d0360219678 59779-038 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 N 20181231 59779-039_108a4de8-892c-428d-b10e-03a114ed963c 59779-039 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 N 20181231 59779-041_e90fb7b3-994b-48a9-a115-a88af61ab3ef 59779-041 HUMAN OTC DRUG CVS Nighttime Cold/Flu Relief acetaminophen, dextromethorphan hydrobromide and doxylamine succinate LIQUID ORAL 20090709 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 59779-042_417e5fee-02e8-4618-962e-996d49439a3a 59779-042 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20100831 NDA NDA020065 CVS Pharmacy NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL N 20181231 59779-043_78c25e6d-e4b4-4417-b28f-513fa38a618c 59779-043 HUMAN OTC DRUG Motion Sickness II Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 CVS Pharmacy MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 59779-044_e336231b-36c0-475c-b636-6e66af50cf05 59779-044 HUMAN OTC DRUG CVS Pharmacy Pre-measured spoon Childrens ALLERGY MEDICATION Diphenhydramine Hydrochloride LIQUID ORAL 20110825 OTC MONOGRAPH FINAL part341 CVS PHARMACY, INC. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 59779-045_c9c9066e-79cd-4520-8cb0-ec617318888d 59779-045 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20110404 OTC MONOGRAPH FINAL part346 CVS Pharmacy WITCH HAZEL 979 mg/mL N 20181231 59779-046_aaf828a7-0297-4cd0-a2a0-205dac2f30e9 59779-046 HUMAN OTC DRUG Cold and Flu HBP Acetaminophen and Chlorpheniramine Maleate TABLET, COATED ORAL 20050531 20180604 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 325; 2 mg/1; mg/1 E 20171231 59779-047_2f22d1f6-e3b1-4201-824f-80806329f130 59779-047 HUMAN OTC DRUG Tussin CF Maximum Strength dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20140531 20180430 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 59779-048_e6a992c0-58b2-4ac5-9216-88fa5d817f75 59779-048 HUMAN OTC DRUG CVS Maximum Strength Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE GEL TOPICAL 20110810 OTC MONOGRAPH FINAL part336 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 20.5 mg/mL E 20171231 59779-050_19849d80-3df0-4a42-b4d3-8042db7f79be 59779-050 HUMAN OTC DRUG ibuprofen pm diphenhydramine citrate and ibuprofen TABLET, FILM COATED ORAL 20090217 ANDA ANDA079113 CVS Pharmacy DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 59779-051_d8f0f29b-38db-470e-8960-f8a59a532f70 59779-051 HUMAN OTC DRUG CVS Soothing Itch Relief MENTHOL LOTION TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL 1 mg/mL E 20171231 59779-052_c190935b-2f94-4c11-b531-f5726ea0904e 59779-052 HUMAN OTC DRUG CVS Fragrance Free Anti-Itch PRAMOXINE HYDROCHLORIDE LOTION TOPICAL 20100708 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy PRAMOXINE HYDROCHLORIDE 10 mg/mL E 20171231 59779-053_06fe2623-5c94-44f5-be30-57ec400e8a34 59779-053 HUMAN OTC DRUG CVS Extra Strength Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE and ZINC ACETATE OINTMENT TOPICAL 20100913 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 12 mg/g; mg/g E 20171231 59779-054_3d2cbee9-67ca-4d56-b082-53a3b7129af4 59779-054 HUMAN OTC DRUG CVS Vanishing Scent Muscle Rub MENTHOL GEL TOPICAL 20110314 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL 27.5 mg/g E 20171231 59779-055_04d696fc-a872-4988-bd20-2ae3d7ffd55b 59779-055 HUMAN OTC DRUG CVS Acne Spot Treatment SALICYLIC ACID GEL TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333D CVS Pharmacy SALICYLIC ACID 20 mg/mL E 20171231 59779-056_3279cb81-6ab0-4c53-866c-da71484c4eea 59779-056 HUMAN OTC DRUG CVS Therapeutic Menthol Pain Reliever MENTHOL GEL TOPICAL 20100710 OTC MONOGRAPH FINAL part348 CVS Pharmacy MENTHOL 20 mg/g E 20171231 59779-057_88ba2bcb-3df2-4411-8410-f03897589923 59779-057 HUMAN OTC DRUG CVS Chest Rub CAMPHOR, EUCALYPTUS OIL and MENTHOL OINTMENT TOPICAL 20110114 OTC MONOGRAPH FINAL part341 CVS Pharmacy CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 48; 12; 26 mg/g; mg/g; mg/g E 20171231 59779-058_9100c792-70b6-43fe-b8a4-a49a61de6d87 59779-058 HUMAN OTC DRUG CAMPHOR CAMPHOR LIQUID RESPIRATORY (INHALATION) 20090519 OTC MONOGRAPH NOT FINAL part348 CVS CAMPHOR (SYNTHETIC) 155 mg/mL E 20171231 59779-059_6f6f31ca-3031-4024-b5bc-2d202d82c8b5 59779-059 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ALCOHOL 616 mg/mL N 20181231 59779-062_0429b28f-c5f3-49e0-9b7d-f41f836f17b5 59779-062 HUMAN OTC DRUG CVS Pharmacy Clotrimazole 3 Clotrimazole CREAM VAGINAL 20000412 NDA NDA021143 CVS Pharmacy CLOTRIMAZOLE 2 g/100g N 20181231 59779-063_20261826-4c12-4497-bc95-3a2511f61f5c 59779-063 HUMAN OTC DRUG CVS Advanced Deep Set Wrinkle Therapy w/SPF15 ENSULIZOLE AND OCTINOXATE LOTION TOPICAL 20110719 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy ENSULIZOLE; OCTINOXATE 18; 75 mg/mL; mg/mL E 20171231 59779-064_5578f6cf-3b09-45eb-a98e-f5d8bc65e95e 59779-064 HUMAN OTC DRUG CVS Pharmacy Cough Relief Honey Lemon Flavor DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL LOZENGE ORAL 20140519 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL 5; 5 mg/1; mg/1 N 20181231 59779-066_70d371a1-418b-42e1-9e8d-4525fed47d9b 59779-066 HUMAN OTC DRUG Minoxidil for Women Minoxidil SOLUTION TOPICAL 20030101 ANDA ANDA074588 CVS Pharmacy MINOXIDIL 2 g/100mL N 20181231 59779-067_808a454c-4394-4225-8cb9-b5312afe5288 59779-067 HUMAN OTC DRUG ANTIBIOTIC ORIGINAL STRENGTH bacitracin, neomycin, polymyxin B OINTMENT TOPICAL 20050608 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 59779-068_8129e947-b93c-4c38-aa55-5a83d3798436 59779-068 HUMAN OTC DRUG PETROLATUM, LANOLIN PETROLATUM, LANOLIN OINTMENT TOPICAL 20090519 OTC MONOGRAPH FINAL part347 CVS PETROLATUM; LANOLIN .534; .155 g/g; g/g E 20171231 59779-069_d023d138-e60d-47e5-9988-1762b0a0aea4 59779-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 19920715 OTC MONOGRAPH FINAL part347 CVS Pharmacy PETROLATUM 1 g/g N 20191231 59779-070_83144c51-be60-4546-ba61-0e2c2228d068 59779-070 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ALCOHOL 700 mg/mL N 20181231 59779-071_028f4dda-2300-4da1-aeb8-35c72ab8883a 59779-071 HUMAN OTC DRUG Cooling Epsom Rub Menthol GRANULE, FOR SOLUTION TOPICAL 20150505 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc MENTHOL 11.7 mg/mL N 20181231 59779-072_20b8c7b2-c558-4856-840a-96602ad53e8a 59779-072 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 19950809 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 59779-073_0b258b2c-0f08-40df-8a4d-28d4f50db131 59779-073 HUMAN OTC DRUG CVS Clarifying Body Wash SALICYLIC ACID SOAP TOPICAL 20100710 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 20 mg/mL E 20171231 59779-074_0bfcfdb5-96a3-4b45-a570-d9372dad8ff7 59779-074 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 20060217 ANDA ANDA077349 CVS Pharmacy IBUPROFEN 200 mg/1 N 20181231 59779-075_74a45491-238b-48bf-8b14-569e1df61fef 59779-075 HUMAN OTC DRUG Cromolyn Sodium Cromolyn Sodium SPRAY, METERED NASAL 20010703 ANDA ANDA075702 CVS Pharmacy CROMOLYN SODIUM 5.2 mg/mL N 20181231 59779-076_d5f7a507-afb8-432b-8508-920d2de48415 59779-076 HUMAN OTC DRUG CVS Fast Clearing Medicated Pads SALICYLIC ACID SWAB TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333D CVS PHARMACY SALICYLIC ACID 21 mg/1 E 20171231 59779-077_3032b9b8-012e-4148-be34-a0e52d4809db 59779-077 HUMAN OTC DRUG CVS Daily Pore Clearing Pads SALICYLIC ACID SWAB TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part333D CVS PHARMACY SALICYLIC ACID 21 mg/1 E 20171231 59779-078_133e11e4-2ec4-4e9c-9d95-ac8d386d90d2 59779-078 HUMAN OTC DRUG SALICYLIC ACID SALICYLIC ACID LIQUID TOPICAL 20090519 OTC MONOGRAPH FINAL part333D CVS SALICYLIC ACID 5 mg/mL E 20171231 59779-079_878dd72f-d9ec-4942-96be-99fbd16070c9 59779-079 HUMAN OTC DRUG Clean Apple Pyrithione zinc SHAMPOO TOPICAL 20131206 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc PYRITHIONE ZINC 1 g/mL N 20181231 59779-080_67d2a6e8-9a44-4008-998a-0f0c4b67f414 59779-080 HUMAN OTC DRUG CVS Pharmacy Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 CVS Pharmacy TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 59779-081_4806c610-7f72-49cc-9419-7b6bd264d171 59779-081 HUMAN OTC DRUG TRICLOSAN TRICLOSAN LIQUID TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy TRICLOSAN 29 mg/mL E 20171231 59779-082_1d59fe5c-0280-435a-acb2-08bf20162755 59779-082 HUMAN OTC DRUG DIMETHICONE and ZINC OXIDE DIMETHICONE and ZINC OXIDE OINTMENT TOPICAL 20090601 OTC MONOGRAPH FINAL part347 CVS DIMETHICONE; ZINC OXIDE 10; 100 mg/g; mg/g E 20171231 59779-083_bcd1940d-100a-4572-be93-6cbb381b5105 59779-083 HUMAN OTC DRUG ZINC OXIDE ZINC OXIDE OINTMENT TOPICAL 20090519 OTC MONOGRAPH FINAL part347 CVS ZINC OXIDE 160 mg/g E 20171231 59779-084_3b795a50-bb86-4233-a22d-f6ec7f374b4c 59779-084 HUMAN OTC DRUG CVS PHARMACY ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131002 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL N 20181231 59779-084_443a0806-9a2c-40f8-8ac6-16a701db0173 59779-084 HUMAN OTC DRUG CVS PHARMACY ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131009 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL N 20181231 59779-084_61f073dc-e1bf-4e0b-bda7-a13060716595 59779-084 HUMAN OTC DRUG CVS PHARMACY ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131208 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL N 20181231 59779-084_db122365-4943-4c4e-8528-3d17dc00fb30 59779-084 HUMAN OTC DRUG CVS PHARMACY ALOE ETHYL ALCOHOL LIQUID TOPICAL 20131126 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL N 20181231 59779-085_e77febb7-201f-4252-85f3-c7d6908373fe 59779-085 HUMAN OTC DRUG POVIDONE IODINE POVIONE IODINE OINTMENT TOPICAL 20080730 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy POVIDONE-IODINE 1 g/10g E 20171231 59779-086_8dc1e977-90ce-43bd-a353-7802752b2886 59779-086 HUMAN OTC DRUG Advanced Healing Petrolatum OINTMENT TOPICAL 20090105 OTC MONOGRAPH FINAL part347 CVS Pharamacy, Inc PETROLATUM 340 mg/100g N 20181231 59779-087_a6ef7d2a-73f5-4f07-b29f-20bbceb3356a 59779-087 HUMAN OTC DRUG nicotine polacrilex Nicotine Polacrilex GUM, CHEWING ORAL 20050708 ANDA ANDA078326 CVS Pharmacy NICOTINE 4 mg/1 N 20181231 59779-088_4c3f3bbf-4bc8-4637-afdb-338d3817e878 59779-088 HUMAN OTC DRUG CAMPHOR (SYNTHETIC) and PHENOL CAMPHOR (SYNTHETIC) and PHENOL GEL TOPICAL 20090519 OTC MONOGRAPH FINAL part348 CVS CAMPHOR (SYNTHETIC); PHENOL 108; 47 mg/g; mg/g E 20171231 59779-091_38f8aae1-5f46-41a5-bce2-d3a6e4a62e64 59779-091 HUMAN OTC DRUG All Day Moisture Octinoxate, zinc oxide LOTION TOPICAL 20060228 OTC MONOGRAPH FINAL part352 CVS Pharmacy, Inc OCTINOXATE; ZINC OXIDE 60; 30 mg/mL; mg/mL N 20181231 59779-093_f5707614-e901-4611-8328-60d8447dc326 59779-093 HUMAN OTC DRUG Childrens Allergy Relief Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 CVS Pharmacy LORATADINE 5 mg/5mL N 20181231 59779-094_2e0eb9a2-4396-4c7a-826d-53277e26cd86 59779-094 HUMAN OTC DRUG nasal decongestant pe non drowsy Phenylephrine Hydrochloride TABLET ORAL 20050217 OTC MONOGRAPH FINAL part341 CVS Pharmacy PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 59779-095_8b40986e-5dcb-42e5-bcd1-c52b0fb92ffd 59779-095 HUMAN OTC DRUG TUSSIN CF NIGHTTIME COUGH and COLD acetaminophen, diphenhydramine HCl, phenylephrine HCl LIQUID ORAL 20140731 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 640; 25; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 59779-097_2994eeb4-76db-475e-8e44-b5f75a87e15c 59779-097 HUMAN OTC DRUG Miconazole Nitrate Athletes Foot Spray AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 3 g/150g N 20181231 59779-098_eea14fa9-9c3c-4b8a-b8d0-3bdd468dd7ff 59779-098 HUMAN OTC DRUG PETROLATUM and LANOLIN PETROLATUM and LANOLIN OINTMENT TOPICAL 20090519 OTC MONOGRAPH FINAL part347 CVS PETROLATUM; LANOLIN 534; 155 mg/g; mg/g E 20171231 59779-099_cbfabacb-882f-4911-b804-79006e056afe 59779-099 HUMAN OTC DRUG CVS Cortisone Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 g/100g N 20181231 59779-100_d94fdf70-1f2f-4004-a735-5b9a8800a810 59779-100 HUMAN OTC DRUG CVS Pharmacy Instant Hand Sanitizer With Moisturizers And Vitamin E ALCOHOL GEL TOPICAL 20091210 OTC MONOGRAPH NOT FINAL part333 CVS Pharmacy ALCOHOL 65 mL/100mL E 20171231 59779-101_d2a920ee-fbcd-4249-9176-4161b141d2b5 59779-101 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 19930121 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 N 20181231 59779-102_ed7b2cd3-a25d-444a-a9df-41b52e12b161 59779-102 HUMAN OTC DRUG Infants Relief Non-Staining Formula Dimethicone 410 LIQUID ORAL 20120203 OTC MONOGRAPH FINAL part332 CVS DIMETHICONE 410 20 mg/.3mL E 20171231 59779-104_e5951cf9-a1db-4737-ab45-edd998d0601c 59779-104 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 325 mg/1 N 20181231 59779-106_8f3d3891-d894-4808-86c8-b4a08bcf2ddc 59779-106 HUMAN OTC DRUG CVS Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 59779-107_54539040-666c-4f6c-bfd2-1201b55f495c 59779-107 HUMAN OTC DRUG CVS Gentle Laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy BISACODYL 10 mg/2000mg N 20181231 59779-107_7a9c1891-97db-46a4-b720-dbd26f031ed0 59779-107 HUMAN OTC DRUG CVS Gentle Laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy BISACODYL 10 mg/2000mg N 20181231 59779-108_e1d7a76a-df38-466e-a04d-b0932b7545af 59779-108 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20140731 ANDA ANDA078682 CVS Pharmacy IBUPROFEN 200 mg/1 N 20181231 59779-109_c64569c2-3c60-48e7-9cf3-118a6c7e7d39 59779-109 HUMAN OTC DRUG CVS Pharmacy Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy GLYCERIN 83 g/100g N 20181231 59779-109_ed48d215-946e-42db-b268-c160e7bcdbdc 59779-109 HUMAN OTC DRUG CVS Pharmacy Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy GLYCERIN 83 g/100g N 20181231 59779-109_f27ceb05-72ef-423e-8035-6e53a8aa64f9 59779-109 HUMAN OTC DRUG CVS Pharmacy Glycerin Laxative Glycerin Suppository SUPPOSITORY RECTAL 20140918 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy GLYCERIN 83 g/100g N 20181231 59779-111_cd85f9dd-6375-4aac-b0e8-03f5fe6447a7 59779-111 HUMAN OTC DRUG Oral Saline Laxative Ginger Lemon dibasic sodium phosphate, monobasic sodium phosphate LIQUID ORAL 20120831 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 2.7; 7.2 g/15mL; g/15mL E 20171231 59779-112_14448ef0-182e-4d18-b764-29f7368753b3 59779-112 HUMAN OTC DRUG Nasal Decongestant Non-Drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 19810825 OTC MONOGRAPH FINAL part341 CVS Pharmacy PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 59779-113_816bc873-4adf-4b6e-97da-30fcaaae6a28 59779-113 HUMAN OTC DRUG CVS PHARMACY JUICY PEAR BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160207 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-113_c3f352b2-e291-40b9-9d84-e2f868651208 59779-113 HUMAN OTC DRUG CVS PHARMACY JUICY PEAR BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-114_548e8cdf-28a5-4474-8439-b300e15c2e4f 59779-114 HUMAN OTC DRUG CVS PHARMACY FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-114_e7853a15-8990-459a-8d00-3f9b4a9177a7 59779-114 HUMAN OTC DRUG CVS PHARMACY FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-115_5d974d2d-4154-4802-8ace-ca466f730433 59779-115 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358F CVS Pharmacy SALICYLIC ACID 40 mg/91 N 20181231 59779-116_044f56b6-6187-40cc-9903-cc6bc61f6a0f 59779-116 HUMAN OTC DRUG Salicylic acid Medicated Callus Removers Extra Thick PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358F CVS Pharmacy SALICYLIC ACID 40 mg/41 N 20181231 59779-117_98e3d4a5-e160-4bda-b7b7-a71de030acb8 59779-117 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202319 CVS Pharmacy LANSOPRAZOLE 15 mg/1 N 20181231 59779-118_56479709-fd60-4c47-8fdc-53a18376b517 59779-118 HUMAN OTC DRUG CVS Therapeutic Menthol Gel Menthol GEL TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL 2 g/100g N 20181231 59779-119_56567212-9de5-4fce-80df-294ae75c7c93 59779-119 HUMAN OTC DRUG Salicylic acid One Step Wart Remover Strips PLASTER TOPICAL 20140104 OTC MONOGRAPH FINAL part358B CVS Pharmacy SALICYLIC ACID .4 g/1411 N 20181231 59779-120_84aadc71-65b1-40d4-83f7-0c5d5c936822 59779-120 HUMAN OTC DRUG C Lax Laxative Bisacodyl TABLET, COATED ORAL 20131230 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy BISACODYL 5 mg/1 N 20181231 59779-121_a7ed284f-1ce8-4769-9700-b7f5cf8c7b9e 59779-121 HUMAN OTC DRUG CVS Maximum Strength Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 59779-122_e5b3f159-921b-4633-a15e-64d26cf83c94 59779-122 HUMAN OTC DRUG CVS Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 59779-123_88f06fd2-73c3-443f-9e22-26c7c8aef2a8 59779-123 HUMAN OTC DRUG CVS Maximum Strength Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g N 20181231 59779-125_d1607809-1f27-44c5-b7ee-ad6929b5a4b7 59779-125 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20140515 OTC MONOGRAPH FINAL part332 CVS Pharmacy DIMETHICONE 180 mg/1 N 20181231 59779-126_3ad31ff0-6a20-467a-826f-3bf7585760c5 59779-126 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140124 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL N 20181231 59779-128_bd8c75e5-1723-4db4-8111-09e9b47dcc4c 59779-128 HUMAN OTC DRUG CVS Enamel Guard Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy SODIUM FLUORIDE; POTASSIUM NITRATE 1.5; 5 g/g; g/g N 20181231 59779-131_d5503749-81c6-479d-9f2f-b607b20021b7 59779-131 HUMAN OTC DRUG CVS Pharmacy Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20091204 ANDA ANDA079205 CVS Pharmacy IBUPROFEN 200 mg/1 N 20181231 59779-132_003de20a-3ba2-442a-a56f-c79b9f723b9e 59779-132 HUMAN OTC DRUG UNDECYLENIC ACID UNDECYLENIC ACID LIQUID TOPICAL 20080601 OTC MONOGRAPH FINAL part333C CVS Pharmacy UNDECYLENIC ACID 288 mg/mL E 20171231 59779-134_11430364-850d-40a7-87c4-867a750f26a0 59779-134 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20140430 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE CALCIUM 240 mg/1 N 20181231 59779-135_c6d91452-bccf-469e-9289-696b0fb4cedf 59779-135 HUMAN OTC DRUG CVS PSORIASIS MEDICATED Salicylic Acid LIQUID TOPICAL 20140901 OTC MONOGRAPH FINAL part358H CVS Pharmacy SALICYLIC ACID 3 g/100mL N 20181231 59779-136_630ff7c5-ab8b-6892-e053-2991aa0ad8fb 59779-136 HUMAN OTC DRUG Salicylic Acid Wart Remover Medicated Discs PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358B CVS Pharmacy SALICYLIC ACID 40 mg/181 N 20191231 59779-137_c3e60150-0e21-4a35-acae-d762fb923f84 59779-137 HUMAN OTC DRUG Aspirin Safety Coated Aspirin TABLET, COATED ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 325 mg/1 N 20181231 59779-138_03d088eb-1cb1-4a15-ada6-5df4b0f697e6 59779-138 HUMAN OTC DRUG Salicylic Acid Medicated Plantar Wart Remover PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358B CVS Pharmacy SALICYLIC ACID 40 mg/241 N 20181231 59779-139_33ee66e0-e01b-4c0f-a419-ee541f3ab4cd 59779-139 HUMAN OTC DRUG Salicylic Acid Corn and Callus Remover Kit LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part358F CVS Pharmacy SALICYLIC ACID .17 mg/151mL N 20181231 59779-141_4e078e66-df4e-4363-aae6-dc17f009f183 59779-141 HUMAN OTC DRUG acid controller original strength Famotidine TABLET ORAL 20091017 ANDA ANDA075400 CVS Pharmacy FAMOTIDINE 10 mg/1 N 20181231 59779-142_7525e273-51ea-4676-bcb8-1a32e66c3f42 59779-142 HUMAN OTC DRUG CVS Simple Care Protective Rash Dimethicone SPRAY TOPICAL 20140601 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 1 g/100mL N 20181231 59779-143_c9d89255-2b5f-4d45-9bb3-33101cb06d19 59779-143 HUMAN OTC DRUG Back and Body Extra Strength Aspirin, Caffeine TABLET, FILM COATED ORAL 20040412 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 N 20181231 59779-145_fae66f63-bfc3-4fe7-94b9-fdcb5713f06e 59779-145 HUMAN OTC DRUG Tussin DM Maximum Strength Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20140531 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL N 20181231 59779-147_c008cd4d-4046-4710-9f70-f1633f3e3a9d 59779-147 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100701 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 N 20181231 59779-148_42c804c8-dcab-4f72-8b93-be5728602a18 59779-148 HUMAN OTC DRUG PETROLATUM PETROLATUM OINTMENT TOPICAL 20090519 OTC MONOGRAPH FINAL part347 CVS PETROLATUM 600 mg/g E 20171231 59779-149_30c5f3f6-cff0-4129-a2d3-8ae0e8b03976 59779-149 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20120830 20180331 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 59779-150_7fbf0241-3719-4890-b7e1-fbf3ad297906 59779-150 HUMAN OTC DRUG CVS Moisturizing Lubricating Eye Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20130903 OTC MONOGRAPH FINAL part349 CVS Pharmacy CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/100mg; mg/100mg N 20181231 59779-151_5d978b52-4355-3d2e-e053-2991aa0ae0cb 59779-151 HUMAN OTC DRUG CVS Long Lasting Lubricant Eye Polyethylene Glycol 400 SOLUTION/ DROPS OPHTHALMIC 20130917 OTC MONOGRAPH FINAL part349 CVS Pharmacy, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 mg/mg; mg/mg N 20181231 59779-152_77a2498b-ef4b-49a6-a5bf-0fed8e9b3a0d 59779-152 HUMAN OTC DRUG CVS PHARMACY CLEAR SKIN DAILY MOISTURIZER SALICYLIC ACID LIQUID TOPICAL 20141130 OTC MONOGRAPH FINAL part333D CVS PHARMACY SALICYLIC ACID 5 mg/mL N 20181231 59779-153_78171f1f-dda2-43ca-96eb-c47dc36a62a1 59779-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 59779-155_8bd22188-ae51-46d0-8d4e-15d6c083bf15 59779-155 HUMAN OTC DRUG Total Home Antibacterial Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE .115 g/1 N 20181231 59779-156_89f8c068-dd77-41f1-831e-dd496aa17b6e 59779-156 HUMAN OTC DRUG CVS PHARMACY ADVANCED TANGERINE ETHYL ALCOHOL LIQUID TOPICAL 20150121 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL N 20181231 59779-157_b0aca242-5022-4600-9a9f-c5fe86c91e21 59779-157 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 325 mg/1 N 20181231 59779-158_271614fe-617b-4152-82d2-902c76e7db59 59779-158 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20140430 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 N 20181231 59779-160_98ffe67e-25a4-420b-94b9-0110ef0b1d97 59779-160 HUMAN OTC DRUG CVS Antibacterial Foaming Kitchen Triclosan SOAP TOPICAL 20101004 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .46 mL/100mL N 20181231 59779-161_b018abd6-fd29-488a-95f7-4dacf01fc494 59779-161 HUMAN OTC DRUG infants pain and fever Acetaminophen SUSPENSION ORAL 20111013 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL N 20181231 59779-162_b64abc78-afe9-49a1-80f6-5a58dd638269 59779-162 HUMAN OTC DRUG Senna Plus docusate sodium and sennosides TABLET ORAL 20100726 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 59779-163_cb2ce649-a2e2-48c9-ba66-273761580a9f 59779-163 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20080915 OTC MONOGRAPH FINAL part355 CVS Pharmacy, Inc SODIUM FLUORIDE .1 mg/mL N 20181231 59779-164_997aad2b-72c3-47cd-8c2a-1a5db235f0ba 59779-164 HUMAN OTC DRUG Ethyl Rubbing Alcohol Ethyl Alcohol LIQUID TOPICAL 20090518 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ALCOHOL 610 mg/mL N 20181231 59779-165_6654589c-800e-434e-9066-7be309d02d7f 59779-165 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Powder Miconazole Nitrate POWDER TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 1.42 g/71g N 20181231 59779-166_9c37fd5b-2dd4-4ad2-bb83-b022e8698b88 59779-166 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20020827 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL N 20181231 59779-167_355bbafd-f24b-4196-ad87-8a0de538a1d9 59779-167 HUMAN OTC DRUG Instant Miracle Illusion Smoother SPF 30 CVS Avobenzone 3.00% Homosalate 7.00% Oxybenzone 6.00% PASTE TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part352 CVS AVOBENZONE; HOMOSALATE; OXYBENZONE 3; 7; 6 g/100mL; g/100mL; g/100mL N 20181231 59779-168_e2208773-2d25-4a77-b5b0-753c61c6373d 59779-168 HUMAN OTC DRUG ANTIBACTERIAL FOAMING REFILL TRICLOSAN LIQUID TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .6 mL/100mL N 20181231 59779-169_8e3a3825-f95f-4259-a1c4-8c61123d219f 59779-169 HUMAN OTC DRUG ANTIBACTERIAL FOAMING HAND SP CLEAN AND MILD TRICLOSAN LIQUID TOPICAL 20110203 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .6 mL/100mL N 20181231 59779-170_5985bb73-632a-4281-9174-3be532357ed0 59779-170 HUMAN OTC DRUG nicotine polacrilex stop smoking aid Nicotine Polacrilex GUM, CHEWING ORAL 20050707 ANDA ANDA076789 CVS Pharmacy NICOTINE 4 mg/1 N 20181231 59779-171_1dbdb99a-344d-4613-9023-bea0a7043e10 59779-171 HUMAN OTC DRUG stool softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20131001 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE CALCIUM 240 mg/1 N 20181231 59779-172_44606113-4dee-4bd1-930e-e9aade3b65d5 59779-172 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium TABLET ORAL 20140430 ANDA ANDA079096 CVS Pharmacy NAPROXEN SODIUM 220 mg/1 N 20181231 59779-173_6ddce52c-0535-4108-a40d-242dffd580f1 59779-173 HUMAN OTC DRUG lice kit Piperonyl Butoxide, Pyrethrum Extract KIT 20070915 OTC MONOGRAPH FINAL part358G CVS Pharmacy N 20181231 59779-173_beaad131-f46c-462b-8c8c-aabd476d78dc 59779-173 HUMAN OTC DRUG lice kit piperonyl butoxide, pyrethrum extract KIT 20070915 OTC MONOGRAPH FINAL part358G CVS Pharmacy N 20181231 59779-174_ed417128-3343-4347-8986-14098e4ef432 59779-174 HUMAN OTC DRUG Calamine Plus Pramoxine HCl Calamine Plus Spray AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE .345; 24.16; 2.72 mg/116g; mg/116g; mg/116g N 20181231 59779-175_33420d42-4d2a-49e8-abf3-61c438e18455 59779-175 HUMAN OTC DRUG pain relief childrens Acetaminophen SUSPENSION ORAL 19931022 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL N 20181231 59779-176_405ccf4b-ec09-4bed-9d2e-801e952b013f 59779-176 HUMAN OTC DRUG Allergy Relief D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080410 ANDA ANDA077170 CVS Pharmacy CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 59779-177_23934d52-72d7-4f51-aa3c-55142631b245 59779-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110706 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .46 mL/100mL N 20181231 59779-178_b4eb834b-40dd-4471-815c-fb40076f175d 59779-178 HUMAN OTC DRUG Undecylenic Acid Liquid Anti-Fungal Liquid Maximum Strength LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy UNDECYLENIC ACID 7.5 g/30g N 20181231 59779-179_0153ca1e-5be7-4ddf-8993-44fb3c9bb65b 59779-179 HUMAN OTC DRUG CVS PHARMACY CLEAN ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .46 mg/100mL N 20181231 59779-179_80c68bd4-1d49-431b-a814-16098e9448b3 59779-179 HUMAN OTC DRUG CVS PHARMACY CLEAN ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120702 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .46 mg/100mL N 20181231 59779-182_92b757c0-e215-4a19-abb6-35694d867d11 59779-182 HUMAN OTC DRUG Senna laxative Natural vegetable laxative SENNOSIDES TABLET ORAL 20100729 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SENNOSIDES 8.6 mg/1 N 20181231 59779-183_2787f299-6475-4f38-8fee-c0f408991dc6 59779-183 HUMAN OTC DRUG Buffered Aspirin Regular Strength Aspirin TABLET, FILM COATED ORAL 19900330 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 325 mg/1 N 20181231 59779-184_5d465335-35ee-48fc-9f76-b8cc8ee108ac 59779-184 HUMAN OTC DRUG Dye-Free ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20141126 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/10mL N 20181231 59779-185_5ab2a7ad-b37c-473c-949c-f21341f3e6a3 59779-185 HUMAN OTC DRUG Salicylic Acid Wart Remover Gel Pen GEL TOPICAL 20141001 OTC MONOGRAPH FINAL part358B CVS Pharmacy SALICYLIC ACID .21 g/1.25g N 20181231 59779-186_34480b2a-2095-4581-874c-d8fd71c4f47e 59779-186 HUMAN OTC DRUG CVS Oral Anesthetic BENZOCAINE LIQUID ORAL 20100708 OTC MONOGRAPH FINAL part356 CVS Pharmacy BENZOCAINE 200 mg/mL N 20181231 59779-188_a9f154d3-621f-4f6a-bdba-c5bf10f42d22 59779-188 HUMAN OTC DRUG CVS PHARMACY PEAR WHITE TEA TRICLOSAN LIQUID TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .46 mL/100mL N 20181231 59779-188_c88db58a-5011-46e4-930f-40db16cc6d4c 59779-188 HUMAN OTC DRUG CVS PHARMACY PEAR WHITE TEA TRICLOSAN LIQUID TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .46 mL/100mL N 20181231 59779-189_c1f95d5d-50d4-47f2-b426-2028cd55ea16 59779-189 HUMAN OTC DRUG CVS PHARMACY MANDARIN CITRUS TRICLOSAN LIQUID TOPICAL 20120127 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .46 mL/100mL N 20181231 59779-190_594fb40f-c4ae-403e-b8ef-ec4b8564f9c7 59779-190 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20091001 ANDA ANDA090711 CVS Pharmacy NICOTINE 4 mg/1 N 20181231 59779-191_ed2837f3-6cff-43ea-a007-ab7a07ebfaf7 59779-191 HUMAN OTC DRUG KIDS PAIN RELIEF WITH ARNICA ARNICA MONTANA, HYPERICUM PERFORATUM CREAM TOPICAL 20121207 UNAPPROVED HOMEOPATHIC CVS PHARMACY ARNICA MONTANA; HYPERICUM PERFORATUM 1; 1 [hp_X]/50g; [hp_X]/50g N 20181231 59779-192_54fe52c7-6f62-43ca-a65c-86e8148c3f16 59779-192 HUMAN OTC DRUG KIDS FIRST AID WITH CALENDULA CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHYTOLACCA DECANDRA, CANTHARIS, SULPHUR CREAM TOPICAL 20121207 UNAPPROVED HOMEOPATHIC CVS PHARMACY CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; PHYTOLACCA AMERICANA ROOT; LYTTA VESICATORIA; SULFUR 1; 1; 3; 3; 3; 3 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g N 20181231 59779-193_def46ccd-27e5-4f76-a950-6f275071b633 59779-193 HUMAN OTC DRUG CVS Pharmacy Brilliant White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy SODIUM FLUORIDE .243 g/100g N 20181231 59779-194_62b90b76-b79b-4c87-9fd9-d53bbf22b190 59779-194 HUMAN OTC DRUG acid controller Famotidine TABLET ORAL 20060928 ANDA ANDA077351 CVS Pharmacy FAMOTIDINE 20 mg/1 N 20181231 59779-195_a4d78ad8-dd27-4129-acb3-13d7b8d1e6fd 59779-195 HUMAN OTC DRUG Dye-Free Adult ALLERGY Diphenhydramine Hydrochloride SOLUTION ORAL 20141126 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/20mL N 20181231 59779-196_8134ecf0-a785-4334-bec3-212bcdfb9443 59779-196 HUMAN OTC DRUG cough and sore throat childrens Acetaminophen, Dextromethorphan HBr SUSPENSION ORAL 20090715 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 160; 5 mg/5mL; mg/5mL N 20181231 59779-197_e5eb948f-71c1-417b-8e57-414e9223ea5b 59779-197 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120924 ANDA ANDA078682 CVS Pharmacy IBUPROFEN 200 mg/1 N 20181231 59779-198_40f05e18-14d0-40b8-95d5-2a3f775d54b1 59779-198 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 CVS Pharmacy DIMENHYDRINATE 50 mg/1 N 20181231 59779-199_27cb292a-cdb0-4048-a863-1bbd170eae66 59779-199 HUMAN OTC DRUG miconazole 1 yeast infection relief Miconazole nitrate KIT 20100608 ANDA ANDA079114 CVS Pharmacy N 20181231 59779-200_2a0a8b20-2894-4ee2-ab9a-95004e0796af 59779-200 HUMAN OTC DRUG CVS Pharmacy Instant Hand Sanitizer With Aloe And Vitamin E ALCOHOL GEL TOPICAL 20091210 OTC MONOGRAPH NOT FINAL part333 CVS Pharmacy ALCOHOL 65 mL/100mL E 20171231 59779-201_79489d1f-e8ac-4d72-96a4-5a4c44de5182 59779-201 HUMAN OTC DRUG nicotine Nicotine Polacrilex LOZENGE ORAL 20100512 ANDA ANDA090821 CVS Pharmacy NICOTINE 2 mg/1 N 20181231 59779-202_173288f5-86c5-4459-94c7-577336210dbd 59779-202 HUMAN OTC DRUG hair regrowth treatment for women minoxidil SOLUTION TOPICAL 19900415 ANDA ANDA075357 CVS Pharmacy MINOXIDIL 2 g/100mL N 20181231 59779-203_19ecb660-134e-4f89-8a3b-f64417c24673 59779-203 HUMAN OTC DRUG CVS pharmacy Clinical Strength Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20111024 OTC MONOGRAPH FINAL part350 CVS pharmacy ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g E 20171231 59779-204_73773dd0-d184-4b5d-8798-c5ba6c7d762e 59779-204 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 CVS Pharmacy PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 59779-205_3ded2ae2-c835-4e81-9c92-9b6849d4a8a9 59779-205 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE ORAL 20100716 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 N 20181231 59779-206_2df991cd-7a79-4194-bd6d-1203872748b5 59779-206 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070125 20190201 ANDA ANDA078325 CVS Pharmacy NICOTINE 2 mg/1 N 20181231 59779-208_98c887dd-8471-4af7-b83f-714a1c018287 59779-208 HUMAN OTC DRUG EARACHE KIDS RELIEF FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, PYROGENIUM, ARSENICUM ALBUM, BELLADONNA LIQUID ORAL 20121207 UNAPPROVED HOMEOPATHIC CVS PHARMACY FERRUM PHOSPHORICUM; RED PEPPER; RANCID BEEF; ARSENIC TRIOXIDE; ATROPA BELLADONNA 30; 30; 30; 30; 30 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 59779-209_d6cd514c-150e-40bb-a558-b569fd6cfadd 59779-209 HUMAN OTC DRUG TEETHING CHAMOMILLA, ARNICA MONTANA, BORAX, HYPERICUM PERFORATUM TABLET, CHEWABLE ORAL 20130501 UNAPPROVED HOMEOPATHIC CVS PHARMACY MATRICARIA RECUTITA; ARNICA MONTANA; SODIUM BORATE; HYPERICUM PERFORATUM 5; 5; 5; 5 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59779-210_181a4539-7f36-47b6-a14d-e512dbd98f31 59779-210 HUMAN OTC DRUG CVS Pharmacy Instant Hand Sanitizer With Aloe And Vitamin E ALCOHOL GEL TOPICAL 20100129 OTC MONOGRAPH NOT FINAL part333 CVS Pharmacy ALCOHOL 65 mL/100mL E 20171231 59779-211_df6f29c2-3133-462d-8b1c-91dc514fdd8c 59779-211 HUMAN OTC DRUG CVS PHARMACY ANTIBACTERIAL TRICLOSAN SOAP TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .15 mL/100mL N 20181231 59779-213_9fac7cb3-22f9-49de-9713-75ce14e56c87 59779-213 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20010619 OTC MONOGRAPH FINAL part355 CVS Pharmacy, Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 59779-216_53769624-5c8d-44ef-9671-3c4d9fea5a77 59779-216 HUMAN OTC DRUG Antibacterial Hand Triclosan SOAP TOPICAL 20100706 OTC MONOGRAPH NOT FINAL part333 CVS Pharmacy TRICLOSAN .15 mL/100mL N 20181231 59779-216_d9a07d4a-43a3-4e42-a548-2df3c1de4dc2 59779-216 HUMAN OTC DRUG Antibacterial Hand Triclosan SOAP TOPICAL 20100706 OTC MONOGRAPH NOT FINAL part333 CVS Pharmacy TRICLOSAN .15 mL/100mL N 20181231 59779-218_9c98bc89-6cfe-417f-8bab-b58636deae9d 59779-218 HUMAN OTC DRUG Chewable Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 20180304 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN 81 mg/1 E 20171231 59779-219_3a03fd1e-c0c3-4380-b660-01719a657899 59779-219 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20151122 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ALCOHOL 70 mL/100mL N 20181231 59779-220_0dbd9bc2-c27f-4ed8-99e6-b98798ed0a8f 59779-220 HUMAN OTC DRUG CVS Pharmacy Daytime Severe Cough and Cold Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20130401 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 59779-221_c73f9aba-85ae-4825-9fd4-572d4f28bc89 59779-221 HUMAN OTC DRUG CVS Pharmacy Nighttime Severe Cough and Cold honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20130325 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 59779-223_d9cab0d1-57f4-4e66-aab6-1b3b4aa8df1e 59779-223 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH ALOE ETHYL ALCOHOL GEL TOPICAL 20110318 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 62 mL/100mL N 20181231 59779-224_a79ca6dd-0028-44c9-bcef-b13cab3b64a0 59779-224 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH SHEA BUTTER ETHYL ALCOHOL GEL TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 62 mL/100mL N 20181231 59779-224_c99204a5-ceb2-4e2a-88b2-1de8cf3fe5a6 59779-224 HUMAN OTC DRUG Instant Hand Sanitizer With Shea Butter Ethyl Alcohol GEL TOPICAL 20100726 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy ALCOHOL 62 mL/100mL N 20181231 59779-224_f243e3e9-ccb3-411d-890f-813fb21320ee 59779-224 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH SHEA BUTTER ETHYL ALCOHOL GEL TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 62 mL/100mL N 20181231 59779-226_e059c171-e704-4593-baa3-2db92151291b 59779-226 HUMAN OTC DRUG Caffeine Caffeine TABLET ORAL 19921121 OTC MONOGRAPH FINAL part340 CVS Pharmacy CAFFEINE 200 mg/1 N 20181231 59779-227_c14ffa7d-0734-42fa-8aa9-4b32eaffac9e 59779-227 HUMAN OTC DRUG Aspirin Enteric Aspirin TABLET, COATED ORAL 19921214 20181102 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ASPIRIN 325 mg/1 E 20171231 59779-228_067495f0-9eed-4860-a506-dc21ea139bc7 59779-228 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20120919 OTC MONOGRAPH FINAL part338 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 59779-230_99112bc7-87aa-4f8a-8cfc-12374cd5b5cb 59779-230 HUMAN OTC DRUG Instant Burn Relief Aloe Extra CVS Lidocaine 0.50% SPRAY TOPICAL 20141111 OTC MONOGRAPH NOT FINAL part348 CVS LIDOCAINE .5 g/100g N 20181231 59779-231_6210d572-6283-4445-e053-2991aa0a360d 59779-231 HUMAN OTC DRUG CVS Athletes Foot Cream .5oz Tolnaftate CREAM TOPICAL 20141013 OTC MONOGRAPH FINAL part333C CVS Pharmacy, Inc. TOLNAFTATE 10 mg/g N 20191231 59779-232_4c178cb1-7545-46ce-bf22-c465f4e98e58 59779-232 HUMAN OTC DRUG CVS Phramacy Antibacterial Melon Triclosan SOAP TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .115 mL/100mL N 20181231 59779-233_4f043d8b-f8f9-4f1f-b97e-11e9e8f5374b 59779-233 HUMAN OTC DRUG Instant Cooling Itch Relief CVS 1% Hydrocortisone SPRAY TOPICAL 20141111 OTC MONOGRAPH NOT FINAL part348 CVS HYDROCORTISONE 1 g/100g N 20181231 59779-234_e47a279d-1bda-488b-b6f4-aecbdf78531c 59779-234 HUMAN OTC DRUG Instant Itch Relief CVS Diphenhydramine HCI 2.00% Zinc Acetate 0.10% SPRAY TOPICAL 20141113 OTC MONOGRAPH NOT FINAL part348 CVS DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 59779-235_b1490227-43f9-44c2-af28-53088f13af46 59779-235 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 59779-236_bd5f32e5-3ffc-4744-a118-0358a743577d 59779-236 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20191231 59779-237_637aef81-7d1c-41bc-b470-4a14b79b903c 59779-237 HUMAN OTC DRUG Arthritis Pain Relief Capsaicin 0.15 LIQUID TOPICAL 20141111 OTC MONOGRAPH NOT FINAL part348 CVS CAPSAICIN .15 g/100mL N 20181231 59779-238_e156754c-3747-4e8b-baa9-31620692b043 59779-238 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19950829 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy, Inc MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 59779-239_f30f7d01-3418-4ec1-940d-38da457f2f57 59779-239 HUMAN OTC DRUG Age Refine Day Cream CVS Octinoxate 7.50% Phenylbenzimidazole Sulfonic Acid 1.70% CREAM TOPICAL 20141126 OTC MONOGRAPH NOT FINAL part352 CVS OCTINOXATE; ENSULIZOLE 7.5; 1.7 g/100g; g/100g N 20181231 59779-240_6b81c091-805a-4992-b393-cf98124576b7 59779-240 HUMAN OTC DRUG Acne Treatment Benzoyl Peroxide 10% CREAM TOPICAL 20141031 OTC MONOGRAPH FINAL part333D CVS BENZOYL PEROXIDE 10 g/100g N 20181231 59779-241_8d84418e-a113-4313-8f96-f07e20626488 59779-241 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100716 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 125 mg/1 N 20181231 59779-243_44cf0d45-b136-4945-8b34-7e77f9cd71fc 59779-243 HUMAN OTC DRUG Acne Spot Treatment Benzoyl Peroxide 10% CREAM TOPICAL 20141031 OTC MONOGRAPH FINAL part333D CVS BENZOYL PEROXIDE 10 g/100g N 20181231 59779-244_199dff54-41ad-469a-8ae8-a990db8048d5 59779-244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 N 20181231 59779-245_fbfd9701-4aa1-49ad-b68f-453cad452c8e 59779-245 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20131030 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SENNOSIDES 25 mg/1 N 20181231 59779-247_7350bd03-d7d0-4044-add9-64744a420bd8 59779-247 HUMAN OTC DRUG CVS Medicated Pads WITCH HAZEL SWAB TOPICAL 20111113 OTC MONOGRAPH FINAL part346 CVS PHARMACY WITCH HAZEL 1 g/1 E 20171231 59779-248_4ce135fa-5afd-4639-bb93-90b7e58859fe 59779-248 HUMAN OTC DRUG CVS Extra Strength Itch Relief DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE SPRAY TOPICAL 20110810 OTC MONOGRAPH FINAL part336 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/mL; mg/mL E 20171231 59779-249_c98e80b9-8d4a-4504-a923-e3b030204f93 59779-249 HUMAN OTC DRUG Uncoated Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 325 mg/1 N 20181231 59779-250_664c5da7-0f64-4f93-b7cc-f81958dc40e0 59779-250 HUMAN OTC DRUG CVS Daily Acne Clearing Scrub SALICYLIC ACID SOAP TOPICAL 20111113 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 20 mg/mL E 20171231 59779-251_5c3315ea-87be-4066-83ce-943d17f36d6b 59779-251 HUMAN OTC DRUG ANTI-AGING HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110318 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 62 mL/100mL N 20181231 59779-252_13abf865-abaa-4e42-a301-39450946020e 59779-252 HUMAN OTC DRUG INSTANT FOAM HAND SANITIZER ALOE BENZALKONIUM CHLORIDE GEL TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 59779-253_1b6f78c3-2eee-409d-8068-4bf8ce4e9cd9 59779-253 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20110124 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 65 mL/100mL N 20181231 59779-253_6755eb01-4c0e-4ce2-880e-e82392e939d8 59779-253 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20110124 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 65 mL/100mL N 20181231 59779-254_87648b12-99a8-4ef6-bc29-d9beb014a85c 59779-254 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 65 mL/100mL N 20181231 59779-254_a53d8ffe-ad8f-4f34-bd9d-de10f6382d03 59779-254 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 65 mL/100mL N 20181231 59779-254_c8390466-507b-4338-a810-e572dfe05ea1 59779-254 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110823 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 65 mL/100mL N 20181231 59779-254_fd11cf87-d8fd-4af6-b054-afad61272725 59779-254 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 65 mL/100mL N 20181231 59779-255_c6e6e4ca-5c8f-494f-9499-e791571b82de 59779-255 HUMAN OTC DRUG BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 26; 25 mg/mL; mg/mL E 20171231 59779-256_c052e919-8825-4e92-b698-d3e745b61038 59779-256 HUMAN OTC DRUG CVS Antiseptic Wash BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 20 mg/mL; mg/mL E 20171231 59779-257_7334f45e-5f8f-4072-93e7-2f907db8d2d5 59779-257 HUMAN OTC DRUG CVS Earwax Removal Aid CARBAMIDE PEROXIDE LIQUID TOPICAL 20110425 OTC MONOGRAPH FINAL part344 CVS Pharmacy CARBAMIDE PEROXIDE 65 mg/mL E 20171231 59779-258_8f767897-e9c3-4078-9509-8ee5e0bc3ccf 59779-258 HUMAN OTC DRUG Antibacterial Hand Sanitizer Citrus Coconut Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL N 20181231 59779-258_c7156fa1-7a30-4a30-b832-93dd6c9cf6f9 59779-258 HUMAN OTC DRUG Antibacterial Hand Sanitizer Citrus Coconut Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL N 20181231 59779-259_0bdc89f7-4080-4329-a4dc-4d42458da5a6 59779-259 HUMAN OTC DRUG Antibacterial Hand Sanitizer Passion Flower Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL N 20181231 59779-259_c1ab44de-0487-4d69-9c95-5f040f003181 59779-259 HUMAN OTC DRUG Antibacterial Hand Sanitizer Passion Flower Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL N 20181231 59779-261_66244b08-bfc2-4e8c-b0c3-8c4dd9d6f262 59779-261 HUMAN OTC DRUG Antibacterial Hand Sanitizer Sunblossom Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL N 20181231 59779-261_b01940dc-a0a4-4ff2-8803-58bebb68cf3e 59779-261 HUMAN OTC DRUG Antibacterial Hand Sanitizer Sunblossom Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL N 20181231 59779-262_099b31b6-7b68-45f4-850a-69980998508e 59779-262 HUMAN OTC DRUG Antibacterial Hand Sanitizer Pamegranate Apple Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL N 20181231 59779-262_2fd52006-947d-4ab9-bb4b-58ee7c4412a6 59779-262 HUMAN OTC DRUG Antibacterial Hand Sanitizer Pamegranate Apple Alcohol GEL TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy Inc ALCOHOL 62 mL/100mL N 20181231 59779-263_378a3e3e-31e5-41ec-90a1-0ec9caaf1038 59779-263 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 19910615 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL N 20181231 59779-264_f01fe206-9289-48a2-935a-4051292a25d5 59779-264 HUMAN OTC DRUG CVS Revitalift Complete with SPF-15 ENSULIZOLE AND OCTINOXATE LOTION TOPICAL 20100719 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy ENSULIZOLE; OCTINOXATE 17; 75 mg/g; mg/g E 20171231 59779-265_a4d0d0be-1cb7-47a2-a6aa-75d93dea7545 59779-265 HUMAN OTC DRUG CVS HEMORRHOIDAL COOLING WITCH HAZEL, PHENYLEPHRINE HYDROCHLORIDE GEL TOPICAL 20101118 OTC MONOGRAPH FINAL part346 CVS Pharmacy WITCH HAZEL; PHENYLEPHRINE HYDROCHLORIDE 500; 2.5 mg/g; mg/g E 20171231 59779-266_dc15ce6c-3a42-4bd7-a178-8c332d7ae365 59779-266 HUMAN OTC DRUG Targeted Acne Spot Treatment CVS Benzoyl Peroxide 2.50% LOTION TOPICAL 20141126 OTC MONOGRAPH FINAL part333D CVS BENZOYL PEROXIDE 2.5 g/100g N 20181231 59779-267_43b58db2-ba99-416d-a288-6c959795ae8e 59779-267 HUMAN OTC DRUG CVS PHARMACY WITH VITAMIN E ETHYL ALCOHOL LIQUID TOPICAL 20131002 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL N 20181231 59779-269_e02a6643-2fcb-431d-af3b-0698ae1584a5 59779-269 HUMAN OTC DRUG Cold and Hot CVS Menthol 7.6% Mehyl Salicylate 29.0% SPRAY TOPICAL 20141113 OTC MONOGRAPH NOT FINAL part348 CVS MENTHOL; METHYL SALICYLATE 7.6; 29 g/100g; g/100g N 20181231 59779-270_e7a8d04d-6905-47b6-bcc4-bcdd6f28ae91 59779-270 HUMAN OTC DRUG Baby Pure Gentle SunStick SPF 60 CVS Titanium Dioxide 6.00% Zinc Oxide 4.70% STICK TOPICAL 20141117 OTC MONOGRAPH NOT FINAL part352 CVS TITANIUM DIOXIDE; ZINC OXIDE 6; 4.7 g/100g; g/100g N 20181231 59779-272_582e4be6-2c23-486f-a035-cd20e52b9f1d 59779-272 HUMAN OTC DRUG CVS WHITE TEA BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140422 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-273_2f6fa26f-81ea-490c-94d7-f5d08767db4f 59779-273 HUMAN OTC DRUG CVS WHITE TEA BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140422 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-274_dea5e5c2-07c6-4eb9-b067-e998d94687a2 59779-274 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 19970220 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 81 mg/1 N 20181231 59779-275_2ed25398-6f83-4276-bf10-9ba41d968629 59779-275 HUMAN OTC DRUG Severe Sinus Pain and Congestion Daytime acetaminophen, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 59779-276_2a3826ee-9df2-4902-a537-9152dada2da7 59779-276 HUMAN OTC DRUG CVS Pharmacy Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 59779-277_602e0dc8-afe1-06b0-e053-2991aa0afdc7 59779-277 HUMAN OTC DRUG CVS HYDROCORTISONE WITH ALOE HYDROCORTISONE CREAM TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 CVS PHARMACY HYDROCORTISONE .5 g/100g N 20181231 59779-278_f79efffe-3be0-472e-bd6a-9ee14a4014d6 59779-278 HUMAN OTC DRUG Broad Spectrum SPF 50 CVS Avobenzone 3% Homosalate 13% Octisalate 5% Octocrylene 7% Oxybenzone 4% LOTION TOPICAL 20141106 OTC MONOGRAPH NOT FINAL part352 CVS AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 59779-279_bdd8d723-3b46-4441-bddb-3c35574a1faf 59779-279 HUMAN OTC DRUG hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20140911 OTC MONOGRAPH FINAL part346 CVS Pharmacy COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 59779-280_a06c3716-6e49-4f22-a2b4-d7ff75596a37 59779-280 HUMAN OTC DRUG Miconazole Nitrate Athlete s Foot Spray AEROSOL, POWDER TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 2.6 g/130g N 20181231 59779-281_6e325f31-71db-4a83-96c2-e3707522f8dd 59779-281 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20020315 OTC MONOGRAPH FINAL part358H CVS Pharmacy PYRITHIONE ZINC 1 kg/100L N 20181231 59779-284_7fcc142e-92c6-4b88-af2c-55052c72b53c 59779-284 HUMAN OTC DRUG Antibacterial SUNBLOSSOM Triclosan SOAP TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .3 mL/100mL N 20181231 59779-285_8a4c07fd-3733-4ca2-b5c3-30af9999a5f4 59779-285 HUMAN OTC DRUG Antibacterial Passion Flower Triclosan SOAP TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .3 mL/100mL N 20181231 59779-286_2897159d-bd19-4180-a67e-8269ed4a5afe 59779-286 HUMAN OTC DRUG Antibacterial Pamegranate Apple Triclosan SOAP TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .3 mL/100mL N 20181231 59779-287_241f7db9-afcf-4105-ba0c-662097661752 59779-287 HUMAN OTC DRUG Antibacterial Citrus Coconut Triclosan SOAP TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .3 mL/100mL N 20181231 59779-288_871ecf4c-4c67-4b5f-b630-46bb2e3fd5bd 59779-288 HUMAN OTC DRUG chest congestion childrens Guaifenesin SOLUTION ORAL 20090311 OTC MONOGRAPH FINAL part341 CVS Pharmacy GUAIFENESIN 100 mg/5mL N 20181231 59779-289_52976dad-95f2-4918-8239-afa6547bc554 59779-289 HUMAN OTC DRUG Maximuim Strength Cetylpyridinium chloride RINSE ORAL 20130208 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc CETYLPYRIDINIUM CHLORIDE 1 mg/100mL N 20181231 59779-291_67d2ca2c-3a9f-4ffc-8984-bb2dfdff55f7 59779-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 CVS Pharmacy IBUPROFEN 200 mg/1 N 20181231 59779-292_576b0dcd-c301-4ec0-a9a4-32979a561903 59779-292 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 CVS Pharmacy IBUPROFEN 200 mg/1 N 20191231 59779-293_19303455-779f-41c6-9957-0e47144e77e4 59779-293 HUMAN OTC DRUG cold and cough nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20070728 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 59779-294_cdead933-0229-4e5f-8ee7-0ff286b2583b 59779-294 HUMAN OTC DRUG hair regrowth treatment for men Minoxidil AEROSOL, FOAM TOPICAL 20120302 ANDA ANDA091344 CVS Pharmacy MINOXIDIL 5 g/100g N 20181231 59779-295_8456ca99-0e6f-45a4-a946-c49704e4c4ca 59779-295 HUMAN OTC DRUG Itch Relief Clear Skin Protectant CVS Pramoxine HCl, Zinc Acetate SPRAY TOPICAL 20141031 OTC MONOGRAPH FINAL part347 CVS PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 1; .1 g/100g; g/100g N 20181231 59779-296_02f754b8-8dfc-4d78-92a1-ce9afaf2ecae 59779-296 HUMAN OTC DRUG Dry Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20090512 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 59779-298_2d7d57ee-4737-4b86-97ff-3dd67ec7e0a3 59779-298 HUMAN OTC DRUG Senna Laxative Sennosides TABLET ORAL 19950127 20181210 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SENNOSIDES 8.6 mg/1 N 20181231 59779-299_edff17f5-16c1-40bd-b675-ac5a41d98aca 59779-299 HUMAN OTC DRUG CVS Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20070501 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 59779-301_16c5d17c-4ff4-445a-9472-d236e3fdc648 59779-301 HUMAN OTC DRUG age renewal firming and hydrating moisturizer Octinoxate, Octisalate, Oxybenzone, Zinc Oxide CREAM TOPICAL 20091222 OTC MONOGRAPH FINAL part352 Woonsocket Prescription Center, Incorporated OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .075; .05; .04; .02 g/g; g/g; g/g; g/g N 20181231 59779-303_c374d43e-b980-427d-84c2-87c5eceb34f9 59779-303 HUMAN OTC DRUG Sodium Chloride Sodium Chloride OINTMENT OPHTHALMIC 20130221 OTC MONOGRAPH FINAL part349 CVS Pharmacy SODIUM CHLORIDE 50 mg/g N 20181231 59779-305_f0144e47-b5d2-4bec-9a28-fb4f28e65b48 59779-305 HUMAN OTC DRUG Clotrimazole 1% Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C CVS Pharmacy CLOTRIMAZOLE 10 mg/g N 20181231 59779-306_15176931-c3a2-490f-90c4-09465aaffc40 59779-306 HUMAN OTC DRUG purelax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091007 ANDA ANDA090685 CVS Pharmacy POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 59779-307_621254e2-d0eb-366d-e053-2991aa0a8e12 59779-307 HUMAN OTC DRUG CVS Pharmacy Anti-itch Hydrocortisone CREAM TOPICAL 20130430 OTC MONOGRAPH NOT FINAL part348 CVS HYDROCORTISONE 1 g/100g N 20191231 59779-308_4e2db2c7-b073-4a86-8436-5d21988467a7 59779-308 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140228 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL N 20181231 59779-309_c9a8f361-8656-4e99-9286-39bd13b3662c 59779-309 HUMAN OTC DRUG CVS Tropical Citrus Cough Menthol LOZENGE ORAL 20150114 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc. MENTHOL 3.1 mg/1 N 20181231 59779-311_6fa4a4eb-d072-4369-b9cc-cb4c736a8919 59779-311 HUMAN OTC DRUG Everyday Clean Pyrithione Zinc SHAMPOO TOPICAL 20060210 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc PYRITHIONE ZINC 1 g/100mL N 20181231 59779-313_2e5325b6-de8f-4eaa-b30a-d4f2e116b6cf 59779-313 HUMAN OTC DRUG ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20040507 ANDA ANDA075217 CVS Pharmacy IBUPROFEN 50 mg/1.25mL N 20181231 59779-315_33766ac3-4d6c-4d9f-994f-0b9b1f59cb58 59779-315 HUMAN OTC DRUG CVS Watermelon Cough Menthol LOZENGE ORAL 20150225 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc. MENTHOL 2.5 mg/1 N 20181231 59779-316_5d20049e-d3bd-4543-a14a-389257ff6d0a 59779-316 HUMAN OTC DRUG CVS Psoriasis Medicated SALICYLIC ACID SHAMPOO TOPICAL 20100716 OTC MONOGRAPH FINAL part358H CVS Pharmacy SALICYLIC ACID 30 mg/mL N 20181231 59779-317_9e42e976-631f-4836-840c-de9bd5bde4e3 59779-317 HUMAN OTC DRUG CVS DRY SKIN THERAPY WITH SPF 15 ENSULIZOLE, OCTISALATE AND OCTOCRYLENE LOTION TOPICAL 20100719 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy ENSULIZOLE; OCTISALATE; OCTOCRYLENE 10; 40; 10 mg/mL; mg/mL; mg/mL E 20171231 59779-318_a4afd246-11e9-4aef-9a22-ec9d38142e7a 59779-318 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE LIQUID TOPICAL 20100716 OTC MONOGRAPH FINAL part348 CVS Pharmacy HYDROCORTISONE 10 mg/mL N 20181231 59779-319_959cdf35-73f9-4be1-b426-0ff6fabba8da 59779-319 HUMAN OTC DRUG Cortisone Plus Aloe Maximum Strength Hydrocortisone CREAM TOPICAL 20120222 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 g/100g N 20181231 59779-320_2b5d0665-a2a0-4b02-ab92-995d3074a814 59779-320 HUMAN OTC DRUG DAILY MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 CVS PHARMACY INC DIMETHICONE 1.25 mL/100mL N 20181231 59779-321_ef9e122e-e550-495d-b5d7-1e83521840c7 59779-321 HUMAN OTC DRUG SKIN RELIEF MOISTURE LOT WITH SOOTHING OAT EXTRACTS DIMETHICONE LIQUID TOPICAL 20110117 OTC MONOGRAPH FINAL part347 CVS PHARMACY DIMETHICONE 1.3 mL/100mL N 20181231 59779-322_8eed5c4e-8e20-43f6-88b2-a04be7c50a6f 59779-322 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20090519 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 10 mg/g E 20171231 59779-323_109d9b2b-dca8-46d5-938a-53c9a46fe168 59779-323 HUMAN OTC DRUG CVS daily moisturizing with natural colloidal oatmeal Dimethicone LOTION TOPICAL 20160308 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 13 mg/mL N 20181231 59779-323_175de196-6021-4a01-901e-d3a6a8dc2182 59779-323 HUMAN OTC DRUG CVS daily moisturizing with natural colloidal oatmeal Dimethicone LOTION TOPICAL 20101013 OTC MONOGRAPH FINAL part347 CVS Pharmacy Inc DIMETHICONE 1.3 mL/100mL N 20181231 59779-323_b0626b8f-3921-4627-836a-b2ec0ed8c4e5 59779-323 HUMAN OTC DRUG CVS daily moisturizing with natural colloidal oatmeal Dimethicone LOTION TOPICAL 20101013 OTC MONOGRAPH FINAL part347 CVS Pharmacy Inc DIMETHICONE 1.3 mL/100mL N 20181231 59779-324_5ca340b7-8cb9-4a04-9a67-10fee4b3aa52 59779-324 HUMAN OTC DRUG DAILY MOISTURIZING DIMETHICONE LOTION TOPICAL 20111103 OTC MONOGRAPH FINAL part347 CVS PHARMACY DIMETHICONE 1.3 g/100g N 20181231 59779-325_0171491f-1a15-41ec-bb4d-85c128432e82 59779-325 HUMAN OTC DRUG CVS PHARMACY REFRESHING BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-325_2d9fa46d-ed0c-41bc-bdc2-e03fa0eb1c64 59779-325 HUMAN OTC DRUG CVS Pharmacy Refreshing Benzalkonium Chloride LIQUID TOPICAL 20170411 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-325_4d156275-7b40-4030-9e99-0709579f41b7 59779-325 HUMAN OTC DRUG CVS PHARMACY REFRESHING BENZALKONIUM CHLORIDE LIQUID TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-325_7296ebc0-d4f7-44ca-81f3-194e8a7d4338 59779-325 HUMAN OTC DRUG CVS PHARMACY REFRESHING BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-326_81bfb623-57f7-4a15-877f-5b2184a2e871 59779-326 HUMAN OTC DRUG ILLUMINATING DAILY MOISTURIZER SPF 30 HOMOSALATE LOTION TOPICAL 20100804 OTC MONOGRAPH FINAL part352 CVS PHARMACY INC HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE 12; 5; 3; 3; 1.7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 59779-327_8bed2b14-8d94-410b-bd74-c530f384e6cb 59779-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET, SUGAR COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy BISACODYL 5 mg/1 N 20191231 59779-330_401d38a8-0ada-4825-a819-2720780c5bcb 59779-330 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20130221 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .35 mg/mL N 20181231 59779-330_7e897ad1-a903-4e26-a9b4-f1f1e0155ee8 59779-330 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20131011 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .35 mg/mL N 20181231 59779-331_f6246c49-af1b-4eb0-b4f7-0b147fac8ecf 59779-331 HUMAN OTC DRUG MOISTURIZING HAND CITRUS COCONUT BENZALKONIUM CHLORIDE LOTION TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 59779-332_5f8a9181-1aee-39a2-e053-2a91aa0a1e1e 59779-332 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19920810 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 59779-334_bf5261c9-8ca6-4e90-bb92-9bebfaba4aad 59779-334 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 59779-335_e897fe60-ea80-4335-b6ae-8cf47f345ab6 59779-335 HUMAN OTC DRUG Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110816 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 59779-336_59d0f3f6-06f2-43f1-b220-4eedeb32e663 59779-336 HUMAN OTC DRUG Acetaminophen 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 CVS Pharmacy ACETAMINOPHEN 650 mg/1 N 20181231 59779-337_ee70a730-0ae9-492f-bc08-c48483adf861 59779-337 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100831 OTC MONOGRAPH FINAL part349 CVS Pharmacy WATER 99.05 mL/100mL N 20181231 59779-338_0e276afd-3498-414e-bb2b-9166c2358ceb 59779-338 HUMAN OTC DRUG Backache Relief Magnesium Salicylate TABLET, FILM COATED ORAL 19981107 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy MAGNESIUM SALICYLATE 580 mg/1 N 20181231 59779-339_3b5c7643-2484-4a25-bb1f-a3d1065068a8 59779-339 HUMAN OTC DRUG ANTIBACTERIAL MOISTURIZING HAND LOTION SUN BLOSSOM BENZALKONIUM CHLORIDE LOTION TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 59779-340_6d59e492-cf61-43aa-af10-4e0bfc2e38b4 59779-340 HUMAN OTC DRUG ARTHRITIS PAIN RELIEF Acetaminophen TABLET, EXTENDED RELEASE ORAL 20140214 ANDA ANDA078569 CVS PHARMACY ACETAMINOPHEN 650 mg/1 N 20191231 59779-340_bc7b84fa-0d30-4dea-975c-e94f5e3f6547 59779-340 HUMAN OTC DRUG ARTHRITIS PAIN RELIEF Acetaminophen TABLET, EXTENDED RELEASE ORAL 20140214 ANDA ANDA078569 CVS PHARMACY ACETAMINOPHEN 650 mg/1 N 20191231 59779-343_495e462d-4721-43fa-87b6-e7386ddd0338 59779-343 HUMAN OTC DRUG Advanced Acne Spot Treatment CVS Salicylic Acid 2.00% LOTION TOPICAL 20141222 OTC MONOGRAPH FINAL part333D CVS SALICYLIC ACID 2 g/100mL N 20181231 59779-344_a34caff6-9f2e-4670-813b-c5e696b9dff5 59779-344 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20060222 ANDA ANDA077007 CVS Pharmacy NICOTINE 2 mg/1 N 20181231 59779-345_6d36c707-d759-4bca-899c-89659fc433e5 59779-345 HUMAN OTC DRUG Caffeine Maximum Strength Caffeine TABLET, FILM COATED ORAL 19980414 OTC MONOGRAPH FINAL part340 CVS Pharmacy CAFFEINE 200 mg/1 N 20181231 59779-347_97752881-dbbb-42db-804f-8c0529683ac7 59779-347 HUMAN OTC DRUG INFANTS COUGH SYRUP DROSERA ROTUNDIFOLIA, BRYONIA ALBA, IPECACUANHA, SPONGIA TOSTA, CAUSTICUM, PHOSPHORUS, RUMEX CRISPUS SYRUP ORAL 20140221 UNAPPROVED HOMEOPATHIC CVS PHARMACY DROSERA ROTUNDIFOLIA; BRYONIA ALBA ROOT; IPECAC; SPONGIA OFFICINALIS SKELETON, ROASTED; CAUSTICUM; PHOSPHORUS; RUMEX CRISPUS ROOT 6; 6; 6; 6; 6; 12; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL N 20181231 59779-348_a15c36c3-9672-47ab-94f3-0dc11ee385af 59779-348 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20030104 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SENNOSIDES 25 mg/1 N 20181231 59779-349_67b3c625-2aa5-44eb-88a9-21d2eaf7af1e 59779-349 HUMAN OTC DRUG Intense CVS Intense Toothache Benzocaine PASTE, DENTIFRICE TOPICAL 20110120 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g N 20181231 59779-350_fcd17069-6b5c-46cc-aed9-0d735da363ba 59779-350 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 CVS Pharmacy ACETAMINOPHEN 650 mg/1 N 20181231 59779-351_48e16c6e-9c66-4dc8-b8ac-bca7f7a0630c 59779-351 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 19950921 20180723 OTC MONOGRAPH NOT FINAL part334 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DOCUSATE SODIUM 100 mg/1 E 20171231 59779-352_7a8a422a-2e69-468d-96c5-ba5b33cd1744 59779-352 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070915 ANDA ANDA078547 CVS Pharmacy NICOTINE 2 mg/1 N 20181231 59779-353_f9329d96-1c82-485c-a117-ce8086b9c3d8 59779-353 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141130 NDA NDA021920 CVS Pharmacy NAPROXEN SODIUM 220 mg/1 N 20181231 59779-354_995f33ab-158c-47f0-9c00-9bee7644c183 59779-354 HUMAN OTC DRUG ACID REDUCER Ranitidine TABLET ORAL 20120821 ANDA ANDA200536 CVS Pharmacy RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 59779-355_8e05c8f0-97bd-4ba7-9054-bad9cdaa0f1e 59779-355 HUMAN OTC DRUG ECZEMA CARE COLLOIDAL OATMEAL LOTION TOPICAL 20121203 OTC MONOGRAPH FINAL part347 CVS PHARMACY OATMEAL 10 mg/mL N 20181231 59779-355_f5fa36cb-a274-487e-8e19-6fa3119fd761 59779-355 HUMAN OTC DRUG Eczema Care Colloidal Oatmeal LOTION TOPICAL 20170828 OTC MONOGRAPH FINAL part347 CVS Pharmacy OATMEAL 10 mg/mL N 20181231 59779-356_f1bdb38f-d139-442c-ba58-6fb3bcd0a4b8 59779-356 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130919 ANDA ANDA201745 CVS Pharmacy, Inc RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 59779-357_36dca880-85ca-47c2-b87a-4e429f11c10f 59779-357 HUMAN OTC DRUG Antacid Regular Strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 19900515 OTC MONOGRAPH FINAL part331 CVS Pharmacy ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 59779-358_2c525133-9b72-4581-b9df-16041e845277 59779-358 HUMAN OTC DRUG CVS PHARMACY BABY MOISTURIZING DIMETHICONE LIQUID TOPICAL 20140623 OTC MONOGRAPH FINAL part347 CVS PHARMACY DIMETHICONE 12 mg/mL N 20181231 59779-359_54cb95b3-de29-4260-b07f-593c69ab082c 59779-359 HUMAN OTC DRUG Tussin DM Adult cough and chest congestion Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 19910924 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 59779-362_b7ca97ce-e024-4976-a0ab-c43415261481 59779-362 HUMAN OTC DRUG Aftersun Cooling CVS Lidocaine 0.5% GEL TOPICAL 20141111 OTC MONOGRAPH NOT FINAL part348 CVS LIDOCAINE .5 g/100mL N 20181231 59779-363_adb28401-7b9d-469a-8359-1aa43bc5a08c 59779-363 HUMAN OTC DRUG Cold and Cough childrens Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20060817 OTC MONOGRAPH FINAL part341 CVS Pharmacy BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 59779-364_2c787260-a9e4-4339-ad55-be4e860ec881 59779-364 HUMAN OTC DRUG Broad Spectrum SPF 15 CVS Avobenzone 2% Homosalate 10% Octisalate 5% Octocrylene 5% LOTION TOPICAL 20141106 OTC MONOGRAPH NOT FINAL part352 CVS AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 59779-365_942e558d-ed47-49c9-ae33-e46250b67803 59779-365 HUMAN OTC DRUG Naphazoline Hydrochloride and Pheniramine Maleate Naphazoline hydrochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20130125 ANDA ANDA202795 CVS Pharmacy NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL N 20181231 59779-366_75cd3af8-9730-4635-8d3e-fc1f70b6ac0b 59779-366 HUMAN OTC DRUG ALLERGY EYE DROPS Naphazoline hydrochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20130125 ANDA ANDA202795 CVS Pharmacy NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL N 20181231 59779-367_c4951a1a-26f4-4eae-99ee-fc2bb6cbe5bd 59779-367 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59779-370_1e7043dc-d5e0-41c7-843b-39ca81f272b4 59779-370 HUMAN OTC DRUG BABY COUGH SYRUP DROSERA ROTUNDIFOLIA, BRYONIA ALBA, IPECACUANHA, SPONGIA TOSTA, CAUSTICUM, PHOSPHORUS, RUMEX CRISPUS SYRUP ORAL 20140106 UNAPPROVED HOMEOPATHIC CVS PHARMACY DROSERA ROTUNDIFOLIA; BRYONIA ALBA ROOT; IPECAC; SPONGIA OFFICINALIS SKELETON, ROASTED; CAUSTICUM; PHOSPHORUS; RUMEX CRISPUS ROOT 6; 6; 6; 6; 6; 12; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL N 20181231 59779-371_0e7d7530-400a-4b48-ac51-ee4ad705d680 59779-371 HUMAN OTC DRUG BABY TINY COLD EUPHRASIA OFFICINALIS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, KALI IODATUM TABLET, ORALLY DISINTEGRATING ORAL 20140106 UNAPPROVED HOMEOPATHIC CVS PHARMACY EUPHRASIA STRICTA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 6; 6; 6; 6 [hp_X]/1251; [hp_X]/1251; [hp_X]/1251; [hp_X]/1251 N 20181231 59779-372_e0a49252-972b-4838-b115-73d67dfdb782 59779-372 HUMAN OTC DRUG BABY TEETHING CHAMOMILLA, CALCAREA PHOSPHORICA, COFFEA CRUDA, BELLADONNA TABLET, ORALLY DISINTEGRATING ORAL 20140106 UNAPPROVED HOMEOPATHIC CVS PHARMACY CHAMOMILE; CALCIUM PHOSPHATE; COFFEA ARABICA FRUIT; ATROPA BELLADONNA WHOLE 6; 6; 6; 12 [hp_X]/1351; [hp_X]/1351; [hp_X]/1351; [hp_X]/1351 N 20181231 59779-373_90e7fd56-0c1d-4dce-8b85-271e484cee3b 59779-373 HUMAN OTC DRUG Pain Relief PM Acetaminophen and Diphenhydramine Citrate TABLET, FILM COATED ORAL 20040607 20200217 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 N 20181231 59779-374_5e40ef9f-effb-4963-a82d-30ec060fde75 59779-374 HUMAN OTC DRUG migraine relief acetaminophen, aspirin, caffeine TABLET, FILM COATED ORAL 20020827 ANDA ANDA075794 CVS Pharmacy ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 59779-375_d7071df0-3daa-426d-8050-5bb1832d86af 59779-375 HUMAN OTC DRUG Anti-Diarrheal Loperamide TABLET ORAL 20050503 20181130 ANDA ANDA076497 CVS Pharmacy LOPERAMIDE HYDROCHLORIDE 2 mg/1 E 20171231 59779-376_5b207872-124b-4e35-a9d6-d4854d5fcf4e 59779-376 HUMAN OTC DRUG CVS VANISHING SCENT MUSCLE RUB MENTHOL GEL TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 CVS PHARMACY MENTHOL 2.5 g/100g N 20181231 59779-377_43c4571d-1a08-411f-b555-0e0e267d708c 59779-377 HUMAN OTC DRUG INFANT COLD EUPHRASIA OFFICINALIS, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, KALI IODATUM TABLET, ORALLY DISINTEGRATING ORAL 20140207 UNAPPROVED HOMEOPATHIC CVS PHARMACY EUPHRASIA STRICTA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 6; 6; 6; 6 [hp_X]/1251; [hp_X]/1251; [hp_X]/1251; [hp_X]/1251 N 20181231 59779-378_24e9847f-c8a8-4d12-b823-ba6f38ce97c8 59779-378 HUMAN OTC DRUG ANTI-WRINKLE AND FIRMING BROAD SPECTRUM SPF18 SUNSCREEN Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g N 20181231 59779-381_62d9aae4-aa48-9ae7-e053-2991aa0a9a1e 59779-381 HUMAN OTC DRUG CVS CAPSAICIN CAPSAICIN CREAM TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 CVS PHARMACY CAPSAICIN .1 g/100g N 20191231 59779-382_c0a3e672-4b3c-41e5-bc62-1441407f6118 59779-382 HUMAN OTC DRUG Sodium Chloride Sodium Chloride SOLUTION/ DROPS OPHTHALMIC 20130614 OTC MONOGRAPH FINAL part349 CVS Pharmacy SODIUM CHLORIDE 50 mg/mL N 20181231 59779-383_28c861a6-129c-4ca0-9843-ec77f6e17fac 59779-383 HUMAN OTC DRUG Sun Broad Spectrum SPF 30 CVS Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0% Octocrylene 10.0% LOTION TOPICAL 20141106 OTC MONOGRAPH NOT FINAL part352 CVS AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 59779-384_6a4485e7-1cf9-4ab5-b8c6-b1d61baf3b8c 59779-384 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120828 ANDA ANDA091135 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 59779-385_d83cf249-f82a-440a-9e21-61672c6acc5b 59779-385 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20140710 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/10mL; mg/10mL N 20181231 59779-386_e77eb5f5-18c1-46e0-9f3b-a2f21967ad6a 59779-386 HUMAN OTC DRUG Extra Strength Medicated Body Dimethicone LOTION TOPICAL 19921001 OTC MONOGRAPH FINAL part347 CVS Pharmacy, Inc DIMETHICONE; MENTHOL 5; .5 kg/100kg; kg/100kg N 20181231 59779-387_3b911a80-6a4c-44d1-9a8a-b0db2fd5975b 59779-387 HUMAN OTC DRUG Nasal Mist CVS Oxymetazoline Hydrochloride 0.05% LIQUID TOPICAL 20151001 OTC MONOGRAPH FINAL part341 CVS OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 59779-388_86ebc974-97bd-4534-bf64-a4db77367d7d 59779-388 HUMAN OTC DRUG nasal mist Oxymetazoline HCl SPRAY NASAL 20020904 OTC MONOGRAPH FINAL part341 CVS Pharmacy OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 59779-389_9aa20972-e0a5-4a29-a74e-ea90253ba7d6 59779-389 HUMAN OTC DRUG Genuine Aspirin Aspirin TABLET, FILM COATED ORAL 20010517 20190708 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 325 mg/1 E 20171231 59779-390_ed1d1fab-78a2-4d38-871e-366eff2cc714 59779-390 HUMAN OTC DRUG nose Phenylephrine hydrochloride SOLUTION/ DROPS NASAL 19910918 OTC MONOGRAPH FINAL part341 CVS Pharmacy PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 59779-392_361e0b73-89e0-40fa-a635-2343a4661a7c 59779-392 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 CVS Pharmacy IBUPROFEN 200 mg/1 N 20181231 59779-393_d460cf99-29ee-4365-96ea-3a4dbb25757c 59779-393 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 CVS Pharmacy IBUPROFEN 200 mg/1 N 20181231 59779-395_85b96afc-d011-4ade-b5d9-686aeda950ec 59779-395 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate Magnesium sulfate GRANULE ORAL; TOPICAL 20141231 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy MAGNESIUM SULFATE, UNSPECIFIED 1 g/g N 20181231 59779-396_fa5a387b-cc9f-4285-a9aa-3423ac2e7951 59779-396 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 19920807 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 59779-397_c15fda26-5c0d-4d32-91e1-32c7d7641263 59779-397 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 19980623 ANDA ANDA090711 CVS Pharmacy NICOTINE 2 mg/1 N 20181231 59779-398_d7142db6-14d7-43ab-b0dd-64459a2be200 59779-398 HUMAN OTC DRUG DIBUCAINE DIBUCAINE CREAM TOPICAL 20100716 OTC MONOGRAPH FINAL part346 CVS Pharmacy DIBUCAINE 10 mg/g E 20171231 59779-399_de6ea099-3261-4190-9166-b98319cbbdc3 59779-399 HUMAN OTC DRUG MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM TOPICAL 20100716 OTC MONOGRAPH FINAL part346 CVS Pharmacy MINERAL OIL; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE 466; 10; 125 mg/g; mg/g; mg/g E 20171231 59779-401_01e14dd4-f3d2-4aee-89d5-c1df553f1ffd 59779-401 HUMAN OTC DRUG COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20110701 OTC MONOGRAPH FINAL part346 CVS COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE .855; .0025 g/g; g/g E 20171231 59779-403_781a477f-015c-47a0-9706-162cd1b60e82 59779-403 HUMAN OTC DRUG CVS Hemorrhoidal PRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE AND PETROLATUM CREAM TOPICAL 20101215 OTC MONOGRAPH FINAL part346 CVS Pharmacy PRAMOXINE HYDROCHLORIDE; GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 10; 144; 150; 2.5 mg/g; mg/g; mg/g; mg/g E 20171231 59779-404_329e468e-1f38-46fa-9c82-ddac7cb5a353 59779-404 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET, CHEWABLE ORAL 20020529 OTC MONOGRAPH FINAL part336 CVS Pharmacy MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 59779-406_2a3fa9bd-1ca9-4212-992e-c793a6c8cfe0 59779-406 HUMAN OTC DRUG CVS Cold Sore Treatment Benzalkonium Chloride CREAM TOPICAL 20110517 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE 1.3 mg/g N 20181231 59779-407_38ce37eb-3da7-4f8e-a9c1-99eb7be8fd14 59779-407 HUMAN OTC DRUG nausea relief Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 19960530 UNAPPROVED DRUG OTHER CVS Pharmacy DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 59779-408_2897a4f9-70fc-4be6-8f3f-c368b8bb0997 59779-408 HUMAN OTC DRUG CVS SODIUM BICARBONATE, SODIUM CHLORIDE POWDER NASAL 20130601 UNAPPROVED DRUG OTHER CVS Pharmacy SODIUM BICARBONATE; SODIUM CHLORIDE 22.8; 77.8 mg/100mg; mg/100mg N 20181231 59779-408_facb509e-3b9c-4634-bf77-5af699b80fcd 59779-408 HUMAN OTC DRUG Refill Saline Packets SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION NASAL 20130401 UNAPPROVED DRUG OTHER CVS Pharmacy SODIUM BICARBONATE; SODIUM CHLORIDE 2300; 700 mg/1; mg/1 N 20181231 59779-409_e64ad72a-ce8c-46e3-8fba-9e8a409f6779 59779-409 HUMAN OTC DRUG Sleep Aid Nighttime Diphenhydramine HCl TABLET ORAL 20130815 OTC MONOGRAPH FINAL part338 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59779-410_8855d505-cae6-43f2-8992-80fde5a6483e 59779-410 HUMAN OTC DRUG CVS Pharmacy Cold and Sore Throat Lemon Flavor Acetaminophen, Pheniramine Maleate, Phenylephrine HCl GRANULE, FOR SOLUTION ORAL 20130401 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 20; 10 mg/1; mg/1; mg/1 N 20181231 59779-411_0ff16c33-45b8-4e93-8007-94919e4eeb74 59779-411 HUMAN OTC DRUG Cough and Cold Chlorpheniramine maleate and Dextromethorphan HBr TABLET, SUGAR COATED ORAL 20030503 OTC MONOGRAPH FINAL part341 CVS Pharmacy CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 59779-412_9d3c54ff-f84e-42fe-9956-1b4998cc28ea 59779-412 HUMAN OTC DRUG Tussin CF Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 59779-413_885ee5e1-acc1-4b3d-9628-4d1d82c1ca33 59779-413 HUMAN OTC DRUG ibuprofen pm Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20100302 ANDA ANDA079113 CVS Pharmacy DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 59779-414_3cc4dda1-637f-458d-a2e6-2334a452f948 59779-414 HUMAN OTC DRUG Adult Low Strength Aspirin Aspirin TABLET, COATED ORAL 20040114 20180310 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 81 mg/1 N 20181231 59779-415_6645108a-3657-46eb-9c59-1d2ef8d13cc7 59779-415 HUMAN OTC DRUG Indoor/Outdoor ALLERGY RELIEF Softgels Cetirizine Hydrochloride CAPSULE ORAL 20130301 NDA NDA022429 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 59779-417_c7988a8e-9ac0-4d0c-887e-fcbff909afee 59779-417 HUMAN OTC DRUG Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130815 ANDA ANDA076518 CVS Pharmacy NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 59779-418_01aed330-d7ba-aee5-01a7-1bf481ee8027 59779-418 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160229 ANDA ANDA208150 CVS Pharmacy FLUTICASONE PROPIONATE 50 ug/1 N 20181231 59779-419_4f94151d-7cdb-4d41-8043-a4bc8b28b825 59779-419 HUMAN OTC DRUG chest congestion childrens plus cough Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 20090311 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 59779-421_1347ce59-5b40-4176-b104-03730d063342 59779-421 HUMAN OTC DRUG FRUITOPIA PYRITHIONE ZINC LIQUID TOPICAL 20120217 OTC MONOGRAPH FINAL part358H CVS PHARMACY PYRITHIONE ZINC 1 mL/100mL N 20181231 59779-422_af0fba1d-8dc3-4f1e-89e3-db97c30d25d1 59779-422 HUMAN OTC DRUG BLADE HOWL ANTI-DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20101103 OTC MONOGRAPH FINAL part358H CVS PHARMACY INC PYRITHIONE ZINC 1 mL/100mL N 20181231 59779-423_fe6fe714-adda-40f3-9516-80597b85305b 59779-423 HUMAN OTC DRUG Allantoin Advanced Derma Spray AEROSOL, SPRAY TOPICAL 20150415 OTC MONOGRAPH FINAL part347 CVS Pharmacy ALLANTOIN .425 g/85g N 20181231 59779-424_9ba5ebc5-aeaa-46fd-8e4b-dd0bef444a0b 59779-424 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20100512 ANDA ANDA090821 CVS Pharmacy NICOTINE 4 mg/1 N 20181231 59779-425_e0a34e24-ac55-43c7-bd57-a69212e721a1 59779-425 HUMAN OTC DRUG Allergy relief Fexofenadine HCl TABLET, FILM COATED ORAL 20110831 ANDA ANDA076447 CVS Pharmacy FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 59779-426_602ebc5d-3c81-5e9f-e053-2a91aa0a27e2 59779-426 HUMAN OTC DRUG CVS Extra Strength Cold and Hot Medicated Patch Menthol PATCH TOPICAL 20140407 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. MENTHOL 750 mg/1 N 20181231 59779-427_d36c6041-cdb2-491f-b74b-c28ad692ec0b 59779-427 HUMAN OTC DRUG Oil Free Acne Cleansing Towelette Salicylic acid CLOTH TOPICAL 20130722 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 20.5 mg/mL N 20181231 59779-428_53863b72-f93a-4076-816a-f0b411b0ca88 59779-428 HUMAN OTC DRUG CVS PHARMACY DANDRUFF PYRITHIONE ZINC LIQUID TOPICAL 20131205 OTC MONOGRAPH FINAL part358H CVS PHARMACY PYRITHIONE ZINC 10 mg/mL N 20181231 59779-429_3a6bc22f-ecb8-43c0-b706-ad971daaed41 59779-429 HUMAN OTC DRUG Infants Pain and Fever acetaminophen suspension SUSPENSION ORAL 20140117 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL N 20181231 59779-430_ba5cb472-6757-43b8-88e0-861a3b8207dc 59779-430 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011011 ANDA ANDA074567 CVS Pharmacy IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 59779-431_aece81d6-69f2-4e39-ae39-85e27ab19b43 59779-431 HUMAN OTC DRUG sleep aid Diphenhydramine Hydrochloride TABLET ORAL 20001003 OTC MONOGRAPH FINAL part338 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59779-432_aa9ec20a-3e16-453b-b735-8fd3d462c151 59779-432 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 19870715 OTC MONOGRAPH FINAL part341 CVS Pharmacy PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 59779-433_51daa253-c16a-4770-963a-2042ae72cc22 59779-433 HUMAN OTC DRUG tussin Dextromethorphan Hydrobromide SOLUTION ORAL 19920513 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL N 20181231 59779-434_93e36475-32ae-4730-9a51-cbfccfbb0614 59779-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 59779-435_5f9b83dd-8bdf-39ca-e053-2a91aa0aad5a 59779-435 HUMAN OTC DRUG Nasal Mist CVS Oxymetazoline Hydrochloride 0.05% LIQUID TOPICAL 20151001 OTC MONOGRAPH FINAL part341 CVS OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 59779-436_acca9764-5c12-4bf5-a1c8-6d31d8121361 59779-436 HUMAN OTC DRUG Healing CVS Allantoin - 0.5% GEL TOPICAL 20151130 OTC MONOGRAPH FINAL part347 CVS ALLANTOIN .5 g/100g N 20181231 59779-438_141e3e67-a461-4728-8e37-9df4178a1d25 59779-438 HUMAN OTC DRUG Ibuprofen Dye Free Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 CVS Pharmacy IBUPROFEN 200 mg/1 N 20181231 59779-439_f8b48f0e-ddf4-41e2-969d-bbd5fd47e326 59779-439 HUMAN OTC DRUG Aspirin Low Strength, Enteric Aspirin TABLET, COATED ORAL 20130503 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 81 mg/1 N 20181231 59779-440_2c6037bb-e4c8-427b-9ab0-69b1456d6fbb 59779-440 HUMAN OTC DRUG CVS OIL FREE SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140620 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 59779-442_5369ac23-f9dc-4cb0-85a8-116228464981 59779-442 HUMAN OTC DRUG Long Acting Tussin Cough Gels Dextromethorphan HBr CAPSULE, GELATIN COATED ORAL 20060424 20180827 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 E 20171231 59779-443_6e70aab5-b755-2414-d094-4eab171570a7 59779-443 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150806 NDA NDA020076 CVS Pharmacy NICOTINE 7 mg/24h N 20181231 59779-444_62da3593-bd1a-90c1-e053-2991aa0a7b67 59779-444 HUMAN OTC DRUG CVS Maximum Strength Boil Relief Benzocaine OINTMENT TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. BENZOCAINE 20 g/100g N 20191231 59779-445_6e70aab5-b755-2414-d094-4eab171570a7 59779-445 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150806 NDA NDA020076 CVS Pharmacy NICOTINE 14 mg/24h N 20181231 59779-446_f81ba803-d700-4c37-849b-91f007232830 59779-446 HUMAN OTC DRUG Childrens Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 CVS Pharmacy LORATADINE 5 mg/5mL N 20181231 59779-447_f52c6c6a-cade-4ab6-a0e4-32e39c66a747 59779-447 HUMAN OTC DRUG Pain Relief Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050203 20201128 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 80 mg/1 N 20191231 59779-448_6e70aab5-b755-2414-d094-4eab171570a7 59779-448 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150806 NDA NDA020076 CVS Pharmacy NICOTINE 21 mg/24h N 20181231 59779-449_c5b7bf30-4be7-43ba-8c0e-509bcd95be91 59779-449 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/1 N 20181231 59779-450_03bf6731-c3b4-41b3-9541-50779b500775 59779-450 HUMAN OTC DRUG Junior Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20050225 20190223 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/1 N 20191231 59779-451_ae34f7d5-4990-4cef-a117-70221ad76d0f 59779-451 HUMAN OTC DRUG 3-In-1 Relief CVS Colloidal Oatmeal - 1.00% LOTION TOPICAL 20151130 OTC MONOGRAPH FINAL part347 CVS OATMEAL 1 g/100g N 20181231 59779-452_bc2b7b17-94ad-4db7-8727-d1c4fbdbf19a 59779-452 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20041206 20200403 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 80 mg/1 N 20181231 59779-453_cdd310c2-f895-4b7f-9f67-5f5709a8bd32 59779-453 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 20181020 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 E 20171231 59779-454_a922d401-3a67-4b4e-ad0e-0c5bc9f09ef2 59779-454 HUMAN OTC DRUG CVS - Childrens Stuffy Nose and Cold Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20150811 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 100; 2.5 mg/5mL; mg/5mL N 20181231 59779-455_abe3d532-619c-4737-9443-7db6c634bc0d 59779-455 HUMAN OTC DRUG SINUS PAIN AND CONGESTION Nighttime Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl TABLET, FILM COATED ORAL 20050628 20190708 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 E 20171231 59779-456_3230e700-00fc-408d-811f-fbe0ae889022 59779-456 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061026 ANDA ANDA076777 CVS Pharmacy NICOTINE 2 mg/1 N 20181231 59779-458_2f4a5028-9479-46f3-9434-cb4647654b9f 59779-458 HUMAN OTC DRUG Allergy Relief Indoor and Outdoor Allergies Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20090114 ANDA ANDA078336 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 59779-459_ce35af59-a7b7-4866-a3ec-225ed14b49e4 59779-459 HUMAN OTC DRUG nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20110812 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 59779-461_a9cacb04-bea1-4b4c-b91c-79aeb37cc6e6 59779-461 HUMAN OTC DRUG Flu HBP Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr TABLET, FILM COATED ORAL 20050601 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE 500; 15; 2 mg/1; mg/1; mg/1 N 20181231 59779-463_446175bb-8ac4-4de6-998e-fcbd1e2579aa 59779-463 HUMAN OTC DRUG allergy relief Chlorpheniramine Maleate TABLET ORAL 19870715 OTC MONOGRAPH FINAL part341 CVS Pharmacy CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 59779-465_2f173fc2-9649-4024-b52f-8ebc4a065b5a 59779-465 HUMAN OTC DRUG Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130603 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 59779-466_62b5d1f8-3bc8-4733-806a-9b3730608e39 59779-466 HUMAN OTC DRUG SINUS PAIN AND CONGESTION DAYTIME Acetaminophen and Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 59779-467_a0649a44-ec23-4f09-a389-437a0b81ed8c 59779-467 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 19920825 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 81 mg/1 N 20181231 59779-468_37e30616-56c4-4d3c-9436-d03f249ff280 59779-468 HUMAN OTC DRUG ESSENCE OF BEAUTY JAPANESE GARDEN ANTIBACTERIAL ETHYL ALCOHOL LIQUID TOPICAL 20120611 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 62 mL/100mL N 20181231 59779-469_92b7fa57-bd3a-4211-a430-8675447a8ad8 59779-469 HUMAN OTC DRUG CVS Extra Strength Cold and Hot Pain Relieving Menthol CREAM TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 CVS MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 59779-470_bddddfc8-2fdf-7e68-7422-1c1656705a87 59779-470 HUMAN OTC DRUG Head Congestion Cold Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20060611 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER, INCORPORATED ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 59779-472_b4b20b5b-0651-4f27-87a8-67fba6cb2b92 59779-472 HUMAN OTC DRUG Daytime Cold Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 59779-473_6012a1ca-ed31-f73c-c431-5bef413041e5 59779-473 HUMAN OTC DRUG Head Congestion Cold Relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20050721 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER, INCORPORATED ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 59779-474_80dc31f9-9c4c-477e-89b9-a827efb40391 59779-474 HUMAN OTC DRUG ESSENCE OF BEAUTY LILIES AND FREESIA ETHYL ALCOHOL LIQUID TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 620 mg/mL N 20181231 59779-475_602e6908-ee71-0ce2-e053-2a91aa0af04b 59779-475 HUMAN OTC DRUG CVS Extra Strength Cold and Hot Medicated Menthol PATCH TOPICAL 20130920 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. MENTHOL 750 mg/1 N 20181231 59779-476_c380eb3c-2081-479e-9a36-13e22e2b82e0 59779-476 HUMAN OTC DRUG CVS Ultra Strength Pain Relieving Menthol PATCH TOPICAL 20130920 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. MENTHOL 750 mg/1 E 20171231 59779-477_97e4374d-f7d9-4de1-9d42-c1e72ef8e778 59779-477 HUMAN OTC DRUG Baby Sunstick SPF 55 CVS Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0% Oxybenzone 6.0% STICK TOPICAL 20141223 OTC MONOGRAPH NOT FINAL part352 CVS AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59779-480_d8cbb9ce-97a0-4a16-b1ec-f915f253b472 59779-480 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090326 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 59779-481_cf0f12c7-323f-41b6-8ed9-a38b8266c188 59779-481 HUMAN OTC DRUG ESSENCE OF BEAUTY CITRUS COCONUTI ETHYL ALCOHOL LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 620 mg/mL N 20181231 59779-482_75bc2c60-d419-48f1-b4d7-46d5205d8e26 59779-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20120203 OTC MONOGRAPH FINAL part355 CVS Pharmacy, Inc SODIUM FLUORIDE .1 mg/mL N 20181231 59779-483_376eefed-ee1c-46b3-bd83-c1e208993986 59779-483 HUMAN OTC DRUG ESSENCE OF BEAUTY WIND KISSED ETHYL ALCOHOL LIQUID TOPICAL 20130702 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 620 mg/mL N 20181231 59779-484_b14e3a55-0218-48be-b370-20a798d48f68 59779-484 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 19910715 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 N 20181231 59779-485_ffd0ee4b-0e64-47c3-861a-0fa9ab27a18f 59779-485 HUMAN OTC DRUG ESSENCE OF BEAUTY VANILLA WISHES ETHYL ALCOHOL LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL N 20181231 59779-486_4fd34a5d-b035-49ed-9e73-e9653921b807 59779-486 HUMAN OTC DRUG Ear Drops Earwax Removal Aid CVS Carbamide Peroxide 6.5% LIQUID AURICULAR (OTIC) 20141224 OTC MONOGRAPH FINAL part344 CVS CARBAMIDE PEROXIDE 6.5 g/100mL N 20181231 59779-487_d8c3f873-c634-4544-9dba-ec98a17df16b 59779-487 HUMAN OTC DRUG Arthritis Reliev CVS Trolamine Salicylate 10% SPRAY TOPICAL 20140808 OTC MONOGRAPH NOT FINAL part348 CVS TROLAMINE SALICYLATE .1 g/100mL N 20181231 59779-488_9ce9f574-6925-4001-8819-b367acc050c1 59779-488 HUMAN OTC DRUG ESSENCE OF BEAUTY LILIES AND FREESIA ETHYL ALCOHOL LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 620 mg/mL N 20181231 59779-489_58211d72-d593-4a71-8656-ce40df8df6f2 59779-489 HUMAN OTC DRUG ESSENCE OF BEAUTY SUGAR FROSTED MINT ETHYL ALCOHOL LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL N 20181231 59779-491_acaa4610-c82a-4d0a-8fdf-fa30e3fdcf49 59779-491 HUMAN OTC DRUG Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130531 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-492_e6ba44de-b589-4b16-9254-d3117cf5509d 59779-492 HUMAN OTC DRUG Muscle Rub Ultra Strength CVS Camphor 4.00% Menthol 10.00% Methyl Salicylate 30.00% SPRAY TOPICAL 20141222 OTC MONOGRAPH NOT FINAL part348 CVS CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4; 10; 30 g/100g; g/100g; g/100g N 20181231 59779-493_3967c683-70db-418d-865c-5bfa51f84c33 59779-493 HUMAN OTC DRUG ESSENCE OF BEAUTY JAPANESE GARDEN ETHYL ALCOHOL LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 620 mg/mL N 20181231 59779-494_18daa05c-d3cf-4b98-b44e-fe12f166dcf7 59779-494 HUMAN OTC DRUG ESSENCE OF BEAUTY SNOWY APPLE ETHYL ALCOHOL LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL N 20181231 59779-495_dc31c80d-b551-4eaa-aded-3ab189ca3b5d 59779-495 HUMAN OTC DRUG CVS Moisturizing Lubricating Eye Twin Pack Carboxymethylcellulose Sodium Glycerin SOLUTION/ DROPS OPHTHALMIC 20140710 OTC MONOGRAPH FINAL part349 CVS Pharmacy, Inc. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 59779-496_d05ff791-57fd-46f5-93b5-a6f796be7d37 59779-496 HUMAN OTC DRUG CVS Long Lasting Lubricant Eye Twin Pack Polyethylene Glycol 400 Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20140710 OTC MONOGRAPH FINAL part349 CVS Pharmacy, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 59779-497_b076ac51-3d34-486d-a191-ba8abbc04f6c 59779-497 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20090505 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc COAL TAR 10.2 mg/mL N 20181231 59779-499_54994477-0fd4-43b3-ab33-0eb406e0e412 59779-499 HUMAN OTC DRUG Arthritis with Aloe CVS Trolamine Salicylate 10% CREAM TOPICAL 20141216 OTC MONOGRAPH NOT FINAL part348 CVS TROLAMINE SALICYLATE 10 g/100g N 20181231 59779-500_7f60a95d-81b2-431d-8490-ec89833e030e 59779-500 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid LIQUID TOPICAL 20140101 OTC MONOGRAPH FINAL part358B CVS Pharmacy SALICYLIC ACID .17 mg/15mL N 20181231 59779-501_ea0f92a1-6885-4a62-8c89-d820c6fab518 59779-501 HUMAN OTC DRUG Bacitracin bacitracin zinc OINTMENT TOPICAL 20060425 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN ZINC 500 [USP'U]/g N 20181231 59779-503_e3980f5f-d744-4268-a547-7b6c929e1b9b 59779-503 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080229 NDA NDA022032 CVS Pharmacy OMEPRAZOLE 20 mg/1 N 20181231 59779-504_804da9e6-05eb-4fb3-a138-b77801361b2c 59779-504 HUMAN OTC DRUG Sinus Wash SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION NASAL 20130401 UNAPPROVED DRUG OTHER CVS Pharmacy SODIUM BICARBONATE; SODIUM CHLORIDE 2300; 700 mg/1; mg/1 N 20181231 59779-505_74ed2f85-4eef-467e-b4a8-9afdf5d6df23 59779-505 HUMAN OTC DRUG NUANCE SALMA HAYAK Color and Correct CC Cream Broad Spectrum SPF 20 Sunscreen TITANIUM DIOXIDE CREAM TOPICAL 20141028 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy TITANIUM DIOXIDE 77 mg/mL E 20171231 59779-506_0674febe-577b-45a3-b1dc-44b4243a5e93 59779-506 HUMAN OTC DRUG Diabetic relief CVS Dimethicone - 1.0% LOTION TOPICAL 20151130 OTC MONOGRAPH FINAL part347 CVS DIMETHICONE 1 g/100g N 20181231 59779-507_ee329695-9211-491e-8e5d-8b2e91293de9 59779-507 HUMAN OTC DRUG Beauty 360 Antibacterial Moisturizing Body Wash Benzalkonium Chloride LIQUID TOPICAL 20160203 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-508_aac03106-806f-bc8c-056c-bed65497dd54 59779-508 HUMAN OTC DRUG Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI TABLET, EXTENDED RELEASE ORAL 20141119 ANDA ANDA076667 CVS Pharmacy FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60; 120 mg/1; mg/1 N 20181231 59779-509_0210f9e5-c35b-4cfa-92d1-48555e99f1f3 59779-509 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine HCl SOLUTION ORAL 20150922 ANDA ANDA204226 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 59779-510_2027129b-77d7-4b99-902d-b93c49909bc4 59779-510 HUMAN OTC DRUG CVS Pharmacy ITCH RELIEF ANTIFUNGAL Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C CVS Pharmacy CLOTRIMAZOLE 10 mg/g N 20181231 59779-511_396d4480-5951-498a-8d0b-e61eee7b38f5 59779-511 HUMAN OTC DRUG Tolnafate Foot and Sneaker Spray AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy TOLNAFTATE 1.3 g/113g N 20181231 59779-512_344e9c61-1f52-47b0-88b5-10c83b9cc7ec 59779-512 HUMAN OTC DRUG Severe Cough and Cold Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20170607 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 59779-513_8ade078b-f9d3-4108-b544-c5cecac56436 59779-513 HUMAN OTC DRUG Miconazole Nitrate Jock Itch Spray AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 1.3 g/131g N 20181231 59779-514_816a6ca0-8474-4859-9987-bd63c0f6f007 59779-514 HUMAN OTC DRUG CVS Antifungal Ringworm Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C CVS Pharmacy CLOTRIMAZOLE 1 g/100g N 20181231 59779-515_5177d4cd-3517-468b-95de-065389b7089a 59779-515 HUMAN OTC DRUG Sinus Relief Severe Congestion Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140630 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 59779-516_1f16082b-6125-4fea-8a87-3bfc6b1049b7 59779-516 HUMAN OTC DRUG Tussin CF Adult Cough and Cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20060721 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 59779-517_eb225796-d3ea-4b02-80e0-a877becf11b8 59779-517 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20060427 ANDA ANDA077349 CVS Pharmacy IBUPROFEN 200 mg/1 N 20181231 59779-519_69344a63-3c01-4a89-b9dd-5be4757f996d 59779-519 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 N 20181231 59779-520_1525cd5b-5f36-4a89-95c1-d6b211ff49c4 59779-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100708 NDA NDA021855 CVS Pharmacy LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 59779-521_7b9d2bde-6df9-47d2-b85b-4d83bbc5f47c 59779-521 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 19911105 ANDA ANDA076359 CVS Pharmacy IBUPROFEN 100 mg/1 N 20181231 59779-522_6211a92b-b66c-4ac2-e053-2a91aa0a3c49 59779-522 HUMAN OTC DRUG CVS ATHLETES FOOT TOLNAFTATE TOLNAFTATE CREAM TOPICAL 20141010 OTC MONOGRAPH FINAL part333C CVS PHARMACY TOLNAFTATE 10 mg/g N 20191231 59779-523_f9000900-799e-4e6f-b764-f5a6c16c72f9 59779-523 HUMAN OTC DRUG CVS Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 CVS Pharmacy TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 59779-526_ac825d18-735f-6052-46fa-14a834979c8c 59779-526 HUMAN OTC DRUG Severe Cold Relief PE Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET, FILM COATED ORAL 20050621 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER, INCORPORATED ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 59779-527_3430eb66-404c-4df7-9eb2-4e37e739df0c 59779-527 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070927 ANDA ANDA077153 CVS Pharmacy LORATADINE 10 mg/1 N 20181231 59779-528_5d31eb99-1e69-455f-aef2-8c644da326ad 59779-528 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20100108 ANDA ANDA076134 CVS Pharmacy LORATADINE 10 mg/1 N 20181231 59779-529_6ddf7908-7f69-4c8d-9f45-7c82d9bf9180 59779-529 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20130822 OTC MONOGRAPH FINAL part332 CVS Pharmacy DIMETHICONE 180 mg/1 N 20181231 59779-530_325223b2-efee-49b6-822f-3b913c31ad2e 59779-530 HUMAN OTC DRUG Multi-Symptom Cold Relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCl KIT 20050715 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-531_b1b073ba-bfe9-4584-aed3-827ec1b93069 59779-531 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 N 20181231 59779-532_c09b6d9e-f6d4-4b3f-9b5a-87a900532a66 59779-532 HUMAN OTC DRUG Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20061026 ANDA ANDA076779 CVS Pharmacy NICOTINE 4 mg/1 N 20181231 59779-534_f1e8fab8-7a37-45a6-a944-82b83c93551e 59779-534 HUMAN OTC DRUG CVS Motion Sickness Fast Melting meclizine hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20150827 OTC MONOGRAPH FINAL part336 CVS Pharmacy, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 59779-535_280eafc2-bfdf-4bce-a24c-c55b07ff9d87 59779-535 HUMAN OTC DRUG CVS Natural Fiber Effervescent Psyllium Husk POWDER ORAL 20140228 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy PSYLLIUM HUSK 3.4 g/5.8g N 20181231 59779-537_9b1ade7e-a9df-46c0-a84f-9be8bef189ec 59779-537 HUMAN OTC DRUG CVS Bacitracin with Pain Relief BACITRACIN and LIDOCIANE OINTMENT TOPICAL 20100708 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN; LIDOCAINE 600; 40 [USP'U]/g; mg/g E 20171231 59779-538_1d0fc7e7-c10d-4b4b-e054-00144ff88e88 59779-538 HUMAN OTC DRUG Pinworm Treatment Pyrantel pamoate SUSPENSION ORAL 20150811 OTC MONOGRAPH FINAL part357B CVS Pharmacy Inc. PYRANTEL PAMOATE 144 mg/mL N 20181231 59779-539_e8267f84-5827-4f22-8c01-75d453278e59 59779-539 HUMAN OTC DRUG Childrens Cough and Cold Nighttime Diphenhydramine HCl, Phenylephrine HCl SOLUTION ORAL 20150722 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 59779-540_3541fb1b-5016-4c6d-b59c-a6602a9a77b5 59779-540 HUMAN OTC DRUG acid reducer Ranitidine TABLET, FILM COATED ORAL 20150914 ANDA ANDA091429 CVS Pharmacy RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 59779-542_b5add68f-6cc0-465d-8541-7be7d33c3829 59779-542 HUMAN OTC DRUG Colic Relief Aloe, Carbo Vegetabilis, Carum Carvi, Chamomilla, Foeniculum Vulgare, Melissa Officinale, Mentha Piperita, Prunus Spinosa, Zingiber Officinale LIQUID ORAL 20151110 UNAPPROVED HOMEOPATHIC CVS Pharmacy ALOE; ACTIVATED CHARCOAL; CARAWAY SEED; MATRICARIA RECUTITA; FENNEL SEED; MELISSA OFFICINALIS; MENTHA PIPERITA; PRUNUS SPINOSA FLOWER BUD; GINGER 5; 1; 5; 5; 5; 5; 5; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 59779-543_9ea5d578-88b7-487a-94fe-3a0d88b9d6cd 59779-543 HUMAN OTC DRUG Severe Allergy And Sinus Headache Maximum Strength Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET, FILM COATED ORAL 20070627 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 59779-544_7977f48b-7a50-4ab9-9735-68f8860fa745 59779-544 HUMAN OTC DRUG arthritis pain relief temporary minor Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000531 ANDA ANDA075077 CVS Pharmacy ACETAMINOPHEN 650 mg/1 N 20181231 59779-545_3c54974d-9d16-2fa1-e054-00144ff88e88 59779-545 HUMAN OTC DRUG cherry sore throat lozenge Benzocaine LOZENGE ORAL 20150518 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 59779-547_ad48f6bf-ea01-4aca-957a-5b5be214671a 59779-547 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20150731 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 59779-548_40181b9d-c9cc-4e3c-87fc-78eed30a03c6 59779-548 HUMAN OTC DRUG Non-Drying Sinus PE Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20030917 20190708 OTC MONOGRAPH FINAL part341 CVS Pharmacy GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 200; 5 mg/1; mg/1 E 20171231 59779-549_defb52fb-f92d-4869-aaaf-b44089cb28ae 59779-549 HUMAN OTC DRUG Minoxidil Minoxidil SOLUTION TOPICAL 20141007 ANDA ANDA075598 CVS Pharmacy MINOXIDIL 3 g/60mL N 20181231 59779-551_960cc100-4427-426a-b3f7-f305a68700e4 59779-551 HUMAN OTC DRUG CVS Medicated Pain Relieving Camphor, Menthol, Menthyl Salicylate PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 28.4; 131; 144 mg/1; mg/1; mg/1 N 20181231 59779-552_f2702abc-a740-4f9f-8cdd-b83922296f37 59779-552 HUMAN OTC DRUG Eye Allergy Relief Pheniramine Maleate and Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20150701 NDA NDA020065 CVS Pharmacy NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL N 20181231 59779-553_602cde38-1ee6-f347-e053-2991aa0acf74 59779-553 HUMAN OTC DRUG Leg Cramps aconitum napellus, cinchona officinalis bark, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top TABLET ORAL 20160210 UNAPPROVED HOMEOPATHIC CVS Pharmacy ACONITUM NAPELLUS; CINCHONA OFFICINALIS BARK; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP 6; 3; 3; 6; 6; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59779-554_036857b9-57a2-475c-9eba-ddd50814333f 59779-554 HUMAN OTC DRUG Daytime Nighttime Sinus Relief Maximum Strength Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl,Guaifenesin KIT 20160531 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-555_3391d9ad-c694-4588-9fe0-6a832d506815 59779-555 HUMAN OTC DRUG Sinus PE Pressure, Pain plus Cough Multi-Symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20140731 20200605 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 59779-556_f06708f9-bcb3-4c6c-bce2-ba70080569ca 59779-556 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 59779-557_ab0bf183-a7a8-4815-8d6d-60dec4c5fb2d 59779-557 HUMAN OTC DRUG Tussin DM Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20100728 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 59779-558_3b0a396f-12cb-47c4-a608-72d0eaab1fba 59779-558 HUMAN OTC DRUG SINUS PAIN AND CONGESTION DAYTIME Acetaminophen and Phenylephrine HCl TABLET ORAL 20080317 20190708 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 E 20171231 59779-560_ee2ffab9-98fe-4948-9840-d98a409bf98c 59779-560 HUMAN OTC DRUG Cold Relief Multi-symptom, Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20080329 20190211 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 59779-562_2bd56613-0d97-2df4-e054-00144ff8d46c 59779-562 HUMAN OTC DRUG CVS Total Home Antibacterial moist wipes with natural aloe SWAB TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A cvs pharmacy BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 59779-563_75e9848c-0230-4bcf-abdb-91be23b86c20 59779-563 HUMAN OTC DRUG muscle rub Menthol, Methyl salicylate CREAM TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g N 20181231 59779-564_e03f3900-bbbb-4ed6-91b8-8f8dfbd9f565 59779-564 HUMAN OTC DRUG Daytime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl,Guaifenesin KIT 20160531 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-565_2e0f1681-9b1c-48c7-b7b1-40ae0c02a152 59779-565 HUMAN OTC DRUG Pain Relief CVS Lidocaine CREAM TOPICAL 20160315 OTC MONOGRAPH NOT FINAL part348 CVS LIDOCAINE 4 g/100g N 20181231 59779-566_a8f95400-1825-4284-9e52-7c90a1b2c3b9 59779-566 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20090105 OTC MONOGRAPH FINAL part347 CVS Pharmacy PETROLATUM 1 g/g N 20181231 59779-567_281af40d-437b-4f0a-acd7-0650bd9b8150 59779-567 HUMAN OTC DRUG daytime nighttime multi symptom cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20120727 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-568_5aa80253-a728-26fc-e053-2a91aa0adc23 59779-568 HUMAN OTC DRUG Earache Belladonna, Calcarea Carbonica, Chamomilla, Lycopodium Clavatum, Pulsatilla (Vulgaris), Sulphur LIQUID AURICULAR (OTIC) 20160422 UNAPPROVED HOMEOPATHIC CVS Pharmacy ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA RECUTITA; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SULFUR 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 59779-569_e0ac3dc4-0a32-4e33-9f38-4bcccef210f3 59779-569 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358F CVS Pharmacy SALICYLIC ACID 40 mg/41 N 20181231 59779-570_2b96b2b5-cad0-4791-be6e-2a6c335a0304 59779-570 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358F CVS Pharmacy SALICYLIC ACID 40 mg/91 N 20181231 59779-571_5c616c4c-d78a-4cff-aad7-7f8e682f78f6 59779-571 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20090109 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 59779-572_e8fff698-1848-4725-9611-26f37542bc9e 59779-572 HUMAN OTC DRUG Tolnaftate Antifungal Continuous Liquid Spray AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH FINAL part333C CVS Pharmacy TOLNAFTATE 1.5 g/150g N 20181231 59779-573_2781042d-b9fc-1883-e054-00144ff8d46c 59779-573 HUMAN OTC DRUG Medicated wipes Maximum srenght formula Specially formulated for new moms SWAB TOPICAL 20150301 OTC MONOGRAPH FINAL part346 CVS pharmacy WITCH HAZEL .5 g/g N 20181231 59779-575_46f38f27-0ee0-4abb-a893-5bc4fe0a4794 59779-575 HUMAN OTC DRUG Senna plus DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 59779-576_b45c8bd5-1534-4e76-a5de-6c332e8a4cbf 59779-576 HUMAN OTC DRUG Oral Antivavity Sodium fluoride MOUTHWASH ORAL 20130208 OTC MONOGRAPH FINAL part355 CVS Pharmacy SODIUM FLUORIDE 10.41 mg/mL N 20181231 59779-577_d6e27133-99c8-4343-bd95-d854f2874771 59779-577 HUMAN OTC DRUG CVS Effervescent Pain Relief PM Acetaminophen and Diphenhydramine TABLET ORAL 20150202 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 59779-579_c2e3b962-4203-44e4-894c-28e9011c1166 59779-579 HUMAN OTC DRUG fever reducing childrens Acetaminophen SUPPOSITORY RECTAL 20100121 ANDA ANDA070607 CVS Pharmacy ACETAMINOPHEN 120 mg/1 N 20181231 59779-580_c15042d5-cc3e-40f7-9eb4-1cdf56f8e7c5 59779-580 HUMAN OTC DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150327 NDA NDA022032 CVS Pharmacy OMEPRAZOLE 20 mg/1 N 20181231 59779-582_54f4c061-d10c-480f-a458-8aabb05642e4 59779-582 HUMAN OTC DRUG CVS Pharmacy Maximum Strength Benzocaine GEL, DENTIFRICE ORAL 20110120 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g N 20181231 59779-583_eb153f3a-5618-4574-94d8-51b5bbbe5ac9 59779-583 HUMAN OTC DRUG Allergy and Cold Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl CAPSULE, GELATIN COATED ORAL 20090710 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 59779-584_b1874174-a551-4111-b251-7810ca886d17 59779-584 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative Docusate sodium, Sennosides TABLET ORAL 20151031 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 59779-585_16cda477-2964-4ee6-9d85-59403d3c1768 59779-585 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine HCl TABLET, CHEWABLE ORAL 20090320 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20181231 59779-586_e7decc39-947c-467a-8f99-83159fe4801d 59779-586 HUMAN OTC DRUG Senna Sennosides TABLET ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SENNOSIDES 8.6 mg/1 N 20181231 59779-587_72c3c0b2-feda-4a27-b225-1e2ff8f995ff 59779-587 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20160229 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 125 mg/1 N 20181231 59779-588_2ff99437-1058-56fc-e054-00144ff88e88 59779-588 HUMAN OTC DRUG Vagicaine Maximum Strength Anti-Itch Cream Benzocaine, Resorcinol CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy BENZOCAINE; RESORCINOL 5.6; .84 g/28g; g/28g N 20181231 59779-589_a7212ebc-8dbd-4f01-a8f9-0ca58b7abf29 59779-589 HUMAN OTC DRUG Dandruff Selenium sulfide SHAMPOO TOPICAL 20121209 OTC MONOGRAPH FINAL part358H CVS SELENIUM SULFIDE 10 mg/mL N 20181231 59779-590_a78a8af5-323a-434f-a4bb-09a327bde35c 59779-590 HUMAN OTC DRUG infants pain and fever acetaminophen SUSPENSION ORAL 19930430 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL N 20181231 59779-592_9141119c-6168-4549-b8ec-765eb44f202e 59779-592 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SENNOSIDES 25 mg/1 N 20191231 59779-593_f6cead19-44dc-41bf-811d-8f7a302d0128 59779-593 HUMAN OTC DRUG Hand Sanitizer alcohol GEL TOPICAL 20150123 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ALCOHOL 567 mg/mL N 20181231 59779-594_9738088d-5db7-4fff-b1e4-2723dae586d6 59779-594 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20160630 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 59779-595_3c187075-e285-00cc-e054-00144ff8d46c 59779-595 HUMAN OTC DRUG berry breezer throat drops pectin LOZENGE ORAL 20150518 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy PECTIN 7 mg/1 N 20181231 59779-596_1468a438-f40e-4705-b132-1b43861f2f51 59779-596 HUMAN OTC DRUG Antacid Childrens Calcium Carbonate TABLET, CHEWABLE ORAL 20110407 OTC MONOGRAPH FINAL part331 CVS Pharmacy CALCIUM CARBONATE 400 mg/1 N 20181231 59779-597_1660e1b0-2c51-40d3-b55c-36d090fca814 59779-597 HUMAN OTC DRUG Severe Nighttime Severe Daytime acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl KIT 20131227 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-598_36e4e7d3-cfeb-4f57-89c8-c97db91b59ed 59779-598 HUMAN OTC DRUG CVS PHARMACY CALMING DAILY MOISTURIZER AVOBENZONE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20151116 OTC MONOGRAPH NOT FINAL part352 CVS PHARMACY AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL N 20181231 59779-599_aa6d244e-981f-4b71-98e2-ba4481702a6b 59779-599 HUMAN OTC DRUG Sinus PE Pressure, Pain and Cold Daytime, Non-Drowsy Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20070222 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 59779-600_9933e9b6-3612-426d-939f-66d094c4c6df 59779-600 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 81 mg/1 N 20181231 59779-601_14252d4b-9165-418b-b14d-3c179acbaa48 59779-601 HUMAN OTC DRUG ILLUMINATING DAILY MOISTURIZER SPF 15 AVOBENZONE LOTION TOPICAL 20100804 OTC MONOGRAPH FINAL part352 CVS PHARMACY INC AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 2 mL/100mL; mL/100mL; mL/100mL N 20181231 59779-602_2e5229b5-cad5-4bb6-8790-923d77b639fd 59779-602 HUMAN OTC DRUG CVS PHARMACY ILLUMINATING AVOBENZONE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20130610 OTC MONOGRAPH FINAL part352 CVS PHARMACY AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 20 mg/mL; mg/mL; mg/mL N 20181231 59779-603_b0cfb2d5-2243-457b-8393-c4693417422f 59779-603 HUMAN OTC DRUG Severe Daytime acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20131227 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 59779-604_7f4342ec-4a5d-4ad0-8a82-ac97b32b12f9 59779-604 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20010710 ANDA ANDA072096 CVS Pharmacy IBUPROFEN 200 mg/1 N 20181231 59779-605_2539dd99-c99f-492a-a35f-e1af9333958c 59779-605 HUMAN OTC DRUG Aspirin Low Dose Sugar Free Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 81 mg/1 N 20191231 59779-607_277e638d-0802-0dbd-e054-00144ff88e88 59779-607 HUMAN OTC DRUG Medicated Wipes Hemorrhoidal Wipes with Witch Hazel Witch Hazel CLOTH TOPICAL 20100101 OTC MONOGRAPH FINAL part346 CVS Pharmacy WITCH HAZEL .5 g/g N 20181231 59779-608_4026e7b1-99ad-4de2-a65d-21e6cd8cf532 59779-608 HUMAN OTC DRUG Antibacterial Moist Wipes Benzalkonium Chloride CLOTH TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 59779-609_5449b57f-53c9-4028-87a7-cd70c9ba88a3 59779-609 HUMAN OTC DRUG Antibacterial Moist Wipes Benzalkonium Chloride CLOTH TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE .24 mg/mL N 20181231 59779-610_710a6dff-4a6b-4ff5-8bae-790c49102776 59779-610 HUMAN OTC DRUG ANTIDANDRUFF MEDICATED SELENIUM SULFIDE SHAMPOO TOPICAL 20100706 OTC MONOGRAPH FINAL part358 CVS PHARMACY INC SELENIUM SULFIDE 1 mL/100mL N 20181231 59779-611_4be32790-db32-4a5f-a90b-004923f4757b 59779-611 HUMAN OTC DRUG CVS Pharmacy Dandruff Moisturizing with Aloe Selenium Sulfide SHAMPOO TOPICAL 20101015 OTC MONOGRAPH FINAL part358H CVS Pharmacy Inc SELENIUM SULFIDE 1 mL/100mL N 20181231 59779-612_4098e5fe-16ba-48af-b76c-56755e439539 59779-612 HUMAN OTC DRUG allergy relief Loratadine TABLET ORAL 20050104 ANDA ANDA076301 CVS Pharmacy LORATADINE 10 mg/1 N 20181231 59779-613_eda9987b-6e24-4b82-8189-02258e3a179c 59779-613 HUMAN OTC DRUG CVS Medicated Chest Rub Roll-On Camphor, Eucalyptus Oil, Menthol GEL TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100mL; g/100mL; g/100mL N 20181231 59779-614_936dd7eb-f6f2-4637-8ce3-ad2438ce776b 59779-614 HUMAN OTC DRUG Allergy Relief Dye-Free Diphenhydramine HCl TABLET ORAL 20130207 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59779-616_c9cc0ea8-23bf-4f3d-9e6d-eace9759ea38 59779-616 HUMAN OTC DRUG stomach relief original Bismuth subsalicylate SUSPENSION ORAL 19920616 OTC MONOGRAPH FINAL part335 CVS Pharmacy BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 59779-617_3d0870d3-a14a-2b45-e054-00144ff8d46c 59779-617 HUMAN OTC DRUG CVS pharmacy Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy ALCOHOL .659 mL/mL N 20181231 59779-619_9eb3d710-f1bb-443a-b3bd-5ea22990e390 59779-619 HUMAN OTC DRUG CVS PHARMACY MEDICATED SELENIUM SULFIDE LIQUID TOPICAL 20130708 OTC MONOGRAPH FINAL part358H CVS PHARMACY SELENIUM SULFIDE 10 mg/mL N 20181231 59779-620_8dca210f-2446-4e8c-9071-9e9d909ee089 59779-620 HUMAN OTC DRUG CVS Extra Strength Pain Relief MENTHOL, METHYL SALICYLATE GEL TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL; METHYL SALICYLATE 76; 290 mg/g; mg/g E 20171231 59779-621_c3d98a66-fe5d-4989-801b-31e58c563095 59779-621 HUMAN OTC DRUG CVS Medicated Anti-Itch MENTHOL, PRAMOXINE HYDROCHLORIDE CREAM TOPICAL 20100708 OTC MONOGRAPH FINAL part347 CVS Pharmacy PRAMOXINE HYDROCHLORIDE; MENTHOL 10; 10 mg/g; mg/g E 20171231 59779-622_fb869713-a2be-4644-bbf2-6e894ea30fef 59779-622 HUMAN OTC DRUG CVS Capsaicin CAPSAICIN CREAM ORAL 20100708 OTC MONOGRAPH FINAL part348 CVS Pharmacy CAPSAICIN 75 mg/g E 20171231 59779-623_388b1a39-daa4-425f-96e1-1c96896c8d5f 59779-623 HUMAN OTC DRUG Motion Sickness II Meclizine HCl TABLET ORAL 20131230 OTC MONOGRAPH FINAL part336 CVS Pharmacy MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 59779-624_6d373e47-f918-444a-b3bb-bce99b42d502 59779-624 HUMAN OTC DRUG Kids Disappearing Color SPF50 Broad Spectrum Suncreen Pink Strawberry Scented Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 10; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 59779-625_3c43aba0-9d6c-51a2-e054-00144ff8d46c 59779-625 HUMAN OTC DRUG Throat Relief Pops Pectin LOZENGE ORAL 20150518 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy PECTIN 10 mg/1 N 20181231 59779-626_43b04623-f000-4efb-88b9-f7f56fd99ede 59779-626 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, GELATIN COATED ORAL 20130422 20180827 OTC MONOGRAPH NOT FINAL part334 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DOCUSATE SODIUM 100 mg/1 E 20171231 59779-627_1fb192d3-92a0-40f7-a003-864618c04052 59779-627 HUMAN OTC DRUG Ketotifen Fumarate Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20131108 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .35 mg/mL N 20181231 59779-628_2782a36f-1f23-4dff-e054-00144ff8d46c 59779-628 HUMAN OTC DRUG CVS pharmacy Instant Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy ALCOHOL .659 mL/mL N 20181231 59779-629_dbbd69e5-c508-4140-9b5c-4d831d082f77 59779-629 HUMAN OTC DRUG Motion Sickness Original Formula Dimenhydrinate TABLET ORAL 20140415 OTC MONOGRAPH FINAL part336 CVS Pharmacy DIMENHYDRINATE 50 mg/1 N 20181231 59779-630_92587e9b-8e2e-494d-8baf-0e6b44ad6b39 59779-630 HUMAN OTC DRUG CVS Pharmacy Maximum Strength Benzocaine GEL, DENTIFRICE ORAL 20130701 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g N 20181231 59779-631_09bc40df-c97a-48bb-911b-e74c4166776a 59779-631 HUMAN OTC DRUG Severe Daytime acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20131227 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 59779-632_be588e7e-cf61-4c8f-81ec-b2a9ee04d8f7 59779-632 HUMAN OTC DRUG C-Lax Laxative Bisacodyl TABLET, SUGAR COATED ORAL 20050212 20181214 OTC MONOGRAPH NOT FINAL part334 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED BISACODYL 5 mg/1 E 20171231 59779-633_2bd56a80-5d25-3815-e054-00144ff8d46c 59779-633 HUMAN OTC DRUG CVS Health Antibacterial Hand Wipes with Benzalkonium Chloride SWAB TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A cvs pharmacy BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 59779-634_72efd514-5cb9-4b24-8ccd-58fcd34b0a80 59779-634 HUMAN OTC DRUG childrens multi symptom cold dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20160611 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 59779-635_dc5c0d82-48b6-483c-a724-62be667e5439 59779-635 HUMAN OTC DRUG Miconazole Nitrate Antifungal Powder Moisture Absorbing POWDER TOPICAL 20120104 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 1.42 g/71g N 20181231 59779-636_d81a2ee4-df56-4e12-ae79-1ebaa9390f05 59779-636 HUMAN OTC DRUG CVS Health Maximum Strength Antacid and Antigas TABLET, CHEWABLE ORAL 20150914 OTC MONOGRAPH FINAL part332 CVS Pharmacy,Inc. CALCIUM CARBONATE; DIMETHICONE 1000; 60 mg/1; mg/1 N 20181231 59779-637_49c86b5f-7b7d-4825-8138-1d8ce4cd1d6b 59779-637 HUMAN OTC DRUG nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20140718 ANDA ANDA091349 CVS Pharmacy NICOTINE 2 mg/1 N 20181231 59779-638_22126112-18d8-1cf7-e054-00144ff8d46c 59779-638 HUMAN OTC DRUG CVSHealth Childrens Allergy Relief Pops CHLORPHENIRAMINE MALEATE LOZENGE ORAL 20151013 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. CHLORPHENIRAMINE MALEATE 2 mg/1 N 20181231 59779-639_2423908d-2716-4390-e054-00144ff88e88 59779-639 HUMAN OTC DRUG Green Apple Cough Drops MENTHOL, UNSPECIFIED FORM LOZENGE ORAL 20151109 OTC MONOGRAPH FINAL part341 CVS MENTHOL, UNSPECIFIED FORM 2.6 mg/1 N 20181231 59779-641_42ddb00f-940a-46b4-a9ac-60648cc58ae0 59779-641 HUMAN OTC DRUG CVS Health Hydrating PETROLATUM OINTMENT TOPICAL 20150430 OTC MONOGRAPH FINAL part347 CVS Pharmacy PETROLATUM .041 g/.1g N 20181231 59779-642_929b711c-2a6d-4c1f-976d-a315a01e4266 59779-642 HUMAN OTC DRUG INFANTS TEETHING LIQUID CHAMOMILLA, ARNICA MONTANA, BORAX, HYPERICUM PERFORATUM LIQUID ORAL 20140225 UNAPPROVED HOMEOPATHIC CVS PHARMACY CHAMOMILE; ARNICA MONTANA; SODIUM BORATE; HYPERICUM PERFORATUM 5; 5; 5; 5 [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL N 20181231 59779-643_a120359d-4798-41c8-97c1-e7e4739882cf 59779-643 HUMAN OTC DRUG INFANTS GAS AND COLIC RELIEF COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA LIQUID ORAL 20140219 UNAPPROVED HOMEOPATHIC CVS PHARMACY CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC; CHAMOMILE; DIOSCOREA VILLOSA ROOT 6; 6; 6; 6 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 59779-644_3c55009c-4b3f-135e-e054-00144ff8d46c 59779-644 HUMAN OTC DRUG honey lemon sore throat lozenges Benzocaine LOZENGE ORAL 20150518 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy BENZOCAINE; MENTHOL 15; 2.6 mg/1; mg/1 N 20181231 59779-645_35a035fa-1cbb-41a8-8850-e6a7d6cd03b3 59779-645 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl SUSPENSION ORAL 20120228 ANDA ANDA091292 CVS Pharmacy LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 59779-646_2a56e4bd-f96e-4cbb-945e-f23ae9603052 59779-646 HUMAN OTC DRUG Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20160430 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-647_aaacdcdf-4c31-4f94-872e-0821bd330bdb 59779-647 HUMAN OTC DRUG ibuprofen Ibuprofen TABLET, COATED ORAL 20010731 ANDA ANDA072096 CVS Pharmacy IBUPROFEN 200 mg/1 N 20181231 59779-648_60df1ffc-e89d-417b-9e12-ac842dc395d1 59779-648 HUMAN OTC DRUG Severe Congestion and Cough Multi-Symptom Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20150720 OTC MONOGRAPH FINAL part341 CVS Pharmacy GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 200; 5; 10 mg/1; mg/1; mg/1 N 20181231 59779-649_770201f8-0e29-4771-bc3c-f9bb0438cba0 59779-649 HUMAN OTC DRUG CVS Sore Throat Mixed Berry Flavor BENZOCAINE, DEXTROMETHORPHAN HYDROBROMIDE LOZENGE ORAL 20140422 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc. BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20181231 59779-650_b05f1b19-7272-4c32-bacc-69ad584d2b7d 59779-650 HUMAN OTC DRUG tussin adult chest congestion Guaifenesin SYRUP ORAL 19870715 OTC MONOGRAPH FINAL part341 CVS Pharmacy GUAIFENESIN 200 mg/10mL N 20181231 59779-651_c0bb1db6-3648-4ba5-878e-515c11cbbd66 59779-651 HUMAN OTC DRUG Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130630 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 59779-653_3ad5b2ff-3adc-05c2-e054-00144ff8d46c 59779-653 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 5.4 mg/1 N 20181231 59779-653_3ae6e278-ef2a-6f28-e054-00144ff88e88 59779-653 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 5.4 mg/1 N 20181231 59779-653_3ae87ace-176d-54b7-e054-00144ff8d46c 59779-653 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 5.4 mg/1 N 20181231 59779-654_49516a11-e910-4ce0-be95-f9f6e78b9df5 59779-654 HUMAN OTC DRUG Daytime Nighttime Severe Cough and Cold Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl KIT 20150915 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-655_2db57bff-e3fc-6fc4-e054-00144ff88e88 59779-655 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 5.8 mg/1 N 20181231 59779-655_3ae95b6c-b2f7-0a69-e054-00144ff8d46c 59779-655 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 5.8 mg/1 N 20181231 59779-655_3aeb727e-76f1-70f5-e054-00144ff8d46c 59779-655 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 5.8 mg/1 N 20181231 59779-656_7f2ae9f9-32ff-446d-8535-92384d1a5847 59779-656 HUMAN OTC DRUG Daytime acetaminophen, dextromethorphan hbr, phenylephrine hcl SOLUTION ORAL 20060609 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20191231 59779-657_1f6bd520-95f0-4860-ba2e-a7ea1e2cde7b 59779-657 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20150301 20201207 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 N 20191231 59779-658_613dac91-0fe6-43b1-b1bf-b57b18766882 59779-658 HUMAN OTC DRUG Allergy Relief Dye-Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59779-659_3afa9355-02f2-5ec8-e054-00144ff8d46c 59779-659 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 7.5 mg/1 N 20181231 59779-659_3afce017-20c7-07c6-e054-00144ff88e88 59779-659 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 7.5 mg/1 N 20181231 59779-659_3afdfbd6-fcd8-4a7a-e054-00144ff8d46c 59779-659 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 7.5 mg/1 N 20181231 59779-659_3c6a400b-e371-2f9e-e054-00144ff88e88 59779-659 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 7.5 mg/1 N 20181231 59779-660_758d39f1-71a0-4321-aa01-670e99b1891e 59779-660 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 20020904 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL N 20181231 59779-661_41524cba-b79a-4f94-81e5-0ad3bb843918 59779-661 HUMAN OTC DRUG CVS Pharmacy Daytime Nighttime Severe Cold and Cough Kit Acetaminophen, Diphenhydramine HCL, Phenylephrine HCL and Dextromethorphan HBr KIT 20130619 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-662_bfad5c8d-43d3-4b30-86bd-0da00d7857f2 59779-662 HUMAN OTC DRUG Tussin Cough Non-Drowsy Liquidgels Dextromethorphan HBr CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 59779-663_3bdc9143-2c92-2725-e054-00144ff88e88 59779-663 HUMAN OTC DRUG strawberry cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 2.7 mg/1 N 20181231 59779-664_5776c4a1-1ac1-4523-b909-2efb26032f85 59779-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19920915 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 59779-665_9333a5c0-7e2c-4a0f-8210-475b96f68876 59779-665 HUMAN OTC DRUG Instant Hand Sanitizer Wipes Benzalkonium Chloride CLOTH TOPICAL 20151002 OTC MONOGRAPH NOT FINAL part333E CVS BENZALKONIUM CHLORIDE; .ALPHA.-TOCOPHEROL ACETATE, DL- .13; 1 mg/100mL; mg/100mL N 20181231 59779-667_a424b3f6-ad6e-46c0-bea1-a888e02af129 59779-667 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 19890715 OTC MONOGRAPH FINAL part334 CVS Pharmacy MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 59779-668_35c29a8c-b183-406e-b108-77a42b07fa4c 59779-668 HUMAN OTC DRUG nighttime cough Dextromethorphan Hydrobromide, Doxylamine Succinate SOLUTION ORAL 20020923 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 59779-669_9000e993-146d-4937-a0a7-fd47cc590c78 59779-669 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20140227 OTC MONOGRAPH FINAL part346 CVS Pharmacy MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 59779-670_6fa8c6d5-fb6f-4b1f-8672-4ec8389bd57b 59779-670 HUMAN OTC DRUG CVS Burn Relief w/Lido 8oz Lidocaine HCl GEL TOPICAL 20150708 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 59779-671_9be1b4a2-106b-4b26-825b-00ced9a56e70 59779-671 HUMAN OTC DRUG Night Time Cold and Flu Relief Multi Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20150930 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 59779-672_522b1fbd-4389-4fee-9c05-69b615e5990d 59779-672 HUMAN OTC DRUG Warming Epsom Rub Menthol GRANULE, FOR SOLUTION TOPICAL 20150505 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL 11.7 mg/mL N 20181231 59779-674_0346b3bb-5daf-4a8d-a1b1-0653a1c33c2f 59779-674 HUMAN OTC DRUG CVS SPF 30 Sport AVOBENZONE, HOMOSALATE, OCTOCRYLENE SPRAY TOPICAL 20151020 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTOCRYLENE 2; 7; 5 g/100g; g/100g; g/100g N 20181231 59779-675_e1ca7cd8-abe0-46b3-9c63-962b927bfcdb 59779-675 HUMAN OTC DRUG CVS Health Ultra Strength Natural Antacid Peppermint Flavor Antacid Tablets TABLET, CHEWABLE ORAL 20150817 OTC MONOGRAPH FINAL part331 CVS Pharmacy,Inc. CALCIUM CARBONATE 1000 mg/1 N 20181231 59779-676_79f242cf-ae5b-435d-b7b1-e2442b2b3ab1 59779-676 HUMAN OTC DRUG C-Lax Laxative Bisacodyl TABLET, COATED ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy BISACODYL 5 mg/1 N 20181231 59779-677_167134bc-204d-4685-8501-e0ae30b9eb2b 59779-677 HUMAN OTC DRUG Cold and Flu Relief Non-Drowsy / Daytime Severe / Nighttime Severe Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Guaifenesin, Phenylephrine HCl KIT 20150801 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-680_3c16ed6e-42a1-1ecb-e054-00144ff8d46c 59779-680 HUMAN OTC DRUG herbal cough drops menthol LOZENGE ORAL 20160420 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 4.8 mg/1 N 20181231 59779-681_60379158-fb34-4515-8ce0-66d1c7b549eb 59779-681 HUMAN OTC DRUG CVS Clear Face SPF 30 3 oz Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 13; 5; 2; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59779-682_b7bbb4ee-e4ce-4ac5-8cac-728751eed984 59779-682 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen SUSPENSION ORAL 20151231 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL N 20181231 59779-683_3c15cad3-cf37-5e8b-e054-00144ff88e88 59779-683 HUMAN OTC DRUG cherry liquid center cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 10 mg/1 N 20181231 59779-684_3c166df3-13e4-0b82-e054-00144ff8d46c 59779-684 HUMAN OTC DRUG honey lemon liquid center cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 10 mg/1 N 20181231 59779-685_ec3d133b-d5a4-4285-a89b-19b4cba44725 59779-685 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20090630 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL N 20181231 59779-686_606f94f8-cbca-4b79-a184-afde760fa023 59779-686 HUMAN OTC DRUG DayTime NightTime Cold/Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCI KIT 20160731 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20191231 59779-687_f506b7cf-2fd4-44ae-ba4b-5d151582a207 59779-687 HUMAN OTC DRUG KIDS EAR RELIEF FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, PYROGENIUM, ARSENICUM ALBUM, BELLADONNA LIQUID ORAL 20140130 UNAPPROVED HOMEOPATHIC CVS PHARMACY FERRUM PHOSPHORICUM; CAPSICUM ANNUUM WHOLE; RANCID BEEF; ARSENIC TRIOXIDE; ATROPA BELLADONNA 30; 30; 30; 30; 30 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 59779-688_a280ea89-2463-4fc9-9d15-b1f4db89b15d 59779-688 HUMAN OTC DRUG CVS Health Non-Drowsy Daytime Cold and Flu Relief Single Serve Cups Daytime Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20160815 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/6g; mg/6g; mg/6g N 20181231 59779-689_c9e48475-a024-4b07-acb6-1ad1a8b3c864 59779-689 HUMAN OTC DRUG Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20160531 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 59779-690_ceda995a-be4b-42d4-afa0-32b5e9bca525 59779-690 HUMAN OTC DRUG CVS Health Non Drowsy Daytime Cold and Flu Relief And Nighttime Cold and Flu Relief Day and Night Twin Pack Acetaminophen ,Dextromethorphan Hydrobromide and Phenylephrine HCl ,Acetaminophen,Dextromethorphan HBR,Doxylamine succinate KIT 20160815 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. N 20181231 59779-694_c371c932-bc17-4dfe-95ad-bb6da9253882 59779-694 HUMAN OTC DRUG CVS Health Nighttime Cold and Flu Relief Single Serve Cups Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate POWDER, FOR SOLUTION ORAL 20160815 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/6g; mg/6g; mg/6g N 20181231 59779-695_3bdd24a8-3b45-00cd-e054-00144ff8d46c 59779-695 HUMAN OTC DRUG sugar free menthol cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 5.8 mg/1 N 20181231 59779-695_3beccea6-8403-61ea-e054-00144ff88e88 59779-695 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 5.8 mg/1 N 20181231 59779-696_3bee513b-6eb7-2133-e054-00144ff88e88 59779-696 HUMAN OTC DRUG sugar free cherry cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 5.8 mg/1 N 20181231 59779-696_3bf01878-1a7b-0b7f-e054-00144ff8d46c 59779-696 HUMAN OTC DRUG sugar free cherry cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 5.8 mg/1 N 20181231 59779-696_3bf10bff-be1a-40e3-e054-00144ff8d46c 59779-696 HUMAN OTC DRUG sugar free cherry cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 5.8 mg/1 N 20181231 59779-697_3c017550-f162-3087-e054-00144ff8d46c 59779-697 HUMAN OTC DRUG sugar free honey lemon cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 7.6 mg/1 N 20181231 59779-697_3c03dbb8-01b5-4f59-e054-00144ff88e88 59779-697 HUMAN OTC DRUG sugar free honey lemon cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 7.6 mg/1 N 20181231 59779-697_3c125b3a-e590-5c06-e054-00144ff88e88 59779-697 HUMAN OTC DRUG sugar free honey lemon cough drops menthol LOZENGE ORAL 20150518 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 7.6 mg/1 N 20181231 59779-697_3c1495eb-09e7-2665-e054-00144ff8d46c 59779-697 HUMAN OTC DRUG sugar free honey lemon cough drops menthol LOZENGE ORAL 20160804 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 7.6 mg/1 N 20181231 59779-698_d85f6e93-6b62-4d00-81a7-7ae7a468d427 59779-698 HUMAN OTC DRUG Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20060824 OTC MONOGRAPH FINAL part341 CVS Pharmacy PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 59779-699_d581d0c8-a359-4870-bf03-5a57b7d0511d 59779-699 HUMAN OTC DRUG stomach relief Bismuth subsalicylate SUSPENSION ORAL 19920624 OTC MONOGRAPH FINAL part335 CVS Pharmacy BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 59779-700_9f5afda1-b112-4d15-9d53-df8d3e8839a4 59779-700 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030224 ANDA ANDA075232 CVS Pharmacy LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 59779-701_515304f7-b849-4c1a-8384-ad48f9199777 59779-701 HUMAN OTC DRUG Infants Gas Relief Original Formula Dimethicone LIQUID ORAL 20130105 OTC MONOGRAPH FINAL part332 CVS DIMETHICONE 20 mg/.3mL E 20171231 59779-703_b64099a7-0890-4d0b-8bbe-8a7da3a1e236 59779-703 HUMAN OTC DRUG 12 Hour Nasal Decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19991201 ANDA ANDA075153 CVS Pharmacy PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 59779-704_c8b9d608-22a8-48f5-a20b-e330317d0c06 59779-704 HUMAN OTC DRUG Infants Gas Relief Non-Staining Formula DIMETHICONE LIQUID ORAL 20130203 OTC MONOGRAPH FINAL part332 CVS DIMETHICONE 20 mg/.3mL E 20171231 59779-705_3d856a31-f674-4b13-b887-bbe96f02199f 59779-705 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140207 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .35 mg/mL N 20181231 59779-706_40991309-fba0-42b1-80ca-bf8cea7785ec 59779-706 HUMAN OTC DRUG Womens Gentle Laxative Bisacodyl TABLET, COATED ORAL 20130401 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy BISACODYL 5 mg/1 N 20181231 59779-707_c7fa8ded-8684-49c6-8b9e-1b05a94c104c 59779-707 HUMAN OTC DRUG arthritis Trolamine Salicylate CREAM TOPICAL 20050610 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy TROLAMINE SALICYLATE 10 g/100g N 20181231 59779-709_752bdeb5-db5b-416e-8dd0-76026ce0471d 59779-709 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150327 ANDA ANDA091135 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 59779-710_1c41a6e6-5554-49b8-b2ca-7fab8d714054 59779-710 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20151007 ANDA ANDA072096 CVS Pharmacy IBUPROFEN 200 mg/1 N 20181231 59779-711_69bb495e-faa6-463b-bbee-5871ae997fc7 59779-711 HUMAN OTC DRUG ARNICA ARNICA MONTANA GEL TOPICAL 20140122 UNAPPROVED HOMEOPATHIC CVS PHARMACY ARNICA MONTANA 1 [hp_X]/g N 20181231 59779-712_48063228-ea13-498c-e054-00144ff88e88 59779-712 HUMAN OTC DRUG CVSHealth Antifungal CLOTRIMAZOLE SOLUTION TOPICAL 20151110 OTC MONOGRAPH FINAL part333C CVS Pharmacy CLOTRIMAZOLE 1 mg/mL N 20181231 59779-713_5b45fde7-ad88-4315-84db-88f27253fbe7 59779-713 HUMAN OTC DRUG CVS ANTI ITCH CAMPHOR, and MENTHOL LOTION RESPIRATORY (INHALATION) 20100708 OTC MONOGRAPH NOT FINAL part348 CVS CAMPHOR (SYNTHETIC); MENTHOL 5; 5 mg/mL; mg/mL E 20171231 59779-717_e3aac781-4648-4350-b0d5-33309d6519cb 59779-717 HUMAN OTC DRUG CAMPHOR, EUCALYPTUS OIL and MENTHOL CAMPHOR, EUCALYPTUS OIL and MENTHOL OINTMENT RESPIRATORY (INHALATION) 20090519 OTC MONOGRAPH NOT FINAL part348 CVS CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 52; 12; 28 mg/mL; mg/mL; mg/mL E 20171231 59779-718_c4180df5-0a76-4cb6-b26a-c89b6aab515c 59779-718 HUMAN OTC DRUG tioconazole 1 Tioconazole OINTMENT VAGINAL 20151112 ANDA ANDA075915 CVS Pharmacy TIOCONAZOLE 6.5 g/100g N 20181231 59779-719_2371023c-6df0-4c6a-bc99-a4e1ff9ad243 59779-719 HUMAN OTC DRUG CVS Pharmacy Maximum Strength Dandruff Selenium Sulfide LIQUID TOPICAL 20170718 OTC MONOGRAPH FINAL part358H CVS Pharmacy SELENIUM SULFIDE 10 mg/mL N 20181231 59779-720_7f008029-0e77-480e-967f-dbd03bf4b74b 59779-720 HUMAN OTC DRUG ANTIBACTERIAL HSOAP FRESH AND LIGHT SCENT - REFILL TRICLOSAN LIQUID TOPICAL 20110318 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .115 L/100L N 20181231 59779-720_ddcc7676-95fa-4a00-b13d-2b337737f88f 59779-720 HUMAN OTC DRUG ANTIBACTERIAL HSOAP FRESH AND LIGHT SCENT - REFILL TRICLOSAN LIQUID TOPICAL 20110203 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN .115 L/100L N 20181231 59779-722_2ab9c1a6-e0c5-1098-e054-00144ff8d46c 59779-722 HUMAN OTC DRUG Scrub Care Exidine-2 CHG CHLORHEXIDINE GLUCONATE SOLUTION TOPICAL 20151201 NDA NDA019422 CVS Pharmacy, Inc. CHLORHEXIDINE GLUCONATE 2 mg/100mL N 20181231 59779-723_a489694d-4e2e-4474-8ae8-c57b94805d1c 59779-723 HUMAN OTC DRUG CVS PHARMACY FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-723_ac349e8c-fc33-4637-90bc-15487e3650d2 59779-723 HUMAN OTC DRUG CVS PHARMACY FRESH WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140507 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-724_550d4ae3-5120-47aa-b769-aa746d35e069 59779-724 HUMAN OTC DRUG CVS PHARMACY CITRUS FRESH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20170126 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-724_5dc0caff-98eb-4964-99dc-4425179ab4a9 59779-724 HUMAN OTC DRUG CVS Pharmacy Citrus Fresh Benzalkonium Chloride LIQUID TOPICAL 20170411 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-724_88fc463f-9817-42ff-a4ad-c89691372875 59779-724 HUMAN OTC DRUG CVS PHARMACY CITRUS FRESH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160119 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-724_a12475dc-010d-49e0-880d-b901988b2ea0 59779-724 HUMAN OTC DRUG CVS PHARMACY CITRUS FRESH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160210 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-725_1ca2c406-0c2d-416e-aada-d48e091ba985 59779-725 HUMAN OTC DRUG CVS PHARMACY CITRUS FRESH BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140113 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-726_143a8778-4029-48d9-82fb-8d70e2a4efe4 59779-726 HUMAN OTC DRUG ALLERGY RELIEF-D Loratadine and Pseudoephedrine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140207 ANDA ANDA076557 CVS Pharmacy LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 59779-727_1473018e-5415-4dd5-853c-1cdd2da77790 59779-727 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20150731 OTC MONOGRAPH FINAL part343 CVS Pharmacy ASPIRIN 81 mg/1 N 20181231 59779-728_26e19c09-6f7d-40fa-a475-8d2d42be0162 59779-728 HUMAN OTC DRUG CVS Pharmacy Quick Relief Zinc Oxide CREAM TOPICAL 20150501 OTC MONOGRAPH FINAL part347 CVS Pharmacy ZINC OXIDE .013 g/g N 20181231 59779-729_62da3593-bd2e-90c1-e053-2991aa0a7b67 59779-729 HUMAN OTC DRUG CVS Cools Itch Fast Hydrocortisone GEL TOPICAL 20141013 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. HYDROCORTISONE 1 mg/g N 20191231 59779-730_2c24d9e5-5da9-40bb-adab-a12097bbec97 59779-730 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20090915 20180331 ANDA ANDA074164 CVS Pharmacy MICONAZOLE NITRATE 20 mg/g N 20181231 59779-731_5ac22bb2-4720-4d6e-a8c9-51878fbdaab8 59779-731 HUMAN OTC DRUG CVS Redness Relief Maximum Dextran 70 Polyethylene glycol 400 Povidone Tetrahydrozoline HCI SOLUTION/ DROPS OPHTHALMIC 20140306 OTC MONOGRAPH FINAL part349 CVS Pharmacy, Inc. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE .001; .01; .01; .0005 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 59779-732_186732a3-13b9-4ea2-ba54-424f63298a2e 59779-732 HUMAN OTC DRUG Omeprazole and Sodium Bicarbonate Omeprazole, sodium bicarbonate CAPSULE, GELATIN COATED ORAL 20160715 ANDA ANDA201361 CVS Pharmacy OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 N 20181231 59779-733_7e3f870b-180b-483a-97ff-3bb86ba6e051 59779-733 HUMAN OTC DRUG aspirin Aspirin TABLET ORAL 20150810 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 325 mg/1 N 20181231 59779-734_f4a646a8-c2a2-418b-8057-16515ec3e6f0 59779-734 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130213 ANDA ANDA203690 CVS Pharmacy NICOTINE 2 mg/1 N 20181231 59779-735_4db1b179-6525-4045-ad18-4784c11cfbe3 59779-735 HUMAN OTC DRUG Mucus DM Extended Release Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160428 ANDA ANDA091070 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 59779-737_6683b2fa-c12d-4199-b0b1-9fca6505a123 59779-737 HUMAN OTC DRUG Miconazole 1 Miconazole nitrate KIT 20100608 ANDA ANDA079114 CVS Pharmacy N 20181231 59779-738_0d724fa8-e431-417d-bb8b-8d621a340042 59779-738 HUMAN OTC DRUG Acid Reducer Plus Antacid famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160211 ANDA ANDA077355 CVS Pharmacy FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 59779-739_c93d9aaa-0b2c-4c88-b30d-6c3c7178abba 59779-739 HUMAN OTC DRUG Cold Relief Multi Symptom Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 59779-740_3c564bad-731f-627c-e054-00144ff88e88 59779-740 HUMAN OTC DRUG cherry antacid soft chew calcium carbonate TABLET, CHEWABLE ORAL 20150518 OTC MONOGRAPH FINAL part331 CVS Pharmacy CALCIUM CARBONATE 1177 mg/1 N 20181231 59779-741_5eff2416-8906-bc38-e053-2991aa0a0617 59779-741 HUMAN OTC DRUG CVS Redness Relief Original Tetrahydrozoline hydrochloride SOLUTION/ DROPS OPHTHALMIC 20140306 OTC MONOGRAPH FINAL part349 CVS Pharmacy, Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 59779-743_4a873d9c-3e90-49d4-934a-1cebb77e7800 59779-743 HUMAN OTC DRUG CVS Pharmacy Maximum Strength Benzocaine LIQUID DENTAL 20150101 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g N 20181231 59779-744_6f7ded3a-2cde-4b27-aa28-b33777dcdbb9 59779-744 HUMAN OTC DRUG CVS PHARMACY HAND SANITIZER ALOE ETHYL ALCOHOL LIQUID TOPICAL 20141117 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL N 20181231 59779-744_e4657641-e67d-48df-a3f5-b0ce79553f23 59779-744 HUMAN OTC DRUG CVS PHARMACY HAND SANITIZER ALOE ETHYL ALCOHOL LIQUID TOPICAL 20141117 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY ALCOHOL 650 mg/mL N 20181231 59779-745_a81636e7-beb6-4133-b7f3-6a29861c99cc 59779-745 HUMAN OTC DRUG CVS SPORT SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20150721 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTOCRYLENE 1.8; 7; 5 g/100g; g/100g; g/100g N 20181231 59779-746_7af08584-761e-4663-bda2-8db3d9c55d8f 59779-746 HUMAN OTC DRUG Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20160410 ANDA ANDA078104 CVS Pharmacy TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 59779-747_e9ee6ca6-888b-46cd-9134-feeb51f4af4b 59779-747 HUMAN OTC DRUG CVS Health Medicated WITCH HAZEL CLOTH TOPICAL 20151124 OTC MONOGRAPH FINAL part346 CVS Pharmacy WITCH HAZEL 500 mg/1 N 20181231 59779-748_3c6551e9-6f30-6fd0-e054-00144ff8d46c 59779-748 HUMAN OTC DRUG Assorted Fruit Antacid Flavor Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20150601 OTC MONOGRAPH FINAL part331 CVS Pharmacy CALCIUM CARBONATE 750 mg/1 N 20181231 59779-748_3c679059-2533-485a-e054-00144ff88e88 59779-748 HUMAN OTC DRUG Assorted Fruit Antacid Flavor Chews calcium carbonate TABLET, CHEWABLE ORAL 20150601 OTC MONOGRAPH FINAL part331 CVS Pharmacy CALCIUM CARBONATE 750 mg/1 N 20181231 59779-748_3c683783-87ab-1a6e-e054-00144ff8d46c 59779-748 HUMAN OTC DRUG Assorted Fruit Antacid Flavor Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20150601 OTC MONOGRAPH FINAL part331 CVS Pharmacy CALCIUM CARBONATE 750 mg/1 N 20181231 59779-749_282556ca-869d-4a0b-b99f-d2a4c7304148 59779-749 HUMAN OTC DRUG Beauty 360 Daily Moisturizing Dimethicone LOTION TOPICAL 20170202 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 12 mg/mL N 20191231 59779-749_7d54967a-95eb-4a10-bc76-f53b03f0ba84 59779-749 HUMAN OTC DRUG Beauty 360 Daily Moisturizing Dimethicone LOTION TOPICAL 20180108 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 12 mg/mL N 20191231 59779-749_9415628d-4dbd-4adb-a27a-28a68473010f 59779-749 HUMAN OTC DRUG Beauty 360 Daily Moisturizing Dimethicone LOTION TOPICAL 20170112 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 12 mg/mL N 20191231 59779-749_d7f0d6d6-dda4-4b82-9958-06630fa5fda6 59779-749 HUMAN OTC DRUG Beauty 360 Daily Moisturizing Dimethicone LOTION TOPICAL 20170227 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 12 mg/mL N 20191231 59779-750_358e7424-21a9-4272-92ae-780947d4b880 59779-750 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, POWDER TOPICAL 20140104 OTC MONOGRAPH FINAL part333C CVS Pharmacy TOLNAFTATE 1.3 g/130g N 20181231 59779-751_877e17fd-801b-4969-a444-a3f7ef325dbe 59779-751 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 N 20181231 59779-752_74652de5-c461-4f70-bcb7-1dc84c77479c 59779-752 HUMAN OTC DRUG CVS Hemorrhoidal Glycerin Phenylephrine HCI Pramoxine HCI White Petrolatum CREAM TOPICAL 20140117 OTC MONOGRAPH FINAL part346 CVS Pharmacy, Inc. GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 59779-753_82d23e12-7bbe-448a-a349-460b33915ee5 59779-753 HUMAN OTC DRUG CVS Sport AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20151019 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3; 10; 6 g/100g; g/100g; g/100g N 20181231 59779-754_9fe6d503-4cca-4703-b209-29f7bb0e2d57 59779-754 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 20090715 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL N 20181231 59779-755_5eff2416-8908-bc38-e053-2991aa0a0617 59779-755 HUMAN OTC DRUG CVS Lubricant Eye Sodium Carboxymethylcellulose SOLUTION/ DROPS OPHTHALMIC 20160304 OTC MONOGRAPH FINAL part349 CVS Pharmacy CARBOXYMETHYLCELLULOSE SODIUM 2.5 mg/mL N 20181231 59779-756_5fdd580d-17b6-6599-e053-2a91aa0a7a82 59779-756 HUMAN OTC DRUG CVS Health Isopropyl Rubbing Alcohol Isopropyl Alcohol CLOTH TOPICAL 20170119 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy ISOPROPYL ALCOHOL .7 g/g N 20181231 59779-757_1793c42d-e615-4d7e-b5da-cfd8fb86a91a 59779-757 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20150831 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 N 20181231 59779-758_3368b1b1-bc0e-422d-ac13-c5c100097ecf 59779-758 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140204 ANDA ANDA091292 CVS Pharmacy LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 59779-760_66329d78-eacc-4565-ad65-babe7a42623d 59779-760 HUMAN OTC DRUG severe cough and cold Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20100914 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 59779-761_61c10acd-5b2f-44a6-9106-2f969fb205f5 59779-761 HUMAN OTC DRUG Severe Congestion and Cold Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 59779-762_13c64f1e-fc94-4aff-83ed-8a4c2f0cfbee 59779-762 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20151031 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 59779-763_72267792-873a-42ef-a615-1fa6b3edfb9b 59779-763 HUMAN OTC DRUG Severe Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20131227 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 59779-764_bd8f5171-5493-45a5-b021-6190716995cd 59779-764 HUMAN OTC DRUG CVS Health Maximum Strength Sore Throat Fast Relief Phenol and Glycerin SPRAY ORAL 20150518 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy,Inc. PHENOL; GLYCERIN 15; 330 mg/mL; mg/mL N 20181231 59779-765_b36c55f9-c0f4-4fa6-83a1-4fd2d18b2661 59779-765 HUMAN OTC DRUG Witch Hazel Witch Hazel Spray SPRAY TOPICAL 20170301 OTC MONOGRAPH FINAL part347 CVS Pharmacy WITCH HAZEL 146 g/170g N 20181231 59779-766_94c6ba02-9060-455a-b191-19a5359a0068 59779-766 HUMAN OTC DRUG pain relief Acetaminophen TABLET ORAL 19910615 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 325 mg/1 N 20181231 59779-767_481aae48-f177-02aa-e054-00144ff8d46c 59779-767 HUMAN OTC DRUG Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 4% LIQUID TOPICAL 20110831 NDA NDA019125 CVS Pharmacy, Inc. CHLORHEXIDINE GLUCONATE 4 g/100mL N 20181231 59779-768_8b9ef482-2c07-4982-95be-8e8237e71c13 59779-768 HUMAN OTC DRUG Multi Symptom Severe Cold and Nighttime Severe Cold and Cough Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl KIT 20150921 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. N 20181231 59779-769_9227dbb4-56c1-453f-b012-de16f5836879 59779-769 HUMAN OTC DRUG Lice Treatment Permethrin LOTION TOPICAL 20160503 ANDA ANDA076090 CVS Pharmacy PERMETHRIN 1 mg/100mL N 20181231 59779-770_c34dee09-f23a-46bf-8b7a-68c22103aaaa 59779-770 HUMAN OTC DRUG CVS Medicated Heat 1 ct Capsaicin PATCH TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. CAPSAICIN .025 g/g N 20181231 59779-771_8a254b57-d7ce-4a0c-8748-a9e6574c7e88 59779-771 HUMAN OTC DRUG CVS Health Extra Strength Sinus Relief Nasal Decongestant Phenylephrine Hydrochloride SPRAY NASAL 20150818 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 59779-772_e0a0ff31-81ed-4c55-b9d6-543b3aae36d9 59779-772 HUMAN OTC DRUG aspirin Aspirin TABLET ORAL 20151014 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 325 mg/1 N 20181231 59779-773_2226c396-9099-4404-aff1-f56f7aefafb6 59779-773 HUMAN OTC DRUG Miconazole 3 Combination Pack Miconazole Nitrate KIT 20010301 ANDA ANDA074926 CVS Pharmacy N 20181231 59779-774_62dadf6f-ac4c-427f-e053-2a91aa0ab9e2 59779-774 HUMAN OTC DRUG CVS Health Maxium Strentgh Cortisone Hydrocortisone LOTION TOPICAL 20160425 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 mg/mL N 20191231 59779-775_80c06b9a-fe00-4955-9733-5dfb56046e51 59779-775 HUMAN OTC DRUG Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20151203 ANDA ANDA090254 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 59779-776_d867ac27-05bd-4076-9161-aadaf07b85ab 59779-776 HUMAN OTC DRUG CVS Daytime Severe Cough and Cold ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE POWDER, FOR SOLUTION ORAL 20151022 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 59779-777_46643cbb-edd8-1292-e054-00144ff8d46c 59779-777 HUMAN OTC DRUG NUANCE Salma Hayek Renewed Radiance Moisturizing Day Cream Broad Spectrum SPF 30 Sunscreen NUANCE Salma Hayek Renewed Radiance Moisturizing Day Cream Broad Spectrum SPF 30 Sunscreen LOTION TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy, Inc AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100g; g/100g; g/100g N 20181231 59779-778_32961d50-b9f2-4e71-a655-9a2b384b29da 59779-778 HUMAN OTC DRUG CVS Health Prebiotic Sanitizer Ethyl Alcohol LIQUID TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy ALCOHOL 650 mg/mL N 20191231 59779-778_d967044a-4919-49d4-9ef2-ed5aff75083b 59779-778 HUMAN OTC DRUG CVS Health Prebiotic Sanitizer Ethyl Alcohol LIQUID TOPICAL 20170221 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy ALCOHOL 650 mg/mL N 20191231 59779-779_acb486e8-bb6f-41cd-808f-08b196ef38db 59779-779 HUMAN OTC DRUG SINUS PAIN AND CONGESTION Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl KIT 20050726 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-780_faefef09-b927-4d6e-95de-6f55da7aa587 59779-780 HUMAN OTC DRUG CVS Health Medicated Lip Care Avobenzone, Dimethicone, Octinoxate, Octisalate STICK TOPICAL 20150901 OTC MONOGRAPH FINAL part352 CVS Pharmacy AVOBENZONE; DIMETHICONE; OCTINOXATE; OCTISALATE 30; 10; 75; 50 mg/g; mg/g; mg/g; mg/g N 20181231 59779-782_6219761f-0fa7-436c-85f1-2adb25956ceb 59779-782 HUMAN OTC DRUG CVS Health Lip Moisture Mint octinoxate, oxybenzone, white petrolatum STICK TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 407 mg/g; mg/g; mg/g N 20181231 59779-783_590c2220-fbca-4709-9adc-c519b515a496 59779-783 HUMAN OTC DRUG CVS Health Lip Moisture Cherry octinoxate, oxybenzone, white petrolatum STICK TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; OXYBENZONE; PETROLATUM 75; 35; 407 mg/g; mg/g; mg/g N 20181231 59779-784_805c79a4-bba9-44f2-b52d-4aa67f83dd37 59779-784 HUMAN OTC DRUG CVS Health Lip Repair dimethicone, octinoxate, octisalate, oxybenzone STICK TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g N 20181231 59779-785_519565e0-0bff-4497-a9cf-3b4f3d295fa5 59779-785 HUMAN OTC DRUG Pain and Fever Childrens Acetaminophen SUSPENSION ORAL 20150831 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL N 20181231 59779-786_d9e91105-175c-449b-99b3-54df7c539f8f 59779-786 HUMAN OTC DRUG CVS Health Nasal Mist oxymetazoline hydrochloride SPRAY NASAL 20150825 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 59779-787_3e15a1f9-c93e-4cdb-865c-68bfa63d3323 59779-787 HUMAN OTC DRUG CVS Health Sinus Relief oxymetazoline hydrochloride SPRAY NASAL 20150421 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. OXYMETAZOLINE HYDROCHLORIDE .0005 g/mL N 20181231 59779-788_5eff2416-8917-bc38-e053-2991aa0a0617 59779-788 HUMAN OTC DRUG CVS Nighttime Dry-Eye Relief Mineral oil, and White petrolatum OINTMENT OPHTHALMIC 20160930 OTC MONOGRAPH FINAL part349 CVS Pharmacy, Inc. MINERAL OIL; PETROLATUM 425; 573 mg/g; mg/g N 20181231 59779-789_0371291b-345d-45e0-95e9-4bb56f2681fa 59779-789 HUMAN OTC DRUG Itch Relief Extra Strength Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20160506 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g N 20181231 59779-790_bf73d15a-9d68-42fa-bfee-d25748215f97 59779-790 HUMAN OTC DRUG CVS Health Medicated Chest Rub camphor, eucalyptus oil, menthol OINTMENT TOPICAL 20150901 OTC MONOGRAPH FINAL part341 CVS Pharmacy CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL, UNSPECIFIED FORM 48; 12; 26 mg/g; mg/g; mg/g N 20181231 59779-791_1ca1a631-cb2c-46cd-bd41-05469b08d208 59779-791 HUMAN OTC DRUG CVS Health Cold and Hot Pain Relieving Extra Strength menthol, methyl salicylate CREAM TOPICAL 20161003 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 100; 300 mg/g; mg/g N 20181231 59779-792_4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a 59779-792 HUMAN OTC DRUG CVS Health Muscle Rub Ultra Strength camphor, menthol, methyl salicylate CREAM TOPICAL 20161003 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g N 20181231 59779-793_1ccf7ffb-3b53-48a4-acc6-e52f249fcc05 59779-793 HUMAN OTC DRUG CVS Health Childrens Allergy Relief Diphenhydramine hydrochloride LIQUID ORAL 20150907 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 59779-794_c4105eb2-9126-4eb1-9722-59baa8fd035b 59779-794 HUMAN OTC DRUG CHILDRENS ALLERGY RELIEF Fexofenadine Hydrochloride SUSPENSION ORAL 20141219 ANDA ANDA203330 CVS Pharmacy FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 59779-795_0c9c5902-18c5-4053-a72a-7994da7ae5ab 59779-795 HUMAN OTC DRUG CVS Health Natural Daily Fiber Natural Fiber Psyllium Husk POWDER ORAL 20150825 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy,Inc. PSYLLIUM HUSK 3.4 g/7.2g N 20181231 59779-796_bef4f237-ccb8-4d28-bfc2-41c511a17d7f 59779-796 HUMAN OTC DRUG No Drip Nasal Mist Original oxymetazoline hydrochloride SPRAY NASAL 20120901 OTC MONOGRAPH FINAL part341 CVS Pharmacy OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 59779-797_92b42c74-9ac0-4e34-b105-8262c995f0bd 59779-797 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20160105 ANDA ANDA074661 CVS Pharmacy NAPROXEN SODIUM 200 mg/1 N 20181231 59779-798_d54adf61-f5aa-4444-8533-513f6ca4af2a 59779-798 HUMAN OTC DRUG Hair regrowth treatment for men Minoxidil SOLUTION TOPICAL 20100105 ANDA ANDA075598 CVS Pharmacy MINOXIDIL 3 g/60mL N 20181231 59779-799_7984e5e8-33f6-4ea1-9937-5a85320c2221 59779-799 HUMAN OTC DRUG Non Drowsy Cold and Cough PE Acetaminophen, Dextromathorphan HBr, Gauifenesin, Phenylephrine HCl CAPSULE, COATED ORAL 20070222 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 59779-800_2e8c6a1a-06e1-4c8b-ac88-f30051f65ef2 59779-800 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20130725 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 59779-801_3e903155-ab86-439a-8c32-9d44238c9e2c 59779-801 HUMAN OTC DRUG CVS PHARMACY TRICLOSAN LIQUID TOPICAL 20130404 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY TRICLOSAN 1.5 mg/mL N 20181231 59779-802_a682d6b6-33e3-4b66-bc24-7ea73753f2fd 59779-802 HUMAN OTC DRUG Sinus PE Pressure plus Pain MAXIMUM STRENGTH Acetaminophen, Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 59779-804_49dd5e24-f9b9-48db-9c19-964ced1a6575 59779-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 19920715 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ISOPROPYL ALCOHOL .91 mg/mL N 20181231 59779-805_9b5ba347-49e9-42c1-8f83-d171cb1b6f6d 59779-805 HUMAN OTC DRUG Antibacterial Body Wash Triclosan LIQUID TOPICAL 20110627 OTC MONOGRAPH NOT FINAL part333E CVS Pharmacy TRICLOSAN .15 mL/100mL N 20181231 59779-806_ed2229b7-5bcf-49e2-8be9-ae7299139371 59779-806 HUMAN OTC DRUG VIPER ACNE BODY WASH SALICYLIC ACID LIQUID TOPICAL 20110318 OTC MONOGRAPH FINAL part333D CVS PHARMACY SALICYLIC ACID 2 mL/100mL N 20181231 59779-807_48732d5b-70ac-41cd-86b4-ea45d7ec9c54 59779-807 HUMAN OTC DRUG CVS Triple Action Astringent SALICYLIC ACID LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 20.5 mg/mL E 20171231 59779-807_ba9d81bd-e62c-4863-a424-33f26e96319d 59779-807 HUMAN OTC DRUG CVS Triple Action Astringent SALICYLIC ACID LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 20.5 mg/mL E 20171231 59779-808_5dfd80ed-b2d1-4a16-a11c-a72bde930168 59779-808 HUMAN OTC DRUG CVS Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 59779-810_fa434f3c-a4ea-4745-8206-abaeff14054d 59779-810 HUMAN OTC DRUG BENZOCAINE and RESORCINOL BENZOCAINE and RESORCINOL CREAM TOPICAL 20090519 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy BENZOCAINE; RESORCINOL 200; 20 mg/g; mg/g N 20181231 59779-811_c1066802-f7b3-4ed4-8669-7ce60d90838a 59779-811 HUMAN OTC DRUG CVS Deep Cleansing Astringent SALICYLIC ACID LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 5 mg/mL E 20171231 59779-812_3564ecc2-9d0b-45a3-8840-811950047255 59779-812 HUMAN OTC DRUG CVS Pore Unclogging Scrub SALICYLIC ACID SOAP TOPICAL 20100708 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 20 mg/g E 20171231 59779-813_309dfa96-35c0-4c59-ae92-ba543c3dd666 59779-813 HUMAN OTC DRUG CVS ACNE TREATMENT RESORCINOL, SULFUR CREAM TOPICAL 20100710 OTC MONOGRAPH NOT FINAL part333D CVS Pharmacy RESORCINOL; SULFUR 20; 80 mg/g; mg/g E 20171231 59779-814_4ba4ccf6-fc46-4053-a060-fe18b5fbe228 59779-814 HUMAN OTC DRUG Sensitive Whitening Enamel Guard Fluoride and Potassium Nitrate GEL DENTAL 20111213 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy POTASSIUM NITRATE; SODIUM FLUORIDE 5; .15 g/100g; g/100g N 20181231 59779-815_dcd32a69-20e3-4016-ba99-50ed18b15de5 59779-815 HUMAN OTC DRUG CVS Pharmacy Enamel Guard Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 CVS Pharmacy SODIUM FLUORIDE; POTASSIUM NITRITE .15; 5 g/100g; g/100g N 20181231 59779-816_247bcabe-a146-4a58-9251-7ee703dceb27 59779-816 HUMAN OTC DRUG Sensitive Tooth Paste Whitening Fluoride GEL DENTAL 20111213 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy POTASSIUM NITRATE; SODIUM FLUORIDE 5; .15 g/100g; g/100g N 20181231 59779-817_79300708-9b98-45c1-a78e-22f49a3cea48 59779-817 HUMAN OTC DRUG nasal sinus oxymetazoline hydrochloride SPRAY NASAL 19991005 OTC MONOGRAPH FINAL part341 CVS Pharmacy OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 59779-818_e58a4bfe-2c71-4655-b026-08b9dfe724ee 59779-818 HUMAN OTC DRUG CVS Scalp Relief Salicylic Acid LIQUID TOPICAL 20140601 OTC MONOGRAPH FINAL part358H CVS Pharmacy SALICYLIC ACID 3 g/100mL N 20181231 59779-819_1029facf-4f3e-4089-b384-0edcccbefb71 59779-819 HUMAN OTC DRUG Sensitive Tooth Paste Multi Action Fluoride GEL DENTAL 20111213 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy POTASSIUM NITRATE; SODIUM FLUORIDE 5; .15 g/100g; g/100g N 20181231 59779-820_f3d0f9e6-fa23-4944-aef0-43dfcacfc1b0 59779-820 HUMAN OTC DRUG Severe Oral Pain Reliever Benzocaine LIQUID ORAL 20111227 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g N 20181231 59779-821_654e7ef3-27f3-42d5-831e-e88d32996368 59779-821 HUMAN OTC DRUG CVS Cold Hot Medicated Menthol PATCH TOPICAL 20131014 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy Inc. MENTHOL .05 g/g E 20171231 59779-822_73c077e0-8173-4f8e-9c60-c294b0cf5c01 59779-822 HUMAN OTC DRUG Antibiotic and Pain Relief Maximum Strength Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part347 CVS Pharmacy NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g N 20181231 59779-823_fbad807b-c62d-4066-91c8-3509f6317d93 59779-823 HUMAN OTC DRUG Triple Antibiotic and Pain Relief Maximum Strength bacitracin zinc, neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride OINTMENT TOPICAL 20050103 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 59779-824_edffef0f-49cc-44f2-bcc2-c0d9ef3386d5 59779-824 HUMAN OTC DRUG Tension Headache Aspirin Free Acetaminophen, Caffeine TABLET ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 59779-825_379fa927-0ed7-497e-a544-4cd4f0d4f98a 59779-825 HUMAN OTC DRUG Mucus D Guaifenesin, pseudoephedrine hydrochloride TABLET ORAL 20151218 ANDA ANDA091071 CVS Pharmacy GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 59779-826_779648c8-ab59-4dd6-b317-b5f69e6657ff 59779-826 HUMAN OTC DRUG Therapeutic Plus Coal Tar SHAMPOO TOPICAL 20020524 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc COAL TAR 25 mg/mL N 20181231 59779-827_a40da787-5a56-4ae5-8a62-f2091a89a38f 59779-827 HUMAN OTC DRUG Diaper Rash Dimethicone, Zinc Oxide CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE; ZINC OXIDE 1; 10 g/100g; g/100g N 20181231 59779-828_b15a4a04-6588-41dc-8c76-986d6198f929 59779-828 HUMAN OTC DRUG congestion relief Ibuprofen, phenylephrine HCl TABLET, FILM COATED ORAL 20140919 ANDA ANDA203200 CVS Pharmacy IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20181231 59779-829_4b601522-3099-4501-90aa-093c4645c25a 59779-829 HUMAN OTC DRUG CVS Fast Acting Baby Teething BENZOCAINE GEL ORAL 20100708 OTC MONOGRAPH FINAL part346 CVS Pharmacy BENZOCAINE 75 mg/g E 20171231 59779-829_e0ba65c6-5dc4-4b1c-95f4-a3b815fc5c14 59779-829 HUMAN OTC DRUG CVS Fast Acting Baby Teething BENZOCAINE GEL ORAL 20100708 OTC MONOGRAPH FINAL part346 CVS Pharmacy BENZOCAINE 75 mg/g E 20171231 59779-830_b8178aba-50dd-4fbb-8352-bdb6ea2980ef 59779-830 HUMAN OTC DRUG Mouth Sore Relief Professional Strength Benzocaine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 200 mg/g N 20181231 59779-831_f259b98b-c4bc-4ba9-bbbf-131ce491b81b 59779-831 HUMAN OTC DRUG Instant Toothache Pain Relief Benzocaine LIQUID ORAL 20091001 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g N 20181231 59779-832_f5b5ac73-4a30-467f-b208-76f4dad9a6af 59779-832 HUMAN OTC DRUG CVS Pharmacy Restore and Defend Fluoride PASTE, DENTIFRICE DENTAL 20140701 OTC MONOGRAPH FINAL part355 CVS Pharmacy STANNOUS FLUORIDE .15 g/100g N 20181231 59779-833_1eaadd8b-b6c6-4625-858c-6304265fcdee 59779-833 HUMAN OTC DRUG CVS Pharmacy Nighttime Oral Pain Relief Benzocaine GEL, DENTIFRICE DENTAL 20130801 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 10 g/100g N 20181231 59779-834_01a56b38-8773-420d-aaff-222781074440 59779-834 HUMAN OTC DRUG Daily Face Wash CVS Salicylic Acid CREAM TOPICAL 20160915 OTC MONOGRAPH FINAL part333D CVS SALICYLIC ACID 2 g/100mL N 20181231 59779-835_c3e5ee58-0453-4842-a372-ae95d4823618 59779-835 HUMAN OTC DRUG Anti-Fungal Pen CVS Undecylenic Acid LIQUID TOPICAL 20160915 OTC MONOGRAPH FINAL part333C CVS UNDECYLENIC ACID 25 g/100mL N 20181231 59779-836_4c4ef312-0197-46a9-9cd7-210903442c24 59779-836 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20131206 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc PYRITHIONE ZINC 10.3 mg/mL N 20181231 59779-837_b14fb748-b688-465c-a36e-415e94eff9d2 59779-837 HUMAN OTC DRUG allergy relief childrens Cetirizine HCl SOLUTION ORAL 20150911 ANDA ANDA204226 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 59779-838_c91b5525-6afb-4fea-afcb-9c4578075975 59779-838 HUMAN OTC DRUG CVS Health Four Actions Nasal Decongestant Phenylephrine hydrochloride SPRAY NASAL 20150401 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL N 20181231 59779-839_21370d8d-9ef6-48b3-8476-a2192a7fd581 59779-839 HUMAN OTC DRUG Miconazole 3 Miconazole nitrate KIT 20140228 ANDA ANDA076357 CVS Pharmacy N 20181231 59779-840_f970dadf-5c83-4857-bd03-e4427ff26600 59779-840 HUMAN OTC DRUG CVS Extra Whitening Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 59779-841_df371107-50c0-4c33-b8e0-c5c731ecd794 59779-841 HUMAN OTC DRUG Multi-Purpose Skin Protectant A and D Ointment OINTMENT TOPICAL 20160720 OTC MONOGRAPH FINAL part347 CVS Pharmacy PETROLATUM; LANOLIN 53.4; 15.5 g/100g; g/100g N 20181231 59779-842_36a44418-1c8d-4b42-a176-2b374fdc9000 59779-842 HUMAN OTC DRUG CVS PHARMACY COCONUT WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140126 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-842_a63c4b93-ec1d-4a2b-9c5a-6b858a042b02 59779-842 HUMAN OTC DRUG CVS PHARMACY COCONUT WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-842_e6e0aa6a-56cb-4cb1-a59e-df1fef8f7c55 59779-842 HUMAN OTC DRUG CVS PHARMACY COCONUT WATER BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160209 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-843_2f126a5c-5a5b-4458-b040-b8c80acf8d0e 59779-843 HUMAN OTC DRUG cooling hemorrhoidal Phenylephrine HCl, Witch hazel GEL TOPICAL 20050609 OTC MONOGRAPH FINAL part346 CVS Pharmacy PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL .25; 50 g/100g; g/100g N 20181231 59779-844_334541c6-8d1a-4f41-b228-dba2ec18b203 59779-844 HUMAN OTC DRUG CVS Anti-Itch Hydrocortisone Hydrocortisone CREAM TOPICAL 20140225 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. HYDROCORTISONE 1 mg/g N 20181231 59779-845_9456cfec-f832-436d-986b-eff89c5ed003 59779-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20150626 OTC MONOGRAPH FINAL part344 CVS Pharmacy, Inc ISOPROPYL ALCOHOL 613 mg/mL N 20181231 59779-846_8d2c838d-23ec-4429-8311-f4d71ea8f9d3 59779-846 HUMAN OTC DRUG DIARRHEA CINCHONA OFFICINALIS, BRYONIA, CHAMOMILLA, COLOCYNTHIS, IPECACUANHA, BELLADONNA TABLET, CHEWABLE ORAL 20140429 UNAPPROVED HOMEOPATHIC CVS PHARMACY CINCHONA OFFICINALIS BARK; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; ATROPA BELLADONNA 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59779-847_ec082769-c688-4aca-9685-5c521a0a5856 59779-847 HUMAN OTC DRUG INDIGESTION LYCOPODIUM CLAVATUM, CARDUUS MARIANUS, CHELIDONIUM MAJUS, BOLDO, NUX VOMICA TABLET, CHEWABLE ORAL 20140522 UNAPPROVED HOMEOPATHIC CVS PHARMACY LYCOPODIUM CLAVATUM SPORE; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; PEUMUS BOLDUS LEAF; STRYCHNOS NUX-VOMICA SEED 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59779-848_5c60191b-c72e-496b-89c7-eff398615b45 59779-848 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET ORAL 20151210 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 59779-849_703805b2-1298-4783-a5b3-c17b7858c0e3 59779-849 HUMAN OTC DRUG Maximum Strength Diaper Rash Zinc Oxide Ointment OINTMENT TOPICAL 20160722 OTC MONOGRAPH FINAL part347 CVS Pharmacy ZINC OXIDE 40 g/100g N 20181231 59779-850_5f702ed1-b648-4cb7-8773-efd08d70e3dd 59779-850 HUMAN OTC DRUG Therapeutic Coal Tar SHAMPOO TOPICAL 20160315 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc. COAL TAR 1.02 mg/mL N 20181231 59779-851_cb0b1221-fd0a-40e1-8e5a-d728382a72d9 59779-851 HUMAN OTC DRUG antacid regular strength Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20021209 OTC MONOGRAPH FINAL part332 CVS Pharmacy ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 59779-852_0526a1a5-c71f-4efd-890e-c95f47e67160 59779-852 HUMAN OTC DRUG Stool Softener Extra Strength DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20141130 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 250 mg/1 N 20181231 59779-853_192328ff-3c85-4f5a-be0d-faad1ac0ad5a 59779-853 HUMAN OTC DRUG Hydrating Healing Skin Protectant Petrolatum Ointment OINTMENT TOPICAL 20160725 OTC MONOGRAPH FINAL part347 CVS Pharmacy PETROLATUM 41 g/100g N 20181231 59779-853_dc0507f5-8a7e-46df-8a19-270e35eb3374 59779-853 HUMAN OTC DRUG Hydrating Healing Skin Protectant Petrolatum Ointment OINTMENT TOPICAL 20170806 OTC MONOGRAPH FINAL part347 CVS Pharmacy PETROLATUM 41 g/100g N 20181231 59779-854_6779b5f0-6d05-4c99-b72c-2e3063d12988 59779-854 HUMAN OTC DRUG nicotine Nicotine polacrilex GUM, CHEWING ORAL 20070915 ANDA ANDA078546 CVS Pharmacy NICOTINE 4 mg/1 N 20181231 59779-855_53036f2b-f352-45fd-9fe0-5bce7de4e63d 59779-855 HUMAN OTC DRUG Tartar control Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130105 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 59779-857_ff812bb6-e48b-46bc-9477-f8b691198a3a 59779-857 HUMAN OTC DRUG Constipation Relief Alumina, Bryonia, Graphites, Natrum Muriaticum, Silicea LIQUID ORAL 20141030 UNAPPROVED HOMEOPATHIC WOONSOCKET PRESCR CTR INC ALUMINUM OXIDE; BRYONIA ALBA ROOT; GRAPHITE; SODIUM CHLORIDE; SILICON DIOXIDE 8; 8; 8; 8; 8 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 59779-858_06f026c2-80db-4716-8420-670933b0c8b3 59779-858 HUMAN OTC DRUG Gallbladder Relief Belladonna, Carduus Marianus, Chelidonium Majus, Colocynthis, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vornica, Phosphorus, Pulsatilla, Veratrum Album TABLET ORAL 20141111 UNAPPROVED HOMEOPATHIC WOONSOCKET PRESCR CTR INC ATROPA BELLADONNA; MILK THISTLE; CHELIDONIUM MAJUS; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601; [hp_X]/601 N 20181231 59779-860_fb2fef3e-1ef9-46e2-a83a-c043a625405c 59779-860 HUMAN OTC DRUG INFANTS TEETHING CHAMOMILLA, CALCAREA PHOSPHORICA, COFFEA CRUDA, BELLADONNA TABLET, ORALLY DISINTEGRATING ORAL 20140214 UNAPPROVED HOMEOPATHIC CVS PHARMACY CHAMOMILE; CALCIUM PHOSPHATE; COFFEA ARABICA FRUIT; ATROPA BELLADONNA WHOLE 6; 6; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59779-861_ee1fa970-78c3-47c4-93d1-05bcafce621b 59779-861 HUMAN OTC DRUG Oil Free Moisturizer Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20160225 OTC MONOGRAPH FINAL part352 CVS Pharmacy OCTINOXATE; OCTISALATE; AVOBENZONE 76.5; 51; 30.6 mg/mL; mg/mL; mg/mL N 20181231 59779-862_b3a8bdd1-c18d-45fa-9caf-3028180ae503 59779-862 HUMAN OTC DRUG Acid Reducer Plus Antacid Famotidine, Calcium Carbonate, Magnesium Hydroxide TABLET, CHEWABLE ORAL 20160211 ANDA ANDA077355 CVS Pharmacy FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 10; 800; 165 mg/1; mg/1; mg/1 N 20181231 59779-863_64180023-8bc4-4de7-bd77-2d2320f68790 59779-863 HUMAN OTC DRUG Nighttime Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 CVS Pharmacy DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 59779-864_4cd4fc86-8827-4193-b93b-7b94f2178f2d 59779-864 HUMAN OTC DRUG CVS Sodium Chloride, Sodium Bicarbonate KIT 20160325 UNAPPROVED DRUG OTHER CVS Pharmacy N 20181231 59779-865_4a47718a-de94-47ef-96a8-f115ee8ca168 59779-865 HUMAN OTC DRUG CVS SODIUM BICARBONATE, SODIUM CHLORIDE SOLUTION NASAL 20160301 UNAPPROVED DRUG OTHER CVS Pharmacy SODIUM BICARBONATE; SODIUM CHLORIDE 22.2; 77.8 mg/.1g; mg/.1g N 20181231 59779-866_bd7f2daf-23e3-4209-bdd7-89782306f269 59779-866 HUMAN OTC DRUG lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20070713 OTC MONOGRAPH NOT FINAL part358G CVS Pharmacy PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL N 20181231 59779-867_42f0b413-e961-475a-86b4-829ac7dd5f91 59779-867 HUMAN OTC DRUG CVS Sodium Chloride, Sodium Bicarbonate KIT 20150701 UNAPPROVED DRUG OTHER CVS Pharmacy N 20181231 59779-867_4b7e096a-9010-4937-8856-9583de164332 59779-867 HUMAN OTC DRUG CVS Sodium Chloride, Sodium Bicarbonate KIT 20140701 UNAPPROVED DRUG OTHER CVS Pharmacy N 20181231 59779-868_a9f3d047-befb-4f07-9e4f-04f64ea59ddd 59779-868 HUMAN OTC DRUG Daytime Non Drowsy ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20150930 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 59779-869_ae7f46f4-756c-44dc-8006-5f48efe1be9e 59779-869 HUMAN OTC DRUG Childrens Allergy Relief Dye Free Diphenhydramine HCl TABLET, CHEWABLE ORAL 20150320 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20181231 59779-870_442091b7-d00b-4b01-b7a5-a08bd38b3a97 59779-870 HUMAN OTC DRUG Cold Relief Multi-Symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, FILM COATED ORAL 20050715 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 59779-871_f51bbfd1-839a-4676-9ace-bd25be9cad3c 59779-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 19920715 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc HYDROGEN PEROXIDE 30 mg/mL N 20181231 59779-872_2d19e6fe-b133-464c-8ab8-2d40b97bcc50 59779-872 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen LIQUID ORAL 20150831 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/15mL N 20181231 59779-873_0dad652d-8e1f-4cb8-b958-a4bd20e03e52 59779-873 HUMAN OTC DRUG nicotine Nicotine polacrilex LOZENGE ORAL 20060222 ANDA ANDA077007 CVS Pharmacy NICOTINE 4 mg/1 N 20181231 59779-874_dc012cc4-22fe-47e7-821b-8c80ecdc72a4 59779-874 HUMAN OTC DRUG allergy relief childrens Diphenhydramine HCl SOLUTION ORAL 20150903 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 59779-875_290ab1af-3b1e-4cb0-982b-7a780eecb5a3 59779-875 HUMAN OTC DRUG CVS Health Natural Daily Fiber Sugar Free Natural Fiber Psyllium Husk POWDER ORAL 20150817 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy,Inc. PSYLLIUM HUSK 3.4 g/5.89g N 20181231 59779-876_5e8ba684-6586-4009-aab8-b1ae43b60797 59779-876 HUMAN OTC DRUG CVS Health Nighttime Severe Cough and Cold Nighttime Severe Cold and Cough ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE POWDER, FOR SOLUTION ORAL 20150817 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 59779-876_846b937f-0102-4dd9-afa1-15a58af4cd03 59779-876 HUMAN OTC DRUG CVS Health Nighttime Severe Cough and Cold Nighttime Severe Cold and Cough ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE POWDER, FOR SOLUTION ORAL 20150817 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 59779-877_632c20c7-d4a1-4cea-ac36-54e3bd5f0674 59779-877 HUMAN OTC DRUG CVS Health Multi Symptom Severe Cold MULTI SYMPTOM SEVERE COLD ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl POWDER, FOR SOLUTION ORAL 20150721 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 59779-878_109364ac-db36-4f23-8c16-ee9aa5c3a01e 59779-878 HUMAN OTC DRUG cortisone Hydrocortisone LOTION TOPICAL 20120410 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy HYDROCORTISONE 1 g/100g N 20181231 59779-879_46a09319-f1ca-4c00-99ae-cb55f0134005 59779-879 HUMAN OTC DRUG PMS Relief Maximum Strength Acetaminophen, Pamabrom, Pyrilamine Maleate TABLET, FILM COATED ORAL 20151113 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 59779-880_053954cf-19d0-4936-89b9-27942b32c22a 59779-880 HUMAN OTC DRUG CVS Health Extra Strength Heartburn Relief Antacid Original Flavor aluminum hydroxide and magnesium carbonate TABLET, CHEWABLE ORAL 20150827 OTC MONOGRAPH FINAL part331 CVS Pharmacy,Inc. ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 N 20181231 59779-881_628b2cd9-c4d4-4a16-aaf1-23eb954baae8 59779-881 HUMAN OTC DRUG SINUS RELIEF Maximum Strength Daytime and Nighttime Sinus Pain Acetaminophen, Guaifenesin, Diphenhydramine HCl, Phenylephrine HCl KIT 20130630 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-882_77a5ece7-ab12-4946-aa7c-7f8610af2bd6 59779-882 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20140209 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL N 20181231 59779-883_4933d61a-3af0-4e33-9c88-0840dc167ee7 59779-883 HUMAN OTC DRUG CVS Health Anti-Diarrheal Vanilla Bismuth subsalicylate SUSPENSION ORAL 20150811 OTC MONOGRAPH FINAL part335 CVS Pharmacy,Inc. BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 59779-884_5712e1d7-1565-4866-beef-298703b359bf 59779-884 HUMAN OTC DRUG Allergy Relief Childrens cetirizine Hydrochloride LIQUID ORAL 20100818 ANDA ANDA090254 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 59779-886_5e7ab774-414b-41c1-bee0-70656e7cac84 59779-886 HUMAN OTC DRUG Childrens Stuffy Nose and Cold Guaifenesin, Phenylephrine hydrochloride SOLUTION ORAL 20150605 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 100; 2.5 mg/5mL; mg/5mL N 20181231 59779-888_df5d4487-9d47-4636-971f-3fa1c5376dcf 59779-888 HUMAN OTC DRUG CVS PHARMACY JUICY PEAR BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140126 OTC MONOGRAPH NOT FINAL part333E CVS PHARMACY BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59779-889_9f323be9-707e-4e88-a5ba-d417ebcf8476 59779-889 HUMAN OTC DRUG SEVERE COLD AND FLU RELIEF Acetaminophen, Dextromethorphan HBr, Guiafenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050804 20181123 OTC MONOGRAPH FINAL part341 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 59779-890_d4afb0fb-f3cc-4484-8d8b-de7dae4fb0bc 59779-890 HUMAN OTC DRUG Childrens Daytime Cold and Cough Dextromethorphan HBr, Phenylephrine hydrochloride LIQUID ORAL 20150919 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 59779-892_214442fd-72c8-4bd9-9afa-27ddc48c2ff4 59779-892 HUMAN OTC DRUG loperamide hydrochloride Loperamide HCl TABLET, FILM COATED ORAL 20151006 ANDA ANDA075232 CVS Pharmacy LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 59779-893_2720ef94-6862-4d5d-8eb2-78f7bd46c9e2 59779-893 HUMAN OTC DRUG CVS Health Nighttime Sleep-Aid DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20150922 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 59779-893_acdd1000-538b-4bed-bf41-c464305d4181 59779-893 HUMAN OTC DRUG CVS Health Nighttime Sleep-Aid DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20150211 OTC MONOGRAPH FINAL part338 CVS Pharmacy,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 59779-893_e8785ba8-e53e-491e-bbfe-04e860f36131 59779-893 HUMAN OTC DRUG CVS Health Nighttime Sleep-Aid DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20160714 OTC MONOGRAPH FINAL part338 CVS Pharmacy,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 59779-894_5337d3ed-f3ce-4c73-b3c8-a0e2aa7b893b 59779-894 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Aspirin, Diphenhydramine citrate TABLET, FILM COATED ORAL 20160831 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; ASPIRIN; DIPHENHYDRAMINE CITRATE 250; 250; 38 mg/1; mg/1; mg/1 N 20181231 59779-895_4fb880db-2185-41ef-a5f9-8983a28d2c5b 59779-895 HUMAN OTC DRUG CVS Health Sore Throat Fast Relief Oral Anesthetic Phenol SPRAY ORAL 20150818 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy,Inc. PHENOL 1.4 g/100mL N 20181231 59779-896_7b67aaaf-3278-4c5f-8f7a-4549a3e2a24d 59779-896 HUMAN OTC DRUG CVS Health Soluble Fiber Therapy methylcellulose POWDER, FOR SOLUTION ORAL 20150930 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy,Inc. METHYLCELLULOSE (4000 MPA.S) 2 g/10.2g N 20181231 59779-897_9a89022a-d2b7-48ce-8302-b1d3a273d2ce 59779-897 HUMAN OTC DRUG ibuprofen childrens Ibuprofen SUSPENSION ORAL 19990107 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL N 20181231 59779-898_6767d7d9-a1b9-430c-abac-cbb85ff56115 59779-898 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 20090512 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 59779-899_dd82a811-9d34-4e8f-8564-19546fa05e0e 59779-899 HUMAN OTC DRUG CVS Pharmacy Reflective White Fluoride PASTE, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 CVS Pharmacy SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 59779-900_805c7ea8-7448-43ff-9feb-1ce985d469dc 59779-900 HUMAN OTC DRUG Ear Pain Relief Ear Drops Chamomilla and Mercurius solubilis and Sulphur SOLUTION AURICULAR (OTIC) 20071001 UNAPPROVED HOMEOPATHIC Woonsocket Prescription Center (CVS) CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR 10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59779-901_73605039-fd7c-4a23-9a93-1c1b9e12507e 59779-901 HUMAN OTC DRUG Pink Eye Relief Belladonna and Euphrasia and Hepar sulphuris SOLUTION/ DROPS OPHTHALMIC 20071001 UNAPPROVED HOMEOPATHIC Woonsocket Prescription Center (CVS) ATROPA BELLADONNA; EUPHRASIA STRICTA; CALCIUM SULFIDE 6; 6; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 59779-903_ebbab0e3-97fa-46a2-8e80-6bfdfc851bc5 59779-903 HUMAN OTC DRUG Multi Symptom Cold Relief Childrens Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl SUSPENSION ORAL 20090311 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 59779-904_e076a12b-0aea-47fd-9d91-9bfdeeea4533 59779-904 HUMAN OTC DRUG CVS Advanced Healing Petrolatum OINTMENT TOPICAL 20110212 OTC MONOGRAPH FINAL part347 CVS PETROLATUM 410 mg/g E 20171231 59779-905_8ccfb6e8-2d51-4854-9261-570485c9602c 59779-905 HUMAN OTC DRUG Pain Relief PM acetaminophen, diphenhydramine hydrochloride LIQUID ORAL 20150409 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/15mL; mg/15mL N 20181231 59779-907_c209a1be-853d-455d-9837-b3ed97dbfa56 59779-907 HUMAN OTC DRUG Childrens Cough and Chest Congestion DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150626 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 59779-909_d4f8b213-33d3-4591-8446-c86b6fb29720 59779-909 HUMAN OTC DRUG All Day Moisture Octinoxate, Zinc Oxide LOTION TOPICAL 20050715 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; ZINC OXIDE 61.2; 30.6 mg/mL; mg/mL N 20181231 59779-911_780df643-74fa-455b-a01e-920bd3e841bc 59779-911 HUMAN OTC DRUG CVS Sheer SFP 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20150714 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE 2; 5.5; 4; 4.5 g/100g; g/100g; g/100g; g/100g N 20181231 59779-913_de38b65d-5091-47e8-b160-76b398f9998f 59779-913 HUMAN OTC DRUG CVS Pharmacy Mouth Sore Gel Benzocaine GEL, DENTIFRICE ORAL 20121001 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE; BENZALKONIUM CHLORIDE; ZINC CHLORIDE 20; .02; .1 g/100g; g/100g; g/100g N 20181231 59779-914_4bb09d92-935a-46f0-82cb-26b25ded3c26 59779-914 HUMAN OTC DRUG naproxen sodium Naproxen sodium TABLET, FILM COATED ORAL 20150722 ANDA ANDA074661 CVS Pharmacy NAPROXEN SODIUM 220 mg/1 N 20181231 59779-915_17815ffb-d92b-43d1-8db8-cd419c3a7cd6 59779-915 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 19921117 20190419 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 59779-916_6102170f-9967-4994-aec2-5edc6c616059 59779-916 HUMAN OTC DRUG Cold, Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 59779-918_0d73c11e-a584-4577-8529-f4047b93e362 59779-918 HUMAN OTC DRUG Nicotine Polacrilex Nicotine polacrilex GUM, CHEWING ORAL 20140718 ANDA ANDA091354 CVS Pharmacy NICOTINE 4 mg/1 N 20181231 59779-920_9f478f87-f911-4253-859b-d2eee56a6889 59779-920 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140207 ANDA ANDA077958 CVS Pharmacy KETOTIFEN FUMARATE .35 mg/mL N 20181231 59779-921_7e5662ef-9849-48a9-9964-9914838a7556 59779-921 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20151122 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ALCOHOL 70 mL/100mL N 20181231 59779-922_7abc66f2-faf6-421c-9c3c-b69f5a587246 59779-922 HUMAN OTC DRUG CVS Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 59779-923_3bf196c1-a056-46d5-93aa-ef8413310bc6 59779-923 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, FILM COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 59779-924_35c7d54d-2cfc-4e14-a8d6-55775440a460 59779-924 HUMAN OTC DRUG cough dm childrens Dextromethorphan polistirex SUSPENSION ORAL 20150327 ANDA ANDA091135 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 59779-925_af141c8a-89b8-4216-a49d-bb30731115b1 59779-925 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION ORAL 20101201 ANDA ANDA079058 CVS Pharmacy IBUPROFEN 50 mg/1.25mL N 20181231 59779-926_93e85a7c-fcee-4732-b73f-458025ebd0b4 59779-926 HUMAN OTC DRUG Flu and Severe Cold Daytime Relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20150531 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 59779-927_4d9caaa2-1150-4d17-8f1a-a5bf9ed73cfb 59779-927 HUMAN OTC DRUG Head Congestion Cold Relief Severe Non-Drowsy Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 20190708 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 E 20171231 59779-928_46d34b24-faf1-476e-ab4b-b79793e8c63d 59779-928 HUMAN OTC DRUG Sinus Relief Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130503 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 59779-929_43ff53ea-d623-4a9a-854f-67bbddbde2e1 59779-929 HUMAN OTC DRUG CVS Pharmacy Hydrating Colloidal Oatmeal CREAM TOPICAL 20150501 OTC MONOGRAPH FINAL part347 CVS Pharmacy OATMEAL .001 mg/g N 20181231 59779-930_159ae768-5045-4db7-990d-057d4a0533e0 59779-930 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine, Pyrilamine maleate TABLET, FILM COATED ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 59779-931_c21acb63-ef79-4eef-8695-8a476611f54d 59779-931 HUMAN OTC DRUG CVS Pharmacy Instant Toothache Benzocaine GEL, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part333B CVS Pharmacy BENZOCAINE 20 g/100g N 20181231 59779-933_341caba8-cca4-48b6-a36b-c2413e9082ff 59779-933 HUMAN OTC DRUG Childrens Flu Relief Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, Phenylephrine HCI SUSPENSION ORAL 20150531 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 59779-934_c91428b4-ba36-4624-83fd-c24b59e6fabe 59779-934 HUMAN OTC DRUG CVS Health Natural Daily Fiber Sugar Free Natural Fiber Psyllium Husk POWDER ORAL 20150817 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy,Inc. PSYLLIUM HUSK 3.4 g/5.78g N 20181231 59779-935_f1889823-b6a3-453e-8e39-9f87e0bfcba8 59779-935 HUMAN OTC DRUG CVS Health Natural Daily Fiber Natural Fiber Psyllium Husk POWDER ORAL 20150818 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy,Inc. PSYLLIUM HUSK 3.4 g/12g N 20181231 59779-936_e1473bf4-884f-4f62-95e1-3f5ff240c9a9 59779-936 HUMAN OTC DRUG PMS FORMULA Maximum Strength Acetaminophen, Pamabrom, Pyrilamine maleate TABLET, FILM COATED ORAL 20000620 20190119 OTC MONOGRAPH NOT FINAL part343 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 E 20171231 59779-937_1b5b0f72-eb51-4e1c-8262-c49f3c55bcf7 59779-937 HUMAN OTC DRUG Flu and Severe Cold Nighttime Relief Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20150531 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 59779-938_0684a833-0bc4-4d2c-a725-e1170d9a9aa9 59779-938 HUMAN OTC DRUG Flu and Sore Throat Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20150531 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 59779-939_a4eac37b-e135-4bd8-aa49-998f87caec64 59779-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 59779-940_933d6e58-f6a9-4b12-95f0-c6cd9ac69967 59779-940 HUMAN OTC DRUG Mens Hair Regrowth Treatment extra strength Minoxidil SOLUTION TOPICAL 20000801 20180630 ANDA ANDA075518 CVS Pharmacy MINOXIDIL 50 mg/mL N 20191231 59779-941_dd9fe413-a858-4ff6-a353-9002d0f7c80a 59779-941 HUMAN OTC DRUG Cold Relief Multi Symptom Severe Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150531 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 59779-942_4d572cd4-810d-4d87-9070-749a45866f66 59779-942 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130913 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 59779-943_5b177115-9f0c-48a4-9fea-1f547436a2c9 59779-943 HUMAN OTC DRUG Kids Disappearing Color SPF50 Broad Spectrum Suncreen Green Apple Scented Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 10; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 59779-944_68b68cf5-b874-4c49-a294-3c7ad45d2cca 59779-944 HUMAN OTC DRUG Hemorrhoidal glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum CREAM TOPICAL 20080206 OTC MONOGRAPH FINAL part346 CVS Pharmacy GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 59779-945_211580f1-eb17-4735-b827-e3174f856a5b 59779-945 HUMAN OTC DRUG ASPIRIN Low Strength Aspirin TABLET, COATED ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ASPIRIN 81 mg/1 N 20191231 59779-946_2ba1e3f2-117e-4911-9303-393012809515 59779-946 HUMAN OTC DRUG infants pain and fever Acetaminophen SUSPENSION ORAL 20111214 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL N 20181231 59779-947_9a55083e-8df1-4c1b-bdfa-a2ce1e327b1e 59779-947 HUMAN OTC DRUG loperamide hydrochloride Loperamide HCl TABLET, FILM COATED ORAL 20151204 ANDA ANDA075232 CVS Pharmacy LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 59779-948_f6f9afd8-8066-437a-a5b5-6d2ceca7fba2 59779-948 HUMAN OTC DRUG Mucus Extended Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160419 ANDA ANDA091009 CVS Pharmacy GUAIFENESIN 1200 mg/1 N 20181231 59779-949_cd6c23c0-ec52-4f5e-9476-4934ae93ee91 59779-949 HUMAN OTC DRUG milk of magnesia Magnesium hydroxide SUSPENSION ORAL 20050505 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 59779-950_79fcb589-348d-4fd4-b333-4cf6030d97d8 59779-950 HUMAN OTC DRUG acid reducer Ranitidine TABLET, FILM COATED ORAL 20110921 ANDA ANDA091429 CVS Pharmacy RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 59779-951_ad826ca2-4490-4a8a-a843-fb47d3e9647c 59779-951 HUMAN OTC DRUG Instant Hand sanitizer ALCOHOL GEL TOPICAL 20110429 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ALCOHOL 65 kg/100L N 20181231 59779-952_7ef75bd9-081e-43cb-8a70-a99107285c82 59779-952 HUMAN OTC DRUG Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19980815 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc PYRITHIONE ZINC 10 mg/mL N 20181231 59779-953_e0e052ae-b06f-4f8c-8614-9b50af3152ae 59779-953 HUMAN OTC DRUG Sinus PE Decongestant Maximum Strength Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 CVS Pharmacy PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 59779-955_ea3ed882-3f71-4bca-b259-5363ca6d63fc 59779-955 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130113 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ALCOHOL 700 mg/mL N 20181231 59779-956_650257e0-f43f-4457-ae43-9ead1a67aece 59779-956 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part338 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 59779-957_34256b08-5574-4e2c-9df6-c7005cee7235 59779-957 HUMAN OTC DRUG Nicotine Nicotine Polacrilex LOZENGE ORAL 20130213 ANDA ANDA203690 CVS Pharmacy NICOTINE 4 mg/1 N 20181231 59779-958_5e4ff1d5-00d1-41a9-a1cd-d30d8819ba49 59779-958 HUMAN OTC DRUG Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130716 ANDA ANDA091135 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 59779-959_b305a8af-9bf8-4760-97b2-1b9ca44d7aaf 59779-959 HUMAN OTC DRUG CVS Pharmacy Saline Laxative ENEMA RECTAL 20130308 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 59779-960_cea56d99-9f8a-4eb7-9d42-91ef9928cee8 59779-960 HUMAN OTC DRUG anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20030421 ANDA ANDA075232 CVS Pharmacy LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 59779-961_75210937-9de9-45a0-81e7-2690804356ec 59779-961 HUMAN OTC DRUG Salicylic Acid Astringent LIQUID TOPICAL 20090605 OTC MONOGRAPH FINAL part333D CVS Pharmacy, Inc SALICYLIC ACID 5 mg/mL N 20181231 59779-961_a2cea43e-cd04-466f-87c9-838419bffc2a 59779-961 HUMAN OTC DRUG Oil Free Acne Wash Salicylic Acid 2% LOTION TOPICAL 20141120 OTC MONOGRAPH FINAL part333D CVS Pharmacy, Inc SALICYLIC ACID 20.6 mg/mL N 20181231 59779-962_93be713c-b306-451e-be19-3fde3a924799 59779-962 HUMAN OTC DRUG Sinus PE plus Allergy Maximum Strength Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20050609 OTC MONOGRAPH FINAL part341 CVS Pharmacy CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 59779-963_39760745-38b6-4a0b-8165-06fe0eade6b0 59779-963 HUMAN OTC DRUG Therapeutic Dandruff Dandruff Shampoo SHAMPOO TOPICAL 20160311 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc SALICYLIC ACID 30 mg/mL N 20181231 59779-965_61304306-da22-5c75-e053-2a91aa0a7c6b 59779-965 HUMAN OTC DRUG CVS Pharmacy Anti-fungal Pen Maximum Strength Undecylenic Acid LIQUID TOPICAL 20121227 OTC MONOGRAPH FINAL part333C CVS Pharmacy UNDECYLENIC ACID 250 mg/mL N 20181231 59779-966_b928d838-6346-4e55-9550-98184639fde5 59779-966 HUMAN OTC DRUG Anticavity Rinse Sodium Fluoride MOUTHWASH ORAL 20100819 OTC MONOGRAPH FINAL part355 CVS Pharmacy, Inc SODIUM FLUORIDE 10.33 mg/mL N 20191231 59779-967_6a0826f8-759c-475f-bcd2-cdecb88f3058 59779-967 HUMAN OTC DRUG Tussin DMMaximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20090701 OTC MONOGRAPH FINAL part341 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL N 20181231 59779-968_6054b4b7-374e-4863-bbb7-4f641fc0fa40 59779-968 HUMAN OTC DRUG Daily Facial Moisturizer Octinoxate, Octisalate, Avobenzone LOTION TOPICAL 20160225 OTC MONOGRAPH FINAL part352 CVS Pharmacy OCTINOXATE; OCTISALATE; AVOBENZONE 76.5; 51; 30.6 mg/mL; mg/mL; mg/mL N 20181231 59779-969_bec7129b-42c9-45cb-b2b7-b127415ed91e 59779-969 HUMAN OTC DRUG CVS Pharmacy Saline Laxative ENEMA RECTAL 20140520 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 3.5; 9.5 g/59mL; g/59mL N 20181231 59779-970_3811e210-f596-4a70-80f3-44327da1b9a7 59779-970 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20040408 20180609 OTC MONOGRAPH FINAL part336 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 E 20171231 59779-971_f564d239-f394-4607-8e55-895bb8e3ce09 59779-971 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20140129 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL N 20181231 59779-972_ecf1fa74-08dc-46d5-9f8f-3c2cdde925bc 59779-972 HUMAN OTC DRUG Tension Headache Aspirin-Free Acetaminophen, Caffeine TABLET ORAL 20090209 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 59779-973_8b9a4450-aaf2-48bb-a058-81ca630fb0d8 59779-973 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride SOLUTION ORAL 20151102 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/20mL N 20181231 59779-975_dee72e50-e33f-4d70-b3e8-e0039f0cd6a5 59779-975 HUMAN OTC DRUG pain relief extra strength Acetaminophen TABLET ORAL 19930806 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 N 20181231 59779-978_95e47612-dc34-4739-b180-97db58876848 59779-978 HUMAN OTC DRUG Allergy Relief childrens indoor/outdoor Cetirizine HCl TABLET, CHEWABLE ORAL 20081031 ANDA ANDA078692 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 59779-979_b9bd6779-8514-49a7-afc2-ed767377fdfb 59779-979 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET, FILM COATED ORAL 20150916 ANDA ANDA204507 CVS Pharmacy FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 59779-981_5eff766f-82e9-4cd6-e053-2a91aa0a4782 59779-981 HUMAN OTC DRUG CVS COLD AND HOT MEDICATED XL MENTHOL PATCH TOPICAL 20101111 OTC MONOGRAPH NOT FINAL part348 CVS PHARMACY, INC. MENTHOL 750 mg/1 N 20181231 59779-983_549a0c17-87e5-411c-8664-0b705b22776c 59779-983 HUMAN OTC DRUG CVS Homeopathic SKIN TAG REMOVER THUJA OCCIDENTALIS LEAFY TWIG LIQUID TOPICAL 20140625 UNAPPROVED HOMEOPATHIC CVS Pharmacy, Inc THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/10mL N 20181231 59779-984_5c89fcca-a9cf-4282-8e7f-d5502a2d1a70 59779-984 HUMAN OTC DRUG Childrens Cough and Cold CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL LIQUID ORAL 20150626 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 59779-985_b92ddc67-905e-495b-9d7c-d18a639238ad 59779-985 HUMAN OTC DRUG Allergy D Diphenhydramine HCl, Phenylephrine HCl TABLET ORAL 20050810 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 25; 10 mg/1; mg/1 N 20181231 59779-986_116a264b-4392-490a-9711-efa70d76f1e0 59779-986 HUMAN OTC DRUG Severe Congestion and Cough/Cold and Flu Daytime/Nighttime/Maximum Strength Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Acetaminophen, Diphenhydramine HCl KIT 20150720 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 59779-988_cf89e4cf-a94f-4d4b-b109-b1dc9a5138b1 59779-988 HUMAN OTC DRUG CVS Pharmacy Rash Cream Zinc oxide, Petrolatum CREAM TOPICAL 20140520 OTC MONOGRAPH FINAL part346 CVS Pharmacy ZINC OXIDE; PETROLATUM 13; 67 mg/mL; mg/mL E 20171231 59779-989_bb9b0056-dd3e-453d-9eb3-2bd870ea1469 59779-989 HUMAN OTC DRUG CVS Pharmacy Intensive Moisturizing Cream Dimethicone CREAM TOPICAL 20140520 OTC MONOGRAPH FINAL part347 CVS Pharmacy DIMETHICONE 12.5 mg/mL E 20171231 59779-990_ff03992a-4a49-4361-a481-fd0f5184c425 59779-990 HUMAN OTC DRUG Bisacody Enteric Coated Bisacodyl TABLET, COATED ORAL 20130110 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy BISACODYL 5 mg/1 N 20181231 59779-991_bcbfe1f1-6e96-4f45-bd96-79a84b94e193 59779-991 HUMAN OTC DRUG PAIN RELIEVING PATCH ULTRA STRENGTH ULTRA STRENGTH MENTHOL PATCH TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part348 CVS PHARMACY, INC. MENTHOL 50 mg/g N 20181231 59779-992_43a79914-0cdb-4caf-9306-76dad8dd3868 59779-992 HUMAN OTC DRUG Dye-Free Allergy Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20010913 20180723 OTC MONOGRAPH FINAL part336 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 59779-993_dd00c96d-5987-4680-a49b-d12919dfd009 59779-993 HUMAN OTC DRUG CVS Pharmacy Maximum Strength Feminine Wipes Pramoxine Hydrochloride CLOTH TOPICAL 20130321 OTC MONOGRAPH FINAL part346 CVS Pharmacy PRAMOXINE HYDROCHLORIDE 10 mg/g E 20171231 59779-995_8799ead6-b773-44b7-b3ad-a3bf6757bf5f 59779-995 HUMAN OTC DRUG infants ibuprofen ibuprofen SUSPENSION ORAL 19991108 ANDA ANDA075217 CVS Pharmacy IBUPROFEN 50 mg/1.25mL N 20181231 59779-996_ac07d170-94de-4e70-b454-1fc675c9875d 59779-996 HUMAN OTC DRUG Mineral Oil Lubricant Laxative mineral oil ENEMA RECTAL 20120716 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy MINERAL OIL 118 mL/118mL E 20171231 59779-997_df77c649-1fcb-4a6a-abf6-e3440b76a77c 59779-997 HUMAN OTC DRUG CVS Hemorrhoidal Topical Analgesic Dibucaine OINTMENT TOPICAL 20140117 OTC MONOGRAPH FINAL part346 CVS Pharmacy, Inc. DIBUCAINE 10 mg/g N 20181231 59779-999_2b66c4a1-fe5e-44da-abb0-064398fc95ba 59779-999 HUMAN OTC DRUG Sleep-Aid Regular Strength Diphenhydramine HCl TABLET ORAL 19900410 OTC MONOGRAPH FINAL part338 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 59788-001_60ab9f66-ad61-3b4b-e053-2991aa0af3eb 59788-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19860501 NDA NDA205712 Arcet Equipment Company dba Arc3 Gases North OXYGEN 995 mL/L N 20181231 59788-002_8dec34a4-3d0a-4e81-a10b-7f932c9f8c75 59788-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20070115 NDA NDA205713 Arcet Equipment Company dba Arc3 Gases North NITROGEN 990 mL/L N 20181231 59800-0107_23588395-6bd6-4a42-91e4-7178fdb59247 59800-0107 HUMAN OTC DRUG DERMAKLEAR AKNE TREATMENT WITH SULFUR SULFUR SOAP TOPICAL 20040701 OTC MONOGRAPH FINAL part358H Schwabe North America, Inc SULFUR 5 g/85g N 20181231 59800-0232_d8f2895b-7fce-4d09-a09b-e5f74b8e1c78 59800-0232 HUMAN OTC DRUG Air Power GUAIFENESIN TABLET ORAL 20030519 OTC MONOGRAPH FINAL part341 Schwabe North America, Inc GUAIFENESIN 200 mg/1 N 20181231 59800-7232_f9244633-5361-427c-aa70-17e36d61d303 59800-7232 HUMAN OTC DRUG MucaPlex GUAIFENESIN TABLET ORAL 20051001 OTC MONOGRAPH FINAL part341 Schwabe North America, Inc GUAIFENESIN 200 mg/1 N 20181231 59800-8001_403ef593-8bda-4e2f-8ba2-3ebdcff2e1c3 59800-8001 HUMAN OTC DRUG ViraClear EPs 7630 Original Pelargonium sidoides LIQUID ORAL 20090824 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc PELARGONIUM SIDOIDES ROOT 1 [hp_X]/30mL N 20181231 59800-8002_036352cd-717e-4db2-b32c-d5c7abe7b967 59800-8002 HUMAN OTC DRUG ViraClear EPs 7630 Cherry Flavor Pelargonium sidoides LIQUID ORAL 20090824 UNAPPROVED HOMEOPATHIC Schwabe North America, Inc PELARGONIUM SIDOIDES ROOT 1 [hp_X]/120mL N 20181231 59824-0008_bb7f3c11-acfb-4b01-829d-20d77054b54a 59824-0008 HUMAN OTC DRUG PainMed Homeopathic Pain Relieving External ACONITUM NAPELLUS, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA ALBA ROOT, CALENDULA OFFICINALIS Flowering TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, and RUTA GRAVEOLENS Flowering TOP GEL TOPICAL 20030801 UNAPPROVED HOMEOPATHIC G M International, Inc. ACONITUM NAPELLUS; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP 3; 6; 1; 12; 1; 2; 2; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 59834-202_d44b632d-0f53-4063-9479-27b5f9a92727 59834-202 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20110901 ANDA ANDA065326 OrchidPharma Inc CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 59834-203_d44b632d-0f53-4063-9479-27b5f9a92727 59834-203 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20110901 ANDA ANDA065326 OrchidPharma Inc CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 59842-012_f4006023-6212-43c8-9f08-e3b1ab89086e 59842-012 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010402 UNAPPROVED MEDICAL GAS Fitzsimmons Surgical Supply, Inc OXYGEN 99 L/100L E 20171231 59846-681_7dde6af8-4006-44c4-8d12-ff3998a8edfb 59846-681 HUMAN OTC DRUG PRO-SOURCE ANTIMICROBIAL HAND CLEANING WIPES BENZALKONIUM CHLORIDE CLOTH TOPICAL 20131017 OTC MONOGRAPH NOT FINAL part333E MSC Industrial Supply BENZALKONIUM CHLORIDE .01417 g/1 E 20171231 59854-299_981196fc-65d7-4163-8e0a-b8c78d03b3df 59854-299 HUMAN OTC DRUG Bacti-Free tm Hand Sanitizer ALCOHOL LIQUID TOPICAL 20080301 OTC MONOGRAPH NOT FINAL part333E Johnson Labs, Inc. ALCOHOL .29326 L/.473L N 20181231 59854-300_5c858de3-d3f8-434a-a651-d2ba9a5ff78f 59854-300 HUMAN OTC DRUG Bacti-Free tm Antibacterial Hand TRICLOSAN LIQUID TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333A Johnson Labs, Inc. TRICLOSAN .0189 L/3.78L N 20181231 59854-301_d76f4f10-eba1-455e-8568-2291e6fad7ad 59854-301 HUMAN OTC DRUG DELUXE ALL-PURPOSE TRICLOSAN LIQUID TOPICAL 20000101 OTC MONOGRAPH NOT FINAL part333A Johnson Labs, Inc. TRICLOSAN 7.57 mL/3.78L N 20181231 59860-519_1d5d7de1-7c91-4713-aaee-bac2ad0073cb 59860-519 HUMAN OTC DRUG IRIS ANTIMICROBIAL HAND SANITIZER ALCOHOL SOAP TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333E Smart and Final Stores ALCOHOL .62 mL/mL E 20171231 59860-545_50ded083-b0da-4abb-9374-3cfa3ec769a4 59860-545 HUMAN OTC DRUG IRIS ANTIMICROBIAL HAND CHLOROXYLENOL SOAP TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333E SMART AND FINAL STORES CHLOROXYLENOL 3 g/1000mL E 20171231 59862-100_af476c82-6637-431f-8ba3-e2816cc19135 59862-100 HUMAN OTC DRUG Sha-lem Palmitic Acid, Stearic Acid, Oleic Acid, Bismuth Subcarbonate, Boric Acid OINTMENT TOPICAL 19920508 UNAPPROVED DRUG OTHER Shalem Products, Inc. PALMITIC ACID; STEARIC ACID; OLEIC ACID; BISMUTH SUBCARBONATE; BORIC ACID 7.25; 7.25; 14.5; 1.89; .95 g/30mL; g/30mL; g/30mL; g/30mL; g/30mL N 20181231 59863-325_0b56ab35-71e8-4a91-b00e-61369250e193 59863-325 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990104 UNAPPROVED MEDICAL GAS Banner Home Care of Arizona OXYGEN 99 L/100L E 20171231 59875-1005_21f8e5e3-59bb-41b5-8d95-ae7900994a4a 59875-1005 HUMAN OTC DRUG Lab1796 Cold and Flu Armor Aconitum napellus, Onion, Arnica montana, Antropa Belladonna, Solanum Dulcamara Top, Eupatorium Cannabinum Whole Flowering, Gelsemium Sempervirens Root PELLET ORAL 20110101 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ACONITUM NAPELLUS; ONION; ARNICA MONTANA; ATROPA BELLADONNA; SOLANUM DULCAMARA TOP; EUPATORIUM CANNABINUM WHOLE FLOWERING; GELSEMIUM SEMPERVIRENS ROOT 14; 8; 8; 8; 8; 8; 18 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59875-1010_848732bf-c7c5-4f2c-8f80-176ef65be280 59875-1010 HUMAN OTC DRUG Lab1796 Sinus Appeaser Asafetida, Echinacea angustifolia, Calcium sulfide, Potassium dichromate, Luffa operculata fruit, Silicon dioxide, Sinusitisinum PELLET ORAL 20110115 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ASAFETIDA; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LUFFA OPERCULATA FRUIT; SILICON DIOXIDE; SINUSITISINUM 8; 12; 8; 18; 9; 10; 18 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1 N 20181231 59875-1015_8d8f2b97-8138-49b0-87e3-c84801f2dc6c 59875-1015 HUMAN OTC DRUG Lab1796 Sore Throat Soothe Aconitum napellus, Apis mellifera, Atropa belladonna, Solanum dulcamara top, Mercurius solubilis, Phytolacca americana root PELLET ORAL 20110101 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; SOLANUM DULCAMARA TOP; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT 10; 10; 10; 8; 10; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59875-1020_f571a1b5-9535-45ea-bbab-148e60a283ad 59875-1020 HUMAN OTC DRUG Lab1796 Allergy Escape Onion, Apis mellifera, Drosera rotundifolia, Euphrasia stricta, Histamine dihydrochloride, Urtica urens SPRAY ORAL 20111001 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ONION; APIS MELLIFERA; DROSERA ROTUNDIFOLIA; EUPHRASIA STRICTA; HISTAMINE DIHYDROCHLORIDE; URTICA URENS 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 59875-2005_55eb29b4-2540-4698-879e-298b38d56705 59875-2005 HUMAN OTC DRUG Lab1796 Stress Absorber Strychnos nux-vomica seed, Silver nitrate, Datura stramonium, Strychnos ignatii seed, Phosphoric acid, Matricaria recutita, Coffee bean PELLET ORAL 20110115 UNAPPROVED HOMEOPATHIC HomeopathyStore.com STRYCHNOS NUX-VOMICA SEED; SILVER NITRATE; DATURA STRAMONIUM; STRYCHNOS IGNATII SEED; PHOSPHORIC ACID; MATRICARIA RECUTITA; COFFEE BEAN 10; 10; 10; 10; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59875-2010_7c96fc52-32cd-4f4c-995e-ef3ea27acef7 59875-2010 HUMAN OTC DRUG Lab1796 Anxiety Shield Aconitum napellus, Silver nitrate, Arsenic trioxide, Matricaria recutita, Coffee Bean, Gelsemium sempervirens root, Strychnos ignatii seed PELLET ORAL 20110115 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; MATRICARIA RECUTITA; COFFEE BEAN; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED 30; 12; 30; 12; 9; 9; 9 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59875-3005_ed9167d8-289e-478d-9bfd-f89364f4afb5 59875-3005 HUMAN OTC DRUG Lab1796 High Blood Pressure Guard Barium carbonate, Atropa belladonna, Nitroglycerin, Lycopus virginicus, Strychnos nux-vomica seed, Lead PELLET ORAL 20110115 UNAPPROVED HOMEOPATHIC HomeopathyStore.com BARIUM CARBONATE; ATROPA BELLADONNA; NITROGLYCERIN; LYCOPUS VIRGINICUS; STRYCHNOS NUX-VOMICA SEED; LEAD 4; 4; 4; 6; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59875-3010_7ef48de9-ef85-4f4e-9999-bb5c20fca4b3 59875-3010 HUMAN OTC DRUG Lab1796 Cholsterol Watch Arctium lappa root, Berberis vulgaris root bark, Silybum marianum seed, Chelidonium majus, Cholesterol, Chrysanthellum indicum subsp. afroamericanum, Solidago virgaurea flowering top, Taraxacum offici PELLET ORAL 20110115 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ARCTIUM LAPPA ROOT; BERBERIS VULGARIS ROOT BARK; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CHOLESTEROL; CHRYSANTHELLUM INDICUM SUBSP. AFROAMERICANUM; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 4; 4; 4; 4; 9; 4; 4; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 59875-4005_27c8c1b9-1bb8-4385-9f7d-af595d6d09f9 59875-4005 HUMAN OTC DRUG Lab1796 Headache Ease Atropa Belladonna, Cyclamen purpurascens tuber, Coffee Bean, Iris versicolor root, Strychnos nux-vomica seed, Sanguinaria canadensis root, Spigelia marilandica root, Viburnum opulus bark PELLET ORAL 20110801 UNAPPROVED HOMEOPATHIC HomeopathyStore.com ATROPA BELLADONNA; CYCLAMEN PURPURASCENS TUBER; COFFEE BEAN; IRIS VERSICOLOR ROOT; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SPIGELIA MARILANDICA ROOT; VIBURNUM OPULUS BARK 8; 8; 4; 8; 9; 8; 8; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59875-9001_6aa603d0-c957-4a68-82ca-5eb803b6d5b3 59875-9001 HUMAN OTC DRUG Lab1796 Detox Escort Horse chestnut,Antimony trisulfide,Silver nitrate,Arnica montana,Berberis vulgaris root bark,Activated charcoal,Ceanothus americanus leaf,Cholesterol,Cinchona officinalis bark,Artichoke,Equisetum arve SOLUTION/ DROPS ORAL 20110115 UNAPPROVED HOMEOPATHIC HomeopathyStore.com HORSE CHESTNUT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; ACTIVATED CHARCOAL; CEANOTHUS AMERICANUS LEAF; CHOLESTEROL; CINCHONA OFFICINALIS BARK; ARTICHOKE; EQUISETUM ARVENSE TOP; CONYZA CANADENSIS; FUCUS VESICULOSUS; GINKGO; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; ARCTIUM LAPPA ROOT; LESPEDEZA CAPITATA FLOWERING TOP; RANUNCULUS BULBOSUS; DAIKON; ROBINIA PSEUDOACACIA BARK; TARAXACUM OFFICINALE; VIBURNUM PRUNIFOLIUM BARK; WINE GRAPE 6; 6; 10; 6; 6; 9; 6; 10; 8; 6; 6; 6; 6; 10; 6; 6; 6; 6; 6; 4; 6; 10; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 59877-0001_bcf1c0b1-808b-4ba1-b290-075d201e5930 59877-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850801 UNAPPROVED MEDICAL GAS Link Medical, Inc. OXYGEN 99 L/100L E 20171231 59883-004_5e81f073-c0cb-aa38-e053-2a91aa0ab37b 59883-004 HUMAN OTC DRUG Fluoridex Stannous Fluoride Rinse LIQUID ORAL 20160111 OTC MONOGRAPH FINAL part355 DEN-MAT HOLDINGS, LLC STANNOUS FLUORIDE 1.53 mg/g N 20181231 59883-015_5fd66061-55f8-52aa-e053-2a91aa0a7202 59883-015 HUMAN PRESCRIPTION DRUG FLUORIDEX Sodium Fluoride PASTE, DENTIFRICE DENTAL 20170106 UNAPPROVED DRUG OTHER DEN-MAT HOLDINGS, LLC. SODIUM FLUORIDE 5 mg/g N 20181231 59883-016_5fd60635-4b67-15e3-e053-2991aa0ab23a 59883-016 HUMAN PRESCRIPTION DRUG FLUORIDEX Sodium Fluoride PASTE, DENTIFRICE DENTAL 20161230 UNAPPROVED DRUG OTHER DEN-MAT HOLDINGS, LLC. SODIUM FLUORIDE 5 mg/g N 20181231 59883-020_6014c330-3699-027c-e053-2a91aa0a64e5 59883-020 HUMAN PRESCRIPTION DRUG FLUORIDEX Sodium Fluoride PASTE, DENTIFRICE DENTAL 20170103 UNAPPROVED DRUG OTHER DEN-MAT HOLDINGS, LLC. SODIUM FLUORIDE 5 mg/g N 20181231 59883-030_616bfbf4-fa62-0956-e053-2a91aa0a24c6 59883-030 HUMAN PRESCRIPTION DRUG FLUORIDEX Sodium Fluoride PASTE, DENTIFRICE DENTAL 20170106 UNAPPROVED DRUG OTHER DENT-MAT HOLDINGS, LLC. SODIUM FLUORIDE; POTASSIUM NITRATE 5; 50 mg/g; mg/g N 20191231 59883-031_61cedbd3-55b4-393a-e053-2a91aa0a11fe 59883-031 HUMAN PRESCRIPTION DRUG FLUORIDEX Sodium Fluoride PASTE, DENTIFRICE DENTAL 20161221 UNAPPROVED DRUG OTHER DENT-MAT HOLDINGS, LLC. POTASSIUM NITRATE; SODIUM FLUORIDE 50; 5 mg/g; mg/g N 20191231 59883-100_d0284899-a052-4ddd-baad-cc362309a40d 59883-100 HUMAN PRESCRIPTION DRUG ATRIDOX Doxycycline Hyclate KIT ORAL 20161201 NDA NDA050751 Den-Mat Holdings, LLC N 20181231 59883-168_7f549575-e740-4963-b105-ef4b4f850a2d 59883-168 HUMAN OTC DRUG Pro-Den Rx Sodium Fluoride GEL ORAL 20081121 OTC MONOGRAPH FINAL part352 Zila Therapeutics, Inc. SODIUM FLUORIDE .044 mL/mL E 20171231 59883-175_baf1cc5c-1786-45aa-8c36-1b6927d031fb 59883-175 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090618 ANDA ANDA077789 Den-mat Holdings, Llc CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 59883-720_7191e845-ca7b-451e-b43e-dba3ca59f6b5 59883-720 HUMAN OTC DRUG Pro-Den Rx Stannous Fluoride GEL ORAL 20081031 UNAPPROVED DRUG OTHER Den-mat Holdings, Llc STANNOUS FLUORIDE 1.8 g/g E 20171231 59883-820_beb13947-14f8-4eef-9082-690f7cd521e8 59883-820 HUMAN OTC DRUG Pro-Den Rx Sodium Fluoride GEL ORAL 20081031 OTC MONOGRAPH FINAL part355 Zila Therapeutics, Inc. SODIUM FLUORIDE 4.3 g/g E 20171231 59883-821_1e7e7d6a-d14d-4542-9e0b-7f122d75e9ae 59883-821 HUMAN OTC DRUG Pro-Den Rx Sodium Fluoride GEL ORAL 20081121 OTC MONOGRAPH FINAL part352 Zila Therapeutics, Inc. SODIUM FLUORIDE 4.3 g/g E 20171231 59883-824_ff00bc3a-14d3-4767-9efc-22036d4e02c5 59883-824 HUMAN PRESCRIPTION DRUG Pro-Den Rx Sodium Fluoride GEL ORAL 20090120 UNAPPROVED DRUG OTHER Den-mat Holdings, Llc SODIUM FLUORIDE 4.3 g/g E 20171231 59883-911_6ff14a6b-83f8-4c9a-9f9b-80ec73d17fc1 59883-911 HUMAN PRESCRIPTION DRUG Pro-Den Rx Sodium Fluoride RINSE ORAL 20081021 UNAPPROVED DRUG OTHER Den-mat Holdings, Llc SODIUM FLUORIDE .9 mg/mL E 20171231 59883-912_3a6c5ea3-3495-4562-b784-e97c6aff30b9 59883-912 HUMAN PRESCRIPTION DRUG Pro-Den Rx Sodium Fluoride RINSE ORAL 20081021 UNAPPROVED DRUG OTHER Den-mat Holdings, Llc SODIUM FLUORIDE .9 mg/mL E 20171231 59883-920_7e7725e0-5217-4775-b312-217379f7058b 59883-920 HUMAN PRESCRIPTION DRUG Pro-Den Rx Sodium Fluoride RINSE ORAL 20081021 UNAPPROVED DRUG OTHER Den-mat Holdings, Llc SODIUM FLUORIDE .9 mg/mL E 20171231 59886-304_02d8f0fb-f916-4a68-9c13-549489df62be 59886-304 HUMAN OTC DRUG ULTRASOL nature BABY Sunscreen Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd TITANIUM DIOXIDE; ZINC OXIDE 15; 8 g/100g; g/100g N 20181231 59886-308_b0d3f0b1-41ec-45b8-8d70-60fae969f660 59886-308 HUMAN OTC DRUG UltrasolSunscreen KIDS Sunscreen Lotion SPF 34 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 3; 3 g/100g; g/100g; g/100g; g/100g N 20181231 59886-309_72bcd16f-9353-4677-ac76-8d60fc705466 59886-309 HUMAN OTC DRUG UltrasolSunscreen KIDS Sunscreen Lotion Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 59886-315_e9cb9def-999e-4e0e-8db2-72e2203e8663 59886-315 HUMAN OTC DRUG UltrasolSunscreen KIDS Sunscreen Spray Lotion SPF 30 Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 7.5; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59886-316_52182e84-280a-41db-b234-fc974b30a8f3 59886-316 HUMAN OTC DRUG UltrasolSunscreen KIDS Sunscreen Mousse Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, FOAM TOPICAL 20100410 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 9; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59886-318_e07969eb-b3a6-49f3-8463-bee2af800bdf 59886-318 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Lotion SPF 15 Avobenzone, Octisalate, Octocrylene LOTION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTOCRYLENE; OCTISALATE 2; 7; 5 g/100g; g/100g; g/100g N 20181231 59886-319_281820aa-02d6-4549-8ca2-c0e6a94e308e 59886-319 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Lotion SPF 34 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 3; 3 g/100g; g/100g; g/100g; g/100g N 20181231 59886-320_91453fc8-b945-4cdc-a3fd-5540b8158873 59886-320 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Lotion SPF 34 Avobenzone , Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 3; 3 g/100g; g/100g; g/100g; g/100g N 20181231 59886-322_dc7380b8-5a08-450d-91fd-c863d62f69f6 59886-322 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Lotion SPF45 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 59886-326_bf0fa058-ac30-4641-8233-31441b298770 59886-326 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Face Cream SPF 34 Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 3; 3 g/100g; g/100g; g/100g; g/100g N 20181231 59886-327_3ff7c8ee-af7b-4376-aff3-e2719fcaa027 59886-327 HUMAN OTC DRUG Ultrasol KIDS Sunscreen Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 59886-330_2b1ca574-2c21-4aba-8b89-0c24d34385f1 59886-330 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Spray Lotion SPF 15 Avobenzone, Octinoxate, Oxybenzone SPRAY TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer pharmaceuticals Ltd. AVOBENZONE; OCTINOXATE; OXYBENZONE 2; 7.5; 4 g/100g; g/100g; g/100g N 20181231 59886-336_c9fec2fe-1d6a-4006-b0ad-af98813d369f 59886-336 HUMAN OTC DRUG Ultrasol nature BABY Sunscreen Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 59886-337_1816044f-baee-4357-b24b-b2cf57b282a3 59886-337 HUMAN OTC DRUG UltrasolSunscreen nature BABY Sunscreen Face Cream SPF 45 Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 59886-338_b3178a66-5580-44fc-a0a4-71171c9af76a 59886-338 HUMAN OTC DRUG Ultrasol OIL-FREE Sunscreen Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 59886-339_b598d15e-72c4-4598-80a3-ff052b6fb494 59886-339 HUMAN OTC DRUG Ultrasol Sport Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 59886-340_b25ee570-a66f-4b6d-94fb-60d498536e77 59886-340 HUMAN OTC DRUG UltrasolSunscreen Sport Sunscreen Lotion CONTINUOUS SPRAY SPF 45 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 5; 7.5; 5; 9; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59886-343_8fd7e133-7190-467f-bd4a-7dd198b7695a 59886-343 HUMAN OTC DRUG UltrasolSunscreen Sunscreen Lotion Continuous Spray SPF 45 Avobenzone, Homosalate, Octinoxate , Octisalate , Octocrylene , Oxybenzone AEROSOL, SPRAY TOPICAL 20100430 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 5; 7.5; 5; 9; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59886-344_a6b8794d-3375-4323-9436-b16cb66579a3 59886-344 HUMAN OTC DRUG UltrasolSunscreen KIDS Sunscreen Lotion Continuous Spray SPF 45 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene , Oxybenzone AEROSOL, SPRAY TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 5; 7.5; 5; 9; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59886-346_6e5889d6-7bb8-45d0-b4e9-f58169edb683 59886-346 HUMAN OTC DRUG UltrasolSunscreen Clear CONTINUOUS SPRAY SPF43 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100410 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7.5; 5; 6; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59886-347_85f61e37-0741-4fd6-814b-09ecbba1fa02 59886-347 HUMAN OTC DRUG UltrasolSunscreen KIDS Clear CONTINUOUS SPRAY Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100410 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7.5; 5; 6; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59886-348_02939687-39e7-4d7b-b90a-bea57cc6332a 59886-348 HUMAN OTC DRUG UltrasolSunscreen Sport Clear CONTINUOUS SPRAY Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100410 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7.5; 5; 6; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59886-349_e4af34be-9c7f-4d8c-8d33-cb7581e497c7 59886-349 HUMAN OTC DRUG ULTRASOL nature BABY Sunscreen Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd TITANIUM DIOXIDE; ZINC OXIDE 15; 8 g/100g; g/100g N 20181231 59886-350_53985bf1-f1dc-4a0f-95cf-447040ff2bc6 59886-350 HUMAN OTC DRUG ULTRASOL Sport Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 5; 7.5; 5; 9; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59886-351_d7733ee0-7848-457c-a4e9-de015feeb87d 59886-351 HUMAN OTC DRUG ULTRASOL Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 5; 7.5; 5; 9; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59886-352_27f9ee8c-31fd-4c97-8209-c521eb2e4d1e 59886-352 HUMAN OTC DRUG ULTRASOL Sunscreen SPF45 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 5; 7.5; 5; 9; 5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59886-353_1a362e48-3a54-4443-97eb-5e996e920223 59886-353 HUMAN OTC DRUG ULTRASOL KIDS Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, FOAM TOPICAL 20100610 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 9; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 59886-354_e48d3a18-7ad3-4aa9-96de-2a8739db0505 59886-354 HUMAN OTC DRUG Ultrasol Sport Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20100625 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 59886-355_5426e82e-6214-4e8e-a36f-7f83796a1836 59886-355 HUMAN OTC DRUG ULTRASOL Sunscreen Lotion SPF 45 Avobenzone, Octinoxate, Octisalate, Oxyybenzone LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 Fischer Pharmaceuticals Ltd. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2; 7.5; 5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 59886-410_c9bcd009-a78c-494f-a0ac-fb13d9c90e60 59886-410 HUMAN OTC DRUG Asepxia Facial cleansing SALICYLIC ACID CLOTH TOPICAL 20110130 OTC MONOGRAPH FINAL part333D Fischer Pharmaceuticals Ltd. SALICYLIC ACID .5 g/100g E 20171231 59886-413_ea906a2b-f6fd-43ec-abc1-3f3187475c22 59886-413 HUMAN OTC DRUG Olivene Diaper Rash Zinc Oxide OINTMENT TOPICAL 20130111 OTC MONOGRAPH FINAL part347 Fischer Pharmaceuticlas Ltd. ZINC OXIDE 400 mg/g N 20181231 59886-414_17e936f0-b6f6-469b-b63b-eb410cd021c9 59886-414 HUMAN OTC DRUG Pure Baby Diaper Rash Zinc Oxide CREAM TOPICAL 20180101 OTC MONOGRAPH FINAL part347 Fischer Pharmaceuticals Ltd ZINC OXIDE 40 g/100g N 20181231 59896-520_7d8c729d-508a-4832-9254-600af3de1294 59896-520 HUMAN OTC DRUG MAYFAIR ANTI-BACTERIAL HAND SANITIZER ALCOHOL SOAP TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part333E Sellars Absorbent Materials ALCOHOL .62 mL/mL E 20171231 59896-682_2319b06e-741d-49fb-8a5a-c3afb6ac0b75 59896-682 HUMAN OTC DRUG MAYFAIR HAND SANITIZING WIPES WITH ALOE BENZALKONIUM CHLORIDE CLOTH TOPICAL 20131016 OTC MONOGRAPH NOT FINAL part333E Sellars Absorbent Materials BENZALKONIUM CHLORIDE .0067275 g/1 E 20171231 59898-120_6027c492-221e-6027-e053-2991aa0a3a5c 59898-120 HUMAN OTC DRUG R2 Avobenzone, Homosalate, Octinoxate, Octocrylene LOTION TOPICAL 20100814 OTC MONOGRAPH NOT FINAL part352 Water-Jel Technologies AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 7.5; 5; 2.7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 59898-121_a76faa2d-6b9d-4359-8eb5-33d47e5ae25b 59898-121 HUMAN OTC DRUG R2 Skin Protectant Dimethicone LOTION TOPICAL 20140201 OTC MONOGRAPH FINAL part332 Water-Jel Technologies DIMETHICONE 2 g/100g N 20181231 59898-122_fc2b9406-5f46-4634-8c87-f073ace97f8a 59898-122 HUMAN OTC DRUG Radiaderm System Kit Dimethicone LOTION TOPICAL 20140201 OTC MONOGRAPH FINAL part332 Water-Jel Technologies DIMETHICONE 2 g/100g N 20181231 59898-123_e8055f92-176a-472a-98c2-13b53a8df696 59898-123 HUMAN OTC DRUG Radiaderm Starter Kit Dimethicone LOTION TOPICAL 20140201 OTC MONOGRAPH FINAL part332 Water-Jel Technologies DIMETHICONE 2 g/100g N 20181231 59898-130_60283632-93f8-c77e-e053-2a91aa0aa9dc 59898-130 HUMAN OTC DRUG R2 System Avobenzone, Homosalate, Octinoxate, Octocrylene LOTION TOPICAL 20100814 OTC MONOGRAPH NOT FINAL part352 Water-Jel Technologies AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 7.5; 5; 2.7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 59898-140_5fc13f20-632f-7cf3-e053-2a91aa0aee0f 59898-140 HUMAN OTC DRUG EBSL-5 Lidocaine Hydrochloride KIT 20140611 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies N 20181231 59898-160_5fc0f081-b7a6-22e3-e053-2991aa0a4324 59898-160 HUMAN OTC DRUG EBSS-5 Lidocaine Hydrochloride KIT 20140611 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies N 20181231 59898-170_5fc0e70e-35a7-6fdd-e053-2a91aa0ad0b3 59898-170 HUMAN OTC DRUG FSK-5 Lidocaine Hydrochloride KIT 20140611 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies N 20181231 59898-180_5fc11494-a75c-7010-e053-2a91aa0afd34 59898-180 HUMAN OTC DRUG IWK-5 Lidocaine Hydrochloride KIT 20140612 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies N 20181231 59898-200_979ba421-bdc3-4fd0-b84d-d065cd057e9e 59898-200 HUMAN OTC DRUG Burn Jel Gel for Burns GEL TOPICAL 20100417 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies LIDOCAINE HYDROCHLORIDE 2 g/100mL N 20181231 59898-201_1c1ece31-8529-43e5-b805-c5d0dd3c1b81 59898-201 HUMAN OTC DRUG Burn Mist Lidocaine Hydrochloride SPRAY TOPICAL 20100517 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies LIDOCAINE HYDROCHLORIDE 2 g/100mL N 20181231 59898-202_5f4b670a-63df-dfc4-e053-2991aa0a4b1c 59898-202 HUMAN OTC DRUG Burn Jel Plus Gel for Burns GEL TOPICAL 20100410 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies LIDOCAINE HYDROCHLORIDE 2.5 g/100mL N 20181231 59898-401_5e0c6278-2f7e-7cd2-e053-2991aa0ad471 59898-401 HUMAN OTC DRUG First Aid Antiseptic Benzalkonium chloride SPRAY TOPICAL 20100522 OTC MONOGRAPH NOT FINAL part333A Water-Jel Technologies BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 59898-402_5e1b0e8c-34d6-2248-e053-2991aa0a63a6 59898-402 HUMAN OTC DRUG Isopro First Aid Isopropyl Alcohol SPRAY TOPICAL 20100523 OTC MONOGRAPH NOT FINAL part333A Water-Jel Technologies ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 59898-403_5e1b60d3-7da9-669f-e053-2991aa0ac65c 59898-403 HUMAN OTC DRUG Water Jel Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333A Water-Jel Technologies HYDROGEN PEROXIDE 3 mL/100mL N 20181231 59898-420_60b7758a-6bca-7eec-e053-2991aa0a9344 59898-420 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20100415 OTC MONOGRAPH NOT FINAL part333E Water-Jel Technologies ALCOHOL 62 mL/100mL N 20181231 59898-500_5f4b97f0-64af-6766-e053-2a91aa0abc98 59898-500 HUMAN OTC DRUG Unburn Lidocaine hydrochloride GEL TOPICAL 20130317 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies LIDOCAINE HYDROCHLORIDE 2.5 g/100mL N 20181231 59898-510_5f39ef62-2d41-a330-e053-2991aa0a7181 59898-510 HUMAN OTC DRUG Unburn Lidocaine hydrochloride SPRAY TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies LIDOCAINE HYDROCHLORIDE 2.5 g/100mL N 20181231 59898-720_5e1b6f62-4c93-0ff0-e053-2a91aa0af8ae 59898-720 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20101107 OTC MONOGRAPH FINAL part333B Water-Jel Technologies BACITRACIN ZINC 500 [iU]/g N 20181231 59898-730_5e1d7287-aa49-ec0e-e053-2a91aa0ac3dd 59898-730 HUMAN OTC DRUG Water-Jel Neomycin Antibiotic First Aid Ointment OINTMENT TOPICAL 20100331 OTC MONOGRAPH FINAL part333B Water-Jel Technologies NEOMYCIN SULFATE 3.5 mg/g N 20181231 59898-740_5e332a38-e153-d2c4-e053-2a91aa0abb49 59898-740 HUMAN OTC DRUG Water-Jel 3-in-1 Antibiotic Bacitracin zinc, Polymyxin B Sulfate, Neomycin Sulfate OINTMENT TOPICAL 20100330 OTC MONOGRAPH FINAL part333B Water-Jel Technologies BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE 417.8; 5322.8; 3.5 [iU]/g; [iU]/g; mg/g N 20181231 59898-800_5f3a246d-89bb-c7fd-e053-2991aa0a0201 59898-800 HUMAN OTC DRUG HYDROCORTISONE Anti-itch cream OINTMENT TOPICAL 20100430 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies HYDROCORTISONE ACETATE 1 g/100g N 20181231 59898-805_5f4b2958-3db5-a054-e053-2991aa0a84c9 59898-805 HUMAN OTC DRUG MUSCLE Menthol GEL TOPICAL 20100419 OTC MONOGRAPH NOT FINAL part348 WATER-JEL TECHNOLOGIES MENTHOL 3.5 g/100mL N 20181231 59898-810_5cf00a0c-835a-785c-e053-2991aa0af033 59898-810 HUMAN OTC DRUG Itch Relief Diphenhydramine Hydrochloride SPRAY TOPICAL 20100925 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies, LLC. DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100mL N 20181231 59898-902_5f3a0aa8-f1a3-6d47-e053-2a91aa0a77fa 59898-902 HUMAN OTC DRUG First Aid Burn Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20100420 OTC MONOGRAPH NOT FINAL part348 Water-Jel Technologies LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE .5; .13 g/100g; g/100g N 20181231 59899-001_6165bbb1-fbe9-4273-e053-2991aa0a8756 59899-001 HUMAN OTC DRUG Enfuselle Time Repair A.M. SPF15 HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20130807 OTC MONOGRAPH FINAL part352 Shaklee Corporation HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 50; 50; 30; 35 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 59899-002_6165bbb1-fbf8-4273-e053-2991aa0a8756 59899-002 HUMAN OTC DRUG enfuselle Acne Clarifying SALICYLIC ACID LOTION TOPICAL 20130808 OTC MONOGRAPH FINAL part333D Shaklee Corporation SALICYLIC ACID 5 mg/mL N 20191231 59899-003_0685c945-6862-45b6-8462-11d8bbe23c7a 59899-003 HUMAN OTC DRUG Antiperspirant Aluminum Chlorohydrate CREAM TOPICAL 20130808 OTC MONOGRAPH FINAL part350 SHAKLEE CORPORATION ALUMINUM CHLOROHYDRATE 20 g/100g E 20171231 59899-004_36da92f0-71cb-4ac3-bb5e-713077c6ff36 59899-004 HUMAN OTC DRUG Roll-On Antiperspirant Aluminum Chlorohydrate CREAM TOPICAL 20130808 OTC MONOGRAPH FINAL part350 SHAKLEE CORPORATION ALUMINUM CHLOROHYDRATE 200 mg/mL E 20171231 59899-005_60dc955d-c526-2b9b-e053-2991aa0a70ff 59899-005 HUMAN OTC DRUG Joint and Muscle Pain Menthol CREAM TOPICAL 20130808 OTC MONOGRAPH NOT FINAL part348 Shaklee Corporation MENTHOL 5 g/100g N 20181231 59899-006_6165c541-12d9-9ab6-e053-2a91aa0ae853 59899-006 HUMAN OTC DRUG Enfuselle Lip Treatment SPF 15 Broad Spectrum OCTISALATE, AVOBENZONE, and OCTOCRYLENE STICK TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Shaklee Corporation OCTISALATE; AVOBENZONE; OCTOCRYLENE 5; 3; 5 g/g; g/g; g/g N 20181231 59899-007_61658e59-3d35-4752-e053-2a91aa0ab252 59899-007 HUMAN OTC DRUG enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE, and OCTOCRYLENE LOTION TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Shaklee Corporation OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE 50; 30; 100; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 59899-008_6165bbb1-fc05-4273-e053-2991aa0a8756 59899-008 HUMAN OTC DRUG Joint and Muscle Pain Menthol CREAM TOPICAL 20131111 OTC MONOGRAPH NOT FINAL part348 Shaklee Corporation MENTHOL 5 g/100g N 20181231 59899-009_60c53de5-a1cc-cdd4-e053-2991aa0a17cb 59899-009 HUMAN OTC DRUG Youth Age Defense Mineral Moisturizer SPF 30 ZINC OXIDE LOTION TOPICAL 20170809 OTC MONOGRAPH NOT FINAL part352 Shaklee Corporation ZINC OXIDE 210 mg/mL N 20181231 59899-010_60c54274-4646-9b20-e053-2991aa0a0987 59899-010 HUMAN OTC DRUG Youth 1 Activating BB Cream SPF 30 Light ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20170809 OTC MONOGRAPH NOT FINAL part352 Shaklee Corporation ZINC OXIDE; TITANIUM DIOXIDE 63; 23.6 mg/mL; mg/mL N 20181231 59899-011_60c53de5-a1db-cdd4-e053-2991aa0a17cb 59899-011 HUMAN OTC DRUG Youth 2 Activating BB Cream SPF 30 Light Medium ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20170809 OTC MONOGRAPH NOT FINAL part352 Shaklee Corporation ZINC OXIDE; TITANIUM DIOXIDE 63; 23.6 mg/mL; mg/mL N 20181231 59899-012_60c53de5-a1ea-cdd4-e053-2991aa0a17cb 59899-012 HUMAN OTC DRUG Youth 3 Activating BB Cream SPF 30 Medium ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20170809 OTC MONOGRAPH NOT FINAL part352 Shaklee Corporation ZINC OXIDE; TITANIUM DIOXIDE 63; 23.6 mg/mL; mg/mL N 20181231 59899-013_60c549ea-12c8-d585-e053-2a91aa0a2600 59899-013 HUMAN OTC DRUG Youth 4 Activating BB Cream SPF 30 Dark ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20170809 OTC MONOGRAPH NOT FINAL part352 Shaklee Corporation ZINC OXIDE; TITANIUM DIOXIDE 63; 23.6 mg/mL; mg/mL N 20181231 59899-014_63ef1b6a-f5ae-f889-e053-2a91aa0ab5b0 59899-014 HUMAN OTC DRUG Shaklee Essentials Desert Wind Roll-On Antiperspirant Aluminum Chlorohydrate LOTION TOPICAL 20170605 OTC MONOGRAPH FINAL part350 Shaklee Corporation ALUMINUM CHLOROHYDRATE 160 mg/mL N 20191231 59899-015_63ef0555-9bd4-4d21-e053-2991aa0aa9f9 59899-015 HUMAN OTC DRUG Shaklee Essentials Desert Wind Roll-On Antiperspirant Aluminum Chlorohydrate CREAM TOPICAL 20170908 OTC MONOGRAPH FINAL part350 Shaklee Corporation ALUMINUM CHLOROHYDRATE 160 mg/g N 20191231 59899-020_63f11407-46d8-3314-e053-2991aa0a3734 59899-020 HUMAN OTC DRUG Shaklee Essentials Desert Wind Roll-On Antiperspirant Aluminum Chlorohydrate LOTION TOPICAL 20170605 OTC MONOGRAPH FINAL part350 Shaklee Corporation ALUMINUM CHLOROHYDRATE 160 mg/mL N 20191231 59899-021_63f11407-46d4-3314-e053-2991aa0a3734 59899-021 HUMAN OTC DRUG Shaklee Essentials Desert Wind Roll-On Antiperspirant Aluminum Chlorohydrate CREAM TOPICAL 20170908 OTC MONOGRAPH FINAL part350 Shaklee Corporation ALUMINUM CHLOROHYDRATE 160 mg/g N 20191231 59900-102_17c8f928-259f-4e8c-a682-ba263f3f8378 59900-102 HUMAN OTC DRUG Smart San Healthcare Personnel Handwash Ethanol LIQUID TOPICAL 20000601 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 710 g/1000mL N 20181231 59900-107_f3381727-30d0-4e87-b5c2-a0a19f727a8f 59900-107 HUMAN OTC DRUG Alpet E3 Hand Sanitizer Spray Isopropyl Alcohol LIQUID TOPICAL 19950101 OTC MONOGRAPH NOT FINAL part352 Best Sanitizer, Inc. ISOPROPYL ALCOHOL 760 g/1000mL N 20181231 59900-110_7d4b3f7f-716f-4e42-9630-ecde825b3d53 59900-110 HUMAN OTC DRUG Alpet E3 Plus Hand Sanitizer Spray Ethanol LIQUID TOPICAL 19990401 OTC MONOGRAPH NOT FINAL part352 Best Sanitizer, Inc. ETHANOL 710 g/1000mL N 20181231 59900-111_7c2c757b-1280-4f42-a2af-49794269ff18 59900-111 HUMAN OTC DRUG Smart San Hand Sanitizer Spray Ethanol LIQUID TOPICAL 20040701 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 710 g/1000mL N 20181231 59900-112_8d3682da-2120-4abf-8f83-76414f796a5f 59900-112 HUMAN OTC DRUG Smart San Hand Sanitizer Spray Fragrenace-Free Ethanol LIQUID TOPICAL 20040701 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 710 g/1000mL N 20181231 59900-114_ec24daaf-5db7-41eb-beb8-970c075b99df 59900-114 HUMAN OTC DRUG Smart San ES Hand Sanitizer Spray Ethanol LIQUID TOPICAL 20040701 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 652.2 g/1000mL N 20181231 59900-116_67eb6c79-c6a0-486d-ae41-2efdac98ccbb 59900-116 HUMAN OTC DRUG Smart San Hand Sanitizer Ethanol LIQUID TOPICAL 20010401 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 693 g/1000mL N 20181231 59900-117_c324e7db-5a74-4402-b9a8-42fa8c2700fe 59900-117 HUMAN OTC DRUG Smart San Hand Sanitizer Ethanol LIQUID TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 672 g/1000mL N 20181231 59900-118_6b256eac-d382-45c1-bcfa-e24be36f2f35 59900-118 HUMAN OTC DRUG Smart San Alcohol Free Hand Sanitizer Foam Benzalkonium Chloride LIQUID TOPICAL 20090715 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc BENZALKONIUM CHLORIDE 10 g/1000mL N 20181231 59900-120_6225a531-1741-497e-861e-dbbb1ef9d02c 59900-120 HUMAN OTC DRUG All Fresh by Alsco Instant Mist Hand Sanitizer Ethanol LIQUID TOPICAL 20050301 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc ETHANOL 710 g/1000mL N 20181231 59900-130_dd1049db-713c-44f5-a4ba-473eb815e34a 59900-130 HUMAN OTC DRUG Alpet Q E2 Benzalkonium Chloride LIQUID TOPICAL 20090715 OTC MONOGRAPH NOT FINAL part333E Best Sanitizers, Inc BENZALKONIUM CHLORIDE 1.2 g/1000mL N 20181231 59900-208_9a4581bf-af43-4f27-b19a-da3fe44fb143 59900-208 HUMAN OTC DRUG Alpet E2 Sanitizing Foam Soap Chloroxylenol SOAP TOPICAL 20080201 OTC MONOGRAPH NOT FINAL part352 Best Sanitizer, Inc. CHLOROXYLENOL 250 g/1000mL N 20181231 59900-211_d69a0eeb-a55e-4560-80e9-120ccfecf207 59900-211 HUMAN OTC DRUG Soften Sure Foam Soap Antimicrobial Chloroxylenol LIQUID TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part352 Best Sanitizers, Inc CHLOROXYLENOL 189 g/1000mL N 20181231 59900-510_243da975-37ea-4fa5-8d65-aeba9f0ce5b6 59900-510 HUMAN OTC DRUG HACCP Flat Top E-2 chloroxylenol LIQUID TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333E Best Sanitizers Inc. CHLOROXYLENOL 15.75 g/1000mL E 20171231 59900-718_616767bb-9a38-c5a8-e053-2991aa0ae30b 59900-718 HUMAN OTC DRUG HACCP QE2 Benzalkonium Chloride LIQUID TOPICAL 20140716 OTC MONOGRAPH NOT FINAL part333E Best Sanitizers, Inc BENZALKONIUM CHLORIDE 1200 ug/mL N 20181231 59910-0001_23c28f55-fcde-4489-a3d1-a596046d4e40 59910-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19760101 UNAPPROVED MEDICAL GAS McDonald Welding Supply, Inc OXYGEN 99 L/100L E 20171231 59915-1001_ebf42107-3f8a-4d91-91be-f346ce1961d0 59915-1001 HUMAN OTC DRUG Conju Princess BB arbutin CREAM TOPICAL 20110124 UNAPPROVED DRUG OTHER Conju Inc TITANIUM DIOXIDE; ARBUTIN; ADENOSINE 10.15; 2; .04 mL/100mL; mL/100mL; mL/100mL E 20171231 59915-2001_2b7eb435-cd7d-4c7d-af88-0759ba83b017 59915-2001 HUMAN OTC DRUG Conju Princess UV Sun Block ETHYLHEXYL METHOXYCINNAMATE CREAM TOPICAL 20101218 UNAPPROVED DRUG OTHER Conju Inc OCTINOXATE; ENZACAMENE; TITANIUM DIOXIDE; AVOBENZONE; ZINC OXIDE .075; .05; .0249; .03; .01 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL E 20171231 59915-3001_d98f97f2-0ec2-426f-aa41-9d7337678d87 59915-3001 HUMAN OTC DRUG Conju Princess BB arbutin CREAM TOPICAL 20101230 UNAPPROVED DRUG OTHER Conju Inc TITANIUM DIOXIDE; ARBUTIN; ADENOSINE 10.15; 2; .04 mL/100mL; mL/100mL; mL/100mL E 20171231 59915-4001_5c562987-f5a5-4c7a-a02a-ba93309f5633 59915-4001 HUMAN OTC DRUG Conju Princess UV Sun Block ETHYLHEXYL METHOXYCINNAMATE CREAM TOPICAL 20101218 UNAPPROVED DRUG OTHER Conju Inc OCTINOXATE; ENZACAMENE; TITANIUM DIOXIDE; AVOBENZONE; ZINC OXIDE .075; .05; .0249; .03; .01 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL E 20171231 59915-5001_7aaa338e-2110-4fbf-8b53-96b75b995f81 59915-5001 HUMAN OTC DRUG Conju Princess tocopherol SOAP TOPICAL 20151225 UNAPPROVED DRUG OTHER Conju Inc TOCOPHEROL 1.1 g/100g E 20171231 59915-5002_2e11ee9d-36d2-518c-e054-00144ff88e88 59915-5002 HUMAN OTC DRUG Conju Princess Cleansing Balm TOCOPHEROL CREAM TOPICAL 20160314 UNAPPROVED DRUG OTHER Conju Inc TOCOPHEROL .0032 g/100g E 20171231 59917-102_8c2a40fe-011c-4f42-8df1-118648b2df39 59917-102 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE EXTENDED RELEASE POTASSIUM CHLORIDE CAPSULE ORAL 20170601 ANDA ANDA208864 Adare Pharmaceuticals Inc POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 59917-103_8c2a40fe-011c-4f42-8df1-118648b2df39 59917-103 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE EXTENDED RELEASE POTASSIUM CHLORIDE CAPSULE ORAL 20170601 ANDA ANDA208864 Adare Pharmaceuticals Inc POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 59922-631_af4d9738-107a-4b4e-9a31-7eb44b5f1a0b 59922-631 HUMAN PRESCRIPTION DRUG Auryxia ferric citrate TABLET, COATED ORAL 20140917 NDA NDA205874 Keryx Biopharmaceuticals, Inc. TETRAFERRIC TRICITRATE DECAHYDRATE 210 mg/1 Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 59923-601_d26cb3e9-ffaa-4080-a643-9482ade04ad7 59923-601 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130806 ANDA ANDA077433 Areva Pharmaceuticals Inc. PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 59923-602_d26cb3e9-ffaa-4080-a643-9482ade04ad7 59923-602 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130806 ANDA ANDA077433 Areva Pharmaceuticals Inc. PAMIDRONATE DISODIUM 6 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 59923-603_d26cb3e9-ffaa-4080-a643-9482ade04ad7 59923-603 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130806 ANDA ANDA077433 Areva Pharmaceuticals Inc. PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 59923-701_71708b53-e2cd-49b3-a06f-2e22ca9ae946 59923-701 HUMAN PRESCRIPTION DRUG EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTION INTRAVENOUS 20140519 ANDA ANDA065361 Areva Pharmaceuticals,Inc. EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 59923-702_b11dc17a-9b4a-4a0e-9831-037ffbcde915 59923-702 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20080220 ANDA ANDA077219 Areva Pharmaceuticals,Inc. IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 59924-001_60be6095-619a-40e4-e053-2a91aa0aea4e 59924-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19460101 NDA NDA205889 Plains Welding Supply, Inc. OXYGEN 992 mL/L N 20181231 59940-001_35aa8a10-6e71-47a5-8018-a66fffc12c34 59940-001 HUMAN OTC DRUG Panitrol XR Menthol CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part348 Enzyme Labs MENTHOL 4.25 g/85g E 20171231 59958-100_0beb6e6e-35df-45d5-b70c-fbb13f131f40 59958-100 HUMAN OTC DRUG Naturally Nova Scotia Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20091210 OTC MONOGRAPH FINAL part333 Owen Biosciences, Inc. ALCOHOL 62 g/100g E 20171231 59958-200_32c111d4-a9c1-4680-9e90-5599747bd1ff 59958-200 HUMAN OTC DRUG Anhydrous SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Owen Biosciences, Inc. TITANIUM DIOXIDE; ZINC OXIDE 10.2; 3.7 g/100g; g/100g E 20171231 59958-200_54a0c38e-0c01-49bb-87e5-983d5aa2790e 59958-200 HUMAN OTC DRUG Anhydrous SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20090901 OTC MONOGRAPH FINAL part352 Owen Biosciences, Inc. TITANIUM DIOXIDE; ZINC OXIDE 10.2; 3.7 g/100g; g/100g E 20171231 59958-200_b8a30ed7-e1b9-4e72-b961-ae00b9502780 59958-200 HUMAN OTC DRUG Anhydrous SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Owen Biosciences, Inc. TITANIUM DIOXIDE; ZINC OXIDE 10.2; 3.7 g/100g; g/100g E 20171231 59958-201_aa382266-b329-415a-8bcc-7d140af6f0ad 59958-201 HUMAN OTC DRUG Dermaroller Anhydrous Sunscreen SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Owen Biosciences, Inc. TITANIUM DIOXIDE; ZINC OXIDE 10.2; 3.7 g/100g; g/100g E 20171231 59958-202_9c3d6f3a-6650-443e-9f6d-e847d3099f7f 59958-202 HUMAN OTC DRUG SFL Sunscreen - SOL Defense SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20120911 OTC MONOGRAPH NOT FINAL part352 Owen Biosciences, Inc. TITANIUM DIOXIDE; ZINC OXIDE 10.2; 3.7 g/100g; g/100g E 20171231 59958-220_25122e72-15f3-4edd-80b0-5946a238bda2 59958-220 HUMAN OTC DRUG Sente Daily Repair Complex SPF 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150402 OTC MONOGRAPH FINAL part352 Owen Biosciences, Inc. TITANIUM DIOXIDE; ZINC OXIDE 9.95; 3.72 g/100g; g/100g E 20171231 59958-230_08cf56a6-ba0c-4c81-b655-271114fc019c 59958-230 HUMAN OTC DRUG Live Ultimate Facial Sunscreen SPF30 SPF 30 Zinc Oxide CREAM TOPICAL 20150505 OTC MONOGRAPH FINAL part352 Owen Biosciences, Inc. ZINC OXIDE 21 g/100g E 20171231 59958-230_71b1f646-8b3f-464c-be73-3305ee6633e8 59958-230 HUMAN OTC DRUG Live Ultimate Facial Sunscreen SPF30 SPF 30 Zinc Oxide CREAM TOPICAL 20150505 OTC MONOGRAPH FINAL part352 Owen Biosciences, Inc. ZINC OXIDE 21 g/100g E 20171231 59958-240_8acc9416-1b90-4627-847b-ced5d68e14b5 59958-240 HUMAN OTC DRUG Skinfuse Shield SPF 30 Zinc Oxide CREAM TOPICAL 20151117 OTC MONOGRAPH FINAL part352 Owen Biosciences, Inc. ZINC OXIDE 21 g/100g E 20171231 59958-240_bb4d608e-3ed8-4b18-9a8e-04382e3577dd 59958-240 HUMAN OTC DRUG Skinfuse Shield SPF 30 Zinc Oxide CREAM TOPICAL 20151111 OTC MONOGRAPH FINAL part352 Owen Biosciences, Inc. ZINC OXIDE 21 g/100g E 20171231 59958-400_f856c43d-0e10-4814-bac8-d48058804148 59958-400 HUMAN OTC DRUG SLMD Acne Cleanser Salicylic Acid GEL TOPICAL 20170322 OTC MONOGRAPH FINAL part333D Owen Biosciences, Inc. SALICYLIC ACID .5 g/100g N 20181231 59958-401_6610b44e-27f8-4f60-904f-afd465369eaf 59958-401 HUMAN OTC DRUG SLMD Spot Treatment Benzoyl Peroxide GEL TOPICAL 20170322 OTC MONOGRAPH FINAL part333D Owen Biosciences, Inc. BENZOYL PEROXIDE 10 g/100g N 20181231 59958-402_ff663370-c4cd-4325-8b49-0689be3c7f0a 59958-402 HUMAN OTC DRUG SLMD AM Benzoyl Peroxide Acne Treatment Benzoyl Peroxide GEL TOPICAL 20170322 OTC MONOGRAPH FINAL part333D Owen Biosciences, Inc. BENZOYL PEROXIDE 2.5 g/100g N 20181231 59958-403_75b7555b-8fc5-4d54-9629-b68e36d75b69 59958-403 HUMAN OTC DRUG SLMD Moisturizer with SPF Sunscreen LOTION TOPICAL 20170405 OTC MONOGRAPH FINAL part352 Owen Biosciences, Inc. OCTINOXATE; OXYBENZONE; AVOBENZONE; OCTISALATE 7.5; 3.5; 2.5; 1.5 g/100g; g/100g; g/100g; g/100g N 20181231 59958-404_74382f04-a36f-4ca4-ae28-a5d6a956a76e 59958-404 HUMAN OTC DRUG Chem Free SPF 30 Zinc Oxide CREAM TOPICAL 20170719 OTC MONOGRAPH FINAL part352 Owen Biosciences, Inc. ZINC OXIDE 21 g/100g N 20181231 59961-123_9377d7c1-23da-404a-9676-f50e148d9521 59961-123 HUMAN OTC DRUG SEA-CALM Meclizine HCl 25mg Chewable Tablets TABLET, CHEWABLE ORAL 20090316 OTC MONOGRAPH FINAL part336 Bellegrove MECLIZINE HYDROCHLORIDE 25 mg/1 E 20171231 59970-040_b93ed0aa-2efa-414c-ad54-64c1a147f53b 59970-040 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20120801 OTC MONOGRAPH FINAL part333B Navarro Discount Pharmacies,LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g E 20171231 59970-041_ecd98043-4c42-4e40-b218-1b53e768ee0b 59970-041 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part348 Navarro Discount Pharmacies,LLC HYDROCORTISONE 1 g/100g E 20171231 59970-042_9760516b-d14e-4b18-abdd-3cfb3acf18d1 59970-042 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part333C Navarro Discount Pharmacies,LLC TOLNAFTATE 1 g/100g E 20171231 59970-043_6acf7e82-8f5c-4747-8fe3-6792b5a51816 59970-043 HUMAN OTC DRUG Muscle and Joint Menthol GEL TOPICAL 20121218 OTC MONOGRAPH NOT FINAL part348 Navarro Discount Pharmacies,LLC MENTHOL 2.5 g/100g E 20171231 59970-044_3fe86fd2-a670-48b0-aa77-568be6234120 59970-044 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20120801 OTC MONOGRAPH FINAL part333B Navarro Discount Pharmacies,LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g E 20171231 59970-045_3c00b93e-8eb0-4ec2-98d4-eb10ccc2a792 59970-045 HUMAN OTC DRUG Diaper Rash Zinc Oxide CREAM TOPICAL 20120713 OTC MONOGRAPH FINAL part347 Navarro Discount Pharmacies,LLC ZINC OXIDE .4 g/g E 20171231 59970-046_bcf6059e-1387-48b8-9776-39cb1e3480d1 59970-046 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part333C Navarro Discount Pharmacies, LLC CLOTRIMAZOLE 1 g/100g E 20171231 59970-048_8df2a8f3-9b55-403e-b1f7-e388e6532dc0 59970-048 HUMAN OTC DRUG Vaporizing Chest Rub Camphor, Eucalyptus Oil, Menthol GEL TOPICAL 20120815 OTC MONOGRAPH FINAL part341 Narvarro Discount Pharmarcies,LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 2.6; 1.2 g/100g; g/100g; g/100g E 20171231 59970-049_1dba961c-c76d-4a7f-8e2d-33f791537982 59970-049 HUMAN OTC DRUG Hemorrhoidal MINERAL OIL,PETROLATUM,PHENYLEPHRINE OINTMENT TOPICAL 20120813 OTC MONOGRAPH FINAL part346 Navarro Discount Pharmacies,LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 71.9; .25 g/100g; g/100g; g/100g E 20171231 59970-050_9e7416f6-23af-4ebb-8788-c1b62db35a3b 59970-050 HUMAN OTC DRUG Redness reliever tetrahydrozoline HCl LIQUID OPHTHALMIC 20120802 OTC MONOGRAPH FINAL part349 Navarro Discount Pharmacies,LLC TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 59970-051_092ea4ba-d369-4bac-ad2d-62dc5507e3ce 59970-051 HUMAN OTC DRUG Tears lubricant glycerin, hypromellose, polyethylene glycol 400 LIQUID OPHTHALMIC 20120813 OTC MONOGRAPH FINAL part349 Navarro Discount Pharmacies,LLC GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL E 20171231 59970-052_e3e0787a-78ad-4215-943c-bee9048dd7e3 59970-052 HUMAN OTC DRUG Nasal Decongestant Oxymetazoline HCl SPRAY NASAL 20121026 OTC MONOGRAPH FINAL part341 Navarro Discount Pharmacies,LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL E 20171231 59970-053_b6158514-9d6b-4d9e-942e-736902f20509 59970-053 HUMAN OTC DRUG Saline Nasal Sodium chloride SPRAY NASAL 20110207 UNAPPROVED DRUG OTHER Navarro Discount Pharmacies, LLC SODIUM CHLORIDE 6.5 mg/mL N 20181231 59970-054_2305ac99-03da-4b70-a09e-0982da1533ac 59970-054 HUMAN OTC DRUG Cold and Hot Pain Relief Menthol PATCH TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part348 Navarro Discount Pharmacies,LLC MENTHOL 400 mg/1 E 20171231 59970-073_9ee4cee1-85fe-4917-90ce-cb5924f8597b 59970-073 HUMAN OTC DRUG Blue Ice Pain Relieving Menthol GEL TOPICAL 20121002 OTC MONOGRAPH NOT FINAL part348 Navarro Discount Pharmacies,LLC MENTHOL .02 g/g E 20171231 59970-074_4bd5270e-9e3a-45a0-9ebb-2953ac12f265 59970-074 HUMAN OTC DRUG Face and Body Sunscreen Octinoxate and Titanium dioxide LOTION TOPICAL 20130124 OTC MONOGRAPH NOT FINAL part352 Navarro Discount Pharmacies,LLC OCTINOXATE; TITANIUM DIOXIDE 7; 2.8 mg/100mg; mg/100mg E 20171231 59970-075_31cda82e-11b2-4537-9f32-f54b01141bb8 59970-075 HUMAN OTC DRUG Calamine zinc oxide, ferric oxide red, pramozine HCl LOTION TOPICAL 20130603 OTC MONOGRAPH FINAL part347 Navarro Discount Pharmacies, LLC ZINC OXIDE; FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE 80; 80; 10 mg/mL; mg/mL; mg/mL N 20181231 59970-076_1ba70839-f441-46ed-90e6-007a5d1606d3 59970-076 HUMAN OTC DRUG Anti-Itch Diphenhydramine HCl GEL TOPICAL 20130118 OTC MONOGRAPH FINAL part336 Navarro Discount Pharmacies,LLC DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100g E 20171231 59970-077_890ed1e7-d20f-4179-97c7-9aea468f623f 59970-077 HUMAN OTC DRUG Day Time Gelcap Acetaminophen, Dextromethorphan, Phenylephrine CAPSULE, LIQUID FILLED ORAL 20130118 OTC MONOGRAPH FINAL part341 Navarro Discount Pharmacies,LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 59970-078_f9c0247e-48e0-40c8-8c96-26b081ade220 59970-078 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20130121 OTC MONOGRAPH FINAL part332 Navarro Discount Pharmacies,LLC DIMETHICONE 125 mg/1 E 20171231 59970-079_6511a44e-9951-42f4-8ef7-8539430a344c 59970-079 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET ORAL 20130201 OTC MONOGRAPH FINAL part338 Navarro Discount Pharmacies,LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 59970-080_fee95a7c-9b47-444d-b232-82d4c4a14f52 59970-080 HUMAN OTC DRUG Cold and Hot Pain Relief Menthol PATCH TOPICAL 20120815 OTC MONOGRAPH NOT FINAL part348 Navarro Discount Pharmacies,LLC MENTHOL 400 mg/1 E 20171231 59970-082_8cc0bed0-b8e4-4124-a592-74d3c104f675 59970-082 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 20130101 OTC MONOGRAPH FINAL part341 Navarro Discount Pharmacies,LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 59970-098_5d8fc726-7deb-0f21-e053-2a91aa0acef7 59970-098 HUMAN OTC DRUG Vida Mia Ear Drops for Swimmers Isopropyl Alcohol LIQUID AURICULAR (OTIC) 20171109 20190228 OTC MONOGRAPH FINAL part344 Navarro Discount Pharmacies, LLC ISOPROPYL ALCOHOL 950 mg/mL N 20181231 59970-105_5d8febce-3f97-0275-e053-2991aa0a58f8 59970-105 HUMAN OTC DRUG Vida Mia Instant Antiseptic Pain Relief Camphor 10.8% and Phenol 4.7% LIQUID TOPICAL 20171109 20180731 OTC MONOGRAPH NOT FINAL part348 Navarro Discount Pharmacies, LLC CAMPHOR (NATURAL); PHENOL 108; 47 mg/mL; mg/mL N 20181231 59970-167_a5d950d3-d3e5-4127-8ab9-50d901e5f705 59970-167 HUMAN OTC DRUG Vida Mia Hand Sanitizer Aloe Vera (62%) ALCOHOL GEL TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 62 mL/100mL E 20171231 59970-168_9756ae95-0ebc-4853-9448-1686f4062f17 59970-168 HUMAN OTC DRUG Vida Mia Hand Sanitizer Aloe Vera (62%) ALCOHOL GEL TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 62 mL/100mL E 20171231 59970-169_49f11c4e-c0b7-4c0d-af37-490f8c2bbd34 59970-169 HUMAN OTC DRUG Vida Mia Hand Sanitizer Aloe Vera (62%) ALCOHOL GEL TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 62 mL/100mL E 20171231 59970-170_6e5deda4-974d-4892-b71b-1022495edee0 59970-170 HUMAN OTC DRUG Vida Mia Hand Sanitizer (62%) ALCOHOL GEL TOPICAL 20140120 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 62 mL/100mL E 20171231 59970-171_4f3bcfd9-0900-422e-a1c2-4d66cf103efa 59970-171 HUMAN OTC DRUG Vida Mia Hand Sanitizer ALCOHOL GEL TOPICAL 20140626 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 62 mL/100mL E 20171231 59970-172_b4817e3b-51c1-45b1-b42a-4bc2aa71bd43 59970-172 HUMAN OTC DRUG Vida Mia Hand Sanitizer (62%) ALCOHOL GEL TOPICAL 20140625 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 62 mL/100mL E 20171231 59970-173_addb1457-1927-4313-a600-52ea778e6008 59970-173 HUMAN OTC DRUG Vida Mia Hand Sanitizer Aloe Vera (70% v/v) ALCOHOL GEL TOPICAL 20131004 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 70 mL/100mL E 20171231 59970-174_bf272411-912a-43f8-a9ed-5246001fb0c5 59970-174 HUMAN OTC DRUG Vida Mia Hand Sanitizer Aloe Vera (70% v/v) ALCOHOL GEL TOPICAL 20131010 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 70 mL/100mL E 20171231 59970-175_6d71a63b-6fb7-4774-ae7d-195bc22ea226 59970-175 HUMAN OTC DRUG Vida Mia Hand Sanitizer Aloe Vera (70% v/v) ALCOHOL GEL TOPICAL 20131014 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 70 mL/100mL E 20171231 59970-176_5afd5507-cd80-436c-b93c-480849097c1f 59970-176 HUMAN OTC DRUG Vida Mia Hand Sanitizer (70% v/v) ALCOHOL GEL TOPICAL 20131014 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 70 mL/100mL E 20171231 59970-177_b1a9dc12-8e3a-4822-bc6d-e60654349f9b 59970-177 HUMAN OTC DRUG Vida Mia Hand Sanitizer (70% v/v) ALCOHOL GEL TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 70 mL/100mL E 20171231 59970-178_e06e52c3-298c-4652-826a-722b1b5bfa27 59970-178 HUMAN OTC DRUG Vida Mia Hand Sanitizer (70% v/v) ALCOHOL GEL TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies,LLC ALCOHOL 70 mL/100mL E 20171231 59970-205_4bf467b5-489b-41b7-8284-291c0cf237ce 59970-205 HUMAN OTC DRUG Vida Mia Pain Relief Aspirin, Citric Acid Monohydrate, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20120813 OTC MONOGRAPH FINAL part343 Navarro Discount Pharmacies, LLC ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 E 20171231 59970-207_5d90b04a-430a-2125-e053-2a91aa0a75ec 59970-207 HUMAN OTC DRUG Vida Mia Decolorized Iodine Ethyl Alcohol LIQUID TOPICAL 20171109 20200131 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies, LLC ALCOHOL .45 mL/mL N 20181231 59970-213_5d68a002-3cc8-b2ce-e053-2991aa0a98c9 59970-213 HUMAN OTC DRUG QC Iodine Tincture Mild Iodine and Sodium Iodide and Alcohol LIQUID TOPICAL 20171109 20200531 OTC MONOGRAPH NOT FINAL part333A Navarro Discount Pharmacies, LLC IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 59970-253_486f7612-526e-14d1-e054-00144ff88e88 59970-253 HUMAN OTC DRUG Vida Mia Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20101028 OTC MONOGRAPH FINAL part358G Navarro Discount Pharmacies, LLC PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 59970-400_5d9038b7-aebc-d148-e053-2991aa0a07f4 59970-400 HUMAN OTC DRUG Vida Mia Calaclear Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 20171109 20200430 OTC MONOGRAPH FINAL part347 Navarro Discount Pharmacies, LLC ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 59970-515_5d90883a-5724-6a0e-e053-2991aa0a3403 59970-515 HUMAN OTC DRUG Vida Mia Castor Oil Castor Oil LIQUID ORAL 20171109 20210228 OTC MONOGRAPH NOT FINAL part334 Navrro Discount Pharmacies, LLC CASTOR OIL 1 mg/mL N 20181231 59970-685_5d91fc56-a555-d003-e053-2a91aa0a2062 59970-685 HUMAN OTC DRUG Vida Mia Sodium Bicarbonate Sodium Bicarbonate POWDER ORAL 20171109 20200430 OTC MONOGRAPH FINAL part331 Navarro Discount Pharmacies, LLC SODIUM BICARBONATE 1000 mg/g N 20181231 59970-749_5d9055dd-91b1-30fd-e053-2a91aa0a8071 59970-749 HUMAN OTC DRUG Vida Mia Merthiolate Benzalkonium Chloride LIQUID TOPICAL 20171109 20180331 OTC MONOGRAPH NOT FINAL part333A Nvarro Discount Pharmacies, LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 59972-0106_5dd99a6e-ba14-4a36-81da-a8b7aac00273 59972-0106 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19921211 UNAPPROVED MEDICAL GAS Hill Country Medical OXYGEN 99 L/100L E 20171231 59973-001_8d1e32c4-dbee-48e9-bc34-4c9934d9f998 59973-001 HUMAN OTC DRUG Nurture Barrier Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Rise Global Products DIMETHICONE 50 mg/mL E 20171231 59973-002_6383b00f-5daa-4c8a-bcc3-78b4fa3a02b7 59973-002 HUMAN OTC DRUG Nurture Skin Protectant Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Rise Global Products DIMETHICONE 10 mg/mL E 20171231 59973-003_6373ace6-8939-47c3-b745-912322bcc3bd 59973-003 HUMAN OTC DRUG Nurture Skin Repair Dimethicone CREAM TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Rise Global Products DIMETHICONE 1.7 mg/118mg E 20171231 59983-001_290ad658-cab4-4f5f-9bbf-01dff064a596 59983-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19790101 NDA NDA205712 Leeper Brothers, Inc. OXYGEN 99 L/100L N 20181231 59985-101_ff2feb54-1609-4504-b536-903748fbc37e 59985-101 HUMAN OTC DRUG Turbo Arnica Cream Arnica montana HPUS CREAM TOPICAL 20141001 UNAPPROVED HOMEOPATHIC Homeopath Ellen's ARNICA MONTANA 30 [hp_C]/28.35g N 20181231 59985-217_562c12bf-6055-46da-bff2-5e2f8e7ba7d6 59985-217 HUMAN OTC DRUG Turbo Travel Sickness Relief Tabacum, HPUS,Cocculus, HPUS,Ipecacuanha, HPUS PELLET ORAL 20140110 UNAPPROVED HOMEOPATHIC Homeopath Ellen's TOBACCO LEAF; JATEORHIZA CALUMBA ROOT; IPECAC 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59985-611_470f24dd-9c60-4831-a998-3e2ef7691fde 59985-611 HUMAN OTC DRUG Family I Kit 30c Homeopathic Kit PELLET ORAL 20151230 UNAPPROVED HOMEOPATHIC Homeopath Ellen's ACONITUM NAPELLUS; ALUMINUM OXIDE; ANTIMONY TRISULFIDE; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; LYTTA VESICATORIA; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; CITRULLUS COLOCYNTHIS FRUIT PULP; DROSERA ROTUNDIFOLIA; EUPHRASIA STRICTA; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IPECAC; POTASSIUM DICHROMATE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIC CHLORIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA PRATENSIS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; DELPHINIUM STAPHISAGRIA SEED; SULFUR; COMFREY ROOT; TOBACCO LEAF; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 59998-101_ca2fc301-535d-4f15-9c5a-8d3a0e2a865f 59998-101 HUMAN OTC DRUG BIOCENCE EUCALYPTOL THYMOL LOTION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part356 Bio-Germ Protection LLC EUCALYPTOL; THYMOL .091; .063 g/100mL; g/100mL N 20181231 59998-102_8d7198e3-2825-4d27-a4d7-f7ea33c8e9e6 59998-102 HUMAN OTC DRUG BIOCENCE EUCALYPTOL THYMOL SPRAY TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part356 Bio-Germ Protection LLC EUCALYPTOL; THYMOL .091; .063 g/100mL; g/100mL N 20181231 59999-001_a7b341ca-a8f5-4539-b5f5-6bfc1b935699 59999-001 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20130923 OTC MONOGRAPH NOT FINAL part343 R3 Pharmaceuticals, LLC ACETAMINOPHEN 160 mg/5mL E 20171231 60000-055_f6577c5b-b4e9-4320-b949-ffe5022153ba 60000-055 HUMAN OTC DRUG Moist Hand Wipes FRESH SCENT Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Ahold U.S.A., Inc. BENZALKONIUM CHLORIDE .115 g/1 N 20181231 60000-056_9ecaa8f3-f57e-4320-8892-013eac00aad8 60000-056 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride SOLUTION ORAL 20150810 OTC MONOGRAPH FINAL part341 Ahold U.S.A., Inc, DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/20mL N 20181231 60000-057_738bbea4-4243-4cbd-980e-a22451b85c4c 60000-057 HUMAN OTC DRUG Mucus Relief DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Ahold U.S.A., Inc, GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 60000-058_e9add770-58e0-4cf3-bbc2-d293ca870b03 60000-058 HUMAN OTC DRUG Mucus Relief DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Ahold U.S.A., Inc, GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 600; 30 mg/1; mg/1 N 20181231 60000-911_43b919a2-487a-4257-9c87-5bf0882bc917 60000-911 HUMAN OTC DRUG PAIN RELIEF PATCHES LIDOCAINE PATCH TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part348 Ahold U.S.A., Inc, LIDOCAINE 4 g/100g N 20181231 60055-334_0b02ccd9-68dd-4c08-bef1-c6bcdd49122a 60055-334 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20101120 ANDA ANDA203920 JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA TRIAD ISOTOPES FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 60055-623_911e0c2c-d159-4bb2-aa54-010ce68cec53 60055-623 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 Sodium Fluoride F 18 INJECTION, SOLUTION INTRAVENOUS 20110126 ANDA ANDA203968 JUBILANT DRAX IMAGE RADIOPHARMACIES, INC. DBA TRIAD ISOTOPES SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 60112-010_5b70690f-3cfe-ebb3-e053-2a91aa0ae6fe 60112-010 HUMAN OTC DRUG Inverness EAR CARE ANTISEPTIC BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333A Inverness Corp BENZALKONIUM CHLORIDE 1.2 mg/mL N 20181231 60193-100_a9d424e9-4891-4035-b3f7-86caffccbf0a 60193-100 HUMAN OTC DRUG Woodwards Mycocide Clinical NS TOLNAFTATE LIQUID TOPICAL 20130424 OTC MONOGRAPH FINAL part333C Pacific World Corporation TOLNAFTATE 10 mg/mL E 20171231 60193-101_dde8e58a-8b52-4404-8238-8c22a21c9daf 60193-101 HUMAN OTC DRUG Dr. Gs Clear Nail TOLNAFTATE LIQUID TOPICAL 20130424 OTC MONOGRAPH FINAL part333C Pacific World Corporation TOLNAFTATE 10 mg/mL E 20171231 60193-102_e078e140-0b97-46e9-99c8-de9c5593a5bb 60193-102 HUMAN OTC DRUG Nailene Antifungal Treatment TOLNAFTATE LIQUID TOPICAL 20130424 OTC MONOGRAPH FINAL part333C Pacific World Corporation TOLNAFTATE 10 mg/mL E 20171231 60193-200_18d11631-4861-4cca-857f-fecfcb9b1a90 60193-200 HUMAN OTC DRUG Woodwards HandClens Foaming Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130603 OTC MONOGRAPH NOT FINAL part333A Pacific World Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 60193-201_42f6ae9c-7567-464a-846b-7c012fcb1a7c 60193-201 HUMAN OTC DRUG Woodwards HandClens Foaming Sanitizer Color and Fragrance Free BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130603 OTC MONOGRAPH NOT FINAL part333A Pacific World Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 60193-202_e11b5c42-e2dc-49bc-b39d-4b8122f8e1ae 60193-202 HUMAN OTC DRUG Woodwards HandClens Foaming Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part333A Pacific World Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 60193-203_338d52ce-d68b-4166-a155-a4c3c4c10a86 60193-203 HUMAN OTC DRUG WOODWARDS HANDCLENS FOAMING SANITIZER COLOR AND FRAGRANCE FREE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part333A Pacific World Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 60193-400_0d3afc45-2982-40b5-ac28-4f616a6cddae 60193-400 HUMAN OTC DRUG Ped X Callus Removers, Medicated Salicylic acid PATCH TOPICAL 20070901 OTC MONOGRAPH FINAL part358F Pacific World Corporation SALICYLIC ACID 4 mg/1 E 20171231 60193-401_0d3afc45-2982-40b5-ac28-4f616a6cddae 60193-401 HUMAN OTC DRUG Ped X Callus Removers, Extra Thick Medicated Salicylic acid PATCH TOPICAL 20070901 OTC MONOGRAPH FINAL part358F Pacific World Corporation SALICYLIC ACID 4 mg/1 E 20171231 60193-402_aae0d494-17f3-45a5-b6e6-01531fd25ade 60193-402 HUMAN OTC DRUG Ped X Corn Removers, Medicated Salicylic acid PATCH TOPICAL 20070901 OTC MONOGRAPH FINAL part358F Pacific World Corporation SALICYLIC ACID 4 mg/1 E 20171231 60193-500_c6fe91e3-7877-4b1e-877c-607decd2da59 60193-500 HUMAN OTC DRUG Trim Men Styptic Pencil Aluminum sulfate STICK TOPICAL 20021101 OTC MONOGRAPH FINAL part347 Pacific World Corporation ALUMINUM SULFATE 5.6 g/10g E 20171231 60193-501_89d1af23-7c8a-4c3d-b009-9715d270e1d1 60193-501 HUMAN OTC DRUG HIS Styptic Pencil Aluminum sulfate STICK TOPICAL 20021101 OTC MONOGRAPH FINAL part347 Pacific World Corporation ALUMINUM SULFATE 5.6 g/10g E 20171231 60207-001_c89ffcbb-ad69-42a5-87c7-eec980be394b 60207-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Apple Homecare Associates, Inc. OXYGEN 99 L/100L E 20171231 60215-110_d7ba3378-4b8d-42ab-8e38-abab72a7418e 60215-110 HUMAN PRESCRIPTION DRUG Choline C 11 Choline C 11 INJECTION INTRAVENOUS 20151029 ANDA ANDA205690 The University of Texas MD Anderson Cancer Center CHOLINE C-11 33.1 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 60215-111_60b1be96-b0e0-42f2-e053-2a91aa0acc61 60215-111 HUMAN PRESCRIPTION DRUG Choline C 11 Choline C 11 INJECTION INTRAVENOUS 20151029 ANDA ANDA205690 The University of Texas MD Anderson Cancer Center CHOLINE C-11 100 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 60215-201_6039da5c-f7d8-2021-e053-2a91aa0a375f 60215-201 HUMAN PRESCRIPTION DRUG Ammonia N 13 Ammonia N-13 INJECTION INTRAVENOUS 20130912 ANDA ANDA203933 The University of Texas MD Anderson Cancer Center AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 60215-411_44e88293-40d9-4f81-8899-cf38774b2a87 60215-411 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20111206 ANDA ANDA203246 The University of Texas MD Anderson Cancer Center FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 60215-412_b358cd7e-9064-423d-a396-216730696795 60215-412 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20111216 ANDA ANDA203247 University of Texas MD Anderson Cancer Center SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 60219-1031_a8d4cd95-140f-4f71-94ef-1c9b68cac6d2 60219-1031 HUMAN PRESCRIPTION DRUG Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20170921 ANDA ANDA207514 Amneal Pharmaceuticals LLC N 20181231 60219-1076_f8f6d1cf-6332-4fdb-b9ce-3e7c3a40b76f 60219-1076 HUMAN PRESCRIPTION DRUG AZATHIOPRINE Azathioprine TABLET ORAL 20150202 ANDA ANDA074069 Amneal Pharmaceuticals LLC AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 60219-1531_d6b4c781-1145-44bb-b5cc-f864b89a2541 60219-1531 HUMAN PRESCRIPTION DRUG levonorgestrel and ethinyl estradiol levonorgestrel and ethinyl estradiol KIT 20160229 ANDA ANDA201108 Amneal Pharmaceuticals LLC N 20181231 60219-1554_357b8574-7bdf-41ad-84e4-25eca693ba1a 60219-1554 HUMAN PRESCRIPTION DRUG levonorgestrel and ethinyl estradiol levonorgestrel and ethinyl estradiol KIT 20160703 ANDA ANDA201095 Amneal Pharmaceuticals LLC N 20181231 60232-0007_05a0fca2-1a48-4d06-81b8-0383c2d9614c 60232-0007 HUMAN OTC DRUG Private Label Moisturizing Oil Free Paraben Free SPF43 Sunscreen LOTION TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part352 Swiss-American CDMO, LLC ZINC OXIDE; OCTINOXATE; OCTISALATE 75; 75; 25 g/1000g; 1/1000g; 1/1000g N 20181231 60232-2269_8e014aa8-deda-4764-8cc2-ed80aaaa8a27 60232-2269 HUMAN OTC DRUG EltaMD UV Daily Tinted Zinc Oxide, Octinoxate Sunscreen LOTION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Swiss American Products ZINC OXIDE; OCTINOXATE 90; 75 g/1000g; g/1000g E 20171231 60232-2277_8dacfb3e-09f9-4278-bc63-e098d8f088e8 60232-2277 HUMAN OTC DRUG EltaMD Laser Balm Petrolatum Skin Protectant OINTMENT TOPICAL 20160906 OTC MONOGRAPH FINAL part347 Swiss-American CDMO, LLC PETROLATUM 77.6 g/1000g E 20171231 60232-2282_f10706a0-bfa2-434e-9b72-00d3e8c94f9b 60232-2282 HUMAN OTC DRUG EltaMD UV Shield SPF 45 Zinc Oxide, Octinoxate LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products OCTINOXATE; ZINC OXIDE 75; 90 g/1000g; g/1000g E 20171231 60232-2283_18401edf-1650-4def-a424-cc1471ad37f6 60232-2283 HUMAN OTC DRUG EltaMD UV Facial SPF 30 Zinc Oxide, Octinoxate LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products OCTINOXATE; ZINC OXIDE 75; 70 g/1000g; g/1000g E 20171231 60232-2286_a0a4b0b2-8179-4781-a248-4665f8ce2288 60232-2286 HUMAN OTC DRUG EltaMD UV SPF 30 Zinc Oxide, Octinoxate LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products OCTINOXATE; ZINC OXIDE 75; 70 g/1000g; g/1000g E 20171231 60232-2289_f95b6205-2e4a-4d52-b2e7-95b6cc238e5a 60232-2289 HUMAN OTC DRUG EltaMD UV Daily SPF 40 Zinc Oxide, Octinoxate LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products OCTINOXATE; ZINC OXIDE 75; 90 g/1000g; g/1000g E 20171231 60232-2290_3cac5881-5e17-47f2-a7f1-439c12e3dab0 60232-2290 HUMAN OTC DRUG EltaMD UV Sport SPF 50 Zinc Oxide, Octinoxate, Octisalate LOTION TOPICAL 20090629 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products ZINC OXIDE; OCTINOXATE; OCTISALATE 90; 75; 50 g/1000g; g/1000g; g/1000g E 20171231 60232-2500_f4b677db-2717-4446-a0f6-4dbcb8e22a6d 60232-2500 HUMAN OTC DRUG Elta MD UV Clear SPF46 zinc oxide and octinoxate lotion LOTION TOPICAL 20090701 OTC MONOGRAPH NOT FINAL part352 Swiss American Products,Inc. ZINC OXIDE; OCTINOXATE 90; 75 g/1000g; g/1000g E 20171231 60232-2510_e874cc96-da2c-4a9a-978e-52ddd9699bc9 60232-2510 HUMAN OTC DRUG EltaMD UV Lip Balm Lip Balm with Sunscreen CREAM TOPICAL 20121127 OTC MONOGRAPH FINAL part352 Swiss American Products ZINC OXIDE; OCTINOXATE 50; 75 g/1000g; g/1000g E 20171231 60232-2512_e1a3ee47-52f9-4a47-b587-89eba2fac794 60232-2512 HUMAN OTC DRUG EltaMD UV Elements physical sunscreen LOTION TOPICAL 20160822 OTC MONOGRAPH NOT FINAL part352 Swiss-American CDMO, LLC ZINC OXIDE; TITANIUM DIOXIDE 10; 5.5 g/1000g; g/1000g E 20171231 60232-2520_92b97d21-4142-45c2-ac1b-87752ba63b40 60232-2520 HUMAN OTC DRUG EltaMD UV Clear Tinted Zinc Oxide, Octinoxate Sunscreen LOTION TOPICAL 20150331 OTC MONOGRAPH NOT FINAL part352 Swiss American Products ZINC OXIDE; OCTINOXATE 90; 75 g/1000g; g/1000g E 20171231 60232-2578_8d61cd67-ec0f-4d7c-958b-8e6bd7d138de 60232-2578 HUMAN OTC DRUG EltaMD UV PhysicalSPF 41 SPF 41 EltaMD UV Physical SPF 41 LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products ZINC OXIDE; TITANIUM DIOXIDE 90; 70 g/1000g; g/1000g E 20171231 60232-2582_9c347a1a-f20c-4a0a-bf70-596614b4bd43 60232-2582 HUMAN OTC DRUG Elta MD UV Pure SPF47 titanium dioxide and zinc oxide lotion LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part352 Swiss American Products, Inc. TITANIUM DIOXIDE; ZINC OXIDE 55; 100 g/1000g; g/1000g E 20171231 60232-2585_79af99c3-2738-494f-9d92-04c8aa606a91 60232-2585 HUMAN OTC DRUG Elta MD UV SPF46 SPF46 zinc oxide and octinoxate sunscreen SPRAY TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 Swiss American Products, Inc. ZINC OXIDE; OCTINOXATE 93; 75 g/1000g; g/1000g E 20171231 60232-2587_a82f310d-4a9d-469f-b5ae-65c8ea0c191c 60232-2587 HUMAN OTC DRUG Elta MD UV Aero SPF45 zinc oxide and octinoxate aerosol AEROSOL, SPRAY TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 Swiss American Products, Inc. ZINC OXIDE; OCTINOXATE 93; 75 g/1000g; g/1000g E 20171231 60232-3400_d3a932f5-339c-442e-b3be-447ec0e89375 60232-3400 HUMAN OTC DRUG Elta Tar Coal Tar CREAM TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part358H Swiss-American Products COAL TAR 20 g/1000g E 20171231 60232-6200_ac940d75-2d95-4235-8746-d75ead219afb 60232-6200 HUMAN OTC DRUG Elta Block SPF 32 Zinc Oxide, Octinoxate, Octisalate LOTION TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products OCTINOXATE; ZINC OXIDE 75; 70 g/1000g; g/1000g E 20171231 60232-7700_6765f72d-4931-4a44-9a65-70f594585178 60232-7700 HUMAN OTC DRUG Elta Lite Tar Coal Tar Lotion LOTION TOPICAL 20110318 OTC MONOGRAPH FINAL part358H Swiss American Products COAL TAR 8 g/1000g E 20171231 60232-8200_41596b93-d71b-4d9b-b72a-f99d09a47418 60232-8200 HUMAN OTC DRUG Elta Seal Zinc Oxide Skin Protectant CREAM TOPICAL 20121201 OTC MONOGRAPH FINAL part347 Swiss American Products ZINC OXIDE 60 g/1000g E 20171231 60232-8577_79102cf1-4999-44a4-b1c8-5acb104f0677 60232-8577 HUMAN OTC DRUG Elta Trivase Miconazole Nitrate CREAM TOPICAL 20020430 OTC MONOGRAPH NOT FINAL part333C Swiss-American Products MICONAZOLE NITRATE 20 g/1000g E 20171231 60232-8581_fadc8e53-03c8-41c0-bc0a-b9549a8b8719 60232-8581 HUMAN OTC DRUG Elta Dermavase Zinc Oxide CREAM TOPICAL 20090630 OTC MONOGRAPH NOT FINAL part352 Swiss-American Products ZINC OXIDE 75 g/1000g E 20171231 60258-005_9625f8fc-b958-4054-9580-826d15156ba5 60258-005 HUMAN PRESCRIPTION DRUG Cytra-K Crystals Potassium Citrate and Citric Acid GRANULE, FOR SOLUTION ORAL 20030501 UNAPPROVED DRUG OTHER Cypress Pharmaceutical, Inc. POTASSIUM CITRATE; CITRIC ACID MONOHYDRATE 3.3; 1.002 g/1; g/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 60258-150_ae70d9a8-5a8b-4a25-8357-0c475a100fef 60258-150 HUMAN PRESCRIPTION DRUG SF 5000 Plus 1.1% Sodium Fluoride Prescription Dental Cream CREAM DENTAL 19991112 UNAPPROVED DRUG OTHER Cypress Pharmaceutical, Inc. SODIUM FLUORIDE 5 mg/g N 20181231 60258-151_58792242-e746-40e6-b549-83cd5f2b7ac5 60258-151 HUMAN PRESCRIPTION DRUG SF 1.1% Sodium Fluoride GEL DENTAL 19991201 UNAPPROVED DRUG OTHER Cypress Pharmaceutical, Inc. SODIUM FLUORIDE 11 mg/g N 20181231 60258-162_5949216e-a012-4a58-b97f-a2333c0a0800 60258-162 HUMAN PRESCRIPTION DRUG Renal Caps Dialysis/Stress Vitamin Supplement ASCORBIC ACID, THIAMINE MONONITRATE,RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CAPSULE, LIQUID FILLED ORAL 20021031 UNAPPROVED DRUG OTHER Cypress Pharmaceutical, Inc. ASCORBIC ACID; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE 100; 1.5; 1.7; 20; 10; 1; 6000; 150000; 5 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20191231 60258-876_686d50e0-dac7-4fb7-b1d9-37574873eab0 60258-876 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl hydrocodone bitartrate, chlorpheniramine maleate, pseudoephedrine hydrochloride SOLUTION ORAL 20140109 NDA NDA022439 Cypress Pharmaceutical, Inc. HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE 5; 60; 4 mg/5mL; mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII N 20181231 60258-951_5e082825-c868-7e60-e053-2991aa0a37a4 60258-951 HUMAN OTC DRUG Senna-S Docusate Sodium and Sennosides TABLET, FILM COATED ORAL 20020503 OTC MONOGRAPH NOT FINAL part334 Cypress Pharmaceutical, Inc. DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 60267-311_95ff0775-a09d-4cdb-83d9-4f86d9ac45d9 60267-311 HUMAN PRESCRIPTION DRUG Sodium Nitrite Sodium Nitrite INJECTION, SOLUTION INTRAVENOUS 20120214 NDA NDA203922 Hope Pharmaceuticals SODIUM NITRITE 30 mg/mL N 20181231 60267-705_efdf4b7b-ec7a-4dc9-b743-2e59b442d42d 60267-705 HUMAN PRESCRIPTION DRUG Sodium Thiosulfate Sodium Thiosulfate INJECTION, SOLUTION INTRAVENOUS 20120214 NDA NDA203923 Hope Pharmaceuticals SODIUM THIOSULFATE 250 mg/mL N 20181231 60267-812_f2a801dc-fc23-46b2-883b-755c2d0f635c 60267-812 HUMAN PRESCRIPTION DRUG NITHIODOTE Sodium Nitrite and Sodium Thiosulfate KIT 20110114 NDA NDA201444 Hope Pharmaceuticals N 20181231 60268-0001_cf5df580-de27-4b55-b881-40d2ae223978 60268-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990601 UNAPPROVED MEDICAL GAS Gammie Home Care, Inc. OXYGEN 99 L/100L E 20171231 60289-015_65180c92-644f-4bbc-b2cc-d790c84410f9 60289-015 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 15 OCTOCRYLENE SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 AHAVA - Dead Sea Laboratories Ltd. OCTOCRYLENE; ENSULIZOLE; OCTISALATE; AVOBENZONE; TITANIUM DIOXIDE 20; 2.5; 7.5; 6.25; 3.14 mL/250mL; mL/250mL; mL/250mL; mL/250mL; mL/250mL N 20181231 60289-030_5793e66f-b21b-45ac-ba77-43d1ddb45acf 60289-030 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 30 OCTOCRYLENE SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 AHAVA - Dead Sea Laboratories Ltd. OCTOCRYLENE; ENSULIZOLE; OCTISALATE; AVOBENZONE; TITANIUM DIOXIDE 25; 2.5; 5; 7.5; 3.8 mL/250mL; mL/250mL; mL/250mL; mL/250mL; mL/250mL N 20181231 60289-031_826a5dcf-25d7-4bc0-8565-d90f97805be4 60289-031 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 30 OCTOCRYLENE CREAM TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 AHAVA - Dead Sea Laboratories Ltd. OCTOCRYLENE; ENSULIZOLE; OCTISALATE; AVOBENZONE; TITANIUM DIOXIDE 25; 2.5; 5; 7.5; 3.8 mL/250mL; mL/250mL; mL/250mL; mL/250mL; mL/250mL N 20181231 60289-050_dd4b7f02-04d9-47da-8145-b41440ca0978 60289-050 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 50 OCTOCRYLENE CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 AHAVA - Dead Sea Laboratories Ltd. OCTOCRYLENE; ENSULIZOLE; OCTISALATE; AVOBENZONE; TITANIUM DIOXIDE 25; 2.5; 12.5; 7.5; 12.5 mL/250mL; mL/250mL; mL/250mL; mL/250mL; mL/250mL N 20181231 60289-051_450aeec9-2408-42fc-8929-05ae5825e066 60289-051 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS Mineral Suncare spf 50 face OCTOCRYLENE CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 AHAVA - Dead Sea Laboratories Ltd. OCTOCRYLENE; ENSULIZOLE; OCTISALATE; AVOBENZONE; TITANIUM DIOXIDE 6; .6; 3; 1.8; 3 mL/60mL; mL/60mL; mL/60mL; mL/60mL; mL/60mL N 20181231 60289-236_d2430dc8-4588-4f6b-825f-acc071827f01 60289-236 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS TIME TO HYDRATE ESSENTIAL MOISTURIZING BROAD SPECTRUM SPF15 Avobenzone, Octisalate, and Octocrylene LOTION TOPICAL 20130201 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 2.5; 1.355 g/50mL; g/50mL; g/50mL N 20181231 60289-238_cabe05ad-aba3-417c-b3fc-59fbe788f907 60289-238 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS TIME TO HYDRATE ESSENTIAL LIP BALM BROAD SPECTRUM SPF15 Avobenzone, Octisalate, and Octocrylene CREAM TOPICAL 20130808 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE .45; .75; .411 g/15mL; g/15mL; g/15mL E 20171231 60289-247_70686933-1631-4e9d-b879-85a5d49b9dd1 60289-247 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS AGE CONTROL EVEN TONE MOISTURIZER BROAD SPECTRUM SPF20 Avobenzone, Octisalate, Homosalate, and Octocrylene CREAM TOPICAL 20130201 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 1.5; 2.5; 2.5; 1.35 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 60289-280_59891430-d832-479d-879e-2d9fb932cb7d 60289-280 HUMAN OTC DRUG AHAVA AGE PERFECTING BROAD SPECTRUM SPF15 Avobenzone, Octisalate, and Octocrylene CREAM TOPICAL 20131115 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 2.25; 3.75; 2.05 g/75mL; g/75mL; g/75mL E 20171231 60289-281_643d2289-d701-4710-bbc4-f39a13a92c85 60289-281 HUMAN OTC DRUG AHAVA AGE PERFECTING BROAD SPECTRUM SPF15 Avobenzone, Octisalate, and Octocrylene CREAM TOPICAL 20131115 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 2.25; 3.75; 2.05 g/75mL; g/75mL; g/75mL N 20181231 60289-282_3185c69d-9b09-42b8-9dcc-57206a8cbc1d 60289-282 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15 Avobenzone, Octisalate, and Octocrylene CREAM TOPICAL 20130725 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; OCTISALATE; OCTOCRYLENE 30; 50; 27 mg/mL; mg/mL; mg/mL N 20181231 60289-283_32c9d757-209e-449b-9ce0-d5efe69ca0c5 60289-283 HUMAN OTC DRUG BEAUTY BEFORE AGE AHAVA UPLIFT DAY broad spectrum SPF 20 Homosalate, Octisalate, and Avobenzone CREAM TOPICAL 20150515 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd HOMOSALATE; OCTISALATE; AVOBENZONE 3.5; 2.5; 1.5 g/50mL; g/50mL; g/50mL N 20181231 60289-284_3c9bfba6-62e4-4201-a766-bd5e51a547a5 60289-284 HUMAN OTC DRUG Mineral Radiance Energizing Day BS SPF 15 Avobenzone, Homosalate, and Octisalate CREAM TOPICAL 20161115 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; HOMOSALATE; OCTISALATE 30; 70; 50 mg/mL; mg/mL; mg/mL N 20181231 60289-347_f206a473-2787-4da3-bb44-cf5ee8503e6c 60289-347 HUMAN OTC DRUG AHAVA ACTIVE DEADSEA MINERALS AHAVA Age Control Even Tone Moisturizer Broad Spectrum SPF 20 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20130102 OTC MONOGRAPH FINAL part352 AHAVA Dead Sea Laboratories Ltd AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 70; 50; 27 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 60306-115_390a5e15-64db-4873-b109-bc584f243923 60306-115 HUMAN OTC DRUG Brace Relief Benzocaine GEL ORAL 20050103 OTC MONOGRAPH FINAL part333B InfaLab,Inc BENZOCAINE 9 mg/mL E 20171231 60314-1001_e21b68b7-9644-4c60-ae03-5171422215b4 60314-1001 HUMAN OTC DRUG Slim 2 CIANIDANOL POWDER ORAL 20110915 UNAPPROVED DRUG OTHER Bionutrigen Co., Ltd. CIANIDANOL .45 g/100g E 20171231 60314-2001_33a79df4-2309-4dc2-bee5-f12d8b9d3d38 60314-2001 HUMAN OTC DRUG Liver supplement PHENOL POWDER ORAL 20110915 UNAPPROVED DRUG OTHER Bionutrigen Co., Ltd. PHENOL .8 g/100g E 20171231 60317-123_6bd7c19e-73cc-7905-3fc8-cac5a42c8fec 60317-123 HUMAN PRESCRIPTION DRUG Liquid Oxygen Liquid Oxygen GAS RESPIRATORY (INHALATION) 19900810 UNAPPROVED MEDICAL GAS Pedi Stat Inc. OXYGEN 995 mL/L E 20171231 60319-1001_95ed2181-d9d7-42cc-9658-660ff7a91d19 60319-1001 HUMAN OTC DRUG Premium Whitening HYDROGEN PEROXIDE GEL, DENTIFRICE DENTAL 20110913 UNAPPROVED DRUG OTHER Hankuk Bowonbio Co., Ltd HYDROGEN PEROXIDE 35 mL/100mL N 20181231 60319-2001_0c6bafe0-d8b1-4266-9d0a-51a4f48944dc 60319-2001 HUMAN OTC DRUG Noble S Plus SILVER PASTE, DENTIFRICE DENTAL 20110919 UNAPPROVED DRUG OTHER Hankuk Bowonbio Co., Ltd SILVER .7 g/100g N 20181231 60319-3001_54d953fc-a218-4108-8119-5fc5a18aa5f9 60319-3001 HUMAN OTC DRUG Noble G Plus XYLITOL PASTE, DENTIFRICE DENTAL 20121130 UNAPPROVED DRUG OTHER Hankuk Bowonbio Co., Ltd XYLITOL .7 g/100g N 20181231 60319-4001_249601f7-e1e1-48dd-9ce4-6d9f1310151b 60319-4001 HUMAN OTC DRUG Noble 1 Plus XYLITOL POWDER, DENTIFRICE DENTAL 20121130 UNAPPROVED DRUG OTHER Hankuk Bowonbio Co., Ltd XYLITOL .7 g/100g N 20181231 60319-5001_ef6c1168-9a69-4b57-a8bf-5e228c48d9bd 60319-5001 HUMAN OTC DRUG Tooth Whole White HYDROGEN PEROXIDE PASTE, DENTIFRICE DENTAL 20151220 UNAPPROVED DRUG OTHER Hankuk Bowonbio Co., Ltd HYDROGEN PEROXIDE 2.14 g/100g N 20181231 60344-1001_a37f95b0-a39d-423b-9fdd-e4f41892bd0f 60344-1001 HUMAN OTC DRUG TAMNAMO ESSENTIAL HAIR GLYCERIN SHAMPOO TOPICAL 20130826 OTC MONOGRAPH FINAL part347 Tamnamo Co., Ltd GLYCERIN .04 g/mL N 20181231 60344-2001_7b8786b3-ddb7-4f0b-9939-2f10fb323844 60344-2001 HUMAN OTC DRUG TAMNAMO PLUS VITAL HAIR GLYCERIN SHAMPOO TOPICAL 20130826 OTC MONOGRAPH FINAL part347 Tamnamo Co., Ltd GLYCERIN .01 g/mL N 20181231 60344-3001_3d1f1e51-fa18-40de-a890-9aa093d104f0 60344-3001 HUMAN OTC DRUG TAMNAMO ESSENTIAL HAIR TONIC ASIAN GINSENG LIQUID TOPICAL 20130812 UNAPPROVED DRUG OTHER Tamnamo Co., Ltd ASIAN GINSENG .03 mg/mL N 20181231 60344-4001_edf62bec-8450-44cc-a21d-f3bf7d41da86 60344-4001 HUMAN OTC DRUG TAMNAMO PLUS VITAL HAIR ASIAN GINSENG SOLUTION TOPICAL 20130812 UNAPPROVED DRUG OTHER Tamnamo Co., Ltd ASIAN GINSENG .03 mg/mL N 20181231 60344-5001_b6f3309b-49e0-474d-86ef-2be8cbd341ea 60344-5001 HUMAN OTC DRUG Queen Perfume Hair GLYCERIN SHAMPOO TOPICAL 20140130 OTC MONOGRAPH FINAL part347 Tamnamo Co., Ltd GLYCERIN .02 mg/mL N 20181231 60344-6001_ca52cb6a-4b3f-4b34-965d-36e7b3efd12d 60344-6001 HUMAN OTC DRUG Queen Perfume Hair Conditioner ALLANTOIN LIQUID TOPICAL 20140130 OTC MONOGRAPH FINAL part347 Tamnamo Co., Ltd ALLANTOIN .02 mg/mL N 20181231 60344-7001_606fe294-7d5c-4cce-965e-7cbbda19fae9 60344-7001 HUMAN OTC DRUG Tamnamo Vital Hair Treatment ALLANTOIN LIQUID TOPICAL 20140130 OTC MONOGRAPH FINAL part347 Tamnamo Co., Ltd ALLANTOIN .002 g/mL N 20181231 60367-001_c49ffe21-92e7-4fad-ab14-f562eb18ed76 60367-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19750101 UNAPPROVED MEDICAL GAS County Welding Supply Co. OXYGEN 998 mL/L E 20171231 60367-002_61428735-f699-b774-e053-2a91aa0a1f11 60367-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19750101 NDA NDA205767 County Welding Supply Co. OXYGEN 998 mL/L N 20181231 60371-339_94f4ab8d-8b5b-47da-8457-b0c2e7206489 60371-339 HUMAN OTC DRUG SafetyMAXX Mint Flavor SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20111115 OTC MONOGRAPH FINAL part355 FSi, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 60371-344_11fc8a8a-b455-4c65-978a-914282ee1993 60371-344 HUMAN OTC DRUG SafetyMAXX Mint Flavor SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20111115 OTC MONOGRAPH FINAL part355 FSi, Inc. SODIUM FLUORIDE .22 g/100g E 20171231 60379-100_602d10fc-10fc-c1dd-e053-2a91aa0a675e 60379-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20070601 UNAPPROVED MEDICAL GAS Providence Home Medical Equipment OXYGEN 1 L/L N 20181231 60429-012_13551e0d-9364-4aa2-9a2b-1f58dbb8688b 60429-012 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20130927 ANDA ANDA075677 Golden State Medical Supply, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60429-016_05fcef0b-f301-47f3-a14c-3bdb4e6d3d18 60429-016 HUMAN PRESCRIPTION DRUG Mycophenolic Acid Mycophenolic Acid TABLET, DELAYED RELEASE ORAL 20141013 ANDA ANDA091558 Golden State Medical Supply, Inc. MYCOPHENOLATE SODIUM 180 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 60429-017_05fcef0b-f301-47f3-a14c-3bdb4e6d3d18 60429-017 HUMAN PRESCRIPTION DRUG Mycophenolic Acid Mycophenolic Acid TABLET, DELAYED RELEASE ORAL 20141013 ANDA ANDA091558 Golden State Medical Supply, Inc. MYCOPHENOLATE SODIUM 360 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 60429-018_72d229be-8141-4f04-9bcc-f1cb5226f26b 60429-018 HUMAN PRESCRIPTION DRUG Benzonatate benzonatate CAPSULE ORAL 20070725 20180630 ANDA ANDA040627 Golden State Medical Supply, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 60429-019_f17d42f6-ec31-4e0b-b255-39930865ab5f 60429-019 HUMAN PRESCRIPTION DRUG SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE CAPSULE ORAL 20111213 ANDA ANDA075352 Golden State Medical Supply, Inc. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 60429-020_a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7 60429-020 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 20090520 ANDA ANDA075319 Golden State Medical Supply, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 60429-021_401b325f-f844-42b1-af8b-d260af12328d 60429-021 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20090715 ANDA ANDA062884 Golden State Medical Supply, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 60429-022_401b325f-f844-42b1-af8b-d260af12328d 60429-022 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20090715 ANDA ANDA062881 Golden State Medical Supply, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 60429-025_a306b11d-0d39-4efc-a596-50a061545bc1 60429-025 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20140220 ANDA ANDA073457 Golden State Medical Supply, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60429-026_a306b11d-0d39-4efc-a596-50a061545bc1 60429-026 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20140220 ANDA ANDA073457 Golden State Medical Supply, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60429-027_a306b11d-0d39-4efc-a596-50a061545bc1 60429-027 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20140220 ANDA ANDA073457 Golden State Medical Supply, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60429-028_72d229be-8141-4f04-9bcc-f1cb5226f26b 60429-028 HUMAN PRESCRIPTION DRUG Benzonatate benzonatate CAPSULE ORAL 20070725 20180228 ANDA ANDA040749 Golden State Medical Supply, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 60429-032_664a6a49-1ed2-4eae-a12b-8d46f744caba 60429-032 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20140307 ANDA ANDA075948 Golden State Medical Supply, Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 60429-033_0d806bbe-d2b5-4ef1-ade8-2a92f8cf1d03 60429-033 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 20110809 ANDA ANDA040195 Golden State Medical Supply, Inc. ACETAZOLAMIDE 125 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 60429-034_0d806bbe-d2b5-4ef1-ade8-2a92f8cf1d03 60429-034 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 20110809 ANDA ANDA040195 Golden State Medical Supply, Inc. ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 60429-035_80ccd4e3-6d2b-4c02-acc3-78f89e64487e 60429-035 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET ORAL 20140508 ANDA ANDA204476 Golden State Medical Supply, Inc. PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] N 20181231 60429-042_0dd6437b-7370-4313-b8fa-1e50d242ed08 60429-042 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20141103 ANDA ANDA076558 Golden State Medical Supply, Inc CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 60429-052_f7e6fd6a-70d8-4b95-bff0-e45a7e8022e7 60429-052 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20120329 ANDA ANDA071611 Golden State Medical Supply, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 60429-055_b92b51d0-54e1-40e1-ad4a-7c769a8f6175 60429-055 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20140403 ANDA ANDA090258 Golden State Medical Supply, Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 60429-056_b92b51d0-54e1-40e1-ad4a-7c769a8f6175 60429-056 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20140403 ANDA ANDA090258 Golden State Medical Supply, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 60429-057_7a7e69c1-6eea-4f27-b2ed-3e5fb176fdae 60429-057 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20140812 ANDA ANDA075185 Golden State Medical Supply, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-058_7a7e69c1-6eea-4f27-b2ed-3e5fb176fdae 60429-058 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20140812 ANDA ANDA075185 Golden State Medical Supply, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-059_f17c22a2-c988-4d8c-b8a7-4e53df743b24 60429-059 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil CAPSULE ORAL 20150106 ANDA ANDA065520 Golden State Medical Supply, Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 60429-061_88d04e4b-d93f-4711-bac6-fbeb952d1a6b 60429-061 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20130411 ANDA ANDA078069 Golden State Medical Supply OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60429-062_88d04e4b-d93f-4711-bac6-fbeb952d1a6b 60429-062 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20130411 ANDA ANDA078069 Golden State Medical Supply OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60429-063_88d04e4b-d93f-4711-bac6-fbeb952d1a6b 60429-063 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20130411 ANDA ANDA078069 Golden State Medical Supply OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60429-069_d17635e2-d610-40ac-b872-5b71382a0a2a 60429-069 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20160601 ANDA ANDA065095 Golden State Medical Supply, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 60429-070_f17c22a2-c988-4d8c-b8a7-4e53df743b24 60429-070 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil mycophenolate mofetil TABLET, FILM COATED ORAL 20150106 ANDA ANDA065521 Golden State Medical Supply, Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 60429-081_ae8a6c8f-c1f7-47bb-b1ed-497ab7ed0e57 60429-081 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19930927 ANDA ANDA074270 Golden State Medical Supply, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 60429-085_682658f2-2f51-4ba8-a5d8-6f9a48e394a4 60429-085 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 Golden State Medical Supply, Inc PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60429-086_682658f2-2f51-4ba8-a5d8-6f9a48e394a4 60429-086 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 Golden State Medical Supply, Inc PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60429-087_682658f2-2f51-4ba8-a5d8-6f9a48e394a4 60429-087 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 Golden State Medical Supply, Inc PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60429-089_682658f2-2f51-4ba8-a5d8-6f9a48e394a4 60429-089 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 Golden State Medical Supply, Inc PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60429-090_682658f2-2f51-4ba8-a5d8-6f9a48e394a4 60429-090 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20141029 ANDA ANDA203855 Golden State Medical Supply, Inc PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60429-092_637c272d-2adc-4f9e-aed2-2a0845a25a14 60429-092 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Golden State Medical Supply, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-093_637c272d-2adc-4f9e-aed2-2a0845a25a14 60429-093 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Golden State Medical Supply, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-094_637c272d-2adc-4f9e-aed2-2a0845a25a14 60429-094 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Golden State Medical Supply, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-095_627e6f8b-6056-42de-a279-98cc045bec96 60429-095 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19990827 ANDA ANDA088292 Golden State Medical Supply, Inc. IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 60429-096_627e6f8b-6056-42de-a279-98cc045bec96 60429-096 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19990827 ANDA ANDA088262 Golden State Medical Supply, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 60429-097_627e6f8b-6056-42de-a279-98cc045bec96 60429-097 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19990827 ANDA ANDA088276 Golden State Medical Supply, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 60429-098_df1f759d-a248-44ee-a26d-b04d8fb8e690 60429-098 HUMAN PRESCRIPTION DRUG Trospium Chloride Trospium Chloride CAPSULE, EXTENDED RELEASE ORAL 20140718 ANDA ANDA091289 Golden State Medical Supply, Inc. TROSPIUM CHLORIDE 60 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 60429-101_8020edd0-b9e6-428c-a534-fb8f780fbdf1 60429-101 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19871026 ANDA ANDA086066 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 10 mg/1 E 20171231 60429-102_8020edd0-b9e6-428c-a534-fb8f780fbdf1 60429-102 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19871102 ANDA ANDA088088 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 20 mg/1 E 20171231 60429-103_0ac65eae-b3dd-4cda-aec2-ff1e954a93a4 60429-103 HUMAN PRESCRIPTION DRUG TROSPIUM CHLORIDE TROSPIUM CHLORIDE TABLET ORAL 20130208 ANDA ANDA091513 Golden State Medical Supply, Inc. TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 60429-104_8020edd0-b9e6-428c-a534-fb8f780fbdf1 60429-104 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 19871026 ANDA ANDA086067 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 5 mg/1 E 20171231 60429-105_a6e62b96-554b-4bb9-a172-2640f7f98905 60429-105 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20130208 ANDA ANDA077706 Golden State Medical Supply, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 60429-106_aac2e72d-f787-4db4-b944-78589a5e972b 60429-106 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20131018 ANDA ANDA078801 Golden State Medical Supply, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 60429-107_8020edd0-b9e6-428c-a534-fb8f780fbdf1 60429-107 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 20070110 ANDA ANDA040591 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 30 mg/1 E 20171231 60429-108_8020edd0-b9e6-428c-a534-fb8f780fbdf1 60429-108 HUMAN PRESCRIPTION DRUG Isosorbide Sublingual Isosorbide Dinitrate TABLET SUBLINGUAL 19781201 ANDA ANDA086054 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 2.5 mg/1 E 20171231 60429-109_8020edd0-b9e6-428c-a534-fb8f780fbdf1 60429-109 HUMAN PRESCRIPTION DRUG Isosorbide Sublingual Isosorbide Dinitrate TABLET SUBLINGUAL 19871102 ANDA ANDA086055 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 5 mg/1 E 20171231 60429-111_c52d1cac-9da8-42e0-857d-724049ae2b11 60429-111 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20131023 ANDA ANDA203769 Golden State Medical Supply, Inc METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60429-112_c52d1cac-9da8-42e0-857d-724049ae2b11 60429-112 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20131023 ANDA ANDA203769 Golden State Medical Supply, Inc METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60429-113_c52d1cac-9da8-42e0-857d-724049ae2b11 60429-113 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20131023 ANDA ANDA203769 Golden State Medical Supply, Inc METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60429-114_1612d834-229b-499e-9680-b41d0675ebaf 60429-114 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride Dorzolamide Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20141113 ANDA ANDA077846 Golden State Medical Supply, Inc. DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] N 20181231 60429-115_d2dc8ea7-7afa-4127-ad06-63970996b87b 60429-115 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20141113 ANDA ANDA077847 Golden State Medical Supply, Inc. DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60429-118_a3d0b854-e617-4621-af12-e3c7169b107a 60429-118 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20140220 ANDA ANDA200958 Golden State Medical Supply, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 60429-119_a3d0b854-e617-4621-af12-e3c7169b107a 60429-119 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20140220 ANDA ANDA200958 Golden State Medical Supply, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 60429-121_c8d227ff-296e-4485-b4d5-3cb3c1903062 60429-121 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130612 ANDA ANDA090174 Golden State Medical Supply, Inc VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 60429-122_c8d227ff-296e-4485-b4d5-3cb3c1903062 60429-122 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130612 ANDA ANDA090174 Golden State Medical Supply, Inc VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 60429-123_c8d227ff-296e-4485-b4d5-3cb3c1903062 60429-123 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130612 ANDA ANDA090174 Golden State Medical Supply, Inc VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 60429-124_6b132a90-aa9d-4e3a-86d8-5306fb824955 60429-124 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 20140422 20180930 ANDA ANDA074673 Golden State Medical Supply, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60429-126_2502fda2-3813-41f3-a720-62f40a4d50db 60429-126 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140715 ANDA ANDA078494 Golden State Medical Supply, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60429-127_2502fda2-3813-41f3-a720-62f40a4d50db 60429-127 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140715 ANDA ANDA078494 Golden State Medical Supply, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60429-128_2502fda2-3813-41f3-a720-62f40a4d50db 60429-128 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140715 ANDA ANDA078494 Golden State Medical Supply, Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60429-129_2502fda2-3813-41f3-a720-62f40a4d50db 60429-129 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140715 ANDA ANDA078494 Golden State Medical Supply, Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60429-130_0dd606ff-3628-4d3d-9f41-ec323fd9ed54 60429-130 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA080292 Golden State Medical Supply, Inc. PREDNISONE 5 mg/1 E 20171231 60429-131_0dd606ff-3628-4d3d-9f41-ec323fd9ed54 60429-131 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA088832 Golden State Medical Supply, Inc. PREDNISONE 10 mg/1 E 20171231 60429-132_0dd606ff-3628-4d3d-9f41-ec323fd9ed54 60429-132 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 Golden State Medical Supply, Inc. PREDNISONE 20 mg/1 E 20171231 60429-138_47c8a7d7-6656-4c4e-a0f8-5ebc4e78a21f 60429-138 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20120516 ANDA ANDA075517 Golden State Medical Supply, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 60429-139_2bd4fe90-419c-48ce-abcb-71d9c6ec0b9b 60429-139 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20130322 ANDA ANDA077118 Golden State Medical Supply, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 60429-140_2bd4fe90-419c-48ce-abcb-71d9c6ec0b9b 60429-140 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20130322 ANDA ANDA076862 Golden State Medical Supply, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 60429-141_18bc10e3-2c4c-4519-b584-335ebbbb147d 60429-141 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Golden State Medical Supply, Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 60429-142_18bc10e3-2c4c-4519-b584-335ebbbb147d 60429-142 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Golden State Medical Supply, Inc. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 60429-146_d1035cf9-d687-48df-ac03-aa00ef06618c 60429-146 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE, LIQUID FILLED ORAL 20080321 ANDA ANDA076740 Golden State Medical Supply, Inc. NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60429-147_a6dd3346-3f49-4592-b5ce-58d671e814a1 60429-147 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20111229 ANDA ANDA062936 Golden State Medical Supply, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 60429-148_a6dd3346-3f49-4592-b5ce-58d671e814a1 60429-148 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 19960709 ANDA ANDA062935 Golden State Medical Supply, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 60429-149_52a2ff7c-84ef-4ce5-ad8f-73f1bd9ed267 60429-149 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20111121 ANDA ANDA040712 Golden State Medical Supply, Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 60429-150_52a2ff7c-84ef-4ce5-ad8f-73f1bd9ed267 60429-150 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20111121 ANDA ANDA040712 Golden State Medical Supply, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 60429-151_52a2ff7c-84ef-4ce5-ad8f-73f1bd9ed267 60429-151 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20111121 ANDA ANDA040713 Golden State Medical Supply, Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 60429-152_15e7734e-6f60-47f7-8b5c-86db15330d9e 60429-152 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20131018 ANDA ANDA074260 Golden State Medical Supply, Inc. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 60429-153_15e7734e-6f60-47f7-8b5c-86db15330d9e 60429-153 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20131018 ANDA ANDA074260 Golden State Medical Supply, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 60429-154_15e7734e-6f60-47f7-8b5c-86db15330d9e 60429-154 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20131018 ANDA ANDA074260 Golden State Medical Supply, Inc. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 60429-155_21408a33-8c32-48bf-b2cf-73c830abfe9a 60429-155 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride CAPSULE ORAL 19961001 ANDA ANDA040161 Golden State Medical Supply, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 60429-156_21408a33-8c32-48bf-b2cf-73c830abfe9a 60429-156 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 Golden State Medical Supply, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 60429-158_118b23a8-99d8-4c31-8058-c4b505ff6426 60429-158 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20140715 ANDA ANDA076402 Golden State Medical Supply, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60429-159_118b23a8-99d8-4c31-8058-c4b505ff6426 60429-159 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20140715 ANDA ANDA076402 Golden State Medical Supply, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60429-160_118b23a8-99d8-4c31-8058-c4b505ff6426 60429-160 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20140715 ANDA ANDA076402 Golden State Medical Supply, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60429-162_e3ccebb4-a76e-4405-9ea2-cf66505b3336 60429-162 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20140212 ANDA ANDA062505 Golden State Medical Supply, Inc. DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 60429-163_2d934d80-6d28-415d-8963-bf8d1e4b038c 60429-163 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20090811 ANDA ANDA072781 Golden State Medical Supply, Inc. NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60429-164_07cd1b2e-e3b6-44c3-b78c-4e721c066399 60429-164 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Golden State Medical Supply, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60429-165_07cd1b2e-e3b6-44c3-b78c-4e721c066399 60429-165 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Golden State Medical Supply, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60429-166_07cd1b2e-e3b6-44c3-b78c-4e721c066399 60429-166 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Golden State Medical Supply, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60429-171_19dde540-3d29-4db4-9570-6ca15f09e0fe 60429-171 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20100125 ANDA ANDA072710 Golden State Medical Supply, Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-172_19dde540-3d29-4db4-9570-6ca15f09e0fe 60429-172 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 20100125 ANDA ANDA072711 Golden State Medical Supply, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-173_f3a26d92-b662-4896-82eb-261948042408 60429-173 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110520 ANDA ANDA077045 Golden State Medical Supply, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 60429-174_f3a26d92-b662-4896-82eb-261948042408 60429-174 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110520 ANDA ANDA077045 Golden State Medical Supply, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 60429-175_f3a26d92-b662-4896-82eb-261948042408 60429-175 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110520 ANDA ANDA077045 Golden State Medical Supply, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 60429-176_7cd4e31b-0757-46da-b00b-245e83319db6 60429-176 HUMAN PRESCRIPTION DRUG Selegiline Hydrochloride Selegiline Hydrochloride TABLET ORAL 20130402 ANDA ANDA074871 Golden State Medical Supply, Inc. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 60429-177_169773f2-99c2-4d3a-8ae7-ef3d794883ea 60429-177 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20140508 ANDA ANDA078917 Golden State Medical Supply, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 60429-180_f254fc9a-0740-4a31-82be-6405cbd6cda6 60429-180 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20150209 ANDA ANDA071586 Golden State Medical Supply, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 60429-181_f254fc9a-0740-4a31-82be-6405cbd6cda6 60429-181 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20150209 ANDA ANDA071587 Golden State Medical Supply, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 60429-182_3b4f5066-f8df-4ca6-b0fe-7be218f04be6 60429-182 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150106 ANDA ANDA076048 Golden State Medical Supply, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60429-183_4cfda75d-c080-452d-8137-5b84182aef22 60429-183 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20131104 ANDA ANDA075657 Golden State Medical Supply, Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60429-184_4cfda75d-c080-452d-8137-5b84182aef22 60429-184 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20131104 ANDA ANDA075657 Golden State Medical Supply, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60429-185_4cfda75d-c080-452d-8137-5b84182aef22 60429-185 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20131104 ANDA ANDA075657 Golden State Medical Supply, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60429-186_4cfda75d-c080-452d-8137-5b84182aef22 60429-186 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20131104 ANDA ANDA075657 Golden State Medical Supply, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60429-187_2d082996-ff62-4e65-a4b1-191520238c6a 60429-187 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071258 Golden State Medical Supply, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 60429-188_2d082996-ff62-4e65-a4b1-191520238c6a 60429-188 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Golden State Medical Supply, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 60429-190_0bec7a9e-a2ad-438f-a8e2-fadd552ba009 60429-190 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20150113 ANDA ANDA085159 Golden State Medical Supply, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 60429-191_0bec7a9e-a2ad-438f-a8e2-fadd552ba009 60429-191 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20150113 ANDA ANDA085159 Golden State Medical Supply, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 60429-195_08e73f03-0753-46ff-94cc-75a7ed41d72f 60429-195 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20110602 ANDA ANDA077538 Golden State Medical Supply, Inc. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60429-196_e54abb21-d338-47d6-9aa5-f523875f2cf8 60429-196 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20131113 ANDA ANDA091681 Golden State Medical Supply, Inc. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 60429-197_d1dd5b96-85d7-458f-a701-e5699bec49e2 60429-197 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141204 ANDA ANDA074587 Golden State Medical Supply, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 60429-198_d1dd5b96-85d7-458f-a701-e5699bec49e2 60429-198 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141204 ANDA ANDA074587 Golden State Medical Supply, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 60429-199_d1dd5b96-85d7-458f-a701-e5699bec49e2 60429-199 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141204 ANDA ANDA074587 Golden State Medical Supply, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 60429-201_7329ba35-a4f0-4a39-b65c-9a25e8bcf008 60429-201 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20140221 ANDA ANDA076113 Golden State Medical Supply, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-202_7329ba35-a4f0-4a39-b65c-9a25e8bcf008 60429-202 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20140221 ANDA ANDA076113 Golden State Medical Supply, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-203_7329ba35-a4f0-4a39-b65c-9a25e8bcf008 60429-203 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20140221 ANDA ANDA076113 Golden State Medical Supply, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-204_29081356-8285-4c27-831b-17d4d88dd4f3 60429-204 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 20120402 ANDA ANDA087127 Golden State Medical Supply, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 60429-205_29081356-8285-4c27-831b-17d4d88dd4f3 60429-205 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 20120402 ANDA ANDA087128 Golden State Medical Supply, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 60429-206_38cd6e4c-b3fb-43e7-97cd-5f1343a8c75b 60429-206 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20150107 ANDA ANDA076071 Golden State Medical Supply, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60429-207_38cd6e4c-b3fb-43e7-97cd-5f1343a8c75b 60429-207 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20150107 ANDA ANDA076071 Golden State Medical Supply, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60429-208_38cd6e4c-b3fb-43e7-97cd-5f1343a8c75b 60429-208 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20150107 ANDA ANDA076071 Golden State Medical Supply, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60429-209_38cd6e4c-b3fb-43e7-97cd-5f1343a8c75b 60429-209 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20150107 ANDA ANDA076071 Golden State Medical Supply, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60429-210_90e93d09-192e-4c25-9851-4df7a39036b0 60429-210 HUMAN PRESCRIPTION DRUG Tranylcypromine Sulfate tranylcypromine sulfate TABLET ORAL 20131018 ANDA ANDA040640 Golden State Medical Supply, Inc. TRANYLCYPROMINE SULFATE 10 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 60429-211_38cd6e4c-b3fb-43e7-97cd-5f1343a8c75b 60429-211 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20150107 ANDA ANDA076071 Golden State Medical Supply, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60429-212_38cd6e4c-b3fb-43e7-97cd-5f1343a8c75b 60429-212 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20150107 ANDA ANDA076071 Golden State Medical Supply, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60429-214_4c3f69cb-ee90-4500-80b6-15b82f669a85 60429-214 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140723 ANDA ANDA203018 Golden State Medical Supply, Inc HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-215_4c3f69cb-ee90-4500-80b6-15b82f669a85 60429-215 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140723 ANDA ANDA203018 Golden State Medical Supply, Inc HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-216_ce062498-854c-4ace-b4d1-da4baabbc20b 60429-216 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140624 ANDA ANDA079095 Golden State Medical Supply, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60429-217_ce062498-854c-4ace-b4d1-da4baabbc20b 60429-217 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140624 ANDA ANDA079095 Golden State Medical Supply, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60429-218_ce062498-854c-4ace-b4d1-da4baabbc20b 60429-218 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140624 ANDA ANDA079095 Golden State Medical Supply, Inc. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60429-219_7234812f-c6fd-41db-a2d8-29fd90c7b899 60429-219 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20140422 ANDA ANDA075682 Golden State Medical Supply, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-220_7234812f-c6fd-41db-a2d8-29fd90c7b899 60429-220 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20140422 ANDA ANDA075682 Golden State Medical Supply, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-221_7234812f-c6fd-41db-a2d8-29fd90c7b899 60429-221 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20140422 ANDA ANDA075682 Golden State Medical Supply, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-222_38eb15e1-a3de-4479-ab0e-cdc986005851 60429-222 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20120822 ANDA ANDA077714 Golden State Medical Supply, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 60429-223_6e408116-d995-4fa1-84e1-723778ddba9b 60429-223 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20080924 ANDA ANDA040808 Golden State Medical Supply, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 60429-224_6e408116-d995-4fa1-84e1-723778ddba9b 60429-224 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20120822 ANDA ANDA040808 Golden State Medical Supply, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 60429-225_6e408116-d995-4fa1-84e1-723778ddba9b 60429-225 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20080924 ANDA ANDA040808 Golden State Medical Supply, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 60429-230_2d082996-ff62-4e65-a4b1-191520238c6a 60429-230 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Golden State Medical Supply, Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 60429-232_1d4c3ebc-365b-4bea-8eb2-913c00db3b2d 60429-232 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium rabeprazole TABLET, DELAYED RELEASE ORAL 20150302 ANDA ANDA076885 Golden State Medical Supply, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 60429-239_1554b8d1-637e-4059-8366-18a544610dd6 60429-239 HUMAN PRESCRIPTION DRUG NEOMYCIN SULFATE NEOMYCIN SULFATE TABLET ORAL 20110103 ANDA ANDA065468 Golden State Medical Supply, Inc. NEOMYCIN SULFATE 500 mg/1 Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 60429-241_7878866f-3680-4f6d-8379-b7eba5d8c3d3 60429-241 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20130108 ANDA ANDA076533 Golden State Medical Supply, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60429-242_7878866f-3680-4f6d-8379-b7eba5d8c3d3 60429-242 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20130108 ANDA ANDA076533 Golden State Medical Supply, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60429-243_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-243 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980405 ANDA ANDA075078 Golden State Medical Supply, Inc. ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-244_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-244 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 19980405 ANDA ANDA075078 Golden State Medical Supply, Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-245_4d3c4f96-2f7a-43c1-a9d2-a7adfcde0e3f 60429-245 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20111115 ANDA ANDA040833 Golden State Medical Supply, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 60429-246_8e495dcd-40f0-4337-a8ca-44c62d5019cd 60429-246 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE, LIQUID FILLED ORAL 20150702 ANDA ANDA073484 Golden State Medical Supply, Inc. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 60429-247_7551b0a2-bfbd-4a9e-9348-654724c13a29 60429-247 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride amiodarone hydrochloride TABLET ORAL 20010330 ANDA ANDA075424 Golden State Medical Supply, Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 60429-248_b0ef9f29-1057-49bf-a097-b9dde090293d 60429-248 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Golden State Medical Supply, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 60429-249_b0ef9f29-1057-49bf-a097-b9dde090293d 60429-249 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Golden State Medical Supply, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 60429-250_b0ef9f29-1057-49bf-a097-b9dde090293d 60429-250 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Golden State Medical Supply, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 60429-251_46e661aa-b1bd-465e-a800-03bd3455d7d1 60429-251 HUMAN PRESCRIPTION DRUG Methscopolamine Methscopolamine Bromide TABLET ORAL 20061228 ANDA ANDA040624 Golden State Medical Supply, Inc. METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 60429-252_0ea5d62d-a469-470b-98dc-9fb97dd15478 60429-252 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 Golden State Medical Supply, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 60429-253_0ea5d62d-a469-470b-98dc-9fb97dd15478 60429-253 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 19980818 ANDA ANDA040336 Golden State Medical Supply, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 500; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 60429-258_fab485f2-849b-4efa-9c67-83df930d5f5e 60429-258 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20150424 ANDA ANDA071017 Golden State Medical Supply, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 60429-259_fab485f2-849b-4efa-9c67-83df930d5f5e 60429-259 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20150424 ANDA ANDA071017 Golden State Medical Supply, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 60429-263_49cf4b47-c904-4c53-85f2-55eda4269463 60429-263 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 20150316 ANDA ANDA062396 Golden State Medical Supply, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 60429-264_cae35088-6c5e-40c4-9f68-e44c5461a5a1 60429-264 HUMAN PRESCRIPTION DRUG Budesonide budesonide CAPSULE ORAL 20150710 ANDA ANDA090410 Golden State Medical Supply, Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60429-265_8960bb24-e6ea-4964-8810-da0b5a10f7f6 60429-265 HUMAN PRESCRIPTION DRUG Hydroxyurea Hydroxyurea CAPSULE ORAL 20121026 ANDA ANDA075340 Golden State Medical Supply, Inc. HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] N 20181231 60429-270_d21db27b-2e70-4e74-851b-1d004c78455c 60429-270 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20130621 ANDA ANDA075876 Golden State Medical Supply, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60429-271_d21db27b-2e70-4e74-851b-1d004c78455c 60429-271 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20130621 ANDA ANDA075876 Golden State Medical Supply, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60429-272_e09efb85-9c06-4059-9aff-371dbf8aaf52 60429-272 HUMAN PRESCRIPTION DRUG Flutamide Flutamide CAPSULE ORAL 20010918 ANDA ANDA075298 Golden State Medical Supply, Inc. FLUTAMIDE 125 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 60429-275_bb8836fe-2b6c-4495-a48c-1cca8519f305 60429-275 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL 20150831 ANDA ANDA070346 Golden State Medical Supply, Inc. AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 60429-277_081e7572-b769-4078-873d-ab5a6d9ad464 60429-277 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20130416 ANDA ANDA075133 Golden State Medical Supply, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60429-278_081e7572-b769-4078-873d-ab5a6d9ad464 60429-278 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20130416 ANDA ANDA075133 Golden State Medical Supply, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60429-279_081e7572-b769-4078-873d-ab5a6d9ad464 60429-279 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20130416 ANDA ANDA075133 Golden State Medical Supply, Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60429-280_12840dcc-8320-4f90-921a-00f8a609c262 60429-280 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride ER Metformin Hydrochloride ER TABLET, FILM COATED ORAL 20060412 ANDA ANDA076869 Golden State Medical Supply, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 60429-286_7371c35d-39e7-4e32-8c4c-f7ef4c42e8b8 60429-286 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20130108 ANDA ANDA200654 Golden State Medical Supply, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 60429-287_125f3379-06f9-4486-b03e-a20270175428 60429-287 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Golden State Medical Supply, Inc. CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60429-288_125f3379-06f9-4486-b03e-a20270175428 60429-288 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Golden State Medical Supply, Inc. CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60429-289_0d0608c9-aced-4795-ad4d-791a40cc23c0 60429-289 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Golden State Medical Supply, Inc. CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60429-290_22a99f74-2718-48b3-b686-caf102d3071c 60429-290 HUMAN PRESCRIPTION DRUG Flavoxate Hydrochloride Flavoxate Hydrochloride TABLET ORAL 20110221 ANDA ANDA076835 Golden State Medical Supply, Inc. FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 60429-291_44e2b2f7-b71c-4c33-a00d-d7ebfb6fb18d 60429-291 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20150209 ANDA ANDA076008 Golden State Medical Supply, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 60429-292_44e2b2f7-b71c-4c33-a00d-d7ebfb6fb18d 60429-292 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20150209 ANDA ANDA076008 Golden State Medical Supply, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 60429-293_44e2b2f7-b71c-4c33-a00d-d7ebfb6fb18d 60429-293 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20150209 ANDA ANDA076008 Golden State Medical Supply, Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 60429-294_30806272-0e5e-4601-a262-d512811338a8 60429-294 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140520 ANDA ANDA201507 Golden State Medical Supply, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 60429-295_30806272-0e5e-4601-a262-d512811338a8 60429-295 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140520 ANDA ANDA201507 Golden State Medical Supply, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 60429-297_d1412f49-55de-4caf-b7e6-e8945ea81845 60429-297 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20110826 ANDA ANDA074415 Golden State Medical Supply, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 60429-298_e37a60be-4479-4897-84c5-488125e8e174 60429-298 HUMAN PRESCRIPTION DRUG Nevirapine nevirapine TABLET ORAL 20120522 ANDA ANDA203176 Golden State Medical Supply, Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 60429-299_47b48b17-c446-45ca-bf2d-9907fe8e3430 60429-299 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20111220 ANDA ANDA074116 Golden State Medical Supply, Inc. PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60429-300_47b48b17-c446-45ca-bf2d-9907fe8e3430 60429-300 HUMAN PRESCRIPTION DRUG Piroxicam piroxicam CAPSULE ORAL 20111220 ANDA ANDA074118 Golden State Medical Supply, Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60429-301_5d8a4054-4df9-49f5-bf4b-383d4dbe3281 60429-301 HUMAN PRESCRIPTION DRUG clopidogrel bisulfate clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076274 Golden State Medical Supply, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 60429-309_34ffff67-7280-4918-980d-e11fb7fc04c8 60429-309 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20130531 ANDA ANDA077309 Golden State Medical Supply, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60429-310_34ffff67-7280-4918-980d-e11fb7fc04c8 60429-310 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20130531 ANDA ANDA077309 Golden State Medical Supply, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60429-311_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-311 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980311 ANDA ANDA075074 Golden State Medical Supply, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-312_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-312 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980312 ANDA ANDA075074 Golden State Medical Supply, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-313_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-313 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Golden State Medical Supply, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-314_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-314 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Golden State Medical Supply, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-315_4934f1b8-ca20-4ed9-9682-9203974ceced 60429-315 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Golden State Medical Supply, Inc. ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60429-316_2ebd1e08-2500-463a-902c-7fd18ecc2d82 60429-316 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110222 ANDA ANDA091129 Golden State Medical Supply, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 60429-317_2ebd1e08-2500-463a-902c-7fd18ecc2d82 60429-317 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110222 ANDA ANDA091129 Golden State Medical Supply, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 60429-318_2ebd1e08-2500-463a-902c-7fd18ecc2d82 60429-318 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110222 ANDA ANDA091129 Golden State Medical Supply, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 60429-319_504d0066-a070-41b0-95b7-09994e4ff03e 60429-319 HUMAN PRESCRIPTION DRUG LEFLUNOMIDE LEFLUNOMIDE TABLET ORAL 20050913 ANDA ANDA077090 Golden State Medical Supply, Inc. LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] E 20171231 60429-320_504d0066-a070-41b0-95b7-09994e4ff03e 60429-320 HUMAN PRESCRIPTION DRUG LEFLUNOMIDE LEFLUNOMIDE TABLET ORAL 20050913 ANDA ANDA077090 Golden State Medical Supply, Inc. LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] E 20171231 60429-323_c478b50d-028a-4c54-8c2c-ba6c7e635cb3 60429-323 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Golden State Medical Supply, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 60429-324_c478b50d-028a-4c54-8c2c-ba6c7e635cb3 60429-324 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Golden State Medical Supply, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 60429-325_c478b50d-028a-4c54-8c2c-ba6c7e635cb3 60429-325 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Golden State Medical Supply, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 60429-326_c478b50d-028a-4c54-8c2c-ba6c7e635cb3 60429-326 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Golden State Medical Supply, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 60429-328_3e40c82c-e719-41bf-8fae-4d4a88e4f05a 60429-328 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20141126 20180630 ANDA ANDA040114 Golden State Medical Supply, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 60429-340_c1bd3abb-d188-41d9-a145-cb2b0920c610 60429-340 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20120402 ANDA ANDA091256 Golden State Medical Supply, Inc. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 60429-342_c1bd3abb-d188-41d9-a145-cb2b0920c610 60429-342 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20120402 ANDA ANDA091256 Golden State Medical Supply, Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 60429-343_c1bd3abb-d188-41d9-a145-cb2b0920c610 60429-343 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20120402 ANDA ANDA091256 Golden State Medical Supply, Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 60429-348_afd48e96-a64e-4e5a-ba21-504a53855397 60429-348 HUMAN PRESCRIPTION DRUG Phenelzine Sulfate Phenelzine Sulfate TABLET ORAL 20101214 ANDA ANDA200181 Golden State Medical Supply, Inc. PHENELZINE SULFATE 15 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] E 20171231 60429-349_49d44b00-a624-47ce-802b-bdc40439a3c4 60429-349 HUMAN PRESCRIPTION DRUG Levetiracetam Extended-Release levetiracetam TABLET, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091261 Golden State Medical Supply, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 60429-350_49d44b00-a624-47ce-802b-bdc40439a3c4 60429-350 HUMAN PRESCRIPTION DRUG Levetiracetam Extended-Release levetiracetam TABLET, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091261 Golden State Medical Supply, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 60429-353_f3637209-303e-4232-ae79-07315a990973 60429-353 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20111202 ANDA ANDA091606 Golden State Medical Supply, Inc. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 60429-354_f3637209-303e-4232-ae79-07315a990973 60429-354 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20111202 ANDA ANDA091606 Golden State Medical Supply, Inc. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 60429-357_b800391e-f064-4436-b475-e8247359fa54 60429-357 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140624 ANDA ANDA077285 Golden State Medical Supply, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60429-358_b800391e-f064-4436-b475-e8247359fa54 60429-358 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140624 ANDA ANDA077285 Golden State Medical Supply, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60429-359_4cb36ce9-4051-4f63-b1fa-4efac62f74c0 60429-359 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20130319 ANDA ANDA091480 Golden State Medical Supply, Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60429-360_4cb36ce9-4051-4f63-b1fa-4efac62f74c0 60429-360 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20130319 ANDA ANDA091480 Golden State Medical Supply, Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60429-361_4cb36ce9-4051-4f63-b1fa-4efac62f74c0 60429-361 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20130319 ANDA ANDA091480 Golden State Medical Supply, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60429-364_9dcbdfb5-0ee4-45b2-8351-001ed2e1a1f5 60429-364 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20080409 ANDA ANDA077747 Golden State Medical Supply, Inc. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 60429-365_9dcbdfb5-0ee4-45b2-8351-001ed2e1a1f5 60429-365 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20080409 ANDA ANDA077747 Golden State Medical Supply, Inc. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 60429-366_9dcbdfb5-0ee4-45b2-8351-001ed2e1a1f5 60429-366 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20080409 ANDA ANDA077747 Golden State Medical Supply, Inc. OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 60429-367_28b5c29e-5051-4df8-b76c-89225937f76d 60429-367 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Golden State Medical Supply PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60429-368_28b5c29e-5051-4df8-b76c-89225937f76d 60429-368 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Golden State Medical Supply PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60429-369_28b5c29e-5051-4df8-b76c-89225937f76d 60429-369 HUMAN PRESCRIPTION DRUG Pravastatin Sodium pravastatin sodium TABLET ORAL 20110718 ANDA ANDA076341 Golden State Medical Supply PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60429-377_a390661c-d7c7-48a4-9220-f0074e1ca8e8 60429-377 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20151118 ANDA ANDA090596 Golden State Medical Supply, Inc. TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 60429-378_a390661c-d7c7-48a4-9220-f0074e1ca8e8 60429-378 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20151118 ANDA ANDA090596 Golden State Medical Supply, Inc. TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 60429-379_a390661c-d7c7-48a4-9220-f0074e1ca8e8 60429-379 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20151118 ANDA ANDA090596 Golden State Medical Supply, Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 60429-380_056eb843-4e6a-494a-8db2-5e3fa836c3a5 60429-380 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20130531 ANDA ANDA040734 Golden State Medical Supply Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 60429-381_056eb843-4e6a-494a-8db2-5e3fa836c3a5 60429-381 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20130531 ANDA ANDA040734 Golden State Medical Supply Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 60429-385_8194f099-d8dc-43fe-864c-e081dd201468 60429-385 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20150506 ANDA ANDA077169 Golden State Medical Supply, Inc. ISRADIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60429-386_8194f099-d8dc-43fe-864c-e081dd201468 60429-386 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20150506 ANDA ANDA077169 Golden State Medical Supply, Inc. ISRADIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60429-388_1fbac843-e51d-4b9d-af4b-9747307acb8c 60429-388 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine TABLET, FILM COATED ORAL 20140320 ANDA ANDA077081 Golden State Medical Supply, Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 60429-389_1fbac843-e51d-4b9d-af4b-9747307acb8c 60429-389 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine TABLET, FILM COATED ORAL 20140320 ANDA ANDA077081 Golden State Medical Supply, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 60429-390_56d4a4ad-fbfc-4098-9a7d-1348a250b212 60429-390 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride sotalol hydrochloride TABLET ORAL 20030909 ANDA ANDA076214 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] E 20171231 60429-391_56d4a4ad-fbfc-4098-9a7d-1348a250b212 60429-391 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride sotalol hydrochloride TABLET ORAL 20030909 ANDA ANDA076214 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] E 20171231 60429-392_56d4a4ad-fbfc-4098-9a7d-1348a250b212 60429-392 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride sotalol hydrochloride TABLET ORAL 20030909 ANDA ANDA076214 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] E 20171231 60429-393_a2243a39-ed8d-468a-a0fd-9b3c5228b8fc 60429-393 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20150310 ANDA ANDA091072 Golden State Medical Supply, Inc. RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60429-394_a2243a39-ed8d-468a-a0fd-9b3c5228b8fc 60429-394 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20150310 ANDA ANDA091072 Golden State Medical Supply, Inc. RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60429-395_a2243a39-ed8d-468a-a0fd-9b3c5228b8fc 60429-395 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20150310 ANDA ANDA091072 Golden State Medical Supply, Inc. RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60429-396_a2243a39-ed8d-468a-a0fd-9b3c5228b8fc 60429-396 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20150310 ANDA ANDA091072 Golden State Medical Supply, Inc. RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60429-400_4e129a3a-4e8d-45e4-addb-a057d1ecf504 60429-400 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140624 ANDA ANDA075828 Golden State Medical Supply, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60429-401_4e129a3a-4e8d-45e4-addb-a057d1ecf504 60429-401 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140624 ANDA ANDA075828 Golden State Medical Supply, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60429-402_4e129a3a-4e8d-45e4-addb-a057d1ecf504 60429-402 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140624 ANDA ANDA075828 Golden State Medical Supply, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60429-403_7ede8a4d-afc2-40d8-bd58-685b00e8c84a 60429-403 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20150209 ANDA ANDA078794 Golden State Medical Supply, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-404_7ede8a4d-afc2-40d8-bd58-685b00e8c84a 60429-404 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20150209 ANDA ANDA078794 Golden State Medical Supply, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-405_7ede8a4d-afc2-40d8-bd58-685b00e8c84a 60429-405 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20150209 ANDA ANDA078794 Golden State Medical Supply, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-406_7ede8a4d-afc2-40d8-bd58-685b00e8c84a 60429-406 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20150209 ANDA ANDA078794 Golden State Medical Supply, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-413_39415f4f-1f84-4afc-af48-f2d2d7a0a4fa 60429-413 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20150701 ANDA ANDA090960 Golden State Medical Supply, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-414_39415f4f-1f84-4afc-af48-f2d2d7a0a4fa 60429-414 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20150701 ANDA ANDA090960 Golden State Medical Supply, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-415_39415f4f-1f84-4afc-af48-f2d2d7a0a4fa 60429-415 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20150701 ANDA ANDA090960 Golden State Medical Supply, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-416_39415f4f-1f84-4afc-af48-f2d2d7a0a4fa 60429-416 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20150701 ANDA ANDA090960 Golden State Medical Supply, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-417_39415f4f-1f84-4afc-af48-f2d2d7a0a4fa 60429-417 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20150701 ANDA ANDA090960 Golden State Medical Supply, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-418_39415f4f-1f84-4afc-af48-f2d2d7a0a4fa 60429-418 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20150701 ANDA ANDA090960 Golden State Medical Supply, Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-421_4c2f191e-f799-47c8-a37c-cae4f5f4fa10 60429-421 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20150727 ANDA ANDA074514 GSMS, Incorporated DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 60429-422_4c2f191e-f799-47c8-a37c-cae4f5f4fa10 60429-422 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20150727 ANDA ANDA074514 GSMS, Incorporated DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 60429-431_ee3878f7-723c-4456-a3c1-f20eb0ae6e2d 60429-431 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Extended-Release Clonidine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20150904 ANDA ANDA202984 Golden State Medical Supply, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60429-432_32d99cfa-88ef-4679-bfc7-f3132c13f1b8 60429-432 HUMAN PRESCRIPTION DRUG Fenofibric Acid Delayed-Release Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20110812 ANDA ANDA201573 Golden State Medical Supply, Inc. CHOLINE FENOFIBRATE 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 60429-433_a2781862-238c-4152-a1be-b27ae9716ede 60429-433 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20150904 ANDA ANDA072423 Golden State Medical Supply, Inc. MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 60429-434_c4e79545-f00f-44d5-ae54-f1ac9cfb33a3 60429-434 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20150910 ANDA ANDA077463 Golden State Medical Supply, Inc. NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 60429-435_c4e79545-f00f-44d5-ae54-f1ac9cfb33a3 60429-435 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20150910 ANDA ANDA077463 Golden State Medical Supply, Inc. NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 60429-437_6d3cedbd-ad35-41c0-9dcf-5df5581ef97c 60429-437 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150915 ANDA ANDA078540 Golden State Medical Supply, Inc. PROPAFENONE HYDROCHLORIDE 325 mg/1 Antiarrhythmic [EPC] N 20181231 60429-438_6d3cedbd-ad35-41c0-9dcf-5df5581ef97c 60429-438 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150915 ANDA ANDA078540 Golden State Medical Supply, Inc. PROPAFENONE HYDROCHLORIDE 425 mg/1 Antiarrhythmic [EPC] N 20181231 60429-440_2e7a181d-c3f2-4b4e-991c-ce22121f327b 60429-440 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20150904 ANDA ANDA086923 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 60429-441_2e7a181d-c3f2-4b4e-991c-ce22121f327b 60429-441 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20150904 ANDA ANDA086925 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 60429-442_2e7a181d-c3f2-4b4e-991c-ce22121f327b 60429-442 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20150904 ANDA ANDA087537 Golden State Medical Supply, Inc. ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 60429-443_96bac1bf-9bb5-49eb-b9b9-d51fc466b89c 60429-443 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150923 NDA NDA020076 Golden State Medical Supply, Inc. NICOTINE 7 mg/24h N 20181231 60429-444_96bac1bf-9bb5-49eb-b9b9-d51fc466b89c 60429-444 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150923 NDA NDA020076 Golden State Medical Supply, Inc. NICOTINE 14 mg/24h N 20181231 60429-445_96bac1bf-9bb5-49eb-b9b9-d51fc466b89c 60429-445 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20150923 NDA NDA020076 Golden State Medical Supply, Inc. NICOTINE 21 mg/24h N 20181231 60429-446_853693f7-7144-4419-8e49-00f1c4852044 60429-446 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150728 ANDA ANDA078583 Golden State Medical Supply, Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-447_853693f7-7144-4419-8e49-00f1c4852044 60429-447 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150728 ANDA ANDA078583 Golden State Medical Supply, Inc. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-448_853693f7-7144-4419-8e49-00f1c4852044 60429-448 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150728 ANDA ANDA078583 Golden State Medical Supply, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-449_853693f7-7144-4419-8e49-00f1c4852044 60429-449 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150728 ANDA ANDA078583 Golden State Medical Supply, Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-450_853693f7-7144-4419-8e49-00f1c4852044 60429-450 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150728 ANDA ANDA078583 Golden State Medical Supply, Inc. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-451_853693f7-7144-4419-8e49-00f1c4852044 60429-451 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150728 ANDA ANDA078583 Golden State Medical Supply, Inc. ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-459_7a2d650d-d656-4969-a432-d5dae694abcd 60429-459 HUMAN PRESCRIPTION DRUG Celecoxib celecoxib CAPSULE ORAL 20150909 ANDA ANDA078857 Golden State Medical Supply, Inc. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60429-460_7a2d650d-d656-4969-a432-d5dae694abcd 60429-460 HUMAN PRESCRIPTION DRUG Celecoxib celecoxib CAPSULE ORAL 20151109 ANDA ANDA078857 Golden State Medical Supply, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60429-461_7a2d650d-d656-4969-a432-d5dae694abcd 60429-461 HUMAN PRESCRIPTION DRUG Celecoxib celecoxib CAPSULE ORAL 20151109 ANDA ANDA078857 Golden State Medical Supply, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60429-462_7a2d650d-d656-4969-a432-d5dae694abcd 60429-462 HUMAN PRESCRIPTION DRUG Celecoxib celecoxib CAPSULE ORAL 20151109 ANDA ANDA078857 Golden State Medical Supply, Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60429-481_70ccced6-7e9a-4e9f-8958-dde706d74115 60429-481 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20151207 ANDA ANDA202539 Golden State Medical Supply, Inc. PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 60429-482_70ccced6-7e9a-4e9f-8958-dde706d74115 60429-482 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20151207 ANDA ANDA202539 Golden State Medical Supply, Inc. PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 60429-483_70ccced6-7e9a-4e9f-8958-dde706d74115 60429-483 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20151207 ANDA ANDA202539 Golden State Medical Supply, Inc. PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 60429-484_8e4d76bf-8387-4dc1-b08b-aef6890ec92b 60429-484 HUMAN PRESCRIPTION DRUG REPAGLINIDE REPAGLINIDE TABLET ORAL 20151207 ANDA ANDA091517 Golden State Medical Supply, Inc. REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 60429-485_8e4d76bf-8387-4dc1-b08b-aef6890ec92b 60429-485 HUMAN PRESCRIPTION DRUG REPAGLINIDE REPAGLINIDE TABLET ORAL 20151217 ANDA ANDA091517 Golden State Medical Supply, Inc. REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 60429-486_8e4d76bf-8387-4dc1-b08b-aef6890ec92b 60429-486 HUMAN PRESCRIPTION DRUG REPAGLINIDE REPAGLINIDE TABLET ORAL 20151217 ANDA ANDA091517 Golden State Medical Supply, Inc. REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 60429-491_a8eee952-54b9-4680-bab6-f90f7e4efb6b 60429-491 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20151222 ANDA ANDA203179 Golden State Medical Supply, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 60429-495_69248ad0-6998-42a2-88a9-fa682e5ea5ee 60429-495 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20160509 ANDA ANDA203887 Golden State Medical Supply, Inc. DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] E 20171231 60429-496_69248ad0-6998-42a2-88a9-fa682e5ea5ee 60429-496 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20160509 ANDA ANDA203887 Golden State Medical Supply, Inc. DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] E 20171231 60429-500_245c04dc-20c2-42d5-a0d8-8e79324e94b9 60429-500 HUMAN PRESCRIPTION DRUG Tramadol hydrochloride and acetaminophen Tramadol hydrochloride and acetaminophen TABLET ORAL 20150209 ANDA ANDA078778 Golden State Medical Supply, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 60429-502_fc4262ca-f03c-4136-ad2f-906beba582ed 60429-502 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19931019 ANDA ANDA074174 Golden State Medical Supply, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 60429-503_fc4262ca-f03c-4136-ad2f-906beba582ed 60429-503 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19931019 ANDA ANDA074174 Golden State Medical Supply, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 60429-504_fc4262ca-f03c-4136-ad2f-906beba582ed 60429-504 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19931019 ANDA ANDA074174 Golden State Medical Supply, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 60429-505_fc4262ca-f03c-4136-ad2f-906beba582ed 60429-505 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19931019 ANDA ANDA074174 Golden State Medical Supply, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 60429-506_abdeee37-d0d8-4f22-a977-f8ea37c51f03 60429-506 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20140110 ANDA ANDA071638 Golden State Medical Supply, Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 60429-507_abdeee37-d0d8-4f22-a977-f8ea37c51f03 60429-507 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20140110 ANDA ANDA071620 Golden State Medical Supply, Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 60429-508_4725d447-518f-47a1-ac88-da74a0964792 60429-508 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20140220 ANDA ANDA203374 Golden State Medical Supply, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 60429-510_c9b5eb2c-d593-40e7-b959-d5771bba531b 60429-510 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20110519 20180901 ANDA ANDA040201 Golden State Medical Supply, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 60429-516_6a66aae6-4ded-4524-b298-831fc6a76854 60429-516 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20150910 ANDA ANDA090659 Golden State Medical Supply, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60429-517_6a66aae6-4ded-4524-b298-831fc6a76854 60429-517 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20150910 ANDA ANDA090659 Golden State Medical Supply, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60429-519_6a66aae6-4ded-4524-b298-831fc6a76854 60429-519 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20150910 ANDA ANDA090659 Golden State Medical Supply, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60429-520_6a66aae6-4ded-4524-b298-831fc6a76854 60429-520 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20150910 ANDA ANDA090659 Golden State Medical Supply, Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60429-521_6a66aae6-4ded-4524-b298-831fc6a76854 60429-521 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20150910 ANDA ANDA090659 Golden State Medical Supply, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60429-524_f158cdc4-b7dc-43fe-86f5-db1d7186e5cc 60429-524 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20131018 ANDA ANDA074869 Golden State Medical Supply, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60429-525_f158cdc4-b7dc-43fe-86f5-db1d7186e5cc 60429-525 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20131018 ANDA ANDA074869 Golden State Medical Supply, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60429-526_f158cdc4-b7dc-43fe-86f5-db1d7186e5cc 60429-526 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20131018 ANDA ANDA074869 Golden State Medical Supply, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60429-554_7b519d5e-c8d3-4e89-bf4f-68118171b8ad 60429-554 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20110812 ANDA ANDA085461 Golden State Medical Supply, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60429-555_7b519d5e-c8d3-4e89-bf4f-68118171b8ad 60429-555 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20110812 ANDA ANDA085472 Golden State Medical Supply, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60429-556_7b519d5e-c8d3-4e89-bf4f-68118171b8ad 60429-556 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20110812 ANDA ANDA085475 Golden State Medical Supply, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60429-570_679372cf-0f50-4c94-9370-77ea7649aa50 60429-570 HUMAN PRESCRIPTION DRUG Pentazocine and Naloxone Pentazocine hydrochloride and naloxone hydrochloride TABLET ORAL 20000324 ANDA ANDA074736 Golden State Medical Supply, Inc. PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 50; .5 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV E 20171231 60429-576_cc0b862e-1c28-4adb-b9b7-e83ef5152cb6 60429-576 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20100520 ANDA ANDA040300 Golden State Medical Supply, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 60429-577_cc0b862e-1c28-4adb-b9b7-e83ef5152cb6 60429-577 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20100520 ANDA ANDA040300 Golden State Medical Supply, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 60429-578_cc0b862e-1c28-4adb-b9b7-e83ef5152cb6 60429-578 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20100520 ANDA ANDA040300 Golden State Medical Supply, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 60429-579_cc0b862e-1c28-4adb-b9b7-e83ef5152cb6 60429-579 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride ER Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100520 ANDA ANDA075629 Golden State Medical Supply, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 60429-580_cc0b862e-1c28-4adb-b9b7-e83ef5152cb6 60429-580 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride ER Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100520 ANDA ANDA075629 Golden State Medical Supply, Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 60429-581_2e7014fb-7c86-4b53-909b-09fbf7bdd679 60429-581 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20140203 ANDA ANDA077667 Golden State Medical Supply, Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 60429-582_2e7014fb-7c86-4b53-909b-09fbf7bdd679 60429-582 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20140203 ANDA ANDA077667 Golden State Medical Supply, Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 60429-583_c3756dd4-1e86-4a1e-af5c-1d7e85cb530a 60429-583 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Extended-Release tramadol hydrochloride extended-release tablets TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161020 ANDA ANDA200491 Golden State Medical Supply, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 60429-584_c3756dd4-1e86-4a1e-af5c-1d7e85cb530a 60429-584 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Extended-Release Tramadol Hydrochloride Extended-Release Tablets TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161020 ANDA ANDA200491 Golden State Medical Supply, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 60429-585_c3756dd4-1e86-4a1e-af5c-1d7e85cb530a 60429-585 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Extended-Release Tramadol Hydrochloride Extended-Release Tablets TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161020 ANDA ANDA200491 Golden State Medical Supply, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 60429-586_730f03f2-3056-4b3b-8575-3a8bc0fdd48e 60429-586 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20160119 ANDA ANDA204431 Golden State Medical Supply, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 60429-587_730f03f2-3056-4b3b-8575-3a8bc0fdd48e 60429-587 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20160119 ANDA ANDA204431 Golden State Medical Supply, Inc. BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 60429-588_d0a69988-a0a9-4ce1-9f2a-e8656d7e7b1f 60429-588 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20170608 ANDA ANDA075977 GSMS, Incorporated TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20191231 60429-589_2ed2e798-0d95-4ae2-a63d-2d66db009a71 60429-589 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 20180108 ANDA ANDA089175 Golden State Medical Supply, Inc BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20191231 60429-616_266e54ce-b327-4dcf-8fc7-b61aa7cc8df6 60429-616 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Vitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, .Alpha.-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE ORAL 20101217 UNAPPROVED DRUG OTHER Golden State Medical Supply, Inc. VITAMIN A; VITAMIN D; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; FLUORIDE ION; ASCORBIC ACID; ALPHA-TOCOPHEROL ACETATE; CYANOCOBALAMIN 2500; 400; 1.05; 1.2; 13.5; 1.05; .3; .25; 60; 15; 4.5 [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; ug/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 60429-617_266e54ce-b327-4dcf-8fc7-b61aa7cc8df6 60429-617 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Vitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, .Alpha.-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE ORAL 20101229 UNAPPROVED DRUG OTHER Golden State Medical Supply, Inc. VITAMIN A; VITAMIN D; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; FLUORIDE ION; ASCORBIC ACID; ALPHA-TOCOPHEROL ACETATE; CYANOCOBALAMIN 2500; 400; 1.05; 1.2; 13.5; 1.05; .3; .5; 60; 15; 4.5 [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; ug/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 60429-618_266e54ce-b327-4dcf-8fc7-b61aa7cc8df6 60429-618 HUMAN PRESCRIPTION DRUG Multi-Vitamin With Fluoride Vitamin A, Vitamin D, Thiamine, Riboflavin, Niacin, Pyridoxine, Folic Acid, Fluoride Ion, Ascorbic Acid, .Alpha.-Tocopherol-Acetate-DL, Cyanocobalamin TABLET, CHEWABLE ORAL 20101217 UNAPPROVED DRUG OTHER Golden State Medical Supply, Inc. VITAMIN A; VITAMIN D; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; FLUORIDE ION; ASCORBIC ACID; ALPHA-TOCOPHEROL ACETATE; CYANOCOBALAMIN 2500; 400; 1.05; 1.2; 13.5; 1.05; .3; 1; 60; 15; 4.5 [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; ug/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 60429-632_2cff8565-e58c-4573-a5f0-3f82f3d3d9e7 60429-632 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20160404 ANDA ANDA091151 Golden State Medical Supply, Inc. ESZOPICLONE 1 mg/1 CIV N 20181231 60429-633_2cff8565-e58c-4573-a5f0-3f82f3d3d9e7 60429-633 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20160404 ANDA ANDA091151 Golden State Medical Supply, Inc. ESZOPICLONE 2 mg/1 CIV N 20181231 60429-634_2cff8565-e58c-4573-a5f0-3f82f3d3d9e7 60429-634 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20160404 ANDA ANDA091151 Golden State Medical Supply, Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 60429-640_125f8727-fd76-41bc-ae3c-f4c1619d72f9 60429-640 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20160205 ANDA ANDA204774 Golden State Medical Supply, Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60429-641_125f8727-fd76-41bc-ae3c-f4c1619d72f9 60429-641 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20160205 ANDA ANDA204774 Golden State Medical Supply, Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60429-642_125f8727-fd76-41bc-ae3c-f4c1619d72f9 60429-642 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20160205 ANDA ANDA204774 Golden State Medical Supply, Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60429-643_e93a872f-31c7-4491-96d2-fbe0508dae2b 60429-643 HUMAN PRESCRIPTION DRUG IBANDRONATE SODIUM IBANDRONATE SODIUM TABLET, FILM COATED ORAL 20160205 ANDA ANDA078948 Golden State Medical Supply, Inc. IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 60429-649_c0491126-48ac-4c30-98c6-286c7d7703eb 60429-649 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20160205 ANDA ANDA065447 Golden State Medical Supply, Inc. DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 60429-650_d25ff3d0-c868-489c-9e8d-0278e06051a3 60429-650 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20160208 ANDA ANDA090324 Golden State Medical Supply, Inc. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 60429-651_d25ff3d0-c868-489c-9e8d-0278e06051a3 60429-651 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20160208 ANDA ANDA090324 Golden State Medical Supply, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 60429-652_d25ff3d0-c868-489c-9e8d-0278e06051a3 60429-652 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20160208 ANDA ANDA090324 Golden State Medical Supply, Inc. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 60429-656_1747f209-2946-4700-858e-33f4773de286 60429-656 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20160222 ANDA ANDA065135 Golden State Medical Supply, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60429-657_1747f209-2946-4700-858e-33f4773de286 60429-657 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20160222 ANDA ANDA065135 Golden State Medical Supply, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60429-662_48e7e53f-3565-4c01-b1d3-81ebe1e7f2a6 60429-662 HUMAN PRESCRIPTION DRUG Ursodiol ursodiol CAPSULE ORAL 20160317 ANDA ANDA090530 Golden State Medical Supply, Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] E 20171231 60429-663_59752beb-a207-4063-9000-e5f7f5006373 60429-663 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET, FILM COATED ORAL 20160205 ANDA ANDA065447 Golden State Medical Supply, Inc. DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 60429-664_a877085d-d3b0-48df-9881-dbae060d421e 60429-664 HUMAN PRESCRIPTION DRUG MOMETASONE FUROATE MOMETASONE FUROATE SPRAY, METERED NASAL 20160329 ANDA ANDA091161 Golden State Medical Supply, Inc. MOMETASONE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60429-665_ec15e70c-8473-469a-9f07-ea668783fa07 60429-665 HUMAN PRESCRIPTION DRUG GLYCOPYRROLATE GLYCOPYRROLATE TABLET ORAL 20160203 ANDA ANDA091182 Golden State Medical Supply, Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 60429-666_ec15e70c-8473-469a-9f07-ea668783fa07 60429-666 HUMAN PRESCRIPTION DRUG GLYCOPYRROLATE GLYCOPYRROLATE TABLET ORAL 20160203 ANDA ANDA091182 Golden State Medical Supply, Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 60429-697_3d6cb23b-1bdd-43b1-b8f5-c7fdd774770a 60429-697 HUMAN PRESCRIPTION DRUG SULINDAC sulindac TABLET ORAL 20160606 ANDA ANDA072050 Golden State Medical Supply, Inc. SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60429-698_3d6cb23b-1bdd-43b1-b8f5-c7fdd774770a 60429-698 HUMAN PRESCRIPTION DRUG SULINDAC sulindac TABLET ORAL 20160606 ANDA ANDA072051 Golden State Medical Supply, Inc. SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60429-703_b218b02c-e6a1-410c-95fa-f798260c51ab 60429-703 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 20010618 ANDA ANDA075191 Golden State Medical Supply, Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] E 20171231 60429-721_4323a38f-a25a-4ec4-a904-002bf5254169 60429-721 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Golden State Medical Supply, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 60429-725_e3d7e34f-442b-471d-af12-0647af973f86 60429-725 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060829 ANDA ANDA076172 Golden State Medical Supply, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 60429-737_426f1773-7c7f-4cd2-bcb7-5af029334238 60429-737 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Golden State Medical Supply, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60429-749_5e5fe652-b697-456e-9ec2-d848f0d6515f 60429-749 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 60429-750_5e5fe652-b697-456e-9ec2-d848f0d6515f 60429-750 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 60429-751_5e5fe652-b697-456e-9ec2-d848f0d6515f 60429-751 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Golden State Medical Supply, Inc. SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 60429-753_9a58c45d-4b14-44d7-86ed-2997ac6942dd 60429-753 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20080627 ANDA ANDA078962 Golden State Medical Supply, Inc. BETAXOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 60429-754_9a58c45d-4b14-44d7-86ed-2997ac6942dd 60429-754 HUMAN PRESCRIPTION DRUG Betaxolol Betaxolol TABLET, FILM COATED ORAL 20080627 ANDA ANDA078962 Golden State Medical Supply, Inc. BETAXOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 60429-765_7520bda4-fff5-486d-b872-9150fbb91f8d 60429-765 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120720 ANDA ANDA077561 Golden State Medical Supply, Inc. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-766_7520bda4-fff5-486d-b872-9150fbb91f8d 60429-766 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120720 ANDA ANDA077561 Golden State Medical Supply, Inc. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-767_7520bda4-fff5-486d-b872-9150fbb91f8d 60429-767 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120720 ANDA ANDA077561 Golden State Medical Supply, Inc. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-768_7520bda4-fff5-486d-b872-9150fbb91f8d 60429-768 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120720 ANDA ANDA077561 Golden State Medical Supply, Inc. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 60429-769_3b062dd5-06d7-4c1b-8e6d-7c1f4065f7bf 60429-769 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20110708 ANDA ANDA079162 Golden State Medical Supply, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60429-770_3b062dd5-06d7-4c1b-8e6d-7c1f4065f7bf 60429-770 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20110708 ANDA ANDA079162 Golden State Medical Supply, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60429-771_3b062dd5-06d7-4c1b-8e6d-7c1f4065f7bf 60429-771 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20110708 ANDA ANDA079162 Golden State Medical Supply, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60429-772_3b062dd5-06d7-4c1b-8e6d-7c1f4065f7bf 60429-772 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20110708 ANDA ANDA079162 Golden State Medical Supply, Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60429-782_0fe4d459-028b-41b2-96a0-93f47f387b92 60429-782 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20060915 ANDA ANDA077661 Golden State Medical Supply, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 60429-783_0fe4d459-028b-41b2-96a0-93f47f387b92 60429-783 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20060915 ANDA ANDA077661 Golden State Medical Supply, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 60429-817_eec979c4-bbd0-4f28-8fe9-d5668b4ec5e2 60429-817 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20160620 ANDA ANDA078881 Golden State Medical Supply, Inc. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60429-818_eec979c4-bbd0-4f28-8fe9-d5668b4ec5e2 60429-818 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20160620 ANDA ANDA078881 Golden State Medical Supply, Inc. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60429-819_eec979c4-bbd0-4f28-8fe9-d5668b4ec5e2 60429-819 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20160620 ANDA ANDA078881 Golden State Medical Supply, Inc. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60429-820_eec979c4-bbd0-4f28-8fe9-d5668b4ec5e2 60429-820 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20160620 ANDA ANDA078881 Golden State Medical Supply, Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60429-821_eec979c4-bbd0-4f28-8fe9-d5668b4ec5e2 60429-821 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20160620 ANDA ANDA078881 Golden State Medical Supply, Inc. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60429-822_eec979c4-bbd0-4f28-8fe9-d5668b4ec5e2 60429-822 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20160620 ANDA ANDA078881 Golden State Medical Supply, Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60429-823_eec979c4-bbd0-4f28-8fe9-d5668b4ec5e2 60429-823 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole TABLET ORAL 20160620 ANDA ANDA078881 Golden State Medical Supply, Inc. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60429-824_6d7ca135-ddd4-439f-b882-8c6d26c94a31 60429-824 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20180101 ANDA ANDA040911 GSMS, Incorporated LIDOCAINE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 60429-825_17f01561-b2d3-4c5a-b9dc-884b29e0e8df 60429-825 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20160721 ANDA ANDA201486 Golden State Medical Supply, Inc. TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 60429-826_17f01561-b2d3-4c5a-b9dc-884b29e0e8df 60429-826 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20160721 ANDA ANDA201486 Golden State Medical Supply, Inc. TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 60429-833_9f06b16a-5886-42a8-8491-423bd19f89e5 60429-833 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20160816 ANDA ANDA040197 Golden State Medical Supply, Inc. ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 60429-834_9f06b16a-5886-42a8-8491-423bd19f89e5 60429-834 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20160816 ANDA ANDA040197 Golden State Medical Supply, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 60429-835_9f06b16a-5886-42a8-8491-423bd19f89e5 60429-835 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20160816 ANDA ANDA040197 Golden State Medical Supply, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 60429-836_15ad9bd0-0df6-42d2-8e2a-6d6e8e44e963 60429-836 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE ORAL 20160829 ANDA ANDA202539 Golden State Medical Supply, Inc. PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 60429-837_15ad9bd0-0df6-42d2-8e2a-6d6e8e44e963 60429-837 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE ORAL 20160829 ANDA ANDA202539 Golden State Medical Supply, Inc. PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 60429-838_15ad9bd0-0df6-42d2-8e2a-6d6e8e44e963 60429-838 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE ORAL 20160829 ANDA ANDA202539 Golden State Medical Supply, Inc. PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 60429-839_f11685f0-70e4-45ea-9aef-49dc6db32e86 60429-839 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET SUBLINGUAL 20160912 ANDA ANDA208191 Golden State Medical Supply, Inc. NITROGLYCERIN .3 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 60429-840_f11685f0-70e4-45ea-9aef-49dc6db32e86 60429-840 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET SUBLINGUAL 20160912 ANDA ANDA208191 Golden State Medical Supply, Inc. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 60429-841_f11685f0-70e4-45ea-9aef-49dc6db32e86 60429-841 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET SUBLINGUAL 20160912 ANDA ANDA208191 Golden State Medical Supply, Inc. NITROGLYCERIN .6 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 60429-849_7fa06539-7d18-4c84-b71e-861723d16c4a 60429-849 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20170221 ANDA ANDA207783 Golden State Medical Supply, Inc. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 60429-850_617eeef5-be71-4163-aaea-f536cad44dd0 60429-850 HUMAN PRESCRIPTION DRUG Darifenacin Hydrobromide Extended-Release Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20170118 ANDA ANDA091190 Golden State Medical Supply, Inc. DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 60429-851_617eeef5-be71-4163-aaea-f536cad44dd0 60429-851 HUMAN PRESCRIPTION DRUG Darifenacin Hydrobromide Extended-Release Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20170118 ANDA ANDA091190 Golden State Medical Supply, Inc. DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 60429-861_1029b313-a052-4d47-96a8-359fc21f5cee 60429-861 HUMAN PRESCRIPTION DRUG Guanfacine guanfacine Hydrochloride TABLET ORAL 20170307 ANDA ANDA074796 Golden State Medical Supply, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60429-862_1029b313-a052-4d47-96a8-359fc21f5cee 60429-862 HUMAN PRESCRIPTION DRUG Guanfacine guanfacine Hydrochloride TABLET ORAL 20170307 ANDA ANDA074796 Golden State Medical Supply, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60429-863_e51259ab-8eec-4ee9-82c0-b86fe031ae2e 60429-863 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20170309 ANDA ANDA076958 Golden State Medical Supply, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60429-864_e51259ab-8eec-4ee9-82c0-b86fe031ae2e 60429-864 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20170309 ANDA ANDA076958 Golden State Medical Supply, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60429-865_e51259ab-8eec-4ee9-82c0-b86fe031ae2e 60429-865 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20170309 ANDA ANDA076958 Golden State Medical Supply, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60429-866_b7f7dda5-95d7-4b58-89af-4fcf57cdec60 60429-866 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20170405 ANDA ANDA205468 Golden State Medical Supply, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60429-867_b7f7dda5-95d7-4b58-89af-4fcf57cdec60 60429-867 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20170405 ANDA ANDA205468 Golden State Medical Supply, Inc. VENLAFAXINE HYDROCHLORIDE 225 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60429-868_cff1f1d4-5f4d-418c-8218-6630137c9a97 60429-868 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20170405 ANDA ANDA208801 Golden State Medical Supply, Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 60429-869_cff1f1d4-5f4d-418c-8218-6630137c9a97 60429-869 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20170405 ANDA ANDA208801 Golden State Medical Supply, Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 60429-876_cd9d042b-4639-4da5-9525-aa62593d55a6 60429-876 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20170407 ANDA ANDA077797 Golden State Medical Supply, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 60429-877_0343995c-718c-465b-82c4-ce236931e946 60429-877 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20170407 ANDA ANDA040412 Golden State Medical Supply, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-878_0343995c-718c-465b-82c4-ce236931e946 60429-878 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20170407 ANDA ANDA040412 Golden State Medical Supply, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-879_a81a0ce1-b576-442b-9156-c501c63f4bef 60429-879 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20170426 ANDA ANDA200909 Golden State Medical Supply, Inc. EZETIMIBE; SIMVASTATIN 10; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60429-880_a81a0ce1-b576-442b-9156-c501c63f4bef 60429-880 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20170426 ANDA ANDA200909 Golden State Medical Supply, Inc. EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60429-881_a81a0ce1-b576-442b-9156-c501c63f4bef 60429-881 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20170426 ANDA ANDA200909 Golden State Medical Supply, Inc. EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60429-882_a81a0ce1-b576-442b-9156-c501c63f4bef 60429-882 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20170426 ANDA ANDA200909 Golden State Medical Supply, Inc. EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60429-887_70cd982c-151e-48a6-a053-9d5ccd65ba69 60429-887 HUMAN PRESCRIPTION DRUG Ethacrynic Acid Ethacrynic Acid TABLET ORAL 20170504 ANDA ANDA207262 Golden State Medical Supply, Inc. ETHACRYNIC ACID 25 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 60429-888_773ccd41-b35f-4bd9-b055-e3b775ed4002 60429-888 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20170608 ANDA ANDA040707 Golden State Medical Supply, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-889_54d009cd-52c9-4a0b-bd61-2d5dbee131f0 60429-889 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20170608 ANDA ANDA083177 Golden State Medical Supply, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-890_54d009cd-52c9-4a0b-bd61-2d5dbee131f0 60429-890 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20170608 ANDA ANDA083177 Golden State Medical Supply, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60429-893_54c551d9-1361-4669-a520-55ebdb1a283d 60429-893 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET ORAL 20171009 ANDA ANDA205348 Golden State Medical Supply, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 60429-899_5980c078-f3ac-4164-a067-0883aab36e11 60429-899 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20170710 ANDA ANDA075347 Golden State Medical Supply, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60429-901_84858c34-e7b5-4a80-ae57-76d486d8c23f 60429-901 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20110521 ANDA ANDA074248 Golden State Medical Supply, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60429-902_cec1e923-dbcf-452b-aefb-452a3d62c0e4 60429-902 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20110521 ANDA ANDA074249 Golden State Medical Supply, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60429-904_3d3ba937-2108-4ace-b2e3-d881f5201461 60429-904 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 NDA NDA019117 Golden State Medical Supply, Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60429-905_27aacc7f-5fd9-4f2b-9c99-3e4331baa998 60429-905 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20160822 ANDA ANDA081297 Golden State Medical Supply, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 60429-907_3d3ba937-2108-4ace-b2e3-d881f5201461 60429-907 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide OINTMENT TOPICAL 19970729 ANDA ANDA074935 Golden State Medical Supply, Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60429-908_3d3ba937-2108-4ace-b2e3-d881f5201461 60429-908 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide SOLUTION TOPICAL 19961231 ANDA ANDA074799 Golden State Medical Supply, Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60429-909_cfd2e863-544d-4f32-b53d-dda6ef26522f 60429-909 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20160928 ANDA ANDA075797 Golden State Medical Supply, Inc. TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 60429-910_cfd2e863-544d-4f32-b53d-dda6ef26522f 60429-910 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20160928 ANDA ANDA074858 Golden State Medical Supply, Inc. TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 60429-912_40e9f506-d1c9-4f7e-87cd-b48f8203970b 60429-912 HUMAN PRESCRIPTION DRUG Omega-3-Acid Ethyl Esters omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20161105 ANDA ANDA091018 Golden State Medical Supply, Inc. OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 60429-914_6f0f31d6-af0e-4140-b672-13b803d254d9 60429-914 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20170118 ANDA ANDA081297 Golden State Medical Supply, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 60429-915_03e8f9c9-c697-4e7d-9b91-57d6a42f441a 60429-915 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20161205 ANDA ANDA207371 Golden State Medical Supply, Inc. VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 60429-916_03e8f9c9-c697-4e7d-9b91-57d6a42f441a 60429-916 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20161205 ANDA ANDA207371 Golden State Medical Supply, Inc. VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 60429-918_4f83e203-c102-47fa-bb8e-4fc5541e0d6f 60429-918 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20090817 ANDA ANDA077911 Golden State Medical Supply, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 60429-919_4f83e203-c102-47fa-bb8e-4fc5541e0d6f 60429-919 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20090817 ANDA ANDA077911 Golden State Medical Supply, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 60429-920_4f83e203-c102-47fa-bb8e-4fc5541e0d6f 60429-920 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20090817 ANDA ANDA077911 Golden State Medical Supply, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 60429-921_a39ad601-5bb3-4414-b532-d1e6e7463ae4 60429-921 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20170103 ANDA ANDA202297 Golden State Medical Supply, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60429-925_ed673680-657e-48b7-9f2b-8e67dae770f1 60429-925 HUMAN PRESCRIPTION DRUG Imatinib Mesylate Imatinib Mesylate TABLET, FILM COATED ORAL 20161230 ANDA ANDA204285 GSMS, Incorporated IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 60429-926_ed673680-657e-48b7-9f2b-8e67dae770f1 60429-926 HUMAN PRESCRIPTION DRUG Imatinib Mesylate Imatinib Mesylate TABLET, FILM COATED ORAL 20161230 ANDA ANDA204285 GSMS, Incorporated IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 60429-927_6f0f31d6-af0e-4140-b672-13b803d254d9 60429-927 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20170118 ANDA ANDA081297 Golden State Medical Supply, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 60429-933_f5fc7d1f-152c-4590-afe1-63ebb648d201 60429-933 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160826 ANDA ANDA077715 Golden State Medical Supply, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60429-934_89505e85-8670-4707-ac24-9dfa25428dee 60429-934 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine TABLET, CHEWABLE ORAL 20110720 ANDA ANDA075687 Golden State Medical Supply, Inc. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 60429-935_55267951-afef-4fd7-9461-d666bb4762c1 60429-935 HUMAN PRESCRIPTION DRUG Dutasteride dutasteride CAPSULE, LIQUID FILLED ORAL 20160920 ANDA ANDA204292 Golden State Medical Supply, Inc. DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 60429-936_309584ff-4353-44bf-bdaf-851ceb0ca7c3 60429-936 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20050224 ANDA ANDA065152 Golden State Medical Supply, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 60429-939_309584ff-4353-44bf-bdaf-851ceb0ca7c3 60429-939 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20050224 ANDA ANDA065152 Golden State Medical Supply, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 60429-946_1a6fba4e-ebcd-4b64-98db-47d5a9a54e0d 60429-946 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 Golden State Medical Supply, Inc BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 60429-947_1a6fba4e-ebcd-4b64-98db-47d5a9a54e0d 60429-947 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100201 ANDA ANDA075491 Golden State Medical Supply, Inc BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 60429-952_1596c0dd-ff24-4900-9555-e9484fe79461 60429-952 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20180126 ANDA ANDA077806 GSMS, Incorporated BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20191231 60429-953_34d70f8f-1ec8-4fdb-82a6-393df547be7b 60429-953 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20110720 ANDA ANDA076161 Golden State Medical Supply, Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 60429-954_34d70f8f-1ec8-4fdb-82a6-393df547be7b 60429-954 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20110720 ANDA ANDA076161 Golden State Medical Supply, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 60429-955_34d70f8f-1ec8-4fdb-82a6-393df547be7b 60429-955 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20110720 ANDA ANDA076161 Golden State Medical Supply, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 60429-956_34d70f8f-1ec8-4fdb-82a6-393df547be7b 60429-956 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20110720 ANDA ANDA076161 Golden State Medical Supply, Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 60429-957_e4179a21-da5f-4a16-adc8-356f77d0f9d7 60429-957 HUMAN PRESCRIPTION DRUG Olopatadine Olopatadine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20180108 ANDA ANDA204532 Golden State Medical Supply, Inc OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20191231 60429-960_6006df06-0448-462d-b81e-7add50a6d71b 60429-960 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20171006 ANDA ANDA201408 Golden State Medical Supply, Inc. GUANFACINE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60429-961_6006df06-0448-462d-b81e-7add50a6d71b 60429-961 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20171006 ANDA ANDA201408 Golden State Medical Supply, Inc. GUANFACINE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60429-962_6006df06-0448-462d-b81e-7add50a6d71b 60429-962 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20171006 ANDA ANDA201408 Golden State Medical Supply, Inc. GUANFACINE 3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60429-963_6006df06-0448-462d-b81e-7add50a6d71b 60429-963 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20171006 ANDA ANDA201408 Golden State Medical Supply, Inc. GUANFACINE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60429-966_ce02fa78-1b5c-43ac-858d-a6f939836412 60429-966 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20180205 ANDA ANDA070791 GSMS, Incorporated DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20191231 60429-967_ce02fa78-1b5c-43ac-858d-a6f939836412 60429-967 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20180205 ANDA ANDA070791 GSMS, Incorporated DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 60429-968_ce02fa78-1b5c-43ac-858d-a6f939836412 60429-968 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20180205 ANDA ANDA070791 GSMS, Incorporated DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 60429-969_ce02fa78-1b5c-43ac-858d-a6f939836412 60429-969 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20180205 ANDA ANDA070791 GSMS, Incorporated DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20191231 60429-970_ce02fa78-1b5c-43ac-858d-a6f939836412 60429-970 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20180205 ANDA ANDA070791 GSMS, Incorporated DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20191231 60429-971_e3538891-ec42-4d59-b771-07ef299d0cb1 60429-971 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20180205 ANDA ANDA072575 GSMS, Incorporated PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 60429-972_e3538891-ec42-4d59-b771-07ef299d0cb1 60429-972 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20180205 ANDA ANDA072575 GSMS, Incorporated PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 60429-973_e3538891-ec42-4d59-b771-07ef299d0cb1 60429-973 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20180205 ANDA ANDA072575 GSMS, Incorporated PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 60429-974_9df708e0-aa16-4fad-bc1d-82a7316d24b5 60429-974 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20170915 ANDA ANDA204661 Golden State Medical Supply, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60429-975_2ebc820b-a423-46ef-8eba-9fbc93daff44 60429-975 HUMAN PRESCRIPTION DRUG IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20171017 ANDA ANDA202496 Golden State Medical Supply, Inc. IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 2.5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 60429-976_3478fb3c-6667-4214-9bc7-45c6537b02f4 60429-976 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170830 ANDA ANDA078540 Golden State Medical Supply, Inc. PROPAFENONE HYDROCHLORIDE 225 1/1 Antiarrhythmic [EPC] N 20181231 60429-982_4a78aa8d-1fe0-4df0-a15b-2350c15aead1 60429-982 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20171106 ANDA ANDA207311 Golden State Medical Supply, Inc. EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 60429-983_047b8a3b-a863-498a-b723-d7e3ad2391aa 60429-983 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate Sevelamer Carbonate TABLET, FILM COATED ORAL 20171020 ANDA ANDA206094 Golden State Medical Supply, Inc. SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 60429-984_0e7a29ed-06a4-48b1-8403-48f0fc3acaf5 60429-984 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 20180112 ANDA ANDA070173 GSMS, Incorporated DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] N 20191231 60429-985_0e7a29ed-06a4-48b1-8403-48f0fc3acaf5 60429-985 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 20180112 ANDA ANDA070174 GSMS, Incorporated DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] N 20191231 60429-989_9db4f278-499c-48df-ad7e-00bc553a8f2f 60429-989 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20180112 ANDA ANDA203807 GSMS, Incorporated CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20191231 60429-990_9db4f278-499c-48df-ad7e-00bc553a8f2f 60429-990 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20180112 ANDA ANDA203807 GSMS, Incorporated CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20191231 60432-037_b3ab88fd-e852-487c-8c75-0d85a88ac33c 60432-037 HUMAN PRESCRIPTION DRUG Lactulose Lactulose SOLUTION ORAL 19961114 ANDA ANDA074602 Morton Grove Pharmaceuticals, Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 60432-038_23a74a75-3a8b-4363-8e6d-6665ad5e4221 60432-038 HUMAN PRESCRIPTION DRUG Generlac Lactulose SOLUTION ORAL 19961031 ANDA ANDA074603 Morton Grove Pharmaceuticals, Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 60432-065_3c560023-8419-482c-869f-615e13dd7ce3 60432-065 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20081125 ANDA ANDA065431 Morton Grove Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 250; 62.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 60432-070_e6881bee-9831-4cd0-a498-7eb67cdf283b 60432-070 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION ORAL 20131202 ANDA ANDA065420 Morton Grove Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 60432-092_da22ff0d-ab08-432a-8cf0-3cb9d0b251b9 60432-092 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride SYRUP ORAL 19970212 ANDA ANDA074868 Morton Grove Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 5 mg/5mL Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 60432-093_e85e665f-98ed-4405-b9d8-6773354e66d2 60432-093 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride AMANTADINE HYDROCHLORIDE SOLUTION ORAL 19981224 ANDA ANDA075060 Morton Grove Pharmaceuticals, Inc. AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 60432-126_4e4d6211-682e-4357-b75b-b4894c5d8f54 60432-126 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20050209 ANDA ANDA076721 Morton Grove Pharmaceuticals, Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 60432-129_562e7ad2-02e7-444d-bf2f-5c20d2a081f3 60432-129 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE carbamazepine SUSPENSION ORAL 20020605 ANDA ANDA075714 Morton Grove Pharmaceuticals, Inc. CARBAMAZEPINE 100 mg/5mL Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 60432-131_5842e34a-9a0c-44d0-8ff7-47e59cfcb407 60432-131 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20020624 ANDA ANDA040420 Morton Grove Pharmaceuticals, Inc. PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 60432-133_ef205af0-967e-40f1-b83e-2cd5e1a52dca 60432-133 HUMAN PRESCRIPTION DRUG Clobetasol Propionate CLOBETASOL PROPIONATE SOLUTION TOPICAL 19981113 ANDA ANDA075205 Morton Grove Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60432-150_0f000665-d889-42e3-a710-5c399f066ea7 60432-150 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride SYRUP ORAL 19950309 ANDA ANDA087294 Morton Grove Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 60432-212_77f47006-eaee-4152-9095-de097e4aedc1 60432-212 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20041004 ANDA ANDA076895 Morton Grove Pharmaceuticals, Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60432-245_e7303c21-ba5d-42f5-a9e6-881c3966bd0b 60432-245 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate acetaminophen and codeine phosphate SOLUTION ORAL 19810722 ANDA ANDA087006 Morton Grove Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 60432-264_b63d818a-442d-4abc-b83d-b7d212f82740 60432-264 HUMAN PRESCRIPTION DRUG Fluticasone Fluticasone Propionate SPRAY, METERED NASAL 20120109 ANDA ANDA078492 Morton Grove Pharmaceuticals, Inc. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60432-275_561eab3c-f80c-436a-884a-de8c42ce253a 60432-275 HUMAN PRESCRIPTION DRUG Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide SYRUP ORAL 20100615 ANDA ANDA088811 Morton Grove Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 2; 30; 10 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] N 20181231 60432-455_11720d96-9d05-4a72-809b-ff2143c38491 60432-455 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide hydrocodone bitartrate and homatropine methylbromide SYRUP ORAL 19830303 ANDA ANDA088008 Morton Grove Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 60432-464_6bae7856-e5e8-4cb2-97e4-3f2813350779 60432-464 HUMAN PRESCRIPTION DRUG LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride SOLUTION TOPICAL 19821118 ANDA ANDA087872 Morton Grove Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 60432-465_3c405273-1bb6-4ff2-986a-481c88e12002 60432-465 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 19821118 ANDA ANDA087881 Morton Grove Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 60432-466_e8202cfa-3622-4d7c-a999-162ba3139af9 60432-466 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone ELIXIR ORAL 19830727 ANDA ANDA088254 Morton Grove Pharmaceuticals, Inc. DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60432-528_4d6ce523-559e-4f79-a007-8be16b405423 60432-528 HUMAN PRESCRIPTION DRUG Selenium Sulfide Selenium Sulfide LOTION TOPICAL 19830901 ANDA ANDA088228 Morton Grove Pharmaceuticals, Inc. SELENIUM SULFIDE 25 mg/mL N 20181231 60432-537_e7a77b34-4524-4b0b-b014-fa66271042f6 60432-537 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 19950415 ANDA ANDA062512 Morton Grove Pharmaceuticals, Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 60432-560_47121b80-2218-41c2-bd76-70e945fb8d9b 60432-560 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE LOTION TOPICAL 19850401 ANDA ANDA088450 Morton Grove Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE .25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60432-561_44e205df-1296-452a-a985-e01b40343af8 60432-561 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide LOTION TOPICAL 19850403 ANDA ANDA088451 Morton Grove Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60432-604_d1c938a2-b20a-47d3-aa32-c8cf4338b7cd 60432-604 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide promethazine hydrochloride and dextromethorphan hydrobromide SYRUP ORAL 19850104 ANDA ANDA088864 Morton Grove Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 60432-606_874a09f5-9340-4f84-afd4-5f87eff49a8c 60432-606 HUMAN PRESCRIPTION DRUG Promethazine with Codeine promethazine hydrochloride and codeine phosphate SOLUTION ORAL 19841217 ANDA ANDA088875 Morton Grove Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 60432-608_94a74bdc-b864-44f2-aa36-59a74d916ed8 60432-608 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride SYRUP ORAL 19821115 ANDA ANDA087953 Morton Grove Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 60432-613_a4c73672-cf91-4485-8891-5556d0dde4b2 60432-613 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 19871002 ANDA ANDA070655 Morton Grove Pharmaceuticals, Inc. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 60432-621_1da9023e-44f6-474a-9756-6244b1d3088f 60432-621 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 19860701 ANDA ANDA070868 Morton Grove Pharmaceuticals, Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 60432-651_16ccdc71-955e-41a7-bd5e-12cd042c853b 60432-651 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride SOLUTION ORAL 19950209 ANDA ANDA071918 Morton Grove Pharmaceuticals, Inc. DOXEPIN HYDROCHLORIDE 10 mg/mL Tricyclic Antidepressant [EPC] N 20181231 60432-671_ea1803d1-a0ae-486e-8077-478586fdcf62 60432-671 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ERYTHROMYCIN SOLUTION TOPICAL 19871023 ANDA ANDA062825 Morton Grove Pharmaceuticals, Inc. ERYTHROMYCIN 20 mg/mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 60432-706_a3dfab67-8001-44f6-98db-f8ab9fe5d12e 60432-706 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride oxycodone hydrochloride SOLUTION ORAL 20150617 ANDA ANDA206456 Morton Grove Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60432-741_113855e5-635a-4243-8817-a1d0c2720fa3 60432-741 HUMAN PRESCRIPTION DRUG ACETIC ACID Acetic Acid SOLUTION AURICULAR (OTIC) 19960726 ANDA ANDA040166 Morton Grove Pharmaceuticals, Inc. ACETIC ACID 20 mg/mL N 20181231 60432-831_44addcbc-4269-416b-9c1c-70ccf51785d4 60432-831 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20100318 ANDA ANDA090028 Morton Grove Pharmaceuticals, Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60432-834_3de32784-ce56-4a8e-8db8-c479aceb6c19 60432-834 HUMAN PRESCRIPTION DRUG Lindane Lindane SHAMPOO TOPICAL 19941212 ANDA ANDA088191 Morton Grove Pharmaceuticals, Inc. LINDANE 10 mg/mL N 20181231 60432-837_93dd96c4-8569-4d3a-acab-456595704a81 60432-837 HUMAN PRESCRIPTION DRUG Bromfed DM brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide SYRUP ORAL 20100615 ANDA ANDA088811 Morton Grove Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 2; 30; 10 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] N 20181231 60456-576_6ddbe8e7-e68f-463f-94e5-2b0616de5496 60456-576 HUMAN OTC DRUG Antibacterial Foamy Mango TRICLOSAN SOAP TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part333E Carpet Rentals, Inc. TRICLOSAN 3 mg/mL E 20171231 60456-876_73966fbc-3f34-4632-b015-8d4201145eaf 60456-876 HUMAN OTC DRUG Antibacterial Foamy Mango High Foaming Antiseptic Hand and Body Wash CHLOROXYLENOL SOAP TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Carpet Rentals, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 60492-0075_917691ee-4d8b-468f-8cc5-b64c0688e4ae 60492-0075 PLASMA DERIVATIVE BAT Botulism Antitoxin Heptavalent LIQUID INTRAVENOUS 20130301 BLA BLA125462 Cangene Corporation EQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN B IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN C IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN D IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN E IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN F IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN G IMMUNE FAB2 4500; 3300; 3000; 600; 5100; 3000; 600 [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL N 20181231 60492-0173_0e0c62af-eeab-4de9-9514-9210ad25c3a1 60492-0173 HUMAN PRESCRIPTION DRUG CNJ-016 Vaccinia Immune Globulin (Human) INJECTION INTRAVENOUS 20050502 BLA BLA125109 Cangene Corporation HUMAN VACCINIA VIRUS IMMUNE GLOBULIN 1 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] N 20181231 60492-0249_97cc9a89-6fe0-424e-82d1-0cf9d19444db 60492-0249 PLASMA DERIVATIVE Anthrasil Anthrax immune globulin (human) LIQUID INTRAVENOUS 20151005 BLA BLA125562 Cangene Corporation ANTHRAX IMMUNE GLOBULIN HUMAN 60 [iU]/35mL N 20181231 60505-0003_b906308c-aa07-ade5-045b-1b45f8bb0a9a 60505-0003 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 20051207 ANDA ANDA074737 Apotex Corp. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60505-0004_b906308c-aa07-ade5-045b-1b45f8bb0a9a 60505-0004 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 20051207 ANDA ANDA074737 Apotex Corp. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60505-0005_b906308c-aa07-ade5-045b-1b45f8bb0a9a 60505-0005 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 20051207 ANDA ANDA074737 Apotex Corp. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60505-0006_b906308c-aa07-ade5-045b-1b45f8bb0a9a 60505-0006 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 20051207 ANDA ANDA074737 Apotex Corp. CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60505-0014_42734f3c-3282-78ce-faf9-285d34ec8e99 60505-0014 HUMAN PRESCRIPTION DRUG DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20010730 ANDA ANDA074943 Apotex Corp. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 60505-0015_42734f3c-3282-78ce-faf9-285d34ec8e99 60505-0015 HUMAN PRESCRIPTION DRUG DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20010730 ANDA ANDA074943 Apotex Corp. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 60505-0016_42734f3c-3282-78ce-faf9-285d34ec8e99 60505-0016 HUMAN PRESCRIPTION DRUG DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20010730 ANDA ANDA074943 Apotex Corp. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 60505-0025_4501ec41-0a9f-b4bf-43cb-40916ce796bf 60505-0025 HUMAN PRESCRIPTION DRUG Ranitidine ranitidine hydrochloride TABLET, FILM COATED ORAL 19970913 ANDA ANDA074680 Apotex Corp RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 60505-0026_4501ec41-0a9f-b4bf-43cb-40916ce796bf 60505-0026 HUMAN PRESCRIPTION DRUG Ranitidine ranitidine hydrochloride TABLET, FILM COATED ORAL 19970913 ANDA ANDA074680 Apotex Corp RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 60505-0027_072b86f7-4a22-d3b2-ca03-8edd6bc1c128 60505-0027 HUMAN PRESCRIPTION DRUG Ticlopidine hydrochloride Ticlopidine hydrochloride TABLET, FILM COATED ORAL 19990701 ANDA ANDA075089 Apotex Corp. TICLOPIDINE HYDROCHLORIDE 250 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 60505-0033_4915379d-9d57-664c-4b60-644ff8d8e3b7 60505-0033 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 19990610 ANDA ANDA075191 Apotex Corp. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 60505-0034_4d44759f-d224-6810-28d8-0ce627d3c3c4 60505-0034 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19981001 ANDA ANDA075034 Apotex Corp. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 60505-0039_4c323984-1cfc-9254-03fe-083506cb663f 60505-0039 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20030501 ANDA ANDA075419 Apotex Corp. ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60505-0040_4c323984-1cfc-9254-03fe-083506cb663f 60505-0040 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20030501 ANDA ANDA075419 Apotex Corp. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60505-0041_88dc5816-2639-0e19-2652-2f6244218d90 60505-0041 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20030501 ANDA ANDA076004 Apotex Corp. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60505-0042_b00bb41b-b97d-0300-9e2a-91eead425d42 60505-0042 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20060320 ANDA ANDA075677 Apotex Corp. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60505-0055_db021527-0e05-e1a3-f9a8-4ad4a4ce9848 60505-0055 HUMAN PRESCRIPTION DRUG SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE CAPSULE ORAL 19970715 ANDA ANDA075321 Apotex Corp. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 60505-0065_1fcb39a7-e54c-096d-9d28-f86bd0eca8bb 60505-0065 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Apotex Corp OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60505-0080_b02d79b3-6f22-e922-ca72-1b2662fb5bef 60505-0080 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Apotex Corp. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 60505-0081_b02d79b3-6f22-e922-ca72-1b2662fb5bef 60505-0081 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Apotex Corp. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 60505-0082_b02d79b3-6f22-e922-ca72-1b2662fb5bef 60505-0082 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Apotex Corp. SOTALOL HYDROCHLORIDE 240 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 60505-0083_76ac1282-7bc6-1b93-0e72-d714dda8406f 60505-0083 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Apotex Corp. PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-0084_76ac1282-7bc6-1b93-0e72-d714dda8406f 60505-0084 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Apotex Corp. PAROXETINE HYDROCHLORIDE ANHYDROUS 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-0093_00a491e9-db73-2e60-a972-8e1504a34dac 60505-0093 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Apotex Corp. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 60505-0094_00a491e9-db73-2e60-a972-8e1504a34dac 60505-0094 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Apotex Corp. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 60505-0095_00a491e9-db73-2e60-a972-8e1504a34dac 60505-0095 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Apotex Corp. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 60505-0096_00a491e9-db73-2e60-a972-8e1504a34dac 60505-0096 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Apotex Corp. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 60505-0097_76ac1282-7bc6-1b93-0e72-d714dda8406f 60505-0097 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Apotex Corp. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-0101_76ac1282-7bc6-1b93-0e72-d714dda8406f 60505-0101 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Apotex Corp. PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-0102_88dc5816-2639-0e19-2652-2f6244218d90 60505-0102 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20030501 ANDA ANDA076004 Apotex Corp. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60505-0112_6fecc264-9e9f-8c24-9f6b-3ae3cf699d82 60505-0112 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Apotex Corp. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60505-0113_6fecc264-9e9f-8c24-9f6b-3ae3cf699d82 60505-0113 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Apotex Corp. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60505-0114_6fecc264-9e9f-8c24-9f6b-3ae3cf699d82 60505-0114 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Apotex Corp. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60505-0128_5426d2c2-d5c0-6ea0-404c-35e57f695b27 60505-0128 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20081009 ANDA ANDA077120 Apotex Corp. CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 60505-0129_5426d2c2-d5c0-6ea0-404c-35e57f695b27 60505-0129 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20081009 ANDA ANDA077120 Apotex Corp. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 60505-0130_5426d2c2-d5c0-6ea0-404c-35e57f695b27 60505-0130 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20081009 ANDA ANDA077120 Apotex Corp. CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 60505-0133_420f6433-57b5-8465-c680-ee6e6af6182f 60505-0133 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, GELATIN COATED ORAL 20020529 ANDA ANDA065040 Apotex Corp. CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 60505-0134_420f6433-57b5-8465-c680-ee6e6af6182f 60505-0134 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, GELATIN COATED ORAL 20020529 ANDA ANDA065040 Apotex Corp. CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 60505-0141_b7518725-26fc-8e51-a542-70f293431c49 60505-0141 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 Apotex Corp. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 60505-0142_b7518725-26fc-8e51-a542-70f293431c49 60505-0142 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 Apotex Corp. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 60505-0145_1fcb39a7-e54c-096d-9d28-f86bd0eca8bb 60505-0145 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Apotex Corp OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60505-0146_1fcb39a7-e54c-096d-9d28-f86bd0eca8bb 60505-0146 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA076048 Apotex Corp OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60505-0147_f7bcba81-8eed-c97f-a6c7-84f7a82b1e1e 60505-0147 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20050124 ANDA ANDA076471 Apotex Corp. LORATADINE 10 mg/1 N 20181231 60505-0157_b962c356-b096-b00d-c796-7995540652fc 60505-0157 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 Apotex Corp BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60505-0158_b962c356-b096-b00d-c796-7995540652fc 60505-0158 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 Apotex Corp BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60505-0159_b02d79b3-6f22-e922-ca72-1b2662fb5bef 60505-0159 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Apotex Corp. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 60505-0160_f8372986-43c9-5048-278e-700e2aa6dd91 60505-0160 HUMAN OTC DRUG Ranitidine Ranitidine hydrochloride TABLET, FILM COATED ORAL 20161222 ANDA ANDA075167 Apotex Corp. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 60505-0164_786619e3-dd1c-bc85-f812-d12cd664c67f 60505-0164 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20010710 ANDA ANDA075902 Apotex Corp FLUVOXAMINE MALEATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-0165_786619e3-dd1c-bc85-f812-d12cd664c67f 60505-0165 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20010710 ANDA ANDA075902 Apotex Corp FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-0166_786619e3-dd1c-bc85-f812-d12cd664c67f 60505-0166 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET ORAL 20010710 ANDA ANDA075902 Apotex Corp FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-0168_7cac6995-5557-9093-1585-e96ede93b85d 60505-0168 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Apotex Corp. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60505-0169_7cac6995-5557-9093-1585-e96ede93b85d 60505-0169 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Apotex Corp. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60505-0170_7cac6995-5557-9093-1585-e96ede93b85d 60505-0170 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Apotex Corp. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60505-0176_0233b5cb-b292-09d4-665e-a123c0d970f1 60505-0176 HUMAN PRESCRIPTION DRUG oxaprozin oxaprozin TABLET, FILM COATED ORAL 20040903 ANDA ANDA075987 Apotex Corp. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60505-0183_2ec621fc-6627-0954-9680-7a5d6445982d 60505-0183 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20020901 ANDA ANDA075948 Apotex Corp. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 60505-0190_b5f823b9-f4d8-a7af-95e2-b3f481e0abca 60505-0190 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20111207 ANDA ANDA090666 Apotex Corp. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60505-0191_b5f823b9-f4d8-a7af-95e2-b3f481e0abca 60505-0191 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20111207 ANDA ANDA090666 Apotex Corp. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60505-0192_b5f823b9-f4d8-a7af-95e2-b3f481e0abca 60505-0192 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20111207 ANDA ANDA090666 Apotex Corp. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60505-0193_eed6e684-2ddd-68c9-9e6a-d7edc15e9d7c 60505-0193 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070524 ANDA ANDA076719 Apotex Corp. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60505-0194_eed6e684-2ddd-68c9-9e6a-d7edc15e9d7c 60505-0194 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070524 ANDA ANDA076719 Apotex Corp. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60505-0195_eed6e684-2ddd-68c9-9e6a-d7edc15e9d7c 60505-0195 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070524 ANDA ANDA076719 Apotex Corp. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60505-0222_35d9821e-208d-0e8c-ce86-6c699ac5fe5e 60505-0222 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030909 ANDA ANDA076214 Apotex Corp. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 60505-0223_35d9821e-208d-0e8c-ce86-6c699ac5fe5e 60505-0223 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030909 ANDA ANDA076214 Apotex Corp. SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 60505-0224_35d9821e-208d-0e8c-ce86-6c699ac5fe5e 60505-0224 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030909 ANDA ANDA076214 Apotex Corp. SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 60505-0232_8b97f959-0d5f-963b-1dd0-eb50784fa87a 60505-0232 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20050606 ANDA ANDA076894 Apotex Corp. TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 60505-0233_8b97f959-0d5f-963b-1dd0-eb50784fa87a 60505-0233 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20050606 ANDA ANDA076894 Apotex Corp. TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 60505-0234_8b97f959-0d5f-963b-1dd0-eb50784fa87a 60505-0234 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20050606 ANDA ANDA076894 Apotex Corp. TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 60505-0235_8b97f959-0d5f-963b-1dd0-eb50784fa87a 60505-0235 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20050606 ANDA ANDA076894 Apotex Corp. TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 60505-0247_c6126845-fa97-b7c2-beaf-e57bb40822e3 60505-0247 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Apotex Corp. MIRTAZAPINE 15 mg/1 N 20181231 60505-0248_c6126845-fa97-b7c2-beaf-e57bb40822e3 60505-0248 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Apotex Corp. MIRTAZAPINE 30 mg/1 N 20181231 60505-0249_c6126845-fa97-b7c2-beaf-e57bb40822e3 60505-0249 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Apotex Corp. MIRTAZAPINE 45 mg/1 N 20181231 60505-0251_ab53e59a-c8a3-c8b8-09dc-5a924240404e 60505-0251 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Apotex Corp. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60505-0252_ab53e59a-c8a3-c8b8-09dc-5a924240404e 60505-0252 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Apotex Corp. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60505-0253_55c3a99a-a1d2-57a8-40fd-bd533833a697 60505-0253 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076274 Apotex Corp. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 60505-0257_70e03df9-a7ad-ea1f-2e66-38a29bc94b0e 60505-0257 HUMAN PRESCRIPTION DRUG Desmopressin Acetate desmopressin acetate TABLET ORAL 20060307 ANDA ANDA077414 Apotex Corp. DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 60505-0258_70e03df9-a7ad-ea1f-2e66-38a29bc94b0e 60505-0258 HUMAN PRESCRIPTION DRUG Desmopressin Acetate desmopressin acetate TABLET ORAL 20060307 ANDA ANDA077414 Apotex Corp. DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 60505-0260_b5f823b9-f4d8-a7af-95e2-b3f481e0abca 60505-0260 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20041216 ANDA ANDA076706 Apotex Corp. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60505-0261_c5cff553-1b6e-0f0c-d0e3-06ebb5c6bf81 60505-0261 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140821 ANDA ANDA078794 Apotex Corp. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-0262_c5cff553-1b6e-0f0c-d0e3-06ebb5c6bf81 60505-0262 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140821 ANDA ANDA078794 Apotex Corp. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-0263_c5cff553-1b6e-0f0c-d0e3-06ebb5c6bf81 60505-0263 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140821 ANDA ANDA078794 Apotex Corp. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-0264_c5cff553-1b6e-0f0c-d0e3-06ebb5c6bf81 60505-0264 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140821 ANDA ANDA078794 Apotex Corp. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-0265_989b9fc4-9705-c40f-cfc5-e10510ce467f 60505-0265 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20060416 ANDA ANDA077128 Apotex Corp BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60505-0266_989b9fc4-9705-c40f-cfc5-e10510ce467f 60505-0266 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20060416 ANDA ANDA077128 Apotex Corp BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60505-0267_989b9fc4-9705-c40f-cfc5-e10510ce467f 60505-0267 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20060421 ANDA ANDA077128 Apotex Corp BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60505-0268_989b9fc4-9705-c40f-cfc5-e10510ce467f 60505-0268 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20060421 ANDA ANDA077128 Apotex Corp BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60505-0271_1ae4641b-de57-eb08-42ba-c5b0870891f2 60505-0271 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET ORAL 20080609 ANDA ANDA078454 Apotex Corp. MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60505-0272_1ae4641b-de57-eb08-42ba-c5b0870891f2 60505-0272 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET ORAL 20080609 ANDA ANDA078454 Apotex Corp. MOEXIPRIL HYDROCHLORIDE 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60505-0363_3e4a3dc8-8e55-cc6e-6fb1-3796147f4607 60505-0363 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20040514 ANDA ANDA076527 Apotex Corp. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 60505-0399_e8159243-e6fd-e038-7cb4-cdefd14d850b 60505-0399 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20140528 ANDA ANDA202027 Apotex Corp. DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60505-0402_cae3423b-8bc3-ea9a-4ce9-f73ca4fa2c6d 60505-0402 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride SUSPENSION ORAL 20110101 NDA NDA020710 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-0403_aa8195d8-ecb0-dedb-14ae-32ed9b60dea6 60505-0403 HUMAN PRESCRIPTION DRUG LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION ORAL 20171026 ANDA ANDA202915 Apotex Corp. LEVOCETIRIZINE DIHYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 60505-0404_689fa4e2-e804-cf18-75f0-6fff031725e1 60505-0404 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole SOLUTION ORAL 20151008 ANDA ANDA204094 Apotex Corp. ARIPIPRAZOLE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 60505-0501_0048a497-1429-5adc-88b7-c0625f37e48b 60505-0501 HUMAN PRESCRIPTION DRUG Imiquimod imiquimod CREAM TOPICAL 20120914 ANDA ANDA091308 Apotex Corp. IMIQUIMOD 50 mg/1000mg Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] N 20181231 60505-0575_aaee5e13-ddd8-52ad-3dfb-ce9fd20aaba6 60505-0575 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride Olopatadine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20151207 ANDA ANDA078350 Apotex Corp. OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 60505-0578_d8e0678b-d4ce-8d44-2706-ed4db51121c9 60505-0578 HUMAN PRESCRIPTION DRUG AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE SOLUTION/ DROPS INTRAOCULAR 20091201 ANDA ANDA078621 Apotex Corp. AZELASTINE HYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 60505-0582_b6991656-3016-897e-dbde-ac82ccea6043 60505-0582 HUMAN PRESCRIPTION DRUG Moxifloxacin moxifloxacin SOLUTION/ DROPS OPHTHALMIC 20170701 ANDA ANDA090080 Apotex Corp. MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 60505-0584_ccead7b6-56a5-9920-0911-66fda4d24ac6 60505-0584 HUMAN PRESCRIPTION DRUG Epinastine Hydrochloride Epinastine Hydrochloride SOLUTION OPHTHALMIC 20111031 ANDA ANDA090919 Apotex Corp. EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 60505-0586_d1989bcf-ae19-aada-9e14-52025df774ce 60505-0586 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride Olopatadine Hydrochloride SOLUTION OPHTHALMIC 20171121 ANDA ANDA090918 Apotex Corp. OLOPATADINE HYDROCHLORIDE 2 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 60505-0597_45c57114-5f79-4d70-9423-7b87fb554971 60505-0597 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20110715 ANDA ANDA077259 Apotex Corp. TIMOLOL MALEATE 2.5 mg/mL N 20181231 60505-0598_45c57114-5f79-4d70-9423-7b87fb554971 60505-0598 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20110715 ANDA ANDA077259 Apotex Corp. TIMOLOL MALEATE 5 mg/mL N 20181231 60505-0679_f8d06e82-2b93-487b-9c94-3a9a2057fd9e 60505-0679 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20050802 ANDA ANDA065232 Apotex Corporation CEFTRIAXONE SODIUM 100 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0681_bac7dbb3-2751-4c30-946c-308bf4306b64 60505-0681 HUMAN PRESCRIPTION DRUG CEFEPIME Cefepime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070618 ANDA ANDA065369 Apotex Corporation CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0686_c3f97516-25d9-43f7-8f95-6a06fe6f70bf 60505-0686 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN and TAZOBACTAM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090921 ANDA ANDA065386 Apotex Corporation PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 60505-0687_c3f97516-25d9-43f7-8f95-6a06fe6f70bf 60505-0687 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN and TAZOBACTAM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090921 ANDA ANDA065386 Apotex Corporation PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 60505-0688_c3f97516-25d9-43f7-8f95-6a06fe6f70bf 60505-0688 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN and TAZOBACTAM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20090921 ANDA ANDA065386 Apotex Corporation PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 60505-0748_47b3b4ba-20fe-4901-9873-9479c5deea2d 60505-0748 HUMAN PRESCRIPTION DRUG Cefazolin CEFAZOLIN INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051007 ANDA ANDA065226 Apotex Corporation CEFAZOLIN SODIUM 500 mg/2.2mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0749_47b3b4ba-20fe-4901-9873-9479c5deea2d 60505-0749 HUMAN PRESCRIPTION DRUG Cefazolin CEFAZOLIN INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051007 ANDA ANDA065226 Apotex Corporation CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0750_5d2312df-3a80-4327-aa71-1d4ffc31972b 60505-0750 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0751_5d2312df-3a80-4327-aa71-1d4ffc31972b 60505-0751 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0752_5d2312df-3a80-4327-aa71-1d4ffc31972b 60505-0752 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0753_5d2312df-3a80-4327-aa71-1d4ffc31972b 60505-0753 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0759_1defad78-8fd6-49e8-9587-51717097911a 60505-0759 HUMAN PRESCRIPTION DRUG Cefoxitin CEFOXITIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060213 ANDA ANDA065313 Apotex Corporation CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0760_1defad78-8fd6-49e8-9587-51717097911a 60505-0760 HUMAN PRESCRIPTION DRUG Cefoxitin CEFOXITIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060213 ANDA ANDA065313 Apotex Corporation CEFOXITIN SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0761_53315e04-f9a3-41cc-be4e-73f12c5476c0 60505-0761 HUMAN PRESCRIPTION DRUG Cefoxitin CEFOXITIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060213 ANDA ANDA065312 Apotex Corporation CEFOXITIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0769_b6f52e59-d3d5-4264-8466-d0eb260c5c5b 60505-0769 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060613 ANDA ANDA065247 Apotex Corporation CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0773_b95599a4-faf0-449f-98f8-146a3c08a91d 60505-0773 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN and TAZOBACTAM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091005 ANDA ANDA065446 Apotex Corporation PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 36; 4.5 g/152mL; g/152mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 60505-0813_5da6ab4d-8851-2c93-de9c-4e5d1f09710b 60505-0813 HUMAN PRESCRIPTION DRUG Butorphanol Tartrate Butorphanol Tartrate SPRAY NASAL 20021204 ANDA ANDA075499 Apotex Corp. BUTORPHANOL TARTRATE 10 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] CIV N 20181231 60505-0820_9db90eb8-7c60-e73a-a8e2-12d304550c45 60505-0820 HUMAN PRESCRIPTION DRUG BUDESONIDE BUDESONIDE SUSPENSION RESPIRATORY (INHALATION) 20090330 ANDA ANDA078202 Apotex Corp. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60505-0821_9db90eb8-7c60-e73a-a8e2-12d304550c45 60505-0821 HUMAN PRESCRIPTION DRUG BUDESONIDE BUDESONIDE SUSPENSION RESPIRATORY (INHALATION) 20090330 ANDA ANDA078202 Apotex Corp. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60505-0823_78afdd54-08c7-93f8-113b-9eb08a7b603c 60505-0823 HUMAN PRESCRIPTION DRUG Calcitonin Salmon Calcitonin Salmon SPRAY, METERED NASAL 20081209 ANDA ANDA076396 Apotex Corp. CALCITONIN SALMON 200 [iU]/1 Calcitonin [Chemical/Ingredient],Calcitonin [EPC] N 20181231 60505-0829_adbe1781-7c60-3f0e-3f12-993e221c5d1f 60505-0829 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20070919 ANDA ANDA077538 Apotex Corp. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60505-0830_a29cdc1b-51c8-f9f7-21b9-a2326602644a 60505-0830 HUMAN PRESCRIPTION DRUG MOMETASONE FUROATE MOMETASONE FUROATE SPRAY, METERED NASAL 20160322 ANDA ANDA091161 Apotex Corp. MOMETASONE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60505-0833_5377f4dc-f07b-70e7-6bc4-ad49c5b59c8b 60505-0833 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride azelastine hydrochloride SPRAY, METERED NASAL 20100301 ANDA ANDA077954 Apotex Corp. AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 60505-0834_bac7dbb3-2751-4c30-946c-308bf4306b64 60505-0834 HUMAN PRESCRIPTION DRUG CEFEPIME Cefepime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070618 ANDA ANDA065369 Apotex Corporation CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-0839_d98ba7b4-65f6-e280-4081-9da5398f8fb5 60505-0839 HUMAN PRESCRIPTION DRUG Budesonide Nasal Budesonide SPRAY, METERED NASAL 20140512 ANDA ANDA078949 Apotex Corp. BUDESONIDE 32 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60505-0845_255fefaa-5e06-2a06-600d-2dbf6e11ac2c 60505-0845 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride olopatadine hydrochloride SPRAY, METERED NASAL 20141027 ANDA ANDA091572 Apotex Corp. OLOPATADINE HYDROCHLORIDE 665 ug/1 Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 60505-0847_2aeaff00-df25-15dd-7af3-ffbea99c39e5 60505-0847 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20070919 ANDA ANDA077538 Apotex Corp. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60505-0848_43f27206-9b6a-bbff-1f40-37347340fadd 60505-0848 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine Hydrochloride SPRAY, METERED NASAL 20140707 ANDA ANDA201846 Apotex Corp. AZELASTINE HYDROCHLORIDE 205.5 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 60505-0955_f96d6003-4b1b-f444-5e40-fe6db41ff197 60505-0955 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20170725 ANDA ANDA208150 Apotex Corp. FLUTICASONE PROPIONATE 50 ug/1 N 20181231 60505-1003_21afb860-7fad-3b22-77c0-8a96b2dacbd7 60505-1003 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION/ DROPS OPHTHALMIC 20091207 ANDA ANDA076109 Apotex Corp. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 60505-1005_a114ca24-a075-87ed-3f39-5dc419e3c745 60505-1005 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20171116 ANDA ANDA204936 Apotex Corp TIMOLOL MALEATE 6.8 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60505-1308_6c46810f-2753-e9a8-c228-01c7c7443a7c 60505-1308 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20050419 ANDA ANDA076896 Apotex Corp CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 60505-1309_6c46810f-2753-e9a8-c228-01c7c7443a7c 60505-1309 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20050419 ANDA ANDA076896 Apotex Corp CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 60505-1310_6c46810f-2753-e9a8-c228-01c7c7443a7c 60505-1310 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20080313 ANDA ANDA076896 Apotex Corp CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 60505-1320_0134b671-43c9-2ae7-de78-a72bc87e3297 60505-1320 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20060912 ANDA ANDA077746 Apotex Corp MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 60505-1321_0134b671-43c9-2ae7-de78-a72bc87e3297 60505-1321 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20060912 ANDA ANDA077746 Apotex Corp MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 60505-1323_7cac6995-5557-9093-1585-e96ede93b85d 60505-1323 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 Apotex Corp. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60505-1325_0134b671-43c9-2ae7-de78-a72bc87e3297 60505-1325 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride Midodrine Hydrochloride TABLET ORAL 20060912 ANDA ANDA077746 Apotex Corp MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 60505-1329_b5f823b9-f4d8-a7af-95e2-b3f481e0abca 60505-1329 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20051229 ANDA ANDA076706 Apotex Corp. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60505-1331_fae1359b-249a-eef2-4b01-4a442a945ccb 60505-1331 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070119 ANDA ANDA077741 Apotex Corp. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60505-1332_fae1359b-249a-eef2-4b01-4a442a945ccb 60505-1332 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070119 ANDA ANDA077741 Apotex Corp. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60505-1333_fae1359b-249a-eef2-4b01-4a442a945ccb 60505-1333 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070119 ANDA ANDA077741 Apotex Corp. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60505-1334_fae1359b-249a-eef2-4b01-4a442a945ccb 60505-1334 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070119 ANDA ANDA077741 Apotex Corp. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60505-2502_53942ac4-8107-ff92-6096-b1b606d70fd7 60505-2502 HUMAN PRESCRIPTION DRUG LEFLUNOMIDE LEFLUNOMIDE TABLET ORAL 20050913 ANDA ANDA077090 Apotex Corp. LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] N 20181231 60505-2503_53942ac4-8107-ff92-6096-b1b606d70fd7 60505-2503 HUMAN PRESCRIPTION DRUG LEFLUNOMIDE LEFLUNOMIDE TABLET ORAL 20050913 ANDA ANDA077090 Apotex Corp. LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] N 20181231 60505-2518_7f19cea3-6e75-5cd2-73eb-2b32919dfb77 60505-2518 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20110801 ANDA ANDA077046 Apotex Corp. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-2519_7f19cea3-6e75-5cd2-73eb-2b32919dfb77 60505-2519 HUMAN PRESCRIPTION DRUG Citalopram citalopram hydrobromide TABLET, FILM COATED ORAL 20110801 ANDA ANDA077046 Apotex Corp. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-2520_7f19cea3-6e75-5cd2-73eb-2b32919dfb77 60505-2520 HUMAN PRESCRIPTION DRUG Citalopram citalopram hydrobromide TABLET, FILM COATED ORAL 20110801 ANDA ANDA077046 Apotex Corp. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-2521_71415cf1-76bb-4674-8620-fc4c20a971dd 60505-2521 HUMAN PRESCRIPTION DRUG cilostazol cilostazol TABLET ORAL 20111018 ANDA ANDA077030 Apotex Corp. CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 60505-2522_71415cf1-76bb-4674-8620-fc4c20a971dd 60505-2522 HUMAN PRESCRIPTION DRUG cilostazol cilostazol TABLET ORAL 20111018 ANDA ANDA077030 Apotex Corp. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 60505-2526_a8d0fa87-d313-3376-05ec-bdca9e72d44a 60505-2526 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20140203 ANDA ANDA077667 Apotex Corp. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 60505-2527_a8d0fa87-d313-3376-05ec-bdca9e72d44a 60505-2527 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20140203 ANDA ANDA077667 Apotex Corp. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 60505-2528_1a834867-8af2-6682-47ef-0bee84565600 60505-2528 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Apotex Corp. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2529_1a834867-8af2-6682-47ef-0bee84565600 60505-2529 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Apotex Corp. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2530_1a834867-8af2-6682-47ef-0bee84565600 60505-2530 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Apotex Corp. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2531_1a834867-8af2-6682-47ef-0bee84565600 60505-2531 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Apotex Corp. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2532_184a86fe-c907-9598-6d7e-c94a542ec44d 60505-2532 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20080509 ANDA ANDA065327 Apotex Corp CEFPROZIL 250 mg/1 N 20181231 60505-2533_184a86fe-c907-9598-6d7e-c94a542ec44d 60505-2533 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20080509 ANDA ANDA065327 Apotex Corp CEFPROZIL 500 mg/1 N 20181231 60505-2542_bbb8e919-8ec1-5fc3-9f64-054d3fa02dde 60505-2542 HUMAN PRESCRIPTION DRUG Galantamine galantamine hydrobromide TABLET, FILM COATED ORAL 20121105 ANDA ANDA077781 Apotex Corp. GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60505-2543_bbb8e919-8ec1-5fc3-9f64-054d3fa02dde 60505-2543 HUMAN PRESCRIPTION DRUG Galantamine galantamine hydrobromide TABLET, FILM COATED ORAL 20121105 ANDA ANDA077781 Apotex Corp. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60505-2544_bbb8e919-8ec1-5fc3-9f64-054d3fa02dde 60505-2544 HUMAN PRESCRIPTION DRUG Galantamine galantamine hydrobromide TABLET, FILM COATED ORAL 20121105 ANDA ANDA077781 Apotex Corp. GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60505-2545_00002548-0fd8-1896-bd20-330125084756 60505-2545 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077642 Apotex Corp. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 60505-2546_00002548-0fd8-1896-bd20-330125084756 60505-2546 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077642 Apotex Corp. ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 60505-2547_00002548-0fd8-1896-bd20-330125084756 60505-2547 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20051222 ANDA ANDA077642 Apotex Corp. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 60505-2548_6fecc264-9e9f-8c24-9f6b-3ae3cf699d82 60505-2548 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20061010 ANDA ANDA077894 Apotex Corp. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60505-2549_6fecc264-9e9f-8c24-9f6b-3ae3cf699d82 60505-2549 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20061010 ANDA ANDA077894 Apotex Corp. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60505-2550_6fecc264-9e9f-8c24-9f6b-3ae3cf699d82 60505-2550 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20061010 ANDA ANDA077894 Apotex Corp. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60505-2551_6fecc264-9e9f-8c24-9f6b-3ae3cf699d82 60505-2551 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20060915 ANDA ANDA077661 Apotex Corp. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60505-2552_6fecc264-9e9f-8c24-9f6b-3ae3cf699d82 60505-2552 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20060915 ANDA ANDA077661 Apotex Corp. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60505-2575_f3a15eda-7c00-960b-0e0c-ec5fd92c6fac 60505-2575 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20071228 ANDA ANDA077883 Apotex Corp. BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 60505-2578_202a81bc-fc1f-fbca-e086-2d6dba8ae668 60505-2578 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Apotex Corp. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 60505-2579_202a81bc-fc1f-fbca-e086-2d6dba8ae668 60505-2579 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Apotex Corp. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 60505-2580_202a81bc-fc1f-fbca-e086-2d6dba8ae668 60505-2580 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Apotex Corp. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 60505-2581_4215c854-c73e-43a9-3693-feac4671d9be 60505-2581 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110718 ANDA ANDA065507 Apotex Corp. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 60505-2582_4215c854-c73e-43a9-3693-feac4671d9be 60505-2582 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110718 ANDA ANDA065509 Apotex Corp. AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 60505-2584_cf32bbd7-e758-4dcb-c153-ffa781c75893 60505-2584 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20080922 ANDA ANDA077953 Apotex Corp RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2585_cf32bbd7-e758-4dcb-c153-ffa781c75893 60505-2585 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20080922 ANDA ANDA077953 Apotex Corp RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2586_cf32bbd7-e758-4dcb-c153-ffa781c75893 60505-2586 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20080922 ANDA ANDA077953 Apotex Corp RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2587_cf32bbd7-e758-4dcb-c153-ffa781c75893 60505-2587 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20080922 ANDA ANDA077953 Apotex Corp RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2588_cf32bbd7-e758-4dcb-c153-ffa781c75893 60505-2588 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20080922 ANDA ANDA077953 Apotex Corp RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2589_cf32bbd7-e758-4dcb-c153-ffa781c75893 60505-2589 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20080922 ANDA ANDA077953 Apotex Corp RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2597_b961fb84-055a-a3bd-56a6-66a6abdcd885 60505-2597 HUMAN PRESCRIPTION DRUG CABERGOLINE CABERGOLINE TABLET ORAL 20130308 ANDA ANDA201503 Apotex Corp. CABERGOLINE .5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 60505-2606_fc6de515-c61a-d4bc-6a92-ed9b256876cc 60505-2606 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078165 Apotex Corp. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 60505-2607_fc6de515-c61a-d4bc-6a92-ed9b256876cc 60505-2607 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078165 Apotex Corp. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 60505-2608_fc6de515-c61a-d4bc-6a92-ed9b256876cc 60505-2608 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078165 Apotex Corp. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 60505-2609_fc6de515-c61a-d4bc-6a92-ed9b256876cc 60505-2609 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078165 Apotex Corp. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 60505-2615_c07f68b0-0654-f9c8-5e7e-0f738d0d439f 60505-2615 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20070913 ANDA ANDA065384 Apotex Corp CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 60505-2616_c07f68b0-0654-f9c8-5e7e-0f738d0d439f 60505-2616 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20070913 ANDA ANDA065384 Apotex Corp CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 60505-2632_f832c889-561a-e380-e706-12b2d35dc850 60505-2632 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA078317 Apotex Corp. CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 60505-2633_f832c889-561a-e380-e706-12b2d35dc850 60505-2633 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA078317 Apotex Corp. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 60505-2634_9414c54e-519e-4871-71d8-111b241b7b50 60505-2634 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20081112 ANDA ANDA078449 Apotex Corp ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60505-2635_9414c54e-519e-4871-71d8-111b241b7b50 60505-2635 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20081112 ANDA ANDA078449 Apotex Corp ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60505-2636_9414c54e-519e-4871-71d8-111b241b7b50 60505-2636 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20081112 ANDA ANDA078449 Apotex Corp ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60505-2637_9414c54e-519e-4871-71d8-111b241b7b50 60505-2637 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20081112 ANDA ANDA078449 Apotex Corp ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60505-2642_7cd5fd99-ea7f-432d-aa05-8c0ab4fffb75 60505-2642 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET ORAL 20090706 ANDA ANDA078917 Apotex Corp. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] E 20171231 60505-2644_8d38c20d-995f-cd02-e519-6915a04c9a83 60505-2644 HUMAN PRESCRIPTION DRUG Tramadol hydrochloride and acetaminophen Tramadol hydrochloride and acetaminophen TABLET ORAL 20140830 ANDA ANDA078778 Apotex Corp. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 60505-2648_425690e2-bce4-0a9c-938b-f0236659992a 60505-2648 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 ANDA ANDA078868 Apotex Corp. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60505-2649_425690e2-bce4-0a9c-938b-f0236659992a 60505-2649 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 ANDA ANDA078868 Apotex Corp. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60505-2650_425690e2-bce4-0a9c-938b-f0236659992a 60505-2650 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 ANDA ANDA078868 Apotex Corp. TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60505-2651_2b85e78d-ae34-ee00-bd0a-3c681cc95c2e 60505-2651 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20080730 ANDA ANDA078482 Apotex Corp EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 60505-2652_2b85e78d-ae34-ee00-bd0a-3c681cc95c2e 60505-2652 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20080730 ANDA ANDA078482 Apotex Corp EPLERENONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 60505-2653_c273c5d7-b052-3709-0e08-d284e03112db 60505-2653 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071258 Apotex Corp TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 60505-2654_c273c5d7-b052-3709-0e08-d284e03112db 60505-2654 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Apotex Corp TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 60505-2655_c273c5d7-b052-3709-0e08-d284e03112db 60505-2655 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Apotex Corp TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 60505-2656_46c580ad-6bf2-5a85-c006-3d4528dcf947 60505-2656 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20090921 ANDA ANDA071251 Apotex Corp. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 60505-2657_46c580ad-6bf2-5a85-c006-3d4528dcf947 60505-2657 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20090921 ANDA ANDA071251 Apotex Corp. TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 60505-2658_1b50f76c-da1c-8a9b-63f3-d73067814a04 60505-2658 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20081106 ANDA ANDA078578 APOTEX Corp AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 60505-2659_c273c5d7-b052-3709-0e08-d284e03112db 60505-2659 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20090105 ANDA ANDA071196 Apotex Corp TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 60505-2660_af4a01f1-8297-91b5-7f45-01fbe8dea7dc 60505-2660 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20090709 ANDA ANDA079164 Apotex Corp. FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] N 20181231 60505-2661_af4a01f1-8297-91b5-7f45-01fbe8dea7dc 60505-2661 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20090709 ANDA ANDA079164 Apotex Corp. FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 60505-2662_af4a01f1-8297-91b5-7f45-01fbe8dea7dc 60505-2662 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20090709 ANDA ANDA079164 Apotex Corp. FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 60505-2663_4ddc0a25-1514-d7cc-36a0-e6b45ada322f 60505-2663 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078625 Apotex Corp LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 60505-2664_4ddc0a25-1514-d7cc-36a0-e6b45ada322f 60505-2664 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078625 Apotex Corp LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 60505-2665_4ddc0a25-1514-d7cc-36a0-e6b45ada322f 60505-2665 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078625 Apotex Corp LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 60505-2671_202a81bc-fc1f-fbca-e086-2d6dba8ae668 60505-2671 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Apotex Corp. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 60505-2673_7c6c4419-0870-a93a-2e56-2997dde00ee8 60505-2673 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150724 ANDA ANDA078583 Apotex Corp ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2674_7c6c4419-0870-a93a-2e56-2997dde00ee8 60505-2674 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150724 ANDA ANDA078583 Apotex Corp ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2675_7c6c4419-0870-a93a-2e56-2997dde00ee8 60505-2675 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150724 ANDA ANDA078583 Apotex Corp ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2676_7c6c4419-0870-a93a-2e56-2997dde00ee8 60505-2676 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150724 ANDA ANDA078583 Apotex Corp ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2677_7c6c4419-0870-a93a-2e56-2997dde00ee8 60505-2677 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150724 ANDA ANDA078583 Apotex Corp ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-2680_4ddc0a25-1514-d7cc-36a0-e6b45ada322f 60505-2680 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078625 Apotex Corp LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 60505-2780_1054b5b7-7857-ae7f-c380-c1c38917a01c 60505-2780 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Apotex Corp. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-2781_1054b5b7-7857-ae7f-c380-c1c38917a01c 60505-2781 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Apotex Corp. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-2782_1054b5b7-7857-ae7f-c380-c1c38917a01c 60505-2782 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA078777 Apotex Corp. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-2795_732ed781-ebf5-e545-2137-c9902c2da92e 60505-2795 HUMAN PRESCRIPTION DRUG IBANDRONATE SODIUM IBANDRONATE SODIUM TABLET, FILM COATED ORAL 20120319 ANDA ANDA078948 Apotex Corp IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 60505-2805_61721bfa-4385-0ddd-ddc9-15bd8fff88b7 60505-2805 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20120323 ANDA ANDA078986 Apotex Corp. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 60505-2806_61721bfa-4385-0ddd-ddc9-15bd8fff88b7 60505-2806 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20120323 ANDA ANDA078986 Apotex Corp. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 60505-2807_61721bfa-4385-0ddd-ddc9-15bd8fff88b7 60505-2807 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20120323 ANDA ANDA078986 Apotex Corp. CARBAMAZEPINE 300 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 60505-2850_f0b3c869-fb43-5b1c-ca15-81336a11a888 60505-2850 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110718 ANDA ANDA079013 Apotex Corp. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 60505-2865_e104a064-cbfb-2bfb-3cc7-42eb43a077ed 60505-2865 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60505-2866_e104a064-cbfb-2bfb-3cc7-42eb43a077ed 60505-2866 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60505-2867_e104a064-cbfb-2bfb-3cc7-42eb43a077ed 60505-2867 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60505-2868_e104a064-cbfb-2bfb-3cc7-42eb43a077ed 60505-2868 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60505-2869_e104a064-cbfb-2bfb-3cc7-42eb43a077ed 60505-2869 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60505-2870_e104a064-cbfb-2bfb-3cc7-42eb43a077ed 60505-2870 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60505-2871_e104a064-cbfb-2bfb-3cc7-42eb43a077ed 60505-2871 HUMAN PRESCRIPTION DRUG Ropinirole Ropinirole TABLET, FILM COATED ORAL 20130329 ANDA ANDA079165 Apotex Corp. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 60505-2875_30990ce4-7f44-763b-1827-9fd5691f295f 60505-2875 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080620 ANDA ANDA079116 Apotex Corp. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60505-2876_30990ce4-7f44-763b-1827-9fd5691f295f 60505-2876 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080620 ANDA ANDA079116 Apotex Corp. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60505-2877_30990ce4-7f44-763b-1827-9fd5691f295f 60505-2877 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080620 ANDA ANDA079116 Apotex Corp. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60505-2878_30990ce4-7f44-763b-1827-9fd5691f295f 60505-2878 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080620 ANDA ANDA079116 Apotex Corp. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60505-2880_1d30b6f0-1bde-19d4-57a3-9ec809ccd4c5 60505-2880 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20130715 ANDA ANDA200172 Apotex Corp. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 60505-2881_f8372986-43c9-5048-278e-700e2aa6dd91 60505-2881 HUMAN OTC DRUG Ranitidine Ranitidine hydrochloride TABLET, FILM COATED ORAL 20050124 ANDA ANDA075167 Apotex Corp. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 60505-2885_addf360f-116e-b017-eba3-e48be7bcbc38 60505-2885 HUMAN PRESCRIPTION DRUG ROSUVASTATIN ROSUVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170829 ANDA ANDA079145 Apotex Corp. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60505-2886_addf360f-116e-b017-eba3-e48be7bcbc38 60505-2886 HUMAN PRESCRIPTION DRUG ROSUVASTATIN ROSUVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170829 ANDA ANDA079145 Apotex Corp. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60505-2887_addf360f-116e-b017-eba3-e48be7bcbc38 60505-2887 HUMAN PRESCRIPTION DRUG ROSUVASTATIN ROSUVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170829 ANDA ANDA079145 Apotex Corp. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60505-2888_addf360f-116e-b017-eba3-e48be7bcbc38 60505-2888 HUMAN PRESCRIPTION DRUG ROSUVASTATIN ROSUVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170829 ANDA ANDA079145 Apotex Corp. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60505-2900_e24b1f73-ca4a-cf3c-b0b7-6121bb090667 60505-2900 HUMAN PRESCRIPTION DRUG Imatinib Mesylate Imatinib Mesylate TABLET, FILM COATED ORAL 20160805 ANDA ANDA079179 Apotex Corp IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 60505-2901_e24b1f73-ca4a-cf3c-b0b7-6121bb090667 60505-2901 HUMAN PRESCRIPTION DRUG Imatinib Mesylate Imatinib Mesylate TABLET, FILM COATED ORAL 20160805 ANDA ANDA079179 Apotex Corp IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 60505-2938_fc6de515-c61a-d4bc-6a92-ed9b256876cc 60505-2938 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078165 Apotex Corp. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 60505-2945_0dad1c46-18cc-9d4e-2cee-53cf592e1047 60505-2945 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20170612 ANDA ANDA208332 Apotex Corp. EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 60505-2965_d0b0d1dd-17f3-c02d-bd99-f434e6edd763 60505-2965 HUMAN PRESCRIPTION DRUG Mycophenolic Acid Mycophenolic Acid TABLET, DELAYED RELEASE ORAL 20120821 ANDA ANDA091558 Apotex Corp MYCOPHENOLATE SODIUM 180 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 60505-2966_d0b0d1dd-17f3-c02d-bd99-f434e6edd763 60505-2966 HUMAN PRESCRIPTION DRUG Mycophenolic Acid Mycophenolic Acid TABLET, DELAYED RELEASE ORAL 20140819 ANDA ANDA091558 Apotex Corp MYCOPHENOLATE SODIUM 360 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 60505-2985_c46e6d23-35ba-f88a-1d25-a6ac15a18fca 60505-2985 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20120531 ANDA ANDA200654 Apotex Corp. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 60505-2995_8e27db56-8fba-55f6-5bf6-09dab9a2b377 60505-2995 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Apotex Corp. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 60505-2996_8e27db56-8fba-55f6-5bf6-09dab9a2b377 60505-2996 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Apotex Corp. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 60505-2997_8e27db56-8fba-55f6-5bf6-09dab9a2b377 60505-2997 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Apotex Corp. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 60505-3075_7c6c4419-0870-a93a-2e56-2997dde00ee8 60505-3075 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150724 ANDA ANDA078583 Apotex Corp ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3096_1da1085d-93a4-d093-60fc-500db3d70cea 60505-3096 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20140611 ANDA ANDA090877 Apotex Corp. RISEDRONATE SODIUM 75 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 60505-3097_1da1085d-93a4-d093-60fc-500db3d70cea 60505-3097 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20140611 ANDA ANDA090877 Apotex Corp. RISEDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 60505-3110_7d1ebc67-695f-0176-0ad1-02b3d684d974 60505-3110 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3111_7d1ebc67-695f-0176-0ad1-02b3d684d974 60505-3111 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3112_7d1ebc67-695f-0176-0ad1-02b3d684d974 60505-3112 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3113_7d1ebc67-695f-0176-0ad1-02b3d684d974 60505-3113 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3114_7d1ebc67-695f-0176-0ad1-02b3d684d974 60505-3114 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3115_b332e90b-8d4a-cd74-7647-d444617da680 60505-3115 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20131230 ANDA ANDA091431 Apotex Corp. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60505-3116_b332e90b-8d4a-cd74-7647-d444617da680 60505-3116 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20131230 ANDA ANDA091431 Apotex Corp. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60505-3117_b332e90b-8d4a-cd74-7647-d444617da680 60505-3117 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20131230 ANDA ANDA091431 Apotex Corp. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60505-3118_b332e90b-8d4a-cd74-7647-d444617da680 60505-3118 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20131230 ANDA ANDA091431 Apotex Corp. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60505-3120_2f919051-4227-d707-5491-8088da0b2b65 60505-3120 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20130726 ANDA ANDA202252 Apotex Corp. FENOFIBRATE 43 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20191231 60505-3121_2f919051-4227-d707-5491-8088da0b2b65 60505-3121 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20130726 ANDA ANDA202252 Apotex Corp. FENOFIBRATE 130 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20191231 60505-3130_49c77a3c-c5d6-45f9-45d0-eccf0644d989 60505-3130 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3131_49c77a3c-c5d6-45f9-45d0-eccf0644d989 60505-3131 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3132_49c77a3c-c5d6-45f9-45d0-eccf0644d989 60505-3132 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3133_49c77a3c-c5d6-45f9-45d0-eccf0644d989 60505-3133 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3134_49c77a3c-c5d6-45f9-45d0-eccf0644d989 60505-3134 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3135_49c77a3c-c5d6-45f9-45d0-eccf0644d989 60505-3135 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3136_49c77a3c-c5d6-45f9-45d0-eccf0644d989 60505-3136 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3137_49c77a3c-c5d6-45f9-45d0-eccf0644d989 60505-3137 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3138_49c77a3c-c5d6-45f9-45d0-eccf0644d989 60505-3138 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3139_49c77a3c-c5d6-45f9-45d0-eccf0644d989 60505-3139 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA090960 Apotex Corp. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3140_7d1ebc67-695f-0176-0ad1-02b3d684d974 60505-3140 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Apotex Corp. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3145_1d0c0c59-07c0-bc3d-726d-d1513c6a3391 60505-3145 HUMAN PRESCRIPTION DRUG Cevimeline Hydrochloride cevimeline hydrochloride CAPSULE ORAL 20121008 ANDA ANDA091260 Apotex Corp. CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 60505-3165_1da1085d-93a4-d093-60fc-500db3d70cea 60505-3165 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20151130 ANDA ANDA090877 Apotex Corp. RISEDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 60505-3170_5c58f9fd-4bdf-78ad-c265-341d31aa8087 60505-3170 HUMAN PRESCRIPTION DRUG Omega-3-acid ethyl esters Omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20140930 ANDA ANDA090973 Apotex Corp. OMEGA-3-ACID ETHYL ESTERS 1 g/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 60505-3220_4ccb7652-fade-f764-bb08-b187af0a5a88 60505-3220 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130220 ANDA ANDA091072 Apotex Corp. RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60505-3221_4ccb7652-fade-f764-bb08-b187af0a5a88 60505-3221 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130220 ANDA ANDA091072 Apotex Corp. RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60505-3222_4ccb7652-fade-f764-bb08-b187af0a5a88 60505-3222 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130220 ANDA ANDA091072 Apotex Corp. RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60505-3223_4ccb7652-fade-f764-bb08-b187af0a5a88 60505-3223 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130220 ANDA ANDA091072 Apotex Corp. RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60505-3225_b332e90b-8d4a-cd74-7647-d444617da680 60505-3225 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20131230 ANDA ANDA091431 Apotex Corp. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60505-3226_b332e90b-8d4a-cd74-7647-d444617da680 60505-3226 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20131230 ANDA ANDA091431 Apotex Corp. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60505-3245_99e6b381-7586-e4ee-34f7-8b6b88c13854 60505-3245 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20111220 ANDA ANDA091480 Apotex Corp. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60505-3246_99e6b381-7586-e4ee-34f7-8b6b88c13854 60505-3246 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20111220 ANDA ANDA091480 Apotex Corp. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60505-3247_99e6b381-7586-e4ee-34f7-8b6b88c13854 60505-3247 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20111220 ANDA ANDA091480 Apotex Corp. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60505-3250_b3c20514-775f-4a6f-464c-d6a89d08a5c4 60505-3250 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20140103 ANDA ANDA202941 Apotex Corp. LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 60505-3251_663a667c-0060-338a-4611-8fb06cf805e7 60505-3251 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20111202 ANDA ANDA091606 Apotex Corp. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 60505-3252_663a667c-0060-338a-4611-8fb06cf805e7 60505-3252 HUMAN PRESCRIPTION DRUG LAMIVUDINE lamivudine TABLET, FILM COATED ORAL 20111202 ANDA ANDA091606 Apotex Corp. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 60505-3255_22090a89-2a78-780f-1a43-1a407ac21840 60505-3255 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20120531 ANDA ANDA091303 Apotex Corp. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 60505-3275_3fc342b4-ccf1-00eb-51cd-130d5c8cae45 60505-3275 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA091265 Apotex Corp. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3276_3fc342b4-ccf1-00eb-51cd-130d5c8cae45 60505-3276 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA091265 Apotex Corp. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3277_3fc342b4-ccf1-00eb-51cd-130d5c8cae45 60505-3277 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA091265 Apotex Corp. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3278_3fc342b4-ccf1-00eb-51cd-130d5c8cae45 60505-3278 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA091265 Apotex Corp. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 60505-3280_80ebd81e-227d-cafb-368d-48f258078482 60505-3280 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091261 Apotex Corp. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 60505-3285_88f20c6d-c304-0d45-19ce-676cd6e52d9e 60505-3285 HUMAN PRESCRIPTION DRUG RILUZOLE RILUZOLE TABLET, FILM COATED ORAL 20130618 ANDA ANDA091300 Apotex Corp RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] N 20181231 60505-3404_f57a9717-69c5-56ac-9bfb-7540bf73bac4 60505-3404 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20121106 ANDA ANDA091379 Apotex Corp. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 60505-3409_32d6a005-b594-6802-0466-ec997d4b85f5 60505-3409 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130312 ANDA ANDA091524 Apotex Corp QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-3410_32d6a005-b594-6802-0466-ec997d4b85f5 60505-3410 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130312 ANDA ANDA091524 Apotex Corp QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-3411_32d6a005-b594-6802-0466-ec997d4b85f5 60505-3411 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130312 ANDA ANDA091524 Apotex Corp QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-3438_c177d604-0b12-12d0-2dbf-9602b6fab238 60505-3438 HUMAN PRESCRIPTION DRUG Selegiline Hydrochloride Selegiline Hydrochloride TABLET ORAL 19970706 ANDA ANDA074871 Apotex Corp. SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 60505-3454_5c843d83-0799-3bb8-662e-01f186b1d230 60505-3454 HUMAN PRESCRIPTION DRUG TROSPIUM CHLORIDE TROSPIUM CHLORIDE TABLET ORAL 20121015 ANDA ANDA091513 Apotex Corp. TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 60505-3517_80ebd81e-227d-cafb-368d-48f258078482 60505-3517 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091261 Apotex Corp. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 60505-3518_80ebd81e-227d-cafb-368d-48f258078482 60505-3518 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150225 ANDA ANDA202958 Apotex Corp. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 60505-3532_55c3a99a-a1d2-57a8-40fd-bd533833a697 60505-3532 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel bisulfate TABLET, FILM COATED ORAL 20140304 ANDA ANDA076274 Apotex Corp. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 60505-3562_bfc7f26e-6ec2-a415-d06a-21d152d2da42 60505-3562 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA201294 Apotex Corp MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 60505-3573_bfc7f26e-6ec2-a415-d06a-21d152d2da42 60505-3573 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA201508 Apotex Corp MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 60505-3574_bfc7f26e-6ec2-a415-d06a-21d152d2da42 60505-3574 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA201508 Apotex Corp MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 60505-3578_c3895624-6196-1b2c-1230-fbf8f03226d6 60505-3578 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100514 ANDA ANDA077928 Apotex Corp MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60505-3579_c3895624-6196-1b2c-1230-fbf8f03226d6 60505-3579 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100514 ANDA ANDA077928 Apotex Corp MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 60505-3583_b59f8ce4-ff1e-1505-ff74-e961ede0e7a4 60505-3583 HUMAN PRESCRIPTION DRUG Abacavir Sulfate Abacavir Sulfate TABLET, FILM COATED ORAL 20121217 ANDA ANDA201570 Apotex Corp ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 60505-3618_104899fe-c7ef-2935-ef24-8b519309c483 60505-3618 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil Candesartan cilexetil TABLET ORAL 20140113 ANDA ANDA202079 Apotex Corp. CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60505-3619_104899fe-c7ef-2935-ef24-8b519309c483 60505-3619 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil Candesartan Cilexetil TABLET ORAL 20140113 ANDA ANDA202079 Apotex Corp. CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60505-3620_104899fe-c7ef-2935-ef24-8b519309c483 60505-3620 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil Candesartan Cilexetil TABLET ORAL 20140113 ANDA ANDA202079 Apotex Corp. CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60505-3621_104899fe-c7ef-2935-ef24-8b519309c483 60505-3621 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil Candesartan Cilexetil TABLET ORAL 20140113 ANDA ANDA202079 Apotex Corp. CANDESARTAN CILEXETIL 32 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60505-3638_338105b9-f381-2856-c9f4-72439c5f9be4 60505-3638 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid TABLET ORAL 20140127 ANDA ANDA202286 Apotex Corp. TRANEXAMIC ACID 650 1/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 60505-3663_cae3423b-8bc3-ea9a-4ce9-f73ca4fa2c6d 60505-3663 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride TABLET, FILM COATED ORAL 20110101 NDA NDA020031 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-3664_cae3423b-8bc3-ea9a-4ce9-f73ca4fa2c6d 60505-3664 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride TABLET, FILM COATED ORAL 20110101 NDA NDA020031 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-3665_cae3423b-8bc3-ea9a-4ce9-f73ca4fa2c6d 60505-3665 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride TABLET, FILM COATED ORAL 20110101 NDA NDA020031 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-3666_cae3423b-8bc3-ea9a-4ce9-f73ca4fa2c6d 60505-3666 HUMAN PRESCRIPTION DRUG PAXIL paroxetine hydrochloride TABLET, FILM COATED ORAL 20110101 NDA NDA020031 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-3668_d708f802-1207-2f39-40d2-5a58282954ab 60505-3668 HUMAN PRESCRIPTION DRUG PAXIL CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110101 NDA NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-3669_d708f802-1207-2f39-40d2-5a58282954ab 60505-3669 HUMAN PRESCRIPTION DRUG PAXIL CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110101 NDA NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-3670_d708f802-1207-2f39-40d2-5a58282954ab 60505-3670 HUMAN PRESCRIPTION DRUG PAXIL CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110101 NDA NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-3673_e51e28f1-4417-19f4-57f0-98bfbf08437c 60505-3673 HUMAN PRESCRIPTION DRUG PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100913 NDA NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-3674_e51e28f1-4417-19f4-57f0-98bfbf08437c 60505-3674 HUMAN PRESCRIPTION DRUG PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100913 NDA NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-3675_e51e28f1-4417-19f4-57f0-98bfbf08437c 60505-3675 HUMAN PRESCRIPTION DRUG PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100913 NDA NDA020936 Apotex Corp PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60505-3678_de30f26f-356a-4c74-bea2-ba475804c70f 60505-3678 HUMAN PRESCRIPTION DRUG Carvedilol Phosphate carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20171109 NDA AUTHORIZED GENERIC NDA022012 Apotex Corp. CARVEDILOL PHOSPHATE 10 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 60505-3679_de30f26f-356a-4c74-bea2-ba475804c70f 60505-3679 HUMAN PRESCRIPTION DRUG Carvedilol Phosphate carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20171109 NDA AUTHORIZED GENERIC NDA022012 Apotex Corp. CARVEDILOL PHOSPHATE 20 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 60505-3680_de30f26f-356a-4c74-bea2-ba475804c70f 60505-3680 HUMAN PRESCRIPTION DRUG Carvedilol Phosphate carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20171109 NDA AUTHORIZED GENERIC NDA022012 Apotex Corp. CARVEDILOL PHOSPHATE 40 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 60505-3681_de30f26f-356a-4c74-bea2-ba475804c70f 60505-3681 HUMAN PRESCRIPTION DRUG Carvedilol Phosphate carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20171109 NDA AUTHORIZED GENERIC NDA022012 Apotex Corp. CARVEDILOL PHOSPHATE 80 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 60505-3693_575c4626-a2e4-7ac0-4e6f-023486751554 60505-3693 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20130514 ANDA ANDA202078 Apotex Corp ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 60505-3694_575c4626-a2e4-7ac0-4e6f-023486751554 60505-3694 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20130514 ANDA ANDA202078 Apotex Corp ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 60505-3713_ec62d095-ab45-2e8f-a61a-95e4018c6340 60505-3713 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20150213 ANDA ANDA203027 Apotex Corp. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 60505-3718_575c4626-a2e4-7ac0-4e6f-023486751554 60505-3718 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130514 ANDA ANDA202476 Apotex Corp ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 60505-3719_575c4626-a2e4-7ac0-4e6f-023486751554 60505-3719 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130514 ANDA ANDA202476 Apotex Corp ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 60505-3723_9b2b8edf-3f34-f722-b390-f056feba8679 60505-3723 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA202477 Apotex Corp RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 60505-3724_9b2b8edf-3f34-f722-b390-f056feba8679 60505-3724 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA202477 Apotex Corp RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 60505-3758_d9488956-5971-8629-a993-b38990ac8e16 60505-3758 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide TABLET ORAL 20121204 ANDA ANDA202884 Apotex Corp. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 16; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-3759_d9488956-5971-8629-a993-b38990ac8e16 60505-3759 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide TABLET ORAL 20121204 ANDA ANDA202884 Apotex Corp. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-3760_d9488956-5971-8629-a993-b38990ac8e16 60505-3760 HUMAN PRESCRIPTION DRUG Candesartan Cilexetil and Hydrochlorothiazide Candesartan Cilexetil and Hydrochlorothiazide TABLET ORAL 20130603 ANDA ANDA202884 Apotex Corp. CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-3806_1019a98c-9a19-2c65-1822-6e0118a0c8eb 60505-3806 HUMAN PRESCRIPTION DRUG valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA203026 Apotex Corp. VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-3807_1019a98c-9a19-2c65-1822-6e0118a0c8eb 60505-3807 HUMAN PRESCRIPTION DRUG valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA203026 Apotex Corp. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-3808_1019a98c-9a19-2c65-1822-6e0118a0c8eb 60505-3808 HUMAN PRESCRIPTION DRUG valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA203026 Apotex Corp. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-3809_1019a98c-9a19-2c65-1822-6e0118a0c8eb 60505-3809 HUMAN PRESCRIPTION DRUG valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA203026 Apotex Corp. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-3810_1019a98c-9a19-2c65-1822-6e0118a0c8eb 60505-3810 HUMAN PRESCRIPTION DRUG valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA203026 Apotex Corp. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60505-3847_0b0977ef-6fad-dce1-4ec3-3eb531cc4563 60505-3847 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 Apotex Corp. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60505-3848_0b0977ef-6fad-dce1-4ec3-3eb531cc4563 60505-3848 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 Apotex Corp. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60505-3849_0b0977ef-6fad-dce1-4ec3-3eb531cc4563 60505-3849 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 Apotex Corp. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60505-3877_6c93c56a-bd51-49bb-f069-8a1379d7bfc3 60505-3877 HUMAN PRESCRIPTION DRUG Dutasteride dutasteride CAPSULE, LIQUID FILLED ORAL 20151125 ANDA ANDA204292 Apotex Corp. DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 60505-3952_1fcb39a7-e54c-096d-9d28-f86bd0eca8bb 60505-3952 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Apotex Corp OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60505-3992_55c3a99a-a1d2-57a8-40fd-bd533833a697 60505-3992 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076274 Apotex Corp. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 60505-4058_4e927287-7e4f-5944-ab25-94159877ce6a 60505-4058 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET, EXTENDED RELEASE ORAL 20140415 ANDA ANDA205258 Apotex Corp NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 60505-4089_c273c5d7-b052-3709-0e08-d284e03112db 60505-4089 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20141231 ANDA ANDA071196 Apotex Corp TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 60505-4322_d5861f6c-c137-011b-0632-60f31123e753 60505-4322 HUMAN OTC DRUG Cetirizine Cetirizine CAPSULE, LIQUID FILLED ORAL 20170707 ANDA ANDA207235 Apotex Corp. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 60505-4362_2ac85a1a-688d-4cd5-a76e-9b950a354485 60505-4362 HUMAN PRESCRIPTION DRUG LINEZOLID Linezolid TABLET, FILM COATED ORAL 20150622 NDA AUTHORIZED GENERIC NDA021130 Apotex Corp. LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 60505-4502_f02e4711-d4a0-eb9d-255d-075a3ad770e9 60505-4502 HUMAN PRESCRIPTION DRUG ROSUVASTATIN ROSUVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160720 ANDA ANDA079145 Apotex Corp. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60505-4503_f02e4711-d4a0-eb9d-255d-075a3ad770e9 60505-4503 HUMAN PRESCRIPTION DRUG ROSUVASTATIN ROSUVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160720 ANDA ANDA079145 Apotex Corp. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60505-4504_f02e4711-d4a0-eb9d-255d-075a3ad770e9 60505-4504 HUMAN PRESCRIPTION DRUG ROSUVASTATIN ROSUVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160720 ANDA ANDA079145 Apotex Corp. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60505-4505_f02e4711-d4a0-eb9d-255d-075a3ad770e9 60505-4505 HUMAN PRESCRIPTION DRUG ROSUVASTATIN ROSUVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160720 ANDA ANDA079145 Apotex Corp. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60505-4557_c3b86bc2-b53b-fb0a-f04c-8e8fb0e79501 60505-4557 HUMAN OTC DRUG Daytime Cold and Flu Relief Non Drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160909 OTC MONOGRAPH FINAL part341 Apotex Corp. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 60505-4558_6f474f2f-7bc4-49e2-c1e2-b6f87aefa6a2 60505-4558 HUMAN OTC DRUG Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20160909 OTC MONOGRAPH FINAL part341 Apotex Corp ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 60505-4582_575d2388-51c2-1057-b412-43d387051b92 60505-4582 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170815 ANDA ANDA207807 Apotex Corp. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60505-4583_575d2388-51c2-1057-b412-43d387051b92 60505-4583 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170815 ANDA ANDA207807 Apotex Corp. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60505-4584_575d2388-51c2-1057-b412-43d387051b92 60505-4584 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170815 ANDA ANDA207807 Apotex Corp. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60505-4585_575d2388-51c2-1057-b412-43d387051b92 60505-4585 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170815 ANDA ANDA207807 Apotex Corp. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60505-4623_d252dcad-7e91-af7d-e78c-41853538665c 60505-4623 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20170727 ANDA ANDA200172 Apotex Corp. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 60505-4642_753f0b91-f7c2-b7f8-fdd7-c4bfb0b7e515 60505-4642 HUMAN PRESCRIPTION DRUG Prasugrel Prasugrel TABLET, FILM COATED ORAL 20171016 ANDA ANDA205897 Apotex Corp. PRASUGREL HYDROCHLORIDE 5 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 60505-4643_753f0b91-f7c2-b7f8-fdd7-c4bfb0b7e515 60505-4643 HUMAN PRESCRIPTION DRUG Prasugrel Prasugrel TABLET, FILM COATED ORAL 20171016 ANDA ANDA205897 Apotex Corp. PRASUGREL HYDROCHLORIDE 10 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 60505-4649_2ada5057-84c1-a190-0bca-bbacc40b12ce 60505-4649 HUMAN OTC DRUG LORATADINE Loratadine TABLET ORAL 20171121 ANDA ANDA076471 Apotex Corp. LORATADINE 10 mg/1 N 20181231 60505-4650_ae75f655-e2f7-5e30-7a01-de2c996a7ca7 60505-4650 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20180206 ANDA ANDA078317 Apotex Corp. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20191231 60505-4652_82674d7b-8472-c313-ccc5-4b0fb2bc0908 60505-4652 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20171204 ANDA ANDA203281 Apotex Corp. OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60505-4653_82674d7b-8472-c313-ccc5-4b0fb2bc0908 60505-4653 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20171204 ANDA ANDA203281 Apotex Corp. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60505-4654_82674d7b-8472-c313-ccc5-4b0fb2bc0908 60505-4654 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20171204 ANDA ANDA203281 Apotex Corp. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60505-4666_9d29d866-2ba3-4e25-aca2-b085a2bdb9a1 60505-4666 HUMAN PRESCRIPTION DRUG Tenofovir Disoproxil Fumarate Tenofovir Disoproxil Fumarate TABLET, COATED ORAL 20180126 ANDA ANDA209498 Apotex Corp. TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 60505-5306_816102bd-8841-7b28-989f-5f8a6f2bc2ed 60505-5306 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20070609 ANDA ANDA077309 Apotex Corp. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60505-5307_816102bd-8841-7b28-989f-5f8a6f2bc2ed 60505-5307 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20060313 ANDA ANDA077309 Apotex Corp. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60505-6025_4ba81ea1-90b5-423e-a2b0-fcaad296663a 60505-6025 HUMAN PRESCRIPTION DRUG Cefoxitin CEFOXITIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080227 ANDA ANDA065313 Apotex Corporation CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6026_4ba81ea1-90b5-423e-a2b0-fcaad296663a 60505-6026 HUMAN PRESCRIPTION DRUG Cefoxitin CEFOXITIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20080227 ANDA ANDA065313 Apotex Corporation CEFOXITIN SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6030_78144754-41eb-4d03-a620-41b0a7ac679a 60505-6030 HUMAN PRESCRIPTION DRUG Cefepime CEFEPIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070618 ANDA ANDA065369 Apotex Corporation CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6031_78144754-41eb-4d03-a620-41b0a7ac679a 60505-6031 HUMAN PRESCRIPTION DRUG Cefepime CEFEPIME INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20070618 ANDA ANDA065369 Apotex Corporation CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6076_04f83cbb-e4c0-e1fa-ccdc-90d6917f97e3 60505-6076 HUMAN PRESCRIPTION DRUG Azithromycin azithromycin for injection injection, powder, lyophilized, for solution INJECTION INTRAVENOUS 20100425 ANDA ANDA065501 APOTEX CORP. AZITHROMYCIN MONOHYDRATE 500 mg/10mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 60505-6093_8dbf8bc9-20cc-495d-ace2-b8d8321ca74c 60505-6093 HUMAN PRESCRIPTION DRUG Cefazolin CEFAZOLIN INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051007 ANDA ANDA065226 Apotex Corporation CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6094_d6ab26ec-23bf-43d3-8c03-0a08fdf26a45 60505-6094 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120420 ANDA ANDA065247 Apotex Corporation CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6097_b43342a6-c030-d812-8c28-ce3d70cc7e31 60505-6097 HUMAN PRESCRIPTION DRUG Ibandronate Sodium ibandronate sodium INJECTION INTRAVENOUS 20160113 ANDA ANDA204222 Apotex Corp. IBANDRONATE SODIUM 3 mg/3mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 60505-6101_fa768c7b-5d35-d496-72d0-7efefe3d736e 60505-6101 HUMAN PRESCRIPTION DRUG Bivalirudin bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170717 ANDA ANDA204876 Apotex corp BIVALIRUDIN 250 mg/1 Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 60505-6102_ada68bcc-7395-4747-baf0-cf54a884deee 60505-6102 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6104_ada68bcc-7395-4747-baf0-cf54a884deee 60505-6104 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050802 ANDA ANDA065230 Apotex Corporation CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6110_9950935d-8c2c-4023-ae74-102d41444d12 60505-6110 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170324 ANDA ANDA202930 Apotex Corp ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 60505-6128_d97a3618-b181-452c-872b-ca529bc44700 60505-6128 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20171130 ANDA ANDA203380 Apotex Corp. IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 60505-6129_b4e581b6-3160-e7ad-48a9-6ea507ce71c1 60505-6129 HUMAN OTC DRUG Budesonide Budesonide SPRAY, METERED NASAL 20160419 ANDA ANDA078949 Apotex Corp. BUDESONIDE 32 ug/1 N 20181231 60505-6130_2da177f2-e8c8-b147-a2f8-275644c50ee1 60505-6130 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON INJECTION INTRAMUSCULAR; INTRAVENOUS 20160526 ANDA ANDA203711 Apotex Corp. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 60505-6132_788ffa40-d415-4eb7-8d84-dd1b4a3dedf9 60505-6132 HUMAN PRESCRIPTION DRUG oxaliplatin oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20170104 ANDA ANDA204368 Apotex Corp. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 60505-6134_fe8cb3ea-c71e-8dd4-15e5-a44a03877cf7 60505-6134 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160531 ANDA ANDA208150 Apotex Corp. FLUTICASONE PROPIONATE 50 ug/1 N 20181231 60505-6142_5b02236b-4e4b-4ed4-ace5-8efa39b17d91 60505-6142 HUMAN PRESCRIPTION DRUG Cefazolin CEFAZOLIN INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170630 ANDA ANDA203661 Apotex Corp. CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6144_509d9fdd-323e-43e4-af1a-bcdbfca64693 60505-6144 HUMAN PRESCRIPTION DRUG Cefepime Cefepime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171114 ANDA ANDA203704 Apotex Corp. CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6145_509d9fdd-323e-43e4-af1a-bcdbfca64693 60505-6145 HUMAN PRESCRIPTION DRUG Cefepime Cefepime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20171114 ANDA ANDA203704 Apotex Corp. CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6146_bf828512-d6aa-48d9-a306-d42817fc931c 60505-6146 HUMAN PRESCRIPTION DRUG Cefepime Cefepime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170330 ANDA ANDA203704 Apotex Corp. CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6147_bf828512-d6aa-48d9-a306-d42817fc931c 60505-6147 HUMAN PRESCRIPTION DRUG Cefepime Cefepime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170330 ANDA ANDA203704 Apotex Corp. CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6148_1d8de936-ff43-4563-8d7b-7fd22f998759 60505-6148 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170630 ANDA ANDA203702 Apotex Corp. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6149_1d8de936-ff43-4563-8d7b-7fd22f998759 60505-6149 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170630 ANDA ANDA203702 Apotex Corp. CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6151_1d8de936-ff43-4563-8d7b-7fd22f998759 60505-6151 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170630 ANDA ANDA203702 Apotex Corp. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6152_1d8de936-ff43-4563-8d7b-7fd22f998759 60505-6152 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170630 ANDA ANDA203702 Apotex Corp. CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60505-6160_5df948af-ddf5-71e8-e053-2a91aa0a0236 60505-6160 HUMAN PRESCRIPTION DRUG DORIPENEM DORIPENEM POWDER, FOR SOLUTION INTRAVENOUS 20161205 NDA NDA022106 Apotex Corp. DORIPENEM 250 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 60505-6161_5df948af-ddf5-71e8-e053-2a91aa0a0236 60505-6161 HUMAN PRESCRIPTION DRUG DORIPENEM DORIPENEM POWDER, FOR SOLUTION INTRAVENOUS 20161205 NDA NDA022106 Apotex Corp. DORIPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 60505-6166_8853d1a9-fdba-845c-469d-484c7f0447ca 60505-6166 HUMAN PRESCRIPTION DRUG Clofarabine clofarabine INJECTION INTRAVENOUS 20180101 ANDA ANDA209775 Apotex Corp. CLOFARABINE 1 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 60505-6167_74332bc0-72c4-343e-8091-9f80b00b1985 60505-6167 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20170301 ANDA ANDA208150 Apotex Corp. FLUTICASONE PROPIONATE 50 ug/1 N 20181231 60505-7001_2799dc9e-fbb6-d205-ae23-5ad3f91193f7 60505-7001 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Apotex Corp. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7002_2799dc9e-fbb6-d205-ae23-5ad3f91193f7 60505-7002 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Apotex Corp. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7003_2799dc9e-fbb6-d205-ae23-5ad3f91193f7 60505-7003 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Apotex Corp. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7004_2799dc9e-fbb6-d205-ae23-5ad3f91193f7 60505-7004 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Apotex Corp. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7006_e7df6bc0-959b-4010-614b-c4a77de3b53f 60505-7006 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Apotex Corp. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7007_e7df6bc0-959b-4010-614b-c4a77de3b53f 60505-7007 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Apotex Corp. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7008_e7df6bc0-959b-4010-614b-c4a77de3b53f 60505-7008 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Apotex Corp. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7009_e7df6bc0-959b-4010-614b-c4a77de3b53f 60505-7009 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Apotex Corp. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7010_e7df6bc0-959b-4010-614b-c4a77de3b53f 60505-7010 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20160122 ANDA ANDA077449 Apotex Corp. FENTANYL 12 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7011_e7df6bc0-959b-4010-614b-c4a77de3b53f 60505-7011 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Apotex Corp. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7012_e7df6bc0-959b-4010-614b-c4a77de3b53f 60505-7012 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Apotex Corp. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7013_e7df6bc0-959b-4010-614b-c4a77de3b53f 60505-7013 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Apotex Corp. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7014_e7df6bc0-959b-4010-614b-c4a77de3b53f 60505-7014 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Apotex Corp. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60505-7064_0c25f397-8ff9-0a55-66ae-5023a8a3a838 60505-7064 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 19971020 ANDA ANDA074612 Apotex Corp NICOTINE 7 mg/24h N 20191231 60505-7065_0c25f397-8ff9-0a55-66ae-5023a8a3a838 60505-7065 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 19971020 ANDA ANDA074612 Apotex Corp NICOTINE 14 mg/24h N 20191231 60505-7066_0c25f397-8ff9-0a55-66ae-5023a8a3a838 60505-7066 HUMAN OTC DRUG Nicotine Transdermal System Nicotine Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 19971020 ANDA ANDA074612 Apotex Corp NICOTINE 21 mg/24h N 20191231 60505-7080_c9ffe800-9c8b-72ef-cf0f-8aa3ccd4faaa 60505-7080 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20180110 ANDA ANDA077449 Apotex Corp. FENTANYL 12 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 60505-7081_c9ffe800-9c8b-72ef-cf0f-8aa3ccd4faaa 60505-7081 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20180110 ANDA ANDA077449 Apotex Corp. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 60505-7082_c9ffe800-9c8b-72ef-cf0f-8aa3ccd4faaa 60505-7082 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20180110 ANDA ANDA077449 Apotex Corp. FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 60505-7083_c9ffe800-9c8b-72ef-cf0f-8aa3ccd4faaa 60505-7083 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20180110 ANDA ANDA077449 Apotex Corp. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 60505-7084_c9ffe800-9c8b-72ef-cf0f-8aa3ccd4faaa 60505-7084 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20180110 ANDA ANDA077449 Apotex Corp. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 60505-7085_c9ffe800-9c8b-72ef-cf0f-8aa3ccd4faaa 60505-7085 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20180110 ANDA ANDA077449 Apotex Corp. FENTANYL 37.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 60505-7086_c9ffe800-9c8b-72ef-cf0f-8aa3ccd4faaa 60505-7086 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20180110 ANDA ANDA077449 Apotex Corp. FENTANYL 62.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 60505-7087_c9ffe800-9c8b-72ef-cf0f-8aa3ccd4faaa 60505-7087 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20180110 ANDA ANDA077449 Apotex Corp. FENTANYL 87.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 60512-0001_507d1e18-5d55-463f-ae7d-1ab5b4c5f00b 60512-0001 HUMAN OTC DRUG PMS RELIEF CIMICIFUGA RACEMOSA, MERCURIUS CORROSIVUS, SABINA, HYDRASTIS CANADENSIS, SECALE CORNUTUM, AURUM METALLICUM, HYOSCYAMUS NIGER, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACTAEA CIMICIFUGA ROOT; MERCURIC CHLORIDE; JUNIPERUS SABINA LEAFY TWIG; HYDRASTIS CANADENSIS WHOLE; CLAVICEPS PURPUREA SCLEROTIUM; GOLD; HYOSCYAMUS NIGER WHOLE; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID 4; 9; 8; 4; 3; 9; 3; 4; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0002_29759bb3-63e9-4554-8d7f-253c753be95d 60512-0002 HUMAN OTC DRUG ECZEMA RELIEF NATRUM MURIATICUM, AGARICUS MUSCARIUS, PETROLEUM, SEPIA, KALI ARSENICOSUM, ALUMINA PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SODIUM CHLORIDE; AMANITA MUSCARIA WHOLE; KEROSENE; SEPIA OFFICINALIS JUICE; POTASSIUM ARSENITE ANHYDROUS; ALUMINUM OXIDE 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 60512-0004_d41a82b6-34a5-4bd3-a343-299c37eee30a 60512-0004 HUMAN OTC DRUG ALLERGY RELIEF ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, SABADILLA, STICTA PULMONARIA, CUPRUM METALLICUM, ARALIA RACEMOSA PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALLIUM CEPA WHOLE; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; COPPER; ARALIA RACEMOSA ROOT 6; 9; 6; 6; 6; 9; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0006_94d6ed7f-9a04-4f33-ab42-9735780aa2c4 60512-0006 HUMAN OTC DRUG NATURCOKSINUM FLU RELIEF ANAS BARBARIAE HEPATIS ET CORDIS EXTRACTUM PELLET ORAL 19940814 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/g N 20181231 60512-0007_0653326e-43f6-4a4f-889a-218e05afe37d 60512-0007 HUMAN OTC DRUG ACNE RELIEF SAPONARIA, ECHINACEA ANGUSTIFOLIA, KALIUM BROMATUM, VIOLA TRICOLOR, SELENIUM METALLICUM, NUX VOMICA, THUJA OCCIDENTALIS, PULSATILLA, CALCAREA PICRATA, SULPHUR IODATUM, ANTIMONIUM TARTARICUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SAPONARIA OFFICINALIS ROOT; ECHINACEA ANGUSTIFOLIA; POTASSIUM BROMIDE; VIOLA TRICOLOR; SELENIUM; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; PULSATILLA VULGARIS; CALCIUM PICRATE; SULFUR IODIDE; ANTIMONY POTASSIUM TARTRATE 3; 3; 6; 3; 4; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 60512-0008_9af9beb9-620d-4311-bbbf-e343bc51b111 60512-0008 HUMAN OTC DRUG MENTAL ALERTNESS SUPPORT PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, GELSEMIUM SEMPERVIRENS, VALERIANA OFFICINALIS PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. PHOSPHORIC ACID; PICRIC ACID; GELSEMIUM SEMPERVIRENS ROOT; VALERIAN 9; 9; 6; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0009_a6d78c2e-6e72-442b-b9fe-5e71f01526f0 60512-0009 HUMAN OTC DRUG ARTHRITIS RELIEF CAUSTICUM, COLCHICUM AUTUMNALE, BENZOICUM ACIDUM, APIS MELLIFICA, ARSENICUM ALBUM, ARNICA MONTANA, NATRUM CARBONICUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CAUSTICUM; COLCHICUM AUTUMNALE BULB; BENZOIC ACID; APIS MELLIFERA; ARSENIC TRIOXIDE; ARNICA MONTANA; SODIUM CARBONATE 6; 4; 3; 6; 8; 7; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0010_e3e990ad-e27d-4e8c-9f78-afbe7e912d10 60512-0010 HUMAN OTC DRUG FATIGUE RELIEF ALFALFA, PHOSPHORUS, AVENA SATIVA, SELENIUM METALLICUM, AGNUS CASTUS, PHOSPHORICUM ACIDUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALFALFA WHOLE; PHOSPHORUS; AVENA SATIVA LEAF; SELENIUM; CHASTE TREE; PHOSPHORIC ACID 2; 6; 2; 9; 2; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0011_ea0ee15b-7740-4062-953d-0c20ea275aa7 60512-0011 HUMAN OTC DRUG INSOMNIA RELIEF PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. PASSIFLORA INCARNATA TOP; VALERIAN; AVENA SATIVA FLOWERING TOP; CUPRIC ACETATE; HYOSCYAMUS NIGER WHOLE 2; 2; 2; 9; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0012_39689f2d-b39d-4a50-aa18-901755aad773 60512-0012 HUMAN OTC DRUG MENOPAUSE SUPPORT LACHESIS MUTUS, AMYL NITROSUM, BRYONIA ALBA, AURUM METALLICUM, SANGUINARIA CANADENSIS PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. LACHESIS MUTA VENOM; AMYL NITRITE; BRYONIA ALBA ROOT; GOLD; SANGUINARIA CANADENSIS ROOT 10; 9; 4; 9; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0013_350d6c85-acf4-4966-a84e-380f57dba362 60512-0013 HUMAN OTC DRUG COUGH AND COLD RELIEF DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. DROSERA ROTUNDIFOLIA; ARSENIC TRIOXIDE; IPECAC; POTASSIUM DICHROMATE; ATROPA BELLADONNA WHOLE; PULSATILLA VULGARIS; MERCURIUS SOLUBILIS 3; 12; 6; 12; 4; 12; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0014_7ebc8729-d8bc-4883-a173-f3f2629808d4 60512-0014 HUMAN OTC DRUG ANXIETY/STRESS RELIEF ASA FOETIDA, IGNATIA AMARA, VALERIANA OFFICINALIS, AVENA SATIVA, ARGENTUM NITRICUM PELLET ORAL 20131023 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIAN; AVENA SATIVA FLOWERING TOP; SILVER NITRATE 3; 4; 3; 3; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0015_08e7e98e-92e0-40df-9bbb-9b0f220ae589 60512-0015 HUMAN OTC DRUG SINUS RELIEF ALLIUM CEPA, EUPHRASIA OFFICINALIS, STICTA PULMONARIA, HYDRASTIS CANADENSIS, THUJA OCCIDENTALIS, NUX VOMICA, HEPAR SULPHURIS CALCAREUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALLIUM CEPA WHOLE; EUPHRASIA STRICTA; LOBARIA PULMONARIA; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG; STRYCHNOS NUX-VOMICA SEED; CALCIUM SULFIDE 9; 9; 9; 3; 2; 9; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0016_e9bdcc75-13ac-4b1c-aa3e-f2a46ed289e8 60512-0016 HUMAN OTC DRUG WEIGHT CONTROL SUPPORT THYROIDINUM, RHAMNUS FRANGULA, FUCUS VESICULOSUS, KALI IODATUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. THYROID, OVINE; FRANGULA ALNUS BARK; FUCUS VESICULOSUS; POTASSIUM IODIDE 9; 3; 2; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0017_faaa2fab-8954-442f-a199-6b1fa40fa0b2 60512-0017 HUMAN OTC DRUG CANDIDA YEAST RELIEF BAPTISIA TINCTORIA, BRYONIA ALBA, ECHINACEA ANGUSTIFOLIA, THUJA OCCIDENTALIS, VISCUM ALBUM, CANDIDA ALBICANS PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM WHOLE; CANDIDA ALBICANS 4; 4; 4; 4; 4; 14 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0018_fd08ecac-8c58-42b1-8022-49a198d271e7 60512-0018 HUMAN OTC DRUG HEADACHE/MIGRAINE RELIEF CYCLAMEN EUROPAEUM, ANTIMONIUM CRUDUM, ALUMINA, LYCOPODIUM CLAVATUM, ARGENTUM NITRICUM, DIGITALIS PURPUREA, MELILOTUS OFFICINALIS, GLONOINUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CYCLAMEN PURPURASCENS TUBER; ANTIMONY TRISULFIDE; ALUMINUM OXIDE; LYCOPODIUM CLAVATUM SPORE; SILVER NITRATE; DIGITALIS PURPUREA WHOLE; MELILOTUS OFFICINALIS TOP; NITROGLYCERIN 4; 9; 9; 5; 9; 9; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-0050_d4441c45-4d56-4c57-ac7a-4da7791c9150 60512-0050 HUMAN OTC DRUG CALENDULA PLUS CALENDULA OFFICINALIS, ECHINACEA, HYPERICUM PERFORATUM, PHYTOLACCA DECANDRA, CANTHARIS, SULPHUR CREAM TOPICAL 19970326 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; PHYTOLACCA AMERICANA ROOT; LYTTA VESICATORIA; SULFUR 1; 1; 3; 3; 3; 3 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g N 20181231 60512-1001_23bba047-914d-4d20-a1c5-66a54b2c8eed 60512-1001 HUMAN OTC DRUG ACONITUM NAPELLUS ACONITUM NAPELLUS PELLET ORAL 19951024 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ACONITUM NAPELLUS 3 [hp_X]/1 N 20181231 60512-1002_19e754b3-7293-49e5-a700-a10b2b22f311 60512-1002 HUMAN OTC DRUG ALLIUM CEPA ALLIUM CEPA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ONION 1 [hp_X]/1 N 20181231 60512-1003_00d2c848-1dcb-469d-9d31-a5ac9ca1a201 60512-1003 HUMAN OTC DRUG ANTIMONIUM CRUDUM ANTIMONIUM CRUDUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ANTIMONY TRISULFIDE 3 [hp_X]/1 N 20181231 60512-1004_38c308cc-916f-49d6-9fa1-8c5f8f6caeb7 60512-1004 HUMAN OTC DRUG ANTIMONIUM TARTARICUM ANTIMONIUM TARTARICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ANTIMONY POTASSIUM TARTRATE 3 [hp_X]/1 N 20181231 60512-1005_ded831cc-2edb-45cc-aaf6-60d6223a614d 60512-1005 HUMAN OTC DRUG ARNICA MONTANA ARNICA MONTANA PELLET ORAL 19961011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA 3 [hp_X]/1 N 20181231 60512-1006_69d77078-dcce-44c5-8616-9df1c0a1a7b5 60512-1006 HUMAN OTC DRUG BELLADONNA BELLADONNA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ATROPA BELLADONNA 3 [hp_X]/1 N 20181231 60512-1007_82538f88-1e66-4df2-8ddc-377a0759248a 60512-1007 HUMAN OTC DRUG BRYONIA ALBA BRYONIA ALBA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC BRYONIA ALBA ROOT 3 [hp_X]/1 N 20181231 60512-1008_da89e93b-5dab-4717-a8ba-88f9b3a6fb8a 60512-1008 HUMAN OTC DRUG CALCAREA CARBONICA CALCAREA CARBONICA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. OYSTER SHELL CALCIUM CARBONATE, CRUDE 8 [hp_X]/1 N 20181231 60512-1009_0f960e66-2872-42f6-b081-c78664c81a87 60512-1009 HUMAN OTC DRUG CALCAREA PHOSPHORICA CALCAREA PHOSPHORICA PELLET ORAL 19951221 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC TRIBASIC CALCIUM PHOSPHATE 1 [hp_X]/1 N 20181231 60512-1010_2bf2a090-9000-46d3-b823-8a6fc69f6879 60512-1010 HUMAN OTC DRUG CALCAREA SULPHURICA CALCAREA SULPHURICA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CALCIUM SULFATE 6 [hp_X]/1 N 20181231 60512-1011_bbc42228-172a-4ac4-abee-d5d1737b993f 60512-1011 HUMAN OTC DRUG CARBO VEGETABILIS CARBO VEGETABILIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ACTIVATED CHARCOAL 1 [hp_X]/1 N 20181231 60512-1012_afed485f-30e7-4077-9543-3d245e090a7a 60512-1012 HUMAN OTC DRUG CAULOPHYLLUM THALICTROIDES CAULOPHYLLUM THALICTROIDES PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CAULOPHYLLUM THALICTROIDES ROOT 3 [hp_X]/1 N 20181231 60512-1013_d1cf6c38-1cae-4611-93be-02c412f48789 60512-1013 HUMAN OTC DRUG CHAMOMILLA CHAMOMILLA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MATRICARIA RECUTITA 1 [hp_X]/1 N 20181231 60512-1014_bb7ae816-f833-4c62-88a5-86b39b349299 60512-1014 HUMAN OTC DRUG COLOCYNTHIS COLOCYNTHIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CITRULLUS COLOCYNTHIS FRUIT PULP 3 [hp_X]/1 N 20181231 60512-1015_7baaa926-234f-488a-983e-e11c8758d6b8 60512-1015 HUMAN OTC DRUG DROSERA ROTUNDIFOLIA DROSERA ROTUNDIFOLIA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. DROSERA ROTUNDIFOLIA 1 [hp_X]/1 N 20181231 60512-1016_5cd9cd5e-f893-446d-abec-db99415bf4bf 60512-1016 HUMAN OTC DRUG DULCAMARA DULCAMARA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SOLANUM DULCAMARA TOP 2 [hp_X]/1 N 20181231 60512-1017_aeb4b3a7-164a-4862-83dd-be2aa0d067c0 60512-1017 HUMAN OTC DRUG EUPATORIUM PERFOLIATUM EUPATORIUM PERFOLIATUM PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. EUPATORIUM PERFOLIATUM FLOWERING TOP 1 [hp_X]/1 N 20181231 60512-1018_acb70833-8e89-4948-b3e2-9612c061435d 60512-1018 HUMAN OTC DRUG EUPHRASIA OFFICINALIS EUPHRASIA OFFICINALIS PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. EUPHRASIA STRICTA 1 [hp_X]/1 N 20181231 60512-1019_1189a602-8c41-468a-8592-21886773fc45 60512-1019 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERRUM PHOSPHORICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC FERROSOFERRIC PHOSPHATE 1 [hp_X]/1 N 20181231 60512-1020_b72e0200-e739-4552-9188-976bced2a0dc 60512-1020 HUMAN OTC DRUG GELSEMIUM SEMPERVIRENS GELSEMIUM SEMPERVIRENS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC GELSEMIUM SEMPERVIRENS ROOT 3 [hp_X]/1 N 20181231 60512-1021_cfec8084-1717-44d1-a2ed-4db9fddd4aa7 60512-1021 HUMAN OTC DRUG HAMAMELIS VIRGINIANA HAMAMELIS VIRGINIANA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]/1 N 20181231 60512-1022_a2505ba9-79d5-45ca-8f4a-ff4d952f4924 60512-1022 HUMAN OTC DRUG HEPAR SULPHURIS CALCAREUM HEPAR SULPHURIS CALCAREUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM SULFIDE 1 [hp_X]/1 N 20181231 60512-1023_6b6918de-6065-4927-8eaf-904410cb9426 60512-1023 HUMAN OTC DRUG HYPERICUM PERFORATUM HYPERICUM PERFORATUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC HYPERICUM PERFORATUM 3 [hp_X]/1 N 20181231 60512-1024_dbed9a33-71d8-437a-81d2-4df1e7e76d73 60512-1024 HUMAN OTC DRUG IGNATIA AMARA IGNATIA AMARA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC STRYCHNOS IGNATII SEED 3 [hp_X]/1 N 20181231 60512-1025_344e7e2f-9c20-4002-aa19-14ad07d6f5df 60512-1025 HUMAN OTC DRUG IPECACUANHA IPECACUANHA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC IPECAC 3 [hp_X]/1 N 20181231 60512-1030_ed84c011-d149-4e7a-91d2-595a66d0797d 60512-1030 HUMAN OTC DRUG LYCOPODIUM CLAVATUM LYCOPODIUM CLAVATUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC LYCOPODIUM CLAVATUM SPORE 1 [hp_X]/1 N 20181231 60512-1031_59e5feea-a351-48ca-8ba6-be8562eb722f 60512-1031 HUMAN OTC DRUG MERCURIUS VIVUS MERCURIUS VIVUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MERCURY 6 [hp_X]/1 N 20181231 60512-1032_715a9af0-5588-4cb8-aa49-9f7edbfdf026 60512-1032 HUMAN OTC DRUG NATRUM MURIATICUM NATRUM MURIATICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SODIUM CHLORIDE 1 [hp_X]/1 N 20181231 60512-1033_0d92dca3-7def-4d98-89f5-ee9995acca69 60512-1033 HUMAN OTC DRUG NATRUM PHOSPHORICUM NATRUM PHOSPHORICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SODIUM PHOSPHATE, DIBASIC 1 [hp_X]/1 N 20181231 60512-1034_70be8665-a7ba-498d-b7a8-355eac13109a 60512-1034 HUMAN OTC DRUG NATRUM SULPHURICUM NATRUM SULPHURICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SODIUM SULFATE 3 [hp_X]/1 N 20181231 60512-1035_bf3e089d-49f7-40de-9784-fd934554678d 60512-1035 HUMAN OTC DRUG NUX VOMICA NUX VOMICA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC STRYCHNOS NUX-VOMICA SEED 3 [hp_X]/1 N 20181231 60512-1036_9ba663c8-3830-49dd-8cd9-4de2d30983a8 60512-1036 HUMAN OTC DRUG PHOSPHORUS PHOSPHORUS PELLET ORAL 19951015 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC PHOSPHORUS 4 [hp_X]/1 N 20181231 60512-1038_5ecb5ce1-ed50-4d14-882c-6f05310a1637 60512-1038 HUMAN OTC DRUG PODOPHYLLUM PELTATUM PODOPHYLLUM PELTATUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. PODOPHYLLUM PELTATUM ROOT 3 [hp_X]/1 N 20181231 60512-1039_88ca8946-c398-4fa4-8ce9-59f69ad32a22 60512-1039 HUMAN OTC DRUG PULSATILLA PULSATILLA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. PULSATILLA VULGARIS 1 [hp_X]/1 N 20181231 60512-1040_0eb3bb86-39af-4dce-bb20-87da1168a281 60512-1040 HUMAN OTC DRUG RHUS TOXICODENDRON RHUS TOXICODENDRON PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC TOXICODENDRON PUBESCENS LEAF 3 [hp_X]/1 N 20181231 60512-1041_60bb4223-c894-4dbd-8b16-49b2424893b7 60512-1041 HUMAN OTC DRUG RUTA GRAVEOLENS RUTA GRAVEOLENS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/1 N 20181231 60512-1043_60678b2c-eb4e-4ae1-b028-00d0a22ebc98 60512-1043 HUMAN OTC DRUG SEPIA SEPIA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SEPIA OFFICINALIS JUICE 1 [hp_X]/1 N 20181231 60512-1044_0545154c-3f72-4a6c-ac16-168c210773fb 60512-1044 HUMAN OTC DRUG SILICEA SILICEA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SILICON DIOXIDE 2 [hp_X]/1 N 20181231 60512-1045_37786a64-82fd-482f-85ed-e25bc50b68e1 60512-1045 HUMAN OTC DRUG SPONGIA TOSTA SPONGIA TOSTA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SPONGIA OFFICINALIS SKELETON, ROASTED 1 [hp_X]/1 N 20181231 60512-1047_8c12e5a9-ceec-457b-a30c-690b132bc11f 60512-1047 HUMAN OTC DRUG SULPHUR SULPHUR PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SULFUR 1 [hp_X]/1 N 20181231 60512-1049_6be4d47a-5ec6-4027-98d5-e39fb2e8d555 60512-1049 HUMAN OTC DRUG THUJA OCCIDENTALIS THUJA OCCIDENTALIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC THUJA OCCIDENTALIS LEAFY TWIG 1 [hp_X]/1 N 20181231 60512-1052_d1b3eb33-24dc-46f0-8490-7ebb19e6f844 60512-1052 HUMAN OTC DRUG ARSENICUM ALBUM ARSENICUM ALBUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARSENIC TRIOXIDE 6 [hp_X]/1 N 20181231 60512-2001_41ea57f9-f5b8-45f1-ab11-e914fbc8f8be 60512-2001 HUMAN OTC DRUG HEADACHE/MIGRAINE RELIEF CYCLAMEN EUROPAEUM, ANTIMONIUM CRUDUM, ALUMINA, LYCOPODIUM CLAVATUM, GLONOINUM, ARGENTUM NITRICUM, DIGITALIS PURPUREA, MELILOTUS OFFICINALIS LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CYCLAMEN PURPURASCENS TUBER; ANTIMONY TRISULFIDE; ALUMINUM OXIDE; LYCOPODIUM CLAVATUM SPORE; SILVER NITRATE; DIGITALIS PURPUREA WHOLE; MELILOTUS OFFICINALIS TOP; NITROGLYCERIN 4; 9; 9; 5; 9; 9; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 60512-2002_41e3f5fe-3b70-4176-8a84-edc5b4d95c15 60512-2002 HUMAN OTC DRUG ALLERGY RELIEF ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, SABADILLA, STICTA PULMONARIA, CUPRUM METALLICUM, ARALIA RACEMOSA LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALLIUM CEPA WHOLE; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; COPPER; ARALIA RACEMOSA ROOT 6; 9; 6; 6; 6; 9; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 60512-2003_8d5300bb-ba7c-4c50-ba98-b23bd08b4dab 60512-2003 HUMAN OTC DRUG ANXIETY/STRESS ASA FOETIDA,IGNATIA AMARA,VALERIANA OFFICINALIS,AVENA SATIVA,ARGENTUM NITRICUM PELLET ORAL 20130523 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIAN; AVENA SATIVA FLOWERING TOP; SILVER NITRATE 3; 4; 3; 3; 9 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-2004_a71373d9-242b-47ab-9914-5dc8adee5144 60512-2004 HUMAN OTC DRUG CONSTIPATION RELIEF CROTON TIGLIUM, ALUMINA, ARGENTUM NITRICUM, PODOPHYLLUM PELTATUM, MAGNESIA CARBONICA LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CROTON TIGLIUM SEED; ALUMINUM OXIDE; SILVER NITRATE; PODOPHYLLUM PELTATUM ROOT; MAGNESIUM CARBONATE HYDROXIDE 9; 9; 9; 9; 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 60512-2005_3a8b630e-3b64-4750-9b91-67b08d7b97e9 60512-2005 HUMAN OTC DRUG COUGH AND COLD RELIEF DROSERA ROTUNDIFOLIA, ARSENICUM ALBUM, IPECACUANHA, KALI BICHROMICUM, BELLADONNA, PULSATILLA, MERCURIUS SOLUBILIS LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. DROSERA ROTUNDIFOLIA; ARSENIC TRIOXIDE; IPECAC; POTASSIUM DICHROMATE; ATROPA BELLADONNA WHOLE; PULSATILLA VULGARIS; MERCURIUS SOLUBILIS 9; 9; 9; 9; 9; 9; 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 60512-2006_64d81daf-7877-4f2a-9be5-7a9529368f81 60512-2006 HUMAN OTC DRUG FATIGUE RELIEF ALFALFA, PHOSPHORUS, AVENA SATIVA, SELENIUM METALLICUM, AGNUS CASTUS, PHOSPHORICUM ACIDUM LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALFALFA WHOLE; PHOSPHORUS; AVENA SATIVA LEAF; SELENIUM; CHASTE TREE; PHOSPHORIC ACID 2; 6; 2; 9; 2; 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 60512-2007_6a3399f7-681c-4566-9e43-bc226676938f 60512-2007 HUMAN OTC DRUG INDIGESTION/GAS RELIEF NUX VOMICA, BRYONIA, IPECACUANHA, SULPHUR, ARSENICUM ALBUM, PULSATILLA, ROBINIA PSEUDOACACIA LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. STRYCHNOS NUX-VOMICA SEED; BRYONIA ALBA ROOT; IPECAC; SULFUR; ARSENIC TRIOXIDE; PULSATILLA VULGARIS; ROBINIA PSEUDOACACIA BARK 9; 9; 9; 9; 9; 9; 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 60512-2008_23a1b9b2-e0a0-48b6-ae4e-e42aa659d4ad 60512-2008 HUMAN OTC DRUG INSOMNIA RELIEF PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVA, CUPRUM ACETICUM, HYOSCYAMUS NIGER LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. PASSIFLORA INCARNATA TOP; VALERIAN; AVENA SATIVA FLOWERING TOP; CUPRIC ACETATE; HYOSCYAMUS NIGER WHOLE 2; 2; 2; 9; 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 60512-2011_aea287d8-3016-4962-a633-5007d9c67071 60512-2011 HUMAN OTC DRUG ANXIETY/STRESS RELIEF ASA FOETIDA, IGNATIA AMARA, VALERIANA OFFICINALIS, AVENA SATIVA, ARGENTUM NITRICUM LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIAN; AVENA SATIVA FLOWERING TOP; SILVER NITRATE 3; 4; 3; 3; 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 60512-2012_adcdc496-ea0e-4d48-aaf8-7148fdb19de0 60512-2012 HUMAN OTC DRUG WEIGHT CONTROL SUPPORT THYROIDINUM, RHAMNUS FRANGULA, FUCUS VESICULOSUS, KALI IODATUM LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. THYROID, OVINE; FRANGULA ALNUS BARK; FUCUS VESICULOSUS; POTASSIUM IODIDE 9; 3; 2; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-2015_b73ab7f9-7233-40a7-9475-a4d993e82805 60512-2015 HUMAN OTC DRUG SMOKING WITHDRAWAL SUPPORT TABACUM, STAPHYSAGRIA, THUJA OCCIDENTALIS, LOBELIA INFLATA, MAGNESIA PHOSPHORICA LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. TOBACCO LEAF; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; LOBELIA INFLATA; MAGNESIUM PHOSPHATE, DIBASIC 15; 5; 3; 5; 9 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 60512-2016_09b3e423-0cc7-4b4a-ac22-9ee8a977d3a9 60512-2016 HUMAN OTC DRUG CAFFEINE WITHDRAWAL SUPPORT COFFEA TOSTA, STAPHYSAGRIA, GELSEMIUM SEMPERVIRENS, THUJA OCCIDENTALIS LIQUID ORAL 20131111 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. COFFEA ARABICA SEED, ROASTED; DELPHINIUM STAPHISAGRIA SEED; GELSEMIUM SEMPERVIRENS ROOT; THUJA OCCIDENTALIS LEAFY TWIG 3; 5; 5; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 60512-2020_c0535023-d30d-46a4-bc3a-543234984dce 60512-2020 HUMAN OTC DRUG EARACHE RELIEF FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, THUJA OCCIDENTALIS, SILICEA, MERCURIUS VIVUS, KALI PHOSPHORICUM, PYROGENIUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. FERRUM PHOSPHORICUM; CAPSICUM ANNUUM WHOLE; THUJA OCCIDENTALIS LEAFY TWIG; SILICON DIOXIDE; MERCURY; POTASSIUM PHOSPHATE, DIBASIC; RANCID BEEF 8; 5; 5; 8; 8; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6001_829accd1-2b87-4c65-8aca-3b1742105c3b 60512-6001 HUMAN OTC DRUG ASTHMA RESPIRATORY CARE REAL RELIEF ERIODICTYON CALIFORNICUM, IPECACUANHA, LOBELIA INFLATA, BELLADONNA, SOLIDAGO VIRGAUREA, SAMBUCUS NIGRA, CRATAEGUS TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ERIODICTYON CALIFORNICUM LEAF; IPECAC; LOBELIA INFLATA; ATROPA BELLADONNA; SOLIDAGO VIRGAUREA FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; HAWTHORN LEAF WITH FLOWER 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6002_8cb329ea-0f3a-49be-bcce-40ca44a7c5a6 60512-6002 HUMAN OTC DRUG ASTHMA RESPIRATORY CARE NIGHTTIME REAL RELIEF ERIODICTYON CALIFORNICUM, IPECACUANHA, LOBELIA INFLATA, CHAMOMILLA, BELLADONNA, COFFEA CRUDA, SOLIDAGO VIRGAUREA, SAMBUCUS NIGRA, CRATAEGUS TABLET, CHEWABLE ORAL 20120711 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ERIODICTYON CALIFORNICUM LEAF; IPECAC; LOBELIA INFLATA; MATRICARIA RECUTITA; ATROPA BELLADONNA; ARABICA COFFEE BEAN; SOLIDAGO VIRGAUREA FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; HAWTHORN LEAF WITH FLOWER 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6005_7ed09afb-c5d4-4dfe-bb5b-10a6d7d45bdb 60512-6005 HUMAN OTC DRUG GAS AND BLOATING REAL RELIEF COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; DIOSCOREA VILLOSA TUBER 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6006_49f20d50-bb80-4bb5-a916-647b029862d0 60512-6006 HUMAN OTC DRUG NATURCOKSINUM FLU RELIEF DAYTIME REAL RELIEF ANAS BARBARIAE HEPATIS ET CORDIS EXTRACTUM TABLET, CHEWABLE ORAL 20120710 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/1 N 20181231 60512-6007_62b5a401-e18e-45a4-8d7e-dd3c0570f206 60512-6007 HUMAN OTC DRUG NATURCOKSINUM FLU RELIEF NIGHTTIME REAL RELIEF ANAS BARBARIAE HEPATIS ET CORDIS EXTRACTUM,CHAMOMILLA,COFFEA CRUDA TABLET, CHEWABLE ORAL 20120710 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; MATRICARIA RECUTITA; ARABICA COFFEE BEAN 200; 4; 4 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 60512-6009_9e770f5d-cbc0-4eb9-8093-cbf96900693a 60512-6009 HUMAN OTC DRUG ECZEMA REAL RELIEF FUMARIA OFFICINALIS, NATRUM MURIATICUM, AGARICUS MUSCARIUS, PETROLEUM, SEPIA, KALI ARSENICOSUM, ALUMINA TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. FUMARIA OFFICINALIS FLOWERING TOP; SODIUM CHLORIDE; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; KEROSENE; SEPIA OFFICINALIS JUICE; POTASSIUM ARSENITE ANHYDROUS; ALUMINUM OXIDE 6; 6; 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 60512-6010_7a89dc56-e0f8-474c-8db5-4c3b37464df5 60512-6010 HUMAN OTC DRUG PSORIASIS REAL RELIEF SULPHUR, ARSENICUM ALBUM, ALUMEN, MAGNESIA SULPHURICUM, NATRUM SULPHURICUM TABLET, CHEWABLE ORAL 20120711 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SULFUR; ARSENIC TRIOXIDE; POTASSIUM ALUM; MAGNESIUM SULFATE HEPTAHYDRATE; SODIUM SULFATE 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6011_bbde7bf1-d690-469c-aa87-488dcc927071 60512-6011 HUMAN OTC DRUG MALE ERECTILE ENHANCER REAL RELIEF DAMIANA, PHOSPHORICUM ACIDUM, ARALIA QUINQUEFOLIA, SELENIUM METALLICUM, YOHIMBINUM TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC TURNERA DIFFUSA LEAFY TWIG; PHOSPHORIC ACID; AMERICAN GINSENG; SELENIUM; YOHIMBINE 3; 3; 1; 8; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 N 20181231 60512-6012_aaae5100-1d12-4faa-ab32-6a9122367810 60512-6012 HUMAN OTC DRUG FEMALE LIBIDO REAL RELIEF AGNUS CASTUS, VALERIANA, AMBRA GRISEA, DAMIANA, SELENIUM, LYCOPODIUM TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CHASTE TREE; VALERIAN; AMBERGRIS; TURNERA DIFFUSA LEAFY TWIG; SELENIUM; LYCOPODIUM CLAVATUM SPORE 4; 2; 6; 4; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6013_600dedde-85ab-4364-99ca-037aab9c960f 60512-6013 HUMAN OTC DRUG HEMORRHOIDS WITHOUT COMPLICATIONS REAL RELIEF PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA TABLET, CHEWABLE ORAL 20120711 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC HORSE CHESTNUT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PAEONIA OFFICINALIS ROOT; COLLINSONIA CANADENSIS ROOT; TEUCRIUM MARUM; VERBASCUM THAPSUS; PEUMUS BOLDUS LEAF; SULFUR; ALOE 4; 4; 8; 8; 8; 8; 4; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6015_6b43f8e8-80da-47a9-80ea-cc70f683028f 60512-6015 HUMAN OTC DRUG FIBROMYALGIA REAL RELIEF CALCAREA PHOSPHORICA, IGNATIA AMARA, CAUSTICUM, RHUS TOXICODENDRON, MAGNESIA PHOSPHORICA, BRYONIA, ARNICA MONTANA TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC TRIBASIC CALCIUM PHOSPHATE; STRYCHNOS IGNATII SEED; CAUSTICUM; TOXICODENDRON PUBESCENS LEAF; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; BRYONIA ALBA ROOT; ARNICA MONTANA 7; 9; 7; 7; 7; 7; 9 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 60512-6018_d791f9a2-d862-4f8f-873e-6e6fe8f679b0 60512-6018 HUMAN OTC DRUG DIARRHEA REAL RELIEF CINCHONA OFFICINALIS, BRYONIA, CHAMOMILLA, COLOCYNTHIS, IPECACUANHA, BELLADONNA TABLET, CHEWABLE ORAL 20121121 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CINCHONA OFFICINALIS BARK; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; ATROPA BELLADONNA 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6020_50bd9c5e-5274-4e64-b17e-006621e978af 60512-6020 HUMAN OTC DRUG CANDIDA YEAST REAL RELIEF BAPTISIA TINCTORIA, BRYONIA, ECHINACEA ANGUSTIFOLIA, THUJA OCCIDENTALIS, VISCUM ALBUM TABLET, CHEWABLE ORAL 20121214 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6021_c44cc151-29b2-4666-887c-1301ba68348b 60512-6021 HUMAN OTC DRUG ARSENICUM METALLICUM ARSENICUM METALLICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARSENIC 8 [hp_X]/1 N 20181231 60512-6025_69bc0114-19d9-4a4f-aee3-fafd1799f8c7 60512-6025 HUMAN OTC DRUG ARNICA PLUS MUSCLE AND JOINT PAIN REAL RELIEF ARNICA, HYPERICUM PERFORATUM TABLET, CHEWABLE ORAL 20121121 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; HYPERICUM PERFORATUM 6; 6 [hp_X]/1; [hp_X]/1 N 20181231 60512-6026_3205c0d2-b044-4859-a90c-4cf1026170a4 60512-6026 HUMAN OTC DRUG LEG CRAMPS REAL RELIEF MAGNESIA MURIATICA, MAGNESIA PHOSPHORICA, PLUMBUM ACETICUM, KALI PHOSPHORICUM, AMBRA GRISEA TABLET, CHEWABLE ORAL 20121121 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MAGNESIUM CHLORIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; LEAD; POTASSIUM PHOSPHATE, DIBASIC; AMBERGRIS 6; 6; 8; 6; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6030_1ea40849-40eb-4be7-b343-52f1fd5dc57c 60512-6030 HUMAN OTC DRUG ALLERGY REAL RELIEF ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, EUPHRASIA OFFICINALIS, SABADILLA, STICTA PULMONARIA, ARALIA RACEMOSA, CUPRUM METALLICUM TABLET, CHEWABLE ORAL 20121025 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ONION; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; ARALIA RACEMOSA ROOT; COPPER 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6031_cbb0883f-f17b-408d-a847-8fd45ab55bb4 60512-6031 HUMAN OTC DRUG HEADACHE AND MIGRAINE REAL RELIEF CYCLAMEN EUROPAEUM, ANTIMONIUM CRUDUM, ALUMINA, LYCOPODIUM CLAVATUM, ALUMINA, LYCOPODIUM CLAVATUM, ARGENTUM NITRICUM, DIGITALIS PURPUREA, MELILOTUS OFFICINALIS, GLONOINUM TABLET, CHEWABLE ORAL 20121025 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CYCLAMEN PURPURASCENS TUBER; ANTIMONY TRISULFIDE; ALUMINUM OXIDE; LYCOPODIUM CLAVATUM SPORE; SILVER NITRATE; DIGITALIS; MELILOTUS OFFICINALIS TOP; NITROGLYCERIN 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6032_59e5548e-a0dd-4cbc-92bf-718665cc26db 60512-6032 HUMAN OTC DRUG TINNITUS REAL RELIEF KALI BROMATUM, CINCHONA OFFICINALIS, SULPHUR, DULCAMARA, HYDRASTIS CANADENSIS, ARNICA MONTANA, BRYONIA CAUSTICUM TABLET, CHEWABLE ORAL 20121025 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM BROMIDE; CINCHONA OFFICINALIS BARK; SULFUR; SOLANUM DULCAMARA TOP; GOLDENSEAL; ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6033_19aa8211-d411-442a-a709-4155bb3c6725 60512-6033 HUMAN OTC DRUG HEMORRHOIDS REAL RELIEF AESCULUS HIPPOCASTANUM, HAMAMELIS VIRGINIANA, PAEONIA OFFICINALIS, COLLINSONIA CANADENSIS, TEUCRIEUM MARUM, VERBASCUM THAPSUS, BOLDO, SULPHUR, ALOE SOCOTRINA TABLET, CHEWABLE ORAL 20121025 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC HORSE CHESTNUT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PAEONIA OFFICINALIS ROOT; COLLINSONIA CANADENSIS ROOT; TEUCRIUM MARUM; VERBASCUM THAPSUS; PEUMUS BOLDUS LEAF; SULFUR; ALOE 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6036_80203b5e-6a1c-43fa-a3d4-1a1b561e9a8b 60512-6036 HUMAN OTC DRUG ARTHRITIS PAIN REAL RELIEF CAUSTICUM, COLCHICUM AUTUMNAL, BENZOICUM ACIDUM, APIS MELLIFICA, ARNICA MONTANA, NATRUM CARBONICUM TABLET, CHEWABLE ORAL 20121025 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CAUSTICUM; COLCHICUM AUTUMNALE BULB; BENZOIC ACID; APIS MELLIFERA; ARNICA MONTANA; SODIUM CARBONATE 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6037_d6010783-9f0b-4afb-a561-e9af3619cfa1 60512-6037 HUMAN OTC DRUG INDIGESTION REAL RELIEF LYCOPODIUM CLAVATUM, CARDUUS MARIANUS, CHELIDONIUM MAJUS, BOLDO, NUX VOMICA TABLET, CHEWABLE ORAL 20120711 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC LYCOPODIUM CLAVATUM SPORE; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; PEUMUS BOLDUS LEAF; STRYCHNOS NUX-VOMICA SEED 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6038_46b1f8f0-8e08-4461-b48e-4af84ea2bdaf 60512-6038 HUMAN OTC DRUG SEVERE HEMORRHOIDS REAL RELIEF PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA TABLET, CHEWABLE ORAL 20120725 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT; NITRIC ACID; SULFUR; PODOPHYLLUM; RUTA GRAVEOLENS FLOWERING TOP; GRAPHITE; APIS MELLIFERA; HORSE CHESTNUT; STRYCHNOS NUX-VOMICA SEED 8; 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-6039_87b835b6-ecf0-4d02-8009-012c8755b748 60512-6039 HUMAN OTC DRUG CALCAREA FLUORICA CALCAREA FLUORICA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CALCIUM FLUORIDE 8 [hp_X]/1 N 20181231 60512-6055_1057b468-8692-456d-a852-e84c23859fd0 60512-6055 HUMAN OTC DRUG CORALLIUM RUBRUM CORALLIUM RUBRUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CORALLIUM RUBRUM EXOSKELETON 8 [hp_X]/1 N 20181231 60512-6060_70a3bc2c-b0da-4781-8faa-3f99470e7467 60512-6060 HUMAN OTC DRUG CUPRUM METALLICUM CUPRUM METALLICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. COPPER 8 [hp_X]/1 N 20181231 60512-6075_4e3ecd7f-d9d4-4049-8538-bc6fd16fbe41 60512-6075 HUMAN OTC DRUG GRAPHITES GRAPHITES PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. GRAPHITE 1 [hp_X]/1 N 20181231 60512-6152_b67a6747-5ec3-4c79-9768-13c45b1bbc21 60512-6152 HUMAN OTC DRUG ACETALDEHYDE ACETALDEHYDE PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACETALDEHYDE 6 [hp_X]/1 N 20181231 60512-6153_8f298fcc-ced3-41f6-81f5-ba4bf0ac6ac9 60512-6153 HUMAN OTC DRUG ACETANILIDUM ACETANILIDUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACETANILIDE 3 [hp_X]/1 N 20181231 60512-6154_8d4824b5-d184-45f3-800b-3915a0463671 60512-6154 HUMAN OTC DRUG ACETICUM ACIDUM ACETICUM ACIDUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACETIC ACID 3 [hp_X]/1 N 20181231 60512-6155_b1155d8b-98d8-49c7-bec2-aca2ef9bd2af 60512-6155 HUMAN OTC DRUG ACONITINUM ACONITINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACONITINE 6 [hp_X]/1 N 20181231 60512-6157_0787ef5a-1f3d-405f-8048-4d1bf1a821b4 60512-6157 HUMAN OTC DRUG ADRENALINUM ADRENALINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. EPINEPHRINE 6 [hp_X]/1 N 20181231 60512-6158_f0c6c22e-405e-4840-8696-e28246cee59d 60512-6158 HUMAN OTC DRUG ADRENOCORTICOTROPHIN ADRENOCORTICOTROPHIN PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CORTICOTROPIN 6 [hp_X]/1 N 20181231 60512-6160_245a5025-e294-4e5f-9db8-6321aba4156e 60512-6160 HUMAN OTC DRUG AGARICINUM AGARICINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AGARICIC ACID 3 [hp_X]/1 N 20181231 60512-6161_e030028c-1409-4ff7-a96d-f5b4ae8f4000 60512-6161 HUMAN OTC DRUG ALLOXANUM ALLOXANUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALLOXAN 6 [hp_X]/1 N 20181231 60512-6162_84732b57-f1c1-40aa-81ec-904a5f940296 60512-6162 HUMAN OTC DRUG ALUMEN ALUMEN PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALUM, POTASSIUM 3 [hp_X]/1 N 20181231 60512-6163_13ae0d37-c5f1-4fa7-a1c9-5387e82c38f4 60512-6163 HUMAN OTC DRUG ALUMINIUM MURIATICUM ALUMINIUM MURIATICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALUMINUM CHLORIDE 3 [hp_X]/1 N 20181231 60512-6171_9c42283b-af8f-46d6-b824-c3c26167064e 60512-6171 HUMAN OTC DRUG AMMONIUM MURIATICUM AMMONIUM MURIATICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMMONIUM CHLORIDE 1 [hp_X]/1 N 20181231 60512-6173_95763f2e-79ff-410b-8ef9-caeac33b2029 60512-6173 HUMAN OTC DRUG AMMONIUM PHOSPHORICUM AMMONIUM PHOSPHORICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMMONIUM PHOSPHATE, DIBASIC 3 [hp_X]/1 N 20181231 60512-6176_de300e22-fcd8-4c97-917e-d04682f0bc75 60512-6176 HUMAN OTC DRUG AMMONIUM VALERIANICUM AMMONIUM VALERIANICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMMONIUM VALERATE 2 [hp_X]/1 N 20181231 60512-6179_2dec9d72-244b-4ff0-b11f-6d8d70d9d959 60512-6179 HUMAN OTC DRUG AMYL NITROSUM AMYL NITROSUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMYL NITRITE 6 [hp_X]/1 N 20181231 60512-6180_6393da1d-5b31-4974-9c36-cab67cadec8d 60512-6180 HUMAN OTC DRUG ANILINUM ANILINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ANILINE 4 [hp_X]/1 N 20181231 60512-6183_b3769206-d0e3-4f92-b3ae-cad202d46f73 60512-6183 HUMAN OTC DRUG ANTIPYRINUM ANTIPYRINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ANTIPYRINE 6 [hp_X]/1 N 20181231 60512-6184_a7f9defd-737a-4c5b-bc4a-b1a1e13dce1a 60512-6184 HUMAN OTC DRUG APIOLUM APIOLUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. APIOLE (PARSLEY) 3 [hp_X]/1 N 20181231 60512-6188_bb5abab6-718e-4296-ae4b-818f72839a62 60512-6188 HUMAN OTC DRUG ARBUTINUM ARBUTINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARBUTIN 3 [hp_X]/1 N 20181231 60512-6189_1f0aa0d9-9f29-42f8-82c6-659d662c3d06 60512-6189 HUMAN OTC DRUG ARGENTUM NITRICUM ARGENTUM NITRICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SILVER NITRATE 6 [hp_X]/1 N 20181231 60512-6203_1425368a-1c7d-4dbc-bd0b-34d1d25fb20a 60512-6203 HUMAN OTC DRUG BENZOICUM ACIDUM BENZOICUM ACIDUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. BENZOIC ACID 2 [hp_X]/1 N 20181231 60512-6205_ad394cb5-1035-4263-8251-6bedd29812ac 60512-6205 HUMAN OTC DRUG BORAX BORAX PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SODIUM BORATE 1 [hp_X]/1 N 20181231 60512-6228_3f9ec2bf-dee2-4b39-b752-5254c3164e9b 60512-6228 HUMAN OTC DRUG CAUSTICUM CAUSTICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CAUSTICUM 3 [hp_X]/1 N 20181231 60512-6281_074cee98-48a2-4938-b3c2-143cb2999336 60512-6281 HUMAN OTC DRUG GLONOINUM GLONOINUM PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. NITROGLYCERIN 6 [hp_X]/1 N 20181231 60512-6294_4b2ec878-b074-4dc2-a1e6-01f2d6491453 60512-6294 HUMAN OTC DRUG KALI BICHROMICUM KALI BICHROMICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. POTASSIUM DICHROMATE 3 [hp_X]/1 N 20181231 60512-6346_b7df6b0c-e377-415e-a047-ce1eb7a3f0b7 60512-6346 HUMAN OTC DRUG NATRUM PHOSPHORICUM NATRUM PHOSPHORICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SODIUM PHOSPHATE, DIBASIC 1 [hp_X]/1 N 20181231 60512-6350_f2e878ab-8e59-45a2-b58f-fe53fa28e2d3 60512-6350 HUMAN OTC DRUG NATRUM SULPHURICUM NATRUM SULPHURICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SODIUM SULFATE 1 [hp_X]/1 N 20181231 60512-6435_45084b0d-210b-4fc5-afa7-2f83fb28924e 60512-6435 HUMAN OTC DRUG ABELMOSCHUS ABELMOSCHUS PELLET ORAL 20131114 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ABELMOSCHUS MOSCHATUS SEED 6 [hp_X]/1 N 20181231 60512-6436_26314bf2-eb27-4cf6-ae2c-8f88d8bfd670 60512-6436 HUMAN OTC DRUG ABIES CANADENSIS ABIES CANADENSIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. TSUGA CANADENSIS BARK 1 [hp_X]/1 N 20181231 60512-6437_cb69ea24-38d9-46c6-8774-2fed033fd3af 60512-6437 HUMAN OTC DRUG ABIES NIGRA ABIES NIGRA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. PICEA MARIANA RESIN 1 [hp_X]/1 N 20181231 60512-6438_658754ec-2058-474e-be50-213a232a763c 60512-6438 HUMAN OTC DRUG ABROTANUM ABROTANUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARTEMISIA ABROTANUM FLOWERING TOP 1 [hp_X]/1 N 20181231 60512-6439_f9cce9a3-dd8b-405b-98aa-2cd91784f5dc 60512-6439 HUMAN OTC DRUG ABSINTHIUM ABSINTHIUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARTEMISIA ABSINTHIUM WHOLE 3 [hp_X]/1 N 20181231 60512-6440_86d40b92-82fe-4b2d-b77f-6c82223e54b3 60512-6440 HUMAN OTC DRUG ACALYPHA INDICA ACALYPHA INDICA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACALYPHA INDICA 1 [hp_X]/1 N 20181231 60512-6441_30ebedda-0132-43a0-99ba-2b4808dc4663 60512-6441 HUMAN OTC DRUG ACHYRANTHES CALEA ACHYRANTHES CALEA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. IRESINE CALEA 1 [hp_X]/1 N 20181231 60512-6442_4c5cf727-c17e-48bb-903f-cee51f84df0e 60512-6442 HUMAN OTC DRUG ACONITUM FEROX ACONITUM FEROX PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACONITUM FEROX ROOT 3 [hp_X]/1 N 20181231 60512-6443_54ea7052-a368-4ff3-b2d4-6132e440ea49 60512-6443 HUMAN OTC DRUG ACONITUM LYCOCTONUM ACONITUM LYCOCTONUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACONITUM LYCOCTONUM 3 [hp_X]/1 N 20181231 60512-6445_8202e548-8750-4c6b-8ec6-d2183f613565 60512-6445 HUMAN OTC DRUG ACONITUM, RADIX ACONITUM, RADIX PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACONITUM NAPELLUS ROOT 6 [hp_X]/1 N 20181231 60512-6446_60f25122-5278-42e1-afd7-aa46de3c341c 60512-6446 HUMAN OTC DRUG ACTAEA SPICATA ACTAEA SPICATA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACTAEA SPICATA ROOT 1 [hp_X]/1 N 20181231 60512-6447_2002e89d-bceb-43e8-8107-b441358926eb 60512-6447 HUMAN OTC DRUG ADONIS VERNALIS ADONIS VERNALIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ADONIS VERNALIS 3 [hp_X]/1 N 20181231 60512-6448_b0af0423-03b6-4618-9ce9-c149f221bba6 60512-6448 HUMAN OTC DRUG AESCULUS GLABRA AESCULUS GLABRA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AESCULUS GLABRA NUT 1 [hp_X]/1 N 20181231 60512-6449_017dc74e-47b0-468f-8c51-3a3c506a8081 60512-6449 HUMAN OTC DRUG AESCULUS HIPPOCASTANUM AESCULUS HIPPOCASTANUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. HORSE CHESTNUT 1 [hp_X]/1 N 20181231 60512-6450_91caf524-af9e-417d-9050-84826200bc46 60512-6450 HUMAN OTC DRUG AETHUSA CYNAPIUM AETHUSA CYNAPIUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AETHUSA CYNAPIUM 3 [hp_X]/1 N 20181231 60512-6452_5363556d-2e64-4c04-8b5b-6f62493ff223 60512-6452 HUMAN OTC DRUG AGARICUS CAMPESTRIS AGARICUS CAMPESTRIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AGARICUS CAMPESTRIS VAR. CAMPESTRIS WHOLE 2 [hp_X]/1 N 20181231 60512-6454_ffee31ff-b713-4850-9f8c-6f2d19cdb7d6 60512-6454 HUMAN OTC DRUG AGARICUS EMETICUS AGARICUS EMETICUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. RUSSULA EMETICA WHOLE 2 [hp_X]/1 N 20181231 60512-6455_1ae931f3-6a93-45a6-be60-67473d2fb461 60512-6455 HUMAN OTC DRUG AGARICUS MUSCARIUS AGARICUS MUSCARIUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMANITA MUSCARIA VAR. MUSCARIA 2 [hp_X]/1 N 20181231 60512-6456_081723c6-fdf2-4aa9-95f1-66b5e0d7ef15 60512-6456 HUMAN OTC DRUG AGARICUS PANTHERINUS AGARICUS PANTHERINUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMANITA PANTHERINA WHOLE 2 [hp_X]/1 N 20181231 60512-6457_f17d47dd-e08a-490a-96e3-a51d5d31dce0 60512-6457 HUMAN OTC DRUG AGARICUS PHALLOIDES AGARICUS PHALLOIDES PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMANITA PHALLOIDES WHOLE 6 [hp_X]/1 N 20181231 60512-6461_4c82d2bc-f43c-4cfd-977b-ba3912306d51 60512-6461 HUMAN OTC DRUG AGAVE AMERICANA AGAVE AMERICANA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AGAVE AMERICANA LEAF 1 [hp_X]/1 N 20181231 60512-6462_bfff88a0-48f0-43a5-9bf0-a5a4dc1eebc1 60512-6462 HUMAN OTC DRUG AGAVE TEQUILANA AGAVE TEQUILANA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AGAVE TEQUILANA TOP 1 [hp_X]/1 N 20181231 60512-6463_d0a5ae04-c5b2-4a8e-bd5a-f0ee02bb1445 60512-6463 HUMAN OTC DRUG AGNUS CASTUS AGNUS CASTUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. VITEX AGNUS-CASTUS WHOLE 1 [hp_X]/1 N 20181231 60512-6464_f454b404-70e1-45ec-b9c7-8f01bbad3831 60512-6464 HUMAN OTC DRUG AGRAPHIS NUTANS AGRAPHIS NUTANS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. HYACINTHOIDES NON-SCRIPTA 1 [hp_X]/1 N 20181231 60512-6465_edb220ed-d981-4924-96e5-a3fa8525a396 60512-6465 HUMAN OTC DRUG AGRIMONIA EUPATORIA AGRIMONIA EUPATORIA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AGRIMONIA EUPATORIA 1 [hp_X]/1 N 20181231 60512-6466_e25962a9-1d3d-487d-bc22-2af85b6e1af3 60512-6466 HUMAN OTC DRUG AGROSTEMMA GITHAGO AGROSTEMMA GITHAGO PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AGROSTEMMA GITHAGO SEED 1 [hp_X]/1 N 20181231 60512-6467_3172bd7a-5fce-463b-b78f-103cc7627c01 60512-6467 HUMAN OTC DRUG AILANTHUS GLANDULOSUS AILANTHUS GLANDULOSUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AILANTHUS ALTISSIMA FLOWERING TWIG 1 [hp_X]/1 N 20181231 60512-6468_e9917566-8144-4222-9409-308b09ebd5ca 60512-6468 HUMAN OTC DRUG ALETRIS FARINOSA ALETRIS FARINOSA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALETRIS FARINOSA ROOT 1 [hp_X]/1 N 20181231 60512-6469_10c1ea72-3eaf-44b1-8639-4c1aded50551 60512-6469 HUMAN OTC DRUG ALFALFA ALFALFA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALFALFA WHOLE 1 [hp_X]/1 N 20181231 60512-6472_1e03e993-b0ac-47d3-8244-f879648c9c1c 60512-6472 HUMAN OTC DRUG ALLIUM SATIVUM ALLIUM SATIVUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALLIUM SATIVUM WHOLE 1 [hp_X]/1 N 20181231 60512-6473_c159ee04-1389-4ff8-9cd9-e8989fd0ca1f 60512-6473 HUMAN OTC DRUG ALNUS GLUTINOSA ALNUS GLUTINOSA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALNUS GLUTINOSA BARK 1 [hp_X]/1 N 20181231 60512-6475_464b4639-3bb8-4ccc-80a9-db911108be7e 60512-6475 HUMAN OTC DRUG ALOE ALOE PELLET ORAL 20131114 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALOE VERA LEAF 6 [hp_X]/1 N 20181231 60512-6476_39cf168a-58ba-458f-b1e4-5573b527fb5d 60512-6476 HUMAN OTC DRUG ALSTONIA CONSTRICTA ALSTONIA CONSTRICTA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALSTONIA CONSTRICTA BARK 1 [hp_X]/1 N 20181231 60512-6478_a535cc62-d0ff-4ea7-ab1a-5748218bbacc 60512-6478 HUMAN OTC DRUG ALTHAEA OFFICINALIS ALTHAEA OFFICINALIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ALTHAEA OFFICINALIS ROOT 1 [hp_X]/1 N 20181231 60512-6479_3f54f17f-a819-4667-bbb9-df8ab29aae80 60512-6479 HUMAN OTC DRUG AMBROSIA ARTEMISIAEFOLIA AMBROSIA ARTEMISIAEFOLIA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMBROSIA ARTEMISIIFOLIA 1 [hp_X]/1 N 20181231 60512-6486_615c8812-ce9e-4cfa-a54c-9a8c474cb7f6 60512-6486 HUMAN OTC DRUG ANACARDIUM ORIENTALE ANACARDIUM ORIENTALE PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SEMECARPUS ANACARDIUM JUICE 3 [hp_X]/1 N 20181231 60512-6489_ccd29e50-5bf0-496a-bff5-6ea9f954406f 60512-6489 HUMAN OTC DRUG ANATHERUM MURICATUM ANATHERUM MURICATUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CHRYSOPOGON ZIZANIOIDES ROOT 1 [hp_X]/1 N 20181231 60512-6497_f793144f-441c-4d0c-be63-2a5cfd3d972b 60512-6497 HUMAN OTC DRUG ANGUSTURA VERA ANGUSTURA VERA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ANGOSTURA BARK 4 [hp_X]/1 N 20181231 60512-6502_d1b868c8-b10f-450d-b3f7-3ad65b4b2ec5 60512-6502 HUMAN OTC DRUG APIUM GRAVEOLENS APIUM GRAVEOLENS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CELERY SEED 1 [hp_X]/1 N 20181231 60512-6503_adda7254-4a6d-4a61-a376-eada358fec7f 60512-6503 HUMAN OTC DRUG APOCYNUM ANDROSAEMIFOLIUM APOCYNUM ANDROSAEMIFOLIUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. APOCYNUM ANDROSAEMIFOLIUM ROOT 3 [hp_X]/1 N 20181231 60512-6506_642e745b-5ef2-402f-a54b-ea0232d147f6 60512-6506 HUMAN OTC DRUG NATURCOKSINUM AM PM REAL RELIEF ANAS BARBARIAE, CHAMOMILLA, COFFEA CRUDA KIT 20120713 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC N 20181231 60512-6507_3430f8ac-d334-44d4-9173-aaa9b953b608 60512-6507 HUMAN OTC DRUG ARALIA QUINQUEFOLIA ARALIA QUINQUEFOLIA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMERICAN GINSENG 1 [hp_X]/1 N 20181231 60512-6510_81e5f69f-607b-4195-8055-51d2bb816d68 60512-6510 HUMAN OTC DRUG ARGEMONE MEXICANA ARGEMONE MEXICANA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARGEMONE MEXICANA WHOLE 1 [hp_X]/1 N 20181231 60512-6511_62aed54c-6e0f-474e-97b5-5ae7d1e11d35 60512-6511 HUMAN OTC DRUG ARISTOLOCHIA CLEMATITIS ARISTOLOCHIA CLEMATITIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARISTOLOCHIA CLEMATITIS ROOT 6 [hp_X]/1 N 20181231 60512-6513_7ab6052c-25de-439c-acc6-71e907a91f1a 60512-6513 HUMAN OTC DRUG ARISTOLOCHIA SERPENTARIA ARISTOLOCHIA SERPENTARIA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARISTOLOCHIA SERPENTARIA ROOT 6 [hp_X]/1 N 20181231 60512-6516_cce6f006-bc05-4f02-81c9-d5ffc2367a1a 60512-6516 HUMAN OTC DRUG ARTEMISIA VULGARIS ARTEMISIA VULGARIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARTEMISIA VULGARIS ROOT 1 [hp_X]/1 N 20181231 60512-6517_568a5235-7841-485a-87cf-5d7b66ba66a7 60512-6517 HUMAN OTC DRUG ARUM DRACONTIUM ARUM DRACONTIUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARISAEMA DRACONTIUM ROOT 1 [hp_X]/1 N 20181231 60512-6520_9855c435-ac0e-4c89-a60c-622b74a0208d 60512-6520 HUMAN OTC DRUG ARUM TRIPHYLLUM ARUM TRIPHYLLUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARISAEMA TRIPHYLLUM ROOT 1 [hp_X]/1 N 20181231 60512-6522_a09236ca-b811-4f5e-a8a5-7144af001b79 60512-6522 HUMAN OTC DRUG ASAFOETIDA ASAFOETIDA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ASAFETIDA 1 [hp_X]/1 N 20181231 60512-6534_ae229cf1-f37b-4aab-adc8-03d841e196a3 60512-6534 HUMAN OTC DRUG AVENA SATIVA AVENA SATIVA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AVENA SATIVA FLOWERING TOP 1 [hp_X]/1 N 20181231 60512-6537_6f55f71e-9921-4d01-9213-28eec3fdb6a0 60512-6537 HUMAN OTC DRUG BAPTISIA TINCTORIA BAPTISIA TINCTORIA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. BAPTISIA TINCTORIA ROOT 1 [hp_X]/1 N 20181231 60512-6541_d6d268f8-a9ed-429f-ac4c-26ca154f5e6a 60512-6541 HUMAN OTC DRUG BELLIS PERENNIS BELLIS PERENNIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. BELLIS PERENNIS 1 [hp_X]/1 N 20181231 60512-6545_0bb58850-1977-4f8f-aa19-7cfa2ee21935 60512-6545 HUMAN OTC DRUG BERBERIS VULGARIS BERBERIS VULGARIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. BERBERIS VULGARIS ROOT BARK 1 [hp_X]/1 N 20181231 60512-6548_71d50e02-9d75-4036-afd4-e903b95ac34a 60512-6548 HUMAN OTC DRUG BOLDO BOLDO PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. PEUMUS BOLDUS LEAF 1 [hp_X]/1 N 20181231 60512-6558_e64e2a8f-f797-4149-8b82-ca11e3c83650 60512-6558 HUMAN OTC DRUG CACTUS GRANDIFLORUS CACTUS GRANDIFLORUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SELENICEREUS GRANDIFLORUS STEM 3 [hp_X]/1 N 20181231 60512-6561_7dcb699c-d773-4a5e-9c55-1161c3597ecb 60512-6561 HUMAN OTC DRUG CALENDULA OFFICINALIS CALENDULA OFFICINALIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/1 N 20181231 60512-6566_87ed270f-d45a-487b-8cb0-fca9be8a55ff 60512-6566 HUMAN OTC DRUG CAPSICUM ANNUUM CAPSICUM ANNUUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CAPSICUM 3 [hp_X]/1 N 20181231 60512-6568_cfea5887-e609-4387-9df4-801ec35d7674 60512-6568 HUMAN OTC DRUG CARDUUS MARIANUS CARDUUS MARIANUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. MILK THISTLE 1 [hp_X]/1 N 20181231 60512-6582_fdcb1441-b829-4ddf-a5b9-1a51624261ae 60512-6582 HUMAN OTC DRUG CETRARIA ISLANDICA CETRARIA ISLANDICA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CETRARIA ISLANDICA SUBSP. ISLANDICA 1 [hp_X]/1 N 20181231 60512-6585_5f047a70-8592-422b-94f8-242231383f91 60512-6585 HUMAN OTC DRUG CHELIDONIUM MAJUS CHELIDONIUM MAJUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CHELIDONIUM MAJUS 1 [hp_X]/1 N 20181231 60512-6598_d95b1a8c-20bc-4887-83b4-ab8bff08f8cf 60512-6598 HUMAN OTC DRUG CIMICIFUGA RACEMOSA CIMICIFUGA RACEMOSA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ACTAEA CIMICIFUGA ROOT 1 [hp_X]/1 N 20181231 60512-6599_e6ea7416-1dda-43a7-aeff-9ef4a065eca4 60512-6599 HUMAN OTC DRUG ANTHEMIS NOBILIS ANTHEMIS NOBILIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CHAMOMILE 1 [hp_X]/1 N 20181231 60512-6600_b3174f9c-8641-4390-8209-9579d3233b76 60512-6600 HUMAN OTC DRUG CINCHONA OFFICINALIS CINCHONA OFFICINALIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CINCHONA OFFICINALIS BARK 2 [hp_X]/1 N 20181231 60512-6608_c3ac8e12-a1a6-4174-abf5-b71a338e5bdf 60512-6608 HUMAN OTC DRUG COCCULUS INDICUS COCCULUS INDICUS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ANAMIRTA COCCULUS SEED 4 [hp_X]/1 N 20181231 60512-6611_fa025acb-aadf-4771-961d-03bfee48bccc 60512-6611 HUMAN OTC DRUG COFFEA CRUDA COFFEA CRUDA PELLET ORAL 19970729 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARABICA COFFEE BEAN 1 [hp_X]/1 N 20181231 60512-6613_a85c7e5a-7cbb-4401-aa37-27b0c24cde96 60512-6613 HUMAN OTC DRUG COLCHICUM AUTUMNALE COLCHICUM AUTUMNALE PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. COLCHICUM AUTUMNALE BULB 3 [hp_X]/1 N 20181231 60512-6614_b726d3cc-0589-4abd-9d8f-3f4e0df31693 60512-6614 HUMAN OTC DRUG COLLINSONIA CANADENSIS COLLINSONIA CANADENSIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. COLLINSONIA CANADENSIS ROOT 1 [hp_X]/1 N 20181231 60512-6615_c3afa8e0-ccb7-43ea-9fa4-ac5071bcf382 60512-6615 HUMAN OTC DRUG COLOCYNTHIS COLOCYNTHIS PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CITRULLUS COLOCYNTHIS FRUIT PULP 3 [hp_X]/1 N 20181231 60512-6618_a75374e2-a98b-4267-9716-2481e5374a41 60512-6618 HUMAN OTC DRUG CONIUM MACULATUM CONIUM MACULATUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CONIUM MACULATUM FLOWERING TOP 3 [hp_X]/1 N 20181231 60512-6634_777fd8ce-4c4c-4cba-a31b-2b0b2131b830 60512-6634 HUMAN OTC DRUG CYCLAMEN EUROPAEUM CYCLAMEN EUROPAEUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CYCLAMEN PURPURASCENS TUBER 3 [hp_X]/1 N 20181231 60512-6643_b428c3f0-14c5-441d-a208-d39d3ad9e236 60512-6643 HUMAN OTC DRUG DIGITALIS PURPUREA DIGITALIS PURPUREA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. DIGITALIS 8 [hp_X]/1 N 20181231 60512-6644_c2a9b088-a42d-4b81-ac1a-0a1ad8319599 60512-6644 HUMAN OTC DRUG DIOSCOREA VILLOSA DIOSCOREA VILLOSA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. DIOSCOREA VILLOSA ROOT 1 [hp_X]/1 N 20181231 60512-6646_d3bab2f8-aa0b-4573-805f-dd1b2e6612d0 60512-6646 HUMAN OTC DRUG DOLICHOS PRURIENS DOLICHOS PRURIENS PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. MUCUNA PRURIENS FRUIT TRICHOME 1 [hp_X]/1 N 20181231 60512-6650_efb05de7-53bb-4623-8dc3-8cdb296e2087 60512-6650 HUMAN OTC DRUG ECHINACEA ANGUSTIFOLIA ECHINACEA ANGUSTIFOLIA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ECHINACEA ANGUSTIFOLIA 1 [hp_X]/1 N 20181231 60512-6651_72bfae31-b7e6-4ca2-87d4-d7e54efa9b18 60512-6651 HUMAN OTC DRUG ECHINACEA PURPUREA ECHINACEA PURPUREA PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ECHINACEA PURPUREA 1 [hp_X]/1 N 20181231 60512-6669_80b01d6e-6ad8-4f8e-82dd-600f50b117fb 60512-6669 HUMAN OTC DRUG EUCALYPTUS GLOBULUS EUCALYPTUS GLOBULUS PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. EUCALYPTUS GLOBULUS LEAF 1 [hp_X]/1 N 20181231 60512-6695_700fa09c-5049-427a-a655-a91b2281a9fd 60512-6695 HUMAN OTC DRUG FUCUS VESICULOSUS FUCUS VESICULOSUS PELLET ORAL 20131118 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. FUCUS VESICULOSUS 1 [hp_X]/1 N 20181231 60512-6780_7085e720-9fd4-4314-b945-832464d51f22 60512-6780 HUMAN OTC DRUG LEDUM PALUSTRE LEDUM PALUSTRE PELLET ORAL 19970131 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC LEDUM PALUSTRE TWIG 1 [hp_X]/1 N 20181231 60512-6997_2880f07e-526d-409b-8cbd-3dad8561ca5c 60512-6997 HUMAN OTC DRUG SYZYGIUM JAMBOLANUM SYZYGIUM JAMBOLANUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. SYZYGIUM JAMBOS SEED 3 [hp_X]/1 N 20181231 60512-6998_0426b0d8-40d4-4319-8290-a14780b45a32 60512-6998 HUMAN OTC DRUG TABACUM TABACUM PELLET ORAL 19990413 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC TOBACCO LEAF 3 [hp_X]/1 N 20181231 60512-7101_cafb8adf-a8f6-46f1-8183-552091dffe21 60512-7101 HUMAN OTC DRUG AMBRA GRISEA AMBRA GRISEA PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. AMBERGRIS 2 [hp_X]/1 N 20181231 60512-7120_f72d8665-37bd-4543-a919-23b6556c5057 60512-7120 HUMAN OTC DRUG COCCUS CACTI COCCUS CACTI PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. DACTYLOPIUS COCCUS WHOLE 1 [hp_X]/1 N 20181231 60512-7126_357e9ef5-2455-4304-b7cc-7e4f1f4ca2e7 60512-7126 HUMAN OTC DRUG INFLUENZINUM INFLUENZINUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. INFLUENZA A VIRUS; INFLUENZA B VIRUS 9; 9 [hp_C]/1; [hp_C]/1 N 20181231 60512-7155_e5ab9e70-07ac-497d-90b5-a33aca3da380 60512-7155 HUMAN OTC DRUG CINA CINA PELLET ORAL 19970714 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARTEMISIA CINA FLOWER 1 [hp_X]/1 N 20181231 60512-8001_10adc95b-429b-4b77-9afd-ee7435778e1d 60512-8001 HUMAN OTC DRUG AURUM METALLICUM AURUM METALLICUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. GOLD 8 [hp_X]/1 N 20181231 60512-8002_e7ba8913-2369-4373-8eb3-e8dd160f998f 60512-8002 HUMAN OTC DRUG ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM PELLET ORAL 19951011 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/1 N 20181231 60512-8010_316be821-1be3-465f-8097-722e90bf094b 60512-8010 HUMAN OTC DRUG CALCAREA FLUORICA CALCAREA FLUORICA TABLET, CHEWABLE ORAL 20140228 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM FLUORIDE 6 [hp_X]/1 N 20181231 60512-8011_e0c8a652-2ab7-4b14-a066-7df2b88e0fff 60512-8011 HUMAN OTC DRUG CALCAREA FLUORICA CALCAREA FLUORICA TABLET, CHEWABLE ORAL 20140228 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM FLUORIDE 12 [hp_X]/1 N 20181231 60512-8012_4f652d69-4f9a-4b95-924f-610f154118e6 60512-8012 HUMAN OTC DRUG CALCAREA PHOSPHORICA CALCAREA PHOSPHORICA TABLET, CHEWABLE ORAL 20140313 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM PHOSPHATE 6 [hp_X]/1 N 20181231 60512-8014_791ae06f-a790-43a7-ab3b-fc5594f20b07 60512-8014 HUMAN OTC DRUG CALCAREA PHOSPHORICA CALCAREA PHOSPHORICA TABLET, CHEWABLE ORAL 20140313 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM PHOSPHATE 12 [hp_X]/1 N 20181231 60512-8015_9cb94a8b-ecd6-42af-ad86-f074fe1336c0 60512-8015 HUMAN OTC DRUG CALCAREA SULPHURICA CALCAREA SULPHURICA TABLET, CHEWABLE ORAL 20140314 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM SULFATE 6 [hp_X]/1 N 20181231 60512-8016_41bdf49f-9ee2-47d7-938d-8df8be6e1a11 60512-8016 HUMAN OTC DRUG CALCAREA SULPHURICA CALCAREA SULPHURICA TABLET, CHEWABLE ORAL 20140314 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM SULFATE 12 [hp_X]/1 N 20181231 60512-8017_59db0646-8bbb-49b3-95de-e3280d6a4855 60512-8017 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERRUM PHOSPHORICUM TABLET, CHEWABLE ORAL 20140314 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC FERRUM PHOSPHORICUM 6 [hp_X]/1 N 20181231 60512-8018_a8a08a52-8622-4516-b9e3-7ec7e3056f63 60512-8018 HUMAN OTC DRUG FERRUM PHOSPHORICUM FERRUM PHOSPHORICUM TABLET, CHEWABLE ORAL 20140314 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC FERRUM PHOSPHORICUM 12 [hp_X]/1 N 20181231 60512-8019_da8a2430-88cb-41b7-98a0-3643f50f4c7c 60512-8019 HUMAN OTC DRUG KALI MURIATICUM KALI MURIATICUM TABLET, CHEWABLE ORAL 20140317 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM CHLORIDE 6 [hp_X]/1 N 20181231 60512-8020_65d98509-6652-4f21-8412-f9d0decd8020 60512-8020 HUMAN OTC DRUG KALI MURIATICUM KALI MURIATICUM TABLET, CHEWABLE ORAL 20140317 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM CHLORIDE 12 [hp_X]/1 N 20181231 60512-8021_cc8bcc3f-549b-4315-8791-bc310343e87f 60512-8021 HUMAN OTC DRUG KALI PHOSPHORICUM KALI PHOSPHORICUM TABLET, CHEWABLE ORAL 20140317 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM PHOSPHATE, DIBASIC 6 [hp_X]/1 N 20181231 60512-8022_fbf9d194-3782-41dc-9382-9b9aa8e5515a 60512-8022 HUMAN OTC DRUG KALI PHOSPHORICUM KALI PHOSPHORICUM TABLET, CHEWABLE ORAL 20140317 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM PHOSPHATE, DIBASIC 12 [hp_X]/1 N 20181231 60512-8023_e07c4129-87d7-4ffb-9259-561568930826 60512-8023 HUMAN OTC DRUG KALI SULPHURICUM KALI SULPHURICUM TABLET, CHEWABLE ORAL 20140319 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM SULFATE 6 [hp_X]/1 N 20181231 60512-8024_84b41571-41a8-4318-a283-bd095d76a5db 60512-8024 HUMAN OTC DRUG KALI SULPHURICUM KALI SULPHURICUM TABLET, CHEWABLE ORAL 20140319 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC POTASSIUM SULFATE 12 [hp_X]/1 N 20181231 60512-8025_b9dc06ac-a4f3-44ee-8c89-a4bedb7dce8d 60512-8025 HUMAN OTC DRUG MAGNESIA PHOSPHORICA MAGNESIA PHOSPHORICA TABLET, CHEWABLE ORAL 20140319 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MAGNESIUM PHOSPHATE, DIBASIC 6 [hp_X]/1 N 20181231 60512-8026_f0010789-6707-4842-953c-f3f074448d63 60512-8026 HUMAN OTC DRUG MAGNESIA PHOSPHORICA MAGNESIA PHOSPHORICA TABLET, CHEWABLE ORAL 20140319 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MAGNESIUM PHOSPHATE, DIBASIC 12 [hp_X]/1 N 20181231 60512-8027_b0bc737c-b9a8-4c42-adf9-50f8ca6ae246 60512-8027 HUMAN OTC DRUG NATRUM MURIATICUM NATRUM MURIATICUM TABLET, CHEWABLE ORAL 20140320 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SODIUM CHLORIDE 6 [hp_X]/1 N 20181231 60512-8028_b8d4a434-96e7-4fc0-b4b2-8259374a5ff0 60512-8028 HUMAN OTC DRUG NATRUM MURIATICUM NATRUM MURIATICUM TABLET, CHEWABLE ORAL 20140320 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SODIUM CHLORIDE 12 [hp_X]/1 N 20181231 60512-8029_68e922da-3699-4296-aa98-684e70479672 60512-8029 HUMAN OTC DRUG NATRUM PHOSPHORICUM NATRUM PHOSPHORICUM TABLET, CHEWABLE ORAL 20140320 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SODIUM PHOSPHATE, DIBASIC 6 [hp_X]/1 N 20181231 60512-8030_0152ac21-7ce4-47e4-88f4-e52f60f257d9 60512-8030 HUMAN OTC DRUG NATRUM PHOSPHORICUM NATRUM PHOSPHORICUM TABLET, CHEWABLE ORAL 20140320 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SODIUM PHOSPHATE, DIBASIC 12 [hp_X]/1 N 20181231 60512-8031_73e128ba-b414-4d87-89f6-b5ee06032d6a 60512-8031 HUMAN OTC DRUG NATRUM SULPHURICUM NATRUM SULPHURICUM TABLET, CHEWABLE ORAL 20140325 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SODIUM SULFATE 6 [hp_X]/1 N 20181231 60512-8032_532924b7-d092-4bef-a044-ef748b59d0d3 60512-8032 HUMAN OTC DRUG NATRUM SULPHURICUM NATRUM SULPHURICUM TABLET, CHEWABLE ORAL 20140325 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SODIUM SULFATE 12 [hp_X]/1 N 20181231 60512-8033_3a93db3e-8251-48d1-85a5-ea63f9448c61 60512-8033 HUMAN OTC DRUG SILICEA SILICEA TABLET, CHEWABLE ORAL 20140326 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SILICON DIOXIDE 6 [hp_X]/1 N 20181231 60512-8034_cc338d30-14b0-4763-8e55-cac2c7521ae1 60512-8034 HUMAN OTC DRUG SILICEA SILICEA TABLET, CHEWABLE ORAL 20140326 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC SILICON DIOXIDE 12 [hp_X]/1 N 20181231 60512-8035_336b7627-d812-449a-883b-a59c92992a0b 60512-8035 HUMAN OTC DRUG DIAMITE CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA TABLET, CHEWABLE ORAL 20140328 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM FLUORIDE; CALCIUM PHOSPHATE; CALCIUM SULFATE; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; SILICON DIOXIDE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-8036_600bb4d6-f18a-48a3-b89b-dcc12e7cb4b5 60512-8036 HUMAN OTC DRUG DIAMITE CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA TABLET, CHEWABLE ORAL 20140328 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM FLUORIDE; CALCIUM PHOSPHATE; CALCIUM SULFATE; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; SILICON DIOXIDE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-8037_e21074b8-af22-4a03-8b6b-c2d1aa0f6e21 60512-8037 HUMAN OTC DRUG DIAMITE 12 CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA TABLET, CHEWABLE ORAL 20150612 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALCIUM FLUORIDE; CALCIUM PHOSPHATE; CALCIUM SULFATE; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; SILICON DIOXIDE 6; 6; 6; 5; 4; 3; 6; 3; 6; 3; 3; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-9011_1f56545f-3b70-41da-a1cb-8fa35ac8dec5 60512-9011 HUMAN OTC DRUG COUGH AND COLD KIDS RELIEF DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, STANNUM METALLICUM SYRUP ORAL 20120808 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC DROSERA ROTUNDIFOLIA; ARNICA MONTANA; BRYONIA ALBA ROOT; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; ATROPA BELLADONNA; PROTORTONIA CACTI; TIN 1; 3; 3; 3; 1; 3; 3; 3 [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL N 20181231 60512-9021_234c0f45-415b-4c31-a8e7-2ec2034e1858 60512-9021 HUMAN OTC DRUG COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, STANNUM METALLICUM, CHAMOMILLA, COFFEA CRUDA SYRUP ORAL 20110228 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC DROSERA ROTUNDIFOLIA; ARNICA MONTANA; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; ATROPA BELLADONNA; PROTORTONIA CACTI; TIN; MATRICARIA RECUTITA; ARABICA COFFEE BEAN 1; 3; 3; 1; 3; 3; 3; 4; 4 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL N 20181231 60512-9054_cbb42dcc-3ad3-42be-89f8-64942e5ffab2 60512-9054 HUMAN OTC DRUG TINNITUS RELIEF KALIUM BROMATUM, NUX VOMICA, CHINA RUBRA, SULPHUR, SANGUINARIA CANADENSIS, DULCAMARA, HYDRASTIS CANADENSIS, ARNICA MONTANA, BRYONIA ALBA, CAUSTICUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. POTASSIUM BROMIDE; STRYCHNOS NUX-VOMICA SEED; CINCHONA OFFICINALIS BARK; SULFUR; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA STEM; GOLDENSEAL; ARNICA MONTANA; BRYONIA ALBA ROOT; CAUSTICUM 3; 4; 4; 4; 4; 3; 3; 4; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-9055_24655d36-7d53-4133-9cb4-eed02b8099c5 60512-9055 HUMAN OTC DRUG DIARRHEA RELIEF CHINA, BRYONIA ALBA, CHAMOMILLA, COLOCYNTHIS, IPECA, BELLADONNA, POTENTILLA ANSERINA PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CINCHONA OFFICINALIS BARK; BRYONIA ALBA ROOT; MATRICARIA CHAMOMILLA WHOLE; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; ATROPA BELLADONNA WHOLE; POTENTILLA ANSERINA WHOLE 3; 4; 3; 4; 4; 3; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-9056_5ab5a64f-b7b6-43df-81e8-c81badc6d214 60512-9056 HUMAN OTC DRUG FIBROMYALGIA RELIEF CALCAREA PHOSPHORICA, IGNATIA AMARA, CAUSTICUM, RHUS TOXICODENDRON, MAGNESIA PHOSPHORICA, BRYONIA ALBA, ARNICA MONTANA, HYPERICUM, CANTHARIS, KALI BICHROMICUM, PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. CALCIUM PHOSPHATE; STRYCHNOS IGNATII SEED; CAUSTICUM; TOXICODENDRON RADICANS LEAF; MAGNESIUM PHOSPHATE, DIBASIC; BRYONIA ALBA ROOT; ARNICA MONTANA; HYPERICUM PERFORATUM; LYTTA VESICATORIA; POTASSIUM DICHROMATE 7; 9; 7; 7; 7; 7; 9; 9; 9; 9 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 60512-9057_c117c170-0ce5-49e4-b7f1-f7e604d52811 60512-9057 HUMAN OTC DRUG DIGESTION RELIEF DOLICHOS PRURIENS, LYCOPODIUM CLAVATUM, LEPTANDRA VIRGINICA, CARDUUS MARIANUS, CHELIDONIUM MAJUS, BOLDO PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. MUCUNA PRURIENS FRUIT TRICHOME; LYCOPODIUM CLAVATUM SPORE; VERONICASTRUM VIRGINICUM ROOT; MILK THISTLE; CHELIDONIUM MAJUS; PEUMUS BOLDUS LEAF 3; 3; 3; 3; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-9058_e74a6496-0c32-40e5-8f83-52a8759d4688 60512-9058 HUMAN OTC DRUG ARNICA RELIEF ARNICA MONTANA 10X, 30X, 100X PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARNICA MONTANA 10 [hp_X]/1 N 20181231 60512-9059_c7c9c1f3-e944-487e-b2ef-fa51d9335e13 60512-9059 HUMAN OTC DRUG HEMORRHOIDS RELIEF AESCULUS HIPPOCASTANUM, HAMAMELIS VIRGINIANA, PAEONIA OFFICINALIS, COLLINSONIA, TEUCRIUM MARUM, VERBASCUM, BOLDO, SULPHUR, SODIUM NITRATE, RATANHIA, ACIDUM NITRICUM, NATRUM MURIATICUM, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, APIS MELLIFICA PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. HORSE CHESTNUT; WITCH HAZEL; PAEONIA OFFICINALIS ROOT; COLLINSONIA CANADENSIS ROOT; TEUCRIUM MARUM; VERBASCUM THAPSUS; PEUMUS BOLDUS LEAF; SULFUR; SODIUM NITRATE; KRAMERIA LAPPACEA ROOT; NITRIC ACID; SODIUM CHLORIDE; PODOPHYLLUM PELTATUM ROOT; RUTA GRAVEOLENS FLOWERING TOP; APIS MELLIFERA 1; 1; 3; 3; 3; 3; 1; 4; 3; 3; 8; 8; 4; 8; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-9060_7fc50292-4009-4941-b5e0-29e05f03f92c 60512-9060 HUMAN OTC DRUG TEETHING KIDS RELIEF CHAMOMILLA, ARNICA MONTANA, BORAX, HYPERICUM PERFORATUM LIQUID ORAL 20080818 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MATRICARIA RECUTITA; ARNICA MONTANA; SODIUM BORATE; HYPERICUM PERFORATUM 5; 5; 5; 5 [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL N 20181231 60512-9061_ed44f9b2-1193-4bb5-b09a-c1e4e63a9507 60512-9061 HUMAN OTC DRUG COUGH AND COLD KIDS RELIEF DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM SYRUP ORAL 20080818 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA ROOT; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; ATROPA BELLADONNA; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; TIN 1; 3; 3; 3; 1; 3; 3; 3; 3 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL N 20181231 60512-9062_b8f22738-2143-48d4-92aa-6fb0834f4bb3 60512-9062 HUMAN OTC DRUG FLU KIDS RELIEF ANAS BARBARIAE HEPATIS ET CORDIS EXTRACTUM LIQUID ORAL 20090406 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/25mL N 20181231 60512-9063_15df66c3-bb76-467a-a732-5fc39b46c47e 60512-9063 HUMAN OTC DRUG EARACHE KIDS RELIEF FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, PYROGENIUM, ARSENICUM ALBUM, BELLADONNA LIQUID ORAL 20080818 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC FERRUM PHOSPHORICUM; RED PEPPER; RANCID BEEF; ARSENIC TRIOXIDE; ATROPA BELLADONNA 30; 30; 30; 30; 30 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 60512-9064_2d234e85-3d18-4e0b-942d-3246137b711d 60512-9064 HUMAN OTC DRUG CALM KIDS RELIEF ASAFOETIDA, IGNATIA AMARA, VALERIANA OFFICINALIS, AVENA SATIVA, ARGENTUM NITRICUM, TARENTULA HISPANA, HYOSCYAMUS NIGER, PAEONIA OFFICINALIS, STRAMONIUM, COCCULUS INDICUS SYRUP ORAL 20080818 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIAN; AVENA SATIVA FLOWERING TOP; SILVER NITRATE; LYCOSA TARANTULA; HYOSCYAMUS NIGER; PAEONIA OFFICINALIS ROOT; DATURA STRAMONIUM; ANAMIRTA COCCULUS SEED 8; 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL N 20181231 60512-9065_694ab851-5a46-4cd3-bda1-bbd72024369c 60512-9065 HUMAN OTC DRUG COLIC KIDS RELIEF COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA LIQUID ORAL 20080818 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; DIOSCOREA VILLOSA ROOT 6; 6; 6; 6 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 60512-9068_80142f3a-0bf0-4a08-92c6-b3806f8b0d3c 60512-9068 HUMAN OTC DRUG JET LAG RELIEF ARNICA MONTANA, BELLIS PERENNIS, CHAMOMILLA, IPECACUANHA, LYCOPODIUM CLAVATUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ARNICA MONTANA; BELLIS PERENNIS; MATRICARIA CHAMOMILLA WHOLE; IPECAC; LYCOPODIUM CLAVATUM SPORE 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-9069_7e30579a-e6fc-4ce8-a1c2-0434412227de 60512-9069 HUMAN OTC DRUG TRAVEL SICKNESS RELIEF COCCULUS INDICUS, VINCA MINOR, VALERIANA OFFICINALIS, PULSATILLA, NITROGLYCERIN, PLUMBUM ACETICUM, ARGENTUM NITRICUM, ARTEMISIA VULGARIS PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ANAMIRTA COCCULUS SEED; VINCA MINOR; VALERIAN; PULSATILLA VULGARIS; NITROGLYCERIN; LEAD ACETATE; SILVER NITRATE; ARTEMISIA VULGARIS ROOT 8; 3; 6; 4; 6; 8; 6; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60512-9077_a02a5db7-ffe3-4c8f-8bf2-0b146856e42a 60512-9077 HUMAN OTC DRUG ALLERGY KIDS RELIEF PULSATILLA, ALLIUM CEPA, ARSENICUM ALBUM, NUX VOMICA, EUPHRASIA OFFICINALIS, SABADILLA, STICTA PULMONARIA, ARALIA RACEMOSA, CUPRUM METALLICUM LIQUID ORAL 20090420 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC PULSATILLA VULGARIS; ONION; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; ARALIA RACEMOSA ROOT; COPPER 8; 6; 8; 6; 6; 6; 6; 6; 8 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 60512-9079_658bde6b-3541-4f37-ae1f-e76e275bd2e1 60512-9079 HUMAN OTC DRUG PAIN AND FEVER KIDS RELIEF ARNICA MONTANA, FERRUM PHOSPHORICUM, HYPERICUM PERFORATUM, BELLADONNA, THUJA OCCIDENTALIS, LEDUM PALUSTRE LIQUID ORAL 20100510 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; ATROPA BELLADONNA; THUJA OCCIDENTALIS LEAFY TWIG; LEDUM PALUSTRE TWIG 8; 8; 8; 8; 8; 8 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 60512-9081_79e3fd0b-314d-4b65-8e2d-e05098cc2064 60512-9081 HUMAN OTC DRUG COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CHAMOMILLA, COFFEA CRUDA SYRUP ORAL 20110228 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; ATROPA BELLADONNA; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; TIN; MATRICARIA RECUTITA; ARABICA COFFEE BEAN 1; 3; 3; 1; 3; 3; 3; 3; 4; 4 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL N 20181231 60512-9082_fe7c506b-3d1e-4766-9785-2333ecf7de00 60512-9082 HUMAN OTC DRUG ARNICA PLUS ARNICA MONTANA, HYPERICUM PERFORATUM CREAM TOPICAL 20110601 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; HYPERICUM PERFORATUM 1; 1 [hp_X]/50g; [hp_X]/50g N 20181231 60512-9083_b7de38ee-a474-4986-bc94-f1ff734349f3 60512-9083 HUMAN OTC DRUG GAS AND COLIC KIDS RELIEF COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA LIQUID ORAL 20110822 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; DIOSCOREA VILLOSA ROOT 6; 6; 6; 6 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 60512-9084_b289eac0-5658-4271-b797-5b87e576248b 60512-9084 HUMAN OTC DRUG COUGH AND COLD NIGHTTIME REAL RELIEF DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, STANNUM METALLICUM, CHAMOMILLA, COFFEA CRUDA SYRUP ORAL 20120321 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC DROSERA ROTUNDIFOLIA; ARNICA MONTANA; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; ATROPA BELLADONNA; PROTORTONIA CACTI; TIN; MATRICARIA RECUTITA; ARABICA COFFEE BEAN 1; 3; 3; 1; 3; 3; 3; 4; 4 [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL N 20181231 60512-9085_34856a8b-feaa-44c6-b51a-baf650365e8d 60512-9085 HUMAN OTC DRUG Cough and Cold Real Relief DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, BELLADONNA, COCCUS CACTI, CORRALLIUM RUBRUM, STANNUM METALLICUM SYRUP ORAL 20120417 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC DROSERA ROTUNDIFOLIA; ARNICA MONTANA; BRYONIA ALBA ROOT; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; ATROPA BELLADONNA; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; TIN 1; 3; 3; 3; 1; 3; 3; 3; 3 [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL; [hp_C]/250mL N 20181231 60512-9086_46668cbd-c581-4c65-94a8-4e19b5b041ef 60512-9086 HUMAN OTC DRUG KIDS RELIEF ARNICA ARNICA MONTANA, HYPERICUM PERFORATUM CREAM TOPICAL 20120315 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; HYPERICUM PERFORATUM 1; 1 [hp_X]/50g; [hp_X]/50g N 20181231 60512-9087_94d1feca-06e9-4245-8440-2e8826fd57c3 60512-9087 HUMAN OTC DRUG KIDS RELIEF CALENDULA CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHYTOLACCA DECANDRA, CANTHARIS, SULPHUR CREAM TOPICAL 20120315 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; PHYTOLACCA AMERICANA ROOT; LYTTA VESICATORIA; SULFUR 1; 1; 3; 3; 3; 3 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g N 20181231 60512-9150_a462ba79-eda0-411b-98d1-84f2d636577a 60512-9150 HUMAN OTC DRUG APIS MELLIFICA APIS MELLIFICA PELLET ORAL 20111130 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC APIS MELLIFERA 1 [hp_X]/1 N 20181231 60512-9151_bf3ee20b-6d71-4ed3-8de2-a0df5a4a8961 60512-9151 HUMAN OTC DRUG CANTHARIS CANTHARIS PELLET ORAL 20111130 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC LYTTA VESICATORIA 3 [hp_X]/1 N 20181231 60512-9152_a5928f0b-b6e7-44af-a9ef-1196d1c7ab78 60512-9152 HUMAN OTC DRUG MAGNESIA PHOSPHORICA MAGNESIA PHOSPHORICA PELLET ORAL 20111130 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 1 [hp_X]/1 N 20181231 60512-9163_45a6f39c-d835-4f00-a5f6-1982f143f7e1 60512-9163 HUMAN OTC DRUG KIDS RELIEF EAR RELIEF FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, PYROGENIUM, ARSENICUM ALBUM, BELLADONNA LIQUID ORAL 20140115 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC FERRUM PHOSPHORICUM; CAPSICUM ANNUUM WHOLE; RANCID BEEF; ARSENIC TRIOXIDE; ATROPA BELLADONNA 30; 30; 30; 30; 30 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 60512-9164_c815a73e-e392-48f5-a2dd-a663d46297dc 60512-9164 HUMAN OTC DRUG WITH CALMING EFFECT KIDS RELIEF ASAFOETIDA, IGNATIA AMARA, VALERIANA OFFICINALIS, AVENA SATIVA, ARGENTUM NITRICUM, HYOSCYAMUS NIGER, PAEONIA OFFICINALIS, STRAMONIUM, COCCULUS INDICUS SYRUP ORAL 20130507 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ASAFETIDA; STRYCHNOS IGNATII SEED; VALERIAN; AVENA SATIVA FLOWERING TOP; SILVER NITRATE; HYOSCYAMUS NIGER; PAEONIA OFFICINALIS ROOT; DATURA STRAMONIUM; ANAMIRTA COCCULUS SEED 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL N 20181231 60512-9200_46a095f6-bc10-4ce2-af09-bc4fcfc2e7ea 60512-9200 HUMAN OTC DRUG Gas and Colic Kids Relief Baby COLOCYNTHIS, MAGNESIA PHOSPHORICA, CHAMOMILLA, DIOSCOREA VILLOSA LIQUID ORAL 20160816 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; DIOSCOREA VILLOSA ROOT 6; 6; 6; 6 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 60512-9201_43ba057b-7be2-454e-a587-ce5176ef7509 60512-9201 HUMAN OTC DRUG Pain and Fever Kids Relief Baby ARNICA MONTANA, FERRUM PHOSPHORICUM, HYPERICUM PERFORATUM, BELLADONNA, THUJA OCCIDENTALIS, LEDUM PALUSTRE LIQUID ORAL 20160901 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; ATROPA BELLADONNA; THUJA OCCIDENTALIS LEAFY TWIG; LEDUM PALUSTRE TWIG 8; 8; 8; 8; 8; 8 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 60512-9202_4be6c2b9-a915-46c5-8f47-7f050dcf83de 60512-9202 HUMAN OTC DRUG Teething Kids Relief Baby CHAMOMILLA, ARNICA MONTANA, BORAX, HYPERICUM PERFORATUM LIQUID ORAL 20160901 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC MATRICARIA RECUTITA; ARNICA MONTANA; SODIUM BORATE; HYPERICUM PERFORATUM 5; 5; 5; 5 [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL N 20181231 60512-9204_567f4c26-a46b-4bec-9233-afe058d53fce 60512-9204 HUMAN OTC DRUG KIDS RELIEF CALENDULA CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHYTOLACCA DECANDRA, CANTHARIS, SULPHUR CREAM TOPICAL 20161107 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; PHYTOLACCA AMERICANA ROOT; LYTTA VESICATORIA; SULFUR 1; 1; 3; 3; 3; 3 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g N 20181231 60512-9210_9230e253-6fb4-420d-ad6f-e2a8e5dda318 60512-9210 HUMAN OTC DRUG KIDS RELIEF COUGH AND COLD DROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM SYRUP ORAL 20161101 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA ROOT; IPECAC; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; TIN 1; 3; 3; 3; 1; 3; 3; 3 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL N 20181231 60512-9212_41ed4f77-f525-4c90-9545-8b44e52d5e96 60512-9212 HUMAN OTC DRUG COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF DROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CHAMOMILLA, COFFEA CRUDA SYRUP ORAL 20161101 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC DROSERA ROTUNDIFOLIA FLOWERING TOP; ARNICA MONTANA; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; TIN; MATRICARIA RECUTITA; ARABICA COFFEE BEAN 1; 3; 3; 1; 3; 3; 3; 4; 4 [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL N 20181231 60512-9214_169b1163-f23b-4ef0-98ca-0819a2bb600b 60512-9214 HUMAN OTC DRUG KIDS RELIEF EAR RELIEF FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, PYROGENIUM, ARSENICUM ALBUM LIQUID ORAL 20161026 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC FERRUM PHOSPHORICUM; CAPSICUM ANNUUM WHOLE; RANCID BEEF; ARSENIC TRIOXIDE 30; 30; 30; 30 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 60512-9216_a445c1c9-f9e9-482c-86a6-8257fdbfef87 60512-9216 HUMAN OTC DRUG KIDS RELIEF PAIN AND FEVER ARNICA MONTANA, FERRUM PHOSPHORICUM, HYPERICUM PERFORATUM, THUJA OCCIDENTALIS, LEDUM PALUSTRE LIQUID ORAL 20161021 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC ARNICA MONTANA; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; THUJA OCCIDENTALIS LEAFY TWIG; LEDUM PALUSTRE TWIG 8; 8; 8; 8; 8 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 60512-9300_2c3d7039-62d7-485c-a13a-e6d21fb6e85a 60512-9300 HUMAN OTC DRUG ECHINACEA SUPPORT ECHINACEA PURPUREA, ZINCUM METALLICUM PELLET ORAL 20131018 UNAPPROVED HOMEOPATHIC HOMEOLAB USA INC. ECHINACEA PURPUREA; ECHINACEA PURPUREA ROOT; ZINC 6; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 60533-001_ee4afd68-ffe9-479a-a9e4-71b6407bd70b 60533-001 HUMAN OTC DRUG Candy Coated Apple anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL E 20171231 60533-002_97046468-b381-41c0-a77c-c5e1c9750eed 60533-002 HUMAN OTC DRUG Cool Clementine anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL E 20171231 60533-003_39e9e628-b808-4dab-bb53-3ca7846ccbae 60533-003 HUMAN OTC DRUG Cotton candy anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL E 20171231 60533-004_92761365-4a59-4e5d-8c85-d91b14928406 60533-004 HUMAN OTC DRUG Frosted cranberry anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL E 20171231 60533-005_4c69c235-b624-417c-a01b-1a3ecc7352df 60533-005 HUMAN OTC DRUG Gingerhead Girl anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL E 20171231 60533-006_3767936f-17f4-4a60-98b2-1eaf6e8bac40 60533-006 HUMAN OTC DRUG Lemon splash anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL E 20171231 60533-007_7b4500b2-fd60-4b0d-9675-41ab6f257029 60533-007 HUMAN OTC DRUG Mango papaya anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL E 20171231 60533-008_d4081072-8662-4a28-8222-d53361b06f43 60533-008 HUMAN OTC DRUG Peppermint Ice anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL E 20171231 60533-009_a3c902f6-d530-4431-92d8-6a2c9950f893 60533-009 HUMAN OTC DRUG Pumpkin pie anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL E 20171231 60533-010_79791b84-7ad8-4442-a449-1d82c4c255d5 60533-010 HUMAN OTC DRUG Sweet pea anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL E 20171231 60533-011_884077e5-6694-424e-bf3c-0ae2ecd035ac 60533-011 HUMAN OTC DRUG Vanilla cupcake anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL E 20171231 60533-012_cc972c0e-d5f0-42bf-8c5e-911b1bc55187 60533-012 HUMAN OTC DRUG Vanilla sugar anti-bacterial SCENTED HAND SANITIZER Alcohol SOLUTION TOPICAL 20130813 OTC MONOGRAPH NOT FINAL part333E Best Accessory Group ALCOHOL 62 mL/100mL E 20171231 60539-001_43d5c2f2-53f3-446a-81c9-a89d1b5ba98d 60539-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130531 UNAPPROVED MEDICAL GAS Respacare of Louisiana OXYGEN 99 L/100L E 20171231 60541-0706_4ea06c16-dd36-40a8-950d-7f9484bec0cd 60541-0706 HUMAN OTC DRUG Moisturizing Tint SPF 30 Octinoxate, Octisalate, Oxybenzone, Avobenzone LOTION TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Hayden Caleel LLC OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 7.5; 5; 4; 3 g/mL; g/mL; g/mL; g/mL N 20181231 60541-1000_609f2b35-15f4-b5fc-e053-2a91aa0aca6e 60541-1000 HUMAN OTC DRUG glo SKIN BEAUTY Oil Free SPF 40 glo SKIN BEAUTY Oil Free SPF 40 LOTION TOPICAL 20171231 OTC MONOGRAPH FINAL part352 Hayden Caleel LLC OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 2.5; 7.5 g/100g; g/100g; g/100g N 20181231 60541-1100_60b21f49-c4d5-ca12-e053-2991aa0aaf66 60541-1100 HUMAN OTC DRUG glo SKIN BEAUTY Moisturizing Tint SPF 30 glo SKIN BEAUTY Moisturizing Tint SPF 30 LOTION TOPICAL 20171231 OTC MONOGRAPH FINAL part352 Hayden Caleel LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 4 g/g; g/g; g/g; g/g N 20181231 60541-1200_60b2ba1f-d826-1b74-e053-2a91aa0ab0ee 60541-1200 HUMAN OTC DRUG glo SKIN BEAUTY Solar Shade SPF 50 glo SKIN BEAUTY Solar Shade SPF 50 LOTION TOPICAL 20171231 OTC MONOGRAPH FINAL part352 Hayden Caleel LLC TITANIUM DIOXIDE; ZINC OXIDE 6.5; 8.6 g/g; g/g N 20181231 60541-1300_60de4400-ae34-f742-e053-2991aa0aa726 60541-1300 HUMAN OTC DRUG glo SKIN BEAUTY Luxe Liquid Foundation SPF 18 glo SKIN BEAUTY Luxe Liquid Foundation SPF 18 CREAM TOPICAL 20171231 OTC MONOGRAPH FINAL part352 Hayden Caleel LLC TITANIUM DIOXIDE; OCTINOXATE 10; 5 g/g; g/g N 20181231 60541-1400_60ded7af-5533-227a-e053-2a91aa0addb5 60541-1400 HUMAN OTC DRUG glo SKIN BEAUTY Tinted Primer SPF 30 glo SKIN BEAUTY Tinted Primer SPF 30 CREAM TOPICAL 20171231 OTC MONOGRAPH FINAL part352 Hayden Caleel LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 4 g/g; g/g N 20181231 60541-1500_6152acdc-14ff-1851-e053-2a91aa0a86e2 60541-1500 HUMAN OTC DRUG glo SKIN BEAUTY Balm Mint SPF 15 glo SKIN BEAUTY Balm Mint SPF 15 STICK TOPICAL 20171231 OTC MONOGRAPH FINAL part352 Hayden Caleel LLC OCTINOXATE; OXYBENZONE 7.5; 3 g/g; g/g N 20181231 60541-1600_6152acdc-1508-1851-e053-2a91aa0a86e2 60541-1600 HUMAN OTC DRUG glo SKIN BEAUTY Cherry Mint SPF 15 glo SKIN BEAUTY Cherry Mint SPF 15 STICK TOPICAL 20171231 OTC MONOGRAPH FINAL part352 Hayden Caleel LLC OCTINOXATE; OXYBENZONE 7.5; 3 g/g; g/g N 20181231 60541-1700_6166d180-6df0-1533-e053-2991aa0a2082 60541-1700 HUMAN OTC DRUG glo SKIN BEAUTY Clear Skin Cleanser glo SKIN BEAUTY Clear Skin Cleanser LIQUID TOPICAL 20171130 OTC MONOGRAPH FINAL part333D Hayden Caleel LLC SALICYLIC ACID 2 g/100g N 20181231 60541-1800_61676c71-b1eb-266c-e053-2991aa0aa1a3 60541-1800 HUMAN OTC DRUG glo SKIN BEAUTY Clear Skin Spot Treatment glo SKIN BEAUTY Clear Skin Spot Treatment LIQUID TOPICAL 20171130 OTC MONOGRAPH FINAL part333D Hayden Caleel LLC BENZOYL PEROXIDE 5 g/100g N 20181231 60541-1900_6168b2f3-1988-24bb-e053-2991aa0a8ca3 60541-1900 HUMAN OTC DRUG glo SKIN BEAUTY Remedy Gel glo SKIN BEAUTY Remedy Gel GEL TOPICAL 20171231 OTC MONOGRAPH NOT FINAL part348 Hayden Caleel LLC HYDROCORTISONE 1 g/100g N 20181231 60541-8407_332c5fb6-263c-4b12-b37b-59a80c19c71e 60541-8407 HUMAN OTC DRUG Octinoxate Octinoxate LOTION TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Hayden Caleel LLC OCTINOXATE .05 g/mL N 20181231 60546-001_60c71a0a-7425-92e7-e053-2991aa0a8cc9 60546-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20170509 UNAPPROVED MEDICAL GAS At Home Medical OXYGEN 99 L/100L N 20181231 60549-1129_9dc5c5d2-0af3-4e56-9203-0b536c3cc134 60549-1129 HUMAN OTC DRUG Luxury Triclosan LIQUID TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part333A Tomco-Harwel Industries Inc TRICLOSAN 1.5 g/L E 20171231 60549-2108_d79e5a0e-03f2-4813-9153-bd8c040d0f88 60549-2108 HUMAN OTC DRUG Satin Pink Triclosan LIQUID TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part333A Tomco-Harwel Industries Inc TRICLOSAN 1.08 g/L E 20171231 60555-622_5dd309f5-5c0d-49d1-a6e0-0bba7eb4bbc0 60555-622 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS Ameri-Quipt of North Carolina, Inc OXYGEN 99 L/100L E 20171231 60560-1072_a81171ce-09ca-4b5d-9cb2-a66a8082d3ab 60560-1072 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20081111 UNAPPROVED MEDICAL GAS Johns Hopkins Pharmaquip OXYGEN 99 L/100L E 20171231 60561-0001_acb281a9-f20b-448c-9a56-13333c57c532 60561-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030203 UNAPPROVED MEDICAL GAS Richmond Respiratory & Medical Supply OXYGEN 99 L/100L E 20171231 60564-0001_fcbf1d78-6097-410e-a253-42ad81bd12c9 60564-0001 HUMAN OTC DRUG Liquid Serotonin Serotonin LIQUID ORAL 20140314 UNAPPROVED HOMEOPATHIC Pain and Stress Center Products SEROTONIN HYDROCHLORIDE 3 [hp_X]/mL N 20181231 60564-0002_102f78db-431b-4e9d-b454-2cde86b095b2 60564-0002 HUMAN OTC DRUG Neuro Links 5-METHOXYTRYPTAMINE, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), LIQUID ORAL 20141202 UNAPPROVED HOMEOPATHIC Pain & Stress Center Products 5-METHOXYTRYPTAMINE; ACETYLCHOLINE CHLORIDE; DOPAMINE HYDROCHLORIDE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE DIHYDROCHLORIDE; LEVODOPA; MELATONIN; NOREPINEPHRINE; PHENETHYLAMINE; SEROTONIN HYDROCHLORIDE; TAURINE; TYRAMINE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 60565-010_3eb26348-a207-4eb1-a182-feabf2695581 60565-010 HUMAN OTC DRUG Cellisys EX Wrinkle Solution Emulsion Dimethicone CREAM TOPICAL 20130701 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE 2.8 mg/140mL N 20181231 60565-011_37806c6c-1256-46da-e054-00144ff88e88 60565-011 HUMAN OTC DRUG Cellisys EX EGF Intense Mask EGF Glycerin LIQUID TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part347 DN Company Co., Ltd. GLYCERIN 10 g/100g N 20181231 60565-012_31a0c630-7a1f-6b2c-e054-00144ff8d46c 60565-012 HUMAN OTC DRUG Cellisys EX EGF Wrinkle 29 Activator Dimethicone CREAM TOPICAL 20130701 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE .5 g/100mL N 20181231 60565-013_320cb3f2-fc22-3552-e054-00144ff88e88 60565-013 HUMAN OTC DRUG Wrinkle Solution Concentrating Essence Special Set Dimethicone KIT 20160428 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. N 20181231 60565-014_31a15b72-8657-6465-e054-00144ff88e88 60565-014 HUMAN OTC DRUG Cellisys EX Wrinkle Solution Dimethicone CREAM TOPICAL 20130701 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE .3 g/100mL N 20181231 60565-015_3780a962-665e-6fa7-e054-00144ff8d46c 60565-015 HUMAN OTC DRUG Cellisys EX EGF Wrinkle 29 Activator glycerin CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part347 DN Company Co., Ltd. GLYCERIN; DIMETHICONE 6.068; .5 g/100mL; g/100mL N 20181231 60565-016_3781780c-3aa6-21b3-e054-00144ff8d46c 60565-016 HUMAN OTC DRUG Wrinkle Solution Concentrating Essence Special Set Dimethicone KIT 20160428 OTC MONOGRAPH NOT FINAL part347 DN Company Co., Ltd. N 20181231 60565-017_37806c6c-1279-46da-e054-00144ff88e88 60565-017 HUMAN OTC DRUG Cellisys EX Wrinkle Solution Dimethicone CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part347 DN Company Co., Ltd. GLYCERIN; DIMETHICONE 13.162475; .3 g/100mL; g/100mL N 20181231 60565-020_8c52b243-0a6e-469a-965a-3a81079adf27 60565-020 HUMAN OTC DRUG Cellisys EX Wrinkle Solution Eye Contour Dimethicone CREAM TOPICAL 20130701 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE .51 mg/15mL N 20181231 60565-030_cb04cb03-d0a7-4562-b351-ea1a98768ffb 60565-030 HUMAN OTC DRUG Easydew EX Renewal Moisture Dimethicone CREAM TOPICAL 20130701 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE .46 mg/40mL N 20181231 60565-040_a2d64d57-a8e6-45ca-adc0-384cf489dbc5 60565-040 HUMAN OTC DRUG Easydew EX Mineral BB SPF45 PA PLUS PLUS Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 DN Company Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.97; 2.8; 1.17 mg/40mL; mg/40mL; mg/40mL N 20181231 60565-050_68ac73c5-339f-4220-8ea4-1851f893a016 60565-050 HUMAN OTC DRUG Easydew EX Fresh Mild SunScreen SPF50 PLUS PA PLUS PLUS PLUS Octinoxate, Titanium Dioxide, Octisalate, Octocrylene CREAM TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 DN Company Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; OCTOCRYLENE 3; 1.7; .8; .8 mg/40mL; mg/40mL; mg/40mL; mg/40mL N 20181231 60565-060_e1f16373-f565-40ce-81c4-3aa37f16ffac 60565-060 HUMAN OTC DRUG Cellisys EX Wrinkle Solution Eye Contour EGF Dimethicone CREAM TOPICAL 20130701 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE .15 mg/15mL N 20181231 60565-070_162b2e03-e337-405a-a184-72f58aa5adec 60565-070 HUMAN OTC DRUG Easydew Daily Baby Care Sun Homosalate, OCTISALATE, Titanium Dioxide, AVOBENZONE, OCTINOXATE CREAM TOPICAL 20160715 OTC MONOGRAPH NOT FINAL part352 DN Company Co., Ltd. HOMOSALATE; OCTISALATE; TITANIUM DIOXIDE; AVOBENZONE; OCTINOXATE 6; 3; 2.2; 1.8; 1.8 g/60mL; g/60mL; g/60mL; g/60mL; g/60mL N 20181231 60565-080_78d9bee4-c572-45aa-aa3c-e30c3f40e9c2 60565-080 HUMAN OTC DRUG EASYDEW DAILY DOUBLE HYDRA Dimethicone CREAM TOPICAL 20160715 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE .9 g/60mL N 20181231 60565-090_741f209d-bb4b-43dd-a9a1-4dcd427831fd 60565-090 HUMAN OTC DRUG EASYDEW DAILY DOUBLE HYDRA ESSENCE Dimethicone CREAM TOPICAL 20160715 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE .4 g/40mL N 20181231 60565-100_6ee8eacc-3fc0-4c13-a8a3-9f6a8b6484a7 60565-100 HUMAN OTC DRUG EASYDEW DAILY DOUBLE HYDRA Toner Glycerin LIQUID TOPICAL 20160715 UNAPPROVED DRUG OTHER DN Company Co., Ltd. GLYCERIN 4.8 g/160mL N 20181231 60565-110_29c89d6d-ce07-4f63-b897-c6ef710496eb 60565-110 HUMAN OTC DRUG EASYDEW DAILY EXTRA MILD PEELING Glycerin GEL TOPICAL 20160715 UNAPPROVED DRUG OTHER DN Company Co., Ltd. GLYCERIN 14.4 g/120mL N 20181231 60565-120_854ccdea-c9fb-4d3f-85fd-1a08fd5465bb 60565-120 HUMAN OTC DRUG EASYDEW DAILY FINISH ALL IN ONE MOISTURE Dimethicone CREAM TOPICAL 20160715 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE .6 g/60mL N 20181231 60565-130_7465cd74-16e2-4ae2-a10d-f9f46e1d0e7e 60565-130 HUMAN OTC DRUG Easydew Daily Fresh Mild Sun OCTINOXATE, TITANIUM DIOXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20160715 OTC MONOGRAPH NOT FINAL part352 DN Company Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 4.5; 2.5; 1.5; 1.2; 1.2 g/60mL; g/60mL; g/60mL; g/60mL; g/60mL N 20181231 60565-140_df727f9f-c6e1-497c-8bcd-9c302c184c1c 60565-140 HUMAN OTC DRUG EASYDEW DAILY MOIST CLEANSING MILK Dimethicone EMULSION TOPICAL 20160715 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. DIMETHICONE 1.5 g/150mL N 20181231 60565-150_b6bd479d-8506-462a-9037-cb404551b7fe 60565-150 HUMAN OTC DRUG EASYDEW DAILY MOIST CLEANSING WHIP FOA M Glycerin GEL TOPICAL 20160715 OTC MONOGRAPH FINAL part347 DN Company Co., Ltd. GLYCERIN 24 g/120mL N 20181231 60565-160_affd3787-2862-4947-a45a-13a11c0110f5 60565-160 HUMAN OTC DRUG Easydew Daily Ultra Shield Sun Homosalate, AVOBENZONE, ENSULIZOLE CREAM TOPICAL 20160715 OTC MONOGRAPH NOT FINAL part352 DN Company Co.,Ltd. HOMOSALATE; AVOBENZONE; ENSULIZOLE 6; 2.1; 2.1 g/60mL; g/60mL; g/60mL N 20181231 60565-170_b230617f-ea70-4401-95ab-5fc2b0c801af 60565-170 HUMAN OTC DRUG Easydew Daily Water Proof Sun Zinc Oxide, Octinoxate, Titanium Dioxide, Octisalate, Octocrylene CREAM TOPICAL 20160715 OTC MONOGRAPH NOT FINAL part352 DN Company Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE; OCTISALATE; OCTINOXATE; OCTOCRYLENE 4.6; 2.7; 2.7; 4.2; 1.2 g/60mL; g/60mL; g/60mL; g/60mL; g/60mL N 20181231 60565-180_7b7e2293-4a2f-49f3-95d3-636c14deec21 60565-180 HUMAN OTC DRUG Easydew Daily DOUBLE HYDRA CREA M MASK Glycerin PATCH TOPICAL 20160715 UNAPPROVED DRUG OTHER DN Company Co., Ltd. GLYCERIN 1.3 g/25mL N 20181231 60565-190_644836e7-ebfc-4d58-be42-98d63181487e 60565-190 HUMAN OTC DRUG Easydew Daily 2 Step Derma Peel Mask Salicylic Acid PATCH TOPICAL 20160715 UNAPPROVED DRUG OTHER DN Company Co., Ltd. SALICYLIC ACID 3 mg/30mL N 20181231 60565-200_6a137ed0-e7ea-4489-8643-4f0dff5373bd 60565-200 HUMAN OTC DRUG Easydew Daily 2 Step Vita Toning Mask Allantoin PATCH TOPICAL 20160715 UNAPPROVED DRUG OTHER DN Company Co., Ltd. ALLANTOIN .1 g/49g N 20181231 60565-210_5fc6bc1b-8da5-4121-bbd7-60562f7e4efd 60565-210 HUMAN OTC DRUG EASYDEW DAILY BABY SMOOTHING SUN Titanium Dioxide LOTION TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 DN Company Co., Ltd. TITANIUM DIOXIDE 2.14 g/60mL N 20181231 60565-220_af3324e3-c4e7-4504-b2bf-e393f3da8e6c 60565-220 HUMAN OTC DRUG Easydew Daily Fresh Mild Sun SPF50 Plus Homosalate, Octisalate, Titanium Dioxide, Avobenzone CREAM TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 DN Company Co.,Ltd. HOMOSALATE; OCTISALATE; TITANIUM DIOXIDE; AVOBENZONE 6; 3; 2.29; 1.8 g/60mL; g/60mL; g/60mL; g/60mL N 20181231 60568-001_b9a26361-6031-4ad7-af92-85142c52b191 60568-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130717 UNAPPROVED MEDICAL GAS Mountain West Medical Supply OXYGEN 99 L/100L E 20171231 60574-4113_11f03a0f-c7c8-4eb5-945e-61e7da9784c6 60574-4113 HUMAN PRESCRIPTION DRUG Synagis palivizumab INJECTION, SOLUTION INTRAMUSCULAR 19980619 BLA BLA103770 MedImmune, LLC PALIVIZUMAB 100 mg/mL Antibodies, Monoclonal [Chemical/Ingredient],Fusion Protein Inhibitors [MoA],Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC] N 20181231 60574-4114_11f03a0f-c7c8-4eb5-945e-61e7da9784c6 60574-4114 HUMAN PRESCRIPTION DRUG Synagis palivizumab INJECTION, SOLUTION INTRAMUSCULAR 19991209 BLA BLA103770 MedImmune, LLC PALIVIZUMAB 50 mg/.5mL Antibodies, Monoclonal [Chemical/Ingredient],Fusion Protein Inhibitors [MoA],Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC] N 20181231 60575-212_62ec8ee2-4187-48d6-861b-1e586b529912 60575-212 HUMAN OTC DRUG Codar AR Chlorpheniramine Maleate, Codeine Phosphate LIQUID ORAL 20110620 OTC MONOGRAPH FINAL part341 Respa Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE 2; 8 mg/5mL; mg/5mL CV E 20171231 60575-313_cfbbbfc0-ceb1-42b7-927b-6dcc58e30f1f 60575-313 HUMAN OTC DRUG Tricode AR Chlorpheniramine Maleate, Codeine Phosphate, Pseudoephedrine Hydrochloride LIQUID ORAL 20110620 OTC MONOGRAPH FINAL part341 Respa Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 8; 30 mg/5mL; mg/5mL; mg/5mL CV E 20171231 60575-414_ba3af78f-2f38-48c7-94bf-36416da895a5 60575-414 HUMAN OTC DRUG Tricode GF Codeine Phosphate, Guaifenesin, Pseudoephedrine Hydrochloride LIQUID ORAL 20110620 OTC MONOGRAPH FINAL part341 Respa Pharmaceuticals, Inc. CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 8; 200; 30 mg/5mL; mg/5mL; mg/5mL CV E 20171231 60575-515_076f7810-5c2b-4d9b-9a69-4308cb9440ca 60575-515 HUMAN OTC DRUG CODAR D Codeine Phosphate, Pseudoephedrine Hydrochloride LIQUID ORAL 20110713 OTC MONOGRAPH FINAL part341 Respa Pharmaceuticals CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE 8; 30 mg/5mL; mg/5mL CV E 20171231 60575-616_1e3023d2-63bb-4367-9152-84ed9adcd90f 60575-616 HUMAN OTC DRUG Codar GF Codeine Phosphate, Guaifenesin LIQUID ORAL 20110621 OTC MONOGRAPH FINAL part341 Respa Pharmaceuticals, Inc. CODEINE PHOSPHATE; GUAIFENESIN 8; 200 mg/5mL; mg/5mL CV E 20171231 60577-574_f674cf9f-e630-47e9-8e87-5afeb8e1c24b 60577-574 HUMAN OTC DRUG Childrens Nanomol Dye-Free Cherry Acteaminophen SUSPENSION ORAL 20160817 OTC MONOGRAPH NOT FINAL part343 Vitane Pharmaceutical Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 60577-974_b27ffc07-347b-4ad0-8322-3f74d31a5e86 60577-974 HUMAN OTC DRUG Infants Nanomol Dye-Free Cherry Acteaminophen SUSPENSION ORAL 20160606 OTC MONOGRAPH NOT FINAL part343 Vitane Pharmaceutical Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 60589-001_09d74dce-91c6-4283-abcb-839e27431007 60589-001 HUMAN OTC DRUG SmartRx Natural Pain Relief Sleeve ANKLE METHYL SALICYLATE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part348 Niche Brands, Inc. METHYL SALICYLATE 10 g/100g E 20171231 60589-002_807aee49-a168-4baa-b565-2c85f76c90d4 60589-002 HUMAN OTC DRUG SmartRx Natural Pain Relief Sleeve BACK METHYL SALICYLATE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part348 Niche Brands, Inc. METHYL SALICYLATE 10 g/100g E 20171231 60589-003_abb54a95-64a3-4f97-8f8f-7319e206285d 60589-003 HUMAN OTC DRUG SmartRx Natural Pain Relief Sleeve ELBOW METHYL SALICYLATE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part348 Niche Brands, Inc. METHYL SALICYLATE 10 g/100g E 20171231 60589-004_7068ec27-1354-40e3-8a84-fb7efcd72788 60589-004 HUMAN OTC DRUG SmartRx Natural Pain Relief Sleeve KNEE METHYL SALICYLATE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part348 Niche Brands, Inc. METHYL SALICYLATE 10 g/100g E 20171231 60589-005_2313847e-133f-48ca-9d87-06a6d390a99a 60589-005 HUMAN OTC DRUG SmartRx Natural Pain Relief Sleeve WRIST METHYL SALICYLATE LIQUID TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part348 Niche Brands, Inc. METHYL SALICYLATE 10 g/100g E 20171231 60596-1072_908c6a59-8e2a-4ba3-bf40-28b4b0b3018d 60596-1072 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060403 UNAPPROVED MEDICAL GAS Banner Home Medical Equipment OXYGEN 99 L/100L E 20171231 60599-999_6bf44095-4ff0-4ed2-b7be-4e7d48f92131 60599-999 HUMAN OTC DRUG Assured Aloe Ethyl Alcohol GEL TOPICAL 20171027 OTC MONOGRAPH NOT FINAL part333E 4E Global, S.A.P.I. de C.V ALCOHOL 70 mL/100mL N 20191231 60605-0001_19ed795c-274b-46a9-81c0-30af10e03711 60605-0001 HUMAN OTC DRUG SANG LEAF GINSENG COLLAGEN ALLANTOIN SOAP TOPICAL 20150913 OTC MONOGRAPH FINAL part347 Hanil Moolsan Co. ALLANTOIN .05 g/100g E 20171231 60608-011_206bc7b7-5a2a-4e00-9dc2-3ca2c7b681c2 60608-011 HUMAN OTC DRUG Bio-Scriptives Lidum Lidocaine CREAM TOPICAL 20100723 OTC MONOGRAPH NOT FINAL part348 BioChemics, Inc LIDOCAINE HYDROCHLORIDE 2.8 g/56g E 20171231 60608-012_9f2c0a7d-ef5f-4ae4-bf9b-b8558a293e9e 60608-012 HUMAN OTC DRUG Bio-Scriptives Repiderm Benzoly Peroxide CREAM TOPICAL 20100724 OTC MONOGRAPH FINAL part333D BioChemics, Inc. BENZOYL PEROXIDE 3.29 g/56g E 20171231 60608-013_21203d45-e7b4-4bb2-a475-f8711a6ba65d 60608-013 HUMAN OTC DRUG Bio-Scriptives Extreme AF Tolnaftate CREAM TOPICAL 20110727 OTC MONOGRAPH FINAL part333C BioChemics, Inc. TOLNAFTATE .56 g/56.69g E 20171231 60608-015_340499f2-470d-45f9-8893-0eea055d7a6a 60608-015 HUMAN OTC DRUG Bio-Scriptives Extreme PR Menthol LOTION TOPICAL 20110215 OTC MONOGRAPH NOT FINAL part348 BioChemics, Inc. MENTHOL 5.11 g/113g E 20171231 60608-016_25174fb2-87a8-4a29-96f8-e0fd452b5971 60608-016 HUMAN OTC DRUG Bio-Scriptives Lidum Hemorroidal (Anorectal) Lidocaine CREAM TOPICAL 20120304 OTC MONOGRAPH FINAL part346 Bio-Scriptives, Inc. LIDOCAINE 2.8 g/56g E 20171231 60608-017_fa228065-45fa-40fe-8057-18c69a1b8394 60608-017 HUMAN PRESCRIPTION DRUG Bio-Scriptives Lidum Topical Analgesic Lidocaine CREAM TOPICAL 20120307 OTC MONOGRAPH FINAL part346 Bio-Scriptives, Inc. LIDOCAINE 2.8 g/56g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 60611-0001_4a572731-0120-11d4-e054-00144ff8d46c 60611-0001 HUMAN OTC DRUG CAVIALL PERFECT REPAIR SERUM Adenosine GEL TOPICAL 20170310 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. ADENOSINE .04 g/100mL N 20181231 60611-0002_4a578440-19ba-21d5-e054-00144ff8d46c 60611-0002 HUMAN OTC DRUG CAVIALLCRYSTAL Adenosine CREAM TOPICAL 20170216 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. ADENOSINE .04 g/100g N 20181231 60611-0003_4926f00c-ee2a-3e10-e054-00144ff88e88 60611-0003 HUMAN OTC DRUG CAVIALL Wrinkle-Free PowerTox Niacinamide LIQUID TOPICAL 20170216 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE .3 g/100mL N 20181231 60611-0004_492c265e-1adc-599e-e054-00144ff8d46c 60611-0004 HUMAN OTC DRUG CAVIALL REAL CAVIAR MULTI-PERFECTION O2 SERUM Niacinamide, Adenosine GEL TOPICAL 20170216 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 60611-0006_4a58190e-39d8-38bb-e054-00144ff8d46c 60611-0006 HUMAN OTC DRUG ABALONE CRYSTALDOUBLE EX AMPOULE Arbutin, Adenosine LIQUID TOPICAL 20170310 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. ARBUTIN; ADENOSINE 2.2; .044 g/100mL; g/100mL N 20181231 60611-0007_492c9079-99b6-09bf-e054-00144ff88e88 60611-0007 HUMAN OTC DRUG ABALONE CrystalDouble EX Niacinamide, Adenosine CREAM TOPICAL 20170216 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 60611-0008_4a586784-c0b5-4a3c-e054-00144ff8d46c 60611-0008 HUMAN OTC DRUG ABALONE CRYSTALDOUBLE EX CC Niacinamide, Adenosine, Titanium Dioxide, Ethylhexyl Methoxycinnamate CREAM TOPICAL 20170310 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE; TITANIUM DIOXIDE; ADENOSINE; OCTINOXATE 2; 4.694; .04; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 60611-0009_4a58c83a-64d0-5d3a-e054-00144ff8d46c 60611-0009 HUMAN OTC DRUG ABALONE CRYSTALDOUBLE EX BB Octocrylene, Niacinamide, Adenosine, Titanium Dioxide, Ethylhexyl Methoxycinnamate CREAM TOPICAL 20170310 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. OCTOCRYLENE; NIACINAMIDE; TITANIUM DIOXIDE; ADENOSINE; OCTINOXATE 3; 2; 9.9; .04; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 60611-0010_493d61eb-2abc-318c-e054-00144ff88e88 60611-0010 HUMAN OTC DRUG ABALONE CRYSTALDOUBLE EX HOMME Niacinamide, Adenosine CREAM TOPICAL 20170220 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 60611-0011_48ec99f4-13ff-3622-e054-00144ff8d46c 60611-0011 HUMAN OTC DRUG ABALONE AQUA FLOOD WATER Niacinamide, Adenosine CREAM TOPICAL 20170216 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 60611-0012_48edd3d2-2867-73bb-e054-00144ff8d46c 60611-0012 HUMAN OTC DRUG MIESOO PERFECT PURE SEED TONER Niacinamide, Adenosine LIQUID TOPICAL 20170220 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 60611-0013_48edd3d2-287a-73bb-e054-00144ff8d46c 60611-0013 HUMAN OTC DRUG MIESOO PERFECT PURE SEED Niacinamide, Adenosine EMULSION TOPICAL 20170220 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 60611-0013_4916942c-8b86-59c4-e054-00144ff88e88 60611-0013 HUMAN OTC DRUG MIESOO PERFECT PURE SEED Niacinamide, Adenosine EMULSION TOPICAL 20170220 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 60611-0014_48edd3d2-2894-73bb-e054-00144ff8d46c 60611-0014 HUMAN OTC DRUG MIESOO PERFECT PURE SEED ESSENCE Niacinamide, Adenosine GEL TOPICAL 20170220 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 60611-0015_48ef499c-d60c-4d67-e054-00144ff8d46c 60611-0015 HUMAN OTC DRUG MIESOO PERFECT PURE SEED Niacinamide, Adenosine CREAM TOPICAL 20170220 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 60611-0016_48ef499c-d61d-4d67-e054-00144ff8d46c 60611-0016 HUMAN OTC DRUG MIESOO PERFECT PURE SEED CYCLING AMPOULE Niacinamide, Adenosine GEL TOPICAL 20170220 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 60611-0017_492c9079-99c6-09bf-e054-00144ff88e88 60611-0017 HUMAN OTC DRUG ABALONE CrystalDouble EX SERUM Niacinamide, Adenosine GEL TOPICAL 20170216 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 60611-0018_5fa3dbab-ce93-df5a-e053-2a91aa0acb87 60611-0018 HUMAN OTC DRUG ABALONE HOMME FACE Niacinamide, Adenosine LOTION TOPICAL 20171205 UNAPPROVED DRUG OTHER C&BCOSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 60614-1001_4d67cc93-2c3d-4a4b-bfbc-48a572d6b37d 60614-1001 HUMAN OTC DRUG The21 DAYs HAIR NUTRIENT SERUM Glycerin LIQUID TOPICAL 20131219 OTC MONOGRAPH FINAL part347 GDKCOSMETICS Co., Ltd GLYCERIN .02 g/mL E 20171231 60615-0001_dd248fc1-605c-4703-ac0e-0d56caa778af 60615-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010109 UNAPPROVED MEDICAL GAS Advacare Medical Services, Inc. dba Petersen Medical OXYGEN 99 L/100L E 20171231 60621-033_dc890dd5-ab65-4d2f-816d-ecd23ea77734 60621-033 HUMAN PRESCRIPTION DRUG Theophylline Theophylline Anhydrous SOLUTION ORAL 20141103 ANDA ANDA091586 Cranbury Pharmaceuticals Inc THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 60630-077_3a3468b4-0626-71cd-e054-00144ff8d46c 60630-077 HUMAN OTC DRUG DenTek Instant Pain Relief Maximum Strength Benzocaine LIQUID DENTAL; TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part356 DenTek Oral Care, Inc. BENZOCAINE 200 mg/mL E 20171231 60630-077_dd0ab94d-0460-4069-bb82-cc2f6ed32a99 60630-077 HUMAN OTC DRUG DenTek Instant Pain Relief Maximum Strength Benzocaine LIQUID TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part356 DenTek Oral Care. Inc. BENZOCAINE 200 mg/mL E 20171231 60630-091_26919045-087a-0efd-e054-00144ff8d46c 60630-091 HUMAN OTC DRUG DenTek Canker Cover Menthol PATCH, EXTENDED RELEASE TRANSMUCOSAL 20151111 OTC MONOGRAPH NOT FINAL part356 DenTek Oral Care, Inc. MENTHOL 2.5 mg/194.85mg N 20181231 60630-091_26921ec2-016d-331e-e054-00144ff88e88 60630-091 HUMAN OTC DRUG DenTek Canker Cover Menthol PATCH, EXTENDED RELEASE TRANSMUCOSAL 20151111 OTC MONOGRAPH NOT FINAL part356 DenTek Oral Care, Inc. MENTHOL 2.5 mg/194.85mg N 20181231 60630-498_2b437c41-f6db-1da3-e054-00144ff88e88 60630-498 HUMAN OTC DRUG DenTek Looney Tunes Kids Bubblegum Blast Fluoride Toothpaste PASTE, DENTIFRICE DENTAL 20140228 OTC MONOGRAPH FINAL part355 DenTek Oral Care, Inc. SODIUM FLUORIDE .09639 g/76.5g E 20171231 60630-566_27f82004-adec-1112-e054-00144ff8d46c 60630-566 HUMAN OTC DRUG DenTek Eugenol Eugenol LIQUID DENTAL 20150701 OTC MONOGRAPH NOT FINAL part356 DenTek Oral Care, Inc. EUGENOL 850 mg/mL N 20181231 60630-608_25eb9c24-1fa8-100f-e054-00144ff88e88 60630-608 HUMAN OTC DRUG Walgreens Natural Eugenol/Toothache Medication with cotton pellets and tweezers Eugenol LIQUID DENTAL 20150701 OTC MONOGRAPH NOT FINAL part356 DenTek Oral Care, Inc. EUGENOL 850 mg/mL E 20171231 60631-040_af5f9f6c-636e-486c-982d-fc100dfe28e0 60631-040 HUMAN PRESCRIPTION DRUG Edarbi Azilsartan kamedoxomil TABLET ORAL 20130201 NDA NDA200796 Arbor Pharmaceuticals AZILSARTAN KAMEDOXOMIL 40 mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE] N 20191231 60631-080_af5f9f6c-636e-486c-982d-fc100dfe28e0 60631-080 HUMAN PRESCRIPTION DRUG Edarbi Azilsartan kamedoxomil TABLET ORAL 20130201 NDA NDA200796 Arbor Pharmaceuticals AZILSARTAN KAMEDOXOMIL 80 mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE] N 20191231 60631-412_04d4ae5d-27d1-43e6-876b-0037e6f174c0 60631-412 HUMAN PRESCRIPTION DRUG Edarbyclor Azilsartan kamedoxomil and chlorthalidone TABLET ORAL 20130201 NDA NDA202331 Arbor Pharmaceuticals AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE 40; 12.5 mg/1; mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20191231 60631-425_04d4ae5d-27d1-43e6-876b-0037e6f174c0 60631-425 HUMAN PRESCRIPTION DRUG Edarbyclor Azilsartan kamedoxomil and chlorthalidone TABLET ORAL 20130201 NDA NDA202331 Arbor Pharmaceuticals AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE 40; 25 mg/1; mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20191231 60635-118_636003c5-8a21-4380-909c-36f00c05fd88 60635-118 HUMAN PRESCRIPTION DRUG Varithena polidocanol KIT 20140710 NDA NDA205098 Biocompatibles, Inc. N 20181231 60635-123_636003c5-8a21-4380-909c-36f00c05fd88 60635-123 HUMAN PRESCRIPTION DRUG Varithena TM polidocanol KIT 20140710 NDA NDA205098 Biocompatibles, Inc. E 20171231 60635-133_636003c5-8a21-4380-909c-36f00c05fd88 60635-133 HUMAN PRESCRIPTION DRUG Varithena polidocanol KIT 20131125 NDA NDA205098 Biocompatibles, Inc. N 20181231 60637-001_7c92404c-49be-411c-a5c4-6e2e893c2744 60637-001 HUMAN OTC DRUG Justice ANTI BAC HAND SANITIZER Alcohol LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-002_021bcecd-d3dd-4176-9994-988f6b3def1f 60637-002 HUMAN OTC DRUG Justice ANTI BAC HAND SANITIZER Alcohol LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-003_4fe453c9-c116-410a-9d12-dfff125e534c 60637-003 HUMAN OTC DRUG Justice ANTI BAC HAND SANITIZER Alcohol LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-004_5bd0d479-0609-4af0-8e8c-5db442e90097 60637-004 HUMAN OTC DRUG Justice ANTI BAC HAND SANITIZER Alcohol LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-005_bc36cf45-2031-4bab-8906-1fcbba702e6f 60637-005 HUMAN OTC DRUG Justice ANTI BAC HAND SANITIZER Alcohol LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-006_715b4ea9-8e63-4ed5-9532-245c68077309 60637-006 HUMAN OTC DRUG Justice Vanilla ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140516 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-007_8c51f761-78fa-4024-b6fb-a362f6206c19 60637-007 HUMAN OTC DRUG Justice Mixed Berry ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140516 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-008_86c7c6ab-74ee-4ef2-bd1d-81bab386a537 60637-008 HUMAN OTC DRUG Justice Strawberry Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140516 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-009_a4716cdd-a5bb-4531-9ac0-9c592ac06643 60637-009 HUMAN OTC DRUG Justice Grape Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140516 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-010_182d0d94-63b3-41fd-b78a-fd0cf1886a60 60637-010 HUMAN OTC DRUG Justice Strawberry Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140516 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-011_6cc00eb3-70f0-4351-a4ee-4321317fc1e6 60637-011 HUMAN OTC DRUG Justice Vanilla Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140516 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-012_c275cce3-a2eb-428b-a12f-12afdb62ca21 60637-012 HUMAN OTC DRUG Justice Mixed berry Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-013_0f729c5c-a53b-4a0b-b8f1-8176981dbd65 60637-013 HUMAN OTC DRUG Justice Mixed berry Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-014_c4182690-26e8-4925-9984-e59ec07efe32 60637-014 HUMAN OTC DRUG Justice Vanilla Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-015_f86e6489-7079-49bc-9275-47179d733919 60637-015 HUMAN OTC DRUG Justice Blue berry Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-016_03ebb4d0-15ca-4e46-ae0a-37ce30448269 60637-016 HUMAN OTC DRUG Justice Cotton Candy Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-017_52a1dc8c-f477-4847-a78d-116abb691731 60637-017 HUMAN OTC DRUG Justice Fruit Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-018_a81a9999-25bd-4a30-9e67-ec7563f78338 60637-018 HUMAN OTC DRUG Justice Vanilla Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-019_506d6b7a-0c5e-455f-8a42-618d09dfb498 60637-019 HUMAN OTC DRUG Justice Grape Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-020_e6099e9c-539a-4fe1-988e-c7811f0c0780 60637-020 HUMAN OTC DRUG Justice Cotton Candy Scent ANTI BAC HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20141113 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-021_2de4da01-f1ec-4b77-9b25-abadb1c09046 60637-021 HUMAN OTC DRUG Justice Vanilla Scent Anti-bacterial Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20150127 OTC MONOGRAPH NOT FINAL part333A Tween Brands Inc ALCOHOL 62 g/100mL N 20181231 60637-022_6777e80c-b9bb-421b-abb4-06b17f6ff0da 60637-022 HUMAN OTC DRUG Justice Strawberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part333E Tween Brands Inc. ALCOHOL 620 mg/mL N 20181231 60637-030_064043fa-3f49-4c00-a95d-92fca6b2e815 60637-030 HUMAN OTC DRUG Justice Vanilla Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150818 OTC MONOGRAPH NOT FINAL part333E Tween Brands Inc ALCOHOL 620 mg/mL N 20181231 60637-031_61f4a471-0ab7-8791-e053-2991aa0ad7a0 60637-031 HUMAN OTC DRUG Justice Mixed Berry Scent Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150818 OTC MONOGRAPH NOT FINAL part333E Tween Brands Inc ALCOHOL 620 mg/mL N 20191231 60637-032_36086c94-4c5a-57f5-e054-00144ff8d46c 60637-032 HUMAN OTC DRUG Justice Bubble Gum Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150818 OTC MONOGRAPH NOT FINAL part333E Tween Brands Inc ALCOHOL 620 mg/mL N 20181231 60637-033_211e560c-1606-1403-e054-00144ff8d46c 60637-033 HUMAN OTC DRUG Justice Letter A Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150929 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-034_211e560c-1617-1403-e054-00144ff8d46c 60637-034 HUMAN OTC DRUG Justice Letter B Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-035_211e560c-1628-1403-e054-00144ff8d46c 60637-035 HUMAN OTC DRUG Justice Letter C Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-036_211e560c-1639-1403-e054-00144ff8d46c 60637-036 HUMAN OTC DRUG Justice Letter D Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-037_211e560c-164a-1403-e054-00144ff8d46c 60637-037 HUMAN OTC DRUG Justice Letter E Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-038_211e560c-165b-1403-e054-00144ff8d46c 60637-038 HUMAN OTC DRUG Justice Letter G Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-039_211fa436-8cc0-167c-e054-00144ff88e88 60637-039 HUMAN OTC DRUG Justice Letter H Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-040_211e560c-166c-1403-e054-00144ff8d46c 60637-040 HUMAN OTC DRUG Justice Letter I Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150929 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-041_211e560c-167d-1403-e054-00144ff8d46c 60637-041 HUMAN OTC DRUG Justice Letter J Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-042_211e560c-168e-1403-e054-00144ff8d46c 60637-042 HUMAN OTC DRUG Justice Letter K Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-043_211e560c-169f-1403-e054-00144ff8d46c 60637-043 HUMAN OTC DRUG Justice Letter L Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-044_211e560c-16b0-1403-e054-00144ff8d46c 60637-044 HUMAN OTC DRUG Justice Letter M Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-045_211fa436-8cd1-167c-e054-00144ff88e88 60637-045 HUMAN OTC DRUG Justice Letter N Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-046_211fc36c-ca55-4caa-e054-00144ff8d46c 60637-046 HUMAN OTC DRUG Justice Letter P Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-047_211fa436-8ce2-167c-e054-00144ff88e88 60637-047 HUMAN OTC DRUG Justice Letter R Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-048_211fa436-8cf3-167c-e054-00144ff88e88 60637-048 HUMAN OTC DRUG Justice Letter S Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-049_211fa436-8d04-167c-e054-00144ff88e88 60637-049 HUMAN OTC DRUG Justice Letter T Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-050_61f48e60-79c5-26fe-e053-2991aa0a2bce 60637-050 HUMAN OTC DRUG Justice Love Hugs Me and You Cotton Candy Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151020 OTC MONOGRAPH NOT FINAL part333E Tween Brands Inc ALCOHOL 620 mg/mL N 20191231 60637-051_61f48e60-79d5-26fe-e053-2991aa0a2bce 60637-051 HUMAN OTC DRUG Justice PUPPY LOVE Cotton Candy Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150528 OTC MONOGRAPH NOT FINAL part333E Tween Brands Inc ALCOHOL 620 mg/mL N 20191231 60637-052_25c8cf25-3040-1e42-e054-00144ff8d46c 60637-052 HUMAN OTC DRUG Justice Tortoise Green Apple Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151125 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-053_357b7a59-29b5-61e2-e054-00144ff88e88 60637-053 HUMAN OTC DRUG Justice Rhinestone Raspberry Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151130 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-054_25c8cf25-306a-1e42-e054-00144ff8d46c 60637-054 HUMAN OTC DRUG Justice Rabbit Strawberry Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151125 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-055_25c8a64c-2735-30e0-e054-00144ff88e88 60637-055 HUMAN OTC DRUG Justice Pop Corn Vanilla Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151125 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-056_25c8fabb-fccf-2d82-e054-00144ff8d46c 60637-056 HUMAN OTC DRUG Justice Latte Cotton Candy Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151125 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-057_25c8cf25-304e-1e42-e054-00144ff8d46c 60637-057 HUMAN OTC DRUG Justice Hamburger Green Apple Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151125 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-058_25c8b521-4bb6-31e3-e054-00144ff88e88 60637-058 HUMAN OTC DRUG Justice Dance Orange Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151125 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-059_61f4a471-0ad7-8791-e053-2991aa0ad7a0 60637-059 HUMAN OTC DRUG Justice Create Inspire Explore Blueberry Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151125 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20191231 60637-060_25c8cf25-3032-1e42-e054-00144ff8d46c 60637-060 HUMAN OTC DRUG Justice BFF Cotton Candy Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151125 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-061_268f5cee-3748-64c1-e054-00144ff8d46c 60637-061 HUMAN OTC DRUG Justice Cactus Vanilla Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-062_268f8f80-277f-197b-e054-00144ff8d46c 60637-062 HUMAN OTC DRUG Justice Elephant Mango Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-063_268fa5a8-5358-2766-e054-00144ff8d46c 60637-063 HUMAN OTC DRUG Justice Mermaid Mix Berry Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-064_268fa5a8-534a-2766-e054-00144ff8d46c 60637-064 HUMAN OTC DRUG Justice Pineapple Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-065_268fa5a8-5366-2766-e054-00144ff8d46c 60637-065 HUMAN OTC DRUG Justice Tucan Strawberry Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 620 mg/mL N 20181231 60637-066_2fd03dcf-787e-234a-e054-00144ff88e88 60637-066 HUMAN OTC DRUG Justice Berry Twist Scent Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160404 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-067_2fd03dcf-789a-234a-e054-00144ff88e88 60637-067 HUMAN OTC DRUG Justice Boho Berry Scent Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160404 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-068_2fd03dcf-78a8-234a-e054-00144ff88e88 60637-068 HUMAN OTC DRUG Justice Fruit Punch Scent Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160404 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-069_2fd03dcf-788c-234a-e054-00144ff88e88 60637-069 HUMAN OTC DRUG Justice Paris Punch Scent Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160404 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-070_2fd03dcf-7870-234a-e054-00144ff88e88 60637-070 HUMAN OTC DRUG Justice Sugar Swirl Scent Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160404 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-071_31028c97-9fdf-6635-e054-00144ff88e88 60637-071 HUMAN OTC DRUG Justice Beautiful Berry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160416 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-072_31025b38-6820-7173-e054-00144ff88e88 60637-072 HUMAN OTC DRUG Justice Shimmer Strawberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160416 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-073_31028c97-9fd1-6635-e054-00144ff88e88 60637-073 HUMAN OTC DRUG Justice Tribal Tangerine Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160416 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-074_61f4a471-0ae4-8791-e053-2991aa0ad7a0 60637-074 HUMAN OTC DRUG Justice Cool Candy Pink Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160427 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20191231 60637-075_318d04d2-d043-13e2-e054-00144ff88e88 60637-075 HUMAN OTC DRUG Justice Aztec Apple Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160428 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-076_318d3a82-658b-1cf4-e054-00144ff8d46c 60637-076 HUMAN OTC DRUG Justice Peace Love Lemonade Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160428 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-077_61f45ce4-b02b-2683-e053-2991aa0af8bc 60637-077 HUMAN OTC DRUG Justice Frosted Cupcake Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160428 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20191231 60637-078_3460ef52-93ba-2f0c-e054-00144ff8d46c 60637-078 HUMAN OTC DRUG Justice Be Strong Bright Citrus Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-079_3460ca00-2e4e-41c0-e054-00144ff88e88 60637-079 HUMAN OTC DRUG Justice Letter T Frosted Berry Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-080_3460ef52-93c8-2f0c-e054-00144ff8d46c 60637-080 HUMAN OTC DRUG Justice Dance Berry Blast Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-081_36707785-751e-362d-e054-00144ff8d46c 60637-081 HUMAN OTC DRUG Justice Sparkling Vanilla Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-082_61f45ce4-b038-2683-e053-2991aa0af8bc 60637-082 HUMAN OTC DRUG Justice Plum Berry Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20191231 60637-083_36707785-7581-362d-e054-00144ff8d46c 60637-083 HUMAN OTC DRUG Justice Peppermint Twist Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-084_3670a6d7-ee52-1e8d-e054-00144ff8d46c 60637-084 HUMAN OTC DRUG Justice Twist Peppermint Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-085_36707785-752c-362d-e054-00144ff8d46c 60637-085 HUMAN OTC DRUG Justice Sweet Cinnamon Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-086_36707785-7556-362d-e054-00144ff8d46c 60637-086 HUMAN OTC DRUG Justice Dazzling Berry Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-087_36707785-7565-362d-e054-00144ff8d46c 60637-087 HUMAN OTC DRUG Justice Strawberry Macaroon Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-088_61f45ce4-b045-2683-e053-2991aa0af8bc 60637-088 HUMAN OTC DRUG Justice Vanilla Latte Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20191231 60637-089_36707785-753a-362d-e054-00144ff8d46c 60637-089 HUMAN OTC DRUG Justice BFF go together like unicorns glitter Berry Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-090_36707785-759d-362d-e054-00144ff8d46c 60637-090 HUMAN OTC DRUG Justice Strawberry Stardust Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-091_36707785-7548-362d-e054-00144ff8d46c 60637-091 HUMAN OTC DRUG Justice Frosted Vanilla Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-092_38a435bb-4d7a-2ea6-e054-00144ff88e88 60637-092 HUMAN OTC DRUG Justice Bright Citrus Scent Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160727 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 62 mg/mL N 20181231 60637-109_a747220c-c1b3-45b5-af85-2effce74076c 60637-109 HUMAN OTC DRUG Justice Blueberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150527 OTC MONOGRAPH NOT FINAL part333E Tween Brands Inc ALCOHOL 620 mg/mL N 20181231 60637-110_342ca5e6-b50c-4da1-a3ef-783fe3b044ee 60637-110 HUMAN OTC DRUG Justice Vanilla Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150527 OTC MONOGRAPH NOT FINAL part333E Tween Brands Inc ALCOHOL 620 mg/mL N 20181231 60637-111_936147d7-425a-4ec9-9982-a9e7f8e98739 60637-111 HUMAN OTC DRUG Justice Cotton Candy Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150527 OTC MONOGRAPH NOT FINAL part333E Tween Brands Inc ALCOHOL 620 mg/mL N 20181231 60637-112_bc8ed0dd-8c50-4d72-8341-16851ccef1ff 60637-112 HUMAN OTC DRUG Justice Strawberry Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150528 OTC MONOGRAPH NOT FINAL part333E Tween Brands Inc ALCOHOL 620 mg/mL N 20181231 60637-113_1954cb0a-b488-4d59-b649-de52173b710a 60637-113 HUMAN OTC DRUG Justice Cotton Candy Scent Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150528 OTC MONOGRAPH NOT FINAL part333E Tween Brands Inc ALCOHOL 620 mg/mL N 20181231 60637-114_20bf2922-cfbe-4513-b071-1a107a42f016 60637-114 HUMAN OTC DRUG Justice Watermelon Scent Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20150528 OTC MONOGRAPH NOT FINAL part333E Tween Brands Inc ALCOHOL 620 mg/mL N 20181231 60637-115_3bdc32df-e41e-1c21-e054-00144ff88e88 60637-115 HUMAN OTC DRUG Sweet Berry Moisturizing Sunscreen Lip Balm SPF 15 Ethylhexyl Methoxycinnamate LIPSTICK TOPICAL 20160902 OTC MONOGRAPH NOT FINAL part352 Tween Brands Inc OCTINOXATE 122.5 mg/3.5g E 20171231 60637-116_3bdc32df-e42c-1c21-e054-00144ff88e88 60637-116 HUMAN OTC DRUG Fresh Mint Moisturizing Sunscreen Lip Balm SPF 15 Ethylhexyl Methoxycinnamate LIPSTICK TOPICAL 20160902 OTC MONOGRAPH NOT FINAL part352 Tween Brands Inc OCTINOXATE 122.5 mg/3.5g E 20171231 60637-200_43182c94-fa7b-5777-e054-00144ff8d46c 60637-200 HUMAN OTC DRUG Justice Strawberry Swirl Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20161207 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-201_43182c85-6d2c-5775-e054-00144ff8d46c 60637-201 HUMAN OTC DRUG Justice SPARKLING BERRY Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20161207 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-202_43182c85-6d3d-5775-e054-00144ff8d46c 60637-202 HUMAN OTC DRUG Justice Sugared DONUT Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20161207 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-203_43182c85-6d4d-5775-e054-00144ff8d46c 60637-203 HUMAN OTC DRUG Justice VANILLA Latte Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20161206 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-204_4317f7f9-542b-3952-e054-00144ff8d46c 60637-204 HUMAN OTC DRUG Justice Wild Melon Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20161207 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-205_4317f7f9-542d-3952-e054-00144ff8d46c 60637-205 HUMAN OTC DRUG Justice Electric LIME Bright Citrus Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20161207 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-206_4317e852-d534-2202-e054-00144ff8d46c 60637-206 HUMAN OTC DRUG Justice very BERRY Grape Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20161207 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-207_4317e852-d545-2202-e054-00144ff8d46c 60637-207 HUMAN OTC DRUG Justice Lavender DREAM Scented Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20161207 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-208_60ce5a78-1578-ae74-e053-2a91aa0ad116 60637-208 HUMAN OTC DRUG Justice BFF BERRY Scented Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 14.88 g/30mL N 20181231 60637-209_60ce6f0e-1dd8-54db-e053-2991aa0aabc6 60637-209 HUMAN OTC DRUG Justice WATERMELON Scented Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 14.88 g/30mL N 20181231 60637-210_60ce6601-a321-4c34-e053-2991aa0adaff 60637-210 HUMAN OTC DRUG Justice MAGICAL MELON Scented Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 14.88 g/30mL N 20181231 60637-211_60ce6601-a32a-4c34-e053-2991aa0adaff 60637-211 HUMAN OTC DRUG Justice Pinapple Pizazz Scented Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc. ALCOHOL 14.88 g/30mL N 20181231 60637-214_60ce70ce-6177-d512-e053-2a91aa0a6a8d 60637-214 HUMAN OTC DRUG Justice Rainbow Raspberry Scented Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170415 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-215_60ce6f0e-1de5-54db-e053-2991aa0aabc6 60637-215 HUMAN OTC DRUG Justice Outta This World Vanilla Scented Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170415 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-216_60ce79ce-ef6a-e941-e053-2a91aa0ad2a8 60637-216 HUMAN OTC DRUG Justice Berry Blast Scented Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170415 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-217_60ce836b-01cd-fae9-e053-2a91aa0abb7a 60637-217 HUMAN OTC DRUG Justice Fruit Punch Scented Anti bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170415 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60637-218_60ce836b-01da-fae9-e053-2a91aa0abb7a 60637-218 HUMAN OTC DRUG Justice Meow Mint Scented Anti-bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170415 OTC MONOGRAPH NOT FINAL part333E Tween Brands, Inc ALCOHOL 620 mg/mL N 20181231 60640-3688_771e79ab-4ac6-4439-8630-bbf579259fbe 60640-3688 HUMAN PRESCRIPTION DRUG Lollicaine Bubble Gum Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Centrix, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 60640-3690_771e79ab-4ac6-4439-8630-bbf579259fbe 60640-3690 HUMAN PRESCRIPTION DRUG Lollicaine Cherry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Centrix, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 60640-3692_771e79ab-4ac6-4439-8630-bbf579259fbe 60640-3692 HUMAN PRESCRIPTION DRUG Lollicaine Mint Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Centrix, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 60640-3694_771e79ab-4ac6-4439-8630-bbf579259fbe 60640-3694 HUMAN PRESCRIPTION DRUG Lollicaine Pina Colada Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Centrix, Inc. BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 60659-0101_b8cb8d26-d65b-43f8-9418-a48de7e6a62d 60659-0101 HUMAN OTC DRUG Bang Er Jie High-Efficiency Anti-Bacteria Monomer Silver Gel for Women Anti-Bacteria Monomer Silver Gel GEL, DENTIFRICE VAGINAL 20130923 UNAPPROVED HOMEOPATHIC Bang An Bao Medical Equipment Co., Ltd. SILVER 350 ug/3g E 20171231 60659-0102_f1b663a7-6eed-4cd0-927a-a0cae7bfc629 60659-0102 HUMAN OTC DRUG Bang Er Jie High-Efficiency Anti-Bacteria Monomer Silver -Lotion for Women Anti-Bacteria Monomer Silver Lotion LOTION VAGINAL 20130922 UNAPPROVED HOMEOPATHIC Bang An Bao Medical Equipment Co., Ltd. SILVER 20 mg/200mL E 20171231 60659-0201_998ca32e-7633-48ec-a4c7-16492a9f7547 60659-0201 HUMAN OTC DRUG Bang Lie An High-Efficiency Anti-Bacteria Monomer Silver Gel for Prostatitis High-Efficiency Anti-Bacteria Monomer Silver Gel for Prostatitis GEL, DENTIFRICE RECTAL 20160108 UNAPPROVED HOMEOPATHIC Bang An Bao Medical Equipment Co., Ltd. SILVER; WATER 1050; 2980950 ug/3g; ug/3g E 20171231 60659-0303_cf5848b6-abb9-4d65-ba79-f71186a5d267 60659-0303 HUMAN OTC DRUG Bi Fu Jian High-Efficiency Anti-Bacteria Monomer Silver Sprays for Rhinitis High-Efficiency Anti-Bacteria Monomer Silver Sprays for Rhinitis LIQUID NASAL 20160108 UNAPPROVED HOMEOPATHIC Bang An Bao Medical Equipment Co., Ltd. SILVER 1500 ug/15mL E 20171231 60660-7782_f262aad9-daa3-4099-8b1a-056aa5c03611 60660-7782 HUMAN OTC DRUG Calendula Calendula officinalis SUPPOSITORY RECTAL; VAGINAL 20090619 UNAPPROVED HOMEOPATHIC Wise Woman Herbals CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_X]/1 E 20171231 60660-7783_81a210f5-0917-42a5-a548-2edf1be85b9b 60660-7783 HUMAN OTC DRUG Double T Candida albicans, Thuja occidentalis SUPPOSITORY RECTAL; VAGINAL 20090629 UNAPPROVED HOMEOPATHIC Wise Woman Herbals CANDIDA ALBICANS; THUJA OCCIDENTALIS LEAFY TWIG 6; 6 [hp_C]/1; [hp_X]/1 E 20171231 60660-7784_09fbb116-5d61-47c1-a7ee-c54cf7598b4c 60660-7784 HUMAN OTC DRUG Healing Calendula officinalis, Silacea SUPPOSITORY RECTAL; VAGINAL 20090609 UNAPPROVED HOMEOPATHIC Wise Woman Herbals CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 6; 10 [hp_X]/1; [hp_X]/1 E 20171231 60660-7785_ef9de637-bd20-45d1-8be5-adb6b79373a3 60660-7785 HUMAN OTC DRUG 1 Echinacea, Hydrastis Canadensis SUPPOSITORY VAGINAL 20090626 UNAPPROVED HOMEOPATHIC Wise Woman Herbals ECHINACEA, UNSPECIFIED; GOLDENSEAL 6; 6 [hp_X]/1; [hp_X]/1 E 20171231 60660-7786_f4201e81-68ed-436e-8013-1c9b56534a4d 60660-7786 HUMAN OTC DRUG 2 Calcarea fluorica, Collinsonia canadensis, Hamamelis virginiana SUPPOSITORY RECTAL; VAGINAL 20090810 UNAPPROVED HOMEOPATHIC Wise Woman Herbals CALCIUM FLUORIDE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 12; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 60660-7787_f8888d47-f0ab-4c4b-8779-0fb740a4a024 60660-7787 HUMAN OTC DRUG Thuja Thuja occidentalis SUPPOSITORY RECTAL; VAGINAL 20091118 UNAPPROVED HOMEOPATHIC Wise Woman Herbals THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/1 E 20171231 60660-7788_d0742572-a04e-4be4-ba5a-a01bf117e54e 60660-7788 HUMAN OTC DRUG Vag Pack Hydrastis Canadensis SUPPOSITORY VAGINAL 20090717 UNAPPROVED HOMEOPATHIC Wise Woman Herbals GOLDENSEAL 6 [hp_X]/1 E 20171231 60665-001_39b9de6e-0f99-40ad-b8d4-9e7543c0b29b 60665-001 HUMAN OTC DRUG Sambrosa Sweet Dreams Nighttime Doxylamine succinate SYRUP ORAL 20150701 OTC MONOGRAPH FINAL part341 Sambrosa Care Inc. DOXYLAMINE SUCCINATE 9.75 mg/5mL N 20181231 60675-000_ad8d2e1a-4331-4b7d-af00-ad089e8355c8 60675-000 HUMAN OTC DRUG Paris Hand Sanitizer Vanilla Scent ALCOHOL GEL TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part333E Michaels Stores Procurement Company ALCOHOL 620 mg/mL E 20171231 60675-001_8296ef07-2fa7-4b2e-b066-cf94998c8562 60675-001 HUMAN OTC DRUG Tokyo Hand Sanitizer Vanilla Scent ALCOHOL GEL TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part333E Michaels Stores Procurement Company ALCOHOL 620 mg/mL E 20171231 60675-002_103d63aa-2be1-4213-a3ca-a6b75ca53d44 60675-002 HUMAN OTC DRUG I LOVE NY Hand Sanitizer Vanilla Scent ALCOHOL GEL TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part333E Michaels Stores Procurement Company ALCOHOL 620 mg/mL E 20171231 60675-003_06e90964-ee3d-4b3b-8228-ad0b9de22455 60675-003 HUMAN OTC DRUG LONDON Hand Sanitizer Vanilla Scent ALCOHOL GEL TOPICAL 20130911 OTC MONOGRAPH NOT FINAL part333E Michaels Stores Procurement Company ALCOHOL 620 mg/mL E 20171231 60675-004_998ae417-782e-4802-b6de-4308799742ca 60675-004 HUMAN OTC DRUG Hand Sanitizer Vanilla Scent ALCOHOL GEL TOPICAL 20140924 OTC MONOGRAPH NOT FINAL part333E Michaels Stores Procurement Company ALCOHOL 62 mL/100mL E 20171231 60675-005_3890ee68-964d-2d69-e054-00144ff88e88 60675-005 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER Alcohol LIQUID TOPICAL 20160718 OTC MONOGRAPH NOT FINAL part333A Michaels Stores Procurement Company ALCOHOL 62 g/100mL N 20181231 60675-006_38914de4-bf7c-46d4-e054-00144ff88e88 60675-006 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER Alcohol LIQUID TOPICAL 20160718 OTC MONOGRAPH NOT FINAL part333A Michaels Stores Procurement Company ALCOHOL 62 g/100mL N 20181231 60675-007_38912ab4-9c9d-4209-e054-00144ff88e88 60675-007 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER Alcohol LIQUID TOPICAL 20160718 OTC MONOGRAPH NOT FINAL part333A Michaels Stores Procurement Company ALCOHOL 62 g/100mL N 20181231 60675-008_3829a721-7341-1f79-e054-00144ff8d46c 60675-008 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER Alcohol LIQUID TOPICAL 20160718 OTC MONOGRAPH NOT FINAL part333A Michaels Stores Procurement Company ALCOHOL 62 g/100mL N 20181231 60675-009_3890ee68-9660-2d69-e054-00144ff88e88 60675-009 HUMAN OTC DRUG ANTI BACTERIAL HAND SANITIZER Alcohol LIQUID TOPICAL 20160718 OTC MONOGRAPH NOT FINAL part333A Michaels Stores Procurement Company ALCOHOL 62 g/100mL N 20181231 60681-0011_6c74c6f4-81a4-4421-9a8f-d9dd92065e56 60681-0011 HUMAN OTC DRUG Pleo Stolo penicillium brevicompactum SOLUTION/ DROPS ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM BREVICOMPACTUM 6 [hp_X]/10mL E 20171231 60681-0021_15f8962a-0abe-42cf-9766-15d8508ba34d 60681-0021 HUMAN OTC DRUG Pleo Oryzae aspergillus flavus var. oryzae SOLUTION/ DROPS ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS FLAVUS VAR. ORYZAE 6 [hp_X]/10mL E 20171231 60681-0031_65b23a17-dfdc-4fe5-86f6-08933ebd6bfa 60681-0031 HUMAN OTC DRUG Pleo Nota-Quent PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM and PENICILLIUM GLABRUM LIQUID ORAL 20120415 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM 5; 5 [hp_X]/mL; [hp_X]/mL E 20171231 60681-0101_515a3694-0e6f-46ec-a562-5ccaf1638b5a 60681-0101 HUMAN OTC DRUG Pleo Alb candida albicans SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 5 [HP_X]/10mL E 20171231 60681-0102_696611f6-3005-4492-81b7-c5a9eaf4c73d 60681-0102 HUMAN OTC DRUG Pleo Alb candida albicans CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 4 [HP_X]/1 E 20171231 60681-0103_9d8cfc6f-ce07-4da3-9b51-2cceff9115c3 60681-0103 HUMAN OTC DRUG Pleo Alb candida albicans SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 3 [hp_X]/1 E 20171231 60681-0104_45747833-10f1-4f74-a224-5fcc0badffbb 60681-0104 HUMAN OTC DRUG Pleo Alb candida albicans OINTMENT TOPICAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 3 [HP_X]/30g E 20171231 60681-0105_3a681a3a-ed5e-442f-8b25-d1cc4b440298 60681-0105 HUMAN OTC DRUG Pleo Alb candida albicans LIQUID ORAL 20040524 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 5 [hp_X]/mL E 20171231 60681-0111_6d9dea98-74a3-4cd0-9b21-7965d526ea31 60681-0111 HUMAN OTC DRUG Pleo Cal GIANT PUFFBALL SOLUTION/ DROPS ORAL 19980819 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG GIANT PUFFBALL 3 [hp_X]/10mL E 20171231 60681-0113_97db8584-c5e0-4d6b-8435-566f7614a27b 60681-0113 HUMAN OTC DRUG Pleo Cal CALVATIA GIGANTEA WHOLE TABLET ORAL 20120710 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG CALVATIA GIGANTEA WHOLE 4 [hp_X]/1 E 20171231 60681-0114_350040ca-a144-4342-a1e3-c8eef2263434 60681-0114 HUMAN OTC DRUG Pleo Form formic acid SOLUTION/ DROPS ORAL 20041209 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG FORMIC ACID 200 [hp_X]/30mL E 20171231 60681-0115_b1bf4a34-4d5c-4de2-bdb9-6a8ee5f9bbd6 60681-0115 HUMAN OTC DRUG Pleo Form formic acid KIT 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG E 20171231 60681-0122_89e189c7-53ee-4cf4-a664-734155a50998 60681-0122 HUMAN OTC DRUG Pleo Grif MAITAKE LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MAITAKE 5 [hp_X]/mL E 20171231 60681-0123_d4133eec-bf11-4802-a54a-63706c9a3010 60681-0123 HUMAN OTC DRUG Pleo Grif maitake SOLUTION/ DROPS ORAL 19980202 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MAITAKE 5 [hp_X]/10mL E 20171231 60681-0205_19d5e25c-9ab9-4fec-a990-aad30a93a1da 60681-0205 HUMAN OTC DRUG Pleo Art U Brevibacterium stationis LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BREVIBACTERIUM STATIONIS 6 [hp_X]/mL E 20171231 60681-0301_624cbab3-3afb-43b0-b339-ce0c47f08728 60681-0301 HUMAN OTC DRUG Pleo Art A propionibacterium acnes SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROPIONIBACTERIUM ACNES 6 [hp_X]/10mL E 20171231 60681-0302_75f7995f-d855-4908-92e4-3bef0c831180 60681-0302 HUMAN OTC DRUG Pleo Art A propionibacterium acnes LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROPIONIBACTERIUM ACNES 6 [hp_X]/mL E 20171231 60681-0401_af3ada15-2db9-4843-9f44-5ab428ac87aa 60681-0401 HUMAN OTC DRUG Pleo Art U Brevibacterium stationis SOLUTION/ DROPS ORAL 19970219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BREVIBACTERIUM STATIONIS 6 [hp_X]/10mL E 20171231 60681-0801_d0e7d190-9165-4804-ae04-6578b13cb664 60681-0801 HUMAN OTC DRUG Pleo Muscar AMANITA MUSCARIA WHOLE LIQUID ORAL 20120710 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG AMANITA MUSCARIA WHOLE 6 [hp_X]/10mL E 20171231 60681-0802_c29f15a9-6aa5-4dba-9616-2d0540131b27 60681-0802 HUMAN OTC DRUG Pleo Muscar amanita muscaria var. muscaria LIQUID ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG AMANITA MUSCARIA VAR. MUSCARIA 6 [hp_X]/mL E 20171231 60681-0901_73b79917-67b8-4112-9eec-02adbc2e6e18 60681-0901 HUMAN OTC DRUG Pleo Selene sodium selenite SOLUTION/ DROPS ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SODIUM SELENITE 4 [hp_X]/30mL E 20171231 60681-1001_0f11b256-9f93-4f77-87e8-a8bab35dd15b 60681-1001 HUMAN OTC DRUG Pleo Ex candida albicans, candida parapsilosis and penicillium roqueforti SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; PENICILLIUM ROQUEFORTI 3; 3; 3 [HP_X]/1; [HP_X]/1; [HP_X]/1 E 20171231 60681-1002_c49f549d-6bcf-4e32-a2af-f4fa2748fbd6 60681-1002 HUMAN OTC DRUG Pleo San Ger Germanium Citrate Lactate SOLUTION/ DROPS ORAL 19990519 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG GERMANIUM CITRATE LACTATE 6 [hp_X]/100mL E 20171231 60681-1003_5ac916ec-8252-4e53-8009-3cfb42347074 60681-1003 HUMAN OTC DRUG Pleo Ex candida albicans, candida parapsilosis, and penicillium roqueforti SOLUTION/ DROPS ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; PENICILLIUM ROQUEFORTI 5; 5; 5 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL E 20171231 60681-1005_612a8a21-a97d-4900-8cca-1a406eec738b 60681-1005 HUMAN OTC DRUG Pleo Ex candida albicans, candida parapsilosis and penicillium roqueforti LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; PENICILLIUM ROQUEFORTI 5; 5; 5 [HP_X]/mL; [HP_X]/mL; [HP_X]/mL E 20171231 60681-1071_dd9ad819-83d7-4c8c-af00-e200f2873adf 60681-1071 HUMAN OTC DRUG Pleo Cup copper gluconate SOLUTION/ DROPS ORAL 19980812 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG COPPER GLUCONATE 3 [hp_X]/30mL E 20171231 60681-1075_701aec1f-7638-4005-bd5a-9f16bf00e75b 60681-1075 HUMAN OTC DRUG Pleo Cup copper gluconate LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG COPPER GLUCONATE 4 [hp_X]/2mL E 20171231 60681-1086_cbf8a5ca-4a01-4d24-8224-822f91db8de6 60681-1086 HUMAN OTC DRUG Pleo Chrys human placenta hydrolysate LIQUID ORAL 20041015 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG HUMAN PLACENTA HYDROLYSATE 5 [hp_X]/2mL E 20171231 60681-1101_f9c345ae-2c9b-4df3-9395-9ccbb8f02184 60681-1101 HUMAN OTC DRUG Pleo Fort penicillium roqueforti SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG PENICILLIUM ROQUEFORTI 5 [HP_X]/10mL E 20171231 60681-1102_db6d1eaf-225e-4b82-b7b4-18ddcae52553 60681-1102 HUMAN OTC DRUG Pleo Fort penicillium roqueforti TABLET ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM ROQUEFORTI 5 [HP_X]/1 E 20171231 60681-1103_f0dbce71-9e88-4c14-b19e-0af1b7c82556 60681-1103 HUMAN OTC DRUG Pleo Fort penicillium roqueforti CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM ROQUEFORTI 4 [HP_X]/1 E 20171231 60681-1105_5966a4c4-a4ac-4cf6-a9e9-5e6dc9067c3f 60681-1105 HUMAN OTC DRUG Pleo Fort penicillium roqueforti LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM ROQUEFORTI 5 [hp_X]/mL E 20171231 60681-1106_99695141-20c2-4530-b3fb-66072a0860d9 60681-1106 HUMAN OTC DRUG Pleo Fort penicillium roqueforti SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM ROQUEFORTI 3 [hp_X]/1 E 20171231 60681-1204_640c82c3-ca2b-4d63-a24b-9e5a222a5a76 60681-1204 HUMAN OTC DRUG Pleo San MYC mycobacterium bovis SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM BOVIS 6 [hp_X]/10mL E 20171231 60681-1205_51ecc515-85cb-48d4-a2bc-c175d4949fc6 60681-1205 HUMAN OTC DRUG Pleo San Myc mycobacterium bovis LIQUID ORAL 20040421 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM BOVIS 5 [hp_X]/mL E 20171231 60681-1214_78385436-734d-4422-b69d-c86d63062314 60681-1214 HUMAN OTC DRUG Pleo San Klebs klebsiella pneumoniae SOLUTION/ DROPS ORAL 19970730 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG KLEBSIELLA PNEUMONIAE 6 [HP_X]/10mL E 20171231 60681-1215_46f126fd-f60c-497a-850e-ab11c4bc2a8e 60681-1215 HUMAN OTC DRUG Pleo San Klebs klebsiella pneumoniae LIQUID ORAL 20051101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG KLEBSIELLA PNEUMONIAE 6 [hp_X]/mL E 20171231 60681-1224_9c1c2e3d-614d-4e8e-97be-a8767c140297 60681-1224 HUMAN OTC DRUG Pleo San Coli escherichia coli SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ESCHERICHIA COLI 6 [HP_X]/10mL E 20171231 60681-1225_33cbf028-2354-455e-94c5-eb7cd490531b 60681-1225 HUMAN OTC DRUG Pleo San Coli escherichia coli LIQUID ORAL 20040524 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ESCHERICHIA COLI 7 [hp_X]/mL E 20171231 60681-1234_3f999fba-9d76-4f5b-a0e9-bd396a0ced24 60681-1234 HUMAN OTC DRUG Pleo San Brucel brucella melitensis SOLUTION/ DROPS ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BRUCELLA MELITENSIS 6 [HP_X]/10mL E 20171231 60681-1235_39d6abf5-44e9-4342-bf81-b0c106527d0b 60681-1235 HUMAN OTC DRUG Pleo San Brucel brucella melitensis LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BRUCELLA MELITENSIS 6 [hp_X]/mL E 20171231 60681-1244_95351bd8-45c3-4a41-97ff-20345278b7a6 60681-1244 HUMAN OTC DRUG Pleo San Prot proteus vulgaris SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROTEUS VULGARIS 6 [hp_X]/10mL E 20171231 60681-1245_56d99164-317a-44ff-9909-d7a2c8fcf604 60681-1245 HUMAN OTC DRUG Pleo San Prot proteus vulgaris LIQUID ORAL 20060101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROTEUS VULGARIS 7 [hp_X]/mL E 20171231 60681-1254_e15e1d5f-113a-4099-8aac-4341fe33b520 60681-1254 HUMAN OTC DRUG Pleo San Pseu pseudomonas aeruginosa SOLUTION/ DROPS ORAL 19970730 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PSEUDOMONAS AERUGINOSA 6 [hp_X]/10mL E 20171231 60681-1256_38cdb649-cbf4-4ae2-985a-62212d840fea 60681-1256 HUMAN OTC DRUG Pleo San Pseu pseudomonas aeruginosa LIQUID ORAL 20091201 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PSEUDOMONAS AERUGINOSA 6 [hp_X]/mL E 20171231 60681-1264_47d611f2-e495-4774-b0b3-acd9dd826a8f 60681-1264 HUMAN OTC DRUG Pleo San Salm salmonella enterica subsp. enterica serovar enteritidis SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 6 [hp_X]/10mL E 20171231 60681-1265_59be4fd4-ebd5-40d4-ba1a-49d3df58706a 60681-1265 HUMAN OTC DRUG Pleo San Salm salmonella enterica subsp. enterica serovar enteritidis LIQUID ORAL 20070430 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 6 [hp_X]/mL E 20171231 60681-1274_8aef1a1a-b23c-4434-adf9-75f7ce257ac3 60681-1274 HUMAN OTC DRUG Pleo San Serra serratia marcescens SOLUTION/ DROPS ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SERRATIA MARCESCENS 6 [HP_X]/10mL E 20171231 60681-1277_06169499-fd43-47ea-883c-0d6a9dc5b602 60681-1277 HUMAN OTC DRUG Pleo San Serra serratia marcescens LIQUID ORAL 20091201 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SERRATIA MARCESCENS 7 [hp_X]/mL E 20171231 60681-1284_c773add7-9d3c-4637-9e5d-650d15149748 60681-1284 HUMAN OTC DRUG Pleo San Staph staphylococcus aureus SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STAPHYLOCOCCUS AUREUS 6 [hp_X]/10mL E 20171231 60681-1285_7b5b993d-1e4c-4e03-b878-691cc6c07b52 60681-1285 HUMAN OTC DRUG Pleo San Staph staphylococcus aureus LIQUID ORAL 20061130 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STAPHYLOCOCCUS AUREUS 5 [hp_X]/mL E 20171231 60681-1294_93f69ba0-f484-499c-bdba-f2470253f665 60681-1294 HUMAN OTC DRUG Pleo San Strep streptococcus pyogenes SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STREPTOCOCCUS PYOGENES 6 [hp_X]/10mL E 20171231 60681-1295_bb24bd43-73db-4527-aa07-77433cff749d 60681-1295 HUMAN OTC DRUG Pleo San Strep streptococcus pyogenes LIQUID ORAL 19970430 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STREPTOCOCCUS PYOGENES 5 [hp_X]/mL E 20171231 60681-1301_47f56433-ea33-4cb6-b6fd-8283d2302936 60681-1301 HUMAN OTC DRUG Pleo Lari laricifomes officinalis fruiting body SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LARICIFOMES OFFICINALIS FRUITING BODY 5 [hp_X]/10mL E 20171231 60681-1302_1fe09bca-eab8-4547-83f2-f6dd80fc6494 60681-1302 HUMAN OTC DRUG Pleo Lari laricifomes officinalis fruiting body CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LARICIFOMES OFFICINALIS FRUITING BODY 4 [hp_X]/1 E 20171231 60681-1303_69bc6646-2db4-4d93-a009-4adb904c87cb 60681-1303 HUMAN OTC DRUG Pleo Lari laricifomes officinalis fruiting body LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LARICIFOMES OFFICINALIS FRUITING BODY 5 [hp_X]/mL E 20171231 60681-1304_62dda172-b7ba-4642-8444-1a8c49e64e06 60681-1304 HUMAN OTC DRUG Pleo San Trich Trichophyton Verrucosum SOLUTION/ DROPS ORAL 19970919 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG TRICHOPHYTON VERRUCOSUM 6 [hp_X]/10mL E 20171231 60681-1305_7d75e786-dfd3-427b-b61e-e0153fd52737 60681-1305 HUMAN OTC DRUG Pleo San Trich Trichophyton Verrucosum LIQUID ORAL 19970430 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG TRICHOPHYTON VERRUCOSUM 5 [hp_X]/mL E 20171231 60681-1311_add41509-5db5-4ee1-a7d9-9718a6a389b4 60681-1311 HUMAN OTC DRUG Pleo Spermus Manuka Oil SOLUTION/ DROPS ORAL 20060101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MANUKA OIL 1 [hp_X]/30mL E 20171231 60681-1315_766f3cbf-0121-435e-8e23-da4625399111 60681-1315 HUMAN OTC DRUG Pleo San Cand candida albicans LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 5 [hp_X]/mL E 20171231 60681-1316_3e382f17-20e5-4eb7-b6a3-8e4915220aea 60681-1316 HUMAN OTC DRUG Pleo San Cand candida albicans SOLUTION/ DROPS ORAL 19970901 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG CANDIDA ALBICANS 6 [hp_X]/10mL E 20171231 60681-1401_18279799-5076-4ae7-be08-f334fc893cd0 60681-1401 HUMAN OTC DRUG Pleo Lat BACILLUS CEREUS SOLUTION/ DROPS ORAL 19961213 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS CEREUS 6 [hp_X]/5mL E 20171231 60681-1402_164e5b41-df7b-4e73-aa04-b72762e6f8b4 60681-1402 HUMAN OTC DRUG Pleo Lat bacillus cereus CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS CEREUS 4 [HP_X]/1 E 20171231 60681-1403_80f10916-4b22-4ac3-944f-216b8ecccc76 60681-1403 HUMAN OTC DRUG Pleo Lat bacillus cereus CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS CEREUS 6 [HP_X]/1 E 20171231 60681-1404_95ac6a55-6785-4933-8101-131648e12413 60681-1404 HUMAN OTC DRUG Pleo Lat bacillus cereus SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS CEREUS 6 [hp_X]/1 E 20171231 60681-1405_27fa14da-5e6a-49c1-8e51-04ee1e20ce36 60681-1405 HUMAN OTC DRUG Pleo Lat bacillus cereus LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS CEREUS 6 [hp_X]/mL E 20171231 60681-1407_7e186d46-00cd-4888-ba62-35ddf1ed016b 60681-1407 HUMAN OTC DRUG Pleo Lat bacillus cereus LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS CEREUS 4 [hp_X]/mL E 20171231 60681-1601_60d43733-b29f-4dae-915e-a608e89aa2ae 60681-1601 HUMAN OTC DRUG Pleo Leptu propionibacterium avidum CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROPIONIBACTERIUM AVIDUM 6 [HP_X]/1 E 20171231 60681-1602_f2bee966-9d17-4bcf-93f7-b7522beddc15 60681-1602 HUMAN OTC DRUG Pleo Leptu propionibacterium avidum SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROPIONIBACTERIUM AVIDUM 6 [HP_X]/1 E 20171231 60681-1701_7fd93bd9-9d01-4bb4-b664-044eccdea2c8 60681-1701 HUMAN OTC DRUG Pleo Mucedo RHIZOPUS STOLONIFER SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG RHIZOPUS STOLONIFER 5 [HP_X]/10mL E 20171231 60681-1702_a0628534-2d41-4d9f-92c2-34a32eb7583c 60681-1702 HUMAN OTC DRUG Pleo Mucedo rhizopus stolonifer CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG RHIZOPUS STOLONIFER 4 [HP_X]/1 E 20171231 60681-1703_f1336af0-a1cc-413d-95b8-8a86c40b8412 60681-1703 HUMAN OTC DRUG Pleo Mucedo rhizopus stolonifer SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG RHIZOPUS STOLONIFER 3 [HP_X]/1 E 20171231 60681-1704_32e6a14b-d9c7-4aee-9102-983aec01f7b6 60681-1704 HUMAN OTC DRUG Pleo Mucedo rhizopus stolonifer LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG RHIZOPUS STOLONIFER 5 [hp_X]/mL E 20171231 60681-1801_5c32e3e8-2f06-4581-a6a3-242114090ffe 60681-1801 HUMAN OTC DRUG Pleo Muc mucor racemosus SOLUTION/ DROPS ORAL 19960209 UNAPPROVED HOMEOPATHIC SANUM-KEHLBECK GMBH & CO KG MUCOR RACEMOSUS 5 [HP_X]/10mL E 20171231 60681-1802_9c286f03-fd08-486f-9e2b-96e8208cc927 60681-1802 HUMAN OTC DRUG Pleo Muc mucor racemosus SOLUTION/ DROPS OPHTHALMIC 19960309 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 5 [hp_X]/5mL E 20171231 60681-1803_e001193f-7430-4f1f-93bc-6d1b65c3b44f 60681-1803 HUMAN OTC DRUG Pleo Muc mucor racemosus TABLET ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 5 [HP_X]/1 E 20171231 60681-1804_edba6598-8a27-497b-9cf4-7ba82006f73e 60681-1804 HUMAN OTC DRUG Pleo Muc mucor racemosus CAPSULE ORAL 19960301 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 4 [HP_X]/1 E 20171231 60681-1805_d46d19b4-989a-434a-a7ee-700511a7d07d 60681-1805 HUMAN OTC DRUG Pleo Muc mucor racemosus SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 3 [hp_X]/1 E 20171231 60681-1806_908ba301-8281-4f4e-9209-84e904c911cf 60681-1806 HUMAN OTC DRUG Pleo Muc mucor racemosus OINTMENT TOPICAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 3 [hp_X]/30g E 20171231 60681-1807_b3c388cb-fb2d-4be0-bbeb-4212ce2f672f 60681-1807 HUMAN OTC DRUG Pleo Muc mucor racemosus LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 5 [hp_X]/mL E 20171231 60681-1808_a8a79364-5ca1-4a76-af1c-25db78dc6e39 60681-1808 HUMAN OTC DRUG Pleo Muc mucor racemosus LIQUID ORAL 19980101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 7 [hp_X]/mL E 20171231 60681-1809_b343d7d4-238f-4c26-a7a0-d7e1609f3bb1 60681-1809 HUMAN OTC DRUG Pleo Muc mucor racemosus LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS 6 [hp_X]/mL E 20171231 60681-1822_dea129c9-a1e4-447f-99c5-d87c4f19fc32 60681-1822 HUMAN OTC DRUG Pleo Muc mucor racemosus LIQUID OPHTHALMIC 20110615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co KG MUCOR RACEMOSUS 5 [hp_X]/mL E 20171231 60681-1901_9a7fff02-125c-461e-a93a-f745a2383298 60681-1901 HUMAN OTC DRUG Pleo Muc Ex Mucor racemosus immunoserum rabbit SOLUTION/ DROPS ORAL 19980812 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS IMMUNOSERUM RABBIT 6 [hp_X]/10mL E 20171231 60681-1905_5a555ef5-4cc2-434f-8370-0c50df2202de 60681-1905 HUMAN OTC DRUG Pleo Muc Ex Mucor racemosus immunoserum rabbit LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS IMMUNOSERUM RABBIT 6 [hp_X]/mL E 20171231 60681-2101_f6b1a16f-a6d4-4084-8fb9-8dc6ad956722 60681-2101 HUMAN OTC DRUG Pleo Nig aspergillus niger var. niger SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER 5 [HP_X]/10mL E 20171231 60681-2102_e5c16ad8-763d-4887-b2fd-e6e97f53fd23 60681-2102 HUMAN OTC DRUG Pleo Nig aspergillus niger var. niger TABLET ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER 5 [HP_X]/1 E 20171231 60681-2103_f9361bb9-2c5a-4983-8d8b-0ace0b71031b 60681-2103 HUMAN OTC DRUG Pleo Nig aspergillus niger var. niger CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER 4 [HP_X]/1 E 20171231 60681-2104_ea9a4acb-8ae4-4012-8be8-eb067e10e957 60681-2104 HUMAN OTC DRUG Pleo Nig Aspergillus Niger Var. Niger SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER 3 [hp_X]/1 E 20171231 60681-2105_0e57719d-2c7e-4083-9c03-09246aaea7be 60681-2105 HUMAN OTC DRUG Pleo Nig aspergillus niger SOLUTION/ DROPS ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER 5 [hp_X]/mL E 20171231 60681-2106_c61152e0-1aad-4d81-9436-07ab4185a9cc 60681-2106 HUMAN OTC DRUG Pleo Nig aspergillus niger var. niger SOLUTION/ DROPS ORAL 20040421 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER 7 [HP_X]/mL E 20171231 60681-2107_59218acd-3120-4361-9da6-1380a371c9fb 60681-2107 HUMAN OTC DRUG Pleo Nig aspergillus niger var. niger SOLUTION/ DROPS ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER VAR. NIGER 6 [HP_X]/mL E 20171231 60681-2111_51b47753-af68-46bb-a361-6141c1c28f4a 60681-2111 HUMAN OTC DRUG Pleo Nig Ex Aspergillus niger immunoserum rabbit LIQUID ORAL 19980819 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER IMMUNOSERUM RABBIT 6 [hp_X]/mL E 20171231 60681-2112_a5d3a0a6-6692-4ef6-b1ce-d987e9e3909c 60681-2112 HUMAN OTC DRUG Pleo Nig Ex Aspergillus niger immunoserum rabbit SOLUTION/ DROPS ORAL 19980812 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS NIGER IMMUNOSERUM RABBIT 6 [hp_X]/10mL E 20171231 60681-2301_790689dc-0b81-4d64-9753-d5609c7cc385 60681-2301 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 5 [HP_X]/10mL E 20171231 60681-2302_69e09f1a-fb20-46c5-a5a9-b941c6b815b5 60681-2302 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum TABLET ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 5 [HP_X]/1 E 20171231 60681-2303_c5b2c58c-7ab5-4772-a9a7-f9012806e279 60681-2303 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [HP_X]/1 E 20171231 60681-2304_b97961d7-1849-4092-965a-55bc4b42e6c7 60681-2304 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 3 [hp_X]/1 E 20171231 60681-2305_82d417ae-9374-45b4-943f-3d4991b346d0 60681-2305 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum OINTMENT TOPICAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 3 [HP_X]/30g E 20171231 60681-2306_4744f01c-ed90-420d-9272-559f823636e7 60681-2306 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum LIQUID ORAL 20051101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 5 [hp_X]/mL E 20171231 60681-2308_78c3cf26-27fc-4a92-8a2f-404fd6a37e35 60681-2308 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 6 [hp_X]/mL E 20171231 60681-2310_40220dfc-2900-4224-85d5-c3e716fe188f 60681-2310 HUMAN OTC DRUG Pleo Not penicillium chrysogenum var. chrysogenum LIQUID ORAL 19971219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 7 [hp_X]/mL E 20171231 60681-2401_1bdccfcb-ad36-4760-a746-c699b708a215 60681-2401 HUMAN OTC DRUG Pleo Oku OKOUBAKA AUBREVILLEI BARK SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG OKOUBAKA AUBREVILLEI BARK 2 [hp_X]/30mL E 20171231 60681-2402_47621cb8-49dd-48fe-84a1-6be6402f2fc3 60681-2402 HUMAN OTC DRUG Pleo Oku OKOUBAKA AUBREVILLEI BARK TABLET ORAL 20120710 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG OKOUBAKA AUBREVILLEI BARK 2 [hp_X]/1 E 20171231 60681-2501_a0bab26f-0b21-41dd-87c9-727e6a675f8c 60681-2501 HUMAN OTC DRUG Pleo Pef CANDIDA PARAPSILOSIS SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA PARAPSILOSIS 5 [HP_X]/10mL E 20171231 60681-2502_1277da1b-6e57-4a62-ab00-cef349fc6b52 60681-2502 HUMAN OTC DRUG Pleo Pef candida parapsilosis CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA PARAPSILOSIS 4 [HP_X]/1 E 20171231 60681-2503_d6dcb2c9-a51b-4f9d-8dbb-aa9e08fdbdd9 60681-2503 HUMAN OTC DRUG Pleo Pef candida parapsilosis SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA PARAPSILOSIS 3 [hp_X]/1 E 20171231 60681-2504_d7527fc7-f0a8-45a0-bd7f-153919514458 60681-2504 HUMAN OTC DRUG Pleo Pef candida parapsilosis OINTMENT TOPICAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA PARAPSILOSIS 3 [HP_X]/30g E 20171231 60681-2505_88ceb47a-16f4-4ce3-b739-1e1e4b29af4e 60681-2505 HUMAN OTC DRUG Pleo Pef candida parapsilosis LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CANDIDA PARAPSILOSIS 6 [hp_X]/mL E 20171231 60681-2701_d9b525db-096b-443b-b3c7-4353c8cf67b0 60681-2701 HUMAN OTC DRUG Pleo Pin FOMITOPSIS PINICOLA SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG FOMITOPSIS PINICOLA 5 [HP_X]/10mL E 20171231 60681-2702_71ade6c3-2937-47a6-a921-17804fcb20a8 60681-2702 HUMAN OTC DRUG Pleo Pin fomitopsis pinicola CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG FOMITOPSIS PINICOLA 4 [HP_X]/1 E 20171231 60681-2703_d555121b-fdd5-4098-8d79-2b3a9df3575d 60681-2703 HUMAN OTC DRUG Pleo Pin fomitopsis pinicola SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG FOMITOPSIS PINICOLA 4 [hp_X]/1 E 20171231 60681-2705_ffd0f45c-90f2-486c-820c-f2cd83d52544 60681-2705 HUMAN OTC DRUG Pleo Pin fomitopsis pinicola fruiting body LIQUID ORAL 19971219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG FOMITOPSIS PINICOLA FRUITING BODY 5 [hp_X]/mL E 20171231 60681-2801_9d56e0a0-65ba-48cf-b473-419f10f342ae 60681-2801 HUMAN OTC DRUG Pleo Poly A mycobacterium bovis immunoserum rabbit and mycobacterium microti immunoserum rabbit SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM BOVIS IMMUNOSERUM RABBIT; MYCOBACTERIUM MICROTI IMMUNOSERUM RABBIT 9; 9 [hp_X]/10mL; [hp_X]/10mL E 20171231 60681-2802_5fbbdfd8-6337-43b8-94ed-34651e29721b 60681-2802 HUMAN OTC DRUG Pleo Poly D lactococcus lactis immunoserum rabbit, streptococcus pyogenes immunoserum rabbit, streptococcus viridans group immunoserum rabbit, staphylococcus epidermidis immunoserum rabbit, staphylococcus aureus SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LACTOCOCCUS LACTIS IMMUNOSERUM RABBIT; STREPTOCOCCUS PYOGENES IMMUNOSERUM RABBIT; STREPTOCOCCUS VIRIDANS GROUP IMMUNOSERUM RABBIT; STAPHYLOCOCCUS EPIDERMIDIS IMMUNOSERUM RABBIT; STAPHYLOCOCCUS AUREUS IMMUNOSERUM RABBIT; STREPTOCOCCUS PNEUMONIAE IMMUNOSERUM RABBIT; MYCOBACTERIUM BOVIS IMMUNOSERUM RABBIT 9; 9; 9; 9; 9; 9; 9 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL E 20171231 60681-2803_8941d7e0-ce8f-47fe-ba0b-f53fcc3d86f9 60681-2803 HUMAN OTC DRUG Pleo Poly Dx streptococcus pneumoniae immunoserum rabbit and staphylococcus aureus immunoserum rabbit SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STREPTOCOCCUS PNEUMONIAE IMMUNOSERUM RABBIT; STAPHYLOCOCCUS AUREUS IMMUNOSERUM RABBIT 9; 9 [hp_X]/10mL; [hp_X]/10mL E 20171231 60681-2804_89d0830d-c768-4526-a4ae-7654c9e00cb6 60681-2804 HUMAN OTC DRUG Pleo Poly E treponema pallidum immunoserum rabbit SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG TREPONEMA PALLIDUM IMMUNOSERUM RABBIT 9 [hp_X]/10mL E 20171231 60681-2805_8db3ba35-4cb4-4742-a2cd-3075409cd0fb 60681-2805 HUMAN OTC DRUG Pleo Poly G influenza A/B virus immunoserum rabbit, haemophilus influenzae immunoserum rabbit, and klebsiella pneumoniae SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG INFLUENZA A/B VIRUS IMMUNOSERUM RABBIT; HAEMOPHILUS INFLUENZAE IMMUNOSERUM RABBIT; KLEBSIELLA PNEUMONIAE 9; 9; 9 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL E 20171231 60681-2806_72546726-32dc-4626-955a-2d873310d75b 60681-2806 HUMAN OTC DRUG Pleo Poly K streptococcus pneumoniae immunoserum rabbit and staphylococcus aureus immunoserum rabbit SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STREPTOCOCCUS PNEUMONIAE IMMUNOSERUM RABBIT; STAPHYLOCOCCUS AUREUS IMMUNOSERUM RABBIT 9; 9 [hp_X]/10mL; [hp_X]/10mL E 20171231 60681-2807_d32bec3f-e6e0-4a91-9996-536c40566c14 60681-2807 HUMAN OTC DRUG Pleo Poly M malarial plasmodium group immunoserum rabbit OINTMENT TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MALARIAL PLASMODIUM GROUP IMMUNOSERUM RABBIT 9 [hp_X]/10mL E 20171231 60681-2808_bb2c59f0-e661-46e7-a137-09cee6b48b50 60681-2808 HUMAN OTC DRUG Pleo Poly Om lactococcus lactis immunoserum rabbit, streptococcus pyogenes immunoserum rabbit, streptococcus viridans group immunoserum rabbit, staphylococcus epidermidis immunoserum rabbit, staphylococcus aureus SOLUTION/ DROPS TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LACTOCOCCUS LACTIS IMMUNOSERUM RABBIT; STREPTOCOCCUS PYOGENES IMMUNOSERUM RABBIT; STREPTOCOCCUS VIRIDANS GROUP IMMUNOSERUM RABBIT; STAPHYLOCOCCUS EPIDERMIDIS IMMUNOSERUM RABBIT; STAPHYLOCOCCUS AUREUS IMMUNOSERUM RABBIT; STREPTOCOCCUS PNEUMONIAE IMMUNOSERUM RABBIT; MYCOBACTERIUM BOVIS IMMUNOSERUM RABBIT 9; 9; 9; 9; 9; 9; 9 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL E 20171231 60681-2809_3ca665c4-c93c-4903-8223-f2bfc6cf9a23 60681-2809 HUMAN OTC DRUG Pleo Poly R mycobacterium bovis immunoserum rabbit, mycobacterium microti immunoserum rabbit, and streptococcus pyogenes immunoserum rabbit LIQUID TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM BOVIS IMMUNOSERUM RABBIT; MYCOBACTERIUM MICROTI IMMUNOSERUM RABBIT; STREPTOCOCCUS PYOGENES IMMUNOSERUM RABBIT 9; 9; 9 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL E 20171231 60681-2810_b177c431-160e-49b0-a794-8ed80387d88e 60681-2810 HUMAN OTC DRUG Pleo Poly T mycobacterium microti immunoserum rabbit, mycobacterium bovis immunoserum rabbit, and streptococcus pyogenes immunoserum rabbit LIQUID TOPICAL 19990407 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM MICROTI IMMUNOSERUM RABBIT; MYCOBACTERIUM BOVIS IMMUNOSERUM RABBIT; STREPTOCOCCUS PYOGENES IMMUNOSERUM RABBIT 9; 9; 9 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL E 20171231 60681-2901_334e76ae-5c1e-42fd-a383-8b07320b1986 60681-2901 HUMAN OTC DRUG Pleo Quent PENICILLIUM GLABRUM SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM GLABRUM 5 [hp_X]/10mL E 20171231 60681-2902_ef5f8d62-eb6b-4302-8168-6792719cb163 60681-2902 HUMAN OTC DRUG Pleo Quent penicillium glabrum CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM GLABRUM 4 [hp_X]/1 E 20171231 60681-2904_a02241e3-98bd-4ab6-9a22-3d3f9674d2a3 60681-2904 HUMAN OTC DRUG Pleo Quent penicillium glabrum SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM GLABRUM 3 [HP_X]/1 E 20171231 60681-2905_21fa85bd-7917-4be2-9a2b-df795c9b8146 60681-2905 HUMAN OTC DRUG Pleo Quent PENICILLIUM GLABRUM LIQUID ORAL 19971219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PENICILLIUM GLABRUM 5 [hp_X]/mL E 20171231 60681-3001_2f76a543-9e89-4de3-9ebd-642bb4504030 60681-3001 HUMAN OTC DRUG Pleo Reb sus scrofa small intestine mucosa lymph follicle CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE 4 [hp_X]/1 E 20171231 60681-3003_97d33857-345d-47e8-b89b-ed24afdabd9e 60681-3003 HUMAN OTC DRUG Pleo Reb sus scrofa small intestine mucosa lymph follicle SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE 4 [hp_X]/1 E 20171231 60681-3006_7b2a6c35-b60b-406c-9714-a040b776dea5 60681-3006 HUMAN OTC DRUG Pleo Reb sus scrofa small intestine mucosa lymph follicle LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE 5 [hp_X]/2mL E 20171231 60681-3007_65e3613f-918d-4822-89d1-68c67c3bc141 60681-3007 HUMAN OTC DRUG Pleo Reb sus scrofa small intestine mucosa lymph follicle LIQUID ORAL 20060101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE 12 [hp_X]/2mL E 20171231 60681-3101_710a9906-e7bb-49e1-986e-a15eff2bf99a 60681-3101 HUMAN OTC DRUG Pleo Rec BACILLUS FIRMUS SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS FIRMUS 6 [hp_X]/5mL E 20171231 60681-3102_9f7f68c3-e9ba-4930-85cc-01d791eda926 60681-3102 HUMAN OTC DRUG Pleo Rec bacillus firmus CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS FIRMUS 4 [hp_X]/1 E 20171231 60681-3103_f9ef983c-4e25-4d35-a3e2-9ca6d213c52a 60681-3103 HUMAN OTC DRUG Pleo Rec bacillus firmus CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS FIRMUS 6 [hp_X]/1 E 20171231 60681-3104_d566ad23-78f0-417c-979e-909c9d9e5f9f 60681-3104 HUMAN OTC DRUG Pleo Rec bacillus firmus SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS FIRMUS 6 [HP_X]/1 E 20171231 60681-3105_7ba62913-b6ac-47d9-8dd8-1ae54a7f1a36 60681-3105 HUMAN OTC DRUG Pleo Rec bacillus firmus LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS FIRMUS 4 [hp_X]/mL E 20171231 60681-3301_995e1a1d-304a-44f0-875a-6c02fc15a38f 60681-3301 HUMAN OTC DRUG Pleo Rub aspergillus ruber SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS RUBER 5 [hp_X]/10mL E 20171231 60681-3302_5b83fa1f-c026-4955-9112-fb7b36881714 60681-3302 HUMAN OTC DRUG Pleo Rub aspergillus ruber SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS RUBER 3 [HP_X]/1 E 20171231 60681-3303_23fbff25-a8d6-4d31-82a6-440a89f227f9 60681-3303 HUMAN OTC DRUG Pleo Rub aspergillus ruber LIQUID ORAL 20060101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ASPERGILLUS RUBER 5 [hp_X]/mL E 20171231 60681-3401_1003de98-96f7-4640-964f-97f8bb0eab2d 60681-3401 HUMAN OTC DRUG Pleo Sancom mucor racemosus and aspergillus niger var. niger SOLUTION/ DROPS ORAL 19961219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MUCOR RACEMOSUS; ASPERGILLUS NIGER VAR. NIGER 5; 5 [hp_X]/10mL; [hp_X]/10mL E 20171231 60681-3601_cb472270-9e6f-49a8-b63b-ea0c803b2092 60681-3601 HUMAN OTC DRUG Pleo San Acne propionibacterium acnes SOLUTION/ DROPS ORAL 19961219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROPIONIBACTERIUM ACNES 6 [hp_X]/10mL E 20171231 60681-3602_59c46a55-feb4-4fa1-acb6-a8d39eb9b980 60681-3602 HUMAN OTC DRUG Pleo San Acne propionibacterium acnes LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG PROPIONIBACTERIUM ACNES 5 [hp_X]/mL E 20171231 60681-3701_4082ceca-f55c-454a-bd38-7b87c65b3e4c 60681-3701 HUMAN OTC DRUG Pleo Rec bacillus firmus LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS FIRMUS 6 [hp_X]/mL E 20171231 60681-5002_2b04f958-b5a3-4e9a-9396-59b02bb35251 60681-5002 HUMAN OTC DRUG PLEO THYM BOS TAURUS THYMUS SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BOS TAURUS THYMUS 6 [hp_X]/1 E 20171231 60681-5005_1d169fbe-e86f-430a-8ddc-ed4099dc6d6b 60681-5005 HUMAN OTC DRUG Pleo Thym BOS TAURUS THYMUS LIQUID ORAL 19980420 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BOS TAURUS THYMUS 6 [hp_X]/2mL E 20171231 60681-5101_b17a42a5-eff5-4604-8b6a-69459cc8d4b3 60681-5101 HUMAN OTC DRUG Pleo Usnea usnea barbata SOLUTION/ DROPS ORAL 19961213 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG USNEA BARBATA 1 [HP_X]/30mL E 20171231 60681-5200_fa7969df-572f-47f2-a670-0ca180d5d829 60681-5200 HUMAN OTC DRUG Pleo Thym thymus extract CAPSULE ORAL 19961213 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG THYMUS EXTRACT 6 [HP_X]/1 E 20171231 60681-5301_f8f9ef39-0eb5-4596-bd05-4b8b37facc3b 60681-5301 HUMAN OTC DRUG Pleo Ut bacillus subtilis SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS SUBTILIS 6 [hp_X]/5mL E 20171231 60681-5302_8c87f0eb-b4a4-4ae4-965e-07b2280907d9 60681-5302 HUMAN OTC DRUG Pleo Ut bacillus subtilis CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS SUBTILIS 4 [hp_X]/1 E 20171231 60681-5303_a4a1b886-1f1a-4970-962e-bc9588708586 60681-5303 HUMAN OTC DRUG Pleo Ut bacillus subtilis CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS SUBTILIS 6 [hp_X]/1 E 20171231 60681-5304_de7c7e2b-ca7c-47a5-970a-d0cbb015252c 60681-5304 HUMAN OTC DRUG Pleo Ut bacillus subtilis SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS SUBTILIS 6 [HP_X]/1 E 20171231 60681-5305_a6948542-9728-45e9-b95f-ec8f0fef40dd 60681-5305 HUMAN OTC DRUG Pleo Ut bacillus subtilis LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS SUBTILIS 4 [hp_X]/mL E 20171231 60681-5307_eb145c0d-3ef3-4b61-8343-069514aba01c 60681-5307 HUMAN OTC DRUG Pleo Ut bacillus subtilis LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG BACILLUS SUBTILIS 6 [hp_X]/mL E 20171231 60681-5401_4e8630e4-ed27-41fa-a0a9-a4c9b844caaf 60681-5401 HUMAN OTC DRUG Pleo Ut S mycobacterium phlei SOLUTION/ DROPS ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM PHLEI 6 [hp_X]/5mL E 20171231 60681-5402_3ce3d4a0-4802-4258-84ea-7b565ac19501 60681-5402 HUMAN OTC DRUG Pleo Ut S mycobacterium phlei CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM PHLEI 4 [hp_X]/1 E 20171231 60681-5403_04ec67e5-8994-404b-a697-73c4bf70e9e1 60681-5403 HUMAN OTC DRUG Pleo Ut S mycobacterium phlei CAPSULE ORAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM PHLEI 6 [hp_X]/1 E 20171231 60681-5404_809d46d6-9a25-430c-b701-5e248038cbdd 60681-5404 HUMAN OTC DRUG Pleo Ut S mycobacterium phlei SUPPOSITORY RECTAL 19960319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM PHLEI 6 [HP_X]/1 E 20171231 60681-5405_72be2eeb-00cc-4d36-aab7-bf05df47bb48 60681-5405 HUMAN OTC DRUG Pleo Ut S mycobacterium phlei LIQUID ORAL 20051101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM PHLEI 4 [hp_X]/mL E 20171231 60681-5407_955446fc-5f68-4100-b708-8b1602ffc9f8 60681-5407 HUMAN OTC DRUG Pleo Ut S mycobacterium phlei SOLUTION/ DROPS ORAL 20051101 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MYCOBACTERIUM PHLEI 6 [hp_X]/mL E 20171231 60681-5501_4df558df-6c72-4b74-b0a0-ae2ad55a9b98 60681-5501 HUMAN OTC DRUG Pleo Zinc zinc LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ZINC 4 [hp_X]/2mL E 20171231 60681-5502_b46d942a-3995-4d07-adc1-6d1794a6af37 60681-5502 HUMAN OTC DRUG Pleo Zinc zinc gluconate SOLUTION/ DROPS ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG ZINC GLUCONATE 3 [hp_X]/30mL E 20171231 60681-5601_7b103d01-a1ae-49ed-8698-46d8227a5bd8 60681-5601 HUMAN OTC DRUG Pleo Usti ustilago maydis SOLUTION/ DROPS ORAL 19980819 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG USTILAGO MAYDIS 5 [hp_X]/10mL E 20171231 60681-5603_c44bf99d-7fef-477e-abf2-7d79fd15e2d5 60681-5603 HUMAN OTC DRUG Pleo Usti ustilago maydis SOLUTION/ DROPS ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG USTILAGO MAYDIS 5 [HP_X]/10mL E 20171231 60681-5604_c720aca5-a43e-47d2-8928-ed6182ba5e5c 60681-5604 HUMAN OTC DRUG Pleo Usti ustilago maydis SUPPOSITORY RECTAL 20040421 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG USTILAGO MAYDIS 5 [HP_X]/1 E 20171231 60681-5701_abab75e4-2a2b-4f80-83dd-1438222c78cf 60681-5701 HUMAN OTC DRUG Pleo Ver Trichophyton Verrucosum SOLUTION/ DROPS ORAL 20110201 UNAPPROVED DRUG OTHER SANUM-KEHLBECK GMBH & CO KG TRICHOPHYTON VERRUCOSUM 6 [hp_X]/10mL E 20171231 60681-6001_10098eed-072a-409e-8873-02a570e3c285 60681-6001 HUMAN OTC DRUG Pleo Alkala Antacid sodium bicarbonate, potassium bicarbonate and sodium citrate POWDER ORAL 19961219 OTC MONOGRAPH FINAL part331 Sanum Kehlbeck GmbH & Co. KG SODIUM BICARBONATE; POTASSIUM BICARBONATE; SODIUM CITRATE 11.7; 117; 2.4 g/150g; g/150g; g/150g E 20171231 60681-6100_cb92989a-98b5-46d3-82e8-cbedde97d667 60681-6100 HUMAN OTC DRUG Pleo Chelate magnesium sulfate, potassium chloride and sodium chloride SOLUTION/ DROPS ORAL 19961231 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE 2; 2; 2 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 60681-6200_5b89aff2-2715-4732-aef1-73cada3ca3d0 60681-6200 HUMAN OTC DRUG Pleo Relivora drosera rotundifolia, echinacea angustifolia root and english walnut SOLUTION/ DROPS ORAL 19961231 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA ROOT; ENGLISH WALNUT 3; 2; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 60681-6201_88957f1b-2e09-4ba3-bbc7-5b902de2d795 60681-6201 HUMAN OTC DRUG Pleo Relivora Complex drosera rotundifolia, echinacea angustifolia root and english walnut LIQUID ORAL 19970102 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA ROOT; ENGLISH WALNUT 3; 4; 4 [hp_X]/2mL; [hp_X]/2mL; [hp_X]/2mL E 20171231 60681-6300_07979e63-5919-4479-a97b-287e56e0b182 60681-6300 HUMAN OTC DRUG Pleo Sanuvis lactic acid, l- KIT 19970219 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG E 20171231 60681-6301_3d49e515-0833-4585-bcbd-e8382a0bb006 60681-6301 HUMAN OTC DRUG Pleo Sanuvis lactic acid, l- OINTMENT TOPICAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LACTIC ACID, L- 1 [hp_X]/30g E 20171231 60681-6302_fa8b2bd5-bd6e-481a-a140-6d2f942c9391 60681-6302 HUMAN OTC DRUG Pleo Sanuvis lactic acid, l- KIT 20040524 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG E 20171231 60681-6303_cf624845-c731-43a4-b2e2-b5a93d4ebc52 60681-6303 HUMAN OTC DRUG Pleo Sanuvis lactic acid, l- TABLET ORAL 20100615 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG LACTIC ACID, L- 200 [hp_X]/1 E 20171231 60681-7001_d4433eb6-d5af-442d-896c-58d338e51c73 60681-7001 HUMAN OTC DRUG Pleo Cerivi Cetraria islandica subsp. islandica SOLUTION/ DROPS ORAL 19971231 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CETRARIA ISLANDICA SUBSP. ISLANDICA 1 [hp_X]/30mL E 20171231 60681-7002_2d067039-1b84-4400-8021-baacc4a92a7a 60681-7002 HUMAN OTC DRUG Pleo Cerivi Cetraria islandica subsp. islandica LIQUID ORAL 19980119 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CETRARIA ISLANDICA SUBSP. ISLANDICA 3 [hp_X]/2mL E 20171231 60681-8001_d5a59c42-6acf-44ed-b190-9d33566d9801 60681-8001 HUMAN OTC DRUG Pleo Citro citric acid monohydrate LIQUID ORAL 19970102 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CITRIC ACID MONOHYDRATE 200 [hp_X]/100mL E 20171231 60681-8002_19f4669b-95e2-4af2-a432-dc70ec39f10d 60681-8002 HUMAN OTC DRUG Pleo Citro citric acid LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG CITRIC ACID; CITRIC ACID; CITRIC ACID 10; 30; 200 [HP_X]/2mL; [HP_X]/2mL; [HP_X]/2mL E 20171231 60681-8003_58a6a1f3-3b43-487d-8f76-89c6baa50c0a 60681-8003 HUMAN OTC DRUG Pleo Citro CITRIC ACID MONOHYDRATE TABLET ORAL 20120710 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG CITRIC ACID MONOHYDRATE 200 [hp_X]/1 E 20171231 60681-9001_e6368c75-5aa2-4229-a7b9-9311e3dd8686 60681-9001 HUMAN OTC DRUG Pleo Ginkgo ginkgo biloba leaf SOLUTION/ DROPS ORAL 19961219 UNAPPROVED HOMEOPATHIC Sanum-Kehlbeck GmbH & Co. KG GINKGO BILOBA LEAF 1 [HP_X]/30mL E 20171231 60681-9002_2cfd2e4e-c605-4f81-86b0-5c579eb77b3e 60681-9002 HUMAN OTC DRUG Pleo Ginkgo GINKGO BILOBA LEAF LIQUID ORAL 19970319 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG GINKGO BILOBA LEAF 4 [hp_X]/2mL E 20171231 60681-9011_928bf3d1-cea6-499e-9fe5-a432c72940cc 60681-9011 HUMAN OTC DRUG Pleo Stroph strophanthus hispidus SOLUTION/ DROPS ORAL 20060221 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STROPHANTHUS HISPIDUS 4 [hp_X]/30mL E 20171231 60681-9012_7287da4b-e29d-4d1f-bf20-f1a8f08d2c67 60681-9012 HUMAN OTC DRUG Pleo Stroph strophanthus hispidus TABLET ORAL 20060221 UNAPPROVED HOMEOPATHIC Sanum Kehlbeck GmbH & Co. KG STROPHANTHUS HISPIDUS 4 [hp_X]/1 E 20171231 60683-106_a673ad81-f5d9-434c-b108-7eb00ce01489 60683-106 HUMAN OTC DRUG Rapid Comfort Aspirin Aspirin TABLET, FILM COATED ORAL 20111014 OTC MONOGRAPH FINAL part343 Lab Safety Supply, Inc. ASPIRIN 325 mg/1 N 20181231 60683-111_16707a48-a663-47b6-af96-c17116fbda3b 60683-111 HUMAN OTC DRUG Rapid Comfort Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20111014 OTC MONOGRAPH NOT FINAL part343 Lab Safety Supply, Inc. ACETAMINOPHEN 325 mg/1 E 20171231 60683-121_a82be2c1-4eec-4966-aa6e-68a9e4f87144 60683-121 HUMAN OTC DRUG Rapid Comfort Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20111014 OTC MONOGRAPH NOT FINAL part343 Lab Safety Supply, Inc. ACETAMINOPHEN 325 mg/1 E 20171231 60683-124_7b12d49a-cfa8-44b5-bfd1-0ef59ec4e0e9 60683-124 HUMAN OTC DRUG Rapid Comfort Extra Strength Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20111014 OTC MONOGRAPH NOT FINAL part343 Lab Safety Supply, Inc. ACETAMINOPHEN 500 mg/1 E 20171231 60683-129_6a98ed6e-10ba-4a18-b3b7-2fca334b4c82 60683-129 HUMAN OTC DRUG Rapid Comfort Extra Strength Non Aspirin Acetaminophen TABLET, FILM COATED ORAL 20111014 OTC MONOGRAPH NOT FINAL part343 Lab Safety Supply, Inc. ACETAMINOPHEN 500 mg/1 E 20171231 60687-100_55a3641a-a467-0a0e-e054-00144ff8d46c 60687-100 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20150501 ANDA ANDA079082 American Health Packaging URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 60687-103_5cc56d2b-1f67-be93-e053-2991aa0a94d9 60687-103 HUMAN PRESCRIPTION DRUG FAMCICLOVIR FAMCICLOVIR TABLET, FILM COATED ORAL 20150331 ANDA ANDA091480 American Health Packaging FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60687-105_55b1f3b7-7c85-3b2b-e054-00144ff88e88 60687-105 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20160405 ANDA ANDA040159 American Health Packaging MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 60687-108_559e378b-b664-1898-e054-00144ff8d46c 60687-108 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, COATED PELLETS ORAL 20151101 20180930 ANDA ANDA076575 American Health Packaging TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60687-109_559db667-45aa-6ed0-e054-00144ff8d46c 60687-109 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20151201 20181130 ANDA ANDA076470 American Health Packaging DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 60687-111_5b72357e-6c90-99f6-e053-2991aa0aab9c 60687-111 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20151102 ANDA ANDA091269 American Health Packaging LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 60687-112_63ff8862-9aeb-f709-e053-2a91aa0ad7dc 60687-112 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, COATED ORAL 20160115 ANDA ANDA078921 American Health Packaging ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20191231 60687-114_5d159398-fbc5-2e27-e053-2991aa0a105a 60687-114 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20150722 ANDA ANDA075113 American Health Packaging LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60687-115_5f4c9976-eb7e-04ce-e053-2a91aa0aa46f 60687-115 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20151020 20181130 ANDA ANDA040627 American Health Packaging BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 60687-116_60f28eb0-ca3c-3b5a-e053-2991aa0a3986 60687-116 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20160524 20181031 NDA AUTHORIZED GENERIC NDA200534 American Health Packaging OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60687-117_5cd716b7-86b1-2457-e053-2a91aa0a12cf 60687-117 HUMAN PRESCRIPTION DRUG Cevimeline Hydrochloride Cevimeline Hydrochloride CAPSULE ORAL 20150331 20181130 NDA NDA020989 American Health Packaging CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 60687-118_59793a84-738b-9199-e053-2a91aa0a533e 60687-118 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20150629 ANDA ANDA062031 American Health Packaging DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 60687-119_603ea1ae-baaf-474e-e053-2991aa0aa472 60687-119 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20150921 NDA AUTHORIZED GENERIC NDA020838 American Health Packaging CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60687-120_559db667-45aa-6ed0-e054-00144ff8d46c 60687-120 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20160201 20190228 ANDA ANDA076470 American Health Packaging DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 60687-121_6388ec15-5868-2b89-e053-2991aa0afb1c 60687-121 HUMAN PRESCRIPTION DRUG Acamprosate Calcium Acamprosate Calcium TABLET, DELAYED RELEASE ORAL 20150924 ANDA ANDA202229 American Health Packaging ACAMPROSATE CALCIUM 333 mg/1 N 20191231 60687-122_5a9527cb-9229-01e3-e053-2991aa0a9d54 60687-122 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20150814 ANDA ANDA040256 American Health Packaging PREDNISONE 5 mg/1 N 20181231 60687-123_5b72357e-6c90-99f6-e053-2991aa0aab9c 60687-123 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20160122 ANDA ANDA091269 American Health Packaging LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 60687-125_5d159398-fbc5-2e27-e053-2991aa0a105a 60687-125 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20151027 ANDA ANDA075113 American Health Packaging LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60687-127_580caef5-8061-36c8-e053-2991aa0ab5fa 60687-127 HUMAN PRESCRIPTION DRUG Omega-3-acid ethyl esters Omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20150605 ANDA ANDA090973 American Health Packaging OMEGA-3-ACID ETHYL ESTERS 1 g/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 60687-128_6362cf04-3d0f-fe5f-e053-2991aa0a8f9c 60687-128 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150215 ANDA ANDA202223 American Health Packaging VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 60687-129_589ecccb-9546-c4c6-e053-2991aa0a0f4b 60687-129 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20151101 OTC MONOGRAPH NOT FINAL part334 American Health Packaging DOCUSATE SODIUM 100 mg/1 N 20181231 60687-130_603ea1ae-baaf-474e-e053-2991aa0aa472 60687-130 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20151023 NDA AUTHORIZED GENERIC NDA020838 American Health Packaging CANDESARTAN CILEXETIL 32 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60687-134_5a9527cb-9229-01e3-e053-2991aa0a9d54 60687-134 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20150813 ANDA ANDA040256 American Health Packaging PREDNISONE 10 mg/1 N 20181231 60687-135_47f1d97c-4719-5c0d-e054-00144ff88e88 60687-135 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20151001 20180228 ANDA ANDA070976 American Health Packaging CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60687-136_5d159398-fbc5-2e27-e053-2991aa0a105a 60687-136 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20150930 ANDA ANDA075113 American Health Packaging LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60687-138_64775df6-9aab-4242-803e-cf613d0dc8ea 60687-138 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 20150901 ANDA ANDA080157 American Health Packaging PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] N 20181231 60687-139_6362cf04-3d0f-fe5f-e053-2991aa0a8f9c 60687-139 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150215 ANDA ANDA202223 American Health Packaging VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 60687-140_60f26bf5-e8aa-5979-e053-2a91aa0a9348 60687-140 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150803 20180831 ANDA ANDA077707 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 60687-141_455c6e09-ba7f-4099-e054-00144ff88e88 60687-141 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20150331 20180430 ANDA ANDA076137 American Health Packaging DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 60687-143_57e549a7-b102-e5b1-e053-2a91aa0aee56 60687-143 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20150907 ANDA ANDA203686 American Health Packaging METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60687-145_5a9527cb-9229-01e3-e053-2991aa0a9d54 60687-145 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20150917 ANDA ANDA040392 American Health Packaging PREDNISONE 20 mg/1 N 20181231 60687-148_59b06209-88f6-b67d-e053-2a91aa0a6369 60687-148 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20151201 20180930 NDA AUTHORIZED GENERIC NDA021611 American Health Packaging OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60687-149_5e6e1ffe-53f3-0824-e053-2991aa0a7d7f 60687-149 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20151001 ANDA ANDA091649 American Health Packaging CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 60687-150_5cdeec44-4019-6b73-e053-2a91aa0aa4ac 60687-150 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Extended-Release dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE ORAL 20151021 ANDA ANDA076353 American Health Packaging DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 60687-151_60f26bf5-e8aa-5979-e053-2a91aa0a9348 60687-151 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride (CD) Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20151023 20180831 ANDA ANDA077707 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 60687-152_5f4e8034-67a2-63d9-e053-2991aa0a685c 60687-152 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20151019 ANDA ANDA090836 American Health Packaging CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60687-155_57e549a7-b102-e5b1-e053-2a91aa0aee56 60687-155 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20160404 ANDA ANDA203686 American Health Packaging METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60687-156_5c89ce5f-ce9d-f957-e053-2991aa0aa9e4 60687-156 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin TABLET, CHEWABLE ORAL 20151123 ANDA ANDA200565 American Health Packaging PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 60687-157_5b362e9f-622d-cdbb-e053-2a91aa0a20ca 60687-157 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150605 ANDA ANDA205064 American Health Packaging ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 60687-158_5d071b41-275f-23bd-e053-2991aa0a4566 60687-158 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20160223 ANDA ANDA089776 American Health Packaging ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 60687-161_5b611c7b-e016-7c23-e053-2a91aa0a091c 60687-161 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20160307 ANDA ANDA077580 American Health Packaging HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 60687-162_57e549a7-b102-e5b1-e053-2a91aa0aee56 60687-162 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20151012 ANDA ANDA203686 American Health Packaging METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60687-163_5f4e8034-67a2-63d9-e053-2991aa0a685c 60687-163 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20151019 ANDA ANDA090836 American Health Packaging CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 60687-165_0d3eee18-c6d1-49f8-87a0-544d4f119c81 60687-165 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20150720 ANDA ANDA078317 American Health Packaging CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 60687-168_5b362e9f-622d-cdbb-e053-2a91aa0a20ca 60687-168 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150609 ANDA ANDA205064 American Health Packaging ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 60687-169_5fd98380-747e-4b4c-e053-2a91aa0ac047 60687-169 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20160725 ANDA ANDA077987 American Health Packaging PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60687-171_5918103a-5bb2-45b8-e053-2991aa0a246f 60687-171 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20150715 20190331 ANDA ANDA201146 American Health Packaging DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60687-173_c0b53008-c5b6-4eed-a544-535f68f8082c 60687-173 HUMAN PRESCRIPTION DRUG Memantine Memantine TABLET ORAL 20150815 ANDA ANDA090048 American Health Packaging MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 60687-176_62991165-ec64-48a8-e053-2991aa0a54f3 60687-176 HUMAN OTC DRUG ORGAN-I NR guaifenesin TABLET ORAL 20151028 20181231 OTC MONOGRAPH FINAL part341 American Health Packaging GUAIFENESIN 200 mg/1 N 20191231 60687-178_5fd98380-747e-4b4c-e053-2a91aa0ac047 60687-178 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20160707 ANDA ANDA077987 American Health Packaging PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60687-179_5b362e9f-622d-cdbb-e053-2a91aa0a20ca 60687-179 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150609 ANDA ANDA205064 American Health Packaging ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 60687-184_c0b53008-c5b6-4eed-a544-535f68f8082c 60687-184 HUMAN PRESCRIPTION DRUG Memantine Memantine TABLET ORAL 20150815 ANDA ANDA090048 American Health Packaging MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 60687-185_5f3a312a-c0c5-0205-e053-2991aa0afb61 60687-185 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160129 ANDA ANDA078540 American Health Packaging PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] N 20181231 60687-188_5e6be97b-40ee-b787-e053-2a91aa0a9660 60687-188 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20160620 ANDA ANDA203437 American Health Packaging ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 60687-189_2a2d24dd-ef17-6293-e054-00144ff8d46c 60687-189 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20160101 ANDA ANDA205517 American Health Packaging LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 60687-190_5fd98380-747e-4b4c-e053-2a91aa0ac047 60687-190 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20170215 ANDA ANDA077987 American Health Packaging PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60687-191_5b362e9f-622d-cdbb-e053-2a91aa0a20ca 60687-191 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150605 ANDA ANDA205064 American Health Packaging ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 60687-192_6067673e-f274-4757-e053-2991aa0a9364 60687-192 HUMAN PRESCRIPTION DRUG imatinib mesylate imatinib mesylate TABLET, FILM COATED ORAL 20160224 ANDA ANDA078340 American Health Packaging IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 60687-194_59180fe2-8453-347c-e053-2991aa0ad91f 60687-194 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 20160129 20180731 ANDA ANDA074903 American Health Packaging ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60687-195_603f56bf-7ada-9c16-e053-2a91aa0a1ea7 60687-195 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20161207 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 60687-195_64162651-4be8-4332-e053-2a91aa0ad3cb 60687-195 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20161116 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 60687-198_360b5c6e-c2dc-12e7-e054-00144ff88e88 60687-198 HUMAN PRESCRIPTION DRUG rifabutin rifabutin CAPSULE ORAL 20160701 ANDA ANDA090033 American Health Packaging RIFABUTIN 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 60687-199_603c1a0a-cbb1-0a7f-e053-2a91aa0ad150 60687-199 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20160531 ANDA ANDA077921 American Health Packaging MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60687-201_5fd98380-747e-4b4c-e053-2a91aa0ac047 60687-201 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20170215 ANDA ANDA077987 American Health Packaging PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60687-202_5b362e9f-622d-cdbb-e053-2a91aa0a20ca 60687-202 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150605 ANDA ANDA205064 American Health Packaging ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 60687-203_6067673e-f274-4757-e053-2991aa0a9364 60687-203 HUMAN PRESCRIPTION DRUG imatinib mesylate imatinib mesylate TABLET, FILM COATED ORAL 20160224 ANDA ANDA078340 American Health Packaging IMATINIB MESYLATE 400 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 60687-206_603f56bf-7ada-9c16-e053-2a91aa0a1ea7 60687-206 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20170123 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 60687-206_64162651-4be8-4332-e053-2a91aa0ad3cb 60687-206 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20170112 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 60687-209_5f9dcedd-a23c-bb1d-e053-2a91aa0a9d0c 60687-209 HUMAN PRESCRIPTION DRUG METHADOSE DISPERSIBLE Methadone Hydrochloride TABLET ORAL 20160719 ANDA ANDA074184 American Health Packaging METHADONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60687-210_33e88897-a887-4796-807a-500ca972f218 60687-210 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20160620 ANDA ANDA078103 American Health Packaging SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60687-211_4f1a3e73-f27c-72f8-e054-00144ff88e88 60687-211 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20160901 ANDA ANDA090554 American Health Packaging DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 60687-213_5b362e9f-622d-cdbb-e053-2a91aa0a20ca 60687-213 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150605 ANDA ANDA205064 American Health Packaging ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 60687-214_3f49b179-7001-5066-e054-00144ff88e88 60687-214 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20161201 ANDA ANDA203502 American Health Packaging METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60687-215_6360be05-80c8-4266-e053-2a91aa0a0195 60687-215 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170227 ANDA ANDA078703 American Health Packaging PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 60687-216_59c89153-e52b-2dc8-e053-2a91aa0a549c 60687-216 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET ORAL 20160815 ANDA ANDA206217 American Health Packaging ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 60687-217_603f56bf-7ada-9c16-e053-2a91aa0a1ea7 60687-217 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20170417 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 60687-217_64162651-4be8-4332-e053-2a91aa0ad3cb 60687-217 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20170321 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 60687-221_6313b52a-97cb-db70-e053-2991aa0ae813 60687-221 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE ORAL 20170103 20180531 ANDA ANDA076852 American Health Packaging DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 60687-224_603c88e9-529d-7164-e053-2991aa0a738b 60687-224 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20160808 ANDA ANDA077836 American Health Packaging GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 60687-225_3a45e443-906f-1939-e054-00144ff8d46c 60687-225 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20160808 ANDA ANDA075442 American Health Packaging FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] N 20181231 60687-226_6360be05-80c8-4266-e053-2a91aa0a0195 60687-226 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170713 ANDA ANDA078703 American Health Packaging PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 60687-227_4d70569e-9577-5109-e054-00144ff8d46c 60687-227 HUMAN PRESCRIPTION DRUG Leucovorin Calcium Leucovorin Calcium TABLET ORAL 20161001 ANDA ANDA071199 American Health Packaging LEUCOVORIN CALCIUM 25 mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 60687-228_603f56bf-7ada-9c16-e053-2a91aa0a1ea7 60687-228 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20170810 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 60687-228_64162651-4be8-4332-e053-2a91aa0ad3cb 60687-228 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20170720 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 60687-229_635df752-ec36-1c23-e053-2991aa0a8f5e 60687-229 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20170109 ANDA ANDA073192 American Health Packaging LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20191231 60687-230_609f9137-0b09-6c76-e053-2a91aa0affd5 60687-230 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20161201 ANDA ANDA077869 American Health Packaging ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 60687-231_604e8fe0-f169-6e9b-e053-2991aa0adfeb 60687-231 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20170124 ANDA ANDA077397 American Health Packaging SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 60687-232_6313b52a-97cb-db70-e053-2991aa0ae813 60687-232 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE ORAL 20161227 20180531 ANDA ANDA076852 American Health Packaging DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 60687-234_60276eec-69f0-71f5-e053-2a91aa0af483 60687-234 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA079170 American Health Packaging ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60687-235_4ab5baee-9662-6a31-e054-00144ff88e88 60687-235 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20170315 ANDA ANDA078279 American Health Packaging ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60687-237_6360be05-80c8-4266-e053-2a91aa0a0195 60687-237 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170224 20181031 ANDA ANDA078703 American Health Packaging PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 60687-241_603ea1ae-baaf-474e-e053-2991aa0aa472 60687-241 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20161007 NDA AUTHORIZED GENERIC NDA020838 American Health Packaging CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60687-242_604e8fe0-f169-6e9b-e053-2991aa0adfeb 60687-242 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20161205 ANDA ANDA077397 American Health Packaging SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 60687-245_60276eec-69f0-71f5-e053-2a91aa0af483 60687-245 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160926 ANDA ANDA079170 American Health Packaging ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60687-246_4ab5baee-9662-6a31-e054-00144ff88e88 60687-246 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20170315 ANDA ANDA078279 American Health Packaging ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60687-249_63b2e396-0e8f-459d-e053-2a91aa0a5b30 60687-249 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20171027 ANDA ANDA203052 American Health Packaging LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 60687-253_604e8fe0-f169-6e9b-e053-2991aa0adfeb 60687-253 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20170403 ANDA ANDA077397 American Health Packaging SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 60687-256_60276eec-69f0-71f5-e053-2a91aa0af483 60687-256 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160921 ANDA ANDA079170 American Health Packaging ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60687-258_6414f1d7-4cff-7504-e053-2991aa0a8972 60687-258 HUMAN PRESCRIPTION DRUG Theophylline Theophylline SOLUTION ORAL 20171107 ANDA ANDA091156 American Health Packaging THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20191231 60687-260_64150aca-964c-93cd-e053-2a91aa0a837d 60687-260 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine Hydrochloride SOLUTION ORAL 20171107 ANDA ANDA091288 American Health Packaging RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 60687-263_63883fcc-9112-250a-e053-2a91aa0a4bd4 60687-263 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20161219 ANDA ANDA077955 American Health Packaging AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 60687-264_629902ec-e3f5-7ff4-e053-2a91aa0a9dde 60687-264 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine TABLET, DELAYED RELEASE ORAL 20161118 20190228 NDA AUTHORIZED GENERIC NDA021830 American Health Packaging MESALAMINE 800 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20191231 60687-265_4e252c92-e7e5-383e-e054-00144ff8d46c 60687-265 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20170123 ANDA ANDA075520 American Health Packaging NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60687-266_42fda6e5-c74b-1e07-e054-00144ff8d46c 60687-266 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene TABLET ORAL 20161121 ANDA ANDA090842 American Health Packaging RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 60687-268_62eb8108-f716-3811-e053-2991aa0a9104 60687-268 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20170117 ANDA ANDA091305 American Health Packaging NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 60687-269_4e252c92-e7c2-383e-e054-00144ff8d46c 60687-269 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161201 ANDA ANDA077899 American Health Packaging NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60687-270_4c07c316-2b29-42ec-e054-00144ff8d46c 60687-270 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20170315 ANDA ANDA040653 American Health Packaging GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 60687-271_6326f85b-2c9d-7416-e053-2991aa0ab43d 60687-271 HUMAN PRESCRIPTION DRUG Azithromycin Monohydrate Azithromycin Monohydrate TABLET ORAL 20170124 ANDA ANDA065399 American Health Packaging AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 60687-273_5070440e-40a4-44f3-e054-00144ff88e88 60687-273 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20170501 ANDA ANDA203503 American Health Packaging VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 60687-274_63883fcc-9112-250a-e053-2a91aa0a4bd4 60687-274 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20161118 ANDA ANDA077955 American Health Packaging AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 60687-276_6313b52a-97cb-db70-e053-2991aa0ae813 60687-276 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE ORAL 20170203 20181231 ANDA ANDA076852 American Health Packaging DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 60687-280_4e252c92-e7c2-383e-e054-00144ff8d46c 60687-280 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170215 ANDA ANDA077899 American Health Packaging NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60687-281_4e252c92-e7e5-383e-e054-00144ff8d46c 60687-281 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20170501 ANDA ANDA075520 American Health Packaging NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60687-282_6326f85b-2c9d-7416-e053-2991aa0ab43d 60687-282 HUMAN PRESCRIPTION DRUG Azithromycin Monohydrate Azithromycin Monohydrate TABLET ORAL 20170213 ANDA ANDA065398 American Health Packaging AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 60687-284_637811a5-8e97-1cf6-e053-2a91aa0a0471 60687-284 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20170126 ANDA ANDA078560 American Health Packaging EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20191231 60687-285_63883fcc-9112-250a-e053-2a91aa0a4bd4 60687-285 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20170206 ANDA ANDA077955 American Health Packaging AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 60687-286_5263d7c1-60eb-0416-e054-00144ff8d46c 60687-286 HUMAN PRESCRIPTION DRUG Bromocriptine Mesylate Bromocriptine Mesylate TABLET ORAL 20170601 ANDA ANDA074631 American Health Packaging BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 60687-287_6313b52a-97cb-db70-e053-2991aa0ae813 60687-287 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE ORAL 20170113 20180630 ANDA ANDA076852 American Health Packaging DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 60687-291_4e252c92-e7c2-383e-e054-00144ff8d46c 60687-291 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170501 ANDA ANDA077899 American Health Packaging NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60687-292_4a9de30f-32a7-440b-e054-00144ff8d46c 60687-292 HUMAN PRESCRIPTION DRUG Donepezil Donepezil hydrochloride TABLET ORAL 20170201 ANDA ANDA203034 American Health Packaging DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60687-293_4e252c92-e7e5-383e-e054-00144ff8d46c 60687-293 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20170501 ANDA ANDA075520 American Health Packaging NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60687-294_5070440e-40a4-44f3-e054-00144ff88e88 60687-294 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20170501 ANDA ANDA203503 American Health Packaging VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 60687-295_5438d961-e2d4-0c65-e054-00144ff8d46c 60687-295 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20170715 ANDA ANDA070177 American Health Packaging PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60687-298_6313b52a-97cb-db70-e053-2991aa0ae813 60687-298 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE ORAL 20170113 20180630 ANDA ANDA076852 American Health Packaging DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 60687-299_4c07c316-2b1a-42ec-e054-00144ff8d46c 60687-299 HUMAN PRESCRIPTION DRUG Itraconazole Itraconazole CAPSULE ORAL 20170401 ANDA ANDA205080 American Health Packaging ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 60687-302_4d118707-5ad7-5806-e054-00144ff8d46c 60687-302 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20170415 ANDA ANDA203455 American Health Packaging NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60687-303_4a9de30f-32a7-440b-e054-00144ff8d46c 60687-303 HUMAN PRESCRIPTION DRUG Donepezil Donepezil hydrochloride TABLET ORAL 20170201 ANDA ANDA203034 American Health Packaging DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 60687-304_6389959c-4494-d257-e053-2a91aa0a2ed6 60687-304 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20171117 ANDA ANDA074505 American Health Packaging CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 60687-305_5a2b5034-886c-b295-e053-2a91aa0a71c1 60687-305 HUMAN PRESCRIPTION DRUG Aspirin and Extended-Release Dipyridamole Aspirin and Extended-Release Dipyridamole CAPSULE ORAL 20171001 ANDA ANDA206392 American Health Packaging ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 60687-306_5438d961-e2d4-0c65-e054-00144ff8d46c 60687-306 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20170715 ANDA ANDA070176 American Health Packaging PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60687-308_647913b8-2431-2774-e053-2991aa0a227c 60687-308 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone Hydrochloride TABLET ORAL 20170427 ANDA ANDA074253 American Health Packaging BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20191231 60687-309_5a050880-e426-4d54-e053-2991aa0a6da6 60687-309 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20171001 ANDA ANDA204239 American Health Packaging LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 60687-310_5e6ec98a-989a-138f-e053-2991aa0a77e1 60687-310 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20171127 ANDA ANDA202128 American Health Packaging POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 60687-311_5f0d9e2d-fc6f-aadd-e053-2a91aa0a6ae7 60687-311 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20171201 ANDA ANDA078115 American Health Packaging CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 60687-312_643d973c-3561-535b-e053-2991aa0a41cb 60687-312 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170412 ANDA ANDA077284 American Health Packaging BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 60687-313_4d118707-5ad7-5806-e054-00144ff8d46c 60687-313 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20170415 ANDA ANDA203455 American Health Packaging NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60687-314_5290a721-8502-29ef-e054-00144ff8d46c 60687-314 HUMAN PRESCRIPTION DRUG Azithromycin Monohydrate Azithromycin Monohydrate TABLET ORAL 20170701 ANDA ANDA065400 American Health Packaging AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 60687-315_6389959c-4494-d257-e053-2a91aa0a2ed6 60687-315 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20171117 ANDA ANDA074505 American Health Packaging CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 60687-316_62d81aea-4111-7313-e053-2991aa0af2e0 60687-316 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20180115 ANDA ANDA073652 American Health Packaging NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20191231 60687-317_55d92417-311b-1cfb-e054-00144ff8d46c 60687-317 HUMAN PRESCRIPTION DRUG Chlorthalidone Chlorthalidone TABLET ORAL 20170801 ANDA ANDA089286 American Health Packaging CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 60687-319_5420182b-bc6d-5828-e054-00144ff8d46c 60687-319 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine CAPSULE, EXTENDED RELEASE ORAL 20170715 ANDA ANDA203016 American Health Packaging TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 60687-320_60f2996b-1ffc-543d-e053-2991aa0a98d5 60687-320 HUMAN PRESCRIPTION DRUG Colchicine Colchicine TABLET, FILM COATED ORAL 20170713 20181231 NDA AUTHORIZED GENERIC NDA022352 American Health Packaging COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20181231 60687-321_57d4b372-320b-850b-e053-2991aa0a50f3 60687-321 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20170901 ANDA ANDA078832 American Health Packaging RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60687-322_55d95cfa-81df-25ca-e054-00144ff8d46c 60687-322 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20170801 ANDA ANDA077824 American Health Packaging RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 60687-324_4d118707-5ad7-5806-e054-00144ff8d46c 60687-324 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20170415 ANDA ANDA203455 American Health Packaging NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60687-325_60ddcd04-901f-48b5-e053-2a91aa0a9f3f 60687-325 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20180102 ANDA ANDA077321 American Health Packaging LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60687-326_55b2dcd2-e1fe-1c82-e054-00144ff8d46c 60687-326 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170801 ANDA ANDA079016 American Health Packaging ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60687-327_57d659cd-76be-7b3e-e053-2991aa0a162d 60687-327 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine TABLET ORAL 20170901 ANDA ANDA201109 American Health Packaging QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 60687-328_5748ea58-61a3-a0eb-e053-2a91aa0a9624 60687-328 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate Sevelamer Carbonate TABLET, FILM COATED ORAL 20170816 ANDA ANDA207179 American Health Packaging SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 60687-330_5420182b-bc6d-5828-e054-00144ff8d46c 60687-330 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine CAPSULE, EXTENDED RELEASE ORAL 20170715 ANDA ANDA203016 American Health Packaging TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 60687-332_57d4b372-320b-850b-e053-2991aa0a50f3 60687-332 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20170901 ANDA ANDA078832 American Health Packaging RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60687-333_60ddcd04-901f-48b5-e053-2a91aa0a9f3f 60687-333 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20180102 ANDA ANDA077321 American Health Packaging LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60687-335_5f0d9e2d-fc6f-aadd-e053-2a91aa0a6ae7 60687-335 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20171201 ANDA ANDA078115 American Health Packaging CARBAMAZEPINE 400 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 60687-336_62d7efff-377e-711a-e053-2a91aa0a3f5e 60687-336 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20180115 ANDA ANDA065062 American Health Packaging MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 60687-338_57d659cd-76be-7b3e-e053-2991aa0a162d 60687-338 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine TABLET ORAL 20170901 ANDA ANDA201109 American Health Packaging QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 60687-340_60dda492-0887-fd65-e053-2991aa0ada4c 60687-340 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20171215 ANDA ANDA076143 American Health Packaging BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60687-343_57d4b372-320b-850b-e053-2991aa0a50f3 60687-343 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20170901 ANDA ANDA078832 American Health Packaging RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60687-344_5bd7d4b1-7ab6-10c7-e053-2a91aa0a2a83 60687-344 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20171101 ANDA ANDA065285 American Health Packaging DOXYCYCLINE 100 mg/1 N 20181231 60687-346_6156acdb-898d-072c-e053-2991aa0a4c87 60687-346 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20171226 ANDA ANDA040627 American Health Packaging BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 60687-347_6244e19a-9b57-2d09-e053-2a91aa0a1271 60687-347 HUMAN PRESCRIPTION DRUG mesalamine mesalamine TABLET, DELAYED RELEASE ORAL 20180102 NDA AUTHORIZED GENERIC NDA021830 American Health Packaging MESALAMINE 800 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20191231 60687-349_57d659cd-76be-7b3e-e053-2991aa0a162d 60687-349 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine TABLET ORAL 20170901 ANDA ANDA201109 American Health Packaging QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 60687-351_60dda492-0887-fd65-e053-2991aa0ada4c 60687-351 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20180102 ANDA ANDA076143 American Health Packaging BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60687-352_62e813c5-ae39-56db-e053-2a91aa0a1e7c 60687-352 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20180115 ANDA ANDA204652 American Health Packaging FLUCYTOSINE 250 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20191231 60687-354_57d4b372-320b-850b-e053-2991aa0a50f3 60687-354 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20170901 ANDA ANDA078832 American Health Packaging RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60687-360_57d659cd-76be-7b3e-e053-2991aa0a162d 60687-360 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine TABLET ORAL 20170901 ANDA ANDA201109 American Health Packaging QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 60687-363_62e813c5-ae39-56db-e053-2a91aa0a1e7c 60687-363 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20180115 ANDA ANDA204652 American Health Packaging FLUCYTOSINE 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20191231 60687-371_57d659cd-76be-7b3e-e053-2991aa0a162d 60687-371 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine TABLET ORAL 20170901 ANDA ANDA201109 American Health Packaging QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 60687-382_57d659cd-76be-7b3e-e053-2991aa0a162d 60687-382 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine TABLET ORAL 20170901 ANDA ANDA201109 American Health Packaging QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 60687-393_5cddbfb3-f099-1c02-e053-2991aa0a7cd4 60687-393 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20171101 ANDA ANDA201109 American Health Packaging QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 60691-114_92907e2a-bd56-4f22-91c7-801f26ca4905 60691-114 HUMAN OTC DRUG MIRACLE ICE Arthritis Pain Reliever Menthol and Camphor (synthetic) GEL TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part348 FDN Enterprises, LLC MENTHOL; CAMPHOR (SYNTHETIC) 1; .5 g/100g; g/100g E 20171231 60691-115_dc4844de-e386-4040-8b1c-9097fa7270c9 60691-115 HUMAN OTC DRUG MIRACLE ICE Menthol and Camphor (synthetic) GEL TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part348 FDN Enterprises, LLC MENTHOL; CAMPHOR (SYNTHETIC) 1; .5 g/100g; g/100g E 20171231 60691-116_10137856-eae0-45b1-bf9a-1412c8775a5b 60691-116 HUMAN OTC DRUG Miracle Ice Ultra Strength Menthol and Camphor (synthetic) GEL TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part348 FDN Enterprises,LLC MENTHOL; CAMPHOR (SYNTHETIC) 1; .5 g/100g; g/100g E 20171231 60691-117_9f93e6b6-0a51-4039-b217-daae7b62e9f9 60691-117 HUMAN OTC DRUG Miracle Ice Therapeutic Menthol and Camphor (synthetic) GEL TOPICAL 20130715 OTC MONOGRAPH NOT FINAL part348 FDN Enterprises, LLC MENTHOL; CAMPHOR (SYNTHETIC) 1; .5 g/100g; g/100g E 20171231 60691-123_2fd41533-9341-4f3a-ab97-4326adfb98a8 60691-123 HUMAN OTC DRUG Classic Care Baby Petrolatum JELLY TOPICAL 20110530 OTC MONOGRAPH FINAL part347 FDN Enterprises, LLC PETROLATUM 998 mg/g E 20171231 60691-124_21ce8420-dc91-48d7-a361-a8d8d64bd224 60691-124 HUMAN OTC DRUG Classic Care Apricot Scrub Blemish Control Salicylic Acid CREAM TOPICAL 20120926 OTC MONOGRAPH FINAL part333D FDN Enterprises, LLC SALICYLIC ACID 2 g/100g E 20171231 60691-126_dcb5e20d-53f0-4ee9-9f5e-45c656cf3daf 60691-126 HUMAN OTC DRUG Classic Care Petroleum Petrolatum JELLY TOPICAL 20110530 OTC MONOGRAPH FINAL part347 FDN Enterprises, LLC PETROLATUM 100 g/100g E 20171231 60694-1901_60f2fba6-8e6e-102b-e053-2a91aa0ac82b 60694-1901 HUMAN PRESCRIPTION DRUG Lipiodol Ultra-Fluide Ethiodized Oil INJECTION INTRA-ARTERIAL; INTRALYMPHATIC; INTRAMUSCULAR 20150601 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Delpharm Tours ETHIODIZED OIL 480 mg/mL N 20181231 60696-1234_9b371bac-a2fd-40da-a08a-00e4871ec430 60696-1234 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 NDA NDA205820 Kalispell Medical Equipment OXYGEN 99 L/100L N 20181231 60698-0000_2a86514f-5a45-4180-b6d2-36206b7cbe21 60698-0000 HUMAN OTC DRUG Notaflu Lemon Oil LEMON OIL SPRAY NASAL 20130916 UNAPPROVED HOMEOPATHIC RC InnPharma Corporation LEMON OIL 1 [hp_X]/30mL E 20171231 60698-0001_aee671c5-9b19-4de9-a2fb-ca4b45409273 60698-0001 HUMAN OTC DRUG Notaflu Lemon Oil LEMON OIL SPRAY ORAL 20130916 UNAPPROVED HOMEOPATHIC RC InnPharma Corporation LEMON OIL 1 [hp_X]/30mL E 20171231 60709-100_dae2223b-f850-4bdb-a68b-f38b76954b8b 60709-100 HUMAN OTC DRUG NANO PPC NANO PPC CREAM TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part343 YBK Investment, INC CAFFEINE 5 mg/1000mL E 20171231 60709-101_d3fe3a8f-ccc1-4478-97d8-68a9ea0315d9 60709-101 HUMAN OTC DRUG Skin Delight Mask Pack Plus Mask Pack PATCH TOPICAL 20131021 UNAPPROVED DRUG OTHER YBK Investment, INC PREZATIDE COPPER .22 mg/22g E 20171231 60709-102_04af745b-a80d-4d4a-8942-ee35f236a82f 60709-102 HUMAN OTC DRUG Cosmeceutical Mask Pack Mask Pack PATCH TOPICAL 20131021 UNAPPROVED DRUG OTHER YBK Investment, INC PREZATIDE COPPER; PALMITOYL OLIGOPEPTIDE; NEPIDERMIN; MECASERMIN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); THIOREDOXIN .22; .044; .044; .044; .044; .044 mg/22g; mg/22g; mg/22g; mg/22g; mg/22g; mg/22g E 20171231 60709-105_33cc0c1b-0f86-4e00-a346-44e8effaabbc 60709-105 HUMAN OTC DRUG Dermaheal Cosmeceutical Mask Pack Plus Copper Tripeptide-1 (0.001%) PATCH TOPICAL 20131021 UNAPPROVED DRUG OTHER YBK Investment, INC PREZATIDE COPPER; PALMITOYL OLIGOPEPTIDE; NEPIDERMIN; MECASERMIN; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); THIOREDOXIN .22; .044; .044; .044; .044; .044 mg/22g; mg/22g; mg/22g; mg/22g; mg/22g; mg/22g E 20171231 60709-106_91f9fa8d-7bce-4ba2-8764-defa0e0dcb43 60709-106 HUMAN OTC DRUG Dermaheal Skin Delight Mask Pack Plus Copper Tripeptide-1 (0.001%) PATCH TOPICAL 20131021 UNAPPROVED DRUG OTHER YBK Investment, INC PREZATIDE COPPER .22 mg/22g E 20171231 60709-107_f1811ea6-640d-40bf-ae08-05d9e9d476ad 60709-107 HUMAN OTC DRUG NANO PPC Caffeine CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part343 YBK Investment, INC VANILLYL BUTYL ETHER; CAFFEINE 2.5; 1.25 mg/250mL; mg/250mL E 20171231 60710-2320_02c817dd-1c13-4f8a-8bc0-56be0e39dfa9 60710-2320 HUMAN PRESCRIPTION DRUG ZINC INJECTABLE A 1mg/ml, solution injectable pour perfusion Zinc INJECTION, SOLUTION INTRAVENOUS 20131001 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Laboratoire Aguettant ZINC GLUCONATE TRIHYDRATE 1 mg/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] E 20171231 60716-010_46ebe6bd-9823-44b7-854b-7e949834c69f 60716-010 HUMAN OTC DRUG RENOKIN HAIR REVITALIZING Allantoin SHAMPOO TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Caregen Co., Ltd. ALLANTOIN .75 mg/150mL N 20181231 60716-020_0c747cda-4b74-4739-a399-5eb788a656d4 60716-020 HUMAN OTC DRUG RENOKIN HAIR REVITALIZING CONDITIONER Dimethicone LIQUID TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Caregen Co., Ltd. DIMETHICONE 1.1 mg/110mL N 20181231 60716-030_22565595-f3f1-4b40-b8cb-cdf58deaedfa 60716-030 HUMAN OTC DRUG RENOKIN HAIR REVITALIZING Allantoin SOLUTION TOPICAL 20140102 OTC MONOGRAPH FINAL part347 Caregen Co., Ltd. ALLANTOIN .3 mg/60mL N 20181231 60716-040_e1e74c73-2df9-4296-95ca-e055716b2c38 60716-040 HUMAN OTC DRUG RENOKIN LASH LASH Allantoin LIQUID TOPICAL 20140307 OTC MONOGRAPH FINAL part347 Caregen Co., Ltd. ALLANTOIN .025 mg/5mL N 20181231 60716-050_337e6642-b1ba-43f1-8771-27b14d4935c9 60716-050 HUMAN OTC DRUG Pelo Baum Hair Revitalizing Allantoin SHAMPOO TOPICAL 20170501 OTC MONOGRAPH FINAL part347 Caregen Co.,Ltd. ALLANTOIN .75 g/150mL N 20181231 60716-060_651cb6fd-2f5c-40c1-9e68-a23773023b1c 60716-060 HUMAN OTC DRUG Pelo Baum Hair Revitalizing Allantoin SOLUTION TOPICAL 20170501 OTC MONOGRAPH FINAL part347 Caregen Co.,Ltd. ALLANTOIN .3 g/60mL N 20181231 60716-070_a2a11d3a-b327-4c7f-8320-32eadce8c000 60716-070 HUMAN OTC DRUG Pelo Baum Hair Revitalizing Conditioner Dimethicone LIQUID TOPICAL 20170501 OTC MONOGRAPH FINAL part347 Caregen Co.,Ltd. DIMETHICONE 1.1 g/110mL N 20181231 60716-080_1bfaef01-6f4c-4e58-b2a6-bd85167c290b 60716-080 HUMAN OTC DRUG Pelo Baum Brow Brow Allantoin LIQUID TOPICAL 20170601 OTC MONOGRAPH FINAL part347 Caregen Co.,Ltd. ALLANTOIN .05 g/10mL N 20181231 60716-090_ddb5f3ee-3d45-4526-a9bd-e318fc64da95 60716-090 HUMAN OTC DRUG Pelo Baum Lash Lash Allantoin LIQUID TOPICAL 20170601 OTC MONOGRAPH FINAL part347 Caregen Co.,Ltd. ALLANTOIN .025 g/5mL N 20181231 60717-001_188c333e-8fc8-4838-9555-ab34df9372a8 60717-001 HUMAN OTC DRUG HAND SANITIZER with ALOE VERA ALCOHOL LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333E RNA PHARMA LLC ALCOHOL 65 mL/mL E 20171231 60723-004_24533fda-78e7-0586-e054-00144ff88e88 60723-004 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20151130 ANDA ANDA205695 Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 60723-005_24533fda-78e7-0586-e054-00144ff88e88 60723-005 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20151130 ANDA ANDA205695 Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 60723-010_2eb05d50-76ac-5ca6-e054-00144ff88e88 60723-010 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20160530 ANDA ANDA205683 Hangzhou Minsheng Binjiang Pharm MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 60723-031_c77553bd-03a7-4c23-b80a-477517394eeb 60723-031 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, COATED ORAL 20131231 ANDA ANDA203590 Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 60723-032_c77553bd-03a7-4c23-b80a-477517394eeb 60723-032 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, COATED ORAL 20131231 ANDA ANDA203590 Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 60723-033_c77553bd-03a7-4c23-b80a-477517394eeb 60723-033 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, COATED ORAL 20131231 ANDA ANDA203590 Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 60723-205_5fbd4b53-61db-0c14-e053-2a91aa0aeee8 60723-205 HUMAN PRESCRIPTION DRUG Alendronate ALENDRONATE SODIUM TABLET ORAL 20171205 ANDA ANDA090258 Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20191231 60723-207_5fbd4b53-61db-0c14-e053-2a91aa0aeee8 60723-207 HUMAN PRESCRIPTION DRUG Alendronate ALENDRONATE SODIUM TABLET ORAL 20171205 ANDA ANDA090258 Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20191231 60724-101_67ff6112-769d-4b0f-919a-0a56e476fdd7 60724-101 HUMAN OTC DRUG BEING TRUE ESSENTIALS ABSOLUTELY RADIANT OCTISALATE, HOMOSALATE, AVOBENZONE AND OCTOCRYLENE LOTION TOPICAL 20130919 OTC MONOGRAPH FINAL part352 TRUE Cosmetics LLC OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE 5; 5; 3; 2.7 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 60742-001_446a696f-296f-45e3-abd2-d87b5d6e47e8 60742-001 HUMAN OTC DRUG One Step Hand Sanitizer Aloe ALCOHOL GEL TOPICAL 20120131 OTC MONOGRAPH NOT FINAL part356 BELVEDERE INTERNATIONAL INC. ALCOHOL 62 mL/100mL E 20171231 60742-002_9152d5e7-8ca5-4df6-99da-8fb47aa62941 60742-002 HUMAN OTC DRUG DG Deep Cleaning Astringent Sensitive Skin SALICYLIC ACID LIQUID TOPICAL 20130131 OTC MONOGRAPH NOT FINAL part333D BELVEDERE INTERNATIONAL INC. SALICYLIC ACID .5 g/100g N 20181231 60742-003_e6764a82-dea7-4ca7-8be3-0568ae2df957 60742-003 HUMAN OTC DRUG LIVE CLEAN BABY ZINC OXIDE CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part346 BELVEDERE INTERNATIONAL INC. ZINC OXIDE 15 g/100g N 20181231 60742-004_b7064a65-267a-4ff4-8969-3d91076c64a9 60742-004 HUMAN OTC DRUG LIVE CLEAN BABY 2% COLLOIDAL OATMEAL SHAMPOO TOPICAL 20170720 OTC MONOGRAPH FINAL part347 BELVEDERE INTERNATIONAL INC. OATMEAL 2 g/100g N 20181231 60742-005_e1eaca0d-e22e-499f-89fc-e4802bd11a8e 60742-005 HUMAN OTC DRUG LIVE CLEAN BABY 2% COLLOIDAL OATMEAL CREAM TOPICAL 20170720 OTC MONOGRAPH FINAL part347 BELVEDERE INTERNATIONAL INC. OATMEAL 2 g/100g N 20181231 60742-006_3bcbc1da-9a66-4284-901c-a13ef004ce66 60742-006 HUMAN OTC DRUG EQUATE HAND SANITIZER 70% ALCOHOL SANITIZER GEL TOPICAL 20171122 OTC MONOGRAPH NOT FINAL part333E BELVEDERE INTERNATIONAL INC. ALCOHOL 70 mL/100mL N 20181231 60742-175_19114c5f-d78d-4787-80e4-fc550b261221 60742-175 HUMAN OTC DRUG One Step Sanitizer ALCOHOL SPRAY TOPICAL 20120209 OTC MONOGRAPH NOT FINAL part356 Belvedere International Inc. ALCOHOL 62 mL/100mL E 20171231 60742-200_20ee27be-928d-4aed-a470-8d7120b562e1 60742-200 HUMAN OTC DRUG One Step Wipes ALCOHOL LIQUID TOPICAL 20120131 OTC MONOGRAPH NOT FINAL part356 BELVEDERE INTERNATIONAL INC. ALCOHOL 62 mL/100mL N 20181231 60742-473_7e061051-8dec-42b1-8b3c-390875b8cab4 60742-473 HUMAN OTC DRUG One Step Hand Sanitizer ALCOHOL GEL TOPICAL 20120127 OTC MONOGRAPH NOT FINAL part356 Belvedere International Inc. ALCOHOL 62 mL/100mL E 20171231 60758-018_e38b202b-fab9-4f73-9b06-c268e4bebece 60758-018 HUMAN PRESCRIPTION DRUG sulfacetamide sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 20150206 ANDA ANDA080028 Pacific Pharma SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 60758-060_38236b7a-00c6-4772-a624-db36950baa98 60758-060 HUMAN PRESCRIPTION DRUG LEVOBUNOLOL HYDROCHLORIDE levobunolol hydrochloride SOLUTION/ DROPS OPHTHALMIC 19970715 NDA AUTHORIZED GENERIC NDA019219 Pacific Pharma, Inc. LEVOBUNOLOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60758-119_ff5902c9-1bc8-4df9-b938-524ee1293b58 60758-119 HUMAN PRESCRIPTION DRUG PREDNISOLONE ACETATE prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19970819 NDA AUTHORIZED GENERIC NDA017011 Pacific Pharma, Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60758-188_a5b6ce7b-63ea-466b-96cf-70caf394dd82 60758-188 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 19980105 ANDA ANDA062452 Pacific Pharma, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 60758-556_aaf24279-0465-4371-b23b-3e4636a20801 60758-556 HUMAN PRESCRIPTION DRUG Tazarotene Tazarotene CREAM TOPICAL 20170415 NDA NDA021184 Pacific Pharma, Inc. TAZAROTENE .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 60758-561_aaf24279-0465-4371-b23b-3e4636a20801 60758-561 HUMAN PRESCRIPTION DRUG Tazarotene Tazarotene CREAM TOPICAL 20170415 NDA NDA021184 Pacific Pharma, Inc. TAZAROTENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 60758-615_29879d31-f38f-40a7-8c31-b451e17138c7 60758-615 HUMAN PRESCRIPTION DRUG gatifloxacin gatifloxacin SOLUTION/ DROPS OPHTHALMIC 20150415 NDA AUTHORIZED GENERIC NDA022548 Pacific Pharma GATIFLOXACIN 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 60758-670_f5f79832-62c0-4eb2-ad5b-d4796f04df3c 60758-670 HUMAN PRESCRIPTION DRUG DAPSONE dapsone GEL TOPICAL 20171018 NDA NDA021794 Pacific Pharma DAPSONE 50 mg/g Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 60758-773_781694ed-2f9c-442d-b593-6f36fc35642f 60758-773 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE Ketorolac Tromethamine SOLUTION/ DROPS OPHTHALMIC 20131121 NDA AUTHORIZED GENERIC NDA021528 Pacific Pharma, Inc. KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 60758-801_8d072f4d-cbb5-4b4d-a8ca-130124f3ee8f 60758-801 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 19970520 ANDA ANDA074747 Pacific Pharma, Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60758-802_8d072f4d-cbb5-4b4d-a8ca-130124f3ee8f 60758-802 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 19970520 ANDA ANDA074746 Pacific Pharma, Inc. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60758-880_3fef0b80-47db-4a88-83c4-54c4b4f25708 60758-880 HUMAN PRESCRIPTION DRUG FLUOROMETHOLONE fluorometholone SOLUTION/ DROPS OPHTHALMIC 19971031 NDA AUTHORIZED GENERIC NDA016851 Pacific Pharma, Inc. FLUOROMETHOLONE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 60758-908_b5f8b8f5-2619-4b05-b801-341ec74f4068 60758-908 HUMAN PRESCRIPTION DRUG POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate SOLUTION/ DROPS OPHTHALMIC 19970429 NDA AUTHORIZED GENERIC NDA050567 Pacific Pharma, Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 60758-910_406799d2-720a-4cee-abfd-6db127874880 60758-910 HUMAN PRESCRIPTION DRUG FLURBIPROFEN SODIUM flurbiprofen sodium SOLUTION/ DROPS OPHTHALMIC 19970529 NDA AUTHORIZED GENERIC NDA019404 Pacific Pharma, Inc. FLURBIPROFEN SODIUM .3 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-002_60b97d09-6bbc-cc01-e053-2991aa0a5908 60760-002 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20151113 ANDA ANDA040362 St. Mary's Medical Park Pharmacy PREDNISONE 20 mg/1 N 20191231 60760-005_5fc8947f-3d6b-be6a-e053-2a91aa0a6b47 60760-005 HUMAN PRESCRIPTION DRUG SIMVASTATIN simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 St Marys Medical Park Pharmacy SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60760-006_5fc8947f-3d6b-be6a-e053-2a91aa0a6b47 60760-006 HUMAN PRESCRIPTION DRUG SIMVASTATIN simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 St Marys Medical Park Pharmacy SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60760-009_60679870-7986-db7a-e053-2a91aa0a1dbf 60760-009 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 St Marys Medical Park Pharmacy CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-015_643fcae7-5afa-f1c4-e053-2991aa0a97eb 60760-015 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 St.Mary's Medical Park Pharmacy NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 60760-017_60c9f9d7-2900-33f7-e053-2a91aa0a9713 60760-017 HUMAN OTC DRUG Muscle Rub Menthol, Methyl salicylate CREAM TOPICAL 20110303 OTC MONOGRAPH NOT FINAL part348 St. Mary's Medical Park Pharmacy MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g N 20181231 60760-019_5fc8947f-3d6b-be6a-e053-2a91aa0a6b47 60760-019 HUMAN PRESCRIPTION DRUG SIMVASTATIN simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 St Marys Medical Park Pharmacy SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60760-024_6180eb78-0463-c665-e053-2a91aa0accf6 60760-024 HUMAN PRESCRIPTION DRUG GLIPIZIDE GLIPIZIDE TABLET ORAL 20130509 20180430 ANDA ANDA075795 St Marys Medical Park Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 60760-025_60a55a9c-b26f-2e5d-e053-2991aa0a9a2c 60760-025 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20151204 ANDA ANDA078542 St. Mary's Medical Park Pharmacy RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 60760-026_5fc8686a-bfc2-77ea-e053-2a91aa0ac5bc 60760-026 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 20140130 ANDA ANDA077824 St Marys Medical Park Pharmacy RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 60760-027_5fc8197e-8c6d-1b9c-e053-2a91aa0a3ae3 60760-027 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20100301 ANDA ANDA070974 St Marys Medical Park Pharmacy CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60760-032_5fd7b34f-dc4d-832c-e053-2a91aa0a8e97 60760-032 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 St. Mary's Medical Park Pharmacy HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 60760-035_c0d37c7c-05e5-401f-91e5-c4d644fbf1e7 60760-035 HUMAN PRESCRIPTION DRUG GABAPENTIN Gabapentin CAPSULE ORAL 20101201 ANDA ANDA075350 St Marys Medical Park Pharmacy GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60760-036_617e2da0-29a9-c7d6-e053-2a91aa0addf1 60760-036 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20130515 20180630 ANDA ANDA075155 St Marys Medical Park Pharmacy ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 60760-037_617e2da0-29a9-c7d6-e053-2a91aa0addf1 60760-037 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20130515 20180630 ANDA ANDA075155 St Marys Medical Park Pharmacy ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 60760-038_a7bab640-a6e2-4c75-b54f-4d556cbc9f6a 60760-038 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20101203 ANDA ANDA077525 St Marys Medical Park Pharmacy GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60760-039_5fc8d2ef-737c-2318-e053-2991aa0a2cb5 60760-039 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 St.Mary's Medical Park Pharmacy GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60760-042_60a5d3cd-168b-40f1-e053-2a91aa0a4553 60760-042 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 St Marys Medical Park Pharmacy METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60760-043_5fd565e0-8fea-2def-e053-2991aa0a2508 60760-043 HUMAN PRESCRIPTION DRUG WARFARIN SODIUM WARFARIN SODIUM TABLET ORAL 20130815 ANDA ANDA040663 St Marys Medical Park Pharmacy WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 60760-047_5fb22720-aa5d-3fee-e053-2991aa0abbbd 60760-047 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH FINAL part343 St Mary's Medical Park Pharmacy ASPIRIN 325 mg/1 N 20191231 60760-051_5fdb08aa-724c-45e0-e053-2a91aa0a856b 60760-051 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 St Marys Medical Park Pharmacy BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 60760-053_5fd54267-03dd-7373-e053-2991aa0a89bb 60760-053 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 St. Mary's Medical Park Pharmacy TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 60760-054_6155386d-6cfa-2095-e053-2a91aa0a52af 60760-054 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20110130 NDA NDA020859 St. Marys Medical Park Pharmacy METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20191231 60760-055_5fc4b67b-8e17-42db-e053-2a91aa0a7a4e 60760-055 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 St. Mary's Medical Park Pharmacy NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 60760-059_5fc5791f-e289-7de7-e053-2991aa0a2a41 60760-059 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 St Marys Medical Park Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-060_5fc5791f-e289-7de7-e053-2991aa0a2a41 60760-060 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 20180331 ANDA ANDA077877 St Marys Medical Park Pharmacy ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-061_5fb22720-aa64-3fee-e053-2991aa0abbbd 60760-061 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20130710 ANDA ANDA077877 St Marys Medical Park Pharmacy ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-063_60141386-67c8-1f56-e053-2a91aa0aac56 60760-063 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20130516 ANDA ANDA077912 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-064_60141386-67c8-1f56-e053-2a91aa0aac56 60760-064 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20130516 ANDA ANDA077912 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-065_60141386-67c8-1f56-e053-2a91aa0aac56 60760-065 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20130516 20180331 ANDA ANDA077912 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-069_643e1695-867b-d843-e053-2a91aa0a1ead 60760-069 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20151216 ANDA ANDA090624 St. Mary's Medical Park Pharmacy SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 60760-076_60cc9376-96f3-0283-e053-2a91aa0a35bc 60760-076 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20160104 ANDA ANDA075682 St. Mary's Medical Park Pharmacy IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 60760-077_5fc8118f-007c-0dba-e053-2991aa0a4283 60760-077 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20130814 ANDA ANDA077751 St Marys Medical Park Pharmacy PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60760-078_5fc8118f-007c-0dba-e053-2991aa0a4283 60760-078 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20130814 ANDA ANDA077751 St Marys Medical Park Pharmacy PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60760-081_5fc66a27-35b5-8cc5-e053-2991aa0a0c27 60760-081 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20150616 ANDA ANDA076820 St. Mary's Medical Park Pharmacy BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60760-082_5fc68eed-d12d-c8ce-e053-2991aa0a37a8 60760-082 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20140115 ANDA ANDA076820 St Marys Medical Park Pharmacy BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60760-088_5e20297a-5ba2-3ebe-e053-2991aa0aa655 60760-088 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20151230 ANDA ANDA090007 St. Mary's Medical Park Pharmacy GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60760-090_5f4b69de-8dde-26c5-e053-2a91aa0ab326 60760-090 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 St. Mary's Medical Park Pharmacy DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-093_6141c064-5cf9-2dd5-e053-2a91aa0afed0 60760-093 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20170619 ANDA ANDA203695 St. Mary's Medical Park Pharmacy METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 60760-094_5f4da67c-aa23-079f-e053-2a91aa0ac1ee 60760-094 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 St. Mary's Medical Park Pharmacy TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60760-097_6402bef4-e19d-0795-e053-2991aa0a3aa0 60760-097 HUMAN OTC DRUG Regular Strength Pain Relief Acetaminophen TABLET ORAL 20180129 OTC MONOGRAPH NOT FINAL part343 St. Mary's Medical Park Pharmacy ACETAMINOPHEN 325 mg/1 N 20191231 60760-099_5fc75d1c-3a20-b3e4-e053-2a91aa0a3d85 60760-099 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20150611 ANDA ANDA077584 St. Mary's Medical Park Pharmacy PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-100_60559fa9-25ef-39b4-e053-2a91aa0a2082 60760-100 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 St. Mary's Medical Park Pharmacy METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60760-110_60b5e277-5a47-2015-e053-2a91aa0a8e49 60760-110 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20120607 ANDA ANDA040823 St. Mary's Medical Park Pharmacy CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 60760-114_5fb0acc3-3e2d-732e-e053-2a91aa0af3cc 60760-114 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20130425 ANDA ANDA075798 St Marys Medical Park Pharmacy ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 60760-116_5fd5aac8-d1ff-9960-e053-2991aa0abeea 60760-116 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Extended Release ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130110 ANDA ANDA078148 St Marys Medical Park Pharmacy ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 60760-118_5fc54733-0c5b-1f6f-e053-2a91aa0a883f 60760-118 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20140220 ANDA ANDA090637 St Marys Medical Park Pharmacy ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 60760-121_e741e932-2307-4849-af17-1d5d14396c62 60760-121 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20110130 ANDA ANDA077653 St. Marys Medical Park Pharmacy VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-123_5f86a408-5222-ff7a-e053-2991aa0a4112 60760-123 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 St. Mary's Medical Park Pharmacy GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60760-128_6013c21f-7d51-4171-e053-2a91aa0a1975 60760-128 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 St Marys Medical Park Pharmacy LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-129_6013967e-0c06-4af3-e053-2991aa0a15c5 60760-129 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20130711 ANDA ANDA090467 St Marys Medical Park Pharmacy LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60760-132_5e1f9a1b-cd4f-2d04-e053-2991aa0a900b 60760-132 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 St. Mary's Medical Park Pharmacy AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60760-134_60cdcfc2-17b9-9a86-e053-2991aa0a1cf3 60760-134 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20171220 ANDA ANDA203154 St. Mary's Medical Park Pharmacy ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 60760-135_60cd209b-4a47-4fd9-e053-2a91aa0a4c7d 60760-135 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20160108 ANDA ANDA075682 St. Mary’s Medical Park Pharmacy IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-139_5efa5edb-01ea-e29a-e053-2991aa0ab9eb 60760-139 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20150429 ANDA ANDA203154 St. Mary's Medical Park Pharmacy ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 60760-140_639dd849-4992-9267-e053-2a91aa0a1444 60760-140 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 St. Mary's Medical Park Pharmacy NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 60760-141_6180eb78-0463-c665-e053-2a91aa0accf6 60760-141 HUMAN PRESCRIPTION DRUG GLIPIZIDE GLIPIZIDE TABLET ORAL 20130509 20180531 ANDA ANDA075795 St Marys Medical Park Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 60760-143_5fc71bc4-ec50-1cea-e053-2991aa0a2ce1 60760-143 HUMAN PRESCRIPTION DRUG CARVEDILOL CARVEDILOL TABLET, FILM COATED ORAL 20130425 ANDA ANDA078332 St Marys Medical Park Pharmacy CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 60760-144_5fc71bc4-ec50-1cea-e053-2991aa0a2ce1 60760-144 HUMAN PRESCRIPTION DRUG CARVEDILOL CARVEDILOL TABLET, FILM COATED ORAL 20130425 ANDA ANDA078332 St Marys Medical Park Pharmacy CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 60760-145_5fc71bc4-ec50-1cea-e053-2991aa0a2ce1 60760-145 HUMAN PRESCRIPTION DRUG CARVEDILOL CARVEDILOL TABLET, FILM COATED ORAL 20130425 ANDA ANDA078332 St Marys Medical Park Pharmacy CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 60760-151_5da4d357-547b-09a0-e053-2a91aa0ae672 60760-151 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 St. Mary's Medical Park Pharmacy PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 60760-152_5f4ef344-7881-3375-e053-2a91aa0a47b8 60760-152 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20160615 ANDA ANDA080704 St. Mary's Medical Park Pharmacy ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 60760-153_5d94e799-6758-726e-e053-2a91aa0a61ba 60760-153 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 St. Mary's Medical Park Pharnacy DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-155_60672da9-1048-2b4c-e053-2a91aa0a9412 60760-155 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20171215 ANDA ANDA040445 St. Mary's Medical Park Pharmacy METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 60760-157_642c7a42-021a-2a10-e053-2991aa0a8c39 60760-157 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20171215 ANDA ANDA090939 St. Mary's Medical Park Pharmacy ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 60760-159_60a02a15-a0d4-3894-e053-2991aa0a6a0b 60760-159 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20160419 ANDA ANDA202036 St. Mary's Medical Park Pharmacy VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-163_62081550-7bb2-30b1-e053-2991aa0a52d2 60760-163 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20180104 ANDA ANDA076900 St. Mary's Medical Park Pharmacy ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 60760-164_5e98459d-eb07-bab6-e053-2a91aa0aee3f 60760-164 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 St. Mary's Medical Park Pharmacy ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-170_5f4ba5f9-2a61-5f31-e053-2991aa0a534d 60760-170 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130321 ANDA ANDA202389 St. Mary's Medical Park Pharmacy ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-172_6050da7f-160c-4380-e053-2a91aa0a3624 60760-172 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 St. Mary's Medical Park Pharmacy AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60760-173_60cb89f6-e328-0773-e053-2a91aa0a33dd 60760-173 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20150809 ANDA ANDA077662 St. Mary’s Medical Park Pharmacy GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60760-177_60655eed-f302-2247-e053-2a91aa0ae079 60760-177 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20171215 ANDA ANDA077241 St. Mary's Medical Park Pharmacy BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 60760-178_61549269-1c92-57d7-e053-2991aa0a47a0 60760-178 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 St. Mary's Medical Park Pharmacy CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60760-179_641729a3-6df5-3a2f-e053-2991aa0a015e 60760-179 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20180131 ANDA ANDA040362 St. Mary's Medical Park Pharmacy PREDNISONE 10 mg/1 N 20191231 60760-186_61431e43-b117-4495-e053-2991aa0abdf0 60760-186 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20171226 ANDA ANDA202036 St. Mary’s Medical Park Pharmacy VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-190_5de3af7c-2c78-6b04-e053-2991aa0ae3fa 60760-190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 St. Mary's Medical Park Pharmacy NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-195_5fc86e48-1651-2176-e053-2991aa0a88e5 60760-195 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20160401 ANDA ANDA202389 St. Marys Medical Park Pharmacy ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-197_5fc88d07-c065-ac9a-e053-2a91aa0a27fd 60760-197 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20140206 ANDA ANDA202280 St. Mary's Medical Park Pharmacy ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-199_5f4c576f-cca6-ec7d-e053-2991aa0ad164 60760-199 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 St. Mary's Medical Park Pharmacy HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60760-200_98dd9ddf-c8e4-4dba-8a8f-2e6a0d25c606 60760-200 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20090608 ANDA ANDA040777 St. Mary's Medical Park Pharmacy OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60760-202_5fd7b34f-dc4d-832c-e053-2a91aa0a8e97 60760-202 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 St. Mary's Medical Park Pharmacy HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 60760-204_647951f7-6bd4-824f-e053-2991aa0ae6a1 60760-204 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN OXYCODONE HYDROCHLORIDE, ACETAMINOPHEN TABLET ORAL 20101217 20180531 ANDA ANDA040535 St Marys Medical Park Pharmacy OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 60760-208_5fc72ab0-80b1-5636-e053-2a91aa0a0b65 60760-208 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA076898 St. Mary's Medical Park Pharmacy CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-209_5fb2d00c-5f9e-3d0e-e053-2a91aa0ad3a7 60760-209 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 St. Mary's Medical Park Pharmacy CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-212_60a4fc89-f729-9b26-e053-2991aa0a898a 60760-212 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160226 ANDA ANDA202446 St. Mary's Medical Park Pharmacy AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60760-214_4cbb76ac-d42d-4f39-87bd-89cc83118914 60760-214 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET ORAL 20091201 ANDA ANDA040218 St. Mary's Medical Park Pharmacy AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60760-215_5fb35787-0790-5dc1-e053-2a91aa0a0849 60760-215 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 St Marys Medical Park Pharmacy DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 60760-216_61ce33c3-bffe-52bf-e053-2a91aa0a1221 60760-216 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20171214 ANDA ANDA077293 St. Mary's Medical Park Pharmacy FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 60760-217_61ce5414-7782-23ae-e053-2991aa0afa19 60760-217 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20171214 ANDA ANDA077293 St. Mary's Medical Park Pharmacy FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 60760-218_5f89fa25-2e34-949d-e053-2991aa0a84a1 60760-218 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120411 ANDA ANDA201013 St. Mary's Medical Park Pharmacy HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 60760-219_5f89b9f3-7a27-3109-e053-2991aa0a3a2f 60760-219 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120411 ANDA ANDA201013 St. Mary's Medical Park Pharmacy HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 60760-220_5f89c6b4-4990-3a6d-e053-2a91aa0aa017 60760-220 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120411 ANDA ANDA201013 St. Mary's Medical Park Pharmacy HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 60760-223_5fc72ab0-801c-5636-e053-2a91aa0a0b65 60760-223 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20130110 ANDA ANDA090659 St Marys Medical Park Pharmacy OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60760-226_620d5fe1-f7f8-8de7-e053-2a91aa0a8664 60760-226 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20140421 ANDA ANDA075483 St Marys Medical Park Pharmacy ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 60760-227_620d5fe1-f7f8-8de7-e053-2a91aa0a8664 60760-227 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20140421 ANDA ANDA075483 St Marys Medical Park Pharmacy ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 60760-230_5fd752a1-4abc-08c6-e053-2a91aa0afc17 60760-230 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20130509 ANDA ANDA077091 St Marys Medical Park Pharmacy GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 60760-231_5f4bd0ff-4ea5-3756-e053-2991aa0af689 60760-231 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride labetalol hydrochloride TABLET ORAL 20141201 NDA NDA018716 St. Mary's Medical Park Pharmacy LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-233_6052f830-4adb-34b3-e053-2991aa0a6cfa 60760-233 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 St. Mary's Medical Park Pharmacy CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 60760-234_5e99ffe7-6963-6a6c-e053-2a91aa0ad8e5 60760-234 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 St. Mary's Medical Park Pharmacy CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 60760-235_5e98cfdf-3348-2025-e053-2991aa0a036d 60760-235 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 St. Mary's Medical Park Pharmacy CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 60760-238_5fc5791f-e258-7de7-e053-2991aa0a2a41 60760-238 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20130425 ANDA ANDA077955 St Marys Medical Park Pharmacy AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60760-239_5fc54733-0c7b-1f6f-e053-2a91aa0a883f 60760-239 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110901 ANDA ANDA077955 St Marys Medical Park Pharmacy AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 60760-247_6052ce52-e56b-6518-e053-2991aa0aaf9d 60760-247 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070409 ANDA ANDA040597 St. Mary's Medical Park Pharmacy BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 60760-248_6142a6db-6daf-507c-e053-2991aa0a0923 60760-248 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20171226 ANDA ANDA078181 St. Mary’s Medical Park Pharmacy GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 60760-249_6063298c-e7ba-3a1b-e053-2a91aa0af11b 60760-249 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 St. Mary's Medical Park Pharmacy RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 60760-251_5fc3d3b4-26da-980a-e053-2a91aa0ada0d 60760-251 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET ORAL 20130515 ANDA ANDA074644 St Marys Medical Park Pharmacy METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-252_5fc3d3b4-26da-980a-e053-2a91aa0ada0d 60760-252 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET ORAL 20130515 ANDA ANDA074644 St Marys Medical Park Pharmacy METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-253_5e971360-b362-2eb3-e053-2991aa0ae03d 60760-253 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 St. Mary's Medical Park Pharmacy TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60760-255_6141e1ac-4f41-35b1-e053-2991aa0a6895 60760-255 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20171226 ANDA ANDA040362 St. Mary’s Medical Park Pharmacy PREDNISONE 5 mg/1 N 20191231 60760-260_6065b1b1-d7a0-6000-e053-2a91aa0a794d 60760-260 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET ORAL 20171215 ANDA ANDA078012 St. Mary's Medical Park Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 60760-266_60138eb1-6270-3f8b-e053-2991aa0a2152 60760-266 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20130516 ANDA ANDA075743 St Marys Medical Park Pharmacy LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-267_6013c21f-7d51-4171-e053-2a91aa0a1975 60760-267 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 St Marys Medical Park Pharmacy LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-270_6013c21f-7d51-4171-e053-2a91aa0a1975 60760-270 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 St Marys Medical Park Pharmacy LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-271_3b4780f7-cb0d-4b99-b667-746ddeca8146 60760-271 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Extended-Release Diclofenac Sodium TABLET, EXTENDED RELEASE ORAL 20020107 ANDA ANDA075910 St Marys Medical Park Pharmacy DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-274_6052a964-eeaf-a4be-e053-2a91aa0aaa19 60760-274 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20130715 ANDA ANDA201972 St. Mary's Medical Park Pharmacy OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60760-276_6063dcca-a00b-c10d-e053-2a91aa0a8b99 60760-276 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20130715 ANDA ANDA201972 St. Mary's Medical Park Pharmacy OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60760-279_60156bc0-2100-1ac6-e053-2991aa0a1a33 60760-279 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20101229 ANDA ANDA079153 St Marys Medical Park Pharmacy TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60760-288_5fd57f18-abf8-540c-e053-2991aa0affcb 60760-288 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 St. Mary's Medical Park Pharmacy ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 60760-291_5fd7f64b-05c4-e371-e053-2991aa0a491f 60760-291 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 20140130 ANDA ANDA075133 St Marys Medical Park Pharmacy LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-294_6312c9a6-d4d4-eb1f-e053-2991aa0a5e68 60760-294 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20180118 ANDA ANDA091276 St. Mary's Medical Park Pharmacy INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 60760-300_61e196ba-1779-8c26-e053-2a91aa0a1af0 60760-300 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20160401 ANDA ANDA077147 St Marys Medical Park Pharmacy CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 60760-305_5fc653bf-2021-6cf6-e053-2991aa0a2fe8 60760-305 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20140523 ANDA ANDA090469 St Marys Medical Park Pharmacy ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 60760-306_5fc6486e-860c-5c7b-e053-2991aa0a8d14 60760-306 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20160401 ANDA ANDA090469 St Marys Medical Park Pharmacy ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 60760-307_60cbfd2a-63ed-3652-e053-2a91aa0ab692 60760-307 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20111031 ANDA ANDA204279 St. Mary’s Medical Park Pharmacy HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 60760-308_5fc87179-7b12-8690-e053-2a91aa0adb8f 60760-308 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20160401 ANDA ANDA077206 St Marys Medical Park Pharmacy SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-309_5fc8605a-71f5-6b8d-e053-2991aa0a7ccb 60760-309 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20140205 ANDA ANDA077397 St Marys Medical Park Pharmacy SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-310_5fc8605a-71f5-6b8d-e053-2991aa0a7ccb 60760-310 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20140205 ANDA ANDA077397 St Marys Medical Park Pharmacy SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-312_5fb22720-aa60-3fee-e053-2991aa0abbbd 60760-312 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET ORAL 20140522 ANDA ANDA202640 St Marys Medical Park Pharmacy. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 60760-314_60cc2d39-745a-87a4-e053-2a91aa0a8a42 60760-314 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20150608 ANDA ANDA074754 St. Mary’s Medical Park Pharmacy KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 60760-319_6362cf04-3d0d-fe5f-e053-2991aa0a8f9c 60760-319 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110131 ANDA ANDA090404 St. Mary's Medical Park Pharmacy TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20191231 60760-325_5fc88205-9c65-a4ed-e053-2a91aa0aaa02 60760-325 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 St. Mary's Medical Park Pharmacy ESZOPICLONE 2 mg/1 CIV N 20181231 60760-330_60cb3375-80f3-7dc7-e053-2a91aa0a6ccd 60760-330 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20160314 OTC MONOGRAPH FINAL part341 St. Mary’s Medical Park Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 60760-334_5fc40312-5fb8-dfed-e053-2a91aa0a17f4 60760-334 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET ORAL 20130110 ANDA ANDA070033 St Marys Medical Park Pharmacy METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 60760-335_6065f1a0-8428-5410-e053-2a91aa0a51dd 60760-335 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20171215 ANDA ANDA090460 St. Mary's Medical Park Pharmacy ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 60760-336_60689b96-cb59-925a-e053-2a91aa0a32a3 60760-336 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20171215 ANDA ANDA203458 St. Mary's Medical Park Pharmacy METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 60760-337_60c9aca8-2b54-5fdd-e053-2991aa0a19e3 60760-337 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20170217 ANDA ANDA065242 St. Mary’s Medical Park Pharmacy CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 60760-339_5fdbfca5-67c9-358e-e053-2991aa0a4eb4 60760-339 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130711 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 60760-340_5fdbe03e-7b32-18e9-e053-2991aa0a2d72 60760-340 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20130516 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 60760-341_5fdbe03e-7b32-18e9-e053-2991aa0a2d72 60760-341 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LLEVOTHYROXINE SODIUM TABLET ORAL 20130516 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 60760-342_5fdbfca5-67c9-358e-e053-2991aa0a4eb4 60760-342 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130711 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 60760-343_5fdbfca5-67c9-358e-e053-2991aa0a4eb4 60760-343 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20130711 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 60760-345_60138eb1-626f-3f8b-e053-2991aa0a2152 60760-345 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20130110 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 60760-346_5fdbe03e-7b32-18e9-e053-2991aa0a2d72 60760-346 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20130516 NDA NDA021210 St Marys Medical Park Pharmacy LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 60760-347_5fb4056c-603a-fdca-e053-2a91aa0a4431 60760-347 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 St. Mary's Medical Park Pharmacy METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 60760-351_5e9886a3-0d57-15e6-e053-2a91aa0a1586 60760-351 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 St. Mary's Medical Park Pharmacy BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60760-352_5e9a61dd-9b2f-5b86-e053-2a91aa0a365c 60760-352 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 St. Mary's Medical Park Pharmacy BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 60760-353_5fc5870f-9497-61d6-e053-2a91aa0a1202 60760-353 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE TABLET, FILM COATED ORAL 20140420 ANDA ANDA090548 St Marys Medical Park Pharmacy ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 60760-354_5fc5870f-9497-61d6-e053-2a91aa0a1202 60760-354 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE TABLET, FILM COATED ORAL 20140420 ANDA ANDA090548 St Marys Medical Park Pharmacy ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 60760-355_5fc5b32e-b5c0-21b6-e053-2a91aa0aa849 60760-355 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20140115 ANDA ANDA090548 St Marys Medical Park Pharmacy ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 60760-357_6062f3a8-5867-200a-e053-2991aa0a7031 60760-357 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 St. Mary's Medical Park Pharmacy LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-358_6051e2b2-910a-602d-e053-2991aa0af163 60760-358 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20171214 ANDA ANDA076180 St. Mary's Medical Park Pharmacy LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-359_5f4c1a62-fb85-8cdc-e053-2a91aa0a671a 60760-359 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 St. Mary's Medical Park Pharmacy LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-360_5eff766f-82e3-4cd6-e053-2a91aa0a4782 60760-360 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 St. Mary's Medical Park Pharmacy LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-362_60653bcb-53a3-063e-e053-2991aa0af6bd 60760-362 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan potassium TABLET, FILM COATED ORAL 20171215 ANDA ANDA091497 St. Mary's Medical Park Pharmacy LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 60760-367_60a542d8-92db-0324-e053-2a91aa0a95da 60760-367 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160603 ANDA ANDA202446 St. Mary's Medical Park Pharmacy AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60760-370_617d67b3-42c4-fb59-e053-2991aa0abd29 60760-370 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130711 20180831 ANDA ANDA075991 St Marys Medical Park Pharmacy LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 60760-371_617d7e1c-1647-4104-e053-2991aa0a7e9e 60760-371 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140130 20180731 ANDA ANDA075991 St Marys Medical Park Pharmacy LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 60760-372_617da096-792e-624d-e053-2a91aa0a95a0 60760-372 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140421 20180831 ANDA ANDA075991 St Marys Medical Park Pharmacy LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 60760-377_5fdb33ec-089c-2754-e053-2991aa0a9855 60760-377 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20141006 ANDA ANDA075964 St. Mary's Medical Park Pharmacy TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 60760-384_5fb35f67-7c1e-89c1-e053-2991aa0a13bf 60760-384 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20160401 OTC MONOGRAPH NOT FINAL part334 St. Marys Medical Park Pharmacy DOCUSATE SODIUM 100 mg/1 N 20181231 60760-388_5fd76bcb-6ccb-5eda-e053-2a91aa0ab803 60760-388 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 St. Mary's Medical Park Pharmacy HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 60760-394_5fd768cc-a87d-1bcf-e053-2a91aa0ac95a 60760-394 HUMAN PRESCRIPTION DRUG Glipizide XL Glipizide TABLET, EXTENDED RELEASE ORAL 20140523 NDA AUTHORIZED GENERIC NDA020329 St Marys Medical Park Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 60760-399_5f4f878c-ecbf-467f-e053-2991aa0a0c6a 60760-399 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20170330 ANDA ANDA077797 St. Mary's Medical Park Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 60760-401_6064b662-4dd7-39f1-e053-2a91aa0a4d59 60760-401 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20171215 ANDA ANDA075520 St. Mary's Medical Park Pharmacy NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60760-404_60c9bcc8-f7b6-482f-e053-2a91aa0aba24 60760-404 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20160203 ANDA ANDA077927 St. Mary's Medical Park Pharmacy MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-407_6065b1b1-d7dc-6000-e053-2a91aa0a794d 60760-407 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20171215 ANDA ANDA075932 St. Mary's Medical Park Pharmacy BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60760-410_5fdb4f4e-0eff-99b0-e053-2991aa0a6793 60760-410 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20120401 ANDA ANDA077068 St Marys Medical Park Pharmacy BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 60760-413_5fd76bcb-6cc9-5eda-e053-2a91aa0ab803 60760-413 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070501 ANDA ANDA084325 St Marys Medical Park Pharmacy HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60760-417_5fb3261c-567a-3b4c-e053-2991aa0a13db 60760-417 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 St. Mary's Medical Park Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 60760-418_61f94dca-8116-0570-e053-2a91aa0a4fd3 60760-418 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20170711 ANDA ANDA077797 St. Mary's Medical Park Pharmacy CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 60760-419_643b8738-2fe7-27ed-e053-2a91aa0a06bd 60760-419 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20160203 ANDA ANDA077927 St. Mary's Medical Park Pharmacy MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 60760-420_5fd76e68-5bf1-0688-e053-2991aa0a7401 60760-420 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20140421 ANDA ANDA077836 St Marys Medical Park Pharmacy GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20191231 60760-425_60559044-86b4-4335-e053-2991aa0a00e3 60760-425 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 St. Mary's Medical Park Pharmacy MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 60760-426_5f4d65bf-7ad1-81b1-e053-2a91aa0a7c99 60760-426 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 St. Mary's Medical Park Pharmacy METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-434_60b35512-c619-3b99-e053-2991aa0a40f2 60760-434 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072193 St. Mary's Medical Park Pharmacy TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 60760-436_5fd52e68-4d0c-6896-e053-2a91aa0ad2e6 60760-436 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20160614 ANDA ANDA071525 St. Mary's Medical Park Pharmacy TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 60760-440_60b38b52-19e0-2185-e053-2a91aa0a8ef4 60760-440 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072192 St. Mary's Medical Park Pharmacy TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 60760-446_5d6c5a69-b68b-b308-e053-2a91aa0a9954 60760-446 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20140522 20180228 ANDA ANDA074225 St Marys Medical Park Pharmacy BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 60760-449_5fc7b20d-a4a0-10d7-e053-2a91aa0ae78e 60760-449 HUMAN OTC DRUG Pharbetol Regular strength Acetaminophen TABLET ORAL 20160101 OTC MONOGRAPH NOT FINAL part343 St. Mary's Medical Park Pharmacy ACETAMINOPHEN 325 mg/1 N 20181231 60760-457_60cc6750-704c-fc13-e053-2991aa0a2109 60760-457 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20160506 ANDA ANDA071404 St. Mary’s Medical Park Pharmacy LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60760-460_5fc6486e-85bd-5c7b-e053-2991aa0a8d14 60760-460 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 19990101 ANDA ANDA091305 St. Mary's Medical Park Pharmacy NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-464_617f8dd2-619b-5569-e053-2991aa0ab057 60760-464 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20140421 20180531 ANDA ANDA086242 St Marys Medical Park Pharmacy HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 60760-467_5f4b2958-3d9c-a054-e053-2991aa0a84c9 60760-467 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 St. Mary's Medical Park Pharmacy METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-468_5f4ae557-bddb-7a97-e053-2a91aa0a1f17 60760-468 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 St. Mary's Medical Park Pharmacy METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-472_60636fa0-18f5-3875-e053-2a91aa0acb11 60760-472 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 St. Marys Medical Park Pharmacy LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60760-476_61fbfd43-f70b-3f0a-e053-2a91aa0acf06 60760-476 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20171215 ANDA ANDA091604 St. Mary's Medical Park Pharmacy RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 60760-477_60691d4f-fd39-d59c-e053-2a91aa0a5d2b 60760-477 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20171215 ANDA ANDA091604 St. Mary's Medical Park Pharmacy RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-488_5fc6e421-0a5d-0f3f-e053-2a91aa0aae9d 60760-488 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140116 ANDA ANDA077455 St Marys Medical Park Pharmacy BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 60760-495_5fc76dc6-56fa-4de6-e053-2991aa0a9b77 60760-495 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20140123 ANDA ANDA078216 St Marys Medical Park Pharmacy CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-498_5fc854b7-7262-6535-e053-2991aa0a2dff 60760-498 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 St. Mary's Medical Park Pharmacy ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 60760-503_60a5d3cd-169d-40f1-e053-2a91aa0a4553 60760-503 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20151203 ANDA ANDA076533 St. Mary's Medical Park Pharmacy TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60760-508_6313374a-fea5-55c5-e053-2a91aa0aaf58 60760-508 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20171130 ANDA ANDA075520 St. Mary's Medical Park Pharmacy NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20191231 60760-512_6259f1bd-86c3-5c28-e053-2a91aa0a7b5e 60760-512 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20140116 20190331 ANDA ANDA076639 St Marys Medical Park Pharmacy CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 60760-515_5fd5aac8-d1c2-9960-e053-2991aa0abeea 60760-515 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 St Marys Medical Park Pharmacy ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 60760-521_60c84f75-84b3-78bd-e053-2a91aa0a7afb 60760-521 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20140130 ANDA ANDA076048 St. Mary's Medical Park Pharmacy OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 60760-527_60632050-86b6-5942-e053-2a91aa0acc99 60760-527 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20061023 ANDA ANDA076939 St. Mary's Medical Park Pharmacy PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60760-528_606814a3-8f74-74e4-e053-2a91aa0a6aa0 60760-528 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20171215 ANDA ANDA076939 St. Mary's Medical Park Pharmacy PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60760-535_60b3caaa-e71a-515e-e053-2a91aa0aa671 60760-535 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene, Hydrochlorothiazide CAPSULE ORAL 20140422 ANDA ANDA201407 St. Mary's Medical Park Pharmacy TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60760-546_61e3270e-8e31-7cb3-e053-2991aa0a5f45 60760-546 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20140522 20180228 ANDA ANDA090686 St Marys Medical Park Pharmacy DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20191231 60760-547_61e3270e-8e31-7cb3-e053-2991aa0a5f45 60760-547 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20140522 20180430 ANDA ANDA090686 St Marys Medical Park Pharmacy DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20191231 60760-549_5fb37926-9b41-8eee-e053-2a91aa0a7bc7 60760-549 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20161001 ANDA ANDA077783 St. Mary's Medical Park Pharmacy LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 60760-552_60cb4e75-40af-ad58-e053-2a91aa0a3e24 60760-552 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20151112 ANDA ANDA076004 St. Mary’s Medical Park Pharmacy ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-557_6065e704-93ea-4214-e053-2a91aa0a7947 60760-557 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20171215 ANDA ANDA075350 St. Mary's Medical Park Pharmacy GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60760-570_61424b3a-3086-a2c4-e053-2991aa0a71a4 60760-570 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20171226 ANDA ANDA063083 St. Mary’s Medical Park Pharmacy. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 60760-598_6142d7b6-e5eb-1af0-e053-2991aa0a00cd 60760-598 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20171226 ANDA ANDA202433 St. Mary’s Medical Park Pharmacy TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 60760-600_5fc7d701-b134-9b41-e053-2991aa0ac372 60760-600 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130515 NDA AUTHORIZED GENERIC NDA018279 St Marys Medical Park Pharmacy POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 60760-600_60c82f39-f0b1-52d2-e053-2a91aa0ac0d6 60760-600 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151116 NDA AUTHORIZED GENERIC NDA018279 St. Mary's Medical Park Pharmacy POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 60760-601_5fc7d050-4073-4263-e053-2a91aa0aeae4 60760-601 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, EXTENDED RELEASE ORAL 20130516 ANDA ANDA076368 St Marys Medical Park Pharmacy . POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 60760-605_6180446a-8573-3585-e053-2a91aa0a90d8 60760-605 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20171226 ANDA ANDA090007 St. Mary’s Medical Park Pharmacy GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60760-611_5e98b2ab-018f-641d-e053-2991aa0ad4c1 60760-611 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 St. Mary's Medical Park Pharmacy SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-622_6063a374-1831-3ae6-e053-2991aa0ae031 60760-622 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 St. Mary's Medical Park Pharmacy TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 60760-623_60a0fd58-8b5b-21be-e053-2a91aa0afa37 60760-623 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE EXTENDED RELEASE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20160512 ANDA ANDA090295 St. Marys Medical Park Pharmacy METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60760-624_5fc8a87b-f644-f951-e053-2991aa0a3543 60760-624 HUMAN PRESCRIPTION DRUG FUROSEMIDE FUROSEMIDE TABLET ORAL 20130509 ANDA ANDA078010 St Marys Medical Park Pharmacy FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 60760-625_5fc8a87b-f644-f951-e053-2991aa0a3543 60760-625 HUMAN PRESCRIPTION DRUG FUROSEMIDE FUROSEMIDE TABLET ORAL 20130509 ANDA ANDA078010 St Marys Medical Park Pharmacy FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 60760-627_60cb7785-3043-2098-e053-2991aa0ad3e7 60760-627 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20161122 ANDA ANDA090705 St. Mary’s Medical Park Pharmacy GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60760-629_5fc840ba-245d-52a3-e053-2a91aa0aa60c 60760-629 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20130815 ANDA ANDA040256 St Marys Medical Park Pharmacy PREDNISONE 5 mg/1 N 20181231 60760-630_60c7fce3-3650-19ad-e053-2a91aa0acbf7 60760-630 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20151020 ANDA ANDA040362 St. Mary's Medical Park Pharmacy PREDNISONE 10 mg/1 N 20191231 60760-632_5fc840ba-2466-52a3-e053-2a91aa0aa60c 60760-632 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140101 ANDA ANDA078832 BluePoint Laboratories RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-633_5fc840ba-2466-52a3-e053-2a91aa0aa60c 60760-633 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140101 ANDA ANDA078832 BluePoint Laboratories RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 60760-636_5fc66a27-3572-8cc5-e053-2991aa0a0c27 60760-636 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 St. Mary's Medical Park Pharmacy ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 60760-637_5fc673f7-f6f3-9e9b-e053-2991aa0a0f08 60760-637 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 St. Mary's Medical Park Pharmacy ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 60760-647_60cb4de0-ed89-a46b-e053-2a91aa0a8b6d 60760-647 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20130708 ANDA ANDA078619 St. Mary’s Medical Park Pharmacy FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-650_60cbeaac-ab83-0716-e053-2a91aa0a7888 60760-650 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20160603 ANDA ANDA075209 St. Mary’s Medical Park Pharmacy LORATADINE 10 mg/1 N 20181231 60760-652_60a4e1b3-994d-8e7f-e053-2a91aa0a769a 60760-652 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20160329 ANDA ANDA075677 St. Mary's Medical Park Pharmacy ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 60760-693_5fc7f5d5-6165-6447-e053-2991aa0adc4d 60760-693 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20050812 ANDA ANDA065243 St. Mary's Medical Park Pharmacy CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 60760-696_5fd5aac8-d207-9960-e053-2991aa0abeea 60760-696 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 St. Mary's Medical Park Pharmacy NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-701_5fc40312-5fdd-dfed-e053-2a91aa0a17f4 60760-701 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160401 ANDA ANDA203849 St Marys Medical Park Pharmacy MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60760-702_5fc40312-5fdd-dfed-e053-2a91aa0a17f4 60760-702 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160401 ANDA ANDA203849 St Marys Medical Park Pharmacy MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60760-703_5f8a45da-3739-fc2f-e053-2991aa0a4582 60760-703 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101206 NDA AUTHORIZED GENERIC NDA021774 St. Mary's Medical Park Pharmacy ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 60760-706_64071e7e-e9cd-b228-e053-2a91aa0a26ec 60760-706 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20180131 ANDA ANDA040616 St. Mary's Medical Park Pharmacy WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 60760-718_5f215709-3792-7668-e053-2a91aa0ac332 60760-718 HUMAN OTC DRUG Plus Pharma NSAID Aspirin ASPIRIN TABLET ORAL 20060327 OTC MONOGRAPH FINAL part343 St. Mary's Medical Park Pharmacy ASPIRIN 325 mg/1 N 20191231 60760-745_6402e751-8c47-76d8-e053-2991aa0abffb 60760-745 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20180130 ANDA ANDA076159 St. Mary's Medical Park Pharmacy GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 60760-746_620dfd39-9003-0de0-e053-2a91aa0a6879 60760-746 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20180108 ANDA ANDA076159 St. Mary's Medical Park Pharmacy GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 60760-749_5fc854b7-725c-6535-e053-2991aa0a2dff 60760-749 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20140522 ANDA ANDA040833 St Marys Medical Park Pharmacy ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 60760-760_6014342d-ad48-ae71-e053-2991aa0a8929 60760-760 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20140523 ANDA ANDA077948 St Marys Medical Park Pharmacy LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60760-782_5fc8a87b-f686-f951-e053-2991aa0a3543 60760-782 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20150818 ANDA ANDA091283 St. Mary's Medical Park Pharmacy TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 60760-789_5fb33fba-46db-5f01-e053-2991aa0a8d89 60760-789 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19951130 ANDA ANDA074394 St. Mary's Medical Park Pharmacy DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-791_60cc3b2c-11cd-978b-e053-2a91aa0aa356 60760-791 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20160929 OTC MONOGRAPH NOT FINAL part343 St. Mary's Medical Park Pharmacy IBUPROFEN 200 mg/1 N 20181231 60760-795_5fc8197e-8c6e-1b9c-e053-2a91aa0a3ae3 60760-795 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 St. Mary's Medical Park Pharmacy DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 60760-804_5fc8a87b-f643-f951-e053-2991aa0a3543 60760-804 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20160401 ANDA ANDA077253 St Marys Medical Park Pharmacy FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 60760-810_5fc66a27-35b6-8cc5-e053-2991aa0a0c27 60760-810 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 St. Mary's Medical Park Pharmacy ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 60760-811_60ca7484-6201-29d8-e053-2a91aa0a168a 60760-811 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20170316 ANDA ANDA075520 St. Mary's Medical Park Pharmacy NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60760-812_5fc4c197-81ba-4921-e053-2a91aa0a7d54 60760-812 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20140523 ANDA ANDA073555 St Marys Medical Park Pharmacy NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 60760-813_5fb1683a-1beb-fa7e-e053-2a91aa0a35ea 60760-813 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20160401 ANDA ANDA074112 St. Marys Medical Park Pharmacy ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 60760-815_6259f1bd-86c3-5c28-e053-2a91aa0a7b5e 60760-815 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20140116 ANDA ANDA076639 St Marys Medical Park Pharmacy CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 60760-826_606508d3-d459-834d-e053-2991aa0aabf9 60760-826 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20171215 ANDA ANDA202764 St. Mary's Medical Park Pharmacy GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 60760-830_60b5b3b1-a1a2-e84a-e053-2a91aa0ad4fd 60760-830 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20121219 ANDA ANDA091179 St. Mary's Medical Park Pharmacy PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 60760-834_6068c939-a6e4-d525-e053-2a91aa0aa6db 60760-834 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20171215 ANDA ANDA077397 St. Mary's Medical Park Pharmacy SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-835_6142ca63-e003-0541-e053-2a91aa0a6adb 60760-835 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20171226 ANDA ANDA077397 St. Mary’s Medical Park Pharmacy SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 60760-849_5e1ec496-0d5b-1d54-e053-2991aa0a1c6c 60760-849 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 St. Mary's Medical Park Pharmacy CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60760-855_5fc6d529-0a01-31bb-e053-2991aa0a5f87 60760-855 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110111 ANDA ANDA076636 St Marys Medical Park Pharmacy OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60760-900_61d137e1-f9ac-e141-e053-2a91aa0af14c 60760-900 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE CAPSULE ORAL 20130502 20180331 ANDA ANDA075868 St Marys Medical Park Pharmacy FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20191231 60760-902_61d147cf-f3c9-032d-e053-2a91aa0acfe9 60760-902 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20140421 20180430 ANDA ANDA075868 St Marys Medical Park Pharmacy FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20191231 60760-903_6051ef90-2b7b-422b-e053-2a91aa0a65a3 60760-903 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 St. Mary's Medical Park Pharmacy ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60760-904_5e963ce7-bf33-2cf9-e053-2991aa0a83ad 60760-904 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 St. Mary's Medical Park Pharmacy ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60760-905_6064d709-f6b4-38a4-e053-2991aa0a3482 60760-905 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20171215 ANDA ANDA091624 St. Mary's Medical Park Pharmacy ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 60760-911_606447e9-84e6-c156-e053-2991aa0affa6 60760-911 HUMAN PRESCRIPTION DRUG Fentanyl FENTANYL PATCH TRANSDERMAL 20110126 20190331 ANDA ANDA077062 St. Marys Medical Park Pharmacy FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60760-912_606447e9-84e6-c156-e053-2991aa0affa6 60760-912 HUMAN PRESCRIPTION DRUG Fentanyl FENTANYL PATCH TRANSDERMAL 20110126 20190531 ANDA ANDA077062 St. Marys Medical Park Pharmacy FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60760-933_5fc6a89f-42dc-3591-e053-2991aa0ae821 60760-933 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen OXYCODONE HYDROCHLORIDE, ACETAMINOPHEN TABLET ORAL 20101222 ANDA ANDA040545 St Marys Medical Park Pharmacy OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 60760-935_5e983b65-2be8-ca0e-e053-2991aa0a62d2 60760-935 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20110421 OTC MONOGRAPH NOT FINAL part343 St. Mary's Medical Park Pharmacy ACETAMINOPHEN 325 mg/1 N 20181231 60760-973_5fb278b9-2e0c-be30-e053-2991aa0a7965 60760-973 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130515 ANDA ANDA090564 St Marys Medical Park Pharmacy METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60760-974_5fb278b9-2e0c-be30-e053-2991aa0a7965 60760-974 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130515 ANDA ANDA090564 St Marys Medical Park Pharmacy METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60760-975_5fb278b9-2e0c-be30-e053-2991aa0a7965 60760-975 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20130515 ANDA ANDA090564 St Marys Medical Park Pharmacy METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 60760-976_9734ae55-fbed-4a4e-9719-cd4728b49e68 60760-976 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130808 ANDA ANDA090615 St Marys Medical Park Pharmacy METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-977_61e76ac6-709d-4c5c-e053-2a91aa0a14e6 60760-977 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE ORAL 20130808 20180430 ANDA ANDA090617 St Marys Medical Park Pharmacy METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 60760-978_9734ae55-fbed-4a4e-9719-cd4728b49e68 60760-978 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130808 ANDA ANDA090615 St Marys Medical Park Pharmacy METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 60760-981_5fc8686a-c005-77ea-e053-2a91aa0ac5bc 60760-981 HUMAN PRESCRIPTION DRUG SPIRONOLACTONE SPIRONOLACTONE TABLET ORAL 20130522 ANDA ANDA089424 St Marys Medical Park Pharmacy SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 60762-112_2ced41a4-4ada-4251-bfec-9445f2b748dd 60762-112 HUMAN OTC DRUG CA-REZZ NORISC ANTIBACTERIAL SKIN CARE BENZETHONIUM CHLORIDE CREAM TOPICAL 20180205 OTC MONOGRAPH NOT FINAL part333A FNC MEDICAL CORPORATION BENZETHONIUM CHLORIDE .2 g/100g N 20191231 60762-113_7ca16221-5656-4e3d-b282-718a76269349 60762-113 HUMAN OTC DRUG CA-REZZ - NORISC - INCONTINENT WASH BENZETHONIUM CHLORIDE SOLUTION TOPICAL 20180205 OTC MONOGRAPH NOT FINAL part333A FNC MEDICAL CORPORATION BENZETHONIUM CHLORIDE .12 g/100mL N 20191231 60762-151_69843d75-59b1-41c1-b4d1-a6b4663d3ddd 60762-151 HUMAN OTC DRUG CA-REZZ - LONG TERM CARE - INCONTINENT CLEANSER BENZETHONIUM CHLORIDE SOLUTION TOPICAL 20180205 OTC MONOGRAPH NOT FINAL part333A FNC MEDICAL CORPORATION BENZETHONIUM CHLORIDE .12 g/100mL N 20191231 60763-376_13e8c2a3-aa10-43f9-9fc0-d998bde5cd13 60763-376 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20170410 ANDA ANDA078944 STASON PHARMACEUTICALS, INC ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 60764-001_14f5bdaf-bd15-435e-8822-b32226c730b5 60764-001 HUMAN OTC DRUG 3 CONCEPT EYES GLOSSING WATERFUL FOUNDATION MILK IVORY Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 1.44 g/40g N 20181231 60764-002_0d22c4b9-3a29-4bae-b4ea-9cb80d9840e8 60764-002 HUMAN OTC DRUG 3 CONCEPT EYES GLOSSING WATERFUL FOUNDATION NATURAL IVORY Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 1.44 g/40g N 20181231 60764-003_c3823aaa-5894-4096-a9dd-f0afff30df6b 60764-003 HUMAN OTC DRUG 3 CONCEPT EYES GLOSSING WATERFUL FOUNDATION NUDE BEIGE Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 1.44 g/40g N 20181231 60764-004_35a3eaa6-40d8-431c-8e4d-a2fa482e768f 60764-004 HUMAN OTC DRUG 3 CONCEPT EYES GLOSSING WATERFUL FOUNDATION SOFT BEIGE Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 1.44 g/40g N 20181231 60764-005_c8d714e3-482f-4247-b6bb-2e9acee943da 60764-005 HUMAN OTC DRUG 3 CONCEPT EYES HONEY FACE CHIFFON FLUID 001 Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 3.71 mg/40mL N 20181231 60764-006_ca8b90eb-db68-401a-a92f-80cc1c2dd81a 60764-006 HUMAN OTC DRUG 3 CONCEPT EYES HONEY FACE CHIFFON FLUID 002 Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 3.71 mg/40mL N 20181231 60764-007_0feb4cc7-5e70-42f7-ab82-97a8b2dc0b2d 60764-007 HUMAN OTC DRUG 3 CONCEPT EYES LIQUID FOUNDATION IVORY BEIGE Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 2.78 mg/30mL N 20181231 60764-008_02c8324d-627d-41f4-bcab-f59b06882737 60764-008 HUMAN OTC DRUG 3 CONCEPT EYES LIQUID FOUNDATION LACE BEIGE Titanium Dioxide CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE 2.78 mg/30mL N 20181231 60764-009_465cf293-f75f-4fa9-a06d-d512a0aef080 60764-009 HUMAN OTC DRUG 3 CONCEPT EYES SLIM FIT PACT NATURAL IVORY Titanium Dioxide POWDER TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE .57 g/8g N 20181231 60764-010_21cc3ea3-e3b3-4333-96e1-aa7b64c8a4c1 60764-010 HUMAN OTC DRUG 3 CONCEPT EYES SLIM FIT PACT SOFT BEIGE Titanium Dioxide POWDER TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE .57 g/8g N 20181231 60764-011_b3aa2f5a-c861-4b79-a873-08f41061efe2 60764-011 HUMAN OTC DRUG 3 CONCEPT EYES BACK TO BABY Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 NANDA CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 2.9; 1.5 mg/30mL; mg/30mL N 20181231 60764-012_e7b0afdd-e295-493a-9486-e76d9fb1d8a6 60764-012 HUMAN OTC DRUG 3CE SHIMMER PEACH Titanium Dioxide STICK TOPICAL 20160815 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .47 g/10g N 20181231 60764-013_f38aadbe-b3cc-4315-9cc2-6d9677843a9e 60764-013 HUMAN OTC DRUG 3CE SHIMMER PINK Titanium Dioxide STICK TOPICAL 20160815 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .4 g/10g N 20181231 60764-014_8f58a769-3f9f-466e-8db8-7ae4683bf939 60764-014 HUMAN OTC DRUG 3CE PORE SILKY BALM Titanium Dioxide POWDER TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .12 g/25g N 20181231 60764-015_03bf9b12-94c1-47c3-a47c-29f28d51eafe 60764-015 HUMAN OTC DRUG 3CE MAGIC TOUCH FACE MAKER PINK Titanium Dioxide POWDER TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE 1.63 g/11g N 20181231 60764-016_04a5df3a-2f77-4625-be42-3d403cc3a882 60764-016 HUMAN OTC DRUG 3CE MAGIC TOUCH FACE MAKER BEIGE Titanium Dioxide POWDER TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE 1.03 g/11g N 20181231 60764-017_c2358846-6fbe-4db5-9ae9-fb37db1a3f99 60764-017 HUMAN OTC DRUG 3CE SUPER SLIM PEN EYE LINER BLACK Butylene Glycol LIQUID TOPICAL 20160810 UNAPPROVED DRUG OTHER Nanda Co., Ltd BUTYLENE GLYCOL .04 g/.9mL N 20181231 60764-018_0e297fba-91a4-41a7-b311-61b0281610f7 60764-018 HUMAN OTC DRUG 3CE SUPER SLIM PEN EYE LINER BROWN Butylene Glycol LIQUID TOPICAL 20160810 UNAPPROVED DRUG OTHER Nanda Co., Ltd BUTYLENE GLYCOL .05 g/.9mL N 20181231 60764-019_fd7cb4a3-7761-4518-9554-d34d06edc2a6 60764-019 HUMAN OTC DRUG 3CE SUPER SLIM PEN EYE LINER LIGHT BROWN Butylene Glycol LIQUID TOPICAL 20160810 UNAPPROVED DRUG OTHER Nanda Co., Ltd BUTYLENE GLYCOL .05 g/.9mL N 20181231 60764-020_25fcf1d4-256b-48fd-bab0-2f1100407f7e 60764-020 HUMAN OTC DRUG 3CE SUPER SLIM PEN EYE LINER BURGUNDY BROWN Butylene Glycol LIQUID TOPICAL 20160810 UNAPPROVED DRUG OTHER Nanda Co., Ltd BUTYLENE GLYCOL .05 g/.9mL N 20181231 60764-021_edaeda14-140b-4616-b05b-5c601b2d349b 60764-021 HUMAN OTC DRUG 3CE TRIPLE SHADOW TIN TIN Titanium Dioxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .36 g/3.5g N 20181231 60764-022_bf20652b-7511-47c9-9f1b-dedd3e6bd764 60764-022 HUMAN OTC DRUG 3CE TRIPLE SHADOW BODY TO BODY Titanium Dioxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .42 g/3.5g N 20181231 60764-023_c90e5e07-c169-4b19-a2b3-683cd5d7744b 60764-023 HUMAN OTC DRUG 3CE TRIPLE SHADOW LEMME SEE Titanium Dioxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .3 g/3.5g N 20181231 60764-024_83ae0cda-6048-404b-962d-351b007bf6e2 60764-024 HUMAN OTC DRUG 3CE TRIPLE SHADOW MORE BROWN Titanium Dioxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .36 g/3.5g N 20181231 60764-025_e33bda00-75fa-499e-a6aa-b073339805a7 60764-025 HUMAN OTC DRUG 3CE TRIPLE SHADOW NO NONO Titanium Dioxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .23 g/3.5g N 20181231 60764-026_2bbf408a-1df3-4249-8904-f651c78def51 60764-026 HUMAN OTC DRUG 3CE LIP LACQUER SUPER CORAL Dimethicone LIPSTICK TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .76 g/6.4g N 20181231 60764-027_931cd71b-c7e9-4934-b33a-daed7693389b 60764-027 HUMAN OTC DRUG 3CE LIP LACQUER BACKSTAGE Dimethicone LIPSTICK TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .76 g/6.4g N 20181231 60764-028_4a9cafdf-d02f-477d-8444-032f6286aa24 60764-028 HUMAN OTC DRUG 3CE LIP LACQUER SHOW TIME Dimethicone LIPSTICK TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .76 g/6.4g N 20181231 60764-029_60f52c0a-6f2e-46a2-b636-7ac49bc66803 60764-029 HUMAN OTC DRUG 3CE LIP LACQUER XX ORANGE Dimethicone LIPSTICK TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .76 g/6.4g N 20181231 60764-030_563c6559-fa43-477c-95ac-da2104b0ac4b 60764-030 HUMAN OTC DRUG 3CE LIP LACQUER PINK BOOM Dimethicone LIPSTICK TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .76 g/6.4g N 20181231 60764-031_e6d4d67b-78c7-4fea-9720-c2c340e0d484 60764-031 HUMAN OTC DRUG 3CE LIP LACQUER BON BON Dimethicone LIPSTICK TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .76 g/6.4g N 20181231 60764-032_1cbaa641-e8c8-44a1-b14a-d121f7e575d5 60764-032 HUMAN OTC DRUG 3CE LIP LACQUER DIS CO Dimethicone LIPSTICK TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .76 g/6.4g N 20181231 60764-033_c1710f9b-b9ad-4b04-a97e-2169e10b5901 60764-033 HUMAN OTC DRUG 3CE LIP LACQUER HAWAIIAN PINK Dimethicone LIPSTICK TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .76 g/6.4g N 20181231 60764-034_595d3dda-928c-4f72-be49-a5a632283a39 60764-034 HUMAN OTC DRUG 3CE LIP LACQUER FEVER Dimethicone LIPSTICK TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .76 g/6.4g N 20181231 60764-035_d71561b6-b134-4f00-99e0-aa4f198122f9 60764-035 HUMAN OTC DRUG 3CE LIP LACQUER DAHLIA Dimethicone LIPSTICK TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .76 g/6.4g N 20181231 60764-036_9e821158-f3cb-4a83-b54b-3de646c86bd5 60764-036 HUMAN OTC DRUG 3CE SLIM EYEBROW PENCIL LIGHT BROWN Titanium Dioxide STICK TOPICAL 20160815 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .017 g/.085g N 20181231 60764-037_f07f52cc-bcfb-4086-b739-e527c3347a8f 60764-037 HUMAN OTC DRUG 3CE SLIM EYEBROW PENCIL REDDISH BROWN Titanium Dioxide STICK TOPICAL 20160815 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .005 g/.085g N 20181231 60764-038_b8b076ba-b803-4e4b-8e24-fd2fc9f05a5c 60764-038 HUMAN OTC DRUG 3CE SLIM EYEBROW PENCIL CHESTNUT BROWN Titanium Dioxide STICK TOPICAL 20160815 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .015 g/.085g N 20181231 60764-039_3e99552e-8b35-456b-8c50-af4f86e7a7b3 60764-039 HUMAN OTC DRUG 3CE SLIM EYEBROW PENCIL ASH BLACK Titanium Dioxide STICK TOPICAL 20160815 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .85 mg/.085g N 20181231 60764-040_c3f7109b-6d18-4b98-a091-be87801f0152 60764-040 HUMAN OTC DRUG 3CE CR EAMY WATER PROOF EYE LINER 01 CATS Cyclopentasiloxane LIQUID TOPICAL 20160810 UNAPPROVED DRUG OTHER Nanda Co., Ltd CYCLOMETHICONE 5 .16 g/.6g N 20181231 60764-041_1105daa9-b4e5-4789-a6ba-85022bcb6db0 60764-041 HUMAN OTC DRUG 3CE CR EAMY WATER PROOF EYE LINER 02 ZORRO Cyclopentasiloxane LIQUID TOPICAL 20160810 UNAPPROVED DRUG OTHER Nanda Co., Ltd CYCLOMETHICONE 5 .18 g/.6g N 20181231 60764-042_d90ecfb6-fa7f-4278-8afc-931c2ccce434 60764-042 HUMAN OTC DRUG 3CE CR EAMY WATER PROOF EYE LINER 13 CAFFEINE Cyclopentasiloxane LIQUID TOPICAL 20160810 UNAPPROVED DRUG OTHER Nanda Co., Ltd CYCLOMETHICONE 5 .2 g/.6g N 20181231 60764-043_7bd2d9a7-c26f-47db-9f43-73ca6bc81e7d 60764-043 HUMAN OTC DRUG 3CE CR EAMY WATER PROOF EYE LINER 08 LES MISERABLES Cyclopentasiloxane LIQUID TOPICAL 20160810 UNAPPROVED DRUG OTHER Nanda Co., Ltd CYCLOMETHICONE 5 .18 g/.6g N 20181231 60764-044_fa073208-72a3-4d4d-b859-e776a0c112a5 60764-044 HUMAN OTC DRUG 3CE LIQU ID EYE LINER BLACK Glycerin LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER Nanda Co., Ltd GLYCERIN .19 g/6.5g N 20181231 60764-045_2ceb650c-ed92-49c8-9ed0-23677185de0a 60764-045 HUMAN OTC DRUG 3CE LIQU ID EYE LINER BROWN Glycerin LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER Nanda Co., Ltd GLYCERIN .19 g/6.5g N 20181231 60764-046_4e94e80e-9f48-4030-aeac-ace2bb29b071 60764-046 HUMAN OTC DRUG 3CE LIP COLOR 902 ROSE BREATH Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .13 g/3.5g N 20181231 60764-047_5d59fc95-3ac9-42b6-9584-bbd31c13aa94 60764-047 HUMAN OTC DRUG 3CE LIP COLOR 903 GLASS ROSY Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .014 g/3.5g N 20181231 60764-048_0f5c12fe-8e58-451b-adad-31dc38229c27 60764-048 HUMAN OTC DRUG 3CE LIP COLOR 904 GLASS BERRY Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .01 g/3.5g N 20181231 60764-049_41e2e8e0-52f9-41e3-9f58-7352ba3fe643 60764-049 HUMAN OTC DRUG 3CE LIP COLOR 905 GONE BAD Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .01 g/3.5g N 20181231 60764-050_9f5df684-5b99-4010-bed1-e6a1e5792574 60764-050 HUMAN OTC DRUG 3CE LIP COLOR 906 BITE IT Triethylhexanoin LIPSTICK TOPICAL 20160801 UNAPPROVED DRUG OTHER Nanda Co., Ltd TRIETHYLHEXANOIN .31 g/3.5g N 20181231 60764-051_6a77f89f-d9d8-437e-83ea-a124cda5b08c 60764-051 HUMAN OTC DRUG 3CE LIP COLOR 309 CELEBRITY Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .13 g/3.5g N 20181231 60764-052_36413e56-f599-4f34-93d5-1bb352a85299 60764-052 HUMAN OTC DRUG 3CE LIP COLOR 806 DUSTY CORAL Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .29 g/3.5g N 20181231 60764-053_82c643df-d3b7-48eb-9960-7f473d557bdb 60764-053 HUMAN OTC DRUG 3CE LIP COLOR 807 HYPNOTIC Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .14 g/3.5g N 20181231 60764-054_f6850ece-7f95-4c4b-9b7a-62699dda6bb0 60764-054 HUMAN OTC DRUG 3CE LIP COLOR 803 CLASSIC ROSY Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .1 g/3.5g N 20181231 60764-055_342abaf3-9b16-4e05-8091-a7912748c8f1 60764-055 HUMAN OTC DRUG 3CE LIP COLOR 804 STAY BY ME Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .15 g/3.5g N 20181231 60764-056_1602fb36-9cfd-46cd-8ed9-c075c415a0e5 60764-056 HUMAN OTC DRUG 3CE LIP COLOR 805 R 19 Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .1 g/3.5g N 20181231 60764-057_1c99bf13-96a0-4815-b811-be531d395552 60764-057 HUMAN OTC DRUG 3CE PINK IM GOOD MASCARA Cyclopentasiloxane LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER Nanda Co., Ltd CYCLOMETHICONE 5 .17 g/8.5g N 20181231 60764-058_fcc2bb88-f26c-4afa-b9b8-fa24491efd9d 60764-058 HUMAN OTC DRUG 3CE DUO COLOR FACE BLUSH MAKE ME BLUSH Titanium Dioxide POWDER TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .07 g/5g N 20181231 60764-059_7be51a56-aa3a-48a7-b081-5dc5d984c5e8 60764-059 HUMAN OTC DRUG 3CE DUO COLOR FACE BLUSH CREME DE VIOLETTE Titanium Dioxide POWDER TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .28 g/5g N 20181231 60764-060_a6fb2a23-0c5a-44a9-973c-f29afdd5f6d7 60764-060 HUMAN OTC DRUG 3CE DUO COLOR FACE BLUSH MISS FLOWER Titanium Dioxide POWDER TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .31 g/5g N 20181231 60764-061_b8c9cea5-61eb-4f54-a014-5af0882c65c5 60764-061 HUMAN OTC DRUG 3CE DUO COLOR FACE BLUSH RETRO DRIVE Titanium Dioxide POWDER TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .12 g/5g N 20181231 60764-062_6c6e5465-e506-4607-be10-b7f3a496e55e 60764-062 HUMAN OTC DRUG 3CE DUO COLOR FACE BLUSH PEACH CRUSH Titanium Dioxide POWDER TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .37 g/5g N 20181231 60764-063_12364afe-25d3-4753-ab51-7b358b5c705c 60764-063 HUMAN OTC DRUG 3CE EYE SHADOW PALETTE UP CLOSE Titanium Dioxide POWDER TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .52 g/8g N 20181231 60764-064_13207fa1-1a33-4d60-a434-51302a6e18ce 60764-064 HUMAN OTC DRUG 3CE EYE SHADOW PALETTE BITTER SWEET Titanium Dioxide POWDER TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .67 g/8g N 20181231 60764-065_6644c733-1150-4e54-9816-074ec3939957 60764-065 HUMAN OTC DRUG 3CE EYE SHADOW PALETTE SADDLE Titanium Dioxide POWDER TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .68 g/8g N 20181231 60764-066_17a183cb-427e-4b71-b09d-15bb331c4e67 60764-066 HUMAN OTC DRUG 3CE EYE SHADOW PALETTE SIENNA Titanium Dioxide POWDER TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .47 g/8g N 20181231 60764-067_f41d11f5-7673-4e87-98b5-bce4a757ca0e 60764-067 HUMAN OTC DRUG 3CE LIP COLOR 204 COME TO ME Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .02 g/3.5g N 20181231 60764-068_63113d70-5afb-4aba-98ed-89485dc62188 60764-068 HUMAN OTC DRUG 3CE LIP COLOR 308 PINK JAM Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .12 g/3.5g N 20181231 60764-069_e8a91fd2-5b30-4e48-af89-1de2871cb9af 60764-069 HUMAN OTC DRUG 3CE LIP COLOR 401 SCANDAL Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .05 g/3.5g N 20181231 60764-070_f949c424-9919-4e5c-9cb6-f369c6a84709 60764-070 HUMAN OTC DRUG 3CE LIP COLOR 402 FUCHSIA Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .17 g/3.5g N 20181231 60764-071_a024db4d-d212-4190-9699-d1469524dd98 60764-071 HUMAN OTC DRUG 3CE LIP COLOR 408 CHU CHU Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .17 g/3.5g N 20181231 60764-072_4f016b63-6fdd-47c1-9cfa-b4d8df5a5fe3 60764-072 HUMAN OTC DRUG 3CE LIP COLOR 409 KISS WOO Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .04 g/3.5g N 20181231 60764-073_a5b5b571-16fe-4238-a267-0c4d0f44e9de 60764-073 HUMAN OTC DRUG 3CE LIP COLOR 501 BELLA Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .07 g/3.5g N 20181231 60764-074_a0a598b5-9602-49a3-9ad9-088fae19ab73 60764-074 HUMAN OTC DRUG 3CE LIP COLOR 503 GLASS HOT PINK Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .02 g/3.5g N 20181231 60764-075_0413c58a-61ad-4836-b28d-9a9fa9d8f024 60764-075 HUMAN OTC DRUG 3CE LIP COLOR 506 DAILY LADY Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .12 g/3.5g N 20181231 60764-076_ef99ead3-ab63-41bf-bda4-201469e663e4 60764-076 HUMAN OTC DRUG 3CE LIP COLOR 507 LALA Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .15 g/3.5g N 20181231 60764-077_4f08b501-4588-41a0-a23d-40cac960e494 60764-077 HUMAN OTC DRUG 3CE LIP COLOR 508 SWING SWING Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .15 g/3.5g N 20181231 60764-078_77e5a8ef-562e-4f05-b82b-5e106c14a2b4 60764-078 HUMAN OTC DRUG 3CE LIP COLOR 601 DEEP KISSER Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .04 g/3.5g N 20181231 60764-079_5aa52a82-dc61-4799-9e8c-f532fe1a0857 60764-079 HUMAN OTC DRUG 3CE LIP COLOR 602 V Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .1 g/3.5g N 20181231 60764-080_dc1e82be-a3c8-44fc-b07e-e9125652f3a3 60764-080 HUMAN OTC DRUG 3CE LIP COLOR 609 JAMMER Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .01 g/3.5g N 20181231 60764-081_826f2a31-0bc6-4f72-ba1a-b9a026bb72fe 60764-081 HUMAN OTC DRUG 3CE LIP COLOR 701 RONDO Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .01 g/3.5g N 20181231 60764-082_811df650-e56b-4179-9873-b115225d14df 60764-082 HUMAN OTC DRUG 3CE LIP COLOR 704 CURTAIN CALL Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .1 g/3.5g N 20181231 60764-083_815df262-67ee-4c89-851d-a50a31c5b80b 60764-083 HUMAN OTC DRUG 3CE LIP COLOR 706 SWEET IMPACT Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .2 g/3.5g N 20181231 60764-084_4828ff4f-8241-49dc-b0ce-9f8aa2126ac3 60764-084 HUMAN OTC DRUG 3CE MATTE LIP CRAYON DUBIOUS Dimethicone LIPSTICK TOPICAL 20160810 UNAPPROVED DRUG OTHER Nanda Co., Ltd DIMETHICONE .006 g/g N 20181231 60764-085_03dbfa15-c279-41ac-ae22-8b3bc3d96aaa 60764-085 HUMAN OTC DRUG 3CE MATTE LIP CRAYON RUM Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .005 g/g N 20181231 60764-086_5eafbb9c-558e-4bd7-8f8f-53064f3c1f43 60764-086 HUMAN OTC DRUG 3CE MATTE LIP CRAYON BLUSHED Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .11 g/g N 20181231 60764-087_c5b8a1f6-42f9-4400-8168-403ff9f9a810 60764-087 HUMAN OTC DRUG 3CE MATTE LIP CRAYON SPEAK LOW Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .11 g/g N 20181231 60764-088_590c8e8b-658b-4f4b-bc74-eb6b290da20b 60764-088 HUMAN OTC DRUG 3CE MATTE LIP CRAYON AIRY RED Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .005 g/g N 20181231 60764-089_e08ed55a-247d-4d6d-93a6-746bd63f3b00 60764-089 HUMAN OTC DRUG 3CE MATTE LIP CRAYON TERRIFIC Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .081 g/g N 20181231 60764-090_268ed806-e18d-4d13-ac73-5e1604ff70ea 60764-090 HUMAN OTC DRUG 3CE MATTE LIP CRAYON PEEKABOO Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .097 g/g N 20181231 60764-091_82e406de-9262-4886-8d67-06d1fc141a69 60764-091 HUMAN OTC DRUG 3CE MATTE LIP CRAYON PINK LEAVES Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .107 g/g N 20181231 60764-092_4fa53187-db04-49f3-8a6f-eaa6725b8e8c 60764-092 HUMAN OTC DRUG 3CE MATTE LIP CRAYON HOTLINE Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .03 g/g N 20181231 60764-093_dcd31c8b-2cc7-4d20-9a65-854f03e2fd4e 60764-093 HUMAN OTC DRUG 3CE MATTE LIP CRAYON HEAVEN WAY Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .129 g/g N 20181231 60764-094_feb0ab11-6842-4f6d-988e-566ec149c810 60764-094 HUMAN OTC DRUG 3CE EYEBROW MASCARA BLONDIE GOLD Titanium Dioxide LIQUID TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .16 g/6g N 20181231 60764-095_b6e3d69e-042c-4b49-8343-a987d80a9596 60764-095 HUMAN OTC DRUG 3CE EYEBROW MASCARA BROWN Titanium Dioxide LIQUID TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .06 g/6g N 20181231 60764-096_44449e50-4350-49c8-b4f1-393298c09cd2 60764-096 HUMAN OTC DRUG 3CE EYEBROW MASCARA GOLD BROWN Titanium Dioxide LIQUID TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .19 g/6g N 20181231 60764-097_57ef3848-6b58-45e6-9b29-486afd865f2b 60764-097 HUMAN OTC DRUG 3CE EYEBROW MASCARA RED BROWN Titanium Dioxide LIQUID TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .06 g/6g N 20181231 60764-098_53f10a8e-24a8-41c4-85b6-9cd8685eab41 60764-098 HUMAN OTC DRUG 3CE FULL COVER CONCEALER 001 Titanium Dioxide LIQUID TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .65 g/5mL N 20181231 60764-099_26e1feab-fd0f-41c1-9894-60caf7c61f42 60764-099 HUMAN OTC DRUG 3CE FULL COVER CONCEALER 002 Titanium Dioxide LIQUID TOPICAL 20160820 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .65 g/5mL N 20181231 60764-100_bcd257e1-0217-44f6-8ad7-f5398da69f9c 60764-100 HUMAN OTC DRUG 3CE DRAWING LIP PEN BEWARE Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .08 g/1.1g N 20181231 60764-101_e2203b0b-bc65-4299-aef3-f47004d5b849 60764-101 HUMAN OTC DRUG 3CE DRAWING LIP PEN BORN RED Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .01 g/1.1g N 20181231 60764-102_bd05c8c4-4f48-4876-b5e5-7057bfa05a5a 60764-102 HUMAN OTC DRUG 3CE DRAWING LIP PEN BUTTER PINK Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .26 g/1.1g N 20181231 60764-103_b3d32f84-bda2-4da9-b7de-44c5071bb7ed 60764-103 HUMAN OTC DRUG 3CE DRAWING LIP PEN CRUSH ON YOU Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .08 g/1.1g N 20181231 60764-104_78bf34be-0e6f-458a-8d66-fa9d1923efcd 60764-104 HUMAN OTC DRUG 3CE DRAWING LIP PEN ENDEAR Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .23 g/1.1g N 20181231 60764-105_33b04067-63ec-4c2f-8b35-8143beb8513a 60764-105 HUMAN OTC DRUG 3CE DRAWING LIP PEN LITTLE MORE Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .22 g/1.1g N 20181231 60764-106_f640f40f-117c-4821-8edb-fdea8400e66d 60764-106 HUMAN OTC DRUG 3CE DRAWING LIP PEN MAYHAP Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .26 g/1.1g N 20181231 60764-107_ec4993de-9544-4ddc-a327-2a1673d53380 60764-107 HUMAN OTC DRUG 3CE DRAWING LIP PEN NEED Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .26 g/1.1g N 20181231 60764-108_45622ddb-96ea-4593-9309-b6e6e6f5effd 60764-108 HUMAN OTC DRUG 3CE DRAWING LIP SLOE GIN Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .04 g/1.1g N 20181231 60764-109_3be2a023-a85d-4bf0-be5d-e54112327119 60764-109 HUMAN OTC DRUG 3CE DRAWING LIP WILLOWY Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .22 g/1.1g N 20181231 60764-110_85313776-f09c-444a-9bd3-1c0c825fdafb 60764-110 HUMAN OTC DRUG 3CE DRAWING LIP YOU GOT ME Titanium Dioxide LIPSTICK TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .08 g/1.1g N 20181231 60764-111_3bcebd30-c36e-403c-9069-efdffd38c139 60764-111 HUMAN OTC DRUG 3CE DRAWING LIP CHILLING Lanolin LIPSTICK TOPICAL 20160801 UNAPPROVED DRUG OTHER Nanda Co., Ltd LANOLIN .02 g/1.1g N 20181231 60764-112_25658489-9fa6-49ce-870a-a6fd3e18e31b 60764-112 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 01 PICK ME UP Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .02 g/4.5g N 20181231 60764-113_394ff5e4-5513-4246-89e5-aec54b750b1b 60764-113 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 03 ZOOM IN Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .11 g/4.5g N 20181231 60764-114_7dedd50e-b4f3-41bd-8048-66c93275faed 60764-114 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 04 JOYCE Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .15 g/4.5g N 20181231 60764-115_65249071-11f0-4fe9-83fb-4d84edf9bbcd 60764-115 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 05 DAZZLING Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .16 g/4.5g N 20181231 60764-116_da23b42c-d66f-4ec7-a5f9-e1de22ad2b53 60764-116 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 06 JAZZY PINK Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .17 g/4.5g N 20181231 60764-117_eb89d7fc-1f77-4e41-9733-c8859bd2e79e 60764-117 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 08 LADI DADI Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .18 g/4.5g N 20181231 60764-118_48544af1-479b-47ee-a5db-df8149541bf0 60764-118 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 09 KI TSCH BIKER Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .03 g/4.5g N 20181231 60764-119_6bffecb7-0a9d-4904-94ec-442f4414040a 60764-119 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 10 ROLLER COASTER Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .22 g/4.5g N 20181231 60764-120_c5ae504f-9b0e-44fc-afcb-e0eaea3f29a0 60764-120 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 12 ME ME Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .13 g/4.5g N 20181231 60764-121_e93a2bd5-4dce-42ff-b4fe-45ed7d945e00 60764-121 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 13 VEG AS NIGHT Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .03 g/4.5g N 20181231 60764-122_b9d72667-f8bd-4c8a-b64f-a573a93b29b8 60764-122 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 14 LOLLIPOP Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .18 g/4.5g N 20181231 60764-123_08a6bdec-ab73-42f6-bdbf-3a3ee5ac56eb 60764-123 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 15 BELOVED Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .18 g/4.5g N 20181231 60764-124_8d0eb702-a012-4e66-967c-f44f106b2fe5 60764-124 HUMAN OTC DRUG 3CE CRE AMY LIP COLOR 16 GIDDY UP Titanium Dioxide LIPSTICK TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE .09 g/4.5g N 20181231 60764-125_2e36a659-fad4-4951-8e33-052eec2d15f2 60764-125 HUMAN OTC DRUG 3CE WHITE MILK CREA M Dimethicone CREAM TOPICAL 20160820 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .75 g/50mL N 20181231 60764-126_0c6c8a9d-0560-49ba-acd4-bd9790965080 60764-126 HUMAN OTC DRUG 3CE SKIN TONE CONTROL PRIMER ICE VANILLA Dimethicone CREAM TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .93 g/30mL N 20181231 60764-127_5cc3098e-a569-4d3d-b5ba-4f918c420058 60764-127 HUMAN OTC DRUG 3CE SKIN TONE CONTROL PRIMER MILD PEACH Dimethicone CREAM TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .93 g/30mL N 20181231 60764-128_9f2eb7a8-4e2f-474f-bb50-7c4c41997f7a 60764-128 HUMAN OTC DRUG 3CE SKIN TONE CONTROL PRIMER PURE VIOLET Dimethicone CREAM TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Nanda Co., Ltd DIMETHICONE .93 g/30mL N 20181231 60764-129_445175f7-b886-473d-b5b4-1b3ff3fddb75 60764-129 HUMAN OTC DRUG 3CE Tinted moisture cushion CC 001 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.06; .8; .48 g/12g; g/12g; g/12g N 20181231 60764-130_4c9618ae-2661-475d-81ee-0eace329912d 60764-130 HUMAN OTC DRUG 3CE Tinted moisture cushion CC 002 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.04; .8; .48 g/12g; g/12g; g/12g N 20181231 60764-131_418e77e4-0c9a-4f59-9043-4b4840891ddc 60764-131 HUMAN OTC DRUG 3CE Fitting Cushion Foundation 001 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.69; .8; .48 g/12g; g/12g; g/12g N 20181231 60764-132_2ca9c6c5-0a22-4d79-92ab-c02cf530e471 60764-132 HUMAN OTC DRUG 3CE Fitting Cushion Foundation 002 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20160810 OTC MONOGRAPH NOT FINAL part352 Nanda Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.74; .8; .48 g/12g; g/12g; g/12g N 20181231 60764-133_320228da-ad91-4f88-8a28-459e1c797a76 60764-133 HUMAN OTC DRUG 3CE FIXER AND MASCARA BLACK Allantoin LIQUID TOPICAL 20160820 UNAPPROVED DRUG OTHER Nanda Co., Ltd ALLANTOIN .006 g/6.6g N 20181231 60764-134_a0f8a295-ea3e-4c1d-bb41-1be19b835afd 60764-134 HUMAN OTC DRUG 3CE FIXER AND MASCARA BROWN Allantoin LIQUID TOPICAL 20160820 UNAPPROVED DRUG OTHER Nanda Co., Ltd ALLANTOIN .006 g/6.6g N 20181231 60768-001_7172de3d-c4db-41ba-863f-7e67839c089c 60768-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130919 UNAPPROVED MEDICAL GAS Gage Lucky 13 LLC dba Tecumseh Oxygen & Medical Supply OXYGEN 99 L/100L E 20171231 60778-010_a81dcd31-a562-47ba-89e5-f9a5cfdcf0c1 60778-010 HUMAN OTC DRUG Lycoris Rubus brightening BB SPF40 PA Plus Plus OCTINOXATE, Titanium dioxide, Zinc oxide CREAM TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Lycoris Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 2; 2 mg/40mL; mg/40mL; mg/40mL E 20171231 60778-020_404b5431-8780-4559-9e77-4b6a2f0c7472 60778-020 HUMAN OTC DRUG Lycoris rubus whitening moisturizing Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 Lycoris Co., Ltd. ALLANTOIN .25 mg/50mL E 20171231 60778-030_ec63cd50-1f4f-48aa-9aae-51df78b3c553 60778-030 HUMAN OTC DRUG Lycoris rubus whitening Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 Lycoris Co., Ltd. ALLANTOIN .25 mg/50mL E 20171231 60778-040_7b76a3f7-baa7-456b-9236-46ff4a385473 60778-040 HUMAN OTC DRUG Lycoris RUBUS Whitening Fluid Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 Lycoris Co., Ltd. ALLANTOIN .67 mg/135mL E 20171231 60779-001_6ae99f32-c439-4023-ba35-4cde3418c389 60779-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140101 NDA NDA205712 Latex Welding Supply Inc. dba ARC-La-Tec Welding Supply OXYGEN 99 L/100L N 20181231 60781-1001_9c5c4338-e3ba-4e1d-8853-6eb60e6a4181 60781-1001 HUMAN OTC DRUG THINKSPORT sunscreen SPF 50 zinc oxide LOTION TOPICAL 20110101 OTC MONOGRAPH FINAL part352 thinkOperations,LLC ZINC OXIDE 200 mg/mL N 20181231 60781-1002_17d27cc3-9334-4573-8b96-560d7b4d9668 60781-1002 HUMAN OTC DRUG THINKSPORT Kids sunscreen SPF 50 zinc oxide LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part352 thinkOperations,LLC ZINC OXIDE 200 mg/mL E 20171231 60781-1003_a9f48ad2-744e-4240-b95d-2982985d9ff9 60781-1003 HUMAN OTC DRUG THINKBABY Baby Sunscreen SPF 50 zinc oxide LOTION TOPICAL 20130814 OTC MONOGRAPH FINAL part352 thinkOperations,LLC ZINC OXIDE 200 mg/mL N 20181231 60781-1010_7c67a6a6-9d6a-4bb7-9954-e6b6ea3c00e4 60781-1010 HUMAN OTC DRUG Thinksport Thinksun Sunscreen SPF 30 zinc oxide LOTION TOPICAL 20170101 OTC MONOGRAPH FINAL part352 thinkOperations,LLC ZINC OXIDE 200 mg/mL N 20181231 60781-2003_88f12afb-41d2-4d60-81ab-b76e98946f97 60781-2003 HUMAN OTC DRUG Thinkbaby Sunscreen SPF 30 zinc oxide STICK TOPICAL 20170101 OTC MONOGRAPH FINAL part352 thinkOperations,LLC ZINC OXIDE 200 ug/g N 20181231 60782-000_bc35985e-98b8-489e-bf73-7b6f3bc466de 60782-000 HUMAN OTC DRUG Renove ROYAL PERFECT BB SPF 30 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20131003 OTC MONOGRAPH NOT FINAL part352 YS Health Corp. TITANIUM DIOXIDE; OCTINOXATE 80; 30 mg/mL; mg/mL E 20171231 60782-001_9da7f217-7080-4886-a74f-4ad45d0a7c36 60782-001 HUMAN OTC DRUG Renove ROYAL PERFECT HAND Broad Spectrum SPF 15 ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, AVOBENZONE CREAM TOPICAL 20131205 OTC MONOGRAPH NOT FINAL part352 YS Health Corp. OCTINOXATE; OCTISALATE; AVOBENZONE 68; 42; 10 mg/g; mg/g; mg/g E 20171231 60782-002_299bf476-fa58-47eb-e054-00144ff8d46c 60782-002 HUMAN OTC DRUG Renove Royal Perfect Color Control Cushion SPF 37 / PA TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150804 OTC MONOGRAPH NOT FINAL part352 Y.S. Health Corp. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 81.4; 68.6; 40 mg/mL; mg/mL; mg/mL E 20171231 60782-003_4a2b9775-439f-2ee5-e054-00144ff8d46c 60782-003 HUMAN OTC DRUG Renove UV Shield Broad Spectrum SPF 50 Avobenzone, Octinoxate sunscreen CREAM TOPICAL 20150804 OTC MONOGRAPH NOT FINAL part352 Y.S. Health Corp. OCTINOXATE; AVOBENZONE 6.2; 3 g/10mL; g/10mL N 20181231 60793-104_acfeef88-87bf-4408-9b40-c1fc5b757418 60793-104 HUMAN PRESCRIPTION DRUG TAPAZOLE methimazole TABLET ORAL 20000331 ANDA ANDA040320 Pfizer Laboratories Div Pfizer Inc METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 60793-105_acfeef88-87bf-4408-9b40-c1fc5b757418 60793-105 HUMAN PRESCRIPTION DRUG TAPAZOLE methimazole TABLET ORAL 20000331 ANDA ANDA040320 Pfizer Laboratories Div Pfizer Inc METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 60793-115_a0a9703d-e476-4207-b0e6-3348d68c2f60 60793-115 HUMAN PRESCRIPTION DRUG Cytomel liothyronine sodium TABLET ORAL 19560508 NDA NDA010379 Pfizer Laboratories Div Pfizer Inc LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 60793-116_a0a9703d-e476-4207-b0e6-3348d68c2f60 60793-116 HUMAN PRESCRIPTION DRUG Cytomel liothyronine sodium TABLET ORAL 19560508 NDA NDA010379 Pfizer Laboratories Div Pfizer Inc LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 60793-117_a0a9703d-e476-4207-b0e6-3348d68c2f60 60793-117 HUMAN PRESCRIPTION DRUG Cytomel liothyronine sodium TABLET ORAL 19560508 NDA NDA010379 Pfizer Laboratories Div Pfizer Inc LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 60793-130_08835b3b-6dc8-495b-bddc-6a2a814639b8 60793-130 HUMAN PRESCRIPTION DRUG PENICILLIN G PROCAINE penicillin g procaine INJECTION, SUSPENSION INTRAMUSCULAR 19480426 ANDA ANDA060101 Pfizer Laboratories Div Pfizer Inc PENICILLIN G PROCAINE 600000 [iU]/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 60793-131_08835b3b-6dc8-495b-bddc-6a2a814639b8 60793-131 HUMAN PRESCRIPTION DRUG PENICILLIN G PROCAINE penicillin g procaine INJECTION, SUSPENSION INTRAMUSCULAR 19480426 ANDA ANDA060101 Pfizer Laboratories Div Pfizer Inc PENICILLIN G PROCAINE 1200000 [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 60793-136_a7d1eb29-d708-4a50-a7e4-794819983411 60793-136 HUMAN PRESCRIPTION DRUG SKELAXIN metaxalone TABLET ORAL 20020830 NDA NDA013217 Pfizer Laboratories Div Pfizer Inc METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20191231 60793-145_dcfb1511-dbf5-4346-9067-6e98cdab6473 60793-145 HUMAN PRESCRIPTION DRUG Sonata zaleplon CAPSULE ORAL 19990813 NDA NDA020859 Pfizer Laboratories Div Pfizer Inc ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 60793-146_dcfb1511-dbf5-4346-9067-6e98cdab6473 60793-146 HUMAN PRESCRIPTION DRUG Sonata zaleplon CAPSULE ORAL 19990813 NDA NDA020859 Pfizer Laboratories Div Pfizer Inc ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 60793-205_c5454d11-7f89-47b9-a30c-00ff8b3289a2 60793-205 PLASMA DERIVATIVE THROMBIN-JMI thrombin, topical (bovine) KIT 19950224 BLA BLA102865 Pfizer Laboratories Div Pfizer Inc N 20181231 60793-215_c5454d11-7f89-47b9-a30c-00ff8b3289a2 60793-215 PLASMA DERIVATIVE THROMBIN-JMI thrombin, topical (bovine) KIT 19950224 BLA BLA102865 Pfizer Laboratories Div Pfizer Inc N 20181231 60793-217_c5454d11-7f89-47b9-a30c-00ff8b3289a2 60793-217 PLASMA DERIVATIVE THROMBIN-JMI thrombin, topical (bovine) KIT 19950224 BLA BLA102865 Pfizer Laboratories Div Pfizer Inc N 20181231 60793-283_6a0ac6f2-a99a-4985-92ea-9fd16b37c15c 60793-283 HUMAN PRESCRIPTION DRUG CORZIDE nadolol and bendroflumethiazide TABLET ORAL 19830525 NDA NDA018647 Pfizer Laboratories Div Pfizer Inc NADOLOL; BENDROFLUMETHIAZIDE 40; 5 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60793-284_6a0ac6f2-a99a-4985-92ea-9fd16b37c15c 60793-284 HUMAN PRESCRIPTION DRUG CORZIDE nadolol and bendroflumethiazide TABLET ORAL 19830525 NDA NDA018647 Pfizer Laboratories Div Pfizer Inc NADOLOL; BENDROFLUMETHIAZIDE 80; 5 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 60793-411_932ce86a-203b-4389-be4a-7cb609d1739c 60793-411 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20080114 NDA NDA021234 Pfizer, Inc. DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 60793-430_22852274-22cf-4619-9980-4ae3bc0ffdc6 60793-430 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 20; .8 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CII N 20181231 60793-431_22852274-22cf-4619-9980-4ae3bc0ffdc6 60793-431 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 30; 1.2 mg/1; mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60793-433_22852274-22cf-4619-9980-4ae3bc0ffdc6 60793-433 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 50; 2 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CII N 20181231 60793-434_22852274-22cf-4619-9980-4ae3bc0ffdc6 60793-434 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 60; 2.4 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CII N 20181231 60793-435_22852274-22cf-4619-9980-4ae3bc0ffdc6 60793-435 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 80; 3.2 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CII N 20181231 60793-437_22852274-22cf-4619-9980-4ae3bc0ffdc6 60793-437 HUMAN PRESCRIPTION DRUG EMBEDA MORPHINE SULFATE and NALTREXONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20090813 NDA NDA022321 Pfizer Laboratories Div Pfizer Inc MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE 100; 4 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CII N 20181231 60793-525_62a67736-7354-4eec-8c3e-1f5743594f21 60793-525 HUMAN PRESCRIPTION DRUG OXECTA OXYCODONE HYDROCHLORIDE TABLET ORAL 20110617 NDA NDA202080 Pfizer Laboratories Div Pfizer Inc OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60793-526_62a67736-7354-4eec-8c3e-1f5743594f21 60793-526 HUMAN PRESCRIPTION DRUG OXECTA OXYCODONE HYDROCHLORIDE TABLET ORAL 20110617 NDA NDA202080 Pfizer Laboratories Div Pfizer Inc OXYCODONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60793-600_8394da9c-0c63-4c21-99f5-7a1288bd57c9 60793-600 HUMAN PRESCRIPTION DRUG BICILLIN CR penicillin G benzathine and penicillin G procaine INJECTION, SUSPENSION INTRAMUSCULAR 19530518 NDA NDA050138 Pfizer Laboratories Div Pfizer Inc PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 600000; 600000 [iU]/2mL; [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 60793-601_8394da9c-0c63-4c21-99f5-7a1288bd57c9 60793-601 HUMAN PRESCRIPTION DRUG BICILLIN CR penicillin G benzathine and penicillin G procaine INJECTION, SUSPENSION INTRAMUSCULAR 19530518 NDA NDA050138 Pfizer Laboratories Div Pfizer Inc PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 600000; 600000 [iU]/2mL; [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 60793-602_ca19ac37-dc5d-434e-8d4e-c2a9112df5ca 60793-602 HUMAN PRESCRIPTION DRUG BICILLIN C-R 900/300 penicillin G benzathine and penicillin G procaine INJECTION, SUSPENSION INTRAMUSCULAR 19530518 NDA NDA050138 Pfizer Laboratories Div Pfizer Inc PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 900000; 300000 [iU]/2mL; [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 60793-700_88d5a040-8df7-4d76-b456-90892b9d44d1 60793-700 HUMAN PRESCRIPTION DRUG BICILLIN L-A penicillin G benzathine INJECTION, SUSPENSION INTRAMUSCULAR 19520627 NDA NDA050141 Pfizer Laboratories Div Pfizer Inc PENICILLIN G BENZATHINE 600000 [iU]/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 60793-701_88d5a040-8df7-4d76-b456-90892b9d44d1 60793-701 HUMAN PRESCRIPTION DRUG BICILLIN L-A penicillin G benzathine INJECTION, SUSPENSION INTRAMUSCULAR 19520627 NDA NDA050141 Pfizer Laboratories Div Pfizer Inc PENICILLIN G BENZATHINE 1200000 [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 60793-702_88d5a040-8df7-4d76-b456-90892b9d44d1 60793-702 HUMAN PRESCRIPTION DRUG BICILLIN L-A penicillin G benzathine INJECTION, SUSPENSION INTRAMUSCULAR 19520627 NDA NDA050141 Pfizer Laboratories Div Pfizer Inc PENICILLIN G BENZATHINE 2400000 [iU]/4mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 60793-705_c5454d11-7f89-47b9-a30c-00ff8b3289a2 60793-705 PLASMA DERIVATIVE THROMBIN-JMI thrombin, topical (bovine) KIT 19950224 BLA BLA102865 Pfizer Laboratories Div Pfizer Inc N 20181231 60793-800_15c2b40b-81b9-404a-9d49-b30498c8d3ef 60793-800 HUMAN PRESCRIPTION DRUG CORGARD nadolol TABLET ORAL 19791210 NDA NDA018063 Pfizer Laboratories Div Pfizer Inc NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 60793-801_15c2b40b-81b9-404a-9d49-b30498c8d3ef 60793-801 HUMAN PRESCRIPTION DRUG CORGARD nadolol TABLET ORAL 19791210 NDA NDA018063 Pfizer Laboratories Div Pfizer Inc NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 60793-802_15c2b40b-81b9-404a-9d49-b30498c8d3ef 60793-802 HUMAN PRESCRIPTION DRUG CORGARD nadolol TABLET ORAL 19791210 NDA NDA018063 Pfizer Laboratories Div Pfizer Inc NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 60793-850_ce7269f5-5ddd-49ec-b3a6-0f3a6870e066 60793-850 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60793-851_ce7269f5-5ddd-49ec-b3a6-0f3a6870e066 60793-851 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60793-852_ce7269f5-5ddd-49ec-b3a6-0f3a6870e066 60793-852 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60793-853_ce7269f5-5ddd-49ec-b3a6-0f3a6870e066 60793-853 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60793-854_ce7269f5-5ddd-49ec-b3a6-0f3a6870e066 60793-854 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60793-855_ce7269f5-5ddd-49ec-b3a6-0f3a6870e066 60793-855 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60793-856_ce7269f5-5ddd-49ec-b3a6-0f3a6870e066 60793-856 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60793-857_ce7269f5-5ddd-49ec-b3a6-0f3a6870e066 60793-857 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60793-858_ce7269f5-5ddd-49ec-b3a6-0f3a6870e066 60793-858 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60793-859_ce7269f5-5ddd-49ec-b3a6-0f3a6870e066 60793-859 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60793-860_ce7269f5-5ddd-49ec-b3a6-0f3a6870e066 60793-860 HUMAN PRESCRIPTION DRUG LEVOXYL levothyroxine sodium TABLET ORAL 20010525 NDA NDA021301 Pfizer Laboratories Div Pfizer Inc LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60809-801_e46925f2-7335-435e-8fe0-f4455fd01c74 60809-801 HUMAN PRESCRIPTION DRUG Krystexxa pegloticase INJECTION, SOLUTION INTRAVENOUS 20100914 BLA BLA125293 Horizon Pharma Inc. PEGLOTICASE 8 mg/mL Urate Oxidase [Chemical/Ingredient],Uric Acid-specific Enzyme [EPC] N 20181231 60840-0100_a8ad7c28-7e88-8547-95c3-c840a6b2fd5b 60840-0100 HUMAN OTC DRUG Libera Tos Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20131101 OTC MONOGRAPH FINAL part341 RockHealth, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 60840-0200_d91b4832-d7d8-4485-8491-714e3de35e81 60840-0200 HUMAN OTC DRUG Libera Tos Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20131101 OTC MONOGRAPH FINAL part341 RockHealth, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 60840-0300_49130127-464d-494f-3241-0bafe28af2df 60840-0300 HUMAN OTC DRUG Libera Tos Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20131101 OTC MONOGRAPH FINAL part341 RockHealth, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 75 mg/5mL; mg/5mL E 20171231 60842-021_1ad0b4da-c2df-4c1a-999e-16728618fded 60842-021 HUMAN PRESCRIPTION DRUG Auvi-Q epinephrine INJECTION, SOLUTION INTRAMUSCULAR 20171117 NDA NDA201739 kaleo, Inc EPINEPHRINE .1 mg/.1mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 60842-022_1ad0b4da-c2df-4c1a-999e-16728618fded 60842-022 HUMAN PRESCRIPTION DRUG Auvi-Q epinephrine INJECTION, SOLUTION INTRAMUSCULAR 20121115 NDA NDA201739 kaleo, Inc EPINEPHRINE .15 mg/.15mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 60842-023_1ad0b4da-c2df-4c1a-999e-16728618fded 60842-023 HUMAN PRESCRIPTION DRUG Auvi-Q epinephrine INJECTION, SOLUTION INTRAMUSCULAR 20121115 NDA NDA201739 kaleo, Inc EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 60842-030_88ad1aa9-2732-4e5f-a854-80945cbf1d24 60842-030 HUMAN PRESCRIPTION DRUG Evzio naloxone hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20140403 20180531 NDA NDA205787 kaleo, Inc. NALOXONE HYDROCHLORIDE .4 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 60842-051_0fc9b456-c6af-408f-b061-c974b1d4d121 60842-051 HUMAN PRESCRIPTION DRUG Evzio naloxone hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20161019 NDA NDA209862 kaleo, Inc. NALOXONE HYDROCHLORIDE 2 mg/.4mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 60846-201_5f0f6cc8-ea49-9364-e053-2991aa0a0999 60846-201 HUMAN PRESCRIPTION DRUG Activella estradiol and norethindrone acetate TABLET, FILM COATED ORAL 20160512 NDA NDA020907 Gemini Laboratories, LLC ESTRADIOL; NORETHINDRONE ACETATE .5; .1 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 60846-202_5f0f6cc8-ea49-9364-e053-2991aa0a0999 60846-202 HUMAN PRESCRIPTION DRUG Activella estradiol and norethindrone acetate TABLET, FILM COATED ORAL 20160512 NDA NDA020907 Gemini Laboratories, LLC ESTRADIOL; NORETHINDRONE ACETATE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 60846-301_3a1abd05-b955-1fdd-e054-00144ff8d46c 60846-301 HUMAN PRESCRIPTION DRUG Nizatidine Solution Nizatidine SOLUTION ORAL 20160812 ANDA ANDA090576 Gemini Laboratories, LLC NIZATIDINE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 60846-501_5645d104-46e1-601a-e054-00144ff88e88 60846-501 HUMAN PRESCRIPTION DRUG Pyridium Phenazopyridine TABLET, FILM COATED ORAL 20110201 UNAPPROVED DRUG OTHER Gemini Laboratories, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 60846-502_5645d104-46e1-601a-e054-00144ff88e88 60846-502 HUMAN PRESCRIPTION DRUG Pyridium Phenazopyridine TABLET, FILM COATED ORAL 20110201 UNAPPROVED DRUG OTHER Gemini Laboratories, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 60846-701_60184dd5-a514-d82d-e053-2a91aa0afaba 60846-701 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20160311 20181130 ANDA ANDA206297 Gemini Laboratories, Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 60846-801_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-801 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60846-802_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-802 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60846-803_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-803 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60846-804_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-804 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60846-805_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-805 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60846-806_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-806 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60846-807_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-807 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60846-808_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-808 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60846-809_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-809 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60846-810_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-810 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60846-811_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-811 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60846-812_1e8f60c9-98ed-4362-a7d0-a28a8950d21b 60846-812 HUMAN PRESCRIPTION DRUG Unithroid levothyroxine sodium TABLET ORAL 20140703 NDA NDA021210 Gemini Laboratories, LLC LEVOTHYROXINE SODIUM 300 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 60846-882_60cb3375-80f4-7dc7-e053-2a91aa0a6ccd 60846-882 HUMAN PRESCRIPTION DRUG Prandin Repaglinide TABLET ORAL 20170202 ANDA ANDA077571 Gemini Laboratories, LLC REPAGLINIDE 1 mg/mg Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 60846-884_60cb3375-80f4-7dc7-e053-2a91aa0a6ccd 60846-884 HUMAN PRESCRIPTION DRUG Prandin Repaglinide TABLET ORAL 20170202 ANDA ANDA077571 Gemini Laboratories, LLC REPAGLINIDE 2 mg/mg Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 60846-901_56321437-8814-44a4-e054-00144ff88e88 60846-901 HUMAN PRESCRIPTION DRUG REPREXAIN Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20131227 20181031 ANDA ANDA076642 Gemini Laboratories, LLC HYDROCODONE BITARTRATE; IBUPROFEN 5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 60846-902_56321437-8814-44a4-e054-00144ff88e88 60846-902 HUMAN PRESCRIPTION DRUG REPREXAIN Hydrocodone Bitartrate and Ibuprofen TABLET, FILM COATED ORAL 20131227 20190131 ANDA ANDA076642 Gemini Laboratories, LLC HYDROCODONE BITARTRATE; IBUPROFEN 10; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 60846-970_60f579a6-ee7c-722b-e053-2991aa0a4a67 60846-970 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 Gemini Laboratories, LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 60846-971_60f579a6-ee7c-722b-e053-2991aa0a4a67 60846-971 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 Gemini Laboratories, LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 60854-001_873b494e-c286-44f5-8d9e-421289376fe7 60854-001 HUMAN OTC DRUG ARNICA DE LA ABUELA HETEROTHECA INULOIDES CASS, WINTERGREEN, BALSAM OF PERU OINTMENT TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 LABORATORIOS BREMER, S.A. HETEROTHECA INULOIDES FLOWER; METHYL SALICYLATE; BALSAM PERU .59; 1.48; .88 g/104mL; g/104mL; g/104mL N 20181231 60854-002_40bd7811-ee8d-4c96-bc98-726201a4cd10 60854-002 HUMAN OTC DRUG AIM Muscle Pain Relief Cream METHYL SALICYLATE, MENTHOL, CAMPHOR CREAM TOPICAL 20180104 OTC MONOGRAPH NOT FINAL part348 LABORATORIOS BREMER, S.A. METHYL SALICYLATE; MENTHOL; CAMPHOR (NATURAL) 10; 1.5; 2.5 g/100g; g/100g; g/100g N 20191231 60858-314_443b29d5-edb3-4213-8109-9cf2b1729111 60858-314 HUMAN OTC DRUG END-ITCH oatmeal CREAM TOPICAL 20140106 OTC MONOGRAPH FINAL part347 Crystal Connections, LLC OATMEAL .0287 g/g E 20171231 60858-315_b757f29d-e7cd-4694-b5f5-5763c68f27a8 60858-315 HUMAN OTC DRUG END-ITCH FOR ECZEMA END-ITCH FOR ECZEMA CREAM TOPICAL 20150515 OTC MONOGRAPH FINAL part347 Crystal Connections, LLC OATMEAL .24 g/mL E 20171231 60858-316_c1ef8771-9a7a-4d3e-9d13-4d1a9ccfe239 60858-316 HUMAN OTC DRUG END-ITCH FOR SUNBURN END-ITCH FOR SUNBURN CREAM TOPICAL 20150515 OTC MONOGRAPH FINAL part347 Crystal Connections, LLC OATMEAL 11.62 g/g E 20171231 60867-100_86913b70-8162-44fb-baee-e92d7c20f16e 60867-100 HUMAN OTC DRUG safeHands Benzalkonium Chloride LIQUID TOPICAL 20140927 OTC MONOGRAPH NOT FINAL part333A safeHands LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 60867-101_c6c02448-eb63-4f65-9200-4673d6bf62b8 60867-101 HUMAN OTC DRUG safeHands Benzalkonium chloride LIQUID TOPICAL 20140927 OTC MONOGRAPH NOT FINAL part333A safeHands LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 60867-102_21249559-395e-4225-ae22-a97888201912 60867-102 HUMAN OTC DRUG safeHands Benzalkonium chloride LIQUID TOPICAL 20140927 OTC MONOGRAPH NOT FINAL part333A safeHands LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 60867-103_4ccce158-4854-4d0d-89da-cb8262275e6e 60867-103 HUMAN OTC DRUG safeHands Squirts Benzalkonium chloride LIQUID TOPICAL 20140927 OTC MONOGRAPH NOT FINAL part333A safeHands LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 60867-104_2bc1fb37-5e5d-46ca-b321-f54c446e9bb6 60867-104 HUMAN OTC DRUG safeHands Squirts Benzalkonium chloride LIQUID TOPICAL 20140927 OTC MONOGRAPH NOT FINAL part333A safeHands LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 60867-105_4d0de7b6-7673-47b8-9a18-d5551bb1f8a1 60867-105 HUMAN OTC DRUG safeHands Squirts Benzalkonium chloride LIQUID TOPICAL 20140927 OTC MONOGRAPH NOT FINAL part333A safeHands LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 60875-100_9bc8f6fc-ecbc-4269-86ae-ce0de8184266 60875-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100524 UNAPPROVED MEDICAL GAS Jim's Pharmacy OXYGEN 992 mL/L E 20171231 60881-555_eb790611-1402-415e-9062-dff11826dbdd 60881-555 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19880101 UNAPPROVED MEDICAL GAS Allen Medical, Inc OXYGEN 99 L/100L E 20171231 60892-601_f290a608-92ee-49e0-957e-b67f1006f489 60892-601 HUMAN OTC DRUG TriLipiderm Broad Spectrum SPF 30 Butyl Methoxydibenzoylmethane, Ethylhexyl methoxycinnamate, Homosalate, Octocrylene CREAM TOPICAL 20140131 OTC MONOGRAPH FINAL part352 TriLipid Research Institute, LLC AVOBENZONE; OCTINOXATE; HOMOSALATE; OCTOCRYLENE 3; 7.5; 10; 2.7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 60899-010_7262e2eb-e7de-452c-81d3-f6f64603465a 60899-010 HUMAN OTC DRUG Seaweed Aqua Massage Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN 1.5 g/300g N 20181231 60899-020_2bf5bb8b-96b2-4057-bf16-3ed7b8473519 60899-020 HUMAN OTC DRUG Nano Gold Bio Mask Pack Allantoin PATCH TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .17 mg/35mL N 20181231 60899-030_4b22428c-d4f4-4948-8cbd-1a33e24ac4d5 60899-030 HUMAN OTC DRUG Camellia Multiaction UV Sun Serum Titanium Dioxide, OCTINOXATE CREAM TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 AMAROS CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 1.88; 1.4 mg/40mL; mg/40mL N 20181231 60899-040_2c4505e8-c145-480c-a1a6-c780261a3a53 60899-040 HUMAN OTC DRUG OHL O2 Allantoin SPRAY TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .3 mg/60mL N 20181231 60899-050_c9794724-eccb-43bf-967a-ce7477d13e25 60899-050 HUMAN OTC DRUG Seaweed Cleansing Mineral Oil LIQUID TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. MINERAL OIL 75 mg/150mL N 20181231 60899-060_b15871aa-0139-4f2c-a9b8-a836099f988a 60899-060 HUMAN OTC DRUG Herbal Skin Toner Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .75 mg/150mL N 20181231 60899-070_63ff976c-af90-4ce7-9375-c17104b807a3 60899-070 HUMAN OTC DRUG NoblRose Foam Cleanser Allantoin LIQUID TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .75 mg/150mL N 20181231 60899-080_0cd2cb88-fc95-4881-abc4-d61cfe77bfbc 60899-080 HUMAN OTC DRUG Acne Lab Foam Cleanser Salicylic acid LIQUID TOPICAL 20130901 OTC MONOGRAPH FINAL part333D AMAROS CO., LTD. SALICYLIC ACID .75 mg/150mL N 20181231 60899-090_ce6e208a-ccc1-45bb-ba32-c5ea97da4486 60899-090 HUMAN OTC DRUG Vital Fluid IV Nano Gold Serum Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .15 mg/30mL N 20181231 60899-100_e950e196-d09e-4ad0-8a1e-9d05f23f7037 60899-100 HUMAN OTC DRUG Vital Fluid II EGF and FGF Whitening Serum Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .15 mg/30mL N 20181231 60899-110_268b1884-aef4-48cd-8c3e-0f8f2f2baafe 60899-110 HUMAN OTC DRUG Vital Fluid I Platinum Anti Wrinkle Serum Allantoin CREAM TOPICAL 20130901 OTC MONOGRAPH FINAL part347 AMAROS CO., LTD. ALLANTOIN .15 mg/30mL N 20181231 60900-555_1fc33789-c0fc-4aa9-b865-2690af27f544 60900-555 HUMAN OTC DRUG Re-Gro minoxidil SOLUTION TOPICAL 20140401 ANDA ANDA074588 Empress Hair Products, Ltd. MINOXIDIL 2 g/100mL N 20181231 60905-0001_61913cca-8fe3-2f7c-e053-2991aa0ab824 60905-0001 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Ivory Tint 1 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE; OCTINOXATE 31.6; 29.97 mg/mL; mg/mL N 20181231 60905-0002_61913cca-8ff1-2f7c-e053-2991aa0ab824 60905-0002 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Petal Tint 2 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120706 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE; OCTINOXATE 31.6; 29.97 mg/mL; mg/mL N 20181231 60905-0004_61913cca-8ffd-2f7c-e053-2991aa0ab824 60905-0004 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Vanilla Tint 4 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE; OCTINOXATE 31.6; 29.97 mg/mL; mg/mL N 20181231 60905-0005_61914479-2b58-6f71-e053-2a91aa0a0385 60905-0005 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Praline Tint 5 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE; OCTINOXATE 31.6; 29.97 mg/mL; mg/mL N 20181231 60905-0006_318dd24c-c12f-2ecd-e054-00144ff88e88 60905-0006 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Honey Tint 6 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE; OCTINOXATE 31.6; 29.97 mg/mL; mg/mL N 20181231 60905-0007_318e2416-31eb-3baa-e054-00144ff88e88 60905-0007 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Gold Tint 7 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE; OCTINOXATE 31.6; 29.97 mg/mL; mg/mL N 20181231 60905-0008_bf81d284-fad9-4598-b070-26bae4b948c5 60905-0008 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Amber Tint 8 TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20120708 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE; OCTINOXATE 3.16; 2.997 mL/100mL; mL/100mL N 20181231 60905-0010_6191106d-2f83-26c0-e053-2a91aa0a5e78 60905-0010 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation Broad Spectrum SPF 20 Perfect Beige TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20121220 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE; OCTINOXATE 31.6; 29.97 mg/mL; mg/mL N 20181231 60905-0011_6191630b-6034-78f4-e053-2991aa0a9c37 60905-0011 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation Broad Spectrum SPF 20 Perfect Cinnamon TITANIUM DIOXIDE, OCTINOXATE LIQUID TOPICAL 20121220 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE; OCTINOXATE 31.6; 29.97 mg/mL; mg/mL N 20181231 60905-0020_6191630b-6045-78f4-e053-2991aa0a9c37 60905-0020 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT PORCELAIN TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL N 20181231 60905-0021_61914479-2b69-6f71-e053-2a91aa0a0385 60905-0021 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT SHELL TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL N 20181231 60905-0022_6191630b-6056-78f4-e053-2991aa0a9c37 60905-0022 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT SAND TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL N 20181231 60905-0023_6191630b-6067-78f4-e053-2991aa0a9c37 60905-0023 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT BEIGE TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL N 20181231 60905-0024_61918b73-75d3-e953-e053-2a91aa0aaa83 60905-0024 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT HONEY TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL N 20181231 60905-0025_61912762-9f46-506e-e053-2a91aa0af33f 60905-0025 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT GOLD TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL N 20181231 60905-0026_61912762-9f57-506e-e053-2a91aa0af33f 60905-0026 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT GINGER TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL N 20181231 60905-0027_61918b73-75e5-e953-e053-2a91aa0aaa83 60905-0027 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT AMBER TITANIUM DIOXIDE LIQUID TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL N 20181231 60905-0028_61919df7-c068-0cb9-e053-2a91aa0a5e1d 60905-0028 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT BROWN TITANIUM DIOXIDE LIQUID TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL N 20181231 60905-0029_61918b73-75f6-e953-e053-2a91aa0aaa83 60905-0029 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT SIENNA TITANIUM DIOXIDE LIQUID TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL N 20181231 60905-0030_61919df7-c08c-0cb9-e053-2a91aa0a5e1d 60905-0030 HUMAN OTC DRUG Givenchy TEINT COUTURE Long Wearing Fluid Foundation with Sunscreen Broad Spectrum SPF 20 ELEGANT VANILLA TITANIUM DIOXIDE LIQUID TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 29.2 mg/mL N 20181231 60905-0040_3230afaf-89e9-723a-e054-00144ff8d46c 60905-0040 HUMAN OTC DRUG Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum SPF 15 Nude Porcelain OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 39.96; 21.9 mg/mL; mg/mL N 20181231 60905-0041_3230afaf-89d5-723a-e054-00144ff8d46c 60905-0041 HUMAN OTC DRUG Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum SPF 15 Nude Shell OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 39.96; 21.9 mg/mL; mg/mL N 20181231 60905-0042_32308a79-be5c-62ae-e054-00144ff88e88 60905-0042 HUMAN OTC DRUG Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum SPF 15 Nude Sand OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 39.96; 21.9 mg/mL; mg/mL N 20181231 60905-0043_3230912d-f150-6c9f-e054-00144ff8d46c 60905-0043 HUMAN OTC DRUG Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum SPF 15 Nude Beige OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 39.96; 21.9 mg/mL; mg/mL N 20181231 60905-0044_32308a79-be4c-62ae-e054-00144ff88e88 60905-0044 HUMAN OTC DRUG Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum SPF 15 Nude Honey OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 39.96; 21.9 mg/mL; mg/mL N 20181231 60905-0045_32307aff-40ab-686c-e054-00144ff8d46c 60905-0045 HUMAN OTC DRUG Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum SPF 15 Nude Gold OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 39.96; 21.9 mg/mL; mg/mL N 20181231 60905-0046_322fc92e-8c8c-2004-e054-00144ff8d46c 60905-0046 HUMAN OTC DRUG Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum SPF 15 Nude Ginger OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 39.96; 21.9 mg/mL; mg/mL N 20181231 60905-0047_3230afaf-89fc-723a-e054-00144ff8d46c 60905-0047 HUMAN OTC DRUG Givenchy Blurring Foundation Balm Bare Skin Perfector - Broad Spectrum SPF 15 Nude Amber OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 39.96; 21.9 mg/mL; mg/mL N 20181231 60905-0048_6191aa37-9158-207c-e053-2a91aa0af2d0 60905-0048 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Cashew Tint 5.5 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150724 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 29.97; 31.6 mg/mL; mg/mL N 20181231 60905-0049_6191bced-5725-fc7d-e053-2991aa0ad4b3 60905-0049 HUMAN OTC DRUG Givenchy Photo Perfexion Fluid Foundation SPF 20 Perfect Suede Tint 6.5 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150724 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 29.97; 31.6 mg/mL; mg/mL N 20181231 60905-0050_6191c39d-70b3-50e8-e053-2a91aa0a6108 60905-0050 HUMAN OTC DRUG Givenchy PHOTO PERFEXION - Fluid Foundation with sunscreen Broad Spectrum SPF 20 Shade 105 Perfect Ginger OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 29.97; 31.6 mg/mL; mg/mL N 20181231 60905-0051_6191bced-5733-fc7d-e053-2991aa0ad4b3 60905-0051 HUMAN OTC DRUG Givenchy PHOTO PERFEXION - Fluid Foundation with sunscreen Broad Spectrum SPF 20 Shade 106 Perfect Pecan OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 29.97; 31.6 mg/mL; mg/mL N 20181231 60905-0052_6191c39d-70c1-50e8-e053-2a91aa0a6108 60905-0052 HUMAN OTC DRUG Givenchy PHOTO PERFEXION Fluid Foundation with sunscreen Broad Spectrum SPF 20 Shade 130 Perfect Rose OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20151212 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 29.97; 31.6 mg/mL; mg/mL N 20181231 60905-0062_643b8738-2fb1-27ed-e053-2a91aa0a06bd 60905-0062 HUMAN OTC DRUG PRISME PRIMER Color Correcting Primer SPF 20 PA Shade 02 ROSE Octinoxate, Titanium Dioxide CREAM TOPICAL 20180201 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 40; 23.7 mg/mL; mg/mL N 20191231 60905-0063_643b8738-2fc1-27ed-e053-2a91aa0a06bd 60905-0063 HUMAN OTC DRUG PRISME PRIMER Color Correcting Primer SPF 20 PA Shade 03 JAUNE Octinoxate, Titanium Dioxide CREAM TOPICAL 20180201 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 40; 23.7 mg/mL; mg/mL N 20191231 60905-0064_643b8738-2fd4-27ed-e053-2a91aa0a06bd 60905-0064 HUMAN OTC DRUG PRISME PRIMER Color Correcting Primer SPF 20 PA Shade 04 ABRICOT Octinoxate, Titanium Dioxide CREAM TOPICAL 20180201 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 40; 23.7 mg/mL; mg/mL N 20191231 60905-0065_643b81f8-5d3a-7c4f-e053-2991aa0a16c9 60905-0065 HUMAN OTC DRUG PRISME PRIMER Color Correcting Primer SPF 20 PA Shade 05 VERT Octinoxate, Titanium Dioxide CREAM TOPICAL 20180201 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands OCTINOXATE; TITANIUM DIOXIDE 40; 23.7 mg/mL; mg/mL N 20191231 60905-0401_7af25a9e-01bd-4f68-8315-b470101221f7 60905-0401 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 1 TITANIUM DIOXIDE CREAM TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0402_14781e5c-8af6-4fef-8525-1d61b01404b5 60905-0402 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 2 TITANIUM DIOXIDE CREAM TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0403_b065bef0-7e27-40b4-8628-a00df8cbdfdf 60905-0403 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 3 TITANIUM DIOXIDE CREAM TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0404_f4622835-e65c-4cf1-bd72-a90cb7e38d7e 60905-0404 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 4 TITANIUM DIOXIDE CREAM TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0405_fbc3d958-a309-4c42-8886-51e99c60adfb 60905-0405 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 5 TITANIUM DIOXIDE CREAM TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0406_de2d2db4-9123-4e2e-8590-03003e193b70 60905-0406 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 6 TITANIUM DIOXIDE CREAM TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0407_8d9cb989-c10f-4d3a-b014-e541dd95ae2c 60905-0407 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 7 TITANIUM DIOXIDE CREAM TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0408_07483314-66c2-446d-89ae-09a2666faa0d 60905-0408 HUMAN OTC DRUG Givenchy Fluid Foundation Airy-light Mat Radiance SPF 20 Tint 8 TITANIUM DIOXIDE CREAM TOPICAL 20110623 OTC MONOGRAPH FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0600_6191aa37-9172-207c-e053-2a91aa0af2d0 60905-0600 HUMAN OTC DRUG MATISSIME VELVET Radiant Mat Fluid Foundation with Sunscreen Broad Spectrum SPF 20 Mat Porcelain 01 TITANIUM DIOXIDE CREAM TOPICAL 20161202 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0601_6191aa37-918e-207c-e053-2a91aa0af2d0 60905-0601 HUMAN OTC DRUG MATISSIME VELVET Radiant Mat Fluid Foundation with Sunscreen Broad Spectrum SPF 20 Mat Shell 02 TITANIUM DIOXIDE CREAM TOPICAL 20161202 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0602_619171d6-18cf-3e00-e053-2991aa0a4ba6 60905-0602 HUMAN OTC DRUG MATISSIME VELVET Radiant Mat Fluid Foundation with Sunscreen Broad Spectrum SPF 20 Mat Sand 03 TITANIUM DIOXIDE CREAM TOPICAL 20161202 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0603_61922151-d995-577a-e053-2a91aa0ac777 60905-0603 HUMAN OTC DRUG MATISSIME VELVET Radiant Mat Fluid Foundation with Sunscreen Broad Spectrum SPF 20 Mat Beige 04 TITANIUM DIOXIDE CREAM TOPICAL 20161202 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0604_61922977-4bd0-680b-e053-2a91aa0afcc7 60905-0604 HUMAN OTC DRUG MATISSIME VELVET Radiant Mat Fluid Foundation with Sunscreen Broad Spectrum SPF 20 Mat Honey 05 TITANIUM DIOXIDE CREAM TOPICAL 20161202 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0605_61922151-d9c6-577a-e053-2a91aa0ac777 60905-0605 HUMAN OTC DRUG MATISSIME VELVET Radiant Mat Fluid Foundation with Sunscreen Broad Spectrum SPF 20 Mat Gold 06 TITANIUM DIOXIDE CREAM TOPICAL 20161202 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0606_6191d2ea-654c-e9f0-e053-2991aa0a5fa1 60905-0606 HUMAN OTC DRUG MATISSIME VELVET Radiant Mat Fluid Foundation with Sunscreen Broad Spectrum SPF 20 Mat Ginger 07 TITANIUM DIOXIDE CREAM TOPICAL 20161202 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60905-0607_6191d2ea-655b-e9f0-e053-2991aa0a5fa1 60905-0607 HUMAN OTC DRUG MATISSIME VELVET Radiant Mat Fluid Foundation with Sunscreen Broad Spectrum SPF 20 Mat Amber 08 TITANIUM DIOXIDE CREAM TOPICAL 20161202 OTC MONOGRAPH NOT FINAL part352 LVMH Fragrance Brands TITANIUM DIOXIDE 31.6 mg/mL N 20181231 60913-006_6e865bc2-7510-4e75-a6f3-76625d659aaf 60913-006 HUMAN OTC DRUG Alcohol Prep Pads Isopropyl Alcohol SWAB TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 60913-007_1b195819-bb65-4c43-b468-a9e65c10fd76 60913-007 HUMAN OTC DRUG Alcohol Prep Pads Isopropyl Alcohol SWAB TOPICAL 20141006 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 60913-008_17f95b26-5109-433d-876a-28d63d570752 60913-008 HUMAN OTC DRUG Alcohol Prep Pads Isopropyl Alcohol SWAB TOPICAL 20141105 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 60913-009_12ae05be-f44c-4b73-9e35-d3528b2cfa70 60913-009 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20150219 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 60913-010_96ed3940-cdc6-4d40-bb77-5bfe2e5de505 60913-010 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20150226 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 60913-017_fa97aa8a-455f-4779-9b61-0e17a992e013 60913-017 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20150226 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 60913-018_f2438b06-2845-40b2-b533-7b733bef2c19 60913-018 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20150226 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 60913-031_d4eeb94b-e480-4dcf-b28b-3d6b1fa5ac99 60913-031 HUMAN OTC DRUG Sting and Bite Benzocaine SWAB TOPICAL 20150223 OTC MONOGRAPH NOT FINAL part348 PHOENIX HEALTHCARE SOLUTIONS, LLC BENZOCAINE 6 g/100mL N 20181231 60913-041_a6f0df58-c36c-48c5-8fbc-d2c31ba8c2a2 60913-041 HUMAN OTC DRUG Alcohol Swab Sticks Isopropyl Alcohol SWAB TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 60913-051_8ff68ad6-01c0-426b-999c-99a383cdda68 60913-051 HUMAN OTC DRUG Povidone Iodine Prep Swabstick Povidone Iodine SOLUTION TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC POVIDONE-IODINE 1 g/100mL N 20181231 60913-060_20960b09-6d32-4b33-a291-725c115d8c6a 60913-060 HUMAN OTC DRUG BZK Antiseptic Towelette Benzalkonium Chloride SOLUTION TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC BENZALKONIUM CHLORIDE .13 g/100g N 20181231 60913-061_6220b927-7681-419d-a0e6-ff30607f9c07 60913-061 HUMAN OTC DRUG Lemon Glycerine Swabsticks Glycerine SWAB TOPICAL 20150714 OTC MONOGRAPH NOT FINAL part356 PHOENIX HEALTHCARE SOLUTIONS, LLC GLYCERIN 7.5 g/100g N 20181231 60913-999_bb1493fe-8fa6-48f4-b2fd-7329af815807 60913-999 HUMAN OTC DRUG Povidone Iodine Prep Povidone Iodine SWAB TOPICAL 20150226 OTC MONOGRAPH NOT FINAL part333A PHOENIX HEALTHCARE SOLUTIONS, LLC POVIDONE-IODINE 1 g/100mL N 20181231 60914-001_03e4f66f-da1c-1d6f-e054-00144ff8d46c 60914-001 HUMAN OTC DRUG Soothing First Aid Cream Soothing First Aid Cream CREAM TOPICAL 20140922 UNAPPROVED HOMEOPATHIC Homeo Health, Inc. ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; LYTTA VESICATORIA; CAUSTICUM; HYPERICUM PERFORATUM; DELPHINIUM STAPHISAGRIA SEED 4; 1; 5; 6; 1; 5 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 60916-001_4d28d68d-0793-4f45-9dbf-ce38cede000c 60916-001 HUMAN OTC DRUG Migranade Chamomilla, Natrum Sulphuricum, Sanguinaria Canadensis, Glutathione SPRAY NASAL 20140127 UNAPPROVED HOMEOPATHIC Migranade Inc. CHAMOMILE; SODIUM SULFATE; SANGUINARIA CANADENSIS ROOT; GLUTATHIONE 3; 3; 3; 1 [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL E 20171231 60916-002_35f22641-b925-480b-9dd3-b1c91181648c 60916-002 HUMAN OTC DRUG Migranade Chamomilla, Natrum Sulphuricum, Sanguinaria Canadensis, Glutathione TABLET ORAL 20140801 UNAPPROVED HOMEOPATHIC Migranade Inc. CHAMOMILE; SODIUM SULFATE; SANGUINARIA CANADENSIS ROOT; GLUTATHIONE 3; 3; 3; 1 [hp_C]/3g; [hp_C]/3g; [hp_C]/3g; [hp_C]/3g E 20171231 60919-1073_c0918fae-0583-446e-bcbd-29946a71378f 60919-1073 HUMAN PRESCRIPTION DRUG Liquid Oxygen Liquid Oxygen GAS RESPIRATORY (INHALATION) 20131205 UNAPPROVED MEDICAL GAS Hospice Express, Inc. OXYGEN 995 mL/L E 20171231 60923-284_8b949524-3ea3-4703-a31e-8336d5051eef 60923-284 HUMAN PRESCRIPTION DRUG Exondys 51 eteplirsen INJECTION INTRAVENOUS 20160919 NDA NDA206488 Sarepta Therapeutics, Inc. ETEPLIRSEN 50 mg/mL Antisense Oligonucleotide [EPC],Oligonucleotides, Antisense [Chemical/Ingredient] N 20181231 60923-363_8b949524-3ea3-4703-a31e-8336d5051eef 60923-363 HUMAN PRESCRIPTION DRUG Exondys 51 eteplirsen INJECTION INTRAVENOUS 20160919 NDA NDA206488 Sarepta Therapeutics, Inc. ETEPLIRSEN 50 mg/mL Antisense Oligonucleotide [EPC],Oligonucleotides, Antisense [Chemical/Ingredient] N 20181231 60927-115_de02462d-3131-4934-801e-c120688b06f3 60927-115 HUMAN OTC DRUG Smarth Extra Strength Baking Soda Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20131201 OTC MONOGRAPH FINAL part355 Carib Sales, LLC SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 60927-116_8cd7c69c-0b93-4bd4-9643-ec63c386d89f 60927-116 HUMAN OTC DRUG Smarth Extra Strength Minty Fresh Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20131201 OTC MONOGRAPH FINAL part355 Carib Sales, LLC SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 60927-117_a523849e-cf74-4e0d-b055-918e23dc5f91 60927-117 HUMAN OTC DRUG SMARTH Extra Strength REGULAR SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131201 OTC MONOGRAPH FINAL part355 Carib Sales, LLC SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 60927-118_055490e3-e4be-45d5-a1cf-c30a06ba8c42 60927-118 HUMAN OTC DRUG Smarth Extra Strength Whitening Sodium monofluorophosphate PASTE, DENTIFRICE DENTAL 20131201 OTC MONOGRAPH FINAL part355 Carib Sales, LLC SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 60933-200_61f32a87-f7d1-1354-e053-2991aa0a8d98 60933-200 HUMAN OTC DRUG Alcohol Free Hand Sanitizer BENZALKONIUM CHLORIDE AEROSOL, FOAM TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part333E Fuller Industries, LLC BENZALKONIUM CHLORIDE 1 mg/mL N 20191231 60934-002_601820b2-1cee-988f-e053-2a91aa0ae9bd 60934-002 HUMAN OTC DRUG Spot Correction SULFUR CREAM TOPICAL 20170111 OTC MONOGRAPH FINAL part333D HydroPeptide LLC SULFUR 30 mg/mL N 20181231 60934-003_60183a47-fcf1-052b-e053-2991aa0a1b5c 60934-003 HUMAN OTC DRUG Solar Defense Non Tinted TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170111 OTC MONOGRAPH NOT FINAL part352 HydroPeptide LLC TITANIUM DIOXIDE; ZINC OXIDE 30; 70 mg/mL; mg/mL N 20181231 60934-004_601841d7-b20a-70c6-e053-2a91aa0a41c6 60934-004 HUMAN OTC DRUG Solar Defense Body AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AEROSOL, SPRAY TOPICAL 20170112 OTC MONOGRAPH NOT FINAL part352 HydroPeptide LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 60934-005_60183003-457b-9f32-e053-2a91aa0aba08 60934-005 HUMAN OTC DRUG Solar Defense Tinted TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170111 OTC MONOGRAPH NOT FINAL part352 HydroPeptide LLC TITANIUM DIOXIDE; ZINC OXIDE 25; 60 mg/mL; mg/mL N 20181231 60939-101_79831130-ef96-4414-8cb5-a1545e304948 60939-101 HUMAN OTC DRUG WHY Diaper Rash Pads Zinc Oxide CLOTH TOPICAL 20150121 OTC MONOGRAPH FINAL part347 WELLNESS AND HEALTH FOR YOU LLC ZINC OXIDE 20 g/100g E 20171231 60949-010_0b59bb23-7535-402c-a5c2-f6d47158dc74 60949-010 HUMAN OTC DRUG By Pharmicell Lab The Prestige GLYCERIN CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. GLYCERIN 10 g/50g E 20171231 60949-020_87154bb0-de2b-4d33-8ad7-532b5963294d 60949-020 HUMAN OTC DRUG By Pharmicell Lab The Prestige Essence ALLANTOIN CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .22 mg/45mL E 20171231 60949-030_3b9ed51d-50fe-4335-89a7-d4b999be1048 60949-030 HUMAN OTC DRUG By Pharmicell Lab Prestige Sun Block SPF40 PA PLUS PLUS PLUS OCTINOXATE, OCTISALATE, ENSULIZOLE, AVOBENZONE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Pharmicell Co., Ltd. OCTINOXATE; OCTISALATE; ENSULIZOLE; AVOBENZONE 2.75; 2.5; 2; 1.5 g/50g; g/50g; g/50g; g/50g E 20171231 60949-040_1b6cb178-e94e-4b6c-b497-dc8c9f5ddbf6 60949-040 HUMAN OTC DRUG By Pharmicell Lab Prestige BB SPF30 PA PLUS PLUS TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Pharmicell Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5.22; .72 g/50g; g/50g E 20171231 60949-050_8b3e5f45-ff20-4884-a829-ca03f1332034 60949-050 HUMAN OTC DRUG By Pharmicell Lab Luxury Cell Performance DIMETHICONE CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. DIMETHICONE .5 g/50g E 20171231 60949-060_a51869fd-48b9-405a-ba25-f1328ca35372 60949-060 HUMAN OTC DRUG By Pharmicell Lab Luxury Cell Performance Emulsion ALLANTOIN CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .65 mg/130mL E 20171231 60949-070_46e267a3-dfd3-441b-be8b-4c9ffc2b9324 60949-070 HUMAN OTC DRUG By Pharmicell Lab Luxury Cell Performance Eye DIMETHICONE CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. DIMETHICONE .6 g/20g E 20171231 60949-080_755a3314-b4aa-4619-bc40-698a466e5dda 60949-080 HUMAN OTC DRUG By Pharmicell Lab Luxury Cell Performance Serum ALLANTOIN CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .225 mg/45mL E 20171231 60949-090_f09e4bf2-1147-4c1d-8e3d-06dee3541ee7 60949-090 HUMAN OTC DRUG By Pharmicell Lab Luxury Cell Performance Toner ALLANTOIN CREAM TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .65 mg/130mL E 20171231 60949-100_1c8c2dfa-376c-4a14-b4ef-6744402a7033 60949-100 HUMAN OTC DRUG By Pharmicell Lab Moisturizing Face Toning Mist ALLANTOIN SPRAY TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .6 mg/120mL E 20171231 60949-110_b98f36fc-f9da-4699-b2cc-88c7dc1076cc 60949-110 HUMAN OTC DRUG By Pharmicell Lab Beaucell Dual Hydrogel Mask GLYCERIN PATCH TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. GLYCERIN 9 g/51 E 20171231 60949-120_bb45083d-2605-4cdf-b25a-feba2456d2dd 60949-120 HUMAN OTC DRUG Luxury Cell Performance Toner ALLANTOIN CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .65 mg/130mL E 20171231 60949-130_74318e49-75c9-4d0a-a2d3-bce48ca030fb 60949-130 HUMAN OTC DRUG Luxury Cell Performance Emulsion ALLANTOIN CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .65 mg/130mL E 20171231 60949-140_1e7d20a0-cc90-47d2-9926-82cbbee8bf7c 60949-140 HUMAN OTC DRUG Luxury Cell Performance Serum ALLANTOIN CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .22 mg/45mL E 20171231 60949-150_f912f2ce-3a52-4da2-a176-7be588c117af 60949-150 HUMAN OTC DRUG Luxury Cell Performance Eye DIMETHICONE CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. DIMETHICONE .6 g/20g E 20171231 60949-160_cd227d1c-f94e-4ba0-ab36-ed2dd23f8881 60949-160 HUMAN OTC DRUG Luxury Cell Performance DIMETHICONE CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. DIMETHICONE .5 g/50g E 20171231 60949-170_64c38752-06e5-400c-a95d-272fcae7df5e 60949-170 HUMAN OTC DRUG The Prestige Essence ALLANTOIN CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. ALLANTOIN .22 mg/45mL E 20171231 60949-180_7b1ea48d-d4f3-4116-95a3-8502305d8c85 60949-180 HUMAN OTC DRUG The Prestige GLYCERIN CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Pharmicell Co., Ltd. GLYCERIN 10 g/50g E 20171231 60951-602_1d3b220a-7df7-4545-86b4-828bc6184f64 60951-602 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20000526 ANDA ANDA040330 Par Pharmaceutical OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60951-652_6508e9eb-37fe-4135-811c-abbb77c9f086 60951-652 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 19981031 ANDA ANDA075295 Qualitest Pharmaceuticals MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60951-653_6508e9eb-37fe-4135-811c-abbb77c9f086 60951-653 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 19981031 ANDA ANDA075295 Qualitest Pharmaceuticals MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60951-655_6508e9eb-37fe-4135-811c-abbb77c9f086 60951-655 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 19981031 ANDA ANDA075295 Qualitest Pharmaceuticals MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60951-658_6508e9eb-37fe-4135-811c-abbb77c9f086 60951-658 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 19981031 ANDA ANDA075295 Qualitest Pharmaceuticals MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60951-659_6508e9eb-37fe-4135-811c-abbb77c9f086 60951-659 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 19981031 ANDA ANDA075295 Qualitest Pharmaceuticals MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60951-700_1d3b220a-7df7-4545-86b4-828bc6184f64 60951-700 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20030306 ANDA ANDA040434 Par Pharmaceutical OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60951-701_1d3b220a-7df7-4545-86b4-828bc6184f64 60951-701 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20030306 ANDA ANDA040330 Par Pharmaceutical OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60951-712_1d3b220a-7df7-4545-86b4-828bc6184f64 60951-712 HUMAN PRESCRIPTION DRUG ENDOCET Oxycodone and Acetaminophen TABLET ORAL 20030306 ANDA ANDA040434 Par Pharmaceutical OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60951-794_59aa8319-de00-4282-98ff-98c41ee36748 60951-794 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20100929 NDA AUTHORIZED GENERIC NDA021611 Par Pharmaceutical OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60951-795_59aa8319-de00-4282-98ff-98c41ee36748 60951-795 HUMAN PRESCRIPTION DRUG Oxymorphone Hydrochloride Oxymorphone Hydrochloride TABLET ORAL 20100929 NDA AUTHORIZED GENERIC NDA021611 Par Pharmaceutical OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 60971-1176_8b714f60-a1bc-4a9b-b2f6-37d705734894 60971-1176 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19931221 UNAPPROVED MEDICAL GAS Lehigh Valley Respiratory Care, Lancaster OXYGEN 99 L/100L E 20171231 60977-141_73031e40-8152-4fc7-ba19-deb93b617d10 60977-141 HUMAN PRESCRIPTION DRUG Protopam Chloride pralidoxime chloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19650310 NDA NDA014134 Baxter Healthcare Corporation PRALIDOXIME CHLORIDE 1 g/20mL Cholinesterase Reactivator [EPC],Cholinesterase Reactivators [MoA] N 20191231 60977-319_07eb92e1-3c44-4567-bbec-a24ed0b39c8a 60977-319 HUMAN PRESCRIPTION DRUG HYLENEX Recombinant Hyaluronidase Recombinant Human INJECTION, SOLUTION SUBCUTANEOUS 20051202 NDA NDA021859 Baxter Healthcare Corporation HYALURONIDASE RECOMBINANT HUMAN 150 [USP'U]/mL Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] E 20171231 60980-001_60dfa804-7306-0df1-e053-2a91aa0a5d9b 60980-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030101 NDA NDA205865 Indian River Oxygen, Inc. OXYGEN 99.8 L/L N 20181231 60986-1003_1391be71-c5d5-474f-bd45-76a575558de9 60986-1003 HUMAN OTC DRUG Allernest Formicum acidum, Lachesis mutus, luffa Operculata. Petroleum, Rhus Toxicodebdron, Aralai racemosa,Galphimia glauca, thuja occidentalis, Urtica dicica and Cardiospermum LIQUID ORAL 20111118 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. FORMIC ACID; LACHESIS MUTA VENOM; LUFFA OPERCULATA FRUIT; KEROSENE; TOXICODENDRON PUBESCENS LEAF; ARALIA RACEMOSA ROOT; GALPHIMIA GLAUCA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; URTICA DIOICA; CARDIOSPERMUM HALICACABUM FLOWERING TOP 12; 8; 6; 6; 6; 4; 4; 4; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 60986-1004_c92dc0a9-c2a0-49ca-aff3-c0b381412ced 60986-1004 HUMAN OTC DRUG Lymphonest Echinacea augustifolia, Scrophularia nodosa, Abrotanum, Petroleum, Aloe socotrina, Mercurius solubilis, Crotalus horiidus, Thuja occidentalis, Lachesis mutus, Aristolochia clematitis LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; ARTEMISIA ABROTANUM FLOWERING TOP; KEROSENE; ALOE; MERCURIUS SOLUBILIS; CROTALUS HORRIDUS HORRIDUS VENOM; THUJA OCCIDENTALIS LEAFY TWIG; LACHESIS MUTA VENOM; ARISTOLOCHIA CLEMATITIS ROOT 1; 1; 3; 3; 1; 12; 10; 10; 8; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 60986-1008_9892a6c9-1ecf-475a-8bf4-11a13532d3c4 60986-1008 HUMAN OTC DRUG Cholenest Rhamnus purshiana, Carduus marianus, Taraxacum officinale, Chelidonium majus, Leptandra virginica, Myrica cerifera, Berberis vulgaris, Natrum sulphuricum, Magnesia phosphorica, Cuprum metallicum LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. FRANGULA PURSHIANA BARK; SILYBUM MARIANUM SEED; TARAXACUM OFFICINALE; CHELIDONIUM MAJUS; VERONICASTRUM VIRGINICUM ROOT; MORELLA CERIFERA ROOT BARK; BERBERIS VULGARIS ROOT BARK; SODIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; COPPER 1; 1; 1; 1; 2; 2; 2; 6; 8; 8 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 60986-1009_10a9a30e-71d4-4957-b285-122ca9ffadaf 60986-1009 HUMAN OTC DRUG Sabal Serrulatum Sabal serulatum, Lycopodium clavatum, Pareira brava LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. SAW PALMETTO; LYCOPODIUM CLAVATUM SPORE; CHONDRODENDRON TOMENTOSUM ROOT 1; 4; 4 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 60986-1011_8bb74f2e-11d3-4428-89c2-be3df15bbbf5 60986-1011 HUMAN OTC DRUG Rubus Rubus Fruticosus, Iris Germanica, Vaccinium Myrtillus, Syzygium Jambolanum, Okoubaka Aubrevillei LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. BLACKBERRY; IRIS GERMANICA ROOT; BILBERRY; SYZYGIUM CUMINI SEED; OKOUBAKA AUBREVILLEI BARK 2; 4; 3; 3; 6 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 60986-1013_4c6f3fc8-9723-42a3-8fc2-9ea160f5a50d 60986-1013 HUMAN OTC DRUG Hydrastis Hydrastis Canadensis, Lycopodium Clavatum, Ephedra Vulgaris, Mezereum, Petroleum, Pulsatilla, Thuja Occidentalis, SPRAY NASAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; EPHEDRA DISTACHYA FLOWERING TWIG; DAPHNE MEZEREUM BARK; KEROSENE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG 4; 3; 3; 3; 8; 3; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 60986-1014_b991bcb6-1827-4f13-a954-2063d3bb3333 60986-1014 HUMAN OTC DRUG Contessa Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Ambra Grisea, Cimi LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ALCHEMILLA XANTHOCHLORA FLOWERING TOP; GALIUM ODORATUM; MATRICARIA RECUTITA; VIOLA ODORATA; CINCHONA OFFICINALIS BARK; MENTHA PIPERITA; ROSMARINUS OFFICINALIS FLOWERING TOP; VALERIAN; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; AMBERGRIS; BLACK COHOSH; CONVALLARIA MAJALIS; SAFFRON; CYCLAMEN PURPURASCENS TUBER; TURNERA DIFFUSA LEAFY TWIG; GOLDENSEAL; CAULOPHYLLUM THALICTROIDES ROOT; LILIUM LANCIFOLIUM FLOWERING TOP; PACKERA AUREA; DELPHINIUM STAPHISAGRIA SEED; NAJA NAJA VENOM 1; 1; 1; 1; 2; 1; 1; 1; 2; 3; 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 8 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 60986-1016_1a3c2fa2-b354-40f2-b01e-d47c285717c9 60986-1016 HUMAN OTC DRUG Trillium Calendula Officinalis, Chamomilla, Crocus Sativus, Equisetum Arvense, Hamamelis Virginiana, Lamium Album, Millefolium, Plantago Major, Quercus Robur, Thlaspi Bursa-Pastoris, Trillium Pendulum, Urtica LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; SAFFRON; EQUISETUM ARVENSE TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LAMIUM ALBUM; ACHILLEA MILLEFOLIUM; PLANTAGO MAJOR; QUERCUS ROBUR FLOWER; CAPSELLA BURSA-PASTORIS; TRILLIUM ERECTUM WHOLE; URTICA DIOICA; VISCUM ALBUM WHOLE 1; 1; 3; 1; 1; 1; 1; 1; 1; 1; 2; 1; 3 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 60986-1019_4244a7ce-fd9b-4466-ac3f-8ac81f650a0f 60986-1019 HUMAN OTC DRUG Lithium Lithium Bromatum LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. LITHIUM BROMIDE 3 [hp_X]/mL E 20171231 60986-1020_dc3049d1-482b-4804-ab6e-0cbfa37957f3 60986-1020 HUMAN OTC DRUG Solidago Solidago Virgaurea, Uva-Ursi, Pareira Brava, Sabal Serrulata, Populus Tremuloides, Staphysagria, Cantharis, Terebinthia, Borax LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SAW PALMETTO; POPULUS TREMULOIDES BARK; DELPHINIUM STAPHISAGRIA SEED; LYTTA VESICATORIA; LARIX DECIDUA RESIN; SODIUM BORATE 1; 1; 3; 1; 2; 3; 4; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 60986-1021_d9f66e0a-0f79-43af-b59e-b2984e9a8850 60986-1021 HUMAN PRESCRIPTION DRUG CACTUS CACTUS GRANDIFLORUS, CONVALLARIA MAJALIS, CRATAEGUS LAEVIGATA, CAMPHORA, KALMIA LATIFOLIA, SPIGELIA ANTHELMIA, LACHESIS MUTUS, ARNICA MONTANA,TABACUM, GLONOINUM LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; CRATAEGUS LAEVIGATA WHOLE; CAMPHOR (NATURAL); KALMIA LATIFOLIA LEAF; SPIGELIA ANTHELMIA; LACHESIS MUTA VENOM; ARNICA MONTANA; TOBACCO LEAF; NITROGLYCERIN 2; 3; 1; 2; 4; 4; 8; 6; 8; 8 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 60986-1022_c953c7dc-64cb-4a0a-9083-2c6c128e120b 60986-1022 HUMAN OTC DRUG Polygonum Polygonum Aviculare, Acorus Calamus, Rhus Toxicodendron, Gnaphalium Polycephalum, Rhododendron Chrysanthum, Colocynthis, Colchicum Autumnale, Kali Iodatum, Ichthyolum, Symphytum Officinale LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. POLYGONUM AVICULARE TOP; ACORUS CALAMUS WHOLE; TOXICODENDRON PUBESCENS LEAF; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RHODODENDRON AUREUM LEAF; CITRULLUS COLOCYNTHIS FRUIT PULP; COLCHICUM AUTUMNALE BULB; POTASSIUM IODIDE; ICHTHAMMOL; COMFREY ROOT 1; 1; 4; 2; 3; 3; 3; 4; 3; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 60986-1024_260ad90d-3415-405a-a936-28450c1c7f9a 60986-1024 HUMAN OTC DRUG Female Tonic Alchemilla Vulgaris, Asperula Odorata, Chamomilla, Viola Odorata, Cinchona Officinalis, Mentha Piperita, Rosmarinus Officinalis, Valeriana Officinalis, Helonia Dioica, Agnus Castus, Ambra Grisea, Cimi LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ALCHEMILLA XANTHOCHLORA FLOWERING TOP; GALIUM ODORATUM; MATRICARIA RECUTITA; VIOLA ODORATA; CINCHONA OFFICINALIS BARK; MENTHA PIPERITA; ROSMARINUS OFFICINALIS FLOWERING TOP; VALERIAN; CHAMAELIRIUM LUTEUM ROOT; CHASTE TREE; AMBERGRIS; BLACK COHOSH; CONVALLARIA MAJALIS; SAFFRON; CYCLAMEN PURPURASCENS TUBER; TURNERA DIFFUSA LEAFY TWIG; GOLDENSEAL; CAULOPHYLLUM THALICTROIDES ROOT; LILIUM LANCIFOLIUM FLOWERING TOP; PACKERA AUREA; DELPHINIUM STAPHISAGRIA SEED; NAJA NAJA VENOM 1; 1; 1; 1; 2; 1; 1; 1; 2; 3; 3; 3; 3; 3; 3; 3; 3; 4; 4; 4; 4; 8 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 60986-1026_edbc49a2-5110-44e8-8e3e-40201f1c875d 60986-1026 HUMAN OTC DRUG LYCOPUS LYCOPUS VIRGINICUS, SPONGIA TOSTA, LOPHOPHYTUM LEANDRII, CHININUM ARSENICOSUM, CALCAREA PHOSPHORICA, MAGNESIA PHOSPHORICA LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. LYCOPUS VIRGINICUS; SPONGIA OFFICINALIS SKELETON, ROASTED; LOPHOPHYTUM LEANDRII; QUININE ARSENITE; TRIBASIC CALCIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 1; 1; 6; 6; 8; 8 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 60986-1027_3129c2dd-5d54-48ce-8c84-7e779ba96a6d 60986-1027 HUMAN OTC DRUG Aesculus Potentilla Anserina, Aesculus Hippocastanum, Ustilago Maidis, Secale Cornutum, Ruta Graveolens LIQUID ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ARGENTINA ANSERINA FLOWERING TOP; HORSE CHESTNUT; USTILAGO MAYDIS; CLAVICEPS PURPUREA SCLEROTIUM; RUTA GRAVEOLENS WHOLE 1; 1; 5; 4; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 60986-2000_1084b58e-310d-46c1-8a6c-0680132ba6e4 60986-2000 HUMAN OTC DRUG ECHINACEA ECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LAC TABLET, ORALLY DISINTEGRATING ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TRIBASIC CALCIUM PHOSPHATE; GOLDENSEAL; POLYGALA SENEGA ROOT; SILICON DIOXIDE; CONIUM MACULATUM FLOWERING TOP; SODIUM TETRACHLOROAURATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FUCUS VESICULOSUS; LACHESIS MUTA VENOM 1; 2; 3; 4; 4; 4; 4; 5; 5; 5; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 60986-2025_10564b75-239a-4415-a461-14c928a621f6 60986-2025 HUMAN OTC DRUG Luffa Luffa, Hydrastis Canadensis, Mercurius Sulph. Rub, Allium Cepa, Natrum Muriticum, Phosphorus, Eupatorium Perf, Sticta TABLET, ORALLY DISINTEGRATING ORAL 19920301 UNAPPROVED HOMEOPATHIC Marco Pharma International LLC. LUFFA ACUTANGULA FRUIT; GOLDENSEAL; MERCURIC SULFIDE; ONION; SODIUM CHLORIDE; PHOSPHORUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; LOBARIA PULMONARIA 6; 4; 4; 6; 6; 6; 5; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 60986-2030_85df68e2-d53a-4087-a929-d275a26d6233 60986-2030 HUMAN OTC DRUG ABB ACONITUM NAPELLUS, BRYONIA ALBA, BELLADONNA LIQUID ORAL 20150122 UNAPPROVED HOMEOPATHIC MARCO PHARMA INTERNATIONAL LLC ACONITUM NAPELLUS; BRYONIA ALBA WHOLE; BELLADONNA LEAF 3; 3; 3 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 60986-2035_b9eccacd-32d0-4a1f-b13f-9faa8ca206cb 60986-2035 HUMAN OTC DRUG ABC ACONITUM NAPELLUS, BELLADONNA, CHAMOMILLA LIQUID ORAL 20150122 UNAPPROVED HOMEOPATHIC MARCO PHARMA INTERNATIONAL LLC ACONITUM NAPELLUS; MATRICARIA RECUTITA; BELLADONNA LEAF 3; 3; 3 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL E 20171231 61010-1111_688a8109-a56b-4366-8af4-759b440aa0e9 61010-1111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 540.26 g/L N 20181231 61010-1111_982a523e-247d-4bc5-87ff-1bd89df2dac3 61010-1111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 540.26 g/L N 20181231 61010-1112_8cfb1b18-4e00-4265-87f5-a0971372d1e0 61010-1112 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333E Safetec of America ALCOHOL 665 mL/L N 20181231 61010-1112_b5d69c84-385d-4b48-a8bc-f00352cb4a2e 61010-1112 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20120322 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mL/L N 20181231 61010-1112_f061e83d-b73c-42d4-a7f4-849d47394b31 61010-1112 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part333E Safetec of America ALCOHOL 665 mL/L N 20181231 61010-1122_2b5fea32-9707-453d-b272-bf09e500bd68 61010-1122 HUMAN OTC DRUG Saniwash Antimicrobial Chloroxylenol LIQUID TOPICAL 20140422 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. CHLOROXYLENOL .006 mg/mL N 20181231 61010-1250_02e4e200-08ec-4fa3-9078-c6855f945389 61010-1250 HUMAN OTC DRUG Ice menthol GEL TOPICAL 20140818 OTC MONOGRAPH NOT FINAL part348 Safetec of America, Inc MENTHOL 34.79 mg/mL N 20181231 61010-2017_d016943c-0f91-469d-9947-65050981adab 61010-2017 HUMAN OTC DRUG Antiseptic alcohol CLOTH TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mL/L N 20181231 61010-2111_0f38e341-1a4b-41c4-99b9-e1df2f8077e8 61010-2111 HUMAN OTC DRUG A.B.H.C. Instant Hand Sanitizer Citrus Scent alcohol GEL TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mL/L N 20181231 61010-2111_1a990ed0-e492-4a26-b747-cf832d485314 61010-2111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 540.26 g/L N 20181231 61010-2111_de0ffa20-d280-4625-9c27-bb8ceeaff477 61010-2111 HUMAN OTC DRUG A.B.H.C. Instant Hand Sanitizer Citrus Scent alcohol GEL TOPICAL 20100501 OTC MONOGRAPH FINAL part333 Safetec of America, Inc. ALCOHOL 665 mL/L N 20181231 61010-3111_da433793-4e8f-403d-a59c-59ef68abb533 61010-3111 HUMAN OTC DRUG Antimicrobial alcohol LIQUID TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mL/L N 20181231 61010-3112_cd32e18d-c5fc-43b7-8536-9514536aea89 61010-3112 HUMAN OTC DRUG Antibacterial alcohol LIQUID TOPICAL 20110502 OTC MONOGRAPH NOT FINAL part333E Safetec of America ALCOHOL 665 mL/L N 20181231 61010-3200_86bb8108-bb10-42f4-a848-96d7d3d8f17d 61010-3200 HUMAN OTC DRUG Antimicrobial alcohol LIQUID TOPICAL 20110307 OTC MONOGRAPH NOT FINAL part333E Safetec of America ALCOHOL 665 mL/L N 20181231 61010-3300_ad081a6d-f23b-4889-955a-067f6b424b53 61010-3300 HUMAN OTC DRUG Antimicrobial alcohol LIQUID TOPICAL 20131213 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mg/L N 20181231 61010-4111_4c651bef-b3e8-47a0-8801-ddeebbbf3b1f 61010-4111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20101216 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL .7 g/mL N 20181231 61010-4111_61b46712-2151-4e32-8f25-141c3cbddc04 61010-4111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20100915 OTC MONOGRAPH NOT FINAL part333E Safetec of America ALCOHOL .7 g/mL N 20181231 61010-5000_c12eb7d1-1118-49a2-b9b0-244556920e50 61010-5000 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride GEL TOPICAL 20120919 OTC MONOGRAPH NOT FINAL part348 Safetec of America, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/g N 20181231 61010-5100_2df5b2b2-343a-4c5e-ac31-fa4fa7206085 61010-5100 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride LIQUID TOPICAL 20110802 OTC MONOGRAPH NOT FINAL part348 Safetec of America, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL N 20181231 61010-5111_d6138e2e-98eb-4fc7-bea2-600dcc8a4f57 61010-5111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mg/L N 20181231 61010-5200_8792eaa2-5fd8-41fa-8cfc-b00614c115fe 61010-5200 HUMAN OTC DRUG Antiseptic alcohol, lidocaine hydrochloride LIQUID TOPICAL 20110930 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL; LIDOCAINE HYDROCHLORIDE 500; 20 mg/g; mg/g N 20181231 61010-5300_ca6e7215-80cc-408a-a7ad-2748f3fc6b3a 61010-5300 HUMAN OTC DRUG Antiseptic benzalkonium chloride, benzocaine SPRAY TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 mg/g; mg/g N 20181231 61010-5400_1abe5da8-6f91-4fb6-bc8f-8e618e68a5db 61010-5400 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20120216 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. HYDROGEN PEROXIDE 30 mg/mL N 20181231 61010-5500_64c27eab-58fa-40fe-abc5-72d0f436b46f 61010-5500 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20120216 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. ISOPROPYL ALCOHOL 700 mL/L N 20181231 61010-5600_b9969bb4-4a06-41ca-96b3-52542eb19c67 61010-5600 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20110808 OTC MONOGRAPH FINAL part333B Safetec of America, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 61010-5601_218af647-1042-4a89-b024-18a0e8a4a3fd 61010-5601 HUMAN OTC DRUG Single Antibiotic with bacitracin bacitracin zinc OINTMENT TOPICAL 20081113 OTC MONOGRAPH FINAL part333B Safetec of America BACITRACIN ZINC 400 [USP'U]/g N 20181231 61010-5603_f7a6a707-f75d-4571-9721-031518f2bea4 61010-5603 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20070330 OTC MONOGRAPH FINAL part333B Safetec of America, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 61010-5701_bea02d7c-ba3e-4966-a8ca-20720299149a 61010-5701 HUMAN OTC DRUG First Aid and Burn Benzalkonium Chloride, Lidocaine Hydrochloride CREAM TOPICAL 20120921 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g N 20181231 61010-5800_6164b28b-c156-47d3-9652-7f7e453ef917 61010-5800 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20101215 OTC MONOGRAPH NOT FINAL part348 Safetec of America, Inc. HYDROCORTISONE 10 mg/g N 20181231 61010-6103_0d7f63ee-36e2-4e1b-bb68-7f3e2461aab6 61010-6103 HUMAN OTC DRUG Sunscreen Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20070313 OTC MONOGRAPH NOT FINAL part352 Safetec of America, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 6; 7.5; 5; 5 mg/g; mg/g; mg/g; mg/g N 20181231 61010-6111_d3c94548-eea9-4291-9ca4-f29bfd860e16 61010-6111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20131111 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 700 mg/L N 20181231 61010-6700_5bfce14f-7a05-4b44-a8bd-0bba11fe4e3c 61010-6700 HUMAN OTC DRUG Single Antibiotic with Neomycin neomycin sulfate OINTMENT TOPICAL 20081113 OTC MONOGRAPH FINAL part333B Safetec of America NEOMYCIN SULFATE 3.5 mg/g N 20181231 61010-7000_188fff36-2829-4077-8115-bb90e0c25bbb 61010-7000 HUMAN OTC DRUG Antiseptic isopropyl alcohol LIQUID TOPICAL 20110502 OTC MONOGRAPH NOT FINAL part333A Safetec of America ISOPROPYL ALCOHOL 715 mL/L N 20181231 61010-7100_8acf1da5-9b48-4f06-a454-f0d7700da6cd 61010-7100 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20110505 OTC MONOGRAPH NOT FINAL part333E Safetec of America BENZALKONIUM CHLORIDE 1.3 mL/L N 20181231 61010-7110_3d303415-56fe-4445-82ed-bb2b40651430 61010-7110 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20110712 OTC MONOGRAPH NOT FINAL part333E Safetec of America BENZALKONIUM CHLORIDE 1.3 mL/L N 20181231 61010-7111_8ff67b75-9bdb-4fb2-9876-e3ec7cdb9f72 61010-7111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20131106 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 700 mg/L N 20181231 61010-7200_de1cfe9e-2cd4-4ed5-b499-1184e66fc558 61010-7200 HUMAN OTC DRUG Antiseptic alcohol, benzocaine LIQUID TOPICAL 20110512 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL; BENZOCAINE 500; 60 mg/g; mg/g N 20181231 61010-8100_ec1e9e72-8cd4-459d-a7c0-dcffa3dfa6e9 61010-8100 HUMAN OTC DRUG Pain Relief benzocaine LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part356 Safetec of America, Inc. BENZOCAINE 200 mg/g N 20181231 61010-8111_a29ec6dc-e395-43be-9c8a-5532f0441999 61010-8111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20150219 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 700 mg/L N 20181231 61010-8200_5be909cf-57fe-4831-a6bb-7bfd82c732e6 61010-8200 HUMAN OTC DRUG Analgesic menthol SPRAY TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part348 Safetec of America, Inc. MENTHOL 700 mL/L N 20181231 61010-8300_008112db-7e33-4763-9784-9a958bcb71e6 61010-8300 HUMAN OTC DRUG Itch Relief diphenhydramine hydrochloride LIQUID TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part348 Safetec of America, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 20.3 g/L N 20181231 61010-8400_dc98202d-8a86-4b94-bdf1-e6a70e0bacac 61010-8400 HUMAN OTC DRUG Hand Sanitizer benzalkonium chloride LIQUID TOPICAL 20140114 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. BENZALKONIUM CHLORIDE 1 mg/L N 20181231 61010-8600_232026a8-e157-4e6a-ae97-e10226d10372 61010-8600 HUMAN OTC DRUG Saniwash Antimicrobial Foaming Hand Chloroxylenol LIQUID TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part333A Safetec of America, Inc. CHLOROXYLENOL .006 g/mL N 20181231 61010-8700_315ad1cc-5f75-4bc2-ba0a-59633173e11f 61010-8700 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333E Safetec of America, Inc. ALCOHOL 665 mg/L N 20181231 61012-010_2801a538-d18f-328e-e054-00144ff88e88 61012-010 HUMAN OTC DRUG Dr. Teals Pre and Post Workout Pain Relief Menthol CREAM TOPICAL 20150210 OTC MONOGRAPH NOT FINAL part348 PDC Brands MENTHOL 100 mg/g N 20181231 61016-0001_5a8dc127-a9c9-4aca-a3da-e53f5fbea2c9 61016-0001 HUMAN OTC DRUG Anti-Aging Tinted Moisturizer Broad Spectrum SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20120223 OTC MONOGRAPH FINAL part352 Columbia Cosmetics Manufacturing, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 61016-0002_bc2e7941-806c-40e0-8734-2569f6fdbe80 61016-0002 HUMAN OTC DRUG Antioxidant Day SPF 15 OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20120419 OTC MONOGRAPH FINAL part352 Columbia Cosmetics Manufacturing, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 3; 3 mL/100mL; mL/100mL; mL/100mL N 20181231 61016-0003_e26b4334-5aa8-435d-913b-bf7774cadfa9 61016-0003 HUMAN OTC DRUG Anti-Aging Daily Moisturizer Sunscreen Broad-Spectrum SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20120419 OTC MONOGRAPH FINAL part352 Columbia Cosmetics Manufacturing, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 4 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 61016-0004_baa007e7-9662-4bd3-95a3-cad8b8c2e649 61016-0004 HUMAN OTC DRUG the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum lighter than light OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20130729 OTC MONOGRAPH NOT FINAL part352 Columbia Cosmetics Manufacturing, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 75; 30; 30 mg/mL; mg/mL; mg/mL N 20181231 61016-0005_3f94c2f3-0746-434d-beea-00ff07b3ae9d 61016-0005 HUMAN OTC DRUG the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum medium dark OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20130729 OTC MONOGRAPH NOT FINAL part352 Columbia Cosmetics Manufacturing, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 75; 30; 30 mg/mL; mg/mL; mg/mL N 20181231 61016-0006_125a52e7-5748-4c2e-93d2-303c30cba204 61016-0006 HUMAN OTC DRUG the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum dark OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20130729 OTC MONOGRAPH NOT FINAL part352 Columbia Cosmetics Manufacturing, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 75; 30; 30 mg/mL; mg/mL; mg/mL N 20181231 61016-0007_d934600b-51c9-4ff3-8a5a-c5a4ade85bc2 61016-0007 HUMAN OTC DRUG the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum after dark OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20130729 OTC MONOGRAPH NOT FINAL part352 Columbia Cosmetics Manufacturing, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 75; 30; 30 mg/mL; mg/mL; mg/mL N 20181231 61034-001_326f2582-93b3-2d1f-e054-00144ff8d46c 61034-001 HUMAN OTC DRUG Chemisphere Hand Sanitizer Hand Sanitizer GEL TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part333A Chemisphere Corp ALCOHOL 63 mL/100mL N 20181231 61037-412_064ea004-3f4c-1633-e054-00144ff88e88 61037-412 HUMAN OTC DRUG Scrub Chlorhexidine Gluconate SOLUTION TOPICAL 20140930 NDA NDA020111 Bajaj Medical, LLC CHLORHEXIDINE GLUCONATE .75 mg/100mL N 20181231 61037-413_064ea004-3f5c-1633-e054-00144ff88e88 61037-413 HUMAN OTC DRUG Dyna-Hex 75 Antiseptic Handwash SOLUTION TOPICAL 20140930 NDA NDA020111 Bajaj Medical, LLC CHLORHEXIDINE GLUCONATE .75 mg/100mL N 20181231 61037-421_4be6ce23-e722-510e-e054-00144ff8d46c 61037-421 HUMAN OTC DRUG Scrub, Scrub-Stat Chlorhexidine gluconate SOLUTION TOPICAL 19860722 NDA NDA019258 Bajaj Medical, LLC CHLORHEXIDINE GLUCONATE 40 mg/mL N 20181231 61041-211_07ceb03e-9994-498c-a020-d7f17f9da10b 61041-211 HUMAN OTC DRUG XEROSTOM SODIUM FLUORIDE MOUTHWASH ORAL 20131115 OTC MONOGRAPH FINAL part355 Bio Cosmetics SODIUM FLUORIDE .559 mg/mL N 20181231 61041-211_447b0604-4b92-4458-b65e-1b4a3864e416 61041-211 HUMAN OTC DRUG XEROSTOM SODIUM FLUORIDE MOUTHWASH ORAL 20150206 OTC MONOGRAPH FINAL part355 Bio Cosmetics SODIUM FLUORIDE .559 mg/mL N 20181231 61041-212_6ac32867-7997-4ac9-b70a-5959c352bc53 61041-212 HUMAN OTC DRUG XEROSTOM SODIUM FLUORIDE PASTE ORAL 20131108 OTC MONOGRAPH FINAL part355 Bio Cosmetics S L SODIUM FLUORIDE 2.2 mg/g N 20181231 61041-212_cbfac672-a44e-4009-939f-92fd139771f3 61041-212 HUMAN OTC DRUG XEROSTOM SODIUM FLUORIDE PASTE ORAL 20150206 OTC MONOGRAPH FINAL part355 Bio Cosmetics S L SODIUM FLUORIDE 2.2 mg/g N 20181231 61045-0001_753319dd-5c98-4d20-869a-47624b4be42d 61045-0001 HUMAN OTC DRUG ARTHRONEW AM NOT APPLICABLE GEL TOPICAL 20141103 UNAPPROVED HOMEOPATHIC PureCore Wellness, Inc. COMFREY ROOT; CAPSICUM; LEDUM PALUSTRE TWIG; COLCHICUM AUTUMNALE BULB; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP 3; 6; 6; 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 61045-0002_8a5c6964-70ba-41ef-940f-bd40f4407e2b 61045-0002 HUMAN OTC DRUG ARTHRONEW PM NOT APPLICABLE GEL TOPICAL 20141103 UNAPPROVED HOMEOPATHIC PureCore Wellness, Inc ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 61047-770_ca1d569d-ac58-4351-a9ca-b3a86613abe1 61047-770 HUMAN OTC DRUG Close Up Anticavity Toothpaste Anticavity Toothpaste GEL DENTAL 20100325 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products SODIUM FLUORIDE .27 g/113.4g N 20181231 61047-771_dec0bb47-280a-4c76-9aeb-fb3164af043d 61047-771 HUMAN OTC DRUG Close Up Anticavity Toothpaste Anticavity Toothpaste GEL DENTAL 20100326 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products SODIUM FLUORIDE .54 g/226.8g N 20181231 61047-810_42ebf49c-9b98-4b0a-bbe9-22d0c60b8a5b 61047-810 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100312 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .58; 5.8; 2.9; .464; 2.32 mL/58mL; mL/58mL; mL/58mL; mL/58mL; mL/58mL N 20181231 61047-811_98665009-5a5a-459d-8c42-47b44ffbe205 61047-811 HUMAN OTC DRUG Banana Boat Ultra Defense Broad Spectrum Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100323 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.36; 35.4; 11.8; 2.95; 14.16 mL/236mL; mL/236mL; mL/236mL; mL/236mL; mL/236mL N 20181231 61047-812_1e980e64-1b5a-4227-8c2e-9afa94c596fb 61047-812 HUMAN OTC DRUG Banana Boat Ultra Defense Sheer Protect Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100319 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.36; 23.6; 11.8; 1.88; 9.44 mL/236mL; mL/236mL; mL/236mL; mL/236mL; mL/236mL N 20181231 61047-813_3433e103-1c18-468e-96c9-ed32332a94b0 61047-813 HUMAN OTC DRUG Banana Boat Sport Performance Active Dry protect Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100319 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.95; 29.5; 14.75; 2.36; 11.8 mL/295mL; mL/295mL; mL/295mL; mL/295mL; mL/295mL N 20181231 61047-814_fe2ca488-fe49-461d-af82-8bb89de56b24 61047-814 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100322 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .88; 8.8; 4.4; .7; 3.52 mL/88mL; mL/88mL; mL/88mL; mL/88mL; mL/88mL N 20181231 61047-815_98ef9f27-5f50-4a44-b1b4-ac2470a72ef5 61047-815 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100322 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .88; 8.85; 2.95; .74; 3.54 mL/59mL; mL/59mL; mL/59mL; mL/59mL; mL/59mL N 20181231 61047-816_75cc4822-8c8d-41f7-ace7-0988026da845 61047-816 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100322 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.95; 29.5; 14.75; 2.36; 11.8 mL/295mL; mL/295mL; mL/295mL; mL/295mL; mL/295mL N 20181231 61047-817_c80e1e77-def8-40e9-bbd3-dfc2cb9428df 61047-817 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100323 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.36; 23.6; 11.8; 1.88; 9.44 mL/236mL; mL/236mL; mL/236mL; mL/236mL; mL/236mL N 20181231 61047-818_beb678fe-ac79-4353-ac35-94035f12af94 61047-818 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100323 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 2.36; 14.16; 1.88; 4.72 mL/236mL; mL/236mL; mL/236mL; mL/236mL N 20181231 61047-819_2fd4c631-d6f4-4827-a296-750d6466b29e 61047-819 HUMAN OTC DRUG Banana Boat Ultra Defense Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100325 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3.54; 35.4; 11.8; 2.95; 14.16 mL/236mL; mL/236mL; mL/236mL; mL/236mL; mL/236mL N 20181231 61047-820_99e5b34c-12a1-4131-96c5-60647246ceef 61047-820 HUMAN OTC DRUG Banana Boat Sport Performance Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100325 OTC MONOGRAPH NOT FINAL part348 KIK Custom Products AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .59; 5.9; 2.95; .47; 2.36 mL/59mL; mL/59mL; mL/59mL; mL/59mL; mL/236mL N 20181231 61047-824_5700f991-5c7c-4729-8e7b-c59606d57eb0 61047-824 HUMAN OTC DRUG Purpose Sunscreen Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20130408 OTC MONOGRAPH NOT FINAL part352 KIK Custom Products OCTINOXATE; OCTISALATE; OXYBENZONE 9; 6; 3.6 g/120g; g/120g; g/120g N 20181231 61047-831_352d444d-a1d4-4a9f-9d60-c3f4eac4f165 61047-831 HUMAN OTC DRUG Banana Boat Sport Performance Active Dry Protect SPF UVB 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part352 KIK Custom Products HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 53.1; 17.7; 4.42; 17.7; 5.31 mL/354mL; mL/354mL; mL/354mL; mL/354mL; mL/354mL N 20181231 61062-0001_6523cd79-6726-4aab-aab7-fded1103f772 61062-0001 HUMAN OTC DRUG D1 Organ Support Carduus Marianus, Chelidonium Majus, Cinchona Officinalis, Lycopodium Clavatum, Taraxacum Officinale, Veratrum Album, Avena Sativa, Cynara Scolymus, Methylcobalamin, Menadione, Alpha Lipoicum Acidum, Hepar Suis, Colon (suis), Duodenum (suis), Gallbladder (suis), Intestine (suis), Lymph Nodes (suis), Pancreas Suis, Thymus (suis), Alpha Ketoglutaricum Acidum, Cholesterinum, Formicum Acidum, Glyoxal Trimer Dihydrate, Histaminum Hydrochloricum, Malic Acid, Natrum Oxalaceticum, Sulphur LIQUID ORAL 20140806 20190701 UNAPPROVED HOMEOPATHIC Restivo Chiropractic MILK THISTLE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT; AVENA SATIVA FLOWERING TOP; CYNARA SCOLYMUS LEAF; METHYLCOBALAMIN; MENADIONE; .ALPHA.-LIPOIC ACID; PORK LIVER; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; PORK INTESTINE; SUS SCROFA LYMPH; SUS SCROFA PANCREAS; SUS SCROFA THYMUS; .ALPHA.-KETOGLUTARIC ACID; CHOLESTEROL; FORMIC ACID; GLYOXAL TRIMER DIHYDRATE; HISTAMINE DIHYDROCHLORIDE; MALIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; OROTIC ACID MONOHYDRATE; PROTEUS MORGANII; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 3; 4; 4; 4; 4; 4; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 13; 28; 7; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 61062-0002_71292860-8754-427f-8cd7-53dc03e66f7e 61062-0002 HUMAN OTC DRUG D2 Organ Support Solidago Virgaurea, Baptisia Tinctoria, Berberis Vulgaris, Equisetum Hyemale, Argentum Nitricum, Cantharis, Capsicum Annuum, Cuprum Sulphuricum, Orthosiphon Stamineus, Pareira Brava, Sarsaparilla (Smilax Regelii), Terebinthina, Apis Venenum Purum, Barosma (Betulina), Mercurius Corrosivus, Pyelon (Suis), Ureter (Suis), Urethra (Suis), Urinary Bladder (Suis), Glyoxal Trimer Dihydrate, Hepar Sulphuris Calcareum, Natrum Pyruvicum, Quercetin, Colibacillinum Cum Natrum Muriaticum, Dysentery Bacillus LIQUID ORAL 20140806 20190714 UNAPPROVED HOMEOPATHIC Restivo Chiropractic SOLIDAGO VIRGAUREA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; SILVER NITRATE; LYTTA VESICATORIA; CAPSICUM; CUPRIC SULFATE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; TURPENTINE OIL; APIS MELLIFERA VENOM; AGATHOSMA BETULINA LEAF; MERCURIC CHLORIDE; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; GLYOXAL TRIMER DIHYDRATE; CALCIUM SULFIDE; SODIUM PYRUVATE; QUERCETIN; ESCHERICHIA COLI; SHIGELLA DYSENTERIAE 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 61062-0003_a4fa60ea-66e9-4295-acbd-7fb1fb10590a 61062-0003 HUMAN OTC DRUG D3 Organ Support Conium Maculatum, Dulcamara, Echinacea, Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid, Coccus Cacti, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Pulsatilla (Vulgaris), Sarcolacticum Acidum, Lymph (suis), Sulphur, Glandula Suprarenalis Suis, Phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (suis), Spleen (suis), Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Funiculus Umbilicalis Suis, Tonsil (suis), Gaertner Bacillus (Bach) LIQUID ORAL 20140806 20190701 UNAPPROVED HOMEOPATHIC Restivo Chiropractic CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA ANGUSTIFOLIA; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; PULSATILLA VULGARIS; LACTIC ACID, L-; SUS SCROFA LYMPH; SULFUR; SUS SCROFA ADRENAL GLAND; PHENYLALANINE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA SPLEEN; CORTISONE ACETATE; MERCURIUS SOLUBILIS; BARIUM CARBONATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA TONSIL; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; LIOTHYRONINE; SUS SCROFA BONE MARROW; BISPHENOL A; BROMINE; CHLORINE; HYDROFLUORIC ACID; IODINE; ESCHERICHIA COLI 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 10; 10; 10; 10; 10; 13; 13; 28; 6; 6; 9; 10; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 61062-0004_1225d5ac-04f8-4a08-8caf-ae40cf5b405c 61062-0004 HUMAN OTC DRUG Brain Support not applicable LIQUID ORAL 20140811 20190701 UNAPPROVED HOMEOPATHIC Restivo Chiropractic ACETYLCHOLINE CHLORIDE; EPINEPHRINE; DOPAMINE HYDROCHLORIDE; .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; TAURINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 61062-0006_bd91cb0b-ae7b-43fc-a242-c2fc66f43209 61062-0006 HUMAN OTC DRUG Insecticides and Pest and Food Additives Detox Beta Vulgaris, Boldo, Chelidonium Majus, Petroselinum Sativum, Taraxacum Officinale, Arsenicum Album, Belladonna, Cobaltum Metallicum, Cuprum Metallicum, Iodium, Lycopodium Clavatum, Phosphoricum Acidum, Selenium Metallicum, Zincum Metallicum, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methyl Paraben, Propyl Paraben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum LIQUID ORAL 20140805 20190805 UNAPPROVED HOMEOPATHIC Restivo Chiropractic BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; PETROSELINUM CRISPUM; TARAXACUM OFFICINALE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; COBALT; COPPER; IODINE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SELENIUM; ZINC; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 61062-0007_9742681a-8afb-4761-b29d-708da5a65760 61062-0007 HUMAN OTC DRUG METDETOX Allium sativum, Berberis vulgaris, Glycyrrhiza glabra, Lappa Major, Phytolacca decandra, Stillingia sylvatica, Trifolium pratense, Ascorbic acid, LIQUID ORAL 20131210 20190701 UNAPPROVED HOMEOPATHIC Restivo Chiropractic GARLIC; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ASCORBIC ACID; CYSTEINE; IRIDIUM; METHIONINE; SELENIUM; THYROID, PORCINE; ARSENIC TRIOXIDE; PHENOL; FORMALDEHYDE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; ANTIMONY TRISULFIDE; ALUMINUM; SILVER; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 112; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 61062-0008_c86c8e55-c9ce-4ad5-8d54-f73ada7e6e9b 61062-0008 HUMAN OTC DRUG Intercellular Detox not applicable LIQUID ORAL 20140805 20190701 UNAPPROVED HOMEOPATHIC Restivo Chiropractic CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS MONTANA LEAF; PULSATILLA VULGARIS; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTUM; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; ATROPA BELLADONNA; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 4; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 61062-0009_8bbfe83e-708e-4105-9974-5f34d64a8a24 61062-0009 HUMAN OTC DRUG NS Support not applicable LIQUID ORAL 20140805 20190701 UNAPPROVED HOMEOPATHIC Restivo Chiropractic BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; CUPRIC ACETATE; NADIDE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PICRIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; .ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; COENZYME A; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SUS SCROFA BONE MARROW; MERCURIC OXIDE; SULFUR; ENTEROBACTER CLOACAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII; PROTEUS VULGARIS 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 28; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 61062-0010_0937ef4e-4a6c-4f82-9de4-6d1cf8b15e3b 61062-0010 HUMAN OTC DRUG WLP40 Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Brain (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), Aacg-A, Aacg-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto Dhea (Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum, Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20140804 20190820 UNAPPROVED HOMEOPATHIC Restivo Chiropractic CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; PRASTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 61065-1002_7f5e6399-bf6d-430d-89a9-a2092fc9f8c6 61065-1002 HUMAN OTC DRUG SUPER MIRAPHARM (0.3g) PANAX QUINQUEFOLIUS (Red Ginseng) CAPSULE ORAL 20150131 UNAPPROVED DRUG OTHER MIRAPHARM., Inc. PANAX QUINQUEFOLIUS WHOLE .0006 g/1 E 20171231 61065-1003_47e93ecf-ccad-6b48-e054-00144ff8d46c 61065-1003 HUMAN OTC DRUG SUPER MEDIPHARM PANAX GINSENG WHOLE CAPSULE ORAL 20131118 UNAPPROVED DRUG OTHER Mirapharm Inc PANAX GINSENG WHOLE .3 g/1 N 20181231 61065-2001_17360727-00c3-4d1d-8bef-6c3e7a0c3bc4 61065-2001 HUMAN OTC DRUG MIRAPHARM 22 PANAX QUINQUEFOLIUS (RED GINSENG) CAPSULE ORAL 20150206 UNAPPROVED DRUG OTHER MIRAPHARM., Inc. PANAX QUINQUEFOLIUS WHOLE .06 g/1 E 20171231 61077-001_33480d1d-e2b4-45fa-9398-4c9a9d37a66f 61077-001 HUMAN OTC DRUG H-Warts Formula Phytolacca decandra, Thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 12; 12 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-003_2df8a87d-63f3-4a56-9eeb-1e244f7747c5 61077-003 HUMAN OTC DRUG H-Hemorrhoids Formula Aesculus hippocastanum, Collinsonia canadensis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils AESCULUS HIPPOCASTANUM FLOWER; COLLINSONIA CANADENSIS ROOT 12; 12 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-005_b6a0fff6-0ded-49d8-be48-a2a2d17bcd53 61077-005 HUMAN OTC DRUG H-BI Hemorrhoids Formula calendula officinallis, hamamelis virginiana OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 12; 6 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-011_fbdf4890-a189-4fbf-baef-e077677c2b79 61077-011 HUMAN OTC DRUG H-Shingles Formula calendula officinalis, iris versicolor, ranunculus bulbosus OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils CALENDULA OFFICINALIS FLOWERING TOP; IRIS VERSICOLOR ROOT; RANUNCULUS BULBOSUS 12; 12; 12 [hp_C]/11mL; [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-019_3c2fb525-15ec-4666-944f-00db6b4ae3f0 61077-019 HUMAN OTC DRUG H- Eczema Formula anacardium orientale, iris versicolor OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils SEMECARPUS ANACARDIUM JUICE; IRIS VERSICOLOR ROOT 12; 12 [hp_C]/11mL; [hp_C]/11mL N 20191231 61077-020_8d32a590-f3d8-4237-b0dd-6a94389dc1d2 61077-020 HUMAN OTC DRUG H-Acne Formula calendula officinalis, nux vomica, silicea OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE 12; 12; 12 [hp_C]/11mL; [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-021_0fd474ab-5177-438d-bcb5-30dad4090ae0 61077-021 HUMAN OTC DRUG H-Athletes Foot Formula calendula officinalis, lycopodium clavatum, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12 [hp_C]/11mL; [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-026_0305bb25-6fef-4309-b59f-017ba1e66ab7 61077-026 HUMAN OTC DRUG H-Molluscum Formula calendula officinalis, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 12; 12 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-028_b5c33f8d-e9c9-4d40-bfe4-824a791a201d 61077-028 HUMAN OTC DRUG H-Skin Tags Formula calendula officinalis, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 12; 12 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-034_4740d10b-0449-43de-b057-ae3772c33ed6 61077-034 HUMAN OTC DRUG H-Arthritis Formula apium graveolens, arnica montana OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CELERY SEED; ARNICA MONTANA 12; 12 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-036_efb6fcab-fd09-4d35-ac13-909cb0d9a9d8 61077-036 HUMAN OTC DRUG H-Fissures Formula calendula officinalis, chamomilla OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA 12; 6 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-038_e75430fd-b06b-41ce-8f15-008433a3f80d 61077-038 HUMAN OTC DRUG H-Headaches Formula apium graveolens, nux vomica OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CELERY SEED; STRYCHNOS NUX-VOMICA SEED 12; 12 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-039_024f6acd-4bd0-461d-b756-6e837e380901 61077-039 HUMAN OTC DRUG H-Scars Formula calendula officinallis, silicea OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE 12; 12 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-047_d15e69fc-84be-45be-857e-bf30584d3a71 61077-047 HUMAN OTC DRUG H-Psoriasis Formula calendula officinalis, iris versicolor OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; IRIS VERSICOLOR ROOT 12; 12 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-088_ae6f5253-fbbe-494b-bffd-bc88f0c54aa3 61077-088 HUMAN OTC DRUG H-Jock Itch Formula calendula officinalis, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 12; 12 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-096_fe3883e6-d0ec-4b3f-a824-50db14098eeb 61077-096 HUMAN OTC DRUG H-Varicose Veins Formula Aesculus hippocastanum, Collinsonia canadensis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC HORSE CHESTNUT; COLLINSONIA CANADENSIS ROOT 12; 12 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-101_c1e07d15-a070-4f94-ac02-de36b19f2374 61077-101 HUMAN OTC DRUG SP1 Formula phytolacca decandra, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 15; 15 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-117_c3a5819b-da72-49be-8d04-3bc63b5588c1 61077-117 HUMAN OTC DRUG H-Insomnia Formula apium graveolens, salvia officinalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CELERY SEED; SAGE 6; 6 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-118_60aff70b-dbd8-49a4-8d7a-c4ad61d66545 61077-118 HUMAN OTC DRUG Sleep Aid Formula apium graveolens, salvia officinalis OIL TOPICAL 20161122 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CELERY SEED; SAGE 6; 6 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-121_34491b5f-1c37-4c7d-9093-0ee74062fbc2 61077-121 HUMAN OTC DRUG H-Rosacea Formula belladonna, nux vomica OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC ATROPA BELLADONNA; STRYCHNOS NUX-VOMICA SEED 6; 12 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-123_d330fe6f-dd60-4838-b828-f02aaabfb984 61077-123 HUMAN OTC DRUG H-Nail Fungus Formula calendula officinalis, silicea, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12 [hp_C]/11mL; [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-125_70226e31-d06a-4e8f-b9ba-b0742f63ee46 61077-125 HUMAN OTC DRUG H-Moles Formula calendula officinalis, phytolacca decandra, thuja occidentalis OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12 [hp_C]/11mL; [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-127_9bc9ec72-88d7-4959-ab22-8b64863822dc 61077-127 HUMAN OTC DRUG H-Cold Sores Formula calendula officinalis, ranunculus bulbosus OIL TOPICAL 20131106 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC CALENDULA OFFICINALIS FLOWERING TOP; RANUNCULUS BULBOSUS 12; 12 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-133_ea536ed7-275d-4fbf-b7f4-627d1795b88d 61077-133 HUMAN OTC DRUG H-Age Spots Formula Thuja occidentalis OIL TOPICAL 20141029 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC THUJA OCCIDENTALIS LEAFY TWIG 12 [hp_C]/11mL N 20181231 61077-135_3542f5c4-c9c9-4301-aef7-acf8e12369b2 61077-135 HUMAN OTC DRUG H-Gout Formula Arnica montana, Rhododendron OIL TOPICAL 20141029 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC ARNICA MONTANA; RHODODENDRON AUREUM LEAF 12; 6 [hp_C]/11mL; [hp_C]/11mL N 20181231 61077-137_d4f4c4db-cca2-4d7f-b869-bc9231667875 61077-137 HUMAN OTC DRUG H-Joint and Muscle Formula Arnica montana, Bellis perennis, Chamomilla OIL TOPICAL 20160219 UNAPPROVED HOMEOPATHIC Healing Natural Oils LLC ARNICA MONTANA; BELLIS PERENNIS; MATRICARIA RECUTITA 12; 30; 6 [hp_C]/11mL; [hp_C]/11mL; [hp_C]/11mL N 20181231 61079-014_0bc4e3b7-24a6-435a-e054-00144ff88e88 61079-014 HUMAN OTC DRUG bB Medicated Pain Relieving Oil bB Medicated Pain Relieving Oil OIL PERCUTANEOUS; TOPICAL; TRANSDERMAL 20140701 OTC MONOGRAPH NOT FINAL part348 BB BIOCHEM LABORATORIES, INC. EUCALYPTUS OIL; CAPSAICIN; CAMPHOR (NATURAL); METHYL SALICYLATE; LEVOMENTHOL 15; .14; 3; 15; 12 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61079-025_0bc4e3b7-24a6-435a-e054-00144ff88e88 61079-025 HUMAN OTC DRUG bB Medicated Pain Relieving Oil bB Medicated Pain Relieving Oil OIL PERCUTANEOUS; TOPICAL; TRANSDERMAL 20141101 OTC MONOGRAPH NOT FINAL part348 BB BIOCHEM LABORATORIES, INC. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE; EUCALYPTUS OIL; CAPSAICIN 3; 12; 15; 15; .25 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 61084-125_191e49de-30e2-4579-a8ea-2b04a3995876 61084-125 HUMAN OTC DRUG Emergency Zit Treatment Acne Salicylic Acid STICK TOPICAL 20131105 OTC MONOGRAPH FINAL part358H Basic Research SALICYLIC ACID 2 g/100mL E 20171231 61084-126_56e36edb-eaa0-4856-a9f4-a1056d3a7170 61084-126 HUMAN OTC DRUG Clinical Emergency Zit Stick Acne Treatment Salicylic Acid STICK TOPICAL 20131105 OTC MONOGRAPH FINAL part358H Basic Research SALICYLIC ACID 2 g/2mL E 20171231 61095-100_d04e26e7-eb65-4f92-82c4-6d2481a874a3 61095-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19940101 UNAPPROVED MEDICAL GAS GT Industries Inc OXYGEN 990 mL/L E 20171231 61095-200_516c4c6f-b079-4565-a8e4-2e97fb2aa351 61095-200 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19940101 UNAPPROVED MEDICAL GAS GT Industries Inc NITROGEN 990 mL/L E 20171231 61095-300_20b3af9a-5d4c-4bcc-bfdc-691e2f475510 61095-300 HUMAN PRESCRIPTION DRUG Helium Helium GAS RESPIRATORY (INHALATION) 19940101 UNAPPROVED MEDICAL GAS GT Industries Inc HELIUM 990 mL/L E 20171231 61096-0001_5c97b252-9414-487d-8e67-6aab3520f36d 61096-0001 HUMAN OTC DRUG Sprayology SleepEase Aquilegia vulgaris, Avena sativa, Chamomilla, Coffea cruda, Cypripedium pubescens, Humulus lupulus, Kali phosphoricum, Passiflora incarnata, Valeriana officinalis, Zincum metallicum LIQUID ORAL 20140102 UNAPPROVED HOMEOPATHIC Eight and Company AQUILEGIA VULGARIS; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HOPS; POTASSIUM PHOSPHATE, DIBASIC; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; ZINC 1; 1; 1; 200; 3; 3; 12; 1; 1; 12 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL N 20181231 61096-0002_52113e87-c793-4f3d-b166-5b3689f50dbd 61096-0002 HUMAN OTC DRUG Sprayology Cold and Flu Relief Allium cepa, Antimonium tartaricum, Arnica montana, Baptisia tinctoria, Eupatorium perfoliatum, Gelsemium sempervirens, Kali bichromicum, Lachesis mutus, Mercurius iodatus ruber, Sticta pulmonaria, Sulphur iodatum, Urtica urens LIQUID ORAL 20131106 UNAPPROVED HOMEOPATHIC Eight and Company ONION; ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MERCURIC IODIDE; LOBARIA PULMONARIA; SULFUR IODIDE; URTICA URENS 30; 200; 3; 3; 200; 200; 200; 200; 200; 200; 200; 200 [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL N 20181231 61096-0003_221960b7-aff1-4d50-a7ac-dc31fe816d83 61096-0003 HUMAN OTC DRUG Sprayology AllergEase Allium cepa, apis mellifica, Aralia racemosa, Arundo mauritanica, Baptisia tinctoria, Echinacea, Euphrasia officinalis, gelsemium sempervirens, Histaminum hydrochloricum, Lycopodium clavatum, Rhus toxicodendron, Sabadilla, Sanguinaria canadensis, Urtica urens LIQUID ORAL 20140121 UNAPPROVED HOMEOPATHIC Eight and Company ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; ARUNDO PLINIANA ROOT; BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; HISTAMINE DIHYDROCHLORIDE; LYCOPODIUM CLAVATUM SPORE; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; SANGUINARIA CANADENSIS ROOT; URTICA URENS 6; 3; 6; 30; 3; 4; 6; 200; 12; 6; 200; 6; 200; 200 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL N 20181231 61096-0004_a47c1990-12ac-49c8-a955-95beef48417d 61096-0004 HUMAN OTC DRUG Sprayology Diet Power Apis mellifica, Bolda, Fucus vesiculosus, Galium aparine, Gambogia, Hamamelis virginiana, Hepar suis, Histaminum hydrochloricum, Pancreas suis, Thuja occidentalis LIQUID ORAL 20131230 UNAPPROVED HOMEOPATHIC Eight and Company APIS MELLIFERA; PEUMUS BOLDUS LEAF; FUCUS VESICULOSUS; GALIUM APARINE; GAMBOGE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; HISTAMINE DIHYDROCHLORIDE; SUS SCROFA PANCREAS; THUJA OCCIDENTALIS LEAFY TWIG 6; 3; 3; 3; 3; 3; 12; 200; 12; 6 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL N 20181231 61096-0005_62e34ec8-5f08-4156-845e-71ba1fa47c20 61096-0005 HUMAN OTC DRUG Sprayology DigestivEase Arsenicum album, Calcarea sulphurica, Carbo animalis, Carbo vegetabilis, Cinchona officinalis, Hydrastis canadensis, Nox vomica, Ornithogalum, Pyrogenium, Silicea LIQUID ORAL 20140317 UNAPPROVED HOMEOPATHIC Eight and Company ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; CARBO ANIMALIS; ACTIVATED CHARCOAL; CINCHONA OFFICINALIS BARK; GOLDENSEAL; STRYCHNOS NUX-VOMICA SEED; ORNITHOGALUM UMBELLATUM; RANCID BEEF; SILICON DIOXIDE 200; 200; 12; 12; 200; 12; 200; 12; 200; 12 [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL N 20181231 61096-0006_c99bab8a-7c6b-4c0d-b4e9-3c771ebc87c8 61096-0006 HUMAN OTC DRUG Sprayology Stress Relief Agnus castus, Avena sativa, Cinchona officinalis, Humulus lupulus, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Valeriana officinalis LIQUID ORAL 20140226 UNAPPROVED HOMEOPATHIC Eight and Company CHASTE TREE; AVENA SATIVA FLOWERING TOP; CINCHONA OFFICINALIS BARK; HOPS; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 6; 1; 6; 2; 200; 200; 3; 3 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL N 20181231 61096-0007_85d089f6-fa7d-472b-869f-bed96fae7be7 61096-0007 HUMAN OTC DRUG Sprayology TravelEase Apis mellifica, Carbo vegetabilis, Carduus marianus, Cocculus indicus, Ignatia amara, Nux vomica, Passiflora incarnata, Tabacum LIQUID ORAL 20140122 UNAPPROVED HOMEOPATHIC Eight and Company APIS MELLIFERA; ACTIVATED CHARCOAL; SILYBUM MARIANUM SEED; ANAMIRTA COCCULUS SEED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; TOBACCO LEAF 200; 200; 3; 30; 200; 30; 1; 6 [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL N 20181231 61096-0012_3c425417-9d49-4110-904c-42f6ab0ee1ba 61096-0012 HUMAN OTC DRUG Sprayology Bone Builder Alfalfa, Arnica montana, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Cartilago suis, Hydrofluoricum acidum, Symphytum officinale LIQUID ORAL 20140311 UNAPPROVED HOMEOPATHIC Eight and Company ALFALFA; ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA CARTILAGE; HYDROFLUORIC ACID; COMFREY ROOT 1; 3; 200; 30; 30; 6; 30; 30 [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL N 20181231 61096-0014_b5eafcf7-a376-4cf4-af7f-5369247471b8 61096-0014 HUMAN OTC DRUG Sprayology MenoPower Arnica montana, Glonoinum, Lachesis mutus, Oophorinum, Salvia officinalis, Sanguinaria canadensis, Sepia LIQUID ORAL 20140310 UNAPPROVED HOMEOPATHIC Eight and Company ARNICA MONTANA; NITROGLYCERIN; LACHESIS MUTA VENOM; SUS SCROFA OVARY; SAGE; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE 200; 200; 200; 30; 1; 200; 200 [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL N 20181231 61096-0017_3fa483ae-e9c9-4b76-bc88-722dd1ddf3ce 61096-0017 HUMAN OTC DRUG Sprayology Body Skin Tonic Arsenicum album, Graphites, Mezereum, Radium bromatum, Rhus toxicodendron, Sulphur, Urtica urens LIQUID ORAL 20140205 UNAPPROVED HOMEOPATHIC Eight and Company ARSENIC TRIOXIDE; GRAPHITE; DAPHNE MEZEREUM BARK; RADIUM BROMIDE; TOXICODENDRON PUBESCENS LEAF; SULFUR; URTICA URENS 30; 30; 30; 30; 200; 6; 200 [hp_C]/41mL; [hp_C]/41mL; [arb'U]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL N 20181231 61096-0022_6fac6ada-ba1b-437e-b3ad-5f17f64ff56d 61096-0022 HUMAN OTC DRUG Sprayology Hair and Nail Tonic Avena sativa, DNA, Elaeis guineensis, Glandula suprarenalis suis, Hamamelis virginiana, Hepar suis, Kali sulphuricum, Natrum muriaticum, Nicotinamidum, Phosphoricum acidum, Pituitarum posterium, Riboflavinum, Thiaminum hydrochloricum, Thuja occidentalis, Thyroidinum, Urtica urens LIQUID ORAL 20131108 UNAPPROVED HOMEOPATHIC Eight and Company AVENA SATIVA FLOWERING TOP; HERRING SPERM DNA; ELAEIS GUINEENSIS FRUIT; SUS SCROFA ADRENAL GLAND; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; POTASSIUM SULFATE; SODIUM CHLORIDE; NIACINAMIDE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; URTICA URENS 3; 12; 10; 30; 3; 6; 30; 200; 6; 3; 8; 6; 6; 200; 30; 3 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL N 20181231 61096-0023_33f9f1ef-5cca-49fb-8f40-5080e956866e 61096-0023 HUMAN OTC DRUG Sprayology Life Detoxer Carduus marianus, Hepar suis, Mercurius solubilis, Mucosa nasalis suis, Plumbum metallicum LIQUID ORAL 20140225 UNAPPROVED HOMEOPATHIC Eight and Company MILK THISTLE; PORK LIVER; MERCURIUS SOLUBILIS; SUS SCROFA NASAL MUCOSA; LEAD 1; 6; 200; 6; 200 [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL N 20181231 61096-0024_24086923-c1e3-4364-9f3d-6a79da6ee72d 61096-0024 HUMAN OTC DRUG Sprayology Snore Soother Antimonium tartaricum, Carbo vegetabilis, Mercurius corrosivus, Mucosa nasalis suis, Quebracho, Sticta pulmonaria, Teucrium marum LIQUID ORAL 20140318 UNAPPROVED HOMEOPATHIC Eight and Company ANTIMONY POTASSIUM TARTRATE; ACTIVATED CHARCOAL; MERCURIC CHLORIDE; SUS SCROFA NASAL MUCOSA; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; TEUCRIUM MARUM 200; 12; 200; 6; 3; 200; 3 [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL N 20181231 61096-0027_745b8751-8d81-4c88-a83d-5665f1e27826 61096-0027 HUMAN OTC DRUG Sprayology Acne Tonic Anthracinum, Antimonium crudum, Apis mellifica, Carbo animalis, Hamamelis virginiana, Hepar suis, Hydrocotyle asiatica, Kali bromatum, Mercurius corrosivus, Natrum sulphuratum, Pyrogenium, Radium bromatum, Sanguinaria canadensis, Sulphur iodatum, Thuja occidentalis, Urtica urens LIQUID ORAL 20140225 UNAPPROVED HOMEOPATHIC Eight and Company BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ANTIMONY TRISULFIDE; APIS MELLIFERA; CARBO ANIMALIS; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; CENTELLA ASIATICA; POTASSIUM BROMIDE; MERCURIC CHLORIDE; SODIUM SULFIDE NONAHYDRATE; RANCID BEEF; RADIUM BROMIDE; SANGUINARIA CANADENSIS ROOT; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 200; 30; 4; 12; 3; 6; 30; 30; 200; 200; 30; 200; 3; 200; 200; 3 [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL N 20181231 61096-0030_762a5374-e794-4b74-b7e1-40e1b33dcc44 61096-0030 HUMAN OTC DRUG Sprayology Party Relief Arsenicum album, Avena sativa, Bryonia, Capsicum annuum, Carbo animalis, Carduus marianus, Chelidonium majus, Hepar suis, Kali iodatum, Lapis albus, Radium bromatum, Taraxacum officinale, Thuja occidentalis LIQUID ORAL 20140321 UNAPPROVED HOMEOPATHIC Eight and Company ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BRYONIA ALBA ROOT; CAPSICUM; CARBO ANIMALIS; MILK THISTLE; CHELIDONIUM MAJUS; PORK LIVER; POTASSIUM IODIDE; CALCIUM HEXAFLUOROSILICATE; RADIUM BROMIDE; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG 200; 1; 200; 6; 200; 1; 200; 6; 200; 200; 200; 1; 200 [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL N 20181231 61096-0031_7e464b9c-8104-4191-bb09-488104e343eb 61096-0031 HUMAN OTC DRUG Sprayology PMS Support Apis mellifica, Chamomilla, Cimicifuga racemosa, Cuprum metallicum, Ignatia amara, Kali iodatum, Magnesia phosphorica, Oophorinum, Platinum metallicum, Sepia, Thuja occidentalis LIQUID ORAL 20140310 UNAPPROVED HOMEOPATHIC Eight and Company APIS MELLIFERA; MATRICARIA RECUTITA; BLACK COHOSH; COPPER; STRYCHNOS IGNATII SEED; POTASSIUM IODIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SUS SCROFA OVARY; PLATINUM; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 200; 6; 6; 12; 6; 200; 9; 30; 12; 9; 200 [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL N 20181231 61096-0032_cb95da03-c8da-49ae-8bec-167b47a75aa4 61096-0032 HUMAN OTC DRUG Sprayology Arnica Power 3 Arnica montana LIQUID ORAL 20140122 UNAPPROVED HOMEOPATHIC Eight and Company ARNICA MONTANA 6 [hp_X]/41mL N 20181231 61096-0033_ec02a9a8-afb5-4f6d-83dc-f0080cf018fb 61096-0033 HUMAN OTC DRUG Sprayology Brain Power Arnica montana, Baryta carbonica, Calcarea phosphorica, Ginkgo biloba, Hamamelis virginiana, Millefolium, Phosphoricum acidum LIQUID ORAL 20131105 UNAPPROVED HOMEOPATHIC Eight and Company ARNICA MONTANA; BARIUM CARBONATE; TRIBASIC CALCIUM PHOSPHATE; GINKGO; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACHILLEA MILLEFOLIUM; PHOSPHORIC ACID 3; 30; 30; 6; 3; 3; 30 [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL N 20181231 61096-0034_5837348e-c77c-4751-8198-54aa86549a93 61096-0034 HUMAN OTC DRUG Sprayology Woman Power Agnus castus, Aralia quinquefolia, Arnica montana, Damiana, Lactuca virosa, Natrum muriaticum, Onosmodium virginianum, Oophorinum, Phosphoricum acidum, Pituitarum posterium, Salix nigra, Sepia, Thuja occidentalis LIQUID ORAL 20140205 UNAPPROVED HOMEOPATHIC Eight and Company CHASTE TREE; AMERICAN GINSENG; ARNICA MONTANA; TURNERA DIFFUSA LEAFY TWIG; LACTUCA VIROSA; SODIUM CHLORIDE; ONOSMODIUM VIRGINIANUM WHOLE; SUS SCROFA OVARY; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SALIX NIGRA BARK; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 3; 2; 3; 2; 3; 30; 30; 30; 200; 12; 3; 30; 30 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL N 20181231 61096-0035_862afdae-3a04-4561-a6ca-f9ec584b99e5 61096-0035 HUMAN OTC DRUG Sprayology Rejuvenation Plus Aralia quinquefolia, Arnica montana, Avena sativa, Baryta carbonica, Carduus marianus, DNA, Hepar suis, Medulla ossis suis, Pancreas suis, Phosphoricum acidum, Pituitarum posterium, Thuja occidentalis LIQUID ORAL 20140317 UNAPPROVED HOMEOPATHIC Eight and Company AMERICAN GINSENG; ARNICA MONTANA; AVENA SATIVA FLOWERING TOP; BARIUM CARBONATE; MILK THISTLE; HERRING SPERM DNA; PORK LIVER; SUS SCROFA BONE MARROW; SUS SCROFA PANCREAS; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 6; 30; 3; 12; 6; 6; 6; 3; 30; 30 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL N 20181231 61096-0038_22ba8561-5789-4192-9507-eba24073d67a 61096-0038 HUMAN OTC DRUG Sprayology ImmunoBooster Arsenicum album, Baptisia tinctoria, Echinacea, Medulla ossis suis, Mercurius corrosivus, Sulphur iodatum, thuja occidentalis LIQUID ORAL 20140317 UNAPPROVED HOMEOPATHIC Eight and Company ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ECHINACEA, UNSPECIFIED; SUS SCROFA BONE MARROW; MERCURIC CHLORIDE; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG 200; 4; 4; 6; 200; 200; 200 [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL N 20181231 61096-0039_c70e464b-8a82-4bd3-8448-d675979ff9d7 61096-0039 HUMAN OTC DRUG Sprayology Body Balance Aralia quinquefolia, Arnica montana, Carduus marianus, Elaeis guineensis, Glandula suprarenalis suis, Natrum muriaticum, Phosphoricum acidum, Thuja occidentalis LIQUID ORAL 20140226 UNAPPROVED HOMEOPATHIC Eight and Company AMERICAN GINSENG; ARNICA MONTANA; MILK THISTLE; ELAEIS GUINEENSIS FRUIT; SUS SCROFA ADRENAL GLAND; SODIUM CHLORIDE; PHOSPHORIC ACID; THUJA OCCIDENTALIS LEAFY TWIG 3; 3; 3; 10; 12; 30; 200; 200 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL N 20181231 61096-1001_9aa92659-233c-4bc0-a2ef-d246470365ec 61096-1001 HUMAN OTC DRUG Sprayology SleepEase Aquilegia vulgaris, Avena sativa, Chamomilla, Coffea cruda, Cypripedium pubescens, Humulus lupulus, Kali phosphoricum, Passiflora incarnata, Valeriana officinalis, Zincum metallicum LIQUID ORAL 20160728 UNAPPROVED HOMEOPATHIC Eight and Company AQUILEGIA VULGARIS; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HOPS; POTASSIUM PHOSPHATE, DIBASIC; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; ZINC 2; 2; 2; 200; 3; 3; 12; 2; 2; 12 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL N 20181231 61096-1007_b7f7c78d-6136-459c-9aee-5c854fd6c553 61096-1007 HUMAN OTC DRUG Sprayology TravelEase Apis mellifica, Carbo vegetabilis, Carduus marianus, Cocculus indicus, Ignatia amara, Nux vomica, Passiflora incarnata, Tabacum LIQUID ORAL 20160726 UNAPPROVED HOMEOPATHIC Eight and Company APIS MELLIFERA; ACTIVATED CHARCOAL; MILK THISTLE; ANAMIRTA COCCULUS SEED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; TOBACCO LEAF 200; 200; 3; 30; 200; 30; 2; 6 [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL N 20181231 61096-1012_50472756-da72-4753-ba66-33ad0f7fa899 61096-1012 HUMAN OTC DRUG Sprayology Bone Builder Alfalfa, Arnica montana, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Cartilago suis, Hydrofluoricum acidum, Symphytum officinale LIQUID ORAL 20160726 UNAPPROVED HOMEOPATHIC Eight and Company ALFALFA; ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA CARTILAGE; HYDROFLUORIC ACID; COMFREY ROOT 2; 3; 200; 30; 30; 6; 30; 30 [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL N 20181231 61096-1014_a4cc117a-d62c-4047-b5b1-910dca49ca94 61096-1014 HUMAN OTC DRUG Sprayology MenoPower Arnica montana, Glonoinum, Lachesis mutus, Oophorinum, Salvia officinalis, Sanguinaria canadensis, Sepia LIQUID ORAL 20160729 UNAPPROVED HOMEOPATHIC Eight and Company ARNICA MONTANA; NITROGLYCERIN; LACHESIS MUTA VENOM; SUS SCROFA OVARY; SAGE; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE 200; 200; 200; 30; 2; 200; 200 [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL N 20181231 61096-1023_031b2ce4-b005-4ad7-8644-97c253b0860e 61096-1023 HUMAN OTC DRUG Sprayology Life Detoxer Carduus marianus, Hepar suis, Mercurius solubilis, Mucosa nasalis suis, Plumbum metallicum LIQUID ORAL 20160726 UNAPPROVED HOMEOPATHIC Eight and Company MILK THISTLE; PORK LIVER; MERCURIUS SOLUBILIS; SUS SCROFA NASAL MUCOSA; LEAD 2; 6; 200; 6; 200 [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_C]/41mL N 20181231 61096-1025_1db5d427-edfa-4c8a-a15b-3b0bc58eba70 61096-1025 HUMAN OTC DRUG Sprayology Man Power Agnus castus, Aralia quinquefolia, Argentum nitricum, Arnica montana, Caladium seginum, Damiana, Lactuca virosa, Nuphar luteum, Orchitinum, Phosphoricum acidum LIQUID ORAL 20150729 UNAPPROVED HOMEOPATHIC Eight and Company CHASTE TREE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; DIEFFENBACHIA SEGUINE; TURNERA DIFFUSA LEAFY TWIG; LACTUCA VIROSA; NUPHAR LUTEUM ROOT; SUS SCROFA TESTICLE; PHOSPHORIC ACID 3; 2; 30; 3; 6; 2; 3; 2; 6; 200 [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL N 20181231 61096-1034_144ed6ac-d2da-4731-a54a-7d90c7047f3e 61096-1034 HUMAN OTC DRUG Sprayology Woman Power Agnus castus, Aralia quinquefolia, Arnica montana, Damiana, Lactuca virosa, Natrum muriaticum, Onosmodium virginianum, Oophorinum, Phosphoricum acidum, Pituitarum posterium, Salix nigra, Sepia, Thuja occidentalis LIQUID ORAL 20160729 UNAPPROVED HOMEOPATHIC Eight and Company CHASTE TREE; AMERICAN GINSENG; ARNICA MONTANA; TURNERA DIFFUSA LEAFY TWIG; LACTUCA VIROSA; SODIUM CHLORIDE; ONOSMODIUM VIRGINIANUM WHOLE; SUS SCROFA OVARY; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SALIX NIGRA BARK; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG 3; 2; 3; 2; 3; 30; 30; 30; 200; 12; 3; 30; 30 [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_C]/41mL; [hp_C]/41mL N 20181231 61098-010_c69762d1-30d5-4af4-86d8-5927192bedcc 61098-010 HUMAN OTC DRUG REVERDIR PTD Black Diamond Mask Allantoin PATCH TOPICAL 20140601 OTC MONOGRAPH FINAL part347 ADBIOTECH CO., LTD. ALLANTOIN .16 g/32g N 20181231 61098-020_cb330fdb-c3a6-4669-9e20-44224dabb24d 61098-020 HUMAN OTC DRUG REVERDIR PTD ENERGY SERUM Allantoin CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 ADBIOTECH CO., LTD. ALLANTOIN .15 mg/30mL N 20181231 61098-030_b52e2e8b-a67a-4479-9b20-4c6a4e292499 61098-030 HUMAN OTC DRUG REVERDIR PTD RENEW ESSENCE Allantoin CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 ADBIOTECH CO., LTD. ALLANTOIN .15 mg/30mL N 20181231 61098-040_c19af9c6-7110-4c8d-95d6-f961c02ecfd6 61098-040 HUMAN OTC DRUG REVERDIR PTD REACTING Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 ADBIOTECH CO., LTD. DIMETHICONE .6 g/30g N 20181231 61098-050_04a591b0-5a64-4e34-9d49-45b5a8f4b8b3 61098-050 HUMAN OTC DRUG REVERDIR AMPOULE 7mL Allantoin SOLUTION TOPICAL 20141001 OTC MONOGRAPH FINAL part347 ADBIOTECH CO., LTD. ALLANTOIN .175 mg/51 N 20181231 61112-001_6d0147c3-27c1-4737-8a76-edd4c8f01ca6 61112-001 HUMAN PRESCRIPTION DRUG Omtryg omega-3-acid ethyl esters CAPSULE ORAL 20160701 NDA NDA204977 Trygg Pharma Inc OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] E 20171231 61119-1001_5566c682-871f-4d17-8b96-42a83da99334 61119-1001 HUMAN OTC DRUG Doctor-Clean SODIUM FLUORIDE MOUTHWASH DENTAL 20131116 OTC MONOGRAPH FINAL part355 Bowon Dental Co., Ltd SODIUM FLUORIDE .02 g/100mL E 20171231 61126-003_fd135112-4330-42bd-ac2e-d3cd6f96325d 61126-003 HUMAN PRESCRIPTION DRUG Platinol cisplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120113 NDA NDA018057 Corden Pharma Latina S.p.A. CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 61126-004_d3e05034-cd9e-4dac-8c71-21f27772bf5e 61126-004 HUMAN PRESCRIPTION DRUG Platinol-AQ cisplatin INJECTION, SOLUTION INTRAVENOUS 20120113 NDA NDA018057 Corden Pharma Latina S.p.A. CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 61128-001_f559f2dd-4da9-4d51-a3c5-303763225d14 61128-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20071201 NDA NDA205712 Super Gas, Inc. OXYGEN 992 L/1000L N 20181231 61128-002_fab16ddb-4a86-48e4-b7e5-2237571d6156 61128-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20071201 NDA NDA205713 Super Gas, Inc. NITROGEN 992 L/1000L N 20181231 61139-421_d36346f0-be43-4775-a538-8692d01aa6a8 61139-421 HUMAN OTC DRUG Highmark Professional Gold and Clean Antimicrobial Ltn Sp Chloroxylenol LIQUID TOPICAL 20131122 OTC MONOGRAPH NOT FINAL part333E Office Max, Inc. CHLOROXYLENOL .003 mg/mL E 20171231 61139-422_59ffa252-e4ed-4b56-92ba-417e0c26f2a6 61139-422 HUMAN OTC DRUG HighMark Professional Pink Antimicrobial Ltn Sp Chloroxylenol LIQUID TOPICAL 20131122 OTC MONOGRAPH NOT FINAL part333E Office Max, Inc. CHLOROXYLENOL .003 mg/mL E 20171231 61139-511_179b0425-5298-4875-a323-c818b85600b8 61139-511 HUMAN OTC DRUG Highmark Professional Antibacterial Foam Handwash Chloroxylenol LIQUID TOPICAL 20131122 OTC MONOGRAPH NOT FINAL part333E Office Max, Inc. CHLOROXYLENOL .003 mg/mL E 20171231 61139-512_959db8ad-9d00-4b8d-a4a9-702164db866c 61139-512 HUMAN OTC DRUG Highmark Professional Luxury Foam Antibacterial Handwash Chloroxylenol LIQUID TOPICAL 20131122 OTC MONOGRAPH NOT FINAL part333E Office Max, Inc. CHLOROXYLENOL .003 mg/mL E 20171231 61139-513_04f4d545-8851-4d48-a9c4-c5b065482e49 61139-513 HUMAN OTC DRUG Highmark Professional Premium Foam Antibacterial Handwash Chloroxylenol LIQUID TOPICAL 20131122 OTC MONOGRAPH NOT FINAL part333E Office Max, Inc. CHLOROXYLENOL .003 mg/mL E 20171231 61145-101_48b7b61a-66e7-49ce-baa8-06ad0105ea24 61145-101 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20170927 ANDA ANDA075185 RePharm Pharmaceuticals DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61145-102_48b7b61a-66e7-49ce-baa8-06ad0105ea24 61145-102 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20170927 ANDA ANDA075185 RePharm Pharmaceuticals DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61152-195_fd5e17a0-fc5c-402e-8087-6f22c0d2aad2 61152-195 HUMAN OTC DRUG SnoreStop FastTabs Maximum Strength Belladonna, Ephedra vulgaris, Histaminum hydrochloricum, Hydrastis canadensis, Kali bichromicum, Nux vomica, Teucrium marum TABLET, CHEWABLE ORAL 20120917 UNAPPROVED HOMEOPATHIC Green Pharmaceuticals ATROPA BELLADONNA; EPHEDRA DISTACHYA FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM 6; 6; 12; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 61164-2001_0dd37bb9-31fe-293d-e054-00144ff88e88 61164-2001 HUMAN OTC DRUG S Balloon Slim Body Line HYDROGENATED SOYBEAN LIQUID TOPICAL 20140911 OTC MONOGRAPH FINAL part357C Barona Co., Ltd HYDROGENATED SOYBEAN OIL 2 g/100mL E 20171231 61164-5001_cd88469a-0cd8-4f3a-b8ec-0930423809c3 61164-5001 HUMAN OTC DRUG MONANE CURCUMA AROMATICA ROOT LIQUID TOPICAL 20150204 UNAPPROVED DRUG OTHER Barona Co., Ltd CURCUMA AROMATICA ROOT OIL 15 g/100mL E 20171231 61164-6001_2e36968c-4b47-4413-b204-e6a3862c8cb9 61164-6001 HUMAN OTC DRUG S.COLINE HYDROGENATED SOYBEAN LIQUID TOPICAL 20150102 OTC MONOGRAPH FINAL part357C Barona Co., Ltd HYDROGENATED SOYBEAN OIL 2 g/100mL E 20171231 61164-7001_55254944-65b4-41dc-a13e-20114772445f 61164-7001 HUMAN OTC DRUG Luxuriant hair for solutions peppermint oil LIQUID TOPICAL 20160201 UNAPPROVED DRUG OTHER Barona Co., Ltd PEPPERMINT OIL .1 g/100g E 20171231 61165-1001_cf307a34-7f79-4b34-b852-cab4b8058dc2 61165-1001 HUMAN OTC DRUG Lubas SILICON DIOXIDE PASTE, DENTIFRICE DENTAL 20131123 UNAPPROVED DRUG OTHER LUBASBIO CO., LTD SILICON DIOXIDE 17 g/100g E 20171231 61165-2001_b4345f51-318f-4e21-bf36-8b7f72d1d981 61165-2001 HUMAN OTC DRUG ATO-K PANAX GINSENG ROOT OIL SOAP TOPICAL 20131123 UNAPPROVED DRUG OTHER LUBASBIO CO., LTD PANAX GINSENG ROOT OIL .5 g/100g E 20171231 61168-101_3e08dbba-d864-4542-8249-45933a6d37cd 61168-101 HUMAN PRESCRIPTION DRUG KYBELLA Deoxycholic Acid INJECTION, SOLUTION SUBCUTANEOUS 20150608 NDA NDA206333 Kythera Biopharmaceuticals Inc. DEOXYCHOLIC ACID 20 mg/2mL Cytolytic Agent [EPC],Decreased Cell Membrane Integrity [PE] N 20191231 61180-111_a7612aa2-8d0a-4991-a867-6f3cbdba0a81 61180-111 HUMAN OTC DRUG Antibacterial Hand Sanitizer with Vitamine E ALCOHOL SOLUTION TOPICAL 20160313 OTC MONOGRAPH NOT FINAL part333E CJ Pharmaceuticals, LLC ALCOHOL .7 mL/mL E 20171231 61197-000_8ae7f906-bb1a-412f-abf3-57a5879c309f 61197-000 HUMAN OTC DRUG Pacifica CC broad spectrum SPF 17 LIGHT ZINC OXIDE CREAM TOPICAL 20131121 OTC MONOGRAPH NOT FINAL part352 Pacifica Inc. ZINC OXIDE 114 mg/mL E 20171231 61197-001_1ffd8362-15e8-40de-bdbb-bf6fcf61ac98 61197-001 HUMAN OTC DRUG Pacifica CC broad spectrum SPF 17 MEDIUM ZINC OXIDE CREAM TOPICAL 20131121 OTC MONOGRAPH NOT FINAL part352 Pacifica Inc. ZINC OXIDE 114 mg/mL E 20171231 61210-001_d007c379-67a3-4b2c-ad9b-433f2919d16d 61210-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19940101 NDA NDA205849 Pekin Prohealth Inc. OXYGEN 990 mL/L N 20181231 61220-001_bda2c93f-6b1f-4827-b6c6-e7572142c1f2 61220-001 HUMAN OTC DRUG Hydraday Octocrylene and Avobenzone CREAM TOPICAL 20131120 OTC MONOGRAPH NOT FINAL part352 PF Invest Company OCTOCRYLENE; AVOBENZONE 2.5; 1.5 mg/50mg; mg/50mg E 20171231 61220-002_2dcb6e69-ffbe-4af1-e054-00144ff88e88 61220-002 HUMAN OTC DRUG Day Moisturizer SPF 15 Octocrylene Butyl Methoxydibenzoyl Methane (Avobenzone) CREAM TOPICAL 20160226 OTC MONOGRAPH FINAL part352 PF Invest Company OCTOCRYLENE; AVOBENZONE 2.5; 1.5 mg/100mg; mg/100mg E 20171231 61220-002_2e0769a3-6eb9-0eef-e054-00144ff88e88 61220-002 HUMAN OTC DRUG Day Moisturizer SPF 15 Octocrylene Butyl Methoxydibenzoyl Methane (Avobenzone) CREAM TOPICAL 20160311 OTC MONOGRAPH FINAL part352 PF Invest Company OCTOCRYLENE; AVOBENZONE 2.5; 1.5 mg/100mg; mg/100mg E 20171231 61221-010_5224cd16-ccb8-4139-ad00-c596b582eed9 61221-010 HUMAN OTC DRUG NAAMAN Allantoin CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 LEADER GREEN CO., LTD. ALLANTOIN .25 mg/50mL E 20171231 61221-020_5a5626dc-ff5a-453b-a928-c199cb0aee4b 61221-020 HUMAN OTC DRUG VASHTI Allantoin CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 LEADER GREEN CO., LTD. ALLANTOIN .25 mg/50mL E 20171231 61223-101_204c8d4b-47d2-43c2-bc4c-3781893ba812 61223-101 HUMAN OTC DRUG COLD SORE SUPPORT ALLANTOIN, AVOBENZONE, MENTHOL, OCTINOXATE AND ZINC OXIDE LIPSTICK TOPICAL 20131201 OTC MONOGRAPH FINAL part347 MiraCell Inc ALLANTOIN; AVOBENZONE; MENTHOL; OCTINOXATE; ZINC OXIDE .75; 2.5; 1; 5.5; 3.5 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61238-1125_ff852f31-41e7-4569-8849-29fa82215edb 61238-1125 HUMAN OTC DRUG Miss Spa Hand Sanitiser GEL TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part333E Oriental Home Sense Co., Ltd. ALCOHOL 554 mL/554mL E 20171231 61245-084_4a1402fa-88af-5e74-e054-00144ff8d46c 61245-084 HUMAN OTC DRUG Direct Safety Ibuprofen Ibuprofen TABLET, COATED ORAL 20141117 ANDA ANDA079174 Conney Safety Products, LLC IBUPROFEN 200 mg/1 N 20181231 61245-085_4a150730-2b8f-6492-e054-00144ff88e88 61245-085 HUMAN OTC DRUG Direct Safety Ibuprofen Ibuprofen TABLET, COATED ORAL 20160201 ANDA ANDA075010 Conney Safety Products, LLC IBUPROFEN 200 mg/1 N 20181231 61245-116_4a139335-636f-4c99-e054-00144ff8d46c 61245-116 HUMAN OTC DRUG Direct Safety Aspirin Aspirin TABLET, FILM COATED ORAL 20130503 OTC MONOGRAPH FINAL part343 Conney Safety Products, LLC ASPIRIN 325 mg/1 N 20181231 61245-145_4a531604-33c1-69f6-e054-00144ff88e88 61245-145 HUMAN OTC DRUG Direct Safety Aspirin Free Acetaminophen TABLET, FILM COATED ORAL 20130531 OTC MONOGRAPH NOT FINAL part343 Conney Safety Products, LLC ACETAMINOPHEN 325 mg/1 N 20181231 61245-146_4a531604-33c1-69f6-e054-00144ff88e88 61245-146 HUMAN OTC DRUG Direct Safety Aspirin Free Acetaminophen TABLET, FILM COATED ORAL 20130531 OTC MONOGRAPH NOT FINAL part343 Conney Safety Products, LLC ACETAMINOPHEN 325 mg/1 N 20181231 61245-175_4a645652-ad72-3811-e054-00144ff8d46c 61245-175 HUMAN OTC DRUG Direct Safety Extra Strength Aspirin Free Acetaminophen TABLET, FILM COATED ORAL 20130531 OTC MONOGRAPH NOT FINAL part343 Conney Safety Products, LLC ACETAMINOPHEN 500 mg/1 N 20181231 61245-176_4a645652-ad72-3811-e054-00144ff8d46c 61245-176 HUMAN OTC DRUG Direct Safety Extra Strength Aspirin Free Acetaminophen TABLET, FILM COATED ORAL 20130531 OTC MONOGRAPH NOT FINAL part343 Conney Safety Products, LLC ACETAMINOPHEN 500 mg/1 N 20181231 61252-3005_45a08ce9-6958-4b03-bc7f-7a17b9fe0127 61252-3005 HUMAN PRESCRIPTION DRUG Nicotine UN1654 Nicotine UN1654 LIQUID ORAL 19970711 UNAPPROVED DRUG OTHER Nicobrand LTD NICOTINE 1 L/L Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] N 20181231 61252-3006_a3368095-95ba-491a-86d5-b1a65c788006 61252-3006 HUMAN PRESCRIPTION DRUG nicotine tartrate nicotine tartrate POWDER ORAL 19970711 UNAPPROVED DRUG OTHER Nicobrand LTD NICOTINE BITARTRATE ANHYDROUS 1 kg/kg Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] N 20181231 61254-1001_d74711ef-a43f-4e68-88e2-2e0688250289 61254-1001 HUMAN OTC DRUG HUM GLYCERIN CREAM TOPICAL 20131210 OTC MONOGRAPH FINAL part347 Happy Sonic Global Co., Ltd. GLYCERIN .1 g/100mL E 20171231 61254-2001_cde18d5d-2539-415c-8832-021bb4390227 61254-2001 HUMAN OTC DRUG Coral S GLYCERIN SOAP TOPICAL 20140302 OTC MONOGRAPH FINAL part347 Happy Sonic Global Co., Ltd. GLYCERIN .1 g/100g E 20171231 61254-3001_c795fd69-e1ea-4163-8b40-4a1524654091 61254-3001 HUMAN OTC DRUG Hum CC GLYCERIN CREAM TOPICAL 20140302 OTC MONOGRAPH FINAL part347 Happy Sonic Global Co., Ltd. GLYCERIN .1 g/100g E 20171231 61254-4001_ed5ea553-58f6-4c5e-99ab-5918dcceeb25 61254-4001 HUMAN OTC DRUG Hum Body Liner GLYCERIN CREAM TOPICAL 20140302 OTC MONOGRAPH FINAL part347 Happy Sonic Global Co., Ltd. GLYCERIN .1 g/100g E 20171231 61269-210_8da243b2-fa62-4e6f-a064-12d15e0eda29 61269-210 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20140505 NDA NDA021612 H2-Pharma, LLC FENOFIBRATE 50 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 61269-212_8da243b2-fa62-4e6f-a064-12d15e0eda29 61269-212 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20140505 NDA NDA021612 H2-Pharma, LLC FENOFIBRATE 150 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 61269-460_631dab48-74a0-a0f3-e053-2991aa0a6f61 61269-460 HUMAN PRESCRIPTION DRUG Xenical orlistat CAPSULE ORAL 20101217 NDA NDA020766 H2-Pharma LLC ORLISTAT 120 mg/1 Intestinal Lipase Inhibitor [EPC],Lipase Inhibitors [MoA] N 20191231 61291-011_0f0b6a1c-be77-40b6-b7be-2209f873891a 61291-011 HUMAN OTC DRUG Eugenol Eugenol LIQUID ORAL 20150130 OTC MONOGRAPH NOT FINAL part356 Polysciences, Inc EUGENOL 850 mg/mL N 20181231 61296-000_10cc3c34-8e0e-4bb7-9cb1-a45460f2267c 61296-000 HUMAN OTC DRUG BIOSOLIS Sun Milk UVA Sunscreen Face and Body Broad Spectrum SPF15 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 Pro Vera SA TITANIUM DIOXIDE; ZINC OXIDE 63.4; 48.5 mg/mL; mg/mL N 20181231 61296-001_5530fc13-2a19-4660-b300-0538968d5d3c 61296-001 HUMAN OTC DRUG BIOSOLIS Sun Milk UVA Sunscreen Face and Body Broad Spectrum SPF30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 Pro Vera SA TITANIUM DIOXIDE; ZINC OXIDE 86.6; 63.1 mg/mL; mg/mL N 20181231 61296-002_98401065-7d9b-4eac-ad19-753cd5f3d31d 61296-002 HUMAN OTC DRUG BIOSOLIS Sun Milk UVA Sunscreen Face and Body Broad Spectrum SPF50 KIDS TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 Pro Vera SA TITANIUM DIOXIDE; ZINC OXIDE 168; 97 mg/mL; mg/mL N 20181231 61296-003_6c0817ac-af0e-4420-add9-468bbbb4ca50 61296-003 HUMAN OTC DRUG BIOSOLIS Extreme Fluid UVA Sunscreen Broad Spectrum Face and Neck SPF50 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 Pro Vera SA TITANIUM DIOXIDE; ZINC OXIDE 168; 97 mg/mL; mg/mL N 20181231 61296-004_21c3ef95-444c-44d9-994d-e0ceccbaeac5 61296-004 HUMAN OTC DRUG BIOSOLIS Face UVA Sunscreen Broad Spectrum SPF30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part352 Pro Vera SA TITANIUM DIOXIDE; ZINC OXIDE 90; 67.9 mg/mL; mg/mL N 20181231 61300-0001_381b38b5-bfeb-4c2a-b402-bcaa8a2fb5e6 61300-0001 HUMAN OTC DRUG MAX Abrotanum (Artemisia abrotanum), Anacardium orientale, Baryta muriatica, Calcarea carbonica, Calcarea phosphorica, Fucus vesiculosus, Graphites, Helleborus niger, SPRAY ORAL 20140430 UNAPPROVED HOMEOPATHIC Arize Supplements, LLC ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; FUCUS VESICULOSUS; GRAPHITE; HELLEBORUS NIGER ROOT; SUS SCROFA HYPOTHALAMUS; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; THYMOL; SUS SCROFA THYROID; ONION; PORK LIVER; SUS SCROFA PANCREAS; SUS SCROFA ADRENAL GLAND; MELATONIN; NIACINAMIDE; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SEROTONIN HYDROCHLORIDE; THIAMINE HYDROCHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 61307-213_478d00cb-9fe5-0ac0-e054-00144ff8d46c 61307-213 HUMAN OTC DRUG Indulgence/ProPower Benzalkonium Chloride SOAP TOPICAL 20170130 OTC MONOGRAPH NOT FINAL part333E U S Chemical Corp Wis BENZALKONIUM CHLORIDE 2.5 mg/L N 20181231 61310-100_1c213dd4-6155-4172-9e13-5c84d5cf1c02 61310-100 HUMAN OTC DRUG MoReturn Hair Tonic Panthenol (0.2%), Biotin (0.06%) SPRAY TOPICAL 20131220 UNAPPROVED DRUG OTHER Moreand Co., Ltd. PANTHENOL; BIOTIN .2; .06 g/100mL; g/100mL E 20171231 61310-101_791147fa-c1ee-456c-a814-7f73761baf35 61310-101 HUMAN OTC DRUG MoRreturn Hair Care Panthenol (0.2%), Biotin (0.06%) SHAMPOO TOPICAL 20131220 UNAPPROVED DRUG OTHER Moreand Co., Ltd. PANTHENOL; BIOTIN 1; .3 g/500mL; g/500mL E 20171231 61310-102_30d49f6d-ef47-4bac-ac0e-dc570a7bdccc 61310-102 HUMAN OTC DRUG MoReturn Hair Panthenol, Biotin SHAMPOO TOPICAL 20131220 UNAPPROVED DRUG OTHER Moreand Co., Ltd. PANTHENOL; BIOTIN 1; .3 g/500mL; g/500mL E 20171231 61312-001_6258b68a-7db0-1fe5-e053-2991aa0a9b1e 61312-001 HUMAN OTC DRUG Hand Sanitizing wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20130314 OTC MONOGRAPH NOT FINAL part333A HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. BENZALKONIUM CHLORIDE .13 g/100g N 20191231 61312-002_6258b484-0da3-fb90-e053-2a91aa0a14ae 61312-002 HUMAN OTC DRUG Hand Sanitizing wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20140924 OTC MONOGRAPH NOT FINAL part333A HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. BENZALKONIUM CHLORIDE .13 g/100g N 20191231 61312-003_6258b484-0d95-fb90-e053-2a91aa0a14ae 61312-003 HUMAN OTC DRUG wet wipes SALICYLIC ACID SWAB TOPICAL 20150225 OTC MONOGRAPH FINAL part358B HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. SALICYLIC ACID 2 g/100g N 20191231 61312-004_6258b484-0d87-fb90-e053-2a91aa0a14ae 61312-004 HUMAN OTC DRUG wet wipes SALICYLIC ACID SWAB TOPICAL 20150225 OTC MONOGRAPH FINAL part358B HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. SALICYLIC ACID .5 g/100g N 20191231 61312-005_fa2c98fa-523d-4069-b6dc-2ae8ed6a4bf3 61312-005 HUMAN OTC DRUG wet wipes SALICYLIC ACID SWAB TOPICAL 20150225 OTC MONOGRAPH FINAL part358B HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. SALICYLIC ACID .5 g/100g E 20171231 61312-006_62583244-ebed-71c8-e053-2a91aa0a54eb 61312-006 HUMAN OTC DRUG wet wipes SALICYLIC ACID SWAB TOPICAL 20150225 OTC MONOGRAPH FINAL part358B HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. SALICYLIC ACID 1 g/100g N 20191231 61312-007_621793d7-3fec-5379-e053-2a91aa0a11c8 61312-007 HUMAN OTC DRUG antibacterial hand sanitizer Benzalkonium Chloride GEL TOPICAL 20140227 OTC MONOGRAPH NOT FINAL part333E Hangzhou Guoguang Touring Commodity Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100g N 20191231 61312-008_62175f7d-6bf3-2fb8-e053-2991aa0adb4b 61312-008 HUMAN OTC DRUG HAND SANITIZER ALCOHOL GEL TOPICAL 20130330 OTC MONOGRAPH NOT FINAL part333E Hangzhou Guoguang Touring Commodity Co., Ltd. ALCOHOL 63 mL/100mL N 20191231 61312-009_62583244-ebe3-71c8-e053-2a91aa0a54eb 61312-009 HUMAN OTC DRUG Hand wipes CHLORHEXIDINE GLUCONATE and BENZALKONIUM CHLORIDE SWAB TOPICAL 20170624 OTC MONOGRAPH NOT FINAL part333A HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. CHLORHEXIDINE GLUCONATE; BENZALKONIUM CHLORIDE .5; .08 g/100g; g/100g N 20191231 61312-010_62583244-ebd5-71c8-e053-2a91aa0a54eb 61312-010 HUMAN OTC DRUG PremierPro Flushable Wipes with Dimethicone DIMETHICONE SWAB TOPICAL 20170713 OTC MONOGRAPH FINAL part347 HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. DIMETHICONE 32 mg/g N 20191231 61312-011_6257ef5b-2646-526e-e053-2991aa0a14b9 61312-011 HUMAN OTC DRUG Mousse Non-rinse Hand Sanitizer(Fragrance Free / Grapefruit) BENZALKONIUM CHLORIDE GEL TOPICAL 20161011 OTC MONOGRAPH NOT FINAL part333E Hangzhou Guoguang Touring Commodity Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100g N 20191231 61314-012_1f88e5a7-78c8-4f48-81bd-5fd664cee9c8 61314-012 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION OPHTHALMIC 20040514 ANDA ANDA076231 Falcon Pharmaceuticals, Ltd. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 61314-014_cb1cf616-d6c2-4a76-b4dd-4a64290a3415 61314-014 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION OPHTHALMIC 20080214 ANDA ANDA078031 Sandoz Inc DICLOFENAC SODIUM 1 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61314-015_b2235a46-f526-471e-8a9c-62f943ef6f7b 61314-015 HUMAN PRESCRIPTION DRUG Ofloxacin ofloxacin SOLUTION AURICULAR (OTIC) 20080331 ANDA ANDA078222 Falcon Pharmaceuticals, Ltd. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 61314-016_6ee9f25e-1008-459e-a7f8-9c9ae5552edd 61314-016 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20000605 ANDA ANDA080027 Sandoz Inc. PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] N 20181231 61314-018_d68308ce-8a75-460b-b1a0-50614ae351a2 61314-018 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078721 Sandoz Inc KETOROLAC TROMETHAMINE 4 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 61314-019_a623c18d-fabd-4d97-b2e1-32593ff27c3d 61314-019 HUMAN PRESCRIPTION DRUG DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/ DROPS OPHTHALMIC 20090601 ANDA ANDA078981 Sandoz Inc DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA] N 20181231 61314-030_4f3794e2-0731-4fc7-96e4-f25a80054841 61314-030 HUMAN PRESCRIPTION DRUG Dorzolamide Hydrochloride and Timolol Maleate Dorzolamide Hydrochloride and Timolol Maleate SOLUTION OPHTHALMIC 20100102 ANDA ANDA090604 Sandoz Inc DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 20; 5 mg/mL; mg/mL Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61314-044_2113a07b-d748-4621-9ca1-b22affc96fd8 61314-044 HUMAN PRESCRIPTION DRUG Trifluridine trifluridine SOLUTION OPHTHALMIC 20010514 ANDA ANDA074311 Sandoz Inc TRIFLURIDINE 10 mg/mL Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC],Nucleoside Metabolic Inhibitor [EPC],Nucleic Acid Synthesis Inhibitors [MoA] N 20181231 61314-126_78e04a7a-6076-4439-ab5d-9a4459f85106 61314-126 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA076583 Sandoz Inc KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20191231 61314-143_2d66fa03-f6c8-4eac-9f78-5072ef84e3d3 61314-143 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate Brimonidine Tartrate SOLUTION OPHTHALMIC 20030917 ANDA ANDA076254 Sandoz Inc BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 61314-144_d3bb4638-7801-4dd3-b923-23a7e5bb04ce 61314-144 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate Brimonidine Tartrate SOLUTION OPHTHALMIC 20101002 NDA NDA021764 Sandoz Inc BRIMONIDINE TARTRATE 1.5 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 61314-203_77079a6c-b338-4b76-e098-2527fd5c27f9 61314-203 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride pilocarpine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19960221 NDA AUTHORIZED GENERIC NDA200890 Sandoz Inc. PILOCARPINE HYDROCHLORIDE 10 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 61314-204_77079a6c-b338-4b76-e098-2527fd5c27f9 61314-204 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride pilocarpine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19960221 NDA AUTHORIZED GENERIC NDA200890 Sandoz Inc. PILOCARPINE HYDROCHLORIDE 20 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 61314-206_77079a6c-b338-4b76-e098-2527fd5c27f9 61314-206 HUMAN PRESCRIPTION DRUG Pilocarpine Hydrochloride pilocarpine hydrochloride SOLUTION/ DROPS OPHTHALMIC 19960221 NDA AUTHORIZED GENERIC NDA200890 Sandoz Inc. PILOCARPINE HYDROCHLORIDE 40 mg/mL Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 61314-224_f66511ab-290a-4509-ae67-9fd69d72a80b 61314-224 HUMAN PRESCRIPTION DRUG Timolol GFS timolol maleate SOLUTION, GEL FORMING, EXTENDED RELEASE OPHTHALMIC 19981224 NDA NDA020963 Sandoz Inc TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61314-225_f66511ab-290a-4509-ae67-9fd69d72a80b 61314-225 HUMAN PRESCRIPTION DRUG Timolol GFS timolol maleate SOLUTION, GEL FORMING, EXTENDED RELEASE OPHTHALMIC 19981224 NDA NDA020963 Sandoz Inc TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61314-226_ad41fe51-cf0f-4a30-ba49-c9665f2d208b 61314-226 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 19960115 ANDA ANDA074261 Sandoz Inc TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61314-227_ad41fe51-cf0f-4a30-ba49-c9665f2d208b 61314-227 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 19960115 ANDA ANDA074262 Sandoz Inc TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61314-229_6de7ad08-8e96-4853-a617-a6d896fa7dba 61314-229 HUMAN PRESCRIPTION DRUG Levobunolol Hydrochloride Levobunolol Hydrochloride SOLUTION OPHTHALMIC 19970130 ANDA ANDA074850 Sandoz Inc LEVOBUNOLOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61314-237_d0c5f8f0-bcea-497c-bbad-0cba6c608ecf 61314-237 HUMAN PRESCRIPTION DRUG Cromolyn Sodium Cromolyn Sodium SOLUTION/ DROPS OPHTHALMIC 19990629 ANDA ANDA075282 Sandoz Inc CROMOLYN SODIUM 40 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 61314-238_42565981-7e64-4080-8195-034fd5ca0565 61314-238 HUMAN PRESCRIPTION DRUG Carteolol Hydrochloride Carteolol Hydrochloride SOLUTION OPHTHALMIC 20000105 ANDA ANDA075476 Sandoz Inc CARTEOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61314-245_2c681cb2-e1db-4348-ba8d-4481e601ca45 61314-245 HUMAN PRESCRIPTION DRUG Betaxolol Hydrochloride Betaxolol Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20000515 NDA AUTHORIZED GENERIC NDA019270 Sandoz Inc BETAXOLOL HYDROCHLORIDE 5.6 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61314-271_4acb46b1-dc71-4920-a275-69344ad50164 61314-271 HUMAN PRESCRIPTION DRUG olopatadine hydrochloride olopatadine hydrochloride SOLUTION/ DROPS OPHTHALMIC 20150915 NDA AUTHORIZED GENERIC NDA020688 Sandoz Inc. OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 61314-272_edb2a469-db04-4f9c-b221-f821ef9e70e3 61314-272 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride Olopatadine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20070215 NDA AUTHORIZED GENERIC NDA021545 Sandoz Inc OLOPATADINE HYDROCHLORIDE 2 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 61314-294_b7a09f68-4a8f-4689-b932-99fd1c7b9791 61314-294 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION OPHTHALMIC 20040701 ANDA ANDA088771 Sandoz Inc DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61314-297_f0f52b95-0d34-43a0-b9da-cb2da4ad68d4 61314-297 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium and Prednisolone Sodium Phosphate Sulfacetamide Sodium and Prednisolone Sodium Phosphate SOLUTION OPHTHALMIC 20040309 ANDA ANDA073630 Falcon Pharmaceuticals, Ltd. SULFACETAMIDE SODIUM; PREDNISOLONE SODIUM PHOSPHATE 100; 2.5 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61314-304_1dde2a6f-bcf7-42d6-83ef-2069f362c3b4 61314-304 HUMAN PRESCRIPTION DRUG ZARXIO filgrastim-sndz INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20150306 BLA BLA125553 Sandoz Inc FILGRASTIM, LICENSE HOLDER UNSPECIFIED 300 ug/.5mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] N 20181231 61314-308_b88c8d88-556c-458b-9002-980e0e26fe3a 61314-308 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride azelastine hydrochloride SOLUTION/ DROPS INTRAOCULAR 20130321 ANDA ANDA202305 Sandoz Inc AZELASTINE HYDROCHLORIDE .5 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 61314-312_1dde2a6f-bcf7-42d6-83ef-2069f362c3b4 61314-312 HUMAN PRESCRIPTION DRUG ZARXIO filgrastim-sndz INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20150306 BLA BLA125553 Sandoz Inc FILGRASTIM, LICENSE HOLDER UNSPECIFIED 480 ug/.8mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] N 20181231 61314-320_8b7cf641-ad3e-492c-a473-1e75e6458ec4 61314-320 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride olopatadine hydrochloride SPRAY, METERED NASAL 20150401 NDA AUTHORIZED GENERIC NDA021861 Sandoz Inc OLOPATADINE HYDROCHLORIDE 665 ug/100uL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 61314-354_5c50b964-b481-8062-2a22-6d25d821e8c7 61314-354 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 20000609 ANDA ANDA084305 Sandoz Inc. TROPICAMIDE 5 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 61314-355_5c50b964-b481-8062-2a22-6d25d821e8c7 61314-355 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 20000613 ANDA ANDA084306 Sandoz Inc. TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 61314-396_045e8129-2a07-1cfc-2d85-05ce7e8df314 61314-396 HUMAN PRESCRIPTION DRUG Cyclopentolate Hydrochloride Cyclopentolate Hydrochloride SOLUTION OPHTHALMIC 20020822 ANDA ANDA084110 Sandoz Inc. CYCLOPENTOLATE HYDROCHLORIDE 10 mg/mL N 20181231 61314-447_7b9dcce8-eee0-4805-8652-cde9548a5e5f 61314-447 HUMAN PRESCRIPTION DRUG Metipranolol Metipranolol SOLUTION/ DROPS OPHTHALMIC 20010809 ANDA ANDA075720 Falcon Pharmaceuticals, Ltd. METIPRANOLOL 3 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61314-547_b5057189-a1a0-4282-a86d-0c8c5758fc85 61314-547 HUMAN PRESCRIPTION DRUG Latanoprost Latanoprost SOLUTION OPHTHALMIC 20110107 ANDA ANDA091449 Sandoz Inc LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 61314-628_19c72ff5-70b5-4118-bedf-cc8e55a06336 61314-628 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim SOLUTION OPHTHALMIC 19980416 ANDA ANDA064211 Sandoz Inc POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20191231 61314-630_95e3fde7-e757-4594-8b8c-17fee4a5990f 61314-630 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone neomycin sulfate, polymyxin b sulfate and dexamethasone SUSPENSION OPHTHALMIC 19960221 ANDA ANDA062341 Sandoz Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61314-631_7fa1f97b-389e-480c-b9df-80f8136920b1 61314-631 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin and Polymyxin B Sulfates and Dexamethasone OINTMENT OPHTHALMIC 19960221 NDA AUTHORIZED GENERIC NDA050065 Sandoz Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/g; [iU]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 61314-633_53c582bc-f0a4-4c8e-9470-1382c902ad67 61314-633 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION OPHTHALMIC 19960405 ANDA ANDA062196 Sandoz Inc GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 61314-637_cd22950c-4252-a954-e3d8-c2cbf2094d07 61314-637 HUMAN PRESCRIPTION DRUG Prednisolone Acetate Prednisolone Acetate SUSPENSION/ DROPS OPHTHALMIC 19941215 NDA AUTHORIZED GENERIC NDA017469 Sandoz Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61314-641_1afc7838-afea-4c2b-8768-d7c30541d800 61314-641 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SUSPENSION OPHTHALMIC 20030509 ANDA ANDA062874 Sandoz Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 61314-643_70601d86-389b-473c-8d47-641c47a7ebc4 61314-643 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19950109 ANDA ANDA062535 Sandoz Inc TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 61314-645_63ff03cc-a220-432b-99a3-d74eb286c398 61314-645 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SUSPENSION AURICULAR (OTIC) 20030317 ANDA ANDA062488 Sandoz Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61314-646_a7f5dc0a-1ab9-45d7-b227-8a060dfba5b5 61314-646 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SOLUTION AURICULAR (OTIC) 20030318 ANDA ANDA062423 Sandoz Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [iU]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 61314-647_676c4dcc-580f-7454-fab4-3142ed87fcdd 61314-647 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 20090102 NDA AUTHORIZED GENERIC NDA050592 Sandoz Inc. TOBRAMYCIN; DEXAMETHASONE 3; 1 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61314-656_84df14ec-75fb-3b46-aa87-e9b3eac5a820 61314-656 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20040507 NDA AUTHORIZED GENERIC NDA019992 Sandoz Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 61314-665_de886297-ac5b-5c43-bf59-b863e5daebd8 61314-665 HUMAN PRESCRIPTION DRUG Apraclonidine Apraclonidine SOLUTION OPHTHALMIC 20090719 NDA AUTHORIZED GENERIC NDA020258 Sandoz Inc. APRACLONIDINE HYDROCHLORIDE 5.75 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 61314-672_9e6fcd14-1fee-493f-811c-e18cbfbee65b 61314-672 HUMAN PRESCRIPTION DRUG Gatifloxacin gatifloxacin SOLUTION/ DROPS OPHTHALMIC 20161003 ANDA ANDA204227 Sandoz Inc GATIFLOXACIN 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 61314-701_36f8f0f7-5542-4dd7-a551-db8f06df2501 61314-701 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SOLUTION OPHTHALMIC 20030325 ANDA ANDA089560 Sandoz Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 61315-010_f467eaba-25e3-44cc-b9dc-2bc5fccb009a 61315-010 HUMAN OTC DRUG Arllin Golden Combination Charisma CC Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Golden Bridge International TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.9; 1.5; .88 mg/30mL; mg/30mL; mg/30mL E 20171231 61324-464_62cb7b43-231c-46e9-bbae-733d587630b5 61324-464 HUMAN OTC DRUG Ausanil capsaicin ginger SPRAY, METERED NASAL 20140314 UNAPPROVED HOMEOPATHIC VR1 Corporation CAPSICUM SPP.; GINGER 3; 3 [hp_X]/8mL; [hp_X]/8mL E 20171231 61327-0015_4f2fccd8-70ba-4cfe-a31e-617c5f981768 61327-0015 HUMAN OTC DRUG Instant Hand Sanitizer TENNder CARE ETHYL ALCOHOL GEL TOPICAL 20131210 OTC MONOGRAPH NOT FINAL part333E AMC Promotional Products ALCOHOL 62 mL/100mL N 20181231 61328-001_535621dd-c4e6-47c0-8f02-0c4698acb61a 61328-001 HUMAN OTC DRUG Diaper Rash Balm Skin Protectant OINTMENT TOPICAL 20131209 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ZINC OXIDE .2 g/g E 20171231 61328-001_ceef5837-e43b-48bf-a886-41e8dc9effdc 61328-001 HUMAN OTC DRUG Diaper Rash Balm Skin Protectant OINTMENT TOPICAL 20131209 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ZINC OXIDE .2 g/g E 20171231 61328-005_3055571d-6da0-4325-8962-ca9e3f8d5e74 61328-005 HUMAN OTC DRUG Kids Eczema Balm Skin Protectant OINTMENT TOPICAL 20140409 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL .02 g/g E 20171231 61328-007_0fae0bd8-e979-450e-9e69-3efc4f43762e 61328-007 HUMAN OTC DRUG Healing Foot and Leg Balm Skin Protectant OINTMENT TOPICAL 20131219 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ALLANTOIN .02 g/g E 20171231 61328-009_99d4acab-8c90-4e67-801e-1fd799c3eac6 61328-009 HUMAN OTC DRUG Body Repair Balm Oatmeal OINTMENT TOPICAL 20131209 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL .2 g/g E 20171231 61328-101_c84a6da7-7a62-41e2-a366-08aa8342e357 61328-101 HUMAN OTC DRUG 12 Hour Miracle Allantoin OINTMENT TOPICAL 20150523 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ALLANTOIN .5 g/100g N 20181231 61328-102_fe690ba7-fadc-4a92-a1eb-f1430ea15020 61328-102 HUMAN OTC DRUG Eczema Plus Soothing Colloidal Oatmeal LOTION TOPICAL 20150523 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL 1 g/100mL E 20171231 61328-103_d548ace3-5040-4956-80b3-da3efac6fcf8 61328-103 HUMAN OTC DRUG Eczema Plus Soothing Body Colloidal Oatmeal CREAM TOPICAL 20150523 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL 2 g/100mL N 20181231 61328-104_be5083f2-67ed-4ce1-8715-f82d24668c8e 61328-104 HUMAN OTC DRUG GENTLE ECZEMA BALM Colloidal Oatmeal OINTMENT TOPICAL 20131209 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL 2 g/100g E 20171231 61328-106_26be3f4f-9c31-42f1-bb64-0f77b73e0fac 61328-106 HUMAN OTC DRUG SKINFIX HAND REPAIR OATMEAL CREAM TOPICAL 20140702 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL 1 g/100mL N 20181231 61328-107_02b435c0-a43c-4c1e-be8e-67e669ba0bc8 61328-107 HUMAN OTC DRUG Eczema Sheer Face Colloidal Oatmeal OINTMENT TOPICAL 20150523 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL 5 g/100g E 20171231 61328-108_54e2431a-736c-4c19-8a2c-323e4270b041 61328-108 HUMAN OTC DRUG Kids Eczema Sheer Face Colloidal Oatmeal OINTMENT TOPICAL 20170227 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL 5 g/100g N 20181231 61328-110_7164c520-8a54-490b-a993-2a469a34d138 61328-110 HUMAN OTC DRUG Rash Repair Balm ZINC OXIDE OINTMENT TOPICAL 20160920 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ZINC OXIDE .2 g/g E 20171231 61328-111_b2ec66cd-8577-486f-9e86-82318496f62c 61328-111 HUMAN OTC DRUG Eczema Plus Kids Soothing Body Cream Colloidal Oatmeal CREAM TOPICAL 20161114 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL 1 mg/mg E 20171231 61328-113_f04594aa-c0c4-43b1-a27f-4a1850bfad40 61328-113 HUMAN OTC DRUG Baby Gentle Eczema Plus Soothing Body Colloidal Oatmeal CREAM TOPICAL 20170227 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL 1 mg/100mg N 20181231 61328-114_1dfdba62-ddc4-40ed-83e9-f4de2b506f2d 61328-114 HUMAN OTC DRUG Baby Gentle Eczema Sheer Face Colloidal Oatmeal OINTMENT TOPICAL 20170227 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL 3 g/100g N 20181231 61328-115_54532f8e-59a4-486a-b2a8-c9d5e2a6a4c6 61328-115 HUMAN OTC DRUG Eczema Balm Oatmeal OINTMENT TOPICAL 20150523 OTC MONOGRAPH FINAL part347 Skinfix, Inc. OATMEAL 2 g/100g N 20181231 61328-116_cc35868f-2f0b-4832-a936-479f4cc19da8 61328-116 HUMAN OTC DRUG 12 Hour Healing Allantoin OINTMENT TOPICAL 20170502 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ALLANTOIN .5 g/100g N 20181231 61328-301_66844813-f3e0-479c-9329-3faa7b5a22f1 61328-301 HUMAN OTC DRUG INKED ALLANTOIN OINTMENT TOPICAL 20150523 OTC MONOGRAPH FINAL part347 Skinfix, Inc. ALLANTOIN .5 g/100g N 20181231 61328-901_0cfd026c-7ccc-4443-a2a6-6f3801cd2cc0 61328-901 HUMAN OTC DRUG DAILY ECZEMA REGIMEN OATMEAL KIT 20150702 OTC MONOGRAPH FINAL part347 Skinfix, Inc. E 20171231 61330-123_231a91bd-6c6d-23dd-e054-00144ff88e88 61330-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20151027 UNAPPROVED MEDICAL GAS Brevard Medical Equipment OXYGEN 99 L/100L E 20171231 61333-201_e0c7faeb-80b2-4039-8c7e-2bdd3ca6834e 61333-201 HUMAN OTC DRUG Lights Povidone Iodine Solution POVIDONE-IODINE SOLUTION TOPICAL 20140222 OTC MONOGRAPH FINAL part333C Lights Medical Manufacture Co., Ltd. POVIDONE-IODINE 1.18 g/118mL N 20181231 61333-202_41e4a364-3d6f-4f01-8f5d-669d1669bf68 61333-202 HUMAN OTC DRUG Lights Povidone Iodine Solution POVIDONE-IODINE SOLUTION TOPICAL 20140322 OTC MONOGRAPH FINAL part333C Lights Medical Manufacture Co., Ltd. POVIDONE-IODINE 1.18 g/118mL N 20181231 61333-203_3b99ad81-a4a0-4e89-a9a3-cab3d901ef0a 61333-203 HUMAN OTC DRUG Lights Povidone Iodine Prep Pad POVIDONE-IODINE SOLUTION TOPICAL 20151015 OTC MONOGRAPH FINAL part333C Lights Medical Manufacture Co., Ltd. POVIDONE-IODINE 1 g/100g N 20181231 61333-500_cf6da511-b97f-46d0-a626-5f53f999bf77 61333-500 HUMAN OTC DRUG BZK Antiseptic benzalkonium chloride SWAB TOPICAL 20150506 OTC MONOGRAPH NOT FINAL part333E Lights Medical Manufacture Co., Ltd. BENZALKONIUM CHLORIDE .13 mg/100mg N 20181231 61336-001_7d497849-67ad-43c3-b9bf-050175048a84 61336-001 HUMAN PRESCRIPTION DRUG Oxygen, Compressed OXYGEN LIQUID RESPIRATORY (INHALATION) 20120524 UNAPPROVED MEDICAL GAS Gulf State Chemical and Welding Supply Inc. OXYGEN 1 L/L N 20181231 61352-001_e7b38b45-1081-4732-9e2d-cb7f074e0a27 61352-001 HUMAN OTC DRUG Clinicians Complex Sulfur LOTION TOPICAL 20131211 OTC MONOGRAPH FINAL part333D Cosmed, Inc. SULFUR 100 mg/g E 20171231 61352-003_229c52ec-235f-4a11-a73e-58cf26e0f656 61352-003 HUMAN OTC DRUG Total Sun Protection Octinoxate, Zinc Oxide, Octisalate, Oxybenzone LOTION TOPICAL 20130801 OTC MONOGRAPH FINAL part352 Cosmed, Inc. OCTINOXATE; ZINC OXIDE; OCTISALATE; OXYBENZONE 75; 38; 30; 30 mg/g; mg/g; mg/g; mg/g E 20171231 61355-569_b4e44dcb-765c-40dc-87be-4c7bc3bfbd09 61355-569 HUMAN OTC DRUG Toppik Womens Hair Regrowth Treatment Minoxidil SOLUTION TOPICAL 20140101 ANDA ANDA078176 Spencer Forrest, Inc. MINOXIDIL 20 mg/mL E 20171231 61355-570_3525ff6e-0a3c-443d-8729-8d36399fd70c 61355-570 HUMAN OTC DRUG Toppik Mens Hair Regrowth Treatment Extra Strength Minoxidil SOLUTION TOPICAL 20140101 ANDA ANDA076239 Spencer Forrest, Inc. MINOXIDIL 50 mg/mL E 20171231 61357-130_0639fa84-e31c-45f7-ad6a-cae2099e321b 61357-130 HUMAN OTC DRUG Hemorrodil Unguento Zinc Oxide OINTMENT RECTAL 19640301 OTC MONOGRAPH FINAL part346 ZURICH MEDICAL LABS, LLC ZINC OXIDE 50 mg/g E 20171231 61357-135_5a877b42-8cce-4c0a-a2ef-3324577ad4d2 61357-135 HUMAN OTC DRUG Hemorrodil PHENYLEPHRINE HYDROCHLORIDE and COCOA BUTTER SUPPOSITORY RECTAL 19640301 OTC MONOGRAPH FINAL part346 ZURICH MEDICAL LABS, LLC PHENYLEPHRINE HYDROCHLORIDE; COCOA BUTTER 5; 1768.8 mg/1; mg/1 E 20171231 61357-146_39fa6269-46d0-476f-8516-310465dcc67e 61357-146 HUMAN OTC DRUG Sanafitil Undecylenic Acid LIQUID TOPICAL 19660824 OTC MONOGRAPH FINAL part333C ZURICH MEDICAL LABS, LLC UNDECYLENIC ACID 100 mg/mL E 20171231 61357-149_e56542a5-1348-43e0-b28f-8056e4b8cdd1 61357-149 HUMAN OTC DRUG Sanafitil Undecylenic Acid OINTMENT TOPICAL 19660824 OTC MONOGRAPH FINAL part333C ZURICH MEDICAL LABS, LLC UNDECYLENIC ACID 100 mg/g E 20171231 61357-152_4b57c6de-c555-41a0-8789-4cc84a62f16b 61357-152 HUMAN OTC DRUG Sanafitil Talco UNDECYLENIC ACID and ZINC UNDECYLENATE POWDER TOPICAL 19660824 OTC MONOGRAPH FINAL part333C ZURICH MEDICAL LABS, LLC UNDECYLENIC ACID; ZINC UNDECYLENATE 20; 200 mg/g; mg/g E 20171231 61358-040_f1276617-860b-46f6-8c7a-4de14559f5fc 61358-040 HUMAN OTC DRUG FIVE PHOTO BRAND FIRST AID ANTISEPTIC ALCOHOL LIQUID TOPICAL 20080104 OTC MONOGRAPH NOT FINAL part333A LUNG CHOY SHUNG FIVE PHOTOS BRAND MEDICINE FTY ALCOHOL 70 g/100mL N 20181231 61358-100_e7f9b97a-bb8f-4300-a60e-92fe97f4eb90 61358-100 HUMAN OTC DRUG FIVE PHOTO BRAND FIRST AID ANTISEPTIC ALCOHOL LIQUID TOPICAL 20160808 OTC MONOGRAPH NOT FINAL part333A LUNG CHOY SHUNG FIVE PHOTOS BRAND MEDICINE FTY ALCOHOL 48 g/100mL N 20181231 61360-1351_9880db7c-4fdf-42b4-b415-67c224f7838a 61360-1351 HUMAN PRESCRIPTION DRUG Ciclopirox ciclopirox SHAMPOO TOPICAL 20110223 ANDA ANDA090269 Taro Pharmaceuticals, Inc. CICLOPIROX 10 mg/.96mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 61360-2002_d8b394a8-0f31-474c-b38e-958c0739bf5c 61360-2002 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C Taro Pharmaceuticals, Inc. CLOTRIMAZOLE 1 g/100g N 20181231 61360-2020_15ae5419-e1b9-4192-a427-358f1c57d31f 61360-2020 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20090820 OTC MONOGRAPH FINAL part333 Taro Pharmaceuticals, Inc. TOLNAFTATE 1 g/100g N 20181231 61360-2037_144facde-3654-4afc-873b-c2517b8ff810 61360-2037 HUMAN OTC DRUG Clotrimazole Clotrimazole SOLUTION TOPICAL 19960501 OTC MONOGRAPH FINAL part333C Taro Pharmaceuticals, Inc. CLOTRIMAZOLE 1 g/mL N 20181231 61361-820_d1e271c3-82f1-4030-84bb-4dadf26c1097 61361-820 HUMAN OTC DRUG Pasmol Pain Relieving Menthol and Methyl Salicylate CREAM TOPICAL 20150408 OTC MONOGRAPH NOT FINAL part348 Grafor, Inc. MENTHOL; METHYL SALICYLATE 5; 14 g/100g; g/100g E 20171231 61362-2150_e1541825-4194-4176-bb03-cd078f2a7b7a 61362-2150 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Reliance Oxygen & Equipment OXYGEN 99 L/100L E 20171231 61364-181_81cacc91-52f2-43ce-a883-41352b1bbed3 61364-181 HUMAN PRESCRIPTION DRUG RAPIVAB Peramivir SOLUTION INTRAVENOUS 20141220 NDA NDA206426 bioCSL Inc. PERAMIVIR 600 mg/60mL N 20181231 61369-101_e43b28c4-390f-45eb-a51b-645339206782 61369-101 HUMAN OTC DRUG KLENSKIN SHOWERON SUNSCREEN SPF-30 AVOBENZONE, OCTOCRYLENE, OCTINOXATE GEL TOPICAL 20140728 OTC MONOGRAPH FINAL part352 CoLabs Intl. Corp AVOBENZONE; OCTOCRYLENE; OCTINOXATE 2.75; 7.04; 7.2 g/100mL; g/100mL; g/100mL N 20181231 61369-102_e06360e1-8aa1-4148-a9a2-552f2ef076c2 61369-102 HUMAN OTC DRUG KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30 AVOBENZONE, OCTOCRYLENE, OCTINOXATE GEL TOPICAL 20140728 OTC MONOGRAPH FINAL part352 CoLabs Intl. Corp AVOBENZONE; OCTOCRYLENE; OCTINOXATE 2.75; 7.04; 7.2 g/100mL; g/100mL; g/100mL N 20181231 61369-103_91facb80-1775-4d79-bd6c-48ccc37f577a 61369-103 HUMAN OTC DRUG KLENSKIN SHOWERON SUNSCREEN SPA SPF-30 AVOBENZONE, OCTOCRYLENE, OCTINOXATE GEL TOPICAL 20140728 OTC MONOGRAPH FINAL part352 CoLabs Intl. Corp AVOBENZONE; OCTOCRYLENE; OCTINOXATE 2.75; 7.04; 7.2 g/100mL; g/100mL; g/100mL N 20181231 61369-104_b91b7cac-e0da-4ad3-852a-63111e7c171f 61369-104 HUMAN OTC DRUG KLENSKIN SUNBAR SPF-20 OCTINOXATE, OCTOCRYLENE, AVOBENZONE SOAP TOPICAL 20160317 OTC MONOGRAPH FINAL part352 CoLabs Intl. Corp AVOBENZONE; OCTOCRYLENE; OCTINOXATE 1.6; 4.2; 5.2 g/100g; g/100g; g/100g N 20181231 61369-201_77efb622-ff6a-453c-a59d-223e7eba1d79 61369-201 HUMAN OTC DRUG KLENSKIN BROAD SPECTRUM SPF-50 AVOBENZONE, OCTOCRYLENE, OCTINOXATE LOTION TOPICAL 20160416 OTC MONOGRAPH FINAL part352 CoLabs Intl. Corp AVOBENZONE; OCTOCRYLENE; OCTINOXATE 2.1; 5.4; 5 g/100mL; g/100mL; g/100mL N 20181231 61380-156_2a70cf02-7edb-4a85-9acd-98ff116e63f3 61380-156 HUMAN OTC DRUG Natures Gate Aqua SPF 50 HOMOSALATE, OCTINOXATE, OCTISALATE, and ZINC OXIDE LOTION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC HOMOSALATE; OCTINOXATE; OCTISALATE; ZINC OXIDE 100; 75; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 61380-161_6f863c19-66f4-440e-8d8a-0d86a8331412 61380-161 HUMAN OTC DRUG Natures Gate Sport SPF 50 HOMOSALATE, OCTINOXATE, OCTISALATE, and ZINC OXIDE LOTION TOPICAL 20170205 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC HOMOSALATE; OCTINOXATE; OCTISALATE; ZINC OXIDE 100; 75; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 61380-166_7699bd4c-8240-4385-aafd-2e0d70f87c94 61380-166 HUMAN OTC DRUG Natures Gate Kids SPF 50 HOMOSALATE, OCTINOXATE, OCTISALATE, and ZINC OXIDE LOTION TOPICAL 20170614 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC HOMOSALATE; OCTINOXATE; OCTISALATE; ZINC OXIDE 100; 75; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 61380-167_99f1135a-ef8c-4bc6-b33c-1f0750790cf1 61380-167 HUMAN OTC DRUG Natures Gate Face SPF 25 HOMOSALATE, OCTINOXATE, and ZINC OXIDE LOTION TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC HOMOSALATE; OCTINOXATE; ZINC OXIDE 75; 75; 80 mg/mL; mg/mL; mg/mL N 20181231 61380-303_1a9cf13b-e222-498e-aa6e-2ec85ad04cfb 61380-303 HUMAN OTC DRUG Natures Gate Face Broad Spectrum Sunscreen SPF 25 OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20121120 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 75; 70; 69 mg/mL; mg/mL; mg/mL E 20171231 61380-310_db1c3750-d09a-4ac2-a768-65d1ee131c25 61380-310 HUMAN OTC DRUG Natures Gate Kids SPF 20 Mineral TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20120612 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC TITANIUM DIOXIDE; ZINC OXIDE 83; 20 mg/mL; mg/mL N 20181231 61380-311_4f2359b5-e760-41d6-bb51-7b5f45fd5f9f 61380-311 HUMAN OTC DRUG Natures Gate Sport SPF 20 Mineral TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20130214 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC TITANIUM DIOXIDE; ZINC OXIDE 83; 20 mg/mL; mg/mL N 20181231 61380-312_5c2eb043-410b-4af2-b578-327853259c41 61380-312 HUMAN OTC DRUG Natures Gate Aqua SPF 50 OCTINOXATE, OCTISALATE, OCTOCRYLENE, and ZINC OXIDE LOTION TOPICAL 20120618 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 75; 50; 70; 69 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 61380-313_8106605e-0ad4-4f0d-a996-58eda0a21c20 61380-313 HUMAN OTC DRUG Natures Gate Sport SPF 50 Octinoxate, Octisalate, Octocrylene, and Zinc Oxide LOTION TOPICAL 20120614 OTC MONOGRAPH NOT FINAL part352 Levlad, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 75; 50; 70; 69 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 61380-314_2cf5cb52-307d-4197-80fa-0775283d6b51 61380-314 HUMAN OTC DRUG Natures Gate kids SPF 50 octinoxate, octisalate, octocrylene, and zinc oxide LOTION TOPICAL 20120615 OTC MONOGRAPH NOT FINAL part352 Levlad LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 75; 50; 70; 69 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 61383-018_920bd114-2794-4196-84f6-8ce92df1ebbb 61383-018 HUMAN OTC DRUG Cold Sore TREATMENT Allantoin, Lidocaine GEL TOPICAL 20171201 OTC MONOGRAPH FINAL part347 Dimensional Merchandising Inc. ALLANTOIN; LIDOCAINE .5; .5 g/100g; g/100g N 20191231 61383-201_d2af787c-c2f5-40bd-bfdc-cd3dc5aa4846 61383-201 HUMAN OTC DRUG Photo Plasma Titanium Dioxide CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 Dimensional Merchandising Inc. TITANIUM DIOXIDE 4.2 g/100mL N 20181231 61383-501_bebd104d-38e8-4319-a9b0-f4f7e4b8fcf0 61383-501 HUMAN OTC DRUG Face Finishing Moisturizer Tint Titanium Dioxide CREAM TOPICAL 20150212 OTC MONOGRAPH FINAL part352 Dimensional Merchandising Inc. TITANIUM DIOXIDE 5.6601 g/100mL N 20181231 61383-601_670a7ffd-3b61-440d-9e2d-ec283e48bba1 61383-601 HUMAN OTC DRUG rosacea treatment gel Sulfur GEL TOPICAL 20141210 UNAPPROVED HOMEOPATHIC Dimensional Merchandising Inc. SULFUR 1 [hp_X]/g N 20181231 61383-701_de53d1ea-149f-416c-8cb3-00e60c53970b 61383-701 HUMAN OTC DRUG Muscle and Joint Pain Relief Gel Menthol, Eucalyptus Globulus Leaf Oil GEL TOPICAL 20161116 OTC MONOGRAPH NOT FINAL part348 Dimensional Merchandising Inc. MENTHOL, UNSPECIFIED FORM; EUCALYPTUS OIL 5; 3.25 g/100g; g/100g N 20181231 61387-247_0eb69072-bd98-48c3-873b-b57ab18d7765 61387-247 HUMAN OTC DRUG TrueLipids Anti-Itch Barrier Hydrocortisone CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part348 DermDeal, LLC dba Cheryl Lee, MD Sensitive Skin Care HYDROCORTISONE 1 g/100mL N 20181231 61387-248_b6e8217b-9c6e-4e66-8980-e3a01fe474c2 61387-248 HUMAN OTC DRUG White Petrolatum CheryLee MD Sensitive Skin Care TrueLipids Double Action Boo-Boo Bum OINTMENT TOPICAL 20140301 OTC MONOGRAPH FINAL part346 DermDeal, LLC DBA CheryLee MD, Sensitive Skin Care PETROLATUM 50 g/100g N 20181231 61387-249_78606447-29e2-4dc1-99a5-e82cc898f754 61387-249 HUMAN OTC DRUG White Petrolatum CheryLee MD Sensitive Skin Care TrueLipids Relieve and Protect Ointment OINTMENT TOPICAL 20140301 OTC MONOGRAPH FINAL part346 DermDeal, LLC DBA CheryLee MD, Sensitive Skin Care PETROLATUM 50 g/100g N 20181231 61387-250_3c1a34e7-da34-41a2-985c-fc0eeb517c9f 61387-250 HUMAN OTC DRUG White Petrolatum CherylLee MD Sensitive Skin Care TrueLipids TrueLips Lip Balm OINTMENT TOPICAL 20140301 OTC MONOGRAPH FINAL part346 DermDeal, LLC DBA CheryLee MD, Sensitive Skin Care PETROLATUM 50 g/100g N 20181231 61388-001_8a718360-be4c-4dea-b9bc-e9e4beff29b5 61388-001 HUMAN PRESCRIPTION DRUG Zingo lidocaine hydrochloride monohydrate POWDER INTRADERMAL 20150105 NDA NDA022114 Powder Pharmaceuticals Inc. LIDOCAINE HYDROCHLORIDE .5 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 61393-0003_635fe378-13ab-1cec-e053-2991aa0a15a1 61393-0003 HUMAN PRESCRIPTION DRUG Oxygen Compressed UN 1072 Refrigerated UN 1073 OXYGEN GAS RESPIRATORY (INHALATION) 20180119 UNAPPROVED DRUG OTHER RCC Medical Supply OXYGEN 1 L/L N 20191231 61398-0828_57fb5499-18d5-44b5-9477-7e04e8f8e08d 61398-0828 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19941001 UNAPPROVED MEDICAL GAS Complete Care Inc OXYGEN 99 L/100L E 20171231 61402-7131_8f579c82-1e86-401b-a8fc-97a4a65f49d4 61402-7131 HUMAN OTC DRUG Reclarx Moisture Shield Octocrylene and Avobenzone CREAM TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 NBC Aesthetics, LLC OCTOCRYLENE; AVOBENZONE 7; 2 g/100mL; g/100mL E 20171231 61403-020_14d150ca-7d4d-4656-a633-d8b8b37726c7 61403-020 HUMAN OTC DRUG Ceravine Original Moisturizing Multi-purpose Oatmeal JELLY TOPICAL 20150724 OTC MONOGRAPH FINAL part347 Biostandard Inc. OATMEAL .0485 g/50g E 20171231 61403-030_564e7052-6226-442f-a229-f7839d93b4e3 61403-030 HUMAN OTC DRUG Ceravine Lip Balm Oatmeal STICK TOPICAL 20150804 OTC MONOGRAPH FINAL part347 Biostandard Inc. OATMEAL .0003 g/5g E 20171231 61420-0001_dfb3f082-be0e-41db-ac31-a180886990c2 61420-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19940501 UNAPPROVED MEDICAL GAS Dillon Medical Supply OXYGEN 99 L/100L E 20171231 61442-101_544dfee7-435e-6f28-e054-00144ff8d46c 61442-101 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Carlsbad Technology, Inc. DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61442-102_544dfee7-435e-6f28-e054-00144ff8d46c 61442-102 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Carlsbad Technology, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61442-103_544dfee7-435e-6f28-e054-00144ff8d46c 61442-103 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Carlsbad Technology, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 61442-111_5c4c54b8-d9ec-4688-9bdd-625ac87eb599 61442-111 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20091022 ANDA ANDA075090 Carlsbad Technology, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 61442-112_05a086ae-783a-39ad-e054-00144ff88e88 61442-112 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 Carlsbad Technology, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 61442-113_05a086ae-783a-39ad-e054-00144ff88e88 61442-113 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 Carlsbad Technology, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 61442-114_588e5f89-5d51-2522-e053-2991aa0ae0c0 61442-114 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20170817 ANDA ANDA206261 Carlsbad Technology, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 61442-115_1b05d878-4e5f-632c-e054-00144ff88e88 61442-115 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120101 ANDA ANDA077911 Carlsbad Technology, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 61442-116_1b05d878-4e5f-632c-e054-00144ff88e88 61442-116 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120101 ANDA ANDA077911 Carlsbad Technology, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 61442-117_1b05d878-4e5f-632c-e054-00144ff88e88 61442-117 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120101 ANDA ANDA077911 Carlsbad Technology, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 61442-121_88518123-8f7b-4eb7-a1a1-a94c7d422141 61442-121 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Carlsbad Technology, Inc FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 61442-122_88518123-8f7b-4eb7-a1a1-a94c7d422141 61442-122 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Carlsbad Technology, Inc FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 61442-126_28dc394f-c736-2103-e054-00144ff88e88 61442-126 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 Carlsbad Technology, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61442-127_28dc394f-c736-2103-e054-00144ff88e88 61442-127 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 Carlsbad Technology, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61442-141_59c9970a-4e12-2206-e053-2a91aa0ad657 61442-141 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Carlsbad Technology, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61442-142_59c9970a-4e12-2206-e053-2a91aa0ad657 61442-142 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Carlsbad Technology, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61442-143_59c9970a-4e12-2206-e053-2a91aa0ad657 61442-143 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Carlsbad Technology, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61442-161_af92ea41-b5dd-433d-9c09-b103240f2853 61442-161 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101015 ANDA ANDA065152 Carlsbad Technology, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61442-162_af92ea41-b5dd-433d-9c09-b103240f2853 61442-162 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101015 ANDA ANDA065152 Carlsbad Technology, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61442-171_33045f3a-7875-439d-a6e4-60df32a821d3 61442-171 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 20080731 ANDA ANDA065146 Carlsbad Technology, Inc. CEFACLOR 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61442-172_33045f3a-7875-439d-a6e4-60df32a821d3 61442-172 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 20080731 ANDA ANDA065146 Carlsbad Technology, Inc. CEFACLOR 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61442-173_2632c343-21cc-4563-96b3-ac1f0c78dae6 61442-173 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20120327 ANDA ANDA065412 Carlsbad Technology, Inc. CEFACLOR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61442-174_2632c343-21cc-4563-96b3-ac1f0c78dae6 61442-174 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20120327 ANDA ANDA065412 Carlsbad Technology, Inc. CEFACLOR 187 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61442-175_2632c343-21cc-4563-96b3-ac1f0c78dae6 61442-175 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20120327 ANDA ANDA065412 Carlsbad Technology, Inc. CEFACLOR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61442-176_2632c343-21cc-4563-96b3-ac1f0c78dae6 61442-176 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor SUSPENSION ORAL 20120327 ANDA ANDA065412 Carlsbad Technology, Inc. CEFACLOR 375 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61442-201_e3757196-10ac-43b5-8ce1-2da9cbda14c9 61442-201 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin SUSPENSION ORAL 20090601 ANDA ANDA065336 Carlsbad Technology, Inc. CEPHALEXIN 125 mg/5mL N 20181231 61442-202_e3757196-10ac-43b5-8ce1-2da9cbda14c9 61442-202 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin SUSPENSION ORAL 20090601 ANDA ANDA065336 Carlsbad Technology, Inc. CEPHALEXIN 250 mg/5mL N 20181231 61442-222_592f5504-fe8f-36e4-e053-2991aa0a2347 61442-222 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20091010 ANDA ANDA076126 Carlsbad Technology, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 61442-223_592f5504-fe8f-36e4-e053-2991aa0a2347 61442-223 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20091010 ANDA ANDA076126 Carlsbad Technology, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 61442-224_592f5504-fe8f-36e4-e053-2991aa0a2347 61442-224 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20091010 ANDA ANDA076126 Carlsbad Technology, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 61442-231_14e44cf8-d4c1-5424-e054-00144ff88e88 61442-231 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET ORAL 20070423 ANDA ANDA077990 Carlsbad Technology, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 61442-232_14e44cf8-d4c1-5424-e054-00144ff88e88 61442-232 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET ORAL 20070423 ANDA ANDA077990 Carlsbad Technology, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 61442-321_1b1643e8-8b55-404d-e054-00144ff88e88 61442-321 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130617 ANDA ANDA202297 Carlsbad Technology, Inc CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 61442-322_1b1643e8-8b55-404d-e054-00144ff88e88 61442-322 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130617 ANDA ANDA202297 Carlsbad Technology, Inc CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 61442-323_1b1643e8-8b55-404d-e054-00144ff88e88 61442-323 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20130617 ANDA ANDA202297 Carlsbad Technology, Inc CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 61442-361_308dc0ee-f470-376f-e054-00144ff88e88 61442-361 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 Carlsbad Technology, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 61442-362_308dc0ee-f470-376f-e054-00144ff88e88 61442-362 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 Carlsbad Technology, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 61442-363_308dc0ee-f470-376f-e054-00144ff88e88 61442-363 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 Carlsbad Technology, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 61442-450_2eac87c8-285e-205c-e054-00144ff8d46c 61442-450 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20140127 ANDA ANDA203374 Carlsbad Technology, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 61442-460_2e47680c-c285-02ce-e054-00144ff88e88 61442-460 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20151111 ANDA ANDA203646 Carlsbad Technology, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 61442-470_2e32fb7f-e3f5-6415-e054-00144ff88e88 61442-470 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET, COATED ORAL 20160101 ANDA ANDA203176 Carlsbad Technology, Inc. NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 61458-0001_629f28d9-3a88-475c-b59a-32bfe3f374d7 61458-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960601 UNAPPROVED MEDICAL GAS Quality Home Healthcare, Inc. OXYGEN 99 L/100L E 20171231 61474-8135_648f7ae1-f3eb-4969-99b6-be813b1f2272 61474-8135 HUMAN OTC DRUG Robi DM Max Cough Congestion 10ct Blister Guaifenesin and Dextromethorphan Hydrobromide CAPSULE, GELATIN COATED ORAL 20130129 OTC MONOGRAPH FINAL part341 Accucaps Industries Limited GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 200; 10 mg/1; mg/1 N 20181231 61474-8137_91937b68-83d9-40e8-8f7b-a84d9f9aca83 61474-8137 HUMAN OTC DRUG Diphenhydramine HCl 25mg 24ct Blister Diphenhydramine Hydrochloride 25mg CAPSULE, GELATIN COATED ORAL 20160921 OTC MONOGRAPH FINAL part341 Accucaps Industries Limited DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 61476-100_51f15dda-1861-4b68-872d-49cee7c8dce4 61476-100 HUMAN OTC DRUG Zenol Cool METHYL SALICYLATE POULTICE TRANSDERMAL 20131123 OTC MONOGRAPH NOT FINAL part348 Green Cross Corp METHYL SALICYLATE 160 mg/17g N 20181231 61476-101_be85476e-1c35-4857-b175-aaffe82d172a 61476-101 HUMAN OTC DRUG Zenol Mild Hot METHYL SALICYLATE POULTICE TRANSDERMAL 20131203 OTC MONOGRAPH NOT FINAL part348 Green Cross Corp METHYL SALICYLATE 105 mg/17.5g N 20181231 61476-102_797676cd-4dd3-40d9-9e43-dedb508341fb 61476-102 HUMAN OTC DRUG Hanbang Cataplasma MENTHOL POULTICE TRANSDERMAL 20131203 OTC MONOGRAPH NOT FINAL part348 Green Cross Corp MENTHOL 280 mg/12g N 20181231 61477-101_d82dd3db-8dc3-4d78-a454-66e6ded07c90 61477-101 HUMAN OTC DRUG ALOE ICE SUNBURN RELIEF LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part348 Aloe Care International, LLC LIDOCAINE HYDROCHLORIDE 2 g/100mL N 20181231 61477-201_229ecf20-6297-4efa-a2ed-0af94c6e1bf0 61477-201 HUMAN OTC DRUG ALOE ICE SPF 20 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 4; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61477-203_715a6523-282a-4a5e-b0bf-bffff3d5f5db 61477-203 HUMAN OTC DRUG ALOE ICE SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 5; 6; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61477-205_11fe2359-3fea-48d0-b79a-7e8288e1fd5d 61477-205 HUMAN OTC DRUG ALOE UP LIL KIDS SPF 50 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 5; 6; 5; 10 g/100mL; g/100mL; 1/100mL; g/100mL; 1/100mL N 20181231 61477-206_ceea504c-bd03-4956-ac6f-3ad7431d45ac 61477-206 HUMAN OTC DRUG ALOE UP LIL KIDS CONTINUOUS SUNSCREEN SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.75; 4 g/100mL; g/100mL; g/100mL; g/100mL; 1/100mL N 20181231 61477-207_7a11e8c7-0894-43e4-b833-9e03707f7359 61477-207 HUMAN OTC DRUG ALOE UP PRO 15 AVOBENZONE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 1.85 g/100mL; g/100mL; g/100mL N 20181231 61477-208_40958abf-4714-4a95-8ea4-ea83f482ad92 61477-208 HUMAN OTC DRUG ALOE UP PRO SPF 30 ULTRA SPORT SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 3.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61477-209_4e90c283-1fba-4559-863d-d8538d76479f 61477-209 HUMAN OTC DRUG ALOE UP PRO 30 CONTINUOUS SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.75; 2 g/100mL; g/100mL; g/100mL; g/100mL; 1/100mL N 20181231 61477-210_9194139a-3a2f-4a8a-95ee-67a1d8423ee4 61477-210 HUMAN OTC DRUG ALOE UP PRO SPF 50 ADVANCED FORMULA ULTRA SPORT SUNSCREEN AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 5; 6; 5; 10 g/100mL; g/100mL; 1/100mL; g/100mL; g/100mL N 20181231 61477-211_434dc135-c15d-4659-b09d-57ca52542eee 61477-211 HUMAN OTC DRUG ALOE UP PRO 50 CONTINUOUS SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.75; 4 g/100mL; g/100mL; g/100mL; g/100mL; 1/100mL N 20181231 61477-213_6c783b07-f206-4e61-87ef-28472af86147 61477-213 HUMAN OTC DRUG ALOE UP SUNSCREEN SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE LOTION TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTINOXATE; OCTOCRYLENE 3; 5; 5; 6; 10 g/100mL; g/100mL; g/100mL; g/100mL; 1/100mL N 20181231 61477-214_79ce1137-5081-4d95-a1db-e7888d0296fc 61477-214 HUMAN OTC DRUG ALOE UP NATURAL LIP ICE SUNSCREEN OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC OCTINOXATE; OXYBENZONE 2; 4.5 g/100g; 1/100g N 20181231 61477-215_abd00ab9-675a-4d0f-95cc-a2535d1221cc 61477-215 HUMAN OTC DRUG ALOE UP MEDICATED LIP BALM SPF 30 HOMOSALATE, MERADIMATE, OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC OCTINOXATE; HOMOSALATE; MERADIMATE; OXYBENZONE 7.5; 6; 4; 5 g/100g; 1/100g; 1/100g; 1/100g N 20181231 61477-216_0b9a4b5d-18a6-4454-9c4f-a0217a51775f 61477-216 HUMAN OTC DRUG ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN OCTINOXATE, OXYBENZONE SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part352 Aloe Care International, LLC OCTINOXATE; OXYBENZONE 2; 2 g/100mL; 1/100mL N 20181231 61480-105_5690f29b-eb68-49d2-8594-46ed7f4f0347 61480-105 HUMAN OTC DRUG PSORIASIS Niccolum Sulphuricum, Natrum Bromatum, Zincum Bromatum, Kali Bromatum, Kali Sulphuricum. LIQUID ORAL 20161212 UNAPPROVED HOMEOPATHIC PLYMOUTH HEALTHCARE PRODUCTS LLC NICKEL SULFATE HEXAHYDRATE; SODIUM BROMIDE; ZINC BROMIDE; POTASSIUM BROMIDE; POTASSIUM SULFATE 3; 2; 4; 1; 4 [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL; [hp_X]/237mL N 20181231 61480-124_3ed2138f-db38-4878-92b8-97b6d78f98e1 61480-124 HUMAN PRESCRIPTION DRUG Psorizide Ultra Potassium Bromide, Nickel Sulfate, and Zinc Bromide TABLET ORAL 19971001 UNAPPROVED HOMEOPATHIC PLYMOUTH HEALTHCARE PRODUCTS LLC POTASSIUM BROMIDE; NICKEL SULFATE; ZINC BROMIDE 1; 1; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] E 20171231 61480-125_fc190774-8bef-45cf-a058-d19347c46a73 61480-125 HUMAN OTC DRUG ECZEMA Niccolum Sulphuricum, Kali Bromatum, Kali Muriaticum, Hepar Sulphuris Calcareum, Kali Bichromicum, Kali Sulphuricum, Sulphur. TABLET, CHEWABLE ORAL 20160501 UNAPPROVED HOMEOPATHIC PLYMOUTH HEALTHCARE PRODUCTS LLC NICKEL SULFATE HEXAHYDRATE; POTASSIUM BROMIDE; POTASSIUM CHLORIDE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; POTASSIUM SULFATE; SULFUR 3; 1; 1; 3; 3; 3; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 61480-127_d8564f2e-5e43-45d9-96bd-e05196e4e891 61480-127 HUMAN PRESCRIPTION DRUG Eczemol Potassium Bromide, Nickel Sulfate, and Sulfur TABLET ORAL 20011115 UNAPPROVED HOMEOPATHIC PLYMOUTH HEALTHCARE PRODUCTS LLC POTASSIUM BROMIDE; NICKEL SULFATE; SULFUR 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 61480-137_c17d0ed5-7196-42e9-88d1-9c5026ecb98b 61480-137 HUMAN PRESCRIPTION DRUG Acunol Nickel Sulfate, Potassium Bromide, Sodium Bromide, Zinc Sulfate Anhydrous, and Sulfur TABLET ORAL 20060418 UNAPPROVED HOMEOPATHIC PLYMOUTH HEALTHCARE PRODUCTS LLC NICKEL SULFATE; POTASSIUM BROMIDE; SODIUM BROMIDE; ZINC SULFATE ANHYDROUS; SULFUR 1; 1; 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] E 20171231 61480-145_21e5823d-5a75-4e84-9978-aa96456685bb 61480-145 HUMAN OTC DRUG ACNE Niccolum Sulphuricum, Kali Bromatum, Zincum Oxydatum, Hepar Sulphuris Calcareum, Sulphur. TABLET, CHEWABLE ORAL 20160501 UNAPPROVED HOMEOPATHIC PLYMOUTH HEALTHCARE PRODUCTS LLC NICKEL SULFATE HEXAHYDRATE; POTASSIUM BROMIDE; ZINC OXIDE; CALCIUM SULFIDE; SULFUR 3; 1; 1; 3; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 61480-255_9e026510-c0d2-4ed4-9287-0b0aa5f0fc96 61480-255 HUMAN PRESCRIPTION DRUG Psorizide Forte Nickel Sulfate, Potassium Bromide, and Fumaric Acid TABLET ORAL 20011115 UNAPPROVED HOMEOPATHIC PLYMOUTH HEALTHCARE PRODUCTS LLC NICKEL SULFATE; POTASSIUM BROMIDE; FUMARIC ACID 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 61480-310_62221bbb-463c-4d4d-b2ba-39f91d75dc24 61480-310 HUMAN OTC DRUG DANDRUFF Kali Bromatum, Kali Muriaticum, Kali Sulphuricum, Natrum Muriaticum, Sulphur, Calcarea Carbonica, Niccolum Sulphuricum. TABLET ORAL 20170524 UNAPPROVED HOMEOPATHIC PLYMOUTH HEALTHCARE PRODUCTS LLC POTASSIUM BROMIDE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM CHLORIDE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; NICKEL SULFATE HEXAHYDRATE 1; 1; 1; 1; 1; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 61481-0020_4040fe2f-0096-44bc-9ce6-259612eeebfe 61481-0020 HUMAN OTC DRUG KINeSYS Analgesic Sport METHYL SALICYLATE and MENTHOL STICK TOPICAL 20120531 OTC MONOGRAPH NOT FINAL part348 KINeSYS Pharmaceutical Inc. METHYL SALICYLATE; MENTHOL 30; 15 g/100g; g/100g E 20171231 61481-0037_0285d3fa-c9c9-4bc8-9883-b6331066dec3 61481-0037 HUMAN OTC DRUG KINeSYS EarthKind SPF 30 Sunscreen ZINC OXIDE OINTMENT TOPICAL 20110201 OTC MONOGRAPH FINAL part352 KINeSYS Pharmaceutical Inc. ZINC OXIDE 250 g/1000g E 20171231 61481-0045_b79aab66-3716-4c7a-be5d-f2c1a1e689f3 61481-0045 HUMAN OTC DRUG KINESYS SPF 30 SOLID SUNSCREEN OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE STICK TOPICAL 20120620 OTC MONOGRAPH NOT FINAL part352 KINeSYS Pharmaceutical Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 4.5; 1 g/100g; g/100g; g/100g; g/100g E 20171231 61481-3001_bc1bd4ec-6b02-4ee3-86d7-1b55a7fec267 61481-3001 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 30 Alcohol-Free Performance Sunscreen - Fragrance Free OCTINOXATE, OCTOCRYLENE, OCTISALATE, and Avobenzone SPRAY TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Wilc Healthcare Inc OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 7.5; 7.5; 5; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61481-3002_a2d6ae73-4e4b-47c7-b018-b3a96dc92d7a 61481-3002 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 30 Kids Alcohol-Free Sunscreen OCTINOXATE, OCTOCRYLENE, OCTISALATE, and Avobenzone SPRAY TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Wilc Healthcare Inc OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 7.5; 7.5; 5; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61481-3003_2332fd35-cb8a-4750-8efd-696c04c1972b 61481-3003 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango Scent OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE SPRAY TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Wilc Healthcare Inc OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 7.5; 7.5; 5; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61481-3004_357d069b-73d6-4559-9cc8-153ad123ab16 61481-3004 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 30 Girl Alcohol-Free Sunscreen OCTINOXATE, OCTOCRYLENE, OCTISALATE, and Avobenzone SPRAY TOPICAL 20170605 OTC MONOGRAPH NOT FINAL part352 Wilc Healthcare Inc OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 7.5; 7.5; 5; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61481-3005_b27cbda8-7721-4deb-9a75-8eb347938166 61481-3005 HUMAN OTC DRUG Kinesys Broad Spectrum SPF 50 Alcohol Free Sunscreen Octocrylene, Octinoxate, Homosalate, Octisalate, and Avobenzone SPRAY TOPICAL 20150327 OTC MONOGRAPH NOT FINAL part352 Wilc Healthcare Inc OCTOCRYLENE; OCTINOXATE; HOMOSALATE; OCTISALATE; AVOBENZONE 100; 75; 75; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 61495-101_bc6f1ccc-a784-48a5-97bd-0e8ab8d7aaf2 61495-101 HUMAN OTC DRUG Cramp-Z Magnesia Muriatica SPRAY TOPICAL 20150101 UNAPPROVED HOMEOPATHIC MAGNESIUM DIRECT INC. MAGNESIUM CHLORIDE 1 [hp_X]/mL N 20181231 61495-401_bb010f87-cfad-4deb-b8d3-bcefdf4f58ac 61495-401 HUMAN OTC DRUG Fibro Flex Magnesia Muriatica SPRAY TOPICAL 20150711 UNAPPROVED HOMEOPATHIC MAGNESIUM DIRECT INC. MAGNESIUM CHLORIDE 1 [hp_X]/mL E 20171231 61500-0115_3ce3c874-c8e2-3d3f-e054-00144ff88e88 61500-0115 HUMAN OTC DRUG My Pain Away After Burn Cream Aesculus hippocastanum, Arnica montana, Belladonna, Crotalus horridus, Echinacea, Graphites, Heloderma, Lachesis mutus, Naja tripudians, Rhus toxicodendron, Ruta graveolens CREAM TOPICAL 20160801 UNAPPROVED HOMEOPATHIC Topical BioMedics, Inc. ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; BELLIS PERENNIS; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR; HYPERICUM PERFORATUM 6; 8; 6; 6; 6; 8; 8; 6; 6; 6; 12; 4; 8; 6 [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL N 20181231 61500-1501_2b070b9f-f50f-278e-e054-00144ff8d46c 61500-1501 HUMAN OTC DRUG MyPainAway Sports Cream Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Calendula Officinalis, Capsicum Annum, Crotalus Horridus, Echinacea, Gelsemium Sempervirens, Graphites, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Magnesium Phosphorica, Naja Tripudians, Rhus Tox, Ruta Graveolens, Sulphur CREAM TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Topical BioMedics, Inc. AESCULUS HIPPOCASTANUM BARK; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS WHOLE; SULFUR; CAPSICUM ANNUUM WHOLE; CROTALUS HORRIDUS HORRIDUS WHOLE; ECHINACEA, UNSPECIFIED; GRAPHITE; GELSEMIUM SEMPERVIRENS WHOLE; HYPERICUM PERFORATUM; LACHESIS MUTA WHOLE; POTASSIUM CARBONATE; MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED; NAJA NAJA WHOLE; RHUS SPP. WHOLE; RUTA GRAVEOLENS WHOLE 6; 6; 6; 6; 8; 10; 8; 6; 6; 8; 6; 8; 8; 6; 8; 12; 6 [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X] N 20181231 61500-5527_30c6ff5a-fbec-45c4-e054-00144ff88e88 61500-5527 HUMAN OTC DRUG Topricin Aesculus hippocastanum, Arnica montana, Belladonna, Crotalus horridus, Echinacea, Graphites, Heloderma, Lachesis mutus, Naja tripudians, Rhus toxicodendron, Ruta graveolens CREAM TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Topical BioMedics, Inc. AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF 6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6 [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g N 20181231 61500-5547_321e83de-71ef-20b4-e054-00144ff8d46c 61500-5547 HUMAN OTC DRUG Topricin aesculus hippocastanum, arnica montana, belladonna, calendula officinalis, crotalus horridus, echinacea, graphites, heloderma horridum, lachesis mutus, naja tripudians, phosphorus, rhus toxicodendron, ruta graveolens, sulfur CREAM TOPICAL 20160518 UNAPPROVED HOMEOPATHIC Topical BioMedics, Inc. PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR 9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8 [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g N 20181231 61500-5587_e77e7b72-847e-48df-93cc-3e20bdd234dd 61500-5587 HUMAN OTC DRUG My Pain Away Aesculus hippocastanum, Arnica montana, Belladonna, Crotalus horridus, Echinacea, Graphites, Heloderma, Lachesis mutus, Naja tripudians, Rhus toxicodendron, Ruta graveolens CREAM TOPICAL 20141001 UNAPPROVED HOMEOPATHIC Topical BioMedics, Inc. AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; ATROPA BELLADONNA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 6; 6; 8; 6; 6; 8; 8; 8; 6; 6 [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL N 20181231 61502-903_2a555b67-c70a-0c8f-e054-00144ff8d46c 61502-903 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET ORAL 20160127 ANDA ANDA088627 EPM Packaging Inc ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 61502-908_2a53c7e4-c519-4714-e054-00144ff88e88 61502-908 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20160127 ANDA ANDA040746 EPM Packaging Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 61502-913_2a57a1ee-da48-0595-e054-00144ff8d46c 61502-913 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20160127 ANDA ANDA040736 EPM Packaging Inc ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 61502-914_2a584f52-f947-5d95-e054-00144ff88e88 61502-914 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20160127 ANDA ANDA040656 EPM Packaging Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 61502-915_2a67aa02-3ef4-0ef8-e054-00144ff88e88 61502-915 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN TABLET ORAL 20160128 ANDA ANDA040778 EPM Packaging Inc OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 61502-922_2a52224e-60c6-6204-e054-00144ff8d46c 61502-922 HUMAN PRESCRIPTION DRUG PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE TABLET ORAL 20160126 ANDA ANDA091042 EPM Packaging Inc PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 61504-000_37906041-267e-42d6-947a-f4ee52cb50bb 61504-000 HUMAN OTC DRUG Iris Antimicrobial Hand CHLOROXYLENOL SOAP TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333A Amerifoods Trading Company CHLOROXYLENOL 3 mg/mL N 20181231 61504-001_ae6cc4b7-ea7d-42b8-b84b-26efd4134e82 61504-001 HUMAN OTC DRUG Iris Antimicrobial Hand CHLOROXYLENOL SOAP TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333A Amerifoods Trading Company CHLOROXYLENOL 3 mg/mL N 20181231 61504-002_107f938c-d831-46aa-bcfe-19e5c2465c61 61504-002 HUMAN OTC DRUG First Street Dishwasing Concentrate and Antimicrobial Hand CHLOROXYLENOL SOAP TOPICAL 20131218 OTC MONOGRAPH NOT FINAL part333A Amerifoods Trading Company CHLOROXYLENOL 3 mg/mL N 20181231 61504-033_8a5ab2fd-3ee0-4e72-b949-2ad820a5d4f9 61504-033 HUMAN OTC DRUG IRIS HYDROGEN PEROXIDE LIQUID TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A AMERIFOODS TRADING COMPANY HYDROGEN PEROXIDE 3 g/100g N 20181231 61504-140_9cce1579-f1b9-47d8-8068-56646a3197ea 61504-140 HUMAN OTC DRUG Iris Hand Sanitizing Wipes Alcohol CLOTH TOPICAL 20160131 OTC MONOGRAPH NOT FINAL part333E Amerifoods Trading Company ALCOHOL; ALOE VERA LEAF; ALPHA-TOCOPHEROL ACETATE 62; .01; .01 g/100g; g/100g; g/100g N 20181231 61504-810_34e765f4-ecb1-4db1-bb8e-26a177faddfc 61504-810 HUMAN OTC DRUG IRIS ISOPROPYL ALCOHOL LIQUID TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A AMERIFOODS TRADING COMPANY ISOPROPYL ALCOHOL 500 mg/mL N 20181231 61504-871_69c5fc36-0a13-4fb6-9fb6-de7e61472463 61504-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20170209 OTC MONOGRAPH NOT FINAL part333A Amerifoods Trading Co HYDROGEN PEROXIDE 30 mg/mL N 20181231 61508-0163_487f6aa0-be7e-39f8-e054-00144ff88e88 61508-0163 HUMAN OTC DRUG 60 Second Gel Bubblegum Fluoride gel GEL, DENTIFRICE DENTAL 20170224 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM FLUORIDE 1.69 g/100g N 20181231 61508-0165_487f6aa0-be7e-39f8-e054-00144ff88e88 61508-0165 HUMAN OTC DRUG 60 Second Gel Grape Fluoride gel GEL, DENTIFRICE DENTAL 20170224 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM FLUORIDE 1.69 g/100g N 20181231 61508-0166_487f6aa0-be7e-39f8-e054-00144ff88e88 61508-0166 HUMAN OTC DRUG 60 Second Gel Mint Fluoride gel GEL, DENTIFRICE DENTAL 20170224 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM FLUORIDE 1.69 g/100g N 20181231 61508-0167_487f6aa0-be7e-39f8-e054-00144ff88e88 61508-0167 HUMAN OTC DRUG 60 Second Gel Orange Cream Fluoride gel GEL, DENTIFRICE DENTAL 20170224 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM FLUORIDE 1.69 g/100g N 20181231 61508-0169_487f6aa0-be7e-39f8-e054-00144ff88e88 61508-0169 HUMAN OTC DRUG 60 Second Gel Strawberry Fluoride gel GEL, DENTIFRICE DENTAL 20170224 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM FLUORIDE 1.69 g/100g N 20181231 61508-0176_477fc92b-e607-480f-e054-00144ff8d46c 61508-0176 HUMAN OTC DRUG Gel 7 Neutral Topical Fluoride Gel Mint Fluoride Gel GEL, DENTIFRICE DENTAL 20170203 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM FLUORIDE 2 g/100g N 20181231 61508-0179_477fc92b-e607-480f-e054-00144ff8d46c 61508-0179 HUMAN OTC DRUG Gel 7 Neutral Topical Fluoride Gel Strawberry Fluoride Gel GEL, DENTIFRICE DENTAL 20170203 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM FLUORIDE 2 g/100g N 20181231 61508-0200_51d8d5bd-babb-44c3-e054-00144ff88e88 61508-0200 HUMAN OTC DRUG OroMin calcium chloride, sodium fluoride, sodium phosphate RINSE DENTAL 20170616 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM PHOSPHATE, MONOBASIC; CALCIUM CHLORIDE; SODIUM FLUORIDE .056; .054; .01 g/100g; g/100g; g/100g N 20181231 61508-0201_51dccfdb-a9c9-1d4f-e054-00144ff8d46c 61508-0201 HUMAN OTC DRUG Zip Topical Anesthetic Gel Mint Benzocaine GEL DENTAL 20170616 UNAPPROVED DRUG OTHER Germiphene Corporation BENZOCAINE 20 g/100g N 20181231 61508-0202_51ed1882-c2d9-0b19-e054-00144ff88e88 61508-0202 HUMAN OTC DRUG Zip Topical Anesthetic Gel Strawberry Benzocaine GEL DENTAL 20170616 UNAPPROVED DRUG OTHER Germiphene Corporation BENZOCAINE 20 g/100g N 20181231 61508-0370_47a06f42-3145-354e-e054-00144ff8d46c 61508-0370 HUMAN OTC DRUG Neutragel Sodium fluoride GEL, DENTIFRICE DENTAL 20170206 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM FLUORIDE 1.1 g/100g N 20181231 61508-0526_47a16b3b-4a8c-6446-e054-00144ff8d46c 61508-0526 HUMAN OTC DRUG Neutrarinse 2% Neutral Sodium Floride Oral Rinse RefreshMint Sodium Fluoride RINSE DENTAL 20170206 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM FLUORIDE 2 g/100g N 20181231 61508-0527_47a16b3b-4a8c-6446-e054-00144ff8d46c 61508-0527 HUMAN OTC DRUG Neutrarinse 2% Neutral Sodium Floride Oral Rinse White Grape Sodium Fluoride RINSE DENTAL 20170206 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM FLUORIDE 2 g/100g N 20181231 61508-0528_47a16b3b-4a8c-6446-e054-00144ff8d46c 61508-0528 HUMAN OTC DRUG Neutrarinse 2% Neutral Sodium Floride Oral Rinse Raspberry Splash Sodium Fluoride RINSE DENTAL 20170206 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM FLUORIDE 2 g/100g N 20181231 61508-1120_4fb91ca4-deaa-4dc6-e054-00144ff88e88 61508-1120 HUMAN OTC DRUG Floam Topical Floam Fluoride Sodium Fluoride AEROSOL, FOAM DENTAL 20170206 UNAPPROVED DRUG OTHER Germiphene Corporation SODIUM FLUORIDE 1.732 g/100g N 20181231 61509-101_2b48f7bc-39a0-424a-ba51-22393fe54894 61509-101 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140228 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g E 20171231 61509-102_a716a174-6697-4419-a050-4f5e3bc32f70 61509-102 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140228 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g E 20171231 61509-103_eb5d685a-0193-452f-98c0-c0061b87219b 61509-103 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140228 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g E 20171231 61509-104_7a0b280c-71fb-4924-b522-f3db6db92696 61509-104 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140303 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g E 20171231 61509-105_db52a040-49e8-442a-9120-bf79f3fb6c92 61509-105 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140303 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g E 20171231 61509-106_329f3a09-1ad7-4237-bf75-8135aee85b30 61509-106 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140303 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g E 20171231 61509-107_b10b96b7-934b-4dae-8913-6b5fdfb83a77 61509-107 HUMAN OTC DRUG Mark 3 Benzocaine Gel GEL DENTAL; ORAL 20140303 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g E 20171231 61509-108_067ed54e-7092-407e-a3f8-14f126480325 61509-108 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20120303 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g E 20171231 61509-109_52a942d1-9198-44c2-aae9-e79af55857ff 61509-109 HUMAN OTC DRUG Mark 3 Benzocaine GEL DENTAL; ORAL 20140303 OTC MONOGRAPH NOT FINAL part356 Cargus International, Inc. BENZOCAINE 6.4 g/32g E 20171231 61515-101_ed09b1ed-d0ef-4135-9db6-dc57e0d46ab7 61515-101 HUMAN OTC DRUG UNIQUE NATURAL PREMIUM SHEA BUTTER SHEA BUTTER CREAM TOPICAL 20131229 UNAPPROVED HOMEOPATHIC NATURAL COSMETICS INDUSTRY LTD SHEA BUTTER 99.5 g/100g E 20171231 61515-103_03045514-54b2-45b3-9833-c1e45ba795c7 61515-103 HUMAN OTC DRUG UNIQUE NATURAL PREMIUM SHEA BUTTER Fragrance-Free SHEA BUTTER CREAM TOPICAL 20131229 UNAPPROVED HOMEOPATHIC NATURAL COSMETICS INDUSTRY LTD SHEA BUTTER 99.5 g/100g E 20171231 61519-001_4de47c52-9e79-461f-be46-56109d55b395 61519-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20131231 UNAPPROVED MEDICAL GAS Shasta Medical Equipment OXYGEN 99 L/100L E 20171231 61520-001_4924d35f-58e0-4b07-857e-75e50b46e92e 61520-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20131227 UNAPPROVED MEDICAL GAS Premier Medical Distribution OXYGEN 99 L/100L E 20171231 61526-1001_63bcb496-4dda-4cb7-b8c0-b5fab0e50217 61526-1001 HUMAN OTC DRUG SoonSoo gargle SODIUM FLUORIDE MOUTHWASH DENTAL 20131116 OTC MONOGRAPH FINAL part355 Chang Hwa Dang Co., Ltd. SODIUM FLUORIDE .02 g/100mL E 20171231 61531-100_2096ffe7-27ec-244f-e054-00144ff8d46c 61531-100 HUMAN OTC DRUG Surf Bay Lip Balm Lip Balm GEL TOPICAL 20150925 OTC MONOGRAPH FINAL part352 Universal Packaging Systems, Inc. DBA: PakLab OCTINOXATE .075 g/g E 20171231 61531-101_230c795d-a0fb-636e-e054-00144ff8d46c 61531-101 HUMAN OTC DRUG Acne Serum Skin Restoring Acne Serum GEL TOPICAL 20151026 OTC MONOGRAPH FINAL part333D Universal Packaging Systems, Inc. DBA: Paklab SALICYLIC ACID .01 g/g E 20171231 61531-102_24b37b91-784c-0eae-e054-00144ff8d46c 61531-102 HUMAN OTC DRUG Coral Bay Juicy Lip Fix SPF45 Coral Bay STICK TOPICAL 20151116 OTC MONOGRAPH FINAL part352 Universal Packaging Systems, Inc. DBA: PakLab HOMOSALATE; OCTOCRYLENE; OCTINOXATE; AVOBENZONE .1; .03; .075; .03 g/g; g/g; g/g; g/g E 20171231 61531-103_2552a16c-ea58-64a3-e054-00144ff8d46c 61531-103 HUMAN OTC DRUG Cosmedix SPF50 Sunscreen EMULSION TOPICAL 20151124 OTC MONOGRAPH FINAL part352 Universal Packaging Systems, Inc. DBA: PakLab OXYBENZONE; OCTINOXATE; AVOBENZONE; OCTISALATE .05; .075; .03; .05 g/g; g/g; g/g; g/g E 20171231 61543-1082_2d9d1d62-843e-4bbe-be62-cdd8fcb3bb0a 61543-1082 HUMAN OTC DRUG Sudden Change Intensive Restoration Daily Moisturizer SPF 15 ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20110918 OTC MONOGRAPH FINAL part352 CCA Industries Inc ZINC OXIDE; OCTINOXATE 2; 6 mL/100mL; mL/100mL N 20181231 61543-1601_0c154433-23ac-4183-a32b-720ce3921b17 61543-1601 HUMAN OTC DRUG Bikini Zone Medicated CREME LIDOCAINE CREAM TOPICAL 20100603 OTC MONOGRAPH FINAL part333B CCA Industries, Inc. LIDOCAINE 2 g/100g N 20181231 61543-1604_73d387ba-069c-42fd-9620-7677c45cb477 61543-1604 HUMAN OTC DRUG Bikini Zone Medicated LIDOCAINE GEL TOPICAL 20100604 OTC MONOGRAPH FINAL part333B CCA Industries, Inc. LIDOCAINE 2 g/100g N 20181231 61543-1613_a92d757b-07d4-4c46-87dc-f280ef335811 61543-1613 HUMAN OTC DRUG Bikini Zone Medicated CREME LIDOCAINE CREAM TOPICAL 20100604 OTC MONOGRAPH FINAL part333B CCA Industries, Inc. LIDOCAINE 2 g/100g N 20181231 61543-1644_d7a8421d-9772-45f6-a152-06e5c7f99fec 61543-1644 HUMAN OTC DRUG Bikini Zone MEDICATED After Shave Fresh Scent PRAMOXINE HYDROCHLORIDE SPRAY TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 CCA Industries, Inc. PRAMOXINE HYDROCHLORIDE 10 mg/mL N 20181231 61543-1774_5a9fe880-c83b-4ec5-88f4-05ca309310cf 61543-1774 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN SPORT BROAD SPECTRUM SPF 50 Plus OCTISALATE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20130807 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTISALATE; OCTINOXATE; ZINC OXIDE 5; 7.5; 14.5 g/100g; g/100g; g/100g N 20181231 61543-2285_76ab6950-f507-43f9-bcc4-7b314a349a7f 61543-2285 HUMAN OTC DRUG Nutra Nail FUNGI FREE Antifungal Treatment UNDECYLENIC ACID LIQUID TOPICAL 20140813 OTC MONOGRAPH FINAL part333C CCA Industries, Inc UNDECYLENIC ACID 250 mg/mL E 20171231 61543-3130_802a5cac-e074-4c77-87f8-2daecce25b85 61543-3130 HUMAN OTC DRUG PAIN BUST R II MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20111223 OTC MONOGRAPH FINAL part348 CCA Industries, Inc. MENTHOL; METHYL SALICYLATE 12; 18 g/100g; g/100g N 20181231 61543-6087_cea60fd8-bc82-4af0-b8d0-769b5f13d61f 61543-6087 HUMAN OTC DRUG Scar Zone Topical Scar Diminishing DIMETHICONE, ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20100614 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. DIMETHICONE; ZINC OXIDE; OCTINOXATE 4; 4; 7.5 g/100g; g/100g; g/100g N 20181231 61543-6168_3d7c7855-6830-4659-bc66-a18415c7356e 61543-6168 HUMAN OTC DRUG SCAR ZONE ACNE SALICYLIC ACID CREAM TOPICAL 20100614 OTC MONOGRAPH FINAL part333D CCA Industries, Inc. SALICYLIC ACID 2 g/100g N 20181231 61543-6169_c871f6db-0b7a-4e2f-a34b-85d17ce1a67a 61543-6169 HUMAN OTC DRUG Scar Zone Burn Extra Strength Burn Relief Topical Analgesic and Antiseptic LIDOCAINE, BENZALKONIUM CHLORIDE GEL TOPICAL 20100701 OTC MONOGRAPH FINAL part333B CCA Industries, Inc. LIDOCAINE; BENZALKONIUM CHLORIDE 2; .13 g/100g; g/100g N 20181231 61543-6174_e5943078-ebf4-4244-b804-1584b7473308 61543-6174 HUMAN OTC DRUG Scar Zone Burn Topical Analgesic and Antiseptic LIDOCAINE, BENZALKONIUM CHLORIDE GEL TOPICAL 20100614 OTC MONOGRAPH FINAL part333B CCA Industries, Inc. LIDOCAINE; BENZALKONIUM CHLORIDE 2; .13 g/100g; g/100g N 20181231 61543-7224_101ae850-aaea-4b80-8bae-4d6708467165 61543-7224 HUMAN OTC DRUG Plus White Coffee Drinkers Whitening SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100612 OTC MONOGRAPH FINAL part333 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .884 g/100g N 20181231 61543-7233_e459ca3e-c961-482e-96f6-8efa2f456a22 61543-7233 HUMAN OTC DRUG Plus White With Peroxide SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100609 OTC MONOGRAPH FINAL part333 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .884 g/100g N 20181231 61543-7236_d83a1080-d5c8-4db2-bf8f-cfa1174d222f 61543-7236 HUMAN OTC DRUG Plus Plus White Smokers Whitening SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100611 OTC MONOGRAPH FINAL part333 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .884 g/100g N 20181231 61543-7237_e88a1553-7d5e-45a1-ad0f-5a3105eef9c0 61543-7237 HUMAN OTC DRUG Plus White Xtra SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100611 OTC MONOGRAPH FINAL part333 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .884 g/100g N 20181231 61543-7240_1f608fa2-3df3-4fb9-87bd-c13e1db6e613 61543-7240 HUMAN OTC DRUG Plus White Super White TOOTH with PEROXIDE SODIUM MONOFLUOROPHOSPHATE PASTE ORAL 20130801 OTC MONOGRAPH FINAL part355 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .884 g/100g N 20181231 61543-7243_4ae6080b-6a3f-436a-9166-91609029c66b 61543-7243 HUMAN OTC DRUG Plus White Xtra Whitening SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100611 OTC MONOGRAPH FINAL part333 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE .884 g/100g N 20181231 61543-7254_0d7575a7-43a9-4703-b1ea-966373171d04 61543-7254 HUMAN OTC DRUG Plus White Plus EVERY DAY WHITENING SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20130801 OTC MONOGRAPH FINAL part355 CCA Industries, Inc. SODIUM MONOFLUOROPHOSPHATE 1.14 g/100g N 20181231 61543-7501_62221ffb-8494-4cc0-9bbd-3c9e0bd09e93 61543-7501 HUMAN OTC DRUG HAND PERFECTION ANTI-AGING SKINCARE nourishing day SPF 15 ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. ZINC OXIDE; OCTINOXATE 20; 60 mg/mL; mg/mL N 20181231 61543-7755_1aca8da3-4ccf-4920-8782-8eef08398bf8 61543-7755 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN FACE and BODY SPORT BROAD SPECTRUM SPF 50 Plus OCTISALATE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. OCTISALATE; OCTINOXATE; ZINC OXIDE 50; 75; 145 mg/mL; mg/mL; mg/mL N 20181231 61543-7770_0fc0df6d-f0d5-47ca-86e9-019ff4829228 61543-7770 HUMAN OTC DRUG Solar Sense Sun Damage Restoration Body SPF 15 ZINC OXIDE, OCTINOXATE LOTION TOPICAL 20101002 OTC MONOGRAPH FINAL part352 CCA Industries, Inc ZINC OXIDE; OCTINOXATE 2; 6 mL/100mL; mL/100mL N 20181231 61543-7772_b5caae08-4724-49fd-a7dc-d188cbe137a2 61543-7772 HUMAN OTC DRUG Solar Sense Clear Zinc Body SPF 50 AVOBENZONE, OCTINOXATE, ZINC OXIDE, OCTOCRYLENE STICK TOPICAL 20101004 OTC MONOGRAPH FINAL part352 CCA Industries, Inc AVOBENZONE; OCTINOXATE; ZINC OXIDE; OCTOCRYLENE 3; 7.5; 8; 9 g/100g; g/100g; g/100g; g/100g N 20181231 61543-7774_6e7f47f6-98af-4db0-9a24-c0ed0858827c 61543-7774 HUMAN OTC DRUG Solar Sense Clear Zinc Sport Body SPF 50 AVOBENZONE, OCTINOXATE, ZINC OXIDE, OCTOCRYLENE STICK TOPICAL 20101005 OTC MONOGRAPH FINAL part352 CCA Industries, Inc AVOBENZONE; OCTINOXATE; ZINC OXIDE; OCTOCRYLENE 3; 7.5; 8; 9 g/41g; g/100g; g/100g; g/100g N 20181231 61543-7782_6a16c1c9-6514-403f-9a75-28cebfee19fa 61543-7782 HUMAN OTC DRUG Solar Sense Zany Zinc SPF 50 - Pink ZINC OXIDE CREAM TOPICAL 20101004 OTC MONOGRAPH FINAL part352 CCA Industries, Inc ZINC OXIDE 25 g/100g N 20181231 61543-7943_4e73b5d8-8ce2-4555-92c8-ab115ea10606 61543-7943 HUMAN OTC DRUG SOLAR SENSE CLEAR ZINC SUNSCREEN VALUE PACK 50 PLUS OCTISALATE, OCTINOXATE, ZINC OXIDE KIT 20130807 OTC MONOGRAPH NOT FINAL part352 CCA Industries, Inc. N 20181231 61547-101_42750f45-adf0-4860-b20e-4f3bd9cdab77 61547-101 HUMAN OTC DRUG CALIFORNIA NATUREL LIP BALM SPF 8 TITANIUM DIOXIDE AND ZINC OXIDE LIPSTICK TOPICAL 20140114 OTC MONOGRAPH FINAL part352 CALIFORNIA NATUREL TITANIUM DIOXIDE; ZINC OXIDE 1.8; 2 g/100g; g/100g E 20171231 61551-0101_281d1187-b0e5-41ae-90a9-8334644d293c 61551-0101 HUMAN OTC DRUG GINSENG KIANPI PIL GINSENG KIANPI CAPSULE ORAL 20140107 UNAPPROVED HOMEOPATHIC Guangzhou HanWindBeauty Commerce Co.,Ltd ANGELICA SINENSIS WHOLE; MORINDA OFFICINALIS WHOLE; PANAX GINSENG ROOT OIL 20; 22; 28 mg/g; mg/g; mg/g E 20171231 61554-232_4adc17fa-8f94-3d4e-e054-00144ff88e88 61554-232 HUMAN OTC DRUG Shield and Protect Anti-Fungal Anti-Fungal Skin Protectant CREAM TOPICAL 20070101 UNAPPROVED DRUG OTHER Gentell, Inc. CLOTRIMAZOLE 1.1 g/115g N 20181231 61554-234_4b58519d-055e-0b28-e054-00144ff8d46c 61554-234 HUMAN OTC DRUG Zinc Oxide Zinc Oxide Ointment CREAM TOPICAL 20141103 UNAPPROVED DRUG OTHER Gentell, Inc,. ZINC OXIDE .2 kg/kg N 20181231 61558-100_2bd9fc8a-42c4-4461-bfef-d1aa2e26d2c9 61558-100 HUMAN OTC DRUG Eron Healing Tonic Zinc Pyrithione SHAMPOO TOPICAL 20131230 UNAPPROVED DRUG OTHER GS-TK Co., Ltd PYRITHIONE ZINC; PANTHENOL 3; 2.5 g/500mL; g/500mL E 20171231 61561-003_308335e3-71b6-4dd9-8495-d02b28b4caa6 61561-003 HUMAN OTC DRUG ZIMS MAX ARNICA HOMEOPATHIC ALOE VERA LEAF, ARNICA MONTANA, CALENDULA OFFICINALIS FLOWER, and BELLIS PERENNIS GEL TOPICAL 20150701 UNAPPROVED HOMEOPATHIC PERFECTA PRODUCTS, INC ALOE VERA LEAF; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWER; BELLIS PERENNIS 3; 1; 3; 4 [hp_X]/3mL; [hp_X]/3mL; [hp_X]/3mL; [hp_X]/3mL E 20171231 61561-012_2602045d-539c-4da5-a6a6-26a969c32b91 61561-012 HUMAN OTC DRUG ZIMS ADVANCED COLD SORE AND FEVER BLISTER MOISTURIZING PROTECTANT WITH PURIFIED PROPOLIS PETROLATUM KIT 20140115 OTC MONOGRAPH FINAL part347 PERFECTA PRODUCTS, INC. N 20191231 61566-105_f3451004-6453-4692-98ff-f47657485109 61566-105 HUMAN OTC DRUG Burn Relief Professional Kool-Down Lidocaine - 4% CREAM TOPICAL 20130115 20200205 OTC MONOGRAPH NOT FINAL part348 Kool-Down Inc. LIDOCAINE 4 g/100g N 20181231 61566-107_5f484486-ac29-4d38-8e13-038401b3a7c6 61566-107 HUMAN OTC DRUG Burn Relief Extra Strength Kool-Down Lidocaine - 3.9% CREAM TOPICAL 20130415 20180803 OTC MONOGRAPH NOT FINAL part348 Kool-Down Inc. LIDOCAINE 3.9 g/100mL N 20191231 61567-001_f49a5794-ab2d-4194-be93-5311adf7acc5 61567-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19940101 NDA NDA205849 Ali-Rob, Inc. dba Southern Oxygen & Welding Supply OXYGEN 990 mL/L N 20181231 61570-024_eef51cdb-7214-4c23-8cfc-6ad41eca14ef 61570-024 HUMAN PRESCRIPTION DRUG THALITONE chlorthalidone TABLET ORAL 19881220 NDA NDA019574 Monarch Pharmaceuticals, Inc CHLORTHALIDONE 15 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 61570-031_6ed2319b-ed87-4def-adea-660e6fee7780 61570-031 HUMAN PRESCRIPTION DRUG CORTISPORIN neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone OINTMENT TOPICAL 19550415 NDA NDA050168 Pfizer Laboratories Div Pfizer Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE 3.5; 5000; 400; 10 mg/g; [iU]/g; [iU]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61570-032_79927d9a-3f90-4115-8f88-48a1e9a388ca 61570-032 HUMAN PRESCRIPTION DRUG CORTISPORIN neomycin sulfate, polymyxin B sulfate, and hydrocortisone acetate CREAM TOPICAL 19630610 NDA NDA050218 Pfizer Laboratories Div Pfizer Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE ACETATE 3.5; 10000; 5 mg/g; [iU]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61570-037_a88dbf48-f9e1-4dd6-95af-714e932190bc 61570-037 HUMAN PRESCRIPTION DRUG VIROPTIC trifluridine SOLUTION OPHTHALMIC 19800410 NDA NDA018299 Pfizer Laboratories Div Pfizer Inc TRIFLURIDINE 1 g/100mL Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC],Nucleoside Metabolic Inhibitor [EPC],Nucleic Acid Synthesis Inhibitors [MoA] N 20181231 61570-045_79ed55ea-a425-4311-92e5-ec07175059e1 61570-045 HUMAN PRESCRIPTION DRUG NEOSPORIN neomycin and polymyxin B sulfates and gramicidin SOLUTION OPHTHALMIC 19550411 ANDA ANDA060582 Pfizer Laboratories Div Pfizer Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN 1.75; 10000; .025 mg/mL; [iU]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 61570-047_4dbac744-2320-4e4b-b4a2-15a8c177f42d 61570-047 HUMAN PRESCRIPTION DRUG NEOSPORIN G.U. neomycin sulfate - polymyxin B sulfate IRRIGANT IRRIGATION 19660628 ANDA ANDA060707 Pfizer Laboratories Div Pfizer Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE 40; 200000 mg/mL; [iU]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 61570-048_4dbac744-2320-4e4b-b4a2-15a8c177f42d 61570-048 HUMAN PRESCRIPTION DRUG NEOSPORIN G.U. neomycin sulfate - polymyxin B sulfate IRRIGANT IRRIGATION 19660628 ANDA ANDA060707 Pfizer Laboratories Div Pfizer Inc NEOMYCIN SULFATE; POLYMYXIN B SULFATE 40; 200000 mg/mL; [iU]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 61570-072_b279d1d2-43e7-4080-bb13-50aae861d484 61570-072 HUMAN PRESCRIPTION DRUG MENEST esterified estrogens TABLET, FILM COATED ORAL 19770928 ANDA ANDA084951 Pfizer Laboratories Div Pfizer Inc ESTROGENS, ESTERIFIED .3 mg/1 N 20181231 61570-073_b279d1d2-43e7-4080-bb13-50aae861d484 61570-073 HUMAN PRESCRIPTION DRUG MENEST esterified estrogens TABLET, FILM COATED ORAL 19770928 ANDA ANDA084948 Pfizer Laboratories Div Pfizer Inc ESTROGENS, ESTERIFIED .625 mg/1 N 20181231 61570-074_b279d1d2-43e7-4080-bb13-50aae861d484 61570-074 HUMAN PRESCRIPTION DRUG MENEST esterified estrogens TABLET, FILM COATED ORAL 19770928 ANDA ANDA084950 Pfizer Laboratories Div Pfizer Inc ESTROGENS, ESTERIFIED 1.25 mg/1 N 20181231 61570-079_860abf51-8d26-4b94-9d6d-00364af77556 61570-079 HUMAN PRESCRIPTION DRUG TIGAN trimethobenzamide hydrochloride CAPSULE ORAL 20011213 NDA NDA017531 Pfizer Laboratories Div Pfizer Inc TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 61570-102_3806ba4f-660c-45f1-9065-90d0a68fb23e 61570-102 HUMAN PRESCRIPTION DRUG Tussigon hydrocodone bitartrate and homatropine methylbromide TABLET ORAL 19850730 ANDA ANDA088508 Pfizer Laboratories Div Pfizer Inc HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 61570-110_15516862-2de9-47d8-b385-4d3ff77fb4de 61570-110 HUMAN PRESCRIPTION DRUG ALTACE ramipril CAPSULE ORAL 19910128 NDA NDA019901 Pfizer Laboratories Div Pfizer Inc RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61570-111_15516862-2de9-47d8-b385-4d3ff77fb4de 61570-111 HUMAN PRESCRIPTION DRUG ALTACE ramipril CAPSULE ORAL 19910128 NDA NDA019901 Pfizer Laboratories Div Pfizer Inc RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61570-112_15516862-2de9-47d8-b385-4d3ff77fb4de 61570-112 HUMAN PRESCRIPTION DRUG ALTACE ramipril CAPSULE ORAL 19910128 NDA NDA019901 Pfizer Laboratories Div Pfizer Inc RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61570-120_15516862-2de9-47d8-b385-4d3ff77fb4de 61570-120 HUMAN PRESCRIPTION DRUG ALTACE ramipril CAPSULE ORAL 19910128 NDA NDA019901 Pfizer Laboratories Div Pfizer Inc RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61570-131_df4ef6d6-4036-4ea7-908d-9fcd95681f2c 61570-131 HUMAN PRESCRIPTION DRUG SILVADENE silver sulfadiazine CREAM TOPICAL 19731126 NDA NDA017381 Pfizer Laboratories Div Pfizer Inc SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 61570-260_a6d6774c-4d1c-4016-b69e-7dcf54518519 61570-260 HUMAN PRESCRIPTION DRUG Synercid quinupristin and dalfopristin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19990921 NDA NDA050748 Pfizer Laboratories Div Pfizer Inc QUINUPRISTIN; DALFOPRISTIN 150; 350 mg/5mL; mg/5mL Streptogramin Antibacterial [EPC],Streptogramins [Chemical/Ingredient],Streptogramin Antibacterial [EPC],Streptogramins [Chemical/Ingredient] N 20181231 61577-2280_b1681331-f711-4438-b2c1-614ca19abcab 61577-2280 HUMAN OTC DRUG SORE NO MORE MENTHOL CAMPHOR GEL TOPICAL 20161025 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL; CAMPHOR (SYNTHETIC) .03; .03 g/g; g/g N 20181231 61577-2301_21b2f6cb-3727-4f34-880d-553d6ef8cf3a 61577-2301 HUMAN OTC DRUG MUSCLE EASE MENTHOL CAMPHOR GEL TOPICAL 20111216 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL; CAMPHOR (SYNTHETIC) .03; .03 g/g; g/g N 20181231 61577-3216_a21e63e3-888d-40ce-80c9-ae85a6d82b91 61577-3216 HUMAN OTC DRUG SOMBRA WARM THERAPY MENTHOL CAMPHOR GEL TOPICAL 20160613 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL; CAMPHOR (SYNTHETIC) .03; .03 g/g; g/g N 20181231 61577-3221_443a475e-c42d-45a1-9e93-013b9519e519 61577-3221 HUMAN OTC DRUG SOMBRA COOL THERAPY MENTHOL GEL TOPICAL 20160429 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL .06 g/g N 20181231 61577-3234_616b95b1-02eb-2a78-e053-2a91aa0a2ff5 61577-3234 HUMAN OTC DRUG SORE NO MORE WARM THERAPY MENTHOL and CAMPHOR GEL TOPICAL 20160613 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL; CAMPHOR (SYNTHETIC) .03; .03 g/g; g/g N 20181231 61577-3235_616b9363-5db0-a913-e053-2991aa0a2477 61577-3235 HUMAN OTC DRUG SORE NO MORE COOL THERAPY MENTHOL GEL TOPICAL 20160614 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL .06 g/g N 20181231 61577-3242_f26f79a1-c2ee-4536-befc-e4c308a66cae 61577-3242 HUMAN OTC DRUG RE-LEVE MENTHOL GEL TOPICAL 20161005 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL .06 g/g N 20181231 61577-3610_1fb514f2-a819-4350-94c5-d1606b4bbe5f 61577-3610 HUMAN OTC DRUG DEEP REMEDY MENTHOL CAMPHOR GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL; CAMPHOR (SYNTHETIC) .03; .03 g/g; g/g N 20181231 61577-3710_81b81277-b098-46ec-8201-a8b7bd8eb0a0 61577-3710 HUMAN OTC DRUG THERAID MENTHOL GEL TOPICAL 20130220 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL .04 g/g N 20181231 61577-4020_616a0b42-4f99-5064-e053-2a91aa0a7163 61577-4020 HUMAN OTC DRUG SOMBRA WARM THERAPY MENTHOL CAMPHOR GEL TOPICAL 20160613 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL; CAMPHOR (SYNTHETIC) .03; .03 g/g; g/g N 20181231 61577-4030_616a9712-77f7-55f5-e053-2991aa0a46e9 61577-4030 HUMAN OTC DRUG SOMBRA COOL THERAPY MENTHOL GEL TOPICAL 20171020 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL .06 g/g N 20181231 61577-4040_6169bf1d-4904-728d-e053-2991aa0ae410 61577-4040 HUMAN OTC DRUG SORE NO MORE WARM THERAPY MENTHOL and CAMPHOR GEL TOPICAL 20160613 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL; CAMPHOR (SYNTHETIC) .03; .03 g/g; g/g N 20181231 61577-4050_6169bf1d-4911-728d-e053-2991aa0ae410 61577-4050 HUMAN OTC DRUG SORE NO MORE COOL THERAPY MENTHOL GEL TOPICAL 20170605 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL .06 g/g N 20181231 61577-4080_616af9fa-dfd4-dd03-e053-2a91aa0a2fb2 61577-4080 HUMAN OTC DRUG HealQu Warm Therapy Gel MENTHOL CAMPHOR GEL TOPICAL 20170702 OTC MONOGRAPH NOT FINAL part348 SOMBRA COSMETICS INC. MENTHOL; CAMPHOR (SYNTHETIC) .03; .03 g/g; g/g N 20181231 61578-203_44cbd3db-47a6-4030-a1c0-851a8494516b 61578-203 HUMAN OTC DRUG CTx4 Gel 1100 Mint sodium fluoride GEL, DENTIFRICE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 1100 ug/g E 20171231 61578-204_44cbd3db-47a6-4030-a1c0-851a8494516b 61578-204 HUMAN OTC DRUG CTx4 Gel 1100 Citrus sodium fluoride GEL, DENTIFRICE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 1100 ug/g E 20171231 61578-205_08101317-6b6b-4243-8e77-19f151f4b856 61578-205 HUMAN PRESCRIPTION DRUG CTx4 Gel 5000 Mint Sodium fluoride GEL, DENTIFRICE DENTAL 20120501 UNAPPROVED DRUG OTHER Oral BioTech SODIUM FLUORIDE 5000 ug/g E 20171231 61578-206_08101317-6b6b-4243-8e77-19f151f4b856 61578-206 HUMAN PRESCRIPTION DRUG CTx4 Gel 5000 Citrus Sodium fluoride GEL, DENTIFRICE DENTAL 20120501 UNAPPROVED DRUG OTHER Oral BioTech SODIUM FLUORIDE 5000 ug/g E 20171231 61578-207_44cbd3db-47a6-4030-a1c0-851a8494516b 61578-207 HUMAN OTC DRUG CTx4 Gel 1100 Grape sodium fluoride GEL, DENTIFRICE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 1100 ug/g E 20171231 61578-301_16ba2e79-b217-44b5-b228-76507e06eb12 61578-301 HUMAN OTC DRUG CTx3 Rinse Mint Anticaries RINSE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 226 ug/mL E 20171231 61578-302_16ba2e79-b217-44b5-b228-76507e06eb12 61578-302 HUMAN OTC DRUG CTx3 Rinse Citrus Anticaries RINSE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 226 ug/mL E 20171231 61578-303_16ba2e79-b217-44b5-b228-76507e06eb12 61578-303 HUMAN OTC DRUG CTx3 Rinse Grape Anticaries RINSE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 226 ug/mL E 20171231 61578-304_cbfdbbf7-06fb-418f-8e5e-35847dfb3e5c 61578-304 HUMAN OTC DRUG CTx4 Rinse Mint Anticaries RINSE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 226 ug/mL E 20171231 61578-305_cbfdbbf7-06fb-418f-8e5e-35847dfb3e5c 61578-305 HUMAN OTC DRUG CTx4 Rinse Apple Anticaries RINSE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Oral BioTech SODIUM FLUORIDE 226 ug/mL E 20171231 61579-001_1f813477-467e-4d05-a213-9db4e0227b71 61579-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140102 UNAPPROVED MEDICAL GAS Advantage Home Medical LLC OXYGEN 99 L/100L E 20171231 61582-532_d04904d2-471a-49b1-ac42-e4719b448760 61582-532 HUMAN OTC DRUG Natures Sunshine Products Everflex Topical Analgesic Pain Relief Menthol CREAM TOPICAL 20100813 OTC MONOGRAPH NOT FINAL part348 Natures Sunshine Products, Inc. MENTHOL 1.25 g/100g N 20181231 61587-1001_0cf10c77-4e5e-49fd-8234-3d8d7aca5144 61587-1001 HUMAN OTC DRUG Hwang Geum-San Gold Hair GLYCERIN SHAMPOO TOPICAL 20140114 OTC MONOGRAPH FINAL part347 Hwang Geum-San Co., Ltd GLYCERIN .2 g/100mL E 20171231 61589-0011_e6ee3bb6-3b6d-448c-9187-eb6c183b2162 61589-0011 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Mocha No. 64 OCTINOXATE CREAM TOPICAL 20141217 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 70 mg/mL N 20181231 61589-1812_b5300a64-7d13-42dd-bbea-ddc2341f8169 61589-1812 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 New Ivory 10 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-1814_332fecb0-3324-4f4a-9cd7-e2e68efc1e75 61589-1814 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Blonde 20 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-1815_a7dd249a-39b3-454c-958e-5894d49eab1b 61589-1815 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Vanilla 25 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-1816_27246973-b990-421d-8807-dfed6faa4191 61589-1816 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Almond 30 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-1818_cb5f2d61-7589-4161-9db3-409e6d92ec00 61589-1818 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Truffle 50 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-1821_f902e754-2994-4826-b545-b2bb744de2ad 61589-1821 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 05 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-1822_0ba8684b-529b-4e2d-a0aa-16c6d665dd6f 61589-1822 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Buff 15 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-1823_ad3656f8-bcb4-4423-8278-0a984b464a38 61589-1823 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Suede 40 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-1824_13ff2832-4e25-472c-89a6-c30e5548e7a5 61589-1824 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Espresso 45 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-1825_c5cb4bdb-a6d2-4d09-9171-90b19a9588f7 61589-1825 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Tan 35 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-1826_6b230cd9-f67f-4687-9003-3a72012f9425 61589-1826 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Cocoa 55 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-1827_a9599c2c-34fa-40f9-ac33-35eac58e2f3b 61589-1827 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Mocha 60 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-1828_23780a39-e376-4100-a542-01be78b15fd3 61589-1828 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Toffee Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1829_dcbeba0e-415b-48da-9c67-937a5f9610c8 61589-1829 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 chestnut Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1830_10cad642-dfff-4b81-86d0-7023229f06f8 61589-1830 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Latte Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1831_09736543-9df6-4571-81ab-f7319674974a 61589-1831 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Wheat Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1832_238af64c-22e7-4e44-87dd-b76f71401719 61589-1832 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Honey Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1833_f7624f52-7215-45a8-9d9c-8b544b9dae34 61589-1833 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1834_739643e8-c83e-49f1-b9fb-c8db772f7ada 61589-1834 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1835_35994b90-5e9c-497f-ae4c-e1b06902abe6 61589-1835 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Warm Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1836_b3f70535-1fcd-45ce-bdbe-68dc0c25a948 61589-1836 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1837_ed0a5db5-b2fb-43d3-8a36-60dab17ec033 61589-1837 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Warm Ivory Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1838_d5169fd2-a4a4-4bdb-88bf-682de4d26631 61589-1838 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1839_4c41dadd-2668-4541-a128-ff72d23dc5ac 61589-1839 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Calico Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1840_e70f6fcf-a489-43ec-bbed-a4d03f121679 61589-1840 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Ebony Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g E 20171231 61589-1841_753a6564-03ef-4e84-907c-ac8df6e3bdbf 61589-1841 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1842_bb28deaf-ff93-458a-9368-f1db39235202 61589-1842 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Chestnut Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1843_cc7637d2-3bb1-4c9d-a4b4-1f06d0441df2 61589-1843 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1844_b9f70e0c-f69f-47af-a7b4-b5c0ecfbcca6 61589-1844 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1845_999ceef5-bed5-4240-932a-88411cf1fe0f 61589-1845 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1846_846f68ee-6a5b-4a51-b8f3-0a0ce869e8a9 61589-1846 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1847_4af39ecd-4ca6-4405-8b26-b69f7d0a8398 61589-1847 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1848_bc678439-0fa5-4635-b4af-6e7056f1b1fe 61589-1848 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1849_4c9c88a3-1dc8-4805-9c10-604a38c1976d 61589-1849 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1850_55512e7b-6aad-4008-9153-2427a21b48f5 61589-1850 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1851_4bfdb5ef-399e-47f2-8180-9263fb7e344f 61589-1851 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1852_49e419f4-0dc1-40a5-af4e-483972944a0a 61589-1852 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1853_1e3e65dd-5663-4ea2-83de-a8cc353308ed 61589-1853 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1854_ee5c09f0-4f33-4bc9-a00e-d8935301432c 61589-1854 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1855_44e9983e-5fe5-4be4-946c-91eff6e01b02 61589-1855 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1856_01804154-ccf6-4f92-8b07-0601cf42bac9 61589-1856 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1857_43e8e7f1-07a1-46d0-9d61-e35cf8646c07 61589-1857 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-1904_c690ab88-f687-4d83-a2b4-39b493a2ba25 61589-1904 HUMAN OTC DRUG No7 Soft and Sheer Tinted Moisturiser Fair Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100305 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 2.5; .95 mL/50mL; mL/50mL E 20171231 61589-1905_4939ae99-6e9f-4b63-adc6-2bec3a92151b 61589-1905 HUMAN OTC DRUG No7 Soft and Sheer Tinted Moisturiser Medium Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100305 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 2.5; .95 mL/50mL; mL/50mL E 20171231 61589-1906_5a503b63-1188-4db9-9048-b4db76afef21 61589-1906 HUMAN OTC DRUG No7 Soft and Sheer Tinted Moisturiser Dark Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100305 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 2.5; .95 mL/50mL; mL/50mL E 20171231 61589-1911_8e7da61d-980e-4ce5-8045-63042d082f3b 61589-1911 HUMAN OTC DRUG No7 Dual Action Tinted Moisturiser Fair Avobenzone, Octisalate and Octocrylene EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g N 20181231 61589-1913_1bde3af8-7033-409c-ac45-9fe483edbb60 61589-1913 HUMAN OTC DRUG No7 Dual Action Tinted Moisturiser Medium Avobenzone, Octisalate and Octocrylene EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g N 20181231 61589-1921_15507bd7-996a-4333-8526-ffab9dcfa3fd 61589-1921 HUMAN OTC DRUG No7 City Light Tinted Moisturiser Sunscreen Broad Spectrum SPF 15 Fair Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20161214 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g N 20181231 61589-1922_94bb81a0-f27a-48c8-9a12-7118341e39df 61589-1922 HUMAN OTC DRUG No7 City Light Tinted Moisturiser Sunscreen Broad Spectrum SPF 15 Medium Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20161214 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g N 20181231 61589-1923_c8a63eb6-adb9-41e0-9ff9-e8721ba89f6e 61589-1923 HUMAN OTC DRUG No7 City Light Tinted Moisturiser Sunscreen Broad Spectrum SPF 15 Medium Dark Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20161214 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g N 20181231 61589-3809_036c560a-afd1-4359-abad-31360e3e3567 61589-3809 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Porcelain 05 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-3810_b88dba89-ab5a-4b34-bf1c-0e67dfd89db3 61589-3810 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 New Ivory 10 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-3811_6b21248a-a6cb-479c-95a9-298064adc0ea 61589-3811 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Nude 15 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-3812_da8c195b-1c14-470a-b8b4-fdece2c4ba85 61589-3812 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Blonde 20 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100111 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-3813_31eae540-a8e7-4d6a-b0d3-7210de3e1260 61589-3813 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Vanilla 25 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-3814_0168867a-226f-49c2-9656-3b27ae331ef6 61589-3814 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Almond 35 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100111 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-3815_c65a35f1-a552-4e51-aa18-ef6d6c801e7b 61589-3815 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Walnut 45 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-3816_617cd224-404e-45a6-ab6d-7d5b8a99da2d 61589-3816 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Truffle 50 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 61589-5311_04b12455-a1b4-42e0-be9a-60f60c9d069c 61589-5311 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Ebony OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g E 20171231 61589-5312_4045d682-5c6f-4a5d-be6b-2393e9465f07 61589-5312 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g E 20171231 61589-5313_f5e6e012-6ebb-4ef2-a3f5-eb8402b71ace 61589-5313 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Calico OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g E 20171231 61589-5314_07d79035-b32d-4598-bfa2-4a0344a34b20 61589-5314 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Mocha OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g E 20171231 61589-5315_90770e5a-a0f9-4df9-b094-d01ce590bdd8 61589-5315 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Honey OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g E 20171231 61589-5316_b9dbab00-7637-4aac-82e6-d9a7dc2541ba 61589-5316 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Wheat OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g E 20171231 61589-5317_23d2636f-4eb1-4390-87ac-a35cb793f644 61589-5317 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g E 20171231 61589-5318_afb9d54b-d5c2-4be7-bd14-29183d3a81c6 61589-5318 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g E 20171231 61589-5319_2a5c0dbf-06ee-4d3f-813c-6734af8fa130 61589-5319 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 1.5 g/30g E 20171231 61589-6001_ce0bff73-2eba-42b3-9ac7-d56b6851a498 61589-6001 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Ebony Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g E 20171231 61589-6002_81312aef-014f-4987-a95b-fbef246e81db 61589-6002 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Mocha Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g E 20171231 61589-6003_9ee7afa4-a1bb-450a-8482-8397776b611c 61589-6003 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Wheat Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g N 20181231 61589-6004_50a08ba8-60c2-4260-83c1-c1959599a758 61589-6004 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g N 20181231 61589-6005_6e3ef9b9-a7ae-4f61-9150-57afefc65216 61589-6005 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g N 20181231 61589-6006_a7527907-4d3d-43f8-90dc-b9e1c1b6b10c 61589-6006 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g N 20181231 61589-6007_a24b0a1b-5389-487e-8336-eeea62744fe2 61589-6007 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g N 20181231 61589-6008_a8ed0087-da06-4694-9299-a6e61ad14741 61589-6008 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Calico Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 2.25 g/30g E 20171231 61589-6009_8a881a35-0fd3-4f32-97c1-2d4a308c7e6e 61589-6009 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Deeply Honey Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-6010_bcc5ea07-9a1b-4bfc-878f-22d83063fda4 61589-6010 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Honey Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-6011_30b754aa-7c12-4eae-a33b-6528d249451e 61589-6011 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Warm Beige Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-6012_808d16dd-5a11-43e0-82c3-305a4016e18e 61589-6012 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Chestnut Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-6013_4e608985-150d-4a8f-a6d6-a63352e1bf08 61589-6013 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Hazelnut Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g E 20171231 61589-6014_37d761da-b067-44f3-8bfa-0e501714d3f8 61589-6014 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Warm Sand Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g E 20171231 61589-6015_e969bbf3-0665-4a43-8996-fe871363838e 61589-6015 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Warm Ivory Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-6016_16014b26-8d42-4417-a6df-66cb4305b6de 61589-6016 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Toffee Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-6017_b36cef6d-26b7-40a7-a96b-f744623c7381 61589-6017 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Honey Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-6018_a402b7a7-09cb-4571-a19a-e44650ea2038 61589-6018 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Latte Octinoxate CREAM TOPICAL 20140103 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE 7.5 g/30g N 20181231 61589-6502_ecf9e85d-9a69-4adb-a57f-494b380f306a 61589-6502 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Mocha Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g E 20171231 61589-6503_3f0fd100-d3b7-4760-846e-d4e46fd9b584 61589-6503 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Wheat Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g N 20181231 61589-6504_ef96b4f3-d413-4680-8bce-4ed515ce4c83 61589-6504 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g N 20181231 61589-6505_eda7db2c-c4c5-4f32-8ba3-7320c4fb6883 61589-6505 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g N 20181231 61589-6506_55f1c013-3cb2-4ed6-a39d-e63392126056 61589-6506 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g N 20181231 61589-6507_17424102-088d-4e8a-b3a9-4debacec1c9f 61589-6507 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g N 20181231 61589-8101_9e17ab4b-ed8c-468c-a962-b21b0faa2c68 61589-8101 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Calico Octinoxate CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20181231 61589-8102_5672b83a-b047-4276-8476-17947bc8b928 61589-8102 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla Octinoxate CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20181231 61589-8103_e9d0615b-1bbe-4020-a399-731c09b21ee8 61589-8103 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Warm Ivory Octinoxate CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20181231 61589-8104_62f2a9d0-b7eb-4419-813d-0579d8be773e 61589-8104 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory Octinoxate CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20181231 61589-8105_902df8e2-7994-480b-99ff-3887789c8a9e 61589-8105 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige Octinoxate CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20181231 61589-8106_5284441f-f23b-4fa2-9f7a-b4e56d2ce202 61589-8106 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Warm Beige Octinoxate CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20181231 61589-8107_816ebb94-895a-4d96-93a6-508a62f071a3 61589-8107 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20181231 61589-8108_d11b89c7-c1d9-46a5-bb40-5e54e5997524 61589-8108 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Honey Octinoxate CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20181231 61589-8109_d2dba63c-1de9-4ff9-aae0-44bc71b71bfc 61589-8109 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Wheat Octinoxate CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20181231 61589-8110_f1705a03-3d4f-41ae-bade-57ec3aefa56b 61589-8110 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Latte Octinoxate CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20181231 61589-8111_8d233af7-1b5f-4ace-9307-f52b26f9452a 61589-8111 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Chestnut Octinoxate CREAM TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20181231 61589-9501_7d890a77-841a-4e5a-a5f9-ac5873059448 61589-9501 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Calico Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20181231 61589-9502_69cc345e-f2ff-462c-9cf4-032dd9c6b39e 61589-9502 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20191231 61589-9503_f678936a-4b7a-4f16-bf3b-095b6176c723 61589-9503 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Ivory Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20191231 61589-9504_8339388a-187b-48e2-b2be-995dec98c836 61589-9504 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20191231 61589-9505_69d6cb17-d099-41c0-82f9-08b8dc202c7a 61589-9505 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Beige Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20191231 61589-9506_90219062-3646-45b8-9213-85e7003ead31 61589-9506 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Beige Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20191231 61589-9507_5d83c816-fa09-40bc-b3dd-d03f38ce4ba8 61589-9507 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deep Beige Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20191231 61589-9508_2756fac1-9a71-4289-80ed-bd2fa2f0a371 61589-9508 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Wheat Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20191231 61589-9509_bd6736cc-b647-43c2-acda-f13c12a48a1c 61589-9509 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Deep Honey Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20191231 61589-9510_164b4a36-5872-4fde-be71-2711d9237dc5 61589-9510 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Honey Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20191231 61589-9511_287f8491-881c-4f4f-8890-2910f8dd3d0a 61589-9511 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Honey Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20191231 61589-9512_7e905975-23c0-4af5-ac65-bcf06a474900 61589-9512 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Latte Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20191231 61589-9513_26ba275a-3749-4afd-9893-eff7ddedee2b 61589-9513 HUMAN OTC DRUG No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Toffee Octinoxate CREAM TOPICAL 20180121 OTC MONOGRAPH NOT FINAL part352 BCM Cosmetique SAS OCTINOXATE; TITANIUM DIOXIDE 1.5; .5 g/30g; g/30g N 20191231 61594-000_ba10d804-11bd-4e40-b5b4-869b68acd98b 61594-000 HUMAN OTC DRUG Theraworx pre-moistened cloths ALLANTOIN LIQUID TOPICAL 20140313 OTC MONOGRAPH FINAL part347 Avadim Technologies, Inc. ALLANTOIN .5 g/100g N 20181231 61594-001_6d9b3b30-342d-4ad1-aa1c-b11431be86e5 61594-001 HUMAN OTC DRUG Theraworx Patented Foam Formulation ALLANTOIN LIQUID TOPICAL 20140109 OTC MONOGRAPH FINAL part347 Avadim Technologies, Inc. ALLANTOIN 5 mg/mL N 20181231 61594-003_60e25b7e-0742-5dfb-e053-2a91aa0a5035 61594-003 HUMAN OTC DRUG Theraworx Relief Muscle Cramp and Spasm Relief MAGNESIUM SULFATE HEPTAHYDRATE AEROSOL, FOAM TOPICAL 20170722 UNAPPROVED HOMEOPATHIC Avadim Technologies, Inc MAGNESIUM SULFATE HEPTAHYDRATE 6 [hp_X]/210mL N 20181231 61594-004_60e263af-08ca-87b1-e053-2991aa0a0f60 61594-004 HUMAN OTC DRUG Theraworx Relief Muscle Cramp and Spasm Relief MAGNESIUM SULFATE HEPTAHYDRATE SPRAY, METERED TOPICAL 20170722 UNAPPROVED HOMEOPATHIC Avadim Technologies, Inc MAGNESIUM SULFATE HEPTAHYDRATE 6 [hp_X]/210mL N 20181231 61596-437_4d63020f-934d-2af4-e054-00144ff8d46c 61596-437 HUMAN OTC DRUG MIPaste ONE sodium fluoride, potassium nitrate PASTE, DENTIFRICE DENTAL 20170703 OTC MONOGRAPH NOT FINAL part356 GC America Inc. SODIUM FLUORIDE; POTASSIUM NITRATE .0024; .06 g/g; g/g N 20181231 61596-880_1ea3d2f1-6269-1090-e054-00144ff88e88 61596-880 HUMAN OTC DRUG MIPaste Plus sodium fluoride PASTE, DENTIFRICE DENTAL 20150601 OTC MONOGRAPH FINAL part355 GC America Inc. SODIUM FLUORIDE 2 g/.2g E 20171231 61596-882_1ea3d2f1-6269-1090-e054-00144ff88e88 61596-882 HUMAN OTC DRUG MIPaste Plus sodium fluoride PASTE, DENTIFRICE DENTAL 20150601 OTC MONOGRAPH FINAL part355 GC America Inc. SODIUM FLUORIDE 2 g/.2g E 20171231 61596-884_1ea3d2f1-6269-1090-e054-00144ff88e88 61596-884 HUMAN OTC DRUG MIPaste Plus sodium fluoride PASTE, DENTIFRICE DENTAL 20150601 OTC MONOGRAPH FINAL part355 GC America Inc. SODIUM FLUORIDE 2 g/.2g E 20171231 61596-888_1ea3d2f1-6269-1090-e054-00144ff88e88 61596-888 HUMAN OTC DRUG MIPaste Plus sodium fluoride PASTE, DENTIFRICE DENTAL 20150601 OTC MONOGRAPH FINAL part355 GC America Inc. SODIUM FLUORIDE 2 g/.2g E 20171231 61596-986_1ea3d2f1-6269-1090-e054-00144ff88e88 61596-986 HUMAN OTC DRUG MIPaste Plus Strawberry sodium fluoride PASTE, DENTIFRICE DENTAL 20150601 OTC MONOGRAPH FINAL part355 GC America Inc. SODIUM FLUORIDE 2 g/.2g E 20171231 61598-200_85a3bbaf-f55a-4c7a-aac8-07e9572f393e 61598-200 HUMAN OTC DRUG VeraSeptine Multipurpose Moisture Barrier Zinc Oxide CREAM TOPICAL 20131007 OTC MONOGRAPH FINAL part347 LTC Products, Inc. ZINC OXIDE 21 g/100g E 20171231 61601-0079_0b9892bb-a399-4596-8598-3a847ff185d1 61601-0079 HUMAN OTC DRUG LIPSTICK QUEEN ENDLESS SUMMER Broad Spectrum SPF 15 Sunscreen Homosalate, Octinoxate, Avobenzone and Octocrylene LIPSTICK TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited HOMOSALATE; OCTINOXATE; AVOBENZONE; OCTOCRYLENE .35; .14; .105; .07 g/3.5g; g/3.5g; g/3.5g; g/3.5g E 20171231 61601-0080_0b9892bb-a399-4596-8598-3a847ff185d1 61601-0080 HUMAN OTC DRUG LIPSTICK QUEEN ENDLESS SUMMER Broad Spectrum SPF 15 Sunscreen Homosalate, Octinoxate, Avobenzone and Octocrylene LIPSTICK TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited HOMOSALATE; OCTINOXATE; AVOBENZONE; OCTOCRYLENE .35; .14; .105; .07 g/3.5g; g/3.5g; g/3.5g; g/3.5g E 20171231 61601-0081_0b9892bb-a399-4596-8598-3a847ff185d1 61601-0081 HUMAN OTC DRUG LIPSTICK QUEEN ENDLESS SUMMER Broad Spectrum SPF 15 Sunscreen Homosalate, Octinoxate, Avobenzone and Octocrylene LIPSTICK TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited HOMOSALATE; OCTINOXATE; AVOBENZONE; OCTOCRYLENE .35; .14; .105; .07 g/3.5g; g/3.5g; g/3.5g; g/3.5g E 20171231 61601-0082_0b9892bb-a399-4596-8598-3a847ff185d1 61601-0082 HUMAN OTC DRUG LIPSTICK QUEEN ENDLESS SUMMER Broad Spectrum SPF 15 Sunscreen Homosalate, Octinoxate, Avobenzone and Octocrylene LIPSTICK TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited HOMOSALATE; OCTINOXATE; AVOBENZONE; OCTOCRYLENE .35; .14; .105; .07 g/3.5g; g/3.5g; g/3.5g; g/3.5g E 20171231 61601-1112_80586845-def2-462f-928d-21eead404fdf 61601-1112 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1113_80586845-def2-462f-928d-21eead404fdf 61601-1113 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1114_80586845-def2-462f-928d-21eead404fdf 61601-1114 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1115_80586845-def2-462f-928d-21eead404fdf 61601-1115 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1116_80586845-def2-462f-928d-21eead404fdf 61601-1116 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1117_80586845-def2-462f-928d-21eead404fdf 61601-1117 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1118_80586845-def2-462f-928d-21eead404fdf 61601-1118 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1119_80586845-def2-462f-928d-21eead404fdf 61601-1119 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1120_80586845-def2-462f-928d-21eead404fdf 61601-1120 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1121_80586845-def2-462f-928d-21eead404fdf 61601-1121 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1122_80586845-def2-462f-928d-21eead404fdf 61601-1122 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1123_80586845-def2-462f-928d-21eead404fdf 61601-1123 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1124_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1124 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1125_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1125 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1126_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1126 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1127_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1127 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1128_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1128 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1129_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1129 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1130_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1130 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1131_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1131 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1132_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1132 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1133_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1133 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1134_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1134 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1135_76fceaaf-713a-4125-a60b-7da5522f068c 61601-1135 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1136_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1136 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1137_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1137 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1138_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1138 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1139_0799bfca-4ae5-4bc5-a12c-da0d392c25bf 61601-1139 HUMAN OTC DRUG Eve Lom Brilliant Cover Concealer Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE .08; .078 g/2g; g/2g E 20171231 61601-1140_0799bfca-4ae5-4bc5-a12c-da0d392c25bf 61601-1140 HUMAN OTC DRUG Eve Lom Brilliant Cover Concealer Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE .08; .078 g/2g; g/2g E 20171231 61601-1141_0799bfca-4ae5-4bc5-a12c-da0d392c25bf 61601-1141 HUMAN OTC DRUG Eve Lom Brilliant Cover Concealer Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE .08; .078 g/2g; g/2g E 20171231 61601-1142_0799bfca-4ae5-4bc5-a12c-da0d392c25bf 61601-1142 HUMAN OTC DRUG Eve Lom Brilliant Cover Concealer Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE .08; .078 g/2g; g/2g E 20171231 61601-1143_0799bfca-4ae5-4bc5-a12c-da0d392c25bf 61601-1143 HUMAN OTC DRUG Eve Lom Brilliant Cover Concealer Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE .08; .078 g/2g; g/2g E 20171231 61601-1144_0799bfca-4ae5-4bc5-a12c-da0d392c25bf 61601-1144 HUMAN OTC DRUG Eve Lom Brilliant Cover Concealer Broad Spectrum SPF 15 Sunscreen Titanium Dioxide and Octinoxate CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE .08; .078 g/2g; g/2g E 20171231 61601-1175_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1175 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1176_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1176 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1177_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1177 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1181_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1181 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1182_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1182 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1183_5c82af10-57dd-4bb2-9681-6f65511f6d6b 61601-1183 HUMAN OTC DRUG Eve Lom Radiance Lift Foundation SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 1.38; 1.5 g/30mL; g/30mL E 20171231 61601-1193_0bd5c5a1-06bc-4318-a363-3a1fc6cf980b 61601-1193 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1194_0bd5c5a1-06bc-4318-a363-3a1fc6cf980b 61601-1194 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1195_0bd5c5a1-06bc-4318-a363-3a1fc6cf980b 61601-1195 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1196_0bd5c5a1-06bc-4318-a363-3a1fc6cf980b 61601-1196 HUMAN OTC DRUG Eve Lom Radiance Perfected Tinted Moisturiser SPF 15 Titanium Dioxide and Octinoxate CREAM TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited TITANIUM DIOXIDE; OCTINOXATE 3.1; 2.5 g/50mL; g/50mL E 20171231 61601-1217_a8421133-f2e7-42d2-add8-fd5d3ab03d90 61601-1217 HUMAN OTC DRUG Eve Lom Daily Protection Broad Spectrum SPF 50 Sunscreen Homosalate, Octisalate, Oxybenzone, Avobenzone, Octinoxate and Octocrylene CREAM TOPICAL 20140602 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTINOXATE; OCTOCRYLENE .5; .25; .25; .15; .15; .135 g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL N 20181231 61601-1233_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1233 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE .55; .55; .52; .35 g/10g; g/10g; g/10g; g/10g E 20171231 61601-1234_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1234 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE .55; .55; .52; .35 g/10g; g/10g; g/10g; g/10g E 20171231 61601-1235_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1235 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE .55; .55; .52; .35 g/10g; g/10g; g/10g; g/10g E 20171231 61601-1236_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1236 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE .55; .55; .52; .35 g/10g; g/10g; g/10g; g/10g E 20171231 61601-1237_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1237 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE .55; .55; .52; .35 g/10g; g/10g; g/10g; g/10g E 20171231 61601-1238_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1238 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE .55; .55; .52; .35 g/10g; g/10g; g/10g; g/10g E 20171231 61601-1239_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1239 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE .55; .55; .52; .35 g/10g; g/10g; g/10g; g/10g E 20171231 61601-1240_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1240 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE .55; .55; .52; .35 g/10g; g/10g; g/10g; g/10g E 20171231 61601-1241_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1241 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE .55; .55; .52; .35 g/10g; g/10g; g/10g; g/10g E 20171231 61601-1242_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1242 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE .55; .55; .52; .35 g/10g; g/10g; g/10g; g/10g E 20171231 61601-1243_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1243 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE .55; .55; .52; .35 g/10g; g/10g; g/10g; g/10g E 20171231 61601-1244_59037ea2-cab0-4789-bdb3-bda18350005a 61601-1244 HUMAN OTC DRUG Eve Lom Radiant Glow Cream Foundation Broad Spectrum SPF 30 Sunscreen Octinoxate, Octocrylene, Titanium Dioxide and Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE .55; .55; .52; .35 g/10g; g/10g; g/10g; g/10g E 20171231 61601-1250_ea3bb52a-c7c8-4a26-836c-8c23baf318c6 61601-1250 HUMAN OTC DRUG Eve Lom Flawless Radiance Primer Broad Spectrum SPF 30 Sunscreen Octinoxate, Octisalate, Octocrylene, Oxybenzone and Avobenzone LOTION TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Space Brands Limited OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 3.35; 2.25; 2.25; 1.5; 1.35 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL E 20171231 61604-9068_705ea49a-ae96-49d2-8ecf-58c74546bee9 61604-9068 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19930101 NDA NDA206023 Premier Medical Corporation OXYGEN 99 L/100L N 20191231 61611-107_931eb823-d3a6-4e19-a77a-033472467541 61611-107 HUMAN OTC DRUG SUB-ZERO COOL PAIN RELIEVING MENTHOL GEL TOPICAL 20131229 OTC MONOGRAPH NOT FINAL part348 CURRENT SOLUTIONS LLC MENTHOL 3.9 g/100mL E 20171231 61616-010_c833fe61-b2e4-4839-accb-d87406287edf 61616-010 HUMAN OTC DRUG Four Season PYRITHIONE ZINC SHAMPOO TOPICAL 20131201 OTC MONOGRAPH FINAL part358H OneLineSun Co., Ltd. PYRITHIONE ZINC 1.8 mg/300mL E 20171231 61616-020_6245b26c-02a7-44b7-af56-985fd2805e53 61616-020 HUMAN OTC DRUG Four Season Essence Salicylic acid LIQUID TOPICAL 20131201 OTC MONOGRAPH FINAL part358H OneLineSun Co., Ltd. SALICYLIC ACID 2.16 mg/120mL E 20171231 61619-717_3036c141-e236-6519-e054-00144ff88e88 61619-717 HUMAN OTC DRUG Antisepation Benzethonium Chloride LOTION CUTANEOUS 20160205 OTC MONOGRAPH NOT FINAL part333E A-Cute Derm, Incorporated BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 61619-718_228d0fc2-16c8-2b16-e054-00144ff88e88 61619-718 HUMAN OTC DRUG ANTIMICROBIAL FOAMING SANITIZER Benzethonium chloride liquid LIQUID TOPICAL 20151027 OTC MONOGRAPH NOT FINAL part333A A-Cute Derm, Incorporated BENZETHONIUM CHLORIDE .2 g/100g E 20171231 61619-718_228e0849-e91a-4c83-e054-00144ff88e88 61619-718 HUMAN OTC DRUG ANTIMICROBIAL FOAMING SANITIZER Benzethonium chloride liquid LIQUID TOPICAL 20151027 OTC MONOGRAPH NOT FINAL part333A A-Cute Derm, Incorporated BENZETHONIUM CHLORIDE .2 g/100g E 20171231 61619-718_228e3c11-613f-5535-e054-00144ff88e88 61619-718 HUMAN OTC DRUG ANTIMICROBIAL FOAMING SANITIZER Benzethonium chloride liquid LIQUID TOPICAL 20151027 OTC MONOGRAPH NOT FINAL part333A A-Cute Derm, Incorporated BENZETHONIUM CHLORIDE .2 g/100g E 20171231 61619-864_2a7f6935-a74d-7130-e054-00144ff8d46c 61619-864 HUMAN OTC DRUG Pro-Tect Sports Sunscreen SPF 20 Meradimate, Octinoxate, Octisalate, Oxybenzone LOTION CUTANEOUS 20160205 OTC MONOGRAPH NOT FINAL part352 A-Cute Derm, Incorporated OCTINOXATE; MERADIMATE; OXYBENZONE; OCTISALATE 75; 50; 30; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 61619-866_2abbf728-649f-02a4-e054-00144ff8d46c 61619-866 HUMAN OTC DRUG Pro-Tect Sunscreen for Professionals Meradimate, Octinoxate, Octisalate, Oxybenzone LOTION CUTANEOUS 20160208 OTC MONOGRAPH NOT FINAL part352 A-Cute Derm, Incorporated OCTINOXATE; MERADIMATE; OXYBENZONE; OCTISALATE 75; 50; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 61619-868_232cc4ca-790c-2e81-e054-00144ff88e88 61619-868 HUMAN OTC DRUG PRO-TECT EVERYDAY SUNSCREEN SPF 15 Octinoxate, Octisalate, Padimate O LOTION TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part352 A-Cute Derm, Incorporated OCTINOXATE; OXYBENZONE; PADIMATE O 75; 20; 50 mg/g; mg/g; mg/g N 20181231 61619-868_232cf535-42d7-2749-e054-00144ff8d46c 61619-868 HUMAN OTC DRUG PRO-TECT EVERYDAY SUNSCREEN SPF 15 Octinoxate, Octisalate, Padimate O LOTION TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part352 A-Cute Derm, Incorporated OCTINOXATE; OXYBENZONE; PADIMATE O 75; 20; 50 mg/g; mg/g; mg/g N 20181231 61619-868_232d224f-cb55-3a9c-e054-00144ff88e88 61619-868 HUMAN OTC DRUG PRO-TECT EVERYDAY SUNSCREEN SPF 15 Octinoxate, Octisalate, Padimate O LOTION TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part352 A-Cute Derm, Incorporated OCTINOXATE; OXYBENZONE; PADIMATE O 75; 20; 50 mg/g; mg/g; mg/g N 20181231 61619-868_232d4805-ccba-3f6e-e054-00144ff88e88 61619-868 HUMAN OTC DRUG PRO-TECT EVERYDAY SUNSCREEN SPF 15 Octinoxate, Octisalate, Padimate O LOTION TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part352 A-Cute Derm, Incorporated OCTINOXATE; OXYBENZONE; PADIMATE O 75; 20; 50 mg/g; mg/g; mg/g N 20181231 61619-868_232d4805-ccc8-3f6e-e054-00144ff88e88 61619-868 HUMAN OTC DRUG PRO-TECT EVERYDAY SUNSCREEN SPF 15 Octinoxate, Octisalate, Padimate O LOTION TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part352 A-Cute Derm, Incorporated OCTINOXATE; OXYBENZONE; PADIMATE O 75; 20; 50 mg/g; mg/g; mg/g N 20181231 61619-868_232d8697-08de-4336-e054-00144ff88e88 61619-868 HUMAN OTC DRUG PRO-TECT EVERYDAY SUNSCREEN SPF 15 Octinoxate, Octisalate, Padimate O LOTION TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part352 A-Cute Derm, Incorporated OCTINOXATE; OXYBENZONE; PADIMATE O 75; 20; 50 mg/g; mg/g; mg/g N 20181231 61619-868_3206b274-ed26-5672-e054-00144ff88e88 61619-868 HUMAN OTC DRUG PRO-TECT EVERYDAY SUNSCREEN SPF 15 Octinoxate, Octisalate, Padimate O LOTION TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part352 A-Cute Derm, Incorporated OCTINOXATE; OXYBENZONE; PADIMATE O 75; 20; 50 mg/g; mg/g; mg/g N 20181231 61625-682_d0ada552-23e6-40be-b70a-9732a5922103 61625-682 HUMAN OTC DRUG Piranha Brand Alcohol Free Foaming Instant Hand Sanitizer with Aloe and Vitamin E Foaming Instant Hand Sanitizer with Aloe and Vitamin E SOLUTION TOPICAL 20130517 OTC MONOGRAPH NOT FINAL part333A Bio Shine, Inc. BENZETHONIUM CHLORIDE 7.56 g/100mL E 20171231 61625-688_bb8f9d5a-e53f-40f4-baa3-d854bf6d0477 61625-688 HUMAN OTC DRUG Piranha Brand Foaming Alcohol Hand Sanitizer Foaming Hand Sanitizer SOLUTION TOPICAL 20130627 OTC MONOGRAPH NOT FINAL part333A Bio Shine, Inc. ALCOHOL 62 mL/100mL E 20171231 61625-689_b4658d6f-09ab-4b75-9bb3-df10391d940d 61625-689 HUMAN OTC DRUG Piranha Brand Foaming Antibacterial Hand Foaming Antibacterial Hand Soap with Aloe and Vitamin E SOLUTION TOPICAL 20130923 OTC MONOGRAPH NOT FINAL part333A Bio Shine, Inc. TRICLOSAN 18.9 g/100mL E 20171231 61649-001_bcc6497c-4f28-470e-b234-3fccf694f11e 61649-001 HUMAN OTC DRUG ATTITUDE Mineral sunscreen ZINC OXIDE CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bio Spectra ZINC OXIDE 20 g/100g N 20181231 61649-002_e5e1b8b2-0794-45dd-a173-401d9cff680c 61649-002 HUMAN OTC DRUG ATTITUDE Mineral sunscreen vanilla blossom ZINC OXIDE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 Bio Spectra ZINC OXIDE 20 g/100g N 20181231 61649-003_fcf54041-d912-4adb-8ec7-f4475956014b 61649-003 HUMAN OTC DRUG ATTITUDE Mineral sunscreen Sensitive Skin Care little ones ZINC OXIDE CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bio Spectra ZINC OXIDE 20 g/100g N 20181231 61649-004_f2b2625d-39e3-4920-aae7-56e3e4da255a 61649-004 HUMAN OTC DRUG ATTITUDE Mineral sunscreen Sensitive Skin Care family ZINC OXIDE CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bio Spectra ZINC OXIDE 20 g/100g N 20181231 61649-008_c0b431d7-a94e-4fb8-a1f4-fe9896937691 61649-008 HUMAN OTC DRUG ATTITUDE ZINC OXIDE STICK TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bio Spectra ZINC OXIDE 20 g/100g E 20171231 61657-0001_c5f1da5a-0181-4772-88b1-97b8b483f4c4 61657-0001 HUMAN OTC DRUG Addasect ARSENIC TRIOXIDE,RED CLOVER,PHYTOLACCA AMERICANA ROOT LIQUID ORAL 20111001 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro West ARSENIC TRIOXIDE; TRIFOLIUM PRATENSE FLOWER; PHYTOLACCA AMERICANA ROOT; CHELIDONIUM MAJUS; TARAXACUM PALUSTRE ROOT; PETROSELINUM CRISPUM; PEUMUS BOLDUS LEAF; NITRIC ACID; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; STRYCHNOS NUX-VOMICA SEED; MERCURIC CHLORIDE; LIQUID PETROLEUM; PHOSPHORUS 12; 3; 6; 13; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0003_bfeda335-706e-4f99-a0f5-46d93c6c9898 61657-0003 HUMAN OTC DRUG Allerhale ARS ALB, PHOS,NUX VOM, PULS, SULPH, EUP, SOL, ECHI, BAPT LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro West ARSENIC TRIOXIDE; PHOSPHORUS; STRYCHNOS NUX-VOMICA SEED; ONION; PULSATILLA VULGARIS; SULFUR; EUPHRASIA STRICTA; SOLIDAGO VIRGAUREA FLOWERING TOP; ECHINACEA, UNSPECIFIED; GARLIC; BAPTISIA TINCTORIA 12; 12; 12; 12; 12; 12; 12; 12; 3; 3; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0006_3f58b116-d262-46a9-a6d2-09422574fcc0 61657-0006 HUMAN OTC DRUG Anxiolix ARSENICUM ALBUM ,SCUTELLARIA LATERIFLORA,PHOSPHORUS,LACHESIS MUTUS,PULSATILLA,PASSIFLORA INCARNATA,ACONITE,VALERIANA OFFICINALIS,CALCAREA CARBONICA,IGNATIA AMARA LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro West ARSENIC TRIOXIDE; SCUTELLARIA LATERIFLORA; PHOSPHORUS; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; PASSIFLORA INCARNATA FLOWERING TOP; ACONITUM NAPELLUS; VALERIAN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED 12; 3; 12; 15; 12; 3; 12; 3; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0015_1f35f9e9-b22b-4975-bfa1-4b5e84e11557 61657-0015 HUMAN OTC DRUG A-D-D (Attention Span) A-D-D LIQUID ORAL 20110801 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated DBA Micro-West BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAF 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0052_89c1c4b5-7c64-400f-b291-a4ec93ecbab0 61657-0052 HUMAN OTC DRUG BACTOFLAM ECHINACEA,BAPTISIA,APIS MELLIFICA ,FERRUM PHOSPHORICUM , LIQUID ORAL 20110610 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; APIS MELLIFERA; FERRUM PHOSPHORICUM; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; ARSENIC TRIOXIDE 3; 3; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0101_ee5a7ba8-57ad-40ca-b840-463f00499232 61657-0101 HUMAN OTC DRUG CAND-EX LYCOPODIUM,NUX VOMICA,BORAX,ASAFOETIDA,NUX MOSCHATA,GENTIANA LUTEA,KREOSOTUM,CALCAREA CARBONICA,SEPIA,PHOSPHORIC ACID,ECHINACEA,PULSATILLA,BAPTISIA, LIQUID ORAL 19930801 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; PHOSPHORIC ACID; WOOD CREOSOTE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM BORATE; GENTIANA LUTEA ROOT; NUTMEG; ASAFETIDA 30; 12; 3; 3; 30; 30; 12; 12; 12; 12; 3; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0104_947eab07-c68f-477e-b4e0-d42eb2cdb72f 61657-0104 HUMAN OTC DRUG CHRON SINO ARSENICUM ALBUM,MAGNESIA PHOSPHORICA,PULSATILLA,RHUS TOXICODENDRON,BAPTISIA,PHYTOLACCA,HYDRASTIS,SEPIA,ECHINACEA,MERCURIUS SOLUBILIS,KALI BICHROMICUM, LIQUID ORAL 20040105 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST ARSENIC TRIOXIDE; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; ECHINACEA, UNSPECIFIED; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; BAPTISIA TINCTORIA; TOXICODENDRON PUBESCENS LEAF; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12; 12; 12; 12; 12; 3; 3; 3; 3; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0154_62532773-3e7d-4863-9b7c-0bfb7a2b8613 61657-0154 HUMAN OTC DRUG DPT TOX HYPERICUM,ECHINACEA,MEZEREUM,DROSERA,THUJA,KALI MURIATICUM,,SILICA, LIQUID ORAL 19940110 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST ST. JOHN'S WORT; ECHINACEA, UNSPECIFIED; DAPHNE MEZEREUM BARK; SILICON DIOXIDE; THUJA PLICATA LEAF; POTASSIUM CHLORIDE; DROSERA ROTUNDIFOLIA 12; 12; 30; 12; 30; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0157_c96a65bd-b459-4dd1-9127-0906e98107e8 61657-0157 HUMAN OTC DRUG Drainage D-Tox Lymph CALCAREA SCROPHULARIA NODOSA,SULPHUR IODATUM ,SOLIDAGO VIRGAUREA,PULSATILLA,RICINUS COMMUNIS,KALI MURIATICUM,PHYTOLACCA DECANDRA,MERCURIUS VIVUS,IODATA,KALI IODATUM,BELLADONNA,HEPAR SULPHURIS CALCAREUM,ECHINACEA PURPUREA, LIQUID ORAL 19971005 UNAPPROVED HOMEOPATHIC White Manufacturing DBA Micro-West ATROPA BELLADONNA; CALCIUM IODIDE; ECHINACEA PURPUREA; CALCIUM SULFIDE; POTASSIUM IODIDE; POTASSIUM CHLORIDE; MERCURY; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RICINUS COMMUNIS SEED; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR IODIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0208_02680564-d7d4-48c6-b49b-923c45438c0d 61657-0208 HUMAN OTC DRUG Whole System EEP MERCURIUS CORROSIVUS,NUX VOMICA,HYOSCYAMINUM,CARCINOSINUM,GRAPHITES,ZINCUM METALLICUM,LILIUM TIGRINUM,CINCHONA OFFICINALIS,CAUSTICUM,COFFEA CRUDA,BELLADONNA,IGNATIA AMARA,SCROPHULARIA NODOSA,SPONGIA TOSTA ,CEANOTHUS AMERICANUS,SENNA,HYDRASTIS CANADENSIS,CONDURANGO,CHELIDONIUM MAJUS,PITUITARY GLAND, BOS TAURUS,PANCREAS SUIS,LYCOPODIUM CLAVATUM,BERBERIS VULGARIS, LIQUID ORAL 20050521 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West MERCURIC CHLORIDE; BERBERIS VULGARIS ROOT BARK; LYCOPODIUM CLAVATUM SPORE; SUS SCROFA PANCREAS; BOS TAURUS PITUITARY GLAND; CHELIDONIUM MAJUS; MARSDENIA CONDURANGO BARK; GOLDENSEAL; SENNA LEAF; CEANOTHUS AMERICANUS LEAF; SPONGIA OFFICINALIS SKELETON, ROASTED; SCROPHULARIA NODOSA; STRYCHNOS IGNATII SEED; ATROPA BELLADONNA; ARABICA COFFEE BEAN; CAUSTICUM; CINCHONA OFFICINALIS BARK; LILIUM LANCIFOLIUM WHOLE FLOWERING; ZINC; GRAPHITE; HUMAN BREAST TUMOR CELL; HYOSCYAMINE; STRYCHNOS NUX-VOMICA SEED 12; 12; 12; 12; 12; 3; 3; 3; 3; 6; 6; 15; 200; 1; 1; 5; 5; 5; 3; 2; 10; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_M]/30mL; [hp_M]/30mL; [hp_M]/30mL; [hp_M]/30mL; [hp_M]/30mL; [hp_M]/30mL; [hp_M]/30mL; [hp_M]/30mL; [hp_M]/30mL; [hp_M]/30mL N 20181231 61657-0251_18368423-ed66-468e-a19c-c60e7cf22162 61657-0251 HUMAN OTC DRUG Flualgia GELSEMIUM,ECHINACEA,BAPTISIA PHYTOLACCA DECANDRA,TINCTORIA,ARSENICUM ALBUM,IRIDIUM,MERCURIUS CORROSIVUS,EUPATORIUM PERFOLIATUM,BRYONIA,FERRUM PHOSPHORICUM, LIQUID ORAL 19920831 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West GELSEMIUM SEMPERVIRENS ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; BRYONIA ALBA ROOT; MERCURIC CHLORIDE; ARSENIC TRIOXIDE; IRIDIUM; ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; PHYTOLACCA AMERICANA ROOT 12; 12; 12; 12; 12; 12; 12; 3; 3; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0327_45c426f8-e07a-4cb4-832a-656ad0d98c78 61657-0327 HUMAN OTC DRUG HPZ HYPERICUM,NAT MUR,RAN B,THUJA,NITRIC ACID,RHUS TOX,GELSENICUM,ECHINACEA,LYCOPODUM,HYDRASTIS LIQUID ORAL 20110830 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ST. JOHN'S WORT; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAF; NITRIC ACID; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF; ECHINACEA PURPUREA; GOLDENSEAL 3; 12; 12; 12; 12; 12; 12; 3; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0377_c2b575c2-8756-410f-9bba-9e346a21d673 61657-0377 HUMAN OTC DRUG Immuno Bac PHOSPHORUS,ARSENIC TRIOXIDE,LACHESIS MUTA VENOM,PHYTOLACCA AMERICANA ROOT,BAPTISIA TINCTORIA,ECHINACEA,, LIQUID ORAL 20110830 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West PHOSPHORUS; ARSENIC TRIOXIDE; ECHINACEA, UNSPECIFIED; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; BAPTISIA TINCTORIA; GOLDENSEAL; FERRIC PHOSPHATE; RANCID BEEF; ATROPA BELLADONNA 12; 12; 3; 15; 12; 3; 3; 12; 30; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0526_ad208744-0dc8-47b8-83a1-cdd6330bcea5 61657-0526 HUMAN OTC DRUG Met-Tox Arsenicum Album, Avena Sativa,Lycopodium Clavatum,Natrum Muriaticum,Nux Vomica,Phytolacca DecandraRhamnus Frangula,Solidago Virgaurea,Trifolium Pratense,Heavy Metal Nosodes LIQUID ORAL 20060124 UNAPPROVED HOMEOPATHIC wHITE mANUFACTURING INC DBA MICRO-WEST ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; FRANGULA ALNUS BARK; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIFOLIUM PRATENSE FLOWER; IRON; MAGNESIUM; SULFUR; CHROMIUM; ALUMINUM; CALCIUM; ACTIVATED CHARCOAL; SILICON; SELENIUM; ZINC; BORON; COBALT; BERYLLIUM; TIN; ANTIMONY; CERIUM; CESIUM; ARSENIC; ZIRCONIUM; STRONTIUM; NEODYMIUM; LEAD; CHLORIDE ION; LITHIUM; COPPER; BROMINE; SODIUM; YTTRIUM; IODINE; GADOLINIUM; FLUORIDE ION; SAMARIUM; CADMIUM; DYSPROSIUM; MERCURY; TITANIUM; POTASSIUM; RUBIDIUM; ERBIUM; VANADIUM; SCANDIUM; RUTHENIUM; LUTETIUM; HOLMIUM; PRASEODYMIUM; TERBIUM; BARIUM; TELLURIUM; NIOBIUM; PALLADIUM; HAFNIUM; TANTALUM; MOLYBDENUM; EUROPIUM; GALLIUM; GOLD; OSMIUM; PLATINUM; RHODIUM; INDIUM; SILVER; THORIUM; IRIDIUM; HYDROGEN; NITROGEN; YTTERBIUM 12; 3; 3; 12; 12; 12; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0527_a74de49f-2bc6-40df-9904-7b9dad9b8820 61657-0527 HUMAN OTC DRUG MENOPAUSE CIMICIFUGA RACEMOSASANGUINARIA,SEPIA,BELLADONNA,LACHESIS MUTUS,SULFUR,USTILAGO MAIDIS,PULSATILLA , LIQUID ORAL 19931201 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West BLACK COHOSH; SEPIA OFFICINALIS JUICE; PULSATILLA VULGARIS; USTILAGO MAYDIS; SULFUR; LACHESIS MUTA VENOM; ATROPA BELLADONNA; SANGUINARIA CANADENSIS ROOT 3; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; mL/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 61657-0904_6c0b0a09-0e80-4728-b974-6d0202844865 61657-0904 HUMAN OTC DRUG Surgery/Trauma HYPERICUM,ARNICA,SYMPHYTUM OFFICINALE, BELLIS PERENNIS, STAPHYSAGRIA LIQUID ORAL 20110701 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ST. JOHN'S WORT; ARNICA MONTANA FLOWER; COMFREY ROOT; BELLIS PERENNIS; DELPHINIUM STAPHISAGRIA SEED 30; 200; 6; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0915_6a2bb31c-4326-4bbf-85f3-932a0af4dd28 61657-0915 HUMAN OTC DRUG SMOKE-X ARSENICUM ALBUM,PLANTAGO MAJOR,THUJA OCCIDENTALIS,TABACUM,STAPHYSAGRIA,SACCHARUM OFFICINALE,DAPHNE INDICA,NUX VOMICA,NICOTINUM,LOBELIA INFLATA,KALI PHOSPHORICUM,EUGENIA JAMBOSA,CARBOLICUM ACIDUM,CALADIUM SEGUINUM, LIQUID ORAL 20060720 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ARSENIC TRIOXIDE; DIEFFENBACHIA SEGUINE; PHENOL; DAPHNE ODORA BARK; SYZYGIUM JAMBOS SEED; POTASSIUM PHOSPHATE, DIBASIC; LOBELIA INFLATA; NICOTINE; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; SUCROSE; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF; THUJA OCCIDENTALIS LEAF 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0952_a84dd078-1a30-422d-9688-e5e90d498912 61657-0952 HUMAN OTC DRUG Thyroid IODIUM,BADIAGA,FUCUS VESICULOSUS,CALCAREAARSENICUM IODATUM, THYROIDINUM,CARBONICA,PULSATILLA,BARYTA CARBONICA, LIQUID ORAL 19960826 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West IODINE; PULSATILLA VULGARIS; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; THYROID, UNSPECIFIED; ARSENIC TRIIODIDE; FUCUS VESICULOSUS; SPONGILLA LACUSTRIS 12; 12; 12; 12; 12; 12; 3; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0955_fed37642-1e40-4052-adef-dc01942519ad 61657-0955 HUMAN OTC DRUG Total Aluminum Aluminum Metal LIQUID ORAL 20110930 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ALUMINUM 12 [hp_X]/30mL N 20181231 61657-0956_3da891a6-a974-4ca6-bcf1-d7e7dbd97b16 61657-0956 HUMAN OTC DRUG Total Arsenicum Arsenicum Album LIQUID ORAL 20151001 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated DBA Micro-West ARSENIC TRIOXIDE 12 [hp_X]/30mL N 20181231 61657-0957_0c6baa25-1198-42b7-b442-3de86168c8ef 61657-0957 HUMAN OTC DRUG Total Barium Barium LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated DBA Micro-West BARIUM CARBONATE 12 [hp_X]/30mL N 20181231 61657-0958_900d5f4d-3542-4ad5-a5db-84c1b1c3445e 61657-0958 HUMAN OTC DRUG Total Cadmium CADMIUM SULPHURATUM LIQUID ORAL 20110901 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro West CADMIUM SULFIDE 12 [hp_X]/30mL N 20181231 61657-0959_042da72a-8b2e-4fd6-8632-4563199f37c5 61657-0959 HUMAN OTC DRUG Total Copper CUPRUM METALLICUM LIQUID ORAL 20110630 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West COPPER 12 [hp_X]/30mL N 20181231 61657-0960_e8a24f55-08bb-474b-af09-10020627a035 61657-0960 HUMAN OTC DRUG Total Lead PLUMBUM METALLICUM LIQUID ORAL 20110630 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West LEAD 12 [hp_X]/30mL N 20181231 61657-0961_16a16ae2-1371-4b8d-b9ce-94e87defe16e 61657-0961 HUMAN OTC DRUG TOTAL MERCURY MERCURIUS VIVUS LIQUID ORAL 20110101 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West MERCURY 12 [hp_X]/30mL N 20181231 61657-0962_40a1661d-6506-49af-86ee-b24c75078411 61657-0962 HUMAN OTC DRUG Total Niccolum Niccolum Metallicum LIQUID ORAL 20110830 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West NICKEL 10 [hp_C]/30mL N 20181231 61657-0963_07822be6-4551-4b2e-b131-dfea493579a0 61657-0963 HUMAN OTC DRUG Total Radium Radium Bromide LIQUID ORAL 20110830 UNAPPROVED HOMEOPATHIC White Manufacturing Inc DBA Micro West RADIUM BROMIDE 10 [hp_C]/30mL N 20181231 61657-0964_c295ca6e-274a-4658-ae88-a94794e5e2b8 61657-0964 HUMAN OTC DRUG Total Thallium thallium LIQUID ORAL 20110601 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West THALLIUM 12 [hp_X]/30mL E 20171231 61657-0965_68782815-b42e-4a4e-aa0a-4755c9471aec 61657-0965 HUMAN OTC DRUG Total Uranium Uranium Nitricum LIQUID ORAL 20110801 UNAPPROVED HOMEOPATHIC White Manufacturing Inc, DBA Micro-West URANYL NITRATE HEXAHYDRATE 15 [hp_X]/30mL N 20181231 61657-0966_bf290ab8-bc14-4c07-9415-8a703fccc3be 61657-0966 HUMAN OTC DRUG Total Antimony antimonium tartaricum LIQUID ORAL 20110713 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro -West ANTIMONY POTASSIUM TARTRATE 12 [hp_X]/30mL N 20181231 61657-0967_2a24aa66-7c87-4f81-a4d3-2f0b450ef6f6 61657-0967 HUMAN OTC DRUG TOTAL TIN STANNUM METALLICUM LIQUID ORAL 20110615 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST TIN 12 [hp_X]/30mL E 20171231 61657-0968_ed7f4671-62cf-4f14-891d-71e6bab5eee8 61657-0968 HUMAN OTC DRUG Total FLU-CLD 1 ARSENICUM ALBUM,SULPHUR,ANAS BARBARIAE,WYETHIA HELENIOIDES,SARCOLACTICUM ACIDUM,RHUS TOXICODENDRON,PHYTOLACCA DECANDRA,LACHESIS MUTUS,GELSEMIUM SEMPERVIRENS,EUCALYPTUS GLOBULUS,ECHINACEA PURPUREA,EUPATORIUM PERFOLIATUM,DULCAMARA,,CINCHONA OFFICINALIS,BRYONIA ALBA,CAUSTICUM,BAPTISIA TINCTORIA, LIQUID NASAL 20070319 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CAUSTICUM; CINCHONA OFFICINALIS BARK; SOLANUM DULCAMARA FLOWER; EUPATORIUM PERFOLIATUM FLOWERING TOP; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; WYETHIA HELENIOIDES ROOT; INFLUENZA A VIRUS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 35 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL N 20181231 61657-0969_bcb06e82-7dcf-4b0b-9cc0-e4d2985d2653 61657-0969 HUMAN OTC DRUG Total Tri-Estro Adrenalinum,Cimicfuga Racemosa,Ignatia Amara,Nicotinamide,Sepia,Estradiol,Oophorinum,Estriol,Estrone LIQUID ORAL 20070401 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West EPINEPHRINE; BLACK COHOSH; STRYCHNOS IGNATII SEED; EGG PHOSPHOLIPIDS; NIACINAMIDE; SEPIA OFFICINALIS JUICE; ESTRADIOL; SUS SCROFA OVARY; ESTRIOL; ESTRONE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0970_aa6655d5-6e99-4f6b-b317-1bcb158d02b3 61657-0970 HUMAN OTC DRUG TOTAL ANDRO-BAL DAMIANA, LECITHINUM,PHOSPHORICUM ACIDUM,SABAL SERRATA, CHOSESTERINUM,DNA,HYPOTHALAMUS,ADRENAL CORTEX, DHEA,PREGNENOLONE,PROGESTERONE,TESTOSTERONE LIQUID ORAL 20070401 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST TURNERA DIFFUSA LEAFY TWIG; EGG PHOSPHOLIPIDS; PHOSPHORIC ACID; SAW PALMETTO; CHOLESTEROL; HERRING SPERM DNA; BOS TAURUS HYPOTHALAMUS; SUS SCROFA ADRENAL GLAND; PRASTERONE; PREGNENOLONE; PROGESTERONE; TESTOSTERONE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0971_41aa131b-f353-4a65-9b7e-451e7beafc9b 61657-0971 HUMAN OTC DRUG TOTAL FEM-BAL ADRENALINUM,PULSATILLA,CHOLESTERINUM,FOLLICULINUM,HYPOTHALAMUS,OOPHORINUM,ADRENAL CORTEX, ANDROSTENEDIONE,DHEA,PREGNANOLONE,PROGESTERONE,TESTERONE LIQUID ORAL 20070402 UNAPPROVED HOMEOPATHIC WHITE MANUFACTURING INC. DBA MICRO WEST EPINEPHRINE; PULSATILLA VULGARIS; CHOLESTEROL; ESTRONE; BOS TAURUS HYPOTHALAMUS; SUS SCROFA OVARY; ANDROSTENEDIONE; PRASTERONE; PREGNENOLONE; PROGESTERONE; TESTOSTERONE; SUS SCROFA ADRENAL GLAND 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-0972_ccfcc191-316f-4502-be6b-736e9a852257 61657-0972 HUMAN OTC DRUG Total Bromine Bromine LIQUID ORAL 20110729 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated DBA Micro-West BROMINE 15 [hp_X]/30mL N 20181231 61657-0973_8247cc17-dc8d-449b-b530-90f44e81f71b 61657-0973 HUMAN OTC DRUG Total Chlorine Chlorinum LIQUID ORAL 20110815 UNAPPROVED HOMEOPATHIC White Manufacturing Incorporated DBA Micro-West CHLORINE 15 [hp_X]/30mL N 20181231 61657-0974_bb9c54c5-715f-4055-90bd-b7866b8fd9f6 61657-0974 HUMAN OTC DRUG TOTAL PRO-JES ADRENAL,BELLADONNA,CHELIDONIUM,DIOSCOREAVILLOSA,FOLLICULINUM,HYPOTHALAMUS,ARGININE,LILIumTIGRINIUM,LIVER,OOPHORINUM,PINEAL,PITUITARINUM,PLACENTANIUM,PROGESTERONE LIQUID ORAL 20110915 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. BDA Micro-West PROGESTERONE; EPINEPHRINE; ATROPA BELLADONNA; CHELIDONIUM MAJUS; DIOSCOREA VILLOSA ROOT; ESTRONE; BOS TAURUS HYPOTHALAMUS; ARGININE; LILIUM LANCIFOLIUM FLOWERING TOP; MAMMAL LIVER; SUS SCROFA OVARY; BOS TAURUS PINEAL GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PLACENTA; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SULFUR 6; 6; 6; 6; 6; 6; 6; 6; 12; 6; 6; 6; 6; 6; 12; 12; 12 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL N 20181231 61657-1026_99aedc91-5acf-4f8a-8e40-ef8d0aa3fed1 61657-1026 HUMAN OTC DRUG Vermafuge -AG Lycopodium NUX VOMICA,ARSENICUM ALBUM,CINCHONA OFFICINALIS,CAPSICUM ANNUUM,NITRIC ACID,MERCURIUSCORROSIVUS,BELLADONNA,CAJUPUTUM,LYCOPODIUM CLAVATUM,PHOSPHORUS,PHYTOLACCA DECANDRA,RHAMNUS PURSHIANA,FRAGARIA VESCA LIQUID ORAL 19930803 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro-West STRYCHNOS NUX-VOMICA SEED; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; CAPSICUM; NITRIC ACID; MERCURIC CHLORIDE; ATROPA BELLADONNA; CAJUPUT OIL; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; FRANGULA PURSHIANA BARK; ALPINE STRAWBERRY 12; 12; 12; 3; 12; 12; 12; 4; 12; 12; 6; 3; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61657-1027_1346f883-a93e-4798-8b79-5fc008e341c8 61657-1027 HUMAN OTC DRUG VIREX ARSENIC TRIOXIDE,ECHINACEA,ATROPA BELLADONNA,TOXICODENDRON PUBESCENS LEAF,LYCOPODIUM CLAVATUM SPORE,STRYCHNOS NUX-VOMICA SEED,GELSEMIUM SEMPERVIRENS ROOT, LIQUID ORAL 20110729 UNAPPROVED HOMEOPATHIC White Manufacturing Inc. DBA Micro West ARSENIC TRIOXIDE; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; LYCOPODIUM CLAVATUM SPORE; ATROPA BELLADONNA; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; EUPATORIUM PERFOLIATUM FLOWERING TOP; BAPTISIA TINCTORIA; PHOSPHORUS; FOSCOLIC ACID 12; 3; 12; 12; 12; 12; 30; 30; 12; 3; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 61658-001_e4112ae6-92eb-4626-b220-6aea21a811ca 61658-001 HUMAN OTC DRUG YUNNAN BAIYAO ARTHRITIS PAIN RELIEF Camphor, Capsaicin, Methyl Salicylate PLASTER TOPICAL 20150618 OTC MONOGRAPH NOT FINAL part348 YUNNAN BAIYAO GROUP CO., LTD. CAMPHOR (SYNTHETIC); CAPSAICIN; METHYL SALICYLATE 128.04; 2.88; 168.03 mg/1; mg/1; mg/1 E 20171231 61660-500_92ca80d4-7084-4834-9447-a9750555cdb0 61660-500 HUMAN OTC DRUG IC Clear LUBRICANT EYE DROPS Glycerin SOLUTION/ DROPS OPHTHALMIC 20170801 OTC MONOGRAPH FINAL part349 Oboi Laboratories Pvt Ltd GLYCERIN 1 g/100mL N 20181231 61666-000_c7dcb44b-de90-46ed-a62d-bf755050db31 61666-000 HUMAN OTC DRUG Clear-Tone Antibacterial Hand CHLOROXYLENOL SOAP TOPICAL 20140107 OTC MONOGRAPH NOT FINAL part333A Waxie Sanitary Supply CHLOROXYLENOL 2.5 mg/mL N 20181231 61666-001_e7839bb0-9e91-4807-9838-40e351c61b3e 61666-001 HUMAN OTC DRUG ANTIBACTERIAL HAND CHLOROXYLENOL SOAP TOPICAL 20140107 OTC MONOGRAPH NOT FINAL part333A Waxie Sanitary Supply CHLOROXYLENOL 2.5 mg/mL N 20181231 61666-002_cd9a8afa-5e2f-44a2-b23f-5672d76a195d 61666-002 HUMAN OTC DRUG ANTIBACTERIAL HAND CHLOROXYLENOL SOAP TOPICAL 20140107 OTC MONOGRAPH NOT FINAL part333A Waxie Sanitary Supply CHLOROXYLENOL 2.5 mg/mL N 20181231 61666-003_6cc277de-6e57-44fe-8d38-1c96642e746b 61666-003 HUMAN OTC DRUG Antimicrobial Hand So ap Chloroxylenol LIQUID TOPICAL 20030101 OTC MONOGRAPH NOT FINAL part333E Waxie Sanitary Supply CHLOROXYLENOL .003 mg/mL N 20181231 61666-004_c951badf-ff88-4b91-bfac-af20cc70572f 61666-004 HUMAN OTC DRUG WAXIECARE Pink Antibacterial Ltion So ap CHLOROXYLENOL LIQUID TOPICAL 20020815 OTC MONOGRAPH NOT FINAL part333E Waxie Sanitary Supply CHLOROXYLENOL .003 mg/mL N 20181231 61666-005_2803dc26-5760-4061-b3a2-5c916e1ce133 61666-005 HUMAN OTC DRUG Antimicrobial Foam So ap with PCMX Chloroxylenol LIQUID TOPICAL 20060615 OTC MONOGRAPH NOT FINAL part333E Waxie Sanitary Supply CHLOROXYLENOL .003 mg/mL N 20181231 61666-006_98a29842-cf83-469d-9f6b-cf9b195fa7d2 61666-006 HUMAN OTC DRUG Antimicrobial Foam So ap Chloroxylenol LIQUID TOPICAL 20060830 OTC MONOGRAPH NOT FINAL part333E Waxie Sanitary Supply CHLOROXYLENOL .003 mg/mL N 20181231 61666-007_310a6447-8547-40b9-8ace-54d3d7bf22dc 61666-007 HUMAN OTC DRUG GRAND TOUCH Antimicrobial Ltion So ap Chloroxylenol LIQUID TOPICAL 20100330 OTC MONOGRAPH NOT FINAL part333E Waxie Sanitary Supply CHLOROXYLENOL .003 mg/mL N 20181231 61666-008_476f63f1-a234-49ce-9be9-3fbba00b53ee 61666-008 HUMAN OTC DRUG Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170415 OTC MONOGRAPH NOT FINAL part333E Waxie Sanitary Supply BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 61667-001_d3078cbf-16a0-469b-99a0-b20d6b4ab5a4 61667-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19830101 NDA NDA205840 Baystate Home Infusion & Respiratory Services OXYGEN 99 L/100L N 20181231 61671-003_de7705b6-2bbd-430f-85f1-b82ac4d319dd 61671-003 HUMAN OTC DRUG Body Scrub Glycerin and Kaolin GEL TOPICAL 20140108 OTC MONOGRAPH FINAL part347 Milk & Co Pty Ltd GLYCERIN; KAOLIN 7.5; 6 g/375g; g/375g E 20171231 61671-004_e4206daf-0b70-4e4c-adf1-40ffb9c8ded9 61671-004 HUMAN OTC DRUG Face Moisturiser Avobenzone and Octinoxate LOTION TOPICAL 20140108 OTC MONOGRAPH NOT FINAL part352 Milk & Co Pty Ltd AVOBENZONE; OCTINOXATE 3; 7 g/150g; g/150g E 20171231 61680-0622_5d7ffd74-1b8e-432c-9ac9-071c0d729c04 61680-0622 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19950622 UNAPPROVED MEDICAL GAS South East Alaska Medical Suppliers Inc. OXYGEN 99 L/100L E 20171231 61699-0047_0215200c-b492-43b5-a62d-248b0df55cf4 61699-0047 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140718 NDA NDA011856 US MedSource, LLC METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61699-0201_8c77a533-c7d7-43d2-802e-09a333d82a56 61699-0201 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20140702 ANDA ANDA080404 US MedSource, LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 61699-1966_8e4ff226-d15f-49d5-a09d-47e6b3c1471d 61699-1966 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAVENOUS 20140725 NDA NDA018800 US MedSource, LLC SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 61699-3178_18c4753b-0899-4d27-beff-65b5e4aaff02 61699-3178 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20140612 ANDA ANDA089644 US MedSource, LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE 10; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 61699-3182_8307126e-bba5-4993-a315-d9a51fa15315 61699-3182 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine LIDOCAINE HYDROCHLORIDE ANHYDROUS and EPINEPHRINE INJECTION, SOLUTION INFILTRATION 20140614 ANDA ANDA089646 US MedSource, LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE 20; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 61699-3977_6e65e7f5-4fc6-4e62-ba43-0848fb4a8cb7 61699-3977 HUMAN PRESCRIPTION DRUG Bacteriostatic Water WATER INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140707 NDA NDA018802 US MedSource, LLC WATER 1 mL/mL E 20171231 61699-4276_65cfa1eb-a6ee-4309-a609-6cf23063e505 61699-4276 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20140529 ANDA ANDA088299 US MedSource, LLC LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 61699-4277_8d7badf9-a36c-40c0-a205-5dce6cdc2994 61699-4277 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20140612 ANDA ANDA088327 US MedSource, LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 61699-4888_94b8a474-b1c7-4dc3-a915-c6c1ed2baf51 61699-4888 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140619 NDA NDA018803 US MedSource, LLC SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 61699-6625_4465436b-27a9-4380-810e-f9009ac75a0b 61699-6625 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate SODIUM BICARBONATE INJECTION, SOLUTION INTRAVENOUS 20140703 UNAPPROVED DRUG OTHER US MedSource, LLC SODIUM BICARBONATE 84 mg/mL E 20171231 61703-303_64b57008-64bc-47db-ac35-94b193b41665 61703-303 HUMAN PRESCRIPTION DRUG CYTARABINE CYTARABINE INJECTION, SOLUTION INTRAVENOUS 19900831 ANDA ANDA072168 Hospira, Inc. CYTARABINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 61703-304_80330301-0aed-4556-9a60-fa231d92b74c 61703-304 HUMAN PRESCRIPTION DRUG Cytarabine CYTARABINE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 19940228 ANDA ANDA072945 Hospira, Inc. CYTARABINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 61703-305_4ee12e37-76a7-446a-bcbd-d7dda34b1526 61703-305 HUMAN PRESCRIPTION DRUG Cytarabine CYTARABINE INJECTION, SOLUTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 19900604 ANDA ANDA071868 Hospira Worldwide, Inc. CYTARABINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 61703-309_2b65d778-b293-496b-808e-717e5d97305d 61703-309 HUMAN PRESCRIPTION DRUG VinCRIStine Sulfate VINCRISTINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20131127 ANDA ANDA071484 Hospira, Inc. VINCRISTINE SULFATE 1 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] N 20181231 61703-309_8529b131-9844-4dd9-849e-4f182fb8bae0 61703-309 HUMAN PRESCRIPTION DRUG VinCRIStine Sulfate VINCRISTINE SULFATE INJECTION, SOLUTION INTRAVENOUS 19880419 ANDA ANDA071484 Hospira, Inc. VINCRISTINE SULFATE 1 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] N 20181231 61703-319_7dd99a7b-b8ac-4267-a795-5f1b0ce513eb 61703-319 HUMAN PRESCRIPTION DRUG Cytarabine CYTARABINE INJECTION, SOLUTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 19991122 ANDA ANDA075383 Hospira, Inc. CYTARABINE 100 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 61703-323_f7e4a09f-d094-45e3-8daa-e4675c35294f 61703-323 HUMAN PRESCRIPTION DRUG Bleomycin BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20000410 ANDA ANDA065031 Hospira, Inc. BLEOMYCIN SULFATE 30 [USP'U]/1 Cytoprotective Agent [EPC] N 20181231 61703-324_828e5050-57f4-40c5-844f-d690cb8ebeda 61703-324 HUMAN PRESCRIPTION DRUG Pamidronate Disodium PAMIDRONATE DISODIUM INJECTION, SOLUTION INTRAVENOUS 20051001 ANDA ANDA075841 Hospira, Inc. PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 61703-325_828e5050-57f4-40c5-844f-d690cb8ebeda 61703-325 HUMAN PRESCRIPTION DRUG Pamidronate Disodium PAMIDRONATE DISODIUM INJECTION, SOLUTION INTRAVENOUS 20030728 ANDA ANDA075841 Hospira, Inc. PAMIDRONATE DISODIUM 6 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 61703-326_828e5050-57f4-40c5-844f-d690cb8ebeda 61703-326 HUMAN PRESCRIPTION DRUG Pamidronate Disodium PAMIDRONATE DISODIUM INJECTION, SOLUTION INTRAVENOUS 20051001 ANDA ANDA075841 Hospira, Inc. PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 61703-327_58c388d8-1938-4fb1-a54b-fda12b9ff160 61703-327 HUMAN PRESCRIPTION DRUG Dacarbazine DACARBAZINE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20030701 ANDA ANDA075940 Hospira Worldwide, Inc. DACARBAZINE 10 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 61703-332_f7e4a09f-d094-45e3-8daa-e4675c35294f 61703-332 HUMAN PRESCRIPTION DRUG Bleomycin BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20000411 ANDA ANDA065031 Hospira, Inc. BLEOMYCIN SULFATE 15 [USP'U]/1 Cytoprotective Agent [EPC] N 20181231 61703-339_ed06a815-8048-4801-ab50-3f229788989f 61703-339 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20041014 ANDA ANDA076517 Hospira, Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 61703-341_c69e797e-1698-478d-84bc-02e5c6ab9949 61703-341 HUMAN PRESCRIPTION DRUG VINORELBINE vinorelbine INJECTION, SOLUTION INTRAVENOUS 20070402 ANDA ANDA076827 Hospira, Inc. VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] N 20181231 61703-342_db9a00d9-2ddb-47cc-8528-a180f3f2c75d 61703-342 HUMAN PRESCRIPTION DRUG Paclitaxel PACLITAXEL INJECTION, SOLUTION INTRAVENOUS 20040301 ANDA ANDA076131 Hospira, Inc. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 61703-343_2a4e82a5-e240-45d9-8285-292ad234bfb1 61703-343 HUMAN PRESCRIPTION DRUG Mitoxantrone Mitoxantrone INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20060411 ANDA ANDA076871 Hospira, Inc. MITOXANTRONE HYDROCHLORIDE 2 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 61703-344_5696ab73-377f-4315-9aff-952ed5edc054 61703-344 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080925 ANDA ANDA077790 Hospira, Inc. FLUDARABINE PHOSPHATE 50 mg/2mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 61703-349_a1c6da3c-0480-430b-a810-e740cd0dff29 61703-349 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20080227 ANDA ANDA077915 Hospira, Inc. IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 61703-350_35ae2eea-99f0-4f2b-99bc-8c563cb373e7 61703-350 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRAVENOUS 19590810 NDA NDA011719 Hospira Worldwide, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 61703-350_cc893814-21f6-4682-83d8-8e7a2af13e85 61703-350 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRAVENOUS 20140925 NDA NDA011719 Hospira Worldwide, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 61703-363_50461166-07d2-4acd-8e8a-10db62cb7f61 61703-363 HUMAN PRESCRIPTION DRUG Oxaliplatin OXALIPLATIN INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20090810 ANDA ANDA078813 Hospira, Inc. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 61703-408_205b661d-499d-479f-af0c-1b081d224dd2 61703-408 HUMAN PRESCRIPTION DRUG Methotrexate METHOTREXATE INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 19590810 NDA NDA011719 Hospira Worldwide, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 61703-408_3b774024-f8cb-4d66-8aef-8f4d6fa8ea00 61703-408 HUMAN PRESCRIPTION DRUG Methotrexate METHOTREXATE INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20131111 20180331 NDA NDA011719 Hospira, Inc. METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 61703-418_92183c60-df3d-431c-8a1b-81e3be048923 61703-418 HUMAN PRESCRIPTION DRUG AQUASOL A VITAMIN A PALMITATE INJECTION, SOLUTION INTRAMUSCULAR 19490518 NDA NDA006823 Hospira Worldwide, Inc. VITAMIN A PALMITATE 15 mg/mL N 20181231 61703-421_1dc806ec-d48b-4b0a-84be-0b649bd89d97 61703-421 HUMAN PRESCRIPTION DRUG M.V.I. Pediatric ascorbic acid, retinol, ergocalciferol, thiamine hydrochloride, riboflavin 5-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, .alpha.-tocopherol acetate, dl-, biotin, folic acid, cyanocobalamin, and phytonadione INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060701 NDA NDA018920 Hospira, Inc. ASCORBIC ACID; RETINOL; ERGOCALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; NIACINAMIDE; DEXPANTHENOL; .ALPHA.-TOCOPHEROL ACETATE, DL-; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; PHYTONADIONE 80; .7; 10; 1.2; 1.4; 1; 17; 5; 7; 20; 140; 1; 200 mg/5mL; mg/5mL; ug/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; ug/5mL; ug/5mL; ug/5mL; ug/5mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 61703-422_0bb23e3f-484a-40c4-b725-f1a9a8e87214 61703-422 HUMAN PRESCRIPTION DRUG M.V.I. Adult retinol, ergocalciferol, .alpha.-tocopherol acetate, dl-, phytonadione, ascorbic acid, niacinamide, riboflavin 5-phosphate sodium, thiamine hydrochloride, pyridoxine hydrochloride, dexpanthenol, biotin, folic acid, and cyanocobalamin KIT 20040715 20180501 NDA NDA021625 Hospira, Inc. N 20181231 61703-422_44da4a20-9547-498d-9a23-40aa1b562bfd 61703-422 HUMAN PRESCRIPTION DRUG M.V.I. Adult retinol, ergocalciferol, .alpha.-tocopherol acetate, dl-, phytonadione, ascorbic acid, niacinamide, riboflavin 5-phosphate sodium, thiamine hydrochloride, pyridoxine hydrochloride, dexpanthenol, biotin, folic acid, and cyanocobalamin KIT 20150127 NDA NDA021643 Hospira, Inc. N 20181231 61703-434_44da4a20-9547-498d-9a23-40aa1b562bfd 61703-434 HUMAN PRESCRIPTION DRUG M.V.I. Adult retinol, ergocalciferol, .alpha.-tocopherol acetate, dl-, phytonadione, ascorbic acid, niacinamide, riboflavin 5-phosphate sodium, thiamine hydrochloride, pyridoxine hydrochloride, dexpanthenol, biotin, folic acid, and cyanocobalamin KIT 20170428 NDA NDA021625 Hospira, Inc. N 20181231 61715-010_fe8a218f-94dd-485d-b42c-dbfbf7e5b3a5 61715-010 HUMAN OTC DRUG Stay Awake CAFFEINE TABLET ORAL 20130509 OTC MONOGRAPH FINAL part340 Kinray Inc. CAFFEINE 200 mg/1 N 20181231 61715-011_25a01ed7-1704-4cfb-8ff0-69d390019f61 61715-011 HUMAN OTC DRUG Sinus Congestion and Pain Severe ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130509 OTC MONOGRAPH FINAL part341 Kinray Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 61715-012_c7ceb971-4f74-43c2-96af-1ae13fc9a98c 61715-012 HUMAN OTC DRUG Preferred Plus Chest Congestion Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Kinray GUAIFENESIN 400 mg/1 N 20181231 61715-013_d5676d5d-9361-4fbc-8608-092f14d70ce1 61715-013 HUMAN OTC DRUG Preferred Plus Chest Congestion Relief DMTDM TDM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Kinray DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 61715-014_db128f5a-6a92-45d3-ba1a-61d9c601a4f4 61715-014 HUMAN OTC DRUG Preferred Plus Chest Congestion Relief PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Kinray GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 61715-015_1fad27f7-d39a-479a-84b2-1dd4d3cb1cf3 61715-015 HUMAN OTC DRUG Preferred Plus Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20100104 UNAPPROVED DRUG OTHER Kinray PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 61715-016_9edc1bd1-94f1-46a1-87bc-7f2781e4757b 61715-016 HUMAN OTC DRUG Loratadine and Pseudoephedrine Loratadine and Pseudoephedrine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Kinray LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 61715-017_de98b206-8dbe-42f1-82ac-8c1f92a9e1af 61715-017 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Kinray LORATADINE 10 mg/1 N 20181231 61715-018_202ac623-305a-4005-bf14-ee5c4f276d0f 61715-018 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20111122 ANDA ANDA091355 Kinray IBUPROFEN 200 mg/1 N 20181231 61715-019_cf166ebb-d7d8-4a5e-921b-514d8576ca07 61715-019 HUMAN OTC DRUG Senna-S Sennosides and Docusate Sodium TABLET, FILM COATED ORAL 20110510 OTC MONOGRAPH NOT FINAL part334 Kinray Inc. SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 61715-020_eeccc94f-173f-464a-848b-473ac2d480ce 61715-020 HUMAN OTC DRUG Pain Relief BalmPreferred Plus Ph Preferred Plus Pharmacy Menthol GEL TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Kinray Inc. MENTHOL; METHYL SALICYLATE .076; .29 g/100g; g/100g N 20181231 61715-021_a5923fe0-836d-47a7-ace1-1dcbf94f318b 61715-021 HUMAN OTC DRUG Therapeutic Relief Preferred Plus Pharmacy Menthol GEL TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part348 Kinray Inc. MENTHOL 2 g/100g N 20181231 61715-022_4556921a-0003-445b-99d5-189b53abf778 61715-022 HUMAN OTC DRUG Burn ReliefPreferred Plus Ph Preferred Plus Pharmacy Lidocaine HCl GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part348 Kinray Inc. LIDOCAINE HYDROCHLORIDE .5 g/100mL N 20181231 61715-023_e0b2e235-9b25-462f-8b3d-6d668db6b053 61715-023 HUMAN OTC DRUG Broad Spectrum SPF 15 Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61715-024_1d9c7ffe-89e9-4493-8ad2-ae956dfb0b37 61715-024 HUMAN OTC DRUG Broad Spectrum SPF 30 Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 4; 5 g/100mL; g/100mL; g/100mL; g/100mL; 1/100mL N 20181231 61715-025_27dc87f1-9753-4838-b0f6-ea7fa7742181 61715-025 HUMAN OTC DRUG Broad Spectrum SPF 30 Sunscreen Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61715-026_b57772cf-ef47-422b-beb9-f83c452b7be2 61715-026 HUMAN OTC DRUG Broad Spectrum SPF 30 Sunscreen Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61715-027_2d039560-eeec-4c76-a40d-34f0bfa6a5c9 61715-027 HUMAN OTC DRUG Broad Spectrum SPF 50 Baby Sunscreen Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61715-028_8ef7c868-97a7-449f-89ee-d737a92f85c0 61715-028 HUMAN OTC DRUG Broad Spectrum SPF 50 Kids Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61715-029_22dc6a8c-3ab6-44bf-bb40-9e04074e1b90 61715-029 HUMAN OTC DRUG Broad Spectrum SPF 50 Sunscreen Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61715-030_196452d5-81ce-4cd8-9853-f5ae585c59cb 61715-030 HUMAN OTC DRUG Broad Spectrum SPF 70 Sunscreen Preferred Plus Pharmacy Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 Kinray Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 61715-031_9f1b1f17-5aaf-4533-b0f5-84a848a1895a 61715-031 HUMAN OTC DRUG Ear Wax Removing Drops Carbamide Peroxide Preferred Plus LIQUID AURICULAR (OTIC) 20130315 OTC MONOGRAPH FINAL part344 Kinray Inc CARBAMIDE PEROXIDE 6.5 g/100mL N 20181231 61715-032_1d4c86d3-c2ba-4cd6-8f3d-e1600ba9f75e 61715-032 HUMAN OTC DRUG Preferred Plus Arthritis Cream menthol topical analgesic CREAM TOPICAL 20010423 UNAPPROVED DRUG OTHER Kinray METHYL SALICYLATE; MENTHOL; CAPSAICIN 15; 10; .025 g/100g; g/100g; g/100g N 20181231 61715-033_deeb277e-284b-4f9b-80cd-c75c87c55d2e 61715-033 HUMAN OTC DRUG Preferred Plus Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20010423 UNAPPROVED DRUG OTHER Kinray PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 61715-035_affafdff-4b91-4ab1-bb85-d3b6983f443e 61715-035 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE ORAL 20100713 OTC MONOGRAPH NOT FINAL part334 Preferred Plus (Kinray) DOCUSATE SODIUM 100 mg/1 N 20181231 61715-037_70f36a17-a264-48a7-a4b3-e5f0df61ce38 61715-037 HUMAN OTC DRUG stool softener plus stimulant laxative docusate sodium and sennosides TABLET ORAL 20100715 OTC MONOGRAPH NOT FINAL part334 Preferred Plus (Kinray) SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 61715-038_9f475ecc-453d-477c-a44d-23402a2423ac 61715-038 HUMAN OTC DRUG Stimulant Laxative Enteric Coated Bisacodyl TABLET, COATED ORAL 20100713 OTC MONOGRAPH NOT FINAL part334 Preferred Plus (Kinray) BISACODYL 5 mg/1 N 20181231 61715-039_61b2d4b2-2252-46e1-bb5d-e017c3fcf618 61715-039 HUMAN OTC DRUG WOMENS GENTLE LAXATIVE Bisacodyl TABLET, COATED ORAL 20100802 OTC MONOGRAPH NOT FINAL part334 Preferred Plus (Kinray) BISACODYL 5 mg/1 N 20181231 61715-040_dd417517-9abb-4412-a7f3-cf30a46f5a3e 61715-040 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20130331 OTC MONOGRAPH FINAL part343 Preferred Plus (Kinray) ASPIRIN 81 mg/1 N 20181231 61715-041_dcb87df9-8505-4189-ba68-a0035446138a 61715-041 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine HCl TABLET ORAL 20101026 OTC MONOGRAPH FINAL part336 Preferred Plus (Kinray) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 61715-042_f8fb3a86-3773-47e0-af6d-9404a5736f96 61715-042 HUMAN OTC DRUG Day Time Cold and Flu Multi-Symptom Relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130331 OTC MONOGRAPH FINAL part341 Preferred Plus (Kinray) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 61715-043_4b4dc419-4f75-4921-bca4-b3ab7217607f 61715-043 HUMAN OTC DRUG Nite-Time Cold and Flu Multi-Symptom Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20130331 OTC MONOGRAPH FINAL part341 Preferred Plus (Kinray) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 61715-044_511ee232-6e7b-4a87-8a61-c41a0321756c 61715-044 HUMAN OTC DRUG Nasal Decongestant PE Maximum Strength Phenylephrine Hydrochloride TABLET ORAL 20100707 OTC MONOGRAPH FINAL part341 Preferred Plus (Kinray) PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 61715-045_762d817d-d8cc-4379-adca-35c99bfeec1b 61715-045 HUMAN OTC DRUG Gas Relief Ultra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20100707 OTC MONOGRAPH FINAL part332 Preferred Plus (Kinray) DIMETHICONE 180 mg/1 N 20181231 61715-046_49d4fbaa-2f26-4360-8a72-e8f3925fe030 61715-046 HUMAN OTC DRUG AntiGas Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100713 OTC MONOGRAPH FINAL part332 Preferred Plus (Kinray) DIMETHICONE 125 mg/1 N 20181231 61715-047_7ebe00a6-b1e0-46a9-8fe2-b5af851daa7d 61715-047 HUMAN OTC DRUG Preferred Plus 12 Hour Nasal Extra Moisturizing Oxymetazoline Hydrochloride SPRAY NASAL 20080131 OTC MONOGRAPH FINAL part341 Kinray OXYMETAZOLINE HYDROCHLORIDE 50 mg/100mL E 20171231 61715-048_56013e78-1101-469b-a89c-714dcbe74947 61715-048 HUMAN OTC DRUG Preferred Plus 12 Hour Nasal Original Oxymetazoline Hydrochloride SPRAY NASAL 20080131 OTC MONOGRAPH FINAL part341 Kinray OXYMETAZOLINE HYDROCHLORIDE 50 mg/100mL E 20171231 61715-049_4f8e7ba2-4eb4-4ad3-8ee6-6ff122fed21c 61715-049 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET ORAL 20130331 ANDA ANDA079112 Preferred Plus (Kinray) FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 61715-050_560c02ad-d329-4458-a761-c50d8b737d69 61715-050 HUMAN OTC DRUG MICONAZOLE MICONAZOLE CREAM TOPICAL 20130321 OTC MONOGRAPH FINAL part333C Kinray, Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 61715-051_9b520434-53f2-4ec5-9aa1-5331d30bbabe 61715-051 HUMAN OTC DRUG PREFERRED PLUS MEDICATED LIP BALM MEDICATED LIP BALM STICK TOPICAL 20070228 UNAPPROVED DRUG OTHER Kinray CAMPHOR (SYNTHETIC); MENTHOL; PHENOL 17; 7; 4 mg/g; mg/g; mg/g E 20171231 61715-052_7a7eb443-1cee-4e90-bec2-a34772314547 61715-052 HUMAN OTC DRUG Preferred Plus Extra Strength Pain Relief Acetaminophen TABLET ORAL 20130626 OTC MONOGRAPH NOT FINAL part343 Kinray ACETAMINOPHEN 500 mg/1 N 20181231 61715-053_08db7699-e25d-4d10-9d06-e0b2435a3149 61715-053 HUMAN OTC DRUG Preferred Plus Ibuprofen 200 Ibuprofen TABLET ORAL 20130626 OTC MONOGRAPH NOT FINAL part343 Kinray IBUPROFEN 200 mg/1 N 20181231 61715-054_bdd9b32e-449f-4f1c-9e4c-3dabc5876f31 61715-054 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100830 ANDA ANDA078682 Preferred Plus (Kinray) IBUPROFEN 200 mg/1 N 20181231 61715-055_cf1eef15-fff0-4590-b602-cf28fbe967f8 61715-055 HUMAN OTC DRUG Preferred Plus Complete Allergy Medicine Diphenhydramine Hydrochloride CAPSULE ORAL 20130507 OTC MONOGRAPH FINAL part341 Kinray Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 61715-056_f244464e-5f53-4d51-af45-427cf91a3df0 61715-056 HUMAN OTC DRUG Preferred Plus Senna Gentle Natural Vegetable Laxative Sennosides TABLET, FILM COATED ORAL 20130507 OTC MONOGRAPH NOT FINAL part334 Kinray Inc. SENNOSIDES 8.6 mg/1 N 20181231 61715-057_28835a86-b0f8-400e-9c26-cd077955d640 61715-057 HUMAN OTC DRUG Preferred Plus Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20130511 ANDA ANDA079129 Kinray, Inc. IBUPROFEN 200 mg/1 N 20181231 61715-058_c6eab715-b3a3-40af-bc77-8d3c0c99e007 61715-058 HUMAN OTC DRUG ANTACID Calcium Carbonate TABLET, CHEWABLE ORAL 20130628 OTC MONOGRAPH FINAL part331 Kinray Inc. CALCIUM CARBONATE 500 mg/1 N 20181231 61715-059_24471a0d-6862-475c-9586-e78b4c6897f9 61715-059 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110725 ANDA ANDA091239 Kinray IBUPROFEN 200 mg/1 N 20181231 61715-060_02d3fae4-c0a8-4071-9ac1-8b10028f400c 61715-060 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20091125 ANDA ANDA079096 Kinray NAPROXEN SODIUM 220 mg/1 N 20181231 61715-061_c1b1f1ae-db9d-4326-996b-af018abb687b 61715-061 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110725 ANDA ANDA091239 Kinray IBUPROFEN 200 mg/1 N 20181231 61715-062_3bc89c6b-418f-47dc-89dd-bddaf5bbcb38 61715-062 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20111207 ANDA ANDA077498 Kinray CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 61715-063_c72f6118-d58c-46ae-87b1-107a47113237 61715-063 HUMAN OTC DRUG Famotidine famotidine TABLET, FILM COATED ORAL 20111003 ANDA ANDA090283 Kinray FAMOTIDINE 10 mg/1 N 20181231 61715-064_c72f6118-d58c-46ae-87b1-107a47113237 61715-064 HUMAN OTC DRUG Famotidine famotidine TABLET, FILM COATED ORAL 20120215 ANDA ANDA090283 Kinray FAMOTIDINE 20 mg/1 N 20181231 61715-065_9c184378-29e5-4548-86b5-768ee805dece 61715-065 HUMAN OTC DRUG Preferred Plus TabTussin Guaifenesin TABLET ORAL 20110926 OTC MONOGRAPH FINAL part341 Kinray GUAIFENESIN 400 mg/1 N 20181231 61715-066_77c7e6a8-cae5-4bfc-a8ee-7c50943235aa 61715-066 HUMAN OTC DRUG Preferred Plus TabTussin DM DMTDM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Kinray DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 61715-068_bc7df9c1-3c93-4f84-90d3-51f5ccb491cd 61715-068 HUMAN OTC DRUG Acetaminophen Sinus Congestion and Pain Daytime ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20121228 OTC MONOGRAPH FINAL part341 Kinray Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 61715-069_42bad289-1b1c-4071-818c-073ac880bf8c 61715-069 HUMAN OTC DRUG KPP Triple Action Menthol POWDER TOPICAL 20101031 OTC MONOGRAPH NOT FINAL part348 Cardinal Health, Inc MENTHOL 1 g/100g E 20171231 61715-070_0054707d-476d-4272-98a2-68b519673e46 61715-070 HUMAN OTC DRUG KPP Ultra Thin Corn Removers Salicylic Acid PLASTER TOPICAL 19951031 OTC MONOGRAPH FINAL part358F Cardinal Health SALICYLIC ACID 40 1/1 N 20181231 61715-071_bc3d747b-ef50-43c0-80b5-b077cde3f1d2 61715-071 HUMAN OTC DRUG KPP Ultra Thick Medicated Callus Remover Salicylic Acid PLASTER TOPICAL 19951031 OTC MONOGRAPH FINAL part358F Cardinal Health SALICYLIC ACID 40 1/1 N 20181231 61715-072_e193543e-cd2a-4a9d-af49-b351a5017f66 61715-072 HUMAN OTC DRUG Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% LIQUID TOPICAL 20130803 NDA NDA019125 Kinray Inc. CHLORHEXIDINE GLUCONATE 4 mg/100mL N 20181231 61715-073_e891cc1e-5a2f-4b83-88bd-d2a2df8288e4 61715-073 HUMAN OTC DRUG Preferred Plus Medicated Baby Active Corn Starch POWDER TOPICAL 20101031 OTC MONOGRAPH FINAL part347 Cardinal Health, Inc STARCH, CORN; ZINC OXIDE; KAOLIN 89.27; 16.95; 4.52 g/113g; g/113g; g/113g E 20171231 61715-074_bf4d3158-769a-4ea0-b3ef-aa9f9b93888e 61715-074 HUMAN OTC DRUG Cough Multi Symptom Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl LIQUID ORAL 20060828 OTC MONOGRAPH FINAL part341 Kinray LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 500; 15; 6.25; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL E 20171231 61715-075_5bce9baa-fe74-4601-845c-f18a435bba45 61715-075 HUMAN OTC DRUG Cough and Sore Throat Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20060828 OTC MONOGRAPH FINAL part341 Kinray LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL E 20171231 61715-076_7964b13c-641f-43f2-971c-cad1eeb10ebf 61715-076 HUMAN OTC DRUG Cough and Sore Throat Daytime Acetaminophen, Dextromethorphan HBr LIQUID ORAL 20060828 OTC MONOGRAPH FINAL part341 Kinray LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 500; 15 mg/15mL; mg/15mL E 20171231 61715-077_cbbea11c-45d2-40ea-90f4-2e29fc45aafa 61715-077 HUMAN OTC DRUG Preferred Plus Intense Cough Reliever Dextromethorphan Hydrobromide / Guaifenesin LIQUID ORAL 20110802 OTC MONOGRAPH FINAL part341 Kinray DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 300 mg/5mL; mg/5mL N 20181231 61715-078_210aa7ca-e242-4abd-98d1-677ce33187fb 61715-078 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SOLUTION ORAL 20140601 20180930 ANDA ANDA074916 Preferred Plus (Kinray) IBUPROFEN 100 mg/5mL N 20181231 61715-079_e55c385f-9c86-4b4e-b9ed-2a44ab6b9d65 61715-079 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20130802 OTC MONOGRAPH FINAL part333B Kinray Inc. BACITRACIN 500 [iU]/g N 20181231 61715-080_9a197e3f-8780-4e8c-912d-9ae8a945fc65 61715-080 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20140315 OTC MONOGRAPH FINAL part347 Preferred Plus (Kinray) DIMETHICONE 125 mg/1 N 20181231 61715-081_42bf42b9-3505-43b5-a06c-47e8824245e3 61715-081 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH NOT FINAL part334 Preferred Plus (Kinray) DOCUSATE SODIUM 100 mg/1 N 20181231 61715-082_51a697e7-f9eb-4f96-8a41-80a941b074d8 61715-082 HUMAN OTC DRUG Anti-Itch Extra Strength Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part348 Preferred Plus (Kinray) DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g N 20181231 61715-083_5f2492c9-8f17-4b65-ba6e-b969a343167d 61715-083 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20131125 OTC MONOGRAPH FINAL part336 Preferred Plus (Kinray) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 61715-084_097430d7-d5ad-4c9c-a700-cd2b47d0d8f3 61715-084 HUMAN OTC DRUG EZ Nite Sleep Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140212 OTC MONOGRAPH FINAL part338 Preferred Plus (Kinray) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 61715-085_40e6e9ab-a557-4547-9ec8-7c1bc22272b6 61715-085 HUMAN OTC DRUG Nicotine Transdermal System Step 1 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Preferred Plus (Kinray) NICOTINE 21 mg/24h E 20171231 61715-086_40e6e9ab-a557-4547-9ec8-7c1bc22272b6 61715-086 HUMAN OTC DRUG Nicotine Transdermal System Step 2 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Preferred Plus (Kinray) NICOTINE 14 mg/24h E 20171231 61715-087_40e6e9ab-a557-4547-9ec8-7c1bc22272b6 61715-087 HUMAN OTC DRUG Nicotine Transdermal System Step 3 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Preferred Plus (Kinray) NICOTINE 7 mg/24h E 20171231 61715-089_9dacb085-8749-43cc-9bb9-18629c24f6c9 61715-089 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20140127 ANDA ANDA200536 Preferred Plus (Kinray) RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 61715-090_579aeee0-14b3-44b1-a8ae-7b2b38ec1edb 61715-090 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20140127 ANDA ANDA201745 Preferred Plus (Kinray) RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 61715-091_98ee5b75-5008-42c8-bc5f-659df6ad9af9 61715-091 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140318 ANDA ANDA077958 Kinray Inc. KETOTIFEN FUMARATE .35 mg/mL N 20181231 61715-092_0420cf01-6105-4f03-b207-de025fbc6fb5 61715-092 HUMAN OTC DRUG Preferred Plus Hemorrhoid Glycerin, Petrolatum, Phenylephrine Hydrochloride, Pramoxine Hydrochloride CREAM RECTAL 20140328 OTC MONOGRAPH FINAL part346 Kinray, Inc. GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE 144; 150; 2.5; 10 mg/L; mg/L; mg/L; mg/L N 20191231 61715-093_6ab18751-ff99-4dbb-a4d8-ec821f86acf1 61715-093 HUMAN OTC DRUG Preferred Plus Hemorrhoidal phenylephrine hydrochloride, witch hazel CREAM RECTAL 20140328 OTC MONOGRAPH FINAL part346 Kinray Inc. PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 2.5; 500 mg/L; mg/L N 20191231 61715-097_938a7733-c981-488e-a53a-f67bebcea0d0 61715-097 HUMAN OTC DRUG Allergy Relief Eye Drops Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140318 ANDA ANDA077958 Kinray Inc. KETOTIFEN FUMARATE .35 mg/mL N 20181231 61715-098_a632e4f5-0911-43db-bc9b-c7e07b4e5b5b 61715-098 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20140425 ANDA ANDA079096 Kinray LLC NAPROXEN SODIUM 220 mg/1 N 20181231 61715-099_7abf1fe7-f328-4edf-a7cf-ca83a1c505f7 61715-099 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20140425 ANDA ANDA079096 Kinray LLC NAPROXEN SODIUM 220 mg/1 N 20181231 61715-100_ac9e7959-f8cd-4584-8def-d130916ef68f 61715-100 HUMAN OTC DRUG Acetaminophen PM Rapid Release Acetaminophen and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20140425 OTC MONOGRAPH FINAL part341 Kinray LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 61715-101_e31ff4e7-8443-439b-bb65-fc5a3a2961de 61715-101 HUMAN OTC DRUG Acetaminophen Rapid Release Acetaminophen TABLET, COATED ORAL 20140425 OTC MONOGRAPH NOT FINAL part343 Kinray LLC ACETAMINOPHEN 500 mg/1 N 20181231 61715-102_4dd05339-31a3-4ea5-9fbe-0e375bf2ca99 61715-102 HUMAN OTC DRUG Kinray Vitamin A D Petrolatum OINTMENT TOPICAL 20140310 OTC MONOGRAPH FINAL part347 Kinray Inc. PETROLATUM .76 g/g N 20181231 61715-103_395dde5c-2b49-4b93-b602-551c4262fd55 61715-103 HUMAN OTC DRUG Preferred Plus Sinus Pseudoephedrine HCl TABLET, FILM COATED ORAL 20140609 OTC MONOGRAPH FINAL part341 Kinray PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 61715-104_066c8c31-9f81-43c1-91d4-d13cf5b720f9 61715-104 HUMAN OTC DRUG preferred plus arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140922 ANDA ANDA075077 Kinray ACETAMINOPHEN 650 mg/1 N 20181231 61715-105_e91a8a0a-fe82-443c-a8c4-afac601d1aaf 61715-105 HUMAN OTC DRUG Preferred Plus Aller Ease fexofenadine hcl TABLET, FILM COATED ORAL 20140617 ANDA ANDA076447 Kinray FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 61715-108_b3856a6a-1a9c-4a20-8610-90083c77bd0e 61715-108 HUMAN OTC DRUG Preferred Plus Loperamide Hydrochloride loperamide HCl SUSPENSION ORAL 20140609 ANDA ANDA091292 Kinray LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20191231 61715-109_535969d5-ad09-41a5-a1f4-073e086c1bfa 61715-109 HUMAN OTC DRUG Preferred Plus Loperamide Hydrochloride Loperamide HCl TABLET, FILM COATED ORAL 20140527 ANDA ANDA075232 Kinray LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 61715-111_33c9f9ab-b5e2-4ab6-b5f8-ae812144ec72 61715-111 HUMAN OTC DRUG Preferred Plus Severe Nite Time Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20140717 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 61715-112_f10d207d-91f9-4831-bce2-846ecf847c46 61715-112 HUMAN OTC DRUG Preferred Plus Severe Day Time acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20140717 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 61715-113_ac9c79eb-96ba-4086-9f51-53b3f74f0b1a 61715-113 HUMAN OTC DRUG preferred plus cough dm dextromethorphan polistirex SUSPENSION ORAL 20141003 ANDA ANDA091135 Kinray DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 61715-116_194b0314-6859-479d-9c69-a406a1a117e8 61715-116 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20141031 OTC MONOGRAPH NOT FINAL part356 Preferred Plus (Kinray) PHENOL 1.4 g/100mL N 20181231 61715-117_4ad672cd-b7aa-4a9c-86a2-402b3acd04ed 61715-117 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20141031 OTC MONOGRAPH NOT FINAL part356 Preferred Plus (Kinray) PHENOL 1.4 g/100mL N 20181231 61715-118_be18ebf7-1959-4b7e-b23d-fb3c9233592d 61715-118 HUMAN OTC DRUG Preferred Plus Allergy Relief Loratadine TABLET ORAL 20140922 ANDA ANDA076301 Kinray LORATADINE 10 mg/1 N 20181231 61715-119_d00142ca-700b-42af-a5bd-432268ba4de8 61715-119 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20150531 OTC MONOGRAPH NOT FINAL part356 Preferred Plus (Kinray) HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 61715-122_7ba2bcce-099a-407c-9248-399360c1fe95 61715-122 HUMAN OTC DRUG Preferred Plus All Day Allergy Cetirizine Hydrochloride TABLET ORAL 20140922 ANDA ANDA078336 Kinray CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 61715-123_26d5b80b-a7f4-4b7b-b715-dc012dc7fc38 61715-123 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20150531 OTC MONOGRAPH NOT FINAL part333A Preferred Plus (Kinray) ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 61715-124_1510a11c-871d-4293-8c98-f9779af1102d 61715-124 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20150531 OTC MONOGRAPH NOT FINAL part333A Preferred Plus (Kinray) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 61715-129_90609e91-6dea-4279-ac2e-b1f676368083 61715-129 HUMAN OTC DRUG Fiber Therapy Regular Flavor Psyllium Dietary Fiber Supplement GRANULE, FOR SOLUTION ORAL 20140928 OTC MONOGRAPH NOT FINAL part334 Kinray LLC PSYLLIUM HUSK 3.4 g/5.4g E 20171231 61715-130_90e8a135-fabc-4e02-8857-ff4ad40de1a8 61715-130 HUMAN OTC DRUG Fiber Therapy Orange Flavor Psyllium Dietary Fiber Supplement GRANULE, FOR SOLUTION ORAL 20140928 OTC MONOGRAPH NOT FINAL part334 Kinray LLC PSYLLIUM HUSK 3.4 g/5.4g E 20171231 61715-131_4fa9508a-e960-4ff8-8439-4689a93d8eb2 61715-131 HUMAN OTC DRUG Milk of Magnesia Magnesium hydroxide LIQUID ORAL 20141001 OTC MONOGRAPH NOT FINAL part334 Kinray LLC MAGNESIUM HYDROXIDE 400 mg/5mL E 20171231 61715-138_0835faba-4b14-430e-91ac-35198d476347 61715-138 HUMAN OTC DRUG preferred plus childrens mucus relief multi symptom cold dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20150508 OTC MONOGRAPH FINAL part341 Kinray DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 61715-144_dcc6ac47-c13b-4acf-8728-f94613a1fb4d 61715-144 HUMAN OTC DRUG Preferred Plus Cold and Flu Night Time Acetaminophen, diphenhydramine HCl, phenylephrine HCl TABLET, FILM COATED ORAL 20141203 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 61715-147_d0d09883-4cdf-4265-923c-10a7a968b448 61715-147 HUMAN OTC DRUG preferred plus severe cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20141203 OTC MONOGRAPH FINAL part341 Kinray ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 61715-150_e835dda7-e5a6-4a65-9b00-acb51df5d617 61715-150 HUMAN OTC DRUG Preferred Plus ClearLax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20141120 ANDA ANDA090685 Kinray POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 61715-151_30562cee-bd9f-4e24-af4b-1d7d9e0fa017 61715-151 HUMAN OTC DRUG Preferred Plus Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20141020 NDA NDA022032 Kinray OMEPRAZOLE 20 mg/1 N 20181231 61715-152_94d64de5-d225-43ff-bc33-bc59eb35c9ea 61715-152 HUMAN OTC DRUG Preferred Plus Nasal oxymetazoline hydrochloride SPRAY NASAL 20141124 OTC MONOGRAPH FINAL part341 Kinray OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 61715-153_e9be22b7-5925-443c-9572-813449cf49f5 61715-153 HUMAN OTC DRUG Preferred Plus Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20141124 OTC MONOGRAPH FINAL part341 Kinray OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 61715-154_0c1edd18-e51a-4749-9c73-b7f6f5e9beeb 61715-154 HUMAN OTC DRUG Isopropyl alcohol 70 percent Wintergreen Isopropyl alcohol LIQUID TOPICAL 20150531 OTC MONOGRAPH NOT FINAL part333A Preferred Plus (Kinray) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 61715-155_595d95a6-f34d-49ca-9efb-1c2b87116013 61715-155 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20150531 OTC MONOGRAPH FINAL part347 Preferred Plus (Kinray) WITCH HAZEL 842 mg/mL N 20181231 61715-156_06d35dd6-49fe-4519-b8f1-d9de9c19273b 61715-156 HUMAN OTC DRUG Preferred Plus (Kinray) Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Preferred Plus (Kinray) LORATADINE 5 mg/5mL N 20181231 61715-157_18d8d3aa-6715-45d3-a7c5-76c7aecdbf59 61715-157 HUMAN OTC DRUG Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Preferred Plus (Kinray) CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 61715-158_123ef988-b730-4ae2-a7d5-6f992d52c69e 61715-158 HUMAN OTC DRUG Preferred Plus Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Preferred Plus (Kinray) TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 61715-161_188fcb7f-2b32-41ef-91c7-834d317a96c2 61715-161 HUMAN OTC DRUG Anti-Itch Extra Strength Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part348 Preferred Plus (Kinray) DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; 1 mg/g; mg/g E 20171231 61715-163_e13f7dc3-d273-4727-8037-c292ff34d328 61715-163 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL; TOPICAL 20150630 OTC MONOGRAPH NOT FINAL part334 Preferred Plus (Kinray) MINERAL OIL 100 mg/100mL N 20181231 61715-167_0eec0d43-3b21-4150-901a-f520888aab22 61715-167 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20160301 ANDA ANDA091239 Kinray, Inc. IBUPROFEN 200 mg/1 N 20181231 61715-168_401191fe-7ed4-468c-98cc-e00f2c0bcc64 61715-168 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20160301 ANDA ANDA091237 Kinray, Inc. IBUPROFEN 200 mg/1 N 20181231 61715-170_dfba1f38-9354-4790-917f-8a72f1e69f82 61715-170 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20160531 OTC MONOGRAPH NOT FINAL part334 Preferred Plus (Kinray) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 61715-171_3bb43712-e06d-40a6-a89a-3319c1a5d7fc 61715-171 HUMAN OTC DRUG Ear Wax Removal Drops Preferred Plus Pharmacy Carbamide Peroxide - 6.5% SOLUTION/ DROPS TOPICAL 20140609 OTC MONOGRAPH FINAL part344 Kinray CARBAMIDE PEROXIDE 65 mg/mL N 20181231 61715-253_486e4354-2d29-454d-e054-00144ff8d46c 61715-253 HUMAN OTC DRUG Preferred Plus Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20101028 OTC MONOGRAPH FINAL part358G Kinray PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 61722-001_fc029a79-0558-4f7a-aeda-4799982154eb 61722-001 HUMAN OTC DRUG flormar BB Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 01 Light OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-002_23ffedd0-2407-4cca-8aee-d57299b3035b 61722-002 HUMAN OTC DRUG flormar BB Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 02 Light Medium OCTINOXATE CREAM TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-003_747dbae5-afe0-4f38-81a5-3d25c529be1d 61722-003 HUMAN OTC DRUG flormar BB Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 03 Dark Medium OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-004_89f48832-9646-4533-9f46-1412929acf75 61722-004 HUMAN OTC DRUG flormar BB Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 04 Medium Beige OCTINOXATE CREAM TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-005_5f038453-8385-4aa0-9b54-8c68f89f0791 61722-005 HUMAN OTC DRUG flormar BB Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 05 Neutral Beige OCTINOXATE CREAM TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-006_bda2e7f6-7401-4ed9-be77-8af5b8624325 61722-006 HUMAN OTC DRUG flormar BB Sheer Tinted Beauty Sunscreen Broad Spectrum SPF 15 06 Warm Beige OCTINOXATE CREAM TOPICAL 20140612 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-020_d1e3fc2e-b59c-470f-8d2e-6a2f440f887c 61722-020 HUMAN OTC DRUG flormar ADVICE Skin Geometry Day Sunscreen Broad Spectrum SPF 15 AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 15; 40; 20 mg/mL; mg/mL; mg/mL N 20181231 61722-021_9c63fc03-b55d-4ebf-bad6-11506e0d5598 61722-021 HUMAN OTC DRUG flormar ADVICE Skin Geometry Purely Moisturizing Day Sunscreen Broad Spectrum SPF 15 Dry and Sensitive Skin AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20140613 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 15; 40; 20 mg/mL; mg/mL; mg/mL N 20181231 61722-022_ce1e6dfe-df49-4034-9f9c-d9a19f368dd5 61722-022 HUMAN OTC DRUG flormar ADVICE Skin Geometry Purely Moisturizing Day Sunscreen Broad Spectrum SPF 15 Normal and Combination Skin AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 15; 40; 20 mg/mL; mg/mL; mg/mL N 20181231 61722-023_a68834d0-cb57-4552-a7ea-04ca4cbcb536 61722-023 HUMAN OTC DRUG flormar REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10 OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-040_6abf33fc-b36d-4026-8aa5-24325a40a321 61722-040 HUMAN OTC DRUG flormar Concealer Sunscreen Broad Spectrum SPF 20 LC01 PURE BEIGE OCTINOXATE CREAM TOPICAL 20140618 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-041_31ba0c66-5ed5-4c54-9d6a-e805187c9e0a 61722-041 HUMAN OTC DRUG flormar Concealer Sunscreen Broad Spectrum SPF 20 LC03 SOFT HONEY OCTINOXATE CREAM TOPICAL 20140618 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-042_d3df7524-d722-4290-b61e-0fa2b1dc8bb3 61722-042 HUMAN OTC DRUG flormar Concealer Sunscreen Broad Spectrum SPF 20 LC05 CAPPUCCINO OCTINOXATE CREAM TOPICAL 20140618 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-043_694b95e8-0924-48ce-ac71-dedd99f47aba 61722-043 HUMAN OTC DRUG flormar Concealer Sunscreen Broad Spectrum SPF 20 LC07 NATURAL BEIGE OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-060_d66f5bf1-377f-4704-819f-3c9a854b55ee 61722-060 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF01 PORCELAIN OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-061_5b461d91-a723-4313-b491-0f9db21f6354 61722-061 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF04 SOFT IVORY OCTINOXATE CREAM TOPICAL 20140618 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-062_18708174-8bdf-4729-b659-f5a03f236398 61722-062 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF07 IVORY OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-063_f41abb8e-d89c-413c-b888-dd997e019876 61722-063 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF10 SAND BEIGE OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-064_60efbd8f-6d04-4ffe-9f40-1d54a7388f1f 61722-064 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF13 GOLDEN BEIGE OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-065_35c5b90b-6d16-4b18-9213-ce4a9e39fe43 61722-065 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF16 NATURAL BEIGE OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-066_ea34c4d0-0166-4edd-b9b9-90ca59acd7ec 61722-066 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF19 BEIGE OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-067_848be030-f970-47e6-bb92-29e0f9a23568 61722-067 HUMAN OTC DRUG flormar Foundation Sunscreen Broad Spectrum SPF 20 LF22 PURE BEIGE OCTINOXATE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-080_55387018-2218-4aaa-8606-528b72a34bf8 61722-080 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 101 Pastelle OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-081_b755b2a7-8980-4fa3-b1c3-d44256441486 61722-081 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 102 Soft Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-082_332e6e80-7949-470a-a4ad-c75ec539fe9f 61722-082 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 103 Creamy Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-083_e9d8db12-4cdf-48f3-aa43-5504199af038 61722-083 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 104 Vanille Eclat OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-084_8d64307c-71c7-4bc8-8f03-b3b2fce2237a 61722-084 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 105 Porcelain Ivory OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-085_42730151-9512-43ca-b0e2-073cf2e06c2c 61722-085 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 106 Classic Ivory OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-086_efafe4ce-239d-4a17-909c-cd663221d4a8 61722-086 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 107 Natural Ivory OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-087_83b37afa-c87d-499f-a0d3-a0a456c4ff20 61722-087 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 108 Honey OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-088_710eeb74-efd3-4519-83af-8ad945328bce 61722-088 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 113 Medium Beige OCTINOXATE CREAM TOPICAL 20140721 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-089_df029a7a-9ec7-4531-a007-8be706f85f70 61722-089 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 114 Light Beige OCTINOXATE CREAM TOPICAL 20140721 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-090_cf5373b4-8492-4246-8de0-3daa331daf57 61722-090 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 116 Deep Tan OCTINOXATE CREAM TOPICAL 20140721 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-091_1afdbf5e-7ed4-48ac-bb1d-b78c14b4403b 61722-091 HUMAN OTC DRUG flormar PERFECT COVERAGE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 119 Cocoa OCTINOXATE CREAM TOPICAL 20140721 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-140_21987bc3-3f60-4477-b547-c47deb88e8d1 61722-140 HUMAN OTC DRUG flormar CC Magical Color Effect Color Correcting Cream Sunscreen Broad Spectrum SPF 15 CC02 OCTINOXATE CREAM TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-141_8b0aa06b-1ecf-4b3d-8f3c-5eb3ea6d9cb5 61722-141 HUMAN OTC DRUG flormar CC Magical Color Effect Color Correcting Cream Sunscreen Broad Spectrum SPF 15 CC03 OCTINOXATE CREAM TOPICAL 20140708 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-142_28ccd0b8-f7b0-4003-8a3a-871f58869e20 61722-142 HUMAN OTC DRUG flormar CC Magical Color Effect Color Correcting Cream Sunscreen Broad Spectrum SPF 15 CC04 OCTINOXATE CREAM TOPICAL 20140708 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-160_ab4a0b8c-14e2-4d27-a98b-9eac5d7609e8 61722-160 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP01 Rose OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/g N 20181231 61722-161_48f8906a-89b5-4311-b1e6-de631c1a6d2e 61722-161 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP04 Rich Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g N 20181231 61722-162_c6ab5788-fd28-451e-9982-5e458f9981ee 61722-162 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP07 Nude Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g N 20181231 61722-163_3d989e0e-c335-4fd5-9928-006ebdc1b35c 61722-163 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP10 Classic Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g N 20181231 61722-164_2ffd505c-b2e2-4251-b208-49e1a6d7d270 61722-164 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP13 Nude Ivory OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g N 20181231 61722-165_18d9d32f-99df-4526-939a-b45d258c5d84 61722-165 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP16 Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g N 20181231 61722-166_45a9abd6-6827-4bb1-9d76-603e3a4ec3d1 61722-166 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP19 Natural Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g N 20181231 61722-167_5cf18ee0-dff3-4840-ad11-a12f84b8eaab 61722-167 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP21 Soft Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g N 20181231 61722-168_0fde1ae4-7599-4b01-a227-d2abbd360daa 61722-168 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP24 Medium OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g N 20181231 61722-169_5aff246f-2eb6-4f04-bdfe-63c83e8c688e 61722-169 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP27 Capuccino OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g N 20181231 61722-170_bf092282-40d3-44b3-8031-060a000a6928 61722-170 HUMAN OTC DRUG flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP33 Chocolate OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 5 g/100g N 20181231 61722-171_078daff4-71ec-4fa2-84d8-c95411d7a43a 61722-171 HUMAN OTC DRUG FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP30 Caramel OCTINOXATE POWDER TOPICAL 20141024 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/g N 20181231 61722-180_f259bdfe-e15c-49cf-a1ae-9c323b1e99fa 61722-180 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST01 Light Pink OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-181_9f2b234c-9473-4eb8-9bb7-f5e96b87e3c4 61722-181 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST02 Medium Pink OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-182_90df5b6d-400b-4ad0-b520-8372371a6629 61722-182 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST03 Natural Pink OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-183_33e45bd6-c428-4bf4-a209-e2405b91eb20 61722-183 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST04 Medium Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-184_df4abccc-6fee-457c-8217-af0636a4c074 61722-184 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST06 Honey OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-185_b837d035-d336-474c-a4b0-094bab389439 61722-185 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST07 Caramel OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-186_e5b8dcea-a645-4f7b-aa04-43cbc0881636 61722-186 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST08 Bronze Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-187_388b43b7-e476-43b3-b870-c7a8372f5dfe 61722-187 HUMAN OTC DRUG flormar Soft Touch Foundation Sunscreen Broad Spectrum SPF 20 ST05 Warm Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-200_ca902bf8-9323-4d49-946c-0c35f4b1f211 61722-200 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF01 Rose OCTINOXATE CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-201_a6fa3d2e-9d0c-4734-a901-a6aa65d43166 61722-201 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF04 Rich Beige OCTINOXATE CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-202_18303505-0ce3-4ad2-8652-21a1fe7430c2 61722-202 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF07 Nude Beige OCTINOXATE CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-203_a966ff61-d47d-4297-8047-590a61088364 61722-203 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF10 Classic Beige OCTINOXATE CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-204_985457fe-5f55-4330-9d1c-1dcd95d5f82b 61722-204 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF13 Nude Ivory OCTINOXATE CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-205_c03fabb7-d963-4303-b88d-b88d510169f3 61722-205 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF16 Beige OCTINOXATE CREAM TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-206_22709943-5745-4694-84ca-82a5e62ea7db 61722-206 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF19 Natural Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-207_84fc7edc-9ee9-4145-91fd-50fc9d78ae03 61722-207 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF21 Soft Beige OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-208_7f8f93c2-9a1a-4873-8527-dcf3c0e420b1 61722-208 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF24 Medium OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-209_87f93ad6-c4c1-4bdb-8969-b76d0551f28a 61722-209 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF27 Capuccino OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-210_28592e5d-8166-4d59-8d84-d938b1480a70 61722-210 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF30 Caramel OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-211_a4e31faa-358a-475f-a648-f248d9f9c5e4 61722-211 HUMAN OTC DRUG flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF33 Chocolate OCTINOXATE CREAM TOPICAL 20140706 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-220_72369fdd-9528-4aad-97bb-760f4e907d84 61722-220 HUMAN OTC DRUG FLORMAR RADIANT PINK SKIN HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20141107 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 30; 75; 10 mg/mL; mg/mL; mg/mL N 20181231 61722-230_52173db7-5f0a-4536-95ec-36cf49e8845b 61722-230 HUMAN OTC DRUG flormar Delicious Lipstick Stylo Sunscreen Broad Spectrum SPF 15 DS03 Doll Photomontage TITANIUM DIOXIDE STICK TOPICAL 20141217 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g N 20181231 61722-231_36cfa3e7-2303-468b-a207-55c95a60f934 61722-231 HUMAN OTC DRUG Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS04 Surrealist Orchid TITANIUM DIOXIDE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g N 20181231 61722-232_acb3650a-ca96-464e-8095-a99dbc9b6044 61722-232 HUMAN OTC DRUG Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS05 Portrait of a Plum TITANIUM DIOXIDE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g N 20181231 61722-233_b8d82f84-c448-429d-ad89-7a94d8e7fe89 61722-233 HUMAN OTC DRUG Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS06 Yeah it s Yellow TITANIUM DIOXIDE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g N 20181231 61722-234_7726957a-76c0-4026-8de7-10971a2db922 61722-234 HUMAN OTC DRUG Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS07 Cubic Sun TITANIUM DIOXIDE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g N 20181231 61722-235_a1e4c099-e90f-4aa9-a64e-525ee318be5a 61722-235 HUMAN OTC DRUG Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS08 Futuristic Orange TITANIUM DIOXIDE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g N 20181231 61722-236_ca677322-1992-46e3-b2b2-68e09afaee09 61722-236 HUMAN OTC DRUG Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS09 Delicious Abstract Melon TITANIUM DIOXIDE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g N 20181231 61722-237_3ed3e69f-27f7-47b2-b826-0e7feb1030de 61722-237 HUMAN OTC DRUG Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS10 Collage of Citrus TITANIUM DIOXIDE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g N 20181231 61722-238_d5093bed-9ca0-4473-a6d0-fe20d00106d6 61722-238 HUMAN OTC DRUG Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS12 Alter Ego TITANIUM DIOXIDE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g N 20181231 61722-239_dabff3ac-a300-4f12-bc71-b14c758940b0 61722-239 HUMAN OTC DRUG Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS14 Rise of Modern City TITANIUM DIOXIDE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g N 20181231 61722-240_6021b6ac-c2ff-4f04-9daa-bd0de58850e0 61722-240 HUMAN OTC DRUG Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS15 The Day Before Jury TITANIUM DIOXIDE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g N 20181231 61722-241_fb2942da-c308-4e20-9181-d5f59c284032 61722-241 HUMAN OTC DRUG Flormar Delicious Lip Stylo Sunscreen Broad Spectrum SPF 15 DS16 Meet So Black TITANIUM DIOXIDE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. TITANIUM DIOXIDE 20 mg/g N 20181231 61722-250_28aa4142-b3ff-4814-af85-d10431071c7f 61722-250 HUMAN OTC DRUG Flormar Lip Moisturizer Apple Sunscreen Stick Broad Spectrum SPF 15 OCTINOXATE LIPSTICK TOPICAL 20141223 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi Ve Ticaret A.S. OCTINOXATE 69 mg/g N 20181231 61722-251_826aa1d0-a842-44aa-a087-cac88a56dec7 61722-251 HUMAN OTC DRUG Flormar Lip Moisturizer Watermelon Sunscreen Stick Broad Spectrum SPF 15 OCTINOXATE LIPSTICK TOPICAL 20141223 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi Ve Ticaret A.S. OCTINOXATE 68 mg/g N 20181231 61722-252_3e263a77-251e-4edb-ba5b-d1211754af01 61722-252 HUMAN OTC DRUG Flormar Lip Moisturizer Orange Sunscreen Broad Spectrum SPF 15 OCTINOXATE STICK TOPICAL 20150129 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 68 mg/g N 20181231 61722-253_de97213f-7f08-46e7-8e63-e8ffc1ddd82d 61722-253 HUMAN OTC DRUG Flormar Lip Moisturizer Cream Carmel Sunscreen Broad Spectrum SPF 15 OCTINOXATE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 68 mg/g N 20181231 61722-254_a281d503-0e37-408a-96a7-be913430e1cd 61722-254 HUMAN OTC DRUG Flormar Lip Moisturizer Strawberry Sunscreen Broad Spectrum SPF 15 OCTINOXATE STICK TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 68 mg/g N 20181231 61722-260_20d080d9-5fa7-2d3a-e054-00144ff88e88 61722-260 HUMAN OTC DRUG Flormar Perfect Coverage Foundation 115 Toffee OCTINOXATE CREAM TOPICAL 20150927 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-261_20d080fd-50b1-310f-e054-00144ff88e88 61722-261 HUMAN OTC DRUG Flormar Perfect Coverage Foundation 118 Dark Brown OCTINOXATE CREAM TOPICAL 20150927 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-262_20d080fd-50c0-310f-e054-00144ff88e88 61722-262 HUMAN OTC DRUG Flormar Perfect Coverage Foundation 117 Dark Caramel OCTINOXATE CREAM TOPICAL 20150927 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 10 mg/mL N 20181231 61722-270_2bd2cc01-b160-4837-e054-00144ff8d46c 61722-270 HUMAN OTC DRUG Flormar Smooth Touch Foundation 01 Porcelain OCTINOXATE AEROSOL TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-271_2bd2cc01-b17e-4837-e054-00144ff8d46c 61722-271 HUMAN OTC DRUG Flormar Smooth Touch Foundation 02 Pink Porcelain OCTINOXATE AEROSOL TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-272_2bd2cc01-b16f-4837-e054-00144ff8d46c 61722-272 HUMAN OTC DRUG Flormar Smooth Touch Foundation 03 Light Ivory OCTINOXATE AEROSOL TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-273_2bd2cf47-5f57-67fe-e054-00144ff88e88 61722-273 HUMAN OTC DRUG Flormar Smooth Touch Foundation 04 Ivory OCTINOXATE AEROSOL TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-274_2bd2cf47-5f48-67fe-e054-00144ff88e88 61722-274 HUMAN OTC DRUG Flormar Smooth Touch Foundation 05 Soft Beige OCTINOXATE AEROSOL TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-275_2bd2cc01-b18d-4837-e054-00144ff8d46c 61722-275 HUMAN OTC DRUG Flormar Smooth Touch Foundation 06 Beige OCTINOXATE AEROSOL TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-276_2bd2cc01-b1af-4837-e054-00144ff8d46c 61722-276 HUMAN OTC DRUG Flormar Smooth Touch Foundation 07 Golden Neutral OCTINOXATE AEROSOL TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-277_2bd1a50d-b511-0984-e054-00144ff8d46c 61722-277 HUMAN OTC DRUG Flormar Smooth Touch Foundation 08 Medium Beige OCTINOXATE AEROSOL TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-278_2bd2cf47-5f27-67fe-e054-00144ff88e88 61722-278 HUMAN OTC DRUG Flormar Smooth Touch Foundation 09 Golden Beige OCTINOXATE AEROSOL TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-279_2bd29f6d-edec-4182-e054-00144ff8d46c 61722-279 HUMAN OTC DRUG Flormar Smooth Touch Foundation 10 Sand OCTINOXATE AEROSOL TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-280_2bd2cf47-5f36-67fe-e054-00144ff88e88 61722-280 HUMAN OTC DRUG Flormar Smooth Touch Foundation 11 Honey OCTINOXATE AEROSOL TOPICAL 20160214 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-281_2bd2e748-bac5-6ad9-e054-00144ff88e88 61722-281 HUMAN OTC DRUG Flormar Smooth Touch Foundation 12 Amber OCTINOXATE AEROSOL TOPICAL 20160214 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-282_2bd2cc01-b19c-4837-e054-00144ff8d46c 61722-282 HUMAN OTC DRUG Flormar Smooth Touch Foundation 13 Caramel OCTINOXATE AEROSOL TOPICAL 20160214 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-283_2bd2cf47-5f6a-67fe-e054-00144ff88e88 61722-283 HUMAN OTC DRUG Flormar Smooth Touch Foundation 14 Dark Caramel OCTINOXATE AEROSOL TOPICAL 20160214 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL E 20171231 61722-290_31df8f9d-0713-2bb1-e054-00144ff88e88 61722-290 HUMAN OTC DRUG Flormar BB White BW01 Light OCTINOXATE, OCTOCRYLENE, AVOBENZONE AEROSOL TOPICAL 20160502 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 20; 10 mg/mL; mg/mL; mg/mL E 20171231 61722-291_31df8f9d-0704-2bb1-e054-00144ff88e88 61722-291 HUMAN OTC DRUG Flormar BB White BW02 Light Medium OCTINOXATE, OCTOCRYLENE, AVOBENZONE AEROSOL TOPICAL 20160502 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 20; 10 mg/mL; mg/mL; mg/mL E 20171231 61722-292_31df8f9d-0722-2bb1-e054-00144ff88e88 61722-292 HUMAN OTC DRUG Flormar BB White BW03 Dark Medium OCTINOXATE, OCTOCRYLENE, AVOBENZONE AEROSOL TOPICAL 20160502 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 20; 10 mg/mL; mg/mL; mg/mL E 20171231 61722-293_31df8f9d-0740-2bb1-e054-00144ff88e88 61722-293 HUMAN OTC DRUG Flormar BB White BW04 Medium Beige OCTINOXATE, OCTOCRYLENE, AVOBENZONE AEROSOL TOPICAL 20160502 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 20; 10 mg/mL; mg/mL; mg/mL E 20171231 61722-294_31dfc25b-e20a-0ea0-e054-00144ff8d46c 61722-294 HUMAN OTC DRUG Flormar BB White BW05 Natural Beige OCTINOXATE, OCTOCRYLENE, AVOBENZONE AEROSOL TOPICAL 20160502 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 20; 10 mg/mL; mg/mL; mg/mL E 20171231 61722-295_31df8f9d-0731-2bb1-e054-00144ff88e88 61722-295 HUMAN OTC DRUG Flormar BB White BW06 Warm Beige OCTINOXATE, OCTOCRYLENE, AVOBENZONE AEROSOL TOPICAL 20160502 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 20; 10 mg/mL; mg/mL; mg/mL E 20171231 61722-296_394381ee-584b-552b-e054-00144ff8d46c 61722-296 HUMAN OTC DRUG Flormar Blur Effect BB Sunscreen Broad Spectrum SPF 30 01 Light OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20160802 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 20; 10 mg/mL; mg/mL; mg/mL E 20171231 61722-297_3943d3c1-d94e-41fe-e054-00144ff88e88 61722-297 HUMAN OTC DRUG Flormar Blur Effect BB Sunscreen Broad Spectrum SPF 30 02 Light Medium OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20160802 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 20; 10 mg/mL; mg/mL; mg/mL E 20171231 61722-298_3943d3c1-d95d-41fe-e054-00144ff88e88 61722-298 HUMAN OTC DRUG Flormar Blur Effect BB Sunscreen Broad Spectrum SPF 30 03 Dark Medium OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20160802 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE; OCTOCRYLENE; AVOBENZONE 50; 20; 10 mg/mL; mg/mL; mg/mL E 20171231 61722-300_5acb9653-54a6-1b69-e053-2a91aa0aafb3 61722-300 HUMAN OTC DRUG Pretty by Flormar BB 001 Light OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-301_5acb9a2f-0fac-4929-e053-2a91aa0ae6d5 61722-301 HUMAN OTC DRUG Pretty by Flormar BB 002 Light Medium OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-302_53988fd6-52ed-74a9-e054-00144ff8d46c 61722-302 HUMAN OTC DRUG Pretty by Flormar BB 003 Dark Medium OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-303_53988090-5eda-70a8-e054-00144ff8d46c 61722-303 HUMAN OTC DRUG Pretty by Flormar BB 004 Medium Beige OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-304_53988090-5eec-70a8-e054-00144ff8d46c 61722-304 HUMAN OTC DRUG Pretty by Flormar BB 005 Natural Beige OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-305_52557cd0-d14c-683a-e054-00144ff88e88 61722-305 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 001 Porcelain OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-306_52557b02-96e9-2b43-e054-00144ff8d46c 61722-306 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 002 Pink Porcelain OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-307_52557b02-96f8-2b43-e054-00144ff8d46c 61722-307 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 003 Light Ivory OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-308_52557b02-9707-2b43-e054-00144ff8d46c 61722-308 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 004 Ivory OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-309_5255c4d1-0668-3c19-e054-00144ff8d46c 61722-309 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 005 Soft Beige OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-310_52557b02-9716-2b43-e054-00144ff8d46c 61722-310 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 006 Beige OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-311_52557b02-9725-2b43-e054-00144ff8d46c 61722-311 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 007 Neutral OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-312_5255c4d1-069b-3c19-e054-00144ff8d46c 61722-312 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 008 Medium Beige OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-313_5255c4d1-06aa-3c19-e054-00144ff8d46c 61722-313 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 009 Golden Beige OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-314_5255d191-2455-0351-e054-00144ff88e88 61722-314 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 010 Sand OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-315_5255c4d1-06bb-3c19-e054-00144ff8d46c 61722-315 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 011 Honey OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-316_5255d191-2464-0351-e054-00144ff88e88 61722-316 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 012 Amber OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-317_5255d191-2473-0351-e054-00144ff88e88 61722-317 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 013 Caramel OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-318_5255ce83-1b4f-3c17-e054-00144ff8d46c 61722-318 HUMAN OTC DRUG Pretty by Flormar Cover up Foundation 014 Dark Caramel OCTINOXATE CREAM TOPICAL 20170617 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-319_5254dad4-d9c4-0cbc-e054-00144ff8d46c 61722-319 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 001 Porcelain OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-320_52557d97-5086-6846-e054-00144ff88e88 61722-320 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 002 Pink Porcelain OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-321_52557cd0-d0c4-683a-e054-00144ff88e88 61722-321 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 003 Light Ivory OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-322_52557cd0-d0d5-683a-e054-00144ff88e88 61722-322 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 004 Ivory OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-323_52656781-1f7f-4d88-e054-00144ff8d46c 61722-323 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 005 Soft Beige OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-324_52656781-1f8e-4d88-e054-00144ff8d46c 61722-324 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 006 Beige OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-325_52557cd0-d0fa-683a-e054-00144ff88e88 61722-325 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 007 Neutral OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-326_52557d97-5095-6846-e054-00144ff88e88 61722-326 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 008 Medium Beige OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-327_52557cd0-d109-683a-e054-00144ff88e88 61722-327 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 009 Golden Beige OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-328_52558ffd-aa97-2cea-e054-00144ff8d46c 61722-328 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 010 Sand OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-329_52557b02-96cb-2b43-e054-00144ff8d46c 61722-329 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 011 Honey OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-330_52557b02-96da-2b43-e054-00144ff8d46c 61722-330 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 012 Amber OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-331_52557cd0-d11d-683a-e054-00144ff88e88 61722-331 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 013 Caramel OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-332_52557cd0-d12c-683a-e054-00144ff88e88 61722-332 HUMAN OTC DRUG Pretty by Flormar Mattifying Foundation 014 Dark Caramel OCTINOXATE CREAM TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-333_52656781-1f9d-4d88-e054-00144ff8d46c 61722-333 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 001Porcelain OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-334_5269f1d1-93a0-3ec2-e054-00144ff8d46c 61722-334 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 002 Pink Porcelain OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-335_52656781-1fac-4d88-e054-00144ff8d46c 61722-335 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 003 Light Ivory OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-336_52656781-1fbc-4d88-e054-00144ff8d46c 61722-336 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 004 Ivory OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-337_52656781-1fcb-4d88-e054-00144ff8d46c 61722-337 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 005 Soft Beige OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-338_52654847-8e39-1d0e-e054-00144ff88e88 61722-338 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 006 Beige OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-339_52656781-1fdc-4d88-e054-00144ff8d46c 61722-339 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 007 Neutral OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-340_52656781-1feb-4d88-e054-00144ff8d46c 61722-340 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 008 Medium Beige OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-341_52656781-1ffb-4d88-e054-00144ff8d46c 61722-341 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 009 Golden Beige OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-342_52656781-200a-4d88-e054-00144ff8d46c 61722-342 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 010 Sand OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-343_52656781-2019-4d88-e054-00144ff8d46c 61722-343 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 011 Honey OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-344_52656781-2028-4d88-e054-00144ff8d46c 61722-344 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 012 Amber OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-345_52656781-2037-4d88-e054-00144ff8d46c 61722-345 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 013 Caramel OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61722-346_52656781-2046-4d88-e054-00144ff8d46c 61722-346 HUMAN OTC DRUG Pretty by Flormar Weigthless Foundation 014 Dark Caramel OCTINOXATE CREAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 Kosan Kozmetik Sanayi ve Ticaret A.S. OCTINOXATE 50 mg/mL N 20181231 61727-001_2d7816a3-05f7-224f-e054-00144ff88e88 61727-001 HUMAN OTC DRUG MetX MetX SOLUTION/ DROPS ORAL 20160120 UNAPPROVED HOMEOPATHIC Homeocare Laboratories Inc. THYROID, UNSPECIFIED; FUCUS SERRATUS; TRIBASIC CALCIUM PHOSPHATE; GRAPHITE; SODIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; SUS SCROFA PLACENTA; ANTIMONY TRISULFIDE; BOS TAURUS HYPOTHALAMUS 4; 1; 6; 6; 6; 3; 30; 5; 7 [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL N 20181231 61727-050_b1e5e8ac-6a7a-4290-8a1d-23bbeb61646f 61727-050 HUMAN OTC DRUG Allergy Relief Now Chemical Sensitivity Remedy Chemical Sensitivity Remedy SPRAY ORAL 20140324 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARSENIC TRIOXIDE; PHENOL; EUPHORBIA RESINIFERA RESIN; CALCIUM SULFIDE; HISTAMINE; GOLDENSEAL; STRYCHNOS IGNATII SEED; SODIUM CARBONATE; NUTMEG; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID 10; 10; 6; 10; 12; 6; 6; 10; 6; 6; 10 [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X] N 20181231 61727-051_f367d79c-2091-4191-939d-0da10e014c39 61727-051 HUMAN OTC DRUG Allergy Relief Now Food Sensitivity Remedy Food Sensitivity Remedy SPRAY ORAL 20140324 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARSENIC TRIOXIDE; KEROSENE; HYDRANGEA ARBORESCENS ROOT; SILVER NITRATE; ACTIVATED CHARCOAL; GALLIC ACID MONOHYDRATE; ACETALDEHYDE; COUMARIN; INDOLE; RUTIN; SACCHAROMYCES CEREVISIAE 6; 6; 6; 3; 12; 6; 12; 12; 12; 12; 12 [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X] N 20181231 61727-052_f2a6f972-6d51-47b0-8b11-5c72eaf04d3c 61727-052 HUMAN OTC DRUG Allergy Relief Now Inhaled Allergy Remedy Inhaled Allergy Remedy SPRAY ORAL 20140324 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ONION; AMBROSIA ARTEMISIIFOLIA; ARUNDO PLINIANA ROOT; EUPHRASIA STRICTA; HISTAMINE; NAPHTHALENE; SCHOENOCAULON OFFICINALE SEED; BLACK MUSTARD SEED; URTICA URENS; WYETHIA HELENIOIDES ROOT 5; 4; 6; 3; 12; 5; 7; 6; 6; 3 [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X] N 20181231 61727-053_8b09cba8-0e2d-4d42-a8f4-9833bf5c9433 61727-053 HUMAN OTC DRUG Allergy Relief Now Hay Fever Remedy Hay Fever Remedy SPRAY ORAL 20140325 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ONION; AMBROSIA ARTEMISIIFOLIA; ARSENIC TRIIODIDE; BROMINE; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; SANGUINARIA CANADENSIS ROOT; HISTAMINE DIHYDROCHLORIDE 6; 6; 10; 10; 6; 6; 10; 6; 6; 12 [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X] N 20181231 61727-054_28229d92-68bd-3781-e054-00144ff8d46c 61727-054 HUMAN OTC DRUG Menopause Relief Homeopathic Remedy Sepia CREAM TOPICAL 20151230 UNAPPROVED HOMEOPATHIC Homeocare Laboratories Inc. SANGUINARIA CANADENSIS ROOT; STRYCHNOS IGNATII SEED; LACHESIS MUTA WHOLE; DIOSCOREA VILLOSA ROOT; ACTAEA CIMICIFUGA ROOT; CHAMAELIRIUM LUTEUM ROOT; SEPIA ESCULENTA WHOLE; SUS SCROFA OVARY 4; 12; 12; 1; 4; 6; 12; 12 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL N 20181231 61727-101_46f3ff78-f5fd-6da1-e054-00144ff8d46c 61727-101 HUMAN OTC DRUG StellaLife VEGA Oral Care Spray SPRAY DENTAL; SUBLINGUAL 20161210 UNAPPROVED HOMEOPATHIC Homeocare Laboratories, Inc. HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; ACONITUM NAPELLUS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA; MATRICARIA RECUTITA; ECHINACEA PURPUREA; GELSEMIUM SEMPERVIRENS ROOT; MERCURY 10; 30; 3; 3; 3; 8; 12; 18; 5; 3; 30; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 61727-102_46f3ff78-f5fd-6da1-e054-00144ff8d46c 61727-102 HUMAN OTC DRUG StellaLife VEGA Oral Care Gel Gel GEL DENTAL; TOPICAL 20161210 UNAPPROVED HOMEOPATHIC Homeocare Laboratories, Inc. ACONITUM NAPELLUS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; MERCURY; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA; MATRICARIA RECUTITA; ECHINACEA PURPUREA; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE 3; 3; 3; 10; 30; 10; 12; 18; 5; 3; 30; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 61727-103_46f3ff78-f5fd-6da1-e054-00144ff8d46c 61727-103 HUMAN OTC DRUG StellaLife VEGA Oral Care Rinse Rinse RINSE DENTAL 20161210 UNAPPROVED HOMEOPATHIC Homeocare Laboratories, Inc. AZADIRACHTA INDICA BARK; CALENDULA OFFICINALIS FLOWER; ECHINACEA PURPUREA; PLANTAGO MAJOR 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 61727-105_46f3ff78-f5fd-6da1-e054-00144ff8d46c 61727-105 HUMAN OTC DRUG StellaLife VEGA Oral Care Recovery Kit KIT DENTAL; SUBLINGUAL; TOPICAL 20161210 UNAPPROVED HOMEOPATHIC Homeocare Laboratories, Inc. N 20181231 61727-111_1687a99a-44a5-4df1-8a64-dd3919c18d2d 61727-111 HUMAN OTC DRUG Arnica Relief Arnica Montana 30C TABLET ORAL 20120706 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARNICA MONTANA 30 [hp_C]/1 N 20181231 61727-112_fdffe55d-595f-4082-9047-b1adb9b82188 61727-112 HUMAN OTC DRUG Arnica Relief ARNICA MONTANA CREAM TOPICAL 20120410 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARNICA MONTANA 1 [hp_X]/56.7g N 20181231 61727-301_0c28bbde-e8f9-4de4-bdef-287567291267 61727-301 HUMAN OTC DRUG Allergy Relief ONION,APIS MELLIFERA,DROSERA ROTUNDIFOLIA,EUPHRASIA STRICTA,URTICA URENS. PELLET SUBLINGUAL 20120608 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ONION; APIS MELLIFERA; DROSERA ROTUNDIFOLIA; EUPHRASIA STRICTA; URTICA URENS 8; 8; 8; 8; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-302_46edf9c8-f4cb-4925-91e1-5278941c8dc0 61727-302 HUMAN OTC DRUG Arthritis Relief ARNICA MONTANA, BRYONIA ALBA, CHAMOMILLA,HYPERICUM PERFORATUM, KALMIA LATIFOLIA LEAF,KALMIA LATIFOLIA LEAF PELLET SUBLINGUAL 20120731 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARNICA MONTANA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; TOXICODENDRON PUBESCENS LEAF 18; 8; 8; 8; 8; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-303_6209a925-37e3-412f-8f4b-bdce4b250624 61727-303 HUMAN OTC DRUG Cold and Flu Relief ACONITUM NAPELLUS,ONION,ARNICA MONTANA,ATROPA BELLADONNA,SOLANUM DULCAMARA TOP,EUPATORIUM CANNABINUM,GELSEMIUM SEMPERVIRENS ROOT. PELLET SUBLINGUAL 20120705 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ACONITUM NAPELLUS; ONION; ARNICA MONTANA; ATROPA BELLADONNA; SOLANUM DULCAMARA TOP; EUPATORIUM CANNABINUM; GELSEMIUM SEMPERVIRENS ROOT 14; 8; 8; 8; 8; 8; 18 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-304_3b2b32d5-ed52-4b98-b508-5ddb87de0ce8 61727-304 HUMAN OTC DRUG Constipation Relief ALUMINUM OXIDE,BRYONIA ALBA ROOT,SODIUM CHLORIDE,GRAPHITE,SILICON DIOXIDE. PELLET SUBLINGUAL 20120705 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ALUMINUM OXIDE; BRYONIA ALBA ROOT; SODIUM CHLORIDE; GRAPHITE; SILICON DIOXIDE 10; 8; 8; 10; 10 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-305_45528033-480c-4dc5-8fcd-793257fd368c 61727-305 HUMAN OTC DRUG Headache Relief ATROPA BELLADONNA,CYCLAMEN PURPURASCENS TUBER,COFFEA ARABICA SEED, ROASTED,IRIS VERSICOLOR ROOT,STRYCHNOS NUX-VOMICA SEED,SANGUINARIA CANADENSIS ROOT,SPIGELIA MARILANDICA ROOT,VIBURNUM OPULUS BARK. PELLET SUBLINGUAL 20120720 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ATROPA BELLADONNA; CYCLAMEN PURPURASCENS TUBER; COFFEA ARABICA SEED, ROASTED; IRIS VERSICOLOR ROOT; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; SPIGELIA MARILANDICA ROOT; VIBURNUM OPULUS BARK 8; 8; 4; 8; 9; 8; 8; 4 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-306_350fda2c-a050-43dd-8f9d-2ab3722f1e7c 61727-306 HUMAN OTC DRUG Hemorrhoids Relief HORSE CHESTNUT,ALOE,HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,NITRIC ACID,PAEONIA OFFICINALIS ROOT,SEPIA OFFICINALIS JUICE. PELLET SUBLINGUAL 20120720 UNAPPROVED HOMEOPATHIC Homeocare Laboratories HORSE CHESTNUT; ALOE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; NITRIC ACID; PAEONIA OFFICINALIS ROOT; SEPIA OFFICINALIS JUICE 8; 8; 8; 8; 8; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-307_8379942b-ea57-463a-8f4e-79581bbde648 61727-307 HUMAN OTC DRUG Insomnia Relief Insomnia Relief PELLET SUBLINGUAL 20120720 UNAPPROVED HOMEOPATHIC Homeocare Laboratories AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; DATURA STRAMONIUM; STRYCHNOS NUX-VOMICA SEED 3; 14; 8; 8; 8; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-308_7dd4267e-8dc3-4520-9adc-e02498032b35 61727-308 HUMAN OTC DRUG Menopause Relief BARIUM CARBONATE,ATROPA BELLADONNA,BLACK COHOSH,NITROGLYCERIN,LACHESIS MUTA VENOM,SILICON DIOXIDE. PELLET SUBLINGUAL 20120723 UNAPPROVED HOMEOPATHIC Homeocare Laboratories BARIUM CARBONATE; ATROPA BELLADONNA; BLACK COHOSH; NITROGLYCERIN; LACHESIS MUTA VENOM; SILICON DIOXIDE 10; 8; 8; 8; 10; 10 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-309_a5fa8f1c-7ba8-4509-bf48-3d3c914ccb0a 61727-309 HUMAN OTC DRUG Muscular Pain Relief ARNICA MONTANA,COPPER,POTASSIUM PHOSPHATE, DIBASIC,LACTIC ACID, DL-,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE. PELLET SUBLINGUAL 20120723 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARNICA MONTANA; COPPER; POTASSIUM PHOSPHATE, DIBASIC; LACTIC ACID, DL-; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 18; 10; 8; 8; 10 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-310_585f869e-ebd3-478a-a393-98067d272167 61727-310 HUMAN OTC DRUG PMS Relief COPPER,ESTRONE,HISTAMINE DIHYDROCHLORIDE,MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE,SODIUM SULFATE. PELLET SUBLINGUAL 20120723 UNAPPROVED HOMEOPATHIC Homeocare Laboratories COPPER; ESTRONE; HISTAMINE DIHYDROCHLORIDE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; SODIUM SULFATE 10; 18; 8; 10; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-311_2807b07d-94e6-4718-9ce5-afcd4cfc3d81 61727-311 HUMAN OTC DRUG Sore Throat Relief ACONITUM NAPELLUS,APIS MELLIFERA,ATROPA BELLADONNA,SOLANUM DULCAMARA TOP,MERCURIUS SOLUBILIS,PHYTOLACCA AMERICANA ROOT. PELLET SUBLINGUAL 20120724 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; SOLANUM DULCAMARA TOP; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT 10; 10; 10; 8; 10; 8 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-312_956f35a8-4978-47ce-9790-c329fa69a90c 61727-312 HUMAN OTC DRUG Stress Relief SILVER NITRATE,MATRICARIA RECUTITA,COFFEA ARABICA SEED, ROASTED,STRYCHNOS IGNATII SEED,STRYCHNOS NUX-VOMICA SEED,PHOSPHORIC ACID,DATURA STRAMONIUM. PELLET SUBLINGUAL 20120803 UNAPPROVED HOMEOPATHIC Homeocare Laboratories SILVER NITRATE; MATRICARIA RECUTITA; COFFEA ARABICA SEED, ROASTED; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; DATURA STRAMONIUM 10; 8; 8; 10; 10; 8; 10 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-313_71116e45-db57-4870-9f33-2c50fb9ee2e5 61727-313 HUMAN OTC DRUG Vigoril for Men SILVER NITRATE,AVENA SATIVA FLOWERING TOP,TURNERA DIFFUSA LEAFY TWIG,LYCOPODIUM CLAVATUM SPORE,PHOSPHORIC ACID, SELENIUM. TABLET ORAL 20120724 UNAPPROVED HOMEOPATHIC Homeocare Laboratories SILVER NITRATE; AVENA SATIVA FLOWERING TOP; TURNERA DIFFUSA LEAFY TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SELENIUM 5; 5; 5; 5; 5; 5 [hp_C]/901; [hp_C]/901; [hp_C]/901; [hp_C]/901; [hp_C]/901; [hp_C]/901 N 20181231 61727-316_0e9bebb6-a14e-4ab4-9a40-6528e63f4e61 61727-316 HUMAN OTC DRUG Vigoril Plus SILVER NITRATE,AVENA SATIVA FLOWERING TOP,POTASSIUM PHOSPHATE, DIBASIC,STRYCHNOS NUX-VOMICA SEED,PHOSPHORIC ACID,SILICON DIOXIDE,TURNERA DIFFUSA LEAFY TWIG. PELLET SUBLINGUAL 20120814 UNAPPROVED HOMEOPATHIC Homeocare Laboratories SILVER NITRATE; AVENA SATIVA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; SILICON DIOXIDE; TURNERA DIFFUSA LEAFY TWIG 5; 9; 7; 9; 7; 5; 12 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-317_69ae4c13-0e24-4506-8484-9371dda9b515 61727-317 HUMAN OTC DRUG Vigofem Plus for Women CHASTE TREE,BARIUM CARBONATE,CONIUM MACULATUM FLOWERING TOP,PHOSPHORIC ACID,SEPIA OFFICINALIS JUICE. PELLET SUBLINGUAL 20120724 UNAPPROVED HOMEOPATHIC Homeocare Laboratories CHASTE TREE; BARIUM CARBONATE; CONIUM MACULATUM FLOWERING TOP; PHOSPHORIC ACID; SEPIA OFFICINALIS JUICE 12; 7; 4; 9; 9 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-318_201444bd-5fe2-4bea-8698-99722fc8399e 61727-318 HUMAN OTC DRUG Blatrol Bladder Relief LYTTA VESICATORIA,CAUSTICUM,EQUISETUM HYEMALE,CHONDRODENDRON TOMENTOSUM ROOT,SAW PALMETTO,SEPIA OFFICINALIS JUICE, DELPHINIUM STAPHISAGRIA SEED, PELLET SUBLINGUAL 20120618 UNAPPROVED HOMEOPATHIC Homeocare Laboratories LYTTA VESICATORIA; CAUSTICUM; EQUISETUM HYEMALE; CHONDRODENDRON TOMENTOSUM ROOT; SAW PALMETTO; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED 6; 5; 6; 5; 5; 5; 5 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-319_b859176a-c148-467e-bcb8-9fe27826bf50 61727-319 HUMAN OTC DRUG Hair-X Hair Loss Relief CADMIUM SULFATE,GRAPHITE,PHOSPHORIC ACID,SILICON DIOXIDE,SELENIUM,THALLIUM,USTILAGO MAYDIS. PELLET SUBLINGUAL 20120710 UNAPPROVED HOMEOPATHIC Homeocare Laboratories CADMIUM SULFATE; GRAPHITE; PHOSPHORIC ACID; SILICON DIOXIDE; SELENIUM; THALLIUM; USTILAGO MAYDIS 12; 4; 5; 4; 5; 7; 9 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-321_3b9f0c5f-e813-4942-ab46-9749a2b83052 61727-321 HUMAN OTC DRUG Fibromyalgia Relief ARNICA MONTANA,LACTIC ACID,STRYCHNOS NUX-VOMICA SEED,POTASSIUM PHOSPHATE, DIBASIC,CUPRIC ARSENITE. PELLET SUBLINGUAL 20120709 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARNICA MONTANA; LACTIC ACID; STRYCHNOS NUX-VOMICA SEED; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; CUPRIC ARSENITE 18; 10; 10; 10; 10; 10 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-322_b0d4be64-dbba-4778-9318-92e651e6c655 61727-322 HUMAN OTC DRUG IBS Irritable Bowel Syndrome Relief CITRULLUS COLOCYNTHIS FRUIT PULP,GRATIOLA OFFICINALIS,LYCOPODIUM CLAVATUM SPORE,SODIUM CARBONATE,STRYCHNOS NUX-VOMICA SEED,SULFUR,TAXUS BACCATA FRUIT,PODOPHYLLUM. PELLET SUBLINGUAL 20120720 UNAPPROVED HOMEOPATHIC Homeocare Laboratories CITRULLUS COLOCYNTHIS FRUIT PULP; GRATIOLA OFFICINALIS; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; SULFUR; TAXUS BACCATA FRUIT; PODOPHYLLUM 7; 5; 5; 5; 9; 5; 5; 4 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-323_cf7161f7-18e2-41ac-b86a-cb31ab0ec7b6 61727-323 HUMAN OTC DRUG Sciatica Relief ARNICA MONTANA FLOWER,BRYONIA ALBA WHOLE,MATRICARIA RECUTITA,PSEUDOGNAPHALIUM LUTEOALBUM LEAF,KALMIA LATIFOLIA LEAF,TOXICODENDRON PUBESCENS LEAF,VISCUM ALBUM LEAF. PELLET SUBLINGUAL 20120723 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARNICA MONTANA FLOWER; BRYONIA ALBA WHOLE; MATRICARIA RECUTITA; PSEUDOGNAPHALIUM LUTEOALBUM LEAF; HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM LEAF 9; 4; 200; 5; 4; 4; 4; 6 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-324_3bf28b6a-eab6-4ef1-84a9-ce36ae275dc4 61727-324 HUMAN OTC DRUG EZ-Quit ANTIMONY TRISULFIDE,DIEFFENBACHIA SEGUINE,STRYCHNOS IGNATII SEED,LOBELIA INFLATA,TOBACCO LEAF. PELLET SUBLINGUAL 20120801 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ANTIMONY TRISULFIDE; DIEFFENBACHIA SEGUINE; STRYCHNOS IGNATII SEED; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 5; 5; 5; 5; 5; 9 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-325_86ebd615-47ae-45f7-a26c-fae47d1487a7 61727-325 HUMAN OTC DRUG Ez-Slim ANTIMONY TRISULFIDE,SEMECARPUS ANACARDIUM JUICE,FUCUS VESICULOSUS,BOS TAURUS HYPOTHALAMUS,SODIUM SULFATE,PHYTOLACCA AMERICANA ROOT,THYROID, UNSPECIFIED. PELLET SUBLINGUAL 20120706 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ANTIMONY TRISULFIDE; SEMECARPUS ANACARDIUM JUICE; FUCUS VESICULOSUS; BOS TAURUS HYPOTHALAMUS; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; THYROID, UNSPECIFIED 5; 5; 1; 18; 9; 2; 8 [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-326_cdd559f3-03fa-4a74-8551-175f43b4e153 61727-326 HUMAN OTC DRUG Eczema Relief ANTIMONY TRISULFIDE,APIS MELLIFERA,ARSENIC TRIOXIDE,ATROPA BELLADONNA,GRAPHITE,ARCTIUM LAPPA FRUIT,KEROSENE,SOLIDAGO CANADENSIS WHOLE,VIOLA TRICOLOR. PELLET SUBLINGUAL 20120706 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; GRAPHITE; ARCTIUM LAPPA FRUIT; KEROSENE; SOLIDAGO CANADENSIS WHOLE; VIOLA TRICOLOR 5; 5; 5; 5; 5; 4; 5; 4; 4 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-327_ab079d8d-5b69-428c-8f24-ac286374c510 61727-327 HUMAN OTC DRUG HBP Relief BARIUM CARBONATE,ATROPA BELLADONNA,NITROGLYCERIN,LYCOPUS VIRGINICUS,STRYCHNOS NUX-VOMICA SEED,LEAD. PELLET SUBLINGUAL 20120710 UNAPPROVED HOMEOPATHIC Homeocare Laboratories BARIUM CARBONATE; ATROPA BELLADONNA; NITROGLYCERIN; LYCOPUS VIRGINICUS; STRYCHNOS NUX-VOMICA SEED; LEAD 4; 4; 4; 6; 4; 4 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-328_8ed01c5a-b6b7-4057-a04a-72378523a813 61727-328 HUMAN OTC DRUG Weight Gloss SEMECARPUS ANACARDIUM JUICE,ANTIMONY TRISULFIDE,STRYCHNOS IGNATII SEED,BOS TAURUS HYPOTHALAMUS,SULFUR,COCOA. LIPSTICK TOPICAL 20120814 UNAPPROVED HOMEOPATHIC Homeocare Laboratories SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; STRYCHNOS IGNATII SEED; BOS TAURUS HYPOTHALAMUS; SULFUR; COCOA 5; 5; 5; 5; 5; 5 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL N 20181231 61727-329_3d665f84-8d08-45c4-9845-8113c2a2121b 61727-329 HUMAN OTC DRUG Cholestop ARCTIUM LAPPA WHOLE,BERBERIS VULGARIS ROOT BARK,SILYBUM MARIANUM SEED,CHELIDONIUM MAJUS,CHOLESTEROL,CHRYSANTHELLUM INDICUM SUBSP. AFROAMERICANUM,SOLIDAGO CANADENSIS FLOWERING TOP,TARAXACUM PALUSTRE ROOT. PELLET SUBLINGUAL 20120618 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ARCTIUM LAPPA WHOLE; BERBERIS VULGARIS ROOT BARK; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CHOLESTEROL; CHRYSANTHELLUM INDICUM SUBSP. AFROAMERICANUM; SOLIDAGO CANADENSIS FLOWERING TOP; TARAXACUM PALUSTRE ROOT 4; 4; 4; 4; 9; 4; 4; 4 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-330_8fdf949d-a947-403a-9554-786f87898059 61727-330 HUMAN OTC DRUG Hangover Relief ASAFETIDA,CAPSICUM,POTASSIUM DICHROMATE,COLA NUT,LACHESIS MUTA VENOM,STRYCHNOS NUX-VOMICA SEED,RANUNCULUS BULBOSUS,SULFURIC ACID,ZINC. PELLET SUBLINGUAL 20111123 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ASAFETIDA; CAPSICUM; POTASSIUM DICHROMATE; COLA NUT; LACHESIS MUTA VENOM; STRYCHNOS NUX-VOMICA SEED; RANUNCULUS BULBOSUS; SULFURIC ACID; ZINC 5; 5; 5; 5; 5; 5; 7; 5; 5 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-332_58146f7f-009a-4109-a4be-c3d686160954 61727-332 HUMAN OTC DRUG Anxiety Relief ACONITUM NAPELLUS PELLET ORAL 20111122 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ACONITUM NAPELLUS; SILVER CATION; ARSENIC TRIOXIDE; MATRICARIA RECUTITA; COFFEE BEAN; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED 30; 12; 30; 12; 9; 9; 9 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-333_417ecbf6-fc40-4dfe-8e05-c3c72a8def31 61727-333 HUMAN OTC DRUG Carpal Tunnel Relief APIS MELLIFERA, ARNICA MONTANA,CAULOPHYLLUM ROBUSTUM ROOT,RUTA GRAVEOLENS FLOWERING TOP,VIOLA ODORATA. PELLET SUBLINGUAL 20111123 UNAPPROVED HOMEOPATHIC Homeocare Laboratories APIS MELLIFERA; ARNICA MONTANA; CAULOPHYLLUM ROBUSTUM ROOT; RUTA GRAVEOLENS FLOWERING TOP; VIOLA ODORATA 4; 4; 4; 4; 4 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-334_adb334ed-faa4-4c43-9e04-bd258d371a69 61727-334 HUMAN OTC DRUG Leg Cramps Relief CUPRIC ARSENITE,COPPER,POTASSIUM PHOSPHATE, DIBASIC,LACTIC ACID, L-,MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE. PELLET SUBLINGUAL 20111123 UNAPPROVED HOMEOPATHIC Homeocare Laboratories CUPRIC ARSENITE; COPPER; POTASSIUM PHOSPHATE, DIBASIC; LACTIC ACID, L-; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE 10; 10; 10; 10; 10 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-335_669544d9-0335-4bae-bd29-4392567f3a10 61727-335 HUMAN OTC DRUG Sinus Relief ASAFETIDA,ECHINACEA ANGUSTIFOLIA,CALCIUM SULFIDE,POTASSIUM DICHROMATE,LUFFA OPERCULATA WHOLE,SILICON DIOXIDE,SINUSITISINUM. PELLET SUBLINGUAL 20120724 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ASAFETIDA; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LUFFA OPERCULATA WHOLE; SILICON DIOXIDE; SINUSITISINUM 8; 12; 8; 18; 9; 10; 18 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_C]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-336_ed197049-a510-4a1b-b3b7-6e91cbb7644a 61727-336 HUMAN OTC DRUG Skin Klear Acne Relief TRIBASIC CALCIUM PHOSPHATE,FUMARIA OFFICINALIS FLOWERING TOP,ARCTIUM LAPPA ROOT,SODIUM CHLORIDE,SAPONARIA OFFICINALIS ROOT,SILICON DIOXIDE,SOLIDAGO VIRGAUREA FLOWERING TOP,SULFUR,VIOLA TRICOLOR. PELLET SUBLINGUAL 20120724 UNAPPROVED HOMEOPATHIC Homeocare Laboratories TRIBASIC CALCIUM PHOSPHATE; FUMARIA OFFICINALIS FLOWERING TOP; ARCTIUM LAPPA ROOT; SODIUM CHLORIDE; SAPONARIA OFFICINALIS ROOT; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; VIOLA TRICOLOR 10; 4; 4; 12; 4; 5; 3; 5; 4 [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_X]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-337_860b9ffd-ef48-4a94-999e-086c231c086d 61727-337 HUMAN OTC DRUG EZ-Quit Control ANTIMONY TRISULFIDE, DIEFFENBACHIA SEGUINE,CADMIUM SULFATE,STRYCHNOS IGNATII SEED,LOBELIA INFLATA,STRYCHNOS NUX-VOMICA SEED, TOBACCO LEAF. SPRAY SUBLINGUAL 20120709 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ANTIMONY TRISULFIDE; DIEFFENBACHIA SEGUINE; CADMIUM SULFATE; STRYCHNOS IGNATII SEED; LOBELIA INFLATA; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF 5; 5; 5; 5; 5; 5; 8 [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL; [hp_C]/15mL N 20181231 61727-338_4c7af6f2-d53c-4d20-a5b2-818331e2b442 61727-338 HUMAN OTC DRUG EZ-Detox Super Drainage Formula AESCULUS HIPPOCASTANUM BARK,ANTIMONY TRISULFIDE,SILVER NITRATE,ARNICA MONTANA,BERBERIS VULGARIS WHOLE,ACTIVATED CHARCOAL,CEANOTHUS AMERICANUS WHOLE,CHOLESTEROL,CINCHONA BARK,CYNARA SCOLYMUS LEAF,EQUISETUM ARVENSE TOP,CONYZA CANADENSIS,FUCUS VESICULOSUS,GINKGO,HAMAMELIS VIRGINIANA LEAF,CHAMAELIRIUM LUTEUM ROOT,GOLDENSEAL,ARCTIUM LAPPA ROOT,LESPEDEZA CAPITATA FLOWERING TOP,RANUNCULUS BULBOSUS,DAIKON,ROBINIA PSEUDOACACIA BARK,TARAXACUM PALUSTRE ROOT,VIBURNUM PRUNIFOLIUM BARK,VITIS VINIFERA WHOLE. LIQUID ORAL 20120709 UNAPPROVED HOMEOPATHIC Homeocare Laboratories AESCULUS HIPPOCASTANUM BARK; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; BERBERIS VULGARIS WHOLE; ACTIVATED CHARCOAL; CEANOTHUS AMERICANUS WHOLE; CHOLESTEROL; CINCHONA BARK; CYNARA SCOLYMUS LEAF; EQUISETUM ARVENSE TOP; CONYZA CANADENSIS; FUCUS VESICULOSUS; GINKGO; HAMAMELIS VIRGINIANA LEAF; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; ARCTIUM LAPPA ROOT; LESPEDEZA CAPITATA FLOWERING TOP; RANUNCULUS BULBOSUS; DAIKON; ROBINIA PSEUDOACACIA BARK; TARAXACUM PALUSTRE ROOT; VIBURNUM PRUNIFOLIUM BARK; VITIS VINIFERA WHOLE 6; 10; 10; 6; 6; 9; 6; 10; 8; 6; 6; 6; 6; 10; 6; 6; 6; 6; 6; 4; 6; 10; 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 61727-339_8d8c4f3c-405b-425d-ae95-55988b172b6f 61727-339 HUMAN OTC DRUG Acute Asthma Relief ACONITUM NAPELLUS,ARSENIC TRIOXIDE,BLATTA ORIENTALIS,SOLANUM DULCAMARA TOP,IPECAC,NAPHTHALENE,QUEBRACHO BARK, PHOSPHORUS,HISTAMINE DIHYDROCHLORIDE PELLET SUBLINGUAL 20120516 UNAPPROVED HOMEOPATHIC Homeocare Laboratories ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BLATTA ORIENTALIS; SOLANUM DULCAMARA TOP; IPECAC; NAPHTHALENE; QUEBRACHO BARK; PHOSPHORUS; HISTAMINE DIHYDROCHLORIDE 10; 10; 7; 10; 6; 10; 3; 8; 7 [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g; [hp_X]/4g N 20181231 61727-340_4083ce3d-9d29-4df8-aae0-3a164cd60f6c 61727-340 HUMAN OTC DRUG Memo-Rx HORSE CHESTNUT,ALUMINUM OXIDE,SEMECARPUS ANACARDIUM JUICE,BARIUM CARBONATE,BOS TAURUS CEREBELLUM,GINKGO,POTASSIUM PHOSPHATE, DIBASIC. PELLET SUBLINGUAL 20120720 UNAPPROVED HOMEOPATHIC Homeocare Laboratories HORSE CHESTNUT; ALUMINUM OXIDE; SEMECARPUS ANACARDIUM JUICE; BARIUM CARBONATE; BOS TAURUS CEREBELLUM; GINKGO; POTASSIUM PHOSPHATE, DIBASIC 5; 5; 5; 5; 5; 5; 5 [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g; [hp_C]/4g N 20181231 61727-341_f8e4f799-6574-40fc-b496-d4b08b792410 61727-341 HUMAN OTC DRUG Influenzinum Influenzinum 9C PELLET SUBLINGUAL 20121031 UNAPPROVED HOMEOPATHIC Homeocare Laboratories INFLUENZA A VIRUS; INFLUENZA B VIRUS 9; 9 [hp_C]/4g; [hp_C]/4g N 20181231 61727-342_e2e36af1-4d99-45ee-84a1-546346b34b19 61727-342 HUMAN OTC DRUG Relaxagen SILVER NITRATE,ACONITUM NAPELLUS,GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS IGNATII SEED,POTASSIUM PHOSPHATE, DIBASIC,SILICON DIOXIDE LIQUID ORAL 20120914 UNAPPROVED HOMEOPATHIC Homeocare Laboratories SILVER NITRATE; ACONITUM NAPELLUS; ACONITUM NAPELLUS; ACONITUM NAPELLUS; SILVER NITRATE; SILVER NITRATE; SILVER NITRATE; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; SILICON DIOXIDE 10; 9; 15; 30; 9; 15; 30; 9; 9; 8; 8 [hp_X]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 61727-345_20fecb11-d3a5-6f1d-e054-00144ff88e88 61727-345 HUMAN OTC DRUG ANACOCCINUM CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE PELLET SUBLINGUAL 20150930 UNAPPROVED HOMEOPATHIC HomeoCare Laboratories CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/1 N 20181231 61727-400_508572b9-041b-4cfa-9c6d-8ae3b973a6e4 61727-400 HUMAN OTC DRUG Neti Mist Sinus Spray POTASSIUM CHLORIDE LIQUID NASAL 20111114 UNAPPROVED HOMEOPATHIC Homeocare Laboratories POTASSIUM CHLORIDE 6 [hp_X]/29.5mL N 20181231 61727-401_d2fd40e2-492a-40d4-a464-2f530fa6a14a 61727-401 HUMAN OTC DRUG Neti Wash Flu HAEMOPHILUS INFLUENZAE TYPE B LIQUID ORAL 20120105 UNAPPROVED HOMEOPATHIC Homeocare Laboratories HAEMOPHILUS INFLUENZAE TYPE B 9 [hp_C]/29.5mL N 20181231 61734-010_5d059977-374c-931b-e053-2a91aa0a0943 61734-010 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20141008 OTC MONOGRAPH NOT FINAL part356 Delon Laboratories (1990) Ltd HYDROGEN PEROXIDE 3 mL/100mL N 20181231 61734-012_5d167b1f-e65f-353b-e053-2991aa0a3d1d 61734-012 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 Isopropyl Alcohol SOLUTION TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part333A Delon Laboratories (1990) Ltd. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 61734-021_5d52d155-fe6d-22d2-e053-2991aa0a0a84 61734-021 HUMAN OTC DRUG Blue Ice Analgesic Menthol GEL TOPICAL 20100507 OTC MONOGRAPH NOT FINAL part348 Delon Laboratories (1990) Ltd MENTHOL 2 g/100g N 20181231 61734-030_5d54ba53-4215-2ed6-e053-2991aa0adaed 61734-030 HUMAN OTC DRUG Vaporizing Colds Rub Menthol OINTMENT TOPICAL 20110524 OTC MONOGRAPH FINAL part341 Delon Laboratories (1990) Ltd MENTHOL; EUCALYPTUS OIL; CAMPHOR (SYNTHETIC) 2.6; 1.2; 4.73 g/100g; g/100g; g/100g N 20181231 61734-040_5962fe6b-0109-6bb7-e053-2991aa0a82f4 61734-040 HUMAN OTC DRUG Petroleum Petrolatum JELLY TOPICAL 20171002 OTC MONOGRAPH FINAL part347 Delon Laboratories (1990) Ltd PETROLATUM 100 g/100g N 20181231 61734-040_5d8e9d28-3732-242e-e053-2a91aa0a895f 61734-040 HUMAN OTC DRUG Petroleum Petrolatum JELLY TOPICAL 20100507 OTC MONOGRAPH FINAL part347 Delon Laboratories (1990) Ltd PETROLATUM 100 g/100g N 20181231 61734-050_405385f8-cf59-4a2f-e054-00144ff8d46c 61734-050 HUMAN OTC DRUG Babyfresh Petroleum Jelly Petrolatum JELLY TOPICAL 20100507 OTC MONOGRAPH FINAL part347 Delon Laboratories (1990) Ltd PETROLATUM 99.7 g/100g N 20181231 61734-300_5d527b9e-1ede-897a-e053-2a91aa0ae92a 61734-300 HUMAN OTC DRUG La Vaquita New Regular Methyl Salicylate OINTMENT TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part348 Delon Laboratories (1990) Ltd MENTHOL; METHYL SALICYLATE 2; 10 g/100g; g/100g N 20181231 61734-301_5d52181a-8c7a-225f-e053-2991aa0af9e0 61734-301 HUMAN OTC DRUG La Vaquita New Extra Methyl Salicylate, Menthol OINTMENT TOPICAL 20110426 OTC MONOGRAPH NOT FINAL part348 Delon Laboratories (1990) Ltd METHYL SALICYLATE; MENTHOL 12; 3 g/100g; g/100g N 20181231 61744-050_d6658aeb-7bc1-4eef-ad0d-0a873ddbecf5 61744-050 HUMAN PRESCRIPTION DRUG IMPAVIDO miltefosine CAPSULE ORAL 20140919 NDA NDA204684 Paladin Therapeutics Inc. MILTEFOSINE 50 mg/1 Antileishmanial [EPC] E 20171231 61748-011_2a4439c0-251c-4264-9af9-687ab2536d9c 61748-011 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20150318 ANDA ANDA075095 VersaPharm Incorporated ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] N 20181231 61748-012_ecee3128-a47f-4ced-a1db-4f58c5f3e9c6 61748-012 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 19950401 ANDA ANDA081319 VersaPharm Incorporated PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] N 20181231 61748-013_1247f0c8-25be-49b0-96e1-22b1cf50dc00 61748-013 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19970901 ANDA ANDA087425 VersaPharm Incorporated ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 61748-014_2a4439c0-251c-4264-9af9-687ab2536d9c 61748-014 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20150318 ANDA ANDA075095 VersaPharm Incorporated ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] N 20181231 61748-015_9dbaffcd-4e71-4ea0-9adb-634a2af7b857 61748-015 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20010701 ANDA ANDA065028 VersaPharm Incorporated RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 61748-016_1247f0c8-25be-49b0-96e1-22b1cf50dc00 61748-016 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19970901 ANDA ANDA080212 VersaPharm Incorporated ISONIAZID 100 mg/1 Antimycobacterial [EPC] N 20181231 61748-017_1d3f27ec-1616-40fd-bc4f-91bb1744ceb0 61748-017 HUMAN PRESCRIPTION DRUG IsonaRif Rifampin and Isoniazid CAPSULE ORAL 20050901 ANDA ANDA065221 VersaPharm Incorporated RIFAMPIN; ISONIAZID 300; 150 mg/1; mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient],Antimycobacterial [EPC] N 20181231 61748-018_9dbaffcd-4e71-4ea0-9adb-634a2af7b857 61748-018 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20010701 ANDA ANDA065028 VersaPharm Incorporated RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 61748-024_aa34937d-3a90-4659-b6b4-dd1412db2225 61748-024 HUMAN PRESCRIPTION DRUG Ethosuximide Ethosuximide SOLUTION ORAL 20040101 ANDA ANDA040506 VersaPharm Incorporated ETHOSUXIMIDE 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61748-025_ea863fbc-c47d-4130-a9b7-10b53f1db0e5 61748-025 HUMAN PRESCRIPTION DRUG Ethosuximide Ethosuximide CAPSULE ORAL 20080901 ANDA ANDA040686 VersaPharm Incorporated ETHOSUXIMIDE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61748-044_49a23821-76f9-45a4-a79b-aff14769bad1 61748-044 HUMAN PRESCRIPTION DRUG Aminocaproic Acid Aminocaproic Acid SYRUP ORAL 20000301 ANDA ANDA074759 VersaPharm Incorporated AMINOCAPROIC ACID .25 g/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 61748-045_49a23821-76f9-45a4-a79b-aff14769bad1 61748-045 HUMAN PRESCRIPTION DRUG Aminocaproic Acid Aminocaproic Acid TABLET ORAL 20010801 ANDA ANDA075602 VersaPharm Incorporated AMINOCAPROIC ACID 500 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 61748-046_49a23821-76f9-45a4-a79b-aff14769bad1 61748-046 HUMAN PRESCRIPTION DRUG Aminocaproic Acid Aminocaproic Acid TABLET ORAL 20120601 NDA AUTHORIZED GENERIC NDA015197 VersaPharm Incorporated AMINOCAPROIC ACID 1000 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 61748-054_17402030-cc8f-40ba-ac8a-865fce102c03 61748-054 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride SYRUP ORAL 20010301 ANDA ANDA040251 VersaPharm Incorporated TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/5mL N 20181231 61748-111_bd7113f1-cbc8-43f9-9cb1-e6bb9b5588bd 61748-111 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19980401 ANDA ANDA062396 VersaPharm Incorporated DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 61748-113_95e1d2b0-56ab-4628-a762-d086f52fd127 61748-113 HUMAN PRESCRIPTION DRUG demeclocycline hydrochloride demeclocycline hydrochloride TABLET, FILM COATED ORAL 20081215 ANDA ANDA065389 VersaPharm Incorporated DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 61748-115_95e1d2b0-56ab-4628-a762-d086f52fd127 61748-115 HUMAN PRESCRIPTION DRUG demeclocycline hydrochloride demeclocycline hydrochloride TABLET, FILM COATED ORAL 20081215 ANDA ANDA065389 VersaPharm Incorporated DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 61748-200_2bc21396-13d3-4e4a-8260-153f4e2c15f2 61748-200 HUMAN PRESCRIPTION DRUG CICLOPIROX CICLOPIROX SOLUTION TOPICAL 20100320 ANDA ANDA078975 VersaPharm Incorporated CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] E 20171231 61748-201_46b9e41c-7dd9-46bf-9e1e-4a34e55b4ae9 61748-201 HUMAN PRESCRIPTION DRUG Clindamycin phosphate Clindamycin phosphate SOLUTION TOPICAL 20100710 ANDA ANDA065513 VersaPharm Incorporated CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 61748-202_f01651d8-68ae-4513-8df8-0cb77475aa9b 61748-202 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin SOLUTION TOPICAL 20100801 ANDA ANDA090215 VersaPharm Incorporated ERYTHROMYCIN 20 mg/mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 61748-205_c501cef7-dcfe-43b3-82d5-c15c94562fab 61748-205 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone GEL TOPICAL 20110411 ANDA ANDA090727 VersaPharm Incorporated DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61748-206_29000d5b-a9db-4303-9823-360349e52ebe 61748-206 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20140912 ANDA ANDA201005 VersaPharm Incorporated DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61748-207_4241d01a-8144-4e73-8cac-a5052f85be39 61748-207 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 20170119 ANDA ANDA203787 VersaPharm Incorporated DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61748-208_acae1b2b-038f-4058-ac4e-91d5660af844 61748-208 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 20150630 ANDA ANDA203234 VersaPharm Incorporated DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61748-210_93064340-3648-427a-a7f3-18e5737dd748 61748-210 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE DENTAL 20160819 ANDA ANDA206312 VersaPharm Incorporated TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61748-218_6f42a6b3-e7a6-43c5-9c30-2a4ed442a9b2 61748-218 HUMAN PRESCRIPTION DRUG TRIAMCINOLONE ACETONIDE triamcinolone acetonide AEROSOL, SPRAY TOPICAL 20170501 ANDA ANDA207094 VersaPharm, Inc. - An Akorn Company TRIAMCINOLONE ACETONIDE .147 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61748-219_7d397347-421d-45cd-bdf3-26bfad2597b3 61748-219 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide LOTION TOPICAL 20130521 ANDA ANDA202374 VersaPharm Incorporated TRIAMCINOLONE ACETONIDE .25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61748-220_7d397347-421d-45cd-bdf3-26bfad2597b3 61748-220 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide LOTION TOPICAL 20130521 ANDA ANDA202374 VersaPharm Incorporated TRIAMCINOLONE ACETONIDE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61748-250_073e8bfa-b95c-46e9-83a5-9cf1a6884514 61748-250 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL AURICULAR (OTIC) 20160913 ANDA ANDA202705 VersaPharm Incorporated FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61748-301_8a1a1438-cbda-4fa4-b74a-eb3caeacbd3f 61748-301 HUMAN PRESCRIPTION DRUG Myorisan isotretinoin CAPSULE, LIQUID FILLED ORAL 20120501 ANDA ANDA076485 VersaPharm Incorporated ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 61748-302_8a1a1438-cbda-4fa4-b74a-eb3caeacbd3f 61748-302 HUMAN PRESCRIPTION DRUG Myorisan isotretinoin CAPSULE, LIQUID FILLED ORAL 20120501 ANDA ANDA076485 VersaPharm Incorporated ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 61748-303_8a1a1438-cbda-4fa4-b74a-eb3caeacbd3f 61748-303 HUMAN PRESCRIPTION DRUG Myorisan isotretinoin CAPSULE, LIQUID FILLED ORAL 20150826 ANDA ANDA076485 VersaPharm Incorporated ISOTRETINOIN 30 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 61748-304_8a1a1438-cbda-4fa4-b74a-eb3caeacbd3f 61748-304 HUMAN PRESCRIPTION DRUG Myorisan isotretinoin CAPSULE, LIQUID FILLED ORAL 20120501 ANDA ANDA076485 VersaPharm Incorporated ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 61748-350_8e3f2bd9-09ca-44f1-ab5a-6dcec8bcc9a9 61748-350 HUMAN PRESCRIPTION DRUG Diflorasone Diacetate Diflorasone Diacetate OINTMENT TOPICAL 20160308 ANDA ANDA206572 VersaPharm Incorporated DIFLORASONE DIACETATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61748-365_9c6fb8f7-c357-4b06-a271-d87f0f334230 61748-365 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20160907 ANDA ANDA207049 VersaPharm Incorporated VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 61748-366_9c6fb8f7-c357-4b06-a271-d87f0f334230 61748-366 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20160907 ANDA ANDA207049 VersaPharm Incorporated VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 61748-380_5e1c2386-e75a-41e2-9aa7-6fc8462f6d5b 61748-380 HUMAN PRESCRIPTION DRUG CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SPRAY TOPICAL 20170612 ANDA ANDA207218 VersaPharm, Inc. - An Akorn Company CLOBETASOL PROPIONATE .05 g/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61748-400_ece04acb-bc22-46e4-8a97-e098bccca8e6 61748-400 HUMAN PRESCRIPTION DRUG Lindane Lindane SHAMPOO TOPICAL 20111121 ANDA ANDA087266 VersaPharm Incorporated LINDANE 10 mg/mL E 20171231 61748-401_ae63df5b-5334-4e9a-a255-d9ea1144b0ce 61748-401 HUMAN PRESCRIPTION DRUG Lindane Lindane LOTION TOPICAL 20111205 ANDA ANDA087313 VersaPharm Incorporated LINDANE 10 mg/mL E 20171231 61748-425_181627ba-eb38-4d9d-9268-38ca1306914d 61748-425 HUMAN PRESCRIPTION DRUG NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin and triamcinolone acetonide OINTMENT TOPICAL 20170901 ANDA ANDA207217 VersaPharm, Inc. - An Akorn Company NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61748-470_6ff66e7e-68a6-4bbd-85a6-e0f4d4a963d5 61748-470 HUMAN PRESCRIPTION DRUG Desonide Desonide OINTMENT TOPICAL 20170901 ANDA ANDA208836 VersaPharm, Inc. - An Akorn Company DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61750-0022_5d6d4948-d0d1-896b-e053-2991aa0a91f7 61750-0022 HUMAN OTC DRUG Immuno Compound Homeopathic Tonic alfalfa, avena sativa flowering top, oyster shell calcium carbonate, crude, goldenseal, salix nigra bark LIQUID ORAL 20110214 UNAPPROVED HOMEOPATHIC HRC Laboratories, Inc. ALFALFA; AVENA SATIVA FLOWERING TOP; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GOLDENSEAL; SALIX NIGRA BARK 1; 1; 1; 1; 1 [hp_X]/236.6mL; [hp_X]/236.6mL; [hp_X]/236.6mL; [hp_X]/236.6mL; [hp_X]/236.6mL N 20181231 61755-001_affea015-5d74-46f4-b85e-d647d08268c0 61755-001 HUMAN PRESCRIPTION DRUG Arcalyst rilonacept INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20080227 BLA BLA125249 Regeneron Pharmaceuticals, Inc. RILONACEPT 160 mg/2mL N 20181231 61755-005_e24a1294-2b12-4bc6-b527-51e355e9d692 61755-005 HUMAN PRESCRIPTION DRUG EYLEA aflibercept INJECTION, SOLUTION INTRAVITREAL 20111121 BLA BLA125387 Regeneron Pharmaceuticals, Inc. AFLIBERCEPT 40 mg/mL Vascular Endothelial Growth Factor Inhibitor [EPC],Vascular Endothelial Growth Factor Inhibitors [MoA] N 20181231 61767-001_8f1f9218-cdf8-4217-af36-2269f532b7fe 61767-001 HUMAN OTC DRUG Mineral Oil MINERAL OIL ENEMA RECTAL 20140201 OTC MONOGRAPH NOT FINAL part334 Blossom Pharmaceuticals MINERAL OIL 118 mL/118mL N 20181231 61767-002_4e78a959-948f-4b34-bd90-21ced9cb128a 61767-002 HUMAN OTC DRUG Saline enema SALINE ENEMA ENEMA RECTAL 20140201 OTC MONOGRAPH NOT FINAL part334 Blossom Pharmaceuticals SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL N 20181231 61767-219_e231c3af-75a8-42db-8a8c-743d92ec25d5 61767-219 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20140306 OTC MONOGRAPH FINAL part333B Blossom Pharmaceuticals BACITRACIN 500 [iU]/g N 20181231 61767-220_0b739768-64f5-4905-89aa-bb043169d94b 61767-220 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20140514 OTC MONOGRAPH FINAL part333B Blossom Pharmaceuticals BACITRACIN ZINC 500 [USP'U]/g N 20181231 61767-222_0aeacffd-4c75-4018-bbd6-f734980cb2b5 61767-222 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20140514 OTC MONOGRAPH FINAL part347 Blossom Pharmaceuticals ZINC OXIDE 200 mg/g N 20181231 61767-224_49f52e32-fdeb-43c5-a341-008d64a43514 61767-224 HUMAN OTC DRUG Hydrocortisone Hydrocortisone Acetate CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part348 Blossom Pharmaceuticals HYDROCORTISONE ACETATE 1 g/100g N 20181231 61767-226_72edacb1-503c-4254-8b5b-e477ea55c617 61767-226 HUMAN OTC DRUG Dyna1195 zinc oxide OINTMENT TOPICAL 20141023 OTC MONOGRAPH FINAL part347 Blossom Pharmaceuticals ZINC OXIDE 1.8 g/100g N 20181231 61767-228_3cfaedb1-70c1-43ee-baf5-5ff1b3454443 61767-228 HUMAN OTC DRUG Dyna1199 with Dimethicone zinc oxide OINTMENT TOPICAL 20141023 OTC MONOGRAPH FINAL part347 Blossom Pharmaceuticals ZINC OXIDE; DIMETHICONE 2; 1.8 g/100g; g/100g N 20181231 61767-231_0be9814f-595e-47da-ae39-4def3d8ab994 61767-231 HUMAN OTC DRUG Blossom Pharmaceuticals Antifungal antifungal CREAM TOPICAL 20140509 OTC MONOGRAPH FINAL part333C Blossom Pharmaceticals CLOTRIMAZOLE 1 g/100g N 20181231 61767-232_06eade62-c684-485c-bedc-ca7eef96f73c 61767-232 HUMAN OTC DRUG Lana1263 Lanolin OINTMENT TOPICAL 20141023 OTC MONOGRAPH FINAL part347 Blossom Pharmaceuticals LANOLIN 50 g/100g N 20181231 61767-234_c19d6a7b-7523-47e9-aa39-7ac9ea666e81 61767-234 HUMAN OTC DRUG Menthol and Zinc Oxide Menthol and Zinc Oxide OINTMENT TOPICAL 20141011 OTC MONOGRAPH FINAL part347 Blossom Pharmaceuticals MENTHOL; ZINC OXIDE .44; 21 g/100g; g/100g N 20181231 61767-304_6d01ed55-94e7-4d5f-831d-ea330fce8199 61767-304 HUMAN OTC DRUG Alcohol Isopropyl Alcohol LIQUID TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Blossom Pharmaceuticals ISOPROPYL ALCOHOL .7 mL/mL N 20181231 61767-305_41fb98df-814c-4a1a-a83e-cfcfa0bfdf2f 61767-305 HUMAN OTC DRUG Alcohol Isopropyl Alcohol LIQUID TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Blossom Pharmaceuticals ISOPROPYL ALCOHOL .99 mL/mL N 20181231 61767-306_606ce526-8f1e-4534-8e98-6858b0bd552b 61767-306 HUMAN OTC DRUG Blossom HP 3 Hydrogen peroxide LIQUID TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part356 Blossom Pharmaceuticals HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 61767-406_7e55067e-7226-4055-b7fd-0399ede09bda 61767-406 HUMAN OTC DRUG Muscle rub Menthol, Camphor, Methyl Salicylate CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part348 Blossom Pharmaceuticals MENTHOL; CAMPHOR (NATURAL); METHYL SALICYLATE 100; 40; 300 mg/g; mg/g; mg/g N 20181231 61776-0001_5fefe56d-1ff6-9e7c-e053-2991aa0a42b5 61776-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19870101 UNAPPROVED MEDICAL GAS CMS Imaging Inc dba Medco OXYGEN 99 L/100L N 20181231 61786-001_4e917110-db62-4ad8-bb2f-5f40ef1c5150 61786-001 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20141218 ANDA ANDA077893 REMEDYREPACK INC. POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 61786-001_9a3ae131-88a9-41af-a681-d8ba04289f52 61786-001 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20140805 ANDA ANDA077893 REMEDYREPACK INC. POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 61786-002_3d9951c7-110c-5706-e054-00144ff8d46c 61786-002 HUMAN OTC DRUG ACETA-GESIC ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20140808 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 325; 12.5 mg/1; mg/1 E 20171231 61786-004_57727985-da1b-64b8-e053-2a91aa0a3411 61786-004 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140812 ANDA ANDA076133 REMEDYREPACK INC. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-005_57732e1d-bf13-9e59-e053-2a91aa0a99b0 61786-005 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140812 ANDA ANDA076133 REMEDYREPACK INC. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-008_47561719-ed65-141f-e054-00144ff8d46c 61786-008 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20140815 ANDA ANDA090168 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 61786-009_577389a7-9419-8a6e-e053-2991aa0a6db6 61786-009 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140821 ANDA ANDA201507 REMEDYREPACK INC. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 61786-010_577348fc-cf02-bb0e-e053-2991aa0a5bf1 61786-010 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20140827 ANDA ANDA090170 REMEDYREPACK INC. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 61786-012_57750474-6e4f-e654-e053-2991aa0af7d9 61786-012 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20141009 ANDA ANDA040765 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 61786-016_478c38b5-64fd-5fba-e054-00144ff88e88 61786-016 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20140826 ANDA ANDA091240 REMEDYREPACK INC. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-018_57761635-8e7b-ffaf-e053-2a91aa0a8f48 61786-018 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20140903 ANDA ANDA090168 REMEDYREPACK INC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 61786-019_577685a8-4fa1-3f29-e053-2a91aa0a9a1c 61786-019 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140902 ANDA ANDA202419 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 61786-020_4767acb1-a3cb-2fb2-e054-00144ff88e88 61786-020 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20140903 ANDA ANDA074132 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 61786-021_6301aa49-baf3-2724-e053-2991aa0a0eb8 61786-021 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140902 ANDA ANDA075932 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 61786-022_5777da7f-9749-3a3a-e053-2a91aa0a4264 61786-022 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140909 ANDA ANDA201507 REMEDYREPACK INC. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 61786-025_3b055a35-7156-6977-e054-00144ff88e88 61786-025 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 20140910 ANDA ANDA085692 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61786-026_5c518111-bcd4-1c1f-e053-2a91aa0a9d4c 61786-026 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20140911 NDA NDA021234 REMEDYREPACK INC. DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-027_5c5423be-0845-74ec-e053-2a91aa0abc87 61786-027 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE 20140911 NDA NDA011757 REMEDYREPACK INC. METHYLPREDNISOLONE ACETATE 80 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61786-032_4769b879-0b7c-704c-e054-00144ff88e88 61786-032 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20140916 ANDA ANDA040901 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 61786-040_4c84dcb5-08f5-0cad-e054-00144ff88e88 61786-040 HUMAN PRESCRIPTION DRUG Rectacort - HC HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20170406 UNAPPROVED DRUG OTHER REMEDYREPACK INC. HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61786-044_479016ff-11ab-46b4-e054-00144ff8d46c 61786-044 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20140925 ANDA ANDA090528 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 61786-051_578b019f-ef77-c1d5-e053-2a91aa0a9d07 61786-051 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20141007 ANDA ANDA201109 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-052_44e61de9-8b8d-4d14-8b36-9d4418e2c69f 61786-052 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20141008 ANDA ANDA077380 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 61786-058_57e8513e-63e3-0e31-e053-2991aa0a4754 61786-058 HUMAN PRESCRIPTION DRUG VIGAMOX moxifloxacin hydrochloride SOLUTION/ DROPS OPHTHALMIC 20170829 NDA NDA021598 REMEDYREPACK INC. MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 61786-064_5799aca9-3955-d405-e053-2991aa0aab8d 61786-064 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20141013 ANDA ANDA201109 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-068_47f4f989-fae0-6576-e054-00144ff8d46c 61786-068 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20141023 ANDA ANDA079067 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 61786-069_5799d952-d476-0b08-e053-2a91aa0afe8b 61786-069 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141022 ANDA ANDA202419 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 61786-072_3aa901c1-35c4-29ea-e054-00144ff8d46c 61786-072 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20141028 ANDA ANDA077562 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] E 20171231 61786-074_5799d952-d4c5-0b08-e053-2a91aa0afe8b 61786-074 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20141022 ANDA ANDA088467 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 61786-077_4809cf08-d230-5b42-e054-00144ff8d46c 61786-077 HUMAN PRESCRIPTION DRUG Vasotec Enalapril Maleate TABLET ORAL 20141024 NDA NDA018998 REMEDYREPACK INC. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 61786-082_579a5b93-a8b7-2821-e053-2991aa0ac705 61786-082 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20141028 ANDA ANDA074802 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 61786-083_3a58676a-05c1-00d9-e054-00144ff8d46c 61786-083 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20141031 ANDA ANDA077562 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 61786-086_61d2b6c6-838d-afd6-e053-2991aa0aa1fb 61786-086 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20141106 ANDA ANDA076143 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 61786-089_61d2a923-ff61-6a92-e053-2a91aa0aaf19 61786-089 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20141112 ANDA ANDA076143 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 61786-091_e524319f-5c0b-457c-be35-0e7b3918c036 61786-091 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 20150402 ANDA ANDA072641 REMEDYREPACK INC. CLOTRIMAZOLE 1 g/100g E 20171231 61786-107_4952a90a-eef0-30ab-e054-00144ff8d46c 61786-107 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20141202 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-109_49535360-f06e-4db0-e054-00144ff8d46c 61786-109 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20141203 ANDA ANDA077241 REMEDYREPACK INC. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 61786-112_37fe86b6-e058-4ad4-e054-00144ff88e88 61786-112 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20141204 ANDA ANDA065271 REMEDYREPACK INC. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61786-115_4a1ae84f-cf78-2f91-e054-00144ff8d46c 61786-115 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20141210 ANDA ANDA071251 REMEDYREPACK INC. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 61786-117_4a2b2e55-3f25-1b90-e054-00144ff8d46c 61786-117 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20141210 ANDA ANDA078888 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 61786-122_05ff1989-bb39-466a-b39f-97970f5360cf 61786-122 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20141216 ANDA ANDA065215 REMEDYREPACK INC. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61786-125_579c589f-ffab-97c8-e053-2991aa0a1490 61786-125 HUMAN PRESCRIPTION DRUG Depakote Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141216 NDA NDA018723 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 61786-126_4a2c78c4-3058-2421-e054-00144ff88e88 61786-126 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20141218 ANDA ANDA040901 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 61786-128_4a2d354d-f9b1-7083-e054-00144ff8d46c 61786-128 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20141229 ANDA ANDA202389 REMEDYREPACK INC. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-137_4a2f362d-1434-6572-e054-00144ff8d46c 61786-137 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20150109 ANDA ANDA065093 REMEDYREPACK INC. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 61786-141_85be9dea-d0e7-4408-8df0-613eb87b0fe8 61786-141 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20150124 ANDA ANDA065215 REMEDYREPACK INC. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61786-142_47e610f5-ab07-3c7d-e054-00144ff8d46c 61786-142 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20150112 ANDA ANDA087385 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61786-149_579cf875-56d8-7917-e053-2991aa0a4eba 61786-149 HUMAN OTC DRUG Rugby Travel Sickness Meclizine HCl, 25 mg Each (Antiemetic) Meclizine HCl TABLET, CHEWABLE ORAL 20150116 OTC MONOGRAPH FINAL part336 REMEDYREPACK INC. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 61786-150_dde8c098-db4c-4741-a540-50f5e429e013 61786-150 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20150124 ANDA ANDA065291 REMEDYREPACK INC. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61786-151_f89147a2-0919-46ba-b9d5-81fc1f921970 61786-151 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20150124 ANDA ANDA065215 REMEDYREPACK INC. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61786-154_4a53a156-9b55-5403-e054-00144ff8d46c 61786-154 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium and Prednisolone Sodium Phosphate Sulfacetamide Sodium and Prednisolone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 20150120 ANDA ANDA074449 REMEDYREPACK INC. SULFACETAMIDE SODIUM; PREDNISOLONE SODIUM PHOSPHATE 100; 2.3 mg/mL; mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61786-155_5f8ad9e0-de39-1c24-e053-2a91aa0ad070 61786-155 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20150123 ANDA ANDA075798 REMEDYREPACK INC. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 61786-158_4aa2c5b9-96c5-5e8d-e054-00144ff8d46c 61786-158 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20150121 ANDA ANDA091305 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-161_3d58c96e-f007-67bc-e054-00144ff8d46c 61786-161 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20150126 ANDA ANDA078220 REMEDYREPACK INC. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 61786-167_323154da-a0d1-1c94-e054-00144ff8d46c 61786-167 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160506 ANDA ANDA075350 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-173_4a6927be-d1fe-3e3d-e054-00144ff8d46c 61786-173 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20150202 ANDA ANDA202389 REMEDYREPACK INC. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-175_579dcbdd-d61d-12fc-e053-2a91aa0aa278 61786-175 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20150217 ANDA ANDA079163 REMEDYREPACK INC. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 61786-176_579e5c99-73d6-89f7-e053-2991aa0a8dec 61786-176 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20150227 ANDA ANDA065150 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 61786-179_579dcbdd-d665-12fc-e053-2a91aa0aa278 61786-179 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20150224 ANDA ANDA077666 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 N 20181231 61786-182_579dcbdd-d6ca-12fc-e053-2a91aa0aa278 61786-182 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20150210 ANDA ANDA088629 REMEDYREPACK INC. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 61786-186_4aa335d1-1ed2-72c8-e054-00144ff8d46c 61786-186 HUMAN PRESCRIPTION DRUG ZOVIRAX acyclovir CAPSULE ORAL 20150213 NDA NDA018828 REMEDYREPACK INC. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 61786-188_588c7a44-a364-676a-e053-2a91aa0a57b3 61786-188 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20150213 ANDA ANDA090749 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-192_4aa58e72-d0c9-09fb-e054-00144ff8d46c 61786-192 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20150226 ANDA ANDA090515 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-200_57d6c15a-dc7b-83dd-e053-2991aa0a573e 61786-200 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20150224 ANDA ANDA077056 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 61786-201_57d70eef-94ed-70e1-e053-2a91aa0a52a1 61786-201 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20150305 ANDA ANDA087479 REMEDYREPACK INC. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 61786-204_57d744cf-17f1-36e4-e053-2991aa0a8145 61786-204 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20150309 ANDA ANDA202446 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 61786-206_57d704f7-f1c1-88f8-e053-2a91aa0a3d07 61786-206 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20150312 ANDA ANDA201003 REMEDYREPACK INC. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-208_4accf4c2-2dff-6c48-e054-00144ff8d46c 61786-208 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20150304 ANDA ANDA077666 REMEDYREPACK INC. MIRTAZAPINE 45 mg/1 N 20181231 61786-217_06365ac7-9146-4114-96e3-e11eeb4d49de 61786-217 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride IRRIGANT IRRIGATION 20150311 NDA NDA016733 REMEDYREPACK INC. SODIUM CHLORIDE .9 g/100mL E 20171231 61786-220_57d97101-adb8-50b7-e053-2991aa0a8a79 61786-220 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20150312 ANDA ANDA090170 REMEDYREPACK INC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 61786-221_57d9ec20-1bfe-204f-e053-2991aa0afaed 61786-221 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20150310 ANDA ANDA090960 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-230_4af5593d-3252-2e2a-e054-00144ff88e88 61786-230 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20150317 ANDA ANDA090121 REMEDYREPACK INC. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 61786-232_57da6a2c-8606-604e-e053-2991aa0ab7e5 61786-232 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20150326 ANDA ANDA201003 REMEDYREPACK INC. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-233_37619ca0-0738-0c76-e054-00144ff88e88 61786-233 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20150317 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 61786-235_57dad7f7-9f62-ca16-e053-2991aa0a8cf0 61786-235 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20150318 ANDA ANDA077794 REMEDYREPACK INC. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-236_57dae7c8-cc30-1c65-e053-2991aa0ac58a 61786-236 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20150326 ANDA ANDA202446 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 61786-237_4af51867-572e-10cb-e054-00144ff8d46c 61786-237 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20150323 ANDA ANDA075511 REMEDYREPACK INC. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 61786-240_39bdbfe3-731b-34aa-e054-00144ff88e88 61786-240 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20150323 ANDA ANDA075743 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61786-244_57db85ca-f2ad-62dc-e053-2a91aa0aa476 61786-244 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150403 ANDA ANDA200834 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-245_4b319ab9-ee0d-56cf-e054-00144ff8d46c 61786-245 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20150406 ANDA ANDA090937 REMEDYREPACK INC. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 61786-246_57ea4bd2-d46f-4394-e053-2991aa0a2bb4 61786-246 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20150406 ANDA ANDA201003 REMEDYREPACK INC. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-247_57ea7f8a-26a6-367e-e053-2a91aa0a93e1 61786-247 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20150401 ANDA ANDA201384 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 61786-252_3cf39b86-6ccf-55a1-e054-00144ff8d46c 61786-252 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20150407 ANDA ANDA077253 REMEDYREPACK INC. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 61786-256_57eaa9af-f340-098f-e053-2a91aa0a8760 61786-256 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20150414 ANDA ANDA201003 REMEDYREPACK INC. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-257_471c8f96-4b47-6e8e-e054-00144ff8d46c 61786-257 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20150414 ANDA ANDA076161 REMEDYREPACK INC. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 61786-258_57eab132-7793-4282-e053-2a91aa0a2327 61786-258 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20150414 ANDA ANDA201003 REMEDYREPACK INC. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-263_4b47659f-7de6-2c20-e054-00144ff8d46c 61786-263 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20150417 ANDA ANDA065062 REMEDYREPACK INC. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 61786-265_39a74050-ad67-5f77-e054-00144ff8d46c 61786-265 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20150416 ANDA ANDA065225 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 61786-266_4b5acd9a-9bf3-0b1a-e054-00144ff88e88 61786-266 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20150417 ANDA ANDA090510 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 61786-268_4b5b4487-2566-1a97-e054-00144ff8d46c 61786-268 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20150422 ANDA ANDA202446 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 61786-269_5d065491-325c-66c4-e053-2a91aa0a0767 61786-269 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20150422 ANDA ANDA202556 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 61786-277_4d4bd591-e8df-4f31-91be-41ca72a79319 61786-277 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20150522 ANDA ANDA062713 REMEDYREPACK INC. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61786-280_4b7065ad-cbff-1700-e054-00144ff88e88 61786-280 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20150429 ANDA ANDA200292 REMEDYREPACK INC. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 61786-282_381719ea-b276-2898-e054-00144ff8d46c 61786-282 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 20150429 NDA NDA018810 REMEDYREPACK INC. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 61786-283_4b8001ba-ad3e-291d-e054-00144ff8d46c 61786-283 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20150429 ANDA ANDA076635 REMEDYREPACK INC. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 61786-284_4b80acd4-cf41-49b0-e054-00144ff8d46c 61786-284 HUMAN PRESCRIPTION DRUG clotrimazole and betamethasone dipropionate clotrimazole and betamethasone dipropionate CREAM TOPICAL 20150429 ANDA ANDA076002 REMEDYREPACK INC. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61786-285_60a31cd8-a3c1-5af4-e053-2a91aa0af27c 61786-285 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20171218 ANDA ANDA075693 REMEDYREPACK INC. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 61786-289_57ec9858-1e15-5055-e053-2a91aa0a603f 61786-289 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20150505 ANDA ANDA078902 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-290_4bdf7769-4a25-4f5d-e054-00144ff8d46c 61786-290 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150430 ANDA ANDA078946 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 61786-293_57ed9eaa-8f48-07bd-e053-2a91aa0ab855 61786-293 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20150504 ANDA ANDA078235 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 61786-294_57ec9858-1ec0-5055-e053-2a91aa0a603f 61786-294 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20150916 ANDA ANDA076255 REMEDYREPACK INC. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-295_4be31c8e-81c3-11d2-e054-00144ff8d46c 61786-295 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20150504 NDA NDA006488 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 61786-298_57ec9858-1f1d-5055-e053-2a91aa0a603f 61786-298 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20150508 ANDA ANDA090278 REMEDYREPACK INC. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 61786-304_5a46243e-cfcd-9a5c-e053-2a91aa0ab365 61786-304 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170928 ANDA ANDA088629 REMEDYREPACK INC. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 61786-309_5e9987ea-1cc6-ca26-e053-2a91aa0adde9 61786-309 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20150512 ANDA ANDA075315 REMEDYREPACK INC. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 61786-310_3ac4bdbe-e96a-3f8b-e054-00144ff88e88 61786-310 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20150512 ANDA ANDA077657 REMEDYREPACK INC. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61786-316_57eaae0d-3cf1-405c-e053-2a91aa0aa4e5 61786-316 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 20150519 NDA NDA018140 REMEDYREPACK INC. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61786-319_57ed9eaa-8f4c-07bd-e053-2a91aa0ab855 61786-319 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150601 ANDA ANDA200834 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-322_4bd26448-07b9-3bb2-e054-00144ff88e88 61786-322 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20150529 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-324_57ee19e6-2f86-ad06-e053-2a91aa0acc0c 61786-324 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20150604 ANDA ANDA202446 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 61786-326_57eff3fc-1f49-7108-e053-2a91aa0a79bb 61786-326 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20150604 ANDA ANDA078181 REMEDYREPACK INC. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 61786-331_4beabee3-9eb3-10e6-e054-00144ff8d46c 61786-331 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20150610 ANDA ANDA090858 REMEDYREPACK INC. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-332_4bea46c7-0560-5709-e054-00144ff88e88 61786-332 HUMAN OTC DRUG DOK DOCUSATE SODIUM CAPSULE ORAL 20150618 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. DOCUSATE SODIUM 100 mg/1 N 20181231 61786-334_58025b51-d2f8-6238-e053-2a91aa0ae0a6 61786-334 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150615 ANDA ANDA201519 REMEDYREPACK INC. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-335_4beb14eb-13b4-301b-e054-00144ff8d46c 61786-335 HUMAN OTC DRUG Adult Low Dose Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20150611 OTC MONOGRAPH FINAL part343 REMEDYREPACK INC. ASPIRIN 81 mg/1 N 20181231 61786-336_624f2db1-b840-6536-e053-2991aa0adb49 61786-336 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20150615 ANDA ANDA076118 REMEDYREPACK INC. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 61786-341_a6890a31-4f7d-48a3-85cc-bdc46aed74ed 61786-341 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20150616 ANDA ANDA077259 REMEDYREPACK INC. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61786-343_4bfbcc7e-6986-3556-e054-00144ff88e88 61786-343 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20150615 ANDA ANDA076118 REMEDYREPACK INC. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 61786-345_4bfb8d15-7729-2877-e054-00144ff88e88 61786-345 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20150615 ANDA ANDA074185 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 61786-346_4bfcf805-c0f5-29b4-e054-00144ff8d46c 61786-346 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20150618 ANDA ANDA070175 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61786-350_4bfe6a02-3409-62dc-e054-00144ff8d46c 61786-350 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20150619 ANDA ANDA090515 REMEDYREPACK INC. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-351_4bfea41a-0354-2248-e054-00144ff88e88 61786-351 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20150619 NDA NDA018851 REMEDYREPACK INC. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-354_4c0d490d-4227-6547-e054-00144ff8d46c 61786-354 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20150624 ANDA ANDA076957 REMEDYREPACK INC. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 61786-358_3348624b-8200-1dd4-e054-00144ff8d46c 61786-358 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20150623 ANDA ANDA071404 REMEDYREPACK INC. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61786-361_58147576-23a1-2bd1-e053-2991aa0a7657 61786-361 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20150708 ANDA ANDA078993 REMEDYREPACK INC. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-363_58147576-23df-2bd1-e053-2991aa0a7657 61786-363 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20150709 ANDA ANDA090460 REMEDYREPACK INC. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 61786-365_379a3fd9-b400-4abd-e054-00144ff8d46c 61786-365 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 20150720 ANDA ANDA089175 REMEDYREPACK INC. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 61786-366_5814dd36-bfa5-6c42-e053-2a91aa0a2936 61786-366 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20150715 ANDA ANDA201109 REMEDYREPACK INC. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-367_5815043a-bb99-c9f7-e053-2991aa0a17fa 61786-367 HUMAN PRESCRIPTION DRUG Quetiapine quetiapine TABLET ORAL 20150715 ANDA ANDA201109 REMEDYREPACK INC. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-372_581655f5-233d-31de-e053-2a91aa0ae0e2 61786-372 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20150717 ANDA ANDA040803 REMEDYREPACK INC. DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61786-375_4cffa957-f48e-0b05-e054-00144ff8d46c 61786-375 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET, FILM COATED ORAL 20150828 ANDA ANDA077045 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-377_58181113-5452-36f0-e053-2a91aa0a550d 61786-377 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20150721 ANDA ANDA071307 REMEDYREPACK INC. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61786-378_4d01ad91-f757-7059-e054-00144ff88e88 61786-378 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20150721 ANDA ANDA075743 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61786-380_58183c39-ba21-5efd-e053-2a91aa0a4b96 61786-380 HUMAN PRESCRIPTION DRUG bupropion bupropion TABLET, EXTENDED RELEASE ORAL 20150728 ANDA ANDA201567 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 61786-384_4d16bc8e-ef9f-5e4f-e054-00144ff8d46c 61786-384 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20150727 ANDA ANDA203834 REMEDYREPACK INC. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 61786-386_58253067-9707-74d3-e053-2a91aa0adbec 61786-386 HUMAN PRESCRIPTION DRUG Norvir Ritonavir TABLET, FILM COATED ORAL 20170901 NDA NDA022417 REMEDYREPACK INC. RITONAVIR 100 mg/1 UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 61786-387_4d26ea53-cfd6-4f9b-e054-00144ff88e88 61786-387 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20150731 ANDA ANDA078895 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 61786-388_4d5d67c7-b458-42ac-e054-00144ff88e88 61786-388 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20160113 ANDA ANDA071669 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 61786-389_518f9c70-7f42-5ebd-e054-00144ff88e88 61786-389 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20150805 ANDA ANDA090931 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 61786-394_4cfd32f1-4567-7285-e054-00144ff8d46c 61786-394 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20150818 ANDA ANDA077234 REMEDYREPACK INC. AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 61786-396_4cead341-e53b-5cf9-e054-00144ff8d46c 61786-396 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20150831 ANDA ANDA078895 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 61786-397_4ce98aba-d12b-6ae3-e054-00144ff8d46c 61786-397 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20150831 ANDA ANDA090960 REMEDYREPACK INC. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-398_2f497d59-ab85-09f1-e054-00144ff8d46c 61786-398 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160330 ANDA ANDA065329 REMEDYREPACK INC. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61786-399_4ce89cb6-5dcd-14df-e054-00144ff88e88 61786-399 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20150902 ANDA ANDA076533 REMEDYREPACK INC. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 61786-403_4ce8bf61-e908-1ebc-e054-00144ff88e88 61786-403 HUMAN OTC DRUG Sore Throat Cherry Phenol LIQUID ORAL 20150904 OTC MONOGRAPH NOT FINAL part356 REMEDYREPACK INC. PHENOL 1.5 g/100mL N 20181231 61786-404_481d8fca-b705-2009-e054-00144ff8d46c 61786-404 HUMAN PRESCRIPTION DRUG Diclofenac Potassium diclofenac potassium TABLET, FILM COATED ORAL 20150904 ANDA ANDA075463 REMEDYREPACK INC. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-406_4ce57287-1837-4b5b-e054-00144ff8d46c 61786-406 HUMAN OTC DRUG Milk of Magnesia Milk of Magnesia CONCENTRATE ORAL 20150904 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. MAGNESIUM HYDROXIDE 2400 mg/10mL N 20181231 61786-411_22cef84c-f13a-4c32-af8b-e7239a81a3c6 61786-411 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20150917 ANDA ANDA076658 REMEDYREPACK INC. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 61786-412_4cd64ebd-01af-2804-e054-00144ff88e88 61786-412 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20150914 ANDA ANDA085182 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 61786-413_4cd4c898-fef0-721f-e054-00144ff88e88 61786-413 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20150917 ANDA ANDA076697 REMEDYREPACK INC. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 61786-415_4cd25677-9d7a-0bf2-e054-00144ff8d46c 61786-415 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20150915 ANDA ANDA062713 REMEDYREPACK INC. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61786-416_5270deb2-52a9-2d21-e054-00144ff88e88 61786-416 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20150918 ANDA ANDA040226 REMEDYREPACK INC. PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 61786-419_58276ff1-d60b-746e-e053-2991aa0a2044 61786-419 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20150926 ANDA ANDA078627 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-422_58291d8c-9831-69d2-e053-2a91aa0ad971 61786-422 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20150930 ANDA ANDA040226 REMEDYREPACK INC. PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 61786-425_58291d8c-984e-69d2-e053-2a91aa0ad971 61786-425 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20150930 ANDA ANDA078627 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-426_58291d8c-986d-69d2-e053-2a91aa0ad971 61786-426 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20151006 ANDA ANDA078627 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-428_4c97a021-fb60-13e3-e054-00144ff88e88 61786-428 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20151002 ANDA ANDA071403 REMEDYREPACK INC. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61786-429_4c9909f7-7ce7-2679-e054-00144ff8d46c 61786-429 HUMAN PRESCRIPTION DRUG Cefoxitin CEFOXITIN INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20151006 ANDA ANDA065313 REMEDYREPACK INC. CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61786-430_58291d8c-988c-69d2-e053-2a91aa0ad971 61786-430 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20151117 ANDA ANDA078993 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-436_582a63c3-7de6-05d1-e053-2a91aa0a6f5f 61786-436 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151013 ANDA ANDA078583 REMEDYREPACK INC. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-437_4c845cc8-bab0-019d-e054-00144ff88e88 61786-437 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20151013 ANDA ANDA040226 REMEDYREPACK INC. PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 61786-439_490e6b83-15c9-6829-e054-00144ff88e88 61786-439 HUMAN OTC DRUG Imodium A-D Loperamide hydrochloride TABLET, FILM COATED ORAL 20170221 ANDA ANDA075232 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 61786-440_4c838582-8f7b-4c3f-e054-00144ff8d46c 61786-440 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20151013 ANDA ANDA079139 REMEDYREPACK INC. LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] N 20181231 61786-442_4c82e066-5561-4852-e054-00144ff88e88 61786-442 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20151013 ANDA ANDA202285 REMEDYREPACK INC. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-443_4c70fabb-b8a9-5f9e-e054-00144ff88e88 61786-443 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20151013 ANDA ANDA091038 REMEDYREPACK INC. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-444_582a63c3-7e3c-05d1-e053-2a91aa0a6f5f 61786-444 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20151016 ANDA ANDA078627 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-445_582c1833-612a-915e-e053-2a91aa0a0ccf 61786-445 HUMAN PRESCRIPTION DRUG Tegretol carbamazepine TABLET ORAL 20151019 NDA NDA016608 REMEDYREPACK INC. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 61786-446_4c725fd5-3bb6-6db5-e054-00144ff8d46c 61786-446 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20151016 ANDA ANDA086183 REMEDYREPACK INC. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 61786-447_3ab1157c-6bca-0bb2-e054-00144ff88e88 61786-447 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20151019 ANDA ANDA075113 REMEDYREPACK INC. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61786-448_582c3bdf-63fb-bfd9-e053-2a91aa0afa1f 61786-448 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20151019 NDA NDA021515 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 61786-449_587825d5-625f-ac2c-e053-2991aa0a9e7a 61786-449 HUMAN PRESCRIPTION DRUG WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20151019 NDA NDA021515 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 61786-450_587b109d-6cc2-1d72-e053-2991aa0a7332 61786-450 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20151019 ANDA ANDA078154 REMEDYREPACK INC. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-451_4c94975a-f337-413f-e054-00144ff8d46c 61786-451 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20151016 ANDA ANDA062936 REMEDYREPACK INC. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 61786-452_4c4856b1-862c-452e-e054-00144ff88e88 61786-452 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate INJECTION, SOLUTION INTRAVENOUS 20151019 NDA NDA203629 REMEDYREPACK INC. NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 61786-453_587b109d-6d05-1d72-e053-2991aa0a7332 61786-453 HUMAN OTC DRUG pseudoephedrine hydrochloride Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151019 ANDA ANDA075153 REMEDYREPACK INC. PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 61786-454_4c46f57f-3758-1b53-e054-00144ff88e88 61786-454 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20151021 ANDA ANDA201109 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-456_587c66a7-d539-a19b-e053-2a91aa0aef57 61786-456 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20151027 ANDA ANDA078627 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-462_3b533ffb-66bc-5fd5-e054-00144ff88e88 61786-462 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20151106 ANDA ANDA072192 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 61786-464_4c0d5849-9502-1958-e054-00144ff88e88 61786-464 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20151102 ANDA ANDA075522 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 61786-465_587cad33-1212-0039-e053-2a91aa0a524b 61786-465 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20151103 ANDA ANDA202824 REMEDYREPACK INC. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 61786-469_3e2a7e28-e12b-1082-e054-00144ff8d46c 61786-469 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160125 ANDA ANDA075350 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61786-470_4c5c937f-ff79-19ea-e054-00144ff88e88 61786-470 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151102 NDA AUTHORIZED GENERIC NDA020198 REMEDYREPACK INC. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 61786-471_505f17a2-a4b8-3d8c-e054-00144ff88e88 61786-471 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20151105 ANDA ANDA088487 REMEDYREPACK INC. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 61786-473_587cdf7a-c262-3257-e053-2a91aa0a9358 61786-473 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin CREAM TOPICAL 20151109 ANDA ANDA201587 REMEDYREPACK INC. MUPIROCIN CALCIUM 2 g/100g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 61786-474_4bcdf254-f067-29b7-e054-00144ff88e88 61786-474 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20151105 ANDA ANDA078895 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 61786-475_4188e081-a06e-16f9-e054-00144ff8d46c 61786-475 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 20161117 OTC MONOGRAPH NOT FINAL part343 REMEDYREPACK INC. ACETAMINOPHEN 500 mg/1 E 20171231 61786-476_4bceb540-59d5-0167-e054-00144ff8d46c 61786-476 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20151109 ANDA ANDA062703 REMEDYREPACK INC. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61786-480_4bcd575f-d77d-10d8-e054-00144ff88e88 61786-480 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20151109 ANDA ANDA062936 REMEDYREPACK INC. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 61786-481_588cf86f-3301-d121-e053-2991aa0a0644 61786-481 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20151111 ANDA ANDA078154 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-482_588d3ea9-28ef-b6b9-e053-2991aa0a86f2 61786-482 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20151119 NDA NDA019668 REMEDYREPACK INC. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 61786-484_588d9ffa-7ebb-2d9b-e053-2991aa0ac702 61786-484 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20151118 ANDA ANDA076133 REMEDYREPACK INC. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-485_588dde40-f746-0480-e053-2a91aa0ae055 61786-485 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 20170320 ANDA ANDA074746 REMEDYREPACK INC. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61786-486_4bba1af6-da1b-58ae-e054-00144ff8d46c 61786-486 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20151120 ANDA ANDA090798 REMEDYREPACK INC. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-487_588da56e-feb2-fde6-e053-2a91aa0a6339 61786-487 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE Tramadol hydrochloride TABLET ORAL 20151124 ANDA ANDA091498 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 61786-488_588dde40-f76f-0480-e053-2a91aa0ae055 61786-488 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20151123 ANDA ANDA202824 REMEDYREPACK INC. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 61786-490_49b22812-7733-435a-e054-00144ff88e88 61786-490 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20151125 ANDA ANDA078895 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 61786-493_4b7f4054-1d56-05f7-e054-00144ff8d46c 61786-493 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20151127 ANDA ANDA075868 REMEDYREPACK INC. FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 61786-496_58909bc9-787c-62de-e053-2a91aa0a0447 61786-496 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151203 ANDA ANDA078583 REMEDYREPACK INC. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-498_63047273-2cd7-244a-e053-2991aa0a6e3d 61786-498 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151210 ANDA ANDA090325 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 61786-499_5333689f-fe43-0387-e054-00144ff88e88 61786-499 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20160104 ANDA ANDA076939 REMEDYREPACK INC. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61786-502_4b7c6d1c-1e18-59ac-e054-00144ff8d46c 61786-502 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20151211 ANDA ANDA077419 REMEDYREPACK INC. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 61786-504_4b7bed39-7aa7-07ae-e054-00144ff88e88 61786-504 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20151216 ANDA ANDA078251 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 61786-505_589f7ad8-9e6a-5855-e053-2a91aa0afd4f 61786-505 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20151216 ANDA ANDA076286 REMEDYREPACK INC. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 61786-507_589fb578-569c-660d-e053-2a91aa0aead1 61786-507 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151215 ANDA ANDA077442 REMEDYREPACK INC. PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 61786-509_4b7aa3f3-567b-5491-e054-00144ff88e88 61786-509 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20151221 ANDA ANDA202556 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 61786-512_4b6b2447-01f1-378d-e054-00144ff8d46c 61786-512 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20151223 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. DOCUSATE SODIUM 100 mg/1 N 20181231 61786-513_4b69dc93-8255-5802-e054-00144ff88e88 61786-513 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20151224 ANDA ANDA077042 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-514_58a00a6e-1466-220e-e053-2991aa0ab401 61786-514 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20151224 ANDA ANDA090749 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-515_4b67b6e8-7859-073b-e054-00144ff8d46c 61786-515 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20151224 NDA AUTHORIZED GENERIC NDA021323 REMEDYREPACK INC. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-516_5d8644d6-2fb7-2f72-e053-2a91aa0a6422 61786-516 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20151229 ANDA ANDA090200 REMEDYREPACK INC. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 61786-519_58a04a57-5553-20ab-e053-2991aa0a91bd 61786-519 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20151224 ANDA ANDA076000 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-522_4b663e5a-a442-269a-e054-00144ff8d46c 61786-522 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20151224 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-523_4b571a79-4b0e-1327-e054-00144ff88e88 61786-523 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20151224 ANDA ANDA078525 REMEDYREPACK INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 61786-524_58a08d44-6e37-6adc-e053-2991aa0a3a51 61786-524 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20151224 ANDA ANDA090120 REMEDYREPACK INC. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-526_58a0dc4c-4c59-bc47-e053-2991aa0a2273 61786-526 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20151224 ANDA ANDA079088 REMEDYREPACK INC. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-527_4b565c73-a4b8-44eb-e054-00144ff8d46c 61786-527 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE, LIQUID FILLED ORAL 20151224 ANDA ANDA073484 REMEDYREPACK INC. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 61786-528_58a09a06-e919-d04d-e053-2a91aa0aea7d 61786-528 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20151224 ANDA ANDA076000 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-529_58a0dc4c-4cb2-bc47-e053-2991aa0a2273 61786-529 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20151224 ANDA ANDA079088 REMEDYREPACK INC. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-530_58a0dc4c-4d08-bc47-e053-2991aa0a2273 61786-530 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20151224 ANDA ANDA076000 REMEDYREPACK INC. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-531_58a178b5-1acc-326a-e053-2991aa0ae789 61786-531 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20151224 ANDA ANDA090858 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-532_2823e6d3-2c53-6694-e054-00144ff88e88 61786-532 HUMAN OTC DRUG Adult Low Dose Enteric Coated Aspirin Aspirin TABLET, COATED ORAL 20151230 OTC MONOGRAPH FINAL part343 REMEDYREPACK INC. ASPIRIN 81 mg/1 E 20171231 61786-534_58a33c01-7584-1f9d-e053-2a91aa0a667c 61786-534 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160215 ANDA ANDA077285 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 61786-537_58a4a8c3-f79e-5401-e053-2991aa0a032e 61786-537 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20160106 ANDA ANDA091672 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 61786-538_513fbd6a-5c26-5566-e054-00144ff88e88 61786-538 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20160109 ANDA ANDA040362 REMEDYREPACK INC. PREDNISONE 10 mg/1 N 20181231 61786-539_58b36f80-3eb4-69a8-e053-2a91aa0aa8e4 61786-539 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20160114 ANDA ANDA076255 REMEDYREPACK INC. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-540_3816c2fe-0b5f-5f1c-e054-00144ff88e88 61786-540 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20160112 ANDA ANDA072193 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 61786-541_58b369ac-689e-5701-e053-2991aa0a1ae6 61786-541 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20160114 ANDA ANDA078993 REMEDYREPACK INC. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-546_58b40918-df5f-26ec-e053-2a91aa0aa7d2 61786-546 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160114 ANDA ANDA200834 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-547_58b5c690-b58e-4cad-e053-2a91aa0ad416 61786-547 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20160122 ANDA ANDA078993 REMEDYREPACK INC. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-549_3aaf58c6-c5fb-03fa-e054-00144ff8d46c 61786-549 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20160121 ANDA ANDA078889 REMEDYREPACK INC. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61786-550_4b3def87-a63e-41fc-e054-00144ff8d46c 61786-550 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20160121 ANDA ANDA076658 REMEDYREPACK INC. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 61786-551_58b63f70-9c8b-9f79-e053-2a91aa0a328c 61786-551 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 20160125 ANDA ANDA074673 REMEDYREPACK INC. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 61786-552_4b2e6322-af80-0daf-e054-00144ff88e88 61786-552 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20160122 ANDA ANDA202389 REMEDYREPACK INC. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-553_58b63f70-9caf-9f79-e053-2a91aa0a328c 61786-553 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20160115 ANDA ANDA040616 REMEDYREPACK INC. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 61786-555_58f3f57a-81f6-2b67-e053-2991aa0adcd1 61786-555 HUMAN PRESCRIPTION DRUG DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20160117 ANDA ANDA074943 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 61786-558_58f3f57a-8228-2b67-e053-2991aa0adcd1 61786-558 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20160127 ANDA ANDA203277 REMEDYREPACK INC. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61786-561_49c08daf-d32b-2c5b-e054-00144ff8d46c 61786-561 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20160128 ANDA ANDA072575 REMEDYREPACK INC. PRAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 61786-564_49b31ba6-b290-6b2d-e054-00144ff8d46c 61786-564 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20160125 ANDA ANDA200044 REMEDYREPACK INC. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 61786-565_3a76631c-8ff3-4413-e054-00144ff88e88 61786-565 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20160126 ANDA ANDA200044 REMEDYREPACK INC. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 61786-566_49b1ed19-c8e8-2f4f-e054-00144ff8d46c 61786-566 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20160126 ANDA ANDA078554 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-567_49b1b006-b7fe-354e-e054-00144ff88e88 61786-567 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20160126 ANDA ANDA077932 REMEDYREPACK INC. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-568_49b12d66-2665-263d-e054-00144ff88e88 61786-568 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20160129 ANDA ANDA090778 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-569_58f3f57a-8254-2b67-e053-2991aa0adcd1 61786-569 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20160203 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 61786-570_58f3f57a-82b3-2b67-e053-2991aa0adcd1 61786-570 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20160201 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 61786-571_58f3f57a-8312-2b67-e053-2991aa0adcd1 61786-571 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20160203 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 61786-576_3aeaff1b-86a7-5a09-e054-00144ff8d46c 61786-576 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20160203 ANDA ANDA079067 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 61786-577_49ae89d7-484b-5432-e054-00144ff8d46c 61786-577 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20160208 ANDA ANDA077147 REMEDYREPACK INC. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61786-579_3d59c4b6-b13d-1c18-e054-00144ff88e88 61786-579 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20160208 ANDA ANDA076796 REMEDYREPACK INC. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 61786-580_58f3f57a-8371-2b67-e053-2991aa0adcd1 61786-580 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20160210 ANDA ANDA090278 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 61786-581_58f3f57a-83b3-2b67-e053-2991aa0adcd1 61786-581 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20160210 ANDA ANDA090455 REMEDYREPACK INC. ERGOCALCIFEROL 1.25 1/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 61786-585_58f3f57a-83c9-2b67-e053-2991aa0adcd1 61786-585 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20160212 ANDA ANDA077561 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-586_58f55587-e7e3-8f7e-e053-2991aa0a63bd 61786-586 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20160212 ANDA ANDA077561 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-589_4ade1569-9f54-6e73-e054-00144ff8d46c 61786-589 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20160210 ANDA ANDA078216 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-592_499b068e-edda-0cbb-e054-00144ff8d46c 61786-592 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20160212 ANDA ANDA090843 REMEDYREPACK INC. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-593_58f5f0fa-680e-b83d-e053-2a91aa0ab23c 61786-593 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20160218 ANDA ANDA040301 REMEDYREPACK INC. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 61786-594_58f60cd7-145b-11eb-e053-2991aa0aad44 61786-594 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20160215 ANDA ANDA076410 REMEDYREPACK INC. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 61786-595_58f62ccb-e27a-2b84-e053-2991aa0afe89 61786-595 HUMAN OTC DRUG FLONASEALLERGY RELIEF ALLERGY RELIEF fluticasone propionate SPRAY, METERED NASAL 20160215 NDA NDA205434 REMEDYREPACK INC. FLUTICASONE PROPIONATE 50 ug/1 N 20181231 61786-598_499a7164-777d-582b-e054-00144ff8d46c 61786-598 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20160223 ANDA ANDA078115 REMEDYREPACK INC. CARBAMAZEPINE 400 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 61786-600_49999606-dcd9-6674-e054-00144ff88e88 61786-600 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20160223 ANDA ANDA040796 REMEDYREPACK INC. FOLIC ACID 1 mg/1 N 20181231 61786-602_4adce832-2417-5790-e054-00144ff88e88 61786-602 HUMAN PRESCRIPTION DRUG Labetalol HCL Labetalol Hydrochloride TABLET, FILM COATED ORAL 20160223 ANDA ANDA200908 REMEDYREPACK INC. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61786-603_49993057-c0f0-27f8-e054-00144ff8d46c 61786-603 HUMAN PRESCRIPTION DRUG PEXEVA paroxetine mesylate TABLET, FILM COATED ORAL 20160223 NDA NDA021299 REMEDYREPACK INC. PAROXETINE MESYLATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-605_49987ed1-55ce-444f-e054-00144ff88e88 61786-605 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20160224 ANDA ANDA076745 REMEDYREPACK INC. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 61786-606_5904c18b-b6a4-662f-e053-2991aa0a9049 61786-606 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20160229 ANDA ANDA077561 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-608_5904c18b-b6f8-662f-e053-2991aa0a9049 61786-608 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20160229 ANDA ANDA090843 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-610_5904f126-e834-a892-e053-2991aa0aef0f 61786-610 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20160304 ANDA ANDA077561 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-611_59054614-1ab5-f51a-e053-2991aa0a2301 61786-611 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20160303 ANDA ANDA090278 REMEDYREPACK INC. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 61786-612_590560e1-8efb-2fd3-e053-2991aa0a39c3 61786-612 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20160303 ANDA ANDA090843 REMEDYREPACK INC. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-614_3774d33a-b501-4255-e054-00144ff88e88 61786-614 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20160308 ANDA ANDA077783 REMEDYREPACK INC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 61786-616_49369038-18cd-0860-e054-00144ff8d46c 61786-616 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20160307 ANDA ANDA078203 REMEDYREPACK INC. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 61786-617_4adb61b3-049e-5810-e054-00144ff8d46c 61786-617 HUMAN PRESCRIPTION DRUG Diazepam DIAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160307 ANDA ANDA072079 REMEDYREPACK INC. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61786-620_49350893-2987-2e61-e054-00144ff8d46c 61786-620 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20160311 ANDA ANDA090702 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 61786-621_6316188c-fdd8-2059-e053-2a91aa0a3189 61786-621 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20160314 ANDA ANDA074505 REMEDYREPACK INC. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 61786-622_4933f751-2d91-6aa5-e054-00144ff8d46c 61786-622 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20160315 ANDA ANDA086925 REMEDYREPACK INC. ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 61786-623_590668e3-e025-10d1-e053-2991aa0aff74 61786-623 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20160316 ANDA ANDA090278 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 61786-624_3da680bb-e52a-2238-e054-00144ff8d46c 61786-624 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20160316 ANDA ANDA077783 REMEDYREPACK INC. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 61786-625_3ab0c48b-b5f1-56b5-e054-00144ff8d46c 61786-625 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20160316 ANDA ANDA077783 REMEDYREPACK INC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 61786-626_5d80e97e-ff04-c396-e053-2a91aa0a923e 61786-626 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20160314 ANDA ANDA040616 REMEDYREPACK INC. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 61786-629_492163a4-997a-1c6d-e054-00144ff8d46c 61786-629 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20160315 ANDA ANDA202556 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 61786-631_49b0ece6-5876-7133-e054-00144ff8d46c 61786-631 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20160322 ANDA ANDA200981 REMEDYREPACK INC. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61786-632_402d7401-1af5-7446-e054-00144ff8d46c 61786-632 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20160324 ANDA ANDA091305 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61786-634_402cc5fd-398d-3a8e-e054-00144ff8d46c 61786-634 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20160324 ANDA ANDA091305 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61786-639_4ad94400-5f14-6e34-e054-00144ff8d46c 61786-639 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20160325 ANDA ANDA077438 REMEDYREPACK INC. LEVOFLOXACIN 750 mg/1 N 20181231 61786-640_490f544d-78b9-0b6e-e054-00144ff88e88 61786-640 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20160325 ANDA ANDA072234 REMEDYREPACK INC. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 61786-641_490da075-2caa-5006-e054-00144ff88e88 61786-641 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20160330 ANDA ANDA078103 REMEDYREPACK INC. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61786-645_3fa2c0ea-1afc-08ac-e054-00144ff8d46c 61786-645 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20160405 ANDA ANDA204314 REMEDYREPACK INC. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 61786-649_48fe18a8-d611-6f0f-e054-00144ff8d46c 61786-649 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20160406 ANDA ANDA078020 REMEDYREPACK INC. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 61786-653_48fc42e2-f756-66c6-e054-00144ff88e88 61786-653 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20160408 ANDA ANDA076509 REMEDYREPACK INC. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 61786-658_4aa30323-7ead-698e-e054-00144ff8d46c 61786-658 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20160411 ANDA ANDA078895 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 61786-667_4aa2327a-f219-441e-e054-00144ff8d46c 61786-667 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20160420 ANDA ANDA201190 REMEDYREPACK INC. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-668_59084933-4002-57a8-e053-2991aa0a8616 61786-668 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20160420 ANDA ANDA090278 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 61786-672_48beed49-5c5d-0723-e054-00144ff88e88 61786-672 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 20160425 ANDA ANDA088004 REMEDYREPACK INC. THIORIDAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 61786-673_4aa11632-6c0b-1b87-e054-00144ff88e88 61786-673 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20160422 ANDA ANDA076939 REMEDYREPACK INC. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61786-674_48be395f-c5a1-664e-e054-00144ff88e88 61786-674 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20160421 ANDA ANDA078384 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 61786-679_3d58eb9d-1f43-06f4-e054-00144ff8d46c 61786-679 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20160506 ANDA ANDA078115 REMEDYREPACK INC. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 61786-680_48bc8512-f8c7-451b-e054-00144ff8d46c 61786-680 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20160504 NDA NDA008678 REMEDYREPACK INC. ISONIAZID 100 mg/1 Antimycobacterial [EPC] N 20181231 61786-681_48bc7d48-cab1-2455-e054-00144ff88e88 61786-681 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20160504 ANDA ANDA202556 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 61786-684_48bb8eef-739b-1a9b-e054-00144ff8d46c 61786-684 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20160509 ANDA ANDA090694 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-685_5297be3b-3a2e-015f-e054-00144ff88e88 61786-685 HUMAN OTC DRUG Adult Low Dose Aspirin Aspirin TABLET, DELAYED RELEASE ORAL 20160509 OTC MONOGRAPH FINAL part343 REMEDYREPACK INC. ASPIRIN 81 mg/1 N 20181231 61786-688_48bb8eef-734a-1a9b-e054-00144ff8d46c 61786-688 HUMAN PRESCRIPTION DRUG Trifluoperazine Hydrochloride trifluoperazine hydrochloride TABLET, FILM COATED ORAL 20160512 ANDA ANDA040209 REMEDYREPACK INC. TRIFLUOPERAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 61786-689_48bb14dd-7859-6f09-e054-00144ff8d46c 61786-689 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20160517 ANDA ANDA077797 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 61786-690_591a23d9-af1b-358b-e053-2a91aa0a6aa8 61786-690 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20160519 ANDA ANDA090798 REMEDYREPACK INC. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-691_591b47ab-5b32-acf7-e053-2991aa0adebf 61786-691 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20160519 ANDA ANDA201507 REMEDYREPACK INC. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 61786-692_591b616b-1253-0933-e053-2a91aa0a9289 61786-692 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20160519 ANDA ANDA076255 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-693_53fdc233-cd7e-3c19-e054-00144ff8d46c 61786-693 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20160517 ANDA ANDA078539 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 61786-694_6287725b-7845-9aad-e053-2a91aa0ae0da 61786-694 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20160519 ANDA ANDA075232 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20191231 61786-696_5c7daf8c-0b6f-e7cd-e053-2991aa0a762c 61786-696 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160517 ANDA ANDA090858 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-697_591c862b-7ffd-79b1-e053-2991aa0a4ce3 61786-697 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20160519 ANDA ANDA090749 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-698_591ca995-3cfd-1593-e053-2991aa0a5e17 61786-698 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20160519 ANDA ANDA076255 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-699_591ca995-3d60-1593-e053-2991aa0a5e17 61786-699 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20160519 ANDA ANDA077050 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 61786-701_4a682c2d-68c8-096d-e054-00144ff8d46c 61786-701 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20160517 ANDA ANDA090564 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 61786-702_591dc28f-04d1-0671-e053-2a91aa0a26ca 61786-702 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160519 ANDA ANDA075360 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-703_63018b9e-ace4-0922-e053-2a91aa0a10a5 61786-703 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160518 ANDA ANDA075932 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 61786-704_4897a211-d519-32f2-e054-00144ff8d46c 61786-704 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20160518 ANDA ANDA078888 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 61786-705_592e53e6-94b7-4d8a-e053-2991aa0aa9dc 61786-705 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 20160519 NDA NDA020272 REMEDYREPACK INC. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-706_592e53e6-956a-4d8a-e053-2991aa0aa9dc 61786-706 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 20160519 NDA NDA020272 REMEDYREPACK INC. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-708_3d43441a-a1d3-02b4-e054-00144ff88e88 61786-708 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20160519 ANDA ANDA090294 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 61786-711_488964ab-3e59-3cbf-e054-00144ff8d46c 61786-711 HUMAN OTC DRUG DOK DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20160519 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. DOCUSATE SODIUM 250 mg/1 N 20181231 61786-712_592e53e6-961d-4d8a-e053-2991aa0aa9dc 61786-712 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20160524 ANDA ANDA204279 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 61786-714_592ee824-8c0c-2a9f-e053-2991aa0aebaa 61786-714 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20160525 ANDA ANDA076133 REMEDYREPACK INC. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-715_592ffbbb-6c76-0ada-e053-2991aa0a9bbd 61786-715 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20160525 ANDA ANDA078554 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-716_48881cbe-5b41-16c5-e054-00144ff8d46c 61786-716 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20160525 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-717_5da9ca94-c424-5a17-e053-2a91aa0a428d 61786-717 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20160608 ANDA ANDA076447 REMEDYREPACK INC. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 61786-721_4883427a-4ac3-1900-e054-00144ff8d46c 61786-721 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 20160526 NDA NDA020487 REMEDYREPACK INC. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 61786-723_592ffbbb-6ccd-0ada-e053-2991aa0a9bbd 61786-723 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20160627 ANDA ANDA074174 REMEDYREPACK INC. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61786-724_4882486b-f0e7-5211-e054-00144ff8d46c 61786-724 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20160527 ANDA ANDA071611 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 61786-726_487ff808-9a37-4480-e054-00144ff8d46c 61786-726 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20160531 ANDA ANDA078203 REMEDYREPACK INC. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61786-727_592ee824-8c64-2a9f-e053-2991aa0aebaa 61786-727 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20160531 ANDA ANDA207446 REMEDYREPACK INC. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-730_592ee824-8caf-2a9f-e053-2991aa0aebaa 61786-730 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20160607 ANDA ANDA074550 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 61786-731_6328c2f0-0cfb-67b4-e053-2991aa0abc93 61786-731 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20160607 ANDA ANDA076373 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 61786-732_592ffbbb-6d04-0ada-e053-2991aa0a9bbd 61786-732 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20160607 ANDA ANDA078235 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 61786-733_63004034-1241-c9c8-e053-2991aa0a359a 61786-733 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160607 ANDA ANDA075932 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 61786-734_6328c2f0-0d47-67b4-e053-2991aa0abc93 61786-734 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20160607 ANDA ANDA076373 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 61786-735_59316373-56a6-beb1-e053-2991aa0a3688 61786-735 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20160607 ANDA ANDA076133 REMEDYREPACK INC. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-736_5931ad36-87d5-283e-e053-2a91aa0a4e68 61786-736 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20160607 ANDA ANDA078235 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 61786-744_4a4edc06-0ba5-5471-e054-00144ff8d46c 61786-744 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20160613 ANDA ANDA063065 REMEDYREPACK INC. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 61786-746_48aa567a-2961-18cf-e054-00144ff8d46c 61786-746 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20160613 ANDA ANDA071017 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 61786-749_597eec6d-7cb3-d0ef-e053-2991aa0a0181 61786-749 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20160616 ANDA ANDA090960 REMEDYREPACK INC. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-750_597f786a-f5b7-3496-e053-2991aa0a7fdd 61786-750 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20160616 ANDA ANDA075227 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-751_48ab0a92-eb1e-3384-e054-00144ff8d46c 61786-751 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20160616 ANDA ANDA084363 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 61786-752_48aab8ba-05cf-2eb6-e054-00144ff8d46c 61786-752 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20160616 ANDA ANDA076958 REMEDYREPACK INC. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 61786-753_598032ce-5336-54bd-e053-2a91aa0a2a23 61786-753 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20160616 ANDA ANDA077614 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 61786-754_3aeae1e4-152d-3bb3-e054-00144ff8d46c 61786-754 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20160616 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61786-755_4a4da6a2-92e4-04d0-e054-00144ff8d46c 61786-755 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20160616 ANDA ANDA076958 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 61786-758_4a4da6a2-92ca-04d0-e054-00144ff8d46c 61786-758 HUMAN PRESCRIPTION DRUG Lithium Carbonate ER Lithium Carbonate TABLET ORAL 20160621 ANDA ANDA091616 REMEDYREPACK INC. LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] N 20181231 61786-759_598185f2-b8ea-8105-e053-2a91aa0ad483 61786-759 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20160624 OTC MONOGRAPH NOT FINAL part343 REMEDYREPACK INC. ACETAMINOPHEN 325 mg/1 N 20181231 61786-762_4a4e80d3-1e0f-41c5-e054-00144ff88e88 61786-762 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20160630 ANDA ANDA078106 REMEDYREPACK INC. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-763_6301febb-015c-1af5-e053-2991aa0aa309 61786-763 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160630 ANDA ANDA075932 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 61786-765_4a3dae8a-2dd5-5da3-e054-00144ff8d46c 61786-765 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20160706 ANDA ANDA091519 REMEDYREPACK INC. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 61786-768_598185f2-b8fc-8105-e053-2a91aa0ad483 61786-768 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20160712 ANDA ANDA089740 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 1 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 61786-771_59826177-cc68-2493-e053-2991aa0a5409 61786-771 HUMAN PRESCRIPTION DRUG Tivicay dolutegravir sodium TABLET, FILM COATED ORAL 20160713 NDA NDA204790 REMEDYREPACK INC. DOLUTEGRAVIR SODIUM 50 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 61786-772_59826177-cc94-2493-e053-2991aa0a5409 61786-772 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160714 ANDA ANDA090700 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 61786-774_5ae79885-175d-364b-e053-2a91aa0afcc6 61786-774 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20160712 ANDA ANDA091650 REMEDYREPACK INC. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61786-775_3e39cdfc-5180-6f3f-e054-00144ff88e88 61786-775 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20160713 ANDA ANDA077944 REMEDYREPACK INC. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61786-776_4a3b6a15-4107-3396-e054-00144ff88e88 61786-776 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20160718 ANDA ANDA091276 REMEDYREPACK INC. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-777_37e8e16f-9b92-704c-e054-00144ff8d46c 61786-777 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20160715 ANDA ANDA075731 REMEDYREPACK INC. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61786-778_382b84d8-6bd7-24ca-e054-00144ff88e88 61786-778 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium clorazepate dipotassium TABLET ORAL 20160715 ANDA ANDA071858 REMEDYREPACK INC. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61786-779_5990f8c7-e2c5-328d-e053-2a91aa0ab827 61786-779 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20160719 ANDA ANDA204197 REMEDYREPACK INC. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-780_59826177-ccbc-2493-e053-2991aa0a5409 61786-780 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20160720 ANDA ANDA204446 REMEDYREPACK INC. DOXYCYCLINE 100 mg/1 N 20181231 61786-782_481d1416-cfe9-0f12-e054-00144ff88e88 61786-782 HUMAN PRESCRIPTION DRUG Diazepam DIAZEPAM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160720 ANDA ANDA071583 REMEDYREPACK INC. DIAZEPAM 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61786-783_5990f8c7-e316-328d-e053-2a91aa0ab827 61786-783 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160725 ANDA ANDA202554 REMEDYREPACK INC. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61786-784_38147f3c-9632-03bd-e054-00144ff88e88 61786-784 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20160720 ANDA ANDA076118 REMEDYREPACK INC. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 61786-786_3839dfb7-0942-5665-e054-00144ff88e88 61786-786 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20160721 ANDA ANDA075731 REMEDYREPACK INC. CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61786-787_5991f52f-7331-c7f2-e053-2a91aa0a2571 61786-787 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20160726 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-788_59922417-0f30-4952-e053-2991aa0abd8f 61786-788 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20160726 ANDA ANDA077745 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-789_5994b1ee-b95f-00ec-e053-2a91aa0ac5ee 61786-789 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20160726 ANDA ANDA077565 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-790_599479d4-a568-c5d5-e053-2a91aa0aae4e 61786-790 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20160726 ANDA ANDA077565 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-791_5994b1ee-b9b2-00ec-e053-2a91aa0ac5ee 61786-791 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160726 ANDA ANDA203311 REMEDYREPACK INC. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 61786-792_599479d4-a5b7-c5d5-e053-2a91aa0aae4e 61786-792 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160726 ANDA ANDA203311 REMEDYREPACK INC. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 61786-793_599545b6-357b-2eca-e053-2991aa0a11b8 61786-793 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160726 ANDA ANDA203311 REMEDYREPACK INC. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 61786-794_59a63ed5-cf44-6c00-e053-2991aa0ae091 61786-794 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20160801 ANDA ANDA090843 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-795_3e398787-7004-6502-e054-00144ff88e88 61786-795 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20160727 UNAPPROVED DRUG OTHER REMEDYREPACK INC. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 E 20171231 61786-798_5d98c95c-128d-5b2d-e053-2a91aa0a7769 61786-798 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20160928 ANDA ANDA091625 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-801_4188d98d-ea96-1431-e054-00144ff8d46c 61786-801 HUMAN PRESCRIPTION DRUG ZYLOPRIM allopurinol TABLET ORAL 20161117 NDA NDA016084 REMEDYREPACK INC. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 61786-803_59a6bbe2-da41-7e0f-e053-2a91aa0ae362 61786-803 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20160803 ANDA ANDA089742 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 61786-804_59a76b0b-738d-6b9e-e053-2991aa0abb43 61786-804 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20160802 ANDA ANDA040756 REMEDYREPACK INC. FOLIC ACID 1 mg/1 N 20181231 61786-805_3907fe28-a476-31b5-e054-00144ff8d46c 61786-805 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20160801 ANDA ANDA075743 REMEDYREPACK INC. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61786-806_59a76b0b-73a6-6b9e-e053-2991aa0abb43 61786-806 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20160802 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61786-807_391837e9-783d-0b03-e054-00144ff8d46c 61786-807 HUMAN OTC DRUG Leader Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20160802 OTC MONOGRAPH FINAL part343 REMEDYREPACK INC. ASPIRIN 81 mg/1 E 20171231 61786-808_59a8b0d3-049f-162c-e053-2a91aa0ad9c9 61786-808 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20160809 ANDA ANDA089741 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 61786-811_59a8bcbc-ed5e-dc3a-e053-2a91aa0a0b4f 61786-811 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20160815 ANDA ANDA200839 REMEDYREPACK INC. LEVOFLOXACIN 750 mg/1 N 20181231 61786-812_4a291344-2cf5-2791-e054-00144ff8d46c 61786-812 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20160814 ANDA ANDA075520 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 61786-814_59a8bcbc-edbe-dc3a-e053-2a91aa0a0b4f 61786-814 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20160815 ANDA ANDA200839 REMEDYREPACK INC. LEVOFLOXACIN 250 mg/1 N 20181231 61786-815_4da0859e-1916-5f6d-e054-00144ff88e88 61786-815 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160811 ANDA ANDA076180 REMEDYREPACK INC. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61786-816_3a374a3b-2936-1bfc-e054-00144ff8d46c 61786-816 HUMAN PRESCRIPTION DRUG Rabeprazole sodium Rabeprazole sodium TABLET, DELAYED RELEASE ORAL 20160811 ANDA ANDA202376 REMEDYREPACK INC. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 61786-820_4a17e5dc-3026-3f64-e054-00144ff88e88 61786-820 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20160815 ANDA ANDA076958 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 61786-821_3a4a2799-5787-0923-e054-00144ff8d46c 61786-821 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20160815 ANDA ANDA075743 REMEDYREPACK INC. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61786-822_3a3a233d-8001-25d4-e054-00144ff8d46c 61786-822 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20160816 ANDA ANDA091426 REMEDYREPACK INC. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 61786-823_59a9a257-acaa-4b53-e053-2991aa0a6de2 61786-823 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20160817 NDA NDA021446 REMEDYREPACK INC. PREGABALIN 75 mg/1 N 20181231 61786-824_59a9f6d8-28a3-e285-e053-2991aa0a5bfa 61786-824 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20160817 NDA NDA021446 REMEDYREPACK INC. PREGABALIN 150 mg/1 N 20181231 61786-825_5a09f773-f343-4e07-e053-2991aa0a406c 61786-825 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20160823 ANDA ANDA090745 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-826_3a4a29f2-e6e5-2a88-e054-00144ff88e88 61786-826 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20160816 ANDA ANDA040644 REMEDYREPACK INC. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 E 20171231 61786-827_3a5e641f-0596-3d70-e054-00144ff8d46c 61786-827 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20160818 ANDA ANDA204314 REMEDYREPACK INC. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 61786-828_5a0a85f5-794b-d975-e053-2991aa0a2639 61786-828 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20160822 ANDA ANDA077745 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-829_6044df69-30e9-78ef-e053-2a91aa0a9843 61786-829 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20160818 ANDA ANDA203458 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 61786-831_481a37d8-4c9d-227a-e054-00144ff88e88 61786-831 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160819 ANDA ANDA076467 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 61786-833_3a7319fd-78d8-0a9c-e054-00144ff8d46c 61786-833 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20160819 ANDA ANDA075520 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61786-834_5a0c2626-2642-2bcd-e053-2991aa0a691a 61786-834 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20160823 ANDA ANDA077565 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-835_5a0cffbc-0132-0da6-e053-2a91aa0a67d4 61786-835 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20160822 ANDA ANDA079167 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61786-836_5a0e8958-c4a5-dab5-e053-2a91aa0ab3ee 61786-836 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20160822 ANDA ANDA079167 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61786-837_5a0e8958-c4e2-dab5-e053-2a91aa0ab3ee 61786-837 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20160822 ANDA ANDA079167 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61786-841_5a0f4362-9d94-d564-e053-2991aa0ab3ac 61786-841 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20160823 ANDA ANDA077745 REMEDYREPACK INC. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-843_5a0f4362-9de1-d564-e053-2991aa0ab3ac 61786-843 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20160829 NDA NDA022145 REMEDYREPACK INC. RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] N 20181231 61786-848_5a1ded98-fe50-d744-e053-2991aa0a33fa 61786-848 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20160830 NDA NDA021446 REMEDYREPACK INC. PREGABALIN 100 mg/1 N 20181231 61786-849_4a65192c-4a6e-5ded-e054-00144ff8d46c 61786-849 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20160831 ANDA ANDA088042 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 61786-850_5a37711e-5ba5-2c61-e053-2991aa0a3dc9 61786-850 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20160831 ANDA ANDA077836 REMEDYREPACK INC. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 61786-851_3b513d07-e807-6ddd-e054-00144ff8d46c 61786-851 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20160830 ANDA ANDA074761 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 61786-853_3b640308-8c7f-3ed2-e054-00144ff88e88 61786-853 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160831 ANDA ANDA204838 REMEDYREPACK INC. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 61786-854_5a45d0f2-7ebc-73a9-e053-2991aa0a3a3a 61786-854 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20160902 ANDA ANDA078902 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-855_5a460815-8e52-a5f0-e053-2991aa0ab67b 61786-855 HUMAN PRESCRIPTION DRUG Depakene Valproic Acid CAPSULE, LIQUID FILLED ORAL 20160902 NDA NDA018081 REMEDYREPACK INC. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 61786-857_5a5aec64-a5f9-4f2f-e053-2a91aa0a4248 61786-857 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160902 ANDA ANDA200834 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-858_5a46c12c-a8a5-2d43-e053-2991aa0abae3 61786-858 HUMAN PRESCRIPTION DRUG Horizant gabapentin enacarbil TABLET, EXTENDED RELEASE ORAL 20160902 NDA NDA022399 REMEDYREPACK INC. GABAPENTIN ENACARBIL 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61786-859_5a46774a-9d5c-5a43-e053-2991aa0a784c 61786-859 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20160902 ANDA ANDA072192 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 61786-860_5a49eee4-e825-5978-e053-2a91aa0a4836 61786-860 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine TABLET, FILM COATED ORAL 20160902 ANDA ANDA075755 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-861_5a49eee4-e8c8-5978-e053-2a91aa0a4836 61786-861 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20160902 ANDA ANDA078902 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-862_5a4a1ba5-95a5-5fda-e053-2a91aa0abec4 61786-862 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20160902 ANDA ANDA071209 REMEDYREPACK INC. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 61786-863_5a49eee4-e962-5978-e053-2a91aa0a4836 61786-863 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, EXTENDED RELEASE ORAL 20160902 NDA AUTHORIZED GENERIC NDA205122 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 61786-864_5a5a7f00-5bef-650c-e053-2991aa0a4bb5 61786-864 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20160902 ANDA ANDA076008 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 61786-865_3b6485c1-89f1-616d-e054-00144ff8d46c 61786-865 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20160831 ANDA ANDA077565 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-866_49d803d6-9f69-0b61-e054-00144ff8d46c 61786-866 HUMAN OTC DRUG Benadryl Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20160902 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 61786-867_3b6485c1-8a59-616d-e054-00144ff8d46c 61786-867 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20160831 ANDA ANDA077565 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-870_49d727b3-79b2-4fae-e054-00144ff8d46c 61786-870 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20160902 ANDA ANDA076497 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 61786-872_3dc0dc77-6307-2af8-e054-00144ff8d46c 61786-872 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20160906 ANDA ANDA075520 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61786-873_5a5b2f8a-2291-b7bc-e053-2a91aa0a4caa 61786-873 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160912 ANDA ANDA205064 REMEDYREPACK INC. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-874_46515607-fe05-7501-e054-00144ff8d46c 61786-874 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20160906 ANDA ANDA075994 REMEDYREPACK INC. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61786-875_49d53579-2b15-26e4-e054-00144ff88e88 61786-875 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20160915 ANDA ANDA076265 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61786-876_49d6338a-2284-4222-e054-00144ff88e88 61786-876 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20160915 ANDA ANDA076265 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61786-877_49d53579-2ad5-26e4-e054-00144ff88e88 61786-877 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20160908 ANDA ANDA076939 REMEDYREPACK INC. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61786-878_5a5b57b0-2d20-5efd-e053-2991aa0a1f01 61786-878 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160909 ANDA ANDA203145 REMEDYREPACK INC. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 61786-879_49d44219-d52e-0768-e054-00144ff88e88 61786-879 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160908 ANDA ANDA091629 REMEDYREPACK INC. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 61786-880_3c04f505-2d04-0bd6-e054-00144ff8d46c 61786-880 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20160908 ANDA ANDA077739 REMEDYREPACK INC. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61786-882_5a5bd11f-542f-5512-e053-2a91aa0a1e73 61786-882 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20160916 ANDA ANDA065470 REMEDYREPACK INC. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 61786-883_49c5bd9a-c41c-72d7-e054-00144ff88e88 61786-883 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20160915 ANDA ANDA071973 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61786-884_3c1b23ba-03fd-1b14-e054-00144ff8d46c 61786-884 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET ORAL 20160909 ANDA ANDA040712 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 61786-886_3c54e4b7-4b9c-38d8-e054-00144ff88e88 61786-886 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 20160912 ANDA ANDA075037 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 61786-887_5f9f6a83-26b8-3a0c-e053-2a91aa0af190 61786-887 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160919 ANDA ANDA090548 REMEDYREPACK INC. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61786-888_4950da99-8fda-459d-e054-00144ff8d46c 61786-888 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160912 ANDA ANDA076164 REMEDYREPACK INC. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61786-889_3c7d5c01-1222-55b7-e054-00144ff88e88 61786-889 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 20160914 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. SENNOSIDES A AND B 8.6 mg/1 E 20171231 61786-890_3c7e8a89-e5b2-4772-e054-00144ff8d46c 61786-890 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20160914 NDA NDA020983 REMEDYREPACK INC. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 61786-892_5a5ff44d-8c48-f799-e053-2991aa0a979d 61786-892 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20160922 ANDA ANDA040903 REMEDYREPACK INC. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 61786-893_5a98aed2-f994-1d42-e053-2991aa0ac851 61786-893 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20160923 ANDA ANDA077670 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-894_5a999d06-674d-4b28-e053-2991aa0a5ca1 61786-894 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20170920 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61786-900_5da9f94b-689b-21a0-e053-2991aa0a39aa 61786-900 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20160921 ANDA ANDA077135 REMEDYREPACK INC. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 61786-902_5d966e42-20aa-24ab-e053-2991aa0ab6c8 61786-902 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20160923 ANDA ANDA078203 REMEDYREPACK INC. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61786-903_63287581-9dab-f2f9-e053-2991aa0a6bc4 61786-903 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20160927 ANDA ANDA076373 REMEDYREPACK INC. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 61786-904_3d35ff2f-5660-1bfe-e054-00144ff8d46c 61786-904 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20160923 ANDA ANDA040412 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 61786-905_3d3614c0-5f7d-145e-e054-00144ff8d46c 61786-905 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20160923 ANDA ANDA201504 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 61786-906_5a9af792-3a10-2341-e053-2991aa0a25af 61786-906 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20160926 ANDA ANDA202357 REMEDYREPACK INC. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61786-907_476b6601-2b15-2a10-e054-00144ff88e88 61786-907 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 20160930 NDA AUTHORIZED GENERIC NDA020234 REMEDYREPACK INC. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 61786-908_61e61460-ebe5-9a92-e053-2a91aa0a76aa 61786-908 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20160927 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 61786-909_58f1b0e8-1a17-fd72-e053-2a91aa0aa428 61786-909 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20161004 ANDA ANDA075657 REMEDYREPACK INC. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 61786-910_5aaa4b5c-1872-19e0-e053-2a91aa0a24ad 61786-910 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 20161005 ANDA ANDA071756 REMEDYREPACK INC. OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61786-911_62ed3848-ae14-51fe-e053-2991aa0a149b 61786-911 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine Hydrochloride TABLET SUBLINGUAL 20161004 ANDA ANDA090819 REMEDYREPACK INC. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 61786-912_62ecaafc-e237-19f7-e053-2991aa0ad885 61786-912 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine Hydrochloride TABLET SUBLINGUAL 20170301 ANDA ANDA090819 REMEDYREPACK INC. BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 61786-913_3dfbc27c-e253-0ca9-e054-00144ff8d46c 61786-913 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate ipratropium bromide and albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20161003 ANDA ANDA202496 REMEDYREPACK INC. IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 2.5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 61786-914_3dfbfb71-1a2a-0c60-e054-00144ff8d46c 61786-914 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate ipratropium bromide and albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20161003 ANDA ANDA202496 REMEDYREPACK INC. IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 2.5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 61786-915_6318d14d-abe8-1f10-e053-2a91aa0ac034 61786-915 HUMAN PRESCRIPTION DRUG Cartia XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20161007 ANDA ANDA074752 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 61786-916_5aad77f6-e8a0-2194-e053-2991aa0a6ce0 61786-916 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20161102 ANDA ANDA202554 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61786-917_59b94f04-428f-2100-e053-2991aa0ab8f1 61786-917 HUMAN OTC DRUG Claritin-D 24 Hour Loratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE ORAL 20170914 NDA NDA020470 REMEDYREPACK INC. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 61786-918_3e24d300-5d95-52cd-e054-00144ff8d46c 61786-918 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20161005 ANDA ANDA078203 REMEDYREPACK INC. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61786-919_3e25755f-04c5-0521-e054-00144ff8d46c 61786-919 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20161005 ANDA ANDA077754 REMEDYREPACK INC. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61786-920_3e38249d-b3b7-3b8e-e054-00144ff88e88 61786-920 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20161006 ANDA ANDA074164 REMEDYREPACK INC. MICONAZOLE NITRATE 2 g/100g E 20171231 61786-921_3e39f08e-8e27-72a6-e054-00144ff88e88 61786-921 HUMAN OTC DRUG Calcium Polycarbophil 625 mg Calcium Polycarbophil 625 mg TABLET ORAL 20161006 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. CALCIUM POLYCARBOPHIL 625 mg/1 E 20171231 61786-923_3e4cd7a1-cb29-52c7-e054-00144ff8d46c 61786-923 HUMAN PRESCRIPTION DRUG Catapres clonidine hydrochloride TABLET ORAL 20161007 NDA NDA017407 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 61786-924_3e4c812d-4770-146b-e054-00144ff88e88 61786-924 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20161007 ANDA ANDA078406 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61786-925_5aaa96cf-7483-9f51-e053-2991aa0a6214 61786-925 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20161011 ANDA ANDA071524 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 61786-926_3e4e5e25-d505-5fe9-e054-00144ff88e88 61786-926 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20161007 ANDA ANDA201504 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 61786-927_3e52ea8f-6933-7496-e054-00144ff88e88 61786-927 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20161007 ANDA ANDA091497 REMEDYREPACK INC. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 61786-928_50ebb5f9-5a5c-4df0-e054-00144ff8d46c 61786-928 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20161012 ANDA ANDA089776 REMEDYREPACK INC. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 61786-932_3eb0c87a-9382-0b76-e054-00144ff8d46c 61786-932 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20161012 ANDA ANDA202383 REMEDYREPACK INC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 61786-933_3eb0c87a-935f-0b76-e054-00144ff8d46c 61786-933 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20161012 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61786-934_5aac47bb-778e-161d-e053-2a91aa0ae2e3 61786-934 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20161012 NDA NDA022047 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-935_63645781-242f-3e66-e053-2991aa0acdf4 61786-935 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20161012 ANDA ANDA090778 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 61786-936_61d36b27-1c75-7de3-e053-2991aa0a0f67 61786-936 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20161012 ANDA ANDA206556 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 61786-938_3eb19bcf-aa10-31d7-e054-00144ff8d46c 61786-938 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20161012 ANDA ANDA075657 REMEDYREPACK INC. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 61786-939_3eb34fc1-e711-2b17-e054-00144ff88e88 61786-939 HUMAN OTC DRUG Tolnaftate TOLNAFTATE CREAM TOPICAL 20161012 OTC MONOGRAPH FINAL part333C REMEDYREPACK INC. TOLNAFTATE 10 mg/g E 20171231 61786-940_48100d36-75db-3e17-e054-00144ff8d46c 61786-940 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20161014 ANDA ANDA204197 REMEDYREPACK INC. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-941_3f2a5f05-ae2f-3eb4-e054-00144ff8d46c 61786-941 HUMAN OTC DRUG SENNA TIME S DOCUSATE SODIUM-SENNOSIDES TABLET, FILM COATED ORAL 20161017 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; min/1 E 20171231 61786-943_5aacee14-cd34-6e1d-e053-2a91aa0a8694 61786-943 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20161018 ANDA ANDA077745 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-944_3f2a5f05-adfe-3eb4-e054-00144ff8d46c 61786-944 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20161018 ANDA ANDA075520 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61786-945_3f2a58a3-a4c4-2408-e054-00144ff88e88 61786-945 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20161018 ANDA ANDA075743 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61786-946_3f2a9499-97b5-2b76-e054-00144ff88e88 61786-946 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20161018 ANDA ANDA076122 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 E 20171231 61786-947_3f3cd2f7-a3f7-1afe-e054-00144ff8d46c 61786-947 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20161019 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61786-948_5fa240c5-0a12-45a9-e053-2a91aa0a4ae8 61786-948 HUMAN OTC DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20161019 ANDA ANDA091239 REMEDYREPACK INC. IBUPROFEN 200 mg/1 N 20181231 61786-949_3f68af78-50ce-2c56-e054-00144ff88e88 61786-949 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20161021 ANDA ANDA077397 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61786-950_5ac3e6e5-6893-c16d-e053-2991aa0a3a05 61786-950 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20161027 ANDA ANDA205064 REMEDYREPACK INC. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-951_3fa41270-3c75-53e4-e054-00144ff88e88 61786-951 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20161024 ANDA ANDA078106 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61786-953_505f17a2-a4e0-3d8c-e054-00144ff88e88 61786-953 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20161024 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-954_492b9288-9e64-5db3-e054-00144ff88e88 61786-954 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20161025 ANDA ANDA077253 REMEDYREPACK INC. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 61786-956_5ad26018-2f2f-4000-e053-2991aa0a41fb 61786-956 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20161031 ANDA ANDA077927 REMEDYREPACK INC. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-958_5ad2ceea-6b46-4a8e-e053-2991aa0a6737 61786-958 HUMAN PRESCRIPTION DRUG montelukast sodium montelukast sodium TABLET, FILM COATED ORAL 20161028 ANDA ANDA204290 REMEDYREPACK INC. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 61786-961_49db86fe-8eb7-0c0c-e054-00144ff88e88 61786-961 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20161027 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-962_40183d1e-513e-3c85-e054-00144ff88e88 61786-962 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20161028 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 61786-963_5ad298e3-b90c-5332-e053-2a91aa0a4b4a 61786-963 HUMAN OTC DRUG ROBAFEN COUGH FORMULA Guaifenesin SYRUP ORAL 20161031 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. GUAIFENESIN 100 mg/5mL N 20181231 61786-964_5fc6fb3d-25c3-6055-e053-2991aa0ac934 61786-964 HUMAN OTC DRUG Rabofen DM Guaifenesin and Dextromethorphan Hydrobromide SOLUTION ORAL 20161031 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 61786-965_40439c83-a8bc-4f51-e054-00144ff88e88 61786-965 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20161031 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61786-966_5ad3748c-749a-1e82-e053-2a91aa0a0f81 61786-966 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20161102 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61786-967_40431725-fb4c-6a62-e054-00144ff8d46c 61786-967 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20161101 ANDA ANDA202519 REMEDYREPACK INC. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 61786-968_4041eee8-a7bf-1da2-e054-00144ff88e88 61786-968 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 20161101 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV E 20171231 61786-969_41dbce52-c2a4-5144-e054-00144ff88e88 61786-969 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20161101 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61786-970_4c717b0f-02b0-464e-e054-00144ff8d46c 61786-970 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20161103 ANDA ANDA076899 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 61786-971_50222df4-5c34-1304-e054-00144ff88e88 61786-971 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20161107 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 61786-972_5ad3e974-a1af-eff7-e053-2991aa0aa203 61786-972 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20161103 ANDA ANDA076999 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 61786-973_4f0e8ccc-9f6c-1a2e-e054-00144ff8d46c 61786-973 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20161108 ANDA ANDA078414 REMEDYREPACK INC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 61786-974_5ad46800-ad5f-1a86-e053-2991aa0a0add 61786-974 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET, FILM COATED ORAL 20161108 ANDA ANDA075973 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 61786-975_5ad47539-d531-de1f-e053-2a91aa0ac795 61786-975 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20161108 ANDA ANDA077745 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-976_5ad47539-d57b-de1f-e053-2a91aa0ac795 61786-976 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20161108 ANDA ANDA090564 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 61786-977_5ae9b4d4-3493-1e2e-e053-2991aa0ae520 61786-977 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20161108 ANDA ANDA077745 REMEDYREPACK INC. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 61786-978_406c2bbd-4b1f-1237-e054-00144ff88e88 61786-978 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20161103 ANDA ANDA076122 REMEDYREPACK INC. MIRTAZAPINE 30 mg/1 E 20171231 61786-979_407fef20-22e2-07de-e054-00144ff8d46c 61786-979 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161104 ANDA ANDA084916 REMEDYREPACK INC. DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61786-980_407fc29e-6af2-1191-e054-00144ff8d46c 61786-980 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20161104 ANDA ANDA077563 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61786-981_5ad67e74-d80e-4026-e053-2a91aa0a14b2 61786-981 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20161115 ANDA ANDA078181 REMEDYREPACK INC. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 61786-982_575f3350-a775-4e20-e053-2991aa0a7aba 61786-982 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20161107 ANDA ANDA078250 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61786-984_4facd079-913f-0d85-e054-00144ff88e88 61786-984 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET ORAL 20161108 ANDA ANDA090092 REMEDYREPACK INC. ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61786-985_40cfd13a-5754-1838-e054-00144ff88e88 61786-985 HUMAN OTC DRUG Chlorpheniramine Maleate 4 mg Chlorpheniramine Maleate TABLET ORAL 20161108 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 61786-986_4faccb64-e2cb-5617-e054-00144ff8d46c 61786-986 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20161108 ANDA ANDA076194 REMEDYREPACK INC. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 61786-988_40f8b9e9-27b6-6cb1-e054-00144ff8d46c 61786-988 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20161110 ANDA ANDA064048 REMEDYREPACK INC. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 61786-989_40f8b8d1-a192-54b0-e054-00144ff88e88 61786-989 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20161110 ANDA ANDA078384 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 61786-990_5ad67e74-d838-4026-e053-2a91aa0a14b2 61786-990 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20161116 ANDA ANDA071321 REMEDYREPACK INC. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61786-991_4f1dc46b-87e6-3dc5-e054-00144ff8d46c 61786-991 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20161114 ANDA ANDA076301 REMEDYREPACK INC. LORATADINE 10 mg/1 N 20181231 61786-992_414c0e41-6b1e-57ad-e054-00144ff8d46c 61786-992 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20161114 ANDA ANDA071209 REMEDYREPACK INC. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] E 20171231 61786-993_414c1377-ed69-5604-e054-00144ff8d46c 61786-993 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20161114 ANDA ANDA077397 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61786-994_60b4a2ad-f704-08d1-e053-2a91aa0aaa83 61786-994 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161114 ANDA ANDA074993 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 61786-995_51034ce3-5e46-1a05-e054-00144ff88e88 61786-995 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 20161115 ANDA ANDA062500 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 61786-996_5ae91059-59fe-2125-e053-2991aa0a8b6c 61786-996 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20161116 ANDA ANDA077627 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 61786-997_418646cd-d1ba-1dda-e054-00144ff88e88 61786-997 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20161115 ANDA ANDA076265 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61786-999_4186aadf-b775-2570-e054-00144ff8d46c 61786-999 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20161116 ANDA ANDA202383 REMEDYREPACK INC. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 61787-062_e70bcb6c-6ffb-474f-b388-7a6c8cc8c146 61787-062 HUMAN OTC DRUG Diabetic Tussin DM Dextromethorphan hydrobromide and Guaifenesin LIQUID ORAL 19970501 OTC MONOGRAPH FINAL part341 Health Care Products DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 61787-063_4b727b03-cd92-49f7-b30c-38b2610ff059 61787-063 HUMAN OTC DRUG Diabetic Tussin Expectorant Guaifenesin LIQUID ORAL 19960101 OTC MONOGRAPH FINAL part341 Health Care Products GUAIFENESIN 100 mg/5mL E 20171231 61787-064_fd69e58d-a0cd-447b-b20e-681b12839907 61787-064 HUMAN OTC DRUG Diabetic Tussin DM Maximum Strength Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 19950703 OTC MONOGRAPH FINAL part341 Health Care Products DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL E 20171231 61787-423_40e7a942-c9ae-487f-b805-37b26c1ec7f7 61787-423 HUMAN OTC DRUG Zostrix Foot Pain Relief Capsaicin CREAM TOPICAL 20120904 OTC MONOGRAPH NOT FINAL part348 Health Care Products CAPSAICIN .25 mg/g E 20171231 61787-442_d88419df-456d-4f22-b86d-d8c6584422b1 61787-442 HUMAN OTC DRUG Zostrix Original Strength Capsaicin CREAM TOPICAL 20060109 OTC MONOGRAPH NOT FINAL part348 Health Care Products CAPSAICIN .25 mg/g E 20171231 61787-443_cd238ca3-bb8e-4c67-905d-404a4a38b823 61787-443 HUMAN OTC DRUG ZOSTRIX HP Capsaicin CREAM TOPICAL 20060109 OTC MONOGRAPH NOT FINAL part348 Health Care Products CAPSAICIN .75 mg/g E 20171231 61787-452_dad732cb-4936-433c-9bb0-5a0267f8e46c 61787-452 HUMAN OTC DRUG Diabetic Tussin Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl LIQUID ORAL 20100801 OTC MONOGRAPH FINAL part341 Health Care Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE 325; 10; 12.5 mg/5mL; mg/5mL; mg/5mL E 20171231 61787-482_8e61d498-8697-44be-93b0-feedaead9ae3 61787-482 HUMAN OTC DRUG Nasal Ease Allergy Reliever Potassium Dichromate POWDER NASAL 20090803 UNAPPROVED HOMEOPATHIC Health Care Products POTASSIUM DICHROMATE 200 [AU]/5.1g E 20171231 61787-499_cf1001ec-b069-4d51-82e7-646a9583a43a 61787-499 HUMAN OTC DRUG Zostrix Hot and Cold Therapy System capsaicin and menthol KIT 20120808 OTC MONOGRAPH NOT FINAL part348 Health Care Products E 20171231 61787-506_603dcdd7-fd70-63ae-e053-2a91aa0a957e 61787-506 HUMAN OTC DRUG Sinus Busters Sinus Busters SPRAY NASAL 20121201 UNAPPROVED HOMEOPATHIC Akorn Consumer Health RED PEPPER 4 [hp_X]/20mL N 20181231 61787-556_b4b89923-ab66-41be-8e27-905573afa948 61787-556 HUMAN OTC DRUG Zostrix High Potency Foot Pain Relief capsaicin CREAM TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part348 Health Care Products CAPSAICIN .75 mg/g E 20171231 61787-557_006d3c32-0a88-4454-aa0f-5dcc2ba9a222 61787-557 HUMAN OTC DRUG Zostrix Joint and Arthritis Pain Relief Capsaicin and Menthol CREAM TOPICAL 20131112 OTC MONOGRAPH NOT FINAL part348 Health Care Products CAPSAICIN; MENTHOL .25; 20 mg/g; mg/g E 20171231 61787-558_1085c67c-ce32-4d7a-a295-7caf524a0cff 61787-558 HUMAN OTC DRUG Diaderm Antifungal undecylenic acid CREAM TOPICAL 20131112 OTC MONOGRAPH FINAL part333C Health Care Products UNDECYLENIC ACID .1 g/g E 20171231 61791-126_55bcafbe-c613-4ab5-809d-d601838882b3 61791-126 HUMAN OTC DRUG REVITALIZING MOISTURIZING Sunscreen SPF 20 OCTOCRYLENE and OCTINOXATE and AVOBENZONE CREAM TOPICAL 20150902 OTC MONOGRAPH FINAL part352 GENOME COSMETICS, LLC OCTOCRYLENE; OCTINOXATE; AVOBENZONE 10; 7.5; 3 g/100g; g/100g; g/100g E 20171231 61811-0001_e22c1146-96eb-4f41-bbfc-6d66c180ff63 61811-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950505 UNAPPROVED MEDICAL GAS Bennett Medical Services OXYGEN 99 L/100L E 20171231 61821-001_51786cc3-a029-4ced-9a17-e8feac543816 61821-001 HUMAN OTC DRUG DIE DA WAN HUA PAIN RELIEVING TURPENTINE OIL TOPICAL 20030508 OTC MONOGRAPH NOT FINAL part348 GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL CO., LTD TURPENTINE 6 g/100mL N 20181231 61821-051_a1352d12-4677-4d4e-a91c-bb902edf7dfa 61821-051 HUMAN OTC DRUG EXTRA STRENGTH HUA TUO MEDICATED PLASTER CAMPHOR, MENTHOL, METHYL SALICYLATE PLASTER TOPICAL; TRANSDERMAL 20130617 OTC MONOGRAPH NOT FINAL part348 GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY CAMPHOR (SYNTHETIC); MENTHOL; MENTHYL SALICYLATE, (+/-)- 8.3; 3.32; 13.84 g/1; g/1; g/1 E 20171231 61821-052_8d4d6a2d-a552-4ee4-874b-10e4f6d45ed5 61821-052 HUMAN OTC DRUG DIEDA FENGSHI GAO MEDICATED PLASTER CAMPHOR, MENTHOL, METHYL SALICYLATE PLASTER TOPICAL; TRANSDERMAL 20130617 OTC MONOGRAPH NOT FINAL part348 GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARMACEUTICAL COMPANY CAMPHOR (SYNTHETIC); MENTHOL; MENTHYL SALICYLATE, (+/-)- 8.3; 3.32; 13.84 g/1; g/1; g/1 N 20181231 61821-100_244a3007-842e-45ec-8997-0652cacef416 61821-100 HUMAN OTC DRUG Hua Tuo Medicated Plaster Extra Strength Menthol Camphor PATCH TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part348 Guangzhou Jing Xiu Tang Pharmaceutical Company Limited MENTHOL; CAMPHOR (SYNTHETIC) 3; 10 g/1; g/1 N 20181231 61822-0045_fae1a956-099f-49e9-8b05-5e3f5c6b095f 61822-0045 HUMAN OTC DRUG WU YANG BRAND MEDICATED PLASTER MENTHOL, METHYL SALICYLATE PLASTER TOPICAL; TRANSDERMAL 20011019 OTC MONOGRAPH NOT FINAL part348 GUANGZHOU BAIYUNSHAN PHARMACEUTICAL CO., LTD. BAIYUNSHAN HEJIGONG PHARMACEUTICAL FACTORY MENTHOL; METHYL SALICYLATE 6; 10 g/1; g/1 N 20181231 61822-0046_634c815d-4401-4194-81eb-4b6e350f6554 61822-0046 HUMAN OTC DRUG 701 DIEDA ZHENGTONG YAOGAO MEDICATED PLASTER CAMPHOR , MENTHOL , METHYL SALICYLATE PLASTER TOPICAL; TRANSDERMAL 20011015 OTC MONOGRAPH NOT FINAL part348 GUANGZHOU BAIYUNSHAN PHARMACEUTICAL CO., LTD. BAIYUNSHAN HEJIGONG PHARMACEUTICAL FACTORY CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 8; 10 g/1; g/1; g/1 N 20181231 61822-0047_45c54fea-0fa5-42c0-8400-b783e3f36f40 61822-0047 HUMAN OTC DRUG YAT TIP TOR SALICYLIC ACID PLASTER TOPICAL; TRANSDERMAL 20040426 OTC MONOGRAPH FINAL part358F GUANGZHOU BAIYUNSHAN PHARMACEUTICAL CO., LTD. BAIYUNSHAN HEJIGONG PHARMACEUTICAL FACTORY SALICYLIC ACID 40 g/1 N 20181231 61825-165_26b22a08-e663-4770-8a5d-865aa208fe5a 61825-165 HUMAN PRESCRIPTION DRUG Doral Quazepam TABLET ORAL 20170719 NDA NDA018708 Galt Pharmaceuticals LLC QUAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61825-701_40a1a405-5aa4-4392-847a-0533848737a1 61825-701 HUMAN OTC DRUG Lidocaine 4% Cream Lidocaine CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part348 Galt Pharmaceuticals LLC LIDOCAINE 4 g/100g N 20181231 61827-056_7e6e44d2-1a49-43a4-a037-9028d9399171 61827-056 HUMAN OTC DRUG Spring Grove Unscented Hand Sanitizer Spring Grove Unscented Hand Sanitizer SOLUTION TOPICAL 20131105 OTC MONOGRAPH NOT FINAL part333A Saalfeld Paper ALCOHOL 62.5 mL/100mL E 20171231 61830-001_2b56c3b7-4796-4712-bb95-0a5b7632e1d2 61830-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140627 NDA NDA205840 Gemstone Gas LLC OXYGEN 99 L/100L N 20181231 61834-0001_fe05f007-88e3-4501-92fe-13ff1060ec05 61834-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS J & A Medical Home Care Inc. OXYGEN 99 L/100L E 20171231 61852-046_e154904f-045d-407e-a148-5b57049b209a 61852-046 HUMAN OTC DRUG swiss hand guard antiseptic handwash antibacterial Alcohol GEL TOPICAL 20120131 OTC MONOGRAPH FINAL part333A OPI Products In ALCOHOL 80.4 mL/120mL E 20171231 61852-146_786468b6-1d76-4c0d-b86a-847e05b60e59 61852-146 HUMAN OTC DRUG Swiss Hand Guard antiseptic handwash antibacterial Alcohol GEL TOPICAL 20170821 OTC MONOGRAPH NOT FINAL part333A OPI Products Inc. ALCOHOL 62.5 g/100mL N 20181231 61852-637_785c0b14-8935-4688-8df3-309543d8a7f8 61852-637 HUMAN OTC DRUG SEPHORA BY OPI MOISTURIZING HAND SANITIZER ALCOHOL SPRAY TOPICAL 20100722 OTC MONOGRAPH FINAL part333 OPI Products Inc. ALCOHOL 65 mL/100mL E 20171231 61852-977_dfb73c06-c7e7-4e47-aff8-dd2a1993eb16 61852-977 HUMAN OTC DRUG MANICURE BY OPI - FINISHING BUTTER OCTINOXATE, OXYBENZONE CREAM TOPICAL 20100722 OTC MONOGRAPH FINAL part352 OPI Products, Inc OCTINOXATE; OXYBENZONE 7.5; 3.5 mL/100mL; mL/100mL E 20171231 61852-978_8c96a39b-29c7-4d2d-ab52-546aa488c362 61852-978 HUMAN OTC DRUG MANICURE BY OPI - FINISHING BUTTER OCTINOXATE, OXYBENZONE CREAM TOPICAL 20100722 OTC MONOGRAPH FINAL part352 OPI Products, Inc OCTINOXATE; OXYBENZONE 7.5; 3.5 mL/100mL; mL/100mL E 20171231 61856-101_b07db527-e777-41f7-b783-2fb77ec54433 61856-101 HUMAN OTC DRUG TOY CLEANER MIST ANTIBACTERIAL BENZALKONIUM CHLORIDE SPRAY TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A WESTRIDGE LABORATORIES INC BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 61867-101_de2ac42e-008e-4d9a-9fc7-e40f28ebd216 61867-101 HUMAN OTC DRUG SOLE SERUM LIDOCAINE SPRAY TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part348 THE COMFORT LAB LLC LIDOCAINE 4 g/100mL E 20171231 61869-0001_4e8728f9-a77e-46b5-b183-9f9f08c0cf0c 61869-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040201 UNAPPROVED MEDICAL GAS Professional PRN LLC dba Northside Oxygen & Medical Equipment OXYGEN 99 L/100L E 20171231 61871-001_b2c143bb-fb95-4c28-a9a2-d4821aa93afe 61871-001 HUMAN OTC DRUG Novarnica camphor and menthol SPRAY TOPICAL 20140122 OTC MONOGRAPH NOT FINAL part348 Xcentrik Inc. CAMPHOR (NATURAL); MENTHOL 4; 8 g/100mL; g/100mL N 20181231 61871-005_e2789530-0c37-4ead-a36e-5b39a3879f09 61871-005 HUMAN OTC DRUG Novarnica Foot Pain Reliever camphor and menthol SPRAY TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part348 Xcentrik Inc. CAMPHOR (NATURAL); MENTHOL 4; 8 g/100mL; g/100mL N 20181231 61871-010_cc2dd82c-0feb-4718-8cf9-afb83bc83b40 61871-010 HUMAN OTC DRUG Novarnica Moisturizing Foot Cream menthol CREAM TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part348 Xcentrik Inc. MENTHOL 3 g/100g N 20181231 61874-002_c3aea9a2-4b17-403a-8aa8-4c3dcf358ac1 61874-002 HUMAN PRESCRIPTION DRUG EMLA lidocaine and prilocaine CREAM TOPICAL 19921230 20180430 NDA NDA019941 Allergan, Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 61874-075_bcdf96d7-6277-4d38-8910-7d8af44df293 61874-075 HUMAN PRESCRIPTION DRUG Viberzi Eluxadoline TABLET, FILM COATED ORAL 20151001 NDA NDA206940 ALLERGAN USA, INC. ELUXADOLINE 75 mg/1 mu-Opioid Receptor Agonist [EPC],Opioid mu-Receptor Agonists [MoA] CIV N 20181231 61874-100_bcdf96d7-6277-4d38-8910-7d8af44df293 61874-100 HUMAN PRESCRIPTION DRUG Viberzi Eluxadoline TABLET, FILM COATED ORAL 20151001 NDA NDA206940 ALLERGAN USA, INC. ELUXADOLINE 100 mg/1 mu-Opioid Receptor Agonist [EPC],Opioid mu-Receptor Agonists [MoA] CIV N 20181231 61874-115_73968081-834a-4d3c-8054-a37179cfe047 61874-115 HUMAN PRESCRIPTION DRUG Vraylar cariprazine CAPSULE, GELATIN COATED ORAL 20150917 NDA NDA204370 Allergan USA, Inc. CARIPRAZINE 1.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 61874-130_73968081-834a-4d3c-8054-a37179cfe047 61874-130 HUMAN PRESCRIPTION DRUG Vraylar cariprazine CAPSULE, GELATIN COATED ORAL 20150917 NDA NDA204370 Allergan USA, Inc. CARIPRAZINE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 61874-145_73968081-834a-4d3c-8054-a37179cfe047 61874-145 HUMAN PRESCRIPTION DRUG Vraylar cariprazine CAPSULE, GELATIN COATED ORAL 20150917 NDA NDA204370 Allergan USA, Inc. CARIPRAZINE 4.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 61874-160_73968081-834a-4d3c-8054-a37179cfe047 61874-160 HUMAN PRESCRIPTION DRUG Vraylar cariprazine CAPSULE, GELATIN COATED ORAL 20150917 NDA NDA204370 Allergan USA, Inc. CARIPRAZINE 6 mg/1 Atypical Antipsychotic [EPC] N 20181231 61874-170_73968081-834a-4d3c-8054-a37179cfe047 61874-170 HUMAN PRESCRIPTION DRUG Vraylar cariprazine KIT ORAL 20150917 NDA NDA204370 Allergan USA, Inc. N 20181231 61877-0001_8afaffe6-24dc-49f0-a3c3-cab7bec40ece 61877-0001 HUMAN OTC DRUG TESTALL Testosterone, HGH GEL TOPICAL 20141022 UNAPPROVED HOMEOPATHIC Strike First Nutrition TESTOSTERONE; SOMATROPIN 6; 30 [hp_X]/g; [hp_X]/g N 20181231 61877-0002_fc5ced69-fb31-451b-a393-5958c3c10d07 61877-0002 HUMAN OTC DRUG HGH Gel Glandula Suprarenalis Suis, Thyroidinum (Bovine), HGH GEL TOPICAL 20151002 UNAPPROVED HOMEOPATHIC Strike First Nutrition SUS SCROFA ADRENAL GLAND; THYROID, BOVINE; SOMATROPIN 6; 8; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 61877-0003_02e8f2e2-d17e-4e45-8b34-d10c98e7fac6 61877-0003 HUMAN OTC DRUG HGH Glandula Suprarenalis Suis, Thyroidinum (Bovine), HGH GEL TOPICAL 20160621 UNAPPROVED HOMEOPATHIC Strike First Nutrition SUS SCROFA ADRENAL GLAND; THYROID, BOVINE; SOMATROPIN 6; 8; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 61877-0004_74bbd1bc-8212-4f5e-88f1-be8de0bd9cfe 61877-0004 HUMAN OTC DRUG HGH Gel Glandula Suprarenalis Suis, Thyroidinum (Bovine), HGH GEL TOPICAL 20170907 UNAPPROVED HOMEOPATHIC Natural Life Foods Corporation dba XYGENYX SUS SCROFA ADRENAL GLAND; THYROID, BOVINE; SOMATROPIN 6; 8; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 61884-1001_77692e1d-b9af-4e80-ad1d-9f3db05df167 61884-1001 HUMAN OTC DRUG Sayak GLYCERIN CREAM TOPICAL 20140130 OTC MONOGRAPH FINAL part347 GMS GLYCERIN .02 g/g E 20171231 61888-0202_61e03e5f-933f-773f-e053-2991aa0a3dfb 61888-0202 HUMAN PRESCRIPTION DRUG Oxygen Refrigerated Liquid OXYGEN GAS RESPIRATORY (INHALATION) 20071018 NDA NDA206023 Elliot Hospital of the City of Manchester DBA: Home Medical Equipment and Infusion Services of Manchester & Southern N.H. OXYGEN .99 kg/kg N 20191231 61894-010_f96051b9-d1bd-4313-86ad-ad2adc49dce0 61894-010 HUMAN PRESCRIPTION DRUG Prestalia perindopril arginine, amlodipine besylate TABLET ORAL 20150126 NDA NDA205003 Symplmed Pharmaceuticals, LLC PERINDOPRIL ARGININE; AMLODIPINE BESYLATE 3.5; 2.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 61894-011_f96051b9-d1bd-4313-86ad-ad2adc49dce0 61894-011 HUMAN PRESCRIPTION DRUG Prestalia perindopril arginine, amlodipine besylate TABLET ORAL 20150126 NDA NDA205003 Symplmed Pharmaceuticals, LLC PERINDOPRIL ARGININE; AMLODIPINE BESYLATE 7; 5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 61894-012_f96051b9-d1bd-4313-86ad-ad2adc49dce0 61894-012 HUMAN PRESCRIPTION DRUG Prestalia perindopril arginine, amlodipine besylate TABLET ORAL 20150126 NDA NDA205003 Symplmed Pharmaceuticals, LLC PERINDOPRIL ARGININE; AMLODIPINE BESYLATE 14; 10 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 61903-001_51b66034-b74e-4993-9cf0-4b8e8b5c3cf9 61903-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20131101 UNAPPROVED MEDICAL GAS Deaconess Home Services dba Deaconess Home Medical Equipment & Infusion OXYGEN 99 L/100L E 20171231 61916-090_b682082a-e89f-4586-a104-664175818bcf 61916-090 HUMAN PRESCRIPTION DRUG Drospirenone and Ethinyl Estradiol Drospirenone and Ethinyl Estradiol KIT ORAL 20171026 ANDA ANDA203291 Pharmaceutics International, Inc. (Pii) N 20181231 61919-002_0f4b59e9-2438-4aa1-956d-8acc76f51cdf 61919-002 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE ORAL 20140101 NDA NDA022370 DIRECT RX TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-003_26e24bb8-dec7-2f31-e054-00144ff88e88 61919-003 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR TABLET ORAL 20140101 ANDA ANDA077309 DIRECT RX ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 61919-004_33465d20-c8c3-26f8-e054-00144ff8d46c 61919-004 HUMAN PRESCRIPTION DRUG FLUTICASONE FLUTICASONE SPRAY, METERED NASAL 20140101 ANDA ANDA078492 Direct RX FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61919-005_3335e124-ba19-24d5-e054-00144ff8d46c 61919-005 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET ORAL 20140101 ANDA ANDA074112 Direct Rx ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61919-006_b812a66c-dbb4-4d5b-b941-be5ecae914a7 61919-006 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET ORAL 20140101 ANDA ANDA078491 DIRECT RX ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61919-007_dff371f3-8e11-43c6-ab4d-a00da4b1c7c5 61919-007 HUMAN PRESCRIPTION DRUG CLOPIDOGREL CLOPIDOGREL TABLET, FILM COATED ORAL 20140101 ANDA ANDA090540 DIRECT RX CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 61919-008_aa32bdf2-bae2-4d94-9365-b00c4fbee9ba 61919-008 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE tablet TABLET ORAL 20140101 ANDA ANDA091179 Direct Rx PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 61919-009_3f3ec4a8-eeb1-5c80-e054-00144ff88e88 61919-009 HUMAN PRESCRIPTION DRUG MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET, FILM COATED ORAL 20140101 ANDA ANDA202717 DIRECT RX MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 61919-010_3f625f2a-4a04-4ef9-e054-00144ff88e88 61919-010 HUMAN PRESCRIPTION DRUG HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE CREAM TOPICAL 20140101 ANDA ANDA075666 DIRECT RX HYDROCORTISONE VALERATE 2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61919-011_bc07fdcc-a859-43e2-ad63-f6c20d811c51 61919-011 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20140101 ANDA ANDA040218 DIRECT RX AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61919-012_3335c3a2-26d3-4478-e054-00144ff88e88 61919-012 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA086009 Direct Rx AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61919-013_33362e67-3d14-3f1d-e054-00144ff8d46c 61919-013 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA086009 Direct Rx AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61919-014_4883ccdf-0e03-579d-e054-00144ff88e88 61919-014 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170214 ANDA ANDA077206 DIRECT RX SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61919-015_3f626e84-bacf-511d-e054-00144ff88e88 61919-015 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN POWDER, FOR SUSPENSION ORAL 20140101 ANDA ANDA065322 DIRECT RX AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-016_35bb9a75-990e-6515-e054-00144ff8d46c 61919-016 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN CAPSULE ORAL 20140101 ANDA ANDA062884 DIRECT RX AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-017_410c89e7-ce85-25ff-e054-00144ff88e88 61919-017 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN TABLET, FILM COATED ORAL 20140101 NDA NDA050754 Direct Rx AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-018_e23ea5f0-479a-46e6-b25b-3150f6bbed96 61919-018 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin powder, for suspension FOR SUSPENSION ORAL 20150101 ANDA ANDA061931 Direct RX AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-020_33c52f35-522b-5730-e054-00144ff88e88 61919-020 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20140101 ANDA ANDA091568 DIRECT RX AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 61919-021_4882de1c-7b6a-060d-e054-00144ff8d46c 61919-021 HUMAN PRESCRIPTION DRUG NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE NITROFURANTOIN MONOHYDRATE CAPSULE ORAL 20170214 NDA NDA020064 DIRECT RX NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 61919-022_ede271fa-922c-458f-8651-f8a47077f543 61919-022 HUMAN PRESCRIPTION DRUG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET ORAL 20140101 ANDA ANDA089175 DIRECT RX BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 61919-024_486fc2c3-8162-1e58-e054-00144ff88e88 61919-024 HUMAN PRESCRIPTION DRUG NITROFURANTION NITROFURANTION CAPSULE ORAL 20160415 ANDA ANDA201722 DIRECT RX NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 61919-025_3f63cd4b-805e-3d18-e054-00144ff8d46c 61919-025 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA078722 DIRECT RX CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-026_40f9338f-41b0-19a8-e054-00144ff8d46c 61919-026 HUMAN PRESCRIPTION DRUG BACLOFEN BACLOFEN TABLET ORAL 20140101 ANDA ANDA072234 Direct Rx BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 61919-027_40f9338f-41b0-19a8-e054-00144ff8d46c 61919-027 HUMAN PRESCRIPTION DRUG BACLOFEN BACLOFEN TABLET ORAL 20140101 ANDA ANDA072235 Direct Rx BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 61919-028_75d1dc2e-d527-4889-8eee-2be9443b644b 61919-028 HUMAN PRESCRIPTION DRUG ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET ORAL 20150101 ANDA ANDA090939 DIRECT RX ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-029_bf8cdb90-b894-4037-92b4-cb65a5504fa7 61919-029 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN CAPSULE ORAL 20150101 ANDA ANDA062713 DIRECT RX CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61919-030_4a3a5a4a-6263-13ed-e054-00144ff8d46c 61919-030 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM losartan potassium tablet TABLET ORAL 20150101 ANDA ANDA090467 Direct RX LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 61919-031_3424e921-fd49-2112-e054-00144ff88e88 61919-031 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE ORAL 20140101 ANDA ANDA040627 DIRECT RX BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 61919-032_48836437-c2c3-1ea2-e054-00144ff8d46c 61919-032 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET, FILM COATED ORAL 20170214 ANDA ANDA203458 DIRECT RX METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 61919-033_486b760b-7feb-306b-e054-00144ff8d46c 61919-033 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20170213 ANDA ANDA202929 DIRECT RX ESZOPICLONE 2 mg/1 CIV N 20181231 61919-035_4a629f05-43eb-4e47-e054-00144ff8d46c 61919-035 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN CAPSULE ORAL 20170220 ANDA ANDA065248 DIRECT RX CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 61919-036_339b5567-b328-5890-e054-00144ff88e88 61919-036 HUMAN PRESCRIPTION DRUG WELLBUTRIN SR BUPROPION HCL ER (SR) TABLET ORAL 20160503 ANDA ANDA078866 DIRECT RX BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 61919-037_2563ea9f-6e2a-2747-e054-00144ff88e88 61919-037 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET ORAL 20151125 ANDA ANDA075584 DirectRX BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 61919-038_40e2aedd-aaeb-598e-e054-00144ff8d46c 61919-038 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140101 ANDA ANDA078866 DIRECT RX BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 61919-039_9e2516b3-d57e-44a7-83b4-fa7512d56a1d 61919-039 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20140101 ANDA ANDA040755 Direct Rx CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV E 20171231 61919-040_26e1394c-f8b3-4405-e054-00144ff8d46c 61919-040 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET ORAL 20150101 ANDA ANDA090528 Direct Rx HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 61919-041_3388e873-132b-346b-e054-00144ff88e88 61919-041 HUMAN PRESCRIPTION DRUG AMOXIL AMOXICILLIN TABLET ORAL 20150605 ANDA ANDA065255 DIRECT RX AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-042_3710f96c-0f82-68c6-e054-00144ff88e88 61919-042 HUMAN PRESCRIPTION DRUG DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140101 ANDA ANDA203088 DIRECT RX DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-044_3f643251-f989-1a12-e054-00144ff88e88 61919-044 HUMAN PRESCRIPTION DRUG CEFUROXIME AXETIL CEFUROXIME AXETIL TABLET ORAL 20140101 ANDA ANDA065308 DIRECT RX CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61919-045_3f147b5e-e23a-1723-e054-00144ff8d46c 61919-045 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20140101 NDA NDA020998 DIRECT RX CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-046_40b7f4e0-35b2-1f4a-e054-00144ff8d46c 61919-046 HUMAN PRESCRIPTION DRUG CELEBREX CELEBREX CAPSULE ORAL 20140101 NDA NDA020998 Direct Rx CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-047_3f648a1c-2382-2569-e054-00144ff88e88 61919-047 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA091179 Direct Rx PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 61919-048_4833c5b9-649c-5e0a-e054-00144ff8d46c 61919-048 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20170210 ANDA ANDA090659 DIRECT RX OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 61919-049_3f64bf62-f019-2ba7-e054-00144ff88e88 61919-049 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN SUSPENSION ORAL 20140101 ANDA ANDA065234 DIRECT RX CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61919-050_33d3abb1-1453-2f5b-e054-00144ff8d46c 61919-050 HUMAN PRESCRIPTION DRUG KEFLEX CEPHALEXIN CAPSULE ORAL 20160523 ANDA ANDA062713 DIRECT RX CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61919-051_40b7d8a4-e83b-274a-e054-00144ff88e88 61919-051 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN CAPSULE ORAL 20140101 ANDA ANDA062791 DIRECT RX CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61919-052_3798dcd6-548b-0775-e054-00144ff8d46c 61919-052 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET ORAL 20140101 ANDA ANDA076670 DIRECT RX METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61919-053_486aa4c5-d308-48e7-e054-00144ff88e88 61919-053 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET ORAL 20170213 ANDA ANDA202800 DIRECT RX ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 61919-054_36defa19-7936-406b-8e8c-304081e7cade 61919-054 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN TABLET ORAL 20140101 ANDA ANDA076639 Direct Rx CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 61919-055_3f64e030-7f3c-3028-e054-00144ff88e88 61919-055 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET ORAL 20140101 ANDA ANDA077032 DIRECT RX CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-056_04fe05a8-eae7-4e24-9081-e982e5e08312 61919-056 HUMAN PRESCRIPTION DRUG CITALOPRAM CITALOPRAM TABLET ORAL 20150101 ANDA ANDA077032 DIRECT RX CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-057_269035f2-9ad1-4228-e054-00144ff8d46c 61919-057 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20150101 ANDA ANDA065061 Direct Rx CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 61919-058_6172feaf-0d0c-40bc-bb49-3aa5531d6d10 61919-058 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20140101 ANDA ANDA074869 DIRECT RX CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61919-059_03232912-585f-4927-ad8d-37d0a2828a9e 61919-059 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20140101 ANDA ANDA074569 Direct Rx CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61919-061_35e360f7-dbde-5dd9-e054-00144ff88e88 61919-061 HUMAN PRESCRIPTION DRUG Lamivudine Zidovudine Lamivudine Zidovudine TABLET ORAL 20150101 ANDA ANDA202418 Direct Rx LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 61919-062_4832f02d-289d-2fe6-e054-00144ff8d46c 61919-062 HUMAN PRESCRIPTION DRUG LORAZEPAM LORAZEPAM TABLET ORAL 20170210 ANDA ANDA078203 DIRECT RX LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61919-063_48a7e42b-9361-4ec6-e054-00144ff88e88 61919-063 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20170216 ANDA ANDA075932 DIRECT RX BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 61919-064_41715d9f-35a6-0708-e054-00144ff8d46c 61919-064 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20161116 ANDA ANDA090478 DIRECT RX CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-065_98767496-5afa-4b76-ae21-3f5dbd703fed 61919-065 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA090478 Direct Rx CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-066_35e360f7-dbcb-5dd9-e054-00144ff88e88 61919-066 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET ORAL 20150101 ANDA ANDA201506 Direct Rx VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 61919-067_5c4871da-3fd7-4b73-8b81-f2f3ddfc248e 61919-067 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET ORAL 20140101 ANDA ANDA090485 Direct Rx TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-068_48fc5196-2876-1c57-e054-00144ff8d46c 61919-068 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, FILM COATED ORAL 20170220 ANDA ANDA078993 DIRECT RX LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61919-069_4920adc6-d914-71b4-e054-00144ff8d46c 61919-069 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE (XL) BUPROPION HYDROCHLORIDE (XL) TABLET, EXTENDED RELEASE ORAL 20170222 ANDA ANDA206556 DIRECT RX BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 61919-072_3fd94697-44ef-7526-e054-00144ff8d46c 61919-072 HUMAN PRESCRIPTION DRUG DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM TABLET, FILM COATED ORAL 20140101 ANDA ANDA075219 DIRECT RX DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-073_f81dd77d-13af-4221-ae1c-4dda48f33c22 61919-073 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, COATED ORAL 20140101 ANDA ANDA076003 DIRECT RX TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-074_3fdaa3f6-dd9d-6a74-e054-00144ff88e88 61919-074 HUMAN PRESCRIPTION DRUG Diclofenac Sodium D/R Diclofenac Sodium D/R TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA075185 Direct RX DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-075_3fdaa3f6-dd9d-6a74-e054-00144ff88e88 61919-075 HUMAN PRESCRIPTION DRUG Diclofenac Sodium D/R Diclofenac Sodium D/R TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA075185 Direct RX DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-076_48a65c4c-bfef-1584-e054-00144ff88e88 61919-076 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170216 ANDA ANDA202446 DIRECT RX AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 61919-077_25c58c92-034c-0e8e-e054-00144ff8d46c 61919-077 HUMAN PRESCRIPTION DRUG DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA085082 DIRECT RX DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 61919-078_cd824743-f26e-4da4-a217-19a409f4da09 61919-078 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20150101 OTC MONOGRAPH FINAL part341 DIRECT RX DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 61919-079_40f2b7ee-b209-22eb-e054-00144ff8d46c 61919-079 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20140101 OTC MONOGRAPH FINAL part341 Direct Rx DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 E 20171231 61919-080_35e360f7-dbf3-5dd9-e054-00144ff88e88 61919-080 HUMAN PRESCRIPTION DRUG DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET ORAL 20150101 NDA AUTHORIZED GENERIC NDA012462 Direct Rx DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV E 20171231 61919-081_22b58356-005b-4cc1-8756-b2c9c478874a 61919-081 HUMAN PRESCRIPTION DRUG doxepin hydrochloride doxepin hydrochloride CAPSULE ORAL 20140101 ANDA ANDA070791 DIRECT RX DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61919-083_342625b3-da73-22b6-e054-00144ff8d46c 61919-083 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20140101 ANDA ANDA075350 DIRECT RX GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-086_4a62cc04-7074-549c-e054-00144ff8d46c 61919-086 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET ORAL 20170310 ANDA ANDA077397 DIRECT RX SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61919-087_4a62608c-4188-3473-e054-00144ff8d46c 61919-087 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20170310 ANDA ANDA078539 DIRECT RX ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 61919-088_4a2a1a9d-1ebe-5b90-e054-00144ff8d46c 61919-088 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20170307 ANDA ANDA071135 DIRECT RX DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61919-089_3450f9b0-2f80-73ff-e054-00144ff88e88 61919-089 HUMAN PRESCRIPTION DRUG XANAX ALPRAZOLAM TABLET ORAL 20160602 ANDA ANDA074112 DIRECT RX ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61919-090_3f654f17-052b-3185-e054-00144ff8d46c 61919-090 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ERYTHROMYCIN OINTMENT OPHTHALMIC 20140101 ANDA ANDA064067 Direct Rx ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 61919-091_49250bbf-fbff-07cd-e054-00144ff88e88 61919-091 HUMAN PRESCRIPTION DRUG METAXALONE METAXALONE TABLET ORAL 20170222 ANDA ANDA040445 DIRECT RX METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 61919-092_3fa26b9f-3457-38cd-e054-00144ff88e88 61919-092 HUMAN PRESCRIPTION DRUG ETODOLAC ETODOLAC TABLET, FILM COATED ORAL 20140101 ANDA ANDA075074 DIRECT RX ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-093_49873359-05f3-5f48-e054-00144ff88e88 61919-093 HUMAN PRESCRIPTION DRUG BACLOFEN BACLOFEN TABLET ORAL 20140101 ANDA ANDA078220 DIRECT RX BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 61919-094_44185ca1-5aca-0839-e054-00144ff88e88 61919-094 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED ORAL 20140101 ANDA ANDA200158 DIRECT RX DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 61919-095_34286c4a-e4bd-27d0-e054-00144ff8d46c 61919-095 HUMAN PRESCRIPTION DRUG BACLOFEN BACLOFEN TABLET ORAL 20140101 ANDA ANDA077241 DIRECT RX BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 61919-096_4a3a000d-baef-74a3-e054-00144ff88e88 61919-096 HUMAN PRESCRIPTION DRUG AZITHROMYCIN MONOHYDRATE AZITHROMYCIN MONOHYDRATE TABLET ORAL 20170308 ANDA ANDA065399 DIRECT RX AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 61919-097_4be31c8e-81eb-11d2-e054-00144ff8d46c 61919-097 HUMAN PRESCRIPTION DRUG MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET, CHEWABLE ORAL 20170329 ANDA ANDA090984 DIRECT RX MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 61919-098_267a6c21-70eb-24cd-e054-00144ff8d46c 61919-098 HUMAN PRESCRIPTION DRUG PHENAZOPYRIDINE HYDROCHLORIDE PHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED ORAL 20151209 UNAPPROVED DRUG OTHER DirectRX PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 E 20171231 61919-099_3f7dc4b0-ee3b-4c96-bbf3-249c304f3af6 61919-099 HUMAN PRESCRIPTION DRUG FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA075049 DIRECT RX FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-101_7d9af18b-1edc-4f6b-a4aa-5cca7652b600 61919-101 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20150101 ANDA ANDA077242 Direct Rx GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-102_26aba079-a66c-47c8-aa77-8ac655c7a025 61919-102 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20150101 ANDA ANDA077242 Direct Rx GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-102_7d9af18b-1edc-4f6b-a4aa-5cca7652b600 61919-102 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20150101 ANDA ANDA077242 Direct Rx GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-103_40e2f725-1c22-4652-e054-00144ff88e88 61919-103 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET ORAL 20140101 ANDA ANDA202764 DIRECT RX GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-104_786f7004-ac38-4b10-b5b7-cf63c199f0c0 61919-104 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET, FILM COATED ORAL 20140101 ANDA ANDA078926 DIRECT RX GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-106_3710f96c-0f71-68c6-e054-00144ff88e88 61919-106 HUMAN PRESCRIPTION DRUG gentamicin sulfate gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 20140101 ANDA ANDA062452 DIRECT RX GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 61919-107_4ac4f9c0-2592-0db9-e054-00144ff88e88 61919-107 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET ORAL 20170315 ANDA ANDA071881 DIRECT RX VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 61919-109_3fb12ec1-a30d-3da8-e054-00144ff88e88 61919-109 HUMAN PRESCRIPTION DRUG PHENOBARBITAL PHENOBARBITAL TABLET ORAL 20140101 UNAPPROVED DRUG OTHER DIRECT RX PHENOBARBITAL 64.8 mg/1 CIV E 20171231 61919-110_e9a5abb8-ba20-49af-985d-f7156d24562e 61919-110 HUMAN OTC DRUG GUAIFENESIN AND CODEINE PHOSPHATE GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION ORAL 20150101 OTC MONOGRAPH FINAL part341 DirectRX GUAIFENESIN; CODEINE PHOSPHATE 100; 10 mg/5mL; mg/5mL CV E 20171231 61919-111_4be2ae47-ce1f-6212-e054-00144ff88e88 61919-111 HUMAN PRESCRIPTION DRUG POLYCIN bacitracin zinc and polymyxin b sulfates OINTMENT OPHTHALMIC 20170329 ANDA ANDA065022 DIRECT RX POLYMYXIN B SULFATE; BACITRACIN ZINC 10000; 500 [USP'U]/g; [USP'U]/g Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Decreased Cell Wall Synthesis & Repair [PE] N 20181231 61919-112_4bb5ec0f-317d-0992-e054-00144ff8d46c 61919-112 HUMAN PRESCRIPTION DRUG LATANOPROST LATANOPROST SOLUTION/ DROPS OPHTHALMIC 20170327 ANDA ANDA090887 DIRECT RX LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 61919-113_4aecebf1-2f65-725d-e054-00144ff8d46c 61919-113 HUMAN PRESCRIPTION DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE neomycin, polymyxin b sulfates, dexamethasone OINTMENT OPHTHALMIC 20170317 ANDA ANDA062938 DIRECT RX DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 61919-114_35cb5fcd-f1c7-2dbc-e054-00144ff8d46c 61919-114 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20140101 ANDA ANDA040656 Direct Rx HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 61919-116_4bb5152e-c79b-35de-e054-00144ff88e88 61919-116 HUMAN OTC DRUG BACITRACIN BACITRACIN OINTMENT TOPICAL 20170327 OTC MONOGRAPH FINAL part333B DIRECT RX BACITRACIN 500 [USP'U]/g N 20181231 61919-117_4b7fcf0c-6d2d-20b2-e054-00144ff8d46c 61919-117 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170324 ANDA ANDA202446 DIRECT RX AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 61919-118_2427de30-b849-4a15-9b59-b5a47af7be04 61919-118 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET ORAL 20140101 ANDA ANDA040746 DIRECT RX HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] E 20171231 61919-119_4be28e4b-6cc5-6b26-e054-00144ff8d46c 61919-119 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20170329 ANDA ANDA202929 DIRECT RX ESZOPICLONE 1 mg/1 CIV N 20181231 61919-121_4d226b9a-bd9c-4bc0-e054-00144ff8d46c 61919-121 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20170414 ANDA ANDA201507 DIRECT RX HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 61919-122_28e47db8-9503-43db-a66f-407e26ebd1df 61919-122 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20150101 ANDA ANDA040804 DIRECT RX HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 61919-123_d1a72438-19cf-45ad-8349-c4676ec31483 61919-123 HUMAN OTC DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20140101 OTC MONOGRAPH NOT FINAL part343 DIRECT RX IBUPROFEN 200 mg/1 E 20171231 61919-124_34298d80-1f62-5881-e054-00144ff88e88 61919-124 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20140101 ANDA ANDA078558 Direct Rx IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-125_34298d80-1f62-5881-e054-00144ff88e88 61919-125 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20140101 ANDA ANDA078558 Direct Rx IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-126_34298d80-1f62-5881-e054-00144ff88e88 61919-126 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20140101 ANDA ANDA078558 Direct Rx IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-128_3f9d7802-8734-0fa6-e054-00144ff88e88 61919-128 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20140101 ANDA ANDA040715 DIRECT RX BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 61919-129_3f9d9149-19aa-4187-e054-00144ff8d46c 61919-129 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN CAPSULE ORAL 20140101 ANDA ANDA091240 Direct Rx INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-130_36e42def-cb54-32e6-e054-00144ff8d46c 61919-130 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN CAPSULE ORAL 20140101 ANDA ANDA091240 DIRECT RX INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-131_50bfe7b3-bfda-068b-e054-00144ff8d46c 61919-131 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20170530 ANDA ANDA071136 DIRECT RX DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61919-132_3fda9074-20e6-639c-e054-00144ff88e88 61919-132 HUMAN PRESCRIPTION DRUG HYDROXYCHLOROQUINE SULFATE HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED ORAL 20140101 ANDA ANDA040657 DIRECT RX HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] E 20171231 61919-133_3f9db864-2726-4b87-e054-00144ff8d46c 61919-133 HUMAN PRESCRIPTION DRUG HALOPERIDOL HALOPERIDOL TABLET ORAL 20140101 ANDA ANDA077580 DIRECT RX HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] E 20171231 61919-134_491102c1-f04c-4b7b-e054-00144ff8d46c 61919-134 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20170221 ANDA ANDA077056 DIRECT RX PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 61919-135_375cdfd0-7997-5a42-e054-00144ff88e88 61919-135 HUMAN PRESCRIPTION DRUG AMOXIL AMOXICILLIN TABLET ORAL 20160708 ANDA ANDA065256 DIRECT RX AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-136_54874d2d-2b14-20d9-e054-00144ff8d46c 61919-136 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20170717 ANDA ANDA075932 DIRECT RX BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 61919-138_2677db3c-f39e-47e0-e054-00144ff8d46c 61919-138 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE TABLET, FILM COATED ORAL 20140101 ANDA ANDA074754 DIRECT RX KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 61919-139_c092f9fc-5f53-443e-af28-52dfda33c906 61919-139 HUMAN PRESCRIPTION DRUG ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET ORAL 20150101 ANDA ANDA090939 Direct Rx ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-140_3f9ebab9-3795-36f5-e054-00144ff88e88 61919-140 HUMAN PRESCRIPTION DRUG LIDOCAINE VISCOUS LIDOCAINE VISCOUS SOLUTION ORAL; TOPICAL 20140101 ANDA ANDA088802 Direct RX LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 61919-142_28f11e46-1436-4068-9a7b-b7cb66a3ddae 61919-142 HUMAN OTC DRUG LORATADINE LORATADINE TABLET ORAL 20140101 ANDA ANDA076301 DIRECT RX LORATADINE 10 mg/1 E 20171231 61919-143_343d5211-54be-7414-e054-00144ff8d46c 61919-143 HUMAN PRESCRIPTION DRUG LORAZEPAM LORAZEPAM TABLET ORAL 20160601 ANDA ANDA078203 DIRECTRX LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61919-144_5488e98e-3956-017c-e054-00144ff8d46c 61919-144 HUMAN PRESCRIPTION DRUG SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET ORAL 20170717 ANDA ANDA090624 DIRECT RX SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 61919-145_d45e7d8f-f4ab-4273-962a-d44b4c5633da 61919-145 HUMAN PRESCRIPTION DRUG CEFUROXIME AXETIL CEFUROXIME AXETIL TABLET ORAL 20140101 ANDA ANDA065308 DIRECT RX CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61919-146_26a26538-9078-1e37-e054-00144ff8d46c 61919-146 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20140101 ANDA ANDA040659 DIRECT RX MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 61919-147_cb5d1f16-9d60-44d6-853c-51aff98c0923 61919-147 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20150101 ANDA ANDA086988 Direct RX METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-148_31508051-c9cc-149b-e054-00144ff88e88 61919-148 HUMAN PRESCRIPTION DRUG METHOCARBAMOL METHOCARBAMOL TABLET ORAL 20160322 ANDA ANDA086988 DIRECT RX METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-148_cb5d1f16-9d60-44d6-853c-51aff98c0923 61919-148 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20150101 ANDA ANDA086988 Direct RX METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-149_3fdacbdf-15ba-6a44-e054-00144ff88e88 61919-149 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20140101 ANDA ANDA040189 DIRECT RX METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61919-150_3fa059c8-0715-65a7-e054-00144ff8d46c 61919-150 HUMAN PRESCRIPTION DRUG METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA072801 DIRECT RX METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 61919-152_3fa0c924-e4cd-0e8f-e054-00144ff8d46c 61919-152 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET ORAL 20140101 ANDA ANDA070044 DIRECT RX METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 61919-153_af47237e-0bb9-435c-9e8d-e3e9f87b0a6d 61919-153 HUMAN PRESCRIPTION DRUG MIRTAZAPINE MIRTAZAPINE TABLET, FILM COATED ORAL 20150101 ANDA ANDA077666 DirectRX MIRTAZAPINE 15 mg/1 E 20171231 61919-154_3fa07d63-34aa-0486-e054-00144ff8d46c 61919-154 HUMAN PRESCRIPTION DRUG MIRTAZAPINE MIRTAZAPINE TABLET, FILM COATED ORAL 20140101 ANDA ANDA077666 DIRECT RX MIRTAZAPINE 30 mg/1 E 20171231 61919-155_3fa0cb4f-79a3-1062-e054-00144ff8d46c 61919-155 HUMAN PRESCRIPTION DRUG MIRTAZAPINE MIRTAZAPINE TABLET, FILM COATED ORAL 20140101 ANDA ANDA077666 Direct Rx MIRTAZAPINE 45 mg/1 E 20171231 61919-156_3fa173eb-e979-38c0-e054-00144ff8d46c 61919-156 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20140101 ANDA ANDA040355 DIRECT RX HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] E 20171231 61919-157_3fa1a19a-4a62-1fad-e054-00144ff88e88 61919-157 HUMAN PRESCRIPTION DRUG RAMIPRIL RAMIPRIL CAPSULE ORAL 20140101 ANDA ANDA077626 DIRECT RX RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61919-158_3fa1a19a-4a87-1fad-e054-00144ff88e88 61919-158 HUMAN PRESCRIPTION DRUG MUPIROCIN MUPIROCIN OINTMENT TOPICAL 20140101 ANDA ANDA065085 DIRECT RX MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 61919-159_2d8f206e-0854-43ca-e054-00144ff8d46c 61919-159 HUMAN PRESCRIPTION DRUG NABUMETONE NABUMETONE TABLET, FILM COATED ORAL 20160303 ANDA ANDA075189 DIRECT RX NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-159_7a760842-1752-4d83-825e-347e9f0a4290 61919-159 HUMAN PRESCRIPTION DRUG NABUMETONE NABUMETONE TABLET, FILM COATED ORAL 20150101 ANDA ANDA075189 Direct Rx NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-160_7a760842-1752-4d83-825e-347e9f0a4290 61919-160 HUMAN PRESCRIPTION DRUG NABUMETONE NABUMETONE TABLET, FILM COATED ORAL 20150101 ANDA ANDA075189 Direct Rx NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-161_48f6a32b-2214-6281-e054-00144ff8d46c 61919-161 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20170220 ANDA ANDA075994 DIRECT RX LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61919-162_3c646e39-db3c-40e1-e054-00144ff8d46c 61919-162 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20160829 ANDA ANDA078250 DIRECT RX NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-163_28bf7a84-e623-4e86-8e00-209e0fe3a77e 61919-163 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20140101 ANDA ANDA075927 Direct RX NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-164_4d9a253a-f015-4fab-e054-00144ff8d46c 61919-164 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN CAPSULE ORAL 20170420 ANDA ANDA091276 DIRECT RX INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61919-165_3fde1a74-4cd3-66ad-e054-00144ff88e88 61919-165 HUMAN PRESCRIPTION DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET ORAL 20140101 ANDA ANDA078432 DIRECT RX NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-166_4f5855b7-d3d5-3477-e054-00144ff8d46c 61919-166 HUMAN PRESCRIPTION DRUG BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET ORAL 20170512 ANDA ANDA202557 DIRECT RX BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 61919-167_27067d35-4e4c-4961-beaf-28e631b37349 61919-167 HUMAN PRESCRIPTION DRUG NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS OPHTHALMIC 20150101 ANDA ANDA064135 DIRECT RX NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61919-168_84183aa1-959e-44a6-8ac1-e0c9ad69b22f 61919-168 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20150101 NDA AUTHORIZED GENERIC NDA020998 DirectRX CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-169_4f40d5fa-ebcd-516c-e054-00144ff8d46c 61919-169 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET, FILM COATED ORAL 20170511 ANDA ANDA202801 DIRECT RX LEVOFLOXACIN 750 mg/1 N 20181231 61919-171_bfcaa834-9f8d-41ed-aa2d-7059b14cd9da 61919-171 HUMAN PRESCRIPTION DRUG NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE ORAL 20150101 ANDA ANDA074132 Direct Rx NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61919-172_3451eee6-e12a-0a48-e054-00144ff8d46c 61919-172 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20140101 ANDA ANDA079162 DIRECT RX TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-173_4f4083dc-54ff-109a-e054-00144ff88e88 61919-173 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN SODIUM TABLET ORAL 20170511 ANDA ANDA078250 DIRECT RX NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61919-175_bc784e9d-afc1-4107-a1e6-b733d00813a0 61919-175 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN SOLUTION/ DROPS OPHTHALMIC 20140101 ANDA ANDA076407 DIRECT RX OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 61919-176_4144b16e-5027-009d-e054-00144ff88e88 61919-176 HUMAN PRESCRIPTION DRUG OMEPRAZOLE DR OMEPRAZOLE DR CAPSULE, DELAYED RELEASE ORAL 20150101 ANDA ANDA076048 Direct Rx OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-177_26a62ccc-18fe-405c-e054-00144ff88e88 61919-177 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA040284 Direct RX ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-178_3fb3356a-cfcc-6897-e054-00144ff8d46c 61919-178 HUMAN PRESCRIPTION DRUG OXAPROZIN OXAPROZIN TABLET ORAL 20140101 ANDA ANDA075844 DIRECT RX OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-179_3fb41bbb-ff2a-22c6-e054-00144ff8d46c 61919-179 HUMAN PRESCRIPTION DRUG RAMIPRIL RAMIPRIL CAPSULE ORAL 20150101 ANDA ANDA077470 DirectRX RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61919-181_45a15eec-c38f-4825-9566-2d5c88d41d52 61919-181 HUMAN PRESCRIPTION DRUG PAROXETINE HYDROCHLORIDE ANHYDROUS PAROXETINE HYDROCHLORIDE ANHYDROUS TABLET, FILM COATED ORAL 20140101 ANDA ANDA075356 DIRECT RX PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-183_3784e189-f432-54d2-e054-00144ff8d46c 61919-183 HUMAN PRESCRIPTION DRUG ANAPROX NAPROXEN SODIUM TABLET ORAL 20160711 ANDA ANDA078314 DIRECT RX NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-184_40f8b8d1-a1d8-54b0-e054-00144ff88e88 61919-184 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20140101 UNAPPROVED DRUG OTHER Direct Rx PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 E 20171231 61919-185_f8495948-ec6f-49ad-8385-f3a79b64403e 61919-185 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate tablet TABLET ORAL 20150101 ANDA ANDA079153 DIRECT RX TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-186_40290cf7-99f6-177a-e054-00144ff88e88 61919-186 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA040555 DIRECT RX PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 61919-188_3fb44850-b94d-16bc-e054-00144ff88e88 61919-188 HUMAN PRESCRIPTION DRUG piroxicam piroxicam CAPSULE ORAL 20140101 ANDA ANDA074116 DIRECT RX PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-189_33c0fc7a-aa49-34ae-e054-00144ff8d46c 61919-189 HUMAN PRESCRIPTION DRUG TOPAMAX TOPIRAMATE TABLET ORAL 20160510 ANDA ANDA090162 DIRECT RX TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-190_ee68f001-9190-42d6-800c-345ca900c220 61919-190 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20150101 ANDA ANDA079162 DIRECT RX TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-191_3fb439b4-487c-092a-e054-00144ff8d46c 61919-191 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA083426 DIRECT RX PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 61919-192_549c7037-957f-068b-e054-00144ff8d46c 61919-192 HUMAN PRESCRIPTION DRUG NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE ORAL 20170718 ANDA ANDA203126 DIRECT RX NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 61919-193_549c92e1-114c-0203-e054-00144ff8d46c 61919-193 HUMAN PRESCRIPTION DRUG PIROXICAM PIROXICAM CAPSULE ORAL 20170718 ANDA ANDA207938 DIRECT RX PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61919-194_5daa7cf3-d88b-16a4-e053-2991aa0a4c08 61919-194 HUMAN PRESCRIPTION DRUG ESTRADIOL ESTRADIOL TABLET ORAL 20171110 ANDA ANDA040197 DirectRX ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 61919-196_3fb4796a-c5a0-31b1-e054-00144ff88e88 61919-196 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA091283 TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 61919-198_255ec9f0-d818-6b97-e054-00144ff88e88 61919-198 HUMAN PRESCRIPTION DRUG ESTRADIOL ESTRADIOL TABLET ORAL 20151125 ANDA ANDA040197 DirectRX ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 61919-199_5d530ee8-3e5d-4323-e053-2a91aa0a9c1f 61919-199 HUMAN PRESCRIPTION DRUG RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20171106 ANDA ANDA077824 Direct Rx RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 61919-202_bb5e2188-2ddd-46cb-ad72-ea2448c1dfe6 61919-202 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20150101 ANDA ANDA091568 DirectRX AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 61919-203_5976580d-300f-4ad6-ac7c-bd2385d8f8ff 61919-203 HUMAN PRESCRIPTION DRUG MUPIROCIN MUPIROCIN OINTMENT TOPICAL 20150101 ANDA ANDA065123 DirectRX MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 61919-204_50217b0f-a697-6c82-e054-00144ff88e88 61919-204 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20170522 ANDA ANDA075927 DIRECT RX NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61919-205_41447e2b-c6c4-18fc-e054-00144ff8d46c 61919-205 HUMAN OTC DRUG SENNA-LAX SENNA-LAX TABLET ORAL 20150101 OTC MONOGRAPH NOT FINAL part334 DirectRX SENNOSIDES A AND B 8.6 mg/1 E 20171231 61919-206_681dd26d-2489-43c1-a45e-a206dbc86a42 61919-206 HUMAN PRESCRIPTION DRUG SILVER SULFADIAZINE SILVER SULFADAZINE CREAM TOPICAL 20140101 NDA NDA018810 DIRECT RX SILVER SULFADIAZINE 10 mg/g E 20171231 61919-208_35e360f7-dc02-5dd9-e054-00144ff88e88 61919-208 HUMAN PRESCRIPTION DRUG HYRDROCODONE APAP HYRDROCODONE APAP TABLET ORAL 20150101 ANDA ANDA201013 Direct Rx HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] E 20171231 61919-209_3fc592f1-d43c-0aee-e054-00144ff88e88 61919-209 HUMAN PRESCRIPTION DRUG SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM SOLUTION/ DROPS OPHTHALMIC 20140101 ANDA ANDA040066 DIRECT RX SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 61919-210_d0286beb-809c-429d-aae2-f478f260cbfe 61919-210 HUMAN PRESCRIPTION DRUG SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET ORAL 20140101 ANDA ANDA071017 DIRECT RX SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 61919-211_43ca706a-27e1-2f93-e054-00144ff88e88 61919-211 HUMAN PRESCRIPTION DRUG SUNLINDAC SULINDAC TABLET ORAL 20140101 ANDA ANDA072051 Direct Rx SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-214_3fc5636e-2a4c-3bff-e054-00144ff8d46c 61919-214 HUMAN PRESCRIPTION DRUG TEMAZEPAM TEMAZEPAM CAPSULE ORAL 20140101 ANDA ANDA071638 DIRECT RX TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 61919-216_549d08f7-da3c-5873-e054-00144ff88e88 61919-216 HUMAN PRESCRIPTION DRUG PHENAZOPYRIDINE HYDROCHLORIDE PHENAZOPYRIDINE HYDROCHLORIDE TABLET, COATED ORAL 20170719 UNAPPROVED DRUG OTHER DIRECT RX PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 61919-217_5bd46f87-5e1b-2d23-e053-2a91aa0a8959 61919-217 HUMAN PRESCRIPTION DRUG HYDROXYZINE HCL HYDROXYZINE HCL TABLET ORAL 20171018 ANDA ANDA204279 DIRECT RX HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 61919-217_5cc3aaa6-e190-a116-e053-2991aa0a1422 61919-217 HUMAN PRESCRIPTION DRUG HYDROXYZINE HCL HYDROXYZINE HCL TABLET ORAL 20171030 ANDA ANDA204279 DIRECT RX HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 61919-218_3a051a70-853c-4ccf-aa6e-ed429fc6c0f2 61919-218 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20140101 ANDA ANDA078050 DIRECT RX ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 61919-220_e5424d7e-0818-49ec-a829-b79e1bd5262d 61919-220 HUMAN PRESCRIPTION DRUG TIZANIDINE TIZANIDINE TABLET ORAL 20140101 ANDA ANDA076533 Direct Rx TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 61919-221_e5424d7e-0818-49ec-a829-b79e1bd5262d 61919-221 HUMAN PRESCRIPTION DRUG TIZANIDINE TIZANIDINE TABLET ORAL 20140101 ANDA ANDA076533 Direct Rx TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 61919-222_26a18e81-a5e5-35d7-e054-00144ff88e88 61919-222 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, COATED, EXTENDED RELEASE ORAL 20140101 ANDA ANDA090174 DIRECT RX VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-224_5ed44f2b-d396-4d73-91af-98aa4cf22966 61919-224 HUMAN PRESCRIPTION DRUG TOBRAMYCIN TOBRAMYCIN SOLUTION ORAL 20140101 ANDA ANDA064052 Direct Rx TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 61919-225_5cc620a3-2d66-1ccf-e053-2a91aa0a1a91 61919-225 HUMAN PRESCRIPTION DRUG RABERPRAZOLE SODIUM D/R RABERPRAZOLE SODIUM D/R TABLET, DELAYED RELEASE ORAL 20171030 ANDA ANDA202376 DIRECT RX RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 61919-226_5cc817b3-b035-041b-e053-2a91aa0a4a30 61919-226 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20171030 ANDA ANDA084283 DIRECT RX PREDNISONE 50 mg/1 N 20181231 61919-227_5cc83a3e-46bd-3b58-e053-2a91aa0a3382 61919-227 HUMAN PRESCRIPTION DRUG ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE TABLET ORAL 20171030 ANDA ANDA090939 DIRECT RX ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61919-228_5cc95465-0135-d346-e053-2991aa0a23bb 61919-228 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20171030 ANDA ANDA091179 DIRECT RX PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 61919-229_3fc56e9b-52ed-3c01-e054-00144ff8d46c 61919-229 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA075964 Direct Rx TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-230_3fc5bc45-e2c8-4dc3-e054-00144ff8d46c 61919-230 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET ORAL 20140101 ANDA ANDA090485 DIRECT RX TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-232_402aa355-79cc-5ae1-e054-00144ff88e88 61919-232 HUMAN PRESCRIPTION DRUG TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA071523 DIRECT RX TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 61919-233_3fc95839-6c0c-1303-e054-00144ff88e88 61919-233 HUMAN PRESCRIPTION DRUG POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE SOLUTION/ DROPS OPHTHALMIC 20140101 NDA AUTHORIZED GENERIC NDA050567 DIRECT RX POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 61919-234_ea4ebe65-82a9-46fa-930c-1aebd9d161f2 61919-234 HUMAN PRESCRIPTION DRUG TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM TOPICAL 20140101 ANDA ANDA088042 DIRECT RX TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61919-235_402b3d67-a1f9-6bff-e054-00144ff88e88 61919-235 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20140101 ANDA ANDA040362 DIRECT RX PREDNISONE 10 mg/1 E 20171231 61919-236_5cc9842e-a8fd-d88a-e053-2a91aa0a1667 61919-236 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20171030 ANDA ANDA078916 DIRECT RX FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 61919-237_3fc9c085-8fd3-4bbe-e054-00144ff8d46c 61919-237 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 20140101 NDA NDA018578 DIRECT RX SILVER SULFADIAZINE 10 g/1000g E 20171231 61919-238_35e17692-7874-269a-e054-00144ff88e88 61919-238 HUMAN PRESCRIPTION DRUG NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA074132 DIRECT RX NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61919-239_5ccacb47-6349-6143-e053-2991aa0ac066 61919-239 HUMAN PRESCRIPTION DRUG LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM TABLET ORAL 20171030 ANDA ANDA090097 DIRECT RX LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 61919-240_96a48ad0-35e1-4dba-a564-2b0f4fb6939a 61919-240 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20150101 ANDA ANDA040218 DIRECT RX AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61919-243_6ea932a7-1ec3-4b41-b846-57f5321f2a6a 61919-243 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE ORAL 20140101 ANDA ANDA078003 DIRECT RX ESOMEPRAZOLE MAGNESIUM DIHYDRATE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-244_376084de-d361-5732-e054-00144ff88e88 61919-244 HUMAN PRESCRIPTION DRUG PHENTERMINE HCL PHENTERMINE HCL CAPSULE ORAL 20160711 ANDA ANDA091359 DIRECT RX PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 61919-245_26919045-087c-0efd-e054-00144ff8d46c 61919-245 HUMAN PRESCRIPTION DRUG LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED RELEASE ORAL 20140101 ANDA ANDA091269 DIRECT RX LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 61919-247_34613534-cc2b-3c36-e054-00144ff8d46c 61919-247 HUMAN PRESCRIPTION DRUG LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE SOLUTION OROPHARYNGEAL 20140101 ANDA ANDA040708 DIRECT RX LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 61919-248_f9819b4f-193e-42c0-bc6f-c1fda0ded940 61919-248 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN TABLET ORAL 20150101 ANDA ANDA040105 DirectRX OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 61919-249_2228459e-b229-435d-99c7-793f86fb82e1 61919-249 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20150101 ANDA ANDA079163 DirectRX DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 61919-250_2b57dfa7-f2c3-45ca-e054-00144ff8d46c 61919-250 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20160204 ANDA ANDA078181 DIRECT RX GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 61919-251_3c64148a-99ac-2bbd-e054-00144ff8d46c 61919-251 HUMAN PRESCRIPTION DRUG ETODOLAC ETODOLAC TABLET ORAL 20160829 ANDA ANDA076004 DIRECT RX ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-252_494d5207-1bf1-72fd-e054-00144ff88e88 61919-252 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20150101 ANDA ANDA075350 DirectRX GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 61919-253_5cccc071-9aa1-2995-e053-2991aa0a7f9a 61919-253 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20171030 ANDA ANDA090223 DIRECT RX FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61919-257_3fdaa7ca-3256-446d-e054-00144ff8d46c 61919-257 HUMAN PRESCRIPTION DRUG ATENOLOL ATENOLOL TABLET ORAL 20140101 ANDA ANDA077877 Direct Rx ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61919-260_3479aa8c-e9af-4f68-9bc9-6436f38890c8 61919-260 HUMAN PRESCRIPTION DRUG AZITHROMYCIN MONOHYDRATE AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED ORAL 20140101 ANDA ANDA065225 DIRECT RX AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 61919-261_343ae626-4423-4b47-96b7-6ab777c0cefa 61919-261 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20150101 ANDA ANDA078722 DIRECT RX CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-262_a7d38aeb-3bb8-4147-9ad8-44ecb8413b6b 61919-262 HUMAN PRESCRIPTION DRUG METAXALONE metaxalone tablet TABLET ORAL 20150101 ANDA ANDA203399 Direct RX METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 61919-263_7bc99758-11bc-4b1d-96a4-a30926d9dfd2 61919-263 HUMAN PRESCRIPTION DRUG TEMAZEPAM TEMAZEPAM CAPSULE ORAL 20150101 ANDA ANDA071456 DirectRX TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61919-264_3ce3d24a-aa52-4c3c-b8f1-499f91af3fcf 61919-264 HUMAN PRESCRIPTION DRUG TEMAZEPAM TEMAZEPAM CAPSULE ORAL 20150101 ANDA ANDA071457 DirectRX TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61919-266_3fdab720-2da2-6cae-e054-00144ff88e88 61919-266 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA070974 DIRECT RX CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 61919-267_26dc28bb-2a2f-62d6-e054-00144ff8d46c 61919-267 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET ORAL 20150101 ANDA ANDA078895 DirectRX CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 61919-268_2823a922-3218-6062-e054-00144ff88e88 61919-268 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET ORAL 20151229 ANDA ANDA078895 DirectRX CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 61919-269_35e360f7-dc11-5dd9-e054-00144ff88e88 61919-269 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20150101 ANDA ANDA088237 Direct Rx DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61919-272_6e5b3652-0803-4b82-afca-da76be9edafb 61919-272 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20150101 ANDA ANDA040682 Direct RX BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 61919-273_2fe3ae02-4bb8-4ebf-bf12-d9e6828ba46b 61919-273 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET ORAL 20150101 ANDA ANDA088629 DirectRX ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 61919-275_c4e749b0-47c2-4d50-abd1-8510c80934e2 61919-275 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20150101 ANDA ANDA077634 DirectRX ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 61919-276_31512ece-cb17-2a9a-e054-00144ff88e88 61919-276 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20160317 ANDA ANDA204446 DIRECT RX DOXYCYCLINE 100 mg/1 E 20171231 61919-277_260054b1-f94d-3e57-e054-00144ff88e88 61919-277 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20151203 ANDA ANDA075483 DirectRX ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 61919-279_105aff47-d5d5-49ce-9b35-98931adea22a 61919-279 HUMAN PRESCRIPTION DRUG ATENOLOL ATENOLOL TABLET ORAL 20150101 ANDA ANDA074056 DirectRX ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61919-280_3f3b21e0-5ba5-5b18-e054-00144ff88e88 61919-280 HUMAN PRESCRIPTION DRUG BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA076820 DIRECT RX BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 61919-281_26a12ef1-c0e9-36bb-e054-00144ff8d46c 61919-281 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20140101 ANDA ANDA075805 Direct Rx FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 61919-282_edbb2edf-03ed-487c-8c35-728a35c0a032 61919-282 HUMAN PRESCRIPTION DRUG FLUCONAZOLE FLUCONAZOLE TABLET ORAL 20140101 ANDA ANDA076077 DIRECT RX FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 61919-284_3fdcbef4-a7e0-4c52-e054-00144ff8d46c 61919-284 HUMAN PRESCRIPTION DRUG FUROSEMIDE FUROSEMIDE TABLET ORAL 20140101 ANDA ANDA076796 DIRECT RX FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 61919-286_49396d10-3d9b-2dfd-e054-00144ff88e88 61919-286 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20140101 ANDA ANDA074226 DIRECT RX GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 61919-286_4948accf-b5be-49cf-e054-00144ff88e88 61919-286 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20140101 ANDA ANDA077820 DIRECT RX GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 61919-287_48f7b22c-e21f-215c-e054-00144ff8d46c 61919-287 HUMAN PRESCRIPTION DRUG GLIPIZIDE GLIPIZIDE TABLET ORAL 20170220 ANDA ANDA075795 DIRECT RX GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 61919-288_304f1d5a-2190-51ae-e054-00144ff88e88 61919-288 HUMAN PRESCRIPTION DRUG CITALOPRAM CITALOPRAM TABLET, FILM COATED ORAL 20160322 ANDA ANDA077289 DIRECT RX CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-291_3fde8fa2-ca87-0118-e054-00144ff88e88 61919-291 HUMAN PRESCRIPTION DRUG PREDNISOLONE PREDNISOLONE SOLUTION ORAL 20140101 ANDA ANDA040401 DIRECT RX PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61919-293_ac351f18-37c0-494a-b4dc-12ae690853a8 61919-293 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20150101 ANDA ANDA040907 DIRECT RX HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 61919-295_26a02033-10ab-0c2c-e054-00144ff88e88 61919-295 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20140101 ANDA ANDA077955 Direct Rx AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 61919-296_3fdeac85-5fd8-04fa-e054-00144ff88e88 61919-296 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, COATED ORAL 20140101 ANDA ANDA077723 DIRECT RX HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-298_255eab95-a7ab-3a37-e054-00144ff8d46c 61919-298 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20151125 ANDA ANDA202433 DirectRX TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 61919-299_f10364fd-7b0a-457a-abc3-2fe77f49e6df 61919-299 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE TABLET, FILM COATED ORAL 20150101 ANDA ANDA065285 DirectRX DOXYCYCLINE 50 mg/1 E 20171231 61919-300_ad3968a1-6821-4889-9ed5-a4057eb3a65c 61919-300 HUMAN PRESCRIPTION DRUG SUMATRIPTAN sumatriptan succinate tablet TABLET ORAL 20150101 ANDA ANDA078327 DIRECT RX SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 61919-301_3218d48a-aa81-0105-e054-00144ff88e88 61919-301 HUMAN PRESCRIPTION DRUG MECLIZINE MECLIZINE TABLET ORAL 20160428 ANDA ANDA200294 DIRECT RX MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 61919-305_43cc254b-6634-63dd-e054-00144ff88e88 61919-305 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE CYCLOBENZAPRINE TABLET, FILM COATED ORAL 20161216 ANDA ANDA090478 DIRECT RX CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-306_3606fa63-73c6-2209-e054-00144ff8d46c 61919-306 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20140101 ANDA ANDA075743 DIRECT RX LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61919-308_70d7ab78-b648-42c5-898a-0e807cdaa0ad 61919-308 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140101 ANDA ANDA077912 DIRECT RX HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61919-309_269035f2-9ae4-4228-e054-00144ff8d46c 61919-309 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20150101 ANDA ANDA077912 DIRECT RX HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61919-311_261912cc-3ed9-5bf3-e054-00144ff8d46c 61919-311 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20140101 ANDA ANDA078296 Direct Rx LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 61919-313_3461e926-ecc8-6212-e054-00144ff8d46c 61919-313 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA090564 DIRECT RX METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 61919-316_375bfe83-c894-3ea7-e054-00144ff88e88 61919-316 HUMAN PRESCRIPTION DRUG PHENTERMINE HCL PHENTERMINE HCL CAPSULE ORAL 20160708 ANDA ANDA040886 DIRECT RX PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 61919-317_36078f36-96a2-73d1-e054-00144ff88e88 61919-317 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET ORAL 20140101 ANDA ANDA074644 DIRECT RX METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61919-319_4987b137-1637-058e-e054-00144ff88e88 61919-319 HUMAN PRESCRIPTION DRUG NIFEDIPINE NIFEDIPINE TABLET, EXTENDED RELEASE ORAL 20170227 ANDA ANDA203126 DIRECT RX NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 61919-320_2b3329d0-adc3-4f6a-a471-048550297e44 61919-320 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET ORAL 20140101 ANDA ANDA078154 DIRECT RX LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-321_26a00694-0e8a-2287-e054-00144ff8d46c 61919-321 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20150101 ANDA ANDA040362 DirectRX PREDNISONE 5 mg/1 E 20171231 61919-322_270abf14-bcff-3580-e054-00144ff88e88 61919-322 HUMAN PRESCRIPTION DRUG PAROXETINE PAROXETINE TABLET, FILM COATED ORAL 20140101 ANDA ANDA075356 DIRECT RX PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-323_2b19cbaf-7af0-45a7-bfff-5cdc41ba8dfb 61919-323 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20150101 ANDA ANDA091113 DirectRX ESZOPICLONE 1 mg/1 CIV E 20171231 61919-324_3fded22f-1c6c-0861-e054-00144ff88e88 61919-324 HUMAN PRESCRIPTION DRUG DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA085223 DIRECT RX DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 61919-325_9f09749c-da04-464b-9964-060e7addc383 61919-325 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE, LIQUID FILLED ORAL 20150101 ANDA ANDA040682 DirectRX BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 61919-326_3fdee281-9362-0c14-e054-00144ff88e88 61919-326 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20140101 ANDA ANDA080356 DIRECT RX PREDNISONE 20 mg/1 E 20171231 61919-328_b3b4becf-9dba-450d-84a5-7be6b501e903 61919-328 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET ORAL 20150101 ANDA ANDA088628 Direct RX ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 61919-329_a8eb8a82-e2ef-4b86-9bd1-e99bd945c0ed 61919-329 HUMAN PRESCRIPTION DRUG CLOBETASOL PROPIONATE clobetasol propionate gel GEL TOPICAL 20150101 ANDA ANDA075027 Direct RX CLOBETASOL PROPIONATE .05 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61919-330_260054b1-f949-3e57-e054-00144ff88e88 61919-330 HUMAN PRESCRIPTION DRUG GLYBURIDE GLYBURIDE TABLET ORAL 20151203 ANDA ANDA090937 DirectRX GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 61919-332_1c21217f-54e6-4511-8ed5-17f0c0970585 61919-332 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20150101 ANDA ANDA202554 DirectRX LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61919-333_2bd09078-6204-5b2b-e054-00144ff8d46c 61919-333 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20160212 ANDA ANDA077253 Direct RX FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 61919-335_35e360f7-dc3d-5dd9-e054-00144ff88e88 61919-335 HUMAN PRESCRIPTION DRUG Tramadol Acetaminophen Tramadol Acetaminophen TABLET ORAL 20150101 ANDA ANDA090460 Direct Rx ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV E 20171231 61919-337_3e0eabed-452d-123c-e054-00144ff8d46c 61919-337 HUMAN PRESCRIPTION DRUG MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE ORAL 20160906 ANDA ANDA065062 DIRECT RX MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 61919-338_25dc3437-0043-74a1-e054-00144ff88e88 61919-338 HUMAN PRESCRIPTION DRUG TRIAMTERENE AND HYDROCHLOROTHIAZIDE TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET ORAL 20151201 ANDA ANDA071251 DirectRX TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 61919-339_5b3542a3-7e9f-a5ee-e053-2991aa0aa1c3 61919-339 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET, FILM COATED ORAL 20171010 ANDA ANDA078542 DIRECT RX RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 61919-340_5d50b3b3-cf1f-1d10-e053-2a91aa0a6de6 61919-340 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20171106 ANDA ANDA076001 DIRECT RX FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61919-341_3e6c2449-48b0-4cc4-81c3-2abd8dfabb59 61919-341 HUMAN PRESCRIPTION DRUG WARFARIN SODIUM WARFARIN SODIUM TABLET ORAL 20150101 ANDA ANDA040616 DirectRX WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 61919-342_50591b8b-db73-4dd4-bc53-1af02a02c857 61919-342 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20150101 ANDA ANDA083677 DirectRX PREDNISONE 20 mg/1 E 20171231 61919-342_5f6c5083-bdcf-44a6-83de-b12263909b12 61919-342 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20150101 ANDA ANDA083677 DIRECT RX PREDNISONE 20 mg/1 E 20171231 61919-343_5cd96e45-e028-3c9a-e053-2a91aa0a807e 61919-343 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION TOPICAL 20171031 ANDA ANDA202027 DIRECT RX DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61919-344_b63acc57-8efe-4413-b4c0-ff35a197c733 61919-344 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN CAPSULE, EXTENDED RELEASE ORAL 20150101 ANDA ANDA201807 Direct RX INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-346_3fdeec87-de80-0cd5-e054-00144ff88e88 61919-346 HUMAN PRESCRIPTION DRUG METAXALONE METAXALONE TABLET ORAL 20140101 NDA NDA013217 DIRECT RX METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 61919-348_5cd9a309-394b-108a-e053-2991aa0a7434 61919-348 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171031 NDA NDA021774 DIRECT RX ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 61919-349_27f6bec9-90aa-4c4c-e054-00144ff8d46c 61919-349 HUMAN PRESCRIPTION DRUG ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20151221 ANDA ANDA079057 DirectRX ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 61919-350_2e319a08-901e-40a9-e054-00144ff88e88 61919-350 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET ORAL 20160316 ANDA ANDA077662 DIRECT RX GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-352_480add5c-5f91-69d8-e054-00144ff88e88 61919-352 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20170208 ANDA ANDA201507 DIRECT RX HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 61919-354_33209430-6d78-1c13-e054-00144ff8d46c 61919-354 HUMAN PRESCRIPTION DRUG ROBAXIN METHOCARBAMOL TABLET, FILM COATED ORAL 20160203 ANDA ANDA200958 DIRECT RX METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-355_30635424-e6bd-1bff-e054-00144ff88e88 61919-355 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN CAPSULE ORAL 20160411 ANDA ANDA064076 DIRECTRX AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-355_35651b85-b736-7299-e054-00144ff8d46c 61919-355 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN CAPSULE ORAL 20160615 ANDA ANDA064076 DIRECT RX AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-356_76f5f437-1d95-4073-a4bd-23e4cbb3b9ac 61919-356 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20150101 ANDA ANDA075994 DirectRX LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61919-357_3fdec28b-6a65-0212-e054-00144ff88e88 61919-357 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140101 ANDA ANDA088496 Direct Rx HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 61919-358_33ad783f-b634-6a70-e054-00144ff8d46c 61919-358 HUMAN PRESCRIPTION DRUG KEFLEX CEPHALEXIN CAPSULE ORAL 20160502 ANDA ANDA065253 DIRECT RX CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61919-359_33c4a32f-15f5-3d0c-e054-00144ff88e88 61919-359 HUMAN PRESCRIPTION DRUG LEVAQUIN LEVOFLOXACIN TABLET ORAL 20160526 ANDA ANDA200839 DIRECT RX LEVOFLOXACIN 250 mg/1 E 20171231 61919-360_494d5207-1c02-72fd-e054-00144ff88e88 61919-360 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20160302 ANDA ANDA204197 DIRECT RX CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61919-361_4171a441-871a-5977-e054-00144ff88e88 61919-361 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN TABLET ORAL 20161116 ANDA ANDA076639 DIRECT RX CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 61919-362_402ed3b6-2a06-411f-e054-00144ff8d46c 61919-362 HUMAN PRESCRIPTION DRUG AZITHROMYCIN DIHYDRATE AZITHROMYCIN DIHYDRATE TABLET, FILM COATED ORAL 20140101 ANDA ANDA065507 DIRECT RX AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 61919-364_402f2742-d003-44bf-e054-00144ff8d46c 61919-364 HUMAN PRESCRIPTION DRUG HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20140101 ANDA ANDA088799 DIRECT RX HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61919-365_3464d821-c5c9-0952-e054-00144ff8d46c 61919-365 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20140101 ANDA ANDA040584 DIRECT RX PREDNISONE 5 mg/1 E 20171231 61919-366_bf7babad-0862-47a7-b8d5-b9ff780f10f7 61919-366 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin tablet, film coated TABLET ORAL 20150101 ANDA ANDA065256 Direct RX AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-367_aec04fa3-6bdb-4c8a-be28-b47cae51a286 61919-367 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20150101 ANDA ANDA071135 Direct Rx DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61919-370_26921ec2-018d-331e-e054-00144ff88e88 61919-370 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR TABLET ORAL 20140101 ANDA ANDA075382 Direct RX ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 61919-371_402f0f1e-87ed-74bf-e054-00144ff88e88 61919-371 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN TABLET ORAL 20140101 ANDA ANDA076639 Direct Rx CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 61919-372_4984b255-e03c-0f7b-e054-00144ff88e88 61919-372 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20170227 ANDA ANDA075483 DIRECT RX ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 61919-373_40414e3c-f866-0d99-e054-00144ff8d46c 61919-373 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140101 ANDA ANDA080292 Direct Rx PREDNISONE 5 mg/1 E 20171231 61919-377_5dc82a54-d435-2b58-e053-2991aa0a7031 61919-377 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20171101 ANDA ANDA077749 DIRECT RX DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 61919-378_2615ee96-7a3e-5cde-e054-00144ff8d46c 61919-378 HUMAN PRESCRIPTION DRUG GLYBURIDE GLYBURIDE TABLET ORAL 20151203 ANDA ANDA090937 DirectRX GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 61919-379_5dc82a54-d423-2b58-e053-2991aa0a7031 61919-379 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET ORAL 20171101 ANDA ANDA078491 DIRECT RX ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 61919-380_5dc82a54-d413-2b58-e053-2991aa0a7031 61919-380 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20171101 ANDA ANDA076658 Direct Rx FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 61919-382_47d2d292-7798-4416-834e-4c35983ace85 61919-382 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN POWDER, FOR SUSPENSION ORAL 20140101 ANDA ANDA065246 DIRECT RX AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 61919-383_357e043c-84aa-4247-b4f1-aff354266fbf 61919-383 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20150101 ANDA ANDA065223 DirectRX AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 61919-385_40414e3c-f875-0d99-e054-00144ff8d46c 61919-385 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET ORAL 20140101 ANDA ANDA079067 DIRECT RX METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 61919-388_2d78bd54-2edb-37a7-e054-00144ff88e88 61919-388 HUMAN PRESCRIPTION DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET ORAL 20160307 ANDA ANDA074661 DIRECT RX NAPROXEN SODIUM 220 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-389_35e38d4b-d0eb-43f9-e054-00144ff8d46c 61919-389 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20150101 ANDA ANDA078216 Direct Rx CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-390_35e38d4b-d0fe-43f9-e054-00144ff8d46c 61919-390 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20150101 ANDA ANDA078216 Direct Rx CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-396_3944cd91-7185-5ad0-e054-00144ff88e88 61919-396 HUMAN PRESCRIPTION DRUG PHENERGAN PROMWTHAZINE TABLET ORAL 20160804 ANDA ANDA040863 DIRECT RX PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 61919-397_26f24ac8-5c83-34f9-e054-00144ff88e88 61919-397 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA090564 Direct Rx METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 61919-397_37104e00-8195-5018-e054-00144ff88e88 61919-397 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA090564 Direct Rx METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 61919-399_a7a5fe54-5874-40e6-815e-174b57bb6452 61919-399 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN POWDER, FOR SUSPENSION ORAL 20140101 ANDA ANDA065334 DIRECT RX AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-401_1a440784-8037-4a8a-9f4a-cd5ec463e3bf 61919-401 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN POWDER, FOR SUSPENSION ORAL 20140101 ANDA ANDA065334 DIRECT RX AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-402_2badb011-7f09-440c-9aea-59ad6004cfe4 61919-402 HUMAN OTC DRUG CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE TABLET ORAL 20140101 OTC MONOGRAPH FINAL part341 DIRECT RX CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 61919-403_26053cc7-eb22-6f0a-e054-00144ff88e88 61919-403 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20151202 NDA AUTHORIZED GENERIC NDA021210 DirectRX LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 61919-404_40414e3c-f866-0d99-e054-00144ff8d46c 61919-404 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20140101 ANDA ANDA088832 Direct Rx PREDNISONE 10 mg/1 E 20171231 61919-406_5d2e896b-76d8-5752-e053-2a91aa0a8345 61919-406 HUMAN PRESCRIPTION DRUG VENLAFAXINE VENLAFAXINE TABLET ORAL 20171031 ANDA ANDA202036 DIRECT RX VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61919-407_ead3ddea-22e9-419e-bff2-99b13561e0e7 61919-407 HUMAN PRESCRIPTION DRUG MUPIROCIN 2% MUPIROCIN OINTMENT TOPICAL 20150101 ANDA ANDA090480 DirectRX MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 61919-408_34b663e0-e40d-366f-e054-00144ff8d46c 61919-408 HUMAN PRESCRIPTION DRUG IMITREX SUMATRIPTAN TABLET ORAL 20160606 ANDA ANDA078327 DIRECT RX SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 61919-410_37ad16fe-df8f-0f36-e054-00144ff88e88 61919-410 HUMAN PRESCRIPTION DRUG KEFLEX CEPHALEXIN CAPSULE ORAL 20160714 ANDA ANDA065248 DIRECT RX CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61919-416_3fb439b4-486d-092a-e054-00144ff8d46c 61919-416 HUMAN PRESCRIPTION DRUG SERTRALINE SERTRALINE TABLET ORAL 20140101 ANDA ANDA077397 DIRECT RX SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-418_26177ce8-8437-22c1-e054-00144ff8d46c 61919-418 HUMAN PRESCRIPTION DRUG GLYBURIDE AND METFORMIN HYDROCHLORIDE GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20151203 ANDA ANDA077870 DirectRX GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 61919-419_40428526-bb95-4368-e054-00144ff8d46c 61919-419 HUMAN PRESCRIPTION DRUG FLUCONAZOLE FLUCONAZOLE TABLET ORAL 20140101 ANDA ANDA076077 DIRECT RX FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 61919-420_414766e0-5756-5af3-e054-00144ff88e88 61919-420 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET ORAL 20140101 OTC MONOGRAPH FINAL part343 DIRECT RX ASPIRIN 81 mg/1 E 20171231 61919-421_161d9e40-29f8-484e-bc7c-99c43d83cea1 61919-421 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN SOLUTION/ DROPS TOPICAL 20140101 ANDA ANDA077689 Direct Rx CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 61919-421_4a3a5a4a-623f-13ed-e054-00144ff8d46c 61919-421 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN ciprofloxacin hydrochloride solution SOLUTION/ DROPS TOPICAL 20140101 ANDA ANDA077689 DIRECT RX CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 61919-422_441a46f0-ecc8-4448-e054-00144ff88e88 61919-422 HUMAN PRESCRIPTION DRUG DULOXETINE DULOXETINE CAPSULE, DELAYED RELEASE PELLETS ORAL 20161220 ANDA ANDA203088 DIRECT RX DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-423_511b01e7-5d76-42dd-8714-848110fde6b4 61919-423 HUMAN PRESCRIPTION DRUG LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA073192 DIRECT RX LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] E 20171231 61919-424_40433390-cf82-4638-e054-00144ff88e88 61919-424 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN CAPSULE ORAL 20140101 ANDA ANDA061926 DIRECT RX AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-428_3fb3356a-cfac-6897-e054-00144ff8d46c 61919-428 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TARTRATE TABLET ORAL 20140101 ANDA ANDA074644 DIRECT RX METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61919-429_4445548f-d11d-3c1b-e054-00144ff8d46c 61919-429 HUMAN PRESCRIPTION DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET ORAL 20161222 ANDA ANDA077829 DIRECT RX CETIRIZINE HYDROCHLORIDE 10 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 61919-431_a7ed685b-020b-4f45-b73d-2814dc29dd69 61919-431 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20140101 ANDA ANDA078155 DIRECT RX SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 61919-432_355379a5-027c-3c74-e054-00144ff88e88 61919-432 HUMAN PRESCRIPTION DRUG PERCOCET OXYCODONE/APAP TABLET ORAL 20160615 ANDA ANDA202677 DIRECT RX ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 61919-433_272f6760-202b-0acf-e054-00144ff88e88 61919-433 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE TABLET, COATED ORAL 20151217 ANDA ANDA065095 DirectRX DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 61919-434_3fc56e9b-52cb-3c01-e054-00144ff8d46c 61919-434 HUMAN PRESCRIPTION DRUG MELOXICAM MELOXICAM TABLET ORAL 20140101 ANDA ANDA077927 Direct Rx MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-435_bfcaa834-9f8d-41ed-aa2d-7059b14cd9da 61919-435 HUMAN PRESCRIPTION DRUG NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE ORAL 20150101 ANDA ANDA074132 Direct Rx NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61919-438_404307ae-aa69-6854-e054-00144ff8d46c 61919-438 HUMAN PRESCRIPTION DRUG TEMAZEPAM TEMAZEPAM CAPSULE ORAL 20140101 ANDA ANDA071620 Direct Rx TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 61919-441_346571b4-f3df-6d58-e054-00144ff88e88 61919-441 HUMAN PRESCRIPTION DRUG CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA065061 DIRECT RX CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 61919-442_40431725-fb28-6a62-e054-00144ff8d46c 61919-442 HUMAN PRESCRIPTION DRUG FUROSEMIDE FUROSEMIDE TABLET ORAL 20140101 ANDA ANDA076796 DIRECT RX FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 61919-443_40435ff0-5f38-4874-e054-00144ff88e88 61919-443 HUMAN PRESCRIPTION DRUG LIDOCAINE AND PRILOCAINE LIDOCAINE AND PRILOCAINE CREAM TOPICAL 20140101 NDA NDA019941 DIRECT RX LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 61919-445_407aa57c-475b-6037-e054-00144ff8d46c 61919-445 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140101 NDA NDA018279 DIRECT RX POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 61919-446_34654cec-f0ba-1d9a-e054-00144ff8d46c 61919-446 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20140101 ANDA ANDA078155 Direct Rx SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 61919-448_254e279f-c853-1197-e054-00144ff8d46c 61919-448 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20151124 ANDA ANDA078181 DirectRX GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 61919-450_4833deea-a19e-63b1-e054-00144ff8d46c 61919-450 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE EXTENDED RELEASE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20170210 ANDA ANDA201991 DIRECT RX METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 61919-450_d17f42c5-d4e6-4f37-9153-f37f40f7d225 61919-450 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE E/R METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20150101 ANDA ANDA201991 DirectRX METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 61919-451_25a51e2c-3fb3-4ed6-ab17-e3c08140f17b 61919-451 HUMAN PRESCRIPTION DRUG TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE TABLET ORAL 20150101 ANDA ANDA077137 DirectRX TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] E 20171231 61919-455_5d2e896b-76ee-5752-e053-2a91aa0a8345 61919-455 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET, FILM COATED ORAL 20140101 ANDA ANDA078542 DIRECT RX RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 61919-457_3fb439b4-486d-092a-e054-00144ff8d46c 61919-457 HUMAN PRESCRIPTION DRUG SERTRALINE SERTRALINE TABLET ORAL 20140101 ANDA ANDA077397 DIRECT RX SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-459_f012ed63-10fa-4205-90a5-fedb7c6be942 61919-459 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140101 OTC MONOGRAPH NOT FINAL part334 DIRECT RX DOCUSATE SODIUM 100 mg/1 E 20171231 61919-460_407ab00a-16af-12ef-e054-00144ff88e88 61919-460 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20140101 ANDA ANDA078414 DIRECT RX AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 61919-461_25fe6b18-e409-4b17-e054-00144ff8d46c 61919-461 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET ORAL 20151203 ANDA ANDA090467 DirectRX LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 61919-464_2690242c-d219-5487-e054-00144ff88e88 61919-464 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20140101 ANDA ANDA077851 DIRECT RX ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 61919-465_34659398-1c42-27dd-e054-00144ff8d46c 61919-465 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20140101 ANDA ANDA077851 DIRECT RX ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 61919-468_45fd0a74-412d-44bb-8e72-f8a65b2ce974 61919-468 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150101 ANDA ANDA076201 Direct RX DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-469_3fc56e9b-52cb-3c01-e054-00144ff8d46c 61919-469 HUMAN PRESCRIPTION DRUG MELOXICAM MELOXICAM TABLET ORAL 20140101 ANDA ANDA077927 Direct Rx MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-472_54153740-88fd-49f9-857f-1ee544adb9ab 61919-472 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE ACETAMINOPHEN AND CODEINE TABLET ORAL 20140101 ANDA ANDA089828 DIRECT RX CODEINE PHOSPHATE; ACETAMINOPHEN 60; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-474_35e38d4b-d111-43f9-e054-00144ff8d46c 61919-474 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20150101 ANDA ANDA091605 Direct Rx DOXYCYCLINE 100 mg/1 E 20171231 61919-476_494ce357-e391-65e8-e054-00144ff88e88 61919-476 HUMAN PRESCRIPTION DRUG GLIPIZIDE GLIPIZIDE TABLET ORAL 20170224 ANDA ANDA074550 DIRECT RX GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 61919-478_407aeb90-fada-71bf-e054-00144ff8d46c 61919-478 HUMAN PRESCRIPTION DRUG CHLORZOXAZONE CHLORZOXAZONE TABLET ORAL 20140101 ANDA ANDA089859 DIRECT RX CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-480_407b5fd6-2337-2ba7-e054-00144ff88e88 61919-480 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET ORAL 20140101 ANDA ANDA077032 DIRECT RX CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-481_407bc06c-5c0a-433a-e054-00144ff88e88 61919-481 HUMAN PRESCRIPTION DRUG CLONAZEPAM CLONAZEPAM TABLET ORAL 20140101 ANDA ANDA074869 DIRECT RX CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 61919-482_3710dd6f-4689-288b-e054-00144ff8d46c 61919-482 HUMAN PRESCRIPTION DRUG DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140101 ANDA ANDA203088 DIRECT RX DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-483_407bd84d-8ad0-46bf-e054-00144ff88e88 61919-483 HUMAN PRESCRIPTION DRUG DULOXETINE DULOXETINE CAPSULE, DELAYED RELEASE ORAL 20140101 ANDA ANDA090745 DIRECT RX DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-487_8f04029c-263e-4334-b501-76525d049a31 61919-487 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN CAPSULE ORAL 20150101 NDA NDA018851 DirectRX INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-488_5c370417-eff1-7280-e053-2a91aa0a1446 61919-488 HUMAN PRESCRIPTION DRUG Propranolol hcl ER Propranolol hcl ER CAPSULE, EXTENDED RELEASE ORAL 20171023 NDA AUTHORIZED GENERIC NDA018553 Direct Rx PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61919-489_5c370417-eff1-7280-e053-2a91aa0a1446 61919-489 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE ER PROPRANOLOL HYDROCHLORIDE ER CAPSULE, EXTENDED RELEASE ORAL 20171027 NDA AUTHORIZED GENERIC NDA018553 Direct Rx PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61919-490_26010f0c-4cce-5d74-e054-00144ff88e88 61919-490 HUMAN PRESCRIPTION DRUG FLUOXETINE HCL FLUOXETINE CAPSULE ORAL 20150101 ANDA ANDA076990 DirectRX FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-492_7d9af18b-1edc-4f6b-a4aa-5cca7652b600 61919-492 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20150101 ANDA ANDA077242 Direct Rx GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-494_2690b62f-9629-6bab-e054-00144ff8d46c 61919-494 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET ORAL 20140101 ANDA ANDA040736 DIRECT RX HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 61919-495_1c61e6ff-f283-44c5-baad-47fe56b855af 61919-495 HUMAN PRESCRIPTION DRUG VENLAFAXINE VENLAFAXINE TABLET ORAL 20150101 ANDA ANDA078627 DirectRX VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-500_26919045-0865-0efd-e054-00144ff8d46c 61919-500 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140101 ANDA ANDA091103 Direct Rx ESZOPICLONE 3 mg/1 CIV E 20171231 61919-502_6db26b35-5c99-412a-b880-37e5b713a9da 61919-502 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20150101 ANDA ANDA091103 DIRECT RX ESZOPICLONE 1 mg/1 CIV E 20171231 61919-503_407c3608-0e8e-2f97-e054-00144ff8d46c 61919-503 HUMAN PRESCRIPTION DRUG PREGABALIN PREGABALIN CAPSULE ORAL 20140101 NDA NDA021446 DIRECT RX PREGABALIN 50 mg/1 E 20171231 61919-504_349d2d18-4b76-4fd2-e054-00144ff88e88 61919-504 HUMAN PRESCRIPTION DRUG LYRICA LYRICA CAPSULE ORAL 20140101 NDA NDA021446 Direct RX PREGABALIN 75 mg/1 E 20171231 61919-505_3f9ee806-f437-3cec-e054-00144ff88e88 61919-505 HUMAN PRESCRIPTION DRUG LYRICA LYRICA CAPSULE ORAL 20150101 NDA NDA021446 DirectRX PREGABALIN 100 mg/1 CV E 20171231 61919-506_4418f091-fc31-317a-e054-00144ff8d46c 61919-506 HUMAN PRESCRIPTION DRUG LYRICA Pregabalin CAPSULE ORAL 20140101 NDA NDA021446 DIRECT RX PREGABALIN 150 mg/1 CV E 20171231 61919-509_3fa00edd-12ba-516d-e054-00144ff8d46c 61919-509 HUMAN PRESCRIPTION DRUG NEXIUM esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20140101 ANDA ANDA021957 DIRECT RX ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-510_48fc5196-287b-1c57-e054-00144ff8d46c 61919-510 HUMAN PRESCRIPTION DRUG NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE ORAL 20170220 ANDA ANDA073556 DIRECT RX NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 61919-512_3fa07f23-1d7c-0425-e054-00144ff8d46c 61919-512 HUMAN PRESCRIPTION DRUG PAROXETINE PAROXETINE TABLET, FILM COATED ORAL 20150101 ANDA ANDA075356 DirectRX PAROXETINE HYDROCHLORIDE ANHYDROUS 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-513_2cfe30fc-9c47-4efd-e054-00144ff8d46c 61919-513 HUMAN PRESCRIPTION DRUG PAROXETINE PAROXETINE TABLET, FILM COATED ORAL 20160229 ANDA ANDA077584 DIRECT RX PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-514_2cedcc9d-ab84-3b5a-e054-00144ff8d46c 61919-514 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20151215 ANDA ANDA091113 DIRECT RX ESZOPICLONE 3 mg/1 CIV E 20171231 61919-518_c9375f96-4526-4f72-ad50-be271e274101 61919-518 HUMAN OTC DRUG DOCUSATE SODIUM AND SENNA DOCUSATE SODIUM AND SENNA TABLET, FILM COATED ORAL 20140101 OTC MONOGRAPH NOT FINAL part334 DIRECT RX DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 E 20171231 61919-519_0deff0d8-28aa-4a3a-9724-d74eb789020b 61919-519 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, FILM COATED ORAL 20150101 ANDA ANDA202152 Direct RX QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 61919-520_49248d7b-06b9-6e90-e054-00144ff88e88 61919-520 HUMAN PRESCRIPTION DRUG LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE SOLUTION ORAL; TOPICAL 20170222 ANDA ANDA040014 DIRECT RX LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 61919-521_429b7531-a24b-631f-e054-00144ff88e88 61919-521 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20161201 ANDA ANDA065096 DIRECT RX AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 61919-522_510958a1-6855-4684-ad7b-0ae85e3d819a 61919-522 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN CAPSULE ORAL 20150101 ANDA ANDA062713 DirectRX CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 61919-527_ec8f5298-4530-44fe-9059-89b97cba1712 61919-527 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, FILM COATED ORAL 20140101 ANDA ANDA078616 DIRECT RX ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] E 20171231 61919-528_05a546cc-4ed6-4466-a288-63ee2e1193d4 61919-528 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, FILM COATED ORAL 20140101 ANDA ANDA078616 DIRECT RX ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] E 20171231 61919-530_27f7488a-a069-45c7-e054-00144ff88e88 61919-530 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20150101 ANDA ANDA203834 Direct Rx ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 61919-531_f271d891-a272-4a29-9b10-351075f6c190 61919-531 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20150101 ANDA ANDA090548 DirectRX ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 61919-533_3fa07d63-3495-0486-e054-00144ff8d46c 61919-533 HUMAN PRESCRIPTION DRUG CARVEDILOL CARVEDILOL TABLET, FILM COATED ORAL 20140101 ANDA ANDA078384 DIRECT RX CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 61919-535_349d936a-7762-6a98-e054-00144ff8d46c 61919-535 HUMAN PRESCRIPTION DRUG VENLAFAXINE VENLAFAXINE TABLET ORAL 20140101 ANDA ANDA078554 Direct Rx VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-536_26505705-fdcd-6f57-e054-00144ff88e88 61919-536 HUMAN PRESCRIPTION DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20151203 ANDA ANDA076447 DirectRX FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 61919-538_203854ab-0337-4d2b-863f-12cdd530c4f3 61919-538 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20140101 ANDA ANDA077829 DIRECT RX CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 61919-540_339af810-2a33-0804-e054-00144ff8d46c 61919-540 HUMAN PRESCRIPTION DRUG LIPITOR ATORVASTATIN TABLET ORAL 20160129 ANDA ANDA091650 DIRECT RX ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 61919-542_267d6042-f4cc-4d5c-e054-00144ff8d46c 61919-542 HUMAN PRESCRIPTION DRUG GAVILAX GAVILAX POWDER, FOR SOLUTION ORAL 20150101 ANDA ANDA091077 DirectRX POLYETHYLENE GLYCOL 3350 17 g/17g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 61919-543_9b0a06e7-09fc-4e32-a538-b2ff433d88dd 61919-543 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20150101 ANDA ANDA091650 DirectRX ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 61919-544_2a7c735b-dfa7-4165-b2ad-d15d5650d6e9 61919-544 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA090478 DIRECT RX CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-545_25d89f8a-6e81-3ea4-e054-00144ff8d46c 61919-545 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20140101 ANDA ANDA090469 DIRECT RX ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 61919-546_27faaf95-710c-4ba1-e054-00144ff88e88 61919-546 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20151228 ANDA ANDA076939 DirectRX PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 61919-547_357f2d56-54bb-0092-e054-00144ff88e88 61919-547 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20140101 ANDA ANDA075991 DIRECT RX LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 61919-555_330a082d-57b3-2bf5-e054-00144ff88e88 61919-555 HUMAN PRESCRIPTION DRUG ZITHROMAX AZITHROMYCIN TABLET, FILM COATED ORAL 20160302 ANDA ANDA065404 DIRECT RX AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 61919-556_40f9338f-419e-19a8-e054-00144ff8d46c 61919-556 HUMAN PRESCRIPTION DRUG PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA075735 DIRECT RX PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 50; .5 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV E 20171231 61919-560_3f4e78ca-10e1-0b9a-e054-00144ff88e88 61919-560 HUMAN PRESCRIPTION DRUG MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA065470 Direct Rx MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 61919-561_3b74bdb0-c69d-09f8-e054-00144ff88e88 61919-561 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20160822 ANDA ANDA202554 DIRECT RX LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61919-563_4193f1e3-7042-5187-e054-00144ff88e88 61919-563 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET ORAL 20160830 ANDA ANDA202764 DIRECT RX GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-565_2ebdb67e-d585-0f7b-e054-00144ff8d46c 61919-565 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20160323 ANDA ANDA078539 DIRECT RX ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 61919-566_4418b335-8108-1395-e054-00144ff88e88 61919-566 HUMAN PRESCRIPTION DRUG FLECTOR FLECTOR PATCH TOPICAL 20140101 NDA NDA021234 DIRECT RX DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-567_3f616c80-b8cf-320b-e054-00144ff88e88 61919-567 HUMAN PRESCRIPTION DRUG DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA070791 DIRECT RX DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61919-569_33af9350-95f4-384e-e054-00144ff88e88 61919-569 HUMAN PRESCRIPTION DRUG TRILEPTAL OXCARBAZEPINE TABLET ORAL 20160525 ANDA ANDA077802 DIRECT RX OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-572_3f4e7281-778f-5245-e054-00144ff8d46c 61919-572 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET, FILM COATED ORAL 20140101 ANDA ANDA078040 DIRECT RX RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 61919-574_9a4e1ffa-e9e7-4d9c-aa95-70697189a77f 61919-574 HUMAN PRESCRIPTION DRUG ETODOLAC ETODOLAC TABLET ORAL 20140101 ANDA ANDA075009 DIRECT RX ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-575_27f60ba8-a336-33b2-e054-00144ff8d46c 61919-575 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE ORAL 20151222 ANDA ANDA090066 DirectRX DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-576_3f60ae56-c4e3-1e88-e054-00144ff8d46c 61919-576 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET ORAL 20140101 ANDA ANDA074112 DIRECT RX ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61919-579_3f50c636-9fbc-57e6-e054-00144ff88e88 61919-579 HUMAN PRESCRIPTION DRUG BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA075022 Direct Rx BUSPIRONE HYDROCHLORIDE 15 mg/1 E 20171231 61919-580_3f4fd7ea-f3f9-1a3c-e054-00144ff8d46c 61919-580 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE CAPSULE ORAL 20140101 ANDA ANDA090510 DIRECT RX HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 61919-581_54b0cbf0-388c-6928-e054-00144ff8d46c 61919-581 HUMAN PRESCRIPTION DRUG ATENOLOL ATENOLOL TABLET ORAL 20170719 ANDA ANDA076900 DIRECT RX ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61919-583_584cc232-9a02-440d-9c4d-6e529f301f18 61919-583 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE ORAL 20150101 NDA NDA022370 Direct Rx TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-584_24f63275-a273-4bc9-9e15-e915c8ac9de5 61919-584 HUMAN PRESCRIPTION DRUG LORAZEPAM LORAZEPAM TABLET ORAL 20140101 ANDA ANDA071404 DIRECT RX LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 61919-585_3f50aafb-b5e9-4987-e054-00144ff88e88 61919-585 HUMAN PRESCRIPTION DRUG TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA071525 Direct Rx TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 61919-586_280ebc29-7026-67a3-e054-00144ff8d46c 61919-586 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20150101 ANDA ANDA091305 DirectRX NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-587_489833bd-1906-63b6-e054-00144ff8d46c 61919-587 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20170215 ANDA ANDA091113 DIRECT RX ESZOPICLONE 2 mg/1 CIV N 20181231 61919-589_6f42e268-f371-4121-8996-21eb04c17230 61919-589 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150101 ANDA ANDA077284 Direct Rx BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 61919-590_3f50f402-4781-6234-e054-00144ff88e88 61919-590 HUMAN PRESCRIPTION DRUG NORTRIPTYLINE HYDROCHLORIDE NORTRIPTYLINE HYDROCHLORIDE CAPSULE ORAL 20140101 ANDA ANDA073553 DIRECT RX NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 61919-591_4865755d-a929-4189-9cd7-e9b46bd011e8 61919-591 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20150101 ANDA ANDA077651 Direct Rx ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 61919-592_9441684a-4941-406f-a4a3-c9d996285bd3 61919-592 HUMAN PRESCRIPTION DRUG VOLTAREN VOLTAREN GEL TOPICAL 20150101 NDA NDA022122 DIRECT RX DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-595_25c3fe66-ab94-47e0-e054-00144ff8d46c 61919-595 HUMAN PRESCRIPTION DRUG MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE ORAL 20151130 ANDA ANDA065062 DirectRX MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 61919-599_3f513155-9822-68e0-e054-00144ff88e88 61919-599 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA077056 DIRECT RX PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 61919-600_73b417dc-de07-4e3b-8d6f-bb4cad514b91 61919-600 HUMAN PRESCRIPTION DRUG BUSPIRONE HYDROCHLORIDE BUSPIRONE HYDROCHLORIDE TABLET ORAL 20150101 ANDA ANDA078888 DirectRX BUSPIRONE HYDROCHLORIDE 10 mg/1 E 20171231 61919-602_3f51b242-63aa-15f3-e054-00144ff8d46c 61919-602 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20150101 ANDA ANDA077449 DirectRX FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 61919-603_349dc415-f44e-5eeb-e054-00144ff88e88 61919-603 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20150101 ANDA ANDA077449 DirectRX FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 61919-612_ac2efced-416f-48b1-8b21-09b0d37e7365 61919-612 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN TABLET ORAL 20150101 ANDA ANDA202677 Direct rx OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-614_3f518af5-8169-702d-e054-00144ff88e88 61919-614 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN TABLET ORAL 20140101 ANDA ANDA040777 DIRECT RX OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-615_2c8539a3-2558-56f2-e054-00144ff8d46c 61919-615 HUMAN PRESCRIPTION DRUG OXYCODONE APAP OXYCODONE APAP TABLET ORAL 20160223 ANDA ANDA040778 DIRECT RX OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 61919-621_281fdc28-fe10-3a47-e054-00144ff88e88 61919-621 HUMAN PRESCRIPTION DRUG IBU IBU TABLET ORAL 20151229 ANDA ANDA075682 DirectRX IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-621_3b3b9e31-6388-1260-e054-00144ff88e88 61919-621 HUMAN PRESCRIPTION DRUG IBU IBU TABLET ORAL 20160830 ANDA ANDA075682 DIRECT RX IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-623_429a7c98-cb02-4059-e054-00144ff88e88 61919-623 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN TABLET, FILM COATED ORAL 20161201 ANDA ANDA065256 DIRECT RX AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-627_280f0fbe-6127-1311-e054-00144ff88e88 61919-627 HUMAN PRESCRIPTION DRUG METHOCARBAMOL METHOCARBAMOL TABLET, FILM COATED ORAL 20150101 ANDA ANDA200958 DirectRX METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 61919-629_1d0d2582-07d9-4078-854a-891133eecf74 61919-629 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20150101 ANDA ANDA078989 DIRECT RX ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 61919-630_2c5d4ccc-5d68-0329-e054-00144ff88e88 61919-630 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20160218 ANDA ANDA040863 DIRECT RX PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 61919-630_2ebb4414-e3f5-3d8d-e054-00144ff88e88 61919-630 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20160302 ANDA ANDA040863 DIRECT RX PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 61919-634_09fbfdf9-5951-4633-8df8-40515546fb4b 61919-634 HUMAN PRESCRIPTION DRUG VALSARTAN AND HYDROCHLOROTHIAZIDE VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20150101 ANDA ANDA091519 DirectRX VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 61919-635_707ac533-98c6-4e90-8fd6-6e5cf7c11ff2 61919-635 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA090901 DIRECT RX PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 61919-636_49107644-9ba4-31b9-e054-00144ff88e88 61919-636 HUMAN PRESCRIPTION DRUG DULOXETINE DULOXETINE CAPSULE, DELAYED RELEASE ORAL 20170220 ANDA ANDA090745 DIRECT RX DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 61919-637_2562eeeb-c61d-0936-e054-00144ff88e88 61919-637 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED ORAL 20151125 ANDA ANDA065093 DirectRX AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 61919-638_3f4e6341-9fd7-079e-e054-00144ff88e88 61919-638 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE ORAL 20140101 ANDA ANDA040587 DIRECT RX BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 61919-639_99020322-1ae3-41de-824f-fb317bd8cf0b 61919-639 HUMAN PRESCRIPTION DRUG ALPRAZOLAM ALPRAZOLAM TABLET ORAL 20150101 ANDA ANDA090248 DirectRX ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61919-644_349e5c25-36f3-0398-e054-00144ff88e88 61919-644 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA078554 DIRECT RX VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-646_2bd1350a-5bb6-33c1-e054-00144ff88e88 61919-646 HUMAN PRESCRIPTION DRUG HYDROXYZINE HCL HYDROXYZINE HCL TABLET, FILM COATED ORAL 20160212 ANDA ANDA040804 DIRECT RX HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 61919-648_3f4d8406-4049-0912-e054-00144ff8d46c 61919-648 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20140101 ANDA ANDA078597 DIRECT RX DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 61919-651_4146ddc3-d208-5092-e054-00144ff88e88 61919-651 HUMAN OTC DRUG MUCINEX MUCINEX TABLET, EXTENDED RELEASE ORAL 20140101 NDA NDA021282 DIRECT RX GUAIFENESIN 600 mg/1 E 20171231 61919-652_73ec4639-e01c-40fb-bf71-511488b6b900 61919-652 HUMAN PRESCRIPTION DRUG ESCITALOPRAM ESCITALOPRAM TABLET, COATED ORAL 20150101 ANDA ANDA202389 DirectRX ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-654_879d96b3-0ad3-4927-9a4d-bc0908d2d387 61919-654 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR TABLET ORAL 20150101 ANDA ANDA203834 DirectRX ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 61919-657_3f4d6712-d471-5c1a-e054-00144ff88e88 61919-657 HUMAN PRESCRIPTION DRUG VENLAFAXINE VENLAFAXINE TABLET ORAL 20140101 ANDA ANDA078554 DIRECT RX VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-659_2b48c2dd-e62f-4f53-e054-00144ff88e88 61919-659 HUMAN PRESCRIPTION DRUG Oxycodone HCL Oxycodone HCL TABLET ORAL 20160208 ANDA ANDA090659 Direct RX OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 61919-659_2c6296ee-779b-419b-e054-00144ff8d46c 61919-659 HUMAN PRESCRIPTION DRUG OXYCODONE HCL OXYCODONE HCL TABLET ORAL 20160222 ANDA ANDA090659 DIRECT RX OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 61919-662_3f4d0dcd-36d9-49b8-e054-00144ff88e88 61919-662 HUMAN PRESCRIPTION DRUG NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS AURICULAR (OTIC) 20140101 ANDA ANDA064065 DIRECT RX HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 61919-663_25f1176d-5196-1a99-e054-00144ff8d46c 61919-663 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20151202 ANDA ANDA077903 DirectRX ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 61919-664_a53da87a-044b-432d-a1db-df3f9930db1f 61919-664 HUMAN PRESCRIPTION DRUG ATENOLOL ATENOLOL TABLET ORAL 20150101 ANDA ANDA074056 DirectRX ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61919-668_4445f9d9-4e8a-5d88-e054-00144ff8d46c 61919-668 HUMAN PRESCRIPTION DRUG NABUMETONE NABUMETONE TABLET, FILM COATED ORAL 20161222 ANDA ANDA078671 DIRECT RX NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-669_49253228-5aab-6ddc-e054-00144ff8d46c 61919-669 HUMAN PRESCRIPTION DRUG TRUVADA emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20170222 NDA NDA021752 DIRECT RX EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61919-670_349e17e5-6c16-0de6-e054-00144ff8d46c 61919-670 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20140101 NDA NDA006134 DIRECT RX METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-671_2c632617-2b8b-527c-e054-00144ff8d46c 61919-671 HUMAN PRESCRIPTION DRUG OXYCODONE HCL OXYCODONE HCL TABLET ORAL 20160222 ANDA ANDA203638 DIRECT RX OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 61919-676_2d90d16c-d99e-2199-e054-00144ff8d46c 61919-676 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20160303 ANDA ANDA075636 DIRECT RX LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 61919-679_410c3815-735c-0c78-e054-00144ff88e88 61919-679 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20160926 ANDA ANDA076343 DIRECT RX TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-685_349e9bd5-46fe-2c64-e054-00144ff8d46c 61919-685 HUMAN PRESCRIPTION DRUG LEVETIRACETAM LEVETIRACETAM TABLET, FILM COATED ORAL 20140101 ANDA ANDA078154 DIRECT RX LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-691_00ccf645-ff1d-45d0-83a5-69c69dc25456 61919-691 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20150101 ANDA ANDA079162 DirectRX TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-704_4ae2a680-29f3-40d3-8f35-c1decff7c0cb 61919-704 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET, FILM COATED ORAL 20150101 ANDA ANDA200839 DirectRX LEVOFLOXACIN 500 mg/1 E 20171231 61919-706_442d9e67-1c2d-73f8-e054-00144ff8d46c 61919-706 HUMAN PRESCRIPTION DRUG ISENTRESS ISENTRESS TABLET, FILM COATED ORAL 20161221 NDA NDA022145 DIRECT RX RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] E 20171231 61919-711_2f1d49ad-13cc-2a23-e054-00144ff88e88 61919-711 HUMAN PRESCRIPTION DRUG CHLORDIAZEPOXIDE CHLORDIAZEPOXIDE CAPSULE ORAL 20160304 ANDA ANDA085475 DIRECT RX CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 61919-718_3333bb84-a8c1-030e-e054-00144ff88e88 61919-718 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE TABLET ORAL 20150101 ANDA ANDA078895 DirectRX CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 61919-720_5f96a278-a1bb-4538-ad47-62c83233967e 61919-720 HUMAN PRESCRIPTION DRUG GLIMEPIRIDE GLIMEPIRIDE TABLET ORAL 20150101 ANDA ANDA077370 DirectRX GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 61919-725_f5b4d391-8b0c-4e7e-a8e8-e2855c1ed8ff 61919-725 HUMAN PRESCRIPTION DRUG GLIPIZIDE ER GLIPIZIDE ER TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150101 ANDA ANDA076467 DirectRX GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 61919-731_27fb491a-033f-60df-e054-00144ff88e88 61919-731 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20151228 ANDA ANDA076939 DirectRX PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 61919-735_3e0eabed-451b-123c-e054-00144ff8d46c 61919-735 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN TABLET ORAL 20160912 ANDA ANDA076639 DIRECT RX CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 61919-741_b89d05de-feee-4ce7-8edd-4dd1bdf8ee9e 61919-741 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20150101 ANDA ANDA200839 Direct Rx LEVOFLOXACIN 750 mg/1 E 20171231 61919-749_3f4d0dcd-36b8-49b8-e054-00144ff88e88 61919-749 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20140101 ANDA ANDA077636 DIRECT RX ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 61919-751_98b5e46e-efda-4d5a-957e-feac83c4c4a3 61919-751 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET ORAL 20150101 ANDA ANDA077903 DirectRX ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 61919-752_04ca583b-3540-4011-8817-352ea0dac42e 61919-752 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET ORAL 20150101 ANDA ANDA200294 DirectRX MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 61919-759_5d519235-600e-d619-e053-2a91aa0a1794 61919-759 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20171106 UNAPPROVED DRUG OTHER Direct Rx HYOSCYAMINE SULFATE .125 mg/1 N 20181231 61919-762_30777a3b-82a7-13bb-e054-00144ff88e88 61919-762 HUMAN PRESCRIPTION DRUG PHENAZOPYRIDINE PHENAZOPYRIDINE TABLET ORAL 20160414 UNAPPROVED DRUG OTHER DIRECT RX PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 E 20171231 61919-763_2bd5ca08-ac44-2b22-e054-00144ff8d46c 61919-763 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE, GELATIN COATED ORAL 20160215 ANDA ANDA202765 DIRECT RX BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 61919-766_b476f932-733b-4bde-bd42-afe553db3089 61919-766 HUMAN PRESCRIPTION DRUG SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET ORAL 20150101 ANDA ANDA076817 Direct Rx SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 61919-768_305fa9bc-9752-0aad-e054-00144ff88e88 61919-768 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20160401 ANDA ANDA040823 DIRECT RX CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV E 20171231 61919-773_4144b16e-5027-009d-e054-00144ff88e88 61919-773 HUMAN PRESCRIPTION DRUG OMEPRAZOLE DR OMEPRAZOLE DR CAPSULE, DELAYED RELEASE ORAL 20150101 ANDA ANDA076048 Direct Rx OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-775_35e39f10-24aa-5f4b-e054-00144ff88e88 61919-775 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20150101 ANDA ANDA077651 Direct Rx ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 61919-776_33d6f313-c764-5fbd-e054-00144ff8d46c 61919-776 HUMAN PRESCRIPTION DRUG ZITHROMAX AZITHROMYCIN TABLET ORAL 20160527 ANDA ANDA065405 DIRECT RX AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 61919-777_8c4ac1dc-3faa-4180-a9bf-913ccc1d283c 61919-777 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20150101 ANDA ANDA090170 Direct RX LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 61919-782_48f94245-3a9e-0b7c-e054-00144ff88e88 61919-782 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20170220 ANDA ANDA203245 DIRECT RX AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 61919-782_4910c9c2-d291-38c4-e054-00144ff8d46c 61919-782 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20170221 ANDA ANDA203245 DIRECT RX AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 61919-783_25f013ed-a992-6173-e054-00144ff8d46c 61919-783 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20151202 NDA NDA021210 DirectRX LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 61919-784_490cc21d-70a6-634b-e054-00144ff8d46c 61919-784 HUMAN PRESCRIPTION DRUG ETODOLAC ETODOLAC TABLET, FILM COATED ORAL 20170221 ANDA ANDA076004 DIRECT RX ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61919-785_35bc0f5f-d72c-0741-e054-00144ff8d46c 61919-785 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140101 ANDA ANDA090528 DIRECT RX HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 61919-788_494d657d-2178-284f-e054-00144ff8d46c 61919-788 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150101 ANDA ANDA079067 Direct Rx METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 61919-796_3783ce98-13c7-2004-e054-00144ff8d46c 61919-796 HUMAN PRESCRIPTION DRUG MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE CAPSULE ORAL 20151130 ANDA ANDA065062 DirectRX MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 61919-802_3f4c80af-5353-62ee-e054-00144ff8d46c 61919-802 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20140101 ANDA ANDA090170 DIRECT RX LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 61919-803_33d47ab6-9b85-58b0-e054-00144ff8d46c 61919-803 HUMAN PRESCRIPTION DRUG AMBIEN ZOLPIDEM TARTRATE TABLET ORAL 20160128 ANDA ANDA076410 DIRECT RX ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] E 20171231 61919-808_3f4c80af-533f-62ee-e054-00144ff8d46c 61919-808 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET ORAL 20140101 ANDA ANDA078955 DIRECT RX PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 61919-809_7cde8051-80fb-4f9e-b6f0-8780d19078e9 61919-809 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20150101 ANDA ANDA079163 DIRECT RX DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 61919-815_3f4c75c2-bdd2-3a45-e054-00144ff8d46c 61919-815 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE ORAL 20140101 ANDA ANDA040765 DIRECT RX PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 61919-817_35f40ddc-7232-35b7-e054-00144ff8d46c 61919-817 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20140101 ANDA ANDA090278 DIRECT RX TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-823_3f4c29dd-b2eb-3998-e054-00144ff88e88 61919-823 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20150101 ANDA ANDA090278 DirectRX TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-824_349e9bd5-4715-2c64-e054-00144ff8d46c 61919-824 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20140101 ANDA ANDA090278 DIRECT RX TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-824_5f93c061-23c0-46d9-89c8-6f333b4ca75c 61919-824 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20150101 ANDA ANDA090278 DIRECT RX TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-825_3f4b71aa-25e5-31fb-e054-00144ff8d46c 61919-825 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET ORAL 20140101 ANDA ANDA079153 DIRECT RX TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-826_3b3aae0f-4d1e-0244-e054-00144ff88e88 61919-826 HUMAN PRESCRIPTION DRUG SILDENAFIL SILDENAFIL TABLET, FILM COATED ORAL 20160829 ANDA ANDA203814 DIRECT RX SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 61919-826_84aeafa7-825f-4333-8161-8d107ff1b8e7 61919-826 HUMAN PRESCRIPTION DRUG SILDENAFIL SILDENAFIL TABLET, FILM COATED ORAL 20150101 ANDA ANDA203814 DirectRX SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 61919-829_30a7ab46-70c7-43fb-b643-b9fbf931b288 61919-829 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20150101 ANDA ANDA065243 Direct Rx CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 61919-831_04897f93-dd6f-4fff-b9d5-fc2928fb1cdf 61919-831 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET, FILM COATED ORAL 20150101 ANDA ANDA076635 DirectRX FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 61919-833_2b5cc18d-4342-40dd-e054-00144ff88e88 61919-833 HUMAN PRESCRIPTION DRUG RAMIPRIL RAMIPRIL CAPSULE, GELATIN COATED ORAL 20160113 ANDA ANDA091604 DIRECT RX RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61919-834_267916e4-c6ac-43b5-9d81-be20ff1b15d2 61919-834 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE MAGNESIUM D/R ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE ORAL 20150101 ANDA ANDA078279 DirectRX ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 61919-838_3f4b71aa-25d5-31fb-e054-00144ff8d46c 61919-838 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140101 ANDA ANDA075910 DIRECT RX DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-839_2f5ac7c6-a927-57df-e054-00144ff8d46c 61919-839 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160330 ANDA ANDA075350 DIRECT RX GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-839_2f5e3466-1711-1532-e054-00144ff8d46c 61919-839 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160330 ANDA ANDA075350 DIRECT RX GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-839_2fab077c-d3f4-5f8f-e054-00144ff8d46c 61919-839 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160330 ANDA ANDA075350 DIRECT RX GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-839_2faccf5e-9a82-3a3a-e054-00144ff8d46c 61919-839 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160330 ANDA ANDA075350 DIRECT RX GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-841_3f3e3636-9469-47bd-e054-00144ff88e88 61919-841 HUMAN PRESCRIPTION DRUG KETOCONAZOLE KETOCONAZOLE CREAM TOPICAL 20140101 ANDA ANDA076294 DIRECT RX KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 61919-843_25621e62-d329-6479-e054-00144ff88e88 61919-843 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN TABLET ORAL 20151125 ANDA ANDA202764 DirectRX GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-844_494d657d-219f-284f-e054-00144ff8d46c 61919-844 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20150101 ANDA ANDA203245 DirectRX AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 61919-848_40f9622e-27b4-6a5d-e054-00144ff88e88 61919-848 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140101 NDA NDA020699 DIRECT RX VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-859_33becde4-0b46-3615-e054-00144ff8d46c 61919-859 HUMAN PRESCRIPTION DRUG LEXAPRO ESCITALOPRAM TABLET ORAL 20160503 ANDA ANDA076765 DIRECT RX ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-866_6e78bccd-5bee-4ea3-a105-703da1cdc405 61919-866 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20150101 ANDA ANDA077058 DirectRX PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 61919-867_286c9e47-6665-42ae-8fb5-e7dfa1b4703d 61919-867 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150101 ANDA ANDA076361 Direct RX LEVOFLOXACIN 750 mg/1 E 20171231 61919-869_3fb5ac0a-344f-5b94-e054-00144ff88e88 61919-869 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20161025 ANDA ANDA078619 DIRECT RX FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-888_cdb61bfd-f6e7-454f-86d6-6049e0c2e95c 61919-888 HUMAN OTC DRUG Docusate Sodium Docusate Sodium TABLET ORAL 20150101 OTC MONOGRAPH NOT FINAL part334 Direct Rx DOCUSATE SODIUM 100 mg/1 E 20171231 61919-890_3f3ca7f1-5763-1ecc-e054-00144ff8d46c 61919-890 HUMAN PRESCRIPTION DRUG LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140101 ANDA ANDA202366 Direct RX LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 61919-891_55a64ae4-d52d-4151-85e9-23b34a3ec510 61919-891 HUMAN PRESCRIPTION DRUG LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED RELEASE ORAL 20140101 ANDA ANDA202366 DIRECT RX LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 61919-892_349ebc5f-3eed-15ba-e054-00144ff88e88 61919-892 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE ER TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA201384 DirectRX TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-893_3710bc3a-b9ee-61b1-e054-00144ff88e88 61919-893 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA201384 DIRECT RX TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-895_429ff009-936c-1e4c-e054-00144ff88e88 61919-895 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20161201 ANDA ANDA078783 DIRECT RX TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV E 20171231 61919-905_5dc82a54-d401-2b58-e053-2991aa0a7031 61919-905 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE ACETAMINOPHEN AND CODEINE TABLET ORAL 20171101 ANDA ANDA040779 DIRECT RX ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 61919-906_5dbf1a7f-3d89-a668-e053-2991aa0acacf 61919-906 HUMAN PRESCRIPTION DRUG DIAZEPAM DIAZEPAM TABLET ORAL 20161101 ANDA ANDA077749 DIRECT RX DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 61919-907_5dc7f5e2-260e-e241-e053-2991aa0aa4a0 61919-907 HUMAN PRESCRIPTION DRUG DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE CAPSULE ORAL 20171101 ANDA ANDA062676 DIRECT RX DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 61919-908_5dc7f5e2-25ff-e241-e053-2991aa0aa4a0 61919-908 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET, FILM COATED ORAL 20170101 ANDA ANDA040268 DIRECT RX PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 61919-909_5dc7f5e2-25ef-e241-e053-2991aa0aa4a0 61919-909 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20171101 ANDA ANDA077321 DIRECT RX LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61919-911_5dbf1a7f-3d5e-a668-e053-2991aa0acacf 61919-911 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE QUETIAPINE FUMARATE TABLET, FILM COATED ORAL 20171101 ANDA ANDA202152 DIRECT RX QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 61919-912_5dbf1a7f-3d73-a668-e053-2991aa0acacf 61919-912 HUMAN PRESCRIPTION DRUG TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE TABLET ORAL 20171101 ANDA ANDA071523 DIRECT RX TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 61919-913_5dac13e3-4f06-0528-e053-2a91aa0aac57 61919-913 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE E/R METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE ORAL 20171110 ANDA ANDA090617 DirectRX METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61919-914_5dab03d3-66c6-3311-e053-2a91aa0a0b71 61919-914 HUMAN PRESCRIPTION DRUG ATENOLOL ATENOLOL TABLET ORAL 20171110 ANDA ANDA077877 DIRECT RX ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61919-916_5dab03d3-66b4-3311-e053-2a91aa0a0b71 61919-916 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20171110 ANDA ANDA091650 DirectRX ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61919-917_5daa7cf3-d899-16a4-e053-2991aa0a4c08 61919-917 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20171110 ANDA ANDA077634 DIRECT RX ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 61919-919_35e38d4b-d11f-43f9-e054-00144ff8d46c 61919-919 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir CAPSULE ORAL 20150101 ANDA ANDA077478 Direct Rx VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 61919-920_b6cc4b45-4847-4334-9ce9-81fffcb96dbc 61919-920 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE ORAL 20150101 NDA AUTHORIZED GENERIC NDA020699 DIRECT RX VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-923_82d82270-8253-4850-b714-6f917aea6448 61919-923 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150101 ANDA ANDA074862 DIRECT RX MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-930_3f3cf86d-f621-3034-e054-00144ff8d46c 61919-930 HUMAN PRESCRIPTION DRUG FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE CREAM TOPICAL 20140101 ANDA ANDA077055 DIRECT RX FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 61919-931_3f3cd2f7-a3e2-1afe-e054-00144ff8d46c 61919-931 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN SOLUTION AURICULAR (OTIC) 20140101 ANDA ANDA078222 DIRECT RX OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 61919-935_54b0f669-7904-72c5-e054-00144ff8d46c 61919-935 HUMAN PRESCRIPTION DRUG ATENOLOL ATENOLOL TABLET ORAL 20170224 ANDA ANDA076900 DIRECT RX ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 61919-938_3423487c-80e4-6bff-e054-00144ff88e88 61919-938 HUMAN PRESCRIPTION DRUG EFFEXOR VENLAFAXINE TABLET ORAL 20160202 ANDA ANDA078627 DIRECT RX VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-940_be637ae2-4a14-4afd-ac91-099c39cc0829 61919-940 HUMAN PRESCRIPTION DRUG VENLAFAXINE VENLAFAXINE TABLET ORAL 20150101 ANDA ANDA078627 DirectRX VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 61919-941_3f3c51b7-8937-1028-e054-00144ff88e88 61919-941 HUMAN PRESCRIPTION DRUG LOVASTATIN LOVASTATIN TABLET ORAL 20140101 ANDA ANDA075991 DIRECT RX LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 61919-942_48f813f1-7010-3d8f-e054-00144ff8d46c 61919-942 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20170220 ANDA ANDA075994 DIRECT RX LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 61919-948_33c2a84c-1f20-0ee8-e054-00144ff8d46c 61919-948 HUMAN PRESCRIPTION DRUG AMBIEN ZOLPIDEM TARTRATE TABLET ORAL 20160210 ANDA ANDA076410 DIRECT RX ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 61919-950_32f6d89b-4aeb-5396-e054-00144ff88e88 61919-950 HUMAN PRESCRIPTION DRUG IMITREX SUMATRIPTAN TABLET ORAL 20160513 ANDA ANDA078327 DIRECTRX SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 61919-952_3710bc3a-ba01-61b1-e054-00144ff88e88 61919-952 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM LOSARTAN POTASSIUM TABLET ORAL 20140101 ANDA ANDA090467 DIRECT RX LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 61919-953_268a6117-0484-66b1-e054-00144ff88e88 61919-953 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140101 NDA AUTHORIZED GENERIC NDA018279 DIRECT RX POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 61919-954_3f3ca4c8-251a-19f7-e054-00144ff88e88 61919-954 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140101 ANDA ANDA090528 DIRECT RX HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 61919-955_bf1b22fc-d0f1-4204-a1f5-4302c0676616 61919-955 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA090107 DIRECT RX ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] E 20171231 61919-956_4636ca02-79c4-5a35-e054-00144ff8d46c 61919-956 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170116 ANDA ANDA091624 DIRECT RX ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 61919-960_6474319b-1aa5-460e-841a-8f797b815377 61919-960 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET ORAL 20150101 ANDA ANDA075682 DirectRX IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 61919-965_33accd6b-10a7-5bd3-e054-00144ff88e88 61919-965 HUMAN PRESCRIPTION DRUG BUSPAR BUSPIRONE HYDROCHLORIDE TABLET ORAL 20160503 ANDA ANDA078888 DIRECT RX BUSPIRONE HYDROCHLORIDE 5 mg/1 E 20171231 61919-966_d44ad9fe-fbf0-464b-8331-c9051a6b017e 61919-966 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150101 ANDA ANDA074862 DIRECT RX MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 61919-967_5c87947c-42a2-f79e-e053-2a91aa0a8e01 61919-967 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET ORAL 20171027 ANDA ANDA077836 direct rx GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 61919-968_261817da-b8d7-2b32-e054-00144ff8d46c 61919-968 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET ORAL 20151203 ANDA ANDA077836 DirectRX GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 61919-970_4eb46618-efa7-43d6-8b05-833a55a29b07 61919-970 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20150101 ANDA ANDA077912 DirectRX HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 61919-976_26042871-1fbb-5df6-e054-00144ff8d46c 61919-976 HUMAN PRESCRIPTION DRUG LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET ORAL 20151202 NDA AUTHORIZED GENERIC NDA021210 DirectRX LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 61919-979_48a7a01e-347f-45bf-e054-00144ff88e88 61919-979 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20170216 ANDA ANDA205085 DIRECT RX CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 61919-981_33d5265e-b4fc-2d47-e054-00144ff88e88 61919-981 HUMAN PRESCRIPTION DRUG MONODOX DOXYCYCLINE MONOHYDRATE CAPSULE ORAL 20160527 ANDA ANDA204446 DIERCT RX DOXYCYCLINE 100 mg/1 E 20171231 61919-982_27f7d51b-e5f6-061d-e054-00144ff8d46c 61919-982 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20150101 ANDA ANDA090705 DIRECT RX GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 61919-984_494be2b0-1459-481f-e054-00144ff88e88 61919-984 HUMAN PRESCRIPTION DRUG CARVEDILOL CARVEDILOL TABLET, FILM COATED ORAL 20170224 ANDA ANDA078332 DIRECT RX CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 61919-985_492419ef-c664-3880-e054-00144ff8d46c 61919-985 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN CAPSULE ORAL 20170222 NDA NDA018851 DIRECT RX INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 61919-986_3f3c2323-da2c-0aca-e054-00144ff88e88 61919-986 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20140101 ANDA ANDA090469 Direct Rx ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 61919-987_3f3ba51d-f102-6a4b-e054-00144ff88e88 61919-987 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET, FILM COATED ORAL 20140101 ANDA ANDA201043 DIRECT RX LEVOFLOXACIN 250 mg/1 E 20171231 61919-989_40f31994-e46a-0d3f-e054-00144ff88e88 61919-989 HUMAN PRESCRIPTION DRUG AK-POLY-BAC AK-POLY-BAC OINTMENT OPHTHALMIC 20140101 ANDA ANDA064028 DIRECT RX BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 61919-990_2b44622c-9502-0ab7-e054-00144ff8d46c 61919-990 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20160205 ANDA ANDA090564 Direct RX METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 61919-991_25eb24c7-052a-6eec-e054-00144ff8d46c 61919-991 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20151201 ANDA ANDA091166 DirectRX ESZOPICLONE 1 mg/1 CIV E 20171231 61919-992_286c9e47-6665-42ae-8fb5-e7dfa1b4703d 61919-992 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150101 ANDA ANDA076361 Direct RX LEVOFLOXACIN 500 mg/1 E 20171231 61919-994_44a8e065-e097-7122-e054-00144ff8d46c 61919-994 HUMAN PRESCRIPTION DRUG AMOXICILLIN AMOXICILLIN CAPSULE ORAL 20161227 ANDA ANDA065271 DIRECT RX AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 61919-995_98f419e3-31fe-4894-80f4-d32b765637e6 61919-995 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20150101 ANDA ANDA084283 DirectRX PREDNISONE 50 mg/1 E 20171231 61924-092_a83cc35a-bd62-4568-92f0-bd6503db14ef 61924-092 HUMAN OTC DRUG DERMAKLEEN ANTIMICROBIAL DRUG PRODUCT SOAP TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333A Dermarite Industries LLC CHLOROXYLENOL .002 g/mL N 20181231 61924-093_fce71fa0-5bed-4600-a7bd-00e71ffd730a 61924-093 HUMAN OTC DRUG KLEENFOAM OTC ANTIMICROBIAL DRUG PRODUCT AEROSOL, FOAM TOPICAL 20111212 OTC MONOGRAPH NOT FINAL part333A Dermarite Industries LLC CHLOROXYLENOL .005 g/mL N 20181231 61924-102_30652617-1c94-4b05-90b3-f952a17b7572 61924-102 HUMAN OTC DRUG HAND-E-FOAM OTC ANTIMICROBIAL DRUG PRODUCTS AEROSOL, FOAM TOPICAL 20020808 OTC MONOGRAPH NOT FINAL part333A DermaRite Industries, LLC BENZETHONIUM CHLORIDE .002 g/mL N 20181231 61924-106_5beba486-b8aa-6969-e053-2991aa0aa5b1 61924-106 HUMAN OTC DRUG GELRITE Hand Sanitizer GEL TOPICAL 20060425 OTC MONOGRAPH NOT FINAL part333A DERMARITE INDUSTRIES, LLC ALCOHOL 65 mL/100mL N 20181231 61924-107_89ed3c42-e05b-44a8-95b5-aa3fee0bee55 61924-107 HUMAN OTC DRUG SAN-E-FOAM OTC ANTIMICROBIAL DRUG PRODUCTS AEROSOL, FOAM TOPICAL 20121012 OTC MONOGRAPH NOT FINAL part333A Dermarite Industries LLC ALCOHOL .67 g/mL N 20181231 61924-174_5bc3f8a4-a04e-f0c7-e053-2a91aa0a22c4 61924-174 HUMAN OTC DRUG DermaCerin Skin Protectant OINTMENT TOPICAL 20161017 OTC MONOGRAPH FINAL part347 DermaRite Industries, LLC PETROLATUM 33 g/100g N 20181231 61924-184_5bc37618-d280-6a4d-e053-2991aa0ab247 61924-184 HUMAN OTC DRUG Dermaphor Skin Protectant OINTMENT TOPICAL 20161117 OTC MONOGRAPH FINAL part347 DermaRite Industries, LLC PETROLATUM 44 g/100g N 20181231 61924-188_274f00be-d796-4874-93d8-5c0e24fd551e 61924-188 HUMAN OTC DRUG DERMASARRA OTC TOPICAL ANALGESIC DRUG PRODUCTS LOTION TOPICAL 20100224 OTC MONOGRAPH NOT FINAL part348 DERMARITE INDUSTRIES, LLC MENTHOL; CAMPHOR (NATURAL) .005; .005 g/mL; g/mL N 20181231 61924-198_794b3bb1-ca08-4e28-8bbe-7f0a4eaa4f86 61924-198 HUMAN OTC DRUG PERIGIENE ANTIMICROBIAL DRUG PRODUCT SOAP TOPICAL 20111212 OTC MONOGRAPH NOT FINAL part333A Dermarite Industries LLC CHLOROXYLENOL .005 g/mL N 20181231 61924-204_3da1e7a2-bab5-49bb-b1af-e48a4acceb70 61924-204 HUMAN OTC DRUG PERIGUARD OTC Skin Protectant Drug Products OINTMENT TOPICAL 20110418 OTC MONOGRAPH FINAL part347 DermaRite Industries, LLC ZINC OXIDE .038 g/g N 20181231 61924-208_efc8102b-5d60-45b3-ae80-f1af266756f9 61924-208 HUMAN OTC DRUG 4-N-1 WASH OTC SKIN PROTECTANT DRUG PRODUCT CREAM TOPICAL 20100102 OTC MONOGRAPH FINAL part347 DermaRite Industries, LLC DIMETHICONE .01 g/g N 20181231 61924-212_3dac5e4b-d7d3-4119-88e6-050362d9aad0 61924-212 HUMAN OTC DRUG DERMASEPTIN OTC SKIN PROTECTANT DRUG PRODUCTS OINTMENT TOPICAL 20101025 OTC MONOGRAPH FINAL part347 DermaRite Industries, LLC ZINC OXIDE; MENTHOL .005; .005 g/g; g/g N 20181231 61924-214_5bd4173d-8795-3d28-e053-2991aa0a06a9 61924-214 HUMAN OTC DRUG DermaMed Skin Protectant OINTMENT TOPICAL 20161018 OTC MONOGRAPH FINAL part347 DermaRite Industries, LLC ALUMINUM HYDROXIDE 2 g/100g N 20181231 61924-232_153f29ab-f292-433a-8469-845ea185d07a 61924-232 HUMAN OTC DRUG Lanoderm OTC Skin Protectant Drug Products OINTMENT TOPICAL 20120416 OTC MONOGRAPH FINAL part347 Dermarite Industries LLC LANOLIN .3 g/100g N 20181231 61924-234_88adb3ed-8624-4e11-9af9-6cb6e3e1b24e 61924-234 HUMAN OTC DRUG DERMAGUNGAL ANTIMICROBIAL DRUG PRODUCTS CREAM TOPICAL 20051212 OTC MONOGRAPH FINAL part333C DermaRite industries, LLC MICONAZOLE NITRATE .02 g/100g N 20181231 61924-266_371b42b3-156c-4e31-9b3c-03c71a1c138a 61924-266 HUMAN OTC DRUG UTRASURE OTC ANTIPRESPIRANT DRUG PRODUCT SPRAY TOPICAL 20100224 OTC MONOGRAPH FINAL part350 DermaRite Industries LLC ALUMINUM SESQUICHLOROHYDRATE .15 g/100mL N 20181231 61924-405_6f56ad13-50ac-4030-b197-41dca375c491 61924-405 HUMAN OTC DRUG RENEW SKIN REPAIR OTC SKIN PROTECTANT DRUG PRODUCTS CREAM TOPICAL 20110303 OTC MONOGRAPH FINAL part347 Dermarite Industries LLC DIMETHICONE .015 g/100g N 20181231 61924-410_5bc03be4-6cfe-158b-e053-2991aa0a2c04 61924-410 HUMAN OTC DRUG Renew Dimethicone Skin Protectant Skin Protectant CREAM TOPICAL 20120315 OTC MONOGRAPH FINAL part347 Dermarite Industries LLC DIMETHICONE .05 g/100g N 20181231 61924-430_31905b37-ce7f-4600-b069-d77c9b043151 61924-430 HUMAN OTC DRUG RENEW BODY CLEANSER OTC SKIN PROTECTANT DRUG PRODUCTS LOTION TOPICAL 20120302 OTC MONOGRAPH FINAL part347 DermaRite Industries, LLC DIMETHICONE .01 g/g N 20181231 61924-435_5bd49bb0-03a8-562c-e053-2a91aa0a19d8 61924-435 HUMAN OTC DRUG Renew Periprotect Skin Protectant OINTMENT TOPICAL 20161018 OTC MONOGRAPH FINAL part347 DermaRite Industries, LLC ZINC OXIDE; DIMETHICONE 12; 1 g/100g; g/100g N 20181231 61935-001_00c5c9c2-30f4-4754-a04f-3cd6ee1482da 61935-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980114 UNAPPROVED MEDICAL GAS Centura Home Oxygen OXYGEN 995 mL/L E 20171231 61938-456_d37c02fb-1bed-4400-92d2-50a67e539beb 61938-456 HUMAN PRESCRIPTION DRUG INFASURF CALFACTANT SUSPENSION ENDOTRACHEAL 20110721 NDA NDA020521 Ony, Inc. CALFACTANT 35.7 mg/mL Alveolar Surface Tension Reduction [PE],Surfactant [EPC],Surfactant Activity [MoA] N 20181231 61939-810_ddf2a781-8150-4452-97df-a41ff3caeff3 61939-810 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20140501 ANDA ANDA040190 Mikah Pharma, LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 61941-0011_716275c2-7e41-4cce-b792-91d65ad32127 61941-0011 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 19940607 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0012_716275c2-7e41-4cce-b792-91d65ad32127 61941-0012 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 19940607 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0021_302a8a5e-b5d2-4820-a3b4-fc83310cb114 61941-0021 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 19940607 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0022_302a8a5e-b5d2-4820-a3b4-fc83310cb114 61941-0022 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 19940607 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0031_716275c2-7e41-4cce-b792-91d65ad32127 61941-0031 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0032_716275c2-7e41-4cce-b792-91d65ad32127 61941-0032 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0041_716275c2-7e41-4cce-b792-91d65ad32127 61941-0041 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0042_716275c2-7e41-4cce-b792-91d65ad32127 61941-0042 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0051_716275c2-7e41-4cce-b792-91d65ad32127 61941-0051 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0052_716275c2-7e41-4cce-b792-91d65ad32127 61941-0052 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0071_716275c2-7e41-4cce-b792-91d65ad32127 61941-0071 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20100201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0072_716275c2-7e41-4cce-b792-91d65ad32127 61941-0072 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20100201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0081_28f7f321-29f9-4a2e-a21f-6d2420eb755c 61941-0081 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20050201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0082_28f7f321-29f9-4a2e-a21f-6d2420eb755c 61941-0082 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20050201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0091_28f7f321-29f9-4a2e-a21f-6d2420eb755c 61941-0091 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20050201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0092_28f7f321-29f9-4a2e-a21f-6d2420eb755c 61941-0092 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20050201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0101_28f7f321-29f9-4a2e-a21f-6d2420eb755c 61941-0101 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20050201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0102_28f7f321-29f9-4a2e-a21f-6d2420eb755c 61941-0102 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20050201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 N 20181231 61941-0111_9df15ad0-033c-413e-9e3a-0124c8c2b620 61941-0111 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate LOZENGE ORAL 20030201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/1 E 20171231 61941-0114_b159e1b8-8acd-4b55-ae1a-9ea0045fc968 61941-0114 HUMAN OTC DRUG Cold-EEZE Plus Natural Multi-Symptom Relief Zinc Gluconate, Sambucus Nigra Flower, and Glycyrrhiza Glabra Leaf LOZENGE ORAL 20160101 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE; SAMBUCUS NIGRA FLOWER; GLYCYRRHIZA GLABRA LEAF 2; 2; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 61941-0122_04f96bd9-bf04-4cb8-b021-c38db949f1de 61941-0122 HUMAN OTC DRUG Organix Complete Menthol and Pectin LOZENGE ORAL 20101101 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. MENTHOL; PECTIN 2.5; 1.7 mg/1; mg/1 N 20181231 61941-0132_f5c05aa5-6b4c-4a6c-ba9b-2fe1cc8bce03 61941-0132 HUMAN OTC DRUG Organix Complete Menthol and Pectin LOZENGE ORAL 20101101 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. MENTHOL; PECTIN 2.5; 1.7 mg/1; mg/1 N 20181231 61941-0217_dbdde3f1-9364-47b6-aac0-d53b43d0a177 61941-0217 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate SPRAY ORAL 20110801 20190331 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/.5mL E 20171231 61941-0223_8c9e0e83-058b-4f5a-899f-03a0f80033c0 61941-0223 HUMAN OTC DRUG Cold-EEZE PLUS Immune Support Zinc Gluconate, ROSA CANINA LEAF, and ECHINACEA PURPUREA TABLET, ORALLY DISINTEGRATING ORAL 20130901 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE; ROSA CANINA LEAF; ECHINACEA PURPUREA 1; 1; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 61941-0224_77929b78-95c9-4d7e-a2ac-3de5fb40d5c4 61941-0224 HUMAN OTC DRUG Cold-EEZE Plus Immune Support Plus Energy ZINC GLUCONATE, ROSA CANINA LEAF, ECHINACEA PURPUREA, CAFFEINE, and PANAX NOTOGINSENG ROOT TABLET, ORALLY DISINTEGRATING ORAL 20130901 20230831 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE; ROSA CANINA LEAF; ECHINACEA PURPUREA; CAFFEINE; PANAX NOTOGINSENG ROOT 1; 1; 2; 1; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 61941-0225_c1cf8137-5dad-44d8-b08d-5404467e05b0 61941-0225 HUMAN OTC DRUG Cold-EEZE Daytime and Nighttime QuickMelts Zinc Gluconate, Valerian, and Chamomile KIT 20141201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. E 20171231 61941-0226_cdd481e7-f120-40ad-999e-1de9186f62bd 61941-0226 HUMAN OTC DRUG Cold-EEZE Natural Multi-Symptom Relief Zinc Gluconate, Sambucus Nigra Flower, Eupatorium Perfoliatum Flowering Top, Mentha Piperita, Myrrh, and Glycyrrhiza Glabra Leaf TABLET, ORALLY DISINTEGRATING ORAL 20141201 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE; SAMBUCUS NIGRA FLOWER; EUPATORIUM PERFOLIATUM FLOWERING TOP; MENTHA PIPERITA; MYRRH; GLYCYRRHIZA GLABRA LEAF 1; 1; 1; 2; 2; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 61941-0227_dbdde3f1-9364-47b6-aac0-d53b43d0a177 61941-0227 HUMAN OTC DRUG Cold-EEZE Zinc Gluconate SPRAY ORAL 20110801 20190331 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE 2 [hp_X]/.5mL E 20171231 61941-0229_7f819f4d-23b8-4b25-b6ae-f8755914db72 61941-0229 HUMAN OTC DRUG Cold-EEZE Natural Allergy Relief Onion, Eupatorium Perfoliatum Flowering Top, Buckwheat, Symplocarpus Foetidus Root, Sambucus Nigra Flower, Tussilago Farfara Leaf, Urtica Dioica, and Zinc Gluconate TABLET, DELAYED RELEASE ORAL 20160101 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ONION; EUPATORIUM PERFOLIATUM FLOWERING TOP; BUCKWHEAT; SYMPLOCARPUS FOETIDUS ROOT; SAMBUCUS NIGRA FLOWER; TUSSILAGO FARFARA LEAF; URTICA DIOICA; ZINC GLUCONATE 2; 1; 2; 2; 1; 1; 1; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 61941-0231_5071c8da-5b17-4ce2-bea3-e1cd03bca31d 61941-0231 HUMAN OTC DRUG Cold-EEZE Plus Nighttime Multi-Symptom Relief Zinc Gluconate, Eupatorium Perfoliatum Flowering Top, Sambucus Nigra Flower, Valerian, Chamomile, Mentha Piperita, Myrrh, and Glycyrrhiza Glabra Leaf TABLET, ORALLY DISINTEGRATING ORAL 20160815 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE; EUPATORIUM PERFOLIATUM FLOWERING TOP; SAMBUCUS NIGRA FLOWER; VALERIAN; CHAMOMILE; MENTHA PIPERITA; MYRRH; GLYCYRRHIZA GLABRA LEAF 1; 1; 1; 1; 2; 2; 2; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 61941-0234_ef7e17d8-9690-4497-8989-9d1ef9823db1 61941-0234 HUMAN OTC DRUG Cold-EEZE Gummies Plus Multi-Symptom Relief Cold and Flu Zinc Gluconate, Mentha Piperita, eupatorium perfoliatum flowering top, sambucus nigra flower, MYRRH, and GLYCYRRHIZA GLABRA LEAF TABLET, ORALLY DISINTEGRATING ORAL 20161001 UNAPPROVED HOMEOPATHIC ProPhase Labs, Inc. ZINC GLUCONATE; MENTHA PIPERITA; EUPATORIUM PERFOLIATUM FLOWERING TOP; SAMBUCUS NIGRA FLOWER; MYRRH; GLYCYRRHIZA GLABRA LEAF 1; 1; 2; 2; 2; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 61941-0300_fa35352a-3f97-4e21-be20-86ee94fc4919 61941-0300 HUMAN OTC DRUG Cold-EEZE Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride LIQUID ORAL 20160101 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL E 20171231 61941-0301_be7d15b9-9e4b-4dff-aad4-ea5b7df188db 61941-0301 HUMAN OTC DRUG Cold-EEZE Nighttime Cold and Flu Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride LIQUID ORAL 20160101 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL E 20171231 61941-0400_9c89c223-889a-455b-8fd7-ad7f49553bc7 61941-0400 HUMAN OTC DRUG Cold-EEZE Childrens Daytime Cough and Chest Congestion Relief Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 20160101 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/5mL; mg/5mL E 20171231 61941-0401_a56a8bf2-0414-4a19-8321-eba58c3d5ed5 61941-0401 HUMAN OTC DRUG Cold-EEZE Childrens Nighttime Cold and Cough Relief Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride LIQUID ORAL 20160101 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL E 20171231 61941-1002_4f391211-f806-4c0f-887b-d32759754a49 61941-1002 HUMAN OTC DRUG Kids-EEZE Chest Relief Guaifenesin TABLET, ORALLY DISINTEGRATING ORAL 20080901 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. GUAIFENESIN 100 mg/1 E 20171231 61941-1003_cb36368e-90be-4280-a39e-b83b854645c8 61941-1003 HUMAN OTC DRUG Kids-EEZE Cough and Cold Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20100901 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/1; mg/1 E 20171231 61941-1005_185301e7-69c9-43ef-93c1-e6dddeb153ad 61941-1005 HUMAN OTC DRUG Kids-EEZE Allergy Diphenhydramine Hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20100901 OTC MONOGRAPH FINAL part341 ProPhase Labs, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 E 20171231 61953-0001_0108fa25-c5af-46fe-9eba-4216648d3df6 61953-0001 PLASMA DERIVATIVE HUMAN ALBUMIN GRIFOLS ALBUMIN (HUMAN) SOLUTION INTRAVENOUS 19950217 BLA BLA103352 GRIFOLS USA, LLC ALBUMIN HUMAN 10 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 61953-0002_91113122-7a7e-4c30-84fa-d8d34d4c95ee 61953-0002 PLASMA DERIVATIVE HUMAN ALBUMIN GRIFOLS ALBUMIN (HUMAN) SOLUTION INTRAVENOUS 20030611 BLA BLA103352 GRIFOLS USA, LLC ALBUMIN HUMAN 12.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 61953-0004_6f457f1c-bb87-4801-b458-3119849933a3 61953-0004 PLASMA DERIVATIVE Flebogamma DIF Immune Globulin (Human) INJECTION, SOLUTION INTRAVENOUS 20061221 BLA BLA125077 GRIFOLS USA, LLC HUMAN IMMUNOGLOBULIN G .05 g/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 61953-0005_5af4dfb7-3ac9-415a-b593-836a7f89a748 61953-0005 PLASMA DERIVATIVE FLEBOGAMMA DIF IMMUNE GLOBULIN INTRAVENOUS (HUMAN) INJECTION, SOLUTION INTRAVENOUS 20100727 BLA BLA125077 GRIFOLS USA, LLC HUMAN IMMUNOGLOBULIN G 5 g/50mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 61957-0001_62d45eb1-656a-412c-e053-2a91aa0a5c1e 61957-0001 HUMAN OTC DRUG CD DiorSnow UV Protection BB Eye Sunscreen Creme 010 TITANIUM DIOXIDE CREAM TOPICAL 20120910 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 36.5 mg/mL N 20191231 61957-0002_62d45eb1-657a-412c-e053-2a91aa0a5c1e 61957-0002 HUMAN OTC DRUG CD DiorSnow UV Protection BB Eye Sunscreen Creme 020 TITANIUM DIOXIDE CREAM TOPICAL 20120910 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 36.5 mg/mL N 20191231 61957-0003_e92eeaea-38c8-4138-80c1-d0e17ffeabe3 61957-0003 HUMAN OTC DRUG DIORSKIN NUDE TAN BB CREME HEALTHY GLOW SKIN-PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF15 Tint 1 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20130124 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 21.9 mg/mL; mg/mL N 20181231 61957-0004_846e1455-d1d9-42a0-abdd-0cd0c3176cf9 61957-0004 HUMAN OTC DRUG DIORSKIN NUDE TAN BB CREME HEALTHY GLOW SKIN-PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF15 Tint 2 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 21.9 mg/mL; mg/mL N 20181231 61957-0005_62d472c7-2e65-d9f5-e053-2991aa0a6421 61957-0005 HUMAN OTC DRUG DIORSKIN NUDE BB CREME NUDE GLOW SKIN-PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF10 Tint 1 TITANIUM DIOXIDE CREAM TOPICAL 20130123 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 21.9 mg/mL N 20191231 61957-0006_6284c30a-80b8-6fbd-e053-2a91aa0a860b 61957-0006 HUMAN OTC DRUG DIORSKIN NUDE BB CREME NUDE GLOW SKIN-PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF10 Tint 2 TITANIUM DIOXIDE CREAM TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 21.9 mg/mL N 20191231 61957-0007_62d472c7-2e9c-d9f5-e053-2991aa0a6421 61957-0007 HUMAN OTC DRUG DIORSKIN NUDE BB CREME NUDE GLOW SKIN-PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF10 Tint 3 TITANIUM DIOXIDE CREAM TOPICAL 20130123 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 21.9 mg/mL N 20191231 61957-0008_62d472c7-2ead-d9f5-e053-2991aa0a6421 61957-0008 HUMAN OTC DRUG DIORSKIN NUDE BB CREME NUDE GLOW SKIN-PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF10 Tint 4 TITANIUM DIOXIDE CREAM TOPICAL 20130123 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 21.9 mg/mL N 20191231 61957-0010_fcbfd5ed-ae96-4001-8240-c5f76f6dd8c6 61957-0010 HUMAN OTC DRUG DiorSkin Nude 010 Ivory TITANIUM DIOXIDE POWDER TOPICAL 20100616 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 5.53 g/100g N 20181231 61957-0020_8389aa86-7cda-40da-aa77-099c46be09a1 61957-0020 HUMAN OTC DRUG DiorSkin Nude 020 Light Beige TITANIUM DIOXIDE POWDER TOPICAL 20100616 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 5.53 g/100g N 20181231 61957-0022_eab2dcb7-0033-4dec-aa1e-2604dbeef371 61957-0022 HUMAN OTC DRUG DiorSkin Nude 022 Cameo TITANIUM DIOXIDE POWDER TOPICAL 20100616 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 5.53 g/100g N 20181231 61957-0101_e79164a3-1b42-4268-a181-04c647a34a85 61957-0101 HUMAN OTC DRUG Dior Bronze Collagen Activ SPF 15 001 OXYBENZONE, OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20101123 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OXYBENZONE; OCTINOXATE; TITANIUM DIOXIDE 2; 6; 2.43 g/100g; g/100g; g/100g N 20181231 61957-0102_51c9a1b1-eecd-4675-b6e6-f78721dffadf 61957-0102 HUMAN OTC DRUG Dior Bronze Collagen Activ SPF 15 002 OXYBENZONE, OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20101123 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OXYBENZONE; OCTINOXATE; TITANIUM DIOXIDE 2; 6; 2.43 g/100g; g/100g; g/100g N 20181231 61957-0103_62d4609b-3509-a294-e053-2991aa0a0cd0 61957-0103 HUMAN OTC DRUG Dior Bronze Collagen Activ SPF 15 003 OXYBENZONE, OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20101123 20191212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OXYBENZONE; OCTINOXATE; TITANIUM DIOXIDE 2; 6; 2.43 g/100g; g/100g; g/100g N 20191231 61957-0104_62d4609b-3512-a294-e053-2991aa0a0cd0 61957-0104 HUMAN OTC DRUG Dior Bronze Collagen Activ SPF 15 004 OXYBENZONE, OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20101123 20191212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OXYBENZONE; OCTINOXATE; TITANIUM DIOXIDE 2; 6; 2.43 g/100g; g/100g; g/100g N 20191231 61957-0110_62d472c7-2ebe-d9f5-e053-2991aa0a6421 61957-0110 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 010 Ivory OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0111_62d472c7-2ecf-d9f5-e053-2991aa0a6421 61957-0111 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 011 Cream OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0112_6284e1fe-be39-69bf-e053-2991aa0a90ab 61957-0112 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 020 Light Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mg/100mL; mg/100mL N 20191231 61957-0113_62d4609b-351b-a294-e053-2991aa0a0cd0 61957-0113 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 021 Linen OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0114_62d45eb1-658a-412c-e053-2a91aa0a5c1e 61957-0114 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 022 Cameo OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0115_62d4609b-352c-a294-e053-2991aa0a0cd0 61957-0115 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 023 Peach OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0116_6284e1fe-be4a-69bf-e053-2991aa0a90ab 61957-0116 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 030 Medium Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 4.35 mg/100mL; mg/100mL N 20191231 61957-0117_62d45eb1-659b-412c-e053-2a91aa0a5c1e 61957-0117 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 031 Sand OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0118_62d4ae41-d401-3c8b-e053-2a91aa0a16a6 61957-0118 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 033 Apricot Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0119_62d45eb1-65ac-412c-e053-2a91aa0a5c1e 61957-0119 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 040 Honey Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0120_62d4bb32-1445-b4ad-e053-2991aa0abc48 61957-0120 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 041 Ochre OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0121_62d4bb32-1458-b4ad-e053-2991aa0abc48 61957-0121 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 050 Dark Beige OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0122_62d4c259-78f1-719c-e053-2a91aa0a35de 61957-0122 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 060 Mocha OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0123_62d4bb32-1469-b4ad-e053-2991aa0abc48 61957-0123 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 063 Amber OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0124_62d4ae41-d413-3c8b-e053-2a91aa0a16a6 61957-0124 HUMAN OTC DRUG CD DIORSKIN NUDE SKIN-GLOWING MAKEUP SUNSCREEN BROAD SPECTRUM SPF 15 070 Dark Brown OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120827 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 43.5 mg/mL; mg/mL N 20191231 61957-0310_31384263-5900-46f6-9539-9093880837e5 61957-0310 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 010 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL N 20181231 61957-0311_0f9babc6-a58f-4a99-8c2d-afd975ff11d1 61957-0311 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 011 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL N 20181231 61957-0320_abb41c47-708d-4672-90b9-988edb7a648f 61957-0320 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 020 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL N 20181231 61957-0321_7e4a3aa9-0bef-46b9-a69a-cd10edd2481d 61957-0321 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 021 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL N 20181231 61957-0322_60d1ec9a-f215-4e34-a062-fce3b591fe4e 61957-0322 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 022 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL N 20181231 61957-0323_26c69eb6-ef08-4e60-bf74-b942ea3e735b 61957-0323 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 023 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL N 20181231 61957-0330_278c20ce-b6c3-4f8b-8913-d5fa11e8ab71 61957-0330 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 030 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL N 20181231 61957-0332_d997b4dd-7ea0-49d2-901d-35c5fb399887 61957-0332 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 032 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL N 20181231 61957-0333_a70d80ce-d916-42dd-b5d0-576986d3d44a 61957-0333 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 033 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL N 20181231 61957-0340_bd353d5c-07af-44cc-af20-8bdd78d9061d 61957-0340 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 040 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL N 20181231 61957-0350_f58c9788-9871-4706-b179-a023f0ed953f 61957-0350 HUMAN OTC DRUG CD DiorSkin Forever Flawless Perfection Fusion Wear Makeup SPF 25 - 050 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110723 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 4; 2.37 mL/100mL; mL/100mL N 20181231 61957-0401_277cf22c-ab6f-4a6c-a468-9a716bddd446 61957-0401 HUMAN OTC DRUG CD - Dior Multi-perfection Tinted Moisturizer Natural Radiance 1 - SPF 20 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100824 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.49; 4.74 mL/100mL; mL/100mL N 20181231 61957-0402_62d4e5a4-4581-0b32-e053-2991aa0a1054 61957-0402 HUMAN OTC DRUG CD - Dior Multi-perfection Tinted Moisturizer Golden Radiance 2 - SPF 20 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100824 20191212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 54.9; 47.4 mg/mL; mg/mL N 20191231 61957-0403_62d4ea48-904c-b3b1-e053-2a91aa0abfe2 61957-0403 HUMAN OTC DRUG CD - Dior Multi-perfection Tinted Moisturizer Bronze Radiance 3 - SPF 20 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100824 20191212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 54.9; 47.4 mg/mL; mg/mL N 20191231 61957-0600_ad3e951d-d1fd-4346-92da-b4f3b4974eed 61957-0600 HUMAN OTC DRUG DIORSNOW White Reveal UVB Protection Sunscreen Pearly White SPF 50 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20120719 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.49; 3.55; 19 mL/100mL; mL/100mL; mL/100mL E 20171231 61957-0601_73ba93f0-e8d2-4932-be90-9ffd5add4631 61957-0601 HUMAN OTC DRUG DIORSNOW White Reveal UVB Protection Sunscreen Translucent SPF 50 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20120719 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.49; 3.55; 19 mL/100mL; mL/100mL; mL/100mL E 20171231 61957-0602_62d4e5a4-45ab-0b32-e053-2991aa0a1054 61957-0602 HUMAN OTC DRUG CD DIORSNOW White Reveal Fresh Transparency Liquid Foundation with Sunscreen Broad Spectrum SPF 30 010 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131227 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 35; 42 mg/mL; mg/mL N 20191231 61957-0603_62d4e5a4-45ba-0b32-e053-2991aa0a1054 61957-0603 HUMAN OTC DRUG CD DIORSNOW White Reveal Fresh Transparency Liquid Foundation with Sunscreen Broad Spectrum SPF 30 020 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131227 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 35; 42 mg/mL; mg/mL N 20191231 61957-0604_62d4e5a4-45d6-0b32-e053-2991aa0a1054 61957-0604 HUMAN OTC DRUG CD DIORSNOW White Reveal Fresh Transparency Liquid Foundation with Sunscreen Broad Spectrum SPF 30 021 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131227 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 35; 42 mg/mL; mg/mL N 20191231 61957-0700_62d4fd56-7802-bcc5-e053-2a91aa0aca75 61957-0700 HUMAN OTC DRUG DIORSNOW BB Creme 010 White Reveal UV Protection Sunscreen Broad Spectrum SPF 50 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20120718 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 74.9; 20; 42.6 mg/mL; mg/mL; mg/mL N 20191231 61957-0701_62d4bb32-147a-b4ad-e053-2991aa0abc48 61957-0701 HUMAN OTC DRUG DIORSNOW BB Creme 020 White Reveal UV Protection Sunscreen Broad Spectrum SPF 50 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20120719 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 74.9; 20; 42.6 mg/mL; mg/mL; mg/mL N 20191231 61957-0800_62d4fd56-7855-bcc5-e053-2a91aa0aca75 61957-0800 HUMAN OTC DRUG CD DIOR PRESTIGE White Collection Satin Brightening Eye Cream Sunscreen SPF 15 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120722 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 24.9 mg/mL; mg/mL N 20191231 61957-0820_9e6df888-cc4c-4cbe-a607-4d55c3adec26 61957-0820 HUMAN OTC DRUG CD CAPTURE TOTALE MULTI-PERFECTION MAKEUP BASE SUNSCREEN BROAD SPECTRUM SPF 25 OCTINOXATE CREAM TOPICAL 20140609 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 74.9; 38.4 mg/mL; mg/mL N 20181231 61957-0900_9d21cdbe-2329-4bf0-a71b-b20b87b19efa 61957-0900 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 010 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 61957-0901_1f2e83ba-8cb4-4143-b258-67855e7e5d3b 61957-0901 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 020 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 61957-0902_d3775bd8-54c5-43e0-9d9d-f586a1ae3a75 61957-0902 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 021 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 61957-0903_1f096e78-af0a-4a2a-9692-8561632a66ec 61957-0903 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 022 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 61957-0904_68ec4b75-be3f-44bc-9c75-29eeb70806cd 61957-0904 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 023 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 61957-0905_afa657c9-f379-449c-934d-b4718a8ad866 61957-0905 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 030 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 61957-0906_8bacea27-59c6-4798-90e2-a3589e6d450d 61957-0906 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 031 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 61957-0907_77c9ab11-da26-422d-a562-6369817ad4b7 61957-0907 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 032 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 61957-0908_1edc9d91-18c4-4668-8b3f-e9f3452f6ef9 61957-0908 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 040 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 61957-0909_deff735c-18b2-49a9-9342-aac44a6bd486 61957-0909 HUMAN OTC DRUG CD CAPTURE TOTALE Triple Correcting Serum Foundation Wrinkles-Dark Spots-Radiance with sunscreen Broad Spectrum SPF 25 050 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 31.6 mg/mL; mg/mL N 20181231 61957-1002_e68be1ff-edd5-4460-a8fb-ead190702acd 61957-1002 HUMAN OTC DRUG DiorSkin Nude 032 Sable Rose OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100610 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 2.97 g/100g; g/100g N 20181231 61957-1005_e0b83bd5-51a1-4352-80db-70e8c524408e 61957-1005 HUMAN OTC DRUG DiorSkin Nude 050 Cafe Moka OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100610 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 6; 2.97 g/100g; g/100g E 20171231 61957-1015_4c004032-785e-483e-aea4-634635114627 61957-1015 HUMAN OTC DRUG DiorSkin Nude 010 Ivory TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE; OCTINOXATE 3.16; 3 mL/100mL; mL/100mL N 20181231 61957-1017_97e5de21-78e2-434f-ad2d-dc8cfbeadf41 61957-1017 HUMAN OTC DRUG DiorSkin Nude 020 Light Beige TITANIUM DIOXIDE, OCTINOXATE EMULSION TOPICAL 20100605 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE; OCTINOXATE 3.16; 3 mL/100mL; mL/100mL N 20181231 61957-1030_42ae4c35-bcc2-4cc9-8514-244dfdcec30e 61957-1030 HUMAN OTC DRUG HYDRA LIFE BASE DE TEINT SERUM OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100608 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 7.49; 3.16 mL/100mL; mL/100mL N 20181231 61957-1040_61919df7-c09c-0cb9-e053-2a91aa0a5e1d 61957-1040 HUMAN OTC DRUG Dior Bronze Collagen-Activ OCTINOXATE PASTE TOPICAL 20100608 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE 75 mg/mL N 20181231 61957-1101_55954ffb-1ee8-4079-a6ed-ab9c9fe3bd39 61957-1101 HUMAN OTC DRUG HYDRA LIFE PRO-YOUTH SKIN TINT 1 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100525 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.49; 4.74 mL/100mL; mL/100mL N 20181231 61957-1102_17d2756c-7c08-4237-87db-22769b31aadc 61957-1102 HUMAN OTC DRUG HYDRA LIFE PRO-YOUTH SKIN TINT 2 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100525 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.49; 4.74 mL/100mL; mL/100mL N 20181231 61957-1103_6c878372-b7cd-4ae1-b54c-2bea130e676c 61957-1103 HUMAN OTC DRUG HYDRA LIFE PRO-YOUTH SKIN TINT 3 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100525 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.49; 4.74 mL/100mL; mL/100mL N 20181231 61957-1111_62d4ea48-9080-b3b1-e053-2a91aa0abfe2 61957-1111 HUMAN OTC DRUG HYDRALIFE BB CREME Enhancing Moisturizer For Immediate Beauty SPF 30 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20111015 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE 37.5; 35.5; 10 mg/mL; mg/mL; mg/mL N 20191231 61957-1112_6284c30a-80c9-6fbd-e053-2a91aa0a860b 61957-1112 HUMAN OTC DRUG CD HydraLife BB Creme Enhancing Sunscreen Moisturizer For Immediate Beauty Golden Peach Broad Spectrum SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.5; 10; 35.5 mg/mL; mg/mL; mg/mL N 20191231 61957-1113_6284ffa4-2f95-7b86-e053-2a91aa0a573e 61957-1113 HUMAN OTC DRUG CD HydraLife BB Creme Enhancing Sunscreen Moisturizer For Immediate Beauty Luminous Beige Broad Spectrum SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.5; 10; 35.5 mg/mL; mg/mL; mg/mL N 20191231 61957-1114_62850c57-e791-e8f4-e053-2a91aa0a70fc 61957-1114 HUMAN OTC DRUG CD HydraLife BB Creme Enhancing Sunscreen Moisturizer For Immediate Beauty Sunny Amber Broad Spectrum SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 37.5; 10; 35.5 mg/mL; mg/mL; mg/mL N 20191231 61957-1120_62d4c259-7905-719c-e053-2a91aa0a35de 61957-1120 HUMAN OTC DRUG CD HydraLife BB Eye Creme Enhancing Sunscreen Eye Illuminator Luminous Beige Broad Spectrum SPF 20 TITANIUM DIOXIDE CREAM TOPICAL 20130103 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 36.5 mg/mL N 20191231 61957-1121_62d4e5a4-45e5-0b32-e053-2991aa0a1054 61957-1121 HUMAN OTC DRUG CD HydraLife BB Eye Creme Enhancing Sunscreen Eye Illuminator Luminous Peach Broad Spectrum SPF 20 TITANIUM DIOXIDE CREAM TOPICAL 20130103 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 36.5 mg/mL N 20191231 61957-1310_62d4fd56-7866-bcc5-e053-2a91aa0aca75 61957-1310 HUMAN OTC DRUG DiorSnow White Reveal Instant Spot Concealer SPF 50 Ivory 010 OCTINOXATE EMULSION TOPICAL 20110113 20201212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 74.9; 25 mg/mL; mg/mL N 20191231 61957-1320_d6113249-2cf6-4de2-b848-3b2bf1165230 61957-1320 HUMAN OTC DRUG DiorSnow White Reveal Instant Spot Concealer SPF 50 Light Beige 020 OCTINOXATE EMULSION TOPICAL 20110113 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE 7.49; 2.5 mL/100mL; mL/100mL E 20171231 61957-1412_03938686-8162-4bad-91c1-2d0690e19a90 61957-1412 HUMAN OTC DRUG Capture Totale Radiance Restoring Serum Foundation SPF 15 012 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL N 20181231 61957-1420_9a132f01-63d7-4b49-9e47-f96baee8f6e3 61957-1420 HUMAN OTC DRUG Capture Totale Radiance Restoring Serum Foundation SPF 15 020 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL N 20181231 61957-1430_122e617d-3c1e-47ee-95f2-5c0ff1a57b1a 61957-1430 HUMAN OTC DRUG Capture Totale Radiance Restoring Serum Foundation SPF 15 030 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101216 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 3; 3.16 mL/100mL; mL/100mL N 20181231 61957-1461_62d4fd56-7875-bcc5-e053-2a91aa0aca75 61957-1461 HUMAN OTC DRUG CD CAPTURE TOTALE Multi-Perfection UVB Base Sunscreen SPF 50 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130211 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 74.9; 20; 88.8 mg/mL; mg/mL; mg/mL N 20191231 61957-1470_af0be53e-5823-444a-b696-0cb8e37dda0f 61957-1470 HUMAN OTC DRUG CAPTURE TOTALE COMPACT RADIANCE RESTORING LINE SMOOTHING MAKEUP SPF 20 010 Ivory OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20111219 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g N 20181231 61957-1471_8a286243-dba1-41cb-aa8b-58b8066e0bbd 61957-1471 HUMAN OTC DRUG CAPTURE TOTALE COMPACT RADIANCE RESTORING LINE SMOOTHING MAKEUP SPF 20 020 Light Beige OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20111219 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g N 20181231 61957-1472_861c23e4-7c71-413b-9ecc-898cc1e86f24 61957-1472 HUMAN OTC DRUG CAPTURE TOTALE COMPACT RADIANCE RESTORING LINE SMOOTHING MAKEUP SPF 20 021 Linen OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20111219 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g N 20181231 61957-1473_00b286fc-9aea-42e2-b2f5-6295ba9e8b4b 61957-1473 HUMAN OTC DRUG CAPTURE TOTALE COMPACT RADIANCE RESTORING LINE SMOOTHING MAKEUP SPF 20 023 Peach OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20111219 OTC MONOGRAPH FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 5.99; .54 g/100g; g/100g N 20181231 61957-1501_62d4fd56-7886-bcc5-e053-2a91aa0aca75 61957-1501 HUMAN OTC DRUG CD DiorSnow UV Shield Transluscent - SPF50 ZINC OXIDE, OCTINOXATE LIQUID TOPICAL 20100824 20191212 OTC MONOGRAPH FINAL part352 Parfums Christian Dior ZINC OXIDE; OCTINOXATE 190; 75 mg/mL; mg/mL N 20191231 61957-1520_76ca940c-d534-4bc5-8b7d-35fd2edf3384 61957-1520 HUMAN OTC DRUG CD DIORSNOW UV SHIELD Brightening Illuminating UV Protection With Sunscreen TRANSLUCENT BROAD SPECTRUM SPF 50 ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20140807 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE 187; 74.9; 21.3; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 61957-2100_62d5166a-2b8b-44b5-e053-2991aa0a6cfb 61957-2100 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 010 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2101_62d51e9e-6fe6-f77b-e053-2a91aa0a104c 61957-2101 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 020 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2102_62d4e5a4-45f6-0b32-e053-2991aa0a1054 61957-2102 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 021 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2103_62d4e5a4-4605-0b32-e053-2991aa0a1054 61957-2103 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 022 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2104_62d4e5a4-4614-0b32-e053-2991aa0a1054 61957-2104 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 023 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2105_62d4fd56-7892-bcc5-e053-2a91aa0aca75 61957-2105 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 030 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2106_62d4e5a4-4624-0b32-e053-2991aa0a1054 61957-2106 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 031 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2107_62d4fd56-78a1-bcc5-e053-2a91aa0aca75 61957-2107 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 032 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2108_62d4e5a4-4633-0b32-e053-2991aa0a1054 61957-2108 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 033 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2109_62d4fd56-78b0-bcc5-e053-2a91aa0aca75 61957-2109 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 040 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2110_62d5166a-2b9a-44b5-e053-2991aa0a6cfb 61957-2110 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 050 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2111_62d5166a-2ba9-44b5-e053-2991aa0a6cfb 61957-2111 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 060 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2112_62d5166a-2bb8-44b5-e053-2991aa0a6cfb 61957-2112 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 070 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2113_62d5166a-2bc7-44b5-e053-2991aa0a6cfb 61957-2113 HUMAN OTC DRUG CD DIORSKIN STAR Studio Makeup Spectacular Brightening with sunscreen Broad Spectrum SPF30 080 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20140610 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 59.9; 35 mg/mL; mg/mL N 20191231 61957-2120_23bf33c6-fc7e-16cb-e054-00144ff8d46c 61957-2120 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 Ivory 010 OCTINOXATE LOTION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL N 20181231 61957-2121_23bde802-d874-1ecc-e054-00144ff88e88 61957-2121 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 020 Light Beige OCTINOXATE LOTION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL N 20181231 61957-2122_23bde802-d856-1ecc-e054-00144ff88e88 61957-2122 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 021 Linen OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL N 20181231 61957-2123_23d1b280-8516-1696-e054-00144ff8d46c 61957-2123 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 023 Peach OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL N 20181231 61957-2124_23d1b573-57aa-18f9-e054-00144ff8d46c 61957-2124 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 030 Medium OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL N 20181231 61957-2125_23d1b280-8517-1696-e054-00144ff8d46c 61957-2125 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 033 Apricot Beige OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL N 20181231 61957-2126_23be592a-e6fd-654c-e054-00144ff8d46c 61957-2126 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 040 Honey Beige OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL N 20181231 61957-2127_23be7076-e6b3-3465-e054-00144ff88e88 61957-2127 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 050 Dark Beige OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL N 20181231 61957-2128_23d20809-6b33-2951-e054-00144ff8d46c 61957-2128 HUMAN OTC DRUG DIORSKIN NUDE AIR Nude Healthy Glow Ultra-Fluid Serum Foundation with Sunscreen Broad Spectrum SPF25 060 Mocha OCTINOXATE LOTION TOPICAL 20141012 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL N 20181231 61957-2130_ff589562-669f-4745-a54c-c00154754595 61957-2130 HUMAN OTC DRUG DIORSKIN NUDE BB CREME NUDE GLOW SKIN-PERFECTING BEAUTY BALM WITH SUNSCREEN BROAD SPECTRUM SPF10 025 TITANIUM DIOXIDE CREAM TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE 1 mg/mL E 20171231 61957-2140_d3fb95be-551a-48f6-aa38-18c83b0d52b2 61957-2140 HUMAN OTC DRUG CD DIORSNOW Bloom Perfect Brightening Perfect Skin Creator With Sunscreen Broad Spectrum SPF35 OCTINOXATE, OXYBENZONE, ZINC OXIDE EMULSION TOPICAL 20150403 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; ZINC OXIDE 74.9; 30; 110 mg/mL; mg/mL; mg/mL E 20171231 61957-2150_a63a0a39-894c-49f7-a793-2e583db77520 61957-2150 HUMAN OTC DRUG CD DIORSKIN CITY DEFENSE Toxin Shield Pollution UV Advanced Protection with sunscreen Broad Spectrum SPF50 OCTINOXATE, OXYBENZONE, ZINC OXIDE LIQUID TOPICAL 20140924 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; OXYBENZONE; ZINC OXIDE 4.49; 2; 20.9 mg/mL; mg/mL; mg/mL N 20181231 61957-2160_62d53b42-f774-33d9-e053-2a91aa0ae8c5 61957-2160 HUMAN OTC DRUG The UV Protector Youth and Radiance With Sunscreen Blemish Balm Broad Spectrum SPF50 OXYBENZONE, OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20150403 20191212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OXYBENZONE; OCTINOXATE; TITANIUM DIOXIDE 20; 74.9; 42.6 mg/mL; mg/mL; mg/mL N 20191231 61957-2200_231d1fda-2c5a-27ae-e054-00144ff8d46c 61957-2200 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 010 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151021 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2201_231cf490-29f1-6ae6-e054-00144ff88e88 61957-2201 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 020 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151021 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2202_231cb798-aa01-61a0-e054-00144ff88e88 61957-2202 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 021 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151021 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2203_231d1fda-2c69-27ae-e054-00144ff8d46c 61957-2203 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 022 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151021 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2204_231cb798-a9da-61a0-e054-00144ff88e88 61957-2204 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 023 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151021 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2205_231d1fda-2ca5-27ae-e054-00144ff8d46c 61957-2205 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 030 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151021 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2206_231cb798-a9ec-61a0-e054-00144ff88e88 61957-2206 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 031 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151022 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2207_231d1fda-2c96-27ae-e054-00144ff8d46c 61957-2207 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 032 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151022 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2208_231cb798-aa14-61a0-e054-00144ff88e88 61957-2208 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 033 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151022 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2209_231caad0-fff0-6250-e054-00144ff88e88 61957-2209 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 034 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151022 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2210_231d1fda-2c78-27ae-e054-00144ff8d46c 61957-2210 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 035 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151022 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2211_231d1fda-2cb4-27ae-e054-00144ff8d46c 61957-2211 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 040 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151022 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2212_231cf490-2a00-6ae6-e054-00144ff88e88 61957-2212 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 050 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151023 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2213_231caad0-ffff-6250-e054-00144ff88e88 61957-2213 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 060 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151023 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2214_231d1fda-2c87-27ae-e054-00144ff8d46c 61957-2214 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 070 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151023 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2215_231d59b6-f20c-32b6-e054-00144ff8d46c 61957-2215 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 080 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151023 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2216_231caad0-ffe1-6250-e054-00144ff88e88 61957-2216 HUMAN OTC DRUG DIORSKIN FOREVER EVER WEAR Extreme Perfection Hold Makeup Base with Sunscreen SPF20 001 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20151023 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 40; 43.8 mg/mL; mg/mL N 20181231 61957-2217_62d53b42-f783-33d9-e053-2a91aa0ae8c5 61957-2217 HUMAN OTC DRUG Hydra Life Water BB SPF 30 Shade 010 BENZOPHENONE-3, OCTINOXATE, PHENYLBENZIMIDAZOLE SULFONIC ACID, TITANIUM DIOXIDE EMULSION TOPICAL 20160117 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OXYBENZONE; OCTINOXATE; ENSULIZOLE; TITANIUM DIOXIDE 30; 74.9; 20; 32 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 61957-2218_62d5166a-2bd6-44b5-e053-2991aa0a6cfb 61957-2218 HUMAN OTC DRUG Hydra Life Water BB SPF 30 Shade 020 BENZOPHENONE-3, OCTINOXATE, PHENYLBENZIMIDAZOLE SULFONIC ACID, TITANIUM DIOXIDE EMULSION TOPICAL 20160117 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OXYBENZONE; OCTINOXATE; ENSULIZOLE; TITANIUM DIOXIDE 30; 74.9; 20; 32 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 61957-2219_62d53b42-f793-33d9-e053-2a91aa0ae8c5 61957-2219 HUMAN OTC DRUG Hydra Life Water BB SPF 30 Shade 030 BENZOPHENONE-3, OCTINOXATE, PHENYLBENZIMIDAZOLE SULFONIC ACID, TITANIUM DIOXIDE EMULSION TOPICAL 20160117 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OXYBENZONE; OCTINOXATE; ENSULIZOLE; TITANIUM DIOXIDE 30; 74.9; 20; 32 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 61957-2220_612d2bd5-6321-fcbc-e053-2a91aa0a6112 61957-2220 HUMAN OTC DRUG Capture Totale Dreamskin Perfect Skin Cushion Youth Skincare Perfect Complexion Creator With Sunscreen Broad Spectrum SPF 50 010 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE EMULSION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2221_612d2bd5-6313-fcbc-e053-2a91aa0a6112 61957-2221 HUMAN OTC DRUG Capture Totale Dreamskin Perfect Skin Cushion Youth Skincare Perfect Complexion Creator With Sunscreen Broad Spectrum SPF 50 012 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE EMULSION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2222_612d2bd5-632f-fcbc-e053-2a91aa0a6112 61957-2222 HUMAN OTC DRUG Capture Totale Dreamskin Perfect Skin Cushion Youth Skincare Perfect Complexion Creator With Sunscreen Broad Spectrum SPF 50 020 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE EMULSION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2223_612cabf1-0871-3d4e-e053-2a91aa0aa85b 61957-2223 HUMAN OTC DRUG Capture Totale Dreamskin Perfect Skin Cushion Youth Skincare Perfect Complexion Creator With Sunscreen Broad Spectrum SPF 50 030 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE EMULSION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2224_3877912c-a954-0a50-e054-00144ff88e88 61957-2224 HUMAN OTC DRUG DIOR PRESTIGE LE NECTAR DE TEINT Exceptional Revitalizing Foundation Satin Radiance with Sunscreen Broad Spectrum SPF20 TINTS 010 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160723 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 29.2 mg/mL; mg/mL N 20181231 61957-2225_3877912c-a963-0a50-e054-00144ff88e88 61957-2225 HUMAN OTC DRUG DIOR PRESTIGE LE NECTAR DE TEINT Exceptional Revitalizing Foundation Satin Radiance with Sunscreen Broad Spectrum SPF20 TINTS 020 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160723 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 29.2 mg/mL; mg/mL N 20181231 61957-2226_3877912c-a972-0a50-e054-00144ff88e88 61957-2226 HUMAN OTC DRUG DIOR PRESTIGE LE NECTAR DE TEINT Exceptional Revitalizing Foundation Satin Radiance with Sunscreen Broad Spectrum SPF20 TINTS 021 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160723 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 29.2 mg/mL; mg/mL N 20181231 61957-2227_3877912c-a981-0a50-e054-00144ff88e88 61957-2227 HUMAN OTC DRUG DIOR PRESTIGE LE NECTAR DE TEINT Exceptional Revitalizing Foundation Satin Radiance with Sunscreen Broad Spectrum SPF20 TINTS 030 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160723 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 29.2 mg/mL; mg/mL N 20181231 61957-2228_612d2bd5-633d-fcbc-e053-2a91aa0a6112 61957-2228 HUMAN OTC DRUG Capture Totale Dreamskin Perfect Skin Cushion Youth Skincare Perfect Complexion Creator With Sunscreen Broad Spectrum SPF 50 21 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE EMULSION TOPICAL 20160811 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2229_612d2bd5-634b-fcbc-e053-2a91aa0a6112 61957-2229 HUMAN OTC DRUG Capture Totale Dreamskin Perfect Skin Cushion Youth Skincare Perfect Complexion Creator With Sunscreen Broad Spectrum SPF 50 25 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE EMULSION TOPICAL 20160811 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2230_612d2bd5-6359-fcbc-e053-2a91aa0a6112 61957-2230 HUMAN OTC DRUG Capture Totale Dreamskin Perfect Skin Cushion Youth Skincare Perfect Complexion Creator With Sunscreen Broad Spectrum SPF 50 40 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE EMULSION TOPICAL 20160811 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2600_3ed6cbe6-4c24-2352-e054-00144ff88e88 61957-2600 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 tints 014 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20161014 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2601_3ed6c98a-1306-1e8d-e054-00144ff88e88 61957-2601 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 tints 015 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20161014 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2603_3ed6bf70-2822-04f8-e054-00144ff8d46c 61957-2603 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 tints 024 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20161014 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2604_3ed69a3b-d72b-1ec7-e054-00144ff88e88 61957-2604 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 tints 025 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20161014 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2605_3ed69a3b-d73a-1ec7-e054-00144ff88e88 61957-2605 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 tints 041 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20161014 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2607_3ed6c98a-1319-1e8d-e054-00144ff88e88 61957-2607 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 tints 044 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20161014 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2608_3ed6bf70-2833-04f8-e054-00144ff8d46c 61957-2608 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 tints 045 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20161014 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2609_3ed6c98a-1328-1e8d-e054-00144ff88e88 61957-2609 HUMAN OTC DRUG DIORSKIN FOREVER Perfect Makeup Everlasting Wear Pore-Refining Effect with Sunscreen Broad Spectrum SPF 35 tints 051 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20161014 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 30; 17.5 mg/mL; mg/mL N 20181231 61957-2610_3f298cf6-ef41-09da-e054-00144ff8d46c 61957-2610 HUMAN OTC DRUG DIORSKIN NUDE AIR LUMINIZER Fluide Illuminateur Bonne Mine Naturelle Healthy Glow Liquid Luminizer with Sunscreen Broad Spectrum SPF 8 OCTINOXATE EMULSION TOPICAL 20161015 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE 74.9 mg/mL N 20181231 61957-2611_3f28df63-8133-4e98-e054-00144ff8d46c 61957-2611 HUMAN OTC DRUG DIORSNOW Teint Fraicheur Eclaircissant White Reveal Fresh Transparency Liquid Foundation with Sunscreen Broad Spectrum SPF30 tints 020 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20161015 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 35; 40.2 mg/mL; mg/mL N 20181231 61957-2612_3f29ba67-9d73-0577-e054-00144ff8d46c 61957-2612 HUMAN OTC DRUG DIORSNOW Teint Fraicheur Eclaircissant White Reveal Fresh Transparency Liquid Foundation with Sunscreen Broad Spectrum SPF30 tints 021 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20161015 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 35; 40.2 mg/mL; mg/mL N 20181231 61957-2613_3f29c982-8200-12b4-e054-00144ff88e88 61957-2613 HUMAN OTC DRUG DIORSNOW Teint Fraicheur Eclaircissant White Reveal Fresh Transparency Liquid Foundation with Sunscreen Broad Spectrum SPF30 tints 010 OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20161015 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE 35; 40.2 mg/mL; mg/mL N 20181231 61957-2700_4a2af7fc-f26a-10b6-e054-00144ff8d46c 61957-2700 HUMAN OTC DRUG DIOR HOMME SANS ALCOHOL FREE ANTIPERSPIRANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY PASTE TOPICAL 20170103 OTC MONOGRAPH FINAL part350 Parfums Christian Dior ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 150 mg/g N 20181231 61957-2751_612d2bd5-6367-fcbc-e053-2a91aa0a6112 61957-2751 HUMAN OTC DRUG DiorSkin forever Perfect Cushion Perfect Fresh Makeup Everlasting Luminous Matte Finish Pore-Refining Effect with Sunscreen Broad Spectrum SPF35 010 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20170314 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2752_612d2bd5-6375-fcbc-e053-2a91aa0a6112 61957-2752 HUMAN OTC DRUG DiorSkin forever Perfect Cushion Perfect Fresh Makeup Everlasting Luminous Matte Finish Pore-Refining Effect with Sunscreen Broad Spectrum SPF35 011 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20170314 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2753_612d2bd5-6383-fcbc-e053-2a91aa0a6112 61957-2753 HUMAN OTC DRUG DiorSkin forever Perfect Cushion Perfect Fresh Makeup Everlasting Luminous Matte Finish Pore-Refining Effect with Sunscreen Broad Spectrum SPF35 020 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20170314 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2754_612d2bd5-6391-fcbc-e053-2a91aa0a6112 61957-2754 HUMAN OTC DRUG DiorSkin forever Perfect Cushion Perfect Fresh Makeup Everlasting Luminous Matte Finish Pore-Refining Effect with Sunscreen Broad Spectrum SPF35 021 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20170314 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2755_612d2bd5-639f-fcbc-e053-2a91aa0a6112 61957-2755 HUMAN OTC DRUG DiorSkin forever Perfect Cushion Perfect Fresh Makeup Everlasting Luminous Matte Finish Pore-Refining Effect with Sunscreen Broad Spectrum SPF35 030 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20170314 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2756_612d2bd5-63ad-fcbc-e053-2a91aa0a6112 61957-2756 HUMAN OTC DRUG DiorSkin forever Perfect Cushion Perfect Fresh Makeup Everlasting Luminous Matte Finish Pore-Refining Effect with Sunscreen Broad Spectrum SPF35 040 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20170314 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 70; 41.5; 98 mg/g; mg/g; mg/g N 20181231 61957-2800_612d2bd5-63c5-fcbc-e053-2a91aa0a6112 61957-2800 HUMAN OTC DRUG DIOR HOMME Eau For Men ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY KIT 20170314 OTC MONOGRAPH FINAL part350 Parfums Christian Dior N 20181231 61957-9401_481160f2-ed3e-46e3-990d-944973f0e729 61957-9401 HUMAN OTC DRUG DIORPRESTIGE WHITE COLLECTION SATIN BRIGHTENING UV BASE SPF 50 TITANIUM DIOXIDE, OCTINOXATE, OXYBENZONE CREAM TOPICAL 20111014 OTC MONOGRAPH FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE; OCTINOXATE; OXYBENZONE 8.88; 7.49; 2 mL/100mL; mL/100mL; mL/100mL N 20181231 61957-9404_62d53b42-f7a2-33d9-e053-2a91aa0ae8c5 61957-9404 HUMAN OTC DRUG CD DIOR PRESTIGE WHITE COLLECTION SATIN BRIGHTENING UVB BASE WITH SUNSCREEN SPF 50 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20140206 20201212 OTC MONOGRAPH NOT FINAL part352 Parfums Christian Dior TITANIUM DIOXIDE; OXYBENZONE; OCTINOXATE 88.8; 20; 74.9 mg/mL; mg/mL; mg/mL N 20191231 61958-0101_cc1a8d88-6b17-49dd-9e47-a19a3a4b0f44 61958-0101 HUMAN PRESCRIPTION DRUG Vistide CIDOFOVIR INJECTION INTRAVENOUS 19960626 NDA NDA020638 Gilead Sciences, Inc. CIDOFOVIR 75 mg/mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient] N 20181231 61958-0401_7d7281c5-c85d-4eb9-b859-422fb521b293 61958-0401 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED ORAL 20011026 NDA NDA021356 Gilead Sciences, Inc. TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-0403_7d7281c5-c85d-4eb9-b859-422fb521b293 61958-0403 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE POWDER ORAL 20120118 NDA NDA022577 Gilead Sciences, Inc. TENOFOVIR DISOPROXIL FUMARATE 40 mg/g Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-0404_7d7281c5-c85d-4eb9-b859-422fb521b293 61958-0404 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED ORAL 20120118 NDA NDA021356 Gilead Sciences, Inc. TENOFOVIR DISOPROXIL FUMARATE 150 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-0405_7d7281c5-c85d-4eb9-b859-422fb521b293 61958-0405 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED ORAL 20120118 NDA NDA021356 Gilead Sciences, Inc. TENOFOVIR DISOPROXIL FUMARATE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-0406_7d7281c5-c85d-4eb9-b859-422fb521b293 61958-0406 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED ORAL 20120118 NDA NDA021356 Gilead Sciences, Inc. TENOFOVIR DISOPROXIL FUMARATE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-0501_22dc9759-59c6-4683-a461-6cdea36beabf 61958-0501 HUMAN PRESCRIPTION DRUG Hepsera adefovir dipivoxil TABLET ORAL 20020920 NDA NDA021449 Gilead Sciences, Inc. ADEFOVIR DIPIVOXIL 10 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-0601_9d004165-8e41-4b34-97e5-fca88062969c 61958-0601 HUMAN PRESCRIPTION DRUG Emtriva EMTRICITABINE CAPSULE ORAL 20030702 NDA NDA021500 Gilead Sciences, Inc. EMTRICITABINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-0602_9d004165-8e41-4b34-97e5-fca88062969c 61958-0602 HUMAN PRESCRIPTION DRUG Emtriva EMTRICITABINE SOLUTION ORAL 20050928 NDA NDA021896 Gilead Sciences, Inc. EMTRICITABINE 10 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-0701_684d143e-3b39-4f67-83d5-36c914841582 61958-0701 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20040802 NDA NDA021752 Gilead Sciences, Inc EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-0703_684d143e-3b39-4f67-83d5-36c914841582 61958-0703 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20160310 NDA NDA021752 Gilead Sciences, Inc EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 100; 150 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-0704_684d143e-3b39-4f67-83d5-36c914841582 61958-0704 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20160310 NDA NDA021752 Gilead Sciences, Inc EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 133; 200 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-0705_684d143e-3b39-4f67-83d5-36c914841582 61958-0705 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20160310 NDA NDA021752 Gilead Sciences, Inc EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 167; 250 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-0801_bb56fca3-fff9-4212-ba49-4959ad5a269e 61958-0801 HUMAN PRESCRIPTION DRUG Letairis AMBRISENTAN TABLET, FILM COATED ORAL 20070615 NDA NDA022081 Gilead Sciences, Inc AMBRISENTAN 5 mg/1 Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA] N 20181231 61958-0802_bb56fca3-fff9-4212-ba49-4959ad5a269e 61958-0802 HUMAN PRESCRIPTION DRUG Letairis AMBRISENTAN TABLET, FILM COATED ORAL 20070615 NDA NDA022081 Gilead Sciences, Inc AMBRISENTAN 10 mg/1 Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA] N 20181231 61958-0901_0d2b8cc7-2781-44e4-8aa7-f613eebb87db 61958-0901 HUMAN PRESCRIPTION DRUG Cayston aztreonam KIT 20100222 NDA NDA050814 Gilead Sciences, Inc. N 20181231 61958-1001_91f49ac7-d683-4c63-9b79-355c13cc28e4 61958-1001 HUMAN PRESCRIPTION DRUG Ranexa ranolazine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060127 NDA NDA021526 Gilead Sciences, Inc. RANOLAZINE 500 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 61958-1002_91f49ac7-d683-4c63-9b79-355c13cc28e4 61958-1002 HUMAN PRESCRIPTION DRUG Ranexa ranolazine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070212 NDA NDA021526 Gilead Sciences, Inc. RANOLAZINE 1000 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 61958-1003_4d2004e3-4c13-45fe-bf5a-92c7146691e8 61958-1003 HUMAN PRESCRIPTION DRUG Ranexa RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060127 NDA NDA021526 Gilead Sciences, Inc. RANOLAZINE 500 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 61958-1004_4d2004e3-4c13-45fe-bf5a-92c7146691e8 61958-1004 HUMAN PRESCRIPTION DRUG Ranexa RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070212 NDA NDA021526 Gilead Sciences, Inc. RANOLAZINE 1000 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 61958-1101_d0a49630-41b4-4e28-a548-2c2a085b9bcd 61958-1101 HUMAN PRESCRIPTION DRUG COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20110810 NDA NDA202123 Gilead Sciences, Inc. EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE 200; 25; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [Chemical/Ingredient],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-1201_e399801b-ed56-45b5-95a8-6721fa616a99 61958-1201 HUMAN PRESCRIPTION DRUG Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20120827 NDA NDA203100 Gilead Sciences, Inc. ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 150; 150; 200; 300 mg/1; mg/1; mg/1; mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-1401_a7e53701-1c4c-428e-8df6-61e816c730d5 61958-1401 HUMAN PRESCRIPTION DRUG Tybost COBICISTAT TABLET, FILM COATED ORAL 20140924 NDA NDA203094 Gilead Sciences, Inc. COBICISTAT 150 mg/1 Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 61958-1501_de7d750b-e890-4956-b981-23a15f1dcc30 61958-1501 HUMAN PRESCRIPTION DRUG Sovaldi SOFOSBUVIR TABLET, FILM COATED ORAL 20131206 NDA NDA204671 Gilead Sciences, Inc. SOFOSBUVIR 400 mg/1 Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC],RNA Replicase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient] N 20181231 61958-1701_0fe9413f-bde7-42d5-b097-1c3b427d8f7b 61958-1701 HUMAN PRESCRIPTION DRUG Zydelig idelalisib TABLET, FILM COATED ORAL 20140723 NDA NDA205858 Gilead Sciences, Inc. IDELALISIB 100 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 61958-1702_0fe9413f-bde7-42d5-b097-1c3b427d8f7b 61958-1702 HUMAN PRESCRIPTION DRUG Zydelig idelalisib TABLET, FILM COATED ORAL 20140723 NDA NDA205858 Gilead Sciences, Inc. IDELALISIB 150 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 61958-1801_b128aec3-bc84-4b28-a4d5-d69fc560a5ca 61958-1801 HUMAN PRESCRIPTION DRUG Harvoni LEDIPASVIR and SOFOSBUVIR TABLET, FILM COATED ORAL 20141010 NDA NDA205834 Gilead Sciences, Inc LEDIPASVIR; SOFOSBUVIR 90; 400 mg/1; mg/1 Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC],RNA Replicase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient] N 20181231 61958-1901_5e3e8414-0eaa-43e3-8ce7-73c9806c33df 61958-1901 HUMAN PRESCRIPTION DRUG Genvoya elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide TABLET ORAL 20151105 NDA NDA207561 Gilead Sciences, Inc. ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 150; 150; 200; 10 mg/1; mg/1; mg/1; mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-2002_a4c9364b-8cec-424e-9129-be14a27fa5ce 61958-2002 HUMAN PRESCRIPTION DRUG DESCOVY emtricitabine and tenofovir alafenamide TABLET ORAL 20160404 NDA NDA208215 Gilead Sciences, Inc. EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 200; 25 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-2101_70ab5e1b-43c8-4a80-a65d-94eb36ff1d59 61958-2101 HUMAN PRESCRIPTION DRUG ODEFSEY emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide TABLET ORAL 20160301 NDA NDA208351 Gilead Sciences, Inc. EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE 200; 25; 25 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [Chemical/Ingredient],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-2201_a86fec5c-d91f-41ac-ac24-a04039a5cf0e 61958-2201 HUMAN PRESCRIPTION DRUG Epclusa Velpatasvir and Sofosbuvir TABLET, FILM COATED ORAL 20160628 NDA NDA208341 Gilead Sciences, Inc. VELPATASVIR; SOFOSBUVIR 100; 400 mg/1; mg/1 Hepatitis C Virus NS5A Inhibitor [EPC],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA],Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC],RNA Replicase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient] N 20181231 61958-2301_5ad06485-fa8d-4233-e053-2a91aa0a0575 61958-2301 HUMAN PRESCRIPTION DRUG VEMLIDY tenofovir alafenamide TABLET ORAL 20161110 NDA NDA208464 Gilead Sciences, Inc. TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 61958-2401_1fb72895-3539-47ce-8b3b-b5170ff167dc 61958-2401 HUMAN PRESCRIPTION DRUG Vosevi SOFOSBUVIR, VELPATASVIR, and VOXILAPREVIR TABLET, FILM COATED ORAL 20170718 NDA NDA209195 Gilead Sciences, Inc. SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR 400; 100; 100 mg/1; mg/1; mg/1 Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC],RNA Replicase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Hepatitis C Virus NS5A Inhibitor [EPC],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA],Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],HCV NS3/4A Protease Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA] N 20181231 61971-065_41a938f9-f98f-4208-a9a2-fd6097df087e 61971-065 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE Isoxsuprine hydrochloride TABLET ORAL 19970919 UNAPPROVED DRUG OTHER Vista Pharmaceuticals, Inc. ISOXSUPRINE HYDROCHLORIDE 20 mg/1 N 20181231 61971-115_a7c5880d-e4ba-45b6-b982-2e0d54f55c1a 61971-115 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20060606 ANDA ANDA076817 Vista Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 61971-120_a7c5880d-e4ba-45b6-b982-2e0d54f55c1a 61971-120 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20060822 ANDA ANDA076817 Vista Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 61979-001_edc56476-093f-47c2-a05c-cfe338f67da6 61979-001 HUMAN OTC DRUG BODY TIME Anti-Aging Day Cream SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20140718 OTC MONOGRAPH NOT FINAL part352 Bela Vida Holdings, LLC dba Body Time OCTINOXATE; AVOBENZONE; OCTISALATE; OXYBENZONE 75; 30; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 61979-002_61717380-a147-364f-e053-2991aa0a6c4d 61979-002 HUMAN OTC DRUG Body Time Sun Broad Spectrum SPF30 Anti-Aging Day Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part352 Bela Vida Holdings, LLC dba Body Time AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 61995-0014_480a0a5e-39e9-1f2e-e054-00144ff88e88 61995-0014 HUMAN OTC DRUG J0830014 Jason Sun Family Sunscreen SPF45 Homosalate, Octyl Salicylate, Octocrylene, Avobenzone LOTION TOPICAL 20170207 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 10; 5; 10; 3 g/100g; g/100g; g/100g; g/100g N 20181231 61995-0015_63a211f8-6285-b387-e053-2991aa0a04cf 61995-0015 HUMAN OTC DRUG Jason Mineral Sunscreen SPF30 Broad Spectrum Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170330 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 14.5; 2 g/100g; g/100g N 20191231 61995-0020_617df26b-699c-5d6c-e053-2a91aa0a045b 61995-0020 HUMAN OTC DRUG J0832014 Jason Sun Sport Sunscreen SPF45 Avobenzone, Homosalate, Octocrylene, Octyl Salicylate LOTION TOPICAL 20171207 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 10; 5; 10; 3 g/100g; g/100g; g/100g; g/100g N 20181231 61995-0022_61fc5ec4-094d-f4c9-e053-2a91aa0aab29 61995-0022 HUMAN OTC DRUG J0832212 Jason Kids Sunscreen SPF45 Homosalate, Octyl Salicylate, Octocrylene, Avobenzone LOTION TOPICAL 20171207 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100g; g/100g; g/100g; g/100g N 20191231 61995-0027_6249ff87-5a88-1451-e053-2a91aa0aeadd 61995-0027 HUMAN OTC DRUG J0832706 Jason Sun Facial Sunscreen SPF20 Homosalate, Octyl Salicylate, Octocrylene, Avobenzone LOTION TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 7.5; 3; 5 g/100g; g/100g; g/100g; g/100g N 20191231 61995-0029_2c13e59a-1215-4fcd-9864-87e0c8b444af 61995-0029 HUMAN OTC DRUG Jason Dandruff Relief Treatment 2 in 1 Zinc Pyrithione SHAMPOO TOPICAL 20120419 OTC MONOGRAPH FINAL part358H The Hain Celestial Group, Inc PYRITHIONE ZINC 1 g/100g E 20171231 61995-0030_62600167-55ef-9170-e053-2a91aa0a982f 61995-0030 HUMAN OTC DRUG J1003005 Jason Dandruff Relief Sulfur, Salicylic Acid SHAMPOO TOPICAL 20171127 OTC MONOGRAPH FINAL part358H The Hain Celestial Group, Inc. SULFUR; SALICYLIC ACID 2.4; 2.2 g/100g; g/100g N 20191231 61995-0101_7d8a9963-9123-44ed-84b3-f8118a7f740f 61995-0101 HUMAN OTC DRUG Jason Powersmile Anticavity ,Whitening Powerful Peppermint Sodium Monofluorophosphate GEL ORAL 20110920 OTC MONOGRAPH FINAL part355 The Hain Celestial Group, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 61995-0102_ff155c43-e5a8-4546-bbfa-2623d21fb634 61995-0102 HUMAN OTC DRUG Jason Nutrismile Anticavity Orange Cinnamon Mint Sodium Monofluorophosphate GEL ORAL 20110920 OTC MONOGRAPH FINAL part355 The Hain Celestial Group, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 61995-0103_4f83da8e-94d5-4760-a037-8286b70846ce 61995-0103 HUMAN OTC DRUG Jason Healthy Mouth Anticavity ,Tartar Control Tea Tree Oil and Cinnamon Sodium Monofluorophosphate GEL ORAL 20110920 OTC MONOGRAPH FINAL part355 The Hain Celestial Group, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 61995-0104_ea161207-146e-4910-8512-475a3135d6b6 61995-0104 HUMAN OTC DRUG Jason Sea Fresh Anticavity Strengthening Deep Sea Spearmint Sodium Monofluorophosphate GEL ORAL 20110920 OTC MONOGRAPH FINAL part355 The Hain Celestial Group, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 61995-0129_624c1961-57e3-79e5-e053-2991aa0aec27 61995-0129 HUMAN OTC DRUG J1002901Jason Dandruff Relief 2in1Treatment Zinc Pyrithione SHAMPOO TOPICAL 20171127 OTC MONOGRAPH FINAL part358H The Hain Celestial Group, Inc. PYRITHIONE ZINC 1 g/100g N 20191231 61995-0201_bc73fb11-75b9-4c9e-afac-e844468cc930 61995-0201 HUMAN OTC DRUG Sunbrellas Sport Sunblock SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide CREAM TOPICAL 20091103 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 10; 10; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-0204_a4c30581-5f39-462a-905e-26f51673d47a 61995-0204 HUMAN OTC DRUG Sunbrellas Kids Sunblock SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091103 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 10; 10; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-0205_171017ae-3da7-4034-a777-e1e980a1a17c 61995-0205 HUMAN OTC DRUG Sunbrellas Family Sunblock SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091103 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 10; 10; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-0209_300341ef-89c6-4232-800e-da3a3ea21c1e 61995-0209 HUMAN OTC DRUG Jason Facial Natural Sunscreen Broad Spectrum SPF20 Homosalate, Octocrylene, Ethylhexyl Salicylate, Titanium Dioxide LOTION TOPICAL 20110811 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTISALATE; TITANIUM DIOXIDE 7.5; 5; 3; 2 g/100g; g/100g; g/100g; g/100g E 20171231 61995-0210_5e1a480f-79cb-46fe-90ae-9f1031ebec33 61995-0210 HUMAN OTC DRUG Sunbrellas Mineral Sunblock SPF 30 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20091103 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 14.5; 2 g/100g; g/100g E 20171231 61995-0212_13623c75-93cd-4ab3-a056-5db8830784c4 61995-0212 HUMAN OTC DRUG Earths Best Mineral Sunscreen Broad Spectrum SPF30 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20111019 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 14.5; 2 g/100g; g/100g E 20171231 61995-0300_1916a20a-1f26-4a63-a381-8241253d1a8c 61995-0300 HUMAN OTC DRUG Jason Pure Natural Sun Family Natural Sunscreen Broad Spectrum SPF45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide LOTION TOPICAL 20110911 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 10; 10; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-0302_7c693996-704a-40f0-804f-313cb3561bef 61995-0302 HUMAN OTC DRUG Jason Dandruff Relief Treatment Sulfur, Salicylic Acid SHAMPOO TOPICAL 20100105 OTC MONOGRAPH FINAL part358H The Hain Celestial Group, Inc SULFUR; SALICYLIC ACID 2; 2 g/100g; g/100g E 20171231 61995-0315_b29685a5-2ed8-495a-b1c9-03ac4f95bb91 61995-0315 HUMAN OTC DRUG Jason Pure Natural Sun Mineral Natural Sunscreen Broad Spectrum SPF30 Zinc Oxide, Titanium Oxide LOTION TOPICAL 20110820 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 14.5; 2 g/100g; g/100g E 20171231 61995-0320_bac82772-0ace-4e0e-a95f-4ea9b35e6a5f 61995-0320 HUMAN OTC DRUG Jason Pure Natural Sun Sport Natural Sunscreen Broad Spectrum SPF45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide LOTION TOPICAL 20110810 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 10; 10; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-0322_9858b698-44e0-4768-8002-d1e9e9eb7b95 61995-0322 HUMAN OTC DRUG Jason Pure Natural Sun Kids Natural Sunscren Broad Spectrum SPF45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide LOTION TOPICAL 20110811 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 10; 10; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-0405_18f6ce5d-f4be-4767-9a54-b86d3ed30a15 61995-0405 HUMAN OTC DRUG Earths Best Diaper Relief Zinc Oxide OINTMENT TOPICAL 20110930 OTC MONOGRAPH FINAL part347 The Hain Celestial Group, Inc ZINC OXIDE 21 g/100g E 20171231 61995-0602_39b4d801-758a-4671-b063-300483ec09a0 61995-0602 HUMAN OTC DRUG Jason Cooling Minerals and Tea Tree Pain Therapy Methyl Salicylate OINTMENT TOPICAL 20110923 OTC MONOGRAPH FINAL part348 The Hain Celestial Group, Inc METHYL SALICYLATE 13.5 g/100g E 20171231 61995-0758_de6c79e0-dfe2-4e13-9edf-0b0c3703a7f4 61995-0758 HUMAN OTC DRUG Earths Best Cold Relief Vapor Camphor, Menthol, Eucalyptus Globulus Leaf Oil OINTMENT TOPICAL 20110913 OTC MONOGRAPH FINAL part341 The Hain Celestial Group, Inc CAMPHOR (NATURAL); MENTHOL; EUCALYPTUS OIL 5.3; 2.8; 1.3 g/100g; g/100g; g/100g E 20171231 61995-0822_0c2dc068-ad7e-6a28-e054-00144ff88e88 61995-0822 HUMAN OTC DRUG Jason Sun Kids Sunscreen Broad Spectrum SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE 10; 5; 7; 3; 7.5; 1 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-0827_0c410785-787c-15ef-e054-00144ff88e88 61995-0827 HUMAN OTC DRUG Jason Sun Facial Sunscreen Broad Spectrum SPF20 Homosalate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20140304 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; TITANIUM DIOXIDE 7.5; 3; 5; 2; 1 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-0830_0c3e0fd3-adc7-5ad1-e054-00144ff8d46c 61995-0830 HUMAN OTC DRUG Jason Sun Family Sunscreen Broad Spectrum SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20140310 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE 10; 5; 7; 3; 7.5; 1 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-0832_0c2b8c34-67b7-3ae9-e054-00144ff8d46c 61995-0832 HUMAN OTC DRUG Jason Sun Sport Sunscreen Broad Spectrum SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20140304 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE 10; 5; 7; 3; 7.5; 1 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-1106_d7a25e70-c31d-4d68-bd26-6e9ba37fc463 61995-1106 HUMAN OTC DRUG Anti Dandruff Salicylic Acid SHAMPOO TOPICAL 20140129 OTC MONOGRAPH FINAL part358H The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/414g E 20171231 61995-1107_6c2a2513-2af4-4673-9212-630670f0c91c 61995-1107 HUMAN OTC DRUG Anti Dandruff Salicylic Acid RINSE TOPICAL 20140117 OTC MONOGRAPH FINAL part358H The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/397g E 20171231 61995-1110_78ffc894-e69c-4445-a32c-d271d7ceb8ed 61995-1110 HUMAN OTC DRUG Avalon Organics Baby Protective Zinc Diaper Balm Zinc Oxide CREAM TOPICAL 20111018 OTC MONOGRAPH FINAL part347 The Hain Celestial Group, Inc ZINC OXIDE 21 g/100g E 20171231 61995-1125_69b7dab0-eaff-434b-9138-995a6d6a5962 61995-1125 HUMAN PRESCRIPTION DRUG AV3712501 Mineral Sunscreen SPF 18 Titanium Dioxide CREAM TOPICAL 20060301 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE 7 g/100g E 20171231 61995-1300_60b6ffdd-f1a6-4654-e053-2991aa0a4360 61995-1300 HUMAN OTC DRUG AV3630000 Avalon Organics Eczema Relief Intensive Colloidal Oatmeal CREAM TOPICAL 20170208 OTC MONOGRAPH FINAL part347 The Hain Celestial Group, Inc. OATMEAL 1.5 g/100g N 20181231 61995-1301_60b5e160-3855-2234-e053-2a91aa0a772d 61995-1301 HUMAN OTC DRUG AV3630100 Avalon Organics Eczema Relief Body Colloidal Oatmeal CREAM TOPICAL 20170208 OTC MONOGRAPH FINAL part347 The Hain Celestial Group, Inc. OATMEAL 1.5 g/100g N 20181231 61995-1302_60a652c8-aaa1-fa53-e053-2a91aa0adf8a 61995-1302 HUMAN OTC DRUG AV3630200 Avalon Organics Eczema Relief Gentle Cleanser Colloidal Oatmeal LOTION TOPICAL 20170208 OTC MONOGRAPH FINAL part347 The Hain Celestial Group, Inc. OATMEAL 1.5 g/100g N 20181231 61995-1320_77fd2284-4b2b-41a0-8dc8-e0fd42d2f00d 61995-1320 HUMAN OTC DRUG Avalon Organics Lavender Luminosity Moisture Plus SPF15 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20111018 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 7.5; 2 g/100g; g/100g E 20171231 61995-1386_92fd8db4-79e5-4506-8ef0-e6cc6c7a0928 61995-1386 HUMAN OTC DRUG Avalon Organics Vitamin C Renewal Moisture Plus SPF15 Zinc Oxide, Titanium Dioxide LOTION TOPICAL 20111018 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 7.5; 2 g/100g; g/100g E 20171231 61995-1392_478159a3-8227-2570-e054-00144ff8d46c 61995-1392 HUMAN OTC DRUG AV453902 Avalon Organics Intense Defense Sheer Moisture SPF10 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20161003 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2.8; 3.6 g/100g; g/100g N 20181231 61995-1805_0318396b-f0d2-41a9-ac55-64f3ba4523ec 61995-1805 HUMAN OTC DRUG Avalon Organics COQ10 Repair Wrinkle Defense Broad Spectrum SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20110615 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 7.5; 2 g/100g; g/100g E 20171231 61995-2007_467bad24-0653-22d3-e054-00144ff8d46c 61995-2007 HUMAN OTC DRUG AL0082706 Alba Botanica HW Sunscreen Green Tea SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butyl Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 10; 5; 10; 3 g/100g; g/100g; g/100g; g/100g N 20181231 61995-2011_62869b5a-e8aa-a7d5-e053-2a91aa0aec70 61995-2011 HUMAN OTC DRUG Alba Botanica HW Sunscreen Green Tea SPF45 Avobenzone,Homosalate, Octocrylene,Octyl Salicylate LOTION TOPICAL 20171226 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 10; 5; 10; 3 g/100g; g/100g; g/100g; g/100g N 20191231 61995-2011_6289bfa9-1732-e564-e053-2a91aa0aa0b7 61995-2011 HUMAN OTC DRUG Alba Botanica HW Sunscreen Green Tea SPF45 Avobenzone,Homosalate, Octocrylene,Octyl Salicylate LOTION TOPICAL 20171226 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 10; 5; 10; 3 g/100g; g/100g; g/100g; g/100g N 20191231 61995-2011_6289bfcd-e944-3d6e-e053-2991aa0aadd2 61995-2011 HUMAN OTC DRUG Alba Botanica HW Sunscreen Green Tea SPF45 Avobenzone,Homosalate, Octocrylene,Octyl Salicylate LOTION TOPICAL 20161226 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 10; 5; 10; 3 g/100g; g/100g; g/100g; g/100g N 20191231 61995-2025_08c86fc6-47a4-288b-e054-00144ff88e88 61995-2025 HUMAN OTC DRUG Alba HW Sunscreen Soothing Aloe Vera SPF30 Homosalate, Octisalate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20140213 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; TITANIUM DIOXIDE 7.5; 5; 7.5; 3; 1 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-2031_08c9a0cf-ee77-483b-e054-00144ff88e88 61995-2031 HUMAN OTC DRUG Alba Even Advanced Sea Moss Moisturizer SPF15 Homosalate, Ethylhexyl Salicylate, Octocrylene, Butyl Methoxydibenzoylmethane LOTION TOPICAL 20140113 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 7.5; 5; 3; 2 g/100g; g/100g; g/100g; g/100g E 20171231 61995-2032_06338be6-bfe0-3c44-e054-00144ff8d46c 61995-2032 HUMAN OTC DRUG Alba Even Advanced Mineral CC Cream Light to Medium SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130725 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 3.5; 4 g/100g; g/100g E 20171231 61995-2037_06aa0fa5-1c2f-485b-e054-00144ff88e88 61995-2037 HUMAN OTC DRUG Alba Body Daily Shade SPF15 Homosalate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane LOTION TOPICAL 20131111 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 7.5; 5; 3; 2 g/100g; g/100g; g/100g; g/100g E 20171231 61995-2037_06fc3869-3fe0-5d2f-e054-00144ff8d46c 61995-2037 HUMAN OTC DRUG Alba Body Daily Shade SPF15 Homosalate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane LOTION TOPICAL 20131111 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 7.5; 5; 3; 2 g/100g; g/100g; g/100g; g/100g E 20171231 61995-2039_079ce9f7-406e-28cd-e054-00144ff8d46c 61995-2039 HUMAN OTC DRUG Alba VE Sunscreen Sport SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20140520 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE 10; 5; 10; 3; 7.5; 1 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-2040_629e2051-2b2c-748e-e053-2a91aa0ae19d 61995-2040 HUMAN OTC DRUG Alba Botanica Mineral Sport FF Sunscreen SPF45 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20180110 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 9 g/100g; g/100g N 20191231 61995-2040_62d61240-444e-4ba4-e053-2991aa0aace7 61995-2040 HUMAN OTC DRUG Alba Botanica Mineral Sport FF Sunscreen SPF45 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 9 g/100g; g/100g N 20191231 61995-2060_61582fe0-9d58-8701-e053-2991aa0aa600 61995-2060 HUMAN OTC DRUG AL0076001 Alba Botanica Acnedote Deep Pore Wash Salicylic Acid LOTION TOPICAL 20171129 OTC MONOGRAPH FINAL part333D The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/100g N 20181231 61995-2081_615afe0d-b544-8efc-e053-2991aa0ab306 61995-2081 HUMAN OTC DRUG AL0078101 Alba Botanica Good and Clean Acne Wash Salicylic Acid LOTION TOPICAL 20171129 OTC MONOGRAPH FINAL part333D The Hain Celestial Group, Inc. SALICYLIC ACID 1 g/100g N 20181231 61995-2082_07da8cea-100b-7195-e054-00144ff8d46c 61995-2082 HUMAN OTC DRUG Alba Hawaiian Sunscreen Green Tea SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butyl Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20131028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE 10; 5; 10; 3; 7.5; 1 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-2083_616b84b8-58c8-2e24-e053-2a91aa0ac110 61995-2083 HUMAN OTC DRUG AL0083103 Alba Hawaiian Dry Coconut Sunscreen SPF15 Octisalate, Octocrylene, Avobenzone OIL TOPICAL 20170714 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. OCTISALATE; OCTOCRYLENE; AVOBENZONE 5; 7.5; 2 g/133g; g/133g; g/133g N 20181231 61995-2085_468dd5f5-0ced-0c29-e054-00144ff88e88 61995-2085 HUMAN OTC DRUG AL0038502 Alba Tropical Fruit Kids Sunscreen SPF40 Homosalate, Octocrylene, Ethylhexyl Salicylate, Avobenzone SPRAY TOPICAL 20160913 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 12; 7; 5; 3 g/100g; g/100g; g/100g; g/100g N 20181231 61995-2088_639fe20a-9837-2d14-e053-2991aa0ab992 61995-2088 HUMAN OTC DRUG Alba Botanica Kids Mineral Sunscreen FF SPF30 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 14.5; 2 g/100g; g/100g N 20191231 61995-2089_638e119f-51c7-59a6-e053-2991aa0aeffa 61995-2089 HUMAN OTC DRUG Alba Botanica Mineral Sunscreen FF SPF30 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 14.5; 2 g/100g; g/100g N 20191231 61995-2089_639e786b-03fc-ac2d-e053-2a91aa0a9d02 61995-2089 HUMAN OTC DRUG Alba Botanica Mineral Sunscreen FF SPF30 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170126 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 14.5; 2 g/100g; g/100g N 20191231 61995-2090_463e8172-8233-21b4-e054-00144ff88e88 61995-2090 HUMAN OTC DRUG AL0039006 Alba Sport Sunscreen Fragrance Free SPF45 Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20161121 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 10; 5; 10; 3 g/100g; g/100g; g/100g; g/100g N 20181231 61995-2091_07d72e69-417a-3268-e054-00144ff88e88 61995-2091 HUMAN OTC DRUG Alba VE Sunscreen SPF30 Fragrance Free Homosalate, Ethylhexyl Salicylate, Octocrylene, Butyl Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; TITANIUM DIOXIDE 7.5; 5; 7.5; 3; 1 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-2093_629a3407-13b5-36f3-e053-2991aa0a6e39 61995-2093 HUMAN OTC DRUG Alba Botanica Pure Lavender Sunscreen SPF45 Avobenzone, Homosalate, Octocrylene, Octyl Salicylate LOTION TOPICAL 20180105 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 10; 5; 10; 3 g/100g; g/100g; g/100g; g/100g N 20191231 61995-2093_629c432d-f41f-4b8e-e053-2991aa0ace74 61995-2093 HUMAN OTC DRUG Alba Botanica Pure Lavender Sunscreen SPF45 Avobenzone, Homosalate, Octocrylene, Octyl Salicylate LOTION TOPICAL 20170809 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 10; 5; 10; 3 g/100g; g/100g; g/100g; g/100g N 20191231 61995-2095_08b403aa-fc48-2ac7-e054-00144ff8d46c 61995-2095 HUMAN OTC DRUG Alba VE Facial Sunscreen SPF30 Homosalate, Octisalate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide LOTION TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; TITANIUM DIOXIDE 7.5; 5; 7.5; 3; 1 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-2102_d013384d-aefb-4661-ab37-0f1860d218d0 61995-2102 HUMAN OTC DRUG Alba HawaiianDry Sunscreen SPF15 Homosalate, Octisalate, Octocrylene, Avobenzone OIL TOPICAL 20140114 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 10; 5; 3; 2 g/133g; g/133g; g/133g; g/133g E 20171231 61995-2312_689b437a-207a-469b-9d1b-93279bce233d 61995-2312 HUMAN OTC DRUG Alba Botanica Natural Even Advanced Sea Moss Moisturizer SPF15 Homosalate, Octocrylene, Ethylhexyl Salicylate LOTION TOPICAL 20110602 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTISALATE 7.5; 5; 5 g/100g; g/100g; g/100g E 20171231 61995-2328_0608ed7f-47f8-4c19-e054-00144ff88e88 61995-2328 HUMAN OTC DRUG Alba Even Advanced Mineral CC Cream Fair to Light SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20130725 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 3.5; 4 g/100g; g/100g E 20171231 61995-2329_83efe10f-ee4b-42f7-a57b-1c8ac81e549e 61995-2329 HUMAN OTC DRUG Alba Botanica UN-petroleum Tangerine SPF18 Lip Balm Ethylhexyl Dimethyl PABA, Benzophenone-3 STICK TOPICAL 20111102 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. PADIMATE O; OXYBENZONE 7.5; 5 g/100g; g/100g E 20171231 61995-2371_632dbe73-b92d-4b92-b892-1b694451bbbb 61995-2371 HUMAN OTC DRUG Alba Botanica Natural Very Emollient Daily Shade SPF15 Homosalate, Ethylhexyl Salicylate, Octocrylene LOTION TOPICAL 20111018 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE 7.5; 5; 3 g/100g; g/100g; g/100g E 20171231 61995-2378_456017cd-3962-3263-e054-00144ff8d46c 61995-2378 HUMAN OTC DRUG AL00378 Alba Cool Sport Sunscreen SPF50 Avobenzone, Homosalate, Octocrylene, Octyl Salicylate SPRAY TOPICAL 20161114 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE 8; 5; 3; 15 g/100g; g/100g; g/100g; g/100g N 20181231 61995-2381_270c273b-7099-42db-e054-00144ff8d46c 61995-2381 HUMAN OTC DRUG AL0038100 Alba VE Sunscreen Fragrance Free SPF50 Homosalate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane SPRAY TOPICAL 20150203 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE 8; 5; 3; 15 g/100g; g/100g; g/100g; g/100g N 20181231 61995-2382_2669183c-7a5f-037e-e054-00144ff88e88 61995-2382 HUMAN OTC DRUG AL0038200 Alba VE Sunscreen Kids SPF50 Homosalate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane SPRAY TOPICAL 20150203 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE 8; 5; 3; 15 g/100g; g/100g; g/100g; g/100g N 20181231 61995-2383_13a42682-9ef2-4aba-93b5-76f19b394c9d 61995-2383 HUMAN OTC DRUG Alba Botanica Natural Very Emollient Sunscreen Sport Spray SPF40 Homosalate, Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane LOTION TOPICAL 20111229 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 12; 7.5; 7; 5; 3 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-2384_614301bd-f736-5ede-e053-2991aa0ae3be 61995-2384 HUMAN OTC DRUG AL0038400 Alba Botanica Fast Fix Sun SPF30 Octocrylene, Octyl Salicylate, Zinc Oxide STICK TOPICAL 20171226 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; OCTISALATE; OCTOCRYLENE 20; 5; 10 g/100g; g/100g; g/100g N 20181231 61995-2385_76bcd7c2-396b-4fa2-a5bd-faf5fe49dcb8 61995-2385 HUMAN OTC DRUG Alba Botanica Natural Very Emollient Sunscreen Kids SPF40 Homosalate, Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane SPRAY TOPICAL 20111229 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 12; 7.5; 7; 5; 3 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-2387_f387c938-12d9-48ce-9ae9-4589d59a2cc9 61995-2387 HUMAN OTC DRUG Alba Sunblock Facial SPF 20 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 8; 1 g/100g; g/100g E 20171231 61995-2388_200300f5-b280-46ec-a9ea-a7ca55d8d3e0 61995-2388 HUMAN OTC DRUG Alba Kids Mineral Sunblock SPF 30 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 14.5; 2 g/100g; g/100g E 20171231 61995-2389_b0c449e5-00c7-4070-a171-17e678b63158 61995-2389 HUMAN OTC DRUG Alba Sunblock Mineral FF SPF 30 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 14.5; 2 g/100g; g/100g E 20171231 61995-2390_a0748931-d37a-49dd-92ad-631ddc22260b 61995-2390 HUMAN OTC DRUG Alba Sunblock Natural Sport SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 10; 10; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-2391_5966a1a7-67e7-4097-87a9-9bb64263254f 61995-2391 HUMAN OTC DRUG Alba Sunblock Natural FF SPF 30 Homosalate, Octocrylene, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTISALATE; TITANIUM DIOXIDE 7.5; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g E 20171231 61995-2392_562ba25c-6570-491b-94e5-f8a0a1d55ecd 61995-2392 HUMAN PRESCRIPTION DRUG Alba Sunblock Mineral Aloe Vanilla SPF 30 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 12; 1 g/100g; g/100g Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] E 20171231 61995-2393_cb88c9aa-1fd4-4e63-aafc-ebdcdea3679e 61995-2393 HUMAN OTC DRUG Alba Sunblock Natural Lavender SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 10; 10; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-2394_c330b16e-974e-4edc-8f12-3a4237223b21 61995-2394 HUMAN OTC DRUG Alba Lip Care Sunblock SPF 25 Octocrylene, Ethylhexyl Methoxycinnamate, Zinc Oxide, Ethylhexyl Salicilate CREAM TOPICAL 20091027 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. OCTOCRYLENE; OCTINOXATE; ZINC OXIDE; OCTISALATE 10; 7.5; 3.9; 1 g/100g; g/100g; g/100g; g/100g E 20171231 61995-2395_0c677cd4-6b66-4b56-9a3c-303349b7e69d 61995-2395 HUMAN OTC DRUG Alba Sunblock Natural Facial SPF 30 Homosalate, Octocrylene, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTISALATE; TITANIUM DIOXIDE 7.5; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g E 20171231 61995-2399_83504559-36b1-4acf-9ac9-f192e6939bca 61995-2399 HUMAN OTC DRUG Alba Sunblock Natural Kids SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091228 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 10; 10; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-2400_05680826-a5ef-6685-e054-00144ff88e88 61995-2400 HUMAN OTC DRUG Alba Mineral Sunscreen Sport SPF45 Broad Spectrum Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20131227 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 9 g/100g; g/100g E 20171231 61995-2404_2beba8e3-9c3b-1107-e054-00144ff8d46c 61995-2404 HUMAN OTC DRUG AL0040400 Alba VE Mineral Sunscreen SPF35 Zinc Oxide, Titanium Dioxide SPRAY TOPICAL 20160113 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 6.4; 6.8 g/100g; g/100g N 20181231 61995-2405_2c23f647-d8af-41e0-e054-00144ff8d46c 61995-2405 HUMAN OTC DRUG AL0040500 Alba VE Mineral Sunscreen Herbal Fresh SPF35 Zinc Oxide, Titanium Dioxide SPRAY TOPICAL 20160113 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 6.4; 6.8 g/100g; g/100g N 20181231 61995-2406_29a52bdc-ff3c-5cca-e054-00144ff88e88 61995-2406 HUMAN OTC DRUG AL0040600 Alba Cooling Aloe Burn Relief Menthol, Allantoin SPRAY TOPICAL 20160113 OTC MONOGRAPH FINAL part347 The Hain Celestial Group, Inc ALLANTOIN; MENTHOL .5; .5 g/100g; g/100g N 20181231 61995-2436_60672feb-1420-651e-e053-2a91aa0af41d 61995-2436 HUMAN OTC DRUG AL0043600 Alba Botanica VE Herbal Healing Body Colloidal Oatmeal LOTION TOPICAL 20170912 OTC MONOGRAPH FINAL part347 The Hain Celestial Group, Inc. OATMEAL .4 g/100g N 20181231 61995-2437_60cda526-4b45-00a3-e053-2a91aa0abac0 61995-2437 HUMAN OTC DRUG AL0043700 Alba Botanica Baby Mineral Sunscreen SPF50 Zinc Oxide LOTION TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE 17 g/100g N 20181231 61995-2438_60f3624e-1723-10d1-e053-2a91aa0a6f35 61995-2438 HUMAN OTC DRUG AL0043800 Alba Botanica Sheer Shield Sunscreen FF SPF50 Avobenzone, Octocrylene, Octyl Salicylate LOTION TOPICAL 20171213 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. OCTISALATE; OCTOCRYLENE; AVOBENZONE 5; 10; 3 g/100g; g/100g; g/100g N 20181231 61995-2500_03a98f64-9563-66c3-e054-00144ff8d46c 61995-2500 HUMAN OTC DRUG Alba Mineral Terra Tint SPF15 Blaze Zinc Oxide CREAM TOPICAL 20130806 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE 5.5 g/100g E 20171231 61995-2515_044f0375-feda-502a-e054-00144ff88e88 61995-2515 HUMAN OTC DRUG Alba Mineral Terr Tint SPF15 Bloom Zinc Oxide CREAM TOPICAL 20130816 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE 5.5 g/100g E 20171231 61995-2535_04f0d499-26fb-1d4c-e054-00144ff88e88 61995-2535 HUMAN OTC DRUG Alba Mineral Terra Tint SPF15 Garnet Zinc Oxide CREAM TOPICAL 20130816 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. ZINC OXIDE 5.5 g/100g E 20171231 61995-2760_b0cd0065-30a1-49e1-b3f4-7c9832b91825 61995-2760 HUMAN OTC DRUG Alba Natural Acnedote Wash Salicylic Acid LOTION TOPICAL 20100121 OTC MONOGRAPH FINAL part333 The Hain Celestial Group, Inc. SALICYLIC ACID 2 mL/100mL E 20171231 61995-2761_ef83a032-3c67-4fb1-ad10-94f90e5acbe5 61995-2761 HUMAN OTC DRUG Alba Natural Acnedote Face Body Scrub Salicylic Acid CREAM TOPICAL 20100121 OTC MONOGRAPH FINAL part333 The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/100g E 20171231 61995-2762_55c594f6-52c0-42d9-8b0c-9349dc3b3f24 61995-2762 HUMAN OTC DRUG Alba Natural Acnedote Salicylic Acid LOTION TOPICAL 20100218 OTC MONOGRAPH FINAL part333 The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/100g E 20171231 61995-2763_ea077ef0-b2ff-47be-94d2-e8bb9e346539 61995-2763 HUMAN OTC DRUG Alba Natural Acnedote Astringent Salicylic Acid LOTION TOPICAL 20100121 OTC MONOGRAPH FINAL part333 The Hain Celestial Group, Inc. SALICYLIC ACID 2 mL/100mL E 20171231 61995-2764_0784dc3a-2d53-2cee-e054-00144ff8d46c 61995-2764 HUMAN OTC DRUG Alba Acnedote Invisible Treatment Salicylic Acid LOTION TOPICAL 20131001 OTC MONOGRAPH FINAL part333D The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/100g E 20171231 61995-2765_082758ac-3e51-11fd-e054-00144ff88e88 61995-2765 HUMAN OTC DRUG Alba Acnedote Clean Treat Towelette Salicylic Acid CLOTH TOPICAL 20131126 OTC MONOGRAPH FINAL part333D The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/301 E 20171231 61995-2766_0863929c-3a2a-576c-e054-00144ff88e88 61995-2766 HUMAN OTC DRUG Alba Acnedote Clean Treat Cleansing Towelette Salicylic Acid CLOTH TOPICAL 20131126 OTC MONOGRAPH FINAL part333D The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/101 E 20171231 61995-2769_5fc9efa3-fa73-da28-e053-2a91aa0a8f79 61995-2769 HUMAN OTC DRUG AL0076900 Alba Botanica AcnedoteClearing Peel Salicylic Acid GEL TOPICAL 20170606 OTC MONOGRAPH FINAL part333D The Hain Celestial Group, Inc. SALICYLIC ACID 1 g/100g N 20181231 61995-2781_07364a19-a71c-23c9-e054-00144ff88e88 61995-2781 HUMAN OTC DRUG Alba Good and Clean Gentle Acne Wash Salicylic Acid LOTION TOPICAL 20130307 OTC MONOGRAPH FINAL part333D The Hain Celestial Group, Inc. SALICYLIC ACID 1 g/100g E 20171231 61995-2789_06840628-9ec3-04f7-e054-00144ff88e88 61995-2789 HUMAN OTC DRUG Alba Good and Healthy Moisturizer SPF15 Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20140127 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. TITANIUM DIOXIDE; ZINC OXIDE 3.7; 4.8 g/100g; g/100g E 20171231 61995-2825_bc29f36b-aab4-4ac8-bded-15e7bc853348 61995-2825 HUMAN OTC DRUG Alba Hawaiian Aloe Vera Sunblock SPF 30 Homosalate, Octocrylene, Ethylhexyl Salicylate, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTISALATE; TITANIUM DIOXIDE 7.5; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g E 20171231 61995-2827_d95663fa-e39b-4bf7-9dd1-37f9854187cc 61995-2827 HUMAN OTC DRUG Alba Hawaiian Green Tea Sunblock SPF 45 Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide CREAM TOPICAL 20091028 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 10; 10; 7.5; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 61995-2831_85846e1f-75fa-47bd-9604-ee15b6e95723 61995-2831 HUMAN OTC DRUG Alba Hawaiian Coconut Siscreen SPF 15 Homosalate, Ethylhexyl Salicylate, Octocrylene CREAM TOPICAL 20091117 OTC MONOGRAPH NOT FINAL part352 The Hain Celestial Group, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE 10; 5; 3 g/100g; g/100g; g/100g E 20171231 61995-2843_270d0dce-02cd-5453-e054-00144ff8d46c 61995-2843 HUMAN OTC DRUG AL0038100 Alba HW Sunscreen Coconut Milk SPF50 Homosalate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane SPRAY TOPICAL 20150203 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE 8; 5; 3; 15 g/100g; g/100g; g/100g; g/100g N 20181231 61995-2921_30695b6c-a104-441c-bc7b-39b6e86fcfc2 61995-2921 HUMAN OTC DRUG Alba Botanica UN-petroleum Vanilla SPF18 Lip Balm Ethylhexyl Dimethyl PABA, Benzophenone-3 STICK TOPICAL 20111102 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. PADIMATE O; OXYBENZONE 7.5; 5 g/100g; g/100g E 20171231 61995-2923_8971c6ba-f016-47cb-bb7b-1efed0861686 61995-2923 HUMAN OTC DRUG Alba Botanica UN-petroleum Cherry SPF18 Lip Balm Ethylhexyl Dimethyl PABA, Benzophenone-3 STICK TOPICAL 20111102 OTC MONOGRAPH FINAL part352 The Hain Celestial Group, Inc. PADIMATE O; OXYBENZONE 7.5; 5 g/100g; g/100g E 20171231 61995-2933_47958c21-9740-7384-e054-00144ff8d46c 61995-2933 HUMAN OTC DRUG AL00933 Alba Botanica Fast Fix Papaya Anti Acne Sheet Mask Salicylic Acid CLOTH TOPICAL 20160816 OTC MONOGRAPH FINAL part333D The Hain Celestial Group, Inc. SALICYLIC ACID 2 g/1 N 20181231 61995-4704_276f36c4-8f04-6eef-e054-00144ff88e88 61995-4704 HUMAN OTC DRUG Earth Best Diaper Relief Zinc Oxide OINTMENT TOPICAL 20110824 OTC MONOGRAPH FINAL part347 The Hain Celestial Group, Inc ZINC OXIDE 19 g/100g N 20181231 62000-321_918af033-f8ca-4173-b887-f1c9ef70fa98 62000-321 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Medical Home Care, Inc OXYGEN 99.6 L/100L E 20171231 62001-0318_0e9551ee-2843-451b-9c48-5cebdfcb75c8 62001-0318 HUMAN OTC DRUG Medic Ice Menthol GEL TOPICAL 20040824 OTC MONOGRAPH NOT FINAL part348 Straight Arrow Products, Inc. MENTHOL .07 g/g E 20171231 62001-0319_0f2ea8af-99e9-4d7f-a023-f2018510e3d1 62001-0319 HUMAN OTC DRUG Mane n Tail Daily Control Anti-Dandruff Pyrithione Zinc SHAMPOO, SUSPENSION TOPICAL 20080420 OTC MONOGRAPH FINAL part358H Straight Arrow Products, Inc. PYRITHIONE ZINC .01 g/g E 20171231 62001-0320_33295d81-7b20-4817-840b-11795cd549ec 62001-0320 HUMAN OTC DRUG The Original Mane n Tail Daily Control Anti Dandruff Conditioner Pyrithione Zinc RINSE TOPICAL 20080420 OTC MONOGRAPH FINAL part358H Straight Arrow Products, Inc. PYRITHIONE ZINC .005 g/g N 20181231 62001-0321_7f5b2298-25cc-4c5f-bf05-1ffe51b3990d 62001-0321 HUMAN OTC DRUG Mane n Tail Daily Control 2 in 1 Anti Dandruff Shampoo Conditioner Pyrithione Zinc SHAMPOO TOPICAL 20090320 OTC MONOGRAPH FINAL part358H Straight Arrow Products, Inc. PYRITHIONE ZINC .01 g/g E 20171231 62001-0330_bfb270cb-026a-4b3e-995e-bb4b8b331804 62001-0330 HUMAN OTC DRUG The Original Mane n Tail Daily Control 2 in 1 Anti Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20090320 OTC MONOGRAPH FINAL part358H Straight Arrow Products Inc PYRITHIONE ZINC .01 g/.01g N 20181231 62001-0331_ebb569a3-b866-4b63-8151-4600c6fdab4f 62001-0331 HUMAN OTC DRUG The Original Mane n Tail Daily Control Anti Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20080420 OTC MONOGRAPH FINAL part358H Straight Arrow Products Inc PYRITHIONE ZINC .01 g/.01g E 20171231 62001-0332_66b0231f-af09-4d2b-bc02-2f8dff0bdc91 62001-0332 HUMAN OTC DRUG The Original Mane n Tail Daily Control Anti Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20080420 OTC MONOGRAPH FINAL part358H Straight Arrow Products Inc PYRITHIONE ZINC .01 g/.01g N 20181231 62003-001_0935f36f-52db-42ec-ba9d-d98874cff723 62003-001 HUMAN OTC DRUG Coldaid menthol GRANULE, FOR SOLUTION ORAL 20101201 OTC MONOGRAPH NOT FINAL part356 PRINCE OF PEACE ENTERPRISES INC. MENTHOL 490 mg/5g E 20171231 62003-002_7dc7752a-ef40-40c3-8571-c8b1d6162469 62003-002 HUMAN OTC DRUG Fluaid menthol GRANULE, FOR SOLUTION ORAL 20101201 OTC MONOGRAPH NOT FINAL part356 PRINCE OF PEACE ENTERPRISES INC. MENTHOL 270 mg/6g E 20171231 62003-422_02fce045-a09e-4f85-975b-09bb332a622c 62003-422 HUMAN OTC DRUG Tiger Balm Arthritis Rub Camphor (Synthetic) and Menthol CREAM TOPICAL 20020610 OTC MONOGRAPH NOT FINAL part348 Prince of Peace Enterprises, Inc. CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM 110; 110 mg/mL; mg/mL N 20181231 62003-888_31f96d1d-f2a0-491c-80a5-f527885c0c4b 62003-888 HUMAN OTC DRUG Han Honey Loquat Syrup menthol SYRUP ORAL 20140501 OTC MONOGRAPH NOT FINAL part356 PRINCE OF PEACE ENTERPRISES INC. MENTHOL .1 g/100mL E 20171231 62007-001_7eab8df6-d52e-4c6d-b41b-ed90d498e3fa 62007-001 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL BANANA BERRY FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-002_cb71c401-2c2a-478f-9ea5-ed8e78ba09a8 62007-002 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE BAZOOKA BUBBLEGUM FLUORIDE TREATMENT GEL TOPICAL 20171107 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-003_5e842328-8378-d83f-e053-2991aa0a58be 62007-003 HUMAN PRESCRIPTION DRUG PCXX WILD CHERRY APF G Sodium Fluoride GEL DENTAL; TOPICAL 20171117 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mL N 20181231 62007-004_1d9fec6c-0db4-40c6-9269-5e7b89039b30 62007-004 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL MOCHA CAPPUCCINO FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-005_527e74ac-aef1-4399-b599-31d8073aaa69 62007-005 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL MARSHMALLOW FLOAT FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-006_b2a2cf43-894c-4684-8389-b643e7e6cc84 62007-006 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL CREME DE MENTHE FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-008_5e8515d8-d314-5364-e053-2991aa0aea8b 62007-008 HUMAN PRESCRIPTION DRUG PCXX PINA COLADA APF G Sodium Fluoride GEL DENTAL; TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mL N 20181231 62007-009_e17e9fcc-df38-4320-9939-10898ec6d834 62007-009 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL RASPBERRY BLAST FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-010_1acc36ad-588d-4284-a299-88cf4cb6fa5f 62007-010 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL STRAWBERRY BLAST FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-011_077f5f48-e70c-4e83-ac05-59c35808dd4a 62007-011 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL VANILLA ORANGE FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-012_7395cc0b-93d5-4933-a102-75fdc7071be5 62007-012 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL GRAPE EXPLOSION FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-013_5a8301a7-8b01-449f-bfd5-5ad1c95b8dfa 62007-013 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL WATERMELON SPLASH FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-014_3ebf022d-ebc8-485a-8199-7e085f9f16aa 62007-014 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL COOL PEPPERMINT FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-015_b52d0568-d6dc-4f22-bac1-43acd440f54a 62007-015 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL LUSCIOUS LIME FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-020_dd5d39cf-36bd-4492-b725-f1aaf3503cc7 62007-020 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL CREME DE MENTHE FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg N 20181231 62007-022_885c8518-d122-467b-b907-de2479a46db2 62007-022 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL RASPBERRY BLAST FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg N 20181231 62007-023_5929cf3f-28ec-4528-b375-68e19357e926 62007-023 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL VANILLA ORANGE FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg N 20181231 62007-024_047d7981-a94f-4b01-a8c2-46d76b96aede 62007-024 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL PINA COLADA FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg N 20181231 62007-025_2ff95f0b-eeb9-4783-b87d-24cb21c21758 62007-025 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL COOL PEPPERMINT FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg N 20181231 62007-026_85133b26-58d9-4d45-8e88-a99e0225265a 62007-026 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL RASPBERRY BLAST FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg N 20181231 62007-027_9ae05d75-3cc0-4e85-845c-4c5723ad035a 62007-027 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL WATERMELON SPLASH FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg N 20181231 62007-028_f6bc4581-ef29-4ffe-ba91-be1b92f553ab 62007-028 HUMAN PRESCRIPTION DRUG PCXX ONE MINTE GEL ROOTBEER FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-029_2a22def9-9017-45d0-865e-d636646bdf12 62007-029 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL GEL MOCHA CAPUCCINO FLUORIDE TREATMENT GEL TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg N 20181231 62007-030_5f4fd5bf-445f-d0fd-e053-2a91aa0ac8e4 62007-030 HUMAN PRESCRIPTION DRUG PCXX ANTICARIES NO FLAVOR NE G Sodium Fluoride GEL DENTAL; TOPICAL 20171201 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 11.1 mg/mL N 20181231 62007-035_12f32bf2-305b-44ac-9f74-23a08d852080 62007-035 HUMAN PRESCRIPTION DRUG PCXX Home Treatment 1.1 SODIUM FLUORIDE GEL TOPICAL 20150216 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 11 mg/mg N 20181231 62007-041_175e37cc-0887-428a-ba3a-7718fda22444 62007-041 HUMAN PRESCRIPTION DRUG PCXX REMIN 0.4 SODIUM FLUORIDE GEL TOPICAL 20150216 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg N 20181231 62007-051_5e81196f-7d2e-1a6b-e053-2a91aa0a4dbb 62007-051 HUMAN PRESCRIPTION DRUG PCXX VANILLA ORANGE ONE MINUTE FM Sodium Fluoride AEROSOL, FOAM TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .0272 g/g N 20181231 62007-052_5e835144-454e-3675-e053-2991aa0adb90 62007-052 HUMAN PRESCRIPTION DRUG PCXX BUBBLEGUM APF F Sodium Fluoride AEROSOL, FOAM TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .0272 g/g N 20181231 62007-053_5e85033c-35d5-672b-e053-2a91aa0a3a60 62007-053 HUMAN PRESCRIPTION DRUG PCXX GRAPE APF F Sodium Fluoride AEROSOL, FOAM TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .0272 g/g N 20181231 62007-054_90e7dab2-96ab-4cc2-a2f7-89bf11fcd96c 62007-054 HUMAN PRESCRIPTION DRUG PCXX ONE MINUTE COOL PEPPERMINT SODIUM FLUORIDE GEL TOPICAL 20150203 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .02 mg/mL N 20181231 62007-055_5e85c373-568d-7755-e053-2991aa0aa039 62007-055 HUMAN PRESCRIPTION DRUG PCXX STRAWBERRY APF F Sodium Fluoride AEROSOL, FOAM DENTAL; TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .0272 g/g N 20181231 62007-056_5e862383-e1c5-7677-e053-2a91aa0ac59e 62007-056 HUMAN PRESCRIPTION DRUG PCXX CAPPUCCINO APF F Sodium Fluoride AEROSOL, FOAM DENTAL; TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .0272 g/g N 20181231 62007-057_5e862eaa-2b49-760b-e053-2a91aa0ae923 62007-057 HUMAN PRESCRIPTION DRUG PCXX RASPBERRY APF F Sodium Fluoride AEROSOL, FOAM DENTAL; TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .0272 g/g N 20181231 62007-058_5e862e58-6f3a-0f10-e053-2a91aa0ae6b7 62007-058 HUMAN PRESCRIPTION DRUG PCXX CHERRY APF F Sodium Fluoride AEROSOL, FOAM DENTAL; TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .0272 g/g N 20181231 62007-059_5e8680eb-43b4-7403-e053-2a91aa0adcec 62007-059 HUMAN PRESCRIPTION DRUG PCXX PEPPERMINT APF F Sodium Fluoride AEROSOL, FOAM DENTAL; TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .0272 g/g N 20181231 62007-060_5e8680eb-43c1-7403-e053-2a91aa0adcec 62007-060 HUMAN PRESCRIPTION DRUG PCXX ROOTBEER APF F Sodium Fluoride AEROSOL, FOAM DENTAL; TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .0272 g/g N 20181231 62007-101_5e87ca30-ebc3-3498-e053-2991aa0abac9 62007-101 HUMAN PRESCRIPTION DRUG PCXX VANILLA ORANGE NEUTRAL F Sodium Fluoride AEROSOL, FOAM DENTAL; TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .02 g/g N 20181231 62007-102_5e870d90-bb29-0d42-e053-2a91aa0ab77f 62007-102 HUMAN PRESCRIPTION DRUG PCXX PEPPERMINT NEUTRAL F Sodium Fluoride AEROSOL, FOAM DENTAL; TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .02 g/g N 20181231 62007-103_5e86783c-4153-5f46-e053-2991aa0abb3b 62007-103 HUMAN PRESCRIPTION DRUG PCXX STRAWBERRY NEUTRAL F Sodium Fluoride AEROSOL, FOAM DENTAL; TOPICAL 20171121 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .02 g/g N 20181231 62007-104_4a4eba66-89c2-4e49-86a2-cfb90be342bd 62007-104 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL FOAM BAZOOKA BUBBLEGUM FLUORIDE TREATMENT AEROSOL, FOAM TOPICAL 20140521 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg N 20181231 62007-105_db6a3378-8e87-43ad-8c82-8a0a985e3b5e 62007-105 HUMAN PRESCRIPTION DRUG PCxx SODIUM FLUORIDE AEROSOL, FOAM DENTAL 20121212 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 2.5 g/125g N 20181231 62007-126_5e398d9c-8e6f-6664-e053-2a91aa0ac003 62007-126 HUMAN PRESCRIPTION DRUG PCXX BUGGLEGUM NEUTRAL GL Sodium Fluoride GEL TOPICAL 20171117 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/g N 20181231 62007-210_3e601d61-9ee7-41e9-be41-026389890ac9 62007-210 HUMAN PRESCRIPTION DRUG NEUTRAL RINSE SODIUM FLUORIDE LIQUID TOPICAL 20110901 OTC MONOGRAPH FINAL part355 Ross Healthcare, Inc. SODIUM FLUORIDE 2 mL/100mL N 20181231 62007-211_9f1bc298-5127-4834-b18f-11944302b7a1 62007-211 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL RNS STRAWBERRY FLUORIDE TREATMENT LIQUID TOPICAL 20150101 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mg N 20181231 62007-212_a03a33b3-1104-4ff7-bc63-19fbd1410e8d 62007-212 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL RNS GRAPE FLUORIDE TREATMENT RINSE TOPICAL 20150417 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 2 mg/mL N 20181231 62007-213_62e56357-1cbf-475b-86e8-16216ffc0bc0 62007-213 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL RMS BUBBLEGUM FLUORIDE TREATMENT RINSE TOPICAL 20150420 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 20 mg/mL N 20181231 62007-214_39b4a479-c69d-4215-acc4-496b989a92eb 62007-214 HUMAN PRESCRIPTION DRUG PCXX NEUTRAL RNS WATERMELON FLUORIDE TREATMENT RINSE TOPICAL 20150417 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 2 mg/g N 20181231 62007-270_249014b9-3461-4eb8-a2ef-2375d8d7ba05 62007-270 HUMAN PRESCRIPTION DRUG PCXX MINUTE FM LIME SODIUM FLUORIDE AEROSOL, FOAM TOPICAL 20150203 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE .0272 mg/g N 20181231 62007-301_c5515c96-c8ac-4fe1-9fd8-3a0ada68b1b9 62007-301 HUMAN PRESCRIPTION DRUG PCXX 1.64 STANNOUS RNS MINT FLUORIDE TREATMENT LIQUID TOPICAL 20150101 UNAPPROVED DRUG OTHER Ross Healthcare Inc. STANNOUS FLUORIDE 16 1/mg N 20181231 62007-302_8afdf7b5-833a-4cab-964c-497bc94e674a 62007-302 HUMAN PRESCRIPTION DRUG PCXX 1.64 STANNOUS RNSSTRAWBERRY FLUORIDE TREATMENT LIQUID TOPICAL 20150101 UNAPPROVED DRUG OTHER Ross Healthcare Inc. STANNOUS FLUORIDE 16 1/mg N 20181231 62007-303_5ebfbeb6-d213-51dd-e053-2991aa0afa8d 62007-303 HUMAN PRESCRIPTION DRUG PCXX SNF RNS GRAPE Sodium Fluoride RINSE DENTAL; TOPICAL 20171124 UNAPPROVED DRUG OTHER Ross Healthcare Inc. STANNOUS FLUORIDE 16.4 mg/mL N 20181231 62007-311_a3d0a044-7e31-4b3a-b967-707b618d3819 62007-311 HUMAN PRESCRIPTION DRUG PCXX APF RNS MINT FLUORIDE TREATMENT LIQUID TOPICAL 20150202 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-312_01437cff-0ba5-4ba1-814b-2db5b751ff8d 62007-312 HUMAN PRESCRIPTION DRUG PCXX APF RNS STRAWBERRY FLUORIDE TREATMENT LIQUID TOPICAL 20150202 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mg N 20181231 62007-316_5efa0e4c-a173-297c-e053-2991aa0a3a61 62007-316 HUMAN PRESCRIPTION DRUG PCXX APF RNS GRAPE Sodium Fluoride RINSE DENTAL; TOPICAL 20171124 UNAPPROVED DRUG OTHER Ross Healthcare Inc. SODIUM FLUORIDE 27.2 mg/mL N 20181231 62007-400_5e95fcb1-0e78-b35e-e053-2a91aa0a20a7 62007-400 HUMAN OTC DRUG PCxx NaF RNS Mint SODIUM FLUOIRDE RINSE DENTAL; TOPICAL 20171122 OTC MONOGRAPH FINAL part355 Ross Healthcare Inc. SODIUM FLUORIDE .5 mg/mL N 20181231 62007-700_5eaaff39-7958-4006-e053-2a91aa0aa4b6 62007-700 HUMAN OTC DRUG GoGlama NaF RNS Mint SODIUM FLUOIRDE RINSE DENTAL; TOPICAL 20171122 OTC MONOGRAPH FINAL part355 Ross Healthcare Inc. SODIUM FLUORIDE .5 mg/mL N 20181231 62011-0001_8f51e3b2-cb8b-4d92-8d14-6d02ea8d1a8d 62011-0001 HUMAN OTC DRUG Health Mart infants pain and fever Acetaminophen SUSPENSION ORAL 20111213 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL N 20181231 62011-0002_64224a7e-9033-4558-9fcb-d86935c10ba5 62011-0002 HUMAN OTC DRUG health mart pain and fever Acetaminophen SUSPENSION ORAL 20111122 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL N 20191231 62011-0003_78aa44ac-3dce-4a03-a2de-a59f47a99b40 62011-0003 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20121215 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 N 20181231 62011-0004_9cac0a6f-7a31-4eea-b745-0c818a71a474 62011-0004 HUMAN OTC DRUG health mart ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20111121 ANDA ANDA075217 McKesson IBUPROFEN 50 mg/1.25mL N 20181231 62011-0005_ca2b6abe-a85d-43f9-b295-e94075c120dc 62011-0005 HUMAN OTC DRUG Health Mart Stay Awake Caffeine TABLET ORAL 20111121 OTC MONOGRAPH FINAL part340 McKesson CAFFEINE 200 mg/1 N 20181231 62011-0006_62f2dee1-68cc-4200-9c72-6eec4371a7d2 62011-0006 HUMAN OTC DRUG Health Mart Maximum Strength Sleep Aid DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20120406 OTC MONOGRAPH FINAL part338 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 62011-0010_962849e5-9127-4cda-b7e8-70c188bdd3e2 62011-0010 HUMAN OTC DRUG health mart childrens ibuprofen Ibuprofen SUSPENSION ORAL 20111129 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL N 20181231 62011-0011_5c17ff84-9e33-43fb-b5f1-30def0a60406 62011-0011 HUMAN OTC DRUG health mart ibuprofen Ibuprofen SUSPENSION ORAL 20111121 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL N 20181231 62011-0012_d3834337-efd8-4a0b-8df1-97651c5da43a 62011-0012 HUMAN OTC DRUG health mart ibuprofen ibuprofen SUSPENSION ORAL 20111121 ANDA ANDA075217 McKesson IBUPROFEN 50 mg/1.25mL N 20181231 62011-0014_0ef91f36-6ca0-42d7-8f1e-27ee330ce832 62011-0014 HUMAN OTC DRUG health mart ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20111121 ANDA ANDA072096 McKesson IBUPROFEN 200 mg/1 N 20181231 62011-0015_354a9652-112d-4b9d-9ec5-90807046c0b2 62011-0015 HUMAN OTC DRUG Health Mart Ibuprofen Ibuprofen TABLET, COATED ORAL 20111121 ANDA ANDA072096 McKesson IBUPROFEN 200 mg/1 N 20181231 62011-0016_93b28bed-f1b4-4d54-84ef-ea70612ef243 62011-0016 HUMAN OTC DRUG IBUPROFEN IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20120409 ANDA ANDA078682 McKesson (Health Mart) IBUPROFEN 200 mg/1 E 20171231 62011-0017_08c59ab2-e356-4730-a19c-328b5d92b4ad 62011-0017 HUMAN OTC DRUG Health Mart Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20111121 ANDA ANDA074661 McKesson NAPROXEN SODIUM 220 mg/1 N 20181231 62011-0019_5956201e-9c77-605d-e053-2991aa0ad790 62011-0019 HUMAN OTC DRUG Aspirin ASPIRIN TABLET, DELAYED RELEASE ORAL 20111101 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 N 20181231 62011-0020_c9777dec-cd67-4620-9044-f92fe3d43221 62011-0020 HUMAN OTC DRUG Health Mart Aspirin Aspirin TABLET ORAL 20111121 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 325 mg/1 N 20181231 62011-0021_46c80d38-192f-4162-950f-d392775df31d 62011-0021 HUMAN OTC DRUG health mart aspirin Aspirin TABLET, CHEWABLE ORAL 20111121 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 N 20181231 62011-0023_75a03f11-a0ad-4855-a119-10d20f3f6c08 62011-0023 HUMAN OTC DRUG Health Mart Pain Relief Acetaminophen TABLET ORAL 20111121 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 N 20181231 62011-0024_ff40259c-4634-4c18-94c6-be365b37b960 62011-0024 HUMAN OTC DRUG Extra Strength Acetaminophen PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20120409 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 62011-0025_a9035aad-668a-4612-bf19-d0e2dcdfebec 62011-0025 HUMAN OTC DRUG Extra Strength Acetaminophen PM Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20120604 OTC MONOGRAPH NOT FINAL part343 McKesson (Health Mart) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 62011-0026_5b1ac45c-e54f-4ee6-a3d9-9c3202b98361 62011-0026 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Health Mart ACETAMINOPHEN 650 mg/1 N 20181231 62011-0027_48c84ab9-4041-4693-bfa1-7046efbc906a 62011-0027 HUMAN OTC DRUG health mart pain relief Acetaminophen TABLET, FILM COATED ORAL 20111121 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 N 20191231 62011-0028_3d55baab-702a-44f3-ba96-ac258ee389cd 62011-0028 HUMAN OTC DRUG health mart aspirin Aspirin TABLET, CHEWABLE ORAL 20111121 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 N 20181231 62011-0030_a3910ce8-d82d-45a8-a536-abb8b7fbda6f 62011-0030 HUMAN OTC DRUG health mart ibuprofen Ibuprofen SUSPENSION ORAL 20111121 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL N 20181231 62011-0032_5956201e-9c63-605d-e053-2991aa0ad790 62011-0032 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20111101 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 325 mg/1 N 20181231 62011-0035_982b3d84-4e67-4a28-a5ff-0373f419482c 62011-0035 HUMAN OTC DRUG Motion Relief - Less Drowsy Formula MECLIZIN HCl TABLET ORAL 20120626 OTC MONOGRAPH FINAL part336 McKesson (Health Mart) MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0036_129ef163-78c8-4ebf-aaa7-d075651c4107 62011-0036 HUMAN OTC DRUG Original Formula Motion Sickness Relief DIMENHYDRINATE TABLET ORAL 20120626 OTC MONOGRAPH FINAL part336 McKesson (Health Mart) DIMENHYDRINATE 50 mg/1 N 20181231 62011-0037_270147fb-680b-43bd-b652-28274b0308d0 62011-0037 HUMAN OTC DRUG Health Mart Sleep Aid Doxylamine succinate TABLET ORAL 20111121 ANDA ANDA040167 McKesson DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 62011-0040_2b458c14-a40c-4cc6-8aa6-8b814e27ee5c 62011-0040 HUMAN OTC DRUG Health Mart Regular Strength Enteric Coated Aspirin ASPIRIN TABLET, COATED ORAL 20120605 OTC MONOGRAPH NOT FINAL part343 McKesson (Health Mart) ASPIRIN 325 mg/1 N 20181231 62011-0045_ab6dca76-4fd9-4843-8845-07cf18b2ba69 62011-0045 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part333A McKesson Medical ISOPROPYL ALCOHOL .7 mL/1 N 20181231 62011-0047_fba915a3-ac20-49b5-999d-622b392998e8 62011-0047 HUMAN OTC DRUG health mart nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20111121 ANDA ANDA078325 McKesson NICOTINE 2 mg/1 N 20181231 62011-0048_e40d5e5b-8c18-460d-8107-9452b3857b00 62011-0048 HUMAN OTC DRUG health mart nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20111121 ANDA ANDA077007 McKesson NICOTINE 2 mg/1 N 20181231 62011-0049_d4f2e75b-16d0-4359-98bd-60ace94c3636 62011-0049 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 N 20181231 62011-0050_089fb34b-60af-29f6-2ac3-4808f2cbbc6e 62011-0050 HUMAN OTC DRUG HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20150814 NDA NDA020076 McKesson NICOTINE 7 mg/24h N 20181231 62011-0051_b43f8ac6-0253-42e2-8d7e-f0db637c963c 62011-0051 HUMAN OTC DRUG Health Mart Pharmacy Childrens Cetirizine Hydrochloride Cetirizine hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Health Mart CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 62011-0052_9af9e102-bddf-48ba-a636-773f6c665305 62011-0052 HUMAN OTC DRUG 24-Hour All Day Allergy Cetirizine HCl TABLET ORAL 20120427 ANDA ANDA078780 McKesson CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 62011-0053_ecdd6b92-0355-4404-a8a6-573a6625db22 62011-0053 HUMAN OTC DRUG Fiber Psyllium husk CAPSULE ORAL 20120322 OTC MONOGRAPH FINAL part334 Health Mart PSYLLIUM HUSK 520 mg/1 N 20181231 62011-0054_325479b7-092c-4b2b-812b-c5f214556737 62011-0054 HUMAN OTC DRUG health mart allergy complete childrens cetirizine Hydrochloride LIQUID ORAL 20120111 ANDA ANDA090254 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 62011-0055_e94bebcf-bc0d-4b9a-beb5-f09b602981af 62011-0055 HUMAN OTC DRUG health mart allergy complete d Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20120113 ANDA ANDA077170 McKesson CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 62011-0056_08e57aee-c9b5-47db-83d5-39e99fd195e7 62011-0056 HUMAN OTC DRUG MULTI-SYMPTOM ALLERGY diphenhydramine hydrochloride CAPSULE ORAL 20120214 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0057_6553d828-1683-4326-bef4-7a2d4737b2d3 62011-0057 HUMAN OTC DRUG Health mart allergy childrens Diphenhydramine HCl LIQUID ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 62011-0058_71dd6da7-1362-4882-a5cd-f2d70c336406 62011-0058 HUMAN OTC DRUG Allergy DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20120517 OTC MONOGRAPH NOT FINAL part348 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0059_2e8c27da-e1d9-40d0-9252-fee3ea4d630d 62011-0059 HUMAN OTC DRUG health mart allergy relief Chlorpheniramine Maleate TABLET ORAL 20120118 OTC MONOGRAPH FINAL part341 McKesson CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 62011-0060_e2bac304-8a3a-4964-8f6e-8ff967a726fa 62011-0060 HUMAN OTC DRUG HealthMart Chest Congestion Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Mckesson GUAIFENESIN 400 mg/1 N 20181231 62011-0061_7d9e6223-bc0f-4c28-80ff-8b7144c6c07e 62011-0061 HUMAN OTC DRUG HealthMart Chest Congestion Relief DMDM DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 62011-0062_e7583f39-f2f0-4739-a92a-69639d14d2a8 62011-0062 HUMAN OTC DRUG health mart cold and allergy childrens phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 62011-0063_da982008-e932-4e57-9ee2-5587df95d4ce 62011-0063 HUMAN OTC DRUG Health Mart Cold and Cough childrens Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20120112 OTC MONOGRAPH FINAL part341 McKesson BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 62011-0065_8ac59de1-e685-4f28-bf31-75613d8549d9 62011-0065 HUMAN OTC DRUG health mart daytime acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20120111 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 62011-0066_6220593d-a0bd-4395-8df9-2b62a967751a 62011-0066 HUMAN OTC DRUG NON-DROWSY DAY TIME ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20120201 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 62011-0067_798f4e09-5236-4581-8244-081422d4ae55 62011-0067 HUMAN OTC DRUG health mart fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20120118 ANDA ANDA076447 McKesson FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 62011-0068_c16c1d4c-94b8-4eac-8e23-5ace4e36a6d4 62011-0068 HUMAN OTC DRUG Health Mart fexofenadine hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20120126 ANDA ANDA076447 McKesson FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 62011-0070_27c8311e-e8fc-4685-8119-99cf63be7e0f 62011-0070 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Health Mart IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 62011-0071_211fe879-58f3-434a-b277-e81a1f73cae7 62011-0071 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Health Mart LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 62011-0071_cdecad62-bf1e-43fb-b4be-8fc54b63e4ae 62011-0071 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170606 ANDA ANDA076557 Health Mart LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 62011-0072_9aea93a6-1122-4bbd-934d-bf8e15aa0964 62011-0072 HUMAN OTC DRUG Health Mart Pharmacy Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Health Mart LORATADINE 5 mg/5mL N 20181231 62011-0073_47949aaf-807a-4b1a-96e6-2e4f9fe836b5 62011-0073 HUMAN OTC DRUG HealthMart Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Health Mart LORATADINE 10 mg/1 N 20181231 62011-0074_d7a38897-cdb1-4d08-8782-b48c70a56cef 62011-0074 HUMAN OTC DRUG health mart allergy relief Loratadine TABLET ORAL 20120113 ANDA ANDA076301 McKesson LORATADINE 10 mg/1 N 20181231 62011-0075_882e6429-54f2-426a-801d-c6faa10b79d3 62011-0075 HUMAN OTC DRUG Medicated Chest CAMPHOR,EUCALYPTUS OIL,MENTHOL JELLY TOPICAL 20120202 OTC MONOGRAPH FINAL part341 McKesson CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg N 20181231 62011-0076_b63f178c-afe8-4332-ba7c-32dd23415bb9 62011-0076 HUMAN OTC DRUG Health Mart Mucus ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20130319 ANDA ANDA078912 McKesson GUAIFENESIN 600 mg/1 N 20181231 62011-0077_28186557-13bc-4cb6-987f-873522c896bf 62011-0077 HUMAN OTC DRUG health mart nasal decongestant pe Phenylephrine Hydrochloride TABLET ORAL 20111223 OTC MONOGRAPH FINAL part341 McKesson PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 62011-0078_bef7b07b-6ced-4133-b101-7e74e85cd0b6 62011-0078 HUMAN OTC DRUG health mart nasal decongestant Pseudoephedrine HCl TABLET, FILM COATED ORAL 20111223 OTC MONOGRAPH FINAL part341 McKesson PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 62011-0079_2384243a-c8c5-4399-a169-6b9c6cf36a5b 62011-0079 HUMAN OTC DRUG health mart nasal oxymetazoline hydrochloride SPRAY NASAL 20120111 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 62011-0080_2c9723ed-44d7-4f87-b4eb-e504bfd459a5 62011-0080 HUMAN OTC DRUG health mart nasal oxymetazoline hydrochloride SPRAY NASAL 20120112 OTC MONOGRAPH FINAL part341 McKesson OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 62011-0082_4e928e4c-018b-4230-898b-a23df800ff77 62011-0082 HUMAN OTC DRUG health mart night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 62011-0083_60c71411-28a6-4951-bf0e-e2d281ba81a5 62011-0083 HUMAN OTC DRUG health mart night time cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 62011-0084_eecf5a55-3a93-4f1c-86d9-548ea8854e2a 62011-0084 HUMAN OTC DRUG Health Mart Multi-Symptom Cold and Flu Night Time ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20120409 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 62011-0085_c45cf8ef-36e3-4b98-92b9-ab0ffbe1c0aa 62011-0085 HUMAN OTC DRUG health mart nose Phenylephrine hydrochloride SOLUTION/ DROPS NASAL 20120111 OTC MONOGRAPH FINAL part341 McKesson PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 62011-0087_de7abc65-6399-4379-a570-be05f1f69df0 62011-0087 HUMAN OTC DRUG Health Mart nasal decongestant Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120111 ANDA ANDA075153 McKesson PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 62011-0089_6d2f3d74-251b-4e3d-8c04-4485cfbf745f 62011-0089 HUMAN OTC DRUG health mart adult tussin Guaifenesin SOLUTION ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson GUAIFENESIN 200 mg/10mL N 20181231 62011-0090_ba859ee0-d2ca-4ac9-a754-90f7ae7e8f1f 62011-0090 HUMAN OTC DRUG health mart adult tussin Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20120124 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 62011-0091_6ff74f68-907e-4325-a1bb-d54e313f2a02 62011-0091 HUMAN OTC DRUG health mart adult tussin Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20191231 62011-0092_82c84b85-a907-4da4-8406-d2c72d811200 62011-0092 HUMAN OTC DRUG health mart adult tussin Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20120111 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 62011-0093_7347f8b3-c133-4236-b9b5-ddbb7fc617cd 62011-0093 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Cetirizine hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Health Mart CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 62011-0094_3dce7e40-187d-4a9f-a977-b4e4e548714d 62011-0094 HUMAN OTC DRUG Health Mart Pharmacy Bacitracin Zinc First Aid Antibiotic bacitracin zinc OINTMENT TOPICAL 19901205 OTC MONOGRAPH FINAL part333B Health Mart BACITRACIN ZINC 500 [USP'U]/g N 20181231 62011-0095_b7914043-9983-4c18-83d3-6bf9637c0940 62011-0095 HUMAN OTC DRUG Health Mart Pharmacy Hydrocortisone Maximum Strength with Aloe hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Health Mart HYDROCORTISONE 1 g/100g N 20181231 62011-0096_97ac5ca4-8a66-4363-8300-c9d41dbb4a74 62011-0096 HUMAN OTC DRUG Health Mart Pharmacy Hydrocortisone Maximum Strength Plus 12 Moisturizers hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Health Mart HYDROCORTISONE 1 g/100g N 20181231 62011-0097_60b89345-c6d6-4d74-ada0-1050d8912fd6 62011-0097 HUMAN OTC DRUG Double Antibiotic Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Health Mart BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 62011-0098_41b9963f-3c3c-4315-b985-9334be186e2f 62011-0098 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Health Mart BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 62011-0099_5939be35-58bd-4f1c-84e8-5b131072290a 62011-0099 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20120312 OTC MONOGRAPH FINAL part333B Health Mart BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 62011-0100_c32a5199-2b3c-45c3-83d1-0dae63b240d8 62011-0100 HUMAN OTC DRUG Eye Drops Redness and Dry Eye Relief Naphazoline hydrochloride, Glycerin SOLUTION/ DROPS OPHTHALMIC 20120301 OTC MONOGRAPH FINAL part349 McKesson NAPHAZOLINE HYDROCHLORIDE; GLYCERIN .12; 2 mg/mL; mg/mL N 20181231 62011-0101_27f326c7-e818-4e6b-9bfb-cf1d423909c9 62011-0101 HUMAN OTC DRUG Artificial Tears Polyvinyl alcohol, Povidone SOLUTION/ DROPS OPHTHALMIC 20120301 OTC MONOGRAPH FINAL part349 McKesson POLYVINYL ALCOHOL; POVIDONE 5; 6 mg/mL; mg/mL N 20181231 62011-0102_cd528b3c-d746-47ab-8c39-b4cb9fd2ea4e 62011-0102 HUMAN OTC DRUG Eye Drops Regular Tetrahydrozoline hydrochloride SOLUTION/ DROPS OPHTHALMIC 20120301 OTC MONOGRAPH FINAL part349 McKesson TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 62011-0104_c1b667f2-71b2-460f-b643-38423b80dfc5 62011-0104 HUMAN OTC DRUG Eye Drops Advanced Relief Tetrahydrozoline hydrochloride, Polyethylene glycol 400, Dextran 70, Povidone SOLUTION/ DROPS OPHTHALMIC 20120301 OTC MONOGRAPH FINAL part349 McKesson TETRAHYDROZOLINE HYDROCHLORIDE; POLYETHYLENE GLYCOL 400; DEXTRAN 70; POVIDONE .5; 10; 1; 10 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62011-0106_bba9d049-568c-4409-b947-7066b263cdce 62011-0106 HUMAN OTC DRUG Ethyl Rubbing Alcohol alcohol LIQUID TOPICAL 20120330 OTC MONOGRAPH NOT FINAL part333A McKesson (Health Mart) ALCOHOL 70 mL/100mL N 20181231 62011-0107_bae57026-1753-400c-a97b-a9f9401df180 62011-0107 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 percent Isopropyl Alcohol LIQUID TOPICAL 20141130 OTC MONOGRAPH NOT FINAL part333A McKesson (Health Mart) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 62011-0108_5adf924e-da75-40d4-a467-b54a7572de80 62011-0108 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A McKesson (Health Mart) ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 62011-0109_d8527c43-97ac-4bd5-b4a9-43a86494430e 62011-0109 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate Magnesium sulfate GRANULE ORAL; TOPICAL 20161031 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) MAGNESIUM SULFATE 1 g/g N 20181231 62011-0111_16554448-00ac-4ce4-8d13-adf25b921c51 62011-0111 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20141130 OTC MONOGRAPH NOT FINAL part356 McKesson (Health Mart) HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 62011-0114_6052f53d-df00-32ad-e053-2991aa0ae24a 62011-0114 HUMAN OTC DRUG Health Mart Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 McKesson ZINC OXIDE 160 mg/mL N 20181231 62011-0115_44be6f02-0d30-4b81-b65c-137a437f649d 62011-0115 HUMAN OTC DRUG Glycerin Glycerin LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part347 McKesson GLYCERIN 995 mg/mL N 20181231 62011-0116_5f73144a-70aa-304b-e053-2a91aa0a437e 62011-0116 HUMAN OTC DRUG Health Mart Iodides Alcohol LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL .48 mL/mL N 20181231 62011-0117_5f9f4a09-7f35-066a-e053-2a91aa0aaa2f 62011-0117 HUMAN OTC DRUG Health Mart Iodine Tincture Mild Iodine and Sodium Iodide and Alcohol LIQUID TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A McKesson IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 62011-0118_26bf0d3a-c367-4c93-9186-1fba163661a0 62011-0118 HUMAN OTC DRUG Humco Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A McKesson POVIDONE-IODINE 100 mg/mL N 20181231 62011-0119_e0bdebe2-46d3-41e1-86d8-43c366ed6959 62011-0119 HUMAN OTC DRUG health mart lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20120228 OTC MONOGRAPH FINAL part358G McKesson PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL N 20181231 62011-0120_efd2f798-e11c-405d-b48c-603d55523547 62011-0120 HUMAN OTC DRUG health mart allergy and congestion Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120306 ANDA ANDA076050 McKesson LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 62011-0122_60c8a88c-59a8-7336-e053-2a91aa0a68c7 62011-0122 HUMAN OTC DRUG ADVANCED ANTACID CHERRY aluminum hydroxide, magnesium hydroxide, simethicone LIQUID ORAL 20120601 OTC MONOGRAPH FINAL part331 McKesson ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 62011-0123_04ded39a-e6dd-59b8-e054-00144ff8d46c 62011-0123 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20120401 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 62011-0124_04eadf40-b664-3666-e054-00144ff8d46c 62011-0124 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20120401 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 62011-0126_3da18749-9beb-4487-8975-edc43bfee134 62011-0126 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate LIQUID ORAL 20150131 OTC MONOGRAPH FINAL part335 McKesson (Health Mart) BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 62011-0127_6f193f81-a5a3-49b2-bd7c-1efdbd28a649 62011-0127 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part335 McKesson (Health Mart) BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 62011-0131_a98908ec-013f-4107-bf72-657788251fb6 62011-0131 HUMAN OTC DRUG Health Mart Calcium antacid Assorted Fruit Calcium carbonate TABLET, CHEWABLE ORAL 20120401 OTC MONOGRAPH FINAL part331 Health Mart CALCIUM CARBONATE 750 mg/1 N 20181231 62011-0132_d0d791f0-b820-4253-a2df-7a7c9b1f9efb 62011-0132 HUMAN OTC DRUG Health Mart calcium antacid calcium carbonate TABLET, CHEWABLE ORAL 20120401 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 500 mg/1 N 20181231 62011-0133_bbbe05ef-dbee-4bff-b5a4-dcacd1d49ed1 62011-0133 HUMAN OTC DRUG Smooth texture Orange flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20120421 OTC MONOGRAPH NOT FINAL part334 HEALTH MART PSYLLIUM HUSK 3.4 g/12g N 20181231 62011-0134_a38a07d4-0791-4ed9-9446-663673191469 62011-0134 HUMAN OTC DRUG Health Mart fiber caplets Methylcellulose TABLET ORAL 20120423 OTC MONOGRAPH FINAL part334 McKesson METHYLCELLULOSE (4000 CPS) 500 mg/1 N 20181231 62011-0135_1a38c9a6-7035-4a4a-857b-a5436cf026fd 62011-0135 HUMAN OTC DRUG Original texture Orange flavor psyllium husk POWDER, FOR SUSPENSION ORAL 20120421 OTC MONOGRAPH NOT FINAL part334 HEALTH MART PSYLLIUM HUSK 3.4 g/11g N 20181231 62011-0136_0259721d-64bc-4d51-a8a7-3830e60c8824 62011-0136 HUMAN OTC DRUG Bulk-forming Laxative psyllium husk POWDER, FOR SUSPENSION ORAL 20120419 OTC MONOGRAPH NOT FINAL part334 HEALTH MART PSYLLIUM HUSK 3.4 g/7g N 20181231 62011-0137_4a145697-965e-4a46-81cc-b99535f3c132 62011-0137 HUMAN OTC DRUG Health Mart fiber psyllium husk POWDER, FOR SUSPENSION ORAL 20120412 OTC MONOGRAPH NOT FINAL part334 Health Mart PSYLLIUM HUSK 3.4 g/5.8g N 20181231 62011-0138_4273514d-2706-4fdb-a2ca-67905b876673 62011-0138 HUMAN OTC DRUG Health Mart gas relief simethicone TABLET, CHEWABLE ORAL 20120401 OTC MONOGRAPH FINAL part332 Mckesson DIMETHICONE 80 mg/1 N 20181231 62011-0139_49b0d299-ee12-4a01-aa96-ae707eb70062 62011-0139 HUMAN OTC DRUG Health Mart Simethicone Simethicone EMULSION ORAL 20120401 OTC MONOGRAPH FINAL part332 McKesson DIMETHICONE 20 mg/.3mL N 20181231 62011-0140_3287befc-65ab-4978-bc0e-687da3f8cb23 62011-0140 HUMAN OTC DRUG Health Mart Stomach relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20120401 OTC MONOGRAPH FINAL part335 McKesson BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 62011-0141_603eef40-32f4-07f0-e053-2991aa0a574f 62011-0141 HUMAN OTC DRUG Health Mart Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 McKesson CASTOR OIL 1 mg/mL N 20181231 62011-0142_ada32eac-40de-4d86-af2a-16becdbf1bf2 62011-0142 HUMAN OTC DRUG health mart famotidine Famotidine TABLET ORAL 20120320 ANDA ANDA075400 McKesson FAMOTIDINE 10 mg/1 N 20181231 62011-0143_d2a7b77a-83c1-4e01-981f-8b447bddef7a 62011-0143 HUMAN OTC DRUG Health Mart Famotidine Famotidine TABLET ORAL 20120320 ANDA ANDA077351 McKesson FAMOTIDINE 20 mg/1 N 20181231 62011-0147_2b60399c-2836-4009-a62c-ddb194b32d08 62011-0147 HUMAN OTC DRUG health mart antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone LIQUID ORAL 20120320 OTC MONOGRAPH FINAL part332 McKesson ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 62011-0148_cac0eb2d-f396-41c3-9718-cffbbc58f3e8 62011-0148 HUMAN OTC DRUG health mart antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20120320 OTC MONOGRAPH FINAL part332 McKesson ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/10mL; mg/10mL; mg/10mL N 20181231 62011-0149_60c8df27-ce7b-aa38-e053-2a91aa0a49a3 62011-0149 HUMAN OTC DRUG MAXIMUM STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20120401 OTC MONOGRAPH FINAL part331 McKesson ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 62011-0150_d46b9303-049e-4496-af37-2e01f8274fd2 62011-0150 HUMAN OTC DRUG health mart anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20120320 ANDA ANDA075232 McKesson LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 62011-0151_5ffac51a-1caa-4568-a2f9-acf2922a5804 62011-0151 HUMAN OTC DRUG health mart loperamide hydrochloride loperamide HCl LIQUID ORAL 20120320 ANDA ANDA091292 McKesson LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 62011-0152_6feaad10-cbb2-4131-ad8b-c4d45e4a3e5b 62011-0152 HUMAN OTC DRUG Health Mart anti nausea Dextrose (glucose), Levulose (fructose), Phosphoric Acid SOLUTION ORAL 20120320 UNAPPROVED DRUG OTHER McKesson DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID 1.87; 1.87; 21.5 g/5mL; g/5mL; mg/5mL N 20181231 62011-0153_fe99cd98-a727-42c1-b66d-5baf9b2e5ee1 62011-0153 HUMAN OTC DRUG health mart clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20120320 ANDA ANDA090685 McKesson POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 62011-0157_e109bd94-553e-478c-a5f2-93571b2b4a18 62011-0157 HUMAN OTC DRUG health mart omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20120320 NDA NDA022032 McKesson OMEPRAZOLE 20 mg/1 N 20181231 62011-0158_c49f6421-be3a-4feb-b5f2-6eeff8f37328 62011-0158 HUMAN OTC DRUG Loperamide HCl LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20120625 NDA NDA021855 McKesson (Health Mart) LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 62011-0159_a9cf8b58-2b55-466d-8210-fc878252c4ef 62011-0159 HUMAN OTC DRUG Laxative BISACODYL TABLET, COATED ORAL 20120627 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) BISACODYL 5 mg/1 N 20181231 62011-0160_254b70df-bb4f-4922-b947-e38e16f70b47 62011-0160 HUMAN OTC DRUG Health Mart Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20120605 OTC MONOGRAPH FINAL part347 McKesson (Health Mart) DIMETHICONE 125 mg/1 N 20181231 62011-0161_2946579c-1b53-4a57-b39b-80645d5bd012 62011-0161 HUMAN OTC DRUG Senna-S DOCUSATE SODIUM, SENNOSIDES TABLET, COATED ORAL 20120518 OTC MONOGRAPH NOT FINAL part334 McKesson DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 62011-0162_b86fb8bf-952f-40a2-a5ae-319fb30d0355 62011-0162 HUMAN OTC DRUG Senna Sennosides TABLET ORAL 20120518 OTC MONOGRAPH FINAL part334 McKesson SENNOSIDES A AND B 8.6 mg/1 N 20181231 62011-0163_e6291a91-9efc-4bca-9262-22c60686a5a4 62011-0163 HUMAN OTC DRUG Health Mart Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120518 OTC MONOGRAPH NOT FINAL part334 McKesson DOCUSATE SODIUM 100 mg/1 N 20181231 62011-0165_98cc822d-b9ac-497e-bc02-f05f3c1c3eb3 62011-0165 HUMAN OTC DRUG Stool Softener with Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20120518 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 N 20181231 62011-0166_7b040e55-72d6-40d3-92a6-9083125b854b 62011-0166 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20120320 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM CITRATE 1.745 g/29.6mL N 20191231 62011-0167_4635a059-1d0d-4f98-b6ff-272ecb6d4f2d 62011-0167 HUMAN OTC DRUG Earwax Removal Aid Earwax Removal Aid LIQUID AURICULAR (OTIC) 20120206 OTC MONOGRAPH FINAL part344 McKesson CARBAMIDE PEROXIDE 6.5 mg/100mL E 20171231 62011-0168_88fca5d0-d259-409e-abd8-5a738b0d5065 62011-0168 HUMAN OTC DRUG health mart lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120521 ANDA ANDA202319 McKesson LANSOPRAZOLE 15 mg/1 N 20181231 62011-0169_9144cd5d-32fc-46c9-ab5d-ad364894d321 62011-0169 HUMAN OTC DRUG Earwax Removal Kit Earwax Removal Kit LIQUID AURICULAR (OTIC) 20120206 OTC MONOGRAPH FINAL part344 McKesson CARBAMIDE PEROXIDE 6.5 mg/100mL E 20171231 62011-0170_15753afb-6e7f-4680-98c2-068f20130701 62011-0170 HUMAN OTC DRUG health mart nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20140402 ANDA ANDA078326 McKesson NICOTINE 4 mg/1 N 20181231 62011-0171_6cca7934-9d19-4b0e-be8a-4fe9ee9afdf3 62011-0171 HUMAN OTC DRUG health mart nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20111121 ANDA ANDA077007 McKesson NICOTINE 4 mg/1 N 20181231 62011-0172_089fb34b-60af-29f6-2ac3-4808f2cbbc6e 62011-0172 HUMAN OTC DRUG HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20150814 NDA NDA020076 McKesson NICOTINE 14 mg/24h N 20181231 62011-0173_089fb34b-60af-29f6-2ac3-4808f2cbbc6e 62011-0173 HUMAN OTC DRUG HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TOPICAL 20150814 NDA NDA020076 McKesson NICOTINE 21 mg/24h N 20181231 62011-0174_11062c92-30ce-4685-9949-4ad4bf042cc5 62011-0174 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20120320 OTC MONOGRAPH NOT FINAL part334 McKesson MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 62011-0175_07917449-edf4-476f-b7c3-77cde855c5a0 62011-0175 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20141130 OTC MONOGRAPH FINAL part347 McKesson (Health Mart) WITCH HAZEL 842 mg/mL N 20181231 62011-0176_8f385f7f-f005-4d7a-bf6a-cc0b46fcdd62 62011-0176 HUMAN OTC DRUG Health Mart Cough DM dextromethorphan polistirex SUSPENSION ORAL 20120828 ANDA ANDA091135 McKesson DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 62011-0180_6e2f4ef2-5a3d-40a9-a4a6-e9c671970f97 62011-0180 HUMAN OTC DRUG HealthMart Childrens Cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 McKesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 62011-0181_b20bded9-6686-44fc-b797-16ab3b01ecdb 62011-0181 HUMAN OTC DRUG HealthMart Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 McKesson LORATADINE 5 mg/5mL N 20181231 62011-0183_daf375b7-83d8-4d70-a45c-43782ac8bf99 62011-0183 HUMAN OTC DRUG Health Mart Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20130117 OTC MONOGRAPH NOT FINAL part343 Mckesson ACETAMINOPHEN 160 mg/5mL N 20181231 62011-0187_edbaabec-6739-4314-baa8-b7dfe20f6c3a 62011-0187 HUMAN OTC DRUG infants gas relief drops simethicone EMULSION ORAL 20121101 OTC MONOGRAPH FINAL part332 Health Mart DIMETHICONE 20 mg/.3mL N 20181231 62011-0188_f30b1e59-21d4-4ec3-a91b-e772c1fa5ce2 62011-0188 HUMAN OTC DRUG Stool Softener with Laxative Docusate sodium and Sennosides TABLET ORAL 20120410 OTC MONOGRAPH NOT FINAL part334 Mckesson (Health Mart) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 62011-0189_28f05cb2-91b0-4111-a443-b5999ca1e9d4 62011-0189 HUMAN OTC DRUG gas relief simethicone TABLET, CHEWABLE ORAL 20121001 OTC MONOGRAPH FINAL part332 Health Mart DIMETHICONE 125 mg/1 N 20181231 62011-0190_61f4eb7d-b61b-4c69-8350-19977def7b50 62011-0190 HUMAN OTC DRUG HealthMart Pharmacy Lubricant Laxative mineral oil ENEMA RECTAL 20140127 OTC MONOGRAPH NOT FINAL part334 McKesson MINERAL OIL 118 mL/118mL E 20171231 62011-0191_516825ce-c642-4d71-9669-006bba9ade82 62011-0191 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20130822 OTC MONOGRAPH NOT FINAL part334 McKesson SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 62011-0192_6f7c1283-b6d1-456f-98a4-87305d798294 62011-0192 HUMAN OTC DRUG Senna Natural vegetable laxative SENNOSIDES TABLET ORAL 20120315 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) SENNOSIDES 8.6 mg/1 N 20181231 62011-0193_c98a0d1f-c973-4629-aa81-aa107170e28b 62011-0193 HUMAN OTC DRUG adult cold, flu and sore throat acteaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 1/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 62011-0194_65e99d86-bcd6-43c4-928b-c113597c97df 62011-0194 HUMAN OTC DRUG adult severe congestion and cough Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Health Mart DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 62011-0195_75cab1ba-72f4-47b9-ae9e-c1778d974ddc 62011-0195 HUMAN OTC DRUG Childrens mucus relief multi-symptom cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20121201 OTC MONOGRAPH FINAL part341 Health Mart DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 62011-0196_b61ecaaa-f2cb-4fa0-8392-78319b00dc65 62011-0196 HUMAN OTC DRUG Dry eye relief Glycerin, Hypromellose, Polyethylene glycol LIQUID OPHTHALMIC 20130501 OTC MONOGRAPH FINAL part349 McKesson Corporation HYPROMELLOSES; GLYCERIN; POLYETHYLENE GLYCOL 400 .2; .2; 1 g/100mL; g/100mL; g/100mL N 20181231 62011-0197_c0501f39-cf86-46db-b8ae-046b1d7e2b6f 62011-0197 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130430 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 62011-0198_61658294-01c3-4cbd-bdc7-7e689ef6d8e4 62011-0198 HUMAN OTC DRUG Health Mart Cough DM dextromethorphan polistirex SUSPENSION ORAL 20130618 ANDA ANDA091135 McKesson DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 62011-0199_1349a7b0-6ce0-40d4-8fd2-017c1d6d893a 62011-0199 HUMAN OTC DRUG Health Mart nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20130610 ANDA ANDA203690 McKesson NICOTINE 2 mg/1 N 20181231 62011-0200_5b96f11a-9c0c-4e1b-8d45-02d1fde1c3c4 62011-0200 HUMAN OTC DRUG Health Mart Nicotine Nicotine Polacrilex LOZENGE ORAL 20130702 ANDA ANDA203690 Mckesson NICOTINE 4 mg/1 N 20181231 62011-0201_5964809b-6a9f-452e-a4f7-e732ab37a3a8 62011-0201 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130331 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 62011-0203_b770e5a3-85f4-433a-abd7-778273b3d2d6 62011-0203 HUMAN OTC DRUG Health Mart Lubricating Plus carboxymethylcellulose sodium SOLUTION, GEL FORMING / DROPS OPHTHALMIC 20130610 OTC MONOGRAPH FINAL part349 Mckesson CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM .5 g/100mL N 20181231 62011-0204_6fb5dfc6-a67c-49cf-9fbf-87bdb5018294 62011-0204 HUMAN OTC DRUG Health Mart Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20130815 ANDA ANDA076518 McKesson NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 62011-0205_628cf975-5d38-4012-b1a8-799829ae78c4 62011-0205 HUMAN OTC DRUG All Day Allergy 24 hour Cetirizine HCl TABLET ORAL 20120101 ANDA ANDA078780 McKesson (Health Mart) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 62011-0209_76d21f83-1ccc-437b-a1c7-a10c0623d1b8 62011-0209 HUMAN OTC DRUG Health Mart Muscle Rub Menthol, Methyl salicylate CREAM TOPICAL 20131014 OTC MONOGRAPH NOT FINAL part348 McKesson MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g N 20181231 62011-0210_6b4d5379-a7d0-414f-a0f9-fd9902b1ec9f 62011-0210 HUMAN OTC DRUG Health Mart Z Sleep Diphenhydramine HCl SOLUTION ORAL 20130716 OTC MONOGRAPH FINAL part338 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 62011-0211_ea8ad6ad-c16c-4f36-984b-95de78d9bb54 62011-0211 HUMAN OTC DRUG Health Mart Adult Tussin DM Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20130813 OTC MONOGRAPH FINAL part341 McKesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 62011-0212_c75c3cac-a160-4402-885d-31c61fe42ea2 62011-0212 HUMAN OTC DRUG Health Mart Aspirin Aspirin TABLET, CHEWABLE ORAL 20130813 OTC MONOGRAPH NOT FINAL part343 McKesson ASPIRIN 81 mg/1 N 20181231 62011-0213_c36847c0-4741-4178-8a1a-697c068591fd 62011-0213 HUMAN OTC DRUG Health Mart Ibuprofen IB Ibuprofen TABLET, FILM COATED ORAL 20131026 ANDA ANDA077349 McKesson IBUPROFEN 200 mg/1 N 20181231 62011-0214_202b3571-7c30-43f5-91dc-6744f3f2f391 62011-0214 HUMAN OTC DRUG Health Mart Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20130813 ANDA ANDA074937 McKesson IBUPROFEN 100 mg/5mL N 20181231 62011-0215_c993bf24-6007-4516-9bbc-49dd68ee0206 62011-0215 HUMAN OTC DRUG Health Mart Nighttime Sleep Aid Diphenhydramine Hydrochloride TABLET ORAL 20130813 OTC MONOGRAPH FINAL part338 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0217_1cc4b5c6-3a4a-4260-af6f-6ab8d5a5a1eb 62011-0217 HUMAN OTC DRUG HealthMart Mucus Relief FM Acetaminophen, guaifenesin, Phenylephrine HCl TABLET ORAL 20130404 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 62011-0218_3bcc776a-f2ec-4032-b2b6-a689dd247b15 62011-0218 HUMAN OTC DRUG HealthMart Mucus Relief FM Acetaminophen, dextromethorphan HBr, guaifenesin, Phenylephrine HCl TABLET ORAL 20130404 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 62011-0219_6012d1e9-1ba6-42a7-91dd-9e85ab76a01c 62011-0219 HUMAN OTC DRUG HealthMart Mucus Relief FM Acetaminophen, dextromethorphan HBr, guaifenesin, Phenylephrine HCl TABLET ORAL 20130404 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 62011-0221_a12eedac-6230-4d0e-9f3e-6c964a3071cf 62011-0221 HUMAN OTC DRUG Health Mart z-sleep Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140131 OTC MONOGRAPH FINAL part338 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0222_ed8e32e4-b9ec-456d-8666-6ffcb7bc012e 62011-0222 HUMAN OTC DRUG Health Mart Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20111121 ANDA ANDA077349 McKesson IBUPROFEN 200 mg/1 N 20181231 62011-0224_a04e97cf-6095-4e67-97eb-b8bdba463943 62011-0224 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130813 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) DOCUSATE SODIUM 100 mg/1 N 20181231 62011-0225_210820c3-6696-458a-ab49-6933aa23a9f2 62011-0225 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20130920 ANDA ANDA201745 Health Mart RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 62011-0226_bf96f9c1-5630-4ac8-aa69-8203f699bcf0 62011-0226 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 62011-0227_c706df7c-3483-4f12-ac87-2e7fe39bf5e8 62011-0227 HUMAN OTC DRUG acid reducer Ranitidine TABLET ORAL 20140107 ANDA ANDA200536 McKesson RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 62011-0228_0bd2dcf6-3289-4321-903f-b80526ea8803 62011-0228 HUMAN OTC DRUG Helath Mart Childrens allergy relief dye free Diphenhydramine HCl LIQUID ORAL 20140909 OTC MONOGRAPH FINAL part341 McKesson DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 62011-0229_917d30f4-0427-4987-8e01-a94e0a0814e5 62011-0229 HUMAN OTC DRUG Healthmart Calcium Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20130808 OTC MONOGRAPH FINAL part331 Mckesson CALCIUM CARBONATE 750 mg/1 N 20181231 62011-0230_60f34c08-baad-4cf2-930a-9ce252d5a5df 62011-0230 HUMAN OTC DRUG Health Mart Junior Rapid Melts Acetaminophen TABLET, CHEWABLE ORAL 20130801 OTC MONOGRAPH NOT FINAL part343 Mckesson ACETAMINOPHEN 160 mg/1 N 20181231 62011-0231_dae14eb1-1075-4437-b6b3-e63f013e3e45 62011-0231 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131202 OTC MONOGRAPH FINAL part347 McKesson (Health Mart) DIMETHICONE 125 mg/1 N 20181231 62011-0232_ab5e1a1a-15f8-454c-8226-f9e5eb71aeb9 62011-0232 HUMAN OTC DRUG eye itch relief ketotifen fumarate SOLUTION/ DROPS OPHTHALMIC 20140207 ANDA ANDA077958 McKesson Corp. KETOTIFEN FUMARATE .35 mg/mL N 20181231 62011-0233_feb83f81-32b9-46f3-8407-9a23ea787f75 62011-0233 HUMAN OTC DRUG health mart fexofenadine hydrochloride fexofenadine hcl TABLET, FILM COATED ORAL 20140401 ANDA ANDA076447 McKesson FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 62011-0236_629987c1-abf3-4149-afba-f306c55e44ad 62011-0236 HUMAN OTC DRUG Health Mart Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140611 ANDA ANDA091292 McKesson LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 62011-0237_281fb8d9-75c6-28a7-e054-00144ff8d46c 62011-0237 HUMAN OTC DRUG Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% LIQUID TOPICAL 20140220 NDA NDA019125 McKesson CHLORHEXIDINE GLUCONATE 4 mg/100mL N 20181231 62011-0238_062dd7dd-a043-58a1-e054-00144ff8d46c 62011-0238 HUMAN OTC DRUG Pain Reliever Rapid Release Acetaminophen TABLET, COATED ORAL 20141024 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 500 mg/1 N 20181231 62011-0239_f4eb65c1-b943-43b8-bc6f-95de446bb483 62011-0239 HUMAN OTC DRUG Health Mart Daytime acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20140610 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 62011-0240_066b8682-1a30-48ea-e054-00144ff8d46c 62011-0240 HUMAN OTC DRUG Severe Sinus Congestion and Pain ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141027 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 62011-0241_066b8682-1a44-48ea-e054-00144ff8d46c 62011-0241 HUMAN OTC DRUG Severe Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20141027 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 62011-0243_123214a2-e723-4f4c-8dad-bcce616081e9 62011-0243 HUMAN OTC DRUG health mart migraine relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20140422 ANDA ANDA075794 McKesson ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 62011-0244_b517b975-7db3-4598-963e-908282590ce7 62011-0244 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20140530 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) DOCUSATE SODIUM 250 mg/1 N 20181231 62011-0245_4dbbea8d-ee51-4dc5-b5b8-1eb36019246a 62011-0245 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140731 OTC MONOGRAPH NOT FINAL part356 McKesson (Health Mart) PHENOL 1.4 g/100mL N 20181231 62011-0246_990da49c-5fe0-4b2c-b801-cb4a0642a078 62011-0246 HUMAN OTC DRUG health mart childrens pain and fever Acetaminophen SUSPENSION ORAL 20140919 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL N 20191231 62011-0247_b694de6a-cb94-4a2f-87fb-d8d197c1bc02 62011-0247 HUMAN OTC DRUG health mart pain and fever childrens Acetaminophen SUSPENSION ORAL 20140904 OTC MONOGRAPH NOT FINAL part343 McKesson ACETAMINOPHEN 160 mg/5mL N 20191231 62011-0248_69664ec4-ce52-4dd5-a9f5-56dd0a8e6ef5 62011-0248 HUMAN OTC DRUG health mart loratadine Loratadine TABLET ORAL 20141002 ANDA ANDA076301 McKesson LORATADINE 10 mg/1 N 20181231 62011-0249_414aa151-2ffb-406f-a719-f9823c442429 62011-0249 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141031 NDA NDA021920 McKesson (Health Mart) NAPROXEN SODIUM 220 mg/1 N 20181231 62011-0250_28350c4a-9e9e-46fe-ba57-863a122640a8 62011-0250 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20141231 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 62011-0251_8d689e7e-0d05-4416-9b79-b5aca60e0d47 62011-0251 HUMAN OTC DRUG health mart cough dm dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150428 ANDA ANDA091135 McKesson DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 62011-0253_a33eb574-586a-47f2-a64a-64d95f059e1b 62011-0253 HUMAN OTC DRUG health mart severe cold cough and flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20150528 OTC MONOGRAPH FINAL part341 McKesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 62011-0254_81e35f6c-c38b-4272-83f8-df5ba4da5929 62011-0254 HUMAN OTC DRUG Health Mart Lubricating Tears Polyethylene glycol, propylene glycol LIQUID OPHTHALMIC 20150701 OTC MONOGRAPH FINAL part349 Mckesson Corporation POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL .4; .3 g/100mL; g/100mL N 20181231 62011-0255_7a58fcdb-72cf-4851-afd6-aaee01bcd57a 62011-0255 HUMAN OTC DRUG health mart lice treatment Permethrin LOTION TOPICAL 20150803 ANDA ANDA076090 McKesson PERMETHRIN 1 mg/100mL N 20181231 62011-0256_2592eb35-54fe-4f72-a1b6-6f272d1d94c2 62011-0256 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20150731 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 62011-0258_90ec0e73-a2e5-48de-88db-e82bed94b147 62011-0258 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20160601 ANDA ANDA075209 HealthMart LORATADINE 10 mg/1 N 20181231 62011-0259_ee08a1ea-39af-41ae-8dd9-fbd3c07f796e 62011-0259 HUMAN OTC DRUG Health Mart mucus relief d Guaifenesin, pseudoephedrine hydrochloride TABLET ORAL 20151221 ANDA ANDA091071 McKesson GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 62011-0261_aeddf110-8f2c-42b9-92ae-6becc8429fc0 62011-0261 HUMAN OTC DRUG Daytime Non Drowsy ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20150930 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 62011-0262_720b8efd-e16a-43af-bde5-2f2ea15d02dd 62011-0262 HUMAN OTC DRUG NightTime Cold and Flu Multi Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20151231 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 62011-0264_589f35c7-7522-48fe-a3ad-154bdc6acbfc 62011-0264 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 20151031 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0265_6e4984ff-e3c3-4602-9211-8e00b6e1f26e 62011-0265 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20150819 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL 70 mL/100mL N 20181231 62011-0266_603f2137-98cf-9f24-e053-2a91aa0a90aa 62011-0266 HUMAN OTC DRUG Health Mart Alcohol Isopropyl Rubbing 70 Percent Isopropyl Alcohol LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A McKesson ISOPROPYL ALCOHOL 700 mg/mL N 20181231 62011-0267_603f3828-0d04-3273-e053-2991aa0a0ad3 62011-0267 HUMAN OTC DRUG Health Mart Hydrogen Peroxide 3 Percent hydrogen peroxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A McKesson HYDROGEN PEROXIDE 30 mg/mL N 20181231 62011-0268_60c6dcaf-4290-790b-e053-2a91aa0acd06 62011-0268 HUMAN OTC DRUG Health Mart Witch Hazel Witch Hazel LIQUID TOPICAL 20160101 OTC MONOGRAPH FINAL part347 McKesson WITCH HAZEL 855 mg/mL N 20181231 62011-0269_3d72be15-d934-47c8-bb16-a23f1dab8dba 62011-0269 HUMAN OTC DRUG health mart allergy relief nasal 24 hr Fluticasone propionate SPRAY, METERED NASAL 20160529 ANDA ANDA207957 Mckesson FLUTICASONE PROPIONATE 50 ug/1 N 20181231 62011-0270_be2cc44e-4a69-4a4f-9464-a68dffc9da57 62011-0270 HUMAN OTC DRUG HealthMart Mineral Oil Single Laxative Mineral Oil ENEMA RECTAL 20120510 OTC MONOGRAPH NOT FINAL part334 McKesson MINERAL OIL 118 g/118mL N 20181231 62011-0271_158f79ed-4363-4e5f-97a2-fd098394312c 62011-0271 HUMAN OTC DRUG HealthMart Saline Single Laxative Sodium Phosphate, Dibasic and Sodium Phosphate, Monobasic, Unspecified Form ENEMA RECTAL 20120320 OTC MONOGRAPH NOT FINAL part334 McKesson SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 7; 19 g/118mL; g/118mL N 20181231 62011-0272_5fb443d1-b22a-71c6-e053-2991aa0aa14c 62011-0272 HUMAN OTC DRUG Health Mart Isopropyl Alcohol 91 Percent Isopropyl Alcohol LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A McKesson ISOPROPYL ALCOHOL 910 mg/mL N 20181231 62011-0273_c5f23468-df26-436e-bab3-4be5c8f59e73 62011-0273 HUMAN OTC DRUG Stool Softener with laxative docusate sodium and sennosides TABLET ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 62011-0274_36f5b630-daca-4aff-a9ca-cf7ee5967f49 62011-0274 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20151130 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 62011-0276_22fe8de4-9a72-4c16-a744-2f4250cee207 62011-0276 HUMAN OTC DRUG health mart dual action complete famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20160112 ANDA ANDA077355 McKesson FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 62011-0277_51cedecf-c39a-4f22-a283-053a6922a396 62011-0277 HUMAN OTC DRUG laxative Bisacodyl TABLET, COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 McKesson (Health Mart) BISACODYL 5 mg/1 N 20181231 62011-0278_73637aaa-da24-4c5f-8c70-e7aeda754ff7 62011-0278 HUMAN OTC DRUG Health Mart Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20160326 OTC MONOGRAPH FINAL part335 Mckesson BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 62011-0279_150a0129-de4e-4d87-81ad-8e1545d8a6bf 62011-0279 HUMAN OTC DRUG health mart stomach relief Bismuth subsalicylate SUSPENSION ORAL 20160313 OTC MONOGRAPH FINAL part335 McKesson BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 62011-0280_f31de3c8-8a42-46c8-8c90-5cecf489e8be 62011-0280 HUMAN OTC DRUG Health Mart Calcium Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160516 OTC MONOGRAPH FINAL part331 Mckesson CALCIUM CARBONATE 750 mg/1 N 20181231 62011-0281_5476c824-f4cd-4db2-92fd-b84efe2d0060 62011-0281 HUMAN OTC DRUG health mart calcium antacid calcium carbonate TABLET, CHEWABLE ORAL 20160529 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 500 mg/1 N 20181231 62011-0282_e3e858a6-4692-4ed2-a402-3edc3ba21348 62011-0282 HUMAN OTC DRUG Health Mart acid reducer Ranitidine TABLET, FILM COATED ORAL 20160510 ANDA ANDA091429 Mckesson RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 62011-0283_c4d7ef3d-47bc-4e45-8b95-24504a05a0e7 62011-0283 HUMAN OTC DRUG Health Mart Acid Reducer Ranitidine TABLET, COATED ORAL 20160523 ANDA ANDA076195 Mckesson RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 62011-0284_e80013ee-aa28-4625-8258-e3d869100477 62011-0284 HUMAN OTC DRUG health mart childrens allergy relief Diphenhydramine HCl SOLUTION ORAL 20160315 OTC MONOGRAPH FINAL part341 Mckesson DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 62011-0285_fd5097cb-ed6b-47b2-90a9-c3187b45abbe 62011-0285 HUMAN OTC DRUG Health Mart childrens all day allergy cetirizine Hydrochloride SOLUTION ORAL 20160226 ANDA ANDA090254 Mckesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 62011-0286_3ec58345-31a8-62a4-e054-00144ff8d46c 62011-0286 HUMAN OTC DRUG STOOL SOFTENER docusate sodium TABLET ORAL 20160201 OTC MONOGRAPH NOT FINAL part334 McKesson DOCUSATE SODIUM 100 mg/1 N 20181231 62011-0287_40e25379-1305-326e-e054-00144ff88e88 62011-0287 HUMAN OTC DRUG CLEARLAX polyethylene glycol 3350 POWDER, FOR SOLUTION ORAL 20160701 ANDA ANDA090812 MCKESSON POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 62011-0289_404015f1-e114-4632-e054-00144ff8d46c 62011-0289 HUMAN OTC DRUG SENNA Sennosides TABLET ORAL 20160201 OTC MONOGRAPH NOT FINAL part334 MCKESSON SENNOSIDES 8.6 mg/1 N 20181231 62011-0290_40e4e30f-139c-5e69-e054-00144ff8d46c 62011-0290 HUMAN OTC DRUG SENNA-S Sennosides and Docusate Sodium TABLET, FILM COATED ORAL 20160201 OTC MONOGRAPH NOT FINAL part334 SUNMARK SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 62011-0291_40f88c2c-5222-5ca2-e054-00144ff8d46c 62011-0291 HUMAN OTC DRUG GAS RELIEF Simethicone TABLET, CHEWABLE ORAL 20160401 OTC MONOGRAPH FINAL part332 MCKESSON DIMETHICONE 80 mg/1 N 20181231 62011-0292_3fdd097b-87b4-46d2-e054-00144ff88e88 62011-0292 HUMAN OTC DRUG ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20160101 OTC MONOGRAPH FINAL part331 MCKESSON (HEALTH MART) ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 62011-0294_d34f49ce-9878-47df-b772-011425f07177 62011-0294 HUMAN OTC DRUG Health Mart Calcium Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20160606 OTC MONOGRAPH FINAL part331 Mckesson CALCIUM CARBONATE 1000 mg/1 N 20181231 62011-0295_cc1d5e96-2715-4ec0-bdf4-ed5081a69918 62011-0295 HUMAN OTC DRUG health mart calcium antacid Calcium carbonate TABLET, CHEWABLE ORAL 20160529 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 750 mg/1 N 20181231 62011-0296_c5a21a9c-5bf8-4acb-8dba-109d69c52595 62011-0296 HUMAN OTC DRUG health mart hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20160508 OTC MONOGRAPH FINAL part346 McKesson MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 62011-0297_a80fbb2f-3945-4d07-9dd5-f275618694cf 62011-0297 HUMAN OTC DRUG Health Mart Redness Relief Glycerin, Naphazoline hydrochloride LIQUID OPHTHALMIC 20150701 OTC MONOGRAPH FINAL part349 McKesson Corporation GLYCERIN; NAPHAZOLINE HYDROCHLORIDE .25; .012 g/100mL; g/100mL N 20181231 62011-0298_204ad606-c3d6-43e0-af6c-16acd9304a50 62011-0298 HUMAN OTC DRUG Health Mart Clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20160406 ANDA ANDA090685 Mckesson POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 62011-0299_097f85c2-8fa9-42a6-852d-4b05a34d0b7a 62011-0299 HUMAN OTC DRUG Health Mart Mucus D Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160314 ANDA ANDA091009 Mckesson GUAIFENESIN 1200 mg/1 N 20181231 62011-0300_1376905f-ea07-4278-bbb7-ccfc62d0f484 62011-0300 HUMAN OTC DRUG health mart calcium antacid calcium carbonate TABLET, CHEWABLE ORAL 20160516 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 1000 mg/1 N 20181231 62011-0301_d54d928d-2752-455a-889d-c09cc2eb5fdc 62011-0301 HUMAN OTC DRUG health mart calcium antacid calcium carbonate TABLET, CHEWABLE ORAL 20160529 OTC MONOGRAPH FINAL part331 McKesson CALCIUM CARBONATE 750 mg/1 N 20181231 62011-0302_4ec2c3af-6e4b-44e6-a7d2-73c385694533 62011-0302 HUMAN OTC DRUG Health Mart mucus relief DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160711 ANDA ANDA091070 Mckesson DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 62011-0304_ac752e65-3609-434f-90b4-0f1f5d29ca31 62011-0304 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part347 McKesson (Health Mart) DIMETHICONE 125 mg/1 N 20181231 62011-0305_9551d1a4-198b-40bb-9a46-ac931e42808d 62011-0305 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Health Mart LORATADINE 5 mg/5mL N 20181231 62011-0306_918b2a90-532b-4358-bdff-9ad48c167a7e 62011-0306 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170220 ANDA ANDA075153 Mckesson PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 62011-0307_5d6722e2-c513-0075-e171-9a8fa23e65f7 62011-0307 HUMAN OTC DRUG cetirizine hydrochloride Cetirizine Hydrochloride Tablets TABLET, FILM COATED ORAL 20160930 ANDA ANDA078343 MCKESSON CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 62011-0309_4ec4734b-e1d3-4d89-a3ef-282d0239401b 62011-0309 HUMAN OTC DRUG allergy relief diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0310_7c8c0424-7fed-4504-a461-98710f8335e9 62011-0310 HUMAN OTC DRUG allergy relief diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0311_ca388c31-122c-4fde-ae49-ed8742fd60af 62011-0311 HUMAN OTC DRUG allergy relief Chlorpheniramine maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 62011-0312_f891a423-c2e2-4432-83ea-f890a555f720 62011-0312 HUMAN OTC DRUG nasal decongestant non-drowsy Pseudoephedrine HCl TABLET, FILM COATED ORAL 19810825 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 62011-0313_741f9f6a-6d01-464a-80bf-4a01a6c751b1 62011-0313 HUMAN OTC DRUG all day allergy Cetirizine HCl TABLET ORAL 20150805 ANDA ANDA090760 McKESSON Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 62011-0314_0f14674e-2d40-45c6-800c-e418bbecd617 62011-0314 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20161014 ANDA ANDA202039 MCKESSON FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 62011-0315_0f14674e-2d40-45c6-800c-e418bbecd617 62011-0315 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20161014 ANDA ANDA202039 MCKESSON FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 62011-0316_e1070c0c-c77f-462b-9916-3df02804a71d 62011-0316 HUMAN OTC DRUG Allergy Diphenhydramine Hydrochloride TABLET ORAL 20161125 OTC MONOGRAPH FINAL part341 Mckesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0317_c3f9c626-c837-4b65-b706-6948420c8974 62011-0317 HUMAN OTC DRUG Allergy Diphenhydramine Hydrochloride CAPSULE ORAL 20161125 OTC MONOGRAPH FINAL part341 Mckesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0318_0fc6fc30-404a-44ff-8cd2-8c1c4c612b94 62011-0318 HUMAN OTC DRUG DayTime Cold and Flu Acetaminophen,Dextromethorphan,Phenylephrine CAPSULE, LIQUID FILLED ORAL 20161125 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 62011-0319_66014619-d0d4-4a78-b1eb-0bfeabb4a840 62011-0319 HUMAN OTC DRUG Chest Congestion Relief Guaifenesin and Dextromethorphan HBr TABLET ORAL 20161125 OTC MONOGRAPH FINAL part341 Mckesson GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 62011-0320_48bab924-f8b2-46b9-8a82-d4c281fc5d81 62011-0320 HUMAN OTC DRUG Health Mart 24 hour nasal allergy Triamcinolone acetonide SPRAY, METERED NASAL 20161226 ANDA ANDA078104 Mckesson TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 62011-0321_34406031-fcf2-4049-a58e-b6870a15d450 62011-0321 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20151215 OTC MONOGRAPH FINAL part333B Health Mart BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 62011-0322_353b9b3e-95c6-4722-a378-9e724b986f77 62011-0322 HUMAN OTC DRUG Health Mart childrens all day allergy Cetirizine HCl SOLUTION ORAL 20161031 ANDA ANDA204226 Mckesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 62011-0323_a947dbe8-aa58-447a-8b09-a38e0c87aee7 62011-0323 HUMAN OTC DRUG Health Mart Childrens all day allergy Cetirizine HCl SOLUTION ORAL 20161024 ANDA ANDA204226 Mckesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 62011-0324_d202e8e5-cc5d-487f-9a6f-12ceb75664f8 62011-0324 HUMAN OTC DRUG Health Mart Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20161016 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 62011-0325_f2ffc975-c0a3-4aa5-9ae1-cdf24b6c6aef 62011-0325 HUMAN OTC DRUG HealthMart Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER McKesson PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 62011-0326_7ecca48e-ab36-473d-afa8-b86fd9e3753e 62011-0326 HUMAN OTC DRUG HealthMart Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20150115 UNAPPROVED DRUG OTHER McKesson PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 62011-0327_8957c14a-694e-4eb5-ad2e-96f06b2edba6 62011-0327 HUMAN OTC DRUG HealthMart Gentle Laxative Bisacodyl SUPPOSITORY RECTAL 20150213 OTC MONOGRAPH NOT FINAL part334 McKesson BISACODYL 10 mg/2000mg N 20181231 62011-0328_b12015d0-6514-4f68-bebd-88ed2048821b 62011-0328 HUMAN OTC DRUG Health Mart Pain Relief Camphor, Menthol, and Methyl Salicylate PATCH TOPICAL 20170123 OTC MONOGRAPH NOT FINAL part348 McKesson CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 7.1; 33; 36 mg/1; mg/1; mg/1 N 20181231 62011-0329_602ee07d-7700-4328-e053-2991aa0ad96b 62011-0329 HUMAN OTC DRUG Health Mart Extra Strength Pain Relief Menthol PATCH TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part348 McKesson MENTHOL 428.5 mg/1 N 20181231 62011-0331_e0c49322-3bfc-4c95-94a1-d415e0da2a39 62011-0331 HUMAN OTC DRUG Health Mart Medicated Cooling Witch Hazel CLOTH TOPICAL 20170329 OTC MONOGRAPH FINAL part346 Mckesson (Health Mart) WITCH HAZEL 500 mg/1 N 20181231 62011-0332_161e4709-1b8c-435e-8cfe-95c04178e9f8 62011-0332 HUMAN OTC DRUG health mart esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170924 ANDA ANDA207193 Mckesson ESOMEPRAZOLE 20 mg/1 N 20181231 62011-0333_7809731f-0193-4cd4-80c8-b00c30639af6 62011-0333 HUMAN OTC DRUG Health Mart Arthritis Creme Trolamine Salicylate CREAM TOPICAL 20170616 OTC MONOGRAPH NOT FINAL part348 Mckesson TROLAMINE SALICYLATE 10 g/100g N 20181231 62011-0334_049347a1-b4a3-4752-988d-3e75e3bbffda 62011-0334 HUMAN OTC DRUG Health Mart Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20170507 ANDA ANDA076359 McKesson IBUPROFEN 100 mg/1 N 20181231 62011-0335_43ef154b-1833-40fd-b30c-d7fd5a3661f5 62011-0335 HUMAN OTC DRUG Health Mart ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, FILM COATED ORAL 20170530 ANDA ANDA079113 Mckesson DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 62011-0336_9ee76ef3-e782-4eba-8cff-3674507e89c4 62011-0336 HUMAN OTC DRUG health mart pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170507 ANDA ANDA075077 Mckesson ACETAMINOPHEN 650 mg/1 N 20181231 62011-0337_c91daf6a-70ad-43b2-a793-c912b66286bd 62011-0337 HUMAN OTC DRUG Health Mart arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170516 ANDA ANDA075077 McKesson ACETAMINOPHEN 650 mg/1 N 20181231 62011-0338_5a298db4-e0bf-4523-99b2-8e1f49dd984d 62011-0338 HUMAN OTC DRUG Health Mart arthritis pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170530 ANDA ANDA075077 Mckesson ACETAMINOPHEN 650 mg/1 N 20181231 62011-0339_f0ac2d30-ec3d-4cb9-8e1b-3d893927f405 62011-0339 HUMAN OTC DRUG childrens chewables acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 McKesson (Health Mart) ACETAMINOPHEN 160 mg/1 N 20181231 62011-0340_1f7d4c17-fffb-4a5f-9688-ab2db6ece877 62011-0340 HUMAN OTC DRUG stay awake caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 McKesson (Health Mart) CAFFEINE 200 mg/1 N 20181231 62011-0341_33044c30-49e0-4f05-9a6c-afb9be0430f1 62011-0341 HUMAN OTC DRUG motion sickness dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 McKesson (Health Mart) DIMENHYDRINATE 50 mg/1 N 20181231 62011-0342_966bf39e-294b-4156-ae56-56cda27e6947 62011-0342 HUMAN OTC DRUG Z-sleep diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH FINAL part338 McKesson (Health Mart) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0343_e71504ef-cdeb-4e26-b995-bd1804c23afc 62011-0343 HUMAN OTC DRUG nighttime sleep aid diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 McKesson (Health Mart) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0344_6b89f2e2-1d49-4e98-91c3-4558e194ef0b 62011-0344 HUMAN OTC DRUG sleep aid nighttime doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 McKesson (Health Mart) DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 62011-0345_4cee7f3c-587b-4985-9e80-2ddba68d6aa4 62011-0345 HUMAN OTC DRUG motion sickness relief meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 McKesson (Health Mart) MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 62011-0346_b16e892f-1ba8-4f4e-9705-52ae429917e7 62011-0346 HUMAN OTC DRUG Mucus Relief DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 McKESSON Corporation GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 600; 30 mg/1; mg/1 N 20191231 62011-0347_daef2ab1-ad83-4acc-95f4-00847e8a4810 62011-0347 HUMAN OTC DRUG Mucus Guaifenesin TABLET, EXTENDED RELEASE ORAL 20171015 NDA NDA021282 MCKESSON (HEALTH MART) GUAIFENESIN 600 mg/1 N 20181231 62011-0348_f5a63123-c6d2-4b6f-910d-a1d250e34604 62011-0348 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Health Mart LORATADINE 5 mg/5mL N 20181231 62011-0349_9b21f9ce-fe34-6b20-c558-39bb28ea814a 62011-0349 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 20170703 ANDA ANDA074612 McKesson (Healthmart) NICOTINE 7 mg/24h N 20181231 62011-0350_9b21f9ce-fe34-6b20-c558-39bb28ea814a 62011-0350 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 20170703 ANDA ANDA074612 McKesson (Healthmart) NICOTINE 14 mg/24h N 20181231 62011-0351_9b21f9ce-fe34-6b20-c558-39bb28ea814a 62011-0351 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 20170703 ANDA ANDA074612 McKesson (Healthmart) NICOTINE 21 mg/24h N 20181231 62011-0353_bea8cc36-1762-40de-910b-cae93f4ec885 62011-0353 HUMAN OTC DRUG Ethyl Alcohol Ethyl Alcohol LIQUID TOPICAL 20090518 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL 610 mg/mL N 20181231 62011-0355_e4db3048-6736-41bf-a6b0-fd860374f23c 62011-0355 HUMAN OTC DRUG Daytime Liquid Caps Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 McKesson (Health Mart) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 62011-0360_96a03c7a-8fd4-477f-8667-3e267a098711 62011-0360 HUMAN OTC DRUG MAXIMUM STRENGTH MUCUS RELIEF DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 McKESSON Corporation GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 62011-0370_02bc998b-6f04-4349-92bd-497bb8e45f77 62011-0370 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A McKesson ALCOHOL 70 mL/100mL N 20181231 62011-0500_3d5106a3-f191-4e2e-a0f7-41adbc1aa57b 62011-0500 HUMAN OTC DRUG Saline Laxative sodium phosphate ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 McKesson SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL E 20171231 62011-0552_1298bb1d-6fdb-48bb-86eb-b51f19dbe6fb 62011-0552 HUMAN OTC DRUG All Day Allergy Cetirizine HCl TABLET ORAL 20120208 ANDA ANDA078780 McKesson (Health Mart) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 62011-0831_3c07e645-18d5-4223-827f-8b254f99bd27 62011-0831 HUMAN OTC DRUG Health Mart Pharmacy Mineral OIL ORAL 20021113 OTC MONOGRAPH NOT FINAL part334 McKesson MINERAL OIL 999 mg/mL N 20181231 62011-2520_46cdc819-5c37-460d-8485-c8338a19a425 62011-2520 HUMAN OTC DRUG Health Mart severe cold cough and flu Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride POWDER, FOR SOLUTION ORAL 20151009 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 62018-001_f2da3bf8-e597-443e-9439-631920c46477 62018-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS Respiratory Home Care Specialists, Inc. OXYGEN 99 L/100L E 20171231 62032-070_921d7b0e-fba5-4f65-880d-d12dc35314d7 62032-070 HUMAN OTC DRUG NU-DERM PHYSICAL UV BROAD SPECTRUM SPF 32 ZINC OXIDE LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part352 OMP, Inc. ZINC OXIDE 185 mg/g N 20181231 62032-072_affadfae-ce06-42b6-a044-ee621d6ea727 62032-072 HUMAN OTC DRUG ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 SUNCREEN TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20090101 OTC MONOGRAPH FINAL part352 OMP, Inc. TITANIUM DIOXIDE; ZINC OXIDE 20; 155 mg/mL; mg/mL E 20171231 62032-100_5340a775-399e-4233-a30d-e4e872023d3f 62032-100 HUMAN PRESCRIPTION DRUG NU-DERM BLENDER Skin Lightener and Blending HYDROQUINONE CREAM TOPICAL 19880101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 62032-101_5340a775-399e-4233-a30d-e4e872023d3f 62032-101 HUMAN PRESCRIPTION DRUG NU-DERM CLEAR Skin Bleaching and Corrector HYDROQUINONE CREAM TOPICAL 19880101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 62032-102_4eac9f57-6759-444e-9182-d01ff3f52155 62032-102 HUMAN OTC DRUG NU-DERM PHYSICAL UV BLOCK SPF 32 ZINC OXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH FINAL part352 OMP, Inc. ZINC OXIDE 185 mg/g E 20171231 62032-103_f05364b7-1473-4cf3-81d7-3e2b031d545e 62032-103 HUMAN OTC DRUG ROSACLEAR SKIN BALANCING SUN PROTECTION SPF 30 SUNCREEN TITANIUM DIOXIDE and ZINC OXIDE LOTION TOPICAL 20090101 OTC MONOGRAPH FINAL part352 OMP, Inc. TITANIUM DIOXIDE; ZINC OXIDE 20; 155 mg/mL; mg/mL E 20171231 62032-104_c9ef85c0-cdaa-43ff-8ea3-803e30fb1bb4 62032-104 HUMAN OTC DRUG NU-DERM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN OCTINOXATE and ZINC OXIDE LOTION TOPICAL 20121107 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 105 mg/g; mg/g N 20181231 62032-105_63c9e7c1-cc9d-49f8-b123-b1ae9302ab4e 62032-105 HUMAN PRESCRIPTION DRUG OBAGI-C RX SYSTEM C-THERAPY NIGHT HYDROQUINONE CREAM TOPICAL 20100101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 62032-106_37bb4a75-bd82-412b-a92e-b9e5e73fb0f2 62032-106 HUMAN PRESCRIPTION DRUG OBAGI C RX SYSTEM C CLARIFYING SERUM HYDROQUINONE SOLUTION TOPICAL 20100101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/mL Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 62032-107_76884509-2659-4338-b34a-d7cd907cb82f 62032-107 HUMAN OTC DRUG OBAGI-C RX SYSTEM C-SUNGUARD SPF 30 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20020101 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 90 mg/mL; mg/mL N 20181231 62032-108_6c4ef21b-f06a-4a19-b667-5bea96e12ada 62032-108 HUMAN OTC DRUG OBAGI-C RX SYSTEM C-EXFOLIATING DAY with Vitamin C OCTISALATE, OCTINOXATE, and OXYBENZONE LOTION TOPICAL 20040101 OTC MONOGRAPH FINAL part352 OMP, INC. OCTISALATE; OCTINOXATE; OXYBENZONE 50; 75; 40 mg/mL; mg/mL; mg/mL N 20181231 62032-110_1d93c707-3b66-4904-bc9c-deda90d26ab8 62032-110 HUMAN OTC DRUG CLENZIDERM PORE THERAPY ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20070201 OTC MONOGRAPH FINAL part333D OMP, INC. SALICYLIC ACID 20 mg/mL N 20181231 62032-111_209d04e7-f03e-4697-9a04-f0d7026bdba0 62032-111 HUMAN OTC DRUG CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20070201 OTC MONOGRAPH FINAL part333D OMP, INC. SALICYLIC ACID 20 mg/mL N 20181231 62032-112_6e04ac42-958e-4163-a585-c9f9212801f6 62032-112 HUMAN OTC DRUG NU-DERM Tolereen Anti-pruritic Hydrocortisone LOTION TOPICAL 19880101 OTC MONOGRAPH NOT FINAL part348 OMP, Inc. HYDROCORTISONE 5 mg/g N 20181231 62032-113_93b5a3fe-6f00-49bc-be4e-cc4847be1eb4 62032-113 HUMAN OTC DRUG CLENZIDERM THERAPEUTIC BENZOYL PEROXIDE LOTION TOPICAL 20070701 OTC MONOGRAPH FINAL part333D OMP, INC. BENZOYL PEROXIDE 50 mg/mL N 20181231 62032-114_fb7eb714-3ab6-48ff-acb4-47880e5a0e89 62032-114 HUMAN OTC DRUG CLENZIDERM THERAPEUTIC MOISTURIZER GLYCERIN CREAM TOPICAL 20070701 OTC MONOGRAPH FINAL part347 OMP, INC. GLYCERIN 200 mg/mL N 20181231 62032-115_177c26ac-3552-4d11-816d-717a5752a16c 62032-115 HUMAN PRESCRIPTION DRUG CONDITION AND ENHANCE BLENDER Skin Lightener and Blending HYDROQUINONE CREAM TOPICAL 19880101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 62032-116_5340a775-399e-4233-a30d-e4e872023d3f 62032-116 HUMAN PRESCRIPTION DRUG NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE HYDROQUINONE, OCTINOXATE, and OXYBENZONE LOTION TOPICAL 19840101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE; OCTINOXATE; OXYBENZONE 40; 75; 55 mg/g; mg/g; mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 62032-117_177c26ac-3552-4d11-816d-717a5752a16c 62032-117 HUMAN PRESCRIPTION DRUG CONDITION AND ENHANCE CLEAR Skin Bleaching and Corrector HYDROQUINONE CREAM TOPICAL 19880101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 62032-118_be81dac4-75d9-4625-b1f1-c84473ce995b 62032-118 HUMAN OTC DRUG CONDITION AND ENHANCE PHYSICAL UV BLOCK SPF 32 ZINC OXIDE CREAM TOPICAL 20040101 OTC MONOGRAPH FINAL part352 OMP, Inc. ZINC OXIDE 185 mg/g E 20171231 62032-119_d849a01a-d751-4bd9-b02a-082968689a93 62032-119 HUMAN OTC DRUG CONDITION AND ENHANCE HEALTHY SKIN PROTECTION SPF 35 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20020101 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 90 mg/mL; mg/mL E 20171231 62032-120_278051da-6898-4975-9573-261ef688a2f7 62032-120 HUMAN PRESCRIPTION DRUG ELASTIDERM DECOLLETAGE SKIN LIGHTENING COMPLEX Chest and Neck HYDROQUINONE LOTION TOPICAL 20101201 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 62032-121_c49b3eed-0822-42fb-8ec9-6dfb2715fb31 62032-121 HUMAN OTC DRUG OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN OCTINOXATE and ZINC OXIDE LOTION TOPICAL 20121107 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 105 mg/g; mg/g N 20181231 62032-122_dd5ff7c5-9175-4140-ade7-cc3c0c6197a3 62032-122 HUMAN PRESCRIPTION DRUG OBAGI C RX SYSTEM C CLARIFYING SERUM HYDROQUINONE LIQUID TOPICAL 20100101 UNAPPROVED DRUG OTHER OMP, INC. HYDROQUINONE 40 mg/mL Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 62032-124_c9df5cc8-c811-416c-9e8a-b7eba0d49b3e 62032-124 HUMAN OTC DRUG NU-DERM SUN SHIELD SPF 50 SUNSCREEN ZINC OXIDE and OCTINOXATE LOTION TOPICAL 20110105 OTC MONOGRAPH FINAL part352 OMP, Inc. ZINC OXIDE; OCTINOXATE 105; 75 mg/mL; mg/mL E 20171231 62032-125_36d4fd66-04d4-4218-a7b6-3c5bc28c134b 62032-125 HUMAN OTC DRUG SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN OCTINOXATE and ZINC OXIDE LOTION TOPICAL 20130221 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 105 mg/g; mg/g N 20181231 62032-128_c528dd6c-000a-4f69-8f47-f1479ad44df5 62032-128 HUMAN OTC DRUG Professional-C Suncare Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part352 Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 27.9; 30 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 62032-129_db6fb272-6194-432d-a05c-7b87c11bd373 62032-129 HUMAN OTC DRUG DAILY CARE FOAMING CLEANSER ACNE TREATMENT SALICYLIC ACID LIQUID TOPICAL 20130118 OTC MONOGRAPH FINAL part333D OMP, INC. SALICYLIC ACID 20 mg/mL N 20181231 62032-130_12532e36-5e7a-4fcb-a0d4-36819ae38ca5 62032-130 HUMAN OTC DRUG GENTLE REJUVENATION FORTIFIED SUNSCREEN BROAD SPECTRUM SPF 30 WITH VITAMIN C AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE CREAM TOPICAL 20131104 OTC MONOGRAPH FINAL part352 Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 27.9; 30 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 62032-131_13520a24-3b31-4653-9cd1-5cb1ef1c742d 62032-131 HUMAN OTC DRUG GENTLE REJUVENATION ULTRA LIGHT REPAIR SPF 30 SUNSCREEN HOMOSALATE, OCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM TOPICAL 20131015 OTC MONOGRAPH FINAL part352 Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC. HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 120; 75; 20; 49 mg/g; mg/g; mg/g; mg/g N 20181231 62032-150_6456fc28-3df5-4d49-9f40-8ef2e4fdd9e5 62032-150 HUMAN OTC DRUG Obagi Sun Shield TINT Cool Sunscreen Broad Spectrum SPF 50 Homosalate, Octinoxate, Titanium dioxide, Zinc oxide LOTION TOPICAL 20160101 OTC MONOGRAPH FINAL part352 OMP, INC. HOMOSALATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 8.5; 6.375; 2.677; 4.25 g/85g; g/85g; g/85g; g/85g N 20181231 62032-160_b1aacb4d-7ede-4aae-8d6a-afff2a057e46 62032-160 HUMAN OTC DRUG Obagi Sun Shield TINT Warm Sunscreen Broad Spectrum SPF 50 Homosalate, Octinoxate, Titanium dioxide, Zinc oxide LOTION TOPICAL 20160101 OTC MONOGRAPH FINAL part352 OMP, INC. HOMOSALATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 8.5; 6.375; 2.711; 4.25 g/85g; g/85g; g/85g; g/85g N 20181231 62032-200_a433566c-f2d3-4415-a875-2b5f5d67dc9f 62032-200 HUMAN OTC DRUG NU-DERM HEALTHY SKIN PROTECTION SPF 35 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20020101 OTC MONOGRAPH FINAL part352 OMP, Inc. OCTINOXATE; ZINC OXIDE 75; 90 mg/mL; mg/mL N 20191231 62032-300_6a22eb2d-4fee-42db-903c-ab5fa1a88a0d 62032-300 HUMAN OTC DRUG Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 SUNSCREEN AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part352 OMP, INC. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 10; 75; 50; 50 mg/g; mg/g; mg/g; mg/g N 20181231 62032-412_f9640f0b-46cd-457d-b626-413648ba5631 62032-412 HUMAN PRESCRIPTION DRUG Tretinoin Cream tretinoin CREAM TOPICAL 19740719 NDA NDA017522 OMP, INC. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 62032-413_9bb20969-b752-4480-a250-33d4ce285323 62032-413 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20140619 NDA AUTHORIZED GENERIC NDA022070 OMP, INC. TRETINOIN .05 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 62032-414_f9640f0b-46cd-457d-b626-413648ba5631 62032-414 HUMAN PRESCRIPTION DRUG Tretinoin Cream tretinoin CREAM TOPICAL 19880916 NDA NDA019049 OMP, INC. TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 62032-417_f9640f0b-46cd-457d-b626-413648ba5631 62032-417 HUMAN PRESCRIPTION DRUG Tretinoin Cream tretinoin CREAM TOPICAL 19730126 NDA NDA017340 OMP, INC. TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 62032-500_2f665c58-4e09-4531-903f-ad747b483d6b 62032-500 HUMAN PRESCRIPTION DRUG NU-DERM TRAVEL SET NORMAL/DRY SKIN TRANSFORMATION SYSTEM HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20041202 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-502_ae234121-7d92-4fb6-9cfc-854beee1d0dd 62032-502 HUMAN PRESCRIPTION DRUG NU-DERM STARTER SET NORMAL-OILY SKIN TRANSFORMATION SYSTEM Hydroquinone, Octinoxate, Oxybenzone and Zinc Oxide KIT 20041202 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-504_3851b75b-c31b-44f8-9341-b541cc0b39f1 62032-504 HUMAN PRESCRIPTION DRUG NU-DERM STARTER SET NORMAL-DRY SKIN TRANSFORMATION SYSTEM Hydroquinone, Octinoxate, Oxybenzone and Zinc Oxide KIT 20070820 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-507_4d112f06-a318-47da-8e30-0ca7d2d03583 62032-507 HUMAN PRESCRIPTION DRUG ROSACLEAR SYSTEM METRONIDAZOLE KIT 20121229 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-508_1456162c-eff9-4b7b-857e-08eb5a63aa86 62032-508 HUMAN PRESCRIPTION DRUG CONDITION AND ENHANCE SYSTEM TRAVEL-SIZE SURGICAL HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20070820 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-509_52e24f57-3062-4c19-902d-f98e72489b0f 62032-509 HUMAN PRESCRIPTION DRUG CONDITION AND ENHANCE SYSTEM FULL-SIZE NON-SURGICAL HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20070820 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-510_5a4e3679-60da-4c02-b325-5b7aafafb375 62032-510 HUMAN PRESCRIPTION DRUG CONDITION AND ENHANCE SYSTEM TRAVEL-SIZE NON-SURGICAL HYDROQUINONE, OCTINOXATE, AND ZINC OXIDE KIT 20070820 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-511_c048c2d1-4ebd-49dd-a8e4-0c374cd20c1e 62032-511 HUMAN OTC DRUG CLENZIDERM NORMAL TO OILY SKIN ACNE THERAPEUTIC SYSTEM SALICYLIC ACID AND BENZOYL PEROXIDE KIT 20120101 OTC MONOGRAPH FINAL part333D OMP, INC. N 20181231 62032-512_4914824e-c261-4902-aea4-39536c4ef902 62032-512 HUMAN OTC DRUG CLENZIDERM NORMAL TO DRY SKIN ACNE THERAPEUTIC SYSTEM GLYCERIN AND BENZOYL PEROXIDE KIT 20070701 OTC MONOGRAPH FINAL part333D OMP, INC. N 20181231 62032-513_76204b7d-f856-4aa7-91d3-a04432eb9254 62032-513 HUMAN PRESCRIPTION DRUG NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION Hydroquinone, Octinoxate, and Zinc Oxide KIT 20121107 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-514_53845d82-8e3c-4498-89e0-1568174f8524 62032-514 HUMAN PRESCRIPTION DRUG NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION Hydroquinone, Octinoxate,and Zinc Oxide KIT 20121107 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-515_d36cbefa-07dd-41d4-9779-95759906373b 62032-515 HUMAN PRESCRIPTION DRUG NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION TRIAL Hydroquinone, Octinoxate, and Zinc Oxide KIT 20121107 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-516_5d0f2798-b997-4b8f-932b-50778521359c 62032-516 HUMAN PRESCRIPTION DRUG NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION TRIAL Hydroquinone, Octinoxate, and Zinc Oxide KIT 20121107 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-517_ba2c32e0-568f-419b-8798-a75bc089cb2d 62032-517 HUMAN PRESCRIPTION DRUG OBAGI-C RX SYSTEM NORMAL-OILY SKIN INTERVENTION HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20121107 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-518_aba5eec8-1945-4753-b301-bc612936cec1 62032-518 HUMAN PRESCRIPTION DRUG OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20121107 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-520_1be2dfad-d98e-4b0d-9d07-4820deb8e2aa 62032-520 HUMAN PRESCRIPTION DRUG NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION Hydroquinone, Octinoxate, and Zinc Oxide KIT 20130415 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-522_25fd5bb4-16d0-408c-b0dd-5e6981f225d7 62032-522 HUMAN PRESCRIPTION DRUG NU-DERM SYSTEM NORMAL-DRY SKIN TRANSFORMATION TRIAL Hydroquinone, Octinoxate,and Zinc Oxide KIT 20130415 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-523_eef1e733-50fb-43cc-9579-0d55175e32ec 62032-523 HUMAN PRESCRIPTION DRUG OBAGI-C RX SYSTEM NORMAL-OILY SKIN INTERVENTION HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20130402 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-524_392f9428-6f3f-44ba-8719-fdf26aca7800 62032-524 HUMAN PRESCRIPTION DRUG OBAGI-C RX SYSTEM NORMAL-DRY SKIN INTERVENTION HYDROQUINONE, OCTINOXATE AND ZINC OXIDE KIT 20130402 UNAPPROVED DRUG OTHER OMP, INC. N 20181231 62032-525_49464cf1-72f1-458d-ae9d-d1a3de636623 62032-525 HUMAN OTC DRUG GENTLE REJUVENATION SYSTEM AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE KIT 20131104 OTC MONOGRAPH FINAL part352 Obagi Medical Products, Inc., a division of Valeant Pharmaceutcals North America LLC. N 20181231 62032-526_935a1c17-63d7-43ba-b02c-0736c0ca1277 62032-526 HUMAN OTC DRUG Obagi Medical - Nu-Derm System - Normal to Dry - Skin Transformation Kit OCTINOXATE, ZINC OXIDE KIT 20151210 UNAPPROVED DRUG OTHER OMP, Inc. N 20181231 62032-527_50dcfca5-cb2d-452d-a5e9-050d6561b567 62032-527 HUMAN OTC DRUG Obagi Nu-Derm FX System - Normal to Dry Octinoxate, Zinc Oxide KIT 20151104 OTC MONOGRAPH FINAL part352 OMP, Inc. N 20181231 62032-528_2b445250-ab56-4ed1-9ea3-186817d47090 62032-528 HUMAN OTC DRUG Obagi Medical - Nu-Derm System - Normal to Dry - Skin Transformation Trial Kit Octinoxate, Zinc Oxide KIT 20151116 UNAPPROVED DRUG OTHER OMP, Inc. N 20181231 62032-580_4fa39b43-7a13-47de-88d6-6398a38c9de5 62032-580 HUMAN OTC DRUG Obagi 360 Avobenzone, Octinoxate, Octisalate, Oxybenzone KIT 20150908 OTC MONOGRAPH FINAL part352 OMP, Inc. N 20181231 62032-602_fe954524-ff18-414d-989a-676a123a88c2 62032-602 HUMAN OTC DRUG NEXT CELL MEDICAL SOOTHING COMPLEX Calming Lotion Broad Spectrum SPF 25 Sunscreen LOTION TOPICAL 20180205 OTC MONOGRAPH FINAL part352 OMP, Inc. TITANIUM DIOXIDE 480 mg/mL N 20191231 62032-606_517168cf-df57-4b7f-9490-213413094f99 62032-606 HUMAN OTC DRUG NEXT CELL MEDICAL ACNE CLEANSING WIPES 2% Salicylic Acid Suitable for Oily or Acne-Prone Skin SWAB TOPICAL 20180205 OTC MONOGRAPH FINAL part333D OMP, Inc. SALICYLIC ACID 20 mg/1 N 20191231 62032-810_eebe6ed9-b55a-4e35-8dff-77a0e3108fb2 62032-810 HUMAN OTC DRUG Obagi Sun Shield MINERAL Broad Spectrum SPF 50 Sunscreen Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20151001 OTC MONOGRAPH FINAL part352 OMP, INC. TITANIUM DIOXIDE; ZINC OXIDE 4.165; 3.995 g/85g; g/85g N 20181231 62034-015_2fbe4111-2cf5-4bcd-91cc-5879b077569a 62034-015 HUMAN PRESCRIPTION DRUG clopidogrel bisulfate clopidogrel bisulfate TABLET, FILM COATED ORAL 20140214 ANDA ANDA076274 Blenheim Pharmacal, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 62034-016_cc9043ba-aa11-4fe0-ac9f-cd164e1fdcf0 62034-016 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20150227 ANDA ANDA076558 Blenheim Pharmacal, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 62034-017_74b235fb-7b6d-4d07-ba6e-3bca30e847c5 62034-017 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20160301 ANDA ANDA204165 Blenheim Pharmacal, Inc. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 62034-021_34b202a4-17c8-5300-e054-00144ff88e88 62034-021 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20160401 ANDA ANDA203088 Blenheim Pharmacal, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 62034-029_34b202a4-17c8-5300-e054-00144ff88e88 62034-029 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20160401 ANDA ANDA203088 Blenheim Pharmacal, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 62037-524_325ab4ff-87d7-444c-98f3-fa23473f4027 62037-524 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED ORAL 20040401 ANDA ANDA076604 Actavis Pharma, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 62037-559_fa1ef9a5-2882-4deb-8f77-a6ec29c93be9 62037-559 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20080825 ANDA ANDA077419 Actavis Pharma, Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 62037-560_fa1ef9a5-2882-4deb-8f77-a6ec29c93be9 62037-560 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20080825 ANDA ANDA077419 Actavis Pharma, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 62037-571_10462640-fa05-4c90-a5d7-7d6d8e3a5ac6 62037-571 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040601 ANDA ANDA076172 Actavis Pharma, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 62037-577_10462640-fa05-4c90-a5d7-7d6d8e3a5ac6 62037-577 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20050401 ANDA ANDA076869 Actavis Pharma, Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 62037-597_130bc1da-a98c-43c7-a3bc-b93f4c3a5149 62037-597 HUMAN PRESCRIPTION DRUG Cartia XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19980709 ANDA ANDA074752 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 62037-598_130bc1da-a98c-43c7-a3bc-b93f4c3a5149 62037-598 HUMAN PRESCRIPTION DRUG Cartia XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19980709 ANDA ANDA074752 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 62037-599_130bc1da-a98c-43c7-a3bc-b93f4c3a5149 62037-599 HUMAN PRESCRIPTION DRUG Cartia XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19980709 ANDA ANDA074752 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 62037-600_130bc1da-a98c-43c7-a3bc-b93f4c3a5149 62037-600 HUMAN PRESCRIPTION DRUG Cartia XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19980709 ANDA ANDA074752 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 62037-640_e961c7fa-2483-44ed-8ee6-69b16d46e881 62037-640 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20080725 ANDA ANDA075347 Actavis Pharma, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 62037-696_214d6987-4f90-4de2-9bf2-ecfed8a5bb1d 62037-696 HUMAN PRESCRIPTION DRUG TAZTIA XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 62037-697_214d6987-4f90-4de2-9bf2-ecfed8a5bb1d 62037-697 HUMAN PRESCRIPTION DRUG TAZTIA XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 62037-698_214d6987-4f90-4de2-9bf2-ecfed8a5bb1d 62037-698 HUMAN PRESCRIPTION DRUG TAZTIA XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 62037-699_214d6987-4f90-4de2-9bf2-ecfed8a5bb1d 62037-699 HUMAN PRESCRIPTION DRUG TAZTIA XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 62037-700_214d6987-4f90-4de2-9bf2-ecfed8a5bb1d 62037-700 HUMAN PRESCRIPTION DRUG TAZTIA XT Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030410 ANDA ANDA075401 Actavis Pharma, Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 62037-710_67dd8a4d-5cbc-483b-a0f9-d1207d501f3d 62037-710 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 Actavis Pharma, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 62037-720_67dd8a4d-5cbc-483b-a0f9-d1207d501f3d 62037-720 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 Actavis Pharma, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 62037-825_28537d0e-ae28-44ba-a402-2279c935d281 62037-825 HUMAN PRESCRIPTION DRUG Naproxen Sodium naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140930 ANDA ANDA075416 Actavis Pharma, Inc. NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 62037-826_28537d0e-ae28-44ba-a402-2279c935d281 62037-826 HUMAN PRESCRIPTION DRUG Naproxen Sodium naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140930 ANDA ANDA075416 Actavis Pharma, Inc. NAPROXEN SODIUM 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 62037-827_28537d0e-ae28-44ba-a402-2279c935d281 62037-827 HUMAN PRESCRIPTION DRUG Naproxen Sodium naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170501 ANDA ANDA075416 Actavis Pharma, Inc. NAPROXEN SODIUM 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 62037-830_9a6ccae7-03bf-41e2-afc6-4b99eadeb1c9 62037-830 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA077118 Actavis Pharma, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62037-831_9a6ccae7-03bf-41e2-afc6-4b99eadeb1c9 62037-831 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA076862 Actavis Pharma, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62037-832_9a6ccae7-03bf-41e2-afc6-4b99eadeb1c9 62037-832 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Actavis Pharma, Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62037-833_9a6ccae7-03bf-41e2-afc6-4b99eadeb1c9 62037-833 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Actavis Pharma, Inc. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62037-839_248729f3-44b1-4ca5-9dd5-d0846370d883 62037-839 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120127 20180531 ANDA ANDA076684 Actavis Pharma, Inc. ENOXAPARIN SODIUM 30 mg/.3mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 62037-849_248729f3-44b1-4ca5-9dd5-d0846370d883 62037-849 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120127 20180630 ANDA ANDA076684 Actavis Pharma, Inc. ENOXAPARIN SODIUM 40 mg/.4mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 62037-861_248729f3-44b1-4ca5-9dd5-d0846370d883 62037-861 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120127 20180531 ANDA ANDA076684 Actavis Pharma, Inc. ENOXAPARIN SODIUM 60 mg/.6mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 62037-862_248729f3-44b1-4ca5-9dd5-d0846370d883 62037-862 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120127 20180630 ANDA ANDA076684 Actavis Pharma, Inc. ENOXAPARIN SODIUM 80 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 62037-863_248729f3-44b1-4ca5-9dd5-d0846370d883 62037-863 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120213 20180630 ANDA ANDA076684 Actavis Pharma, Inc. ENOXAPARIN SODIUM 100 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 62037-864_248729f3-44b1-4ca5-9dd5-d0846370d883 62037-864 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120213 20180630 ANDA ANDA076684 Actavis Pharma, Inc. ENOXAPARIN SODIUM 120 mg/.8mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 62037-866_248729f3-44b1-4ca5-9dd5-d0846370d883 62037-866 HUMAN PRESCRIPTION DRUG Enoxaparin Sodium Enoxaparin Sodium INJECTION SUBCUTANEOUS 20120213 20180630 ANDA ANDA076684 Actavis Pharma, Inc. ENOXAPARIN SODIUM 150 mg/mL Heparin, Low-Molecular-Weight [Chemical/Ingredient],Low Molecular Weight Heparin [EPC] N 20191231 62037-938_b61a9cbe-8ae4-4f0f-9fbe-4bd1fe634043 62037-938 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101130 ANDA ANDA077809 Watson Pharma, Inc. CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 425.2; 574.9 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 62037-942_b61a9cbe-8ae4-4f0f-9fbe-4bd1fe634043 62037-942 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101130 ANDA ANDA077417 Watson Pharma, Inc. CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE 212.6; 287.5 mg/1; mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 62037-999_66e36a3a-bb53-4dcc-9193-0a6eeba6ad80 62037-999 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 Actavis Pharma, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 62040-1001_05fb5be5-547a-4558-8bf4-cf9d7efb007e 62040-1001 HUMAN OTC DRUG Eco Whitening HYDROGEN PEROXIDE GEL DENTAL 20140208 UNAPPROVED DRUG OTHER JN Pharm HYDROGEN PEROXIDE 8.57 g/100mL E 20171231 62040-2001_a617a4e0-2f51-4da9-8990-ba6bbd7b0159 62040-2001 HUMAN OTC DRUG E-zen Gargle CETYLPYRIDINIUM CHLORIDE LIQUID DENTAL 20140208 UNAPPROVED DRUG OTHER JN Pharm CETYLPYRIDINIUM CHLORIDE .005 g/100mL E 20171231 62041-010_0a0d3edb-8dc1-48fd-a3a2-e311cc102079 62041-010 HUMAN OTC DRUG AAPE Skin Ampoule Allantoin SOLUTION TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. ALLANTOIN .03 mg/61 E 20171231 62041-020_9bfaf0b5-2945-4b99-98ee-77caba13b6c1 62041-020 HUMAN OTC DRUG AAPE Hair Ampoule Allantoin SOLUTION TOPICAL 20140801 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. ALLANTOIN .03 mg/61 E 20171231 62041-030_1d8c3062-0b6e-4bf8-b449-07729ed95c0a 62041-030 HUMAN OTC DRUG AAPE Continuous Renewal Sun OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 Prostemics Co., Ltd. OCTINOXATE; ZINC OXIDE 4.5; 1.68 mg/60mL; mg/60mL E 20171231 62041-040_746d28d2-a3ee-48b6-a061-8af948fdd1c1 62041-040 HUMAN OTC DRUG AAPE Nutrient Facial Toner WITCH HAZEL LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. WITCH HAZEL .325 mg/130mL E 20171231 62041-050_85144b98-d0f4-4232-b293-1f1cad239257 62041-050 HUMAN OTC DRUG AAPE Continuous Renewal Serum WITCH HAZEL CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. WITCH HAZEL .2 mg/40mL E 20171231 62041-060_31437413-071a-42b7-af37-a03b10400ada 62041-060 HUMAN OTC DRUG AAPE Continuous Renewal Eye WITCH HAZEL CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. WITCH HAZEL .1 mg/20mL E 20171231 62041-070_221cfdb7-5401-4e8c-b17e-95620e0a25b9 62041-070 HUMAN OTC DRUG AAPE Continuous Renewal WITCH HAZEL CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. WITCH HAZEL .25 mg/50mL E 20171231 62041-080_596f6486-71a1-41ad-9e5d-2e47c58becca 62041-080 HUMAN OTC DRUG AAPE Continuous Renewal Mask WITCH HAZEL PATCH TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. WITCH HAZEL .15 mg/101 E 20171231 62041-090_efd507c6-9ef8-4611-860b-105431a6e40a 62041-090 HUMAN OTC DRUG AAFX Skin Allantoin SOLUTION TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. ALLANTOIN .02 mg/71 E 20171231 62041-100_e0cb40ce-f4ee-46fd-9246-b34db54dc6ba 62041-100 HUMAN OTC DRUG AAFX Hair Allantoin SOLUTION TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. ALLANTOIN .02 mg/71 E 20171231 62041-110_5b8e0f68-34e7-4b27-b3ef-a6a3c317eabe 62041-110 HUMAN OTC DRUG ditopi Body Cleanser WITCH HAZEL LIQUID TOPICAL 20150701 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. WITCH HAZEL .075 mg/300mL E 20171231 62041-120_f2affba4-fd10-4255-901a-6f90736ebd0c 62041-120 HUMAN OTC DRUG ditopi Protein DIMETHICONE LOTION TOPICAL 20150701 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. DIMETHICONE 4.5 mg/300mL E 20171231 62041-130_8fe72366-766f-4c10-8a11-2ab77f91558e 62041-130 HUMAN OTC DRUG ditopi Facial WITCH HAZEL CREAM TOPICAL 20150701 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. WITCH HAZEL .56 mg/80mL E 20171231 62041-140_158abe5e-f1d9-40c7-93cb-990561fe5b4e 62041-140 HUMAN OTC DRUG VELVET ON THE GROUND Allantoin LIQUID TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. ALLANTOIN .02 g/4mL N 20181231 62041-150_79e2f752-081a-449b-8425-e8076daa959a 62041-150 HUMAN OTC DRUG GINSENG STEMVESICLE Allantoin LIQUID TOPICAL 20160801 OTC MONOGRAPH FINAL part347 Prostemics Co., Ltd. ALLANTOIN .02 g/4mL N 20181231 62045-4333_53349de1-821e-4b4f-8df3-39f184901b66 62045-4333 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19860101 NDA NDA205865 NLR Welding Supply, Inc. OXYGEN 99 L/100L N 20191231 62045-6333_1add2055-b608-44a1-a4d9-bbf27dc105fa 62045-6333 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19860101 NDA NDA205866 NLR Welding Supply, Inc. NITROGEN 99 L/100L N 20191231 62046-001_f841e865-adfd-4efd-955d-e06364369b5d 62046-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140131 UNAPPROVED MEDICAL GAS Cook Children's Home Health OXYGEN 99 L/100L E 20171231 62049-001_3bf53088-6a8c-433c-ab01-9677d0dbd91b 62049-001 HUMAN OTC DRUG Adults Low Strength Aspirin ASPIRIN TABLET ORAL 20150601 OTC MONOGRAPH NOT FINAL part343 Genvion Corporation ASPIRIN 81 mg/1 N 20181231 62049-002_326aebcd-1efa-46b2-e054-00144ff88e88 62049-002 HUMAN OTC DRUG Adults Acetaminophen and Caffeine Pain Reliever Fever Reducer ACETAMINOPHEN, CAFFEINE TABLET ORAL 20160505 OTC MONOGRAPH NOT FINAL part343 Genvion Corporation ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 62064-011_21bc166e-a56e-4454-a905-68e54a49220a 62064-011 HUMAN PRESCRIPTION DRUG Egrifta tesamorelin KIT SUBCUTANEOUS 20140714 NDA NDA022505 Theratechnologies Inc. N 20191231 62065-514_b063dbb1-4537-4e18-b272-aa9b80d73f92 62065-514 HUMAN OTC DRUG Sport Mate Non-Alcohol Foaming Instant Hand Sanitizer HUSKY 514 SOLUTION TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 Stone Soap Company, Inc. BENZALKONIUM CHLORIDE 1 g/1000mL E 20171231 62072-456_6141678a-59e0-4c56-b726-1a22b76523a7 62072-456 HUMAN PRESCRIPTION DRUG Ammonia N 13 AMMONIA N-13 INJECTION INTRAVENOUS 20131209 ANDA ANDA203938 Kreitchman PET Center AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 62082-100_7552d738-9fbb-4c4a-bb7b-ba7e935188d3 62082-100 HUMAN OTC DRUG Arnica Montana ARNICA MONTANA PELLET TOPICAL 20140201 UNAPPROVED HOMEOPATHIC Pharmaca Integrative Pharmacy ARNICA MONTANA 30 [hp_C]/1 E 20171231 62085-1001_89106510-cd9c-4dea-aa68-8fdb164db8e6 62085-1001 HUMAN OTC DRUG GIM ASIAN GINSENG LIQUID TOPICAL 20140208 UNAPPROVED DRUG OTHER Halim Pharm Ltd ASIAN GINSENG 24 g/100mL N 20181231 62097-0003_d18001f1-79db-4872-aa07-b2a6cb142b2e 62097-0003 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19950928 UNAPPROVED MEDICAL GAS Boggs Gases div. Boggs Fire Equipment NITROGEN 99 mL/L E 20171231 62097-0006_d18001f1-79db-4872-aa07-b2a6cb142b2e 62097-0006 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 19950928 UNAPPROVED MEDICAL GAS Boggs Gases div. Boggs Fire Equipment NITROUS OXIDE 99 mL/L E 20171231 62097-9937_d18001f1-79db-4872-aa07-b2a6cb142b2e 62097-9937 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950928 UNAPPROVED MEDICAL GAS Boggs Gases div. Boggs Fire Equipment OXYGEN 99 L/100L E 20171231 62106-0097_6272dd4d-ae67-4b98-e053-2991aa0a414a 62106-0097 HUMAN OTC DRUG UNDA 270 Equisetum arvense, Hypericum perforatum CREAM TOPICAL 20150601 UNAPPROVED HOMEOPATHIC Seroyal USA HYPERICUM PERFORATUM; EQUISETUM ARVENSE TOP 1; 1 [hp_X]/40g; [hp_X]/40g N 20191231 62106-0117_58114044-283e-34c6-e053-2991aa0ac43e 62106-0117 HUMAN OTC DRUG SEPIA PLEX Aconitum napellus, Cimicifuga racemosa, Lachesis mutus, Melissa officinalis, Platinum metallicum, Sanguinaria canadensis, Sepia, Sulphuricum acidum, Valeriana officinalis LIQUID ORAL 20170403 UNAPPROVED HOMEOPATHIC Seroyal USA BLACK COHOSH; LACHESIS MUTA VENOM; PLATINUM; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; MELISSA OFFICINALIS; SULFURIC ACID; VALERIAN; ACONITUM NAPELLUS 3; 8; 8; 3; 3; 2; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-0232_25d933f6-09d5-5d03-e054-00144ff8d46c 62106-0232 HUMAN OTC DRUG THYROIDINUM 4CH Oryctolagus cuniculus (Rabbit) Thyroid Gland LIQUID ORAL 20151201 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS THYROID 4 [hp_C]/30mL N 20181231 62106-0244_0ebf9859-b488-2cc8-e054-00144ff8d46c 62106-0244 HUMAN OTC DRUG BULBINUM 4CH Oryctolagus cuniculus (Rabbit) Medulla Oblongata LIQUID ORAL 20150210 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS WHOLE 4 [hp_C]/30mL N 20181231 62106-0245_25d933f6-09c1-5d03-e054-00144ff8d46c 62106-0245 HUMAN OTC DRUG Cardinum 4CH Oryctolagus cuniculus (Rabbit) Heart LIQUID ORAL 20151201 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS HEART 4 [hp_C]/30mL N 20181231 62106-0259_26fa9493-fef3-5b1c-e054-00144ff8d46c 62106-0259 HUMAN OTC DRUG HEPATINUM 4CH Oryctolagus cuniculus (Rabbit) Liver LIQUID ORAL 20151215 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS LIVER 4 [hp_C]/30mL N 20181231 62106-0281_40cfb4b5-f747-1ab3-e054-00144ff88e88 62106-0281 HUMAN OTC DRUG Nervinum Vagum 4CH Oryctolagus cuniculus (Rabbit) Vagus Nerve LIQUID ORAL 20161108 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS PARASYMPATHETIC NERVE 4 [hp_C]/30mL N 20181231 62106-0298_26fac368-f3c2-6d49-e054-00144ff8d46c 62106-0298 HUMAN OTC DRUG RENINUM 4CH Oryctolagus cuniculus (Rabbit) Kidney LIQUID ORAL 20151215 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS KIDNEY 4 [hp_C]/30mL N 20181231 62106-0305_25d9728f-6a5f-65ab-e054-00144ff8d46c 62106-0305 HUMAN OTC DRUG SURRENINUM 200K Oryctolagus cuniculus (Rabbit) Adrenal Gland LIQUID ORAL 20151201 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS ADRENAL GLAND 200 [hp_C]/30mL N 20181231 62106-0313_40d188fc-f9fa-5c0a-e054-00144ff88e88 62106-0313 HUMAN OTC DRUG Thymusinum 4CH Oryctolagus cuniculus (Rabbit) Thymus gland LIQUID ORAL 20161108 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS THYMUS 4 [hp_C]/30mL N 20181231 62106-0601_5641f5b9-eb78-6918-e054-00144ff88e88 62106-0601 HUMAN OTC DRUG Fungisode Arsenicum album, Berberis vulgaris, Calcarea carbonica, Candida albicans, Carbo vegetabilis, Chelidonium majus, Echinacea purpurea, Hepar sulphuris calcareum, Kreosotum, Lycopodium clavatum, Mercurius solubilis, Muriaticum acidum, Nitricum acidum, Oxalicum acidum, Sepia officinalis, Sulphur LIQUID ORAL 20170802 UNAPPROVED HOMEOPATHIC Seroyal USA ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CANDIDA ALBICANS; ACTIVATED CHARCOAL; NITRIC ACID; WOOD CREOSOTE; MERCURIUS SOLUBILIS; BERBERIS VULGARIS ROOT BARK; ECHINACEA PURPUREA FLOWERING TOP; OXALIC ACID DIHYDRATE; SEPIA OFFICINALIS JUICE; SULFUR; CHELIDONIUM MAJUS ROOT; CALCIUM SULFIDE; LYCOPODIUM CLAVATUM SPORE; HYDROCHLORIC ACID 4; 8; 12; 7; 5; 5; 5; 4; 3; 8; 5; 4; 4; 5; 5; 7 [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL N 20181231 62106-0622_25665b4f-82ed-11be-e054-00144ff88e88 62106-0622 HUMAN OTC DRUG HAD Atropinum sulphuricum, Berberis vulgaris, Bryonia, Carduus marianus, Chelidonium majus, Echinacea angustifolia, Lycopodium clavatum, Magnesia phosphorica, Oryctolagus cuniculus (Rabbit) Adrenal Gland, Oryctolagus cuniculus (Rabbit) Spleen, Zingiber officinale (Ginger) Rhizome LIQUID ORAL 20151125 UNAPPROVED HOMEOPATHIC Seroyal USA ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; MILK THISTLE; CHELIDONIUM MAJUS ROOT; ECHINACEA, UNSPECIFIED; LYCOPODIUM CLAVATUM SPORE; ORYCTOLAGUS CUNICULUS ADRENAL GLAND; GINGER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ORYCTOLAGUS CUNICULUS SPLEEN 6; 3; 4; 2; 3; 2; 12; 10; 2; 6; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-0624_26d3c0c5-f83f-176b-e054-00144ff8d46c 62106-0624 HUMAN OTC DRUG HHR Arnica montana, Aurum muriaticum, Cactus grandiflorus, convallaria majalis, digitalis purpurea, oryctolagus cuniculus heart, spigelia marilandica, valeriana officinalis, veratrum album LIQUID ORAL 20151213 UNAPPROVED HOMEOPATHIC Seroyal USA GOLD TRICHLORIDE; SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; DIGITALIS; ORYCTOLAGUS CUNICULUS HEART; SPIGELIA MARILANDICA ROOT; VALERIAN; VERATRUM ALBUM ROOT; ARNICA MONTANA ROOT 6; 3; 3; 6; 10; 5; 3; 4; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-0625_26e048f5-8e88-51e6-e054-00144ff88e88 62106-0625 HUMAN OTC DRUG HKI Atropinum sulphuricum, Benzoicum acidum, Berberis vulgaris, Calcarea carbonica, Colocynthis, Coccus cacti, Lapis albus, Lithium carbonicum, Lycopodium clavatum, Oryctolagus cuniculus kidney, Rubia tinctorum, Sarsaparilla, Urtica urens LIQUID ORAL 20151214 UNAPPROVED HOMEOPATHIC Seroyal USA BENZOIC ACID; PROTORTONIA CACTI; LITHIUM CARBONATE; RUBIA TINCTORUM ROOT; URTICA URENS; BERBERIS VULGARIS ROOT BARK; ATROPINE SULFATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CITRULLUS COLOCYNTHIS FRUIT PULP; LYCOPODIUM CLAVATUM SPORE; ORYCTOLAGUS CUNICULUS KIDNEY; SMILAX REGELII ROOT; CALCIUM HEXAFLUOROSILICATE 6; 5; 6; 4; 1; 5; 6; 12; 6; 5; 10; 1; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL N 20181231 62106-0626_2f1d6e56-b79a-486e-e054-00144ff88e88 62106-0626 HUMAN OTC DRUG HLU PNEUMO DROPS Arsenicum iodatum, Calcarea phosphorica, Carbo vegetabilis, Oryctolagus cuniculus lung, Phellandrium aquaticum, Silicea, Stannum metallicum, Sulphur, Thymus vulgaris LIQUID ORAL 20160327 UNAPPROVED HOMEOPATHIC Seroyal USA SILICON DIOXIDE; TIN; SULFUR; TRIBASIC CALCIUM PHOSPHATE; ARSENIC TRIIODIDE; ACTIVATED CHARCOAL; ORYCTOLAGUS CUNICULUS LUNG; OENANTHE AQUATICA FRUIT; THYME 12; 10; 12; 10; 7; 12; 10; 5; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-0628_43048cc4-fc36-114a-e054-00144ff8d46c 62106-0628 HUMAN OTC DRUG HLIP Atropinum sulphuricum, Bryonia alba, Berberis vulgaris, Carduus marianus, Chelidonium majus, Leptandra virginica, Lycopodium clavatum, Magnesia muriatica, Natrum muriaticum, Natrum sulphuricum, Oryctolagus cuniculus, Zingiber officinale LIQUID ORAL 20161206 UNAPPROVED HOMEOPATHIC Seroyal USA BERBERIS VULGARIS ROOT BARK; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS ROOT; CULVER'S ROOT; GINGER; MILK THISTLE; LYCOPODIUM CLAVATUM SPORE; ORYCTOLAGUS CUNICULUS LIVER; ATROPINE SULFATE 4; 4; 5; 6; 6; 4; 3; 2; 2; 12; 10; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-0629_525694c5-4216-6e87-e054-00144ff8d46c 62106-0629 HUMAN OTC DRUG HPNP Berberis vulgaris, Chelidonium majus, Kreosotum, Natrum sulphuricum, Oryctolagus cuniculus Kidney, Oryctolagus cuniculus Pancreatin, Phosphoricum acidum, Syzygium jambolanum, Vaccinium myrtillus LIQUID ORAL 20170619 UNAPPROVED HOMEOPATHIC Seroyal USA SODIUM SULFATE; ORYCTOLAGUS CUNICULUS KIDNEY; PHOSPHORIC ACID; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS ROOT; WOOD CREOSOTE; ORYCTOLAGUS CUNICULUS PANCREATIN; SYZYGIUM CUMINI FRUIT; BILBERRY 6; 10; 4; 2; 4; 6; 10; 10; 2 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-0630_23078896-9619-084c-e054-00144ff88e88 62106-0630 HUMAN OTC DRUG HPTP Arnica montana, Achillea millefolium, Erigeron canadensis, Hydrastis canadensis, Oryctolagus cuniculus, Sabina, Secale cornutum LIQUID ORAL 20151026 UNAPPROVED HOMEOPATHIC Seroyal USA JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; ARNICA MONTANA ROOT; ACHILLEA MILLEFOLIUM; CONYZA CANADENSIS; GOLDENSEAL; ORYCTOLAGUS CUNICULUS PITUITARY GLAND; ORYCTOLAGUS CUNICULUS ADRENAL GLAND 8; 8; 6; 6; 6; 6; 10; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-0631_079bede5-f619-03ed-e054-00144ff8d46c 62106-0631 HUMAN OTC DRUG HTHY Calcarea carbonica, Calcarea iodata, Ferrum iodatum, Fucus vesiculosus, Hepar sulphuris calcareum, Kali iodatum, Lapis albus Calcium Fluosilicate, Oryctolagus cuniculus (Rabbit) Adrenal Gland, Oryctolagus cuniculus (Rabbit) Pituitary Gland, Oryctolagus cuniculus (Rabbit) Spleen, Oryctolagus cuniculus (Rabbit) Thymus Gland, Oryctolagus cuniculus (Rabbit) Thyroid Gland, Spongia tosta LIQUID ORAL 20151127 UNAPPROVED HOMEOPATHIC Seroyal USA OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM IODIDE; FERROUS IODIDE; FUCUS VESICULOSUS; CALCIUM SULFIDE; CALCIUM HEXAFLUOROSILICATE; ORYCTOLAGUS CUNICULUS ADRENAL GLAND; ORYCTOLAGUS CUNICULUS PITUITARY GLAND; ORYCTOLAGUS CUNICULUS SPLEEN; ORYCTOLAGUS CUNICULUS THYMUS; SPONGIA OFFICINALIS SKELETON, ROASTED; POTASSIUM IODIDE; ORYCTOLAGUS CUNICULUS THYROID 8; 4; 6; 6; 8; 6; 10; 10; 10; 10; 6; 6; 10 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-0632_25c9982b-2bca-4b75-e054-00144ff8d46c 62106-0632 HUMAN OTC DRUG HTYP Arsenicum album, Belladonna, Calcarea fluorica, Calcarea sulphurica, Echinacea angustifolia, Hepar sulphuris calcareum, Nux moschata, Oryctolagus cuniculus thymus Gland, Silicea, Sulphur iodatum LIQUID ORAL 20151130 UNAPPROVED HOMEOPATHIC Seroyal USA ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; CALCIUM SULFIDE; ORYCTOLAGUS CUNICULUS THYMUS; SILICON DIOXIDE; SULFUR IODIDE; ECHINACEA, UNSPECIFIED; NUTMEG 6; 6; 6; 4; 8; 10; 6; 6; 1; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-0744_1594966e-4ab4-3caa-e054-00144ff88e88 62106-0744 HUMAN OTC DRUG Fucus Complex Fucus vesiculosus, spongia tosta, Badiaga LIQUID SUBLINGUAL 20150508 UNAPPROVED HOMEOPATHIC Seroyal USA SPONGIA OFFICINALIS SKELETON, ROASTED; SPONGILLA LACUSTRIS; FUCUS VESICULOSUS 2; 3; 1 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 62106-0902_56b87cfb-016f-141d-e054-00144ff88e88 62106-0902 HUMAN OTC DRUG CIMICIFUGA PLEX Caulophyllum thalictroides, Cimicifuga racemosa, Cuprum metallicum, Folliculinum, Gossypium herbaceum, Histaminum hydrochloricum, Hypothalamus, Hypophysis cerebri, Magnesia phosphorica, Platinum metallicum, Sepia, Thyroidinum LIQUID ORAL 20170814 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS THYROID; SEPIA OFFICINALIS JUICE; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; COPPER; ESTRONE; GOSSYPIUM HERBACEUM ROOT BARK; HISTAMINE DIHYDROCHLORIDE; ORYCTOLAGUS CUNICULUS HYPOTHALAMUS; ORYCTOLAGUS CUNICULUS PITUITARY GLAND; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PLATINUM 14; 10; 10; 10; 10; 15; 10; 15; 14; 14; 10; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-1050_3399cc79-569a-3caf-e054-00144ff8d46c 62106-1050 HUMAN OTC DRUG CALCAREA FLUORICA 6X Calcium Fluoride TABLET SUBLINGUAL 20150210 UNAPPROVED HOMEOPATHIC Seroyal USA CALCIUM FLUORIDE 6 [hp_X]/1 N 20181231 62106-1051_5785e14e-20f1-2034-e053-2991aa0a3d8d 62106-1051 HUMAN OTC DRUG CALCAREA PHOSPHORICA 6X Calcium hydrogen phosphate dihydrate TABLET SUBLINGUAL 20150120 UNAPPROVED HOMEOPATHIC Seroyal USA TRIBASIC CALCIUM PHOSPHATE 6 [hp_X]/1 N 20181231 62106-1052_58250ce3-b477-493e-e053-2a91aa0a4fef 62106-1052 HUMAN OTC DRUG CALCAREA SULFURICA 6X Calcium Sulfate TABLET SUBLINGUAL 20170901 UNAPPROVED HOMEOPATHIC Seroyal USA CALCIUM SULFATE ANHYDROUS 6 [hp_X]/1 N 20181231 62106-1053_38c6f06f-c2d1-2a3d-e054-00144ff88e88 62106-1053 HUMAN OTC DRUG FERRUM PHOSPHORICUM 6X Hydrated iron III phosphate TABLET SUBLINGUAL 20150430 UNAPPROVED HOMEOPATHIC Seroyal USA FERROSOFERRIC PHOSPHATE 6 [hp_X]/1 N 20181231 62106-1054_22cbba5d-a783-4118-e054-00144ff88e88 62106-1054 HUMAN OTC DRUG KALIUM MURIATICUM 6X Potassium Chloride TABLET SUBLINGUAL 20151023 UNAPPROVED HOMEOPATHIC Seroyal USA POTASSIUM CHLORIDE 6 [hp_X]/1 N 20181231 62106-1055_38c6f06f-c2d1-2a3d-e054-00144ff88e88 62106-1055 HUMAN OTC DRUG KALIUM PHOSPHORICUM 6X Potassium dihydrogen phosphate TABLET SUBLINGUAL 20150501 UNAPPROVED HOMEOPATHIC Seroyal USA POTASSIUM PHOSPHATE, MONOBASIC 6 [hp_X]/1 N 20181231 62106-1057_5785e14e-20f1-2034-e053-2991aa0a3d8d 62106-1057 HUMAN OTC DRUG MAGNESIA PHOSPHORICA 6x Magnesium hydrogen phosphate trihydrate TABLET SUBLINGUAL 20150120 UNAPPROVED HOMEOPATHIC Seroyal USA MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X]/1 N 20181231 62106-1058_38c9c653-bc25-613c-e054-00144ff8d46c 62106-1058 HUMAN OTC DRUG Natrium Muriaticum 6X Sodium chloride TABLET SUBLINGUAL 20150210 UNAPPROVED HOMEOPATHIC Seroyal USA SODIUM CHLORIDE 6 [hp_X]/1 N 20181231 62106-1059_57867cd1-6df2-dbe8-e053-2a91aa0a3df8 62106-1059 HUMAN OTC DRUG NATRIUM PHOSPHORICUM 6X Sodium Phosphate TABLET SUBLINGUAL 20151023 UNAPPROVED HOMEOPATHIC Seroyal USA SODIUM PHOSPHATE 6 [hp_X]/1 N 20181231 62106-1060_38c6f06f-c2d1-2a3d-e054-00144ff88e88 62106-1060 HUMAN OTC DRUG NATRIUM SULFURICUM 6X Anhydrous sodium sulfate TABLET SUBLINGUAL 20150501 UNAPPROVED HOMEOPATHIC Seroyal USA SODIUM SULFATE 6 [hp_X]/1 N 20181231 62106-1061_38c9ce2c-8bf8-1895-e054-00144ff88e88 62106-1061 HUMAN OTC DRUG SILICEA 6X Silicea TABLET SUBLINGUAL 20150506 UNAPPROVED HOMEOPATHIC Seroyal USA SILICON DIOXIDE 6 [hp_X]/1 N 20181231 62106-1062_5785e14e-20f1-2034-e053-2991aa0a3d8d 62106-1062 HUMAN OTC DRUG CALCAREA CARBONICA 6X Impure calcium carbonate TABLET SUBLINGUAL 20150120 UNAPPROVED HOMEOPATHIC Seroyal USA OYSTER SHELL CALCIUM CARBONATE, CRUDE 6 [hp_X]/1 N 20181231 62106-1100_445b2cbd-0710-34b5-e054-00144ff88e88 62106-1100 HUMAN OTC DRUG Unda 1 ACHILLEA MILLEFOLIUM LIQUID ORAL 20140701 UNAPPROVED HOMEOPATHIC Seroyal USA ACHILLEA MILLEFOLIUM; ARCTOSTAPHYLOS UVA-URSI LEAF; VALERIAN; ANGELICA ARCHANGELICA ROOT; EQUISETUM ARVENSE TOP; LYCOPODIUM CLAVATUM SPORE; LARIX DECIDUA RESIN; SILVER 4; 4; 4; 4; 4; 4; 5; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1101_5a950ca4-3522-9120-e053-2991aa0aacb2 62106-1101 HUMAN OTC DRUG UNDA 2 Petroselinum sativum, Rhamnus frangula, Thlaspi bursa-pastoris, Juniperus communis, Asparagus officinalis, Berberis vulgaris, Genista tinctoria, Argentum metallicum LIQUID ORAL 20150526 UNAPPROVED HOMEOPATHIC Seroyal USA BERBERIS VULGARIS ROOT BARK; PETROSELINUM CRISPUM; ASPARAGUS; FRANGULA ALNUS BARK; CAPSELLA BURSA-PASTORIS; SILVER; GENISTA TINCTORIA; JUNIPER BERRY 4; 4; 4; 4; 4; 12; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1102_6281a71d-04c8-2614-e053-2991aa0a6b4d 62106-1102 HUMAN OTC DRUG Unda 3 Equisetum arvense stem, Chamomilla, Condurango Bark, Viola tricolor, Boldo Leaf, Aluminium metallicum, Stannum metallicum LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC Seroyal USA EQUISETUM ARVENSE TOP; MATRICARIA RECUTITA; MARSDENIA CONDURANGO BARK; VIOLA TRICOLOR; PEUMUS BOLDUS LEAF; ALUMINUM; TIN 4; 4; 4; 4; 4; 12; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1103_4c628182-432b-50e9-e054-00144ff88e88 62106-1103 HUMAN OTC DRUG UNDA 4 Laurus nobilis, Condurango, Rhamnus frangula, Menyanthes trifoliata, Absinthium, Jateorhiza palmata, Argentum metallicum, Antimonium crudum LIQUID ORAL 20150601 UNAPPROVED HOMEOPATHIC Seroyal USA FRANGULA ALNUS BARK; MENYANTHES TRIFOLIATA; WORMWOOD; JATEORHIZA CALUMBA ROOT; SILVER; ANTIMONY TRISULFIDE; BAY LEAF; MARSDENIA CONDURANGO BARK 4; 4; 4; 4; 12; 12; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1104_5a9707c1-4e86-c4c6-e053-2a91aa0a6ef6 62106-1104 HUMAN OTC DRUG UNDA 5 Tormentilla, Tussilago farfara, Adiantum capillus-veneris, Glycyrrhiza glabra, Drosera, Grindelia, Inula helenium, Cuprum metallicum, Argentum metallicum LIQUID ORAL 20150602 UNAPPROVED HOMEOPATHIC Seroyal USA POTENTILLA ERECTA ROOT; ADIANTUM CAPILLUS-VENERIS LEAF; DROSERA ROTUNDIFOLIA FLOWERING TOP; GLYCYRRHIZA GLABRA; GRINDELIA HIRSUTULA FLOWERING TOP; INULA HELENIUM ROOT; COPPER; SILVER; TUSSILAGO FARFARA WHOLE 4; 4; 4; 4; 4; 4; 12; 12; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1105_5a950ca4-3522-9120-e053-2991aa0aacb2 62106-1105 HUMAN OTC DRUG UNDA 6 Senna Leaflet, Rhamnus frangula Bark, Carum carvi, Foeniculum vulgare, Illicium verum, Rhamnus cathartica, Argentum metallicum LIQUID ORAL 20150526 UNAPPROVED HOMEOPATHIC Seroyal USA SENNA LEAF; FRANGULA ALNUS BARK; CARAWAY SEED; FENNEL SEED; ILLICIUM VERUM WHOLE; RHAMNUS CATHARTICA FRUIT; SILVER 4; 4; 4; 4; 4; 4; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1106_6281a71d-04c8-2614-e053-2991aa0a6b4d 62106-1106 HUMAN OTC DRUG Unda 7 Equisetum arvense, Uva-ursi, Juniperus communis, Cytisus scoparius, Hieraciumpilosella, Argentum metallicum LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC Seroyal USA HIERACIUM PILOSELLA WHOLE; EQUISETUM ARVENSE TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; JUNIPERUS COMMUNIS WHOLE; CYTISUS SCOPARIUS FLOWERING TOP; SILVER 4; 4; 4; 4; 4; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1107_5a9707c1-4e86-c4c6-e053-2a91aa0a6ef6 62106-1107 HUMAN OTC DRUG UNDA 8 Hamamelis virginiana, Millefolium, Equisetum arvense, Mercurialis perennis, Thlaspi bursa-pastoris, Cactus grandiflorus, Crataegus, Cuprum metallicum LIQUID ORAL 20150602 UNAPPROVED HOMEOPATHIC Seroyal USA HAMAMELIS VIRGINIANA BARK; MERCURIALIS PERENNIS; CRATAEGUS FRUIT; COPPER; ACHILLEA MILLEFOLIUM; EQUISETUM ARVENSE BRANCH; CAPSELLA BURSA-PASTORIS; SELENICEREUS GRANDIFLORUS STEM 4; 4; 4; 12; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1108_5a950ca4-3522-9120-e053-2991aa0aacb2 62106-1108 HUMAN OTC DRUG UNDA 9 Mentha piperita, Melissa officinalis, Salvia pratensis, Thymus vulgaris, Valeriana officinalis, Aurum metallicum, Plumbum metallicum LIQUID ORAL 20150527 UNAPPROVED HOMEOPATHIC Seroyal USA GOLD; THYMUS VULGARIS WHOLE; VALERIAN; LEAD; MENTHA PIPERITA; MELISSA OFFICINALIS; SALVIA PRATENSIS LEAF 12; 4; 4; 12; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1109_5aa64b40-ffa9-3f0a-e053-2991aa0a55c8 62106-1109 HUMAN OTC DRUG UNDA 10 Absinthium, Argentum metallicum, Equisetum arvense, Juniperus communis, Millefolium, Rhamnus frangula LIQUID ORAL 20150929 UNAPPROVED HOMEOPATHIC Seroyal USA WORMWOOD; SILVER; EQUISETUM ARVENSE BRANCH; JUNIPER BERRY; ACHILLEA MILLEFOLIUM; FRANGULA ALNUS BARK 4; 12; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1110_4459a44a-df27-5589-e054-00144ff8d46c 62106-1110 HUMAN OTC DRUG Unda 11 Asparagus officinalis Young Shoot, Mentha piperita Whole Plant, Millefolium Whole Plant,Thymus serpyllum Whole Plant, Crocus sativus Dried Stigma, Rosmarinus officinalis Flowering Twigs, Glechoma hederacea Whole Plant, Verbena officinalis Whole Plant, Uva-ursi Leaf, Cuprum metallicum LIQUID ORAL 20150224 UNAPPROVED HOMEOPATHIC Seroyal USA ACHILLEA MILLEFOLIUM; THYMUS SERPYLLUM; SAFFRON; ROSMARINUS OFFICINALIS FLOWERING TOP; VERBENA OFFICINALIS; COPPER; ASPARAGUS; GLECHOMA HEDERACEA; ARCTOSTAPHYLOS UVA-URSI LEAF; MENTHA PIPERITA 4; 4; 4; 4; 4; 12; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1112_0a6be318-a46a-385b-e054-00144ff8d46c 62106-1112 HUMAN OTC DRUG Unda 13 Boldo Leaf, Ricinus communis Seed, Combretum raimbaultii Leaf, Jateorhiza palmata Root, Argentum metallicum LIQUID ORAL 20141217 UNAPPROVED HOMEOPATHIC Seroyal USA SILVER; PEUMUS BOLDUS LEAF; RICINUS COMMUNIS SEED; COMBRETUM MICRANTHUM LEAF; JATEORHIZA CALUMBA ROOT 12; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1113_5a9707c1-4e86-c4c6-e053-2a91aa0a6ef6 62106-1113 HUMAN OTC DRUG UNDA 14 Eucalyptus globulus, Inula helenium, Jateorhiza palmata, Camphora, Argentum metallicum, Aurum metallicum, Cuprum metallicum LIQUID ORAL 20150602 UNAPPROVED HOMEOPATHIC Seroyal USA INULA HELENIUM ROOT; JATEORHIZA CALUMBA ROOT; CAMPHOR (NATURAL); SILVER; GOLD; COPPER; EUCALYPTUS GLOBULUS LEAF 4; 4; 4; 12; 12; 12; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1114_628151e8-80a8-7e69-e053-2a91aa0af3d2 62106-1114 HUMAN OTC DRUG UNDA 15 Allium cepa, Aurum metallicum, Eucalyptus globulus, Inula helenium, Trigonella foenum-graecum LIQUID ORAL 20150525 UNAPPROVED HOMEOPATHIC Seroyal USA ONION; GOLD; EUCALYPTUS GLOBULUS LEAF; INULA HELENIUM ROOT; FENUGREEK SEED 4; 12; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1115_6281a71d-04c8-2614-e053-2991aa0a6b4d 62106-1115 HUMAN OTC DRUG Unda 16 Saxifraga granulata, Origanum vulgare, Lactuca virosa, Veronica officinalis, Ajuga reptans, Drosera, Senega officinalis, Aurum metallicum, Argentum metallicum LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC Seroyal USA VERONICA OFFICINALIS FLOWERING TOP; AJUGA REPTANS WHOLE; DROSERA ROTUNDIFOLIA FLOWERING TOP; POLYGALA SENEGA ROOT; GOLD; SAXIFRAGA GRANULATA WHOLE; ORIGANUM VULGARE SUBSP. HIRTUM WHOLE; LACTUCA VIROSA; SILVER 4; 4; 4; 4; 12; 4; 4; 4; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1116_445b2cbd-06f9-34b5-e054-00144ff88e88 62106-1116 HUMAN OTC DRUG Unda 17 Jateorhiza palmata, Boldo Leaf, Rhamnus frangula, Scabiosa succisa Underground Parts, Valeriana officinalis, Dulcamara, Rumex crispus, Argentum metallicum LIQUID ORAL 20150206 UNAPPROVED HOMEOPATHIC Seroyal USA JATEORHIZA CALUMBA ROOT; PEUMUS BOLDUS LEAF; FRANGULA ALNUS BARK; VALERIAN; CHAMAELIRIUM LUTEUM ROOT; SOLANUM DULCAMARA STEM; RUMEX CRISPUS ROOT; SILVER 4; 4; 4; 4; 4; 4; 4; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1117_2f1030b6-86bf-09b0-e054-00144ff8d46c 62106-1117 HUMAN OTC DRUG Unda 18 Condurango, Lycopodium clavatum, Viburnum prunifolium, Thuja occidentalis, Camphora, Cuprum metallicum, Aluminium metallicum, Stibium metallicum LIQUID ORAL 20150206 UNAPPROVED HOMEOPATHIC Seroyal USA ANTIMONY; MARSDENIA CONDURANGO BARK; VIBURNUM PRUNIFOLIUM BARK; THUJA OCCIDENTALIS LEAFY TWIG; CINNAMOMUM CAMPHORA WHOLE; COPPER; LYCOPODIUM CLAVATUM SPORE; ALUMINUM 12; 5; 5; 5; 9; 12; 5; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1118_4c47f5cd-fcb4-3ecb-e054-00144ff8d46c 62106-1118 HUMAN OTC DRUG UNDA 19 Aluminium metallicum, Drosera, Illicium verum, Mentha piperita, Senega officinalis LIQUID ORAL 20170403 UNAPPROVED HOMEOPATHIC Seroyal USA ALUMINUM; STAR ANISE FRUIT; POLYGALA SENEGA ROOT; DROSERA ROTUNDIFOLIA FLOWERING TOP; PEPPERMINT 12; 3; 4; 5; 5 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1119_628151e8-80a8-7e69-e053-2a91aa0af3d2 62106-1119 HUMAN OTC DRUG UNDA 20 Aluminium metallicum, Argentum metallicum, Arsenicum album, Aurum metallicum, Calendula officinalis, Condurango, Jacaranda caroba, Robinia pseudoacacia, Sabina LIQUID ORAL 20150525 UNAPPROVED HOMEOPATHIC Seroyal USA ALUMINUM; SILVER; ARSENIC TRIOXIDE; GOLD; CALENDULA OFFICINALIS FLOWERING TOP; MARSDENIA CONDURANGO BARK; JACARANDA CAROBA LEAF; ROBINIA PSEUDOACACIA BARK; JUNIPERUS SABINA LEAF 12; 12; 12; 12; 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1120_628151e8-80a8-7e69-e053-2a91aa0af3d2 62106-1120 HUMAN OTC DRUG UNDA 21 Condurango, Calendula officinalis, Camphora, Hydrastis canadensis, Thuja occidentalis, Aluminium metallicum, Aurum metallicum LIQUID ORAL 20150526 UNAPPROVED HOMEOPATHIC Seroyal USA MARSDENIA CONDURANGO BARK; CALENDULA OFFICINALIS FLOWERING TOP; CAMPHOR (NATURAL); GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG; ALUMINUM; GOLD 4; 4; 4; 4; 4; 12; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1121_5aa77082-8c23-ab16-e053-2991aa0abcfd 62106-1121 HUMAN OTC DRUG UNDA 22 Absinthium, Aconitum napellus, Argentum metallicum, Boldo Leaf, Chamomilla, Coffea tosta, Jateorhiza palmata, Manganum oxydatum nigrum, Salvia officinalis LIQUID ORAL 20150921 UNAPPROVED HOMEOPATHIC Seroyal USA MANGANESE DIOXIDE; SAGE; PEUMUS BOLDUS LEAF; MATRICARIA RECUTITA; JATEORHIZA CALUMBA ROOT; WORMWOOD; ACONITUM NAPELLUS; SILVER; COFFEA ARABICA SEED, ROASTED 12; 4; 4; 4; 4; 4; 4; 12; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1122_26e6ed42-2104-5968-e054-00144ff88e88 62106-1122 HUMAN OTC DRUG Unda 23 Equisetum arvense, Hypericum perforatum, Nux vomica, Quercus robur, Tormentilla, LIQUID ORAL 20151214 UNAPPROVED HOMEOPATHIC Seroyal USA STRYCHNOS NUX-VOMICA SEED; QUERCUS ROBUR TWIG BARK; EQUISETUM ARVENSE BRANCH; HYPERICUM PERFORATUM; POTENTILLA ERECTA ROOT 6; 6; 5; 5; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1123_5aa7a7da-c706-fccd-e053-2991aa0a02fb 62106-1123 HUMAN OTC DRUG Unda 24 Crataegus Fruit, Passiflora incarnata, Boldo Leaf, Valeriana officinalis Root, Chamomilla, Aluminium metallicum LIQUID ORAL 20150224 UNAPPROVED HOMEOPATHIC Seroyal USA PEUMUS BOLDUS LEAF; CRATAEGUS FRUIT; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; MATRICARIA RECUTITA; ALUMINUM 4; 4; 4; 4; 4; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1124_5aa77082-8c23-ab16-e053-2991aa0abcfd 62106-1124 HUMAN OTC DRUG UNDA 25 Argentum metallicum, Crataegus, Gelsemium sempervirens, Hamamelis virginiana, Magnolia grandiflora, Spiraea ulmaria, Stannum metallicum, Valeriana officinalis LIQUID ORAL 20150921 UNAPPROVED HOMEOPATHIC Seroyal USA SILVER; FILIPENDULA ULMARIA ROOT; CRATAEGUS FRUIT; TIN; VALERIAN; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA BARK; MAGNOLIA GRANDIFLORA FLOWER 12; 4; 4; 12; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1125_0fdad876-04c7-13b3-e054-00144ff88e88 62106-1125 HUMAN OTC DRUG Unda 26 Myrtus communis, Apis mellifica, Argentum metallicum LIQUID ORAL 20150224 UNAPPROVED HOMEOPATHIC Seroyal USA MYRTUS COMMUNIS TOP; APIS MELLIFERA; SILVER 4; 4; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1126_5aa77082-8c23-ab16-e053-2991aa0abcfd 62106-1126 HUMAN OTC DRUG UNDA 27 Antimonium crudum, Borago officinalis, Cetraria islandica, Drosera, Mentha piperita, Senega officinalis LIQUID ORAL 20150921 UNAPPROVED HOMEOPATHIC Seroyal USA ANTIMONY TRISULFIDE; BORAGE; CETRARIA ISLANDICA SUBSP. ISLANDICA; DROSERA ROTUNDIFOLIA FLOWERING TOP; MENTHA PIPERITA; POLYGALA SENEGA ROOT 12; 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1127_5aa7289a-9987-47be-e053-2991aa0ad7b0 62106-1127 HUMAN OTC DRUG UNDA 28 Lactuca virosa, Taraxacum officinale, Sarsaparilla, Spiraea ulmaria, Condurango, Aluminium metallicum, Cuprum metallicum, Stannum metallicum LIQUID ORAL 20150610 UNAPPROVED HOMEOPATHIC Seroyal USA SARSAPARILLA; FILIPENDULA ULMARIA ROOT; ALUMINUM; COPPER; TIN; MARSDENIA CONDURANGO BARK; TARAXACUM OFFICINALE WHOLE; LACTUCA VIROSA 4; 4; 12; 12; 12; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1128_244cdf03-ac0d-2505-e054-00144ff88e88 62106-1128 HUMAN OTC DRUG UNDA 29 Absinthium, Allium cepa, Argentum metallicum, Betula pendula Sap, Lamium album, Salvia officinalis LIQUID ORAL 20150921 UNAPPROVED HOMEOPATHIC Seroyal USA LAMIUM ALBUM; WORMWOOD; ONION; SILVER; BETULA PENDULA WOOD; SAGE 4; 4; 4; 12; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1129_4c613cdd-fb06-3185-e054-00144ff88e88 62106-1129 HUMAN OTC DRUG Unda 30 Glechoma hederacea, Jateorhiza palmata, Lactuca virosa, Plumbum metallicum, Sempervivum tectorum, Taraxacum officinale, Valeriana officinalis LIQUID ORAL 20151214 UNAPPROVED HOMEOPATHIC Seroyal USA LACTUCA VIROSA; LEAD; SEMPERVIVUM TECTORUM LEAF; VALERIAN; GLECHOMA HEDERACEA; JATEORHIZA CALUMBA ROOT; TARAXACUM OFFICINALE WHOLE 4; 12; 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1130_2f1dbbc3-b6ba-3758-e054-00144ff8d46c 62106-1130 HUMAN OTC DRUG UNDA 31 Argentum metallicum, Camphora, Carduus benedictus, Juniperus communis, Lappa major, Robinia pseudoacacia LIQUID ORAL 20160327 UNAPPROVED HOMEOPATHIC Seroyal USA SILVER; CINNAMOMUM CAMPHORA WHOLE; CENTAUREA BENEDICTA; JUNIPERUS COMMUNIS WHOLE; ARCTIUM LAPPA ROOT; ROBINIA PSEUDOACACIA BARK 12; 12; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1131_3d1dabe8-2b1c-52dd-e054-00144ff88e88 62106-1131 HUMAN OTC DRUG UNDA 32 Aconitum napellus, Argentum metallicum,Borago officinalis, Camphora, Grindelia, Stannum metallicum LIQUID ORAL 20160922 UNAPPROVED HOMEOPATHIC Seroyal USA SILVER; TIN; ACONITUM NAPELLUS; BORAGE; GRINDELIA HIRSUTULA FLOWERING TOP; CAMPHOR (NATURAL) 12; 12; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1132_5abb7f48-1905-79b9-e053-2a91aa0a8138 62106-1132 HUMAN OTC DRUG Unda 33 Allium cepa, Tilia europaea, Jateorhiza palmata, Viola tricolor, Boldo Leaf, Anacardium orientale Frui, Aluminium metallicum LIQUID ORAL 20150206 UNAPPROVED HOMEOPATHIC Seroyal USA ONION; TILIA X EUROPAEA FLOWER; JATEORHIZA CALUMBA ROOT; VIOLA TRICOLOR; PEUMUS BOLDUS LEAF; SEMECARPUS ANACARDIUM JUICE; ALUMINUM 4; 4; 4; 4; 4; 4; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1133_5aa7289a-9987-47be-e053-2991aa0ad7b0 62106-1133 HUMAN OTC DRUG UNDA 34 Humulus lupulus, Juniperus communis, Equisetum arvense, Hydrastis canadensis, Syzygium jambolanum, Aurum metallicum LIQUID ORAL 20150610 UNAPPROVED HOMEOPATHIC Seroyal USA HOPS; JUNIPERUS COMMUNIS WHOLE; EQUISETUM ARVENSE BRANCH; GOLDENSEAL; SYZYGIUM CUMINI SEED; GOLD 4; 4; 4; 4; 4; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1134_445b9116-e350-5720-e054-00144ff88e88 62106-1134 HUMAN OTC DRUG UNDA 35 Aurum metallicum, Corallium rubrum Exoskeleton, Crataegus, Grindelia, Hamamelis virginiana, Mentha piperita, Myrtus communis LIQUID ORAL 20150910 UNAPPROVED HOMEOPATHIC Seroyal USA GOLD; CORALLIUM RUBRUM EXOSKELETON; CRATAEGUS FRUIT; GRINDELIA HIRSUTULA FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MENTHA PIPERITA; MYRTUS COMMUNIS TOP 12; 12; 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1135_26e7d64b-1a95-6de4-e054-00144ff8d46c 62106-1135 HUMAN OTC DRUG Unda 36 Aconitum napellus, Aesculus hippocastanum, Aluminium metallicum, Chelidonium majus, Hamamelis virginiana, Hydrastis canadensis, Hypericum perforatum LIQUID ORAL 20151214 UNAPPROVED HOMEOPATHIC Seroyal USA ACONITUM NAPELLUS; HORSE CHESTNUT; ALUMINUM; CHELIDONIUM MAJUS ROOT; HAMAMELIS VIRGINIANA BARK; GOLDENSEAL; HYPERICUM PERFORATUM 4; 4; 12; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1136_5aa7a11e-e8cc-f333-e053-2991aa0a72ad 62106-1136 HUMAN OTC DRUG Unda 37 Petroselinum sativum, Calendula officinalis, Dulcamara, Lycopodium clavatum, Hypericum perforatum, Aurum metallicum, Argentummetallicum LIQUID ORAL 20150116 UNAPPROVED HOMEOPATHIC Seroyal USA SOLANUM DULCAMARA STEM; HYPERICUM PERFORATUM; GOLD; PETROSELINUM CRISPUM; CALENDULA OFFICINALIS FLOWERING TOP; SILVER; LYCOPODIUM CLAVATUM SPORE 4; 4; 12; 4; 4; 12; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1137_244cdf03-ac0d-2505-e054-00144ff88e88 62106-1137 HUMAN OTC DRUG UNDA 38 Aluminium metallicum, Argentum metallicum, Inula helenium, Sarsaparilla, Stigmata maidis, Valeriana officinalis LIQUID ORAL 20150921 UNAPPROVED HOMEOPATHIC Seroyal USA ALUMINUM; SILVER; INULA HELENIUM ROOT; SARSAPARILLA; CORN SILK; VALERIAN 12; 12; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1138_4c617477-b972-1ce7-e054-00144ff8d46c 62106-1138 HUMAN OTC DRUG Unda 39 Asafoetida Gum Resin,Absinthium, Allium cepa, Tanacetum vulgare Aerial Parts, Cina Flower-heads, Dryopteris filix-mas Rhizome, Argentum metallicum LIQUID ORAL 20150116 UNAPPROVED HOMEOPATHIC Seroyal USA DRYOPTERIS FILIX-MAS ROOT; ARTEMISIA CINA PRE-FLOWERING TOP; SILVER; ASAFETIDA; WORMWOOD; ONION; TANACETUM VULGARE TOP 6; 6; 12; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1139_628151e8-80a8-7e69-e053-2a91aa0af3d2 62106-1139 HUMAN OTC DRUG UNDA 40 Capsicum annuum, Pilocarpus, Thymus vulgaris, Urtica urens, Aurum metallicum, Cuprum metallicum LIQUID ORAL 20150526 UNAPPROVED HOMEOPATHIC Seroyal USA PILOCARPUS JABORANDI LEAF; CAPSICUM; THYMUS VULGARIS WHOLE; URTICA URENS; GOLD; COPPER 4; 4; 4; 4; 12; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1140_628151e8-80a8-7e69-e053-2a91aa0af3d2 62106-1140 HUMAN OTC DRUG UNDA 41 Primula veris, Rheum, Juglans regia, Sarsaparilla, Nux vomica, Symphytum officinale, Plumbum metallicum LIQUID ORAL 20150526 UNAPPROVED HOMEOPATHIC Seroyal USA SARSAPARILLA; PRIMULA VERIS; STRYCHNOS NUX-VOMICA SEED; COMFREY ROOT; LEAD; RHEUM TANGUTICUM WHOLE; ENGLISH WALNUT 4; 4; 4; 6; 12; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1141_4458d1ae-a917-6ce1-e054-00144ff88e88 62106-1141 HUMAN OTC DRUG Unda 42 Arnica montana, Aconitum napellus, Gelsemium sempervirens, Aurum metallicum, Cuprum metallicum LIQUID ORAL 20150116 UNAPPROVED HOMEOPATHIC Seroyal USA ACONITUM NAPELLUS; GELSEMIUM SEMPERVIRENS ROOT; GOLD; ARNICA MONTANA; COPPER 4; 4; 12; 4; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1142_5abb584f-9f49-41f0-e053-2991aa0a8c4f 62106-1142 HUMAN OTC DRUG UNDA 43 Aluminium metallicum, Asperula odorata, Equisetum arvense, Jateorhiza palmata, Marrubium vulgare, Ocimum basilicum, Stannum metallicum LIQUID ORAL 20150922 UNAPPROVED HOMEOPATHIC Seroyal USA EQUISETUM ARVENSE TOP; JATEORHIZA CALUMBA ROOT; GALIUM ODORATUM; MARRUBIUM VULGARE; BASIL; TIN; ALUMINUM 4; 4; 4; 4; 4; 12; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1143_62816a61-a64c-22b3-e053-2a91aa0adade 62106-1143 HUMAN OTC DRUG Unda 44 Inula helenium Root, Juniperus communis berry, Uva-ursi Leaf, Dulcamara Stem and Leaf, Cytisus scoparius Aerial Parts, Stigmata maidis Style and Stigma, Argentum metallicum, Aurum metallicum LIQUID ORAL 20141217 UNAPPROVED HOMEOPATHIC Seroyal USA GOLD; SILVER; JUNIPER BERRY; ARCTOSTAPHYLOS UVA-URSI LEAF; SOLANUM DULCAMARA STEM; CYTISUS SCOPARIUS FLOWERING TOP; CORN SILK; INULA HELENIUM ROOT 12; 12; 4; 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1144_6281a71d-04c8-2614-e053-2991aa0a6b4d 62106-1144 HUMAN OTC DRUG Unda 45 Equisetum arvense, Millefolium, Saxifraga granulata, Dulcamara, Uva-ursi, Argentum metallicum, Stannum metallicum LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC Seroyal USA SAXIFRAGA GRANULATA WHOLE; EQUISETUM ARVENSE TOP; ACHILLEA MILLEFOLIUM; SOLANUM DULCAMARA TOP; ARCTOSTAPHYLOS UVA-URSI LEAF; TIN; SILVER 5; 5; 5; 5; 5; 12; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1145_2f10b9be-fdf4-17eb-e054-00144ff8d46c 62106-1145 HUMAN OTC DRUG Unda 46 Absinthium, Jateorhiza palmata Root, Condurango Bark, Mentha piperita, Aloe socotrina, Argentum metallicum LIQUID ORAL 20150209 UNAPPROVED HOMEOPATHIC Seroyal USA ALOE; SILVER; WORMWOOD; JATEORHIZA CALUMBA ROOT; MARSDENIA CONDURANGO BARK; MENTHA PIPERITA 10; 12; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1146_5abb584f-9f49-41f0-e053-2991aa0a8c4f 62106-1146 HUMAN OTC DRUG UNDA 47 Absinthium, Arnica montana, Aurum metallicum, Jateorhiza palmata, Rosmarinus officinalis, Stibium metallicum, Thymus vulgaris, Valeriana officinalis LIQUID ORAL 20150922 UNAPPROVED HOMEOPATHIC Seroyal USA THYMUS VULGARIS WHOLE; VALERIAN; WORMWOOD; ARNICA MONTANA ROOT; GOLD; JATEORHIZA CALUMBA ROOT; ROSEMARY; ANTIMONY 6; 6; 6; 6; 12; 6; 6; 15 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1147_6281a71d-04c8-2614-e053-2991aa0a6b4d 62106-1147 HUMAN OTC DRUG Unda 48 Condurango, Calendula officinalis, Lycopodium clavatum, Sabina, Thuja occidentalis, Aurum metallicum, Plumbum metallicum, Arsenicum album LIQUID ORAL 20150508 UNAPPROVED HOMEOPATHIC Seroyal USA MARSDENIA CONDURANGO BARK; CALENDULA OFFICINALIS FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; JUNIPERUS SABINA LEAF; THUJA OCCIDENTALIS LEAFY TWIG; GOLD; LEAD; ARSENIC TRIOXIDE 4; 4; 4; 4; 4; 12; 12; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1148_5aa8e0ee-a448-37fe-e053-2a91aa0a265f 62106-1148 HUMAN OTC DRUG UNDA 49 Aurum metallicum, Condurango Bark, Hypericum perforatum, Ocimum basilicum, Plumbum metallicum LIQUID ORAL 20150922 UNAPPROVED HOMEOPATHIC Seroyal USA GOLD; MARSDENIA CONDURANGO BARK; BASIL; LEAD; HYPERICUM PERFORATUM 12; 5; 5; 12; 5 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1149_4c628182-432b-50e9-e054-00144ff88e88 62106-1149 HUMAN OTC DRUG UNDA 50 Boldo Leaf, Senna Leaflet, Carduus marianus, Millefolium, Aluminium metallicum, Argentum metallicum LIQUID ORAL 20150601 UNAPPROVED HOMEOPATHIC Seroyal USA PEUMUS BOLDUS LEAF; SENNA LEAF; SILYBUM MARIANUM SEED; ACHILLEA MILLEFOLIUM; ALUMINUM; SILVER 4; 4; 4; 4; 12; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1150_5aa8e0ee-a448-37fe-e053-2a91aa0a265f 62106-1150 HUMAN OTC DRUG UNDA 74 Boldo Leaf, Cynara scolymus, Hamamelis virginiana, Lycopodium clavatum, Sepia Inky Juice LIQUID ORAL 20150922 UNAPPROVED HOMEOPATHIC Seroyal USA LYCOPODIUM CLAVATUM SPORE; CYNARA SCOLYMUS LEAF; HAMAMELIS VIRGINIANA BARK; SEPIA OFFICINALIS JUICE; PEUMUS BOLDUS LEAF 6; 4; 4; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1151_3321ee84-0f36-6967-e054-00144ff8d46c 62106-1151 HUMAN OTC DRUG UNDA 76 aloe, marrubium vulgare, orthosiphon stamineus, sarsaparilla, senna, viola tricolor LIQUID ORAL 20160518 UNAPPROVED HOMEOPATHIC Seroyal USA MARRUBIUM VULGARE; CLERODENDRANTHUS SPICATUS LEAF; SARSAPARILLA; SENNA LEAF; ALOE; VIOLA TRICOLOR 4; 4; 4; 4; 10; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1152_5aa77082-8c23-ab16-e053-2991aa0abcfd 62106-1152 HUMAN OTC DRUG UNDA 12 Argentum metallicum, Aurum metallicum, Dulcamara, Fagopyrum esculentum, Illicium verum, Lappa major, Salvia officinalis, Sarsaparilla, Staphysagria, Viola tricolor LIQUID ORAL 20150921 UNAPPROVED HOMEOPATHIC Seroyal USA GOLD; SOLANUM DULCAMARA TOP; FAGOPYRUM ESCULENTUM; STAR ANISE FRUIT; ARCTIUM LAPPA ROOT; SAGE; SARSAPARILLA; DELPHINIUM STAPHISAGRIA SEED; SILVER; VIOLA TRICOLOR 12; 4; 4; 4; 4; 4; 4; 12; 12; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1153_6387cc58-ae5c-e43f-e053-2991aa0adfe8 62106-1153 HUMAN OTC DRUG Unda 203 Aesculus hippocastanum, Crataegus, Rheum, Stigmata maidis, Strophanthus gratus LIQUID ORAL 20160205 UNAPPROVED HOMEOPATHIC Seroyal USA CHINESE RHUBARB ROOT; STROPHANTHUS GRATUS SEED; CORN SILK; CRATAEGUS FRUIT; HORSE CHESTNUT 5; 5; 5; 5; 5 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1154_5aa942d9-6563-3f3b-e053-2991aa0aa484 62106-1154 HUMAN OTC DRUG UNDA 210 Boldo Leaf, Crataegus, Lactuca virosa, Passiflora incarnata, Valeriana officinalis LIQUID ORAL 20150922 UNAPPROVED HOMEOPATHIC Seroyal USA PEUMUS BOLDUS LEAF; CRATAEGUS FRUIT; LACTUCA VIROSA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1155_5a9707c1-4e86-c4c6-e053-2a91aa0a6ef6 62106-1155 HUMAN OTC DRUG UNDA 212 Menyanthes trifoliata, Viola tricolor, Hydrastis canadensis, Aloe socotrina LIQUID ORAL 20150602 UNAPPROVED HOMEOPATHIC Seroyal USA MENYANTHES TRIFOLIATA; VIOLA TRICOLOR; GOLDENSEAL; ALOE 4; 4; 10; 10 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1156_2f1d6e56-b79f-486e-e054-00144ff88e88 62106-1156 HUMAN OTC DRUG UNDA 219 Crataegus, Lactuca virosa, Passiflora incarnata, Thymus vulgaris, Valeriana officinalis LIQUID ORAL 20160327 UNAPPROVED HOMEOPATHIC Seroyal USA CRATAEGUS FRUIT; THYME; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; LACTUCA VIROSA 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1157_62868fdc-fa3d-5a27-e053-2991aa0a225d 62106-1157 HUMAN OTC DRUG UNDA 220 Grindelia, Pilocarpus, Salvia officinalis, Senega officinalis, Stramonium, Valeriana officinalis LIQUID ORAL 20150922 UNAPPROVED HOMEOPATHIC Seroyal USA GRINDELIA HIRSUTULA FLOWERING TOP; PILOCARPUS MICROPHYLLUS LEAF; SAGE; DATURA STRAMONIUM; VALERIAN; POLYGALA SENEGA ROOT 6; 6; 6; 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1158_5a9707c1-4e86-c4c6-e053-2a91aa0a6ef6 62106-1158 HUMAN OTC DRUG UNDA 226 Urtica dioica, Berberis vulgaris, Boldo, Juniperus communis, Aloe socotrina, Chelidonium majus LIQUID ORAL 20150602 UNAPPROVED HOMEOPATHIC Seroyal USA PEUMUS BOLDUS LEAF; URTICA DIOICA; BERBERIS VULGARIS ROOT BARK; JUNIPER BERRY; ALOE; CHELIDONIUM MAJUS 6; 6; 6; 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1159_5abbb116-48fd-6d73-e053-2a91aa0a8a98 62106-1159 HUMAN OTC DRUG Unda 228 Valeriana officinalis Root, Melissa officinalis Whole Plant, Verbena officinalis Whole Plant, Millefolium Whole Plant, Thymus vulgaris Aerial Parts, Passiflora incarnata Aerial Parts, Lactuca virosa Whole Plant LIQUID ORAL 20141217 UNAPPROVED HOMEOPATHIC Seroyal USA MELISSA OFFICINALIS; ACHILLEA MILLEFOLIUM; LACTUCA VIROSA; THYME; PASSIFLORA INCARNATA FLOWERING TOP; VERBENA OFFICINALIS; VALERIAN 4; 4; 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1160_445a130f-6142-2534-e054-00144ff88e88 62106-1160 HUMAN OTC DRUG Unda 233 Rheum, Crataegus, Uva-ursi, Rhus toxicodendron, Hamamelis virginiana LIQUID ORAL 20150116 UNAPPROVED HOMEOPATHIC Seroyal USA RHEUM TANGUTICUM WHOLE; HAWTHORN LEAF WITH FLOWER; ARCTOSTAPHYLOS UVA-URSI LEAF; TOXICODENDRON PUBESCENS LEAF; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1161_43a3d9da-f7ea-2257-e054-00144ff8d46c 62106-1161 HUMAN OTC DRUG UNDA 240 Equisetum arvense, Gentiana lutea, Salvia officinalis, Saxifraga granulata, Spiraea ulmaria LIQUID ORAL 20161214 UNAPPROVED HOMEOPATHIC Seroyal USA FILIPENDULA ULMARIA ROOT; SAGE; GENTIANA LUTEA ROOT; SAXIFRAGA GRANULATA FLOWERING TOP; EQUISETUM ARVENSE BRANCH 6; 6; 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1162_5aa64b40-ffa9-3f0a-e053-2991aa0a55c8 62106-1162 HUMAN OTC DRUG UNDA 243 Boldo Leaf, Cholesterinum, Combretum micranthum, Lycopodium clavatum, Podophyllum peltatum LIQUID ORAL 20150929 UNAPPROVED HOMEOPATHIC Seroyal USA PEUMUS BOLDUS LEAF; CHOLESTEROL; COMBRETUM MICRANTHUM LEAF; LYCOPODIUM CLAVATUM SPORE; PODOPHYLLUM PELTATUM ROOT 4; 12; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1163_4c5e6f09-5beb-6b0a-e054-00144ff8d46c 62106-1163 HUMAN OTC DRUG Unda 245 Rheum, Viburnum prunifolium, Thuja occidentalis, Pulsatilla, Fagopyrum esculentum LIQUID ORAL 20150119 UNAPPROVED HOMEOPATHIC Seroyal USA RHEUM TANGUTICUM WHOLE; VIBURNUM PRUNIFOLIUM BARK; THUJA OCCIDENTALIS LEAFY TWIG; PULSATILLA VULGARIS; FAGOPYRUM ESCULENTUM 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1164_5383e4f9-337b-74b5-e054-00144ff88e88 62106-1164 HUMAN OTC DRUG UNDA 248 Crataegus, Magnolia grandiflora, Passiflora incarnata, Strophanthus gratus LIQUID ORAL 20170704 UNAPPROVED HOMEOPATHIC Seroyal USA STROPHANTHUS GRATUS SEED; CRATAEGUS FRUIT; MAGNOLIA GRANDIFLORA FLOWER; PASSIFLORA INCARNATA FLOWERING TOP 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1165_5a9707c1-4e86-c4c6-e053-2a91aa0a6ef6 62106-1165 HUMAN OTC DRUG UNDA 258 Berberis vulgaris, Bryonia dioica, Lycopodium clavatum, Mercurialis annua, Hydrastis canadensis, Boldo, Solidago virgaurea LIQUID ORAL 20150602 UNAPPROVED HOMEOPATHIC Seroyal USA LYCOPODIUM CLAVATUM SPORE; MERCURIALIS ANNUA FLOWERING TOP; GOLDENSEAL; PEUMUS BOLDUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT 4; 4; 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1166_5bb0acb9-be38-7096-e053-2a91aa0adf1c 62106-1166 HUMAN OTC DRUG UNDA 270 Calendula officinalis, Dulcamara, Equisetum arvense, Hypericum perforatum LIQUID ORAL 20171017 UNAPPROVED HOMEOPATHIC Seroyal USA SOLANUM DULCAMARA STEM; CALENDULA OFFICINALIS FLOWERING TOP; EQUISETUM ARVENSE BRANCH; HYPERICUM PERFORATUM 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1167_62868fdc-fa3d-5a27-e053-2991aa0a225d 62106-1167 HUMAN OTC DRUG UNDA 273 Arnica montana, Equisetum arvense, Polygonum hydropiperoides, Rubus fruticosus, Verbascum densiflorum LIQUID ORAL 20150922 UNAPPROVED HOMEOPATHIC Seroyal USA ARNICA MONTANA ROOT; EQUISETUM ARVENSE BRANCH; PERSICARIA PUNCTATA; RUBUS FRUTICOSUS LEAF; VERBASCUM DENSIFLORUM FLOWERING TOP 4; 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-1168_5a950ca4-3522-9120-e053-2991aa0aacb2 62106-1168 HUMAN OTC DRUG UNDA 295 Pulsatilla, Nux vomica, Aloe socotrina LIQUID ORAL 20150527 UNAPPROVED HOMEOPATHIC Seroyal USA STRYCHNOS NUX-VOMICA SEED; ALOE; PULSATILLA VULGARIS 4; 6; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1169_244cdf03-ac10-2505-e054-00144ff88e88 62106-1169 HUMAN OTC DRUG UNDA 312 Angelica archangelica, Drosera, Grindelia, Lamium album, Pinus sylvestris, Rubus fruticosus, Senega officinalis LIQUID ORAL 20150923 UNAPPROVED HOMEOPATHIC Seroyal USA DROSERA ROTUNDIFOLIA FLOWERING TOP; GRINDELIA HIRSUTULA FLOWERING TOP; PINUS SYLVESTRIS LEAFY TWIG; ANGELICA ARCHANGELICA ROOT; LAMIUM ALBUM; RUBUS FRUTICOSUS LEAF; POLYGALA SENEGA ROOT 6; 6; 6; 6; 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1170_4d505bd6-281a-6c7f-e054-00144ff88e88 62106-1170 HUMAN OTC DRUG UNDA 600 Berberis vulgaris, Rheum, Rhus toxicodendron LIQUID ORAL 20170505 UNAPPROVED HOMEOPATHIC Seroyal USA RHEUM OFFICINALE ROOT; BERBERIS VULGARIS ROOT BARK; TOXICODENDRON PUBESCENS SHOOT 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1171_244cdf03-ac10-2505-e054-00144ff88e88 62106-1171 HUMAN OTC DRUG UNDA 700 Berberis vulgaris, Calcarea fluorica LIQUID ORAL 20150923 UNAPPROVED HOMEOPATHIC Seroyal USA BERBERIS VULGARIS ROOT BARK; CALCIUM FLUORIDE 4; 12 [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1172_445b9116-e350-5720-e054-00144ff88e88 62106-1172 HUMAN OTC DRUG UNDA 710 Apis mellifica, Calendula officinalis, Lycopodium clavatum, Dulcamara, Aurum metallicum LIQUID ORAL 20150910 UNAPPROVED HOMEOPATHIC Seroyal USA APIS MELLIFERA; LYCOPODIUM CLAVATUM SPORE; SOLANUM DULCAMARA TOP; GOLD; CALENDULA OFFICINALIS FLOWERING TOP 4; 4; 4; 12; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1173_206b66f0-67e2-5626-e054-00144ff88e88 62106-1173 HUMAN OTC DRUG UNDA 1000 Rubus fruticosus, Spongia tosta, Calendula officinalis, Drosera LIQUID ORAL 20150923 UNAPPROVED HOMEOPATHIC Seroyal USA RUBUS FRUTICOSUS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; DROSERA ROTUNDIFOLIA FLOWERING TOP; SPONGIA OFFICINALIS SKELETON, ROASTED 4; 4; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1174_5a950ca4-3522-9120-e053-2991aa0aacb2 62106-1174 HUMAN OTC DRUG UNDA 1001 Thymus vulgaris, Valeriana officinalis, Lactuca virosa, Passiflora incarnata LIQUID ORAL 20150527 UNAPPROVED HOMEOPATHIC Seroyal USA THYMUS VULGARIS WHOLE; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP; LACTUCA VIROSA 6; 6; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1176_5aa942d9-6563-3f3b-e053-2991aa0aa484 62106-1176 HUMAN OTC DRUG UNDA 202 Aurum metallicum, Calcarea fluorica, Cuprum metallicum, Gelsemium sempervirens, Sulphur LIQUID ORAL 20150922 UNAPPROVED HOMEOPATHIC Seroyal USA CALCIUM FLUORIDE; COPPER; GELSEMIUM SEMPERVIRENS WHOLE; SULFUR; GOLD 12; 12; 4; 6; 12 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1177_5abb24f3-3ae9-f904-e053-2991aa0a471e 62106-1177 HUMAN OTC DRUG Calendula Cream Calendula officinalis CREAM TOPICAL 20150120 UNAPPROVED HOMEOPATHIC Seroyal USA CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/40g N 20181231 62106-1179_4c59a756-5461-0c08-e054-00144ff8d46c 62106-1179 HUMAN OTC DRUG Cheliderm Cream Thuja occidentalis, Calendula officinalis CREAM TOPICAL 20170404 UNAPPROVED HOMEOPATHIC Seroyal USA THUJA OCCIDENTALIS LEAFY TWIG; CALENDULA OFFICINALIS FLOWERING TOP 1; 1 [hp_X]/40g; [hp_X]/40g N 20181231 62106-1180_5abb24f3-3ae9-f904-e053-2991aa0a471e 62106-1180 HUMAN OTC DRUG Arnica Cream Arnica montana CREAM TOPICAL 20150120 UNAPPROVED HOMEOPATHIC Seroyal USA ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP 1; 1 [hp_X]/40g; [hp_X]/40g N 20181231 62106-1181_156cb778-c6a7-0681-e054-00144ff8d46c 62106-1181 HUMAN OTC DRUG Drosera Plex Cough Syrup LIQUID ORAL 20150506 UNAPPROVED HOMEOPATHIC Seroyal USA PULSATILLA PRATENSIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; HYOSCYAMUS NIGER; DROSERA ROTUNDIFOLIA FLOWERING TOP; IPECAC; ORIGANUM VULGARE SUBSP. HIRTUM WHOLE; PAPAVER RHOEAS FLOWER; SULFUR; LACHESIS MUTA VENOM 6; 8; 8; 8; 1; 3; 4; 2; 6; 8 [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL N 20181231 62106-1183_638e5921-058d-32ff-e053-2a91aa0a6972 62106-1183 HUMAN OTC DRUG ECHINASYR Echinacea purpurea LIQUID ORAL 20150121 UNAPPROVED HOMEOPATHIC Seroyal USA ECHINACEA PURPUREA 18.125 g/125mL N 20191231 62106-1192_26fc655c-6a29-52a2-e054-00144ff8d46c 62106-1192 HUMAN OTC DRUG ALLIUM CEPA PLEX Allium cepa, Belladonna, Euphrasia officinalis, Hydrastis canadensis, Kali bichromicum, Mercurius dulcis, Sambucus nigra LIQUID ORAL 20151215 UNAPPROVED HOMEOPATHIC Seroyal USA EUPHRASIA STRICTA; ONION; ATROPA BELLADONNA WHOLE; GOLDENSEAL; POTASSIUM DICHROMATE; CALOMEL; SAMBUCUS NIGRA FLOWERING TOP 6; 6; 6; 6; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-1194_43a4b756-c80e-5043-e054-00144ff8d46c 62106-1194 HUMAN OTC DRUG Drosera Plex Arnica montana, Belladonna, Cina, Coccus cacti, Corallium rubrum, Cuprum metallicum, Drosera, Ferrum phosphoricum, Ipecacuanha, Solidago virgaurea LIQUID ORAL 20161214 UNAPPROVED HOMEOPATHIC Seroyal USA COPPER; ARTEMISIA CINA FLOWER; FERRUM PHOSPHORICUM; IPECAC; SOLIDAGO VIRGAUREA FLOWERING TOP; ATROPA BELLADONNA WHOLE; ARNICA MONTANA ROOT; PROTORTONIA CACTI; CORALLIUM RUBRUM EXOSKELETON; DROSERA ROTUNDIFOLIA FLOWERING TOP 6; 6; 6; 6; 2; 6; 6; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-1195_270e4074-030a-2573-e054-00144ff88e88 62106-1195 HUMAN OTC DRUG LOBELIA PLEX Antimonium sulphuratum aureum, Arsenicum iodatum, Blatta orientalis, Eriodictyon californicum, Ipecacuanha, Lobelia inflata, Natrum sulphuricum, Sambucus nigra, Senega officinalis LIQUID ORAL 20151216 UNAPPROVED HOMEOPATHIC Seroyal USA BLATTA ORIENTALIS; ANTIMONY PENTASULFIDE; ARSENIC TRIIODIDE; ERIODICTYON CALIFORNICUM LEAF; IPECAC; LOBELIA INFLATA; SODIUM SULFATE; SAMBUCUS NIGRA FLOWERING TOP; POLYGALA SENEGA ROOT 6; 8; 8; 3; 4; 8; 10; 1; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-1198_228f83c4-269d-49b3-e054-00144ff8d46c 62106-1198 HUMAN OTC DRUG PAEONIA Plex Aesculus hippocastanum,Arnica montana, Graphites, Hamamelis virginiana, Nitricum acidum, Nux vomica, Paeonia officinalis, Sulphur LIQUID ORAL 20151020 UNAPPROVED HOMEOPATHIC Seroyal USA ARNICA MONTANA ROOT; GRAPHITE; HAMAMELIS VIRGINIANA BARK; PAEONIA OFFICINALIS ROOT; SULFUR; STRYCHNOS NUX-VOMICA SEED; NITRIC ACID; HORSE CHESTNUT 4; 4; 4; 4; 6; 4; 4; 3 [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL N 20181231 62106-1200_330fa208-69c3-6c37-e054-00144ff88e88 62106-1200 HUMAN OTC DRUG CARDUUS PLEX belladonna, carduus marianus, chelidonium majus, cholesterinum, cinchona succirubra, colocynthis, leptandra virginica, lycopodium clavatum, podophyllum peltatum, taraxacum officinale LIQUID ORAL 20160518 UNAPPROVED HOMEOPATHIC Seroyal USA MILK THISTLE; CHOLESTEROL; LYCOPODIUM CLAVATUM SPORE; PODOPHYLLUM PELTATUM ROOT; TARAXACUM OFFICINALE; CHELIDONIUM MAJUS; CULVER'S ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CINCHONA PUBESCENS BARK; ATROPA BELLADONNA 2; 4; 4; 4; 2; 2; 1; 6; 3; 4 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-1201_271093eb-1ff2-1c05-e054-00144ff8d46c 62106-1201 HUMAN OTC DRUG Chelidonium Plex Chelidonium majus, Carduus marianus, Solidago virgaurea, Berberis vulgaris, Dolichos pruriens, Iris versicolor, Ptelea trifoliata, Taraxacum officinale LIQUID ORAL 20141217 UNAPPROVED HOMEOPATHIC Seroyal USA PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; BERBERIS VULGARIS ROOT BARK; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; CHELIDONIUM MAJUS; MILK THISTLE; SOLIDAGO VIRGAUREA FLOWERING TOP 10; 10; 10; 10; 10; 10; 3; 3 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-1202_270efa03-908c-4827-e054-00144ff8d46c 62106-1202 HUMAN OTC DRUG KALIUM CARBONICUM PLEX Asafoetida, Carbo vegetabilis, Cinchona succirubra, Kali carbonicum, Lycopodium clavatum, Nux moschata, Nux vomica, Raphanus sativus var niger LIQUID ORAL 20151216 UNAPPROVED HOMEOPATHIC Seroyal USA ASAFETIDA; ACTIVATED CHARCOAL; CINCHONA PUBESCENS BARK; NUTMEG; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; RAPHANUS SATIVUS 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-1205_26fac368-f3db-6d49-e054-00144ff8d46c 62106-1205 HUMAN OTC DRUG ACIDUM PHOSPHORICUM PLEX Anacardium orientale, Argentum nitricum, Arnica montana, Avena sativa, Gelsemium sempervirens, Kali phosphoricum, Phosphoricum acidum, Selenium metallicum LIQUID ORAL 20151215 UNAPPROVED HOMEOPATHIC Seroyal USA SILVER NITRATE; ARNICA MONTANA ROOT; AVENA SATIVA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; SEMECARPUS ANACARDIUM JUICE; GELSEMIUM SEMPERVIRENS ROOT; PHOSPHORIC ACID 6; 6; 3; 6; 6; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-1207_56e10d0b-1860-351a-e054-00144ff8d46c 62106-1207 HUMAN OTC DRUG CHOLESTERINUM PLEX Cholesterinum, Cholesterinum, Hepatinum, Pulminum LIQUID ORAL 20170816 UNAPPROVED HOMEOPATHIC Seroyal USA CHOLESTEROL; ORYCTOLAGUS CUNICULUS LIVER; ORYCTOLAGUS CUNICULUS LUNG 9; 7; 7 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL N 20181231 62106-1209_22b6863c-d6cf-4823-e054-00144ff8d46c 62106-1209 HUMAN OTC DRUG JUNCTURINUM PLEX Cartilaginum, Juncturinum, Ligamentinum, Osseinum, LIQUID ORAL 20151022 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS KNEE JOINT; ORYCTOLAGUS CUNICULUS LIGAMENT; ORYCTOLAGUS CUNICULUS BONE; ORYCTOLAGUS CUNICULUS CARTILAGE 5; 5; 5; 5 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL N 20181231 62106-1229_0d078750-b00b-248c-e054-00144ff88e88 62106-1229 HUMAN OTC DRUG Angiplex Arum triphyllum, Aconitum napellus, Apis mellifica, Belladonna, Phytolacca decandra, Kali bichromicum, Lachesis mutus, Mercurius solubilis TABLET SUBLINGUAL 20150119 UNAPPROVED HOMEOPATHIC Seroyal USA ARISAEMA TRIPHYLLUM ROOT; ACONITUM NAPELLUS; APIS MELLIFERA; ATROPA BELLADONNA; PHYTOLACCA AMERICANA ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS 4; 8; 8; 8; 8; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62106-1233_5abc1410-98b5-b87b-e053-2991aa0adb85 62106-1233 HUMAN OTC DRUG PYROGENIUM PLEX Arsenicum album, Hepar sulphuris calcareum, Hydrastis canadensis, Kali bichromicum, Kali iodatum, Pyrogenium LIQUID ORAL 20151216 UNAPPROVED HOMEOPATHIC Seroyal USA CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; ARSENIC TRIOXIDE; POTASSIUM IODIDE; RANCID BEEF 5; 5; 5; 5; 5; 6 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL N 20181231 62106-1235_38c89c02-0aff-291e-e054-00144ff8d46c 62106-1235 HUMAN OTC DRUG Melange combination Calcarea sulphurica, Calcium phosphoricum, Kali muriaticum, Kalium phosphoricum, Kali sulphuricum, Magnesia phosphorica, Natrum muriaticum, Natrum phosphoricum, Natrium sulfuricum, Calcarea fluorica, Ferrum phosphoricum, Silicea TABLET ORAL 20141212 UNAPPROVED HOMEOPATHIC Seroyal USA CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; CALCIUM SULFATE ANHYDROUS; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM SULFATE; CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE 6; 6; 6; 6; 6; 12; 6; 6; 6; 6; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62106-1238_4c45c2e7-e4b8-0a93-e054-00144ff8d46c 62106-1238 HUMAN OTC DRUG ANTI-WART Bufo rana, Buxus sempervirens, Juglans regia, Nitricum acidum, Oleander, Stannum metallicum, Sulphur, Taxus baccata, Thuja occidentalis, Vanadium metallicum LIQUID ORAL 20170403 UNAPPROVED HOMEOPATHIC Seroyal USA TIN; ENGLISH WALNUT; NERIUM OLEANDER LEAF; BUFO BUFO CUTANEOUS GLAND; NITRIC ACID; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; VANADIUM; BUXUS SEMPERVIRENS LEAFY TWIG; TAXUS BACCATA WHOLE 10; 2; 6; 12; 10; 10; 8; 10; 6; 6 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-1322_5abc1410-98c7-b87b-e053-2991aa0adb85 62106-1322 HUMAN OTC DRUG Passiflora Plex Passiflora incarnata, Ignatia amara, Jalapa, Coffea cruda, Magnesium metalicum, Palladium metallicum, Tellurium metallicum, Phosphoricum acidum LIQUID SUBLINGUAL 20150209 UNAPPROVED HOMEOPATHIC Seroyal USA PASSIFLORA INCARNATA FLOWERING TOP; IPOMOEA PURGA ROOT; ARABICA COFFEE BEAN; MAGNESIUM; PALLADIUM; TELLURIUM; PHOSPHORIC ACID; STRYCHNOS IGNATII SEED 3; 8; 10; 10; 10; 10; 14; 8 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 62106-1400_0eab06d0-6d00-2d3f-e054-00144ff88e88 62106-1400 HUMAN OTC DRUG Allergiplex Apis mellifica, Pulmo anaphylactica, Pollantinum TABLET SUBLINGUAL 20150209 UNAPPROVED HOMEOPATHIC Seroyal USA APIS MELLIFERA; HISTAMINE; BEE POLLEN 15; 15; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 62106-2022_3990be7c-4f99-55d4-e054-00144ff8d46c 62106-2022 HUMAN OTC DRUG CYSTOPHYLIN Berberis vulgaris, Cantharis, Dulcamara, Equisetum hyemale, Eupatorium purpureum LIQUID ORAL 20160808 UNAPPROVED HOMEOPATHIC Seroyal USA BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; SOLANUM DULCAMARA STEM; EQUISETUM HYEMALE TOP; EUPATORIUM PURPUREUM ROOT 4; 4; 4; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 62106-2023_3991ed57-932e-746b-e054-00144ff8d46c 62106-2023 HUMAN OTC DRUG ENTEROLINER Chamomilla, Chininum arsenicosum, Colocynthis, Mercurius corrosivus, Phosphoricum acidum, Veratrum album LIQUID ORAL 20160808 UNAPPROVED HOMEOPATHIC Seroyal USA PHOSPHORIC ACID; VERATRUM ALBUM ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; MATRICARIA RECUTITA; QUININE ARSENATE; MERCURIC CHLORIDE 3; 6; 6; 4; 6; 8 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 62106-2024_343ce022-32a9-2367-e054-00144ff88e88 62106-2024 HUMAN OTC DRUG ANGINACID Apis mellifica, Baryum muriaticum, Belladonna, Calcium iodatum, Hepar sulphuris calcareum, Kalium bichromicum, Lachesis mutus, Mercurius corrosivus, Phytolacca decandra, Teucrium marum verum LIQUID ORAL 20160602 UNAPPROVED HOMEOPATHIC Seroyal USA APIS MELLIFERA; LACHESIS MUTA VENOM; MERCURIC CHLORIDE; POTASSIUM DICHROMATE; TEUCRIUM MARUM; PHYTOLACCA AMERICANA ROOT; ATROPA BELLADONNA; BARIUM CHLORIDE; CALCIUM IODIDE; CALCIUM SULFIDE 4; 12; 8; 5; 6; 4; 4; 6; 4; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 62106-2025_308d60d9-8120-2a87-e054-00144ff88e88 62106-2025 HUMAN OTC DRUG Gastrunda Anacardium orientale, Argentum nitricum, Arsenicum album, Atropinum sulfuricum, Bismuthum subnitricum, Condurango Bark, Hamamelis virginiana, Hydrastis canadensis, Kalium bichromicum LIQUID ORAL 20160415 UNAPPROVED HOMEOPATHIC Seroyal USA CASHEW; SILVER NITRATE; MARSDENIA CONDURANGO BARK; ARSENIC TRIOXIDE; ATROPINE SULFATE; BISMUTH SUBNITRATE; HAMAMELIS VIRGINIANA BARK; GOLDENSEAL; POTASSIUM DICHROMATE 6; 4; 2; 6; 4; 8; 2; 4; 4 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62106-2026_6387cc58-ae4e-e43f-e053-2991aa0adfe8 62106-2026 HUMAN OTC DRUG ALUMILAX Alumina, Bryonia, Causticum hahnemanni, Collinsonia canadensis, Graphites, Rheum officinale, Selenium metallicum LIQUID ORAL 20160808 UNAPPROVED HOMEOPATHIC Seroyal USA BRYONIA ALBA ROOT; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GRAPHITE; RHEUM OFFICINALE ROOT; ALUMINUM OXIDE; SELENIUM 10; 10; 10; 10; 10; 10; 10 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20191231 62106-2612_2f1c9549-3f28-104d-e054-00144ff8d46c 62106-2612 HUMAN OTC DRUG CAN ALBEX 30X Candida albicans LIQUID ORAL 20160327 UNAPPROVED HOMEOPATHIC Seroyal USA CANDIDA ALBICANS 30 [hp_X]/30mL N 20181231 62106-3126_588871b1-1daf-3053-e053-2a91aa0a8124 62106-3126 HUMAN OTC DRUG Drosera Plex Cough Syrup SYRUP ORAL 20170906 UNAPPROVED HOMEOPATHIC Seroyal USA PULSATILLA PRATENSIS; SPONGIA OFFICINALIS SKELETON, ROASTED; HYOSCYAMUS NIGER; LACHESIS MUTA VENOM; PAPAVER RHOEAS FLOWER; DROSERA ROTUNDIFOLIA; OREGANO FLOWERING TOP; SULFUR; IPECAC; RUMEX CRISPUS ROOT 8; 10; 10; 10; 5; 3; 7; 8; 6; 10 [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL; [hp_X]/180mL N 20181231 62106-3152_4c5ddaff-64ee-556e-e054-00144ff8d46c 62106-3152 HUMAN OTC DRUG CICATRISAN Cream Calendula officinalis, Phytolacca decandra, Bryonia dioica, Balsamum peruvianum, Dulcamara CREAM TOPICAL 20150507 UNAPPROVED HOMEOPATHIC Seroyal USA BALSAM PERU; BRYONIA DIOICA ROOT; SOLANUM DULCAMARA TOP; CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT 1; 1; 1; 1; 1 [hp_X]/40g; [hp_X]/40g; [hp_X]/40g; [hp_X]/40g; [hp_X]/40g N 20181231 62106-3159_62820601-e1a2-a6cb-e053-2991aa0adf51 62106-3159 HUMAN OTC DRUG Proctosan Cream Ratanhia, Aesculus hippocastanum, Collinsonia canadensis, Paeonia officinalis, Negundo CREAM TOPICAL 20151217 UNAPPROVED HOMEOPATHIC Seroyal USA KRAMERIA LAPPACEA ROOT; COLLINSONIA CANADENSIS ROOT; PAEONIA OFFICINALIS ROOT; HORSE CHESTNUT; ACER NEGUNDO INNER BARK 1; 1; 1; 1; 1 [hp_X]/40g; [hp_X]/40g; [hp_X]/40g; [hp_X]/40g; [hp_X]/40g N 20191231 62106-3611_1e29ee8d-51bc-6057-e054-00144ff8d46c 62106-3611 HUMAN OTC DRUG X RAY X ray GRANULE ORAL 20150825 UNAPPROVED HOMEOPATHIC Seroyal USA ALCOHOL, X-RAY EXPOSED (1000 RAD) 6 [hp_X]/1 N 20181231 62106-4803_1223185b-c947-5a9a-e054-00144ff88e88 62106-4803 HUMAN OTC DRUG NITRICUM ACIDUM Nitric acid GRANULE ORAL 20150325 UNAPPROVED HOMEOPATHIC Seroyal USA NITRIC ACID 6 [hp_X]/1 N 20181231 62106-4808_1b7f4459-15bc-1051-e054-00144ff8d46c 62106-4808 HUMAN OTC DRUG PHOSPHORICUM ACIDUM Orthophosphoric acid GRANULE ORAL 20150722 UNAPPROVED HOMEOPATHIC Seroyal USA PHOSPHORIC ACID 3 [hp_X]/1 N 20181231 62106-4820_267c4536-0f96-02c1-e054-00144ff8d46c 62106-4820 HUMAN OTC DRUG ALUMEN Aluminum potassium sulfate GRANULE ORAL 20151209 UNAPPROVED HOMEOPATHIC Seroyal USA ALUM, POTASSIUM 3 [hp_X]/1 E 20171231 62106-4821_173c2930-f45c-6ca8-e054-00144ff88e88 62106-4821 HUMAN OTC DRUG ALUMINA Aluminum oxide GRANULE ORAL 20150529 UNAPPROVED HOMEOPATHIC Seroyal USA ALUMINUM OXIDE 3 [hp_X]/1 E 20171231 62106-4838_270a6b1f-fe15-1d7c-e054-00144ff88e88 62106-4838 HUMAN OTC DRUG AMMONIUM MURIATICUM Ammonium chloride GRANULE ORAL 20151209 UNAPPROVED HOMEOPATHIC Seroyal USA AMMONIUM CATION 1 [hp_X]/1 E 20171231 62106-4852_173d8ccd-8a74-1db0-e054-00144ff88e88 62106-4852 HUMAN OTC DRUG ANTIMONIUM CRUDUM Antimony trisulfide GRANULE ORAL 20150529 UNAPPROVED HOMEOPATHIC Seroyal USA ANTIMONY TRISULFIDE 3 [hp_X]/1 N 20181231 62106-4871_1842dd7e-7fea-5a38-e054-00144ff88e88 62106-4871 HUMAN OTC DRUG ARGENTUM METALLICUM Silver GRANULE ORAL 20150611 UNAPPROVED HOMEOPATHIC Seroyal USA SILVER 3 [hp_X]/1 N 20181231 62106-4873_0d91a1b6-c368-4180-e054-00144ff88e88 62106-4873 HUMAN OTC DRUG ARGENTUM NITRICUM Silver nitrate GRANULE ORAL 20150126 UNAPPROVED HOMEOPATHIC Seroyal USA SILVER NITRATE 6 [hp_X]/1 N 20181231 62106-4878_0d93edc4-ae6f-1e16-e054-00144ff8d46c 62106-4878 HUMAN OTC DRUG ARSENICUM ALBUM Arsenic trioxide GRANULE ORAL 20150126 UNAPPROVED HOMEOPATHIC Seroyal USA ARSENIC TRIOXIDE 6 [hp_X]/1 N 20181231 62106-4893_11be6d89-1adb-6052-e054-00144ff8d46c 62106-4893 HUMAN OTC DRUG AURUM METALLICUM Metallic gold GRANULE ORAL 20150320 UNAPPROVED HOMEOPATHIC Seroyal USA GOLD 3 [hp_X]/1 N 20181231 62106-4901_120f5824-adc0-72d0-e054-00144ff8d46c 62106-4901 HUMAN OTC DRUG BARYTA CARBONICA Barium carbonate GRANULE ORAL 20150324 UNAPPROVED HOMEOPATHIC Seroyal USA BARIUM CARBONATE 6 [hp_X]/1 N 20181231 62106-4925_18435e16-63f0-4294-e054-00144ff8d46c 62106-4925 HUMAN OTC DRUG BORAX Sodium borate GRANULE ORAL 20150611 UNAPPROVED HOMEOPATHIC Seroyal USA SODIUM BORATE 1 [hp_X]/1 N 20181231 62106-4927_267e427c-bc8b-2605-e054-00144ff88e88 62106-4927 HUMAN OTC DRUG BROMIUM Bromine GRANULE ORAL 20151209 UNAPPROVED HOMEOPATHIC Seroyal USA BROMINE 6 [hp_X]/1 N 20181231 62106-4938_20fd2d9b-c1de-53fd-e054-00144ff8d46c 62106-4938 HUMAN OTC DRUG CADMIUM SULPHURICUM Cadmium sulfate GRANULE ORAL 20150930 UNAPPROVED HOMEOPATHIC Seroyal USA CADMIUM SULFIDE 6 [hp_X]/1 N 20181231 62106-4944_11909d7a-acf6-1315-e054-00144ff8d46c 62106-4944 HUMAN OTC DRUG CALCAREA CARBONICA Impure calcium carbonate GRANULE ORAL 20150317 UNAPPROVED HOMEOPATHIC Seroyal USA OYSTER SHELL CALCIUM CARBONATE, CRUDE 1 [hp_X]/1 N 20181231 62106-4948_0da59c9b-ca14-0274-e054-00144ff88e88 62106-4948 HUMAN OTC DRUG CALCAREA FLUORICA Calcium fluoride GRANULE ORAL 20150127 UNAPPROVED HOMEOPATHIC Seroyal USA CALCIUM FLUORIDE 3 [hp_X]/1 N 20181231 62106-4957_17257bf5-c56d-452f-e054-00144ff88e88 62106-4957 HUMAN OTC DRUG CALCAREA PHOSPHORICA Calcium hydrogen phosphate GRANULE ORAL 20150527 UNAPPROVED HOMEOPATHIC Seroyal USA CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 1 [hp_X]/1 N 20181231 62106-4961_14f22e12-c347-07b4-e054-00144ff88e88 62106-4961 HUMAN OTC DRUG CALCAREA SULPHURICA Calcium sulfate GRANULE ORAL 20150430 UNAPPROVED HOMEOPATHIC Seroyal USA CALCIUM SULFATE ANHYDROUS 1 [hp_X]/1 N 20181231 62106-4981_132720e0-df8b-4356-e054-00144ff8d46c 62106-4981 HUMAN OTC DRUG CARBO VEGETABILIS Vegetable charcoal GRANULE ORAL 20150407 UNAPPROVED HOMEOPATHIC Seroyal USA ACTIVATED CHARCOAL 1 [hp_X]/1 N 20181231 62106-4986_121e57bc-77fd-6c7f-e054-00144ff8d46c 62106-4986 HUMAN OTC DRUG CAUSTICUM Hahnemanns causticum GRANULE ORAL 20150325 UNAPPROVED HOMEOPATHIC Seroyal USA CAUSTICUM 3 [hp_X]/1 N 20181231 62106-5020_183b36be-f36d-2c0a-e054-00144ff88e88 62106-5020 HUMAN OTC DRUG CUPRUM METALLICUM Copper GRANULE ORAL 20150611 UNAPPROVED HOMEOPATHIC Seroyal USA COPPER 3 [hp_X]/1 N 20181231 62106-5042_183febbe-c15d-36e7-e054-00144ff8d46c 62106-5042 HUMAN OTC DRUG FERRUM METALLICUM Iron GRANULE ORAL 20150611 UNAPPROVED HOMEOPATHIC Seroyal USA IRON 1 [hp_X]/1 N 20181231 62106-5046_1328fdef-bd27-254c-e054-00144ff88e88 62106-5046 HUMAN OTC DRUG FERRUM PHOSPHORICUM Iron (III) phosphate GRANULE ORAL 20150407 UNAPPROVED HOMEOPATHIC Seroyal USA FERRUM PHOSPHORICUM 1 [hp_X]/1 N 20181231 62106-5058_11a91b50-6410-457b-e054-00144ff88e88 62106-5058 HUMAN OTC DRUG GRAPHITES Plumbago GRANULE ORAL 20150319 UNAPPROVED HOMEOPATHIC Seroyal USA GRAPHITE 1 [hp_X]/1 N 20181231 62106-5062_0dbc4094-8ad5-0ce1-e054-00144ff88e88 62106-5062 HUMAN OTC DRUG HEKLA LAVA Hekla lava GRANULE ORAL 20150128 UNAPPROVED HOMEOPATHIC Seroyal USA HEKLA LAVA 1 [hp_X]/1 N 20181231 62106-5064_119267a1-5d44-2fdd-e054-00144ff88e88 62106-5064 HUMAN OTC DRUG HEPAR SULPHURIS CALCAREUM Impure calcium sulfide GRANULE ORAL 20150318 UNAPPROVED HOMEOPATHIC Seroyal USA CALCIUM SULFIDE 1 [hp_X]/1 N 20181231 62106-5070_12227f65-6c55-5a47-e054-00144ff8d46c 62106-5070 HUMAN OTC DRUG IODIUM Iodine GRANULE ORAL 20150325 UNAPPROVED HOMEOPATHIC Seroyal USA IODINE 3 [hp_X]/1 N 20181231 62106-5078_133897ad-1620-09a4-e054-00144ff88e88 62106-5078 HUMAN OTC DRUG KALI BICHROMICUM Potassium bichromate GRANULE ORAL 20150408 UNAPPROVED HOMEOPATHIC Seroyal USA POTASSIUM DICHROMATE 3 [hp_X]/1 N 20181231 62106-5081_1727e46b-49f2-2b53-e054-00144ff8d46c 62106-5081 HUMAN OTC DRUG KALI CARBONICUM Potassium carbonate GRANULE ORAL 20150528 UNAPPROVED HOMEOPATHIC Seroyal USA POTASSIUM CARBONATE 2 [hp_X]/1 N 20181231 62106-5107_1857ae2d-b264-676c-e054-00144ff88e88 62106-5107 HUMAN OTC DRUG KALI PHOSPHORICUM Potassium dihydrogen phosphate GRANULE ORAL 20150612 UNAPPROVED HOMEOPATHIC Seroyal USA POTASSIUM PHOSPHATE, DIBASIC 1 [hp_X]/1 N 20181231 62106-5110_20fe73c5-ec1a-174a-e054-00144ff8d46c 62106-5110 HUMAN OTC DRUG KALI SULPHURICUM Potassium sulfate GRANULE ORAL 20150930 UNAPPROVED HOMEOPATHIC Seroyal USA POTASSIUM SULFATE 1 [hp_X]/1 N 20181231 62106-5134_1193ebb6-26be-646c-e054-00144ff88e88 62106-5134 HUMAN OTC DRUG MAGNESIA CARBONICA Heavy magnesium carbonate GRANULE ORAL 20150318 UNAPPROVED HOMEOPATHIC Seroyal USA MAGNESIUM CARBONATE 1 [hp_X]/1 N 20181231 62106-5145_1194de8e-d51c-4315-e054-00144ff8d46c 62106-5145 HUMAN OTC DRUG MAGNESIA PHOSPHORICA Magnesium hydrogen phosphate GRANULE ORAL 20150318 UNAPPROVED HOMEOPATHIC Seroyal USA MAGNESIUM PHOSPHATE, DIBASIC 1 [hp_X]/1 N 20181231 62106-5163_0dcdaec0-062c-439d-e054-00144ff88e88 62106-5163 HUMAN OTC DRUG MERCURIUS CORROSIVUS Mercury bichloride GRANULE ORAL 20150129 UNAPPROVED HOMEOPATHIC Seroyal USA MERCURIC CHLORIDE 6 [hp_X]/1 N 20181231 62106-5165_267f2fa1-b666-1202-e054-00144ff8d46c 62106-5165 HUMAN OTC DRUG MERCURIUS DULCIS Mild mercury chloride GRANULE ORAL 20151209 UNAPPROVED HOMEOPATHIC Seroyal USA CALOMEL 6 [hp_X]/1 N 20181231 62106-5175_0dce7b9f-a270-700c-e054-00144ff88e88 62106-5175 HUMAN OTC DRUG MERCURIUS SOLUBILIS Hahnemanns soluble mercury GRANULE ORAL 20150129 UNAPPROVED HOMEOPATHIC Seroyal USA MERCURIUS SOLUBILIS 6 [hp_X]/1 N 20181231 62106-5189_1857eb4e-a5a9-6d91-e054-00144ff88e88 62106-5189 HUMAN OTC DRUG NATRUM CARBONICUM Sodium carbonate GRANULE ORAL 20150612 UNAPPROVED HOMEOPATHIC Seroyal USA SODIUM CARBONATE 1 [hp_X]/1 N 20181231 62106-5206_0dce7b9f-a285-700c-e054-00144ff88e88 62106-5206 HUMAN OTC DRUG NATRUM MURIATICUM Sodium chloride GRANULE ORAL 20150129 UNAPPROVED HOMEOPATHIC Seroyal USA SODIUM CHLORIDE 1 [hp_X]/1 N 20181231 62106-5220_0dd055f6-3aa5-32f5-e054-00144ff88e88 62106-5220 HUMAN OTC DRUG NATRUM SULPHURICUM Disodium sulfate GRANULE ORAL 20150129 UNAPPROVED HOMEOPATHIC Seroyal USA SODIUM SULFATE 1 [hp_X]/1 N 20181231 62106-5249_0dd0f09a-6589-6161-e054-00144ff8d46c 62106-5249 HUMAN OTC DRUG PHOSPHORUS Phosphorus GRANULE ORAL 20150129 UNAPPROVED HOMEOPATHIC Seroyal USA PHOSPHORUS 4 [hp_X]/1 N 20181231 62106-5258_26d2f303-27b2-4c43-e054-00144ff88e88 62106-5258 HUMAN OTC DRUG PLATINUM METALLICUM Platinum GRANULE ORAL 20151213 UNAPPROVED HOMEOPATHIC Seroyal USA PLATINUM 3 [hp_X]/1 N 20181231 62106-5268_14f427ff-be9f-2fa0-e054-00144ff88e88 62106-5268 HUMAN OTC DRUG PLUMBUM METALLICUM Lead GRANULE ORAL 20150430 UNAPPROVED HOMEOPATHIC Seroyal USA LEAD 6 [hp_X]/1 N 20181231 62106-5298_1be08ab1-29a2-1241-e054-00144ff88e88 62106-5298 HUMAN OTC DRUG SELENIUM METALLICUM Metallic selenium GRANULE ORAL 20150727 UNAPPROVED HOMEOPATHIC Seroyal USA SELENIUM 6 [hp_X]/1 N 20181231 62106-5301_0de1b20b-398b-1302-e054-00144ff88e88 62106-5301 HUMAN OTC DRUG SILICEA Silica GRANULE ORAL 20150130 UNAPPROVED HOMEOPATHIC Seroyal USA SILICON DIOXIDE 2 [hp_X]/1 N 20181231 62106-5305_14f4f926-0714-12cd-e054-00144ff8d46c 62106-5305 HUMAN OTC DRUG STANNUM METALLICUM Tin GRANULE ORAL 20150430 UNAPPROVED HOMEOPATHIC Seroyal USA TIN 3 [hp_X]/1 N 20181231 62106-5316_44593745-5276-0b33-e054-00144ff88e88 62106-5316 HUMAN OTC DRUG SULPHUR Sublimed sulfur GRANULE ORAL 20150130 UNAPPROVED HOMEOPATHIC Seroyal USA SULFUR 1 [hp_X]/1 N 20181231 62106-5318_1aefe34f-85b7-20f9-e054-00144ff88e88 62106-5318 HUMAN OTC DRUG SULPHUR IODATUM Sulfur iodide GRANULE ORAL 20150715 UNAPPROVED HOMEOPATHIC Seroyal USA SULFUR IODIDE 3 [hp_X]/1 N 20181231 62106-5367_1195acae-306c-2905-e054-00144ff88e88 62106-5367 HUMAN OTC DRUG ZINCUM METALLICUM Zinc GRANULE ORAL 20150318 UNAPPROVED HOMEOPATHIC Seroyal USA ZINC 3 [hp_X]/1 N 20181231 62106-5565_11960f64-9adc-394f-e054-00144ff88e88 62106-5565 HUMAN OTC DRUG ANTIMONIUM TARTARICUM Tartar emetic GRANULE ORAL 20150318 UNAPPROVED HOMEOPATHIC Seroyal USA ANTIMONY POTASSIUM TARTRATE 3 [hp_X]/1 N 20181231 62106-5612_271f36fb-8d24-49a1-e054-00144ff88e88 62106-5612 HUMAN OTC DRUG Can Albex 500X Candida albicans LIQUID ORAL 20151217 UNAPPROVED HOMEOPATHIC Seroyal USA CANDIDA ALBICANS 500 [hp_X]/30mL N 20181231 62106-5706_20fdb16e-22af-68c2-e054-00144ff8d46c 62106-5706 HUMAN OTC DRUG CHININUM SULPHURICUM Quinine sulfate GRANULE ORAL 20150930 UNAPPROVED HOMEOPATHIC Seroyal USA QUININE SULFATE 3 [hp_X]/1 N 20181231 62106-5732_0dba0c1b-29e5-3ac3-e054-00144ff88e88 62106-5732 HUMAN OTC DRUG CHOLESTERINUM Cholesterine GRANULE ORAL 20150128 UNAPPROVED HOMEOPATHIC Seroyal USA CHOLESTEROL 3 [hp_X]/1 N 20181231 62106-5925_0dba0c1b-2a0c-3ac3-e054-00144ff88e88 62106-5925 HUMAN OTC DRUG FOLLICULINUM Folliculin GRANULE ORAL 20150128 UNAPPROVED HOMEOPATHIC Seroyal USA ESTRONE 3 [hp_X]/1 N 20181231 62106-5945_1b7cb5e7-e1f8-093d-e054-00144ff8d46c 62106-5945 HUMAN OTC DRUG GLONOINUM Glyceryl trinitrate GRANULE ORAL 20150722 UNAPPROVED HOMEOPATHIC Seroyal USA NITROGLYCERIN 6 [hp_X]/1 N 20181231 62106-5986_0dbcef6d-52db-4f54-e054-00144ff8d46c 62106-5986 HUMAN OTC DRUG HISTAMINUM HYDROCHLORICUM Histamine hydrochloride GRANULE ORAL 20150128 UNAPPROVED HOMEOPATHIC Seroyal USA HISTAMINE DIHYDROCHLORIDE 4 [hp_X]/1 N 20181231 62106-6482_1af06ecc-446f-3460-e054-00144ff88e88 62106-6482 HUMAN OTC DRUG THIOSINAMINUM Thiosinamine GRANULE ORAL 20150715 UNAPPROVED HOMEOPATHIC Seroyal USA ALLYLTHIOUREA 3 [hp_X]/1 N 20181231 62106-6593_1191adcf-e1d2-3e46-e054-00144ff8d46c 62106-6593 HUMAN OTC DRUG APIS MELLIFICA Honeybee GRANULE ORAL 20150318 UNAPPROVED HOMEOPATHIC Seroyal USA APIS MELLIFERA 1 [hp_X]/1 N 20181231 62106-6607_119267a1-5d1d-2fdd-e054-00144ff88e88 62106-6607 HUMAN OTC DRUG CANTHARIS Cantharides GRANULE ORAL 20150318 UNAPPROVED HOMEOPATHIC Seroyal USA LYTTA VESICATORIA 3 [hp_X]/1 N 20181231 62106-6615_24d7bda7-a1d1-41d7-e054-00144ff88e88 62106-6615 HUMAN OTC DRUG COCCUS CACTI Cochineal GRANULE ORAL 20151118 UNAPPROVED HOMEOPATHIC Seroyal USA PROTORTONIA CACTI 1 [hp_X]/1 N 20181231 62106-6619_24d7b178-2a8f-37c2-e054-00144ff8d46c 62106-6619 HUMAN OTC DRUG CROTALUS HORRIDUS Timber rattlesnake GRANULE ORAL 20151118 UNAPPROVED HOMEOPATHIC Seroyal USA CROTALUS HORRIDUS HORRIDUS VENOM 8 [hp_X]/1 N 20181231 62106-6633_2f1dbbc3-b6c2-3758-e054-00144ff8d46c 62106-6633 HUMAN OTC DRUG FORMICA RUFA Red ant GRANULE ORAL 20160327 UNAPPROVED HOMEOPATHIC Seroyal USA FORMICA RUFA 1 [hp_X]/1 N 20181231 62106-6653_2f1dc16b-9e59-4f1f-e054-00144ff88e88 62106-6653 HUMAN OTC DRUG BOTHROPS LANCEOLATUS Yellow viper GRANULE ORAL 20160327 UNAPPROVED HOMEOPATHIC Seroyal USA BOTHROPS ATROX VENOM 12 [hp_C]/1 N 20181231 62106-6654_0dbb70b5-a7da-6bdd-e054-00144ff88e88 62106-6654 HUMAN OTC DRUG LACHESIS MUTUS Bushmaster GRANULE ORAL 20150128 UNAPPROVED HOMEOPATHIC Seroyal USA LACHESIS MUTA VENOM 8 [hp_X]/1 N 20181231 62106-6698_24d86c23-666d-00dc-e054-00144ff8d46c 62106-6698 HUMAN OTC DRUG SPONGIA TOSTA Roasted sponge GRANULE ORAL 20151118 UNAPPROVED HOMEOPATHIC Seroyal USA SPONGIA OFFICINALIS SKELETON, ROASTED 1 [hp_X]/1 N 20181231 62106-6701_24e44b83-bc1f-1eed-e054-00144ff8d46c 62106-6701 HUMAN OTC DRUG TARENTULA HISPANA Tarantula GRANULE ORAL 20151119 UNAPPROVED HOMEOPATHIC Seroyal USA LYCOSA TARANTULA 8 [hp_X]/1 N 20181231 62106-6718_1191adcf-e1f5-3e46-e054-00144ff8d46c 62106-6718 HUMAN OTC DRUG SEPIA Sepia GRANULE ORAL 20150318 UNAPPROVED HOMEOPATHIC Seroyal USA SEPIA OFFICINALIS JUICE 1 [hp_X]/1 N 20181231 62106-6754_1ad8a74c-feab-46f1-e054-00144ff88e88 62106-6754 HUMAN OTC DRUG CANDIDA ALBICANS Candida albicans GRANULE ORAL 20150714 UNAPPROVED HOMEOPATHIC Seroyal USA CANDIDA ALBICANS 6 [hp_X]/1 N 20181231 62106-6861_1728a084-4bbb-4786-e054-00144ff8d46c 62106-6861 HUMAN OTC DRUG LUESINUM Syphilinum GRANULE ORAL 20150528 UNAPPROVED HOMEOPATHIC Seroyal USA TREPONEMIC SKIN CANKER HUMAN 2 [hp_X]/1 N 20181231 62106-6870_0a46b08f-86c5-6cc7-e054-00144ff88e88 62106-6870 HUMAN OTC DRUG Muco coccinum KLEBSIELLA PNEUMONIAE TABLET SUBLINGUAL 20141015 UNAPPROVED HOMEOPATHIC Seroyal USA ANAEROCOCCUS TETRADIUS; INFLUENZA A VIRUS; INFLUENZA B VIRUS; KLEBSIELLA PNEUMONIAE; MORAXELLA CATARRHALIS SUBSP. CATARRHALIS 200; 200; 200; 200; 200 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 62106-6946_17382517-0aeb-1514-e054-00144ff8d46c 62106-6946 HUMAN OTC DRUG TUBERCULINUM KOCH TK GRANULE ORAL 20150529 UNAPPROVED HOMEOPATHIC Seroyal USA TUBERCULIN PURIFIED PROTEIN DERIVATIVE 24 [hp_X]/1 N 20181231 62106-6973_1b7b4b1d-2632-1fbe-e054-00144ff88e88 62106-6973 HUMAN OTC DRUG BULBINUM Medulla oblongata GRANULE ORAL 20150722 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS SPINAL CORD 3 [hp_X]/1 N 20181231 62106-6975_1b7ba317-d1e1-475b-e054-00144ff8d46c 62106-6975 HUMAN OTC DRUG CARDINUM Heart GRANULE ORAL 20150722 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS WHOLE 3 [hp_X]/1 N 20181231 62106-6977_11a60f9d-e539-424c-e054-00144ff8d46c 62106-6977 HUMAN OTC DRUG CEREBELLINUM Cerebellum GRANULE ORAL 20150319 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS HYPOTHALAMUS 6 [hp_X]/1 N 20181231 62106-6978_18557d61-7412-6efb-e054-00144ff8d46c 62106-6978 HUMAN OTC DRUG CEREBRINUM Cerebrum GRANULE ORAL 20150612 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS HYPOTHALAMUS 6 [hp_X]/1 N 20181231 62106-6982_12204912-9b77-0c7e-e054-00144ff88e88 62106-6982 HUMAN OTC DRUG CORPUS CALLOSUM Corpus callosum GRANULE ORAL 20150325 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS WHOLE 6 [hp_X]/1 N 20181231 62106-6984_11bb8608-b599-63e9-e054-00144ff8d46c 62106-6984 HUMAN OTC DRUG CORTICO SURRENINUM Adrenal cortex GRANULE ORAL 20150320 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS WHOLE 3 [hp_X]/1 N 20181231 62106-6988_11a88159-a00e-1983-e054-00144ff8d46c 62106-6988 HUMAN OTC DRUG DIENCEPHALINUM Diencephalon GRANULE ORAL 20150319 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS HYPOTHALAMUS 6 [hp_X]/1 N 20181231 62106-6989_25da4462-5f70-3f8d-e054-00144ff88e88 62106-6989 HUMAN OTC DRUG DUODENINUM Duodenum GRANULE ORAL 20151201 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS DUODENUM 4 [hp_C]/1 N 20181231 62106-6991_1d23dca0-beaf-459a-e054-00144ff88e88 62106-6991 HUMAN OTC DRUG EPIPHYSINUM Pineal gland GRANULE ORAL 20150812 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS BONE 6 [hp_X]/1 N 20181231 62106-7012_11a9cdaf-ba9d-63de-e054-00144ff8d46c 62106-7012 HUMAN OTC DRUG HEPATINUM Liver GRANULE ORAL 20150319 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS LIVER 6 [hp_X]/1 N 20181231 62106-7013_11935887-fd04-5157-e054-00144ff88e88 62106-7013 HUMAN OTC DRUG HYPOPHYSINUM Pituitary gland GRANULE ORAL 20150318 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS LUNG 1 [hp_X]/1 N 20181231 62106-7016_1b7d6688-1014-5da4-e054-00144ff88e88 62106-7016 HUMAN OTC DRUG HYPOTHALAMUS Hypothalamus GRANULE ORAL 20150722 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS HYPOTHALAMUS 3 [hp_X]/1 N 20181231 62106-7075_20fecb11-d3a1-6f1d-e054-00144ff88e88 62106-7075 HUMAN OTC DRUG LIGAMENTINUM Ligament GRANULE ORAL 20150930 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS LIGAMENT 6 [hp_X]/1 N 20181231 62106-7078_11b89d5f-c60e-37b8-e054-00144ff88e88 62106-7078 HUMAN OTC DRUG LUTEINUM Corpus luteum GRANULE ORAL 20150320 UNAPPROVED HOMEOPATHIC Seroyal USA SUS SCROFA CORPUS LUTEUM 3 [hp_X]/1 N 20181231 62106-7086_1b7e7fd3-9352-1424-e054-00144ff88e88 62106-7086 HUMAN OTC DRUG MEDULLOSSEINUM Bone marrow GRANULE ORAL 20150722 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS BONE 6 [hp_X]/1 N 20181231 62106-7094_1222bc2f-6e6b-6cbc-e054-00144ff8d46c 62106-7094 HUMAN OTC DRUG NERVINUM Nerve GRANULE ORAL 20150325 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS SPINAL CORD 6 [hp_X]/1 N 20181231 62106-7107_1d99587e-c185-5588-e054-00144ff8d46c 62106-7107 HUMAN OTC DRUG ORCHITINUM Testis GRANULE ORAL 20150818 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS TESTICLE 3 [hp_X]/1 N 20181231 62106-7109_11f7d33d-ccaf-16c5-e054-00144ff88e88 62106-7109 HUMAN OTC DRUG OOPHORINUM Ovary GRANULE ORAL 20150323 UNAPPROVED HOMEOPATHIC Seroyal USA SUS SCROFA OVARY 6 [hp_X]/1 N 20181231 62106-7110_1569a6cd-d53b-6a80-e054-00144ff88e88 62106-7110 HUMAN OTC DRUG PANCREATINUM Pancreatin GRANULE ORAL 20150505 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS WHOLE 3 [hp_X]/1 N 20181231 62106-7112_11fa1e05-9406-521a-e054-00144ff88e88 62106-7112 HUMAN OTC DRUG PARATHYROIDINUM Parathyroid gland GRANULE ORAL 20150323 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS THYROID 6 [hp_X]/1 N 20181231 62106-7117_155a66b9-cffc-52c8-e054-00144ff88e88 62106-7117 HUMAN OTC DRUG PILINUM Hair bulb GRANULE ORAL 20150505 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS HAIR 6 [hp_X]/1 N 20181231 62106-7122_1e2a798f-a43e-4813-e054-00144ff88e88 62106-7122 HUMAN OTC DRUG PULMINUM Lung GRANULE ORAL 20150825 UNAPPROVED HOMEOPATHIC Seroyal USA ORYCTOLAGUS CUNICULUS LUNG 6 [hp_X]/1 N 20181231 62106-7124_20fdfc2a-3219-69f7-e054-00144ff8d46c 62106-7124 HUMAN OTC DRUG RENINUM Kidney GRANULE ORAL 20150930 UNAPPROVED HOMEOPATHIC Seroyal USA 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HOMEOPATHIC Seroyal USA THYROID, UNSPECIFIED 6 [hp_X]/1 N 20181231 62106-7197_0d91a1b6-c360-4180-e054-00144ff88e88 62106-7197 HUMAN OTC DRUG ACONITUM NAPELLUS Aconite GRANULE ORAL 20150121 UNAPPROVED HOMEOPATHIC Seroyal USA ACONITUM NAPELLUS 3 [hp_X]/1 N 20181231 62106-7200_1716622b-18ae-5807-e054-00144ff8d46c 62106-7200 HUMAN OTC DRUG ACTAEA RACEMOSA CIMICIFUGA RACEMOSA GRANULE ORAL 20150527 UNAPPROVED HOMEOPATHIC Seroyal USA BLACK COHOSH 1 [hp_X]/1 N 20181231 62106-7220_1e288fff-9534-72ae-e054-00144ff88e88 62106-7220 HUMAN OTC DRUG AETHUSA CYNAPIUM Fools parsley GRANULE ORAL 20150825 UNAPPROVED HOMEOPATHIC Seroyal USA AETHUSA CYNAPIUM 3 [hp_X]/1 N 20181231 62106-7228_1716aa51-143a-6f71-e054-00144ff8d46c 62106-7228 HUMAN OTC DRUG AGARICUS MUSCARIUS Bug agaric GRANULE ORAL 20150527 UNAPPROVED HOMEOPATHIC Seroyal USA AMANITA MUSCARIA FRUITING BODY 2 [hp_X]/1 N 20181231 62106-7245_2f1dccf2-ee18-537b-e054-00144ff88e88 62106-7245 HUMAN OTC DRUG AILANTHUS GLANDULOSA Chinese sumach GRANULE ORAL 20160327 UNAPPROVED HOMEOPATHIC Seroyal USA AILANTHUS ALTISSIMA FLOWERING TWIG 1 [hp_X]/1 N 20181231 62106-7264_13280fa9-7af9-7296-e054-00144ff8d46c 62106-7264 HUMAN OTC DRUG ALLIUM CEPA Onion GRANULE ORAL 20150407 UNAPPROVED HOMEOPATHIC Seroyal USA ONION 1 [hp_X]/1 N 20181231 62106-7275_267bee2d-2a52-0126-e054-00144ff8d46c 62106-7275 HUMAN OTC DRUG ALOE Aloe GRANULE ORAL 20151209 UNAPPROVED HOMEOPATHIC Seroyal USA ALOE 1 [hp_X]/1 N 20181231 62106-7304_1840d902-b858-5a98-e054-00144ff8d46c 62106-7304 HUMAN OTC DRUG ANACARDIUM ORIENTALE Marking nut GRANULE ORAL 20150611 UNAPPROVED HOMEOPATHIC Seroyal USA SEMECARPUS ANACARDIUM JUICE 3 [hp_X]/1 E 20171231 62106-7385_0d92b452-088a-636a-e054-00144ff8d46c 62106-7385 HUMAN OTC DRUG ARNICA MONTANA, RADIX Mountain arnica GRANULE ORAL 20150126 UNAPPROVED HOMEOPATHIC Seroyal USA ARNICA MONTANA 3 [hp_X]/1 N 20181231 62106-7474_0d946631-f0d1-0a3f-e054-00144ff88e88 62106-7474 HUMAN OTC DRUG BELLADONNA Deadly nightshade GRANULE ORAL 20150126 UNAPPROVED HOMEOPATHIC Seroyal USA ATROPA BELLADONNA 3 [hp_X]/1 N 20181231 62106-7479_120f5824-adc2-72d0-e054-00144ff8d46c 62106-7479 HUMAN OTC DRUG BELLIS PERENNIS Daisy GRANULE ORAL 20150324 UNAPPROVED HOMEOPATHIC Seroyal USA BELLIS PERENNIS 1 [hp_X]/1 N 20181231 62106-7482_14f22e12-c345-07b4-e054-00144ff88e88 62106-7482 HUMAN OTC DRUG BERBERIS VULGARIS Barberry GRANULE ORAL 20150430 UNAPPROVED HOMEOPATHIC Seroyal USA BERBERIS VULGARIS ROOT BARK 3 [hp_X]/1 N 20181231 62106-7530_11a55a01-8b81-21e5-e054-00144ff8d46c 62106-7530 HUMAN OTC DRUG BRYONIA ALBA White bryony GRANULE ORAL 20150319 UNAPPROVED HOMEOPATHIC Seroyal USA BRYONIA ALBA ROOT 3 [hp_X]/1 N 20181231 62106-7543_18435e16-6409-4294-e054-00144ff8d46c 62106-7543 HUMAN OTC DRUG CACTUS GRANDIFLORUS Night-blooming Cereus GRANULE ORAL 20150611 UNAPPROVED HOMEOPATHIC Seroyal USA SELENICEREUS GRANDIFLORUS STEM 3 [hp_X]/1 N 20181231 62106-7556_1843c021-6580-5a0c-e054-00144ff8d46c 62106-7556 HUMAN OTC DRUG CALENDULA OFFICINALIS Garden marigold GRANULE ORAL 20150611 UNAPPROVED HOMEOPATHIC Seroyal USA CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/1 N 20181231 62106-7576_267e96fc-1d4f-2d8c-e054-00144ff88e88 62106-7576 HUMAN OTC DRUG CAPSICUM ANNUUM Cayenne pepper GRANULE ORAL 20151209 UNAPPROVED HOMEOPATHIC Seroyal USA CAPSICUM 3 [hp_X]/1 N 20181231 62106-7587_18444bf1-2cca-27f0-e054-00144ff88e88 62106-7587 HUMAN OTC DRUG CARDUUS MARIANUS Milk thistle GRANULE ORAL 20150611 UNAPPROVED HOMEOPATHIC Seroyal USA MILK THISTLE 1 [hp_X]/1 N 20181231 62106-7613_20fcfc0c-a11e-395c-e054-00144ff88e88 62106-7613 HUMAN OTC DRUG CAULOPHYLLUM THALICTROIDES Blue cohosh GRANULE ORAL 20150930 UNAPPROVED HOMEOPATHIC Seroyal USA CAULOPHYLLUM THALICTROIDES ROOT 3 [hp_X]/1 N 20181231 62106-7650_0da60ce4-ee30-0e3b-e054-00144ff88e88 62106-7650 HUMAN OTC DRUG CHAMOMILLA German chamomile GRANULE ORAL 20150128 UNAPPROVED HOMEOPATHIC Seroyal USA MATRICARIA RECUTITA 1 [hp_X]/1 N 20181231 62106-7652_121f0b3c-7b4e-2205-e054-00144ff8d46c 62106-7652 HUMAN OTC DRUG CHELIDONIUM MAJUS RADIX Calandine GRANULE ORAL 20150325 UNAPPROVED HOMEOPATHIC Seroyal USA CHELIDONIUM MAJUS ROOT 1 [hp_X]/1 N 20181231 62106-7668_18556cf3-eda3-7144-e054-00144ff8d46c 62106-7668 HUMAN OTC DRUG CINCHONA OFFICINALIS Cinchona GRANULE ORAL 20150612 UNAPPROVED HOMEOPATHIC Seroyal USA CINCHONA OFFICINALIS BARK 2 [hp_X]/1 N 20181231 62106-7689_18417d6d-203a-1731-e054-00144ff8d46c 62106-7689 HUMAN OTC DRUG CINA Santonica GRANULE ORAL 20150611 UNAPPROVED HOMEOPATHIC Seroyal USA ARTEMISIA CINA PRE-FLOWERING TOP 1 [hp_X]/1 N 20181231 62106-7728_121f7873-f71b-3988-e054-00144ff8d46c 62106-7728 HUMAN OTC DRUG COCCULUS INDICUS Fish berry GRANULE ORAL 20150325 UNAPPROVED HOMEOPATHIC Seroyal USA ANAMIRTA COCCULUS SEED 3 [hp_X]/1 N 20181231 62106-7736_121fbc50-9c21-7145-e054-00144ff88e88 62106-7736 HUMAN OTC DRUG COFFEA CRUDA Coffee GRANULE ORAL 20150325 UNAPPROVED HOMEOPATHIC Seroyal USA ARABICA COFFEE BEAN 1 [hp_X]/1 N 20181231 62106-7741_1726ca1b-adb4-0427-e054-00144ff88e88 62106-7741 HUMAN OTC DRUG COLCHICUM AUTUMNALE Meadow saffron GRANULE ORAL 20150528 UNAPPROVED HOMEOPATHIC Seroyal USA COLCHICUM AUTUMNALE BULB 3 [hp_X]/1 N 20181231 62106-7747_13280fa9-7b0d-7296-e054-00144ff8d46c 62106-7747 HUMAN OTC DRUG COLOCYNTHIS Colocynth GRANULE ORAL 20150407 UNAPPROVED HOMEOPATHIC Seroyal USA CITRULLUS COLOCYNTHIS FRUIT PULP 3 [hp_X]/1 N 20181231 62106-7755_1e28e140-8e4d-44fb-e054-00144ff8d46c 62106-7755 HUMAN OTC DRUG CONDURANGO Condor vine GRANULE ORAL 20150825 UNAPPROVED HOMEOPATHIC Seroyal USA MARSDENIA CONDURANGO BARK 1 [hp_X]/1 N 20181231 62106-7756_14f25ae1-6934-0537-e054-00144ff8d46c 62106-7756 HUMAN OTC DRUG CONIUM MACULATUM Poison hemlock GRANULE ORAL 20150430 UNAPPROVED HOMEOPATHIC Seroyal USA CONIUM MACULATUM FLOWERING TOP 3 [hp_X]/1 N 20181231 62106-7797_172742ae-f30a-1737-e054-00144ff88e88 62106-7797 HUMAN OTC DRUG CRATAEGUS OXYACANTHA Hawthorn GRANULE ORAL 20150528 UNAPPROVED HOMEOPATHIC Seroyal USA CRATAEGUS LAEVIGATA FRUIT 4 [hp_X]/1 N 20181231 62106-7804_1855c699-d0d8-16be-e054-00144ff88e88 62106-7804 HUMAN OTC DRUG CROTON TIGLIUM Croton seed GRANULE ORAL 20150612 UNAPPROVED HOMEOPATHIC Seroyal USA CROTON TIGLIUM SEED 3 [hp_X]/1 N 20181231 62106-7878_1221b375-ca62-3c1d-e054-00144ff8d46c 62106-7878 HUMAN OTC DRUG DIGITALIS PURPUREA Foxglove GRANULE ORAL 20150325 UNAPPROVED HOMEOPATHIC Seroyal USA DIGITALIS 6 [hp_X]/1 N 20181231 62106-7892_18569db7-9f7b-2d39-e054-00144ff8d46c 62106-7892 HUMAN OTC DRUG DOLICHOS PRURIENS Cowhage GRANULE ORAL 20150612 UNAPPROVED HOMEOPATHIC Seroyal USA MUCUNA PRURIENS FRUIT TRICHOME 1 [hp_X]/1 N 20181231 62106-7919_1222383b-5f0a-52f9-e054-00144ff8d46c 62106-7919 HUMAN OTC DRUG DROSERA Sundew GRANULE ORAL 20150325 UNAPPROVED HOMEOPATHIC Seroyal USA DROSERA ROTUNDIFOLIA FLOWERING TOP 1 [hp_X]/1 N 20181231 62106-7926_18569db7-9f8c-2d39-e054-00144ff8d46c 62106-7926 HUMAN OTC DRUG DULCAMARA Bittersweet GRANULE ORAL 20150612 UNAPPROVED HOMEOPATHIC Seroyal USA SOLANUM DULCAMARA STEM 2 [hp_X]/1 N 20181231 62106-8000_2f1dbbc3-b6bf-3758-e054-00144ff8d46c 62106-8000 HUMAN OTC DRUG EUPATORIUM PERFOLIATUM Boneset GRANULE ORAL 20160327 UNAPPROVED HOMEOPATHIC Seroyal USA EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X]/1 N 20181231 62106-8020_1856c807-650d-290d-e054-00144ff8d46c 62106-8020 HUMAN OTC DRUG EUPHRASIA OFFICINALIS Euphrasy GRANULE ORAL 20150612 UNAPPROVED HOMEOPATHIC Seroyal USA EUPHRASIA STRICTA 1 [hp_X]/1 N 20181231 62106-8075_0dbb9f5a-98ff-1eb2-e054-00144ff8d46c 62106-8075 HUMAN OTC DRUG Gelsemium Sempervirens Yellow jessamine GRANULE ORAL 20150128 UNAPPROVED HOMEOPATHIC Seroyal USA GELSEMIUM SEMPERVIRENS ROOT 3 [hp_X]/1 N 20181231 62106-8134_0dbc2ad1-4970-0fea-e054-00144ff88e88 62106-8134 HUMAN OTC DRUG HAMAMELIS VIRGINIANA Witch hazel GRANULE ORAL 20150128 UNAPPROVED HOMEOPATHIC Seroyal USA HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X]/1 N 20181231 62106-8152_14f35a83-cf9e-3e5e-e054-00144ff8d46c 62106-8152 HUMAN OTC DRUG HELONIAS DIOICA Blazing star GRANULE ORAL 20150430 UNAPPROVED HOMEOPATHIC Seroyal USA CHAMAELIRIUM LUTEUM ROOT 1 [hp_X]/1 N 20181231 62106-8181_13380b47-b9b5-3f0e-e054-00144ff8d46c 62106-8181 HUMAN OTC DRUG HYDRASTIS CANADENSIS Golden seal GRANULE ORAL 20150408 UNAPPROVED HOMEOPATHIC Seroyal USA GOLDENSEAL 1 [hp_X]/1 N 20181231 62106-8190_1b7cb5e7-e20b-093d-e054-00144ff8d46c 62106-8190 HUMAN OTC DRUG HYOSCYAMUS NIGER Henbane GRANULE ORAL 20150722 UNAPPROVED HOMEOPATHIC Seroyal USA HYOSCYAMUS NIGER 3 [hp_X]/1 N 20181231 62106-8192_0dbe2b9c-07cf-59d0-e054-00144ff88e88 62106-8192 HUMAN OTC DRUG HYPERICUM PERFORATUM St.Johns wort GRANULE ORAL 20150128 UNAPPROVED HOMEOPATHIC Seroyal USA HYPERICUM PERFORATUM 3 [hp_X]/1 N 20181231 62106-8200_0dcccd0d-2ba9-3579-e054-00144ff88e88 62106-8200 HUMAN OTC DRUG IGNATIA AMARA Ignatius bean GRANULE ORAL 20150129 UNAPPROVED HOMEOPATHIC Seroyal USA STRYCHNOS IGNATII SEED 3 [hp_X]/1 N 20181231 62106-8213_0dcd2dce-e6a8-4fd3-e054-00144ff8d46c 62106-8213 HUMAN OTC DRUG IPECACUANHA Ipecac GRANULE ORAL 20150129 UNAPPROVED HOMEOPATHIC Seroyal USA IPECAC 3 [hp_X]/1 N 20181231 62106-8224_1857a4a5-bd3f-649e-e054-00144ff88e88 62106-8224 HUMAN OTC DRUG IRIS VERSICOLOR Blue flag GRANULE ORAL 20150612 UNAPPROVED HOMEOPATHIC Seroyal USA IRIS VERSICOLOR ROOT 1 [hp_X]/1 N 20181231 62106-8250_1b7d6688-1027-5da4-e054-00144ff88e88 62106-8250 HUMAN OTC DRUG KALMIA LATIFOLIA Mountain laurel GRANULE ORAL 20150722 UNAPPROVED HOMEOPATHIC Seroyal USA KALMIA LATIFOLIA LEAF 3 [hp_X]/1 N 20181231 62106-8294_13391da6-0733-1749-e054-00144ff88e88 62106-8294 HUMAN OTC DRUG LEDUM PALUSTRE Wild rosemary GRANULE ORAL 20150408 UNAPPROVED HOMEOPATHIC Seroyal USA LEDUM PALUSTRE WHOLE 4 [hp_X]/1 N 20181231 62106-8324_1857ff63-0344-66e6-e054-00144ff8d46c 62106-8324 HUMAN OTC DRUG LILIUM TIGRINUM Tiger lily GRANULE ORAL 20150612 UNAPPROVED HOMEOPATHIC Seroyal USA LILIUM LANCIFOLIUM WHOLE FLOWERING 1 [hp_X]/1 N 20181231 62106-8345_1b7d6688-103d-5da4-e054-00144ff88e88 62106-8345 HUMAN OTC DRUG LOBELIA INFLATA Indian tobacco GRANULE ORAL 20150722 UNAPPROVED HOMEOPATHIC Seroyal USA LOBELIA INFLATA 3 [hp_X]/1 N 20181231 62106-8367_11b9eb7f-d8f6-62ce-e054-00144ff88e88 62106-8367 HUMAN OTC DRUG LYCOPODIUM CLAVATUM Clubmoss GRANULE ORAL 20150320 UNAPPROVED HOMEOPATHIC Seroyal USA LYCOPODIUM CLAVATUM SPORE 1 [hp_X]/1 N 20181231 62106-8435_267f96e2-fb23-2a3c-e054-00144ff8d46c 62106-8435 HUMAN OTC DRUG MEZEREUM Mezereum GRANULE ORAL 20151209 UNAPPROVED HOMEOPATHIC Seroyal USA DAPHNE MEZEREUM BARK 1 [hp_X]/1 N 20181231 62106-8495_0dd0f09a-6570-6161-e054-00144ff8d46c 62106-8495 HUMAN OTC DRUG NUX VOMICA Poison nut GRANULE ORAL 20150129 UNAPPROVED HOMEOPATHIC Seroyal USA STRYCHNOS NUX-VOMICA SEED 3 [hp_X]/1 N 20181231 62106-8562_1729c69c-0d4c-7476-e054-00144ff8d46c 62106-8562 HUMAN OTC DRUG PASSIFLORA INCARNATA Passion flower GRANULE ORAL 20150528 UNAPPROVED HOMEOPATHIC Seroyal USA PASSIFLORA INCARNATA FLOWERING TOP 1 [hp_X]/1 N 20181231 62106-8598_11ba9350-a613-027f-e054-00144ff88e88 62106-8598 HUMAN OTC DRUG PHYTOLACCA DECANDRA Poke GRANULE ORAL 20150320 UNAPPROVED HOMEOPATHIC Seroyal USA PHYTOLACCA AMERICANA ROOT 2 [hp_X]/1 N 20181231 62106-8648_172a2105-1c37-0ac6-e054-00144ff88e88 62106-8648 HUMAN OTC DRUG PODOPHYLLUM PELTATUM Mayapple GRANULE ORAL 20150528 UNAPPROVED HOMEOPATHIC Seroyal USA PODOPHYLLUM PELTATUM ROOT 5 [hp_X]/1 N 20181231 62106-8716_0dd1a5d1-64f3-6983-e054-00144ff88e88 62106-8716 HUMAN OTC DRUG PULSATILLA Wind flower GRANULE ORAL 20150129 UNAPPROVED HOMEOPATHIC Seroyal USA PULSATILLA VULGARIS 1 [hp_X]/1 N 20181231 62106-8760_18585dcb-3254-0be0-e054-00144ff88e88 62106-8760 HUMAN OTC DRUG RHODODENDRON CHRYSANTHUM Golden flowered rhododendron GRANULE ORAL 20150612 UNAPPROVED HOMEOPATHIC Seroyal USA RHODODENDRON AUREUM LEAF 3 [hp_X]/1 N 20181231 62106-8767_0d57f7ab-7a15-08b3-e054-00144ff88e88 62106-8767 HUMAN OTC DRUG RHUS TOXICODENDRON Poison ivy GRANULE ORAL 20150123 UNAPPROVED HOMEOPATHIC Seroyal USA TOXICODENDRON PUBESCENS LEAF 3 [hp_X]/1 E 20171231 62106-8775_26df47c0-52a1-3226-e054-00144ff88e88 62106-8775 HUMAN OTC DRUG ROBINIA PSEUDOACACIA Black locust GRANULE ORAL 20151213 UNAPPROVED HOMEOPATHIC Seroyal USA ROBINIA PSEUDOACACIA BARK 1 [hp_X]/1 N 20181231 62106-8802_14f4b9f2-116a-07b3-e054-00144ff8d46c 62106-8802 HUMAN OTC DRUG RUMEX CRISPUS Yellow dock GRANULE ORAL 20150430 UNAPPROVED HOMEOPATHIC Seroyal USA RUMEX CRISPUS ROOT 1 [hp_X]/1 N 20181231 62106-8810_0de00ba4-c756-1d6a-e054-00144ff8d46c 62106-8810 HUMAN OTC DRUG RUTA GRAVEOLENS Rue GRANULE ORAL 20150130 UNAPPROVED HOMEOPATHIC Seroyal USA RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/1 N 20181231 62106-8811_173dd09a-fc8e-66b5-e054-00144ff8d46c 62106-8811 HUMAN OTC DRUG SABADILLA Cevadilla GRANULE ORAL 20150529 UNAPPROVED HOMEOPATHIC Seroyal USA SCHOENOCAULON OFFICINALE SEED 1 [hp_X]/1 N 20181231 62106-8812_1bdf0063-0486-4017-e054-00144ff8d46c 62106-8812 HUMAN OTC DRUG SABAL SERRULATA Saw palmetto GRANULE ORAL 20150727 UNAPPROVED HOMEOPATHIC Seroyal USA SAW PALMETTO 1 [hp_X]/1 N 20181231 62106-8814_26d37e41-4eae-1676-e054-00144ff8d46c 62106-8814 HUMAN OTC DRUG SABINA Savin GRANULE ORAL 20151213 UNAPPROVED HOMEOPATHIC Seroyal USA JUNIPERUS SABINA LEAFY TWIG 3 [hp_X]/1 N 20181231 62106-8835_1aeec72a-e245-181a-e054-00144ff8d46c 62106-8835 HUMAN OTC DRUG SAMBUCUS NIGRA European elder GRANULE ORAL 20150715 UNAPPROVED HOMEOPATHIC Seroyal USA SAMBUCUS NIGRA FLOWERING TOP 1 [hp_X]/1 N 20181231 62106-8837_18585dcb-326d-0be0-e054-00144ff88e88 62106-8837 HUMAN OTC DRUG SANGUINARIA CANADENSIS Bloodroot GRANULE ORAL 20150612 UNAPPROVED HOMEOPATHIC Seroyal USA SANGUINARIA CANADENSIS ROOT 3 [hp_X]/1 N 20181231 62106-8848_12235035-3e49-60dc-e054-00144ff88e88 62106-8848 HUMAN OTC DRUG SARSAPARILLA Sarsaparilla GRANULE ORAL 20150325 UNAPPROVED HOMEOPATHIC Seroyal USA SMILAX REGELII ROOT 1 [hp_X]/1 N 20181231 62106-8878_20fe1d4e-a1e0-0ab4-e054-00144ff8d46c 62106-8878 HUMAN OTC DRUG SECALE CORNUTUM Rye ergot GRANULE ORAL 20150930 UNAPPROVED HOMEOPATHIC Seroyal USA CLAVICEPS PURPUREA SCLEROTIUM 3 [hp_X]/1 N 20181231 62106-8945_0de1b20b-39a4-1302-e054-00144ff88e88 62106-8945 HUMAN OTC DRUG SOLIDAGO VIRGAUREA Goldenrod GRANULE ORAL 20150130 UNAPPROVED HOMEOPATHIC Seroyal USA SOLIDAGO VIRGAUREA FLOWERING TOP 1 [hp_X]/1 N 20181231 62106-8958_11bb8608-b5bc-63e9-e054-00144ff8d46c 62106-8958 HUMAN OTC DRUG Spigelia Anthelmia Pink root GRANULE ORAL 20150320 UNAPPROVED HOMEOPATHIC Seroyal USA SPIGELIA ANTHELMIA 2 [hp_X]/1 N 20181231 62106-8972_0de33df6-aac7-13a7-e054-00144ff8d46c 62106-8972 HUMAN OTC DRUG STAPHYSAGRIA Stavesacre GRANULE ORAL 20150130 UNAPPROVED HOMEOPATHIC Seroyal USA DELPHINIUM STAPHISAGRIA SEED 4 [hp_X]/1 N 20181231 62106-8982_1be0f52e-1672-18f3-e054-00144ff8d46c 62106-8982 HUMAN OTC DRUG STRAMONIUM Thorn apple GRANULE ORAL 20150727 UNAPPROVED HOMEOPATHIC Seroyal USA DATURA STRAMONIUM 3 [hp_X]/1 N 20181231 62106-9001_0de43bc0-3516-6a83-e054-00144ff88e88 62106-9001 HUMAN OTC DRUG SYMPHYTUM OFFICINALE Comfrey GRANULE ORAL 20150130 UNAPPROVED HOMEOPATHIC Seroyal USA COMFREY ROOT 1 [hp_X]/1 N 20181231 62106-9003_172ac837-0d32-1f5c-e054-00144ff88e88 62106-9003 HUMAN OTC DRUG SYZYGIUM JAMBOLANUM Jambol seed GRANULE ORAL 20150528 UNAPPROVED HOMEOPATHIC Seroyal USA SYZYGIUM CUMINI SEED 3 [hp_X]/1 N 20181231 62106-9019_184242fa-91d2-53b0-e054-00144ff88e88 62106-9019 HUMAN OTC DRUG TARAXACUM OFFICINALE Common dandelion GRANULE ORAL 20150611 UNAPPROVED HOMEOPATHIC Seroyal USA TARAXACUM OFFICINALE 1 [hp_X]/1 N 20181231 62106-9052_44593745-52d2-0b33-e054-00144ff88e88 62106-9052 HUMAN OTC DRUG THUJA OCCIDENTALIS White cedar GRANULE ORAL 20150320 UNAPPROVED HOMEOPATHIC Seroyal USA THUJA OCCIDENTALIS LEAFY TWIG 1 [hp_X]/1 N 20181231 62106-9118_1be0ef71-53fd-1c38-e054-00144ff8d46c 62106-9118 HUMAN OTC DRUG URTICA URENS Dwarf nettle GRANULE ORAL 20150727 UNAPPROVED HOMEOPATHIC Seroyal USA URTICA URENS 1 [hp_X]/1 N 20181231 62106-9130_173eac38-94ed-5b3d-e054-00144ff88e88 62106-9130 HUMAN OTC DRUG VALERIANA OFFICINALIS Valerian GRANULE ORAL 20150529 UNAPPROVED HOMEOPATHIC Seroyal USA VALERIAN 1 [hp_X]/1 N 20181231 62106-9135_173a4554-eca5-68d8-e054-00144ff8d46c 62106-9135 HUMAN OTC DRUG VERATRUM ALBUM White hellebore GRANULE ORAL 20150529 UNAPPROVED HOMEOPATHIC Seroyal USA VERATRUM ALBUM ROOT 3 [hp_X]/1 N 20181231 62106-9173_26d3c0c5-f837-176b-e054-00144ff8d46c 62106-9173 HUMAN OTC DRUG VIOLA TRICOLOR Pansy GRANULE ORAL 20151213 UNAPPROVED HOMEOPATHIC Seroyal USA VIOLA TRICOLOR 1 [hp_X]/1 N 20181231 62106-9911_52e1f6ff-f4ba-693a-e054-00144ff8d46c 62106-9911 HUMAN OTC DRUG FEBRIPLEX Aconitum napellus, Arnica montana, Belladonna, Eupatorium perfoliatum, Gelsemium sempervirens, Mercurius solubilis, Rhus toxicodendron TABLET ORAL 20170626 UNAPPROVED HOMEOPATHIC Seroyal USA ACONITUM NAPELLUS; ARNICA MONTANA ROOT; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; MERCURIUS SOLUBILIS; TOXICODENDRON PUBESCENS SHOOT 6; 8; 8; 10; 12; 10; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62106-9916_22b7eafe-ef77-0677-e054-00144ff88e88 62106-9916 HUMAN OTC DRUG MEDULLOSSEINUM PLEX Arnica montana, Calcarea phosphorica, Calendula officinalis, Hypericum perforatum, Medullosseinum, Pulsatilla, Ruta graveolens, Symphytum officinale LIQUID ORAL 20151022 UNAPPROVED HOMEOPATHIC Seroyal USA HYPERICUM PERFORATUM; ARNICA MONTANA ROOT; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; COMFREY ROOT; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; CALENDULA OFFICINALIS FLOWERING TOP; ORYCTOLAGUS CUNICULUS SPINAL CORD 5; 5; 4; 5; 5; 5; 5; 7 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL N 20181231 62107-002_61d11aaf-0a28-bfdd-e053-2a91aa0a4cd0 62107-002 HUMAN OTC DRUG HEALTH SENSE PROVIL ibuprofen TABLET, FILM COATED ORAL 20060101 ANDA ANDA075010 Prime Marketing, LLC IBUPROFEN 200 mg/1 N 20191231 62107-026_61d22e64-d46c-ed0f-e053-2a91aa0a000f 62107-026 HUMAN OTC DRUG HEALTH SENSE Adult Chewable Low Strength Aspirin Aspirin TABLET, CHEWABLE ORAL 20061001 OTC MONOGRAPH NOT FINAL part343 Prime Marketing, LLC ASPIRIN 81 mg/1 N 20191231 62107-027_0ae75975-fa66-5cf6-e054-00144ff8d46c 62107-027 HUMAN OTC DRUG HEALTH SENSE ASPIRIN 81 Aspirin TABLET, COATED ORAL 20060701 OTC MONOGRAPH FINAL part343 Prime Marketing, LLC ASPIRIN 81 mg/1 N 20181231 62107-028_0af864ea-11dc-4b25-e054-00144ff8d46c 62107-028 HUMAN OTC DRUG HEALTH SENSE ECPIRIN Aspirin TABLET, COATED ORAL 20061201 OTC MONOGRAPH FINAL part343 Prime Marketing, LLC ASPIRIN 325 mg/1 N 20181231 62107-030_0a66d57a-4343-5c87-e054-00144ff88e88 62107-030 HUMAN OTC DRUG HEALTH SENSE DUCODYL Bisacodyl TABLET, COATED ORAL 20060701 OTC MONOGRAPH NOT FINAL part334 Prime Marketing, LLC BISACODYL 5 mg/1 N 20181231 62107-031_0a6f69bf-744e-5e18-e054-00144ff8d46c 62107-031 HUMAN OTC DRUG HEALTH SENSE SENNO Sennosides TABLET ORAL 20051101 OTC MONOGRAPH NOT FINAL part334 Prime Marketing, LLC SENNOSIDES 8.6 mg/1 N 20181231 62107-033_0a6a5f56-3922-53b1-e054-00144ff8d46c 62107-033 HUMAN OTC DRUG HEALTH SENSE DOCUSIL Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20070901 OTC MONOGRAPH NOT FINAL part334 Prime Marketing, LLC DOCUSATE SODIUM 100 mg/1 E 20171231 62107-050_5f0f6b11-5a44-d7ce-e053-2991aa0a1c0c 62107-050 HUMAN OTC DRUG HEALTH SENSE TACTINAL Extra Strength Acetaminophen TABLET ORAL 20060801 OTC MONOGRAPH NOT FINAL part343 Prime Marketing, LLC ACETAMINOPHEN 500 mg/1 N 20181231 62107-051_0a5b8720-dec6-4cb2-e054-00144ff88e88 62107-051 HUMAN OTC DRUG HEALTH SENSE TACTINAL Extra Strength Acetaminophen TABLET ORAL 20060801 OTC MONOGRAPH NOT FINAL part343 Prime Marketing, LLC ACETAMINOPHEN 500 mg/1 N 20181231 62107-052_0a46ce49-e271-6177-e054-00144ff88e88 62107-052 HUMAN OTC DRUG HEALTH SENSE TACTINAL Regular Strength Acetaminophen TABLET ORAL 20060801 OTC MONOGRAPH NOT FINAL part343 Prime Marketing, LLC ACETAMINOPHEN 325 mg/1 N 20181231 62111-0210_7882cc7e-d04e-4565-8366-b1ebf167aed8 62111-0210 HUMAN OTC DRUG LIP ENHANCER GLOSS SUNSCREEN BROAD SPECTRUM SPF15 AVOBENZONE, OCTINOXATE, OCTISALATE GEL TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 AKG Innovations LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 30 mg/mL; mg/mL; mg/mL N 20181231 62111-0211_0266a461-597c-4ad7-999c-9e070c2e063f 62111-0211 HUMAN OTC DRUG Moisturizing Lip BalmSPF30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part352 AKG Innovations LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25; 80; 50; 22; 30 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 62111-0212_31539b3c-ad6e-4c7f-b464-2c5ed6daa711 62111-0212 HUMAN OTC DRUG PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH Sodium Fluoride MOUTHWASH ORAL 20140214 OTC MONOGRAPH FINAL part355 AKG Innovations LLC SODIUM FLUORIDE .2 mg/mL E 20171231 62111-0213_7a426e80-7e89-4f1e-8c92-0c6c09abd0ac 62111-0213 HUMAN OTC DRUG PROFESSIONAL WHITENING SYSTEM WHITENING SODIUM FLUORIDE PASTE DENTAL 20140214 OTC MONOGRAPH FINAL part355 AKG Innovations LLC SODIUM FLUORIDE .23 g/100g E 20171231 62112-8045_5d8e5780-ec4b-f646-e053-2991aa0a4b12 62112-8045 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 20090801 ANDA ANDA072781 Intergel Pharmaceuticals Inc NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 62112-8068_2f4a4ce5-53b2-7457-e054-00144ff88e88 62112-8068 HUMAN PRESCRIPTION DRUG Dutasteride dutasteride CAPSULE, LIQUID FILLED ORAL 20021210 ANDA ANDA206373 Intergel Pharmaceuticals Inc DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 62118-001_3ef99746-3aff-4a8b-b456-2e3c43382a9a 62118-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20150303 NDA NDA206023 Mountain Aire Medical Supply, Inc OXYGEN 1 L/L N 20181231 62135-225_84037bce-9214-4593-96ef-e23668f07d7f 62135-225 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20151214 ANDA ANDA062752 Chartwell RX, LLC TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 62135-266_84037bce-9214-4593-96ef-e23668f07d7f 62135-266 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20151214 ANDA ANDA062752 Chartwell RX, LLC TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 62135-626_f627af7f-8833-43a9-a75d-dc921d81938a 62135-626 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 Chartwell RX LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 62135-984_658d2c94-00b5-434c-a98c-6e4e0eee274f 62135-984 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Chartwell RX LLC DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 62135-985_658d2c94-00b5-434c-a98c-6e4e0eee274f 62135-985 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Chartwell RX LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 62137-001_642ebb98-d280-188b-e053-2a91aa0a0a69 62137-001 HUMAN PRESCRIPTION DRUG Oxygen OXYGEN LIQUID RESPIRATORY (INHALATION) 19950501 NDA NDA205889 AMO Medical Oxygen, Inc. OXYGEN 1000 g/L N 20191231 62137-002_642ec89f-4ba5-68cd-e053-2991aa0a6a5c 62137-002 HUMAN PRESCRIPTION DRUG Oxygen OXYGEN GAS RESPIRATORY (INHALATION) 19950501 NDA NDA205889 AMO Medical Oxygen, Inc. OXYGEN 1 L/L N 20191231 62144-5510_2b072821-c4b6-4267-a6b1-844536e0b7e8 62144-5510 HUMAN OTC DRUG ImproVue HYPROMELLOSE 2208 (15000 MPA.S) SOLUTION/ DROPS OPHTHALMIC 20140625 OTC MONOGRAPH FINAL part349 Oculus Surgical, Inc. HYPROMELLOSE 2208 (15000 MPA.S) 17 mg/mL E 20171231 62145-001_5bd391b2-e9f8-1bed-e053-2991aa0a0bfb 62145-001 HUMAN PRESCRIPTION DRUG Oxygen Refrigerated Liquid Oxygen Refrigerated Liquid GAS RESPIRATORY (INHALATION) 20071018 UNAPPROVED MEDICAL GAS Dallas Life Support Systems Inc OXYGEN 999 mL/L N 20181231 62145-002_5bd391b2-e9f8-1bed-e053-2991aa0a0bfb 62145-002 HUMAN PRESCRIPTION DRUG Oxygen Compressed Gas Oxygen Compressed Gas GAS RESPIRATORY (INHALATION) 20071018 UNAPPROVED MEDICAL GAS Dallas Life Support Systems Inc OXYGEN 995 mL/L N 20181231 62149-0002_39f9447a-f7c9-4c90-a3de-55577eff4b3c 62149-0002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930101 UNAPPROVED MEDICAL GAS A.M. Home Diagnostics Inc. dba Healthline OXYGEN 99 L/100L E 20171231 62168-0084_8b05c7df-9140-4292-9aad-b3302097caff 62168-0084 HUMAN OTC DRUG Icy Hot Medicated Menthol PATCH TOPICAL 20001101 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL, UNSPECIFIED FORM 205.5 mg/1 N 20181231 62168-0085_3d69bc86-aa79-4f06-ab39-59aa41f82b54 62168-0085 HUMAN OTC DRUG Dorflex Icy Hot Flexible, Small Menthol PATCH TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL 205.5 mg/1 E 20171231 62168-0086_3d69bc86-aa79-4f06-ab39-59aa41f82b54 62168-0086 HUMAN OTC DRUG Dorflex Icy Hot Flexible, Large Menthol PATCH TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL 428.5 mg/1 E 20171231 62168-0087_3d69bc86-aa79-4f06-ab39-59aa41f82b54 62168-0087 HUMAN OTC DRUG Dorflex Icy Hot Flexible, XL Menthol PATCH TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL 750 mg/1 E 20171231 62168-0584_764901b4-259d-4828-bc28-e56827001e53 62168-0584 HUMAN OTC DRUG Aspercreme Lidocaine PATCH TOPICAL 20160216 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. LIDOCAINE 246 mg/1 N 20181231 62168-0585_b1077b76-7ae7-4b1b-a972-c1b10e9671f9 62168-0585 HUMAN OTC DRUG Aspercreme Lidocaine XL Lidocaine PATCH TOPICAL 20171015 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co., Ltd. LIDOCAINE 411.4 mg/1 N 20181231 62168-0805_8b05c7df-9140-4292-9aad-b3302097caff 62168-0805 HUMAN OTC DRUG Icy Hot Medicated, Advanced Relief Menthol PATCH TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL, UNSPECIFIED FORM 210 mg/1 N 20181231 62168-0843_8b05c7df-9140-4292-9aad-b3302097caff 62168-0843 HUMAN OTC DRUG Icy Hot Medicated, Back Menthol PATCH TOPICAL 20030301 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL, UNSPECIFIED FORM 428.5 mg/1 N 20181231 62168-0847_8b05c7df-9140-4292-9aad-b3302097caff 62168-0847 HUMAN OTC DRUG Icy Hot Medicated, XL Menthol PATCH TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL, UNSPECIFIED FORM 750 mg/1 N 20181231 62168-0848_de3378c1-f6db-4532-9644-5e1543a38dc3 62168-0848 HUMAN OTC DRUG Icy Hot Medicated, Micro Menthol PATCH TOPICAL 20140807 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL, UNSPECIFIED FORM 29.3 mg/1 N 20191231 62168-1000_9df40679-e915-4cc7-9e5e-805a253d0e7f 62168-1000 HUMAN OTC DRUG Icy Hot Back Menthol PATCH TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. MENTHOL 428.5 mg/1 E 20171231 62168-1720_03543ab2-ffe2-43eb-bc1c-e24c98e66c3e 62168-1720 HUMAN OTC DRUG Icy Hot Lidocaine, Menthol PATCH TOPICAL 20170115 OTC MONOGRAPH NOT FINAL part348 Lead Chemical Co. Ltd. LIDOCAINE; MENTHOL, UNSPECIFIED FORM 240; 60 mg/1; mg/1 N 20181231 62169-202_35842aa1-812f-42c1-a7bf-3a40e58ddfee 62169-202 HUMAN OTC DRUG MANUGEL 85 Ethanol GEL TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Laboratoires Anios ALCOHOL; PHENOXYETHANOL 400; .3 mL/500mL; g/500mL E 20171231 62169-203_b39b4a9b-56e8-43f2-89d5-319b6cf2e337 62169-203 HUMAN OTC DRUG ANIOSGEL 85 NPC Ethanol GEL TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Laboratoires Anios ALCOHOL 377.5 mL/500mL E 20171231 62171-010_8fad41f4-6ca7-45a4-8df8-70a31061a3fa 62171-010 HUMAN OTC DRUG DR MYERS WATER KEEP SKINS OCTINOXATE CREAM TOPICAL 20140102 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. OCTINOXATE 3.75 mg/50mL N 20181231 62171-020_fd7b6468-5eaa-4ffd-9fc6-81e51010a2c1 62171-020 HUMAN OTC DRUG UV MILD SUN BLOCK OCTINOXATE CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. OCTINOXATE 3.75 mg/50mL N 20181231 62171-030_3fc805e4-186d-4186-9697-f978aa8e0fff 62171-030 HUMAN OTC DRUG SNAIL REPAIR BLEMISH BALM OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.82; 4.49; .38 mg/50mL; mg/50mL; mg/50mL N 20181231 62171-040_f1481a72-8926-4063-b8e9-d39b2b029f6e 62171-040 HUMAN OTC DRUG CRYSTAL MIRACLE MULTI OCTINOXATE CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. OCTINOXATE 3.75 mg/50mL N 20181231 62171-050_fcf80cb4-7763-4ab4-b60f-3103f3e48534 62171-050 HUMAN OTC DRUG STEBLANC WATER CC PACT 21 Light Beige Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.17; .91; .62; .26; .26 g/13g; g/13g; g/13g; g/13g; g/13g N 20181231 62171-060_5df2f2af-e89b-4a14-9813-dfb069575371 62171-060 HUMAN OTC DRUG STEBLANC WATER CC PACT 23 Natural Beige Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.17; .91; .62; .26; .26 g/13g; g/13g; g/13g; g/13g; g/13g N 20181231 62171-070_6c3bceef-cd4f-4dc0-8e12-c817c0640b80 62171-070 HUMAN OTC DRUG AGATHA FITTING TOUCH MAKE UP SET Octinoxate, Titanium Dioxide, Octisalate, Zinc Oxide POWDER TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 Coson Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE .67; .77; .45; .31 g/9g; g/9g; g/9g; g/9g N 20181231 62171-080_fe012e44-5d07-4774-b5db-ab1b2e93bb87 62171-080 HUMAN OTC DRUG GD11 ADVANCED LAB ENERGY AMPOULE Niacinamide, Adenosine LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER Coson Co., Ltd. NIACINAMIDE; ADENOSINE .16; .003 g/8mL; g/8mL N 20181231 62171-090_304b836a-d152-419c-9c37-58f202c64ac0 62171-090 HUMAN OTC DRUG GD11 Rx SCM S Niacinamide, Adenosine LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER Coson Co., Ltd. NIACINAMIDE; ADENOSINE .1; .002 g/5mL; g/5mL N 20181231 62171-100_bbc9fd79-64bd-4764-b770-eb6451853a2f 62171-100 HUMAN OTC DRUG GD11 Rx SCM C5 MANNITOL LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER Coson Co., Ltd. MANNITOL .1 g/2mL N 20181231 62172-202_909d3d19-78a4-4815-9197-fb9b268da610 62172-202 HUMAN OTC DRUG SKIN PROTECTOR WITH BREATHABLE BARRIER MICONAZOLE NITRATE CREAM TOPICAL 20160504 OTC MONOGRAPH FINAL part333C DIVERSIFIED MANUFACTURING CORP MICONAZOLE NITRATE 2 g/100g N 20181231 62172-203_f88f6554-1629-418b-9872-d48ac0ef719d 62172-203 HUMAN OTC DRUG DR H STABILIZER HYDROCORTISONE LOTION TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part348 DIVERSIFIED MANUFACTURING CORP HYDROCORTISONE .75 g/100mL E 20171231 62172-311_efad62dc-762a-45c3-9884-e490f9c46fa1 62172-311 HUMAN OTC DRUG EMBRACE ANTI-ITCH SKIN PROTECTANT WITH CALAMINE AND MENTHOL MENTHOL. ZINC OXIDE CREAM TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part348 DIVERSIFIED MANUFACTURING CORP MENTHOL; ZINC OXIDE .44; 20.6 g/100g; g/100g N 20181231 62175-106_ffc76368-b018-4a05-9c01-602593e33a2d 62175-106 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET ORAL 19930630 NDA AUTHORIZED GENERIC NDA020215 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 62175-107_ffc76368-b018-4a05-9c01-602593e33a2d 62175-107 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET ORAL 19930630 NDA AUTHORIZED GENERIC NDA020215 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 62175-114_766cfcaf-330e-4297-a782-8ad74747e9a5 62175-114 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20030903 ANDA ANDA075410 Kremers Urban Pharmaceuticals Inc. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 62175-118_766cfcaf-330e-4297-a782-8ad74747e9a5 62175-118 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 Kremers Urban Pharmaceuticals Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 62175-119_bf0366d3-e0ce-4936-b6dd-44d26f907f45 62175-119 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 62175-123_6a6fb426-9ed2-4741-921b-2b8102b6ab29 62175-123 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin FILM, EXTENDED RELEASE TRANSDERMAL 20040810 ANDA ANDA075115 Kremers Urban Pharmaceuticals Inc. NITROGLYCERIN 20.8 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 62175-124_6a6fb426-9ed2-4741-921b-2b8102b6ab29 62175-124 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin FILM, EXTENDED RELEASE TRANSDERMAL 20040810 ANDA ANDA075115 Kremers Urban Pharmaceuticals Inc. NITROGLYCERIN 37.4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 62175-128_bf0366d3-e0ce-4936-b6dd-44d26f907f45 62175-128 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 62175-129_bf0366d3-e0ce-4936-b6dd-44d26f907f45 62175-129 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 62175-136_766cfcaf-330e-4297-a782-8ad74747e9a5 62175-136 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090123 ANDA ANDA075410 Kremers Urban Pharmaceuticals Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 62175-151_61b09a60-9f35-41ae-8b90-620589ef32f9 62175-151 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030812 NDA AUTHORIZED GENERIC NDA021259 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 62175-152_61b09a60-9f35-41ae-8b90-620589ef32f9 62175-152 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030218 NDA AUTHORIZED GENERIC NDA021259 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 62175-153_61b09a60-9f35-41ae-8b90-620589ef32f9 62175-153 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030722 NDA AUTHORIZED GENERIC NDA021259 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 62175-154_61b09a60-9f35-41ae-8b90-620589ef32f9 62175-154 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA AUTHORIZED GENERIC NDA021259 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 62175-155_61b09a60-9f35-41ae-8b90-620589ef32f9 62175-155 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA AUTHORIZED GENERIC NDA021259 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 62175-156_61b09a60-9f35-41ae-8b90-620589ef32f9 62175-156 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA AUTHORIZED GENERIC NDA021259 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 62175-180_bf8330ec-6758-4c41-bc86-37cb65e217c4 62175-180 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Lannett Company, Inc.. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 62175-190_4e268f6d-be5c-4bd1-b384-2d0ce70e7e24 62175-190 HUMAN OTC DRUG GlycoLax Osmotic Laxative Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091006 ANDA ANDA090600 Kremers Urban Pharmaceuticals Inc. POLYETHYLENE GLYCOL 3350 17 g/17g E 20171231 62175-195_2fb5d413-e4c6-4edb-afb3-683b60c32ef0 62175-195 HUMAN OTC DRUG Polyethylene Glycol 3350 Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091006 ANDA ANDA090600 Kremers Urban POLYETHYLENE GLYCOL 3350 17 g/17g E 20171231 62175-204_4bfdbc17-a0e4-482d-90bc-cef328e4cdbf 62175-204 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA200405 Kremers Urban Pharmaceuticals Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 62175-205_4bfdbc17-a0e4-482d-90bc-cef328e4cdbf 62175-205 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA200405 Kremers Urban Pharmaceuticals Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 62175-210_4bfdbc17-a0e4-482d-90bc-cef328e4cdbf 62175-210 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA201522 Kremers Urban Pharmaceuticals Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 62175-240_b08319b1-c1c5-4351-9929-e1495b79aebc 62175-240 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160210 ANDA ANDA203898 Lannett Company, Inc.. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 62175-241_b08319b1-c1c5-4351-9929-e1495b79aebc 62175-241 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160210 ANDA ANDA203898 Lannett Company, Inc.. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 62175-242_b08319b1-c1c5-4351-9929-e1495b79aebc 62175-242 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160210 ANDA ANDA203898 Lannett Company, Inc.. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 62175-243_b08319b1-c1c5-4351-9929-e1495b79aebc 62175-243 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160210 ANDA ANDA203898 Lannett Company, Inc.. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 62175-244_b08319b1-c1c5-4351-9929-e1495b79aebc 62175-244 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160210 ANDA ANDA203898 Lannett Company, Inc.. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 62175-245_b08319b1-c1c5-4351-9929-e1495b79aebc 62175-245 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20160210 ANDA ANDA203898 Lannett Company, Inc.. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 62175-260_5f110323-cd7a-4e10-e053-2991aa0a7b57 62175-260 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Kremers Urban Pharmaceuticals Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 62175-261_5f110323-cd7a-4e10-e053-2991aa0a7b57 62175-261 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Kremers Urban Pharmaceuticals Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 62175-262_5f110323-cd7a-4e10-e053-2991aa0a7b57 62175-262 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071003 ANDA ANDA077410 Kremers Urban Pharmaceuticals Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 62175-270_3e10de72-51ba-08e7-e054-00144ff8d46c 62175-270 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 Kremers Urban Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 62175-271_3e10de72-51ba-08e7-e054-00144ff8d46c 62175-271 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 Kremers Urban Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 62175-272_3e10de72-51ba-08e7-e054-00144ff8d46c 62175-272 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 Kremers Urban Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 62175-302_83a07554-cda6-48b3-8c0a-28e98c111c90 62175-302 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA090678 Kremers Urban Pharmaceuticals Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 62175-310_35fcfe87-9024-4686-83f1-0b5d4589c9c0 62175-310 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130710 ANDA ANDA091695 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 62175-311_35fcfe87-9024-4686-83f1-0b5d4589c9c0 62175-311 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130710 ANDA ANDA091695 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 62175-312_35fcfe87-9024-4686-83f1-0b5d4589c9c0 62175-312 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130923 ANDA ANDA091695 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 62175-313_35fcfe87-9024-4686-83f1-0b5d4589c9c0 62175-313 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20130923 ANDA ANDA091695 Kremers Urban Pharmaceuticals Inc. METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 62175-320_ebdca6ef-bb6a-4ebb-86de-54f616538f42 62175-320 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20170216 ANDA ANDA203899 Lannett Company, Inc.. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 62175-322_ebdca6ef-bb6a-4ebb-86de-54f616538f42 62175-322 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20170216 ANDA ANDA203899 Lannett Company, Inc.. NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 62175-361_051c2183-7e60-4bf3-b342-09d940d7bd91 62175-361 HUMAN PRESCRIPTION DRUG Monoket isosorbide mononitrate TABLET ORAL 19930630 NDA NDA020215 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 62175-362_051c2183-7e60-4bf3-b342-09d940d7bd91 62175-362 HUMAN PRESCRIPTION DRUG Monoket isosorbide mononitrate TABLET ORAL 19930630 NDA NDA020215 Kremers Urban Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 62175-380_3a86a36e-029d-fded-1f9c-79177d3aaab6 62175-380 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20150730 ANDA ANDA090802 Kremers Urban Pharmaceuticals Inc. TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] E 20171231 62175-381_3a86a36e-029d-fded-1f9c-79177d3aaab6 62175-381 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20150730 ANDA ANDA090802 Kremers Urban Pharmaceuticals Inc. TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] E 20171231 62175-382_3a86a36e-029d-fded-1f9c-79177d3aaab6 62175-382 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20150730 ANDA ANDA090802 Kremers Urban Pharmaceuticals Inc. TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] E 20171231 62175-415_630a37f1-8f69-4033-b2c7-d78d164bb525 62175-415 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20170928 ANDA ANDA207156 Lannett Company, Inc.. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 62175-430_630a37f1-8f69-4033-b2c7-d78d164bb525 62175-430 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20170928 ANDA ANDA207156 Lannett Company, Inc.. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 62175-442_88c8bb0f-3709-4508-947d-0755c7ec7647 62175-442 HUMAN PRESCRIPTION DRUG POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 POWDER ORAL 20111001 ANDA ANDA076652 Kremers Urban Pharmaceuticals Inc. POLYETHYLENE GLYCOL 3350 1 g/g Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 62175-446_cd812ad9-6f77-4c30-b736-97ada7e29063 62175-446 HUMAN PRESCRIPTION DRUG PEG-3350 and Electrolytes POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, and SODIUM SULFATE POWDER, FOR SOLUTION ORAL 19841026 NDA AUTHORIZED GENERIC NDA018983 Kremers Urban Pharmaceuticals Inc. POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM SULFATE 240; 5.84; 2.98; 6.72; 22.72 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 62175-452_8e3452b1-6b57-4aa0-aac8-636dfca8b3b4 62175-452 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone Buprenorphine and Naloxone TABLET SUBLINGUAL 20160919 ANDA ANDA205022 Lannett Company, Inc.. BUPRENORPHINE; NALOXONE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 62175-458_8e3452b1-6b57-4aa0-aac8-636dfca8b3b4 62175-458 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone Buprenorphine and Naloxone TABLET SUBLINGUAL 20160919 ANDA ANDA205022 Lannett Company, Inc.. BUPRENORPHINE; NALOXONE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 62175-470_8efb36ce-9c55-4ad4-a8dc-07627e01b07b 62175-470 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141031 ANDA ANDA204744 Kremers Urban Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62175-471_8efb36ce-9c55-4ad4-a8dc-07627e01b07b 62175-471 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141031 ANDA ANDA204744 Kremers Urban Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62175-472_8efb36ce-9c55-4ad4-a8dc-07627e01b07b 62175-472 HUMAN PRESCRIPTION DRUG Paroxetine Hydrochloride Paroxetine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20141031 ANDA ANDA204744 Kremers Urban Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62175-485_1b1067c8-5098-4589-b0aa-b76d3388b5b6 62175-485 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 100 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 62175-486_1b1067c8-5098-4589-b0aa-b76d3388b5b6 62175-486 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 200 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 62175-487_1b1067c8-5098-4589-b0aa-b76d3388b5b6 62175-487 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 62175-490_b1bbc13b-f00c-4337-a3dc-f08591620742 62175-490 HUMAN PRESCRIPTION DRUG Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetic hydrocodone polistirex and chlorpheniramine polistirex SUSPENSION, EXTENDED RELEASE ORAL 19871231 NDA AUTHORIZED GENERIC NDA019111 Kremers Urban Pharmaceuticals Inc. HYDROCODONE; CHLORPHENIRAMINE 10; 8 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII N 20181231 62175-515_49f0da45-a5d5-4bda-9a44-1ddfe4a776d5 62175-515 HUMAN OTC DRUG Lansoprazole 24 HR Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20170929 ANDA ANDA207157 Lannett Company, Inc.. LANSOPRAZOLE 15 mg/1 N 20181231 62175-570_6e2f5763-a11d-4a75-9fa5-cc953ed5a008 62175-570 HUMAN PRESCRIPTION DRUG VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 100 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62175-571_6e2f5763-a11d-4a75-9fa5-cc953ed5a008 62175-571 HUMAN PRESCRIPTION DRUG VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 200 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62175-572_6e2f5763-a11d-4a75-9fa5-cc953ed5a008 62175-572 HUMAN PRESCRIPTION DRUG VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62175-580_a50b30fb-374b-4d1c-80fa-5bee04b5cc8f 62175-580 HUMAN PRESCRIPTION DRUG VERELAN verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62175-581_a50b30fb-374b-4d1c-80fa-5bee04b5cc8f 62175-581 HUMAN PRESCRIPTION DRUG VERELAN verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62175-582_a50b30fb-374b-4d1c-80fa-5bee04b5cc8f 62175-582 HUMAN PRESCRIPTION DRUG VERELAN verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62175-583_a50b30fb-374b-4d1c-80fa-5bee04b5cc8f 62175-583 HUMAN PRESCRIPTION DRUG VERELAN verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Kremers Urban Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62175-617_bf8330ec-6758-4c41-bc86-37cb65e217c4 62175-617 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Lannett Company, Inc.. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 62175-710_13fc4e17-f66a-4835-86d7-74ac6492f443 62175-710 HUMAN PRESCRIPTION DRUG Anastrozole anastrozole TABLET, FILM COATED ORAL 20110105 ANDA ANDA091331 Kremers Urban Pharmaceuticals Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 62175-820_4ebdcb50-c388-4f72-9093-4363362fd939 62175-820 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE PELLETS ORAL 20160401 ANDA ANDA205563 Lannett Company, Inc.. ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 62175-840_4ebdcb50-c388-4f72-9093-4363362fd939 62175-840 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE PELLETS ORAL 20160401 ANDA ANDA205563 Lannett Company, Inc.. ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 62175-890_b93fdf06-dacf-418a-b190-4767e7ce8535 62175-890 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Kremers Urban Pharmaceuticals Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 62175-891_b93fdf06-dacf-418a-b190-4767e7ce8535 62175-891 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Kremers Urban Pharmaceuticals Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 62175-892_b93fdf06-dacf-418a-b190-4767e7ce8535 62175-892 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Kremers Urban Pharmaceuticals Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 62175-897_b93fdf06-dacf-418a-b190-4767e7ce8535 62175-897 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Kremers Urban Pharmaceuticals Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 62179-1234_8fe5264f-40c4-48c4-a238-2fe613d49fc4 62179-1234 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140718 UNAPPROVED MEDICAL GAS Intermountain Home Care OXYGEN 1 L/L E 20171231 62185-0001_22899d14-4c7b-47dd-bb45-c3dc27e29c67 62185-0001 HUMAN OTC DRUG Emotional Eating Thyroidinum (suis), Cortisone aceticum, Anacardium orientale, Antimonium crudum, Ignatia amara, Natrum muriaticum, Staphysagria, Hydrocortisone (cortisol). LIQUID ORAL 20140311 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC SUS SCROFA THYROID; CORTISONE ACETATE; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; DELPHINIUM STAPHISAGRIA SEED; HYDROCORTISONE 12; 12; 15; 15; 15; 15; 18; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0002_861a77b5-cd39-4373-ba4f-512e7bf020ec 62185-0002 HUMAN OTC DRUG Professional Weight Maintenance Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Gambogia, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto-Dhea (Dehydroepiandrosterone), ATP (Adenosine Triphosphate Disodium), Glucagon, Insulinum, Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20140414 20190318 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; GAMBOGE; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN HUMAN; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62185-0003_d2780001-1c28-4ee7-8f80-e5c6b21daad4 62185-0003 HUMAN OTC DRUG WLP40 Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Brain (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), AACG-A, AACG-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto DHEA (Dehydroepiandrosterone), ATP (Adenosine Triphosphate, Disodium), Glucagon, Insulinum, Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20140408 20190319 UNAPPROVED HOMEOPATHIC Dr.Donna Resivo DC CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN HUMAN; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62185-0004_8d7632b1-3238-4fd4-a773-e9789f3013ec 62185-0004 HUMAN OTC DRUG Sugar Cravings Cinnamic Acid, Phloridzinum, Argentum Nitricum, Adenosinum Triphosphoricum Dinatrum, Beet Sugar, Dextrose, D-Ribose, Fructose, Grape Sugar (Syrup), Lycopodium Clavatum, Maple Sugar, Saccharum Lactis, Saccharum Officinale, Sarcolacticum Acidum, Adrenocorticotrophin, Malvin, Dysentery Bacillus, Morgan Gaertner LIQUID ORAL 20140410 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC CINNAMIC ACID; PHLORIZIN; SILVER NITRATE; ADENOSINE TRIPHOSPHATE DISODIUM; SUCROSE; DEXTROSE; RIBOSE, D-; FRUCTOSE; LYCOPODIUM CLAVATUM SPORE; ACER SACCHARUM SAP; LACTOSE; LACTIC ACID, L-; CORTICOTROPIN; MALVIN; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 15; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0005_eef620b4-2751-4ef3-b2b1-058a593a6bec 62185-0005 HUMAN OTC DRUG Chip Cravings Coumarinum, Quercetin, Rutin, Bamboo, Barley, Corn, Cotton Seed, Flax Seed, Millet, Milo, Oat, Poppy Seed, Rice, Rye, Safflower, Sesame, Sorghum, Soybean, Sugarcane, Sunflower Seed, Wheat, Amaranth, Avena Sativa, Natrum Sulphuricum, Sarcolacticum Acidum, Triticum Repens, Adrenocorticotrophin, Sycotic Co Bacillus LIQUID ORAL 20140317 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC COUMARIN; QUERCETIN; RUTIN; BAMBUSA VULGARIS LEAF; BARLEY; CORN; LEVANT COTTON SEED; FLAX SEED; MILLET; SORGHUM BICOLOR WHOLE; OAT; ESCHSCHOLZIA CALIFORNICA; BROWN RICE; RYE; SAFFLOWER; SESAME SEED; SORGHUM; SOYBEAN; SUGARCANE; SUNFLOWER SEED; WHEAT; AMARANTH; AVENA SATIVA FLOWERING TOP; SODIUM SULFATE; LACTIC ACID, L-; ELYMUS REPENS ROOT; CORTICOTROPIN; ENTEROCOCCUS FAECALIS 6; 6; 6; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 9; 6; 6; 6; 6; 6; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0006_f1bca009-26ec-4642-9b67-1f51055ee38c 62185-0006 HUMAN OTC DRUG Bread Cravings Acetaldehyde, Coumarinum, Histaminum Hydrochloricum, Quercetin, Torula Cerevisiae, Candida Albicans, Candida Parapsilosis, Adrenocorticotrophin, Sarcolacticum Acidum, Sepia, Faecalis (Alkaligenes) LIQUID ORAL 20140410 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC ACETALDEHYDE; COUMARIN; HISTAMINE DIHYDROCHLORIDE; QUERCETIN; SACCHAROMYCES CEREVISIAE; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CORTICOTROPIN; LACTIC ACID, L-; SEPIA OFFICINALIS JUICE; ALCALIGENES FAECALIS 6; 6; 6; 6; 10; 12; 12; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0007_5de63c6d-4b40-4ea5-921c-fa2e694692e0 62185-0007 HUMAN OTC DRUG WLP40 Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Brain (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), Aacg-A, Aacg-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto Dhea (Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum, Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20141209 20201014 UNAPPROVED HOMEOPATHIC Dr.Donna Resivo DC CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62185-0008_258ea326-707e-437a-a453-bac6cc7e14c0 62185-0008 HUMAN OTC DRUG D1 Organ Support Carduus Marianus, Chelidonium Majus, Cinchona Officinalis, Lycopodium Clavatum, Taraxacum Officinale, Veratrum Album, Avena Sativa, Cynara Scolymus, Methylcobalamin, Menadione, Alpha Lipoicum Acidum, Hepar Suis, Colon (Suis), Duodenum (Suis), Gallbladder (Suis), Intestine (Suis), Lymph Node (Suis), Pancreas Suis, Thymus (Suis), Alpha Ketoglutaricum Acidum, Cholesterinum, Formicum Acidum, Glyoxal Trimer Dihydrate, Histaminum Hydrochloricum, Malic Acid, Natrum Oxalaceticum, Sulphur, Calcarea Carbonica LIQUID ORAL 20150305 20211123 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC MILK THISTLE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT; AVENA SATIVA FLOWERING TOP; CYNARA SCOLYMUS LEAF; METHYLCOBALAMIN; MENADIONE; .ALPHA.-LIPOIC ACID; PORK LIVER; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; PORK INTESTINE; SUS SCROFA LYMPH; SUS SCROFA PANCREAS; SUS SCROFA THYMUS; .ALPHA.-KETOGLUTARIC ACID; CHOLESTEROL; FORMIC ACID; GLYOXAL TRIMER DIHYDRATE; HISTAMINE DIHYDROCHLORIDE; MALIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; OROTIC ACID MONOHYDRATE; PROTEUS MORGANII; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 3; 4; 4; 4; 4; 4; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 13; 28; 7; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0009_e10d3630-5614-4431-877b-da53c0c9c480 62185-0009 HUMAN OTC DRUG D2 Organ Support Solidago Virgaurea, Baptisia Tinctoria, Berberis Vulgaris, Equisetum Hyemale, Argentum Nitricum, Cantharis, Capsicum Annuum, Cuprum Sulphuricum, Orthosiphon Stamineus, Pareira Brava, Sarsaparilla (Smilax Regelii), Terebinthina, Apis Venenum Purum, Barosma (Betulina), Mercurius Corrosivus, Pyelon (Suis), Ureter (Suis), Urethra (Suis), Urinary Bladder (Suis), Glyoxal Trimer Dihydrate, Hepar Sulphuris Calcareum, Natrum Pyruvicum, Quercetin, Colibacillinum Cum Natrum Muriaticum, Dysentery Bacillus LIQUID ORAL 20150917 20211123 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC SOLIDAGO VIRGAUREA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; SILVER NITRATE; LYTTA VESICATORIA; CAPSICUM; CUPRIC SULFATE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; TURPENTINE OIL; APIS MELLIFERA VENOM; AGATHOSMA BETULINA LEAF; MERCURIC CHLORIDE; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; GLYOXAL TRIMER DIHYDRATE; CALCIUM SULFIDE; SODIUM PYRUVATE; QUERCETIN; ESCHERICHIA COLI; SHIGELLA DYSENTERIAE 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62185-0010_e656cbaa-da36-4986-b0d6-55de9e52b4f9 62185-0010 HUMAN OTC DRUG D3 Organ Support Conium Maculatum, Dulcamara, Echinacea (Angustifolia), Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid, Coccus Cacti, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Pulsatilla (Vulgaris), Sarcolacticum Acidum, Lymph Node (Suis), Sulphur, Glandula Suprarenalis Suis, Phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (Suis), Spleen (Suis), Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Funiculus Umbilicalis Suis, Tonsil (Suis) LIQUID ORAL 20150306 20210713 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA ANGUSTIFOLIA; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; PULSATILLA VULGARIS; LACTIC ACID, L-; SUS SCROFA LYMPH; SULFUR; SUS SCROFA ADRENAL GLAND; PHENYLALANINE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA SPLEEN; CORTISONE ACETATE; MERCURIUS SOLUBILIS; BARIUM CARBONATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA TONSIL; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; LIOTHYRONINE; SUS SCROFA BONE MARROW; BISPHENOL A; BROMINE; CHLORINE; HYDROFLUORIC ACID; IODINE; ESCHERICHIA COLI 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 10; 10; 10; 10; 10; 13; 13; 6; 6; 9; 10; 12; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0011_df761cd9-e626-4703-b1df-582c319a6b17 62185-0011 HUMAN OTC DRUG Brain Support Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, Gaba (Gamma Aminobutyric Acid), Norepinephrine, Octopamine, Serotonin (Hydrochloride), Taurine, Adenosinum Cyclophosphoricum, Cerebrum (Suis), Diencephalon (Suis), Pineal Gland (Suis), Thalamus Opticus (Suis) LIQUID ORAL 20150227 20210713 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC ACETYLCHOLINE CHLORIDE; EPINEPHRINE; DOPAMINE HYDROCHLORIDE; .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; TAURINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62185-0012_53dab4d4-5802-4057-8f33-7abf249c5dcb 62185-0012 HUMAN OTC DRUG Chemdetox Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Glandula Suprarenalis Suis, Hepar Suis, Lymph Node (Suis), Throidinum (Suis), Belladonna, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum, Selenium Metallicum, Salicylicum Acidum, Adrenocorticotrophin, Cortisone Aceticum, Eugenol, Stearyl Alcohol, Xylitol, Folliculinum, Benzoicum Acidum, Chlorinum, Potassium Sorbate, Sorbitol, Resorcinum LIQUID ORAL 20150306 20210716 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA LYMPH; SUS SCROFA THYROID; ATROPA BELLADONNA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; SELENIUM; SALICYLIC ACID; CORTICOTROPIN; CORTISONE ACETATE; EUGENOL; STEARYL ALCOHOL; XYLITOL; ESTRONE; BENZOIC ACID; CHLORINE; POTASSIUM SORBATE; SORBITOL; RESORCINOL; BENZYL ALCOHOL; LACTIC ACID, DL-; ISOPROPYL PALMITATE; BORIC ACID; ACETIC ACID; PHENYL BUTYRATE; PETROLATUM; LEAD 3; 3; 3; 3; 3; 3; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62185-0013_56c423ee-384c-44c9-b0b1-8e909bb73be6 62185-0013 HUMAN OTC DRUG Insecticides/Pest/Food Additives Detox Beta Vulgaris, Boldo, Chelidonium Majus, Petroselinum Sativum, Taraxacum Officinale, Arsenicum Album, Belladonna, Cobaltum Metallicum, Cuprum Metallicum, Iodium, Lycopodium Clavatum, Phosphoricum Acidum, Selenium Metallicum, Zincum Metallicum, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methyl Paraben, Propyl Paraben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum LIQUID ORAL 20150309 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; PETROSELINUM CRISPUM; TARAXACUM OFFICINALE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; COBALT; COPPER; IODINE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; SELENIUM; ZINC; ASPARTAME; BENZALKONIUM CHLORIDE; FORMALDEHYDE; METHYLENE CHLORIDE; METHYLPARABEN; PROPYLPARABEN; SODIUM BENZOATE; SODIUM CITRATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62185-0014_bcf0770f-dccb-4f8b-b114-17face279063 62185-0014 HUMAN OTC DRUG Metdetox Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Ascorbic Acid, Cysteinum, Iridium Metallicum, Methionine, Selenium Metallicum, Thyroidinum (Suis), Carbolicum Acidum, Formalinum, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum LIQUID ORAL 20150805 20210310 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC GARLIC; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ASCORBIC ACID; CYSTEINE; IRIDIUM; METHIONINE; SUS SCROFA THYROID; PHENOL; FORMALDEHYDE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; LANTHANUM; NIOBIUM; TANTALUM 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 14; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0015_caa5df77-5262-4dfa-8196-90eba9cfe80a 62185-0015 HUMAN OTC DRUG Intercellular Detox Ceanothus Americanus, Hydrastis Canadensis, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (Vulgaris), Bile Duct (Suis), Colon (Suis), Duodenum (Suis), Esophagus (Suis), Eye (Suis), Gallbladder (Suis), Ileum (Suis), Intestine (Suis), Ipecacuanha, Jejunum (Suis), Kali Bichromicum, Lung (Suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (Suis), Pancreas Suis, Phosphorus, Rectal Mucosa (Suis), Stomach (Suis) LIQUID ORAL 20150302 20201014 UNAPPROVED HOMEOPATHIC Dr.Donna Resivo DC CEANOTHUS AMERICANUS LEAF; GOLDENSEAL; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; MARSDENIA CONDURANGO BARK; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PULSATILLA VULGARIS; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTUM; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; ATROPA BELLADONNA; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 4; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0016_84296787-016a-4f5a-b339-9d6862bc92d4 62185-0016 HUMAN OTC DRUG NS Support Berberis vulgaris, Cimicifuga racemosa, Cinchona officinalis, Colocynthis, Ledum palustre, Ranunculus bulbosus, Aesculus hippocastanum, Cuprum aceticum, Nadidum, Natrum oxalaceticum, Nicotinamidum, Picricum Acidum, Pyridoxinum hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Alpha-lipoicum Acidum, Ammonium muriaticum, Cartilago suis, Discus intervertebralis (suis), Silicea, Argentum metallicum, Calcarea phosphorica, Coenzyme A, Funiculus umbilicalis suis, Glandula suprarenalis suis, LIQUID ORAL 20150302 20201014 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; CUPRIC ACETATE; NADIDE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PICRIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; .ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; COENZYME A; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SUS SCROFA BONE MARROW; MERCURIC OXIDE; SULFUR; ENTEROBACTER CLOACAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII; PROTEUS VULGARIS 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 28; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0017_493c8ed4-a490-4af9-8cd5-9b19cbc1fd2d 62185-0017 HUMAN OTC DRUG Metdetox Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Ascorbic Acid, Cysteinum, Methionine, Thyroidinum (Suis), Calcarea Phosphorica, Chromium Metallicum, Cobaltum Metallicum, Cuprum Metallicum, Ferrum Metallicum, Iodium, Iridium Metallicum, Kali Carbonicum, Lithium Carbonicum, Magnesium Metallicum, Manganum Metallicum, Molybdenum, Natrum Muriaticum, Phosphorus, Selenium Metallicum, Strontium Carbonicum, Sulphur, LIQUID ORAL 20160331 20210713 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC GARLIC; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ASCORBIC ACID; CYSTEINE; METHIONINE; THYROID, PORCINE; TRIBASIC CALCIUM PHOSPHATE; CHROMIUM; COBALT; COPPER; IRON; IODINE; IRIDIUM; POTASSIUM CARBONATE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MOLYBDENUM; SODIUM CHLORIDE; PHOSPHORUS; SELENIUM; STRONTIUM CARBONATE; SULFUR; VANADIUM; ZINC; PHENOL; FORMALDEHYDE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; BORON; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BROMINE; CADMIUM; CERIUM; CESIUM; DYSPROSIUM; ERBIUM; EUROPIUM; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; NEODYMIUM; NICKEL; OSMIUM; PALLADIUM; PLATINUM; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM; TIN; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; YTTERBIUM OXIDE; ARSENIC TRIOXIDE; MERCURIUS SOLUBILIS; LEAD; LANTHANUM; NIOBIUM; TANTALUM 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 1000; 1000; 1000; 14; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0018_641ff648-5948-4412-ad2a-8ea4b2e6cdfd 62185-0018 HUMAN OTC DRUG Hormone Balance Salsolinol Hydrochloride, Cholesterinum, DHEA (Dehydroepiandrosterone), 7-Keto (3-Acetyl-7-Oxo-Dehydroepiandrosterone), Folliculinum, Oophorinum (Suis), Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone LIQUID ORAL 20160413 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC SALSOLINOL HYDROCHLORIDE, (+/-)-; CHOLESTEROL; PRASTERONE; 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE; ESTRONE; SUS SCROFA OVARY; PROGESTERONE; TESTOSTERONE; CORTISONE ACETATE; ALDOSTERONE; ANDROSTERONE; FOLLITROPIN 6; 6; 6; 8; 8; 8; 8; 8; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0019_b38389dd-41e9-46ba-a554-1ce3a3ac28eb 62185-0019 HUMAN OTC DRUG HGH Young Again Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-Dopa, Melatonin, Testosterone, Adenosinum Triphosphoricum, Dinatrum, Alpha-Lipoicum Acidum, Nadidum, Pantothenic Acid, Sarcolacticum Acidum, Ubidecarenonum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (Suis), Lymph Node (Suis), Medulla Ossis Suis, Oophorinum (Suis), Orchitinum (Suis), Pancreas Suis, Spleen (Suis), Human Growth Hormone LIQUID ORAL 20160422 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC CHASTE TREE; AMBERGRIS; CONIUM MACULATUM FLOWERING TOP; APIOLE (PARSLEY); ESTRADIOL; ESTRIOL; ESTRONE; LEVODOPA; MELATONIN; TESTOSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; THIOCTIC ACID; NADIDE; PANTOTHENIC ACID; LACTIC ACID, L-; UBIDECARENONE; BARIUM CARBONATE; SELENIUM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SOMATROPIN; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62185-0020_87017ecf-1e1c-4c05-a87c-24cb3ddc1ff3 62185-0020 HUMAN OTC DRUG WLP40 Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Cerebrum Suis, Hepar Suis, Kidney Suis, Methylcobalamin, Pancreas Suis, Stomach (Suis), AACG-A, AACG-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-KETO-DHEA (Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (Suis), Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20160413 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; SUS SCROFA CEREBRUM; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62185-0021_cc94e57c-d998-4cf4-8432-ef7098b752af 62185-0021 HUMAN OTC DRUG Professional Weight Maintenance Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Gambogia, Graphites, Nux Vomica, Phytolacca Decandra, 3-Acetyl-7-Oxo-Dehydroepiandrosterone, Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (Suis), Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20160422 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; GAMBOGE; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62185-0022_0d5f5029-a7af-4d3f-8e2c-171a0c5c7e0f 62185-0022 HUMAN OTC DRUG NS Support Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Cuprum Aceticum, Nadidum, Natrum Oxalaceticum, Nicotinamidum, Picricum Acidum, Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, alpha Lipoicum Acidum, Ammonium Muriaticum, Cartilago Suis, Discus Intervertebralis (Suis), Silicea, Argentum Metallicum, Calcarea Phosphorica, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Gnaphalium Polycephalum LIQUID ORAL 20160422 20210712 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; CUPRIC ACETATE; NADIDE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PICRIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; .ALPHA.-LIPOIC ACID; AMMONIUM CHLORIDE; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SUS SCROFA BONE MARROW; MERCURIC OXIDE; PANTOTHENIC ACID; SULFUR; ENTEROBACTER CLOACAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII; PROTEUS VULGARIS 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 28; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0023_c4b95880-789d-423a-9331-a14a97af7288 62185-0023 HUMAN OTC DRUG Intercellular Detox Ceanothus Americanus, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Hydrastis Canadensis, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (Vulgaris), Bile Duct (Suis), Colon (Suis), Duodenum (Suis), Esophagus (Suis), Eye (Suis), Gallbladder (Suis), Ileum (Suis), Intestine (Suis), Ipecacuanha, Jejunum (Suis), Kali Bichromicum, Lung (Suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (Suis), Pancreas Suis, Phosphorus, Rectal Mucosa (Suis), Stomach (Suis) LIQUID ORAL 20160706 20211205 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC CEANOTHUS AMERICANUS LEAF; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; MARSDENIA CONDURANGO BARK; GOLDENSEAL; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PULSATILLA VULGARIS; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTUM; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; ATROPA BELLADONNA; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0024_024762fb-dfdb-484e-bd9c-23a7cee0cbef 62185-0024 HUMAN OTC DRUG Sleep Tight Adenosinum Triphosphoricum Dinatrum, Pantothenic Acid, Pineal Gland (Suis), Sarcolacticum Acidum, Ubidecarenonum, L-Tryptophan, Melatonin, Pyrrole, Arsenicum Album, Avena Sativa, Chamomilla, Coffea Cruda, Mercurius Corrosivus, Passiflora Incarnata, Silicea, Zincum Valerianicum, Dysentery Bacillus, Gaertner Bacillus (Bach) LIQUID ORAL 20170214 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC ADENOSINE TRIPHOSPHATE DISODIUM; PANTOTHENIC ACID; SUS SCROFA PINEAL GLAND; LACTIC ACID, L-; UBIDECARENONE; TRYPTOPHAN; MELATONIN; PYRROLE; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; MATRICARIA CHAMOMILLA; ARABICA COFFEE BEAN; MERCURIC CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE; ZINC VALERATE DIHYDRATE; SHIGELLA DYSENTERIAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0025_f59f243e-43ba-4cbd-9957-f7458bdb7a6d 62185-0025 HUMAN OTC DRUG Brain Support Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, Gaba (Gamma Aminobutyric Acid), Norepinephrine, Octopamine, Serotonin (Hydrochloride), Taurine, Adenosinum Cyclophosphoricum, Cerebrum (Suis), Diencephalon (Suis), Pineal Gland (Suis), Thalamus Opticus (Suis) LIQUID ORAL 20161123 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC ACETYLCHOLINE CHLORIDE; EPINEPHRINE; DOPAMINE HYDROCHLORIDE; .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; OCTOPAMINE; SEROTONIN HYDROCHLORIDE; TAURINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62185-0027_36bf0dea-1599-4636-b30e-18cdfd0c97a5 62185-0027 HUMAN OTC DRUG Metdetox Allium Sativum, Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Ascorbic Acid, Cysteinum, L-Methionine, Thyroidinum (Suis), Calcarea Phosphorica, Chromium Metallicum, Cobaltum Metallicum, Cuprum Metallicum, Ferrum Metallicum, Iodium, Iridium Metallicum, Kali Carbonicum, Lithium Carbonicum, Magnesium Metallicum, Manganum Metallicum, Molybdenum, Natrum Muriaticum, Phosphorus, Selenium Metallicum, Strontium Carbonicum, Sulphur LIQUID ORAL 20161129 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC GARLIC; BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; ASCORBIC ACID; CYSTEINE; METHIONINE; SUS SCROFA THYROID; TRIBASIC CALCIUM PHOSPHATE; CHROMIUM; COBALT; COPPER; IRON; IODINE; IRIDIUM; POTASSIUM CARBONATE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MOLYBDENUM; SODIUM CHLORIDE; PHOSPHORUS; SELENIUM; STRONTIUM CARBONATE; SULFUR; VANADIUM; ZINC; PHENOL; FORMALDEHYDE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; BORON; ALUMINUM; ANTIMONY; SILVER; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BROMINE; CADMIUM; CERIUM; CESIUM; DYSPROSIUM; ERBIUM; EUROPIUM; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; TIN; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; YTTERBIUM OXIDE; ARSENIC ACID; MERCURIUS SOLUBILIS; LEAD; LANTHANUM; NIOBIUM; TANTALUM 3; 3; 3; 3; 3; 3; 3; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 1000; 1000; 1000; 14; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0028_2c28cb38-6ee2-401d-b96a-d3af3ec2c283 62185-0028 HUMAN OTC DRUG NS Support Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Cuprum Aceticum, Nadidum, Natrum Oxalaceticum, Nicotinamidum, Picricum Acidum, Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Alpha-Lipoicum Acidum, Ammonium Muriaticum, Cartilago Suis, Discus Intervertebralis Suis, Silicea, Argentum Metallicum, Calcarea Phosphorica, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Gnaphalium Polycephalum LIQUID ORAL 20161122 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; LEDUM PALUSTRE TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; CUPRIC ACETATE; NADIDE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PICRIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; THIOCTIC ACID; AMMONIUM CHLORIDE; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SUS SCROFA BONE MARROW; MERCURIC OXIDE; PANTOTHENIC ACID; SULFUR; ENTEROBACTER CLOACAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII; PROTEUS VULGARIS 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 28; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0029_fc608876-5ba6-49e7-bbd6-e937b118c7dc 62185-0029 HUMAN OTC DRUG D3 Organ Support Conium Maculatum, Dulcamara, Echinacea (Angustifolia), Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid, Coccus Cacti, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Pulsatilla (Vulgaris), Sarcolacticum Acidum, Lymph Node (Suis), Sulphur, Glandula Suprarenalis Suis, Phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (Suis), Spleen (Suis), Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Glyphosate, Funiculus Umbilicalis Suis, Tonsil (Suis) LIQUID ORAL 20161123 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA ANGUSTIFOLIA; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; ANEMONE PULSATILLA; LACTIC ACID, L-; SUS SCROFA LYMPH; SULFUR; SUS SCROFA ADRENAL GLAND; PHENYLALANINE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA SPLEEN; CORTISONE ACETATE; MERCURIUS SOLUBILIS; BARIUM CARBONATE; GLYPHOSATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA TONSIL; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; LIOTHYRONINE; SUS SCROFA BONE MARROW; BISPHENOL A; BROMINE; CHLORINE; HYDROFLUORIC ACID; IODINE; ESCHERICHIA COLI 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 10; 10; 10; 10; 10; 13; 13; 28; 1000; 6; 6; 9; 10; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0030_a8961eb0-efa6-4b2d-a891-591b27034d0f 62185-0030 HUMAN OTC DRUG Intercellular Detox Ceanothus Americanus, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Hydrastis Canadensis, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (Vulgaris), Bile Duct (Suis), Colon (Suis), Duodenum (Suis), Esophagus (Suis), Eye (Suis), Gallbladder (Suis), Ileum (Suis), Intestine (Suis), Ipecacuanha, Jejunum (Suis), Kali Bichromicum, Lung (Suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (Suis), Pancreas Suis, Phosphorus, Rectal Mucosa (Suis), Stomach (Suis) LIQUID ORAL 20170306 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC CEANOTHUS AMERICANUS LEAF; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; MARSDENIA CONDURANGO BARK; GOLDENSEAL; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; PULSATILLA VULGARIS; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; ATROPA BELLADONNA; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0031_0ccf9e4e-6dc7-4467-a723-1c3689b781ea 62185-0031 HUMAN OTC DRUG D1 Organ Support Carduus Marianus, Chelidonium Majus, Cinchona Officinalis, Lycopodium Clavatum, Taraxacum Officinale, Veratrum Album, Avena Sativa, Cynara Scolymus, Methylcobalamin, Menadione, Alpha Lipoicum Acidum, Hepar Suis, Colon (Suis), Duodenum (Suis), Gallbladder (Suis), Intestine (Suis), Lymph Node (Suis), Pancreas Suis, Thymus (Suis), Alpha Ketoglutaricum Acidum, Cholesterinum, Formicum Acidum, Glyoxal Trimer Dihydrate, Histaminum Hydrochloricum, Malic Acid, Natrum Oxalaceticum, Sulphur, Calcarea Carbonica LIQUID ORAL 20170308 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC MILK THISTLE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT; AVENA SATIVA FLOWERING TOP; OAT STRAW; CYNARA SCOLYMUS LEAF; METHYLCOBALAMIN; MENADIONE; .ALPHA.-LIPOIC ACID; PORK LIVER; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; PORK INTESTINE; SUS SCROFA LYMPH; SUS SCROFA PANCREAS; SUS SCROFA THYMUS; .ALPHA.-KETOGLUTARIC ACID; CHOLESTEROL; FORMIC ACID; GLYOXAL TRIMER DIHYDRATE; HISTAMINE DIHYDROCHLORIDE; MALIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; OROTIC ACID MONOHYDRATE; PROTEUS MORGANII; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 3; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 13; 28; 7; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62185-0032_e9254860-eb97-459d-b659-c59fcbd22187 62185-0032 HUMAN OTC DRUG D2 Organ Support Solidago Virgaurea, Baptisia Tinctoria, Berberis Vulgaris, Equisetum Hyemale, Argentum Nitricum, Cantharis, Capsicum Annuum, Cuprum Sulphuricum, Orthosiphon Stamineus, Pareira Brava, Sarsaparilla (Smilax Regelii), Terebinthina, Apis Venenum Purum, Barosma (Betulina), Mercurius Corrosivus, Pyelon (Suis), Ureter (Suis), Urethra (Suis), Urinary Bladder (Suis), Glyoxal Trimer Dihydrate, Hepar Sulphuris Calcareum, Natrum Pyruvicum, Quercetin, Colibacillinum Cum Natrum Muriaticum, Dysentery Bacillus LIQUID ORAL 20170308 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC SOLIDAGO VIRGAUREA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; SILVER NITRATE; LYTTA VESICATORIA; CAPSICUM; CUPRIC SULFATE; CLERODENDRANTHUS SPICATUS LEAF; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; TURPENTINE OIL; APIS MELLIFERA VENOM; AGATHOSMA BETULINA LEAF; MERCURIC CHLORIDE; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; GLYOXAL TRIMER DIHYDRATE; CALCIUM SULFIDE; SODIUM PYRUVATE; QUERCETIN; ESCHERICHIA COLI; SHIGELLA DYSENTERIAE 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62185-0033_501f1332-7c52-4eda-b29e-d6ffe80a1c40 62185-0033 HUMAN OTC DRUG Chemdetox Berberis Vulgaris, Glycyrrhiza Glabra, Lappa Major, Phytolacca Decandra, Stillingia Sylvatica, Trifolium Pratense, Glandula Suprarenalis Suis, Hepar Suis, Lymph Node (Suis), Thyroidinum (Suis), Belladonna, Iridium Metallicum, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Phosphoricum Acidum, Selenium Metallicum, Salicylicum Acidum, Adrenocorticotrophin, Cortisone Aceticum, Eugenol, Stearyl Alcohol, Xylitol, Folliculinum, Benzoicum Acidum, Chlorinum, Potassium Sorbate, Sorbitol, Resorcinum LIQUID ORAL 20170308 UNAPPROVED HOMEOPATHIC Dr. Donna Restivo DC BERBERIS VULGARIS ROOT BARK; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA LYMPH; SUS SCROFA THYROID; ATROPA BELLADONNA; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; SELENIUM; SALICYLIC ACID; CORTICOTROPIN; CORTISONE ACETATE; EUGENOL; STEARYL ALCOHOL; XYLITOL; ESTRONE; BENZOIC ACID; CHLORINE; POTASSIUM SORBATE; SORBITOL; RESORCINOL; BENZYL ALCOHOL; LACTIC ACID, DL-; ISOPROPYL PALMITATE; BORIC ACID; ACETIC ACID; PHENYL BUTYRATE; PETROLATUM; LEAD 3; 3; 3; 3; 3; 3; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62187-0001_584a3278-f922-460c-986b-6bcdea45e4e7 62187-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950921 UNAPPROVED MEDICAL GAS Deborah Stubblefield dba Respiratory Services OXYGEN 99 L/100L E 20171231 62191-004_63e98caf-8864-4efd-8b07-bb7279981d63 62191-004 HUMAN OTC DRUG Oi Lin Natural Sunscreen SPF 30 SUNSCREEN, TITANIUM DIOXIDE EMULSION TOPICAL 19900801 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. TITANIUM DIOXIDE .66 g/g E 20171231 62191-007_98c5593a-c1f3-44bc-af6e-0f21fbbea81d 62191-007 HUMAN OTC DRUG Protective Foundation Sunscreen SPF 15 Sunscreen, AVOBENZONE, OCTINOXATE EMULSION TOPICAL 20020301 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. AVOBENZONE; OCTINOXATE .02; .06 g/g; g/g E 20171231 62191-010_62fdd9f8-ed38-4140-8185-93d23928a19d 62191-010 HUMAN OTC DRUG OI LIN DEEP MOISTURE SUNSCREEN SPF 25 TINTED SUNSCREEN, TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20090127 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. TITANIUM DIOXIDE; ZINC OXIDE 94; 39 mg/g; mg/g E 20171231 62191-012_86cf55d3-97bf-4f5d-ae4d-6ab178a9863d 62191-012 HUMAN OTC DRUG OI LIN SUNMILK SUNSCREEN SPF 25 SUNSCREEN, TITANIUM DIOXIDE EMULSION TOPICAL 20090423 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. TITANIUM DIOXIDE 85 mg/g E 20171231 62191-021_862eb44e-091e-4e76-8eb7-35d8f30d4b60 62191-021 HUMAN OTC DRUG OI LIN DEEP MOISTURE SUNSCREEN SPF 25 SUNSCREEN, TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20170801 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. TITANIUM DIOXIDE; ZINC OXIDE 94; 39 mg/g; mg/g N 20191231 62191-032_831f51b5-7112-4b3d-8927-36367474ebfc 62191-032 HUMAN OTC DRUG OI LIN DEEP MOISTURE SUNSCREEN SPF 25 Tinted SUNSCREEN, TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20170801 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. TITANIUM DIOXIDE; ZINC OXIDE 94; 39 mg/g; mg/g N 20191231 62191-401_088f3f76-b7e6-4753-a035-1b24a05c7a70 62191-401 HUMAN OTC DRUG Protective Foundation Sunscreen SPF 15 401 Creamy Bisque Sunscreen, AVOBENZONE, OCTINOXATE EMULSION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. AVOBENZONE; OCTINOXATE .02; .06 g/g; g/g N 20181231 62191-402_ab3a7958-6229-49b2-b70d-5d16906a7ec8 62191-402 HUMAN OTC DRUG Protective Foundation Sunscreen SPF 15 402 Fair Ivory Sunscreen, AVOBENZONE, OCTINOXATE EMULSION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. AVOBENZONE; OCTINOXATE .02; .06 g/g; g/g N 20181231 62191-404_0a535e50-7097-4604-a845-fac62cb8776a 62191-404 HUMAN OTC DRUG Protective Foundation Sunscreen SPF 15 404 Light Beige Sunscreen, AVOBENZONE, OCTINOXATE EMULSION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. AVOBENZONE; OCTINOXATE .02; .06 g/g; g/g N 20181231 62191-406_d23ed04e-fd9d-4249-9605-5a4a317d6c63 62191-406 HUMAN OTC DRUG Protective Foundation Sunscreen SPF 15 406 Medium Beige Sunscreen, AVOBENZONE, OCTINOXATE EMULSION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. AVOBENZONE; OCTINOXATE .02; .06 g/g; g/g N 20181231 62191-412_20c29feb-6cbc-48ff-8721-30b28fed73e4 62191-412 HUMAN OTC DRUG Protective Foundation Sunscreen SPF 15 412 Natural Beige Sunscreen, AVOBENZONE, OCTINOXATE EMULSION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. AVOBENZONE; OCTINOXATE .02; .06 g/g; g/g N 20181231 62191-414_3953c0f4-895b-4fac-93dd-87d0b6243968 62191-414 HUMAN OTC DRUG Protective Foundation Sunscreen SPF 15 414 Fair Beige Sunscreen, AVOBENZONE, OCTINOXATE EMULSION TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. AVOBENZONE; OCTINOXATE .02; .06 g/g; g/g N 20181231 62191-500_2a7270c3-2854-470e-a3c8-9e7904463f89 62191-500 HUMAN OTC DRUG OI LIN SUNMILK SUNSCREEN SPF 25 SUNSCREEN, TITANIUM DIOXIDE EMULSION TOPICAL 20170727 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. TITANIUM DIOXIDE 85 mg/g N 20181231 62191-801_dfa20a53-c484-40dd-b3a0-ed893d95949c 62191-801 HUMAN OTC DRUG Oi Lin Natural Emulsion SPF 30 SUNSCREEN, TITANIUM DIOXIDE EMULSION TOPICAL 20171002 OTC MONOGRAPH FINAL part352 Sunrider Manufacturing L.P. TITANIUM DIOXIDE .65 g/g N 20181231 62192-8500_40f108d6-4c4d-4adb-983a-486692eb7dbd 62192-8500 HUMAN OTC DRUG Preboost benzocaine LIQUID TOPICAL 20140218 OTC MONOGRAPH FINAL part348 944 Corp BENZOCAINE 4 g/100mL N 20181231 62195-051_5ea65285-d041-7daf-e053-2991aa0a5c69 62195-051 VACCINE Ixiaro Japanese Encephalitis Vaccine, Inactivated, Adsorbed INJECTION, SUSPENSION INTRAMUSCULAR 20090330 BLA BLA125280 Vetter Pharma Fertigung GmbH & Co. KG JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) 6 ug/.5mL Inactivated Japanese Encephalitis Virus Vaccine [EPC],Actively Acquired Immunity [PE],Japanese Encephalitis Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] N 20181231 62206-0314_4be51f0b-b292-381b-e054-00144ff88e88 62206-0314 HUMAN OTC DRUG Badger Damascus Rose Broad Spectrum SPF 25 Face Sunscreen - Sheer Tint ZINC OXIDE LOTION TOPICAL 20170329 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 14 g/100mL N 20181231 62206-0315_4be3b354-ee7d-2cfe-e054-00144ff8d46c 62206-0315 HUMAN OTC DRUG Badger Damascus Rose Broad Spectrum SPF 25 Face Sunscreen ZINC OXIDE LOTION TOPICAL 20170329 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 14 g/100mL N 20181231 62206-0336_4bbaac53-82ae-6e94-e054-00144ff8d46c 62206-0336 HUMAN OTC DRUG Badger Unscented Broad Spectrum SPF 25 Zinc Oxide Sunscreen ZINC OXIDE LOTION TOPICAL 20170327 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 14 g/100mL N 20181231 62206-2850_244ac5d9-0017-482a-e054-00144ff88e88 62206-2850 HUMAN OTC DRUG Badger Diaper ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 10 g/100mL N 20181231 62206-3360_54232d88-ed92-04da-e054-00144ff8d46c 62206-3360 HUMAN OTC DRUG Badger Essential Baby Set Zinc oxide KIT 20170621 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. N 20181231 62206-4603_244b582b-34dc-382e-e054-00144ff8d46c 62206-4603 HUMAN OTC DRUG Badger Unscented SPF 15 Sunscreen ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 10 g/100mL N 20181231 62206-4654_f4818c01-4f27-4330-ae09-c6982b930da3 62206-4654 HUMAN OTC DRUG Badger SPF 15 Sunscreen Lip Balm ZINC OXIDE STICK TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 8 g/100g E 20171231 62206-4703_244bba95-5dcc-7238-e054-00144ff88e88 62206-4703 HUMAN OTC DRUG Badger Lavender SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 18.75 g/100mL N 20181231 62206-4720_4921fd88-9232-40c0-af5a-e6a6adb28601 62206-4720 HUMAN OTC DRUG Badger SPF 35 All Season Face ZINC OXIDE STICK TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 22.5 g/100g E 20171231 62206-4721_32c66125-ad9d-450b-8e1a-a77e50c8e99b 62206-4721 HUMAN OTC DRUG Badger SPF 35 Kids All Season ZINC OXIDE STICK TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 22.5 g/100g E 20171231 62206-4730_243a3df1-379f-4ef3-e054-00144ff8d46c 62206-4730 HUMAN OTC DRUG Badger SPF 34 Anti-Bug Sunscreen ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 20 g/100mL N 20181231 62206-4740_244bba95-5de5-7238-e054-00144ff88e88 62206-4740 HUMAN OTC DRUG Badger Unscented SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 18.75 g/100mL N 20181231 62206-4741_2439f36f-57f6-3f3f-e054-00144ff88e88 62206-4741 HUMAN OTC DRUG Badger Tinted Unscented SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 18.75 g/100mL N 20181231 62206-4750_244b582b-3506-382e-e054-00144ff8d46c 62206-4750 HUMAN OTC DRUG Badger Baby SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 18.75 g/100mL N 20181231 62206-4760_243a3df1-378c-4ef3-e054-00144ff8d46c 62206-4760 HUMAN OTC DRUG Badger Sport SPF 35 Sunscreen ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 22.5 g/100mL N 20181231 62206-4780_244b582b-3526-382e-e054-00144ff8d46c 62206-4780 HUMAN OTC DRUG Badger Kids SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 18.75 g/100mL N 20181231 62206-4901_abebed97-8a67-4cad-8abb-2d9411f7515e 62206-4901 HUMAN OTC DRUG Badger Damascus Rose Broad Spectrum SPF 20 Face Sunscreen ZINC OXIDE LOTION TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 12 g/100mL E 20171231 62206-4902_5afff6a9-82fa-4ec5-8604-4b9ec7f5565e 62206-4902 HUMAN OTC DRUG Badger Damascus Rose Broad Spectrum SPF 20 Face Sunscreen - Sheer Tint ZINC OXIDE LOTION TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 12 g/100mL E 20171231 62206-4904_2e8628f5-3c76-0c83-e054-00144ff88e88 62206-4904 HUMAN OTC DRUG Badger Damascus Rose Broad Spectrum SPF 25 Face Sunscreen ZINC OXIDE LOTION TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 W.S. Badger Company, Inc. ZINC OXIDE 14 g/100mL N 20181231 62207-357_3ed4ced8-f47a-20f4-e054-00144ff8d46c 62207-357 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20161117 ANDA ANDA202312 Granules India Limited IBUPROFEN 200 mg/1 N 20181231 62207-358_3ed4ced8-f47a-20f4-e054-00144ff8d46c 62207-358 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20161117 ANDA ANDA202312 Granules India Limited IBUPROFEN 200 mg/1 N 20181231 62207-365_8398875d-851c-482d-a471-13c954cd6d29 62207-365 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110101 ANDA ANDA079174 Granules India Limited IBUPROFEN 200 mg/1 N 20181231 62207-366_8398875d-851c-482d-a471-13c954cd6d29 62207-366 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110101 ANDA ANDA079174 Granules India Limited IBUPROFEN 200 mg/1 N 20181231 62207-750_fea7ea82-2d26-426c-a529-23861bc638ec 62207-750 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20110930 ANDA ANDA091353 Granules India Limited NAPROXEN SODIUM 220 mg/1 N 20181231 62207-753_fea7ea82-2d26-426c-a529-23861bc638ec 62207-753 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20110930 ANDA ANDA091353 Granules India Limited NAPROXEN SODIUM 220 mg/1 N 20181231 62207-912_50beec79-a713-0d98-e054-00144ff88e88 62207-912 HUMAN OTC DRUG Acetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride Acetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20170707 OTC MONOGRAPH FINAL part341 Granules India Limited PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE 5; 325; 10 mg/1; mg/1; mg/1 N 20181231 62207-913_50c3a7ee-04d5-363b-e054-00144ff88e88 62207-913 HUMAN OTC DRUG Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate Phenylephrine Hydrochloride Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20170707 OTC MONOGRAPH FINAL part341 Granules India Limited DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 6.25; 10; 325; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 62209-9266_843ead7f-6cf7-47da-8d8b-eba5d035bc37 62209-9266 HUMAN OTC DRUG Huo Pao Tieh Ta Feng Shin Kao L-Menthol, Camphor PLASTER TOPICAL 20130906 OTC MONOGRAPH NOT FINAL part348 Dah Wei Biochemical Pharmaceutic International Ltd. LEVOMENTHOL; CAMPHOR (SYNTHETIC) 200; 40 mg/5g; mg/5g E 20171231 62211-127_d3bc1582-be9b-4a30-ba01-587132319b44 62211-127 HUMAN OTC DRUG D-Cal SoyCal calcium carbonate and soy isoflavones and vitamin D3 TABLET ORAL 20100122 OTC MONOGRAPH FINAL part331 A&Z Pharmaceutical, Inc. CALCIUM CARBONATE; SOY ISOFLAVONES; CHOLECALCIFEROL 28.32; 1; 480 g/1; g/1; ug/1 E 20171231 62211-166_c4c180cf-1acc-4a8e-b296-efdcb46c51f7 62211-166 HUMAN OTC DRUG D-CAL calcium carbonate TABLET, CHEWABLE ORAL 19970917 OTC MONOGRAPH FINAL part331 A&Z Pharmaceutical Inc. CALCIUM CARBONATE 750 mg/1 N 20181231 62211-196_afc32948-04d2-4f9b-8efe-ee41013aa373 62211-196 HUMAN OTC DRUG D-Cal Kids Calcium Carbonate TABLET, CHEWABLE ORAL 19970917 OTC MONOGRAPH FINAL part331 A&Z Pharmaceutical, Inc. CALCIUM CARBONATE 750 mg/1 N 20181231 62211-239_240d2236-2ea6-4a19-ac94-a340cb61b2df 62211-239 HUMAN OTC DRUG D-Cal Kids Calcium Carbonate GRANULE ORAL 20080104 OTC MONOGRAPH FINAL part331 A&Z Pharmaceutical, Inc. CALCIUM CARBONATE 750 mg/g N 20181231 62212-252_ab880999-df72-4620-b1b1-31ddf1c7bba2 62212-252 HUMAN OTC DRUG Menthol Amish Origins Medicated CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Amish Origins LLC MENTHOL 8 g/100g N 20181231 62212-350_9aecb197-0617-4043-83e3-00e0abae5b0b 62212-350 HUMAN OTC DRUG Amish Origins SPF 15 Lip Balm Octinoxate, Octocrylene, Oxybenzone STICK TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part352 Amish Origins OCTINOXATE; OXYBENZONE; OCTOCRYLENE 7.5; 4; 2 mg/g; mg/g; mg/g N 20181231 62217-001_649648c7-d296-be91-e053-2a91aa0aede5 62217-001 HUMAN OTC DRUG Fruit of the Earth, Inc. Luv That Sun SPF 30 Natural Mineral Sunscreen titanium dioxide, zinc oxide LOTION TOPICAL 20180206 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. ZINC OXIDE; TITANIUM DIOXIDE 40.4625; 31.16 mg/mL; mg/mL N 20191231 62217-003_6491b1c3-d8f2-a9eb-e053-2a91aa0a11fe 62217-003 HUMAN OTC DRUG Fruit of the Earth, Inc. Luv That Sun Kids SPF 50 Natural Sunscreen avobenzone, homosalate, octocrylene LOTION TOPICAL 20180206 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. AVOBENZONE; OCTOCRYLENE; HOMOSALATE 30; 60; 100 mg/mL; mg/mL; mg/mL N 20191231 62217-004_4f92f33c-64f1-0664-e054-00144ff88e88 62217-004 HUMAN OTC DRUG Fruit of the Earth Block Up SPF 50 Full Spectrum Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTINOXATE; OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 75; 15; 50; 90; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-005_503b3b9f-1a2f-530b-e054-00144ff88e88 62217-005 HUMAN OTC DRUG Fruit of the Earth Block Up Kids SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170330 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 20; 90; 75; 50; 50; 15 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-006_57d2549e-faf4-1791-e053-2a91aa0a7f63 62217-006 HUMAN OTC DRUG Fruit of the Earth, Inc. Ultra SPF 50 Moisturizing Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170512 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 90; 75; 50; 20; 50; 15 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-007_4bba3a8d-323d-5f45-e054-00144ff8d46c 62217-007 HUMAN OTC DRUG Fruit of the Earth Cool Blue Aloe Vera Cooling Menthol, Allantoin GEL TOPICAL 20170327 OTC MONOGRAPH NOT FINAL part348 Fruit of the Earth, Inc. MENTHOL; ALLANTOIN 5; 2 mg/g; mg/g N 20181231 62217-008_57d2549e-fb04-1791-e053-2a91aa0a7f63 62217-008 HUMAN OTC DRUG Fruit of the Earth SPF 50 Moisturizing Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170516 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTINOXATE; OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 75; 15; 50; 90; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-009_57d213e3-fdcd-70b1-e053-2991aa0a2e9b 62217-009 HUMAN OTC DRUG Fruit of the Earth Block Up Sport SPF 30 Sunscreen Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170516 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; OXYBENZONE 75; 15; 50; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-011_57d2549e-fb13-1791-e053-2a91aa0a7f63 62217-011 HUMAN OTC DRUG Fruit of the Earth SPF 4 Moisturizing Tanning Sunscreen Octinoxate, Oxybenzone LOTION TOPICAL 20170516 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTINOXATE; OXYBENZONE 20; 5 mg/mL; mg/mL N 20181231 62217-012_4fa6b17b-88d9-0ed2-e054-00144ff8d46c 62217-012 HUMAN OTC DRUG Fruit of the Earth Sport SPF 50 Sunscreen Continuous Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170516 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 50; 30; 100; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-013_503ab067-0fe8-3d2c-e054-00144ff88e88 62217-013 HUMAN OTC DRUG Fruit of the Earth Block Up Kids SPF 50 Moisturizing Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170523 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 20; 90; 75; 50; 50; 15 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-014_50466211-e6ce-351f-e054-00144ff8d46c 62217-014 HUMAN OTC DRUG Fruit of the Earth Block Up Sport SPF 50 Continuous Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170524 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 50; 30; 100; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-015_50478011-2721-53c0-e054-00144ff8d46c 62217-015 HUMAN OTC DRUG Fruit of the Earth Block Up Sport SPF 30 Continuous Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170524 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 50; 30; 100; 20; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-016_504a78ca-42d8-2877-e054-00144ff88e88 62217-016 HUMAN OTC DRUG Fruit of the Earth Block Up Kids SPF 50 Continuous Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170524 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 50; 30; 100; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-017_57d2549e-fb2f-1791-e053-2a91aa0a7f63 62217-017 HUMAN OTC DRUG Fruit of the Earth Block Up Sport SPF 50 Moisturizing Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170524 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; OXYBENZONE 90; 75; 15; 50; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-018_57d2549e-fb3f-1791-e053-2a91aa0a7f63 62217-018 HUMAN OTC DRUG Fruit of the Earth Block Up Sport SPF 50 No Mess Sun Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20170525 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OXYBENZONE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE 30; 100; 150; 30; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 62217-019_505ace8b-823b-098a-e054-00144ff88e88 62217-019 HUMAN OTC DRUG Fruit of the Earth Block Up SPF 30 General Protection Sunscreen Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170525 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; OXYBENZONE 75; 15; 50; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-021_50ff3ed1-9a56-2b86-e054-00144ff88e88 62217-021 HUMAN OTC DRUG Fruit of the Earth Block Up SPF 30 Sunscreen Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170602 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OXYBENZONE; OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 50; 75; 15; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-024_57d2549e-fb4e-1791-e053-2a91aa0a7f63 62217-024 HUMAN OTC DRUG Fruit of the Earth Block Up Sport SPF 50 Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170602 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTINOXATE; OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 75; 15; 50; 90; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-025_5165a7df-9ecc-2892-e054-00144ff88e88 62217-025 HUMAN OTC DRUG Fruit of the Earth Block Up SPF 4 Dark Tanning Octinoxate, Oxybenzone LOTION TOPICAL 20170607 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTINOXATE; OXYBENZONE 20; 5 mg/mL; mg/mL N 20181231 62217-026_5178bc1a-0f12-1e05-e054-00144ff8d46c 62217-026 HUMAN OTC DRUG Fruit of the Earth Block Up Lite Kids SPF 50 Continuous Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone AEROSOL, SPRAY TOPICAL 20170608 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTISALATE; AVOBENZONE; HOMOSALATE; OXYBENZONE 50; 30; 150; 60 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-027_5189e45f-6931-1e01-e054-00144ff88e88 62217-027 HUMAN OTC DRUG Fruit of the Earth Block Up Lite Broad Spectrum SPF 30 Continuous Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone AEROSOL, SPRAY TOPICAL 20170609 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTISALATE; AVOBENZONE; HOMOSALATE; OXYBENZONE 50; 20; 150; 40 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-028_518936b7-d39a-628c-e054-00144ff8d46c 62217-028 HUMAN OTC DRUG Fruit of the Earth Block Up Lite Broad Spectrum SPF 15 Continuous Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone AEROSOL, SPRAY TOPICAL 20170609 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTISALATE; AVOBENZONE; HOMOSALATE; OXYBENZONE 50; 20; 100; 30 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-029_51898e43-6d05-13a8-e054-00144ff88e88 62217-029 HUMAN OTC DRUG Fruit of the Earth Block Up Dry Sport SPF 50 Continuous Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone AEROSOL, SPRAY TOPICAL 20170609 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTISALATE; AVOBENZONE; HOMOSALATE; OXYBENZONE 50; 30; 150; 60 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-050_4b42f29c-0d95-649a-e054-00144ff8d46c 62217-050 HUMAN OTC DRUG Fruit of the Earth Block Up SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170321 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTINOXATE; OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 75; 15; 50; 90; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-152_e7f02de2-e352-45ee-9136-5b21952326d6 62217-152 HUMAN OTC DRUG Presidents Choice Octinoxate, Homosalate, Oxybenzone, Avobenzone LOTION TOPICAL 20050330 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTINOXATE; HOMOSALATE; OXYBENZONE; AVOBENZONE 7.5; 5; 4; 2 g/100g; g/100g; g/100g; g/100g E 20171231 62217-174_0e5ef812-fad0-5654-e054-00144ff88e88 62217-174 HUMAN OTC DRUG Fruit of the Earth Block Up Broad Spectrum Baby SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20140826 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 90; 75; 50; 15; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-186_0e5f5174-0a05-1553-e054-00144ff8d46c 62217-186 HUMAN OTC DRUG Fruit of the Earth Block Up Broad Spectrum Sport SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20150205 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 90; 75; 50; 15; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-200_60a601b3-8ab7-7a45-e053-2a91aa0a2e0b 62217-200 HUMAN OTC DRUG Fruit of the Earth Aloe Vera Cool Blue Lidocaine Hydrochloride GEL TOPICAL 20140910 OTC MONOGRAPH NOT FINAL part348 Fruit of the Earth, Inc. LIDOCAINE 10 mg/g N 20181231 62217-201_8c217e0d-1969-4b2a-a0ad-07c71c951c9a 62217-201 HUMAN OTC DRUG Fruit of the Earth Cool Blue Aloe Mist Continuous Lidocaine Hydrochloride SPRAY TOPICAL 20140912 OTC MONOGRAPH NOT FINAL part348 Fruit of the Earth, Inc. LIDOCAINE 10 mg/mL N 20181231 62217-350_4b432367-66ec-5dba-e054-00144ff88e88 62217-350 HUMAN OTC DRUG Fruit of the Earth Sport SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170321 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTINOXATE; OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 75; 15; 50; 90; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62217-827_4f545d0f-0d20-3768-e054-00144ff88e88 62217-827 HUMAN OTC DRUG Fruit of the Earth, Inc. Luv That Sun SPF 30 Continuous Avobenzone, Homosalate, Octisalate, Octocrylene AEROSOL, SPRAY TOPICAL 20170512 OTC MONOGRAPH NOT FINAL part352 Fruit of the Earth, Inc. OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE 50; 20; 30; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62221-935_269c3e27-875a-40ab-87d6-bbd33012f25e 62221-935 HUMAN OTC DRUG Sonacaine Topical Anesthetic With Menthol LIDOCAINE GEL TOPICAL 20120502 OTC MONOGRAPH FINAL part348 Filltech USA, LLC LIDOCAINE 4 g/100g N 20181231 62223-001_4c98910a-e0ae-4bae-a8f5-ba385ce85c4b 62223-001 HUMAN OTC DRUG Preference Hand Sanitizer Alcohol SPRAY TOPICAL 20140614 OTC MONOGRAPH NOT FINAL part333A Whip Mix Corporation ALCOHOL 340.56 mL/470mL N 20181231 62225-600_2d2e4c67-2fa7-4516-ac1c-c51b7719f4fc 62225-600 HUMAN PRESCRIPTION DRUG Omidria phenylephrine and ketorolac INJECTION, SOLUTION, CONCENTRATE INTRAOCULAR 20140613 NDA NDA205388 Omeros Corporation PHENYLEPHRINE; KETOROLAC 10.16; 2.88 mg/mL; mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 62238-008_f8914933-9399-40fc-963f-f2f8e87a5a02 62238-008 HUMAN PRESCRIPTION DRUG Raplixa fibrinogen human and thrombin human POWDER TOPICAL 20150622 BLA BLA125523 ProFibrix BV FIBRINOGEN HUMAN; HUMAN THROMBIN 79; 699 mg/g; [iU]/g Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 62242-010_f90efcb7-86bf-4126-8de3-f4de8e6b3157 62242-010 HUMAN OTC DRUG SUPREME SKINPIA 10 SUN BLOCK Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20140102 OTC MONOGRAPH NOT FINAL part352 EBAIN Corporation Co., Ltd. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 3.5; 1.5; 1.5 mg/50mL; mg/50mL; mg/50mL E 20171231 62242-020_9dcf88b4-206c-4157-9674-9ee58e639748 62242-020 HUMAN OTC DRUG SUPREME SKINPIA 10 BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140102 OTC MONOGRAPH NOT FINAL part352 EBAIN Corporation Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5; .3 mg/50mL; mg/50mL E 20171231 62242-030_d982dc0d-0038-4df8-ba46-6c00dae8ba3f 62242-030 HUMAN OTC DRUG SKINPIA 10 SKIN SHIELD RENEWAL Dimethicone CREAM TOPICAL 20140102 OTC MONOGRAPH FINAL part347 EBAIN Corporation Co., Ltd. DIMETHICONE .5 mg/50mL E 20171231 62248-120_729b3538-9d7f-4e4e-afca-8e904014efad 62248-120 HUMAN OTC DRUG Exfoliating Cleanser Salicylic Acid LOTION TOPICAL 20150522 OTC MONOGRAPH FINAL part333D Clearall LLC SALICYLIC ACID 20 mg/mL E 20171231 62250-103_169a792d-cc9e-490b-866c-cd47faa0fbe9 62250-103 HUMAN PRESCRIPTION DRUG EPINEPHRINE EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140808 NDA NDA205029 Belcher Pharmaceuticals, LLC EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 62250-619_bad81e16-92c0-40a7-af85-fdd0c3a581f7 62250-619 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20120515 ANDA ANDA078355 Belcher Pharmaceuticals,LLC DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 62250-660_a94710c7-413e-4d24-812f-c4ba81b761fb 62250-660 HUMAN PRESCRIPTION DRUG SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION ORAL; RECTAL 20160315 ANDA ANDA205727 Belcher Pharmaceuticals, LLC SODIUM POLYSTYRENE SULFONATE 4.1 meq/g E 20171231 62250-663_e6677830-c87c-4f8d-b3e3-aacc00da9a41 62250-663 HUMAN PRESCRIPTION DRUG Cefixime cefixime POWDER, FOR SUSPENSION ORAL 20170315 ANDA ANDA206938 Belcher Pharmaceuticals,LLC CEFIXIME 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 62250-664_e6677830-c87c-4f8d-b3e3-aacc00da9a41 62250-664 HUMAN PRESCRIPTION DRUG Cefixime cefixime POWDER, FOR SUSPENSION ORAL 20170315 ANDA ANDA206938 Belcher Pharmaceuticals,LLC CEFIXIME 200 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 62250-668_5567570c-0d2c-40e5-8ca3-0c37faf3eba3 62250-668 HUMAN PRESCRIPTION DRUG Cefixime cefixime POWDER, FOR SUSPENSION ORAL 20170315 ANDA ANDA206939 Belcher Pharmaceuticals,LLC CEFIXIME 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 62250-676_dd0da947-e35a-4ba5-b423-77d3a148ac09 62250-676 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20150630 ANDA ANDA077920 Belcher Pharmaceuticals,LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 62250-677_9c49ca31-b059-4fa4-a4aa-33bb0f918f43 62250-677 HUMAN PRESCRIPTION DRUG Mefenamic Acid Mefenamic Acid CAPSULE ORAL 20150625 ANDA ANDA091608 Belcher Pharmaceuticals,LLC MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 62250-691_e2def58f-218d-4de9-bb88-c03cec0aef0d 62250-691 HUMAN PRESCRIPTION DRUG FENOPROFEN FENOPROFEN CALCIUM CAPSULE ORAL 20170419 NDA NDA017604 Belcher Pharmaceuticals,LLC FENOPROFEN CALCIUM 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 62250-801_78fed700-ee01-4f66-a8e2-46708797d525 62250-801 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110615 ANDA ANDA062713 Belcher Pharmaceuticals, LLC CEPHALEXIN 250 mg/1 E 20171231 62250-802_78fed700-ee01-4f66-a8e2-46708797d525 62250-802 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110615 ANDA ANDA062713 Belcher Pharmaceuticals, LLC CEPHALEXIN 500 mg/1 E 20171231 62257-012_53e30cc3-4653-427c-9564-a2b89b381a0f 62257-012 HUMAN OTC DRUG 1012 Antimicrobial CHLOROXYLENOL SOAP TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL N 20181231 62257-014_e3f8a26b-2a48-45ee-9557-0cc750634a5d 62257-014 HUMAN OTC DRUG 1014 Foaming Antimicrobial TRICLOSAN SOAP TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. TRICLOSAN .003 mg/mL E 20171231 62257-160_cd68b297-8b56-469c-9f73-075338427fad 62257-160 HUMAN OTC DRUG Lynx Antibacterial CHLOROXYLENOL SOAP TOPICAL 20060714 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL N 20181231 62257-161_5a03b26d-61f7-40e7-a12d-91264b973ad4 62257-161 HUMAN OTC DRUG Lynx Foamy PCMX Antiseptic Hand and Body Wash 6876 CHLOROXYLENOL SOAP TOPICAL 20170207 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL N 20181231 62257-221_aea401ec-46a3-40a8-ad1a-b44ae050a640 62257-221 HUMAN OTC DRUG Hand-Aid ALCOHOL GEL TOPICAL 20001218 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL N 20181231 62257-265_793d0ac6-6740-43be-8333-b013387538a6 62257-265 HUMAN OTC DRUG Aero Care Handy Quat Antiseptic Handwash BENZALKONIUM CHLORIDE SOAP TOPICAL 20170217 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. BENZALKONIUM CHLORIDE 25 mg/mL N 20181231 62257-363_febeb5b5-e67c-4775-b501-5476ea0d2d47 62257-363 HUMAN OTC DRUG Cleanse CHLOROXYLENOL SOAP TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL N 20181231 62257-364_674d7418-dbd9-4262-97de-4dd6bc3b82dc 62257-364 HUMAN OTC DRUG Prevens TRICLOSAN SOAP TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. TRICLOSAN .003 mL/mL E 20171231 62257-365_133da4be-b4a0-433f-8b90-de9d6f7b6ec1 62257-365 HUMAN OTC DRUG Sani-Silk ALCOHOL LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL N 20181231 62257-366_068dc902-0e24-4026-8b25-607a1e66113f 62257-366 HUMAN OTC DRUG Jade MENTHOL SOAP TOPICAL 20100801 UNAPPROVED DRUG OTHER ABC Compounding Co., Inc. MENTHOL 4 mg/mL N 20181231 62257-367_9639e347-8a55-427d-b4c0-10d355523de0 62257-367 HUMAN OTC DRUG Coral TRICLOSAN SOAP TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. TRICLOSAN .003 mL/mL E 20171231 62257-369_1fc9deff-6065-4a49-85ee-ffe30e039a09 62257-369 HUMAN OTC DRUG Clean All ALCOHOL LIQUID TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL N 20181231 62257-370_2ae6d037-a1ee-43dc-9838-152696a87d63 62257-370 HUMAN OTC DRUG Clean BENZETHONIUM CHLORIDE LIQUID TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 62257-512_945b7ec7-8cbd-4def-b49a-4da40c868b96 62257-512 HUMAN OTC DRUG Handy Quat BENZALKONIUM CHLORIDE SOAP TOPICAL 19950515 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM CHLORIDE (C12-C14); BENZALKONIUM CHLORIDE 12.5; 12.5 mg/mL; mg/mL E 20171231 62257-544_65af7578-814e-4f47-8da6-666f05ea4fd7 62257-544 HUMAN OTC DRUG Palm CHLOROXYLENOL SOAP TOPICAL 19981221 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL N 20181231 62257-575_c62e150a-15d7-4f8d-b58f-cf7f270f58a4 62257-575 HUMAN OTC DRUG QS Plus BENZETHONIUM CHLORIDE LIQUID TOPICAL 20030630 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 62257-576_c56831b4-2584-4aca-86b4-e1bb034c94f5 62257-576 HUMAN OTC DRUG Foamy Mango TRICLOSAN SOAP TOPICAL 20030703 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. TRICLOSAN .003 mL/mL E 20171231 62257-585_2b2fe544-a9d9-4471-9a9e-61c9f2a642ba 62257-585 HUMAN OTC DRUG Fast ALCOHOL LIQUID TOPICAL 20071220 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. ALCOHOL .7 mL/mL E 20171231 62257-605_ed5ca57e-c210-4833-9369-32f76995404f 62257-605 HUMAN OTC DRUG Alcogel ALCOHOL GEL TOPICAL 20070427 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL N 20181231 62257-606_5a93284c-3db0-438b-8c47-979c3c0d5460 62257-606 HUMAN OTC DRUG Hand-E XL ALCOHOL GEL TOPICAL 20050401 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL N 20181231 62257-607_00451f0a-813b-477b-886c-93746029d5da 62257-607 HUMAN OTC DRUG Hand Sanitizer ALCOHOL GEL TOPICAL 20060714 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL N 20181231 62257-639_7e92a011-2402-4dbf-8021-ea8f77537354 62257-639 HUMAN OTC DRUG Clean All ALCOHOL LIQUID TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .62 mL/mL N 20181231 62257-738_2df3c152-e659-4295-9c7e-7e123ab0070a 62257-738 HUMAN OTC DRUG Sani-Spritz ALCOHOL LIQUID TOPICAL 20091031 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. ALCOHOL .7 mL/mL E 20171231 62257-770_c7b146c0-c19e-4420-81ab-de6a54c0f39c 62257-770 HUMAN OTC DRUG Antibacterial CHLOROXYLENOL SOAP TOPICAL 20140409 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL N 20181231 62257-773_90e3f8eb-e736-4923-b2cd-d884ead724bf 62257-773 HUMAN OTC DRUG MediSoft ALCOHOL AEROSOL, FOAM TOPICAL 20090831 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. ALCOHOL 620 mg/g N 20181231 62257-783_b4c5512f-bfbc-44c6-8944-409eed07be13 62257-783 HUMAN OTC DRUG Hand Sanitizing Wipes ALCOHOL CLOTH TOPICAL 20090409 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. ALCOHOL 620 mg/g N 20181231 62257-785_c6c49637-65eb-45f9-b867-85d048f5da52 62257-785 HUMAN OTC DRUG QS Plus Hand Sanitizing Wipes BENZETHONIUM CHLORIDE CLOTH TOPICAL 20090409 OTC MONOGRAPH NOT FINAL part333 ABC Compounding Co., Inc. BENZETHONIUM CHLORIDE 2 mg/g E 20171231 62257-855_c0c1dbfd-4ec2-4fea-86cd-ae6314501194 62257-855 HUMAN OTC DRUG Fast ALCOHOL LIQUID TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .62 mL/mL N 20181231 62257-856_1723bd32-7ee9-4788-a442-9f6b6b1672df 62257-856 HUMAN OTC DRUG Mousse Vite ALCOHOL LIQUID TOPICAL 20071220 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .62 mL/mL N 20181231 62257-864_d0d8f0e0-2eaf-4e16-9076-8b55f9e0c391 62257-864 HUMAN OTC DRUG Palm CHLOROXYLENOL SOAP TOPICAL 20160819 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL N 20181231 62257-867_075e8995-9b80-43f7-9ac0-3026ff4a24a9 62257-867 HUMAN OTC DRUG Lynx san a foam ALCOHOL LIQUID TOPICAL 20160809 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL N 20181231 62257-868_7005e04d-eae1-418b-bede-0750e102eaf5 62257-868 HUMAN OTC DRUG Lynx medi foam TRICLOSAN SOAP TOPICAL 20160809 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. TRICLOSAN 3 mg/mL N 20181231 62257-869_acb4fea1-203c-408f-b05a-de316291afb1 62257-869 HUMAN OTC DRUG Lynx LX0869 Alcohol Free Hand Sanitizer BENZETHONIUM CHLORIDE SOAP TOPICAL 20170307 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 62257-875_94d6cae4-47f9-4f33-96db-7ca2a7cfac6d 62257-875 HUMAN OTC DRUG Sani Mango Antiseptic Hand and Body Wash CHLOROXYLENOL SOAP TOPICAL 20170104 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL N 20181231 62257-876_ee9b8395-1ab9-4e8a-8952-7a7844243f41 62257-876 HUMAN OTC DRUG Sani Mango Antiseptic Hand and Body Wash CHLOROXYLENOL SOAP TOPICAL 20170104 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL N 20181231 62257-938_1012ed5e-47c5-4b75-9467-8ec4b5a16f28 62257-938 HUMAN OTC DRUG SoftSan ALCOHOL LOTION TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. ALCOHOL .7 mL/mL E 20171231 62257-950_35b8d32f-4ac5-42ce-afc2-28b1ad4a91b1 62257-950 HUMAN OTC DRUG Clear Choice Out of Sight CHLOROXYLENOL SOAP TOPICAL 20140409 OTC MONOGRAPH NOT FINAL part333E ABC Compounding Co., Inc. CHLOROXYLENOL 3 mg/mL N 20181231 62266-3245_9f4729ae-cbc1-44e8-9637-75f2bf9c3a70 62266-3245 HUMAN OTC DRUG Ho Liang Kee Camphor, Menthol OIL TOPICAL 20130223 OTC MONOGRAPH NOT FINAL part348 Changshu Starsea Pharmaceutical Co., Ltd. CAMPHOR OIL; MENTHOL 4.7; 10 g/100g; g/100g E 20171231 62266-3246_4aca4a68-a0cf-4062-e054-00144ff88e88 62266-3246 HUMAN OTC DRUG Tincture Corydalis Myrhh LIQUID TOPICAL 20170303 UNAPPROVED HOMEOPATHIC ChangShu Starsea pharmaceutical Co., Ltd DICENTRA CANADENSIS ROOT; MYRRH 1; 1 [hp_X]/100mL; [hp_X]/100mL N 20181231 62273-001_1db01cdc-bc15-4de0-a720-298b7480639a 62273-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800101 NDA NDA205849 Metro Welding Supply Corporation OXYGEN 995 mL/L N 20181231 62273-002_31976d20-291a-4c46-8520-6eab09bc22e5 62273-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20120301 NDA NDA205850 Metro Welding Supply Corporation NITROGEN 995 mL/L N 20181231 62273-003_48d9086c-a6f3-482a-9c7f-3cb971ef4ca1 62273-003 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20120301 NDA NDA205910 Metro Welding Supply Corporation AIR 1000 mL/L N 20181231 62273-005_6c7f6d80-8028-45df-9096-df298868a41f 62273-005 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20150317 NDA NDA205704 Metro Welding Supply Corporation NITROUS OXIDE 990 mL/L N 20181231 62296-0040_652c968a-06d4-43f1-bd6d-3db85d0a524d 62296-0040 HUMAN OTC DRUG Ulta Sparkling Lemon Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta ALCOHOL 68 mL/100mL N 20181231 62296-0041_d5f636c2-bc63-4516-beb0-5fe239c261fa 62296-0041 HUMAN OTC DRUG Ulta Vanilla Sugar Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta ALCOHOL 68 mL/100mL N 20181231 62296-0042_d7f74976-b23f-46b7-ac1d-9b3193211bae 62296-0042 HUMAN OTC DRUG Ulta Freshwater Mist Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta ALCOHOL 68 mL/100mL N 20181231 62296-0043_60474747-f7e2-436c-adc0-9763f9bc2727 62296-0043 HUMAN OTC DRUG Ulta Mandarin Mint Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta ALCOHOL 68 mL/100mL N 20181231 62296-0044_77d3bb35-6ff3-47a2-a1ec-c6d827142709 62296-0044 HUMAN OTC DRUG Ulta Pomegranate Lime Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta ALCOHOL 68 mL/100mL N 20181231 62296-0045_5b0dd7bd-4679-45c2-ab5d-95ae0433ff8a 62296-0045 HUMAN OTC DRUG Ulta Lavender Woods Anti-Bacterial Hand Sanitizer Alcohol GEL TOPICAL 20110615 OTC MONOGRAPH NOT FINAL part333E Ulta ALCOHOL 68 mL/100mL N 20181231 62296-0118_ae5e2da1-e073-4949-b109-9b6b1eb5cc17 62296-0118 HUMAN OTC DRUG ULTA BEAUTY TINTED MOISTURIZER SPF-30 OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part352 Ulta OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 3.5; 3 g/100mL; g/100mL; g/100mL N 20181231 62296-2273_70d6a95f-a43f-4ce5-9439-aca04e5db586 62296-2273 HUMAN OTC DRUG ULTA Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20150811 OTC MONOGRAPH NOT FINAL part352 Ulta AVOBENZONE; HOMOSALATE; OCTOCRYLENE 1.8; 7; 5 g/100g; g/100g; g/100g N 20181231 62296-2275_6d775d23-b690-4448-bbe2-9604f899e2c8 62296-2275 HUMAN OTC DRUG ULTA SUNSCREEN SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE LOTION TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part352 Ulta AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3; 10; 6 g/100g; g/100g; g/100g N 20181231 62296-3320_9005d653-a307-47ab-925c-a78ddc936ef2 62296-3320 HUMAN OTC DRUG ULTA SUNSCREEN SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20150818 OTC MONOGRAPH NOT FINAL part352 Ulta AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 1.5; 15; 1.2; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62296-3330_48057310-b1b3-467a-9148-2f7a6d052d41 62296-3330 HUMAN OTC DRUG ULTA SUNSCREEN SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20160519 OTC MONOGRAPH NOT FINAL part352 Ulta AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 1; 10; .8; 5; 4 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62296-7031_b909a65b-a935-4cbe-9e06-e0c2882ed020 62296-7031 HUMAN OTC DRUG ULTA TANNING SPF 4 Octinoxate, Padimate O LOTION TOPICAL 20150803 OTC MONOGRAPH NOT FINAL part352 Ulta OCTINOXATE; PADIMATE O 2; 1.4 g/100g; g/100g N 20181231 62296-7778_5e448a1b-c28b-4ff0-9154-614ee50d5e52 62296-7778 HUMAN OTC DRUG SPF 30 Sheer sunscreen face Ulta Avobenzone 2.00% Homosalate 15.00% Octinoxate 7.50% Octisalate 5.00% STICK TOPICAL 20160127 OTC MONOGRAPH NOT FINAL part352 Ulta AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 2; 15; 7.5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 62296-7780_2f756e33-f85a-47d3-b321-615be0ae8055 62296-7780 HUMAN OTC DRUG SPF 30 tropical flavor sunscreen lip balm Ulta Avobenzone 2.00% Octisalate 3.00% Octocrylene 7.00% Oxybenzone 3.00% STICK TOPICAL 20160127 OTC MONOGRAPH NOT FINAL part352 Ulta AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 3; 7; 3 g/100g; g/100g; g/100g; g/100g N 20181231 62296-7866_53a7bdb8-b2f8-4c4e-a7d8-8f0d0ebe6ab3 62296-7866 HUMAN OTC DRUG ULTA SUN DRY TOUCH SPF 55 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20160519 OTC MONOGRAPH NOT FINAL part352 Ulta AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2; 6 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62296-8210_27c55b8b-d117-46d0-819b-5ce0caee046b 62296-8210 HUMAN OTC DRUG ULTA SUNSCREEN SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20160125 OTC MONOGRAPH NOT FINAL part352 Ulta AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 10; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 62296-8292_d45165d4-d9aa-427b-b338-0512db3b2a4e 62296-8292 HUMAN OTC DRUG ULTA FACE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part352 Ulta AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 2; 13; 2; 5; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 62296-8900_b867b4e9-4c23-4226-bebe-8df405063973 62296-8900 HUMAN OTC DRUG ULTA SUN DRY TOUCH SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20160125 OTC MONOGRAPH NOT FINAL part352 Ulta AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 62307-251_4bf4c6ff-ba44-4c81-b6a7-db1bce356f76 62307-251 HUMAN OTC DRUG S4 Sunscreen Stick SPF30 Titanium Dioxide, Zinc Oxide STICK TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 Isis Enterprises LLC DBA: S4 Suncare TITANIUM DIOXIDE; ZINC OXIDE 5.8; 4.51 g/100g; g/100g N 20181231 62309-777_6e8d8fde-2617-4880-9cc1-0f036cb71093 62309-777 HUMAN OTC DRUG Solves - aspirin Cherry Aspirin STRIP ORAL 20140501 OTC MONOGRAPH FINAL part343 Pace Wellness Inc. ASPIRIN 81 mg/1 E 20171231 62309-779_534d0296-aef7-4918-93ea-fbb16d9dd51b 62309-779 HUMAN OTC DRUG Solves - aspirin Cherry Aspirin STRIP ORAL 20140501 OTC MONOGRAPH FINAL part343 Pace Wellness Inc. ASPIRIN 81 mg/1 E 20171231 62332-001_c8a3bcba-9ec7-4d5b-860d-e85dc030c131 62332-001 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 Alembic Pharmaceuticals Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 62332-002_c8a3bcba-9ec7-4d5b-860d-e85dc030c131 62332-002 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 Alembic Pharmaceuticals Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 62332-008_303dd684-a964-4eae-aa45-8a8539c6947e 62332-008 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Alembic Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62332-009_303dd684-a964-4eae-aa45-8a8539c6947e 62332-009 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Alembic Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62332-010_303dd684-a964-4eae-aa45-8a8539c6947e 62332-010 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Alembic Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62332-011_303dd684-a964-4eae-aa45-8a8539c6947e 62332-011 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Alembic Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62332-012_303dd684-a964-4eae-aa45-8a8539c6947e 62332-012 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Alembic Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62332-013_56b23f96-2d7f-417b-ac2e-56816369fe37 62332-013 HUMAN PRESCRIPTION DRUG LITHIUM CARBONATE LITHIUM CARBONATE LITHIUM CARBONATE CAPSULE ORAL 20161227 ANDA ANDA079159 Alembic Pharmaceuticals Inc. LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] N 20181231 62332-014_56b23f96-2d7f-417b-ac2e-56816369fe37 62332-014 HUMAN PRESCRIPTION DRUG LITHIUM CARBONATE LITHIUM CARBONATE LITHIUM CARBONATE CAPSULE ORAL 20161227 ANDA ANDA079159 Alembic Pharmaceuticals Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 62332-015_56b23f96-2d7f-417b-ac2e-56816369fe37 62332-015 HUMAN PRESCRIPTION DRUG LITHIUM CARBONATE LITHIUM CARBONATE LITHIUM CARBONATE CAPSULE ORAL 20161227 ANDA ANDA079159 Alembic Pharmaceuticals Inc. LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] N 20181231 62332-016_f9fc56cf-79b8-4ab5-b09a-20a27bb19ed7 62332-016 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20161201 ANDA ANDA079067 Alembic Pharmaceuticals Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 62332-017_f9fc56cf-79b8-4ab5-b09a-20a27bb19ed7 62332-017 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20161201 ANDA ANDA079067 Alembic Pharmaceuticals Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 62332-018_f9b4c86c-932b-4b43-ab1a-6d9e07958044 62332-018 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole CAPSULE ORAL 20161209 ANDA ANDA079065 Alembic Pharmaceuticals Inc. METRONIDAZOLE 375 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 62332-019_2f83665d-f4a7-4503-ab05-e34be087fc3e 62332-019 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20160331 ANDA ANDA090122 Alembic Pharmaceuticals Inc. MEPROBAMATE 200 mg/1 CIV N 20181231 62332-020_2f83665d-f4a7-4503-ab05-e34be087fc3e 62332-020 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20160331 ANDA ANDA090122 Alembic Pharmaceuticals Inc. MEPROBAMATE 400 mg/1 CIV N 20181231 62332-022_b124b86e-894f-43db-9b78-42b9599df45d 62332-022 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20160129 ANDA ANDA090223 Alembic Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62332-023_b124b86e-894f-43db-9b78-42b9599df45d 62332-023 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20160129 ANDA ANDA090223 Alembic Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62332-024_b124b86e-894f-43db-9b78-42b9599df45d 62332-024 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20160129 ANDA ANDA090223 Alembic Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62332-025_7d3734c8-d377-4980-b156-fc08a778879f 62332-025 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20160129 ANDA ANDA090430 Alembic Pharmaceuticals Inc. THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 62332-026_7d3734c8-d377-4980-b156-fc08a778879f 62332-026 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20160129 ANDA ANDA090430 Alembic Pharmaceuticals Inc. THEOPHYLLINE ANHYDROUS 450 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 62332-027_1dadbe02-289c-4312-9e65-40f3314dcc31 62332-027 HUMAN PRESCRIPTION DRUG Losatan Potassium Losatan Potassium TABLET, FILM COATED ORAL 20160523 ANDA ANDA090428 Alembic Pharmaceuticals Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-028_1dadbe02-289c-4312-9e65-40f3314dcc31 62332-028 HUMAN PRESCRIPTION DRUG Losatan Potassium Losatan Potassium TABLET, FILM COATED ORAL 20160523 ANDA ANDA090428 Alembic Pharmaceuticals Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-029_1dadbe02-289c-4312-9e65-40f3314dcc31 62332-029 HUMAN PRESCRIPTION DRUG Losatan Potassium Losatan Potassium TABLET, FILM COATED ORAL 20160523 ANDA ANDA090428 Alembic Pharmaceuticals Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-030_e6d75f01-50a3-4373-b88a-67842541fb76 62332-030 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160129 ANDA ANDA090429 Alembic Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 62332-031_e6d75f01-50a3-4373-b88a-67842541fb76 62332-031 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160129 ANDA ANDA090429 Alembic Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 62332-032_e6d75f01-50a3-4373-b88a-67842541fb76 62332-032 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160129 ANDA ANDA090429 Alembic Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 62332-033_e6d75f01-50a3-4373-b88a-67842541fb76 62332-033 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160129 ANDA ANDA090429 Alembic Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 62332-034_e6d75f01-50a3-4373-b88a-67842541fb76 62332-034 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160129 ANDA ANDA090429 Alembic Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 62332-035_e6d75f01-50a3-4373-b88a-67842541fb76 62332-035 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160129 ANDA ANDA090429 Alembic Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 62332-036_e6d75f01-50a3-4373-b88a-67842541fb76 62332-036 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160129 ANDA ANDA090429 Alembic Pharmaceuticals Inc. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 62332-037_60958229-5b5f-49e2-97f4-a8722138f7ce 62332-037 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20180205 ANDA ANDA090607 Alembic Pharmaceuticals Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 62332-038_60958229-5b5f-49e2-97f4-a8722138f7ce 62332-038 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20180205 ANDA ANDA090607 Alembic Pharmaceuticals Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 62332-039_60958229-5b5f-49e2-97f4-a8722138f7ce 62332-039 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20180205 ANDA ANDA090607 Alembic Pharmaceuticals Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 62332-040_60958229-5b5f-49e2-97f4-a8722138f7ce 62332-040 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20180205 ANDA ANDA090607 Alembic Pharmaceuticals Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 62332-041_83f5d5c8-27c0-4208-a291-0c4aa55a1ff5 62332-041 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET ORAL 20160701 ANDA ANDA091236 Alembic Pharmaceuticals Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-042_83f5d5c8-27c0-4208-a291-0c4aa55a1ff5 62332-042 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET ORAL 20160701 ANDA ANDA091236 Alembic Pharmaceuticals Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-043_83f5d5c8-27c0-4208-a291-0c4aa55a1ff5 62332-043 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET ORAL 20160701 ANDA ANDA091236 Alembic Pharmaceuticals Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-044_da08e8a7-c743-4b95-a993-edc98f562801 62332-044 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20160520 ANDA ANDA091367 Alembic Pharmaceuticals Inc. VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-045_da08e8a7-c743-4b95-a993-edc98f562801 62332-045 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20160520 ANDA ANDA091367 Alembic Pharmaceuticals Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-046_da08e8a7-c743-4b95-a993-edc98f562801 62332-046 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20160520 ANDA ANDA091367 Alembic Pharmaceuticals Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-047_da08e8a7-c743-4b95-a993-edc98f562801 62332-047 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20160520 ANDA ANDA091367 Alembic Pharmaceuticals Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-048_8abffade-1b3b-445d-8dd7-02cf9d27f2a8 62332-048 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160523 ANDA ANDA091617 Alembic Pharmaceuticals Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-049_8abffade-1b3b-445d-8dd7-02cf9d27f2a8 62332-049 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160523 ANDA ANDA091617 Alembic Pharmaceuticals Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-050_8abffade-1b3b-445d-8dd7-02cf9d27f2a8 62332-050 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160523 ANDA ANDA091617 Alembic Pharmaceuticals Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-051_6320004a-bd5f-4567-9a60-43b41de052aa 62332-051 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20160523 ANDA ANDA091370 Alembic Pharmaceuticals Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-052_6320004a-bd5f-4567-9a60-43b41de052aa 62332-052 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20160523 ANDA ANDA091370 Alembic Pharmaceuticals Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-053_6320004a-bd5f-4567-9a60-43b41de052aa 62332-053 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20161017 ANDA ANDA091370 Alembic Pharmaceuticals Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-054_61b56917-1442-4068-86d8-0e5a5a59e612 62332-054 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20160503 ANDA ANDA091368 Alembic Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 62332-055_61b56917-1442-4068-86d8-0e5a5a59e612 62332-055 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20160503 ANDA ANDA091368 Alembic Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 62332-056_61b56917-1442-4068-86d8-0e5a5a59e612 62332-056 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20160503 ANDA ANDA091368 Alembic Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 62332-060_504fd1a0-bcc6-45ac-8096-2e04db3b7cc7 62332-060 HUMAN PRESCRIPTION DRUG CANDESARTAN CILEXETIL CANDESARTAN CILEXETIL TABLET ORAL 20170621 ANDA ANDA209119 Alembic Pharmaceuticals Inc. CANDESARTAN CILEXETIL 32 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-061_a42c584c-b248-4335-a30b-0e8b61a27867 62332-061 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20161201 ANDA ANDA091369 Alembic Pharmaceuticals Inc. LEFLUNOMIDE 10 mg/1 Antirheumatic Agent [EPC] N 20181231 62332-062_a42c584c-b248-4335-a30b-0e8b61a27867 62332-062 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20161201 ANDA ANDA091369 Alembic Pharmaceuticals Inc. LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] N 20181231 62332-070_841b7962-bf5d-4c45-b594-80b17ba5187d 62332-070 HUMAN PRESCRIPTION DRUG hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20170302 ANDA ANDA200645 Alembic Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-075_ab1ddbde-2a47-4b84-9421-7c54367f305b 62332-075 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine hydrochloride TABLET, COATED ORAL 20151013 ANDA ANDA200891 Alembic Pharmaceuticals Inc. MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 62332-076_ab1ddbde-2a47-4b84-9421-7c54367f305b 62332-076 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine hydrochloride TABLET, COATED ORAL 20151013 ANDA ANDA200891 Alembic Pharmaceuticals Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 62332-079_7b41a1bc-32b6-431d-a693-e92316175b1e 62332-079 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160520 ANDA ANDA201662 Alembic Pharmaceuticals Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-080_7b41a1bc-32b6-431d-a693-e92316175b1e 62332-080 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160520 ANDA ANDA201662 Alembic Pharmaceuticals Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-081_7b41a1bc-32b6-431d-a693-e92316175b1e 62332-081 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160520 ANDA ANDA201662 Alembic Pharmaceuticals Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-082_7b41a1bc-32b6-431d-a693-e92316175b1e 62332-082 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160520 ANDA ANDA201662 Alembic Pharmaceuticals Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-083_7b41a1bc-32b6-431d-a693-e92316175b1e 62332-083 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160520 ANDA ANDA201662 Alembic Pharmaceuticals Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-087_c62d424c-7630-413c-be2c-3932831c3f1d 62332-087 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20160625 ANDA ANDA202130 Alembic Pharmaceuticals Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-088_c62d424c-7630-413c-be2c-3932831c3f1d 62332-088 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20160625 ANDA ANDA202130 Alembic Pharmaceuticals Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-089_c62d424c-7630-413c-be2c-3932831c3f1d 62332-089 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20160625 ANDA ANDA202130 Alembic Pharmaceuticals Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-092_65e77958-2a79-4470-b924-239f307b6634 62332-092 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20160129 ANDA ANDA201724 Alembic Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 62332-093_65e77958-2a79-4470-b924-239f307b6634 62332-093 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20160129 ANDA ANDA201724 Alembic Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 62332-095_a9c44ae2-0033-4be7-a07e-b934bb7b89ab 62332-095 HUMAN PRESCRIPTION DRUG lamotrigine lamotrigine chewable dispersible TABLET, FOR SUSPENSION ORAL 20140411 ANDA ANDA201168 Alembic Pharmaceuticals Inc. LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 62332-096_a9c44ae2-0033-4be7-a07e-b934bb7b89ab 62332-096 HUMAN PRESCRIPTION DRUG lamotrigine lamotrigine chewable dispersible TABLET, FOR SUSPENSION ORAL 20140411 ANDA ANDA201168 Alembic Pharmaceuticals Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 62332-097_167f9703-266f-4843-8aa4-d066869b51f7 62332-097 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160707 ANDA ANDA202101 Alembic Pharmaceuticals Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 62332-098_167f9703-266f-4843-8aa4-d066869b51f7 62332-098 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160707 ANDA ANDA202101 Alembic Pharmaceuticals Inc. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 62332-099_167f9703-266f-4843-8aa4-d066869b51f7 62332-099 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160707 ANDA ANDA202101 Alembic Pharmaceuticals Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 62332-100_167f9703-266f-4843-8aa4-d066869b51f7 62332-100 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160707 ANDA ANDA202101 Alembic Pharmaceuticals Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 62332-101_167f9703-266f-4843-8aa4-d066869b51f7 62332-101 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160707 ANDA ANDA202101 Alembic Pharmaceuticals Inc. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 62332-102_167f9703-266f-4843-8aa4-d066869b51f7 62332-102 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160707 ANDA ANDA202101 Alembic Pharmaceuticals Inc. ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 62332-103_da9d6643-09c5-4c46-8213-67afb801c578 62332-103 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET, ORALLY DISINTEGRATING ORAL 20160707 ANDA ANDA202102 Alembic Pharmaceuticals Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 62332-104_da9d6643-09c5-4c46-8213-67afb801c578 62332-104 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET, ORALLY DISINTEGRATING ORAL 20160707 ANDA ANDA202102 Alembic Pharmaceuticals Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 62332-105_57c29bec-d763-415e-8ee6-907662200ccf 62332-105 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20160520 ANDA ANDA202700 Alembic Pharmaceuticals Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] N 20181231 62332-106_57c29bec-d763-415e-8ee6-907662200ccf 62332-106 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20160520 ANDA ANDA202700 Alembic Pharmaceuticals Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] N 20181231 62332-112_f60df346-2f8b-4d85-9358-6e11fa4abda7 62332-112 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TABLET ORAL 20160731 ANDA ANDA202871 Alembic Pharmaceuticals Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62332-113_f60df346-2f8b-4d85-9358-6e11fa4abda7 62332-113 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TABLET ORAL 20160731 ANDA ANDA202871 Alembic Pharmaceuticals Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62332-114_f60df346-2f8b-4d85-9358-6e11fa4abda7 62332-114 HUMAN PRESCRIPTION DRUG METOPROLOL TARTRATE METOPROLOL TABLET ORAL 20160731 ANDA ANDA202871 Alembic Pharmaceuticals Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62332-115_a99bf8c0-ee38-4c3b-b286-1b05ba472561 62332-115 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20151015 ANDA ANDA202870 Alembic Pharmaceuticals Inc. METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-116_a99bf8c0-ee38-4c3b-b286-1b05ba472561 62332-116 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20151015 ANDA ANDA202870 Alembic Pharmaceuticals Inc. METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-117_a99bf8c0-ee38-4c3b-b286-1b05ba472561 62332-117 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20151015 ANDA ANDA202870 Alembic Pharmaceuticals Inc. METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 100; 50 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-118_240b7a17-b154-4e7c-a3c1-5f1c0629bcdf 62332-118 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20151031 ANDA ANDA203013 Alembic Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 62332-127_240b7a17-b154-4e7c-a3c1-5f1c0629bcdf 62332-127 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20151031 ANDA ANDA203013 Alembic Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 62332-131_308ee122-5814-46bb-aedb-21c2f47d80c4 62332-131 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA203012 Alembic Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-132_308ee122-5814-46bb-aedb-21c2f47d80c4 62332-132 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA203012 Alembic Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-133_308ee122-5814-46bb-aedb-21c2f47d80c4 62332-133 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA203012 Alembic Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-140_7b3eea55-b074-4d9e-94ca-12b10bbcd57e 62332-140 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20151201 ANDA ANDA204519 Alembic Pharmaceuticals Inc. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 62332-141_7b3eea55-b074-4d9e-94ca-12b10bbcd57e 62332-141 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20151201 ANDA ANDA204519 Alembic Pharmaceuticals Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 62332-142_7b3eea55-b074-4d9e-94ca-12b10bbcd57e 62332-142 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20151201 ANDA ANDA204519 Alembic Pharmaceuticals Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 62332-143_7b3eea55-b074-4d9e-94ca-12b10bbcd57e 62332-143 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20151201 ANDA ANDA204519 Alembic Pharmaceuticals Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 62332-148_62c46c0d-b5d7-4cb6-ae82-6097f0c2a24d 62332-148 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20170221 ANDA ANDA204445 Alembic Pharmaceuticals Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 62332-149_af2556be-98d8-4659-ada4-143caa512fd9 62332-149 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET ORAL 20170424 ANDA ANDA204233 Alembic Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-150_af2556be-98d8-4659-ada4-143caa512fd9 62332-150 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET ORAL 20170424 ANDA ANDA204233 Alembic Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-151_af2556be-98d8-4659-ada4-143caa512fd9 62332-151 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET ORAL 20170424 ANDA ANDA204233 Alembic Pharmaceuticals Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-183_4c413a8f-0fca-488c-8fdc-6e3317195d24 62332-183 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20151222 ANDA ANDA205233 Alembic Pharmaceuticals Inc. LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 62332-204_562e33c5-6b74-4bb3-a36f-0f4a253b5abd 62332-204 HUMAN PRESCRIPTION DRUG ITRACONAZOLE itraconazole CAPSULE ORAL 20161216 ANDA ANDA206741 Alembic Pharmaceuticals Inc. ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62332-205_fbd864d1-65a3-4bbc-b4c8-99efc321f71e 62332-205 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET, FILM COATED ORAL 20161201 ANDA ANDA202713 Alembic Pharmaceuticals Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-206_fbd864d1-65a3-4bbc-b4c8-99efc321f71e 62332-206 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET, FILM COATED ORAL 20161201 ANDA ANDA202713 Alembic Pharmaceuticals Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-207_fbd864d1-65a3-4bbc-b4c8-99efc321f71e 62332-207 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET, FILM COATED ORAL 20161201 ANDA ANDA202713 Alembic Pharmaceuticals Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-208_fbd864d1-65a3-4bbc-b4c8-99efc321f71e 62332-208 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET, FILM COATED ORAL 20161201 ANDA ANDA202713 Alembic Pharmaceuticals Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-209_e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7 62332-209 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20160625 ANDA ANDA203010 Alembic Pharmaceuticals Inc. TELMISARTAN; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-210_e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7 62332-210 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20160625 ANDA ANDA203010 Alembic Pharmaceuticals Inc. TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-211_e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7 62332-211 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20160625 ANDA ANDA203010 Alembic Pharmaceuticals Inc. TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 62332-212_5a87a6c8-18d0-4d9e-96b6-21a236c840ed 62332-212 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Olmesartran medoxomil Amlodipine besylate and Olmesartran medoxomil TABLET, FILM COATED ORAL 20170718 ANDA ANDA207073 Alembic Pharmaceuticals Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-213_5a87a6c8-18d0-4d9e-96b6-21a236c840ed 62332-213 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Olmesartran medoxomil Amlodipine besylate and Olmesartran medoxomil TABLET, FILM COATED ORAL 20170718 ANDA ANDA207073 Alembic Pharmaceuticals Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-214_5a87a6c8-18d0-4d9e-96b6-21a236c840ed 62332-214 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Olmesartran medoxomil Amlodipine besylate and Olmesartran medoxomil TABLET, FILM COATED ORAL 20170718 ANDA ANDA207073 Alembic Pharmaceuticals Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-215_5a87a6c8-18d0-4d9e-96b6-21a236c840ed 62332-215 HUMAN PRESCRIPTION DRUG Amlodipine besylate and Olmesartran medoxomil Amlodipine besylate and Olmesartran medoxomil TABLET, FILM COATED ORAL 20170718 ANDA ANDA207073 Alembic Pharmaceuticals Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 62332-223_b2e68dc7-8636-40cb-a454-c868f1af2f83 62332-223 HUMAN PRESCRIPTION DRUG DARIFENACIN DARIFENACIN TABLET, EXTENDED RELEASE ORAL 20171212 ANDA ANDA207681 Alembic Pharmaceuticals Inc. DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 62332-224_b2e68dc7-8636-40cb-a454-c868f1af2f83 62332-224 HUMAN PRESCRIPTION DRUG DARIFENACIN DARIFENACIN TABLET, EXTENDED RELEASE ORAL 20171212 ANDA ANDA207681 Alembic Pharmaceuticals Inc. DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 62332-242_f2916631-74c5-4643-a1e7-1805f2ee1742 62332-242 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine TABLET, FILM COATED ORAL 20170407 ANDA ANDA208698 Alembic Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62332-243_f2916631-74c5-4643-a1e7-1805f2ee1742 62332-243 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine TABLET, FILM COATED ORAL 20170407 ANDA ANDA208698 Alembic Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62332-244_aea5b7cc-57c3-4fcb-9e83-9ea851a4bbcb 62332-244 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20170515 ANDA ANDA208705 Alembic Pharmaceuticals Inc. FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 62332-245_aea5b7cc-57c3-4fcb-9e83-9ea851a4bbcb 62332-245 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20170515 ANDA ANDA208705 Alembic Pharmaceuticals Inc. FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 62332-246_6cacda05-2b85-402e-930c-e1f20d6fe8ec 62332-246 HUMAN PRESCRIPTION DRUG amantadine amantadine CAPSULE ORAL 20170622 ANDA ANDA208966 Alembic Pharmaceuticals Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 62332-249_68fd27d5-938c-4a03-8316-f1cebbca871c 62332-249 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20170731 ANDA ANDA209165 Alembic Pharmaceuticals Inc. DOXYCYCLINE 75 mg/1 N 20181231 62332-250_68fd27d5-938c-4a03-8316-f1cebbca871c 62332-250 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20170731 ANDA ANDA209165 Alembic Pharmaceuticals Inc. DOXYCYCLINE 100 mg/1 N 20181231 62332-385_41f9ddbd-5228-4f0c-b0aa-2056af79a21e 62332-385 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20170630 ANDA ANDA202700 Alembic Pharmaceuticals Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] N 20181231 62332-386_41f9ddbd-5228-4f0c-b0aa-2056af79a21e 62332-386 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20170630 ANDA ANDA202700 Alembic Pharmaceuticals Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] N 20181231 62333-111_06967632-a24b-4654-ae56-23410f7b1d3a 62333-111 HUMAN OTC DRUG Ivy Block Bentoquatam LOTION TOPICAL 20030303 NDA NDA020532 Standard Homeopathic Comapny QUATERNIUM-18; SODIUM BENTONITE 1.7; 3.3 g/100mL; g/100mL N 20181231 62337-415_820a2d49-ad97-41ce-bfdc-fae3c92cb62f 62337-415 HUMAN OTC DRUG Pyrantel Pamoate PinwormTreatment SUSPENSION ORAL 20121017 OTC MONOGRAPH FINAL part357B Neogen Corporation dba Columbia Laboratories PYRANTEL PAMOATE 50 mg/mL E 20171231 62340-001_8ebd4bf9-e0fe-425d-88a6-d7e4d74ae38f 62340-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19980101 UNAPPROVED MEDICAL GAS University of Michigan Health System dba MedEquip OXYGEN 99 L/100L E 20171231 62362-012_9ce1bc91-5714-4c32-b4c6-1e8a96f907fc 62362-012 HUMAN PRESCRIPTION DRUG Neova Complex HQ Plus Hydroquinone EMULSION TOPICAL 20120109 UNAPPROVED DRUG OTHER PhotoMedex, Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] E 20171231 62362-119_e42c5d41-b58a-41c1-834b-ea55a83bd685 62362-119 HUMAN OTC DRUG Neova Breakout Control Salicylic Acid SWAB TOPICAL 20111227 OTC MONOGRAPH FINAL part358B PhotoMedex, Inc. SALICYLIC ACID 2 mL/100mL E 20171231 62362-129_657c11fe-04b0-46aa-bbbd-6b740934f08c 62362-129 HUMAN OTC DRUG Neova DNA Damage Control - Active SPF 45 Zinc Oxide, Octinoxate, Octisalate EMULSION TOPICAL 20120106 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. ZINC OXIDE; OCTINOXATE; OCTISALATE 8; 7.5; 3 mL/100mL; mL/100mL; mL/100mL E 20171231 62362-129_c1d6e09b-2903-44ed-84a9-8701a702e19e 62362-129 HUMAN OTC DRUG Neova DNA Damage Control - Active SPF 45 Zinc Oxide, Octinoxate, Octisalate EMULSION TOPICAL 20120105 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. ZINC OXIDE; OCTINOXATE; OCTISALATE 8; 7.5; 3 mL/100mL; mL/100mL; mL/100mL E 20171231 62362-139_9434e317-85ce-44f4-ac99-dbe37d5f6b6c 62362-139 HUMAN OTC DRUG Neova DNA Damage Control - Everyday SPF 43 Zinc Oxide, Octinoxate, Octisalate EMULSION TOPICAL 20120106 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. ZINC OXIDE; OCTINOXATE; OCTISALATE 7.5; 7.5; 2.5 mL/100mL; mL/100mL; mL/100mL E 20171231 62362-139_a4c08463-942b-4f1d-a483-1d56aee78d85 62362-139 HUMAN OTC DRUG Neova DNA Damage Control - Everyday SPF 43 Zinc Oxide, Octinoxate, Octisalate EMULSION TOPICAL 20120106 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. ZINC OXIDE; OCTINOXATE; OCTISALATE 7.5; 7.5; 2.5 mL/100mL; mL/100mL; mL/100mL E 20171231 62362-149_0542c9e9-5d1f-4485-9568-fe9f48b1d220 62362-149 HUMAN OTC DRUG Neova DNA Damage Control - Silc Sheer SPF 45 Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120109 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. OCTINOXATE; TITANIUM DIOXIDE 6.5; 3.5 mL/100mL; mL/100mL E 20171231 62362-149_cc4ff974-a89e-4731-a823-4be5d3869f24 62362-149 HUMAN OTC DRUG Neova DNA Damage Control - Silc Sheer SPF 45 Octinoxate, Titanium Dioxide EMULSION TOPICAL 20120106 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. OCTINOXATE; TITANIUM DIOXIDE 6.5; 3.5 mL/100mL; mL/100mL E 20171231 62362-159_49d543b3-13b4-480e-82a5-acb565474a38 62362-159 HUMAN OTC DRUG Neova DNA Damage Control - Everyday Broad Spectrum SPF 44 Octinoxate, Octisalate, Zinc Oxide EMULSION TOPICAL 20121008 OTC MONOGRAPH NOT FINAL part352 PhotoMedex, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 6.5; 2.5; 8.5 g/100mL; g/100mL; g/100mL E 20171231 62362-169_d0dfabc7-480a-4048-b07e-080127d7c18d 62362-169 HUMAN OTC DRUG Neova DNA Damage Control - Silc Sheer Broad Spectrum SPF 40 Octinoxate, Titanium Dioxide, Zinc Oxide EMULSION TOPICAL 20121008 OTC MONOGRAPH NOT FINAL part352 PhotoMedex, Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 3; 9 g/100mL; g/100mL; g/100mL E 20171231 62362-179_9cf6b022-df2a-430a-b216-3f7ec60d657f 62362-179 HUMAN OTC DRUG Neova DNA Damage Control - Active Broad Spectrum SPF 43 Octinoxate, Zinc Oxide EMULSION TOPICAL 20121008 OTC MONOGRAPH NOT FINAL part352 PhotoMedex, Inc. OCTINOXATE; ZINC OXIDE 7.5; 9 g/100mL; g/100mL E 20171231 62362-184_71d74dfb-e777-4152-a09b-cbec4aab35b9 62362-184 HUMAN OTC DRUG Neova Day Therapy SPF 30 Homosalate, Octocrylene, Octisalate, Avobenzone LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 PhotoMedex, Inc HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 7; 6; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 62362-184_a752b6e4-63cd-4812-9e70-82829e1a72dd 62362-184 HUMAN OTC DRUG Neova Day Therapy SPF 30 Homosalate, Octocrylene, Octisalate, Avobenzone LOTION TOPICAL 20120111 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 7; 6; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 62362-184_adc0c9f7-391a-46d8-aff7-015f380eac70 62362-184 HUMAN OTC DRUG Neova Day Therapy SPF 30 Homosalate, Octocrylene, Octisalate, Avobenzone LOTION TOPICAL 20120111 OTC MONOGRAPH FINAL part352 PhotoMedex, Inc. HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 7; 6; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 62366-124_f41c58a1-991e-462e-a3aa-d6fc02683e76 62366-124 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20140113 OTC MONOGRAPH NOT FINAL part333A Medical Speciaties Distributors, LLC ISOPROPYL ALCOHOL .7 mL/mL N 20181231 62372-500_9abb6196-5484-438a-9eb8-8de54246bf04 62372-500 HUMAN OTC DRUG Mylanta Maximum Strength Classic Flavor Antacid and Anti Gas Aluminum hydroxide Magnesium hydroxide and Simethicone SUSPENSION ORAL 20161110 OTC MONOGRAPH FINAL part331 Infirst Healthcare Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 62372-504_45bc9dba-463b-4d6a-a028-09dfc3bf9406 62372-504 HUMAN OTC DRUG Mylanta Maximum Strength Vanilla Caramel Flavor Antacid and Anti Gas Aluminum hydroxide Magnesium hydroxide and Simethicone SUSPENSION ORAL 20160321 OTC MONOGRAPH FINAL part331 Infirst Healthcare Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 62372-510_73d3f4f2-8bab-4613-967e-4bafdc91ccc8 62372-510 HUMAN OTC DRUG Mylanta New Tonight Soothing Honey Chamomile Calcium Carbonate,Magnesium hydroxide and Simethicone SUSPENSION ORAL 20160321 OTC MONOGRAPH FINAL part331 Infirst Healthcare Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 270; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 62372-630_a4472d82-7d48-40d0-851b-8f91e3541bcf 62372-630 HUMAN OTC DRUG Mylicon Infants Gas Relief Original Simethicone EMULSION ORAL 20150331 OTC MONOGRAPH FINAL part332 Infirst Healthcare DIMETHICONE 20 mg/.3mL N 20181231 62372-650_99383855-aad0-49cf-80c7-9183977c5743 62372-650 HUMAN OTC DRUG Mylicon Infants Gas Relief Dye Free Simethicone EMULSION ORAL 20150331 OTC MONOGRAPH FINAL part332 Infirst Healthcare DIMETHICONE 20 mg/.3mL N 20191231 62372-721_614560f9-9cfb-f46f-e053-2991aa0a9c23 62372-721 HUMAN OTC DRUG Dr. Cocoa Daytime Cough and Cold Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140620 OTC MONOGRAPH FINAL part341 Infirst Healthcare DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 62372-743_6145a2ee-4594-5f41-e053-2a91aa0a4a10 62372-743 HUMAN OTC DRUG Dr. Cocoa Nighttime Cough and Cold Diphenhydramine Hydrchloride, Phenylephrine Hydrochloride LIQUID ORAL 20140620 OTC MONOGRAPH FINAL part341 Infirst Healthcare DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 62372-800_13c3b999-8ace-489a-8cd1-0ebd291c91a8 62372-800 HUMAN OTC DRUG Mylanta Gas Minis Mint Flavor Simethicone TABLET, CHEWABLE ORAL 20160321 OTC MONOGRAPH FINAL part332 Infirst Healthcare Inc. DIMETHICONE 125 mg/1 N 20181231 62372-801_c290b888-d50d-4722-978b-712150853307 62372-801 HUMAN OTC DRUG Mylanta Gas Minis Assorted Fruit Flavor Simethicone TABLET, CHEWABLE ORAL 20160321 OTC MONOGRAPH FINAL part332 Infirst Healthcare Inc. DIMETHICONE 125 mg/1 N 20181231 62372-802_e248421a-e41d-46e7-a18b-767ba40d8420 62372-802 HUMAN OTC DRUG Mylanta Gas Minis Cherry Flavor Simethicone TABLET, CHEWABLE ORAL 20160321 OTC MONOGRAPH FINAL part332 Infirst Healthcare Inc. DIMETHICONE 125 mg/1 N 20181231 62377-001_36e0d164-d8f0-436c-8c1f-25750028e634 62377-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 19950101 NDA NDA205865 EWS Welding Supply, Inc. OXYGEN 995 mL/L N 20181231 62379-001_0fc7f516-d1ee-258c-e054-00144ff8d46c 62379-001 HUMAN OTC DRUG cold hot patch Menthol PATCH TOPICAL 20150223 OTC MONOGRAPH NOT FINAL part348 Simple Diagnostics, Inc. MENTHOL 5 g/100g E 20171231 62379-005_379f99c1-30c7-5d5c-e054-00144ff8d46c 62379-005 HUMAN OTC DRUG PHARMACIST CHOICE ALCOHOL STERILE PREP PAD isopropyl alcohol SWAB TOPICAL 20150223 OTC MONOGRAPH NOT FINAL part333A Simple Diagnostics. Inc. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 62379-005_5b24e125-8788-c923-e053-2991aa0abfc5 62379-005 HUMAN OTC DRUG PHARMACIST CHOICE ALCOHOL STERILE PREP PAD isopropyl alcohol SWAB TOPICAL 20150223 OTC MONOGRAPH NOT FINAL part333A Simple Diagnostics. Inc. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 62382-0308_0685b7dd-995c-5175-e054-00144ff8d46c 62382-0308 HUMAN OTC DRUG Easy to break-off cleaning and disinfecting swabstick JJB-I Alcohol swabstick SWAB TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Longood Medicine (Beijing) Co., Ltd. ALCOHOL .7 mL/mL E 20171231 62382-0315_957329b1-17ac-49d4-b01c-3d39815a9c6d 62382-0315 HUMAN OTC DRUG Easy to break-off cleaning and disinfecting swabstick YBC-I Isopropyl alcohol swabstick SWAB TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Longood Medicine (Beijing) Co., Ltd. ISOPROPYL ALCOHOL .7 mL/mL E 20171231 62382-0322_f335c19a-4871-40e5-9e38-bf084b68eb5a 62382-0322 HUMAN OTC DRUG Easy to break-off cleaning and disinfecting swabstick DFB-I Povidone iodine swabstick SWAB TOPICAL 20140328 OTC MONOGRAPH NOT FINAL part333A Longood Medicine (Beijing) Co., Ltd. POVIDONE-IODINE .1 mg/mL E 20171231 62382-0323_11205be3-1a69-4a69-ac14-a18e8fe7ffac 62382-0323 HUMAN OTC DRUG Easy to break-off cleaning and disinfecting swabstick DFB-I Isopropyl Alcohol SWAB TOPICAL 20150328 OTC MONOGRAPH NOT FINAL part333A Longood Medicine (Beijing) Co., Ltd. ISOPROPYL ALCOHOL .7 mL/mL E 20171231 62382-0324_8c1ab116-be30-43f0-8a71-ff2dcc451946 62382-0324 HUMAN OTC DRUG CHG Isopropyl Alcohol SWAB TOPICAL 20150828 OTC MONOGRAPH NOT FINAL part333A Longood Medicine (Beijing) Co., Ltd. ISOPROPYL ALCOHOL .7 mL/mL E 20171231 62391-001_0b669957-1ea3-45ff-83a4-851ee52b5e51 62391-001 HUMAN OTC DRUG BioFlexor Menthol GEL TOPICAL 19980301 OTC MONOGRAPH FINAL part346 Health Care Laboratories Inc. MENTHOL .03 g/g E 20171231 62400-0033_4f1cdeaa-1f6f-4e99-e054-00144ff88e88 62400-0033 HUMAN OTC DRUG Pain Relieving Foot APIS MELLIFERA PSEUDOGNAPHALIUM OBTUSIFOLIUM GELSEMIUM SEMPERVIRENS ROOT CREAM TOPICAL 20170505 UNAPPROVED HOMEOPATHIC United Laboratories Manufacturing, LLC PSEUDOGNAPHALIUM OBTUSIFOLIUM; APIS MELLIFERA; GELSEMIUM SEMPERVIRENS ROOT 6; 3; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 62428-505_4ce03b23-3b02-41b0-ab8d-148a5e4dd5f4 62428-505 HUMAN OTC DRUG Drummond American Trade Wind Antimicrobial Chloroxylenol LIQUID TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333 Lawson Products, Inc. CHLOROXYLENOL 10.22 g/1000mL E 20171231 62440-279_6003ca05-8d2b-46d4-b976-006c03636c0d 62440-279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20140305 OTC MONOGRAPH NOT FINAL part333A Swinton Avenue Trading Ltd.Inc. BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 62440-370_95742b8f-a9ca-498d-b0b1-e6194e26cda9 62440-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333A Swinton Avenue Trading Ltd, Inc. ALCOHOL 70 mL/100mL N 20181231 62440-439_74c281e7-afa2-4d90-8ce4-ba6d48b58749 62440-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333A Swinton Avenue Trading LTD.Inc. ALCOHOL 700 mg/mL N 20181231 62442-001_dbccd9f3-472d-4233-83bd-5a892db4591e 62442-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS Mediserve Medical Equipment, Inc. OXYGEN 99 L/100L E 20171231 62447-0010_1dc038e0-87cc-4833-b66e-7861ccabf68a 62447-0010 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19870101 NDA NDA205767 Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply OXYGEN 99 L/100L N 20181231 62450-001_9194048e-5b6d-4f5d-b410-79cca5382ff2 62450-001 HUMAN OTC DRUG Attends Daily Barrier Dimethicone, Zinc Oxide SPRAY TOPICAL 20140306 OTC MONOGRAPH FINAL part347 Purna Pharmaceuticals NV ZINC OXIDE; DIMETHICONE 4; 2 g/99g; g/99g E 20171231 62450-002_0e4eb444-7f9f-495f-a3f3-b3c5bbdc858c 62450-002 HUMAN OTC DRUG Attends Advanced Barrier Zinc Oxide SPRAY TOPICAL 20140306 OTC MONOGRAPH FINAL part347 Purna Pharmaceuticals NV ZINC OXIDE 10 g/99g E 20171231 62476-100_2be5226a-e36a-7495-e054-00144ff8d46c 62476-100 HUMAN OTC DRUG Jabonito Fresh Triclosan SOAP TOPICAL 20160126 OTC MONOGRAPH NOT FINAL part333E Industria LA Popular SA TRICLOSAN .0005 g/g N 20181231 62481-4565_170cd797-4654-4840-a660-b01dedce6631 62481-4565 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19970401 UNAPPROVED MEDICAL GAS Bay State Medical, Inc. OXYGEN 99 L/100L E 20171231 62484-0020_1fd9fb6c-86c3-49aa-87fb-d3ad3560e3af 62484-0020 HUMAN PRESCRIPTION DRUG PURIXAN Purixan SUSPENSION ORAL 20140428 NDA NDA205919 Nova Laboratories, Ltd MERCAPTOPURINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 62486-130_efd2f6f7-a340-448b-8d8b-f55c91aa24f2 62486-130 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS Advocate Home Care Products OXYGEN 99 L/100L E 20171231 62499-384_a1bf5e85-1fd0-4050-8071-f15f3bc6042b 62499-384 HUMAN OTC DRUG SEBOBALANCE Spot Control Salicylic Acid GEL TOPICAL 20100630 OTC MONOGRAPH FINAL part358H Laboratoire Dr. Renaud SALICYLIC ACID 1 g/100g E 20171231 62499-392_0786cbe9-dc97-45e2-b3b0-35a2aa08db31 62499-392 HUMAN OTC DRUG CLEAR UP Control Solution Anti-Blemiches SALICYLIC ACID GEL TOPICAL 20100629 OTC MONOGRAPH FINAL part358H Laboratoire Dr. Renaud SALICYLIC ACID 2 g/100g E 20171231 62499-394_94f6aeed-9e30-459d-8d1f-dbbaa07c1b15 62499-394 HUMAN OTC DRUG CLEAR UP Cleansing Salicylic Acid GEL TOPICAL 20100628 OTC MONOGRAPH FINAL part358H Laboratoire Dr. Renaud SALICYLIC ACID 2 g/100g E 20171231 62499-395_54210f16-ce52-4575-85c3-a5e8b9f58f52 62499-395 HUMAN OTC DRUG CLEAR UP Prep Salicylic Acid GEL TOPICAL 20100701 OTC MONOGRAPH FINAL part358H Laboratoire Dr. Renaud SALICYLIC ACID 2 g/100g E 20171231 62499-420_9d8f4ada-04b4-4bcb-a3b3-ab5e5ad0693f 62499-420 HUMAN OTC DRUG SPF 15 Protective Balm with UVA/UVB Sunscreens Octinoxate Octisalate Oxybenzone STICK TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part352 Laboratoire Dr Renaud inc. OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 3; 3 g/100g; g/100g; g/100g E 20171231 62499-445_2362cebc-f7d7-468f-930f-a85e96afad5d 62499-445 HUMAN OTC DRUG SPF 15 Anti-shine moisturizing OCTINOXATE and OCTOCRYLENE LOTION TOPICAL 20111129 OTC MONOGRAPH FINAL part352 Laboratoire Dr Renaud Inc. OCTINOXATE; OCTOCRYLENE 7.77; .1 g/100g; g/100g E 20171231 62499-535_6d00776f-043e-4e47-974d-a9f6fa630108 62499-535 HUMAN OTC DRUG SEBOBALANCE Purifying Sebo-absorbing Mask Salicylic Acid PASTE TOPICAL 20100629 OTC MONOGRAPH FINAL part358H Laboratoire Dr. Renaud SALICYLIC ACID 1 g/100g E 20171231 62504-968_ab5cbf83-c8b2-4773-b1a1-4b79a79a79e5 62504-968 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Cryogenic Medical Gases, LLC OXYGEN 99 L/100L E 20171231 62510-001_1294cf87-f0c3-4969-e054-00144ff88e88 62510-001 HUMAN OTC DRUG RADICAL SKINCARE SKIN PERFECTING SCREEN SPF 30 ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20140210 OTC MONOGRAPH NOT FINAL part352 RADICAL BEAUTY USA INC ZINC OXIDE; TITANIUM DIOXIDE 77.5; 58.7 mg/mL; mg/mL E 20171231 62541-201_60df6c4d-fc20-eb49-e053-2a91aa0a61a2 62541-201 HUMAN PRESCRIPTION DRUG Qsymia phentermine and topiramate CAPSULE, EXTENDED RELEASE ORAL 20120917 NDA NDA022580 Vivus, Inc. PHENTERMINE HYDROCHLORIDE; TOPIRAMATE 3.75; 23 mg/1; mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] CIV N 20181231 62541-202_60df6c4d-fc20-eb49-e053-2a91aa0a61a2 62541-202 HUMAN PRESCRIPTION DRUG Qsymia phentermine and topiramate CAPSULE, EXTENDED RELEASE ORAL 20120917 NDA NDA022580 Vivus, Inc. PHENTERMINE HYDROCHLORIDE; TOPIRAMATE 7.5; 46 mg/1; mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] CIV N 20181231 62541-203_60df6c4d-fc20-eb49-e053-2a91aa0a61a2 62541-203 HUMAN PRESCRIPTION DRUG Qsymia phentermine and topiramate CAPSULE, EXTENDED RELEASE ORAL 20120917 NDA NDA022580 Vivus, Inc. PHENTERMINE HYDROCHLORIDE; TOPIRAMATE 11.25; 69 mg/1; mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] CIV N 20181231 62541-204_60df6c4d-fc20-eb49-e053-2a91aa0a61a2 62541-204 HUMAN PRESCRIPTION DRUG Qsymia phentermine and topiramate CAPSULE, EXTENDED RELEASE ORAL 20120917 NDA NDA022580 Vivus, Inc. PHENTERMINE HYDROCHLORIDE; TOPIRAMATE 15; 92 mg/1; mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] CIV N 20181231 62542-301_64528289-cc14-4777-b66a-bc4f451f1cb5 62542-301 HUMAN PRESCRIPTION DRUG Hydrocodone Polistirex and Chlorpheniramine Polistirex Hydrocodone Polistirex and Chlorpheniramine Polistirex SUSPENSION, EXTENDED RELEASE ORAL 20141023 ANDA ANDA091671 Neos Therapeutics, LP HYDROCODONE; CHLORPHENIRAMINE 10; 8 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII N 20181231 62558-001_1d2c493b-6cb6-4540-9ea2-3a4a909da71e 62558-001 HUMAN OTC DRUG Doctor Manzanilla Cough Suppressant and Nasal Decongestant DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE SOLUTION ORAL 20140304 OTC MONOGRAPH FINAL part341 Mid Valley Pharmaceuticals LLC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/5mL; mg/5mL E 20171231 62558-002_e0ce270e-07ac-44a4-bc74-5452d85c10ab 62558-002 HUMAN OTC DRUG Doctor Manzanilla Allergy and Decongestant Relief Doctor Manzanilla Allergy and Decongestant Relief SYRUP ORAL 20170112 OTC MONOGRAPH FINAL part341 Mid Valley Pharmaceuticals LLC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/5mL; mg/5mL N 20181231 62558-003_5e99c064-aa07-45d3-9b2f-24d62494ee9a 62558-003 HUMAN OTC DRUG DOCTOR MANZANILLA COUGH AND COLD DOCTOR MANZANILLA COUGH AND COLD SYRUP ORAL 20170109 OTC MONOGRAPH FINAL part341 Mid Valley Pharmaceuticals LLC DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 12.5; 5 mg/5mL; mg/5mL N 20181231 62559-111_d4bc2ca3-fdb5-4a08-a4d3-f0eea6d49827 62559-111 HUMAN PRESCRIPTION DRUG Cortenema Hydrocortisone ENEMA RECTAL 20120810 NDA NDA016199 ANI Pharmaceuticals, Inc. HYDROCORTISONE 100 mg/60mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 62559-138_4dc1883e-ae11-44c5-8baf-e5eedf1f9ccc 62559-138 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone ENEMA RECTAL 20120816 NDA AUTHORIZED GENERIC NDA016199 ANI Pharmaceuticals, Inc. HYDROCORTISONE 100 mg/60mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 62559-149_b2184dc3-33ca-4f0a-8e6c-794686d04eb7 62559-149 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET ORAL 20101222 UNAPPROVED DRUG OTHER ANI Pharmaceuticals, Inc. ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE 1.25; 2.5 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 62559-150_b2184dc3-33ca-4f0a-8e6c-794686d04eb7 62559-150 HUMAN PRESCRIPTION DRUG Esterified Estrogens and Methyltestosterone Esterified Estrogens and Methyltestosterone TABLET ORAL 20101222 UNAPPROVED DRUG OTHER ANI Pharmaceuticals, Inc. ESTROGENS, ESTERIFIED; METHYLTESTOSTERONE .625; 1.25 mg/1; mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 62559-151_d2606b57-bc72-4518-a51e-1e64bcff1750 62559-151 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20151013 ANDA ANDA204979 ANI Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 62559-152_93cebf78-25e1-4cbf-916f-e29fbc9dc8a2 62559-152 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20170901 ANDA ANDA203447 ANI Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 62559-153_8ca944aa-adb8-434b-87d9-745af5d87c3c 62559-153 HUMAN PRESCRIPTION DRUG Opium Tincture Deodorized morphine tincture SOLUTION ORAL 20110225 UNAPPROVED DRUG OTHER ANI Pharmaceuticals, Inc. MORPHINE 1 g/100mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 62559-158_fa143cd5-90aa-496f-ac84-f40e9756f05b 62559-158 HUMAN PRESCRIPTION DRUG fluvoxamine maleate Fluvoxamine maleate TABLET, COATED ORAL 20110809 NDA AUTHORIZED GENERIC NDA021519 ANI Pharmaceuticals, Inc. FLUVOXAMINE MALEATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62559-159_fa143cd5-90aa-496f-ac84-f40e9756f05b 62559-159 HUMAN PRESCRIPTION DRUG fluvoxamine maleate Fluvoxamine maleate TABLET, COATED ORAL 20110809 NDA AUTHORIZED GENERIC NDA021519 ANI Pharmaceuticals, Inc. FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62559-160_fa143cd5-90aa-496f-ac84-f40e9756f05b 62559-160 HUMAN PRESCRIPTION DRUG fluvoxamine maleate Fluvoxamine maleate TABLET, COATED ORAL 20110809 NDA AUTHORIZED GENERIC NDA021519 ANI Pharmaceuticals, Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 62559-165_6a2a93fa-0050-425c-8bd9-93ed72609b43 62559-165 HUMAN PRESCRIPTION DRUG Reglan Metoclopramide Hydrochloride TABLET ORAL 20110705 NDA NDA017854 ANI Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 62559-166_6a2a93fa-0050-425c-8bd9-93ed72609b43 62559-166 HUMAN PRESCRIPTION DRUG Reglan Metoclopramide Hydrochloride TABLET ORAL 20110705 NDA NDA017854 ANI Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 62559-167_4f9e49c1-4fe5-470f-9455-8bc1a8f44453 62559-167 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20160610 ANDA ANDA205177 ANI Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 62559-173_8d6d69d9-891a-4587-8c70-a74f46232c56 62559-173 HUMAN PRESCRIPTION DRUG Nilutamide Nilutamide TABLET ORAL 20160718 ANDA ANDA207631 ANI Pharmaceuticals, Inc. NILUTAMIDE 150 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 62559-190_77b94960-41e3-4b61-8d55-5044648cfa33 62559-190 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide SOLUTION ORAL 20150518 ANDA ANDA071402 ANI Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 62559-210_749353c9-b71f-4e41-a30a-7ea4a91e6e47 62559-210 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE ORAL 20151101 ANDA ANDA201832 ANI Pharmaceuticals, Inc. NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 62559-230_9fd3c462-402c-486b-a0bc-56e6d008b967 62559-230 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride TABLET, COATED ORAL 20150331 ANDA ANDA076550 ANI Pharmaceuticals, Inc. PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] N 20181231 62559-231_9fd3c462-402c-486b-a0bc-56e6d008b967 62559-231 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride TABLET, COATED ORAL 20150331 ANDA ANDA076550 ANI Pharmaceuticals, Inc. PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] N 20181231 62559-232_9fd3c462-402c-486b-a0bc-56e6d008b967 62559-232 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride Propafenone Hydrochloride TABLET, COATED ORAL 20150331 ANDA ANDA076550 ANI Pharmaceuticals, Inc. PROPAFENONE HYDROCHLORIDE 300 mg/1 Antiarrhythmic [EPC] N 20181231 62559-240_dda5c525-5089-4027-9cf6-89918bf39d4b 62559-240 HUMAN PRESCRIPTION DRUG Methazolamide Methazolamide TABLET ORAL 20141106 ANDA ANDA040001 ANI Pharmaceuticals, Inc. METHAZOLAMIDE 25 mg/1 N 20181231 62559-241_dda5c525-5089-4027-9cf6-89918bf39d4b 62559-241 HUMAN PRESCRIPTION DRUG Methazolamide Methazolamide TABLET ORAL 20141106 ANDA ANDA040001 ANI Pharmaceuticals, Inc. METHAZOLAMIDE 50 mg/1 N 20181231 62559-250_8d1a7163-ea8a-42f2-8ade-5d21ad71c0bd 62559-250 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20150309 ANDA ANDA075126 ANI Pharmaceuticals, Inc. ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 62559-251_8d1a7163-ea8a-42f2-8ade-5d21ad71c0bd 62559-251 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20150201 ANDA ANDA075126 ANI Pharmaceuticals, Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 62559-280_6886ade7-15a9-44b5-9680-fc27e9d54c1a 62559-280 HUMAN PRESCRIPTION DRUG LITHOBID lithium carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140701 NDA NDA018027 ANI Pharmaceuticals, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 62559-310_1687fc63-03b8-44b8-bc63-e970b630bdfa 62559-310 HUMAN PRESCRIPTION DRUG Vancocin vancomycin hydrochloride CAPSULE ORAL 20141117 NDA NDA050606 ANI Pharmaceuticals, Inc. VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 62559-311_1687fc63-03b8-44b8-bc63-e970b630bdfa 62559-311 HUMAN PRESCRIPTION DRUG Vancocin vancomycin hydrochloride CAPSULE ORAL 20141117 NDA NDA050606 ANI Pharmaceuticals, Inc. VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 62559-340_bac1caa7-da65-4a36-a51c-1bd46c782beb 62559-340 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate Extended-Release Tablet TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161221 NDA AUTHORIZED GENERIC NDA018027 ANI Pharmaceuticals, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 62559-380_6301dac5-2406-48c1-ae6c-7a3a660b52a9 62559-380 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate Tablet TABLET ORAL 20151228 ANDA ANDA075882 ANI Pharmaceuticals, Inc. FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] N 20181231 62559-381_6301dac5-2406-48c1-ae6c-7a3a660b52a9 62559-381 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate Tablet TABLET ORAL 20151228 ANDA ANDA075882 ANI Pharmaceuticals, Inc. FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 62559-382_6301dac5-2406-48c1-ae6c-7a3a660b52a9 62559-382 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate Tablet TABLET ORAL 20151228 ANDA ANDA075882 ANI Pharmaceuticals, Inc. FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 62559-390_dfaef0be-8df2-4258-96b6-c9ea5002970c 62559-390 HUMAN PRESCRIPTION DRUG vancomycin hydrochloride vancomycin hydrochloride CAPSULE ORAL 20151026 NDA AUTHORIZED GENERIC NDA050606 ANI Pharmaceuticals, Inc. VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 62559-391_dfaef0be-8df2-4258-96b6-c9ea5002970c 62559-391 HUMAN PRESCRIPTION DRUG vancomycin hydrochloride vancomycin hydrochloride CAPSULE ORAL 20151026 NDA AUTHORIZED GENERIC NDA050606 ANI Pharmaceuticals, Inc. VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 62559-420_cc3ed8af-ec24-435a-9ef0-ad73ba05d3cf 62559-420 HUMAN PRESCRIPTION DRUG Mesalamine Mesalamine ENEMA RECTAL 20160513 NDA AUTHORIZED GENERIC NDA019618 ANI Pharmaceuticals, Inc. MESALAMINE 4 g/60mL Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 62559-430_5ee61506-935f-4129-be09-594309b7f6bc 62559-430 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20160401 ANDA ANDA080706 ANI Pharmaceuticals, Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 62559-431_5ee61506-935f-4129-be09-594309b7f6bc 62559-431 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20160401 ANDA ANDA080706 ANI Pharmaceuticals, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 62559-440_4a75b0e0-f29c-4056-9e48-a5a91ffaf78d 62559-440 HUMAN PRESCRIPTION DRUG Erythromycin Ethylsuccinate Erythromycin Ethylsuccinate GRANULE, FOR SUSPENSION ORAL 20160927 ANDA ANDA062055 ANI Pharmaceuticals, Inc. ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 62559-460_b1958622-6133-4c57-bc60-b58c7f0b58f1 62559-460 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20160413 NDA AUTHORIZED GENERIC NDA021612 ANI Pharmaceuticals, Inc. FENOFIBRATE 50 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 62559-461_b1958622-6133-4c57-bc60-b58c7f0b58f1 62559-461 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20160413 NDA AUTHORIZED GENERIC NDA021612 ANI Pharmaceuticals, Inc. FENOFIBRATE 150 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 62559-490_f73300ac-007e-41db-a2d0-14415b490386 62559-490 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20170707 ANDA ANDA086727 ANI Pharmaceuticals, Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 62559-510_af9db639-390d-41e3-b1e1-71bdae9a3b17 62559-510 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20170424 ANDA ANDA074299 ANI Pharmaceuticals, Inc. INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 62559-511_af9db639-390d-41e3-b1e1-71bdae9a3b17 62559-511 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20170424 ANDA ANDA074299 ANI Pharmaceuticals, Inc. INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 62559-520_35d28979-36b1-4630-b85e-a44e0a443734 62559-520 HUMAN PRESCRIPTION DRUG INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170428 NDA NDA018553 ANI Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62559-521_35d28979-36b1-4630-b85e-a44e0a443734 62559-521 HUMAN PRESCRIPTION DRUG INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170428 NDA NDA018553 ANI Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62559-522_35d28979-36b1-4630-b85e-a44e0a443734 62559-522 HUMAN PRESCRIPTION DRUG INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170428 NDA NDA018553 ANI Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62559-523_35d28979-36b1-4630-b85e-a44e0a443734 62559-523 HUMAN PRESCRIPTION DRUG INDERAL LA propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170428 NDA NDA018553 ANI Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62559-530_5415904b-90da-48e8-9f9e-f86749aa129c 62559-530 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171221 NDA AUTHORIZED GENERIC NDA018553 ANI Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62559-531_5415904b-90da-48e8-9f9e-f86749aa129c 62559-531 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171221 NDA AUTHORIZED GENERIC NDA018553 ANI Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62559-532_5415904b-90da-48e8-9f9e-f86749aa129c 62559-532 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171221 NDA AUTHORIZED GENERIC NDA018553 ANI Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62559-533_5415904b-90da-48e8-9f9e-f86749aa129c 62559-533 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171221 NDA AUTHORIZED GENERIC NDA018553 ANI Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62559-540_9c970c69-6d60-43db-be4c-6717558455e6 62559-540 HUMAN PRESCRIPTION DRUG Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate INJECTION INTRAMUSCULAR 20160603 20180731 ANDA ANDA200271 ANI Pharmaceuticals, Inc. HYDROXYPROGESTERONE CAPROATE 250 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 62559-560_1b312ae8-9c0b-40fa-b313-9720d4590748 62559-560 HUMAN PRESCRIPTION DRUG Pindolol Pindolol TABLET ORAL 20170508 ANDA ANDA073608 ANI Pharmaceuticals, Inc. PINDOLOL 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62559-561_1b312ae8-9c0b-40fa-b313-9720d4590748 62559-561 HUMAN PRESCRIPTION DRUG Pindolol Pindolol TABLET ORAL 20170508 ANDA ANDA073609 ANI Pharmaceuticals, Inc. PINDOLOL 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62565-801_157da43c-af27-4169-b867-6437e009db86 62565-801 HUMAN OTC DRUG OneTouch Revolution Topical Anesthetic Benzocaine GEL DENTAL 20170505 OTC MONOGRAPH NOT FINAL part356 HAGER WORLDWIDE, INC. BENZOCAINE 200 mg/g N 20181231 62565-802_3c9448a3-4042-4fb7-96cb-7ecdde045875 62565-802 HUMAN OTC DRUG OneTouch Revolution Topical Anesthetic Benzocaine GEL DENTAL 20170505 OTC MONOGRAPH NOT FINAL part356 HAGER WORLDWIDE, INC. BENZOCAINE 200 mg/g N 20181231 62565-901_e84c6bc3-8bee-4966-a981-8a2d400a9973 62565-901 HUMAN PRESCRIPTION DRUG ONE TOUCH ADVANCED TOPICAL ANESTHETIC GEL COOL MINT BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE GEL DENTAL; TOPICAL 20090201 UNAPPROVED DRUG OTHER HAGER WORLDWIDE, INC. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE 28; 4; 4 mg/.2g; mg/.2g; mg/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 62565-902_69f13372-d95d-4dbc-ae03-ed9a0b49592a 62565-902 HUMAN PRESCRIPTION DRUG ONE TOUCH ADVANCED TOPICAL ANESTHETIC STRAWBERRY ICE BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE GEL DENTAL; TOPICAL 20090201 UNAPPROVED DRUG OTHER HAGER WORLDWIDE, INC. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE 28; 4; 4 mg/.2g; mg/.2g; mg/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 62565-903_b86fa8eb-3daa-4f1d-bbbe-6a87b21f13a9 62565-903 HUMAN PRESCRIPTION DRUG ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE GEL DENTAL; TOPICAL 20090201 UNAPPROVED DRUG OTHER HAGER WORLDWIDE, INC. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE 28; 4; 4 mg/.2g; mg/.2g; mg/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 62565-904_6e3df63a-232a-4b77-bb70-0cd9c0a7ac64 62565-904 HUMAN PRESCRIPTION DRUG ONE TOUCH ADVANCED TOPICAL ANESTHETIC CHERRY BENZOCAINE, BUTAMBEN, TETRACAINE HYDROCHLORIDE GEL DENTAL; TOPICAL 20090201 UNAPPROVED DRUG OTHER HAGER WORLDWIDE, INC. BENZOCAINE; BUTAMBEN; TETRACAINE HYDROCHLORIDE 28; 4; 4 mg/.2g; mg/.2g; mg/.2g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 62566-001_40de5187-edbe-438a-87b2-05bcb0d434b2 62566-001 HUMAN OTC DRUG Venus White Clean Mint Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20120501 OTC MONOGRAPH FINAL part355 Heraeus Kulzer LLC SODIUM FLUORIDE .28 g/113g N 20181231 62569-000_64364a1d-56f7-4555-9cd6-73fecccd1b44 62569-000 HUMAN OTC DRUG Genlabs Strike Bac Antibacterial Handsoap CHLOROXYLENOL SOAP TOPICAL 20130829 OTC MONOGRAPH NOT FINAL part333E Genlabs Corporation CHLOROXYLENOL 2.5 mg/.001L N 20181231 62581-1234_33a45674-f86d-4fbe-bbef-a1ea249c78c5 62581-1234 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19790101 NDA NDA205767 Dubois Medical Supply Company, Inc OXYGEN 99 L/100L N 20181231 62583-001_82433dc0-dabc-4277-8013-d1ebf07dd61f 62583-001 HUMAN OTC DRUG BRONCOLIN Herbal extracts and Honey Menthol LOZENGE ORAL 20140401 OTC MONOGRAPH FINAL part341 BRONCOLIN, S.A. de C.V. MENTHOL 7.5 mg/1 N 20181231 62583-002_fcb879b4-85f2-4785-a801-97ad8fcb766a 62583-002 HUMAN OTC DRUG BRONCOLIN Honey Eucalyptus Menthol LOZENGE ORAL 20150401 OTC MONOGRAPH FINAL part341 BRONCOLIN, S.A. de C.V. MENTHOL 7.5 mg/1 N 20181231 62583-003_28da3c14-2798-5d2f-e054-00144ff88e88 62583-003 HUMAN OTC DRUG Xpecto soothing relief Dextromethorphan HBr Guaifenesin Phenylephrine HCl SYRUP ORAL 20160509 OTC MONOGRAPH FINAL part341 BRONCOLIN, S.A. de C.V. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 200; 10; 20 mg/10mL; mg/10mL; mg/10mL N 20181231 62584-159_5812d5cd-cc5b-1e32-e053-2a91aa0a967c 62584-159 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET ORAL 20101130 ANDA ANDA065425 American Health Packaging DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 62584-163_5812d5cd-cc5b-1e32-e053-2a91aa0a967c 62584-163 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET ORAL 20101215 ANDA ANDA065425 American Health Packaging DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 62584-265_5bbfca01-92ef-c2cf-e053-2991aa0aa57f 62584-265 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100513 ANDA ANDA077739 American Health Packaging METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62584-266_5bbfca01-92ef-c2cf-e053-2991aa0aa57f 62584-266 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100513 ANDA ANDA077739 American Health Packaging METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62584-267_5bbfca01-92ef-c2cf-e053-2991aa0aa57f 62584-267 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20100618 ANDA ANDA077739 American Health Packaging METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62584-467_559d7aba-7aae-6e08-e054-00144ff88e88 62584-467 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20040801 20190531 ANDA ANDA073025 American Health Packaging ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 62584-693_55d9ebf2-914e-1d98-e054-00144ff88e88 62584-693 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline Hyclate TABLET, COATED ORAL 20130301 ANDA ANDA065095 American Health Packaging DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 62584-713_58205d60-c6eb-7eed-e053-2a91aa0ad79c 62584-713 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20040610 NDA NDA018877 American Health Packaging ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 62584-733_58af8964-3482-2139-e053-2991aa0a0624 62584-733 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20080318 ANDA ANDA086242 American Health Packaging HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 62584-734_58af8964-3482-2139-e053-2991aa0a0624 62584-734 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20080318 ANDA ANDA086242 American Health Packaging HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 62584-741_5e3310c6-9def-ac5f-e053-2a91aa0a808e 62584-741 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20101018 ANDA ANDA086183 American Health Packaging HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 62584-812_5ae5a856-e590-480e-e053-2a91aa0a6454 62584-812 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070731 ANDA ANDA072251 American Health Packaging OXAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 62584-813_5ae5a856-e590-480e-e053-2a91aa0a6454 62584-813 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070731 ANDA ANDA072252 American Health Packaging OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 62584-814_5ae5a856-e590-480e-e053-2a91aa0a6454 62584-814 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070808 ANDA ANDA072253 American Health Packaging OXAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 62584-886_559f1dfb-0a31-3827-e054-00144ff88e88 62584-886 HUMAN PRESCRIPTION DRUG TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE TABLET ORAL 20090825 20180331 ANDA ANDA040254 American Health Packaging TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 62584-887_559f1dfb-0a31-3827-e054-00144ff88e88 62584-887 HUMAN PRESCRIPTION DRUG TRIHEXYPHENIDYL HYDROCHLORIDE TRIHEXYPHENIDYL HYDROCHLORIDE TABLET ORAL 20090821 20180228 ANDA ANDA040254 American Health Packaging TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 N 20181231 62584-897_58a00a6e-14b7-220e-e053-2991aa0ab401 62584-897 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20090815 ANDA ANDA040625 American Health Packaging FOLIC ACID 1 mg/1 N 20181231 62584-984_5abb31ee-e18f-2c15-e053-2a91aa0adccf 62584-984 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20040726 ANDA ANDA040301 American Health Packaging WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 62584-988_58205d60-c6eb-7eed-e053-2a91aa0ad79c 62584-988 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20040609 NDA NDA018832 American Health Packaging ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 62584-994_5abb31ee-e18f-2c15-e053-2a91aa0adccf 62584-994 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20040726 ANDA ANDA040301 American Health Packaging WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 62587-219_62609808-7a83-1785-e053-2991aa0aaac3 62587-219 HUMAN OTC DRUG YSNORE DIOSCOREA VILLOSA ROOT, GINGER SPRAY NASAL 20140102 UNAPPROVED HOMEOPATHIC Y Snore DIOSCOREA VILLOSA ROOT; GINGER 2; 2 [hp_X]/mL; [hp_X]/mL N 20191231 62588-804_a6ee4325-1cb8-4727-bdd9-36fb5c265585 62588-804 HUMAN OTC DRUG Earth Baby Soothe N Comfort Diaper Rash Cream Zinc Oxide 10% CREAM TOPICAL 20161201 20190131 OTC MONOGRAPH FINAL part347 Earth Baby, Inc ZINC OXIDE 10 g/100g N 20191231 62588-807_1db44bf1-afea-469b-89bb-9ba9b1a5cb62 62588-807 HUMAN OTC DRUG Earth Baby Sun N Fun Baby Sunscreen SPF 30 Sunscreen CREAM TOPICAL 20161207 20190131 OTC MONOGRAPH FINAL part352 Earth Baby, Inc. TITANIUM DIOXIDE; ZINC OXIDE 5; 3 g/100g; g/100g N 20191231 62592-720_6295e473-526f-1f28-e053-2a91aa0a3a83 62592-720 HUMAN PRESCRIPTION DRUG Ammonul sodium phenylacetate and sodium benzoate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20050217 NDA NDA020645 Ucyclyd Pharma Inc. SODIUM PHENYLACETATE; SODIUM BENZOATE 100; 100 mg/mL; mg/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20191231 62598-001_01a53ef0-7102-4f45-bc47-3345ffcd7b7c 62598-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140217 UNAPPROVED MEDICAL GAS Millennium Medical Supply OXYGEN 99 L/100L E 20171231 62600-100_6b50fb4f-5129-4c83-bfa6-3a4a72ae35ee 62600-100 HUMAN OTC DRUG SECRETIPSS SCALP HAIR ESSENTIAL BOOSTER Allantoin LIQUID TOPICAL 20140201 OTC MONOGRAPH FINAL part347 Innocence, Inc. ALLANTOIN .48 mg/80mL E 20171231 62600-110_85240073-5340-4fbb-9ed8-17560505aac9 62600-110 HUMAN OTC DRUG SECRETIPSS SCALP HAIR ESSENTIAL TONIC PLUS Allantoin LIQUID TOPICAL 20140201 OTC MONOGRAPH FINAL part347 Innocence, Inc. ALLANTOIN .48 mg/80mL E 20171231 62620-1001_4235ae9a-79d6-4f7b-9084-571ebcb5c092 62620-1001 HUMAN OTC DRUG FEDORA Oriental Spa Ampoule GLYCERIN LIQUID TOPICAL 20140306 OTC MONOGRAPH FINAL part347 Fedora International Co., Ltd. GLYCERIN .0798 g/mL E 20171231 62620-2001_cf1f29bb-7469-4217-92da-6a65b8c56f0a 62620-2001 HUMAN OTC DRUG MIRU Oriental Whitening Ampoule GLYCERIN LIQUID TOPICAL 20140306 OTC MONOGRAPH FINAL part347 Fedora International Co., Ltd. GLYCERIN .0224 g/mL E 20171231 62620-3001_1b6f0572-fd51-46d1-9cc3-9becdb9288f6 62620-3001 HUMAN OTC DRUG Fedora Cinderella GLYCERIN CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part347 Fedora International Co., Ltd. GLYCERIN 2 g/100mL E 20171231 62620-4001_8065d8b9-dc6c-48dd-87bd-e76af0fe0255 62620-4001 HUMAN OTC DRUG Fedora CONCENTRATING HYDRO MOISTURIZER GLYCERIN LIQUID TOPICAL 20151026 OTC MONOGRAPH FINAL part347 Fedora International Co., Ltd. GLYCERIN 12 g/100mL E 20171231 62620-5001_6b24fd30-bd26-4dff-bca8-4abd8e7057d3 62620-5001 HUMAN OTC DRUG Fedora CONCENTRATING HYDRO SERUM GLYCERIN LIQUID TOPICAL 20151026 OTC MONOGRAPH FINAL part347 Fedora International Co., Ltd. GLYCERIN .01 g/100mL E 20171231 62620-6001_4e4b7b21-1df6-414b-a794-d5c811179cba 62620-6001 HUMAN OTC DRUG Fedora CONCENTRATING HYDRO TONER GLYCERIN LIQUID TOPICAL 20151026 OTC MONOGRAPH FINAL part347 Fedora International Co., Ltd. GLYCERIN .5 g/100mL E 20171231 62620-7001_681ceb02-30ea-4124-b086-6de9c4bf15a7 62620-7001 HUMAN OTC DRUG Fedora FIRMING INTENSIVE EYE GLYCERIN CREAM TOPICAL 20151026 OTC MONOGRAPH FINAL part347 Fedora International Co., Ltd. GLYCERIN .01 g/100mL E 20171231 62620-8001_f498ab91-1f9e-43e8-9aa9-36942e3de081 62620-8001 HUMAN OTC DRUG Fedora ORIENTAL SPA AMPOULE GLYCERIN LIQUID TOPICAL 20151026 OTC MONOGRAPH FINAL part347 Fedora International Co., Ltd. GLYCERIN 11 g/100mL E 20171231 62622-124_282fb2cb-63fa-4e07-a988-6bd8893d5ebe 62622-124 HUMAN OTC DRUG MiniDrops Lubricant eye drops LIQUID OPHTHALMIC 19910401 OTC MONOGRAPH FINAL part349 Taiwan Biotech Co, Ltd POVIDONE K30; POLYVINYL ALCOHOL .6; 1.4 mL/100mL; mL/100mL N 20181231 62630-001_ec04d15a-a953-4c26-b5ab-743ec1e06aa6 62630-001 HUMAN OTC DRUG PREQUIMM Veratrum Album, Colchicum Autumnale, Conium Maculatum, Ipecacuanha, Nux Vomica, Argentum Nitricum, Pulsatilla Pratensis TABLET, ORALLY DISINTEGRATING ORAL 20140501 UNAPPROVED HOMEOPATHIC ZRG DETOX, INC. VERATRUM ALBUM ROOT; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; IPECAC; STRYCHNOS NUX-VOMICA SEED; SILVER NITRATE; PULSATILLA PRATENSIS 3; 4; 4; 4; 4; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62638-001_f99559d5-ef40-485e-821f-a17db6c061fe 62638-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140305 UNAPPROVED MEDICAL GAS Home Medical Equipment Specialists, LLC OXYGEN 99 L/100L E 20171231 62646-791_1b36f09f-c2cc-429a-859e-a673fc50ad1b 62646-791 HUMAN PRESCRIPTION DRUG Sterile Cord Blood Collection Unit Cord Blood Collection Unit SOLUTION INTRAVENOUS 20110316 NDA NDA800222 Medsep Corporation SODIUM CITRATE; DEXTROSE MONOHYDRATE; CITRIC ACID; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .921; .893; .114; .078 g/35mL; g/35mL; g/35mL; g/35mL E 20171231 62646-798_a083fb8e-3012-4d12-94d3-949a3188aba3 62646-798 HUMAN PRESCRIPTION DRUG Anticoagulant Sodium Citrate Sodium Citrate SOLUTION INTRAVENOUS 20110415 NDA NDA760305 Medsep Corporation SODIUM CITRATE 10 g/250mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] E 20171231 62651-001_41d1819c-4942-5be4-e054-00144ff8d46c 62651-001 HUMAN OTC DRUG Unscented Hand Sanitizer ALCOHOL GEL TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part333E Base4 Ventures LLC ALCOHOL 62 mL/100mL N 20181231 62651-002_41d1b989-f0fd-3807-e054-00144ff88e88 62651-002 HUMAN OTC DRUG Vanilla Hand Sanitizer ALCOHOL GEL TOPICAL 20140224 OTC MONOGRAPH NOT FINAL part333E Base4 Ventures LLC ALCOHOL 62 mL/100mL N 20181231 62651-003_41d19eb4-d415-5878-e054-00144ff8d46c 62651-003 HUMAN OTC DRUG Very Vanilla Antibacterial ETHYL ALCOHOL SPRAY TOPICAL 20150622 OTC MONOGRAPH NOT FINAL part333E Base4 Ventures LLC ALCOHOL 620 mg/mL N 20181231 62651-004_41d1819c-4975-5be4-e054-00144ff8d46c 62651-004 HUMAN OTC DRUG holiday cookie antibacterial ETHYL ALCOHOL SPRAY TOPICAL 20150622 OTC MONOGRAPH NOT FINAL part333E Base4 Ventures LLC ALCOHOL 620 mg/mL N 20181231 62651-005_41d171d2-1ecc-52de-e054-00144ff8d46c 62651-005 HUMAN OTC DRUG Pretty Peppermint Antibacterial ETHYL ALCOHOL SPRAY TOPICAL 20150622 OTC MONOGRAPH NOT FINAL part333E Base4 Ventures LLC ALCOHOL 620 mg/mL N 20181231 62654-140_5d18eae6-ed3c-4c14-81c6-53fcb7ae41f1 62654-140 HUMAN OTC DRUG DermaCen Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part333A Central Solutions Inc ALCOHOL 64.5 mL/100mL N 20181231 62654-141_f898f5c3-a4b1-427a-ae7d-7ab383d747e8 62654-141 HUMAN OTC DRUG DermaCen Non-Alcohol Foaming Hand Sanitizer Benzalkonium Chloride SOLUTION TOPICAL 20100118 OTC MONOGRAPH NOT FINAL part333A Central Solutions Inc BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 62654-142_1b2fbf7f-c4de-4219-ad7e-0d45de4d7840 62654-142 HUMAN OTC DRUG BOA VIDA Recovery Creme DIMETHICONE CREAM TOPICAL 20110601 OTC MONOGRAPH FINAL part347 Central Solutions Inc DIMETHICONE 1.5 g/100mL N 20181231 62654-143_c6979d7b-4822-4a78-bbd7-74ece8efc602 62654-143 HUMAN OTC DRUG DermaCen Instant Hand Sanitizer with Aloe Alcohol LIQUID TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part333A Central Solutions Inc ALCOHOL 64.5 mL/100mL N 20181231 62654-144_f43a0dc2-3c0e-42ca-86dc-2d4f3907814a 62654-144 HUMAN OTC DRUG BOA VIDA Canopy DIMETHICONE CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 Central Solutions Inc DIMETHICONE 2 g/100mL N 20181231 62654-145_5fb61bd0-0bcd-4f57-a7a8-d95daa2bbb4c 62654-145 HUMAN OTC DRUG BOA VIDA Calvida ZINC OXIDE CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 Central Solutions Inc ZINC OXIDE 20 g/100mL N 20181231 62654-146_9f1f2afe-a0f3-4a3b-a564-ca5805604b27 62654-146 HUMAN OTC DRUG BOA VIDA Cleansing DIMETHICONE CREAM TOPICAL 20111101 OTC MONOGRAPH FINAL part347 Central Solutions Inc DIMETHICONE 1.5 mL/100mL N 20181231 62654-230_c89af290-d270-4c99-98f5-238adfc036fc 62654-230 HUMAN OTC DRUG DermaCen Antimicrobial-T Hand Triclosan LIQUID TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part333A Central Solutions Inc TRICLOSAN .375 mL/100mL N 20181231 62654-231_d7ff3380-7017-428b-b891-bb0eb35570b2 62654-231 HUMAN OTC DRUG DermaCen Antimicrobial-P Hand CHLOROXYLENOL LIQUID TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part333A Central Solutions Inc CHLOROXYLENOL .95 mL/100mL N 20181231 62654-239_6c53b5e6-fcb5-4f89-8f37-648aeed29f03 62654-239 HUMAN OTC DRUG DermaCen Foaming Antimicrobial-T Hand Triclosan LIQUID TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333A Central Solutions Inc TRICLOSAN .375 mL/100mL N 20181231 62654-313_96284017-7865-456a-a6c8-24d53fe6b013 62654-313 HUMAN OTC DRUG DermaCen Protectant Zinc oxide CREAM TOPICAL 20010101 OTC MONOGRAPH FINAL part346 Central Solutions Inc ZINC OXIDE 5 g/100g N 20181231 62670-3635_368351d9-5b20-44da-87d9-63ff4e71f9cf 62670-3635 HUMAN OTC DRUG Anti-Bacterial Hand Dancing Waters ALCOHOL GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-3640_7958ccc9-3586-479d-84b2-ba1e26fa6196 62670-3640 HUMAN OTC DRUG Anti-Bacterial Hand Sweet Pea ALCOHOL GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-3643_6f2ed26c-6478-496d-bb32-7994df3e3e7b 62670-3643 HUMAN OTC DRUG Anti-Bacterial Hand Warm Vanilla Sugar ALCOHOL GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-3756_1e4a5a05-e8b8-40ae-b4b0-200f30dd691b 62670-3756 HUMAN OTC DRUG Anti-Bacterial Hand Spray Sweet Pea ALCOHOL LIQUID TOPICAL 20101221 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 72 mL/100mL E 20171231 62670-3757_d4e8ba6d-675f-4ee7-9af4-07ef56aec2bd 62670-3757 HUMAN OTC DRUG Anti-Bacterial Hand Spray Warm Vanilla Sugar ALCOHOL LIQUID TOPICAL 20101221 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 72 mL/100mL E 20171231 62670-4078_bd7175db-b06e-44b7-8f26-660eac588a81 62670-4078 HUMAN OTC DRUG Anti-Bacterial Hand Lemon Alcohol GEL TOPICAL 20110728 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-4114_fbed1660-25ae-4e98-9aee-370f6b91ac4d 62670-4114 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Market Apple ALCOHOL LIQUID TOPICAL 20110822 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 72 mL/100mL E 20171231 62670-4164_c7efd32d-889d-45bf-93fe-3c522cb828c1 62670-4164 HUMAN OTC DRUG Anti-Bacterial Moisturizing Hand Pumpkin Caramel Latte Triclosan SOAP TOPICAL 20120403 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. TRICLOSAN 3 mg/g E 20171231 62670-4366_88d0c9e8-438b-42e5-a5b0-276328cb57a7 62670-4366 HUMAN OTC DRUG Anti-Bacterial Hand Japanese Cherry Blossom ALCOHOL SPRAY TOPICAL 20130611 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 72 mL/100mL E 20171231 62670-4562_18d03c27-6cda-4a3f-a39b-f7e993514676 62670-4562 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Japanese Cherry Blossom Alcohol GEL TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-4563_68f72875-5609-4006-bd14-a45f8af6e890 62670-4563 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Sugar Lemon Fizz Alcohol GEL TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-4564_245cff5b-e7b6-446b-9d32-b3680f7eebdb 62670-4564 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Summer Escape Alcohol GEL TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-4565_0834044d-3d4d-45c2-adec-5955bb398ebb 62670-4565 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Sweet Pea Alcohol GEL TOPICAL 20130515 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-4569_c57bf4c2-c4c3-45b6-8a0e-067704764347 62670-4569 HUMAN OTC DRUG Anti-Bacterial Hand Coconut Lime Verbena ALCOHOL SPRAY TOPICAL 20130604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 72 mL/100mL E 20171231 62670-4600_1827eb2f-65ec-4476-bcc4-c444b9dc9daf 62670-4600 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Fresh Strawberries Alcohol GEL TOPICAL 20130726 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-4780_f129d669-26b9-4800-8163-bde2b337d4a9 62670-4780 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Eucalyptus Spearmint Alcohol GEL TOPICAL 20140404 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-4908_1a0d1d03-d712-421e-8dea-736c11fbe35f 62670-4908 HUMAN OTC DRUG Anti-Bacterial Hand Aromatherapy Stress Relief Eucalyptus Spearmint Alcohol GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-4913_e258f288-129e-4be1-add0-8fb52f1569e0 62670-4913 HUMAN OTC DRUG Anti-Bacterial Hand Ocean For Men Alcohol GEL TOPICAL 20121206 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-4915_404eee04-fa79-4c5d-be16-d0830767a7bb 62670-4915 HUMAN OTC DRUG Anti-Bacterial Hand Japanese Cherry Blossom Alcohol GEL TOPICAL 20150610 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-4948_3426d5bd-a334-4665-b35f-271721a4f186 62670-4948 HUMAN OTC DRUG Anti-Bacterial Hand Black Cherry Merlot Alcohol GEL TOPICAL 20150804 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-5003_89a52af9-5dd8-46ad-ac90-a879b4c7aa4b 62670-5003 HUMAN OTC DRUG Anti-Bacterial Hand A Thousand Wishes Alcohol GEL TOPICAL 20151231 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-5022_9e89f190-47e3-41d9-86bb-6a62d2c78110 62670-5022 HUMAN OTC DRUG Anti-Bacterial Hand Sweet Pea ALCOHOL SPRAY TOPICAL 20160105 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 72 mL/100mL E 20171231 62670-5023_87c57a3b-8ce6-4b65-952d-cfa2334c9ca0 62670-5023 HUMAN OTC DRUG Anti-Bacterial Hand Warm Vanilla Sugar ALCOHOL SPRAY TOPICAL 20160105 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 72 mL/100mL E 20171231 62670-5024_3ec756ac-4d25-4959-9fde-cf6378a643aa 62670-5024 HUMAN OTC DRUG Anti-Bacterial Hand Beautiful Day Alcohol GEL TOPICAL 20160105 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-5025_42b6e2ac-7224-4064-885b-44bcbf2b2340 62670-5025 HUMAN OTC DRUG Anti-Bacterial Hand Japanese Cherry Blossom Alcohol GEL TOPICAL 20160105 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-5062_f74b5ee6-a4db-4212-8535-2d21c769026f 62670-5062 HUMAN OTC DRUG Anti-Bacterial Hand Sweet Pea Alcohol GEL TOPICAL 20160602 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-5138_31d84485-a891-4cc8-93ab-3ed5b7f8633a 62670-5138 HUMAN OTC DRUG Anti-Bacterial Hand A Thousand Wishes Alcohol GEL TOPICAL 20161021 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL E 20171231 62670-5169_76066bef-cadf-487b-bcf5-767563527a63 62670-5169 HUMAN OTC DRUG Anti-Bacterial Hand Hello Beautiful Alcohol GEL TOPICAL 20161019 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5252_5af8a9c0-2757-4248-97e2-41daffaec31f 62670-5252 HUMAN OTC DRUG Anti-Bacterial Hand Bergamot Mandarin Alcohol GEL TOPICAL 20171120 20180520 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5253_1cfe8ff3-2e71-401c-8d1e-dbd64e11326c 62670-5253 HUMAN OTC DRUG Anti-Bacterial Hand Eucalyptus Spearmint ALCOHOL GEL TOPICAL 20171120 20180520 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5254_9ca5feae-4c94-4317-9159-3b0e114e2935 62670-5254 HUMAN OTC DRUG Anti-Bacterial Hand Eucalyptus Tea ALCOHOL GEL TOPICAL 20171120 20180520 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5255_4bd2341d-3a0e-442f-b714-0f40e0cb00ad 62670-5255 HUMAN OTC DRUG Anti-Bacterial Hand Lavender Cedarwood ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5256_21c24c7c-6945-4055-bf61-d4f0285349ff 62670-5256 HUMAN OTC DRUG Anti-Bacterial Hand Vanilla Patchouli ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5257_b7d9db2e-f03a-4113-bdc5-7db3b3075ccb 62670-5257 HUMAN OTC DRUG Anti-Bacterial Hand Orange Ginger ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5258_292827ce-0c19-41ca-bc18-b2a3572bf002 62670-5258 HUMAN OTC DRUG Anti-Bacterial Hand Dancing Waters ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5259_dd907a71-fc29-463c-ab60-95dde45a3c6c 62670-5259 HUMAN OTC DRUG Anti-Bacterial Hand Lit ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5261_da0b9f5b-225c-410f-bfdc-284828e83c54 62670-5261 HUMAN OTC DRUG Anti-Bacterial Hand Savage ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5262_8834c10d-114c-45e8-9da2-606ea2eedf35 62670-5262 HUMAN OTC DRUG Anti-Bacterial Hand Unicorn Water ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5263_41b3baee-696e-4c06-84b7-ee27b43f20c1 62670-5263 HUMAN OTC DRUG Anti-Bacterial Hand Better Have My Candy ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5264_16c9df05-be03-48c6-982c-496b8d86757a 62670-5264 HUMAN OTC DRUG Anti-Bacterial Hand Ghoul Friend ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5265_3f7fb0f2-38cd-4a74-8c00-cfc14af7ec6a 62670-5265 HUMAN OTC DRUG Anti-Bacterial Hand Not Your Boo ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5266_a47bf555-fdce-4f87-8234-79cef2887d1d 62670-5266 HUMAN OTC DRUG Anti-Bacterial Hand purrfect pumpkin ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5267_6788944f-f9e5-4501-bc9c-175a558c2127 62670-5267 HUMAN OTC DRUG Anti-Bacterial Hand Spooktacular ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5268_fe66e134-228e-4577-b6fb-6e8c42d99236 62670-5268 HUMAN OTC DRUG Anti-Bacterial Hand Vampire Blood ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5269_afebe67e-1e3a-4f3c-b50f-23d6bb0c92bc 62670-5269 HUMAN OTC DRUG Anti-Bacterial Hand Japanese Cherry Blossom ALCOHOL GEL TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5271_d5e077c2-a039-445a-930a-81b1e72e8073 62670-5271 HUMAN OTC DRUG Anti-Bacterial Hand Bali ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5272_9af1818e-8d98-4261-84de-900991ecef4e 62670-5272 HUMAN OTC DRUG Anti-Bacterial Hand Dancing Waters ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5273_9c197e16-4fc4-499b-918a-091314c41970 62670-5273 HUMAN OTC DRUG Anti-Bacterial Hand Fiji ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5274_11effe33-6edb-456e-8f65-ac380dd665e7 62670-5274 HUMAN OTC DRUG Anti-Bacterial Hand Fresh Sparkling Snow ALCOHOL GEL TOPICAL 20171121 20180521 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5276_963c3595-0079-4527-9078-61f5c9e0eee8 62670-5276 HUMAN OTC DRUG Anti-Bacterial Hand Good Vibes Only ALCOHOL GEL TOPICAL 20171122 20180522 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5277_a04975b5-f74d-4108-9969-50e4f8cbb078 62670-5277 HUMAN OTC DRUG Anti-Bacterial Hand Hello Beautiful ALCOHOL GEL TOPICAL 20171122 20180522 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5278_9bab34cd-cb9c-4c45-a5d3-7d34fda7c08f 62670-5278 HUMAN OTC DRUG Anti-Bacterial Hand Maui ALCOHOL GEL TOPICAL 20171122 20180522 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5279_8e6a3f7d-6b59-4eb9-a0c0-5de2508a4479 62670-5279 HUMAN OTC DRUG Anti-Bacterial Hand Melon Forever ALCOHOL GEL TOPICAL 20171124 20180524 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5280_17e1a6d4-f0c0-4af9-b63a-20488ff31f20 62670-5280 HUMAN OTC DRUG Anti-Bacterial Hand Pretty As A Peach ALCOHOL GEL TOPICAL 20171124 20180524 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5281_0582458e-9974-444f-9fb5-e87808e1f9a4 62670-5281 HUMAN OTC DRUG Anti-Bacterial Hand Pretty Pink Peony ALCOHOL GEL TOPICAL 20171124 20180524 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5282_8ff03732-e134-4c22-8d84-6f240f5f36fd 62670-5282 HUMAN OTC DRUG Anti-Bacterial Hand Sweet As Strawberries ALCOHOL GEL TOPICAL 20171124 20180524 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5283_771329bf-27fc-4bd2-8ded-4feb2f780c6d 62670-5283 HUMAN OTC DRUG Anti-Bacterial Hand Winter White Woods ALCOHOL GEL TOPICAL 20171124 20180524 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5284_4d69d895-cfa9-4487-8290-ad22009f8b91 62670-5284 HUMAN OTC DRUG Anti-Bacterial Hand You Are My Sunshine ALCOHOL GEL TOPICAL 20171124 20180524 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5285_9d945905-a43c-41da-9caa-6e14709f09f7 62670-5285 HUMAN OTC DRUG Anti-Bacterial Hand Afternoon Apple Picking ALCOHOL GEL TOPICAL 20171124 20180524 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5286_acaedf7d-a781-4890-9595-3a8d93da7806 62670-5286 HUMAN OTC DRUG Anti-Bacterial Hand Crisp Morning Air ALCOHOL GEL TOPICAL 20171124 20180524 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5288_cfb28c9f-c764-4f8f-a878-4f4eae59323d 62670-5288 HUMAN OTC DRUG Anti-Bacterial Hand Sweet Cinnamon Pumpkin ALCOHOL GEL TOPICAL 20171124 20180524 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5289_89344538-4597-4151-ad16-c78938e0026a 62670-5289 HUMAN OTC DRUG Anti-Bacterial Hand Bourbon ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5290_48b062dc-a4a0-434f-a10a-1ba918cac26f 62670-5290 HUMAN OTC DRUG Anti-Bacterial Hand Bee You ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5291_606e648b-e7f9-4ccc-8f08-93b0f941e557 62670-5291 HUMAN OTC DRUG Anti-Bacterial Hand Hands Off My Honey ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5292_09162d25-06cf-43f7-ae9e-d593416a3019 62670-5292 HUMAN OTC DRUG Anti-Bacterial Hand Snow Kissed Citrus ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5293_06e7adc9-15ac-411c-bba4-241aab390d89 62670-5293 HUMAN OTC DRUG Anti-Bacterial Hand Marshmallow Fireside ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5294_ed331c21-17b0-44c2-b3fe-031743fc19ef 62670-5294 HUMAN OTC DRUG Anti-Bacterial Hand A Thousand Wishes ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5295_4eefc7c3-e36f-4e96-9643-8de772c58aeb 62670-5295 HUMAN OTC DRUG Anti-Bacterial Hand Beautiful Day ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5296_dfbc0a17-5ca3-4cc2-b807-eb98ceeb7fab 62670-5296 HUMAN OTC DRUG Anti-Bacterial Hand Black Cherry Merlot ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5297_60e773a6-9bfa-4b85-b3fd-8073e04c14b6 62670-5297 HUMAN OTC DRUG Anti-Bacterial Hand French Lavendar ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5298_9c639647-7a30-41f4-81c0-a0976574d2e2 62670-5298 HUMAN OTC DRUG Anti-Bacterial Hand Peach Bellini ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5299_af16bd7c-ffb9-4c23-bb5a-98166b7c0c99 62670-5299 HUMAN OTC DRUG Anti-Bacterial Hand Sweet Pea ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5300_6dd95042-ec14-4197-ba26-a4ee8058064a 62670-5300 HUMAN OTC DRUG Anti-Bacterial Hand Chamomile ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5301_426c2277-4f1f-454c-9bc2-8c417f50bdc8 62670-5301 HUMAN OTC DRUG Anti-Bacterial Hand Citrus ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5302_7478b8c8-f4f8-4234-8539-628d7adffc2b 62670-5302 HUMAN OTC DRUG Anti-Bacterial Hand Coconut ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5303_0e967417-4020-4922-914d-1da5c762feaf 62670-5303 HUMAN OTC DRUG Anti-Bacterial Hand Cucumber ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5304_66321aca-196e-4c87-a851-8f4d21c060c5 62670-5304 HUMAN OTC DRUG Anti-Bacterial Hand Iced Gingerbread ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5305_1468c4fd-a5a1-458e-909f-296e2b826cd5 62670-5305 HUMAN OTC DRUG Anti-Bacterial Hand Twisted Peppermint ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5306_2a6776e0-d35c-42d9-8c37-e3f6581c4c87 62670-5306 HUMAN OTC DRUG Anti-Bacterial Hand Vanilla Bean Noel ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5307_7f1bef93-3567-46c3-a10b-c7bfa2bdd34d 62670-5307 HUMAN OTC DRUG Anti-Bacterial Hand Winter Candy Apple ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5308_2c215371-6904-4753-ae77-2fdb910013fa 62670-5308 HUMAN OTC DRUG Anti-Bacterial Hand Black Chamomile ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5309_178e10eb-b46f-46d6-87b6-d7f5af96f058 62670-5309 HUMAN OTC DRUG Anti-Bacterial Hand Lemon Zest ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5310_d6c6f25b-8549-48f3-87fa-0be5397b3a08 62670-5310 HUMAN OTC DRUG Anti-Bacterial Hand Free Spirit ALCOHOL GEL TOPICAL 20171127 20180527 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5311_0a935bf3-6496-471e-8771-b019b561141b 62670-5311 HUMAN OTC DRUG Anti-Bacterial Hand A Unicorn Ate My Homework ALCOHOL GEL TOPICAL 20171128 20180528 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5312_2474789b-5c01-4760-af07-495c50d1a5ae 62670-5312 HUMAN OTC DRUG Anti-Bacterial Hand Bougie ALCOHOL GEL TOPICAL 20171128 20180528 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5313_35cfbce9-65be-4e6f-bd7d-a6ccad4279ce 62670-5313 HUMAN OTC DRUG Anti-Bacterial Hand But First Champagne ALCOHOL GEL TOPICAL 20171128 20180528 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5314_3f84af1e-5cb6-4157-b578-61a44c47e537 62670-5314 HUMAN OTC DRUG Anti-Bacterial Hand Dont Quit Your Daydream ALCOHOL GEL TOPICAL 20171128 20180528 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5315_4fd9e35e-47ef-4cdd-a5ff-a6a5c25bc06e 62670-5315 HUMAN OTC DRUG Anti-Bacterial Hand Read My Lips ALCOHOL GEL TOPICAL 20171128 20180528 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5316_faed6bef-f0eb-4709-8076-f49e9f29a6c3 62670-5316 HUMAN OTC DRUG Anti-Bacterial Hand So Fresh And So Clean ALCOHOL GEL TOPICAL 20171128 20180528 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5317_0ce1578e-b079-45d1-b93f-2fd3d0161c64 62670-5317 HUMAN OTC DRUG Anti-Bacterial Hand Coffee Is My Spirit Animal ALCOHOL GEL TOPICAL 20171128 20180528 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5318_ea414173-6236-4c04-8af0-b17e0ea92715 62670-5318 HUMAN OTC DRUG Anti-Bacterial Hand Mermaids Are My Spirit Animal ALCOHOL GEL TOPICAL 20171128 20180528 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5319_cc4eea18-20ae-4ca3-b536-51deb206b4d9 62670-5319 HUMAN OTC DRUG Anti-Bacterial Hand My Dog Is My Spirit Animal ALCOHOL GEL TOPICAL 20171128 20180528 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5321_14d8a009-1cae-4853-944b-4b22746bed73 62670-5321 HUMAN OTC DRUG Anti-Bacterial Hand Unicorns Are My Spirit Animal ALCOHOL GEL TOPICAL 20171128 20180528 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5322_97a5329a-e9ac-401c-bb8a-2b25e76ee9f3 62670-5322 HUMAN OTC DRUG Anti-Bacterial Hand Believe ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5323_e119315b-afa4-4c06-b751-d2a4b8ee3608 62670-5323 HUMAN OTC DRUG Anti-Bacterial Hand Gnome For The Holidays ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5324_5a18baaf-90d9-4a78-882a-25fe784fdf1e 62670-5324 HUMAN OTC DRUG Anti-Bacterial Hand Make It Rein ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5325_0a86878e-88c3-4b07-a49f-a52441b7da4b 62670-5325 HUMAN OTC DRUG Anti-Bacterial Hand Son Of A Nutcracker ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5326_cca21474-7783-43be-8edb-d849f1a630b0 62670-5326 HUMAN OTC DRUG Anti-Bacterial Hand The Snuggle Is Real ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5327_a5d43185-1d63-4c6e-95b5-3c231bd348bb 62670-5327 HUMAN OTC DRUG Anti-Bacterial Hand Throw Kindness Like Confetti ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5329_690e98a6-3d59-4bd3-a5ab-80ee9d776b05 62670-5329 HUMAN OTC DRUG Anti-Bacterial Hand Spread Sparkle ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5330_96dff49b-9761-4833-bfb7-8302032890c4 62670-5330 HUMAN OTC DRUG Anti-Bacterial Hand Bae Watch ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5331_21b732c6-3cfc-4b36-8602-9375e33777d3 62670-5331 HUMAN OTC DRUG Anti-Bacterial Hand Goal Digger ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5332_d466e3bf-263a-4a2b-9881-08ece0bf894a 62670-5332 HUMAN OTC DRUG Anti-Bacterial Hand No Shade ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5333_a8e4f3fa-4ce4-4089-adea-35b8c5d965d2 62670-5333 HUMAN OTC DRUG Anti-Bacterial Hand The Thirst Is Real ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5334_9c4964ae-6790-480f-902d-04bdcb47e457 62670-5334 HUMAN OTC DRUG Anti-Bacterial Hand Poolside Pop ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5335_5f9dbaf5-3b30-4b5d-a27b-bc472dfdc0fd 62670-5335 HUMAN OTC DRUG Anti-Bacterial Hand Bee Happy ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5336_a4fc9e9e-e9fb-46e7-b4ca-c8a794626441 62670-5336 HUMAN OTC DRUG Anti-Bacterial Hand Green Tea ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5337_6b175823-b2d7-4a21-af12-6b3f951d789d 62670-5337 HUMAN OTC DRUG Anti-Bacterial Hand Sorry Im Latte ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5338_a8eb8a90-ef03-4ac3-9cfc-bb92bac35c05 62670-5338 HUMAN OTC DRUG Anti-Bacterial Hand Be Fab Everyday ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5339_69d6e2d7-6818-428c-ad63-362676e36eee 62670-5339 HUMAN OTC DRUG Anti-Bacterial Hand Best Day Ever ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5340_46b27957-2671-48cc-8f3f-7d0e7717fce6 62670-5340 HUMAN OTC DRUG Anti-Bacterial Hand Happy Birthday ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5341_546c1cd8-5474-4546-af12-532ddaecfe0c 62670-5341 HUMAN OTC DRUG Anti-Bacterial Hand Yay ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5342_96e3c861-f9ae-4454-b1e9-80570f0801a9 62670-5342 HUMAN OTC DRUG Anti-Bacterial Hand Youre Killing It ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5343_bfb57bd4-2bda-422e-9e32-1e4e591db38a 62670-5343 HUMAN OTC DRUG Anti-Bacterial Hand Congrats ALCOHOL GEL TOPICAL 20171129 20180529 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5344_3e6919b9-6506-4956-99e2-8f259e80b747 62670-5344 HUMAN OTC DRUG Anti-Bacterial Hand Imagine Believe Achieve ALCOHOL GEL TOPICAL 20171130 20180530 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5345_cca171b7-fbad-4a06-97dc-13d03a1b9178 62670-5345 HUMAN OTC DRUG Anti-Bacterial Hand Running Late Is My Cardio ALCOHOL GEL TOPICAL 20171130 20180530 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5346_b01acc06-a908-490c-a8e2-9818b0beeef2 62670-5346 HUMAN OTC DRUG Anti-Bacterial Hand Yoga Babe ALCOHOL GEL TOPICAL 20171130 20180530 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5347_5bc0a50b-d6df-4b9a-8bff-917bc4fa0776 62670-5347 HUMAN OTC DRUG Anti-Bacterial Hand Best Teacher Ever ALCOHOL GEL TOPICAL 20171130 20180530 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5348_8ac72106-e665-4839-ab40-191ac4a154ae 62670-5348 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer I Cant Adult Today Alcohol GEL TOPICAL 20171206 20180606 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5349_24133cb2-fad6-40e4-b05a-c653f8d229a2 62670-5349 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Black Cherry Merlot Alcohol GEL TOPICAL 20171130 20180530 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5350_4f8650e3-971b-405b-a497-07cf12923e58 62670-5350 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer But First Coffee Alcohol GEL TOPICAL 20171130 20180530 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5351_96c6e1f9-364e-441e-bf5c-0f17227bf24b 62670-5351 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Days Until Summer Alcohol GEL TOPICAL 20171130 20180530 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5352_7c05be53-1966-4498-8212-8cd8974c1bc3 62670-5352 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Eucalyptus Spearmint Alcohol GEL TOPICAL 20171130 20180530 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5353_b01d2dbf-4339-42a1-bedd-bc8bcae5e3e2 62670-5353 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Good Vibes Only Alcohol GEL TOPICAL 20171130 20180530 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5354_4b3149eb-81ec-4d7d-857a-967f00f51443 62670-5354 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Japanese Cherry Blossom Alcohol GEL TOPICAL 20171130 20180530 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5355_735ddebc-7963-4500-a498-d867eac05def 62670-5355 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Leave A Little Sparkle Alcohol GEL TOPICAL 20171201 20180601 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5356_8c4b8227-3062-4840-8e3b-86e5eae9c2b7 62670-5356 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Mens Ocean Alcohol GEL TOPICAL 20171201 20180601 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5357_8ab68577-c67f-48dd-937e-0fcab00f5abc 62670-5357 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Peach Bellini Alcohol GEL TOPICAL 20171201 20180601 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5358_21472323-f2b8-41af-9045-7341575ef474 62670-5358 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Sunshine and Lemons Alcohol GEL TOPICAL 20171201 20180601 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5359_21a37ad5-5c47-4063-8796-ef1b71695dd1 62670-5359 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Dont Make Me Use My Teacher Voice Alcohol GEL TOPICAL 20171201 20180601 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5360_c68f5965-83ad-4f4f-b8c9-67c5418253ec 62670-5360 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Toasted Coconut Alcohol GEL TOPICAL 20171201 20180601 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5361_abd68cba-b0bc-497f-b5d4-0894867d77d2 62670-5361 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer Watermelon Lemonade Alcohol GEL TOPICAL 20171201 20180601 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5362_cbd425f8-5fb0-47eb-8b6d-7fc69b788f58 62670-5362 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer White Driftwood Alcohol GEL TOPICAL 20171201 20180601 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5368_1f87ea2d-7275-4119-a3e6-f9c6534e7c0e 62670-5368 HUMAN OTC DRUG Anti-Bacterial Hand Ho Ho Oh ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5369_e13a0da8-78a9-475c-8ba9-426824365b5b 62670-5369 HUMAN OTC DRUG Anti-Bacterial Hand Nice ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5370_fbabb324-1fcf-47e9-8b37-7890f1040475 62670-5370 HUMAN OTC DRUG Anti-Bacterial Hand Resting Grinch Face ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5371_9836b105-b1a4-48c9-a5f6-e5a827bb3c88 62670-5371 HUMAN OTC DRUG Anti-Bacterial Hand Merry And Bright ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5372_120470b3-a173-4547-b2f3-64ab8ee94a5a 62670-5372 HUMAN OTC DRUG Anti-Bacterial Hand Marshmallow Pumpkin Latte ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5373_c4361911-461c-48c9-a8a4-985a741b9c6b 62670-5373 HUMAN OTC DRUG Anti-Bacterial Hand Santa Slay ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5374_e585d522-4d56-4fbb-af64-d095ef5719fa 62670-5374 HUMAN OTC DRUG Anti-Bacterial Hand Warm Vanilla Sugar ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5375_2c033a6c-8340-41cd-81bc-2705517ae412 62670-5375 HUMAN OTC DRUG Anti-Bacterial Hand Sparkling Mint Blossom ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5376_7d9ba3fe-9141-4860-8cbe-0bea84faef1c 62670-5376 HUMAN OTC DRUG Anti-Bacterial Hand Lemon Woods ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5377_6af2b196-db0e-480d-97d5-8aa2f4c1eb2c 62670-5377 HUMAN OTC DRUG Anti-Bacterial Hand Lime Basil ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5378_fe23cd87-f3d1-4136-8f11-587d982da8f3 62670-5378 HUMAN OTC DRUG Anti-Bacterial Hand Vanilla Peppermint ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5379_bd7474b3-ff57-413d-aaff-df129f5bda34 62670-5379 HUMAN OTC DRUG Anti-Bacterial Hand White Tea ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-5380_611c16c7-2999-4a10-9363-384c4ea3c0fa 62670-5380 HUMAN OTC DRUG Anti-Bacterial Hand Fragrance Free ALCOHOL GEL TOPICAL 20171204 20180604 OTC MONOGRAPH NOT FINAL part333E Bath & Body Works, Inc. ALCOHOL 68 mL/100mL N 20181231 62670-8042_8bb76fcf-5169-4c22-a045-5779da91b7aa 62670-8042 HUMAN OTC DRUG Patricia Wexler Skin Brightening Daily Moisturizer with Sunscreen Broad Spectrum SPF 28 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130828 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 1.8; 7.5; 5; 2.4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 62670-8043_14af5e69-d00b-411b-8274-df6eab3a49c3 62670-8043 HUMAN OTC DRUG Patricia Wexler Universal Anti-Aging Moisturizer with Sunscreen Broad Spectrum SPF 28 Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130828 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 1.8; 7.5; 5; 2.4 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 62670-8045_e11ecd4c-2f66-4d34-afd0-cd858cbc1376 62670-8045 HUMAN OTC DRUG Signature Sunscreen Broad Spectrum SPF 25 Malibu Heat Avobenzone, Octinoxate, Oxybenzone LOTION TOPICAL 20130909 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 3; 7.5; 6 g/100mL; g/100mL; g/100mL E 20171231 62670-8046_90ac3b6a-ce75-4a98-9d31-7a706b7572ad 62670-8046 HUMAN OTC DRUG True Blue Spa Cooling Sunscreen Mist Broad Spectrum SPF 25 Water Resistant (40 minutes) Monoi Oil Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20130930 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13.5; 7.5; 4.6; 2.4; 6 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 62670-8047_d855965d-f5bf-4334-99a1-2c6025dd7fb0 62670-8047 HUMAN OTC DRUG Patricia Wexler Intensive 3-in-1 Day Cream with Sunscreen Broad Spectrum SPF 28 Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20130930 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.7; 4 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 62670-8048_f2a501e9-613c-4842-86d6-11ab04ec4e39 62670-8048 HUMAN OTC DRUG Victorias Secret Sun Broad Spectrum SPF 25 Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13.5; 7.5; 4.6; 2.4; 6 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 62670-8049_447b754f-f792-4e32-846d-9f57f473563a 62670-8049 HUMAN OTC DRUG Victorias Secret Pink Broad Spectrum SPF 25 Sunscreen Sunkissed Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20160411 OTC MONOGRAPH NOT FINAL part352 Bath & Body Works, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13.5; 7.5; 4.6; 2.4; 6 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 62672-221_ba9856d4-dece-4ee7-b350-3d9d140eede3 62672-221 HUMAN OTC DRUG Tampa General Hospital Instant Hand Degermer ALCOHOL GEL TOPICAL 20061101 OTC MONOGRAPH NOT FINAL part333 Osceola Supply, Inc. ALCOHOL .7 mL/mL N 20181231 62672-300_17d206d2-a7d5-4605-9626-b4c5ec099c6f 62672-300 HUMAN OTC DRUG Osceola Supply Inc 6176 CHLOROXYLENOL SOAP TOPICAL 20160722 OTC MONOGRAPH NOT FINAL part333E OSCEOLA SUPPLY, INC. CHLOROXYLENOL 6 mg/mL N 20181231 62672-608_70c2009d-179d-4815-8559-33f2c088e758 62672-608 HUMAN OTC DRUG Sani ALCOHOL GEL TOPICAL 20030701 OTC MONOGRAPH NOT FINAL part333E Osceola Supply, Inc. ALCOHOL .7 mL/mL N 20181231 62672-793_2cf75cf0-4bdb-4ff1-aa11-86e69c84dd7e 62672-793 HUMAN OTC DRUG EZ Foam 6793 TRICLOSAN SOAP TOPICAL 20170418 OTC MONOGRAPH NOT FINAL part333E OSCEOLA SUPPLY, INC. TRICLOSAN 3 mg/mL N 20181231 62673-016_603bb0ba-9e8c-4d2a-e053-2991aa0ab229 62673-016 HUMAN OTC DRUG Zincon Medicated Dandruff Pyrithione zinc SHAMPOO TOPICAL 20171213 OTC MONOGRAPH FINAL part358H Neoteric Cosmetics, Inc. PYRITHIONE ZINC .01 g/mL N 20181231 62673-058_603b049b-9ae6-27d3-e053-2991aa0a35cd 62673-058 HUMAN OTC DRUG Denorex Extra Strength Salicylic Acid SHAMPOO TOPICAL 20091101 OTC MONOGRAPH FINAL part358H Neoteric Cosmetics, Inc. SALICYLIC ACID .03 g/mL N 20181231 62673-161_7a7102c3-5c7d-437a-b979-9bfa55f12b9d 62673-161 HUMAN OTC DRUG Diabetic Advanced Healing Cream Dimethicone CREAM TOPICAL 20001001 OTC MONOGRAPH FINAL part332 Neoteric Cosmetics, Inc. DIMETHICONE .01 mg/g N 20181231 62673-162_80b3eb96-c84b-45b0-8deb-e475f49a5b21 62673-162 HUMAN OTC DRUG Dual Action Skin Lightener Hydroquinone LOTION TOPICAL 20060501 OTC MONOGRAPH NOT FINAL part358A Neoteric Cosmetics, Inc. HYDROQUINONE .02 mg/g N 20181231 62673-163_47fe4813-d099-424b-973d-b13c195f5103 62673-163 HUMAN OTC DRUG Enhanced Facial Moisturizer Octinoxate, Zinc Oxide LOTION TOPICAL 20050101 OTC MONOGRAPH FINAL part352 Neoteric Cosmetics, Inc. OCTINOXATE; ZINC OXIDE .08; .05 mg/g; mg/g N 20181231 62673-164_5df74453-c7cb-4f9a-8711-afb68c0cc118 62673-164 HUMAN OTC DRUG Moisturizing Facial Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene,Oxybenzone LOTION TOPICAL 20160401 OTC MONOGRAPH FINAL part352 Neoteric Cosmetics, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03; .1; .05; .07; .05 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 62673-174_603bb8c1-c493-d859-e053-2a91aa0aeb33 62673-174 HUMAN OTC DRUG Denorex Therapeutic Coal Tar and Menthol SHAMPOO TOPICAL 20171213 OTC MONOGRAPH FINAL part358H Neoteric Cosmetics, Inc. COAL TAR; MENTHOL .018; .015 g/mL; g/mL N 20181231 62678-206_4d732bef-4ecc-41e4-8965-8ef07a330395 62678-206 HUMAN OTC DRUG Dental plus Extra Menta SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100519 OTC MONOGRAPH FINAL part355 Tropical International Manufacturing Inc SODIUM MONOFLUOROPHOSPHATE 8 mg/g E 20171231 62678-207_4321f703-7907-4dbe-988f-aab8ab236978 62678-207 HUMAN OTC DRUG Dental plus Baking Soda SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100519 OTC MONOGRAPH FINAL part355 Tropical International Manufacturing Inc SODIUM MONOFLUOROPHOSPHATE 8 mg/g E 20171231 62678-216_d7743258-adbd-4b4b-a382-5479f0e640e4 62678-216 HUMAN OTC DRUG Dental plus Whitening SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100519 OTC MONOGRAPH FINAL part355 Tropical International Manufacturing Inc SODIUM MONOFLUOROPHOSPHATE 8 mg/g E 20171231 62678-217_07e7c00b-174e-4de7-99c2-10c5533183b1 62678-217 HUMAN OTC DRUG Dental plus Regular Flavor SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100519 OTC MONOGRAPH FINAL part355 Tropical International Manufacturing Inc SODIUM MONOFLUOROPHOSPHATE 8 mg/g E 20171231 62695-1001_cab51b1d-a07b-4249-a146-bde1ddb992da 62695-1001 HUMAN OTC DRUG Any Mi Natural Magic BB No.5 ALLANTOIN CREAM TOPICAL 20140315 OTC MONOGRAPH FINAL part347 K.N.Life Co., Ltd. ALLANTOIN .0005 g/mL E 20171231 62695-2001_cf71be34-af09-46c1-bc02-31815719ee3d 62695-2001 HUMAN OTC DRUG Any Mi Natural Magic BB No.7 ALLANTOIN CREAM TOPICAL 20140315 OTC MONOGRAPH FINAL part347 K.N.Life Co., Ltd. ALLANTOIN .0005 g/mL E 20171231 62699-1112_25e0da6b-c77e-4925-a8f7-6c54508eacd3 62699-1112 HUMAN OTC DRUG Golden Sunshine Far Infrared HOT Herbal Topical Analgesic PATCH TOPICAL 20040802 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .03; .005 g/g; g/g E 20171231 62699-1114_c4a36e62-44f6-4398-a66e-c79a60938ca4 62699-1114 HUMAN OTC DRUG Golden Sunshine Herbal Topical Analgesic SPRAY TOPICAL 20040802 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .00781; .03 g/g; g/g E 20171231 62699-1123_e71c9ccb-ba4d-4c83-b7c8-a2f969a35831 62699-1123 HUMAN OTC DRUG Golden Sunshine Herbal Topical Analgesic CREAM TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .02; .005 g/g; g/g E 20171231 62699-2211_96a94ddd-3e78-48f1-909a-9f6c3eff7eec 62699-2211 HUMAN OTC DRUG Golden Sunshine Far Infrared Herbal Topical Analgesic PASTE TOPICAL 20090223 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .03; .03 g/g; g/g E 20171231 62699-2212_c75b8056-b709-461d-b9ff-f35b0fd166e1 62699-2212 HUMAN OTC DRUG Golden Sunshine Far Infrared COOL Herbal Topical Analgesic PATCH TOPICAL 20040802 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .03; .005 g/g; g/g E 20171231 62699-3312_32ec8693-cf32-4155-b08e-dba0b84cbca1 62699-3312 HUMAN OTC DRUG PAIN Terminator Analgesic Topical Analgesic PATCH TOPICAL 20060518 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .03; .005 g/g; g/g E 20171231 62699-3313_ce5e00d1-2767-491b-8b11-2e687045faf6 62699-3313 HUMAN OTC DRUG PAIN Terminator Analgesic Topical Analgesic CREAM TOPICAL 20090223 OTC MONOGRAPH NOT FINAL part348 Nan Mei Pharmaceutical Co., Ltd. MENTHOL; METHYL SALICYLATE .02; .005 g/g; g/g E 20171231 62712-221_4f76a1ca-05da-4535-ab8f-4bfd76188147 62712-221 HUMAN OTC DRUG Free Hand ALCOHOL GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333E Atco International ALCOHOL .7 mL/mL N 20181231 62712-575_c8baa644-5165-4b19-a6bd-636d71b6bec6 62712-575 HUMAN OTC DRUG Handi-San BENZETHONIUM CHLORIDE LIQUID TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333E Atco International BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 62712-783_797284db-4179-42c0-8c5b-2266cd516d30 62712-783 HUMAN OTC DRUG Quick San ll Hand Sanitizer Wipes ALCOHOL CLOTH TOPICAL 20171218 OTC MONOGRAPH NOT FINAL part333E Atco International ALCOHOL 620 mg/g N 20181231 62713-801_2651d84a-d1f2-25dd-e054-00144ff8d46c 62713-801 HUMAN OTC DRUG Allergena Zone 1 Echinacea, Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 1 Tree, Zone 1 Weed, Zone 1 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; POPULUS TREMULOIDES POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA NIGRA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA TOMENTOSA POLLEN; LIGUSTRUM VULGARE POLLEN; ACER SACCHARUM POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN; QUERCUS VELUTINA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN; PINUS STROBUS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; PICEA PUNGENS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN; RUMEX CRISPUS POLLEN; SOLIDAGO CANADENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS SPINOSUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS TUBERCULATUS POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA ABSINTHIUM POLLEN; CYNODON DACTYLON POLLEN; BROMUS INERMIS POLLEN; PHALARIS ARUNDINACEA POLLEN; ZEA MAYS POLLEN; SORGHUM HALEPENSE POLLEN; KOELERIA MACRANTHA POLLEN; FESTUCA PRATENSIS TOP; AVENA SATIVA POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; SORGHUM X DRUMMONDII POLLEN; ANTHOXANTHUM ODORATUM POLLEN; PHLEUM PRATENSE POLLEN; HOLCUS LANATUS POLLEN; TRITICUM AESTIVUM POLLEN 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-802_25d90e59-ddc2-1703-e054-00144ff88e88 62713-802 HUMAN OTC DRUG Allergena Zone 2 Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 2 Tree, Zone 2 Weed, Zone 2 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ACACIA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; BETULA OCCIDENTALIS POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; TAXODIUM DISTICHUM POLLEN; ULMUS AMERICANA POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA OVATA POLLEN; LIGUSTRUM VULGARE POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN; MORUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS STROBUS POLLEN; POPULUS ALBA POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM POLLEN; RUMEX CRISPUS POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PASPALUM NOTATUM POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; LOLIUM PERENNE POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-803_2651e738-60c7-3203-e054-00144ff8d46c 62713-803 HUMAN OTC DRUG Allergena Zone 3 Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 3 Tree, Zone 3 Weed, Zone 3 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; POPULUS TREMULOIDES POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA OCCIDENTALIS POLLEN; BETULA PAPYRIFERA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA TOMENTOSA POLLEN; ACER SACCHARUM POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN; QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS STROBUS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; LIGUSTRUM VULGARE POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM POLLEN; RUMEX CRISPUS POLLEN; SOLIDAGO CANADENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA LUDOVICIANA POLLEN; RUMEX ACETOSELLA POLLEN; AMARANTHUS TUBERCULATUS POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA ABSINTHIUM POLLEN; CYNODON DACTYLON POLLEN; POA ANNUA POLLEN; BROMUS INERMIS POLLEN; PHALARIS ARUNDINACEA POLLEN; ZEA MAYS POLLEN; SORGHUM HALEPENSE POLLEN; KOELERIA MACRANTHA POLLEN; POA PRATENSIS POLLEN; FESTUCA PRATENSIS POLLEN; AVENA SATIVA POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; SORGHUM BICOLOR POLLEN; TRITICUM AESTIVUM POLLEN; PASCOPYRUM SMITHII POLLEN 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-805_fc1a6312-d410-428a-8d07-bfe7f47fcbe9 62713-805 HUMAN OTC DRUG Allergena Trees, Weeds and Grasses - Zone 5 Kids Allergena Trees, Weeds and Grasses - Zone 5 Kids LIQUID ORAL 20111010 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; MYRRH; RORIPPA NASTURTIUM-AQUATICUM; PHYTOLACCA AMERICANA ROOT; FENUGREEK SEED; CYNODON DACTYLON POLLEN; POA ANNUA POLLEN; BROMUS INERMIS POLLEN; PHALARIS ARUNDINACEA POLLEN; ZEA MAYS POLLEN; SORGHUM HALEPENSE POLLEN; KOELERIA MACRANTHA POLLEN; FESTUCA PRATENSIS POLLEN; ARRHENATHERUM ELATIUS POLLEN; AVENA SATIVA POLLEN; DACTYLIS GLOMERATA POLLEN; ELYMUS REPENS POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN; PHLEUM PRATENSE POLLEN; TRITICUM AESTIVUM POLLEN; PASCOPYRUM SMITHII POLLEN; ACACIA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA LENTA POLLEN; BETULA POPULIFOLIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS TREMULOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; CUPRESSUS ARIZONICA POLLEN; TAXODIUM DISTICHUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; ULMUS CRASSIFOLIA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA GLABRA POLLEN; CARYA OVATA POLLEN; CARYA LACINIOSA POLLEN; CARYA TOMENTOSA POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; LIGUSTRUM VULGARE POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; PROSOPIS JULIFLORA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN; QUERCUS KELLOGGII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS NIGRA POLLEN; PINUS TAEDA POLLEN; PINUS SYLVESTRIS POLLEN; PINUS STROBUS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; PICEA PUNGENS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM POLLEN; RUMEX CRISPUS POLLEN; BASSIA SCOPARIA POLLEN; SOLIDAGO CANADENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; IVA ANGUSTIFOLIA POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; SALSOLA TRAGUS POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA DRACUNCULUS POLLEN; ARTEMISIA FRIGIDA POLLEN; RUMEX CRISPUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; ATRIPLEX CANESCENS POLLEN; ARTEMISIA ANNUA POLLEN 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-806_265171cc-06af-190d-e054-00144ff8d46c 62713-806 HUMAN OTC DRUG Allergena Trees, Weeds and Grasses - Zone 6 Allergena Trees, Weeds and Grasses - Zone 6 LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; MYRRH; RORIPPA NASTURTIUM-AQUATICUM; PHYTOLACCA AMERICANA ROOT; FENUGREEK SEED; CYNODON DACTYLON POLLEN; POA ANNUA POLLEN; BROMUS INERMIS POLLEN; PHALARIS ARUNDINACEA POLLEN; ZEA MAYS POLLEN; SORGHUM HALEPENSE POLLEN; KOELERIA MACRANTHA POLLEN; FESTUCA PRATENSIS POLLEN; ARRHENATHERUM ELATIUS POLLEN; AVENA SATIVA POLLEN; DACTYLIS GLOMERATA POLLEN; ELYMUS REPENS POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN; PHLEUM PRATENSE POLLEN; TRITICUM AESTIVUM POLLEN; PASCOPYRUM SMITHII POLLEN; ACACIA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; POPULUS TREMULOIDES POLLEN; ACER NEGUNDO POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; CUPRESSUS ARIZONICA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; LIGUSTRUM VULGARE POLLEN; PROSOPIS JULIFLORA POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN; QUERCUS ALBA POLLEN; OLEA EUROPAEA POLLEN; PINUS NIGRA POLLEN; PINUS TAEDA POLLEN; PINUS SYLVESTRIS POLLEN; PINUS STROBUS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; AILANTHUS ALTISSIMA POLLEN; SALIX NIGRA POLLEN; ATRIPLEX POLYCARPA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM POLLEN; BASSIA SCOPARIA POLLEN; SOLIDAGO CANADENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ARTEMISIA DRACUNCULUS POLLEN; ARTEMISIA FRIGIDA POLLEN; ATRIPLEX WRIGHTII POLLEN; ATRIPLEX CONFERTIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-807_2651dcca-252d-2480-e054-00144ff8d46c 62713-807 HUMAN OTC DRUG Allergena Zone 7 Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 7 Tree, Zone 7 Weed, Zone 7 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; FRAXINUS AMERICANA POLLEN; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ALNUS INCANA SUBSP. RUGOSA POLLEN; POPULUS TREMULOIDES POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; ACER NEGUNDO POLLEN; ULMUS PUMILA POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA TOMENTOSA POLLEN; JUNIPERUS SCOPULORUM POLLEN; ACER SACCHARUM POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN; QUERCUS VIRGINIANA POLLEN; PINUS STROBUS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; LIGUSTRUM VULGARE POLLEN; PICEA PUNGENS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM POLLEN; BASSIA SCOPARIA POLLEN; SOLIDAGO CANADENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; PLANTAGO LANCEOLATA POLLEN; URTICA DIOICA POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ATRIPLEX CONFERTIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA TRAGUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; ATRIPLEX CANESCENS POLLEN; ARTEMISIA ABSINTHIUM POLLEN; POA ANNUA POLLEN; BROMUS INERMIS POLLEN; PHALARIS ARUNDINACEA POLLEN; ZEA MAYS POLLEN; SORGHUM HALEPENSE POLLEN; KOELERIA MACRANTHA POLLEN; FESTUCA PRATENSIS POLLEN; AVENA SATIVA POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM MULTIFLORUM POLLEN; SORGHUM X DRUMMONDII POLLEN; PHLEUM PRATENSE POLLEN; TRITICUM AESTIVUM POLLEN; PASCOPYRUM SMITHII POLLEN 3; 3; 30; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-808_2651e738-60d2-3203-e054-00144ff8d46c 62713-808 HUMAN OTC DRUG Allergena Zone 8 Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 8 Tree, Zone 8 Weed, Zone 8 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ALNUS RUBRA POLLEN; FRAXINUS AMERICANA POLLEN; POPULUS TREMULOIDES POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; PSEUDOTSUGA MENZIESII POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA TOMENTOSA POLLEN; JUNIPERUS SCOPULORUM POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN; MORUS ALBA POLLEN; PINUS STROBUS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; LIGUSTRUM VULGARE POLLEN; PICEA PUNGENS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS REGIA POLLEN; SALIX NIGRA POLLEN; XANTHIUM STRUMARIUM POLLEN; BASSIA SCOPARIA POLLEN; SOLIDAGO CANADENSIS POLLEN; SARCOBATUS VERMICULATUS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA ACANTHICARPA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA LUDOVICIANA POLLEN; ATRIPLEX CONFERTIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; SALSOLA TRAGUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; ATRIPLEX CANESCENS POLLEN; ARTEMISIA ABSINTHIUM POLLEN; BROMUS INERMIS POLLEN; PHALARIS ARUNDINACEA POLLEN; ZEA MAYS POLLEN; LOLIUM MULTIFLORUM POLLEN; SORGHUM HALEPENSE POLLEN; POA PRATENSIS POLLEN; FESTUCA PRATENSIS POLLEN; AVENA SATIVA POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; TRITICUM AESTIVUM POLLEN; PASCOPYRUM SMITHII POLLEN 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-809_25d9efa7-97ed-3447-e054-00144ff88e88 62713-809 HUMAN OTC DRUG Allergena Zone 9 Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 9 Tree, Zone 9 Weed, Zone 9 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations AMBROSIA PSILOSTACHYA POLLEN; SALSOLA TRAGUS POLLEN; CYNODON DACTYLON POLLEN; BROMUS INERMIS POLLEN; BROMUS SECALINUS POLLEN; SORGHUM HALEPENSE POLLEN; POA PRATENSIS POLLEN; FESTUCA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ACACIA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; EUCALYPTUS GLOBULUS POLLEN; JUNIPERUS SCOPULORUM POLLEN; LIGUSTRUM VULGARE POLLEN; PROSOPIS JULIFLORA POLLEN; MORUS ALBA POLLEN; QUERCUS AGRIFOLIA POLLEN; OLEA EUROPAEA POLLEN; PHOENIX DACTYLIFERA POLLEN; PINUS STROBUS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; ATRIPLEX CANESCENS POLLEN; AMARANTHUS PALMERI POLLEN; RUMEX CRISPUS POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA ACANTHICARPA POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-810_2651bf11-4d69-43ba-e054-00144ff88e88 62713-810 HUMAN OTC DRUG Allergena Hawaii, Puerto Rico and the Virgin Islands Echinacea, Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Tropical Tree, Tropical Weed, Tropical Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ACACIA POLLEN; ALNUS RUBRA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; MORELLA CERIFERA POLLEN; EUCALYPTUS GLOBULUS POLLEN; PROSOPIS JULIFLORA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN; QUERCUS ALBA POLLEN; PHOENIX DACTYLIFERA POLLEN; PINUS STROBUS POLLEN; LIGUSTRUM VULGARE POLLEN; JUGLANS NIGRA POLLEN; XANTHIUM STRUMARIUM POLLEN; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; CHENOPODIUM ALBUM POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PASPALUM NOTATUM POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; ANTHOXANTHUM ODORATUM POLLEN 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-811_25627007-83f4-73d4-e054-00144ff8d46c 62713-811 HUMAN OTC DRUG Allergena Mold Mix Echinacea, Baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-Graecum, Acremonium, Alternaria Tenuis, Aspergillus Mixture, Aureobasidium, Botrytis Cinerea, Chaetomium Globosum, Cladosporium Cladosporioides, Curvularia, Drechslera, Epicoccum Nigrum, Fusarium, Mucor, Neurospora, Nigrospora, Penicillium Mixture, Phoma Herbarum, Rhizopus, Rhodotorula Rubra, Stemphylium, Torula Cerevisiae, Trichoderma Lignorum, Trichophyton Mentagrophytes LIQUID ORAL 19990101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ACREMONIUM STRICTUM; ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; BOTRYTIS CINEREA; CHAETOMIUM GLOBOSUM; CLADOSPORIUM CLADOSPORIOIDES; COCHLIOBOLUS SPICIFER; EPICOCCUM NIGRUM; HAEMATONECTRIA HAEMATOCOCCA; MUCOR PLUMBEUS; NEUROSPORA SITOPHILA; KHUSKIA ORYZAE; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA EXIGUA VAR. EXIGUA; RHIZOPUS STOLONIFER; RHODOTORULA RUBRA; STEMPHYLIUM SARCINIFORME; TRICHODERMA VIRIDE; TRICHOPHYTON MENTAGROPHYTES 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-812_256297fa-c58c-72f6-e054-00144ff88e88 62713-812 HUMAN OTC DRUG Allergena Dust Plus Mite Echinacea, Baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-Graecum, Blatta Orientalis (Oriental Cockroach) HPUS, Dust Mite (D.Pteronyssinus, D. Farinae), Grain Dust (Barley, Corn, Millet, Oat, Rice, Wheat), House Dust (Mattress, Rug, Upholstery), Periplaneta Americana, Stannum Metallicum LIQUID ORAL 19990101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; BLATTA ORIENTALIS; DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; BARLEY; CORN; MILLET; OAT; BROWN RICE; WHEAT BRAN; HOUSE DUST; PERIPLANETA AMERICANA; TIN 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-814_256208d7-1423-6105-e054-00144ff88e88 62713-814 HUMAN OTC DRUG Allergena Fragrance Allergena Fragrance LIQUID ORAL 20120901 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations GOLDENSEAL; ARNICA MONTANA; LYCOPERDON UTRIFORME FRUITING BODY; CICUTA VIROSA ROOT; EUPHORBIA RESINIFERA RESIN; KEROSENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; PHOSPHORUS; LEAD; SULFUR 4; 6; 6; 6; 6; 6; 8; 8; 8; 8; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-815_2651972e-ac00-2792-e054-00144ff88e88 62713-815 HUMAN OTC DRUG Progena Lyme Disease Avena sativa, Carduus marianus, Scrophularia nodosa, Solidago virgaurea, Arsenicum album, Cina, Conium maculatum, Gelsemium sempervirens, Lycopodium clavatum, Mercuris vivus, Phosphoricum acidum, Phosphorus, Selenium metallicum LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations AVENA SATIVA FLOWERING TOP; SILYBUM MARIANUM SEED; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; ARSENIC TRIOXIDE; ARTEMISIA CINA PRE-FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62713-816_a15f84d5-f797-4c3c-be2d-098e38f8ebed 62713-816 HUMAN OTC DRUG Allergena Texas Trees Kids Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Texas Tree, Texas Weed, Texas Grass LIQUID ORAL 20110101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ACACIA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA LENTA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; CUPRESSUS ARIZONICA POLLEN; TAXODIUM DISTICHUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; ULMUS CRASSIFOLIA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA CORDIFORMIS POLLEN; CARYA GLABRA POLLEN; CARYA OVATA POLLEN; CARYA TOMENTOSA POLLEN; JUNIPERUS ASHEI POLLEN; LIGUSTRUM VULGARE POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; PROSOPIS JULIFLORA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN; QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS NIGRA POLLEN; PINUS TAEDA POLLEN; PINUS SYLVESTRIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; PICEA PUNGENS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM POLLEN; RUMEX CRISPUS POLLEN; BASSIA SCOPARIA POLLEN; SOLIDAGO CANADENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; IVA ANGUSTIFOLIA POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; SALSOLA TRAGUS POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA FRIGIDA POLLEN; RUMEX OBTUSIFOLIUS POLLEN; RUMEX CRISPUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; ATRIPLEX CANESCENS POLLEN; ARTEMISIA ANNUA POLLEN; CYNODON DACTYLON POLLEN; POA ANNUA POLLEN; BROMUS INERMIS POLLEN; ZEA MAYS POLLEN; SORGHUM HALEPENSE POLLEN; KOELERIA MACRANTHA POLLEN; FESTUCA PRATENSIS POLLEN; ARRHENATHERUM ELATIUS POLLEN; AVENA SATIVA POLLEN; DACTYLIS GLOMERATA POLLEN; ELYMUS REPENS POLLEN; AGROSTIS GIGANTEA POLLEN; PHALARIS ARUNDINACEA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN; PHLEUM PRATENSE POLLEN; TRITICUM AESTIVUM POLLEN; PASCOPYRUM SMITHII POLLEN 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-817_25da8120-5b5b-16c7-e054-00144ff8d46c 62713-817 HUMAN OTC DRUG Allergena Zone 4 Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Zone 4 Tree, Zone 4 Weed, Zone 4 Grass LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ACACIA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA LENTA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; CUPRESSUS ARIZONICA POLLEN; TAXODIUM DISTICHUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; ULMUS CRASSIFOLIA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA CORDIFORMIS POLLEN; CARYA GLABRA POLLEN; CARYA OVATA POLLEN; CARYA TOMENTOSA POLLEN; JUNIPERUS ASHEI POLLEN; LIGUSTRUM VULGARE POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; PROSOPIS JULIFLORA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN; QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS NIGRA POLLEN; PINUS TAEDA POLLEN; PINUS SYLVESTRIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; PICEA PUNGENS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM POLLEN; BASSIA SCOPARIA POLLEN; SOLIDAGO CANADENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; IVA ANGUSTIFOLIA POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; SALSOLA TRAGUS POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA FRIGIDA POLLEN; RUMEX OBTUSIFOLIUS POLLEN; RUMEX CRISPUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; ATRIPLEX CANESCENS POLLEN; ARTEMISIA ANNUA POLLEN; CYNODON DACTYLON POLLEN; POA ANNUA POLLEN; BROMUS INERMIS POLLEN; ZEA MAYS POLLEN; SORGHUM HALEPENSE POLLEN; KOELERIA MACRANTHA POLLEN; FESTUCA PRATENSIS POLLEN; ARRHENATHERUM ELATIUS POLLEN; AVENA SATIVA POLLEN; DACTYLIS GLOMERATA POLLEN; ELYMUS REPENS POLLEN; AGROSTIS GIGANTEA POLLEN; PHALARIS ARUNDINACEA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN; PHLEUM PRATENSE POLLEN; TRITICUM AESTIVUM POLLEN; PASCOPYRUM SMITHII POLLEN 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-818_2651972e-ac0e-2792-e054-00144ff88e88 62713-818 HUMAN OTC DRUG Allergena Texas Cedar Fever Echinacea,Baptisia tinctoria, Hydrastis canadensis, Myrrha, Nasturtium aquaticum, Phytolacca decandra, Trigonella foenum-graecum, Texas Tree, Texas Weed, Texas Grass LIQUID ORAL 20110101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations CUPRESSUS ARIZONICA POLLEN; TAXODIUM DISTICHUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS PUMILA POLLEN; ULMUS CRASSIFOLIA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA CORDIFORMIS POLLEN; CARYA GLABRA POLLEN; CARYA OVATA POLLEN; CARYA TOMENTOSA POLLEN; JUNIPERUS ASHEI POLLEN; LIGUSTRUM VULGARE POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; PROSOPIS JULIFLORA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; MORUS RUBRA POLLEN; MORUS ALBA POLLEN; QUERCUS VELUTINA POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS STELLATA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS NIGRA POLLEN; PINUS TAEDA POLLEN; PINUS SYLVESTRIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; PICEA PUNGENS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; AILANTHUS ALTISSIMA POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; AMPHIACHYRIS DRACUNCULOIDES POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM POLLEN; BASSIA SCOPARIA POLLEN; SOLIDAGO CANADENSIS POLLEN; CHENOPODIUM ALBUM POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; IVA ANNUA POLLEN; IVA ANGUSTIFOLIA POLLEN; CHENOPODIUM AMBROSIOIDES POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; SALSOLA TRAGUS POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA FRIGIDA POLLEN; RUMEX OBTUSIFOLIUS POLLEN; RUMEX CRISPUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; ATRIPLEX CANESCENS POLLEN; ARTEMISIA ANNUA POLLEN; CYNODON DACTYLON POLLEN; POA ANNUA POLLEN; BROMUS INERMIS POLLEN; ZEA MAYS POLLEN; SORGHUM HALEPENSE POLLEN; KOELERIA MACRANTHA POLLEN; FESTUCA PRATENSIS POLLEN; ARRHENATHERUM ELATIUS POLLEN; AVENA SATIVA POLLEN; DACTYLIS GLOMERATA POLLEN; ELYMUS REPENS POLLEN; AGROSTIS GIGANTEA POLLEN; ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ACACIA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA LENTA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; PHALARIS ARUNDINACEA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; SORGHUM BICOLOR POLLEN; SORGHUM BICOLOR SUBSP. DRUMMONDII POLLEN; PHLEUM PRATENSE POLLEN; TRITICUM AESTIVUM POLLEN; PASCOPYRUM SMITHII POLLEN 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-911_25da8d80-a971-1175-e054-00144ff8d46c 62713-911 HUMAN OTC DRUG Progena Lung Plus Phellandrium aquaticum, Rumex crispus, Sambucus nigra, Senega officinalis, Lung, Arsenicum album, Carbo vegetabilis, Drosera rotundifolia, Ipecacuanha, Phosphorus, Pulsatilla, Silicea, Sulphur LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations OENANTHE AQUATICA FRUIT; RUMEX CRISPUS ROOT; SAMBUCUS NIGRA FLOWERING TOP; POLYGALA SENEGA ROOT; SUS SCROFA LUNG; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; DROSERA ROTUNDIFOLIA; IPECAC; PHOSPHORUS; PULSATILLA VULGARIS; SILICON DIOXIDE; SULFUR 3; 3; 3; 3; 6; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62713-914_2651bf11-4d58-43ba-e054-00144ff88e88 62713-914 HUMAN OTC DRUG Progena Pancreas Plus Acidum Phosphoricum, Berberis Vulgaris, Bilberry, Cheidonium Majus, Creosotum, Kidney, Natrum sulpuricum, Pancreas, Syzygium Jambolanum LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations PHOSPHORIC ACID; BERBERIS VULGARIS ROOT BARK; BILBERRY; CHELIDONIUM MAJUS; WOOD CREOSOTE; PORK KIDNEY; SODIUM SULFATE; SUS SCROFA PANCREAS; SYZYGIUM CUMINI SEED 4; 2; 2; 4; 6; 6; 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62713-915_25dac91d-8c90-4f6c-e054-00144ff88e88 62713-915 HUMAN OTC DRUG Progena Thyro Plus Calcarea Iodata, Fucus Vesiculosus, Glandula Suprarenalis, Kali Iodatum, Pituitary, Spleen, Spongia Tosta, Thymus, Thyroidinum, Calcarea Carbonica, Ferrum Iodatum, Hepar Sulphuris Calcareum, Lapis Albus LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations CALCIUM IODIDE; FUCUS VESICULOSUS; SUS SCROFA ADRENAL GLAND; POTASSIUM IODIDE; SUS SCROFA PITUITARY GLAND; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERROUS IODIDE; CALCIUM SULFIDE; CALCIUM HEXAFLUOROSILICATE 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62713-917_2651bbec-d7c3-3231-e054-00144ff88e88 62713-917 HUMAN OTC DRUG Progena Thymus Plus Arsenicum Album, Belladonna, Calcarea Fluorica, Calcarea Sulphurica, Echinacea, Hepar Sulphuris Calcareum, Lachesis Mutus, Nux Moschata, Silicea, Sulphur Iodatum, Thymus Gland LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ARSENIC TRIOXIDE; ATROPA BELLADONNA; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; LACHESIS MUTA VENOM; NUTMEG; SILICON DIOXIDE; SULFUR IODIDE; SUS SCROFA THYMUS 6; 6; 8; 8; 1; 8; 12; 3; 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62713-918_2651bf11-4d4b-43ba-e054-00144ff88e88 62713-918 HUMAN OTC DRUG Progena Pituitary Plus Adrenalinum, Arnica montana, Erigeron canadensis, Hydrastis canadensis, Millefolium, Pituitary, Sabina, Secale cornutum LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations EPINEPHRINE; ARNICA MONTANA; CONYZA CANADENSIS; GOLDENSEAL; ACHILLEA MILLEFOLIUM; SUS SCROFA PITUITARY GLAND; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM 6; 6; 6; 6; 6; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62713-921_9a76c289-94c3-4b8d-a4e5-985186ee0704 62713-921 HUMAN OTC DRUG Progena Adrenal Plus Atropinum Sulphuricum, Berberis Vulgaris, Bryonia, Carduus Marianus, Chelidonium Majus, Echinacea, Glandula Suprarenalis, Lycopodium Clavatum, Magnesia Phosphorica, Spleen, Zingiber Officinale LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; ECHINACEA, UNSPECIFIED; SUS SCROFA ADRENAL GLAND; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SUS SCROFA SPLEEN; GINGER 6; 3; 4; 2; 3; 2; 6; 12; 8; 6; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62713-925_e16dd328-31c2-4fa6-85a8-4e181756b8f0 62713-925 HUMAN OTC DRUG Candicide 12X Candicide 12X LIQUID ORAL 19840301 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations BAPTISIA TINCTORIA ROOT; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CANDIDA ALBICANS; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 3; 30; 30; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62713-930_2561c0da-3cff-58b9-e054-00144ff88e88 62713-930 HUMAN OTC DRUG Candicide Candicide LIQUID ORAL 20141010 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations BAPTISIA TINCTORIA ROOT; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CANDIDA ALBICANS; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 3; 30; 30; 500; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62713-940_2651d84a-d20c-25dd-e054-00144ff8d46c 62713-940 HUMAN OTC DRUG Progena Immugen Aralia Quinquefolia, Echinacea, Phytolacca Decandra, Ascorbic Acid, Beta Carotene, Glandula Suprarenalis, Pyridoxinum Hydrochloricum, Spleen, Thymus, Selenium Metallicum, Vitamin E, Zincum Metallicum LIQUID ORAL 19850101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations AMERICAN GINSENG; ECHINACEA, UNSPECIFIED; PHYTOLACCA AMERICANA ROOT; ASCORBIC ACID; .BETA.-CAROTENE; SUS SCROFA ADRENAL GLAND; PYRIDOXINE HYDROCHLORIDE; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; SELENIUM; .ALPHA.-TOCOPHEROL; ZINC 3; 3; 3; 6; 6; 6; 6; 6; 6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-941_f5b6c281-3aa3-473b-86ce-fa44a85b0325 62713-941 HUMAN OTC DRUG Progena Attention Span Anacardium orientale, Calcarea phosphorica, Carcinosin, Iodium, Stramonium, Tarentula hispana, Veratrum album LIQUID ORAL 19900101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations SEMECARPUS ANACARDIUM JUICE; TRIBASIC CALCIUM PHOSPHATE; HUMAN BREAST TUMOR CELL; IODINE; DATURA STRAMONIUM; LYCOSA TARANTULA; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62713-942_25da8120-5b68-16c7-e054-00144ff8d46c 62713-942 HUMAN OTC DRUG Allergena Pet Dander Homeopathic Sublingual Immunotherapy LIQUID ORAL 20120801 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations BOS TAURUS ADRENAL GLAND; ECHINACEA ANGUSTIFOLIA; MAMMAL LIVER; CORTICOTROPIN; HISTAMINE; FELIS CATUS DANDER; CANIS LUPUS FAMILIARIS DANDER; EQUUS CABALLUS DANDER; BOS TAURUS DANDER; MUS MUSCULUS SKIN; MESOCRICETUS AURATUS SKIN; CAVIA PORCELLUS DANDER; ORYCTOLAGUS CUNICULUS SKIN; SUS SCROFA DANDER; CHICKEN; DUCK; GOOSE; BAPTISIA TINCTORIA; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK SEED 4; 3; 12; 30; 12; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 100; 3; 3; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-943_839b8761-0485-482e-a0a7-f1d557f1b7d6 62713-943 HUMAN OTC DRUG Allergena for Pets Allergena for Pets LIQUID ORAL 19870101 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations ECHINACEA, UNSPECIFIED; BETULA PAPYRIFERA POLLEN; JUNIPERUS ASHEI POLLEN; QUERCUS RUBRA POLLEN; ARTEMISIA VULGARIS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; SALSOLA TRAGUS POLLEN; PASPALUM NOTATUM POLLEN; CYNODON DACTYLON POLLEN; POA ANNUA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; CALENDULA OFFICINALIS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; DELPHINIUM STAPHISAGRIA SEED; URTICA URENS 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 3; 3; 3; 3; 3; 3; 3; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62713-944_4f93c177-30c4-1508-e054-00144ff8d46c 62713-944 HUMAN OTC DRUG Allergena Seasonal Allergy Tabs Allergy Relief TABLET, ORALLY DISINTEGRATING ORAL 20150105 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; ECHINACEA, UNSPECIFIED; ACACIA POLLEN; ALNUS RUBRA POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; FRAXINUS VELUTINA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; POPULUS TREMULOIDES POLLEN; MORELLA CERIFERA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA LENTA POLLEN; ROBINIA PSEUDOACACIA POLLEN; ACER NEGUNDO POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; CUPRESSUS ARIZONICA POLLEN; TAXODIUM DISTICHUM POLLEN; PHOENIX DACTYLIFERA POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; ULMUS RUBRA POLLEN; EUCALYPTUS GLOBULUS POLLEN; PSEUDOTSUGA MENZIESII POLLEN; CELTIS OCCIDENTALIS POLLEN; CARYA GLABRA POLLEN; CARYA OVATA POLLEN; CARYA LACINIOSA POLLEN; CARYA TOMENTOSA POLLEN; LIGUSTRUM VULGARE POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN; MORUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN; CARYA ILLINOINENSIS POLLEN; PINUS STROBUS POLLEN; POPULUS ALBA POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; PLATANUS OCCIDENTALIS POLLEN; JUGLANS NIGRA POLLEN; SALIX NIGRA POLLEN; BACCHARIS HALIMIFOLIA POLLEN; AMARANTHUS PALMERI POLLEN; XANTHIUM STRUMARIUM POLLEN; RUMEX CRISPUS POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA POLLEN; ARTEMISIA VULGARIS POLLEN; URTICA DIOICA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; PLANTAGO LANCEOLATA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PASPALUM NOTATUM POLLEN; CYNODON DACTYLON POLLEN; POA PRATENSIS POLLEN; FESTUCA PRATENSIS POLLEN; SORGHUM HALEPENSE POLLEN; LOLIUM PERENNE POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN 3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62713-945_25d9a863-bce6-6f20-e054-00144ff8d46c 62713-945 HUMAN OTC DRUG Meditrend TD-TROPIN PLUS Hypothalamus, Pituitary topical LIQUID TOPICAL 20150430 UNAPPROVED HOMEOPATHIC Meditrend, Inc. DBA Progena Professional Formulations BOS TAURUS HYPOTHALAMUS; BOS TAURUS PITUITARY GLAND 30; 30 [hp_X]/mL; [hp_X]/mL E 20171231 62715-0001_282e1bf8-029c-454b-97d6-53b5c2424769 62715-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19951101 UNAPPROVED MEDICAL GAS Great Plains Homecare Equipment OXYGEN 99 L/100L E 20171231 62721-0118_3e4c121a-b3ba-468a-a6c5-29801201c44a 62721-0118 HUMAN OTC DRUG Lornamead Yardley Triclosan SOAP TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part333E Lornamead TRICLOSAN .2 g/100mL N 20181231 62721-0214_24b2afa2-d351-489f-96b8-fa63009523d4 62721-0214 HUMAN OTC DRUG Big Lots Sound Body Fluoride PASTE, DENTIFRICE DENTAL 20140305 OTC MONOGRAPH NOT FINAL part356 Lornamead SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 62721-0470_e961d00c-5ba3-4b53-8f05-1077d95b4beb 62721-0470 HUMAN OTC DRUG Lornamead Natural White Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 Lornamead SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 62721-0471_5c9bad48-c405-4eb4-bacf-6f6a32ad1a37 62721-0471 HUMAN OTC DRUG Lornamead Natural White Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 Lornamead SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 62721-0472_05947ed0-2f4a-4a5d-89d9-b68fa3c04031 62721-0472 HUMAN OTC DRUG Lornamead Natural White Fluoride PASTE, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 Lornamead SODIUM FLUORIDE .24 g/100g N 20181231 62721-0473_edfc63e8-ae49-4f62-850c-1ea5f3a5e9cb 62721-0473 HUMAN OTC DRUG Natural White Radiant White Fluoride PASTE, DENTIFRICE DENTAL 20130101 OTC MONOGRAPH NOT FINAL part356 Lornamead SODIUM FLUORIDE .243 g/100g N 20181231 62721-8106_6efe4f44-9720-44d5-b47b-49e0992d8e29 62721-8106 HUMAN OTC DRUG LypSyl Honeyberry OCTINOXATE LIPSTICK TOPICAL 20091001 OTC MONOGRAPH FINAL part352 Lornamead OCTINOXATE; OCTOCRYLENE; OXYBENZONE 5.5; 2; 3.5 g/100g; g/100g; g/100g N 20181231 62721-8110_9644b4b3-6cf7-491c-afaa-603b74f22330 62721-8110 HUMAN OTC DRUG Lornamead Yardley Triclosan SOAP TOPICAL 20121201 OTC MONOGRAPH NOT FINAL part333E Lornamead TRICLOSAN .2 g/100mL E 20171231 62721-8114_486da846-a7dc-4b1c-a271-07e75aaa440b 62721-8114 HUMAN OTC DRUG Lornamead Lypsyl PETROLATUM PASTE TOPICAL 20120201 OTC MONOGRAPH FINAL part346 Lornamead PETROLATUM; MENTHOL 65.004; .3 g/100g; g/100g N 20181231 62721-8116_c7945e29-2a20-4731-a614-97ce1bdd9c1f 62721-8116 HUMAN OTC DRUG LypSyl Honeyberry Lip Balm LIPSTICK TOPICAL 20121031 OTC MONOGRAPH FINAL part352 Lornamead OCTINOXATE; OCTOCRYLENE; AVOBENZONE; OXYBENZONE 5.5; 2; 2; 3.5 g/100g; g/100g; g/100g; g/100g N 20181231 62721-8117_d48300f2-8599-47e9-8a1c-1e7c3dd826e7 62721-8117 HUMAN OTC DRUG LypSyl Vanilla Plum Intense Protection Lip Balm LIPSTICK TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part352 Lornamead OCTINOXATE; OCTOCRYLENE; AVOBENZONE; OXYBENZONE 5.5; 2; 2; 3.5 g/100g; g/100g; g/100g; g/100g N 20181231 62721-8127_2771ef5a-bde4-46b0-8a8c-d4c5d0b807ed 62721-8127 HUMAN OTC DRUG LypSyl Vanilla Plum Intense Protection Lip Balm LIPSTICK TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Lornamead OCTINOXATE; OCTOCRYLENE; AVOBENZONE; OXYBENZONE 5.5; 2; 3; 3.5 g/100g; g/100g; g/100g; g/100g N 20181231 62732-8005_4efd3602-a78b-54fa-e054-00144ff8d46c 62732-8005 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 20161214 OTC MONOGRAPH FINAL part343 Yichang Humanwell Pharmaceutical Co. Ltd. ASPIRIN 81 mg/1 N 20181231 62732-8006_4efd3602-a77b-54fa-e054-00144ff8d46c 62732-8006 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 20161214 OTC MONOGRAPH FINAL part343 Yichang Humanwell Pharmaceutical Co. Ltd. ASPIRIN 325 mg/1 N 20181231 62732-9009_4d974789-5b62-0511-e054-00144ff88e88 62732-9009 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide TABLET ORAL 20170303 OTC MONOGRAPH FINAL part341 Yichang Humanwell Pharmaceutical Co. Ltd. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 62737-123_477f641f-a3fc-4b98-813b-c1779937b2d4 62737-123 HUMAN PRESCRIPTION DRUG Oxygen oxygen GAS RESPIRATORY (INHALATION) 19960419 UNAPPROVED MEDICAL GAS Air Care Home Health Inc OXYGEN 1 L/L E 20171231 62741-0123_342e85ec-7690-4a92-af22-e6bc12a536f9 62741-0123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960605 UNAPPROVED MEDICAL GAS B&K Prescription Shop OXYGEN 99 L/100L E 20171231 62742-4028_6c2cd9ac-b90c-4ef3-8b59-7c4c231f51bd 62742-4028 HUMAN OTC DRUG SARAH CHAPMAN London SKINESIS Dynamic Defence Concentrate Anti-Ageing Day Cream SPF 15 OCTYL METHOXYCINNAMATE , OCTYL SALICYLATE, OXYBENZONE, AND AVOBENZONE CREAM TOPICAL 20100504 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 50; 50; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 62742-4029_d112300c-a0c7-4ae0-9a3d-835d817db48c 62742-4029 HUMAN OTC DRUG SARAH CHAPMAN London SKINESIS Dynamic Defence Anti-Ageing Day SPF 15 OCTYL METHOXYCINNAMATE , OCTYL SALICYLATE, OXYBENZONE, AND AVOBENZONE CREAM TOPICAL 20100506 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 50; 50; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 62742-4030_04dd129a-7c7b-42a0-8803-dbdda59396de 62742-4030 HUMAN OTC DRUG DermaQuest TM Skin Therapy, Breathable Coverage TM Mineral Foundation SPF-30, DermaMinerals TM Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part352 Allure Labs, Inc. TITANIUM DIOXIDE; ZINC OXIDE 48; 58 mg/mL; mg/mL E 20171231 62742-4031_b552f601-7915-4822-8202-136919ba22fb 62742-4031 HUMAN OTC DRUG Lycogel Cover and Recovery - Breathable Camouflage - SPF 30 with LYCO Complex Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20100201 UNAPPROVED DRUG OTHER Allure Cosmetic, Inc. TITANIUM DIOXIDE; ZINC OXIDE 65; 82 mg/mL; mg/mL E 20171231 62742-4032_6cd649e2-95e4-4138-b16d-9e95e2f328b8 62742-4032 HUMAN OTC DRUG Lycogel Cover and Recovery - Breathable Concealer - SPF 30 with LYCO Complex Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20100201 UNAPPROVED DRUG OTHER Allure Cosmetic, Inc. TITANIUM DIOXIDE; ZINC OXIDE 65; 82 mg/mL; mg/mL E 20171231 62742-4033_d9119131-1bda-4895-9d5a-98500f94cc80 62742-4033 HUMAN OTC DRUG AGELESS Total Skin Bleaching Serum HYDROQUINONE LIQUID TOPICAL 20100101 OTC MONOGRAPH FINAL part358 Allure Labs, Inc. HYDROQUINONE 20 mg/mL E 20171231 62742-4034_fc86ed15-9e81-4407-9c43-2c79a1e6d057 62742-4034 HUMAN OTC DRUG CLEAR CELL Medicated Acne Scrub Benzoyl Peroxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. BENZOYL PEROXIDE 30 mg/mL E 20171231 62742-4035_850ae55b-b7fb-47fb-bc41-0e93766c5038 62742-4035 HUMAN OTC DRUG CLEAR CELL Medicated Acne Benzoyl Peroxide, Salicylic Acid LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. BENZOYL PEROXIDE; SALICYLIC ACID 50; 30 mg/mL; mg/mL E 20171231 62742-4036_2c2af16e-4a6c-436b-bcef-ff531e8f908f 62742-4036 HUMAN OTC DRUG AGELESS Total Rejuvenating Hand Octinoxate, Octisalate, Avobenzone, Octocrylene CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 75; 50; 20; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 62742-4037_cea5b90c-cb67-4803-910e-625cba66ff37 62742-4037 HUMAN OTC DRUG SUN Solar Defense Hydrating Zinc Oxide, Ethylhexyl Methoxycinnamate, Benzophenone, Ethylhexyl Salicylate CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE; OCTINOXATE; OXYBENZONE; OCTISALATE 50; 75; 30; 50 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 62742-4038_4eca3569-57ff-4766-833a-e74496eb2969 62742-4038 HUMAN OTC DRUG SUN Solar Defense Organic SPF30 Zinc Oxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 190 mg/mL E 20171231 62742-4039_1f4eca23-2fe7-4ba0-8e19-7923e510efa8 62742-4039 HUMAN OTC DRUG SUN Solar Defense Oil-free Gel SPF 15 Titanium Dioxide, Ethylhexyl Methoxycinnamate, Benzophenone-3 CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. TITANIUM DIOXIDE; OCTINOXATE; OXYBENZONE 16; 75; 30 mg/mL; mg/mL; mg/mL E 20171231 62742-4040_e091db7c-bb5c-4180-a20b-67f7bd20125f 62742-4040 HUMAN OTC DRUG SUN Solar Defense Oil-free SPF 30 Zinc Oxide GEL TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 186 mg/mL E 20171231 62742-4041_9bdd2920-7c83-4fa7-83d9-c85a69e7e9e0 62742-4041 HUMAN OTC DRUG SUN Tinted Solar Defense Organic SPF 30 Zinc Oxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 170 mg/mL E 20171231 62742-4042_c7853422-d511-4d01-b8fb-577cab24e80b 62742-4042 HUMAN OTC DRUG Clear Cell Salicylic Clarifying Pads Salicylic Acid LIQUID TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. SALICYLIC ACID 50 mg/mL E 20171231 62742-4043_86dde41e-2909-4f02-a32c-01b8eac550fe 62742-4043 HUMAN OTC DRUG Clear Cell Salicylic Clarifying Tonic Salicylic Acid and Glycolic Acid LIQUID TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. SALICYLIC ACID; GLYCOLIC ACID 30; 50 mg/mL; mg/mL E 20171231 62742-4044_fc49cd9b-0e3f-4a43-acd9-1fcd12912f78 62742-4044 HUMAN OTC DRUG Clear Cell Medicated Acne Masque Salicylic Acid CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. SALICYLIC ACID 50 mg/mL E 20171231 62742-4045_8362fe8b-006d-46bd-a031-d4945a4ca543 62742-4045 HUMAN OTC DRUG Clear Cell Cleanser Salicylic Acid GEL TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. SALICYLIC ACID 30 mg/mL E 20171231 62742-4046_e379ec77-67e5-4867-9f91-b2add725aa16 62742-4046 HUMAN OTC DRUG Image MD Lightening Rx Hydroquinone CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part358 Allure Labs, Inc. HYDROQUINONE 40 mg/mL E 20171231 62742-4047_e657a245-4cb4-4b20-a54c-358bd8020cd9 62742-4047 HUMAN OTC DRUG No Foundation SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE; TITANIUM DIOXIDE 122; 32 mg/mL; mg/mL E 20171231 62742-4048_fbdbe9ea-323a-4651-b480-28864dc02675 62742-4048 HUMAN OTC DRUG No Foundation SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE; TITANIUM DIOXIDE 122; 32 mg/mL; mg/mL E 20171231 62742-4049_d602176d-bde5-462c-bb52-714baf35a214 62742-4049 HUMAN OTC DRUG More Than Moisture SPF 30 Zinc Oxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 105 mg/mL E 20171231 62742-4050_2277495d-ecbd-44de-84cd-c822b80275cd 62742-4050 HUMAN OTC DRUG Acne TX Mask Benzoyl Peroxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Allure Labs, Inc. BENZOYL PEROXIDE 25 mg/mL E 20171231 62742-4051_9ff762a4-f617-49f4-b8fa-07a39880c4ff 62742-4051 HUMAN OTC DRUG Dermaquest Skin Therapy Post-Skin Resurfacing Balm Hydrocortisone CREAM TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part348 Allure Labs, Inc. HYDROCORTISONE 10 mg/mL E 20171231 62742-4052_c54081b5-aa9f-4b30-a94a-7a29082d490f 62742-4052 HUMAN OTC DRUG Dermaquest Skin Therapy Solar Protection SPF 15 Zinc Oxide CREAM TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 95 mg/mL E 20171231 62742-4053_ac4da00a-cc70-4ef2-a4b1-c3a6a704c8d4 62742-4053 HUMAN OTC DRUG Dermaquest Skin Therapy Daily Moisturizing SPF 15 Zinc Oxide LOTION TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 95 mg/mL E 20171231 62742-4054_ab247f5b-0ebb-4e51-b1ce-17351941d7c6 62742-4054 HUMAN OTC DRUG Kid Safe Screen Zinc Oxide CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 Allure Labs, Inc. ZINC OXIDE 200 mg/mL N 20181231 62742-4055_bc35bc0c-2021-43c4-919f-4c18913fa9ad 62742-4055 HUMAN OTC DRUG Moisturizing Face Screen Medium Tint SPF 30 Zinc Oxide CREAM TOPICAL 20100901 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 200 mg/mL N 20181231 62742-4056_3ebef773-faf0-4621-9560-3b8d9d1acac5 62742-4056 HUMAN OTC DRUG Moisturizing Face Screen SPF 30 Zinc Oxide CREAM TOPICAL 20100901 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 200 mg/mL N 20181231 62742-4057_e2570a5d-9851-4267-bdd1-f7ad574c1686 62742-4057 HUMAN OTC DRUG Moisturizing Face Screen Light Tint SPF 30 Zinc Oxide CREAM TOPICAL 20100901 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE 200 mg/mL N 20181231 62742-4058_a268c744-6523-47b0-9f3c-d53ebdf7b904 62742-4058 HUMAN OTC DRUG Anti-Bacterial Wash with Exfoliating Beads for Blemish skin Benzoyl Peroxide GEL TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333D Allure Labs, Inc. BENZOYL PEROXIDE 25 mg/mL E 20171231 62742-4059_ec8a7b23-aa83-406f-854b-a3474a716798 62742-4059 HUMAN OTC DRUG No Concealer Concealer Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20131209 OTC MONOGRAPH FINAL part352 Allure Labs, Inc TITANIUM DIOXIDE; ZINC OXIDE 48; 58.8 mg/g; mg/g E 20171231 62742-4060_908dfa20-4f1d-4c34-b85e-f5ec09b7eda7 62742-4060 HUMAN OTC DRUG No Foundation Foundation Fair Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20131216 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 122; 32 mg/mL; mg/mL E 20171231 62742-4061_2e3befa1-ca89-42df-9933-d2403b24a6e3 62742-4061 HUMAN OTC DRUG No Foundation SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20131231 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE; TITANIUM DIOXIDE 122; 32 mg/mL; mg/mL E 20171231 62742-4062_7ff3a174-91b1-4411-bdc2-95b4a2369eac 62742-4062 HUMAN OTC DRUG No Concealer Concealer No.2 Light to Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140326 OTC MONOGRAPH FINAL part352 Allure Labs, Inc TITANIUM DIOXIDE; ZINC OXIDE 48; 58.8 mg/g; mg/g E 20171231 62742-4063_be855b3f-4c30-48f4-9fbb-514209d00242 62742-4063 HUMAN OTC DRUG No Foundation Foundation No.1 Fair to Light Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20140418 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 122; 32 mg/mL; mg/mL E 20171231 62742-4064_2aeda5d4-0cd2-4cd8-a12d-880ded11d9d2 62742-4064 HUMAN OTC DRUG ZinClear SPF 30 Tinted Zinc Oxide CREAM TOPICAL 20140422 OTC MONOGRAPH FINAL part352 Allure Labs Inc. ZINC OXIDE 186 mg/g E 20171231 62742-4066_2032c3e0-9ada-4654-a245-53577d1243ef 62742-4066 HUMAN OTC DRUG No Foundation Foundation No.2 Light to Medium Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20140414 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. ZINC OXIDE; TITANIUM DIOXIDE 122; 32 mg/mL; mg/mL E 20171231 62742-4067_e200363c-eb83-4b5d-be27-390b206852f9 62742-4067 HUMAN OTC DRUG Prevention daily tinted mositurizer oil-free Tinted 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20140509 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 60; 46 mg/g; mg/g E 20171231 62742-4068_c212882f-4802-4f7c-b4f4-3b71ec62ac04 62742-4068 HUMAN OTC DRUG Youth Protection SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 186; 20 mg/g; mg/g E 20171231 62742-4069_1b18b212-1d3d-4511-936b-552d6094721e 62742-4069 HUMAN OTC DRUG DermaClear Serum Salicylic ACid CREAM TOPICAL 20140530 OTC MONOGRAPH FINAL part333D Allure Labs, Inc SALICYLIC ACID 20 mg/mL E 20171231 62742-4070_616b9d44-1e75-4257-9beb-62bed2946b9f 62742-4070 HUMAN OTC DRUG Clarifying Toner Salicylic Acid LIQUID TOPICAL 20140607 OTC MONOGRAPH FINAL part333D Allure Labs, Inc SALICYLIC ACID 10 mg/mL E 20171231 62742-4071_bcc0b356-4c14-46e9-8ad9-aa2db6f6bdf0 62742-4071 HUMAN OTC DRUG Foaming Cleanser Salicylic Acid LIQUID TOPICAL 20140607 OTC MONOGRAPH FINAL part333D Allure Labs, Inc SALICYLIC ACID 20 mg/mL E 20171231 62742-4072_8e09e1c4-7b7b-4a2f-89d5-f0251b9da39a 62742-4072 HUMAN OTC DRUG Acne LotionSulfur Sulfur Sulfur LOTION TOPICAL 20140610 OTC MONOGRAPH FINAL part333D Allure Labs, Inc SULFUR 30 mg/mL E 20171231 62742-4073_2cf57334-fa04-41f3-964d-edbe1dc8f31e 62742-4073 HUMAN OTC DRUG Derma Brilliance Sunscreen SPF 30 Octinoxate, Oxybenzone, Octisalate, Avobenzone and Octocrylene CREAM TOPICAL 20150317 OTC MONOGRAPH FINAL part352 Allure Labs, Inc OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 7.5; 6; 5; 2; 1.5 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 62742-4074_2d07030a-ee1a-4994-8f86-366e1e3ba447 62742-4074 HUMAN OTC DRUG Dermaclear Mask Salicylic Acid CREAM TOPICAL 20150504 OTC MONOGRAPH FINAL part333D Allure Labs, Inc SALICYLIC ACID 20 mg/g E 20171231 62742-4075_81d0b450-9900-45b7-ba2d-055979fc37f2 62742-4075 HUMAN OTC DRUG DermaClear Spot Treatment Benzoyl Peroxide CREAM TOPICAL 20150505 OTC MONOGRAPH FINAL part333D Allure Labs, Inc BENZOYL PEROXIDE 100 mg/g E 20171231 62742-4076_88961215-2943-4add-a3f9-4684e7e209e7 62742-4076 HUMAN OTC DRUG DermaClear Pads Salicylic Acid LIQUID TOPICAL 20150508 OTC MONOGRAPH FINAL part333D Allure Labs, Inc SALICYLIC ACID 20 mg/g E 20171231 62742-4077_71288431-25f4-4179-8945-6c54f9e91016 62742-4077 HUMAN OTC DRUG Post Treatment Balm Hydrocortisone CREAM TOPICAL 20150512 OTC MONOGRAPH NOT FINAL part348 Allure Labs, Inc HYDROCORTISONE 1 mg/g E 20171231 62742-4078_f003ccad-e829-4783-a5c2-c78b5791c00e 62742-4078 HUMAN OTC DRUG Solar Moisturizer SPF 30 Octinoxate, Oxybenzone, Octisalate, Avobenzone, Octocrylene CREAM TOPICAL 20150512 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 7.5; 6; 5; 2; 1.5 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 62742-4079_d05521b6-c493-4d14-9675-e0a6d0a68143 62742-4079 HUMAN OTC DRUG SPF 30 Body Sunscreen Avobenzone,Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20151103 OTC MONOGRAPH FINAL part352 Alure Labs, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75; 50; 15; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 62742-4080_15ce94d7-34c6-4bb9-b899-8ab0c316af7b 62742-4080 HUMAN OTC DRUG SPF 30 Body Sunscreen Fragrance Free Avobenzone,Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20151103 OTC MONOGRAPH FINAL part352 Alure Labs, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75; 50; 15; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 62742-4081_a3c50740-bff9-49b4-a9ea-2478cb29a2eb 62742-4081 HUMAN OTC DRUG SPF 15 Lip Conditioner Avobenzone, Homosalate, Octinoxate, Octocrylene CREAM TOPICAL 20151117 OTC MONOGRAPH FINAL part352 Allure Labs, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 30; 50; 50; 27.5 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 62742-4082_93eefb61-1e93-46aa-bd2e-016571ece454 62742-4082 HUMAN OTC DRUG Light Beam Hand Repair Cream Broad Spectrum SPF 18 Zinc Oxide CREAM TOPICAL 20160428 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE 9.45 mg/mL E 20171231 62742-4083_bc25c3b8-ecaa-4acd-bb39-9f61345b2762 62742-4083 HUMAN OTC DRUG Tinted Radiance Moisturizer Broad Spectrum SPF 32 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20160428 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE; TITANIUM DIOXIDE 60; 45 mg/mL; mg/mL E 20171231 62742-4084_068076df-bcb2-480e-bde1-71a27c67b181 62742-4084 HUMAN OTC DRUG Tinted Radiance Moisturizer Broad Spectrum SPF 32 Medium to Tan Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Allure Labs Inc. ZINC OXIDE; TITANIUM DIOXIDE 60; 45 mg/mL; mg/mL N 20181231 62742-4085_e7775255-c80d-416a-9c46-5aae770976ac 62742-4085 HUMAN OTC DRUG Tinted Radiance Moisturizer Broad Spectrum SPF 32 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20160428 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE; TITANIUM DIOXIDE 60; 45 mg/mL; mg/mL E 20171231 62742-4086_27719a77-dbd8-4ee9-8424-8479c08b0504 62742-4086 HUMAN OTC DRUG SPF 30 Mineral Sunscreen Face Neck Zinc Oxide CREAM TOPICAL 20160711 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE 186 mg/mL E 20171231 62742-4087_d29366ba-c7f0-48db-9432-24a99728127a 62742-4087 HUMAN OTC DRUG Daylight Tinted Radiance Moisturizer Broad Spectrum SPF 32 - Medium Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20170524 OTC MONOGRAPH FINAL part352 Allure Labs Inc. ZINC OXIDE; TITANIUM DIOXIDE 60; 45 mg/mL; mg/mL N 20181231 62742-4088_da4abd01-126d-468d-8665-6fe76985f314 62742-4088 HUMAN OTC DRUG Extra Light Tinted Radiance Moisturizer Broad Spectrum SPF 32 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20170524 OTC MONOGRAPH FINAL part352 Allure Labs Inc. ZINC OXIDE; TITANIUM DIOXIDE 60; 45 mg/mL; mg/mL N 20181231 62742-4091_24e37071-c31b-49b4-90be-9d40ba08f93a 62742-4091 HUMAN OTC DRUG Pain Relief Cream Trolamine Salicylate CREAM TOPICAL 20171127 OTC MONOGRAPH NOT FINAL part348 ALLURE LABS INC. TROLAMINE SALICYLATE 100 mg/g N 20181231 62742-4092_a42d6df3-47f2-4e84-a841-97836a59c159 62742-4092 HUMAN OTC DRUG DermaClear Purity Cleanser Level I Benzoyl Peroxide GEL TOPICAL 20171128 OTC MONOGRAPH FINAL part333D Allure Labs, Inc. BENZOYL PEROXIDE 25 mg/mL N 20181231 62742-4093_6ea7f26d-d404-4607-8a5d-be47c444ce99 62742-4093 HUMAN OTC DRUG DermaClear Purity Cleanser Level II Benzoyl Peroxide GEL TOPICAL 20171128 OTC MONOGRAPH FINAL part333D Allure Labs, Inc. BENZOYL PEROXIDE 50 mg/mL N 20181231 62742-4094_390b4010-fd94-43d8-9f2b-a18504ac04da 62742-4094 HUMAN OTC DRUG SheerZinc SPF 30 Tinted - SunKissed Zinc Oxide CREAM TOPICAL 20171128 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE 186 mg/g N 20181231 62742-4095_9da60d9f-0e6d-4749-ae54-d157c61038ee 62742-4095 HUMAN OTC DRUG SheerZinc SPF 30 Tinted - Tan Zinc Oxide CREAM TOPICAL 20171128 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE 186 mg/g N 20181231 62742-4096_e1333fc1-1b2f-443f-9169-262ff17ab932 62742-4096 HUMAN OTC DRUG Sun Armor SPF 50 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171129 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 86; 65 mg/g; mg/g N 20181231 62742-4097_32eb6c25-5802-4b62-8d7f-d14e1bd2326c 62742-4097 HUMAN OTC DRUG Mineral Foundation SPF 30-3W Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171129 OTC MONOGRAPH FINAL part352 Allure Labs Inc. ZINC OXIDE; TITANIUM DIOXIDE 55; 44 mg/mL; mg/mL N 20181231 62742-4099_2105dd07-3944-4eae-a33f-465460cc8688 62742-4099 HUMAN OTC DRUG Mineral Foundation SPF 30-5W Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171129 OTC MONOGRAPH FINAL part352 Allure Labs Inc. ZINC OXIDE; TITANIUM DIOXIDE 55; 44 mg/mL; mg/mL N 20181231 62742-4100_8d40f799-b3f4-4e21-ba1c-0503570a6471 62742-4100 HUMAN OTC DRUG No Makeup Foundation Fair Broad Spectrum SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171130 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 128.8; 33.7 mg/mL; mg/mL N 20181231 62742-4101_0f4c6472-65d3-448a-bf20-eae8e7cfa72b 62742-4101 HUMAN OTC DRUG No Makeup Foundation Light Broad Spectrum SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171130 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 128.8; 33.7 mg/mL; mg/mL N 20181231 62742-4102_42f26b04-3241-41b7-ba64-4a9b52f4b65d 62742-4102 HUMAN OTC DRUG No Makeup Foundation Light-Medium Broad Spectrum SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171130 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 128.8; 33.7 mg/mL; mg/mL N 20181231 62742-4103_44dbf7ac-a762-438e-96b8-4a498ee5a101 62742-4103 HUMAN OTC DRUG No Makeup Foundation Fair-Light Broad Spectrum SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171201 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 128.8; 33.7 mg/mL; mg/mL N 20181231 62742-4104_ef5ef3ec-26cd-4f12-8705-ffb6c52a8df0 62742-4104 HUMAN OTC DRUG No Makeup Foundation Tan Broad Spectrum SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171201 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 128.8; 33.7 mg/mL; mg/mL N 20181231 62742-4105_29cd4bec-183c-48ba-9904-56358c4cd027 62742-4105 HUMAN OTC DRUG No Makeup Concealer Fair Broad Spectrum SPF 35 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171201 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 59.8; 48 mg/g; mg/g N 20181231 62742-4106_29390b9d-6fc1-4934-aecd-1d93c948efb6 62742-4106 HUMAN OTC DRUG No Makeup Concealer Medium Broad Spectrum SPF 35 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171201 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 59.8; 48 mg/g; mg/g N 20181231 62742-4107_90190c04-8a2c-40ab-be29-1ff26c488935 62742-4107 HUMAN OTC DRUG Acne Cleanser W/ Salicylic Acid Salicylic Acid CREAM TOPICAL 20171201 OTC MONOGRAPH FINAL part333D Allure Labs, Inc SALICYLIC ACID 20 mg/mL N 20181231 62742-4108_d41fde52-3d9e-472f-a726-47902ad7c537 62742-4108 HUMAN OTC DRUG SheerZinc SPF 30 Tinted - Nude Zinc Oxide CREAM TOPICAL 20171128 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE 186 mg/g N 20181231 62742-4110_c67cae15-f7cf-4b02-89f1-1d2446dd1573 62742-4110 HUMAN OTC DRUG Light Tint Clear Zinc Solar Protection SPF 30 Zinc Oxide CREAM TOPICAL 20171204 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE 170 mg/g N 20181231 62742-4112_c16655f8-97fb-4694-83d3-03aef3737a43 62742-4112 HUMAN OTC DRUG Tinted Clear Zinc Solar Protection SPF 30 Zinc Oxide CREAM TOPICAL 20171204 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE 176.7 mg/g N 20181231 62742-4113_99e306cf-4b3e-4c7b-a089-e91c70872aa5 62742-4113 HUMAN OTC DRUG Acne Clarifying Cream Salicylic Acid CREAM TOPICAL 20171204 OTC MONOGRAPH FINAL part333D Allure Labs, Inc SALICYLIC ACID 20 mg/mL N 20181231 62742-4116_6c11f330-eb2f-4110-be76-15ac208411e0 62742-4116 HUMAN OTC DRUG Broad Spectrum SPF 30 for Face and Body Zinc Oxide CREAM TOPICAL 20171204 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE 186 mg/g N 20181231 62742-4117_410b0b2e-06a6-4333-8268-b3a679822435 62742-4117 HUMAN OTC DRUG Cover Recover SPF 30 Ivory Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171205 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 85; 65 mg/mL; mg/mL N 20181231 62742-4118_bcc3d467-c712-4af6-8282-866ed7ec6832 62742-4118 HUMAN OTC DRUG Cover Recover SPF 30 Cream Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171205 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 85; 65 mg/mL; mg/mL N 20181231 62742-4119_fb3ba74e-6e7e-4cc2-b618-7629c3132403 62742-4119 HUMAN OTC DRUG Cover Recover SPF 30 Beige Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171205 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 85; 65 mg/mL; mg/mL N 20181231 62742-4120_8da3afad-b561-4863-8ab5-21a117883b33 62742-4120 HUMAN OTC DRUG Cover Recover SPF 30 Cocoa Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171205 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 85; 65 mg/mL; mg/mL N 20181231 62742-4121_75a8359c-a197-4b33-a0e1-a710809a3e39 62742-4121 HUMAN OTC DRUG Cover Recover SPF 30 Tawny Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171205 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 85; 65 mg/mL; mg/mL N 20181231 62742-4122_cf2e2d00-7336-44bc-90ad-ec96d001828f 62742-4122 HUMAN OTC DRUG Cover Recover SPF 30 Warm Beige Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171205 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 85; 65 mg/mL; mg/mL N 20181231 62742-4123_eab0ec72-12d9-413b-afea-64e1bc753cd7 62742-4123 HUMAN OTC DRUG Cover Recover SPF 30 Sand Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171205 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 85; 65 mg/mL; mg/mL N 20181231 62742-4124_bc6032e6-6ffd-4cab-8ca9-c4ffacc18d80 62742-4124 HUMAN OTC DRUG Cover Recover SPF 30 Taupe Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171205 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 85; 65 mg/mL; mg/mL N 20181231 62742-4145_8e9f9e3a-6bd4-4a35-b859-ad14ff81e53b 62742-4145 HUMAN OTC DRUG Pyratine XR Creme With Sunscreen Broad Spectrum SPF30 Zinc Oxide CREAM TOPICAL 20171207 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE 186 mg/g N 20181231 62742-4146_b6ecc82b-9a28-4485-bade-18942e6afeaf 62742-4146 HUMAN OTC DRUG Clear Daylight Radiance Moisturizer Broad Spectrum SPF 32 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171207 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE; TITANIUM DIOXIDE 60; 45 mg/mL; mg/mL N 20181231 62742-4147_0bb92797-d231-49f8-a371-2395d4f1495e 62742-4147 HUMAN OTC DRUG Deep Daylight Tinted Radiance Moisturizer Broad Spectrum SPF 32 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171208 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE; TITANIUM DIOXIDE 60; 45 mg/mL; mg/mL N 20181231 62742-4148_b96708fe-3f14-455d-80cc-ee8929f8585d 62742-4148 HUMAN OTC DRUG Light Daylight Tinted Radiance Moisturizer Broad Spectrum SPF 32 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171208 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE; TITANIUM DIOXIDE 60; 45 mg/mL; mg/mL N 20181231 62742-4150_78fc6022-0ca5-4af5-9dad-09900aba46cc 62742-4150 HUMAN OTC DRUG Dark Daylight Tinted Radiance Moisturizer Broad Spectrum SPF 32 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171208 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE; TITANIUM DIOXIDE 60; 45 mg/mL; mg/mL N 20181231 62742-4152_a5fb13e4-54ec-496a-aaeb-dc387aa4ed3d 62742-4152 HUMAN OTC DRUG Mineral Sunscreen Broad Spectrum SPF 45 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171211 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 51.4; 73.6 mg/mL; mg/mL N 20181231 62742-4153_00a92501-f7cc-4f23-9d10-56e102b7ad41 62742-4153 HUMAN OTC DRUG Mineral Sunscreen Moisturizer Broad Spectrum SPF 20 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171212 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE; TITANIUM DIOXIDE 50; 48 mg/mL; mg/mL N 20181231 62742-4154_5d997894-d0e9-43f9-9b06-d3dfff865b40 62742-4154 HUMAN OTC DRUG Mineral Sunscreen Broad Spectrum SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171212 OTC MONOGRAPH FINAL part352 Allure Labs, Inc ZINC OXIDE 50 mg/mL N 20181231 62742-4157_750f7eca-6069-41c7-b52b-44817c9f7998 62742-4157 HUMAN OTC DRUG Tropical Topical Matte SPF 30 Zinc Oxide CREAM TOPICAL 20171212 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE 186 mg/g N 20181231 62742-4158_b544e097-5fb8-4c11-8ded-d2b9962d8ab0 62742-4158 HUMAN OTC DRUG Quench and Protect Hydrating SPF 30 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171212 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE; TITANIUM DIOXIDE 60; 47 mg/g; mg/g N 20181231 62742-4159_f0c8a73d-12dd-4d98-8a8f-4cf1e783d3dc 62742-4159 HUMAN OTC DRUG Everyday Sheer Coverage Light Tint SPF 20 Zinc Oxide CREAM TOPICAL 20171215 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE 177 mg/mL N 20181231 62742-4160_2308726e-469c-4d07-86f5-5e99f0315a41 62742-4160 HUMAN OTC DRUG Everyday Sheer Coverage Medium Tint SPF 20 Zinc Oxide CREAM TOPICAL 20171220 OTC MONOGRAPH FINAL part352 Allure Labs Inc ZINC OXIDE 177 mg/mL N 20181231 62742-4161_66f2df85-d6f2-4928-8e96-f2bc14f2988e 62742-4161 HUMAN OTC DRUG Sun Shield SPF 50 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20171211 OTC MONOGRAPH FINAL part352 ALLURE LABS INC ZINC OXIDE; TITANIUM DIOXIDE 86; 65 mg/mL; mg/mL N 20181231 62742-4162_94dd8ef7-cdc0-4725-82db-4853254d0643 62742-4162 HUMAN OTC DRUG Natural Protection Face and Eyes SPF 30 Zinc Oxide CREAM TOPICAL 20171218 OTC MONOGRAPH FINAL part352 ALLURE LABS INC ZINC OXIDE 189 mg/mL N 20181231 62742-4163_4c70ad4f-b396-4a94-920a-a75dcf67de8e 62742-4163 HUMAN OTC DRUG Bio Active Complex SPF 15 Zinc Oxide CREAM TOPICAL 20171218 OTC MONOGRAPH FINAL part352 ALLURE LABS INC ZINC OXIDE 120 mg/mL N 20181231 62750-001_f890bce3-903d-4dff-be4b-9f1b99660961 62750-001 HUMAN OTC DRUG Zicam Allergy Relief galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, and sulfur SPRAY NASAL 20000414 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SULFUR 30; 200; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62750-004_c3ddc814-feff-4ab2-8333-797e11323d5b 62750-004 HUMAN OTC DRUG Zicam Allergy Relief GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, and SULFUR GEL NASAL 20150215 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SULFUR 30; 200; 30; 200 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL N 20181231 62750-005_440cafb4-5643-4c11-aaa9-39cecc3cacb2 62750-005 HUMAN OTC DRUG Zicam oxymetazoline hydrochloride SPRAY NASAL 20020520 OTC MONOGRAPH FINAL part341 Matrixx Initiatives, Inc. OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 62750-006_63620466-15bf-4202-b159-2aa22f1d1140 62750-006 HUMAN OTC DRUG Zicam oxymetazoline hydrochloride SPRAY NASAL 20020529 OTC MONOGRAPH FINAL part341 Matrixx Initiatives, Inc. OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 62750-027_aa67c595-8f4e-40ca-bc90-a25a857c456a 62750-027 HUMAN OTC DRUG Zicam Naturals Cough Suppressant mentha piperita LIQUID ORAL 20110101 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. MENTHA PIPERITA 3 [hp_X]/188mL N 20181231 62750-037_4e1f5875-b981-49f5-8dd5-c6218919118d 62750-037 HUMAN OTC DRUG Zicam Cold Remedy Kids Soft Chews ZINC ACETATE ANHYDROUS and ZINC GLUCONATE BAR, CHEWABLE ORAL 20140801 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 2 [hp_X]/1; [hp_X]/1 N 20181231 62750-043_b0836f70-64d4-4521-acb5-7a4b12120d2c 62750-043 HUMAN OTC DRUG Zicam Cold Remedy Rapidmelts with Echinacea ZINC ACETATE ANHYDROUS, ECHINACEA ANGUSTIFOLIA, and ZINC GLUCONATE TABLET ORAL 20111001 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ECHINACEA ANGUSTIFOLIA; ZINC GLUCONATE 2; 5; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62750-044_d7bcec2a-eff8-4f74-a2b0-bc6e22237ce2 62750-044 HUMAN OTC DRUG Zicam Cold Remedy Rapidmelts Citrus ZINC ACETATE ANHYDROUS and ZINC GLUCONATE TABLET ORAL 20111001 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 62750-054_3b51c12a-78b7-4ba9-9a38-2609028e99f4 62750-054 HUMAN OTC DRUG Zicam Cold Remedy Rapidmelts ZINC ACETATE ANHYDROUS and ZINC GLUCONATE TABLET ORAL 20120801 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 62750-055_612a587a-012c-4208-885c-202be4f20f6f 62750-055 HUMAN OTC DRUG Zicam Cold Remedy Ultra Rapidmelts zinc acetate and zinc gluconate TABLET ORAL 20130214 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 62750-056_9f95ee3c-0bf1-454a-a4c7-a7dc5b405f37 62750-056 HUMAN OTC DRUG Zicam Cold Remedy Ultra Rapidmelts zinc acetate and zinc gluconate TABLET ORAL 20130214 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 62750-060_865dfe2a-4963-45ed-b6b5-0f8aaa0d10f0 62750-060 HUMAN OTC DRUG Zicam Cold Remedy Oral Mist ZINC ACETATE and ZINC GLUCONATE SPRAY ORAL 20130301 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/mL; [hp_X]/mL N 20181231 62750-070_22a75417-84be-439c-964a-6f148a084909 62750-070 HUMAN OTC DRUG Zicam Cold Remedy GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT, and SCHOENOCAULON OFFICINALE SEED SPRAY NASAL 20140801 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 4; 4; 4 [hp_X]/.56mL; [hp_X]/.56mL; [hp_X]/.56mL N 20181231 62750-073_6916a801-55cd-461d-b813-5ae5133f739f 62750-073 HUMAN OTC DRUG Zicam Cold Remedy GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT, and SCHOENOCAULON OFFICINALE SEED GEL NASAL 20150228 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED 4; 4; 4 [hp_X]/1.2mL; [hp_X]/1.2mL; [hp_X]/1.2mL N 20181231 62750-075_44f686a4-0853-47a1-8de2-942595bd8bc1 62750-075 HUMAN OTC DRUG Zicam Cold Remedy Ultra zinc acetate anhydrous, zinc gluconate, and sambucus nigra flowering top CRYSTAL ORAL 20151201 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE; SAMBUCUS NIGRA FLOWERING TOP 2; 1; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 62750-077_e293fabf-994d-4477-bea4-5431e62b80a6 62750-077 HUMAN OTC DRUG Zicam Cold Remedy Medicated Fruit Drops ZINC ACETATE ANHYDROUS and ZINC GLUCONATE BAR, CHEWABLE ORAL 20170401 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 2 [hp_X]/1; [hp_X]/1 N 20181231 62750-079_eaf21fd3-c29c-44db-ba87-bc3ebf03c4e8 62750-079 HUMAN OTC DRUG Zicam Cold Remedy ZINC ACETATE ANHYDROUS and ZINC GLUCONATE LOZENGE ORAL 20180201 UNAPPROVED HOMEOPATHIC Matrixx Initiatives, Inc. ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 2 [hp_X]/1; [hp_X]/1 N 20191231 62756-015_2604bb87-dcdf-4faf-87a4-bcae55fcb40e 62756-015 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20130617 ANDA ANDA201720 Sun Pharmaceutical Industries Limited TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 62756-016_2604bb87-dcdf-4faf-87a4-bcae55fcb40e 62756-016 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20130617 ANDA ANDA201720 Sun Pharmaceutical Industries Limited TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 62756-017_2604bb87-dcdf-4faf-87a4-bcae55fcb40e 62756-017 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION, SOLUTION INTRAMUSCULAR 20130617 ANDA ANDA201720 Sun Pharmaceutical Industries Limited TESTOSTERONE CYPIONATE 100 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 62756-130_1534c133-935e-41c6-96e1-74dfeed93790 62756-130 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Sun Pharmaceutical Industries Limited ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 62756-131_1534c133-935e-41c6-96e1-74dfeed93790 62756-131 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Sun Pharmaceutical Industries Limited ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 62756-142_b98b61db-b800-4b0f-99cb-6365356a1a36 62756-142 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Sun Pharmaceutical Industries Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 62756-143_b98b61db-b800-4b0f-99cb-6365356a1a36 62756-143 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Sun Pharmaceutical Industries Limited METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 62756-145_67688114-8877-4986-8e49-4a7a66e996bc 62756-145 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077131 Sun Pharmaceutical Industries Limited RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 62756-146_67688114-8877-4986-8e49-4a7a66e996bc 62756-146 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077131 Sun Pharmaceutical Industries Limited RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 62756-147_67688114-8877-4986-8e49-4a7a66e996bc 62756-147 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077131 Sun Pharmaceutical Industries Limited RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 62756-148_67688114-8877-4986-8e49-4a7a66e996bc 62756-148 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077131 Sun Pharmaceutical Industries Limited RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 62756-160_ffcded64-7b8b-48fb-8694-3b3ba1f81c24 62756-160 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 Sun Pharmaceutical Industries Limited TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 62756-161_7f3fe422-471d-4136-82ef-8a5c1c9451ef 62756-161 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate SOLUTION NASAL 20120414 ANDA ANDA077212 Sun Pharmaceutical Industries Limited DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 62756-183_a4a797fd-5c59-45b9-8e88-263509e488f7 62756-183 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Sun Pharmaceutical Industries Limited OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 62756-184_a4a797fd-5c59-45b9-8e88-263509e488f7 62756-184 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Sun Pharmaceutical Industries Limited OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 62756-185_a4a797fd-5c59-45b9-8e88-263509e488f7 62756-185 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Sun Pharmaceutical Industries Limited OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 62756-186_9d9c6786-fa0c-49c8-9e07-889d50d67f2a 62756-186 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, ORALLY DISINTEGRATING ORAL 20090814 ANDA ANDA078690 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 62756-187_9d9c6786-fa0c-49c8-9e07-889d50d67f2a 62756-187 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, ORALLY DISINTEGRATING ORAL 20090814 ANDA ANDA078690 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 62756-188_9d9c6786-fa0c-49c8-9e07-889d50d67f2a 62756-188 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, ORALLY DISINTEGRATING ORAL 20090814 ANDA ANDA078690 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 62756-194_648b3dac-a44d-4980-96ea-85cd05dfb9fa 62756-194 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20150617 ANDA ANDA204293 Sun Pharmaceutical Industries Limited DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 62756-200_4ddc4028-7507-4f27-acaf-6f20c6cdc8b1 62756-200 HUMAN PRESCRIPTION DRUG TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111104 ANDA ANDA077555 Sun Pharmaceutical Industries Limited TIAGABINE HYDROCHLORIDE 2 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 62756-202_55e62f9c-ff35-494d-aa1b-ed759bc59512 62756-202 HUMAN PRESCRIPTION DRUG gabapentin gabapentin TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Sun Pharmaceutical Industries Limited GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 62756-204_55e62f9c-ff35-494d-aa1b-ed759bc59512 62756-204 HUMAN PRESCRIPTION DRUG gabapentin gabapentin TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Sun Pharmaceutical Industries Limited GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 62756-218_35f7e448-c7e8-4e01-96db-c6e1af16339f 62756-218 HUMAN PRESCRIPTION DRUG IBANDRONATE SODIUM IBANDRONATE SODIUM INJECTION, SOLUTION INTRAVENOUS 20140215 ANDA ANDA090853 Sun Pharmaceutical Industries Limited IBANDRONATE SODIUM 3 mg/3mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 62756-224_4ddc4028-7507-4f27-acaf-6f20c6cdc8b1 62756-224 HUMAN PRESCRIPTION DRUG TIAGABINE HYDROCHLORIDE TIAGABINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20111104 ANDA ANDA077555 Sun Pharmaceutical Industries Limited TIAGABINE HYDROCHLORIDE 4 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 62756-240_1534c133-935e-41c6-96e1-74dfeed93790 62756-240 HUMAN PRESCRIPTION DRUG ondansetron ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Sun Pharmaceutical Industries Limited ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 62756-258_62fb6a2d-0189-4d1f-a594-427ce18fe3d8 62756-258 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060317 ANDA ANDA077634 Sun Pharmaceutical Industries Limited ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62756-259_62fb6a2d-0189-4d1f-a594-427ce18fe3d8 62756-259 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060317 ANDA ANDA077634 Sun Pharmaceutical Industries Limited ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62756-260_62fb6a2d-0189-4d1f-a594-427ce18fe3d8 62756-260 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060317 ANDA ANDA077634 Sun Pharmaceutical Industries Limited ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62756-293_ec678657-42f1-4a51-a596-129033e2ff60 62756-293 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Sun Pharmaceutical Industries Limited CEPHALEXIN 250 mg/1 E 20171231 62756-294_ec678657-42f1-4a51-a596-129033e2ff60 62756-294 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Sun Pharmaceutical Industries Limited CEPHALEXIN 500 mg/1 E 20171231 62756-299_aec9ee7e-b8ad-41d6-8a7c-2be6dabfdaa5 62756-299 HUMAN PRESCRIPTION DRUG phenytoin sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20080630 ANDA ANDA040731 Sun Pharmaceutical Industries Limited PHENYTOIN SODIUM 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 62756-310_461bf92c-0ad0-4e99-8542-6dc6bfbde5f1 62756-310 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET, FILM COATED ORAL 20090618 ANDA ANDA090800 Sun Pharmaceutical Industries Limited QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 62756-311_461bf92c-0ad0-4e99-8542-6dc6bfbde5f1 62756-311 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET, FILM COATED ORAL 20090618 ANDA ANDA090800 Sun Pharmaceutical Industries Limited QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 62756-312_461bf92c-0ad0-4e99-8542-6dc6bfbde5f1 62756-312 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET, FILM COATED ORAL 20090618 ANDA ANDA090800 Sun Pharmaceutical Industries Limited QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 62756-313_461bf92c-0ad0-4e99-8542-6dc6bfbde5f1 62756-313 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET, FILM COATED ORAL 20090618 ANDA ANDA090800 Sun Pharmaceutical Industries Limited QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 62756-329_0a32f2e8-ff26-49c3-9d42-d9872ad65176 62756-329 HUMAN PRESCRIPTION DRUG EPINASTINE HYDROCHLORIDE EPINASTINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20111101 ANDA ANDA091626 Sun Pharmaceutical Industries Limited EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 62756-356_1534c133-935e-41c6-96e1-74dfeed93790 62756-356 HUMAN PRESCRIPTION DRUG ondansetron ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Sun Pharmaceutical Industries Limited ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 62756-402_5a28d526-d6d1-4bce-b478-7e9ff11803e5 62756-402 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20061212 ANDA ANDA040621 Sun Pharmaceutical Industries Limited PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 62756-430_81bf4506-63ac-45da-bcff-fb329a95e6c9 62756-430 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 20100708 ANDA ANDA091027 Sun Pharmaceutical Industries Limited LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 62756-432_aec9ee7e-b8ad-41d6-8a7c-2be6dabfdaa5 62756-432 HUMAN PRESCRIPTION DRUG phenytoin sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20080630 ANDA ANDA040731 Sun Pharmaceutical Industries Limited PHENYTOIN SODIUM 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 62756-446_dd702835-7381-4f3e-bf3a-65266be02aa8 62756-446 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 20190331 ANDA ANDA040755 Sun Pharmaceutical Industries Limited CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 62756-457_f6fc685f-6d03-48b4-9851-65a4fc8476f0 62756-457 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE ORAL 20070823 ANDA ANDA077828 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 62756-459_c9c684af-354a-432f-afee-dbf5cce1a701 62756-459 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine TABLET SUBLINGUAL 20160217 ANDA ANDA201760 Sun Pharmaceutical Industries Limited BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 62756-460_c9c684af-354a-432f-afee-dbf5cce1a701 62756-460 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine TABLET SUBLINGUAL 20160217 ANDA ANDA201760 Sun Pharmaceutical Industries Limited BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 62756-461_f6fc685f-6d03-48b4-9851-65a4fc8476f0 62756-461 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE ORAL 20070823 ANDA ANDA077828 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 62756-508_c1aee218-5681-4f2e-9fd5-c356b0f81e41 62756-508 HUMAN PRESCRIPTION DRUG Esomeprazole Sodium Esomeprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141215 ANDA ANDA200882 Sun Pharmaceutical Industries Limited ESOMEPRAZOLE SODIUM 20 mg/5mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 62756-509_c1aee218-5681-4f2e-9fd5-c356b0f81e41 62756-509 HUMAN PRESCRIPTION DRUG Esomeprazole Sodium Esomeprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141215 ANDA ANDA200882 Sun Pharmaceutical Industries Limited ESOMEPRAZOLE SODIUM 40 mg/5mL Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 62756-511_caa42adc-a41b-486c-8b97-9e8ed3213bda 62756-511 HUMAN PRESCRIPTION DRUG LETROZOLE LETROZOLE TABLET, FILM COATED ORAL 20150909 20190331 ANDA ANDA091466 Sun Pharmaceutical Industries Limited LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 62756-512_c0094d19-b077-46ba-86e6-02b343a4f874 62756-512 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130403 ANDA ANDA090923 Sun Pharmaceutical Industries Limited AZITHROMYCIN MONOHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 62756-517_3fd359c4-1d2b-4268-af37-9005c0f4f333 62756-517 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20081028 ANDA ANDA078536 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 62756-518_3fd359c4-1d2b-4268-af37-9005c0f4f333 62756-518 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20081028 ANDA ANDA078536 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 62756-519_3fd359c4-1d2b-4268-af37-9005c0f4f333 62756-519 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20081028 ANDA ANDA078536 Sun Pharmaceutical Industries Limited CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 62756-520_bdef3baf-cbf3-4025-a8b9-f67ca613b4ea 62756-520 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA078295 Sun Pharmaceutical Industries Limited SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 62756-521_bdef3baf-cbf3-4025-a8b9-f67ca613b4ea 62756-521 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA078295 Sun Pharmaceutical Industries Limited SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 62756-522_bdef3baf-cbf3-4025-a8b9-f67ca613b4ea 62756-522 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA078295 Sun Pharmaceutical Industries Limited SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 62756-523_92946a6c-8da6-42cf-b407-1cd12c4199ba 62756-523 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET, FILM COATED ORAL 20101124 ANDA ANDA078359 Sun Pharmaceutical Industries Limited DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 62756-529_b844ffe0-0b30-4d3b-8a16-1a6da45d9e28 62756-529 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20130130 ANDA ANDA091280 Sun Pharmaceutical Industries Limited DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 62756-529_fe90dd4d-c54b-4fce-b5d0-b9f3fa69d2e3 62756-529 HUMAN PRESCRIPTION DRUG desmopressin acetate desmopressin acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140220 ANDA ANDA091280 Sun Pharmaceutical Industries Limited DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 62756-538_df99ee88-1056-4d3e-8c84-2cf8696dee40 62756-538 HUMAN PRESCRIPTION DRUG Riluzole Riluzole TABLET, FILM COATED ORAL 20130618 ANDA ANDA091417 Sun Pharmaceutical Industries Limited RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] N 20181231 62756-542_8143d0f9-42bb-4030-91d5-bb2ae54814c7 62756-542 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120206 ANDA ANDA091567 Sun Pharmaceutical Industries Limited FEXOFENADINE HYDROCHLORIDE 30 mg/1 N 20181231 62756-542_c58ff1bc-e9b9-4ec5-87b1-64a102d19405 62756-542 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120206 ANDA ANDA091567 Sun Pharmaceutical Industries Limited FEXOFENADINE HYDROCHLORIDE 30 mg/1 N 20181231 62756-543_8143d0f9-42bb-4030-91d5-bb2ae54814c7 62756-543 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120206 ANDA ANDA091567 Sun Pharmaceutical Industries Limited FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 62756-543_c58ff1bc-e9b9-4ec5-87b1-64a102d19405 62756-543 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120206 ANDA ANDA091567 Sun Pharmaceutical Industries Limited FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 62756-545_8143d0f9-42bb-4030-91d5-bb2ae54814c7 62756-545 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120206 ANDA ANDA091567 Sun Pharmaceutical Industries Limited FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 62756-545_c58ff1bc-e9b9-4ec5-87b1-64a102d19405 62756-545 HUMAN OTC DRUG FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120206 ANDA ANDA091567 Sun Pharmaceutical Industries Limited FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 62756-551_8368d14d-b9cb-416f-b581-b1029bb14baa 62756-551 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 20180430 ANDA ANDA091038 Sun Pharmaceutical Industries Limited OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 62756-552_8368d14d-b9cb-416f-b581-b1029bb14baa 62756-552 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 20180430 ANDA ANDA091038 Sun Pharmaceutical Industries Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 62756-553_8368d14d-b9cb-416f-b581-b1029bb14baa 62756-553 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 20180630 ANDA ANDA091038 Sun Pharmaceutical Industries Limited OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 62756-554_8368d14d-b9cb-416f-b581-b1029bb14baa 62756-554 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 20180430 ANDA ANDA091038 Sun Pharmaceutical Industries Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 62756-555_8368d14d-b9cb-416f-b581-b1029bb14baa 62756-555 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 20180430 ANDA ANDA091038 Sun Pharmaceutical Industries Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 62756-556_8368d14d-b9cb-416f-b581-b1029bb14baa 62756-556 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 20180430 ANDA ANDA091038 Sun Pharmaceutical Industries Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 62756-581_2a527ed0-3af2-41eb-9e8f-5b4783b37259 62756-581 HUMAN PRESCRIPTION DRUG AMIFOSTINE AMIFOSTINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080314 ANDA ANDA077126 Sun Pharmaceutical Industries Limited AMIFOSTINE 50 mg/mL E 20171231 62756-707_20dec064-8e85-422f-a757-8b20bbd61a0a 62756-707 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Sun Pharmaceutical Industries Limited TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 62756-710_20dec064-8e85-422f-a757-8b20bbd61a0a 62756-710 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Sun Pharmaceutical Industries Limited TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 62756-711_20dec064-8e85-422f-a757-8b20bbd61a0a 62756-711 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Sun Pharmaceutical Industries Limited TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 62756-712_20dec064-8e85-422f-a757-8b20bbd61a0a 62756-712 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Sun Pharmaceutical Industries Limited TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 62756-718_5ab650aa-b7a2-459a-9498-7584c99bda77 62756-718 HUMAN OTC DRUG Opcicon One-Step levonorgestrel TABLET ORAL 20140912 ANDA ANDA202635 Sun Pharmaceutical Industries Limited LEVONORGESTREL 1.5 mg/1 N 20181231 62756-720_b0e319f8-139c-4722-a67f-aebe0a63517c 62756-720 HUMAN OTC DRUG My Choice TM levonorgestrel TABLET ORAL 20170512 ANDA ANDA202635 Sun Pharmaceutical Industries Limited LEVONORGESTREL 1.5 mg/1 N 20181231 62756-751_8368d14d-b9cb-416f-b581-b1029bb14baa 62756-751 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120228 20180331 ANDA ANDA090881 Sun Pharmaceutical Industries Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 62756-754_8368d14d-b9cb-416f-b581-b1029bb14baa 62756-754 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120228 20180430 ANDA ANDA090881 Sun Pharmaceutical Industries Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 62756-755_8368d14d-b9cb-416f-b581-b1029bb14baa 62756-755 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120228 20180531 ANDA ANDA090881 Sun Pharmaceutical Industries Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 62756-757_8368d14d-b9cb-416f-b581-b1029bb14baa 62756-757 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120228 20180531 ANDA ANDA090881 Sun Pharmaceutical Industries Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 62756-796_48bc639b-9e67-41b9-a5c8-68227a1b8c94 62756-796 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Sun Pharmaceutical Industries Limited DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 62756-797_48bc639b-9e67-41b9-a5c8-68227a1b8c94 62756-797 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Sun Pharmaceutical Industries Limited DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 62756-798_48bc639b-9e67-41b9-a5c8-68227a1b8c94 62756-798 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Sun Pharmaceutical Industries Limited DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 62756-826_90644999-157b-40d5-8307-e8caf8a885a2 62756-826 HUMAN PRESCRIPTION DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20120220 ANDA ANDA091418 Sun Pharmaceutical Industries Limited DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 62756-827_90644999-157b-40d5-8307-e8caf8a885a2 62756-827 HUMAN PRESCRIPTION DRUG DOXOrubicin Hydrochloride DOXOrubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20120220 ANDA ANDA091418 Sun Pharmaceutical Industries Limited DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] E 20171231 62756-915_873a7c4b-f995-44b8-8006-7b03b2eb1453 62756-915 HUMAN OTC DRUG Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120929 ANDA ANDA090922 Sun Pharmaceutical Industries Limited CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 62756-969_a21f9e4f-b692-464b-bccd-7034c31249df 62756-969 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone Buprenorphine and Naloxone TABLET SUBLINGUAL 20170718 ANDA ANDA201633 Sun Pharmaceutical Industries Limited BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 62756-970_a21f9e4f-b692-464b-bccd-7034c31249df 62756-970 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone Buprenorphine and Naloxone TABLET SUBLINGUAL 20170718 ANDA ANDA201633 Sun Pharmaceutical Industries Limited BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 62785-001_ff6d9ee9-c90d-46be-b4c3-7fd150d3883c 62785-001 HUMAN OTC DRUG WATERMELON FROST SORE THROAT MENTHOL SPRAY ORAL 20140328 OTC MONOGRAPH NOT FINAL part356 GUILIN SANJIN PHARMACEUTICAL CO., LTD. MENTHOL 2 g/100mL N 20181231 62789-0001_b3fe379f-a4c2-4564-8caf-e58b4f52df6d 62789-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040101 UNAPPROVED MEDICAL GAS THH Acquisition LLC I dba Total Home Health OXYGEN 99 L/100L E 20171231 62795-1003_c593cdc5-963a-428a-a44d-d14dabb97d6e 62795-1003 HUMAN OTC DRUG BHI Bodypure .ALPHA.-LIPOIC ACID, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, CAFFEINE, CHOLESTEROL, JUGLANS REGIA FLOWERING TOP, STRYCHNOS NUX-VOMICA SEED, KEROSENE, FRANGULA PURSHIANA BARK, RICINUS COMMUNIS SEED, SOLIDAGO VIRGAUREA FLOWERING TOP, URTICA URENS, VIOLA TRICOLOR, and ALCOHOL, X-RAY EXPOSED (1000 RAD) TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc .ALPHA.-LIPOIC ACID; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CAFFEINE; CHOLESTEROL; JUGLANS REGIA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; KEROSENE; FRANGULA PURSHIANA BARK; RICINUS COMMUNIS SEED; SOLIDAGO VIRGAUREA FLOWERING TOP; URTICA URENS; VIOLA TRICOLOR; ALCOHOL, X-RAY EXPOSED (1000 RAD) 3; 3; 6; 6; 10; 6; 30; 12; 6; 3; 4; 6; 4; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20191231 62795-1004_f89fb44c-7487-48cf-872f-860eea7aa338 62795-1004 HUMAN OTC DRUG BHI Nausea SEMECARPUS ANACARDIUM JUICE, SILVER NITRATE, ACTIVATED CHARCOAL, IPECAC,IODINE, ROBINIA PSEUDOACACIA BARK, and SEPIA OFFICINALIS JUICE TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC MediNatura Inc SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ACTIVATED CHARCOAL; IPECAC; IODINE; ROBINIA PSEUDOACACIA BARK; SEPIA OFFICINALIS JUICE 6; 8; 12; 6; 12; 10; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1005_9821fce2-b70c-4c2e-a8cf-b3c62aa5f541 62795-1005 HUMAN OTC DRUG BHI Constipation DIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, and STRYCHNOS NUX-VOMICA SEED TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc DIOSCOREA VILLOSA TUBER; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED 4; 200; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1006_b8b1a3de-3ecd-4f9b-bab2-c766117887aa 62795-1006 HUMAN OTC DRUG BHI Calming MATRICARIA RECUTITA, ARABICA COFFEE BEAN, HOPS, STRYCHNOS IGNATII SEED, MOSCHUS MOSCHIFERUS MUSK SAC RESIN, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA FLOWERING TOP, SULFUR, VALERIAN, and VERATRUM ALBUM ROOT TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc MATRICARIA RECUTITA; ARABICA COFFEE BEAN; HOPS; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; SULFUR; VALERIAN; VERATRUM ALBUM ROOT 2; 10; 2; 8; 10; 30; 2; 12; 2; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20191231 62795-1007_038363f6-8cc5-41ec-87ef-06eebdf0cbb9 62795-1007 HUMAN OTC DRUG BHI Back AMMONIUM CHLORIDE, MATRICARIA RECUTITA,CITRULLUS COLOCYNTHIS FRUIT PULP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, and TOXICODENDRON PUBESCENS LEAF TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc AMMONIUM CHLORIDE; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; GELSEMIUM SEMPERVIRENS ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF 6; 10; 5; 6; 5; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1008_c7ec1beb-9c06-4975-95b2-bbb3cab202a3 62795-1008 HUMAN OTC DRUG BHI Flu Plus ACONITUM NAPELLUS, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, BRYONIA ALBA WHOLE, EUPATORIUM PERFOLIATUM FLOWERING TOP, IPECAC, LACHESIS MUTA VENOM,PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, ZINC GLUCONATE, AND ZINC TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC MediNatura Inc ACONITUM NAPELLUS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; BRYONIA ALBA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; IPECAC; LACHESIS MUTA VENOM; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; ZINC GLUCONATE; ZINC 4; 200; 4; 4; 6; 12; 8; 6; 8; 3; 3 [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20191231 62795-1009_4eafabc8-8d8e-4004-8679-d09e99c1d406 62795-1009 HUMAN OTC DRUG BHI Arnica Plus ARNICA MONTANA ROOT TABLET ORAL 20140930 UNAPPROVED HOMEOPATHIC MediNatura Inc. ARNICA MONTANA ROOT 6 [hp_X]/1 N 20181231 62795-1010_6bcf57e1-12af-4922-8686-39b57bb2a10a 62795-1010 HUMAN OTC DRUG BHI Arthritis ARNICA MONTANA ROOT, BERBERIS VULGARIS ROOT BARK, BRYONIA ALBA WHOLE, CAUSTICUM, CITRULLUS COLOCYNTHIS FRUIT PULP, SOLANUM DULCAMARA TOP, FERROSOFERRIC PHOSPHATE, LEDUM PALUSTRE TWIG, LYCOPODIUM CLAVATUM SPORE, RANUNCULUS BULBOSUS, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAF , and SULFUR TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC MediNatura Inc ARNICA MONTANA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA WHOLE; CAUSTICUM; CITRULLUS COLOCYNTHIS FRUIT PULP; SOLANUM DULCAMARA TOP; FERROSOFERRIC PHOSPHATE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; RANUNCULUS BULBOSUS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; SULFUR 6; 8; 4; 4; 5; 6; 12; 6; 10; 8; 6; 4; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1011_dbf3539d-2fb4-4615-bf20-c668b84fc9c3 62795-1011 HUMAN OTC DRUG BHI Allergy ANTIMONY TRISULFIDE, ARNICA MONTANA ROOT, FORMIC ACID, GRAPHITE, HISTAMINE DIHYDROCHLORIDE,STRYCHNOS IGNATII SEED, ARCTIUM LAPPA ROOT, LEDUM PALUSTRE TWIG, LYCOPODIUM CLAVATUM SPORE, PINE TAR, SELENIUM, SULFUR, SULFURIC ACID, TELLURIUM, THUJA OCCIDENTALIS LEAFY TWIG TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura ANTIMONY TRISULFIDE; ARNICA MONTANA ROOT; FORMIC ACID; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; STRYCHNOS IGNATII SEED; ARCTIUM LAPPA ROOT; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PINE TAR; SELENIUM; SULFUR; SULFURIC ACID; TELLURIUM; THUJA OCCIDENTALIS LEAFY TWIG 10; 6; 8; 10; 8; 6; 8; 8; 6; 10; 12; 12; 30; 10; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1012_41e9be16-0073-4ff5-b078-44cbe374f6c6 62795-1012 HUMAN OTC DRUG Mucus Relief ANTIMONY POTASSIUM TARTRATE, ATROPA BELLADONNA, BRYONIA ALBA WHOLE, ANEMONE AMERICANA, HYOSCYAMUS NIGER, IPECAC, LOBELIA INFLATA, HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED, and LOBARIA PULMONARIA TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC MediNatura Inc ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BRYONIA ALBA WHOLE; ANEMONE AMERICANA; HYOSCYAMUS NIGER; IPECAC; LOBELIA INFLATA; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; LOBARIA PULMONARIA 5; 6; 6; 6; 5; 6; 4; 30; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1013_1ec90917-9ae5-4a8f-98cc-96a0071edd37 62795-1013 HUMAN OTC DRUG BHI Acne SILVER NITRATE, ARNICA MONTANA, ATROPA BELLADONNA, BRYONIA ALBA ROOT, SOLANUM DULCAMARA TOP, ECHINACEA PURPUREA, CALCIUM SULFIDE, LACHESIS MUTA VENOM, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, RANCID BEEF, TOXICODENDRON PUBESCENS LEAF, and THUJA OCCIDENTALIS LEAFY TWIG TABLET ORAL 20140930 UNAPPROVED HOMEOPATHIC MediNatura SILVER NITRATE; ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; SOLANUM DULCAMARA TOP; ECHINACEA PURPUREA; CALCIUM SULFIDE; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; THUJA OCCIDENTALIS LEAFY TWIG 8; 8; 4; 5; 6; 2; 10; 12; 6; 6; 12; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1014_375887d5-ccc0-42be-9f5b-96cbf87bd2c2 62795-1014 HUMAN OTC DRUG BHI Throat SILVER NITRATE, ARNICA MONTANA ROOT, ARISAEMA TRIPHYLLUM ROOT, OYSTER SHELL CALCIUM CARBONATE, CRUDE,ACTIVATED CHARCOAL, CAUSTICUM, HYOSCYAMUS NIGER, PARIS QUADRIFOLIA, PHOSPHORUS, and VERBASCUM THAPSUS TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC MediNatura Inc SILVER NITRATE; ARNICA MONTANA ROOT; ARISAEMA TRIPHYLLUM ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; CAUSTICUM; HYOSCYAMUS NIGER; PARIS QUADRIFOLIA; PHOSPHORUS; VERBASCUM THAPSUS 6; 8; 4; 30; 10; 6; 6; 5; 10; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1015_d176363a-f620-4e40-88d0-c00bc773c936 62795-1015 HUMAN OTC DRUG BHI Spasm Pain ATROPINE SULFATE, ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, and CUPRIC SULFATE TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC MediNatura Inc ATROPINE SULFATE; ACONITUM NAPELLUS; BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC SULFATE 6; 4; 4; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1016_ca52cf63-1566-4cdd-a9b9-84deca220822 62795-1016 HUMAN OTC DRUG BHI Skin BERBERIS VULGARIS ROOT BARK, GRAPHITE, HYDROFLUORIC ACID, LYCOPODIUM CLAVATUM SPORE, PETROLATUM, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, and SULFUR TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC MediNatura Inc BERBERIS VULGARIS ROOT BARK; GRAPHITE; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE; PETROLATUM; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SULFUR 6; 10; 10; 12; 10; 8; 10; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1017_1d401ceb-8712-408f-bafa-f4f07e9ea495 62795-1017 HUMAN OTC DRUG BHI Sinus EUPHORBIA RESINIFERA RESIN, GOLDENSEAL, POTASSIUM DICHROMATE, POTASSIUM IODIDE, PHOSPHORUS, PULSATILLA VULGARIS, and THUJA OCCIDENTALIS LEAFY TWIG TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC MediNatura Inc EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM IODIDE; PHOSPHORUS; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 8; 8; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1018_3240778f-e361-4269-885b-99c2b43ef41e 62795-1018 HUMAN OTC DRUG BHI Restore ARNICA MONTANA ROOT, ILEX AQUIFOLIUM FLOWERING TOP, NERIUM OLEANDER LEAF, OVIS ARIES TESTICLE, and LACTIC ACID, L- TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC Medinatura Inc ARNICA MONTANA ROOT; ILEX AQUIFOLIUM FLOWERING TOP; NERIUM OLEANDER LEAF; OVIS ARIES TESTICLE; LACTIC ACID, L- 7; 2; 5; 10; 11 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1019_9909152d-37f3-49c3-b814-911a69c55729 62795-1019 HUMAN OTC DRUG BHI Migraine ACETIC ACID, ARANEUS DIADEMATUS, ASAFETIDA, BRYONIA ALBA WHOLE, TRIBASIC CALCIUM PHOSPHATE, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, MARSDENIA CONDURANGO BARK, TUBOCURARINE CHLORIDE, KALMIA LATIFOLIA LEAF, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, PHOSPHORIC ACID, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, and SILICON DIOXIDE TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC MediNatura Inc ACETIC ACID; ARANEUS DIADEMATUS; ASAFETIDA; BRYONIA ALBA WHOLE; TRIBASIC CALCIUM PHOSPHATE; ACTIVATED CHARCOAL; CINCHONA OFFICINALIS BARK; MARSDENIA CONDURANGO BARK; TUBOCURARINE CHLORIDE; KALMIA LATIFOLIA LEAF; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; PHOSPHORIC ACID; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; STRYCHNINE NITRATE 6; 8; 6; 30; 10; 10; 4; 4; 10; 8; 6; 6; 6; 4; 6; 10; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1020_f1f1a3a8-eab1-4de7-94be-226574cc8915 62795-1020 HUMAN OTC DRUG BHI Hemorrhoid HORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, and SULFUR TABLET ORAL 20150101 UNAPPROVED HOMEOPATHIC MediNatura Inc HORSE CHESTNUT; ALOE; COLLINSONIA CANADENSIS ROOT; VERONICASTRUM VIRGINICUM ROOT; HYDROCHLORIC ACID; STRYCHNOS NUX-VOMICA SEED; PAEONIA OFFICINALIS ROOT; SULFUR 4; 4; 4; 6; 6; 5; 6; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1021_ad0fe8a1-c499-49c6-aa0d-096fa4a86117 62795-1021 HUMAN OTC DRUG BHI Diarrhea ALOE, ACTIVATED CHARCOAL, CITRULLUS COLOCYNTHIS FRUIT PULP, CUPRIC ACETATE, FERRUM PHOSPHORICUM, PODOPHYLLUM, POTENTILLA ERECTA ROOT, and VERATRUM ALBUM ROOT TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc ALOE; ACTIVATED CHARCOAL; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC ACETATE; FERRUM PHOSPHORICUM; PODOPHYLLUM; POTENTILLA ERECTA ROOT; VERATRUM ALBUM ROOT 4; 12; 6; 6; 10; 6; 4; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1022_8036dc3e-7dbc-4006-b42d-ab58cbab2020 62795-1022 HUMAN OTC DRUG BHI Cough ANTIMONY POTASSIUM TARTRATE, ATROPA BELLADONNA, BLATTA ORIENTALIS, BRYONIA ALBA WHOLE, ANEMONE AMERICANA, STAR ANISE, IPECAC, LOBELIA INFLATA, NAPHTHALENE, SODIUM SULFIDE NONAHYDRATE, ASPIDOSPERMA QUEBRACHO-BLANCO BARK, and STACHYS OFFICINALIS TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc ANTIMONY POTASSIUM TARTRATE; ATROPA BELLADONNA; BLATTA ORIENTALIS; BRYONIA ALBA WHOLE; ANEMONE AMERICANA; STAR ANISE; IPECAC; LOBELIA INFLATA; NAPHTHALENE; SODIUM SULFIDE NONAHYDRATE; STACHYS OFFICINALIS; ASPIDOSPERMA QUEBRACHO-BLANCO BARK 6; 6; 8; 8; 5; 4; 4; 5; 6; 6; 4; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1023_28b4d665-6be7-4d11-a1eb-f79fe71c5a46 62795-1023 HUMAN OTC DRUG BHI Cold PULSATILLA VULGARIS and SULFUR TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc PULSATILLA VULGARIS; SULFUR 6; 8 [hp_X]/1; [hp_X]/1 E 20171231 62795-1024_73370c5d-9c0d-421e-bbaa-ff93d65756b0 62795-1024 HUMAN OTC DRUG WellMind Calming AVENA SATIVA FLOWERING TOP, ARABICA COFFEE BEAN, PASSIFLORA INCARNATA FLOWERING TOP,SEPIA OFFICINALIS JUICE, and VALERIAN TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; PASSIFLORA INCARNATA FLOWERING TOP; SEPIA OFFICINALIS JUICE; VALERIAN 2; 12; 3; 4; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20191231 62795-1025_1d260d90-55d6-4507-911a-040626fdbe5c 62795-1025 HUMAN OTC DRUG WellMind Alertness SEMECARPUS ANACARDIUM JUICE, ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, KEROSENE, and SELENIUM TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc. SEMECARPUS ANACARDIUM JUICE; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; KEROSENE; SELENIUM 6; 4; 3; 8; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1026_e919e88e-aed9-4031-a184-ace186160965 62795-1026 HUMAN OTC DRUG ReBoost Flu Symptom Relief ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GOLDENSEAL, LACHESIS MUTA VENOM, AND PHOSPHORUS TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GOLDENSEAL; LACHESIS MUTA VENOM; PHOSPHORUS 4; 3; 3; 6; 10; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1027_e25418ec-ef81-4277-89ed-b76462bf9e68 62795-1027 HUMAN OTC DRUG ReBoost Immune ACONITUM NAPELLUS,CYNANCHUM VINCETOXICUM ROOT, and SULFUR TABLET ORAL 20140930 UNAPPROVED HOMEOPATHIC MediNatura ACONITUM NAPELLUS; CYNANCHUM VINCETOXICUM ROOT; SULFUR 6; 5; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1028_b773c852-b00e-43a6-bdc6-4164f9e6d298 62795-1028 HUMAN OTC DRUG Clearlife ANTIMONY TRISULFIDE, ARNICA MONTANA ROOT, EUPHRASIA STRICTA,FORMIC ACID,GRAPHITE,HISTAMINE DIHYDROCHLORIDE,STRYCHNOS IGNATII SEED, ARCTIUM LAPPA ROOT, LEDUM PALUSTRE TWIG, LYCOPODIUM CLAVATUM SPORE, PINE TAR, SELENIUM, SULFUR, SULFURIC ACID, TELLURIUM, and THUJA OCCIDENTALIS LEAFY TWIG TABLET ORAL 20140930 UNAPPROVED HOMEOPATHIC MediNatura Inc. ANTIMONY TRISULFIDE; ARNICA MONTANA ROOT; EUPHRASIA STRICTA; FORMIC ACID; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; STRYCHNOS IGNATII SEED; ARCTIUM LAPPA ROOT; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PINE TAR; SELENIUM; SULFUR; SULFURIC ACID; TELLURIUM; THUJA OCCIDENTALIS LEAFY TWIG 10; 5; 6; 8; 10; 8; 6; 8; 7; 6; 10; 12; 12; 21; 10; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1029_03e598d8-8da4-2dd0-e054-00144ff88e88 62795-1029 HUMAN OTC DRUG T Relief T Relief TABLET ORAL 20140901 UNAPPROVED HOMEOPATHIC MediNatura Inc CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; BELLIS PERENNIS; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACHILLEA MILLEFOLIUM; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; ACONITUM NAPELLUS; ARNICA MONTANA 2; 3; 2; 2; 2; 2; 2; 2; 3; 4; 8; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1030_0552629a-5bea-5329-e054-00144ff88e88 62795-1030 HUMAN OTC DRUG T Relief Arthritis T Relief Arthritis TABLET ORAL 20141001 UNAPPROVED HOMEOPATHIC Medinatura ARNICA MONTANA ROOT; SUS SCROFA UMBILICAL CORD; BRYONIA ALBA ROOT; SOLANUM DULCAMARA TOP; SUS SCROFA EMBRYO; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; COMFREY ROOT; SUS SCROFA PLACENTA; SUS SCROFA CARTILAGE 3; 6; 3; 2; 6; 6; 8; 4; 3; 6; 7; 6; 4 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1031_73c6356e-3158-4439-b34e-094481723ab7 62795-1031 HUMAN OTC DRUG T-relief Spasm Pain HCP ACONITUM NAPELLUS,AMANITA MUSCARIA FRUITING BODY, AMMONIUM BROMIDE, ATROPINE SULFATE, ATROPA BELLADONNA, MATRICARIA RECUTITA, CITRULLUS COLOCYNTHIS FRUIT PULP,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, PASSIFLORA INCARNATA FLOWERING TOP, and VERATRUM ALBUM ROOT TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc ACONITUM NAPELLUS; AMANITA MUSCARIA FRUITING BODY; AMMONIUM BROMIDE; ATROPINE SULFATE; ATROPA BELLADONNA; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC SULFATE; GELSEMIUM SEMPERVIRENS ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PASSIFLORA INCARNATA FLOWERING TOP; VERATRUM ALBUM ROOT 6; 4; 4; 6; 6; 2; 3; 6; 6; 6; 2; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1032_984e1bfa-732a-4fd6-af74-11daf34b0b12 62795-1032 HUMAN OTC DRUG BodyAnew Fatigue HCP APIS MELLIFERA, TRIBASIC CALCIUM PHOSPHATE, SOLANUM DULCAMARA TOP, EQUISETUM HYEMALE, FERROUS IODIDE, FUMARIA OFFICINALIS FLOWERING TOP, GENTIANA LUTEA ROOT, GERANIUM ROBERTIANUM, NASTURTIUM OFFICINALE, SODIUM SULFATE,PINUS SYLVESTRIS LEAFY TWIG, SMILAX REGELII ROOT, SCROPHULARIA NODOSA, LOBARIA PULMONARIA, TEUCRIUM SCORODONIA FLOWERING TOP, and TEUCRIUM SCORODONIA FLOWERING TOP TABLET ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc APIS MELLIFERA; TRIBASIC CALCIUM PHOSPHATE; SOLANUM DULCAMARA TOP; EQUISETUM HYEMALE; FERROUS IODIDE; FUMARIA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; GERANIUM ROBERTIANUM; POTASSIUM IODIDE; NASTURTIUM OFFICINALE; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; SMILAX REGELII ROOT; SCROPHULARIA NODOSA; LOBARIA PULMONARIA; TEUCRIUM SCORODONIA FLOWERING TOP 6; 12; 6; 4; 12; 4; 5; 4; 8; 4; 3; 4; 6; 3; 5; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1033_598cc779-06cd-b27a-e053-2a91aa0a0909 62795-1033 HUMAN OTC DRUG T Relief Arthritis ARNICA MONTANA, BRYONIA ALBA ROOT, SUS SCROFA CARTILAGE, SOLANUM DULCAMARA TOP, SUS SCROFA EMBRYO,SUS SCROFA UMBILICAL CORD, LEDUM PALUSTRE TWIG,SUS SCROFA UMBILICAL CORD, LEDUM PALUSTRE TWIG,SUS SCROFA PLACENTA, RHODODENDRON AUREUM LEAF,TOXICODENDRON PUBESCENS LEAF, SANGUINARIA CANADENSIS ROOT, SULFUR, and COMFREY ROOT TABLET ORAL 20160301 UNAPPROVED HOMEOPATHIC MediNatura Inc ARNICA MONTANA; BRYONIA ALBA ROOT; SUS SCROFA CARTILAGE; SOLANUM DULCAMARA TOP; SUS SCROFA EMBRYO; SUS SCROFA UMBILICAL CORD; LEDUM PALUSTRE TWIG; SUS SCROFA PLACENTA; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; COMFREY ROOT 3; 3; 4; 2; 6; 6; 6; 6; 8; 4; 3; 6; 7 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1034_69916eca-6eef-4d98-ba85-6cbfb44e2840 62795-1034 HUMAN OTC DRUG T-Relief T-Relief TABLET, CHEWABLE ORAL 20151201 UNAPPROVED HOMEOPATHIC MediNatura Inc ACONITUM NAPELLUS; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; ARNICA MONTANA 3; 2; 2; 3; 4; 8; 2; 3; 2; 2; 2; 3 [hp_M]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1036_3398af9c-c5b1-086b-e054-00144ff8d46c 62795-1036 HUMAN OTC DRUG ReBoost Lemon Flu Symptom Relief ReBoost Flu Symptom Relief TABLET, CHEWABLE ORAL 20160524 UNAPPROVED HOMEOPATHIC MediNatura Inc ACONITUM NAPELLUS; GOLDENSEAL; EUPATORIUM PERFOLIATUM FLOWERING TOP; LACHESIS MUTA VENOM; PHOSPHORUS; ANHYDROUS CITRIC ACID; BRYONIA ALBA ROOT 4; 6; 3; 10; 8; 8; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1037_3b9fa542-0ffc-467d-a6f9-05ce1e418003 62795-1037 HUMAN OTC DRUG ReBoost Flu Symptom Relief Berry ACONITUM NAPELLUS, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GOLDENSEAL, LACHESIS MUTA VENOM, AND PHOSPHORUS TABLET, CHEWABLE ORAL 20160502 UNAPPROVED HOMEOPATHIC MediNatura ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GOLDENSEAL; LACHESIS MUTA VENOM; PHOSPHORUS 4; 3; 3; 6; 10; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20191231 62795-1111_62536193-3a2b-427e-a6f2-9b09653e6eee 62795-1111 HUMAN OTC DRUG Dr. Hendel Appetite Control OYSTER SHELL CALCIUM CARBONATE, CAPSICUM, IRON, FUCUS VESICULOSUS, GRAPHITE, STRYCHNOS IGNATII SEED, and LYCOPODIUM CLAVATUM SPORE TABLET ORAL 20160801 UNAPPROVED HOMEOPATHIC MediNatura Inc OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; IRON; FUCUS VESICULOSUS; GRAPHITE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1112_1fd3e612-34bb-4a7f-8a7f-ad7e687fc0f1 62795-1112 HUMAN OTC DRUG Arnica Montana 3X, 6X, 12X, 30X, 200X ARNICA MONTANA ROOT TABLET ORAL 20160801 UNAPPROVED HOMEOPATHIC MediNatura Inc ARNICA MONTANA ROOT 3 [hp_X]/1 N 20181231 62795-1113_8dae1032-6d7e-44d4-88b4-37200008a37c 62795-1113 HUMAN OTC DRUG Dr. Hendel Arthritis Pain Relief BRYONIA ALBA ROOT, ARNICA MONTANA, COLCHICUM AUTUMNALE BULB, SOLANUM DULCAMARA TOP, HARPAGOPHYTUM PROCUMBENS ROOT, LEDUM PALUSTRE TWIG, RHODODENDRON AUREUM LEAF,COMFREY ROOT, TOXICODENDRON PUBESCENS LEAF, OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, and SILICON DIOXIDE TABLET ORAL 20160801 UNAPPROVED HOMEOPATHIC MediNatura Inc BRYONIA ALBA ROOT; ARNICA MONTANA; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; HARPAGOPHYTUM PROCUMBENS ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; COMFREY ROOT; TOXICODENDRON PUBESCENS LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; SILICON DIOXIDE 4; 6; 6; 6; 6; 6; 6; 6; 8; 12; 12; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1114_533c9c76-4bbd-455d-b819-f3fdbe65a8de 62795-1114 HUMAN OTC DRUG Dr. Hendel Back Pain Relief HORSE CHESTNUT, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, SOLANUM DULCAMARA TOP, PSEUDOGNAPHALIUM OBTUSIFOLIUM, HYPERICUM PERFORATUM, STRYCHNOS NUX-VOMICA SEED, and TOXICODENDRON PUBESCENS LEAF TABLET ORAL 20160801 UNAPPROVED HOMEOPATHIC MediNatura Inc HORSE CHESTNUT; BRYONIA ALBA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; SOLANUM DULCAMARA TOP; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6; 6; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62795-1115_05c36528-5015-499f-86a9-89c23e2494f5 62795-1115 HUMAN OTC DRUG Calm Plus AVENA SATIVA FLOWERING TOP, MATRICARIA RECUTITA, PASSIFLORA INCARNATA FLOWERING, TRIBASIC CALCIUM PHOSPHATE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC, SODIUM CHLORIDE, SODIUM SULFATE, ZINC VALERATE DIHYDRATE, ARABICA COFFEE BEAN, STRYCHNOS NUX-VOMICA SEED, and SULFUR TABLET ORAL 20160901 UNAPPROVED HOMEOPATHIC MediNatura Inc AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM SULFATE; ZINC VALERATE DIHYDRATE; ARABICA COFFEE BEAN; STRYCHNOS NUX-VOMICA SEED; SULFUR 2; 2; 2; 2; 6; 6; 6; 6; 6; 6; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-1121_3f9cba79-e6cb-118f-e054-00144ff8d46c 62795-1121 HUMAN OTC DRUG WellMind Alertness Focus WellMind TABLET ORAL 20161101 UNAPPROVED HOMEOPATHIC MediNatura Inc. SEMECARPUS ANACARDIUM JUICE; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; KEROSENE; SELENIUM 6; 4; 3; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 62795-2000_11eaaa3b-640b-4a59-a5d1-0da38bc68b87 62795-2000 HUMAN OTC DRUG BodyAnew Multipack BodyAnew KIT 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc E 20171231 62795-2005_3cff9b36-75d4-4e81-be4b-cfa2f33eeab3 62795-2005 HUMAN OTC DRUG T-Relief ACONITUM NAPELLUS,ARNICA MONTANA ROOT, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP, and COMFREY ROOT LIQUID ORAL 20140930 UNAPPROVED HOMEOPATHIC MediNatura ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 3; 3; 2; 3; 2; 2; 2; 2; 3; 2; 4; 8 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL E 20171231 62795-2006_849a265a-1370-445e-b0db-65d283c8afaa 62795-2006 HUMAN OTC DRUG T-Relief ACONITUM NAPELLUS, ARNICA MONTANA, BAPTISIA TINCTORIA SOLUTION/ DROPS ORAL 20151201 UNAPPROVED HOMEOPATHIC MediNatura Inc CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; ACONITUM NAPELLUS; ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS 2; 2; 2; 3; 2; 4; 8; 3; 2; 2; 3; 3; 2 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 62795-2300_c05218a5-07ce-46d4-bbc5-c2c2b63ce153 62795-2300 HUMAN OTC DRUG Traumex ARNICA MONTANA ROOT TABLET ORAL 20170930 UNAPPROVED HOMEOPATHIC MediNatura Inc ARNICA MONTANA ROOT 3 [hp_X]/1 N 20181231 62795-2301_86f846f8-08cc-4991-b713-92726943d8b4 62795-2301 HUMAN OTC DRUG Traumed Arnica Root TABLET ORAL 20140930 UNAPPROVED HOMEOPATHIC MediNatura Inc. ARNICA MONTANA ROOT 6 [hp_X]/1 N 20181231 62795-3000_0c7faded-0daa-4b84-aa1a-5741a67a9981 62795-3000 HUMAN OTC DRUG Reboost Cough ANTIMONY POTASSIUM TARTRATE, PULSATILLA VULGARIS, DROSERA ROTUNDIFOLIA, HYOSCYAMUS NIGER, IPECAC, PULSATILLA VULGARIS, RUMEX CRISPUS ROOT, SPONGIA OFFICINALIS SKELETON, ROASTED, and LOBARIA PULMONARIA SYRUP ORAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura ANTIMONY POTASSIUM TARTRATE; DROSERA ROTUNDIFOLIA; HYOSCYAMUS NIGER; IPECAC; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; LOBARIA PULMONARIA 6; 3; 6; 4; 9; 4; 7; 6 [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL N 20181231 62795-4000_e5178651-64d2-40e7-b6c1-8241e27c268c 62795-4000 HUMAN OTC DRUG ReBoost APIS MELLIFERA, ASCLEPIAS TUBEROSA ROOT, ATROPA BELLADONNA, SPRAY ORAL 20140930 UNAPPROVED HOMEOPATHIC MediNatura APIS MELLIFERA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; SAGE 6; 5; 4; 4; 3; 3; 3; 3 [hp_X]/201mL; [hp_X]/201mL; [hp_X]/201mL; [hp_X]/201mL; [hp_X]/201mL; [hp_X]/201mL; [hp_X]/201mL; [hp_X]/201mL N 20181231 62795-4001_6c853e6d-2ce3-46f5-93d8-f13c02536882 62795-4001 HUMAN OTC DRUG ReBoost SILVER NITRATE,EUPHORBIA RESINIFERA RESIN, CALCIUM SULFIDE, GOLDENSEAL, POTASSIUM DICHROMATE,LUFFA OPERCULATA FRUIT, SODIUM CARBONATE, and PULSATILLA VULGARIS SPRAY NASAL 20140930 UNAPPROVED HOMEOPATHIC MediNatura SILVER NITRATE; EUPHORBIA RESINIFERA RESIN; CALCIUM SULFIDE; GOLDENSEAL; POTASSIUM DICHROMATE; LUFFA OPERCULATA FRUIT; SODIUM CARBONATE; PULSATILLA VULGARIS 10; 4; 10; 3; 6; 2; 6; 2 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62795-4002_96b8c154-df45-4a97-b31b-8dadf1b04a10 62795-4002 HUMAN OTC DRUG Clearlife ONION, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT and SULFUR SPRAY NASAL 20130411 UNAPPROVED HOMEOPATHIC MediNatura ONION; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SULFUR 4; 3; 12; 3; 11 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62795-4003_7b54d452-eb4b-4e2a-a9aa-43ba6cc6d2c2 62795-4003 HUMAN OTC DRUG ReBoost APIS MELLIFERA, ASCLEPIAS TUBEROSA ROOT, ATROPA BELLADONNA, SPRAY ORAL 20160510 UNAPPROVED HOMEOPATHIC MediNatura APIS MELLIFERA; ASCLEPIAS TUBEROSA ROOT; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; SAGE 6; 3; 5; 4; 4; 3; 3; 3; 3 [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL; [hp_X]/20mL N 20181231 62795-6000_c4004390-1697-4026-a7ad-9156b26728bf 62795-6000 HUMAN OTC DRUG T-Relief Arthritis ARNICA MONTANA ROOT, BRYONIA ALBA WHOLE, SUS SCROFA UMBILICAL CORD, SOLANUM DULCAMARA TOP, SUS SCROFA EMBRYO, SUS SCROFA UMBILICAL CORD, LEDUM PALUSTRE TWIG, SUS SCROFA PLACENTA, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAF, SANGUINARIA CANADENSIS ROOT, SULFUR, and COMFREY ROOT OINTMENT TOPICAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc ARNICA MONTANA ROOT; BRYONIA ALBA WHOLE; SUS SCROFA UMBILICAL CORD; SOLANUM DULCAMARA TOP; SUS SCROFA EMBRYO; SUS SCROFA CARTILAGE; LEDUM PALUSTRE TWIG; SUS SCROFA PLACENTA; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; COMFREY ROOT 3; 3; 4; 2; 6; 4; 6; 4; 8; 4; 3; 6; 7 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g E 20171231 62795-6001_6ac2d481-2f29-4bb8-b4ad-090638c4bccd 62795-6001 HUMAN OTC DRUG T-Relief Value Pack T-Relief KIT 20140830 UNAPPROVED HOMEOPATHIC MediNatura E 20171231 62795-6006_fd4d0d45-75bc-480f-a3c0-0a3c072be7d6 62795-6006 HUMAN OTC DRUG T-Relief Arthritis ARNICA MONTANA ROOT, BRYONIA ALBA WHOLE, SUS SCROFA UMBILICAL CORD, SOLANUM DULCAMARA TOP, SUS SCROFA EMBRYO, SUS SCROFA UMBILICAL CORD, LEDUM PALUSTRE TWIG, SUS SCROFA PLACENTA, RHODODENDRON AUREUM LEAF, TOXICODENDRON PUBESCENS LEAF, SANGUINARIA CANADENSIS ROOT, SULFUR, and COMFREY ROOT CREAM TOPICAL 20170131 UNAPPROVED HOMEOPATHIC MediNatura Inc ARNICA MONTANA ROOT; BRYONIA ALBA WHOLE; SUS SCROFA UMBILICAL CORD; SOLANUM DULCAMARA TOP; SUS SCROFA EMBRYO; SUS SCROFA CARTILAGE; LEDUM PALUSTRE TWIG; SUS SCROFA PLACENTA; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; COMFREY ROOT 2; 2; 4; 2; 4; 4; 6; 4; 8; 4; 3; 6; 7 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 62795-7000_6165b633-3e04-4fef-abb1-95f2c1a9a280 62795-7000 HUMAN OTC DRUG T-Relief ACONITUM NAPELLUS, ARNICA MONTANA ROOT, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA,BELLIS PERENNIS,CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA,ECHINACEA, UNSPECIFIED,HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM,RUTA GRAVEOLENS FLOWERING TOP, and COMFREY ROOT GEL TOPICAL 20140830 UNAPPROVED HOMEOPATHIC MediNatura Inc ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 1; 1; 4; 2; 2; 1; 2; 1; 2; 6; 2; 2; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g E 20171231 62795-7001_5af43ad7-1427-4805-a57f-5e91be4acc93 62795-7001 HUMAN OTC DRUG T-Relief ACONITUM NAPELLUS, ARNICA MONTANA ROOT, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA,BELLIS PERENNIS,CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA,ECHINACEA, UNSPECIFIED,HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM,RUTA GRAVEOLENS FLOWERING TOP, and COMFREY ROOT GEL TOPICAL 20150630 UNAPPROVED HOMEOPATHIC MediNatura Inc ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 1; 1; 4; 2; 2; 1; 2; 1; 2; 6; 2; 2; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g E 20171231 62795-7002_1aeea378-d4a4-453f-b9f3-70c83a37aba5 62795-7002 HUMAN OTC DRUG T-Relief ACONITUM NAPELLUS, ARNICA MONTANA ROOT,BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA,BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP,MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK,HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP, and COMFREY ROOT OINTMENT TOPICAL 20140901 UNAPPROVED HOMEOPATHIC MediNatura Inc ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 1; 1; 4; 2; 2; 1; 2; 2; 6; 2; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; 1/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g E 20171231 62795-7003_457652aa-925c-4217-9ab7-b729109e156c 62795-7003 HUMAN OTC DRUG T-Relief ACONITUM NAPELLUS, ARNICA MONTANA ROOT, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA, BELLIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA, ECHINACEA, UNSPECIFIED, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, RUTA GRAVEOLENS FLOWERING TOP, and COMFREY ROOT OINTMENT TOPICAL 20150731 UNAPPROVED HOMEOPATHIC MediNatura Inc ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 1; 1; 4; 2; 2; 1; 2; 1; 2; 6; 2; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g E 20171231 62795-7004_c63d605c-412b-4987-b9e1-43593629b222 62795-7004 HUMAN OTC DRUG T-Relief ACHILLEA MILLEFOLIUM, HYPERICUM PERFORATUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA, UNSPECIFIED, MATRICARIA RECUTITA, ATROPA BELLADONNA,COMFREY ROOT, ACONITUM NAPELLUS, BELLIS PERENNIS,ARNICA MONTANA, and RUTA GRAVEOLENS FLOWERING TOP OINTMENT TOPICAL 20151201 UNAPPROVED HOMEOPATHIC MediNatura Inc ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; ACONITUM NAPELLUS; COMFREY ROOT; ACHILLEA MILLEFOLIUM 1; 4; 2; 2; 1; 2; 1; 2; 6; 4; 1; 4; 2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20191231 62795-7005_b95ed505-4d3a-4f26-9c7b-2983a7e1b3f1 62795-7005 HUMAN OTC DRUG T-Relief ACONITUM NAPELLUS, ARNICA MONTANA, BAPTISIA TINCTORIA ROOT, ATROPA BELLADONNA,BELLIS PERENNIS,CALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA,ECHINACEA, UNSPECIFIED,HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM,RUTA GRAVEOLENS FLOWERING TOP, and COMFREY ROOT GEL TOPICAL 20160731 UNAPPROVED HOMEOPATHIC MediNatura Inc ACONITUM NAPELLUS; ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 1; 1; 4; 2; 2; 1; 2; 1; 2; 6; 2; 2; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20191231 62802-010_8a774791-8a8c-4d5c-8077-b31eb04bb33a 62802-010 HUMAN OTC DRUG OP Dark Tanning Xtreme Oil Amplifier SPF4 octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 3; 2 mL/100mL; mL/100mL E 20171231 62802-035_608fbdf5-9537-4103-a93f-6eddc678a227 62802-035 HUMAN OTC DRUG OP Dark Tanning Gel 4 octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 3; 2 mL/100mL; mL/100mL E 20171231 62802-038_2a9663ac-477e-4516-bda6-9016ced432ab 62802-038 HUMAN OTC DRUG OP Protective Spray Gel 8 octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc OCTINOXATE; OCTISALATE 4.5; 5 mL/100mL; mL/100mL E 20171231 62802-039_1187aaeb-0487-4a72-97c8-aef4b86d356d 62802-039 HUMAN OTC DRUG OP Protective Gel 15 octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 7.5; 5 g/100g; g/100g E 20171231 62802-085_d60a9658-b052-46af-8a13-f864b9fa36e5 62802-085 HUMAN OTC DRUG Ocean Potion Moisturizing Lip Potion 45 avobenzone, octisalate, octocrylene, oxybenzone, octinoxate LIPSTICK TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 7.5; 5; 5; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62802-102_c476ddb7-2eb0-42ba-8b1b-312228340442 62802-102 HUMAN OTC DRUG Parrot Head Floridays 30 avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 12; 5; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-103_9abf0f1f-792b-4f5d-abe2-9d95839b1d0b 62802-103 HUMAN OTC DRUG Parrot Head Floridays 50 avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-104_d2219616-7e13-4afc-a979-735b933dfd80 62802-104 HUMAN OTC DRUG Parrot Head Floridays Face 50 avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-106_8c9d655f-075b-4b5b-9948-42f594abe375 62802-106 HUMAN OTC DRUG Parrot Head Fins Up Sport 15 Mist Sunscreen avobenzone, homosalate,octisalate SPRAY TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; AVOBENZONE 7.5; 5; 1.2 mL/100mL; mL/100mL; mL/100mL E 20171231 62802-107_d0e4cd05-b81a-4254-ae24-48b170dc85fc 62802-107 HUMAN OTC DRUG Parrot Head Fins Up Sport 30 Mist avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 13; 5; 6; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-108_61d77960-daa2-494e-b0ce-fc50dbc98184 62802-108 HUMAN OTC DRUG Parrot Head Fins Up 50 Mist Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-109_10ff23e6-29f9-47db-a646-5480b9e227e5 62802-109 HUMAN OTC DRUG Parrot Head Fins Up Sport 15 avobenzone, homosalate,octisalate LOTION TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; AVOBENZONE 7.5; 5; 1.2 mL/100mL; mL/100mL; mL/100mL E 20171231 62802-110_ef0ebaf0-1a9d-4993-99f9-d5b35852144b 62802-110 HUMAN OTC DRUG Parrot Head Fins Up Sport 30 avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 12; 5; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-111_555665d0-16c7-4640-8c53-e08826138cbe 62802-111 HUMAN OTC DRUG Parrot Head Parakeet Kids 50 Mist Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-112_0573b990-25eb-4a84-9976-6be493040acc 62802-112 HUMAN OTC DRUG Parrot Head Parakeet Kids 50 avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120510 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-114_fb111532-83e3-49f1-99d0-327971b58890 62802-114 HUMAN OTC DRUG Parrot Head Dedicated to Sunshine Oil 4 octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 4.5; 5 mL/100mL; mL/100mL E 20171231 62802-115_7a5dc6e3-3962-436b-9a60-2c8b5a881df9 62802-115 HUMAN OTC DRUG Parrot Head Dedicated to Sunshine Tan Enhancer 8 octinoxate, octisalate SPRAY TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 4.5; 5 mL/100mL; mL/100mL E 20171231 62802-116_60b4c6af-f07a-447d-a5d4-d498ed5769e7 62802-116 HUMAN OTC DRUG Parrot Head Dedicated to Sunshine Tan Enhancer 15 octinoxate, octisalate SPRAY TOPICAL 20120511 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 7.5; 5 mL/100mL; mL/100mL E 20171231 62802-140_d0795779-170b-4874-a15b-d445278909c2 62802-140 HUMAN OTC DRUG Ocean Potion Quick Dry 15 Sunscreen avobenzone, homosalate,octisalate LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; AVOBENZONE 7.5; 5; 1.2 mL/100mL; mL/100mL; mL/100mL E 20171231 62802-144_c5667f67-27ac-44eb-bae0-61897db62c7e 62802-144 HUMAN OTC DRUG Ocean Potion Quick Dry SPF 70 Sunscreen avobenzone, homosalate, oxybenzone,octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 15; 5; 6; 2; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-145_30a8923d-fea4-499a-bdae-1f8e21cca3f2 62802-145 HUMAN OTC DRUG Ocean Potion Quick Dry 30 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 12; 5; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-146_589aa513-327e-4d15-9785-130a59f92e22 62802-146 HUMAN OTC DRUG Ocean Potion Cool Dry Touch Sport 30 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 12; 5; 5; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-147_763a1bf9-6c30-465c-8de8-3ae084a62182 62802-147 HUMAN OTC DRUG Ocean Potion Quick Dry 50 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-148_a0c3225e-d4a4-49ac-ba7f-69e27d97eef3 62802-148 HUMAN OTC DRUG Ocean Potion Cool Dry Touch Sport 30 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-150_1b1d58af-e181-4628-8f78-fb117dd6e7dc 62802-150 HUMAN OTC DRUG Ocean Potion Water Sport SPF50 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-172_1134f978-a279-46e7-9bef-9fd648fa89a9 62802-172 HUMAN OTC DRUG Ocean Potion Instant Burn Relief Ice lidocaine GEL TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part348 Sun & Skin Care Research, LLC LIDOCAINE .5 g/100g E 20171231 62802-182_238d0509-9233-4b5b-9a94-d6b6a3221e6f 62802-182 HUMAN OTC DRUG Ocean Potion Gentle and Sensitive 50 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 g/100g; g/100g; g/100g; g/100g E 20171231 62802-183_7d252d05-7a0e-41a0-a054-d07f972cfe58 62802-183 HUMAN OTC DRUG Ocean Potion Quick Dry Kids 50 Sunscreen avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, Inc HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-206_de85d956-6527-4d25-af8f-557a99c78dc0 62802-206 HUMAN OTC DRUG NO-AD SPF4 Dark Tanning Oil octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 3; 2 mL/100mL; mL/100mL E 20171231 62802-208_8e75786a-93c4-468f-967d-61fd7d829e87 62802-208 HUMAN OTC DRUG NO-AD Dark Tanning SPF 4 octinoxate, octisalate LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 3; 2 g/100g; g/100g E 20171231 62802-210_fe0ea217-9465-44c2-ba92-80db70ac4732 62802-210 HUMAN OTC DRUG NO-AD SPF 8 Tanning octinoxate, octisalate LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 4.5; 5 g/100g; g/100g E 20171231 62802-212_d3949a7a-dcc2-40e3-814b-a3e3d0fda40a 62802-212 HUMAN OTC DRUG NO-AD 15 Sunscreen avobenzone, homosalate,octisalate LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; AVOBENZONE 7.5; 5; 1.2 mL/100mL; mL/100mL; mL/100mL E 20171231 62802-213_53429f50-a195-4769-b3aa-7d493aaa8ac4 62802-213 HUMAN OTC DRUG NO-AD Splash 30 Sunscreen avobenzone, homosalate, octisalate, oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE 10; 5; 3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-214_398ae829-1f70-4e66-aa18-dd2eeff06b32 62802-214 HUMAN OTC DRUG NO-AD 30 Sunscreen avobenzone, homosalate, octisalate, oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC AVOBENZONE; OCTISALATE; OXYBENZONE; HOMOSALATE 2; 5; 5; 10 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-218_a06e565a-08f2-498f-b926-609b2faf1355 62802-218 HUMAN OTC DRUG NO-AD 45 Sunscreen avobenzone, homosalate, octisalate, oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE 15; 5; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-220_11e4c5f7-48b6-4e9e-bd95-b761c45b5965 62802-220 HUMAN OTC DRUG NO-AD Sport 50 Sunscreen avobenzone, homosalate, octisalate, oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE 15; 5; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-222_0debc631-c942-4669-9db1-986d55b83ca6 62802-222 HUMAN OTC DRUG NO-AD Kids 50 Sunscreen avobenzone, homosalate, octisalate, oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE 15; 5; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-224_46f39437-deb5-45dd-8d22-17395b97619b 62802-224 HUMAN OTC DRUG NO-AD 60 Sunscreen avobenzone, homosalate, octisalate, oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE 15; 5; 6; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-228_499ba605-1d25-49c0-961c-c2503a15982a 62802-228 HUMAN OTC DRUG NO-AD 85 Sunscreen avobenzone, homosalate, octisalate, oxybenzone, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 15; 5; 6; 5; 3 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62802-291_00731a42-a9fe-48d6-a225-735590554130 62802-291 HUMAN OTC DRUG NO-AD Kids SPF50 Continuous Mist Sunscreen avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 10; 5; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62802-295_a47b6525-a4f2-4560-81c7-29b5a0835af7 62802-295 HUMAN OTC DRUG NO-AD Sport SPF30 Continuous Mist Sunscreen avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE 10; 5; 3; 2 g/100g; g/100g; g/100g; g/100g E 20171231 62802-301_d422013d-3ed1-4256-a379-c6b5e9504d17 62802-301 HUMAN OTC DRUG Ocean Potion Intell Mist 50 Kids Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 g/100g; g/100g; g/100g; g/100g E 20171231 62802-362_d7f5c8a0-1dcb-4fda-a29f-40734e41cdfc 62802-362 HUMAN OTC DRUG Bull Frog Kids Sunscreen 35 avobenzone, homosalate, octisalate, oxybenzone, octocrylene LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 12; 5; 3; 5 g/100g; g/100g; g/100g; g/100g E 20171231 62802-390_ba962eaf-27af-49e0-a8da-1a9192404943 62802-390 HUMAN OTC DRUG Bull Frog Kids Mist 50 avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 10; 5; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62802-406_1e1ef577-e0fa-4c30-8d52-173d708944d4 62802-406 HUMAN OTC DRUG Bull Frog Marathon Mist 36 avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 11; 5; 5; 2; 3 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62802-495_87436d6c-0e15-480e-b8dc-1f3618c25b6b 62802-495 HUMAN OTC DRUG Bull Frog Marathon Mist 50 avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 10; 5; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62802-501_6a724d70-e931-48aa-9e0b-bd096460be06 62802-501 HUMAN OTC DRUG NO-AD SPF45 Continuous Mist Sunscreen avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20120103 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 10; 5; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62802-580_e50ed283-ec3e-4a7a-ac59-b7139e549cdb 62802-580 HUMAN OTC DRUG Ocean Potion Instant Dry 50 Dab-On Spotstick avobenzone, homosalate, octisalate, octocrylene LIQUID TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-581_5009f27d-a468-4aa3-94ac-4e57b7107c03 62802-581 HUMAN OTC DRUG Ocean Potion 50 Instant Dry Kid Spotstick avobenzone, homosalate, octisalate, octocrylene LIQUID TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-600_b9914b80-2352-42d3-899d-959ae2f5ef1e 62802-600 HUMAN OTC DRUG OP Dark Formula Xtreme Tanning 4 octinoxate, octisalate LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 3; 2 mL/100mL; mL/100mL E 20171231 62802-644_29b3b675-0296-4222-b43a-2f16752715c0 62802-644 HUMAN OTC DRUG Ocean Potion Instant Dry 70 Mist Sunscreen avobenzone, homosalate, octisalate, octocrylene, oxybenzone SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; OXYBENZONE 15; 5; 2; 2; 6 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62802-646_3c280c0d-5fe2-4dbe-904d-58bc26ce1507 62802-646 HUMAN OTC DRUG Ocean Potion Instant Dry 30 Mist Sport Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 13; 5; 6; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-647_dd61e764-eacb-4962-a972-bfe2f2f5cf69 62802-647 HUMAN OTC DRUG Ocean Potion Instant Dry 50 Mist Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-649_7420bb51-5dfe-40e9-936b-4943dc537bc5 62802-649 HUMAN OTC DRUG Bull Frog Water Armor Super 40 meradimate, octinoxate, octisalate, octocrylene, oxybenzone, titanium dixoide LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC MERADIMATE; OCTISALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 5; 5; 7.5; 10; 6; 4.5 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62802-650_0491cf71-d9c9-4699-b6e9-cc20fa75761d 62802-650 HUMAN OTC DRUG Ocean Potion Instant Dry 30 Mist Water Sport Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 13; 5; 6; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-651_239e1cac-5808-4082-a6e0-e6f3c34c6974 62802-651 HUMAN OTC DRUG Ocean Potion Instant Dry 30 Mist Water Sport Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 13; 5; 6; 3 g/100g; g/100g; g/100g; g/100g E 20171231 62802-653_1935a632-06d9-4c9f-8e92-98a78f177b8e 62802-653 HUMAN OTC DRUG Bull Frog Water Armor Sport Quik 50 avobenzone, homosalate, octisalate, oxybenzone, octocrylene GEL TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 15; 5; 6; 10; 3 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62802-668_6c05d663-b2ed-4301-9661-9dc509c274d9 62802-668 HUMAN OTC DRUG Bull Frog Insta-Cool Mist 50 avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 10; 5; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62802-682_a10e6576-e0d5-41d7-9819-099909584618 62802-682 HUMAN OTC DRUG Ocean Potion Instant Dry 50 Mist Kids Sunscreen avobenzone, homosalate, octisalate, octocrylene SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 15; 5; 7; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 62802-683_dc39a032-d863-4961-bf5e-a13a100486b7 62802-683 HUMAN OTC DRUG Bull Frog Water Armor Sport 50 avobenzone, homosalate, octisalate, oxybenzone, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 10; 5; 5; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 62802-690_efaf6a17-47fc-4872-9607-cfca6067d104 62802-690 HUMAN OTC DRUG OP Protective Xtreme Tanning 8 octinoxate, octisalate LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 4.5; 5 mL/100mL; mL/100mL E 20171231 62802-773_eb7591c7-30fc-44fd-9855-65021ddc967c 62802-773 HUMAN OTC DRUG BULLFROG DEET FREE Mosquito Coast Sunscreen with Insect Repellent SPF 30 Octinoxate, homosalate, octisalate, octocrylene SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTISALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 5; 7.5; 10; 6 g/100g; g/100g; g/100g; g/100g E 20171231 62802-915_05b9a012-d1ab-41e1-b9ec-a26f3332c091 62802-915 HUMAN OTC DRUG OP Protective Mist 15 Oil Free octinoxate, octisalate SPRAY TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Sun & Skin Care Research, LLC OCTINOXATE; OCTISALATE 7; 5 mL/100mL; mL/100mL E 20171231 62806-0001_24fae211-5eeb-48b4-9aa6-75303289cdc0 62806-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19880101 UNAPPROVED MEDICAL GAS Wright & Filippis, Inc. OXYGEN 99 L/100L E 20171231 62818-100_3981a814-dfa8-4e1b-8f6f-33c45185aed6 62818-100 HUMAN OTC DRUG Vegetability Natural Pyrithione Zinc SHAMPOO TOPICAL 20140501 OTC MONOGRAPH FINAL part358H Biometics Co.,Ltd. PYRITHIONE ZINC 5 g/500g N 20181231 62818-101_041856fa-1f3e-4a4b-ba5a-f9326e9c620d 62818-101 HUMAN OTC DRUG Acne Solution salicylic acid SOLUTION TOPICAL 20140501 OTC MONOGRAPH FINAL part333D Biometics Co.,Ltd. SALICYLIC ACID .2 g/40g N 20181231 62818-102_61c0af32-1b3f-4d55-baf3-b709a9d3dc66 62818-102 HUMAN OTC DRUG AtoQ30 Solution Colloidal Oatmeal SOLUTION TOPICAL 20140501 20240501 OTC MONOGRAPH FINAL part347 Biometics Co.,Ltd. OATMEAL .8 g/40g E 20171231 62819-268_1c90ff10-f586-4b5e-85a5-8b030b37039c 62819-268 HUMAN OTC DRUG Total Solutions Hygien Hand Benzalkonium SOAP TOPICAL 20130118 OTC MONOGRAPH NOT FINAL part333E Athea Laboratories, Inc. BENZALKONIUM CHLORIDE .12 g/100mL N 20181231 62830-265_d945c7a2-b5d8-4886-973e-73e6e518a828 62830-265 HUMAN OTC DRUG One Step Antiseptic Hand Wash BENZALKONIUM CHLORIDE SOAP TOPICAL 20171227 OTC MONOGRAPH NOT FINAL part333E RECO Research Chemical Specialties Company, Inc. BENZALKONIUM CHLORIDE 25 mg/mL N 20181231 62832-080_a80b00fe-1ef5-4327-aaa4-de4463db3cb3 62832-080 HUMAN OTC DRUG GENUINE JOE Cleaning Supplies Antibacterial Foam So ap Refill Chloroxylenol LIQUID TOPICAL 20080930 OTC MONOGRAPH NOT FINAL part333E S.P. Richards Company CHLOROXYLENOL .003 mg/mL N 20181231 62832-118_a96fd5e0-8bc7-4bdb-92e2-0a164b4e1372 62832-118 HUMAN OTC DRUG Benzalkonium Chloride Benzalkonium Chloride LIQUID TOPICAL 20171103 OTC MONOGRAPH NOT FINAL part333A S.P. Richards Company BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 62832-437_21cb78dd-6ff0-4995-a72f-31c1c1c34f36 62832-437 HUMAN OTC DRUG Alcohol Alcohol LIQUID TOPICAL 20171103 OTC MONOGRAPH NOT FINAL part333A S.P. Richards Company ALCOHOL 63 mg/mL N 20181231 62832-447_995e7a1d-daee-4f96-8fdb-f285a7b0b826 62832-447 HUMAN OTC DRUG Ethyl alcohol Ethyl Alcohol LOTION TOPICAL 20171103 OTC MONOGRAPH NOT FINAL part333A S.P. Richards Company ALCOHOL .62 mL/mL N 20181231 62835-689_28466162-800f-4bc1-8321-09a2bc7c3863 62835-689 HUMAN OTC DRUG Growth Hormone Liver Extract, HGH Somatotropin, Pituitarum Extract LIQUID ORAL 20140501 UNAPPROVED HOMEOPATHIC Midlink LLC PORK LIVER; SOMATROPIN; SUS SCROFA PITUITARY GLAND 6; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 62839-0125_fbcc7ce6-3076-4f0b-9ce0-f2cc076114d7 62839-0125 HUMAN OTC DRUG Nu Skin 180 Degree UV Block Hydrator SPF 18 Octinoxate and Zinc Oxide LOTION TOPICAL 20010610 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; ZINC OXIDE 7.5; 5.2705 mL/100mL; mL/100mL N 20181231 62839-0138_454ae770-e9cb-4796-bc90-d00945e03ddb 62839-0138 HUMAN OTC DRUG Nu Skin Clear Action Acne Medication Toner Salicylic Acid LIQUID TOPICAL 20020125 OTC MONOGRAPH FINAL part333D NSE Products, Inc. SALICYLIC ACID .5 mL/100mL N 20181231 62839-0271_9f2f5ced-284b-494b-97e2-39c658eba2a8 62839-0271 HUMAN OTC DRUG Nu Skin Antibacterial Body Cleansing Triclosan GEL TOPICAL 19960826 OTC MONOGRAPH NOT FINAL part333E NSE Products, Inc. TRICLOSAN .55 mL/100mL N 20181231 62839-0272_1f2d622d-cb60-493b-bbfc-360e2c68f4f8 62839-0272 HUMAN OTC DRUG Moisture Restore Day Protective Mattefying Broad Spectrum SPF15 Combination to Oily Octinoxate, Octisalate, and Titanium Dioxide LOTION TOPICAL 20010610 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 30; 28 mg/mL; mg/mL; mg/mL N 20181231 62839-0273_34287e3f-f79d-4496-a549-64b59d755dba 62839-0273 HUMAN OTC DRUG Nu Skin Tri-Phasic White Day Milk Broad Spectrum SPF 15 Avobenzone, Octinoxate, and Octisalate LOTION TOPICAL 20130401 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 24; 74; 30 mg/mL; mg/mL; mg/mL N 20181231 62839-0289_346d1b9f-d977-43c4-8794-a317dbcb8c55 62839-0289 HUMAN OTC DRUG NU SKIN ageLOC Radiant Day SPF 22 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 4; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 62839-0369_efb19f26-a0fc-4f72-9243-caed20a327c9 62839-0369 HUMAN OTC DRUG Nu Skin Sunright Lip Balm Broad Spectrum SPF 15 Octinoxate and Octocrylene STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTOCRYLENE 75; 27.9 mg/mL; mg/mL N 20181231 62839-0388_cfac745b-03ed-4082-b13a-fbaa99ac6eb7 62839-0388 HUMAN OTC DRUG Nu Skin Clear Action Acne Medication Foaming Cleanser Salicylic Acid LOTION TOPICAL 20100901 OTC MONOGRAPH FINAL part333D NSE Products, Inc. SALICYLIC ACID 5 g/1000mL N 20181231 62839-0390_a0e5a958-f9a4-488b-bc19-eb591e299cfe 62839-0390 HUMAN OTC DRUG Nu Skin Clear Action Acne Medication Night Treatment Salicylic Acid GEL TOPICAL 20100901 OTC MONOGRAPH FINAL part333D NSE Products, Inc. SALICYLIC ACID 5 g/1000mL N 20181231 62839-0802_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0802 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Delicate Ivory Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL N 20181231 62839-0803_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0803 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Shell Rose Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL N 20181231 62839-0804_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0804 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Natural Beige Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL N 20181231 62839-0805_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0805 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Honey Beige Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL N 20181231 62839-0806_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0806 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Golden Beige Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL N 20181231 62839-0807_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0807 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Sunset Beige Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL N 20181231 62839-0808_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0808 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Sandalwood Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL N 20181231 62839-0811_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0811 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Saffron Whisper Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL N 20181231 62839-0812_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0812 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Amber Mist Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL N 20181231 62839-0820_3564b23a-d9e5-4b8c-af2b-946a2c1d962d 62839-0820 HUMAN OTC DRUG Nu Skin Nu Colour MoisturShade Finish SPF 15 Caramel Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 20; 30; 65.22 g/1000mL; g/1000mL; g/1000mL; g/1000mL N 20181231 62839-0853_da77156c-8085-461b-a468-995842ec862a 62839-0853 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Neutral Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0854_da77156c-8085-461b-a468-995842ec862a 62839-0854 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Soft Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0855_da77156c-8085-461b-a468-995842ec862a 62839-0855 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Delicate Ivory Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0856_da77156c-8085-461b-a468-995842ec862a 62839-0856 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Sunny Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0857_da77156c-8085-461b-a468-995842ec862a 62839-0857 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Almond Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0858_da77156c-8085-461b-a468-995842ec862a 62839-0858 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Sunset Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0859_da77156c-8085-461b-a468-995842ec862a 62839-0859 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Tawny Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0860_da77156c-8085-461b-a468-995842ec862a 62839-0860 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Mocha Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0861_da77156c-8085-461b-a468-995842ec862a 62839-0861 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Honey Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0862_da77156c-8085-461b-a468-995842ec862a 62839-0862 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0863_da77156c-8085-461b-a468-995842ec862a 62839-0863 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Ochre Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0864_da77156c-8085-461b-a468-995842ec862a 62839-0864 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Pink Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0865_da77156c-8085-461b-a468-995842ec862a 62839-0865 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Pink Ochre Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0866_da77156c-8085-461b-a468-995842ec862a 62839-0866 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Medium Ochre Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-0867_da77156c-8085-461b-a468-995842ec862a 62839-0867 HUMAN OTC DRUG Nu Skin Nu Colour advanced finish broad spectrum SPF 15 - Medium Beige Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE 75; 20; 40 mg/mL; mg/mL; mg/mL N 20181231 62839-1038_aa426afc-1024-4afa-9d4c-12a5a4ab559f 62839-1038 HUMAN OTC DRUG Nu Skin Clear Action Acne Medication Day Treatment Salicylic Acid GEL TOPICAL 20020125 OTC MONOGRAPH FINAL part333D NSE Products, Inc. SALICYLIC ACID 5 g/1000mL N 20181231 62839-1083_9c443c73-914a-4c47-b220-b022da8f18e1 62839-1083 HUMAN OTC DRUG Epoch Alcohol GEL TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part333E NSE Products, Inc. ALCOHOL 61.9937 mL/100mL N 20191231 62839-1084_7f2655d9-d393-4c71-b29a-c6f24dcaf5cd 62839-1084 HUMAN OTC DRUG Epoch Salicylic Acid GEL TOPICAL 20010610 OTC MONOGRAPH FINAL part333D NSE Products, Inc. SALICYLIC ACID 20 g/1000mL N 20181231 62839-1101_a5944d01-79d1-4ee8-8a81-4d239c8ec2ec 62839-1101 HUMAN OTC DRUG Nu Skin Nu Colour Tinted Moisturizer Broad Spectrum SPF 15 Fair Octinoxate and Octisalate LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 20 mg/mL; mg/mL N 20181231 62839-1102_a5944d01-79d1-4ee8-8a81-4d239c8ec2ec 62839-1102 HUMAN OTC DRUG Nu Skin Nu Colour Tinted Moisturizer Broad Spectrum SPF 15 Sand Octinoxate and Octisalate LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 20 mg/mL; mg/mL N 20181231 62839-1103_a5944d01-79d1-4ee8-8a81-4d239c8ec2ec 62839-1103 HUMAN OTC DRUG Nu Skin Nu Colour Tinted Moisturizer Broad Spectrum SPF 15 Honey Octinoxate and Octisalate LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 20 mg/mL; mg/mL N 20181231 62839-1104_a5944d01-79d1-4ee8-8a81-4d239c8ec2ec 62839-1104 HUMAN OTC DRUG Nu Skin Nu Colour Tinted Moisturizer Broad Spectrum SPF 15 Beige Octinoxate and Octisalate LOTION TOPICAL 20110103 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 20 mg/mL; mg/mL N 20181231 62839-1113_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1113 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Fair Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL N 20181231 62839-1114_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1114 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Sand Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL N 20181231 62839-1115_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1115 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Honey Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL N 20181231 62839-1116_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1116 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Beige Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL N 20181231 62839-1133_889448cd-8752-41eb-b71c-56650df08198 62839-1133 HUMAN OTC DRUG Sunright BodyBlock SPF15 Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 30; 30 g/1000mL; g/1000mL; g/1000mL; g/1000mL N 20181231 62839-1135_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1135 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Ochre Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL N 20181231 62839-1136_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1136 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Pink Ochre Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL N 20181231 62839-1137_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1137 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Medium Ochre Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL N 20181231 62839-1138_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1138 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Pink Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL N 20181231 62839-1139_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1139 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Natural Beige Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL N 20181231 62839-1140_1132b27d-551a-4d65-a76e-9748efa4a631 62839-1140 HUMAN OTC DRUG Nu Skin Nu Colour advanced tinted moisturizer broad spectrum SPF 15 - Medium Beige Octinoxate and Octisalate LOTION TOPICAL 20141027 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; OCTISALATE 50; 28 mg/mL; mg/mL N 20181231 62839-1151_0b506952-b76a-4687-b597-2ba48bed56ff 62839-1151 HUMAN OTC DRUG AP-24 Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20170508 OTC MONOGRAPH FINAL part355 NSE Products, Inc. SODIUM MONOFLUOROPHOSPHATE 8.6 mg/g N 20181231 62839-1152_84e1d4d6-745e-4bf1-b196-1bdf9f07a3ca 62839-1152 HUMAN OTC DRUG AP-24 Sodium Fluoride MOUTHWASH ORAL 20170508 OTC MONOGRAPH FINAL part355 NSE Products, Inc. SODIUM FLUORIDE .2 mg/mL N 20181231 62839-1155_e2651a88-0bd4-475b-bf7e-79d267c75ea0 62839-1155 HUMAN OTC DRUG AP-24 Whitening Sodium Monofluorophosphate PASTE DENTAL 20170508 OTC MONOGRAPH FINAL part355 NSE Products, Inc. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 62839-1254_3ea9a803-714f-4985-b279-e1aac88d45af 62839-1254 HUMAN OTC DRUG Nu Skin 180 Degree UV Defense Hydrator SPF 18 Octinoxate and Zinc Oxide LOTION TOPICAL 20130801 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; ZINC OXIDE 75; 54 mg/mL; mg/mL N 20181231 62839-1332_a473dba0-18a6-4749-88ba-63697e6ed174 62839-1332 HUMAN OTC DRUG Sunright Broad Spectrum SPF 30 Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 75; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62839-1344_55a4c68b-22fa-41c9-b457-0bb9322bae71 62839-1344 HUMAN OTC DRUG Nu Skin Sunright 35 Broad Spectrum SPF 35 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20140423 OTC MONOGRAPH FINAL part352 NSE Products, Inc. TITANIUM DIOXIDE; ZINC OXIDE 42; 45 mg/mL; mg/mL N 20181231 62839-1345_34289de8-2922-4dbb-adf5-a4bf88cd69eb 62839-1345 HUMAN OTC DRUG Nu Skin Sunright 50 Broad Spectrum SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate, and Octocrylene LOTION TOPICAL 20140602 OTC MONOGRAPH FINAL part352 NSE Products, Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 100; 75; 50; 65 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62839-1455_8dfb7c49-722e-49e7-af3c-a20733cbc5cd 62839-1455 HUMAN OTC DRUG Dividends Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20030107 OTC MONOGRAPH FINAL part350 NSE Products, Inc. ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 62839-1495_76fc4233-c235-4d62-acc6-3bfeade4e80e 62839-1495 HUMAN OTC DRUG ageLOC LumiSpa Treatment Cleanser Acne Salicylic Acid LOTION TOPICAL 20171001 OTC MONOGRAPH FINAL part333D NSE Products, Inc SALICYLIC ACID 5 mg/mL N 20181231 62839-1616_52d6e050-41ac-4d5b-8f5b-98e78c8c00e6 62839-1616 HUMAN OTC DRUG Nu Skin ageLOC Me Day T1 Broad Spectrum SPF 25 Homosalate, Octinoxate, Avobenzone, and Octocrylene LOTION TOPICAL 20160501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. HOMOSALATE; OCTINOXATE; AVOBENZONE; OCTOCRYLENE 40; 35; 30; 27.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62839-1617_0acecbf8-272f-4b97-886c-00699cfe3ec4 62839-1617 HUMAN OTC DRUG Nu Skin ageLOC Me Day S1 Broad Spectrum SPF 25 Homosalate, Octinoxate, Avobenzone, and Octocrylene LOTION TOPICAL 20160501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. HOMOSALATE; OCTINOXATE; AVOBENZONE; OCTOCRYLENE 40; 35; 30; 27.9 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62839-1618_0cae0c5e-fa62-4093-aece-f0bdcd8aadbd 62839-1618 HUMAN OTC DRUG Nu Skin ageLOC Me Day T2 Broad Spectrum SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20160501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. TITANIUM DIOXIDE; ZINC OXIDE 34; 33.9 mg/mL; mg/mL N 20181231 62839-1619_82f43ab8-6f8b-4931-a5ef-3e0733cff9c7 62839-1619 HUMAN OTC DRUG Nu Skin ageLOC Me Day S2 Broad Spectrum SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20160501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. TITANIUM DIOXIDE; ZINC OXIDE 34; 33.9 mg/mL; mg/mL N 20181231 62839-1629_031100d8-e6dd-4b4f-9e34-f884ab97a37b 62839-1629 HUMAN OTC DRUG Nu Skin ageLOC Me Day T3 Broad Spectrum SPF 25 Homosalate, Octisalate, Avobenzone, and Octocrylene LOTION TOPICAL 20160501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 80; 40; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62839-1630_35def0f1-9879-4745-b3f3-a11c5b723f87 62839-1630 HUMAN OTC DRUG Nu Skin ageLOC Me Day S3 Broad Spectrum SPF 25 Homosalate, Octisalate, Avobenzone, and Octocrylene LOTION TOPICAL 20160501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 80; 40; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62839-1637_cde2c892-34d3-4ea7-b0ee-8419e5bfc2ba 62839-1637 HUMAN OTC DRUG Nu Skin ageLOC Me Day T9 Broad Spectrum SPF 25 Octinoxate, Avobenzone, Octocrylene, and Homosalate LOTION TOPICAL 20160501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE 40; 23; 20; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62839-1638_d7c25d9a-a947-477f-aa6d-1044f3821d9b 62839-1638 HUMAN OTC DRUG Nu Skin ageLOC Me Day S9 Broad Spectrum SPF 25 Octinoxate, Avobenzone, Octocrylene, and Homosalate LOTION TOPICAL 20160501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE 40; 23; 20; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62839-1640_e449f26e-824f-4979-b7e6-d8a9c8372303 62839-1640 HUMAN OTC DRUG Nu Skin ageLOC Me Homosalate, Octinoxate, Avobenzone, and Octocrylene KIT 20160501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. N 20181231 62839-2728_2b387dff-ac60-43f4-a8e8-73f6891ce5c4 62839-2728 HUMAN OTC DRUG Nu Skin Moisture Restore Day Protective Lotion SPF 15 Normal to Dry Skin Octinoxate and Titanium Dioxide LOTION TOPICAL 20010610 OTC MONOGRAPH NOT FINAL part352 NSE Products, Inc. OCTINOXATE; TITANIUM DIOXIDE 75; 38 g/1000mL; g/1000mL N 20181231 62839-2734_71dbd24f-cd19-42f4-bd0f-4c9afc0513e3 62839-2734 HUMAN OTC DRUG Nu Skin Tri-Phasic White System Avobenzone, Octinoxate, and Octisalate KIT 20130401 OTC MONOGRAPH FINAL part352 NSE Products, Inc. N 20181231 62839-2810_5621ab47-a70b-4439-bef1-e644d4a3ce31 62839-2810 HUMAN OTC DRUG Epoch Ava Puhi Moni Pyrithione Zinc SHAMPOO TOPICAL 20091001 OTC MONOGRAPH FINAL part358H NSE Products, Inc. PYRITHIONE ZINC 10 mL/1000mL N 20181231 62839-3887_dcbdfbbb-ba33-42c1-a9eb-a86de58c5d7c 62839-3887 HUMAN OTC DRUG ageLOC Elements Avobenzone, Homosalate, Octisalate, and Octocrylene KIT 20130501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. N 20181231 62839-3888_521a7d0e-788e-4da5-bf03-6a2efebf9989 62839-3888 HUMAN OTC DRUG ageLOC Transformation Avobenzone, Homosalate, Octisalate, and Octocrylene KIT 20130501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. N 20181231 62839-3904_a6a09841-bb56-46ca-9672-0c5f334965b6 62839-3904 HUMAN OTC DRUG Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20130501 OTC MONOGRAPH FINAL part352 NSE Products, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 62839-6201_c946379b-d061-4318-b07f-30ad494bef58 62839-6201 HUMAN OTC DRUG Nu Skin Sunright Lip Balm Broad Spectrum SPF 15 Octinoxate, Avobenzone, and Octocrylene STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part352 NSE Products, Inc. OCTINOXATE; AVOBENZONE; OCTOCRYLENE 75; 30; 27.9 mg/mL; mg/mL; mg/mL N 20181231 62839-6745_3084098a-cb9b-4053-a28c-570bed6e5082 62839-6745 HUMAN OTC DRUG Epoch Ava Puhi Moni Anti-Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20170208 OTC MONOGRAPH FINAL part358H NSE Products, Inc. PYRITHIONE ZINC 65.7 g/1000mL N 20181231 62847-001_3acb805d-4fe0-4f56-9c7d-a4c2bd9eb8aa 62847-001 HUMAN PRESCRIPTION DRUG Vibativ telavancin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091105 NDA NDA022110 Theravance Biopharma R&D, Inc. TELAVANCIN HYDROCHLORIDE 15 mg/mL Lipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [Chemical/Ingredient] N 20181231 62847-002_3acb805d-4fe0-4f56-9c7d-a4c2bd9eb8aa 62847-002 HUMAN PRESCRIPTION DRUG Vibativ telavancin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091105 NDA NDA022110 Theravance Biopharma R&D, Inc. TELAVANCIN HYDROCHLORIDE 15 mg/mL Lipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [Chemical/Ingredient] N 20181231 62856-001_4adb96d7-0bc9-4bc1-9595-107557966ff6 62856-001 HUMAN PRESCRIPTION DRUG Hexalen altretamine CAPSULE ORAL 19901226 NDA NDA019926 Eisai Inc. ALTRETAMINE 50 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 62856-243_0cd29b30-3459-4572-a114-c2603227175e 62856-243 HUMAN PRESCRIPTION DRUG AcipHex rabeprazole sodium TABLET, DELAYED RELEASE ORAL 19990819 NDA NDA020973 Eisai Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 62856-245_db4a61a7-7f21-479b-a575-d452434313dc 62856-245 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 19961125 NDA NDA020690 Eisai Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 62856-246_db4a61a7-7f21-479b-a575-d452434313dc 62856-246 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 19961125 NDA NDA020690 Eisai Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 62856-247_db4a61a7-7f21-479b-a575-d452434313dc 62856-247 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 20100723 NDA NDA022568 Eisai Inc. DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 62856-272_a33a96b4-f178-4071-b357-2ed4ce07bdf8 62856-272 HUMAN PRESCRIPTION DRUG Fycompa perampanel TABLET ORAL 20121022 NDA NDA202834 Eisai Inc. PERAMPANEL 2 mg/1 Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII N 20181231 62856-274_a33a96b4-f178-4071-b357-2ed4ce07bdf8 62856-274 HUMAN PRESCRIPTION DRUG Fycompa perampanel TABLET ORAL 20121022 NDA NDA202834 Eisai Inc. PERAMPANEL 4 mg/1 Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII N 20181231 62856-276_a33a96b4-f178-4071-b357-2ed4ce07bdf8 62856-276 HUMAN PRESCRIPTION DRUG Fycompa perampanel TABLET ORAL 20121022 NDA NDA202834 Eisai Inc. PERAMPANEL 6 mg/1 Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII N 20181231 62856-278_a33a96b4-f178-4071-b357-2ed4ce07bdf8 62856-278 HUMAN PRESCRIPTION DRUG Fycompa perampanel TABLET ORAL 20121022 NDA NDA202834 Eisai Inc. PERAMPANEL 8 mg/1 Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII N 20181231 62856-280_a33a96b4-f178-4071-b357-2ed4ce07bdf8 62856-280 HUMAN PRESCRIPTION DRUG Fycompa perampanel TABLET ORAL 20121022 NDA NDA202834 Eisai Inc. PERAMPANEL 10 mg/1 Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII N 20181231 62856-282_a33a96b4-f178-4071-b357-2ed4ce07bdf8 62856-282 HUMAN PRESCRIPTION DRUG Fycompa perampanel TABLET ORAL 20121022 NDA NDA202834 Eisai Inc. PERAMPANEL 12 mg/1 Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII N 20181231 62856-290_a33a96b4-f178-4071-b357-2ed4ce07bdf8 62856-290 HUMAN PRESCRIPTION DRUG Fycompa perampanel SUSPENSION ORAL 20160430 NDA NDA208277 Eisai Inc. PERAMPANEL .5 mg/mL Noncompetitive AMPA Glutamate Receptor Antagonist [EPC],AMPA Receptor Antagonists [MoA] CIII N 20181231 62856-389_a6102cd9-28c4-49bf-b99b-028f2a09a80a 62856-389 HUMAN PRESCRIPTION DRUG Halaven eribulin mesylate INJECTION INTRAVENOUS 20101115 NDA NDA201532 Eisai Inc. ERIBULIN MESYLATE .5 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 62856-529_5bb86799-5f33-47e6-9209-3cc5963bfa58 62856-529 HUMAN PRESCRIPTION DRUG Belviq lorcaserin hydrochloride hemihydrate TABLET ORAL 20120627 NDA NDA022529 Eisai Inc. LORCASERIN HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin-2c Receptor Agonist [EPC],Serotonin 2c Receptor Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA] CIV N 20181231 62856-535_5bb86799-5f33-47e6-9209-3cc5963bfa58 62856-535 HUMAN PRESCRIPTION DRUG BELVIQ XR lorcaserin hydrochloride hemihydrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160715 NDA NDA208524 Eisai Inc. LORCASERIN HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin-2c Receptor Agonist [EPC],Serotonin 2c Receptor Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA] CIV N 20181231 62856-582_9cd61902-e589-42d9-80da-d2239ef030b7 62856-582 HUMAN PRESCRIPTION DRUG Banzel rufinamide TABLET, FILM COATED ORAL 20081114 NDA NDA021911 Eisai Inc. RUFINAMIDE 200 mg/1 N 20181231 62856-583_9cd61902-e589-42d9-80da-d2239ef030b7 62856-583 HUMAN PRESCRIPTION DRUG Banzel rufinamide TABLET, FILM COATED ORAL 20081114 NDA NDA021911 Eisai Inc. RUFINAMIDE 400 mg/1 N 20181231 62856-584_9cd61902-e589-42d9-80da-d2239ef030b7 62856-584 HUMAN PRESCRIPTION DRUG Banzel rufinamide SUSPENSION ORAL 20110303 NDA NDA201367 Eisai Inc. RUFINAMIDE 40 mg/mL N 20181231 62856-600_6c0cc062-642e-447b-a269-bc8e0f66be98 62856-600 HUMAN PRESCRIPTION DRUG Dacogen decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19960503 20181231 NDA NDA021790 Eisai Inc. DECITABINE 50 mg/20mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 62856-601_a0e51b4f-dd38-4464-84e4-21cfab022f9c 62856-601 HUMAN PRESCRIPTION DRUG Panretin Alitretinoin GEL TOPICAL 20090203 NDA NDA020886 Eisai Inc. ALITRETINOIN 60 mg/60g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 62856-680_02b00d95-379c-4205-9f24-7d73b9186d8b 62856-680 HUMAN PRESCRIPTION DRUG Zonegran zonisamide CAPSULE ORAL 20000327 20181031 NDA NDA020789 Eisai Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62856-681_02b00d95-379c-4205-9f24-7d73b9186d8b 62856-681 HUMAN PRESCRIPTION DRUG Zonegran zonisamide CAPSULE ORAL 20000327 20180731 NDA NDA020789 Eisai Inc. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 62856-705_02a238be-4370-4875-ba01-640d3892a30f 62856-705 HUMAN PRESCRIPTION DRUG Salagen pilocarpine hyrochloride TABLET, FILM COATED ORAL 19940322 NDA NDA020237 Eisai Inc. PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 62856-708_948f83bf-3b18-48ef-b99e-8165632453e5 62856-708 HUMAN PRESCRIPTION DRUG Lenvima Lenvatinib CAPSULE ORAL 20160513 NDA NDA206947 Eisai Inc. LENVATINIB 4 mg/1 Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA] N 20181231 62856-710_948f83bf-3b18-48ef-b99e-8165632453e5 62856-710 HUMAN PRESCRIPTION DRUG Lenvima Lenvatinib CAPSULE ORAL 20150213 NDA NDA206947 Eisai Inc. LENVATINIB 10 mg/1 Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA] N 20181231 62856-714_948f83bf-3b18-48ef-b99e-8165632453e5 62856-714 HUMAN PRESCRIPTION DRUG Lenvima Lenvatinib KIT 20150213 NDA NDA206947 Eisai Inc. N 20181231 62856-718_948f83bf-3b18-48ef-b99e-8165632453e5 62856-718 HUMAN PRESCRIPTION DRUG Lenvima Lenvatinib KIT 20160513 NDA NDA206947 Eisai Inc. N 20181231 62856-720_948f83bf-3b18-48ef-b99e-8165632453e5 62856-720 HUMAN PRESCRIPTION DRUG Lenvima Lenvatinib CAPSULE ORAL 20150213 NDA NDA206947 Eisai Inc. LENVATINIB 10 mg/1 Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA] N 20181231 62856-724_948f83bf-3b18-48ef-b99e-8165632453e5 62856-724 HUMAN PRESCRIPTION DRUG Lenvima Lenvatinib KIT 20150213 NDA NDA206947 Eisai Inc. N 20181231 62856-775_02a238be-4370-4875-ba01-640d3892a30f 62856-775 HUMAN PRESCRIPTION DRUG Salagen pilocarpine hyrochloride TABLET, FILM COATED ORAL 19940322 NDA NDA020237 Eisai Inc. PILOCARPINE HYDROCHLORIDE 7.5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 62856-796_bfdbd210-182f-4d0b-8004-e815bab26444 62856-796 HUMAN PRESCRIPTION DRUG AKYNZEO Netupitant and Palonosetron CAPSULE ORAL 20141013 20180531 NDA NDA205718 Eisai Inc. NETUPITANT; PALONOSETRON 300; .5 mg/1; mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 62856-797_e3f0e77b-f3a8-40b4-bc25-499607a4e378 62856-797 HUMAN PRESCRIPTION DRUG Aloxi palonosetron hydrochloride INJECTION INTRAVENOUS 20140528 NDA NDA021372 Eisai Inc. PALONOSETRON HYDROCHLORIDE .25 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 62856-798_e3f0e77b-f3a8-40b4-bc25-499607a4e378 62856-798 HUMAN PRESCRIPTION DRUG Aloxi palonosetron hydrochloride INJECTION INTRAVENOUS 20140528 NDA NDA021372 Eisai Inc. PALONOSETRON HYDROCHLORIDE .075 mg/1.5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 62856-831_db4a61a7-7f21-479b-a575-d452434313dc 62856-831 HUMAN PRESCRIPTION DRUG Aricept ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20041018 NDA NDA021720 Eisai Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 62856-832_db4a61a7-7f21-479b-a575-d452434313dc 62856-832 HUMAN PRESCRIPTION DRUG Aricept ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20041018 NDA NDA021720 Eisai Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 62858-101_2f822bdd-6cbc-46f7-b3e1-5e84a2dd6fd3 62858-101 HUMAN OTC DRUG NAIL RENEW TOLNAFTATE LIQUID TOPICAL 20140322 OTC MONOGRAPH FINAL part333C NailRenew TOLNAFTATE 1 g/100mL E 20171231 62864-662_26e10080-d37b-4994-e054-00144ff8d46c 62864-662 HUMAN OTC DRUG Truly Radiant Whitening and Strengthening Rinse Sodium Fluoride 0.02% LIQUID ORAL 20141023 OTC MONOGRAPH FINAL part355 Church & Dwight Canada Corp SODIUM FLUORIDE .2 mg/mL N 20181231 62864-665_21219839-8020-49e5-e054-00144ff88e88 62864-665 HUMAN OTC DRUG Truly Radiant Whitening and Strengthening Rinse CLEAN AND FRESH Sodium Fluoride 0.02% LIQUID ORAL 20151002 OTC MONOGRAPH FINAL part355 Church & Dwight Canada Corp SODIUM FLUORIDE .2 mg/mL N 20181231 62864-759_061840ed-24f2-0b4e-e054-00144ff8d46c 62864-759 HUMAN OTC DRUG Orajel Alcohol Free Antiseptic Rinse For All Mouth Sores Hydrogen Peroxide 1.5%, Menthol 0.1% LIQUID ORAL 20141101 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Canada Corp HYDROGEN PEROXIDE; MENTHOL 1.5; 1 mL/mL; mg/mL N 20181231 62864-760_0618c1d8-5c91-1e88-e054-00144ff8d46c 62864-760 HUMAN OTC DRUG Orajel Antiseptic Rinse For All Mouth Sores Hydrogen Peroxide 1.5%, Menthol 0.1% LIQUID ORAL 20141101 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Canada Corp. HYDROGEN PEROXIDE; MENTHOL 1.5; 1 mL/mL; mg/mL N 20181231 62864-764_5e20d274-d04b-400c-e053-2991aa0a1b69 62864-764 HUMAN OTC DRUG Orajel Toothache Rinse Benzyl Alcohol, Zinc Chloride LIQUID TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part356 Church & Dwight Canada Corp. BENZYL ALCOHOL; ZINC CHLORIDE 2.91; 1.62 mg/mL; mg/mL N 20181231 62864-901_26f35633-9cd6-6cf4-e054-00144ff8d46c 62864-901 HUMAN OTC DRUG ARRID XX Roll On Antiperspirant Deodorant Regular Aluminum Chlorohydrate LIQUID TOPICAL 19960716 OTC MONOGRAPH FINAL part350 .Church & Dwight Canada Corp ALUMINUM CHLOROHYDRATE 16 1/100mL N 20181231 62864-902_f91001e0-66a2-494c-9faf-96bb62c248bc 62864-902 HUMAN OTC DRUG ARRID Extra Dry Antiperspirant Deodorant Aluminum Sesquichlorohydrate 17% CREAM TOPICAL 19951108 OTC MONOGRAPH FINAL part350 Church & Dwight Canada Corp. ALUMINUM SESQUICHLOROHYDRATE 170 mg/g N 20181231 62864-903_f440cc78-ae2c-4a0e-a36d-eb9a22c55349 62864-903 HUMAN OTC DRUG Baby Orajel Naturals for Teething Pain Relief Calcarea phosphorica, Coffea cruda, Chamomilla TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20110615 UNAPPROVED HOMEOPATHIC Church & Dwight Canada Corp. TRIBASIC CALCIUM PHOSPHATE; ARABICA COFFEE BEAN; MATRICARIA RECUTITA 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 62864-909_2171d5ca-c0aa-5ec7-e054-00144ff88e88 62864-909 HUMAN OTC DRUG Orajel Anticavity Fluoride Rinse Alcohol and Sugar Free Sodium Fluoride LIQUID DENTAL 20151005 OTC MONOGRAPH FINAL part355 Church & Dwight Canada Corp. SODIUM FLUORIDE .2 mg/mL N 20181231 62864-910_317712d6-1516-04d1-e054-00144ff88e88 62864-910 HUMAN OTC DRUG Orajel Anticavity Fluoride Rinse Alcohol and Sugar Free Sodium Fluoride LIQUID DENTAL 20151005 OTC MONOGRAPH FINAL part355 Church & Dwight Canada Corp. SODIUM FLUORIDE .2 mg/mL N 20181231 62868-221_0d118afd-348a-4981-9ce5-34aa052333f0 62868-221 HUMAN OTC DRUG GKhair Anti-Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20140409 OTC MONOGRAPH FINAL part358H Van Tibolli Beauty Corp. PYRITHIONE ZINC 1 g/100mL E 20171231 62870-000_5fc89013-20e4-4715-a9ba-c421243eb534 62870-000 HUMAN OTC DRUG Agropharma Isopropyl Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333A AGROPHARMA LABORATORIES INC ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 62870-041_0ea6926b-0864-40ce-b576-68b3a2313e25 62870-041 HUMAN OTC DRUG Agropharma Isopropyl Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20130917 OTC MONOGRAPH NOT FINAL part333A AGROPHARMA LABORATORIES INC ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 62872-766_ef9dbeb6-6506-4f0d-a3c0-10c95a7b3e03 62872-766 HUMAN OTC DRUG TOM FORD TRACELESS FOUNDATION SPF 15 OCTINOXATE LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 ESTEE LAUDER N.V. OCTINOXATE 2.2 mL/100mL E 20171231 62874-005_27ede3b3-4b21-4a71-a6cd-9dbbff8a2161 62874-005 HUMAN OTC DRUG VITAMIN E DAY SPF 15 OCTISALATE, AVOBENZONE CREAM TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 JO MALONE LTD OCTISALATE; AVOBENZONE 5; 3 mL/100mL; mL/100mL E 20171231 62874-995_aefb9f8c-1f64-4e3a-ba7a-eb079910e6f6 62874-995 HUMAN OTC DRUG VITAMIN E LIP CONDITIONER SPF 15 OCTINOXATE, OCTISALATE CREAM TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part352 JO MALONE LTD, Distr. OCTINOXATE; OCTISALATE 7.5; 3.5 mL/100mL; 1/100mL E 20171231 62890-001_741511de-87ca-4c22-a29b-211e3a227e50 62890-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140324 UNAPPROVED MEDICAL GAS Med-Systems, Inc. OXYGEN 99 L/100L E 20171231 62891-123_b5439ef9-db5e-4223-88db-8a64d0f2e8eb 62891-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Para Pharm, Inc. dba Medical Pharmacy OXYGEN 99 L/100L E 20171231 62900-4012_8fbf2be8-d7eb-4c1f-b99e-a08a0e247e72 62900-4012 HUMAN OTC DRUG Gripmax Acetaminophen, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide TABLET ORAL 20140601 OTC MONOGRAPH NOT FINAL part343 Unipharm, Inc. ACETAMINOPHEN; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 325; 25; 10.5 mg/1; mg/1; mg/1 N 20181231 62902-0001_2d0a52ac-b6c3-4625-8532-9b29d1b203c9 62902-0001 HUMAN OTC DRUG Lean Love Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Brain (Suis), Hepar Suis, Methylcobalamin, Pancreas Suis, Kidney (Suis), Stomach (Suis), AACG-A, AACG-B, Calcarea Carbonica, Gambogia Gelsemium, Sempervirens Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto-DHEA (Dehydroepiandrosterone), ATP (Adenosinum Triphosphoricum Dinatrum), Glucagon, Insulinum, Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20140522 20190513 UNAPPROVED HOMEOPATHIC Intentional Nourishment CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; METHYLCOBALAMIN; SUS SCROFA PANCREAS; PORK KIDNEY; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN HUMAN; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62902-0002_be977dd0-213d-49b6-8e02-0b871a074645 62902-0002 HUMAN OTC DRUG Craving and Appetite Ease Acetyl Coenzyme A, Adenosinum Triphosphoricum Dinatrum, Adrenal Cortex (Suis), Bacopa Speciosa, Dopamine Hydrochloride, Equol, Gambogia, Oxytocin Acetate, Rhodiola, Stomach (Suis), Thyroidinum (Suis), Chininum Sulphuricum, Cina, Iodium, Lycopodium Clavatum, Phosphorus, Serotonin (Hydrochloride), Morgan Gaertner LIQUID ORAL 20160824 UNAPPROVED HOMEOPATHIC Intentional Nourishment ACETYL COENZYME A; ADENOSINE TRIPHOSPHATE DISODIUM; SUS SCROFA ADRENAL CORTEX; BACOPA MONNIERI WHOLE; DOPAMINE HYDROCHLORIDE; EQUOL, (+/-)-; GAMBOGE; OXYTOCIN ACETATE; SEDUM ROSEUM WHOLE; SUS SCROFA STOMACH; SUS SCROFA THYROID; QUININE SULFATE; ARTEMISIA CINA PRE-FLOWERING TOP; IODINE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SEROTONIN HYDROCHLORIDE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62902-0003_bdfba839-b7cb-41dd-b264-bca8e1717329 62902-0003 HUMAN OTC DRUG Metabolic Rewire Support Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Gambogia, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto (3-Acetyl-7-Oxo-Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (Suis), Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20151012 UNAPPROVED HOMEOPATHIC Intentional Nourishment CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; GAMBOGE; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62902-0004_f97c5831-9406-4ad3-8c13-2a2aee077001 62902-0004 HUMAN OTC DRUG HGH Vibrancy Agnus Castus, Ambra Grisea, Conium Maculatum, Apiolum, Estradiol, Estriol, Folliculinum, L-Dopa, Melatonin, Testosterone, Alpha-Lipoicum Acidum, Adenosinum Triphosphoricum Dinatrum, Coenzyme A, Ubidecarenonum, Nadidum, Sarcolacticum Acidum, Baryta Carbonica, Selenium Metallicum, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus (Suis), Lymph Node(Suis), Medulla Ossis Suis, Oophorinum (Suis), Orchitinum (Suis), Pancreas Suis, Spleen (Suis) LIQUID ORAL 20151012 UNAPPROVED HOMEOPATHIC Intentional Nourishment CHASTE TREE; AMBERGRIS; CONIUM MACULATUM FLOWERING TOP; APIOLE (PARSLEY); ESTRADIOL; ESTRIOL; ESTRONE; LEVODOPA; MELATONIN; TESTOSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; .ALPHA.-LIPOIC ACID; COENZYME A; NADIDE; LACTIC ACID, L-; UBIDECARENONE; BARIUM CARBONATE; SELENIUM; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA LYMPH; SUS SCROFA BONE MARROW; SUS SCROFA OVARY; SUS SCROFA TESTICLE; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SOMATROPIN; PROTEUS MORGANII 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62902-0005_57f48e35-2562-41f7-b725-6ce352793e45 62902-0005 HUMAN OTC DRUG Clean Sweep Formula 1 Acetylcholine Chloride, Adrenalinum, Dopamine Hydrochloride, GABA, Norepinephrine, Octopamine (Hydrochloride), Serotonin (Hydrochloride), Taurine, Adenosinum Cyclophosphoricum, Cerebrum (Suis), Diencephalon (Suis), Pineal Gland (Suis), Thalamus Opticus, LIQUID ORAL 20170509 UNAPPROVED HOMEOPATHIC Intentional Nourishment ACETYLCHOLINE CHLORIDE; EPINEPHRINE; DOPAMINE HYDROCHLORIDE; .GAMMA.-AMINOBUTYRIC ACID; NOREPINEPHRINE; OCTOPAMINE HYDROCHLORIDE; SEROTONIN HYDROCHLORIDE; TAURINE; ADENOSINE CYCLIC PHOSPHATE; SUS SCROFA CEREBRUM; SUS SCROFA DIENCEPHALON; SUS SCROFA PINEAL GLAND; SUS SCROFA THALAMUS LATERAL GENICULATE NUCLEUS 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 62902-0006_16900b41-9825-4d78-ba4e-247590dd8ca9 62902-0006 HUMAN OTC DRUG Clean Sweep Formula 2 Berberis Vulgaris, Cimicifuga Racemosa, Cinchona Officinalis, Colocynthis, Ledum Palustre, Ranunculus Bulbosus, Aesculus Hippocastanum, Cuprum Aceticum, Nadidum, Natrum Oxalaceticum, Nicotinamidum, Picricum Acidum, Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Alpha-Lipoicum Acidum, Ammonium Muriaticum, Cartilago Suis, Discus Intervertebralis Suis, Silicea, Argentum Metallicum, Calcarea Phosphorica, Funiculus Umbilicalis Suis, Glandula Suprarenalis Suis, Gnaphalium Polycephalum LIQUID ORAL 20170510 UNAPPROVED HOMEOPATHIC Intentional Nourishment BERBERIS VULGARIS ROOT BARK; BLACK COHOSH; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; RHODODENDRON TOMENTOSUM LEAFY TWIG; RANUNCULUS BULBOSUS; HORSE CHESTNUT; CUPRIC ACETATE; NADIDE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; PICRIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; THIOCTIC ACID; AMMONIUM CHLORIDE; SUS SCROFA CARTILAGE; SUS SCROFA INTERVERTEBRAL DISC; SILICON DIOXIDE; SILVER; TRIBASIC CALCIUM PHOSPHATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA ADRENAL GLAND; PSEUDOGNAPHALIUM OBTUSIFOLIUM; SUS SCROFA BONE MARROW; MERCURIC OXIDE; PANTOTHENIC ACID; SULFUR; ENTEROBACTER CLOACAE; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII; PROTEUS VULGARIS 4; 4; 4; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 28; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62902-0007_3e41f916-b256-4957-bb0f-178ef46cfad7 62902-0007 HUMAN OTC DRUG Clean Sweep Formula 3 Ceanothus Americanus, Veratrum Album, Anacardium Orientale, Argentum Nitricum, Condurango, Hydrastis Canadensis, Momordica Balsamina, Oxalis Acetosella, Pulsatilla (Vulgaris), Bile Duct (Suis), Colon (Suis), Duodenum (Suis), Esophagus (Suis), Eye (Suis), Gallbladder (Suis), Ileum (Suis), Intestine (Suis), Ipecacuanha, Jejunum (Suis), Kali Bichromicum, Lung (Suis), Mucosa Nasalis Suis, Natrum Oxalaceticum, Oral Mucosa (Suis), Pancreas Suis, Phosphorus, Rectal Mucosa (Suis), Stomach (Suis) LIQUID ORAL 20170510 UNAPPROVED HOMEOPATHIC Intentional Nourishment CEANOTHUS AMERICANUS LEAF; VERATRUM ALBUM ROOT; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; MARSDENIA CONDURANGO BARK; GOLDENSEAL; MOMORDICA BALSAMINA IMMATURE FRUIT; OXALIS ACETOSELLA LEAF; ANEMONE PULSATILLA; SUS SCROFA BILE DUCT; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA ESOPHAGUS; SUS SCROFA EYE; SUS SCROFA GALLBLADDER; SUS SCROFA ILEUM; PORK INTESTINE; IPECAC; SUS SCROFA JEJUNUM; POTASSIUM DICHROMATE; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; SODIUM DIETHYL OXALACETATE; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; SUS SCROFA RECTAL MUCOSA; SUS SCROFA STOMACH; SULFUR; YEAST MANNAN; ATROPA BELLADONNA; WOOD CREOSOTE; LACHESIS MUTA VENOM; MANDRAGORA OFFICINARUM ROOT; SUS SCROFA URINARY BLADDER; SHIGELLA DYSENTERIAE 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62902-0008_68dda16a-ac1c-48a5-8c59-d0c0dab75b14 62902-0008 HUMAN OTC DRUG Clean Sweep Formula 4 Carduus Marianus, Chelidonium Majus, Cinchona Officinalis, Lycopodium Clavatum, Taraxacum Officinale, Veratrum Album, Avena Sativa, Cynara Scolymus, Methylcobalamin, Menadione, alpha-Lipoicum Acidum, Hepar Suis, Colon (Suis), Duodenum (Suis), Gallbladder (Suis), Intestine (Suis), Lymph Node (Suis), Pancreas Suis, Thymus, alpha-Ketoglutaricum Acidum, Cholesterinum, Formicum Acidum, Glyoxal Trimer Dihydrate, Histaminum Hydrochloricum, Malicum Acidum, Natrum Oxalaceticum, Sulphur, Calcarea Carbonica LIQUID ORAL 20170511 UNAPPROVED HOMEOPATHIC Intentional Nourishment MILK THISTLE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT; AVENA SATIVA FLOWERING TOP; CYNARA SCOLYMUS LEAF; METHYLCOBALAMIN; MENADIONE; THIOCTIC ACID; PORK LIVER; SUS SCROFA COLON; SUS SCROFA DUODENUM; SUS SCROFA GALLBLADDER; PORK INTESTINE; SUS SCROFA LYMPH; SUS SCROFA PANCREAS; SUS SCROFA THYMUS; OXOGLURIC ACID; CHOLESTEROL; FORMIC ACID; GLYOXAL TRIMER DIHYDRATE; HISTAMINE DIHYDROCHLORIDE; MALIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; OYSTER SHELL CALCIUM CARBONATE, CRUDE; OROTIC ACID; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; PROTEUS MORGANII 3; 4; 4; 4; 4; 4; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 13; 28; 7; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62902-0009_792a8cbd-4368-48d9-bd92-be7878effd22 62902-0009 HUMAN OTC DRUG Clean Sweep Formula 5 Solidago Virgaurea, Baptisia Tinctoria, Berberis Vulgaris, Equisetum Hyemale, Argentum Nitricum, Cantharis, Capsicum Annuum, Cuprum Sulphuricum, Orthosiphon Stamineus, Pareira Brava, Sarsaparilla (Smilax Regelii), Terebinthina, Apis Venenum Purum, Barosma (Betulina), Mercurius Corrosivus, Pyelon (Suis), Ureter (Suis), Urethra (Suis), Urinary Bladder (Suis), Glyoxal Trimer Dihydrate, Hepar Sulphuris Calcareum, Natrum Pyruvicum, Quercetin, Colibacillinum Cum Natrum Muriaticum, Dysentery Bacillus LIQUID ORAL 20170512 UNAPPROVED HOMEOPATHIC Intentional Nourishment SOLIDAGO VIRGAUREA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; SILVER NITRATE; LYTTA VESICATORIA; CAPSICUM; CUPRIC SULFATE; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; TURPENTINE OIL; APIS MELLIFERA VENOM; AGATHOSMA BETULINA LEAF; MERCURIC CHLORIDE; SUS SCROFA RENAL PELVIS; SUS SCROFA URETER; SUS SCROFA URETHRA; SUS SCROFA URINARY BLADDER; GLYOXAL TRIMER DIHYDRATE; CALCIUM SULFIDE; SODIUM PYRUVATE; QUERCETIN; ESCHERICHIA COLI; SHIGELLA DYSENTERIAE 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 15; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62902-0010_492f0033-ee2b-457a-a96d-3f5e00a727c1 62902-0010 HUMAN OTC DRUG Clean Sweep Formula 6 Conium Maculatum, Dulcamara, Echinacea (Angustifolia), Aesculus Hippocastanum, Antimonium Tartaricum, Ascorbic Acid, Coccus Cacti, Galium Aparine, Gentiana Lutea, Geranium Robertianum, Pulsatilla (Vulgaris), Sarcolacticum Acidum, Lymph Node (Suis), Sulphur, Glandula Suprarenalis Suis, L-Phenylalanine, Calcarea Phosphorica, Ferrum Phosphoricum, Hepar Suis, Hypothalamus (Suis), Spleen (Suis), Cortisone Aceticum, Mercurius Solubilis, Baryta Carbonica, Glyphosate, Funiculus Umbilicalis Suis LIQUID ORAL 20170512 UNAPPROVED HOMEOPATHIC Intentional Nourishment CONIUM MACULATUM FLOWERING TOP; SOLANUM DULCAMARA TOP; ECHINACEA ANGUSTIFOLIA; HORSE CHESTNUT; ANTIMONY POTASSIUM TARTRATE; ASCORBIC ACID; PROTORTONIA CACTI; GALIUM APARINE; GENTIANA LUTEA ROOT; PULSATILLA VULGARIS; LACTIC ACID, L-; SUS SCROFA LYMPH; SULFUR; SUS SCROFA ADRENAL GLAND; PHENYLALANINE; TRIBASIC CALCIUM PHOSPHATE; FERRUM PHOSPHORICUM; PORK LIVER; SUS SCROFA HYPOTHALAMUS; SUS SCROFA SPLEEN; CORTISONE ACETATE; MERCURIUS SOLUBILIS; BARIUM CARBONATE; GLYPHOSATE; SUS SCROFA UMBILICAL CORD; SUS SCROFA TONSIL; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; LIOTHYRONINE; SUS SCROFA BONE MARROW; BISPHENOL A; BROMINE; CHLORINE; HYDROFLUORIC ACID; IODINE; ESCHERICHIA COLI 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 10; 10; 10; 10; 10; 13; 13; 28; 1000; 6; 6; 9; 10; 12; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 62902-0011_bc1f5b81-067f-4136-8203-5ce6f53f5396 62902-0011 HUMAN OTC DRUG Lean Love Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Cerebrum Suis, Hepar Suis, Methylcobalamin, Pancreas Suis, Kidney (Suis), Stomach (Suis), AACG-A, AACG-B, Calcarea Carbonica, Gambogia Gelsemium, Sempervirens Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto (3-acetyl-7-oxo-dehyroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (Suis), Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20170509 UNAPPROVED HOMEOPATHIC Intentional Nourishment CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; SUS SCROFA CEREBRUM; PORK LIVER; METHYLCOBALAMIN; SUS SCROFA PANCREAS; PORK KIDNEY; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 62908-011_7eebb3b0-6583-47fe-8679-e894f1740645 62908-011 HUMAN OTC DRUG NOEVIR RAYSELA ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20100101 UNAPPROVED DRUG OTHER NOEVIR USA INC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 14250; 7500; 2070 mg/100g; mg/100g; mg/100g E 20171231 62908-012_db90c8b8-d187-4480-be9b-95273150a11d 62908-012 HUMAN OTC DRUG NOEVIR N5 ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE POWDER TOPICAL 20100101 UNAPPROVED DRUG OTHER NOEVIR USA INC ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 144; 2000; 13800 mg/100g; mg/100g; mg/100g E 20171231 62908-013_b919b1fd-74b9-4fee-ae43-ff87be7ed754 62908-013 HUMAN OTC DRUG NOEVIR 5 TREATMENT LIQUID FOUNDATION LX OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20100801 UNAPPROVED DRUG OTHER NOEVIR USA INC OCTINOXATE; TITANIUM DIOXIDE 1000; 7490 mg/100g; mg/100g E 20171231 62914-1000_fe6dce1b-2e43-4e60-971e-9b98ce646088 62914-1000 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS Medassure Inc. OXYGEN 99 L/100L E 20171231 62917-065_91199a78-e92e-487e-8417-f0c5ee60d6d2 62917-065 HUMAN OTC DRUG Theraplex HEALING EMOLLIENT PETROLATUM CREAM TOPICAL 20151023 OTC MONOGRAPH FINAL part347 The Theraplex Company, LLC PETROLATUM 65 g/100g N 20181231 62917-065_afb302c0-1b23-4001-aa91-6c1e836094b5 62917-065 HUMAN OTC DRUG Theraplex Healing Emollient Petrolatum CREAM CUTANEOUS 20170501 OTC MONOGRAPH FINAL part347 The Theraplex Company, LLC PETROLATUM 65 g/100g N 20181231 62917-065_bfa9931f-9f45-4c95-87f5-65ed93d295f5 62917-065 HUMAN OTC DRUG Theraplex Healing Emollient Petrolatum CREAM CUTANEOUS 20170501 OTC MONOGRAPH FINAL part347 The Theraplex Company, LLC PETROLATUM 65 g/100g N 20181231 62917-350_19aede07-cd9e-4f75-9559-45cb9d65d37c 62917-350 HUMAN OTC DRUG Theraplex Eczema Therapy Moisturizing skin protectant Colloidal Oatmeal LOTION TOPICAL 20131101 OTC MONOGRAPH FINAL part347 The Theraplex Company, LLC OATMEAL 1 g/100g N 20181231 62932-142_9b071443-408b-494e-b7a9-485d147b36bf 62932-142 HUMAN OTC DRUG Aunt Bees SPF 35 Cherry Lip Balm Lip Balm SPF 35 SALVE TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Private Label Select OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 75; 50; 40; 10 g/1000g; g/1000g; g/1000g; g/1000g CV E 20171231 62932-143_111c9156-2829-1694-e054-00144ff8d46c 62932-143 HUMAN OTC DRUG Aunt Bees Five Flavors Pineapple Coconut Lip Balm Lip Balm SPF 35 SALVE TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Private Label Select OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 75; 50; 40; 10 g/1000g; g/1000g; g/1000g; g/1000g E 20171231 62932-144_111c9156-282a-1694-e054-00144ff8d46c 62932-144 HUMAN OTC DRUG Aunt Bees Five Flavors Sweet Almond Lip Balm Lip Balm SPF 35 SALVE TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Private Label Select OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 75; 50; 40; 10 g/1000g; g/1000g; g/1000g; g/1000g E 20171231 62932-145_111c9156-282b-1694-e054-00144ff8d46c 62932-145 HUMAN OTC DRUG Aunt Bees Five Flavors Tangelo Lip Balm Lip Balm SPF 35 SALVE TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Private Label Select OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 75; 50; 40; 10 g/1000g; g/1000g; g/1000g; g/1000g E 20171231 62932-146_111c9156-2828-1694-e054-00144ff8d46c 62932-146 HUMAN OTC DRUG Aunt Bees Five Flavors Wintermint Lip Balm Lip Balm SPF 35 SALVE TOPICAL 20100101 OTC MONOGRAPH FINAL part352 Private Label Select OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 75; 50; 40; 10 g/1000g; g/1000g; g/1000g; g/1000g E 20171231 62932-150_4f1a7b76-5f0b-04c4-e054-00144ff88e88 62932-150 HUMAN OTC DRUG SUNSCREEN ZINC OXIDE SUNSCREEN OINTMENT TOPICAL 20160131 OTC MONOGRAPH FINAL part352 Private Label Select Ltd CO ZINC OXIDE 20 g/100g N 20181231 62932-151_4f1a7b76-5f05-04c4-e054-00144ff88e88 62932-151 HUMAN OTC DRUG SUNSCREEN ZINC OXIDE SUNSCREEN OINTMENT TOPICAL 20160131 OTC MONOGRAPH FINAL part352 Private Label Select Ltd CO ZINC OXIDE 20 g/100g N 20181231 62932-152_4f19f41f-3cf0-0119-e054-00144ff8d46c 62932-152 HUMAN OTC DRUG SUNSCREEN ZINC OXIDE SUNSCREEN STICK TOPICAL 20160131 OTC MONOGRAPH FINAL part352 Private Label Select Ltd CO ZINC OXIDE 20 g/100g N 20181231 62932-153_4f1da47d-8adc-00c0-e054-00144ff88e88 62932-153 HUMAN OTC DRUG SUNSCREEN ZINC OXIDE SUNSCREEN STICK TOPICAL 20160131 OTC MONOGRAPH FINAL part352 Private Label Select Ltd CO ZINC OXIDE 20 g/100g N 20181231 62932-154_4fa7a2c1-8e57-3ff9-e054-00144ff8d46c 62932-154 HUMAN OTC DRUG SUNSCREEN ZINC OXIDE SUNSCREEN STICK TOPICAL 20160131 OTC MONOGRAPH FINAL part352 Private Label Select Ltd CO ZINC OXIDE 20 g/100g N 20181231 62932-155_4fa7bffa-2586-5212-e054-00144ff88e88 62932-155 HUMAN OTC DRUG SUNSCREEN ZINC OXIDE SUNSCREEN STICK TOPICAL 20160131 OTC MONOGRAPH FINAL part352 Private Label Select Ltd CO ZINC OXIDE 20 g/100g N 20181231 62935-222_1e24d78d-f78a-4bef-abb7-d9a16d064b31 62935-222 HUMAN PRESCRIPTION DRUG ELIGARD Leuprolide Acetate KIT SUBCUTANEOUS 20020826 NDA NDA021379 TOLMAR PHARMACEUTICALS INC. N 20181231 62935-223_1e24d78d-f78a-4bef-abb7-d9a16d064b31 62935-223 HUMAN PRESCRIPTION DRUG ELIGARD Leuprolide Acetate KIT SUBCUTANEOUS 20020826 NDA NDA021379 TOLMAR PHARMACEUTICALS INC. N 20181231 62935-302_1e24d78d-f78a-4bef-abb7-d9a16d064b31 62935-302 HUMAN PRESCRIPTION DRUG ELIGARD Leuprolide Acetate KIT SUBCUTANEOUS 20030226 NDA NDA021488 TOLMAR PHARMACEUTICALS INC. N 20181231 62935-303_1e24d78d-f78a-4bef-abb7-d9a16d064b31 62935-303 HUMAN PRESCRIPTION DRUG ELIGARD Leuprolide Acetate KIT SUBCUTANEOUS 20030226 NDA NDA021488 TOLMAR PHARMACEUTICALS INC. N 20181231 62935-452_1e24d78d-f78a-4bef-abb7-d9a16d064b31 62935-452 HUMAN PRESCRIPTION DRUG ELIGARD Leuprolide Acetate KIT SUBCUTANEOUS 20050107 NDA NDA021731 TOLMAR PHARMACEUTICALS INC. N 20181231 62935-453_1e24d78d-f78a-4bef-abb7-d9a16d064b31 62935-453 HUMAN PRESCRIPTION DRUG ELIGARD Leuprolide Acetate KIT SUBCUTANEOUS 20050107 NDA NDA021731 TOLMAR PHARMACEUTICALS INC. N 20181231 62935-752_1e24d78d-f78a-4bef-abb7-d9a16d064b31 62935-752 HUMAN PRESCRIPTION DRUG ELIGARD Leuprolide Acetate KIT SUBCUTANEOUS 20020515 NDA NDA021343 TOLMAR PHARMACEUTICALS INC. N 20181231 62935-753_1e24d78d-f78a-4bef-abb7-d9a16d064b31 62935-753 HUMAN PRESCRIPTION DRUG ELIGARD Leuprolide Acetate KIT SUBCUTANEOUS 20020515 NDA NDA021343 TOLMAR PHARMACEUTICALS INC. N 20181231 62936-0042_b82a8839-d9e2-40a7-8e1b-d979f260a110 62936-0042 HUMAN OTC DRUG Laura Lynn Anticavity Whitening plus Mouthwash Sodium Fluoride PASTE DENTAL 20030829 OTC MONOGRAPH FINAL part355 Ingles Market Inc SODIUM FLUORIDE 2.43 mg/g E 20171231 62936-0043_5a32ad45-93cb-4624-b9da-16741c8b14f9 62936-0043 HUMAN OTC DRUG Laura Lynn Extra Whitening Sensitive Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20061206 OTC MONOGRAPH NOT FINAL part356 Ingles Market Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g E 20171231 62936-0279_e16ddb54-1211-4b75-804d-faa0d97e18e3 62936-0279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20160226 OTC MONOGRAPH NOT FINAL part333A Ingles Markets, Inc BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 62936-0370_9d76c589-9778-44d2-8d97-318288e5aeb9 62936-0370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20150610 OTC MONOGRAPH NOT FINAL part333A Ingles Markets, Inc. ALCOHOL 70 mL/100mL N 20181231 62936-0403_ec55b5df-af96-46e1-88ee-271d155285ae 62936-0403 HUMAN OTC DRUG Hand wash Benzalkonium chloride SOAP TOPICAL 20160226 OTC MONOGRAPH NOT FINAL part333A Ingles Markets, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 62936-0575_6cbe50b7-4fbf-459b-8918-803431a2d09d 62936-0575 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part333A Ingles Markets, Inc BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 62942-101_16ad70b8-2eae-60b2-e054-00144ff8d46c 62942-101 HUMAN PRESCRIPTION DRUG DEBACTEROL Canker Sore Pain Relief Phenolsulfonic Acid and Sulfuric Acid SOLUTION TOPICAL 19960901 UNAPPROVED DRUG OTHER EPIEN Medical Inc PHENOLSULFONIC ACID; SULFURIC ACID .5; .3 g/mL; g/mL N 20181231 62956-0001_52d0b25a-43fd-4773-ac0f-20776609a8b5 62956-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000102 UNAPPROVED MEDICAL GAS Physician's Choice Medical, LLC OXYGEN 99 L/100L E 20171231 62973-125_63f0e37d-e6f7-dec5-e053-2991aa0a2244 62973-125 HUMAN PRESCRIPTION DRUG Naproxen NAPROXEN SUSPENSION ORAL 20180127 NDA NDA018965 Entreprises ImportFAB Inc. NAPROXEN 125 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 62973-126_63f0e37d-e72d-dec5-e053-2991aa0a2244 62973-126 HUMAN PRESCRIPTION DRUG Naprosyn NAPROXEN SUSPENSION ORAL 20180127 NDA NDA018965 Entreprises ImportFAB Inc. NAPROXEN 125 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 62973-809_63f0fbec-56a7-52a2-e053-2a91aa0af005 62973-809 HUMAN OTC DRUG Motion Medicine MENTHOL CREAM TOPICAL 20180127 OTC MONOGRAPH NOT FINAL part348 Entreprises ImportFAB Inc. MENTHOL 40 mg/g N 20191231 62980-121_b2acbf19-563c-4995-8ef5-0cee182f2cdf 62980-121 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20150904 ANDA ANDA090073 Vivimed Labs Limited MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 62980-122_b2acbf19-563c-4995-8ef5-0cee182f2cdf 62980-122 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20150904 ANDA ANDA090073 Vivimed Labs Limited MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 62980-123_b2acbf19-563c-4995-8ef5-0cee182f2cdf 62980-123 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride KIT 20150904 ANDA ANDA090073 Vivimed Labs Limited E 20171231 62980-509_03ac4131-0169-49e2-9fd1-325987d906d4 62980-509 HUMAN PRESCRIPTION DRUG Metronidazole 250 mg Metronidazole TABLET, FILM COATED ORAL 20160324 ANDA ANDA070040 Vivimed Labs Limited METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 62980-510_8df3e40a-5de3-4f17-9b35-72f2231fe433 62980-510 HUMAN PRESCRIPTION DRUG Metronidazole 500 mg Metronidazole TABLET, FILM COATED ORAL 20160324 ANDA ANDA070039 Vivimed Labs Limited METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 62980-961_abb76e1d-a0c6-407b-b70c-1d5da87f4902 62980-961 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Vivimed Labs Limited AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 62980-962_f6898322-3e70-4e68-820e-315ae41a4b36 62980-962 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065302 Vivimed Labs Limited AZITHROMYCIN ANHYDROUS 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 62980-964_abb76e1d-a0c6-407b-b70c-1d5da87f4902 62980-964 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 Vivimed Labs Limited AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 62982-002_a43be534-f9e2-4cd4-84bb-bbcc5fa85860 62982-002 HUMAN OTC DRUG Effervescent Pain Relief Fast Relief Aspirin, Citric Acid Monohydrate, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20060922 OTC MONOGRAPH FINAL part343 Deseret Laboratories, Inc. ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 N 20181231 62985-5081_0182d7f1-a37e-45fe-bfad-e213d84844a7 62985-5081 HUMAN OTC DRUG First Aid Antiseptic benzalkonium chloride, benzocaine SPRAY TOPICAL 20140813 OTC MONOGRAPH NOT FINAL part333A First Aid Only BENZALKONIUM CHLORIDE; BENZOCAINE .96; 58.5 g/L; g/L N 20181231 62985-5082_e680e59a-e9c9-46c8-84d9-9cbd0ada4ad2 62985-5082 HUMAN OTC DRUG Burn Lidocaine Hydrochloride SPRAY TOPICAL 20140813 OTC MONOGRAPH NOT FINAL part348 First Aid Only, Inc LIDOCAINE HYDROCHLORIDE 20 g/L N 20181231 62985-5123_51567c0c-0574-4ead-8477-240f490c4059 62985-5123 HUMAN OTC DRUG First Aid Only Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20141126 20180831 OTC MONOGRAPH FINAL part344 First Aid Only, Inc ISOPROPYL ALCOHOL 700 mL/L E 20171231 62985-5124_c0e110ce-fbe7-4a2a-939d-be1201341fa4 62985-5124 HUMAN OTC DRUG First Aid Only Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20141126 20181031 OTC MONOGRAPH NOT FINAL part333A First Aid Only, Inc HYDROGEN PEROXIDE 30 mL/L N 20181231 62985-5125_f37cb8e6-95b5-47f9-862c-ee0fcd00dc1f 62985-5125 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20150610 OTC MONOGRAPH NOT FINAL part348 First Aid Only, Inc HYDROCORTISONE 10 mg/g N 20181231 62990-690_b76a0c0a-cd16-4ff6-b17e-9a42b11ab6f6 62990-690 HUMAN OTC DRUG Acute Care Kit Aconitum Napellus, Antimonium Tartaricum, Apis Mellifica, Arnica Montana, Arsenicum Album, Belladonna, Cantharis, Carbo Vegetabilis, Chamomilla, Cinchona, Gelsemium, Hepar Sulph Calcareum, Hypericum Perforaturm, Ipecacuanha, Kali Bichromicum, Lachesis Mutus, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Rhus Toxicodendron, Urtica Urens PELLET ORAL 20140421 UNAPPROVED HOMEOPATHIC MARPE LLC ACONITUM NAPELLUS; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; LYTTA VESICATORIA; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; HYPERICUM PERFORATUM; IPECAC; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 62995-001_ccd547c1-be1d-4378-9725-854580fede43 62995-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19970901 UNAPPROVED MEDICAL GAS Southern ILlinois Surgical Appliance Co OXYGEN 992 mL/L E 20171231 63002-001_58de352a-4b31-4fce-872c-8d5089818139 63002-001 HUMAN OTC DRUG WSNA Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140430 OTC MONOGRAPH NOT FINAL part333A Advanced Hygienics LLC BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 63002-002_ef6a1c09-8491-4a08-bedc-a67ce00d9e23 63002-002 HUMAN OTC DRUG Byotrol Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140502 OTC MONOGRAPH NOT FINAL part333A Advanced Hygienics LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63002-003_001415e4-c6c6-4505-b5dd-f9baa6182e26 63002-003 HUMAN OTC DRUG PROTECT 8 BENZALKONIUM CHLORIDE LIQUID TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part333A Advanced Hygienics LLC BENZALKONIUM CHLORIDE 1.3 g/mL N 20191231 63002-004_bfc689ba-d7f8-4c16-9a13-4bd7b859bbf5 63002-004 HUMAN OTC DRUG Hand Sanitizer BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20170518 OTC MONOGRAPH NOT FINAL part333A Advanced Hygienics LLC BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 63004-8710_c480c46d-45dc-4952-a2d3-a5d008b80239 63004-8710 HUMAN PRESCRIPTION DRUG H.P. Acthar Repository Corticotropin INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20130107 NDA NDA022432 Mallinckrodt ARD Inc. CORTICOTROPIN 80 [USP'U]/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] N 20181231 63005-1212_634a097f-b143-4029-9902-c64dd21dd3cc 63005-1212 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19991010 UNAPPROVED MEDICAL GAS Quality Home Oxygen, Inc OXYGEN 99 L/100L E 20171231 63010-010_6abd808e-1f03-4211-b294-6f596e2585aa 63010-010 HUMAN PRESCRIPTION DRUG VIRACEPT nelfinavir mesylate TABLET, FILM COATED ORAL 19970314 NDA NDA020779 AGOURON NELFINAVIR MESYLATE 250 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] N 20181231 63010-027_6abd808e-1f03-4211-b294-6f596e2585aa 63010-027 HUMAN PRESCRIPTION DRUG VIRACEPT nelfinavir mesylate TABLET, FILM COATED ORAL 20030430 NDA NDA021503 AGOURON NELFINAVIR MESYLATE 625 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA] N 20181231 63014-1600_d8402f8b-299a-43f7-8fc7-4477f11238d2 63014-1600 HUMAN OTC DRUG SHISEIDO REFRESHING SUN PROTECTION Avobenzone and Octinoxate SPRAY TOPICAL 20040803 OTC MONOGRAPH NOT FINAL part352 SHISEIDO INTERNATIONAL FRANCE AVOBENZONE; OCTINOXATE 3.3; 9.768 g/132g; g/132g E 20171231 63020-049_a628369e-5225-47c4-8445-a674ea6fcb68 63020-049 HUMAN PRESCRIPTION DRUG VELCADE bortezomib INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20030513 NDA NDA021602 Millennium Pharmaceuticals, Inc. BORTEZOMIB 3.5 mg/1 Proteasome Inhibitor [EPC],Proteasome Inhibitors [MoA] N 20181231 63020-078_da385b56-052e-4df2-89c4-643916068070 63020-078 HUMAN PRESCRIPTION DRUG NINLARO ixazomib CAPSULE ORAL 20151120 NDA NDA208462 Millennium Pharmaceuticals, Inc. IXAZOMIB CITRATE 2.3 mg/1 Proteasome Inhibitor [EPC],Proteasome Inhibitors [MoA] N 20181231 63020-079_da385b56-052e-4df2-89c4-643916068070 63020-079 HUMAN PRESCRIPTION DRUG NINLARO ixazomib CAPSULE ORAL 20151120 NDA NDA208462 Millennium Pharmaceuticals, Inc. IXAZOMIB CITRATE 3 mg/1 Proteasome Inhibitor [EPC],Proteasome Inhibitors [MoA] N 20181231 63020-080_da385b56-052e-4df2-89c4-643916068070 63020-080 HUMAN PRESCRIPTION DRUG NINLARO ixazomib CAPSULE ORAL 20151120 NDA NDA208462 Millennium Pharmaceuticals, Inc. IXAZOMIB CITRATE 4 mg/1 Proteasome Inhibitor [EPC],Proteasome Inhibitors [MoA] N 20181231 63020-090_530d4623-063e-49de-99b1-86301d849537 63020-090 HUMAN PRESCRIPTION DRUG Alunbrig brigatinib TABLET, FILM COATED ORAL 20170428 NDA NDA208772 Millennium Pharmaceuticals, Inc. BRIGATINIB 90 mg/1 Kinase Inhibitor [EPC],Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA] N 20181231 63020-113_530d4623-063e-49de-99b1-86301d849537 63020-113 HUMAN PRESCRIPTION DRUG Alunbrig brigatinib TABLET, FILM COATED ORAL 20170428 NDA NDA208772 Millennium Pharmaceuticals, Inc. BRIGATINIB 30 mg/1 Kinase Inhibitor [EPC],Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA] N 20181231 63020-180_530d4623-063e-49de-99b1-86301d849537 63020-180 HUMAN PRESCRIPTION DRUG Alunbrig brigatinib TABLET, FILM COATED ORAL 20170428 NDA NDA208772 Millennium Pharmaceuticals, Inc. BRIGATINIB 180 mg/1 Kinase Inhibitor [EPC],Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA] N 20181231 63020-198_530d4623-063e-49de-99b1-86301d849537 63020-198 HUMAN PRESCRIPTION DRUG Alunbrig brigatinib KIT 20170428 NDA NDA208772 Millennium Pharmaceuticals, Inc. N 20181231 63020-533_d99f0ff0-abfc-4cba-991d-83d04851a548 63020-533 HUMAN PRESCRIPTION DRUG Iclusig ponatinib hydrochloride TABLET, FILM COATED ORAL 20150422 NDA NDA203469 Millennium Pharmaceuticals, Inc. PONATINIB HYDROCHLORIDE 30 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 63020-534_d99f0ff0-abfc-4cba-991d-83d04851a548 63020-534 HUMAN PRESCRIPTION DRUG Iclusig ponatinib hydrochloride TABLET, FILM COATED ORAL 20121214 NDA NDA203469 Millennium Pharmaceuticals, Inc. PONATINIB HYDROCHLORIDE 45 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 63020-535_d99f0ff0-abfc-4cba-991d-83d04851a548 63020-535 HUMAN PRESCRIPTION DRUG Iclusig ponatinib hydrochloride TABLET, FILM COATED ORAL 20121214 NDA NDA203469 Millennium Pharmaceuticals, Inc. PONATINIB HYDROCHLORIDE 15 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20191231 63029-010_a1ba1753-d907-4172-8e06-16e7234d9d5c 63029-010 HUMAN OTC DRUG PediaCare Single Dose Fever Reducer Acetaminophen LIQUID ORAL 20130515 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 63029-049_97122b17-0ff8-4fcd-b5ea-8f6becc692bd 63029-049 HUMAN OTC DRUG Percogesic Extra Strength Acetaminophen and Diphenhydramine CAPSULE, COATED ORAL 20100707 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; DIPHENHYDRAMINE 500; 12.5 mg/1; mg/1 N 20181231 63029-050_d89d64f1-0b97-46d8-96f1-516792498a32 63029-050 HUMAN OTC DRUG Percogesic Original Strength Acetaminophen and Diphenhydramine TABLET, COATED ORAL 20100319 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; DIPHENHYDRAMINE 325; 12.5 mg/1; mg/1 N 20181231 63029-051_cb2e155f-d778-42a3-a54c-30079721e397 63029-051 HUMAN OTC DRUG Percogesic Magnesium Salicylate TABLET, COATED ORAL 20100105 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. MAGNESIUM SALICYLATE 467 mg/1 N 20181231 63029-062_1af3c28a-0ba0-4036-b5c4-51a96dd9ba42 63029-062 HUMAN OTC DRUG Goodys PM Pain Reliever Acetaminophen and Aspirin and Caffeine CAPSULE, COATED ORAL 20120713 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 63029-075_a1ba1753-d907-4172-8e06-16e7234d9d5c 63029-075 HUMAN OTC DRUG PediaCare Single Dose Fever Reducer Acetaminophen LIQUID ORAL 20130515 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 63029-100_ba0adf41-ff2a-47ef-988e-bfd641f39373 63029-100 HUMAN OTC DRUG Little Ouchies Little Remedies Pain Relief Benzocaine and Menthol AEROSOL, SPRAY TOPICAL 20091231 OTC MONOGRAPH NOT FINAL part348 Medtech Products Inc. BENZOCAINE; MENTHOL 200; 50 mg/g; mg/g N 20181231 63029-101_cbac2426-7be1-4f95-888d-a1501871f284 63029-101 HUMAN OTC DRUG Little Remedies Little Colds Mucus Relief Expectorant Melt Aways Guaifenesin GRANULE ORAL 20091231 OTC MONOGRAPH NOT FINAL part356 Medtech Products Inc. GUAIFENESIN 100 mg/1 E 20171231 63029-102_225493ba-a97b-42c9-968d-86923f2715dc 63029-102 HUMAN OTC DRUG Little Colds Sore Throat Relief Melt Aways Benzocaine GRANULE ORAL 20091231 OTC MONOGRAPH FINAL part356 Medtech Products Inc. BENZOCAINE 6 mg/1 E 20171231 63029-103_3c38b8dd-59d0-484a-980d-bb9c27bad873 63029-103 HUMAN OTC DRUG Little Remedies Gas Relief Drops simthicone LIQUID ORAL 20100104 OTC MONOGRAPH FINAL part332 Medtech Products Inc. DIMETHICONE 20 mg/.3mL N 20181231 63029-104_8f978515-46ad-45d2-854f-d424881e1a93 63029-104 HUMAN OTC DRUG Freezone Salicylic Acid LIQUID TOPICAL 19991001 OTC MONOGRAPH FINAL part358F Medtech Products Inc. SALICYLIC ACID 158.4 mg/mL N 20181231 63029-200_005c145b-8928-40f2-8cd0-cd98db85aa34 63029-200 HUMAN OTC DRUG BC Cherry Aspirin and Caffeine POWDER ORAL 20121001 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ASPIRIN; CAFFEINE 845; 65 mg/1; mg/1 N 20181231 63029-201_f2e15fdf-8416-4311-b3d6-daace3458a84 63029-201 HUMAN OTC DRUG BC Aspirin and Caffeine POWDER ORAL 20120601 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ASPIRIN; CAFFEINE 845; 65 mg/1; mg/1 N 20181231 63029-202_090e49b7-a154-43b8-b111-216d2c798eab 63029-202 HUMAN OTC DRUG BC Arthritis Aspirin and Caffeine POWDER ORAL 20120601 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ASPIRIN; CAFFEINE 1000; 65 mg/1; mg/1 N 20181231 63029-211_73997599-2800-4dea-96a2-7197d0b35506 63029-211 HUMAN OTC DRUG Nytol Diphenhydramine HCl TABLET ORAL 20120601 OTC MONOGRAPH FINAL part338 Medtech Products Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63029-213_3b4588b2-fec8-4edc-90f4-0bcd8c962a05 63029-213 HUMAN OTC DRUG Compoz MAXIMUM STRENGTH nighttime sleep aid diphenhydramine hcl CAPSULE, LIQUID FILLED ORAL 20160115 OTC MONOGRAPH FINAL part341 Medtech Products Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 63029-216_4b7c30f9-103b-428f-8704-7f16c2d01d8e 63029-216 HUMAN OTC DRUG BC Sinus Congestion and Pain acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride POWDER ORAL 20160301 OTC MONOGRAPH FINAL part341 Medtech Products Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 650; 4; 10 mg/1; mg/1; mg/1 N 20181231 63029-222_9dd2e61a-21c2-4f74-8071-1702000fde1a 63029-222 HUMAN OTC DRUG Tagamet Cimetidine TABLET ORAL 20120601 NDA NDA020238 Medtech Products Inc. CIMETIDINE 200 mg/1 N 20181231 63029-301_ae512c15-44c0-4c87-8fee-1d144546e121 63029-301 HUMAN OTC DRUG Ecotrin Aspirin TABLET, COATED ORAL 20120601 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ASPIRIN 81 mg/1 E 20171231 63029-302_dcb96269-9bc7-4634-b67b-4732eea3a0ca 63029-302 HUMAN OTC DRUG Ecotrin Regular Strength Aspirin TABLET, COATED ORAL 20120601 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ASPIRIN 325 mg/1 N 20181231 63029-309_7b2f7cbf-9550-4331-9da9-3a58429c565c 63029-309 HUMAN OTC DRUG MOSCO Salicylic Acid LIQUID TOPICAL 19991001 OTC MONOGRAPH FINAL part358F Medtech Products Inc. SALICYLIC ACID 150 mg/mL N 20181231 63029-310_f6a3c62a-b5d2-48cb-a2f9-9ef63c35617b 63029-310 HUMAN OTC DRUG MOSCO Salicylic Acid PLASTER TOPICAL 20100108 OTC MONOGRAPH FINAL part358F Medtech Products Inc. SALICYLIC ACID 4 mg/1 N 20181231 63029-311_13b9f9f0-4169-400f-90d0-4bb060a6d904 63029-311 HUMAN OTC DRUG Ecotrin Aspirin TABLET, COATED ORAL 20120601 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ASPIRIN 81 mg/1 N 20181231 63029-321_14e26db0-7a5e-4f95-8ee3-9c7174410f96 63029-321 HUMAN OTC DRUG DEBROX Carbamide Peroxide LIQUID AURICULAR (OTIC) 20120801 OTC MONOGRAPH FINAL part344 Medtech Products Inc. CARBAMIDE PEROXIDE .065 mg/mL N 20181231 63029-322_e058a340-97b4-4247-9d78-b5da29c40f47 63029-322 HUMAN OTC DRUG DEBROX Carbamide Peroxide LIQUID AURICULAR (OTIC) 20120601 OTC MONOGRAPH FINAL part344 Medtech Products Inc. CARBAMIDE PEROXIDE .065 mg/mL E 20171231 63029-401_431f0c18-2834-4e91-a34c-a5a762a4c07d 63029-401 HUMAN OTC DRUG Little Noses Decongestant Nose Drops Phenylephrine Hydrochloride LIQUID NASAL 20110215 OTC MONOGRAPH FINAL part341 Medtech Products Inc. PHENYLEPHRINE HYDROCHLORIDE .00125 mg/mL N 20181231 63029-406_a53b6795-6307-434d-97fc-eb2ea3809129 63029-406 HUMAN OTC DRUG Little Remedies Sore Throat Pops pectin LOZENGE ORAL 20150601 OTC MONOGRAPH NOT FINAL part356 Medtech Products Inc. PECTIN 5.4 mg/1 N 20181231 63029-411_70ad893b-f9d2-4f27-be9c-897fa955d3cd 63029-411 HUMAN OTC DRUG Chap-et White Petrolatum LIPSTICK TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Medtech Products Inc. PETROLATUM 619.3 mg/g N 20181231 63029-422_70ad893b-f9d2-4f27-be9c-897fa955d3cd 63029-422 HUMAN OTC DRUG Chap-et White Petrolatum LIPSTICK TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Medtech Products Inc. PETROLATUM 619.3 mg/g N 20181231 63029-424_608bd36a-358d-46a1-833b-350f17a7ecde 63029-424 HUMAN OTC DRUG Little Remedies Little Tummys Laxative Drops Sennosides LIQUID ORAL 20100601 OTC MONOGRAPH NOT FINAL part334 Medtech Products Inc. SENNOSIDES 8.8 mg/mL E 20171231 63029-433_70ad893b-f9d2-4f27-be9c-897fa955d3cd 63029-433 HUMAN OTC DRUG Chap-et White Petrolatum LIPSTICK TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Medtech Products Inc. PETROLATUM 619.3 mg/g N 20181231 63029-444_70ad893b-f9d2-4f27-be9c-897fa955d3cd 63029-444 HUMAN OTC DRUG Chap-et White Petrolatum LIPSTICK TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Medtech Products Inc. PETROLATUM 619.3 mg/g N 20181231 63029-455_70ad893b-f9d2-4f27-be9c-897fa955d3cd 63029-455 HUMAN OTC DRUG Chap-et White Petrolatum LIPSTICK TOPICAL 20120601 OTC MONOGRAPH FINAL part347 Medtech Products Inc. PETROLATUM 619.3 mg/g N 20181231 63029-500_8f069db1-017f-4965-a7ca-1cefd6c3adda 63029-500 HUMAN OTC DRUG Gly-Oxide Carbamide Peroxide LIQUID ORAL 20120601 OTC MONOGRAPH NOT FINAL part356 Medtech Products Inc. CARBAMIDE PEROXIDE .1 mg/mL E 20171231 63029-501_27b3aab9-fb4b-405c-8979-8d3202dbb38a 63029-501 HUMAN OTC DRUG Stanback Aspirin and Caffeine POWDER ORAL 20120601 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. CAFFEINE; ASPIRIN 65; 845 mg/1; mg/1 N 20181231 63029-505_d5de69ba-d61a-4aed-816a-9052672a31a1 63029-505 HUMAN OTC DRUG Sominex Max Diphenhydramine HCl TABLET ORAL 20120601 OTC MONOGRAPH FINAL part338 Medtech Products Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 63029-531_9eda3ff1-260d-4242-a5a2-bdee8a7e98bf 63029-531 HUMAN OTC DRUG Outgro Benzocaine LIQUID TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Medtech Products Inc. BENZOCAINE 18.6 g/100mL N 20181231 63029-550_fe2130c2-51b7-4dff-b14a-2c4b44f2fe15 63029-550 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20120601 OTC MONOGRAPH FINAL part332 Medtech Products Inc. DIMETHICONE 410 180 mg/1 N 20181231 63029-555_3cdf8796-6553-46f2-8d57-8e8dd91ce5d0 63029-555 HUMAN OTC DRUG Sominex Diphenhydramine HCl TABLET ORAL 20120601 OTC MONOGRAPH FINAL part338 Medtech Products Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63029-585_fa17ee39-16c8-47c6-a799-135fe06af643 63029-585 HUMAN OTC DRUG Oxipor COAL TAR LOTION TOPICAL 20000721 OTC MONOGRAPH FINAL part358H Medtech Products Inc. COAL TAR 10 mg/mL N 20181231 63029-595_9ca7524a-f84e-4b2a-b798-c6e42a13c855 63029-595 HUMAN OTC DRUG Compound W salicylic acid GEL TOPICAL 20140315 OTC MONOGRAPH FINAL part358B Medtech Products Inc. SALICYLIC ACID .17 g/7g N 20181231 63029-596_8c3e7b75-ffbe-400e-a2e3-10ed1708f56d 63029-596 HUMAN OTC DRUG Compound W Maximum Strength One Step Invisible salicylic acid PLASTER TOPICAL 20140315 OTC MONOGRAPH FINAL part358B Medtech Products Inc. SALICYLIC ACID 4 mg/1 N 20181231 63029-597_a50124b4-c714-4e5e-ab9e-f28d091946c5 63029-597 HUMAN OTC DRUG Compound W Liquid - First Aid salicylic acid LIQUID TOPICAL 20140301 OTC MONOGRAPH FINAL part358B Medtech Products Inc. SALICYLIC ACID 150 mg/mL N 20181231 63029-600_37966fdb-a7fb-4758-a9e6-4b76ee709966 63029-600 HUMAN OTC DRUG Goodys Back and Body Pain Acetaminophen and Asprin POWDER ORAL 20120601 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN 325; 500 mg/1; mg/1 N 20181231 63029-601_d74cce29-359d-4e1d-9555-83a342d86999 63029-601 HUMAN OTC DRUG Little Fevers by Little Remedies Acetaminophen LIQUID ORAL 20100705 OTC MONOGRAPH NOT FINAL part341 Medtech Products Inc. ACETAMINOPHEN .8 mL/mL N 20181231 63029-602_dc78f0a8-43ef-472a-adf8-b6608ccfb316 63029-602 HUMAN OTC DRUG Little Fevers Childrens Fever Pain Reliever Acetaminophen LIQUID ORAL 20100901 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 63029-603_dc78f0a8-43ef-472a-adf8-b6608ccfb316 63029-603 HUMAN OTC DRUG Little Fevers Childrens Fever Pain Reliever Acetaminophen LIQUID ORAL 20100901 OTC MONOGRAPH FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 63029-611_6801eb4c-f713-4383-bcbe-435998bdd7f3 63029-611 HUMAN OTC DRUG Little Fevers Infant Grape Fever/Pain Reliever Acetaminophen LIQUID ORAL 20110701 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 63029-612_74962c65-4d94-4b8f-aee8-9d8917745998 63029-612 HUMAN OTC DRUG Goodys Migraine Relief Acetaminophen, Aspirin and Caffeine CAPSULE, COATED ORAL 20121101 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 E 20171231 63029-620_924cc588-f1ad-460d-9834-f18a11394a35 63029-620 HUMAN OTC DRUG GOODYS Back and Body acetaminophen LIQUID ORAL 20150801 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN 1000 mg/60mL N 20181231 63029-622_ed6e84da-f9ef-47d3-83cd-77d5a7c804d2 63029-622 HUMAN OTC DRUG Little Fevers Infant Berry Fever/Pain Reliever Acetaminophen LIQUID ORAL 20110701 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 63029-629_76e1ade9-4be5-4027-8601-17718a76dbc0 63029-629 HUMAN OTC DRUG Goodys Headache Relief Shot Acetaminophen and Caffeine LIQUID ORAL 20130211 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; CAFFEINE 1000; 65 mg/60mL; mg/60mL N 20181231 63029-633_ffed5ce7-9441-48be-b5bb-e494e7c5020b 63029-633 HUMAN OTC DRUG Goodys Extra Strength Acetaminophen, Aspirin, and Caffeine POWDER ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 260; 520; 32.5 mg/1; mg/1; mg/1 N 20181231 63029-639_76e1ade9-4be5-4027-8601-17718a76dbc0 63029-639 HUMAN OTC DRUG Goodys Headache Relief Shot Acetaminophen and Caffeine LIQUID ORAL 20130211 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; CAFFEINE 1000; 65 mg/60mL; mg/60mL N 20181231 63029-644_ffed5ce7-9441-48be-b5bb-e494e7c5020b 63029-644 HUMAN OTC DRUG Goodys Extra Strength Acetaminophen, Aspirin, and Caffeine POWDER ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 260; 520; 32.5 mg/1; mg/1; mg/1 N 20181231 63029-655_ffed5ce7-9441-48be-b5bb-e494e7c5020b 63029-655 HUMAN OTC DRUG Goodys Extra Strength Acetaminophen, Aspirin, and Caffeine POWDER ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 260; 520; 32.5 mg/1; mg/1; mg/1 N 20181231 63029-661_51034b64-65be-4e7e-acbd-4fadae09cce5 63029-661 HUMAN OTC DRUG Goodys PM Pain Reliever Acetaminophen and Diphenhydramine Citrate POWDER ORAL 20130901 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 N 20181231 63029-662_ffed5ce7-9441-48be-b5bb-e494e7c5020b 63029-662 HUMAN OTC DRUG Goodys Extra Strength Acetaminophen, Aspirin, and Caffeine POWDER ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 260; 520; 32.5 mg/1; mg/1; mg/1 N 20181231 63029-663_6b4c0db1-fb76-4637-93a4-be880dbcb280 63029-663 HUMAN OTC DRUG Goodys Cool Orange Headache Acetaminophen and Aspirin and Caffeine POWDER ORAL 20120601 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 325; 500; 65 mg/1; mg/1; mg/1 N 20181231 63029-664_cc3f69f9-f035-438e-880b-5f94c1f73258 63029-664 HUMAN OTC DRUG GOODYS Extra Strength Headache Mixed Fruit Blast acetaminophen, aspirin, and caffeine POWDER ORAL 20150801 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. CAFFEINE; ACETAMINOPHEN; ASPIRIN 65; 325; 500 mg/1; mg/1; mg/1 N 20181231 63029-677_ffed5ce7-9441-48be-b5bb-e494e7c5020b 63029-677 HUMAN OTC DRUG Goodys Extra Strength Acetaminophen, Aspirin, and Caffeine POWDER ORAL 20131101 OTC MONOGRAPH NOT FINAL part343 Medtech Products Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 260; 520; 32.5 mg/1; mg/1; mg/1 N 20181231 63029-701_2c71e134-8ea7-4c47-b9b9-66830af65ecb 63029-701 HUMAN OTC DRUG Cloverine Petrolatum SALVE TOPICAL 20101019 OTC MONOGRAPH FINAL part347 Medtech Products Inc. PETROLATUM 27.6 g/28.4g N 20181231 63029-811_d1a531a1-b770-45ee-a8c0-4c1b451f3dc8 63029-811 HUMAN OTC DRUG PediaCare Gas Relief Drops Dye Free Simethicone Emulsion and Simethicone LIQUID ORAL 20110801 OTC MONOGRAPH FINAL part332 Medtech Products Inc. SILICON DIOXIDE; DIMETHICONE .011; .211 g/mL; g/mL N 20181231 63029-900_a0a7b7fe-647f-439a-997c-0a6628da3214 63029-900 HUMAN OTC DRUG PediaCare Infants Ibuprofen LIQUID ORAL 20111015 ANDA ANDA079058 Medtech Products Inc. IBUPROFEN 50 mg/1.25mL N 20181231 63029-901_312cc357-0f1c-436d-946f-827e572034ab 63029-901 HUMAN OTC DRUG Dramamine Original Formula Dimenhydrinate TABLET ORAL 20120115 OTC MONOGRAPH FINAL part336 Medtech Products Inc. DIMENHYDRINATE 50 mg/1 N 20181231 63029-902_7d7edc5c-4edc-4e91-9cb4-dfb5f60f99ea 63029-902 HUMAN OTC DRUG Dramamine Orange Dimenhydrinate TABLET, CHEWABLE ORAL 20120115 OTC MONOGRAPH FINAL part336 Medtech Products Inc. DIMENHYDRINATE 50 mg/1 N 20181231 63029-903_9f11e6e6-5005-4593-a206-674b71e6b714 63029-903 HUMAN OTC DRUG Dramamine Less Drowsy Meclizine Hydrochloride TABLET ORAL 20110901 OTC MONOGRAPH FINAL part336 Medtech Products Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 63029-904_548a1cb8-cf67-45fd-855b-b7a160c6e4a4 63029-904 HUMAN OTC DRUG Dramamine for Kids Dimenhydrinate TABLET, CHEWABLE ORAL 20120215 OTC MONOGRAPH FINAL part336 Medtech Products Inc. DIMENHYDRINATE 25 mg/1 N 20181231 63039-1002_4c8935f0-6690-46ff-9843-02af2674274e 63039-1002 HUMAN OTC DRUG E-2 Food Processing Foam Hand Wash BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140331 OTC MONOGRAPH NOT FINAL part333A Chemco Products Company BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63039-1005_4d31a83b-0fea-4782-9e7b-ed75920243eb 63039-1005 HUMAN OTC DRUG Antibacterial Foam Hand Wash CHLOROXYLENOL LIQUID TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333A Chemco Products Company CHLOROXYLENOL 2.5 mg/mL N 20181231 63041-110_91afd078-c606-4aed-b7ea-73eeed69efef 63041-110 HUMAN OTC DRUG IMADA FOUR SEASONS SAFE ANALGESIC BALM Menthol OIL TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part348 LUEN WAH HK MEDICINE LTD MENTHOL 16 g/100mL N 20181231 63041-130_282a7784-36f6-44bd-8c9a-c7edfd08eae2 63041-130 HUMAN OTC DRUG IMADA RED FLOWER ANALGESIC Methyl Salicylate OIL TOPICAL 20140125 OTC MONOGRAPH NOT FINAL part348 LUEN WAH HK MEDICINE LTD METHYL SALICYLATE 60 g/100mL N 20181231 63043-0001_89621a83-6263-4276-953b-99f9bfb221d2 63043-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19961201 UNAPPROVED MEDICAL GAS Home Respiratory Therapy and Equipment, Inc. OXYGEN 99 L/100L E 20171231 63044-030_8faec0ee-57ae-4e12-81d9-86f6728133dc 63044-030 HUMAN OTC DRUG ZIKS ARTHRITIS PAIN RELIEF ZIKS ARTHRITIS PAIN RELIEF CREAM TOPICAL 19991110 OTC MONOGRAPH FINAL part334 Nnodum Pharmaceuticals METHYL SALICYLATE; MENTHOL; CAPSAICIN 6.79; .566; .014 mg/g; mg/g; mg/g E 20171231 63044-150_15eedac9-6f56-4635-bc2b-69618d47a59a 63044-150 HUMAN PRESCRIPTION DRUG Prenatal Vitamins Plus Vitamin A, Vitamin C, Vitamin D-3, Vitamin E, Vitamin B-1, Vitamin B-2, Niacin, Vitamin B-6, Calcium, Iron, Zinc, Copper TABLET ORAL 20160225 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; COPPER 4000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] N 20191231 63044-153_f48327a6-8aa3-41b4-bfa5-a1665174e5ef 63044-153 HUMAN PRESCRIPTION DRUG INATAL ADVANCE INATAL ADVANCE TABLET, COATED ORAL 20050610 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals VITAMIN A; ASCORBIC ACID; CALCIUM CARBONATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; ZINC OXIDE; CUPRIC OXIDE; MAGNESIUM OXIDE; DOCUSATE SODIUM 2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 25; 2; 30; 50 [iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] N 20181231 63044-154_4b22195d-d683-4ced-ae90-2aa395765bf8 63044-154 HUMAN PRESCRIPTION DRUG INATAL Ultra INATAL Ultra TABLET, COATED ORAL 20050620 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals VITAMIN A; ASCORBIC ACID; CALCIUM CITRATE; IRON PENTACARBONYL; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; POTASSIUM IODIDE; ZINC OXIDE; CUPRIC OXIDE; DOCUSATE SODIUM 2700; 120; 200; 90; 400; 30; 3; 3.4; 20; 20; 1; 12; 150; 25; 2; 50 [iU]/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 63044-198_9f3bf415-c0c0-4a81-ad9b-7fffc9202832 63044-198 HUMAN OTC DRUG Iferex 150 Forte Iron, Cyanocobalamin and Folic Acid CAPSULE ORAL 20071028 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals IRON; CYANOCOBALAMIN; FOLIC ACID 150; 25; 1 mg/1; mg/1; mg/1 E 20171231 63044-203_53257303-5bbb-49f4-ba91-f3ea6c88a883 63044-203 HUMAN OTC DRUG IFEREX 150 Polysaccharide-Iron Complex CAPSULE ORAL 20071028 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals IRON 150 mg/1 E 20171231 63044-401_4c504dd6-9e4a-42c3-9fee-26d63c5c9e34 63044-401 HUMAN OTC DRUG Vitamin D3Dietary Supplemen Dietary Supplement CHOLECALCIFEROL CAPSULE, GELATIN COATED ORAL 20120114 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL .25; 5 mg/1; [iU]/1 E 20171231 63044-404_e730958b-9e8f-43b8-bcb2-ccddab3d9448 63044-404 HUMAN OTC DRUG Ammonium Lactate Ammonium Lactate CREAM TOPICAL 20071230 OTC MONOGRAPH NOT FINAL part334 Nnodum Pharmaceuticals AMMONIUM LACTATE 17 g/g E 20171231 63044-484_cba000ad-31e5-43a5-a992-8ae86298ad6d 63044-484 HUMAN OTC DRUG Ammonium Lactate Ammonium Lactate LOTION TOPICAL 20071230 OTC MONOGRAPH NOT FINAL part334 Nnodum Pharmaceuticals AMMONIUM LACTATE 17 g/g E 20171231 63044-622_71d7f6ee-3907-4214-8758-0f374526b6be 63044-622 HUMAN PRESCRIPTION DRUG RENO CAPS RENO CAPS CAPSULE ORAL 20081130 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals ASCORBIC ACID; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; BIOTIN; PANTOTHENIC ACID; CYANOCOBALAMIN 100; 1.5; 1.7; 20; 10; 1; 150; 5; 6 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 63044-631_7b22f471-94b6-42de-aa6f-35e441c00f57 63044-631 HUMAN PRESCRIPTION DRUG HEMATOGEN FERROUS FUMARATE, ASCORBIC ACID, INTRINSIC FACTOR , CYANOCOBALAMIN CAPSULE ORAL 20070510 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals FERROUS FUMARATE; ASCORBIC ACID; INTRINSIC FACTOR; CYANOCOBALAMIN 66; 250; 100; 10 mg/1; mg/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 63044-632_04d6e28a-1731-43fa-8d8a-192943c8e007 63044-632 HUMAN PRESCRIPTION DRUG Hematogen FA FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN CAPSULE ORAL 20050101 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals FERROUS FUMARATE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN 66; 250; 1; 10 mg/1; mg/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 63044-633_331ef233-b9e5-4539-b4f6-34b8084c34c4 63044-633 HUMAN PRESCRIPTION DRUG HEMATOGEN FORTE FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN CAPSULE, GELATIN COATED ORAL 20070510 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals FERROUS FUMARATE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN 151; 1; 10; 10 mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 63044-635_772d1dd3-a18c-4289-af06-ff0e144fab09 63044-635 HUMAN PRESCRIPTION DRUG TRICON TRICON CAPSULE ORAL 20050520 UNAPPROVED DRUG OTHER Nnodum Pharmaceuticals CYANOCOBALAMIN; FERROUS FUMARATE; ASCORBIC ACID; FOLIC ACID 15; 110; 75; .5 ug/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20181231 63045-001_81ac4b66-e47c-4a66-843f-d42d0b27803f 63045-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20060516 NDA NDA205827 Wyandotte Welding Supply Inc. OXYGEN 990 mL/L E 20171231 63047-0002_674b1461-3f04-486c-a143-8a8311d7f0e1 63047-0002 HUMAN OTC DRUG WHITE FLOWER ANALGESIC BALM Camphor, Menthol, Methyl Salicylate OIL TOPICAL 20100611 OTC MONOGRAPH NOT FINAL part348 MACAU-UNION PHARMACEUTICAL LTD CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 6; 14.5; 40.02 g/100mL; g/100mL; g/100mL E 20171231 63047-0011_b52dd2c0-b5c0-4eea-ac3b-0bef9a2241a3 63047-0011 HUMAN OTC DRUG WHITE FLOWER ANALGESIC BALM FLORAL SCENTED Camphor, Menthol, Methyl Salicylate OIL TOPICAL 20100730 OTC MONOGRAPH NOT FINAL part348 MACAU-UNION PHARMACEUTICAL LTD CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 5.4; 13; 35.8 g/100mL; g/100mL; g/100mL E 20171231 63047-0041_0acae80f-e6df-40fa-b88b-f7bfe282e457 63047-0041 HUMAN OTC DRUG WHITE FLOWER STRAIN RELIEF CAMPHOR, MENTHOL AND METHYL SALICYLATE OIL TOPICAL 20120307 OTC MONOGRAPH NOT FINAL part348 MACAU-UNION PHARMACEUTICAL LTD CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10.2; 15.3; 49.1 g/100mL; g/100mL; g/100mL E 20171231 63049-101_e8774106-4e4a-417c-8f57-43c8310bba0a 63049-101 HUMAN OTC DRUG EAD Avobenzone,Homosalate,Octisalate,Octocrylene LOTION TOPICAL 20140318 OTC MONOGRAPH NOT FINAL part352 European Perfume Works Co.L.L.C. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.44; 2.4; 6; 1.2 g/120mL; g/120mL; g/120mL; g/120mL N 20181231 63049-102_059bd67a-f42d-448f-90ac-23adcc83ebae 63049-102 HUMAN OTC DRUG EAD Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20140318 OTC MONOGRAPH NOT FINAL part352 European Perfume Works Co.L.L.C AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.4; 7.2; 6; 2.4; 2.4 g/120mL; g/120mL; g/120mL; g/120mL; g/120mL N 20181231 63049-103_bcc122f7-c1cb-47ed-98a7-4abb30f76f54 63049-103 HUMAN OTC DRUG EAD Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20140318 OTC MONOGRAPH NOT FINAL part352 European Perfume Works Co. L.L.C AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.4; 14.4; 6; 2.4; 2.4 g/120mL; g/120mL; g/120mL; g/120mL; g/120mL N 20181231 63049-105_5f4ab03b-6f72-4c60-a917-95257ef7e65f 63049-105 HUMAN OTC DRUG EAD Kids Avobenzone, Homosalate, Octocrylene, Octisalate, Oxybenzone LOTION TOPICAL 20141221 OTC MONOGRAPH NOT FINAL part352 European Perfume Works Co.L.L.C AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 2.64; 8.8; 4.4; 4.4; 4.4 g/88mL; g/88mL; g/88mL; g/88mL; g/88mL N 20181231 63054-0123_297624b2-c1db-47bf-bf2a-584e65577298 63054-0123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19950617 UNAPPROVED MEDICAL GAS Alert Respiratory Services, Inc. OXYGEN 99 L/100L E 20171231 63058-001_dfdec016-4cae-4a86-9eb3-511d3e0c5de7 63058-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Scott Valley Respiratory Home Care Inc. OXYGEN 99 L/100L E 20171231 63076-0001_553b5800-858a-4c05-a5f1-dc88870b7fdd 63076-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930703 UNAPPROVED MEDICAL GAS American Homecare Specialists, Inc. OXYGEN 99 L/100L E 20171231 63080-679_b32e2cc7-d93b-458f-9a30-189599d0b19e 63080-679 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19950101 UNAPPROVED MEDICAL GAS Galloping Hill Surgical Corp. dba Allcare Medical OXYGEN 99.8 L/100L E 20171231 63090-170_2b8b1eee-4c53-4eba-a8a5-e432eda06913 63090-170 HUMAN PRESCRIPTION DRUG NUPLAZID pimavanserin tartrate TABLET, COATED ORAL 20160429 NDA NDA207318 ACADIA Pharmaceuticals Inc PIMAVANSERIN TARTRATE 17 mg/1 Atypical Antipsychotic [EPC] N 20181231 63094-0426_11ddf219-8537-4a8f-b267-ef965159885e 63094-0426 HUMAN OTC DRUG TIOCONAZOLE Ointment 6.5% TIOCONAZOLE OINTMENT VAGINAL 20070822 ANDA ANDA075915 DPT Laboratories, Ltd. TIOCONAZOLE 65 mg/g E 20171231 63094-0801_3637ca89-694d-4061-a23d-e691093276e7 63094-0801 HUMAN OTC DRUG Scytera (coal tar) Foam, 2% coal tar foam, 2% AEROSOL, FOAM TOPICAL 20081031 OTC MONOGRAPH FINAL part358 DPT Laboratories, Ltd. COAL TAR 20 mg/g E 20171231 63102-101_a5fecf82-698c-453a-b67b-daa64e881531 63102-101 HUMAN OTC DRUG ACTINEL Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl SOLUTION ORAL 20140924 OTC MONOGRAPH FINAL part341 Actipharma, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 200; 30 mg/5mL; mg/5mL; mg/5mL N 20181231 63102-102_25fd8612-08ac-42a0-82d2-27c99ab0e792 63102-102 HUMAN OTC DRUG ACTINEL PEDIATRIC Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl SOLUTION ORAL 20140924 OTC MONOGRAPH FINAL part341 Actipharma, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 50; 15 mg/5mL; mg/5mL; mg/5mL N 20181231 63102-105_4d3eaf46-0891-4fe0-90c0-e730ad0c60e8 63102-105 HUMAN OTC DRUG ACTICON Dexbrompheniramine maleate, pseudoephedrine hydrochloride LIQUID ORAL 20160714 OTC MONOGRAPH FINAL part341 ACTIPHARMA, INC DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 30 mg/5mL; mg/5mL N 20181231 63102-106_9ca11e03-22bc-410f-b482-cfe0177b3d9e 63102-106 HUMAN OTC DRUG ACTISEP BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE SOLUTION TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part356 Actipharma, Inc BENZOCAINE; MENTHOL, UNSPECIFIED FORM; CETYLPYRIDINIUM CHLORIDE 2; .5; .1 g/100mL; g/100mL; g/100mL N 20181231 63102-107_6723d260-dd55-494f-a7f4-29c7f31983cc 63102-107 HUMAN OTC DRUG ACTISEP BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE SPRAY TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part356 Actipharma, Inc BENZOCAINE; MENTHOL, UNSPECIFIED FORM; CETYLPYRIDINIUM CHLORIDE 2; .5; .1 g/100mL; g/100mL; g/100mL N 20181231 63102-110_4616f3e7-7c68-422e-9fbb-a9be9fc99eb9 63102-110 HUMAN OTC DRUG ACTIDOM DMX DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE SOLUTION ORAL 20150813 OTC MONOGRAPH FINAL part341 Actipharma, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 30; 200; 10 mg/5mL; mg/5mL; mg/5mL N 20181231 63102-401_787c5d9b-1b93-4b55-83d4-cca03c5568e9 63102-401 HUMAN OTC DRUG ACTICON DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE TABLET ORAL 20150813 OTC MONOGRAPH FINAL part341 Actipharma, Inc DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 60 mg/1; mg/1 N 20181231 63102-402_d0f88f02-09df-4da8-b13c-377b67e9e03c 63102-402 HUMAN OTC DRUG ACTIDOGESIC Dexbrompheniramine maleate, acetaminophen TABLET ORAL 20161014 OTC MONOGRAPH FINAL part341 ACTIPHARMA, INC DEXBROMPHENIRAMINE MALEATE; ACETAMINOPHEN 1; 500 mg/1; mg/1 N 20181231 63104-001_2356095f-b006-411f-8de0-7d4c867368c2 63104-001 HUMAN OTC DRUG Bentasil SUGAR FREE BLACKCURRANT SOFT Texture Menthol LOZENGE ORAL 20140401 OTC MONOGRAPH FINAL part341 CLOETTA ITALIA S.r.l. MENTHOL 5 mg/1 E 20171231 63104-002_442be69f-b49e-4445-9bb7-20f91b9a8b3d 63104-002 HUMAN OTC DRUG Bentasil SUGAR FREE CHERRY SOFT Texture Menthol LOZENGE ORAL 20140401 OTC MONOGRAPH FINAL part341 CLOETTA ITALIA S.r.l. MENTHOL 5 mg/1 E 20171231 63104-003_5069cb14-68e1-4acc-8015-b3f12ad448ef 63104-003 HUMAN OTC DRUG Bentasil SUGAR FREE EUCALYPTUS SOFT Texture Menthol Eucalyptus LOZENGE ORAL 20140401 OTC MONOGRAPH FINAL part341 CLOETTA ITALIA S.r.l. MENTHOL; EUCALYPTUS OIL 5.8; 5.7 mg/1; mg/1 E 20171231 63104-004_bb51f005-43c0-49f4-9217-7c1011c442a4 63104-004 HUMAN OTC DRUG Bentasil SUGAR FREE HONEY LEMON SOFT Texture Menthol LOZENGE ORAL 20140401 OTC MONOGRAPH FINAL part341 CLOETTA ITALIA S.r.l. MENTHOL 5 mg/1 E 20171231 63121-123_3cc0f897-5eb2-4f8c-95bd-127c7c6021c6 63121-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960801 UNAPPROVED MEDICAL GAS First Community Care of Bassett OXYGEN 99 L/100L E 20171231 63127-100_1e776482-791a-40fb-820f-c0279aca232a 63127-100 HUMAN OTC DRUG La Defense Broad Spectrum SPF 30 Mineral Sunscreen Zinc Oxide LOTION TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part352 Luzern Laboratories, Inc ZINC OXIDE 15 g/100mL N 20191231 63127-200_7ba61e42-d575-4581-8696-e6fd686d03b2 63127-200 HUMAN OTC DRUG Skin-Perfecting Mineral Beauty Balm Broad Spectrum SPF 20 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140313 OTC MONOGRAPH NOT FINAL part352 Luzern Laboratories, Inc TITANIUM DIOXIDE; ZINC OXIDE 3; 7.5 g/100g; g/100g N 20191231 63127-300_47662860-16d0-4a47-9741-bdfbfe6e09cc 63127-300 HUMAN OTC DRUG La Defense Urban Protect Mineral Sunscreen Broad Spectrum SPF30 Zinc Oxide LOTION TOPICAL 20170920 OTC MONOGRAPH NOT FINAL part352 Luzern Laboratories, Inc. ZINC OXIDE 15 g/100g N 20191231 63127-400_d49acbca-c54e-422e-b9ab-c4db0de064e6 63127-400 HUMAN OTC DRUG La Defense Urban Protect Mineral BB Cream Broad Spectrum SPF20, Cool Undertone Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20170920 OTC MONOGRAPH NOT FINAL part352 Luzern Laboratories, Inc. TITANIUM DIOXIDE; ZINC OXIDE 3; 7.5 g/100g; g/100g N 20191231 63127-500_90cce23b-7105-4487-b68a-2b07d6678d2b 63127-500 HUMAN OTC DRUG La Defense Urban Protect Mineral BB Cream Broad Spectrum SPF20, Warm Undertone Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20170920 OTC MONOGRAPH NOT FINAL part352 Luzern Laboratories, Inc. TITANIUM DIOXIDE; ZINC OXIDE 3; 7.5 g/100g; g/100g N 20191231 63135-365_28c4b93a-1d1b-2340-e054-00144ff88e88 63135-365 HUMAN OTC DRUG NUMB ZONE LIDOCAINE 5% GEL TOPICAL 20150701 OTC MONOGRAPH FINAL part346 ESBA LABORATORIES INC. LIDOCAINE 5 g/100g E 20171231 63135-563_28d9a3e1-6b01-299a-e054-00144ff8d46c 63135-563 HUMAN OTC DRUG GENERAL NUMB LIDOCAINE 5% GEL TOPICAL 20150501 OTC MONOGRAPH FINAL part346 ESBA LABORATORIES INC. LIDOCAINE 5 g/100g E 20171231 63135-581_177994e8-1972-096f-e054-00144ff88e88 63135-581 HUMAN OTC DRUG TOPICAINE 5 LIDOCAINE 5% GEL TOPICAL 20030420 OTC MONOGRAPH FINAL part346 ESBA LABORATORIES INC. LIDOCAINE 5 g/100g E 20171231 63138-120_63b16db9-fcfb-4d2b-a9c4-cf3dae88b14b 63138-120 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960926 UNAPPROVED MEDICAL GAS Parkmor Drug Inc. OXYGEN 99 L/100L E 20171231 63146-101_01be293b-5b28-45c4-bf4b-4d30a1e6e1c5 63146-101 HUMAN OTC DRUG Conquest Chloroxylenol SOLUTION TOPICAL 20051013 OTC MONOGRAPH NOT FINAL part333E KAY CHEMICAL CO. CHLOROXYLENOL .5 mL/100mL N 20181231 63146-102_fbfeb47b-002d-411b-962d-2e9e4fabd44e 63146-102 HUMAN OTC DRUG McD Anti-Microbial Handwash (AMH) Chloroxylenol SOLUTION TOPICAL 20051013 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company CHLOROXYLENOL .5 mL/100mL N 20181231 63146-103_a7bfd919-bcf7-4956-9ad0-9919e5145bf4 63146-103 HUMAN OTC DRUG DermaFoam E Antibacterial Hand Soap Antiseptic handwash SOLUTION TOPICAL 20051013 OTC MONOGRAPH NOT FINAL part333 Kay Chemical CHLOROXYLENOL 1 mL/100mL N 20181231 63146-104_02fa58e7-d5a4-469b-a04e-a83731bf8016 63146-104 HUMAN OTC DRUG Marquis chloroxylenol SOLUTION TOPICAL 20051113 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co. CHLOROXYLENOL .5 mL/100mL N 20181231 63146-105_f1dceb32-dddf-4f21-8751-aed1d1cf400f 63146-105 HUMAN OTC DRUG Fortress Chloroxylenol SOLUTION TOPICAL 20050516 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co. CHLOROXYLENOL 5 mg/mL N 20181231 63146-108_9a807a16-e8f1-46cb-8202-3f0ecd5a28b7 63146-108 HUMAN OTC DRUG McD Chloroxylenol SOAP TOPICAL 20070817 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co. CHLOROXYLENOL .5 mg/100mL N 20181231 63146-109_aab96bf7-db2c-403e-b864-9dd371217fb6 63146-109 HUMAN OTC DRUG Kay Benzalkonium Chloride SOLUTION TOPICAL 20080222 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 63146-110_14099b56-4d13-4342-bf30-1ed323f281c2 63146-110 HUMAN OTC DRUG QSR Chloroxylenol SOLUTION TOPICAL 20091215 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company CHLOROXYLENOL 5 mg/mL N 20181231 63146-111_249339b2-a57b-4f53-b2df-571e09fbbbb8 63146-111 HUMAN OTC DRUG QSR Chloroxyenol SOLUTION TOPICAL 20100222 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company CHLOROXYLENOL 5 mg/mL N 20181231 63146-112_fb93e04d-0444-4e68-81ad-2f138a3759cf 63146-112 HUMAN OTC DRUG QSR Hand Sanitizer Alcohol SOLUTION TOPICAL 20100223 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company ALCOHOL 534 mg/mL N 20181231 63146-116_e98649f6-928f-40d4-b118-69a2cc171e1f 63146-116 HUMAN OTC DRUG Mystic Triclosan SOLUTION TOPICAL 20101122 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company TRICLOSAN .3 mL/100mL N 20181231 63146-117_9c63940d-5bc0-489a-8399-45822a9f02b2 63146-117 HUMAN OTC DRUG Mystic Foaming Hand Sanitizer Benzalkonium chloride SOLUTION TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 63146-118_5243e6c2-506c-4f1c-b5cd-4446fa7db0bb 63146-118 HUMAN OTC DRUG Kay QSR Triclosan SOLUTION TOPICAL 20110830 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co. TRICLOSAN .3 mL/100mL N 20181231 63146-121_f9ce7efb-5304-4eeb-9b59-ed64dedc820f 63146-121 HUMAN OTC DRUG Lagarde Chloroxylenol SOLUTION TOPICAL 20160531 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co. CHLOROXYLENOL .5 mg/100mL N 20181231 63146-122_ea772fad-366e-4820-975e-bcac5c166509 63146-122 HUMAN OTC DRUG Ecolab Benzalkonium chloride SOLUTION TOPICAL 20160218 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company BENZALKONIUM CHLORIDE 19.8 mg/mL N 20181231 63146-123_5e8a0ca0-b8a2-40b0-adfd-45848359b0c7 63146-123 HUMAN OTC DRUG Ecolab Benzalkonium Chloride SOLUTION TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 63146-124_b79a35cc-2c10-4619-a9eb-09a3ffbda146 63146-124 HUMAN OTC DRUG Ecolab Chloroxylenol SOLUTION TOPICAL 20151230 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company CHLOROXYLENOL 5 mg/mL N 20181231 63146-201_62539921-c022-40aa-9756-983b84a1e915 63146-201 HUMAN OTC DRUG Conquest II chloroxylenol SOLUTION TOPICAL 20051013 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co CHLOROXYLENOL .5 mL/100mL N 20181231 63146-301_6b82b899-44dc-4cd9-9c5b-a4a0ea7ba2f1 63146-301 HUMAN OTC DRUG Actigel Hand Sanitizer Alcohol SOLUTION TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company ALCOHOL 534 mg/mL N 20181231 63146-302_edc26609-6078-4e47-8c80-52e73baea651 63146-302 HUMAN OTC DRUG McD Hand Sanitizer Ethanol, 60% by volume SOLUTION TOPICAL 20100526 OTC MONOGRAPH NOT FINAL part333 Kay Chemical Company ETHANOL 60 mL/100mL N 20181231 63146-303_15cf5b4b-f0c4-44eb-a56a-76ff7a224519 63146-303 HUMAN OTC DRUG Kay Alphasan Hand Sanitizer Alcohol SOLUTION TOPICAL 20051013 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Co ALCOHOL 60 mL/100mL N 20181231 63146-304_5f2f7f8d-2db6-4e1b-a679-f97eb28582e8 63146-304 HUMAN OTC DRUG Mystic Benzalkonium Chloride SOLUTION TOPICAL 20160211 OTC MONOGRAPH NOT FINAL part333E Kay Chemical Company BENZALKONIUM CHLORIDE 5 mg/mL N 20181231 63148-079_5fdb87e0-a1d6-4538-a6e4-ed88e55733b8 63148-079 HUMAN OTC DRUG MEMBERS SELECTION ANTIBACTERIAL BENZALKONIUM CHLORIDE LIQUID TOPICAL 20150708 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 63148-079_f0fdb7f1-9565-4dbe-abad-bb38702f2c86 63148-079 HUMAN OTC DRUG MEMBERS SELECTION ANTIBACTERIAL BENZALKONIUM CHLORIDE LIQUID TOPICAL 20150809 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 63148-080_93a90dc5-bc98-48e5-9506-9d63733e7cb9 63148-080 HUMAN OTC DRUG MEMBERS SELECTION ALOE VERA SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20150708 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE ALCOHOL 700 mg/mL N 20181231 63148-101_1103fab0-78b7-47d6-beaa-c8816e8a425a 63148-101 HUMAN OTC DRUG Giant Eagle Golden Amber Benzalkonium chloride LIQUID TOPICAL 20161027 OTC MONOGRAPH NOT FINAL part333E Apoll Health and Beauty Care BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-102_a66d960e-93bb-487f-9604-1f2facc93686 63148-102 HUMAN OTC DRUG Giant Eagle White Tea Foaming Refill Benzalkonium Chloride LIQUID TOPICAL 20170516 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-102_f0ba03d3-dc1f-4e31-89c4-c77dafacf03c 63148-102 HUMAN OTC DRUG Giant Eagle White Tea Foaming Refill Benzalkonium chloride LIQUID TOPICAL 20161027 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-103_a87ca218-361f-48d3-87de-79749e242850 63148-103 HUMAN OTC DRUG AURORA ANTIBACTERIAL JAPANESE FLOWER GARDEN TRICLOSAN LIQUID TOPICAL 20150113 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE TRICLOSAN 4.6 mg/mL N 20181231 63148-104_cdf8f314-db1e-4273-87c7-f5030a01d734 63148-104 HUMAN OTC DRUG AURORA ANTIBACTERIAL COCONUT TROPICAL ISLAND TRICLOSAN LIQUID TOPICAL 20150113 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE TRICLOSAN 4.6 mg/mL N 20181231 63148-105_eb0ccb12-abbe-4881-8543-a2e6ad8524d4 63148-105 HUMAN OTC DRUG AURORA ANTIBACTERIAL APPLE SUMMER BERRY TRICLOSAN LIQUID TOPICAL 20150113 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE TRICLOSAN 4.6 mg/mL N 20181231 63148-106_84448a89-3149-4a54-bd06-5a060d48ef79 63148-106 HUMAN OTC DRUG AURORA ANTIBACTERIAL BASIL KEY LIME TRICLOSAN LIQUID TOPICAL 20150113 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE TRICLOSAN 4.6 mg/mL N 20181231 63148-107_9a1a78ec-d482-4a2a-b1fa-2500cf1ace64 63148-107 HUMAN OTC DRUG AURORA ANTIBACTERIAL VANILLA BROWN SUGAR TRICLOSAN LIQUID TOPICAL 20150114 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE TRICLOSAN 3 mg/mL N 20181231 63148-108_172c27f7-e0e8-4a4b-a4be-0025063c1792 63148-108 HUMAN OTC DRUG Giant Eagle Red Berry Foaming Benzalkonium Chloride LIQUID TOPICAL 20161103 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-108_1d00f26d-867a-4181-97f6-1244943fdd62 63148-108 HUMAN OTC DRUG Giant Eagle Red Berry Foaming Benzalkonium Chloride LIQUID TOPICAL 20170509 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-109_8e5a7d68-d72d-4f48-87a8-89b7662990e4 63148-109 HUMAN OTC DRUG Crisp Clean Antibacterial Hand Benzalkonium Chloride SOAP TOPICAL 20170329 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-110_5b6ba44a-3f6f-447f-b940-db202aa068fd 63148-110 HUMAN OTC DRUG Fresh Water Antibacterial Foaming Hand Benzalkonium Chloride SOAP TOPICAL 20170329 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-112_86ab573e-1674-41f3-8ec8-c97a98f12da2 63148-112 HUMAN OTC DRUG Crisp Pear Antibacterial Foaming Hand Benzalkonium Chloride SOAP TOPICAL 20170329 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-118_d3e90fc2-15ab-4d26-b51f-58eaa9a5faa7 63148-118 HUMAN OTC DRUG PRICE CHOPPER PUMPKIN SPICE ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20140605 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE TRICLOSAN 4.6 mg/mL N 20181231 63148-140_8d28c156-5e49-4d3f-959c-e6e8640da049 63148-140 HUMAN OTC DRUG ANTIBACTERIAL HAND SOAP WITH LIGHT MOISTURIZERS TRICLOSAN LOTION TOPICAL 20100224 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE TRICLOSAN .115 mL/100mL N 20181231 63148-141_00009b19-6d96-435d-8dc2-13432b12ee9e 63148-141 HUMAN OTC DRUG ANTIBACTERIAL HAND SOAP WITH LIGHT MOISTURIZERS TRICLOSAN LOTION TOPICAL 20100224 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE TRICLOSAN .115 mL/100mL N 20181231 63148-164_981ecab8-cd2c-4d72-90e0-d9d8bf60c819 63148-164 HUMAN OTC DRUG ANTIBACTERIAL FOAMING POMEGRANATE TRICLOSAN LIQUID TOPICAL 20100706 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care TRICLOSAN .46 mL/100mL N 20181231 63148-165_bf09bb77-1853-4b0e-a3d2-c4f0162f1b32 63148-165 HUMAN OTC DRUG CARE ONE Antibacterial Foaming Hand Soap Green Tea Triclosan LIQUID TOPICAL 20090717 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care TRICLOSAN .46 mL/100mL N 20181231 63148-167_c2ac7051-2f25-414a-a367-54fe55ce541f 63148-167 HUMAN OTC DRUG Foaming Antibacterial Cucumber Melon Triclosan LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care TRICLOSAN .6 mL/100mL N 20181231 63148-173_f865e380-74bc-4e4f-a4a0-c1d749796b87 63148-173 HUMAN OTC DRUG FOAMING ANTIBACTERIAL PLUMERIA TRICLOSAN SOAP TOPICAL 20100720 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE TRICLOSAN .6 mL/100mL N 20181231 63148-197_21d5146c-28a7-46fe-8a31-c8e129d418ec 63148-197 HUMAN OTC DRUG P.O.V. Antibacterial Foaming Hand Benzalkonium Chloride SOAP TOPICAL 20171110 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-198_46d138e0-d108-4190-8e42-0c4a01a8b5c5 63148-198 HUMAN OTC DRUG P.O.V. Springtime Renewal Antibacterial Foaming Hand Benzalkonium Chloride SOAP TOPICAL 20171110 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-199_1c23c86a-a0cc-484f-8c41-46501660491f 63148-199 HUMAN OTC DRUG P.O.V. Light Moisturizing Antibacterial Hand Benzalkonium Chloride SOAP TOPICAL 20171110 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-215_0d880a28-6433-43cf-81d9-12f12ca88be1 63148-215 HUMAN OTC DRUG Antibacterial Mandarin and Grapefruit Handsoap Gentle Cleansing Formula TRICLOSAN LIQUID TOPICAL 20100628 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care TRICLOSAN .15 mL/100mL N 20181231 63148-225_7fee5284-8e16-4511-8e94-daf556137e7f 63148-225 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100705 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL N 20181231 63148-225_8c1aea5c-a193-4abc-a50b-4fda78d92818 63148-225 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20100220 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL N 20181231 63148-240_b035432f-f0d7-42d5-b132-2e4fb2674032 63148-240 HUMAN OTC DRUG FOAMING HAND SANITIZER WITH ALOE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100625 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 63148-241_54677fac-cf5e-4cdd-a77c-5780a69ba972 63148-241 HUMAN OTC DRUG ANTIMICROBIAL FOAMING FALLING RAIN BENZETHONIUM CHLORIDE LIQUID TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE BENZETHONIUM CHLORIDE .1 mL/100mL N 20181231 63148-250_00a86e8f-dc4e-4125-bf56-bd361c424899 63148-250 HUMAN OTC DRUG CVS PHARMACY INSTANT HAND SANITIZER FRESH SCENT ETHYL ALCOHOL GEL TOPICAL 20091010 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care ALCOHOL 62 mL/100mL N 20181231 63148-251_3ff94d36-7237-448f-bb7b-5d8d4a39b013 63148-251 HUMAN OTC DRUG CVS PHARMACY ANTI-AGING HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20091020 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care ALCOHOL 62 mL/100mL N 20181231 63148-252_51834035-0a13-4d92-a608-43b7d23a44b3 63148-252 HUMAN OTC DRUG CVS Pharmacy FOAM HAND SANITIZER WITH ALOE ETHYL ALCOHOL LIQUID TOPICAL 20091217 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care ALCOHOL 70 mL/100mL N 20181231 63148-253_677a3bd4-f63f-467b-9de2-e08900b8e987 63148-253 HUMAN OTC DRUG CVS PHARMACY INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20091010 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care ALCOHOL 65 mL/100mL N 20181231 63148-258_4cfcba2a-a6bc-4e1b-a546-3c7853f15f21 63148-258 HUMAN OTC DRUG HAND SANITIZER CITRUS COCONUT with moisture beads ETHYL ALCOHOL GEL TOPICAL 20100215 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL N 20181231 63148-259_7882c344-2b45-46de-af0e-f828f29b6ac2 63148-259 HUMAN OTC DRUG HAND SANITIZER PASSION FLOWER with moisture beads ETHYL ALCOHOL GEL TOPICAL 20100215 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL N 20181231 63148-261_a524f129-150a-483c-8e18-00ea1aca338b 63148-261 HUMAN OTC DRUG HAND SANITIZER SUN BLOSSOM with moisture beads ETHYL ALCOHOL GEL TOPICAL 20100215 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL N 20181231 63148-262_540a79ad-8727-4721-8045-5f900054702b 63148-262 HUMAN OTC DRUG HAND SANITIZER POMEGRANATE APPLE with moisture beads ETHYL ALCOHOL GEL TOPICAL 20100215 OTC MONOGRAPH NOT FINAL part333 APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL N 20181231 63148-269_3df5a074-1fdc-4b7a-af72-35b7bcd7f131 63148-269 HUMAN OTC DRUG ANTIBACTERIAL HAND SANITIZER BASIL AND GREEN TEA ETHYL ALCOHOL GEL TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL N 20181231 63148-270_50f99008-5d7c-4bbb-a500-223b23363e81 63148-270 HUMAN OTC DRUG ANTIBACTERIAL HAND SANITIZER SUNFLOWER AND CITRUS ETHYL ALCOHOL GEL TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL N 20181231 63148-271_4280f663-da2f-4cbb-91bb-7b29718d61e7 63148-271 HUMAN OTC DRUG ANTIBACTERIAL HAND SANITIZER POMEGRANATE AND ACAI ETHYL ALCOHOL GEL TOPICAL 20110415 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE ALCOHOL 62 mL/100mL N 20181231 63148-273_5a9083d9-67ae-496a-8b10-c3c3357bcc07 63148-273 HUMAN OTC DRUG Giant Eagle White Tea Foaming Benzalkonium chloride LIQUID TOPICAL 20161103 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-273_c52e9c36-5a1b-440a-b7ac-5e6e2a69964a 63148-273 HUMAN OTC DRUG Giant Eagle White Tea Foaming Benzalkonium Chloride LIQUID TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-319_f8cc4e42-599c-41bd-8c05-7f98d3ceffc0 63148-319 HUMAN OTC DRUG P.O.V. Baby Moisturizing Fragrance Free Dimethicone LOTION TOPICAL 20171124 OTC MONOGRAPH FINAL part347 Apollo Health and Beauty Care Inc. DIMETHICONE 12 mg/mL N 20181231 63148-320_ee252b4a-8893-40eb-98c2-5050a432cdd9 63148-320 HUMAN OTC DRUG SKIN MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL DIMETHICONE LOTION TOPICAL 20100625 OTC MONOGRAPH FINAL part347 APOLLO HEALTH AND BEAUTY CARE DIMETHICONE 1.25 mL/100mL N 20181231 63148-330_5ff46716-6084-416e-9026-e4cc90a879ae 63148-330 HUMAN OTC DRUG HYDRATING HEALING DAILY THRAPY PETROLATUM OINTMENT TOPICAL 20100719 OTC MONOGRAPH FINAL part347 APOLLO HEALTH AND BEAUTY CARE PETROLATUM 41 g/100g N 20181231 63148-407_fa57f178-c758-4b4b-8c94-47d0a8ebc52e 63148-407 HUMAN OTC DRUG AURORA ANTIBACTERIAL SANITIZER SWEET LYCHEE BERRY ETHYL ALCOHOL LIQUID TOPICAL 20150112 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE ALCOHOL 650 mg/mL N 20181231 63148-408_d918b33f-b4de-4bc2-b62c-bfe7c89cabe9 63148-408 HUMAN OTC DRUG AURORA ANTIBACTERIAL SANITIZER SUMMER COTTON BREEZE ETHYL ALCOHOL LIQUID TOPICAL 20150113 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE ALCOHOL 650 mg/mL N 20181231 63148-410_c540c83b-fcc8-49d6-ace5-c83de4e7d4d1 63148-410 HUMAN OTC DRUG P.O.V. 2 in 1 Dry Scalp Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20171120 OTC MONOGRAPH FINAL part358H Apollo Health and Beauty Care Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 63148-411_6f7b6bc2-078e-4b6a-a70a-b6b648eec8f8 63148-411 HUMAN OTC DRUG P.O.V. Classic Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20171120 OTC MONOGRAPH FINAL part358H Apollo Health and Beauty Care Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 63148-411_d646c4b7-7c48-4af7-8068-61c3c55b0496 63148-411 HUMAN OTC DRUG P.O.V. Classic Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20171226 OTC MONOGRAPH FINAL part358H Apollo Health and Beauty Care Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 63148-413_da65f662-fa4d-4fd4-b82c-6050d512bb53 63148-413 HUMAN OTC DRUG Classic Control Antidandruff Pyrithione Zinc SHAMPOO TOPICAL 20170329 OTC MONOGRAPH FINAL part358H Apollo Health and Beauty Care Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 63148-415_1304e99e-3db8-4b9b-980e-7edf78946615 63148-415 HUMAN OTC DRUG 2 in 1 Antidandruff Pyrithione Zinc SHAMPOO TOPICAL 20170329 OTC MONOGRAPH FINAL part358H Apollo Health and Beauty Care Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 63148-416_8486bf4c-e409-42b5-a78d-cabdcd5e8a67 63148-416 HUMAN OTC DRUG P.O.V. Dry Scalp Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20171120 OTC MONOGRAPH FINAL part358H Apollo Health and Beauty Care Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 63148-418_b94730e1-3d0f-4bea-a4ba-a8c290bb5695 63148-418 HUMAN OTC DRUG DANDRUFF SHAMPOO AND CONDITIONER WITH CUCUMBER AND LEMONGRASS EXTRACTS PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20100308 OTC MONOGRAPH FINAL part358 APOLLO HEALTH AND BEAUTY CARE PYRITHIONE ZINC 1 mL/100mL N 20181231 63148-422_88c771f3-12c7-4877-8ed8-f4961bb10252 63148-422 HUMAN OTC DRUG ANTI-DANDRUFF SHAMPOO AND CONDITIONER HOWL PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20100308 OTC MONOGRAPH FINAL part358 Apollo Health and Beauty Care PYRITHIONE ZINC 1 mL/100mL N 20181231 63148-431_be1da441-edb8-4bae-8671-9deaa3acbbdf 63148-431 HUMAN OTC DRUG P.O.V. Green Apple 2 in 1 Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20171120 OTC MONOGRAPH FINAL part358H Apollo Health and Beauty Care Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 63148-433_a8b50460-08cb-4e34-aedb-bb5bb6195341 63148-433 HUMAN OTC DRUG P.O.V. Timeless Spice 2 in 1 Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20171124 OTC MONOGRAPH FINAL part358H Apollo Health and Beauty Care Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 63148-434_802c36dc-84e3-4789-b2cd-9b0f6e30d72a 63148-434 HUMAN OTC DRUG Alberto VO5 2 in 1 Dandruff Pyrithione Zinc LIQUID TOPICAL 20160118 OTC MONOGRAPH FINAL part358H APOLLO HEALTH AND BEAUTY CARE PYRITHIONE ZINC 10 mg/mL N 20181231 63148-441_b05b5c58-3561-48fc-8e54-d93ad3b3c572 63148-441 HUMAN OTC DRUG P.O.V. Classic 2 in 1 Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20171124 OTC MONOGRAPH FINAL part358H Apollo Health and Beauty Care Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 63148-450_f396572c-fab5-4b35-8ad1-25f009d8c436 63148-450 HUMAN OTC DRUG NUTRIXYL ANTI-DANDRUFF SALICYLIC ACID LIQUID TOPICAL 20140918 OTC MONOGRAPH FINAL part358H APOLLO HEALTH AND BEAUTY CARE SALICYLIC ACID 20 mg/mL N 20181231 63148-479_15df077c-a401-44a5-ab36-fa2549e426e7 63148-479 HUMAN OTC DRUG HDX Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20170120 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Inc. ALCOHOL 700 mg/mL N 20181231 63148-479_6b0d60f7-f798-43a3-959e-03f184918ca8 63148-479 HUMAN OTC DRUG HDX Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20170504 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. ALCOHOL 700 mg/mL N 20181231 63148-479_8a83e36a-2186-4518-b0ea-7c67c1c96800 63148-479 HUMAN OTC DRUG HDX Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20160818 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care ALCOHOL 700 mg/mL N 20181231 63148-506_000dc679-44c3-4bd1-98a7-be869cd8a16c 63148-506 HUMAN OTC DRUG P.O.V. Vitamin E Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20171110 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. ALCOHOL 650 mg/mL N 20181231 63148-507_903c04bb-72bc-453e-9a43-e9ae04eb3da4 63148-507 HUMAN OTC DRUG P.O.V. Aloe Vera Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20171110 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. ALCOHOL 650 mg/mL N 20181231 63148-553_256504f1-abbb-4e05-9886-e3c06eea6af1 63148-553 HUMAN OTC DRUG Aurora Alcohol Free Clean Mint Cetylpyridinium Chloride MOUTHWASH BUCCAL 20160614 OTC MONOGRAPH NOT FINAL part356 Apollo Health and Beauty Care CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 63148-556_178eb802-d15c-4886-9113-b83e55176dc0 63148-556 HUMAN OTC DRUG MARCS ORIGINAL EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140213 OTC MONOGRAPH NOT FINAL part356 APOLLO HEALTH AND BEAUTY CARE EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63148-557_cab8004b-b0eb-4d57-adcc-b3edf5fae46c 63148-557 HUMAN OTC DRUG MARCS BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140213 OTC MONOGRAPH NOT FINAL part356 APOLLO HEALTH AND BEAUTY CARE EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63148-558_350b0901-4a78-46fb-a11c-a11321773616 63148-558 HUMAN OTC DRUG MARCS SPRING MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20140213 OTC MONOGRAPH NOT FINAL part356 APOLLO HEALTH AND BEAUTY CARE EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63148-559_59b49882-5a84-49c4-9ab6-aa7a83a45c9d 63148-559 HUMAN OTC DRUG Aurora Blue Mint Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH BUCCAL 20160613 OTC MONOGRAPH NOT FINAL part356 Apollo Health and Beauty Care EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63148-560_8fd01b90-7898-451b-a3f7-aa6c8c85e476 63148-560 HUMAN OTC DRUG Aurora Fresh Burst Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH BUCCAL 20160613 OTC MONOGRAPH NOT FINAL part356 Apollo Health and Beauty Care EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63148-724_36b09fad-680a-49c4-9a4e-d835a6f6bad6 63148-724 HUMAN OTC DRUG Giant Eagle Refreshing Citrus Refill Benzalkonium Chloride LIQUID TOPICAL 20161027 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-724_fa7951b2-99fa-4116-8a2f-397794586850 63148-724 HUMAN OTC DRUG Giant Eagle Refreshing Citrus Refill Benzalkonium Chloride LIQUID TOPICAL 20161027 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-801_c0f5a6ac-3714-4da1-9610-5cb77832b473 63148-801 HUMAN OTC DRUG Natural Concept Body Wash Spring Breeze Triclosan SOAP TOPICAL 20100922 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care TRICLOSAN .15 mL/100mL N 20181231 63148-804_22066d6b-8e5c-4a38-a5a5-4ce84ef7a9fb 63148-804 HUMAN OTC DRUG SPARKLING MIST ANTIBACTERIAL CLEANSER WITH MOISTURIZERS TRICLOSAN LOTION TOPICAL 20100715 OTC MONOGRAPH NOT FINAL part333 Apollo Health and Beauty Care TRICLOSAN .15 mL/100mL N 20181231 63148-807_47867315-24b5-4647-996f-b6d8d2759d37 63148-807 HUMAN OTC DRUG AURORA BODY WASH CRISP WATERS BENZALKONIUM CHLORIDE LIQUID TOPICAL 20150303 OTC MONOGRAPH NOT FINAL part333E APOLLO HEALTH AND BEAUTY CARE BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-842_59e7e502-1fd8-4997-a640-a52e4315cf3a 63148-842 HUMAN OTC DRUG Giant Eagle Coconut Water Foaming Benalkonium Chloride LIQUID TOPICAL 20161103 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63148-842_ffd9ef69-ec59-4313-8218-b453b5aa7c7e 63148-842 HUMAN OTC DRUG Giant Eagle Coconut Water Foaming Benalkonium Chloride LIQUID TOPICAL 20170523 OTC MONOGRAPH NOT FINAL part333E Apollo Health and Beauty Care Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63162-508_34f2008d-8ed5-4ef7-8c03-c8fd56d77d93 63162-508 HUMAN OTC DRUG Balamine DM Syrup Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide LIQUID ORAL 20130423 OTC MONOGRAPH FINAL part341 Ballay Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 2; 5; 10 mg/5mL; mg/5mL; mg/5mL E 20171231 63162-510_8742a375-a463-41bf-b9d7-1fc303dcd62f 63162-510 HUMAN OTC DRUG Childrens Nortemp Acetaminophen SOLUTION ORAL 20140326 OTC MONOGRAPH NOT FINAL part343 Ballay Pharmaceuticals, Inc ACETAMINOPHEN 160 mg/5mL E 20171231 63162-520_da947d56-e0f5-4f91-88bd-82990cd4a7c4 63162-520 HUMAN OTC DRUG Balahist DM Syrup Brompheniramine Maleate, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide LIQUID ORAL 20140106 OTC MONOGRAPH FINAL part341 Ballay Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 4; 7.5; 15 mg/5mL; mg/5mL; mg/5mL E 20171231 63174-172_0f34f883-7781-46ff-aa86-842bf5cf1837 63174-172 HUMAN OTC DRUG Morning Fresh Sodium Monofluorophosphate PASTE ORAL 20130405 OTC MONOGRAPH FINAL part355 Choice Laboratories Limited SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 63174-211_0e835741-1f5d-4418-b9fb-974baaef54c0 63174-211 HUMAN OTC DRUG Petrolatum Petrolatum JELLY TOPICAL 20150518 OTC MONOGRAPH FINAL part347 Choice Laboratories Limited PETROLATUM 1 g/g E 20171231 63174-214_792dae09-40ca-41e8-acf5-f4898b94738a 63174-214 HUMAN OTC DRUG Choice Vitamin A D Petrolatum OINTMENT TOPICAL 20130719 OTC MONOGRAPH FINAL part347 Choice Laboratories Limited PETROLATUM .76 g/g E 20171231 63174-224_d268b744-00fa-42e1-9275-ee17990c70f6 63174-224 HUMAN OTC DRUG Hydrocortisone Hydrocortisone Acetate CREAM TOPICAL 20100202 OTC MONOGRAPH FINAL part348 Choice Laboratories HYDROCORTISONE ACETATE 1 g/100g E 20171231 63181-0010_1217d971-3111-46cc-a693-3a80bb531991 63181-0010 HUMAN OTC DRUG REPASKIN FACIAL, BROAD SPECTRUM SPF 30 OCTOCRYLENE, PHENYLBENZIMIDAZOLE SULFONIC ACID CREAM TOPICAL 20140404 OTC MONOGRAPH NOT FINAL part352 Sesvalia USA LLC OCTOCRYLENE; ENSULIZOLE 50; 20 mg/mL; mg/mL N 20181231 63181-0011_aeba5ccb-fcb7-4c8a-a84f-ce5597754d3f 63181-0011 HUMAN OTC DRUG REPASKIN FACIAL, BROAD SPECTRUM SPF 50 OCTOCRYLENE, TITANIUM DIOXIDE CREAM TOPICAL 20140404 OTC MONOGRAPH NOT FINAL part352 Sesvalia USA LLC OCTOCRYLENE; TITANIUM DIOXIDE 70; 20 mg/mL; mg/mL N 20181231 63181-0012_b14d0e46-6884-42ab-92fe-a3b0dd16014f 63181-0012 HUMAN OTC DRUG REPASKIN BODY LOTION, BROAD SPECTRUM SPF 30 OCTOCRYLENE, PHENYLBENZIMIDAZOLE SULFONIC ACID CREAM TOPICAL 20140404 OTC MONOGRAPH NOT FINAL part352 Sesvalia USA LLC OCTOCRYLENE; ENSULIZOLE 50; 20 mg/mL; mg/mL N 20181231 63181-0013_f66727c6-163c-4dac-9157-c3181f852b45 63181-0013 HUMAN OTC DRUG REPASKIN BODY LOTION, BROAD SPECTRUM SPF 50 OCTOCRYLENE, TITANIUM DIOXIDE CREAM TOPICAL 20140404 OTC MONOGRAPH NOT FINAL part352 Sesvalia USA LLC OCTOCRYLENE; TITANIUM DIOXIDE 70; 20 mg/mL; mg/mL N 20181231 63181-0014_c3a22d4f-eafa-4411-812d-85fa016a273d 63181-0014 HUMAN OTC DRUG Sesderma SESPREVEX Calming and protecting foam ZINC OXIDE AEROSOL, FOAM TOPICAL 20140407 OTC MONOGRAPH FINAL part347 Sesvalia USA LLC ZINC OXIDE 140 mg/mL N 20181231 63181-0015_a4a11e27-e109-4d6b-85a4-a3ebcca6e62e 63181-0015 HUMAN OTC DRUG Dryses Antiperspirant Solution ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20140402 OTC MONOGRAPH FINAL part350 SESVALIA USA LLC. ALUMINUM CHLOROHYDRATE 200 mg/mL N 20181231 63181-0016_352dee35-c03d-4fa7-b113-4a1f7ea89dd5 63181-0016 HUMAN OTC DRUG SALISES FACIAL Moisturizing acne treatment gel SALICYLIC ACID GEL TOPICAL 20140404 OTC MONOGRAPH FINAL part333D Sesvalia USA LLC SALICYLIC ACID 15 mg/mL N 20181231 63181-0017_23e315ae-a937-46bf-87bc-d0d212529399 63181-0017 HUMAN OTC DRUG SCREENSES Tinted facial make-up cream zinc oxide and octinoxate sunscreen CREAM TOPICAL 20140407 OTC MONOGRAPH FINAL part352 Sesvalia USA LLC ZINC OXIDE; OCTINOXATE 90; 75 mg/mL; mg/mL N 20181231 63181-0018_d43e8896-4e6f-4391-98a5-1053e50d3eb5 63181-0018 HUMAN OTC DRUG LIDOCARE MIST Lidocaine SPRAY TOPICAL 20140404 OTC MONOGRAPH NOT FINAL part348 Sesvalia USA LLC LIDOCAINE 20 mg/mL E 20171231 63181-0019_5d9a60a4-f6c4-4d1e-b8b3-6f74faabd39e 63181-0019 HUMAN OTC DRUG Dryses Deoderant for men, Roll-on ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20140407 OTC MONOGRAPH FINAL part350 SESVALIA USA LLC. ALUMINUM CHLOROHYDRATE 180 mg/mL N 20181231 63187-001_4f1d911f-0daf-4975-bfa8-a4c31d8b4ca6 63187-001 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20040809 ANDA ANDA076673 Proficient Rx LP CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 63187-002_026c4323-519e-469c-997a-d1eab539a4b3 63187-002 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA078050 Proficient Rx LP ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-003_110b351c-fd13-408a-bf08-e47c1fcd8c93 63187-003 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Proficient Rx LEVOFLOXACIN 500 mg/1 E 20171231 63187-004_110b351c-fd13-408a-bf08-e47c1fcd8c93 63187-004 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Proficient Rx LEVOFLOXACIN 750 mg/1 E 20171231 63187-005_940c4ba6-80f4-4c9c-831d-1d166ef9a3fe 63187-005 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20080131 NDA NDA020987 Proficient Rx PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 63187-006_69c094f4-1ffe-4d36-8143-34f4bed175c6 63187-006 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20040214 ANDA ANDA075694 Proficient Rx GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63187-007_a6c8c7c3-2449-44f2-9f3b-597cb5c3a2cb 63187-007 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 Proficient Rx LP AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 63187-008_19403f70-443a-473b-a7ce-d93514c09629 63187-008 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20060822 ANDA ANDA076817 Proficient Rx LP SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 63187-009_c2353d09-3cb4-486e-8ae7-29339c1ba76b 63187-009 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Proficient Rx LP TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 63187-010_ae03f7ae-4a89-4b50-afa8-a3afc5d1f7ac 63187-010 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Proficient Rx LP GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63187-011_e454a0d1-b556-4829-8dd1-f3e81eb897cf 63187-011 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19890503 ANDA ANDA071611 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-012_af8fb06a-2c52-482d-80e3-1b5a4577b954 63187-012 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Proficient Rx LP DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-013_b0eb1422-7498-4738-b605-ff419a45e6f1 63187-013 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 Proficient Rx LP AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-014_1e91c5ce-3482-47ca-92e7-e492196992d9 63187-014 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091568 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 63187-015_2777e4f2-2b8d-41f5-a96a-02dec8c7c3e0 63187-015 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20110608 ANDA ANDA090480 Proficient Rx LP MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 63187-016_ca5093d6-0a2c-4757-b179-0939560ac8e1 63187-016 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Proficient Rx LP BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 63187-017_9730c220-e087-4540-8c39-b67307fe2de1 63187-017 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Proficient Rx LP CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63187-018_5b9c497c-5e32-4c77-82ab-fe6abdd9cf57 63187-018 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073517 Proficient Rx LP KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63187-019_c8aa97bc-268f-4b29-8f34-8963e5eb509a 63187-019 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Proficient Rx LP METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-020_7c650dc8-43f6-4257-81ed-c93b00202d06 63187-020 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Proficient Rx LP PREDNISONE 5 mg/1 E 20171231 63187-021_a37ccef8-18e8-4194-9618-1b5657ade6ca 63187-021 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20080116 ANDA ANDA077570 Proficient Rx LP FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63187-022_3ae84988-2aa8-4452-9335-d79a9c5b9737 63187-022 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Proficient Rx LP IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-023_5e7e3225-3a08-436a-a51f-511cef9f0870 63187-023 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 Proficient Rx LP SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 63187-024_d8235017-cb52-44d4-a6e6-6ee3f00c47d2 63187-024 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19931129 ANDA ANDA064052 Proficient Rx LP TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 63187-025_2c8228b5-0e40-442f-8ed6-b08bcc857ba1 63187-025 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Proficient Rx LP TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63187-026_7203f00e-421a-4598-9f55-5d520239fa23 63187-026 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 Proficient Rx LP ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 63187-027_b0eb1422-7498-4738-b605-ff419a45e6f1 63187-027 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin POWDER, FOR SUSPENSION ORAL 19990415 NDA NDA050760 Proficient Rx LP AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-028_779900d1-263f-4fe4-9458-4de3e536ca1d 63187-028 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Proficient Rx LP NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-029_832d74a7-6cc4-479c-84df-a5b05db0131d 63187-029 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Proficient Rx LP AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 63187-030_cdcd804e-f35c-4b06-85c3-e9f5e747974f 63187-030 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION ORAL 20060524 ANDA ANDA077893 Proficient Rx LP POLYETHYLENE GLYCOL 3350 17 g/1 Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] E 20171231 63187-031_29582f4d-be1f-4024-9905-5afd26b55a91 63187-031 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Proficient Rx LP GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63187-032_6ff04525-4f64-40d3-a45d-23cf8afb9cbf 63187-032 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 63187-033_f81eff3b-8386-45a6-9d00-a58634e31ffa 63187-033 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19840626 ANDA ANDA019117 Proficient Rx LP FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63187-034_664d2b50-b88d-4727-ba57-a05dfcff0fce 63187-034 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Proficient Rx LP HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 63187-035_e51f7a62-9d4e-412d-b392-e2e2053eadb4 63187-035 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 Proficient Rx LP METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 63187-036_407f9cad-8976-4d84-8570-37857d1c65c6 63187-036 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Proficient Rx LP MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 63187-037_c128993f-5766-4bfb-b920-413f8fcd23e4 63187-037 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Proficient Rx LP PREDNISONE 10 mg/1 N 20181231 63187-038_a8b2a622-8cc1-4a22-a15f-4ed713d92790 63187-038 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 Proficient Rx LP PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63187-039_0eccfd19-1cf6-4f57-af1f-5efa282770b1 63187-039 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL part333B Proficient Rx LP BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 63187-040_a3eff326-b2c6-4e2a-a424-912511433467 63187-040 HUMAN OTC DRUG Q Tussin DM Dextromethorphan HBr and Guaifenesin SYRUP ORAL 19950401 OTC MONOGRAPH FINAL part341 Proficient Rx LP DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 63187-041_c5cd2b99-7c38-4cd8-ba54-8bc12f939061 63187-041 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960308 ANDA ANDA020254 Proficient Rx LP DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63187-042_610175a3-05c4-4c8e-9166-9b8776f07a6b 63187-042 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110208 ANDA ANDA090797 Proficient Rx LP PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 63187-043_61bd8983-9890-463c-be87-aa42af9778c9 63187-043 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19880225 ANDA ANDA062884 Proficient Rx LP AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 63187-044_441463fe-e42c-4b44-9fc6-88993169d18f 63187-044 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 Proficient Rx LP AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 63187-045_1a2203e9-09ae-4b74-9df7-4ac51446035b 63187-045 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 Proficient Rx LP PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 63187-046_b6c9c301-0150-4ff9-9af2-7ce436ec44a2 63187-046 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 Proficient Rx LP CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63187-047_f0cbbe23-701b-474c-8bea-0e4503cf354c 63187-047 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Proficient Rx LP LEVOFLOXACIN 500 mg/1 E 20171231 63187-048_f0cbbe23-701b-474c-8bea-0e4503cf354c 63187-048 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Proficient Rx LP LEVOFLOXACIN 750 mg/1 E 20171231 63187-049_68daf82a-334e-43ca-b4bb-5c66a82f52c8 63187-049 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Proficient Rx LP SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 63187-050_af0b3bef-be36-432a-884e-ea81e2d5c08e 63187-050 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Proficient Rx LP LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63187-051_af0b3bef-be36-432a-884e-ea81e2d5c08e 63187-051 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 Proficient Rx LP LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63187-052_072dc45b-15b8-4a89-8c7b-44aae9364e23 63187-052 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Proficient Rx LP BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63187-053_73346bc7-dcb8-452f-9c8f-5e6a83c09096 63187-053 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Proficient Rx LP TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63187-054_7e6ff7b1-bd5c-475c-a6af-eac7f10fd2ea 63187-054 HUMAN PRESCRIPTION DRUG MonoNessa norgestimate and ethinyl estradiol KIT 20030101 NDA NDA019653 Proficient Rx LP E 20171231 63187-055_e084d4be-d68e-419f-91ac-8b57305cf4c2 63187-055 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Proficient Rx LP SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-056_29582f4d-be1f-4024-9905-5afd26b55a91 63187-056 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Proficient Rx LP GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63187-057_ae03f7ae-4a89-4b50-afa8-a3afc5d1f7ac 63187-057 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Proficient Rx LP GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63187-058_78f85824-6033-481a-9635-cd0e776a58d4 63187-058 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL; SUBLINGUAL 20090921 UNAPPROVED DRUG OTHER Proficient Rx LP HYOSCYAMINE SULFATE .125 mg/1 N 20181231 63187-059_a78326bc-3745-4d1f-9428-f4a4fb6b7656 63187-059 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Proficient Rx LP TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 63187-060_a78326bc-3745-4d1f-9428-f4a4fb6b7656 63187-060 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Proficient Rx LP TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 63187-061_815bc342-a0b9-43cd-9311-870e7389d755 63187-061 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Proficient Rx LP OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-062_818ed01a-5b75-4a75-a971-c4cdefa8dfa9 63187-062 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120314 NDA NDA022370 Proficient Rx LP TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 63187-063_a3f31bf6-455b-4e6f-8ee4-79421c2cb5c0 63187-063 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Proficient Rx LP TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 63187-064_15aa57c4-c881-485a-9318-9fdaaff2e12e 63187-064 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20100723 ANDA ANDA091004 Proficient Rx LP ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] E 20171231 63187-065_4beba8a0-6533-4404-860d-b3c3ad18c1cf 63187-065 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Proficient Rx LP ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-066_c128993f-5766-4bfb-b920-413f8fcd23e4 63187-066 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Proficient Rx LP PREDNISONE 5 mg/1 N 20181231 63187-067_4c5c0ed8-fe43-4693-83f3-25b6c16b74c6 63187-067 HUMAN OTC DRUG MEDI-SULTING TOPICAL PAIN RELIEF METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE PATCH TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE 20; 5; .035; .5 g/100g; g/100g; g/100g; g/100g E 20171231 63187-069_892abaf3-4c83-423f-8c07-fd27f7d562a2 63187-069 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Proficient Rx LP FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-070_815bc342-a0b9-43cd-9311-870e7389d755 63187-070 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Proficient Rx LP OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-071_c843ff50-6a8d-4223-be71-0588dd3f5e55 63187-071 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Proficient Rx LP LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-072_c843ff50-6a8d-4223-be71-0588dd3f5e55 63187-072 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Proficient Rx LP LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-073_e1f930f0-a446-4c74-a6e2-1eb16c9c44bc 63187-073 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 Proficient Rx LP RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63187-074_c51e3178-cdae-42f1-be03-e184563c57aa 63187-074 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 Proficient Rx LP HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63187-075_27d6b334-9921-4a6c-8d0d-01682e0265fc 63187-075 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Proficient Rx LP SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-076_d998b638-5066-4c3c-afe7-a571025fc283 63187-076 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Proficient Rx LP BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 63187-077_a78326bc-3745-4d1f-9428-f4a4fb6b7656 63187-077 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Proficient Rx LP TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 63187-078_56e88a96-5be0-4a5c-995e-77c807c5294b 63187-078 HUMAN OTC DRUG Theragesic Creme METHYL SALICYLATE GEL TOPICAL 19810101 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP METHYL SALICYLATE; MENTHOL 150; 10 mg/g; mg/g E 20171231 63187-079_9f9dd7b9-a072-46d0-a8b5-b3e138c85f1c 63187-079 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 19981002 NDA NDA020998 Proficient Rx LP CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63187-080_c7a36fd8-530e-4c63-97d5-0f80fab5880e 63187-080 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA090568 Proficient Rx LP ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 63187-081_892abaf3-4c83-423f-8c07-fd27f7d562a2 63187-081 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Proficient Rx LP FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-082_e861d945-bc58-4b5a-86c3-98a1bbe4527c 63187-082 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Proficient Rx LP MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-083_e861d945-bc58-4b5a-86c3-98a1bbe4527c 63187-083 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Proficient Rx LP MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-084_070e2547-8feb-4978-b149-55db5b680ef1 63187-084 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Proficient Rx LP TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 63187-085_d0124c1b-3eb2-41bd-b0ea-d1a6b1f0ea8e 63187-085 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 Proficient Rx LP PREDNISONE 20 mg/1 N 20181231 63187-086_8f1a6915-cb2a-4bdc-a15f-ee6e9161bbbf 63187-086 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Proficient Rx LP TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63187-087_c8aa97bc-268f-4b29-8f34-8963e5eb509a 63187-087 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Proficient Rx LP METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-088_a93ed941-dcfd-4944-8e5a-3289a29f54f0 63187-088 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073555 Proficient Rx LP NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63187-089_477d6cdc-6466-4d95-a2ae-42fc73c159ed 63187-089 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Proficient Rx LP FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63187-090_1258cb39-6cfe-4cad-853a-509de5618838 63187-090 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Proficient Rx LP LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-091_d5e45418-aa9f-44ab-b200-6e04473872a5 63187-091 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Proficient Rx LP RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63187-092_f4cf6cd9-a329-4c1f-aa39-700ae9812347 63187-092 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Proficient Rx LP ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 63187-093_6a44901f-a112-435e-aca2-251b71edeecd 63187-093 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101217 ANDA ANDA065246 Proficient Rx LP AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 63187-094_679e418b-13ef-44d5-ab7a-9972fa2f6958 63187-094 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20120314 ANDA ANDA078048 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 63187-095_46d99e40-835d-4e36-b9a0-3e0b26f0519b 63187-095 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20070103 ANDA ANDA076002 Proficient Rx LP CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-096_5cdb81b0-fbf6-4992-832c-5343ed006e3b 63187-096 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Proficient Rx LP FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 63187-097_97fdbf93-8afc-4bcb-9252-0cc6911ba95f 63187-097 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Proficient Rx LP FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 63187-098_a9c51398-ceb8-4517-a866-d84f48b2f35b 63187-098 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Proficient Rx LP LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-099_74aeb6ec-01b0-4fbb-a4c4-4441eb92a2b3 63187-099 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Proficient Rx LP LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63187-100_50a983f2-dd46-4fe6-8903-6b1875acea95 63187-100 HUMAN OTC DRUG Loratadine Allergy Relief Loratadine TABLET ORAL 20030828 ANDA ANDA076134 Proficient Rx LP LORATADINE 10 mg/1 N 20181231 63187-101_901dfe34-f708-46b8-abfc-b08d1383f908 63187-101 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Proficient Rx LP METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63187-102_901dfe34-f708-46b8-abfc-b08d1383f908 63187-102 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Proficient Rx LP METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63187-103_3f0dfd25-25e4-461c-ae6c-569253fc895c 63187-103 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Proficient Rx LP METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-104_d265f12d-8237-429a-b7f0-736dc147f0fb 63187-104 HUMAN OTC DRUG good sense all day pain relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Proficient Rx LP NAPROXEN SODIUM 220 mg/1 E 20171231 63187-105_8b451673-3b4b-4f3a-bdf8-72ac0b253a44 63187-105 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Proficient Rx LP PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-106_04fd835c-c080-4e12-8a00-eff3c6593927 63187-106 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Proficient Rx LP ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 63187-107_3590f862-1148-4e8e-ad8a-aa8abc8945af 63187-107 HUMAN OTC DRUG Flexall Pain Relieving Menthol GEL TOPICAL 19970101 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP MENTHOL .16 g/g E 20171231 63187-108_44f0df8b-6069-4941-87e9-2c57c8dfddfa 63187-108 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Proficient Rx LP ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-109_44f0df8b-6069-4941-87e9-2c57c8dfddfa 63187-109 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Proficient Rx LP ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-110_d14feb90-3ca2-4d5b-825c-25fc2252ca38 63187-110 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Proficient Rx LP CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 63187-111_ec21f5ff-a658-4931-955e-e8c25b06749e 63187-111 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Proficient Rx LP TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 63187-112_1b05232a-5375-4560-b92d-4c63cbe19d79 63187-112 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 Proficient Rx LP HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 63187-113_499b650a-2def-461f-bf9f-3c7314c27aeb 63187-113 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20140601 ANDA ANDA040755 Proficient Rx LP CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-114_25e71199-c55d-4cc6-8388-b309d654d2b0 63187-114 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Proficient Rx LP ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 63187-115_df3dbec4-b2a8-42f1-b736-5de4e3e8d751 63187-115 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Proficient Rx LP ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 63187-116_df3dbec4-b2a8-42f1-b736-5de4e3e8d751 63187-116 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Proficient Rx LP ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 63187-117_49e75518-f02b-4251-8239-c71c3376cadc 63187-117 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 Proficient Rx LP GUAIFENESIN; CODEINE PHOSPHATE 100; 10 mg/5mL; mg/5mL CV E 20171231 63187-118_bef9fc73-b19d-4b4f-8950-79af8cc178d6 63187-118 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Proficient Rx LP TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-119_2684d7af-ac0a-48e5-8d11-36a0421a3099 63187-119 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071219 ANDA ANDA077056 Proficient Rx LP PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 63187-120_fd4d6729-9233-4d6f-b568-bbb0e1c40377 63187-120 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040746 Proficient Rx LP HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 63187-121_da9b993d-3eb5-4b11-a292-62e378d70fb2 63187-121 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Proficient Rx LP NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63187-122_cf620257-7497-44c1-9853-87f96d262fbd 63187-122 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Proficient Rx LP ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 63187-123_d88c45a4-7478-497d-93e1-15629181f650 63187-123 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 63187-124_1dc26259-cd2a-4dbf-acfa-08fe3554aa74 63187-124 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140127 ANDA ANDA077284 Proficient Rx LP BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 63187-125_9ff570c5-1d0e-47bb-aea2-347c7b24ca68 63187-125 HUMAN OTC DRUG Promolaxin Docusate sodium TABLET ORAL 20110415 OTC MONOGRAPH NOT FINAL part334 Proficient Rx LP DOCUSATE SODIUM 100 mg/1 E 20171231 63187-127_d6e1a5f2-9dcb-49fb-a5b0-d7d543520ac3 63187-127 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 Proficient Rx LP CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 63187-128_b0cadb2f-05d2-4869-9910-3e2f39bd8cf1 63187-128 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 Proficient Rx LP KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 63187-129_c84b0ba3-1ba8-4da9-b5b8-186e01cda999 63187-129 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Proficient Rx LP FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63187-130_b8d49bdf-720c-4dc9-be26-0c7d32d4ba11 63187-130 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130115 ANDA ANDA086988 Proficient Rx LP METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-131_c03bd9d7-1e0b-49da-a14a-32e712dc3a2d 63187-131 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Proficient Rx LP CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 63187-132_904b8986-24da-48eb-bb0a-33d41b4eb005 63187-132 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 Proficient Rx LP TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63187-133_8f1a6915-cb2a-4bdc-a15f-ee6e9161bbbf 63187-133 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 Proficient Rx LP TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63187-135_9e935b91-7500-4bf6-a032-f75bddd306e2 63187-135 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20001201 ANDA ANDA065055 Proficient Rx LP DOXYCYCLINE 100 mg/1 E 20171231 63187-136_7e765fc1-74c6-4af3-a9cf-05b57011d7d8 63187-136 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP METHYL SALICYLATE; MENTHOL; CAPSAICIN 18; 6; .015 g/60mL; g/60mL; g/60mL E 20171231 63187-137_a769150d-d2b3-4ec8-be4d-42a57b2f4210 63187-137 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Proficient Rx LP HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 63187-138_07e8c29f-cc38-4a9c-b4cf-3e210d64bd1e 63187-138 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 Proficient Rx LP AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 63187-139_d09771da-9958-40ea-b5c0-005685d88cbb 63187-139 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110127 ANDA ANDA075661 Proficient Rx LP IBUPROFEN 200 mg/1 E 20171231 63187-140_580222de-7fbb-424a-970d-aba15be6eb22 63187-140 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Proficient Rx LP CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-141_b3052f67-5f99-40ed-9811-9d293c06bf28 63187-141 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Proficient Rx LP CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63187-142_9730c220-e087-4540-8c39-b67307fe2de1 63187-142 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Proficient Rx LP CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63187-143_f173ff13-7417-415b-8725-3c2f2dd3e5b5 63187-143 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Proficient Rx LP AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63187-144_355f5170-b129-4ac9-be61-ea70b04c4ee5 63187-144 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20130812 ANDA ANDA040526 Proficient Rx LP PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 63187-145_1a9adcd5-e09e-4baa-bf06-1d9da075af56 63187-145 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Proficient Rx LP TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 63187-146_8eed846e-9826-485d-8a18-578cb8f6a0cf 63187-146 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110101 ANDA ANDA077836 Proficient Rx LP GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 63187-147_58b923d2-507d-40aa-be53-b71b7f2b7f21 63187-147 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072234 Proficient Rx LP BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 63187-148_c79d94ec-117d-4fb6-845d-1954e3472bb0 63187-148 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 Proficient Rx LP GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63187-149_4f68a6e5-71b7-4a19-b933-681b001e25b9 63187-149 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20121029 ANDA ANDA202764 Proficient Rx LP GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63187-150_4e2a2c8b-2a56-4b14-ab8c-ca914d0b191a 63187-150 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20080320 ANDA ANDA077689 Proficient Rx LP CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 63187-151_d8766748-6b53-4673-a3ee-5cd8a4301647 63187-151 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20050923 ANDA ANDA065170 Proficient Rx LP MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 63187-152_7d811f01-f0c2-4753-bb36-80b48dabb58c 63187-152 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 ANDA ANDA077255 Proficient Rx LP LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 63187-153_a93ed941-dcfd-4944-8e5a-3289a29f54f0 63187-153 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073555 Proficient Rx LP NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63187-154_0d088c7f-d806-49da-a34a-46d86e6ca173 63187-154 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970423 ANDA ANDA074578 Proficient Rx LP ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 63187-155_9faf560b-6022-42c3-8389-9a0e109a39c1 63187-155 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Proficient Rx LP AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63187-156_da7c5db6-a950-401c-90ed-c2ca433b2bb3 63187-156 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Proficient Rx LP AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63187-157_0d62109f-d518-482f-8a75-051c3f999a19 63187-157 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 63187-158_a21e2a54-1216-43ef-8d1a-d521dfd22858 63187-158 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium rabeprazole TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA076885 Proficient Rx LP RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 63187-159_d5e45418-aa9f-44ab-b200-6e04473872a5 63187-159 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Proficient Rx LP RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63187-160_283a913e-f737-478e-b6a0-e050fb6562d8 63187-160 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 Proficient Rx LP METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-161_7f7eedea-0723-4e8f-a250-4c786aeb95e8 63187-161 HUMAN OTC DRUG LenzaGel LIDOCAINE HYDROCHLORIDE, MENTHOL GEL TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g N 20181231 63187-162_a4ba3e83-ca7c-4ff2-824c-77fe08e1586c 63187-162 HUMAN OTC DRUG LenzaPatch LIDOCAINE HYDROCHLORIDE, MENTHOL LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g E 20171231 63187-163_3ab508ed-4b12-4dd7-a13e-1a071f560286 63187-163 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 19980105 ANDA ANDA062452 Proficient Rx LP GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 63187-164_5cba3661-9b16-416b-b0c0-bbb12549d48f 63187-164 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20090813 ANDA ANDA076554 Proficient Rx LP SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 63187-166_5e800ed9-c0c4-42d7-904a-4b4937aa4e45 63187-166 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Proficient Rx LP IBUPROFEN 100 mg/5mL E 20171231 63187-167_b98dbda3-a5b5-4a2c-a4a3-e6f6adf199a2 63187-167 HUMAN OTC DRUG Good Sense Allergy Relief diphenhydramine hydrochloride CAPSULE ORAL 19890915 OTC MONOGRAPH FINAL part341 Proficient Rx LP DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 63187-168_b650e8b6-6df7-4301-837d-3d3b650b7456 63187-168 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 Proficient Rx LP ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 63187-169_bd5e0df4-cef0-4d6b-bd42-fb2da8e4b36b 63187-169 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Proficient Rx LP AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 63187-170_7f176b51-23f6-4567-bc61-e8671bc79cfa 63187-170 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA076048 Proficient Rx LP OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-172_35ec3eb6-aa04-4375-acb6-ac708200d912 63187-172 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Proficient Rx LP DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63187-173_9c4a168d-e4f5-426b-bbde-b53d8ab4a4d2 63187-173 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071321 Proficient Rx LP DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-174_3f0dfd25-25e4-461c-ae6c-569253fc895c 63187-174 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Proficient Rx LP METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-175_2c7ee4be-3fe1-4b45-b56e-56bc85e2bf6a 63187-175 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 Proficient Rx LP ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 63187-176_072dc45b-15b8-4a89-8c7b-44aae9364e23 63187-176 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Proficient Rx LP BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63187-177_74b86a6e-100c-4317-aadf-bad311424565 63187-177 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Proficient Rx LP VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-178_072dc45b-15b8-4a89-8c7b-44aae9364e23 63187-178 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Proficient Rx LP BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63187-180_eb47a42a-5cc1-4117-8d6a-8fcda2ebfb10 63187-180 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 Proficient Rx LP ESZOPICLONE 1 mg/1 CIV E 20171231 63187-181_35ec3eb6-aa04-4375-acb6-ac708200d912 63187-181 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Proficient Rx LP DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63187-182_b2c19660-4f9e-48e2-9918-5954962c45ab 63187-182 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20091022 ANDA ANDA075090 Proficient Rx LP ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63187-184_14e6e355-3a87-43dc-80a2-070b9df93bf1 63187-184 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20040514 ANDA ANDA076527 Proficient Rx LP OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63187-185_ca5093d6-0a2c-4757-b179-0939560ac8e1 63187-185 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Proficient Rx LP BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 63187-186_de792ac6-4b3d-4d34-8e50-030b5bd830d7 63187-186 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 Proficient Rx LP AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 63187-187_cd054ea1-2bfa-4814-bd88-618c4b8f04b5 63187-187 HUMAN OTC DRUG Ear Wax Remover CARBAMIDE PEROXIDE LIQUID AURICULAR (OTIC) 20090527 OTC MONOGRAPH FINAL part344 Proficient Rx LP CARBAMIDE PEROXIDE 65 mg/mL N 20181231 63187-188_32d09bd1-f31d-4f39-9600-f80b4eff02f1 63187-188 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110301 ANDA ANDA075693 Proficient Rx LP IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 63187-189_a6c8c7c3-2449-44f2-9f3b-597cb5c3a2cb 63187-189 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 Proficient Rx LP AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 63187-190_8b451673-3b4b-4f3a-bdf8-72ac0b253a44 63187-190 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Proficient Rx LP PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-191_27d6b334-9921-4a6c-8d0d-01682e0265fc 63187-191 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Proficient Rx LP SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-192_c36864bc-7c26-46bf-934d-ea658cfe1b18 63187-192 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20060313 ANDA ANDA077309 Proficient Rx LP ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63187-193_2c5579eb-ad81-415e-8dcb-9f1c94c897ae 63187-193 HUMAN PRESCRIPTION DRUG Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate SOLUTION OPHTHALMIC 19981217 ANDA ANDA065006 Proficient Rx LP TRIMETHOPRIM SULFATE; POLYMYXIN B SULFATE 1; 10000 mg/mL; [USP'U]/mL Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 63187-194_6bc8768d-81f5-4d3a-ba30-ea78726c3d09 63187-194 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Proficient Rx LP LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-195_832d74a7-6cc4-479c-84df-a5b05db0131d 63187-195 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Proficient Rx LP AMOXICILLIN 600 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 63187-196_646eca5c-aa3c-455f-8c41-164066477996 63187-196 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 Proficient Rx LP DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 63187-197_61837ac5-0a0b-4ea9-b71c-d4c753294ed6 63187-197 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Proficient Rx LP AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63187-198_61837ac5-0a0b-4ea9-b71c-d4c753294ed6 63187-198 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Proficient Rx LP AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63187-199_09d20c6e-ed54-405f-b4ea-2df395222ff3 63187-199 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Proficient Rx LP ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-200_d9ce2002-d13f-43f2-8d2e-a3e9c92bd1cc 63187-200 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 Proficient Rx LP AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-201_f351339a-38d9-4298-99a9-e01f25d0e567 63187-201 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073025 Proficient Rx LP ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-202_33fe365c-361b-4a5f-b7d5-c6033a0cf584 63187-202 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 Proficient Rx LP CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63187-203_c38d2677-a3d9-41e4-9395-8652312984ff 63187-203 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Proficient Rx LP CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-204_d3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b 63187-204 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 Proficient Rx LP ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 63187-205_9d09f0a8-b70e-4649-998d-e86ba48fca69 63187-205 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 Proficient Rx LP CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 63187-206_9b1dfb56-f84b-4669-a472-598a91cd1d6d 63187-206 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Proficient Rx LP MIRTAZAPINE 15 mg/1 N 20181231 63187-207_ae831d2e-df29-4856-9a16-480f6974cbd5 63187-207 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030129 ANDA ANDA076119 Proficient Rx LP MIRTAZAPINE 30 mg/1 N 20181231 63187-208_ddf052a3-23a5-4d8c-a684-e8d464f1ab03 63187-208 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061227 ANDA ANDA077657 Proficient Rx LP LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63187-209_b4c63849-8423-4029-a21e-fa09ff2db48d 63187-209 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Proficient Rx LP RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-210_b4c63849-8423-4029-a21e-fa09ff2db48d 63187-210 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Proficient Rx LP RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-211_b4c63849-8423-4029-a21e-fa09ff2db48d 63187-211 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Proficient Rx LP RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-212_e084d4be-d68e-419f-91ac-8b57305cf4c2 63187-212 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Proficient Rx LP SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-213_bf813b4e-1964-40ac-853e-d4a701506ff3 63187-213 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine TABLET ORAL 20110101 ANDA ANDA077533 Proficient Rx LP TERBINAFINE HYDROCHLORIDE 250 1/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 63187-214_73346bc7-dcb8-452f-9c8f-5e6a83c09096 63187-214 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 19780309 ANDA ANDA085692 Proficient Rx LP TRIAMCINOLONE ACETONIDE .025 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63187-215_807cd867-637b-4961-9595-04a659f8f66f 63187-215 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20050425 ANDA ANDA076913 Proficient Rx LP PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-216_06b8d913-95d5-4a42-a542-bc9ede2e9a0d 63187-216 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA201522 Proficient Rx LP MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 63187-217_991f2fe9-6943-4e2c-b901-1d8e10b6db10 63187-217 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Proficient Rx LP ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-218_d7144d7f-9d54-4fb0-a78e-c99a2e09987b 63187-218 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride TABLET, FILM COATED ORAL 20020130 ANDA ANDA075872 Proficient Rx LP FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63187-219_ba089fe8-23a6-42e3-a31d-69e88782b5f5 63187-219 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Proficient Rx LP QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-220_c38d2677-a3d9-41e4-9395-8652312984ff 63187-220 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Proficient Rx LP CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-221_0eb5a80f-bac0-4e8a-bf3d-5426a2a6aa1f 63187-221 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Proficient Rx LP BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 63187-222_1ed633f3-1937-4e3f-9485-f85a4e9de229 63187-222 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Proficient Rx LP DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-223_ea0f0a8f-c9a3-4acb-8d8f-2adcbaa0779c 63187-223 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 ANDA ANDA020699 Proficient Rx LP VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-224_ea0f0a8f-c9a3-4acb-8d8f-2adcbaa0779c 63187-224 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110610 ANDA ANDA020699 Proficient Rx LP VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-225_9f749fad-e3d8-490b-9ca7-5915bd55131c 63187-225 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Proficient Rx LP ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-226_3db76496-27c7-49c4-bcfd-2616e4d33d50 63187-226 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960918 ANDA ANDA074569 Proficient Rx LP CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-227_a93ed941-dcfd-4944-8e5a-3289a29f54f0 63187-227 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073555 Proficient Rx LP NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63187-228_4a601b38-37e7-44e7-9e91-e2979ffef16d 63187-228 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Proficient Rx LP TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 63187-229_9faf560b-6022-42c3-8389-9a0e109a39c1 63187-229 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Proficient Rx LP AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63187-231_71d84c83-b58b-44b6-a6fc-851f4f3b6c29 63187-231 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20121029 ANDA ANDA202764 Proficient Rx LP GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63187-232_32945c14-3cd9-44e1-a9e3-b9e5f4513a6e 63187-232 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Proficient Rx LP DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 63187-233_1a2a5194-b793-4c62-a177-040dad38526b 63187-233 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Proficient Rx LP FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63187-234_72c6d6cb-a82d-4a45-a7f9-fad60a271fa4 63187-234 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Proficient Rx LP GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 63187-235_af650f42-a90a-4ed4-898c-f9a2a0000df2 63187-235 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Proficient Rx LP METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 63187-236_4beba8a0-6533-4404-860d-b3c3ad18c1cf 63187-236 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Proficient Rx LP ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-237_a9c51398-ceb8-4517-a866-d84f48b2f35b 63187-237 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Proficient Rx LP LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-238_1b9b6db9-1bac-4252-a03c-18dc0271f05f 63187-238 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Proficient Rx LP METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 63187-239_1b9b6db9-1bac-4252-a03c-18dc0271f05f 63187-239 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Proficient Rx LP METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 63187-240_0ca4baed-c5d8-4de4-ac17-6e5d1df15c03 63187-240 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018877 Proficient Rx LP ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 63187-241_6b6ad6c8-22f8-456b-bc54-a02fb6cbea8c 63187-241 HUMAN PRESCRIPTION DRUG valsartan and hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA203026 Proficient Rx LP VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63187-243_720c758c-4f25-41d3-8152-ced5f983feb1 63187-243 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030314 ANDA ANDA084283 Proficient Rx LP PREDNISONE 50 mg/1 N 20181231 63187-244_a21cdb0e-69ee-4d2f-a45c-1693b7bca238 63187-244 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20050527 ANDA ANDA040574 Proficient Rx LP HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 63187-245_cc49358c-273d-4616-9602-22a87e059d64 63187-245 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Proficient Rx LP NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 63187-247_b3052f67-5f99-40ed-9811-9d293c06bf28 63187-247 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Proficient Rx LP CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63187-248_29582f4d-be1f-4024-9905-5afd26b55a91 63187-248 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Proficient Rx LP GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63187-249_1a528236-6375-4630-b4e1-8db250a4cbef 63187-249 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20110715 ANDA ANDA090618 Proficient Rx LP NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 63187-250_3aa816f9-9a5a-4418-8af6-f948cd75c989 63187-250 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Proficient Rx LP CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63187-251_3e2fa56c-0239-4cc8-a2f9-958a9203b58d 63187-251 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 19980301 ANDA ANDA040268 Proficient Rx LP PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63187-252_2d7577b7-3fff-44e4-b840-200a14a8856a 63187-252 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Proficient Rx LP METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-253_9cdbd789-384a-4907-b46b-918db2698e15 63187-253 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 Proficient Rx LP ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63187-254_116cdf8f-af62-4811-a6fb-a3c0a5089706 63187-254 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 Proficient Rx LP DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 63187-255_3ff57f0d-4967-4fe1-bb54-5de5165cc592 63187-255 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110301 ANDA ANDA074550 Proficient Rx LP GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 63187-256_09d20c6e-ed54-405f-b4ea-2df395222ff3 63187-256 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Proficient Rx LP ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-257_a9c51398-ceb8-4517-a866-d84f48b2f35b 63187-257 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Proficient Rx LP LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-258_23c000e0-cc29-414c-906d-1ccd91c24d54 63187-258 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 Proficient Rx LP MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 63187-259_255e9a78-d600-48df-80ff-8d18bdac5dd9 63187-259 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA090678 Proficient Rx LP RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 63187-260_9faf560b-6022-42c3-8389-9a0e109a39c1 63187-260 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Proficient Rx LP AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63187-261_3529953d-0fba-4a15-996d-6f0af1b1e91a 63187-261 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20091030 ANDA ANDA065123 Proficient Rx LP MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 63187-262_e0d6f4f2-b074-4c40-b949-dd17f3b1beb1 63187-262 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Proficient Rx LP AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-263_8241a57e-f9bd-4007-9544-c6b2a076e405 63187-263 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Proficient Rx LP NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 63187-264_088dc3dd-7740-471b-8c06-5a47900ae5b5 63187-264 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140423 ANDA ANDA201003 Proficient Rx LP RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 63187-265_e9ea2f77-11c3-4dbf-bdc4-d1b0e7437990 63187-265 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20100511 ANDA ANDA090121 Proficient Rx LP FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 63187-266_496a8756-a58a-4a0a-acdb-9d1724b6765b 63187-266 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Proficient Rx LP ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-267_62896bec-669e-4f20-a1e4-4f99afd35d32 63187-267 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 Proficient Rx LP ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 63187-268_c8020ad4-ac74-4ceb-863e-94da605cf23f 63187-268 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20040514 ANDA ANDA076622 Proficient Rx LP OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 63187-269_ba089fe8-23a6-42e3-a31d-69e88782b5f5 63187-269 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Proficient Rx LP QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-270_09b5550e-78ed-465b-a90c-7c19c689a44a 63187-270 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 Proficient Rx LP NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-271_53e98254-eef0-4422-9891-013bd6ecb38a 63187-271 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SYRUP ORAL 20060131 ANDA ANDA040650 Proficient Rx LP PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV E 20171231 63187-272_17bae9bf-ab07-4366-b400-871360c8969b 63187-272 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 20060214 ANDA ANDA040649 Proficient Rx LP DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 63187-273_3db76496-27c7-49c4-bcfd-2616e4d33d50 63187-273 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19960917 ANDA ANDA074569 Proficient Rx LP CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-274_9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc 63187-274 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072235 Proficient Rx LP BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 63187-276_88be694b-bdb6-4a00-96ef-3ee81c06e48c 63187-276 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate OINTMENT TOPICAL 20020901 ANDA ANDA070051 Proficient Rx LP BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-277_e1f930f0-a446-4c74-a6e2-1eb16c9c44bc 63187-277 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 Proficient Rx LP RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63187-278_321f6db8-ff21-4063-ab82-660ba4f6cf12 63187-278 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19940128 ANDA ANDA074215 Proficient Rx LP ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63187-280_b56c1356-538d-48e3-9a0f-3867aedb796f 63187-280 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20051201 ANDA ANDA077241 Proficient Rx LP BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 63187-281_991f2fe9-6943-4e2c-b901-1d8e10b6db10 63187-281 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Proficient Rx LP ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-282_c1c4c482-abe7-4649-bb94-51aa61df5021 63187-282 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 Proficient Rx LP INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-283_5d9b2c1d-565e-4c43-96ef-e5cd2593d0a8 63187-283 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Proficient Rx LP TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-284_c7ea94a0-c0d4-448e-af8a-a74e0ba27c9b 63187-284 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110718 ANDA ANDA065507 Proficient Rx LP AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 63187-285_bf9ab6c2-c429-42ff-a035-dc7a6d58e9b5 63187-285 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 Proficient Rx LP SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 63187-286_a8017f39-202d-41dd-957c-42309571c8b4 63187-286 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone dipropionate CREAM, AUGMENTED TOPICAL 20031209 ANDA ANDA076215 Proficient Rx LP BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63187-287_2fc6cdff-82ca-411c-a7a1-73fbb9940d12 63187-287 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 Proficient Rx LP CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 63187-288_2bf06b19-4ed7-41a3-b6fc-29713c41965c 63187-288 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20041221 ANDA ANDA076679 Proficient Rx LP MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63187-289_b08de8f6-f755-49ea-88c8-5c22b0cdbc4c 63187-289 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA078605 Proficient Rx LP MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 63187-290_e9125c9b-fc5b-4c87-b189-e8f871135ac9 63187-290 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 NDA NDA018851 Proficient Rx LP INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63187-291_b14edc3f-4490-4ad1-ad72-185b627a033c 63187-291 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEINE PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA087508 Proficient Rx LP ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 63187-292_d6adc880-5499-4691-93f3-27c87902d5fc 63187-292 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20090901 NDA NDA022352 Proficient Rx LP COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] E 20171231 63187-293_b6e2dcf6-bf96-4767-bff0-0b9c520ff45d 63187-293 HUMAN OTC DRUG PlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg Acetaminophen TABLET ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 Proficient Rx LP ACETAMINOPHEN 500 mg/1 N 20181231 63187-295_d1ab0bd3-5791-4897-aefe-7f7b32ed1129 63187-295 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 Proficient Rx LP AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-296_aeb4ce44-ab34-4f0e-a674-de42d404d104 63187-296 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20150819 ANDA ANDA203835 Proficient Rx LP LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-297_7d114b84-fc5d-4aec-b69e-8c4f081b3bc1 63187-297 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, EXTENDED RELEASE ORAL 20130110 OTC MONOGRAPH FINAL part343 Proficient Rx LP ASPIRIN 81 mg/1 E 20171231 63187-298_f29c792c-6cb2-449f-b97d-6304a58dec2a 63187-298 HUMAN OTC DRUG GOODSENSE ARTIFICIAL TEARS POLYVINYL ALCOHOL SOLUTION OPHTHALMIC 20100722 OTC MONOGRAPH FINAL part349 Proficient Rx LP POLYVINYL ALCOHOL; POVIDONES 5; 6 mg/mL; mg/mL N 20181231 63187-299_e1166948-5d80-44c2-a20d-78be631647d9 63187-299 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Proficient Rx LP BACITRACIN 500 [iU]/g N 20181231 63187-300_8193c549-3b9f-46be-8fd7-2d279e981ad5 63187-300 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Proficient Rx LP PREDNISONE 10 mg/1 N 20181231 63187-301_c91e5933-1798-4096-9f08-fb1200e154e1 63187-301 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20150923 ANDA ANDA207446 Proficient Rx LP CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-302_09442806-db7b-49de-8ffc-e4cb83138349 63187-302 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 20131202 ANDA ANDA074673 Proficient Rx LP GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63187-303_7bba97e5-2b5e-4569-8827-3f30a1660f13 63187-303 HUMAN OTC DRUG Hydrocortisone hydrocortisone CREAM TOPICAL 20011001 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP HYDROCORTISONE 10 mg/g E 20171231 63187-304_d3291474-8ef2-4cd8-aecc-2f550fd6a299 63187-304 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 Proficient Rx LP LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 63187-305_ca1a6552-d082-4312-ba17-0055e8554eb9 63187-305 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Proficient Rx LP LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 E 20171231 63187-306_5c1a89de-6191-4012-8bc2-8bfc42b89cbd 63187-306 HUMAN OTC DRUG Rugby Travel Sickness Meclizine HCl, 25 mg Each (ANTIEMETIC) Meclizine HCl TABLET, CHEWABLE ORAL 20140819 OTC MONOGRAPH FINAL part336 Proficient Rx LP MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 63187-307_079a8a9e-6d71-414a-83f3-ef68e323c1fd 63187-307 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 Proficient Rx LP NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63187-308_98042cef-2839-49d6-a7bd-a1d29c74430b 63187-308 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 Proficient Rx LP HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 63187-309_9b83bf07-84b8-495d-8a10-b74475fe2b32 63187-309 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Proficient Rx LP DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-311_d8242d35-ee3a-4008-81a0-70cdd84a1e7c 63187-311 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20110425 ANDA ANDA090370 Proficient Rx LP VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 63187-312_75b3f944-b4fc-40a5-a4e2-aec2fbab64b8 63187-312 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Proficient Rx LP VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63187-313_b56c1356-538d-48e3-9a0f-3867aedb796f 63187-313 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20051201 ANDA ANDA077241 Proficient Rx LP BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 63187-314_2d7577b7-3fff-44e4-b840-200a14a8856a 63187-314 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Proficient Rx LP METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-315_0bc40a61-5631-4e11-83b6-f24aaea33918 63187-315 HUMAN OTC DRUG banophen Diphenhydramine HCl LIQUID ORAL 20061120 OTC MONOGRAPH FINAL part341 Proficient Rx LP DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 63187-316_28e7fd03-42bc-44fd-846d-41df31788746 63187-316 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20120104 ANDA ANDA090428 Proficient Rx LP LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63187-317_4f5973e7-6eb1-4708-9468-fec86870b03e 63187-317 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 Proficient Rx LP CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-319_d1987535-992f-42ff-9746-408c3977f7eb 63187-319 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061004 ANDA ANDA077912 Proficient Rx LP HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-320_997308c9-7bc4-424e-8086-15581586f233 63187-320 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 19901022 NDA NDA050725 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 63187-321_fcb7d340-a167-41f2-b85d-916c542067da 63187-321 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076133 Proficient Rx LP OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 63187-322_8babce09-077e-490f-a6e9-983c0cdde27b 63187-322 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073553 Proficient Rx LP NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63187-323_42df5150-7e9b-4ed8-bca2-2678a807b1c7 63187-323 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20090210 ANDA ANDA076572 Proficient Rx LP SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63187-324_7df11f3e-f79b-4d52-a94b-4c0a31ebfe41 63187-324 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19860710 ANDA ANDA070920 Proficient Rx LP TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63187-325_49ad3f8d-ffdd-4de3-831f-c506ae8a9646 63187-325 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Proficient Rx LP AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-326_3d5c59f9-16df-4100-a4ac-b29252107751 63187-326 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 Proficient Rx LP AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63187-327_6ff04525-4f64-40d3-a45d-23cf8afb9cbf 63187-327 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 63187-328_7ee1e2e1-a024-4365-937c-e5a0dc41438f 63187-328 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20050121 ANDA ANDA076673 Proficient Rx LP CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63187-329_20bcefd9-3cd0-4850-af39-aa9d15fe8857 63187-329 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076133 Proficient Rx LP OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 63187-330_eb47a42a-5cc1-4117-8d6a-8fcda2ebfb10 63187-330 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 Proficient Rx LP ESZOPICLONE 2 mg/1 CIV E 20171231 63187-331_ba078ee5-b1df-4109-bf5f-47b2d0b001dc 63187-331 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 ANDA ANDA020998 Proficient Rx LP CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63187-332_f66c800c-5ad4-48f7-ac0d-c7e7f05f0f7a 63187-332 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20140201 ANDA ANDA203769 Proficient Rx LP METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63187-333_5c2e1f52-4021-4f70-9b2b-63af17094187 63187-333 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20040202 ANDA ANDA074151 Proficient Rx LP CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 63187-334_2f2c6768-58f2-43bf-9b56-77b7c27a3ccc 63187-334 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 Proficient Rx LP FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 63187-335_e40f3e20-facf-46f4-89c7-3593bc27d0fc 63187-335 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Proficient Rx LP AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 63187-336_c5a6c5d2-02c3-4947-82de-da1ff335f130 63187-336 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Proficient Rx LP ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63187-337_31dacbaf-4245-4172-9da4-514be309f341 63187-337 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET, EXTENDED RELEASE ORAL 20060126 ANDA ANDA077391 Proficient Rx LP ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63187-338_c53f033b-212a-4c12-b205-b17241d93d00 63187-338 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SYRUP ORAL 19821115 ANDA ANDA087953 Proficient Rx LP PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 63187-339_93ab9b1d-7149-4fd9-ab6e-615fad079cd3 63187-339 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE ORAL 20080407 ANDA ANDA040587 Proficient Rx LP BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 63187-340_e9f273e3-2748-49e5-b8b2-222c70808c58 63187-340 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Proficient Rx LP OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-341_226ce7e2-a0dd-4430-b19c-2ed9cc45a74e 63187-341 HUMAN OTC DRUG Siltussin SA Guaifenesin LIQUID ORAL 19981005 OTC MONOGRAPH FINAL part341 Proficient Rx LP GUAIFENESIN 100 mg/5mL E 20171231 63187-342_91ac5740-4acd-48fb-bd11-b0b38bd470d6 63187-342 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 ANDA ANDA090478 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-343_52e676e4-b70e-4e73-bbe7-f54d91ca7e0a 63187-343 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 19930101 ANDA ANDA064013 Proficient Rx LP AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 63187-344_e1293a07-6328-4bc2-8959-e146e518cdcd 63187-344 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET ORAL 20121029 OTC MONOGRAPH FINAL part341 Proficient Rx LP PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 63187-345_8701cd25-7cce-4e9c-b0aa-8c24e7099f99 63187-345 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Proficient Rx LP LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-346_c5a6c5d2-02c3-4947-82de-da1ff335f130 63187-346 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Proficient Rx LP ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63187-347_8d992a4c-8740-4636-928f-bb808eae3336 63187-347 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Proficient Rx LP LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63187-348_fd895819-b7d4-43bd-b804-f7b0722a00e9 63187-348 HUMAN PRESCRIPTION DRUG Dexlido-M Kit Dexamethasone Sodium Phosphate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine KIT 20140725 ANDA ANDA040491 Proficient Rx LP E 20171231 63187-349_1156c8a9-e2c1-49cb-b395-93959820c14f 63187-349 HUMAN PRESCRIPTION DRUG Interarticular Joint Kit AMMONIA, LIDOCAINE HYDROCHLORIDE ANHYDROUS, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINE KIT 20140205 NDA NDA014901 Proficient Rx LP E 20171231 63187-350_92cb6339-75ab-48eb-b304-19db59695883 63187-350 HUMAN PRESCRIPTION DRUG Multi-Specialty Kit Depo-Medrol, Lidocaine, Isopropyl Alcohol KIT 20140206 NDA NDA011757 Proficient Rx LP E 20171231 63187-352_f23a3dc4-62e9-46d0-a4b7-383dd5e02911 63187-352 HUMAN PRESCRIPTION DRUG Physicians EZ Use M-pred METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE KIT 20130530 NDA NDA016964 Proficient Rx LP E 20171231 63187-353_961303f6-d6fa-4d85-99b8-d155dff9f184 63187-353 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20070418 ANDA ANDA076591 Proficient Rx LP MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-354_73993c7e-acd7-4835-be03-f8274a15955b 63187-354 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 Proficient Rx LP HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63187-355_0f573b43-605a-4000-a7e9-a605e7eb8ed0 63187-355 HUMAN PRESCRIPTION DRUG Dextromethorphan Hydrobromide and Promethazine Hydrochloride Dextromethorphan Hydrobromide and Promethazine Hydrochloride SYRUP ORAL 19850104 ANDA ANDA088864 Proficient Rx LP DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63187-356_d7cbfe96-2b1a-44a4-a8af-5db2098c7eaf 63187-356 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Proficient Rx LP DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 63187-357_435c5544-491b-476a-b950-712b2c18e334 63187-357 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20150819 ANDA ANDA203835 Proficient Rx LP LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-358_41d3ab02-326b-4cb2-b83a-3af74171356a 63187-358 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 Proficient Rx LP TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63187-359_81c4f52a-f014-411c-a92b-3acf7ed61f31 63187-359 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Proficient Rx LP AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63187-360_6bdbc193-d86b-4bd5-8e88-4ea964d2cdde 63187-360 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Proficient Rx LP LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63187-361_a6457d6e-5586-40e9-883d-352ee0527d80 63187-361 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20150316 ANDA ANDA204597 Proficient Rx LP FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-362_25ed3120-7960-4e87-8422-de5c2026062c 63187-362 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA076999 Proficient Rx LP CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 63187-363_9115147f-57c7-4d08-9514-377ec96e9e95 63187-363 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120117 ANDA ANDA202677 Proficient Rx LP OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63187-364_1f4a2eaf-3a12-4ebe-b97f-0a7bfbc32572 63187-364 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Proficient Rx LP OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-365_9ea71469-0d99-4993-ac31-dbe071712123 63187-365 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 Proficient Rx LP ESZOPICLONE 3 mg/1 CIV N 20181231 63187-366_3da54b2d-a206-4ff5-8cc2-90762c4fd70d 63187-366 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Proficient Rx LP ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63187-367_19e8402c-ffbe-4639-8be6-8ea9747d8375 63187-367 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 Proficient Rx LP HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-368_199d6173-3fad-49e4-88fe-bde7223ed4c3 63187-368 HUMAN OTC DRUG GAVILAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091009 ANDA ANDA091077 Proficient Rx LP POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 63187-369_f047440d-12f9-4aeb-9492-a6dbb6412e09 63187-369 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20150713 ANDA ANDA200958 Proficient Rx LP METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-370_5606fdd8-4104-4ab6-b038-f9f033e11945 63187-370 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA090364 Proficient Rx LP AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63187-371_25d5ceab-a04b-4cf0-bc48-3d0c6d8af006 63187-371 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 Proficient Rx LP TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63187-372_91b05ec6-9624-4a97-bf2a-951f0e6ed526 63187-372 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Proficient Rx LP GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63187-373_43fd900c-50c8-49c4-9f07-4fef924d533c 63187-373 HUMAN OTC DRUG acetaminophen for children Acetaminophen SUPPOSITORY RECTAL 20101214 ANDA ANDA070607 Proficient Rx LP ACETAMINOPHEN 120 mg/1 N 20181231 63187-374_4712e069-83b6-4052-8d95-f59ab1dba744 63187-374 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Proficient Rx LP ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-375_82b24978-8b15-43a9-b5b0-3313ed2a73c2 63187-375 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 Proficient Rx LP HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 63187-376_9eb306e0-ccfb-418c-82ca-204f20a788f7 63187-376 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20151204 ANDA ANDA203584 Proficient Rx LP CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63187-377_de2aa5b8-c443-476f-abb1-69e1a8e29595 63187-377 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072193 Proficient Rx LP TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63187-378_4803746e-3105-423e-b8c6-3735718798e0 63187-378 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Proficient Rx LP NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-379_4f343cf8-ed33-4c2a-9359-78ac45831161 63187-379 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Proficient Rx LP ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-380_1a61fff8-8346-472e-9e06-cecbff8c7caa 63187-380 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20060203 ANDA ANDA071611 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-381_9ff60c5e-a20d-4664-827b-b73153d0f723 63187-381 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20160314 ANDA ANDA063029 Proficient Rx LP CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63187-382_0df6fd1e-7d9c-4a38-848c-1e562e211c91 63187-382 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Proficient Rx LP MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 63187-383_35307d74-aed8-4c6b-9568-2223a4f350bd 63187-383 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19820826 ANDA ANDA087916 Proficient Rx LP DEXAMETHASONE 2 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-384_f858c018-56a0-4be7-93d1-129670402722 63187-384 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 Proficient Rx LP LEVOFLOXACIN 750 mg/1 N 20181231 63187-391_857945c0-0ba7-4d0d-ab42-e6087b40fb5b 63187-391 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Proficient Rx LP LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-392_5ab67a63-59c8-43bd-a475-5d6f748b6db0 63187-392 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Proficient Rx LP GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63187-393_be41d21c-4747-47bb-b4b7-bbfabcd7a9b1 63187-393 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Proficient Rx LP BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63187-394_6dd115b5-9268-4b66-bae8-0aa2605ebbd3 63187-394 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160523 ANDA ANDA091617 Proficient Rx LP LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-395_bd9f3220-6d42-4863-aa2a-b17b138d095d 63187-395 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin, Polymyxin B Sulfates, Dexamethasone OINTMENT OPHTHALMIC 20140703 ANDA ANDA062938 Proficient Rx LP DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-396_59a65e6f-b812-4195-b85b-c412fb902c93 63187-396 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Proficient Rx LP NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63187-397_44b25524-df4f-42d5-92a7-03570d5d5c7e 63187-397 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Proficient Rx LP ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63187-398_4b61f88c-7a95-4a0b-be0c-de97eb99dcd5 63187-398 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA090528 Proficient Rx LP HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-399_35bfb64d-faa1-4d78-a5ab-17ba4ed9711e 63187-399 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Proficient Rx LP AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-400_871632bb-0525-4e3b-a3ab-a50393bc9634 63187-400 HUMAN PRESCRIPTION DRUG Brompheniramine Maleate, Pseudoephedrine Hydrochloride and DextromethorphanHydrobromide Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide SYRUP ORAL 20100615 ANDA ANDA088811 Proficient Rx LP BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 2; 30; 10 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] E 20171231 63187-401_31d6a5a0-eaf0-4c7c-8d50-742ae520cca9 63187-401 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110529 ANDA ANDA090768 Proficient Rx LP DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 63187-402_b81e576c-8418-4698-935c-29ec8644e237 63187-402 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075022 Proficient Rx LP BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 63187-403_a96e0d95-1a7b-4588-923a-2169b5506203 63187-403 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Proficient Rx LP MIRTAZAPINE 30 mg/1 E 20171231 63187-404_af650f42-a90a-4ed4-898c-f9a2a0000df2 63187-404 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Proficient Rx LP METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 63187-405_4b61f88c-7a95-4a0b-be0c-de97eb99dcd5 63187-405 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA090528 Proficient Rx LP HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-406_691b3b5c-8757-4eec-b873-ad651f3f1ae5 63187-406 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone hydrochloride and Acetaminophen TABLET ORAL 19960730 ANDA ANDA040105 Proficient Rx LP OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63187-407_9256da8e-115d-4fde-b343-ae643f044e3a 63187-407 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071974 Proficient Rx LP PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 63187-408_d07e6a77-0a5a-4f23-8362-24c44ac1b37b 63187-408 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Proficient Rx LP AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63187-409_cd7e7c34-6958-47be-a1c1-f1ed948e2687 63187-409 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Proficient Rx LP CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 63187-410_646eca5c-aa3c-455f-8c41-164066477996 63187-410 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19990226 ANDA ANDA040230 Proficient Rx LP DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 63187-411_eb6a5fc6-afb9-48b3-b2fe-b92490d8969f 63187-411 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20091105 UNAPPROVED DRUG OTHER Proficient Rx LP HYOSCYAMINE SULFATE .125 mg/1 E 20171231 63187-412_eee62a16-5d68-4639-8aec-63189f3afe60 63187-412 HUMAN PRESCRIPTION DRUG Naphazoline Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19951219 ANDA ANDA083590 Proficient Rx LP NAPHAZOLINE HYDROCHLORIDE 1 mg/mL E 20171231 63187-413_d9311ea1-dfa8-4f00-94ef-84b8a41d51ee 63187-413 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Proficient Rx LP PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63187-414_b5fc0187-590c-4bb9-a910-821eb0dc1fc8 63187-414 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 Proficient Rx LP VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63187-415_d9311ea1-dfa8-4f00-94ef-84b8a41d51ee 63187-415 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Proficient Rx LP PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63187-416_914bfba9-6602-4bbd-9313-20b84d2e0e37 63187-416 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Proficient Rx LP BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 63187-417_ddf052a3-23a5-4d8c-a684-e8d464f1ab03 63187-417 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061227 ANDA ANDA077657 Proficient Rx LP LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63187-418_b611fe52-1787-47e6-8a6b-1999a4e4f22c 63187-418 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Proficient Rx LP RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] E 20171231 63187-419_44fc50e8-789a-425b-9347-c04f6def1538 63187-419 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Proficient Rx LP CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 63187-420_e3a190e9-9e7f-4291-ac7c-e3c2782bbb82 63187-420 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Proficient Rx LP VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-422_b9d5a099-00ef-40b6-90a4-254f2be551d5 63187-422 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 20100721 ANDA ANDA062949 Proficient Rx LP NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 63187-423_59f58a6c-b7c9-4289-8092-8ca73cd36cf3 63187-423 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021121 ANDA ANDA065093 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 63187-424_d5822e3c-413c-4c7e-bbec-d0d42d2028ba 63187-424 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Proficient Rx LP CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 63187-425_7f33549f-69c0-4564-bd40-30e0f34313cd 63187-425 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20120120 ANDA ANDA078457 Proficient Rx LP QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-426_a6d114ab-9c36-4747-a1df-81d26c5fe07a 63187-426 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Proficient Rx LP SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 63187-427_411caa05-5eff-4285-a940-7f6d2429ba81 63187-427 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Proficient Rx LP VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-428_a264e46d-44f2-4e0b-9df9-9d482787a138 63187-428 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA091519 Proficient Rx LP VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-429_da4d80b1-3153-4225-8b63-53a1b922ce67 63187-429 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Proficient Rx LP OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-430_d2eb5ced-697c-4c08-b031-d45389d208ed 63187-430 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20120803 ANDA ANDA201515 Proficient Rx LP MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 63187-431_15ec3de1-7343-46ba-bd6b-3194018e4bf5 63187-431 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Proficient Rx LP ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-432_47a60763-671e-413b-b962-f7f11ba2f4d7 63187-432 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20080528 ANDA ANDA078541 Proficient Rx LP MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63187-433_0cf946ec-c577-44a2-9c9d-ea68eae72e89 63187-433 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20080923 ANDA ANDA078930 Proficient Rx LP BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-434_8b451673-3b4b-4f3a-bdf8-72ac0b253a44 63187-434 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Proficient Rx LP PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-435_150c80f1-8fba-498c-95b9-250cc78bc59b 63187-435 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 Proficient Rx LP CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 63187-436_26d8bc1c-59bc-425a-bdb0-5f97e6dcdbe0 63187-436 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20131203 ANDA ANDA078488 Proficient Rx LP CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 63187-437_97fdbf93-8afc-4bcb-9252-0cc6911ba95f 63187-437 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Proficient Rx LP FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 63187-438_9e6845f5-bd94-476e-9fc9-80d3af999cab 63187-438 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Proficient Rx LP LEVOFLOXACIN 500 mg/1 N 20181231 63187-439_a5cab952-2b58-4a80-8bfe-501fea4c48bb 63187-439 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140423 ANDA ANDA201003 Proficient Rx LP RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-440_94cafc74-c35c-42fc-952e-d682d032276e 63187-440 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070601 ANDA ANDA040702 Proficient Rx LP HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-441_94cafc74-c35c-42fc-952e-d682d032276e 63187-441 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070601 ANDA ANDA040702 Proficient Rx LP HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-442_b5ae698a-b918-4bff-bee9-e1a2e78abf4e 63187-442 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Proficient Rx LP LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-443_9f749fad-e3d8-490b-9ca7-5915bd55131c 63187-443 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Proficient Rx LP ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-444_9f749fad-e3d8-490b-9ca7-5915bd55131c 63187-444 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19980325 ANDA ANDA074909 Proficient Rx LP ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-445_34631dbf-f817-484d-8bcf-f8efa07178d7 63187-445 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20110607 ANDA ANDA090871 Proficient Rx LP ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63187-446_1938e88e-c719-495b-a856-4846b52b2292 63187-446 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Proficient Rx LP DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 63187-447_cd7e7c34-6958-47be-a1c1-f1ed948e2687 63187-447 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Proficient Rx LP CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 63187-448_15ec3de1-7343-46ba-bd6b-3194018e4bf5 63187-448 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Proficient Rx LP ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-449_27d6b334-9921-4a6c-8d0d-01682e0265fc 63187-449 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Proficient Rx LP SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-450_407f9cad-8976-4d84-8570-37857d1c65c6 63187-450 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Proficient Rx LP MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 63187-451_924d2dd0-3b7d-42ec-b617-86729dba2b95 63187-451 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120222 ANDA ANDA090796 Proficient Rx LP IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63187-452_db53c376-d656-4565-a6a8-fc2f429f45fa 63187-452 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Proficient Rx LP QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-453_da4d80b1-3153-4225-8b63-53a1b922ce67 63187-453 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Proficient Rx LP OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-454_2fc6cdff-82ca-411c-a7a1-73fbb9940d12 63187-454 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 Proficient Rx LP CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 63187-455_11fb6a03-030d-4e6f-8d0e-40fab2b66ae3 63187-455 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Proficient Rx LP NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63187-456_6cbd8853-718d-42ba-bc27-e3983eefb804 63187-456 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Proficient Rx LP TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 63187-457_510ceafd-8254-428c-b2ff-a167f283cda7 63187-457 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 Proficient Rx LP DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63187-458_c1fc22e5-e02d-4dda-a9ac-c592e922c467 63187-458 HUMAN PRESCRIPTION DRUG Tri-Sprintec norgestimate and ethinyl estradiol KIT 20031229 ANDA ANDA075808 Proficient Rx LP E 20171231 63187-459_ebf1e6c1-da3d-4ee2-872b-2585a14107ac 63187-459 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Proficient Rx LP LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 63187-460_ebf1e6c1-da3d-4ee2-872b-2585a14107ac 63187-460 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Proficient Rx LP LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 63187-461_aa4d159c-9cbe-4d29-9532-33a312f1ae05 63187-461 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Proficient Rx LP NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-462_82e65393-25b7-4114-9c71-5840ee8bad84 63187-462 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Proficient Rx LP LOPERAMIDE HYDROCHLORIDE 2 mg/1 E 20171231 63187-463_0ca4baed-c5d8-4de4-ac17-6e5d1df15c03 63187-463 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018832 Proficient Rx LP ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 63187-464_d7d04c02-d07d-4382-8f93-5c0c3e68790c 63187-464 HUMAN PRESCRIPTION DRUG Nystatin Nystatin OINTMENT TOPICAL 20020903 ANDA ANDA062840 Proficient Rx LP NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 63187-465_f11598d2-87ee-4292-8631-c29c54f4dfa9 63187-465 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19970605 ANDA ANDA074821 Proficient Rx LP TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] E 20171231 63187-466_246703b1-a792-4653-a391-02d3c6212cb7 63187-466 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Proficient Rx LP PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63187-467_d1987535-992f-42ff-9746-408c3977f7eb 63187-467 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20060410 ANDA ANDA077912 Proficient Rx LP HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-468_ec4fd5ce-9057-4cc6-9c58-872073dc9cc1 63187-468 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Proficient Rx LP CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV E 20171231 63187-469_7ab67729-1947-48ed-89d7-cd5e0b3b2dea 63187-469 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 Proficient Rx LP TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63187-470_609dd837-ac5c-4905-8a34-bda21da585c7 63187-470 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Proficient Rx LP CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 63187-471_9b1dfb56-f84b-4669-a472-598a91cd1d6d 63187-471 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Proficient Rx LP MIRTAZAPINE 45 mg/1 N 20181231 63187-472_d5077029-e03c-44e7-84a0-5167ad6049eb 63187-472 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION AURICULAR (OTIC) 20080317 ANDA ANDA076128 Proficient Rx LP OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63187-473_f6b85581-32f9-4309-98c2-a7d440479f18 63187-473 HUMAN PRESCRIPTION DRUG Cromolyn Sodium cromolyn sodium SOLUTION/ DROPS OPHTHALMIC 19980526 ANDA ANDA074443 Proficient Rx LP CROMOLYN SODIUM 40 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 63187-474_c786e0a8-0891-4edb-a689-1edfa85dbec9 63187-474 HUMAN PRESCRIPTION DRUG Methylprednisolone Acetate Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20050308 ANDA ANDA040557 Proficient Rx LP METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-475_21428b26-62e7-4e69-ac6e-3a2c767fa99f 63187-475 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021106 ANDA ANDA076201 Proficient Rx LP DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 63187-476_f9ac0344-5864-4ac1-81bc-16878a5946c5 63187-476 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 Proficient Rx LP DOCUSATE SODIUM 100 mg/1 N 20181231 63187-477_1d32cb15-dd59-43c5-87cc-6e5d843cfa57 63187-477 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110301 ANDA ANDA074550 Proficient Rx LP GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 63187-478_e084d4be-d68e-419f-91ac-8b57305cf4c2 63187-478 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Proficient Rx LP SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-479_5d9b2c1d-565e-4c43-96ef-e5cd2593d0a8 63187-479 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Proficient Rx LP TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-480_d50240db-f630-4008-a272-55ba5c991304 63187-480 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20020930 ANDA ANDA089682 Proficient Rx LP HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63187-481_80f0a716-0ede-4b6a-88af-68b85bd90c32 63187-481 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Proficient Rx LP VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-482_25da9786-a582-47cb-95ec-f0d122afa36e 63187-482 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Proficient Rx LP ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 63187-483_026c4323-519e-469c-997a-d1eab539a4b3 63187-483 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070813 ANDA ANDA078050 Proficient Rx LP ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-484_b3edf278-6624-4c74-bcda-33e20f75c9c3 63187-484 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Proficient Rx LP NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-486_f76994e3-4596-47d3-a743-faeb508328b0 63187-486 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Proficient Rx LP GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63187-487_6234e208-4f43-4818-b91f-5f2288bb16a6 63187-487 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 Proficient Rx LP LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 63187-488_01b4de35-0a7c-481b-bd6d-f6775413d120 63187-488 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20020314 ANDA ANDA065063 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 63187-489_3ae84988-2aa8-4452-9335-d79a9c5b9737 63187-489 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Proficient Rx LP IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-490_1f5c0cc8-81c5-4c9e-9880-138ad1fd6514 63187-490 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20130531 ANDA ANDA203399 Proficient Rx LP METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 63187-491_600b35be-5fc1-4c45-8377-033b6467db0c 63187-491 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 Proficient Rx LP ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 63187-492_7f4f3b98-6745-49a7-a5df-158f6f70eaad 63187-492 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 Proficient Rx LP HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63187-493_6d0007fb-8070-4d33-9693-fcc394a6a1be 63187-493 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130401 ANDA ANDA091283 Proficient Rx LP TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63187-494_7c183fff-140d-44e0-9c3c-cb7606cd6344 63187-494 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride SYRUP ORAL 19950309 ANDA ANDA087294 Proficient Rx LP HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63187-495_d8bc66af-23e1-4a29-bfb2-6cdb9ccb11c7 63187-495 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20061110 ANDA ANDA087385 Proficient Rx LP TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-496_ebf1e6c1-da3d-4ee2-872b-2585a14107ac 63187-496 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Proficient Rx LP LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 63187-497_5aaf8c99-cd58-47fc-8bf5-1039a6315ca5 63187-497 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 Proficient Rx LP TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63187-498_ab89d2c3-f3d1-48e6-bb30-e187d991b234 63187-498 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19950913 ANDA ANDA064135 Proficient Rx LP NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-499_09b2898d-8b66-4583-9969-94a733ebff48 63187-499 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Proficient Rx LP BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63187-500_09b2898d-8b66-4583-9969-94a733ebff48 63187-500 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Proficient Rx LP BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63187-501_9e5ac3c5-dd65-4418-92e1-2147e838cac6 63187-501 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 19950601 OTC MONOGRAPH FINAL part333C Proficient Rx LP CLOTRIMAZOLE 1 g/100g N 20181231 63187-502_3e2fa56c-0239-4cc8-a2f9-958a9203b58d 63187-502 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 19980301 ANDA ANDA040268 Proficient Rx LP PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63187-503_e1f930f0-a446-4c74-a6e2-1eb16c9c44bc 63187-503 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 Proficient Rx LP RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63187-504_c505afa1-9e50-4659-b0fe-028e6bad8a6d 63187-504 HUMAN OTC DRUG Hydrocortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP HYDROCORTISONE 1 g/100g N 20181231 63187-505_0a6b58f1-db4e-432a-bd20-7cb90ec9fc03 63187-505 HUMAN OTC DRUG Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20131101 OTC MONOGRAPH FINAL part346 Proficient Rx LP MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 63187-506_856c1969-3fb1-4b03-98c0-737317bc8505 63187-506 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Proficient Rx LP FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 63187-507_4a268f5c-c1bc-4f0d-995f-2726ac9a7483 63187-507 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20031023 ANDA ANDA040525 Proficient Rx LP PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 63187-508_c4c3ab88-fe4e-4ba1-b96a-a0f2edc0670d 63187-508 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 Proficient Rx LP AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63187-509_da785f21-58d5-45e5-90a9-6fd4b0be0ea2 63187-509 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Proficient Rx LP OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 63187-510_3e3e63df-e2ad-420b-acb9-28e65ea6fb07 63187-510 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 Proficient Rx LP LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 63187-511_205054e1-8172-47dc-931c-a18a60e7e9f0 63187-511 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 Proficient Rx LP METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 63187-512_82c1c374-debe-4b30-9343-8529ddf1a309 63187-512 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Proficient Rx LP PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 63187-513_bde7c22c-0047-4735-8df6-b48e8dfa478a 63187-513 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Proficient Rx LP ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 63187-514_6e77bd45-bd4b-4ec3-94cd-f6c3858aeaf8 63187-514 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Proficient Rx LP LEVOFLOXACIN 750 mg/1 E 20171231 63187-515_1b55ac44-8a3a-48b1-ba01-32d48b7c03ac 63187-515 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20050415 ANDA ANDA040555 Proficient Rx LP PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 63187-516_4242fb32-a04f-4f46-99e2-ca01fcb2ee9f 63187-516 HUMAN OTC DRUG PlusPHARMA Simethicone TABLET, CHEWABLE ORAL 20060327 OTC MONOGRAPH FINAL part347 Proficient Rx LP DIMETHICONE 80 mg/1 E 20171231 63187-517_856c1969-3fb1-4b03-98c0-737317bc8505 63187-517 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Proficient Rx LP FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 63187-518_969acb29-3b5c-47ed-8f7d-a960a24e72e3 63187-518 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20110607 ANDA ANDA090871 Proficient Rx LP ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63187-519_3800bad3-05e4-45bf-9947-874fe8a008b6 63187-519 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20140516 ANDA ANDA090455 Proficient Rx LP ERGOCALCIFEROL 1.25 1/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 63187-520_1bde13a5-cdd4-4bc2-8aeb-32e4dc157293 63187-520 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 19870121 ANDA ANDA089175 Proficient Rx LP BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 63187-521_47ceb7e1-b2f7-47f8-8b6a-85eea36606b8 63187-521 HUMAN PRESCRIPTION DRUG bupropion bupropion TABLET, EXTENDED RELEASE ORAL 20140215 ANDA ANDA201567 Proficient Rx LP BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63187-522_f5b4e308-c156-4865-95ee-1a8e267535ba 63187-522 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Proficient Rx LP DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-524_43a8c4e8-3679-485d-88fc-8bccdba7de1e 63187-524 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 19960507 ANDA ANDA074356 Proficient Rx LP CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 63187-525_cbb18010-f3b5-4ed7-8c03-c9203f0e360e 63187-525 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20031107 ANDA ANDA065085 Proficient Rx LP MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 63187-526_8ee5c003-beac-4725-8d05-52733fb89660 63187-526 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Proficient Rx LP ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-527_3ae84988-2aa8-4452-9335-d79a9c5b9737 63187-527 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Proficient Rx LP IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-528_dfa7d1e3-74b2-4f55-a38f-1dd5f0cdca53 63187-528 HUMAN OTC DRUG Plus Pharma Pain Reliever,Fever Reducer ACETAMINOPHEN TABLET ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 Proficient Rx LP ACETAMINOPHEN 325 mg/1 N 20181231 63187-529_cb23ee12-3b8a-4776-bcc0-23f0da66edb3 63187-529 HUMAN PRESCRIPTION DRUG ipratropium bromide and albuterol sulfate ipratropium bromide and albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20130513 ANDA ANDA202496 Proficient Rx LP IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 2.5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 63187-530_05a4814f-9bd8-48a6-a92b-626b006b7a0f 63187-530 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 Proficient Rx LP ASPIRIN 325 mg/1 N 20181231 63187-532_c5c8ca26-d3dd-46ba-bf04-6aae9f334445 63187-532 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Proficient Rx LP METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-533_26e05edf-ca50-4607-9176-0d55054a4d6e 63187-533 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19900930 ANDA ANDA060456 Proficient Rx LP PENICILLIN V POTASSIUM 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-534_e5fbefd1-4077-4e81-a0e3-e09fadc48593 63187-534 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Proficient Rx LP LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-535_3e4e5371-d796-47c7-95c1-d99e82a0b282 63187-535 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Proficient Rx LP NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-536_2764459e-83b9-4bbe-ac69-6164870223f9 63187-536 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Proficient Rx LP LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-537_2cbe6a5c-098a-4794-b8a0-e61364542db1 63187-537 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 Proficient Rx LP ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-538_efe37bd1-a236-43cc-828c-b57e8a704d67 63187-538 HUMAN PRESCRIPTION DRUG valacyclovir hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20120405 ANDA ANDA201506 Proficient Rx LP VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63187-539_a07c9b3d-64c6-4c8a-b0cc-7362c0e1df87 63187-539 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Proficient Rx LP HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63187-540_d9c3dbbd-4b4b-48a2-9085-298ebe963513 63187-540 HUMAN PRESCRIPTION DRUG PROAIR HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20121203 NDA NDA021457 Proficient Rx LP ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 63187-541_52ab64d7-b4c8-45d1-8e45-271f4dda1420 63187-541 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 Proficient Rx LP PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 N 20181231 63187-542_0f263ead-5be2-435e-9e5d-8f23fb1707e3 63187-542 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20040813 ANDA ANDA065098 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 63187-543_c57d5f8e-5934-4cbb-999a-cdd55e5b105f 63187-543 HUMAN OTC DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP HYDROCORTISONE 1 g/100g N 20181231 63187-544_f8d26f65-a015-4bfc-b1fa-8595d72af48c 63187-544 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071322 Proficient Rx LP DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-545_2e1edf39-0269-4d32-8583-28c2640f3193 63187-545 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA077118 Proficient Rx LP METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-546_2e1edf39-0269-4d32-8583-28c2640f3193 63187-546 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA076862 Proficient Rx LP METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-547_2e1edf39-0269-4d32-8583-28c2640f3193 63187-547 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Proficient Rx LP METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-548_2b421bcf-b7ca-4d81-a309-a52876555a8f 63187-548 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 Proficient Rx LP HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-549_d1e93782-aeab-41a7-88cb-9b287cf16ead 63187-549 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Proficient Rx LP LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63187-550_07d5fbea-b183-41c9-a20f-30da1f44ab1b 63187-550 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA090984 Proficient Rx LP MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 63187-551_7780b8f6-c9d5-4516-9f60-39f339c8fb29 63187-551 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071221 ANDA ANDA077056 Proficient Rx LP PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 63187-552_7897d182-2859-4a40-af4d-aaa9d9720fd9 63187-552 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077157 Proficient Rx LP LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-553_78c04f59-65c3-4a16-83a6-ed4a409afce5 63187-553 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130115 ANDA ANDA202556 Proficient Rx LP HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-554_a2f01ffd-fd48-499b-9126-8eb9048a5722 63187-554 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Proficient Rx LP MIRTAZAPINE 30 mg/1 N 20181231 63187-555_d1444508-fe40-4f68-8350-52f13399e38a 63187-555 HUMAN PRESCRIPTION DRUG Rabeprazole sodium Rabeprazole sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA202376 Proficient Rx LP RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 63187-556_a7770b19-f69d-43c9-9543-e2cc68884cde 63187-556 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20030318 ANDA ANDA063083 Proficient Rx LP CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63187-557_cfb42102-322d-409a-9da9-5d34733cc8ae 63187-557 HUMAN OTC DRUG good sense lice killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20071208 OTC MONOGRAPH FINAL part358G Proficient Rx LP PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 63187-558_e1f43bde-efba-42be-adef-94e1ef6664fd 63187-558 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Proficient Rx LP ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 63187-559_eeb241a3-93ee-4b74-8cbb-65713d15e7e0 63187-559 HUMAN OTC DRUG clotrimazole Clotrimazole CREAM TOPICAL 20110603 OTC MONOGRAPH FINAL part333C Proficient Rx LP CLOTRIMAZOLE 1 g/100g N 20181231 63187-560_3a6677a6-def5-443e-82bc-c185d41f03b7 63187-560 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 19940511 ANDA ANDA064048 Proficient Rx LP GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 63187-561_c1e73fd0-8c52-4b66-88b1-8f984d5d3a82 63187-561 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 Proficient Rx LP DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-562_6dd743d3-4821-4919-90eb-6d306ca7999f 63187-562 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 Proficient Rx LP CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-563_727a3c22-aec9-455d-a3c9-0f5a7bbf6981 63187-563 HUMAN PRESCRIPTION DRUG RIZATRIPTAN Benzoate RIZATRIPTAN Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203478 Proficient Rx LP RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63187-564_847118ec-c139-466c-834b-1ae0b6e1f791 63187-564 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20091203 ANDA ANDA078406 Proficient Rx LP PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-565_eaca34da-2b12-4dd4-91b5-a8446c7bd41e 63187-565 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Proficient Rx LP ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 63187-566_a165869a-9bc4-4987-babe-a77fad78c38f 63187-566 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Proficient Rx LP BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63187-567_14bd6309-ee5e-4425-81fc-943ee38451c4 63187-567 HUMAN OTC DRUG Hydrocortisone Maximum Strength with Aloe Hydrocortisone CREAM TOPICAL 20090421 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP HYDROCORTISONE 1 g/100g N 20181231 63187-568_f5ef71ae-fca9-4a57-ae88-f2b2d195a179 63187-568 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SOLUTION AURICULAR (OTIC) 20030318 ANDA ANDA062423 Proficient Rx LP NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [iU]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-569_542c4ebf-291d-4c05-b575-d010be2bc3da 63187-569 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Proficient Rx LP LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63187-570_0bfea06d-7abe-407a-80a4-d15d373569f7 63187-570 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Proficient Rx LP CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 63187-571_e1f94546-c71c-4175-9384-20238181e05f 63187-571 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Proficient Rx LP VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-572_542c4ebf-291d-4c05-b575-d010be2bc3da 63187-572 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Proficient Rx LP LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63187-573_542c4ebf-291d-4c05-b575-d010be2bc3da 63187-573 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Proficient Rx LP LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63187-574_9e5b3a11-9c4b-4998-8a18-3046af1314ab 63187-574 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 Proficient Rx LP ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63187-575_ccb62898-b614-45b9-95ea-23e5e31893a8 63187-575 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20010913 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP HYDROCORTISONE .5 g/100g N 20181231 63187-576_6a70427e-d3b9-47a2-b286-933f90cc7d57 63187-576 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Proficient Rx LP LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-577_64e62897-2d93-4154-859a-51b53eeafc1c 63187-577 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine lidocaine and prilocaine CREAM TOPICAL 20121112 NDA AUTHORIZED GENERIC NDA019941 Proficient Rx LP LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 63187-578_80c13492-3873-48ba-882f-58e02dc7237d 63187-578 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Proficient Rx LP ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-579_0a3441ae-9831-48e8-9444-510c9e7d226b 63187-579 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 Proficient Rx LP ESZOPICLONE 1 mg/1 CIV N 20181231 63187-580_026ab0eb-e31d-420c-b456-5add03fb612e 63187-580 HUMAN PRESCRIPTION DRUG alendronate sodium alendronate sodium TABLET ORAL 20080804 ANDA ANDA076984 Proficient Rx LP ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 63187-581_607a5eee-e702-459a-a18f-1bf81b97e560 63187-581 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Proficient Rx LP LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63187-582_9d6cf386-7fa1-433d-8fe9-4aa3617ba0e1 63187-582 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20071017 NDA NDA022122 Proficient Rx LP DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-583_85321a9a-08d9-49e4-8c79-86ecfc536613 63187-583 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060130 ANDA ANDA077651 Proficient Rx LP ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63187-584_4eaf5b04-c026-4a49-879f-2925b375f903 63187-584 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Proficient Rx LP FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 63187-585_c2cd7894-6b4e-417f-8ab0-5ad41d4390a0 63187-585 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20121015 ANDA ANDA090460 Proficient Rx LP ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 63187-586_b810b184-047a-442e-9de0-67df043fabca 63187-586 HUMAN OTC DRUG Pinworm Medicine Pyrantal pamoate SUSPENSION ORAL 20070101 OTC MONOGRAPH FINAL part357B Proficient Rx LP PYRANTEL PAMOATE 144 mg/mL N 20181231 63187-587_2b79565f-5038-4cc4-ad75-2c6692411405 63187-587 HUMAN OTC DRUG Mucus Relief Sinus Guaifenesin and Phenylephrine HCl TABLET ORAL 20060415 OTC MONOGRAPH FINAL part341 Proficient Rx LP GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 63187-588_99b6d834-bba0-442f-b19d-5a211360986a 63187-588 HUMAN OTC DRUG Childrens MAPAP Acetaminophen Acetaminophen LIQUID ORAL 20120820 OTC MONOGRAPH NOT FINAL part343 Proficient Rx LP ACETAMINOPHEN 160 mg/5mL N 20181231 63187-589_ddbde0ae-d95c-4d99-b759-0a6604cdce30 63187-589 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Proficient Rx LP LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-590_ae3a3f5c-fb64-4a43-be88-a2fc7c298ac1 63187-590 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20150325 ANDA ANDA078722 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-591_9528a356-4101-4be2-a7e2-b0659e169e1a 63187-591 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Proficient Rx LP AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-592_c20e6c9c-c70e-4be4-bbc3-c2191e911fac 63187-592 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20080118 ANDA ANDA065248 Proficient Rx LP CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 63187-593_50111641-bccc-4c03-91f8-15434bf8926a 63187-593 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140704 ANDA ANDA065418 Proficient Rx LP CEFDINIR MONOHYDRATE 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 63187-594_8146ad4f-fd84-4414-a899-b7ddd4a63bb5 63187-594 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 Proficient Rx LP AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 63187-595_0162023e-c473-44cd-91af-5dce361b0385 63187-595 HUMAN PRESCRIPTION DRUG promethazine hydrochloride and codeine phosphate promethazine hydrochloride and codeine phosphate SYRUP ORAL 20100317 ANDA ANDA090180 Proficient Rx LP PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 63187-596_e48a8165-8913-4c72-a2ea-8fc9b7367905 63187-596 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140411 ANDA ANDA074661 Proficient Rx LP NAPROXEN SODIUM 220 mg/1 N 20181231 63187-597_27495d02-8641-4c92-b5a3-edf50abc2a6f 63187-597 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20111212 ANDA ANDA201384 Proficient Rx LP TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 63187-598_f872733e-0b43-444f-8b44-3f9f28a13f87 63187-598 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 Proficient Rx LP IBUPROFEN 200 mg/1 N 20181231 63187-599_198d5151-7982-4639-9fe1-6573a4529348 63187-599 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Proficient Rx LP LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-600_df686c1d-f3b7-477e-8242-ebc8ce5f08da 63187-600 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Proficient Rx LP METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-601_050b3868-80ed-4e08-b0a9-6063505aabb9 63187-601 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Proficient Rx LP LORATADINE 10 mg/1 N 20181231 63187-602_198d5151-7982-4639-9fe1-6573a4529348 63187-602 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Proficient Rx LP LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-603_4dcb6785-e16b-4692-89b3-f905979ca5ae 63187-603 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 Proficient Rx LP CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-604_aefc926a-b318-49c3-aa9d-cfe2c4f19597 63187-604 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Proficient Rx LP AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 63187-605_61283c3b-9773-4cf8-bedf-ac3109684f55 63187-605 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 Proficient Rx LP HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63187-606_4a60b47e-b52a-42aa-a98f-f611cba373fa 63187-606 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20150810 ANDA ANDA202765 Proficient Rx LP BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 63187-607_d9c78ac5-7328-4204-8f66-96606d7db5c3 63187-607 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Proficient Rx LP SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63187-608_5101bf55-cacf-42bf-8dd1-2a29e80ca6f1 63187-608 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 Proficient Rx LP ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 63187-609_a93cc3fc-8c57-40ed-89c1-96983da835b3 63187-609 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Proficient Rx LP METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-610_956e602f-772d-441e-9bf5-d1560c5b9615 63187-610 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110222 NDA AUTHORIZED GENERIC NDA018279 Proficient Rx LP POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 63187-611_607a5eee-e702-459a-a18f-1bf81b97e560 63187-611 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021210 Proficient Rx LP LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63187-612_c34f6115-f447-450f-8c83-58f3c51a76c9 63187-612 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Proficient Rx LP DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-613_b19e48e5-97c6-4b38-8721-8747b9c1a36a 63187-613 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 Proficient Rx LP FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 63187-614_59717a5a-bc1a-49a8-b150-cb782addae4c 63187-614 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Proficient Rx LP IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-615_33e082f6-6df8-4da5-a47e-8e7f5af168d5 63187-615 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150701 NDA NDA022370 Proficient Rx LP TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 63187-616_f22acd90-5dc4-406d-af78-5f9c3a674647 63187-616 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070508 ANDA ANDA065332 Proficient Rx LP CEFDINIR MONOHYDRATE 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 63187-617_77a41cca-02d2-4b84-975e-d1925f0fca80 63187-617 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20091117 ANDA ANDA076847 Proficient Rx LP SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63187-618_0fefd790-b526-4f2f-8c83-5f39f7306556 63187-618 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate KIT 20060510 NDA NDA021928 Proficient Rx LP N 20181231 63187-619_ba7de15b-08dd-4bd7-936d-13c1008edbaf 63187-619 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20141126 ANDA ANDA203623 Proficient Rx LP SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 63187-620_27f8952a-189d-4687-854e-c51da619bf3d 63187-620 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041221 ANDA ANDA075317 Proficient Rx LP TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63187-621_15110f70-6602-4e05-a4b5-716a86dcaed5 63187-621 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride ER Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111024 ANDA ANDA091680 Proficient Rx LP DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 63187-622_9a2d1be5-ee03-4af9-8f9d-eb3cb06c71c6 63187-622 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065212 Proficient Rx LP AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 63187-625_b1bdf526-4f16-4130-b614-4cb678f060d7 63187-625 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20120725 ANDA ANDA065489 Proficient Rx LP CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63187-626_9705627c-283e-4743-b261-cfeb88d96e9b 63187-626 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, CHEWABLE ORAL 20141201 ANDA ANDA203037 Proficient Rx LP MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 63187-627_4043f83c-2bb7-4590-b3df-0658f5e627ac 63187-627 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20100524 ANDA ANDA077135 Proficient Rx LP VALACYCLOVIR HYDROCHLORIDE 1000 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63187-628_fc8ba956-4d3d-4f52-ac8e-89d52a480b48 63187-628 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION OPHTHALMIC 20091105 ANDA ANDA078434 Proficient Rx LP KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 63187-629_1ebf00bd-3beb-43c6-bba4-8fe7471e2f85 63187-629 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 Proficient Rx LP FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 63187-630_7017005f-a772-4e9b-9902-20a9d47b3e7d 63187-630 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120330 ANDA ANDA077159 Proficient Rx LP IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-631_d1f55327-156f-44cd-b0fc-b1a938e8aa73 63187-631 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 19970214 ANDA ANDA064120 Proficient Rx LP POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 63187-632_37e6a157-5d0d-4887-9a26-ed5521fb08e6 63187-632 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET ORAL 20000215 ANDA ANDA040327 Proficient Rx LP ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-633_feee6a01-63f9-42c3-8bd8-ca713a08b36d 63187-633 HUMAN PRESCRIPTION DRUG Celecoxib 200 mg CELECOXIB CAPSULE ORAL 20151124 ANDA ANDA204519 Proficient Rx LP CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-634_9132c2ee-775a-40bf-b3d8-c9531f993f58 63187-634 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Proficient Rx LP SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 63187-635_eee73d4f-0c0e-4104-a66b-3c001994772a 63187-635 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Proficient Rx LP LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63187-636_7522c99e-437c-4cd1-99f5-9f50ef201c26 63187-636 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Proficient Rx LP ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-637_df5aee40-ffa9-4cf3-ab5f-30253f43092b 63187-637 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Proficient Rx LP AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63187-638_1d5d5f27-6565-4e7b-9923-faa3d15cb1c4 63187-638 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20070919 ANDA ANDA077538 Proficient Rx LP FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-639_4842be24-3919-48ae-9302-eb9d3d921224 63187-639 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20140401 ANDA ANDA204165 Proficient Rx LP CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 63187-640_71a916f5-6f82-45bd-98d2-61f9652b0b33 63187-640 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 Proficient Rx LP FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 63187-641_beb0cefb-807b-4cc3-ada2-7a8ed4aa8f2b 63187-641 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Proficient Rx LP GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63187-642_1b5c9889-4dc3-48df-8629-4ac099e2b4c0 63187-642 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20150909 ANDA ANDA201003 Proficient Rx LP RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-643_c529b321-38ed-434f-b76e-06902cdd40dc 63187-643 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150312 ANDA ANDA200562 Proficient Rx LP CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-644_2a8bc721-1404-4cf3-821b-8a7db2021432 63187-644 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20150212 ANDA ANDA202392 Proficient Rx LP RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-645_5e392834-2930-41b3-a9ad-d35d35974038 63187-645 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Proficient Rx LP BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 63187-646_4f90b0cd-9443-4940-8781-1a05e42ccbb8 63187-646 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 20061024 ANDA ANDA076510 Proficient Rx LP DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-647_6bb7d3cc-2b5a-4a48-858e-5421c68b6989 63187-647 HUMAN PRESCRIPTION DRUG Testosterone Cypionate Testosterone Cypionate INJECTION INTRAMUSCULAR 20120501 ANDA ANDA091244 Proficient Rx LP TESTOSTERONE CYPIONATE 200 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 63187-648_601cab21-c211-4c34-be7b-f4fdd97a921a 63187-648 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SUSPENSION AURICULAR (OTIC) 20030317 ANDA ANDA062488 Proficient Rx LP NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-649_3e5c0f26-0b55-4868-b4f7-9c52e802fb44 63187-649 HUMAN OTC DRUG Triple Antibiotic Neomycin and Polymyxin B Sulfates and Bacitracin Zinc OINTMENT TOPICAL 20100106 OTC MONOGRAPH FINAL part333B Proficient Rx LP BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 63187-650_003dbf85-8eb3-4587-944b-62c274b81172 63187-650 HUMAN OTC DRUG Bismatrol Bismuth subsalicylate TABLET, CHEWABLE ORAL 20030103 OTC MONOGRAPH FINAL part335 Proficient Rx LP BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 63187-651_6510a588-f2dc-4a71-aef0-b8fbe8fd615b 63187-651 HUMAN OTC DRUG Bismatrol Bismuth Subsalicylate LIQUID ORAL 20080530 OTC MONOGRAPH FINAL part335 Proficient Rx LP BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 63187-652_9bf81b26-38b4-486c-ae89-222119ce1a4f 63187-652 HUMAN OTC DRUG Multi-Symptom Mapap Cold Formula Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 OTC MONOGRAPH FINAL part341 Proficient Rx LP ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 63187-653_97b09783-7bba-4f7a-b1b3-86ccf12c7ecc 63187-653 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120927 ANDA ANDA202414 Proficient Rx LP IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-654_50a278de-bd16-417c-a741-81bfe0d745f2 63187-654 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE TABLET, DELAYED RELEASE ORAL 20140910 ANDA ANDA202882 Proficient Rx LP PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 63187-655_b58471fe-e2c6-4cc5-9d49-6a3111f6e002 63187-655 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20150831 ANDA ANDA204821 Proficient Rx LP VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-656_957feff4-5005-4eea-bbe2-7232be65b0eb 63187-656 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Proficient Rx LP ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-657_8bdd9b2f-9033-45e0-96d6-696977fcb1e6 63187-657 HUMAN PRESCRIPTION DRUG Dutasteride Dutasteride CAPSULE ORAL 20151120 ANDA ANDA202808 Proficient Rx LP DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 63187-658_e6711f26-a01d-43e8-882a-d58561e4b67f 63187-658 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 Proficient Rx LP HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 63187-659_b292cb9b-7348-4c07-a871-bc091229fdf8 63187-659 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Proficient Rx LP GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63187-660_7c733a30-5002-49e7-a6bd-7737a1d2461e 63187-660 HUMAN OTC DRUG Rugby Capsaicin External Analgesic Capsaicin CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP CAPSAICIN .025 g/100g N 20181231 63187-661_1ed85825-cd03-4b5b-9c9a-946653b5f71a 63187-661 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20090601 NDA NDA014901 Proficient Rx LP TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-662_2d2807a8-19d5-4922-8270-a8885d61e851 63187-662 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20080701 ANDA ANDA076407 Proficient Rx LP OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63187-663_b84ccb27-9c52-43b9-9a46-8f52a571045e 63187-663 HUMAN PRESCRIPTION DRUG levocetirizine dihydrochloride levocetirizine dihydrochloride TABLET ORAL 20141027 ANDA ANDA203646 Proficient Rx LP LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 63187-664_ed9399e2-2be8-4793-99c5-204779c2a471 63187-664 HUMAN PRESCRIPTION DRUG Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide SYRUP ORAL 20150206 ANDA ANDA205292 Proficient Rx LP BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 2; 30; 10 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] N 20181231 63187-665_844c9558-bd34-4d8e-96bb-e022199ccc0d 63187-665 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 Proficient Rx LP ESZOPICLONE 3 mg/1 CIV N 20181231 63187-666_51c342c9-b9c6-467d-8fea-b73d72e3febc 63187-666 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Proficient Rx LP DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-667_240c3ac6-9aab-4185-994e-a0254e3aeb61 63187-667 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Proficient Rx LP GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63187-668_f343f1e0-c163-432c-85cf-6cc2f776bd13 63187-668 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 Proficient Rx LP POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 63187-669_21c9b34c-af88-4c9e-9b6c-32d78d34ba7e 63187-669 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 19940725 ANDA ANDA064063 Proficient Rx LP NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-670_9913ed0c-aaad-45e1-b522-98ad170c2e8a 63187-670 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Proficient Rx LP ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-671_c4d91926-ebb1-46f6-abf9-1421d5c13ff3 63187-671 HUMAN OTC DRUG PlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg ACETAMINOPHEN TABLET ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 Proficient Rx LP ACETAMINOPHEN 500 mg/1 N 20181231 63187-672_00ea3641-18da-4a6f-a779-e16075464d2b 63187-672 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20140414 ANDA ANDA204234 Proficient Rx LP DOXYCYCLINE 100 mg/1 N 20181231 63187-673_76dc85bd-3cde-4940-a99b-663b70bf9f54 63187-673 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20031211 ANDA ANDA076416 Proficient Rx LP TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63187-674_89cf9522-de03-4d63-be66-fd4d385ed184 63187-674 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150407 ANDA ANDA040616 Proficient Rx LP WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 63187-675_4146cfc6-2b02-4731-a0f1-8c445bafea55 63187-675 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071226 ANDA ANDA076549 Proficient Rx LP RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-676_fbf900f6-0c37-4da6-87e0-cb752e11335f 63187-676 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Proficient Rx LP PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-677_1279c031-106f-44a5-9e8a-da37cd9e24bd 63187-677 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20150708 ANDA ANDA202769 Proficient Rx LP DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-679_289c1d5e-902f-47db-85b8-5e1a55ec8684 63187-679 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Proficient Rx LP CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-680_e872ff93-4c60-4535-b0db-91240d008efd 63187-680 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072192 Proficient Rx LP TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63187-681_1d167b24-eb16-48ea-8a97-048cfad6ba62 63187-681 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20151123 ANDA ANDA204019 Proficient Rx LP FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 63187-682_e534b3ac-1110-465f-8692-6ea585996fb6 63187-682 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076410 Proficient Rx LP ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 63187-683_9641cbbb-cf36-4310-b801-026298ae3536 63187-683 HUMAN OTC DRUG Plus Pharma Senna Standardized Senna Concentrate 8.6 mg Sennosides Each SENNOSIDES TABLET, FILM COATED ORAL 20060327 OTC MONOGRAPH NOT FINAL part334 Proficient Rx LP SENNOSIDES 8.6 mg/1 N 20181231 63187-685_504735e2-b13b-41c4-b2ed-5991f53b6fb6 63187-685 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090801 ANDA ANDA077789 Proficient Rx LP CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 63187-686_3c5606a8-87d2-423e-ab33-849b99afb7fc 63187-686 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Proficient Rx LP RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63187-687_c5b39a38-fe64-43db-a15c-5c3e24c783a7 63187-687 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate CREAM TOPICAL 20020901 ANDA ANDA070050 Proficient Rx LP BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-688_b781a162-244d-49b2-8918-031fce0587d7 63187-688 HUMAN OTC DRUG Pedia Relief Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID ORAL 19970105 OTC MONOGRAPH FINAL part341 Proficient Rx LP CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 1; 15; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 63187-689_bc293912-9ae2-459d-9ac5-2bad046f7e1a 63187-689 HUMAN OTC DRUG Cough and Cold Chlorpheniramine maleate, Dextromethorphan HBr TABLET, SUGAR COATED ORAL 20030503 OTC MONOGRAPH FINAL part341 Proficient Rx LP CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 63187-690_92c58053-7ed8-4a3d-a2f7-8e30c4e5a367 63187-690 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20070423 ANDA ANDA077322 Proficient Rx LP ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 63187-691_92c58053-7ed8-4a3d-a2f7-8e30c4e5a367 63187-691 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20070423 ANDA ANDA077322 Proficient Rx LP ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 63187-692_901385e5-7384-4c28-a36a-7dd84c36f5fd 63187-692 HUMAN PRESCRIPTION DRUG MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET, COATED ORAL 20151110 ANDA ANDA203432 Proficient Rx LP MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 63187-693_4feb4b89-2d2f-4a9c-a4f4-5ae3e26281b6 63187-693 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Proficient Rx LP ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-694_1f6ab5e0-8320-4489-bed2-8c90c534e5ae 63187-694 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Proficient Rx LP VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-695_29e83667-8d4a-49b7-9182-653cbfb2dee7 63187-695 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Proficient Rx LP SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 63187-696_d63b64dd-b420-4283-9bac-92ba43c9f429 63187-696 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Proficient Rx LP TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-697_11970e27-0c47-46f5-929a-1445841cd300 63187-697 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 NDA NDA018851 Proficient Rx LP INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-698_5a5747ea-cded-49ed-8807-dd3e2a1159e0 63187-698 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Proficient Rx LP GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63187-699_0a3c1944-c782-423a-8935-40d69a88390a 63187-699 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20071212 ANDA ANDA065248 Proficient Rx LP CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 63187-700_c63f56ec-cd8d-4f84-8d57-cdc0f7acfa9d 63187-700 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 Proficient Rx LP ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 63187-701_d9c10cc7-1a5c-43f2-87a8-5390a88d448a 63187-701 HUMAN OTC DRUG Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20090317 OTC MONOGRAPH FINAL part341 Proficient Rx LP OXYMETAZOLINE HYDROCHLORIDE 5 g/100mL N 20181231 63187-702_41c86c02-68c0-4db5-af1a-941b0d2ffe11 63187-702 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Proficient Rx LP DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-703_5ef15e1c-66dc-4858-8552-d83e42c3883e 63187-703 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 19930128 ANDA ANDA064022 Proficient Rx LP NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 63187-705_45c3c2a1-6a89-471e-b6d4-5a4cd73b987a 63187-705 HUMAN PRESCRIPTION DRUG Trezix acetaminophen, caffeine, dihydrocodeine bitartrate CAPSULE ORAL 20141201 ANDA ANDA204785 Proficient Rx LP ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 320.5; 30; 16 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 63187-706_12266b6d-8a6d-425b-88f9-8c6b4d5b1850 63187-706 HUMAN PRESCRIPTION DRUG Nalfon fenoprofen calcium CAPSULE ORAL 20120827 NDA NDA017604 Proficient Rx LP FENOPROFEN CALCIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-707_a8402a0f-5bc4-4e97-9e62-1fbae9e6b30d 63187-707 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076410 Proficient Rx LP ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 63187-708_5b1f6677-9473-467f-9fb6-efadbd8828e8 63187-708 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20150819 ANDA ANDA203835 Proficient Rx LP LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-709_69ed01b7-a94e-4946-a044-a9f8c37616ec 63187-709 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Proficient Rx LP ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63187-710_b198b34c-861a-4b52-b4df-8c48b807520a 63187-710 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 Proficient Rx LP ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-711_faf2403b-98f0-405d-9748-204cc2d4f6a3 63187-711 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131216 ANDA ANDA079067 Proficient Rx LP METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 63187-712_f3ba6c30-ada3-4a57-9ff8-30558202b9aa 63187-712 HUMAN PRESCRIPTION DRUG doxycycline doxycycline CAPSULE ORAL 20160314 ANDA ANDA205115 Proficient Rx LP DOXYCYCLINE 100 mg/1 N 20181231 63187-713_e57451fd-aba5-47d6-9892-ffe2a6021b6f 63187-713 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090501 ANDA ANDA077415 Proficient Rx LP BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63187-714_9eeb2aef-3eb1-4583-8180-d480deb3651c 63187-714 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20101231 ANDA ANDA090066 Proficient Rx LP DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-715_70921f99-1f25-4a8c-8269-6d5d26be7a63 63187-715 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Proficient Rx LP NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63187-716_1a1f3657-8482-421e-a283-8c43eee47133 63187-716 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140613 ANDA ANDA202045 Proficient Rx LP DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-717_3c7783a7-2b28-4968-b766-0a49dc70ce6d 63187-717 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 20071212 OTC MONOGRAPH NOT FINAL part343 Proficient Rx LP ASPIRIN 81 mg/1 N 20181231 63187-718_150b84c1-59dc-41e3-9a6b-6c979fcc5720 63187-718 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20090909 ANDA ANDA078581 Proficient Rx LP TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-719_9115147f-57c7-4d08-9514-377ec96e9e95 63187-719 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20160309 ANDA ANDA202677 Proficient Rx LP OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63187-720_407b62b9-5b32-4bac-a2b0-7df499279248 63187-720 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Proficient Rx LP DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-721_5f34d2ac-bdee-4db9-b1c6-53b51f26800c 63187-721 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040778 Proficient Rx LP OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63187-722_4067b6c7-2a99-4c41-82ec-b47506603c3c 63187-722 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150523 ANDA ANDA075994 Proficient Rx LP LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-723_2d0f9d8e-a6a2-4344-9f4e-a3dc015852b4 63187-723 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 Proficient Rx LP FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63187-725_2e905c1f-9022-4c07-b240-39ff7d6fb12e 63187-725 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20150813 ANDA ANDA203818 Proficient Rx LP DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-726_13770e60-117c-4814-93bb-9bc41a042a20 63187-726 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Proficient Rx LP BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63187-727_a6e7d8a7-f969-4a21-ac28-93c77ed1fa63 63187-727 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Proficient Rx LP LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-728_cbc1dfe2-972a-4aea-a339-52e48194cee1 63187-728 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20150205 ANDA ANDA077285 Proficient Rx LP BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63187-729_586a5911-e30b-40ed-a056-9e67920ca951 63187-729 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Proficient Rx LP AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-731_28b97a67-44d8-4db0-b166-60f096d409f5 63187-731 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20061023 ANDA ANDA076939 Proficient Rx LP PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-732_28b97a67-44d8-4db0-b166-60f096d409f5 63187-732 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20061023 ANDA ANDA076939 Proficient Rx LP PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-733_af037a9d-c36e-40db-9e23-0ba6102ca495 63187-733 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 Proficient Rx LP HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63187-734_a2089612-de4b-4d78-b311-fa2524bd37f6 63187-734 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION OPHTHALMIC 20141215 ANDA ANDA078559 Proficient Rx LP OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63187-735_22a8cc15-17fb-4c4e-8d2a-de5755ed6031 63187-735 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Proficient Rx LP DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-736_e2fef939-2f4a-46ae-8177-073f5e8f57f5 63187-736 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20030501 ANDA ANDA076004 Proficient Rx LP ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-737_ada35ec2-8472-411a-8e7c-ff1a0df94ab5 63187-737 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202254 Proficient Rx LP IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-738_bf8568fe-b2b4-45dc-892e-92cfe37e6f87 63187-738 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19910731 ANDA ANDA063083 Proficient Rx LP CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63187-739_677adf55-b6b0-418d-a6ec-0dcedeb53847 63187-739 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Proficient Rx LP FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63187-740_7e1d0762-5e03-42b8-b409-3191592f3c10 63187-740 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Proficient Rx LP DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 63187-741_7e570b07-2a9e-49bf-b224-1e34f6eda3ab 63187-741 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Proficient Rx LP ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 63187-742_abac11e6-7ce1-491c-9ac3-61f3df54c4a4 63187-742 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Proficient Rx LP DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 63187-743_abac11e6-7ce1-491c-9ac3-61f3df54c4a4 63187-743 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Proficient Rx LP DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 63187-744_a915f81c-370a-40cf-9a60-371cdf690164 63187-744 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Proficient Rx LP LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 63187-745_d04b9e18-cf5f-4a67-9f2e-393af6077768 63187-745 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150407 ANDA ANDA040616 Proficient Rx LP WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 63187-746_f428d7d7-dbb1-4112-a651-5e0df7227cb8 63187-746 HUMAN PRESCRIPTION DRUG PIOGLITAZONEHYDROCHLORIDE PIOGLITAZONEHYDROCHLORIDE TABLET ORAL 20130213 ANDA ANDA091298 Proficient Rx LP PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 63187-747_81a8b199-524e-40e4-898a-c485cbf8bc22 63187-747 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 20130801 NDA AUTHORIZED GENERIC NDA019048 Proficient Rx LP DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-748_fb84b86e-5f1f-4c17-8b69-ff695c5faf55 63187-748 HUMAN PRESCRIPTION DRUG Norethindrone Norethindrone TABLET ORAL 20101103 ANDA ANDA091209 Proficient Rx LP NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 63187-749_e3f0c249-8085-4979-823a-820e233a284f 63187-749 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 19900930 ANDA ANDA071655 Proficient Rx LP OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 63187-750_d04b9e18-cf5f-4a67-9f2e-393af6077768 63187-750 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150512 ANDA ANDA040616 Proficient Rx LP WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 63187-751_54014b67-3163-4c8f-b93a-229cd231ca6b 63187-751 HUMAN PRESCRIPTION DRUG MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET, CHEWABLE ORAL 20151110 ANDA ANDA203328 Proficient Rx LP MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 63187-752_cc3a1258-aafb-48cf-86f7-fcf59e0c6cdd 63187-752 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Proficient Rx LP VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-753_a7447467-79e0-436e-a273-d1ddd06169cf 63187-753 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium GEL TOPICAL 20160701 NDA AUTHORIZED GENERIC NDA022122 Proficient Rx LP DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-754_d19ff955-1778-43c7-a111-476d740dc9d9 63187-754 HUMAN PRESCRIPTION DRUG TRI-LO-MARZIA norgestimate and ethinyl estradiol KIT 20160118 ANDA ANDA200541 Proficient Rx LP N 20181231 63187-755_e3499822-3e3f-43a3-b48d-4436f6cad8a3 63187-755 HUMAN OTC DRUG Meclizine HCl 25 mg Meclizine Hydrochloride TABLET, CHEWABLE ORAL 20151015 OTC MONOGRAPH FINAL part336 Proficient Rx LP MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 63187-756_e73087af-d485-42e2-8821-51d906e3eeaf 63187-756 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Proficient Rx LP PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-757_5c83ff4e-271c-4b66-903d-21c8455868c1 63187-757 HUMAN PRESCRIPTION DRUG Irbesartan IRBESARTAN TABLET ORAL 20120927 ANDA ANDA203071 Proficient Rx LP IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-758_57ac12ed-27f0-4f5c-96ae-a7433714b429 63187-758 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Proficient Rx LP TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-759_b387ba49-fd3f-4488-86e8-9b81e85ab232 63187-759 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Proficient Rx LP NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63187-760_6ec96fe8-2538-4f0f-8c70-37f8e3615338 63187-760 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 Proficient Rx LP FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 63187-761_291099f3-2260-4fb2-9094-e0351be6d650 63187-761 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Proficient Rx LP DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-762_968f4686-23b4-4b4a-9fe5-2eee7a370010 63187-762 HUMAN PRESCRIPTION DRUG Diclofenac sodium Diclofenac GEL TOPICAL 20160321 ANDA ANDA208077 Proficient Rx LP DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-763_1020d3cd-c7b8-405a-8538-a16bf10e3ea4 63187-763 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 Proficient Rx LP HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63187-764_2098faaa-7f60-4640-8c37-19456ebba653 63187-764 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20061213 ANDA ANDA064163 Proficient Rx LP GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 63187-765_2b53ab6a-5770-4fd7-9aa1-f4273d4bdaeb 63187-765 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Proficient Rx LP LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-766_ec9cbb38-1582-492f-a526-4b3675c55b14 63187-766 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081126 ANDA ANDA077715 Proficient Rx LP BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63187-767_aacb9de3-8be3-4fa5-be3f-44402b69b8df 63187-767 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Proficient Rx LP SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-768_8e39601f-ada5-4ef7-9b53-083cffec79ec 63187-768 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 Proficient Rx LP METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-769_a24255a3-88b1-47ef-90fc-51619a1c5a63 63187-769 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951226 ANDA ANDA074185 Proficient Rx LP DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63187-770_5db8df09-4e06-4681-918d-29ca6b50b3ec 63187-770 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20050113 ANDA ANDA065089 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 63187-771_ad93708c-94cd-4694-a94f-8755dc979741 63187-771 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20090102 OTC MONOGRAPH FINAL part341 Proficient Rx LP DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63187-772_7dbd38ab-7965-463f-9f8e-70efa8e071fb 63187-772 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20160708 ANDA ANDA077836 Proficient Rx LP GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 63187-773_2917ba32-3355-4d64-966a-8518e6fafdbe 63187-773 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Proficient Rx LP TOPIRAMATE 25 meq/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-774_4f08caf2-a57c-4146-9289-532711bbdbcd 63187-774 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 Proficient Rx LP KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63187-775_06862c94-103d-4b12-8a74-abf52cb42389 63187-775 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 Proficient Rx LP LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-776_e3ad8bf7-2ac6-46c7-8dd0-5430d6d50d92 63187-776 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Proficient Rx LP VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63187-777_2f27e304-7a96-47b6-8ef1-8a649c25abcf 63187-777 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION/ DROPS OPHTHALMIC 20091207 ANDA ANDA076109 Proficient Rx LP KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 63187-778_34743e0d-99bb-42c3-b7fc-14649a5adf32 63187-778 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120412 ANDA ANDA201013 Proficient Rx LP HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 63187-779_3ba957ea-28ed-4a61-a318-98064ea4944d 63187-779 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20130301 ANDA ANDA201991 Proficient Rx LP METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63187-780_eddec313-910c-4bf1-9095-2153db53bc6e 63187-780 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Proficient Rx LP LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-781_97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5 63187-781 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20130411 ANDA ANDA202717 Proficient Rx LP MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 63187-782_0df74ba1-1aa6-467c-92e7-6b017c7c6bce 63187-782 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Proficient Rx LP SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 63187-783_ced6d26e-8c54-4808-88b6-446344f4acd0 63187-783 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20101020 ANDA ANDA078925 Proficient Rx LP AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63187-784_bd8b7fcd-04f4-4d1c-aa27-743aaf4c2876 63187-784 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 Proficient Rx LP DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 63187-785_f6baeb5c-ca9c-4730-aeb8-8f8732e8ca3a 63187-785 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20160722 ANDA ANDA202764 Proficient Rx LP GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63187-786_112441ff-167c-462a-aa80-7e0a1a4eff6c 63187-786 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20150601 ANDA ANDA205085 Proficient Rx LP CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-787_1fdf446d-cd4e-491f-ac8b-c35c74fb2c91 63187-787 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Proficient Rx LP OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-788_59583d5a-3d1c-4407-8222-769f7290e5e6 63187-788 HUMAN PRESCRIPTION DRUG RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA078964 Proficient Rx LP RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 63187-789_60a69030-6b19-4114-9939-7b7b9adfadf3 63187-789 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET ORAL 20121108 ANDA ANDA202025 Proficient Rx LP SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 63187-790_600ca175-be2b-4c43-b119-133ae21a5601 63187-790 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Proficient Rx LP FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63187-791_20107264-e533-4de9-9a37-59fde7981c92 63187-791 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION/ DROPS TRANSDERMAL 20150820 ANDA ANDA204132 Proficient Rx LP DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-792_11543e95-6f95-4ec7-8bce-48c96eb5508c 63187-792 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20140813 ANDA ANDA077137 Proficient Rx LP TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 63187-793_449b273a-936a-4c49-b0c8-d0daa47733ae 63187-793 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Proficient Rx LP ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-794_c0dc7f87-355c-4357-b99d-f03693d350a7 63187-794 HUMAN OTC DRUG Good Sense Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20140331 ANDA ANDA074661 Proficient Rx LP NAPROXEN SODIUM 220 mg/1 N 20181231 63187-795_787a683a-091c-4908-a643-ecbc8fd467eb 63187-795 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Proficient Rx LP SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-796_8e9e0c26-399c-48ec-b32d-cfb896b870f4 63187-796 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 Proficient Rx LP ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-797_1042b91c-715c-4e90-b9cc-d91a17f9f7cb 63187-797 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Proficient Rx LP SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63187-798_c5b1ef5e-9681-426a-abf6-60d9c28d92a0 63187-798 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Proficient Rx LP NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63187-799_a7b12862-1c9f-4712-93e6-a859b24728c2 63187-799 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070409 ANDA ANDA040597 Proficient Rx LP BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 63187-800_b3c48b3c-fab7-4ea4-93b0-b108979e9da3 63187-800 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20110610 ANDA ANDA203068 Proficient Rx LP PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 63187-801_7d6752ce-7a56-4b04-ab15-cbd40aa5cc94 63187-801 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 Proficient Rx LP TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-802_6cc22d98-754c-4f95-973f-c30055a10d2f 63187-802 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20160526 ANDA ANDA040232 Proficient Rx LP METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-803_01b30abb-db63-4257-9fe2-9107bb0bd69c 63187-803 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20020315 ANDA ANDA065064 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 63187-804_517824b1-11be-40a9-9066-d1a6a32a2938 63187-804 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Proficient Rx LP SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 63187-805_f0f61a89-700d-481d-9255-6f9a9afa7025 63187-805 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Proficient Rx LP OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-806_ab8c172b-c369-4372-95f9-dd1a28b3982b 63187-806 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20060222 ANDA ANDA076504 Proficient Rx LP FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-807_91f43834-00d8-49dc-88d1-bcdf13febd16 63187-807 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Proficient Rx LP PREDNISONE 20 mg/1 N 20181231 63187-808_4b298291-4251-4af8-a436-58a3443a7978 63187-808 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 Proficient Rx LP LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-809_2f9fc7a0-163a-4a05-84a7-7999a41ecb1f 63187-809 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Proficient Rx LP NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63187-810_2ef99c3d-866a-438b-a340-8beba8d4c457 63187-810 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Proficient Rx LP GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63187-811_d5398166-5698-4ee5-bd41-3c24e4445b53 63187-811 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Proficient Rx LP GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63187-812_4f7c5aaa-dadc-41c2-b751-563c96f2a153 63187-812 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-813_2538995d-2df6-4c87-978a-5513c670b60f 63187-813 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20140103 ANDA ANDA203814 Proficient Rx LP SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 63187-814_f9e27117-db98-48bc-b7bc-fc98c9b719cf 63187-814 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Proficient Rx LP LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-815_75b50751-5237-4e3e-b7ee-1605c0602f3b 63187-815 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170105 ANDA ANDA202800 Proficient Rx LP ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 63187-816_afd766bc-2a42-40b5-b33f-1a8b5ce2622e 63187-816 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Proficient Rx LP RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-817_1582ba77-a4e3-464f-876b-28cc7e41e8f1 63187-817 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Proficient Rx LP ESZOPICLONE 1 mg/1 CIV N 20181231 63187-818_702b6577-e06c-4afe-a058-b1e8bb7e3cf5 63187-818 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 Proficient Rx LP DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 63187-819_9e2d9c1e-a1de-491d-8f64-34ae60419611 63187-819 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20150217 ANDA ANDA077285 Proficient Rx LP BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63187-820_2d99b4fd-49b3-403d-96a4-0cceda85a95c 63187-820 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Proficient Rx LP OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-821_350c6fc9-9774-4d49-9242-19e96944f83b 63187-821 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Proficient Rx LP LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-822_c1446ba4-82e8-4f5e-9f1e-c8a75dd536c7 63187-822 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19951130 ANDA ANDA074394 Proficient Rx LP DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-823_df97ea5a-51df-453b-b1b4-edc74c718ee7 63187-823 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20161201 ANDA ANDA201972 Proficient Rx LP OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63187-824_55beae6e-43e7-4142-8177-a5c8f600f82a 63187-824 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20140828 ANDA ANDA201278 Proficient Rx LP OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63187-825_3e4e69f6-b8a6-462d-a7ec-4cd6636512d0 63187-825 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 Proficient Rx LP LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-826_4655e0ea-f7d5-4f7c-bf7b-266337bc05b8 63187-826 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 Proficient Rx LP AMOXICILLIN; CLAVULANIC ACID 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 63187-827_b1836855-d32f-4fe5-aab1-bafea91cc3c9 63187-827 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 Proficient Rx LP METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 63187-828_5ad413ed-a21b-4f8b-9322-8fbb813b14d3 63187-828 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Proficient Rx LP OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63187-829_0670d289-d763-4df4-82bd-da0fbbf09900 63187-829 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 Proficient Rx LP PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63187-830_c0319153-3e35-4a84-aa63-935b1e0047d8 63187-830 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 Proficient Rx LP LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63187-831_dce2e97a-cd92-46b9-9444-91739bdcd526 63187-831 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE TABLET, DELAYED RELEASE ORAL 20140910 ANDA ANDA202882 Proficient Rx LP PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 63187-832_c6328ed5-a3d3-4948-94be-b226271d0311 63187-832 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Proficient Rx LP VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63187-833_95149cfb-1a71-42b7-b50d-9a2e94334339 63187-833 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150109 ANDA ANDA202801 Proficient Rx LP LEVOFLOXACIN 750 mg/1 N 20181231 63187-835_be963e80-e298-49a0-a52f-3d4dcded7c8c 63187-835 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 Proficient Rx LP CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 63187-836_2996f29c-880f-425a-9fdf-d2b3b5f62308 63187-836 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20150813 ANDA ANDA086724 Proficient Rx LP LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 63187-837_a7dc4321-331d-49af-976c-cfd69d0055d9 63187-837 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole TABLET, DELAYED RELEASE ORAL 20160620 ANDA ANDA205119 Proficient Rx LP PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 63187-838_7f8a996d-cac2-44ee-8023-18016496eadb 63187-838 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141006 ANDA ANDA040148 Proficient Rx LP HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 63187-839_a9d0b2dd-4407-47e1-adf3-830ddda0d491 63187-839 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Proficient Rx LP PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-840_c1044563-2bd2-4f43-a951-25d083b1c679 63187-840 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20121128 ANDA ANDA090168 Proficient Rx LP BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 63187-841_5c2ae130-8e84-4c3f-b190-82691312fcbd 63187-841 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20130201 ANDA ANDA203253 Proficient Rx LP SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 63187-842_e5c28155-a7a5-4d1e-aae5-99408b5f457c 63187-842 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071209 Proficient Rx LP HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 63187-843_d301b0cf-1492-4be9-83a0-1b64c8fa3b72 63187-843 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Proficient Rx LP ESZOPICLONE 3 mg/1 CIV N 20181231 63187-844_7772a4c2-1fb1-412b-9e3b-ef3d693517a2 63187-844 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120423 ANDA ANDA090798 Proficient Rx LP OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 63187-845_de5dd8b7-ce8c-4af5-84dc-fa922e87059e 63187-845 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Proficient Rx LP DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 63187-846_4d248715-f6ea-47fb-8c75-77c70022f01e 63187-846 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071136 Proficient Rx LP DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-848_ec45f0d8-cab8-4822-895b-17bb443a4f98 63187-848 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Proficient Rx LP GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63187-849_19cb23bd-cc6d-45fc-a1fc-b4130ea460a6 63187-849 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 Proficient Rx LP VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63187-850_d67e4b17-7d44-4d72-9150-420d98cc6db3 63187-850 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20150402 ANDA ANDA065062 Proficient Rx LP MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 63187-851_5685c3f7-6139-4d3a-8757-240d8498df69 63187-851 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Proficient Rx LP LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63187-852_41d3877f-bc53-4ca5-a4bc-eb3a4bf7f374 63187-852 HUMAN PRESCRIPTION DRUG indomethacin indomethacin CAPSULE ORAL 20160721 ANDA ANDA090403 Proficient Rx LP INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-853_4901f25c-96a7-4fe3-b7d3-e1cebeabd803 63187-853 HUMAN OTC DRUG good sense tussin dm Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 19910918 OTC MONOGRAPH FINAL part341 Proficient Rx LP DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 63187-854_389c415f-5cfb-4ae3-b596-2697af10a166 63187-854 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20071226 ANDA ANDA076549 Proficient Rx LP RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-855_d0889a7c-a60a-4d83-86e2-01da833a494e 63187-855 HUMAN PRESCRIPTION DRUG Ranitidine Immediate release Ranitidine TABLET ORAL 20160829 ANDA ANDA205512 Proficient Rx LP RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63187-856_fcecd55a-afee-4998-b13d-ff49c83f7119 63187-856 HUMAN OTC DRUG Good Sense ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20041109 ANDA ANDA076359 Proficient Rx LP IBUPROFEN 100 mg/1 N 20181231 63187-857_3a7248ca-2855-433e-aabc-42f0bb0db118 63187-857 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20040923 ANDA ANDA065162 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 63187-858_7cecdf97-6685-4cf5-ad88-3442fb83d810 63187-858 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SOLUTION ORAL 20090313 ANDA ANDA040891 Proficient Rx LP PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63187-859_00179766-980b-44b0-99d3-1fee2bb27e37 63187-859 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Proficient Rx LP SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-860_3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 63187-860 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Proficient Rx LP ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-861_caf9c845-63eb-40bd-8261-0582abdf705a 63187-861 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20130201 ANDA ANDA203253 Proficient Rx LP SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 63187-862_facfc337-3447-4052-a9aa-8aa55282a3e3 63187-862 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101206 NDA AUTHORIZED GENERIC NDA021774 Proficient Rx LP ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 63187-863_870ab7fe-fff9-4348-b900-213c1cf05f8e 63187-863 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20131108 ANDA ANDA091643 Proficient Rx LP FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 63187-864_3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 63187-864 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Proficient Rx LP ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-865_3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 63187-865 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Proficient Rx LP ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-866_6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 63187-866 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 Proficient Rx LP DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 63187-867_be6962cf-58a8-41c8-b209-5eddb5b94e46 63187-867 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071135 Proficient Rx LP DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 63187-868_68a35514-dee5-4a29-a16f-ca1fb4556d38 63187-868 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20061227 ANDA ANDA077657 Proficient Rx LP LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-869_9e8e4b93-31ef-41eb-a1ed-3d351ae6ca72 63187-869 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160818 ANDA ANDA079166 Proficient Rx LP ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-870_55edd3f6-636f-478d-886c-4ef1420e33c9 63187-870 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20060928 ANDA ANDA086414 Proficient Rx LP TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63187-871_bce7e65a-148f-4ccd-9305-bc7331dbcca4 63187-871 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20090921 ANDA ANDA078635 Proficient Rx LP BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63187-872_3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 63187-872 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Proficient Rx LP ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-874_42e4f9dd-6032-4257-bd0f-8e9b71027f03 63187-874 HUMAN PRESCRIPTION DRUG Quinapril Quinapril Hydrochloride TABLET, FILM COATED ORAL 20130429 ANDA ANDA202725 Proficient Rx LP QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-875_4b6418a8-600f-470e-adf1-56207bb25c38 63187-875 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Proficient Rx LP NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63187-876_a469689a-e64e-4117-b94a-c8b730abda1a 63187-876 HUMAN PRESCRIPTION DRUG Levalbuterol tartrate HFA inhalation levalbuterol tartrate AEROSOL, METERED ORAL 20161001 NDA AUTHORIZED GENERIC NDA021730 Proficient Rx LP LEVALBUTEROL TARTRATE 45 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 63187-877_5a95ddcb-e312-483f-bb10-79cbb8ac408e 63187-877 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 Proficient Rx LP PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63187-878_fbb1bda3-f733-4404-9c9d-46c418700c03 63187-878 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Proficient Rx LP FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 63187-879_e74b00fc-8743-4e9d-8a83-aab8e531b3ba 63187-879 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 Proficient Rx LP ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 63187-880_7f75de78-2228-48e0-8405-bf631ca431ab 63187-880 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065387 Proficient Rx LP AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63187-881_ee0f16a0-0f92-49f4-9199-6943285c51c5 63187-881 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021127 ANDA ANDA065117 Proficient Rx LP AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 63187-882_f1e527a7-649d-46dd-87fc-28930b03124b 63187-882 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH NOT FINAL part343 Proficient Rx LP ASPIRIN 81 mg/1 N 20181231 63187-883_57eebea5-28b6-44a3-888b-76950f6038f4 63187-883 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080423 ANDA ANDA065392 Proficient Rx LP CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 63187-884_6fe3965f-0dd8-4bae-9771-de25074cb1b0 63187-884 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Proficient Rx LP NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 63187-885_5e619dfa-4401-45bb-83c6-aaaa59203e5e 63187-885 HUMAN OTC DRUG Antifungal miconazole nitrate CREAM TOPICAL 20070501 OTC MONOGRAPH FINAL part333C Proficient Rx LP MICONAZOLE NITRATE 20 mg/g N 20181231 63187-888_d65c9a1e-f2f4-46d2-9b28-ba0e5c67e542 63187-888 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 Proficient Rx LP CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-889_411e6e51-b435-4f86-b39f-3377f009b0e9 63187-889 HUMAN PRESCRIPTION DRUG Aviane Levonorgestrel and Ethinyl Estradiol KIT 20010402 ANDA ANDA075796 Proficient Rx LP N 20181231 63187-890_253c6b2e-2c93-4ee7-94a6-fd063c569c1f 63187-890 HUMAN PRESCRIPTION DRUG Junel Fe 1.5/30 norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20030918 ANDA ANDA076064 Proficient Rx LP N 20181231 63187-891_15e951c3-669d-4db0-8b7c-22c63b3e9af4 63187-891 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20061212 ANDA ANDA040621 Proficient Rx LP PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 63187-892_1ebb45e5-4541-4c95-abe1-661ef763a610 63187-892 HUMAN OTC DRUG Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOL GEL TOPICAL 20170722 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM 40; 10 mg/mL; mg/mL N 20181231 63187-893_cd24da78-fd90-4a9c-8e5f-f7fc56ec0fc9 63187-893 HUMAN OTC DRUG GoodSense Artifical Tears Polyvinyl alcohol, and Povidone SOLUTION/ DROPS OPHTHALMIC 20160404 OTC MONOGRAPH FINAL part349 Proficient Rx LP POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE, UNSPECIFIED .05; .06 g/mL; g/mL N 20181231 63187-895_e1756186-6b8c-4965-bfa7-9d5fad3421ab 63187-895 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20030201 UNAPPROVED DRUG OTHER Proficient Rx LP PHENOBARBITAL 32.4 mg/1 CIV N 20181231 63187-896_0f2dbf17-bce0-4e09-8c22-898d93be80da 63187-896 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA200405 Proficient Rx LP MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 63187-897_812582ce-fc7e-44b1-a428-7faa3701c1b8 63187-897 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060317 ANDA ANDA077634 Proficient Rx LP ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63187-898_0973f33c-c2b7-4735-a4f9-87ee02bc051a 63187-898 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 19970819 ANDA ANDA085588 Proficient Rx LP PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 63187-900_f871dfa7-219f-4704-8e4d-215caeb7408d 63187-900 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET ORAL 19930630 NDA AUTHORIZED GENERIC NDA020215 Proficient Rx LP ISOSORBIDE MONONITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 63187-901_63f388e0-9f3d-4902-990c-9a105aa098ad 63187-901 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Proficient Rx LP HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 63187-902_ac497300-eb1e-4021-b504-89f19e1eb0f3 63187-902 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC 19960131 ANDA ANDA064096 Proficient Rx LP TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 63187-904_69eb15e9-c33e-40a3-82d8-497dad13068d 63187-904 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 Proficient Rx LP BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 63187-905_189ad040-07e9-42a5-854c-67633367da74 63187-905 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20111212 ANDA ANDA201407 Proficient Rx LP TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-906_313225d7-f947-40b3-96d7-289aad300a4a 63187-906 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Proficient Rx LP BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63187-907_a34d3c72-ce91-47c7-86a1-f32caaed2c47 63187-907 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160804 ANDA ANDA205519 Proficient Rx LP ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63187-908_92048836-e692-4ce1-93f4-88b00acabcde 63187-908 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 Proficient Rx LP FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63187-909_92c4d589-533b-4fe4-833f-dd68cc1f7e66 63187-909 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Proficient Rx LP GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63187-910_5b7b4721-e6fa-4586-ac40-091ad363ee85 63187-910 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130401 ANDA ANDA091283 Proficient Rx LP TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63187-911_4e1927bd-378d-45dc-8b18-3dd57ccd2cb6 63187-911 HUMAN PRESCRIPTION DRUG Sprintec Norgestimate and Ethinyl Estradiol KIT 20020926 ANDA ANDA075804 Proficient Rx LP N 20181231 63187-913_b734e9d6-95c3-47ab-a907-723183ac971c 63187-913 HUMAN OTC DRUG Aspir Low Aspirin TABLET ORAL 20110524 OTC MONOGRAPH FINAL part343 Proficient Rx LP ASPIRIN 81 mg/1 N 20181231 63187-914_410aa0a5-43cf-455c-b51d-7dfbc24eee32 63187-914 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Proficient Rx LP AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63187-915_33bdfe96-1b7a-4859-b1c9-ef94b8bb7a2a 63187-915 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Proficient Rx LP RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63187-916_447efe78-3696-481c-bbae-23199a39ec94 63187-916 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Proficient Rx LP ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63187-917_5df651b0-68df-42e7-8b8c-a7cbe5444714 63187-917 HUMAN OTC DRUG Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOL PATCH TOPICAL 20170729 OTC MONOGRAPH NOT FINAL part348 Proficient Rx LP LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM 40; 10 mg/g; mg/g N 20181231 63187-918_33710c3c-6f17-457a-8665-04c23bca8b75 63187-918 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160523 ANDA ANDA091617 Proficient Rx LP LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63187-919_dc35c263-831b-4d57-9834-07363972648e 63187-919 HUMAN PRESCRIPTION DRUG FAMCICLOVIR Famciclovir TABLET ORAL 20110321 ANDA ANDA078278 Proficient Rx LP FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63187-920_dc35c263-831b-4d57-9834-07363972648e 63187-920 HUMAN PRESCRIPTION DRUG FAMCICLOVIR Famciclovir TABLET ORAL 20110321 ANDA ANDA078278 Proficient Rx LP FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63187-921_3b147968-c6a8-4725-89b6-2eb443900e8f 63187-921 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET, FILM COATED ORAL 20150916 ANDA ANDA204507 Proficient Rx LP FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 63187-922_a06f67f6-141e-4879-8f87-c0422f4bfa81 63187-922 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20150213 ANDA ANDA203027 Proficient Rx LP LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 63187-923_258db60a-d33d-4da2-ad16-927f6b26c58d 63187-923 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20170801 ANDA ANDA078722 Proficient Rx LP CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63187-924_90290910-11c8-4b33-b601-90d83b556cca 63187-924 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Proficient Rx LP LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63187-925_08bc9790-34b2-42d5-934d-3731b8005019 63187-925 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 Proficient Rx LP LEVOFLOXACIN 250 mg/1 N 20181231 63187-926_b8f797fb-979c-4eab-a3a6-ad4edcb9ff07 63187-926 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Proficient Rx LP PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 63187-927_8526c68d-221c-4822-9532-1d7868cff35e 63187-927 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 Proficient Rx LP PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-928_9fb78c06-e527-4596-884c-fcf882927a33 63187-928 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040627 Proficient Rx LP BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 63187-929_ded77a84-e6d1-4471-ac6e-a05a0955daa5 63187-929 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Proficient Rx LP VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63187-930_1b79a7d8-a8f4-4525-8b94-3e317fc5a717 63187-930 HUMAN PRESCRIPTION DRUG Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide SYRUP ORAL 20160921 ANDA ANDA203375 Proficient Rx LP BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 2; 30; 10 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] N 20181231 63187-931_fe09fab6-b9e3-469c-9a38-bcc343dcc899 63187-931 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Proficient Rx LP SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63187-932_660f635c-23e4-4b14-b03d-48507da9afb7 63187-932 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA078317 Proficient Rx LP CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20191231 63187-933_7a2219a8-8aaf-44ad-9808-b67923df361a 63187-933 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20120913 ANDA ANDA200243 Proficient Rx LP BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 63187-934_23108c0c-72e9-4353-bd1b-916791b16250 63187-934 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE OINTMENT TOPICAL 20161115 ANDA ANDA086724 Proficient Rx LP LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 63187-935_abe9b43f-a80b-414d-9875-3bd0f7e14ea5 63187-935 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Proficient Rx LP LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 63187-936_1d95ea87-5f14-44f2-ac8c-5b1b6b7e996c 63187-936 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20160429 ANDA ANDA204446 Proficient Rx LP DOXYCYCLINE 100 mg/1 N 20181231 63187-937_8c5247a4-6388-44f4-8a47-3de5e7c5b169 63187-937 HUMAN PRESCRIPTION DRUG Flurbiprofen Sodium Flurbiprofen Sodium SOLUTION/ DROPS OPHTHALMIC 19950104 ANDA ANDA074447 Proficient Rx LP FLURBIPROFEN SODIUM .3 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63187-938_a03aa46f-9eb5-4cf4-addf-745d94af8261 63187-938 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Proficient Rx LP PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 63187-939_c832ef16-a06e-4e47-9df3-ab33bdfa6e56 63187-939 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20170707 ANDA ANDA086727 Proficient Rx LP DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20191231 63187-940_ba12f441-6ace-47d8-9ba5-4408756ac17e 63187-940 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160209 NDA AUTHORIZED GENERIC NDA021656 Proficient Rx LP FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20191231 63187-941_55a19ff1-f8c1-4cf0-8711-9bfa32756de9 63187-941 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Proficient Rx LP CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 63187-942_5efbabf3-4b27-4196-9800-8163e4325095 63187-942 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Proficient Rx LP DOXYCYCLINE HYCLATE 100 mg/1 N 20191231 63187-943_a06ee3c1-bd0d-4dda-a453-1655eebffdae 63187-943 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160520 ANDA ANDA201662 Proficient Rx LP VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 63187-944_7a5f9416-a11d-45fb-bc1a-bd2991d1c10e 63187-944 HUMAN OTC DRUG ACETAMINOPHEN 80 MG FRUIT CHEW ACETAMINOPHEN TABLET ORAL 20151101 OTC MONOGRAPH NOT FINAL part343 Proficient Rx LP ACETAMINOPHEN 80 mg/1 N 20191231 63187-945_deb0e8ee-d6cc-4660-826d-0655d3a6500c 63187-945 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20170601 ANDA ANDA204237 Proficient Rx LP RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 63187-947_2a2fbc1b-6430-485b-b581-10fbfca0af88 63187-947 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride Diethylpropion Hydrochloride TABLET ORAL 20110718 ANDA ANDA200177 Proficient Rx LP DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20191231 63187-948_86c94559-b453-4e61-a76c-6962872f0655 63187-948 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Proficient Rx LP INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 63187-949_2a9166ed-4d36-4d09-8c83-f0ccd6feeb74 63187-949 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Proficient Rx LP PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 63187-950_8794a786-245a-42a3-b33a-9b0ed1dd46ac 63187-950 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20150525 ANDA ANDA203047 Proficient Rx LP VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 63187-951_593a53a4-91bc-4e4a-aeff-08fc2efe3dd4 63187-951 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20160612 ANDA ANDA205150 Proficient Rx LP TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 63187-952_b59d950c-341f-45f1-b5b2-d64ccc799580 63187-952 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090324 ANDA ANDA079095 Proficient Rx LP BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 63187-953_97699821-81f8-4623-8504-e479c0f4b183 63187-953 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION RESPIRATORY (INHALATION) 20130429 ANDA ANDA090297 Proficient Rx LP LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 63187-954_f3ade814-2759-4ad0-a196-210e84d8cde9 63187-954 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20120703 NDA NDA021282 Proficient Rx LP GUAIFENESIN 600 mg/1 N 20191231 63187-955_5d91286c-5650-462f-bd3d-f3b2387afcde 63187-955 HUMAN OTC DRUG Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080410 ANDA ANDA077170 Proficient Rx LP CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20191231 63187-959_96af29b8-16b4-4113-9ec3-338438e11a49 63187-959 HUMAN PRESCRIPTION DRUG FLUTICASONE PROPIONATE fluticasone propionate CREAM TOPICAL 20040514 ANDA ANDA076451 Proficient Rx LP FLUTICASONE PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 63187-960_a4a9f535-3674-450c-b84b-b65ca1654cfb 63187-960 HUMAN OTC DRUG Guaifenesin and pseudoephedrine hydrochloride Extended Release Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20160129 ANDA ANDA091071 Proficient Rx LP GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20191231 63187-963_efc0d85e-fddc-4122-85b2-da2d2cb2f9d8 63187-963 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Proficient Rx LP TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 63187-964_e5540d90-0b6e-4519-9272-c6e96730967b 63187-964 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20151210 ANDA ANDA078279 Proficient Rx LP ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 63187-965_dbdc8fbe-c75f-4f17-a2cd-9f23802dcc5d 63187-965 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160620 ANDA ANDA204838 Proficient Rx LP ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20191231 63187-966_e77942cb-24d6-4958-b475-3c6ed57e3e5a 63187-966 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 Proficient Rx LP ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 63187-967_444b2ea0-ec42-4bcf-b8d2-38b4b297ada0 63187-967 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 Proficient Rx LP IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 63187-968_588d2434-f39c-4dd5-8564-0d756d7568dc 63187-968 HUMAN OTC DRUG Childrens Chewable Mapap Acetaminophen TABLET, CHEWABLE ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 Proficient Rx LP ACETAMINOPHEN 80 mg/1 N 20191231 63187-969_abbd2168-1523-4eb6-a75c-dc4d7d1b1c9b 63187-969 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Proficient Rx LP SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 63187-970_5451be60-1315-4152-ad13-412e86903c8a 63187-970 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Proficient Rx LP ESZOPICLONE 2 mg/1 CIV N 20191231 63189-001_c4095f72-4a64-4e94-b8a3-997ba6683632 63189-001 HUMAN OTC DRUG Phenazopyridine hydrochloride 95mg Phenazopyridine Hydrochloride TABLET ORAL 20150320 UNAPPROVED DRUG OTHER AMOL PHARMACEUTICALS PRIVATE LIMITED PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 63189-002_bce2b759-6e4c-483f-a5b0-b8a190881250 63189-002 HUMAN OTC DRUG Phenazopyridine Hydrochloride 97.5mg Phenazopyridine Hydrochloride TABLET ORAL 20150316 UNAPPROVED DRUG OTHER AMOL PHARMACEUTICALS PRIVATE LIMITED PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 63189-005_36c185aa-8855-4ceb-b535-f85d4780dcb8 63189-005 HUMAN OTC DRUG Methenamine and Sodium Salicylate METHENAMINE, SODIUM SALICYLATE TABLET ORAL 20151003 UNAPPROVED DRUG OTHER AMOL PHARMACEUTICALS PRIVATE LIMITED METHENAMINE; SODIUM SALICYLATE 162; 162.5 mg/1; mg/1 N 20181231 63214-100_8f89d317-e696-4eed-9ddb-d8b8f885d9dd 63214-100 HUMAN OTC DRUG Therapytion Nokmosu Hair Tonic salicylic acid,panthenol SPRAY TOPICAL 20140501 UNAPPROVED DRUG OTHER Therapytion Co., Ltd. SALICYLIC ACID; PANTHENOL .3; .24 g/120g; g/120g E 20171231 63214-101_dc7e61b1-f3fc-44e7-8ab7-298449b4cc11 63214-101 HUMAN OTC DRUG Therapytion Nokmosu Sensitive and Dry Hair zinc pyrithione, panthenol, niacinamide, biotin SHAMPOO TOPICAL 20140501 UNAPPROVED DRUG OTHER Therapytion Co., Ltd. PYRITHIONE ZINC; PANTHENOL; NIACINAMIDE; BIOTIN 2.1; .5; .3; .06 g/530g; g/530g; g/530g; g/530g E 20171231 63214-102_41ac95c4-a5f8-4199-b354-067982deb899 63214-102 HUMAN OTC DRUG Therapytion Nokmosu Neutral and oily Hair zinc pyrithione, panthenol, niacinamide, biotin SHAMPOO TOPICAL 20140501 UNAPPROVED DRUG OTHER Therapytion Co., Ltd. PYRITHIONE ZINC; PANTHENOL; NIACINAMIDE; BIOTIN 2.1; .5; .3; .06 g/530g; g/530g; g/530g; g/530g E 20171231 63215-001_a6e1761b-67b6-40fb-88fc-e793720d7980 63215-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Broadway Home Medical OXYGEN 99 L/100L E 20171231 63218-4000_ecdf1c1a-2824-40c6-8645-9a59e64ee10b 63218-4000 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19970317 UNAPPROVED MEDICAL GAS Arizona Respiratory & Medical Supply Services, Inc. OXYGEN 99 L/100L E 20171231 63219-100_96bd1b57-db3a-4c94-8ecb-adaa8c3bcca5 63219-100 HUMAN OTC DRUG MAMACHI MOMS STRETCH MARK CREAM Adenosine CREAM TOPICAL 20140501 UNAPPROVED DRUG OTHER Supio Co,. Ltd. ADENOSINE 6 g/150g E 20171231 63234-001_60b8643d-6475-71d3-e053-2991aa0a3a95 63234-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20110101 UNAPPROVED MEDICAL GAS Olympic Pharmacy and Healthcare Services OXYGEN 99.4 L/100L N 20181231 63240-5000_22162b5f-c013-47c2-9da6-4ffd75779a47 63240-5000 HUMAN OTC DRUG Shunga Sensation Balm Benzocain GEL TOPICAL 20000101 OTC MONOGRAPH FINAL part348 Eau Zone Oils and Fragrances LTD BENZOCAINE 5.07 g/67.5g E 20171231 63240-5001_22162b5f-c013-47c2-9da6-4ffd75779a47 63240-5001 HUMAN OTC DRUG Shunga Sensation Balm Benzocain GEL TOPICAL 20000101 OTC MONOGRAPH FINAL part348 Eau Zone Oils and Fragrances LTD BENZOCAINE 5.06 g/67.5g E 20171231 63240-5002_22162b5f-c013-47c2-9da6-4ffd75779a47 63240-5002 HUMAN OTC DRUG Shunga Sensation Balm Benzocain GEL TOPICAL 20000101 OTC MONOGRAPH FINAL part348 Eau Zone Oils and Fragrances LTD BENZOCAINE 5.07 g/67.5g E 20171231 63240-5003_22162b5f-c013-47c2-9da6-4ffd75779a47 63240-5003 HUMAN OTC DRUG Shunga Sensation Balm Benzocain GEL TOPICAL 20050101 OTC MONOGRAPH FINAL part348 Eau Zone Oils and Fragrances LTD BENZOCAINE 5.07 g/67.5g E 20171231 63240-5100_19c2c1b8-76c3-4a96-9f46-8193e9e92b3f 63240-5100 HUMAN OTC DRUG Shunga Male Genital Desensitizer Benzocaine AEROSOL, SPRAY TOPICAL 20100801 OTC MONOGRAPH FINAL part348 Eau Zone Oils & Fragrances LTD BENZOCAINE 1.125 g/15g E 20171231 63255-001_f7682908-5d83-4b5f-a879-a5b8dbaa556e 63255-001 HUMAN OTC DRUG HYSAN HUA TUO MEDICATED PLASTER Menthol, Methyl Salicylate PLASTER TOPICAL 20131204 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD MENTHOL; METHYL SALICYLATE 5; 1 g/1; g/1 N 20181231 63255-002_4106cec3-2969-4bb1-acfe-1ed26b8777fd 63255-002 HUMAN OTC DRUG HYSAN DEGUO POROUS CAPSICUM Capsicum PLASTER TOPICAL 20140228 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD CAPSICUM 3 g/1 N 20181231 63255-010_f88ff856-323d-40f6-8676-8e8e3115b823 63255-010 HUMAN OTC DRUG HYSAN HUO LU MEDICATED Methyl Salicylate, Menthol, Camphor (Synthetic) OIL TOPICAL 20131204 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 40; 36; 10 g/100mL; g/100mL; g/100mL N 20181231 63255-011_33cca65e-850c-4c5d-88af-ec2cc80b3791 63255-011 HUMAN OTC DRUG Hua Tuo Huo Lu Oil Methyl Salicylate, Menthol, Camphor (Synthetic) OIL TOPICAL 20131127 OTC MONOGRAPH NOT FINAL part348 Hysan Pharmaceutical Co Ltd METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 40; 36; 10 g/100mL; g/100mL; g/100mL N 20181231 63255-021_69568bb3-b63f-48ea-85d5-30774710dda0 63255-021 HUMAN OTC DRUG HYSAN PAIN RELIEVER METHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC), EUCALYPTUS OIL OIL TOPICAL 20120920 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC); EUCALYPTUS OIL 37; 36; 10; 10 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 63255-030_dd2a0030-13bc-4dd5-b0f0-76396ac4950c 63255-030 HUMAN OTC DRUG CORAL ANALGESIC METHYL SALICYLATE, EUCALYPTUS OIL, MENTHOL CRYSTAL, CAMPHOR (SYNTHETIC) OINTMENT TOPICAL 20140127 20200531 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD METHYL SALICYLATE; EUCALYPTUS OIL; MENTHOL; CAMPHOR (SYNTHETIC) 22; 11; 11; 2 g/100g; g/100g; g/100g; g/100g N 20181231 63255-110_09721902-5c90-435d-a150-bc9e0cf0f1d7 63255-110 HUMAN OTC DRUG HYSAN PAIN RELIEVER METHYL SALICYLATE, CAMPHOR (SYNTHETIC) OIL TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD METHYL SALICYLATE; CAMPHOR (SYNTHETIC) 37; 10 g/100mL; g/100mL N 20181231 63255-120_a0070a87-c2c0-42eb-bc31-d27c0c8d4091 63255-120 HUMAN OTC DRUG HYSAN HUO LU MEDICATED METHYL SALICYLATE, CAMPHOR (SYNTHETIC) OIL TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD METHYL SALICYLATE; CAMPHOR (SYNTHETIC) 37; 10 g/100mL; g/100mL N 20181231 63255-121_c733f179-6688-43d2-86aa-4078108d44d8 63255-121 HUMAN OTC DRUG HYSAN HUA TUO HUO LU METHYL SALICYLATE, CAMPHOR (SYNTHETIC) OIL TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD METHYL SALICYLATE; CAMPHOR (SYNTHETIC) 37; 10 g/100mL; g/100mL N 20181231 63255-310_b3e65608-9dba-414b-9754-2d9b0c274bae 63255-310 HUMAN OTC DRUG CORAL ANALGESIC METHYL SALICYLATE, CAMPHOR (SYNTHETIC) OINTMENT TOPICAL 20160509 OTC MONOGRAPH NOT FINAL part348 HYSAN PHARMACEUTICAL CO LTD METHYL SALICYLATE; CAMPHOR (SYNTHETIC) 22; 2 g/100g; g/100g N 20181231 63256-100_05246011-b7f0-40a3-ac67-b1bd8d23edac 63256-100 HUMAN PRESCRIPTION DRUG Sclerosol Talc AEROSOL, POWDER INTRAPLEURAL 20130630 NDA NDA020587 Bryan Corp TALC 4 g/25g N 20181231 63256-200_ffa7f6f2-0d63-42b4-bb48-34217d871a91 63256-200 HUMAN PRESCRIPTION DRUG Sterile Talc Talc POWDER INTRAPLEURAL 20031215 NDA NDA021388 Bryan Corporation TALC 5 g/100mL N 20181231 63261-250_2a25e7c7-d5f4-40b6-82b8-74aabc34b3e4 63261-250 HUMAN PRESCRIPTION DRUG LYMPHAZURIN isosulfan blue INJECTION, SOLUTION SUBCUTANEOUS 20120112 NDA NDA018310 UNITED STATES SURGICAL CORPORATION ISOSULFAN BLUE 10 mg/mL E 20171231 63264-101_adb612e8-d201-46c8-812b-5f48cafd322f 63264-101 HUMAN OTC DRUG SWIMMERS ITCH GUARD SPF 30 ZINC OXIDE, EUCALYPTUS OIL CREAM TOPICAL 20131229 OTC MONOGRAPH FINAL part352 RESOLUTIONS LLC ZINC OXIDE 15 g/100mL E 20171231 63272-506_2ee26677-6f6d-3a42-e054-00144ff8d46c 63272-506 HUMAN OTC DRUG SEPHORA ROUGE BALM SUNSCREEN SPF20 B07-Bashful Beige OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20151219 OTC MONOGRAPH NOT FINAL part352 INTERCOS EUROPE SPA OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.125; 3; 1.83 mg/g; mg/g; mg/g N 20181231 63272-507_2ee14dca-57bd-0928-e054-00144ff8d46c 63272-507 HUMAN OTC DRUG SEPHORA ROUGE BALM SUNSCREEN SPF20 B08-Subtle Peony OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20151219 OTC MONOGRAPH NOT FINAL part352 INTERCOS EUROPE SPA OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.125; 3; 1.83 mg/g; mg/g; mg/g N 20181231 63272-508_2ee26677-6f6e-3a42-e054-00144ff8d46c 63272-508 HUMAN OTC DRUG SEPHORA ROUGE BALM SUNSCREEN SPF20 B09-Mild Plum OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE LIPSTICK TOPICAL 20151218 OTC MONOGRAPH NOT FINAL part352 INTERCOS EUROPE SPA OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7.125; 3; 1.83 mg/g; mg/g; mg/g N 20181231 63287-211_7f9c2965-f41f-4a7d-9c36-4f1b59d90d38 63287-211 HUMAN OTC DRUG Throat-Releev (Honey and Lemon) Benzalkonium Chloride LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333A Merix Pharmaceutical Corp. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 63287-419_46bcc469-674e-1857-e054-00144ff8d46c 63287-419 HUMAN OTC DRUG RELEEV Cold Sore Treatment Benzalkonium Chloride LIQUID TOPICAL 20060601 OTC MONOGRAPH NOT FINAL part333A Merix Pharmaceutical Corp. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63287-420_9f42dc8f-e1fb-4514-92dd-bb55fab3ea3f 63287-420 HUMAN OTC DRUG shing-Releev Benzalkonium Chloride LIQUID TOPICAL 20100714 OTC MONOGRAPH NOT FINAL part333A Merix Pharmaceutical Corp. BENZALKONIUM CHLORIDE; ALLANTOIN; BENZYL ALCOHOL 1.3; 5; 5 mg/mL; mg/mL; mg/mL E 20171231 63287-425_9fa64ca3-1231-4922-9b52-295f1869746e 63287-425 HUMAN OTC DRUG Fast Results Genital Herpes Treatment Benzalkonium Chloride,Allantoin LIQUID TOPICAL 20060601 OTC MONOGRAPH NOT FINAL part333A Merix Pharmaceutical Corp. BENZALKONIUM CHLORIDE; ALLANTOIN 1.3; 5 mL/mL; mL/mL E 20171231 63289-001_3d49eb0a-d307-4ea9-a9c0-37319d56553b 63289-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19840101 UNAPPROVED MEDICAL GAS Landauer Metropolitan, Inc OXYGEN 99 L/100L E 20171231 63293-0001_b69ef924-6f29-41cd-8fcf-663404082e71 63293-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020725 UNAPPROVED MEDICAL GAS Clay Home Medical OXYGEN 99 L/100L E 20171231 63299-046_ec9e8e50-ab32-4e5b-9cff-2fc1f120f480 63299-046 HUMAN OTC DRUG ELECTRIC MEDICATED BALM Menthol and Methyl Salicylate OINTMENT TOPICAL 20080213 OTC MONOGRAPH NOT FINAL part348 FEI FAH MEDICAL MANUFACTURING PTE LTD MENTHOL; METHYL SALICYLATE 11; 22 g/100g; g/100g N 20181231 63301-001_60e0e318-d118-3b22-e053-2a91aa0a1ab4 63301-001 HUMAN OTC DRUG McD Foaming Antibacterial Hand CHLOROXYLENOL LIQUID TOPICAL 20160321 OTC MONOGRAPH NOT FINAL part333E Kath Khemicals LLC CHLOROXYLENOL 5 mg/mL N 20181231 63302-202_100843c9-eac2-4737-9479-cf06d603b6d2 63302-202 HUMAN OTC DRUG Dermazor Psoriasis and Seborrheic Dermatitis Salicylic Acid, Zinc Oxide CREAM TOPICAL 20140505 OTC MONOGRAPH FINAL part333D PRESTIGIO LTD SALICYLIC ACID 3 g/100g N 20181231 63304-097_86a8fa81-8c4e-4b29-aec5-7ee3b0b745f5 63304-097 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20090813 ANDA ANDA076554 Ranbaxy Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63304-098_86a8fa81-8c4e-4b29-aec5-7ee3b0b745f5 63304-098 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20090813 ANDA ANDA076554 Ranbaxy Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63304-099_86a8fa81-8c4e-4b29-aec5-7ee3b0b745f5 63304-099 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20090210 ANDA ANDA076572 Ranbaxy Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63304-128_e045a98a-fd37-48c0-ba67-2889a4666d8c 63304-128 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20101129 ANDA ANDA076786 Ranbaxy Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 63304-129_e045a98a-fd37-48c0-ba67-2889a4666d8c 63304-129 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20101129 ANDA ANDA076786 Ranbaxy Pharmaceuticals Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 63304-130_29149bee-75b2-4e83-a550-cf1b669219f0 63304-130 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061005 ANDA ANDA065356 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 50 mg/1 N 20181231 63304-131_29149bee-75b2-4e83-a550-cf1b669219f0 63304-131 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061005 ANDA ANDA065356 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 75 mg/1 N 20181231 63304-132_29149bee-75b2-4e83-a550-cf1b669219f0 63304-132 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061005 ANDA ANDA065356 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 100 mg/1 N 20181231 63304-154_ff91020b-46cc-4065-bff1-83b5263a2193 63304-154 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride and hydrochlorothiazide Benazepril hydrochloride and hydrochlorothiazide TABLET, COATED ORAL 20060410 ANDA ANDA077483 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63304-155_ff91020b-46cc-4065-bff1-83b5263a2193 63304-155 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride and hydrochlorothiazide Benazepril hydrochloride and hydrochlorothiazide TABLET, COATED ORAL 20060410 ANDA ANDA077483 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63304-156_ff91020b-46cc-4065-bff1-83b5263a2193 63304-156 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride and hydrochlorothiazide Benazepril hydrochloride and hydrochlorothiazide TABLET, COATED ORAL 20060410 ANDA ANDA077483 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63304-157_ff91020b-46cc-4065-bff1-83b5263a2193 63304-157 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride and hydrochlorothiazide Benazepril hydrochloride and hydrochlorothiazide TABLET, COATED ORAL 20060410 ANDA ANDA077483 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63304-158_54790349-e79b-4c35-87a3-2b906e6b79e8 63304-158 HUMAN PRESCRIPTION DRUG BROMOCRIPTINE MESYLATE bromocriptine mesylate CAPSULE ORAL 20161222 NDA NDA017962 Sun Pharmaceutical Industries, Inc. BROMOCRIPTINE MESYLATE 5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 63304-159_19edc487-123b-4cf4-8233-7b79438b6ae7 63304-159 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA078055 Ranbaxy Pharmaceuticals Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 63304-160_19edc487-123b-4cf4-8233-7b79438b6ae7 63304-160 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA078055 Ranbaxy Pharmaceuticals Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 63304-161_91baf595-84c1-47db-89b2-e6590d282dec 63304-161 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20090304 ANDA ANDA078211 Ranbaxy Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-162_91baf595-84c1-47db-89b2-e6590d282dec 63304-162 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20090304 ANDA ANDA078211 Ranbaxy Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-163_91baf595-84c1-47db-89b2-e6590d282dec 63304-163 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride and Hydrochlorothiazide Quinapril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20090304 ANDA ANDA078211 Ranbaxy Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-164_d75e7077-98f9-41d8-860c-39d556cc7a1b 63304-164 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, COATED ORAL 20070206 ANDA ANDA077977 Ranbaxy Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63304-165_d75e7077-98f9-41d8-860c-39d556cc7a1b 63304-165 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, COATED ORAL 20070206 ANDA ANDA077977 Ranbaxy Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63304-166_d75e7077-98f9-41d8-860c-39d556cc7a1b 63304-166 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, COATED ORAL 20070206 ANDA ANDA077977 Ranbaxy Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63304-167_d75e7077-98f9-41d8-860c-39d556cc7a1b 63304-167 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, COATED ORAL 20070206 ANDA ANDA077977 Ranbaxy Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63304-168_d75e7077-98f9-41d8-860c-39d556cc7a1b 63304-168 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, COATED ORAL 20070206 ANDA ANDA077977 Ranbaxy Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 200 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63304-173_29149bee-75b2-4e83-a550-cf1b669219f0 63304-173 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20061005 ANDA ANDA065356 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 150 mg/1 N 20181231 63304-191_c75190f9-96a4-421a-baf5-7fccc9695e2f 63304-191 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130305 NDA NDA204150 Sun Pharmaceutical Industries, Inc. DESVENLAFAXINE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 63304-192_c75190f9-96a4-421a-baf5-7fccc9695e2f 63304-192 HUMAN PRESCRIPTION DRUG Desvenlafaxine Desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130305 NDA NDA204150 Sun Pharmaceutical Industries, Inc. DESVENLAFAXINE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 63304-193_c09d726b-9e74-4341-a991-ff126ce179b9 63304-193 HUMAN PRESCRIPTION DRUG Milnacipran hydrochloride Milnacipran hydrochloride TABLET, FILM COATED ORAL 20141127 ANDA ANDA205088 Ranbaxy Pharmaceuticals Inc. MILNACIPRAN HYDROCHLORIDE 12.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63304-194_c09d726b-9e74-4341-a991-ff126ce179b9 63304-194 HUMAN PRESCRIPTION DRUG Milnacipran hydrochloride Milnacipran hydrochloride TABLET, FILM COATED ORAL 20141127 ANDA ANDA205088 Ranbaxy Pharmaceuticals Inc. MILNACIPRAN HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63304-205_e12bd67d-54cb-4e4c-a9b4-3c5197f2f5b1 63304-205 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL 20020705 ANDA ANDA076058 Ranbaxy Pharmaceuticlas Inc MIDAZOLAM HYDROCHLORIDE 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63304-210_ab2722ce-c08e-4cdd-a25e-756272ea463f 63304-210 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20090818 ANDA ANDA040844 Ranbaxy Pharmaceuticals Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 63304-211_ab2722ce-c08e-4cdd-a25e-756272ea463f 63304-211 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20090818 ANDA ANDA040844 Ranbaxy Pharmaceuticals Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 63304-212_c09d726b-9e74-4341-a991-ff126ce179b9 63304-212 HUMAN PRESCRIPTION DRUG Milnacipran hydrochloride Milnacipran hydrochloride TABLET, FILM COATED ORAL 20141127 ANDA ANDA205088 Ranbaxy Pharmaceuticals Inc. MILNACIPRAN HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63304-213_c09d726b-9e74-4341-a991-ff126ce179b9 63304-213 HUMAN PRESCRIPTION DRUG Milnacipran hydrochloride Milnacipran hydrochloride TABLET, FILM COATED ORAL 20141127 ANDA ANDA205088 Ranbaxy Pharmaceuticals Inc. MILNACIPRAN HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63304-214_510b79b4-038e-4df6-96ee-c519457f50bf 63304-214 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20080512 ANDA ANDA078722 Ranbaxy Pharmaceuticals Inc CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63304-215_510b79b4-038e-4df6-96ee-c519457f50bf 63304-215 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20080512 ANDA ANDA078722 Ranbaxy Pharmaceuticals Inc CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63304-216_510b79b4-038e-4df6-96ee-c519457f50bf 63304-216 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20080512 ANDA ANDA078722 Ranbaxy Pharmaceuticals Inc CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63304-218_b6f91a0b-ca7e-4af1-8ea6-741af2050314 63304-218 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150413 ANDA ANDA203506 Ranbaxy Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-219_b6f91a0b-ca7e-4af1-8ea6-741af2050314 63304-219 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150413 ANDA ANDA203506 Ranbaxy Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-220_b6f91a0b-ca7e-4af1-8ea6-741af2050314 63304-220 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150413 ANDA ANDA203506 Ranbaxy Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-221_b6f91a0b-ca7e-4af1-8ea6-741af2050314 63304-221 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150413 ANDA ANDA203506 Ranbaxy Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-222_b6f91a0b-ca7e-4af1-8ea6-741af2050314 63304-222 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150413 ANDA ANDA203506 Ranbaxy Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-223_b6f91a0b-ca7e-4af1-8ea6-741af2050314 63304-223 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150413 ANDA ANDA203506 Ranbaxy Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-224_b6f91a0b-ca7e-4af1-8ea6-741af2050314 63304-224 HUMAN PRESCRIPTION DRUG Oxymorphone hydrochloride Oxymorphone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150413 ANDA ANDA203506 Ranbaxy Pharmaceuticals Inc. OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-239_f46839cc-8b7b-4305-a177-59a347dab027 63304-239 HUMAN PRESCRIPTION DRUG CALCITRIOL CALCITRIOL CAPSULE ORAL 20090826 NDA AUTHORIZED GENERIC NDA018044 Sun Pharmaceutical Industries, Inc. CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 63304-240_f46839cc-8b7b-4305-a177-59a347dab027 63304-240 HUMAN PRESCRIPTION DRUG CALCITRIOL CALCITRIOL CAPSULE ORAL 20090826 NDA AUTHORIZED GENERIC NDA018044 Sun Pharmaceutical Industries, Inc. CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 63304-241_f46839cc-8b7b-4305-a177-59a347dab027 63304-241 HUMAN PRESCRIPTION DRUG CALCITRIOL CALCITRIOL SOLUTION ORAL 20090826 NDA AUTHORIZED GENERIC NDA021068 Sun Pharmaceutical Industries, Inc. CALCITRIOL 1 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 63304-296_5a71ed2d-1d00-404e-bf2c-475cfd9e278c 63304-296 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 Ranbaxy Pharmaceuticals Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] E 20171231 63304-311_a2a31eaf-b314-445c-a7dd-42a363a04092 63304-311 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Ranbaxy Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 63304-312_a2a31eaf-b314-445c-a7dd-42a363a04092 63304-312 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Ranbaxy Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 63304-313_a2a31eaf-b314-445c-a7dd-42a363a04092 63304-313 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Ranbaxy Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 63304-337_8fdc8bda-635a-401f-a9b5-8a2a514b429e 63304-337 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 63304-338_8fdc8bda-635a-401f-a9b5-8a2a514b429e 63304-338 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 63304-339_8fdc8bda-635a-401f-a9b5-8a2a514b429e 63304-339 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 63304-340_8fdc8bda-635a-401f-a9b5-8a2a514b429e 63304-340 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 63304-346_1b169f76-a9a5-4704-a81c-094b497217a7 63304-346 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20120110 ANDA ANDA078602 Rnabaxy Pharmaceuticals Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63304-347_1b169f76-a9a5-4704-a81c-094b497217a7 63304-347 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20120110 ANDA ANDA078602 Rnabaxy Pharmaceuticals Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63304-400_88603d5f-4ad0-46ab-999f-740312dc35dc 63304-400 HUMAN PRESCRIPTION DRUG Oxycodone HCl Controlled-Release Oxycodone HCl Controlled-Release TABLET ORAL 20100201 NDA NDA020553 Ranbaxy Pharmaceuticals Inc OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63304-401_88603d5f-4ad0-46ab-999f-740312dc35dc 63304-401 HUMAN PRESCRIPTION DRUG Oxycodone HCl Controlled-Release Oxycodone HCl Controlled-Release TABLET ORAL 20100201 NDA NDA020553 Ranbaxy Pharmaceuticals Inc OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63304-403_02e7b2aa-cc39-461b-b7b1-b0576b7c959e 63304-403 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20041220 ANDA ANDA076739 Ranbaxy Pharmaceuticals Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63304-404_02e7b2aa-cc39-461b-b7b1-b0576b7c959e 63304-404 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20041220 ANDA ANDA076739 Ranbaxy Pharmaceuticals Inc. FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63304-433_95731d59-9e8b-40a3-bdac-da02acaac02b 63304-433 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20130225 ANDA ANDA201653 Ranbaxy Pharmaceuticals Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 63304-435_b951455c-c235-4e23-9e21-08672d108726 63304-435 HUMAN PRESCRIPTION DRUG FELODIPINEEXTENDED-RELEASE TABLETS felodipine TABLET, EXTENDED RELEASE ORAL 20080910 NDA NDA019834 Ranbaxy Pharmaceuticals Inc FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63304-436_b951455c-c235-4e23-9e21-08672d108726 63304-436 HUMAN PRESCRIPTION DRUG FELODIPINEEXTENDED-RELEASE TABLETS felodipine TABLET, EXTENDED RELEASE ORAL 20080910 NDA NDA019834 Ranbaxy Pharmaceuticals Inc FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63304-437_b951455c-c235-4e23-9e21-08672d108726 63304-437 HUMAN PRESCRIPTION DRUG FELODIPINEEXTENDED-RELEASE TABLETS felodipine TABLET, EXTENDED RELEASE ORAL 20080910 NDA NDA019834 Ranbaxy Pharmaceuticals Inc FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63304-443_c7d1c1c1-bb96-4ad1-9536-1b20a7b4365b 63304-443 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20150302 ANDA ANDA201748 Ranbaxy Pharmaceuticals Inc. FENOFIBRATE 43 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 63304-444_c7d1c1c1-bb96-4ad1-9536-1b20a7b4365b 63304-444 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate CAPSULE ORAL 20150302 ANDA ANDA201748 Ranbaxy Pharmaceuticals Inc. FENOFIBRATE 130 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 63304-445_b43f6b44-9de3-4efb-a467-487aee28f6a0 63304-445 HUMAN PRESCRIPTION DRUG Omeprazole Delayed-Release Omeprazole CAPSULE, DELAYED RELEASE ORAL 20080725 NDA NDA019810 Ranbaxy Laboratories Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 63304-448_841de1e1-a070-4ed6-b065-f302408950e8 63304-448 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20130110 ANDA ANDA200884 Sun Pharmaceutical Industries, Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 63304-449_841de1e1-a070-4ed6-b065-f302408950e8 63304-449 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate TABLET, FILM COATED ORAL 20130110 ANDA ANDA200884 Sun Pharmaceutical Industries, Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 63304-450_111f3a79-141c-4c16-94b1-b5bc51966c01 63304-450 HUMAN PRESCRIPTION DRUG Morphine sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120511 ANDA ANDA078761 Ranbaxy Pharmaceuticals Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-451_111f3a79-141c-4c16-94b1-b5bc51966c01 63304-451 HUMAN PRESCRIPTION DRUG Morphine sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120511 ANDA ANDA078761 Ranbaxy Pharmaceuticals Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-452_111f3a79-141c-4c16-94b1-b5bc51966c01 63304-452 HUMAN PRESCRIPTION DRUG Morphine sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120511 ANDA ANDA078761 Ranbaxy Pharmaceuticals Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-453_111f3a79-141c-4c16-94b1-b5bc51966c01 63304-453 HUMAN PRESCRIPTION DRUG Morphine sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120511 ANDA ANDA078761 Ranbaxy Pharmaceuticals Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-458_834bc56a-657d-4733-9a60-47040cb5c7bf 63304-458 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Ranbaxy Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 63304-459_834bc56a-657d-4733-9a60-47040cb5c7bf 63304-459 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Ranbaxy Pharmaceuticals Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 63304-460_cfca0747-ed49-447d-be28-98c231a5c80d 63304-460 HUMAN PRESCRIPTION DRUG Chloroquine phosphate Chloroquine phosphate TABLET, FILM COATED ORAL 20110315 ANDA ANDA090610 Ranbaxy Pharmaceuticals Inc. CHLOROQUINE PHOSPHATE 250 mg/1 Antimalarial [EPC] N 20181231 63304-461_78f66195-aad3-4abf-bcec-7ad609fbefa7 63304-461 HUMAN PRESCRIPTION DRUG Chloroquine Phosphate Chloroquine Phosphate TABLET, FILM COATED ORAL 20110315 ANDA ANDA090249 Ranbaxy Pharmaceuticals Inc. CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] N 20181231 63304-479_e8b52e90-9551-4492-b420-dafb3a0a903b 63304-479 HUMAN PRESCRIPTION DRUG Cevimeline Cevimeline CAPSULE ORAL 20160310 NDA NDA020989 Sun Pharmaceutical Industries, Inc. CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20191231 63304-497_d3a18703-b471-482c-9d30-6e8ed02355b0 63304-497 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20070816 ANDA ANDA040826 Ranbaxy Pharmaceuticals Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 63304-499_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-499 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-500_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-500 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-501_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-501 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-502_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-502 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-503_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-503 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 2.5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-504_7a18c7e7-b635-439a-8f8b-8dac5704fba6 63304-504 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 19990208 ANDA ANDA074980 Ranbaxy Laboratories Ltd. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63304-505_7a18c7e7-b635-439a-8f8b-8dac5704fba6 63304-505 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir TABLET ORAL 19990208 ANDA ANDA074980 Ranbaxy Laboratories Ltd. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63304-522_c9c61aa4-3278-4366-b292-e9a7e321fc8d 63304-522 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20160917 ANDA ANDA075556 Ranbaxy Pharmaceuticals Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63304-523_c9c61aa4-3278-4366-b292-e9a7e321fc8d 63304-523 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20160917 ANDA ANDA075556 Ranbaxy Pharmaceuticals Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63304-524_c9c61aa4-3278-4366-b292-e9a7e321fc8d 63304-524 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20160917 ANDA ANDA075556 Ranbaxy Pharmaceuticals Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63304-525_c9c61aa4-3278-4366-b292-e9a7e321fc8d 63304-525 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20160917 ANDA ANDA075556 Ranbaxy Pharmaceuticals Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63304-531_fa388520-7909-4c9e-b4a5-cf017bab015d 63304-531 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 Ranbaxy Pharmaceuticals Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-532_fa388520-7909-4c9e-b4a5-cf017bab015d 63304-532 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 Ranbaxy Pharmaceuticals Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-533_fa388520-7909-4c9e-b4a5-cf017bab015d 63304-533 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 Ranbaxy Pharmaceuticals Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-534_fa388520-7909-4c9e-b4a5-cf017bab015d 63304-534 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 Ranbaxy Pharmaceuticals Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-535_fa388520-7909-4c9e-b4a5-cf017bab015d 63304-535 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 Ranbaxy Pharmaceuticals Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-536_b119c7cd-d261-41ca-94a4-d01ace9e4929 63304-536 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20020702 ANDA ANDA076007 Ranbaxy Pharmaceuticals Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63304-537_b119c7cd-d261-41ca-94a4-d01ace9e4929 63304-537 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20020702 ANDA ANDA076007 Ranbaxy Pharmaceuticals Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63304-538_b119c7cd-d261-41ca-94a4-d01ace9e4929 63304-538 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20020702 ANDA ANDA076007 Ranbaxy Pharmaceuticals Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63304-539_205867ab-d40a-4f09-8338-4509e576ac95 63304-539 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20110606 ANDA ANDA090637 Ranbaxy Pharmaceuticals Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 63304-540_205867ab-d40a-4f09-8338-4509e576ac95 63304-540 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20110606 ANDA ANDA090637 Ranbaxy Pharmaceuticals Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 63304-548_fbea9a22-e8f7-43c6-9a85-9e49aef6affd 63304-548 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20070924 ANDA ANDA076607 Ranbaxy Pharmaceuticals Inc. QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-549_fbea9a22-e8f7-43c6-9a85-9e49aef6affd 63304-549 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20070924 ANDA ANDA076607 Ranbaxy Pharmaceuticals Inc. QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-550_fbea9a22-e8f7-43c6-9a85-9e49aef6affd 63304-550 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20070924 ANDA ANDA076607 Ranbaxy Pharmaceuticals Inc. QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-551_fbea9a22-e8f7-43c6-9a85-9e49aef6affd 63304-551 HUMAN PRESCRIPTION DRUG Quinapril quinapril TABLET, FILM COATED ORAL 20070924 ANDA ANDA076607 Ranbaxy Pharmaceuticals Inc. QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-552_9288b398-2811-4f9b-a088-c719de4dc8f4 63304-552 HUMAN PRESCRIPTION DRUG Clorazepate dipotassium Clorazepate dipotassium TABLET ORAL 20050114 ANDA ANDA076911 Ranbaxy Pharmaceuticals Inc. CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63304-553_9288b398-2811-4f9b-a088-c719de4dc8f4 63304-553 HUMAN PRESCRIPTION DRUG Clorazepate dipotassium Clorazepate dipotassium TABLET ORAL 20050114 ANDA ANDA076911 Ranbaxy Pharmaceuticals Inc. CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63304-554_9288b398-2811-4f9b-a088-c719de4dc8f4 63304-554 HUMAN PRESCRIPTION DRUG Clorazepate dipotassium Clorazepate dipotassium TABLET ORAL 20050114 ANDA ANDA076911 Ranbaxy Pharmaceuticals Inc. CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63304-561_607ef64e-c16f-4433-85e1-092fff03bbab 63304-561 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19800123 ANDA ANDA087083 Sun Pharmaceutical Industries, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 60; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 63304-562_607ef64e-c16f-4433-85e1-092fff03bbab 63304-562 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19781116 ANDA ANDA085868 Sun Pharmaceutical Industries, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 63304-579_80c4c66e-f913-4026-854e-f37b35ebf70c 63304-579 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090324 ANDA ANDA078459 Ranbaxy Pharmaceuticals Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63304-580_80c4c66e-f913-4026-854e-f37b35ebf70c 63304-580 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090315 ANDA ANDA078459 Ranbaxy Pharmaceuticals Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63304-581_80c4c66e-f913-4026-854e-f37b35ebf70c 63304-581 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090315 ANDA ANDA078459 Ranbaxy Pharmaceuticals Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63304-587_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-587 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-588_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-588 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-589_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-589 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20040130 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-590_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-590 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-591_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-591 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-599_fa388520-7909-4c9e-b4a5-cf017bab015d 63304-599 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060515 ANDA ANDA075944 Ranbaxy Pharmaceuticals Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63304-603_637c6e1b-099a-4f59-8a06-ca38456862a7 63304-603 HUMAN PRESCRIPTION DRUG amlodipine besylate and atorvastatin calcium amlodipine besylate and atorvastatin calcium TABLET, FILM COATED ORAL 20111206 NDA AUTHORIZED GENERIC NDA021540 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE 10; 80 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-614_66d37abb-3581-45ad-a902-470079c4a608 63304-614 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20001226 ANDA ANDA065053 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 50 mg/1 N 20181231 63304-615_66d37abb-3581-45ad-a902-470079c4a608 63304-615 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20001226 ANDA ANDA065053 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 75 mg/1 N 20181231 63304-616_66d37abb-3581-45ad-a902-470079c4a608 63304-616 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20001226 ANDA ANDA065053 Ranbaxy Pharmaceuticals Inc. DOXYCYCLINE 100 mg/1 N 20181231 63304-621_73fb01d6-5dd9-485a-ac30-59c176b2c095 63304-621 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Ranbaxy Pharmaceuticals Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63304-622_73fb01d6-5dd9-485a-ac30-59c176b2c095 63304-622 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Ranbaxy Pharmaceuticals Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63304-623_73fb01d6-5dd9-485a-ac30-59c176b2c095 63304-623 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Ranbaxy Pharmaceuticals Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63304-624_71ce103c-23d0-47fe-b2e0-4249618ab8ed 63304-624 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Ranbaxy Pharmaceuticals Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63304-625_71ce103c-23d0-47fe-b2e0-4249618ab8ed 63304-625 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Ranbaxy Pharmaceuticals Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63304-626_71ce103c-23d0-47fe-b2e0-4249618ab8ed 63304-626 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Ranbaxy Pharmaceuticals Inc. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63304-627_3ac31363-4eb4-4333-ba7f-fc2db7b42439 63304-627 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20051102 ANDA ANDA076606 Ranbaxy Pharmaceuticals Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63304-628_3ac31363-4eb4-4333-ba7f-fc2db7b42439 63304-628 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20051102 ANDA ANDA076606 Ranbaxy Pharmaceuticals Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63304-629_3ac31363-4eb4-4333-ba7f-fc2db7b42439 63304-629 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20051102 ANDA ANDA076606 Ranbaxy Pharmaceuticals Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63304-632_c376ceaf-1525-49a6-9b9d-f1115f146a33 63304-632 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine CAPSULE ORAL 20050720 ANDA ANDA076990 Ranbaxy Pharmaceuticals Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63304-636_3406db8a-5ae9-4120-94bd-036701adbeca 63304-636 HUMAN PRESCRIPTION DRUG GANCICLOVIR GANCICLOVIR CAPSULE ORAL 20030827 ANDA ANDA076457 Ranbaxy Pharmaceuticals Inc. GANCICLOVIR 250 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] E 20171231 63304-637_3406db8a-5ae9-4120-94bd-036701adbeca 63304-637 HUMAN PRESCRIPTION DRUG GANCICLOVIR GANCICLOVIR CAPSULE ORAL 20030827 ANDA ANDA076457 Ranbaxy Pharmaceuticals Inc. GANCICLOVIR 500 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] E 20171231 63304-643_a39eb097-ad34-43ed-b6df-a5e4b7d7eee9 63304-643 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100806 ANDA ANDA078474 Ranbaxy Pharmaceuticals Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 63304-644_a39eb097-ad34-43ed-b6df-a5e4b7d7eee9 63304-644 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100806 ANDA ANDA078474 Ranbaxy Pharmaceuticals Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 63304-652_7a18c7e7-b635-439a-8f8b-8dac5704fba6 63304-652 HUMAN PRESCRIPTION DRUG Acyclovir acyclovir CAPSULE ORAL 19990208 ANDA ANDA074975 Ranbaxy Laboratories Ltd. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63304-653_5989f59b-7495-45ed-a245-1e404264175e 63304-653 HUMAN PRESCRIPTION DRUG Oxcarbazepine oxcarbazepine SUSPENSION ORAL 20091214 ANDA ANDA078734 Ranbaxy Pharmaceuticals Inc. OXCARBAZEPINE 60 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63304-683_056f088d-cff1-4b46-8539-ff85880586bf 63304-683 HUMAN PRESCRIPTION DRUG OXYCODONE HCl oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Ranbaxy Pharmaceuticals Inc. OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-684_056f088d-cff1-4b46-8539-ff85880586bf 63304-684 HUMAN PRESCRIPTION DRUG OXYCODONE HCl oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Ranbaxy Pharmaceuticals Inc. OXYCODONE HYDROCHLORIDE 80 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-692_45b05bbf-b11a-4431-97b8-4137c683f39e 63304-692 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Ranbaxy Pharmaceuticals Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63304-693_45b05bbf-b11a-4431-97b8-4137c683f39e 63304-693 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Ranbaxy Pharmaceuticals Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63304-694_1ffca7b6-8f19-4a26-9578-cbdd72296068 63304-694 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Ranbaxy Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 63304-695_1ffca7b6-8f19-4a26-9578-cbdd72296068 63304-695 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Ranbaxy Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 63304-696_1ffca7b6-8f19-4a26-9578-cbdd72296068 63304-696 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Ranbaxy Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 63304-697_4a8d201f-b0b6-4463-af35-8f241caf048b 63304-697 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20040629 ANDA ANDA065156 Ranbaxy Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 63304-698_4a8d201f-b0b6-4463-af35-8f241caf048b 63304-698 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20040629 ANDA ANDA065156 Ranbaxy Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 63304-699_4a8d201f-b0b6-4463-af35-8f241caf048b 63304-699 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20040629 ANDA ANDA065156 Ranbaxy Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 63304-709_aa0b6a4a-f8ff-4d09-8813-2d58192c08c5 63304-709 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075747 Ranbaxy Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 63304-710_aa0b6a4a-f8ff-4d09-8813-2d58192c08c5 63304-710 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075747 Ranbaxy Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 63304-711_aa0b6a4a-f8ff-4d09-8813-2d58192c08c5 63304-711 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075747 Ranbaxy Pharmaceuticals Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 63304-718_939dd84a-4df5-40fe-84db-1b0e642d4f73 63304-718 HUMAN PRESCRIPTION DRUG Diltiazem hydrochloride Diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130314 ANDA ANDA203023 Sun Pharmaceutical Industries, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63304-719_939dd84a-4df5-40fe-84db-1b0e642d4f73 63304-719 HUMAN PRESCRIPTION DRUG Diltiazem hydrochloride Diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130314 ANDA ANDA203023 Sun Pharmaceutical Industries, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63304-720_939dd84a-4df5-40fe-84db-1b0e642d4f73 63304-720 HUMAN PRESCRIPTION DRUG Diltiazem hydrochloride Diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130314 ANDA ANDA203023 Sun Pharmaceutical Industries, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63304-721_939dd84a-4df5-40fe-84db-1b0e642d4f73 63304-721 HUMAN PRESCRIPTION DRUG Diltiazem hydrochloride Diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130314 ANDA ANDA203023 Sun Pharmaceutical Industries, Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63304-722_939dd84a-4df5-40fe-84db-1b0e642d4f73 63304-722 HUMAN PRESCRIPTION DRUG Diltiazem hydrochloride Diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130314 ANDA ANDA203023 Sun Pharmaceutical Industries, Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63304-725_1cf704dd-e3e3-4ae6-9b3e-f67116212adc 63304-725 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20050525 ANDA ANDA065174 Ranbaxy Pharmaceuticals Inc. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63304-726_1cf704dd-e3e3-4ae6-9b3e-f67116212adc 63304-726 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20050525 ANDA ANDA065174 Ranbaxy Pharmaceuticals Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63304-736_f24643e9-a2bc-47f0-9e4c-4214d5464323 63304-736 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076344 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63304-737_f24643e9-a2bc-47f0-9e4c-4214d5464323 63304-737 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076344 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63304-738_f24643e9-a2bc-47f0-9e4c-4214d5464323 63304-738 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076344 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63304-739_f24643e9-a2bc-47f0-9e4c-4214d5464323 63304-739 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride benazepril hydrochloride TABLET, FILM COATED ORAL 20040211 ANDA ANDA076344 Ranbaxy Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63304-758_111f3a79-141c-4c16-94b1-b5bc51966c01 63304-758 HUMAN PRESCRIPTION DRUG Morphine sulfate morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120511 ANDA ANDA078761 Ranbaxy Pharmaceuticals Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63304-768_de18b1f7-d919-47b1-8bab-eff03ca5ea8f 63304-768 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium SUSPENSION ORAL 20070313 ANDA ANDA065207 Ranbaxy Pharmaceuticals Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 63304-772_ff52848c-6705-4ef1-bb6e-fce0e78b9a69 63304-772 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 Ranbaxy Pharmaceuticals Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63304-773_ff52848c-6705-4ef1-bb6e-fce0e78b9a69 63304-773 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 Ranbaxy Pharmaceuticals Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63304-774_ff52848c-6705-4ef1-bb6e-fce0e78b9a69 63304-774 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 Ranbaxy Pharmaceuticals Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63304-778_831ec733-ecc5-4461-a462-0dbc11811df1 63304-778 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20100104 ANDA ANDA076327 Ranbaxy Pharmaceuticals Inc TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63304-779_831ec733-ecc5-4461-a462-0dbc11811df1 63304-779 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20100104 ANDA ANDA076327 Ranbaxy Pharmaceuticals Inc TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63304-780_831ec733-ecc5-4461-a462-0dbc11811df1 63304-780 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20100104 ANDA ANDA076327 Ranbaxy Pharmaceuticals Inc TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63304-789_d005a31b-31ba-400e-a75c-99e6adf745bd 63304-789 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA076285 Ranbaxy Pharmaceuticals Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-790_d005a31b-31ba-400e-a75c-99e6adf745bd 63304-790 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA076285 Ranbaxy Pharmaceuticals Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-791_d005a31b-31ba-400e-a75c-99e6adf745bd 63304-791 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA076285 Ranbaxy Pharmaceuticals Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-792_d005a31b-31ba-400e-a75c-99e6adf745bd 63304-792 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA076285 Ranbaxy Pharmaceuticals Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-793_d005a31b-31ba-400e-a75c-99e6adf745bd 63304-793 HUMAN PRESCRIPTION DRUG Simvastatin simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA076285 Ranbaxy Pharmaceuticals Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-794_f13a72ef-8d6e-42e8-985e-d31ec9c07525 63304-794 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide TABLET ORAL 20040228 ANDA ANDA076421 Ranbaxy Pharmaceuticals Inc. FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] N 20181231 63304-795_f13a72ef-8d6e-42e8-985e-d31ec9c07525 63304-795 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide TABLET ORAL 20040228 ANDA ANDA076421 Ranbaxy Pharmaceuticals Inc. FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 63304-796_f13a72ef-8d6e-42e8-985e-d31ec9c07525 63304-796 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide TABLET ORAL 20040228 ANDA ANDA076421 Ranbaxy Pharmaceuticals Inc. FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 63304-821_1cf704dd-e3e3-4ae6-9b3e-f67116212adc 63304-821 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin GRANULE, FOR SUSPENSION ORAL 20071003 ANDA ANDA065382 Ranbaxy Pharmaceuticals Inc. CLARITHROMYCIN 125 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63304-822_1cf704dd-e3e3-4ae6-9b3e-f67116212adc 63304-822 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin GRANULE, FOR SUSPENSION ORAL 20071003 ANDA ANDA065382 Ranbaxy Pharmaceuticals Inc. CLARITHROMYCIN 250 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63304-827_f4349eab-b0b0-45f0-b3e1-0d104c22ee96 63304-827 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Ranbaxy Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-828_f4349eab-b0b0-45f0-b3e1-0d104c22ee96 63304-828 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Ranbaxy Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-829_f4349eab-b0b0-45f0-b3e1-0d104c22ee96 63304-829 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Ranbaxy Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-830_f4349eab-b0b0-45f0-b3e1-0d104c22ee96 63304-830 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Ranbaxy Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63304-845_38615cef-95ad-4574-b433-422037e5658d 63304-845 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20090313 ANDA ANDA078807 Ranbaxy Pharmaceuticals Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 63304-846_38615cef-95ad-4574-b433-422037e5658d 63304-846 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20090313 ANDA ANDA078807 Ranbaxy Pharmaceuticals Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 63304-864_d618acad-1835-4148-a345-aa1054c367ff 63304-864 HUMAN PRESCRIPTION DRUG Febuxostat Febuxostat TABLET, FILM COATED ORAL 20150117 ANDA ANDA205392 Ranbaxy Pharmaceuticals Inc. FEBUXOSTAT 40 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 63304-865_d618acad-1835-4148-a345-aa1054c367ff 63304-865 HUMAN PRESCRIPTION DRUG Febuxostat Febuxostat TABLET, FILM COATED ORAL 20150117 ANDA ANDA205392 Ranbaxy Pharmaceuticals Inc. FEBUXOSTAT 80 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 63304-873_7902ab68-c66f-450e-8274-4959243f2e4e 63304-873 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077974 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63304-874_7902ab68-c66f-450e-8274-4959243f2e4e 63304-874 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077974 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63304-875_7902ab68-c66f-450e-8274-4959243f2e4e 63304-875 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077974 Ranbaxy Pharmaceuticals Inc AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63304-900_3811e946-7f9a-4e2f-8d94-3a486aaae304 63304-900 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 Ranbaxy Pharmaceuticals Inc. FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 63304-901_3811e946-7f9a-4e2f-8d94-3a486aaae304 63304-901 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 Ranbaxy Pharmaceuticals Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 63304-904_ba7172b3-5f95-4ee1-bc30-a597fca364d4 63304-904 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20070131 ANDA ANDA076588 Ranbaxy Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63304-905_ba7172b3-5f95-4ee1-bc30-a597fca364d4 63304-905 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20070131 ANDA ANDA076588 Ranbaxy Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63304-924_605edb0e-20d8-48e5-82b9-cd8ddcfd5e9d 63304-924 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET, EXTENDED RELEASE ORAL 20170901 ANDA ANDA205689 Sun Pharmaceutical Industries, Inc. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63304-925_605edb0e-20d8-48e5-82b9-cd8ddcfd5e9d 63304-925 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET, EXTENDED RELEASE ORAL 20170901 ANDA ANDA205689 Sun Pharmaceutical Industries, Inc. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63304-926_605edb0e-20d8-48e5-82b9-cd8ddcfd5e9d 63304-926 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET, EXTENDED RELEASE ORAL 20170901 ANDA ANDA205689 Sun Pharmaceutical Industries, Inc. GUANFACINE HYDROCHLORIDE 3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63304-927_605edb0e-20d8-48e5-82b9-cd8ddcfd5e9d 63304-927 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET, EXTENDED RELEASE ORAL 20170901 ANDA ANDA205689 Sun Pharmaceutical Industries, Inc. GUANFACINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63304-949_a39eb097-ad34-43ed-b6df-a5e4b7d7eee9 63304-949 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100806 ANDA ANDA077542 Ranbaxy Pharmaceuticals Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 63304-950_a39eb097-ad34-43ed-b6df-a5e4b7d7eee9 63304-950 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100806 ANDA ANDA077542 Ranbaxy Pharmaceuticals Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 63304-951_a39eb097-ad34-43ed-b6df-a5e4b7d7eee9 63304-951 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100806 ANDA ANDA077542 Ranbaxy Pharmaceuticals Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 63304-958_6db14b9b-5e94-4cd5-9d7b-cdf97d383648 63304-958 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN SUSPENSION ORAL 20011029 ANDA ANDA065081 Ranbaxy Pharmaceuticals Inc. CEPHALEXIN 125 mg/5mL E 20171231 63304-959_6db14b9b-5e94-4cd5-9d7b-cdf97d383648 63304-959 HUMAN PRESCRIPTION DRUG CEPHALEXIN CEPHALEXIN SUSPENSION ORAL 20011029 ANDA ANDA065081 Ranbaxy Pharmaceuticals Inc. CEPHALEXIN 250 mg/5mL E 20171231 63304-962_54790349-e79b-4c35-87a3-2b906e6b79e8 63304-962 HUMAN PRESCRIPTION DRUG BROMOCRIPTINE MESYLATE bromocriptine mesylate TABLET ORAL 20161222 NDA NDA017962 Sun Pharmaceutical Industries, Inc. BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 63304-963_037e5290-f39e-45ef-a05c-51b0ce2c4473 63304-963 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil For Oral Suspension Cefuroxime Axetil SUSPENSION ORAL 20080208 ANDA ANDA065323 Ranbaxy Pharmaceuticals Inc CEFUROXIME AXETIL 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63304-964_037e5290-f39e-45ef-a05c-51b0ce2c4473 63304-964 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil For Oral Suspension Cefuroxime Axetil SUSPENSION ORAL 20080208 ANDA ANDA065323 Ranbaxy Pharmaceuticals Inc CEFUROXIME AXETIL 250 mg/mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63304-967_a2a8267c-da20-473f-814c-8acaffca215e 63304-967 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20120502 ANDA ANDA200794 Ranbaxy Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 63304-968_a2a8267c-da20-473f-814c-8acaffca215e 63304-968 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20120502 ANDA ANDA200794 Ranbaxy Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 63304-973_a95b07d7-65c1-438d-91e0-0eaca684eccf 63304-973 HUMAN PRESCRIPTION DRUG CEFADROXIL cefadroxil monohydrate POWDER, FOR SUSPENSION ORAL 20050830 ANDA ANDA065115 Ranbaxy Pharmaceuticals Inc. CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63304-974_a95b07d7-65c1-438d-91e0-0eaca684eccf 63304-974 HUMAN PRESCRIPTION DRUG CEFADROXIL cefadroxil monohydrate POWDER, FOR SUSPENSION ORAL 20050830 ANDA ANDA065115 Ranbaxy Pharmaceuticals Inc. CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63323-010_c20247d3-9bd2-44f4-9a09-54cbe7d74c56 63323-010 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000810 ANDA ANDA062366 Fresenius Kabi USA, LLC GENTAMICIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 63323-011_00bd45d9-faa9-442c-a66b-3d18c004cfcc 63323-011 HUMAN PRESCRIPTION DRUG Chloramphenicol Sodium Succinate CHLORAMPHENICOL SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010112 ANDA ANDA062365 Fresenius Kabi USA, LLC CHLORAMPHENICOL SODIUM SUCCINATE 1 g/10mL Amphenicol-class Antibacterial [EPC],Amphenicols [Chemical/Ingredient] N 20181231 63323-013_80e05c97-19b6-4cd5-81bf-6af1978bcf22 63323-013 HUMAN PRESCRIPTION DRUG Thiamine THIAMINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000901 ANDA ANDA080556 Fresenius Kabi USA, LLC THIAMINE HYDROCHLORIDE 100 mg/mL N 20181231 63323-025_6927dda5-b1b9-41f8-954f-5dc67ca99ed0 63323-025 HUMAN PRESCRIPTION DRUG Chorionic Gonadotropin Chorionic Gonadotropin KIT 20110421 NDA NDA017067 Fresenius Kabi USA, LLC N 20181231 63323-030_6927dda5-b1b9-41f8-954f-5dc67ca99ed0 63323-030 HUMAN PRESCRIPTION DRUG Chorionic Gonadotropin Chorionic Gonadotropin KIT 20110421 NDA NDA017067 Fresenius Kabi USA, LLC N 20181231 63323-047_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-047 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017651 Fresenius Kabi USA, LLC HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63323-064_a58b57ad-d991-4338-b0bb-72cf960794d3 63323-064 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000808 NDA NDA019316 Fresenius Kabi USA, LLC MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 63323-083_723baff7-8c36-4ad9-a8ae-72255c644639 63323-083 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20170728 UNAPPROVED DRUG OTHER Fresensius Kabi USA, LLC SODIUM BICARBONATE 42 mg/mL N 20181231 63323-086_3d39f2fc-640b-468e-88d7-b9e8f7ae27d4 63323-086 HUMAN PRESCRIPTION DRUG Potassium Phosphates POTASSIUM PHOSPHATE, MONOBASIC and POTASSIUM PHOSPHATE, DIBASIC INJECTION, SOLUTION INTRAVENOUS 20000808 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC 224; 236 mg/mL; mg/mL N 20181231 63323-089_723baff7-8c36-4ad9-a8ae-72255c644639 63323-089 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20170728 UNAPPROVED DRUG OTHER Fresensius Kabi USA, LLC SODIUM BICARBONATE 84 mg/mL N 20181231 63323-101_f48b1ac2-923f-4825-9c44-02df9253cf96 63323-101 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20000614 ANDA ANDA063277 Fresenius Kabi USA, LLC DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 63323-102_bc6ffc23-0e65-471a-bb2d-2482e95437c3 63323-102 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110726 ANDA ANDA090799 Fresenius Kabi USA, LLC GEMCITABINE HYDROCHLORIDE 200 mg/5.26mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 63323-103_1355b932-bdb6-4c06-b2db-b8dfdd0d6c6a 63323-103 HUMAN PRESCRIPTION DRUG Cisplatin CISPLATIN INJECTION, SOLUTION INTRAVENOUS 20000905 ANDA ANDA074735 Fresenius Kabi USA, LLC CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 63323-104_f65d553d-9ac5-4dd3-b287-61efa333bd32 63323-104 HUMAN PRESCRIPTION DRUG Etoposide ETOPOSIDE INJECTION, SOLUTION INTRAVENOUS 20010718 ANDA ANDA074983 Fresenius Kabi USA, LLC ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 63323-106_8f6d204d-81d9-4047-ae19-fc8a87da0ea1 63323-106 HUMAN PRESCRIPTION DRUG magnesium sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAVENOUS 20160315 ANDA ANDA206485 Fresenius Kabi USA, LLC MAGNESIUM SULFATE HEPTAHYDRATE 40 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 63323-107_8f6d204d-81d9-4047-ae19-fc8a87da0ea1 63323-107 HUMAN PRESCRIPTION DRUG magnesium sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAVENOUS 20160315 ANDA ANDA206485 Fresenius Kabi USA, LLC MAGNESIUM SULFATE HEPTAHYDRATE 80 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 63323-108_25b72d61-4905-42ca-945c-33acd9130b61 63323-108 HUMAN PRESCRIPTION DRUG Magnesium Sulfate in 5% Dextrose Magnesium Sulfate Heptahydrate INJECTION, SOLUTION INTRAVENOUS 20160307 ANDA ANDA206486 Fresenius Kabi USA, LLC MAGNESIUM SULFATE HEPTAHYDRATE 1 g/100mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 63323-117_927b034a-7359-42c7-933c-f1534230c358 63323-117 HUMAN PRESCRIPTION DRUG Fluorouracil FLUOROURACIL INJECTION, SOLUTION INTRAVENOUS 20170102 ANDA ANDA040279 Fresenius Kabi USA, LLC FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 63323-117_bb530f92-6ccf-443a-a5d3-64f28cc14956 63323-117 HUMAN PRESCRIPTION DRUG Fluorouracil FLUOROURACIL INJECTION, SOLUTION INTRAVENOUS 20000712 ANDA ANDA040278 Fresenius Kabi USA, LLC FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 63323-120_6594799a-7b02-4847-aff7-1cb7842771bd 63323-120 HUMAN PRESCRIPTION DRUG Cytarabine CYTARABINE INJECTION, SOLUTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 20041129 ANDA ANDA076512 Fresenius Kabi USA, LLC CYTARABINE 100 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 63323-121_7723227d-0678-4c45-adbf-6f3ecfc94da4 63323-121 HUMAN PRESCRIPTION DRUG Methotrexate METHOTREXATE SODIUM INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20030403 ANDA ANDA040265 Fresenius Kabi USA, LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 63323-122_f33caf6c-6b3f-4beb-8e6c-9aab56e1f170 63323-122 HUMAN PRESCRIPTION DRUG Methotrexate METHOTREXATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20000122 ANDA ANDA040266 Fresenius Kabi USA, LLC METHOTREXATE SODIUM 1 g/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 63323-123_cbf96abd-ef2c-49ea-9c17-95d73cb90980 63323-123 HUMAN PRESCRIPTION DRUG Methotrexate METHOTREXATE SODIUM INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRAVENOUS 20010910 ANDA ANDA040263 Fresenius Kabi USA, LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 63323-125_bc6ffc23-0e65-471a-bb2d-2482e95437c3 63323-125 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110726 ANDA ANDA090799 Fresenius Kabi USA, LLC GEMCITABINE HYDROCHLORIDE 1 g/26.3mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 63323-126_bc6ffc23-0e65-471a-bb2d-2482e95437c3 63323-126 HUMAN PRESCRIPTION DRUG GEMCITABINE GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110516 ANDA ANDA090799 Fresenius Kabi USA, LLC GEMCITABINE HYDROCHLORIDE 2 g/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 63323-130_3d253641-ff9d-4b21-a1ed-6aaa7b2175ec 63323-130 HUMAN PRESCRIPTION DRUG Doxy 100 DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20001017 ANDA ANDA062475 Fresenius Kabi USA, LLC DOXYCYCLINE HYCLATE 100 mg/10mL N 20181231 63323-132_a80eb240-3a6f-4b0d-b8df-e7d6aa5a12d0 63323-132 HUMAN PRESCRIPTION DRUG Mitoxantrone MITOXANTRONE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20060411 ANDA ANDA077496 Fresenius Kabi USA, LLC MITOXANTRONE HYDROCHLORIDE 2 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 63323-136_cc1c6955-a909-4103-bc38-11cc9b96c84e 63323-136 HUMAN PRESCRIPTION DRUG Bleomycin BLEOMYCIN SULFATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20090213 ANDA ANDA065185 Fresenius Kabi USA, LLC BLEOMYCIN SULFATE 15 [USP'U]/1 Cytoprotective Agent [EPC] N 20181231 63323-137_cc1c6955-a909-4103-bc38-11cc9b96c84e 63323-137 HUMAN PRESCRIPTION DRUG Bleomycin BLEOMYCIN SULFATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS 20090213 ANDA ANDA065185 Fresenius Kabi USA, LLC BLEOMYCIN SULFATE 30 [USP'U]/1 Cytoprotective Agent [EPC] N 20181231 63323-140_bf171945-d77a-4e9a-a4f1-de363d946c0f 63323-140 HUMAN PRESCRIPTION DRUG Cladribine CLADRIBINE INJECTION INTRAVENOUS 20041201 ANDA ANDA076571 Fresenius Kabi USA, LLC CLADRIBINE 1 mg/mL Purine Antimetabolite [EPC] N 20181231 63323-142_4c63407f-1190-43b8-9ce8-6d17042874f6 63323-142 HUMAN PRESCRIPTION DRUG Ifosfamide IFOSFAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20030128 ANDA ANDA076078 Fresenius Kabi USA, LLC IFOSFAMIDE 1 g/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 63323-143_3678a067-c132-4bed-b232-0b7448242120 63323-143 HUMAN PRESCRIPTION DRUG Addamel N CHROMIUM, COPPER, IRON, MANGANESE, IODINE, FLUORINE, MOLYBDENUM, SELENIUM, and ZINC INJECTION, SOLUTION INTRAVENOUS 20130507 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Fresenius Kabi USA, LLC CHROMIC CHLORIDE; CUPROUS CHLORIDE; FERRIC CHLORIDE; MANGANESE CHLORIDE; POTASSIUM IODIDE; SODIUM FLUORIDE; SODIUM MOLYBDATE DIHYDRATE; SODIUM SELENITE; ZINC CHLORIDE 1; .13; .11; .027; .013; .095; 1.9; 3.2; .65 ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; mg/mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 63323-145_c27f9bb1-7621-4989-8dba-c8b9fa5503a8 63323-145 HUMAN PRESCRIPTION DRUG Floxuridine FLOXURIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRA-ARTERIAL 20010315 ANDA ANDA075837 Fresenius Kabi USA, LLC FLOXURIDINE 500 mg/5mL Antimetabolite [EPC],Deoxyuridine [Chemical/Ingredient] N 20181231 63323-147_086089e9-b92a-4cd3-9df4-39fbd4ee4704 63323-147 HUMAN PRESCRIPTION DRUG Peditrace ZINC, COPPER, MANGANESE, SELENIUM, FLUORINE, and IODINE INJECTION, SOLUTION INTRAVENOUS 20130509 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Fresenius Kabi USA, LLC ZINC CHLORIDE; CUPRIC CHLORIDE; MANGANESE CHLORIDE; SODIUM SELENITE; SODIUM FLUORIDE; POTASSIUM IODIDE 250; 20; 1; 2; 57; 1 ug/mL; ug/mL; ug/mL; ug/mL; ug/mL; ug/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] N 20181231 63323-151_7efd2b13-cfc2-4b89-8da1-70f6dc25058e 63323-151 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride epirubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20170731 ANDA ANDA065411 Fresenius Kabi USA, LLC EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 63323-161_73678863-e854-4a17-9b89-477fc42cf461 63323-161 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20010905 ANDA ANDA075784 Fresenius Kabi USA, LLC KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 63323-162_73678863-e854-4a17-9b89-477fc42cf461 63323-162 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20001018 ANDA ANDA075784 Fresenius Kabi USA, LLC KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 63323-165_d8c2a75c-9587-4e7d-b1e6-3873302703ed 63323-165 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000907 ANDA ANDA084916 Fresenius Kabi USA, LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63323-170_4bd4e702-5560-4abb-a142-b06940698cb2 63323-170 HUMAN PRESCRIPTION DRUG Sodium Phosphates SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INJECTION, SOLUTION INTRAVENOUS 20000906 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 276; 142 mg/mL; mg/mL N 20181231 63323-172_9869eab0-e03e-42ff-b2a0-8589fa0f3a7e 63323-172 HUMAN PRESCRIPTION DRUG Carboplatin CARBOPLATIN INJECTION, SOLUTION INTRAVENOUS 20091211 ANDA ANDA077266 Fresenius Kabi USA, LLC CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 63323-172_d3210b60-3603-4cae-adaa-1f20a6b673dd 63323-172 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20090915 ANDA ANDA077432 Fresenius Kabi USA, LLC CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 63323-173_a7e217e6-4696-47e6-96cd-7fcef1a0196b 63323-173 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041129 ANDA ANDA062366 Fresenius Kabi USA, LLC GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 63323-178_b45e9f1d-9c48-4b46-8541-d846b89540df 63323-178 HUMAN PRESCRIPTION DRUG Sterile Water Water INJECTION, SOLUTION INTRAVENOUS 20171124 ANDA ANDA209689 Fresenius Kabi USA, LLC WATER 1000 mL/1000mL N 20181231 63323-180_a567701c-2f00-48ce-84eb-7959e85a22cf 63323-180 HUMAN PRESCRIPTION DRUG Pyridoxine Hydrochloride PYRIDOXINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19720814 ANDA ANDA080618 Fresenius Kabi USA, LLC PYRIDOXINE HYDROCHLORIDE 100 mg/mL Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 63323-184_d1a4f664-040d-4c6d-b137-e0a0a9e7bf26 63323-184 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000905 ANDA ANDA089202 Fresenius Kabi USA, LLC FOLIC ACID 5 mg/mL N 20181231 63323-187_fb76dfe1-b526-41fe-99c3-cf8f10a1d41d 63323-187 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000905 UNAPPROVED DRUG OTHER APP Pharmaceuticals, LLC SODIUM CHLORIDE 234 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 63323-192_40c40275-b5a2-4682-9c89-f92f55bb05fb 63323-192 HUMAN PRESCRIPTION DRUG Fludarabine FLUDARABINE PHOSPHATE INJECTION, SOLUTION INTRAVENOUS 20071116 ANDA ANDA078393 Fresenius Kabi USA, LLC FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 63323-193_77d71b99-b25c-47df-bdea-f7a04d132b64 63323-193 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20090401 ANDA ANDA078188 Fresenius Kabi USA, LLC IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 63323-193_e81efff2-382c-41a1-a198-5a9e4e8e220a 63323-193 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20090401 ANDA ANDA077776 Fresenius Kabi USA, LLC IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 63323-194_cfbc325f-e308-4eee-8948-fe7da46c342e 63323-194 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20090811 ANDA ANDA065440 Fresenius Kabi USA, LLC IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 63323-203_d48652f5-71f7-4624-a61c-8a17e0ccb8b9 63323-203 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160817 ANDA ANDA062663 Fresenius Kabi USA, LLC VANCOMYCIN HYDROCHLORIDE 750 mg/15mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 63323-221_d48652f5-71f7-4624-a61c-8a17e0ccb8b9 63323-221 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20000901 ANDA ANDA062663 Fresenius Kabi USA, LLC VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 63323-221_d7fad375-2f75-4ba0-84f7-b3dbc30f6e0d 63323-221 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171101 ANDA ANDA204107 Fresenius Kabi, LLC VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 63323-229_e12eeda5-be91-4386-9c15-d09d4fe4c7b5 63323-229 HUMAN PRESCRIPTION DRUG Protamine Sulfate PROTAMINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20001018 ANDA ANDA089454 Fresenius Kabi USA, LLC PROTAMINE SULFATE 10 mg/mL Heparin Binding Activity [MoA],Heparin Reversal Agent [EPC],Reversed Anticoagulation Activity [PE] N 20181231 63323-236_b5b1fc9a-ba9b-46d9-96ff-36bf116128b8 63323-236 HUMAN PRESCRIPTION DRUG CEFAZOLIN CEFAZOLIN SODIUM POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110715 ANDA ANDA065303 Fresenius Kabi USA, LLC CEFAZOLIN SODIUM 500 mg/2.2mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63323-237_b5b1fc9a-ba9b-46d9-96ff-36bf116128b8 63323-237 HUMAN PRESCRIPTION DRUG CEFAZOLIN CEFAZOLIN SODIUM POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110715 ANDA ANDA065303 Fresenius Kabi USA, LLC CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63323-238_74d9dd37-20ed-4f51-bb70-c3328a10bb7e 63323-238 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin Sodium POWDER, FOR SOLUTION INTRAVENOUS 20110614 ANDA ANDA065306 Fresenius Kabi USA, LLC CEFAZOLIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63323-241_0bc61980-d4a9-4b9a-864b-d4a25cbe49e0 63323-241 HUMAN PRESCRIPTION DRUG Glycophos SODIUM GLYCOLATE INJECTION, SOLUTION INTRAVENOUS; INTRAVENOUS 20130513 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Fresenius Kabi USA, LLC SODIUM GLYCEROPHOSPHATE ANHYDROUS 216 mg/mL N 20181231 63323-249_04adfa5a-4014-43e4-9be7-7e503ed9c0fd 63323-249 HUMAN PRESCRIPTION DRUG Bacteriostatic Water WATER INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20001008 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC WATER 1 mg/mL N 20181231 63323-255_b90540a6-8490-45d8-b5ca-2d2cb7bf47b3 63323-255 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA040583 Fresenius Kabi USA, LLC METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63323-258_b90540a6-8490-45d8-b5ca-2d2cb7bf47b3 63323-258 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA040583 Fresenius Kabi USA, LLC METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63323-261_ddd49274-ab76-4324-be8b-4d7de48ce65a 63323-261 HUMAN PRESCRIPTION DRUG Progesterone PROGESTERONE INJECTION, SOLUTION INTRAMUSCULAR 20010719 ANDA ANDA075906 Fresenius Kabi USA, LLC PROGESTERONE 50 mg/mL Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 63323-262_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-262 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63323-265_b90540a6-8490-45d8-b5ca-2d2cb7bf47b3 63323-265 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA040612 Fresenius Kabi USA, LLC METHYLPREDNISOLONE SODIUM SUCCINATE 1 g/16mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63323-269_1ee3d1c2-3666-4931-8892-bf22927ad057 63323-269 HUMAN PRESCRIPTION DRUG Diprivan PROPOFOL INJECTION, EMULSION INTRAVENOUS 20091113 NDA NDA019627 Fresenius Kabi USA, LLC PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20191231 63323-269_b2b22b4d-d97b-42f9-b8d1-385c972a20da 63323-269 HUMAN PRESCRIPTION DRUG Diprivan PROPOFOL INJECTION, EMULSION INTRAVENOUS 20091113 NDA NDA019627 Fresenius Kabi USA, LLC PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20191231 63323-269_b4e6a40b-958e-447e-9322-1f4e8217f63e 63323-269 HUMAN PRESCRIPTION DRUG Diprivan PROPOFOL INJECTION, EMULSION INTRAVENOUS 20091113 NDA NDA019627 Fresenius Kabi USA, LLC PROPOFOL 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20191231 63323-272_bbb99c8d-79aa-4930-8afa-57f433c90c74 63323-272 HUMAN PRESCRIPTION DRUG Fluphenazine Decanoate FLUPHENAZINE DECANOATE INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20101215 ANDA ANDA071413 Fresenius Kabi USA, LLC FLUPHENAZINE DECANOATE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63323-273_769fcc86-691e-46cd-9d96-ca3a812b4918 63323-273 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate INJECTION SUBCUTANEOUS 20110412 ANDA ANDA079242 Fresenius Kabi USA, LLC SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63323-276_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-276 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63323-278_c87547f1-0b6f-4bb6-b90e-7ff8695ffcdd 63323-278 HUMAN PRESCRIPTION DRUG Vinblastine Sulfate VINBLASTINE SULFATE INJECTION INTRAVENOUS 20000712 ANDA ANDA089515 Fresenius Kabi USA, LLC VINBLASTINE SULFATE 1 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] N 20181231 63323-280_09ae874a-2d61-4da4-88dc-5079fbb2daf4 63323-280 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000712 NDA NDA018902 Fresenius Kabi USA, LLC FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63323-280_3747bbcd-783d-4baa-bb5b-b6827bf390e3 63323-280 HUMAN PRESCRIPTION DRUG Furosemide FUROSEMIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000712 NDA NDA018902 Fresenius Kabi USA, LLC FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63323-281_d066d6b3-db0a-4474-8731-ae0aa29584c3 63323-281 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR 20101228 ANDA ANDA089556 Fresenius Kabi USA, LLC FLUPHENAZINE HYDROCHLORIDE 2.5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63323-282_0303c92f-8410-4f12-b31f-f98ef869ecb4 63323-282 HUMAN PRESCRIPTION DRUG Clindamycin CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION INTRAVENOUS 20091122 ANDA ANDA065346 Fresenius Kabi USA, LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63323-282_051eb7af-918b-43ef-a1d1-40d66e8ffb66 63323-282 HUMAN PRESCRIPTION DRUG Clindamycin CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091122 ANDA ANDA065347 Fresenius Kabi USA, LLC CLINDAMYCIN PHOSPHATE 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63323-284_83ea3faf-fedd-4725-911f-d71a23ec5d5e 63323-284 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20000920 ANDA ANDA062663 Fresenius Kabi USA, LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 63323-284_8f9649c3-aff9-40d8-a708-8d1d67fb7d4b 63323-284 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20000920 ANDA ANDA062663 Fresenius Kabi USA, LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 63323-284_d48652f5-71f7-4624-a61c-8a17e0ccb8b9 63323-284 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20000920 ANDA ANDA062663 Fresenius Kabi USA, LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 63323-284_e66b48d0-2785-4e3f-a582-ef8cecdc3783 63323-284 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171026 ANDA ANDA204107 Fresenius Kabi, LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 63323-285_29c5a950-5cf6-4bc7-9bbb-097aa735d83a 63323-285 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20110531 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 63323-286_29c5a950-5cf6-4bc7-9bbb-097aa735d83a 63323-286 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; PERINEURAL 20110531 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 63323-287_29c5a950-5cf6-4bc7-9bbb-097aa735d83a 63323-287 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; PERINEURAL 20110531 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 63323-288_29c5a950-5cf6-4bc7-9bbb-097aa735d83a 63323-288 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20110531 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 63323-288_fa18a249-fd92-4bf9-82b3-df7c0d2bdf62 63323-288 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION EPIDURAL 20090804 NDA NDA020533 Fresenius Kabi USA, LLC ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20191231 63323-295_7ed59dd7-e8ff-4b22-94ac-edd3d2d21dba 63323-295 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010717 ANDA ANDA062663 Fresenius Kabi USA, LLC VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 63323-300_c4e4dfc9-d755-42a7-8d00-9083643dc669 63323-300 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 Fresenius Kabi USA, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 63323-304_8d3bc2a1-2c14-4282-944c-ef8f2748ffe5 63323-304 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam Piperacillin Sodium and Tazobactam Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20110531 ANDA ANDA090498 Fresenius Kabi USA, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 36; 4.5 g/180mL; g/180mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 63323-305_e605dbf4-347f-4dfd-bc7e-acd6d0862477 63323-305 HUMAN PRESCRIPTION DRUG Tobramycin TOBRAMYCIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20041130 ANDA ANDA065122 Fresenius Kabi USA, LLC TOBRAMYCIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 63323-306_e605dbf4-347f-4dfd-bc7e-acd6d0862477 63323-306 HUMAN PRESCRIPTION DRUG Tobramycin TOBRAMYCIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20051123 ANDA ANDA065122 Fresenius Kabi USA, LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 63323-307_a25f477a-3f7a-4dca-9520-f7d596b6447e 63323-307 HUMAN PRESCRIPTION DRUG Tobramycin TOBRAMYCIN SULFATE INJECTION, SOLUTION INTRAVENOUS 20041130 ANDA ANDA065120 Fresenius Kabi USA, LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 63323-309_c4e4dfc9-d755-42a7-8d00-9083643dc669 63323-309 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 Fresenius Kabi USA, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 63323-311_227abf8b-a495-4cd9-a267-91e079e5490f 63323-311 HUMAN PRESCRIPTION DRUG Calcium Gluconate CALCIUM GLUCONATE INJECTION, SOLUTION INTRAVENOUS 20000809 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC CALCIUM GLUCONATE 94 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 63323-311_3e76a96c-abca-4dfd-9161-3b6031cc9d76 63323-311 HUMAN PRESCRIPTION DRUG Calcium Gluconate CALCIUM GLUCONATE INJECTION, SOLUTION INTRAVENOUS 20000712 UNAPPROVED DRUG OTHER Fresenius Kabi USA, LLC CALCIUM GLUCONATE 94 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 63323-314_348e4fee-250a-4746-b227-afec4f448513 63323-314 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170901 ANDA ANDA204125 Fresenius Kabi, LLC VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 63323-314_7ed59dd7-e8ff-4b22-94ac-edd3d2d21dba 63323-314 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20041130 ANDA ANDA062663 Fresenius Kabi USA, LLC VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 63323-317_98b4b07b-9eed-423e-b457-88a52029acd2 63323-317 HUMAN PRESCRIPTION DRUG Granisetron GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20091120 ANDA ANDA078522 Fresenius Kabi USA, LLC GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63323-318_98b4b07b-9eed-423e-b457-88a52029acd2 63323-318 HUMAN PRESCRIPTION DRUG Granisetron GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20091120 ANDA ANDA078096 Fresenius Kabi USA, LLC GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63323-319_98b4b07b-9eed-423e-b457-88a52029acd2 63323-319 HUMAN PRESCRIPTION DRUG Granisetron GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20091120 ANDA ANDA078090 Fresenius Kabi USA, LLC GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63323-320_c4e4dfc9-d755-42a7-8d00-9083643dc669 63323-320 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam PIPERACILLIN SODIUM,TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091013 ANDA ANDA065523 Fresenius Kabi USA, LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 63323-321_45465165-75f4-4ef5-8d60-b21c0667a9e1 63323-321 HUMAN PRESCRIPTION DRUG Polymyxin B POLYMYXIN B SULFATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20091117 ANDA ANDA065372 Fresenius Kabi USA, LLC POLYMYXIN B SULFATE 500000 [USP'U]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 63323-322_f495f70a-ace1-42ee-8520-6e36977307af 63323-322 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin Imipenem and Cilastatin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120103 ANDA ANDA090577 Fresenius Kabi USA, LLC IMIPENEM; CILASTATIN SODIUM 500; 500 mg/20mL; mg/20mL Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC],Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] E 20171231 63323-325_d0f0fc50-cf59-4963-af54-a1fdc26aaa92 63323-325 HUMAN PRESCRIPTION DRUG Acyclovir ACYCLOVIR SODIUM INJECTION, SOLUTION INTRAVENOUS 20001017 ANDA ANDA074930 Fresenius Kabi USA, LLC ACYCLOVIR SODIUM 50 mg/mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63323-326_bc3813f6-8948-4564-81c8-417a224bd0b3 63323-326 HUMAN PRESCRIPTION DRUG Cefepime Cefepime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100830 ANDA ANDA065441 Fresenius Kabi USA, LLC CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 63323-329_c0a8cd71-a8e2-45c7-9b91-8d96697259ae 63323-329 HUMAN PRESCRIPTION DRUG Bacitracin BACITRACIN INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20030128 ANDA ANDA065116 Fresenius Kabi USA, LLC BACITRACIN 50000 [iU]/1 Decreased Cell Wall Synthesis & Repair [PE] N 20181231 63323-340_bc3813f6-8948-4564-81c8-417a224bd0b3 63323-340 HUMAN PRESCRIPTION DRUG Cefepime Cefepime INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100830 ANDA ANDA065441 Fresenius Kabi USA, LLC CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 63323-341_4379cbe5-6c79-49cf-ad4a-97f4a71f9418 63323-341 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin Sodium POWDER, FOR SOLUTION INTRAVENOUS 20110706 ANDA ANDA065414 Fresenius Kabi USA, LLC CEFOXITIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63323-342_4379cbe5-6c79-49cf-ad4a-97f4a71f9418 63323-342 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin Sodium POWDER, FOR SOLUTION INTRAVENOUS 20110706 ANDA ANDA065414 Fresenius Kabi USA, LLC CEFOXITIN SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63323-343_fe65cbcc-1f0d-439c-a3de-0f0d1e63c1d9 63323-343 HUMAN PRESCRIPTION DRUG Cefoxitin Cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120221 ANDA ANDA065415 Fresenius Kabi USA, LLC CEFOXITIN SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63323-349_f495f70a-ace1-42ee-8520-6e36977307af 63323-349 HUMAN PRESCRIPTION DRUG Imipenem and Cilastatin Imipenem and Cilastatin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20120103 ANDA ANDA090577 Fresenius Kabi USA, LLC IMIPENEM; CILASTATIN SODIUM 250; 250 mg/20mL; mg/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC],Dipeptidase Inhibitors [MoA],Renal Dehydropeptidase Inhibitor [EPC] E 20171231 63323-351_e9a0eaa9-b59a-46b5-a5c8-bf7e2125deea 63323-351 HUMAN PRESCRIPTION DRUG Rifampin RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140821 ANDA ANDA091181 Fresenius Kabi USA, LLC RIFAMPIN 600 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 63323-355_d3dd6c62-93fd-40d3-9fe5-47dbfe75c34f 63323-355 HUMAN PRESCRIPTION DRUG Levofloxacin LEVOFLOXACIN INJECTION INTRAVENOUS 20130620 ANDA ANDA200674 Fresenius Kabi USA, LLC LEVOFLOXACIN 5 mg/mL N 20181231 63323-356_6ae7b3a8-3fa7-4e05-ae2f-ea64a40e7c34 63323-356 HUMAN PRESCRIPTION DRUG Caspofungin Acetate Caspofungin Acetate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20161230 NDA NDA206110 Fresenius Kabi USA, LLC CASPOFUNGIN ACETATE 5 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 63323-358_6ae7b3a8-3fa7-4e05-ae2f-ea64a40e7c34 63323-358 HUMAN PRESCRIPTION DRUG Caspofungin Acetate Caspofungin Acetate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20161230 NDA NDA206110 Fresenius Kabi USA, LLC CASPOFUNGIN ACETATE 7 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 63323-359_d50696cd-0f4c-4ba0-a0bf-3af5159ab17e 63323-359 HUMAN PRESCRIPTION DRUG KANAMYCIN KANAMYCIN INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20030128 ANDA ANDA065111 Fresenius Kabi USA, LLC KANAMYCIN A SULFATE 333 mg/mL N 20181231 63323-360_8b77c3d2-992d-4261-8421-9cfd07328fbf 63323-360 HUMAN PRESCRIPTION DRUG Calcium Gluconate Calcium Gluconate INJECTION, SOLUTION INTRAVENOUS 20170615 NDA NDA208418 Fresenius Kabi USA, LLC CALCIUM GLUCONATE MONOHYDRATE 98 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 63323-365_b2cc3858-5461-4b02-a0ca-559853c3471f 63323-365 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077457 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 63323-367_1d57c007-5019-4f88-a927-4a186c25d912 63323-367 HUMAN PRESCRIPTION DRUG POLYMYXIN B POLYMYXIN B SULFATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20150909 ANDA ANDA202766 Fresenius Kabi USA, LLC POLYMYXIN B SULFATE 500000 [USP'U]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 63323-373_e338df86-2858-4b13-ab02-d3541fa12d0e 63323-373 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20091118 ANDA ANDA076972 Fresenius Kabi USA, LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63323-374_e338df86-2858-4b13-ab02-d3541fa12d0e 63323-374 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20091118 ANDA ANDA076974 Fresenius Kabi USA, LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63323-376_b2cc3858-5461-4b02-a0ca-559853c3471f 63323-376 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077457 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 63323-377_b2cc3858-5461-4b02-a0ca-559853c3471f 63323-377 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077457 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 63323-378_b2cc3858-5461-4b02-a0ca-559853c3471f 63323-378 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077450 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 63323-379_b2cc3858-5461-4b02-a0ca-559853c3471f 63323-379 HUMAN PRESCRIPTION DRUG Octreotide OCTREOTIDE ACETATE INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20060314 ANDA ANDA077450 Fresenius Kabi USA, LLC OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 63323-385_5ce0ad69-19d9-4aea-af77-1b55b6ce5179 63323-385 HUMAN PRESCRIPTION DRUG Cefotetan CEFOTETAN DISODIUM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091118 ANDA ANDA065374 Fresenius Kabi USA, LLC CEFOTETAN DISODIUM 1 g/10mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63323-386_5ce0ad69-19d9-4aea-af77-1b55b6ce5179 63323-386 HUMAN PRESCRIPTION DRUG Cefotetan CEFOTETAN DISODIUM INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091118 ANDA ANDA065374 Fresenius Kabi USA, LLC CEFOTETAN DISODIUM 2 g/20mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63323-393_40ae8d43-e65a-4533-bb94-babdac91d4b8 63323-393 HUMAN PRESCRIPTION DRUG Colistimethate COLISTIMETHATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091204 ANDA ANDA065364 Fresenius Kabi USA, LLC COLISTIMETHATE SODIUM 150 mg/2mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 63323-396_9387a53e-af02-4d46-901c-f72750b977bf 63323-396 HUMAN PRESCRIPTION DRUG Cefotetan CEFOTETAN DISODIUM INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20091203 ANDA ANDA065375 Fresenius Kabi USA, LLC CEFOTETAN DISODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63323-398_23cbdaeb-6dc7-42a8-ac59-fcccd1789c7e 63323-398 HUMAN PRESCRIPTION DRUG Azithromycin AZITHROMYCIN MONOHYDRATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20060320 ANDA ANDA065179 Fresenius Kabi USA, LLC AZITHROMYCIN MONOHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 63323-400_cc41696c-9cf0-4410-bacc-09132ee805ce 63323-400 HUMAN PRESCRIPTION DRUG Levetiracetam LEVETIRACETAM INJECTION, SOLUTION INTRAVENOUS 20150813 ANDA ANDA090876 Fresenius Kabi USA, LLC LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63323-401_e8fb3eb8-39ee-43dc-b0dc-21f79f9b1d3f 63323-401 HUMAN PRESCRIPTION DRUG Aztreonam AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091105 ANDA ANDA065439 Fresenius Kabi USA, LLC AZTREONAM 1 g/1 Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] N 20181231 63323-402_e8fb3eb8-39ee-43dc-b0dc-21f79f9b1d3f 63323-402 HUMAN PRESCRIPTION DRUG Aztreonam AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091105 ANDA ANDA065439 Fresenius Kabi USA, LLC AZTREONAM 2 g/1 Monobactam Antibacterial [EPC],Monobactams [Chemical/Ingredient] N 20181231 63323-403_7778303e-5aac-4ab1-8379-651b19c8f072 63323-403 HUMAN PRESCRIPTION DRUG Fosphenytoin FOSPHENYTOIN SODIUM INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20091214 ANDA ANDA078052 Fresenius Kabi USA, LLC FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 63323-405_a9313fb2-a25f-4b7e-aaad-b1a21fa58a71 63323-405 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20110708 ANDA ANDA200673 Fresenius Kabi USA, LLC CLONIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63323-407_48a3fd6a-db90-41f0-9771-b9c838d6d2c6 63323-407 HUMAN PRESCRIPTION DRUG Caffeine Citrate CAFFEINE CITRATE INJECTION, SOLUTION INTRAVENOUS 20091119 ANDA ANDA077997 Fresenius Kabi USA, LLC CAFFEINE CITRATE 20 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 63323-411_a9689855-69ca-4546-bc8f-e35a2981e88f 63323-411 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 Fresenius Kabi USA, LLC MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63323-412_09daf48f-1d44-4b7b-bb53-bd5635b93ca6 63323-412 HUMAN PRESCRIPTION DRUG Midazolam Midazolam Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170328 ANDA ANDA208878 Fresenius Kabi USA, LLC MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63323-412_a9689855-69ca-4546-bc8f-e35a2981e88f 63323-412 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000710 ANDA ANDA075154 Fresenius Kabi USA, LLC MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63323-413_6448229c-e650-47ba-bb00-cba3604502c5 63323-413 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate INJECTION, SOLUTION INTRAVENOUS 20150108 NDA NDA203629 Fresenius Kabi USA, LLC NEOSTIGMINE METHYLSULFATE .5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 63323-415_6448229c-e650-47ba-bb00-cba3604502c5 63323-415 HUMAN PRESCRIPTION DRUG Neostigmine Methylsulfate Neostigmine Methylsulfate INJECTION, SOLUTION INTRAVENOUS 20150108 NDA NDA203629 Fresenius Kabi USA, LLC NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 63323-416_46e6638a-7ec2-4227-b4f6-7b1f1e091ae1 63323-416 HUMAN PRESCRIPTION DRUG Cisatracurium CISATRACURIUM BESYLATE INJECTION, SOLUTION INTRAVENOUS 20150226 ANDA ANDA203182 Fresenius Kabi USA, LLC CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 63323-417_46e6638a-7ec2-4227-b4f6-7b1f1e091ae1 63323-417 HUMAN PRESCRIPTION DRUG Cisatracurium CISATRACURIUM BESYLATE INJECTION, SOLUTION INTRAVENOUS 20150226 ANDA ANDA203183 Fresenius Kabi USA, LLC CISATRACURIUM BESYLATE 2 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 63323-418_46e6638a-7ec2-4227-b4f6-7b1f1e091ae1 63323-418 HUMAN PRESCRIPTION DRUG Cisatracurium CISATRACURIUM BESYLATE INJECTION, SOLUTION INTRAVENOUS 20150226 ANDA ANDA203182 Fresenius Kabi USA, LLC CISATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 63323-421_df401a81-2baf-4ded-8b27-239e123bc34b 63323-421 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20150918 ANDA ANDA201072 Fresenius Kabi USA, LLC DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 63323-426_e09f6cf2-26aa-4a7f-9a41-fa2d2a9e7709 63323-426 HUMAN PRESCRIPTION DRUG Rocuronium ROCURONIUM BROMIDE INJECTION, SOLUTION INTRAVENOUS 20091213 ANDA ANDA078651 Fresenius Kabi USA, LLC ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 63323-427_a9313fb2-a25f-4b7e-aaad-b1a21fa58a71 63323-427 HUMAN PRESCRIPTION DRUG Clonidine CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20110708 ANDA ANDA200673 Fresenius Kabi USA, LLC CLONIDINE HYDROCHLORIDE 500 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63323-449_74d9dd37-20ed-4f51-bb70-c3328a10bb7e 63323-449 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin Sodium POWDER, FOR SOLUTION INTRAVENOUS 20110614 ANDA ANDA065306 Fresenius Kabi USA, LLC CEFAZOLIN SODIUM 20 g/100mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 63323-459_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-459 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20110425 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63323-461_b4313b7a-a034-4599-ae88-11b93706b5f9 63323-461 HUMAN PRESCRIPTION DRUG SENSORCAINE BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20101119 ANDA ANDA070967 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 2.5; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 63323-469_ec202f27-6a8c-4375-9261-d3f4c845ef2b 63323-469 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate HALOPERIDOL DECANOATE INJECTION INTRAMUSCULAR 20000216 ANDA ANDA074893 Fresenius Kabi USA, LLC HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] N 20181231 63323-471_ec202f27-6a8c-4375-9261-d3f4c845ef2b 63323-471 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate HALOPERIDOL DECANOATE INJECTION INTRAMUSCULAR 20000712 ANDA ANDA074893 Fresenius Kabi USA, LLC HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] N 20181231 63323-473_003494b8-9599-47be-b4b1-5fab2d4434fa 63323-473 HUMAN PRESCRIPTION DRUG Sensorcaine MPF BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION SUBARACHNOID 20100525 ANDA ANDA071202 Fresenius Kabi USA, LLC BUPIVACAINE HYDROCHLORIDE 7.5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] E 20171231 63323-474_c1ff1bd8-05fd-4454-a79a-e1da261f5f36 63323-474 HUMAN PRESCRIPTION DRUG Haloperidol HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20001020 ANDA ANDA075689 Fresenius Kabi USA, LLC HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20181231 63323-475_85b542c0-390d-4939-943a-e37496de7b08 63323-475 HUMAN PRESCRIPTION DRUG Nesacaine CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20101014 NDA NDA009435 Fresenius Kabi USA, LLC CHLOROPROCAINE HYDROCHLORIDE 10 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 63323-476_85b542c0-390d-4939-943a-e37496de7b08 63323-476 HUMAN PRESCRIPTION DRUG Nesacaine CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20101014 NDA NDA009435 Fresenius Kabi USA, LLC CHLOROPROCAINE HYDROCHLORIDE 20 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 63323-477_85b542c0-390d-4939-943a-e37496de7b08 63323-477 HUMAN PRESCRIPTION DRUG Nesacaine MPF CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20101014 NDA NDA009435 Fresenius Kabi USA, LLC CHLOROPROCAINE HYDROCHLORIDE 20 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 63323-478_85b542c0-390d-4939-943a-e37496de7b08 63323-478 HUMAN PRESCRIPTION DRUG Nesacaine MPF CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20101014 NDA NDA009435 Fresenius Kabi USA, LLC CHLOROPROCAINE HYDROCHLORIDE 30 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 63323-494_1d860671-8a34-4ebb-8569-04721d9fc3ff 63323-494 HUMAN PRESCRIPTION DRUG Valproate Sodium VALPROATE SODIUM INJECTION, SOLUTION INTRAVENOUS 20030818 ANDA ANDA076539 Fresenius Kabi USA, LLC VALPROATE SODIUM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63323-494_3dfb6da1-f66a-4618-9f74-d2d6c16c0b58 63323-494 HUMAN PRESCRIPTION DRUG Valproate Sodium VALPROATE SODIUM INJECTION, SOLUTION INTRAVENOUS 20030818 ANDA ANDA076539 Fresenius Kabi USA, LLC VALPROATE SODIUM 100 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63323-505_ccec1a48-d2f4-4130-93d9-d68502321b1d 63323-505 HUMAN PRESCRIPTION DRUG Sodium Citrate Blood-Pack Units, (PL 146 Plastic) Anticoagulant Sodium Citrate Solution SOLUTION INTRAVENOUS 20140929 NDA BN770923 Fresenius Kabi USA, LLC TRISODIUM CITRATE DIHYDRATE 4 g/100mL Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 63323-506_728c68a3-4ed0-4ae2-a451-ed6212bcc972 63323-506 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20030529 ANDA ANDA040491 Fresenius Kabi USA, LLC DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63323-507_b01ad320-e81c-4269-b1ff-9709323bc04d 63323-507 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111014 ANDA ANDA091404 Fresenius Kabi USA, LLC MEROPENEM 500 mg/10mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] E 20171231 63323-508_b01ad320-e81c-4269-b1ff-9709323bc04d 63323-508 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20111026 ANDA ANDA091404 Fresenius Kabi USA, LLC MEROPENEM 1 g/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] E 20171231 63323-513_aaaa0c22-58d6-4cf8-a992-425e5ff39e79 63323-513 HUMAN PRESCRIPTION DRUG Gentamicin GENTAMICIN SULFATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19820304 ANDA ANDA062356 Fresenius Kabi USA, LLC GENTAMICIN SULFATE 10 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 63323-516_728c68a3-4ed0-4ae2-a451-ed6212bcc972 63323-516 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050405 ANDA ANDA040572 Fresenius Kabi USA, LLC DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63323-517_f0c3c423-34ab-44dc-bb2a-d40c93c60ff6 63323-517 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20170824 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 10000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63323-518_f0c3c423-34ab-44dc-bb2a-d40c93c60ff6 63323-518 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20170824 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 5000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63323-522_f0c3c423-34ab-44dc-bb2a-d40c93c60ff6 63323-522 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20170824 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 5000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63323-523_f0c3c423-34ab-44dc-bb2a-d40c93c60ff6 63323-523 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS 20170824 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 10000 [USP'U]/100mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63323-526_1b688a00-3016-48b8-ae8a-a1e900334d7d 63323-526 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION, SOLUTION INTRAVENOUS 20150323 NDA NDA201811 Fresenius Kabi USA, LLC ARGATROBAN 100 mg/mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 63323-540_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-540 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63323-542_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-542 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63323-543_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-543 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20101203 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 5000 [USP'U]/.5mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63323-562_b195f578-060d-4ad0-842f-70853fbfdb6e 63323-562 HUMAN PRESCRIPTION DRUG Bivalirudin Bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20161028 ANDA ANDA090189 Fresenius Kabi USA, LLC BIVALIRUDIN 250 mg/1 Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 63323-563_6c0b8d78-6cee-4534-badf-a4ade699660c 63323-563 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20120524 ANDA ANDA091596 Fresenius Kabi USA, LLC TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 63323-572_171fac5c-1ab6-47d5-87d5-d23171f33cbd 63323-572 HUMAN PRESCRIPTION DRUG CLOFARABINE clofarabine INJECTION INTRAVENOUS 20170510 ANDA ANDA204029 Fresenius-Kabi CLOFARABINE 1 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 63323-578_54458620-d888-4df6-ae4b-78c3dfed3423 63323-578 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171027 ANDA ANDA209328 Fresenius Kabi USA, LLC GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 63323-593_cc829cfc-5792-4216-bb90-8bb1fd2e95cc 63323-593 HUMAN PRESCRIPTION DRUG Glucagon Glucagon KIT 20151201 NDA NDA201849 Fresenius Kabi USA, LLC N 20181231 63323-596_cc829cfc-5792-4216-bb90-8bb1fd2e95cc 63323-596 HUMAN PRESCRIPTION DRUG Glucagon Glucagon INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150508 NDA NDA201849 Fresenius Kabi USA, LLC GLUCAGON HYDROCHLORIDE 1 mg/mL Antihypoglycemic Agent [EPC],Gastrointestinal Motility Inhibitor [EPC],Increased Gluconeogenesis [PE],Increased Glycogenolysis [PE],Decreased GI Smooth Muscle Tone [PE],Decreased GI Motility [PE],Decreased Glycolysis [PE] N 20181231 63323-597_ec269364-6ff9-47df-b5ad-38922b2180d5 63323-597 HUMAN PRESCRIPTION DRUG Deferoxamine DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20091215 ANDA ANDA078718 Fresenius Kabi USA, LLC DEFEROXAMINE MESYLATE 95 mg/mL Iron Chelating Activity [MoA],Iron Chelator [EPC] N 20181231 63323-599_ec269364-6ff9-47df-b5ad-38922b2180d5 63323-599 HUMAN PRESCRIPTION DRUG Deferoxamine DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20091215 ANDA ANDA078718 Fresenius Kabi USA, LLC DEFEROXAMINE MESYLATE 95 mg/mL Iron Chelating Activity [MoA],Iron Chelator [EPC] N 20181231 63323-614_44a02a8c-7f29-443f-b733-f0b5a97f9497 63323-614 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride HYDRALAZINE HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20010905 ANDA ANDA040388 Fresenius Kabi USA, LLC HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 63323-617_51198ebd-2896-438a-ba9d-db32aa171bf2 63323-617 HUMAN PRESCRIPTION DRUG Milrinone Lactate MILRINONE LACTATE INJECTION, SOLUTION INTRAVENOUS 20020801 ANDA ANDA075936 Fresenius Kabi USA, LLC MILRINONE LACTATE 1 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 63323-623_2a168686-9085-41e5-b098-23868e649911 63323-623 HUMAN PRESCRIPTION DRUG Sodium chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20170919 ANDA ANDA207310 Fresenius Kabi USA, LLC SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 63323-623_5f0e3260-d0fa-452e-941d-2962379c3d91 63323-623 HUMAN PRESCRIPTION DRUG Sodium Chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAVENOUS 20140218 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Fresenius Kabi USA, LLC SODIUM CHLORIDE 9 mg/mL N 20181231 63323-624_008617d7-af80-4ecf-986b-5479b92be7a4 63323-624 HUMAN PRESCRIPTION DRUG Dextrose Dextrose Monohydrate INJECTION, SOLUTION INTRAVENOUS 20161021 ANDA ANDA207449 Fresenius Kabi USA, LLC DEXTROSE MONOHYDRATE 50 mg/mL N 20181231 63323-642_77f70e00-3934-4fd9-a581-4cf3df8c42d2 63323-642 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160129 NDA NDA019316 Fresenius Kabi USA, LLC MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 63323-648_2fb52aa0-d533-4029-9d1c-213b727171ca 63323-648 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110624 NDA NDA202231 Fresenius Kabi USA, LLC LEVOTHYROXINE SODIUM ANHYDROUS 500 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63323-649_2fb52aa0-d533-4029-9d1c-213b727171ca 63323-649 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium LEVOTHYROXINE SODIUM ANHYDROUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110624 NDA NDA202231 Fresenius Kabi USA, LLC LEVOTHYROXINE SODIUM ANHYDROUS 100 ug/5mL l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63323-651_3448641f-36a1-41e0-88b9-e71dfc936bad 63323-651 HUMAN PRESCRIPTION DRUG Adenosine ADENOSINE INJECTION, SOLUTION INTRAVENOUS 20051123 ANDA ANDA077133 Fresenius Kabi USA, LLC ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 63323-652_fbf4b351-9acf-4691-8e6b-0b95fcf6126e 63323-652 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20041130 ANDA ANDA076573 Fresenius Kabi USA, LLC ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63323-658_2c482eda-8793-4bf5-80af-69cd10e7ff26 63323-658 HUMAN PRESCRIPTION DRUG Chlorothiazide CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091021 ANDA ANDA090896 Fresenius Kabi USA, LLC CHLOROTHIAZIDE SODIUM 500 mg/18mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63323-659_52ef7d89-ba18-417a-ad57-bff74335189e 63323-659 HUMAN PRESCRIPTION DRUG Indomethacin INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100319 NDA NDA022536 Fresenius Kabi USA, LLC INDOMETHACIN 1 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63323-660_0beadb2e-c866-4124-81ca-287533580137 63323-660 HUMAN PRESCRIPTION DRUG Metoprolol METOPROLOL TARTRATE INJECTION, SOLUTION INTRAVENOUS 20101028 ANDA ANDA091045 Fresenius Kabi USA, LLC METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63323-665_be203fdb-578c-49a1-8a77-b15b80377d75 63323-665 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate TERBUTALINE SULFATE INJECTION, SOLUTION SUBCUTANEOUS 20110310 ANDA ANDA076887 APP Pharmaceuticals, LLC TERBUTALINE SULFATE 1 mg/mL N 20181231 63323-690_2a60353b-9a4f-4bc8-8690-77ea688b7ea7 63323-690 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20120901 ANDA ANDA203853 Fresenius Kabi USA, LLC ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] E 20171231 63323-691_2a60353b-9a4f-4bc8-8690-77ea688b7ea7 63323-691 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20140331 ANDA ANDA204674 Fresenius Kabi USA, LLC ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] E 20171231 63323-692_2a60353b-9a4f-4bc8-8690-77ea688b7ea7 63323-692 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20120901 ANDA ANDA203853 Fresenius Kabi USA, LLC ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] E 20171231 63323-693_2a60353b-9a4f-4bc8-8690-77ea688b7ea7 63323-693 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20140331 ANDA ANDA204674 Fresenius Kabi USA, LLC ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] E 20171231 63323-694_2a60353b-9a4f-4bc8-8690-77ea688b7ea7 63323-694 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20120901 ANDA ANDA203853 Fresenius Kabi USA, LLC ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] E 20171231 63323-695_2a60353b-9a4f-4bc8-8690-77ea688b7ea7 63323-695 HUMAN PRESCRIPTION DRUG Acetylcysteine ACETYLCYSTEINE SOLUTION ORAL; RESPIRATORY (INHALATION) 20140331 ANDA ANDA204674 Fresenius Kabi USA, LLC ACETYLCYSTEINE 100 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] E 20171231 63323-704_e3aabad3-1129-43be-88f6-df9181bab284 63323-704 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Fresenius Kabi USA, LLC AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63323-705_e3aabad3-1129-43be-88f6-df9181bab284 63323-705 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19710303 ANDA ANDA061395 Fresenius Kabi USA, LLC AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63323-707_e3aabad3-1129-43be-88f6-df9181bab284 63323-707 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Fresenius Kabi USA, LLC AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63323-708_e3aabad3-1129-43be-88f6-df9181bab284 63323-708 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19710303 ANDA ANDA061395 Fresenius Kabi USA, LLC AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 63323-710_8822f46b-c8e1-4089-976f-956b9cb6210f 63323-710 HUMAN PRESCRIPTION DRUG Leucovorin Calcium LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100918 ANDA ANDA040258 Fresenius Kabi USA, LLC LEUCOVORIN CALCIUM 200 mg/20mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 63323-711_8822f46b-c8e1-4089-976f-956b9cb6210f 63323-711 HUMAN PRESCRIPTION DRUG Leucovorin Calcium LEUCOVORIN CALCIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100918 ANDA ANDA040286 Fresenius Kabi USA, LLC LEUCOVORIN CALCIUM 500 mg/50mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 63323-712_33ff0bd9-3105-45e9-826b-47a4b78eea04 63323-712 HUMAN PRESCRIPTION DRUG Kabiven Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine INJECTION, EMULSION INTRAVENOUS 20140825 NDA NDA200656 Fresenius Kabi USA, LLC DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; HISTIDINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE 9.8; 3.9; 239; 174; 147; 96; 29; 263; 231; 231; 213; 164; 164; 164; 55; 467; 330; 231; 199; 199; 164; 131; 99; 6.7 g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Lipid Emulsion [EPC],Lipids [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 63323-713_ed294478-8c3e-45e4-ac45-303fd6e3e5fd 63323-713 HUMAN PRESCRIPTION DRUG Linezolid Linezolid INJECTION, SOLUTION INTRAVENOUS 20150622 ANDA ANDA204764 Fresenius Kabi USA, LLC LINEZOLID 2 mg/mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 63323-714_bb8c68bf-7444-4e7c-a56a-89ad85d11af3 63323-714 HUMAN PRESCRIPTION DRUG Perikabiven Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine INJECTION, EMULSION INTRAVENOUS 20140825 NDA NDA200656 Fresenius Kabi USA, LLC DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; HISTIDINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE 6.8; 3.5; 170; 174; 105; 68; 20; 187; 164; 164; 152; 116; 116; 116; 40; 333; 235; 164; 141; 141; 116; 94; 71; 4.8 g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL Lipid Emulsion [EPC],Lipids [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Amino Acid [EPC],Amino Acids [Chemical/Ingredient] N 20181231 63323-721_5620c54f-596e-4f92-87b0-bd6f4b55a019 63323-721 HUMAN PRESCRIPTION DRUG Bortezomib Bortezomib INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171106 NDA NDA205004 Fresenius Kabi USA, LLC BORTEZOMIB 1 mg/mL Proteasome Inhibitor [EPC],Proteasome Inhibitors [MoA] N 20181231 63323-723_de8baeaa-50b8-4c1d-8dce-948008227bd7 63323-723 HUMAN PRESCRIPTION DRUG Remifentanil Hydrochloride Remifentanil Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20180119 ANDA ANDA206223 Fresenius Kabi USA, LLC REMIFENTANIL HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 63323-724_de8baeaa-50b8-4c1d-8dce-948008227bd7 63323-724 HUMAN PRESCRIPTION DRUG Remifentanil Hydrochloride Remifentanil Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20180119 ANDA ANDA206223 Fresenius Kabi USA, LLC REMIFENTANIL HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 63323-725_de8baeaa-50b8-4c1d-8dce-948008227bd7 63323-725 HUMAN PRESCRIPTION DRUG Remifentanil Hydrochloride Remifentanil Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20180119 ANDA ANDA206223 Fresenius Kabi USA, LLC REMIFENTANIL HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 63323-733_f7fb81c2-ba28-439c-a644-f6f36ea6dc0a 63323-733 HUMAN PRESCRIPTION DRUG Mesna MESNA INJECTION, SOLUTION INTRAVENOUS 20010905 ANDA ANDA075811 Fresenius Kabi USA, LLC MESNA 100 mg/mL Cytoprotective Agent [EPC] N 20181231 63323-734_80ed4c20-1e43-4fe2-bfd9-64652ba75471 63323-734 HUMAN PRESCRIPTION DRUG Pamidronate Disodium PAMIDRONATE DISODIUM INJECTION, SOLUTION INTRAVENOUS 20020519 ANDA ANDA076207 APP Pharmaceuticals, LLC PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 63323-735_80ed4c20-1e43-4fe2-bfd9-64652ba75471 63323-735 HUMAN PRESCRIPTION DRUG Pamidronate Disodium PAMIDRONATE DISODIUM INJECTION, SOLUTION INTRAVENOUS 20020519 ANDA ANDA076207 APP Pharmaceuticals, LLC PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 63323-738_89cc1542-94a1-4f30-8eb5-70ebe7e94abc 63323-738 HUMAN PRESCRIPTION DRUG Famotidine FAMOTIDINE INJECTION, SOLUTION INTRAVENOUS 20010719 ANDA ANDA075709 Fresenius Kabi USA, LLC FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63323-750_1e637855-7c4f-478d-8880-78e0da3cf9d5 63323-750 HUMAN PRESCRIPTION DRUG oxaliplatin oxaliplatin INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20100611 ANDA ANDA078811 Fresenius Kabi USA, LLC OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] E 20171231 63323-762_d6a8d10e-3e84-4125-8256-871391e0ad37 63323-762 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20101130 ANDA ANDA091089 Fresenius Kabi USA, LLC TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 63323-763_20408c51-039d-47de-913d-d719f1cfa98b 63323-763 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20090320 ANDA ANDA077574 Fresenius Kabi USA, LLC PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 63323-763_93252249-15cd-43ae-8d8c-c381b653fb6d 63323-763 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20140815 ANDA ANDA090130 Fresenius Kabi USA, LLC PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 63323-771_3b594aba-e798-4105-b801-0b0d970747c1 63323-771 HUMAN PRESCRIPTION DRUG Azacitidine Azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20170316 ANDA ANDA207518 Fresenius Kabi USA, LLC AZACITIDINE 100 mg/30mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 63323-772_7e0f6b72-8dd3-4f6d-ad16-80401fb8aba1 63323-772 HUMAN PRESCRIPTION DRUG LETROZOLE LETROZOLE TABLET, FILM COATED ORAL 20110604 ANDA ANDA090491 APP Pharmaceuticals, LLC LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 63323-781_d3163bdf-f163-41b5-a38a-3cd6fc1a50ba 63323-781 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160630 ANDA ANDA205390 Fresenius Kabi USA, LLC VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 63323-782_d3163bdf-f163-41b5-a38a-3cd6fc1a50ba 63323-782 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160630 ANDA ANDA205390 Fresenius Kabi USA, LLC VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 63323-815_502ddebd-3300-45bb-a570-8fc5b7148e8d 63323-815 HUMAN PRESCRIPTION DRUG Amikacin Sulfate Amikacin Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151209 ANDA ANDA205604 Fresenius Kabi USA, LLC AMIKACIN SULFATE 250 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20191231 63323-820_4edbe30a-f48e-44f1-a576-869ce8905f04 63323-820 HUMAN PRESCRIPTION DRUG Smoflipid Smoflipid INJECTION, EMULSION INTRAVENOUS 20160713 NDA NDA207648 Fresenius Kabi USA, LLC SOYBEAN OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; FISH OIL 6; 6; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL Lipid Emulsion [EPC],Lipids [Chemical/Ingredient],Lipid Emulsion [EPC],Lipids [Chemical/Ingredient] N 20181231 63323-850_a23c58f0-408e-47d1-829f-5468c519ebd3 63323-850 HUMAN PRESCRIPTION DRUG Moxifloxacin MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20150318 NDA NDA205572 Fresenius Kabi USA, LLC MOXIFLOXACIN HYDROCHLORIDE 400 mg/250mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63323-851_e034eb96-03e0-46e1-8b92-5e1f94555e7b 63323-851 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20171215 NDA NDA019034 Fresenius Kabi USA, LLC HYDROMORPHONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63323-852_e034eb96-03e0-46e1-8b92-5e1f94555e7b 63323-852 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20171215 NDA NDA019034 Fresenius Kabi USA, LLC HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63323-853_e034eb96-03e0-46e1-8b92-5e1f94555e7b 63323-853 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20171215 NDA NDA019034 Fresenius Kabi USA, LLC HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63323-854_e034eb96-03e0-46e1-8b92-5e1f94555e7b 63323-854 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20171215 NDA NDA019034 Fresenius Kabi USA, LLC HYDROMORPHONE HYDROCHLORIDE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63323-871_dc7e3d25-8de1-4a96-aa08-ae2d2ebbe8f7 63323-871 HUMAN PRESCRIPTION DRUG Daptomycin Daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160628 ANDA ANDA206005 Fresenius Kabi USA, LLC DAPTOMYCIN 500 mg/10mL Lipopeptide Antibacterial [EPC],Lipopeptides [Chemical/Ingredient] E 20171231 63323-877_9d14a7f6-afab-40d6-b3d2-4ebe8bed0605 63323-877 HUMAN PRESCRIPTION DRUG NebuPent PENTAMIDINE ISETHIONATE INHALANT RESPIRATORY (INHALATION) 20110215 NDA NDA019887 Fresenius Kabi USA, LLC PENTAMIDINE ISETHIONATE 300 mg/6mL Antiprotozoal [EPC] N 20181231 63323-883_f48b1ac2-923f-4825-9c44-02df9253cf96 63323-883 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20000414 ANDA ANDA063277 Fresenius Kabi USA, LLC DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 63323-915_3bbce5c9-3dd0-4675-9a87-a2d786b435e6 63323-915 HUMAN PRESCRIPTION DRUG Heparin Sodium HEPARIN SODIUM INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20100618 NDA NDA017029 Fresenius Kabi USA, LLC HEPARIN SODIUM 20000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63323-924_53233ea2-a9bb-47b6-8112-644d770db625 63323-924 HUMAN PRESCRIPTION DRUG Bacteriostatic Sodium Chloride SODIUM CHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20000808 ANDA ANDA088911 APP Pharmaceuticals, LLC SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 63323-942_65a657b8-f9d4-4a80-8ce5-d6e58b59b916 63323-942 HUMAN PRESCRIPTION DRUG Palonosetron Palonosetron INJECTION, SOLUTION INTRAVENOUS 20170601 NDA NDA208109 Fresenius Kabi USA, LLC PALONOSETRON HYDROCHLORIDE .25 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63323-960_63c582cb-f172-400a-86ae-93b25062c0b6 63323-960 HUMAN PRESCRIPTION DRUG Tigecycline Tigecycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20161201 NDA NDA205645 Fresenius Kabi USA, LLC TIGECYCLINE 50 mg/5mL Tetracycline-class Antibacterial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 63323-961_c9d01338-923a-4b9d-a241-529b57a57cbc 63323-961 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION INTRAVENOUS 20140904 ANDA ANDA202923 Fresenius Kabi USA, LLC ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 63323-963_0c13eb89-0cad-7352-e054-00144ff88e88 63323-963 HUMAN PRESCRIPTION DRUG Acetylcysteine Acetylcysteine INJECTION, SOLUTION INTRAVENOUS 20121109 ANDA ANDA200644 Fresenius Kabi USA, LLC ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] E 20171231 63323-965_904c7604-8bbc-4f22-a923-38c1513ba80a 63323-965 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 19990927 ANDA ANDA088901 APP Pharmaceuticals, LLC POTASSIUM CHLORIDE 2 meq/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 63323-966_16fcf8c9-ef8a-4e93-9ee6-acfadd35a861 63323-966 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20170217 ANDA ANDA204217 Fresenius Kabi USA, LLC ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 63323-967_904c7604-8bbc-4f22-a923-38c1513ba80a 63323-967 HUMAN PRESCRIPTION DRUG Potassium Chloride POTASSIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20000905 ANDA ANDA088908 APP Pharmaceuticals, LLC POTASSIUM CHLORIDE 2 meq/mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 63323-970_d1b15d36-2bea-4c2e-a14a-5a79f65823dc 63323-970 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110531 ANDA ANDA090233 Fresenius Kabi USA, LLC BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 63347-112_28c7c78b-ffa1-4cd4-93c8-3c90e6f55d35 63347-112 HUMAN OTC DRUG RevitaDERM PSORIASIS COAL TAR OINTMENT TOPICAL 20111101 OTC MONOGRAPH FINAL part358H Blaine Labs Inc. COAL TAR 2 mL/100mL N 20181231 63347-120_de1407a9-5a7b-4a76-9e7b-98d02f06b8f4 63347-120 HUMAN OTC DRUG RevitaDERM Wound Care BENZALKONIUM CHLORIDE GEL TOPICAL 20120524 OTC MONOGRAPH NOT FINAL part333A Blaine Labs Inc. BENZALKONIUM CHLORIDE 170 mg/89mL N 20181231 63347-200_d087296e-1ade-4921-84b8-b0598bace34f 63347-200 HUMAN OTC DRUG Antifungal UNDECYLENIC ACID CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 4.8 mg/36.97mL N 20181231 63347-205_e7be4b93-364c-4380-ba4e-9b1385e9a63b 63347-205 HUMAN OTC DRUG Athletes Foot UNDECYLENIC ACID CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 14.77 mg/59.148mL N 20181231 63347-215_f7acebc9-ed03-4246-aff1-45d5fadd667a 63347-215 HUMAN OTC DRUG Pain Relieving MENTHOL, CAMPHOR GEL TOPICAL 20160401 OTC MONOGRAPH FINAL part341 Blaine Labs Inc. MENTHOL; CAMPHOR (SYNTHETIC) 3.5; .2 mg/100mL; mg/100mL N 20181231 63347-301_2ecfeef1-8736-42e8-b6bf-80b77d8d14b3 63347-301 HUMAN OTC DRUG EuCutaSol COAL TAR CREAM TOPICAL 20120701 OTC MONOGRAPH FINAL part358H Blaine Labs Inc. COAL TAR 2 g/100g N 20181231 63347-401_94bad38f-5516-411b-bf5b-4c236b6fde7a 63347-401 HUMAN OTC DRUG Ortho-Nesic With Capsaicin Menthol GEL TOPICAL 19950101 OTC MONOGRAPH FINAL part341 Blaine Labs Inc. MENTHOL; CAMPHOR (SYNTHETIC) 3.5; .2 g/100g; g/100g N 20181231 63347-415_abb7110b-c9b0-4041-b796-f4232acf551f 63347-415 HUMAN OTC DRUG DANCERS SELECT MENTHOL, CAMPHOR GEL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part348 Blaine Labs Inc. MENTHOL; CAMPHOR (SYNTHETIC) 3.1; .18 mg/88.7mL; min/88.7mL N 20181231 63347-500_63608a75-73ca-4c1d-af57-b991e6fa70d4 63347-500 HUMAN OTC DRUG Tineacide Undecylenic Acid CREAM TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 10 g/100g N 20181231 63347-501_63608a75-73ca-4c1d-af57-b991e6fa70d4 63347-501 HUMAN OTC DRUG Tineacide Physician Formula UNDECYLENIC ACID CREAM TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 13 g/100g N 20181231 63347-502_786abfbd-0a1d-4d6e-be32-e7911d1e34dc 63347-502 HUMAN OTC DRUG TINEACIDE Antifungal MICONAZOLE NITRATE CREAM TOPICAL 20130601 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. MICONAZOLE NITRATE .7 g/35g N 20181231 63347-511_7b053816-3736-4198-99e5-e35813836262 63347-511 HUMAN OTC DRUG TINEACIDE TOLNAFTATE LIQUID TOPICAL 20120919 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. TOLNAFTATE 140 mg/15mL N 20181231 63347-520_93873bbf-6eae-4ce4-9a98-b9eeb69bdc77 63347-520 HUMAN OTC DRUG Tinaacide Athletes Foot UNDECYLENIC ACID CREAM TOPICAL 20120801 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 25 g/100g N 20181231 63347-600_8805548f-fbc5-4013-ab04-ceaef3c73db1 63347-600 HUMAN OTC DRUG TERPENICOL ANTIFUNGAL UNDECYLENIC ACID LIQUID TOPICAL 20140401 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 25 g/100mL N 20181231 63347-601_c85be31f-894e-41de-a751-e10a4950d8fb 63347-601 HUMAN OTC DRUG TERPENICOL UNDECYLENIC ACID CREAM TOPICAL 20170619 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 4.55 g/37.5mL N 20181231 63347-700_896b4f1e-2472-4d78-9900-677a4be27fab 63347-700 HUMAN OTC DRUG Verucide Physician Formula Salicyllic Acid LIQUID TOPICAL 20100101 OTC MONOGRAPH FINAL part358F Blaine Labs Inc. SALICYLIC ACID 17 mL/10mL N 20181231 63347-800_3d70a928-845b-47fe-a9d7-f4595e8fa72e 63347-800 HUMAN OTC DRUG Vite20 UNDECYLENIC ACID CREAM TOPICAL 20120201 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 2 mL/20mL N 20181231 63347-810_ea68d245-166e-4f7a-bb62-13cc6854a0f5 63347-810 HUMAN OTC DRUG Vite20 MICONAZOLE NITRATE LIQUID TOPICAL 20160401 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. MICONAZOLE NITRATE .3 mg/15mL N 20181231 63354-001_643c11ac-3188-4433-abb5-b7b2f0d528ae 63354-001 HUMAN OTC DRUG Banana Boat Natural Reflect Sunscreen SPF 50 Plus TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20111228 OTC MONOGRAPH FINAL part352 Energizer Personal Care LLC TITANIUM DIOXIDE; ZINC OXIDE 2.8; 4 mL/100mL; mL/100mL N 20181231 63354-002_c04bb279-fd16-4ca3-896c-c1ac8e75ea94 63354-002 HUMAN OTC DRUG Banana Boat Natural Reflect Sunscreen BABY SPF 50 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20111228 OTC MONOGRAPH FINAL part352 Energizer Personal Care LLC TITANIUM DIOXIDE; ZINC OXIDE 3.1; 4 mL/100mL; mL/100mL N 20181231 63354-003_2276a7f8-f758-44b6-a582-57e3283ffb8a 63354-003 HUMAN OTC DRUG Banana Boat Natural Reflect Sunscreen KIDS SPF 50 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20111228 OTC MONOGRAPH FINAL part352 Energizer Personal Care LLC TITANIUM DIOXIDE; ZINC OXIDE 3.1; 4 mL/100mL; mL/100mL N 20181231 63354-010_53064e55-f32b-49c2-e054-00144ff8d46c 63354-010 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 6 g/100g; g/100g; g/100g; g/100g N 20181231 63354-028_624281af-9336-4df8-8d75-cb5dcdc2f9aa 63354-028 HUMAN OTC DRUG Meijer AVOBENZONE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE .5; 2; 1.5 mL/100mL; mL/100mL; mL/100mL N 20181231 63354-031_53065e58-d620-3143-e054-00144ff88e88 63354-031 HUMAN OTC DRUG BANANA BOAT octinoxate, padimate o OIL TOPICAL 20100928 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTINOXATE; PADIMATE O 2; 1.4 g/100g; g/100g N 20181231 63354-040_52f1d47a-9c80-5b61-e054-00144ff88e88 63354-040 HUMAN OTC DRUG HAWAIIAN TROPIC avobenzone, octocrylene, oxybenzone AEROSOL TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; AVOBENZONE; OXYBENZONE 3.5; .5; 1.5 g/100g; g/100g; g/100g N 20181231 63354-050_25dd66a4-364e-4207-e054-00144ff88e88 63354-050 HUMAN OTC DRUG Banana Boat Baby SPF 50 Titanium Dioxide,Zinc Oxide LOTION TOPICAL 20140409 OTC MONOGRAPH FINAL part352 EDGEWELL PERSONAL CARE BRANDS LLC TITANIUM DIOXIDE; ZINC OXIDE 3.2; 4 g/100g; g/100g N 20181231 63354-050_4e00f3f0-eaa9-4a56-bc2b-85058ffc5812 63354-050 HUMAN PRESCRIPTION DRUG BANANA BOAT TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20121003 OTC MONOGRAPH NOT FINAL part352 Energizer Personal Care LLC TITANIUM DIOXIDE; ZINC OXIDE 3.1; 4 g/100g; g/100g N 20181231 63354-051_5d1652f1-a23b-059c-e053-2991aa0adde5 63354-051 HUMAN OTC DRUG BANANA BOAT TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20121004 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care LLC TITANIUM DIOXIDE; ZINC OXIDE 3.1; 4 g/100g; g/100g N 20181231 63354-070_60b2e090-a56a-c40d-e053-2a91aa0a4ab4 63354-070 HUMAN OTC DRUG Banana Boat AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE SPRAY TOPICAL 20150219 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 3; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 63354-080_5cf258d5-bc33-a8a1-e053-2991aa0aeb42 63354-080 HUMAN OTC DRUG Banana Boat SunComfort SPF 30 Banana Boat SunComfort SPF 30 SPRAY TOPICAL 20150218 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 2; 7; 1.5; 3 g/100g; g/100g; g/100g; g/100g N 20181231 63354-101_5d062451-ad5d-29d7-e053-2a91aa0a2d77 63354-101 HUMAN OTC DRUG HAWAIIAN TROPIC SPF 15 avobenzone,octisalate,octocrylene LOTION TOPICAL 20140723 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; AVOBENZONE; OCTISALATE 2; 1.5; 3 g/100g; g/100g; g/100g N 20181231 63354-110_5f0ea271-0a39-1756-e053-2991aa0a0c9c 63354-110 HUMAN OTC DRUG Banana Boat avobenzone, octocrylene, oxybenzone LOTION TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 3; 6; 4 g/100g; g/100g; g/100g N 20181231 63354-115_53065e58-d640-3143-e054-00144ff88e88 63354-115 HUMAN OTC DRUG BANANA BOAT KIDS FREE 50 BANANA BOAT KIDS FREE 50 SPRAY TOPICAL 20150108 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE 5; 6; 3; 10 g/100g; g/100g; g/100g; g/100g N 20181231 63354-121_5d04d97b-2845-2e58-e053-2a91aa0a03d6 63354-121 HUMAN OTC DRUG Hawaiian Tropic octocrylene, oxybenzone OIL TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; OXYBENZONE 2; 4 g/100g; g/100g N 20181231 63354-129_5cf2314e-2cdc-33b3-e053-2991aa0a7b7c 63354-129 HUMAN OTC DRUG Banana Boat Avobenzone Homosalate Octisalate Octocrylene Oxybenzone SPRAY TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE; HOMOSALATE 5; 10; 6; 3; 10 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 63354-139_53063cb4-a2c1-4a2a-e054-00144ff8d46c 63354-139 HUMAN OTC DRUG Banana Boat Avobenzone, Homosalate, Octocrylene LOTION TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE 1.4; 3; 3 g/100g; g/100g; g/100g N 20181231 63354-140_53061fde-27a2-285a-e054-00144ff88e88 63354-140 HUMAN OTC DRUG BANANA BOAT avobenzone, octocrylene, oxybenzone STICK TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OXYBENZONE; AVOBENZONE; OCTOCRYLENE 6; 2; 10 g/100g; g/100g; g/100g N 20181231 63354-150_53069955-6543-5ee3-e054-00144ff8d46c 63354-150 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 10; 6 g/100g; g/100g; g/100g N 20181231 63354-151_5cf221ab-97bb-5272-e053-2a91aa0a4113 63354-151 HUMAN OTC DRUG Banana Boat AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE SPRAY TOPICAL 20150408 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 10; 5; 5; 3 g/100g; g/100g; g/100g; g/100g N 20181231 63354-160_53061fde-27be-285a-e054-00144ff88e88 63354-160 HUMAN OTC DRUG BANANA BOAT avobenzone, octocrylene, oxybenzone STICK TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; OXYBENZONE; AVOBENZONE 10; 6; 2 g/100g; g/100g; g/100g N 20181231 63354-161_53061fde-27b0-285a-e054-00144ff88e88 63354-161 HUMAN OTC DRUG BANANA BOAT avobenzone, octocrylene, oxybenzone STICK TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; OXYBENZONE; AVOBENZONE 10; 6; 2 g/100g; g/100g; g/100g N 20181231 63354-162_53060d47-c350-4066-e054-00144ff8d46c 63354-162 HUMAN OTC DRUG BANANA BOAT avobenzone, octocrylene, oxybenzone STICK TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; OXYBENZONE; AVOBENZONE 10; 6; 2 g/100g; g/100g; g/100g N 20181231 63354-163_5a570c96-91fa-ab9a-e053-2991aa0ab8ad 63354-163 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20110826 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 10; 6 g/100g; g/100g; g/100g N 20181231 63354-170_53064e55-f348-49c2-e054-00144ff8d46c 63354-170 HUMAN OTC DRUG Banana Boat Avobenzone Homosalate Octocrylene AEROSOL TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE 2; 7; 5 g/100g; g/100g; g/100g N 20181231 63354-190_5cf23262-9b34-66fc-e053-2a91aa0ae062 63354-190 HUMAN OTC DRUG Banana Boat AVOBENZONE HOMOSALATE OCTOCRYLENE SPRAY TOPICAL 20150407 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE 1.5; 5; 3.5 g/100g; g/100g; g/100g N 20181231 63354-192_53064e55-f310-49c2-e054-00144ff8d46c 63354-192 HUMAN OTC DRUG HAWAIIAN TROPIC ILK HYDRATION WEIGHTLESS avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 5.5; 4.5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 63354-193_5306cddb-06f0-6766-e054-00144ff8d46c 63354-193 HUMAN OTC DRUG Hawaiian Tropic Silk Hydration Weightless Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE 3; 1.5; 3; 4.5 g/100g; g/100g; g/100g; g/100g N 20181231 63354-201_53061fde-2809-285a-e054-00144ff88e88 63354-201 HUMAN OTC DRUG Banana Boat Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; HOMOSALATE 3; 5; 10; 6; 10 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 63354-219_52f20e5d-bb68-6308-e054-00144ff88e88 63354-219 HUMAN OTC DRUG BANANA BOAT avobenzone, octocrylene, oxybenzone LOTION TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 EdgewellPersonal Care Brands LLC OCTOCRYLENE; OXYBENZONE; AVOBENZONE 8; 3.5; 2.5 g/100g; g/100g; g/100g N 20181231 63354-220_5a570c96-9240-ab9a-e053-2991aa0ab8ad 63354-220 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE OIL TOPICAL 20121119 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 4; 3 g/100g; g/100g; g/100g; g/100g N 20181231 63354-228_61590c3b-cb0a-5cbe-e053-2a91aa0a0cb3 63354-228 HUMAN OTC DRUG HAWAIIAN TROPIC avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 5.5; 4.5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 63354-229_6155868a-f28d-6a7f-e053-2991aa0ae45d 63354-229 HUMAN OTC DRUG Hawaiian Tropic Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE 3; 1.5; 3; 4.5 g/100g; g/100g; g/100g; g/100g N 20181231 63354-260_5d04e45a-9d01-4fb3-e053-2991aa0ace3e 63354-260 HUMAN OTC DRUG Hawaiian Tropic avobenzone, homosalate, octisalate, octocrylene, oxybenzone OIL TOPICAL 20121203 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 5; 5; 2.4; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 63354-288_52f1587d-575f-157f-e054-00144ff8d46c 63354-288 HUMAN OTC DRUG Hawaiian Tropic Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; HOMOSALATE; OCTISALATE 2; 4; 5.5; 4.5 g/100g; g/100g; g/100g; g/100g N 20181231 63354-289_52e243c8-7b8f-35ff-e054-00144ff88e88 63354-289 HUMAN OTC DRUG Hawaiian Tropic Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE; OXYBENZONE 3; 5; 3; 10; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 63354-300_4d9e648a-7bf2-3306-e054-00144ff8d46c 63354-300 HUMAN OTC DRUG HAWAIIAN TROPIC avobenzone, octocrylene, oxybenzone STICK TOPICAL 20120111 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care LLC OXYBENZONE; OCTOCRYLENE; AVOBENZONE 6; 10; 1 g/100g; g/100g; g/100g N 20181231 63354-314_5f1150f5-299f-cde4-e053-2991aa0a55de 63354-314 HUMAN OTC DRUG Banana Boat AVOBENZONE HOMOSALATE OCTOCRYLENE LOTION TOPICAL 20170605 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands, LLC HOMOSALATE; AVOBENZONE; OCTOCRYLENE 10; 3; 6 g/100g; g/100g; g/100g N 20181231 63354-323_60b39d5c-5bb1-3dbc-e053-2a91aa0a550b 63354-323 HUMAN OTC DRUG BANANA BOAT HOMOSALATE OCTOCRYLENE SPRAY TOPICAL 20150224 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC HOMOSALATE; OCTOCRYLENE 3; 1 g/100g; g/100g N 20181231 63354-326_52e1f6ff-f4bb-693a-e054-00144ff8d46c 63354-326 HUMAN OTC DRUG Banana Boat Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 6.5 g/100g; g/100g N 20181231 63354-328_52e1f6ff-f4c9-693a-e054-00144ff8d46c 63354-328 HUMAN OTC DRUG Banana Boat Titanium Dioxide, Zinc oxide LOTION TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 6.5 g/100g; g/100g N 20181231 63354-332_5e7093db-755c-a48f-e053-2a91aa0afae7 63354-332 HUMAN OTC DRUG BANANA BOAT AVOBENZONE HOMOSALATE OCTOCRYLENE SPRAY TOPICAL 20150224 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE 1; 3; 2 g/100g; g/100g; g/100g N 20181231 63354-340_5e70d4bb-7456-f14c-e053-2a91aa0a3134 63354-340 HUMAN OTC DRUG BANANA BOAT AVOBENZONE HOMOSALATE OCTOCRYLENE SPRAY TOPICAL 20150224 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; AVOBENZONE; HOMOSALATE 3.5; 1.5; 5 g/100g; g/100g; g/100g N 20181231 63354-353_5cf258d5-bc1f-a8a1-e053-2991aa0aeb42 63354-353 HUMAN OTC DRUG BANANA BOAT AVOBENZONE HOMOSALATE OCTOCRYLENE SPRAY TOPICAL 20150223 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE 2; 7; 5 g/100g; g/100g; g/100g N 20181231 63354-387_616d35f6-63d3-3d26-e053-2991aa0a5b44 63354-387 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE 9; 2.7; 9; 4.5 g/100g; g/100g; g/100g; g/100g N 20181231 63354-388_616d35a1-a138-1974-e053-2a91aa0a20b6 63354-388 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE 9; 2.7; 9; 4.5 g/100g; g/100g; g/100g; g/100g N 20181231 63354-389_616bd006-f6a0-0a1a-e053-2991aa0a6616 63354-389 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE 9; 2.7; 9; 4.5 g/100g; g/100g; g/100g; g/100g N 20181231 63354-392_61e28dca-f136-7b16-e053-2991aa0a534c 63354-392 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands, LLC HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 6; 4.5; 3; 4.5 g/100g; g/100g; g/100g; g/100g N 20191231 63354-394_61e291c7-2261-13b2-e053-2991aa0a0348 63354-394 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands, LLC HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 9; 4; 3; 5 g/100g; g/100g; g/100g; g/100g N 20191231 63354-410_53060d47-c360-4066-e054-00144ff8d46c 63354-410 HUMAN OTC DRUG Banana Boat Avobenzone, Homosalate, Octisalate, Octocrylene OIL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 4.5; 3.2; 2.4; 3 g/100g; g/100g; g/100g; g/100g N 20181231 63354-431_530681a3-40dc-59f4-e054-00144ff8d46c 63354-431 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20150311 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 3; 2 g/100g; g/100g; g/100g N 20181231 63354-432_53063cb4-a2cf-4a2a-e054-00144ff8d46c 63354-432 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20150316 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OXYBENZONE; OCTOCRYLENE; AVOBENZONE 3; 5; 2 g/100g; g/100g; g/100g N 20181231 63354-458_52f1d47a-9c42-5b61-e054-00144ff88e88 63354-458 HUMAN OTC DRUG Hawaiian Tropic Avobenzone Homosalate Octisalate Octocrylene LOTION TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE 2.7; 4.5; 5; 8 g/100g; g/100g; g/100g; g/100g N 20181231 63354-459_52f1d47a-9c50-5b61-e054-00144ff88e88 63354-459 HUMAN OTC DRUG Hawaiian Tropic Avobenzone Homosalate Octisalate Octocrylene LOTION TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands, LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE 2; 4.5; 4; 5.5 g/100g; g/100g; g/100g; g/100g N 20181231 63354-590_5d05cd48-0bdd-d4a3-e053-2a91aa0a7839 63354-590 HUMAN OTC DRUG Hawaiian Tropic Avobenzone Octocrylene Oxybenzone LOTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 2; 2 g/100g; g/100g; g/100g N 20181231 63354-592_5d04c875-9cc1-d08f-e053-2a91aa0a7605 63354-592 HUMAN OTC DRUG Hawaiian Tropic Avobenzone Octocrylene Oxybenzone LOTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 5; 3 g/100g; g/100g; g/100g N 20181231 63354-601_5306595a-d86d-1edb-e054-00144ff88e88 63354-601 HUMAN OTC DRUG Hawaiian Tropic Avobenzone Homosalate Octisalate Octocrylene LOTION TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE; HOMOSALATE 1.5; 4.5; 3; 3 g/100g; g/100g; g/100g; g/100g N 20181231 63354-625_52f1587d-5770-157f-e054-00144ff8d46c 63354-625 HUMAN OTC DRUG HAWAIIAN TROPIC avobenzone, octocrylene LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; AVOBENZONE 1; .5 g/100g; g/100g N 20181231 63354-654_52f1587d-5751-157f-e054-00144ff8d46c 63354-654 HUMAN OTC DRUG Hawaiian Tropic Avobenzone, Octocrylene, Oxybenzone LOTION TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OXYBENZONE; AVOBENZONE; OCTOCRYLENE 4; 3; 6 g/100g; g/100g; g/100g N 20181231 63354-711_530688da-c26f-35cc-e054-00144ff88e88 63354-711 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 2; 1; 1.5; 3 g/100g; g/100g; g/100g; g/100g N 20181231 63354-720_53069955-6513-5ee3-e054-00144ff8d46c 63354-720 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE SPRAY TOPICAL 20150331 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 5.5; 4.5; 4 g/100g; g/100g; g/100g; g/100g N 20181231 63354-724_5cf229db-a7e1-257d-e053-2991aa0a51d5 63354-724 HUMAN OTC DRUG Banana Boat AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE AEROSOL TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE 5; 6; 10; 3; 10 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 63354-731_53069955-6503-5ee3-e054-00144ff8d46c 63354-731 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE SPRAY TOPICAL 20150330 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.7; 9; 4.5; 6 g/100g; g/100g; g/100g; g/100g N 20181231 63354-755_52e23faf-ffce-1512-e054-00144ff88e88 63354-755 HUMAN OTC DRUG Banana Boat Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 6.5 g/100g; g/100g N 20181231 63354-757_5f1108cf-4df5-708b-e053-2991aa0a2e79 63354-757 HUMAN OTC DRUG Banana Boat Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE 4; 3; 9; 5 g/100g; g/100g; g/100g; g/100g N 20181231 63354-781_5b3775e2-79a2-c9fe-e053-2a91aa0abe96 63354-781 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20120104 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 10; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 63354-786_5cf258d5-bc64-a8a1-e053-2991aa0aeb42 63354-786 HUMAN OTC DRUG Banana Boat Avobenzone, Homosalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 2; 7; 1.5; 3 g/100g; g/100g; g/100g; g/100g N 20181231 63354-787_5cf258d5-bc55-a8a1-e053-2991aa0aeb42 63354-787 HUMAN OTC DRUG Banana Boat Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 10; 3; 5; 3; 4 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 63354-788_5e701916-3bfe-37cf-e053-2a91aa0a577e 63354-788 HUMAN OTC DRUG Banana Boat Avobenzone, Homosalate, Octisalate, Octocrylene AEROSOL, SPRAY TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; OCTISALATE; HOMOSALATE 3; 6; 5; 10 g/100g; g/100g; g/100g; g/100g N 20181231 63354-795_5f0c5b4a-b40e-8294-e053-2a91aa0acbce 63354-795 HUMAN OTC DRUG Banana Boat AVOBENZONE HOMOSALATE OCTOCRYLENE LOTION TOPICAL 20151015 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; HOMOSALATE 3; 4; 5 g/100g; g/100g; g/100g N 20181231 63354-796_5306c51e-c3d1-3b4f-e054-00144ff88e88 63354-796 HUMAN OTC DRUG Banana Boat AVOBENZONE HOMOSALATE OCTOCRYLENE LOTION TOPICAL 20151015 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE 3; 9; 5 g/100g; g/100g; g/100g N 20181231 63354-813_52e243c8-7b72-35ff-e054-00144ff88e88 63354-813 HUMAN OTC DRUG Banana Boat Avobenzone, Homosalate, Octocrylene LOTION TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE 2.2; 7; 4.2 g/100g; g/100g; g/100g N 20181231 63354-825_5305f1e1-3b1b-3bd1-e054-00144ff8d46c 63354-825 HUMAN OTC DRUG Hawaiian Tropic Avobenzone, Homosalate, Octisalate, Octocrylene AEROSOL TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE 4.5; 4; 2; 5.5 g/100g; g/100g; g/100g; g/100g N 20181231 63354-826_5305f1e1-3b2a-3bd1-e054-00144ff8d46c 63354-826 HUMAN OTC DRUG Hawaiian Tropic Avobenzone, Homosalate, Octisalate, Octocrylene AEROSOL TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.5; 3; 1; 3 g/100g; g/100g; g/100g; g/100g N 20181231 63354-860_53061fde-27cc-285a-e054-00144ff88e88 63354-860 HUMAN OTC DRUG Banana Boat Avobenzone, Homosalate, Octisalate, Octocrylene OIL TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 4.5; 3.2; 2.4; 3 g/100g; g/100g; g/100g; g/100g N 20181231 63354-875_5cf04ed0-70e7-758b-e053-2991aa0a4943 63354-875 HUMAN OTC DRUG Hawaiian Tropic Avobenzone Octocrylene AEROSOL TOPICAL 20120106 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE 3; 5 g/100g; g/100g N 20181231 63354-880_5f0dc2d8-c720-50f9-e053-2991aa0a0c09 63354-880 HUMAN OTC DRUG Banana Boat AVOBENZONE HOMOSALATE OCTOCRYLENE LOTION TOPICAL 20150219 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC HOMOSALATE; AVOBENZONE; OCTOCRYLENE 10; 3; 6 g/100g; g/100g; g/100g N 20181231 63354-890_5306cddb-06c5-6766-e054-00144ff8d46c 63354-890 HUMAN OTC DRUG Banana Boat AVOBENZONE HOMOSALATE OCTOCRYLENE LOTION TOPICAL 20150223 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; AVOBENZONE; HOMOSALATE 5; 1.8; 7 g/100g; g/100g; g/100g N 20181231 63354-891_5cf05db3-140b-31f9-e053-2a91aa0a3fb7 63354-891 HUMAN OTC DRUG Hawaiian Tropic Avobenzone Octocrylene Oxybenzone LOTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2; 5; 3 g/100g; g/100g; g/100g N 20181231 63354-900_5cf23262-9b22-66fc-e053-2a91aa0ae062 63354-900 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE AEROSOL, SPRAY TOPICAL 20120710 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 7.4; 3 g/100g; g/100g; g/100g N 20181231 63354-910_53061fde-27ea-285a-e054-00144ff88e88 63354-910 HUMAN OTC DRUG BANANA BOAT avobenzone, octocrylene, oxybenzone AEROSOL, SPRAY TOPICAL 20120710 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OXYBENZONE; OCTOCRYLENE 3; 5; 10 g/100g; g/100g; g/100g N 20181231 63354-911_53067008-6584-55d8-e054-00144ff8d46c 63354-911 HUMAN OTC DRUG Banana Boat AVOBENZONE OCTOCRYLENE OXYBENZONE LOTION TOPICAL 20150219 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 2.5; 8; 3.5 g/100g; g/100g; g/100g N 20181231 63354-917_61d06b61-5296-2627-e053-2991aa0a70ed 63354-917 HUMAN OTC DRUG Banana Boat HOMOSALATE, OCTINOXATE, OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC ZINC OXIDE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 7.3; 9; 1; 6 g/100g; g/100g; g/100g; g/100g N 20191231 63354-918_61d1b051-4357-ab51-e053-2991aa0a32a0 63354-918 HUMAN OTC DRUG Banana Boat Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE 7; 9; 3; 4.5 g/100g; g/100g; g/100g; g/100g N 20191231 63354-922_617bf6e8-2458-3fd7-e053-2991aa0aedda 63354-922 HUMAN OTC DRUG Banana Boat TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 6.5 g/100g; g/100g N 20181231 63354-923_617df17d-8def-5fa7-e053-2a91aa0addd4 63354-923 HUMAN OTC DRUG Banana Boat Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE 6; 9; 3; 4.5 g/100g; g/100g; g/100g; g/100g N 20181231 63354-924_617d6f4f-9808-12ae-e053-2991aa0ad247 63354-924 HUMAN OTC DRUG Banana Boat TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 6.5 g/100g; g/100g N 20181231 63354-925_61cca28e-8fbd-c312-e053-2a91aa0a64e0 63354-925 HUMAN OTC DRUG Banana Boat Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE 6; 9; 3; 4.5 g/100g; g/100g; g/100g; g/100g N 20191231 63354-930_5b46cdc3-f4ba-11d8-e053-2a91aa0af26d 63354-930 HUMAN OTC DRUG BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE SPRAY TOPICAL 20111229 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; OCTOCRYLENE; OXYBENZONE 1; 7.7; 3 g/100g; g/100g; g/100g N 20181231 63354-932_53063cb4-a2ed-4a2a-e054-00144ff8d46c 63354-932 HUMAN OTC DRUG BANANA BOAT avobenzone, octocrylene, oxybenzone SPRAY TOPICAL 20111229 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OXYBENZONE; AVOBENZONE; OCTOCRYLENE 3; 1; 7.7 g/100g; g/100g; g/100g N 20181231 63354-961_53061fde-27fb-285a-e054-00144ff88e88 63354-961 HUMAN OTC DRUG Banana Boat Octocrylene, Zinc Oxide LOTION TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC ZINC OXIDE; OCTOCRYLENE 5; 4 g/100g; g/100g N 20181231 63354-980_53063cb4-a2b3-4a2a-e054-00144ff8d46c 63354-980 HUMAN OTC DRUG HAWAIIAN TROPIC octocrylene, oxybenzone LOTION TOPICAL 20100928 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; OXYBENZONE 1; .5 g/100g; g/100g N 20181231 63354-981_53063cb4-a2dd-4a2a-e054-00144ff8d46c 63354-981 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE HOMOSALATE OCTOCRYLENE SPRAY TOPICAL 20150304 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; AVOBENZONE; HOMOSALATE 5; 2; 7 g/100g; g/100g; g/100g N 20181231 63354-992_5efe4310-1cc3-1e42-e053-2a91aa0ace1b 63354-992 HUMAN OTC DRUG HAWAIIAN TROPIC DRY SPF 30 avobenzone,octocrylene,oxybenzone SPRAY TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC OCTOCRYLENE; AVOBENZONE; OXYBENZONE 7.7; 2; 3 g/100g; g/100g; g/100g N 20181231 63354-993_53067008-6575-55d8-e054-00144ff8d46c 63354-993 HUMAN OTC DRUG Hawaiian Tropic AVOBENZONE HOMOSALATE OCTOCRYLENE SPRAY TOPICAL 20150227 OTC MONOGRAPH NOT FINAL part352 Edgewell Personal Care Brands LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE 1.5; 5; 3.5 g/100g; g/100g; g/100g N 20181231 63354-996_62e78589-f2a7-4d15-e053-2991aa0a36ac 63354-996 HUMAN OTC DRUG Wet Ones benzethonium chloride SWAB TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part333A Edgewell Personal Care Brands LLC BENZETHONIUM CHLORIDE .3 1/1001 N 20191231 63354-997_62e54505-8145-4451-e053-2a91aa0a2fc5 63354-997 HUMAN OTC DRUG Wet Ones Benzethonium Chloride SWAB TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part333A Edgewell Personal Care Brands LLC BENZETHONIUM CHLORIDE .3 1/1001 N 20191231 63354-998_53064e55-f31e-49c2-e054-00144ff8d46c 63354-998 HUMAN OTC DRUG Wet Ones Benzethonium Chloride SWAB TOPICAL 20071001 OTC MONOGRAPH NOT FINAL part333A Edgewell Personal Care Brands LLC BENZETHONIUM CHLORIDE .3 1/1001 N 20181231 63354-999_53063cb4-a2fc-4a2a-e054-00144ff8d46c 63354-999 HUMAN OTC DRUG Wet Ones benzethonium chloride SWAB TOPICAL 20071001 OTC MONOGRAPH NOT FINAL part333A Edgewell Personal Care Brands LLC BENZETHONIUM CHLORIDE .3 1/1001 N 20181231 63372-0596_429f845a-0ab2-735f-e054-00144ff8d46c 63372-0596 HUMAN OTC DRUG Greenco Greenco PASTE, DENTIFRICE DENTAL; ORAL 19971015 OTC MONOGRAPH FINAL part355 Greenco Industries, Inc. SODIUM FLUORIDE 2.4 mg/g N 20181231 63374-507_13268742-9953-4faf-841e-b5e4c24f182e 63374-507 HUMAN OTC DRUG Steuarts Pain Formula Arnica Montana Flower and Comfrey Leaf CREAM TOPICAL 20160901 UNAPPROVED HOMEOPATHIC Steuart Laboratories INC ARNICA MONTANA FLOWER; COMFREY LEAF 1; 1 [hp_X]/g; [hp_X]/g E 20171231 63377-024_7c3da1dd-8ad0-422b-882b-2591ea6c00ff 63377-024 HUMAN OTC DRUG GERM FREE 24 PLUS Hand Sanitizer and Protectant BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part333E Coating Systems Laboratories, Inc. BENZALKONIUM CHLORIDE 10 mg/100mL E 20171231 63385-001_2a43aa11-0a3b-4370-9d7d-0cc8c033a317 63385-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19910101 UNAPPROVED MEDICAL GAS Ferguson Industrial Gases dba Ferguson Enterprises OXYGEN 99 L/100L E 20171231 63395-201_2ea8571d-9d4b-4933-93c5-c23b97a90269 63395-201 HUMAN PRESCRIPTION DRUG Evoxac cevimeline hydrochloride CAPSULE ORAL 20000112 NDA NDA020989 Daiichi Sankyo, Inc. CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20191231 63398-1072_670ca6ff-5237-4e6f-b33a-31957a29bf25 63398-1072 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19820101 UNAPPROVED MEDICAL GAS A.V. Pulmonary Care OXYGEN 99 L/100L N 20181231 63401-681_871d31a5-0d59-48c1-8d5d-ba31f4182a9f 63401-681 HUMAN OTC DRUG SANITACK SANITIZING WIPES PLUS BENZALKONIUM CHLORIDE CLOTH TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part333E CAN Creations BENZALKONIUM CHLORIDE .01417 g/1 E 20171231 63402-190_2bea59a8-97a7-47bc-8455-b8eb625b25d7 63402-190 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Sunovion Pharmaceuticals Inc. ESZOPICLONE 1 mg/1 CIV N 20181231 63402-191_2bea59a8-97a7-47bc-8455-b8eb625b25d7 63402-191 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Sunovion Pharmaceuticals Inc. ESZOPICLONE 2 mg/1 CIV N 20181231 63402-193_2bea59a8-97a7-47bc-8455-b8eb625b25d7 63402-193 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Sunovion Pharmaceuticals Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 63402-201_3db57776-183a-4c12-8ad9-bc96d0a1b716 63402-201 HUMAN PRESCRIPTION DRUG LONHALA MAGNAIR glycopyrrolate SOLUTION RESPIRATORY (INHALATION) 20180129 NDA NDA208437 Sunovion Pharmaceuticals Inc. GLYCOPYRROLATE 25 ug/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 63402-202_aa75db97-7b33-40c9-92e2-b2dc80bfbba3 63402-202 HUMAN PRESCRIPTION DRUG Aptiom ESLICARBAZEPINE ACETATE TABLET ORAL 20140407 NDA NDA022416 Sunovion Pharmaceuticals Inc. ESLICARBAZEPINE ACETATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63402-204_aa75db97-7b33-40c9-92e2-b2dc80bfbba3 63402-204 HUMAN PRESCRIPTION DRUG Aptiom ESLICARBAZEPINE ACETATE TABLET ORAL 20140407 NDA NDA022416 Sunovion Pharmaceuticals Inc. ESLICARBAZEPINE ACETATE 400 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63402-206_aa75db97-7b33-40c9-92e2-b2dc80bfbba3 63402-206 HUMAN PRESCRIPTION DRUG Aptiom ESLICARBAZEPINE ACETATE TABLET ORAL 20140407 NDA NDA022416 Sunovion Pharmaceuticals Inc. ESLICARBAZEPINE ACETATE 600 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63402-208_aa75db97-7b33-40c9-92e2-b2dc80bfbba3 63402-208 HUMAN PRESCRIPTION DRUG Aptiom ESLICARBAZEPINE ACETATE TABLET ORAL 20140407 NDA NDA022416 Sunovion Pharmaceuticals Inc. ESLICARBAZEPINE ACETATE 800 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63402-248_aa75db97-7b33-40c9-92e2-b2dc80bfbba3 63402-248 HUMAN PRESCRIPTION DRUG Aptiom ESLICARBAZEPINE ACETATE KIT ORAL 20140407 NDA NDA022416 Sunovion Pharmaceuticals Inc. N 20181231 63402-301_3db57776-183a-4c12-8ad9-bc96d0a1b716 63402-301 HUMAN PRESCRIPTION DRUG LONHALA MAGNAIR glycopyrrolate SOLUTION RESPIRATORY (INHALATION) 20180129 NDA NDA208437 Sunovion Pharmaceuticals Inc. GLYCOPYRROLATE 25 ug/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 63402-302_1ac4f198-aee2-4db4-917e-8896a31a36ec 63402-302 HUMAN PRESCRIPTION DRUG Latuda lurasidone hydrochloride TABLET, FILM COATED ORAL 20111207 NDA NDA200603 Sunovion Pharmaceuticals Inc. LURASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 63402-304_1ac4f198-aee2-4db4-917e-8896a31a36ec 63402-304 HUMAN PRESCRIPTION DRUG Latuda lurasidone hydrochloride TABLET, FILM COATED ORAL 20101028 NDA NDA200603 Sunovion Pharmaceuticals Inc. LURASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 63402-306_1ac4f198-aee2-4db4-917e-8896a31a36ec 63402-306 HUMAN PRESCRIPTION DRUG Latuda lurasidone hydrochloride TABLET, FILM COATED ORAL 20130712 NDA NDA200603 Sunovion Pharmaceuticals Inc. LURASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 63402-308_1ac4f198-aee2-4db4-917e-8896a31a36ec 63402-308 HUMAN PRESCRIPTION DRUG Latuda lurasidone hydrochloride TABLET, FILM COATED ORAL 20101028 NDA NDA200603 Sunovion Pharmaceuticals Inc. LURASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 63402-312_1ac4f198-aee2-4db4-917e-8896a31a36ec 63402-312 HUMAN PRESCRIPTION DRUG Latuda lurasidone hydrochloride TABLET, FILM COATED ORAL 20120426 NDA NDA200603 Sunovion Pharmaceuticals Inc. LURASIDONE HYDROCHLORIDE 120 mg/1 Atypical Antipsychotic [EPC] N 20181231 63402-510_2cec95ae-bb6d-419e-acde-e1bbbb44b5b4 63402-510 HUMAN PRESCRIPTION DRUG Xopenex HFA levalbuterol tartrate AEROSOL, METERED ORAL 20051201 NDA NDA021730 Sunovion Pharmaceuticals Inc. LEVALBUTEROL TARTRATE 45 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 63402-675_eb5c4825-7786-487e-ae9e-52e40408f2f1 63402-675 HUMAN PRESCRIPTION DRUG ARCAPTA NEOHALER INDACATEROL MALEATE CAPSULE ORAL; RESPIRATORY (INHALATION) 20110701 NDA NDA022383 Sunovion Pharmaceuticals Inc. INDACATEROL MALEATE 75 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 63402-681_55537528-a2b0-47c6-a596-2aee9ba7acf1 63402-681 HUMAN PRESCRIPTION DRUG UTIBRON NEOHALER INDACATEROL MALEATE and GLYCOPYRROLATE CAPSULE RESPIRATORY (INHALATION) 20151029 NDA NDA207930 Sunovion Pharmaceuticals Inc. INDACATEROL MALEATE; GLYCOPYRROLATE 27.5; 15.6 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 63402-701_5f5cd2a6-030f-48d6-b7da-b60ff8bf7412 63402-701 HUMAN PRESCRIPTION DRUG Omnaris ciclesonide SPRAY NASAL 20080301 NDA NDA022004 Sunovion Pharmaceuticals Inc. CICLESONIDE 50 ug/1 N 20181231 63402-711_b16f6db0-5e2c-424b-b75c-713d34651abb 63402-711 HUMAN PRESCRIPTION DRUG Alvesco ciclesonide AEROSOL, METERED RESPIRATORY (INHALATION) 20081001 NDA NDA021658 Sunovion Pharmaceuticals Inc. CICLESONIDE 80 ug/1 N 20181231 63402-712_b16f6db0-5e2c-424b-b75c-713d34651abb 63402-712 HUMAN PRESCRIPTION DRUG Alvesco ciclesonide AEROSOL, METERED RESPIRATORY (INHALATION) 20081001 NDA NDA021658 Sunovion Pharmaceuticals Inc. CICLESONIDE 160 ug/1 N 20181231 63402-737_1f501927-7ef1-48d8-ade5-7fc7006e0db1 63402-737 HUMAN PRESCRIPTION DRUG Zetonna ciclesonide AEROSOL, METERED NASAL 20120730 NDA NDA202129 Sunovion Pharmaceuticals Inc. CICLESONIDE 37 ug/1 N 20181231 63402-815_7c54f051-4e1c-4b5d-98ef-df5a1e35b83f 63402-815 HUMAN PRESCRIPTION DRUG SEEBRI NEOHALER GLYCOPYRROLATE CAPSULE RESPIRATORY (INHALATION) 20171029 NDA NDA207923 Sunovion Pharmacueticals Inc. GLYCOPYRROLATE 15.6 ug/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 63402-911_ae0844c6-4134-4c18-9c8e-8bf718ef6157 63402-911 HUMAN PRESCRIPTION DRUG Brovana arformoterol tartrate SOLUTION RESPIRATORY (INHALATION) 20070401 NDA NDA021912 Sunovion Pharmaceuticals Inc. ARFORMOTEROL TARTRATE 15 ug/2mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 63404-0201_e7a26348-1e2a-45bb-98ec-acd036d48cf8 63404-0201 HUMAN OTC DRUG SprinJene Natural Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20170201 OTC MONOGRAPH FINAL part355 Health and Natural Beauty USA Corp SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g N 20181231 63404-0910_98fdc29c-4831-46bd-bba0-f80097e5c4df 63404-0910 HUMAN OTC DRUG SprinJene Fresh Boost Sodium Fluoride GEL, DENTIFRICE DENTAL 20141010 OTC MONOGRAPH FINAL part355 Health and Natural Beauty USA Corp SODIUM FLUORIDE 1.5 mg/g N 20181231 63404-1108_93edd50c-b02b-4d94-87ed-33436a6f8b94 63404-1108 HUMAN OTC DRUG SprinJene Health Boost Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20160701 OTC MONOGRAPH FINAL part355 Health and Natural Beauty USA Corp SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g N 20181231 63404-1116_41ec84a0-b2d2-49c4-9e76-167f20ab9481 63404-1116 HUMAN OTC DRUG SprinJene White Boost Sodium Fluoride PASTE, DENTIFRICE DENTAL 20141010 OTC MONOGRAPH FINAL part355 Health and Natural Beauty USA Corp SODIUM FLUORIDE 1.5 mg/g N 20181231 63404-1203_dbfeaa4d-279a-49c5-9cce-b69b509d47e6 63404-1203 HUMAN OTC DRUG SprinJene Natural Watermelon Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20170201 OTC MONOGRAPH FINAL part355 Health and Natural Beauty USA Corp SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g N 20181231 63404-1942_c00995ff-76f6-4ec9-ad97-a9c4e911e284 63404-1942 HUMAN OTC DRUG SprinJene Natural Sensitivity Relief Sodium Monofluorophosphate and Potassium Nitrate PASTE, DENTIFRICE DENTAL 20170701 OTC MONOGRAPH NOT FINAL part356 Health and Natural Beauty USA Corp SODIUM MONOFLUOROPHOSPHATE; POTASSIUM NITRATE 1.5; 50 mg/g; mg/g N 20181231 63404-2014_dbfeaa4d-279a-49c5-9cce-b69b509d47e6 63404-2014 HUMAN OTC DRUG SprinJene Natural Apple-Mint Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20170201 OTC MONOGRAPH FINAL part355 Health and Natural Beauty USA Corp SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g N 20181231 63418-0001_f5d3ed7a-123e-47ad-98d0-201452c00324 63418-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990601 UNAPPROVED MEDICAL GAS Rogers Pharmacy OXYGEN 99 L/100L E 20171231 63433-122_46dc0604-585b-463c-bd9f-7c959fb7e94a 63433-122 HUMAN OTC DRUG DHC Body Sunscreen Milk Titanium Dioxide LOTION TOPICAL 20090401 OTC MONOGRAPH NOT FINAL part352 DHC USA Incorporated TITANIUM DIOXIDE 210 mg/2mL E 20171231 63433-222_24c114b4-fed5-4992-a88c-4379e605a7ff 63433-222 HUMAN OTC DRUG DHC Camu Camu White Day Milk Octinoxate and Oxybenzone LOTION TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 DHC USA Incorporated OCTINOXATE; OXYBENZONE 35; 5 mg/.5mL; mg/.5mL E 20171231 63433-389_53d8c847-eba0-4604-b339-144a29b07758 63433-389 HUMAN OTC DRUG DHC Acne Spot Therapy Sulfur CREAM TOPICAL 20180101 OTC MONOGRAPH FINAL part333D DHC USA Incorporated SULFUR 6 mg/.2g N 20181231 63433-451_e5c473eb-f2b7-4063-8cd7-ec2341b96265 63433-451 HUMAN OTC DRUG DHC White Sunscreen Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20050501 20181226 OTC MONOGRAPH NOT FINAL part352 DHC USA Incorporated TITANIUM DIOXIDE; ZINC OXIDE 50; 100 mg/g; mg/g E 20171231 63433-894_78a70422-ae97-4377-b59d-bee2672929b1 63433-894 HUMAN OTC DRUG DHC Salicylic Acne Wash Salicylic Acid LOTION TOPICAL 20110801 20180615 OTC MONOGRAPH FINAL part333D DHC USA Incorporated SALICYLIC ACID 30 mg/1.5mL N 20181231 63433-895_883dcce9-730b-49b4-80a8-befcb0b3987c 63433-895 HUMAN OTC DRUG DHC Salicylic Acne Toner Salicylic Acid LIQUID TOPICAL 20110801 20180724 OTC MONOGRAPH FINAL part333D DHC USA Incorporated SALICYLIC ACID 50.5 mg/2.5mL N 20181231 63433-896_ccf5bf2d-5761-41e1-a559-ad47f4c0aed7 63433-896 HUMAN OTC DRUG DHC Salicylic Face Milk Salicylic Acid LOTION TOPICAL 20110801 20180710 OTC MONOGRAPH FINAL part358H DHC USA Incorporated SALICYLIC ACID 20 mg/mL N 20181231 63433-897_fa9899bd-8a9c-4ff2-a8ef-92db5b15b9aa 63433-897 HUMAN OTC DRUG DHC Acne Spot Therapy Sulfur CREAM TOPICAL 20110801 20181112 OTC MONOGRAPH FINAL part333D DHC USA Incorporated SULFUR 6 mg/.2g E 20171231 63459-101_ced9fa26-5ff2-4afd-93e1-209e1665ca50 63459-101 HUMAN PRESCRIPTION DRUG Provigil Modafinil TABLET ORAL 19990215 NDA NDA020717 Cephalon, Incorporated MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 63459-177_ac6c18d2-3fea-42f8-8ce7-20019b6c622e 63459-177 HUMAN PRESCRIPTION DRUG SYNRIBO Omacetaxine Mepesuccinate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20121119 NDA NDA203585 Cephalon, Inc. OMACETAXINE MEPESUCCINATE 3.5 mg/mL N 20181231 63459-201_ced9fa26-5ff2-4afd-93e1-209e1665ca50 63459-201 HUMAN PRESCRIPTION DRUG Provigil Modafinil TABLET ORAL 19990215 NDA NDA020717 Cephalon, Incorporated MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 63459-205_033add8c-ea48-4469-a533-ed567f2440c7 63459-205 HUMAN PRESCRIPTION DRUG Nuvigil Armodafinil TABLET ORAL 20090526 NDA NDA021875 Cephalon, Inc. ARMODAFINIL 50 mg/1 CIV N 20181231 63459-215_033add8c-ea48-4469-a533-ed567f2440c7 63459-215 HUMAN PRESCRIPTION DRUG Nuvigil Armodafinil TABLET ORAL 20090526 NDA NDA021875 Cephalon, Inc. ARMODAFINIL 150 mg/1 CIV N 20181231 63459-220_033add8c-ea48-4469-a533-ed567f2440c7 63459-220 HUMAN PRESCRIPTION DRUG Nuvigil Armodafinil TABLET ORAL 20140220 NDA NDA021875 Cephalon, Inc. ARMODAFINIL 200 mg/1 CIV N 20181231 63459-225_033add8c-ea48-4469-a533-ed567f2440c7 63459-225 HUMAN PRESCRIPTION DRUG Nuvigil Armodafinil TABLET ORAL 20090526 NDA NDA021875 Cephalon, Inc. ARMODAFINIL 250 mg/1 CIV N 20181231 63459-348_bd4944b3-f99d-48df-9e3f-02d3d4c68896 63459-348 HUMAN PRESCRIPTION DRUG BENDEKA bendamustine hydrochloride INJECTION, SOLUTION INTRAVENOUS 20151208 NDA NDA208194 Teva Pharmaceuticals USA, Inc. BENDAMUSTINE HYDROCHLORIDE 25 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 63459-390_10377dbb-834e-452b-8ffe-d68307c06f67 63459-390 HUMAN PRESCRIPTION DRUG TREANDA Bendamustine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100105 NDA NDA022249 Cephalon, Inc. BENDAMUSTINE HYDROCHLORIDE 25 mg/5mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 63459-391_10377dbb-834e-452b-8ffe-d68307c06f67 63459-391 HUMAN PRESCRIPTION DRUG TREANDA Bendamustine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080331 NDA NDA022249 Cephalon, Inc. BENDAMUSTINE HYDROCHLORIDE 100 mg/20mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20191231 63459-402_cf489961-c7d1-45a2-bfa2-f4461e088852 63459-402 HUMAN PRESCRIPTION DRUG GABITRIL Tiagabine Hydrochloride TABLET, FILM COATED ORAL 20010401 NDA NDA020646 Cephalon, Inc. TIAGABINE HYDROCHLORIDE 2 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63459-404_cf489961-c7d1-45a2-bfa2-f4461e088852 63459-404 HUMAN PRESCRIPTION DRUG GABITRIL Tiagabine Hydrochloride TABLET, FILM COATED ORAL 20010401 NDA NDA020646 Cephalon, Inc. TIAGABINE HYDROCHLORIDE 4 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63459-412_cf489961-c7d1-45a2-bfa2-f4461e088852 63459-412 HUMAN PRESCRIPTION DRUG GABITRIL Tiagabine Hydrochloride TABLET, FILM COATED ORAL 20010401 NDA NDA020646 Cephalon, Inc. TIAGABINE HYDROCHLORIDE 12 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63459-416_cf489961-c7d1-45a2-bfa2-f4461e088852 63459-416 HUMAN PRESCRIPTION DRUG GABITRIL Tiagabine Hydrochloride TABLET, FILM COATED ORAL 20010401 NDA NDA020646 Cephalon, Inc. TIAGABINE HYDROCHLORIDE 16 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63459-502_5bfb14b3-60c0-45d7-a49b-96e9276a6065 63459-502 HUMAN PRESCRIPTION DRUG ACTIQ Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 19990120 NDA NDA020747 Cephalon, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 63459-504_5bfb14b3-60c0-45d7-a49b-96e9276a6065 63459-504 HUMAN PRESCRIPTION DRUG ACTIQ Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 19990120 NDA NDA020747 Cephalon, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 63459-506_5bfb14b3-60c0-45d7-a49b-96e9276a6065 63459-506 HUMAN PRESCRIPTION DRUG ACTIQ Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 19990120 NDA NDA020747 Cephalon, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 63459-508_5bfb14b3-60c0-45d7-a49b-96e9276a6065 63459-508 HUMAN PRESCRIPTION DRUG ACTIQ Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 19990120 NDA NDA020747 Cephalon, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 63459-512_5bfb14b3-60c0-45d7-a49b-96e9276a6065 63459-512 HUMAN PRESCRIPTION DRUG ACTIQ Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 19990120 NDA NDA020747 Cephalon, Inc. FENTANYL CITRATE 1200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 63459-516_5bfb14b3-60c0-45d7-a49b-96e9276a6065 63459-516 HUMAN PRESCRIPTION DRUG ACTIQ Fentanyl Citrate LOZENGE ORAL; TRANSMUCOSAL 19990120 NDA NDA020747 Cephalon, Inc. FENTANYL CITRATE 1600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 63459-541_1b6e40c4-3ae4-4ca4-a3aa-9a674e64ed8d 63459-541 HUMAN PRESCRIPTION DRUG FENTORA Fentanyl TABLET BUCCAL; SUBLINGUAL 20061002 NDA NDA021947 Cephalon, Inc. FENTANYL CITRATE 100 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63459-542_1b6e40c4-3ae4-4ca4-a3aa-9a674e64ed8d 63459-542 HUMAN PRESCRIPTION DRUG FENTORA Fentanyl TABLET BUCCAL; SUBLINGUAL 20061002 NDA NDA021947 Cephalon, Inc. FENTANYL CITRATE 200 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63459-544_1b6e40c4-3ae4-4ca4-a3aa-9a674e64ed8d 63459-544 HUMAN PRESCRIPTION DRUG FENTORA Fentanyl TABLET BUCCAL; SUBLINGUAL 20061002 NDA NDA021947 Cephalon, Inc. FENTANYL CITRATE 400 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63459-546_1b6e40c4-3ae4-4ca4-a3aa-9a674e64ed8d 63459-546 HUMAN PRESCRIPTION DRUG FENTORA Fentanyl TABLET BUCCAL; SUBLINGUAL 20061002 NDA NDA021947 Cephalon, Inc. FENTANYL CITRATE 600 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63459-548_1b6e40c4-3ae4-4ca4-a3aa-9a674e64ed8d 63459-548 HUMAN PRESCRIPTION DRUG FENTORA Fentanyl TABLET BUCCAL; SUBLINGUAL 20061002 NDA NDA021947 Cephalon, Inc. FENTANYL CITRATE 800 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63459-600_98582d4c-0f81-4ab5-9192-151f5e7dfd66 63459-600 HUMAN PRESCRIPTION DRUG Trisenox Arsenic Trioxide INJECTION, SOLUTION INTRAVENOUS 20001015 NDA NDA021248 Cephalon, Inc. ARSENIC TRIOXIDE 1 mg/mL N 20191231 63459-601_0c28acfb-ca54-485c-8179-e567d366b42f 63459-601 HUMAN PRESCRIPTION DRUG Trisenox Arsenic Trioxide INJECTION, SOLUTION INTRAVENOUS 20171222 NDA NDA021248 Cephalon, Inc. ARSENIC TRIOXIDE 2 mg/mL N 20191231 63459-700_f8e6abe0-f078-4b79-b708-4aa49d87d8ab 63459-700 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071002 NDA NDA021777 Cephalon, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 15 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63459-701_f8e6abe0-f078-4b79-b708-4aa49d87d8ab 63459-701 HUMAN PRESCRIPTION DRUG AMRIX Cyclobenzaprine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20071001 NDA NDA021777 Cephalon, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 30 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63459-910_88691ecb-49f0-442c-b66a-a144d9587e50 63459-910 HUMAN PRESCRIPTION DRUG GRANIX tbo-filgrastim INJECTION, SOLUTION SUBCUTANEOUS 20131111 BLA BLA125294 Cephalon, Inc. FILGRASTIM, LICENSE HOLDER UNSPECIFIED 300 ug/.5mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] N 20181231 63459-912_88691ecb-49f0-442c-b66a-a144d9587e50 63459-912 HUMAN PRESCRIPTION DRUG GRANIX tbo-filgrastim INJECTION, SOLUTION SUBCUTANEOUS 20131111 BLA BLA125294 Cephalon, Inc. FILGRASTIM, LICENSE HOLDER UNSPECIFIED 480 ug/.8mL Granulocyte Colony-Stimulating Factor [Chemical/Ingredient],Granulocyte-Macrophage Colony-Stimulating Factor [Chemical/Ingredient],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC] N 20181231 63481-025_6d53ed12-d734-446a-980d-85eeaabde31f 63481-025 HUMAN PRESCRIPTION DRUG FROVA frovatriptan succinate TABLET, FILM COATED ORAL 20011108 NDA NDA021006 Endo Pharmaceuticals Inc. FROVATRIPTAN SUCCINATE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63481-160_1f7379d0-8b1f-4d21-b5f5-d331faa9fcee 63481-160 HUMAN PRESCRIPTION DRUG Megace ES megesterol acetate SUSPENSION ORAL 20050702 NDA NDA021778 Endo Pharmaceuticals, Inc. MEGESTROL ACETATE 125 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 63481-161_6d8fd03f-1f00-44c7-9d72-394e12fefc79 63481-161 HUMAN PRESCRIPTION DRUG Belbuca buprenorphine hydrochloride FILM BUCCAL 20150601 20181031 NDA NDA207932 Endo Pharmaceuticals, Inc. BUPRENORPHINE HYDROCHLORIDE 75 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 63481-183_2dd76747-a4d1-4184-8b61-8ce7e9f58920 63481-183 HUMAN PRESCRIPTION DRUG FORTESTA testosterone GEL, METERED TOPICAL 20101229 NDA NDA021463 Endo Pharmaceuticals, Inc. TESTOSTERONE 10 mg/.5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 63481-207_6d8fd03f-1f00-44c7-9d72-394e12fefc79 63481-207 HUMAN PRESCRIPTION DRUG Belbuca buprenorphine hydrochloride FILM BUCCAL 20150601 20181031 NDA NDA207932 Endo Pharmaceuticals, Inc. BUPRENORPHINE HYDROCHLORIDE 150 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 63481-229_b17ad95a-7ed2-4ff6-9a63-248753c76352 63481-229 HUMAN PRESCRIPTION DRUG Sumavel DosePro sumatriptan INJECTION SUBCUTANEOUS 20150608 NDA NDA022239 Endo Pharmaceuticals SUMATRIPTAN SUCCINATE 4 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63481-239_f35f5567-366d-478f-bd2d-addcabebc0f6 63481-239 HUMAN PRESCRIPTION DRUG Natesto testosterone GEL NASAL 20150312 20180531 NDA NDA205488 Endo Pharmaceuticals TESTOSTERONE 5.5 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 63481-348_6d8fd03f-1f00-44c7-9d72-394e12fefc79 63481-348 HUMAN PRESCRIPTION DRUG Belbuca buprenorphine hydrochloride FILM BUCCAL 20150601 20181031 NDA NDA207932 Endo Pharmaceuticals, Inc. BUPRENORPHINE HYDROCHLORIDE 300 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 63481-367_b17ad95a-7ed2-4ff6-9a63-248753c76352 63481-367 HUMAN PRESCRIPTION DRUG Sumavel DosePro sumatriptan INJECTION SUBCUTANEOUS 20150608 NDA NDA022239 Endo Pharmaceuticals SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63481-421_a973a5f7-d2d8-42a2-a08b-4125f2acd0b9 63481-421 HUMAN PRESCRIPTION DRUG Coly-Mycin S colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate SUSPENSION AURICULAR (OTIC) 20160418 NDA NDA050356 Endo Pharmaceuticals, Inc. COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE 3; 3.3; .5; 10 mg/mL; mg/mL; mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63481-519_6d8fd03f-1f00-44c7-9d72-394e12fefc79 63481-519 HUMAN PRESCRIPTION DRUG Belbuca buprenorphine hydrochloride FILM BUCCAL 20150601 20181031 NDA NDA207932 Endo Pharmaceuticals, Inc. BUPRENORPHINE HYDROCHLORIDE 450 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 63481-612_a1325ee8-019e-4531-b3ee-e023cb03c72c 63481-612 HUMAN PRESCRIPTION DRUG OPANA Oxymorphone Hydrochloride TABLET ORAL 20060626 NDA NDA021611 Endo Pharmaceuticals, Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-613_a1325ee8-019e-4531-b3ee-e023cb03c72c 63481-613 HUMAN PRESCRIPTION DRUG OPANA Oxymorphone Hydrochloride TABLET ORAL 20060626 NDA NDA021611 Endo Pharmaceuticals, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-623_8323d1ea-5537-4fc3-9615-a6cf8034a005 63481-623 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 19990630 ANDA ANDA040330 Endo Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-627_8323d1ea-5537-4fc3-9615-a6cf8034a005 63481-627 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 19990630 ANDA ANDA040330 Endo Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-628_8323d1ea-5537-4fc3-9615-a6cf8034a005 63481-628 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 20011130 ANDA ANDA040434 Endo Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-629_8323d1ea-5537-4fc3-9615-a6cf8034a005 63481-629 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 20011130 ANDA ANDA040434 Endo Pharmaceuticals, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-684_92b83d19-89a0-4328-af80-95dfbda6373b 63481-684 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20071017 NDA NDA022122 Endo Pharmaceuticals Inc. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63481-685_6d8fd03f-1f00-44c7-9d72-394e12fefc79 63481-685 HUMAN PRESCRIPTION DRUG Belbuca buprenorphine hydrochloride FILM BUCCAL 20150601 20181031 NDA NDA207932 Endo Pharmaceuticals, Inc. BUPRENORPHINE HYDROCHLORIDE 600 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 63481-687_817f16f9-1a4f-44e5-8c34-fa5f0185da5e 63481-687 HUMAN PRESCRIPTION DRUG LIDODERM lidocaine PATCH CUTANEOUS 19990320 NDA NDA020612 Endo Pharmaceuticals, Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 63481-812_ee1e2e27-7455-429d-99d1-e5962ac1eb2c 63481-812 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 20200201 NDA NDA201655 Endo Pharmaceuticals, Inc. OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-813_ee1e2e27-7455-429d-99d1-e5962ac1eb2c 63481-813 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 20190801 NDA NDA201655 Endo Pharmaceuticals, Inc. OXYMORPHONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-814_ee1e2e27-7455-429d-99d1-e5962ac1eb2c 63481-814 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 20200101 NDA NDA201655 Endo Pharmaceuticals, Inc. OXYMORPHONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-815_ee1e2e27-7455-429d-99d1-e5962ac1eb2c 63481-815 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 20200101 NDA NDA201655 Endo Pharmaceuticals, Inc. OXYMORPHONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-816_ee1e2e27-7455-429d-99d1-e5962ac1eb2c 63481-816 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 20190801 NDA NDA201655 Endo Pharmaceuticals, Inc. OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-817_ee1e2e27-7455-429d-99d1-e5962ac1eb2c 63481-817 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 20191101 NDA NDA201655 Endo Pharmaceuticals, Inc. OXYMORPHONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-818_ee1e2e27-7455-429d-99d1-e5962ac1eb2c 63481-818 HUMAN PRESCRIPTION DRUG Opana ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE ORAL 20120320 20190701 NDA NDA201655 Endo Pharmaceuticals, Inc. OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63481-820_6d8fd03f-1f00-44c7-9d72-394e12fefc79 63481-820 HUMAN PRESCRIPTION DRUG Belbuca buprenorphine hydrochloride FILM BUCCAL 20150601 20181031 NDA NDA207932 Endo Pharmaceuticals, Inc. BUPRENORPHINE HYDROCHLORIDE 750 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 63481-952_6d8fd03f-1f00-44c7-9d72-394e12fefc79 63481-952 HUMAN PRESCRIPTION DRUG Belbuca buprenorphine hydrochloride FILM BUCCAL 20150601 20181031 NDA NDA207932 Endo Pharmaceuticals, Inc. BUPRENORPHINE HYDROCHLORIDE 900 ug/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 63505-008_1f5557df-4367-408e-9bd7-7ab702f9fc26 63505-008 HUMAN OTC DRUG SOLAIRE PEAU PARFAITE SUNSCREEN SPF 30 Octinoxate, Avobenzone LOTION TOPICAL 20170415 OTC MONOGRAPH NOT FINAL part352 Yves Rocher North America Inc. OCTINOXATE; AVOBENZONE 2; .75 g/100mL; g/100mL N 20181231 63505-156_33748420-ee6d-4962-988d-d31d50d4b2d7 63505-156 HUMAN OTC DRUG Protectyl soleil moisturizing sunscreen lotion high protection spf 30 Titanium Dioxide, Octinoxate and Octocrylene LOTION TOPICAL 20070501 OTC MONOGRAPH FINAL part352 Yves Rocher North America Inc OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 7; 8.4 mL/100mL; mL/100mL; mL/100mL E 20171231 63505-157_b61bbe7d-07c4-4fcb-a6e7-2a8dd1c95f31 63505-157 HUMAN OTC DRUG FRAICHEUR VERVEINE ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20080701 OTC MONOGRAPH FINAL part350 YVES ROCHER NORTH AMERICA INC ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL E 20171231 63505-158_a95425f3-08d0-4ea4-9ec9-ab0cdb6316ca 63505-158 HUMAN OTC DRUG FRAICHEUR CEDRE BLEU ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LIQUID TOPICAL 20081001 OTC MONOGRAPH FINAL part350 YVES ROCHER NORTH AMERICA INC ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL E 20171231 63505-159_68494988-f0af-49cf-a39f-27ce07fe5247 63505-159 HUMAN OTC DRUG FRAICHEUR THE VERT ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20081001 OTC MONOGRAPH FINAL part350 YVES ROCHER NORTH AMERICA INC ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL E 20171231 63505-160_8a68e3e4-baed-4a0f-bb51-20a104c01108 63505-160 HUMAN OTC DRUG FRAICHEUR BAMBOU ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20081001 OTC MONOGRAPH FINAL part350 YVES ROCHER NORTH AMERICA INC ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL E 20171231 63505-161_3deaba9b-886a-400b-aa6b-6e35a4092731 63505-161 HUMAN OTC DRUG FRAICHEUR CHEVREFEUILLE ANTIPERSPIRANT AND DEODORANT ROLL-ON ALUMINUM SESQUICHLOROHYDRATE LOTION TOPICAL 20090201 OTC MONOGRAPH FINAL part350 YVES ROCHER NORTH AMERICA INC ALUMINUM SESQUICHLOROHYDRATE 15 mL/100mL E 20171231 63505-163_c1301bb1-b78b-4e01-8062-3022a5bc28a2 63505-163 HUMAN OTC DRUG ANTISEPTIC HAND GEL ALCOHOL GEL TOPICAL 20091211 OTC MONOGRAPH NOT FINAL part333E YVES ROCHER NORTH AMERICA INC ALCOHOL 62 mL/100mL E 20171231 63509-002_b349a64f-70d7-4163-b618-9474fcd3408c 63509-002 HUMAN OTC DRUG Skin Activator Lip Refiner SPF 15 Octinoxate, Octisalate and Avobenzone CREAM TOPICAL 20111021 OTC MONOGRAPH NOT FINAL part352 Cosmint Spa. OCTINOXATE; OCTISALATE; AVOBENZONE .0661; .0472; .0142 g/mL; g/mL; g/mL E 20171231 63517-003_60acb695-4f35-57d6-e053-2a91aa0a19a2 63517-003 HUMAN OTC DRUG Barrier Protectant Cream Barrier Cream OINTMENT TOPICAL 20150115 OTC MONOGRAPH FINAL part346 Cardinal Health MENTHOL; ZINC OXIDE 1; 200 mg/g; mg/g N 20191231 63517-009_36dfa94c-e670-498f-9a36-37547a73eef7 63517-009 HUMAN OTC DRUG Antifungal Cream 2% Miconazole Nitrate Cream CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part333C Cardinal Health MICONAZOLE NITRATE 2 g/1000g N 20181231 63517-016_85d81f07-f825-4419-81a2-d918b1740a3e 63517-016 HUMAN OTC DRUG Cardinal Health Fluoride Anticavity Fluoride Anticavity Toothpaste PASTE, DENTIFRICE ORAL 20130909 OTC MONOGRAPH FINAL part355 Cardinal Health SODIUM FLUORIDE 2.43 mg/g N 20181231 63517-021_5b4c1d8c-c629-4f9e-8df5-455498fcd9ff 63517-021 HUMAN OTC DRUG Barrier Skin Protectant 42% Petrolatum Skin Protectant CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part347 Cardinal Health PETROLATUM 43 g/1000g N 20181231 63517-061_33ae23db-5c47-0c41-e054-00144ff8d46c 63517-061 HUMAN OTC DRUG Cardinal Health CHLORHEXIDINE GLUCONATE 4% LIQUID TOPICAL 20150724 NDA NDA019125 Cardinal Health CHLORHEXIDINE GLUCONATE 2 g/100mL N 20181231 63517-112_39c1177f-fb68-4579-e054-00144ff8d46c 63517-112 HUMAN OTC DRUG CardinalHealth alcohol prep pads LARGE ISOPROPYL ALCOHOL SWAB TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL 70 g/100g N 20181231 63517-113_35b6ec88-1321-6f89-e054-00144ff8d46c 63517-113 HUMAN OTC DRUG Cardinal Health Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE 2% SOLUTION TOPICAL 20150501 NDA NDA019422 Cardinal Health CHLORHEXIDINE GLUCONATE 2 g/100mL N 20181231 63517-121_2435dfbf-1690-222a-e054-00144ff88e88 63517-121 HUMAN OTC DRUG Personal Cleansing Cloths with Dimethicone DIMETHICONE SWAB TOPICAL 20151104 OTC MONOGRAPH FINAL part347 Cardinal Health, Inc. DIMETHICONE 3.32 g/100g E 20171231 63517-122_2436376f-7542-1f5d-e054-00144ff8d46c 63517-122 HUMAN OTC DRUG Personal Cleansing Cloths with Dimethicone DIMETHICONE SWAB TOPICAL 20151105 OTC MONOGRAPH FINAL part347 Cardinal Health, Inc. DIMETHICONE 33.2 mg/g E 20171231 63517-131_c65fc540-3711-4934-af7c-5a1a063d3a24 63517-131 HUMAN OTC DRUG incontinence care wipe DIMETHICONE SWAB TOPICAL 20150821 OTC MONOGRAPH FINAL part347 Cardinal Health DIMETHICONE 32 mg/g E 20171231 63517-132_a5a36d19-fa39-475b-a46e-c3928e6b5b81 63517-132 HUMAN OTC DRUG Povidone Iodine Prep Povidone Iodine SOLUTION TOPICAL 20150826 OTC MONOGRAPH FINAL part333C Cardinal Health POVIDONE-IODINE 1 g/100mL N 20181231 63517-160_9d9e981b-afa7-4372-a7da-4d133f291fcd 63517-160 HUMAN OTC DRUG Lemon Glycerin Glycerin SWAB ORAL 20130801 OTC MONOGRAPH NOT FINAL part356 Cardinal Health GLYCERIN 7.5 g/100g N 20191231 63517-200_36e28d60-9883-1935-e054-00144ff88e88 63517-200 HUMAN OTC DRUG CardinalHealth antibacterial bathing wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131003 OTC MONOGRAPH NOT FINAL part333A Cardinal Health BENZALKONIUM CHLORIDE .12 g/100g E 20171231 63517-211_689883ba-f838-4e42-a536-e3eb323668cd 63517-211 HUMAN OTC DRUG PETROLEUM PETROLATUM JELLY TOPICAL 20150826 OTC MONOGRAPH FINAL part347 Cardinal Health PETROLATUM 1 g/g N 20181231 63517-216_6ce199a7-d211-4b91-86e0-64a9f510a635 63517-216 HUMAN OTC DRUG Cardinal Health First Aid Antibiotic NEOMYCIN SULFATE,POLYMYXIN B SULFATE,BACITRACIN ZINC OINTMENT TOPICAL 20150827 OTC MONOGRAPH FINAL part333B Cardinal Health BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 U/g; mg/g; U/g N 20181231 63517-220_9865bafb-efef-4ba1-a830-7798f78cc844 63517-220 HUMAN OTC DRUG Cardinal Health First Aid Antibiotic BACITRACIN ZINC OINTMENT TOPICAL 20150827 OTC MONOGRAPH FINAL part333B Cardinal Health BACITRACIN ZINC 500 U/g N 20181231 63517-242_35e1487b-60f8-2068-e054-00144ff88e88 63517-242 HUMAN OTC DRUG Alcohol sterile ISOPROPYL ALCOHOL SWAB TOPICAL 20150429 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL .7 mL/mL N 20181231 63517-244_35e108c6-1793-33b9-e054-00144ff8d46c 63517-244 HUMAN OTC DRUG Alcohol sterile ISOPROPYL ALCOHOL SWAB TOPICAL 20150430 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL .7 mL/mL N 20181231 63517-251_4558b643-1953-46cc-8f42-3647b70097de 63517-251 HUMAN OTC DRUG Povidone-Iodine Prep Sterile POVIDONE-IODINE SWAB TOPICAL 20150429 OTC MONOGRAPH NOT FINAL part333E Cardinal Health POVIDONE-IODINE 100 mg/g N 20181231 63517-252_e4c11485-ef4b-4e84-9870-850dd376f44b 63517-252 HUMAN OTC DRUG Povidone-Iodine Scrub Sterile POVIDONE-IODINE SWAB TOPICAL 20150429 OTC MONOGRAPH NOT FINAL part333E Cardinal Health POVIDONE-IODINE 75 mg/g N 20181231 63517-254_366b1632-fd4c-7193-e054-00144ff8d46c 63517-254 HUMAN OTC DRUG Povidone-Iodine Prep Sterile POVIDONE-IODINE SWAB TOPICAL 20150429 OTC MONOGRAPH NOT FINAL part333E Cardinal Health POVIDONE-IODINE 100 mg/g N 20181231 63517-255_affb08f1-0f40-4a44-b88f-f5c7f2b5fd96 63517-255 HUMAN OTC DRUG Povidone-Iodine Scrub Sterile POVIDONE-IODINE SWAB TOPICAL 20150429 OTC MONOGRAPH NOT FINAL part333E Cardinal Health POVIDONE-IODINE 75 mg/g N 20181231 63517-350_24d6a6e0-e8b7-27f7-e054-00144ff8d46c 63517-350 HUMAN OTC DRUG Povidone-Iodine Prep Solution POVIDONE-IODINE SOLUTION TOPICAL 20150813 OTC MONOGRAPH NOT FINAL part333E Cardinal Health POVIDONE-IODINE 10 mg/mL N 20181231 63517-351_24d6ac8e-72c1-08e7-e054-00144ff88e88 63517-351 HUMAN OTC DRUG Povidone-Iodine Scrub Solution POVIDONE-IODINE SOLUTION TOPICAL 20150813 OTC MONOGRAPH NOT FINAL part333E Cardinal Health POVIDONE-IODINE 7.5 mg/mL N 20181231 63517-400_6184451a-73a7-4af3-e053-2a91aa0a4051 63517-400 HUMAN OTC DRUG Povidone-Iodine Prep Pad POVIDONE-IODINE SOLUTION TOPICAL 20160805 OTC MONOGRAPH NOT FINAL part333A Cardinal Health POVIDONE-IODINE 10 g/100g N 20181231 63517-418_35e16a75-aba5-473e-a5ce-eb197d3b0103 63517-418 HUMAN OTC DRUG Cardinal Health Antimicrobial Soap with Triclosan TRICLOSAN LIQUID TOPICAL 20110314 OTC MONOGRAPH NOT FINAL part333E Cardinal Health TRICLOSAN .003 mL/mL E 20171231 63517-450_ac51f1cf-7947-41ca-b827-44562649c475 63517-450 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part333A Cardinal Health HYDROGEN PEROXIDE 30 mg/mL N 20181231 63517-452_27a4ce64-c1a9-46a7-b60f-446300d574a8 63517-452 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL 500 mg/mL N 20181231 63517-500_fc0109ae-7461-47e4-b4da-fe825b231786 63517-500 HUMAN OTC DRUG Alcohol Prep Pads isopropyl alcohol SWAB TOPICAL 20160202 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 63517-501_6184451a-7399-4af3-e053-2a91aa0a4051 63517-501 HUMAN OTC DRUG Antiseptic BZK Towelette BENZALKONIUM CHLORIDE CLOTH TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part333A Cardinal Health BENZALKONIUM CHLORIDE 1.3 mg/g N 20181231 63517-506_48159c5a-924f-4692-a29b-b7a487fa7eb7 63517-506 HUMAN OTC DRUG Cardinal Health Hand Sanitizer with Aloe ALCOHOL GEL TOPICAL 20110302 OTC MONOGRAPH NOT FINAL part333E Cardinal Health ALCOHOL .62 mL/mL E 20171231 63517-523_b17fd616-85b2-4a66-8063-0da25bc5e3ee 63517-523 HUMAN OTC DRUG Cardinal Health Sanitizer ALCOHOL AEROSOL, FOAM TOPICAL 20110224 OTC MONOGRAPH NOT FINAL part333E Cardinal Health ALCOHOL .625 mg/mg E 20171231 63517-600_c461ad36-c260-4a93-a16d-28046f3b8e87 63517-600 HUMAN OTC DRUG Alcohol Prep Pads isopropyl alcohol SWAB TOPICAL 20160208 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 63517-657_366b1632-fd6e-7193-e054-00144ff8d46c 63517-657 HUMAN OTC DRUG Povidone-Iodine Scrub Sterile POVIDONE-IODINE SPONGE TOPICAL 20150430 OTC MONOGRAPH NOT FINAL part333E Cardinal Health POVIDONE-IODINE 75 mg/g N 20181231 63517-658_366b1632-fd5d-7193-e054-00144ff8d46c 63517-658 HUMAN OTC DRUG Povidone-Iodine Prep Sterile POVIDONE-IODINE SPONGE TOPICAL 20150430 OTC MONOGRAPH NOT FINAL part333E Cardinal Health POVIDONE-IODINE 100 mg/g N 20181231 63517-751_366ad35f-9a28-6f51-e054-00144ff8d46c 63517-751 HUMAN OTC DRUG Povidone-Iodine Prep Winged Sterile Small POVIDONE-IODINE SPONGE TOPICAL 20150430 OTC MONOGRAPH NOT FINAL part333E Cardinal Health POVIDONE-IODINE 100 mg/g N 20181231 63517-759_4c0597ea-0d42-4b5a-af13-a7de17dd889f 63517-759 HUMAN OTC DRUG Povidone-Iodine Prep Winged Sterile Large POVIDONE-IODINE SPONGE TOPICAL 20150430 OTC MONOGRAPH NOT FINAL part333E Cardinal Health POVIDONE-IODINE 100 mg/g N 20181231 63517-803_339346ff-c4fa-435e-b643-a8581f811080 63517-803 HUMAN OTC DRUG Roll On Anti-Perspirant (Alcohol Free) ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20130904 OTC MONOGRAPH FINAL part350 Cardinal Health ALUMINUM CHLOROHYDRATE .1 mg/mL N 20181231 63533-221_1a16303b-d136-44f4-a724-2332d36d50ee 63533-221 HUMAN OTC DRUG Han-I-Size ALCOHOL GEL TOPICAL 20051201 OTC MONOGRAPH NOT FINAL part333E Momar Incorporated ALCOHOL .7 mL/mL N 20181231 63533-575_596d5e41-ce6a-446e-a66a-fb47de72de46 63533-575 HUMAN OTC DRUG 99 Plus Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20171220 OTC MONOGRAPH NOT FINAL part333E Momar Incorporated BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 63533-576_989f632e-73e0-4211-b68b-7d63944d9c90 63533-576 HUMAN OTC DRUG Handtastic Foamy Mango TRICLOSAN SOAP TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Momar Incorporated TRICLOSAN .003 mL/mL E 20171231 63533-585_8260614a-0d0d-4f14-bbf2-7a5da5d77feb 63533-585 HUMAN OTC DRUG Han-I-Foam ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Momar Incorporated ALCOHOL .7 mL/mL N 20181231 63533-773_211aaff1-5087-479e-a52c-47438579b9b5 63533-773 HUMAN OTC DRUG Redeem ALCOHOL AEROSOL, FOAM TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 Momar Inc. ALCOHOL 620 mg/g E 20171231 63533-774_facd7c9f-c537-4245-84a2-e580ec4b6336 63533-774 HUMAN OTC DRUG Redeem ALCOHOL AEROSOL, FOAM TOPICAL 20160718 OTC MONOGRAPH NOT FINAL part333E Momar Inc. ALCOHOL 620 mg/g N 20181231 63533-855_6b6a6943-c0fe-4ead-9200-7d320ef3e86d 63533-855 HUMAN OTC DRUG Han-I-Foam ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333E Momar Incorporated ALCOHOL .62 mL/mL E 20171231 63533-876_23f6eee0-27be-4a0c-8cbd-528b82cd54ae 63533-876 HUMAN OTC DRUG Handtastic Foamy Mango Antiseptic Hand and Body Wash CHLOROXYLENOL SOAP TOPICAL 20170120 OTC MONOGRAPH NOT FINAL part333E Momar Incorporated CHLOROXYLENOL 3 mg/mL N 20181231 63539-011_95885e5b-1bce-4de0-95fd-42facae7ecc4 63539-011 HUMAN PRESCRIPTION DRUG Cleocin clindamycin phosphate SUPPOSITORY VAGINAL 19990813 NDA NDA050767 U.S. Pharmaceuticals CLINDAMYCIN PHOSPHATE 100 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63539-012_2dafc9ff-d8b7-4ddd-9496-ecffa83dbf92 63539-012 HUMAN PRESCRIPTION DRUG XELJANZ tofacitinib TABLET, FILM COATED ORAL 20121108 NDA NDA203214 U.S. Pharmaceuticals TOFACITINIB CITRATE 5 mg/1 Janus Kinase Inhibitor [EPC],Janus Kinase Inhibitors [MoA] N 20181231 63539-013_97ad1752-d9b5-460f-b49c-c7551e70f07e 63539-013 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 U.S. Pharmaceuticals PREGABALIN 50 mg/1 CV N 20181231 63539-014_97ad1752-d9b5-460f-b49c-c7551e70f07e 63539-014 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 U.S. Pharmaceuticals PREGABALIN 75 mg/1 CV N 20181231 63539-021_5a22d10c-03a3-4e84-8829-0d87fc901232 63539-021 HUMAN PRESCRIPTION DRUG Estring estradiol RING VAGINAL 19960426 NDA NDA020472 U.S. Pharmaceuticals ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 63539-026_52b7daa9-f0b6-493f-91c3-c204842c43e0 63539-026 HUMAN PRESCRIPTION DRUG INLYTA axitinib TABLET, FILM COATED ORAL 20120127 NDA NDA202324 U.S. Pharmaceuticals AXITINIB 1 mg/1 Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA] N 20181231 63539-039_3247c4cb-1d8d-474f-8049-03de64ff3044 63539-039 HUMAN PRESCRIPTION DRUG Nicotrol (Professional Sample) nicotine INHALANT RESPIRATORY (INHALATION) 19970502 NDA NDA020714 US Pharmaceuticals NICOTINE 4 mg/1 Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] N 20181231 63539-044_52b7daa9-f0b6-493f-91c3-c204842c43e0 63539-044 HUMAN PRESCRIPTION DRUG INLYTA axitinib TABLET, FILM COATED ORAL 20120127 NDA NDA202324 U.S. Pharmaceuticals AXITINIB 5 mg/1 Kinase Inhibitor [EPC],Receptor Tyrosine Kinase Inhibitors [MoA] N 20181231 63539-112_efdd202d-1033-4fb9-bd7f-f35d9b885676 63539-112 HUMAN PRESCRIPTION DRUG Duavee conjugated estrogens/bazedoxifene TABLET, FILM COATED ORAL 20131115 NDA NDA022247 U.S. Pharmaceuticals ESTROGENS, CONJUGATED; BAZEDOXIFENE ACETATE .45; 20 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 63539-117_b28e4b69-b7ea-4569-bec5-be90ae7b516a 63539-117 HUMAN PRESCRIPTION DRUG BOSULIF Bosutinib monohydrate TABLET, FILM COATED ORAL 20120904 NDA NDA203341 U.S. Pharmaceuticals BOSUTINIB MONOHYDRATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63539-121_0dcd3231-552e-4243-bbc9-b8ed733d3ff4 63539-121 HUMAN PRESCRIPTION DRUG Caverject Impulse Alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20140504 NDA NDA021212 U.S. Pharmaceuticals ALPROSTADIL 10 ug/.5mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 63539-122_4317e8a5-e0c7-472d-93be-89f20a6c5fe3 63539-122 HUMAN PRESCRIPTION DRUG Duavee conjugated estrogens/bazedoxifene TABLET, FILM COATED ORAL 20131115 NDA NDA022247 U.S. Pharmaceuticals ESTROGENS, CONJUGATED; BAZEDOXIFENE ACETATE .45; 20 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 63539-183_47f19c39-9fd2-4471-9d91-08da92d4fb68 63539-183 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081031 NDA NDA022030 U.S. Pharmaceuticals FESOTERODINE FUMARATE 8 mg/1 N 20181231 63539-189_f184bcf9-0b24-4a10-8844-7fea0bc67d9a 63539-189 HUMAN PRESCRIPTION DRUG Ibrance PALBOCICLIB CAPSULE ORAL 20150203 NDA NDA207103 U.S. Pharmaceuticals PALBOCICLIB 125 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] N 20181231 63539-221_0dcd3231-552e-4243-bbc9-b8ed733d3ff4 63539-221 HUMAN PRESCRIPTION DRUG Caverject Impulse Alprostadil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRACAVERNOUS 20140504 NDA NDA021212 U.S. Pharmaceuticals ALPROSTADIL 20 ug/.5mL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [Chemical/Ingredient],Venous Vasodilation [PE] N 20181231 63539-234_f9fb5d39-ca2b-4dd4-8df8-df08693d92fe 63539-234 HUMAN PRESCRIPTION DRUG Relpax eletriptan hydrobromide TABLET, FILM COATED ORAL 20021226 NDA NDA021016 U.S. Pharmaceuticals ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63539-242_47f19c39-9fd2-4471-9d91-08da92d4fb68 63539-242 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081031 NDA NDA022030 U.S. Pharmaceuticals FESOTERODINE FUMARATE 4 mg/1 N 20181231 63539-421_c2714d79-69e5-47d2-921c-6565c578f9af 63539-421 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 U.S. Pharmaceuticals SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 63539-422_c2714d79-69e5-47d2-921c-6565c578f9af 63539-422 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 U.S. Pharmaceuticals SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 63539-473_4a2d0c20-80c8-4f52-97d9-07e5995b1ffd 63539-473 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate KIT 20060510 NDA NDA021928 U.S. Pharmaceuticals N 20181231 63539-501_2dafc9ff-d8b7-4ddd-9496-ecffa83dbf92 63539-501 HUMAN PRESCRIPTION DRUG XELJANZ XR tofacitinib TABLET, EXTENDED RELEASE ORAL 20160307 NDA NDA208246 U.S. Pharmaceuticals TOFACITINIB CITRATE 11 mg/1 Janus Kinase Inhibitor [EPC],Janus Kinase Inhibitors [MoA] N 20181231 63539-5195_7471257b-abf3-47a9-8f62-5de1fe41922a 63539-5195 HUMAN PRESCRIPTION DRUG Nicotrol (Professional Sample) nicotine INHALANT RESPIRATORY (INHALATION) 19970502 NDA NDA020714 U.S. Pharmaceuticals NICOTINE 4 mg/1 Cholinergic Nicotinic Agonist [EPC],Nicotine [Chemical/Ingredient] E 20171231 63545-142_204400b4-3049-24e1-e054-00144ff8d46c 63545-142 HUMAN OTC DRUG SINECCH ARNICA MONTANA CAPSULE ORAL 19980630 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals ARNICA MONTANA 1 [hp_M]/1 N 20181231 63545-516_20465cf6-d4b4-0f01-e054-00144ff8d46c 63545-516 HUMAN OTC DRUG SINECCHi ARNICA MONTANA CAPSULE ORAL 20070630 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals ARNICA MONTANA 1 [hp_M]/1 N 20181231 63545-517_82aa8419-5bc4-4897-8614-f08717b58c37 63545-517 HUMAN OTC DRUG TraumaCare ARNICA MONTANA CAPSULE ORAL 20070630 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals ARNICA MONTANA 1 [hp_M]/1 N 20181231 63545-637_595eeecf-1aca-4256-84ff-89a7c70e1731 63545-637 HUMAN OTC DRUG HAHNEMANN HEADACHE YTTRIUM IODIDE PELLET ORAL 20090330 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals YTTRIUM IODIDE 200 [hp_C]/1 N 20181231 63545-639_54d7e16d-7ef3-4439-99d6-994e4b112c67 63545-639 HUMAN OTC DRUG HAHNEMANN FEVER PERIDOT PELLET ORAL 20101231 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals OLIVINE 200 [hp_C]/1 N 20181231 63545-640_fd103d2d-947e-4e7e-9e2d-7b45afa46b7d 63545-640 HUMAN OTC DRUG HAHNEMANN HEADACHE KEROSENE PELLET ORAL 20101231 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals KEROSENE 200 [hp_C]/1 N 20181231 63545-644_7200b290-af60-46f5-b01b-688cb07f3f44 63545-644 HUMAN OTC DRUG HAHNEMANN COLDS YTTRIUM FLUORIDE PELLET ORAL 20101231 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals YTTRIUM FLUORIDE 200 [hp_C]/1 N 20181231 63545-645_481d63ea-9cd0-4fd6-9074-4603818ce4d8 63545-645 HUMAN OTC DRUG HAHNEMANN COLDS YTTRIUM BROMIDE PELLET ORAL 20101231 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals YTTRIUM BROMIDE 200 [hp_C]/1 N 20181231 63545-646_cb2e4476-08a3-41fc-8893-e02d25ea6b0b 63545-646 HUMAN OTC DRUG HAHNEMANN SNEEZING GLYCERIN PELLET ORAL 20110331 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals GLYCERIN 200 [hp_C]/1 N 20181231 63545-650_44462c7d-8a81-5e8d-e054-00144ff88e88 63545-650 HUMAN OTC DRUG Aluminum muriaticum Aluminum muriaticum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. ALUMINUM CHLORIDE 30 [hp_C]/[hp_C] N 20181231 63545-651_44ab7ca5-a17b-0efb-e054-00144ff8d46c 63545-651 HUMAN OTC DRUG Antimonium metallicum Antimonium metallicum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. ANTIMONY 30 [hp_C]/[hp_C] N 20181231 63545-652_44ac176b-6562-2b95-e054-00144ff8d46c 63545-652 HUMAN OTC DRUG Argentum iodatum Argentum iodatum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. SILVER IODIDE 30 [hp_C]/[hp_C] N 20181231 63545-653_44ac176b-65a3-2b95-e054-00144ff8d46c 63545-653 HUMAN OTC DRUG Aurum muriaticum natronatum Aurum muriaticum natronatum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. SODIUM TETRACHLOROAURATE 30 [hp_C]/[hp_C] N 20181231 63545-654_44ba57f6-f18c-09a4-e054-00144ff8d46c 63545-654 HUMAN OTC DRUG Bismuthum Subnitricum Bismuthum Subnitricum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. BISMUTH SUBNITRATE 30 [hp_C]/[hp_C] N 20181231 63545-655_44b9f997-87d6-1f0a-e054-00144ff88e88 63545-655 HUMAN OTC DRUG Boron Boron PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. BORON 30 [hp_C]/[hp_C] N 20181231 63545-656_44d1eff5-38f3-1a65-e054-00144ff8d46c 63545-656 HUMAN OTC DRUG CADMIUM MURIATICUM CADMIUM MURIATICUM PELLET BUCCAL; ORAL; SUBLINGUAL 20161229 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. CADMIUM CHLORIDE 30 [hp_C]/[hp_C] N 20181231 63545-657_44bb1b0d-6f06-32f5-e054-00144ff8d46c 63545-657 HUMAN OTC DRUG Cinnamomum Cinnamomum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. CINNAMON 30 [hp_C]/[hp_C] N 20181231 63545-658_44bb6a20-2143-417e-e054-00144ff8d46c 63545-658 HUMAN OTC DRUG Cobaltum Nitricum Cobaltum Nitricum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. COBALTOUS NITRATE HEXAHYDRATE 30 [hp_C]/[hp_C] N 20181231 63545-659_44bb6a20-2151-417e-e054-00144ff8d46c 63545-659 HUMAN OTC DRUG Ferrum Bromatum Ferrum Bromatum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. FERROUS BROMIDE 30 [hp_C]/[hp_C] N 20181231 63545-660_44bc7046-4a6e-7085-e054-00144ff8d46c 63545-660 HUMAN OTC DRUG Kali Phosphoricum Kali Phosphoricum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. DIBASIC POTASSIUM PHOSPHATE 30 [hp_C]/[hp_C] N 20181231 63545-661_44bcae39-2339-09ee-e054-00144ff8d46c 63545-661 HUMAN OTC DRUG Lithium Phosphoricum Lithium Phosphoricum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. LITHIUM PHOSPHATE 30 [hp_C]/[hp_C] N 20181231 63545-662_44bd01ca-5743-287d-e054-00144ff8d46c 63545-662 HUMAN OTC DRUG Magnesia Acetica Magnesia Acetica PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. MAGNESIUM ACETATE TETRAHYDRATE 30 [hp_C]/[hp_C] N 20181231 63545-663_44bd638a-3003-3d3a-e054-00144ff8d46c 63545-663 HUMAN OTC DRUG Manganum Oxydatum Nigrum Manganum Oxydatum Nigrum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. MANGANESE DIOXIDE 30 [hp_C]/[hp_C] N 20181231 63545-664_44bd9411-0c78-1729-e054-00144ff88e88 63545-664 HUMAN OTC DRUG Oenanthe Crocata Oenanthe Crocata PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. OENANTHE CROCATA ROOT 30 [hp_C]/[hp_C] N 20181231 63545-665_44bdd485-7072-28a1-e054-00144ff88e88 63545-665 HUMAN OTC DRUG Piper Methysticum Piper Methysticum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. PIPER METHYSTICUM ROOT 30 [hp_C]/[hp_C] N 20181231 63545-666_44bdd485-709d-28a1-e054-00144ff88e88 63545-666 HUMAN OTC DRUG Quercus Rubra Glandium Quercus Rubra Glandium PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. QUERCUS RUBRA WHOLE 30 [hp_C]/[hp_C] N 20181231 63545-667_44bf392a-ff38-52e2-e054-00144ff88e88 63545-667 HUMAN OTC DRUG Scandium Metallicum Scandium Metallicum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. SCANDIUM 30 [hp_C]/[hp_C] N 20181231 63545-668_44bf912b-2323-5e37-e054-00144ff88e88 63545-668 HUMAN OTC DRUG Silicium Muriaticum Silicium Muriaticum PELLET BUCCAL; ORAL; SUBLINGUAL 20161228 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. SILICON TETRACHLORIDE 30 [hp_C]/[hp_C] N 20181231 63545-669_44bf912b-239c-5e37-e054-00144ff88e88 63545-669 HUMAN OTC DRUG Strontium Metallicum Strontium Metallicum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. STRONTIUM 30 [hp_C]/[hp_C] N 20181231 63545-670_44bf1e35-abab-4f83-e054-00144ff88e88 63545-670 HUMAN OTC DRUG Strontium Muriaticum Strontium Muriaticum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. STRONTIUM CHLORIDE HEXAHYDRATE 30 [hp_C]/[hp_C] N 20181231 63545-671_44c03d86-7d8d-68f0-e054-00144ff8d46c 63545-671 HUMAN OTC DRUG Tellurium Muriaticum Tellurium Muriaticum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. TELLURIUM TETRACHLORIDE 30 [hp_C]/[hp_C] N 20181231 63545-672_44bfbbae-ddcc-625f-e054-00144ff88e88 63545-672 HUMAN OTC DRUG Veratrum Nigrum Veratrum Nigrum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. VERATRUM NIGRUM FLOWERING TOP 30 [hp_C]/[hp_C] N 20181231 63545-673_44cfb486-a602-10ee-e054-00144ff8d46c 63545-673 HUMAN OTC DRUG Rubidium Fluoratum Rubidium Fluoratum PELLET BUCCAL; ORAL; SUBLINGUAL 20161201 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. RUBIDIUM FLUORIDE 30 [hp_C]/[hp_C] N 20181231 63545-674_46638d75-9a7e-67ae-e054-00144ff8d46c 63545-674 HUMAN OTC DRUG Rhamnus Cathartica Rhamnus Cathartica PELLET BUCCAL; ORAL; SUBLINGUAL 20170118 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. RHAMNUS CATHARTICA FRUIT 30 [hp_C]/[hp_C] N 20181231 63545-675_4bb970ce-886a-20e6-e054-00144ff8d46c 63545-675 HUMAN OTC DRUG SinEcch Arnica montana CAPSULE BUCCAL; ORAL; SUBLINGUAL 20170327 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. dba Alpine Pharmaceuticals ARNICA MONTANA 1000 [hp_C]/[hp_C] N 20181231 63545-676_4ce57287-184e-4b5b-e054-00144ff8d46c 63545-676 HUMAN OTC DRUG Oleum santali Oleum santali PELLET BUCCAL; ORAL; SUBLINGUAL 20170411 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. SANDALWOOD OIL 30 [hp_C]/[hp_C] N 20181231 63545-677_4ea28c24-ab9d-174d-e054-00144ff88e88 63545-677 HUMAN OTC DRUG Dipsacus Sylvestris Dipsacus Sylvestris PELLET BUCCAL; ORAL; SUBLINGUAL 20170503 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. DIPSACUS FULLONUM WHOLE 30 [hp_C]/[hp_C] N 20181231 63545-678_4eb51bae-ae02-52e3-e054-00144ff8d46c 63545-678 HUMAN OTC DRUG Divalproex Sodium Divalproex Sodium PELLET BUCCAL; ORAL; SUBLINGUAL 20170504 UNAPPROVED HOMEOPATHIC Hahnenmann Laboratories, Inc. DIVALPROEX SODIUM 30 [hp_C]/[hp_C] N 20181231 63545-679_4eb5674e-12d2-0309-e054-00144ff88e88 63545-679 HUMAN OTC DRUG Kali Aceticum Kali Aceticum PELLET BUCCAL; ORAL; SUBLINGUAL 20170504 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. POTASSIUM ACETATE 30 [hp_C]/[hp_C] N 20181231 63545-680_4eb5674e-12d7-0309-e054-00144ff88e88 63545-680 HUMAN OTC DRUG Kali Tartaricum Kali Tartaricum PELLET BUCCAL; ORAL; SUBLINGUAL 20170504 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. POTASSIUM TARTRATE 30 [hp_C]/[hp_C] N 20181231 63545-681_4eb5df53-43ec-0542-e054-00144ff8d46c 63545-681 HUMAN OTC DRUG Kali Telluricosum Kali Telluricosum PELLET BUCCAL; ORAL; SUBLINGUAL 20170504 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. POTASSIUM TELLURITE 30 [hp_C]/[hp_C] N 20181231 63545-682_4eb687fd-6376-2f13-e054-00144ff88e88 63545-682 HUMAN OTC DRUG Manganum Fluoratum Manganum Fluoratum PELLET BUCCAL; ORAL; SUBLINGUAL 20170504 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. MANGANESE DIFLUORIDE 30 [hp_C]/[hp_C] N 20181231 63545-683_4eb9441b-27c7-1b8f-e054-00144ff88e88 63545-683 HUMAN OTC DRUG Mercurius Cyanatus Mercurius Cyanatus PELLET BUCCAL; ORAL; SUBLINGUAL 20170504 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. MERCURIC CYANIDE 30 [hp_C]/[hp_C] N 20181231 63545-684_4eb9e960-b1c4-6914-e054-00144ff8d46c 63545-684 HUMAN OTC DRUG Nitri Spiritus Dulcis Nitri Spiritus Dulcis PELLET BUCCAL; ORAL; SUBLINGUAL 20170504 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. ETHYL NITRITE 30 [hp_C]/[hp_C] N 20181231 63545-685_4eba86c2-61d0-1002-e054-00144ff8d46c 63545-685 HUMAN OTC DRUG Pix Liquida Pix Liquida PELLET BUCCAL; ORAL; SUBLINGUAL 20170504 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. PINE TAR 30 [hp_C]/[hp_C] N 20181231 63545-686_4ebaa367-2c67-431b-e054-00144ff88e88 63545-686 HUMAN OTC DRUG Plumeria Rubra Plumeria Rubra PELLET BUCCAL; ORAL; SUBLINGUAL 20170504 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. PLUMERIA RUBRA WHOLE 30 [hp_C]/[hp_C] N 20181231 63545-687_4eba86c2-61d5-1002-e054-00144ff8d46c 63545-687 HUMAN OTC DRUG Scandium Muriaticum Scandium Muriaticum PELLET BUCCAL; ORAL; SUBLINGUAL 20170504 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. SCANDIUM CHLORIDE 30 [hp_C]/[hp_C] N 20181231 63545-688_4ec9b6dd-d634-3cc1-e054-00144ff88e88 63545-688 HUMAN OTC DRUG Vanilla Planifolia Vanilla Planifolia PELLET BUCCAL; ORAL; SUBLINGUAL 20170505 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. VANILLA PLANIFOLIA WHOLE 30 [hp_C]/[hp_C] N 20181231 63545-689_4f05e2e2-17a3-4e67-e054-00144ff8d46c 63545-689 HUMAN OTC DRUG Wheat Berry Wheat Berry PELLET BUCCAL; ORAL; SUBLINGUAL 20170508 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. WHEAT 30 [hp_C]/[hp_C] N 20181231 63545-690_4f064789-1642-3b21-e054-00144ff88e88 63545-690 HUMAN OTC DRUG Zincum Iodatum Zincum Iodatum PELLET BUCCAL; ORAL; SUBLINGUAL 20170508 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. ZINC IODIDE 30 [hp_C]/[hp_C] N 20181231 63545-691_4f072bb7-d5d5-68b3-e054-00144ff88e88 63545-691 HUMAN OTC DRUG Zincum Oxydatum Zincum Oxydatum PELLET BUCCAL; ORAL; SUBLINGUAL 20170508 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. ZINC OXIDE 30 [hp_C]/[hp_C] N 20181231 63545-692_4f08cfc9-7b01-33aa-e054-00144ff88e88 63545-692 HUMAN OTC DRUG Zirconium Carbonicum Zirconium Carbonicum PELLET BUCCAL; ORAL; SUBLINGUAL 20170508 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. ZIRCONIUM CARBONATE HYDROXIDE OXIDE 30 [hp_C]/[hp_C] N 20181231 63545-693_5e808c4a-b3c6-0a05-e053-2991aa0a42a2 63545-693 HUMAN OTC DRUG Ruthenium bromatum Ruthenium bromatum PELLET BUCCAL; ORAL; SUBLINGUAL 20171121 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. RUTHENIUM TRIBROMIDE 30 [hp_C]/[hp_C] N 20181231 63545-694_5e80d6f0-aca8-5600-e053-2a91aa0a05c8 63545-694 HUMAN OTC DRUG Scandium iodatum Scandium iodatum PELLET BUCCAL; ORAL; SUBLINGUAL 20171121 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. SCANDIUM IODIDE 30 [hp_C]/[hp_C] N 20181231 63545-695_5e811783-cbf3-d0e3-e053-2991aa0ae69f 63545-695 HUMAN OTC DRUG Silicium nitricatum Silicium nitricatum PELLET BUCCAL; ORAL; SUBLINGUAL 20171121 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. SILICON NITRIDE 30 [hp_C]/[hp_C] N 20181231 63545-696_5e816186-518e-606e-e053-2a91aa0a3460 63545-696 HUMAN OTC DRUG Stannum arsenatum Stannum arsenatum PELLET BUCCAL; ORAL; SUBLINGUAL 20171121 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. TIN MONOARSENIDE 30 [hp_C]/[hp_C] N 20181231 63545-697_5e818e99-6d48-2ef9-e053-2a91aa0a9fb0 63545-697 HUMAN OTC DRUG Tantalum carbonatum Tantalum carbonatum PELLET BUCCAL; ORAL; SUBLINGUAL 20171121 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. TANTALUM CARBIDE 30 [hp_C]/[hp_C] N 20181231 63545-698_5e8142fd-aa4a-00b3-e053-2991aa0a02ed 63545-698 HUMAN OTC DRUG Titanium carbonatum Titanium carbonatum PELLET BUCCAL; ORAL; SUBLINGUAL 20171121 UNAPPROVED HOMEOPATHIC Hahnemann Laboratories, Inc. TITANIUM CARBIDE 30 [hp_C]/[hp_C] N 20181231 63548-0065_89c90659-b059-4b99-bdce-b31d3e78a48c 63548-0065 HUMAN OTC DRUG Pain Relief PM Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20120514 OTC MONOGRAPH NOT FINAL part343 Avema Pharma Solutions ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 63548-0101_c23d30a1-1b43-419f-8f99-6b244c84e8ee 63548-0101 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20170227 ANDA ANDA207867 PLD Acquisitions LLC DBA Avéma Pharma Solutions ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63548-0102_c23d30a1-1b43-419f-8f99-6b244c84e8ee 63548-0102 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20170227 ANDA ANDA207867 PLD Acquisitions LLC DBA Avéma Pharma Solutions ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63548-0107_654c446d-9b7b-4200-acbf-926a4ac0dda0 63548-0107 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20100102 OTC MONOGRAPH FINAL part341 PLD Acquisitions LLC DBA Avéma Pharma Solutions GUAIFENESIN 400 mg/1 N 20181231 63548-0109_189e0ad2-ab0a-4369-983f-2110aa6b79bd 63548-0109 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr TABLET ORAL 20100102 OTC MONOGRAPH FINAL part341 PLD Acquisitions LLC DBA Avéma Pharma Solutions GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 63548-0185_89449d89-2b22-4f60-950f-ff6aca78d9a1 63548-0185 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130801 ANDA ANDA076460 Avema Pharma Solutions IBUPROFEN 200 mg/1 N 20181231 63548-0186_e4294e26-4d6a-46b5-84f4-090d646a1f63 63548-0186 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130801 ANDA ANDA076460 Avema Pharma Solutions IBUPROFEN 200 mg/1 N 20181231 63548-0227_8b30a203-4ade-4d75-aac7-f460bdcf8855 63548-0227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20100102 OTC MONOGRAPH NOT FINAL part343 PLD Acquisitions LLC DBA Avéma Pharma Solutions ASPIRIN 81 mg/1 N 20181231 63548-0234_e70dff1c-681a-4f58-95fe-48a8cea7028c 63548-0234 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130801 ANDA ANDA076460 Avema Pharma Solutions IBUPROFEN 200 mg/1 N 20181231 63548-0235_e70640a1-a3d3-45f5-8533-e1981b31a725 63548-0235 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20130801 ANDA ANDA076460 Avema Pharma Solutions IBUPROFEN 200 mg/1 N 20181231 63548-0400_3a5e861d-e46d-42e3-a105-071e3501d74d 63548-0400 HUMAN OTC DRUG Sleep Aid Nighttime Diphenhydramine HCl TABLET ORAL 20100102 OTC MONOGRAPH FINAL part338 PLD Acquisitions LLC DBA Avéma Pharma Solutions DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63548-0484_7dca17ff-3133-4437-863c-e04f00509d82 63548-0484 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20100102 OTC MONOGRAPH NOT FINAL part334 PLD Acquisitions LLC DBA Avéma Pharma Solutions DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 63548-0485_b4393032-55db-4a40-a65e-403f37a79e28 63548-0485 HUMAN OTC DRUG Senna S DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20100102 OTC MONOGRAPH NOT FINAL part334 PLD Acquisitions LLC DBA Avéma Pharma Solutions DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 63548-0486_3b08fc96-c823-48f2-978c-85752c8e94a8 63548-0486 HUMAN OTC DRUG Senna laxative Sennosides TABLET ORAL 20100102 OTC MONOGRAPH NOT FINAL part334 PLD Acquisitions LLC DBA Avéma Pharma Solutions SENNOSIDES 8.6 mg/1 N 20181231 63548-0494_4551f6b2-1d0b-4241-b795-f44000f35dbd 63548-0494 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20100102 OTC MONOGRAPH NOT FINAL part343 PLD Acquisitions LLC DBA Avéma Pharma Solutions ACETAMINOPHEN 500 mg/1 N 20181231 63548-0690_ef254e39-0ea2-4ec5-a519-dd189de3d6c0 63548-0690 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20100102 OTC MONOGRAPH FINAL part341 PLD Acquisitions LLC DBA Avéma Pharma Solutions DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63548-2341_691c5587-3994-45e2-a669-608ba7a98bfb 63548-2341 HUMAN OTC DRUG Pain Relief PM Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20100102 UNAPPROVED DRUG OTHER Avema Pharma Solutions ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 63549-919_e6f0f0dd-940a-490f-a404-56dd561264e6 63549-919 HUMAN PRESCRIPTION DRUG ISOXSUPRINE HYDROCHLORIDE isoxsuprine hydrochloride TABLET ORAL 20110823 UNAPPROVED DRUG OTHER Vedco dba Valdar ISOXSUPRINE HYDROCHLORIDE 20 mg/1 E 20171231 63550-114_032bdb34-57da-4a6d-b88a-5358b3807c37 63550-114 HUMAN OTC DRUG LIP BALM OCTINOXATE OXYBENZONE ZINC OXIDE OINTMENT TOPICAL 20120307 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. OCTINOXATE; OXYBENZONE; ZINC OXIDE 75; 50; 40 mg/g; mg/g; mg/g N 20181231 63550-120_8f3e15c7-aae1-4add-b028-d9b9081bb798 63550-120 HUMAN OTC DRUG DAY C AVOBENZONE OCTINOXATE OXYBENZONE CREAM TOPICAL 20120312 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 20; 70; 50 mg/g; mg/g; mg/g N 20181231 63550-122_e847604f-6169-4e63-9a46-a71458b44cb2 63550-122 HUMAN OTC DRUG DAY L AVOBENZONE OCTISALATE OCTINOXATE LOTION TOPICAL 20120307 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 25; 75; 40 mg/mL; mg/mL; mg/mL N 20181231 63550-154_ac2c8d21-73dc-4bc5-9378-f9e1ca13fca3 63550-154 HUMAN OTC DRUG Anti-Blemish Salicylic Acid DISC TOPICAL 20100809 OTC MONOGRAPH FINAL part333 Kamins Dermatologics Inc. SALICYLIC ACID 20 mg/1 N 20181231 63550-158_08ec1173-8886-4703-9792-5e957d6c1608 63550-158 HUMAN OTC DRUG Tinted Moisturizer SPF 20 ZINC OXIDE TITANIUM DIOXIDE CREAM TOPICAL 20110831 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. ZINC OXIDE; TITANIUM DIOXIDE 75; 44 mg/mL; mg/mL E 20171231 63550-191_6a4261c3-68ef-4108-9898-dbed33861919 63550-191 HUMAN OTC DRUG Matte Moisturizer SPF 15 OCTINOXATE OCTISALATE AVOBENZONE CREAM TOPICAL 20101018 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. OCTINOXATE; OCTISALATE; AVOBENZONE 75; 40; 25 mg/mL; mg/mL; mg/mL N 20181231 63550-192_cdf7ecb2-4019-4046-97fa-762acfda4a5b 63550-192 HUMAN OTC DRUG Soothing Day SPF 15 AVOBENZONE OCTINOXATE OXYBENZONE CREAM TOPICAL 20101019 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE 20; 70; 50 mg/mL; mg/mL; mg/mL N 20181231 63550-193_c97bc999-1ba0-454e-9a53-735e2d0337b3 63550-193 HUMAN OTC DRUG Blemish Benzoyl peroxide GEL TOPICAL 20101019 OTC MONOGRAPH NOT FINAL part333D Kamins Dermatologics Inc. BENZOYL PEROXIDE 50 mg/mL N 20181231 63550-194_75dc31bc-4d3f-482d-abd3-d60cdddcf89d 63550-194 HUMAN OTC DRUG BLEMISH Benzoyl peroxide GEL TOPICAL 20101019 OTC MONOGRAPH NOT FINAL part333D Kamins Dermatologics Inc. BENZOYL PEROXIDE 100 mg/mL N 20181231 63550-809_30b4cbbf-d534-4fca-9e49-05738ba8e688 63550-809 HUMAN OTC DRUG Sunbar SPF 48 Ensulizole Homosalate Octinoxate Octocrylene Zinc oxide CREAM TOPICAL 20100929 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. ENSULIZOLE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 30; 100; 75; 70; 80 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 63550-810_e20e5f13-95b4-4bfc-9b95-44533d0c533f 63550-810 HUMAN OTC DRUG SUNBAR SPF 15 AVOBENZONE HOMOSALATE OCTISALATE OXYBENZONE SPRAY TOPICAL 20100930 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 30; 100; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 63550-811_df11c3bb-6819-4495-baed-c2c9d9baee86 63550-811 HUMAN OTC DRUG SUNBAR SPF 30 Avobenzone Octinoxate Oxybenzone Titanium dioxide LOTION TOPICAL 20101015 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 25; 75; 6; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 63550-850_3f806047-1d73-45c8-870a-3c7cdfcd08b8 63550-850 HUMAN OTC DRUG SUN DEFENSE SPF 15 AVOBENZONE HOMOSALATE OCTISALATE OXYBENZONE SPRAY TOPICAL 20110902 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 30; 100; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 63550-851_bb4d7be9-2550-424b-80a0-b968df95e619 63550-851 HUMAN OTC DRUG SUN DEFENSE SPF 30 Avobenzone Octinoxate Oxybenzone Titanium dioxide LOTION TOPICAL 20110902 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 25; 75; 6; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 63550-852_54f7851c-d8e2-45a0-847d-e49cd78c6661 63550-852 HUMAN OTC DRUG Sun Defense UVscreen SPF 48 Ensulizole Homosalate Octinoxate Octocrylene Zinc oxide CREAM TOPICAL 20110902 OTC MONOGRAPH FINAL part352 Kamins Dermatologics Inc. ENSULIZOLE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 30; 100; 75; 70; 80 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 63551-007_fb4de2f6-cc67-4144-9a72-5005acbd9297 63551-007 HUMAN OTC DRUG Stat-Foam ALCOHOL LIQUID TOPICAL 20080901 OTC MONOGRAPH NOT FINAL part333E Triad Group ALCOHOL .7 mL/mL E 20171231 63551-220_3f1a3be7-28d3-40aa-bbbd-771d979e3507 63551-220 HUMAN OTC DRUG Health Stat TRICLOSAN SOAP TOPICAL 20001218 OTC MONOGRAPH NOT FINAL part333 Triad Group TRICLOSAN .003 mL/mL E 20171231 63551-221_97d8bcb3-f8f5-4d45-abfe-9fd93b820b88 63551-221 HUMAN OTC DRUG Stat-Rinse ALCOHOL GEL TOPICAL 20001201 OTC MONOGRAPH NOT FINAL part333 Triad Group ALCOHOL .7 mL/mL E 20171231 63551-576_af758b7e-ec81-4827-b043-4abd805b5b74 63551-576 HUMAN OTC DRUG Health-Stat Foam TRICLOSAN SOAP TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Triad Group TRICLOSAN .003 mL/mL E 20171231 63560-001_35204a4e-2262-4206-b26b-e79556668b90 63560-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980501 UNAPPROVED MEDICAL GAS Memorial Home Services of Central Illinois, Inc OXYGEN 992 mL/L E 20171231 63565-0001_af9b295a-d949-4a12-a2e5-4ebaa4f2b098 63565-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930801 UNAPPROVED MEDICAL GAS Williams Medical Supply, Inc. OXYGEN 99 L/100L E 20171231 63577-035_8d4416f6-19a3-42fe-9f78-1d4537bd4ec1 63577-035 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20050801 UNAPPROVED MEDICAL GAS Central Medical Equipment Co. OXYGEN 99 L/100L E 20171231 63580-269_ed5b3bd0-cb5b-4caf-8c00-f528081e3a98 63580-269 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Coastal Med Tech, Inc. OXYGEN 99 L/100L E 20171231 63621-353_c593bf39-c84f-4d5a-b260-c0c58747b18f 63621-353 HUMAN OTC DRUG SunDrops 67 Chloroxylenol LIQUID CUTANEOUS 20100707 UNAPPROVED DRUG OTHER Sunburst Chemicals, Inc. CHLOROXYLENOL .75 g/100mL N 20181231 63621-354_d7f22bb7-71d7-43ec-b81d-99af044efa33 63621-354 HUMAN OTC DRUG SunDrops 77 Benzalkonium Chloride SOAP TOPICAL 20080505 OTC MONOGRAPH NOT FINAL part333E Sunburst Chemicals, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 63621-355_bc0bc37c-da49-420d-888e-06965c73a2fe 63621-355 HUMAN OTC DRUG SunDrops 73 Alcohol SOAP TOPICAL 20091014 OTC MONOGRAPH NOT FINAL part333E Sunburst Chemicals, Inc. ALCOHOL 650 mL/L N 20181231 63621-356_a62e8b45-8c22-4ced-9427-f12fc4fa4383 63621-356 HUMAN OTC DRUG SunDrops 75 Alcohol GEL TOPICAL 20091014 OTC MONOGRAPH NOT FINAL part333E Sunburst Chemicals, Inc. ALCOHOL .6 mL/mL N 20181231 63621-357_56c8833c-8a77-4e86-9ac8-88123a55d161 63621-357 HUMAN OTC DRUG SunDrops 35 Benzalkonium Chloride SOAP TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part333E Sunburst Chemicals, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 63621-400_41545171-227e-4cb5-9a6b-ab83cd4a86a7 63621-400 HUMAN OTC DRUG Prestige Chloroxylenol SOAP TOPICAL 20140502 OTC MONOGRAPH NOT FINAL part333E Sunburst Chemicals, Inc. CHLOROXYLENOL 10 mg/mL N 20181231 63629-1233_9b3589d8-4928-4107-9bce-0f803cc1682b 63629-1233 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 Bryant Ranch Prepack LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63629-1241_1d295d65-ebf9-440e-aa59-747418d09ce0 63629-1241 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET, FILM COATED ORAL 20100225 ANDA ANDA075504 Bryant Ranch Prepack QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63629-1242_71f771ac-b917-494d-8737-682ba06a4d40 63629-1242 HUMAN PRESCRIPTION DRUG Accupril quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA NDA019885 Bryant Ranch Prepack QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63629-1248_8c358cd9-f387-47d9-946f-c0551f5a6501 63629-1248 HUMAN PRESCRIPTION DRUG Amoxicillin/Clavulanate Potassium Amoxicillin/Clavulanate Potassium TABLET ORAL 20090612 ANDA ANDA065093 bryant ranch prepack AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 63629-1249_d9c14a7e-285b-4226-88ca-4199afbc1265 63629-1249 HUMAN PRESCRIPTION DRUG Allegra-D FEXOFENADINE AND PSEUDOEPHEDRINE TABLET, EXTENDED RELEASE ORAL 20090304 ANDA ANDA020786 bryant ranch prepack FEXOFENADINE; PSEUDOEPHEDRINE 60; 60 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 63629-1250_ec2aef91-2bef-479f-a5c6-b42d4dd8e38a 63629-1250 HUMAN PRESCRIPTION DRUG Flurbiprofen Flurbiprofen TABLET, FILM COATED ORAL 19950602 ANDA ANDA074431 Bryant Ranch Prepack FLURBIPROFEN 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-1253_194e09a4-fcdb-4024-822a-b15066a0875d 63629-1253 HUMAN PRESCRIPTION DRUG RAMIPRIL RAMIPRIL CAPSULE ORAL 20090505 ANDA ANDA076549 Bryant Ranch Prepack RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63629-1254_e583f2ee-3dbe-4322-b88e-36f6a4e5f3d7 63629-1254 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Bryant Ranch Prepack RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-1255_b0e4346c-1b5b-48a5-91dc-3403bc9485ec 63629-1255 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Bryant Ranch Prepack GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-1260_1acdc98b-2ac1-00da-2bc6-d3ec78b5b015 63629-1260 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Bryant Ranch Prepack NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-1260_a79c6fb7-46d1-465b-8e1f-31f3a1fc98b3 63629-1260 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20090730 ANDA ANDA078432 bryant ranch prepack NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-1263_7829437b-a9ca-4ff7-869b-82bcbe774684 63629-1263 HUMAN PRESCRIPTION DRUG Arava leflunomide TABLET, FILM COATED ORAL 19980910 NDA NDA020905 Bryant Ranch Prepack LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] E 20171231 63629-1266_3b8d031d-3609-451a-be83-441877722f28 63629-1266 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 19810603 ANDA ANDA087128 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 63629-1284_c3af0b77-ee2b-4659-b8f3-2909b543f2b4 63629-1284 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060623 ANDA ANDA065154 Bryant Ranch Prepack CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63629-1286_d418c769-56b0-46bc-8f4b-acb0334e4fd9 63629-1286 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077156 Bryant Ranch Prepack BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 63629-1299_fac764bd-542e-4ca8-9fbf-3299b613e3b4 63629-1299 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 Bryant Ranch Prepack DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 63629-1305_55629d6a-5dbf-4f11-bfbf-557e5957c944 63629-1305 HUMAN PRESCRIPTION DRUG Cefaclor Cefaclor CAPSULE ORAL 20091106 ANDA ANDA064156 bryant ranch prepack CEFACLOR 250 mg/1 E 20171231 63629-1307_9823b3f9-99a4-4522-846d-ffaa5945a699 63629-1307 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961111 ANDA ANDA070848 Bryant Ranch Prepack SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 63629-1308_10c236b1-5b05-47bd-b32b-27b1457829be 63629-1308 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Bryant Ranch Prepack CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV E 20171231 63629-1309_dd570961-2da8-484b-911c-bd58e22b7bfd 63629-1309 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Bryant Ranch Prepack DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63629-1318_6465b138-fa89-4560-a8a3-dbb06333385c 63629-1318 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20150529 ANDA ANDA077032 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-1326_f262185f-b0bc-45ef-86f3-4af962f38fd8 63629-1326 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Bryant Ranch Prepack CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63629-1328_f4f9fc6a-6b84-473a-b126-07be5fd0af7f 63629-1328 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070974 Bryant Ranch Prepack CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63629-1329_c4f306db-2e82-4c41-b6a1-b6008fc272f2 63629-1329 HUMAN PRESCRIPTION DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Bryant Ranch Prepack LORATADINE 10 mg/1 E 20171231 63629-1330_49422e04-2bc1-46b6-8198-aa37a195d818 63629-1330 HUMAN PRESCRIPTION DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Bryant Ranch Prepack LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 63629-1335_e5fcec79-bca3-4f0d-b24d-0ca6d03ba248 63629-1335 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 Bryant Ranch Prepack PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 63629-1337_1b89c719-ac97-466f-b73c-c431364f6489 63629-1337 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Bryant Ranch Prepack LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-1338_b2e10e07-ab6c-4f3c-8cf7-c2d9d0adcbf3 63629-1338 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Bryant Ranch Prepack CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63629-1339_52b8cff3-a7b3-45b8-847c-8c4f94fcf354 63629-1339 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20100218 ANDA ANDA078218 Bryant Ranch Prepack CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63629-1340_4e0ad552-1e28-44f4-8092-cb2699d58eb2 63629-1340 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Bryant Ranch Prepack CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63629-1341_f2f3e45c-e187-4f0d-8214-6e981140f9ac 63629-1341 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Bryant Ranch Prepack CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63629-1342_e19b9dde-c1f5-4bdc-8ee9-86bbc08a2e7e 63629-1342 HUMAN OTC DRUG Docusate Sodium and Senna Docusate Sodium and Senna TABLET, FILM COATED ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 E 20171231 63629-1343_eac4c726-7e7e-4bc1-a93f-9dbbd3e5c157 63629-1343 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20000501 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 63629-1345_8d707616-a7f4-424d-975d-f80401364878 63629-1345 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20030512 ANDA ANDA075849 Bryant Ranch Prepack OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-1346_f7d3daa3-c21a-48a2-89f4-481e74b66a5e 63629-1346 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Bryant Ranch Prepack TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 63629-1349_1c7e8e35-8a03-4b3f-ae8e-112fab41b440 63629-1349 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 E 20171231 63629-1354_6b9d7def-4022-4541-aa45-aab7f9770499 63629-1354 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 Bryant Ranch Prepack OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 63629-1355_5bd59be7-62be-4220-8ddf-0cc8179a84c8 63629-1355 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20110308 ANDA ANDA075536 Bryant Ranch Prepack DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63629-1360_c7a5837a-5137-4eb2-982b-f72b20db6241 63629-1360 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20070122 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack DOCUSATE SODIUM 100 mg/1 N 20181231 63629-1369_f078347f-665c-4e78-bf21-28b5f5e701b4 63629-1369 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET ORAL 20091023 ANDA ANDA085966 bryant ranch prepack AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63629-1370_a799397d-141d-42fe-a889-806d20e4756c 63629-1370 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63629-1374_79c5b637-b777-4087-9207-bf29189ad56a 63629-1374 HUMAN PRESCRIPTION DRUG Erythrocin Stearate Erythromycin Stearate TABLET, FILM COATED ORAL 19640624 ANDA ANDA060359 Bryant Ranch Prepack ERYTHROMYCIN STEARATE 500 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 63629-1376_7a113b45-4b5b-40f7-aed4-4b09959f3eda 63629-1376 HUMAN PRESCRIPTION DRUG Lodine etodolac CAPSULE, GELATIN COATED ORAL 20090630 ANDA ANDA075126 bryant ranch prepack ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-1377_edf62cf7-1a1c-474d-b950-97c057106606 63629-1377 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 Bryant Ranch Prepack ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-1386_f8d8f290-0f7a-4c26-b1ca-0fc5bf814257 63629-1386 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 Bryant Ranch Prepack METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 63629-1388_f8d8f290-0f7a-4c26-b1ca-0fc5bf814257 63629-1388 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 Bryant Ranch Prepack METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 63629-1390_ea9fdf28-6b36-4d0c-95b3-05e3a2e188cd 63629-1390 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19981001 ANDA ANDA075034 Bryant Ranch Prepack GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 63629-1392_fabcb1e1-c02a-4a1a-8bc8-0bdadcb9f296 63629-1392 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20070507 ANDA ANDA076345 Bryant Ranch Prepack GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 63629-1393_b34ddafe-fae5-4dec-ae42-ccb64a2df21f 63629-1393 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Bryant Ranch Prepack GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 63629-1394_2e4f911d-daa1-4a04-abca-fc89941a0faf 63629-1394 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Bryant Ranch Prepack GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-1395_1670818d-944a-4a36-96ff-54f10f8ddf34 63629-1395 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63629-1396_1f0130b5-9bfc-4000-a4d6-cf91e4755af7 63629-1396 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20090603 ANDA ANDA079148 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 63629-1397_7104201d-b184-4d46-9a2e-841f1b4c0d32 63629-1397 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20020129 ANDA ANDA075967 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63629-1398_1cb409cb-97ca-4601-b2fd-57baaf988070 63629-1398 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Bryant Ranch Prepack GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-1414_ec1c2692-67b0-43ba-9753-0d0492ad41d4 63629-1414 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20090701 ANDA ANDA075317 Bryant Ranch Prepack TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 63629-1415_24483c7e-571b-4493-a47a-108931957897 63629-1415 HUMAN PRESCRIPTION DRUG Isoniazid isoniazid SOLUTION ORAL 19831111 ANDA ANDA088235 Bryant Ranch Prepack ISONIAZID 50 mg/5mL Antimycobacterial [EPC] E 20171231 63629-1418_0d0a2a4e-d86c-4ac5-86c1-6902b6625a1f 63629-1418 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100730 NDA NDA018851 Bryant Ranch Prepack INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-1422_8b8b9ef0-abac-4cb6-bfab-f47368aad901 63629-1422 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19810714 ANDA ANDA087425 Bryant Ranch Prepack ISONIAZID 300 mg/1 Antimycobacterial [EPC] E 20171231 63629-1423_0fa353d9-d36b-43bd-9393-419d5b96c413 63629-1423 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 63629-1424_ed23a534-fcb9-4cb5-82b2-976cb524ab9f 63629-1424 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 63629-1434_39b5849c-2278-47dd-9eee-f65580174ffe 63629-1434 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Bryant Ranch Prepack FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63629-1435_eb506f38-45d0-4cbf-9850-aa3cae3df037 63629-1435 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19870827 ANDA ANDA070082 Bryant Ranch Prepack FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 63629-1446_86fcd130-b644-41c0-b2f9-218fbe5b94fb 63629-1446 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-1447_a2c7c9d6-7442-49b5-8cc4-8b443df33aa2 63629-1447 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 63629-1452_ea138d75-810f-403a-ad7b-dd705feeb9d5 63629-1452 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 Bryant Ranch Prepack LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 63629-1459_8321224c-f3bf-4150-9e5b-6f0f2a9382df 63629-1459 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 19701125 ANDA ANDA080043 Bryant Ranch Prepack NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 63629-1464_fe7ed67c-2a28-47e7-9941-0b5a724dfdf1 63629-1464 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20090615 ANDA ANDA075551 Bryant Ranch Prepack LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-1467_5f0df3aa-7a95-46f8-a550-4131d6226e94 63629-1467 HUMAN PRESCRIPTION DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 20040101 ANDA ANDA075010 Bryant Ranch Prepack IBUPROFEN 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-1468_95624fa6-2509-460b-b7b4-7879ef222a71 63629-1468 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Bryant Ranch Prepack IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-1469_1002f565-4865-4110-a26d-f6b9bda6d5ff 63629-1469 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Bryant Ranch Prepack IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-1470_90b9a65a-708d-4c29-9111-980096de480f 63629-1470 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Bryant Ranch Prepack IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-1476_2727182e-096e-4dcf-8a5e-b933230e7928 63629-1476 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20040114 ANDA ANDA076494 Bryant Ranch Prepack NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-1477_07322620-6df4-436a-a7f3-6b9ab2975eec 63629-1477 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Bryant Ranch Prepack NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-1485_08aac1dc-f0de-4e49-bae8-b7f9d35fb8c6 63629-1485 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075273 Bryant Ranch Prepack KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63629-1491_7285f0a3-210a-4798-8236-2f5020c2fd15 63629-1491 HUMAN PRESCRIPTION DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 19941001 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 63629-1494_03423596-4d58-4fa2-aaf6-f04d61e6b7c2 63629-1494 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19900930 ANDA ANDA088628 Bryant Ranch Prepack ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 63629-1495_773fce44-d245-4e4c-8bae-f0372573f093 63629-1495 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20031206 ANDA ANDA074463 Bryant Ranch Prepack CIMETIDINE 800 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 63629-1497_0e6e4e6d-6379-4d7a-9a0e-d6aec5fec321 63629-1497 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20040202 ANDA ANDA074151 Bryant Ranch Prepack CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63629-1501_b4e872f7-3537-465c-a2b6-c6e43495197a 63629-1501 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100323 ANDA ANDA060704 Bryant Ranch Prepack TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 63629-1502_986919c1-2f86-4dee-b487-f0e8bf45ba58 63629-1502 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20101219 ANDA ANDA061837 Bryant Ranch Prepack TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 63629-1507_bb98d1e9-73aa-4e61-bbe8-ac5ab57a01c2 63629-1507 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19970605 ANDA ANDA074821 Bryant Ranch Prepack TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63629-1513_bac3411a-00df-4d1e-8059-3247c32614df 63629-1513 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072192 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63629-1514_e171b164-453b-43ed-a4d6-2b031dbbb5a7 63629-1514 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 Bryant Ranch Prepack FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 63629-1516_36f5f2c5-780b-4c09-9269-935f522528bd 63629-1516 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH FINAL part343 Bryant Ranch Prepack ACETAMINOPHEN 500 mg/1 E 20171231 63629-1518_f11b14ce-1cc6-41eb-a037-cc5adca20f0f 63629-1518 HUMAN PRESCRIPTION DRUG Regular Strength QPAP Acetaminophen TABLET ORAL 19960201 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ACETAMINOPHEN 325 mg/1 E 20171231 63629-1522_6d661b2c-ce39-4db4-b1ae-c0fd16089917 63629-1522 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Bryant Ranch Prepack ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63629-1523_9e93b792-ca23-470d-9afa-2e43396a4dd0 63629-1523 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071321 Bryant Ranch Prepack DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-1525_13feb698-01ad-4e1d-8971-a9666c701d02 63629-1525 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20050105 ANDA ANDA075483 Bryant Ranch Prepack ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63629-1526_5c0a90c5-cf9a-413c-9f32-5bea9dba032a 63629-1526 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Bryant Ranch Prepack ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63629-1528_bfc340bf-ba64-48c8-ad77-ae8365375273 63629-1528 HUMAN PRESCRIPTION DRUG Mebendazole Mebendazole TABLET, CHEWABLE ORAL 20100428 ANDA ANDA073580 Bryant Ranch Prepack MEBENDAZOLE 100 mg/1 Antihelminthic [EPC] E 20171231 63629-1531_46df06d6-0c30-4b6e-b7da-d67a19a0ff10 63629-1531 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 Bryant Ranch Prepack DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 63629-1534_455bef84-be0c-4e9f-913b-4bb3c62cfabf 63629-1534 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Bryant Ranch Prepack DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-1535_3894ab46-7ea9-48ed-b504-69cc68b0c408 63629-1535 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Bryant Ranch Prepack DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-1536_bdfc482f-4553-44f8-b681-a3ec471f34fe 63629-1536 HUMAN PRESCRIPTION DRUG VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63629-1541_76f07536-e338-4984-ba2a-148ce9c5a92d 63629-1541 HUMAN PRESCRIPTION DRUG ALPRAZOLAM EXTENDED-RELEASE ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 Bryant Ranch Prepack ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-1559_4d0c14a7-3af6-45fc-bcd3-5e62b5566e46 63629-1559 HUMAN PRESCRIPTION DRUG Nifedical XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20010209 ANDA ANDA075289 Bryant Ranch Prepack NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63629-1560_cc68aa62-5057-4fb7-8c1f-a986a310d1e1 63629-1560 HUMAN PRESCRIPTION DRUG Nifedical XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20001211 ANDA ANDA075289 Bryant Ranch Prepack NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63629-1561_43172b4d-31c3-4c1f-a8ef-cba1adfc75ba 63629-1561 HUMAN PRESCRIPTION DRUG Nifediac CC Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020916 ANDA ANDA076070 Bryant Ranch Prepack NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63629-1564_2b14b457-9a6b-48c6-b83a-79b526eac0bd 63629-1564 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Bryant Ranch Prepack ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63629-1565_4532546c-34cf-4648-9b26-bd6c278ce4af 63629-1565 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070524 ANDA ANDA076719 Bryant Ranch Prepack AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63629-1566_1dbf7a3b-0e6b-43e7-a59d-d11c80b4a153 63629-1566 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070524 ANDA ANDA076719 Bryant Ranch Prepack AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63629-1572_06e94b40-95e3-4740-96d3-6e3bbdb28167 63629-1572 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Bryant Ranch Prepack GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-1584_371bf6a6-b185-453a-83d1-ade7e3b971a9 63629-1584 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20020104 ANDA ANDA040377 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 63629-1587_dffb3da1-b9a7-4c25-a143-0880cb865d37 63629-1587 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 Bryant Ranch Prepack PREDNISONE 20 mg/1 N 20181231 63629-1591_9b772970-89cf-4ee6-88de-0337c4438a67 63629-1591 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63629-1596_1a77b82d-51b3-4a47-bc3b-da51379df518 63629-1596 HUMAN PRESCRIPTION DRUG PLENDIL Felodipine TABLET, EXTENDED RELEASE ORAL 19910916 NDA NDA019834 Bryant Ranch Prepack FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63629-1597_290fe174-0128-46e2-ae85-15b23717807f 63629-1597 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Bryant Ranch Prepack FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63629-1603_64eb4f58-700c-41f5-b35e-a1fb35df423d 63629-1603 HUMAN PRESCRIPTION DRUG PROPECIA finasteride TABLET, FILM COATED ORAL 19971219 NDA NDA020788 Bryant Ranch Prepack FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 63629-1604_281377de-81c3-4fec-96e9-7b426190c3f9 63629-1604 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20090601 ANDA ANDA085588 bryant ranch prepack PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII E 20171231 63629-1605_3e8fc95e-fc37-4c66-b47c-1f5ef9021a8f 63629-1605 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Bryant Ranch Prepack PREDNISONE 5 mg/1 N 20181231 63629-1606_f30fb7e7-9848-4c13-bb52-a33b02edea8e 63629-1606 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Bryant Ranch Prepack PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-1607_ca56e5cd-711e-4ae9-a826-2dcd3ff15ebf 63629-1607 HUMAN PRESCRIPTION DRUG Prometh with Codeine promethazine hydrochloride and codeine phosphate SYRUP ORAL 20030103 ANDA ANDA088763 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV E 20171231 63629-1609_3976c106-a84d-4a66-84b8-9a44b0487c66 63629-1609 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Bryant Ranch Prepack FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-1610_edb87025-c771-465a-b782-b25d381dac79 63629-1610 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Bryant Ranch Prepack FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-1611_c0e75c8e-43da-4606-8cbf-445b08297c35 63629-1611 HUMAN PRESCRIPTION DRUG PROVIGIL Modafinil TABLET ORAL 19990215 NDA NDA020717 Bryant Ranch Prepack MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 63629-1616_a822acd2-c3ec-464d-96ae-0133293198d8 63629-1616 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl Phenazopyridine HCl TABLET ORAL 20100910 UNAPPROVED DRUG OTHER Bryant Ranch Prepack PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 63629-1619_e54e849f-a158-42b3-8da4-bb342af3a77c 63629-1619 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 Bryant Ranch Prepack TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 63629-1620_34f11e5e-fb92-48a1-a002-24a4a3ca6ca5 63629-1620 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Bryant Ranch Prepack NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-1621_eac8c883-2981-4093-8a9b-5a4df3a1d658 63629-1621 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 Bryant Ranch Prepack TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 63629-1622_4d301f55-e1c0-4c91-970d-8ae0f9914d37 63629-1622 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Bryant Ranch Prepack METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63629-1623_2f6a5693-afb3-483d-8eca-19142d7c58df 63629-1623 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Bryant Ranch Prepack METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63629-1639_7ecaa07a-cd7b-4173-b028-10fd871545e3 63629-1639 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 19980220 NDA NDA020829 Bryant Ranch Prepack MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 63629-1647_161babcb-e8fa-4e84-9c5b-b2df3d7c8088 63629-1647 HUMAN PRESCRIPTION DRUG SPORANOX ITRACONAZOLE CAPSULE ORAL 19920911 NDA NDA020083 Bryant Ranch Prepack ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63629-1671_f28e64fb-860b-4b4b-b942-044eda57017c 63629-1671 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Bryant Ranch Prepack RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63629-1673_fef65538-e216-45b9-8e07-2adcb30466bf 63629-1673 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Bryant Ranch Prepack TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 63629-1675_39097f31-0847-47bb-8732-55c612ad136b 63629-1675 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018832 Bryant Ranch Prepack ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 63629-1676_ec58af2d-1415-47a2-b03f-4af2001e6134 63629-1676 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970423 ANDA ANDA074578 Bryant Ranch Prepack ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 63629-1677_3a57e52b-f7a5-432a-8cbd-9b12b2a3bede 63629-1677 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 Bryant Ranch Prepack ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63629-1679_4aa1195b-7baa-41f9-9552-ed8a07ab9bb3 63629-1679 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA075776 Bryant Ranch Prepack LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63629-1706_fef176ea-8ed6-489c-a87a-ad418fdcdff5 63629-1706 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Bryant Ranch Prepack CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63629-1724_43fa48bf-0692-4623-b96c-bd96a02ee616 63629-1724 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Bryant Ranch Prepack CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63629-1734_bc68db15-84d3-4b6b-935c-50f6216cb456 63629-1734 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20000526 ANDA ANDA040357 Bryant Ranch Prepack DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 63629-1742_472bd6a1-f849-45db-b908-8b07335d8dc1 63629-1742 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63629-1747_d478fe31-e339-48e7-82da-f29199389d8a 63629-1747 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020301 ANDA ANDA075022 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 15 mg/1 E 20171231 63629-1748_a22976a5-8cbd-435d-b883-f385a971a957 63629-1748 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 20050406 ANDA ANDA077066 Bryant Ranch Prepack NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 63629-1761_3e34d8bf-ad2d-4546-ae3f-1ae5c990f329 63629-1761 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Bryant Ranch Prepack LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-1765_0d45cd06-d2c0-4f58-a698-432b982eb9ff 63629-1765 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Bryant Ranch Prepack SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 63629-1774_897a9638-3b16-46dd-bc8c-0a9cfcff31f6 63629-1774 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 Bryant Ranch Prepack BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII E 20171231 63629-1780_25f812ac-4395-4b24-be27-7ef34fce9f8c 63629-1780 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100710 NDA NDA018851 Bryant Ranch Prepack INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-1781_ed0244a1-86d9-4fd0-b649-a9f805416c0e 63629-1781 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018877 Bryant Ranch Prepack ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 63629-1783_a4a75cbd-84fc-44c9-869b-18554c9f7c0d 63629-1783 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20031124 ANDA ANDA074151 Bryant Ranch Prepack CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63629-1784_94311351-8b98-43d0-bd4b-568ad2e5c68e 63629-1784 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075551 Bryant Ranch Prepack LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-1785_45b2be2a-8160-46b8-94f2-9f8ed80899d6 63629-1785 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Bryant Ranch Prepack ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-1789_99e4f2a6-f509-4417-9554-875e44159f79 63629-1789 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20060714 OTC MONOGRAPH FINAL part336 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 63629-1792_5878597f-de7b-40a4-aa1f-fa5e1292c87c 63629-1792 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Bryant Ranch Prepack SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 63629-1793_5585711c-4a25-4b91-ab53-3fd2ff096054 63629-1793 HUMAN PRESCRIPTION DRUG Good Sense All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 19970114 ANDA ANDA079096 Bryant Ranch Prepack NAPROXEN SODIUM 220 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-1809_c5b571e0-b746-4ca5-9c37-ad63fde6bd5c 63629-1809 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-1823_45792772-964e-40b3-afd2-b3f205438515 63629-1823 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 63629-1830_cf28b82f-ae4f-4587-accd-beb029602b57 63629-1830 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 19860723 ANDA ANDA089424 Bryant Ranch Prepack SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 63629-1836_f0131449-7330-40f5-be8e-e536863c40e7 63629-1836 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073517 Bryant Ranch Prepack KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-1837_4ec87f23-15f6-4c43-ae20-6e6f541e8a09 63629-1837 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-1838_e0dee626-ef6b-2e8b-755c-5d931f6d8ab7 63629-1838 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-1839_4c036214-d9c2-4aa4-925b-cae6a9ffbe87 63629-1839 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-1840_996a5d5d-24e0-4c7a-b179-7d36e1fa7f33 63629-1840 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-1841_a648cb2b-59fd-468d-99d5-99eb5b7384ae 63629-1841 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 19980301 ANDA ANDA040268 Bryant Ranch Prepack PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63629-1842_8f4f3bfc-9eb7-4480-a39d-10f36549ada8 63629-1842 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-1856_70f9e3cc-b145-439b-be7f-b3074166e7aa 63629-1856 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20120324 ANDA ANDA204279 Bryant Ranch Prepack HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63629-1868_fb3a6213-a11f-4f64-8552-aaa11adbfcc9 63629-1868 HUMAN PRESCRIPTION DRUG Promethazine hydrochloride and phenylephrine hydrochloride Promethazine hydrochloride and phenylephrine hydrochloride SYRUP ORAL 20111219 ANDA ANDA088761 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 5 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] E 20171231 63629-2541_22d47bec-1025-49e8-9918-6451668ebc8d 63629-2541 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090911 ANDA ANDA074532 Bryant Ranch Prepack CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63629-2548_a476f5cf-43a3-4939-9014-7401fc1bd0d7 63629-2548 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Bryant Ranch Prepack WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 63629-2552_958a3e12-0f99-4989-9f85-4aa0f3ebb086 63629-2552 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20110707 ANDA ANDA040298 Bryant Ranch Prepack PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 63629-2570_f8af56d5-a474-4c69-94a7-4b8f7f6ad536 63629-2570 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 63629-2573_9bbe9b70-5747-4fbb-b6c4-b52533ab946c 63629-2573 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086066 Bryant Ranch Prepack ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 63629-2579_a44fcd44-72c5-455c-86de-ba8915d41513 63629-2579 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 Bryant Ranch Prepack DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 63629-2585_00100562-f2f0-42b2-b4f2-b2511ef59c9e 63629-2585 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA071851 Bryant Ranch Prepack TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-2593_7299d664-22c0-49a0-8e3a-8f25c7bdc0f9 63629-2593 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Bryant Ranch Prepack GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-2598_3810a365-4f0f-4b39-9219-89ff274534f6 63629-2598 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 19950415 ANDA ANDA062512 Bryant Ranch Prepack NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 63629-2607_46972231-db34-4444-bbea-7f07df5e6c00 63629-2607 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20030804 ANDA ANDA075876 Bryant Ranch Prepack OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63629-2612_ca1a28e0-ab7d-4d5b-8377-ca644b2a73b1 63629-2612 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Bryant Ranch Prepack MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 63629-2613_b4fa4647-6e1b-4885-898a-f011fc0d4617 63629-2613 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Bryant Ranch Prepack MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 63629-2614_eff960db-8225-4a8b-9812-a55073dd5f40 63629-2614 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961203 ANDA ANDA040159 Bryant Ranch Prepack MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 63629-2625_a0444d5e-aaee-4b25-90cf-d2f83abc69d7 63629-2625 HUMAN OTC DRUG Nasal Decongestant Pseudoephedrine HCl TABLET, SUGAR COATED ORAL 20110922 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 E 20171231 63629-2626_894c68d7-dde3-4272-a2b0-5a09fc9eda88 63629-2626 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Bryant Ranch Prepack ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-2636_48f8d6ec-e22c-42b2-ba90-2b90f97345e4 63629-2636 HUMAN OTC DRUG ACETAMINOPHEN 80 MG FRUIT CHEW ACETAMINOPHEN TABLET ORAL 20151101 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ACETAMINOPHEN 80 mg/1 N 20181231 63629-2638_d10e6624-f131-43a7-8b13-4430d36472cd 63629-2638 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 19891205 ANDA ANDA072637 Bryant Ranch Prepack ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 63629-2640_e250557d-a9bd-469a-9abb-0fee2b2848fc 63629-2640 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Bryant Ranch Prepack SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 63629-2642_fbf3092b-2061-4bf5-899a-c412814fd8b5 63629-2642 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 63629-2647_b6df4e0f-2d3b-474e-b9ef-f1a89f5e8875 63629-2647 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19920430 ANDA ANDA073281 Bryant Ranch Prepack TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63629-2653_f237a097-c02e-4e1a-b1af-a1d38b4c2764 63629-2653 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 Bryant Ranch Prepack FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 63629-2655_ccb3093d-1b48-4c18-bb54-83e72b7c7b12 63629-2655 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 19930401 ANDA ANDA081297 Bryant Ranch Prepack BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 63629-2672_c599f21f-a770-4ed2-bd7f-b3bcb18d75d6 63629-2672 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63629-2679_291c1714-82f6-42f1-be69-d1011eb668b1 63629-2679 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63629-2680_89fee21e-685d-42a6-b46c-fefa4b92e6f8 63629-2680 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-2681_a2e36bef-667f-423e-9ef6-90989e087400 63629-2681 HUMAN PRESCRIPTION DRUG Amantadine HCl Amantadine hydrochloride CAPSULE ORAL 20081101 ANDA ANDA078720 Bryant Ranch Prepack AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 63629-2682_746fd153-22f2-4b5c-8c46-0e8d5f8e6f62 63629-2682 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Bryant Ranch Prepack NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-2683_2d86a995-a07a-45e3-8039-1c5f8f84222a 63629-2683 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Bryant Ranch Prepack FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63629-2688_30c43307-f4fc-4bcf-bd2c-f3ede1289b9a 63629-2688 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 Bryant Ranch Prepack LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-2697_ae42f917-1065-cabd-15a1-4fd12036460d 63629-2697 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-2703_9d06e39b-321d-4814-8580-29fa5a9fc235 63629-2703 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 Bryant Ranch Prepack POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 63629-2712_268ee0b4-8a79-46f8-b0ac-c352539c205a 63629-2712 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-2718_054200f7-a059-c63f-edb0-c43a4ac202bb 63629-2718 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-2724_d6e1c309-eb3a-4354-8a3b-bb4f603844ca 63629-2724 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-2727_95087193-78b4-4aa0-a115-f53f8ccb45dd 63629-2727 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 63629-2733_dd3f3642-50cf-4f60-9031-64f5d0826f30 63629-2733 HUMAN PRESCRIPTION DRUG AcipHex rabeprazole sodium TABLET, COATED ORAL 19990819 NDA NDA020973 Bryant Ranch Prepack RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 63629-2734_bc988476-f780-41dd-8b41-b7b0c9abfe87 63629-2734 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Bryant Ranch Prepack TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 63629-2735_053be5d6-ae87-4fb4-911d-e692e8b2b74a 63629-2735 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride and Hydrochlorothiazide Benazepril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20040211 ANDA ANDA076631 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63629-2736_421c0535-c26d-444f-84ce-0b02ccc8b854 63629-2736 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 19891205 ANDA ANDA072637 Bryant Ranch Prepack ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 63629-2745_6ef8e4ea-1f0b-488c-8c69-13b77a33702d 63629-2745 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20000530 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 63629-2753_54d5cefd-693a-4fa5-808d-9a4de3d42f6f 63629-2753 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070924 Bryant Ranch Prepack CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63629-2756_c78cd7fb-7f9b-4b67-ad43-6b779b7e53a5 63629-2756 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Bryant Ranch Prepack CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63629-2759_5f0d0ca8-c746-47e0-a4be-26a77361a8d9 63629-2759 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Bryant Ranch Prepack MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 63629-2766_87a5b882-3fa1-4ecc-9704-d3ce3b514b27 63629-2766 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Bryant Ranch Prepack ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 63629-2767_cdc6143b-d484-4a68-b85b-4b896a77944c 63629-2767 HUMAN PRESCRIPTION DRUG Prometrium Progesterone CAPSULE ORAL 20100730 NDA NDA019781 Bryant Ranch Prepack PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 63629-2768_8d252917-8e68-4469-9ce5-4db07942920c 63629-2768 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 Bryant Ranch Prepack METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 63629-2769_05ff440b-b378-4557-b616-d3c600f13001 63629-2769 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20050915 ANDA ANDA077314 Bryant Ranch Prepack NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 63629-2770_26a5f310-536e-4b9c-b60d-3471df109c88 63629-2770 HUMAN PRESCRIPTION DRUG Prometrium Progesterone CAPSULE ORAL 20100730 NDA NDA019781 Bryant Ranch Prepack PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 63629-2782_f4b79fa7-8ca1-4513-b770-76c4228dcfea 63629-2782 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Bryant Ranch Prepack FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63629-2792_a9c6fff9-af5b-4a8d-98d8-79244850e043 63629-2792 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089808 Bryant Ranch Prepack THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 63629-2793_3c5c4fd3-ed2d-4c73-8aa7-4d32ece8b9b4 63629-2793 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20070614 ANDA ANDA076345 Bryant Ranch Prepack GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 63629-2796_66489b40-5d11-42e6-9fc3-0ed1e098d33a 63629-2796 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Bryant Ranch Prepack MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 63629-2798_8e6594e2-8d36-4b9b-8c32-d48a5f11d9a9 63629-2798 HUMAN PRESCRIPTION DRUG Zyrtec Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20081001 NDA NDA019835 Bryant Ranch Prepack CETIRIZINE HYDROCHLORIDE 10 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 63629-2806_670abf0d-5cad-8ac3-306c-c5d24616f076 63629-2806 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-2807_b2390a9a-f3d6-4b65-9949-706ae0161bff 63629-2807 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20110101 ANDA ANDA077533 Bryant Ranch Prepack TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] E 20171231 63629-2816_4e8b284d-6e8c-4992-80d1-7959d6ddbea6 63629-2816 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 Bryant Ranch Prepack FOLIC ACID 1 mg/1 N 20181231 63629-2817_ff14ce02-8b7a-4c33-9513-d2d263da18ee 63629-2817 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19910731 ANDA ANDA063083 Bryant Ranch Prepack CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63629-2825_563c4e29-44b9-4fa0-9420-e29be719c45b 63629-2825 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20080428 OTC MONOGRAPH FINAL part343 Bryant Ranch Prepack ASPIRIN 81 mg/1 E 20171231 63629-2833_9117b948-758c-4f51-9b44-bf8624d56e81 63629-2833 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073554 Bryant Ranch Prepack NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-2844_cdb17887-1677-4c46-9afe-c1dc9b5964dd 63629-2844 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20010326 NDA NDA019962 Bryant Ranch Prepack METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 63629-2867_5e333cad-fba0-4d55-b2f5-7c80b949f46f 63629-2867 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 63629-2873_763ec70c-b853-4664-a648-74046636e1b2 63629-2873 HUMAN PRESCRIPTION DRUG BUDEPRION SR BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20040323 ANDA ANDA075913 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 63629-2882_c33f0727-28e2-44f4-b423-079afec4f805 63629-2882 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070176 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-2883_0b6f5ec8-bfae-4ed4-bbe1-a4623aee3aef 63629-2883 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63629-2884_3f9d359f-43f9-4f42-98d3-df3b7a6cc702 63629-2884 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Bryant Ranch Prepack VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-2887_4e1dfc50-def7-4864-8acb-f0cf551c01e2 63629-2887 HUMAN PRESCRIPTION DRUG Clarithromycin clarithromycin TABLET, COATED ORAL 20040525 ANDA ANDA065178 Bryant Ranch Prepack CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63629-2904_ad4b6bf7-46f5-4d2d-9c56-2406added089 63629-2904 HUMAN OTC DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20100806 ANDA ANDA090837 Bryant Ranch Prepack FAMOTIDINE 20 mg/1 N 20181231 63629-2907_add7bb8e-5929-4ab9-854d-18b52784b7e2 63629-2907 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 Bryant Ranch Prepack GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 63629-2908_09189b20-3bfa-41dc-b715-90191d508307 63629-2908 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Bryant Ranch Prepack LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63629-2909_0b6838fb-0b21-4fdf-8294-a390d46330f3 63629-2909 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Bryant Ranch Prepack ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 63629-2910_94d54ea8-b355-4bbf-abbe-e16bbb23d9b4 63629-2910 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 19990610 ANDA ANDA075191 Bryant Ranch Prepack PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] E 20171231 63629-2912_b3441dee-4369-461d-9868-798de86960fa 63629-2912 HUMAN PRESCRIPTION DRUG COZAAR losartan potassium TABLET, FILM COATED ORAL 19950414 NDA NDA020386 Bryant Ranch Prepack LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-2923_1c7bdc39-e1c3-47e1-8045-2dee0ea0f349 63629-2923 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 63629-2924_39f435cb-7f5e-4e9b-b8af-4a833972a23f 63629-2924 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20030318 ANDA ANDA063083 Bryant Ranch Prepack CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63629-2926_a7dd1e4b-35d6-443d-b78a-1b3bb53fcd58 63629-2926 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-2935_00e1cb3e-0f7e-45ed-9bf8-5c176bb10ec3 63629-2935 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076063 Bryant Ranch Prepack LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-2937_8370ab54-b466-419b-b7e0-fae800eeee7b 63629-2937 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Bryant Ranch Prepack POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 63629-2942_c89986aa-e7a2-46ed-9df5-784a1bd7e09d 63629-2942 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080402 ANDA ANDA074342 Bryant Ranch Prepack ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-2945_7a7e65ab-d1df-477e-b163-b7e211eb4c0b 63629-2945 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 19900930 ANDA ANDA088627 Bryant Ranch Prepack ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 63629-2948_9bae1cd3-8c26-4a16-8a18-42ebab93895a 63629-2948 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071307 Bryant Ranch Prepack DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-2949_b2e895f6-8071-43bb-a7e0-0abccb48a7ba 63629-2949 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 63629-2950_de73523c-c3dc-4800-9fd2-c09b550ca216 63629-2950 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE phentermine hydrochloride CAPSULE ORAL 19970428 ANDA ANDA040886 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 63629-2951_21f2cd35-3257-4a6a-acfe-a88e6bc78577 63629-2951 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 19790605 ANDA ANDA086162 Bryant Ranch Prepack BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII E 20171231 63629-2952_7186a3df-f11f-462f-9441-a2e94406382d 63629-2952 HUMAN PRESCRIPTION DRUG BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE Butalbital, Aspirin, Caffeine and Codeine Phosphate CAPSULE ORAL 20090501 ANDA ANDA075231 Bryant Ranch Prepack BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 63629-2953_36500e56-63d3-4633-834a-59144fa0af5d 63629-2953 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072926 Bryant Ranch Prepack LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-2954_6cae0f10-4123-4142-9a2c-3e225bed9411 63629-2954 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072928 Bryant Ranch Prepack LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-2955_0177343b-a353-403f-a36f-5c4656ab98ae 63629-2955 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Bryant Ranch Prepack ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-2956_1f66adbd-5b36-4c4b-be88-c0d6f545e1d9 63629-2956 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 19940601 ANDA ANDA074224 Bryant Ranch Prepack TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-2959_1cf8a80f-61ff-4aa7-a564-14df1409a4aa 63629-2959 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP ORAL 20111219 ANDA ANDA088764 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 5; 10 mg/5mL; mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV E 20171231 63629-2967_33504ad1-03b6-49d1-9408-c6cff0bb2818 63629-2967 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 19601117 NDA NDA012546 Bryant Ranch Prepack DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 63629-2974_f439d49c-20cb-4a07-8112-76105576a6f1 63629-2974 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 Bryant Ranch Prepack KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 63629-2979_ab8e2247-7a40-45d7-9ef9-e6fe64433f40 63629-2979 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Bryant Ranch Prepack MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 63629-2981_f54b8657-2554-4872-b679-eeccaa3fe9b9 63629-2981 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Bryant Ranch Prepack ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-2982_bd26a453-8c3e-4fe3-951f-eb43429c9cd4 63629-2982 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20090123 ANDA ANDA087056 Bryant Ranch Prepack CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 63629-3021_db407204-29d3-4293-b8e8-49a481b26405 63629-3021 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Bryant Ranch Prepack CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-3031_30a4984a-ef37-4ae0-9499-6833bac3d8ee 63629-3031 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20091117 ANDA ANDA040419 Bryant Ranch Prepack ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 63629-3034_b0d67e64-c14c-44d0-abb6-312fd2eb0f90 63629-3034 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA077107 Bryant Ranch Prepack FLURAZEPAM HYDROCHLORIDE 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-3043_eae8e5c0-3f7b-4219-affa-e2d9294128c3 63629-3043 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Bryant Ranch Prepack GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-3047_947b3d24-75cf-4d7d-8b3d-84e5b29b19be 63629-3047 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 63629-3049_2be4867b-cb90-4c80-a482-d0c4f2221a5d 63629-3049 HUMAN OTC DRUG Enteric Coated Stimulant Laxative Bisacodyl TABLET, DELAYED RELEASE ORAL 20110922 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack BISACODYL 5 mg/1 E 20171231 63629-3051_0d5edc89-3291-4473-9e27-5cbcaafc81c7 63629-3051 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 Bryant Ranch Prepack PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII E 20171231 63629-3052_bf33275d-634b-4749-b5cd-d05f5e026bfe 63629-3052 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19920801 ANDA ANDA073568 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63629-3056_ec89daf8-b5b3-4f56-b80a-acd58d2ea086 63629-3056 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Bryant Ranch Prepack GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-3063_d6fd3196-8f03-44ae-b1a9-6fba4fd5e9e8 63629-3063 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Bryant Ranch Prepack GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-3066_49185987-903d-48e9-93d7-a6f11c5aeeae 63629-3066 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN TABLET ORAL 20090605 ANDA ANDA090177 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-3141_5fb4a750-ce07-07e3-f66a-46b027d5d03c 63629-3141 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20090630 NDA NDA021774 Bryant Ranch Prepack ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 63629-3142_ca386c45-4609-4bff-9bab-bdf0b879a7e4 63629-3142 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Bryant Ranch Prepack ESZOPICLONE 3 mg/1 CIV E 20171231 63629-3152_ea2a6373-9e70-46a8-9736-22d024774f56 63629-3152 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE ORAL 20030918 NDA AUTHORIZED GENERIC NDA020232 Bryant Ranch Prepack BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 63629-3158_246c7654-2097-4ecc-b316-a65e399eacf0 63629-3158 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031107 ANDA ANDA076467 Bryant Ranch Prepack GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-3166_9def4c06-4105-4727-97d4-18ffef353f92 63629-3166 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 19551231 NDA AUTHORIZED GENERIC NDA010187 Bryant Ranch Prepack METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 63629-3177_ac023bc0-7ff5-4656-89f6-1e996fd855a9 63629-3177 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Bryant Ranch Prepack WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 63629-3183_5b526cb3-c4db-4b7c-9242-2c460d3e3e8d 63629-3183 HUMAN PRESCRIPTION DRUG HYZAAR losartan potassium and hydrochlorothiazide TABLET, FILM COATED ORAL 19950428 NDA NDA020387 Bryant Ranch Prepack LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-3184_665fcdc8-8c05-4834-a513-2c14aff2f75a 63629-3184 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 650 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 63629-3190_0d3edcf8-7252-44e8-a586-f68bc575e6ee 63629-3190 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20060412 ANDA ANDA076502 Bryant Ranch Prepack FEXOFENADINE HYDROCHLORIDE 180 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 63629-3193_d418c769-56b0-46bc-8f4b-acb0334e4fd9 63629-3193 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077068 Bryant Ranch Prepack BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 63629-3196_9c4ec148-0a56-4c59-afaf-0d80e36f27a2 63629-3196 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100719 ANDA ANDA077455 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63629-3197_89c34c1a-81da-49a5-99ad-a477c9c1546b 63629-3197 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 5 mg/1 E 20171231 63629-3198_5c3d200b-d3b6-4219-80c2-af55437a7f50 63629-3198 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20000425 ANDA ANDA075074 Bryant Ranch Prepack ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-3199_ce25d056-5448-448e-a1d5-48f0c7daf054 63629-3199 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Bryant Ranch Prepack DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-3200_02846d2c-a5d8-4e35-b416-0f06e3f403e4 63629-3200 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 19861208 ANDA ANDA071108 Bryant Ranch Prepack FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63629-3201_446cd310-4607-4ac8-9a5d-a9bc4fecdf0a 63629-3201 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20101206 ANDA ANDA091549 Bryant Ranch Prepack INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-3202_dc562630-425b-4a9c-b2aa-021df34aa6db 63629-3202 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Bryant Ranch Prepack NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-3204_718fc3d1-961f-47ff-9da7-cff5cc61d27a 63629-3204 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Bryant Ranch Prepack NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63629-3205_d45cc5a0-eb7d-4e43-853a-1b56e1ebbf26 63629-3205 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63629-3206_239d7d15-f00c-4fc0-abcb-530f039ea6df 63629-3206 HUMAN PRESCRIPTION DRUG Pentazocine and naloxone Pentazocine hydrochloride and naloxone hydrochloride TABLET ORAL 19970121 ANDA ANDA074736 Bryant Ranch Prepack PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 50; .5 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIV E 20171231 63629-3207_5a42b29a-d47a-4c3e-aeeb-d93415d715f9 63629-3207 HUMAN PRESCRIPTION DRUG Senna-Lax SENNOSIDES A AND B TABLET, FILM COATED ORAL 20110504 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack SENNOSIDES A AND B 8.6 mg/1 E 20171231 63629-3208_84ebe033-77ac-4b35-89c7-aeb8a6b6e2aa 63629-3208 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071795 Bryant Ranch Prepack SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 63629-3209_7e0c3d11-daf9-43fa-8292-5608bbc76b6b 63629-3209 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Bryant Ranch Prepack TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63629-3210_1f699327-b323-4b1e-9d63-99c45065b4f1 63629-3210 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63629-3211_6f5c7a75-e1fd-40c4-b11c-f3b04f71e6b3 63629-3211 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120815 ANDA ANDA040887 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 63629-3213_46cf4dc6-32f8-47d6-95c0-3de5b5b2fa78 63629-3213 HUMAN OTC DRUG EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack DOCUSATE SODIUM 250 mg/1 E 20171231 63629-3217_af9fe725-452d-4ec2-8ff1-d88ad95bad52 63629-3217 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20010918 ANDA ANDA075788 Bryant Ranch Prepack ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63629-3221_3d6e6c23-8d9c-4cea-9a97-c092faf5071c 63629-3221 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Bryant Ranch Prepack DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-3226_6c27a8e1-c7ed-4b63-8285-9d1745564f39 63629-3226 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20111003 ANDA ANDA075768 Bryant Ranch Prepack BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63629-3233_1dde7b0b-c57e-4206-9759-5f60fd91e1b2 63629-3233 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63629-3243_66f66c9c-7fde-45cd-af65-cb9a4fe690b8 63629-3243 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20020710 ANDA ANDA076095 Bryant Ranch Prepack MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 63629-3248_13766e14-3a4c-4ea0-bc43-d57037662cf4 63629-3248 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 Bryant Ranch Prepack MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-3279_3d40a0bf-21c0-423b-bff8-e8b719345b9e 63629-3279 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20100201 ANDA ANDA040300 bryant ranch prepack METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 63629-3289_0fb46900-eeb8-449b-8778-9a1af34acd98 63629-3289 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-3291_ba95f1da-be23-4b47-857d-0404b6394a97 63629-3291 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 Bryant Ranch Prepack QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-3292_ccc9555d-f920-4641-b66b-aff461844473 63629-3292 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 Bryant Ranch Prepack PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 63629-3293_9bf67169-ce7a-4ea5-a6fb-78dd37863c62 63629-3293 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060317 ANDA ANDA077634 Bryant Ranch Prepack ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63629-3294_7f681908-40e9-460d-85f5-7c432af30514 63629-3294 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Bryant Ranch Prepack TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63629-3296_c17c4def-94a7-4f32-a853-aa3770288b9e 63629-3296 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Bryant Ranch Prepack RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20191231 63629-3299_ccc9555d-f920-4641-b66b-aff461844473 63629-3299 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 Bryant Ranch Prepack PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 63629-3301_1447369e-b9af-4f1f-bab8-9e0645071227 63629-3301 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 19981002 NDA NDA020998 Bryant Ranch Prepack CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-3302_a1847d9b-4d7e-42d6-b621-631416136124 63629-3302 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Bryant Ranch Prepack OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 63629-3308_a372953f-4c60-4ac9-90b4-650e5f691b75 63629-3308 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Bryant Ranch Prepack ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-3309_cb99e18b-0d04-43a2-b13c-8ab71ea10d35 63629-3309 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-3311_70584b50-54a4-42ed-84d8-3378ce4d7f6b 63629-3311 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 Bryant Ranch Prepack ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 63629-3312_8b187f73-dffa-4865-a87c-847bbcf77adb 63629-3312 HUMAN PRESCRIPTION DRUG FLUOXETINE fluoxetine hydrochloride CAPSULE ORAL 20081014 ANDA ANDA076922 Bryant Ranch Prepack FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-3313_41539934-9a65-4351-b47e-8589b8538dc5 63629-3313 HUMAN PRESCRIPTION DRUG Sertraline hydrochloride Sertraline hydrochloride TABLET, FILM COATED ORAL 20070905 ANDA ANDA077765 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63629-3314_d283d5e7-5d1d-45c3-a72f-9cec00f19d4b 63629-3314 HUMAN PRESCRIPTION DRUG Effexor XR VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63629-3316_011a5f64-801b-4998-8731-c9c26a2dab67 63629-3316 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081126 ANDA ANDA077715 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 63629-3317_c048443e-5c83-4dd0-96f4-8f49ebbd7274 63629-3317 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20150529 ANDA ANDA077032 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-3318_3df3631f-a55e-4e53-b09a-48ef4b66ea52 63629-3318 HUMAN PRESCRIPTION DRUG Lexapro ESCITALOPRAM OXALATE TABLET, FILM COATED ORAL 20020814 NDA NDA021323 Bryant Ranch Prepack ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-3319_22615468-026e-4984-b3b8-a7870dd34469 63629-3319 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20030630 NDA NDA020639 Bryant Ranch Prepack QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-3321_239edb0e-3f65-4419-b88f-f6eba4890bf7 63629-3321 HUMAN PRESCRIPTION DRUG Topamax topiramate TABLET, COATED ORAL 19970101 NDA NDA020505 Bryant Ranch Prepack TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 63629-3323_3d36ecb5-4c38-43df-b3e2-a3dad6056d74 63629-3323 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63629-3324_e74f2f02-ec1b-4fb6-9d9c-ea1718fe3dcf 63629-3324 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-3325_db8e2ebe-8abf-41fe-b9f3-2c7d9a2a5826 63629-3325 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-3326_ec0d9c75-117a-4932-904a-ca6f8f273dd9 63629-3326 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Bryant Ranch Prepack MIRTAZAPINE 30 mg/1 N 20181231 63629-3328_13766e14-3a4c-4ea0-bc43-d57037662cf4 63629-3328 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Bryant Ranch Prepack MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-3330_6a2a058f-0c6c-4a06-b961-3c754b1fbb61 63629-3330 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 Bryant Ranch Prepack PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 63629-3332_c5d09924-e081-4721-8f60-f81197efac00 63629-3332 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041203 ANDA ANDA076711 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63629-3333_ff531dfd-6fd3-4a4c-b214-dd1fa8558855 63629-3333 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20040326 ANDA ANDA075022 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 63629-3337_ec4cd107-382c-fa0c-41a4-15bce73182f0 63629-3337 HUMAN PRESCRIPTION DRUG Ambien CR zolpidem tartrate TABLET, COATED ORAL 20090630 NDA NDA021774 Bryant Ranch Prepack ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 63629-3338_926e738e-f3b2-4265-9083-cbb76ecd57ae 63629-3338 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20150529 ANDA ANDA077032 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-3339_34994f6c-2a04-44ca-b48e-0d26b4d126e9 63629-3339 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Bryant Ranch Prepack CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63629-3340_61ae61bf-2046-4cdb-a8fb-ab29f975c918 63629-3340 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20100115 NDA NDA021427 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-3341_f61bdede-243e-4bfe-9772-059c8103c96c 63629-3341 HUMAN PRESCRIPTION DRUG dicyclomine hydrochloride dicyclomine hydrochloride CAPSULE ORAL 19970228 ANDA ANDA040204 Bryant Ranch Prepack DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 63629-3343_c4070400-b81f-451e-9fd7-83fd26010ef4 63629-3343 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 Bryant Ranch Prepack HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] E 20171231 63629-3344_d3768f5e-f8a7-434a-a53b-4b4ac80d74b2 63629-3344 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078385 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-3345_eebf7b49-bb69-43be-8d39-e77ff4fa17d2 63629-3345 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 Bryant Ranch Prepack MIRTAZAPINE 15 mg/1 N 20181231 63629-3346_b2d035f1-e60f-49f1-95f5-24ee250a551e 63629-3346 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 Bryant Ranch Prepack MIRTAZAPINE 45 mg/1 N 20181231 63629-3347_14506e4a-c387-4e81-9a5a-5d75882a555c 63629-3347 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20010319 NDA NDA021153 Bryant Ranch Prepack ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 63629-3348_2974b1cf-8586-4234-b7cf-d438c3692dd7 63629-3348 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63629-3349_b1c510a2-6077-4cd4-b87c-e5f876f57164 63629-3349 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-3352_716daf76-5d5c-4a8b-9cfe-e465555851e8 63629-3352 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 19950510 NDA NDA020406 Bryant Ranch Prepack LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 63629-3353_e0de4498-cabf-44b6-b067-52756eef0577 63629-3353 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071219 ANDA ANDA077056 Bryant Ranch Prepack PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 63629-3354_3276b534-fe02-4c14-896b-06da671494ea 63629-3354 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Bryant Ranch Prepack RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-3355_e6145216-e417-43b1-bca3-da2e61393567 63629-3355 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Bryant Ranch Prepack RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-3357_33de868b-a3bc-49ae-bc2f-ce8cc9768314 63629-3357 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Bryant Ranch Prepack OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 63629-3359_8840099e-7072-474e-8a60-c428b7df9c4c 63629-3359 HUMAN PRESCRIPTION DRUG ARTHROTEC diclofenac sodium and misoprostol TABLET, FILM COATED ORAL 19971224 NDA NDA020607 Bryant Ranch Prepack DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 63629-3362_3087f2b5-44c5-474b-91b7-ef1e57ae90d7 63629-3362 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-3366_169bfb87-147c-4353-a2ce-9e6b7516b489 63629-3366 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20000407 NDA NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-3367_38172acb-386b-4405-8958-4e9202c61dad 63629-3367 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Bryant Ranch Prepack PREGABALIN 50 mg/1 N 20181231 63629-3368_38172acb-386b-4405-8958-4e9202c61dad 63629-3368 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Bryant Ranch Prepack PREGABALIN 75 mg/1 CV N 20181231 63629-3369_5d59c064-cb65-48ca-8e72-535b6498a86e 63629-3369 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Bryant Ranch Prepack PREGABALIN 100 mg/1 N 20181231 63629-3370_2fc29131-501a-4672-8aaa-d37ff3558abf 63629-3370 HUMAN PRESCRIPTION DRUG Depakote ER Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20100607 NDA NDA021168 Bryant Ranch Prepack DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63629-3371_2b1eb1f5-fce8-40ef-930f-3b796f1281c2 63629-3371 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Bryant Ranch Prepack VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-3372_ce96bc99-e5ef-4e96-86d0-784fbe7cbac1 63629-3372 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20080515 NDA NDA021400 Bryant Ranch Prepack VARDENAFIL HYDROCHLORIDE TRIHYDRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 63629-3373_f7efa6c3-f8c1-4bfe-a24e-4818edc45985 63629-3373 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 19970930 NDA NDA020757 Bryant Ranch Prepack IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 63629-3375_37299006-e122-48d9-b688-93e6ae4c22e1 63629-3375 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 20060824 ANDA ANDA077525 Bryant Ranch Prepack GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-3376_a63b4de7-fab8-4674-8f93-af560b9cb763 63629-3376 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 Bryant Ranch Prepack CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-3377_291aba2e-f44d-4823-97f8-0cc13499647b 63629-3377 HUMAN PRESCRIPTION DRUG ATACAND HCT Candesartan cilexetil and Hydrochlorothiazide TABLET ORAL 20000928 NDA NDA021093 Bryant Ranch Prepack CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE 32; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63629-3378_fc4247a0-dc24-49ea-8798-3f3cc20fea03 63629-3378 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 19971001 NDA NDA020639 Bryant Ranch Prepack QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-3379_33c3e856-433b-4bf2-b47c-0244aa14edd3 63629-3379 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20001113 NDA NDA020639 Bryant Ranch Prepack QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-3380_1d454bae-1545-4c55-abd5-7ee56097229b 63629-3380 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20060213 NDA NDA020639 Bryant Ranch Prepack QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-3381_13d04023-9384-4229-bc28-53fc248b827a 63629-3381 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-3383_842e2bc8-1608-4ff6-87cf-5a007182226c 63629-3383 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20031016 NDA NDA021487 Bryant Ranch Prepack MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 63629-3384_476fabdd-0e1a-466c-ad4c-d44e9de88665 63629-3384 HUMAN PRESCRIPTION DRUG Flomax tamsulosin hydrochloride CAPSULE ORAL 19970912 NDA NDA020579 Bryant Ranch Prepack TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 63629-3385_834d5ea8-a23f-4039-a746-42348d708816 63629-3385 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Bryant Ranch Prepack SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-3386_4e27fec8-81ff-42c9-b923-d0e314940e78 63629-3386 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Bryant Ranch Prepack ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-3387_b45241d0-6aa8-44f3-b429-039e4a52d2ad 63629-3387 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Bryant Ranch Prepack ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-3388_37fe9d1c-8a4c-4b48-8008-3fe346007084 63629-3388 HUMAN PRESCRIPTION DRUG PROVIGIL modafinil TABLET ORAL 19981224 NDA NDA020717 Bryant Ranch Prepack MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV E 20171231 63629-3389_c5598a3d-3157-43aa-aa41-cd64597b51d8 63629-3389 HUMAN PRESCRIPTION DRUG Rozerem ramelteon TABLET, FILM COATED ORAL 20050722 NDA NDA021782 Bryant Ranch Prepack RAMELTEON 8 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] E 20171231 63629-3390_aa41c784-2ca3-4c6d-8df2-a38714fbadd8 63629-3390 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Bryant Ranch Prepack OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-3392_6ee88a76-00a8-421c-9c1f-8208bde04a7e 63629-3392 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Bryant Ranch Prepack SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-3393_bb731ae7-08a1-4b50-aae4-0ff6532674bc 63629-3393 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Bryant Ranch Prepack SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 63629-3405_80f5965f-c0e1-4102-8141-490bb5f53c83 63629-3405 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Bryant Ranch Prepack ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] N 20181231 63629-3408_f5ceb3e0-d8ca-4f54-bbcd-e73aad4b5f08 63629-3408 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Bryant Ranch Prepack SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-3449_f2d8f10e-aa40-4678-814d-c95e881d7770 63629-3449 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20050407 ANDA ANDA075310 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 63629-3475_ccb847d3-33e6-4e89-ac8f-d8042b43fdbd 63629-3475 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 Bryant Ranch Prepack METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 63629-3545_f22389d3-ea5a-46bb-8a26-852a7080e56f 63629-3545 HUMAN PRESCRIPTION DRUG PreNatal Vitamins Plus PreNatal Vitamins Plus TABLET ORAL 20110415 UNAPPROVED DRUG OTHER Bryant Ranch Prepack VITAMIN A; CHOLECALCIFEROL; ZINC; THIAMINE; ASCORBIC ACID; CYANOCOBALAMIN; CALCIUM; COPPER; FOLIC ACID; IRON; RIBOFLAVIN; NIACIN; .ALPHA.-TOCOPHEROL ACETATE; PYRIDOXINE 4000; 400; 25; 1.84; 120; 12; 200; 2; 1; 27; 3; 20; 22; 10 [iU]/1; [iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calcium [Chemical/Ingredient],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 63629-3548_7773ba02-33ee-496c-a3a1-3299a5769ad0 63629-3548 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Bryant Ranch Prepack ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 63629-3549_030a9af0-b5cb-43f5-ac4e-d5e37d2bbfdd 63629-3549 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Bryant Ranch Prepack ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 63629-3551_2bef5b11-3f33-402c-a51e-cc38497042d6 63629-3551 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089807 Bryant Ranch Prepack THEOPHYLLINE ANHYDROUS 100 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 63629-3552_7aab61e3-8550-44ea-9bdd-8925c8409b01 63629-3552 HUMAN PRESCRIPTION DRUG Rimantadine Hydrochloride Rimantadine Hydrochloride TABLET, FILM COATED ORAL 20050401 ANDA ANDA076132 Bryant Ranch Prepack RIMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] E 20171231 63629-3561_9fb808ce-f9c7-428c-91cb-96d78f743e2d 63629-3561 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Bryant Ranch Prepack FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 63629-3563_54fae935-fb40-4def-b552-1e34d6437e77 63629-3563 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA076939 Bryant Ranch Prepack PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-3564_4f7c71ff-60c7-4694-85db-972b105fc49a 63629-3564 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 63629-3566_934b0962-270b-4540-9506-ac87e4c98256 63629-3566 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 Bryant Ranch Prepack METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 63629-3583_c195fb1e-6c9a-4471-9b95-5aa70a9bb5d1 63629-3583 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Bryant Ranch Prepack LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-3587_46420ed0-86f7-4f1b-bcf2-5927b8d66413 63629-3587 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070178 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 63629-3597_ef862358-7fe0-44a1-be67-729b4a3f5259 63629-3597 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085971 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-3610_2eee0905-67c1-4914-98de-0dba44341bf1 63629-3610 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 19950801 NDA NDA020487 Bryant Ranch Prepack VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 63629-3632_336edf41-e455-4672-a319-5ea304d18f06 63629-3632 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 19961125 NDA NDA020690 Bryant Ranch Prepack DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 63629-3633_1dc9946a-0488-47cc-a137-b4e790d21b00 63629-3633 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19970623 NDA NDA020592 Bryant Ranch Prepack OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20191231 63629-3636_a95f60c6-a833-466d-a6b9-143ea8a26f19 63629-3636 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 Bryant Ranch Prepack METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 63629-3638_f8244be8-431a-41ac-85b7-38ad35b180ba 63629-3638 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070801 ANDA ANDA078314 Bryant Ranch Prepack NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-3639_bdd3dbf9-5245-4cb2-afb6-e67c79345e49 63629-3639 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20050915 ANDA ANDA077314 Bryant Ranch Prepack NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63629-3640_015c3683-9e1c-49cc-b8a9-a3165e6ee906 63629-3640 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Bryant Ranch Prepack CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63629-3641_202c286d-11c1-43ca-9603-5a69184f4bf2 63629-3641 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20150309 ANDA ANDA075126 Bryant Ranch Prepack ETODOLAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-3642_d30a0ce3-e747-448a-98ab-6b5804003061 63629-3642 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073516 Bryant Ranch Prepack KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-3643_7afcb90b-b4a8-4edd-a715-17e9964bc6ee 63629-3643 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Bryant Ranch Prepack OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63629-3645_944d6528-4841-40f8-bdf0-deeb55304b02 63629-3645 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880524 ANDA ANDA072100 Bryant Ranch Prepack DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-3646_de5be906-6888-43d6-aea0-169ac24ce18d 63629-3646 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Bryant Ranch Prepack CLORAZEPATE DIPOTASSIUM 3.75 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-3649_efdd1446-9970-4020-9401-05c2d9b590e4 63629-3649 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 63629-3668_d12bc5b7-6d74-4744-bdf5-0d507f166071 63629-3668 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Bryant Ranch Prepack CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 63629-3669_7380d9b8-9623-49b7-876c-b46767419218 63629-3669 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20090323 ANDA ANDA078332 Bryant Ranch Prepack CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 63629-3678_44fb1794-6e03-4313-b33b-72fc9619f9d0 63629-3678 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070524 ANDA ANDA076719 Bryant Ranch Prepack AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63629-3685_181d0b2d-69b2-4b47-a5f0-e410ffc00a9a 63629-3685 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20030828 ANDA ANDA076570 Bryant Ranch Prepack TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 63629-3701_a8054858-c322-4f42-ae25-127247706b57 63629-3701 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 19980220 NDA NDA020830 Bryant Ranch Prepack MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 63629-3707_0c17d356-ebc7-4476-a844-b1fffae3543e 63629-3707 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080936 Bryant Ranch Prepack ISONIAZID 100 mg/1 Antimycobacterial [EPC] E 20171231 63629-3708_9c17ec04-0a0d-4ce9-a70f-9730ffd49ec8 63629-3708 HUMAN OTC DRUG Cetirizine Cetirizine Hydrochloride TABLET ORAL 20080116 ANDA ANDA078336 Bryant Ranch Prepack CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 63629-3711_d2a74d85-9cde-4bcb-8903-2dc5ee551be6 63629-3711 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086067 Bryant Ranch Prepack ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 63629-3730_33c69894-29a9-44fd-9833-ba8852a29e23 63629-3730 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020211 ANDA ANDA040422 Bryant Ranch Prepack DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 63629-3731_6282f009-b3a8-4fcd-9410-7a0dae13de1f 63629-3731 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Suflate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20020211 ANDA ANDA040422 Bryant Ranch Prepack DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 63629-3738_30da1180-803c-4cc6-bd4b-7a49cc02443f 63629-3738 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 Bryant Ranch Prepack ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 63629-3739_0b01f3b3-0ab3-433c-9f97-0411c891d5f9 63629-3739 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-3742_c71547cc-7e6e-4b06-a189-3d3bd98f75e8 63629-3742 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 Bryant Ranch Prepack DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63629-3748_da532c7f-affb-43be-9a96-491dbb394d0c 63629-3748 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 Bryant Ranch Prepack ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 63629-3750_71049b9a-da83-477d-a877-b427b52d3027 63629-3750 HUMAN PRESCRIPTION DRUG Afeditab CR Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021101 ANDA ANDA075659 Bryant Ranch Prepack NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63629-3755_2ca7ce7c-5fb4-41b7-b82c-52f4be6d4613 63629-3755 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Bryant Ranch Prepack ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20191231 63629-3757_401d201f-c53d-441f-9614-e9218e34597f 63629-3757 HUMAN OTC DRUG Calcium carbonate Calcium carbonate TABLET ORAL 19990412 OTC MONOGRAPH FINAL part331 Bryant Ranch Prepack CALCIUM CARBONATE 648 mg/1 E 20171231 63629-3760_14c4c4ff-913b-4d12-a617-450cf58ca0bb 63629-3760 HUMAN PRESCRIPTION DRUG REQUIP ropinirole TABLET, FILM COATED ORAL 19971001 NDA NDA020658 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 63629-3762_45fa1a0a-5ee3-4cc2-b2cc-d7c12bed54a2 63629-3762 HUMAN PRESCRIPTION DRUG Budeprion Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080530 ANDA ANDA077284 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 63629-3765_ce103e45-81fc-453c-98a4-bb8ab39c98b2 63629-3765 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Bryant Ranch Prepack MORPHINE SULFATE 120 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-3766_46391396-3a08-4be2-aa78-0c43510cfa29 63629-3766 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Bryant Ranch Prepack MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-3767_f5ae7ebd-de28-439d-bf24-c0b313167cbc 63629-3767 HUMAN PRESCRIPTION DRUG AVINZA MORPHINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20020320 NDA NDA021260 Bryant Ranch Prepack MORPHINE SULFATE 90 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-3768_f6405586-3f10-422a-893a-88fdcab72664 63629-3768 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 19960213 ANDA ANDA040422 Bryant Ranch Prepack DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 63629-3769_1d0c5bc5-ab57-485b-b19b-e4fe47d97bbe 63629-3769 HUMAN PRESCRIPTION DRUG Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate TABLET ORAL 19960213 ANDA ANDA040422 Bryant Ranch Prepack DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 63629-3770_719aa19b-24b8-9a20-a00e-f6335ecd4b53 63629-3770 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20090401 ANDA ANDA040550 Bryant Ranch Prepack ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500; 7.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-3771_23aaa0fb-2334-4032-8793-aaed79965909 63629-3771 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 Bryant Ranch Prepack METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-3772_c8127f3a-8b44-464b-a051-16baea503fa8 63629-3772 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-3773_f8b7e42f-665e-4aba-a97b-4e847dfdacb6 63629-3773 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 19990730 ANDA ANDA040341 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 500 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-3774_94a64cc4-59ee-456b-a5dd-821d57e3d023 63629-3774 HUMAN PRESCRIPTION DRUG OxyContin oxycodone hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100808 NDA NDA022272 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-3776_6a486e80-1f8b-4bb8-962f-2bf70ad48a0c 63629-3776 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 19990730 ANDA ANDA040341 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 650 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-3783_fa3d7d29-4851-427e-9444-11a02216cad5 63629-3783 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 19950401 UNAPPROVED DRUG OTHER Bryant Ranch Prepack SALSALATE 750 mg/1 E 20171231 63629-3786_f64a6e8f-d32b-48b8-a665-ba2435c61468 63629-3786 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Bryant Ranch Prepack ESZOPICLONE 2 mg/1 CIV E 20171231 63629-3788_62c7f7a2-72e7-4cde-9336-33665d7183da 63629-3788 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20090519 ANDA ANDA040517 Bryant Ranch Prepack METHADONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-3789_8f8098ab-fc5b-4487-b8af-ec62403c664f 63629-3789 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022207 Bryant Ranch Prepack MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-3791_e7ca6d2c-2549-48af-9d10-778ca232d546 63629-3791 HUMAN PRESCRIPTION DRUG Methergine methylergonovine maleate TABLET, COATED ORAL 19461119 NDA NDA006035 Bryant Ranch Prepack METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] E 20171231 63629-3795_29d969be-20ee-4b90-b4f4-339351b45ca4 63629-3795 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980729 ANDA ANDA075227 Bryant Ranch Prepack NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-3798_54351185-cdbd-4bd7-87dd-d58f8d8b4b18 63629-3798 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE Hydromorphone Hydrochloride TABLET ORAL 20091123 NDA AUTHORIZED GENERIC NDA019892 Bryant Ranch Prepack HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-3803_e4355d25-edd6-4289-b54e-c3b222f13a1a 63629-3803 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20101215 NDA AUTHORIZED GENERIC NDA200534 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-3807_f7deb6bf-c840-4542-a927-bb144f3069f9 63629-3807 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ROPINIROLE TABLET, FILM COATED ORAL 20140929 ANDA ANDA090429 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 63629-3816_5c0405d8-b3e6-4cc1-83b5-ae9fbcf50bcd 63629-3816 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 Bryant Ranch Prepack OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63629-3858_1012b2db-17ff-4f67-abe9-bc48c5c2dc06 63629-3858 HUMAN PRESCRIPTION DRUG Clorazepate dipotassium Clorazepate dipotassium TABLET ORAL 20050114 ANDA ANDA076911 Bryant Ranch Prepack CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-3859_d42b3b3a-fe63-40d9-acc1-90a515a03969 63629-3859 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20000427 ANDA ANDA075731 Bryant Ranch Prepack CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-3868_01ffbc56-3e5f-4b71-b511-92f03bf0a60b 63629-3868 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 Bryant Ranch Prepack CIPROFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 63629-3870_8f05a130-4eee-4acf-9cf0-03fc9d1b439f 63629-3870 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 Bryant Ranch Prepack DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 63629-3906_feb24692-8b43-4789-b895-0a78bee50338 63629-3906 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080501 NDA NDA020859 Bryant Ranch Prepack ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 63629-3910_448b3e50-18ea-438d-95f3-fa7015458a26 63629-3910 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 Bryant Ranch Prepack METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63629-3941_b43ab2c6-14cb-4a0d-ab12-d3ff77ec3c3d 63629-3941 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, EXTENDED RELEASE ORAL 20040302 ANDA ANDA075910 Bryant Ranch Prepack DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-3953_66cca5ba-3228-49f0-934e-715c9fe4e784 63629-3953 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN Oxycodone hydrochloride and Acetaminophen TABLET ORAL 20090806 ANDA ANDA090177 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-3961_946b00d2-ffe8-4f2e-a7b4-f067fd6a7d6b 63629-3961 HUMAN OTC DRUG Rugby Nasal Decongestant Pseudoephedrine Hydrochloride LIQUID ORAL 19990726 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5mL E 20171231 63629-3973_90a1bdde-3310-4239-b28f-8521aec25061 63629-3973 HUMAN PRESCRIPTION DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20060412 ANDA ANDA076502 Bryant Ranch Prepack FEXOFENADINE HYDROCHLORIDE 60 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 63629-3975_8cc26f99-6c08-4ca9-abb3-e5a64723016a 63629-3975 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20101021 ANDA ANDA076412 Bryant Ranch Prepack MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-3976_7b7c4dcd-8805-4bdb-a75d-e52fef96e407 63629-3976 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 19870501 ANDA ANDA074862 Bryant Ranch Prepack MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-3979_6302daf7-8b23-4633-ab2b-f7b7dc9f02b5 63629-3979 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate Extended Release TABLET ORAL 20100318 ANDA ANDA076412 bryant ranch prepack MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-3981_3b38072b-ee26-496a-85a6-b77ba104e3dc 63629-3981 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 Bryant Ranch Prepack LEVOFLOXACIN 500 mg/1 N 20181231 63629-3982_291423bd-d8d3-4438-935c-f131dc57523a 63629-3982 HUMAN PRESCRIPTION DRUG VALTREX valacyclovir hydrochloride TABLET, FILM COATED ORAL 20020812 NDA NDA020487 Bryant Ranch Prepack VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 63629-3990_23137b83-c2a1-4cd4-83a4-c859a5305ce3 63629-3990 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880620 ANDA ANDA072103 Bryant Ranch Prepack DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63629-3994_2b7fc7c2-ca62-4eb6-96eb-3f59561f9ea0 63629-3994 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20110101 ANDA ANDA079162 Bryant Ranch Prepack TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63629-3995_6039fd1b-5061-4071-aba3-2da49374f26c 63629-3995 HUMAN PRESCRIPTION DRUG Topiramate topiramate TABLET ORAL 20090327 ANDA ANDA079162 Bryant Ranch Prepack TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 63629-3998_faebe298-576b-4bf9-a9f2-c87bceba0f8b 63629-3998 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Glyburide and Metformin TABLET, FILM COATED ORAL 20070614 ANDA ANDA076345 Bryant Ranch Prepack GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 63629-4000_2d09e345-10b4-7d59-ee6c-4ff91e2e505f 63629-4000 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090601 ANDA ANDA090659 bryant ranch prepack OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4008_97635cc5-cd1c-49f2-870f-9be59c6d4101 63629-4008 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20080722 OTC MONOGRAPH FINAL part336 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 25 mg/1 E 20171231 63629-4010_9dacc9a9-1222-42ef-b405-aacf856df621 63629-4010 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 19590806 NDA NDA011722 Bryant Ranch Prepack DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 63629-4014_c76dbad9-4c01-4f70-b0dd-b3bf6dd6867e 63629-4014 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Bryant Ranch Prepack ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63629-4017_13eb35ba-57a2-4ad2-b8c5-ab0b4647bb49 63629-4017 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Bryant Ranch Prepack WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 63629-4018_b09812fd-2597-488b-8a82-ea1b927cc3d9 63629-4018 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19900930 ANDA ANDA070541 Bryant Ranch Prepack CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 63629-4023_ec637859-4d69-47c1-a016-faaa34fc89a8 63629-4023 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Bryant Ranch Prepack ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63629-4026_f23998a2-de80-4ffb-9241-11c609a14632 63629-4026 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20000101 UNAPPROVED DRUG OTHER Bryant Ranch Prepack PHENOBARBITAL 15 mg/1 CIV E 20171231 63629-4027_49a8ef29-fc03-48bc-bb65-48d9ff8b706d 63629-4027 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760701 ANDA ANDA084769 Bryant Ranch Prepack CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63629-4028_897164c4-714d-4b8a-8b6a-9ffc7f3627a0 63629-4028 HUMAN PRESCRIPTION DRUG Suboxone buprenorphine and naloxone FILM, SOLUBLE SUBLINGUAL 20100913 NDA NDA022410 Bryant Ranch Prepack BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII E 20171231 63629-4034_614f49fb-4133-4949-81fb-15ea64d737dd 63629-4034 HUMAN PRESCRIPTION DRUG suboxone buprenorphine hydrochloride and naloxone hydrochloride TABLET ORAL 20090723 NDA NDA020733 Bryant Ranch Prepack BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII E 20171231 63629-4037_d5ecb47f-3211-4008-b2e9-851c06fd4fdf 63629-4037 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20110308 ANDA ANDA075536 Bryant Ranch Prepack DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63629-4042_3d060013-df6c-4c51-9281-895cfa1f1e71 63629-4042 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 19970528 ANDA ANDA064150 Bryant Ranch Prepack RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 63629-4053_32aa1074-1b00-5d7c-b1b0-3c0cc9720fd3 63629-4053 HUMAN PRESCRIPTION DRUG Childrens Silapap Acetaminophen LIQUID ORAL 19940905 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ACETAMINOPHEN 160 mg/5mL E 20171231 63629-4057_b6366b11-fbb5-4167-b663-4e5f1447b0da 63629-4057 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000811 ANDA ANDA075665 Bryant Ranch Prepack ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-4060_2eb762f3-3ce5-4392-8fb7-7d82463373d6 63629-4060 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Bryant Ranch Prepack CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 63629-4061_ff45808a-31a6-4880-bec7-4a799a28f097 63629-4061 HUMAN PRESCRIPTION DRUG ALPRAZOLAM EXTENDED-RELEASE ALPRAZOLAM TABLET, EXTENDED RELEASE ORAL 20070328 ANDA ANDA077996 Bryant Ranch Prepack ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-4068_d75d0d48-2e49-41cd-8690-1b33ffb85ad3 63629-4068 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN TABLET ORAL 20090904 ANDA ANDA040535 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4070_c0af8166-da89-47ff-a15c-9d1c8caec03f 63629-4070 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Bryant Ranch Prepack CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 63629-4071_6e6cf9e4-16bd-40ac-91ea-c03e51d2cc0e 63629-4071 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031101 ANDA ANDA076467 Bryant Ranch Prepack GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 63629-4072_8b4d4bd5-02f5-4a14-b6b2-131485514bed 63629-4072 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Bryant Ranch Prepack BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63629-4073_cd9da0ba-aab5-4b1e-b344-beb2fc810156 63629-4073 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100420 ANDA ANDA074330 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63629-4075_e756bbe1-9c0e-428c-b7f7-ba72039e5cca 63629-4075 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol Fumarate and Hydrochlorothiazide TABLET, COATED ORAL 20000925 ANDA ANDA075579 Bryant Ranch Prepack BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 10; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-4089_3d13bbbc-ace1-4561-8d1d-333b60af6cce 63629-4089 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, EXTENDED RELEASE ORAL 20091005 ANDA ANDA075128 bryant ranch prepack NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63629-4092_50924708-d935-4e10-825c-b6d340c81efa 63629-4092 HUMAN PRESCRIPTION DRUG Buprenorphine hydrochloride Buprenorphine hydrochloride TABLET ORAL 20091009 ANDA ANDA020732 bryant ranch prepack BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII E 20171231 63629-4093_6f051633-ebf9-499b-9ea4-a79ab5fc3468 63629-4093 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Bryant Ranch Prepack ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63629-4094_33042c42-ad7b-4f82-94f9-df047323e1fd 63629-4094 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 Bryant Ranch Prepack SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 63629-4096_0b311e9e-302d-4f18-b4eb-4a6a904357d8 63629-4096 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Bryant Ranch Prepack METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 63629-4099_c9a663f9-708e-4b80-865d-5f3a32864f84 63629-4099 HUMAN PRESCRIPTION DRUG butalbital, acetominophen and caffeine butalbital, acetominophen and caffeine TABLET ORAL 20090427 ANDA ANDA040883 Bryant Ranch Prepack BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 500; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 63629-4108_57895df4-bf6f-44f2-9b85-13131d5bc9ab 63629-4108 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19980811 ANDA ANDA075219 Bryant Ranch Prepack DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-4112_75eaf6c9-b57b-4880-ab58-372c2fa3ac27 63629-4112 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 19910731 ANDA ANDA073191 Bryant Ranch Prepack TRIAMTERENE; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63629-4121_e819f13c-b201-4698-bf1b-4a1e5136263c 63629-4121 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040742 Bryant Ranch Prepack BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 63629-4123_04c1d597-e0c5-4c78-901b-7eec39a54a7b 63629-4123 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Bryant Ranch Prepack CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63629-4125_6b6fef9a-a925-4b4f-ab5f-9f2f860959f1 63629-4125 HUMAN PRESCRIPTION DRUG Fluvoxamine Maleate Fluvoxamine Maleate TABLET, FILM COATED ORAL 20100312 ANDA ANDA075897 Bryant Ranch Prepack FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-4126_07e005da-6975-44a9-bd6b-22ec0ffbe92a 63629-4126 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Bryant Ranch Prepack BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 63629-4127_c35febd2-5bb3-4738-beb9-8740152b833a 63629-4127 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750519 ANDA ANDA084610 Bryant Ranch Prepack DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63629-4129_621da8df-c684-45ff-a1ae-4bcb5769e8d9 63629-4129 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19750603 ANDA ANDA084613 Bryant Ranch Prepack DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63629-4137_a30bafd4-916a-4254-8e45-012fa8047161 63629-4137 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Bryant Ranch Prepack LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-4139_c09c2424-b088-4211-bd2e-67a10602fd92 63629-4139 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride TABLET ORAL 20100201 ANDA ANDA040845 bryant ranch prepack BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII E 20171231 63629-4141_649a67eb-0e31-4738-9409-451050921abe 63629-4141 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19980324 ANDA ANDA075124 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63629-4144_bd79de3b-b605-4ef9-b692-4fcb53b55dc8 63629-4144 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20050919 ANDA ANDA077267 Bryant Ranch Prepack ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 63629-4145_34cec837-c90e-4775-a214-6eb7045e3f78 63629-4145 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20080107 NDA NDA021368 Bryant Ranch Prepack TADALAFIL 2.5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 63629-4146_2d98fffd-516c-481d-8736-6aea6add2dc3 63629-4146 HUMAN PRESCRIPTION DRUG NAPRELAN naproxen sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960105 NDA NDA020353 Bryant Ranch Prepack NAPROXEN SODIUM 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-4148_7c7ccdc6-3cf6-4f28-9c43-b37dfa1ffa71 63629-4148 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-4151_d85027cd-f6bc-419c-9190-7a263ce441fb 63629-4151 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091111 NDA AUTHORIZED GENERIC NDA020406 Bryant Ranch Prepack LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 63629-4153_cbb391b5-f1fb-4dd9-a17d-a32456c1c513 63629-4153 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20100304 ANDA ANDA076636 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4155_4f92eca1-edf5-4b22-a66e-69c549dda71f 63629-4155 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride CAPSULE ORAL 20100308 ANDA ANDA077712 bryant ranch prepack OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4159_b571ae18-07a9-408f-93aa-52c0560d22a4 63629-4159 HUMAN PRESCRIPTION DRUG AVAPRO IRBESARTAN TABLET ORAL 19970930 NDA NDA020757 Bryant Ranch Prepack IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 63629-4169_baa7d824-f7f7-4107-8fb2-8c29c15d4098 63629-4169 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Bryant Ranch Prepack LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 63629-4170_134665a7-7b92-47b4-b68c-3a959b48d8c0 63629-4170 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20030301 ANDA ANDA076243 Bryant Ranch Prepack LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 63629-4171_742141d8-367a-4dbd-a761-b3c888afc1f5 63629-4171 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Bryant Ranch Prepack LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 63629-4173_e012662b-f062-48e0-b84e-be1187e2040a 63629-4173 HUMAN PRESCRIPTION DRUG OPANA Oxymorphone Hydrochloride TABLET ORAL 20060626 NDA NDA021611 Bryant Ranch Prepack OXYMORPHONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-4174_b0d683e0-ee2e-4a82-8ae5-fec301c8167b 63629-4174 HUMAN PRESCRIPTION DRUG Opana ER OXYMORPHONE HYDROCHLORIDE TABLET ORAL 20101231 NDA NDA021610 Bryant Ranch Prepack OXYMORPHONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4175_73595f10-6a95-48b7-b215-a0b4af54c897 63629-4175 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022207 Bryant Ranch Prepack MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-4177_b8bdd68c-ac5d-4244-b9d9-1818cafa9674 63629-4177 HUMAN PRESCRIPTION DRUG OPANA ER Oxymorphone Hydrochloride TABLET, EXTENDED RELEASE ORAL 20060630 NDA NDA021610 Bryant Ranch Prepack OXYMORPHONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4179_c2911a41-c214-41b7-94b1-1cd02fb23daa 63629-4179 HUMAN PRESCRIPTION DRUG NUCYNTA tapentadol hydrochloride TABLET, FILM COATED ORAL 20090601 NDA NDA022304 Bryant Ranch Prepack TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 63629-4181_d1ecc100-501d-4400-820c-89c0e7f9c0b4 63629-4181 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021446 Bryant Ranch Prepack PREGABALIN 150 mg/1 N 20181231 63629-4183_35203bb0-ef19-4f23-be1f-b4c8eb36d323 63629-4183 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Bryant Ranch Prepack LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 63629-4184_dbc5254f-4f73-49ee-a8af-b3280963a05a 63629-4184 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20090302 ANDA ANDA077712 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-4185_032220f5-0324-e3e9-1289-aa3b7d1bf09f 63629-4185 HUMAN PRESCRIPTION DRUG Divalproex Sodium Delayed-Release Divalproex Sodium TABLET, FILM COATED ORAL 20091130 ANDA ANDA090210 Bryant Ranch Prepack DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63629-4191_995e9317-3019-411d-a2d6-0984653ed4f9 63629-4191 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Bryant Ranch Prepack MORPHINE SULFATE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-4203_aa97fa0e-0afa-401c-8364-f345aad1a055 63629-4203 HUMAN PRESCRIPTION DRUG Good Sense Heartburn Relief Cimetidine TABLET ORAL 20021230 ANDA ANDA075285 Bryant Ranch Prepack CIMETIDINE 200 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 63629-4205_5510d36c-d81b-43e3-b75e-fb4f85555228 63629-4205 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 Bryant Ranch Prepack METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 63629-4238_e01c0d42-567f-4e0b-a383-c2f73ee2e42d 63629-4238 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Bryant Ranch Prepack LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63629-4241_7044b9e8-9291-44eb-af00-0504f039bb93 63629-4241 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Bryant Ranch Prepack METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 63629-4244_3785e70e-ccc0-3794-adae-d09b6ed66426 63629-4244 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-4245_2b8d7ff8-709c-4df8-82ab-dd627dac3f69 63629-4245 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-4251_95087193-78b4-4aa0-a115-f53f8ccb45dd 63629-4251 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 63629-4276_320c594c-99eb-454b-b3a7-fc4e5f390cfa 63629-4276 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20101103 ANDA ANDA074132 Bryant Ranch Prepack NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63629-4278_541885ec-6925-4814-820c-7e3527e823ec 63629-4278 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Bryant Ranch Prepack DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63629-4279_244b2104-c81e-4758-911f-3c48ed8eae58 63629-4279 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 19930901 ANDA ANDA074260 Bryant Ranch Prepack CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 63629-4284_a5b7459f-8634-46e5-985b-f7d2bc04d848 63629-4284 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091123 NDA AUTHORIZED GENERIC NDA019892 Bryant Ranch Prepack HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-4302_9233352c-b04b-4cae-93fe-ce273deee859 63629-4302 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040715 Bryant Ranch Prepack BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 63629-4304_f1aaad63-32f6-483d-850c-631c071f1186 63629-4304 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-4305_af062b16-1dea-423d-9afe-2693f0e0d5fe 63629-4305 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Bryant Ranch Prepack CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63629-4306_b0198684-051a-4f63-8236-e44906adf97f 63629-4306 HUMAN PRESCRIPTION DRUG ONDANSETRON ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 Bryant Ranch Prepack ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63629-4311_6da3d52a-58d0-419a-ab33-e42052c0379e 63629-4311 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-4331_04d44870-bf1b-4233-89d2-2b01bf39b8ac 63629-4331 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20000413 ANDA ANDA040350 Bryant Ranch Prepack METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 63629-4335_7c1e835e-80a6-4743-afd5-3dddc0679133 63629-4335 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 63629-4337_57c103e0-d723-0031-b263-f02d7b8fc35b 63629-4337 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63629-4338_d00601cb-53b2-4813-8289-640c71454bc6 63629-4338 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 63629-4346_9508d205-95a8-4382-9f33-b6f9266b16e1 63629-4346 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078225 Bryant Ranch Prepack TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63629-4353_9a4567b7-65d9-4017-9075-4378e4b8de4c 63629-4353 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63629-4358_7afcb90b-b4a8-4edd-a715-17e9964bc6ee 63629-4358 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Bryant Ranch Prepack OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63629-4367_2c220e74-6f87-4837-91c8-1d16cffe6838 63629-4367 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET, FILM COATED ORAL 20100225 ANDA ANDA075504 Bryant Ranch Prepack QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63629-4368_65dd3338-1602-4ab6-bd47-ef6c744c2b2a 63629-4368 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 19960401 UNAPPROVED DRUG OTHER Bryant Ranch Prepack THYROID, PORCINE 60 mg/1 N 20181231 63629-4372_f759dc50-13a4-417b-8f29-17f61130a197 63629-4372 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-4383_cb4d9e6c-02d8-4816-8d50-8cce6cab65f0 63629-4383 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Bryant Ranch Prepack LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63629-4385_4bd5ec5e-1fbc-413e-bf03-66000b3eb778 63629-4385 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120815 ANDA ANDA040876 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 63629-4387_eb400030-0ce6-33a8-6400-42681441c940 63629-4387 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 Bryant Ranch Prepack METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-4389_20bf0426-4b37-4081-a1e4-0383aaea372e 63629-4389 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Bryant Ranch Prepack CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 63629-4390_d454c75f-0e59-a40f-9ad9-d7fab0da0390 63629-4390 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20081223 ANDA ANDA072750 Bryant Ranch Prepack METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 63629-4394_e639d7a6-ee49-4ba2-b7de-016ca59d7695 63629-4394 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 Bryant Ranch Prepack TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 63629-4399_aaac47d1-8065-45d9-82c7-50797dabc934 63629-4399 HUMAN PRESCRIPTION DRUG Cetirizine HCl and Pseudoephedrine HCl ER Cetirizine HCl and Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080305 ANDA ANDA077991 Bryant Ranch Prepack CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20191231 63629-4407_d96a708f-6c3a-40db-9731-6785e0a08cef 63629-4407 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040778 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-4413_9116209f-df47-45cd-9147-acd2e3eb0b5d 63629-4413 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20110307 ANDA ANDA070929 Bryant Ranch Prepack TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 63629-4417_cfc96d11-cefc-44af-835e-5de358c3c907 63629-4417 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Bryant Ranch Prepack WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 63629-4422_2a688115-8e10-4313-8598-821b523af21d 63629-4422 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Bryant Ranch Prepack METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63629-4436_1bf47e4a-baa6-422f-a185-4357d8a33e80 63629-4436 HUMAN OTC DRUG Fiber Lax Calcium Polycarbophil TABLET, FILM COATED ORAL 20100901 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack CALCIUM POLYCARBOPHIL 625 mg/1 E 20171231 63629-4442_fcc6e15d-aa4e-44b0-8af0-b1a5bd13b5eb 63629-4442 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Bryant Ranch Prepack DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63629-4448_5ec79934-0304-4e3d-a0ef-f12cb0b72c6b 63629-4448 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20051018 ANDA ANDA065144 Bryant Ranch Prepack CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63629-4458_ece7ce7e-faf0-49e0-8129-66be287e5437 63629-4458 HUMAN OTC DRUG MUCOSA DM GUAIFENESIN DEXTROMETHORPHAN TABLET ORAL 20120417 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 E 20171231 63629-4462_da76aa79-61b6-43d2-9422-b46dd6badc01 63629-4462 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 Bryant Ranch Prepack CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 63629-4468_638349e1-2e32-4372-9876-3e13e2fc0e13 63629-4468 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA077135 Bryant Ranch Prepack VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63629-4470_e535c57b-b453-4009-b0f6-20407c1292ee 63629-4470 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-4475_ffbae910-272e-42a8-9703-2c3768146699 63629-4475 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20090127 ANDA ANDA079234 Bryant Ranch Prepack TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 63629-4483_8f987a0b-729c-4ad7-bf4c-4288cc0254ed 63629-4483 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Bryant Ranch Prepack MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-4484_edaeca7a-0599-44dc-9c2a-217fe2841eac 63629-4484 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Bryant Ranch Prepack MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4492_6d6eead5-3d00-43ec-9736-6bb4d628ea95 63629-4492 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride levocetirizine dihydrochloride TABLET ORAL 20110225 ANDA ANDA090385 Bryant Ranch Prepack LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 63629-4501_a4e8deb5-acd8-4c30-beab-12360200bca3 63629-4501 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 63629-4504_ef76e339-5162-4b9c-b1e2-246d6f3b46f0 63629-4504 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Bryant Ranch Prepack RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-4505_be0fe24f-621c-4187-823f-bcb587c2ef73 63629-4505 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Bryant Ranch Prepack RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-4506_7909dcf7-da31-4c99-bac8-f93a702cb93c 63629-4506 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20081229 ANDA ANDA078707 Bryant Ranch Prepack RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20191231 63629-4514_88ddfc7a-46c4-4171-b74c-f7f0b83e314a 63629-4514 HUMAN PRESCRIPTION DRUG morphine sulfate extended release morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074769 Bryant Ranch Prepack MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4515_736872b0-855f-48c9-a5eb-dddc30eb32b3 63629-4515 HUMAN PRESCRIPTION DRUG morphine sulfate extended release morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 Bryant Ranch Prepack MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4519_4b2ba734-d705-44a2-add7-afe6e344248d 63629-4519 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090790 Bryant Ranch Prepack LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-4521_ae724b62-f78f-476a-a7ef-b7f7b3200b12 63629-4521 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride hydromorphone hydrochloride TABLET ORAL 20090729 ANDA ANDA074597 Bryant Ranch Prepack HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4525_0351091a-2a66-405b-b4e9-044b7f75eebf 63629-4525 HUMAN PRESCRIPTION DRUG TERAZOSIN HYDROCHLORIDE Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Bryant Ranch Prepack TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63629-4526_0522c550-6f5a-4d9b-b8c9-c8ded7b2beb7 63629-4526 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Bryant Ranch Prepack LEVOFLOXACIN 500 mg/1 E 20171231 63629-4534_75cd9853-af3a-49e2-8202-aa3073f70322 63629-4534 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-4543_e00b1c55-cbef-47db-a863-c4fa4e3b8066 63629-4543 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Bryant Ranch Prepack WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 63629-4546_faedb976-f372-431e-affa-93748bdd9ff2 63629-4546 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20020301 UNAPPROVED DRUG OTHER Bryant Ranch Prepack PHENOBARBITAL 16.2 mg/1 CIV E 20171231 63629-4549_e3004ed1-b5a7-4fd7-adbb-efc86feeddc8 63629-4549 HUMAN PRESCRIPTION DRUG Meperidine Hydrochloride Meperidine Hydrochloride TABLET ORAL 19981217 ANDA ANDA040191 Bryant Ranch Prepack MEPERIDINE HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-4556_1777cd61-e83f-487b-a3ec-939fe4adef4b 63629-4556 HUMAN PRESCRIPTION DRUG NP Thyroid 30 LEVOTHYROXINE, LIOTHYRONINE TABLET ORAL 20101111 UNAPPROVED DRUG OTHER Bryant Ranch Prepack LEVOTHYROXINE; LIOTHYRONINE 19; 4.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 63629-4562_469767c4-e5c7-4f83-9876-0e0db049bf07 63629-4562 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030314 ANDA ANDA084283 Bryant Ranch Prepack PREDNISONE 50 mg/1 N 20191231 63629-4565_ce8e1df2-f8e1-44c4-868f-3dfd7f7b1176 63629-4565 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060317 ANDA ANDA077634 Bryant Ranch Prepack ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63629-4571_59828580-db0c-4973-ad49-0a3e5ff9a658 63629-4571 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Bryant Ranch Prepack FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4588_88054972-5e46-4a71-8065-293f2fae7112 63629-4588 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Bryant Ranch Prepack PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-4593_e3d34142-b46e-42a4-af72-851cbe356216 63629-4593 HUMAN PRESCRIPTION DRUG FAMOTIDINE Famotidine TABLET ORAL 20100218 ANDA ANDA075512 Bryant Ranch Prepack FAMOTIDINE 10 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 63629-4594_1b53359c-3ec2-413e-9526-303b4e8ffd07 63629-4594 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20151210 ANDA ANDA078279 Bryant Ranch Prepack ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63629-4597_4af584dd-4c5c-40f1-aefb-14d6eeef603d 63629-4597 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Bryant Ranch Prepack ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 63629-4601_8a6902a9-c846-4d32-8108-200a302da320 63629-4601 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Bryant Ranch Prepack TADALAFIL 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 63629-4605_ee2e657f-fd08-4803-bbb1-da32a02c8848 63629-4605 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Bryant Ranch Prepack METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 63629-4606_afe9c029-cdaa-4e6c-83e4-3b63b2285235 63629-4606 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 63629-4610_aad51968-d672-4ea6-bc42-bdbbe8319e3c 63629-4610 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 63629-4615_4c7ed1cf-75c6-461d-8bda-17955dadb43c 63629-4615 HUMAN PRESCRIPTION DRUG PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100913 NDA NDA020936 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63629-4638_3df56c18-ae14-4142-a42f-3c11ad79a333 63629-4638 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 Bryant Ranch Prepack FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 63629-4642_50347a48-e7de-41e4-8693-fb3faf0395df 63629-4642 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076361 Bryant Ranch Prepack LEVOFLOXACIN 750 mg/1 E 20171231 63629-4663_9dfc687b-d673-48a1-be1c-bf47657cbcfc 63629-4663 HUMAN PRESCRIPTION DRUG Good Sense Acid Reducer Ranitidine TABLET ORAL 20090521 ANDA ANDA076760 Bryant Ranch Prepack RANITIDINE HYDROCHLORIDE 75 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 63629-4664_5268b5ff-4092-4806-9957-5031002a8fba 63629-4664 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 Bryant Ranch Prepack CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 63629-4669_da904f80-2863-4bb8-a68e-19afea1b0b0c 63629-4669 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19900930 ANDA ANDA083116 Bryant Ranch Prepack CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-4675_cf5ec5bc-5746-4a87-bd0e-00a8391a1180 63629-4675 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Bryant Ranch Prepack LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63629-4676_0cd53f16-0a6a-417e-9163-a0841a2bafc5 63629-4676 HUMAN PRESCRIPTION DRUG fluvoxamine maleate fluvoxamine maleate TABLET, FILM COATED ORAL 20001129 ANDA ANDA075888 Bryant Ranch Prepack FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63629-4685_7248e270-d34d-4e77-a23c-bd802cd4b4cd 63629-4685 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110222 NDA AUTHORIZED GENERIC NDA018279 Bryant Ranch Prepack POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 63629-4688_d22b5142-0cd1-4802-8fa4-c7ead9ee49eb 63629-4688 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Bryant Ranch Prepack ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-4689_503f3d4d-60ac-424f-8319-1b1966cba81e 63629-4689 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-4694_d99f379d-a686-4a50-9dca-18de3b26f25c 63629-4694 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Bryant Ranch Prepack MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4695_888e7421-b947-4455-990e-93a213bdfaf9 63629-4695 HUMAN PRESCRIPTION DRUG Kadian morphine sulfate CAPSULE, EXTENDED RELEASE ORAL 20090407 NDA NDA020616 Bryant Ranch Prepack MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4697_ca63dfe6-ec06-4ef9-8626-65f381681fd0 63629-4697 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA079132 Bryant Ranch Prepack LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63629-4699_edd9fe1d-ef9c-4eac-8d4b-4903f3447a38 63629-4699 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Bryant Ranch Prepack ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-4707_e82c9ee4-aec1-496c-962a-30dbb83c46c9 63629-4707 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19871101 ANDA ANDA087499 Bryant Ranch Prepack CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 63629-4708_5cd37caa-f075-45ad-8707-5675cbd33d70 63629-4708 HUMAN PRESCRIPTION DRUG Zolpidem tartrate Zolpidem tartrate TABLET, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090107 Bryant Ranch Prepack ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 63629-4717_1e321783-8eed-4bb3-9e3a-ec8af510a778 63629-4717 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19971010 ANDA ANDA073568 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63629-4719_ec395446-2ce2-48aa-ac6b-1368b5f81e04 63629-4719 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Bryant Ranch Prepack SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] E 20171231 63629-4720_29d84e44-4b1d-4611-b609-8dd5c4254281 63629-4720 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Bryant Ranch Prepack SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] E 20171231 63629-4725_d284292a-8a21-49c3-909a-d13a6d91126b 63629-4725 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-4728_d55b7eb2-cd71-4c14-8b35-cbc1aa5d5d43 63629-4728 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA076999 Bryant Ranch Prepack CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 63629-4745_9805be6e-2ee4-41ef-bcc8-51103522daa6 63629-4745 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-4748_21914d2b-22e8-4a3f-9cdd-fc4389654479 63629-4748 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 Bryant Ranch Prepack WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 63629-4762_4d104dcb-1b0d-4fe6-90ec-aa5169005f83 63629-4762 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20080114 NDA NDA021234 Bryant Ranch Prepack DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-4764_3221a78a-8312-4ba7-b6af-1fd47b42910d 63629-4764 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Bryant Ranch Prepack FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4765_725a1c40-6fcb-4483-9aef-3dbac0d174f3 63629-4765 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Bryant Ranch Prepack FENTANYL 12.5 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-4768_778df04c-722f-448d-957c-afe68b3f31f3 63629-4768 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Bryant Ranch Prepack FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4771_34e261ca-6a09-4944-9344-316831a8953e 63629-4771 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Bryant Ranch Prepack FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4773_e4b3a428-7c83-4cee-aaa9-ebef684ad0e3 63629-4773 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Bryant Ranch Prepack FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4776_d46b01dc-daa4-45c5-989c-08885041a068 63629-4776 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-4778_d6595121-7d0f-44fa-a268-090db206e593 63629-4778 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040526 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 63629-4790_db18e5df-c35f-4fca-a68c-c4dc5012513f 63629-4790 HUMAN PRESCRIPTION DRUG Loratadine D Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20120119 ANDA ANDA076050 Bryant Ranch Prepack LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 63629-4792_e315a2e3-3a25-4b2b-8791-c373aaf308d6 63629-4792 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20070308 ANDA ANDA073671 Bryant Ranch Prepack NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 63629-4796_ad5de759-72d3-4078-b9ef-4f7e8bcbcfe5 63629-4796 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Bryant Ranch Prepack ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-4798_3bbcd9b2-83de-4367-b0ce-267ba122af24 63629-4798 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 63629-4801_9be9e74a-3d33-4a65-b769-6797cb2743e6 63629-4801 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Bryant Ranch Prepack ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-4805_81996542-6d21-4eb9-8ea6-ece2238f8ea5 63629-4805 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Bryant Ranch Prepack VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63629-4810_088c48fe-3e3c-4d97-b49a-f0b0d51dfa27 63629-4810 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20051229 ANDA ANDA076706 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63629-4813_ee776e4b-44f9-4e2c-a295-b6cd42c21bc6 63629-4813 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Bryant Ranch Prepack FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-4815_e52c5a1a-b471-4bda-8c36-7b97c7a5c5d2 63629-4815 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Bryant Ranch Prepack ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-4816_33b4f5b2-d4ed-484b-a190-0b148c71a7ef 63629-4816 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20110815 ANDA ANDA076470 Bryant Ranch Prepack DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] E 20171231 63629-4837_e9e48d50-5447-4380-b89f-51f040369a4a 63629-4837 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20070131 ANDA ANDA076588 Bryant Ranch Prepack VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 63629-4838_665b48ac-0702-4fbd-b97a-0d6f0867ac17 63629-4838 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL; SUBLINGUAL 20090921 UNAPPROVED DRUG OTHER Bryant Ranch Prepack HYOSCYAMINE SULFATE .125 mg/1 E 20171231 63629-4841_52deeea0-1166-473b-914d-3c3c3240d71e 63629-4841 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-4843_8e39007a-0a22-4a09-a4f5-fdacf380c08a 63629-4843 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET ORAL 20110620 ANDA ANDA090722 Bryant Ranch Prepack LEVOFLOXACIN 250 mg/1 E 20171231 63629-4849_a3c8dc3a-6fc3-4115-a00e-139ec72c1b34 63629-4849 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-4850_7a4a6069-b246-482c-b8e0-77e1322dbec5 63629-4850 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Bryant Ranch Prepack ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-4851_437e170a-2d0f-47c7-b071-2dd0c2e540c9 63629-4851 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120807 ANDA ANDA202319 Bryant Ranch Prepack LANSOPRAZOLE 15 mg/1 N 20181231 63629-4855_3489a7de-e6b4-4c7c-8837-958d692a29bb 63629-4855 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA201508 Bryant Ranch Prepack MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 63629-4865_103ce949-9c0d-4903-a3e1-8c2d27e40039 63629-4865 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Bryant Ranch Prepack ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63629-4872_4fd24d23-258b-4052-998d-fc3c34596d79 63629-4872 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20120515 ANDA ANDA202418 Bryant Ranch Prepack LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 63629-4878_cbf5a392-47e6-4f39-90fc-6ae62a277071 63629-4878 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20110103 ANDA ANDA078381 Bryant Ranch Prepack AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 63629-4886_2e051de5-4e18-4015-a722-726ebeb79e00 63629-4886 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, FILM COATED ORAL 20120803 ANDA ANDA200889 Bryant Ranch Prepack MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 63629-4888_ff84343a-0895-453c-be4c-e95b4af40b82 63629-4888 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA090528 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-4899_79ae9de8-c83c-4391-9960-fd5d4381af3c 63629-4899 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Bryant Ranch Prepack TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 63629-4900_6acb388a-75a9-4f0f-8023-d388b2a3d34b 63629-4900 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150701 NDA NDA022370 Bryant Ranch Prepack TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 63629-4901_18783b2e-a45f-4c40-9afd-82cc0eafd151 63629-4901 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Bryant Ranch Prepack TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV E 20171231 63629-4914_1f6c4fa3-41dd-4eee-bd89-50c108a5935e 63629-4914 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Bryant Ranch Prepack CETIRIZINE HYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 63629-4929_70f9e3cc-b145-439b-be7f-b3074166e7aa 63629-4929 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20120324 ANDA ANDA204279 Bryant Ranch Prepack HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63629-4931_0e7aabbb-a1d1-4325-b1d0-e56cb6932dd6 63629-4931 HUMAN PRESCRIPTION DRUG Fentanyl fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20100301 ANDA ANDA077775 Bryant Ranch Prepack FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-4939_fad9bf7e-6ff3-49b3-8c11-ac35a111bf12 63629-4939 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 63629-4941_2ba14274-152c-45fd-94d6-5f7705c868f3 63629-4941 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20071017 NDA NDA022122 Bryant Ranch Prepack DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-4947_fac85e50-b094-4604-8216-19c7099f66f0 63629-4947 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Bryant Ranch Prepack TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 63629-4964_e5406b4b-ca9a-4ad5-8565-435a9ae99bb9 63629-4964 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 63629-4968_b7184355-6449-484c-9c23-2092af302311 63629-4968 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 Bryant Ranch Prepack BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63629-4970_429dafb0-49ab-4f04-aa70-be2d7206012c 63629-4970 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121101 ANDA ANDA201089 Bryant Ranch Prepack DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 63629-4971_816eabba-6b66-4eb3-911d-e1f0b0d679e4 63629-4971 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 63629-4974_43d47e5b-f5de-41d7-9210-6ab5c034e69c 63629-4974 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Bryant Ranch Prepack FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-4975_fc07f89d-c748-461e-8753-96faabb4977b 63629-4975 HUMAN PRESCRIPTION DRUG FENTANYL FENTANYL PATCH, EXTENDED RELEASE TRANSDERMAL 20130404 ANDA ANDA077449 Bryant Ranch Prepack FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-4977_88db5bac-73c7-4b4f-a207-8f895223d778 63629-4977 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 63629-4978_751939ba-deec-4003-aecb-d2eb1975129c 63629-4978 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA202096 Bryant Ranch Prepack MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 63629-4987_23578bf9-d020-4206-b81b-fb37eba8c9d0 63629-4987 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Bryant Ranch Prepack OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-4994_71cce13d-b6ac-4dd2-8dfa-865e2e0f7d43 63629-4994 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, EXTENDED RELEASE ORAL 20030313 ANDA ANDA076174 Bryant Ranch Prepack ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-4998_af343f53-4686-4a04-a5b8-efdbf2dc9b84 63629-4998 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120927 ANDA ANDA202566 Bryant Ranch Prepack MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 63629-5007_03767a70-2a83-4c09-a787-116800b64c75 63629-5007 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071745 Bryant Ranch Prepack PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63629-5008_5ff7324f-e0aa-44fe-8f3f-016983c4f4f0 63629-5008 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060727 ANDA ANDA077636 Bryant Ranch Prepack ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63629-5013_3994aae2-57b6-4039-8858-6e1025b6cdcc 63629-5013 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Bryant Ranch Prepack PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 63629-5014_604a8e53-939c-4df7-8a43-069c5d3eca89 63629-5014 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20111117 ANDA ANDA202032 Bryant Ranch Prepack LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 63629-5027_0d682161-cdf7-49d6-8cad-5349dc484585 63629-5027 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20060604 ANDA ANDA071588 Bryant Ranch Prepack DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-5028_dca257de-c092-4652-980b-3c967e54d8a2 63629-5028 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20101221 ANDA ANDA090443 Bryant Ranch Prepack IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63629-5029_a7446e01-f478-4435-8e76-dc57f5ff596d 63629-5029 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET ORAL 20121108 ANDA ANDA202025 Bryant Ranch Prepack SILDENAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 63629-5032_b7bb0a8f-2deb-4e38-b3e4-eeca9e7c6966 63629-5032 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078385 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-5033_24e43851-3c01-4fc7-933a-3634f4232b36 63629-5033 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 Bryant Ranch Prepack DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-5034_0b5bd4fc-c750-4f85-afc3-a2a1e585575c 63629-5034 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100710 ANDA ANDA078920 Bryant Ranch Prepack PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 63629-5036_06e4b102-8e5d-4bd1-900e-be5e1d6ecd21 63629-5036 HUMAN PRESCRIPTION DRUG good neighbor pharmacy pain relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081103 ANDA ANDA075077 Bryant Ranch Prepack ACETAMINOPHEN 650 mg/1 E 20171231 63629-5038_0c5ad3e8-a196-457f-8ca8-063d33cf1261 63629-5038 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Bryant Ranch Prepack LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63629-5042_1abffcde-2237-41d7-955d-fc04c72843b7 63629-5042 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Bryant Ranch Prepack PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 63629-5065_64926d3d-60a5-405e-a703-c7d250cff8fe 63629-5065 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073556 Bryant Ranch Prepack NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 63629-5073_afecd5ca-20fc-45b9-ab29-98aeaffaf572 63629-5073 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077535 Bryant Ranch Prepack ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 63629-5074_ee6160a7-3fd1-4280-8d37-63a59cbf7227 63629-5074 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 Bryant Ranch Prepack BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII E 20171231 63629-5075_8ff5c83c-d0fa-45c4-8ef9-04566348d272 63629-5075 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20100719 ANDA ANDA091359 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 63629-5083_88bb02b6-1686-4172-a290-31be18ee800e 63629-5083 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077535 Bryant Ranch Prepack ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 63629-5085_488c7ab6-0376-45eb-9f9d-96c17449c059 63629-5085 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Bryant Ranch Prepack MIRTAZAPINE 15 mg/1 N 20181231 63629-5086_6e85d706-a5f7-4ae4-897d-9aa36852998d 63629-5086 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Bryant Ranch Prepack MIRTAZAPINE 30 mg/1 N 20181231 63629-5096_62ba5027-3196-4a30-9a04-5785769eb103 63629-5096 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 19960308 NDA AUTHORIZED GENERIC NDA020254 Bryant Ranch Prepack DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-5117_7e6cccb9-9485-4039-91a0-d08599f0b664 63629-5117 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20121130 ANDA ANDA078554 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63629-5139_208244a8-76c8-495c-b546-a54f0bf5bfe0 63629-5139 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 NDA NDA021447 Bryant Ranch Prepack TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 63629-5147_a5f8251a-7351-49a3-b872-3f8acff999ca 63629-5147 HUMAN PRESCRIPTION DRUG PAROXETINE HYDROCHLORIDE paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100913 NDA NDA020936 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63629-5174_4c389c0d-497c-4286-8e55-86155f9edcae 63629-5174 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090745 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63629-5198_0a26ba42-6b96-467d-ab38-4b35988184f3 63629-5198 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 19900930 ANDA ANDA089763 Bryant Ranch Prepack THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 63629-5202_5d2b82ea-1e64-49e2-92ac-91c3dff3de94 63629-5202 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090745 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63629-5208_87fb3a8f-4739-4790-b417-a476a45dd70a 63629-5208 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 Bryant Ranch Prepack ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 63629-5216_e48fd05e-79dc-4ebe-91c6-6e303cf0c1d7 63629-5216 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 20070102 ANDA ANDA074722 Bryant Ranch Prepack INDAPAMIDE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 63629-5219_6720ac23-fdba-41d5-984d-46c6867c10ae 63629-5219 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090425 Bryant Ranch Prepack DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 63629-5220_3d98793e-79cc-41e4-aebd-584c1a531457 63629-5220 HUMAN PRESCRIPTION DRUG FINASTERIDE FINASTERIDE TABLET, FILM COATED ORAL 20131105 ANDA ANDA078371 Bryant Ranch Prepack FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 63629-5223_fd2828a9-18ce-4ef5-8850-9ee05da2424f 63629-5223 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 63629-5237_c6b30c75-3b86-4ba3-abdd-d7f6ec5c5be5 63629-5237 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041221 ANDA ANDA075317 Bryant Ranch Prepack TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63629-5241_f8805d9a-8e0d-490a-8a98-ebd30e12ec30 63629-5241 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA202254 Bryant Ranch Prepack IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-5246_87d7dc05-84b1-4551-bcba-1eb20654a8fb 63629-5246 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Bryant Ranch Prepack HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 63629-5247_b1eeaf0b-ef49-42bc-9bbc-95a50b21d211 63629-5247 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Bryant Ranch Prepack LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-5256_6ff78500-11a5-41b1-aca2-b00898fb65de 63629-5256 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060401 ANDA ANDA076467 Bryant Ranch Prepack GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-5257_13b58f7b-fe92-4044-9e39-744cb61ba192 63629-5257 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Bryant Ranch Prepack WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 63629-5259_cda35538-1768-45c5-ad4e-5e3768fb5aa6 63629-5259 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 19810226 ANDA ANDA086831 Bryant Ranch Prepack CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 63629-5268_34102f7a-8f33-4929-84ca-0217aab07478 63629-5268 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Bryant Ranch Prepack LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-5269_39ba70b6-dd49-4ece-b9a9-6855b47c04f0 63629-5269 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100622 ANDA ANDA090568 Bryant Ranch Prepack ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 63629-5270_f1d032ff-f7fd-4cdb-a15c-8acf645fcdcd 63629-5270 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20120701 ANDA ANDA078355 Bryant Ranch Prepack DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 63629-5271_5488d06a-85bb-49b5-80ab-c30a5f6f85cc 63629-5271 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Bryant Ranch Prepack VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63629-5275_32e6929d-0e2b-4954-a2e5-b053082964dc 63629-5275 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20060228 ANDA ANDA077376 Bryant Ranch Prepack MIRTAZAPINE 45 mg/1 E 20171231 63629-5279_80189e37-1fe5-4d28-98dc-bbd20051a023 63629-5279 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Bryant Ranch Prepack FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63629-5284_e34dfaec-3d5d-4e67-ad4b-052a742d52f8 63629-5284 HUMAN PRESCRIPTION DRUG Ibuprofen and Pseudoephedrine hydrochloride ibuprofen and pseudoephedrine hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Bryant Ranch Prepack IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 63629-5291_b978ca08-81ae-4899-863a-81b4b56fd89d 63629-5291 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20031016 NDA NDA021487 Bryant Ranch Prepack MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 63629-5292_26bd5403-962a-48f7-a8a5-8685305645c0 63629-5292 HUMAN PRESCRIPTION DRUG BRILINTA Ticagrelor TABLET ORAL 20110805 NDA NDA022433 Bryant Ranch Prepack TICAGRELOR 90 mg/1 P2Y12 Platelet Inhibitor [EPC],Phenylalanine Hydroxylase Activators [MoA],Decreased Platelet Aggregation [PE],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 63629-5304_6cb61246-dc66-457c-a2ae-59da0dc55ccf 63629-5304 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 19980508 ANDA ANDA074918 Bryant Ranch Prepack NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] E 20171231 63629-5311_54c4bbf1-d096-4d9e-a8f1-b49af6c64a1e 63629-5311 HUMAN PRESCRIPTION DRUG Labetalol hydrochloride Labetalol hydrochloride TABLET, FILM COATED ORAL 19980803 ANDA ANDA075133 Bryant Ranch Prepack LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-5318_8c40c736-fa0f-45b0-99e1-c16466953831 63629-5318 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090745 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-5319_8664ca9c-b06f-4e2e-9864-1c7f01d5143e 63629-5319 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Bryant Ranch Prepack ESZOPICLONE 2 mg/1 CIV E 20171231 63629-5320_81a2399b-bcb0-45be-9c4c-aa25a03285be 63629-5320 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Bryant Ranch Prepack ESZOPICLONE 3 mg/1 CIV E 20171231 63629-5321_ba8eecbf-6ec8-4be0-b7b7-db7ffdf5f76f 63629-5321 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET ORAL 20090706 ANDA ANDA078917 Bryant Ranch Prepack BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 63629-5325_f19a9ea1-faf6-4b24-bfed-70a78d77febb 63629-5325 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Bryant Ranch Prepack ESZOPICLONE 1 mg/1 CIV E 20171231 63629-5341_6bc010b0-4520-4a1d-960b-afb0ba423198 63629-5341 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 Bryant Ranch Prepack SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 63629-5349_a6fdeecb-3f8c-46fd-9228-dddb9ec57b88 63629-5349 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 Bryant Ranch Prepack ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-5361_283f779d-8839-4e7d-a0ce-c7dc7d28c879 63629-5361 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate Doxycycline CAPSULE ORAL 20050207 NDA AUTHORIZED GENERIC NDA050641 Bryant Ranch Prepack DOXYCYCLINE 100 mg/1 E 20171231 63629-5364_a1d48fb0-adee-4f00-9ba1-64ae3765b34d 63629-5364 HUMAN PRESCRIPTION DRUG Alprazolam Extended Release Alprazolam TABLET, EXTENDED RELEASE ORAL 20070213 ANDA ANDA078056 Bryant Ranch Prepack ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63629-5366_006af2f4-012f-433e-aead-4710a8a5ec95 63629-5366 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110720 ANDA ANDA077179 Bryant Ranch Prepack AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 63629-5373_f20203b0-8d34-4662-8200-c8ae0abddb10 63629-5373 HUMAN PRESCRIPTION DRUG Chloroquine phosphate Chloroquine phosphate TABLET, FILM COATED ORAL 20110315 ANDA ANDA090610 Bryant Ranch Prepack CHLOROQUINE PHOSPHATE 250 mg/1 Antimalarial [EPC] E 20171231 63629-5388_f2e1b5fc-db48-4fa5-a933-9c12548c898d 63629-5388 HUMAN PRESCRIPTION DRUG Fenoprofen fenoprofen CAPSULE ORAL 20140714 NDA NDA017604 Bryant Ranch Prepack FENOPROFEN CALCIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-5409_bc159274-b336-4a20-8c23-bd0e4d18a717 63629-5409 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Bryant Ranch Prepack FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 63629-5415_7415c744-40a1-4867-bc93-089c8f24123f 63629-5415 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 Bryant Ranch Prepack HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63629-5418_bf755b96-958b-4a08-98e5-c46cb85cf804 63629-5418 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20111128 ANDA ANDA202170 Bryant Ranch Prepack FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63629-5422_3a697406-86f0-456f-85a6-277d5c8830d1 63629-5422 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 63629-5423_9503222d-3a0f-4198-a804-68c8e92cfe03 63629-5423 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20121030 ANDA ANDA090802 Bryant Ranch Prepack TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] E 20171231 63629-5424_0b952aaa-efd8-4417-ac27-96ae4a777992 63629-5424 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Bryant Ranch Prepack HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 63629-5428_c25d8e7a-71f2-4238-a281-501fe2878be4 63629-5428 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120517 ANDA ANDA040846 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 63629-5431_f294b157-b453-430d-958c-feb5a8aea36e 63629-5431 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20130510 ANDA ANDA077159 Bryant Ranch Prepack IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63629-5432_735b16f7-b6ab-4243-ba61-adc26c6d8252 63629-5432 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 63629-5434_79cdbbf2-f438-401b-9dc0-159761b1fc63 63629-5434 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040746 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 63629-5436_b197c754-5b28-4429-8407-0f9d3534c676 63629-5436 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040409 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 63629-5437_f20a0fd2-4d9c-4e31-8833-4ef0ab35af56 63629-5437 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Bryant Ranch Prepack HYDROCODONE BITARTRATE; IBUPROFEN 2.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII E 20171231 63629-5442_dd2e103a-6249-436d-9bd7-8f770c1d87c1 63629-5442 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20060926 ANDA ANDA040653 Bryant Ranch Prepack GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 63629-5450_044bcef0-e855-404d-a43e-c7debebf0518 63629-5450 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110114 ANDA ANDA090415 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 63629-5484_70b1403e-beae-4720-8028-4ee34481f74f 63629-5484 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20070511 ANDA ANDA076745 Bryant Ranch Prepack OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 63629-5492_1a698f7a-61d6-4bb7-893f-13823f208723 63629-5492 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Bryant Ranch Prepack FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-5496_3faf6571-66cb-4999-adac-9e0003a862fe 63629-5496 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Bryant Ranch Prepack FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-5498_c95630b3-78b0-4fca-9f12-da68582753c2 63629-5498 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Bryant Ranch Prepack ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 63629-5503_452bfda3-e71c-4523-94e8-99c328f22d77 63629-5503 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Bryant Ranch Prepack CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-5504_7363bc3b-aac5-4c49-a656-1a3330b30350 63629-5504 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Bryant Ranch Prepack CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63629-5513_711e6e4a-10e3-4b14-ada0-ba70ab374e10 63629-5513 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Bryant Ranch Prepack FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63629-5531_9e4a3274-589d-41a5-a3c2-78e1b926ca41 63629-5531 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil HCl atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20120727 NDA AUTHORIZED GENERIC NDA021078 Bryant Ranch Prepack ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 63629-5537_0e61cdd6-1a33-4ccb-8933-23db67b0339e 63629-5537 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20060228 ANDA ANDA077376 Bryant Ranch Prepack MIRTAZAPINE 45 mg/1 N 20181231 63629-5620_c61978a6-37aa-4bcb-acda-8380c0ad8cf9 63629-5620 HUMAN PRESCRIPTION DRUG FENTANYL TRANSDERMAL SYSTEM fentanyl transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 20110606 ANDA ANDA077154 Bryant Ranch Prepack FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63629-5632_daa86231-2377-4471-98b0-6a80ceed8a94 63629-5632 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130823 ANDA ANDA202366 Bryant Ranch Prepack LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 63629-5637_0f379aba-f28b-40b4-a2fc-d807829f2c70 63629-5637 HUMAN PRESCRIPTION DRUG Trezix acetaminophen, caffeine, dihydrocodeine bitartrate CAPSULE ORAL 20141201 ANDA ANDA204785 Bryant Ranch Prepack ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 320.5; 30; 16 mg/1; mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 63629-5641_f6af9fb2-3b72-40ec-a53c-f7d9eb9d71b3 63629-5641 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 63629-5650_b9281cd2-66f6-4935-8e9b-d92e8003d4bb 63629-5650 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Bryant Ranch Prepack GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-5659_f4f4d828-2424-4d04-9cb2-dcf236f437d3 63629-5659 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE ORAL 20151019 ANDA ANDA203636 Bryant Ranch Prepack ESOMEPRAZOLE MAGNESIUM 20 1/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63629-5688_384207d1-a538-4577-95c2-7c16c0b1ff83 63629-5688 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 19821001 ANDA ANDA085828 Bryant Ranch Prepack SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 63629-5696_32e0fbb2-5ccb-4c7f-a614-e8f0453d2a61 63629-5696 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Bryant Ranch Prepack HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 63629-5697_e1ab3772-d23b-4e7c-8525-44fa762a557f 63629-5697 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20110728 ANDA ANDA090912 Bryant Ranch Prepack ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 63629-5698_e1ab3772-d23b-4e7c-8525-44fa762a557f 63629-5698 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20110728 ANDA ANDA090912 Bryant Ranch Prepack ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 63629-5699_e1abbd9f-4dd8-4398-8c3b-1f6112ed0132 63629-5699 HUMAN PRESCRIPTION DRUG pyridostigmine bromide pyridostigmine bromide TABLET ORAL 20150807 ANDA ANDA205650 Bryant Ranch Prepack PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 63629-6308_64b2aac5-4dc1-473b-bfa7-64b1829ac429 63629-6308 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130128 NDA AUTHORIZED GENERIC NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6309_d470780f-bdca-4a6d-9cc2-c18b976e232f 63629-6309 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Bryant Ranch Prepack GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-6310_3c133f96-d4ef-4ee8-8707-2ad3114f29e8 63629-6310 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071972 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6311_bae94bd3-0ce0-4601-b5b3-8ae07ff1443f 63629-6311 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride amitriptyline hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-6315_477099be-4c6d-4e50-9183-80c6f6ae09f1 63629-6315 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 63629-6316_a24fc102-8b97-4d4e-897e-6eafb36dae5c 63629-6316 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Bryant Ranch Prepack SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 63629-6320_37febf11-39ce-470c-8619-9a2b84f4e067 63629-6320 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride CAPSULE ORAL 19991103 ANDA ANDA040319 Bryant Ranch Prepack DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 63629-6321_53bbdd8b-4918-4a8b-807a-6386cf5687c7 63629-6321 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20100315 ANDA ANDA040865 Bryant Ranch Prepack ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 63629-6324_aa53ddf0-b52d-4925-ac71-54ae23dceb5d 63629-6324 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078227 Bryant Ranch Prepack CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 63629-6325_3b15c653-06f4-418f-b672-e52c6f868b71 63629-6325 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130321 ANDA ANDA202389 Bryant Ranch Prepack ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6326_d209e875-c928-4ddd-bd1a-6fd9951689ee 63629-6326 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ASPIRIN 81 mg/1 N 20181231 63629-6327_79e55761-c7f4-4d8e-a879-02cbebb2cb49 63629-6327 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63629-6328_8edfca49-7704-4806-9aad-569e28d54c81 63629-6328 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19910731 ANDA ANDA063083 Bryant Ranch Prepack CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63629-6329_916f7b4a-99d6-4e0d-a064-a6dd9492a87f 63629-6329 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Bryant Ranch Prepack SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 63629-6330_a97ae374-43c3-4815-8400-41c56f47cc6f 63629-6330 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Bryant Ranch Prepack CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63629-6333_372fbc9c-19c4-4978-a428-af6b9acf0f48 63629-6333 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 Bryant Ranch Prepack INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-6334_46a9a56c-a39d-4a41-a805-9076729b3854 63629-6334 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63629-6338_39d07dae-3ed8-4548-b270-21b538bc2392 63629-6338 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Bryant Ranch Prepack VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63629-6339_624d6dac-1238-455d-a372-cea25b37dd4a 63629-6339 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 Bryant Ranch Prepack GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-6342_cecc7e09-bdb9-4709-b85c-bff7976f7e77 63629-6342 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Bryant Ranch Prepack WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 63629-6344_105b7c53-f119-40d7-a88e-5170773fedf7 63629-6344 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20110421 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ACETAMINOPHEN 325 mg/1 N 20181231 63629-6346_c1cb2368-ea55-4c67-9644-fc4d2e161b74 63629-6346 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Bryant Ranch Prepack LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6347_a373e336-37e5-4b77-a936-02691a15948e 63629-6347 HUMAN PRESCRIPTION DRUG Chlorthalidone chlorthalidone TABLET ORAL 19810226 ANDA ANDA086831 Bryant Ranch Prepack CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 63629-6349_6a254ee6-1639-47b7-b0d8-3574cbd84f29 63629-6349 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970430 ANDA ANDA074556 Bryant Ranch Prepack ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63629-6351_3b15c653-06f4-418f-b672-e52c6f868b71 63629-6351 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130319 ANDA ANDA202389 Bryant Ranch Prepack ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6352_112d268c-e014-4de3-95d0-acafaaa9c96d 63629-6352 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130128 NDA AUTHORIZED GENERIC NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6354_867a8a5c-5d28-4237-bfce-fe21747c5156 63629-6354 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA088467 Bryant Ranch Prepack HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 63629-6355_73b8be45-7bd0-4b30-80ac-d6d819d3c195 63629-6355 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20070511 ANDA ANDA076745 Bryant Ranch Prepack OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 63629-6356_35ec25c3-2510-4881-9177-46c86553ebf1 63629-6356 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ASPIRIN 81 mg/1 N 20181231 63629-6357_f9128136-cbf3-460a-bd23-f4356ad236dd 63629-6357 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19860825 ANDA ANDA071017 Bryant Ranch Prepack SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 63629-6358_01d1ae0e-c6dd-4bee-a776-6a99ab3cd236 63629-6358 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Bryant Ranch Prepack CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63629-6359_adf8a24f-2f4f-4aa9-9a9d-e14a48ec2999 63629-6359 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 20180923 ANDA ANDA077901 Bryant Ranch Prepack CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63629-6360_01d1ae0e-c6dd-4bee-a776-6a99ab3cd236 63629-6360 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Bryant Ranch Prepack CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 63629-6361_9eb4be46-4977-4f8b-ae34-c71695dfba88 63629-6361 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Bryant Ranch Prepack DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 63629-6362_d907826a-2478-4082-bbf1-720d4a1f708c 63629-6362 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077262 Bryant Ranch Prepack AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63629-6364_6e83825b-20c6-404b-82fc-0cc0affda33a 63629-6364 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20061212 ANDA ANDA040621 Bryant Ranch Prepack PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 63629-6365_144ea162-815c-45d4-b00b-22440b3df2fb 63629-6365 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Bryant Ranch Prepack LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-6366_a6760fdd-e8c3-4217-98f5-c57b047efe64 63629-6366 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 63629-6367_c620126d-4e30-4b10-a4ea-1b90450cad70 63629-6367 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Bryant Ranch Prepack TADALAFIL 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 63629-6368_f5de05ba-008f-4cdd-9f50-24dce418f08f 63629-6368 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Bryant Ranch Prepack CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-6369_1d439588-db0c-4c65-b128-25391232d019 63629-6369 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Bryant Ranch Prepack SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 63629-6370_2db013a6-839a-4325-82a2-c064c661ad78 63629-6370 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6371_108bbdbe-93a1-4ebb-9d3c-c73095566331 63629-6371 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 Bryant Ranch Prepack DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 63629-6372_97e8bf0d-e577-4cee-b14d-70f6835d0a84 63629-6372 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6376_6a254ee6-1639-47b7-b0d8-3574cbd84f29 63629-6376 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 Bryant Ranch Prepack ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63629-6377_e0ab2a3a-f05f-4071-a7c5-8ddf1ba09d7c 63629-6377 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19730112 ANDA ANDA083177 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-6378_99e1cbdf-66d8-47e3-9478-438a39b2689d 63629-6378 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 63629-6379_247b8401-a5c7-4244-9917-c292d4b2ba9d 63629-6379 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 Bryant Ranch Prepack METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 63629-6381_5bd44386-4017-4580-a2be-35607c488ce3 63629-6381 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Bryant Ranch Prepack LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63629-6382_a2619102-5b76-41a8-82c3-863aa99f9997 63629-6382 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20061212 ANDA ANDA040621 Bryant Ranch Prepack PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 63629-6386_071a1ca7-bf1d-4f8c-998b-b1e064beb9e5 63629-6386 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Bryant Ranch Prepack LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6388_eae9bd6e-d472-4fad-9e91-22a292f9f48e 63629-6388 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 ANDA ANDA090118 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 63629-6391_cef50777-e3fb-436d-843f-3f5f546aa0f5 63629-6391 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20121130 ANDA ANDA200295 Bryant Ranch Prepack LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 63629-6395_eb8d04b2-08b8-4a90-b24e-b52008d1f0f8 63629-6395 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20041216 ANDA ANDA076706 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63629-6397_fbd85cd0-ae20-4085-8b42-5da3a1739147 63629-6397 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Bryant Ranch Prepack METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 63629-6398_419de2c2-7b0a-4f9b-b150-1711fe26375d 63629-6398 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20060131 NDA NDA021908 Bryant Ranch Prepack LUBIPROSTONE 24 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] N 20181231 63629-6401_a98f8562-000d-4cb4-a1c2-4811e6625b84 63629-6401 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 20180228 ANDA ANDA040145 Bryant Ranch Prepack WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 63629-6403_d66edefe-c4b2-4e4e-99d4-abc343bd7c68 63629-6403 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 19981130 ANDA ANDA074739 Bryant Ranch Prepack AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 63629-6404_0656224f-1b28-4648-b7a4-94b43930921c 63629-6404 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19960916 NDA NDA019129 Bryant Ranch Prepack TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-6405_fe70c814-df68-4c39-ae95-d70de3c9d087 63629-6405 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018877 Bryant Ranch Prepack ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 63629-6406_b361cd59-5e39-4438-b6fc-67feb6d1d724 63629-6406 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077068 Bryant Ranch Prepack BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 63629-6408_5fd213cc-2e9d-4571-bc19-9c3a9b710322 63629-6408 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20000413 ANDA ANDA040350 Bryant Ranch Prepack METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 63629-6410_c1a04f73-588c-4360-aba5-e541dac009f2 63629-6410 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 Bryant Ranch Prepack GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-6413_77acf06e-2963-420f-96c2-2c4c76ea95c7 63629-6413 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Bryant Ranch Prepack GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-6415_51967c55-def0-42e1-8bd8-6360783971c7 63629-6415 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-6417_9b8eb3af-1cc5-4ca2-884e-348e751984e6 63629-6417 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 Bryant Ranch Prepack FOLIC ACID 1 mg/1 N 20181231 63629-6418_a06ef977-9fae-493b-af56-1d2e818fdeb2 63629-6418 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085967 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-6419_06847cde-adda-4d29-b9a0-96e06d2feb75 63629-6419 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-6421_d470780f-bdca-4a6d-9cc2-c18b976e232f 63629-6421 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Bryant Ranch Prepack GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-6422_e1c0d507-7203-416f-b924-c65b894fbf7a 63629-6422 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063181 Bryant Ranch Prepack MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 63629-6423_f1b38a95-2755-418c-9d0e-eb9cc28de42f 63629-6423 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19831110 NDA NDA018823 Bryant Ranch Prepack FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63629-6424_f16d819c-70a5-4b7d-a384-8b47a6c27ca4 63629-6424 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Bryant Ranch Prepack CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 63629-6425_4e15c08a-0252-49ff-bde9-4fbda27aaeb4 63629-6425 HUMAN PRESCRIPTION DRUG Escitalopram Escitslopram TABLET ORAL 20120910 ANDA ANDA078169 Bryant Ranch Prepack ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6427_97e8bf0d-e577-4cee-b14d-70f6835d0a84 63629-6427 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6428_d77fc7f5-b050-4bc0-a219-4f2470813c68 63629-6428 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200185 Bryant Ranch Prepack POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 63629-6430_686331a6-628b-4603-a235-4c5364940166 63629-6430 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19981120 ANDA ANDA074726 Bryant Ranch Prepack POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 63629-6431_63e71c1c-f039-4c37-b8a6-f95a000d8a81 63629-6431 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20090327 ANDA ANDA079153 Bryant Ranch Prepack TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63629-6432_3c6bdc23-8d69-464f-abda-29dadb813f08 63629-6432 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Bryant Ranch Prepack TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63629-6434_ddf61789-ffcd-42fe-867b-a12e9f4508d9 63629-6434 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 19990626 NDA NDA020897 Bryant Ranch Prepack OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 63629-6435_f16d819c-70a5-4b7d-a384-8b47a6c27ca4 63629-6435 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Bryant Ranch Prepack CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 63629-6436_c1cb2368-ea55-4c67-9644-fc4d2e161b74 63629-6436 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Bryant Ranch Prepack LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6438_7c55c74c-607b-4890-a3a0-d086dfeaff2d 63629-6438 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63629-6442_624d6dac-1238-455d-a372-cea25b37dd4a 63629-6442 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 Bryant Ranch Prepack GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-6443_526746a1-aaa0-4cec-b8e2-a8cafa930d7f 63629-6443 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 Bryant Ranch Prepack ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6447_df6c5710-2989-44b9-9c46-b935c8d09713 63629-6447 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Bryant Ranch Prepack CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 63629-6448_06847cde-adda-4d29-b9a0-96e06d2feb75 63629-6448 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-6449_9f5af5fb-19f7-4054-9fc1-9841502f5608 63629-6449 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20040211 ANDA ANDA076211 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63629-6451_79b9e13e-477e-479c-a8e3-948d2b9897f2 63629-6451 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Bryant Ranch Prepack METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6452_5d40a578-72d3-4024-8f6b-2aa61a8405ec 63629-6452 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 63629-6453_3f38d848-022b-4c4b-bf9b-b215c6309d4d 63629-6453 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Bryant Ranch Prepack CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 63629-6454_112d268c-e014-4de3-95d0-acafaaa9c96d 63629-6454 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130128 NDA AUTHORIZED GENERIC NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6458_38cfba05-86a3-4a03-8c33-9135911fe611 63629-6458 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070975 Bryant Ranch Prepack CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63629-6459_191438b5-eba1-4aea-9d93-0006f3e8658a 63629-6459 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160209 NDA AUTHORIZED GENERIC NDA021656 Bryant Ranch Prepack FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 63629-6461_5ebe0585-f29d-4ed7-b65b-6b6e12d79e2e 63629-6461 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073025 Bryant Ranch Prepack ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6462_212d701b-f094-449c-a535-426ed7b3c1bf 63629-6462 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 19940527 ANDA ANDA074217 Bryant Ranch Prepack METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6463_6210a7f5-4149-4cd7-885e-03a242b87e1b 63629-6463 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-6464_e535c57b-b453-4009-b0f6-20407c1292ee 63629-6464 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20061004 ANDA ANDA077912 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-6467_2af80fbb-e0c4-4fe5-af59-942e7a9f2c26 63629-6467 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Bryant Ranch Prepack ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 63629-6473_5e88b7d5-2038-404c-8c9b-232c6d3753a2 63629-6473 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150923 ANDA ANDA078866 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63629-6476_daa63910-9686-41fa-b023-13b0cff8103f 63629-6476 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Bryant Ranch Prepack GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-6482_526746a1-aaa0-4cec-b8e2-a8cafa930d7f 63629-6482 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950217 ANDA ANDA074056 Bryant Ranch Prepack ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6508_fe70c814-df68-4c39-ae95-d70de3c9d087 63629-6508 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018832 Bryant Ranch Prepack ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 63629-6511_6473bc37-fc51-4373-9446-5fe7c998ff9b 63629-6511 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Bryant Ranch Prepack CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 63629-6512_beff5c11-38ee-46da-bf2c-725635b39103 63629-6512 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6513_c81a9079-f743-4762-949a-af49748aa146 63629-6513 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Bryant Ranch Prepack CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63629-6518_917af184-cb06-4edc-aa2a-6099512e7549 63629-6518 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20100723 ANDA ANDA091176 Bryant Ranch Prepack HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63629-6519_29c803aa-f692-441c-9092-952927759f7f 63629-6519 HUMAN PRESCRIPTION DRUG IBUPROFEN Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Bryant Ranch Prepack IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-6520_29c803aa-f692-441c-9092-952927759f7f 63629-6520 HUMAN PRESCRIPTION DRUG IBUPROFEN Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Bryant Ranch Prepack IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-6521_d6c04d68-66e1-4c68-beb8-220f7e0435a7 63629-6521 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 Bryant Ranch Prepack LEVOFLOXACIN 500 mg/1 N 20181231 63629-6524_0df22510-3c9c-498b-9a72-f7b053dc528c 63629-6524 HUMAN PRESCRIPTION DRUG Jentadueto linagliptin and metformin hydrochloride TABLET, FILM COATED ORAL 20120213 NDA NDA201281 Bryant Ranch Prepack LINAGLIPTIN; METFORMIN HYDROCHLORIDE 2.5; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63629-6525_144ea162-815c-45d4-b00b-22440b3df2fb 63629-6525 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Bryant Ranch Prepack LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-6526_144ea162-815c-45d4-b00b-22440b3df2fb 63629-6526 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Bryant Ranch Prepack LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-6528_0b01f3b3-0ab3-433c-9f97-0411c891d5f9 63629-6528 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-6529_78ac5567-34c1-465a-a1d9-9c2fcb83f1c7 63629-6529 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63629-6530_78ac5567-34c1-465a-a1d9-9c2fcb83f1c7 63629-6530 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63629-6531_d3b3fe1e-086e-4b78-9b17-123071d96984 63629-6531 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20070802 NDA AUTHORIZED GENERIC NDA019962 Bryant Ranch Prepack METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6532_79b9e13e-477e-479c-a8e3-948d2b9897f2 63629-6532 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Bryant Ranch Prepack METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6533_d2ced999-5574-4f95-ad3e-d72255e4fdfd 63629-6533 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071219 ANDA ANDA077056 Bryant Ranch Prepack PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 63629-6534_9c36588c-9751-4532-bdd4-83f600d8f538 63629-6534 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20140901 ANDA ANDA074726 Bryant Ranch Prepack POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 63629-6535_8bb983c2-9e38-4e3d-9c8c-74e0229b94a3 63629-6535 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961101 NDA AUTHORIZED GENERIC NDA018333 Bryant Ranch Prepack SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 63629-6537_05a8bfb6-2611-43f2-88c6-d84497568a84 63629-6537 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20020627 ANDA ANDA076280 Bryant Ranch Prepack TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63629-6539_46a9a56c-a39d-4a41-a805-9076729b3854 63629-6539 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63629-6540_cef50777-e3fb-436d-843f-3f5f546aa0f5 63629-6540 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20121203 ANDA ANDA200295 Bryant Ranch Prepack LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 63629-6613_2a8b7c08-f20e-4a62-bfea-c0815dfd1689 63629-6613 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20150129 ANDA ANDA204339 Bryant Ranch Prepack RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63629-6621_469767c4-e5c7-4f83-9876-0e0db049bf07 63629-6621 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 Bryant Ranch Prepack PREDNISONE 10 mg/1 N 20191231 63629-6630_24e012a6-a182-46e1-8fcf-ecffb5b9fb7c 63629-6630 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-6631_e6098d6c-95f4-42c7-9e0a-16d42206b5e9 63629-6631 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Bryant Ranch Prepack AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63629-6632_2a2c92f1-319c-4971-a2ab-c13ad2e9d41e 63629-6632 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070709 ANDA ANDA077262 Bryant Ranch Prepack AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63629-6633_dd55146e-9813-4b3e-ac6f-d6907c5e0d0f 63629-6633 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6634_112d268c-e014-4de3-95d0-acafaaa9c96d 63629-6634 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130128 NDA AUTHORIZED GENERIC NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6635_32865251-8b9b-4b32-aa70-d75795f32647 63629-6635 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Bryant Ranch Prepack BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 63629-6636_a97ae374-43c3-4815-8400-41c56f47cc6f 63629-6636 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Bryant Ranch Prepack CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63629-6637_92789ae4-502a-4c5e-967e-c195c452ba1b 63629-6637 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20001201 ANDA ANDA065055 Bryant Ranch Prepack DOXYCYCLINE 100 mg/1 N 20181231 63629-6638_6d6d3321-7e21-4393-9b20-9935b1f88eb6 63629-6638 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20010123 ANDA ANDA075657 Bryant Ranch Prepack ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 63629-6639_02677a99-a74b-4334-b4ae-2c6096821ae2 63629-6639 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Bryant Ranch Prepack GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-6642_b353c0ed-f874-45d4-86f2-7615dd597442 63629-6642 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20140627 ANDA ANDA087479 Bryant Ranch Prepack HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63629-6646_95087193-78b4-4aa0-a115-f53f8ccb45dd 63629-6646 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 63629-6647_06847cde-adda-4d29-b9a0-96e06d2feb75 63629-6647 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-6648_4ec87f23-15f6-4c43-ae20-6e6f541e8a09 63629-6648 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-6651_144ea162-815c-45d4-b00b-22440b3df2fb 63629-6651 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Bryant Ranch Prepack LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-6652_0b01f3b3-0ab3-433c-9f97-0411c891d5f9 63629-6652 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20061004 ANDA ANDA077912 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-6653_8333f506-c8ff-45e2-ab1f-8aebff7b414d 63629-6653 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Bryant Ranch Prepack NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 63629-6654_2fd0e9f4-ae79-4461-9a85-fe9f4f15f758 63629-6654 HUMAN OTC DRUG Rugby Meclizine HCl, 12.5 mg Each Antiemetic Meclizine HCl TABLET ORAL 20140307 OTC MONOGRAPH FINAL part336 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 63629-6655_243a7948-f730-44d0-846e-89e9a3b908b1 63629-6655 HUMAN OTC DRUG Rugby Travel Sickness Meclizine HCl, 25 mg Each (Antiemetic) Meclizine HCl TABLET, CHEWABLE ORAL 20140819 OTC MONOGRAPH FINAL part336 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 63629-6656_0a9dca88-a89d-45f2-be82-8f688d64f4d0 63629-6656 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Bryant Ranch Prepack NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-6659_469767c4-e5c7-4f83-9876-0e0db049bf07 63629-6659 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 Bryant Ranch Prepack PREDNISONE 20 mg/1 N 20191231 63629-6690_460b0b84-ce16-4284-a9b0-c6124799110a 63629-6690 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Bryant Ranch Prepack BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 63629-6691_4da3f687-8e64-4afb-9326-66af702df7a1 63629-6691 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20080728 ANDA ANDA077042 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6692_ba1eaa6f-7334-4d12-b745-c8dc5e0eff3f 63629-6692 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 Bryant Ranch Prepack FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 63629-6694_02518e63-7d87-4c8a-8812-1e658957491c 63629-6694 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 Bryant Ranch Prepack FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63629-6699_06847cde-adda-4d29-b9a0-96e06d2feb75 63629-6699 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-6700_06847cde-adda-4d29-b9a0-96e06d2feb75 63629-6700 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-6703_f9ca72d1-8f14-48b3-8a60-e224b5822d15 63629-6703 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-6704_e535c57b-b453-4009-b0f6-20407c1292ee 63629-6704 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-6706_87da0d88-bbfb-4816-82be-57c16e310a2d 63629-6706 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 Bryant Ranch Prepack MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-6707_642290e4-8cb5-439d-a965-669cc077cd24 63629-6707 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060719 ANDA ANDA077944 Bryant Ranch Prepack MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-6709_6f051633-ebf9-499b-9ea4-a79ab5fc3468 63629-6709 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Bryant Ranch Prepack ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 63629-6711_46a9a56c-a39d-4a41-a805-9076729b3854 63629-6711 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63629-6712_0656224f-1b28-4648-b7a4-94b43930921c 63629-6712 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19960916 NDA NDA019129 Bryant Ranch Prepack TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-6716_ff011d77-99be-4215-ae46-b3ec88eceb03 63629-6716 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 Bryant Ranch Prepack HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63629-6717_0be49f9a-8996-49f7-87a9-1a2fc3a6779f 63629-6717 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Bryant Ranch Prepack METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6750_06847cde-adda-4d29-b9a0-96e06d2feb75 63629-6750 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-6755_47d1b056-6c87-44de-ae3d-67b2425eabee 63629-6755 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA AUTHORIZED GENERIC NDA019839 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6757_1344cfe5-64cc-4d0e-a17c-787060a18dc0 63629-6757 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Bryant Ranch Prepack RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63629-6758_56458cba-a2c8-4a4a-ab24-57dc0d794ea9 63629-6758 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 Bryant Ranch Prepack PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6761_1e6cd4d8-e994-4588-ab24-d1142ae38d4e 63629-6761 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6762_d3b3fe1e-086e-4b78-9b17-123071d96984 63629-6762 HUMAN PRESCRIPTION DRUG METOPROLOL SUCCINATE Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20061121 NDA AUTHORIZED GENERIC NDA019962 Bryant Ranch Prepack METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6763_d5fe8d5a-2b4f-4d54-89e9-7b2fe427bf14 63629-6763 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20050825 ANDA ANDA065136 Bryant Ranch Prepack CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63629-6764_214b1950-bf0e-4c87-a3d7-9902d5ab4377 63629-6764 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 20020524 NDA AUTHORIZED GENERIC NDA050784 Bryant Ranch Prepack AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 63629-6768_0bf16d40-9eb5-4e5f-a7bf-5a03280507f1 63629-6768 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6769_c620126d-4e30-4b10-a4ea-1b90450cad70 63629-6769 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Bryant Ranch Prepack TADALAFIL 5 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 63629-6770_17699012-a5de-4070-8994-0f1cd2b7b6d4 63629-6770 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 Bryant Ranch Prepack FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6771_32865251-8b9b-4b32-aa70-d75795f32647 63629-6771 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Bryant Ranch Prepack BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 63629-6776_dd55146e-9813-4b3e-ac6f-d6907c5e0d0f 63629-6776 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Bryant Ranch Prepack ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6777_17c4cc91-9876-411a-a9df-7bf007066b08 63629-6777 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin CAPSULE ORAL 20110525 NDA NDA020064 Bryant Ranch Prepack NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 63629-6789_beff5c11-38ee-46da-bf2c-725635b39103 63629-6789 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6790_33abe8e6-3761-429e-894c-c835ae123b44 63629-6790 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine TABLET, FILM COATED ORAL 20131223 ANDA ANDA075755 Bryant Ranch Prepack FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6791_43b82be8-1b39-407c-a2dc-5db42efe6f90 63629-6791 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Bryant Ranch Prepack GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-6792_5cc3aaf4-4076-44d7-b13d-b4a2ef5e5770 63629-6792 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Bryant Ranch Prepack GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-6794_75dd77a5-f54e-4480-9d3b-28d9baaaba1a 63629-6794 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020211 ANDA ANDA075978 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63629-6797_01cbe0c7-8822-49e4-8f1b-46f986d3e824 63629-6797 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ACETAMINOPHEN 500 mg/1 N 20181231 63629-6799_f9128136-cbf3-460a-bd23-f4356ad236dd 63629-6799 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19860825 ANDA ANDA071017 Bryant Ranch Prepack SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 63629-6804_4c14131f-8a8c-4d5f-9571-2b5a66797425 63629-6804 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20120724 ANDA ANDA070085 Bryant Ranch Prepack METHYLDOPA 500 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63629-6805_d2071a3d-a366-4802-9d44-b9834deeada6 63629-6805 HUMAN PRESCRIPTION DRUG Omega-3-Acid Ethyl Esters omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20140630 ANDA ANDA091018 Bryant Ranch Prepack OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 63629-6807_6d9002b9-8b44-42e5-8a67-402a5333d52e 63629-6807 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 Bryant Ranch Prepack TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63629-6809_50366b0f-018b-4d35-b7b5-0a8502c9286e 63629-6809 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20100730 NDA NDA019781 Bryant Ranch Prepack PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 63629-6810_0a9dca88-a89d-45f2-be82-8f688d64f4d0 63629-6810 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Bryant Ranch Prepack NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-6812_eff960db-8225-4a8b-9812-a55073dd5f40 63629-6812 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 Bryant Ranch Prepack MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 63629-6817_6ab63067-2980-487e-93d1-efba50650333 63629-6817 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20120423 ANDA ANDA075467 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 7.5 mg/1 N 20181231 63629-6818_d71e2209-7ca4-42f2-ac52-e79cb47fa155 63629-6818 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20020301 ANDA ANDA076008 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 63629-6820_3093c922-8384-4e72-a8e8-15d7e9a5cf9a 63629-6820 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 Bryant Ranch Prepack DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 63629-6823_b46f6895-6e97-4418-a0b9-46885d11f9ab 63629-6823 HUMAN OTC DRUG FERROUS SULFATE IRON SUPPLEMENT TABLET ORAL 20010219 UNAPPROVED DRUG OTHER Bryant Ranch Prepack FERROUS SULFATE 325 mg/1 N 20181231 63629-6831_c62fe738-4c98-4769-a985-53c7dfe59fc0 63629-6831 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Bryant Ranch Prepack TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 63629-6834_5ded3c1f-5263-4bf8-8ea7-a1a4fcfcaa38 63629-6834 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 Bryant Ranch Prepack OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-6836_d1c32df7-665b-44de-89b5-372327690331 63629-6836 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Bryant Ranch Prepack LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-6837_06847cde-adda-4d29-b9a0-96e06d2feb75 63629-6837 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-6838_06847cde-adda-4d29-b9a0-96e06d2feb75 63629-6838 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 63629-6840_77acf06e-2963-420f-96c2-2c4c76ea95c7 63629-6840 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Bryant Ranch Prepack GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-6843_10af2035-8f38-4bcc-9294-7f9f1bde9bc0 63629-6843 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Bryant Ranch Prepack DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-6844_42f4f49e-1296-4e30-9c41-bd0824bc4c91 63629-6844 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, COATED ORAL 20110802 UNAPPROVED DRUG OTHER Bryant Ranch Prepack PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 63629-6845_04c1b7bc-3865-48eb-be1c-8988f2c737a3 63629-6845 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Bryant Ranch Prepack LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-6846_42f4f49e-1296-4e30-9c41-bd0824bc4c91 63629-6846 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, COATED ORAL 20110802 UNAPPROVED DRUG OTHER Bryant Ranch Prepack PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 63629-6852_f8b66591-140a-48c4-98a3-feb4dc949648 63629-6852 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Bryant Ranch Prepack METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 63629-6853_963ba0a0-6490-4bba-a3ed-f4a24990427e 63629-6853 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20140414 ANDA ANDA204234 Bryant Ranch Prepack DOXYCYCLINE 100 mg/1 N 20181231 63629-6854_ad755c71-418f-4747-998e-52b62b02137f 63629-6854 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20110408 ANDA ANDA091619 Bryant Ranch Prepack DISULFIRAM 500 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 63629-6855_02b3a8d0-fcdb-4089-980c-8fa7832d1567 63629-6855 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20010802 ANDA ANDA075049 Bryant Ranch Prepack FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6857_cf66090e-527f-4f42-9892-7f39ddadd7bf 63629-6857 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 Bryant Ranch Prepack CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 63629-6871_207666fe-4aed-4c23-9467-982c0997af3d 63629-6871 HUMAN PRESCRIPTION DRUG Topiramate Topiramate CAPSULE, COATED PELLETS ORAL 20090417 ANDA ANDA076575 Bryant Ranch Prepack TOPIRAMATE 15 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63629-6873_03767a70-2a83-4c09-a787-116800b64c75 63629-6873 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071745 Bryant Ranch Prepack PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63629-6875_bbb4cdb4-8d3c-4f31-af3c-1275b829b463 63629-6875 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 63629-6880_288da6ec-57ca-498a-a68b-7dda55050f64 63629-6880 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19860710 ANDA ANDA062677 Bryant Ranch Prepack DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 63629-6881_ebd66b06-7985-4a98-b49b-2863d41ee7c3 63629-6881 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071976 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6883_4cd93bd8-e70a-4834-8fee-38baf4fb46a2 63629-6883 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072234 Bryant Ranch Prepack BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 63629-6884_dcd999b6-2be5-44c9-a2cd-4ac87f11a76e 63629-6884 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6885_dcd999b6-2be5-44c9-a2cd-4ac87f11a76e 63629-6885 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6887_ebd66b06-7985-4a98-b49b-2863d41ee7c3 63629-6887 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071973 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6892_3298f143-3957-4b9b-896f-0ea19c4a60b8 63629-6892 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA203311 Bryant Ranch Prepack VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63629-6897_f64841f0-f619-4294-a1c1-5ef5911e9165 63629-6897 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 Bryant Ranch Prepack FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 63629-6905_3298f143-3957-4b9b-896f-0ea19c4a60b8 63629-6905 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA203311 Bryant Ranch Prepack VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63629-6916_e1758692-f875-4d83-b300-f0da5f64e7e2 63629-6916 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Bryant Ranch Prepack ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 63629-6922_ba3e4936-23a0-4dc7-9e59-6a1220de1e66 63629-6922 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20140707 NDA AUTHORIZED GENERIC NDA021283 Bryant Ranch Prepack VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63629-6923_08db3a72-5603-44ab-9b26-e4da689fb37a 63629-6923 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Bryant Ranch Prepack VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-6924_97e8bf0d-e577-4cee-b14d-70f6835d0a84 63629-6924 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6927_d63ab6d4-a98e-425b-912d-b2c47a222eb0 63629-6927 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20140414 ANDA ANDA204234 Bryant Ranch Prepack DOXYCYCLINE 100 mg/1 N 20181231 63629-6928_b840a9c4-3fe4-479a-8264-f534f78d4511 63629-6928 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20030911 ANDA ANDA076577 Bryant Ranch Prepack MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 63629-6929_56458cba-a2c8-4a4a-ab24-57dc0d794ea9 63629-6929 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 Bryant Ranch Prepack PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6930_d470780f-bdca-4a6d-9cc2-c18b976e232f 63629-6930 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20051006 ANDA ANDA077091 Bryant Ranch Prepack GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-6931_56458cba-a2c8-4a4a-ab24-57dc0d794ea9 63629-6931 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 Bryant Ranch Prepack PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-6932_dcd999b6-2be5-44c9-a2cd-4ac87f11a76e 63629-6932 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63629-6933_c6b30c75-3b86-4ba3-abdd-d7f6ec5c5be5 63629-6933 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Bryant Ranch Prepack TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 63629-6934_c33f0727-28e2-44f4-b423-079afec4f805 63629-6934 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070175 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6935_b44a0714-ac43-411e-9d57-fdf1ec32a502 63629-6935 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20150908 OTC MONOGRAPH FINAL part331 Bryant Ranch Prepack MAGNESIUM OXIDE 400 mg/1 N 20181231 63629-6939_82c79943-87b7-4209-ab83-244f7e9d985c 63629-6939 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110930 ANDA ANDA090692 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63629-6942_695ecbd9-d315-4a14-923a-c223d2e4116a 63629-6942 HUMAN PRESCRIPTION DRUG Nadolol nadolol TABLET ORAL 19931031 ANDA ANDA074172 Bryant Ranch Prepack NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-6947_bf89943b-695b-4d66-9157-f840583adccf 63629-6947 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Bryant Ranch Prepack DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-6973_7b151e88-bf5a-41f5-b874-da77c1507a82 63629-6973 HUMAN PRESCRIPTION DRUG PNV Prenatal Plus Multivitamin VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, and CUPRIC OXIDE TABLET ORAL 20130401 UNAPPROVED DRUG OTHER Bryant Ranch Prepack VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE 2000; 2000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 63629-6975_37afcab1-403c-45b8-a001-56a86e3d19d6 63629-6975 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA078245 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63629-6977_cecc7e09-bdb9-4709-b85c-bff7976f7e77 63629-6977 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Bryant Ranch Prepack WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 63629-6983_97e02a42-95f0-441f-8c3f-0315b0450a18 63629-6983 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Bryant Ranch Prepack GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-6993_9be85a63-ddd3-483b-8e2e-6549c0e0793f 63629-6993 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA079245 Bryant Ranch Prepack FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-6994_89bb972a-04d2-4219-acda-3753cd9fff34 63629-6994 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20070917 ANDA ANDA077222 Bryant Ranch Prepack FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-6999_8c5454da-ad30-4f54-82bd-811bfaf207be 63629-6999 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 Bryant Ranch Prepack ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 63629-7002_21dd8fb2-fbec-4b43-963e-5af05aeb0b39 63629-7002 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Bryant Ranch Prepack LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 63629-7003_8c5454da-ad30-4f54-82bd-811bfaf207be 63629-7003 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 Bryant Ranch Prepack ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 63629-7013_f4b79fa7-8ca1-4513-b770-76c4228dcfea 63629-7013 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Bryant Ranch Prepack FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63629-7017_8c5454da-ad30-4f54-82bd-811bfaf207be 63629-7017 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 Bryant Ranch Prepack ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 63629-7020_a25f0c76-e3f5-4260-bd84-9977684a8609 63629-7020 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20130118 ANDA ANDA201791 Bryant Ranch Prepack LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 63629-7021_f1aaad63-32f6-483d-850c-631c071f1186 63629-7021 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 63629-7023_1037663b-92b6-41f5-84c9-5b096f1859f9 63629-7023 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 63629-7033_c717d7bd-033b-4913-b783-3a670697d865 63629-7033 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090501 ANDA ANDA077415 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 63629-7034_429dafb0-49ab-4f04-aa70-be2d7206012c 63629-7034 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121101 ANDA ANDA201089 Bryant Ranch Prepack DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 63629-7037_8a589672-5032-464a-b55e-33a5434180b1 63629-7037 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20031211 ANDA ANDA076416 Bryant Ranch Prepack TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63629-7039_fa4649ba-93af-4b89-ae58-b6c25cfd37ac 63629-7039 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20010820 ANDA ANDA075189 Bryant Ranch Prepack NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-7045_cd46dab8-f0d8-4e47-94e7-1297a685d527 63629-7045 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Bryant Ranch Prepack ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 63629-7046_ea8d5e0d-d757-4d8b-81ae-65f34f4fe890 63629-7046 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Bryant Ranch Prepack NEFAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63629-7050_6926d498-f3e0-4380-b4fd-69e60eef8c00 63629-7050 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Bryant Ranch Prepack LEVOFLOXACIN 750 mg/1 N 20181231 63629-7057_b0814808-31dd-41dd-ae71-83bc4c44969c 63629-7057 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-7067_172e7fd1-cfd5-4323-b393-c2326d448f04 63629-7067 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100406 ANDA ANDA091256 Bryant Ranch Prepack BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 63629-7069_44471e18-0015-4eda-956a-f2f590aea3d2 63629-7069 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium GEL TOPICAL 20160701 NDA AUTHORIZED GENERIC NDA022122 Bryant Ranch Prepack DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-7086_6bc9a519-c67b-40bb-b05b-6ee6e5be46a2 63629-7086 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20140728 ANDA ANDA077491 Bryant Ranch Prepack PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-7087_673c87b8-ad58-42cb-9c7e-df116b45c5dd 63629-7087 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040788 Bryant Ranch Prepack HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63629-7089_9e157d8d-a0dc-45dd-802f-e1c88f07c93f 63629-7089 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20101227 ANDA ANDA077714 Bryant Ranch Prepack TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 63629-7090_842766db-d8bb-4fc0-bf16-ee600eb2b74c 63629-7090 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine TABLET ORAL 20150711 ANDA ANDA079225 Bryant Ranch Prepack MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 63629-7091_56c22f3f-3067-4f24-a24d-64eb9288d660 63629-7091 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140602 ANDA ANDA202419 Bryant Ranch Prepack DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 63629-7093_7306c47f-9150-4dec-92b8-465ef707da4a 63629-7093 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150702 ANDA ANDA076467 Bryant Ranch Prepack GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63629-7104_e1758692-f875-4d83-b300-f0da5f64e7e2 63629-7104 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride Ziprasidone HCl CAPSULE ORAL 20120514 ANDA ANDA077561 Bryant Ranch Prepack ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 63629-7108_8c5454da-ad30-4f54-82bd-811bfaf207be 63629-7108 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 Bryant Ranch Prepack ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 63629-7114_fad9bf7e-6ff3-49b3-8c11-ac35a111bf12 63629-7114 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 63629-7115_d057e6e0-86f7-4b89-ab0b-aac02c4b7b55 63629-7115 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20120703 NDA NDA021282 Bryant Ranch Prepack GUAIFENESIN 600 mg/1 N 20181231 63629-7116_fad9bf7e-6ff3-49b3-8c11-ac35a111bf12 63629-7116 HUMAN PRESCRIPTION DRUG QUETIAPINE FUMARATE Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 63629-7122_b2e895f6-8071-43bb-a7e0-0abccb48a7ba 63629-7122 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20100719 ANDA ANDA091359 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 63629-7125_b499a74c-36d6-4262-b281-7372096d5a5c 63629-7125 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 Bryant Ranch Prepack BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 63629-7126_b499a74c-36d6-4262-b281-7372096d5a5c 63629-7126 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 Bryant Ranch Prepack BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 63629-7128_e61af639-a134-4581-bc34-4abef5bd18ba 63629-7128 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 20150420 ANDA ANDA074903 Bryant Ranch Prepack ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-7129_8b478be1-27e5-467a-967a-14afb08d28d7 63629-7129 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE TABLET, DELAYED RELEASE ORAL 20140910 ANDA ANDA202882 Bryant Ranch Prepack PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 63629-7132_95087193-78b4-4aa0-a115-f53f8ccb45dd 63629-7132 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Bryant Ranch Prepack LEVOTHYROXINE SODIUM .3 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 63629-7137_5d40a578-72d3-4024-8f6b-2aa61a8405ec 63629-7137 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 63629-7138_d627fd5e-2ba3-4817-bcd2-d5339616387d 63629-7138 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20141201 ANDA ANDA200881 Bryant Ranch Prepack GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 63629-7139_5d40a578-72d3-4024-8f6b-2aa61a8405ec 63629-7139 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 63629-7145_c620126d-4e30-4b10-a4ea-1b90450cad70 63629-7145 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Bryant Ranch Prepack TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 63629-7146_b0814808-31dd-41dd-ae71-83bc4c44969c 63629-7146 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-7150_b6af1721-540b-4313-875f-1a890fff2292 63629-7150 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE 6.25; 5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-7151_9270cb94-b292-4dc6-b1cb-18deb2d95ebd 63629-7151 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Bryant Ranch Prepack FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 63629-7152_1037663b-92b6-41f5-84c9-5b096f1859f9 63629-7152 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 63629-7153_28a7578c-c1af-4c3e-a05f-61570d7413e7 63629-7153 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 Bryant Ranch Prepack METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-7154_9f0cc8c1-9baa-4134-89b8-a7b0f3678584 63629-7154 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20151013 ANDA ANDA203175 Bryant Ranch Prepack MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 63629-7157_031a53a7-1242-4a23-bd85-c76af68cd8b3 63629-7157 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-7158_0f9db9d7-1fea-4254-872b-7418949cfe2b 63629-7158 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, COATED ORAL 20161031 ANDA ANDA201619 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-7161_823f19e7-19ba-4957-8bd9-b0dc22519e88 63629-7161 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20160502 ANDA ANDA079167 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-7166_469767c4-e5c7-4f83-9876-0e0db049bf07 63629-7166 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19720421 ANDA ANDA080352 Bryant Ranch Prepack PREDNISONE 5 mg/1 N 20191231 63629-7167_2370bc06-64e7-4c4c-aae7-178054cd62c8 63629-7167 HUMAN PRESCRIPTION DRUG Timolol Maleate timolol maleate TABLET ORAL 19900608 ANDA ANDA072668 Bryant Ranch Prepack TIMOLOL MALEATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-7169_de3f4cd3-b125-4e34-917d-1e1bd35fff98 63629-7169 HUMAN PRESCRIPTION DRUG Theophylline Anhydrous Theophylline TABLET, EXTENDED RELEASE ORAL 20120202 ANDA ANDA087571 Bryant Ranch Prepack THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 63629-7171_372fbc9c-19c4-4978-a428-af6b9acf0f48 63629-7171 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 Bryant Ranch Prepack INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 63629-7175_4a695f89-0743-4cd9-8a14-e709fcb6c2bd 63629-7175 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Bryant Ranch Prepack HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 63629-7176_c04039e6-f053-4aac-8eb6-7e4a9e9fee34 63629-7176 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090225 NDA AUTHORIZED GENERIC NDA018553 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63629-7178_108bbdbe-93a1-4ebb-9d3c-c73095566331 63629-7178 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19841107 ANDA ANDA062396 Bryant Ranch Prepack DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 63629-7193_4e80b2b7-0d24-44dd-828f-88b3299a6169 63629-7193 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20140320 ANDA ANDA090860 Bryant Ranch Prepack NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 63629-7194_dea5e36f-eab4-43a3-b9f5-cb858e6c73d9 63629-7194 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET ORAL 20130419 ANDA ANDA203145 Bryant Ranch Prepack VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 63629-7207_c65f10db-c8bc-4850-81cf-9657fb0babbc 63629-7207 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20130415 ANDA ANDA202675 Bryant Ranch Prepack GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 63629-7210_15801027-3bd4-4f63-b4be-d8a6e3b9a213 63629-7210 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20151026 ANDA ANDA203179 Bryant Ranch Prepack CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 63629-7213_6f587f1d-90bd-4ff9-8da0-003f9be506bb 63629-7213 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160209 NDA AUTHORIZED GENERIC NDA021656 Bryant Ranch Prepack FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 63629-7214_ea8d5e0d-d757-4d8b-81ae-65f34f4fe890 63629-7214 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Bryant Ranch Prepack NEFAZODONE HYDROCHLORIDE 250 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63629-7215_0acbedd9-01f7-41d7-8d8c-f3612d613cbc 63629-7215 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 19900920 ANDA ANDA072556 Bryant Ranch Prepack NIFEDIPINE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63629-7230_14d522f4-e236-4037-b351-232a79c79851 63629-7230 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20150206 ANDA ANDA203867 Bryant Ranch Prepack TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63629-7231_5c817e8c-7ac0-4ba0-95f2-d0a8d29a851c 63629-7231 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20101115 ANDA ANDA090421 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63629-7232_882801b9-87da-4ac5-91d1-6bd3e009102a 63629-7232 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63629-7233_ad6d6c23-95e7-4307-a76d-c9800a0f271e 63629-7233 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19981125 NDA NDA020943 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63629-7241_50e1503b-cd3c-4581-a1bb-287c2fcb6f61 63629-7241 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20070330 ANDA ANDA040646 Bryant Ranch Prepack HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63629-7248_225ed1b0-738c-4a4e-8ab5-047a992c65a9 63629-7248 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 Bryant Ranch Prepack GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63629-7249_225ed1b0-738c-4a4e-8ab5-047a992c65a9 63629-7249 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20051028 ANDA ANDA077270 Bryant Ranch Prepack GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 63629-7252_8b7bd3e7-8530-45e2-af38-bda302417cdb 63629-7252 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 19981231 ANDA ANDA040226 Bryant Ranch Prepack PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 63629-7260_e583f2ee-3dbe-4322-b88e-36f6a4e5f3d7 63629-7260 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Bryant Ranch Prepack RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-7266_397229c2-d757-49f2-afdb-e73bf73acd09 63629-7266 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 19970819 ANDA ANDA085588 Bryant Ranch Prepack PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 63629-7267_af570111-7ea8-416a-a3d4-7404b3a7de52 63629-7267 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA091079 Bryant Ranch Prepack OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63629-7270_11116957-d16a-4370-91b3-008662afffbe 63629-7270 HUMAN PRESCRIPTION DRUG Buprenorphine and Naloxone buprenorphine hydrochloride and naloxone hydrochloride TABLET SUBLINGUAL 20160107 ANDA ANDA204431 Bryant Ranch Prepack BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20191231 63629-7273_1d439588-db0c-4c65-b128-25391232d019 63629-7273 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Bryant Ranch Prepack SILDENAFIL CITRATE 25 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 63629-7275_88a66c15-1d47-4bd1-b4ca-3546e3a10578 63629-7275 HUMAN PRESCRIPTION DRUG Ivermectin Ivermectin TABLET ORAL 20141115 ANDA ANDA204154 Bryant Ranch Prepack IVERMECTIN 3 mg/1 Antiparasitic [EPC],Pediculicide [EPC] N 20181231 63629-7277_edf8ca22-d29f-43e4-b341-9b16eca71615 63629-7277 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161114 ANDA ANDA202557 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 7.5 mg/1 N 20181231 63629-7278_ec891f82-b181-4fe2-be6c-0d8a7bbdb017 63629-7278 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170424 ANDA ANDA200532 Bryant Ranch Prepack OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-7282_dea5e36f-eab4-43a3-b9f5-cb858e6c73d9 63629-7282 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 Bryant Ranch Prepack VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 63629-7287_1d45ca0f-1465-4473-9740-a65cc72fabe5 63629-7287 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19990503 ANDA ANDA071196 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63629-7293_b036a999-8e67-4c36-ae6c-c08944f9d5b8 63629-7293 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril TABLET ORAL 20160616 ANDA ANDA077222 Bryant Ranch Prepack FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-7300_f1283795-7a71-4d85-b0b8-a8097a93d866 63629-7300 HUMAN PRESCRIPTION DRUG Amiodarone hydrochloride Amiodarone hydrochloride TABLET ORAL 20090810 ANDA ANDA079029 Bryant Ranch Prepack AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 63629-7301_dea5e36f-eab4-43a3-b9f5-cb858e6c73d9 63629-7301 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 Bryant Ranch Prepack VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 63629-7305_5cc3aaf4-4076-44d7-b13d-b4a2ef5e5770 63629-7305 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 Bryant Ranch Prepack GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-7306_b5900d22-e495-4567-912b-45395f52b6f2 63629-7306 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Bryant Ranch Prepack GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-7307_83186290-2046-4ee9-a1af-38bed89ecfa3 63629-7307 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Bryant Ranch Prepack GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-7308_d6fd3196-8f03-44ae-b1a9-6fba4fd5e9e8 63629-7308 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Bryant Ranch Prepack GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-7309_5cc3aaf4-4076-44d7-b13d-b4a2ef5e5770 63629-7309 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 Bryant Ranch Prepack GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63629-7310_ea8d5e0d-d757-4d8b-81ae-65f34f4fe890 63629-7310 HUMAN PRESCRIPTION DRUG Nefazodone Hydrochloride Nefazodone Hydrochloride TABLET ORAL 20030916 ANDA ANDA076037 Bryant Ranch Prepack NEFAZODONE HYDROCHLORIDE 200 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 63629-7311_ca53b549-e196-4583-ae81-55e9a08aa746 63629-7311 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol Capsules 0.5 mcg CAPSULE ORAL 20141212 ANDA ANDA091356 Bryant Ranch Prepack CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 63629-7315_d70e6f58-be9b-4e9c-a572-5797de9e3f87 63629-7315 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120927 ANDA ANDA202566 Bryant Ranch Prepack MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 63629-7316_6f587f1d-90bd-4ff9-8da0-003f9be506bb 63629-7316 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160209 NDA AUTHORIZED GENERIC NDA021656 Bryant Ranch Prepack FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 63629-7319_8c5205b9-8397-447e-b431-6c9b362a64f1 63629-7319 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20010726 ANDA ANDA089452 Bryant Ranch Prepack PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 63629-7321_5e458421-110f-47a0-a959-fcaf65f2a101 63629-7321 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075511 Bryant Ranch Prepack FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 63629-7323_ca53b549-e196-4583-ae81-55e9a08aa746 63629-7323 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol Capsules 0.25 mcg CAPSULE ORAL 20141212 ANDA ANDA091356 Bryant Ranch Prepack CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 63629-7328_73185ed7-c92a-43b0-b999-015b1936595e 63629-7328 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071322 Bryant Ranch Prepack DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63629-7329_1e0ff2e2-e4e3-4948-b75c-dea831d6751b 63629-7329 HUMAN PRESCRIPTION DRUG Alendronate ALENDRONATE SODIUM TABLET ORAL 20150930 ANDA ANDA090258 Bryant Ranch Prepack ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 63629-7330_9e035abe-de5d-414b-8137-a7755f243b3c 63629-7330 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63629-7331_7f451b4f-9706-464a-8237-d8faea6ae8a1 63629-7331 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20151015 ANDA ANDA202870 Bryant Ranch Prepack METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-7332_7f451b4f-9706-464a-8237-d8faea6ae8a1 63629-7332 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate and Hydrochlorothiazide Metoprolol Tartrate and Hydrochlorothiazide TABLET ORAL 20151015 ANDA ANDA202870 Bryant Ranch Prepack METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-7333_ecc37f57-3865-4b7a-a4e3-44331f4e2d55 63629-7333 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20150827 ANDA ANDA206528 Bryant Ranch Prepack MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 63629-7335_04dfdc0c-94b1-4568-9c8f-c2ec905bc7b4 63629-7335 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 Bryant Ranch Prepack PREDNISONE 20 mg/1 N 20181231 63629-7339_320c3396-931a-4477-9581-37179541f780 63629-7339 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20160920 ANDA ANDA200900 Bryant Ranch Prepack PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 63629-7384_3994aae2-57b6-4039-8858-6e1025b6cdcc 63629-7384 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Bryant Ranch Prepack PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 63629-7388_b20178d1-a43e-4888-afa0-d2abdd9c850a 63629-7388 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 Bryant Ranch Prepack PREDNISONE 10 mg/1 N 20181231 63629-7390_571ac9f9-092c-46ac-899a-16c132214311 63629-7390 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161129 NDA AUTHORIZED GENERIC NDA021875 Bryant Ranch Prepack ARMODAFINIL 150 mg/1 CIV N 20191231 63629-7394_d9576bd3-4377-4e63-b05f-343513a5843d 63629-7394 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130403 ANDA ANDA076715 Bryant Ranch Prepack MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 63629-7397_9f48dec0-3e15-4c4c-8be6-4d0daec21af7 63629-7397 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride memantine hydrochloride TABLET, FILM COATED ORAL 20151101 ANDA ANDA200022 Bryant Ranch Prepack MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 63629-7399_bc993626-e435-47ee-8349-902a33e37cb7 63629-7399 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 63629-7403_571ac9f9-092c-46ac-899a-16c132214311 63629-7403 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161129 NDA AUTHORIZED GENERIC NDA021875 Bryant Ranch Prepack ARMODAFINIL 250 mg/1 CIV N 20191231 63629-7413_13bea2a5-3121-4379-8053-f011b0cacc46 63629-7413 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20170612 ANDA ANDA203931 Bryant Ranch Prepack EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 63629-7421_834d5ea8-a23f-4039-a746-42348d708816 63629-7421 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20130902 ANDA ANDA078155 Bryant Ranch Prepack SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 63629-7422_a44b8396-3b54-4bf6-99cc-6eb5ed7f77a1 63629-7422 HUMAN PRESCRIPTION DRUG Colchicine Colchicine CAPSULE ORAL 20141001 NDA NDA204820 Bryant Ranch Prepack COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20181231 63629-7423_ddecc505-bcd7-4617-9593-1ac513925724 63629-7423 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone TABLET ORAL 20170707 ANDA ANDA207029 Bryant Ranch Prepack HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63629-7424_1ac247d3-21a8-4159-854c-7f13d1cd1085 63629-7424 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20130307 ANDA ANDA040148 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 63629-7432_f98cc1dd-4b45-4470-9874-239c7b783661 63629-7432 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160829 ANDA ANDA202696 Bryant Ranch Prepack VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 63629-7433_bb1b7f87-2ae6-4a15-81f0-dc60a4cacdaa 63629-7433 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20160722 ANDA ANDA204339 Bryant Ranch Prepack RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 63629-7440_8104a113-54f4-4b0b-9f16-86cdaa99d112 63629-7440 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20151015 NDA AUTHORIZED GENERIC NDA018225 Bryant Ranch Prepack BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63629-7445_b609ed5d-0dcb-4722-9bd2-35af63b34973 63629-7445 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20130213 ANDA ANDA076063 Bryant Ranch Prepack LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 63629-7468_c6311cd8-3303-476b-904e-d8cc877493a3 63629-7468 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120927 ANDA ANDA202414 Bryant Ranch Prepack IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 63629-7475_4eebf7fd-fa2f-4678-98d2-585c78d5b6a2 63629-7475 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20160713 NDA NDA019781 Bryant Ranch Prepack PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 63629-7477_48d78a2b-146d-4bf1-bbf0-924497fc09c5 63629-7477 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 63629-7483_3bdbedbd-6666-457e-827e-8901ef894908 63629-7483 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Bryant Ranch Prepack NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 63645-111_33e3f014-ea35-4b27-b1cc-59fc0cff2caa 63645-111 HUMAN OTC DRUG OraLabs ChapIce Cherry SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20000103 OTC MONOGRAPH NOT FINAL part352 OraLabs PADIMATE O; PETROLATUM 15; 440 mg/g; mg/g N 20181231 63645-128_f0ad0966-6c61-4350-918a-282c10e9c9ef 63645-128 HUMAN OTC DRUG USANA Lip Moisturizer Avobenzone, Octinoxate, Octisalate LIPSTICK TOPICAL 20120706 OTC MONOGRAPH NOT FINAL part352 Oralabs AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/1; g/1; g/1 N 20181231 63645-130_6ae352fa-3d4b-4720-b68b-f58b690a501f 63645-130 HUMAN OTC DRUG ChapIce Original SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 OraLabs PETROLATUM; PADIMATE O 44; 1.5 mg/g; mg/g N 20181231 63645-140_1fcc1d6e-71b8-4f2f-8794-b3d013ad4ea7 63645-140 HUMAN OTC DRUG ChapIce Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part352 OraLabs OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g N 20181231 63645-160_a0f07fe2-63e7-4908-ac4f-7c25d396738b 63645-160 HUMAN OTC DRUG ChapIce Camphor Phenol Gel Camphor, Phenol GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part346 OraLabs CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 mg/g; mg/g N 20181231 63645-161_68b9836e-85f7-4f1f-8312-d15f991c20e6 63645-161 HUMAN OTC DRUG ChapIce Medicated Balm Camphor, Menthol GEL TOPICAL 20130315 OTC MONOGRAPH FINAL part346 OraLabs CAMPHOR (SYNTHETIC); MENTHOL 1.7; .7 mg/g; mg/g N 20181231 63645-162_792873ae-b15a-408e-92d0-e8bf1e6fc8f1 63645-162 HUMAN OTC DRUG OraLabs Cold Sore Treatment Benzocaine OINTMENT TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part348 OraLabs BENZOCAINE 5 mg/g N 20181231 63645-163_49a00692-1577-4f74-9c64-73ac9791e63f 63645-163 HUMAN OTC DRUG ChapIce SPF 30 Lip Balm Octinoxate, Octocrylene, Oxybenzone, Octisalate STICK TOPICAL 20171009 OTC MONOGRAPH NOT FINAL part352 OraLabs OCTINOXATE; OXYBENZONE; OCTOCRYLENE; OCTISALATE 7.5; 5; 10; 5 mg/g; mg/g; mg/g; mg/g N 20181231 63645-164_ecb2cfda-d5f1-4bb3-aa1c-b9ac933e26d7 63645-164 HUMAN OTC DRUG ChapIce SPF 30 Lip Balm Octinoxate, Octocrylene, Oxybenzone, Octisalate STICK TOPICAL 20171009 OTC MONOGRAPH NOT FINAL part352 OraLabs OCTINOXATE; OXYBENZONE; OCTOCRYLENE; OCTISALATE 7.5; 5; 10; 5 mg/g; mg/g; mg/g; mg/g N 20181231 63645-165_61299626-bf60-40e8-a2d3-4d4a99d8d15c 63645-165 HUMAN OTC DRUG Sunfrog Ultra SPF 30 Lip Balm Octinoxate, Octocrylene, Oxybenzone, Octisalate, Petroleum Jelly STICK TOPICAL 20171129 OTC MONOGRAPH NOT FINAL part352 OraLabs OCTINOXATE; OXYBENZONE; PETROLATUM; OCTOCRYLENE; OCTISALATE 7.5; 5; 30; 7; 5 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 63646-010_10974332-6e85-435a-96aa-862bddcdaa74 63646-010 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20161001 ANDA ANDA076942 TOLMAR Inc. KETOCONAZOLE 20.5 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 63646-020_1b45c2ce-e210-4c16-9d0e-8061977c53a8 63646-020 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090115 ANDA ANDA079107 TOLMAR Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63646-191_124ae8cd-be01-45f0-89e7-7609ec816b2e 63646-191 HUMAN PRESCRIPTION DRUG ATRIDOX Doxycycline Hyclate KIT ORAL 19980903 NDA NDA050751 TOLMAR Inc. N 20181231 63646-300_5faa0e7e-ff73-4a0d-821c-0c4ed473dbbf 63646-300 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir OINTMENT TOPICAL 20170818 ANDA ANDA206437 TOLMAR Inc. ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 63646-500_00cd9462-601e-4e2d-b1fe-7feeca2a3f98 63646-500 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate SOLUTION TOPICAL 20170208 ANDA ANDA076977 TOLMAR Inc. CLOBETASOL PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63653-1171_e6b61b2c-2f5e-410f-a940-9988d1e0a443 63653-1171 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 19971117 NDA NDA020839 Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 63653-1332_e6b61b2c-2f5e-410f-a940-9988d1e0a443 63653-1332 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 20090509 NDA NDA020839 Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 63654-275_a20f4552-1c1c-4d10-96a2-cb23cbf1514c 63654-275 HUMAN OTC DRUG Cold Medicine Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20111115 OTC MONOGRAPH FINAL part341 Selder, S.A. de C.V. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 63654-309_64ec1b37-e0ba-4683-982c-f09b6ed640d4 63654-309 HUMAN OTC DRUG Allergy Loratadine TABLET ORAL 20141216 ANDA ANDA076471 Selder, S.A. de C.V. LORATADINE 10 mg/1 N 20181231 63654-345_49606e7f-cfec-40ef-a1de-5885d805ee3f 63654-345 HUMAN OTC DRUG Mucus Relief Guaifensin, Dextromethorphan TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Selder, S.A. de C.V. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 63654-380_86d1973f-2249-4a8a-bb1a-a41f7fb8e26b 63654-380 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20170517 ANDA ANDA208150 Selder, S.A. de C.V. FLUTICASONE PROPIONATE 50 ug/1 N 20181231 63654-500_132086cf-8509-4e69-b2f7-4a3e1f462a09 63654-500 HUMAN OTC DRUG XL-DOL acetaminophen TABLET ORAL 20111115 OTC MONOGRAPH NOT FINAL part343 Selder, S.A. de C.V. ACETAMINOPHEN 500 mg/1 E 20171231 63654-600_09cc48f3-e043-4da8-a9f1-00cb6ccbee95 63654-600 HUMAN OTC DRUG Cold Medicine XL3 Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride TABLET ORAL 20111115 OTC MONOGRAPH FINAL part341 Selder, S.A. de C.V. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 4; 10 mg/1; mg/1; mg/1 E 20171231 63654-601_64920911-ee76-3973-e053-2a91aa0a5343 63654-601 HUMAN OTC DRUG Cold Medicine XL3 FORTE Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride TABLET ORAL 20170801 OTC MONOGRAPH FINAL part341 Selder, S.A. de C.V. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 4; 10 mg/1; mg/1; mg/1 N 20191231 63654-700_48463aac-5d95-43fa-a623-510c40c15d7b 63654-700 HUMAN OTC DRUG Cold Medicine XL-3 for Children Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride TABLET, CHEWABLE ORAL 20111115 OTC MONOGRAPH FINAL part341 Selder, S.A. de C.V. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 80; 2; 5 mg/1; mg/1; mg/1 E 20171231 63654-800_664add4d-d3f8-4c7c-9784-7b08be2b143f 63654-800 HUMAN OTC DRUG Cough and Cold XL3 Xtra Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20111115 OTC MONOGRAPH FINAL part341 Selder, S.A. de C.V. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 250; 5; 2; 10 mg/1; mg/1; mg/1; mg/1 N 20181231 63667-185_1663333b-9175-4cdc-a989-924513d85675 63667-185 HUMAN OTC DRUG MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL LOZENGE ORAL 20150901 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 4.8 mg/1 N 20181231 63667-224_200734eb-a6bd-45b7-a817-07e19160cd82 63667-224 HUMAN OTC DRUG DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL LOZENGE ORAL 20110403 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 8.3 mg/1 N 20181231 63667-234_07f46d88-1092-42a5-b4a8-332c2c0d3880 63667-234 HUMAN OTC DRUG DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL LOZENGE ORAL 20150501 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 8.3 mg/1 N 20181231 63667-242_d7efcc21-ec99-48c6-a7a3-524de621cfe5 63667-242 HUMAN OTC DRUG DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL LOZENGE ORAL 20110403 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 8.5 mg/1 N 20181231 63667-503_f91d4686-9433-4aec-809d-83c05901e716 63667-503 HUMAN OTC DRUG EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL LOZENGE ORAL 20130527 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 8.3 mg/1 N 20181231 63667-507_d66bafa5-b8fa-4139-8d37-88d510fd9304 63667-507 HUMAN OTC DRUG Natural Cherry Honey Herb Throat Drops MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 1.8 mg/1 N 20181231 63667-676_f08dff3b-6de5-428a-9bd1-7c7fe23e52d6 63667-676 HUMAN OTC DRUG NATURAL LEMON MINT HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 1.6 mg/1 N 20181231 63667-923_cde441dd-f2c8-45ec-9239-978c2a9537bf 63667-923 HUMAN OTC DRUG THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 5.3 mg/1 N 20181231 63667-953_68f1511f-5ac0-416a-92d7-1195cd40d661 63667-953 HUMAN OTC DRUG Natural Cherry Honey Herb Throat Drops MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 2 mg/1 N 20181231 63667-954_d01d19c6-68a0-4161-b800-fe7323846c73 63667-954 HUMAN OTC DRUG NATURAL HONEY HERB COUGH SUPPRESSANT THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 2 mg/1 N 20181231 63667-955_fa7b6b3f-d6a1-4666-a421-9c10f1a7961b 63667-955 HUMAN OTC DRUG THE ORIGINAL NATURAL HERB COUGH DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 4.8 mg/1 N 20181231 63667-956_718a405a-af66-43ee-bd3f-232db79c4cb6 63667-956 HUMAN OTC DRUG SUGAR FREE LEMON MINT HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 1.1 mg/1 N 20181231 63667-957_37b1b9ba-6b93-4774-9745-1c68bcaad0d7 63667-957 HUMAN OTC DRUG NATURAL LEMON MINT HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 1.5 mg/1 N 20181231 63667-958_5714f20e-51e3-47b4-8473-786acc1f89a7 63667-958 HUMAN OTC DRUG Sugar Free Mountain Herb Cough Suppressant Throat Drops MENTHOL LOZENGE ORAL 19420412 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 4.8 mg/1 N 20181231 63667-960_8e54fdd6-38b0-4d66-aa22-aa27d5befa66 63667-960 HUMAN OTC DRUG Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 3.5 mg/1 N 20181231 63667-971_7623a5de-3e5e-4ae1-9959-861d57802ab3 63667-971 HUMAN OTC DRUG SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH FINAL part341 Ricola USA Inc. MENTHOL 4.1 mg/1 N 20191231 63667-976_39cbea41-48ba-453f-96dc-258643b6fadb 63667-976 HUMAN OTC DRUG SUGAR FREE SWISS CHERRY HERB THROAT DROPS MENTHOL LOZENGE ORAL 19420101 OTC MONOGRAPH NOT FINAL part356 Ricola USA Inc. MENTHOL 2.2 mg/1 N 20181231 63672-0005_65ee30e3-b0ed-4150-b590-95387ed3a991 63672-0005 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20090706 ANDA ANDA077973 Synthon Pharmaceuticals, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] E 20171231 63672-0015_5debd92c-9b60-475d-bf8b-b8cae30e43c6 63672-0015 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20100628 ANDA ANDA078322 Synthon Pharmaceuticals, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 63672-0021_e4c3c963-977b-4772-99d5-3b930a4aae41 63672-0021 HUMAN PRESCRIPTION DRUG tamsulosin hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 Synthon Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 63672-0051_c1f4c652-5aa3-4f4f-a201-9d540a058557 63672-0051 HUMAN PRESCRIPTION DRUG Levocetirizine dihydrochloride Levocetirizine dihydrochloride TABLET, FILM COATED ORAL 20101126 ANDA ANDA090229 Synthon Pharmaceuticals, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 63674-001_61e41c3f-b765-4b3d-e053-2991aa0a3248 63674-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000110 UNAPPROVED MEDICAL GAS Uintah Basin Medical Center dba Home Health Equipment and Supply OXYGEN 99 L/100L N 20191231 63687-0001_6e294ef0-e6b9-41ef-ab6b-377113f818fb 63687-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000201 UNAPPROVED MEDICAL GAS EME Medical Equipment (Ephrata Medical Equip.) OXYGEN 99 L/100L E 20171231 63691-002_ba113747-7e63-40d0-9ba9-7366c296755d 63691-002 HUMAN OTC DRUG Antibacterial Triclosan SOAP TOPICAL 19980213 OTC MONOGRAPH NOT FINAL part333A Sun Products Corporation TRICLOSAN .1 mL/100mL E 20171231 63691-009_a6cce003-e881-4954-9a8c-1f8681b542d9 63691-009 HUMAN OTC DRUG Our Family Dish and Antibacterial Citrus Burst Scent Triclosan SOAP TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-010_27967330-80ae-3ea0-e054-00144ff8d46c 63691-010 HUMAN OTC DRUG Safeway Home Orange Scent Triclosan SOAP TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-011_7cf76aa8-7614-48e3-8734-235b16871338 63691-011 HUMAN OTC DRUG Wegmans Ultra Dishwashing Orange Scent Triclosan SOAP TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-012_684b29f5-8d38-4911-8b14-f52cdb60a43e 63691-012 HUMAN OTC DRUG Safeway Home Lemon Scent Triclosan SOAP TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-013_0c8df5d7-7bcb-42b6-80f9-78f0105e62b0 63691-013 HUMAN OTC DRUG Home 360 Ultra Dish Detergent Green Apple Scent Triclosan SOAP TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-014_4b44f624-844d-4a60-8e21-3aad740726a3 63691-014 HUMAN OTC DRUG Publix UltraDish Detergent Triclosan SOAP TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-016_00aa6fa8-9db2-4cac-a4e4-bdede3f7bb8d 63691-016 HUMAN OTC DRUG Publix UltraDish Detergent Green Apple Scent Triclosan SOAP TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-019_21b1f8fe-028e-6131-e054-00144ff88e88 63691-019 HUMAN OTC DRUG Up (and) Up Green Apple Scent Triclosan SOAP TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-020_21b1f8fe-023e-6131-e054-00144ff88e88 63691-020 HUMAN OTC DRUG Reeva Antibacterial Green Apple Triclosan SOAP TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-021_254ff13b-6065-479b-a46f-849426ff71d0 63691-021 HUMAN OTC DRUG Shop Rite Ultra So-soft Triclosan SOAP TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-022_17a4893b-4d0a-45c5-b7ed-5bb93393da8a 63691-022 HUMAN OTC DRUG My Essentials Citrus Scent Triclosan SOAP TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-023_36a8956a-9fc9-48ff-bd14-769601b57bdb 63691-023 HUMAN OTC DRUG Market Basket Ultra Triclosan SOAP TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-024_2248150c-64d2-49ce-a10d-a8c2f85e8f46 63691-024 HUMAN OTC DRUG Exchange Select Ultra Citrus Scent Triclosan SOAP TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-025_d0bc08db-46ac-446e-be0c-bbcd164aa4ad 63691-025 HUMAN OTC DRUG Essential Everyday Orange Scent Triclosan SOAP TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-026_bb1dadb1-8758-4608-9a79-3aa207ba0ce3 63691-026 HUMAN OTC DRUG Wegmans Orange Scent Triclosan SOAP TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation TRICLOSAN .1 g/100mL E 20171231 63691-027_367183cb-ccab-38c8-e054-00144ff88e88 63691-027 HUMAN OTC DRUG Signature Home AB Orange Chloroxylenol SOAP TOPICAL 20160430 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation CHLOROXYLENOL .3 g/100mL N 20181231 63691-028_36740989-3e37-0f86-e054-00144ff88e88 63691-028 HUMAN OTC DRUG Ultra So-Soft Dish Detergent Chloroxylenol SOAP TOPICAL 20160430 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation CHLOROXYLENOL .3 g/100mL N 20181231 63691-029_3680e9c4-c93f-60a6-e054-00144ff88e88 63691-029 HUMAN OTC DRUG Up (and) Up Green Apple Scent Chloroxylenol SOAP TOPICAL 20151130 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation CHLOROXYLENOL .3 g/100mL N 20181231 63691-030_3681478e-1e6b-3ed2-e054-00144ff8d46c 63691-030 HUMAN OTC DRUG Essential Everyday Dishwashing Liquid Orange Chloroxylenol SOAP TOPICAL 20160430 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation CHLOROXYLENOL .3 g/100mL N 20181231 63691-031_36820434-8f0a-0d3d-e054-00144ff88e88 63691-031 HUMAN OTC DRUG Publix Green Apple Scent Chloroxylenol SOAP TOPICAL 20160430 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation CHLOROXYLENOL .3 g/100mL N 20181231 63691-032_3684470e-cdd0-52f2-e054-00144ff88e88 63691-032 HUMAN OTC DRUG Publix Ultra Dish Detergent Orange Chloroxylenol SOAP TOPICAL 20160430 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation CHLOROXYLENOL .3 g/100mL N 20181231 63691-033_4a291344-2d2b-2791-e054-00144ff8d46c 63691-033 HUMAN OTC DRUG Great Value Orange Scent Orange Chloroxylenol SOAP TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation CHLOROXYLENOL .3 g/100mL N 20181231 63691-034_4a2a28d2-7145-595b-e054-00144ff8d46c 63691-034 HUMAN OTC DRUG Great Value Green Apple Scent Chloroxylenol Green Apple SOAP TOPICAL 20161230 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation CHLOROXYLENOL .3 g/100mL N 20181231 63691-035_4a9f83c5-d95c-5fee-e054-00144ff88e88 63691-035 HUMAN OTC DRUG Wegmans Ultra Dishwashing Liquid Orange Scent Dishwashing Liquid Orange Scent SOAP TOPICAL 20161031 OTC MONOGRAPH NOT FINAL part333E Sun Products Corporation CHLOROXYLENOL .3 g/100mL N 20181231 63699-001_f7edf9f6-c3ac-4b15-b448-c919f102991b 63699-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20120831 UNAPPROVED MEDICAL GAS Ablecare Medical, Inc. OXYGEN 99 L/100L E 20171231 63701-123_60c70d70-a9f4-7644-e053-2a91aa0a7cf6 63701-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20170112 UNAPPROVED MEDICAL GAS MTB Oxygen & Equipment Company of Toledo OXYGEN 99 L/100L N 20181231 63704-004_fcc24d99-0809-4e43-9559-22575ed30424 63704-004 HUMAN PRESCRIPTION DRUG METHYLERGONOVINE MALEATE methylergonovine maleate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20101101 ANDA ANDA040889 Pharmacist Pharmaceutical, LLC METHYLERGONOVINE MALEATE .2 mg/mL Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 63704-006_84d562e7-4ac9-43d5-bcd6-af370975c027 63704-006 HUMAN PRESCRIPTION DRUG methylergonovine maleate methylergonovine maleate TABLET ORAL 20110801 ANDA ANDA091577 Pharmacist Pharmaceutical, LLC METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] E 20171231 63704-008_7e01739f-e7de-4a13-8300-e8a5ed8e54a8 63704-008 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20130412 ANDA ANDA091667 Pharmacist Pharmaceutical, LLC MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 63704-009_f9c3c141-3ac1-4e8c-ac2d-e57fac0be7a3 63704-009 HUMAN PRESCRIPTION DRUG Levonorgestrel Levonorgestrel TABLET ORAL 20130611 ANDA ANDA202508 Pharmacist Pharmaceutical, LLC LEVONORGESTREL 1.5 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] E 20171231 63704-010_840a68ff-8ee6-42d1-b371-6310093ec565 63704-010 HUMAN OTC DRUG Levonorgestrel Levonorgestrel TABLET ORAL 20140312 ANDA ANDA202508 Pharmacist Pharmaceutical, LLC LEVONORGESTREL 1.5 mg/1 E 20171231 63712-123_1e162f4e-34d5-4dc4-8a90-e1c402193afe 63712-123 HUMAN OTC DRUG DAILY DEFENCE SUNSCREEN Broad Spectrum SPF30 Octinoxate, Octisalate, Avobenzone, and Octocrylene CREAM TOPICAL 20140602 OTC MONOGRAPH NOT FINAL part352 ZELENS Limited OCTINOXATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 74; 50; 30; 27 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63712-201_ae79c3eb-b061-4b3c-81a4-b11c96070272 63712-201 HUMAN OTC DRUG BODY DEFENCE SUNSCREEN Broad Spectrum SPF30 Octinoxate, Octisalate, Homosalate, Avobenzone, and Octocrylene OIL TOPICAL 20160501 OTC MONOGRAPH FINAL part352 ZELENS Limited OCTINOXATE; OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE 75; 50; 50; 30; 27.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63713-050_3a2e4b22-76e0-4406-8cd8-d67d595867a7 63713-050 PLASMA DERIVATIVE EVARREST Fibrinogen Human and Human Thrombin PATCH TOPICAL 20130301 BLA BLA125392 Ethicon, Inc. FIBRINOGEN HUMAN; HUMAN THROMBIN 8.6; 37.5 mg/cm2; [iU]/cm2 Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 63713-390_01d0eb5b-e9e2-4eaa-af09-501f37adcee5 63713-390 PLASMA DERIVATIVE EVICEL Fibrin Sealant (Human) Fibrinogen Human and Thrombin Human KIT 20130321 BLA BLA125010 Ethicon Inc N 20181231 63713-390_397f25e5-a574-44fd-89fc-27d85ad27bb2 63713-390 PLASMA DERIVATIVE EVICEL Fibrin Sealant (Human) Fibrinogen Human and Thrombin Human KIT 20130321 BLA BLA125010 Ethicon Inc N 20181231 63713-390_8561d9f0-468d-47ea-bedc-ab6b9c110ded 63713-390 PLASMA DERIVATIVE EVICEL Fibrin Sealant (Human) Fibrinogen Human and Thrombin Human KIT 20130321 BLA BLA125010 Ethicon Inc N 20181231 63713-460_1d71e5b0-de7d-4eae-927b-d2781aa4454f 63713-460 PLASMA DERIVATIVE EVITHROM Human Thrombin LIQUID TOPICAL 20071027 BLA BLA125247 Ethicon Inc HUMAN THROMBIN 1000 [iU]/mL Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] E 20171231 63713-461_e7cd5a63-565e-404c-9122-5f65c358f30e 63713-461 PLASMA DERIVATIVE thrombin human thrombin human POWDER, FOR SOLUTION TOPICAL 20090919 BLA BLA125247 Ethicon, Inc HUMAN THROMBIN 2000 [iU]/2mL Human Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 63717-876_e1431717-782c-4893-bf49-8e4c80713318 63717-876 HUMAN PRESCRIPTION DRUG ZUTRIPRO hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride SOLUTION ORAL 20110608 NDA NDA022439 Hawthorn Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE 5; 60; 4 mg/5mL; mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CII N 20181231 63730-171_cd3db22a-7bd2-4a6e-bced-6f11c938634b 63730-171 HUMAN OTC DRUG The Cure Sheer Cream Octinoxate, Titanium Dioxide CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International OCTINOXATE; TITANIUM DIOXIDE 2; 4 mL/50mL; g/50mL E 20171231 63730-204_ed12b13e-5d4a-4fa0-ac98-790347a98ed1 63730-204 HUMAN OTC DRUG Essential Shockeye and Lip Avobenzone, Homosalate, Octinocate, Octocrylene, Oxybenzone CREAM TOPICAL 20100604 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International, S.A. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 454; 1.44; .6; .36; 151 mg/15mL; mL/15mL; mL/15mL; mL/15mL; mg/15mL E 20171231 63730-216_c2504171-ecca-4d8b-aa6a-f9df73bbfb78 63730-216 HUMAN OTC DRUG Tensolift Avobenzone, Homosalate, Octinoxate, Octyocrelene, Oxybenzone CREAM TOPICAL 20100607 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International, S.A. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 2.76; 8.76; 3.65; 2.19; 921 g/90mL; mL/90mL; mL/90mL; mL/90mL; mg/90mL E 20171231 63730-222_4afa4533-6921-4974-8b3c-b63533061088 63730-222 HUMAN OTC DRUG The Cure Oil-Free Octinoxate, Titanium Dioxide CREAM TOPICAL 20140421 OTC MONOGRAPH FINAL part352 Natura Bisse International SA OCTINOXATE; TITANIUM DIOXIDE 2; 3 g/50g; g/50g E 20171231 63730-223_3cf7683d-48c3-46fc-e054-00144ff8d46c 63730-223 HUMAN OTC DRUG Diamond White Oil-Free Brilliant Sun Protection Ensulizole, Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International SA OCTINOXATE; ENSULIZOLE; ZINC OXIDE; TITANIUM DIOXIDE 2; 1; 2; 3 g/30g; g/30g; g/30g; g/30g E 20171231 63730-340_923e9252-a3b6-4d33-af6e-7fd0eb8d8395 63730-340 HUMAN OTC DRUG Macroantioxidant Sun Protection avobenzone, homosalate, octinoxate, octocrylene, oxybenzone CREAM TOPICAL 20150202 OTC MONOGRAPH FINAL part352 Natura Bisse International SA AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7.5; 10; 3 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 63730-364_e08d1d5a-4655-4af5-8a43-205a75f43355 63730-364 HUMAN OTC DRUG Dry Oil Antioxidant Sun Protection Avobenzone, Homosalate, Octinoxate, Octocrylene, Oxybenzone CREAM TOPICAL 20150130 OTC MONOGRAPH FINAL part352 Natura Bisse International SA AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3; 10; 4; 10; 5 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 63730-391_2e0932e9-d883-525a-e054-00144ff88e88 63730-391 HUMAN OTC DRUG S.O.S. INSTANT RESCUE DIMETHICONE GEL TOPICAL 20160229 OTC MONOGRAPH FINAL part347 NATURA BISSÉ INTERNATIONAL, S.A. DIMETHICONE 1 mg/100mg E 20171231 63730-392_4a366379-9a50-729a-e054-00144ff88e88 63730-392 HUMAN OTC DRUG The Cure Oil-Free Octinoxate, Titanium Dioxide CREAM TOPICAL 20170308 OTC MONOGRAPH FINAL part352 Natura Bisse International SA OCTINOXATE; TITANIUM DIOXIDE 2; 3 g/50g; g/50g N 20181231 63730-393_4a365b96-a416-67b7-e054-00144ff88e88 63730-393 HUMAN OTC DRUG Tensolift Avobenzone, Homosalate, Octinoxate, Octyocrelene, Oxybenzone CREAM TOPICAL 20100607 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International, S.A. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 2.76; 8.76; 3.65; 2.19; 921 g/90mL; mg/90mL; mg/90mL; mg/90mL; mg/90mL N 20181231 63730-394_4a366379-9a4d-729a-e054-00144ff88e88 63730-394 HUMAN OTC DRUG S.O.S. INSTANT RESCUE DIMETHICONE GEL TOPICAL 20170308 OTC MONOGRAPH FINAL part347 NATURA BISSÉ INTERNATIONAL, S.A. DIMETHICONE 1 mg/100mg N 20181231 63730-395_4a366379-9a3f-729a-e054-00144ff88e88 63730-395 HUMAN OTC DRUG Essential Shockeye and Lip Avobenzone, Homosalate, Octinocate, Octocrylene, Oxybenzone CREAM TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International, S.A. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 454; 1.44; .6; .36; 151 mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 63730-396_4a366379-9a37-729a-e054-00144ff88e88 63730-396 HUMAN OTC DRUG Diamond White Oil-Free Brilliant Sun Protection Ensulizole, Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International SA OCTINOXATE; ENSULIZOLE; ZINC OXIDE; TITANIUM DIOXIDE 2; 1; 2; 3 g/30g; g/30g; g/30g; g/30g N 20181231 63730-397_4a366379-9a2a-729a-e054-00144ff88e88 63730-397 HUMAN OTC DRUG Macroantioxidant Sun Protection avobenzone, homosalate, octinoxate, octocrylene, oxybenzone CREAM TOPICAL 20170308 OTC MONOGRAPH FINAL part352 Natura Bisse International SA AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3; 10; 7.5; 10; 3 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 63730-398_4a366379-9a1e-729a-e054-00144ff88e88 63730-398 HUMAN OTC DRUG Dry Oil Antioxidant Sun Protection Avobenzone, Homosalate, Octinoxate, Octocrylene, Oxybenzone CREAM TOPICAL 20170308 OTC MONOGRAPH FINAL part352 Natura Bisse International SA AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3; 10; 4; 10; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 63730-399_4a365b96-a40f-67b7-e054-00144ff88e88 63730-399 HUMAN OTC DRUG The Cure Sheer Cream Octinoxate, Titanium Dioxide CREAM TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Natura Bisse International OCTINOXATE; TITANIUM DIOXIDE 2; 4 mg/50mL; g/50mL N 20181231 63736-001_7dff99b6-bf15-475c-94db-331edee20da1 63736-001 HUMAN OTC DRUG Monistat 1 Combination Pack Triple Action Miconazole Nitrate KIT 20010629 NDA NDA021308 Insight Pharmaceuticals N 20181231 63736-002_d56633cc-333f-423b-b64b-e677e087291f 63736-002 HUMAN OTC DRUG Monistat 3 Combination Pack Triple Action Miconazole Nitrate KIT 19960416 NDA NDA020670 Insight Pharmaceuticals N 20181231 63736-003_0f0c66d5-e8df-4834-af66-38f7f3a9f5d7 63736-003 HUMAN OTC DRUG Monistat 7 Combination Pack Triple Action Miconazole Nitrate KIT 19930426 NDA NDA017450 Insight Pharmaceuticals N 20181231 63736-012_856ae077-f23b-40bf-9a06-09e6f0d56d19 63736-012 HUMAN OTC DRUG Kondremul Kondremul LIQUID ORAL 20090605 OTC MONOGRAPH FINAL part334 Insight Pharmaceuticals MINERAL OIL 2.5 mL/5mL E 20171231 63736-013_c4959afc-0e98-4da4-893b-5da6a0b65957 63736-013 HUMAN OTC DRUG Monistat 1 Combination Pack Miconazole Nitrate KIT 20010629 NDA NDA021308 Insight Pharmaceuticals N 20181231 63736-014_f4d0fb63-ff03-4d5a-9f11-2e04fbb0823b 63736-014 HUMAN OTC DRUG Monistat 1 Combination Pack Miconazole Nitrate KIT 20010629 NDA NDA021308 Insight Pharmaceuticals E 20171231 63736-015_b9874b2a-5c6e-4b87-a570-19804b7fc99b 63736-015 HUMAN OTC DRUG Monistat 3 3-Day Pre-filled Applicators Miconazole Nitrate CREAM VAGINAL 19980330 NDA NDA020827 Insight Pharmaceuticals MICONAZOLE NITRATE 40 mg/g N 20181231 63736-016_adba15db-7324-4621-be60-71a8b1f895df 63736-016 HUMAN OTC DRUG Monistat 3 Combination Pack Miconazole Nitrate KIT 19960416 NDA NDA020670 Insight Pharmaceuticals N 20181231 63736-018_d2d67e80-0b22-4ecd-b721-5d259e90fc3a 63736-018 HUMAN OTC DRUG Monistat 3 Combination Pack Miconazole Nitrate KIT 20091210 NDA NDA020670 Insight Pharmaceuticals E 20171231 63736-019_3489afb2-0cdf-4fd4-a5b8-4860bd3c9f51 63736-019 HUMAN OTC DRUG Monistat 3 Combination Pack 3 Ovule Inserts Miconazole Nitrate KIT 19960416 NDA NDA020670 Insight Pharmaceuticals N 20181231 63736-023_eaa9e15b-ff99-4f88-b5ce-e5851676731e 63736-023 HUMAN OTC DRUG Monistat 7 Combination Pack 7-Day Pre-Filled Applicators Miconazole Nitrate KIT 19930426 NDA NDA017450 Insight Pharmaceuticals E 20171231 63736-024_58c9864e-f28c-4ea3-988f-c2d21c108b47 63736-024 HUMAN OTC DRUG Nix Permethrin SHAMPOO TOPICAL 20090605 NDA NDA019918 Insight Pharmaceuticals PERMETHRIN 560 mg/59mL E 20171231 63736-024_5d596cc9-d8d0-4cc4-9b9d-cd303330e9b5 63736-024 HUMAN OTC DRUG Nix Permethrin SHAMPOO TOPICAL 20090605 NDA NDA019918 Insight Pharmaceuticals PERMETHRIN 560 mg/59mL E 20171231 63736-025_86e62d97-42cb-45b9-b634-db0e4a497fa7 63736-025 HUMAN OTC DRUG Monistat 7 with Reusable Applicator Miconazole Nitrate CREAM VAGINAL 19930426 NDA NDA017450 Insight Pharmaceuticals MICONAZOLE NITRATE 20 mg/g N 20181231 63736-026_f65a4c4d-ec1d-40de-a1f2-1786452fc218 63736-026 HUMAN OTC DRUG Monistat 7 7-Day Disposable Applicators Miconazole Nitrate CREAM VAGINAL 20100415 NDA NDA017450 Insight Pharmaceuticals MICONAZOLE NITRATE 20 mg/g N 20181231 63736-027_9feae582-d3e2-49e7-b9d5-a56f68dbae50 63736-027 HUMAN OTC DRUG Nix Complete Maximum Strength Lice Elimination Permethrin KIT 20131115 NDA NDA019918 Insight Pharmaceuticals E 20171231 63736-029_245c0edc-ed04-4ee9-9f04-cfc03fc36f6a 63736-029 HUMAN OTC DRUG Monistat Complete Care Instant Itch Relief hydrocortisone CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals HYDROCORTISONE 1 g/100g E 20171231 63736-031_ea1a4a6c-3814-4789-916f-f042d5db8958 63736-031 HUMAN OTC DRUG Monistat Complete Care Chafing Relief dimethicone GEL TOPICAL 20131115 OTC MONOGRAPH FINAL part347 Insight Pharmaceuticals DIMETHICONE 1.2 g/100g N 20181231 63736-041_3d1bdfc4-e7dc-45eb-b187-d7fde11d2ab4 63736-041 HUMAN OTC DRUG Boil Ease Benzocaine CREAM TOPICAL 20100621 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals BENZOCAINE 5 g/28g E 20171231 63736-044_f119f7a7-c1a8-44a6-a678-0e13c46294fd 63736-044 HUMAN OTC DRUG Bonine Kids Chlorcyclizine Hydrochloride TABLET, CHEWABLE ORAL 20090608 OTC MONOGRAPH FINAL part336 Insight Pharmaceuticals CHLORCYCLIZINE HYDROCHLORIDE 25 mg/1 E 20171231 63736-050_9b8a641e-489e-497f-a3f0-154d8d836c59 63736-050 HUMAN OTC DRUG Monistat Care Instant Itch Relief Benzocaine SPRAY TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals LLC BENZOCAINE 11.4 g/57g N 20181231 63736-051_ae2068a0-094b-464e-b2b9-924f2aff3cf5 63736-051 HUMAN OTC DRUG Ting Tolnaftate CREAM TOPICAL 20090608 OTC MONOGRAPH FINAL part333 Insight Pharmaceuticals TOLNAFTATE 100 mg/g E 20171231 63736-072_8cbbb896-d9ee-4213-be57-a3647af4abb9 63736-072 HUMAN OTC DRUG Nostrilla Oxymetazoline Hydrochloride SPRAY, METERED NASAL 20090608 OTC MONOGRAPH FINAL part341 Insight Pharmaceuticals OXYMETAZOLINE HYDROCHLORIDE .0005 mL/100mL E 20171231 63736-073_163fdf44-0a0d-4af4-9387-7eb78e82873c 63736-073 HUMAN OTC DRUG Dermarest Psoriasis Medicated Moisturizer Salicylic Acid LOTION TOPICAL 20100723 OTC MONOGRAPH FINAL part358H Insight Pharmaceuticals SALICYLIC ACID 2.36 mL/118mL E 20171231 63736-124_82885c3d-4964-44dd-8bb6-fe55afab3ce7 63736-124 HUMAN OTC DRUG Bonine meclizine hydrochloride TABLET, CHEWABLE ORAL 20090608 OTC MONOGRAPH FINAL part336 Insight Pharmaceuticals MECLIZINE HYDROCHLORIDE 25 mg/1 E 20171231 63736-200_f9e4b28c-3bd5-4f03-bb30-4b64099d3051 63736-200 HUMAN OTC DRUG Anacin Asprin and Caffeine TABLET ORAL 20090625 OTC MONOGRAPH NOT FINAL part343 Insight Pharmaceuticals LLC ASPIRIN; CAFFEINE 400; 32 mg/1; mg/1 N 20181231 63736-205_c763b32e-91b7-4c97-baf5-f523f385a96e 63736-205 HUMAN OTC DRUG CEPASTAT Sore throat and Cough Benzocaine, Dextromethorphan HBr, Menthol LOZENGE ORAL 20161001 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals LLC MENTHOL; BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 10; 6; 5 mg/1; mg/1; mg/1 N 20181231 63736-210_2d148ca6-9415-44c3-a791-d5d3ce13ea7c 63736-210 HUMAN OTC DRUG Pronto Plus Lice Killing Pyrethrum Extract and Piperonyl Butoxide SHAMPOO TOPICAL 20101201 OTC MONOGRAPH FINAL part358G Insight Pharmaceuticals LLC PYRETHRUM EXTRACT; PIPERONYL BUTOXIDE .0033; .04 mL/mL; mL/mL E 20171231 63736-211_795ca46a-30b9-49eb-aaac-f68d2c7e7bb8 63736-211 HUMAN OTC DRUG Anacin ES Aspirin and Caffeine TABLET, COATED ORAL 20090707 OTC MONOGRAPH NOT FINAL part343 Insight Pharmaceuticals ASPIRIN; CAFFEINE 500; 32 mg/1; mg/1 N 20181231 63736-219_a33617f8-fc6a-4c06-8f96-fed5b5d6d570 63736-219 HUMAN OTC DRUG Cepastat Extra Strength Phenol LOZENGE ORAL 20090707 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals PHENOL 29 mg/1 E 20171231 63736-232_017403c5-1be2-46a2-a6eb-63d15265d4ca 63736-232 HUMAN OTC DRUG Auro Ear Wax Remover Carbamide peroxide LIQUID AURICULAR (OTIC) 20100701 OTC MONOGRAPH FINAL part344 Insight Pharmaceuticals LLC CARBAMIDE PEROXIDE 1.44 mL/22mL E 20171231 63736-238_800fac99-b869-45bb-a1f0-4670ea3df88b 63736-238 HUMAN OTC DRUG Stye Mineral Oil and Petrolatum GEL OPHTHALMIC 20100615 OTC MONOGRAPH FINAL part349 Insight Pharmaceuticals MINERAL OIL; PETROLATUM 1; 2 g/4g; g/4g N 20181231 63736-240_05954178-f513-4240-95b8-a411715f05d3 63736-240 HUMAN OTC DRUG Pronto Plus Pinworm Treatment Pyrantel pamoate LIQUID ORAL 20100920 OTC MONOGRAPH FINAL part357B Insight Pharmaceuticals LLC PYRANTEL PAMOATE 5 mL/250mL E 20171231 63736-293_6265bf84-0828-494b-b781-55351012e3e4 63736-293 HUMAN OTC DRUG Skin Shield Benzethonium Chloride and Dyclonine Hydrochloride LIQUID TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part333A Insight Pharmaceuticals BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .0532; .0997 mL/27mL; mL/27mL E 20171231 63736-301_6cf8da32-4bef-4532-a6c3-900f345e07d7 63736-301 HUMAN OTC DRUG Dermarest Psoriasis Medicated Skin Treatment Salicylic Acid GEL TOPICAL 20101020 OTC MONOGRAPH NOT FINAL part358H Insight Pharmaceuticals SALICYLIC ACID 3.54 mL/118mL E 20171231 63736-302_83c9b426-86c9-4e30-91f7-5700ace9789f 63736-302 HUMAN OTC DRUG Dermarest Psoriasis Medicated Salicylic Acid LIQUID TOPICAL 20100723 OTC MONOGRAPH FINAL part358H Insight Pharmaceuticals LLC SALICYLIC ACID 7.08 mL/236mL E 20171231 63736-305_b27a6d5f-5310-4a83-82b0-1a06b9e9859e 63736-305 HUMAN OTC DRUG Caldesene Baby Starch, Corn and Zinc Oxide POWDER TOPICAL 20090707 OTC MONOGRAPH NOT FINAL part347 Insight Pharmaceuticals STARCH, CORN; ZINC OXIDE 115; 21 g/142g; g/142g E 20171231 63736-312_c15309eb-3948-49f3-b790-7105b8493440 63736-312 HUMAN OTC DRUG Dermarest Psoriasis Medicated Scalp Treatment Salicylic Acid GEL TOPICAL 20101220 OTC MONOGRAPH FINAL part358H Insight Pharmaceuticals LLC SALICYLIC ACID 3.54 mL/118mL E 20171231 63736-318_de833a93-7751-40ff-a620-ea7e5d4d8def 63736-318 HUMAN OTC DRUG Gentle Naturals Matricaria Recutita, Tribasic Calcium Phosphate, Potassium Phosphate, Dibasic, Magnesium Phosphate, Dibasic Trihydrate, and Delphinium Staphisagria Seed LIQUID ORAL 20100620 UNAPPROVED HOMEOPATHIC Insight Pharmaceuticals MATRICARIA RECUTITA; TRIBASIC CALCIUM PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; DELPHINIUM STAPHISAGRIA SEED 30; 6; 6; 6; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 63736-324_67d0e4a6-91ac-4aac-bc2d-87cbc131529a 63736-324 HUMAN OTC DRUG Auro Earache Relief MATRICARIA RECUTITA, PLANTAGO MAJOR, VERBASCUM THAPSUS, ATROPA BELLADONNA, CHILI PEPPER, OYSTER SHELL CALCIUM CARBONATE, CRUDE, and POTASSIUM DICHROMATE LIQUID AURICULAR (OTIC) 20100601 UNAPPROVED HOMEOPATHIC Insight Pharmaceuticals MATRICARIA RECUTITA; PLANTAGO MAJOR; VERBASCUM THAPSUS; ATROPA BELLADONNA; CHILI PEPPER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE 4; .3256; .3256; .3256; .3256; .3256; .3256 mL/30mL; mL/30mL; mL/30mL; mL/30mL; mL/30mL; mL/30mL; mL/30mL E 20171231 63736-326_8c257f57-671e-42fd-89a7-e24af7082aa4 63736-326 HUMAN OTC DRUG Auro Homeopathic Ear Relief Drops Atropa Belladonna, Oyster Shell Calcium Carbonate, Crude, Capsicum, Matricaria Recutita, Potassium Dichromate, Plantago Major, and Verbascum Thapsus LIQUID AURICULAR (OTIC) 20131115 UNAPPROVED HOMEOPATHIC Insight Pharmaceuticals ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; MATRICARIA RECUTITA; POTASSIUM DICHROMATE; PLANTAGO MAJOR; VERBASCUM THAPSUS 18; 12; 6; 15; 12; 4; 4 [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL N 20181231 63736-327_28ec5b8b-66e1-4285-b1b2-1304c8aed1be 63736-327 HUMAN OTC DRUG Auro-Dri Isopropyl Alcohol LIQUID AURICULAR (OTIC) 20100614 OTC MONOGRAPH FINAL part344 Insight Pharmaceuticals ISOPROPYL ALCOHOL 28 mL/29mL E 20171231 63736-339_f46a5a8c-9fdf-4039-9159-d452feadc409 63736-339 HUMAN OTC DRUG Dermarest Eczema Medicated Hydrocortisone LOTION TOPICAL 20100920 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals HYDROCORTISONE 1.18 mL/118mL E 20171231 63736-340_2472480b-14b6-4e03-bfaf-0f8d3e4594aa 63736-340 HUMAN OTC DRUG Eucalyptamint Menthol OINTMENT TOPICAL 20090709 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals MENTHOL 9.6 mL/60mL E 20171231 63736-375_766759f1-70ac-4b7b-91cf-849dddfa2fec 63736-375 HUMAN OTC DRUG Americaine Benzocaine OINTMENT TOPICAL 20090710 OTC MONOGRAPH FINAL part346 Insight Pharmaceuticals BENZOCAINE 5.6 g/28g E 20171231 63736-378_8e8a523a-63a8-4680-8189-174f6e91795d 63736-378 HUMAN OTC DRUG Americaine Benzocaine AEROSOL, SPRAY TOPICAL 20090714 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals BENZOCAINE 11.4 g/57g E 20171231 63736-404_24a93c17-af04-4c0c-9d02-a70ddb715aaa 63736-404 HUMAN OTC DRUG Diabet Aid Capsicum Oleoresin LOTION TOPICAL 20100607 OTC MONOGRAPH NOT FINAL part348 Insight Pharmaceuticals CAPSICUM OLEORESIN 3 g/113g E 20171231 63736-410_561d72af-1eae-4009-8576-afc274365166 63736-410 HUMAN OTC DRUG Tioconazole 1 Day Tioconazole OINTMENT TOPICAL 20011121 ANDA ANDA075915 Insight Pharmaceuticals LLC TIOCONAZOLE 300 mg/g N 20181231 63736-532_1f5ea87d-b3e2-452b-bddd-219cf9f80fcd 63736-532 HUMAN OTC DRUG Ting Spray Powder Miconazole Nitrate AEROSOL, POWDER TOPICAL 20090716 OTC MONOGRAPH FINAL part333 Insight Pharmaceuticals MICONAZOLE NITRATE 2.56 g/128g E 20171231 63736-567_80263450-45ca-4950-8d76-c9a37c450fff 63736-567 HUMAN OTC DRUG Sucrets Dyclonine HCl, Menthol, and Pectin LOZENGE ORAL 20141104 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals LLC DYCLONINE HYDROCHLORIDE; MENTHOL; PECTIN 2; 5; 6 mg/1; mg/1; 1/1 N 20181231 63736-586_5297cdf2-d4a4-4b19-b16a-8c016a6be23e 63736-586 HUMAN OTC DRUG Allerest PE Chlorpheniramine Maleate and Phenylephrine Hydrochloride TABLET ORAL 20090731 OTC MONOGRAPH FINAL part341 Insight Pharmaceuticals CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 63736-662_2584355b-c068-4bca-87f6-7854da08610b 63736-662 HUMAN OTC DRUG Privine Naphazoline Hydrochloride SPRAY NASAL 20090716 OTC MONOGRAPH FINAL part341 Insight Pharmaceuticals NAPHAZOLINE HYDROCHLORIDE .1 mL/20mL E 20171231 63736-663_8541b271-ccd6-4c6d-9797-60335e7e4d22 63736-663 HUMAN OTC DRUG Privine Naphazoline Hydrochloride SUSPENSION/ DROPS NASAL 20090716 OTC MONOGRAPH FINAL part341 Insight Pharmaceuticals LLC NAPHAZOLINE HYDROCHLORIDE .125 mL/25mL E 20171231 63736-730_a1afa60c-122e-4135-8714-c8b5d10849d1 63736-730 HUMAN OTC DRUG Nostrilla Oxymetazoline Hydrochloride SPRAY, METERED NASAL 20090608 OTC MONOGRAPH FINAL part341 Insight Pharmaceuticals OXYMETAZOLINE HYDROCHLORIDE .0005 mL/100mL E 20171231 63736-819_3fa290e6-1dca-4df3-b43b-c6b4f68ea468 63736-819 HUMAN OTC DRUG Ting Tolnaftate AEROSOL, SPRAY TOPICAL 20090727 OTC MONOGRAPH FINAL part333 Insight Pharmaceuticals TOLNAFTATE 1.28 g/128g E 20171231 63736-915_ea86fcf2-54a8-4e55-b3f4-f6253ee26129 63736-915 HUMAN OTC DRUG Sucrets MS Wintergreen Dyclonine Hydrochloride LOZENGE ORAL 20090728 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals DYCLONINE HYDROCHLORIDE 3 mg/1 E 20171231 63736-920_69e602c4-85c4-4b79-ba38-f16063084cc1 63736-920 HUMAN OTC DRUG Sucrets Complete Vapor Cherry Dyclonine Hydrochloride and Menthol LOZENGE ORAL 20090731 OTC MONOGRAPH NOT FINAL part356 Insight Pharmaceuticals DYCLONINE HYDROCHLORIDE; MENTHOL 3; 6 mg/1; mg/1 E 20171231 63736-961_209f2526-8267-4dce-80f5-6c5ae31a21dc 63736-961 HUMAN OTC DRUG Uristat UTI Relief Pak Phenazopyridine Hydrochloride TABLET ORAL 20150429 UNAPPROVED DRUG OTHER Insight Pharmaceuticals LLC PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 E 20171231 63739-003_872cb75f-0414-42ab-915e-9ddd96d1f6a4 63739-003 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120628 ANDA ANDA071457 McKesson Corporation TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63739-004_8579c0e9-48bf-438e-a783-2f2b6c99944e 63739-004 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine Phosphate acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Mckesson Packaging Services a business unit of McKesson Corporation ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 63739-005_aa071e67-1bf0-4746-af4c-847261f6d910 63739-005 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 McKesson Packaging Services a business unit of McKesson Corporation ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 63739-006_7d83edfd-b529-41b6-beea-e91316dd0c7b 63739-006 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20120116 ANDA ANDA090635 McKesson Packaging Services a business unit of McKesson Corporation METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63739-007_45314bb7-91e5-4cd4-b38a-83097812e6a9 63739-007 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20070701 ANDA ANDA078220 McKesson Packaging Services a business unit of McKesson Corporation BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 63739-013_c7724398-c494-4c66-8d50-672bde9446aa 63739-013 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20160718 ANDA ANDA074260 McKesson Corporation CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 63739-014_2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec 63739-014 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 McKesson Corporation DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63739-015_2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec 63739-015 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 McKesson Corporation DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63739-016_2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec 63739-016 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 McKesson Corporation DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63739-017_c7724398-c494-4c66-8d50-672bde9446aa 63739-017 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20160718 ANDA ANDA074260 McKesson Corporation CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 63739-019_83eb75bf-d985-4016-aeb1-47fa57a125ce 63739-019 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090115 ANDA ANDA079063 McKesson Corporation LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63739-029_95f3ef3c-4843-4526-a473-7397f367e372 63739-029 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040627 McKesson Corporation BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 63739-038_216ec984-90a9-4b81-aa07-eb7f7cd2f5f3 63739-038 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir phosphate CAPSULE ORAL 20161212 ANDA ANDA202595 McKesson Packaging Services OSELTAMIVIR PHOSPHATE 30 mg/1 N 20181231 63739-044_216ec984-90a9-4b81-aa07-eb7f7cd2f5f3 63739-044 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir phosphate CAPSULE ORAL 20161212 ANDA ANDA202595 McKesson Packaging Services OSELTAMIVIR PHOSPHATE 45 mg/1 N 20181231 63739-046_30ec915a-9a98-4ab6-965c-24a140fbba63 63739-046 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930301 ANDA ANDA073618 McKesson Packaging Services a business unit of McKesson Corporation CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 63739-047_30ec915a-9a98-4ab6-965c-24a140fbba63 63739-047 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930401 ANDA ANDA073589 McKesson Packaging Services a business unit of McKesson Corporation CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 63739-048_30ec915a-9a98-4ab6-965c-24a140fbba63 63739-048 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 19930101 ANDA ANDA073607 McKesson Packaging Services a business unit of McKesson Corporation CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 63739-049_e760f6a1-9781-41a0-bcb1-69ccefeea80c 63739-049 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 McKesson Corporation CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 63739-050_216ec984-90a9-4b81-aa07-eb7f7cd2f5f3 63739-050 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir phosphate CAPSULE ORAL 20161212 ANDA ANDA202595 McKesson Packaging Services OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 63739-059_363d5e7d-2734-4a26-8b7c-a75a707dbaae 63739-059 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20070806 ANDA ANDA063083 McKesson Packaging Services Business Unit of McKesson Corporation CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 63739-060_f84327ee-ffe0-43bd-b431-98b15d3ad15e 63739-060 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070974 McKesson Packaging Services a business unit of McKesson Corporation CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 63739-073_e78b85c4-d403-43be-93e6-8cf85ed63215 63739-073 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20061115 ANDA ANDA071135 McKesson Packaging Services Business Unit of McKesson Corporation DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 63739-079_da1c1a8e-c9dd-4c20-b061-638f2d0cecda 63739-079 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, COATED ORAL 20070810 ANDA ANDA074185 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 63739-080_da1c1a8e-c9dd-4c20-b061-638f2d0cecda 63739-080 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, COATED ORAL 20070810 ANDA ANDA074185 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 63739-089_62c8ffe5-321f-4747-ad38-db2c54a393ae 63739-089 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20041201 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation DOCUSATE SODIUM 100 mg/1 N 20181231 63739-103_03f383e4-352b-46b3-af63-644e63702b68 63739-103 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA072750 McKesson Packaging Services a business unit of McKesson Corporation METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 63739-110_144ee59e-bf4b-462d-8b67-3863836e36ca 63739-110 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20041124 ANDA ANDA080600 McKesson Packaging Services Business Unit of McKesson Corporation. FOLIC ACID 1 mg/1 E 20171231 63739-119_cd0edefd-2cb0-481b-a06f-65427c80d0e3 63739-119 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 McKesson Packaging Services a business unit of McKesson Corporation GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 63739-124_95f3ef3c-4843-4526-a473-7397f367e372 63739-124 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040749 McKesson Corporation BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 63739-125_872cb75f-0414-42ab-915e-9ddd96d1f6a4 63739-125 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 McKesson Corporation TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63739-126_fac243d2-f121-4e7a-9dbf-ad40f8af12b4 63739-126 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA088467 McKesson Packaging Services a business unit of McKesson Corporation HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 63739-127_fac243d2-f121-4e7a-9dbf-ad40f8af12b4 63739-127 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA088468 McKesson Packaging Services a business unit of McKesson Corporation HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 63739-128_69854128-4e2c-4a86-be4a-74fbad253f49 63739-128 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 McKesson Packaging Services a business unit of McKesson Corporation HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63739-133_56718982-4ccf-47a4-8052-ac7de45e13a8 63739-133 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 19981222 ANDA ANDA040183 McKesson Packaging Services a business unit of McKesson Corporation METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 63739-134_3d055404-f915-40a4-8f8f-7bc72ee2ce02 63739-134 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, SUGAR COATED ORAL 20050110 ANDA ANDA071163 McKesson Packaging Services Business Unit of McKesson Corporation IBUPROFEN 200 mg/1 N 20181231 63739-154_d200ba28-2c61-4bd1-9f00-817e6f3c4be5 63739-154 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19990728 ANDA ANDA071193 McKesson Packaging Services Business Unit of McKesson Corporation LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-155_d200ba28-2c61-4bd1-9f00-817e6f3c4be5 63739-155 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19990728 ANDA ANDA071194 McKesson Packaging Services Business Unit of McKesson Corporation LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-156_d200ba28-2c61-4bd1-9f00-817e6f3c4be5 63739-156 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19990728 ANDA ANDA071195 McKesson Packaging Services Business Unit of McKesson Corporation LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-165_1e5e6461-83a0-4d6d-b5b0-d84e00e536ed 63739-165 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20070820 ANDA ANDA072423 McKesson Packaging Services a business unit of McKesson Corporation MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 63739-166_a106efef-a36d-49e2-b527-754228d2c6d7 63739-166 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 McKesson Packaging Services a business unit of McKesson Corporation METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 63739-167_a106efef-a36d-49e2-b527-754228d2c6d7 63739-167 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 McKesson Packaging Services a business unit of McKesson Corporation METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 63739-168_058f90c6-e757-4409-b148-f6449c972160 63739-168 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19830202 ANDA ANDA062421 McKesson Packaging Services a business unit of McKesson Corporation DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 63739-177_7a1c76c9-67b7-45e8-a0b3-989d21ebc95d 63739-177 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 McKesson Corporation OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 63739-200_7b15c232-d2d8-41f6-b45a-475405c02fb0 63739-200 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20070905 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation PHENOBARBITAL 16.2 mg/1 CIV E 20171231 63739-201_7b15c232-d2d8-41f6-b45a-475405c02fb0 63739-201 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20070717 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation PHENOBARBITAL 32.4 mg/1 CIV E 20171231 63739-213_6b052e22-7650-4cfa-930a-55d128f07a59 63739-213 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19751219 ANDA ANDA084176 McKesson Packaging Services a business unit of McKesson Corporation PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 63739-217_f43aef42-9ba4-47c9-bfda-da151526460a 63739-217 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040778 McKesson Packaging Services a business unit of McKesson Corporation OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63739-228_4c19426b-91c8-46a3-ab23-19bb84281424 63739-228 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070924 ANDA ANDA071017 McKesson Packaging Services a business unit of McKesson Corporation SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 63739-231_2fad5d00-5ef0-4097-a880-720c3c09d5d0 63739-231 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071427 McKesson Packaging Services a business unit of McKesson Corporation TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63739-236_03017ff1-5fc4-42e6-a66c-681bc27b009f 63739-236 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63739-251_54bcb1e8-4763-47ad-80c8-4b052cf8ef58 63739-251 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE, LIQUID FILLED ORAL 20050301 ANDA ANDA073229 McKesson Packaging Services Business Unit of McKesson Corporation VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63739-263_e0c27a29-b895-4132-a2c2-8da4c0722d03 63739-263 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20070801 ANDA ANDA074869 McKesson Packaging Services Business Unit of McKesson Corporation CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-264_e0c27a29-b895-4132-a2c2-8da4c0722d03 63739-264 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20070802 ANDA ANDA074869 McKesson Packaging Services Business Unit of McKesson Corporation CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-265_b6ad3983-54fa-4b18-ade1-a3ff7d8f178e 63739-265 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20070719 ANDA ANDA076243 McKesson Corporation LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 63739-266_7b5c59ae-e4c1-4097-9db1-f6837b7c3688 63739-266 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20040701 ANDA ANDA075180 McKesson Packaging Services Business Unit of McKesson Corporation RANITIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 63739-269_03aa160e-65cb-4bc7-afd8-157666e39b8c 63739-269 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20070914 ANDA ANDA075797 McKesson Packaging Services Business Unit of McKesson Corporation TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 63739-275_55a7ddc9-d358-4441-b214-d819d83e1b47 63739-275 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 McKesson Packaging Services a business unit of McKesson Corporation HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63739-281_722a733e-60ee-4ef8-83d8-a3196160ac76 63739-281 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20070912 ANDA ANDA075828 McKesson Packaging Services Business Unit of McKesson Corporation LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63739-282_722a733e-60ee-4ef8-83d8-a3196160ac76 63739-282 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20070806 ANDA ANDA075828 McKesson Packaging Services Business Unit of McKesson Corporation LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63739-283_13b758d6-fbd8-4783-80c5-fcfa7f3abe42 63739-283 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100524 ANDA ANDA074984 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63739-283_f09940d3-82d7-4503-b7c4-c3ef37fdacfe 63739-283 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070724 ANDA ANDA074984 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63739-284_13b758d6-fbd8-4783-80c5-fcfa7f3abe42 63739-284 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100524 ANDA ANDA074984 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63739-284_f09940d3-82d7-4503-b7c4-c3ef37fdacfe 63739-284 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070621 ANDA ANDA074984 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63739-285_13b758d6-fbd8-4783-80c5-fcfa7f3abe42 63739-285 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100524 ANDA ANDA074984 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63739-285_f09940d3-82d7-4503-b7c4-c3ef37fdacfe 63739-285 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070724 ANDA ANDA074984 McKesson Packaging Services Business Unit of McKesson Corporation DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 63739-291_bba98e57-7056-4143-8fcd-95e25539d087 63739-291 HUMAN OTC DRUG Oyster Shell Calcium with Vitamin D Oyster Shell Calcium with Vitamin D TABLET, FILM COATED ORAL 20051115 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation CALCIUM; CHOLECALCIFEROL 500; 200 mg/1; [iU]/1 E 20171231 63739-293_03f383e4-352b-46b3-af63-644e63702b68 63739-293 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 McKesson Packaging Services a business unit of McKesson Corporation METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 63739-325_991d2b13-f491-4a25-8ea7-5136d0585874 63739-325 HUMAN PRESCRIPTION DRUG FAMOTIDINE FAMOTIDINE TABLET, FILM COATED ORAL 20070612 ANDA ANDA075718 McKesson Packaging Services Business Unit of McKesson Corporation FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 63739-326_b623883e-8684-4e79-bb70-a6802e23f090 63739-326 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 McKesson Packaging Services a business unit of McKesson Corporation HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 63739-349_57787670-4749-454d-8a71-12a606f9a451 63739-349 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 McKesson Packaging Services a business unit of McKesson Corporation LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63739-350_57787670-4749-454d-8a71-12a606f9a451 63739-350 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 McKesson Packaging Services a business unit of McKesson Corporation LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 63739-355_4531cb5a-64ca-4e6a-98c2-7aaad8d7f630 63739-355 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070807 ANDA ANDA076119 McKesson Packaging Services Business Unit of McKesson Corporation MIRTAZAPINE 15 mg/1 E 20171231 63739-356_4531cb5a-64ca-4e6a-98c2-7aaad8d7f630 63739-356 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070914 ANDA ANDA076119 McKesson Packaging Services Business Unit of McKesson Corporation MIRTAZAPINE 30 mg/1 E 20171231 63739-357_e937f02d-a76c-4a2f-b9ad-84897391580f 63739-357 HUMAN PRESCRIPTION DRUG VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE TABLET ORAL 20160331 ANDA ANDA204750 McKesson Corporation VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 63739-358_6a50bedf-c6dc-444c-8db7-7f23396fc2da 63739-358 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 McKesson Corporation OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63739-365_7a1c76c9-67b7-45e8-a0b3-989d21ebc95d 63739-365 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 McKesson Corporation OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 63739-366_a049113a-66b0-482f-beaf-b07026809c82 63739-366 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20061115 ANDA ANDA075113 McKesson Corporation LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 63739-367_8afcf7eb-d642-4605-841c-902e0ea896ea 63739-367 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19811215 ANDA ANDA087537 McKesson Packaging Services a business unit of McKesson Corporation ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 63739-387_50ba44a8-4bdf-41bc-a191-b26b3291cadb 63739-387 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 19981223 ANDA ANDA075315 McKesson Corporation AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 63739-391_e35a7856-eb8c-4cf1-9749-f9ee52678360 63739-391 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20040214 ANDA ANDA075694 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63739-403_02dcffa7-1968-4bd3-a801-eddeed1703e4 63739-403 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 McKesson Packaging Services a business unit of McKesson Corporation NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63739-404_4813f476-3637-4f0f-abdd-c76c4074f8ae 63739-404 HUMAN PRESCRIPTION DRUG Metolazone Metolazone TABLET ORAL 20061115 ANDA ANDA076466 McKesson Packaging Services a business unit of McKesson Corporation METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 63739-410_a53ef63e-7503-46e2-978f-cc49180b508a 63739-410 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20091116 ANDA ANDA078253 McKesson Corporation ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 63739-411_ae31074f-4d5e-4e01-9aef-3abbe711a0d8 63739-411 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 McKesson Packaging Services a business unit of McKesson Corporation LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63739-415_36579a56-4555-4211-93c5-bb7d9a729b01 63739-415 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20061130 ANDA ANDA064150 McKesson Packaging Services a business unit of McKesson Corporation RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 63739-416_922b2c82-052a-416c-984f-0dd66f2c61c4 63739-416 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20090818 ANDA ANDA089424 McKesson Packaging Services Business Unit of McKesson Corporation SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 63739-431_7a0b096b-ab37-4ffd-8d88-7f91e6ed60da 63739-431 HUMAN OTC DRUG Senna-Time Senna-Time TABLET, COATED ORAL 20071012 UNAPPROVED DRUG OTHER McKesson Packaging Services Business Unit of McKesson Corporation SENNOSIDES 8.6 mg/1 N 20181231 63739-432_4258fc68-ac29-491c-b7bc-ed5d35b23107 63739-432 HUMAN OTC DRUG Sennosides and Docusate Sodium Sennosides and Docusate Sodium TABLET ORAL 20071011 UNAPPROVED DRUG OTHER McKesson Packaging Services a business unit of McKesson Corporation SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 63739-434_56279fd2-bec3-4d77-86dd-2a3bd46c6109 63739-434 HUMAN OTC DRUG Aspirin Chewable Aspirin 81 mg TABLET ORAL 20141218 OTC MONOGRAPH FINAL part343 McKesson Packaging Services a business unit of McKesson Corporation ASPIRIN 81 mg/1 E 20171231 63739-435_5977d097-7eb5-48c8-be1b-e0e7ddb1ffa2 63739-435 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080331 ANDA ANDA077837 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63739-436_5977d097-7eb5-48c8-be1b-e0e7ddb1ffa2 63739-436 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080331 ANDA ANDA077837 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63739-437_5977d097-7eb5-48c8-be1b-e0e7ddb1ffa2 63739-437 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080331 ANDA ANDA077837 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63739-438_5977d097-7eb5-48c8-be1b-e0e7ddb1ffa2 63739-438 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20080331 ANDA ANDA077837 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63739-440_9e296255-930d-4162-b0c2-a38ebc1d74d5 63739-440 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20090301 OTC MONOGRAPH NOT FINAL part343 McKesson Packaging Services Business Unit of McKesson Corporation ACETAMINOPHEN 325 mg/1 E 20171231 63739-445_6a50bedf-c6dc-444c-8db7-7f23396fc2da 63739-445 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090123 ANDA ANDA075410 McKesson Corporation OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 63739-446_e3deb79f-888c-4ebc-8b30-c5256d2b9a06 63739-446 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20090803 ANDA ANDA074726 McKesson Packaging Services Business Unit of McKesson Corporation POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 63739-447_e3deb79f-888c-4ebc-8b30-c5256d2b9a06 63739-447 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20090810 ANDA ANDA074726 McKesson Packaging Services Business Unit of McKesson Corporation POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 63739-448_d44bd66b-90e6-4447-803c-7c3bc02bf877 63739-448 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20100120 ANDA ANDA076708 McKesson Packaging Services Business Unit of McKesson Corporation LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63739-451_2e9d7efb-8ffe-4dbe-bf0f-98ffb19483ce 63739-451 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20100719 ANDA ANDA077899 McKesson Packaging Services Business Unit of McKesson Corporation NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63739-452_2e9d7efb-8ffe-4dbe-bf0f-98ffb19483ce 63739-452 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20100719 ANDA ANDA077899 McKesson Packaging Services Business Unit of McKesson Corporation NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63739-454_361cc106-6167-43e1-93af-46b3faa5cedf 63739-454 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20110202 ANDA ANDA077298 McKesson Packaging Services Business Unit of McKesson Corporation METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 63739-456_3af22732-ff86-4ae2-813a-d2bcf0924471 63739-456 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION INTRACARDIAC; INTRAVENOUS 20100503 NDA NDA020800 McKesson Packaging Services Business Unit of McKesson Corporation EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 63739-457_95e8a1e3-04c7-433f-ae8c-afa1c0d61deb 63739-457 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20100503 ANDA ANDA040302 McKesson Packaging Services Business Unit of McKesson Corporation LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 63739-459_4e23837d-d376-4c8e-a94e-1ddb585dbbf7 63739-459 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride Procainamide Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20100201 ANDA ANDA089069 McKesson Packaging Services Business Unit of McKesson Corporation PROCAINAMIDE HYDROCHLORIDE 100 mg/mL Antiarrhythmic [EPC] E 20171231 63739-460_343adf7b-6aaf-47a0-8419-a67cd09363dc 63739-460 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION, SOLUTION INTRAVENOUS 20100503 NDA NDA077394 McKesson Packaging Services Business Unit of McKesson Corporation SODIUM BICARBONATE 84 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 63739-463_1a757301-419a-457e-9989-cdf57c902988 63739-463 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100503 ANDA ANDA070254 McKesson Packaging Services Business Unit of McKesson Corporation NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] E 20171231 63739-464_19152554-70b0-42fb-a3d5-65ceb00e60e3 63739-464 HUMAN PRESCRIPTION DRUG Furosemide furosemide INJECTION INTRAMUSCULAR; INTRAVENOUS 20100201 NDA NDA018579 McKesson Packaging Services Business unit of McKesson Corporation FUROSEMIDE 20 mg/2mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 63739-466_ee8fe2ea-a6c7-485e-bea9-1b94ff66b05c 63739-466 HUMAN PRESCRIPTION DRUG Nalbuphine Hydrochloride Nalbuphine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20100503 ANDA ANDA070916 McKesson Packaging Services Business Unit of McKesson Corporation NALBUPHINE HYDROCHLORIDE 20 mg/mL Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] E 20171231 63739-468_3365c3d6-28a0-420d-89a7-9bc9b8539d4c 63739-468 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100503 ANDA ANDA089644 McKesson Packaging Services Business Unit of McKesson Corporation LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE 10; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 63739-469_195030df-bf46-49f7-9fc0-1351100a7d41 63739-469 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100503 ANDA ANDA088299 McKesson Packaging Services Business Unit of McKesson Corporation LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 63739-470_195030df-bf46-49f7-9fc0-1351100a7d41 63739-470 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION INFILTRATION 20100503 ANDA ANDA088327 McKesson Packaging Services Business Unit of McKesson Corporation LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 63739-475_3365c3d6-28a0-420d-89a7-9bc9b8539d4c 63739-475 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride and Epinephrine lidocaine hydrochloride anhydrous and epinephrine INJECTION, SOLUTION INFILTRATION 20100503 ANDA ANDA089646 McKesson Packaging Services Business Unit of McKesson Corporation LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE 20; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 63739-478_63ff4aff-69eb-4a43-bdc7-050d9afdc6f9 63739-478 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20101109 UNAPPROVED DRUG OTHER McKesson Corporation DOCUSATE SODIUM 100 mg/1 N 20181231 63739-479_64668b46-71a9-429f-a4a5-58b13c55a343 63739-479 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110101 ANDA ANDA078504 McKesson Packaging Services a business unit of McKesson Corporation BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 63739-480_64668b46-71a9-429f-a4a5-58b13c55a343 63739-480 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110101 ANDA ANDA078401 McKesson Packaging Services a business unit of McKesson Corporation BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 63739-481_4b240b5f-18ac-4bd7-9385-59569cb570d8 63739-481 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110317 ANDA ANDA078374 McKesson Packaging Services a business unit of McKesson Corporation METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 63739-482_4b240b5f-18ac-4bd7-9385-59569cb570d8 63739-482 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110317 ANDA ANDA078374 McKesson Packaging Services a business unit of McKesson Corporation METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 63739-483_e95dc651-fc19-4a3f-b50f-e99107ce8b07 63739-483 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride TABLET ORAL 20091111 ANDA ANDA040840 McKesson Packaging Services a business unit of McKesson Corporation HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63739-486_e95dc651-fc19-4a3f-b50f-e99107ce8b07 63739-486 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride TABLET ORAL 20091111 ANDA ANDA040840 McKesson Packaging Services a business unit of McKesson Corporation HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 63739-489_a35fe4f2-e63d-4503-9e81-852376f2476e 63739-489 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20121106 ANDA ANDA077824 McKesson Packaging Services Business Unit of McKesson Corporation RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 63739-490_e6d920ee-80bc-4247-8b50-77f463130d38 63739-490 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20101201 ANDA ANDA077206 McKesson Packaging Services Business Unit of McKesson Corporation SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 63739-493_59de2889-c3d3-4ebf-8826-13f30a3fa439 63739-493 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Capsules CAPSULE ORAL 20101118 ANDA ANDA090223 McKesson Packaging Services Business Unit of McKesson Corporation FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63739-494_59de2889-c3d3-4ebf-8826-13f30a3fa439 63739-494 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Capsules CAPSULE ORAL 20101118 ANDA ANDA090223 McKesson Packaging Services Business Unit of McKesson Corporation FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63739-495_da78d7ba-d9de-4b04-b088-640547ae1a98 63739-495 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20101122 ANDA ANDA077914 McKesson Packaging Services Business Unit of McKesson Corporation FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 63739-499_ee1d91f5-5330-4a09-9dc5-fb1505a507cc 63739-499 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100901 ANDA ANDA072926 McKesson Packaging Services Business Unit of McKesson Corporation LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-500_ee1d91f5-5330-4a09-9dc5-fb1505a507cc 63739-500 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100901 ANDA ANDA072927 McKesson Packaging Services Business Unit of McKesson Corporation LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-501_ee1d91f5-5330-4a09-9dc5-fb1505a507cc 63739-501 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20100901 ANDA ANDA072928 McKesson Packaging Services Business Unit of McKesson Corporation LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-508_aa071e67-1bf0-4746-af4c-847261f6d910 63739-508 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 McKesson Packaging Services a business unit of McKesson Corporation ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 63739-509_cf103bcc-5b96-4699-be2c-d596d490a814 63739-509 HUMAN PRESCRIPTION DRUG Propafenone HCl Propafenone hydrochloride TABLET, FILM COATED ORAL 20120910 ANDA ANDA075203 McKesson Packaging Services a business unit of McKesson Corporation PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] E 20171231 63739-510_cf103bcc-5b96-4699-be2c-d596d490a814 63739-510 HUMAN PRESCRIPTION DRUG Propafenone HCl Propafenone hydrochloride TABLET, FILM COATED ORAL 20120910 ANDA ANDA075203 McKesson Packaging Services a business unit of McKesson Corporation PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] E 20171231 63739-512_008aaf35-b9ca-4e0a-8713-c6d5cb80b2f5 63739-512 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121015 ANDA ANDA076565 McKesson Packaging Services a business unit of McKesson Corporation VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63739-513_4b85bb76-96b1-4854-8946-50611ca48382 63739-513 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090382 McKesson Packaging Services a business unit of McKesson Corporation LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63739-514_4b85bb76-96b1-4854-8946-50611ca48382 63739-514 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090382 McKesson Packaging Services a business unit of McKesson Corporation LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63739-515_4b85bb76-96b1-4854-8946-50611ca48382 63739-515 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090382 McKesson Packaging Services a business unit of McKesson Corporation LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63739-516_5fb7c70d-410f-46a6-9906-edd5106c34d0 63739-516 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110608 ANDA ANDA090607 McKesson Packaging Services a buisness unit of McKesson Corporation LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63739-517_5fb7c70d-410f-46a6-9906-edd5106c34d0 63739-517 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110608 ANDA ANDA090607 McKesson Packaging Services a buisness unit of McKesson Corporation LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63739-518_5c0d93cb-c49f-4c1c-bc63-236c9a86c9c5 63739-518 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 McKesson Packaging Services a business unit of McKesson Corporation PREDNISONE 5 mg/1 E 20171231 63739-519_5c0d93cb-c49f-4c1c-bc63-236c9a86c9c5 63739-519 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 McKesson Packaging Services a business unit of McKesson Corporation PREDNISONE 10 mg/1 E 20171231 63739-520_5c0d93cb-c49f-4c1c-bc63-236c9a86c9c5 63739-520 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 McKesson Packaging Services a business unit of McKesson Corporation PREDNISONE 20 mg/1 E 20171231 63739-522_3e8bb204-a480-4a74-bfb6-28be4e69c2ad 63739-522 HUMAN OTC DRUG aspirin low dose enteric coated aspirin TABLET, COATED ORAL 20121113 OTC MONOGRAPH FINAL part343 McKesson Packaging Services Business Unit of McKesson Corporation ASPIRIN 81 mg/1 E 20171231 63739-523_a3fed359-1e27-4002-bfc7-9b90c1febe6d 63739-523 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength Aspirin TABLET, DELAYED RELEASE ORAL 20130628 OTC MONOGRAPH FINAL part343 McKesson Corporation ASPIRIN 325 mg/3251 N 20181231 63739-525_bb76a751-0ed6-41ab-89b4-1376bced9509 63739-525 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20110523 ANDA ANDA090682 McKesson Packaging Services a business unit of McKesson Corporation VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 63739-526_db6549a5-4883-4fd7-8a10-04f90913bbc7 63739-526 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20110601 ANDA ANDA078413 McKesson Packaging Services Business Unit of McKesson Corporation ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 63739-527_768a363a-c814-4ef5-a37f-90fddf690c07 63739-527 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20110601 ANDA ANDA091629 McKesson Packaging Services a business unit of McKesson Corporation LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63739-528_768a363a-c814-4ef5-a37f-90fddf690c07 63739-528 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20110601 ANDA ANDA091629 McKesson Packaging Services a business unit of McKesson Corporation LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63739-529_768a363a-c814-4ef5-a37f-90fddf690c07 63739-529 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20110601 ANDA ANDA091629 McKesson Packaging Services a business unit of McKesson Corporation LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 63739-531_ac09241f-3425-4c26-8401-73b093ca13a6 63739-531 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 McKesson Packaging Services a business unit of McKesson Corporation CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 63739-537_a3821fb7-3664-4090-97c7-458462f3488f 63739-537 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20111017 ANDA ANDA040756 McKesson Packaging Services a business unit of McKesson Corporation FOLIC ACID 1 mg/1 E 20171231 63739-539_3300d5d4-40e3-4006-ae7b-e848d4a72495 63739-539 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20111101 ANDA ANDA079107 McKesson Corporation LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63739-541_da723663-5920-428c-9d86-cd43fd6975be 63739-541 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110822 ANDA ANDA078010 McKesson Packaging Services a business unit of McKesson Corporation FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63739-542_da723663-5920-428c-9d86-cd43fd6975be 63739-542 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110725 ANDA ANDA078010 McKesson Packaging Services a business unit of McKesson Corporation FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63739-543_da723663-5920-428c-9d86-cd43fd6975be 63739-543 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110822 ANDA ANDA078010 McKesson Packaging Services a business unit of McKesson Corporation FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 63739-544_2c7d3a90-bd99-4fb3-8d26-366d69aee184 63739-544 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20110601 ANDA ANDA091426 McKesson Packaging Services a business unit of McKesson Corporation SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 63739-545_2c7d3a90-bd99-4fb3-8d26-366d69aee184 63739-545 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20110601 ANDA ANDA091426 McKesson Packaging Services a business unit of McKesson Corporation SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 63739-546_9ebb0568-141c-43d0-8056-a9afe4ce3d4e 63739-546 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120213 ANDA ANDA078707 McKesson Packaging Services a business unit of McKesson Corporation RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 63739-547_9ebb0568-141c-43d0-8056-a9afe4ce3d4e 63739-547 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120319 ANDA ANDA078707 McKesson Packaging Services a business unit of McKesson Corporation RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 63739-548_c8a755b6-881f-4568-8d1b-1347755230c9 63739-548 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20120518 ANDA ANDA078503 McKesson Packaging Services a business unit of McKesson Corporation OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 63739-549_3d8419fa-e990-4183-93bc-dce26295d25a 63739-549 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20130308 ANDA ANDA075671 McKesson Packaging Services a business unit of McKesson Corporation MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 63739-552_bb76a751-0ed6-41ab-89b4-1376bced9509 63739-552 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20120224 ANDA ANDA090682 McKesson Packaging Services a business unit of McKesson Corporation VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 63739-553_0f132d75-af5c-4ac1-8e46-afd6ef10a0d5 63739-553 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120123 ANDA ANDA078853 McKesson Packaging Services a business unit of McKesson Corporation DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63739-554_0f132d75-af5c-4ac1-8e46-afd6ef10a0d5 63739-554 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120123 ANDA ANDA078853 McKesson Packaging Services a business unit of McKesson Corporation DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63739-555_fb615f0b-67ff-4a7f-b1b8-70095f054b51 63739-555 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120921 ANDA ANDA091269 McKesson Packaging Services a business unit of McKesson Corporation LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 63739-556_2b24f75c-539b-4a96-802e-f3cc3b55dae2 63739-556 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20121126 ANDA ANDA076514 McKesson Packaging Services a business unit of McKesson Corporation MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 63739-557_02304ee1-ad6b-47cc-9ade-5b7c61d4f5a7 63739-557 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20120521 ANDA ANDA076642 McKesson Packaging Services a business unit of McKesson Corporation HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 63739-559_f38e618b-539b-426b-aef2-8194f63e918d 63739-559 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20121120 ANDA ANDA077859 McKesson Packaging Services a business unit of McKesson Corporation CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 63739-560_fbcc94fb-5a74-4aec-b3c0-c3b70f750dd3 63739-560 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20121016 ANDA ANDA078926 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63739-564_199d4792-2b36-47d0-81f1-99e29810e36b 63739-564 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 McKesson Packaging Services a business unit of McKesson Corporation PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 63739-567_45e97516-5a96-470d-92e2-dd9d85bb170c 63739-567 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078225 McKesson Packaging Services a business unit of McKesson Corporation TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 63739-569_8afcf7eb-d642-4605-841c-902e0ea896ea 63739-569 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19791222 ANDA ANDA086925 McKesson Packaging Services a business unit of McKesson Corporation ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 63739-570_0876c6ec-99cf-466d-ae83-9531c0fab1e9 63739-570 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130117 ANDA ANDA077691 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63739-571_0876c6ec-99cf-466d-ae83-9531c0fab1e9 63739-571 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20121220 ANDA ANDA077691 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63739-572_0876c6ec-99cf-466d-ae83-9531c0fab1e9 63739-572 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20121122 ANDA ANDA077691 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63739-573_0876c6ec-99cf-466d-ae83-9531c0fab1e9 63739-573 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20121122 ANDA ANDA077691 McKesson Packaging Services a business unit of McKesson Corporation SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 63739-574_fb615f0b-67ff-4a7f-b1b8-70095f054b51 63739-574 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120921 ANDA ANDA091269 McKesson Packaging Services a business unit of McKesson Corporation LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] E 20171231 63739-575_1998db12-6000-44a9-ad8a-2ffea3edfb8d 63739-575 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20131202 ANDA ANDA065211 McKesson Corporation AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 63739-576_8dc97a13-c5eb-4421-ae86-7e0877186e2d 63739-576 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130301 ANDA ANDA077129 McKesson Packaging Services a business unit of McKesson Corporation RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 63739-577_8dc97a13-c5eb-4421-ae86-7e0877186e2d 63739-577 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130201 ANDA ANDA077129 McKesson Packaging Services a business unit of McKesson Corporation RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 63739-578_8dc97a13-c5eb-4421-ae86-7e0877186e2d 63739-578 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130301 ANDA ANDA077129 McKesson Packaging Services a business unit of McKesson Corporation RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 63739-579_8dc97a13-c5eb-4421-ae86-7e0877186e2d 63739-579 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20130301 ANDA ANDA077129 McKesson Packaging Services a business unit of McKesson Corporation RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 63739-588_480e2573-7ad2-48a0-9c97-bcc5587aa7fe 63739-588 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA085161 McKesson Packaging Services a business unit or McKesson Corporation PREDNISONE 20 mg/1 E 20171231 63739-591_03017ff1-5fc4-42e6-a66c-681bc27b009f 63739-591 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63739-631_7373087b-f500-42e4-b5f4-4676e3033bbf 63739-631 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 McKesson Corporation AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 63739-633_e10b61c2-f4cd-45e6-821f-48033fdd9100 63739-633 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140527 ANDA ANDA078865 McKesson Packaging Services a business unit of McKesson Corporation VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63739-634_4481429a-88bc-418a-9e87-ac3ec0a9a80f 63739-634 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 19950415 ANDA ANDA062512 McKesson Packaging Services a business unit of McKesson Corporation NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 63739-636_b3095947-76b0-48c9-9021-b69667c47b15 63739-636 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120117 ANDA ANDA202677 McKesson Corporation OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63739-640_d44032f3-912e-4285-885e-10eef409a0c2 63739-640 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 McKesson Packaging Services a business unit of McKesson Corporation METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 63739-644_85219ef9-d2ff-4037-b398-fae5e277ed4e 63739-644 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20140429 ANDA ANDA074112 McKesson Packaging Services a business unit of McKesson Corporation ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-645_510a7cd1-52eb-40b0-a7f1-81bebf9ae2a6 63739-645 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 McKesson Packaging Services a business unit of McKesson Corporation FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 63739-646_a194a249-4e2f-431b-8bf0-62c5355b04b6 63739-646 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET ORAL 20110531 ANDA ANDA090290 McKesson Packaging Services a business unit of McKesson Corporation DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 63739-655_d44032f3-912e-4285-885e-10eef409a0c2 63739-655 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 McKesson Packaging Services a business unit of McKesson Corporation METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 63739-665_1de66e94-0669-4098-90d6-4c62ef5f114d 63739-665 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 McKesson Packaging Services a business unit of McKesson Corporation QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 63739-666_aa071e67-1bf0-4746-af4c-847261f6d910 63739-666 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 McKesson Packaging Services a business unit of McKesson Corporation ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 63739-669_85219ef9-d2ff-4037-b398-fae5e277ed4e 63739-669 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20140429 ANDA ANDA074112 McKesson Packaging Services a business unit of McKesson Corporation ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-670_5bb31c31-86f9-4ef6-8b94-d6d778079561 63739-670 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20140205 ANDA ANDA077633 McKesson Packaging Sevices a business unit of McKesson Corporation LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 63739-671_8ad9d318-4968-4dba-8898-83c286aad2ef 63739-671 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20131202 ANDA ANDA076003 McKesson Packaging Services a business unit of McKesson Corporation TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV E 20171231 63739-672_cf05b0a3-c94b-4d36-bff2-0eb4cd0b3b74 63739-672 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 McKesson Packaging Serivces a business unit of McKesson Corporation IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63739-673_8c98555b-2931-4e6b-b155-1e6525cb263d 63739-673 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 McKesson Packaging Services a business unit of McKesson Corp LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63739-674_85219ef9-d2ff-4037-b398-fae5e277ed4e 63739-674 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20140429 ANDA ANDA074112 McKesson Packaging Services a business unit of McKesson Corporation ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-675_81437733-9a56-42b3-ab28-fb58bfbb0f9d 63739-675 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63739-677_1de66e94-0669-4098-90d6-4c62ef5f114d 63739-677 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 McKesson Packaging Services a business unit of McKesson Corporation QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 63739-678_a194a249-4e2f-431b-8bf0-62c5355b04b6 63739-678 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET ORAL 20110531 ANDA ANDA090290 McKesson Packaging Services a business unit of McKesson Corporation DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 63739-682_06c03569-ba13-436d-97bc-df7285652330 63739-682 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 McKesson Packaging Services a business unit of McKesson Corporation ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 63739-684_cf05b0a3-c94b-4d36-bff2-0eb4cd0b3b74 63739-684 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 McKesson Packaging Serivces a business unit of McKesson Corporation IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63739-686_8c98555b-2931-4e6b-b155-1e6525cb263d 63739-686 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 McKesson Packaging Services a business unit of McKesson Corp LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63739-689_81437733-9a56-42b3-ab28-fb58bfbb0f9d 63739-689 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63739-690_1de66e94-0669-4098-90d6-4c62ef5f114d 63739-690 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130405 ANDA ANDA078679 McKesson Packaging Services a business unit of McKesson Corporation QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] E 20171231 63739-691_cf05b0a3-c94b-4d36-bff2-0eb4cd0b3b74 63739-691 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 McKesson Packaging Serivces a business unit of McKesson Corporation IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63739-693_81437733-9a56-42b3-ab28-fb58bfbb0f9d 63739-693 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63739-694_68afe518-0c35-40ea-8914-95884d9d52f4 63739-694 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION OROPHARYNGEAL 20070227 ANDA ANDA040708 McKesson Packaging Services a business unit of McKesson Corporation LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 63739-698_aefb7fb6-c89e-4804-a637-3555293bac3e 63739-698 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 McKesson Packaging Services LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 63739-700_b689fdfb-2f5c-4578-a7ee-c165a4080716 63739-700 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 McKesson Packaging Services a business unit of McKesson Corporation CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 63739-701_00902c8f-9490-4a30-8028-0216725420f9 63739-701 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 McKesson Packaging Services a business unit of McKesson Corporation MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63739-702_b1b95f77-fc91-4491-870f-7b44569f0304 63739-702 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 McKesson Packaging Services a business unit of McKesson Corporation METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 63739-704_107033c5-679b-487c-aa33-49e8c35c6419 63739-704 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20111101 ANDA ANDA040655 McKesson Packaging Services a business unit of McKesson Corproration HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 63739-706_c691700a-6ed3-455f-beee-e609f9cc2afd 63739-706 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 McKesson Packing Services a business of McKesson Corporation BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 63739-707_b44ed845-e662-4ebb-8cf5-462baa98b406 63739-707 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20111212 ANDA ANDA200265 McKesson Packaging Services a business unit of McKesson Corporation VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 63739-708_c7b19ac4-b6c6-48f4-8bd4-41fbb3246df6 63739-708 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 McKesson Packaging Services a business unit of McKesson Corporation GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 63739-709_91b641e0-4e89-41c0-9696-b961d79783c8 63739-709 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 McKesson Packaging Services a business unit of McKesson Corporation OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63739-714_7f9c5f63-760b-43d5-997a-ae043870453e 63739-714 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040322 ANDA ANDA075932 McKesson Packaging Services a busines unit of McKeson Corporation BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 63739-726_1c776dce-7d92-4aa8-b558-89feb537baf6 63739-726 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20150709 ANDA ANDA076720 McKesson Corporation MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 63739-739_b3095947-76b0-48c9-9021-b69667c47b15 63739-739 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120117 ANDA ANDA202677 McKesson Corporation OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 63739-777_b47e12d3-0395-4462-b856-2ecb033f11e6 63739-777 HUMAN PRESCRIPTION DRUG Hydroxychloroquine sulfate Hydroxychloroquine sulfate TABLET, FILM COATED ORAL 20080103 ANDA ANDA040657 McKesson Packaging Services a business unit of McKesson Corporation HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] E 20171231 63739-787_ae31074f-4d5e-4e01-9aef-3abbe711a0d8 63739-787 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 McKesson Packaging Services a business unit of McKesson Corporation LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63739-791_55a7ddc9-d358-4441-b214-d819d83e1b47 63739-791 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA078439 McKesson Packaging Services a business unit of McKesson Corporation HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 63739-795_ae31074f-4d5e-4e01-9aef-3abbe711a0d8 63739-795 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 McKesson Packaging Services a business unit of McKesson Corporation LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 63739-796_a53ef63e-7503-46e2-978f-cc49180b508a 63739-796 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20091116 ANDA ANDA078253 McKesson Corporation ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 63739-797_18855589-5063-484f-a064-cb1110833302 63739-797 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE, LIQUID FILLED ORAL 20150101 ANDA ANDA090103 McKesson Packaging Services a business unit of McKesson Corporation NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63739-800_24845e58-5bfe-4a74-beec-696a564fb68c 63739-800 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20110701 ANDA ANDA074514 McKesson Packaging Services a business unit of McKesson Corporation DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63739-801_88a7a828-f3f6-4b10-bb24-60903d5b5579 63739-801 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20110701 ANDA ANDA089160 McKesson Packaging Services a business unit of McKesson Corporation HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 63739-802_a53ee482-0e0c-4e68-9a07-26a3c0ddec35 63739-802 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110701 ANDA ANDA078203 McKesson Packaging Services a business unit of McKesson Corporation LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-803_a53ee482-0e0c-4e68-9a07-26a3c0ddec35 63739-803 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110701 ANDA ANDA078203 McKesson Packaging Services a business unit of McKesson Corporation LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-804_a53ee482-0e0c-4e68-9a07-26a3c0ddec35 63739-804 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110701 ANDA ANDA078203 McKesson Packaging Services a business unit of McKesson Corporation LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 63739-805_75f6811d-0906-4ed4-8619-eb3eed103d9b 63739-805 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20110701 ANDA ANDA077899 McKesson Packaging Servives a business unit of McKesson Corporation NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 63739-811_acbaeb6c-1198-4d11-8016-e8b6dcbbc5d9 63739-811 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130220 ANDA ANDA078801 McKesson Packaging Services a business unit of McKesson Corporation TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 63739-877_872cb75f-0414-42ab-915e-9ddd96d1f6a4 63739-877 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 McKesson Corporation TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 63739-888_0fd6b3a7-45d4-4609-aa7c-dbd41a027a22 63739-888 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 McKesson Packaging Services a business unit of McKesson Corporation PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63739-899_1c776dce-7d92-4aa8-b558-89feb537baf6 63739-899 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20150709 ANDA ANDA076733 McKesson Corporation MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 63739-900_603e9307-361f-42d2-9263-dc5f5b267028 63739-900 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA202732 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63739-901_84bd38d6-15e1-4e69-b9c6-5ae0a4d87160 63739-901 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA202733 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63739-920_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-920 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA202957 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63739-931_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-931 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA202957 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63739-932_d0cd1191-df76-4b7f-9518-e5f941c347a7 63739-932 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION INTRAVENOUS 20130515 NDA NDA201195 McKesson Packaging Services a business unit of McKesson Corporation DOCETAXEL ANHYDROUS 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] E 20171231 63739-942_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-942 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA202957 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 1000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63739-943_27784d20-a48e-44cc-942e-a7806e79056a 63739-943 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961111 ANDA ANDA070848 McKesson Packaging Services a business unit of McKesson Corporation SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] E 20171231 63739-953_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-953 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA202957 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63739-963_0fd6b3a7-45d4-4609-aa7c-dbd41a027a22 63739-963 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 McKesson Packaging Services a business unit of McKesson Corporation PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 63739-964_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-964 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA203198 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63739-971_d0cd1191-df76-4b7f-9518-e5f941c347a7 63739-971 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION, SOLUTION INTRAVENOUS 20120701 NDA NDA201195 McKesson Packaging Services a business unit of McKesson Corporation DOCETAXEL ANHYDROUS 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] E 20171231 63739-974_45314bb7-91e5-4cd4-b38a-83097812e6a9 63739-974 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20051201 ANDA ANDA077241 McKesson Packaging Services a business unit of McKesson Corporation BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 63739-975_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-975 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA203198 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 10000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63739-984_03017ff1-5fc4-42e6-a66c-681bc27b009f 63739-984 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 McKesson Packaging Services a business unit of McKesson Corporation GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 63739-986_861acd7a-4ca8-4717-afe3-71a14a8ffe01 63739-986 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20140612 ANDA ANDA203198 McKesson Packaging Services Business Unit of McKesson Corporation HEPARIN SODIUM 20000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 63739-988_aa071e67-1bf0-4746-af4c-847261f6d910 63739-988 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 McKesson Packaging Services a business unit of McKesson Corporation ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 63739-999_c7b19ac4-b6c6-48f4-8bd4-41fbb3246df6 63739-999 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 McKesson Packaging Services a business unit of McKesson Corporation GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 63742-001_2734a77a-249d-3780-e054-00144ff88e88 63742-001 HUMAN OTC DRUG Numb Master LIDOCAINE CREAM TOPICAL 20151218 OTC MONOGRAPH FINAL part346 Clinical Resolution Laboratory, Inc. LIDOCAINE 5 mg/g N 20181231 63742-001_3fd4a3fb-6ae3-4029-83d7-cd5192668be4 63742-001 HUMAN OTC DRUG NUMB MASTER Topical Anesthetic LIDOCAINE CREAM TOPICAL 20140424 OTC MONOGRAPH FINAL part346 Clinical Resolution Laboratory, Inc. LIDOCAINE 5 g/100g N 20181231 63742-002_2734a77a-248e-3780-e054-00144ff88e88 63742-002 HUMAN OTC DRUG Numb 520 LIDOCAINE CREAM TOPICAL 20151218 OTC MONOGRAPH FINAL part346 Clinical Resolution Laboratory, Inc. LIDOCAINE 5 mg/g N 20181231 63742-003_35b85131-51dc-399f-e054-00144ff8d46c 63742-003 HUMAN OTC DRUG Numb 100 LIDOCAINE CREAM TOPICAL 20160618 OTC MONOGRAPH FINAL part346 Clinical Resolution Laboratory, Inc. LIDOCAINE 50 mg/g N 20181231 63742-004_6314e1de-c557-43f4-e053-2991aa0a0d10 63742-004 HUMAN OTC DRUG Numb Soothe Lidocaine CREAM TOPICAL 20180101 OTC MONOGRAPH FINAL part346 Clinical Resolution Laboratory, Inc. LIDOCAINE 50 mg/g N 20191231 63755-0001_b1ef2cae-fd59-43fd-9b99-bc8072bb9dce 63755-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19971106 UNAPPROVED MEDICAL GAS Fleming County Hospital Home Medical Equipment OXYGEN 99 L/100L E 20171231 63759-0003_aa9df125-bf25-4ac9-a339-a0e6638be29c 63759-0003 HUMAN PRESCRIPTION DRUG AZACITIDINE azacitidine for INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20161205 ANDA ANDA207518 Shilpa Medicare Limited AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 63759-3000_35f3619e-3301-4410-8de1-33ae333b56d5 63759-3000 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20161231 ANDA ANDA207456 Shilpa Medicare Limited CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 63759-3001_35f3619e-3301-4410-8de1-33ae333b56d5 63759-3001 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20161231 ANDA ANDA207456 Shilpa Medicare Limited CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 63763-515_5f70b47c-f1a5-447e-bba7-8c74cfe64cf5 63763-515 HUMAN OTC DRUG LUCASOL Hand Instant Hand Sanitizer ethanol GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Lucas Products Corporation ETHANOL 600 mL/1000mL E 20171231 63766-001_171ffb4b-5819-4ff2-b2fa-2cf1817020d4 63766-001 HUMAN OTC DRUG KERACARE Menthol 1% GEL, DENTIFRICE TOPICAL 20140406 OTC MONOGRAPH NOT FINAL part348 Avlon Industries, Inc. MENTHOL 10 mg/g N 20181231 63766-002_1e16f39d-d2b3-43c9-b427-09b5f37a82a2 63766-002 HUMAN OTC DRUG KeraCare Dry and Itchy Scalp Anti-Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20090618 OTC MONOGRAPH FINAL part358H Avlon Industries, Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 63766-003_7c432655-ce84-4bcf-ab66-771700061709 63766-003 HUMAN OTC DRUG KeraCare Dry and Itchy Scalp Anti-Dandruff Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20090618 OTC MONOGRAPH FINAL part358H Avlon Industries, Inc. PYRITHIONE ZINC 10 mg/mL N 20181231 63766-004_69bf4874-b339-4bee-a032-8f37123c8764 63766-004 HUMAN OTC DRUG KeraCare Dry and Itchy Scalp Anti-Dandruff Pyrithione Zinc LOTION TOPICAL 20090618 OTC MONOGRAPH FINAL part358H Avlon Industries, Inc. PYRITHIONE ZINC 2 mg/mL N 20181231 63776-027_2395897b-1f1b-4666-ab44-9b891fbf6cea 63776-027 HUMAN OTC DRUG Aller Balance choline chloride, bos taurus adrenal gland, sus scrofa adrenal gland, epinephrine, onion, ammonium carbonate, apis mellifera, arsenic trioxide, histamine, interferon gamma-1a, interleukin-12 human, manganese gluconate, luffa operculata fruit, sus scrofa lung, beef lung, sus scrofa nasal mucosa, bos taurus nasal mucosa, sodium chloride, bos taurus peyers patch, sus scrofa peyers patch, schoenocaulon officinale seed, serotonin, bos taurus thymus, sus scrofa thymus SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED CHOLINE CHLORIDE; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; EPINEPHRINE; ONION; AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; MANGANESE GLUCONATE; LUFFA OPERCULATA FRUIT; SUS SCROFA LUNG; BEEF LUNG; SUS SCROFA NASAL MUCOSA; BOS TAURUS NASAL MUCOSA; SODIUM CHLORIDE; BOS TAURUS PEYER'S PATCH; SUS SCROFA PEYER'S PATCH; SCHOENOCAULON OFFICINALE SEED; SEROTONIN; BOS TAURUS THYMUS; SUS SCROFA THYMUS 200; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 4; 30; 200; 200; 200; 200; 200; 30; 30; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-033_c2e729bd-ff9d-4368-87eb-4a14fd58837c 63776-033 HUMAN OTC DRUG ANS/CNS choline chloride, epinephrine, .gamma.-aminobutyric acid, histamine, goldenseal, norepinephrine, taraxacum palustre root, tyramine SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED CHOLINE CHLORIDE; EPINEPHRINE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE; GOLDENSEAL; NOREPINEPHRINE; TARAXACUM PALUSTRE ROOT; TYRAMINE 200; 200; 200; 200; 3; 200; 30; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-035_b5d2533f-b56f-5019-5487-ff8454ead7eb 63776-035 HUMAN OTC DRUG Arthros anti-interleukin-1.alpha. immunoglobulin g rabbit, .alpha.-ketoglutaric acid, .alpha.-lipoic acid, apomorphine, bos taurus joint capsule, sus scrofa joint capsule, ascorbic acid, bos taurus adrenal gland, sus scrofa adrenal gland, brain-derived neurotrophic factor human, metenkefalin, ersofermin, bos taurus solar plexus, sus scrofa solar plexus, calcitonin, bos taurus cartilage, sus scrofa cartilage, colchicum autumnale bulb, pork collagen, bos taurus red blood cell, sus scrofa red blood cell SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; APOMORPHINE; BOS TAURUS JOINT CAPSULE; SUS SCROFA JOINT CAPSULE; ASCORBIC ACID; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; METENKEFALIN; ERSOFERMIN; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; CALCITONIN; BOS TAURUS CARTILAGE; SUS SCROFA CARTILAGE; COLCHICUM AUTUMNALE BULB; PORK COLLAGEN; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; EDODEKIN ALFA; INTERFERON GAMMA-1A; BEEF LIVER; PORK LIVER; BOS TAURUS LYMPH; SUS SCROFA LYMPH; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; NADIDE; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS PLACENTA; QUINHYDRONE; SULFUR; BOS TAURUS VEIN; SUS SCROFA VEIN 200; 30; 30; 30; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 30; 30; 30; 30 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL E 20171231 63776-037_90d22de7-bd8f-eb46-06af-e970b0b5b81a 63776-037 HUMAN OTC DRUG Articula anti-interleukin-1.alpha. immunoglobulin g rabbit, bos taurus ankle joint, sus scrofa ankle joint, metenkefalin, ersofermin, bos taurus achilles tendon, sus scrofa achilles tendon, bos taurus hip joint, sus scrofa hip joint, bos taurus knee joint, sus scrofa knee joint, beef liver, pork liver, transforming growth factor beta-1, avotermin SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; BOS TAURUS ANKLE JOINT; SUS SCROFA ANKLE JOINT; METENKEFALIN; ERSOFERMIN; BOS TAURUS ACHILLES TENDON; SUS SCROFA ACHILLES TENDON; BOS TAURUS HIP JOINT; SUS SCROFA HIP JOINT; BOS TAURUS KNEE JOINT; SUS SCROFA KNEE JOINT; BEEF LIVER; PORK LIVER; TRANSFORMING GROWTH FACTOR BETA-1; AVOTERMIN 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30; 30 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL E 20171231 63776-039_ca4226ac-eda1-47d8-a6d1-e4f19157f661 63776-039 HUMAN OTC DRUG ANS/CNS choline chloride, epinephrine, .gamma.-aminobutyric acid, histamine, goldenseal, norepinephrine, taraxacum palustre root, tyramine SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED CHOLINE CHLORIDE; EPINEPHRINE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE; GOLDENSEAL; NOREPINEPHRINE; TARAXACUM PALUSTRE ROOT; TYRAMINE 200; 200; 200; 200; 3; 200; 30; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-073_ac623381-354a-4510-9c50-3290b2959cff 63776-073 HUMAN OTC DRUG Candida ammoniac, aspergillus niger var. niger, caffeic acid, candida albicans, candida parapsilosis, ipecac, lycopodium clavatum spore, yeast mannan, vaccinium vitis-idaea leaf SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; YEAST MANNAN; VACCINIUM VITIS-IDAEA LEAF 200; 200; 200; 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-075_a942e8d0-e96c-41e4-a522-f9a18a2d47f0 63776-075 HUMAN OTC DRUG Candida I caffeic acid, candida albicans, tanacetum parthenium, centella asiatica, yeast mannan, penicillin g, vaccinium vitis-idaea leaf spray SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED CAFFEIC ACID; CANDIDA ALBICANS; TANACETUM PARTHENIUM; CENTELLA ASIATICA; YEAST MANNAN; VACCINIUM VITIS-IDAEA LEAF 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-078_b4f7ecd8-dea0-4afd-8a31-1e1aec34ad35 63776-078 HUMAN OTC DRUG Candida I caffeic acid, candida albicans, tanacetum parthenium, centella asiatica, yeast mannan, vaccinium vitis-idaea leaf spray SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED CAFFEIC ACID; CANDIDA ALBICANS; TANACETUM PARTHENIUM; CENTELLA ASIATICA; YEAST MANNAN; VACCINIUM VITIS-IDAEA LEAF 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-095_e58c27cf-8d1a-4de9-ad22-df4173a37a94 63776-095 HUMAN OTC DRUG Collagen Pork Collagen SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED PORK COLLAGEN 200 [kp_C]/mL N 20191231 63776-100_295d702c-e0bc-4b95-b571-50c9d5395c3c 63776-100 HUMAN OTC DRUG Connectissue anti-interleukin-1.alpha. immunoglobulin g rabbit, ascorbic acid, metenkefalin, ersofermin, bos taurus cartilage, sus scrofa cartilage, pork collagen, bos taurus red blood cell, sus scrofa red blood cell, interleukin-3, interleukin-3, beef liver, pork liver, beef, pork, bos taurus tendon, sus scrofa tendon, cetermin SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ASCORBIC ACID; METENKEFALIN; ERSOFERMIN; BOS TAURUS CARTILAGE; SUS SCROFA CARTILAGE; PORK COLLAGEN; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; INTERLEUKIN-3; BEEF LIVER; PORK LIVER; BEEF; PORK; BOS TAURUS TENDON; SUS SCROFA TENDON; CETERMIN 200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-165_281d9d42-cfeb-46c5-a89e-a05fd9b8236d 63776-165 HUMAN OTC DRUG Foods activated charcoal, ageratina aromatica root, ferrous iodide, gelsemium sempervirens root, calcium sulfide, histamine, interleukin-12 human, interferon gamma-1a, iodine, potassium gluconate, lycopodium clavatum spore, cajuput oil, black currant, rosa canina fruit, serotonin, xanthine, almond, apple, banana, barley, bean, beef, cashew, casein, emmental cultured, casein, lactococcus lactis cultured, casein, lactococcus lactis cultured aged, casein, lactococcus lactis cultured SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACTIVATED CHARCOAL; AGERATINA AROMATICA ROOT; FERROUS IODIDE; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; HISTAMINE; INTERLEUKIN-12 HUMAN; INTERFERON GAMMA-1A; IODINE; POTASSIUM GLUCONATE; LYCOPODIUM CLAVATUM SPORE; CAJUPUT OIL; BLACK CURRANT; ROSA CANINA FRUIT; SEROTONIN; XANTHINE; ALMOND; APPLE; BANANA; BARLEY; BEAN; BEEF; CASHEW; CASEIN, EMMENTAL CULTURED; CASEIN, LACTOCOCCUS LACTIS CULTURED; CASEIN, LACTOCOCCUS LACTIS CULTURED, AGED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM CAMEMBERTI CULTURED, AGED; CHICKEN; COCOA; COCONUT; COD, UNSPECIFIED; COFFEE BEAN; COTTON FIBER; COTTON SEED; ARCHED SWIMMING CRAB, COOKED; BLUE CRAB; DUNGENESS CRAB, COOKED; SERRATED SWIMMING CRAB, COOKED; SNOW CRAB, UNSPECIFIED; EGG; EGGPLANT; FLAX SEED; WHEAT GLUTEN; GREEN BELL PEPPER; HAZELNUT, UNSPECIFIED; LAMB; COW MILK; ONION; ORANGE; OYSTER, UNSPECIFIED; PEANUT; PECAN; PORK; POTATO; BROWN RICE; STARCH, RICE; WHITE RICE; SALMON, UNSPECIFIED; SHRIMP, UNSPECIFIED; STRAWBERRY; SOYBEAN; TEA LEAF; TOMATO; TUNA, UNSPECIFIED; ENGLISH WALNUT; WHEAT 30; 30; 30; 30; 30; 30; 200; 200; 30; 30; 30; 30; 1; 1; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-170_485b8d4e-c594-41d5-935f-e20f1ab46aff 63776-170 HUMAN OTC DRUG Female bos taurus adrenal gland, sus scrofa adrenal gland, cholesterol, sus scrofa corpus luteum, esterified estrogen, bos taurus hypothalamus, sus scrofa hypothalamus, melatonin, bos taurus ovary, sus scrofa ovary, bos taurus pancreas, sus scrofa pancreas, bos taurus pineal gland, sus scrofa pineal gland, bos taurus pituitary gland, sus scrofa pituitary gland, progesterone, sus scrofa thalamus, bos taurus thymus, sus scrofa thymus, thyroid bovine, thyroid porcine SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; CHOLESTEROL; SUS SCROFA CORPUS LUTEUM; ESTROGENS, ESTERIFIED; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; MELATONIN; BOS TAURUS OVARY; SUS SCROFA OVARY; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS PINEAL GLAND; SUS SCROFA PINEAL GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; PROGESTERONE; SUS SCROFA THALAMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-171_bd0a6e77-65a4-40d7-9174-58c721c47a29 63776-171 HUMAN OTC DRUG Female bos taurus adrenal gland, sus scrofa adrenal gland, cholesterol, sus scrofa corpus luteum, esterified estrogen, bos taurus hypothalamus, sus scrofa hypothalamus, melatonin, bos taurus ovary, sus scrofa ovary, bos taurus pancreas, sus scrofa pancreas, bos taurus pineal gland, sus scrofa pineal gland, bos taurus pituitary gland, sus scrofa pituitary gland, progesterone, sus scrofa thalamus, bos taurus thymus, sus scrofa thymus, thyroid bovine, thyroid porcine SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; CHOLESTEROL; SUS SCROFA CORPUS LUTEUM; ESTROGENS, ESTERIFIED; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; MELATONIN; BOS TAURUS OVARY; SUS SCROFA OVARY; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS PINEAL GLAND; SUS SCROFA PINEAL GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; PROGESTERONE; SUS SCROFA THALAMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-244_9fa9ddd2-f9f1-4aa0-b5e7-ed012d54fa7e 63776-244 HUMAN OTC DRUG Immunexx bos taurus adrenal gland, sus scrofa adrenal gland, ascorbic acid, bos taurus bone marrow, sus scrofa bone marrow, bos taurus red blood cell, sus scrofa red blood cell, filgrastim, aldesleukin, interferon gamma-1a, bos taurus lymph, sus scrofa lymph, bos taurus peyers patches, sus scrofa small intestine mucosa lymph follicle, bos taurus thymus, sus scrofa thymus SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ASCORBIC ACID; BOS TAURUS BONE MARROW; SUS SCROFA BONE MARROW; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; FILGRASTIM; ALDESLEUKIN; INTERFERON GAMMA-1A; BOS TAURUS LYMPH; SUS SCROFA LYMPH; BOS TAURUS PEYER'S PATCH; SUS SCROFA PEYER'S PATCH; BOS TAURUS THYMUS; SUS SCROFA THYMUS 200; 200; 30; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-249_bb80de66-c4dd-48c9-8da9-0f20d64b7152 63776-249 HUMAN OTC DRUG Infla aconitum napellus, anti-interleukin-1.alpha. immunoglobulin g rabbit, apis mellifera, bos taurus adrenal gland, sus scrofa adrenal gland, atropa belladonna, metenkefalin, citric acid monohydrate, bos taurus solar plexus, sus scrofa solar plexus, bryonia alba root, interleukin-10, bos taurus mesenchyme, sus scrofa mesenchyme, sodium pyruvate, bos taurus pineal gland, sus scrofa pineal gland, bos taurus pituitary gland, sus scrofa pituitary gland, rancid beef, transforming growth factor beta-1, avotermin SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACONITUM NAPELLUS; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APIS MELLIFERA; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ATROPA BELLADONNA; METENKEFALIN; CITRIC ACID MONOHYDRATE; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; BRYONIA ALBA ROOT; INTERLEUKIN-10; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; SODIUM PYRUVATE; BOS TAURUS PINEAL GLAND; SUS SCROFA PINEAL GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; RANCID BEEF; TRANSFORMING GROWTH FACTOR BETA-1; AVOTERMIN 200; 30; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 200; 200; 30; 30; 30; 200; 200; 200; 30; 30 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-250_5512f2f9-56a5-4b2c-be6c-052e68cddcd5 63776-250 HUMAN OTC DRUG Intra-cell ingredients SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACETYLCARNITINE; .ALPHA.-LIPOIC ACID; ASCORBIC ACID; ADENOSINE TRIPHOSPHATE; CALCIUM GLUCONATE; CITRIC ACID MONOHYDRATE; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; UBIDECARENONE; CUPRIC SULFATE; FERRIC CHLORIDE HEXAHYDRATE; FOLIC ACID; FUMARIC ACID; POTASSIUM ASPARTATE; LACTIC ACID; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; MANGANESE GLUCONATE; MANGANESE PHOSPHATE, DIBASIC; MERCURIUS SOLUBILIS; PYRUVALDEHYDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; NIACIN; PANTOTHENIC ACID; PHOSPHORUS; PODOPHYLLUM; QUINHYDRONE; SACCHAROMYCES CEREVISIAE RNA; SELENOMETHIONINE; SUCCINIC ACID; SULFUR; THIAMINE; CYANOCOBALAMIN; RIBOFLAVIN; PYRIDOXINE; .ALPHA.-TOCOPHEROL; ZINC GLUCONATE 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-270_3a84e0a0-ad77-4d02-b68f-43d0f311df3a 63776-270 HUMAN OTC DRUG Ithurts anti-interleukin-1.alpha. apomorphine, metenkefalin SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; METENKEFALIN 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-300_1b0d5cf0-748a-4007-a89e-ea0674254969 63776-300 HUMAN OTC DRUG Liver centaurea benedicta, silybum marianum seed, ceanothus americanus leaf, chelidonium majus, chionanthus virginicus bark, choline, bos taurus solar plexus, sus scrofa solar plexus, bos taurus duodenum, sus scrofa duodenum, fumaric acid, bos taurus gallbladder, sus scrofa gallbladder, inositol, binetrakin, potassium sulfate, beef liver, pork liver, lycopodium clavatum spore, sodium diethyl oxalacetate, sodium pyruvate, sodium sulfate, niacin, bos taurus pancreas, sus scrofa pancreas SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED CENTAUREA BENEDICTA; SILYBUM MARIANUM SEED; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHOLINE; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; BOS TAURUS DUODENUM; SUS SCROFA DUODENUM; FUMARIC ACID; BOS TAURUS GALLBLADDER; SUS SCROFA GALLBLADDER; INOSITOL; BINETRAKIN; POTASSIUM SULFATE; BEEF LIVER; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; NIACIN; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; TARAXACUM OFFICINALE; BOS TAURUS VEIN; SUS SCROFA VEIN; THIAMINE; CYANOCOBALAMIN; RIBOFLAVIN; PYRIDOXINE 30; 30; 6; 30; 6; 30; 200; 200; 30; 30; 30; 30; 30; 30; 200; 30; 200; 200; 30; 30; 30; 30; 30; 200; 200; 200; 200; 30; 30; 30; 30; 30; 30; 30 [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-310_05197962-9b91-472f-aaf1-038b8e89d69d 63776-310 HUMAN OTC DRUG Lymph 1 alcohol, fumaria officinalis flowering top, calcium sulfide, bos taurus lymph, sus scrofa lymph, pinus sylvestris leafy twig, green peppercorn, prunus spinosa flower bud, silicon dioxide, bos taurus spleen, sus scrofa spleen, sulfuric acid SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ALCOHOL; FUMARIA OFFICINALIS FLOWERING TOP; CALCIUM SULFIDE; POTASSIUM CARBONATE; BOS TAURUS LYMPH; PINUS SYLVESTRIS LEAFY TWIG; SUS SCROFA LYMPH; GREEN PEPPERCORN; PRUNUS SPINOSA FLOWER BUD; SILICON DIOXIDE; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SULFURIC ACID; TILIA TOMENTOSA BUD 30; 30; 30; 30; 200; 30; 200; 30; 30; 200; 200; 200; 30; 30 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-320_0eefa24b-76b9-4442-93f7-544cc37d60c0 63776-320 HUMAN OTC DRUG Male plus bos taurus adrenal gland, sus scrofa adrenal gland, aldosterone, androsterone, adenosine cyclic 3,5-phosphate, cholesterol, prasterone, somatropin, bos taurus hypothalamus, sus scrofa hypothalamus, melatonin, bos taurus pancreas, sus scrofa pancreas, bos taurus pineal gland, sus scrofa pineal gland, bos taurus pituitary gland, sus scrofa pituitary gland, bos taurus prostate gland, sus scrofa prostate, bos taurus testicle, sus scrofa testicle, testosterone, sus scrofa thalamus SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; ALDOSTERONE; ANDROSTERONE; ADENOSINE CYCLIC PHOSPHATE; CHOLESTEROL; PRASTERONE; SOMATROPIN; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; MELATONIN; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS PINEAL GLAND; SUS SCROFA PINEAL GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS PROSTATE GLAND; SUS SCROFA PROSTATE; BOS TAURUS TESTICLE; SUS SCROFA TESTICLE; TESTOSTERONE; SUS SCROFA THALAMUS; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-347_c69962b4-0359-4f3c-8e44-0e58f178797c 63776-347 HUMAN OTC DRUG MuSkel anti-interleukin-1.alpha. immunoglobulin g rabbit, bos taurus ankle joint, sus scrofa ankle joint, bos taurus joint capsule, sus scrofa joint capsule, brain-derived neurotrophic factor human, metenkefalin, ersofermin, bos taurus solar plexus, sus scrofa solar plexus, calcitonin, bos taurus frontal lobe, sus scrofa frontal lobe, bos taurus hip joint, sus scrofa hip joint, bos taurus hippocampus, sus scrofa hippocampus, bos taurus hypothalamus, sus scrofa hypothalamus, mecasermin rinfabate SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; BOS TAURUS ANKLE JOINT; SUS SCROFA ANKLE JOINT; BOS TAURUS JOINT CAPSULE; SUS SCROFA JOINT CAPSULE; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; METENKEFALIN; ERSOFERMIN; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; CALCITONIN; BOS TAURUS FRONTAL LOBE; SUS SCROFA FRONTAL LOBE; BOS TAURUS HIP JOINT; SUS SCROFA HIP JOINT; BOS TAURUS HIPPOCAMPUS; SUS SCROFA HIPPOCAMPUS; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; MECASERMIN RINFABATE; INTERLEUKIN-10; BEEF; PORK; BOS TAURUS NERVE; SUS SCROFA NERVE; BOS TAURUS SPINAL CORD; SUS SCROFA SPINAL CORD; BOS TAURUS SYMPATHETIC NERVE; SUS SCROFA SYMPATHETIC NERVE; TRANSFORMING GROWTH FACTOR BETA-1 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-370_ae7a32eb-16f5-5b56-1c2d-efff17b6ae3b 63776-370 HUMAN OTC DRUG Neuro ingredients SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED DOPAMINE; FERROUS ARSENATE; ABRUS PRECATORIUS SEED; JUNIPERUS SABINA LEAF; LEVODOPA; MELATONIN; RUBIA TINCTORUM WHOLE; SEROTONIN; TAURINE; ANTIARIS TOXICARIA RESIN 200; 30; 30; 30; 200; 200; 1; 200; 200; 30 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL E 20171231 63776-373_0772805d-6c57-48b8-92b3-9a9bd331627b 63776-373 HUMAN OTC DRUG Neuro 3 oxitriptan, acetylcholinesterase human, choline chloride, dopamine, glutamic acid, glycine, histidine, levodopa, malvin, melanin synthetic (tyrosine, peroxide), nitric oxide, norepinephrine, octopamine, o-methyl serotonin, phenylalanine, serotonin, taurine, tryptophan, tyrosine SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED OXITRIPTAN; ACETYLCHOLINESTERASE HUMAN; CHOLINE CHLORIDE; DOPAMINE; GLUTAMIC ACID; GLYCINE; HISTIDINE; LEVODOPA; MALVIN; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); MELATONIN; NITRIC OXIDE; NOREPINEPHRINE; OCTOPAMINE; 5-METHOXYTRYPTAMINE; PHENYLALANINE; SEROTONIN; TAURINE; TRYPTOPHAN; TYROSINE 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-375_6a1b7add-ec14-444c-b040-0df998efa17d 63776-375 HUMAN OTC DRUG Neuro ingredients SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED DOPAMINE; FERROUS ARSENATE; ABRUS PRECATORIUS SEED; JUNIPERUS SABINA LEAF; LEVODOPA; MELATONIN; RUBIA TINCTORUM WHOLE; SEROTONIN; TAURINE; ANTIARIS TOXICARIA RESIN 200; 30; 30; 30; 200; 200; 3; 200; 200; 30 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20181231 63776-385_513d7f85-a8a2-438c-9a75-511ffe5cf827 63776-385 HUMAN OTC DRUG Osteosis bos taurus bone, sus scrofa bone, calcitonin, bos taurus cartilage, sus scrofa cartilage, bos taurus red blood cell, sus scrofa red blood cell, interleukin-3, bos taurus parathyroid gland, sus scrofa parathyroid gland, vitamin d SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BOS TAURUS BONE; SUS SCROFA BONE; CALCITONIN; BOS TAURUS CARTILAGE; SUS SCROFA CARTILAGE; BOS TAURUS RED BLOOD CELL; SUS SCROFA RED BLOOD CELL; INTERLEUKIN-3; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; VITAMIN D 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-400_63db25bf-30d9-26d2-5993-e885e32b012f 63776-400 HUMAN OTC DRUG Ouch anti-interleukin-1.alpha. immunoglobulin g rabbit, apomorphine, arnica montana, metenkefalin, bryonia alba root, hypericum perforatum, bos taurus hypothalamus, sus scrofa hypothalamus, bos taurus limbic system, sus scrofa limbic system, bos taurus nerve, sus scrofa nerve, bos taurus pituitary gland, sus scrofa pituitary gland SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; APOMORPHINE; ARNICA MONTANA; METENKEFALIN; METENKEFALIN; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; BOS TAURUS LIMBIC SYSTEM; BOS TAURUS LIMBIC SYSTEM; SUS SCROFA LIMBIC SYSTEM; SUS SCROFA LIMBIC SYSTEM; BOS TAURUS NERVE; BOS TAURUS NERVE; SUS SCROFA NERVE; SUS SCROFA NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND 9; 30; 8; 30; 3; 9; 30; 4; 3; 5; 5; 6; 200; 6; 200; 6; 30; 6; 30; 6; 6 [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; [hp_X]/mL; [hp_X]/mL E 20171231 63776-402_0b455e94-f7c5-4746-b5d9-5fed096be267 63776-402 HUMAN OTC DRUG Ouch anti-interleukin-1.alpha. immunoglobulin g rabbit, apomorphine, arnica montana, metenkefalin, bryonia alba root, hypericum perforatum, bos taurus hypothalamus, sus scrofa hypothalamus, bos taurus limbic system, sus scrofa limbic system, bos taurus nerve, sus scrofa nerve, bos taurus pituitary gland, sus scrofa pituitary gland SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; ARNICA MONTANA; METENKEFALIN; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM; BOS TAURUS HYPOTHALAMUS; SUS SCROFA HYPOTHALAMUS; BOS TAURUS LIMBIC SYSTEM; SUS SCROFA LIMBIC SYSTEM; BOS TAURUS NERVE; SUS SCROFA NERVE; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND 30; 30; 3; 30; 4; 3; 5; 5; 200; 200; 30; 30; 6; 6 [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 63776-415_22341119-3bcd-40d0-a905-a78a07f2dc34 63776-415 HUMAN OTC DRUG Parasites wormwood, artemisia cina pre-flowering top, amoeba proteus, fluke, unspecified, oyster shell calcium carbonate, crude, schoenocaulon officinale seed, graphite, iodine, mercuric chloride, melilotus officinalis top, teucrium marum, juglans nigra whole, quassia amara wood, spigelia marilandica root, silicon dioxide SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED WORMWOOD; ARTEMISIA CINA PRE-FLOWERING TOP; AMOEBA PROTEUS; FLUKE, UNSPECIFIED; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFICINALE SEED; GRAPHITE; IODINE; MERCURIC CHLORIDE; MELILOTUS OFFICINALIS TOP; TEUCRIUM MARUM; JUGLANS NIGRA WHOLE; QUASSIA AMARA WOOD; SPIGELIA MARILANDICA ROOT; SILICON DIOXIDE 30; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 30; 30; 30; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-449_47945aa7-841a-46b6-b9bc-758cbf10f5a6 63776-449 HUMAN OTC DRUG Radiation cadmium iodide, fucus vesiculosus, iodine, chondrus crispus, radium bromide, strontium, thyroid, bovine and thyroid, porcine SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED CADMIUM IODIDE; FUCUS VESICULOSUS; IODINE; CHONDRUS CRISPUS; RADIUM BROMIDE; STRONTIUM; THYROID, BOVINE; THYROID, PORCINE 12; 3; 12; 3; 12; 12; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-450_92a0a2d9-a0a1-4153-98f8-cbb2c7340db0 63776-450 HUMAN OTC DRUG Relief acetylcholine chloride, prunus cerasifera flower, clematis vitalba flower, histamine, impatiens glandulifera flower, helianthemum nummularium flower, serotonin, ornithogalum umbellatum SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACETYLCHOLINE CHLORIDE; PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; HISTAMINE; IMPATIENS GLANDULIFERA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; SEROTONIN; ORNITHOGALUM UMBELLATUM 200; 200; 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-451_44282335-b40c-4059-a6e1-a87ab07ebc74 63776-451 HUMAN OTC DRUG Relief plus G12 acetylcholine chloride, prunus cerasifera flower, clematis vitalba flower, interleukin-12 human, histamine, interleukin-12 human, impatiens glandulifera flower, interferon gamma-1a, helianthemum nummularium flower, serotonin, ornithogalum umbellatum SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACETYLCHOLINE CHLORIDE; PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; INTERLEUKIN-12 HUMAN; HISTAMINE; IMPATIENS GLANDULIFERA FLOWER; INTERFERON GAMMA-1A; HELIANTHEMUM NUMMULARIUM FLOWER; SEROTONIN; ORNITHOGALUM UMBELLATUM 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-453_1c24c293-cb6f-ea1f-836a-e16e7cd6852c 63776-453 HUMAN OTC DRUG Relief 3 acetylcholine chloride, histamine, serotonin SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACETYLCHOLINE CHLORIDE; HISTAMINE; SEROTONIN 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL E 20171231 63776-454_cf267a0a-8286-41f4-8cb8-59670d58483e 63776-454 HUMAN OTC DRUG Relief 3-G12 acetylcholine chloride, histamine, interferon gamma-1a, interleukin-12 human, serotonin SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACETYLCHOLINE CHLORIDE; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; SEROTONIN 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-500_b5736cdb-5ff1-033e-5c86-83881bca30db 63776-500 HUMAN OTC DRUG Systemic Detox bos taurus adrenal gland, sus scrofa adrenal gland, .alpha.-ketoglutaric acid, .alpha.-lipoic acid, ascorbic acid, berberis vulgaris root, activated charcoal, centaurea benedicta, silybum marianum seed, colchicum autumnale bulb, galium aparine, binetrakin, binetrakin, beef kidney, pork kidney, beef liver, pork liver, lycopodium clavatum spore, bos taurus lymph, sus scrofa lymph, bos taurus mesenchyme, sus scrofa mesenchyme, strychnos nux-vomica seed, taraxacum officinale, taraxacum officinale SPRAY ORAL 20120326 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; .ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ASCORBIC ACID; BERBERIS VULGARIS ROOT; ACTIVATED CHARCOAL; CENTAUREA BENEDICTA; SILYBUM MARIANUM SEED; COLCHICUM AUTUMNALE BULB; GALIUM APARINE; BINETRAKIN; BEEF KIDNEY; PORK KIDNEY; BEEF LIVER; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; BOS TAURUS LYMPH; SUS SCROFA LYMPH; BOS TAURUS MESENCHYME; SUS SCROFA MESENCHYME; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; BOS TAURUS TONSIL; SUS SCROFA TONSIL; THYROID, BOVINE; THYROID, PORCINE 30; 30; 30; 30; 30; 200; 30; 30; 30; 6; 30; 200; 200; 200; 200; 200; 6; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_C]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL E 20171231 63776-525_a3d3f9d5-5f4a-4fdb-b508-59fdd368dc8c 63776-525 HUMAN OTC DRUG Thyro bos taurus adrenal gland, sus scrofa adrenal gland, fucus vesiculosus, iodine, iridium, bos taurus parathyroid gland, sus scrofa parathyroid gland, bos taurus pituitary gland, sus scrofa pituitary gland, bos taurus spleen, sus scrofa spleen, spongia officinalis whole, bos taurus thymus, sus scrofa thymus, thyroid, bovine, thyroid, porcine, levothyroxine, liothyronine SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; FUCUS VESICULOSUS; IODINE; IRIDIUM; BOS TAURUS PARATHYROID GLAND; SUS SCROFA PARATHYROID GLAND; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; SPONGIA OFFICINALIS WHOLE; BOS TAURUS THYMUS; SUS SCROFA THYMUS; THYROID, BOVINE; THYROID, PORCINE; LEVOTHYROXINE; LIOTHYRONINE 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL N 20191231 63776-605_ada0b104-c65f-11c0-6e6d-75d07d2ccd87 63776-605 HUMAN OTC DRUG Acetaldehyde Acetaldehyde SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ACETALDEHYDE 200 {kp_C}/mL E 20171231 63776-610_1c70f977-500f-1a21-3c72-c8f2b4c97e64 63776-610 HUMAN OTC DRUG AIL-1 Anti-interleukin-1.alpha. Immunoglobulin G Rabbit SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT 30 {kp_C}/mL E 20171231 63776-628_8643ddba-4b5f-4460-bb38-d906d45e6568 63776-628 HUMAN OTC DRUG BDNF Brain-derived Neurotrophic Factor Human SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN 30 [kp_C]/mL N 20191231 63776-653_b56d6a23-6a67-4df7-b50d-28f34b0993ea 63776-653 HUMAN OTC DRUG DHEA Prasterone SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED PRASTERONE 200 [kp_C]/mL N 20191231 63776-694_b1e7f3a7-2f74-4393-e13c-c9bc539f866b 63776-694 HUMAN OTC DRUG G-12 interleukin-12 human, interferon gamma-1a SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED INTERLEUKIN-12 HUMAN; INTERFERON GAMMA-1A 200; 200 {kp_C}/mL; {kp_C}/mL E 20171231 63776-710_dff5dac3-6ffb-472b-8fd5-bcdbc5965739 63776-710 HUMAN OTC DRUG IL-10 Interleukin-10 SPRAY ORAL 20120724 UNAPPROVED HOMEOPATHIC VIATREXX BIO INCORPORATED INTERLEUKIN-10 200 [kp_C]/mL N 20191231 63777-073_507a8328-ee18-4a50-a16a-959e15407a78 63777-073 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Kinray, Inc. LORATADINE 5 mg/5mL N 20181231 63777-082_e7bfff6a-ae4d-4a6e-9f10-b53edfd198d8 63777-082 HUMAN OTC DRUG Antibiotic and Pain Relief Maximum Strength bacitracin zinc neomycin sulfate polymyxin b sulfate pramoxine hcl OINTMENT TOPICAL 20100701 OTC MONOGRAPH FINAL part333B Kinray, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g E 20171231 63777-120_5b234948-3d72-3656-e053-2a91aa0abe24 63777-120 HUMAN OTC DRUG alcohol alcohol SWAB TOPICAL 20111212 OTC MONOGRAPH FINAL part344 Kinray Inc. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 63777-204_a8253bf4-12e4-40d5-813d-592c7cb587aa 63777-204 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE ORAL; TOPICAL 20120614 OTC MONOGRAPH NOT FINAL part334 Kinray MAGNESIUM SULFATE, UNSPECIFIED 1.81 kg/100kg N 20181231 63777-217_3e9027ac-cfdd-448b-a8e3-9f9f48babd81 63777-217 HUMAN OTC DRUG bacitracin zinc, neomycin sulfate and polymyxin b sulfate bacitracin zinc, neomycin sulfate and polymyxin b sulfate OINTMENT TOPICAL 20100415 OTC MONOGRAPH FINAL part333B Kinray Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 63777-222_9d4c0af2-75b3-44a8-9f9d-da6758e04b0b 63777-222 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20100419 OTC MONOGRAPH FINAL part347 Kinray Inc. ZINC OXIDE 200 mg/g N 20181231 63777-224_1fa85348-d55e-4b27-8306-b78511ecb677 63777-224 HUMAN OTC DRUG HYDROCORTISONE ACETATE Hydrocortisone Acetate CREAM TOPICAL 20110729 OTC MONOGRAPH NOT FINAL part348 Kinray Inc. HYDROCORTISONE ACETATE 1 g/100g N 20181231 63777-231_6d8ef3b7-2add-44a0-a396-1c5a320518cb 63777-231 HUMAN OTC DRUG CLOTRIMAZOLE CLOTRIMAZOLE CREAM TOPICAL 20120111 OTC MONOGRAPH FINAL part333C Kinray Inc. CLOTRIMAZOLE 1 g/100g N 20181231 63777-247_51692f22-0b19-410b-b2d2-afddeec90bcc 63777-247 HUMAN OTC DRUG HYDROCORTISONE ACETATE Hydrocortisone Acetate OINTMENT TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part348 Kinray Inc. HYDROCORTISONE ACETATE 1 g/100g N 20181231 63777-248_51d10220-2878-43f3-bce0-d9e473ef8060 63777-248 HUMAN OTC DRUG HYDROCORTISONE Hydrocortisone CREAM TOPICAL 20170614 OTC MONOGRAPH NOT FINAL part348 Kinray Inc. HYDROCORTISONE 1 g/100g N 20181231 63777-255_f39a7cb1-2029-4ed7-8dd9-9e61beb54e81 63777-255 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 20181031 ANDA ANDA074916 Kinray Inc. IBUPROFEN 100 mg/5mL N 20181231 63777-261_f39a7cb1-2029-4ed7-8dd9-9e61beb54e81 63777-261 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 20180930 ANDA ANDA074916 Kinray Inc. IBUPROFEN 100 mg/5mL N 20181231 63777-262_f39a7cb1-2029-4ed7-8dd9-9e61beb54e81 63777-262 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 20180930 ANDA ANDA074916 Kinray Inc. IBUPROFEN 100 mg/5mL N 20181231 63777-263_f39a7cb1-2029-4ed7-8dd9-9e61beb54e81 63777-263 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 20181031 ANDA ANDA074916 Kinray Inc. IBUPROFEN 100 mg/5mL N 20181231 63777-805_3147df32-d51b-4ef3-a587-2556889cf23e 63777-805 HUMAN OTC DRUG PREFERRED PLUS PHARMACY 70% ISOPROPYL ALCOHOL WIPES ISOPROPYL ALCOHOL SWAB TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333A Kinray Inc. ISOPROPYL ALCOHOL 700 mg/mL N 20181231 63777-806_1fcf1391-a95b-4307-b989-709be2ae7374 63777-806 HUMAN OTC DRUG Preferred Plus Pharmacy 3 percent Hydrogen Peroxide Wipes HYDROGEN PEROXIDE SWAB TOPICAL 20121030 OTC MONOGRAPH NOT FINAL part333A Kinray Inc. HYDROGEN PEROXIDE 30 mg/mL N 20181231 63779-056_75d49f4b-545e-43a0-a4ab-eea93723178e 63779-056 HUMAN OTC DRUG Husky Instant Hand Sanitizer Husky Instant Hand Sanitizer SOLUTION TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part333A Canberra Corporation ALCOHOL 62 mL/100mL E 20171231 63779-340_dbbb387f-137a-43a6-a24e-5458b382b5e3 63779-340 HUMAN OTC DRUG Husky 575 Foaming Antiseptic Hand Cleaner Foaming Antiseptic Hand Cleaner SOLUTION TOPICAL 20130708 OTC MONOGRAPH NOT FINAL part333A Canberra Corporation TRICLOSAN 20.8 g/100mL E 20171231 63779-505_369a14d0-8977-471f-9e09-6b07a0e49a8c 63779-505 HUMAN OTC DRUG HUSKY 505 Antiseptic Cleanser chloroxylenol LOTION TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333 Canberra Corporation CHLOROXYLENOL 10.22 g/1000mL E 20171231 63779-510_2cc0e50c-8dc2-4005-a852-35c3c52448fa 63779-510 HUMAN OTC DRUG HUSKY 510 Anti-Microbial Food Service Hand Cleaner chloroxylenol LIQUID TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333E Canberra Corporation CHLOROXYLENOL 15.75 g/1000mL E 20171231 63779-514_18e58373-40c4-4b4c-b868-a18eadf96e52 63779-514 HUMAN OTC DRUG HUSKY 514 Non-Alcohol Foaming Instant Hand Sanitizer Husky 514 SOLUTION TOPICAL 20091116 OTC MONOGRAPH NOT FINAL part333 Canberra Corporation BENZALKONIUM CHLORIDE 1 g/1000mL E 20171231 63779-515_0206e7a2-15db-4d8c-bccf-f4e096b791cb 63779-515 HUMAN OTC DRUG HUSKY 515 Instant Hand Sanitizer ethanol GEL TOPICAL 19981028 OTC MONOGRAPH NOT FINAL part333E Canberra Corporation ALCOHOL 600 mL/L E 20171231 63779-575_e2b15f71-1e47-44fd-8b05-e85222f3417a 63779-575 HUMAN OTC DRUG HUSKY 575 Foaming Antiseptic Hand Cleaner triclosan LIQUID TOPICAL 20101011 OTC MONOGRAPH NOT FINAL part333E Canberra Corporation TRICLOSAN 3.15 g/1000mL E 20171231 63783-005_17b68de7-da38-40b2-9c30-5f46f9ef4aad 63783-005 HUMAN PRESCRIPTION DRUG KIDS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .45103 g/120g N 20181231 63783-006_17b68de7-da38-40b2-9c30-5f46f9ef4aad 63783-006 HUMAN PRESCRIPTION DRUG KIDS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g N 20181231 63783-007_17b68de7-da38-40b2-9c30-5f46f9ef4aad 63783-007 HUMAN PRESCRIPTION DRUG KIDS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g N 20181231 63783-008_17b68de7-da38-40b2-9c30-5f46f9ef4aad 63783-008 HUMAN PRESCRIPTION DRUG KIDS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g N 20181231 63783-009_17b68de7-da38-40b2-9c30-5f46f9ef4aad 63783-009 HUMAN PRESCRIPTION DRUG KIDS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g N 20181231 63783-011_f670854b-a91c-4a25-8126-c44ea8a0d816 63783-011 HUMAN PRESCRIPTION DRUG DOCTORS CHOICE STANOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .45103 g/120g N 20181231 63783-012_f670854b-a91c-4a25-8126-c44ea8a0d816 63783-012 HUMAN PRESCRIPTION DRUG DOCTORS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g N 20181231 63783-013_f670854b-a91c-4a25-8126-c44ea8a0d816 63783-013 HUMAN PRESCRIPTION DRUG DOCTORS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g N 20181231 63783-015_17b68de7-da38-40b2-9c30-5f46f9ef4aad 63783-015 HUMAN PRESCRIPTION DRUG KIDS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g N 20181231 63783-016_f670854b-a91c-4a25-8126-c44ea8a0d816 63783-016 HUMAN PRESCRIPTION DRUG DOCTORS CHOICE STANNOUS FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .451 g/120g N 20181231 63783-210_06e0288a-15ca-41cb-bc16-96a6e8e93d85 63783-210 HUMAN PRESCRIPTION DRUG GINGIMED STANNOUS FLUORIDE LIQUID ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .71034 g/120g N 20181231 63783-211_06e0288a-15ca-41cb-bc16-96a6e8e93d85 63783-211 HUMAN PRESCRIPTION DRUG GINGIMED STANNOUS FLUORIDE LIQUID ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .71034 g/120g N 20181231 63783-212_06e0288a-15ca-41cb-bc16-96a6e8e93d85 63783-212 HUMAN PRESCRIPTION DRUG GINGIMED STANNOUS FLUORIDE LIQUID ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals STANNOUS FLUORIDE .71034 g/120g N 20181231 63783-400_270d4955-1afa-42ed-a3b1-9217973b60d7 63783-400 HUMAN PRESCRIPTION DRUG ORTHO GUARD SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE .044 mL/100mL N 20181231 63783-401_270d4955-1afa-42ed-a3b1-9217973b60d7 63783-401 HUMAN PRESCRIPTION DRUG ORTHO GUARD SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE .044 mL/100mL N 20181231 63783-402_270d4955-1afa-42ed-a3b1-9217973b60d7 63783-402 HUMAN PRESCRIPTION DRUG ORTHO GUARD SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19980101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE .044 mL/100mL N 20181231 63783-403_270d4955-1afa-42ed-a3b1-9217973b60d7 63783-403 HUMAN PRESCRIPTION DRUG ORTHO GUARD SODIUM FLUORIDE GEL, DENTIFRICE ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE .044 mL/100mL N 20181231 63783-500_8c9517c6-e5fa-4989-bf1a-388a219ed9cf 63783-500 HUMAN PRESCRIPTION DRUG NEUTRAMAXX 5000 PLUS TURBO SODIUM FLUORIDE PASTE ORAL 20110901 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE 1.1 g/112g N 20181231 63783-501_08bc3e50-ef49-49ce-878d-04ae908d2a96 63783-501 HUMAN PRESCRIPTION DRUG NEUTRAMAXX 5000 TCP SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 20110801 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE 1.1 g/112g N 20181231 63783-502_f3c34cea-a4b1-4a5f-ba05-9f3481f00e56 63783-502 HUMAN PRESCRIPTION DRUG NEUTRAMAXX 5000 Tri-Calcium Phosphate SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 20110801 UNAPPROVED DRUG OTHER Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE 1.1 g/112g N 20181231 63783-504_b83f40be-0407-4612-8e31-7ad9429916a2 63783-504 HUMAN PRESCRIPTION DRUG NEUTRA MAXX 5000 SODIUM FLUORIDE GEL ORAL 19890101 OTC MONOGRAPH FINAL part355 Massco Dental A Division of Dunagin Pharmaceuticals SODIUM FLUORIDE 1.428 g/120g N 20181231 63798-696_12bad274-11f5-43b5-8965-c1fa75fdefbe 63798-696 HUMAN OTC DRUG Scent-A-Way Anti-Perspirant Extended Protection Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20110810 OTC MONOGRAPH FINAL part350 Hunter's Specialties ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g E 20171231 63798-821_465a1b13-3b95-4eef-a10b-2a478e9360e2 63798-821 HUMAN OTC DRUG Bio-Strike Antiperspirant/Deodorant ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY STICK TOPICAL 20170815 OTC MONOGRAPH FINAL part350 Hunters Specialties, Inc. ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g N 20181231 63801-107_378801d8-f855-4227-9028-eaf1128fb09d 63801-107 HUMAN PRESCRIPTION DRUG Bensal HP Salicylic Acid OINTMENT TOPICAL 19981001 UNAPPROVED DRUG OTHER SMG Pharmaceuticals, LLC SALICYLIC ACID 30 mg/g N 20181231 63824-008_6f0614c5-2493-4484-acac-add8c375d574 63824-008 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20120703 NDA NDA021282 Reckitt Benckiser LLC GUAIFENESIN 600 mg/1 N 20181231 63824-014_3dd76f84-0334-48dc-99df-3ddbc9cb0eaa 63824-014 HUMAN OTC DRUG Mucinex Fast-Max Severe Congestion and Cough dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION ORAL 20120207 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 63824-015_adf1737b-e41b-4426-b6df-fcd36056c87a 63824-015 HUMAN OTC DRUG Mucinex Fast-Max Cold, Flu and Sore Throat acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION ORAL 20120207 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; 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OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 63824-123_f3500817-50d2-4b84-afd7-9cbeaf872dc5 63824-123 HUMAN OTC DRUG Mucinex Full Force OXYMETAZOLINE HYDROCHLORIDE SOLUTION NASAL 20111020 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 63824-124_1222684a-d97b-4718-b57e-136ce0a852fb 63824-124 HUMAN OTC DRUG Mucinex Moisture Smart Oxymetazoline Hydrochloride SOLUTION NASAL 20110701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 63824-125_d46ec3e6-c1d6-4952-894f-1ccf25ba54ae 63824-125 HUMAN OTC DRUG Mucinex Full Force Oxymetazoline Hydrochloride SOLUTION NASAL 20110701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 63824-127_f146cf58-8b79-4556-aafb-64cda7171c9e 63824-127 HUMAN OTC DRUG Mucinex Sinus-Max Full Force Oxymetazoline Hydrochloride SOLUTION NASAL 20120901 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL N 20181231 63824-128_0881477b-ef20-45fc-bb68-ac06530fa800 63824-128 HUMAN OTC DRUG Mucinex Sinus-Max Full Force Oxymetazoline Hydrochloride SOLUTION NASAL 20150415 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL N 20181231 63824-160_350d558e-8f0c-48f5-aa84-21a52d7d7c1d 63824-160 HUMAN OTC DRUG Delsym Cough Relief Plus Soothing Action Dextromethorphan Hydrobromide and Menthol LOZENGE ORAL 20120701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; 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PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 200; 5; 10 mg/1; mg/1; mg/1 N 20181231 63824-196_378eba3d-6e09-41a5-bacd-00d8e0e4384d 63824-196 HUMAN OTC DRUG Mucinex Fast-Max Severe Cold Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20130315 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63824-200_7cd52933-96da-486a-94ab-25ce31b1bc55 63824-200 HUMAN OTC DRUG Mucinex Sinus-Max Pressure and Pain Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20120723 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 63824-201_ee313b6d-570b-4a51-8ff9-e16d584cc8c6 63824-201 HUMAN OTC DRUG Mucinex Sinus-Max Severe Congestion Relief Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20120723 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; 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GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 63824-211_8a43f29b-8b91-4a73-847a-8547c9675fef 63824-211 HUMAN OTC DRUG Delsym Cough Plus Cold Night Time Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride SOLUTION ORAL 20130301 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 63824-212_131b8eaa-70cb-45a7-a581-9ef481d5752c 63824-212 HUMAN OTC DRUG Childrens Delsym Cough Plus Cold Night Time Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride SOLUTION ORAL 20130318 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 63824-213_3b7a6e9e-7912-44bb-9fab-27639be48075 63824-213 HUMAN OTC DRUG Delsym Cough Plus Chest Congestion DM Dextromethorphan Hydrobromide and Guaifenesin SOLUTION ORAL 20130331 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 63824-214_fa272b1d-1342-4117-b326-06aa03202191 63824-214 HUMAN OTC DRUG Childrens Delsym Cough Plus Chest Congestion DM Dextromethorphan Hydrobromide and Guaifenesin SOLUTION ORAL 20130331 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 63824-215_84d40271-e82c-40c0-8dcc-de0eac5f42b7 63824-215 HUMAN OTC DRUG Delsym Cough Plus Cold Day Time acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION ORAL 20130331 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 63824-216_8b6a40f2-0ece-4592-b3f0-376832f11d56 63824-216 HUMAN OTC DRUG Childrens Delsym Cough Plus Cold Day Time acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION ORAL 20140401 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; 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SALICYLIC ACID 2 g/100mL N 20181231 63824-316_1ae35254-6be2-46cd-a4aa-c55330fb823c 63824-316 HUMAN OTC DRUG Clearasil Daily Clear Hydra-Blast Oil-Free Face Wash Salicylic Acid LOTION TOPICAL 20150408 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-317_ab6dc60e-f50c-44a5-8692-11f818296975 63824-317 HUMAN OTC DRUG Clearasil Daily Clear Hydra-Blast Oil-Free Face Wash Sensitive Salicylic Acid LOTION TOPICAL 20131201 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-318_3d138b80-ddcb-4745-84e6-9511541dafc4 63824-318 HUMAN OTC DRUG Clearasil Ultra Acne Clearing Scrub Salicylic Acid SOLUTION TOPICAL 20090818 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser, Inc. SALICYLIC ACID 2 mg/100mL N 20181231 63824-319_4b7d3fd1-6cc0-4411-8a3e-0ecd0a739b20 63824-319 HUMAN OTC DRUG Clearasil Daily Clear Hydra-Blast Oil-Free Salicylic Acid GEL TOPICAL 20131201 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-320_81d7ce8f-34ca-4bc6-bafa-a04fc9452c3c 63824-320 HUMAN OTC DRUG Clearasil Daily Clear Hydra-Blast Oil-Free Pads Salicylic Acid SOLUTION TOPICAL 20131201 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID .03 g/1 N 20181231 63824-321_d2a54309-6b42-4ed8-8c24-6be714eff0ab 63824-321 HUMAN OTC DRUG Clearasil Daily Clear Hydra-Blast Oil-Free Face Scrub Salicylic Acid LOTION TOPICAL 20131101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-322_9edf9b30-bc0d-4058-bc76-88bf1cc8b83a 63824-322 HUMAN OTC DRUG Clearasil Ultra 5 in 1 Pads Salicylic Acid SOLUTION TOPICAL 20140901 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID .03 g/1 N 20181231 63824-325_b3e02cc3-d11b-45c9-8c38-8ba21d577c61 63824-325 HUMAN OTC DRUG Clearasil Daily Clear Hydra-Blast Pads Salicylic Acid SOLUTION TOPICAL 20150101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID .01 g/1 N 20181231 63824-326_cea4d6dd-be3b-40eb-b5f3-6ba6871a4597 63824-326 HUMAN OTC DRUG Clearasil Ultra Rapid Action Daily Face Wash Salicylic Acid CREAM TOPICAL 20160301 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-328_8b2ccbaa-1c99-480b-aab1-0791e7d52ba7 63824-328 HUMAN OTC DRUG Clearasil Ultra Acne Clearing Gel Wash Salicylic Acid SOLUTION TOPICAL 20090820 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser, Inc. SALICYLIC ACID 2 g/100mL N 20181231 63824-332_2cdba64f-ff5b-472c-be6a-5e264918ca9c 63824-332 HUMAN OTC DRUG Clearasil Daily Clear Skin Perfect Wash Salicylic Acid SOLUTION TOPICAL 20100126 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser, Inc. SALICYLIC ACID 2 g/100mL N 20181231 63824-333_72ecd72a-362d-453f-828c-6c785494184b 63824-333 HUMAN OTC DRUG Clearasil Daily Clear Oil-Free Daily Wash Salicylic Acid GEL TOPICAL 20120801 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-334_15bce440-5bd3-4b3b-a1a5-1f75a2b9eede 63824-334 HUMAN OTC DRUG Clearasil Daily Clear Daily Pore Cleansing Pads Salicylic Acid SWAB TOPICAL 20110824 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-335_4c27804f-c0f8-4ddb-908f-8540cf6fce16 63824-335 HUMAN OTC DRUG Clearasil Daily Clear Daily Facial Scrub Salicylic Acid LOTION TOPICAL 20120629 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-338_734e6a45-e7cb-4dbc-a375-52e94b13f7f8 63824-338 HUMAN OTC DRUG Clearasil Ultra Overnight Wash Salicylic Acid SOLUTION TOPICAL 20110723 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser, Inc. SALICYLIC ACID 2 g/100mL N 20181231 63824-339_5c541c78-51a8-45db-8224-d1ff6565225f 63824-339 HUMAN OTC DRUG Clearasil Ultra Overnight Face Salicylic Acid LOTION TOPICAL 20110818 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-340_8aafb76f-11ca-4a75-b89b-dc460f29dc61 63824-340 HUMAN OTC DRUG Clearasil Ultra On-The-Go Rapid Action Wipes Salicylic Acid SOLUTION TOPICAL 20120824 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-341_257f6574-9190-4965-a6d8-b95f8779bd56 63824-341 HUMAN OTC DRUG Clearasil Ultra Rapid Action Treatment Salicylic Acid GEL TOPICAL 20110801 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100g N 20181231 63824-342_80e1b21d-bdcd-42e4-ad77-6d5efaf52ed8 63824-342 HUMAN OTC DRUG LYSOL Healthy Touch Soothing Cucumber Splash Benzethonium chloride SOLUTION TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser, LLC BENZETHONIUM CHLORIDE .13 g/100mL N 20181231 63824-343_5d1d26ac-7e66-433f-9435-a69078bb4a0b 63824-343 HUMAN OTC DRUG LYSOL Healthy Touch Cleansing Green Tea and Ginger Benzethonium chloride SOLUTION TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser, LLC BENZETHONIUM CHLORIDE .13 g/100mL N 20181231 63824-344_7463e378-0b2e-440d-be8b-fd834cb02c7d 63824-344 HUMAN OTC DRUG LYSOL Healthy Touch Refreshing Grapefruit Essence Benzethonium chloride SOLUTION TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser, LLC BENZETHONIUM CHLORIDE .13 g/100mL N 20181231 63824-345_67b4e634-2e6a-43c2-8ad8-48be417db743 63824-345 HUMAN OTC DRUG Clearasil Ultra Rapid Action Pads Salicylic Acid SOLUTION TOPICAL 20111212 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID .02 g/1 N 20181231 63824-346_de2b3f99-bb7e-4e9c-85ec-c04b1c7e9d43 63824-346 HUMAN OTC DRUG Clearasil Ultra Acne plus Marks Wash and Mask Salicylic Acid SOLUTION TOPICAL 20101015 OTC MONOGRAPH FINAL part333D Reckitt Benckiser, Inc. SALICYLIC ACID 2 g/100mL N 20181231 63824-347_2ae22202-d079-4174-a5b6-84f8b23d6b09 63824-347 HUMAN OTC DRUG Clearasil Ultra Acne Plus Marks Spot Salicylic Acid LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-348_f83d3aaf-1f53-44d6-91ab-55c91a85e6e8 63824-348 HUMAN OTC DRUG LYSOL Healthy Touch Aloe Vera And Vitamin E with Moisturizers Benzethonium chloride SOLUTION TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZETHONIUM CHLORIDE .13 g/100mL N 20181231 63824-349_cc0207f5-74f8-4c8d-9adf-e0eb2e32fb17 63824-349 HUMAN OTC DRUG LYSOL Healthy Touch Benzethonium chloride SOLUTION TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZETHONIUM CHLORIDE .13 g/100mL N 20181231 63824-350_d93cca69-dbee-40a2-b841-4bafdb19d9fc 63824-350 HUMAN OTC DRUG Clearasil Daily Clear Oil-Free Daily Face Wash Salicylic Acid LOTION TOPICAL 20120624 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-351_8c04eea2-542d-4b6b-92fa-21626911ecbf 63824-351 HUMAN OTC DRUG Clearasil Daily Clear Oil-Free Daily Face Wash Sensitive Formula Salicylic Acid LOTION TOPICAL 20120715 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-352_bbc38780-11e1-4608-8424-21ee3953116b 63824-352 HUMAN OTC DRUG Clearasil Ultra Overnight Scrub Salicylic Acid SOLUTION TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-353_f25e4d81-402c-4f93-b032-4e07085ef97e 63824-353 HUMAN OTC DRUG Clearasil Ultra Rapid Action Seal-to-Clear Salicylic Acid GEL TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-354_3bb9377a-5902-43d9-8a4d-b354f86eff13 63824-354 HUMAN OTC DRUG Clearasil Ultra Rapid Action Acne System Salicylic Acid and Benzoyl Peroxide KIT 20110101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC N 20181231 63824-355_35b73824-b08f-49fc-b6dd-c6f6ec70dfa3 63824-355 HUMAN OTC DRUG Clearasil Ultra Rapid Action Daily Wash Salicylic Acid GEL TOPICAL 20160601 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-360_654e0c48-68d0-4822-abb4-6cb5a1d3dc56 63824-360 HUMAN OTC DRUG Clearasil PerfectaWash Ultra Rapid Action Face Wash Refill - Superfruit Splash Salicylic Acid LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-361_1f8561c1-1317-4383-9d38-668e6760b0bc 63824-361 HUMAN OTC DRUG Clearasil PerfectaWash Ultra Rapid Action Face Wash Refill - Soothing Plant Extracts Salicylic Acid LOTION TOPICAL 20120101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-362_eaf06162-705f-4f85-84ba-a0558e4d3989 63824-362 HUMAN OTC DRUG Clearasil Ultra Acne System Salicylic Acid and Benzoyl Peroxide KIT 20120101 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC N 20181231 63824-380_f0433daf-6b83-43cd-ae4d-7d72e1e2653a 63824-380 HUMAN OTC DRUG Clearasil Ultra Rapid Action Daily Face Wash Salicylic Acid LOTION TOPICAL 20120701 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-381_497ecf3f-da80-42e8-8485-64db6ea5d6da 63824-381 HUMAN OTC DRUG Clearasil Ultra Rapid Action Daily Wash Salicylic Acid GEL TOPICAL 20120721 OTC MONOGRAPH NOT FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-385_7370b9df-4386-4445-a97b-14b8904724ea 63824-385 HUMAN OTC DRUG Clearasil Ultra Rapid Action Face Scrub Salicylic Acid LOTION TOPICAL 20120629 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-390_81de8eee-52ca-49a5-ab81-da04207c96b6 63824-390 HUMAN OTC DRUG Clearasil Ultra Acne plus Marks Wash and Mask Salicylic Acid LOTION TOPICAL 20110915 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 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63824-436_c9023ca5-25d0-4a23-b1a0-9f2f12cff501 63824-436 HUMAN OTC DRUG Clearasil Stubborn Acne Control 5in1 Exfoliating Wash Salicylic Acid LOTION TOPICAL 20171205 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-437_2424857f-7d85-4320-8a74-beaa88a65daa 63824-437 HUMAN OTC DRUG Clearasil Stubborn Acne Control 5in1 Concealing Treatment Benzoyl Peroxide CREAM TOPICAL 20171206 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC BENZOYL PEROXIDE 10 g/100g N 20181231 63824-438_d9096290-9088-4c27-9884-7755deca226b 63824-438 HUMAN OTC DRUG Clearasil Stubborn Acne Control 5in1 Spot Treatment Benzoyl Peroxide CREAM TOPICAL 20171206 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC BENZOYL PEROXIDE 10 g/100g N 20181231 63824-439_a636362a-684f-4add-bec7-d390e272345c 63824-439 HUMAN OTC DRUG Clearasil Stubborn Acne Control 5in1 Daily Pads Salicylic Acid CLOTH TOPICAL 20171205 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID .03 g/1 N 20181231 63824-440_56d7c855-ec2b-4df3-94f5-1dd7c8dd6b94 63824-440 HUMAN OTC DRUG Clearasil Stubborn Acne Control 5in1 One Minute Mask Salicylic Acid LOTION TOPICAL 20171205 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-441_04e93977-fccc-4d4e-8b8b-4a50ae6f11b7 63824-441 HUMAN OTC DRUG Clearasil Stubborn Acne Control 5in1 Weekly Scrub Salicylic Acid LOTION TOPICAL 20171201 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 2 g/100mL N 20181231 63824-442_e0daeeea-405c-4fba-964e-3f1005098557 63824-442 HUMAN OTC DRUG Clearasil Gentle Prevention Daily Clean Pads Salicylic Acid SOLUTION TOPICAL 20171201 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID .01 g/1 N 20181231 63824-443_0076ecf7-c000-4122-b90c-062a7f1090f3 63824-443 HUMAN OTC DRUG Clearasil Gentle Prevention Daily Clean Wash Salicylic Acid LOTION TOPICAL 20171201 OTC MONOGRAPH FINAL part333D Reckitt Benckiser LLC SALICYLIC ACID 1 g/100mL N 20181231 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TOPICAL 20130701 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-465_cc9c6315-7e29-4266-baf9-74bbde06da75 63824-465 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20121226 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-466_1ce118f9-4bc9-4c93-9d3c-f840cea63af8 63824-466 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20121226 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-467_8e10e398-bfe7-46ee-a1b0-530ecff5671a 63824-467 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20121226 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-471_859d989e-ca72-4e21-8360-fc17402b43f8 63824-471 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-472_ec254469-6a29-465b-a470-efe0b911f983 63824-472 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-473_74995139-de15-48d7-9824-554f8dc0f9c1 63824-473 HUMAN OTC DRUG Childrens Mucinex Chest Congestion Guaifenesin SOLUTION ORAL 20100622 OTC MONOGRAPH FINAL part341 Reckitt Benckiser, Inc. GUAIFENESIN 100 mg/5mL N 20181231 63824-474_949f3427-360f-49b3-879e-e32520ff97e6 63824-474 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-475_16fc64ef-e0cc-4bf8-b375-5ab3a8a0abac 63824-475 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-476_f2e71ff1-f057-4e01-b2a2-72e07f0a78b5 63824-476 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-477_6cf5d57f-fa19-4e68-93e2-4f1a19f181ef 63824-477 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride KIT 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC N 20181231 63824-478_81b449c5-d12a-4269-b632-33d64a0bc1bc 63824-478 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride KIT 20130123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC N 20181231 63824-479_c953a899-9e3c-48e8-9cf1-4eea4b9e6d1e 63824-479 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-480_e6ab0188-1881-4299-a320-3746172852dc 63824-480 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-481_05e86019-0d7b-41a5-b9fe-f5ee08adcded 63824-481 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride SOLUTION TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-482_75a2d0ba-f5f0-46c3-af46-d59f07ae8c24 63824-482 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20131201 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-483_e40d99f5-c549-4588-99c5-99ce04b48f26 63824-483 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20150123 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 63824-484_fd03bdf2-1699-4fac-a69f-05d001528368 63824-484 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20150323 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-485_dbbde9ae-12f1-4b33-b370-17f6a7247ff2 63824-485 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20151008 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-486_6e50252a-1030-4040-a0fd-138c223441fe 63824-486 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20150421 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-487_481daf2c-bf0a-4b65-9ca8-9c7b1848edf2 63824-487 HUMAN OTC DRUG Lysol Touch of Foam Benzalkonium Chloride SOLUTION TOPICAL 20150323 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-488_85a1074e-13e9-4b92-be69-fa99df4ca088 63824-488 HUMAN OTC DRUG Lysol No Touch Benzalkonium Chloride SOLUTION TOPICAL 20150507 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-489_decc13bb-186f-438f-a268-52cf8a0e29b0 63824-489 HUMAN OTC DRUG Lysol No Touch Benzalkonium Chloride SOLUTION TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 63824-492_e83b7642-66a0-4079-8642-07fea17ed9c6 63824-492 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride KIT 20150508 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC N 20181231 63824-493_bb2fc889-1e29-450e-bf9e-9340f55f1212 63824-493 HUMAN OTC DRUG Lysol No-Touch Benzalkonium Chloride KIT 20150508 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC N 20181231 63824-499_21ec0eff-5f3b-4a7d-aa3b-7fe53887a3c6 63824-499 HUMAN OTC DRUG Lysol I.C. Antimicrobial Triclosan SOLUTION TOPICAL 20041231 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC TRICLOSAN .3 g/100mL E 20171231 63824-500_f7cae03b-69a9-4c15-a745-58dc2c725d26 63824-500 HUMAN OTC DRUG Mucinex Fast-Max Night Time Cold and Flu Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride SOLUTION ORAL 20130315 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 63824-510_47fab863-8c2d-43d8-86d1-13ba8e93798d 63824-510 HUMAN OTC DRUG Mucinex Fast-Max Night Time Cold and Flu Clear and Cool ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE SOLUTION ORAL 20160701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 63824-526_839cef10-acb1-4902-9cb2-c7806bf2cdeb 63824-526 HUMAN OTC DRUG Mucinex Fast-Max Day Time Severe Cold and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20130411 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC N 20181231 63824-528_ecb8544b-0ab2-445a-9c59-7ddaee3fc52c 63824-528 HUMAN OTC DRUG Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20140509 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC N 20181231 63824-536_a895edfe-fa1f-41d4-8a8d-a581ebde8745 63824-536 HUMAN OTC DRUG Mucinex Fast-Max Congestion and Headache ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE SOLUTION ORAL 20161001 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 63824-540_d2b36921-da0a-4a55-81d4-c082c09fa06e 63824-540 HUMAN OTC DRUG Mucinex Fast-Max Severe Congestion and Cough dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride SOLUTION ORAL 20171101 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 63824-541_77ae2f1a-22ad-41fe-a231-7e1c3bccb028 63824-541 HUMAN OTC DRUG Mucinex Fast-Max Severe Congestion and Cough Clear and Cool DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20160701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 63824-542_cd7dda30-e84b-40bc-a01e-a81e8fc52cce 63824-542 HUMAN OTC DRUG Mucinex Fast-Max Cold, Flu and Sore Throat Clear and Cool ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE SOLUTION ORAL 20160701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 63824-544_fa152606-e379-41f3-941c-0532d17ccf77 63824-544 HUMAN OTC DRUG Mucinex Fast-Max Severe Congestion and Cough Clear and Cool and Mucinex Fast-Max Night Time Cold and Flu Clear and Cool Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20160701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC N 20181231 63824-545_d556a996-48c2-402f-9f66-3e474ecdd385 63824-545 HUMAN OTC DRUG Mucinex Fast-Max Congestion and Headache Clear and Cool ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE SOLUTION ORAL 20160701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 63824-546_df520d68-ba96-4e1a-ab46-8e406110a0d2 63824-546 HUMAN OTC DRUG Mucinex Fast-Max Severe Congestion and Cough Liquid Pouches DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE SOLUTION ORAL 20161201 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 63824-550_ee0a8929-02f0-44ef-87d6-c7054257978b 63824-550 HUMAN OTC DRUG Mucinex Fast-Max Night Time Cold and Flu Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20130430 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 63824-551_8833b91f-f4bd-4d85-9395-579d29afbc91 63824-551 HUMAN OTC DRUG Mucinex Fast-Max Day Time Severe Cold and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20130501 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC N 20181231 63824-555_a3ab97d4-dfe6-429d-8735-6e64d9f015c4 63824-555 HUMAN OTC DRUG Mucinex Fast-Max Day Time Severe Congestion and Cough and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Acetaminophen, and Diphenhydramine Hydrochloride KIT 20140425 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC N 20181231 63824-557_a2cba0cd-fc98-49e6-a0c4-2b8a20fbcae9 63824-557 HUMAN OTC DRUG Mucinex Fast-Max Day Time Severe Cold and Mucinex Fast-Max Night Time Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20150825 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC N 20181231 63824-558_88a9ccba-7147-47bc-ae42-98c70e23d421 63824-558 HUMAN OTC DRUG Mucinex Fast-Max Day Time Severe Congestion and Cough - Mucinex Fast-Max Night Time Cold and Flu Maximum Strength Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride KIT 20150825 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC N 20181231 63824-591_3f230d85-4887-4140-90fe-687f9462aac6 63824-591 HUMAN OTC DRUG Mucinex Fast-Max Cold, Flu and Sore Throat Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20150715 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63824-592_b9ec2d2f-4f9b-4de4-bcc9-5e10e886ff05 63824-592 HUMAN OTC DRUG Mucinex Fast-Max Severe Cold and Sinus Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20150715 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 63824-593_5795547f-e5d3-40a1-b1a8-c8dcf31e3834 63824-593 HUMAN OTC DRUG Mucinex Fast-Max Night Time Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20150715 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63824-594_117565eb-061d-45be-9814-abea005db4ef 63824-594 HUMAN OTC DRUG Mucinex Fast-Max Day Severe Cold and Night Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Guaifenesin, and Phenylephrine Hydrochloride KIT 20150715 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC N 20181231 63824-594_69a1b7a3-63f2-4347-98c5-5a5f4bff7ac3 63824-594 HUMAN OTC DRUG Mucinex Fast-Max Day Severe Cold and Night Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, and Phenylephrine Hydrochloride KIT 20150715 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC N 20181231 63824-595_a0d04ccc-5daa-4a46-8b8c-f932df70801a 63824-595 HUMAN OTC DRUG Mucinex Fast-Max Severe Cold ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20170601 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63824-599_5233ad60-3ba2-4cb9-bc96-9dec45abbcc4 63824-599 HUMAN OTC DRUG Mucinex Fast-Max Congestion and Headache Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20151127 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 63824-600_63bf8dac-4324-464f-8580-a034de88b01c 63824-600 HUMAN OTC DRUG Childrens Mucinex Night Time Multi-Symptom Cold Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride SOLUTION ORAL 20130325 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 63824-689_4c6e060f-c9fe-445a-a69b-050266446e92 63824-689 HUMAN OTC DRUG Mucinex Sinus-Max Severe Congestion Relief Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, and Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20150715 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63824-690_72842905-db8e-4af3-9e91-687e4bcfe5b6 63824-690 HUMAN OTC DRUG Mucinex Sinus - Max Day / Night Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Guaifenesin, Phenylephrine hydrochloride KIT 20150715 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC N 20181231 63824-690_815a8bbf-2bb2-4593-9834-079c60a62471 63824-690 HUMAN OTC DRUG Mucinex Sinus - Max Day / Night Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride KIT 20150715 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC N 20181231 63824-692_0a1129db-3663-45e7-bfaa-5d17784dd28a 63824-692 HUMAN OTC DRUG Mucinex Sinus-Max Severe Congestion and Pain ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20170701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 63824-693_8c7dff10-4337-48d4-9e40-225bdce74c7d 63824-693 HUMAN OTC DRUG Mucinex Sinus-Max Pressure, Pain and Cough ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20170701 OTC MONOGRAPH FINAL part341 Reckitt Benckiser LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63824-712_2fb17506-fc19-4103-90d8-a9bf0d890645 63824-712 HUMAN OTC DRUG Cepacol Sore Throat Benzocaine and Menthol LOZENGE ORAL 20130315 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 63824-713_d51a5956-27bd-4547-9a81-5c1ba95e54b3 63824-713 HUMAN OTC DRUG Cepacol Extra Strength Sore Throat cherry Benzocaine and Menthol LOZENGE ORAL 20130715 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; MENTHOL, UNSPECIFIED FORM 15; 3.6 mg/1; mg/1 N 20181231 63824-720_a821f5cd-1d1b-454f-8e49-785c4efe2cc8 63824-720 HUMAN OTC DRUG Cepacol Sore Throat Benzocaine and Menthol LOZENGE ORAL 20110804 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; MENTHOL 15; 4 mg/1; mg/1 N 20181231 63824-721_c19d7cad-7756-47e6-8bf4-006355e5b916 63824-721 HUMAN OTC DRUG Cepacol Sore Throat Benzocaine and Menthol LOZENGE ORAL 20110915 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 63824-722_ace5bb0c-aac4-4648-9040-4c0b89793e28 63824-722 HUMAN OTC DRUG Cepacol Extra Strength Sore Throat sugar free cherry Benzocaine and Menthol LOZENGE ORAL 20130715 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; MENTHOL, UNSPECIFIED FORM 15; 3.6 mg/1; mg/1 N 20181231 63824-730_859d3276-20a3-48c6-9e57-ef238b367514 63824-730 HUMAN OTC DRUG Cepacol Sore Throat Benzocaine and Menthol LOZENGE ORAL 20110804 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; MENTHOL 15; 2.6 mg/1; mg/1 N 20181231 63824-731_0423d019-362b-4e27-86e7-901c891df14d 63824-731 HUMAN OTC DRUG Cepacol Sore Throat Benzocaine and Menthol LOZENGE ORAL 20110921 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; MENTHOL 15; 2.6 mg/1; mg/1 N 20181231 63824-732_79657f5d-ebb0-4b12-a71b-085d0cb1678c 63824-732 HUMAN OTC DRUG Cepacol Extra Strength Sore Throat honey lemon Benzocaine and Menthol LOZENGE ORAL 20130715 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; MENTHOL, UNSPECIFIED FORM 15; 2.6 mg/1; mg/1 N 20181231 63824-741_45f90558-e8a2-44be-8b15-29d63d0ae82b 63824-741 HUMAN OTC DRUG Cepacol SORE THROAT AND COUGH Benzocaine and Dextromethorphan Hydrobromide LOZENGE ORAL 20110919 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20181231 63824-742_e6476e0e-ca62-4077-94bc-28006b2fdff8 63824-742 HUMAN OTC DRUG Cepacol Sore Throat and Cough Benzocaine and Dextromethorphan Hydrobromide LOZENGE ORAL 20120618 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; 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MENTHOL, UNSPECIFIED FORM 15; 20 mg/1; mg/1 N 20181231 63824-780_c5590870-5acb-41c6-a687-d39e638bfdee 63824-780 HUMAN OTC DRUG Cepacol Ultra Sore Throat Benzocaine and Glycerin SPRAY ORAL 20110503 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC BENZOCAINE; GLYCERIN 5; 33 g/100mL; g/100mL N 20181231 63824-781_1823aecf-9e1f-4029-bf89-2c454ee9a9b0 63824-781 HUMAN OTC DRUG Cepacol Sore Throat Dyclonine Hydrochloride and Glycerin LIQUID ORAL 20110520 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC DYCLONINE HYDROCHLORIDE; GLYCERIN .1; 33 g/100mL; g/100mL N 20181231 63824-790_40a4dd88-e0c8-48a4-8c95-1f843008145d 63824-790 HUMAN OTC DRUG Cepacol Antibacterial Cetylpyridinium chloride LIQUID ORAL 20110622 OTC MONOGRAPH NOT FINAL part356 Reckitt Benckiser LLC CETYLPYRIDINIUM CHLORIDE .05 g/100mL N 20181231 63824-810_fd22798e-1616-49ca-9571-33bedf6efc59 63824-810 HUMAN OTC DRUG Lanacane Maximum Strength Anti-Itch Benzethonium chloride and Benzocaine CREAM TOPICAL 20120928 OTC MONOGRAPH NOT FINAL part348 Reckitt Benckiser LLC BENZETHONIUM CHLORIDE; BENZOCAINE 2; 200 mg/g; mg/g N 20181231 63824-820_67d6b374-900a-4f4a-8334-8064bed7e5b9 63824-820 HUMAN OTC DRUG Lanacane First Aid Benzethonium chloride and Benzocaine SPRAY TOPICAL 20120619 OTC MONOGRAPH NOT FINAL part333E Reckitt Benckiser LLC BENZETHONIUM CHLORIDE; BENZOCAINE 2; 200 mg/g; mg/g N 20181231 63824-850_7569a8e4-2d3b-4792-b10b-37517d211625 63824-850 HUMAN OTC DRUG Scalpicin Maximum Strength Hydrocortisone LIQUID TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part348 Reckitt Benckiser LLC HYDROCORTISONE 1 g/100mL N 20181231 63824-851_f9d6fc0b-05d7-4449-a5c5-1fdab5282f55 63824-851 HUMAN OTC DRUG Scalpicin Anti-Itch Maximum Strength Hydrocortisone LIQUID TOPICAL 20121015 OTC MONOGRAPH NOT FINAL part348 Reckitt Benckiser LLC HYDROCORTISONE 1 g/100mL N 20181231 63824-860_43847cbc-5e15-445b-81a6-d9c7ce06d138 63824-860 HUMAN OTC DRUG Scalpicin 2 in 1 Salicylic acid LIQUID TOPICAL 20120620 OTC MONOGRAPH FINAL part358B Reckitt Benckiser LLC SALICYLIC ACID 30 mg/g N 20181231 63824-861_227b1e5c-42a5-46b3-913d-1cf25cac1ad2 63824-861 HUMAN OTC DRUG Scalpicin 2 in 1 Salicylic Acid LIQUID TOPICAL 20121001 OTC MONOGRAPH FINAL part358H Reckitt Benckiser LLC SALICYLIC ACID 3 g/100mL N 20181231 63824-900_f8e16b9a-82fc-4104-a8dd-cf28d567a0cb 63824-900 HUMAN OTC DRUG LiceMD Treatment Pyrethrum Extract and Piperonyl Butoxide GEL TOPICAL 20121101 OTC MONOGRAPH FINAL part358G Reckitt Benckiser LLC PYRETHRUM EXTRACT; PIPERONYL BUTOXIDE .33; 4 g/100mL; g/100mL N 20181231 63824-916_a2e9a7d2-9785-4145-9a3b-50ef08295afc 63824-916 HUMAN OTC DRUG Lice MD Complete Pyrethrum Extract and Piperonyl Butoxide KIT 20121101 OTC MONOGRAPH FINAL part358G Reckitt Benckiser LLC N 20181231 63824-926_b87ef385-cbb8-41ae-9cef-e4bf9af038f4 63824-926 HUMAN OTC DRUG Mucinex Allergy Fexofenadine Hydrochloride TABLET ORAL 20140102 ANDA ANDA076502 Reckitt Benckiser LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 63830-221_ba3d00b4-7f0a-4c97-9cbe-9df9150370fa 63830-221 HUMAN OTC DRUG Sani-Care ALCOHOL GEL TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333E Pro Chem, Inc. ALCOHOL .7 mL/mL N 20181231 63830-544_39de0d4a-75e6-4023-b3f6-1627bd3e6eb8 63830-544 HUMAN OTC DRUG Ban-Aid CHLOROXYLENOL SOAP TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part333E Pro Chem, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 63830-575_a0d6a916-92fe-4aca-8228-c3f97180ff3f 63830-575 HUMAN OTC DRUG Suds Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20171227 OTC MONOGRAPH NOT FINAL part333E Pro Chem, Inc. BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 63830-585_b7297bc8-31de-44dd-978e-893af63a1b4a 63830-585 HUMAN OTC DRUG Prevent ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Pro Chem, Incorporated ALCOHOL .7 mL/mL N 20181231 63830-855_7d5f6cd9-716b-4201-9a18-3dafc2ce4b52 63830-855 HUMAN OTC DRUG Prevent ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333E Pro Chem, Incorporated ALCOHOL .62 mL/mL N 20181231 63830-876_3423cebb-9b9d-4795-bd88-7c0a15c13a3a 63830-876 HUMAN OTC DRUG Suds High Foaming Antiseptic Hand and Body Wash CHLOROXYLENOL SOAP TOPICAL 20170110 OTC MONOGRAPH NOT FINAL part333E Pro chem, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 63833-386_d5957e88-7434-4e3b-a035-224e2f9fca1f 63833-386 PLASMA DERIVATIVE Kcentra PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, Protein C, Protein S Human, and Water KIT 20130429 BLA BLA125421 CSL Behring GmbH N 20181231 63833-387_d5957e88-7434-4e3b-a035-224e2f9fca1f 63833-387 PLASMA DERIVATIVE Kcentra PROTHROMBIN, COAGULATION FACTOR VII HUMAN, COAGULATION FACTOR IX HUMAN, COAGULATION FACTOR X HUMAN, Protein C, Protein S Human, and Water KIT 20131213 BLA BLA125421 CSL Behring GmbH N 20181231 63833-518_de49c0b9-377c-49ff-b0fa-26acb28318c6 63833-518 PLASMA DERIVATIVE Corifact Factor XIII Concentrate (Human) KIT 20110217 BLA BLA125385 CSL Behring GmbH N 20181231 63833-615_eef5f8f0-eb97-446b-8403-f8445b3d9b08 63833-615 PLASMA DERIVATIVE Humate-P antihemophilic factor/von willebrand factor complex (human) KIT 19860501 BLA BLA103960 CSL Behring GmbH N 20181231 63833-616_eef5f8f0-eb97-446b-8403-f8445b3d9b08 63833-616 PLASMA DERIVATIVE Humate-P antihemophilic factor/von willebrand factor complex (human) KIT 19860501 BLA BLA103960 CSL Behring GmbH N 20181231 63833-617_eef5f8f0-eb97-446b-8403-f8445b3d9b08 63833-617 PLASMA DERIVATIVE Humate-P antihemophilic factor/von willebrand factor complex (human) KIT 19860501 BLA BLA103960 CSL Behring GmbH N 20181231 63833-825_51195fb6-c945-4147-a9c2-2772c4f37470 63833-825 PLASMA DERIVATIVE Berinert HUMAN C1-ESTERASE INHIBITOR KIT 20111222 BLA BLA125287 CSL Behring GmbH N 20181231 63833-828_85ba9fdb-b5ae-45da-9cb1-d71079f84cd6 63833-828 PLASMA DERIVATIVE HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human) HUMAN C1-ESTERASE INHIBITOR KIT 20170622 BLA BLA125606 CSL Behring GmbH N 20181231 63833-829_85ba9fdb-b5ae-45da-9cb1-d71079f84cd6 63833-829 PLASMA DERIVATIVE HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human) HUMAN C1-ESTERASE INHIBITOR KIT 20170622 BLA BLA125606 CSL Behring GmbH N 20181231 63833-891_b9fd1cc1-5a93-4161-8b06-d0476209de6f 63833-891 PLASMA DERIVATIVE RiaSTAP FIBRINOGEN HUMAN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20090116 BLA BLA125317 CSL Behring GmbH FIBRINOGEN HUMAN 1300 mg/50mL Human Blood Coagulation Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient] N 20181231 63843-465_b909eca4-f8f6-4e01-920f-6360da698ab6 63843-465 HUMAN OTC DRUG FOAMING ALOEGUARD ANTIMICROBIAL CHLOROXYLENOL SOAP TOPICAL 20140623 OTC MONOGRAPH NOT FINAL part333E HealthLink CHLOROXYLENOL 2.5 g/1000mL E 20171231 63843-487_2ececabf-88d9-470c-b1eb-c923214c7fdd 63843-487 HUMAN OTC DRUG SELECT ANTISEPTIC HAND GEL WITH ALOE ALCOHOL SOAP TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part333E HealthLink ALCOHOL .62 mL/mL E 20171231 63843-509_641999dc-69eb-3527-e053-2991aa0a1369 63843-509 HUMAN OTC DRUG ALOEGUARD ANTIMICROBIAL CHLOROXYLENOL SOAP TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part333E HealthLink CHLOROXYLENOL 5 g/1000mL N 20191231 63843-520_641a01e1-f4b9-577b-e053-2a91aa0a3bcb 63843-520 HUMAN OTC DRUG GBG AloeGel Instant Hand Sanitizer Alcohol SOAP TOPICAL 20001001 OTC MONOGRAPH NOT FINAL part333E HealthLink ALCOHOL .62 mL/mL N 20191231 63843-547_9b0d188f-b17e-4ca1-a54c-1fbfb34b0477 63843-547 HUMAN OTC DRUG REGIMEN ANTIMICROBIAL CHLOROXYLENOL SOAP TOPICAL 20130924 OTC MONOGRAPH NOT FINAL part333E HealthLink CHLOROXYLENOL 5 g/1000mL E 20171231 63843-727_65f6c1af-3b18-4163-9c0d-981ee4854ea8 63843-727 HUMAN OTC DRUG GBG AloeGel ALCOHOL GEL TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part333 HealthLink ALCOHOL .7 mL/mL E 20171231 63843-729_744d492e-5d36-49cc-9037-adbf89c081f2 63843-729 HUMAN OTC DRUG AloeGuard CHLOROXYLENOL SOAP TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part333 HealthLink CHLOROXYLENOL .005 mL/mL E 20171231 63843-773_ce01b653-1be1-45d6-9661-d76f9b238e97 63843-773 HUMAN OTC DRUG GBGF ALCOHOL AEROSOL, FOAM TOPICAL 20090701 OTC MONOGRAPH NOT FINAL part333E Healthlink ALCOHOL 620 mg/g E 20171231 63843-898_219e38dc-9b49-400e-a0bf-5891dcde5700 63843-898 HUMAN OTC DRUG GBG Alcohol AEROSOL, FOAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333E HealthLink ALCOHOL .62 g/g E 20171231 63850-0021_b7e4200c-feff-4537-aad1-cf9989fd8c14 63850-0021 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20101007 ANDA ANDA091630 Natco Pharma Limited-Pharma Division TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 63850-0022_b7e4200c-feff-4537-aad1-cf9989fd8c14 63850-0022 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20101007 ANDA ANDA091630 Natco Pharma Limited-Pharma Division TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 N 20181231 63850-0053_f7121f99-b30f-4286-aac0-bc9b59eb0e59 63850-0053 HUMAN PRESCRIPTION DRUG Lacosamide Lacosamide TABLET, FILM COATED ORAL 20160528 ANDA ANDA204921 Natco Pharma Limited LACOSAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 63850-0054_f7121f99-b30f-4286-aac0-bc9b59eb0e59 63850-0054 HUMAN PRESCRIPTION DRUG Lacosamide Lacosamide TABLET, FILM COATED ORAL 20160528 ANDA ANDA204921 Natco Pharma Limited LACOSAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 63850-0055_f7121f99-b30f-4286-aac0-bc9b59eb0e59 63850-0055 HUMAN PRESCRIPTION DRUG Lacosamide Lacosamide TABLET, FILM COATED ORAL 20160528 ANDA ANDA204921 Natco Pharma Limited LACOSAMIDE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 63850-0056_f7121f99-b30f-4286-aac0-bc9b59eb0e59 63850-0056 HUMAN PRESCRIPTION DRUG Lacosamide Lacosamide TABLET, FILM COATED ORAL 20160528 ANDA ANDA204921 Natco Pharma Limited LACOSAMIDE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 63851-501_1e6d0596-d032-4f29-a94b-ca5ce32abe23 63851-501 VACCINE RabAvert Rabies Vaccine KIT 20140708 20200331 BLA BLA103334 GSK Vaccines GmbH N 20181231 63862-001_61d0cf43-faf0-2c08-e053-2a91aa0a6d62 63862-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19971107 NDA NDA205865 J & M CYLINDER GASES, INC. OXYGEN 99.5 L/L N 20191231 63862-002_61d0ed43-6518-5aa8-e053-2a91aa0ad946 63862-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19971107 NDA NDA205866 J & M CYLINDER GASES, INC. NITROGEN 99.5 L/L N 20191231 63868-002_00a77364-aad1-4d9b-b006-9260e7c22eb3 63868-002 HUMAN OTC DRUG NATURA-LAX polyethylene glycol 3350 POWDER, FOR SOLUTION ORAL 20140501 ANDA ANDA090812 Chain Drug Marketing Association POLYETHYLENE GLYCOL 3350 17 g/17g E 20171231 63868-003_06ac99ec-0f6e-61ed-e054-00144ff8d46c 63868-003 HUMAN OTC DRUG Severe Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120724 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-004_06ac99ec-0f44-61ed-e054-00144ff8d46c 63868-004 HUMAN OTC DRUG Cold and Cough ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120724 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-005_06a92a2e-9c3f-2a7c-e054-00144ff88e88 63868-005 HUMAN OTC DRUG Severe Cold Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20120724 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 63868-006_06ba032d-b5ed-115f-e054-00144ff88e88 63868-006 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Nighttime Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride KIT 20120724 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association N 20181231 63868-007_47f89d33-6e0d-4bb4-e054-00144ff88e88 63868-007 HUMAN OTC DRUG Quality Choice Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20101028 OTC MONOGRAPH FINAL part358G Quality Choice PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 63868-008_7239eecd-967c-4be3-901c-f80ce98c9af2 63868-008 HUMAN OTC DRUG Lansoprazole Heartburn Relief 24 Hour Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130430 ANDA ANDA202727 QUALITY CHOICE (Chain Drug Marketing Association) LANSOPRAZOLE 15 mg/1 N 20181231 63868-011_dd540cf3-781c-4260-aded-9540b7acb21d 63868-011 HUMAN OTC DRUG DayTime NightTime Cold/Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130115 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) N 20181231 63868-012_fd590103-7b29-4783-af34-cd3893643384 63868-012 HUMAN OTC DRUG QC Cold and Hot Pain Relief Menthol PATCH TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part348 CHAIN DRUG MARKETING ASSOCIATION INC MENTHOL 400 mg/1 E 20171231 63868-013_b10e06e9-259c-4e88-9837-b0879799d424 63868-013 HUMAN OTC DRUG Quality Choice Muscle and Joint Menthol GEL TOPICAL 20110916 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association MENTHOL 2.5 g/100g E 20171231 63868-014_ac8f2a89-b672-489c-8675-07fefd575d7a 63868-014 HUMAN OTC DRUG EZ Nite Sleep Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20130311 OTC MONOGRAPH FINAL part338 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63868-015_06ba032d-b607-115f-e054-00144ff88e88 63868-015 HUMAN OTC DRUG Cold Multi Symptom Daytime Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride KIT 20130306 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association N 20181231 63868-016_52faf008-82a7-474a-b2cd-2a2358a42c1d 63868-016 HUMAN OTC DRUG EZ Nite Sleep Diphenhydramine HCl LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 63868-020_33b1b30a-4f1d-4a73-8410-58db62bfb673 63868-020 HUMAN OTC DRUG Daytime Cold and Flu Non Drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 63868-021_4838c001-eae5-4fb5-abe3-261dc844978f 63868-021 HUMAN OTC DRUG Severe Cold and Cough Relief Daytime ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 63868-022_0d16c304-e9ad-4b12-9931-428c28e00c05 63868-022 HUMAN OTC DRUG Nighttime Cold and Flu Relief Multi-Symptom Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20151031 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 63868-024_6fc3876e-6d31-4665-aa80-787941caf6bf 63868-024 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET ORAL 20120827 ANDA ANDA079112 Chain Drug Marketing Association FEXOFENADINE HYDROCHLORIDE 180 mg/1 E 20171231 63868-025_a4109d9d-568c-3728-af04-750fd38ecd00 63868-025 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine hydrochloride TABLET ORAL 20140401 ANDA ANDA076502 Chain Drug Marketing Associate FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 63868-026_f145057a-ab68-475b-87df-a703ee3993b8 63868-026 HUMAN OTC DRUG Quality Choice Earwax Removal Kit CARBAMIDE PEROXIDE LIQUID TOPICAL 20141127 OTC MONOGRAPH FINAL part344 Chain Drug Marketing Association, Inc. CARBAMIDE PEROXIDE 65 mg/mL N 20181231 63868-029_a4305cf7-b9fa-40a5-84b7-170139f23a37 63868-029 HUMAN OTC DRUG Chewable Aspirin Low Dose Aspirin TABLET ORAL 20010904 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ASPIRIN 81 mg/1 N 20181231 63868-030_9df5519d-a59d-4945-b853-ac99b44a41e3 63868-030 HUMAN OTC DRUG Tension Headache Relief Acetaminophen, Caffeine TABLET, FILM COATED ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 63868-031_91b9fe69-295a-4af6-b436-fd3c16a2cd74 63868-031 HUMAN OTC DRUG Menstrual Pain Relief Maximum Strength, Multi-Symptom Acetaminophen, Pamabrom, Pyrilamine Maleate TABLET, FILM COATED ORAL 20000620 20190119 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 E 20171231 63868-032_7cd6c6b7-3f4a-4a7e-b05a-c9432e839bd7 63868-032 HUMAN OTC DRUG Menstrual Complete Maximum Strength Acetaminophen, Caffeine, Pyrilamine maleate TABLET, FILM COATED ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 63868-033_feed1f88-cb4b-42bf-8c1e-5872983204ff 63868-033 HUMAN OTC DRUG Rapid Melts Childrens Acetaminophen TABLET, CHEWABLE ORAL 20041206 20200921 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN 80 mg/1 N 20181231 63868-034_9555a347-705f-4748-9cbf-1771bbb05f1c 63868-034 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 CHAIN DRUG MARKETING ASSOCIATION INC DIMENHYDRINATE 50 mg/1 N 20181231 63868-036_f1f20e3d-0d16-4b94-a040-60fd6a79cd73 63868-036 HUMAN OTC DRUG Childrens Plus Cold Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCI SUSPENSION ORAL 20150331 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 63868-037_e8aa3d78-d19e-4afa-ae94-11369fc713ac 63868-037 HUMAN OTC DRUG Daytime Non Drowsy ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20151031 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 63868-040_38d12701-c14d-41b6-bac2-970d9cb7c189 63868-040 HUMAN OTC DRUG Salicylic Acid Medicated Corn Remover PATCH TOPICAL 20171218 OTC MONOGRAPH FINAL part358F Chain Drug Marketing Association SALICYLIC ACID 40 mg/91 N 20181231 63868-041_8c6b4713-2d37-4233-a7e4-98e5466b3baa 63868-041 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358F Chain Drug Marketing Association SALICYLIC ACID 40 mg/41 N 20181231 63868-042_163b0534-282b-425c-981a-205d66bc477d 63868-042 HUMAN OTC DRUG Salicylic Acid Medicated Plantar Wart Remover PATCH TOPICAL 20171218 OTC MONOGRAPH FINAL part358B Chain Drug Marketing Association SALICYLIC ACID 40 mg/241 N 20181231 63868-043_067064b2-5d0a-4a75-b714-eb1c9f93c006 63868-043 HUMAN OTC DRUG Tolnaftate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20120103 OTC MONOGRAPH FINAL part333C Chain Drug Marketing Association TOLNAFTATE 1.3 g/130g N 20181231 63868-044_f35b29e4-7fed-42e8-81be-953f8b0ee42b 63868-044 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20120103 OTC MONOGRAPH FINAL part333C Chain Drug Marketing Association MICONAZOLE NITRATE 2.6 g/130g N 20181231 63868-045_4e80c7ee-d5cb-4240-9df1-37aec82f603e 63868-045 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part333A Chain Drug Marketing Association BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/9mL; mg/9mL N 20181231 63868-046_026b8371-b4c3-47d5-a6dd-a6bcc35995b2 63868-046 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20171219 OTC MONOGRAPH FINAL part333C Chain Drug Marketing Association TOLNAFTATE 1.5 g/150g N 20181231 63868-047_13137026-5d21-4e59-ab16-0fd69d9ccc64 63868-047 HUMAN OTC DRUG Quality Choice Chewable Antacid Assorted Fruit Antacid Tablets TABLET, CHEWABLE ORAL 20140207 OTC MONOGRAPH FINAL part331 Chain Drug Marketing Association CALCIUM CARBONATE 500 mg/1 N 20181231 63868-050_438ecde6-d5b4-5971-e054-00144ff88e88 63868-050 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20150602 OTC MONOGRAPH FINAL part341 Quality Choice MENTHOL 5.4 mg/1 N 20181231 63868-051_43907f1a-4b83-5d47-e054-00144ff8d46c 63868-051 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20150602 OTC MONOGRAPH FINAL part341 Quality Choice MENTHOL 5.8 mg/1 N 20181231 63868-052_439eca07-5895-1058-e054-00144ff8d46c 63868-052 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20150602 OTC MONOGRAPH FINAL part341 Quality Choice MENTHOL 7.5 mg/1 N 20181231 63868-053_43a03032-4ee4-1b1c-e054-00144ff88e88 63868-053 HUMAN OTC DRUG SF Cherry Cough Drop Menthol LOZENGE ORAL 20150602 OTC MONOGRAPH FINAL part341 Quality Choice MENTHOL 5.8 mg/1 N 20181231 63868-054_44072586-3fd6-2543-e054-00144ff88e88 63868-054 HUMAN OTC DRUG SF Honey Lemon Cough Drop Menthol LOZENGE ORAL 20150602 OTC MONOGRAPH FINAL part341 Quality Choice MENTHOL 7.6 mg/1 N 20181231 63868-055_45364be4-615f-6576-e054-00144ff88e88 63868-055 HUMAN OTC DRUG Cherry Sore Throat Lozenge Benzocaine LOZENGE ORAL 20150708 OTC MONOGRAPH NOT FINAL part356 Quality Choice BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 63868-056_455ad355-9b83-1129-e054-00144ff88e88 63868-056 HUMAN OTC DRUG Mixed Berry Sore Throat Lozenge Benzocaine LOZENGE ORAL 20150708 OTC MONOGRAPH NOT FINAL part356 Quality Choice BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20181231 63868-057_455d4d17-5005-583b-e054-00144ff88e88 63868-057 HUMAN OTC DRUG Cherry Antacid Soft Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20150610 OTC MONOGRAPH FINAL part331 Quality Choice CALCIUM CARBONATE 1177 mg/1 N 20181231 63868-058_4cfcfb9b-6d26-3d54-e054-00144ff88e88 63868-058 HUMAN OTC DRUG cold relief zincum gluconicum LOZENGE ORAL 20150708 UNAPPROVED HOMEOPATHIC Chain Drug Marketing ZINC GLUCONATE 2 [hp_X]/1 N 20181231 63868-059_5b5bf8b3-713b-ec7b-e053-2a91aa0a74c7 63868-059 HUMAN OTC DRUG menthol cough drop Menthol LOZENGE ORAL 20171012 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association MENTHOL 5.4 mg/1 N 20181231 63868-060_602b4f63-1548-3f33-e053-2a91aa0aeb73 63868-060 HUMAN OTC DRUG Instant Antiseptic Pain Relief Camphor 10.8% and Phenol 4.7% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Chain Drug Market Association CAMPHOR (NATURAL); PHENOL 108; 47 mg/mL; mg/mL N 20181231 63868-061_5b5c6d9c-e37c-634f-e053-2a91aa0a8968 63868-061 HUMAN OTC DRUG cherry cough drops Menthol LOZENGE ORAL 20171012 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Accociation MENTHOL 5.8 mg/1 N 20181231 63868-062_5b5ce740-4116-068f-e053-2a91aa0aa2ba 63868-062 HUMAN OTC DRUG honey lemon cough drops Menthol LOZENGE ORAL 20171012 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association MENTHOL 7.5 mg/1 N 20181231 63868-064_5b607250-fdb9-5fbf-e053-2991aa0a33a6 63868-064 HUMAN OTC DRUG sugar free cherry cough drops Menthol LOZENGE ORAL 20171012 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association MENTHOL 5.8 mg/1 N 20181231 63868-065_ba70e243-bc59-48d3-9e7b-8cefa0a03258 63868-065 HUMAN OTC DRUG Cold and Cough Nighttime Cool Blast Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 1000; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 63868-066_5b724c54-74ab-cf91-e053-2991aa0a1455 63868-066 HUMAN OTC DRUG sugar free honey lemon cough drops Menthol LOZENGE ORAL 20171013 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association MENTHOL 7.6 mg/1 N 20181231 63868-067_29a4c74e-ef58-405e-b631-51aaafaa6ce7 63868-067 HUMAN OTC DRUG Daytime Flu Relief Therapy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 63868-068_0cb52bcd-e137-48dc-aa3c-dcfb7c848523 63868-068 HUMAN OTC DRUG Nighttime Cold and Flu Relief Therapy Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 63868-069_2a4bfc0f-0191-48d6-976d-809494c9566b 63868-069 HUMAN OTC DRUG Cough Relief Dextromethorphan HBr LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 63868-070_85b346a8-3a15-4803-ab47-290944977340 63868-070 HUMAN OTC DRUG Childrens Cough Relief Dextromethorphan HBr LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 63868-071_06a92a2e-9c03-2a7c-e054-00144ff88e88 63868-071 HUMAN OTC DRUG Severe Sinus Congestion and Pain ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20091113 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 63868-072_06ac9e02-95af-3046-e054-00144ff88e88 63868-072 HUMAN OTC DRUG Cold Multi Symptom Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20091113 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-073_06ac9e02-959a-3046-e054-00144ff88e88 63868-073 HUMAN OTC DRUG Severe Cold Multi Symptom ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20091113 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-074_06ac99ec-0f59-61ed-e054-00144ff8d46c 63868-074 HUMAN OTC DRUG Cold Head Congestion Nighttime ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20091113 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-075_06ba032d-b5d8-115f-e054-00144ff88e88 63868-075 HUMAN OTC DRUG Severe Cold Head Congestion Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20091113 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-076_f96e20b1-9461-4231-9278-75a9313310b5 63868-076 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION ORAL 20091101 ANDA ANDA079058 Chain Drug Marketing Association Inc. IBUPROFEN 50 mg/1.25mL N 20181231 63868-082_066f3051-0683-62ea-e054-00144ff8d46c 63868-082 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen TABLET ORAL 20140613 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 325 mg/1 N 20181231 63868-083_066f3051-0696-62ea-e054-00144ff8d46c 63868-083 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20140613 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 500 mg/1 N 20181231 63868-084_06ba7619-b3ea-70a4-e054-00144ff88e88 63868-084 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20140613 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 500 mg/1 N 20181231 63868-086_e9d59486-da46-4a23-ae13-6e0dd6434726 63868-086 HUMAN OTC DRUG Laxative Pills Maximum Strength Sennosides TABLET ORAL 20160131 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) SENNOSIDES 25 mg/1 N 20181231 63868-087_06a92a2e-9bf0-2a7c-e054-00144ff88e88 63868-087 HUMAN OTC DRUG Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20081110 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63868-088_06ba7a68-6198-25ea-e054-00144ff88e88 63868-088 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20120827 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 500 mg/1 N 20181231 63868-089_d7fb4028-7bc9-4008-b590-7c44ad73d2bc 63868-089 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Chain Drug Marketing Association Inc. ACETAMINOPHEN 650 mg/1 N 20181231 63868-090_9e7c23ef-c4cc-4408-ba45-e087b4de62ac 63868-090 HUMAN OTC DRUG Non Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130105 20181231 OTC MONOGRAPH NOT FINAL part343 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 63868-091_66ada349-e26c-493f-95dd-4ae3a2ba3c30 63868-091 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Chain Drug Marketing Association Inc. ACETAMINOPHEN 650 mg/1 N 20181231 63868-092_5241de2d-a972-4da8-a677-fdd31d7769c2 63868-092 HUMAN OTC DRUG Quality Choice Childrens Allergy Relief Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Chain Drug Marketing Association, Inc. LORATADINE 5 mg/5mL N 20181231 63868-093_f4c39cea-9a5e-45f4-bcf8-c372ef81ce86 63868-093 HUMAN OTC DRUG Quality Choice Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Chain Drug Marketing Association Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 63868-094_5fd125c7-3cfa-4970-8b9a-89f342f480f1 63868-094 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130320 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN 25; 500 mg/1; mg/1 N 20181231 63868-096_75d182e3-1039-43c8-a183-7fd4d479e0d4 63868-096 HUMAN OTC DRUG Childrens Allergy Dye Free Loratadine LIQUID ORAL 20150131 ANDA ANDA077421 QUALITY CHOICE (Chain Drug Marketing Association) LORATADINE 5 mg/5mL N 20181231 63868-097_602b4a02-abed-2204-e053-2991aa0adb0c 63868-097 HUMAN OTC DRUG Quality Choice Anti-Itch Clear Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Chain Drug Market Association ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 63868-098_825a9598-82c0-40d9-85ec-689708dbd7c8 63868-098 HUMAN OTC DRUG Ultra Strength Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20160728 OTC MONOGRAPH FINAL part332 Chain Drug Marketing Association Inc. DIMETHICONE 180 mg/1 N 20181231 63868-099_a049abe2-7cbd-4507-a390-06f5972c3d93 63868-099 HUMAN OTC DRUG Quality Choice Hydrocortisone Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association HYDROCORTISONE 1 g/100g N 20181231 63868-100_28b8ddbe-d4d0-4853-b053-6938705f1748 63868-100 HUMAN OTC DRUG QUALITY CHOICE Antibacterial Moist Towelettes BENZALKONIUM CHLORIDE CLOTH TOPICAL 20130103 OTC MONOGRAPH NOT FINAL part333A Chain Drug Marketing Association BENZALKONIUM CHLORIDE .1 g/1 N 20181231 63868-101_175c2f55-552a-4073-bbc2-3b8d2ca333b4 63868-101 HUMAN OTC DRUG Quality Choice Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20100104 UNAPPROVED DRUG OTHER Chain Drug Marketing Association PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 63868-104_602ee07d-770e-4328-e053-2991aa0ad96b 63868-104 HUMAN OTC DRUG Quality Choice Tolnaftate Antifungal TOLNAFTATE CREAM TOPICAL 20130531 OTC MONOGRAPH FINAL part333C Chain Drug Marketing Association Inc TOLNAFTATE 1 g/100g N 20181231 63868-106_c07a584b-051e-4350-a1ee-052d0e281ebc 63868-106 HUMAN OTC DRUG Quality Choice Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Chain Drug Marketing Association CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 63868-107_e561e532-fbcf-4f69-9e11-a0a70420d8a8 63868-107 HUMAN OTC DRUG All Day Allergy Relief Cetirizine HCl CAPSULE ORAL 20130303 NDA NDA022429 QUALITY CHOICE (Chain Drug Marketing Association) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 63868-109_06a826d2-da00-2dd8-e054-00144ff8d46c 63868-109 HUMAN OTC DRUG Stay Awake CAFFEINE TABLET ORAL 20140613 OTC MONOGRAPH FINAL part340 Chain Drug Marketing Association CAFFEINE 200 mg/1 N 20181231 63868-114_4ebaefc9-147d-401b-a7a4-45b07e7ef463 63868-114 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 CHAIN DRUG MARKETING ASSOCIATION INC CAFFEINE 200 mg/1 N 20181231 63868-115_bcf05d86-2aaa-4bff-98da-bc7192d12290 63868-115 HUMAN OTC DRUG Awaken by Quality Choice Foaming Hand Wash Spring Showers Benzalkonium Chloride SOAP TOPICAL 20160818 OTC MONOGRAPH NOT FINAL part333E Chain Drug MArketing Association Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63868-116_22a5d490-8468-4667-8568-4d095abbb7fc 63868-116 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) DOCUSATE SODIUM 100 mg/1 N 20181231 63868-117_18fbc066-d25f-4f83-8683-bd55409acb3c 63868-117 HUMAN OTC DRUG Quality Choice Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER Chain Drug Marketing Association PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 63868-119_56ba9a2d-0673-4917-aef8-5fd8c91a02ab 63868-119 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20150531 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 63868-120_769e017f-54c4-4db3-8831-18db972d5ecd 63868-120 HUMAN OTC DRUG Undecylenic Acid Antifungal Pen LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333C Chain Drug Marketing Association UNDECYLENIC ACID 25 mg/1.7mL N 20181231 63868-123_d97544db-beda-4dc0-9eec-83636ef2f14a 63868-123 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20141031 NDA NDA021920 QUALITY CHOICE (Chain Drug Marketing Association) NAPROXEN SODIUM 220 mg/1 N 20181231 63868-124_13c9c804-1a8e-461d-8e38-eae1dbd98eac 63868-124 HUMAN OTC DRUG Medicated Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part348 QUALITY CHOICE (Chain Drug Marketing Association) CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 6; 10 g/100g; g/100g; g/100g N 20181231 63868-125_458a43cc-97ea-4fa5-a251-500dc781b421 63868-125 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100714 OTC MONOGRAPH FINAL part332 QUALITY CHOICE (Chain Drug Marketing Association) DIMETHICONE 125 mg/1 N 20181231 63868-126_7a8d5b35-06f5-49f8-9e14-79ad8fc92da9 63868-126 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20140131 OTC MONOGRAPH FINAL part347 QUALITY CHOICE (Chain Drug Marketing Association) DIMETHICONE 125 mg/1 N 20181231 63868-128_9ca646c4-366a-4ace-a4d0-f36a31192c87 63868-128 HUMAN OTC DRUG Dye Free Allergy childrens Diphenhydramine Hydrochloride LIQUID ORAL 20160229 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 63868-129_af045d0b-c195-45b8-9b3d-abdb9709b027 63868-129 HUMAN OTC DRUG Dye Free Pain and Fever Childrens Acetaminophen SUSPENSION ORAL 20160229 OTC MONOGRAPH NOT FINAL part343 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN 160 mg/5mL N 20181231 63868-131_4672e211-0002-4741-be52-c287670ca9af 63868-131 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20101104 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 63868-132_47013191-5acd-464a-91b2-c2aee8b3d234 63868-132 HUMAN OTC DRUG Quality Choice Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Chain Drug Marketing Association Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 63868-133_7987339d-a8ac-439e-bd02-504e46ccbb72 63868-133 HUMAN OTC DRUG Quality Choice Childrens Allergy Relief Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Chain Drug Marketing Association CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 63868-135_686440fd-b9d2-4d1a-9a1d-ab73d8ce68a3 63868-135 HUMAN OTC DRUG Stool Softener Stimulant laxative docusate sodium and sennosides TABLET ORAL 20151130 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 63868-137_a26fd303-5f74-42d5-8590-bb9ede252799 63868-137 HUMAN OTC DRUG Stool Softener plus Laxative DOCUSATE SODIUM, SENNOSIDES TABLET ORAL 20151130 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 63868-138_b6006120-e76d-dcc4-5ea7-bbb39867f5fb 63868-138 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160815 ANDA ANDA208150 Chain Drug Marketing Association FLUTICASONE PROPIONATE 50 ug/1 N 20181231 63868-139_6924dcc3-9145-45dd-890c-f3b1aafab234 63868-139 HUMAN OTC DRUG All Day Allergy Cetirizine HCl CAPSULE ORAL 20160430 NDA NDA022429 QUALITY CHOICE (Chain Drug Marketing Association) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 63868-140_ccea4bab-3e3a-48ed-987a-98faa849e215 63868-140 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 63868-141_1d3b181b-776e-42c6-bb1b-2e039db266c3 63868-141 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET ORAL 20160331 ANDA ANDA079112 QUALITY CHOICE (Chain Drug Marketing Association) FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 63868-142_e998bf14-a9f5-4552-8c80-07dbf5c1ac72 63868-142 HUMAN OTC DRUG Flu HBP Maxium Strength Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr TABLET, FILM COATED ORAL 20050601 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 500; 2; 15 mg/1; mg/1; mg/1 N 20181231 63868-143_164c7698-4349-410d-8be1-a8e2a4837110 63868-143 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060428 ANDA ANDA077442 Chain Drug Marketing Association Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 63868-144_1e257438-1e45-4607-9b1d-0f0ee90e99db 63868-144 HUMAN OTC DRUG Nasal Decongestant PE Non-Drowsy Maximum Strength Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 63868-145_d93893bb-8d09-4bdd-928f-628b64e0bcd9 63868-145 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate and Dextromethorphan HBr TABLET, SUGAR COATED ORAL 20030503 20200505 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 63868-146_b359be70-3b20-492b-bfae-3f04b506bf99 63868-146 HUMAN OTC DRUG Suphedrine Maximum Strength Pseudoephedrine HCl TABLET, FILM COATED ORAL 19810825 20200222 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 63868-151_4d81a3ac-7d56-4d16-b0d6-32c1122004e3 63868-151 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Chain Drug Marketing Association Inc. LORATADINE 10 mg/1 N 20181231 63868-154_16bb532d-2a51-49d5-bea5-72bf47286ddb 63868-154 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Chain Drug Marketing Association Inc. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 63868-156_363c7fea-4d11-4c40-895e-1bcb1d2ffdad 63868-156 HUMAN OTC DRUG Quality Choice Childrens Allergy Relief Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Chain Drug Marketing Association LORATADINE 5 mg/5mL N 20181231 63868-157_f1415ccc-2075-46be-9778-002df4ea835d 63868-157 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Chain Drug Marketing Association Inc. LORATADINE 10 mg/1 N 20181231 63868-158_bbfd6735-9607-45e8-a4d8-845dc664f6c4 63868-158 HUMAN OTC DRUG Non-Aspirin Junior Strength Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN 160 mg/1 N 20181231 63868-160_08ef705a-2b53-4761-b851-0bce95d16505 63868-160 HUMAN OTC DRUG Travel Sickness Dimenhydrinate TABLET ORAL 20100714 OTC MONOGRAPH FINAL part336 QUALITY CHOICE (Chain Drug Marketing Association) DIMENHYDRINATE 50 mg/1 N 20181231 63868-163_0180a8ac-6353-46ae-8191-93b0bcc973a1 63868-163 HUMAN OTC DRUG Travel Ease Meclizine HCl TABLET, CHEWABLE ORAL 20020529 OTC MONOGRAPH FINAL part336 CHAIN DRUG MARKETING ASSOCIATION INC MECLIZINE HYDROCHLORIDE 25 mg/1 N 20191231 63868-164_edf9e143-c2cc-4877-a7b3-cda18aa6a7b9 63868-164 HUMAN OTC DRUG Quality Choice Quick Relief Diaper Rash Zinc Oxide CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 Chain Drug Marketing Association ZINC OXIDE 13 g/100g N 20181231 63868-165_5bec85c7-d69c-4ca7-a345-950cc030f41e 63868-165 HUMAN OTC DRUG Quality Choice Maximum Strength Diaper Rash Zinc Oxide CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 Chain Drug Marketing Association ZINC OXIDE 40 g/100g N 20181231 63868-167_a1ab3942-bbc0-4800-8642-d248d523d72d 63868-167 HUMAN OTC DRUG Nicotine Polacrilex Nicoitne Polacrilex GUM, CHEWING BUCCAL 20160701 ANDA ANDA078697 Chain Drug Marketing Association Inc. NICOTINE 4 mg/1 N 20181231 63868-168_a1ab3942-bbc0-4800-8642-d248d523d72d 63868-168 HUMAN OTC DRUG Nicotine Polacrilex Nicotine Polacrilex GUM, CHEWING BUCCAL 20160701 ANDA ANDA078699 Chain Drug Marketing Association Inc. NICOTINE 2 mg/1 N 20181231 63868-170_a958dac3-8156-4222-a379-82fb3c229a74 63868-170 HUMAN OTC DRUG QUALITY CHOICE OMEPRAZOLE omeprazole TABLET, DELAYED RELEASE ORAL 20140301 NDA NDA022032 Chain Drug Marketing Association OMEPRAZOLE 20 mg/1 N 20181231 63868-172_043ca44e-190a-4e36-bed1-02a6c0b0ae13 63868-172 HUMAN OTC DRUG Quality Choice Natural White Fluoride PASTE, DENTIFRICE DENTAL 20110120 OTC MONOGRAPH NOT FINAL part356 CHAIN DRUG MARKETING ASSOCIATION INC SODIUM FLUORIDE; POTASSIUM NITRATE .24; 5 g/100g; g/100g N 20181231 63868-174_b8416faf-94f1-425c-8100-0887268715d9 63868-174 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen SUSPENSION ORAL 20141031 OTC MONOGRAPH NOT FINAL part343 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN 160 mg/5mL N 20181231 63868-175_9b76dfd3-5c80-4a94-9127-d59a25894224 63868-175 HUMAN OTC DRUG Pain Relief Childrens Acetaminophen SUSPENSION ORAL 20151031 OTC MONOGRAPH NOT FINAL part343 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN 160 mg/5mL N 20181231 63868-176_ea3adbe9-f443-4f90-9324-226ab3a64129 63868-176 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen SUSPENSION ORAL 20150430 OTC MONOGRAPH NOT FINAL part343 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN 160 mg/5mL N 20181231 63868-177_427de6c7-d07b-3544-021a-080828b50f84 63868-177 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20160101 ANDA ANDA078878 Chain Drug Marketing Association OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 63868-179_d534713c-f2ac-428e-afae-8fd2d6744f46 63868-179 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine Maleate, Dextromethorphan HBr TABLET, COATED ORAL 20170331 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 63868-180_f6048172-de58-4304-9cc7-620740740501 63868-180 HUMAN OTC DRUG Miconazole Nitrate Athletes Foot Powder Spray Talc Free AEROSOL, POWDER TOPICAL 20171219 OTC MONOGRAPH FINAL part333C Chain Drug Marketing Association MICONAZOLE NITRATE 2.6 g/130g N 20181231 63868-181_d0064102-a769-4736-b4e4-9a0464fb2b78 63868-181 HUMAN OTC DRUG Tolnafate Tolnaftate Powder Spray AEROSOL, SPRAY TOPICAL 20171219 OTC MONOGRAPH FINAL part333C Chain Drug Marketing Association TOLNAFTATE 1.3 g/130g N 20181231 63868-186_23e81779-e1d6-4c7d-adcf-6084e852ec5a 63868-186 HUMAN OTC DRUG Non-Aspirin childrens acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN 160 mg/1 N 20181231 63868-187_7a6279ee-c8d1-4cff-8085-573923ef9b19 63868-187 HUMAN OTC DRUG Quality Choice Antibacterial Plus Urinary Pain Relief METHENAMINE, SODIUM SALICYLATE TABLET ORAL 20170222 UNAPPROVED DRUG OTHER Chain Drug Marketing Association METHENAMINE; SODIUM SALICYLATE 162; 162.5 mg/1; mg/1 N 20181231 63868-190_e38c24f2-0867-44f4-bb5e-b896af84ba7d 63868-190 HUMAN OTC DRUG Nicotine Transdermal System Step 1 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Chain Drug Marketing Association Inc. NICOTINE 21 mg/24h E 20171231 63868-191_e38c24f2-0867-44f4-bb5e-b896af84ba7d 63868-191 HUMAN OTC DRUG Nicotine Transdermal System Step 2 Nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 19991001 ANDA ANDA074612 Chain Drug Marketing Association Inc. NICOTINE 14 mg/24h E 20171231 63868-192_7aa781be-0a6e-48fc-ab4d-f64236728c99 63868-192 HUMAN OTC DRUG Nicotine Polacrilex, Coated Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 19991001 ANDA ANDA078699 Chain Drug Marketing Association Inc. NICOTINE 2 mg/1 N 20181231 63868-193_7aa781be-0a6e-48fc-ab4d-f64236728c99 63868-193 HUMAN OTC DRUG Nicotine Polacrilex, Coated Mint Flavor Nicotine Polacrilex GUM, CHEWING BUCCAL 19991001 ANDA ANDA078697 Chain Drug Marketing Association Inc. NICOTINE 4 mg/1 N 20181231 63868-197_8d8b54e5-1580-48a3-bb39-8e3e61a4e68f 63868-197 HUMAN OTC DRUG Quality Choice 3 Day Vaginal Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Chain Drug Marketing Association MICONAZOLE NITRATE 40 mg/g N 20181231 63868-198_348fe5e9-6b2b-4c8a-8651-ed091b6bb13e 63868-198 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20100701 ANDA ANDA074164 Chain Drug Marketing Association Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 63868-200_06a6bf23-3f40-4be0-a2c7-f531a00a2892 63868-200 HUMAN OTC DRUG Hydrocortisone Maximum Strength with aloe Hydrocortisone CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association Inc. HYDROCORTISONE 1 g/100g N 20181231 63868-201_602ee07d-771c-4328-e053-2991aa0ad96b 63868-201 HUMAN OTC DRUG Quality Choice Hemorrhoidal Mineral Oil OINTMENT RECTAL; TOPICAL 20130630 OTC MONOGRAPH FINAL part346 Chain Drug Marketing Association MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/100g; mg/100g; mg/100g N 20181231 63868-202_06a6bf23-3f40-4be0-a2c7-f531a00a2892 63868-202 HUMAN OTC DRUG Hydrocortisone Maximum Strength with aloe Hydrocortisone CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association Inc. HYDROCORTISONE 1 g/100g N 20181231 63868-205_18d8f61a-a03d-4a6a-9ca0-4447b8c39c94 63868-205 HUMAN OTC DRUG Therapeutic Plus Coal Tar SHAMPOO TOPICAL 20040526 OTC MONOGRAPH FINAL part358H C.D.M.A., INC COAL TAR 25 mg/mL N 20181231 63868-208_3f40247b-9c06-456c-87d0-d253163cd62a 63868-208 HUMAN OTC DRUG Hemorrhoidal COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20070926 OTC MONOGRAPH FINAL part346 Chain Drug Marketing Association, Inc. COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 1768.8; 5 mg/1; mg/1 E 20171231 63868-209_d26acc88-5087-46ad-962f-41ed0dcec888 63868-209 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET ORAL 20140831 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) BISACODYL 5 mg/1 N 20181231 63868-210_4b329b7c-7328-4d2a-84a2-2fb9972abf07 63868-210 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 63868-213_cce4f161-377f-42df-8e26-597ad27e647d 63868-213 HUMAN OTC DRUG Severe sinus Congestion Relief acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170713 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-217_771e0119-d019-44fe-9d3d-511b42d10384 63868-217 HUMAN OTC DRUG Regular Strength Pain Relief ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20170713 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association Inc. ACETAMINOPHEN 325 mg/1 N 20181231 63868-218_1d332d10-d249-4eb0-9b76-907a7f941214 63868-218 HUMAN OTC DRUG Anti itch Topical Analgesic Diphenhydramine Hydrochloride, Zinc Acetate CREAM TOPICAL 20140220 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Associations Inc DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 63868-219_15782dbb-26f8-45b8-a229-f574b0a9831a 63868-219 HUMAN OTC DRUG Nighttime Cold and Flu Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170713 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-220_a8ce4197-588c-4bb1-9e44-cd7df74a91ab 63868-220 HUMAN OTC DRUG COLD FLU and SORE THROAT RELIEF acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170713 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-222_eae21e09-77c5-49c5-af40-c07b299df70d 63868-222 HUMAN OTC DRUG Cough Relief DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20170713 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association Inc. DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 63868-227_df852117-4ed7-4f37-81c7-982fd4dfa09c 63868-227 HUMAN OTC DRUG Severe Sinus Congestion Allergy and Cough Formula Acetaminophen, Dextromethorphan hydrobromide , Doxylamine succinate, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170713 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-228_60f34e32-7459-6846-e053-2a91aa0a2ec2 63868-228 HUMAN OTC DRUG Quality Choice Effervescent Cold Relief Plus Aspirin, Chlorpheniramine maleate, and Phenylephrine bitartrate TABLET, EFFERVESCENT ORAL 20140101 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 N 20181231 63868-230_602c5fc2-0687-7ad9-e053-2a91aa0a282c 63868-230 HUMAN OTC DRUG Quality Choice Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Chain Drug Market Association POVIDONE-IODINE 100 mg/mL N 20181231 63868-234_786c50f7-77bf-493b-86e2-c9e4d72c9df8 63868-234 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20160831 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 63868-235_04cdac99-039e-43ba-a4b6-637f3eacc6da 63868-235 HUMAN OTC DRUG Mucus Relief DM Max Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 63868-236_fdfd88fb-fe1c-47af-9f48-588f4335fe95 63868-236 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20160331 OTC MONOGRAPH FINAL part347 QUALITY CHOICE (Chain Drug Marketing Association) DIMETHICONE 125 mg/1 N 20181231 63868-237_3d51c0cf-0f68-40d4-b27a-f5a160f50f46 63868-237 HUMAN OTC DRUG Cough Relief Nighttime Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 63868-239_04c0b978-4779-4f72-b548-6c95c21c1fdb 63868-239 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170823 ANDA ANDA206568 Chain Drug Marketing Association Inc. IBUPROFEN 200 mg/1 N 20181231 63868-240_06a92a2e-9b88-2a7c-e054-00144ff88e88 63868-240 HUMAN OTC DRUG Chewable Aspirin ASPIRIN TABLET, CHEWABLE ORAL 20140613 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ASPIRIN 81 mg/1 N 20181231 63868-241_351c42ba-1aed-4138-866e-7ddedc0eea00 63868-241 HUMAN OTC DRUG Dibromm Cold and Allergy Childrens Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/10mL; mg/10mL N 20181231 63868-242_a3fccfae-f1c8-4ab6-8fd4-d0b4fd52e87d 63868-242 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20171001 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) DOCUSATE SODIUM 100 mg/1 N 20181231 63868-244_4ae0262b-4c8c-4ef5-b9e4-1de5c19b747b 63868-244 HUMAN OTC DRUG Tussin CF Non Drowsy Dextromethorphan HBr, Guaifenesin, Phenylephrine LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 63868-246_e666f490-ee48-461c-8e7a-b21a1bcee26c 63868-246 HUMAN OTC DRUG Childrens Dibromm Cold and Allergy Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1; 2.5 mg/5mL; mg/5mL N 20181231 63868-247_8292bb0d-4d21-40ba-9b79-ddde7160b349 63868-247 HUMAN OTC DRUG Childrens Dibromm Cold and Cough Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 1; 2.5; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 63868-248_ed1f13f0-973e-402e-8638-9602d33f969e 63868-248 HUMAN OTC DRUG EZ Nite Sleep Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140731 OTC MONOGRAPH FINAL part338 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63868-249_91dcaea1-bb34-484b-9798-94dd4e0aa49b 63868-249 HUMAN OTC DRUG Awaken Oil-Free Daily Face Wash Salicylic Acid CREAM TOPICAL 20140901 OTC MONOGRAPH FINAL part333D Chain Drug Marketing Association SALICYLIC ACID 2 g/100mL N 20181231 63868-250_d09af2b3-62da-447d-bb7d-a68db1fa155a 63868-250 HUMAN OTC DRUG Awaken by Quality Choice Ultra Clean Daily Face Wash Salicylic Acid CREAM TOPICAL 20140901 OTC MONOGRAPH FINAL part333D Chain Drug Marketing Association SALICYLIC ACID 2 g/100g N 20181231 63868-251_e89a3265-1876-4dee-b69f-66dc13e4feeb 63868-251 HUMAN OTC DRUG Awaken by Quality Choice Anti-Wrinkle and Firming Moisturizer Day Broad Spectrum SPF18 Sunscreen Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Chain Drug Marketing Association AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g N 20181231 63868-252_1a776be8-78cc-4fd7-a969-99a0dae954a2 63868-252 HUMAN OTC DRUG Awaken Skin Perfector BB Broad Spectrum SPF 15 Sunscreen Light Medium Octinoxate and Titanium Dioxide CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Chain Drug Marketing Association OCTINOXATE; TITANIUM DIOXIDE 4; 2.1 g/100mL; g/100mL N 20181231 63868-253_991dba6e-f85c-445d-b0e5-c433cd15253a 63868-253 HUMAN OTC DRUG Awaken Skin Perfector BB Broad Spectrum SPF 15 Sunscreen Medium Dark Octinoxate and Titanium Dioxide CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Chain Drug Marketing Association OCTINOXATE; TITANIUM DIOXIDE 4; 2.1 g/100mL; g/100mL N 20181231 63868-254_9c7d780f-7c48-4795-867c-5104d4bdf0ed 63868-254 HUMAN OTC DRUG Awaken by Quality Choice Illuminating Daily Moisturizer Broad Spectrum SPF 15 Sunscreen Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Chain Drug Marketing Association AVOBENZONE; OCTISALATE; OCTOCRYLENE 3; 5; 8 g/100g; g/100g; g/100g N 20181231 63868-255_c3fd61cc-5645-4831-9917-55c24b161d70 63868-255 HUMAN OTC DRUG Awaken by Quality Choice Long-Lasting Oil-Free Moisturizer Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene and Oxybenzone CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Chain Drug Marketing Association AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 4; 3 g/100g; g/100g; g/100g; g/100g N 20181231 63868-256_455679dc-6624-40c3-9186-83e194e70c32 63868-256 HUMAN OTC DRUG Awaken by Quality Choice Absolute Daily Moisturizer Broad Spectrum SPF 15 Sunscreen Octinoxate and Zinc Oxide CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Chain Drug Marketing Association OCTINOXATE; ZINC OXIDE 6; 3 g/100g; g/100g N 20181231 63868-257_1f8d3ad0-3095-48f4-8acc-63982f84a075 63868-257 HUMAN OTC DRUG Natural Vegetable Laxative Sennosides TABLET, FILM COATED ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 CHAIN DRUG MARKETING ASSOCIATION INC SENNOSIDES 8.6 mg/1 N 20181231 63868-259_41aec9f8-f8a3-41c3-9e5e-d5301959640c 63868-259 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 20141015 ANDA ANDA074165 Chain Drug Marketing Association Inc. CLOTRIMAZOLE 10 mg/g N 20181231 63868-262_cd64a1c0-b097-4b7d-9b7a-e54b629254d9 63868-262 HUMAN OTC DRUG Stool Softener Plus Laxative Docusate sodium, Sennosides TABLET ORAL 20140831 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 63868-266_0c545df3-607f-4711-bd85-cfa1da21f1b4 63868-266 HUMAN OTC DRUG Chocolated Laxative Sennosides Stimulant Laxative TABLET, CHEWABLE ORAL 20140101 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association, Inc.) SENNOSIDES 15 mg/1 E 20171231 63868-267_be153570-f2c4-48d1-b987-33ad3ef630c7 63868-267 HUMAN OTC DRUG Vapor Inhaler Levmetamfetamine Nasal Decongestant INHALANT NASAL 20140101 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association, Inc. LEVMETAMFETAMINE 50 mg/1 E 20171231 63868-279_7d4e9ca3-e966-4a25-8987-460bea94853d 63868-279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part333A C.D.M.A. BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 63868-280_3bd7bacc-cf39-726f-e054-00144ff88e88 63868-280 HUMAN OTC DRUG Antiseptic Skin Cleanser Exidine-2 CHG CHLORHEXIDINE GLUCONATE SOLUTION TOPICAL 20160701 NDA NDA019422 Quality Choice CHLORHEXIDINE GLUCONATE 2 mg/100mL N 20181231 63868-281_b091cba3-d2a7-41a6-8a85-30d30ef8c9ca 63868-281 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170713 ANDA ANDA206568 Chain Drug Marketing Association Inc. IBUPROFEN 200 mg/1 N 20181231 63868-282_5e847254-a9b3-5cba-e053-2a91aa0a9bf0 63868-282 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20120320 OTC MONOGRAPH NOT FINAL part334 Chain Drug Marketing Association Inc. GLYCERIN 1.2 g/1 N 20181231 63868-283_5e83d3ef-91c7-1c3a-e053-2a91aa0a93ed 63868-283 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20120315 OTC MONOGRAPH NOT FINAL part334 Chain Drug Marketing Association Inc. GLYCERIN 2.1 g/1 N 20181231 63868-298_d6d7b4b9-c6c5-4622-8647-8818911bc8ba 63868-298 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20151001 OTC MONOGRAPH FINAL part358B Chain Drug Marketing Association Inc. SALICYLIC ACID .17 g/9.8mL N 20181231 63868-299_ec4e2c6c-2e59-4428-8b06-89de5658a0b3 63868-299 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20151001 OTC MONOGRAPH FINAL part358B Chain Drug Marketing Association Inc. SALICYLIC ACID .17 g/9mL N 20181231 63868-301_c1408135-fc45-405f-97e3-a1652c4ba4bc 63868-301 HUMAN OTC DRUG Childrens Triacting Nighttime Cold and Cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE 2.5; 6.25 mg/5mL; mg/5mL N 20181231 63868-303_a23ac67d-bb35-4778-8ac3-a52078368942 63868-303 HUMAN OTC DRUG QC Quality Choice Pink Bismuth Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20150323 OTC MONOGRAPH FINAL part335 Chain Drug Manufacturing Assn BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 63868-303_bbb7ddea-c8fd-4f81-b5b5-3b6038c5e572 63868-303 HUMAN OTC DRUG QC Quality Choice Pink Bismuth Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20150320 OTC MONOGRAPH FINAL part335 Chain Drug Manufacturing Assn BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 63868-308_c9351a5f-6cc8-4b47-9aa3-5e0cab0b67a0 63868-308 HUMAN OTC DRUG 2-Count HEAT PATCHES CAPSAICIN PATCH TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 QUALITY CHOICE (Chain Drug Marketing Association) CAPSAICIN .025 g/100g N 20181231 63868-309_e7018d4f-21fd-4d90-a771-d088fd976f7e 63868-309 HUMAN OTC DRUG QUALITY CHOICE PAIN RELIEF PATCHES LIDOCAINE PATCH TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part348 QUALITY CHOICE (Chain Drug Marketing Association) LIDOCAINE 4 g/100g N 20181231 63868-310_45419ab8-43f3-4ffb-8583-fece4271cd82 63868-310 HUMAN OTC DRUG MILK OF MAGNESIA CHERRY magnesium hydroxide LIQUID ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 Chain Drug Marketing Association MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 63868-317_602bd9cf-b2e9-5d57-e053-2a91aa0a2b43 63868-317 HUMAN OTC DRUG Quality Choice Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Chain Drug Market Association ZINC OXIDE 160 mg/mL N 20181231 63868-322_602bc460-6bd5-bd64-e053-2991aa0aa8e9 63868-322 HUMAN OTC DRUG Quality Choice Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 Chain Drug Market Asociation CASTOR OIL 1 mg/mL N 20181231 63868-325_066f3051-06cf-62ea-e054-00144ff8d46c 63868-325 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20071108 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 63868-326_699de549-9331-452d-895e-534c031c1d0d 63868-326 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20130826 OTC MONOGRAPH NOT FINAL part356 C.D.M.A., Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63868-328_545418af-ffb3-4c46-9548-c4ecf71b1b7d 63868-328 HUMAN OTC DRUG Laxative BISACODYL SUPPOSITORY RECTAL 20071221 OTC MONOGRAPH NOT FINAL part334 Chain Drug Marketing Association, Inc. BISACODYL 10 mg/1 E 20171231 63868-330_602c4ad6-79cd-5237-e053-2a91aa0acb1d 63868-330 HUMAN OTC DRUG Quality Choice Iodine Tincture Mild Iodine and Sodium Iodide and Alcohol LIQUID TOPICAL 19790101 OTC MONOGRAPH NOT FINAL part333A Chain Drug Market Association IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 63868-331_602b53df-c980-3071-e053-2991aa0a56cc 63868-331 HUMAN OTC DRUG Quality Choice Iodides Tincture Ethyl Alcohol LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Chain Drug Market Association ALCOHOL .45 mL/mL N 20181231 63868-338_c91f9b96-ee50-410f-87de-ee30135422ac 63868-338 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Chain Drug Marketing Association Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 63868-352_99b78f54-2465-4172-ac6a-76343992af14 63868-352 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ASPIRIN 325 mg/1 N 20181231 63868-354_2c923a8f-6b4d-49f7-84fa-f06a44fbf068 63868-354 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 QUALITY CHOICE (Chain Drug Marketing Association) ASPIRIN 81 mg/1 N 20181231 63868-356_e496d23e-d1ea-412e-805a-778b4f12bcc6 63868-356 HUMAN OTC DRUG Quality Choice Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20150115 OTC MONOGRAPH FINAL part333B Chain Drug Marketing Association Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 63868-360_73cabdc7-cdd5-4392-86a4-f1ea5824ce84 63868-360 HUMAN OTC DRUG Quality Choice Gentle Laxative Bisacodyl SUPPOSITORY RECTAL 20150213 OTC MONOGRAPH NOT FINAL part334 Chain Drug Marketing Association BISACODYL 10 mg/2000mg N 20181231 63868-363_2d6627ad-7aa0-4939-9be0-91b2861a10da 63868-363 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ASPIRIN 81 mg/1 N 20181231 63868-364_f7c65393-e192-47eb-8272-9ab447c41ee1 63868-364 HUMAN OTC DRUG Athletes Foot Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Chain Drug Marketing Association, Inc. TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 63868-368_eee55dd2-e314-4056-97c4-5768530e8b03 63868-368 HUMAN OTC DRUG Childrens Triacting Nighttime Cold and Cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20140530 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE 2.5; 6.25 mg/5mL; mg/5mL N 20181231 63868-369_8e60973f-a7d9-439d-acfc-b271493e702e 63868-369 HUMAN OTC DRUG Triacting Daytime Cold Cough Childrens Dextromethorphan HBr, Phenylephrine HCl SYRUP ORAL 20140530 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 5; 2.5 mg/5mL; mg/5mL N 20181231 63868-370_0cfd954c-7c98-4f1e-b797-38c8c497d320 63868-370 HUMAN OTC DRUG Childrens Allergy Diphenhydramine Hydrochloride LIQUID ORAL 20140530 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 63868-373_06ba7619-b3d3-70a4-e054-00144ff88e88 63868-373 HUMAN OTC DRUG Aspirin 81 mg ASPIRIN TABLET, DELAYED RELEASE ORAL 20140613 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ASPIRIN 81 mg/1 N 20181231 63868-374_45639a30-45b6-4c40-8587-cad5d83dd462 63868-374 HUMAN OTC DRUG Childrens Multi-Symptom Cold Plus Dye-Free Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride SUSPENSION ORAL 20150531 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 63868-380_06c85bb1-ded1-4dac-bc63-d37981a3efc8 63868-380 HUMAN OTC DRUG QUALITY CHOICE SINGLE SALINE LAXATIVE SODIUM PHOSPHATE, DIBASIC and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM ENEMA RECTAL 20100601 OTC MONOGRAPH NOT FINAL part334 CDMA SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 7; 19 g/118mL; g/118mL N 20181231 63868-384_54d2911a-4f2b-4047-b9be-700db19f2ad6 63868-384 HUMAN OTC DRUG Quality Choice Nighttime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20121129 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 63868-386_1162a5ed-136d-4a32-b090-c647d0e079a8 63868-386 HUMAN OTC DRUG Quality Choice Multi-Symptom, Non-Drowsy DayTime Cold and Flu ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20121108 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 63868-389_a1741ca0-6058-47e2-b60c-756ab935521e 63868-389 HUMAN OTC DRUG Mucus Guaifenesin TABLET, EXTENDED RELEASE ORAL 20171115 NDA NDA021282 CHAIN DRUG MARKETING ASSOCIATION INC GUAIFENESIN 600 mg/1 N 20181231 63868-390_c230aa72-6b07-4659-9cba-395ec1574a71 63868-390 HUMAN OTC DRUG Guaifenesin Extended Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20171015 NDA NDA021282 CHAIN DRUG MARKETING ASSOCIATION INC GUAIFENESIN 1200 mg/1 N 20181231 63868-391_0e0be98e-adad-4427-aac5-7d37736f0cdd 63868-391 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20171210 NDA NDA021620 CHAIN DRUG MARKETING ASSOCIATION INC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 63868-400_6fe336de-8d74-63ab-9199-ee2eb7619c41 63868-400 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20171213 ANDA ANDA208150 Chain Drug Marketing Association FLUTICASONE PROPIONATE 50 ug/1 N 20181231 63868-406_f6636fa7-c50c-4c2b-bc4c-da7f21836a1c 63868-406 HUMAN OTC DRUG Quality Choice Cold Sore Treatment Benzalkonium Chloride CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part333A Chain Drug Marketing Association Inc BENZALKONIUM CHLORIDE 1.3 mg/g N 20181231 63868-420_5e08cd6d-95d9-2ad2-e053-2a91aa0a62ff 63868-420 HUMAN OTC DRUG Quality Choice Anti-itch Medicated Calamine and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 CHAIN DRUG MARKETING ASSOCIATION INC ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 63868-430_128c61e2-ecd5-4f55-b12d-3c95b1c8ddab 63868-430 HUMAN OTC DRUG Childrens Allergy Cetirizine HCl LIQUID ORAL 20141231 ANDA ANDA090474 QUALITY CHOICE (Chain Drug Marketing Association) CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 63868-453_9b971e5f-98b5-4030-96d0-2b8aa5c03609 63868-453 HUMAN OTC DRUG Ibuprofen and Pseudoephedrine Hydrochloride Ibuprofen and Pseudoephedrine Hydrochloride TABLET, SUGAR COATED ORAL 20011013 ANDA ANDA074567 Chain Drug Marketing Association Inc. IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 N 20181231 63868-460_e6f691ad-2f2f-448c-b856-df5bd12b42a3 63868-460 HUMAN OTC DRUG NightTime Maximum Strength Cold and Flu Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate, Dextromethorphan hydrobromide CAPSULE, LIQUID FILLED ORAL 20160803 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-461_8ad04440-3b05-42f9-a810-737bc405b6cb 63868-461 HUMAN OTC DRUG DayTime Maximum Strength Cold and Flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20160803 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-463_3270ba0a-5e3c-4b74-8042-5aed7bdf06e5 63868-463 HUMAN OTC DRUG DayTime Sinus acetaminophen, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170412 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 63868-464_70e1b7f5-0912-48d0-a6f9-4a7d42d86d4c 63868-464 HUMAN OTC DRUG Daytime Sinus Relief and Nighttime Sinus Relief acetaminophen, doxylamine succinate, phenylephrine hydrochloride KIT 20170412 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association Inc. N 20181231 63868-465_06ba032d-b5af-115f-e054-00144ff88e88 63868-465 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20090903 ANDA ANDA079096 Chain Drug Marketing Association NAPROXEN SODIUM 220 mg/1 N 20181231 63868-466_06ba032d-b5c4-115f-e054-00144ff88e88 63868-466 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20090619 ANDA ANDA079096 Chain Drug Marketing Association NAPROXEN SODIUM 220 mg/1 N 20181231 63868-476_4cd7193b-be70-4a32-82f0-249793f231eb 63868-476 HUMAN OTC DRUG Awaken by Quality Choice Hand Sanitizer Vanilla Crm and Apple Blossom Ethyl Alcohol LIQUID TOPICAL 20160818 OTC MONOGRAPH NOT FINAL part333E Chain Drug Marketing Association Inc ALCOHOL 650 mg/mL N 20181231 63868-481_dd065d30-d565-4b51-a263-78f189ff9c0e 63868-481 HUMAN OTC DRUG Awaken by Quality Choice Hand Sanitizer Citrus Coconut Ethyl Alcohol LIQUID TOPICAL 20160818 OTC MONOGRAPH NOT FINAL part333E Chain Drug Marketing Association Inc ALCOHOL 650 mg/mL N 20181231 63868-485_38efe66f-ed4c-4a9b-925d-a58d2943b6c8 63868-485 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 63868-486_20a81e6f-a829-46d0-a486-136302b0ef61 63868-486 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100723 ANDA ANDA090283 Chain Drug Marketing Association Inc. FAMOTIDINE 20 mg/1 N 20181231 63868-487_101b4abe-d563-46bd-b6af-2c16116d3ed3 63868-487 HUMAN OTC DRUG ACID REDUCER Ranitidine TABLET ORAL 20120330 ANDA ANDA200536 Chain Drug Marketing Association Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 63868-489_602b6056-c96e-4abf-e053-2991aa0ada6f 63868-489 HUMAN OTC DRUG Quality Choice Aromatic Ammonia Spirit Ammonia 2% LIQUID TOPICAL 20080101 UNAPPROVED DRUG OTHER Chain Drug Market Association AMMONIA 20 mg/mL N 20181231 63868-490_602b4f44-4f93-3073-e053-2991aa0a28a0 63868-490 HUMAN OTC DRUG Quality Choice Camphor Spirit Camphor 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part348 Chain Drug Market Association CAMPHOR (NATURAL) 100 mg/mL N 20181231 63868-492_06a925de-0832-2754-e054-00144ff88e88 63868-492 HUMAN OTC DRUG Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20140613 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63868-493_602c50fc-777d-745e-e053-2a91aa0afa39 63868-493 HUMAN OTC DRUG Quality Choice Merthiolate Benzalkonium Chloride LIQUID TOPICAL 19980325 OTC MONOGRAPH NOT FINAL part333A Chain Drug Market Association BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63868-503_066f3051-06e3-62ea-e054-00144ff8d46c 63868-503 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20070315 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 500 mg/1 N 20181231 63868-507_066f3051-06bc-62ea-e054-00144ff8d46c 63868-507 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET, COATED ORAL 20070814 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 500 mg/1 N 20181231 63868-549_56d0c4c5-c712-4ae9-955a-33697a4d93b3 63868-549 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET ORAL 20100331 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) SENNOSIDES 25 mg/1 N 20181231 63868-553_8e0c8f4e-b872-4c2b-b4d4-b3700b55fba5 63868-553 HUMAN OTC DRUG QUALITY CHOICE MINT CETYLPRYIDINIUM CHLORIDE LIQUID ORAL 20150913 OTC MONOGRAPH NOT FINAL part356 CHAIN DRUG MARKETING ASSOCIATION INC CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 63868-556_916658c6-98a5-4f65-9504-2d4c9eaca886 63868-556 HUMAN OTC DRUG QUALITY CHOICE AMBER EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20150913 OTC MONOGRAPH NOT FINAL part356 CHAIN DRUG MARKETING ASSOCIATION INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63868-557_a166be5c-379b-4a0c-8a04-42b19b9e825e 63868-557 HUMAN OTC DRUG QUALITY CHOICE BLUE MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20150913 OTC MONOGRAPH NOT FINAL part356 CHAIN DRUG MARKETING ASSOCIATION INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63868-558_de6dabfd-0aa5-4bf6-88ca-52fddf7637de 63868-558 HUMAN OTC DRUG QUALITY CHOICE SPRNG MINT EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL LIQUID ORAL 20150913 OTC MONOGRAPH NOT FINAL part356 CHAIN DRUG MARKETING ASSOCIATION INC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63868-560_efa96387-f82d-4584-ba59-aa14fb7c4b5d 63868-560 HUMAN OTC DRUG Stool Softener Laxative DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170831 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) DOCUSATE SODIUM 100 mg/1 N 20181231 63868-593_1b8dd779-4795-49de-b2a1-b7c4241f7a04 63868-593 HUMAN OTC DRUG Quality Choice Maximum Strength Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20150120 OTC MONOGRAPH FINAL part347 Chain Drug Marketing Association Inc ZINC OXIDE 40 g/100g N 20181231 63868-594_6ccfd602-3d65-4588-a891-3db781d03b5e 63868-594 HUMAN OTC DRUG Quality Choice Maximum Strength Anti Itch Hydrocortisone CREAM TOPICAL 20150119 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association Inc HYDROCORTISONE 1 g/100g N 20181231 63868-595_e37bb13b-5a8a-432c-ae28-ab7ff0b46e26 63868-595 HUMAN OTC DRUG Quality Choice Clotrimazole Clotrimazole CREAM TOPICAL 20150119 OTC MONOGRAPH FINAL part333C Chain Drug Marketing Association CLOTRIMAZOLE 10 mg/g N 20181231 63868-596_89435f5b-ee27-40bf-8f9c-889821a5299f 63868-596 HUMAN OTC DRUG Quality Choice Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association Inc HYDROCORTISONE 1 g/100g N 20181231 63868-597_ce0c97fe-29c8-46db-8ebe-7e7051c401c8 63868-597 HUMAN OTC DRUG Quality Choice Anti Itch with Aloe Hydrocortisone OINTMENT TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association Inc HYDROCORTISONE 1 g/100g N 20181231 63868-611_066f1786-03e9-02cc-e054-00144ff8d46c 63868-611 HUMAN OTC DRUG Nighttime Sleep Aid DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20070625 OTC MONOGRAPH FINAL part338 Chain Drug Marketing Association DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63868-612_919ab53b-c38d-4d83-84e5-996aa4ce5a86 63868-612 HUMAN OTC DRUG Sleep aid Maximum Strength DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 63868-632_6cc12487-23a4-4366-8880-6f648f8042f2 63868-632 HUMAN OTC DRUG Icy Cool Maximum Strength Menthol GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 C.D.M.A. Inc. MENTHOL 55 mg/mL E 20171231 63868-633_0e6e835a-a87d-4a1b-b3c8-b3319b4f9473 63868-633 HUMAN OTC DRUG Icy Cool Maximum Strength Menthol GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 C.D.M.A. Inc. MENTHOL 55 mg/mL E 20171231 63868-634_60a5b67e-b866-4772-e053-2991aa0af22a 63868-634 HUMAN OTC DRUG QC Ultra Lubricant Eye Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20160930 OTC MONOGRAPH FINAL part349 Chain Drug Marketing Association Inc POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 63868-658_f5706479-1ded-43c2-950a-21fbecd71ae0 63868-658 HUMAN OTC DRUG Allergy Relief Dye-Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63868-664_44f0f6eb-333b-441e-9ce6-44aac4c1ef69 63868-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19950111 OTC MONOGRAPH NOT FINAL part356 C.D.M.A., Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63868-687_5bcf91a9-9644-488a-a191-0071e0fbe0b3 63868-687 HUMAN OTC DRUG Therapeutic T Plus Coal Tar SHAMPOO TOPICAL 20130530 OTC MONOGRAPH FINAL part358H Chain Drug Marketing Association COAL TAR 25 mg/mL N 20181231 63868-694_b47b2424-925a-4016-80ee-8d510d6c29c5 63868-694 HUMAN OTC DRUG ANTACID MINT aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20140301 OTC MONOGRAPH FINAL part331 Chain Drug Marketing Association ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 63868-711_1300e024-05f2-4280-aa5f-fbbd17b3b0b8 63868-711 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Chain Drug Marketing Association Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 63868-712_3f5dcd28-e57f-40d6-b4a8-98399a6dd339 63868-712 HUMAN OTC DRUG REGULAR STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20140301 OTC MONOGRAPH FINAL part331 Chain Drug Marketing Association ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 63868-714_20a81e6f-a829-46d0-a486-136302b0ef61 63868-714 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100625 ANDA ANDA090283 Chain Drug Marketing Association Inc. FAMOTIDINE 10 mg/1 N 20181231 63868-715_60ddf159-18dd-6b1a-e053-2991aa0a8d16 63868-715 HUMAN OTC DRUG MAXIMUM STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20140301 OTC MONOGRAPH FINAL part331 Chain Drug Marketing Association ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 63868-716_06ba7913-286e-1723-e054-00144ff8d46c 63868-716 HUMAN OTC DRUG Mucus Relief Severe Cold ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130924 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-717_06ba7913-2858-1723-e054-00144ff8d46c 63868-717 HUMAN OTC DRUG Mucus Relief Cold and Sinus ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130924 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 63868-719_06ba7a68-6181-25ea-e054-00144ff88e88 63868-719 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20130924 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-720_06ac9e02-95d8-3046-e054-00144ff88e88 63868-720 HUMAN OTC DRUG Pressure Pain Cough PE ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20140521 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 63868-721_06ac9e02-9601-3046-e054-00144ff88e88 63868-721 HUMAN OTC DRUG Pressure Pain Cold PE ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20140521 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 100; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63868-722_18a7a992-81eb-6aa0-e054-00144ff8d46c 63868-722 HUMAN OTC DRUG Mucus Relief Sinus Severe Congestion Relief ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20150610 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 63868-723_18a7b859-570e-6dd5-e054-00144ff88e88 63868-723 HUMAN OTC DRUG Mucus Relief Sinus Pressure and Pain ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20150610 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 63868-741_321a56ce-8250-45b0-a331-2eca8c11215c 63868-741 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20100304 ANDA ANDA074916 Chain Drug Marketing Association Inc. IBUPROFEN 100 mg/5mL N 20181231 63868-743_ff9fb48d-3fbb-437d-af08-eb61b98bc439 63868-743 HUMAN OTC DRUG Mucus Relief Cold and Sinus Maximum Strength Acetaminophen, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 63868-745_65ae4fa3-2590-4b0b-9665-aa1322c158f8 63868-745 HUMAN OTC DRUG Mucus Relief Severe Congestion and Cough Maximum Strength dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride LIQUID ORAL 20150131 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 63868-746_ef90f299-77d2-4709-9b24-2069954dbd15 63868-746 HUMAN OTC DRUG Mucus Relief Cold Flu and Sore Throat Maximum Strength Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20150131 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 63868-747_06ac9e02-95ed-3046-e054-00144ff88e88 63868-747 HUMAN OTC DRUG Pressure Pain Mucus PE ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20140521 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 63868-748_8d63ddc9-2c17-4b33-9a66-756924fc3888 63868-748 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20130531 NDA NDA021855 QUALITY CHOICE (Chain Drug Marketing Association) LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 63868-752_a3f885ab-8205-4c5d-8eac-ec6897cdd41a 63868-752 HUMAN OTC DRUG Quality Choice Mucus Relief PE PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 63868-753_438caead-b30f-40c0-bc9a-e5c661a48df8 63868-753 HUMAN OTC DRUG Quality Choice Mucus Relief DM DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 63868-756_321a56ce-8250-45b0-a331-2eca8c11215c 63868-756 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20061009 ANDA ANDA074916 Chain Drug Marketing Association Inc. IBUPROFEN 100 mg/5mL N 20181231 63868-758_321a56ce-8250-45b0-a331-2eca8c11215c 63868-758 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080110 ANDA ANDA074916 Chain Drug Marketing Association Inc. IBUPROFEN 100 mg/5mL N 20181231 63868-759_2ef1827a-300c-4944-8fb0-fd820f2bafd3 63868-759 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130311 ANDA ANDA078682 QUALITY CHOICE (Chain Drug Marketing Association) IBUPROFEN 200 mg/1 N 20181231 63868-763_28b21bb0-32b1-0954-e054-00144ff8d46c 63868-763 HUMAN OTC DRUG Quality Choice Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20131118 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 63868-764_28c1544e-adc6-55b7-e054-00144ff8d46c 63868-764 HUMAN OTC DRUG Quality Choice Nighttime Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea Flavors Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20131202 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 63868-765_28c4fcc2-0a53-1752-e054-00144ff8d46c 63868-765 HUMAN OTC DRUG Quality Choice Cold and Sore Throat Lemon Flavor Acetaminophen, Pheniramine Maleate, Phenylephrine HCl GRANULE, FOR SOLUTION ORAL 20130725 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 20; 10 mg/1; mg/1; mg/1 N 20181231 63868-770_72bb9e79-59fc-4b24-b319-d25914fa2cbc 63868-770 HUMAN OTC DRUG Childrens Mucus Relief Chest Congestion Guaifenesin SOLUTION ORAL 20151019 OTC MONOGRAPH FINAL part341 Chain Drug Manufacturing Assn GUAIFENESIN 100 mg/5mL N 20181231 63868-771_f272617b-09f2-4e92-b4ca-70016651856d 63868-771 HUMAN OTC DRUG Childrens Mucus and Cough Relief GUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20151019 OTC MONOGRAPH FINAL part341 Chain Drug Manufacturing Assn DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 63868-772_06a826d2-da21-2dd8-e054-00144ff8d46c 63868-772 HUMAN OTC DRUG Rest Simply DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED ORAL 20140613 OTC MONOGRAPH FINAL part338 Chain Drug Marketing Association DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63868-773_f541a05a-b3ba-4123-8524-ae67b7fcf1ff 63868-773 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 CHAIN DRUG MARKETING ASSOCIATION INC IBUPROFEN 200 mg/1 N 20181231 63868-774_321a56ce-8250-45b0-a331-2eca8c11215c 63868-774 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20141010 ANDA ANDA074916 Chain Drug Marketing Association Inc. IBUPROFEN 100 mg/5mL N 20181231 63868-775_5ae27f23-e651-41b7-b4e8-84ccabfbc1c0 63868-775 HUMAN OTC DRUG Cold and Cough Childrens Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 63868-777_ba131043-833e-4c9d-82b8-767efe8517e3 63868-777 HUMAN OTC DRUG Acne Cleanser Awaken by Quality Choice Salicylic Acid 2.00% LIQUID TOPICAL 20141113 OTC MONOGRAPH FINAL part333D Quality Choice SALICYLIC ACID 2 g/100mL N 20191231 63868-787_b84dbe16-0d51-4001-8167-b089cb7dcfa3 63868-787 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 Chain Drug Marketing Association MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 63868-788_367011e8-52f8-4043-a7e4-6fa5957562f8 63868-788 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20140401 OTC MONOGRAPH NOT FINAL part334 Chain Drug Marketing Association MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 63868-790_06a92a2e-9b9c-2a7c-e054-00144ff88e88 63868-790 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20070511 ANDA ANDA091355 Chain Drug Marketing Association IBUPROFEN 200 mg/1 N 20181231 63868-791_06a92a2e-9bb0-2a7c-e054-00144ff88e88 63868-791 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20070511 ANDA ANDA091355 Chain Drug Marketing Association IBUPROFEN 200 mg/1 N 20181231 63868-792_06ac99ec-0f30-61ed-e054-00144ff8d46c 63868-792 HUMAN OTC DRUG Severe Allergy Relief Plus Sinus Headache ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20120222 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 25; 5 mg/1; mg/1; mg/1 N 20181231 63868-793_06a92a2e-9bdc-2a7c-e054-00144ff88e88 63868-793 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20140514 ANDA ANDA091355 Chain Drug Marketing Association IBUPROFEN 200 mg/1 N 20181231 63868-794_06a92a2e-9bc8-2a7c-e054-00144ff88e88 63868-794 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20140514 ANDA ANDA091355 Chain Drug Marketing Association IBUPROFEN 200 mg/1 N 20181231 63868-802_b86a54a9-9e23-481d-a5dd-d4976c13e0fc 63868-802 HUMAN OTC DRUG Nasal Decongestant Maximum Strength Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 63868-807_06627e0c-1aed-46ac-9cf5-72ba30587473 63868-807 HUMAN OTC DRUG Night Time Cough Cherry Vicks NyQuil LIQUID ORAL 20131028 20181231 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 63868-807_aa10cd2a-fb73-4b88-8c40-eeeeb8b3c527 63868-807 HUMAN OTC DRUG Night Time Cough Cherry Vicks NyQuil LIQUID ORAL 20131028 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 63868-808_4033f885-93f0-444e-995e-fe00bbb28ae3 63868-808 HUMAN OTC DRUG Cough Relief Nighttime Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20160229 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 63868-811_26dea46a-b3bf-4a52-841f-fad7c9673a11 63868-811 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140831 OTC MONOGRAPH NOT FINAL part356 QUALITY CHOICE (Chain Drug Marketing Association) PHENOL 1.4 g/100mL N 20181231 63868-812_1b775992-1553-4ac4-8dcb-1a905e1127f7 63868-812 HUMAN OTC DRUG Sore Throat Menthol Phenol LIQUID ORAL 20140831 OTC MONOGRAPH NOT FINAL part356 QUALITY CHOICE (Chain Drug Marketing Association) PHENOL 1.4 g/100mL N 20181231 63868-823_9e4c2bcb-3a7e-4f47-b55f-ef386047a306 63868-823 HUMAN OTC DRUG Childrens Allergy Diphenhydramine HCl LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 63868-833_06a826d2-da11-2dd8-e054-00144ff8d46c 63868-833 HUMAN OTC DRUG Allergy Relief CHLORPHENIRAMINE MALEATE TABLET, COATED ORAL 20141001 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 63868-834_29248e4b-0958-424a-b9a0-becb08f89c82 63868-834 HUMAN OTC DRUG Pain Relief Infants Acetaminophen SUSPENSION ORAL 20151130 OTC MONOGRAPH NOT FINAL part343 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN 160 mg/5mL N 20181231 63868-835_f396f154-eff8-4c3a-96ed-d48d91fddb5a 63868-835 HUMAN OTC DRUG Pain Relief Infants Dye Free Acetaminophen SUSPENSION ORAL 20151130 OTC MONOGRAPH NOT FINAL part343 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN 160 mg/5mL N 20181231 63868-836_a5244483-f5dd-4886-b5b6-142474d9a58c 63868-836 HUMAN OTC DRUG Pain Relief Infants Acetaminophen SUSPENSION ORAL 20150531 OTC MONOGRAPH NOT FINAL part343 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN 160 mg/5mL N 20181231 63868-846_feacbbec-72ab-4ec3-a28f-444106e88906 63868-846 HUMAN OTC DRUG Tussin DM Sugar Free Non Drowsy Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 63868-855_a42493b6-41a5-4c4c-943d-83ed4b855ec6 63868-855 HUMAN OTC DRUG Tussin DM Sugar Free Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140530 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 63868-857_ff80b731-3a00-4e6b-9296-f41a1b13f340 63868-857 HUMAN OTC DRUG Tussin Non Drowsy Guaifenesin LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) GUAIFENESIN 100 mg/5mL N 20181231 63868-859_7d09d2cb-b075-4f62-9039-347fce6dab31 63868-859 HUMAN OTC DRUG Tussin Mucus and Chest Congestion Adult Guaifenesin LIQUID ORAL 20150531 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) GUAIFENESIN 200 mg/10mL N 20181231 63868-863_0d7915f9-6ef6-4aaf-a24c-d1fa56ddacad 63868-863 HUMAN OTC DRUG Extra Strength Pain Relief ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20160722 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association Inc. ACETAMINOPHEN 500 mg/1 N 20181231 63868-864_b2d78b62-beab-4fbe-9c6d-c00b3a23e507 63868-864 HUMAN OTC DRUG DayTime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20170308 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 63868-865_b4feed95-86ca-411c-99b5-773e485e752f 63868-865 HUMAN OTC DRUG CHILDRENS ALLERGY RELIEF Cetirizine Hydrochloride SOLUTION ORAL 20141120 ANDA ANDA090750 C.D.M.A., Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 63868-866_a4745259-99b8-4466-a9d9-ea18a1397c40 63868-866 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20140910 OTC MONOGRAPH NOT FINAL part343 C.D.M.A., Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 63868-867_3b79ac79-3700-48dc-a547-338780195b9a 63868-867 HUMAN OTC DRUG Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20140910 OTC MONOGRAPH FINAL part341 C.D.M.A., Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 63868-868_d4d184d7-13b9-4f8d-9162-c3aad8136346 63868-868 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion Non Drowsy Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140930 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 63868-898_54421c3d-5b0a-4cf7-8108-dab8b170a993 63868-898 HUMAN OTC DRUG Enteric Aspirin Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ASPIRIN 325 mg/1 N 20181231 63868-903_113f8438-b42f-4e8a-8e6d-17b2ebe60a52 63868-903 HUMAN OTC DRUG QUALITY CHOICE ORIGINAL EYE DROPS TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION OPHTHALMIC 20120930 OTC MONOGRAPH FINAL part349 CHAIN DRUG MARKETING ASSOCIATION INC TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 63868-910_d52658cd-5cb6-4a90-a051-3684d480ea75 63868-910 HUMAN OTC DRUG Quality Choice Maximum Strength Triple Antibiotic Bacitracin Zinc, Neomycin, Polymyxin B Sulfate, Pramoxine Hydrochloride OINTMENT TOPICAL 20140325 OTC MONOGRAPH FINAL part333B Chain Drug Marketing Association Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 63868-925_d952540f-70bc-49fd-b432-c8c3ba536cb6 63868-925 HUMAN OTC DRUG Isopropyl alcohol 70 percent Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A QUALITY CHOICE (Chain Drug Marketing Association) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 63868-926_ffde33be-0e4a-418a-9d38-2427e0390967 63868-926 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part356 QUALITY CHOICE (Chain Drug Marketing Association) HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 63868-927_8000d603-d56d-4bff-8c4d-6bc3028d8f77 63868-927 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140731 OTC MONOGRAPH FINAL part347 QUALITY CHOICE (Chain Drug Marketing Association) WITCH HAZEL 842 mg/mL N 20181231 63868-933_2f5e74de-7312-4404-9933-9f6cf24f1954 63868-933 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333A QUALITY CHOICE (Chain Drug Marketing Association) ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 63868-934_2d403a28-3167-4e64-8c70-5b569f86aa94 63868-934 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20140630 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 63868-935_f12fae7c-2df4-4fb1-ba47-6e6df32e3673 63868-935 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20140630 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 63868-936_35f37eef-981a-4b69-93b1-bd85354c7d3c 63868-936 HUMAN OTC DRUG Isopropyl alcohol 70 percent Wintergreen Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A QUALITY CHOICE (Chain Drug Marketing Association) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 63868-938_71280084-3700-4a94-8bbb-d97a419803a4 63868-938 HUMAN OTC DRUG Mineral oil Mineral oil OIL ORAL 20140731 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) MINERAL OIL 100 mg/100mL N 20181231 63868-939_4ad061f7-cd8e-497f-8798-87ef4abbbfd1 63868-939 HUMAN OTC DRUG Isopropyl alcohol 50 percent Isopropyl alcohol LIQUID TOPICAL 20140630 OTC MONOGRAPH NOT FINAL part333A QUALITY CHOICE (Chain Drug Marketing Association) ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 63868-940_25389ff1-1207-5f4a-e054-00144ff8d46c 63868-940 HUMAN OTC DRUG Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% LIQUID TOPICAL 20140501 NDA NDA019125 Chain Drug Marketing Association Inc. CHLORHEXIDINE GLUCONATE 4 mg/100mL N 20181231 63868-942_73de213a-11b6-4952-8dc7-397254cd4dd6 63868-942 HUMAN OTC DRUG Magnesium Citrate Saline Laxative Magnesium citrate LIQUID ORAL 20160831 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 63868-943_11a80326-1bac-40ae-a071-99bd475e8785 63868-943 HUMAN OTC DRUG Magnesium Citrate saline laxative Magnesium citrate LIQUID ORAL 20150731 OTC MONOGRAPH NOT FINAL part334 QUALITY CHOICE (Chain Drug Marketing Association) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 63868-945_77e0cd5d-ee86-4a22-bb22-953136742c9c 63868-945 HUMAN OTC DRUG QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, PRAMOXINE HYDROCHLORIDE OINTMENT TOPICAL 20120209 OTC MONOGRAPH FINAL part333B CHAIN DRUG MARKETING ASSOCIATION INC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g E 20171231 63868-947_53c9d44d-7fd1-4aaa-89d7-2fa8c10e26ad 63868-947 HUMAN OTC DRUG QUALITY CHOICE EXTRA STRENGTH ANTI ITCH DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20120213 OTC MONOGRAPH FINAL part336 CHAIN DRUG MARKETING ASSOCIATION INC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g E 20171231 63868-951_49aae62f-d4e8-4470-8600-da4df73aa5ac 63868-951 HUMAN OTC DRUG QUALITY CHOICE HEMORRHOIDAL MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part346 CHAIN DRUG MARKETING ASSOCIATION INC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 140; 719; 2.5; 30 mg/g; mg/g; mg/g; mg/g E 20171231 63868-953_7ab086a1-dc03-411f-a2e6-ab1211ec9ba1 63868-953 HUMAN OTC DRUG Quality Choice Maximum Strength Oral Pain Relieving BENZOCAINE GEL TOPICAL 20130531 OTC MONOGRAPH NOT FINAL part356 Chain Drug Marketing Association Inc BENZOCAINE 20 g/100g N 20181231 63868-957_983e2ce1-25c0-4bab-85b3-80c53b3ee702 63868-957 HUMAN OTC DRUG Cough Relief Cough Suppressant Dextromethorphan HBr LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 63868-958_875cea36-6a2f-4175-bc40-188031ce3e84 63868-958 HUMAN OTC DRUG Flu Relief Therapy Nighttime Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 63868-960_bcd18b1e-9db6-480b-b374-2fcabe3deed7 63868-960 HUMAN OTC DRUG QUALITY CHOICE BACITRACIN BACITRACIN OINTMENT TOPICAL 20120213 OTC MONOGRAPH FINAL part333B CHAIN DRUG MARKETING ASSOCIATION INC BACITRACIN 500 [USP'U]/g N 20181231 63868-961_8792c569-9ffb-4b95-95dc-01fb961475cc 63868-961 HUMAN OTC DRUG Menstrual Pain Relief Maximum Strength Acetaminophen, Pamabrom, Pyrilamine Maleate TABLET, FILM COATED ORAL 20150113 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 63868-962_774b2177-ec37-46e6-bec8-fc06d491c46f 63868-962 HUMAN OTC DRUG Multi Symptom Cold Childrens Plus Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride SUSPENSION ORAL 20150930 OTC MONOGRAPH FINAL part341 QUALITY CHOICE (Chain Drug Marketing Association) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 63868-964_18f49be0-7363-4791-8e46-ffc2a11e7286 63868-964 HUMAN OTC DRUG Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160303 ANDA ANDA090922 Chain Drug Marketing Association, Inc. CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 63868-965_cf4cdefd-b7bb-4d22-a4fe-d03b480f78bd 63868-965 HUMAN OTC DRUG Quality Choice Vaginal Anti-Itch Maximum Strength Benzocaine and Resorcinol CREAM TOPICAL 20140428 OTC MONOGRAPH NOT FINAL part348 Chain Drug Marketing Association (CDMA) BENZOCAINE; RESORCINOL 200; 30 mg/g; mg/g N 20191231 63868-966_0ff0fd5c-1f86-47a0-9a5b-22741e8e2c21 63868-966 HUMAN OTC DRUG Allerfed Cold and Allergy Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20050722 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 63868-967_eadfb65d-e5e5-4913-a411-205b9587310d 63868-967 HUMAN OTC DRUG QUALITY CHOICE LUBRICANT TEARS EYE GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 SOLUTION/ DROPS OPHTHALMIC 20120930 OTC MONOGRAPH FINAL part349 CHAIN DRUG MARKETING ASSOCIATION INC GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL N 20181231 63868-968_0e4d5583-a1fa-4792-b8af-7a7846d8bec9 63868-968 HUMAN OTC DRUG QUALITY CHOICE LUBRICANT EYE POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL SOLUTION/ DROPS OPHTHALMIC 20120930 OTC MONOGRAPH FINAL part349 CHAIN DRUG MARKETING ASSOCIATION INC POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 63868-969_50918b6e-da18-4610-9622-5f061fe14a10 63868-969 HUMAN OTC DRUG QUALITY CHOICE LUBRICATING EYE DROPS CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN SOLUTION OPHTHALMIC 20120930 OTC MONOGRAPH FINAL part349 CHAIN DRUG MARKETING ASSOCIATION INC CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20181231 63868-971_06a92a2e-9c17-2a7c-e054-00144ff88e88 63868-971 HUMAN OTC DRUG Pressure and Pain PE ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20070829 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 63868-972_06ac9e02-95c4-3046-e054-00144ff88e88 63868-972 HUMAN OTC DRUG Sinus Relief ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20071009 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 63868-974_b9dbe835-eb53-4c51-b6eb-50c57d939bbb 63868-974 HUMAN OTC DRUG Clotrimazole Antifungal clotrimazole CREAM TOPICAL 20070829 OTC MONOGRAPH FINAL part333C Chain Drug Marketing Association Inc. CLOTRIMAZOLE 10 mg/g E 20171231 63868-976_066f3051-06f6-62ea-e054-00144ff8d46c 63868-976 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20140521 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 63868-977_492aae4a-981f-4cd3-aac5-5ef838116e8c 63868-977 HUMAN OTC DRUG Quality Choice Ibuprofen 200 Ibuprofen TABLET ORAL 20140723 ANDA ANDA079129 Chain Drug Marketing Association IBUPROFEN 200 mg/1 N 20181231 63868-978_0d58dfa3-1dd3-4074-ad83-3aae6b6bb5f0 63868-978 HUMAN OTC DRUG Quality Choice Extra Strength Pain Relief Acetaminophen TABLET ORAL 20140823 OTC MONOGRAPH NOT FINAL part343 Chain Drug Marketing Association ACETAMINOPHEN 500 mg/1 N 20181231 63868-979_931ee33d-3923-47a5-8179-3e6e29ab000d 63868-979 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 CHAIN DRUG MARKETING ASSOCIATION INC IBUPROFEN 200 mg/1 N 20181231 63868-980_49f8ee6f-e84b-41dd-b034-2a4eb12043f9 63868-980 HUMAN OTC DRUG Sterile Alcohol Isopropyl alcohol SWAB TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part333A Chain Drug Marketing Association Inc ISOPROPYL ALCOHOL .7 mL/1 N 20181231 63868-981_06ac9e02-9586-3046-e054-00144ff88e88 63868-981 HUMAN OTC DRUG Allergy Multi-Symptom ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20080801 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 63868-983_06ba032d-b59b-115f-e054-00144ff88e88 63868-983 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20120827 ANDA ANDA079129 Chain Drug Marketing Association IBUPROFEN 200 mg/1 N 20181231 63868-984_06a92a2e-9c2b-2a7c-e054-00144ff88e88 63868-984 HUMAN OTC DRUG Sinus Congestion and Pain ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20070829 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 63868-985_06ac99ec-0f1c-61ed-e054-00144ff8d46c 63868-985 HUMAN OTC DRUG Allergy Relief Plus Sinus Headache Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20071128 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 63868-987_be1fd297-5f34-41ff-ac23-cf2eb3728c5f 63868-987 HUMAN OTC DRUG Pain Relief Extra Strength, Non-Aspirin Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 CHAIN DRUG MARKETING ASSOCIATION INC ACETAMINOPHEN 500 mg/1 N 20181231 63868-995_c6c9cb0a-75a4-4a18-874e-5d87cf6bfc58 63868-995 HUMAN OTC DRUG Dye-Free Allergy Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20010913 20180713 OTC MONOGRAPH FINAL part341 CHAIN DRUG MARKETING ASSOCIATION INC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 63868-998_14646797-4241-40a6-a025-4be29a4d803b 63868-998 HUMAN OTC DRUG Quality Choice Mucus Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 Chain Drug Marketing Association GUAIFENESIN 400 mg/1 N 20181231 63874-087_12c7793d-11c5-4f1b-883b-04e7aed3fb5c 63874-087 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20100101 ANDA ANDA076286 Altura Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 63874-101_2234ef41-dd5f-46b3-aa17-8f8fd30add38 63874-101 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100101 ANDA ANDA065291 Altura Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 E 20171231 63874-102_2234ef41-dd5f-46b3-aa17-8f8fd30add38 63874-102 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100101 ANDA ANDA065291 Altura Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 E 20171231 63874-111_b4cebeeb-b014-4e9d-a865-4f09e4473c36 63874-111 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100101 ANDA ANDA065215 Altura Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 E 20171231 63874-112_b4cebeeb-b014-4e9d-a865-4f09e4473c36 63874-112 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20100101 ANDA ANDA065215 Altura Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 E 20171231 63874-279_4861231c-7aeb-49d5-9309-4e2855039a78 63874-279 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20100101 ANDA ANDA040358 Altura Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 660; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 63874-301_feb7a143-ac2f-48fd-a2d1-1475337efacf 63874-301 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100101 ANDA ANDA078250 Altura Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63874-322_1fbfeaff-19c8-4475-8da3-7e556c7e9104 63874-322 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100101 ANDA ANDA078558 Altura Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63874-323_1fbfeaff-19c8-4475-8da3-7e556c7e9104 63874-323 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100101 ANDA ANDA078558 Altura Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63874-324_1fbfeaff-19c8-4475-8da3-7e556c7e9104 63874-324 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100101 ANDA ANDA078558 Altura Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63874-325_feb7a143-ac2f-48fd-a2d1-1475337efacf 63874-325 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100101 ANDA ANDA078250 Altura Pharmaceuticals, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63874-326_feb7a143-ac2f-48fd-a2d1-1475337efacf 63874-326 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100101 ANDA ANDA078250 Altura Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63874-339_feb7a143-ac2f-48fd-a2d1-1475337efacf 63874-339 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20100101 ANDA ANDA078314 Altura Pharmaceuticals, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63874-413_66fa987f-47df-49ff-ab90-8b1e2bd3319c 63874-413 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20100101 NDA NDA011757 Altura Pharmaceuticals, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 63874-489_feb7a143-ac2f-48fd-a2d1-1475337efacf 63874-489 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20100101 ANDA ANDA078314 Altura Pharmaceuticals, Inc. NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63874-532_48b18a1e-404e-4b1e-b539-94d6993c8a76 63874-532 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100101 ANDA ANDA076003 Altura Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 63874-553_094625fc-2d69-4268-8c79-7519eafe1051 63874-553 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20100101 ANDA ANDA075410 Altura Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 63874-607_c445da39-f7f2-46a9-871f-a25f1c0f462f 63874-607 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20100101 ANDA ANDA076009 Altura Pharmaceuticals, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63874-687_c445da39-f7f2-46a9-871f-a25f1c0f462f 63874-687 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET ORAL 20100101 ANDA ANDA076009 Altura Pharmaceuticals, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 63874-834_4861231c-7aeb-49d5-9309-4e2855039a78 63874-834 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20100101 ANDA ANDA040355 Altura Pharmaceuticals, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 63900-130_1eda55f3-612f-69ec-e054-00144ff8d46c 63900-130 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20150903 OTC MONOGRAPH NOT FINAL part333E Simoniz USA, Inc. ALCOHOL 62 mL/100mL N 20181231 63903-0110_968aa835-1017-4243-95a3-e7920b796ff0 63903-0110 HUMAN OTC DRUG DECORTE SHEER BRILLIANCE 10 Octinoxate, Zinc Oxide LOTION TOPICAL 20170901 OTC MONOGRAPH FINAL part352 KOSÉ CORPORATION OCTINOXATE; ZINC OXIDE 3.9; 3.8 g/50mL; g/50mL N 20181231 63903-0120_968aa835-1017-4243-95a3-e7920b796ff0 63903-0120 HUMAN OTC DRUG DECORTE SHEER BRILLIANCE 20 Octinoxate, Zinc Oxide LOTION TOPICAL 20170901 OTC MONOGRAPH FINAL part352 KOSÉ CORPORATION OCTINOXATE; ZINC OXIDE 3.9; 3.8 g/50mL; g/50mL N 20181231 63903-0130_968aa835-1017-4243-95a3-e7920b796ff0 63903-0130 HUMAN OTC DRUG DECORTE SHEER BRILLIANCE 30 Octinoxate, Zinc Oxide LOTION TOPICAL 20170901 OTC MONOGRAPH FINAL part352 KOSÉ CORPORATION OCTINOXATE; ZINC OXIDE 3.9; 3.8 g/50mL; g/50mL N 20181231 63903-0140_968aa835-1017-4243-95a3-e7920b796ff0 63903-0140 HUMAN OTC DRUG DECORTE SHEER BRILLIANCE 40 Octinoxate, Zinc Oxide LOTION TOPICAL 20170901 OTC MONOGRAPH FINAL part352 KOSÉ CORPORATION OCTINOXATE; ZINC OXIDE 4; 3.9 g/50mL; g/50mL N 20181231 63917-001_06c65b8d-2b1d-414f-af88-cee1ae547a03 63917-001 HUMAN PRESCRIPTION DRUG Carbon Dioxide Carbon Dioxide GAS RESPIRATORY (INHALATION) 20091229 NDA NDA205846 Airgas Carbonic, Inc. CARBON DIOXIDE 1000 mL/L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 63922-222_2be7ff9e-918c-4424-95e9-8f74f79b1f37 63922-222 HUMAN OTC DRUG Sun Moon Star Pain Relieving Menthol Methyl Salicylate PATCH TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part348 Kingsway Trading MENTHOL; METHYL SALICYLATE 16; 15 g/1; g/1 E 20171231 63922-223_2e44aaf1-34f7-0bf6-e054-00144ff8d46c 63922-223 HUMAN OTC DRUG KGS Zhitong Gao Medicated Plaster Extra Strength Methyl Salicylate Menthol Camphor PATCH TOPICAL 20160314 OTC MONOGRAPH NOT FINAL part348 Kingsway Trading Inc. METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 13; 9; 11 g/1; g/1; g/1 N 20181231 63922-224_339b5af6-9091-1c8f-e054-00144ff8d46c 63922-224 HUMAN OTC DRUG KGS Bao Zhen Gao Medicated Plaster Extra Strength Methyl Salicylate Menthol Camphor PATCH TOPICAL 20160509 OTC MONOGRAPH NOT FINAL part348 Kingsway Trading Inc. METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 14; 7; 7 g/1; g/1; g/1 N 20181231 63922-600_728cbd00-b190-41ef-a848-7d8766e5d878 63922-600 HUMAN OTC DRUG Ganmaoling 999 Acetaminophen Caffeine Chlorpheniramine Maleate GRANULE ORAL 20120630 OTC MONOGRAPH FINAL part341 Kingsway Trading ACETAMINOPHEN; CAFFEINE; CHLORPHENIRAMINE MALEATE 200; 4; 4 mg/1; mg/1; mg/1 E 20171231 63922-601_db0a71dd-c5fa-4580-b085-9895586d953a 63922-601 HUMAN OTC DRUG 999 GANMAOLING Cold Acetaminophen Caffeine Chlorpheniramine Maleate CAPSULE ORAL 20120730 OTC MONOGRAPH FINAL part341 Kingsway ACETAMINOPHEN; CAFFEINE; CHLORPHENIRAMINE MALEATE 100; 2; 2 mg/1; mg/1; mg/1 E 20171231 63922-605_dc8d6626-3092-43cb-94c8-a2a02d4b321b 63922-605 HUMAN OTC DRUG KGS ALLERGY SOOTHING Acetaminophen Chlorpheniramine Maleate CAPSULE, DELAYED RELEASE PELLETS ORAL 20140130 OTC MONOGRAPH FINAL part341 Kingsway ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 250; 2 mg/1; mg/1 E 20171231 63926-5660_6a4e3444-b00b-4080-b038-6b840e9a1bce 63926-5660 HUMAN OTC DRUG Hand Sanitizer isopropyl Alcohol SPRAY TOPICAL 20090330 UNAPPROVED DRUG OTHER ProActive Solutions USA, LLC ISOPROPYL ALCOHOL 75 kg/100kg E 20171231 63936-0875_a771064f-cf60-4bec-aa3b-efd0d26a13ae 63936-0875 HUMAN OTC DRUG Stopain Extra Strength Pain Relieving MENTHOL GEL TOPICAL 20150212 OTC MONOGRAPH NOT FINAL part348 Troy Manufacturing, Inc. MENTHOL .08 g/g N 20181231 63936-0975_60dc7710-0ed7-0a51-e053-2991aa0a16ff 63936-0975 HUMAN OTC DRUG Stopain Clinical MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20170119 OTC MONOGRAPH NOT FINAL part348 Troy Manufacturing, Inc. MENTHOL, UNSPECIFIED FORM .1 g/g N 20181231 63936-8504_39130cfa-97ce-4fa5-891f-42aec5f5567e 63936-8504 HUMAN OTC DRUG EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING MENTHOL SPRAY TOPICAL 20101013 OTC MONOGRAPH NOT FINAL part348 TROY MANUFACTURING, INC MENTHOL 8 mL/100mL N 20181231 63936-8508_60dc8226-ae8d-232e-e053-2991aa0aa05e 63936-8508 HUMAN OTC DRUG ULTRA STRENGTH STOPAIN PAIN RELIEVING MENTHOL SPRAY TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part348 TROY MANUFACTURING MENTHOL 80 mg/mL N 20191231 63936-8523_1d87acef-9832-4616-bf82-41188d6770a1 63936-8523 HUMAN OTC DRUG EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON MENTHOL LIQUID TOPICAL 20101013 OTC MONOGRAPH NOT FINAL part348 TROY MANUFACTURING, INC MENTHOL 8 mL/100mL N 20181231 63936-8558_8ec6d844-d418-49b8-8755-6138e8d77989 63936-8558 HUMAN OTC DRUG STOPAIN COLD PAIN RELIEVING MENTHOL SPRAY TOPICAL 20101013 OTC MONOGRAPH NOT FINAL part348 TROY MANUFACTURING, INC MENTHOL 6 mL/100mL N 20181231 63936-8582_60dc6adb-2d66-fdab-e053-2991aa0ab0dc 63936-8582 HUMAN OTC DRUG STOPAIN COLD PAIN RELIEVING MENTHOL GEL TOPICAL 20101203 OTC MONOGRAPH NOT FINAL part348 Troy Manufacturing, Inc. MENTHOL 6 g/100g N 20181231 63936-8700_10870dee-2872-4417-aea8-0dd63cd50251 63936-8700 HUMAN OTC DRUG Stopain Migraine Pain Relieving MENTHOLUM, BELLADONNA, IRIS VERSICOLOR, SANGUINARIA CANADENSIS GEL TOPICAL 20150320 UNAPPROVED HOMEOPATHIC TROY MANUFACTURING, INC MENTHOL, UNSPECIFIED FORM; ATROPA BELLADONNA; IRIS VERSICOLOR ROOT; SANGUINARIA CANADENSIS ROOT 1; 3; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL N 20181231 63936-8750_34cacb79-b481-4583-8500-c3e0ea891c7e 63936-8750 HUMAN OTC DRUG Stopain Cold Professional Strength Pain Relieving MENTHOL GEL TOPICAL 20140703 OTC MONOGRAPH NOT FINAL part348 TROY MANUFACTURING, INC MENTHOL 80 mg/g N 20181231 63936-9500_60dc6adb-2d7b-fdab-e053-2991aa0ab0dc 63936-9500 HUMAN OTC DRUG Stopain Clinical MENTHOL, UNSPECIFIED FORM SPRAY TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part348 Troy Manufacturing, Inc. MENTHOL, UNSPECIFIED FORM 100 mg/mL N 20181231 63936-9520_60dc6adb-2d87-fdab-e053-2991aa0ab0dc 63936-9520 HUMAN OTC DRUG Stopain Clinical Roll-On MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part348 Troy Manufacturing, Inc. MENTHOL, UNSPECIFIED FORM 100 g/mL N 20181231 63936-9750_60dc7710-0eeb-0a51-e053-2991aa0a16ff 63936-9750 HUMAN OTC DRUG Stopain Clinical MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part348 Troy Manufacturing, Inc. MENTHOL, UNSPECIFIED FORM 100 g/mL N 20181231 63937-2364_485f86b6-284f-4b82-87fd-2d8a22ebc0a9 63937-2364 HUMAN OTC DRUG SANIMOR ALCOHOL-FREE FOAMING HAND SANITIZER Benzalkonium Chloride LIQUID TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part333E Avmor BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63940-000_b4420c1e-7312-453e-99c4-ee0af0a58d98 63940-000 HUMAN OTC DRUG Harmon Face Values Daily Facial Avobenzone and Octocrylene CREAM TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part352 Harmon Stores Inc. AVOBENZONE; OCTOCRYLENE 3; 10 mL/100mL; mL/100mL N 20181231 63940-003_5f0f2bb2-637d-6b63-e053-2991aa0ac4f4 63940-003 HUMAN OTC DRUG Undecylenic Acid Antifungal Pen LIQUID TOPICAL 20140218 OTC MONOGRAPH FINAL part333C Harmon Store Inc. UNDECYLENIC ACID 25 mg/1.7mL N 20181231 63940-004_48cea774-b411-4336-95b0-9f602bc47f4e 63940-004 HUMAN OTC DRUG Anticavity Sodium fluoride RINSE ORAL 20150224 OTC MONOGRAPH FINAL part355 Harmon Stores, Inc SODIUM FLUORIDE .2 mg/mL N 20191231 63940-006_5f3a32ad-58f9-0c2d-e053-2991aa0ad0cb 63940-006 HUMAN OTC DRUG Tolnaftate Athletes Foot Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20120214 OTC MONOGRAPH FINAL part333C Harmon Store Inc. TOLNAFTATE 1.5 g/150g N 20181231 63940-008_5f3a6c73-45c4-0b5a-e053-2991aa0a2eca 63940-008 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20120117 OTC MONOGRAPH FINAL part358F Harmon Store Inc. SALICYLIC ACID 40 mg/91 N 20181231 63940-010_5f3a88b2-29d0-8b60-e053-2a91aa0aeb76 63940-010 HUMAN OTC DRUG Salicylic Acid Extra Thick Callus Remover PATCH TOPICAL 20140218 OTC MONOGRAPH FINAL part358F Harmon Store Inc. SALICYLIC ACID 40 mg/41 N 20181231 63940-011_5f3ac448-4096-d4f4-e053-2a91aa0a67be 63940-011 HUMAN OTC DRUG Tolnaftate Foot Odor Control Powder Spray AEROSOL, SPRAY TOPICAL 20120127 OTC MONOGRAPH FINAL part333C Harmon Store Inc. TOLNAFTATE 1.3 g/113g N 20181231 63940-012_5f3ac734-952b-77b7-e053-2991aa0a6431 63940-012 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20120214 OTC MONOGRAPH NOT FINAL part333A Harmon Store Inc. BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/10mL; mg/10mL N 20181231 63940-014_5f3b00a4-7bad-cc13-e053-2991aa0a420d 63940-014 HUMAN OTC DRUG Menthol Maximum Strength Medicated Foot Powder POWDER TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part348 Harmon Store Inc. MENTHOL 2.8 g/283g N 20181231 63940-015_cd972d66-a1be-4b73-a3e1-dba238c022b1 63940-015 HUMAN OTC DRUG Miconazole Nitrate Moisture Absorbing MiconazorbAF Antifungal Powder POWDER TOPICAL 20140127 OTC MONOGRAPH FINAL part333C Harmon Store Inc. MICONAZOLE NITRATE 1.42 g/71g N 20181231 63940-016_5f3b2c58-c3b3-50e4-e053-2a91aa0a33c7 63940-016 HUMAN OTC DRUG Salicylic Acid One Step Corn Remover PATCH TOPICAL 20120328 OTC MONOGRAPH FINAL part358F Harmon Store Inc. SALICYLIC ACID 40 mg/61 N 20181231 63940-017_5f3b2c58-c3c5-50e4-e053-2a91aa0a33c7 63940-017 HUMAN OTC DRUG Salicylic Acid One Step Wart Remover Clear Strips PLASTER TOPICAL 20140218 OTC MONOGRAPH FINAL part358B Harmon Store Inc. SALICYLIC ACID 40 mg/141 N 20181231 63940-018_5f3b3a65-db02-1a74-e053-2a91aa0a746d 63940-018 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20120105 OTC MONOGRAPH FINAL part358F Harmon Store Inc. SALICYLIC ACID 40 mg/91 N 20181231 63940-019_5f3b6e5c-831a-2f0d-e053-2a91aa0a7d0f 63940-019 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20150924 OTC MONOGRAPH FINAL part358F Harmon Store Inc SALICYLIC ACID .17 g/9mL N 20181231 63940-020_a7cfdd37-8b4e-42ee-83d0-ea436b7a8f34 63940-020 HUMAN OTC DRUG Diaper Rash Zinc oxide PASTE TOPICAL 20130305 OTC MONOGRAPH FINAL part347 Harmon Stores, Inc ZINC OXIDE 532 mg/g N 20181231 63940-021_5f3ad1d8-24cc-cd6f-e053-2a91aa0a5e18 63940-021 HUMAN OTC DRUG Salicylic Acid Corn and Callus Remover Liquid LIQUID TOPICAL 20150924 OTC MONOGRAPH FINAL part358F Harmon Store Inc. SALICYLIC ACID .17 mg/9.8mL N 20181231 63940-022_5f3a0dbd-da9a-70a4-e053-2a91aa0a9dc5 63940-022 HUMAN OTC DRUG Allantoin Advanced Derma Therapy SPRAY TOPICAL 20150904 OTC MONOGRAPH FINAL part347 Harmon Store Inc. ALLANTOIN .425 g/85g N 20181231 63940-023_5f9b83dd-8beb-39ca-e053-2a91aa0aad5a 63940-023 HUMAN OTC DRUG Salicylic Acid Wart Remover Gel Pen GEL TOPICAL 20150901 OTC MONOGRAPH FINAL part358B Harmon Store Inc. SALICYLIC ACID .17 g/g N 20181231 63940-024_5f3ac448-40a8-d4f4-e053-2a91aa0a67be 63940-024 HUMAN OTC DRUG Diphenhydramine HCl and Zinc Acetate Extra Strength Itch Relief SPRAY TOPICAL 20120403 OTC MONOGRAPH NOT FINAL part348 Harmon Store Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.52; .076 g/76g; g/76g N 20181231 63940-025_5f0f1549-acab-35c3-e053-2a91aa0af3ae 63940-025 HUMAN OTC DRUG Miconazole Nitrate Antifungal Liquid Continuous Spray AEROSOL, SPRAY TOPICAL 20120117 OTC MONOGRAPH FINAL part333C Harmon Store Inc. MICONAZOLE NITRATE 3 g/150g N 20181231 63940-026_5f3a770d-238c-64f2-e053-2991aa0aaf73 63940-026 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20120117 OTC MONOGRAPH FINAL part358F Harmon Store Inc. SALICYLIC ACID 40 mg/41 N 20181231 63940-027_c385c4c5-0b71-480a-b1ef-93e7db0af702 63940-027 HUMAN OTC DRUG Undecylenic Acid Antifungal Solution LIQUID TOPICAL 20131120 OTC MONOGRAPH FINAL part333C Harmon Store Inc. UNDECYLENIC ACID 7.5 g/30g N 20181231 63940-043_550b532b-0ecf-449a-a809-5d4400eee579 63940-043 HUMAN OTC DRUG Core Values Allergy Relief Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20161122 ANDA ANDA078336 Harmon Stores Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 63940-055_a143c5ec-932a-43b1-b1bf-2c4ee85809a7 63940-055 HUMAN OTC DRUG FACE VALUES FRESH SCENT Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc. BENZALKONIUM CHLORIDE .115 g/1 N 20181231 63940-069_e39501d2-13f8-42fb-8d15-0132ef68c6c6 63940-069 HUMAN OTC DRUG Petrolatum White Petrolatum JELLY TOPICAL 19930316 OTC MONOGRAPH FINAL part347 Liberty Procurement, Inc PETROLATUM 1 g/g N 20181231 63940-072_7b77c116-2b77-412e-a4ce-b80ca0bcb0be 63940-072 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19951009 OTC MONOGRAPH NOT FINAL part356 Harmon Stores Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63940-087_6292c867-6951-4bd7-9b6a-545bada4133a 63940-087 HUMAN OTC DRUG Core Values Tussin DM Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20161122 OTC MONOGRAPH FINAL part341 Harmon Stores Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 63940-090_4932b1c8-e299-3327-e054-00144ff8d46c 63940-090 HUMAN OTC DRUG menthol cough drop menthol LOZENGE ORAL 20151210 OTC MONOGRAPH FINAL part341 Harmon Stores, Inc MENTHOL 5.4 mg/1 N 20181231 63940-091_60cafbaf-8ed7-46a5-e053-2a91aa0af11f 63940-091 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20151210 OTC MONOGRAPH FINAL part341 Harmon Stores MENTHOL 5.8 mg/1 N 20181231 63940-092_60cb0eea-5760-1aba-e053-2991aa0a80b9 63940-092 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20151210 OTC MONOGRAPH FINAL part341 Harmon Stores MENTHOL 7.5 mg/1 N 20181231 63940-093_60cb0483-4ced-0fa3-e053-2991aa0a5795 63940-093 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20151210 OTC MONOGRAPH FINAL part341 Harmon Stores MENTHOL 7.5 mg/1 N 20181231 63940-094_60cadfd9-ff03-d005-e053-2991aa0aadea 63940-094 HUMAN OTC DRUG sugar free cherry cough drops menthol LOZENGE ORAL 20151210 OTC MONOGRAPH FINAL part341 Harmon Stores MENTHOL 5.8 mg/1 N 20181231 63940-095_60db36bf-a1e3-743a-e053-2a91aa0a0e25 63940-095 HUMAN OTC DRUG menthol cough drops Menthol LOZENGE ORAL 20171221 OTC MONOGRAPH FINAL part341 Bed Bath & Beyond MENTHOL 5.4 mg/1 N 20181231 63940-100_be9a8ace-4619-4aad-84f5-377b129bdeff 63940-100 HUMAN OTC DRUG HARMON Extra Strength Pain Relieving MENTHOL GEL TOPICAL 20120905 OTC MONOGRAPH FINAL part348 Harmon Stores Inc. MENTHOL 3.5 mL/100mL N 20181231 63940-101_d7ad8e2c-347b-4be3-993a-e4f89734541e 63940-101 HUMAN OTC DRUG harmon face values allergy relief Loratadine TABLET ORAL 20111218 ANDA ANDA076301 Harmon Stores Inc. LORATADINE 10 mg/1 N 20181231 63940-104_e6b7fc10-35a0-47a5-9ab5-48130384f832 63940-104 HUMAN OTC DRUG Pain Reliever Regular Strength Acetaminophen TABLET ORAL 19900713 OTC MONOGRAPH NOT FINAL part343 Harmon Store Inc. ACETAMINOPHEN 325 mg/1 N 20181231 63940-111_d663cd44-6f16-478c-a7d2-2ac7316f1023 63940-111 HUMAN OTC DRUG Instant Hand Sanitizer Harmon Ethyl Alcohol 65.00% LIQUID TOPICAL 20160209 OTC MONOGRAPH NOT FINAL part333A Harmon ALCOHOL 65 g/100g N 20181231 63940-113_65d9f107-4c40-405d-8ca1-e17d1a826c68 63940-113 HUMAN OTC DRUG buybuyBABY quick relief diaper rash cream ZINC OXIDE CREAM TOPICAL 20161207 OTC MONOGRAPH FINAL part347 Harmon Stores Inc. ZINC OXIDE 14.69 g/113g N 20181231 63940-119_b2f66637-0b8a-4f96-82f7-a08d7aa50504 63940-119 HUMAN OTC DRUG core values anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20170728 ANDA ANDA075232 Harmon Stores Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20191231 63940-121_91280594-08bc-4d09-9346-3ea9d93bf1dc 63940-121 HUMAN OTC DRUG Face Values - AM Facial Moisturizing Broad Spectrum SPF30 Sunscreen Homosalate, Octinoxate, Octocrylene, Zinc Oxide LOTION TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 Harmon Stores Inc HOMOSALATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 12; 7.5; 2; 3.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 63940-131_f9598796-cb06-461f-b75d-cdfc145abc70 63940-131 HUMAN OTC DRUG Core Values Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20161122 OTC MONOGRAPH FINAL part341 Harmon Stores Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 63940-150_73ea9d17-16a8-46af-b6dc-13f678a7b2dc 63940-150 HUMAN OTC DRUG HARMON Extra Strength Pain Relieving Roll-On MENTHOL GEL TOPICAL 20120905 OTC MONOGRAPH FINAL part348 Harmon Stores Inc. MENTHOL 3.5 mL/100mL N 20181231 63940-163_f9121e8f-2ca3-483c-8c5c-ad1fd228d2bb 63940-163 HUMAN OTC DRUG Anticavity SODIUM FLUORIDE MOUTHWASH ORAL 20160706 OTC MONOGRAPH FINAL part355 Liberty Procurement, Inc SODIUM FLUORIDE .1 mg/mL N 20181231 63940-174_bc239080-7df8-4f45-80c6-4736f822350b 63940-174 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20150731 NDA NDA021920 Harmon Stores NAPROXEN SODIUM 220 mg/1 N 20181231 63940-175_2f22ecbe-59c6-4d9b-848b-6403c245dac6 63940-175 HUMAN OTC DRUG harmon face values pain and fever Acetaminophen SUSPENSION ORAL 20111218 OTC MONOGRAPH NOT FINAL part343 Harmon Stores Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 63940-194_9d472365-5e7d-47fe-90b3-c344f42bb2ba 63940-194 HUMAN OTC DRUG Allergy Relief Chlorpheniramine maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Harmon Store Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 63940-198_8e436d7b-10b2-4435-82af-2a376fa2ba6e 63940-198 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Harmon Store Inc. DIMENHYDRINATE 50 mg/1 N 20181231 63940-199_b9087180-884a-4f8f-b303-4e7c2294289c 63940-199 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20140831 ANDA ANDA078682 Harmon Stores IBUPROFEN 200 mg/1 N 20181231 63940-202_c9c33ff8-ad50-4f5b-a171-7243db072c12 63940-202 HUMAN OTC DRUG harmon face values minoxidil minoxidil SOLUTION TOPICAL 20111218 ANDA ANDA075357 Harmon Stores Inc. MINOXIDIL 2 g/100mL N 20181231 63940-211_d0951b11-baa4-44d4-9d90-4174c473e20f 63940-211 HUMAN OTC DRUG Allergy Relief Cetirizine HCl CAPSULE ORAL 20150228 NDA NDA022429 Harmon Stores CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 63940-213_21f53880-32ad-4dff-b795-dc105e495a88 63940-213 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20160706 OTC MONOGRAPH FINAL part355 Liberty Procurement, Inc SODIUM FLUORIDE .2 mg/mL N 20181231 63940-218_8ce12a71-ed3d-420a-bb0b-15e67772b671 63940-218 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 Harmon Store Inc. ASPIRIN 81 mg/1 N 20181231 63940-219_1f499d0d-9d7c-4814-a8ae-69f58db6bd46 63940-219 HUMAN OTC DRUG core values childrens ibuprofen Ibuprofen SUSPENSION ORAL 20171114 ANDA ANDA074937 Harmon Stores Inc. IBUPROFEN 100 mg/5mL N 20181231 63940-224_40555c92-0968-471c-88ea-b9f0033af11f 63940-224 HUMAN OTC DRUG harmon face values anti diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20111218 ANDA ANDA075232 Harmon Stores Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 63940-226_46d5acbd-49bf-4003-bf27-4a9e690a86c3 63940-226 HUMAN OTC DRUG Diaper Rash Zinc oxide CREAM TOPICAL 20130215 OTC MONOGRAPH NOT FINAL part348 Harmon Stores Inc ZINC OXIDE 130 mg/g N 20181231 63940-229_8344e120-88e3-4307-abc3-b92a4b0dbbb6 63940-229 HUMAN OTC DRUG Alertness Aid Maximum Strength Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 Harmon Store Inc. CAFFEINE 200 mg/1 N 20181231 63940-235_8565b92b-1111-4d05-a7a1-78c5f658fca8 63940-235 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 OTC MONOGRAPH NOT FINAL part343 Harmon Store Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 63940-242_2e7d807b-430a-47c1-b246-015567b50ed1 63940-242 HUMAN OTC DRUG Core Values Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20161122 NDA NDA022032 Harmon Stores Inc. OMEPRAZOLE 20 mg/1 N 20181231 63940-291_2f0813e5-7929-4cde-bbf9-6aa665febca6 63940-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Harmon Store Inc. IBUPROFEN 200 mg/1 N 20181231 63940-292_b9e9bfff-bde5-407e-b72b-82b0975b5566 63940-292 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Harmon Store Inc. IBUPROFEN 200 mg/1 N 20181231 63940-294_2810af79-02b3-4a6f-9488-cbd0b851253b 63940-294 HUMAN OTC DRUG harmon face values minoxidil mens Minoxidil AEROSOL, FOAM TOPICAL 20150714 ANDA ANDA091344 Harmon Stores Inc. MINOXIDIL 5 g/100g N 20181231 63940-299_aa22572b-0762-444a-b068-34a97181c9ed 63940-299 HUMAN OTC DRUG Antiseptic Cetylpyridinium chloride MOUTHWASH ORAL 20160711 OTC MONOGRAPH NOT FINAL part356 Liberty Procurement, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 63940-309_6f5f917d-f320-4324-9782-914ce6c7dc3f 63940-309 HUMAN OTC DRUG core values pain and fever Acetaminophen SUSPENSION ORAL 20171106 OTC MONOGRAPH NOT FINAL part343 Harmon Stores Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 63940-310_74375c1e-5b18-42be-bcb7-9d85388da5f1 63940-310 HUMAN OTC DRUG Quick Wrinkle Repair Moisturizer Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part352 Harmon Stores Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 4; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 63940-318_68bf49a4-ed77-4ef4-aa76-10fc2b608e40 63940-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20160620 OTC MONOGRAPH NOT FINAL part356 Liberty Procurement, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63940-319_b09abecc-3018-489c-a65c-e540802e7dc9 63940-319 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 19980716 OTC MONOGRAPH FINAL part335 Harmon Store Inc. BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 63940-327_ca017057-096d-4c49-86dc-9f52dcecd251 63940-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET, COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Harmon Store Inc. BISACODYL 5 mg/1 N 20191231 63940-329_aa3bef13-9114-43c3-bb13-d0064ee0a870 63940-329 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, FILM COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 Harmon Store Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63940-334_2e612f97-9c36-485d-95f9-02151c7c6ff6 63940-334 HUMAN OTC DRUG Harmon Face Values Daily Moisturizing Dimethicone LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part347 Harmon Stores Inc. DIMETHICONE 1.25 g/100mL N 20181231 63940-335_93d2312b-ff2d-444b-a884-c3acac261a43 63940-335 HUMAN OTC DRUG harmon face values night time relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20120113 OTC MONOGRAPH FINAL part341 Harmon Stores Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 63940-336_fc4049ec-2e56-4092-b39c-46720bc5ecf8 63940-336 HUMAN OTC DRUG Calamine Calamine, Pramoxind HCl LOTION TOPICAL 20160908 OTC MONOGRAPH FINAL part347 Liberty Procurement, Inc FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 8.6; 20; 10 mg/mL; mg/mL; mg/mL N 20181231 63940-343_4db80eb6-0cb6-43a0-a808-ff69538dff80 63940-343 HUMAN OTC DRUG A D and L Original Diaper Rash Skin Lanolin, Petrolatum OINTMENT TOPICAL 20140901 OTC MONOGRAPH FINAL part347 Harmon Stores Inc. LANOLIN; PETROLATUM 15.5; 53.4 g/100g; g/100g N 20181231 63940-358_88399c8a-146d-48a3-825c-f65994d81ec4 63940-358 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20150202 OTC MONOGRAPH NOT FINAL part333A Harmon Stores, Inc BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 63940-359_d207e13e-a87d-466d-b102-17d1fd108f4f 63940-359 HUMAN OTC DRUG Harmon Face Values Tussin DM Adult Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20111218 OTC MONOGRAPH FINAL part341 Harmon Stores Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 63940-367_45b8efdc-0136-4623-a9a4-15789b143e20 63940-367 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Harmon Store Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63940-370_ba5f48ce-9f0f-4f45-9b99-b5b3a43ff69b 63940-370 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333A Harmon Stores, Inc ALCOHOL 70 mL/100mL N 20181231 63940-375_4817ff2a-4e60-46e2-ab31-3b9543a1e1ae 63940-375 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 Harmon Store Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 63940-385_205a7034-b232-4162-a0d5-2246bf5f8dd6 63940-385 HUMAN OTC DRUG Core Values Minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20170517 ANDA ANDA091344 Harmon Stores Inc. MINOXIDIL 5 g/100g N 20181231 63940-387_842023b8-3587-4c51-8324-75d02e2ad6ed 63940-387 HUMAN OTC DRUG Harmon Face Values Revitalizing Day Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part352 Harmon Stores Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE 2; 5; 5 g/100g; g/100g; g/100g N 20181231 63940-392_04c1c023-c748-4f6d-b257-780d48fb9b3b 63940-392 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Harmon Store Inc. IBUPROFEN 200 mg/1 N 20181231 63940-400_2959e865-1b97-4f7c-9178-8d52a6b57f0f 63940-400 HUMAN OTC DRUG Core Values Night Time Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20170117 OTC MONOGRAPH FINAL part341 Harmon Stores Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 63940-404_ac4cfb68-dbff-4f9a-b4c7-3f96d8368806 63940-404 HUMAN OTC DRUG Night Time Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH FINAL part338 Harmon Stores DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63940-428_3dcfad7e-20f4-405e-b4f5-af36f8c60b35 63940-428 HUMAN OTC DRUG Tension Headache Relief Acetaminophen, Caffeine TABLET ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 Harmon Store Inc. ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 63940-429_970acac2-e16d-4d78-9570-37064147b250 63940-429 HUMAN OTC DRUG Baby Eczema Moisturizing Colloidal Oatmeal CREAM TOPICAL 20140901 OTC MONOGRAPH FINAL part347 Harmon Stores Inc. OATMEAL 1 g/100g N 20181231 63940-433_28b33138-2288-4e8e-aa6e-25f0dc9deffe 63940-433 HUMAN OTC DRUG Baby Daily Moisturizing Fragrance Free Dimethicone LOTION TOPICAL 20140901 OTC MONOGRAPH FINAL part347 Harmon Stores Inc. DIMETHICONE 1.2 g/100mL N 20181231 63940-434_f8cd3e89-a870-496b-8274-08762e0f500c 63940-434 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20160610 OTC MONOGRAPH NOT FINAL part356 Liberty Procurement, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63940-435_d2a86f71-406d-4421-bce5-2891caed9af5 63940-435 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20150915 OTC MONOGRAPH FINAL part355 Harmon Stores, Inc SODIUM FLUORIDE .2 mg/mL N 20181231 63940-439_f76deead-6e8f-41cb-92da-98eae5b14b4c 63940-439 HUMAN OTC DRUG Advanced Hand Sanitizer Alcohol GEL TOPICAL 20140218 OTC MONOGRAPH NOT FINAL part333A Harmon Stores, Inc ALCOHOL 616 mL/mL N 20181231 63940-453_6a5c2082-4b59-4e6c-9a7e-69550edbacb8 63940-453 HUMAN OTC DRUG Decongestant PE Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 Harmon Store Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 63940-458_ff37978b-e38d-4d4b-af89-e1764529b0bd 63940-458 HUMAN OTC DRUG harmon face values allergy relief Cetirizine Hydrochloride TABLET ORAL 20111218 ANDA ANDA078336 Harmon Stores Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 63940-459_6a15f126-0a9e-40f9-9877-9db459be37c3 63940-459 HUMAN OTC DRUG harmon face values night time relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20120223 OTC MONOGRAPH FINAL part341 Harmon Stores Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 63940-466_e9900b89-7d75-4676-98d0-fd211a34b62b 63940-466 HUMAN OTC DRUG Hand Wash Benzalkonium chloride SOAP TOPICAL 20160217 OTC MONOGRAPH NOT FINAL part333A Harmon Stores, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63940-472_653c1abf-a2e4-4d71-903d-bd16c1625b29 63940-472 HUMAN OTC DRUG Harmon Revitalizing Facial Smoother Immediate Skin Smoothing Finishing Broad Spectrum SPF30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 Harmon Stores Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 63940-482_bdd64f6b-f133-4df7-8ea9-811b7a010d0d 63940-482 HUMAN OTC DRUG Alcohol-Free Anticavity Sodium fluoride LIQUID ORAL 20161128 OTC MONOGRAPH FINAL part355 Liberty Procurement, Inc SODIUM FLUORIDE .1 mg/mL N 20181231 63940-491_2c1add53-490b-495e-b5e0-62a37f738f49 63940-491 HUMAN OTC DRUG Core Values Minoxidil minoxidil SOLUTION TOPICAL 20170517 ANDA ANDA075357 Harmon Stores Inc. MINOXIDIL 2 g/100mL N 20181231 63940-500_5f9f93ad-61e0-6854-e053-2a91aa0a6731 63940-500 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Powder Miconazole Nitrate Talc Free POWDER TOPICAL 20170415 OTC MONOGRAPH FINAL part333C Harmon Store Inc. MICONAZOLE NITRATE 1.42 g/71g N 20181231 63940-501_578207ee-bbf3-4e7d-838b-0246ccb351ce 63940-501 HUMAN OTC DRUG Core Values Allergy Relief Fluticasone propionate SPRAY, METERED NASAL 20170105 ANDA ANDA207957 Harmon Stores Inc. FLUTICASONE PROPIONATE 50 ug/1 N 20181231 63940-516_44b2297d-823d-4af7-8ef8-81d162800270 63940-516 HUMAN OTC DRUG harmon face values tussin cf Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20111218 OTC MONOGRAPH FINAL part341 Harmon Stores Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 63940-519_94adbf5d-74fb-47ee-9078-3b53c569a21d 63940-519 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Harmon Store Inc. ACETAMINOPHEN 500 mg/1 N 20181231 63940-521_48377ff4-20fc-4607-9833-a0addb5c3f87 63940-521 HUMAN OTC DRUG buybuyBABY advanced therapy skin protectant PETROLATUM OINTMENT TOPICAL 20161207 OTC MONOGRAPH FINAL part347 Harmon Stores Inc. PETROLATUM 34.85 g/85g N 20181231 63940-532_9b0a2854-af73-40ba-a8da-230fae368a9f 63940-532 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, FILM COATED ORAL 20051222 OTC MONOGRAPH FINAL part341 Harmon Store Inc. GUAIFENESIN 400 mg/1 N 20181231 63940-533_bab3b05c-f09f-4c4d-89f0-939f1b832d5f 63940-533 HUMAN OTC DRUG Mucus Relief Dextromethorphan HBr, Guaifenesin TABLET, COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 Harmon Store Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 63940-536_06f7c9ac-1abe-4d75-90e2-2f1a70aaae23 63940-536 HUMAN OTC DRUG Oil-Free Acne Wash Salicylic Acid SOLUTION TOPICAL 20131115 OTC MONOGRAPH FINAL part333D Harmon Stores Inc SALICYLIC ACID 2 g/100mL N 20181231 63940-540_87e5f3a3-70a3-4f9c-b369-abc395ed1d0d 63940-540 HUMAN OTC DRUG FACE VALUES BACITRACIN BACITRACIN OINTMENT TOPICAL 20120401 OTC MONOGRAPH FINAL part333B HARMON STORES INC. BACITRACIN 500 [USP'U]/g N 20181231 63940-541_317a9031-6060-4ae9-acbe-b51e2a544274 63940-541 HUMAN OTC DRUG FACE VALUES HYDROCORTISONE WITH ALOE HYDROCORTISONE CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part348 HARMON STORES HYDROCORTISONE 1 g/100g N 20181231 63940-542_e9535995-a73c-4c33-aae6-a700619885bd 63940-542 HUMAN OTC DRUG FACE VALUES TRIPLE ANTIBIOTIC BACITRACIN, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE OINTMENT TOPICAL 20120401 OTC MONOGRAPH FINAL part333B HARMON STORES INC. BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 63940-575_4ed36f7b-342c-494f-a48a-0bbe63c20cef 63940-575 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20160304 OTC MONOGRAPH NOT FINAL part333A Harmon Stores, Inc BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 63940-582_cd3fdff9-95a1-4769-9532-4deaced23529 63940-582 HUMAN OTC DRUG Core Values Minoxidil Minoxidil SOLUTION TOPICAL 20170517 ANDA ANDA075598 Harmon Stores Inc. MINOXIDIL 3 g/60mL N 20181231 63940-590_18d61e4b-c542-4e22-a3ac-fa465b0eaeeb 63940-590 HUMAN OTC DRUG harmon face values pain and fever acetaminophen SUSPENSION ORAL 20120417 OTC MONOGRAPH NOT FINAL part343 Harmon Stores Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 63940-600_6106a32b-7f23-1ac9-e053-2a91aa0ac85c 63940-600 HUMAN OTC DRUG Instant Hand Sanitizer Convenience Pack ALCOHOL KIT 20150105 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc N 20181231 63940-601_6106a32b-7f32-1ac9-e053-2a91aa0ac85c 63940-601 HUMAN OTC DRUG Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc ALCOHOL 620 mg/mL N 20181231 63940-602_0ef147d1-6cf8-4cfe-991b-40ecd081cf9b 63940-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20160711 OTC MONOGRAPH NOT FINAL part334 Liberty Procurement, Inc MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 63940-609_d90ea082-e440-4029-8d5f-7d596ab3b58e 63940-609 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 Harmon Store Inc. ASPIRIN 81 mg/1 N 20181231 63940-610_5b495112-72b7-4a21-9b0c-b4a60b5c56c1 63940-610 HUMAN OTC DRUG Harmon Face Values Pomegranate Scent Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130823 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc. ALCOHOL 62 mL/100mL N 20181231 63940-611_45a36bc3-cd8a-4d98-983a-36d8d459f7d6 63940-611 HUMAN OTC DRUG Harmon Face Values Cucumber Melon Scent Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130823 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc. ALCOHOL 62 mL/100mL N 20181231 63940-612_4883427a-4a60-1900-e054-00144ff8d46c 63940-612 HUMAN OTC DRUG Harmon Face Values Fresh Waters Scent Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130823 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc. ALCOHOL 62 mL/100mL N 20181231 63940-613_7455a890-aa60-4b86-ada3-4d8fe918b78a 63940-613 HUMAN OTC DRUG Harmon Face Values Warm Vanilla Sugar Scent Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130823 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc. ALCOHOL 62 mL/100mL N 20181231 63940-614_680543ae-6a81-47c6-863d-c021702a2abc 63940-614 HUMAN OTC DRUG Harmon Face Values Cherry Blossom Scent Hand Sanitizer ALCOHOL LIQUID TOPICAL 20130823 OTC MONOGRAPH NOT FINAL part333A Harmon Stores Inc. ALCOHOL 62 mL/100mL N 20181231 63940-619_3c5d6704-493a-464d-b308-90e4ecb97620 63940-619 HUMAN OTC DRUG Harmon Core Values Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20161114 OTC MONOGRAPH NOT FINAL part343 Harmon Stores Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 63940-627_bac997e1-1bc8-4ed3-9c40-928349d9f22d 63940-627 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20130701 OTC MONOGRAPH FINAL part338 Harmon Store Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63940-628_9d3e9afa-64c9-4997-8d5b-25ca55182af2 63940-628 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part333A Liberty Procurement, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63940-630_e0d2c6b5-3c96-474b-a892-cb640d100aae 63940-630 HUMAN OTC DRUG Motion Sickness Relief DIMENHYDRINATE TABLET ORAL 20150331 OTC MONOGRAPH FINAL part336 Harmon Stores DIMENHYDRINATE 50 mg/1 N 20181231 63940-641_80971605-f6ae-4b3d-9472-58f58cc63f92 63940-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part333A Harmon Stores, Inc BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 63940-657_5b638d8a-1bc1-4b0f-943c-f210ada4b7a9 63940-657 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH NOT FINAL part334 Harmon Store Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 63940-658_a15fa627-b340-4907-983f-75b2d58b9001 63940-658 HUMAN OTC DRUG Allergy Relief Dye-Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Harmon Store Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63940-664_20419a95-0c05-41af-827a-e7c9fdce60b2 63940-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19930521 OTC MONOGRAPH NOT FINAL part356 Liberty Procurement, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63940-669_6ba8548d-9d97-43c6-83d6-adfa7ac9bbd1 63940-669 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part332 Harmon Store Inc. DIMETHICONE 125 mg/1 N 20181231 63940-676_caa55c78-e9a0-4031-9211-124822445f10 63940-676 HUMAN OTC DRUG Gentle Laxative womens Bisacodyl TABLET, COATED ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 Harmon Store Inc. BISACODYL 5 mg/1 N 20181231 63940-688_84c99be9-5743-494c-86c4-4a3f4091d045 63940-688 HUMAN OTC DRUG Harmon Face Values Revitalizing Age Control Anti-Sagging Ultra Hydrating Day SPF 15 Ensulizole and Octinoxate CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Harmon Stores Inc. ENSULIZOLE; OCTINOXATE 1.7; 7.5 g/100g; g/100g N 20181231 63940-762_6b9592f2-983d-462f-90a2-c288bc8f6657 63940-762 HUMAN OTC DRUG Polyethylene Glycol Polyethylene Glycol POWDER, FOR SOLUTION ORAL 20160824 ANDA ANDA203928 Harmon Stores, Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 63940-798_9394f9a3-535f-4cca-9c20-f41af7a4db80 63940-798 HUMAN OTC DRUG harmon face values minoxidil Minoxidil SOLUTION TOPICAL 20111218 ANDA ANDA075598 Harmon Stores Inc. MINOXIDIL 3 g/60mL N 20181231 63940-802_85d20f19-0ac1-4d2d-843f-87c695877f05 63940-802 HUMAN OTC DRUG HARMON FACE VALUES MEDICATED WIPES WITCH HAZEL CLOTH TOPICAL 20120731 OTC MONOGRAPH FINAL part346 HARMON STORES INC. WITCH HAZEL 5 g/1 N 20181231 63940-803_6a650e0c-1d83-4594-9eed-d8ae48365c22 63940-803 HUMAN OTC DRUG Harmon Face Values Medicated Witch Hazel SOLUTION RECTAL; TOPICAL 20130823 OTC MONOGRAPH FINAL part346 Harmon Stores Inc. WITCH HAZEL .5 mg/mg N 20181231 63940-810_a69ea1bd-9229-44d8-965e-6c0593fcaa6e 63940-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20090518 OTC MONOGRAPH NOT FINAL part333A Liberty Procurement, Inc ISOPROPYL ALCOHOL 500 mg/mL N 20181231 63940-822_64f35844-44ca-478c-add5-d7826d40f634 63940-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20110408 OTC MONOGRAPH FINAL part347 Liberty Procurement, Inc WITCH HAZEL 841 mg/mL N 20181231 63940-845_ee15f114-9702-4376-a8fb-dd95d8bb7987 63940-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20110428 OTC MONOGRAPH FINAL part344 Liberty Procurement, Inc ISOPROPYL ALCOHOL 613 mg/mL N 20181231 63940-855_95eb1258-b31f-4086-8771-4092cb5b460e 63940-855 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20170209 OTC MONOGRAPH NOT FINAL part356 Liberty Procurement, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63940-871_6e65843b-9bd1-4b35-8193-b643a402b44f 63940-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20090612 OTC MONOGRAPH NOT FINAL part333A Liberty Procurement, Inc. HYDROGEN PEROXIDE 30 mg/mL N 20181231 63940-876_9b7618ae-536b-4d56-aa63-a3f4d3bf4673 63940-876 HUMAN OTC DRUG Ethyl Rubbing Alcohol Ethyl Alcohol LIQUID TOPICAL 20110420 OTC MONOGRAPH NOT FINAL part333A Liberty Procurement, Inc ALCOHOL 610 mg/mL N 20181231 63940-897_6c6bc564-8ae4-41de-8ee3-abc7715cdb75 63940-897 HUMAN OTC DRUG harmon face values ibuprofen Ibuprofen SUSPENSION ORAL 20111218 ANDA ANDA074937 Harmon Stores Inc. IBUPROFEN 100 mg/5mL N 20181231 63940-904_bdd7d061-0d8a-4304-a1a6-98d92fa05430 63940-904 HUMAN OTC DRUG Core Values Allergy Relief Loratadine TABLET ORAL 20111218 ANDA ANDA076301 Harmon Stores Inc. LORATADINE 10 mg/1 N 20191231 63940-915_ddd867cb-71df-4b1b-84a7-415e67076d5f 63940-915 HUMAN OTC DRUG harmon face values omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20111218 NDA NDA022032 Harmon Stores Inc. OMEPRAZOLE 20 mg/1 N 20181231 63940-927_232e0c22-8df5-40be-8d35-a94985196cd9 63940-927 HUMAN OTC DRUG buybuyBABY maximum strength diaper rash skin protectant ZINC OXIDE PASTE TOPICAL 20161207 OTC MONOGRAPH FINAL part347 Harmon Stores Inc. ZINC OXIDE 45.2 g/113g N 20181231 63940-952_095c821e-3914-4e5f-8dcd-cd6a681e02a5 63940-952 HUMAN OTC DRUG Clear Anti-Itch Pramoxine HCl, Zinc acetate LOTION TOPICAL 20110317 OTC MONOGRAPH NOT FINAL part347 Liberty Procurement, Inc PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 1; .1 mg/mL; mg/mL N 20181231 63940-975_c666fe65-48ec-4784-b474-725e7d6a64af 63940-975 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET, FILM COATED ORAL 19930402 OTC MONOGRAPH NOT FINAL part343 Harmon Store Inc. ACETAMINOPHEN 500 mg/1 N 20181231 63941-001_fdff1bbd-4d1b-4471-b5f4-db3297958b56 63941-001 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19950609 OTC MONOGRAPH NOT FINAL part356 Valu Merchandisers Co. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63941-002_843d077e-993f-4268-8ddc-31fe44594427 63941-002 HUMAN OTC DRUG Stool Softener plus Stimulant Laxative Docusate sodium and Sennosides TABLET ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 63941-003_dc4c0d9f-39bc-4d60-9066-c8a3c559aadc 63941-003 HUMAN OTC DRUG Antiseptic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19950609 OTC MONOGRAPH NOT FINAL part356 Valu Merchandisers Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63941-005_2bcfbd70-ae23-46a2-a9d8-e5d870c18872 63941-005 HUMAN OTC DRUG Aloe Vera Gel Lidocaine HCl GEL TOPICAL 20170814 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers, CO. LIDOCAINE HYDROCHLORIDE 2.5 g/g N 20181231 63941-007_bc483f41-2d34-4075-8144-b9490beeffd4 63941-007 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20090116 OTC MONOGRAPH NOT FINAL part333A Best Choice (Valu Merchandisers Company) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 63941-008_6ab47cfe-f8d7-4a78-9ae0-5b8fa7b7fb3e 63941-008 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20141016 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers Co. ALCOHOL 70 mL/100mL N 20181231 63941-012_ff076f39-74e9-4035-828b-e73db5aa803d 63941-012 HUMAN OTC DRUG Childrens Cold and Allergy Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/10mL; mg/10mL N 20181231 63941-013_9d58cbe2-f3f0-418e-92db-1e9091f56cb7 63941-013 HUMAN OTC DRUG Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20150930 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 63941-026_fb442c1f-b7f2-45f2-9033-3c7498aae986 63941-026 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 63941-035_4998d1a6-a435-4ab4-8b14-2377ca9160c2 63941-035 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100625 ANDA ANDA090283 Valu Merchandisers Company FAMOTIDINE 10 mg/1 N 20181231 63941-036_4998d1a6-a435-4ab4-8b14-2377ca9160c2 63941-036 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20100723 ANDA ANDA090283 Valu Merchandisers Company FAMOTIDINE 20 mg/1 N 20181231 63941-037_5d926755-d980-1ecf-e053-2991aa0a032b 63941-037 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20171109 OTC MONOGRAPH FINAL part341 Valu Merchandisers MENTHOL 5.8 mg/1 N 20181231 63941-038_5d932670-f679-073e-e053-2991aa0ae091 63941-038 HUMAN OTC DRUG Sugar Free Cherry Cough Drops Menthol LOZENGE ORAL 20171109 OTC MONOGRAPH FINAL part341 Valu Merchandisers MENTHOL 5.8 1/1 N 20181231 63941-039_5d941233-ae36-7406-e053-2a91aa0aaeab 63941-039 HUMAN OTC DRUG Sugar Free Honey Lemon Cough Drops Menthol LOZENGE ORAL 20171109 OTC MONOGRAPH FINAL part341 Valu Merchandisers MENTHOL 7.6 mg/1 N 20181231 63941-040_4809b267-b0d3-4588-e054-00144ff88e88 63941-040 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20130731 OTC MONOGRAPH FINAL part341 Valu Merchandisers Co. MENTHOL 5.4 mg/1 N 20181231 63941-041_481f8cd9-878f-017f-e054-00144ff8d46c 63941-041 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20130731 OTC MONOGRAPH FINAL part341 Valu Merchandisers Co. MENTHOL 5.8 mg/1 N 20181231 63941-042_48697cc4-f107-2e1e-e054-00144ff8d46c 63941-042 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20130731 OTC MONOGRAPH FINAL part341 Valu Merchandisers Co. MENTHOL 7.5 mg/1 N 20181231 63941-043_486a949d-f8bd-51e9-e054-00144ff8d46c 63941-043 HUMAN OTC DRUG SF Menthol Cough Drops Menthol LOZENGE ORAL 20130731 OTC MONOGRAPH FINAL part341 Valu Merchandisers Co. MENTHOL 5.8 mg/1 N 20181231 63941-044_486b394d-71a2-0796-e054-00144ff88e88 63941-044 HUMAN OTC DRUG SF Cherry Cough Drop Menthol LOZENGE ORAL 20150309 OTC MONOGRAPH FINAL part341 Valu Merchandisers Co. MENTHOL 5.8 mg/1 N 20181231 63941-045_486b7868-0ced-305e-e054-00144ff8d46c 63941-045 HUMAN OTC DRUG SF Honey Lemon Cough Drop Menthol LOZENGE ORAL 20130731 OTC MONOGRAPH FINAL part341 Valu Merchandisers Co. MENTHOL 7.6 mg/1 N 20181231 63941-046_480a0a5e-39ef-1f2e-e054-00144ff88e88 63941-046 HUMAN OTC DRUG Herbal Cough Drops Menthol LOZENGE ORAL 20141001 OTC MONOGRAPH FINAL part341 Valu Merchandisers Co. MENTHOL 4.8 mg/1 N 20181231 63941-047_4ac63cf7-f063-30a1-e054-00144ff88e88 63941-047 HUMAN OTC DRUG Cherry Sore Throat Relief Lozenge Benzocaine LOZENGE ORAL 20130828 OTC MONOGRAPH NOT FINAL part356 Valu Merchandisers Company BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 63941-048_5d900aa5-0a36-3faa-e053-2a91aa0a6481 63941-048 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20171109 OTC MONOGRAPH FINAL part341 Valu Merchandisers MENTHOL 5.4 mg/1 N 20181231 63941-049_5d90f70b-9ebb-1429-e053-2a91aa0a7165 63941-049 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20171109 OTC MONOGRAPH FINAL part341 Valu Merchandisers MENTHOL 5.8 mg/1 N 20181231 63941-050_5d91a05f-dbcf-5ce4-e053-2a91aa0a2706 63941-050 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20171109 OTC MONOGRAPH FINAL part341 Valu Merchandisers MENTHOL 7.5 mg/1 N 20181231 63941-052_20a4fa3a-cb15-46e4-bfc3-3b779460918e 63941-052 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET ORAL 20140430 OTC MONOGRAPH FINAL part338 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63941-053_00c0b9aa-94d9-40c0-bde4-1cda4b12afb5 63941-053 HUMAN OTC DRUG Severe Multi-Symptom Cold Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guiafenesin TABLET, COATED ORAL 20050804 20180916 OTC MONOGRAPH NOT FINAL part343 VALUE MERCHANDISERS COMPANY, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 63941-055_9e8e861a-39f0-4acc-80cc-ea8a4b13cb40 63941-055 HUMAN OTC DRUG Best Choice Fresh Scent Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers Company BENZALKONIUM CHLORIDE .115 g/1 N 20181231 63941-079_f28d773e-049b-4ad3-8c4f-14953f525d50 63941-079 HUMAN OTC DRUG Night Time Cold and Cough Childrens Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20141031 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 63941-085_c74fb125-77f4-4792-825b-1271d4106349 63941-085 HUMAN OTC DRUG Best Choice Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Valu Merchandisers Company LORATADINE 5 mg/5mL N 20181231 63941-088_f9f7365a-dbbd-4409-b9dd-c798bc3d5e00 63941-088 HUMAN OTC DRUG Best Choice Childrens Cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Valu Merchandisers Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 63941-092_a5314bac-570f-40b2-a1e6-520820f72781 63941-092 HUMAN OTC DRUG Best Choice Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Valu Merchandisers Company LORATADINE 5 mg/5mL N 20181231 63941-102_f14182ec-2079-475e-a9a7-cfe8879afbfe 63941-102 HUMAN OTC DRUG Best Choice Childrens Cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Valu Merchandisers Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 63941-103_46602793-0983-4e48-8212-d14289ba9844 63941-103 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20140630 OTC MONOGRAPH NOT FINAL part343 Best Choice (Valu Merchandisers Company) ASPIRIN 81 mg/1 N 20181231 63941-120_21740fb9-185a-4817-b76c-2b82eaa203ca 63941-120 HUMAN OTC DRUG womans laxative Bisacodyl TABLET ORAL 20100716 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) BISACODYL 5 mg/1 N 20181231 63941-121_6e5c4830-06ba-47d5-b5f4-f13ffee4d404 63941-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120619 ANDA ANDA202300 Valu Merchandisers Company (Best Choice) IBUPROFEN 200 mg/1 N 20181231 63941-123_54a246e3-9852-49d8-a07b-1b70b30d973f 63941-123 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 Valu Merchandisers Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 63941-125_0cb3a36a-aa1e-4664-b038-b7a1ffc0ac08 63941-125 HUMAN OTC DRUG Infants Ibuprofen Ibuprofen SUSPENSION ORAL 20091002 ANDA ANDA079058 Valu Merchandisers Company IBUPROFEN 50 mg/1.25mL N 20181231 63941-131_476994be-00fa-4b6a-9542-26fac250e2d2 63941-131 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Valu Merchandisers Company LORATADINE 5 mg/5mL N 20181231 63941-140_28396a17-655d-46e9-8927-c48ead56f95d 63941-140 HUMAN OTC DRUG Laxative Pills maximum strength Sennosides TABLET ORAL 20100823 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) SENNOSIDES 25 mg/1 N 20181231 63941-146_bff85ea7-7534-4b74-bc6e-91cdd7fcf059 63941-146 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE ORAL 20100824 OTC MONOGRAPH NOT FINAL part334 Valu Merchandisers Company (Best Choice) DOCUSATE SODIUM 100 mg/1 N 20181231 63941-153_f81fb8b1-21e6-40a9-90f5-7ca8bbb98c9c 63941-153 HUMAN OTC DRUG Everyday Clean Dandruff pyrithione zinc SHAMPOO TOPICAL 19990314 OTC MONOGRAPH FINAL part358H ValueMerchandisers PYRITHIONE ZINC 10 mg/mL N 20181231 63941-157_5ff902e5-f517-4d2c-a4af-dccc0d22ae31 63941-157 HUMAN OTC DRUG Aspirin NSAID Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 Valu Merchandisers Company ASPIRIN 325 mg/1 N 20181231 63941-159_bec876ab-bf52-4dff-9c52-d5d12010db1b 63941-159 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Valu Merchandisers Company ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 63941-161_8c039393-ca0e-4d72-8ca5-fb77ba7ae671 63941-161 HUMAN OTC DRUG Hemorrhoidal MINERAL OIL,PETROLATUM,PHENYLEPHRINE OINTMENT TOPICAL 20120206 OTC MONOGRAPH FINAL part346 Valu Merchandisers, Co. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 71.9; .25 g/100g; g/100g; g/100g E 20171231 63941-165_603bb78c-24cb-446d-80e9-30249f707381 63941-165 HUMAN OTC DRUG Sore Throat Menthol Phenol LIQUID ORAL 20090801 OTC MONOGRAPH NOT FINAL part356 Best Choice (Valu Merchandisers Company) PHENOL 1.5 g/100mL N 20181231 63941-166_6a81a801-fc5d-4b10-b52a-b8a3e0ad496c 63941-166 HUMAN OTC DRUG Ibuprofen PM Ibuprofen and Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20110610 ANDA ANDA090397 Valu Merchandisers Company (Best Choice) IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE 200; 25 mg/1; mg/1 E 20171231 63941-180_c62f99d0-4a12-452f-9656-5398c028f0fb 63941-180 HUMAN OTC DRUG Best Choice Senna Sennosides TABLET ORAL 20120518 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) SENNOSIDES A AND B 8.6 mg/1 N 20181231 63941-183_3bfd958c-f75a-4ca4-9763-9e0bd0e450fd 63941-183 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20120520 OTC MONOGRAPH NOT FINAL part343 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 63941-189_53a34719-467b-4244-996f-7fdf3eb7ac78 63941-189 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET ORAL 20120604 ANDA ANDA079112 Valu Merchandisers Company (Best Choice) FEXOFENADINE HYDROCHLORIDE 180 mg/1 E 20171231 63941-190_77e06924-afaa-4b7f-a4b2-c14d1250e981 63941-190 HUMAN OTC DRUG Best Choice Bisacodyl Laxative BISACODYL TABLET, COATED ORAL 20121102 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) BISACODYL 5 mg/1 N 20181231 63941-199_8d57097d-add8-4c0e-af9a-adccaacf4d8f 63941-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20100821 ANDA ANDA078682 Best Choice (Valu Merchandisers Company) IBUPROFEN 200 mg/1 E 20171231 63941-200_c22bf07a-91b2-4f43-8a18-e25ac88899d5 63941-200 HUMAN OTC DRUG Sleep original formula Diphenhydramine HCl TABLET ORAL 20100716 OTC MONOGRAPH FINAL part336 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63941-201_56ff4b98-b53e-39cb-e054-00144ff8d46c 63941-201 HUMAN OTC DRUG Hemorrhoidal petrolatum, mineral oil, phenylephrine HCl OINTMENT TOPICAL 20120206 OTC MONOGRAPH FINAL part346 Valu Merchandisers, Co. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 71.9; .25 g/100g; g/100g; g/100g N 20181231 63941-203_e0650e90-b680-4d8a-8598-76d9fd9478fd 63941-203 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20110711 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, CO ALCOHOL 578 mg/mL N 20181231 63941-227_e9c0ff1f-7788-44ca-8880-40196904b1d2 63941-227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET ORAL 20130308 OTC MONOGRAPH NOT FINAL part343 Best Choice (Valu Merchandisers Company) ASPIRIN 81 mg/1 N 20181231 63941-229_46f11a74-eb8b-4ef8-e054-00144ff8d46c 63941-229 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers, Co. HYDROCORTISONE 10 mg/g N 20181231 63941-230_8e96e588-8268-4ceb-b2f1-02d208cfedaf 63941-230 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl CAPSULE ORAL 20100726 OTC MONOGRAPH FINAL part341 Valu Merchandisers Company (Best Choice) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 63941-231_ee4aaaee-a613-4e4d-8f37-316ed01af351 63941-231 HUMAN OTC DRUG PAIN RELIEVER PM Extra Strength Acetaminophen, Diphenhydramine HCl CAPSULE, GELATIN COATED ORAL 20130308 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 63941-236_1a537768-b69b-4381-a0b7-07d1074161ff 63941-236 HUMAN OTC DRUG Nighttime sleep aid DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part338 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 63941-238_3a479705-3e95-4749-95fc-bd569a1b65a6 63941-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) DOCUSATE SODIUM 100 mg/1 N 20181231 63941-242_6460f7b6-d951-480a-80f6-d5dff69c14b7 63941-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20140331 OTC MONOGRAPH FINAL part347 Best Choice (Valu Merchandisers Company) DIMETHICONE 125 mg/1 N 20181231 63941-248_08d5b124-bf3d-4f62-b875-1433efef416f 63941-248 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol CREAM TOPICAL 20090112 OTC MONOGRAPH FINAL part341 Valu Merchandisers, co CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100g; kg/100g; kg/100g N 20181231 63941-249_658f3d35-cd2c-4b29-9c81-9db681f15403 63941-249 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH FINAL part343 Valu Merchandisers Company ASPIRIN 325 mg/1 N 20181231 63941-251_a741fad1-5863-4a41-8a98-9d10f7778b23 63941-251 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 20140430 OTC MONOGRAPH FINAL part340 Best Choice (Valu Merchandisers Company) CAFFEINE 200 mg/1 N 20181231 63941-252_dd5bb740-02fb-46db-bda2-2127b9e6566a 63941-252 HUMAN OTC DRUG Stay Awake Maximum strength Caffeine TABLET ORAL 20100921 OTC MONOGRAPH FINAL part340 Valu Merchandisers Company (Best Choice) CAFFEINE 200 mg/1 N 20181231 63941-253_488061ad-1a60-57d3-e054-00144ff88e88 63941-253 HUMAN OTC DRUG Best Choice Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20101028 OTC MONOGRAPH FINAL part358G Valu Merchandisers, CO. PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 63941-255_ef2b24d3-457f-4633-8975-407bccb49b8d 63941-255 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20061009 ANDA ANDA074916 Valu Merchandisers Company IBUPROFEN 100 mg/5mL N 20181231 63941-261_3ae66040-356f-4635-a06b-d71fb83d9f90 63941-261 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20120523 ANDA ANDA074916 Valu Merchandisers Company IBUPROFEN 100 mg/5mL N 20181231 63941-262_3ae66040-356f-4635-a06b-d71fb83d9f90 63941-262 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080116 20190630 ANDA ANDA074916 Valu Merchandisers Company IBUPROFEN 100 mg/5mL N 20181231 63941-276_a206561c-a53d-4a00-be8c-c2054af87335 63941-276 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 Percent Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20140930 OTC MONOGRAPH NOT FINAL part333A Best Choice (Valu Merchandisers Company) ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 63941-277_01545e5f-2a4b-433b-8420-c1629b74d332 63941-277 HUMAN OTC DRUG Rubbing Alcohol 91 percent Isopropyl Isopropyl alcohol LIQUID TOPICAL 20141031 OTC MONOGRAPH NOT FINAL part333A Best Choice (Valu Merchandisers Company) ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 63941-279_3d9707ae-64d3-47a5-8dcf-7ca0fe0acc1c 63941-279 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20160202 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, CO BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 63941-282_6c0540c4-8bf8-4295-ba9f-30f36796ce9b 63941-282 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20151031 OTC MONOGRAPH NOT FINAL part343 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN 160 mg/5mL N 20181231 63941-288_ebca916c-5679-4e60-8501-34a35e217826 63941-288 HUMAN OTC DRUG Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20150228 OTC MONOGRAPH NOT FINAL part343 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN 160 mg/5mL N 20181231 63941-292_7fd9e75c-ad20-4855-a236-8f22cd4e3eed 63941-292 HUMAN OTC DRUG Childrens Allergy Diphenhydramine HCl LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 63941-297_4b49c8cc-dbd4-4b5c-81e3-968e1737caea 63941-297 HUMAN OTC DRUG Childrens Plus Cough and Runny Nose Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide SUSPENSION ORAL 20150831 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 160; 1; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 63941-299_af140e3c-9a14-4b6f-b1e8-ffb7429d20bc 63941-299 HUMAN OTC DRUG ANTISEPTIC CETYLPYRIDINIUM CHLORIDE RINSE ORAL 20070731 OTC MONOGRAPH NOT FINAL part356 Valu Merchandisers.Co CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 63941-304_db48b4c5-9ec2-487a-8bfe-0750943eef3c 63941-304 HUMAN OTC DRUG Childrens Plus Multi Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride SUSPENSION ORAL 20150531 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL N 20181231 63941-305_c66ef962-70d4-4bda-bca0-12b5d09238d0 63941-305 HUMAN OTC DRUG Best Choice Clotrimazole Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Valu Merchandisers Company CLOTRIMAZOLE 10 mg/g N 20181231 63941-309_85fad321-3ec5-4431-b2a7-c7c7598cb31c 63941-309 HUMAN OTC DRUG Cough Relief Dextromethorphan HBr LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 63941-311_0cebc100-68f7-4f40-b7c3-b8a1d5b08a1e 63941-311 HUMAN OTC DRUG Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090106 OTC MONOGRAPH FINAL part358H Valu Merchandisers Co PYRITHIONE ZINC 10 mg/mL N 20181231 63941-312_46f1a10f-4653-678a-e054-00144ff8d46c 63941-312 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20120229 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers, Co. HYDROCORTISONE 10 mg/g N 20181231 63941-313_5514b428-7d32-729d-e054-00144ff8d46c 63941-313 HUMAN OTC DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers, Co. HYDROCORTISONE 10 mg/g N 20181231 63941-314_90c12c45-4c04-440f-9b35-729d1fc962b6 63941-314 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20120716 OTC MONOGRAPH FINAL part333B Valu Merchandisers, Co. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g E 20171231 63941-315_615ac2dd-69c0-3275-e053-2991aa0a544d 63941-315 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20120905 OTC MONOGRAPH FINAL part333B Valu Merchandisers, Co. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 63941-316_615ac2dd-69d4-3275-e053-2991aa0a544d 63941-316 HUMAN OTC DRUG Allergic Itch Relief Diphenhydramine HCl, Zinc acetate CREAM TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers, Co. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 63941-317_615ae6ca-d803-bdc6-e053-2a91aa0a70df 63941-317 HUMAN OTC DRUG Muscle and Joint Pain Relief MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20120130 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers, Co. MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g N 20181231 63941-318_615abc98-0942-8a74-e053-2a91aa0a32bd 63941-318 HUMAN OTC DRUG Diaper Rash Zinc Oxide CREAM TOPICAL 20120130 OTC MONOGRAPH FINAL part347 Valu Merchandisers, Co. ZINC OXIDE 400 mg/g N 20181231 63941-321_542baaeb-1219-46ce-8dc9-57a6d8a649aa 63941-321 HUMAN OTC DRUG Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20151031 OTC MONOGRAPH NOT FINAL part343 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN 160 mg/5mL N 20181231 63941-324_a3376f43-5dcc-4387-bfc4-eb169dc11477 63941-324 HUMAN OTC DRUG Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20150630 OTC MONOGRAPH NOT FINAL part343 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN 160 mg/5mL N 20181231 63941-326_3b920422-1544-43ad-85a0-d07565ecc2b2 63941-326 HUMAN OTC DRUG Tartar Control Plus eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19991025 OTC MONOGRAPH NOT FINAL part356 Valu Merchandisers, Co., EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63941-329_befe2bb3-3643-4d78-88b8-55aad4d2b535 63941-329 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20150630 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 63941-332_f5cf789a-cc9f-4958-a56f-d90e94ba8a91 63941-332 HUMAN OTC DRUG EasyLax Polyethylene Glycol POWDER TOPICAL 20160331 ANDA ANDA091077 Best Choice (Valu Merchandisers Company) POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 63941-333_6cd4146e-0104-4118-8fd8-f15557a37a49 63941-333 HUMAN OTC DRUG Acetaminophen - APAP Arthritis Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Valu Merchandisers Company ACETAMINOPHEN 650 mg/1 N 20181231 63941-334_45bc0db2-e73c-4340-a39e-03484622382a 63941-334 HUMAN OTC DRUG Mineral oil Mineral oil OIL ORAL 20161031 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) MINERAL OIL 100 mg/100mL N 20181231 63941-336_dc585b2e-10c2-4a31-8400-34cde7e11a43 63941-336 HUMAN OTC DRUG Acetaminophen - APAP 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Valu Merchandisers Company ACETAMINOPHEN 650 mg/1 N 20181231 63941-338_95ed8126-4ab4-4387-822c-2b22572eec87 63941-338 HUMAN OTC DRUG Mucus Relief DM MAX Maximum Strength Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20140630 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 63941-341_9d8258c8-133c-458b-adba-7a209e26af0b 63941-341 HUMAN OTC DRUG Daytime Sinus Acetaminophen and Phenylephrine HCI CAPSULE, LIQUID FILLED ORAL 20120529 OTC MONOGRAPH FINAL part341 VALU MERCHANDISERS COMPANY ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 E 20171231 63941-342_99c72bc0-2ac1-460e-929f-30ef642c71bd 63941-342 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20160229 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 63941-343_1e3cd2fb-df70-42e7-a2c2-a00dd8e057fe 63941-343 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20161031 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20191231 63941-344_66eceac3-2d9b-4dd3-b671-0e3f75ef8c6e 63941-344 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20161031 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 63941-345_07ea324d-60d1-46d0-a82f-5eb4fb3e9992 63941-345 HUMAN OTC DRUG Cough Relief Nighttime Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20160229 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 63941-346_e6ac9a66-7104-49f4-a9e2-14bbdabc7389 63941-346 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 63941-351_c4f63f37-715b-462a-b5fb-a7bc58461de5 63941-351 HUMAN OTC DRUG ACID REDUCER Ranitidine Hydrochloride TABLET ORAL 20120330 ANDA ANDA200536 Valu Merchandisers Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 63941-352_c369afdb-43ba-482b-a051-83c42c09a64a 63941-352 HUMAN OTC DRUG Ranitidine Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Valu Merchandisers Company RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 63941-354_615e644a-5681-4e4c-e053-2991aa0ac7a1 63941-354 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part333C Valu Merchandisers, Co. TOLNAFTATE 1 g/100g N 20181231 63941-360_32201cc5-e4e1-4d93-b48e-727179d000d8 63941-360 HUMAN OTC DRUG NON ASPIRIN PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20120910 OTC MONOGRAPH FINAL part338 Valu Merchandisers Company (Best Choice) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 63941-370_59b8ac8e-024d-4925-a732-37daeaffb772 63941-370 HUMAN OTC DRUG Enteric Coated Aspirin regular strength Aspirin TABLET, COATED ORAL 20111111 OTC MONOGRAPH FINAL part343 Best Choice (Valu Merchandisers Company) ASPIRIN 325 mg/1 N 20181231 63941-371_c8a5d71a-4922-4f50-a56b-8b1f35e28cf1 63941-371 HUMAN OTC DRUG Stomach Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part335 Best Choice (Valu Merchandisers Company) BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 63941-372_8658be40-918f-47bb-bd9d-e5bcc1b90e83 63941-372 HUMAN OTC DRUG Stomach Relief Regular Strength Bismuth subsalicylate LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part335 Best Choice (Valu Merchandisers Company) BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 63941-373_85b1de9f-f40c-4f53-b327-5f1a8a20b112 63941-373 HUMAN OTC DRUG Headache Relief PM Acetaminophen and Diphenhydramine Citrate TABLET, FILM COATED ORAL 20040607 20200220 OTC MONOGRAPH NOT FINAL part343 Valu Merchandisers Company ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 N 20181231 63941-376_9f23c421-4269-4f28-a2a5-427f3b8ac839 63941-376 HUMAN OTC DRUG Sore Throat Relief Cherry Phenol SPRAY ORAL 20140829 OTC MONOGRAPH NOT FINAL part356 Best Choice (Valu Merchandisers Company) PHENOL 1.4 g/100mL N 20181231 63941-378_20f7aa2f-eb46-4232-8571-4fb0c6275e05 63941-378 HUMAN OTC DRUG Childrens Day Time Cold and Cough Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20140731 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 2.5; 5 mg/5mL; mg/5mL N 20181231 63941-379_c02251af-8a91-4701-84e8-a4d003649073 63941-379 HUMAN OTC DRUG Childrens Night Time Cold and Cough Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20140731 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 2.5 mg/5mL; mg/5mL N 20181231 63941-382_3abe7e4c-c04e-4177-a712-4b7ec0b88b50 63941-382 HUMAN OTC DRUG Tussin Multi Symptom Cold CF Dextromethorphan HBr, Guaifenesin, Phenylephrine LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 63941-384_f904dac0-7dcd-4495-a3d2-0c6ebde4449f 63941-384 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM Sugar Free Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20160331 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/10mL; mg/10mL N 20181231 63941-385_e2e361d4-a29a-4480-9a04-aab37f6facd9 63941-385 HUMAN OTC DRUG Tussin Cough and Chest Congestion DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 63941-389_8a816864-80ca-4b91-8b59-3359a8e03d6f 63941-389 HUMAN OTC DRUG Tussin Chest Congestion Guaifenesin LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) GUAIFENESIN 200 mg/10mL N 20181231 63941-390_91227afe-e6db-4132-ab29-29ab351caa4e 63941-390 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20140829 OTC MONOGRAPH FINAL part347 Best Choice (Valu Merchandisers Company) WITCH HAZEL 842 mg/mL N 20181231 63941-397_47baa020-4c9b-4f38-8d00-2d096287603b 63941-397 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, CHEWABLE ORAL 20010904 OTC MONOGRAPH NOT FINAL part343 Valu Merchandisers Company ASPIRIN 81 mg/1 N 20181231 63941-400_5d6c51b8-47ec-c38b-e053-2991aa0a0f23 63941-400 HUMAN OTC DRUG Best Choice Anti-Itch Clear Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Valu Merchandisers, CO ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 63941-403_df0a109f-990e-4046-83bc-e0882bec701c 63941-403 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20141009 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, Co BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 63941-407_2904b24c-5b25-48a1-8bb3-9dcdaca2879c 63941-407 HUMAN OTC DRUG Best Choice Cold Sore Treatment Camphor CREAM TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part348 Best Choice BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 63941-411_4d2b062f-b682-4ba4-8870-b6b402b4e4f8 63941-411 HUMAN OTC DRUG Cold and Cough High Blood Pressure Chlorpheniramine maleate, Dextromethorphan HBr TABLET ORAL 20030503 OTC MONOGRAPH FINAL part341 Valu Merchandisers Company CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 63941-414_35bcccfe-e8d8-441c-8aa7-45dcc20a811e 63941-414 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20090203 OTC MONOGRAPH NOT FINAL part356 Best Choice (Valu Merchandisers Company) HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 63941-420_5d6c51b8-47fc-c38b-e053-2991aa0a0f23 63941-420 HUMAN OTC DRUG Best Choice Medicated Calamine Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Valu Merchandisers, CO. ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 63941-425_53d89bf8-6aab-4be4-8596-0b55f2b59d60 63941-425 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate LIQUID ORAL 20150831 OTC MONOGRAPH FINAL part335 Best Choice (Valu Merchandisers Company) BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 63941-439_e6498a16-70fd-4e41-8774-2e410d418db1 63941-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers,CO ALCOHOL 700 mg/mL N 20181231 63941-440_8244057c-8522-4871-8576-a15b9583cbb7 63941-440 HUMAN OTC DRUG Aspirin Adult low strength Aspirin TABLET, DELAYED RELEASE ORAL 20100726 OTC MONOGRAPH FINAL part343 Valu Merchandisers Company (Best Choice) ASPIRIN 81 mg/1 N 20181231 63941-441_c7e09164-cdab-4aef-a813-2c02ede6a49d 63941-441 HUMAN OTC DRUG Safety Coated Aspirin Aspirin TABLET ORAL 20100821 OTC MONOGRAPH NOT FINAL part343 Valu Merchandisers Company (Best Choice) ASPIRIN 81 mg/1 N 20181231 63941-449_dd37b091-74c5-4f94-90f3-7410a1245047 63941-449 HUMAN OTC DRUG Junior Strength Pain Reliever Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Valu Merchandisers Company ACETAMINOPHEN 160 mg/1 N 20181231 63941-452_9d369cfb-ce6a-41bb-b0ac-0f75d972db8c 63941-452 HUMAN OTC DRUG Childrens Pain Reliever Grape Flavor Acetaminophen TABLET, CHEWABLE ORAL 20041206 OTC MONOGRAPH NOT FINAL part343 Valu Merchandisers Company ACETAMINOPHEN 80 mg/1 N 20181231 63941-466_ceb972d7-b5ce-4cef-85fe-4be5de22598b 63941-466 HUMAN OTC DRUG Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20191231 63941-470_1234a8aa-35e2-4db7-bdfb-454aba366592 63941-470 HUMAN OTC DRUG Multi-Symptom Cold Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 OTC MONOGRAPH FINAL part341 Valu Merchandisers Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 63941-473_5e153ee2-cce4-4383-a5c8-bfb4d330adcc 63941-473 HUMAN OTC DRUG Multi-Symptom Cold Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050721 OTC MONOGRAPH FINAL part341 Valu Merchandisers Company ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63941-481_33081702-5dce-438b-8a6c-a5ff42b3cf7a 63941-481 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 20150930 OTC MONOGRAPH FINAL part336 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63941-484_34da6016-c8fa-4e3e-a537-a72be513da63 63941-484 HUMAN OTC DRUG Stool Softener Plus Stimulant Laxative docusate sodium and sennosides TABLET ORAL 20151231 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 63941-486_a082949a-a1bf-40c9-99f4-015fa381af58 63941-486 HUMAN OTC DRUG Senna Natural Vegetable Laxative SENNOSIDES TABLET ORAL 20151216 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) SENNOSIDES 8.6 mg/1 N 20181231 63941-487_a30dd9fa-08d4-49fc-8814-994aa632604f 63941-487 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20160229 OTC MONOGRAPH FINAL part347 Best Choice (Valu Merchandisers Company) DIMETHICONE 125 mg/1 N 20181231 63941-503_9296ab06-4b87-4e25-9518-e48228155879 63941-503 HUMAN OTC DRUG Multi-Symptom Cold Severe, Non-Drowsy, Daytime Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 Valu Merchandisers Company ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20191231 63941-504_d5bc6112-22c5-4eb6-97a6-fd34a5556317 63941-504 HUMAN OTC DRUG Allergy Relief Fexofenadine HCl TABLET ORAL 20170531 ANDA ANDA079112 Best Choice (Valu Merchandisers Company) FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 63941-519_40ef97ca-244d-41db-88da-a0af729fa1a4 63941-519 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Valu Merchandisers Company ACETAMINOPHEN 500 mg/1 N 20181231 63941-520_16f5b062-ac9f-48be-8590-51b9bb412ef8 63941-520 HUMAN OTC DRUG Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100830 NDA NDA021855 Best Choice (Valu Merchandisers Company) LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 63941-525_4e1c3b77-aa2a-4761-e054-00144ff88e88 63941-525 HUMAN OTC DRUG Hemorrhoidal Pad Witch Hazel Pad CLOTH TOPICAL 20111201 OTC MONOGRAPH FINAL part346 Valu Merchandisers, Co. WITCH HAZEL 5 g/1 N 20181231 63941-526_ee2fab3c-b65b-43a9-9da8-288bc2b0bf44 63941-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Valu Merchandisers Company LORATADINE 10 mg/1 N 20181231 63941-527_4841c445-7950-4ec0-869a-8331878a659a 63941-527 HUMAN OTC DRUG Severe Sinus Congestion and Pain Non-Drowsy, Daytime Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 Valu Merchandisers Company ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 63941-528_a070a784-fcd5-4af5-9b1d-1cc63153843a 63941-528 HUMAN OTC DRUG Loratadine Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Valu Merchandisers Company LORATADINE 10 mg/1 N 20181231 63941-530_e4f014f6-ca12-4a40-90ae-81b588d2b1d3 63941-530 HUMAN OTC DRUG Antigas Antiflatulent ultra strength Simethicone CAPSULE, LIQUID FILLED ORAL 20100713 OTC MONOGRAPH FINAL part332 Best Choice (Valu Merchandisers Company) DIMETHICONE 180 mg/1 E 20171231 63941-540_7e036e7e-8712-40f3-8f26-4a514bba0e1a 63941-540 HUMAN OTC DRUG Tolnafate Tolnaftate Jock Itch Powder Spray - Talc Free AEROSOL, SPRAY TOPICAL 20171031 OTC MONOGRAPH FINAL part333C VALU MERCHANDISERS, CO. TOLNAFTATE 1.3 g/130g N 20181231 63941-541_d2397e2c-cd09-4074-a9ba-2b8e0c9bc671 63941-541 HUMAN OTC DRUG Tolnafate Tolnaftate Athletes Foot Powder Spray Talc Free AEROSOL, SPRAY TOPICAL 20171031 OTC MONOGRAPH FINAL part333C VALU MERCHANDISERS, CO TOLNAFTATE 1.3 g/130g N 20181231 63941-542_7e6539b0-8696-49d5-b9cb-5ce5a1c4bdeb 63941-542 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20171208 OTC MONOGRAPH FINAL part358F VALU MERCHANDISERS, CO SALICYLIC ACID 40 mg/91 N 20181231 63941-543_8725c357-7a41-428f-9c41-a6c24c2e8b5e 63941-543 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20171208 OTC MONOGRAPH FINAL part358F VALU MERCHANDISERS, CO SALICYLIC ACID 40 mg/41 N 20181231 63941-544_46df9bcf-6245-4095-840f-d5055583525f 63941-544 HUMAN OTC DRUG Salicylic Acid Corn and Callus Remover Kit LIQUID TOPICAL 20171211 OTC MONOGRAPH FINAL part358F VALU MERCHANDISERS, CO SALICYLIC ACID .17 mg/9.8mL N 20181231 63941-545_d805bab9-67ee-4cc0-ab5e-7634e178c9a0 63941-545 HUMAN OTC DRUG Salicylic Acid Liquid Wart Remover LIQUID TOPICAL 20171211 OTC MONOGRAPH FINAL part358F VALU MERCHANDISERS, CO SALICYLIC ACID .17 g/9mL N 20181231 63941-546_1f983545-5102-42e5-9a75-9db3633a3979 63941-546 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20171211 OTC MONOGRAPH NOT FINAL part333A VALU MERCHANDISERS, CO BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/9mL; mg/9mL N 20181231 63941-547_adc0dc9b-bfcf-4f31-8963-27969a477f4e 63941-547 HUMAN OTC DRUG Salicylic Acid One Step Corn Remover PATCH TOPICAL 20171211 OTC MONOGRAPH FINAL part358F VALU MERCHANDISERS, CO SALICYLIC ACID 40 mg/61 N 20181231 63941-548_92c7d4f8-7c87-49f3-97ba-63c2b46664f1 63941-548 HUMAN OTC DRUG Tolnaftate Jock Itch Powder AEROSOL, SPRAY TOPICAL 20171211 OTC MONOGRAPH FINAL part333C VALU MERCHANDISERS, CO TOLNAFTATE 1.3 g/130g N 20181231 63941-549_54695df2-8b7e-4795-94ef-52f986f0a2f9 63941-549 HUMAN OTC DRUG Diphenhydramine HCl and Zinc Acetate Extra Strength Itch Relief SPRAY TOPICAL 20171211 OTC MONOGRAPH NOT FINAL part348 VALU MERCHANDISERS, CO DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.52; .076 g/88mL; g/88mL N 20181231 63941-550_2b7957c5-69d4-42e7-9f6f-b4e8d8ece5dc 63941-550 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100713 OTC MONOGRAPH FINAL part332 Valu Merchandisers Company (Best Choice) DIMETHICONE 125 mg/1 E 20171231 63941-551_c5fa7e78-f27f-4eac-94b6-170972d879d6 63941-551 HUMAN OTC DRUG Salicylic acid Medicated Callus Removers Extra Thick PATCH TOPICAL 20140101 OTC MONOGRAPH FINAL part358F VALU MERCHANDISERS, CO SALICYLIC ACID 40 mg/41 N 20181231 63941-552_c875c8ee-4c67-4052-b4ac-a68960c0ef68 63941-552 HUMAN OTC DRUG Menthol Maximum Strength Medicated Foot Powder POWDER TOPICAL 20171212 OTC MONOGRAPH NOT FINAL part348 VALU MERCHANDISERS, CO MENTHOL 2.8 g/283g N 20181231 63941-553_f4c18432-62e6-4330-a1a8-2fde319dd30a 63941-553 HUMAN OTC DRUG Salicylic Acid Wart Remover Gel Tube GEL TOPICAL 20171212 OTC MONOGRAPH FINAL part358B VALU MERCHANDISERS, CO SALICYLIC ACID .17 g/7g N 20181231 63941-554_c9327a48-96a4-4e70-868c-f927bd165f51 63941-554 HUMAN OTC DRUG Tolnaftate Athletes Foot Liquid SPRAY TOPICAL 20171212 OTC MONOGRAPH FINAL part333C VALU MERCHANDISERS, CO TOLNAFTATE 1.5 g/150g N 20181231 63941-555_8a29f0b4-28cd-4815-b81f-15ee9bb6d623 63941-555 HUMAN OTC DRUG Tolnaftate Tolnaftate Athletes Foot Powder Spray SPRAY TOPICAL 20171212 OTC MONOGRAPH FINAL part333C VALU MERCHANDISERS, CO TOLNAFTATE 1.3 g/130g N 20181231 63941-556_0f4c9dd2-94d1-426d-b478-5043685df686 63941-556 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 Valu Merchandisers Company ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 63941-557_760fc929-80b1-4a3a-bdd8-b7b92dc39d64 63941-557 HUMAN OTC DRUG Tolnafate Foot Odor Control Powder Spray AEROSOL, SPRAY TOPICAL 20171212 OTC MONOGRAPH FINAL part333C VALU MERCHANDISERS, CO TOLNAFTATE 1.3 g/113g N 20181231 63941-578_f1401d12-d0a7-4cb3-8e19-8c867a3a1fe7 63941-578 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170831 OTC MONOGRAPH NOT FINAL part334 Best Choice (Valu Merchandisers Company) DOCUSATE SODIUM 100 mg/1 N 20181231 63941-602_7339f031-d8c5-4008-845d-8c79f3379b92 63941-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part334 Valu Merchandisers, Co. MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 63941-616_56fd134d-9993-6770-e054-00144ff88e88 63941-616 HUMAN OTC DRUG Best Choice Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20120724 OTC MONOGRAPH FINAL part333B Valu Merchandisers, Co. BACITRACIN ZINC 500 [USP'U]/g N 20181231 63941-619_5e81196f-7d21-1a6b-e053-2a91aa0a4dbb 63941-619 HUMAN OTC DRUG MAXIMUM STRENGTH ANTACID AND ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20170801 OTC MONOGRAPH FINAL part331 VALU MERCHANDISERS COMPANY ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 63941-624_5e94798a-7b79-7728-e053-2a91aa0a4510 63941-624 HUMAN OTC DRUG SUPREME ANTACID calcium carbonate, magnesium hydroxide SUSPENSION ORAL 20170801 OTC MONOGRAPH FINAL part331 VALU MERCHANDISERS COMPANY CALCIUM CARBONATE; MAGNESIUM HYDROXIDE 400; 135 mg/5mL; mg/5mL N 20181231 63941-626_9d99b3a1-fc20-436f-94ef-a4edb81b14ab 63941-626 HUMAN OTC DRUG Best Choice absolute Daily Moisturizing Broad Spectrum SPF 15 Sunscreen Avobenzone, Homosalate, Octinoxate, Octocrylene CREAM TOPICAL 20121215 OTC MONOGRAPH NOT FINAL part352 Valu Merchandisers Company AVOBENZONE; OCTOCRYLENE; HOMOSALATE; OCTINOXATE 20; 26; 30; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63941-629_5e82a4f4-c7db-09cb-e053-2a91aa0abf5b 63941-629 HUMAN OTC DRUG REGULAR STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20170701 OTC MONOGRAPH FINAL part331 VALU MERCHANDISERS COMPANY ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 63941-630_922e6a78-c892-4413-8153-9dee78be16c8 63941-630 HUMAN OTC DRUG Travel Ease Dimenhydrinate TABLET ORAL 20100810 OTC MONOGRAPH FINAL part336 Best Choice (Valu Merchandisers Company) DIMENHYDRINATE 50 mg/1 N 20181231 63941-638_5e94cb90-b617-dcfe-e053-2a91aa0ada72 63941-638 HUMAN OTC DRUG MAXIMUM STRENGTH ANTACID AND ANTIGAS CHERRY aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20170801 OTC MONOGRAPH FINAL part331 VALU MERCHANDISERS COMPANY ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 63941-639_5e8215a4-0137-bfdd-e053-2991aa0a5ddf 63941-639 HUMAN OTC DRUG REGULAR STRENGTH ANTACID ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20170801 OTC MONOGRAPH FINAL part331 VALU MERCHANDISERS COMPANY ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 63941-647_5e993b13-8dc9-6653-e053-2a91aa0a4c2a 63941-647 HUMAN OTC DRUG MILK OF MAGNESIA magnesium hydroxide SUSPENSION ORAL 20170701 OTC MONOGRAPH NOT FINAL part334 VALU MERCHANDISERS COMPANY MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 63941-648_5e98f9e6-714d-63a4-e053-2991aa0a8cb7 63941-648 HUMAN OTC DRUG MILK OF MAGNESIA magnesium hydroxide SUSPENSION ORAL 20170701 OTC MONOGRAPH NOT FINAL part334 VALU MERCHANDISERS COMPANY MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 63941-649_5e957b01-4f45-0a2a-e053-2991aa0a37a0 63941-649 HUMAN OTC DRUG MILK OF MAGNESIA magnesium hydroxide SUSPENSION ORAL 20170701 OTC MONOGRAPH NOT FINAL part334 VALU MERCHANDISERS COMPANY MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 63941-664_a8fc58bf-1168-4d36-9c99-2d6401216a7a 63941-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19980315 OTC MONOGRAPH NOT FINAL part356 Valu Merchandisers, Co EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63941-670_638cf69a-ac98-465b-9f99-25438731e01e 63941-670 HUMAN OTC DRUG Nasal Decongestant PE Phenylephrine Hydrochloride TABLET ORAL 20100830 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 63941-674_ea8d11d8-bc60-43c2-834d-406ecbb68e2e 63941-674 HUMAN OTC DRUG Headache Relief PM Acetaminophen, Aspirin, Diphenhydramine citrate TABLET, FILM COATED ORAL 20160831 OTC MONOGRAPH NOT FINAL part343 Valu Merchandisers Company ACETAMINOPHEN; ASPIRIN; DIPHENHYDRAMINE CITRATE 250; 250; 38 mg/1; mg/1; mg/1 N 20181231 63941-689_1c65b92b-b271-45a7-b3f1-41a3a35d04da 63941-689 HUMAN OTC DRUG Cold and Cough Chlorpheniramine maleate, Dextromethorphan HBr TABLET, COATED ORAL 20170331 OTC MONOGRAPH FINAL part341 Valu Merchandisers Company CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 63941-690_473c6352-4209-4789-aab9-42507b80d13c 63941-690 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20100827 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63941-693_385a2ea6-5c85-4230-b4a6-7b7db5529ceb 63941-693 HUMAN OTC DRUG Best Choice Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20120724 OTC MONOGRAPH FINAL part333B Valu Merchandisers, Co. BACITRACIN ZINC 500 [USP'U]/g E 20171231 63941-727_4b6a9552-21b5-4b48-9560-8a3370bf6ce5 63941-727 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20171121 OTC MONOGRAPH FINAL part352 Valu Merchandisers AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 26.49; 132.45; 44.15; 52.98 mg/g; mg/g; mg/g; mg/g N 20191231 63941-730_fc8cc378-d74e-4985-931a-e41a67e9ca1a 63941-730 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Oxybenzone SPRAY TOPICAL 20171213 OTC MONOGRAPH FINAL part352 Valu Merchandiser, Co AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 20; 150; 50; 40 mg/g; mg/g; mg/g; mg/g N 20191231 63941-775_93a0cf6a-70cc-4e14-9531-6038ccb2f905 63941-775 HUMAN OTC DRUG Best Choice Oil-Free Acne Wash Foaming Scrub Salicylic Acid LOTION TOPICAL 20121215 OTC MONOGRAPH FINAL part333D Valu Merchandisers Company SALICYLIC ACID 20 mg/mL N 20181231 63941-788_214b2857-2a9e-4256-a98b-cf0bf8ee3594 63941-788 HUMAN OTC DRUG Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20171215 OTC MONOGRAPH FINAL part352 VALU MERCHANDISERS, CO AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27.03; 135.15; 45.05; 90.1; 54.06 mg/g; mg/g; mg/g; mg/g; mg/g N 20191231 63941-804_d11f7c2f-6b1e-439a-aca5-1615de1e646c 63941-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20141022 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, CO ISOPROPYL ALCOHOL 91 mg/mL N 20181231 63941-810_f453ae61-6b58-4adf-abc9-8235065a2193 63941-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20031124 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, CO. ISOPROPYL ALCOHOL 500 mg/mL N 20181231 63941-831_49376b4d-d2fd-6472-e054-00144ff88e88 63941-831 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20120716 OTC MONOGRAPH FINAL part333B Valu Merchandisers, Co. POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC 5000; 3.5; 400 [USP'U]/g; mg/g; [USP'U]/g N 20181231 63941-835_f245bfc0-1ebf-4302-9f84-eac80c894b1f 63941-835 HUMAN OTC DRUG Best Choice Earwax Removal Kit Carbamide peroxide LIQUID TOPICAL 20141127 OTC MONOGRAPH FINAL part344 Valu Merchandisers, Co. CARBAMIDE PEROXIDE 65 mg/mL N 20181231 63941-845_4505791a-330b-4123-9a89-d4c0858664e6 63941-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20141024 OTC MONOGRAPH FINAL part344 Valu Merchandisers, Co ISOPROPYL ALCOHOL 613 mg/mL N 20181231 63941-871_e0af4081-b632-4327-957c-48f4275a086d 63941-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20030715 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, co HYDROGEN PEROXIDE 30 mg/mL N 20181231 63941-890_ec5b62a2-b9ae-425e-b1fc-8be1924f0256 63941-890 HUMAN OTC DRUG Sinus and Allergy PE maximum strength Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20100722 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 63941-891_8c43938b-e23f-41b9-beb4-0c22fe2cae54 63941-891 HUMAN OTC DRUG Cold and Allergy Relief Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20141231 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 63941-939_5e0f3eec-fc33-40e0-9992-5310fc9452c3 63941-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Valu Merchandisers Company CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 63941-941_93cecb4f-745c-4e5d-8d70-2ad4c4d99093 63941-941 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20160119 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, Co BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 63941-944_8b152b25-116b-4b44-9b2d-9413c63619fa 63941-944 HUMAN OTC DRUG childrens pain reliever acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Valu Merchandisers Company ACETAMINOPHEN 160 mg/1 N 20181231 63941-945_b0c4b716-d634-4101-be6e-d237c7382e3f 63941-945 HUMAN OTC DRUG Body Wash triclosan LIQUID TOPICAL 20090106 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, Co TRICLOSAN 1.5 mg/mL N 20181231 63941-949_ec9e844d-0b99-417f-9b41-acaaeab36fe8 63941-949 HUMAN OTC DRUG Cold and Hot Medicated Pain Relief Large Menthol PATCH TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers Company, Inc. MENTHOL 875 mg/1 N 20181231 63941-950_ff0871b2-0363-463a-bf7e-7399370fd32d 63941-950 HUMAN OTC DRUG Cold and Hot Medicated Pain Relief Small Menthol PATCH TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part348 Valu Merchandisers Company, Inc. MENTHOL 400 mg/1 E 20171231 63941-951_286190f8-0e07-41a3-aa43-46f78927062b 63941-951 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120816 OTC MONOGRAPH NOT FINAL part333A Valu Merchandisers, CO ALCOHOL 578 mg/mL N 20181231 63941-952_c6336d7d-3b3e-428c-a999-2720b4638348 63941-952 HUMAN OTC DRUG Dry Scalp Pyrithione zinc SHAMPOO TOPICAL 20090106 OTC MONOGRAPH FINAL part358H Valu Merchandisers Co. PYRITHIONE ZINC 10 mg/mL N 20181231 63941-970_43e06f54-7f98-4c17-b975-aeda195de489 63941-970 HUMAN OTC DRUG Allergy Antihistamine Diphenhydramine HCl CAPSULE ORAL 20100810 OTC MONOGRAPH FINAL part341 Best Choice (Valu Merchandisers Company) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 63956-001_9f210a1f-556a-4ad0-8427-4620a5fc33e1 63956-001 HUMAN OTC DRUG emmi dent Sodium Fluoride Anticavity Mild SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20140422 OTC MONOGRAPH FINAL part355 EMAG AG SODIUM FLUORIDE .16 g/100g E 20171231 63961-003_c8a28ec1-13e6-4d0f-bcac-58b6747e2fdc 63961-003 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20110201 UNAPPROVED MEDICAL GAS Middlesex Gases and Technologies, Inc. AIR 1000 mL/L E 20171231 63961-100_b13a7985-734a-408e-bb14-d8a3f4f133fa 63961-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19970728 NDA NDA205849 Middlesex Gases and Technologies, Inc. OXYGEN 990 mL/L N 20181231 63961-200_91984178-6b40-4aa5-b742-2c64dc61d942 63961-200 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19970728 NDA NDA205850 Middlesex Gases and Technologies, Inc. NITROGEN 990 mL/L N 20181231 63961-300_6141e1ac-4f4c-35b1-e053-2991aa0a6895 63961-300 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20110201 NDA NDA205849 Middlesex Gases & Technologies, Inc. OXYGEN 210 mL/L N 20181231 63972-001_6fc5032b-1141-4d1b-aae6-29fb55cffd69 63972-001 HUMAN OTC DRUG 1 Detoxification Capsicum Annuum, Phytolacca Decandra, Trifolium Pratense, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium Metallicum, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Oxydatum, Ferrum Metallicum, Gadolinium Oxydatum, Germanium Sesquioxide, Holmium, LIQUID ORAL 20150812 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics CAPSICUM; PHYTOLACCA AMERICANA ROOT; TRIFOLIUM PRATENSE FLOWER; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LANTHANUM OXIDE; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM; SAMARIUM OXIDE; SELENIUM; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; CORTICOTROPIN; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; SUS SCROFA PITUITARY GLAND; ANGUILLA ROSTRATA BLOOD SERUM; TARTARIC ACID; THERIDION CURASSAVICUM; SUS SCROFA THYROID; APIS MELLIFERA; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARBO ANIMALIS; ACTIVATED CHARCOAL; HUMAN BREAST TUMOR CELL; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; CLAVICEPS PURPUREA SCLEROTIUM; STRYCHNOS WALLICHIANA BARK; SULFURIC ACID; ALLYLTHIOUREA; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT; ALCOHOL, X-RAY EXPOSED (1000 RAD) 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 63972-002_369ec9a7-1d45-4010-86b2-8098a2dad2b3 63972-002 HUMAN OTC DRUG CENTURY 21 LYMPHATIC DRAINAGE STRYCHNOS NUX-VOMICA SEED, BARIUM CHLORIDE DIHYDRATE, LACHESIS MUTA VENOM, CONIUM MACULATUM FLOWERING TOP, GOLDENSEAL, IODINE, SILICON DIOXIDE, PHOSPHORUS, QUININE SULFATE, SILYBUM MARIANUM SEED, CHELIDONIUM MAJUS, BERBERIS VULGARIS ROOT BARK, SONIA CANADENSIS ROOT, MERCURIUS SOLUBILIS, CEANOTHUS AMERICANUS LEAF, SOLIDAGO VIRGAUREA FLOWERING TOP, BOS TAURUS BILE, APIS MELLIFERA LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc STRYCHNOS NUX-VOMICA SEED; BARIUM CHLORIDE DIHYDRATE; LACHESIS MUTA VENOM; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; IODINE; SILICON DIOXIDE; PHOSPHORUS; QUININE SULFATE; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; BERBERIS VULGARIS ROOT BARK; COLLINSONIA CANADENSIS ROOT; MERCURIUS SOLUBILIS; CEANOTHUS AMERICANUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS BILE; APIS MELLIFERA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL E 20171231 63972-003_61c2f388-041b-448a-b66a-b30f1364fce6 63972-003 HUMAN OTC DRUG CENTURY 21 ACUTE STRESS ARNICA MONTANA, ARSENIC TRIOXIDE, BELLIS PERENNIS, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, APIS MELLIFERA, HUMAN BREAST TUMOR CELL, HELIANTHEMUM CANADENSE, CLEMATIS RECTA FLOWERING TOP, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, LACHESIS MUTA VENOM, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM CHLORIDE, SODIUM SULFATE, ORNITHOGALUM UMBELLATUM, PHOSPHORIC ACID, SALIX NIGRA BARK, DELPHINIUM STAPHISAGRIA SEED LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc ARNICA MONTANA; ARSENIC TRIOXIDE; BELLIS PERENNIS; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; APIS MELLIFERA; HUMAN BREAST TUMOR CELL; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM SULFATE; ORNITHOGALUM UMBELLATUM; PHOSPHORIC ACID; SALIX NIGRA BARK; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL E 20171231 63972-004_64baaa23-56a2-4689-bfa0-a2c44f4b23ff 63972-004 HUMAN OTC DRUG CENTURY 21 DETOX-VIRUS ARANEUS DIADEMATUS, RANCID BEEF, PHYTOLACCA AMERICANA ROOT, ECHINACEA ANGUSTIFOLIA, ASTRAGALUS PROPINQUUS ROOT, BAPTISIA TINCTORIA ROOT, GOLDENSEAL, LACHESIS MUTA VENOM, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA, EUPATORIUM PERFOLIATUM FLOWERING TOP, ARSENIC TRIOXIDE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIG, BILBERRY, APIS MELLIFERA LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc ARANEUS DIADEMATUS; RANCID BEEF; PHYTOLACCA AMERICANA ROOT; ECHINACEA ANGUSTIFOLIA; ASTRAGALUS PROPINQUUS ROOT; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; GELSEMIUM SEMPERVIRENS ROOT; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; ARSENIC TRIOXIDE; PHOSPHORIC ACID; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; BILBERRY; APIS MELLIFERA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL E 20171231 63972-005_1b730cce-8e56-47c0-8f37-c196afc6bd91 63972-005 HUMAN OTC DRUG 5 Chronic Stress Aralia Quinquefolia, Fucus Vesiculosus, Hydrastis Canadensis, Solidago Virgaurea, Taraxacum Officinale, Trifolium Pratense, Arsenicum Album, Calcarea Carbonica, Carbo Vegetabilis, Ceanothus Americanus, Cyclamen Europaeum, Hepar Sulphuris Calcareum, Natrum Muriaticum, Nux Vomica, Petroleum, Phosphorus LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc AMERICAN GINSENG; FUCUS VESICULOSUS; GOLDENSEAL; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; CEANOTHUS AMERICANUS LEAF; CYCLAMEN PURPURASCENS TUBER; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORUS 30; 3; 30; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 63972-006_c55f94c7-947d-4001-bc8f-f0bbd17f55ea 63972-006 HUMAN OTC DRUG 6 Environmental Detox ACTH, Calcarea carbonica, Magnesia sulphurica, Kali phosphoricum, Nitricum acidum, Benzoicum acidum, Silicea, Arsenicum album, Mercuris solubilis, Phosphorus, Carbo vegetabilis, Nux vomica, Aluminum metallicum, Phytolacca decandra, Baptisia tinctoria, Argentum nitricum, Spigelia anthelmia, Apis mellifica LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc BAPTISIA TINCTORIA ROOT; PHYTOLACCA AMERICANA ROOT; SPIGELIA ANTHELMIA; CORTICOTROPIN; ALUMINUM; APIS MELLIFERA; SILVER NITRATE; ARSENIC TRIOXIDE; BENZOIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM SULFATE HEPTAHYDRATE; MERCURIUS SOLUBILIS; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SILICON DIOXIDE 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 63972-007_c73f0f05-dfb8-4134-baf7-f08eaad29942 63972-007 HUMAN OTC DRUG CENTURY 21 HEAVY METAL DETOX GARLIC, GOLD, ATROPA BELLADONNA, BERBERIS VULGARIS ROOT BARK, CAUSTICUM, CONIUM MACULATUM FLOWERING TOP, CALCIUM SULFIDE, HYPERICUM PERFORATUM, IPECAC, ALUMINUM, SILVER, ARSENIC, BARIUM CARBONATE, BERYLLIUM, BORON, BROMINE, CADMIUM, D and C BLACK NO. 2, CERIUM, CESIUM, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, IRON, FLUORINE, GADOLINIUM, GALLIUM, GERMANIUM, HOLMIUM, HYDROGEN, INDIUM, IODINE, LANTHANUM, LITHIUM CARBONATE, MANGANESE, MERCURIUS SOLUBILIS, MOLYBDENUM, NEODYMIUM, NICKEL LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc GARLIC; GOLD; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; CALCIUM SULFIDE; HYPERICUM PERFORATUM; IPECAC; ALUMINUM; SILVER; ARSENIC; BARIUM CARBONATE; BERYLLIUM; BORON; BROMINE; CADMIUM; D&C BLACK NO. 2; CERIUM; CESIUM; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; FLUORINE; GADOLINIUM; GALLIUM; GERMANIUM; HOLMIUM; HYDROGEN; INDIUM; IODINE; LANTHANUM; LITHIUM CARBONATE; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM; NICKEL; NIOBIUM; NITROUS OXIDE; OXYGEN; LEAD; PRASEODYMIUM; RUBIDIUM; SAMARIUM; SCANDIUM; SELENIUM; SILICON DIOXIDE; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THULIUM; TITANIUM; VANADIUM; YTTERBIUM; ZINC; VERATRUM ALBUM ROOT; APIS MELLIFERA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_C]/5mL E 20171231 63972-008_0dcd995f-444a-4daf-9f96-fde8b3d6ce6b 63972-008 HUMAN OTC DRUG CENTURY 21 FUNGAL YEAST INFECTION CANDIDA ALBICANS, SEPIA OFFICINALIS JUICE, ECHINACEA, UNSPECIFIED, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, THUJA OCCIDENTALIS LEAFY TWIG, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ASTRAGALUS PROPINQUUS ROOT, MERCURIUS SOLUBILIS, GOLDENSEAL, PHYTOLACCA AMERICANA ROOT, BERBERIS VULGARIS ROOT BARK, GENTIANA LUTEA ROOT, APIS MELLIFERA LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc CANDIDA ALBICANS; SEPIA OFFICINALIS JUICE; ECHINACEA, UNSPECIFIED; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ASTRAGALUS PROPINQUUS ROOT; MERCURIUS SOLUBILIS; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; BERBERIS VULGARIS ROOT BARK; GENTIANA LUTEA ROOT; APIS MELLIFERA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL E 20171231 63972-009_acd58147-7ff9-4115-91f8-581c31f124c6 63972-009 HUMAN OTC DRUG CENTURY 21 BACTERIAL DETOX ECHINACEA ANGUSTIFOLIA, BAPTISIA TINCTORIA ROOT, PHYTOLACCA AMERICANA ROOT, FERROSOFERRIC PHOSPHATE, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA RECUTITA, MERCURIUS SOLUBILIS, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, SOLANUM DULCAMARA TOP, RANCID BEEF, GARLIC, APIS MELLIFERA LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc ECHINACEA ANGUSTIFOLIA; BAPTISIA TINCTORIA ROOT; PHYTOLACCA AMERICANA ROOT; FERROSOFERRIC PHOSPHATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; SOLANUM DULCAMARA TOP; RANCID BEEF; GARLIC; APIS MELLIFERA 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL E 20171231 63972-010_c0053f43-e333-4c75-a6b2-d848f2d6ec26 63972-010 HUMAN OTC DRUG 10 PARASITE DETOX Carduus Marianus, Chelidonium Majus, Cina, Sabadilla, Spigelia Anthelmia, Teucrium Marum, Terebinthina, Thyroidinum (Suis), Apis Mellifica, Baryta Carbonica, Calcarea Carbonica, Ferrum Muriaticum, Natrum Muriaticum, Silicea, Sulphur LIQUID ORAL 19750101 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics BARIUM CARBONATE; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; ARTEMISIA MARITIMA FLOWER; FERRIC CHLORIDE HEXAHYDRATE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; SULFUR; THYROID, UNSPECIFIED; APIS MELLIFERA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TURPENTINE OIL; TEUCRIUM MARUM 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 5; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 63972-011_32a38e19-ce7c-44c9-95c6-5a40bae9c5b8 63972-011 HUMAN PRESCRIPTION DRUG 3 Acute Stress Arnica Montana, Bellis Perennis, Passiflora Incarnata, Valeriana Officinalis, Arsenicum Album, Apis Mellifica, Carcinosin, Cistus Canadensis, Clematis Erecta, Coffea Cruda, Ignatia Amara, Lachesis Mutus, Magnesia Phosphorica, Natrum Muriaticum, Natrum Sulphuricum, Ornithogalum Umbellatum, Phosphoricum Acidum, Salix Nigra, Staphysagria LIQUID ORAL 20151106 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics ARNICA MONTANA; BELLIS PERENNIS; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; ARSENIC TRIOXIDE; APIS MELLIFERA; HUMAN BREAST TUMOR CELL; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM SULFATE; ORNITHOGALUM UMBELLATUM; PHOSPHORIC ACID; SALIX NIGRA BARK; DELPHINIUM STAPHISAGRIA SEED 3; 3; 3; 3; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 63972-012_4bd38fc7-7e11-411f-9e12-3667fbb91392 63972-012 HUMAN OTC DRUG 7 Heavy Metal Detox Allium Sativum, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, LIQUID ORAL 20151109 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics GARLIC; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; LANTHANUM; APIS MELLIFERA; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; CALCIUM SULFIDE; HYPERICUM PERFORATUM; IPECAC; NIOBIUM; TANTALUM; VERATRUM ALBUM ROOT 4; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 14; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 63972-013_52efe4bd-b1ab-4ea3-8b80-c217c183cc31 63972-013 HUMAN OTC DRUG 1 Detoxification Capsicum Annuum, Phytolacca Decandra, Trifolium Pratense, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium Metallicum, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Oxydatum, Ferrum Metallicum, Gadolinium Oxydatum, Germanium Sesquioxide, Holmium, LIQUID ORAL 20151109 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics TRIFOLIUM PRATENSE FLOWER; CAPSICUM; PHYTOLACCA AMERICANA ROOT; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM OXIDE; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; CORTICOTROPIN; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; SUS SCROFA PITUITARY GLAND; ANGUILLA ROSTRATA BLOOD SERUM; TARTARIC ACID; THERIDION CURASSAVICUM; SUS SCROFA THYROID; LANTHANUM; APIS MELLIFERA; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CARBO ANIMALIS; ACTIVATED CHARCOAL; HUMAN BREAST TUMOR CELL; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS WALLICHIANA BARK; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NIOBIUM; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; CLAVICEPS PURPUREA SCLEROTIUM; SULFURIC ACID; TANTALUM; ALLYLTHIOUREA; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT; ALCOHOL, X-RAY EXPOSED (1000 RAD) 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 14; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 63972-014_b618fcec-cfc8-4248-86a4-1756e0b98860 63972-014 HUMAN OTC DRUG 2 Lymphatic Drainage Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, Collinsonia Canadensis, Solidago Virgaurea, Hydrastis Canadensis, Fel Tauri, Apis Mellifica, Baryta Muriatica, Ceanothus Americanus, Chininum Sulphuricum, Conium Maculatum, Iodium, Lachesis Mutus, Mercurius Solubilis, Nux Vomica, Phosphorus, Silicea LIQUID ORAL 20170113 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; GOLDENSEAL; BOS TAURUS BILE; APIS MELLIFERA; BARIUM CHLORIDE DIHYDRATE; CEANOTHUS AMERICANUS LEAF; QUININE SULFATE; IODINE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SILICON DIOXIDE 3; 3; 3; 3; 3; 5; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 63972-015_99ccd5d4-6bfe-4210-bd6e-3d6ad9c2a3f3 63972-015 HUMAN OTC DRUG 8 Fungal Yeast Infection Astragalus Membranaceus, Berberis Vulgaris, Echinacea (Angustifolia), Gentiana Lutea, Hydrastis Canadensis, Phytolacca Decandra, Candida Albicans, Apis Mellifica, Calcarea Carbonica, Lycopodium Clavatum, Mercurius Solubilis, Pulsatilla (Vulgaris) Sepia, Thuja Occidentalis LIQUID ORAL 20170116 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics, Inc ASTRAGALUS PROPINQUUS ROOT; BERBERIS VULGARIS ROOT BARK; ECHINACEA ANGUSTIFOLIA; GENTIANA LUTEA ROOT; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; CANDIDA ALBICANS; APIS MELLIFERA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAF 3; 3; 3; 3; 5; 3; 12; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 63972-016_8da4b5d0-7a30-41aa-b0a1-43891a364678 63972-016 HUMAN OTC DRUG 4 Detox-Virus Astragalus Membranaceus, Baptisia Tinctoria, Echinacea (Echinacea), Phytolacca Decandra, Hydrastis Canadensis, Apis Mellifica, Aranea Diadema, Belladonna, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lachesis Mutus, Phosphoricum Acidum, Silicea, Thuja Occidentalis, Vaccinium Myrtillus LIQUID ORAL 20170929 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics ASTRAGALUS PROPINQUUS ROOT; BAPTISIA TINCTORIA; ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; APIS MELLIFERA; ARANEUS DIADEMATUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; PHOSPHORIC ACID; RANCID BEEF; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; BILBERRY 3; 3; 3; 3; 5; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 63972-017_c7f02065-bdc4-4b0d-a9f9-d1d241154686 63972-017 HUMAN OTC DRUG 10 Parasite Detox Carduus Marianus, Chelidonium Majus, Cina, Sabadilla, Spigelia Anthelmia, Teucrium Marum, Terebinthina, Thyroidinum (Suis), Spigelia Anthelmia, Apis Mellifica, Baryta Carbonica, Calcarea Carbonica, Ferrum Muriaticum, Natrum Muriaticum, Silicea, Sulphur LIQUID ORAL 20171229 UNAPPROVED HOMEOPATHIC 21st Century Homeopathics MILK THISTLE; CHELIDONIUM MAJUS; ARTEMISIA CINA PRE-FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; TEUCRIUM MARUM; TURPENTINE OIL; SUS SCROFA THYROID; SPIGELIA ANTHELMIA; APIS MELLIFERA; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FERRIC CHLORIDE HEXAHYDRATE; SODIUM CHLORIDE; SILICON DIOXIDE; SULFUR 3; 3; 3; 3; 3; 5; 6; 6; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20191231 63978-001_c484cbe3-ec7e-4b66-8818-76cb472f4f7b 63978-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800101 NDA NDA205712 AIR SUPPLY OF NORTH TEXAS OXYGEN 990 mL/L N 20181231 63978-201_342a8420-097f-4702-82a5-a221339f5991 63978-201 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20090101 NDA NDA206009 AIR SUPPLY OF NORTH TEXAS NITROUS OXIDE 990 mL/L E 20171231 63981-001_bf1512e9-01fe-42e9-8465-61c4aaf894cd 63981-001 HUMAN OTC DRUG Kirkland Signature Aller Flo Fluticasone propionate SPRAY, METERED NASAL 20160529 ANDA ANDA207957 Costco Wholesale Company FLUTICASONE PROPIONATE 50 ug/1 N 20191231 63981-012_17f17eb6-ebc3-4a71-9f1b-41e2b5dcf6c1 63981-012 HUMAN OTC DRUG Kirkland Signature Quit 2 Nicotine polacrilex GUM, CHEWING ORAL 20170321 ANDA ANDA206394 Costco Wholesale Company NICOTINE 2 mg/1 N 20181231 63981-013_afa094b3-a394-4d16-8a14-50cb51ac54c2 63981-013 HUMAN OTC DRUG Kirkland Signature AllerClear D 12 hr Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20130110 ANDA ANDA076050 Costco Wholesale Company LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 63981-029_6382d728-17df-4c5f-91f6-6367ce0bf36c 63981-029 HUMAN OTC DRUG kirkland signature quit 2 Nicotine Polacrilex GUM, CHEWING ORAL 20120515 ANDA ANDA076775 Costco Wholesale Company NICOTINE 2 mg/1 N 20181231 63981-100_a2c187ce-2da4-4efc-8bd0-cd3820f89dd5 63981-100 HUMAN OTC DRUG KIRKLAND SIGNATURE PRO-COMPLETE plus WHITENING sodium fluoride PASTE ORAL 20100913 20180630 OTC MONOGRAPH FINAL part355 Costco Wholesale Corporation SODIUM FLUORIDE 1.5 mg/g E 20171231 63981-101_a2c187ce-2da4-4efc-8bd0-cd3820f89dd5 63981-101 HUMAN OTC DRUG KIRKLAND SIGNATURE PRO-COMPLETE plus WHITENING sodium fluoride PASTE ORAL 20160901 OTC MONOGRAPH FINAL part355 Costco Wholesale Corporation SODIUM FLUORIDE 1.5 mg/g N 20181231 63981-110_62c5bc91-dc43-4c56-a304-a41bb451379a 63981-110 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130730 OTC MONOGRAPH NOT FINAL part334 Costco Wholesale DOCUSATE SODIUM 100 mg/1 N 20181231 63981-111_fc4ad05c-3d62-4450-8fad-95f1d4ffdc29 63981-111 HUMAN OTC DRUG Mens Kirkland Extra Strength Minoxidil SOLUTION TOPICAL 20100716 NDA NDA020834 Costco Wholesale Corporation MINOXIDIL 50 mg/mL N 20181231 63981-117_ae08b32e-971d-4891-aa06-6feb11bfd023 63981-117 HUMAN OTC DRUG Kirkland Signature Lansoprazole Delayed Release Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20131217 ANDA ANDA202319 Costco Wholesale Company LANSOPRAZOLE 15 mg/1 N 20181231 63981-159_39f58dea-8be5-4fc9-bd45-d6458b55b098 63981-159 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 63981-170_aea70441-b137-4761-9727-50bae5542f22 63981-170 HUMAN OTC DRUG kirkland signature quit 4 Nicotine Polacrilex GUM, CHEWING ORAL 20120507 ANDA ANDA076789 Costco Wholesale Company NICOTINE 4 mg/1 N 20181231 63981-176_b2cc0758-c4b4-4671-a0df-b0e13707fbee 63981-176 HUMAN OTC DRUG Kirkland Signature Aller Tec D Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080421 ANDA ANDA077170 Costco Wholesale Company CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 63981-194_270ebd32-63d7-4730-93ed-976d27e78a64 63981-194 HUMAN OTC DRUG kirkland signature acid controller Famotidine TABLET ORAL 20070524 ANDA ANDA077351 Costco Wholesale Company FAMOTIDINE 20 mg/1 N 20181231 63981-199_73d26ed1-9507-4681-84e1-f1ed16bef907 63981-199 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20100708 ANDA ANDA078682 Costco Wholesale IBUPROFEN 200 mg/1 N 20181231 63981-224_84a1565b-89de-4843-814f-4b60a736ba60 63981-224 HUMAN OTC DRUG kirkland signature anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030226 ANDA ANDA075232 Costco Wholesale Company LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 63981-227_4fdf24f0-c899-4f55-9d91-d6d767aae05d 63981-227 HUMAN OTC DRUG Aspirin Safety Coated Enteric, Regular Strength Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ASPIRIN 325 mg/1 N 20191231 63981-239_54830576-5813-483a-b699-defa041e9bc3 63981-239 HUMAN OTC DRUG ALLERCLEAR-D 24 Hour Loratadine and Pseudoephedrine Sulfate TABLET, EXTENDED RELEASE ORAL 20160301 ANDA ANDA075706 Costco Wholesale Corporation LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 63981-291_ec784128-75b0-401c-9613-dba0291ae7a9 63981-291 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 COSTCO WHOLESALE CORPORATION IBUPROFEN 200 mg/1 N 20181231 63981-294_f4fada10-f3fb-4d5e-a9bf-addc1e605d4a 63981-294 HUMAN OTC DRUG kirkland signature Minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20120417 ANDA ANDA091344 Costco Wholesale Company MINOXIDIL 5 g/100g N 20181231 63981-306_14416004-b58a-4d36-abfe-dcb663827872 63981-306 HUMAN OTC DRUG kirkland signature laxaclear original prescription strength Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091107 ANDA ANDA090685 Costco Wholesale Company POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 63981-309_bfdf3918-3116-4351-b0a8-4c515e2e1f41 63981-309 HUMAN OTC DRUG kirkland signature quit 4 Nicotine Polacrilex GUM, CHEWING ORAL 20170321 ANDA ANDA206393 Costco Wholesale Company NICOTINE 4 mg/1 N 20181231 63981-329_247abb98-dacd-428e-9b7a-98ad3c3ee191 63981-329 HUMAN OTC DRUG Allergy Medicine Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 COSTCO WHOLESALE CORPORATION DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 63981-344_5ba79b57-cded-416c-b790-2f8bbe7e15f2 63981-344 HUMAN OTC DRUG kirkland signature quit 2 Nicotine Polacrilex LOZENGE ORAL 20140912 ANDA ANDA077007 Costco Wholesale Company NICOTINE 2 mg/1 N 20181231 63981-368_a3952393-e345-4ad5-9b2e-31d120426967 63981-368 HUMAN OTC DRUG kirkland signature naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20070604 ANDA ANDA074661 Costco Wholesale Company NAPROXEN SODIUM 220 mg/1 N 20181231 63981-380_0bc49c0f-5833-47ce-82c6-098cbf5c7c27 63981-380 HUMAN OTC DRUG Kirkland Signature Minoxidil Minoxidil SOLUTION TOPICAL 20130825 ANDA ANDA075598 Costco Wholesale Company MINOXIDIL 5 g/100mL N 20181231 63981-386_523540be-7004-4554-978e-0fb0e7f6f2f9 63981-386 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 COSTCO WHOLESALE CORPORATION DOXYLAMINE SUCCINATE 25 mg/1 N 20191231 63981-393_cc8e494d-adfd-4d4f-92a0-417dc85cb550 63981-393 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 COSTCO WHOLESALE CORPORATION IBUPROFEN 200 mg/1 N 20181231 63981-453_99fda970-386d-4147-b601-4bcf21a63b06 63981-453 HUMAN OTC DRUG Suphedrine PE Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 OTC MONOGRAPH FINAL part341 COSTCO WHOLESALE CORPORATION PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 63981-458_6e5479a7-2e63-4385-a61c-d9e97bbe61cd 63981-458 HUMAN OTC DRUG kirkland signature aller tec allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20080325 ANDA ANDA078336 Costco Wholesale Company CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 63981-473_9819094e-0158-4e10-9a30-6cdf8c2d1b54 63981-473 HUMAN OTC DRUG Cold and Flu Multi-Symptom Nighttime Severe Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCl TABLET, FILM COATED ORAL 20050721 OTC MONOGRAPH FINAL part341 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 63981-475_eb14a311-7918-4c4b-ae05-7606cfb8a4af 63981-475 HUMAN OTC DRUG Kirkland Signature Childrens Aller Tec Cetirizine HCl SOLUTION ORAL 20160708 ANDA ANDA204226 Costco Wholesale Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 63981-517_7e3b6824-2090-4a6a-ba91-5e42fe878ae3 63981-517 HUMAN OTC DRUG kirkland signature ibuprofen ib Ibuprofen TABLET, FILM COATED ORAL 20070622 ANDA ANDA077349 Costco Wholesale Company IBUPROFEN 200 mg/1 N 20181231 63981-519_2a27ac2f-58e5-4078-8646-c1dfecce9449 63981-519 HUMAN OTC DRUG RAPID RELEASE ACETAMINOPHEN Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN 500 mg/1 N 20191231 63981-532_9b004c4d-3bd0-46ea-9d18-fd22062c855f 63981-532 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, FILM COATED ORAL 20051222 OTC MONOGRAPH FINAL part341 COSTCO WHOLESALE CORPORATION GUAIFENESIN 400 mg/1 N 20191231 63981-556_3adac593-a0c1-41a4-911e-15be05e39fac 63981-556 HUMAN OTC DRUG Rapid Release Acetaminophen PM Extra Strength Acetaminophen and Diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20191231 63981-560_ed6780ea-3937-22e7-63d7-1c1567e9841b 63981-560 HUMAN OTC DRUG Multi-Symptom Daytime Cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20080329 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 63981-563_e432bb04-a4ed-49b0-a0dd-80350d041774 63981-563 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ASPIRIN 81 mg/1 N 20191231 63981-571_0581073c-22f1-41d7-aa92-e62fe52c5ddf 63981-571 HUMAN OTC DRUG kirkland signature aller fex fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110423 ANDA ANDA076447 Costco Wholesale Company FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 63981-591_1cd7ee36-b92d-41e9-b011-834fc2343a56 63981-591 HUMAN OTC DRUG Cold Multi-Symptom Nighttime Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20080329 20201128 OTC MONOGRAPH FINAL part341 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20191231 63981-591_fc1f2fa5-a67a-ec2d-2226-94e8519fae83 63981-591 HUMAN OTC DRUG Nighttime Cold Multi Symptom Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20100625 OTC MONOGRAPH NOT FINAL part343 COSTCO WHOLESALE CORPORATION ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20191231 63981-604_abc087c7-8df9-44fb-a865-16d0eb6c8689 63981-604 HUMAN OTC DRUG kirkland signature ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20030625 ANDA ANDA072096 Costco Wholesale Company IBUPROFEN 200 mg/1 N 20181231 63981-612_b8d6173f-556d-490c-adce-2a3b9aafcca4 63981-612 HUMAN OTC DRUG kirkland signature allerclear Loratadine TABLET ORAL 20101015 ANDA ANDA076301 Costco Wholesale Company LORATADINE 10 mg/1 N 20181231 63981-664_fa65878d-eb24-4f69-bbf8-a188f1b7783e 63981-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20110614 OTC MONOGRAPH NOT FINAL part356 Costco Wholesale Corporation EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 63981-700_0aefaaca-b014-49e3-a731-8cf26d066566 63981-700 HUMAN OTC DRUG kirkland signature acetaminophen adult extra strength Acetaminophen TABLET ORAL 20090603 OTC MONOGRAPH NOT FINAL part343 Costco Wholesale Company ACETAMINOPHEN 500 mg/1 N 20181231 63981-701_49ae28ef-389b-4e62-b3b4-8f2e1d6c75d8 63981-701 HUMAN OTC DRUG Cold Relief Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20050721 20200616 OTC MONOGRAPH FINAL part341 COSTCO WHOLESALE CORPORATION N 20181231 63981-702_63e809ce-986c-4b72-90e9-6b7289a467a3 63981-702 HUMAN OTC DRUG Cold and Flu Multi-Symptom Daytime/Nighttime Severe Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Guaifenesin and Phenylephrine HCl KIT 20050804 OTC MONOGRAPH FINAL part341 COSTCO WHOLESALE CORPORATION N 20181231 63981-724_2ba213f7-3f7a-40e5-abd9-44d937e9a91f 63981-724 HUMAN OTC DRUG KIRKLAND SIGNATURE ALLERCLEAR D 12 HR Extended Release loratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE ORAL 20170825 ANDA ANDA076557 Kirkland-COSTCO WHOLESALE COMPANY LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20191231 63981-798_78c68e80-6646-452c-bd65-527428d422d4 63981-798 HUMAN OTC DRUG kirkland signature minoxidil Minoxidil SOLUTION TOPICAL 20120522 ANDA ANDA075598 Costco Wholesale Company MINOXIDIL 3 g/60mL N 20181231 63981-852_c13d85cc-c9e5-467b-9376-41dc62e0e88f 63981-852 HUMAN OTC DRUG Kirkland Signature Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130424 ANDA ANDA091429 Costco Wholesale Company RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 63981-873_4c351042-bc8b-4043-a161-9cb840f8ee3e 63981-873 HUMAN OTC DRUG kirkland signature quit 4 Nicotine Polacrilex LOZENGE ORAL 20140912 ANDA ANDA077007 Costco Wholesale Company NICOTINE 4 mg/1 N 20181231 63981-898_4a87d5d5-c98b-4dc5-81be-50183342b047 63981-898 HUMAN OTC DRUG kirkland signature esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170922 ANDA ANDA207193 Costco Wholesale Company ESOMEPRAZOLE 20 mg/1 N 20181231 63981-915_cedb2cb8-f5d2-4863-927a-d229f6b5b69d 63981-915 HUMAN OTC DRUG kirkland signature omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080227 NDA NDA022032 Costco Wholesale Company OMEPRAZOLE 20 mg/1 N 20181231 63981-973_cbbdb988-58d8-4aec-95e7-c906e181b6e0 63981-973 HUMAN OTC DRUG kirkland signature hydrocortisone plus maximum strength hydrocortisone CREAM TOPICAL 20091002 OTC MONOGRAPH NOT FINAL part348 Costco Wholesale Company HYDROCORTISONE 1 g/100g N 20181231 63983-0001_a3b88bfd-3a79-4478-8c1b-cf3f937f30cd 63983-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980213 UNAPPROVED MEDICAL GAS Community Medical Equipment OXYGEN 99 L/100L E 20171231 63998-515_1c12dde5-9db7-4f27-b0e9-f4869a24b5c3 63998-515 HUMAN OTC DRUG United Laboratories 464 PUMP and PROTECT Alcohol Hand Sanitizer alcohol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 United Laboratories Inc. ALCOHOL 600 mL/1000mL E 20171231 63998-575_3d005536-a9d3-423a-a365-c0ac895371c7 63998-575 HUMAN OTC DRUG MicroMousse II Alcohol Free Hand Sanitizing Foam BENZETHONIUM CHLORIDE LIQUID TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 United Laboratories, Inc. BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 64009-056_a9274243-02b2-4e86-abb1-924f52c19ded 64009-056 HUMAN OTC DRUG Clean Xpress Alcohol Gel Instant Skin Sanitizer Clean Xpress Alcohol Gel Instant Skin Santizer LIQUID TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part333A Spartan Chemical Company, Inc. ALCOHOL 65.2 mL/100mL E 20171231 64009-305_9288eba5-387f-4247-8a53-52f8e1f31c6c 64009-305 HUMAN OTC DRUG Spartan E2 Hand Wash and Sanitizer Benzalkonium Chloride SOAP TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part333E Spartan Chemical Company, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 64009-331_dac33ded-37a3-4214-bd52-d57c50fbd25a 64009-331 HUMAN OTC DRUG Lite nFoamy Lemon Blossom Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part333A Spartan Chemical Company BENZALKONIUM CHLORIDE 1 g/L E 20171231 64009-332_bb5f0c4a-b064-4769-b3fa-526184192710 64009-332 HUMAN OTC DRUG Lite nFoamy Eucalyptus Mint Sanitizing Handwash Benzalkonium Chloride SOAP TOPICAL 20140414 OTC MONOGRAPH NOT FINAL part333A Spartan Chemical Company BENZALKONIUM CHLORIDE 1.3 g/L E 20171231 64009-333_f77d4826-62b0-4f10-b46e-5dd9d7cff0c7 64009-333 HUMAN OTC DRUG Lite nFoamy E2 Sanitizing Handwash Benzalkonium Chloride SOAP TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Spartan Chemical Company BENZALKONIUM CHLORIDE 1.3 g/L E 20171231 64009-334_e54a464e-204a-40df-884e-634ca7051911 64009-334 HUMAN OTC DRUG Lite nFoamy E3 Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part333A Spartan Chemical Company BENZALKONIUM CHLORIDE 1 g/L E 20171231 64009-335_ec3b4edd-5e96-4df5-a005-9b316750defe 64009-335 HUMAN OTC DRUG Lite nFoamy Healthcare Personnel Handwash Chloroxylenol SOAP TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A Spartan Chemical Company CHLOROXYLENOL 10.11 g/L E 20171231 64009-336_0648bf15-a463-4e2d-a4b2-31df0a3abdac 64009-336 HUMAN OTC DRUG Antiseptic Hand Cleaner Chloroxylenol SOAP TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part333A Spartan Chemical Company CHLOROXYLENOL 10.11 g/L E 20171231 64009-337_cb995959-0942-4235-9672-6f68afaa5d35 64009-337 HUMAN OTC DRUG Clean Xpress Antiseptic Hand Cleaner Chloroxylenol SOAP TOPICAL 20150213 OTC MONOGRAPH NOT FINAL part333E Spartan Chemical Company, Inc. CHLOROXYLENOL 10.1 mg/mL N 20181231 64009-360_1a64c2ab-ee0d-4f88-ae07-970b67b2d2b5 64009-360 HUMAN OTC DRUG Spartan Antiseptic Hand Cleaner Chloroxylenol SOAP TOPICAL 20131018 OTC MONOGRAPH NOT FINAL part333E Spartan Chemical Company, Inc. CHLOROXYLENOL 10.1 mg/mL E 20171231 64011-124_a96a8d64-4abd-4ef0-a2db-558d973c4029 64011-124 HUMAN PRESCRIPTION DRUG Clindesse clindamycin phosphate CREAM VAGINAL 20091101 NDA NDA050793 Ther-Rx Corporation CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 64011-215_9218e484-cb59-4bdc-a910-aeea2170646f 64011-215 HUMAN PRESCRIPTION DRUG Evamist estradiol SPRAY, METERED TRANSDERMAL 20090708 NDA NDA022014 Ther-Rx Corporation ESTRADIOL 1.53 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 64011-243_1947ea22-17d4-4239-98bf-a87cd5a707b9 64011-243 HUMAN PRESCRIPTION DRUG Makena hydroxyprogesterone caproate INJECTION INTRAMUSCULAR 20110203 NDA NDA021945 AMAG Pharmaceuticals, Inc. HYDROXYPROGESTERONE CAPROATE 250 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 64011-247_1947ea22-17d4-4239-98bf-a87cd5a707b9 64011-247 HUMAN PRESCRIPTION DRUG Makena hydroxyprogesterone caproate INJECTION INTRAMUSCULAR 20110203 NDA NDA021945 AMAG Pharmaceuticals, Inc. HYDROXYPROGESTERONE CAPROATE 250 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 64011-601_96d9ccee-3909-4f1d-8a53-1b1f373ed7ea 64011-601 HUMAN PRESCRIPTION DRUG Intrarosa Prasterone INSERT VAGINAL 20170606 NDA NDA208470 AMAG Pharmaceuticals, Inc. PRASTERONE 6.5 mg/1 N 20181231 64024-001_c9ff567d-a28f-4e99-baba-e62941d9f66c 64024-001 HUMAN OTC DRUG welby acetaminophen Acetaminophen TABLET ORAL 20160105 OTC MONOGRAPH NOT FINAL part343 Aldi, Inc ACETAMINOPHEN 500 mg/1 N 20181231 64024-002_abe3ea47-a99b-4115-add5-12d58ae92e51 64024-002 HUMAN OTC DRUG welby ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20160107 ANDA ANDA072096 Aldi, Inc IBUPROFEN 200 mg/1 N 20181231 64024-020_4568d777-8642-4349-8d8b-5e5f6f773047 64024-020 HUMAN OTC DRUG Diaper Rash Zinc oxide PASTE TOPICAL 20160927 OTC MONOGRAPH FINAL part347 ALDI Inc ZINC OXIDE 532 mg/g N 20181231 64024-100_7fdb7736-61c7-420f-a790-0a4af934f7f2 64024-100 HUMAN OTC DRUG Source Antibacterial Foaming Hand Original Triclosan LIQUID TOPICAL 20130104 OTC MONOGRAPH NOT FINAL part333A Aldi Inc. TRICLOSAN .46 mg/mL N 20181231 64024-175_1ef728ac-0554-49b6-a8a1-13fcd0e0939d 64024-175 HUMAN OTC DRUG Extra Strength Headache Relief Acetaminophen TABLET ORAL 19930402 20180828 OTC MONOGRAPH NOT FINAL part343 ALDI INC. ACETAMINOPHEN 500 mg/1 E 20171231 64024-180_1d991f6b-a8f1-4328-aaa1-3bd3dda9e006 64024-180 HUMAN OTC DRUG Healing petrolatum OINTMENT TOPICAL 20160922 OTC MONOGRAPH FINAL part347 ALDI Inc. PETROLATUM 340 mg/g N 20181231 64024-190_3635475f-c628-4061-80a1-3289e53d2123 64024-190 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part336 ALDI INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 64024-205_f0141885-edfe-4e69-83e2-6c13d557a888 64024-205 HUMAN OTC DRUG welby allergy relief Fluticasone propionate SPRAY, METERED NASAL 20170714 ANDA ANDA207957 Aldi, Inc FLUTICASONE PROPIONATE 50 ug/1 N 20181231 64024-255_1ab00c4e-86a9-4e92-a645-78bb10d403a7 64024-255 HUMAN OTC DRUG Welby Infants Ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20161221 ANDA ANDA075217 Aldi Inc IBUPROFEN 50 mg/1.25mL N 20181231 64024-306_56d3bab2-de5f-4aa0-8fb3-caa3f564ac82 64024-306 HUMAN OTC DRUG Welby ClearLax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20170821 ANDA ANDA090685 Aldi, Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 64024-370_89976c9d-9f47-409e-8a85-d5b7cc63e42b 64024-370 HUMAN OTC DRUG Hand Sanitizer Ethyl alcohol GEL TOPICAL 20140602 OTC MONOGRAPH NOT FINAL part333A Aldi Inc. ALCOHOL 700 mg/mL N 20181231 64024-459_536c4d4d-f6b8-478d-b4e9-1342e0c6cfa6 64024-459 HUMAN OTC DRUG welby nighttime cold and flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20170714 OTC MONOGRAPH FINAL part341 Aldi Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 64024-466_88eb7784-a095-446d-9207-68e813f7127f 64024-466 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20160217 OTC MONOGRAPH NOT FINAL part333A Aldi, Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 64024-479_73e1d377-0daf-4fd5-9754-c11dc3e24834 64024-479 HUMAN OTC DRUG welby allergy relief Diphenhydramine Hydrochloride TABLET ORAL 20170714 OTC MONOGRAPH FINAL part341 Aldi Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 64024-484_91f4047e-5c9d-4dd3-9a66-1ca8db58f04b 64024-484 HUMAN OTC DRUG welby health acetaminophen Acetaminophen TABLET ORAL 19910812 OTC MONOGRAPH NOT FINAL part343 Aldi, Inc ACETAMINOPHEN 500 mg/1 N 20181231 64024-499_cf6b3017-c8b6-4862-aa33-19ed02a43c28 64024-499 HUMAN OTC DRUG welby allergy relief Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20170714 ANDA ANDA078336 Aldi Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 64024-560_4c6409eb-7513-4168-aef6-3dcd2a2438f0 64024-560 HUMAN OTC DRUG Chloroxylenol Chloroxylenol LIQUID TOPICAL 20160429 OTC MONOGRAPH NOT FINAL part333A Aldi, Inc. CHLOROXYLENOL 3.09 mg/mL N 20181231 64024-604_470b76ef-9413-4cfc-96a4-ee95a2afce87 64024-604 HUMAN OTC DRUG welby health ibuprofen Ibuprofen TABLET ORAL 19930601 ANDA ANDA072096 Aldi, Inc IBUPROFEN 200 mg/1 N 20181231 64024-641_ca1cbf7c-7630-4bf0-9e54-60a3245a170a 64024-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333A Aldi,Inc BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 64024-656_9785ecfe-e94b-467d-8bab-0b495e2836d9 64024-656 HUMAN OTC DRUG welby day time cold and flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20170919 OTC MONOGRAPH FINAL part341 Aldi Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 64024-766_fbf86cca-7a43-4421-84c7-bd1ec50743b2 64024-766 HUMAN OTC DRUG Welby Infants Acetaminophen Acetaminophen SUSPENSION ORAL 20161216 OTC MONOGRAPH NOT FINAL part343 Aldi Inc ACETAMINOPHEN 160 mg/5mL N 20181231 64024-915_814ceb75-1e79-4beb-b087-ec4ddb23b780 64024-915 HUMAN OTC DRUG welby omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20171004 NDA NDA022032 Aldi Inc OMEPRAZOLE 20 mg/1 N 20181231 64024-959_a465c513-b3a2-4955-8d61-95f43e21029a 64024-959 HUMAN OTC DRUG Antibacterial Chloroxylenol LIQUID TOPICAL 20160429 OTC MONOGRAPH NOT FINAL part333A Aldi, Inc. CHLOROXYLENOL 3.09 mg/mL N 20181231 64024-962_7617df66-e042-48fe-bebe-76e85683e223 64024-962 HUMAN OTC DRUG Foaming Hand Wash Triclosan 0.46% LIQUID TOPICAL 20140213 OTC MONOGRAPH NOT FINAL part333A Aldi, Inc TRICLOSAN .46 mg/mL N 20181231 64024-968_5be1ef4b-7832-4b46-a136-964e87b08f3c 64024-968 HUMAN OTC DRUG LACURA FOR MEN EXTREME BLAST Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20101108 OTC MONOGRAPH FINAL part350 ALDI INC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 200 mg/g E 20171231 64024-969_90a5a5db-3572-4977-bf81-b29e35f7a05b 64024-969 HUMAN OTC DRUG LACURA BODY CARE SHOWER FRESH Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20101108 OTC MONOGRAPH FINAL part350 ALDI INC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 200 mg/g E 20171231 64024-970_602de6c7-b1d8-4a5a-beac-d5083a8ab04d 64024-970 HUMAN OTC DRUG LACURA BODY CARE POWDER FRESH Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20101108 OTC MONOGRAPH FINAL part350 ALDI INC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 200 mg/g E 20171231 64038-059_67469a82-09e3-4671-9776-f72ee54004bf 64038-059 HUMAN PRESCRIPTION DRUG Tramapap Tramadol Hydrochloride, Acetaminophen KIT 20100407 UNAPPROVED DRUG OTHER Living Well Pharmacy, Inc. E 20171231 64038-313_50685541-a4de-4c8a-b0d4-ec14ce0b69da 64038-313 HUMAN PRESCRIPTION DRUG Cyclo/Mag CYCLOBENZAPRINE HYDROCHLORIDE, MAGNESIUM OXIDE KIT 20100309 UNAPPROVED DRUG OTHER Living Well Pharmacy, Inc. E 20171231 64038-630_38c7d64b-ee76-4d72-b3d0-6d05eb5aa2a3 64038-630 HUMAN PRESCRIPTION DRUG Cyclo/Mag 10mg/200mg CYCLOBENZAPRINE HYDROCHLORIDE, MAGNESIUM OXIDE KIT 20100217 UNAPPROVED DRUG OTHER Living Well Pharmacy, Inc. E 20171231 64038-944_8f97fcd2-08db-4b14-95c6-898c22188a2f 64038-944 HUMAN OTC DRUG XOTEN-C Methyl salicylate, Menthol, Capsaicin LOTION TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part348 Living Well Pharmacy Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 10; .002 g/100g; g/100g; g/100g N 20181231 64048-1111_8243fe09-590f-40fd-8ff7-cb266e80e924 64048-1111 HUMAN OTC DRUG Chiggerex 2X Medicated Benzocaine 10.0% OINTMENT TOPICAL 20130218 OTC MONOGRAPH NOT FINAL part348 Product Quest Mfg BENZOCAINE 10 g/100g N 20181231 64048-2171_225f269f-3296-41f0-beb9-70cc72103dbf 64048-2171 HUMAN OTC DRUG Patch Scherer Labs Menthol PATCH TOPICAL 20141023 OTC MONOGRAPH NOT FINAL part348 Product Quest Mfg MENTHOL 5 g/1001 N 20181231 64048-2479_6f777ddc-82fa-45b8-82e4-fbda74c4339f 64048-2479 HUMAN OTC DRUG Joch Itch Antifungal Quinsana Tolnaftate POWDER TOPICAL 20150615 OTC MONOGRAPH FINAL part333C Product Quest Mfg TOLNAFTATE 1 g/100g N 20181231 64048-2480_129c84a7-0bfa-4da2-b436-0742da50801f 64048-2480 HUMAN OTC DRUG Athletes Foot Quinsana Tolnaftate POWDER TOPICAL 20150615 OTC MONOGRAPH FINAL part333C Product Quest Mfg TOLNAFTATE 1 g/100g N 20181231 64048-5000_432dfe52-2ff8-45d3-89d6-628881ebe5a7 64048-5000 HUMAN OTC DRUG Nasal Decongestant Rhinall PHENYLEPHRINE HYDROCHLORIDE 0.25 SPRAY TOPICAL 20100115 OTC MONOGRAPH FINAL part341 Product Quest Mfg. PHENYLEPHRINE HYDROCHLORIDE .25 g/100mL N 20181231 64048-5001_09b8d6b5-f7d7-40c4-9f99-ee4c1f63c8c8 64048-5001 HUMAN OTC DRUG Nasal Decongestant Rhinall PHENYLEPHRINE HYDROCHLORIDE 0.25 SOLUTION/ DROPS TOPICAL 20100115 OTC MONOGRAPH FINAL part341 Product Quest Mfg. PHENYLEPHRINE HYDROCHLORIDE .25 g/100mL N 20181231 64048-7336_e661b737-f1b6-4717-b3bf-dabecfdbfeda 64048-7336 HUMAN OTC DRUG Bite relief Scherer Labs Benzocaine - 5.00% CREAM TOPICAL 20120210 OTC MONOGRAPH NOT FINAL part348 Product Quest Mfg. BENZOCAINE 5 g/100mL N 20181231 64058-113_d938988c-0db3-4863-82c8-61bf06606fac 64058-113 HUMAN OTC DRUG Moisturizing Glucosamine Brand Capsaicin GEL TOPICAL 20100616 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories CAPSAICIN .02125 g/85g N 20181231 64058-116_385b3cdc-56c0-4cea-982e-609a9c0049ce 64058-116 HUMAN OTC DRUG Pure Valley Miracle Age Spot HYDROQUINONE LOTION TOPICAL 20021001 OTC MONOGRAPH NOT FINAL part358A Concept Laboratories, Inc. HYDROQUINONE .015 g/g N 20181231 64058-117_02b9d56a-ce1b-460b-8bd1-8e518a3a5484 64058-117 HUMAN OTC DRUG Painazin CP Capsaicin SPRAY TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .00025 g/mL N 20181231 64058-118_4e46efaf-2928-410f-bf14-31517a6cea19 64058-118 HUMAN OTC DRUG Pure Relief Penetrating Pain Relief Capsaicin GEL TOPICAL 20131206 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .0295 g/118mL N 20181231 64058-145_93157852-e6e9-417a-9844-d8e23328f08f 64058-145 HUMAN OTC DRUG Miracle Plus Diabetic Homeopathic Nerve Pain Reliever ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF, and CLAVICEPS PURPUREA SCLEROTIUM LIQUID TOPICAL 20100210 UNAPPROVED HOMEOPATHIC Concept Laboratories, Inc. ACONITUM NAPELLUS; HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM 12; 12; 12; 12; 12; 12 [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL N 20181231 64058-151_5a7ef586-d0ee-478f-8d69-7c8ff0b2cc23 64058-151 HUMAN OTC DRUG Miracle Plus Homeopathic Skin Tag Remover THUJA OCCIDENTALIS LEAFY TWIG LIQUID TOPICAL 20141103 UNAPPROVED HOMEOPATHIC Concept Laboratories, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/10mL N 20181231 64058-154_107a3124-8cd1-4428-8e1d-e44f773d2d2b 64058-154 HUMAN OTC DRUG Charley Horse ARNICA MONTANA, CUPRIC ARSENITE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and TOXICODENDRON PUBESCENS LEAF CREAM TOPICAL 20140429 UNAPPROVED HOMEOPATHIC Concept Laboratories, Inc. ARNICA MONTANA; CUPRIC ARSENITE; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 4; 8; 8; 8; 4 [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g N 20181231 64058-155_a56b263a-5d26-44fe-a476-4fc6ef6d3913 64058-155 HUMAN OTC DRUG Miracle Plus Overnight Pain Relieving Capsaicin GEL TOPICAL 20141120 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .02825 g/113g N 20181231 64058-159_f1023b8f-af48-4839-892a-4729295712a6 64058-159 HUMAN OTC DRUG Charley Horse ARNICA MONTANA, CUPRIC ARSENITE, COPPER, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, and TOXICODENDRON PUBESCENS LEAF CREAM TOPICAL 20160129 UNAPPROVED HOMEOPATHIC Concept Laboratories, Inc. ARNICA MONTANA; CUPRIC ARSENITE; COPPER; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 4; 10; 11; 10; 4 [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g N 20181231 64058-211_ffc3a9b1-1c1a-4dab-8b31-167092cd09ec 64058-211 HUMAN OTC DRUG PsoCleer Advanced Psoriasis Salicylic Acid CREAM TOPICAL 20100108 OTC MONOGRAPH FINAL part358H Concept Laboratories, Inc. SALICYLIC ACID 2.26 g/113g N 20181231 64058-213_56de92ae-0d11-4694-a6a9-fc99ece6ba82 64058-213 HUMAN OTC DRUG Fast Arthritis Aid Capsicum Oleoresin GEL TOPICAL 20150417 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSICUM OLEORESIN .061 g/244g N 20181231 64058-241_d345f290-cb01-4606-a576-173e125f349c 64058-241 HUMAN OTC DRUG Retadolor Penetrating Cool Therapy Menthol and Camphor (Synthetic) CREAM TOPICAL 20090727 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. MENTHOL; CAMPHOR (SYNTHETIC) 10.2; 5.1 g/85g; g/85g N 20181231 64058-246_01fe64fb-6bbc-4b21-a874-1edb73d7d1b2 64058-246 HUMAN OTC DRUG HURT BLOCKER PRO Pain Relief Capsaicin CREAM TOPICAL 20150512 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .25 mg/g N 20181231 64058-341_496b8ced-0ca7-4589-aa44-f23b887fa812 64058-341 HUMAN OTC DRUG Triple Power Pain Relief MENTHOL, UNSPECIFIED FORM and CAMPHOR (SYNTHETIC) CREAM TOPICAL 20150625 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC) .12; .06 g/g; g/g N 20181231 64058-344_88fcb30a-3f16-46f8-a8d1-f6949a8e0425 64058-344 HUMAN OTC DRUG BioMega Cold Pain Therapy MENTHOL, UNSPECIFIED FORM and CAMPHOR (SYNTHETIC) CREAM TOPICAL 20160107 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC) .12; .06 g/g; g/g N 20181231 64058-345_fc963a5a-6c62-43e6-8b38-e60d90727d33 64058-345 HUMAN OTC DRUG My Omega 3 Rub MENTHOL, UNSPECIFIED FORM and CAMPHOR (SYNTHETIC) CREAM TOPICAL 20160627 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC) .12; .06 g/g; g/g N 20181231 64058-352_8203eba8-962e-4e63-b4d0-922375dbe6b6 64058-352 HUMAN OTC DRUG Hurt Blocker Pro Capsaicin CREAM TOPICAL 20170508 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .025 ug/mL N 20181231 64058-353_5b1a1f09-e365-4e7a-bec8-05a2fcb17f5e 64058-353 HUMAN OTC DRUG Omega 3 Capsaicin CREAM TOPICAL 20160708 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN 2.5 mg/g N 20181231 64058-354_f03f6245-da64-42ce-bc38-8cc774990b6a 64058-354 HUMAN OTC DRUG Omega 3 Capsaicin CREAM TOPICAL 20160708 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN 2.5 mg/g N 20181231 64058-355_dcbfe18e-004d-460c-aa24-e52f73d4f1c7 64058-355 HUMAN OTC DRUG BioMega Capsaicin CREAM TOPICAL 20160831 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN 2.5 mg/g N 20181231 64058-356_d066a7d8-a096-4707-9f10-7efc3e97c96c 64058-356 HUMAN OTC DRUG Pure Relief Capsaicin CREAM TOPICAL 20161206 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN 2.5 mg/g N 20181231 64058-358_def7c73b-b0d4-4950-80ef-c58d8965a12d 64058-358 HUMAN OTC DRUG Omega 3 Capsaicin CREAM TOPICAL 20161116 OTC MONOGRAPH NOT FINAL part348 Concept Laboratories, Inc. CAPSAICIN .025 ug/mL N 20181231 64058-413_a12868b0-0929-46bf-ba12-a2c531c184a0 64058-413 HUMAN OTC DRUG Fast Arthritis Aid Pain Relieving Capsaicin GEL TOPICAL 20110805 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAPSAICIN .01425 g/57g N 20181231 64058-613_734a66a0-e35d-42da-9823-25923280afec 64058-613 HUMAN OTC DRUG Sherman and Clark Pain Relieving Capsaicin GEL TOPICAL 20111206 OTC MONOGRAPH FINAL part348 Concept Laboratories, Inc. CAPSAICIN .06275 g/251mL N 20181231 64058-716_21898acb-0660-482f-866a-fa1bea00c8d5 64058-716 HUMAN OTC DRUG Miracle Fade HYDROQUINONE CREAM TOPICAL 20140429 OTC MONOGRAPH NOT FINAL part358A Concept Laboratories, Inc. HYDROQUINONE 1.695 g/113g N 20181231 64064-0002_1e075a8b-8426-4064-a07d-00c793b5ae45 64064-0002 HUMAN OTC DRUG CliniShield Instant Hand Sanitizer Fragrance Free ethanol GEL TOPICAL 20110215 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 70 mL/100mL E 20171231 64064-002_0321e60d-e053-4583-a789-bd0dc58ccb13 64064-002 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 62 mL/100mL E 20171231 64064-002_193c7816-d76c-4e53-b133-85e49ecbb558 64064-002 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 62 mL/100mL E 20171231 64064-002_71452250-be6e-41c2-bb6b-cd9ee3103b67 64064-002 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 62 mL/100mL E 20171231 64064-002_bff82b2d-eb7b-4d96-9c00-3d53f1892292 64064-002 HUMAN OTC DRUG Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 62 mL/100mL E 20171231 64064-003_97384b49-a61b-4529-a306-b6e49daede56 64064-003 HUMAN OTC DRUG Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110906 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 70 mL/100mL E 20171231 64064-007_12b97e8f-db59-466e-9a68-76b41ef486c3 64064-007 HUMAN OTC DRUG Health Care Personnel Handwash Alcohol LIQUID TOPICAL 20110909 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC TRICLOSAN 1 mL/100mL E 20171231 64064-050_9319d10f-d283-4e30-830d-1f76abafed50 64064-050 HUMAN OTC DRUG Refresh Foaming Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 68 mL/100mL E 20171231 64064-050_ad02b319-4b1c-49e1-9c76-44ed35e21c78 64064-050 HUMAN OTC DRUG Refresh Foaming Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 68 mL/100mL E 20171231 64064-050_bb35699e-d72a-4169-a8aa-3062b1bcce57 64064-050 HUMAN OTC DRUG Refresh Foaming Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC ALCOHOL 68 mL/100mL E 20171231 64064-101_1191f5ad-3451-41fd-849f-83a097ba7271 64064-101 HUMAN OTC DRUG Stoko Refresh Triclosan LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC TRICLOSAN .5 g/100mL E 20171231 64064-105_5a7abb6c-7751-4970-a561-42d5bcc5d863 64064-105 HUMAN OTC DRUG Stoko Refresh Food Handler Foam Triclosan LIQUID TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333A Evonik Stockhausen, LLC TRICLOSAN .5 g/100mL E 20171231 64067-216_801099d9-7e08-446b-ad87-f9526980aa65 64067-216 HUMAN PRESCRIPTION DRUG UVADEX Methoxsalen INJECTION, SOLUTION EXTRACORPOREAL 19990225 NDA NDA020969 Therakos, Inc. METHOXSALEN 20 ug/mL Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient] N 20191231 64068-402_50ea48c0-d256-02bd-e054-00144ff88e88 64068-402 HUMAN OTC DRUG Endit Zinc Oxide Skin Protectant ZINC OXIDE OINTMENT TOPICAL 20170531 OTC MONOGRAPH FINAL part347 Endit Laboratories, Inc. ZINC OXIDE 20 g/100g N 20181231 64069-4111_d23be790-520d-4f07-bcaf-5e3b7c2f22f7 64069-4111 HUMAN PRESCRIPTION DRUG Oxygen, Compressed U.S.P. Oxygen, Compressed U.S.P. GAS RESPIRATORY (INHALATION) 20100610 NDA NDA205865 Techgas Inc. OXYGEN 1 L/L N 20181231 64092-010_a530111f-5415-4e5c-b83e-0e45e9ba4cc0 64092-010 HUMAN OTC DRUG Somnitabs Diphenhydramine HCl TABLET ORAL 19921225 OTC MONOGRAPH FINAL part338 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 64092-012_451c7f5b-1cd8-4c4f-b88e-3160c9131de5 64092-012 HUMAN OTC DRUG Rest Simply Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 64092-020_196e2323-5b75-424c-bca2-233e69bec5f0 64092-020 HUMAN OTC DRUG Stay Awake Maximum Strength Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. CAFFEINE 200 mg/1 N 20181231 64092-031_8f9cc9e9-5e08-49fe-bed2-c0abb480e805 64092-031 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050203 20201128 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ACETAMINOPHEN 80 mg/1 N 20191231 64092-105_6c6a52fc-86bf-4c04-9199-23e11cbe8899 64092-105 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 64092-108_e5e62bc4-70f0-455d-a5cf-142e2b80deae 64092-108 HUMAN OTC DRUG HEALTHCARE Instant Hand Sanitizer Vanilla Scent ALCOHOL LIQUID TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part333E GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ALCOHOL 62 mL/100mL E 20171231 64092-109_8d0218ed-5fba-4d57-966c-72ddf844f494 64092-109 HUMAN OTC DRUG HEALTHCARE Instant Hand Sanitizer Strawberry Scent ALCOHOL LIQUID TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part333E GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ALCOHOL 62 mL/100mL E 20171231 64092-110_33eb2046-08d5-4860-b9d0-0da4efcbe765 64092-110 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ASPIRIN 325 mg/1 N 20181231 64092-112_add0add4-5584-4da5-9a19-ad874b13aa24 64092-112 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 64092-113_a7c898e5-3fbb-4d9b-8f19-c910810aeb2c 64092-113 HUMAN OTC DRUG Health Care Instant Hand Sanitizer Ice Clear ALCOHOL LIQUID TOPICAL 20120328 OTC MONOGRAPH FINAL part333E GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ALCOHOL 62 mL/100mL E 20171231 64092-115_1ae7694d-19fd-447e-8cd1-b9c50405106d 64092-115 HUMAN OTC DRUG Natural Vegetable Laxative Sennosides TABLET, FILM COATED ORAL 19950127 OTC MONOGRAPH NOT FINAL part334 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. SENNOSIDES 8.6 mg/1 N 20181231 64092-119_006b1b3a-4792-46f2-a8ae-1d08258d371e 64092-119 HUMAN OTC DRUG Aspirin Adult Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ASPIRIN 81 mg/1 N 20181231 64092-120_1901ef63-d19c-4793-9ce7-c1ef90fa4a68 64092-120 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20000901 20181214 OTC MONOGRAPH NOT FINAL part334 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. BISACODYL 5 mg/1 E 20171231 64092-121_a287e50b-f4fb-46b4-aeaa-8ce4c77ada36 64092-121 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. BISACODYL 5 mg/1 N 20181231 64092-122_d493b874-9323-4e9e-91ac-ae56b4b32f6e 64092-122 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 64092-141_d3d4ec08-4a1b-4106-bdb1-033c30ab0966 64092-141 HUMAN OTC DRUG Enteric Aspirin Aspirin TABLET, COATED ORAL 19921214 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ASPIRIN 325 mg/1 N 20181231 64092-150_fab02bf5-36f0-47b6-9518-4f5f7b005a84 64092-150 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 19900912 OTC MONOGRAPH NOT FINAL part343 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ASPIRIN 81 mg/1 N 20181231 64092-200_bb0f65a9-a899-4566-b76b-2a7475ca27fb 64092-200 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. IBUPROFEN 200 mg/1 N 20181231 64092-204_2e8e8051-ce9a-41da-9ae9-a997327d0676 64092-204 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. IBUPROFEN 200 mg/1 N 20181231 64092-208_39596916-d5e0-49d6-e054-00144ff8d46c 64092-208 HUMAN OTC DRUG antiperspirant Invisible Powder Fresh aluminum chlorohydrate STICK TOPICAL 20160630 OTC MONOGRAPH FINAL part350 Great Lakes Wholesale, Marketing and Sales, Inc ALUMINUM CHLOROHYDRATE 11.4 1/57g N 20181231 64092-209_3b4b263a-09fb-34a8-e054-00144ff88e88 64092-209 HUMAN OTC DRUG skin protectant petrolatum LOTION TOPICAL 20160630 OTC MONOGRAPH FINAL part347 Great Lakes Wholesale, Marketing and Sales, Inc PETROLATUM 39.9 g/133mL N 20181231 64092-254_3b4bf826-51e8-4d71-e054-00144ff8d46c 64092-254 HUMAN OTC DRUG skin protectant Cocoa Butter petrolatum LOTION TOPICAL 20160630 OTC MONOGRAPH FINAL part347 Great Lakes Wholesale Marketing and Sales, Inc PETROLATUM 39.9 g/133mL N 20181231 64092-267_399387e1-a5d3-5d0e-e054-00144ff88e88 64092-267 HUMAN OTC DRUG antiperspirant aluminum chlorohydrate STICK TOPICAL 20160630 OTC MONOGRAPH FINAL part350 Great Lakes Wholesale, Marketing and Sales, Inc. ALUMINUM CHLOROHYDRATE 11.4 1/57g N 20181231 64092-300_3b3d2213-1e82-4d96-e054-00144ff88e88 64092-300 HUMAN OTC DRUG Hand Wash Original Benzalkonium Chloride LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333A Great Lakes Wholesale, Marketing, and Sales, Inc BENZALKONIUM CHLORIDE .222 g/222mL N 20181231 64092-307_3b4b86f9-eb70-532e-e054-00144ff88e88 64092-307 HUMAN OTC DRUG skin protectant Alcohol LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333A Great Lakes Wholesale, Marketing, and Sales, Inc ALCOHOL 74.4 mL/120mL N 20181231 64092-309_437da7c8-ad32-4925-e054-00144ff88e88 64092-309 HUMAN OTC DRUG health care personnel handwash Berry Chloroxylenol LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333A Great Lakes Wholesale, Marketing, and Sales, Inc. CHLOROXYLENOL .663 g/221mL N 20181231 64092-312_4f1b2435-8b85-4277-8d30-e6786eaaf143 64092-312 HUMAN OTC DRUG Instant Hand Sanitizer Aloe Vera Ethyl Alcohol GEL TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC ALCOHOL 146 mL/236mL N 20181231 64092-313_72a597ac-a286-4922-9367-cf55750547a1 64092-313 HUMAN OTC DRUG Instant Hand Sanitizer - Ice Clear Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC ALCOHOL 37 mL/60mL N 20181231 64092-314_552eb511-4126-479d-ba44-f77839e7f1dd 64092-314 HUMAN OTC DRUG Instant Hand Sanitizer - Clear Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC ALCOHOL 147 mL/237mL N 20181231 64092-315_b577ddec-a10d-4f76-be71-fcf2344e67bd 64092-315 HUMAN OTC DRUG Instant Hand Sanitizer - Cocoa Butter Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC ALCOHOL 147 mL/237mL N 20181231 64092-316_629dd3c1-50e2-4cae-b675-97e504096e60 64092-316 HUMAN OTC DRUG Liquid Hand Cleanse Triclosan GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC TRICLOSAN 10 mg/500mg N 20181231 64092-317_b2ce150f-c8b0-4c78-b6c9-37b02169710e 64092-317 HUMAN OTC DRUG Instant Hand Sanitizer - Original Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC ALCOHOL 33 mL/53mL N 20181231 64092-318_e796fd20-b92e-4eeb-8102-21e7dfdb2dce 64092-318 HUMAN OTC DRUG Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333E Great Lakes Wholesale & Marketing, LLC ALCOHOL 6 mL/10mL N 20181231 64092-321_3b4b9696-8671-54a9-e054-00144ff88e88 64092-321 HUMAN OTC DRUG skin protectant Original alcohol LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333E Great lakes Wholesale, Marketing, and Sales, Inc. ALCOHOL 146.94 mL/237mL N 20181231 64092-323_437da7c8-ad32-4925-e054-00144ff88e88 64092-323 HUMAN OTC DRUG health care personnel handwash Peach Chloroxylenol LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333A Great Lakes Wholesale, Marketing, and Sales, Inc. CHLOROXYLENOL .663 g/221mL N 20181231 64092-324_3b3d2213-1e82-4d96-e054-00144ff88e88 64092-324 HUMAN OTC DRUG Hand Wash Pear Benzalkonium Chloride LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333A Great Lakes Wholesale, Marketing, and Sales, Inc BENZALKONIUM CHLORIDE .222 g/222mL N 20181231 64092-325_3b4b7de4-4453-4d87-e054-00144ff88e88 64092-325 HUMAN OTC DRUG Acne salicylic acid LIQUID TOPICAL 20160630 OTC MONOGRAPH FINAL part333D Great Lakes Wholesale, Marketing and Sales Inc SALICYLIC ACID 1.2 g/240mL N 20181231 64092-345_3b4b9696-8671-54a9-e054-00144ff88e88 64092-345 HUMAN OTC DRUG skin protectant Aloe Vera alcohol LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333E Great lakes Wholesale, Marketing, and Sales, Inc. ALCOHOL 146.94 mL/237mL N 20181231 64092-347_437da7c8-ad32-4925-e054-00144ff88e88 64092-347 HUMAN OTC DRUG health care personnel handwash Fresh Melon Chloroxylenol LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333A Great Lakes Wholesale, Marketing, and Sales, Inc. CHLOROXYLENOL .663 g/221mL N 20181231 64092-348_3b3d2213-1e82-4d96-e054-00144ff88e88 64092-348 HUMAN OTC DRUG Hand Wash Lemon Benzalkonium Chloride LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333A Great Lakes Wholesale, Marketing, and Sales, Inc BENZALKONIUM CHLORIDE .222 g/222mL N 20181231 64092-350_42dcd95d-d16d-4635-960b-fb85840dacf8 64092-350 HUMAN OTC DRUG Nighttime Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 64092-361_437da7c8-ad32-4925-e054-00144ff88e88 64092-361 HUMAN OTC DRUG health care personnel handwash Strawberry Chloroxylenol LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333A Great Lakes Wholesale, Marketing, and Sales, Inc. CHLOROXYLENOL .663 g/221mL N 20181231 64092-362_3b3d2213-1e82-4d96-e054-00144ff88e88 64092-362 HUMAN OTC DRUG Hand wash Strawberry benzalkonium chloride LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333A Great Lakes Wholesale, Marketing, and Sales, Inc BENZALKONIUM CHLORIDE .222 g/222mL N 20181231 64092-369_3b4b9696-8671-54a9-e054-00144ff88e88 64092-369 HUMAN OTC DRUG skin protectant Lavender alcohol LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333E Great lakes Wholesale, Marketing, and Sales, Inc. ALCOHOL 146.94 mL/237mL N 20181231 64092-383_3b4b9696-8671-54a9-e054-00144ff88e88 64092-383 HUMAN OTC DRUG skin protectant Sweet Pea alcohol LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333E Great lakes Wholesale, Marketing, and Sales, Inc. ALCOHOL 146.94 mL/237mL N 20181231 64092-385_437da7c8-ad32-4925-e054-00144ff88e88 64092-385 HUMAN OTC DRUG health care personnel handwash Aloe Vera Chloroxylenol LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333A Great Lakes Wholesale, Marketing, and Sales, Inc. CHLOROXYLENOL .663 g/221mL N 20181231 64092-386_437da7c8-ad32-4925-e054-00144ff88e88 64092-386 HUMAN OTC DRUG health care personnel handwash Lavender Chloroxylenol LIQUID TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part333A Great Lakes Wholesale, Marketing, and Sales, Inc. CHLOROXYLENOL .663 g/221mL N 20181231 64092-402_42eef404-1d3b-5991-e054-00144ff8d46c 64092-402 HUMAN OTC DRUG Pain Relief Liquid Menthol LIQUID TOPICAL 20161205 OTC MONOGRAPH NOT FINAL part348 Great Lakes Wholesale, Marking, and Sales, Inc. MENTHOL .16 g/mL E 20171231 64092-403_39573c12-c132-10cb-e054-00144ff88e88 64092-403 HUMAN OTC DRUG nasal decongestant Menthol, camphor,eucalyptus oil GEL TOPICAL 20160630 OTC MONOGRAPH FINAL part341 Great Lakes Wholesale, Marketing, and Sales, INC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 5.17; 1.1; 1.1 1/110g; 1/110g; 1/110g N 20181231 64092-406_42f0def9-5da4-4677-e054-00144ff8d46c 64092-406 HUMAN OTC DRUG Liquid Bandage Benzethonium Chloride LIQUID TOPICAL 20161205 OTC MONOGRAPH NOT FINAL part333A Great Lakes Wholesale, Marketing, and Sales, Inc BENZETHONIUM CHLORIDE .02 g/10mL E 20171231 64092-413_5d8de051-d40c-7de3-e053-2991aa0a7fad 64092-413 HUMAN OTC DRUG Health Care Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 Great Lakes Wholesale, Marketing and Sales Inc ZINC OXIDE 160 mg/mL N 20181231 64092-506_42f0f24c-97e1-4a3d-e054-00144ff8d46c 64092-506 HUMAN OTC DRUG Pain Relief Sleeve Medium Menthol PATCH TOPICAL 20161205 OTC MONOGRAPH NOT FINAL part348 Great Lakes Wholesale, Marketing, and Sales, Inc MENTHOL 160 mg/mL E 20171231 64092-520_42f0f24c-97e1-4a3d-e054-00144ff8d46c 64092-520 HUMAN OTC DRUG Pain Relief Sleeve Large Menthol PATCH TOPICAL 20161205 OTC MONOGRAPH NOT FINAL part348 Great Lakes Wholesale, Marketing, and Sales, Inc MENTHOL 160 mg/mL E 20171231 64092-544_42f0f24c-97e1-4a3d-e054-00144ff8d46c 64092-544 HUMAN OTC DRUG Pain Relief Sleeve Extra Large Menthol PATCH TOPICAL 20161205 OTC MONOGRAPH NOT FINAL part348 Great Lakes Wholesale, Marketing, and Sales, Inc MENTHOL 160 mg/mL E 20171231 64092-600_d6af3eff-eb38-41fe-9246-b955471e878e 64092-600 HUMAN OTC DRUG Motion Sickness Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. DIMENHYDRINATE 50 mg/1 N 20181231 64092-608_4f5c1e01-f596-40cf-8b60-a13aaef649a7 64092-608 HUMAN OTC DRUG Motion Sickness II Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 64092-802_ab711021-83ee-4173-b303-bcba134e768a 64092-802 HUMAN OTC DRUG Suphedrine PE Phenylephrine HCl TABLET, FILM COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 64092-820_670209ef-f594-4767-a045-c0390066862e 64092-820 HUMAN OTC DRUG Chlor-Allergy 4-Hour Chlorpheniramine Maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20191231 64092-830_da406d03-1d70-4c09-bdae-5e81d0f2346a 64092-830 HUMAN OTC DRUG Complete Allergy Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 64092-835_1dc1acff-f464-4ab8-abd6-932d39f07fd6 64092-835 HUMAN OTC DRUG Allerfed Cold and Allergy Chlorpheniramine maleate and Phenylephrine HCl TABLET ORAL 20020722 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 64092-845_0065f0ab-0545-448f-aafe-d9e1f4f76e53 64092-845 HUMAN OTC DRUG Non-Drowsy Sinus Daytime Acetaminophen and Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 64092-865_74673134-cb3d-4069-a37b-b9354e310f05 64092-865 HUMAN OTC DRUG Complete Allergy and Sinus Multi Symptom Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl TABLET, FILM COATED ORAL 20060530 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 64092-870_7bf06ff6-9e02-47b5-9b8b-927ce8dc956d 64092-870 HUMAN OTC DRUG Multi-Symptom Cold Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET ORAL 20050715 OTC MONOGRAPH FINAL part341 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 64097-0001_8def91d4-8ccf-457f-96c5-f643130ca8a5 64097-0001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Alternacare Home Health Services OXYGEN 99.5 L/100L N 20181231 64108-212_8c08a421-0e2e-4acb-a3d6-ae439a28597c 64108-212 HUMAN OTC DRUG MiniDrops Lubricant eye drops LIQUID OPHTHALMIC 19910401 OTC MONOGRAPH FINAL part349 Optics Laboratory, Inc POVIDONE K30; POLYVINYL ALCOHOL .6; 1.4 mL/100mL; mL/100mL N 20181231 64108-313_1a941a0d-f769-49e3-bf0b-60f0ae1da5ba 64108-313 HUMAN OTC DRUG OCUFRESH Water LIQUID OPHTHALMIC 20140115 OTC MONOGRAPH FINAL part349 Optics Laboratory Inc. WATER .988 mL/mL N 20181231 64116-121_58cc9885-2828-435d-9db2-8e94cdecfa00 64116-121 HUMAN PRESCRIPTION DRUG Esbriet pirfenidone CAPSULE ORAL 20141016 NDA NDA022535 InterMune, Inc. PIRFENIDONE 267 mg/1 Pyridone [EPC],Pyridones [Chemical/Ingredient] N 20181231 64117-052_681e9d88-433b-4cad-abc5-433c3520647e 64117-052 HUMAN OTC DRUG NEURALGIA HEADACHE ZINC PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ZINC 30 [hp_C]/mL N 20181231 64117-100_c5fb97a1-da63-471d-98be-87f8d1915a10 64117-100 HUMAN OTC DRUG Indigestion ARTEMISIA ABROTANUM FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARTEMISIA ABROTANUM FLOWERING TOP 30 [hp_C]/mL N 20181231 64117-101_2157f54d-1c49-487c-861b-693b4eb34630 64117-101 HUMAN OTC DRUG Rheumatism ACTAEA SPICATA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ACTAEA SPICATA ROOT 30 [hp_C]/mL N 20181231 64117-102_3a0658f7-b48f-4f24-a33b-9b9d379aa2db 64117-102 HUMAN OTC DRUG Vomiting Diarrhea AETHUSA CYNAPIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AETHUSA CYNAPIUM 30 [hp_C]/mL N 20181231 64117-103_ce7a8cfc-c459-4508-afef-1828a7400dda 64117-103 HUMAN OTC DRUG Sprains Strains CHASTE TREE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CHASTE TREE 30 [hp_C]/mL N 20181231 64117-104_f64df010-caa6-4f2f-91c4-e89472285e87 64117-104 HUMAN OTC DRUG Skin Rash Acne AILANTHUS ALTISSIMA FLOWERING TWIG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AILANTHUS ALTISSIMA FLOWERING TWIG 30 [hp_C]/mL N 20181231 64117-105_52c65d8d-bcf2-46bf-a700-95fcf0ed1416 64117-105 HUMAN OTC DRUG Nervous Cough AMBERGRIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AMBERGRIS 30 [hp_C]/mL N 20181231 64117-106_b47d136e-83a4-4755-980a-66765f6b7516 64117-106 HUMAN OTC DRUG Hoarse Cough AMMONIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AMMONIUM CATION 30 [hp_C]/mL N 20181231 64117-107_fb86fdd9-ecc6-4ad4-884a-c78eda387bdb 64117-107 HUMAN OTC DRUG Rheumatism ANGOSTURA BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ANGOSTURA BARK 30 [hp_C]/mL N 20181231 64117-108_1ff290be-911f-41fe-97b2-9fc74dfb5735 64117-108 HUMAN OTC DRUG Headache Cough ARSENIC TRIIODIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARSENIC TRIIODIDE 30 [hp_C]/mL N 20181231 64117-109_f3ff8ed0-4f07-4b7f-808f-3c1ea9016d2d 64117-109 HUMAN OTC DRUG Burning Runny Nose ARISAEMA TRIPHYLLUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARISAEMA TRIPHYLLUM ROOT 30 [hp_C]/mL N 20181231 64117-110_e090f79d-a90c-464d-aafb-d69152a9c75f 64117-110 HUMAN OTC DRUG Flatulence ASAFETIDA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ASAFETIDA 30 [hp_C]/mL N 20181231 64117-111_823ebed5-b8ac-4960-8a60-24a2bfe78b27 64117-111 HUMAN OTC DRUG Nervous Headache ASARUM EUROPAEUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ASARUM EUROPAEUM 30 [hp_C]/mL N 20181231 64117-112_c8a77e5b-729f-45d4-9f2b-b3c6f9216f50 64117-112 HUMAN OTC DRUG Acne ASTERIAS RUBENS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ASTERIAS RUBENS 30 [hp_C]/mL N 20181231 64117-113_7465805c-dac0-48db-81b4-605905424276 64117-113 HUMAN OTC DRUG Slow Digestion Diarrhea GOLD TRICHLORIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GOLD TRICHLORIDE 30 [hp_C]/mL N 20181231 64117-114_68bb8dfb-84f6-4c86-92a8-35bbc499dbf0 64117-114 HUMAN OTC DRUG Dyspepsia BARIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BARIUM CATION 30 [hp_C]/mL N 20181231 64117-115_24d51928-1f7f-466c-9585-5ab40c6ee909 64117-115 HUMAN OTC DRUG Rheumatism Diarrhea BENZOIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BENZOIC ACID 30 [hp_C]/mL N 20181231 64117-116_de88e126-296b-47d6-8a77-d792edc51246 64117-116 HUMAN OTC DRUG Colitis BISMUTH PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BISMUTH 30 [hp_C]/mL N 20181231 64117-117_81fc51d5-c36b-48f9-ad3b-0af04f220353 64117-117 HUMAN OTC DRUG Cough BLATTA ORIENTALIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BLATTA ORIENTALIS 30 [hp_C]/mL N 20181231 64117-118_414258a1-b325-493b-9f44-218e8b8609e1 64117-118 HUMAN OTC DRUG Dry Cough Diarrhea SODIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM CATION 30 [hp_C]/mL N 20181231 64117-119_4a2cc23b-a529-43b0-888d-67785aa7d87e 64117-119 HUMAN OTC DRUG Eczema Headache GIANT PUFFBALL PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GIANT PUFFBALL 30 [hp_C]/mL N 20181231 64117-120_6d69125f-442b-4908-8164-51d9f15e9ffd 64117-120 HUMAN OTC DRUG Rheumatic Pains BUFO BUFO CUTANEOUS GLAND PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BUFO BUFO CUTANEOUS GLAND 30 [hp_C]/mL N 20181231 64117-121_39c82341-fcb8-47ad-80cb-c30b2b06eeaf 64117-121 HUMAN OTC DRUG Indigestion CADMIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CADMIUM 30 [hp_C]/mL N 20181231 64117-122_13441ad6-f4e6-4d36-ab69-78fa89bbc496 64117-122 HUMAN OTC DRUG Skin Irritation DIEFFENBACHIA SEGUINE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DIEFFENBACHIA SEGUINE 30 [hp_C]/mL N 20181231 64117-123_e332cd32-d0d5-4c28-b531-9d6bb95407ec 64117-123 HUMAN OTC DRUG Flatulence CALCIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM CATION 30 [hp_C]/mL N 20181231 64117-124_80b479fb-f69a-4095-8937-83a96b27cae9 64117-124 HUMAN OTC DRUG Eczema Skin Eruptions CALCIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM CATION 30 [hp_C]/mL N 20181231 64117-125_6d9e9c97-92cd-4145-8f33-abe279e58e61 64117-125 HUMAN OTC DRUG Common Cold CAMPHOR (NATURAL) PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CAMPHOR (NATURAL) 30 [hp_C]/mL N 20181231 64117-126_6575fb79-ae4a-490c-ac6e-3b2e89cc9a07 64117-126 HUMAN OTC DRUG Sore Throat headache CAPSICUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CAPSICUM 30 [hp_C]/mL N 20181231 64117-127_51e9c972-a35a-47d5-b5ac-951d317cd6a8 64117-127 HUMAN OTC DRUG Flatulence CARBO ANIMALIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CARBO ANIMALIS 30 [hp_C]/mL N 20181231 64117-128_8ea367e7-8141-4248-858b-9fe66002f383 64117-128 HUMAN OTC DRUG Warts EQUUS CABALLUS SKIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply EQUUS CABALLUS SKIN 30 [hp_C]/mL N 20181231 64117-129_2438f7f8-1d25-408d-abc4-49fcc0d9f6a1 64117-129 HUMAN OTC DRUG Diarrhea CEANOTHUS AMERICANUS LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CEANOTHUS AMERICANUS LEAF 30 [hp_C]/mL N 20181231 64117-130_a5aeee17-13f7-4b31-a018-3232153bf0ed 64117-130 HUMAN OTC DRUG Billiousness CHELIDONIUM MAJUS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CHELIDONIUM MAJUS 30 [hp_C]/mL N 20181231 64117-131_9ed03e72-e98c-4677-bb21-ddd4bc7ac7b6 64117-131 HUMAN OTC DRUG Headache CHIONANTHUS VIRGINICUS BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CHIONANTHUS VIRGINICUS BARK 30 [hp_C]/mL N 20181231 64117-132_aebb7f96-0147-4245-a14e-8db774119e9a 64117-132 HUMAN OTC DRUG Skin Eruptions CICUTA VIROSA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CICUTA VIROSA ROOT 30 [hp_C]/mL N 20181231 64117-133_33f796d8-b28d-4f89-a1a6-c338f2009939 64117-133 HUMAN OTC DRUG Skin Eruptions CLEMATIS RECTA FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CLEMATIS RECTA FLOWERING TOP 30 [hp_C]/mL N 20181231 64117-134_535c933a-2708-4a03-8048-87983def939e 64117-134 HUMAN OTC DRUG Skin Eruptions Cough PROTORTONIA CACTI PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PROTORTONIA CACTI 30 [hp_C]/mL N 20181231 64117-135_cbdcfa56-6b52-413d-bac5-20db7b3848b2 64117-135 HUMAN OTC DRUG Rheumatism COLCHICUM AUTUMNALE BULB PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply COLCHICUM AUTUMNALE BULB 30 [hp_C]/mL N 20181231 64117-136_1b018e36-b868-4339-837f-ef6cd78f73f1 64117-136 HUMAN OTC DRUG Nausea Vomiting MARSDENIA CONDURANGO BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MARSDENIA CONDURANGO BARK 30 [hp_C]/mL N 20181231 64117-137_12880526-383b-4e86-a089-2295a6ef5ab9 64117-137 HUMAN OTC DRUG Dysmenorrhea Headache SAFFRON PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SAFFRON 30 [hp_C]/mL N 20181231 64117-138_5a68655c-1239-42a2-a471-a4d801ad601e 64117-138 HUMAN OTC DRUG Diarrhea CROTON OIL PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CROTON OIL 30 [hp_C]/mL N 20181231 64117-139_f69a3431-9bc7-432b-b0f7-529840bb6c24 64117-139 HUMAN OTC DRUG Nausea Headache DIGITALIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DIGITALIS 30 [hp_C]/mL N 20181231 64117-140_1c811d3d-d5d3-4460-bb31-1ad65d0ccdc7 64117-140 HUMAN OTC DRUG Cough Flu SOLANUM DULCAMARA TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SOLANUM DULCAMARA TOP 30 [hp_C]/mL N 20181231 64117-141_169ae6b1-ebdc-46fc-8575-f01fae89ea1f 64117-141 HUMAN OTC DRUG Carbuncles Boils ECHINACEA ANGUSTIFOLIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ECHINACEA ANGUSTIFOLIA 30 [hp_C]/mL N 20181231 64117-142_9cc8950e-ccb6-4190-95e7-df56d5153c05 64117-142 HUMAN OTC DRUG Incontinence EQUISETUM HYEMALE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply EQUISETUM HYEMALE 30 [hp_C]/mL N 20181231 64117-143_09598590-5077-4612-b32d-ff7658c6d276 64117-143 HUMAN OTC DRUG Colds Flu EUPATORIUM PERFOLIATUM FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply EUPATORIUM PERFOLIATUM FLOWERING TOP 30 [hp_C]/mL N 20181231 64117-144_3943b822-6915-4b8e-ba74-80bcfe31a630 64117-144 HUMAN OTC DRUG Nasal Catarrh FORMALDEHYDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FORMALDEHYDE 30 [hp_C]/mL N 20181231 64117-145_63bb3ca5-38a6-4498-9c42-0ad4e6867b36 64117-145 HUMAN OTC DRUG Vomiting Diarrhea PSEUDOGNAPHALIUM OBTUSIFOLIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PSEUDOGNAPHALIUM OBTUSIFOLIUM 30 [hp_C]/mL N 20181231 64117-146_0f3eb74e-5894-4708-b352-134926f7fc5d 64117-146 HUMAN OTC DRUG Nausea GOSSYPIUM HERBACEUM ROOT BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GOSSYPIUM HERBACEUM ROOT BARK 30 [hp_C]/mL N 20181231 64117-147_31fb6a0f-e5ad-43ff-81cf-beb7d0316642 64117-147 HUMAN OTC DRUG Toothache Neuralgia HEKLA LAVA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HEKLA LAVA 30 [hp_C]/mL N 20181231 64117-148_7146bd3b-449d-4b99-879b-b9072dae721c 64117-148 HUMAN OTC DRUG Dry Cough IODINE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply IODINE 30 [hp_C]/mL N 20181231 64117-149_0a4c9220-aeb9-48b7-b4d6-9620e09226fa 64117-149 HUMAN OTC DRUG RHEUMATISM, NAUSEA JACARANDA CAROBA FLOWER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply JACARANDA CAROBA FLOWER 30 [hp_C]/mL N 20181231 64117-150_65e6934d-c244-4858-8d16-bc267bc80e4a 64117-150 HUMAN OTC DRUG Skin Affections POTASSIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL N 20181231 64117-151_44d4af1c-33db-49b7-957b-73196e6d49c2 64117-151 HUMAN OTC DRUG Insomnia POTASSIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL N 20181231 64117-152_cfa77971-5fa8-4d6b-8321-d043747cf8f7 64117-152 HUMAN OTC DRUG Colds Dry Cough Potassium Cation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL N 20181231 64117-153_339f9359-8be4-4761-97a9-9fde1f9d77b7 64117-153 HUMAN OTC DRUG Runny Nose Warts Potassium Cation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL N 20181231 64117-154_4ac9f09c-6b5c-41db-9177-6f0d72cb1aca 64117-154 HUMAN OTC DRUG Headache Nervousness Potassium Cation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL N 20181231 64117-155_0c89aa39-d29b-4fc7-9859-18bc4f21fe3a 64117-155 HUMAN OTC DRUG Sun Headache Rheumatism KALMIA LATIFOLIA LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply KALMIA LATIFOLIA LEAF 30 [hp_C]/mL N 20181231 64117-156_1b1459b3-a4eb-4f1c-9352-c5af66d897ba 64117-156 HUMAN OTC DRUG Tickling Cough LACTUCA VIROSA LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LACTUCA VIROSA LEAF 30 [hp_C]/mL N 20181231 64117-157_9eadee3d-60ed-4ab7-a3ac-c179ef7731cd 64117-157 HUMAN OTC DRUG Heartburn PRUNUS LAUROCERASUS LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PRUNUS LAUROCERASUS LEAF 30 [hp_C]/mL N 20181231 64117-158_392e5bcc-4386-4b0e-beac-7715a6d22c70 64117-158 HUMAN OTC DRUG Cough Hay Fever LOBELIA INFLATA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LOBELIA INFLATA 30 [hp_C]/mL N 20181231 64117-159_74b9dd35-fbbc-4fc2-b760-f14700abc19d 64117-159 HUMAN OTC DRUG Diarrhea Dyspepsia MAGNESIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MAGNESIUM CATION 30 [hp_C]/mL N 20181231 64117-160_9b7650a7-9f8c-4d3d-969f-adcc16545e90 64117-160 HUMAN OTC DRUG Constipation Billousness MAGNESIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MAGNESIUM CATION 30 [hp_C]/mL N 20181231 64117-161_b743000c-f764-475f-9bc3-dd74462bd4ce 64117-161 HUMAN OTC DRUG Headache HIPPOMANE MANCINELLA FRUITING LEAFY TWIG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HIPPOMANE MANCINELLA FRUITING LEAFY TWIG 30 [hp_C]/mL N 20181231 64117-162_3eda8c57-d2db-47f9-bd97-a528093b8bdb 64117-162 HUMAN OTC DRUG Headache Spasms MELILOTUS OFFICINALIS TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MELILOTUS OFFICINALIS TOP 30 [hp_C]/mL N 20181231 64117-163_5b2aa810-a6c2-4045-af8d-f6ac5e750ba9 64117-163 HUMAN OTC DRUG SPASMODIC COUGH MEPHITIS MEPHITIS ANAL GLAND FLUID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MEPHITIS MEPHITIS ANAL GLAND FLUID 30 [hp_C]/mL N 20181231 64117-164_eb8bf9e9-e665-45be-a048-f100a793554d 64117-164 HUMAN OTC DRUG Sore Throat Diarrhea MERCURIC CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MERCURIC CATION 30 [hp_C]/mL N 20181231 64117-165_f75bd644-73fa-4dcf-ab04-fc23b7da2e56 64117-165 HUMAN OTC DRUG Sore Throat Right Side MERCUROUS IODIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MERCUROUS IODIDE 30 [hp_C]/mL N 20181231 64117-166_731a5870-d6a2-4310-b117-af424b273a04 64117-166 HUMAN OTC DRUG Sore Throat Left Side MERCURIC IODIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MERCURIC IODIDE 30 [hp_C]/mL N 20181231 64117-167_8dfd3510-4ab2-4fd4-9d70-c5a4d2405d67 64117-167 HUMAN OTC DRUG SORE THROAT VIROLA SEBIFERA RESIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VIROLA SEBIFERA RESIN 30 [hp_C]/mL N 20181231 64117-168_38b92836-5f72-4f5d-9883-e938302bad23 64117-168 HUMAN OTC DRUG Indigestion Diarrhea NUTMEG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply NUTMEG 30 [hp_C]/mL N 20181231 64117-169_c2b66ec3-82f8-4a4f-a9f3-110bcaf97998 64117-169 HUMAN OTC DRUG Headache ORIGANUM MAJORANA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ORIGANUM MAJORANA 30 [hp_C]/mL N 20181231 64117-170_a8cc9907-aa83-4ae3-9994-dee59c131cc0 64117-170 HUMAN OTC DRUG Constipation PALLADIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PALLADIUM 30 [hp_C]/mL N 20181231 64117-171_62eac367-a3e8-425a-af73-ce4e6693e133 64117-171 HUMAN OTC DRUG Profuse Sweating PILOCARPUS JABORANDI LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PILOCARPUS JABORANDI LEAF 30 [hp_C]/mL N 20181231 64117-172_bdcc8441-86e7-4feb-9f6c-fb67d93cdb59 64117-172 HUMAN OTC DRUG Diarrhea QUERCUS ROBUR NUT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply QUERCUS ROBUR NUT 30 [hp_C]/mL E 20171231 64117-173_cbb878cc-2586-4338-b004-85597a765e80 64117-173 HUMAN OTC DRUG Rheumatism RADIUM BROMIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply RADIUM BROMIDE 30 [hp_C]/mL N 20181231 64117-174_8b78810d-ce99-462b-aeae-0b74ee91928f 64117-174 HUMAN OTC DRUG Hemmorrhoids KRAMERIA LAPPACEA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply KRAMERIA LAPPACEA ROOT 30 [hp_C]/mL N 20181231 64117-175_0424b91c-e4ac-442d-b48a-9ed563c7fa07 64117-175 HUMAN OTC DRUG Diarrhea RHEUM OFFICINALE ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply RHEUM OFFICINALE ROOT 30 [hp_C]/mL N 20181231 64117-176_6a4a76f7-5072-42b9-9524-f6cdc6cfbe5f 64117-176 HUMAN OTC DRUG Hay Fever SCHOENOCAULON OFFICINALE SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SCHOENOCAULON OFFICINALE SEED 30 [hp_C]/mL N 20181231 64117-177_7b739de3-f2d6-4eb5-b882-9c359af06223 64117-177 HUMAN OTC DRUG Painful Urination SAW PALMETTO PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SAW PALMETTO 30 [hp_C]/mL N 20181231 64117-178_5d54f65a-342a-4f26-a954-a3efbdddd671 64117-178 HUMAN OTC DRUG Cough Perspiration SAMBUCUS NIGRA FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SAMBUCUS NIGRA FLOWERING TOP 30 [hp_C]/mL N 20181231 64117-179_cbaddbac-27f1-4381-84a8-9fc4f4d704bf 64117-179 HUMAN OTC DRUG Boils Eczema SARSAPARILLA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SARSAPARILLA ROOT 30 [hp_C]/mL N 20181231 64117-180_6e217959-d70d-4ffb-a315-f9712139acaa 64117-180 HUMAN OTC DRUG Hemmorrhoids SCROPHULARIA NODOSA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SCROPHULARIA NODOSA 30 [hp_C]/mL N 20181231 64117-181_5eb0799c-9abe-429c-b743-4200c9e5d523 64117-181 HUMAN OTC DRUG Headache CLAVICEPS PURPUREA SCLEROTIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CLAVICEPS PURPUREA SCLEROTIUM 30 [hp_C]/mL N 20181231 64117-182_2c265a3a-b361-46c5-8ebb-5615c5d6dcf4 64117-182 HUMAN OTC DRUG Hoarse Cough SELENIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SELENIUM 30 [hp_C]/mL N 20181231 64117-183_ecfe8d25-35ad-4272-a888-58289d1a669a 64117-183 HUMAN OTC DRUG Cough Thick Mucous POLYGALA SENEGA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POLYGALA SENEGA ROOT 30 [hp_C]/mL N 20181231 64117-184_17e7a885-a72f-4c53-8383-01790fa65a9d 64117-184 HUMAN OTC DRUG Hoarse Cough TIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TIN 30 [hp_C]/mL N 20181231 64117-185_b456fa8c-e503-4985-b5be-905a51ac5cbb 64117-185 HUMAN OTC DRUG Cough Colds LOBARIA PULMONARIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LOBARIA PULMONARIA 30 [hp_C]/mL N 20181231 64117-186_bea72c95-6eb6-424a-a8a7-78ed555d52f9 64117-186 HUMAN OTC DRUG Dyspepsia STRONTIUM BROMIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply STRONTIUM BROMIDE 30 [hp_C]/mL N 20181231 64117-187_a87da41d-c780-46b1-aade-ee7721aef51b 64117-187 HUMAN OTC DRUG Indigestion With Nausea STROPHANTHUS HISPIDUS SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply STROPHANTHUS HISPIDUS SEED 30 [hp_C]/mL N 20181231 64117-188_f9252d09-e439-43ff-b6ce-b5c747f4c8ba 64117-188 HUMAN OTC DRUG Acne Skin eruptions SULFUR IODIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SULFUR IODIDE 30 [hp_C]/mL N 20181231 64117-189_128961f6-4bb5-4d16-9b2e-bf471184c1d7 64117-189 HUMAN OTC DRUG Colds Flu SULFURIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SULFURIC ACID 30 [hp_C]/mL N 20181231 64117-190_39ef761f-9a41-4bd2-9396-72d1bcf4527d 64117-190 HUMAN OTC DRUG Gastric Headache TARAXACUM OFFICINALE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TARAXACUM OFFICINALE 30 [hp_C]/mL N 20181231 64117-191_be74d851-4534-4c05-95e6-1c017ce2955f 64117-191 HUMAN OTC DRUG Sore Throat headache TURPENTINE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TURPENTINE 30 [hp_C]/mL N 20181231 64117-192_274a0221-e6fc-4e87-899f-61bb74cfd081 64117-192 HUMAN OTC DRUG NHS Insomnia 4 CAMELLIA SINENSIS FLOWER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CAMELLIA SINENSIS FLOWER 30 [hp_C]/mL N 20181231 64117-193_41368e1b-bf26-4a05-a722-ad7001e15f49 64117-193 HUMAN OTC DRUG Menstrual Headache USTILAGO MAYDIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply USTILAGO MAYDIS 30 [hp_C]/mL N 20181231 64117-194_947a2b52-8bcb-43ea-aaab-42410716fe3c 64117-194 HUMAN OTC DRUG Insomnia Nervousness VALERIAN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VALERIAN 30 [hp_C]/mL N 20181231 64117-195_213184ad-3fec-4e90-a0f2-51463fa78adf 64117-195 HUMAN OTC DRUG Painful Menstruation VIBURNUM OPULUS BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VIBURNUM OPULUS BARK 30 [hp_C]/mL N 20181231 64117-196_3971ee98-01cc-4fbc-9ad1-30f5011ffa33 64117-196 HUMAN OTC DRUG Menopause VIPERA BERUS VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VIPERA BERUS VENOM 30 [hp_C]/mL N 20181231 64117-197_7e1b8350-cfbf-4b17-b2e7-784be24c7fcc 64117-197 HUMAN OTC DRUG Rheumatism Cough VISCUM ALBUM FRUITING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VISCUM ALBUM FRUITING TOP 30 [hp_C]/mL N 20181231 64117-198_d0725efe-f074-4e18-87dd-e72c00bd50b9 64117-198 HUMAN OTC DRUG Sore Throat Dry Cough WYETHIA HELENIOIDES ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply WYETHIA HELENIOIDES ROOT 30 [hp_C]/mL N 20181231 64117-199_83f376af-0be2-4712-8afc-e9aca1b2fdde 64117-199 HUMAN OTC DRUG FATIGUE LACTOSE, X-RAY EXPOSED (1000 RAD) PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LACTOSE, X-RAY EXPOSED (1000 RAD) 30 [hp_C]/mL N 20181231 64117-200_f8d961ec-02b8-4733-872a-ea5c07ed259b 64117-200 HUMAN OTC DRUG DYSPEPSIA 3 PICEA MARIANA RESIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PICEA MARIANA RESIN 30 [hp_C]/mL N 20181231 64117-201_8fcace97-80e3-4426-813f-e2fd1eeefb91 64117-201 HUMAN OTC DRUG NERVOUSNESS EXCITEMENT WORMWOOD PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply WORMWOOD 30 [hp_C]/mL N 20181231 64117-202_8814e8a4-5635-46dd-be0b-bfc6119a9ab1 64117-202 HUMAN OTC DRUG DYSPEPSIA FATIGUE ACETIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ACETIC ACID 30 [hp_C]/mL N 20181231 64117-203_0f883659-9ca2-4c20-bfc8-6fbbd18a2833 64117-203 HUMAN OTC DRUG HAY FEVER 1 AMBROSIA ARTEMISIIFOLIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AMBROSIA ARTEMISIIFOLIA 30 [hp_C]/mL N 20181231 64117-204_b4129b37-6d0c-496b-8869-adbb87b2069b 64117-204 HUMAN OTC DRUG COLDS COUGHS AMMONIUM CHLORIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AMMONIUM CHLORIDE 30 [hp_C]/mL N 20181231 64117-205_7382c492-d154-46d8-84e7-e678071320da 64117-205 HUMAN OTC DRUG SKIN ERUPTIONS 7 BACILLUS ANTHRACIS IMMUNOSERUM RABBIT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 30 [hp_C]/mL N 20181231 64117-206_c7bc457c-86b8-4dd7-8f0f-05a000d2c30c 64117-206 HUMAN OTC DRUG RHEUMATIC PAINS 1 APOCYNUM CANNABINUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply APOCYNUM CANNABINUM ROOT 30 [hp_C]/mL N 20181231 64117-207_e8c173dc-60af-4c6f-96c5-c6cc14729e41 64117-207 HUMAN OTC DRUG RHEUMATISM LARYNGITIS SILVER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SILVER 30 [hp_C]/mL N 20181231 64117-208_2fb20527-9c31-4578-ad31-6458dce8e719 64117-208 HUMAN OTC DRUG ACNE ARSENIC TRIBROMIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARSENIC TRIBROMIDE 30 [hp_C]/mL N 20181231 64117-209_6db50402-6344-453b-8b04-595fc12e0d33 64117-209 HUMAN OTC DRUG MUSCLE CRAMPS ARTEMISIA VULGARIS ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARTEMISIA VULGARIS ROOT 30 [hp_C]/mL N 20181231 64117-210_4c6053fe-7d44-4a5e-b25e-55251a930e44 64117-210 HUMAN OTC DRUG HEADACHE FLATULENCE ASCLEPIAS TUBEROSA FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ASCLEPIAS TUBEROSA FLOWERING TOP 30 [hp_C]/mL N 20181231 64117-211_5cf13e14-baab-4539-aaab-982a8a0abb2a 64117-211 HUMAN OTC DRUG HEADACHE INSOMNIA BENZENE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BENZENE 30 [hp_C]/mL N 20181231 64117-212_86ab6a75-6e5a-4394-9e58-561c559b8421 64117-212 HUMAN OTC DRUG COUGH SORE THROAT BROMINE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BROMINE 30 [hp_C]/mL N 20181231 64117-213_9d873a12-55fb-422a-b96a-cde43680d342 64117-213 HUMAN OTC DRUG HEADACHE CALCIUM ARSENATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM ARSENATE 30 [hp_C]/mL N 20181231 64117-214_69a0c290-3cfc-451a-8fd9-b86e27bf154a 64117-214 HUMAN OTC DRUG HEAD COLD CALCIUM SILICATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM SILICATE 30 [hp_C]/mL N 20181231 64117-215_40ab1ef3-199c-48cb-be86-d803a8e8ba23 64117-215 HUMAN OTC DRUG HEADACHE RHEUMATISM CARBON DISULFIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CARBON DISULFIDE 30 [hp_C]/mL N 20181231 64117-216_13022416-d710-4b04-b42f-c3bf7b1105ef 64117-216 HUMAN OTC DRUG SCIATICA RHEUMATISM SILYBUM MARIANUM SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SILYBUM MARIANUM SEED 30 [hp_C]/mL N 20181231 64117-217_a80068dc-b334-4e07-8034-24558278d740 64117-217 HUMAN OTC DRUG HEADACHE ANXIETY AGKISTRODON CONTORTRIX VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AGKISTRODON CONTORTRIX VENOM 30 [hp_C]/mL N 20181231 64117-218_41f2d46f-26e3-47a0-8c9f-721111518db2 64117-218 HUMAN OTC DRUG RINGING IN EARS CHENOPODIUM AMBROSIOIDES PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CHENOPODIUM AMBROSIOIDES 30 [hp_C]/mL N 20181231 64117-219_abaa0f85-b083-49ce-97a4-0d2c8fd93579 64117-219 HUMAN OTC DRUG SKIN ERUPTIONS CHIMAPHILA UMBELLATA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CHIMAPHILA UMBELLATA 30 [hp_C]/mL N 20181231 64117-220_fb164ac6-a326-469d-92fc-97362b647512 64117-220 HUMAN OTC DRUG HEADACHE QUININE ARSENITE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply QUININE ARSENITE 30 [hp_C]/mL N 20181231 64117-221_5cacc40e-3d42-4156-a476-6f176ee81f8b 64117-221 HUMAN OTC DRUG SORE THROAT DIARRHEA HELIANTHEMUM CANADENSE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HELIANTHEMUM CANADENSE 30 [hp_C]/mL N 20181231 64117-222_3dee264e-ed45-46d4-ba56-f0266122a355 64117-222 HUMAN OTC DRUG DIARRHEA VOMITING CUPRIC ARSENITE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CUPRIC ARSENITE 30 [hp_C]/mL N 20181231 64117-223_c3464c37-bf9e-43d0-be23-91bba00b8cc0 64117-223 HUMAN OTC DRUG HEADACHE VOMITING CYCLAMEN PURPURASCENS TUBER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CYCLAMEN PURPURASCENS TUBER 30 [hp_C]/mL N 20181231 64117-224_f5e19fc0-0384-45cd-8a87-7eedfb6e88b0 64117-224 HUMAN OTC DRUG HEADACHE FATIGUE TURNERA DIFFUSA LEAFY TWIG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TURNERA DIFFUSA LEAFY TWIG 30 [hp_C]/mL N 20181231 64117-225_4947fa22-d893-449a-b5ec-05a0e16ec712 64117-225 HUMAN OTC DRUG COLIC DIOSCOREA VILLOSA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DIOSCOREA VILLOSA ROOT 30 [hp_C]/mL N 20181231 64117-226_5e0dcb92-b777-4e50-b5b9-73b98139650f 64117-226 HUMAN OTC DRUG IRRITABLE BLADDER FEVER EUTROCHIUM PURPUREUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply EUTROCHIUM PURPUREUM ROOT 30 [hp_C]/mL N 20181231 64117-227_6e4418bb-5cc0-4b69-bd6d-1a4994bef89f 64117-227 HUMAN OTC DRUG DRY COUGH SKIN ERUPTIONS EUPHORBIA RESINIFERA RESIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply EUPHORBIA RESINIFERA RESIN 30 [hp_C]/mL N 20181231 64117-228_c205bbfd-1228-4eab-a153-f640deb69e41 64117-228 HUMAN OTC DRUG ITCHY SKIN RUNNY NOSE FAGOPYRUM ESCULENTUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FAGOPYRUM ESCULENTUM 30 [hp_C]/mL N 20181231 64117-229_a6119666-56f8-4bc9-abe8-4ab6c948be28 64117-229 HUMAN OTC DRUG SKIN ERUPTIONS RUNNY NOSE FERROUS IODIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FERROUS IODIDE 30 [hp_C]/mL N 20181231 64117-230_4fe4487c-0c03-4595-868d-c0a07953907c 64117-230 HUMAN OTC DRUG WARTS FERRIC PICRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FERRIC PICRATE 30 [hp_C]/mL N 20181231 64117-231_ef2d5930-3084-45f0-90b8-e1f9678f527c 64117-231 HUMAN OTC DRUG ARTHRITIS PAIN FORMIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FORMIC ACID 30 [hp_C]/mL N 20181231 64117-232_be99724e-cdca-470a-b4c6-a6fdbfdffda9 64117-232 HUMAN OTC DRUG DIARRHEA COLIC GAMBOGE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GAMBOGE 30 [hp_C]/mL N 20181231 64117-233_8aac5525-efd3-42c6-ad40-b0de97296eb5 64117-233 HUMAN OTC DRUG COLDS RUNNY NOSE GLYCERIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GLYCERIN 30 [hp_C]/mL N 20181231 64117-234_a18840ac-ba52-42e6-a8bd-cc09d6579543 64117-234 HUMAN OTC DRUG STOMACH CRAMPS GRATIOLA OFFICINALIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GRATIOLA OFFICINALIS 30 [hp_C]/mL N 20181231 64117-235_f5197b0a-8105-4f26-9ad9-d3187fe1e664 64117-235 HUMAN OTC DRUG ITCHY SKIN RASH GRINDELIA HIRSUTULA FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GRINDELIA HIRSUTULA FLOWERING TOP 30 [hp_C]/mL N 20181231 64117-236_3cf2aa14-8d5b-45bd-9962-b0480339884f 64117-236 HUMAN OTC DRUG COLDS NAUSEA VOMITING HELIANTHUS ANNUUS FLOWER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HELIANTHUS ANNUUS FLOWER 30 [hp_C]/mL N 20181231 64117-237_b57e87f9-2a58-412e-af40-6391a7efa854 64117-237 HUMAN OTC DRUG RHEUMATIC PAINS CHAMAELIRIUM LUTEUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CHAMAELIRIUM LUTEUM ROOT 30 [hp_C]/mL N 20181231 64117-238_a795b7da-6fa3-4887-963f-56ab0efcf582 64117-238 HUMAN OTC DRUG PAINFUL COUGH COLIC STAR ANISE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply STAR ANISE 30 [hp_C]/mL N 20181231 64117-239_d2fbcfdd-1f3b-4130-b5c9-c37d33db7b01 64117-239 HUMAN OTC DRUG HEADACHE SORE THROAT INDIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply INDIUM 30 [hp_C]/mL N 20181231 64117-240_887e4c5b-3267-4496-acd7-03ca664ac26b 64117-240 HUMAN OTC DRUG WEAKNESS IRIDIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply IRIDIUM 30 [hp_C]/mL N 20181231 64117-241_6d912b4b-51f8-4122-9bf6-b70d2cfecb7b 64117-241 HUMAN OTC DRUG HEADACHE VOMITING IRIS VERSICOLOR ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply IRIS VERSICOLOR ROOT 30 [hp_C]/mL N 20181231 64117-242_65a07785-7fe7-41fc-9fac-75debe7cf7e1 64117-242 HUMAN OTC DRUG COLIC DIARRHEA IPOMOEA PURGA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply IPOMOEA PURGA ROOT 30 [hp_C]/mL N 20181231 64117-243_75724a59-d976-4970-8a9a-dbbc83bbed2a 64117-243 HUMAN OTC DRUG STOMACH CRAMPS JATROPHA CURCAS SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply JATROPHA CURCAS SEED 30 [hp_C]/mL N 20181231 64117-244_aa4d9339-9ea6-48f1-8aa3-a3229322c8cd 64117-244 HUMAN OTC DRUG RUNNY NOSE COUGH JUSTICIA ADHATODA LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply JUSTICIA ADHATODA LEAF 30 [hp_C]/mL N 20181231 64117-245_8ebad32f-dd2a-43f3-999d-1631ed340ab1 64117-245 HUMAN OTC DRUG HEMORRHOIDS PROCTALGIA POTASSIUM CHLORATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CHLORATE 30 [hp_C]/mL N 20181231 64117-246_5d7aab54-e824-475f-9dac-8ab65b3e9728 64117-246 HUMAN OTC DRUG DYSPEPSIA POTASSIUM NITRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM NITRATE 30 [hp_C]/mL N 20181231 64117-247_967c0507-428a-4781-9aab-3927d74fc444 64117-247 HUMAN OTC DRUG RUNNY NOSE POTASSIUM SILICATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM SILICATE 30 [hp_C]/mL N 20181231 64117-248_c507b8ae-3433-4ee1-9c6b-2103d341fe3d 64117-248 HUMAN OTC DRUG INCONTINENCE VOMITING WOOD CREOSOTE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply WOOD CREOSOTE 30 [hp_C]/mL N 20181231 64117-249_e5d73e00-0622-4956-bd28-7a4d27067a6e 64117-249 HUMAN OTC DRUG HEADACHE CONSTIPATION SKIM MILK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SKIM MILK 30 [hp_C]/mL N 20181231 64117-250_75e8a2a2-3df0-43e5-b65a-ad5034455dea 64117-250 HUMAN OTC DRUG HEADACHE STIFF NECK LACHNANTHES CAROLINIANA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LACHNANTHES CAROLINIANA 30 [hp_C]/mL N 20181231 64117-251_8abf8e7d-aa57-4afa-8cc9-fa39bed6969c 64117-251 HUMAN OTC DRUG ITCHING SKIN CALCIUM HEXAFLUOROSILICATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM HEXAFLUOROSILICATE 30 [hp_C]/mL N 20181231 64117-252_89c38038-c143-4c09-b73e-872c8d215efe 64117-252 HUMAN OTC DRUG RHEUMATISM ARCTIUM LAPPA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARCTIUM LAPPA ROOT 30 [hp_C]/mL N 20181231 64117-253_03a2d032-896c-4904-8e78-d731068a40be 64117-253 HUMAN OTC DRUG RHEUMATIC PAINS LATHYRUS SATIVAS SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LATHYRUS SATIVAS SEED 30 [hp_C]/mL N 20181231 64117-254_c80a6cc8-8ec3-43c5-8e06-d863cf91fb59 64117-254 HUMAN OTC DRUG ASTHMA LEMNA MINOR PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LEMNA MINOR 30 [hp_C]/mL N 20181231 64117-255_f0a0a685-9a08-4cd0-8ebf-0a82ded85248 64117-255 HUMAN OTC DRUG BILIOUSNESS HEADACHE VERONICASTRUM VIRGINICUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VERONICASTRUM VIRGINICUM ROOT 30 [hp_C]/mL N 20181231 64117-256_9b2b953a-f342-457b-85ff-88af4bfb8de4 64117-256 HUMAN OTC DRUG RHEUMATSM LITHIUM CARBONATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LITHIUM CARBONATE 30 [hp_C]/mL N 20181231 64117-257_13efc7bd-98a8-4b61-bb3f-ec15cf9104f3 64117-257 HUMAN OTC DRUG COUGH HEADACHE TOMATO PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TOMATO 30 [hp_C]/mL N 20181231 64117-258_270efe79-57da-4fa8-9608-812a8636bd56 64117-258 HUMAN OTC DRUG COUGH HEADACHE LYCOPUS VIRGINICUS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LYCOPUS VIRGINICUS 30 [hp_C]/mL N 20181231 64117-259_7caa0e3b-6bd1-4e20-b022-7fcdadd7b1af 64117-259 HUMAN OTC DRUG ITCHY SKIN ERUPTIONS MAGNESIUM SULFATE HEPTAHYDRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MAGNESIUM SULFATE HEPTAHYDRATE 30 [hp_C]/mL N 20181231 64117-260_e20e9dd8-0148-4aa7-9227-e6414a26f0ec 64117-260 HUMAN OTC DRUG SKIN ERUPTIONS MANGANESE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MANGANESE 30 [hp_C]/mL N 20181231 64117-261_4cb04806-e22e-4d88-a8a5-3bd8bab0b653 64117-261 HUMAN OTC DRUG DYSPEPSIA MENTHOL PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MENTHOL 30 [hp_C]/mL N 20181231 64117-262_62d09d0a-92ee-4533-8422-615c0f82e688 64117-262 HUMAN OTC DRUG SORE THROAT WITH PALLOR CALOMEL PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALOMEL 30 [hp_C]/mL N 20181231 64117-263_c1996908-9dbf-433d-936e-747518762d11 64117-263 HUMAN OTC DRUG BURNING DIARRHEA MERCURIC SULFATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MERCURIC SULFATE 30 [hp_C]/mL N 20181231 64117-264_1dc2a993-c0c4-4221-b8d4-482002e63cbd 64117-264 HUMAN OTC DRUG COUGH HICCOUGH MOSCHUS MOSCHIFERUS MUSK SAC RESIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MOSCHUS MOSCHIFERUS MUSK SAC RESIN 30 [hp_C]/mL N 20181231 64117-265_ad21c39e-3666-493a-a254-eb095caca888 64117-265 HUMAN OTC DRUG HEMMORHOIDS HYDROCHLORIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HYDROCHLORIC ACID 30 [hp_C]/mL N 20181231 64117-266_4e0a05c6-2268-401a-a44a-fb8ee82c3774 64117-266 HUMAN OTC DRUG HEADACHE SORE THROAT MORELLA CERIFERA ROOT BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MORELLA CERIFERA ROOT BARK 30 [hp_C]/mL N 20181231 64117-267_6f5fbeb8-aa94-494e-9fa4-dd35f9ab4c83 64117-267 HUMAN OTC DRUG HEADACHE DRY COUGH NAJA NAJA VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply NAJA NAJA VENOM 30 [hp_C]/mL N 20181231 64117-268_44329250-8e63-426f-8662-48ff4d44c0ec 64117-268 HUMAN OTC DRUG RUNNY NOSE SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE 30 [hp_C]/mL N 20181231 64117-269_4d7cc8d8-e4d2-4e4a-9362-5254efd041a1 64117-269 HUMAN OTC DRUG INFLAMMATIONS SODIUM NITRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM NITRATE 30 [hp_C]/mL N 20181231 64117-270_7d654476-f534-4ca7-b439-267d01dca76d 64117-270 HUMAN OTC DRUG DYSPEPSIA SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 30 [hp_C]/mL N 20181231 64117-271_116a564c-880d-4130-94b3-79a1145c8bd8 64117-271 HUMAN OTC DRUG HEADACHE NICKEL PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply NICKEL 30 [hp_C]/mL N 20181231 64117-272_552a73cb-c7ec-4b64-b8ea-9fd6a15e5125 64117-272 HUMAN OTC DRUG BLADDER IRRITATION OCIMUM AMERICANUM LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply OCIMUM AMERICANUM LEAF 30 [hp_C]/mL N 20181231 64117-273_f22c6ebe-8234-4be2-85e3-6efa0673b190 64117-273 HUMAN OTC DRUG ITCHY SKIN ERRUPTIONS NERIUM OLEANDER LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply NERIUM OLEANDER LEAF 30 [hp_C]/mL N 20181231 64117-274_d60d3c0a-783c-46ab-8b66-b03e7086ac6a 64117-274 HUMAN OTC DRUG DRY SORE THROAT ONOSMODIUM VIRGINIANUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ONOSMODIUM VIRGINIANUM ROOT 30 [hp_C]/mL N 20181231 64117-275_51f5c91e-8f99-4672-9e86-a8a9b99afe5d 64117-275 HUMAN OTC DRUG HEADACHE PAEONIA OFFICINALIS ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PAEONIA OFFICINALIS ROOT 30 [hp_C]/mL N 20181231 64117-276_216920b5-caab-4897-93b4-a15ccd782fd4 64117-276 HUMAN OTC DRUG HEMORRHOIDS PETROSELINUM CRISPUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PETROSELINUM CRISPUM 30 [hp_C]/mL N 20181231 64117-277_7423412b-3393-48b6-933c-b86df10a5fce 64117-277 HUMAN OTC DRUG MUSCLE SORENESS HEADACHE PHYSOSTIGMA VENENOSUM SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PHYSOSTIGMA VENENOSUM SEED 30 [hp_C]/mL N 20181231 64117-278_7c637c30-d37a-4c77-9769-07bb2055f3cd 64117-278 HUMAN OTC DRUG EARACHE TOOTHACHE PLANTAGO MAJOR PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PLANTAGO MAJOR 30 [hp_C]/mL N 20181231 64117-279_b202a5ff-1c1b-491c-ab3f-f9a3905c1489 64117-279 HUMAN OTC DRUG HEADACHE FRANGULA CALIFORNICA BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FRANGULA CALIFORNICA BARK 30 [hp_C]/mL N 20181231 64117-280_cab3a269-30cf-4941-91f5-51cc329d817c 64117-280 HUMAN OTC DRUG HEADACHE RHODIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply RHODIUM 30 [hp_C]/mL N 20181231 64117-281_e6da9370-092d-41e3-9a06-25b9c0bdc73c 64117-281 HUMAN OTC DRUG SKIN ERUPTIONS TOXICODENDRON VERNIX LEAFY TWIG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TOXICODENDRON VERNIX LEAFY TWIG 30 [hp_C]/mL N 20181231 64117-282_f8825276-16f3-4ab9-9ea1-66cd8ab64b57 64117-282 HUMAN OTC DRUG DYSPEPSIA HEADACHE SUCROSE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SUCROSE 30 [hp_C]/mL N 20181231 64117-283_34c4a894-cdeb-4bea-9f72-798ad690b92b 64117-283 HUMAN OTC DRUG CONGESTIVE HEADACHE SOLANUM NIGRUM TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SOLANUM NIGRUM TOP 30 [hp_C]/mL N 20181231 64117-284_01ebf6fc-4753-4102-a8e7-4dc884544d94 64117-284 HUMAN OTC DRUG ITCHY SKIN RASH SOLIDAGO VIRGAUREA FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SOLIDAGO VIRGAUREA FLOWERING TOP 30 [hp_C]/mL N 20181231 64117-285_0cb8ab53-fdcd-4abe-b4dc-20d136c461ad 64117-285 HUMAN OTC DRUG ITCHY SKIN RASH SYZYGIUM CUMINI SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SYZYGIUM CUMINI SEED 30 [hp_C]/mL N 20181231 64117-286_33f20512-8b93-4ea0-a459-4b21e2910b5a 64117-286 HUMAN OTC DRUG DYSMENORRHEA FATIGUE TANACETUM VULGARE TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TANACETUM VULGARE TOP 30 [hp_C]/mL N 20181231 64117-287_9bbd8dd0-c1ac-41e4-97bd-209b6859023b 64117-287 HUMAN OTC DRUG SKIN ERUPTIONS TELLURIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TELLURIUM 30 [hp_C]/mL N 20181231 64117-288_196a735a-571b-495e-b450-71e71ec1ec22 64117-288 HUMAN OTC DRUG RUNNY NOSE TEUCRIUM MARUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TEUCRIUM MARUM 30 [hp_C]/mL N 20181231 64117-289_d037889e-f3e6-428d-b291-55aeeb9316b4 64117-289 HUMAN OTC DRUG MUSCLE SPASMS THALLIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply THALLIUM 30 [hp_C]/mL N 20181231 64117-290_6ab1a037-f60c-4986-a0a9-91447c48ba0a 64117-290 HUMAN OTC DRUG DIARRHEA CAPSELLA BURSA-PASTORIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CAPSELLA BURSA-PASTORIS 30 [hp_C]/mL N 20181231 64117-291_dd89d931-ace4-4abb-a1ac-abca503eb662 64117-291 HUMAN OTC DRUG NAUSEA TITANIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TITANIUM 30 [hp_C]/mL N 20181231 64117-292_8bfe3836-52d1-4b24-a078-01883667faea 64117-292 HUMAN OTC DRUG SUDDEN NAUSEA VERATRUM VIRIDE ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VERATRUM VIRIDE ROOT 30 [hp_C]/mL N 20181231 64117-293_bafb05ce-c405-47f1-91d5-784455d63bfd 64117-293 HUMAN OTC DRUG DRY COUGH VERBASCUM THAPSUS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VERBASCUM THAPSUS 30 [hp_C]/mL N 20181231 64117-294_5c77bb08-e0fa-4b52-88da-d940e4abd8a8 64117-294 HUMAN OTC DRUG SKIN ERUPTIONS VINCA MINOR PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VINCA MINOR 30 [hp_C]/mL N 20181231 64117-295_d6feabff-69cc-40d0-82a4-e6a523aec288 64117-295 HUMAN OTC DRUG DRY COUGH HEADACHE VIOLA ODORATA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VIOLA ODORATA 30 [hp_C]/mL N 20181231 64117-296_9c92f43d-f519-4f59-a6ad-df95cc5aaa7e 64117-296 HUMAN OTC DRUG HEADCHES PAINFUL MENSTRUATION ZANTHOXYLUM AMERICANUM BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ZANTHOXYLUM AMERICANUM BARK 30 [hp_C]/mL N 20181231 64117-297_a933027a-6267-47ff-b579-d54b227212a3 64117-297 HUMAN OTC DRUG RHEUMATISM GUAIACUM SANCTUM RESIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GUAIACUM SANCTUM RESIN 30 [hp_C]/mL N 20181231 64117-298_10a7aee6-e302-49f8-a905-7016ceb86e25 64117-298 HUMAN OTC DRUG HEADACHE HELODERMA HORRIDUM VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HELODERMA HORRIDUM VENOM 30 [hp_C]/mL N 20181231 64117-299_9fce8b66-c876-499c-86de-754308c68f27 64117-299 HUMAN OTC DRUG NAUSEA VESPA CRABRO PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VESPA CRABRO 30 [hp_C]/mL N 20181231 64117-301_bee637e1-a67c-4373-a615-00398e80f660 64117-301 HUMAN OTC DRUG NHS HEADACHE ADONIS VERNALIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ADONIS VERNALIS 30 [hp_C]/mL N 20181231 64117-302_5987ddca-4bc1-4bd2-a1ed-164c2466e492 64117-302 HUMAN OTC DRUG COLIC with GAS ALETRIS FARINOSA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ALETRIS FARINOSA ROOT 30 [hp_C]/mL N 20181231 64117-303_9b6bf940-29c8-4f6a-8f6d-3ff858e024b2 64117-303 HUMAN OTC DRUG HEADACHE AMYL NITRITE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AMYL NITRITE 30 [hp_C]/1 N 20181231 64117-304_f644d963-bc35-457d-baa0-7bd34795058e 64117-304 HUMAN OTC DRUG DRY COUGH ARALIA RACEMOSA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARALIA RACEMOSA ROOT 30 [hp_C]/1 N 20181231 64117-305_d7939359-30c2-4d81-86f7-1c7db18e6c59 64117-305 HUMAN OTC DRUG COLIC DIARRHEA ARANEUS DIADEMATUS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARANEUS DIADEMATUS 30 [hp_C]/1 N 20181231 64117-400_ee82665e-e588-4edc-b8c1-1144d9268b20 64117-400 HUMAN PRESCRIPTION DRUG ANNALONIUM LEWINII LOPHOPHORA WILLIAMSII FLOWER PELLET ORAL 20150101 UNAPPROVED HOMEOPATHIC Natural Health Supply LOPHOPHORA WILLIAMSII FLOWER 30 [hp_C]/1 N 20181231 64117-401_80d6f98d-6de5-4414-a699-7d575958b333 64117-401 HUMAN PRESCRIPTION DRUG BACILLINUM PULMO BOVINE TUBERCULIN PELLET ORAL 20150101 UNAPPROVED HOMEOPATHIC Natural Health Supply BOVINE TUBERCULIN 30 [hp_C]/1 N 20181231 64117-402_d4315fbf-748b-4ba0-b903-ba7cec5cdf88 64117-402 HUMAN PRESCRIPTION DRUG CRATAEGUS OXYACANTHA CRATAEGUS LAEVIGATA FRUIT PELLET ORAL 20150101 UNAPPROVED HOMEOPATHIC Natural Health Supply CRATAEGUS LAEVIGATA FRUIT 30 [hp_C]/1 N 20181231 64117-403_f4964cff-0b12-463b-a577-64a11f0ce1fd 64117-403 HUMAN PRESCRIPTION DRUG DIPHTHERINUM DIPHTHERINUM PELLET ORAL 20150101 UNAPPROVED HOMEOPATHIC Natural Health Supply DIPHTHERIAL RESPIRATORY PSEUDOMEMBRANE HUMAN 30 [hp_C]/1 N 20181231 64117-404_16097227-eb16-4b2d-88c8-b40ec6914846 64117-404 HUMAN PRESCRIPTION DRUG HIPPOZAENINUM BURKHOLDERIA MALLEI PELLET ORAL 20150101 UNAPPROVED HOMEOPATHIC Natural Health Supply BURKHOLDERIA MALLEI 30 [hp_C]/1 N 20181231 64117-405_56e29b29-2f87-48b4-90e5-ed91a4aac412 64117-405 HUMAN PRESCRIPTION DRUG LYSSIN RABIES VIRUS PELLET ORAL 20150101 UNAPPROVED HOMEOPATHIC Natural Health Supply RABIES VIRUS 30 [hp_C]/1 N 20181231 64117-406_aa05f5cc-eb9f-46a8-9423-93792c7e9dc7 64117-406 HUMAN PRESCRIPTION DRUG MEDORRHINUM GONORRHEAL URETHRAL SECRETION HUMAN PELLET ORAL 20150101 UNAPPROVED HOMEOPATHIC Natural Health Supply GONORRHEAL URETHRAL SECRETION HUMAN 30 [hp_C]/1 N 20181231 64117-407_11b38dd2-fa9f-419a-9a42-f6f3c07c4ac1 64117-407 HUMAN PRESCRIPTION DRUG PSORINUM SCABIES LESION LYSATE (HUMAN) PELLET ORAL 20150101 UNAPPROVED HOMEOPATHIC Natural Health Supply SCABIES LESION LYSATE (HUMAN) 30 [hp_C]/1 N 20181231 64117-408_4d248e5a-33b6-4758-aa5f-c1478cc4b991 64117-408 HUMAN PRESCRIPTION DRUG SYPHILINUM TREPONEMIC SKIN CANKER HUMAN PELLET ORAL 20150101 UNAPPROVED HOMEOPATHIC Natural Health Supply TREPONEMIC SKIN CANKER HUMAN 30 [hp_C]/1 N 20181231 64117-409_3ce38f90-3c3d-4766-87d0-eebff57d14cc 64117-409 HUMAN PRESCRIPTION DRUG TUBERCULINUM TUBERCULIN PURIFIED PROTEIN DERIVATIVE PELLET ORAL 20150101 UNAPPROVED HOMEOPATHIC Natural Health Supply TUBERCULIN PURIFIED PROTEIN DERIVATIVE 30 [hp_C]/1 Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [Chemical/Ingredient] N 20181231 64117-504_be7e2420-282c-4274-aff2-cd8c1783220c 64117-504 HUMAN OTC DRUG Diarrhea ALOE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ALOE 30 [hp_C]/mL N 20181231 64117-518_b06e79d6-ab6c-4010-8aea-34d3099dfa8c 64117-518 HUMAN OTC DRUG NHS Dyspepsia Dyspepsia PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C]/mL N 20181231 64117-519_98830e82-eaf9-45be-ad57-aeffb4be591f 64117-519 HUMAN OTC DRUG Teething Pain TRIBASIC CALCIUM PHOSPHATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TRIBASIC CALCIUM PHOSPHATE 30 [hp_C]/mL N 20181231 64117-524_4eb8b7fa-f29a-4adc-a602-175458dc5aef 64117-524 HUMAN OTC DRUG NHS Insomnia 1 Insomnia 1 PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CAULOPHYLLUM THALICTROIDES ROOT 30 [hp_C]/mL N 20181231 64117-525_bf041952-0cfb-4102-95f7-066b31bed979 64117-525 HUMAN OTC DRUG NHS Hoarse Cough Hoarse Cough PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CAUSTICUM 30 [hp_C]/mL N 20181231 64117-529_f3ee3259-a503-46c4-a6c6-9cb556767e38 64117-529 HUMAN OTC DRUG NHS Muscle Cramps 1 Muscle Cramps 1 PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BLACK COHOSH 30 [hp_C]/mL N 20181231 64117-531_b3f73ddc-1a74-4cab-b814-80b79193777d 64117-531 HUMAN OTC DRUG NHS Insomnia 2 Insomnia 2 PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARABICA COFFEE BEAN 30 [hp_C]/mL N 20181231 64117-534_f5f95dd0-0f87-4742-8f92-931f2d5a8d1f 64117-534 HUMAN OTC DRUG Heartburn CONIUM MACULATUM FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CONIUM MACULATUM FLOWERING TOP 30 [hp_C]/mL N 20181231 64117-535_78007316-3e78-40ba-8a38-17ca6749509f 64117-535 HUMAN OTC DRUG Fever Vomiting CROTALUS HORRIDUS HORRIDUS VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CROTALUS HORRIDUS HORRIDUS VENOM 30 [hp_C]/mL N 20181231 64117-543_fcf0d748-4281-4895-886c-55b5ab09459c 64117-543 HUMAN OTC DRUG Headache NITROGLYCERIN PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply NITROGLYCERIN 30 [hp_C]/mL N 20181231 64117-545_37f3365e-a60d-411d-8881-71c04c098f45 64117-545 HUMAN OTC DRUG Irritated Cracked Skin GRAPHITE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GRAPHITE 30 [hp_C]/mL N 20181231 64117-546_d366eca0-3d16-479d-844c-4057af432763 64117-546 HUMAN OTC DRUG Hemorrhoids Bruises HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 30 [hp_C]/mL N 20181231 64117-548_4ab141cb-57e1-4a87-96a1-e864c4e7cdac 64117-548 HUMAN OTC DRUG Spasmodic Cough HYOSCYAMUS NIGER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HYOSCYAMUS NIGER 30 [hp_C]/mL N 20181231 64117-553_cff7af63-71a7-4727-abdc-6267d12bdb19 64117-553 HUMAN OTC DRUG Nausea Vomiting IPECAC PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply IPECAC 30 [hp_C]/mL E 20171231 64117-556_dbb479cc-a2be-498b-97e2-029b54f64871 64117-556 HUMAN OTC DRUG Sore Throat CANIS LUPUS FAMILIARIS MILK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CANIS LUPUS FAMILIARIS MILK 30 [hp_C]/mL N 20181231 64117-570_02f1f0e9-f4e2-4195-ba98-cab4c3a8d11d 64117-570 HUMAN OTC DRUG Skin Eruptions DAPHNE MEZEREUM BARK PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DAPHNE MEZEREUM BARK 30 [hp_C]/mL N 20181231 64117-577_4a01d4b3-ac4b-4a6d-8d7e-2629225bdb4b 64117-577 HUMAN OTC DRUG Eczema KEROSENE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply KEROSENE 30 [hp_C]/mL N 20181231 64117-580_2459b8ce-2743-478e-95b1-965ef57f9309 64117-580 HUMAN OTC DRUG Sore Throat Inflammation PHYTOLACCA AMERICANA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PHYTOLACCA AMERICANA ROOT 30 [hp_C]/mL N 20181231 64117-581_e0892fe8-5105-405b-9999-4aa746a8cb84 64117-581 HUMAN OTC DRUG Constipation Cramps LEAD PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LEAD 30 [hp_C]/mL N 20181231 64117-585_34ee55f5-1178-4b1a-acb7-408b8335a3bc 64117-585 HUMAN OTC DRUG Eczema RANCID BEEF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply RANCID BEEF 30 [hp_C]/mL N 20181231 64117-587_4d2ad897-95a9-4fd9-a404-2c205c95e9e1 64117-587 HUMAN OTC DRUG Tickling Cough RUMEX CRISPUS ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply RUMEX CRISPUS ROOT 30 [hp_C]/mL N 20181231 64117-592_b1b4aa11-e2c1-40ba-b7ed-e46ac38d49dc 64117-592 HUMAN OTC DRUG PMS Irritability SEPIA OFFICINALIS JUICE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SEPIA OFFICINALIS JUICE 30 [hp_C]/mL N 20181231 64117-595_90bd6538-2664-4f67-b18f-38ed340bc061 64117-595 HUMAN OTC DRUG Skin Eruptions DELPHINIUM STAPHISAGRIA SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DELPHINIUM STAPHISAGRIA SEED 30 [hp_C]/mL N 20181231 64117-596_0e60c2c5-8bf7-439b-87af-5a987eac9547 64117-596 HUMAN OTC DRUG Headache DATURA STRAMONIUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DATURA STRAMONIUM 30 [hp_C]/mL N 20181231 64117-600_52963c2f-c38a-4592-80ac-693406b024b3 64117-600 HUMAN OTC DRUG Warts THUJA OCCIDENTALIS LEAFY TWIG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_C]/mL N 20181231 64117-643_8faf9bdf-23b2-4a30-97b3-10c36eb2addb 64117-643 HUMAN OTC DRUG NHS HIP PAIN GARLIC PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GARLIC 30 [hp_C]/mL N 20181231 64117-705_dcb63a25-9d22-48cd-8b95-9ad84514af4b 64117-705 HUMAN OTC DRUG Hemmorrhoids Hemorrhoids PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HORSE CHESTNUT 30 [hp_C]/mL N 20181231 64117-709_03d2c9dc-1a07-4b30-b97e-7dc65bba08b0 64117-709 HUMAN OTC DRUG Constipation Constipation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ALUMINUM OXIDE 30 [hp_C]/mL N 20181231 64117-714_7f974142-4bbd-4637-92f1-180502712eab 64117-714 HUMAN OTC DRUG Muscle Cramps Muscle Cramps PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SEMECARPUS ANACARDIUM JUICE 30 [hp_C]/mL N 20181231 64117-718_ac1c892f-288e-4fdc-9bc8-b4d469241ed4 64117-718 HUMAN OTC DRUG NHS Rheumatism Rheumatism PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ANTIMONY TRISULFIDE 30 [hp_C]/mL N 20181231 64117-722_d130dc54-3c1a-4961-9282-5149fcbc5027 64117-722 HUMAN OTC DRUG CONSTIPATION ARSENIC PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARSENIC 30 [hp_C]/1 N 20181231 64117-733_22112f85-35ed-40cc-ab9a-397a70f7212a 64117-733 HUMAN OTC DRUG Sore Throat BARIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BARIUM CATION 30 [hp_C]/mL N 20181231 64117-744_5380b237-5618-4ebb-b5b8-f06bcb5073dc 64117-744 HUMAN OTC DRUG NHS Spasms Weakness Spasms Weakness PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SELENICEREUS GRANDIFLORUS STEM 30 [hp_C]/mL N 20181231 64117-748_b2024c8d-7a18-47b6-b936-0349490818c9 64117-748 HUMAN OTC DRUG Sore Throat CALCIUM FLUORIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM FLUORIDE 30 [hp_C]/mL N 20181231 64117-765_9644530c-9477-4489-8b69-d6150b791598 64117-765 HUMAN OTC DRUG Colic Colic PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARTEMISIA CINA FLOWER 30 [hp_C]/mL N 20181231 64117-791_a734b64e-cb12-4d55-93ba-e97e32ab90d8 64117-791 HUMAN OTC DRUG Biliousness Diarrhea IRON PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply IRON 30 [hp_C]/mL N 20181231 64117-805_2a8e3da9-47f7-432a-a856-49538a6c8e43 64117-805 HUMAN OTC DRUG Headache Drowsiness HELLEBORUS NIGER ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HELLEBORUS NIGER ROOT 30 [hp_C]/mL N 20181231 64117-810_183b9d21-2b94-4564-a9ea-1a358ab8073e 64117-810 HUMAN OTC DRUG Colds Yellow Mucous GOLDENSEAL PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GOLDENSEAL 30 [hp_C]/mL N 20181231 64117-831_da34553d-d917-481e-823c-330deaca270b 64117-831 HUMAN OTC DRUG Eczema Potassium Cation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL N 20181231 64117-839_11ed1398-17c7-4561-a5b3-03fbc7300e5e 64117-839 HUMAN OTC DRUG Stomach Cramps 1 LATRODECTUS MACTANS VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LATRODECTUS MACTANS VENOM 30 [hp_C]/mL N 20181231 64117-842_8e193738-73a1-479a-aca5-3c2d78045001 64117-842 HUMAN OTC DRUG Dysmenorrhea Diarrhea LILIUM LANCIFOLIUM BULB PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LILIUM LANCIFOLIUM BULB 30 [hp_C]/mL N 20181231 64117-866_d16da8c7-1429-4b71-bbb3-ab1b26539d1a 64117-866 HUMAN OTC DRUG Headache SODIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM CATION 30 [hp_C]/mL N 20181231 64117-867_73751c2c-c994-4f03-b340-4161aac8156e 64117-867 HUMAN OTC DRUG Skin Eruptions Sodium Chloride PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM CHLORIDE 30 [hp_C]/mL E 20171231 64117-873_cd1f4a4f-9e60-4b5a-ac61-d9d3ef0ef4f2 64117-873 HUMAN OTC DRUG Warts NITRIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply NITRIC ACID 30 [hp_C]/mL N 20181231 64117-888_0e3edf37-f14d-490d-a1a0-8e9069fc365d 64117-888 HUMAN OTC DRUG Neuralgia Numbness PLATINUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PLATINUM 30 [hp_C]/mL N 20181231 64117-902_9b6a6cb5-a75d-457a-95da-6be54482653e 64117-902 HUMAN OTC DRUG Sore Throat Coughs SANGUINARIA CANADENSIS ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SANGUINARIA CANADENSIS ROOT 30 [hp_C]/mL N 20181231 64117-912_7d65c994-e65d-4e87-bf12-f69fb6ffc949 64117-912 HUMAN OTC DRUG Skin Eruptions SPIGELIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SPIGELIA MARILANDICA ROOT 30 [hp_C]/mL N 20181231 64117-921_c670a185-8d45-4b2c-9b9f-cca65c1628e1 64117-921 HUMAN OTC DRUG Headache Restlessness LYCOSA TARANTULA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LYCOSA TARANTULA 30 [hp_C]/mL N 20181231 64117-926_addfd90a-0150-445a-b38a-0b9bfea21c33 64117-926 HUMAN OTC DRUG Ringing in Ears ALLYLTHIOUREA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ALLYLTHIOUREA 30 [hp_C]/mL N 20181231 64117-951_9c251ffc-d99e-4dc4-82a2-f9dcf19a08ad 64117-951 HUMAN OTC DRUG Cold or Allergy Cold or Allergy PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ONION 30 [hp_C]/mL N 20181231 64117-952_4f9e1a70-40bd-42ab-a1c4-d3c7ad269bad 64117-952 HUMAN OTC DRUG Cough ANTIMONY POTASSIUM TARTRATE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ANTIMONY POTASSIUM TARTRATE 30 [hp_C]/mL E 20171231 64117-953_5a6ab8d2-bf54-4b46-9775-6058136b185d 64117-953 HUMAN OTC DRUG Stings, Bites, Swellings APIS MELLIFERA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply APIS MELLIFERA 30 [hp_C]/mL N 20181231 64117-954_02f7544e-c744-4491-864f-64fa77315560 64117-954 HUMAN OTC DRUG Heartburn SILVER CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SILVER CATION 30 [hp_C]/mL N 20181231 64117-955_75fc57a6-df62-4fcc-8805-d7dc7c6a46b7 64117-955 HUMAN OTC DRUG Bruises-Muscle Soreness Bruises-Muscle Soreness PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARNICA MONTANA 30 [hp_C]/mL N 20181231 64117-956_45d61919-3078-4d52-8d25-c35331968fc0 64117-956 HUMAN OTC DRUG NHS Flu Nausea Flu Nausea PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ARSENIC TRIOXIDE 30 [hp_C]/mL N 20181231 64117-957_5325f041-1121-45f7-8814-3f0ea002229d 64117-957 HUMAN OTC DRUG NHS Insomnia Insomnia PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GOLD 30 [hp_C]/mL N 20181231 64117-958_8e23bdc1-190d-477d-9089-f9b6f9935c3e 64117-958 HUMAN OTC DRUG Cramps Spasms COPPER PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply COPPER 30 [hp_C]/mL N 20181231 64117-959_bb143094-af52-4473-b80c-fac0d1a01ec3 64117-959 HUMAN OTC DRUG Fever Inflammations ATROPA BELLADONNA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ATROPA BELLADONNA 30 [hp_C]/mL N 20181231 64117-960_1d30fbd5-61e1-41af-8093-4cc30e257df6 64117-960 HUMAN OTC DRUG Sprains Bruises BELLIS PERENNIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BELLIS PERENNIS 30 [hp_C]/mL N 20181231 64117-961_f323c343-1058-455d-b18f-e10a835ffcc4 64117-961 HUMAN OTC DRUG NHS Headache Flu Headache Flu PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BRYONIA ALBA ROOT 30 [hp_C]/mL N 20181231 64117-962_1740fdad-6d1e-4d74-a129-97caab28f76d 64117-962 HUMAN OTC DRUG NHS Skin Irritation Cuts Skin Irritation Cuts PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALENDULA OFFICINALIS FLOWERING TOP 30 [hp_C]/mL N 20181231 64117-963_58d4c25b-c7a9-4051-9117-7a1eb6a37b25 64117-963 HUMAN OTC DRUG Bladder Irritation LYTTA VESICATORIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LYTTA VESICATORIA 30 [hp_C]/mL N 20181231 64117-964_a548ce7b-28f7-4c9b-9306-d535f556b740 64117-964 HUMAN OTC DRUG NHS Nausea Heartburn Nausea Heartburn PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ACTIVATED CHARCOAL 30 [hp_C]/mL N 20181231 64117-965_80821941-1e98-4632-9427-9fe380279a9c 64117-965 HUMAN OTC DRUG Teething Irritability MATRICARIA RECUTITA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MATRICARIA RECUTITA 30 [hp_C]/mL N 20181231 64117-966_985255e8-d469-4d1f-81d5-d52edea46f99 64117-966 HUMAN OTC DRUG Motion Sickness ANAMIRTA COCCULUS SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply ANAMIRTA COCCULUS SEED 30 [hp_C]/mL N 20181231 64117-967_f7609485-b6c1-4b6a-b8ad-4d0f9cb38934 64117-967 HUMAN OTC DRUG Abdominal Cramps CITRULLUS COLOCYNTHIS FRUIT PULP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CITRULLUS COLOCYNTHIS FRUIT PULP 30 [hp_C]/mL N 20181231 64117-968_bdf9233d-6bf7-4ae1-aff2-3fd17463533a 64117-968 HUMAN OTC DRUG NHS Flu Fever Sudden Onset BAPTISIA TINCTORIA ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BAPTISIA TINCTORIA ROOT 30 [hp_C]/mL N 20181231 64117-969_f611d801-1f50-449a-af53-5ca96d3ef818 64117-969 HUMAN OTC DRUG Spasmodic Cough DROSERA ROTUNDIFOLIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply DROSERA ROTUNDIFOLIA 30 [hp_C]/mL N 20181231 64117-970_04e8a61f-afa0-457b-bf47-07b840224a59 64117-970 HUMAN OTC DRUG Eye Irritation EUPHRASIA STRICTA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply EUPHRASIA STRICTA 30 [hp_C]/mL N 20181231 64117-971_a828c2ed-7a11-4bf3-86f1-e999240d31a4 64117-971 HUMAN OTC DRUG Fever Inflammations FERRUM PHOSPHORICUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply FERRUM PHOSPHORICUM 30 [hp_C]/mL N 20181231 64117-972_79576a76-80cb-4902-b96d-70dc7a43bbd6 64117-972 HUMAN OTC DRUG Flu Headache GELSEMIUM SEMPERVIRENS ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply GELSEMIUM SEMPERVIRENS ROOT 30 [hp_C]/mL N 20181231 64117-973_525015c7-4900-4414-b850-2a89711947b8 64117-973 HUMAN OTC DRUG Cough Runny Nose CALCIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CALCIUM CATION 30 [hp_C]/mL N 20181231 64117-974_eaa1c609-a51e-4115-9c74-f622576886ab 64117-974 HUMAN OTC DRUG Nerve Pain HYPERICUM PERFORATUM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply HYPERICUM PERFORATUM 30 [hp_C]/mL N 20181231 64117-975_c6949594-40dc-4f80-a6aa-20284d83439e 64117-975 HUMAN OTC DRUG Shock Grief STRYCHNOS IGNATII SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply STRYCHNOS IGNATII SEED 30 [hp_C]/mL N 20181231 64117-977_c8ab7fdc-0c4a-48b2-a9b6-545bb3d85a39 64117-977 HUMAN OTC DRUG Nasel congestion Potassium Cation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply POTASSIUM CATION 30 [hp_C]/mL N 20181231 64117-978_14277f5c-ea57-4ba6-9cc3-caefccb90408 64117-978 HUMAN OTC DRUG Sore Throat LACHESIS MUTA VENOM PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LACHESIS MUTA VENOM 30 [hp_C]/mL N 20181231 64117-979_e4669169-9139-494e-8f08-cdb394434614 64117-979 HUMAN OTC DRUG Puncture Wounds Bites LEDUM PALUSTRE TWIG PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LEDUM PALUSTRE TWIG 30 [hp_C]/mL N 20181231 64117-980_4763c084-3869-4de3-a6c3-51d52f3ff5f0 64117-980 HUMAN OTC DRUG Upset Stomach, Constipation LYCOPODIUM CLAVATUM SPORE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/mL N 20181231 64117-981_ef8f7909-fb5b-4244-9e56-2a4116f5b88d 64117-981 HUMAN OTC DRUG Sore Throat MERCURY PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MERCURY 30 [hp_C]/mL N 20181231 64117-982_de5023a3-65be-4028-b221-f78d37d196d4 64117-982 HUMAN OTC DRUG Chills and Fevers Sodium Cation PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SODIUM CATION 30 [hp_C]/mL N 20181231 64117-983_c0e23458-1a47-4739-ab73-fd7105d8ffaa 64117-983 HUMAN OTC DRUG Nausea Constipation STRYCHNOS NUX-VOMICA SEED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/mL N 20181231 64117-984_9dfcfb18-2dca-42f3-81cb-80cee175c768 64117-984 HUMAN OTC DRUG Cough Sore Throat PHOSPHORUS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PHOSPHORUS 30 [hp_C]/mL N 20181231 64117-985_4ebfdc20-fb7d-4934-bae6-d9c0b9f3f79b 64117-985 HUMAN OTC DRUG Headache PHOSPHORIC ACID PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PHOSPHORIC ACID 30 [hp_C]/mL N 20181231 64117-986_389a119b-dc6d-44e1-a152-7bdd5480b0a5 64117-986 HUMAN OTC DRUG Colds Earache PULSATILLA VULGARIS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply PULSATILLA VULGARIS 30 [hp_C]/mL N 20181231 64117-987_c8d8a305-df5f-4c95-850a-4e3b774e77b0 64117-987 HUMAN OTC DRUG Arthritis Pain TOXICODENDRON PUBESCENS LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TOXICODENDRON PUBESCENS LEAF 30 [hp_C]/mL N 20181231 64117-988_0506683a-6af9-4bf8-a355-929c0e6c4aad 64117-988 HUMAN OTC DRUG Sprains, Tendonitis RUTA GRAVEOLENS FLOWERING TOP PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply RUTA GRAVEOLENS FLOWERING TOP 30 [hp_C]/mL N 20181231 64117-989_3620dbbd-73d6-439e-b09c-b17c08e88a58 64117-989 HUMAN OTC DRUG Skin Eruptions SILICON DIOXIDE PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SILICON DIOXIDE 30 [hp_C]/mL N 20181231 64117-990_198b3da6-0d49-43bb-9e64-a76cc7bbf8a5 64117-990 HUMAN OTC DRUG Dry Cough SPONGIA OFFICINALIS SKELETON, ROASTED PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_C]/mL N 20181231 64117-991_8bd15866-7eaf-4a26-b5b4-3fd5665b8d03 64117-991 HUMAN OTC DRUG Skin Rashes Eczema SULFUR PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply SULFUR 30 [hp_C]/mL N 20181231 64117-992_c7e10744-bdcb-4f1c-9051-5079a8005fed 64117-992 HUMAN OTC DRUG Bone Injuries COMFREY ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply COMFREY ROOT 30 [hp_C]/mL N 20181231 64117-993_641e655a-91cd-4ac2-aa8b-68d9ec7c0854 64117-993 HUMAN OTC DRUG Motion Sickness 1 TOBACCO LEAF PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply TOBACCO LEAF 30 [hp_C]/mL N 20181231 64117-994_5948b106-f9fa-4cdd-a390-8fb0621542ff 64117-994 HUMAN OTC DRUG Burns Itchy Skin URTICA URENS PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply URTICA URENS 30 [hp_C]/mL N 20181231 64117-995_39d63b53-8eb8-42e5-ad74-fcce11c910f0 64117-995 HUMAN OTC DRUG Diarrhea Vomiting VERATRUM ALBUM ROOT PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply VERATRUM ALBUM ROOT 30 [hp_C]/mL N 20181231 64117-996_0cba7165-3282-42c7-81be-f37fffea6e40 64117-996 HUMAN OTC DRUG Stomach Cramps AMANITA MUSCARIA VAR. MUSCARIA PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply AMANITA MUSCARIA VAR. MUSCARIA 30 [hp_C]/mL N 20181231 64117-997_015fd2f3-417c-460a-be1f-952963720638 64117-997 HUMAN OTC DRUG NHS Flatulance Slow Digestion Flatulance Slow Digestion PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply CINCHONA OFFICINALIS BARK 30 [hp_C]/mL N 20181231 64117-998_d1dfb7a9-67e3-4cf2-bf77-a5e9790cdead 64117-998 HUMAN OTC DRUG Menstrual Muscle Cramps MAGNESIUM CATION PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply MAGNESIUM CATION 30 [hp_C]/mL N 20181231 64117-999_b6441e97-0c96-46a4-8eb9-b88bf18927e2 64117-999 HUMAN OTC DRUG NHS Rheumatism Eczema Rheumatism Eczema PELLET ORAL 19980604 UNAPPROVED HOMEOPATHIC Natural Health Supply BERBERIS VULGARIS ROOT BARK 30 [hp_C]/mL N 20181231 64121-056_7cf2c895-73ad-498d-a7ef-40d2fae7ca20 64121-056 HUMAN OTC DRUG KE-53PS Gel Hand Sanitizer KE-53PS Gel Hand Sanitizer SOLUTION TOPICAL 20131105 OTC MONOGRAPH NOT FINAL part333A Kinzua Environmental, Inc. ALCOHOL 62 mL/100mL E 20171231 64121-515_24b35ee1-549e-4a6c-94f0-2c9a5651a404 64121-515 HUMAN OTC DRUG KE-53PS Hand Sanitizer ethanol GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Kinzua Environmental Inc. ETHANOL 600 mL/1000mL E 20171231 64125-116_cd25b50f-e1c5-4ed0-a370-e3b8a7b77f01 64125-116 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Excellium Pharmaceutical Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 64125-117_cd25b50f-e1c5-4ed0-a370-e3b8a7b77f01 64125-117 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Excellium Pharmaceutical Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 64125-118_cd25b50f-e1c5-4ed0-a370-e3b8a7b77f01 64125-118 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Excellium Pharmaceutical Inc. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 64125-127_9e9d2d70-0925-4d05-88d1-13b1de4bfc56 64125-127 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20090601 ANDA ANDA040796 Excellium Pharmaceutical Inc. FOLIC ACID 1 mg/1 E 20171231 64125-130_85594a90-366d-4d66-8d80-218dffef94d8 64125-130 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070601 ANDA ANDA040702 Excellium Pharmaceutical Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 64125-131_85594a90-366d-4d66-8d80-218dffef94d8 64125-131 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070601 ANDA ANDA040702 Excellium Pharmaceutical Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 64125-133_9a23d0f8-191b-4a68-b25a-627e22571373 64125-133 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20121101 ANDA ANDA040903 Excellium Pharmaceutical, Inc IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 64125-134_9a23d0f8-191b-4a68-b25a-627e22571373 64125-134 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20121101 ANDA ANDA040903 Excellium Pharmaceutical, Inc IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 64125-135_9a23d0f8-191b-4a68-b25a-627e22571373 64125-135 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20121101 ANDA ANDA040903 Excellium Pharmaceutical, Inc IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 64125-136_819347a9-acae-47b6-bf37-72054d2a2269 64125-136 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20121201 ANDA ANDA090168 Excellium Pharmaceutical, Inc, BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 64125-137_819347a9-acae-47b6-bf37-72054d2a2269 64125-137 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20121201 ANDA ANDA090168 Excellium Pharmaceutical, Inc, BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 64125-138_819347a9-acae-47b6-bf37-72054d2a2269 64125-138 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20121201 ANDA ANDA090168 Excellium Pharmaceutical, Inc, BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 64125-139_a4aaf034-13f3-45f1-ba76-e6e34ab290c7 64125-139 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20121001 ANDA ANDA090195 Excellium Pharmaceutical, Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 64125-140_a4aaf034-13f3-45f1-ba76-e6e34ab290c7 64125-140 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20121001 ANDA ANDA090195 Excellium Pharmaceutical, Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 64125-904_ab3860a3-70b7-40a0-9f32-573c666b59b2 64125-904 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Excellium Pharmaceutical Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 64125-905_ab3860a3-70b7-40a0-9f32-573c666b59b2 64125-905 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Excellium Pharmaceutical Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 64125-906_ab3860a3-70b7-40a0-9f32-573c666b59b2 64125-906 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Excellium Pharmaceutical Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 64126-1234_14db220f-7a28-4235-bd90-04ee0fc17a97 64126-1234 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980317 UNAPPROVED MEDICAL GAS Freedom Medical OXYGEN 99 L/100L E 20171231 64127-054_86862095-2c59-46fd-8d00-7c3ea4855bf7 64127-054 HUMAN OTC DRUG GM Collin Mineral Sun Veil Tinted Zinc oxide CREAM TOPICAL 20110105 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc ZINC OXIDE .125 mL/mL E 20171231 64127-074_4f8dc002-d7f7-4543-b83e-3a33df5de535 64127-074 HUMAN OTC DRUG GM Collin Mineral Sun Zinc oxide and titanium dioxide LOTION TOPICAL 20110420 OTC MONOGRAPH NOT FINAL part352 Laboratoires Dermo Cosmetik Inc. ZINC OXIDE; TITANIUM DIOXIDE .039; .08 mL/mL; mL/mL E 20171231 64127-075_e830aa93-cc54-4a1c-80c6-3353f1f7b549 64127-075 HUMAN OTC DRUG G.M. Collin Acne Salicylic Acid KIT 20091201 OTC MONOGRAPH FINAL part333 Laboratoires Dermo Cosmetik Inc E 20171231 64127-084_567ff01c-685e-4eca-9617-3c188967d28b 64127-084 HUMAN OTC DRUG G.M. Collin Mineral Sun Veil zinc oxide CREAM TOPICAL 20100517 OTC MONOGRAPH FINAL part352 Laboratoires Dermo Cosmetik Inc. ZINC OXIDE .125 mL/mL E 20171231 64127-085_4c38c2c5-1915-4adc-9281-591e20bbb753 64127-085 HUMAN OTC DRUG G.M. Collin Complex Acne salicylic acid OIL TOPICAL 20110225 OTC MONOGRAPH FINAL part333D Laboratoires Dermo Cosmetik Inc. SALICYLIC ACID .01 mL/mL E 20171231 64127-114_8a0a6ea6-7d0d-4524-9af6-0f1b427ece5d 64127-114 HUMAN OTC DRUG GM Collin MINERAL BB titanium dioxide and zinc oxide CREAM TOPICAL 20140214 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc TITANIUM DIOXIDE; ZINC OXIDE 8.5; 4.2 mg/100mL; mg/100mL E 20171231 64127-134_3d692071-b45c-44b8-bf53-99de505b036d 64127-134 HUMAN OTC DRUG GMC Medical Sun Protection zinc oxide and octinoxate CREAM TOPICAL 20140210 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc ZINC OXIDE; OCTINOXATE 11.6; 8.3 mg/100mL; mg/100mL E 20171231 64127-135_310e034a-f3ac-430d-86ba-b3f40d819ffb 64127-135 HUMAN OTC DRUG GMC Medical Acne-Clear salicylic acid GEL TOPICAL 20140210 OTC MONOGRAPH FINAL part333D Laboratoires dermo Cosmetik Inc SALICYLIC ACID 21.2 mg/100mL E 20171231 64127-144_708a8b0c-0daa-45e5-b0d2-0c61200e1839 64127-144 HUMAN OTC DRUG GMC Medical ANTI-AGING TREATMENT zinc oxide and octinoxate KIT 20140210 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc E 20171231 64127-145_ce1fec03-59a9-4a18-81c4-1edef3a44f64 64127-145 HUMAN OTC DRUG GMC Medical Acne-BPO benzoyl peroxide GEL TOPICAL 20140210 OTC MONOGRAPH FINAL part333D Laboratoires dermo Cosmetik Inc BENZOYL PEROXIDE 51.9 mg/100mL E 20171231 64127-154_0e323027-fb5a-4545-9973-cd57dcf5f9cf 64127-154 HUMAN OTC DRUG GMC Medical ANTIOXIDANT AND ANTI-AGING TREATMENT zinc oxide and octinoxate KIT 20140210 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc E 20171231 64127-155_4e90e385-f3f6-49f6-9a65-6a6d4efd8811 64127-155 HUMAN OTC DRUG GMC Medical Acne Treatment salicylic acid and benzoyl peroxide KIT 20140210 OTC MONOGRAPH FINAL part333D Laboratoires dermo Cosmetik Inc E 20171231 64127-164_5eabfaac-317a-4303-9d58-4ed4796dfab4 64127-164 HUMAN OTC DRUG GMC Medical POST PROCEDURE TREATMENT zinc oxide and octinoxate KIT 20140210 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc E 20171231 64127-165_3409098d-66a0-443f-84b4-397ee170932b 64127-165 HUMAN OTC DRUG G.M. COLLIN OXYGENATING TREATMENT Salicylic Acid KIT 20150801 OTC MONOGRAPH FINAL part333D Laboratoires dermo Cosmetik Inc E 20171231 64127-174_c9a20ee6-78f8-4a61-9b48-95f37ddcf8dd 64127-174 HUMAN OTC DRUG GMC Medical zinc oxide and octinoxate KIT 20140210 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik Inc E 20171231 64127-175_ded5159f-5708-4fc7-9346-ed75a429699d 64127-175 HUMAN OTC DRUG G.M. Collin Puracne Treating Salicylic Acid GEL TOPICAL 20170206 OTC MONOGRAPH FINAL part333D Laboratoires dermo Cosmetik Inc SALICYLIC ACID 2000 mg/g N 20181231 64127-184_0f298906-892f-4d8a-bcf5-d6da5cccb59c 64127-184 HUMAN OTC DRUG GM Collin SPF 60 Mineral Sunscreen TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik TITANIUM DIOXIDE; ZINC OXIDE 49; 47 mg/g; mg/g N 20181231 64127-185_16967af2-4b7c-44ca-a747-ea820b2ec431 64127-185 HUMAN OTC DRUG GMC Medical Acne Treating Salicylic Acid GEL TOPICAL 20170201 OTC MONOGRAPH FINAL part333D Laboratoires dermo Cosmetik Inc SALICYLIC ACID 2000 mg/g N 20181231 64127-194_f9bbe9e2-9386-407c-bee6-4a52d11f03e5 64127-194 HUMAN OTC DRUG GMC MEDICAL SUN PROTECTION BROAD SPECTRUM SPF 60 TITANIUM DIOXIDE and ZINC OXIDE CREAM TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik TITANIUM DIOXIDE; ZINC OXIDE 49; 47 mg/g; mg/g N 20181231 64127-204_3f7dcbff-36a5-49c5-8874-510199797ba2 64127-204 HUMAN OTC DRUG GM Collin 50Plus DRY TOUCH SUN PROTECTION Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Laboratoires dermo Cosmetik AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 150; 50; 100 mg/g; mg/g; mg/g; mg/g N 20181231 64140-101_63630bdd-2f27-4a75-bae4-22389139043a 64140-101 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19910101 NDA NDA205840 Greene Respiratory Services, Inc OXYGEN 99 L/100L N 20181231 64141-001_844617a2-98df-4d36-875c-59b0269541e4 64141-001 HUMAN OTC DRUG BOBBI BROWN SKIN FOUNDATION SPF 15 OCTINOXATE 7.5, TITANIUM DIOXIDE 1.0% LIQUID TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part352 BOBBI BROWN PROFESSIONAL COSMETICS INC OCTINOXATE; TITANIUM DIOXIDE 7.5; 1 mL/100mL; mL/100mL E 20171231 64141-002_f3165fe7-eab9-4b7c-957a-de5d45176b81 64141-002 HUMAN OTC DRUG NATURAL FINISH LONG LASTING FOUNDATION SPF 15 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20071001 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 1 mL/100mL; mL/100mL E 20171231 64141-003_d115cd2a-4994-463b-8fe5-cb0887fee26a 64141-003 HUMAN OTC DRUG BRIGHTENING SPOT TREATMENT CORRECTOR SPF 25 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc OCTINOXATE; TITANIUM DIOXIDE 7; .98 mL/100mL; mL/100mL E 20171231 64141-004_14f94091-c417-4a69-b622-ef9aa412e9e4 64141-004 HUMAN OTC DRUG TREATMENT LIPSHINE SPF 15 OCTINOXATE LIPSTICK TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 BOBBI BROWN PROFESSIONAL COSMETICS INC OCTINOXATE 7 g/100g N 20181231 64141-005_7230b432-469b-4af9-9f1f-86c98297ae76 64141-005 HUMAN OTC DRUG BOBBI BROWN BRIGHTENING PROTECTIVE FACE BASE UV SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE, OXYBENZONE CREAM TOPICAL 20100713 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE 5; 5; 3; 3 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 64141-007_6947ca16-f4d3-4aa9-88a4-b0927505b260 64141-007 HUMAN OTC DRUG ILLUMINATING FINISH COMPACT FOUNDATION SPF 12 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. TITANIUM DIOXIDE; OCTINOXATE 6.3; 3 g/100g; g/100g E 20171231 64141-008_611eae2d-9be0-4216-896e-d95b64f4e3ab 64141-008 HUMAN OTC DRUG EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25 OCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; HOMOSALATE; OXYBENZONE; AVOBENZONE 7.5; 5; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 64141-009_dcdbafc6-92ef-4ca4-b0a3-3c5a1ae49080 64141-009 HUMAN OTC DRUG RICH LIP COLOR SPF 12 OCTINOXATE, OCTISALATE LIPSTICK TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; OCTISALATE 5; 2.5 g/100g; g/100g E 20171231 64141-010_230a68b1-8c53-4478-88f4-ef3e3479fb43 64141-010 HUMAN OTC DRUG TINTED MOISTURIZER OIL FREE SPF 15 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 3.5; 1.8 mL/100mL; mL/100mL E 20171231 64141-011_b935941d-7a9a-4e20-8b22-52a4f98f3bba 64141-011 HUMAN OTC DRUG LONG-WEAR EVEN FINISH FOUNDATION BROAD SPECTRUM SPF 15 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 2.9; 1.6 mL/100mL; mL/100mL E 20171231 64141-012_9c7226a9-725e-4907-b05e-6d5569fa99d8 64141-012 HUMAN OTC DRUG BOBBI BROWN BB BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 4; 2.5; 1.1 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 64141-013_e58a54fa-f3cb-484a-837c-315c3332488d 64141-013 HUMAN OTC DRUG BOBBI BROWN SKIN FOUNDATION BROAD SPECTRUM SPF 15 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE .078; .0104 g/mL; g/mL E 20171231 64141-014_39df78bd-6a66-4496-a13a-6d25596e466f 64141-014 HUMAN OTC DRUG BOBBI BROWN SPF 50 PROTECTIVE FACE BASE BROAD SPECTRUM AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .29124; .04854; .04854; .0262116; .029124 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 64141-015_9f9bf265-cc34-4afe-b3cb-cdacff62f029 64141-015 HUMAN OTC DRUG BOBBI BROWN EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25 OCTINOXATE, HOMOSALATE, OXYBENZONE, and AVOBENZONE CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; HOMOSALATE; OXYBENZONE; AVOBENZONE .0821; .0548; .0548; .0219 g/mL; g/mL; g/mL; g/mL N 20181231 64141-018_476f4a17-6015-40e4-9f6a-0df02f5b0fe9 64141-018 HUMAN OTC DRUG Bobbi Brown CC BROAD SPECTRUM SPF 25 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE .08175; .0436; .02725; .01199; .03597 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 64141-019_8782de6f-56eb-4d8a-8958-3c9a675bd3b2 64141-019 HUMAN OTC DRUG BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, and OCTISALATE LIPSTICK TOPICAL 20020201 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 3.5 g/100g; g/100g; g/100g N 20181231 64141-021_c0f985c7-8585-4e5a-ae24-ff976ccc6d71 64141-021 HUMAN OTC DRUG INTENSIVE SKIN SERUM FOUNDATION BROAD SPECTRUM SPF 40 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .043875; .068625; .04275 g/100mL; g/100mL; g/100mL N 20181231 64141-022_056399f2-f699-4876-bb58-b80a0a1468ea 64141-022 HUMAN OTC DRUG BOBBI BROWN INTENSIVE SKIN SERUM FOUNDATION BROAD SPECTRUM SPF 35 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 83.25; 23.31; 14.43 mg/mL; mg/mL; mg/mL N 20181231 64141-023_d664e270-f942-4903-911b-9d1f50443f39 64141-023 HUMAN OTC DRUG SKIN FOUNDATION CUSHION COMPACT BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE PASTE TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 7; 4.5; 4.2 g/100g; g/100g; g/100g N 20181231 64141-024_5ce35669-93be-419f-bf0d-6542546de726 64141-024 HUMAN OTC DRUG BOBBI BROWN BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, and OCTOCRYLENE SPRAY TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .0188; .047; .0423; .02632 g/mL; g/mL; g/mL; g/mL N 20181231 64141-025_903a07d1-021f-4a29-a6ca-4361bf174f8b 64141-025 HUMAN OTC DRUG SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15 OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20170721 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 31.65; 16.88 mg/mL; mg/mL N 20181231 64141-111_3bf0b661-620d-4115-89cd-eb55fe852e2a 64141-111 HUMAN OTC DRUG SKIN FOUNDATION MINERAL MAKEUP SPF 15 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. TITANIUM DIOXIDE; OCTINOXATE 7.8; 3.6 g/100g; g/100g E 20171231 64141-112_9a0492aa-8a22-4f7c-a501-d08440de8185 64141-112 HUMAN OTC DRUG EXTRA REPAIR MOISTURING BALM SPF 25 OCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20110816 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; HOMOSALATE; OXYBENZONE; AVOBENZONE 7.5; 5; 3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 64141-113_6c5c6a34-6fa2-479f-a741-feaa060a82f7 64141-113 HUMAN OTC DRUG BOBBIE BROWN CORRECTIVE SPOT TREATMENT BROAD SPECTRUM SPF 25 OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20120410 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 98; 15.4 mg/mL; mg/mL E 20171231 64141-704_fbd26a47-6b65-414c-bc89-762f8b57a454 64141-704 HUMAN OTC DRUG MOISTURE RICH FOUNDATION SPF 15 OCTINOXATE LIPSTICK TOPICAL 20001001 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE 2.2 mL/100mL N 20181231 64141-718_e64f5ee1-520b-466b-8252-09ab4d0a059d 64141-718 HUMAN OTC DRUG BRIGHTENING POWDER COMPACT FOUNDATION SPF 20 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE POWDER TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 18.6; 7; 5.8 g/100g; g/100g; g/100g E 20171231 64141-743_36f8b37b-41d6-4ddc-8b45-d472e7d80853 64141-743 HUMAN OTC DRUG TINTED MOISTURIZER SPF 15 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20010101 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 3 mL/100mL; mL/100mL E 20171231 64141-814_21fb384b-d29b-40f3-ab0c-64e00562983e 64141-814 HUMAN OTC DRUG BOBBI BROWN EXTRA TINTED MOISTURIZING BALM SPF 25 OCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20040101 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; HOMOSALATE; OXYBENZONE; AVOBENZONE 7.5; 5; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 64141-866_74e12521-1dc3-4b40-b760-0951d38a9a37 64141-866 HUMAN OTC DRUG BOBBI BROWN PROTECTIVE FACE SPF 15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20100706 OTC MONOGRAPH NOT FINAL part352 Bobbi Brown Professional Cosmetics Inc. OCTINOXATE; TITANIUM DIOXIDE 7.5; 1.2 mL/100mL; mL/100mL E 20171231 64141-916_059d1056-8ed8-45e2-9a4a-9397eba1dd5e 64141-916 HUMAN OTC DRUG BOBBI BROWN EXTRA SPF 25 MOISTURIZING BALM HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20001001 OTC MONOGRAPH NOT FINAL part352 BOBBI BROWN PROFESSIONAL COSMETICS INC HOMOSALATE; OCTINOXATE; OXYBENZONE; AVOBENZONE 10; 7.5; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 64169-001_60b57724-03a1-a364-e053-2a91aa0ac5f2 64169-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19971001 NDA NDA205767 Industrial Source OXYGEN 990 mL/L N 20181231 64169-002_94700b38-902c-4a5d-aca2-9480dafadf66 64169-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20140101 NDA NDA205766 Industrial Source NITROGEN 995 mL/L N 20181231 64169-003_5f00a931-4674-43e5-8e45-effca1b8c7de 64169-003 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20160801 NDA NDA205767 Industrial Source OXYGEN 210 mL/L N 20181231 64175-525_ad79d607-d040-4867-8334-3b8f9d71872f 64175-525 HUMAN OTC DRUG Menopause HF Cimicifuga racemosa, Trifolium pratense, Magnesia carbonica, Agnus castus TABLET ORAL 20100801 UNAPPROVED HOMEOPATHIC Foster Regal Laboratories BLACK COHOSH; RED CLOVER; MAGNESIUM CARBONATE; CHASTE TREE 1; 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 64175-991_1a40b1b6-7852-421a-9557-50174b01a995 64175-991 HUMAN OTC DRUG Relax AM-PM Valerian Root, Passiflora, Magnesium Carbonate TABLET ORAL 20120207 UNAPPROVED HOMEOPATHIC Foster Regal Laboratories VALERIAN; PASSIFLORA INCARNATA FLOWER; MAGNESIUM CARBONATE 6; 3; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 64191-515_bc667117-7df3-4a1c-b5c2-630aac65bf40 64191-515 HUMAN OTC DRUG chempace SANI-GEL INSTANT SKIN SANITIZER ethanol GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Chempace Corporation ETHANOL 600 mL/1000mL E 20171231 64193-223_3bdffc8e-b908-4827-b941-31a1f7063125 64193-223 PLASMA DERIVATIVE FEIBA NF Anti-Inhibitor Coagulant Complex KIT 19860131 BLA BLA101447 Baxter Healthcare Corporation E 20171231 64193-224_3bdffc8e-b908-4827-b941-31a1f7063125 64193-224 PLASMA DERIVATIVE FEIBA NF Anti-Inhibitor Coagulant Complex KIT 19860131 BLA BLA101447 Baxter Healthcare Corporation E 20171231 64193-225_3bdffc8e-b908-4827-b941-31a1f7063125 64193-225 PLASMA DERIVATIVE FEIBA NF Anti-Inhibitor Coagulant Complex KIT 19860131 BLA BLA101447 Baxter Healthcare Corporation E 20171231 64193-423_68ab5663-4a4c-408f-b054-4fec9f6b6ac0 64193-423 HUMAN PRESCRIPTION DRUG FEIBA anti-inhibitor coagulant complex KIT 19860131 BLA BLA101447 Baxalta Incorporated N 20181231 64193-424_68ab5663-4a4c-408f-b054-4fec9f6b6ac0 64193-424 HUMAN PRESCRIPTION DRUG FEIBA anti-inhibitor coagulant complex KIT 19860131 BLA BLA101447 Baxalta Incorporated N 20181231 64193-425_68ab5663-4a4c-408f-b054-4fec9f6b6ac0 64193-425 HUMAN PRESCRIPTION DRUG FEIBA anti-inhibitor coagulant complex KIT 19860131 BLA BLA101447 Baxalta Incorporated N 20181231 64193-426_68ab5663-4a4c-408f-b054-4fec9f6b6ac0 64193-426 HUMAN PRESCRIPTION DRUG FEIBA anti-inhibitor coagulant complex KIT 19860131 BLA BLA101447 Baxalta Incorporated N 20181231 64193-445_9eb6af73-3cba-4ea1-b546-fe4f6fd60461 64193-445 PLASMA DERIVATIVE BEBULIN COAGULATION FACTOR IX HUMAN KIT 19920819 BLA BLA103112 Baxalta Incorporated N 20181231 64201-001_0969cc00-d57f-6079-e054-00144ff8d46c 64201-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930601 UNAPPROVED MEDICAL GAS Nix's Medical Supply, Inc. OXYGEN .99 L/L E 20171231 64203-020_c27976db-4405-4141-9fb9-1db6a2b16cab 64203-020 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19930101 UNAPPROVED MEDICAL GAS Schryver Medical Sales and Marketing, Inc. OXYGEN 99 L/100L N 20181231 64205-005_5b19c0fc-71dc-4898-8ea8-ca31ccb2b9f8 64205-005 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 ReadyMeds SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 64205-006_5b19c0fc-71dc-4898-8ea8-ca31ccb2b9f8 64205-006 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 ReadyMeds SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 64205-032_df1f9d8d-4945-4d63-9ec3-43f47ed66bf5 64205-032 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 ReadyMeds WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 64205-048_c89ccdc3-9d35-4d46-93f0-4de254b99040 64205-048 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 ReadyMeds ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 64205-077_f127fece-11a0-457d-8653-763d471ff347 64205-077 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 ReadyMeds MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 64205-078_0217e704-e3f3-4c71-aa01-106adb9ff9c8 64205-078 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 ReadyMeds ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 64205-087_f127fece-11a0-457d-8653-763d471ff347 64205-087 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 ReadyMeds MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 64205-101_d1008381-21e1-4097-bb77-df25a38145e9 64205-101 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 ReadyMeds CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 64205-102_d1008381-21e1-4097-bb77-df25a38145e9 64205-102 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 ReadyMeds CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 64205-104_4689d485-ecc3-4c14-ba94-2eb84459ca0a 64205-104 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120112 ANDA ANDA062058 ReadyMeds AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 64205-106_8669fa89-72e1-4ac8-97b4-50a5ca630321 64205-106 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20120828 ANDA ANDA077923 ReadyMeds MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 64205-108_8669fa89-72e1-4ac8-97b4-50a5ca630321 64205-108 HUMAN PRESCRIPTION DRUG Meloxicam meloxicam TABLET ORAL 20120828 ANDA ANDA077923 ReadyMeds MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 64205-113_4ff3a93c-7273-4ad2-9e79-27c6e2542449 64205-113 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20130516 ANDA ANDA074761 ReadyMeds KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 64205-126_c52473b6-90bb-4cdf-bd43-595b27ec6ab0 64205-126 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 ReadyMeds MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 64205-127_c52473b6-90bb-4cdf-bd43-595b27ec6ab0 64205-127 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 ReadyMeds MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 64205-130_e643d63b-1847-4c87-a17c-dfefac867cf3 64205-130 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20100315 ANDA ANDA090510 ReadyMeds HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 64205-157_be99b97c-5eae-4b31-8da8-b557d8f6abd0 64205-157 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20100723 ANDA ANDA091004 ReadyMeds ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] E 20171231 64205-161_a16f882c-6e69-4551-ae58-9d53f4a16da0 64205-161 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 ReadyMeds MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 64205-181_9750dad0-252f-4a2f-8f03-e3c20f62c88c 64205-181 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 ReadyMeds PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 64205-193_0d970762-e0c3-4093-9a82-75feb39b68df 64205-193 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 ReadyMeds FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64205-207_1b3a8591-6566-4561-93da-6d3d5db1c4b5 64205-207 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 ReadyMeds CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64205-210_ff7e2f5f-f8da-427f-852d-a2f36e027171 64205-210 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 ReadyMeds LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 64205-211_e5944f68-5757-4cd6-ab12-d3388446e5ae 64205-211 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 ReadyMeds LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 64205-212_e5944f68-5757-4cd6-ab12-d3388446e5ae 64205-212 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 ReadyMeds LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 64205-214_ff7e2f5f-f8da-427f-852d-a2f36e027171 64205-214 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 ReadyMeds LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 64205-218_a2bb21a0-5548-426e-9fcb-1d1db9897041 64205-218 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 ReadyMeds METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 64205-219_a4e7a41f-c95d-4726-9e57-0cf382ce4ddb 64205-219 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 ReadyMeds AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 64205-220_b701df7c-4e31-4228-ab81-87d8c13bc54a 64205-220 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 ReadyMeds METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 64205-222_978f94ad-3db9-4985-bd67-60e7e8cfe3ec 64205-222 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 ReadyMeds GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 64205-224_a4e7a41f-c95d-4726-9e57-0cf382ce4ddb 64205-224 HUMAN PRESCRIPTION DRUG AMOXICILLIN amoxicillin TABLET, FILM COATED ORAL 19780710 NDA NDA050754 ReadyMeds AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 64205-225_2a3f0ee4-9ddc-41b0-ade9-465f61ce0ebd 64205-225 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20120104 ANDA ANDA090428 ReadyMeds LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 64205-226_2a3f0ee4-9ddc-41b0-ade9-465f61ce0ebd 64205-226 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20120104 ANDA ANDA090428 ReadyMeds LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 64205-252_db9f5e35-c19b-40b0-a215-6899eb067ce5 64205-252 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20110822 ANDA ANDA070044 ReadyMeds METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 64205-272_04e14584-43e8-454d-a93c-a2f0b083c207 64205-272 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 ReadyMeds SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 64205-333_25d4e3b9-cc3e-4525-a08d-fab3cbdb7b6e 64205-333 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 ReadyMeds METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 64205-357_2701e00c-2d9c-4845-852e-76d10bc4e4b4 64205-357 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 ReadyMeds CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 64205-488_c89ccdc3-9d35-4d46-93f0-4de254b99040 64205-488 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19960314 ANDA ANDA040114 ReadyMeds ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 64205-506_0217e704-e3f3-4c71-aa01-106adb9ff9c8 64205-506 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073025 ReadyMeds ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 64205-520_a54651f7-ec26-4eff-8a65-c1b89cc42f28 64205-520 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER ReadyMeds PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 E 20171231 64205-521_8e16fbac-73fd-4c5c-8a65-3f991d10fafd 64205-521 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 ReadyMeds PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 64205-536_11fbcc9d-c5fe-4062-a68e-9833776fc4c4 64205-536 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 ReadyMeds BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 64205-537_9e1db57a-4e0c-4f46-bd0e-698124854b59 64205-537 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 ReadyMeds LEVOFLOXACIN 500 mg/1 E 20171231 64205-541_d7a25b18-8774-42b7-afff-cf78a0f05274 64205-541 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 ReadyMeds CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 64205-585_9c5798fc-0e62-4967-888c-4db58c9ab86c 64205-585 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 ReadyMeds ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64205-620_e917d45b-e5fd-4ef1-943c-eea347952386 64205-620 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20080725 ANDA ANDA075347 ReadyMeds OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 64205-627_f249793c-3a32-4163-8e17-b3a7f098f37c 64205-627 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 ReadyMeds TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 64205-640_e917d45b-e5fd-4ef1-943c-eea347952386 64205-640 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20080725 ANDA ANDA075347 ReadyMeds OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 64205-655_07f02165-c20c-47bb-aba1-481feb397058 64205-655 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA091576 ReadyMeds MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 64205-739_83abfca3-49a0-4f31-a4e4-ca3882f0021c 64205-739 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 ReadyMeds FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 64205-740_83abfca3-49a0-4f31-a4e4-ca3882f0021c 64205-740 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20040326 ANDA ANDA076796 ReadyMeds FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 64205-745_8e16fbac-73fd-4c5c-8a65-3f991d10fafd 64205-745 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 ReadyMeds PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 64205-820_ab70a357-eb3a-4018-b7c7-a0a6627f4356 64205-820 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19801105 ANDA ANDA087059 ReadyMeds HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 64205-821_ab70a357-eb3a-4018-b7c7-a0a6627f4356 64205-821 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19801105 ANDA ANDA087068 ReadyMeds HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 64205-927_74bf41a6-b284-42fd-a08a-4fc8d7213c7d 64205-927 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 ReadyMeds CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 64205-928_74bf41a6-b284-42fd-a08a-4fc8d7213c7d 64205-928 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 ReadyMeds CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 64205-965_52b33a33-da21-4d86-aa55-393db4046b28 64205-965 HUMAN PRESCRIPTION DRUG Sertraline sertraline hydrochloride TABLET, FILM COATED ORAL 20121106 ANDA ANDA077864 ReadyMeds SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64208-7752_5e53d362-250f-4abd-8b22-d033a722e618 64208-7752 HUMAN PRESCRIPTION DRUG Coagadex Coagulation Factor X Human KIT 20151021 BLA BLA125506 Bio Products Laboratory Limited N 20181231 64208-7753_5e53d362-250f-4abd-8b22-d033a722e618 64208-7753 HUMAN PRESCRIPTION DRUG Coagadex Coagulation Factor X Human KIT 20151021 BLA BLA125506 Bio Products Laboratory Limited N 20181231 64208-8234_94e88ee5-451c-4978-9199-b72c0eb2794f 64208-8234 PLASMA DERIVATIVE Gammaplex HUMAN IMMUNOGLOBULIN G SOLUTION INTRAVENOUS 20101101 BLA BLA125329 Bio Products Laboratory Limited HUMAN IMMUNOGLOBULIN G 5 g/100mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 64208-8235_d1ea2c68-0aa0-479b-ad26-78063e89758d 64208-8235 PLASMA DERIVATIVE Gammaplex HUMAN IMMUNOGLOBULIN G SOLUTION INTRAVENOUS 20170407 BLA BLA125329 Bio Products Laboratory Limited HUMAN IMMUNOGLOBULIN G 5 g/50mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 64220-420_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-420 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 64220-421_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-421 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 64220-422_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-422 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 64220-423_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-423 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 64220-424_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-424 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 64220-425_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-425 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 64220-426_db5b7681-1e06-4ff2-a0c1-5304b298f0f0 64220-426 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20110810 ANDA ANDA078110 Zhejiang Huahai Pharmaceutical Co., Ltd. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 64227-515_ba6051f3-f537-4c1b-8f3a-cda943180584 64227-515 HUMAN OTC DRUG Enbac skin antiseptic/sanitizer contains aloe vera HUSKY 515 GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 Correlated Products Inc. ALCOHOL 600 mL/1000mL E 20171231 64232-004_0ed82332-fa32-4f65-bba3-6e1a9b372994 64232-004 HUMAN OTC DRUG CereusSAN BACILLUS CEREUS CAPSULE ORAL 20161201 UNAPPROVED HOMEOPATHIC sanPharma GmbH BACILLUS CEREUS 6 [hp_X]/1 N 20181231 64232-005_fd42cb18-c4ec-4bd1-ad8d-168c071922a2 64232-005 HUMAN OTC DRUG Firmus BACILLUS FIRMUS SUPPOSITORY RECTAL 20000101 UNAPPROVED HOMEOPATHIC sanPharma GmbH BACILLUS FIRMUS 6 [hp_X]/1 E 20171231 64232-008_c8622036-e568-4da5-959a-362fdba32774 64232-008 HUMAN OTC DRUG FirmuSAN BACILLUS FIRMUS CAPSULE ORAL 20171201 UNAPPROVED HOMEOPATHIC sanPharma GmbH BACILLUS FIRMUS 6 [hp_X]/1 N 20181231 64232-021_638d921e-0aae-4cef-a052-01ef548f86df 64232-021 HUMAN OTC DRUG QuentaSAN PENICILLIUM GLABRUM SUPPOSITORY RECTAL 20170107 UNAPPROVED HOMEOPATHIC sanPharma GmbH PENICILLIUM GLABRUM 3 [hp_X]/1 N 20181231 64232-022_a918e8ea-fd21-4893-b133-50ebde26efe5 64232-022 HUMAN OTC DRUG QuentaSAN PENICILLIUM GLABRUM LIQUID ORAL 20170104 UNAPPROVED HOMEOPATHIC sanPharma GmbH PENICILLIUM GLABRUM 4 [hp_X]/10mL N 20181231 64232-024_7a253f19-16da-4d2b-8f6b-c88348ae4286 64232-024 HUMAN OTC DRUG QuentaSAN PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM CAPSULE ORAL 20161201 UNAPPROVED HOMEOPATHIC sanPharma GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [hp_X]/1 N 20181231 64232-028_3af3a848-0aa5-448a-b7de-6e239ee12bd3 64232-028 HUMAN OTC DRUG CandidaSAN CANDIDA PARAPSILOSIS CAPSULE ORAL 20171120 UNAPPROVED HOMEOPATHIC sanPharma GmbH CANDIDA PARAPSILOSIS 4 [hp_X]/1 N 20181231 64232-029_b83e7883-cb17-4a8d-a317-e3830a96f95e 64232-029 HUMAN OTC DRUG AsperSAN ASPERGILLUS NIGER VAR. NIGER SUPPOSITORY RECTAL 20171201 UNAPPROVED HOMEOPATHIC sanPharma GmbH ASPERGILLUS NIGER VAR. NIGER 3 [hp_X]/1 N 20181231 64232-030_3e14d034-a735-411f-a749-00f1f5437b5d 64232-030 HUMAN OTC DRUG AsperSAN ASPERGILLUS NIGER VAR. NIGER LIQUID ORAL 20170104 UNAPPROVED HOMEOPATHIC sanPharma GmbH ASPERGILLUS NIGER VAR. NIGER 4 [hp_X]/10mL N 20181231 64232-032_de39a183-3f8d-4b13-b987-20bc4a264e09 64232-032 HUMAN OTC DRUG asperSAN ASPERGILLUS NIGER VAR. NIGER CAPSULE ORAL 20171120 UNAPPROVED HOMEOPATHIC sanPharma GmbH ASPERGILLUS NIGER VAR. NIGER 4 [hp_X]/1 N 20181231 64232-037_08e1ded7-c9a6-40ac-ad5c-5ae398790320 64232-037 HUMAN OTC DRUG RoquefoSAN PENICILLIUM ROQUEFORTI CAPSULE ORAL 20161201 UNAPPROVED HOMEOPATHIC sanPharma GmbH PENICILLIUM ROQUEFORTI 4 [hp_X]/1 N 20181231 64232-039_983b2f84-6705-4448-8f4e-fd2c5c9a472e 64232-039 HUMAN OTC DRUG NotaSAN PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM SUPPOSITORY RECTAL 20161201 UNAPPROVED HOMEOPATHIC sanPharma GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 3 [hp_X]/1 N 20181231 64232-040_68cbc3e3-2ae3-431d-9961-7e122fac94ad 64232-040 HUMAN OTC DRUG NotaSAN PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM LIQUID ORAL 20170104 UNAPPROVED HOMEOPATHIC sanPharma GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [hp_X]/10mL N 20181231 64232-041_ac0088f1-85f6-4986-885d-97184fc44814 64232-041 HUMAN OTC DRUG NotaSAN PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM CAPSULE ORAL 20161201 UNAPPROVED HOMEOPATHIC sanPharma GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [hp_X]/1 N 20191231 64232-042_ea5d75fa-42f8-44ef-b405-af32381ef2b6 64232-042 HUMAN OTC DRUG NOTATUM PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM LIQUID ORAL 20160101 UNAPPROVED HOMEOPATHIC sanPharma GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [hp_X]/mL N 20191231 64232-045_ca2e4ff9-981c-47e0-9f1b-a1aede46079a 64232-045 HUMAN OTC DRUG CandiRoqSAN CANDIDA PARAPSILOSIS and PENICILLIUM ROQUEFORTI SUPPOSITORY RECTAL 20170107 UNAPPROVED HOMEOPATHIC sanPharma GmbH CANDIDA PARAPSILOSIS; PENICILLIUM ROQUEFORTI 3; 3 [hp_X]/1; [hp_X]/1 N 20181231 64232-046_db0783ae-ff6b-4028-b902-80a47ff99844 64232-046 HUMAN OTC DRUG NotaQuenSAN PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM and PENICILLIUM GLABRUM SPRAY NASAL 20170104 UNAPPROVED HOMEOPATHIC sanPharma GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM GLABRUM 4; 4 [hp_X]/10mL; [hp_X]/10mL N 20181231 64232-102_d9172584-6f21-4310-a33d-3bc00251957e 64232-102 HUMAN OTC DRUG MucorSAN MUCOR RACEMOSUS CREAM TOPICAL 20170107 UNAPPROVED HOMEOPATHIC sanPharma GmbH MUCOR RACEMOSUS 3 [hp_X]/150mL N 20181231 64232-103_29bfd6d7-49c4-4242-b004-6421b1ea63a8 64232-103 HUMAN OTC DRUG NotaSAN PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM CREAM TOPICAL 20170107 UNAPPROVED HOMEOPATHIC sanPharma GmbH PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 3 [hp_X]/150mL N 20181231 64232-105_2b190348-5c1d-4f88-8210-7edbd25f3377 64232-105 HUMAN OTC DRUG FirmuSAN BACILLUS FIRMUS SUPPOSITORY RECTAL 20000101 UNAPPROVED HOMEOPATHIC sanPharma GmbH BACILLUS FIRMUS 6 [hp_X]/1 N 20191231 64233-221_f5deb320-3d90-4e92-9dc4-22c10429f1af 64233-221 HUMAN OTC DRUG Alco San ALCOHOL GEL TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part333E Mid American Research Chemical Corp ALCOHOL .7 mL/mL N 20181231 64233-515_871d0179-5626-4be3-a84e-5384a906f186 64233-515 HUMAN OTC DRUG ALCO-SAN INSTANT SKIN SANITIZER ALCOHOL GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Mid-American Chemical Research Corporation ALCOHOL 600 mL/1000mL E 20171231 64235-515_ae1c4970-11f5-4d9a-b531-7c9d2f7b9f5f 64235-515 HUMAN OTC DRUG IHS 2000 INSTANT HAND SANITIZER ethanol GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Ruth Industries , Inc. ETHANOL 600 mL/1000mL E 20171231 64238-515_bdd20f31-e6ee-4c0c-b981-ad22b03cc9e7 64238-515 HUMAN OTC DRUG 3P Instant Hand Sanitizer ethanol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 3-P Specialty Inc. ETHANOL 600 mL/1000mL E 20171231 64239-101_039c3f5e-7a16-404b-8869-5ef75769d964 64239-101 HUMAN PRESCRIPTION DRUG PerioChip Chlorhexidine Gluconate INSERT, EXTENDED RELEASE PERIODONTAL 19980501 NDA NDA020774 Dexcel Pharma Technologies Ltd. CHLORHEXIDINE GLUCONATE 2.5 mg/1 Decreased Cell Wall Integrity [PE] E 20171231 64239-404_4881001c-c215-2033-e054-00144ff8d46c 64239-404 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20160701 ANDA ANDA203713 Dexcel Pharma Technologies Ltd. DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 64246-0001_f9266aec-3214-4c17-bc29-dc476da48ade 64246-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010426 UNAPPROVED MEDICAL GAS Foothill Oxygen Service, Inc. OXYGEN 99 L/100L E 20171231 64249-0001_88024b84-c53c-4b58-984b-7f4a6412e3e6 64249-0001 HUMAN OTC DRUG Babyteeth Aconitum Napellus, Belladonna, Borax, Calcarea Phosphorica, Chamomilla, Kali Phosphoricum, Magnesia Phosphorica, Nitricum Acidum, Staphysagria LIQUID ORAL 20140818 UNAPPROVED HOMEOPATHIC VitaMed, LLC ACONITUM NAPELLUS; ATROPA BELLADONNA; SODIUM BORATE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; NITRIC ACID; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 8; 3; 6; 8; 30; 9 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 64249-0002_5c370f63-7d6e-4448-bd57-7f89b1803ba2 64249-0002 HUMAN OTC DRUG Hemvento not applicable SPRAY ORAL 20140818 UNAPPROVED HOMEOPATHIC VitaMed, LLC HORSE CHESTNUT; ARNICA MONTANA; CALCIUM FLUORIDE; MILK THISTLE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT 1; 3; 9; 1; 3; 1; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64249-0003_3d16d777-06ce-44c5-aa77-640e5112447d 64249-0003 HUMAN PRESCRIPTION DRUG Esmenopa not applicable SPRAY ORAL 20140818 UNAPPROVED HOMEOPATHIC VitaMed, LLC CHASTE TREE; ANGELICA SINENSIS ROOT; APIS MELLIFERA; AMERICAN GINSENG; ARNICA MONTANA; BLACK COHOSH; GALIUM APARINE; GLYCYRRHIZA GLABRA; SUS SCROFA OVARY; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 3; 3; 6; 3; 6; 3; 3; 3; 30; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 64249-0004_6143efb9-2c73-4bac-bd23-54fa4a3ed421 64249-0004 HUMAN PRESCRIPTION DRUG MOMLOVE not applicable SPRAY ORAL 20140818 UNAPPROVED HOMEOPATHIC VitaMed, LLC BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; PODOPHYLLUM; ANGUILLA ROSTRATA BLOOD SERUM; SYMPHORICARPOS ALBUS FRUIT; GINGER 6; 3; 6; 6; 30; 200; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 64249-0005_5be2cf65-a6fd-4118-a522-26ec849d17fd 64249-0005 HUMAN OTC DRUG ZIZISNO not applicable SPRAY ORAL 20140818 UNAPPROVED HOMEOPATHIC VitaMed, LLC ANTIMONY POTASSIUM TARTRATE; ACTIVATED CHARCOAL; SUS SCROFA LUNG; MERCURIC CHLORIDE; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; LOBARIA PULMONARIA; TEUCRIUM MARUM 200; 12; 6; 200; 3; 200; 3 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 64253-202_647caa1e-0b68-2553-e053-2991aa0a7822 64253-202 HUMAN PRESCRIPTION DRUG sodium chloride SODIUM CHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20120113 NDA NDA202832 Medefil, Inc. SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 64257-515_40e43bae-98eb-4283-9dad-3c1d8d47696f 64257-515 HUMAN OTC DRUG Chemco Anisha K. Instant Skin Sanitizer HUSKY 515 GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 CHEMCO INDUSTRIES, INC. ALCOHOL 600 mL/1000mL E 20171231 64268-001_d996baf4-d301-4192-9ee7-523ec51b056c 64268-001 HUMAN OTC DRUG TOMMY GIRL ANTIPERSPIRANT DEODORANT ALUMINUM ZIRCONIUM TETRACHLORHYDREX GLY STICK TOPICAL 20010701 OTC MONOGRAPH FINAL part350 TOMMY HILFIGER TOILETRIES ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.4 g/100g N 20181231 64268-694_00574dfc-a7c1-4c99-881e-03a7cb24d83a 64268-694 HUMAN OTC DRUG TOMMY HILFIGER ANTIPERSPIRANT DEODORANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20010101 OTC MONOGRAPH FINAL part350 TOMMY HILFIGER TOILETRIES ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.6 g/100g N 20181231 64269-9902_ad6d99fb-9b13-47d5-b0ed-b2312b2b1274 64269-9902 HUMAN OTC DRUG Scarlight MD HYDROQUINONE LIQUID TOPICAL 20021101 OTC MONOGRAPH NOT FINAL part358 Scarguard Labs, LLC HYDROQUINONE 20 mg/mL N 20181231 64269-9903_617c546b-3088-405c-bc14-d1759573976e 64269-9903 HUMAN OTC DRUG Scarguard MD Hydrocortisone Silicone LIQUID TOPICAL 20011101 OTC MONOGRAPH NOT FINAL part348 Scarguard Labs, LLC HYDROCORTISONE; PHENYL TRIMETHICONE 5; 12 mg/mL; mL/100mL N 20181231 64269-9907_68f62ea7-c771-4f97-905b-9545a64ab142 64269-9907 HUMAN OTC DRUG Solarguard MD Homosalate Oxybenzone Octocrylene Octisalate Avobenzone SPRAY TOPICAL 20090401 OTC MONOGRAPH FINAL part352 Scarguard Labs, LLC HOMOSALATE; OXYBENZONE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 15; 6; 5; 5; 3 mL/100mL; g/100mL; mL/100mL; mL/100mL; g/100mL E 20171231 64269-9909_a2810ad7-8a93-4d1e-9f31-2770f411c24e 64269-9909 HUMAN OTC DRUG Scarguard MD Physicians Formula Hydrocortisone Silicone LIQUID TOPICAL 20011001 OTC MONOGRAPH NOT FINAL part348 Scarguard Labs, LLC HYDROCORTISONE; PHENYL TRIMETHICONE 5.5; 12.75 mg/mL; mL/100mL N 20181231 64269-9910_2a0ec669-297e-4a20-87cf-3a6d59f38a31 64269-9910 HUMAN OTC DRUG Bruiseguard MD ARNICA MONTANA KIT 20090301 UNAPPROVED HOMEOPATHIC Scarguard Labs, LLC E 20171231 64272-736_5c4ad00b-4bb0-46e2-a3da-d8613166cb4c 64272-736 HUMAN OTC DRUG AFRICAN SEA-COCONUT Herbal Mixture Elm SYRUP ORAL 20111220 OTC MONOGRAPH NOT FINAL part356 LUEN FOOK MEDICINE SDN. BHD. ELM 65 mg/5mL N 20181231 64281-100_92d83c7b-3fe0-4b40-8265-b43b92f574f0 64281-100 HUMAN PRESCRIPTION DRUG Provocholine methacholine chloride POWDER, FOR SOLUTION RESPIRATORY (INHALATION) 20130327 NDA NDA019193 Methapharm Inc. METHACHOLINE CHLORIDE 100 mg/100mg Cholinergic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20191231 64305-001_2e11175d-b83d-4a07-83c2-a7f99438edb7 64305-001 HUMAN OTC DRUG symmetry Hand Sanitizer with Aloe and Vitamin E ETHYL ALCOHOL LIQUID TOPICAL 20140522 OTC MONOGRAPH NOT FINAL part333E Project, Inc. ALCOHOL 620 mg/mL N 20181231 64305-003_84dc37f6-c469-43fa-9e96-50b8882f69cc 64305-003 HUMAN OTC DRUG symmetry Foaming Hand Sanitizer with Aloe and Vitamin E ETHYL ALCOHOL LIQUID TOPICAL 20140522 OTC MONOGRAPH NOT FINAL part333E Project, Inc. ALCOHOL 620 mg/mL N 20181231 64305-006_c0ff6b33-abaf-4d4a-a14c-e50b9756c81d 64305-006 HUMAN OTC DRUG symmetry Antimicrobial Foaming Hand Wash CHLOROXYLENOL LIQUID TOPICAL 20140523 OTC MONOGRAPH NOT FINAL part333E Project, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 64305-007_fe62f826-4b87-4046-9cf6-9057603329c7 64305-007 HUMAN OTC DRUG symmetry Non-Alcohol Foaming Hand Sanitizer with Allantoin and Aloe BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140523 OTC MONOGRAPH NOT FINAL part333E Project, Inc. BENZALKONIUM CHLORIDE 1.2 mg/mL N 20181231 64305-009_16217c55-d6b3-4fd0-ae73-e5a1031873a3 64305-009 HUMAN OTC DRUG symmetry Foaming Hand Sanitizer Fragrance Free with Aloe and Vitamin E ETHYL ALCOHOL LIQUID TOPICAL 20140523 OTC MONOGRAPH NOT FINAL part333E Project, Inc. ALCOHOL 620 mg/mL N 20181231 64307-001_6e697a2a-488f-499e-afee-1b7c64a00207 64307-001 HUMAN OTC DRUG Decon Hand Instant Hand Sanitizer Alcohol LIQUID TOPICAL 19990601 OTC MONOGRAPH NOT FINAL part333E Veltek Associates, Inc. ALCOHOL 64.5 mL/100mL N 20181231 64330-001_3d12167b-8a38-4ebe-820a-a69e0a51d504 64330-001 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET ORAL 20170622 ANDA ANDA203586 Centaur Pharmaceuticals Private Limited LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 64370-375_12bd832e-3f44-4ab8-9be3-1f194bea4740 64370-375 HUMAN PRESCRIPTION DRUG HEMANGEOL propranolol hydrochloride SOLUTION ORAL 20140414 NDA NDA205410 Pierre Fabre Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 4.28 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 64370-421_829a580c-1d01-4c37-96a6-d7c4ce27bfa5 64370-421 HUMAN PRESCRIPTION DRUG TOLAK FLUOROURACIL CREAM TOPICAL 20170315 NDA NDA022259 Pierre Fabre Pharmaceuticals, Inc. FLUOROURACIL 40 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 64370-532_3f002c72-3343-4707-a2a6-7ae87aa336b0 64370-532 HUMAN PRESCRIPTION DRUG NAVELBINE Vinorelbine tartrate INJECTION INTRAVENOUS 20051115 NDA NDA020388 Pierre Fabre Pharmaceuticals, Inc. VINORELBINE TARTRATE 10 mg/mL Vinca Alkaloid [EPC],Vinca Alkaloids [Chemical/Ingredient] N 20181231 64376-131_2d68b5fd-88cf-47ec-81eb-b3714d1e0fc0 64376-131 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120817 20180928 ANDA ANDA076890 Par Pharmaceutical LEVOFLOXACIN 500 mg/1 N 20181231 64376-136_86dbc7dc-5852-4e64-a54f-cc69b4db2503 64376-136 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140912 20180930 ANDA ANDA077319 Par Pharmaceutical LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 64376-137_86dbc7dc-5852-4e64-a54f-cc69b4db2503 64376-137 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140912 20181031 ANDA ANDA077319 Par Pharmaceutical LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 64376-138_86dbc7dc-5852-4e64-a54f-cc69b4db2503 64376-138 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140912 20180531 ANDA ANDA077319 Par Pharmaceutical LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 64376-603_3c6b5386-f3bf-4989-b63f-f798203b8c1f 64376-603 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide Methscopolamine Bromide TABLET ORAL 20061228 ANDA ANDA040624 Par Pharmaceutical METHSCOPOLAMINE BROMIDE 2.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 64376-604_3c6b5386-f3bf-4989-b63f-f798203b8c1f 64376-604 HUMAN PRESCRIPTION DRUG Methscopolamine Bromide Methscopolamine Bromide TABLET ORAL 20061228 ANDA ANDA040624 Par Pharmaceutical METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 64376-605_db8a715c-560c-4c71-bb1d-af5eaac4ed01 64376-605 HUMAN PRESCRIPTION DRUG Carbinoxamine Maleate Carbinoxamine Maleate TABLET ORAL 20080530 ANDA ANDA040639 Boca Pharmacal, LLC CARBINOXAMINE MALEATE 4 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 64376-612_db8a715c-560c-4c71-bb1d-af5eaac4ed01 64376-612 HUMAN PRESCRIPTION DRUG Carbinoxamine Maleate Carbinoxamine Maleate SOLUTION ORAL 20080226 ANDA ANDA040814 Boca Pharmacal, LLC CARBINOXAMINE MALEATE 4 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 64376-640_8290717b-fcbf-41bd-af3b-33211c600a58 64376-640 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate, Acetaminophen SOLUTION ORAL 20110727 ANDA ANDA040894 Par Pharmaceutical ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 7.5 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 64376-643_731a2f52-a7bd-4714-9420-c0b8af77709f 64376-643 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110114 ANDA ANDA090415 Par Pharmaceutical HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 64376-648_731a2f52-a7bd-4714-9420-c0b8af77709f 64376-648 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110114 ANDA ANDA090415 Par Pharmaceutical HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 64376-649_731a2f52-a7bd-4714-9420-c0b8af77709f 64376-649 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110114 ANDA ANDA090415 Par Pharmaceutical HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 64376-650_da1efa79-a542-4446-9c82-157dd9bd085a 64376-650 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride TABLET ORAL 20100907 20180930 ANDA ANDA040747 Boca Pharmacal, LLC BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 64376-657_1682acf0-cf84-47e1-9cbc-06873032d641 64376-657 HUMAN PRESCRIPTION DRUG BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP ORAL 20140721 ANDA ANDA202940 Par Pharmaceutical BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 10; 30 mg/5mL; mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 64376-697_2454c405-7576-434a-aa7d-474e3d3aa926 64376-697 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20170101 ANDA ANDA201464 Par Pharmaceutical LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 64376-809_2f3d81a4-f262-4614-aca8-362e0c47ad69 64376-809 HUMAN PRESCRIPTION DRUG Ferrous Sulfate Iron TABLET ORAL 20100914 20180630 UNAPPROVED DRUG OTHER Boca Pharmacal, LLC FERROUS SULFATE 65 mg/1 N 20181231 64380-707_4dc47422-28ed-4bb8-84a7-7cd3815b0d04 64380-707 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET ORAL 20150513 ANDA ANDA079128 Strides Shasun Limited LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 64380-709_d1b9441b-1d3c-402d-98e6-8c1f247c2050 64380-709 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET ORAL 20120522 ANDA ANDA078195 Strides Shasun Limited NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 64380-712_87d6f248-e1a6-4b0d-9d67-79e75397e51b 64380-712 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20160516 ANDA ANDA091133 Strides Shasun Limited BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 64380-713_87d6f248-e1a6-4b0d-9d67-79e75397e51b 64380-713 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20160516 ANDA ANDA091133 Strides Shasun Limited BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 64380-714_61e40f1a-ce90-4c21-9064-c0fa9789d8c7 64380-714 HUMAN PRESCRIPTION DRUG TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET ORAL 20180126 ANDA ANDA090742 Strides Shasun Limited TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 64380-715_c69bdda3-ac32-412d-b5c2-a6a0119bb0f4 64380-715 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20090514 ANDA ANDA077928 Strides Shasun Limited MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 64380-716_c69bdda3-ac32-412d-b5c2-a6a0119bb0f4 64380-716 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20090514 ANDA ANDA077928 Strides Shasun Limited MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 64380-717_124ca30e-ea2f-418c-a365-6e12d7363e70 64380-717 HUMAN PRESCRIPTION DRUG Abacavir Abacavir TABLET ORAL 20161028 ANDA ANDA091050 Strides Shasun Limited ABACAVIR SULFATE 300 1/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 64380-720_22bb57aa-6ccc-481d-b93c-7ac2f66a37e7 64380-720 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20140813 ANDA ANDA090687 Strides Shasun Limited TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 64380-721_22bb57aa-6ccc-481d-b93c-7ac2f66a37e7 64380-721 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20140813 ANDA ANDA090687 Strides Shasun Limited TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 64380-722_22bb57aa-6ccc-481d-b93c-7ac2f66a37e7 64380-722 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20140813 ANDA ANDA090687 Strides Shasun Limited TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 64380-723_8f038f36-c63b-4484-b3e6-80a22401cc2f 64380-723 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol Capsules 0.25 mcg CAPSULE ORAL 20141212 ANDA ANDA091356 Strides Shasun Limited CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 64380-724_8f038f36-c63b-4484-b3e6-80a22401cc2f 64380-724 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol Capsules 0.5 mcg CAPSULE ORAL 20141212 ANDA ANDA091356 Strides Shasun Limited CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 64380-725_5acbae58-1ede-47d5-b106-aba06870567a 64380-725 HUMAN PRESCRIPTION DRUG Mycophenolate mofetil Mycophenolate mofetil TABLET, FILM COATED ORAL 20101106 ANDA ANDA090456 Strides Shasun Limited MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 64380-726_5acbae58-1ede-47d5-b106-aba06870567a 64380-726 HUMAN PRESCRIPTION DRUG Mycophenolate mofetil Mycophenolate mofetil CAPSULE ORAL 20101106 ANDA ANDA090055 Strides Shasun Limited MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 64380-732_042f2c2e-02cd-4781-b301-8e4f2f2bd399 64380-732 HUMAN OTC DRUG IBUPROFEN AND DIPHENHYDRAMINE HCL IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED ORAL 20120305 ANDA ANDA200888 Strides Shasun Limited DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25; 200 mg/1; mg/1 N 20181231 64380-734_94553560-82a0-4100-8857-3f678e34a5bc 64380-734 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20130630 ANDA ANDA200770 Strides Shasun Limited HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 64380-735_94553560-82a0-4100-8857-3f678e34a5bc 64380-735 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20130630 ANDA ANDA200770 Strides Shasun Limited HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 64380-736_94553560-82a0-4100-8857-3f678e34a5bc 64380-736 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20130630 ANDA ANDA200770 Strides Shasun Limited HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 64380-737_0bc25c22-a6bb-4d7c-ab28-441fc526c79c 64380-737 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20140516 ANDA ANDA090455 Strides Shasun Limited ERGOCALCIFEROL 1.25 1/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 64380-741_89b16753-ee83-42aa-b3b5-18fba56fe02e 64380-741 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20150630 ANDA ANDA202330 Strides Shasun Limited BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 64380-742_89b16753-ee83-42aa-b3b5-18fba56fe02e 64380-742 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20150630 ANDA ANDA202330 Strides Shasun Limited BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 64380-743_89b16753-ee83-42aa-b3b5-18fba56fe02e 64380-743 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20150630 ANDA ANDA202330 Strides Shasun Limited BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 64380-744_89b16753-ee83-42aa-b3b5-18fba56fe02e 64380-744 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20150630 ANDA ANDA202330 Strides Shasun Limited BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 64380-745_4fce4cf6-8389-4fa7-8afa-3262b065647c 64380-745 HUMAN PRESCRIPTION DRUG memantine hydrochloride memantine hydrochloride TABLET ORAL 20170523 ANDA ANDA202350 Strides Shasun Limited MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 64380-746_bad9d11d-99aa-448d-b303-8319dfb99df7 64380-746 HUMAN PRESCRIPTION DRUG pramipexole dihydrochloride pramipexole dihydrochloride TABLET ORAL 20140603 ANDA ANDA202702 Strides Shasun Limited PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64380-747_bad9d11d-99aa-448d-b303-8319dfb99df7 64380-747 HUMAN PRESCRIPTION DRUG pramipexole dihydrochloride pramipexole dihydrochloride TABLET ORAL 20140603 ANDA ANDA202702 Strides Shasun Limited PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64380-748_bad9d11d-99aa-448d-b303-8319dfb99df7 64380-748 HUMAN PRESCRIPTION DRUG pramipexole dihydrochloride pramipexole dihydrochloride TABLET ORAL 20140603 ANDA ANDA202702 Strides Shasun Limited PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64380-749_bad9d11d-99aa-448d-b303-8319dfb99df7 64380-749 HUMAN PRESCRIPTION DRUG pramipexole dihydrochloride pramipexole dihydrochloride TABLET ORAL 20140603 ANDA ANDA202702 Strides Shasun Limited PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64380-750_bad9d11d-99aa-448d-b303-8319dfb99df7 64380-750 HUMAN PRESCRIPTION DRUG pramipexole dihydrochloride pramipexole dihydrochloride TABLET ORAL 20140603 ANDA ANDA202702 Strides Shasun Limited PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64380-751_bad9d11d-99aa-448d-b303-8319dfb99df7 64380-751 HUMAN PRESCRIPTION DRUG pramipexole dihydrochloride pramipexole dihydrochloride TABLET ORAL 20140603 ANDA ANDA202702 Strides Shasun Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64380-752_326d98b4-5bee-44ee-b376-249728093e36 64380-752 HUMAN PRESCRIPTION DRUG Methoxsalen Methoxsalen CAPSULE, LIQUID FILLED ORAL 20140613 ANDA ANDA202687 Strides Shasun Limited METHOXSALEN 10 mg/1 Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient] N 20181231 64380-758_72b601dc-f0f3-4b61-98fe-e543468314c2 64380-758 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20110728 ANDA ANDA090912 Strides Shasun Limited ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 64380-759_72b601dc-f0f3-4b61-98fe-e543468314c2 64380-759 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20110728 ANDA ANDA090912 Strides Shasun Limited ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 64380-760_72b601dc-f0f3-4b61-98fe-e543468314c2 64380-760 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20110728 ANDA ANDA090912 Strides Shasun Limited ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 64380-763_56c48f88-725f-437b-9d7e-62c42abd9cdf 64380-763 HUMAN PRESCRIPTION DRUG Dutasteride Dutasteride CAPSULE, LIQUID FILLED ORAL 20151120 ANDA ANDA204262 Strides Shasun Limited DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 64380-768_f45454d6-8f59-43f7-bd1f-f05178bbfafc 64380-768 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored POWDER, FOR SOLUTION ORAL 20150414 ANDA ANDA204559 Strides Shasun Limited POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE 420; 11.2; 5.72; 1.48 g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 64380-769_f45454d6-8f59-43f7-bd1f-f05178bbfafc 64380-769 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Lemon Flavor Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Lemon Flavor POWDER, FOR SOLUTION ORAL 20150414 ANDA ANDA204559 Strides Shasun Limited POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE 420; 11.2; 5.72; 1.48 g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 64380-770_f45454d6-8f59-43f7-bd1f-f05178bbfafc 64380-770 HUMAN PRESCRIPTION DRUG Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Orange Flavor Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Orange Flavor POWDER, FOR SOLUTION ORAL 20150414 ANDA ANDA204559 Strides Shasun Limited POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE 420; 11.2; 5.72; 1.48 g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 64380-773_cdd54008-c33a-4adb-96a8-65e062a0b0a8 64380-773 HUMAN PRESCRIPTION DRUG imiquimod imiquimod CREAM TOPICAL 20140624 ANDA ANDA202002 Strides Shasun Limited IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] N 20181231 64380-774_4fce4cf6-8389-4fa7-8afa-3262b065647c 64380-774 HUMAN PRESCRIPTION DRUG memantine hydrochloride memantine hydrochloride TABLET ORAL 20170523 ANDA ANDA202350 Strides Shasun Limited MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 64380-779_8a4f5470-4668-4144-9035-1d5242d2cd03 64380-779 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20160525 ANDA ANDA208162 Strides Shasun Limited METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 64380-780_8a4f5470-4668-4144-9035-1d5242d2cd03 64380-780 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20160525 ANDA ANDA208162 Strides Shasun Limited METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 64380-787_89b16753-ee83-42aa-b3b5-18fba56fe02e 64380-787 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20170217 ANDA ANDA202330 Strides Shasun Limited BUSPIRONE HYDROCHLORIDE 7.5 mg/1 N 20181231 64380-788_0aad5cc2-4438-4a6c-a98f-57f370621366 64380-788 HUMAN OTC DRUG NUPRIN IMMEDIATE RELEASE IBUPROFEN TABLET, COATED ORAL 20151216 ANDA ANDA079129 Strides Arcolab Limited IBUPROFEN 200 mg/1 N 20181231 64380-792_53def2cc-0266-485a-a982-8434cc06b50a 64380-792 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20170630 ANDA ANDA209177 Strides Shasun Limited PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 64380-793_53def2cc-0266-485a-a982-8434cc06b50a 64380-793 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20170630 ANDA ANDA209177 Strides Shasun Limited PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 64380-794_53def2cc-0266-485a-a982-8434cc06b50a 64380-794 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20170630 ANDA ANDA209177 Strides Shasun Limited PROMETHAZINE HYDROCHLORIDE 50 1/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 64380-803_6b2c6d5b-6863-4e91-bc74-bd4ec9f9a55d 64380-803 HUMAN PRESCRIPTION DRUG Ranitidine Immediate release Ranitidine TABLET ORAL 20160829 ANDA ANDA205512 Strides Shasun Limited RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 64380-804_6b2c6d5b-6863-4e91-bc74-bd4ec9f9a55d 64380-804 HUMAN PRESCRIPTION DRUG Ranitidine Immediate release Ranitidine TABLET ORAL 20160829 ANDA ANDA205512 Strides Shasun Limited RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 64380-833_995e0756-044e-4512-b7af-cdda9416cd30 64380-833 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 20171121 ANDA ANDA209734 Strides Shasun Limited ACETAZOLAMIDE 125 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 64380-834_995e0756-044e-4512-b7af-cdda9416cd30 64380-834 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 20171121 ANDA ANDA209734 Strides Shasun Limited ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 64380-836_88a3faf9-f2d0-48db-a8b8-b921f556cd26 64380-836 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide OINTMENT TOPICAL 20180131 ANDA ANDA210077 Strides Shasun Limited NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 64380-842_20b5975b-c0bc-483a-a213-cc4734c4074d 64380-842 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20180126 ANDA ANDA210347 Strides Shasun Limited PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 64380-843_20b5975b-c0bc-483a-a213-cc4734c4074d 64380-843 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20180126 ANDA ANDA210347 Strides Shasun Limited PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 64395-0001_efff3240-b679-41ce-a00e-67b187a55bc5 64395-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980724 UNAPPROVED MEDICAL GAS Pacific Island Medical, Inc. OXYGEN 99 L/100L E 20171231 64406-005_a96f7e94-030e-4cda-9381-af5649003063 64406-005 HUMAN PRESCRIPTION DRUG Tecfidera dimethyl fumarate CAPSULE ORAL 20130327 NDA NDA204063 Biogen Inc. DIMETHYL FUMARATE 120 mg/1 N 20181231 64406-006_a96f7e94-030e-4cda-9381-af5649003063 64406-006 HUMAN PRESCRIPTION DRUG Tecfidera dimethyl fumarate CAPSULE ORAL 20130327 NDA NDA204063 Biogen Inc. DIMETHYL FUMARATE 240 mg/1 N 20181231 64406-007_a96f7e94-030e-4cda-9381-af5649003063 64406-007 HUMAN PRESCRIPTION DRUG Tecfidera dimethyl fumarate KIT 20130327 NDA NDA204063 Biogen Inc. N 20181231 64406-008_b6ed509c-81c4-4ba6-9560-60bdae9f37e7 64406-008 HUMAN PRESCRIPTION DRUG TYSABRI natalizumab INJECTION INTRAVENOUS 20041123 BLA BLA125104 Biogen Inc. NATALIZUMAB 300 mg/15mL Integrin Receptor Antagonist [EPC],Integrin Receptor Antagonists [MoA] N 20181231 64406-011_e3c25fe9-a1f5-4c44-a764-52001c7d4465 64406-011 HUMAN PRESCRIPTION DRUG Plegridy Pen peginterferon beta-1a INJECTION, SOLUTION SUBCUTANEOUS 20140815 BLA BLA125499 Biogen Inc. PEGINTERFERON BETA-1A 125 ug/.5mL N 20181231 64406-012_e3c25fe9-a1f5-4c44-a764-52001c7d4465 64406-012 HUMAN PRESCRIPTION DRUG Plegridy Pen peginterferon beta-1a KIT 20140815 BLA BLA125499 Biogen Inc. N 20181231 64406-015_e3c25fe9-a1f5-4c44-a764-52001c7d4465 64406-015 HUMAN PRESCRIPTION DRUG Plegridy peginterferon beta-1a INJECTION, SOLUTION SUBCUTANEOUS 20140815 BLA BLA125499 Biogen Inc. PEGINTERFERON BETA-1A 125 ug/.5mL N 20181231 64406-016_e3c25fe9-a1f5-4c44-a764-52001c7d4465 64406-016 HUMAN PRESCRIPTION DRUG Plegridy peginterferon beta-1a KIT 20140815 BLA BLA125499 Biogen Inc. N 20181231 64406-058_8aa740cd-52b2-4ee0-a324-28ca9b1d3830 64406-058 HUMAN PRESCRIPTION DRUG Spinraza Nusinersen INJECTION, SOLUTION INTRATHECAL 20161223 NDA NDA209531 Biogen NUSINERSEN 2.4 mg/mL Survival Motor Neuron-2-directed RNA Interaction [EPC],Antisense Oligonucleotide [EPC],Oligonucleotides, Antisense [Chemical/Ingredient],Increased Protein Synthesis [PE] N 20181231 64406-801_d25b3c7e-cc02-4988-ace5-b238e42bd458 64406-801 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Inc. N 20181231 64406-802_d25b3c7e-cc02-4988-ace5-b238e42bd458 64406-802 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Inc. N 20181231 64406-803_d25b3c7e-cc02-4988-ace5-b238e42bd458 64406-803 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Inc. N 20181231 64406-804_d25b3c7e-cc02-4988-ace5-b238e42bd458 64406-804 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Inc. N 20181231 64406-805_d25b3c7e-cc02-4988-ace5-b238e42bd458 64406-805 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Inc. N 20181231 64406-806_d25b3c7e-cc02-4988-ace5-b238e42bd458 64406-806 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Inc. N 20181231 64406-807_d25b3c7e-cc02-4988-ace5-b238e42bd458 64406-807 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Inc. N 20181231 64406-808_d25b3c7e-cc02-4988-ace5-b238e42bd458 64406-808 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Inc. N 20181231 64406-809_d25b3c7e-cc02-4988-ace5-b238e42bd458 64406-809 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Inc. N 20181231 64406-810_d25b3c7e-cc02-4988-ace5-b238e42bd458 64406-810 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Biogen Inc. N 20181231 64406-911_ec45b956-68f2-468e-9bdb-5c45d08aebf9 64406-911 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140505 BLA BLA125444 Biogen Inc. N 20181231 64406-922_ec45b956-68f2-468e-9bdb-5c45d08aebf9 64406-922 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140505 BLA BLA125444 Biogen Inc. N 20181231 64406-933_ec45b956-68f2-468e-9bdb-5c45d08aebf9 64406-933 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140505 BLA BLA125444 Biogen Inc. N 20181231 64406-944_ec45b956-68f2-468e-9bdb-5c45d08aebf9 64406-944 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140505 BLA BLA125444 Biogen Inc. N 20181231 64406-966_ec45b956-68f2-468e-9bdb-5c45d08aebf9 64406-966 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20160218 BLA BLA125444 Biogen Inc. N 20181231 64406-977_ec45b956-68f2-468e-9bdb-5c45d08aebf9 64406-977 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20161028 BLA BLA125444 Biogen Inc. N 20181231 64412-2850_bfbf86e3-deda-40bb-bbf1-5725409a9e1a 64412-2850 HUMAN OTC DRUG Badger Diaper ZINC OXIDE CREAM TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 Twincraft Inc ZINC OXIDE 10 g/100mL N 20181231 64412-4603_dfc5e8ae-c789-47ef-bcc0-a769c375d470 64412-4603 HUMAN OTC DRUG Badger Unscented SPF 15 Sunscreen ZINC OXIDE CREAM TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Twincraft Inc ZINC OXIDE 10 g/100mL N 20181231 64412-4703_a3cc4e39-2b0a-44d6-b1d5-adc3377d0b92 64412-4703 HUMAN OTC DRUG Badger Lavender SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Twincraft Inc ZINC OXIDE 18.75 g/100mL N 20181231 64412-4730_dd643961-8f53-42e2-a290-d4381fa4ee8f 64412-4730 HUMAN OTC DRUG Badger SPF 34 Anti-Bug Sunscreen ZINC OXIDE CREAM TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Twincraft Inc ZINC OXIDE 20 g/100mL N 20181231 64412-4740_e79cfee9-3c81-42a4-b8b0-e33fe9e78e16 64412-4740 HUMAN OTC DRUG Badger Unscented SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Twincraft Inc ZINC OXIDE 18.75 g/100mL N 20181231 64412-4741_2db3ba54-698f-46cc-b281-98d003040002 64412-4741 HUMAN OTC DRUG Badger Tinted Unscented SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Twincraft Inc ZINC OXIDE 18.75 g/100mL N 20181231 64412-4750_2f1fcc09-59a0-48ab-81e9-ad3d9dde6c52 64412-4750 HUMAN OTC DRUG Badger Baby SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Twincraft Inc ZINC OXIDE 18.75 g/100mL N 20181231 64412-4760_b6ddcda3-a662-44cf-9f63-850b3a68dfde 64412-4760 HUMAN OTC DRUG Badger Sport SPF 35 Sunscreen ZINC OXIDE CREAM TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Twincraft Inc ZINC OXIDE 22.5 g/100mL N 20181231 64412-4780_f317396a-b2f7-4497-9574-0b0ca8ff4a33 64412-4780 HUMAN OTC DRUG Badger Kids SPF 30 Sunscreen ZINC OXIDE CREAM TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Twincraft Inc ZINC OXIDE 18.75 g/100mL N 20181231 64418-1122_60c9ab35-4b5c-383d-e053-2a91aa0a26ad 64418-1122 HUMAN OTC DRUG Senna sennosides TABLET ORAL 20140919 OTC MONOGRAPH NOT FINAL part334 Ideal Protein of America Inc. SENNOSIDES A AND B 8.6 mg/1 N 20181231 64453-0100_96fd18f2-36a9-445e-a652-c7707ad79486 64453-0100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980512 UNAPPROVED MEDICAL GAS PhilCare Home Medical Equipment, Inc. OXYGEN 99 L/100L E 20171231 64454-0001_7fd63ee5-6b49-435d-bdf2-06533f705572 64454-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980413 UNAPPROVED MEDICAL GAS Great Lakes Home Healthcare Services OXYGEN 99 L/100L E 20171231 64464-001_d651e6ec-0b82-42da-94c4-13be4641c4f1 64464-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS O2 Plus, Inc OXYGEN 99 L/100L N 20181231 64471-054_dcf54f76-8e56-47c4-971b-c43656f5f888 64471-054 HUMAN OTC DRUG Wellness Cold and Flu Echinacea (Angustifolia), Allium Cepa, Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Sanguinaria Canadensis, Kali Bichromicum, Phosphorus, Aconitum Napellus, Influenzinum TABLET ORAL 20150608 20190805 UNAPPROVED HOMEOPATHIC Source Naturals, Inc. ECHINACEA ANGUSTIFOLIA; ONION; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; SANGUINARIA CANADENSIS ROOT; POTASSIUM DICHROMATE; PHOSPHORUS; ACONITUM NAPELLUS; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/PERTH/16/2009 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) 3; 4; 4; 4; 4; 4; 6; 6; 12; 12; 12; 12 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 64471-116_45541858-1e5c-4166-bee1-456a37c295d0 64471-116 HUMAN OTC DRUG Wellness Cold and Flu Echinacea (Angustifolia), Allium Cepa, Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Sanguinaria Canadensis, Kali Bichromicum, Phosphorus, Aconitum Napellus, Influenzinum TABLET ORAL 20150911 20201002 UNAPPROVED HOMEOPATHIC Source Naturals, Inc. ECHINACEA ANGUSTIFOLIA; ONION; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; SANGUINARIA CANADENSIS ROOT; POTASSIUM DICHROMATE; PHOSPHORUS; ACONITUM NAPELLUS; INFLUENZA A VIRUS; INFLUENZA B VIRUS 3; 4; 4; 4; 4; 4; 6; 6; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 64471-164_0aebe19d-7d04-40dc-a35d-1e74e4e6a98d 64471-164 HUMAN OTC DRUG Wellness Cold and Flu Echinacea (Angustifolia), Allium Cepa, Bryonia (Alba), Gelsemium Sempervirens, Sanguinaria Canadensis, Eupatorium Perfoliatum, Kali Bichromicum, Phosphorus, Aconitum Napellus, Influenzinum 2015-2016, TABLET, CHEWABLE ORAL 20161115 UNAPPROVED HOMEOPATHIC Source Naturals, Inc. ECHINACEA ANGUSTIFOLIA; ONION; BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; SANGUINARIA CANADENSIS ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; POTASSIUM DICHROMATE; PHOSPHORUS; ACONITUM NAPELLUS; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 3; 4; 4; 4; 4; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 64471-185_567f8229-f7e2-415b-b687-7769befa0f92 64471-185 HUMAN OTC DRUG Wellness with Cherry Flavor Cough Syrup Althaea officinalis, Prunus virginiana, Inula helenium SYRUP ORAL 20131016 UNAPPROVED HOMEOPATHIC Source Naturals ALTHAEA OFFICINALIS ROOT; PRUNUS VIRGINIANA BARK; INULA HELENIUM ROOT; MARRUBIUM VULGARE; EUCALYPTUS GLOBULUS LEAF; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; BRYONIA ALBA WHOLE; CAUSTICUM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; ANEMONE NEMOROSA 1; 1; 3; 3; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL E 20171231 64471-196_f65bbcbd-277c-401d-b25c-fef2fa299f13 64471-196 HUMAN OTC DRUG Allercetin Euphrasia Officinalis, Kali Iodatum, Sabadilla, Sticta Pulmonaria, Histaminum Hydrochloricum, Quercetin, Succinicum Acidum, Ambrosia Artemisiaefolia TABLET, CHEWABLE ORAL 20140905 UNAPPROVED HOMEOPATHIC Source Naturals, Inc. EUPHRASIA STRICTA; POTASSIUM IODIDE; SCHOENOCAULON OFFICINALE SEED; LOBARIA PULMONARIA; HISTAMINE DIHYDROCHLORIDE; QUERCETIN; SUCCINIC ACID; AMBROSIA ARTEMISIIFOLIA 6; 6; 6; 6; 12; 12; 12; 30 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg N 20181231 64471-214_de7fabc4-312b-42b1-b20d-6a3beeea3cd7 64471-214 HUMAN OTC DRUG Flu Guard Aconitum Napellus, Arsenicum Iodatum, Bryonia Alba, Eupatorium Perfoliatum, Gelsemium Sempervirens, Helix Tosta, Hydrogen, Influenzinum, Kreosotum, Phosphorus, Teucrium Scorodonia, Thuja Occidentalis, Veratrum Viride, Anas Barbariae PELLET ORAL 20150911 20200408 UNAPPROVED HOMEOPATHIC Source Naturals, Inc. ACONITUM NAPELLUS; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ESCARGOT SHELL, COOKED; HYDROGEN; INFLUENZA A VIRUS; INFLUENZA B VIRUS; WOOD CREOSOTE; PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200 [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g N 20181231 64471-247_30afd3e6-9b74-4828-a3b2-29bf25357a6c 64471-247 HUMAN OTC DRUG Flu Guard Aconitum Napellus, Arsenicum Iodatum, Bryonia (Alba), Eupatorium Perfoliatum, Gelsemium Sempervirens, Helix Tosta, Hydrogen, Influenzinum 2015-2016, Kreosotum, Phosphorus, Teucrium Scorodonia, Thuja Occidentalis, Veratrum Viride, Anas Barbariae, Hepatis Et Cordis Extractum PELLET ORAL 20150405 UNAPPROVED HOMEOPATHIC Source Naturals, Inc. ACONITUM NAPELLUS; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; ESCARGOT SHELL, COOKED; HYDROGEN; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); WOOD CREOSOTE; PHOSPHORUS; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM VIRIDE ROOT; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200 [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; 1/g; [hp_C]/g; 1/g; [hp_C]/g; 1/g; [kp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g N 20181231 64471-263_65364b1b-f7dd-41ad-9e55-53a2795cd312 64471-263 HUMAN OTC DRUG Wellness Earache Capsicum Annuum, Silicea, Verbascum Thapsus, Ferrum Phosphoricum, Kali Muriaticum, Aconitum Napellus, Belladonna, Calcarea Carbonica, Pulsatilla (Pratensis) TABLET, CHEWABLE ORAL 20161117 UNAPPROVED HOMEOPATHIC Source Naturals, Inc. CAPSICUM; SILICON DIOXIDE; VERBASCUM THAPSUS; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE; ACONITUM NAPELLUS; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA PRATENSIS 6; 6; 6; 12; 12; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 64471-330_40127dad-a783-4e4a-a5ce-042c8ea6aafb 64471-330 HUMAN OTC DRUG Wellness4Cough Syrup Cough Syrup Althaea officinalis, Prunus virginiana, Inula helenium SYRUP ORAL 20131016 UNAPPROVED HOMEOPATHIC Source Naturals ALTHAEA OFFICINALIS ROOT; PRUNUS VIRGINIANA BARK; INULA HELENIUM ROOT; MARRUBIUM VULGARE; EUCALYPTUS GLOBULUS LEAF; RUMEX CRISPUS ROOT; SANGUINARIA CANADENSIS ROOT; BRYONIA ALBA WHOLE; CAUSTICUM; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS 1; 1; 3; 3; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL E 20171231 64471-807_c2b63d18-cee5-450e-9d04-76d62a3078b1 64471-807 HUMAN OTC DRUG Migraine Blocker Chamomilla, Bryonia (Alba), Iris Versicolor, Juglans Cinerea, Pulsatilla (Pratensis), Sanguinaria Canadensis, Magnesia Muriatica, Natrum Muriaticum, Phosphorus, Silicea, Zincum Metallicum, Belladonna, Gelsemium Sempervirens, Ignatia Amara, Scutellaria Lateriflora TABLET, CHEWABLE ORAL 20161118 UNAPPROVED HOMEOPATHIC Source Naturals, Inc. MATRICARIA RECUTITA; BRYONIA ALBA ROOT; IRIS VERSICOLOR ROOT; JUGLANS CINEREA BRANCH BARK/ROOT BARK; PULSATILLA PRATENSIS; SANGUINARIA CANADENSIS ROOT; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; PHOSPHORUS; SILICON DIOXIDE; ZINC; ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; SCUTELLARIA LATERIFLORA 4; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 64477-001_a0ac7086-462d-4768-865e-89d00c3424cd 64477-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980305 UNAPPROVED MEDICAL GAS S & S Drug Inc. OXYGEN 99 L/100L E 20171231 64481-0001_dd139f52-a647-4b74-919d-275441dee9bd 64481-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Life Quality Home Healthcare, Inc. OXYGEN 99 L/100L E 20171231 64483-001_2406c6cd-654d-43a0-b062-e321939c25be 64483-001 HUMAN OTC DRUG Elastology Age Blocker Octinoxate, Octisalate, Titanium dioxide, and Oxybenzone CREAM TOPICAL 20000815 OTC MONOGRAPH NOT FINAL part352 Clientele, Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; OXYBENZONE 7; 2; 1.5; 3 g/100g; g/100g; g/100g; g/100g E 20171231 64483-003_e00e579f-8746-4bb9-b774-07117cc12d55 64483-003 HUMAN OTC DRUG Estro-Lift Day Therapy Octinoxate, Octisalate, Titanium dioxide, and Oxybenzone CREAM TOPICAL 20000815 OTC MONOGRAPH NOT FINAL part352 Clientele, Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; OXYBENZONE 7; 2; 1.5; 3 g/100g; g/100g; g/100g; g/100g E 20171231 64483-007_6e942baa-cce1-43cd-ab4a-dc24d39ac9e1 64483-007 HUMAN OTC DRUG Power Relief Menthol GEL TOPICAL 20040402 OTC MONOGRAPH NOT FINAL part348 Clientele, Inc. MENTHOL 2 mL/100mL E 20171231 64495-2362_5f1399de-c671-42ae-be9d-29b06515c2f2 64495-2362 HUMAN OTC DRUG Bac Off Benzalkonium Chloride LIQUID TOPICAL 20080331 OTC MONOGRAPH NOT FINAL part333 Wayne Concept Manufacturing Co Inc BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 64495-2363_dcb7d8da-afcf-4b9d-8c99-4974167f2beb 64495-2363 HUMAN OTC DRUG Bac Stop Benzalkonium Chloride LIQUID TOPICAL 20091031 OTC MONOGRAPH NOT FINAL part333 Wayne Concept Manufacturing Co Inc BENZALKONIUM CHLORIDE .13 mL/100mL N 20181231 64495-2364_1c613209-3154-472e-b3b9-0ce2293ab893 64495-2364 HUMAN OTC DRUG Count Down CHLOROXYLENOL LIQUID TOPICAL 20110509 OTC MONOGRAPH NOT FINAL part333A Wayne Concept Manufacturing Co Inc CHLOROXYLENOL .3 mL/100mL N 20181231 64495-2365_0edf7cb6-36b7-4297-ad62-65b814e739a3 64495-2365 HUMAN OTC DRUG BAC OFF BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120330 OTC MONOGRAPH NOT FINAL part333A Wayne Concept Manufacturing Co Inc BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 64495-2366_2df3d2f3-3627-4e93-aad4-a56ecdb2d028 64495-2366 HUMAN OTC DRUG Bac Stop BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120330 OTC MONOGRAPH NOT FINAL part333A Wayne Concept Manufacturing Co Inc BENZALKONIUM CHLORIDE .13 mL/100mL N 20181231 64495-2367_c1fcb3e4-08cc-4e9e-909b-aa8ff7348c22 64495-2367 HUMAN OTC DRUG Clear Bac CHLOROXYLENOL LIQUID TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part333A Wayne Concept Manufacturing Co Inc CHLOROXYLENOL .5 mL/100mL N 20181231 64525-0542_4dbfa304-eb0f-4124-854d-a8da9b7710d4 64525-0542 HUMAN OTC DRUG Walgreens night time wal-flu severe cold and cough honey lemon flavor infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0543_23d8e934-b718-4b2b-9a4e-f0f227d3dbd9 64525-0543 HUMAN OTC DRUG CVS day time cough and severe cold berry infused with menthol and green tea flavors Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 64525-0544_6503ed4b-1640-45af-878f-bf4834903c09 64525-0544 HUMAN OTC DRUG CVS cough and severe cold night time honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0545_8189f7ee-2412-49b9-8105-238ef9216e9f 64525-0545 HUMAN OTC DRUG Our Family day time severe cold and Cough berry infused with menthol and green tea flavors Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 64525-0546_825509dc-274c-48e7-ab8c-dc6de9a38617 64525-0546 HUMAN OTC DRUG Our Family night time severe cold and cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0547_3ac9cb51-d6cc-4055-9dd6-1d8df9838644 64525-0547 HUMAN OTC DRUG Premier Value day time severe cold and cough berry infused with menthol and green tea flavors Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 64525-0548_4a00b112-c0dd-4085-9670-77bc63516568 64525-0548 HUMAN OTC DRUG Premier Value night time severe cold and cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0549_35b034c1-20c3-493f-9080-c65e1de5f365 64525-0549 HUMAN OTC DRUG Quality Choice day time severe cold and cough berry infused with menthol and green tea flavors Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 64525-0550_18184660-5a94-4382-88ae-57b03173da09 64525-0550 HUMAN OTC DRUG Quality Choice night time severe cold and cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0551_e6568ab9-b334-490f-b01d-64547dbae26f 64525-0551 HUMAN OTC DRUG Rite Aid day time severe cold and cough berry infused with menthol and green tea flavors Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 64525-0552_72d505db-2455-40bd-80a8-3fbd549e2a4d 64525-0552 HUMAN OTC DRUG Rite Aid night time severe cold and cough honey lemon with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0553_4e9e2353-9dc4-4365-a225-2aa983f797f8 64525-0553 HUMAN OTC DRUG TopCare day time severe cold and cough berry infused with menthol and green tea flavors Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 64525-0554_9185baab-1335-465a-b506-1edf485358b3 64525-0554 HUMAN OTC DRUG TopCare night time severe cold and cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20091031 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0555_2cee75fb-271f-5272-e054-00144ff8d46c 64525-0555 HUMAN OTC DRUG Meijer Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20130930 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 64525-0556_28c5511e-41e6-34bd-e054-00144ff88e88 64525-0556 HUMAN OTC DRUG Careone night time severe cold and cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenyleprine HCL. GRANULE, FOR SOLUTION ORAL 20131024 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0557_270a6b5f-39d8-0bf5-e054-00144ff88e88 64525-0557 HUMAN OTC DRUG Best Choice Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20131030 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 64525-0558_2cef0c70-6f6a-5032-e054-00144ff8d46c 64525-0558 HUMAN OTC DRUG Meijer Nighttime Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea Flavors Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20130927 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0559_27085794-ae3d-6faf-e054-00144ff8d46c 64525-0559 HUMAN OTC DRUG Western Family Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20150604 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 64525-0560_2cef411f-d83c-0e79-e054-00144ff8d46c 64525-0560 HUMAN OTC DRUG Smart sense Nighttime Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea Flavors Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20131119 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0562_27099e50-722b-41a8-e054-00144ff8d46c 64525-0562 HUMAN OTC DRUG Best Choice Nighttime Severe Cold and Cough Honey Lemon infused with Chamomile and White Tea Flavors Acetaminophen, Diphenhydramine HCl and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20131119 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0564_2706fa88-618e-25ff-e054-00144ff8d46c 64525-0564 HUMAN OTC DRUG Western Family Nighttime Severe Cold and Cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20150604 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0566_4fe2cf36-624d-12ef-e054-00144ff88e88 64525-0566 HUMAN OTC DRUG Family Dollar Nighttime Severe Cold and Cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20151124 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 64525-0601_2cee69a5-5729-1daa-e054-00144ff88e88 64525-0601 HUMAN OTC DRUG Meijer Multi-Symptom Severe Cold Green Tea and Honey Lemon flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20150104 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 64525-0603_4fd2834c-a34c-1a03-e054-00144ff88e88 64525-0603 HUMAN OTC DRUG Family Dollar Multi-Symptom Severe Cold Green Tea and Honey Lemon flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20151123 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 64525-0701_6f046ff7-3b5a-4acf-86ec-c78cba4ec9e8 64525-0701 HUMAN OTC DRUG TopCare Cold and Sore Throat Lemon Flavor Acetaminophen, Pheniramine Maleate, Phenylephrine HCl GRANULE, FOR SOLUTION ORAL 20130926 OTC MONOGRAPH FINAL part341 Quality Home Products ACETAMINOPHEN; PHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 20; 10 mg/1; mg/1; mg/1 N 20181231 64525-5131_82cb7042-2c4c-43bc-84e7-b4f1f1294be6 64525-5131 HUMAN OTC DRUG QC Cold and Hot Pain Relief Menthol PATCH TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part348 Quality Home Products MENTHOL 400 mg/1 E 20171231 64525-5382_d66a67f2-678d-402a-92ad-c08b83ec8a5f 64525-5382 HUMAN OTC DRUG QC Diaper Rash Zinc Oxide CREAM TOPICAL 20110912 OTC MONOGRAPH FINAL part347 Quality Home Products ZINC OXIDE .1 g/g E 20171231 64525-5565_ce7db22a-c116-4003-b991-63bd1f4689b9 64525-5565 HUMAN OTC DRUG Quality Choice Muscle and Joint Menthol GEL TOPICAL 20110916 OTC MONOGRAPH NOT FINAL part348 Quality Home Products MENTHOL 2.5 g/100g E 20171231 64525-7000_48b667ac-143a-6324-88e1-57e2f0b5ef89 64525-7000 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160916 ANDA ANDA208150 Quality Home Products FLUTICASONE PROPIONATE 50 ug/1 N 20181231 64533-000_7bf5069b-3d80-4018-8297-ee4f73f67b39 64533-000 HUMAN OTC DRUG LidAll Lidocaine PATCH TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 MedVantage Pharmaceutical, LLC LIDOCAINE; MENTHOL 4; 1 g/100g; g/100g E 20171231 64536-0114_6a4ab3c7-8a15-4488-be94-8b320d086832 64536-0114 HUMAN OTC DRUG Soft Care Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20140822 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 67.6 L/100L N 20181231 64536-0807_cdd555f9-4e07-4278-8dc5-4a221161cc4c 64536-0807 HUMAN OTC DRUG Soft Care Foaming Antibacterial Hand Triclosan LIQUID TOPICAL 20101012 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .5 mL/100mL E 20171231 64536-1140_edfb603e-9b3d-436b-9bea-a6e3899689d5 64536-1140 HUMAN OTC DRUG Soft Care Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20140807 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 67.6 mL/100mL N 20181231 64536-1268_d4a9ff51-aa1e-43e5-a63e-022d170060a3 64536-1268 HUMAN OTC DRUG Soft Care Foaming Instant Hand Sanitizer Benzethonium Chloride LIQUID TOPICAL 20101011 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. BENZETHONIUM CHLORIDE .2 mL/100mL E 20171231 64536-1269_3876b4e6-f3d0-436d-9177-e265f40ca42b 64536-1269 HUMAN OTC DRUG Soft Care Hand Sanitizer Alcohol GEL TOPICAL 20101013 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 62 mL/100mL E 20171231 64536-1271_1f34a03d-e484-48c7-bf45-27dc86513ee0 64536-1271 HUMAN OTC DRUG Soft Care Antibacterial-Antiseptic Hand CHLOROXYLENOL LIQUID TOPICAL 20101014 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. CHLOROXYLENOL .3 mL/100mL E 20171231 64536-1406_54c39ee4-c809-42b0-a2f0-477eddc19832 64536-1406 HUMAN OTC DRUG Soft Care Hand Sanitizing Wipe Alcohol Free BENZALKONIUM CHLORIDE LIQUID TOPICAL 20150416 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. BENZALKONIUM CHLORIDE .12 g/100mL N 20181231 64536-1565_e97bf400-3f21-4c12-af19-9fc3db770dd1 64536-1565 HUMAN OTC DRUG Soft Care Impact Mini Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20160629 OTC MONOGRAPH NOT FINAL part333E Diversey. Inc. ALCOHOL 70 mL/100mL N 20181231 64536-2220_c5d50d15-5856-454a-881c-fb392ea0e0c8 64536-2220 HUMAN OTC DRUG Soft Care Foam Select Antibacterial Triclosan TRICLOSAN LIQUID TOPICAL 20140814 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .5 g/100mL E 20171231 64536-2222_26c80f1e-cffc-444b-9e65-089033985b51 64536-2222 HUMAN OTC DRUG Soft Care Foam Select Antibacterial Hand Triclosan LIQUID TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .5 g/100mL E 20171231 64536-3628_8c866f80-2572-4652-af77-b898dcdd4ee0 64536-3628 HUMAN OTC DRUG Soft Care Instant Hand Sanitizer AF BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20170414 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 64536-3851_f8acfc75-03a3-4867-a151-df1f563246d8 64536-3851 HUMAN OTC DRUG Soft Care Foam Antibacterial Hand Soap Triclosan LIQUID TOPICAL 20100430 OTC MONOGRAPH NOT FINAL part333 Johnson Diversey, Inc. TRICLOSAN .5 mL/100mL E 20171231 64536-4350_fbd9b44b-e159-48c2-aa89-d0e1f59d1446 64536-4350 HUMAN OTC DRUG Soft Care Neutra Germ Antibacterial Triclosan LIQUID TOPICAL 20130615 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .55 g/100mL E 20171231 64536-4351_69bb1b6c-5958-4438-a5ec-7cc49b632954 64536-4351 HUMAN OTC DRUG Soft Care Neutra Germ Antibacterial Triclosan LIQUID TOPICAL 20130615 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .55 g/100mL E 20171231 64536-5471_d427b88e-ad12-4f81-bdbc-bb47c7d9c857 64536-5471 HUMAN OTC DRUG Soft Care Antiseptic Skin Cleanser Chloroxylenol LIQUID TOPICAL 20130615 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. CHLOROXYLENOL 1 g/100mL E 20171231 64536-6102_374c96a1-7a1d-4d90-a5ec-2a5aec7f107f 64536-6102 HUMAN OTC DRUG Lever 2000 Antibacterial Triclosan LIQUID TOPICAL 20070927 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .25 g/100mL E 20171231 64536-6618_9cd6b85a-c0e7-4d8f-ae88-1a2efa9abbdb 64536-6618 HUMAN OTC DRUG Soft Care Impact Alcohol Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20160812 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 76 L/100L N 20181231 64536-7090_8ec2670f-f7de-46a5-9e40-028ea8e66965 64536-7090 HUMAN OTC DRUG Soft Care Antiseptic Skin Cleanser II TRICLOSAN LIQUID TOPICAL 20140609 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .55 g/100mL E 20171231 64536-7271_be7f42aa-910f-4822-a332-72252dadd8e4 64536-7271 HUMAN OTC DRUG Soft Care Foam Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141122 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 62 L/100L E 20171231 64536-7291_d35fbabb-bed3-4dc4-9dd5-cc60fc10216a 64536-7291 HUMAN OTC DRUG Soft Care Foam Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20160802 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 62 L/100L N 20181231 64536-7295_f6d504d1-5c3f-4533-a819-08923c3f1ab6 64536-7295 HUMAN OTC DRUG Soft Care Foam Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 62 mL/100mL N 20181231 64536-7873_f6b1cfe6-9289-4c68-80c5-70bf04179aef 64536-7873 HUMAN OTC DRUG Soft Care Neutra Germ Fragrance Free Antibacterial Triclosan LIQUID TOPICAL 20130315 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN 5.5 g/L E 20171231 64536-8068_f48da7bb-42b2-4910-b175-5f224d6ce3c6 64536-8068 HUMAN OTC DRUG Soft Care Impact Foam Alcohol Foam Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20160815 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 76 L/100L N 20181231 64536-8308_4a5f319e-68c9-47b8-b9ea-247f4e660c08 64536-8308 HUMAN OTC DRUG Soft Care Defend Foam Antibacterial Handwash Chloroxylenol SOLUTION TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. CHLOROXYLENOL 1 g/100mL N 20181231 64536-8398_d8264d55-8279-440e-804b-d295c8cc9e05 64536-8398 HUMAN OTC DRUG Soft Care Impact Alcohol Fee Instant Hand Sanitizer BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20160914 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. BENZALKONIUM CHLORIDE .13 g/100mL E 20171231 64536-8511_8c96bb52-a165-4734-a02d-55b5c39b1447 64536-8511 HUMAN OTC DRUG Soft Care Foam Antibacterial Hand TRICLOSAN LIQUID TOPICAL 20141122 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN 5 g/L N 20181231 64536-8730_4a6e3069-05af-4859-b861-e10801758c2d 64536-8730 HUMAN OTC DRUG Soft Care Neutra Germ Fragrance Free Antibacterial Triclosan LIQUID TOPICAL 20130615 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN 5.5 g/L E 20171231 64536-8731_5fc76de6-0ac2-4f4b-919e-27cbb6097386 64536-8731 HUMAN OTC DRUG Soft Care Neutra Germ Fragrance Free Antibacterial Triclosan LIQUID TOPICAL 20130615 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN .55 g/100mL E 20171231 64536-8740_1ac7fb12-b9af-49c1-b315-c0b5ad6051fb 64536-8740 HUMAN OTC DRUG Soft Care Neutra-Germ Antibacterial Fragrance Free Triclosan LIQUID TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. TRICLOSAN 5.5 g/L E 20171231 64536-8741_a6b45226-2ac9-4a87-9b35-182118cee732 64536-8741 HUMAN OTC DRUG Soft Care Neutra-Germ Antibacterial Fragrance Free TRICLOSAN LIQUID TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part333A Diversey, INC TRICLOSAN 5.5 g/L E 20171231 64536-8748_1a900806-fb8a-490a-8c5d-966cccc4d9ce 64536-8748 HUMAN OTC DRUG Soft Care Defend Antibacterial Handwash Choroxylenol SOLUTION TOPICAL 20160606 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. CHLOROXYLENOL 1 g/100mL N 20181231 64536-8760_60c65f7f-665c-425f-a8ed-d659d409604c 64536-8760 HUMAN OTC DRUG Soft Care Defend Antibacterial Handwash Chloroxylenol SOLUTION TOPICAL 20160718 OTC MONOGRAPH NOT FINAL part333A Diversey, Inc. CHLOROXYLENOL 10 g/L N 20181231 64536-8920_564e1f04-7646-40df-9ddb-a6955ffa07d7 64536-8920 HUMAN OTC DRUG Soft Care Fragrance Free Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141122 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 62 L/100L N 20181231 64536-8921_c77e087b-2a82-44d4-9de3-aee2f36abcdb 64536-8921 HUMAN OTC DRUG Soft Care Fragrance Free Instant Hand Sanitizer ALCOHOL LIQUID TOPICAL 20141122 OTC MONOGRAPH NOT FINAL part333E Diversey, Inc. ALCOHOL 62 L/100L E 20171231 64539-003_4ef54518-1fce-4c71-e054-00144ff8d46c 64539-003 HUMAN OTC DRUG Glyzigen Gel Intimate Glycerin GEL TOPICAL 20170507 OTC MONOGRAPH FINAL part347 Catalysis, SL GLYCERIN .5 mg/mL N 20181231 64539-004_530af5d6-debd-487a-e054-00144ff8d46c 64539-004 HUMAN OTC DRUG Glizigen Skin Protectant Glycerin SPRAY TOPICAL 20170507 OTC MONOGRAPH FINAL part347 Catalysis, SL GLYCERIN .5 mg/mL N 20181231 64539-005_530b1834-7524-39c4-e054-00144ff8d46c 64539-005 HUMAN OTC DRUG Cicatrix Skin Protectant Glycerin CREAM TOPICAL 20170502 OTC MONOGRAPH FINAL part347 Catalysis, SL GLYCERIN 3 mg/mL N 20181231 64539-006_530b8dc2-7ef3-61a1-e054-00144ff88e88 64539-006 HUMAN OTC DRUG Cicatrix Skin Protectant Glycerin CREAM TOPICAL 20170502 OTC MONOGRAPH FINAL part347 Catalysis, SL GLYCERIN 3 mg/mL N 20181231 64539-007_628d633c-6f69-e9d1-e053-2991aa0a2986 64539-007 HUMAN OTC DRUG Glyzigen Single Dose Intimate Gel Glycerin GEL TOPICAL 20180111 OTC MONOGRAPH FINAL part347 Catalysis, SL GLYCERIN .5 mg/mL N 20191231 64539-008_62b5342d-5f53-43c7-e053-2991aa0a92d7 64539-008 HUMAN OTC DRUG Granex Foam Acne Treatment Salicylic Acid AEROSOL, FOAM TOPICAL 20180111 OTC MONOGRAPH FINAL part333D Catalysis, SL SALICYLIC ACID .7 mg/mL N 20191231 64539-011_63de8c3b-10ec-20d4-e053-2991aa0ad32b 64539-011 HUMAN OTC DRUG Cicatrix Skin Protectant Glycerin CREAM TOPICAL 20180128 OTC MONOGRAPH FINAL part347 Catalysis, SL GLYCERIN 3 mg/mL N 20191231 64540-001_8129b1f4-9d94-41a9-b40a-2358bd15cb21 64540-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20110711 UNAPPROVED MEDICAL GAS Austin Respiratory Equipment,inc. OXYGEN 990 mL/L N 20181231 64540-011_206f040f-3e08-4ffa-9e88-288fd112fb8a 64540-011 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 20110711 UNAPPROVED MEDICAL GAS Austin Respiratory Equipment,inc OXYGEN 990 mL/L N 20181231 64543-044_5b465f0a-9b61-3e80-e053-2a91aa0a6ec4 64543-044 HUMAN OTC DRUG Rescon GG Guaifenesin and Phenylephrine Hydrochloride LIQUID ORAL 19990101 OTC MONOGRAPH FINAL part341 Capellon Pharmaceuticals, LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 100; 5 mg/5mL; mg/5mL N 20181231 64543-097_5b47cc0e-3d8d-e03b-e053-2a91aa0a6e7f 64543-097 HUMAN OTC DRUG Rescon Dexchlorpheniramine Maleate and Pseudoephedrine Hydrochloride TABLET, MULTILAYER ORAL 20120330 OTC MONOGRAPH FINAL part341 Capellon Pharmaceuticals, LLC DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 60 mg/1; mg/1 N 20181231 64543-105_5b38c7e1-20dc-21a9-e053-2991aa0a5d1b 64543-105 HUMAN OTC DRUG Rescon DM Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Pseudoephedrine Hydrochloride LIQUID ORAL 19990101 OTC MONOGRAPH FINAL part341 Capellon Pharmaceuticals, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 10; 30 mg/5mL; mg/5mL; mg/5mL N 20181231 64543-111_5b48d72a-965d-df97-e053-2991aa0a972d 64543-111 HUMAN PRESCRIPTION DRUG Symax SL Hyoscyamine Sulfate TABLET, ORALLY DISINTEGRATING ORAL 19960901 UNAPPROVED DRUG OTHER Capellon Pharmaceuticals, LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 64543-112_5b491bb6-435e-3201-e053-2991aa0a4bf1 64543-112 HUMAN PRESCRIPTION DRUG Symax SR Hyoscyamine Sulfate TABLET, EXTENDED RELEASE ORAL 20091107 UNAPPROVED DRUG OTHER Capellon Pharmaceuticals, LLC HYOSCYAMINE SULFATE .375 mg/1 N 20181231 64543-118_5b488d03-ab80-3a2e-e053-2a91aa0a7f65 64543-118 HUMAN PRESCRIPTION DRUG Symax Duotab Hyoscyamine Sulfate TABLET, MULTILAYER, EXTENDED RELEASE ORAL 20091107 UNAPPROVED DRUG OTHER Capellon Pharmaceuticals, LLC HYOSCYAMINE SULFATE .375 mg/1 N 20181231 64545-0001_278685ee-49c9-46bb-8607-4f9891bb5f01 64545-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040516 UNAPPROVED MEDICAL GAS P & R Home IV Service OXYGEN 99 L/100L E 20171231 64578-0055_6a481836-73ff-4591-ab8a-3cce1630429c 64578-0055 HUMAN OTC DRUG Agri-Chord Arsenicum Album, Belladonna, Calcarea Carbonica, Ceanothus Americanus, Chelidonium Majus, Cuprum Sulphuricum, Fumaricum Acidum, Galium Aparine, Glandula Suprarenalis Suis, Hepar Suis, Kali Iodatum, Lycopodium Clavatum, Pancreas Suis, Petroleum, Phosphoricum Acidum, Phosphorus, Phytolacca Decandra, Sarsaparilla (Smilax Regelii), Silicea, Sulphur, Thyroidinum (Bovine), Trifolium Pratense, Xanthoxylum Fraxineum, Zincum Phosphoratum LIQUID ORAL 20141117 UNAPPROVED HOMEOPATHIC Energetix Corp ARSENIC TRIOXIDE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CUPRIC SULFATE; FUMARIC ACID; GALIUM APARINE; SUS SCROFA ADRENAL GLAND; PORK LIVER; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; SUS SCROFA PANCREAS; KEROSENE; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SMILAX REGELII ROOT; SILICON DIOXIDE; SULFUR; THYROID, BOVINE; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ZINC PHOSPHIDE 12; 12; 30; 6; 12; 30; 30; 6; 9; 9; 30; 12; 9; 30; 12; 30; 4; 12; 30; 30; 9; 4; 4; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0056_05078116-2b4d-4b25-b242-306d4afd9d8e 64578-0056 HUMAN OTC DRUG Aller-Chord Food Homeopathic Liquid LIQUID ORAL 20140808 UNAPPROVED HOMEOPATHIC Energetix Corp ACETALDEHYDE; SUS SCROFA ADRENAL GLAND; SILVER NITRATE; CORTISONE ACETATE; GALLIC ACID MONOHYDRATE; HISTAMINE DIHYDROCHLORIDE; ECHINACEA PURPUREA; HYDRANGEA ARBORESCENS ROOT; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ACETIC ACID; CAFFEINE; CALCIUM SULFATE ANHYDROUS; ANHYDROUS CITRIC ACID; FUMARIC ACID; COW MILK; EGG PHOSPHOLIPIDS; SODIUM BICARBONATE; SUCROSE; TARTARIC ACID; SACCHAROMYCES CEREVISIAE; SODIUM CHLORIDE; PARAFFIN; ESTRONE; PHOSPHORIC ACID; ALPINE STRAWBERRY; LIMULUS POLYPHEMUS; SOLANUM LYCOPERSICUM; SILICON DIOXIDE 12; 9; 10; 20; 12; 12; 6; 6; 9; 12; 12; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 12; 15; 15; 15; 15; 15; 15; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL E 20171231 64578-0057_3453739b-10ae-41a1-bb92-af0f8753433e 64578-0057 HUMAN OTC DRUG Aller-Chord A Alfalfa, Allium Cepa, Ambrosia Artemisiaefolia, Bryonia (Alba), Citricum Acidum, Coumarinum, Euphrasia Officinalis, Glandula Suprarenalis Suis, Hepar Suis, Histaminum Hydrochloricum, Hydrastis Canadensis, Juniperus Communis, Mucosa Nasalis Suis, Natrum Sulphuricum, Phosphorus, Pothos Foetidus, Pulsatilla (Vulgaris), Solidago Virgaurea, Sulphur, Tanacetum Vulgare, Taraxacum Officinale, Trifolium Pratense LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Energetix Corp ALFALFA; ONION; AMBROSIA ARTEMISIIFOLIA; BRYONIA ALBA ROOT; ANHYDROUS CITRIC ACID; COUMARIN; EUPHRASIA STRICTA; SUS SCROFA ADRENAL GLAND; PORK LIVER; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; JUNIPER BERRY; SUS SCROFA NASAL MUCOSA; SODIUM SULFATE; PHOSPHORUS; SYMPLOCARPUS FOETIDUS ROOT; PULSATILLA VULGARIS; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR; TANACETUM VULGARE TOP; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER 9; 6; 6; 6; 12; 12; 6; 9; 9; 12; 9; 9; 9; 12; 12; 9; 12; 9; 12; 9; 9; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0058_f32b462f-c390-4f7f-9de8-f43cd07b8f31 64578-0058 HUMAN OTC DRUG Amoeba-Chord Absinthium, Baptisia Tinctoria, Cajuputum, Capsicum Annuum, Cinchona Officinalis, Fragaria Vesca, Gentiana Lutea, Glandula Suprarenalis Suis, Hepar Suis, Lycopodium Clavatum, Mucosa Nasalis Suis, Nux Vomica, Pancreas Suis, Pulsatilla, Pyrogenium, Quassia, Senna, Triticum Repens LIQUID ORAL 20141022 UNAPPROVED HOMEOPATHIC Energetix Corp WORMWOOD; BAPTISIA TINCTORIA ROOT; CAJUPUT OIL; CAPSICUM; CINCHONA OFFICINALIS BARK; ALPINE STRAWBERRY; GENTIANA LUTEA ROOT; SUS SCROFA ADRENAL GLAND; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; SUS SCROFA NASAL MUCOSA; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; PULSATILLA VULGARIS; RANCID BEEF; QUASSIA AMARA WOOD; SENNA LEAF; ELYMUS REPENS ROOT 6; 4; 6; 5; 12; 4; 6; 9; 9; 12; 9; 12; 9; 12; 30; 4; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0059_415652d6-ba52-4a27-ab21-1516c1fea95a 64578-0059 HUMAN OTC DRUG Bacteria-Chord Azadirachta Indica, Belladonna, Berberis Vulgaris, Boldo, Candida Albicans, Ceanothus Americanus, Cetraria Islandica, Crotalus Horridus, Echinacea (Angustifolia), Glandula Suprarenalis Suis, Glycyrrhiza Glabra, Hamamelis Virginiana, Hepar Suis, Hydrastis Canadensis, Hydrocotyle Asiatica, Hypericum Perforatum, Lappa Major, Ledum Palustre, Millefolium, Morbillinum, Myrrha, Pancreas Suis, Pertussinum, Phosphorus, Plantago Major, Pyrogenium, Solidago Virgaurea, Zingiber Officinale LIQUID ORAL 20140307 20210727 UNAPPROVED HOMEOPATHIC Energetix Corp AZADIRACHTA INDICA BARK; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; PEUMUS BOLDUS LEAF; CANDIDA ALBICANS; CEANOTHUS AMERICANUS LEAF; CETRARIA ISLANDICA SUBSP. ISLANDICA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; SUS SCROFA ADRENAL GLAND; GLYCYRRHIZA GLABRA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; GOLDENSEAL; CENTELLA ASIATICA; HYPERICUM PERFORATUM; ARCTIUM LAPPA ROOT; LEDUM PALUSTRE TWIG; ACHILLEA MILLEFOLIUM; MEASLES VIRUS; MYRRH; SUS SCROFA PANCREAS; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; PHOSPHORUS; PLANTAGO MAJOR; RANCID BEEF; SOLIDAGO VIRGAUREA FLOWERING TOP; GINGER 8; 8; 9; 4; 30; 4; 12; 12; 4; 9; 4; 6; 9; 4; 6; 12; 4; 9; 12; 30; 4; 9; 30; 12; 4; 30; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0060_4938e905-49a1-4d4b-901e-e287ca2907b2 64578-0060 HUMAN OTC DRUG Medi-Chord Homeopathic Liquid LIQUID ORAL 20170921 UNAPPROVED HOMEOPATHIC Energetix Corporation ACETIC ACID; ASPIRIN; CORTICOTROPIN HUMAN; ALUMINUM; ATROPA BELLADONNA; BENZENE; CHLORAMPHENICOL; CHLORPROMAZINE; CORTISONE ACETATE; ESTRONE; SUS SCROFA ADRENAL GLAND; GLYCYRRHIZA GLABRA; PORK LIVER; POTASSIUM IODIDE; ARCTIUM LAPPA ROOT; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHENACETIN; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; LEAD; FRANGULA PURSHIANA BARK; PHENYL SALICYLATE; SARSAPARILLA; THYROID, UNSPECIFIED; TRIFOLIUM PRATENSE FLOWER; ELYMUS REPENS ROOT 18; 18; 18; 18; 12; 12; 18; 18; 18; 18; 9; 4; 9; 12; 4; 12; 12; 12; 18; 18; 12; 4; 15; 4; 18; 4; 9; 4; 4 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0061_3b0e01ab-8ef2-43bd-90ea-c0253b68d129 64578-0061 HUMAN OTC DRUG Colo-Chord Homeopathic Liquid LIQUID ORAL 20141008 UNAPPROVED HOMEOPATHIC Energetix Corp ABELMOSCHUS MOSCHATUS SEED; ARANEUS DIADEMATUS; ASAFETIDA; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; CANDIDA ALBICANS; ACTIVATED CHARCOAL; ESCHERICHIA COLI; BOS TAURUS COLOSTRUM; MARSDENIA CONDURANGO BARK; BOS TAURUS BILE; PORK LIVER; COW MILK; LYCOPODIUM CLAVATUM SPORE; MANDRAGORA OFFICINARUM ROOT; MERCURIUS SOLUBILIS; SUS SCROFA NASAL MUCOSA; FRANGULA PURSHIANA BARK; RHEUM OFFICINALE ROOT; SELENIUM; VERATRUM ALBUM ROOT 12; 12; 12; 30; 4; 18; 15; 24; 8; 12; 8; 9; 12; 12; 12; 12; 9; 4; 4; 15; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0062_659fd6a2-f6f3-45ff-b770-210d57485cdd 64578-0062 HUMAN OTC DRUG Dental-Chord Homeopathic Liquid LIQUID ORAL 20140904 UNAPPROVED HOMEOPATHIC Energetix Corp ACETIC ACID; AMMONIUM CHLORIDE; SILVER; GOLD; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; PHENOL; LEMON JUICE; COPPER; IRON; GLYCYRRHIZA GLABRA; ARCTIUM LAPPA ROOT; SUS SCROFA BONE MARROW; MERCURIUS SOLUBILIS; MYRRH; SODIUM FLUORIDE; PALLADIUM; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; SELENIUM; SILICON DIOXIDE; TIN; DELPHINIUM STAPHISAGRIA SEED; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE FLOWER; LACTOSE, X-RAY EXPOSED (1000 RAD); ZINC OXIDE 15; 15; 15; 15; 12; 12; 15; 12; 15; 12; 4; 4; 9; 12; 6; 12; 15; 15; 4; 15; 12; 15; 6; 4; 4; 30; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0063_08870ed2-27d2-4c97-adf7-c5c917ecb9d1 64578-0063 HUMAN OTC DRUG Gyne-Chord Homeopathic Liquid LIQUID ORAL 20170719 UNAPPROVED HOMEOPATHIC Energetix Corp ANGELICA SINENSIS ROOT; GOLD TRICHLORIDE; BORIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CANDIDA ALBICANS; BLACK COHOSH; ESTRONE; SUS SCROFA ADRENAL GLAND; CHAMAELIRIUM LUTEUM ROOT; GOLDENSEAL; WOOD CREOSOTE; MERCURIUS SOLUBILIS; SODIUM SULFATE; SUS SCROFA OVARY; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; ZINC GLUCONATE 8; 15; 12; 15; 12; 6; 7; 9; 12; 12; 15; 12; 12; 9; 12; 12; 12; 12; 9; 8 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0064_7484823e-15fd-49df-90f6-a466351df6cc 64578-0064 HUMAN OTC DRUG Hepata-Chord Homeopathic Liquid LIQUID ORAL 20141117 UNAPPROVED HOMEOPATHIC Energetix Corp ACETIC ACID; ASPIRIN; ALUMINUM OXIDE; BENZENE; BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; CHELONE GLABRA; CHLORAMPHENICOL; CHLORPROMAZINE; CHOLESTEROL; CORTISONE ACETATE; ESTRONE; GAMBOGE; PORK LIVER; CENTELLA ASIATICA; BOS TAURUS HYPOTHALAMUS; ARCTIUM LAPPA ROOT; SODIUM SULFATE; PARAFFIN; KEROSENE; PHENACETIN; PHOSPHORUS; SILICON DIOXIDE; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED 18; 18; 18; 12; 4; 4; 4; 12; 18; 18; 12; 18; 18; 12; 9; 5; 12; 4; 12; 18; 18; 18; 12; 12; 4; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0065_e7ef3e07-fbc1-4d53-a4ba-07c51c9c5fc0 64578-0065 HUMAN OTC DRUG HZ-Chord Baptisia Tinctoria, Ceanothus Americanus, Citricum Acidum, Echinacea (Angustifolia), Gelsemium Sempervirens, Hydrocotyle Asiatica, Lycopodium Clavatum, Mercurius Solubilis, Mezereum, Morbillinum, Nux Vomica, Paloondo, Phytolacca Decandra, Sepia, Thuja Occidentalis, Thyroidinum (Bovine) LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC Energetix Corp BAPTISIA TINCTORIA ROOT; CEANOTHUS AMERICANUS LEAF; ANHYDROUS CITRIC ACID; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; CENTELLA ASIATICA; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; MEASLES VIRUS; STRYCHNOS NUX-VOMICA SEED; LARREA TRIDENTATA TOP; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, BOVINE 4; 6; 12; 4; 12; 12; 12; 12; 12; 30; 12; 5; 4; 12; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0067_49f4ca9a-a6a8-4b53-929f-ab27bb191f31 64578-0067 HUMAN OTC DRUG Lipo-Chord Homeopathic Liquid LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC Energetix Corp ACETIC ACID; ASPIRIN; CORTICOTROPIN HUMAN; ALUMINUM OXIDE; ARSENIC TRIOXIDE; BORAGE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHLORAMPHENICOL; CHLORPROMAZINE; CHOLESTEROL; CORTISONE ACETATE; TURNERA DIFFUSA LEAFY TWIG; ESTRONE; FUMARIC ACID; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; COD LIVER OIL; KEROSENE; PHENACETIN; PHOSPHORIC ACID; PHOSPHORUS; LEAD; SUCROSE; SILICON DIOXIDE; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED 18; 18; 18; 18; 30; 4; 6; 12; 6; 18; 18; 12; 18; 12; 18; 30; 30; 30; 30; 30; 12; 18; 18; 30; 30; 30; 30; 30; 4; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL E 20171231 64578-0068_0596b78f-62dc-44a5-a6fd-9f9735d54e7c 64578-0068 HUMAN OTC DRUG Metal-Chord Allium Cepa, Allium Sativum, Alpha-Lipoicum Acidum, Alumina, Arsenicum Metallicum, Berberis Vulgaris, Cadmium Metallicum, Carduus Marianus, Cetraria Islandica, Cuprum Metallicum, Cysteinum, Glycyrrhiza Glabra, Hepar Suis, Lappa Major, Lycopodium Clavatum, Mercurius Solubilis, Nux Vomica, Plantago Major, Plumbum Metallicum, Pyridoxinum Hydrochloricum, Selenium Metallicum, Stillingia Sylvatica, Thyroidinum, Trifolium Pratense, Zingiber Officinale LIQUID ORAL 20140620 UNAPPROVED HOMEOPATHIC Energetix Corp ONION; GARLIC; .ALPHA.-LIPOIC ACID; ALUMINUM OXIDE; ARSENIC; BERBERIS VULGARIS ROOT BARK; CADMIUM; MILK THISTLE; CETRARIA ISLANDICA SUBSP. ISLANDICA; COPPER; CYSTEINE; GLYCYRRHIZA GLABRA; PORK LIVER; ARCTIUM LAPPA ROOT; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; LEAD; PYRIDOXINE HYDROCHLORIDE; SELENIUM; STILLINGIA SYLVATICA ROOT; THYROID, BOVINE; TRIFOLIUM PRATENSE FLOWER; GINGER 6; 6; 12; 15; 15; 4; 15; 4; 12; 15; 12; 4; 9; 4; 4; 15; 12; 4; 15; 12; 15; 4; 9; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0071_4cfbe1a5-de4d-4ec8-af20-1a201409924a 64578-0071 HUMAN OTC DRUG MycoCan-Chord Alumina, Avena Sativa, Borax, Candida Albicans, Carbolicum Acidum, Ceanothus Americanus, Echinacea (Angustifolia), Gaultheria Procumbens, Glandula Suprarenalis Suis, Hydrastis Canadensis, Linum Usitatissimum, Lithium Carbonicum, Medulla Ossis Suis, Natrum Muriaticum, Phosphoricum Acidum, Phytolacca Decandra, Sarcolacticum Acidum, Sepia, Silicea, Solidago Virgaurea, Tellurium Metallicum, Teucrium Marum, Zincum Metallicum LIQUID ORAL 20140818 UNAPPROVED HOMEOPATHIC Energetix Corp ALUMINUM OXIDE; AVENA SATIVA FLOWERING TOP; SODIUM BORATE; CANDIDA ALBICANS; PHENOL; CEANOTHUS AMERICANUS LEAF; ECHINACEA ANGUSTIFOLIA; GAULTHERIA PROCUMBENS TOP; SUS SCROFA ADRENAL GLAND; GOLDENSEAL; FLAX SEED; LITHIUM CARBONATE; SUS SCROFA BONE MARROW; SODIUM CHLORIDE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; LACTIC ACID, L-; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; TELLURIUM; TEUCRIUM MARUM; ZINC 15; 4; 8; 16; 8; 4; 4; 6; 9; 4; 6; 12; 9; 12; 12; 12; 12; 15; 12; 4; 15; 6; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0072_aea4afe4-8183-4ba7-9b6c-027b1cd97aee 64578-0072 HUMAN OTC DRUG Neuro-Chord Homeopathic Liquid LIQUID ORAL 20171103 UNAPPROVED HOMEOPATHIC Energetix Corporation AMANITA MUSCARIA FRUITING BODY; ALUMINUM; ARSENIC; CADMIUM; COENZYME A; CONIUM MACULATUM FLOWERING TOP; COPPER; GELSEMIUM SEMPERVIRENS ROOT; SUS SCROFA ADRENAL GLAND; LATRODECTUS MACTANS; NAJA NAJA VENOM; PHOSPHORUS; LEAD; PYRIDOXINE HYDROCHLORIDE; TOXICODENDRON PUBESCENS LEAF; RIBOFLAVIN; SARSAPARILLA; CITHARACANTHUS SPINICRUS; THIAMINE HYDROCHLORIDE; ZINC 12; 15; 15; 15; 12; 12; 15; 30; 9; 30; 30; 12; 15; 12; 12; 12; 6; 30; 12; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0073_7888f63e-3c2e-4414-8dd5-e26748bf56e6 64578-0073 HUMAN OTC DRUG Para-Chord Homeopathic Liquid LIQUID ORAL 20150707 UNAPPROVED HOMEOPATHIC Energetix Corp ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA VULGARIS ROOT; PEUMUS BOLDUS LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; DRYOPTERIS FILIX-MAS ROOT; PUNICA GRANATUM ROOT BARK; GRAPHITE; SODIUM PHOSPHATE, DIBASIC; SILICON DIOXIDE; WHITE MUSTARD SEED; SPIGELIA ANTHELMIA; TANACETUM VULGARE TOP; TEUCRIUM MARUM 12; 12; 4; 15; 12; 5; 4; 12; 12; 12; 12; 12; 6; 12; 5 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0074_4eb7b1f5-fe2d-439b-bc2f-353c72f77c92 64578-0074 HUMAN OTC DRUG Tox-Chord Homeopathic Liquid LIQUID ORAL 20141021 UNAPPROVED HOMEOPATHIC Energetix Corp ALFALFA; ALUMINUM OXIDE; BENZOIC ACID; D&C BLACK NO. 2; CETRARIA ISLANDICA SUBSP. ISLANDICA; ESTRONE; FUCUS VESICULOSUS; FUMARIC ACID; PORK LIVER; POTASSIUM CARBONATE; WOOD CREOSOTE; SODIUM CHLORIDE; PARAFFIN; KEROSENE; PHOSPHORIC ACID; PHOSPHORUS; PINE TAR; PLANTAGO MAJOR; LEAD; PULSATILLA VULGARIS; RADIUM BROMIDE; RESORCINOL; PHENYL SALICYLATE; SILICON DIOXIDE; COMFREY ROOT; TOBACCO LEAF; TURPENTINE OIL; THYROID, UNSPECIFIED; ELYMUS REPENS ROOT; ZINC OXIDE 4; 18; 18; 18; 9; 18; 5; 18; 9; 12; 18; 12; 18; 18; 12; 12; 18; 4; 15; 12; 15; 18; 18; 12; 4; 30; 18; 9; 4; 18 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL E 20171231 64578-0075_165d1816-5b17-4858-9e9a-abb4058a657e 64578-0075 HUMAN OTC DRUG Rena-Chord Homeopathic Liquid LIQUID ORAL 20160428 UNAPPROVED HOMEOPATHIC Energetix Corp ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC; AGATHOSMA BETULINA LEAF; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CADMIUM; LYTTA VESICATORIA; COBALT; COPPER; ECHINACEA ANGUSTIFOLIA; EUTROCHIUM PURPUREUM ROOT; IRON; LITHIUM CARBONATE; MERCURIC CHLORIDE; KEROSENE; PLATINUM; LEAD; PULSATILLA VULGARIS; SAW PALMETTO; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; ANTIMONY; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TITANIUM; ELYMUS REPENS ROOT; ARCTOSTAPHYLOS UVA-URSI LEAF; VANADIUM; ZINC 15; 12; 15; 6; 4; 12; 15; 8; 15; 15; 4; 6; 15; 15; 15; 15; 15; 15; 12; 8; 5; 6; 15; 4; 12; 15; 4; 5; 15; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0076_403b3bc8-925d-4638-96f0-4524ab14eeb5 64578-0076 HUMAN OTC DRUG Thyro-Chord Homeopathic Liquid LIQUID ORAL 20170908 UNAPPROVED HOMEOPATHIC Energetix Corporation ACETIC ACID; .ALPHA.-KETOGLUTARIC ACID; AMMONIUM CHLORIDE; SILVER; ASPARAGUS; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CHELIDONIUM MAJUS; COENZYME A; COPPER; ECHINACEA ANGUSTIFOLIA; FERROUS IODIDE; FUCUS VESICULOSUS; FUMARIC ACID; GENTIANA LUTEA ROOT; GLYCYRRHIZA GLABRA; IODINE; POTASSIUM IODIDE; MERCURIUS SOLUBILIS; NADIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PALLADIUM; PHOSPHORIC ACID; PERSICARIA PUNCTATA; PULSATILLA VULGARIS; RANCID BEEF; SAGE; SILICON DIOXIDE; TIN; SUCCINIC ACID; THYROID, UNSPECIFIED; VANADIUM; ZINC OXIDE 15; 12; 15; 15; 12; 15; 12; 4; 12; 15; 4; 12; 6; 12; 4; 4; 8; 12; 15; 12; 12; 12; 15; 12; 12; 12; 12; 8; 12; 15; 12; 9; 15; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0077_c2a0d336-8cc1-434a-b71d-f6443f14df27 64578-0077 HUMAN OTC DRUG Vac-Chord Homeopathic Liquid LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC Energetix Corp ALUMINUM OXIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; PEUMUS BOLDUS LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MILK THISTLE; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; EGG PHOSPHOLIPIDS; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; MEASLES VIRUS; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; PHYTOLACCA AMERICANA ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED 15; 12; 4; 12; 4; 12; 4; 12; 4; 4; 4; 12; 16; 12; 15; 30; 30; 4; 30; 12; 12; 15; 4; 6; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL E 20171231 64578-0078_a66039c4-de46-4036-b189-05a79646639b 64578-0078 HUMAN OTC DRUG Viru-Chord Homeopathic Liquid LIQUID ORAL 20140606 UNAPPROVED HOMEOPATHIC Energetix Corp ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; SUS SCROFA ADRENAL GLAND; GLYCYRRHIZA GLABRA; PORK LIVER; GOLDENSEAL; STAR ANISE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACHESIS MUTA VENOM; ARCTIUM LAPPA ROOT; MAGNESIUM PHOSPHATE, DIBASIC; MEASLES VIRUS; MYRRH; RORIPPA NASTURTIUM-AQUATICUM; LARREA TRIDENTATA TOP; STRYCHNOS NUX-VOMICA SEED; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SAMBUCUS NIGRA FLOWERING TOP; SCUTELLARIA LATERIFLORA; THIAMINE HYDROCHLORIDE; THYROID, UNSPECIFIED 12; 12; 4; 6; 9; 4; 9; 4; 12; 30; 30; 12; 4; 12; 30; 4; 6; 12; 12; 12; 12; 4; 6; 12; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0079_4f85ab0f-363f-423f-8a12-639da230215a 64578-0079 HUMAN OTC DRUG Adrenal-Tone Homeopathic Liquid LIQUID ORAL 20140521 UNAPPROVED HOMEOPATHIC Energetix Corp EPINEPHRINE; AVENA SATIVA FLOWERING TOP; GINKGO; GLYCYRRHIZA GLABRA; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SARSAPARILLA; THYROID, UNSPECIFIED; VERATRUM ALBUM ROOT; ZINC 12; 4; 4; 4; 12; 12; 12; 12; 12; 4; 6; 12; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL E 20171231 64578-0080_c3dbaf59-8de6-486d-ad39-42f509691d65 64578-0080 HUMAN PRESCRIPTION DRUG Drainage-Tone Homeopathic Liquid LIQUID ORAL 20140109 UNAPPROVED HOMEOPATHIC Energetix Corp CALCIUM IODIDE; CAPSICUM; COENZYME A; ECHINACEA ANGUSTIFOLIA; EQUISETUM ARVENSE TOP; GOLDENSEAL; NADIDE; NITRIC ACID; COD LIVER OIL; PETROSELINUM CRISPUM; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE; WHITE MUSTARD SEED; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 8; 4; 6; 4; 8; 12; 15; 4; 4; 4; 12; 4; 4 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 64578-0081_c028ae81-a5bd-43aa-90fa-9c35e94a8793 64578-0081 HUMAN OTC DRUG Flu-Tone Anas Barbariae, Hepatis Et Cordis Extractum, Azadirachta Indica, Baptisia Tinctoria, Bryonia, Crotalus Horridus, Echinacea, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Ginkgo Biloba, Influenzinum, Mucosa Nasalis Suis, Phytolacca Decandra, Pinus Sylvestris, Pyrogenium, Selenium Metallicum, Stillingia Sylvatica LIQUID ORAL 20150705 20201117 UNAPPROVED HOMEOPATHIC Energetix Corp CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; AZADIRACHTA INDICA BARK; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; INFLUENZA A VIRUS; INFLUENZA B VIRUS; SUS SCROFA NASAL MUCOSA; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; RANCID BEEF; SELENIUM; STILLINGIA SYLVATICA ROOT 15; 12; 4; 12; 15; 4; 30; 12; 6; 4; 30; 30; 9; 4; 9; 30; 12; 4 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0082_8219def9-d532-4be9-9cdb-c2ddc2852bd7 64578-0082 HUMAN OTC DRUG GB-Tone Ammi Visnaga, Atropinum Sulphuricum, Boldo, Carduus Marianus, Chelidonium Majus, Echinacea, Fel Tauri, Hepar Suis, Hydrastis Canadensis, Leptandra Virginica, Magnesia Phosphorica, Natrum Phosphoricum, Podophyllum Peltatum, Taraxacum Officinale LIQUID ORAL 20140409 20210601 UNAPPROVED HOMEOPATHIC Energetix Corp AMMI VISNAGA FRUIT; ATROPINE SULFATE; PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; BOS TAURUS BILE; PORK LIVER; GOLDENSEAL; VERONICASTRUM VIRGINICUM ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PODOPHYLLUM; TARAXACUM OFFICINALE 12; 12; 4; 4; 12; 4; 8; 9; 4; 12; 12; 6; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0083_185d7213-cfc3-4fef-83ff-e356ff25ac2d 64578-0083 HUMAN OTC DRUG Inflamma-Tone Aconitum Napellus, Belladonna, Bryonia (Alba), Chamomilla LIQUID ORAL 20131003 UNAPPROVED HOMEOPATHIC Energetix Corp ACONITUM NAPELLUS; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0084_b13dd2d1-fad2-4652-81f1-fd1139aa94ba 64578-0084 HUMAN OTC DRUG Kidney-Tone Agrimonia Eupatoria, Berberis Vulgaris, Calcarea Oxalica, Calcarea Phosphorica, Cantharis, Echinacea, Equisetum Arvense, Ferrum Phosphoricum, Lycopodium Clavatum, Pareira Brava, Petroselinum Sativum, Rubia Tinctorum, Sarsaparilla, Solidago Virgaurea, Uva-Ursi LIQUID ORAL 20131205 UNAPPROVED HOMEOPATHIC Energetix Corp AGRIMONIA EUPATORIA WHOLE; BERBERIS VULGARIS ROOT BARK; CALCIUM OXALATE MONOHYDRATE; TRIBASIC CALCIUM PHOSPHATE; LYTTA VESICATORIA; ECHINACEA ANGUSTIFOLIA; EQUISETUM ARVENSE TOP; FERRUM PHOSPHORICUM; LYCOPODIUM CLAVATUM SPORE; CHONDRODENDRON TOMENTOSUM ROOT; PETROSELINUM CRISPUM; RUBIA TINCTORUM ROOT; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF 12; 4; 12; 12; 12; 4; 12; 12; 12; 4; 4; 12; 5; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0085_b7d783da-be0c-4d0e-b51c-33f6374ac304 64578-0085 HUMAN OTC DRUG Hepatic-Tone Carduus Marianus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Citricum Acidum, Cysteinum, Hepar Suis, Leptandra Virginica, Magnesia Muriatica, Natrum Sulphuricum, Nux Vomica, Phosphorus, Quassia (Amara), Taraxacum Officinale LIQUID ORAL 20140529 UNAPPROVED HOMEOPATHIC Energetix Corp MILK THISTLE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; ANHYDROUS CITRIC ACID; CYSTEINE; PORK LIVER; VERONICASTRUM VIRGINICUM ROOT; MAGNESIUM CHLORIDE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; QUASSIA AMARA WOOD; TARAXACUM OFFICINALE 4; 12; 4; 8; 8; 8; 9; 12; 8; 12; 12; 12; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0086_7f3e77c2-bfa3-4fc3-8849-0edc293b12e4 64578-0086 HUMAN OTC DRUG Lymph-Tone I Adenosinum Cyclophosphoricum, Apis Mellifica, Aranea Diadema, Belladonna, Boldo, Calcarea Carbonica, Echinacea (Angustifolia),Galium Aparine, Glandula Suprarenalis Suis, Hypothalamus (Bovine), Kali Iodatum, Phosphorus, Phytolacca Decandra, Pinus Sylvestris, Pituitarum Posterium (Bovine), Pulsatilla (Vulgaris), Rhus Tox, Scrophularia Nodosa, Sulphur, Thyroidinum (Bovine) LIQUID ORAL 20150702 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; APIS MELLIFERA; ARANEUS DIADEMATUS; ATROPA BELLADONNA; PEUMUS BOLDUS LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ECHINACEA ANGUSTIFOLIA; GALIUM APARINE; SUS SCROFA ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; POTASSIUM IODIDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; BOS TAURUS PITUITARY GLAND; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCROPHULARIA NODOSA; SULFUR; THYROID, PORCINE; THYROID, BOVINE 12; 12; 12; 12; 4; 12; 4; 12; 9; 12; 4; 12; 4; 9; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0087_b137b0df-a035-4817-8037-76877f190175 64578-0087 HUMAN PRESCRIPTION DRUG Lymph-Tone II Homeopathic Liquid LIQUID ORAL 20140409 UNAPPROVED HOMEOPATHIC Energetix Corp HORSE CHESTNUT; AZADIRACHTA INDICA BARK; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; PEUMUS BOLDUS LEAF; BUFO BUFO CUTANEOUS GLAND; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; COENZYME A; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; SUS SCROFA ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; WOOD CREOSOTE; NADIDE; SODIUM CHLORIDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SUS SCROFA PITUITARY GLAND; PINE TAR; PULSATILLA VULGARIS; SILICON DIOXIDE; STILLINGIA SYLVATICA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 12; 8; 12; 12; 4; 12; 12; 12; 12; 10; 6; 12; 9; 12; 15; 12; 12; 30; 4; 9; 6; 6; 12; 12; 4; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 64578-0088_64448bbf-949f-4963-97c0-ac3a95c808e3 64578-0088 HUMAN OTC DRUG Lymph-Tone III Homeopathic Liquid LIQUID ORAL 20140421 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; ARNICA MONTANA; PEUMUS BOLDUS LEAF; CALCIUM IODIDE; CALENDULA OFFICINALIS FLOWERING TOP; SUS SCROFA CARTILAGE; CEANOTHUS AMERICANUS LEAF; COENZYME A; HERRING SPERM DNA; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; BOS TAURUS HYPOTHALAMUS; NADIDE; NAJA NAJA VENOM; SODIUM SULFATE; KIDNEY BEAN; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SUS SCROFA PITUITARY GLAND; RANCID BEEF; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; VISCUM ALBUM FRUITING TOP 12; 12; 3; 12; 30; 6; 9; 12; 12; 4; 12; 12; 12; 12; 15; 30; 4; 15; 4; 9; 12; 12; 12; 15; 15; 9; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL E 20171231 64578-0089_964a6cbb-0e89-47d6-98c8-3dbebb001ce0 64578-0089 HUMAN PRESCRIPTION DRUG ReHydration Homeopathic Liquid LIQUID ORAL 20140113 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; ARABICA COFFEE BEAN; SUS SCROFA ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SARSAPARILLA; SILICON DIOXIDE; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED 12; 9; 9; 12; 6; 8; 4; 12; 4; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 64578-0090_8f74c592-87fa-42b0-968b-fd0260e4c9b0 64578-0090 HUMAN OTC DRUG ReHydration Adenosinum Cyclophosphoricum, Coffea Cruda, Glandula Suprarenalis Suis, Hypothalamus (Bovine), Kali Phosphoricum, Natrum Muriaticum, Sarsaparilla, Silicea, Taraxacum Officinale, Thyroidinum (Bovine) LIQUID ORAL 20141117 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; ARABICA COFFEE BEAN; SUS SCROFA ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SARSAPARILLA; SILICON DIOXIDE; TARAXACUM OFFICINALE; THYROID, BOVINE 12; 9; 9; 12; 6; 8; 4; 12; 4; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; 1/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0091_522080e6-9f19-4ccf-bac5-bc34aa6d6e3a 64578-0091 HUMAN OTC DRUG Relax-Tone Calcarea Carbonica, Coffea Cruda, Humulus Lupulus, Ignatia Amara, Kali Phosphoricum, Moschus, Nux Vomica, Passiflora Incarnate, Phosphorus, Pulsatilla Vulgaris, Staphysagria, Valeriana Officinalis LIQUID ORAL 20131001 UNAPPROVED HOMEOPATHIC Energetix Corp OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; HOPS; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; VALERIAN 12; 12; 10; 12; 12; 12; 12; 4; 12; 12; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0092_f8eedd6e-c247-4b33-8b64-ae183d7d3d01 64578-0092 HUMAN OTC DRUG Relief-Tone Arnica Montana, Belladonna, Cortisone Aceticum, Hypericum Perforatum, Symphytum Officinale LIQUID ORAL 20131204 UNAPPROVED HOMEOPATHIC Energetix Corp ARNICA MONTANA; ATROPA BELLADONNA; CORTISONE ACETATE; HYPERICUM PERFORATUM; COMFREY ROOT 12; 6; 24; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0093_9874926e-9407-4472-a7f2-49e7118af2c9 64578-0093 HUMAN PRESCRIPTION DRUG Sinus-Tone Homeopathic Liquid LIQUID ORAL 20140321 UNAPPROVED HOMEOPATHIC Energetix Corp ONION; MERCURIC SULFIDE; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; NUTMEG; PULSATILLA VULGARIS; SODIUM SULFATE; SUS SCROFA NASAL MUCOSA 12; 12; 4; 4; 12; 30; 6; 12; 12; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] E 20171231 64578-0094_36efcdcc-795f-4fd9-b3d4-424fd98a6fe9 64578-0094 HUMAN OTC DRUG Throat-Spray Tone Homeopathic Liquid LIQUID ORAL 20140908 UNAPPROVED HOMEOPATHIC Energetix Corp APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CLOVE; CALCIUM SULFIDE; GOLDENSEAL; LACHESIS MUTA VENOM; MENTHA PIPERITA; MERCURIUS SOLUBILIS; MYRRH; PHYTOLACCA AMERICANA ROOT; SAGE; ACMELLA OLERACEA FLOWERING TOP; THYMUS SERPYLLUM 12; 4; 12; 4; 1; 15; 2; 12; 1; 12; 2; 4; 1; 2; 2 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL E 20171231 64578-0095_34ffd739-6277-4c0f-b03c-7da86e72005d 64578-0095 HUMAN OTC DRUG Adaptopath Adenosinum Cyclophosphoricum, Alpha-Lipoicum Acidum, Argentum Metallicum, Avena Sativa, Capsicum Annuum, Citricum Acidum, Coenzyme A, Cuprum Metallicum, Ginkgo Biloba, Glandula Suprarenalis Suis, Glycyrrhiza Glabra, Hypothalamus (Bovine), Iodium, Ledum Palustre, Manganum Aceticum, Nadidum, Natrum Carbonicum, Oleum Morrhuae, Phosphoricum Acidum, Picricum Acidum, Riboflavinum, Selenium Metallicum Sepia, Silicea, Thiaminum Hydrochloricum, Thyroidinum (Bovine), Vanadium Metallicum LIQUID ORAL 20141022 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; .ALPHA.-LIPOIC ACID; SILVER; AVENA SATIVA FLOWERING TOP; CAPSICUM; ANHYDROUS CITRIC ACID; COENZYME A; COPPER; GINKGO; SUS SCROFA ADRENAL GLAND; GLYCYRRHIZA GLABRA; BOS TAURUS HYPOTHALAMUS; IODINE; LEDUM PALUSTRE TWIG; MANGANESE ACETATE TETRAHYDRATE; NADIDE; SODIUM CARBONATE; COD LIVER OIL; PHOSPHORIC ACID; PICRIC ACID; RIBOFLAVIN; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THIAMINE HYDROCHLORIDE; THYROID, BOVINE; VANADIUM 8; 12; 12; 4; 4; 4; 8; 12; 4; 9; 4; 12; 12; 6; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12; 8; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0096_8cc7a991-ca60-44cf-b70a-a8d1fce90acc 64578-0096 HUMAN OTC DRUG Adrenapath Carduus Marianus, Chelidonium Majus, Echinacea (Angustifolia), Glandula Suprarenalis Suis, Natrum Muriaticum, Phosphoricum Acidum, Pituitarum Posterium (Bovine), Thyroidinum (Bovine) LIQUID ORAL 20170313 UNAPPROVED HOMEOPATHIC Energetix Corporation MILK THISTLE; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; SUS SCROFA ADRENAL GLAND; SODIUM CHLORIDE; PHOSPHORIC ACID; BOS TAURUS PITUITARY GLAND; THYROID, BOVINE 12; 4; 4; 9; 12; 12; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0097_d613715f-9ceb-407d-899a-32f585dea42e 64578-0097 HUMAN PRESCRIPTION DRUG Circulopath Homeopathic Liquid LIQUID ORAL 20140613 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; ARNICA MONTANA; GOLD; BARIUM CHLORIDE DIHYDRATE; BORAGE; CHOLESTEROL; LEMON JUICE; COENZYME A; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; GINKGO; BOS TAURUS HYPOTHALAMUS; POTASSIUM IODIDE; PRUNUS LAUROCERASUS LEAF; MAGNESIUM CHLORIDE; MAGNOLIA GRANDIFLORA FLOWER; NADIDE; KIDNEY BEAN; PHOSPHORUS; THYROID, UNSPECIFIED 10; 30; 12; 12; 4; 12; 4; 10; 12; 6; 4; 12; 12; 10; 8; 4; 9; 5; 30; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 64578-0098_6e7e87b1-cab4-4298-b0ba-5e7728510fde 64578-0098 HUMAN OTC DRUG Endopath-F Homeopathic Liquid LIQUID ORAL 20141006 UNAPPROVED HOMEOPATHIC Energetix Corp SUS SCROFA ADRENAL GLAND; CHASTE TREE; BLACK COHOSH; FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; BOS TAURUS HYPOTHALAMUS; ANGELICA ARCHANGELICA ROOT; SUS SCROFA OVARY; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THYROID, UNSPECIFIED; ZANTHOXYLUM AMERICANUM BARK; SUS SCROFA PITUITARY GLAND 9; 4; 4; 4; 4; 12; 6; 9; 12; 12; 9; 4; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL E 20171231 64578-0099_d4b3c24c-fec3-43d6-9a03-b65837c0504d 64578-0099 HUMAN OTC DRUG Endopath-M Adenosinum Cyclophosphoricum, Agnus Castus, Asparagus Officinalis, Avena Sativa, Cadmium Metallicum, Damiana, Glandula Suprarenalis Suis, Juniperus Communis, Lycopodium Clavatum, Orchitinum (Bovine), Petroselinum Sativum, Pituitarum Posterium (Bovine), Pulsatilla (Vulgaris), Sabal Serrulata, Sarsaparilla (Smilax Regelii) LIQUID ORAL 20141008 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; CHASTE TREE; ASPARAGUS; AVENA SATIVA FLOWERING TOP; CADMIUM; TURNERA DIFFUSA LEAFY TWIG; SUS SCROFA ADRENAL GLAND; JUNIPER BERRY; LYCOPODIUM CLAVATUM SPORE; BOS TAURUS TESTICLE; PETROSELINUM CRISPUM; SUS SCROFA PITUITARY GLAND; PULSATILLA VULGARIS; SAW PALMETTO; SMILAX REGELII ROOT 10; 4; 6; 4; 15; 6; 9; 4; 4; 9; 4; 12; 6; 4; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0100_1fc5e32b-35c0-4586-83d9-5b4a61b38480 64578-0100 HUMAN OTC DRUG Hypothalmapath Homeopathic Liquid LIQUID ORAL 20140327 UNAPPROVED HOMEOPATHIC Energetix Corp GELSEMIUM SEMPERVIRENS ROOT; GINKGO; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; BOS TAURUS HYPOTHALAMUS; SANDALWOOD OIL; PETROSELINUM CRISPUM; SUS SCROFA PITUITARY GLAND; PYRIDOXINE HYDROCHLORIDE; SENNA LEAF; SILICON DIOXIDE 12; 6; 4; 4; 12; 12; 4; 12; 12; 8; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL E 20171231 64578-0101_a994074a-aa37-4d05-ab4b-1a013743cb33 64578-0101 HUMAN OTC DRUG Endocrinpath Alfalfa, Borago Officinalis, Calcarea Carbonica, Ceanothus Americanus, Citricum Acidum, Fucus Vesiculosus, Ginkgo Biloba, Glandula Suprarenalis Suis, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Hypothalamus (Bovine), Kali Phosphoricum, Pancreas Suis, Phytolacca Decandra, Pituitarum Posterium (Bovine), Sarsaparilla (Smilax Regelii), Silicea, Syzygium Jambolanum, Taraxacum Officinale, Thyroidinum (Bovine) LIQUID ORAL 20141120 UNAPPROVED HOMEOPATHIC Energetix Corp ALFALFA; BORAGE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CEANOTHUS AMERICANUS LEAF; ANHYDROUS CITRIC ACID; FUCUS VESICULOSUS; GINKGO; SUS SCROFA ADRENAL GLAND; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; BOS TAURUS HYPOTHALAMUS; POTASSIUM PHOSPHATE, DIBASIC; SUS SCROFA PANCREAS; PHYTOLACCA AMERICANA ROOT; BOS TAURUS PITUITARY GLAND; SMILAX REGELII ROOT; SILICON DIOXIDE; SYZYGIUM CUMINI SEED; TARAXACUM OFFICINALE; THYROID, BOVINE 15; 15; 15; 4; 15; 15; 15; 9; 15; 15; 12; 15; 9; 4; 12; 15; 12; 4; 15; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0102_2434bbe1-d9ce-4880-b333-b5807bba4f17 64578-0102 HUMAN OTC DRUG Metabopath Adenosinum Cyclophosphoricum, Adenosinum Triphosphoricum Dinatrum, Alpha-Ketoglutaricum Acidum, Berberis Vulgaris, Citricum Acidum, Coenzyme A, DNA, Fumaricum Acidum, Glycyrrhiza Glabra, Hepar Sulphuris Calcareum, Lappa Major, Magnesia Phosphorica, Manganum Aceticum, Nadidum, Natrum Muriaticum, Natrum Oxalaceticum, Natrum Pyruvicum, Nicotinamidum, Pulsatilla, Pyridoxinum Hydrochloricum, Rhamnus Purshiana, Riboflavinum, RNA, Silicea, Succinicum Acidum, Sulphur, Thiaminum Hydrochloricum, LIQUID ORAL 20140808 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; .ALPHA.-KETOGLUTARIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; BERBERIS VULGARIS ROOT BARK; ANHYDROUS CITRIC ACID; COENZYME A; HERRING SPERM DNA; FUMARIC ACID; GLYCYRRHIZA GLABRA; CALCIUM SULFIDE; ARCTIUM LAPPA ROOT; MAGNESIUM PHOSPHATE, DIBASIC; MANGANESE ACETATE TETRAHYDRATE; NADIDE; SODIUM CHLORIDE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; NIACINAMIDE; PULSATILLA VULGARIS; PYRIDOXINE HYDROCHLORIDE; FRANGULA PURSHIANA BARK; RIBOFLAVIN; SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE; SUCCINIC ACID; SULFUR; THIAMINE HYDROCHLORIDE; THYROID, BOVINE; TRIFOLIUM PRATENSE FLOWER; ZANTHOXYLUM AMERICANUM BARK; ZINC GLUCONATE 8; 12; 12; 4; 8; 12; 30; 12; 4; 30; 4; 12; 10; 12; 12; 12; 12; 6; 12; 6; 4; 10; 30; 12; 12; 12; 6; 9; 4; 4; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0103_89ce6918-3dee-43e5-ba5e-13a4c9431be3 64578-0103 HUMAN OTC DRUG Renapath Benzoicum Acidum, Berberis Vulgaris, Bryonia, DNA, Eupatorium Purpureum, Glandula Suprarenalis Suis, Hydrangea Arborescens, Hypothalamus, Mercurius Corrosivus, Pancreas Suis, Pareira Brava, Petroselinum Sativum, Pituitarum Posterium, Rubia Tinctorum, Sarsaparilla, Solidago Virgaurea, Thyroidinum (Bovine), Uva-Ursi LIQUID ORAL 20140606 UNAPPROVED HOMEOPATHIC Energetix Corp BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; HERRING SPERM DNA; EUTROCHIUM PURPUREUM ROOT; SUS SCROFA ADRENAL GLAND; HYDRANGEA ARBORESCENS ROOT; BOS TAURUS HYPOTHALAMUS; MERCURIC CHLORIDE; SUS SCROFA PANCREAS; CHONDRODENDRON TOMENTOSUM ROOT; PETROSELINUM CRISPUM; SUS SCROFA PITUITARY GLAND; RUBIA TINCTORUM ROOT; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; THYROID, BOVINE; ARCTOSTAPHYLOS UVA-URSI LEAF 10; 4; 12; 12; 12; 9; 4; 12; 12; 9; 10; 4; 12; 6; 4; 4; 9; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0104_9ba485d9-1b99-4bd7-9604-9f5b96ab0673 64578-0104 HUMAN OTC DRUG Thyropath Homeopathic Liquid LIQUID ORAL 20140725 UNAPPROVED HOMEOPATHIC Energetix Corp AVENA SATIVA FLOWERING TOP; BORAGE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CHELIDONIUM MAJUS; FERROUS IODIDE; FUCUS VESICULOSUS; SUS SCROFA ADRENAL GLAND; PORK LIVER; IODINE; POTASSIUM IODIDE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; PYRIDOXINE HYDROCHLORIDE; THYROID, UNSPECIFIED; ZINC 4; 4; 12; 4; 12; 4; 9; 9; 12; 12; 12; 12; 10; 9; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL E 20171231 64578-0105_6e0a4714-0c2b-484b-9121-cd56b2a9e57f 64578-0105 HUMAN OTC DRUG Fields of Flowers Homeopathic Liquid LIQUID ORAL 20170901 UNAPPROVED HOMEOPATHIC Energetix Corporation AESCULUS CARNEA FLOWER; AESCULUS HIPPOCASTANUM FLOWER; HORSE CHESTNUT; AGRIMONIA EUPATORIA FLOWER; BROMUS RAMOSUS FLOWER; CALLUNA VULGARIS FLOWERING TOP; CARPINUS BETULUS FLOWERING TOP; CASTANEA SATIVA FLOWER; CENTAURIUM ERYTHRAEA FLOWER; CERATOSTIGMA WILLMOTTIANUM FLOWER; CICHORIUM INTYBUS FLOWER; CLEMATIS VITALBA FLOWER; FAGUS SYLVATICA FLOWERING TOP; GENTIANELLA AMARELLA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; HOTTONIA PALUSTRIS FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; JUGLANS REGIA FLOWERING TOP; LARIX DECIDUA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER; MIMULUS GUTTATUS FLOWERING TOP; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PINUS SYLVESTRIS FLOWERING TOP; POPULUS TREMULA FLOWERING TOP; PRUNUS CERASIFERA FLOWER; QUERCUS ROBUR FLOWER; ROSA CANINA FLOWER; SALIX ALBA FLOWERING TOP; SCLERANTHUS ANNUUS FLOWERING TOP; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; ULEX EUROPAEUS FLOWER; ULMUS PROCERA FLOWERING TWIG; VERBENA OFFICINALIS FLOWERING TOP; VITIS VINIFERA FLOWERING TOP 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL; [hp_C]/59.1mL N 20181231 64578-0106_ab6cfb46-2700-496b-a6e3-a71d04bedb12 64578-0106 HUMAN OTC DRUG Fields of Flowers Homeopathic Liquid LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC Energetix Corp AESCULUS CARNEA FLOWER; AESCULUS HIPPOCASTANUM FLOWER; HORSE CHESTNUT; AGRIMONIA EUPATORIA FLOWER; BROMUS RAMOSUS FLOWER; CALLUNA VULGARIS FLOWERING TOP; CARPINUS BETULUS FLOWERING TOP; CASTANEA SATIVA FLOWER; CENTAURIUM ERYTHRAEA FLOWER; CERATOSTIGMA WILLMOTTIANUM FLOWER; CICHORIUM INTYBUS FLOWER; FAGUS SYLVATICA FLOWERING TOP; GENTIANELLA AMARELLA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; HOTTONIA PALUSTRIS FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; JUGLANS REGIA FLOWERING TOP; LARIX DECIDUA FLOWERING TOP; LONICERA CAPRIFOLIUM FLOWERING TOP; MALUS DOMESTICA FLOWER; MIMULUS GUTTATUS FLOWERING TOP; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PINUS SYLVESTRIS FLOWERING TOP; PRUNUS CERASIFERA FLOWER; QUERCUS ROBUR FLOWER; ROSA CANINA FLOWER; SALIX ALBA FLOWERING TOP; SCLERANTHUS ANNUUS FLOWERING TOP; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; ULEX EUROPAEUS FLOWER; VERBENA OFFICINALIS FLOWERING TOP; VITIS VINIFERA FLOWERING TOP 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL E 20171231 64578-0107_f4116062-43e3-4ff4-83ec-9beed13cf34b 64578-0107 HUMAN OTC DRUG Rescue Calm Clematis Vitalba, Flos, Helianthemum Nummularium, Flos, Impatiens Glandulifera, Flos, Ornithogalum Umbellatum, Flos, Prunus Cerasifera, Flos LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC Energetix Corp CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 64578-0108_e52a3be8-2c55-42b6-89af-29df72716f9a 64578-0108 HUMAN OTC DRUG Rescue Calm Homeopathic Liquid LIQUID ORAL 20140825 UNAPPROVED HOMEOPATHIC Energetix Corp CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 30; 30; 30; 30; 30 [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL; [hp_C]/118.2mL E 20171231 64578-0109_921719d8-50c4-4f7f-af4c-2c2b3d45b2ab 64578-0109 HUMAN OTC DRUG Isopathic Phenolic Rings Homeopathic Liquid LIQUID ORAL 20171103 UNAPPROVED HOMEOPATHIC Energetix Corporation ACETALDEHYDE; ONION; BENZENE; COCOA; CAFFEINE; CANDIDA ALBICANS; PHENOL; CHOLINE; CINNAMON; ANHYDROUS CITRIC ACID; ARABICA COFFEE BEAN; COUMARIN; ESTRONE; GALLIC ACID; SUS SCROFA ADRENAL GLAND; HISTAMINE; BOS TAURUS HYPOTHALAMUS; INDOLE; BOS TAURUS TESTICLE; KEROSENE; PETROSELINUM CRISPUM; PHLORIZIN; PHOSPHORUS; GREEN PEPPERCORN; SUCROSE; TURPENTINE OIL; VALERIAN 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 9; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0110_a487316e-6d7d-46d3-bacc-7ff6761d4ab9 64578-0110 HUMAN OTC DRUG PhytoGel Homeopathic Gel GEL TOPICAL 20140314 UNAPPROVED HOMEOPATHIC Energetix Corp ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SULFURIC ACID; COMFREY ROOT 1; 12; 30; 1; 30; 1; 12; 30; 30; 12; 3 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL E 20171231 64578-0112_5072c593-6c52-4f5f-807a-cfb360fd9ee9 64578-0112 HUMAN OTC DRUG Lymph Tone II Aesculus hippocastanum, Azadirachta indica, Baryta carbonica, Berberis vulgaris, Boldo, Bufo rana, Calcarea carbonica, Calcarea phosphorica, Coenzyme A, Collinsonia canadensis, Echinacea (Angustifolia), Ferrum phosphoricum, Glandula suprarenalis suis, Hypothalamus, Kreosotum, Nadidum, Natrum muriaticum, Phosphorus, Phytolacca decandra, Pinus sylvestris, Pituitarum posterium (Bovine), Pix liquida, Pulsatilla (Vulgaris), Silicea, Stillingia sylvatica, Thuja occidentalis LIQUID ORAL 20140418 UNAPPROVED HOMEOPATHIC Energetix Corp HORSE CHESTNUT; AZADIRACHTA INDICA BARK; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; PEUMUS BOLDUS LEAF; BUFO BUFO CUTANEOUS GLAND; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; COENZYME A; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; SUS SCROFA ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; WOOD CREOSOTE; NADIDE; SODIUM CHLORIDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; BOS TAURUS PITUITARY GLAND; PINE TAR; PULSATILLA VULGARIS; SILICON DIOXIDE; STILLINGIA SYLVATICA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 12; 8; 12; 12; 4; 12; 12; 12; 12; 10; 6; 12; 9; 12; 15; 12; 12; 30; 4; 9; 12; 6; 12; 12; 4; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0113_399de03d-6f1b-48a6-8c4f-8ab0002a58ad 64578-0113 HUMAN OTC DRUG CV-Tone Ammi Visnaga, Cactus Grandiflorus, Convallaria Majalis, Gambogia, Tilia Europaea LIQUID ORAL 20140613 UNAPPROVED HOMEOPATHIC Energetix Corp AMMI VISNAGA FRUIT; SELENICEREUS GRANDIFLORUS STEM; CONVALLARIA MAJALIS; GAMBOGE; TILIA X EUROPAEA FLOWER 8; 12; 4; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0114_faf6882b-4c0e-419e-a2a8-d885e8feaa4a 64578-0114 HUMAN OTC DRUG Drainage-Tone Homeopathic Liquid LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Energetix Corp CALCIUM IODIDE; CAPSICUM; COENZYME A; ECHINACEA ANGUSTIFOLIA; EQUISETUM ARVENSE TOP; GOLDENSEAL; NADIDE; NITRIC ACID; COD LIVER OIL; PETROSELINUM CRISPUM; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE; WHITE MUSTARD SEED; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 8; 4; 6; 4; 8; 12; 15; 4; 4; 4; 12; 4; 4 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL E 20171231 64578-0115_d36f87be-fda9-4125-9337-130fb7a04b64 64578-0115 HUMAN OTC DRUG Endopath-F Homeopathic Liquid LIQUID ORAL 20150910 UNAPPROVED HOMEOPATHIC Energetix Corp CHASTE TREE; BLACK COHOSH; FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; BOS TAURUS HYPOTHALAMUS; ANGELICA SINENSIS ROOT; SUS SCROFA OVARY; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THYROID, UNSPECIFIED; ZANTHOXYLUM AMERICANUM BARK; SUS SCROFA PITUITARY GLAND; SUS SCROFA ADRENAL GLAND 4; 4; 4; 4; 12; 8; 9; 12; 12; 9; 4; 12; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0116_36acd131-f2f9-4412-ae1d-d933d4c2e02e 64578-0116 HUMAN OTC DRUG Rehydration Adenosinum Cyclophosphoricum, Coffea Cruda, Glandula Suprarenalis Suis, Hypothalamus (Bovine), Kali Phosphoricum, Natrum Muriaticum, Sarsaparilla (Smilax Regelii), Silicea, Taraxacum Officinale, Thyroidinum (Bovine) LIQUID ORAL 20151015 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; ARABICA COFFEE BEAN; SUS SCROFA ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SMILAX REGELII ROOT; SILICON DIOXIDE; TARAXACUM OFFICINALE; THYROID, BOVINE 12; 9; 9; 12; 6; 8; 4; 12; 4; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0117_68f1fad0-3173-47b7-9b2e-f980c3f0d2a9 64578-0117 HUMAN OTC DRUG Sinus-Tone Allium Cepa, Echinacea (Angustifolia), Hydrastis Canadensis, Kali Bichromicum, Mercurius Solubilis, Mercurius Sulphuratus Ruber, Mucosa Nasalis Suis, Natrum Sulphuricum, Nux Moschata, Pulsatilla (Vulgaris) LIQUID ORAL 20150728 20210615 UNAPPROVED HOMEOPATHIC Energetix Corp ONION; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; MERCURIC SULFIDE; SUS SCROFA NASAL MUCOSA; SODIUM SULFATE; NUTMEG; PULSATILLA VULGARIS 12; 4; 4; 12; 30; 12; 9; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0118_5cedd888-3898-471c-a437-e91e31d3ef0a 64578-0118 HUMAN OTC DRUG Circulopath Adenosinum cyclophosphoricum, Arnica montana, Aurum muriaticum, Baryta muriatica, Borago officinalis, Cholesterinum, Citrus limonum, Hypothalamus (Bovine), Kali iodatum, Laurocerasus, Magnesia muriatica, Nadidum, Phaseolus, Phosphorus, Thyroidinum (Bovine) LIQUID ORAL 20151204 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; ARNICA MONTANA; GOLD TRICHLORIDE; BARIUM CHLORIDE DIHYDRATE; BORAGE; CHOLESTEROL; LEMON JUICE; COENZYME A; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; GINKGO; BOS TAURUS HYPOTHALAMUS; POTASSIUM IODIDE; PRUNUS LAUROCERASUS LEAF; MAGNESIUM CHLORIDE; NADIDE; KIDNEY BEAN; PHOSPHORUS; THYROID, BOVINE 10; 30; 12; 12; 4; 12; 4; 10; 12; 6; 4; 12; 12; 10; 8; 9; 5; 30; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0120_69e24434-0cdc-4217-affe-a906c12c5f05 64578-0120 HUMAN OTC DRUG Viru-Chord Belladonna, Cinchona Officinalis, Echinacea (Angustifolia), Gelsemium Sempervirens, Glandula Suprarenalis Suis, Glycyrrhiza Glabra, Hepar Suis, Hydrastis Canadensis, Illicium Anisatum, Influenzinum, Lachesis Mutus, Lappa Major, Magnesia Phosphorica, Morbillinum, Myrrha, Nasturtium Aquaticum, Nux Vomica, Paloondo, Pyridoxinum Hydrochloricum, Riboflavinum, Sambucus Nigra, Scutellaria Lateriflora, Thiaminum Hydrochloricum, Thyroidinum (Bovine) LIQUID ORAL 20150811 20210114 UNAPPROVED HOMEOPATHIC Energetix Corp ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; SUS SCROFA ADRENAL GLAND; GLYCYRRHIZA GLABRA; PORK LIVER; GOLDENSEAL; STAR ANISE; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LACHESIS MUTA VENOM; ARCTIUM LAPPA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MEASLES VIRUS; MYRRH; NASTURTIUM OFFICINALE; STRYCHNOS NUX-VOMICA SEED; LARREA TRIDENTATA LEAF; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SAMBUCUS NIGRA FLOWERING TOP; SCUTELLARIA LATERIFLORA; THIAMINE HYDROCHLORIDE; THYROID, BOVINE 12; 12; 4; 6; 9; 4; 9; 4; 12; 30; 30; 12; 4; 12; 30; 4; 6; 12; 12; 12; 12; 4; 6; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0121_cf34eed2-ec82-43cc-bdc5-593c6d52d1c7 64578-0121 HUMAN OTC DRUG Adrenal Tone Adrenalinum, Avena Sativa, Ginkgo Biloba, Glycyrrhiza Glabra, Kali Phosphoricum, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pituitarum Posterium (Bovine), Sarsaparilla (Smilax Regelii), Thyroidinum (Bovine), Veratrum Album, Zincum Metallicum LIQUID ORAL 20160407 UNAPPROVED HOMEOPATHIC Energetix Corp EPINEPHRINE; AVENA SATIVA FLOWERING TOP; GINKGO; GLYCYRRHIZA GLABRA; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; BOS TAURUS PITUITARY GLAND; SMILAX REGELII ROOT; THYROID, BOVINE; VERATRUM ALBUM ROOT; ZINC 12; 4; 4; 4; 12; 12; 12; 12; 12; 4; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0122_6f3ec2ef-bda8-4caf-814a-7ab0ef3fa0eb 64578-0122 HUMAN OTC DRUG Tox-Chord Alfalfa, Alumina, Benzoicum Acidum, Carboneum, Cetraria Islandica, Folliculinum, Fucus Vesiculosus, Fumaricum Acidum, Hepar Suis, Kali Carbonicum, Kreosotum, Natrum Muriaticum, Paraffinum, Petroleum, Phosphoricum Acidum, Phosphorus, Pix Liquida, Plantago Major, Plumbum Metallicum, Pulsatilla (Vulgaris), Radium Bromatum, Resorcinum, Salol, Silicea, Symphytum Officinale, Tabacum, Terebinthina, Thyroidinum (Bovine), Triticum Repens, Zincum Oxydatum LIQUID ORAL 20150923 20210727 UNAPPROVED HOMEOPATHIC Energetix Corp ALFALFA; ALUMINUM OXIDE; BENZOIC ACID; D&C BLACK NO. 2; CETRARIA ISLANDICA SUBSP. ISLANDICA; ESTRONE; FUCUS VESICULOSUS; FUMARIC ACID; PORK LIVER; POTASSIUM CARBONATE; WOOD CREOSOTE; SODIUM CHLORIDE; PARAFFIN; KEROSENE; PHOSPHORIC ACID; PHOSPHORUS; PINE TAR; PLANTAGO MAJOR; LEAD; PULSATILLA VULGARIS; RADIUM BROMIDE; RESORCINOL; PHENYL SALICYLATE; SILICON DIOXIDE; COMFREY ROOT; TOBACCO LEAF; TURPENTINE OIL; THYROID, BOVINE; ELYMUS REPENS ROOT; ZINC OXIDE 4; 18; 18; 18; 9; 18; 5; 18; 9; 12; 18; 12; 18; 18; 12; 12; 18; 4; 15; 12; 15; 18; 18; 12; 4; 30; 18; 9; 4; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0123_cebfe4c6-a79b-433d-aa9f-328053f8f09e 64578-0123 HUMAN OTC DRUG Thyropath Avena Sativa, Borago Officinalis, Calcarea Carbonica, Chelidonium Majus, Ferrum Iodatum, Fucus Vesiculosus, Glandula Suprarenalis Suis, Hepar Suis, Iodium, Kali Iodatum, Phosphoricum Acidum, Pituitarum Posterium (Bovine), Pyridoxinum Hydrochloricum, Thyroidinum (Bovine), Zincum Metallicum LIQUID ORAL 20150923 20211007 UNAPPROVED HOMEOPATHIC Energetix Corp AVENA SATIVA FLOWERING TOP; BORAGE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CHELIDONIUM MAJUS; FERROUS IODIDE; FUCUS VESICULOSUS; SUS SCROFA ADRENAL GLAND; PORK LIVER; IODINE; POTASSIUM IODIDE; PHOSPHORIC ACID; BOS TAURUS PITUITARY GLAND; PYRIDOXINE HYDROCHLORIDE; THYROID, BOVINE; ZINC 4; 4; 12; 4; 12; 4; 9; 9; 12; 12; 12; 12; 10; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0124_6ed23898-70fa-49c2-8eab-d24079cd8377 64578-0124 HUMAN PRESCRIPTION DRUG Hypothalmapath Gelsemium Sempervirens, Ginkgo Biloba, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Hypothalamus (Bovine), Petroselinum Sativum, Pituitarum Posterium (Bovine), Pyridoxinum Hydrochloricum, Senna (Cassia Angustifolia), Silicea LIQUID ORAL 20160902 UNAPPROVED HOMEOPATHIC Energetix Corp GELSEMIUM SEMPERVIRENS ROOT; GINKGO; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; BOS TAURUS HYPOTHALAMUS; PETROSELINUM CRISPUM; BOS TAURUS PITUITARY GLAND, POSTERIOR; PYRIDOXINE HYDROCHLORIDE; SENNA LEAF; SILICON DIOXIDE 12; 6; 4; 4; 12; 4; 12; 12; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 64578-0125_44af0695-5390-439c-b50a-f720b8305bf9 64578-0125 HUMAN OTC DRUG Viru-Chord Belladonna, Cinchona Officinalis, Echinacea (Angustifolia), Gelsemium Sempervirens, Glandula Suprarenalis Suis, Glycyrrhiza Glabra, Hepar Suis, Hydrastis Canadensis, Illicium Anisatum, Influenzinum, Lachesis Mutus, Lappa Major, Magnesia Phosphorica, Morbillinum, Myrrha, Nasturtium Aquaticum, Nux Vomica, Paloondo, Pyridoxinum Hydrochloricum, Riboflavinum, Sambucus Nigra, Scutellaria Lateriflora, Thiaminum Hydrochloricum, Thyroidinum (Bovine) LIQUID ORAL 20160215 20210308 UNAPPROVED HOMEOPATHIC Energetix Corp ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; SUS SCROFA ADRENAL GLAND; GLYCYRRHIZA GLABRA; PORK LIVER; GOLDENSEAL; STAR ANISE; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); LACHESIS MUTA VENOM; ARCTIUM LAPPA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MEASLES VIRUS; MYRRH; NASTURTIUM OFFICINALE; STRYCHNOS NUX-VOMICA SEED; LARREA TRIDENTATA LEAF; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SAMBUCUS NIGRA FLOWERING TOP; SCUTELLARIA LATERIFLORA; THIAMINE HYDROCHLORIDE; THYROID, BOVINE 12; 12; 4; 6; 9; 4; 9; 4; 12; 30; 30; 30; 30; 30; 30; 12; 4; 12; 30; 4; 6; 12; 12; 12; 12; 4; 6; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0126_740a88e8-ad21-407f-975a-90b7972f0810 64578-0126 HUMAN OTC DRUG Flu-Tone Anas Barbariae, Hepatis Et Cordis Extractum, Azadirachta Indica, Baptisia Tinctoria, Bryonia (Alba), Crotalus Horridus, Echinacea (Angustifolia), Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Ginkgo Biloba, Influenzinum (2015-2016), Mucosa Nasalis Suis, Phytolacca Decandra, Pinus Sylvestris, Pyrogenium, Selenium Metallicum, Stillingia Sylvatica LIQUID ORAL 20160301 20210613 UNAPPROVED HOMEOPATHIC Energetix Corp CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; AZADIRACHTA INDICA BARK; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); SUS SCROFA NASAL MUCOSA; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; RANCID BEEF; SELENIUM; STILLINGIA SYLVATICA ROOT 15; 12; 4; 12; 15; 4; 30; 12; 6; 4; 30; 30; 30; 30; 30; 30; 9; 4; 9; 30; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0127_b270b503-bd93-4a44-a4a9-2a60fba66be1 64578-0127 HUMAN OTC DRUG Phytogel Arnica Montana, Calendula Officinalis, Hypericum Perforatum, Bellis Perennis, Calcarea Fluorica, Ferrum Phosphoricum, Ledum Palustre, Natrum Sulphuricum, Rhus Tox, Sulphuricum Acidum, Symphytum Officinale GEL TOPICAL 20160615 UNAPPROVED HOMEOPATHIC Energetix Corp ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; BELLIS PERENNIS; CALCIUM FLUORIDE; FERRUM PHOSPHORICUM; LEDUM PALUSTRE TWIG; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SULFURIC ACID; COMFREY ROOT 1; 1; 1; 12; 30; 30; 12; 30; 30; 12; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_C]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 64578-0128_c349cbfc-4096-4696-b201-6d341eb7f769 64578-0128 HUMAN OTC DRUG Viru-Chord Belladonna, Cinchona Officinalis, Echinacea (Angustifolia), Gelsemium Sempervirens, Glandula Suprarenalis Suis, Glycyrrhiza Glabra, Hepar Suis, Hydrastis Canadensis, Illicium Anisatum, Influenzinum, Lachesis Mutus, Lappa Major, Magnesia Phosphorica, Morbillinum, Myrrha, Nasturtium Aquaticum, Nux Vomica, Paloondo, Pyridoxinum Hydrochloricum, Riboflavinum, Sambucus Nigra, Scutellaria Lateriflora, Thiaminum Hydrochloricum, Thyroidinum (Bovine) LIQUID ORAL 20160601 UNAPPROVED HOMEOPATHIC Energetix Corp ATROPA BELLADONNA; CINCHONA OFFICINALIS BARK; ECHINACEA ANGUSTIFOLIA; GELSEMIUM SEMPERVIRENS ROOT; SUS SCROFA ADRENAL GLAND; GLYCYRRHIZA GLABRA; PORK LIVER; GOLDENSEAL; STAR ANISE; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); LACHESIS MUTA VENOM; ARCTIUM LAPPA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MEASLES VIRUS; MYRRH; NASTURTIUM OFFICINALE; STRYCHNOS NUX-VOMICA SEED; LARREA TRIDENTATA LEAF; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SAMBUCUS NIGRA FLOWERING TOP; SCUTELLARIA LATERIFLORA; THIAMINE HYDROCHLORIDE; THYROID, BOVINE 12; 12; 4; 6; 9; 4; 9; 5; 12; 30; 30; 30; 30; 30; 30; 12; 4; 12; 30; 4; 6; 12; 12; 12; 12; 4; 6; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0129_280b6d4a-f810-4213-889b-2b04be82f1d9 64578-0129 HUMAN OTC DRUG Sinus Tone Allium Cepa, Echinacea (Angustifolia), Hydrastis Canadensis, Kali Bichromicum, Mercurius Solubilis, Mercurius Sulphuratus Ruber, Mucosa Nasalis Suis, Natrum Sulphuricum, Nux Moschata, Pulsatilla (Vulgaris) LIQUID ORAL 20160609 UNAPPROVED HOMEOPATHIC Energetix Corp ONION; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; MERCURIC SULFIDE; SUS SCROFA NASAL MUCOSA; SODIUM SULFATE; NUTMEG; PULSATILLA VULGARIS 12; 4; 5; 12; 30; 12; 9; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0130_1189890d-a563-4d44-8932-907dcb07079f 64578-0130 HUMAN OTC DRUG GB-Tone Ammi Visnaga, Atropinum Sulphuricum, Boldo, Carduus Marianus, Chelidonium Majus, Echinacea, Fel Tauri, Hepar Suis, Hydrastis Canadensis, Leptandra Virginica, Magnesia Phosphorica, Natrum Phosphoricum, Podophyllum Peltatum, Taraxacum Officinale LIQUID ORAL 20160714 UNAPPROVED HOMEOPATHIC Energetix Corp AMMI VISNAGA FRUIT; ATROPINE SULFATE; PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; BOS TAURUS BILE; PORK LIVER; GOLDENSEAL; VERONICASTRUM VIRGINICUM ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PODOPHYLLUM; TARAXACUM OFFICINALE 12; 12; 4; 4; 12; 4; 8; 9; 5; 12; 12; 6; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0131_42f2abe3-d58f-4526-a41f-8485515dcbf1 64578-0131 HUMAN OTC DRUG Bacteria Chord Azadirachta Indica, Belladonna, Berberis Vulgaris, Boldo, Candida Albicans, Ceanothus Americanus, Cetraria Islandica, Crotalus Horridus, Echinacea (Angustifolia), Glandula Suprarenalis Suis, Glycyrrhiza Glabra, Hamamelis Virginiana, Hepar Suis, Hydrastis Canadensis, Hydrocotyle Asiatica, Hypericum Perforatum, Lappa Major, Ledum Palustre, Millefolium, Morbillinum, Myrrha, Pancreas Suis, Pertussinum, Phosphorus, Plantago Major, Pyrogenium, Solidago Virgaurea, Zingiber Officinale LIQUID ORAL 20161111 UNAPPROVED HOMEOPATHIC Energetix Corp AZADIRACHTA INDICA BARK; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; PEUMUS BOLDUS LEAF; CANDIDA ALBICANS; CEANOTHUS AMERICANUS LEAF; CETRARIA ISLANDICA SUBSP. ISLANDICA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; SUS SCROFA ADRENAL GLAND; GLYCYRRHIZA GLABRA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PORK LIVER; GOLDENSEAL; CENTELLA ASIATICA; HYPERICUM PERFORATUM; ARCTIUM LAPPA ROOT; LEDUM PALUSTRE TWIG; ACHILLEA MILLEFOLIUM; MEASLES VIRUS; MYRRH; SUS SCROFA PANCREAS; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; PHOSPHORUS; PLANTAGO MAJOR; RANCID BEEF; SOLIDAGO VIRGAUREA FLOWERING TOP; GINGER 8; 8; 9; 4; 30; 4; 12; 12; 4; 9; 4; 6; 9; 5; 6; 12; 4; 9; 12; 30; 4; 9; 30; 12; 4; 30; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0132_2ad25885-0d81-414b-8f73-dc19ec339d94 64578-0132 HUMAN OTC DRUG Tox-Chord Alfalfa, Alumina, Benzoicum Acidum, Carboneum, Cetraria Islandica, Folliculinum, Fucus Vesiculosus, Fumaricum Acidum, Hepar Suis, Kali Carbonicum, Kreosotum, Natrum Muriaticum, Paraffinum, Petroleum, Phosphoricum Acidum, Phosphorus, Pix Liquida, Plantago Major, Plumbum Metallicum, Pulsatilla (Vulgaris), Radium Bromatum, Resorcinum, Salol, Silicea, Symphytum Officinale, Tabacum, Terebinthina, Thyroidinum (Bovine), Triticum Repens, Zincum Oxydatum LIQUID ORAL 20161111 UNAPPROVED HOMEOPATHIC Energetix Corp ALFALFA; ALUMINUM OXIDE; BENZOIC ACID; D&C BLACK NO. 2; CETRARIA ISLANDICA SUBSP. ISLANDICA; ESTRONE; FUCUS VESICULOSUS; FUMARIC ACID; PORK LIVER; POTASSIUM CARBONATE; WOOD CREOSOTE; SODIUM CHLORIDE; PARAFFIN; KEROSENE; PHOSPHORIC ACID; PHOSPHORUS; PINE TAR; PLANTAGO MAJOR; LEAD; PULSATILLA VULGARIS; RADIUM BROMIDE; RESORCINOL; PHENYL SALICYLATE; SILICON DIOXIDE; COMFREY ROOT; TOBACCO LEAF; TURPENTINE OIL; THYROID, BOVINE; ELYMUS REPENS ROOT; ZINC OXIDE 4; 18; 18; 18; 9; 18; 5; 18; 9; 12; 18; 12; 18; 18; 12; 12; 18; 4; 15; 12; 15; 18; 18; 12; 6; 30; 18; 9; 4; 18 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0133_5ece903b-44ca-44be-aea1-ff2565faaacb 64578-0133 HUMAN OTC DRUG Thyropath Avena Sativa, Borago Officinalis, Calcarea Carbonica, Chelidonium Majus, Ferrum Iodatum, Fucus Vesiculosus, Glandula Suprarenalis Suis, Hepar Suis, Iodium, Kali Iodatum, Phosphoricum Acidum, Pituitarum Posterium (Bovine), Pyridoxinum Hydrochloricum, Thyroidinum (Bovine), Zincum Metallicum LIQUID ORAL 20161115 UNAPPROVED HOMEOPATHIC Energetix Corp AVENA SATIVA FLOWERING TOP; BORAGE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CHELIDONIUM MAJUS; FERROUS IODIDE; FUCUS VESICULOSUS; SUS SCROFA ADRENAL GLAND; PORK LIVER; IODINE; POTASSIUM IODIDE; PHOSPHORIC ACID; BOS TAURUS PITUITARY GLAND, POSTERIOR; PYRIDOXINE HYDROCHLORIDE; THYROID, BOVINE; ZINC 4; 6; 12; 4; 12; 4; 9; 9; 12; 12; 12; 12; 10; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0134_0ca57748-3ebb-4083-82da-7a504f010c36 64578-0134 HUMAN OTC DRUG Flu-Tone Anas Barbariae, Hepatis Et Cordis Extractum, Azadirachta Indica, Baptisia Tinctoria, Bryonia, Crotalus Horridus, Echinacea, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Ginkgo Biloba, Influenzinum, Mucosa Nasalis Suis, Phytolacca Decandra, Pinus Sylvestris, Pyrogenium, Selenium Metallicum, Stillingia Sylvatica LIQUID ORAL 20160301 UNAPPROVED HOMEOPATHIC Energetix Corp CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; AZADIRACHTA INDICA BARK; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED); SUS SCROFA NASAL MUCOSA; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; RANCID BEEF; SELENIUM; STILLINGIA SYLVATICA ROOT 15; 12; 4; 12; 15; 4; 30; 12; 6; 4; 30; 30; 30; 9; 4; 9; 30; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0135_56bfe47b-3b68-4008-b788-9d3a28f479e5 64578-0135 HUMAN OTC DRUG Flu-Tone Anas Barbariae, Hepatis Et Cordis Extractum, Azadirachta Indica, Baptisia Tinctoria, Bryonia (Alba), Crotalus Horridus, Echinacea (Angustifolia), Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Ginkgo Biloba, Influenzinum, Mucosa Nasalis Suis, Phytolacca Decandra, Pinus Sylvestris, Pyrogenium, Selenium Metallicum, Stillingia Sylvatica LIQUID ORAL 20171103 UNAPPROVED HOMEOPATHIC Energetix Corp CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; AZADIRACHTA INDICA BARK; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; GINKGO; INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED); SUS SCROFA NASAL MUCOSA; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; RANCID BEEF; SELENIUM; STILLINGIA SYLVATICA ROOT 15; 12; 4; 12; 15; 4; 30; 12; 6; 4; 30; 30; 30; 9; 4; 9; 30; 12; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64578-0141_8e16731c-5a1b-479a-9bb3-dd02822c8e38 64578-0141 HUMAN OTC DRUG Throat Spray- Tone Apis mellifica, Baptisia tinctoria, Belladonna, Calendula officinalis, Hepar sulphuris calcareum, Hydrastis canadensis, Lachesis mutus, Mercurius solubilis, Myrrha, Phytolacca decandra, Spilanthes oleracea. LIQUID ORAL 20171103 UNAPPROVED HOMEOPATHIC Energetix Corporation APIS MELLIFERA; BAPTISIA TINCTORIA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CALCIUM SULFIDE; GOLDENSEAL; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; MYRRH; PHYTOLACCA AMERICANA ROOT; ACMELLA OLERACEA FLOWERING TOP 12; 4; 12; 4; 15; 5; 12; 12; 5; 4; 5 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0142_1bc298ee-1595-407a-b59c-163e0155ea05 64578-0142 HUMAN OTC DRUG Drainage-Tone Calcarea iodata, Capsicum annuum, Coenzyme A, Echinacea angustifolia, Equisetum arvense, Hydrastis canadensis, Nadidum, Nitricum acidum, Oleum morrhuae, Petroselinum sativum, Phytolacca decandra, Scrophularia nodosa, Silicea, Sinapis alba, Thuja occidentalis. LIQUID ORAL 20170731 UNAPPROVED HOMEOPATHIC Energetix Corporation CALCIUM IODIDE; CAPSICUM; COENZYME A; ECHINACEA ANGUSTIFOLIA; EQUISETUM ARVENSE TOP; GOLDENSEAL; NADIDE; NITRIC ACID; COD LIVER OIL; PETROSELINUM CRISPUM; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE; WHITE MUSTARD SEED; THUJA OCCIDENTALIS LEAFY TWIG 12; 6; 8; 4; 6; 5; 8; 12; 15; 4; 4; 4; 12; 4; 4 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0143_ef31e3df-25df-43dc-9fb7-e65c4150aa8a 64578-0143 HUMAN OTC DRUG Vac-Chord Alumina, Arsenicum album, Baptisia tinctoria, Belladonna, Boldo, Calcarea carbonica, Carduus marianus, Chamomilla, Chelidonium majus, Echinacea, Hydrastis canadensis, Lecithin, Ledum palustre, Lycopodium clavatum, Mercurius solubilis, Morbillinum, Pertussinum, Phytolacca decandra, Pyrogenium, Rhus tox, Silicea, Sulphur, Taraxacum officinale, Thuja occidentalis, Thyroidinum. LIQUID ORAL 20170922 UNAPPROVED HOMEOPATHIC Energetix Corporation ALUMINUM OXIDE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; PEUMUS BOLDUS LEAF; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MILK THISTLE; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; EGG PHOSPHOLIPIDS; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; MEASLES VIRUS; HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED; PHYTOLACCA AMERICANA ROOT; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED 15; 12; 4; 12; 4; 12; 4; 12; 4; 4; 5; 12; 16; 12; 15; 30; 30; 4; 30; 12; 12; 15; 4; 6; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0144_8d6a98d6-50cd-42e9-a77a-2c57f3811959 64578-0144 HUMAN OTC DRUG MycoCan-Chord Alumina, Avena Sativa, Borax, Candida Albicans, Carbolicum Acidum, Ceanothus Americanus, Echinacea, Gaultheria Procumbens, Glandula Suprarenalis Suis, Hydrastis Canadensis, Linum Usitatissimum, Lithium Carbonicum, Medulla Ossis Suis, Natrum Muriaticum, Phosphoricum Acidum, Phytolacca Decandra, Sarcolacticum Acidum, Sepia, Silicea, Solidago Virgaurea, Tellurium Metallicum, Teucrium Marum, Zincum Metallicum LIQUID ORAL 20160610 UNAPPROVED HOMEOPATHIC Energetix Corp ALUMINUM OXIDE; AVENA SATIVA FLOWERING TOP; SODIUM BORATE; CANDIDA ALBICANS; PHENOL; CEANOTHUS AMERICANUS LEAF; ECHINACEA ANGUSTIFOLIA; GAULTHERIA PROCUMBENS TOP; SUS SCROFA ADRENAL GLAND; GOLDENSEAL; FLAX SEED; LITHIUM CARBONATE; SUS SCROFA BONE MARROW; SODIUM CHLORIDE; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; LACTIC ACID, L-; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; TELLURIUM; TEUCRIUM MARUM; ZINC 15; 4; 8; 16; 8; 4; 4; 6; 9; 5; 6; 12; 9; 12; 12; 12; 12; 15; 12; 4; 15; 6; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0145_da6fe039-7152-47b2-80da-2f8a76554d18 64578-0145 HUMAN OTC DRUG Lipo-Chord Aceticum ac, Acetylsal ac, Adrenocorticotrophin, Alumina, Arsenicum alb, Borago, Ceanothus, Chelidonium maj, Chionanthus, Chloramphenicolum, Chlorpromazinum, Cholesterinum, Cortisone aceticum, Damiana, Folliculinum, Fumaricum ac, Kali iod, Lycopodium, Nat sulphuricum, Nux vom, Oleum morrhuae, Petroleum, Phenacetinum, Phosphoricum ac, Phosphorus, Plumb met, Saccharum off, Silicea, Taraxacum, Thyroidinum. LIQUID ORAL 20170818 UNAPPROVED HOMEOPATHIC Energetix Corporation ACETIC ACID; ASPIRIN; CORTICOTROPIN HUMAN; ALUMINUM OXIDE; ARSENIC TRIOXIDE; BORAGE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHLORAMPHENICOL; CHLORPROMAZINE; CHOLESTEROL; CORTISONE ACETATE; TURNERA DIFFUSA LEAFY TWIG; ESTRONE; FUMARIC ACID; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; COD LIVER OIL; KEROSENE; PHENACETIN; PHOSPHORIC ACID; PHOSPHORUS; LEAD; SUCROSE; SILICON DIOXIDE; TARAXACUM OFFICINALE; THYROID, UNSPECIFIED 18; 18; 18; 18; 30; 6; 6; 12; 6; 18; 18; 12; 18; 12; 18; 30; 30; 30; 30; 30; 12; 18; 18; 30; 30; 30; 30; 30; 4; 9 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0146_7a848e80-9b8c-444f-b2bd-473464f70e93 64578-0146 HUMAN OTC DRUG Circulopath Adenosinum cyclophosphoricum, Arnica montana, Aurum muriaticum, Baryta muriatica, Borago officinalis, Cholesterinum, Citrus limonum, Hypothalamus (Bovine), Kali iodatum, Laurocerasus, Magnesia muriatica, Nadidum, Phaseolus, Phosphorus, Thyroidinum (Bovine) LIQUID ORAL 20160620 UNAPPROVED HOMEOPATHIC Energetix Corp ADENOSINE CYCLIC PHOSPHATE; ARNICA MONTANA; GOLD TRICHLORIDE; BARIUM CHLORIDE DIHYDRATE; BORAGE; CHOLESTEROL; LEMON JUICE; COENZYME A; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; GINKGO; BOS TAURUS HYPOTHALAMUS; POTASSIUM IODIDE; PRUNUS LAUROCERASUS LEAF; MAGNESIUM CHLORIDE; NADIDE; KIDNEY BEAN; PHOSPHORUS; THYROID, BOVINE 10; 30; 12; 12; 6; 12; 4; 10; 12; 6; 4; 12; 12; 10; 8; 9; 5; 30; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0147_fe636384-7dd4-4d4f-851b-971f7bf74218 64578-0147 HUMAN OTC DRUG Lymph-Tone III Adenosinum cyclophosphoricum, Arnica, Boldo, Calc iod, Calendula, Cartilago suis, Ceanothus, Coenzyme A, DNA, Echinacea, Hamamelis, Hepar sulph calc, Hypothalamus, Nadidum, Naja, Nat sulphuricum, Phaseolus, Phos, Phytolacca, Pinus syl, Pituitarum posterium, Pyrogenium, Silicea, Sulphur, Thuja occ, Thyroidinum, Viscum. LIQUID ORAL 20170901 UNAPPROVED HOMEOPATHIC Energetix Corporation ADENOSINE CYCLIC PHOSPHATE; ARNICA MONTANA; PEUMUS BOLDUS LEAF; CALCIUM IODIDE; CALENDULA OFFICINALIS FLOWERING TOP; SUS SCROFA CARTILAGE; CEANOTHUS AMERICANUS LEAF; COENZYME A; HERRING SPERM DNA; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; BOS TAURUS HYPOTHALAMUS; NADIDE; NAJA NAJA VENOM; SODIUM SULFATE; KIDNEY BEAN; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; SUS SCROFA PITUITARY GLAND; RANCID BEEF; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; VISCUM ALBUM FRUITING TOP 12; 12; 4; 12; 30; 6; 9; 12; 12; 4; 12; 12; 12; 12; 15; 30; 4; 15; 4; 9; 12; 12; 12; 15; 15; 9; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0148_7122aa5c-30f3-4e8c-bf25-5e3be31bd8fa 64578-0148 HUMAN OTC DRUG Aller-Chord F Acetaldehyde, Aceticum ac, Arg nit, Caffeinum, Calc sulph, Citricum ac, Cortisone aceticum, Echinacea purp, Folliculinum, Fragaria, Fumaricum ac, Gallicum ac, Glandula suprarenalis suis, Hepar suis, Histaminum hydrochloricum, Hydrangea, Lac vac, Lecithin, Limulus, Lycopersicum, Lycopodium, Nat bicarb, Nat mur, Nux vom, Paraffinum, Phosphoricum ac, Saccharum off, Silicea, Tartaricum ac, Torula cerevisiae. LIQUID ORAL 20140808 UNAPPROVED HOMEOPATHIC Energetix Corp ACETALDEHYDE; SUS SCROFA ADRENAL GLAND; SILVER NITRATE; CORTISONE ACETATE; GALLIC ACID MONOHYDRATE; HISTAMINE DIHYDROCHLORIDE; ECHINACEA PURPUREA; HYDRANGEA ARBORESCENS ROOT; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ACETIC ACID; CAFFEINE; CALCIUM SULFATE ANHYDROUS; ANHYDROUS CITRIC ACID; FUMARIC ACID; COW MILK; EGG PHOSPHOLIPIDS; SODIUM BICARBONATE; SUCROSE; TARTARIC ACID; SACCHAROMYCES CEREVISIAE; SODIUM CHLORIDE; PARAFFIN; ESTRONE; PHOSPHORIC ACID; ALPINE STRAWBERRY; LIMULUS POLYPHEMUS; SOLANUM LYCOPERSICUM; SILICON DIOXIDE 12; 9; 10; 20; 12; 12; 6; 6; 9; 12; 12; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 12; 15; 15; 15; 15; 15; 15; 15 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0149_507ed292-b925-4f1b-b9cd-4b94f2e4e4df 64578-0149 HUMAN OTC DRUG Kidney-Tone Agrimonia eupatoria, Berberis vulgaris, Calcarea oxalica, Calcarea phosphorica, Cantharis, Echinacea, Equisetum arvense, Ferrum phosphoricum, Lycopodium clavatum, Pareira brava, Petroselinum sativum, Rubia tinctorum, Sarsaparilla, Solidago virgaurea, Uva-ursi. LIQUID ORAL 20170401 UNAPPROVED HOMEOPATHIC Energetix Corporation AGRIMONIA EUPATORIA; BERBERIS VULGARIS ROOT BARK; CALCIUM OXALATE MONOHYDRATE; TRIBASIC CALCIUM PHOSPHATE; LYTTA VESICATORIA; ECHINACEA, UNSPECIFIED; EQUISETUM ARVENSE TOP; FERROSOFERRIC PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; CHONDRODENDRON TOMENTOSUM ROOT; PETROSELINUM CRISPUM; RUBIA TINCTORUM ROOT; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF 12; 4; 12; 12; 12; 4; 12; 12; 12; 4; 4; 12; 5; 5; 5 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0150_8ce61369-fd3d-4d03-8798-ef783bd217db 64578-0150 HUMAN OTC DRUG Adrenal-Tone Adrenalinum, Avena, Ginkgo, Glycyrrhiza, Kali phos, Nat mur, Nux vomica, Phosphoricum ac, Pituitarum posterium, Sarsaparilla, Thyroidinum, Veratrum alb, Zinc met. LIQUID ORAL 20171103 UNAPPROVED HOMEOPATHIC Energetix Corporation EPINEPHRINE; AVENA SATIVA FLOWERING TOP; GINKGO; GLYCYRRHIZA GLABRA; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND, POSTERIOR; SARSAPARILLA; THYROID, UNSPECIFIED; VERATRUM ALBUM ROOT; ZINC 12; 4; 4; 4; 12; 12; 12; 12; 12; 4; 6; 12; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0151_51464251-2c96-40a5-9faa-9e779ee17570 64578-0151 HUMAN OTC DRUG Tox-Chord Alfalfa, Alumina, Benzoicum ac, Carboneum, Cetraria, Folliculinum, Fucus, Fumaricum ac, Hepar suis, Kali carb, Kreosotum, Nat mur, Paraffinum, Petroleum, Phosphoricum ac, Phos, Pix liquida, Plantago, Plumb met, Pulsatilla, Radium brom, Resorcinum, Salol, Silicea, Symphytum, Tabacum, Terebinthina, Thyroidinum, Triticum, Zinc oxyd. LIQUID ORAL 20170401 UNAPPROVED HOMEOPATHIC Energetix Corporation ALFALFA; ALUMINUM OXIDE; BENZOIC ACID; D&C BLACK NO. 2; CETRARIA ISLANDICA SUBSP. ISLANDICA; ESTRONE; FUCUS VESICULOSUS; FUMARIC ACID; PORK LIVER; POTASSIUM CARBONATE; WOOD CREOSOTE; SODIUM CHLORIDE; PARAFFIN; KEROSENE; PHOSPHORIC ACID; PHOSPHORUS; PINE TAR; PLANTAGO MAJOR; LEAD; PULSATILLA VULGARIS; RADIUM BROMIDE; RESORCINOL; PHENYL SALICYLATE; SILICON DIOXIDE; COMFREY ROOT; TOBACCO LEAF; TURPENTINE OIL; THYROID, UNSPECIFIED; ELYMUS REPENS ROOT; ZINC OXIDE 4; 18; 18; 18; 9; 18; 5; 18; 9; 12; 18; 12; 18; 18; 12; 12; 18; 4; 15; 12; 15; 18; 18; 12; 6; 30; 18; 9; 4; 18 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_C]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0152_91ef4ed4-27bb-49f0-884b-746202668dfa 64578-0152 HUMAN OTC DRUG Hypothalmapath Gelsemium, Ginkgo, Glycyrrhiza, Hydrocotyle, Hypothalamus, Petroselinum, Pituitarum posterium, Pyridoxinum hydrochloricum, Senna, Silicea. LIQUID ORAL 20171103 UNAPPROVED HOMEOPATHIC Energetix Corporation GELSEMIUM SEMPERVIRENS ROOT; GINKGO; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; BOS TAURUS HYPOTHALAMUS; PETROSELINUM CRISPUM; SUS SCROFA PITUITARY GLAND; PYRIDOXINE HYDROCHLORIDE; SENNA LEAF; SILICON DIOXIDE 12; 6; 4; 4; 12; 4; 12; 12; 8; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0153_3eb350d8-e80a-4c70-8d07-14ba88544f20 64578-0153 HUMAN OTC DRUG Lymph-Tone II Aesculus hipp, Azadirachta, Baryta carb, Berber vulg, Boldo, Bufo, Calc carb, Calc phos, Coenzyme A, Collinsonia, Echinacea, Ferrum phos, Glandula suprarenalis suis, Hypothalamus, Kreosotum, Nadidum, Nat mur, Phos, Phytolacca, Pinus syl, Pituitarum posterium, Pix liquida, Pulsatilla, Silicea, Stillingia, Thuja occ. LIQUID ORAL 20171103 UNAPPROVED HOMEOPATHIC Energetix Corporation HORSE CHESTNUT; AZADIRACHTA INDICA BARK; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; PEUMUS BOLDUS LEAF; BUFO BUFO CUTANEOUS GLAND; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; COENZYME A; COLLINSONIA CANADENSIS ROOT; ECHINACEA ANGUSTIFOLIA; FERRUM PHOSPHORICUM; SUS SCROFA ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; WOOD CREOSOTE; NADIDE; SODIUM CHLORIDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; BOS TAURUS PITUITARY GLAND; PINE TAR; PULSATILLA VULGARIS; SILICON DIOXIDE; STILLINGIA SYLVATICA ROOT; THUJA OCCIDENTALIS LEAFY TWIG 12; 8; 12; 12; 4; 12; 12; 12; 12; 10; 6; 12; 9; 12; 15; 12; 12; 30; 4; 9; 12; 6; 12; 12; 4; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64578-0154_a008c388-37a6-4449-a838-f1f999ade172 64578-0154 HUMAN OTC DRUG Sinus-Tone Allium cepa, Echinacea, Hydrastis canadensis, Kali bichromicum, Mercurius solubilis, Mercurius sulphuratus ruber, Mucosa nasalis suis, Natrum sulphuricum, Nux moschata, Pulsatilla. LIQUID ORAL 20171019 UNAPPROVED HOMEOPATHIC Energetix Corporation ONION; ECHINACEA, UNSPECIFIED; GOLDENSEAL; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; MERCURIC SULFIDE; SUS SCROFA NASAL MUCOSA; SODIUM SULFATE; NUTMEG; PULSATILLA VULGARIS 12; 4; 5; 12; 30; 12; 9; 12; 6; 12 [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL N 20181231 64581-072_0b83aec3-ea71-4ec2-a6c2-fb429d993dad 64581-072 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990501 UNAPPROVED MEDICAL GAS Milner Rushing Home Care OXYGEN 99 L/100L E 20171231 64582-0001_69a81e62-78c0-4815-b1be-ba6c39305822 64582-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980420 UNAPPROVED MEDICAL GAS A & D Healthcare (Equipment Repair) OXYGEN 99 L/100L E 20171231 64588-0001_a2016ba9-708d-4fea-a47f-a0ddb9ce260a 64588-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19981003 UNAPPROVED MEDICAL GAS Corner Homecare OXYGEN 99 L/100L E 20171231 64597-301_78a92b6b-5d28-4ff4-8279-b0449c7a6d83 64597-301 HUMAN PRESCRIPTION DRUG NUEDEXTA dextromethorphan hydrobromide and quinidine sulfate CAPSULE, GELATIN COATED ORAL 20101201 NDA NDA021879 Avanir Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE 20; 10 mg/1; mg/1 Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 64597-311_12095cc5-64f4-43bc-9c6b-b152f4117e94 64597-311 HUMAN PRESCRIPTION DRUG ONZETRA sumatriptan succinate KIT NASAL 20151001 NDA NDA206099 Avanir Pharmaceuticals, Inc. N 20181231 64606-100_131e808b-418f-8dfc-59b5-a05dfa88474a 64606-100 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 19960101 UNAPPROVED MEDICAL GAS Norton Sound Health Corporation OXYGEN 93 mL/L E 20171231 64616-035_5f8aef7c-0665-6373-e053-2a91aa0a12a2 64616-035 HUMAN OTC DRUG Sinus Cleanser Sinus Relief LIQUID NASAL 20020507 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. BAPTISIA TINCTORIA ROOT 12 1/mL N 20181231 64616-037_8be28928-bf45-4427-99c9-a6e5a66d0136 64616-037 HUMAN PRESCRIPTION DRUG Olive Leaf Throat Throat Spray SPRAY ORAL 20030227 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. BAPTISIA TINCTORIA 4 [hp_X]/mL N 20181231 64616-038_5f8ae9ab-5e59-7a60-e053-2991aa0a9817 64616-038 HUMAN OTC DRUG Olive Leaf Throat Flavored Throat Spray SPRAY ORAL 20030227 UNAPPROVED HOMEOPATHIC Vitality Works, Inc BAPTISIA TINCTORIA 4 [hp_X]/mL N 20181231 64616-039_61f98b78-f82a-ac56-e053-2991aa0a62af 64616-039 HUMAN OTC DRUG Olive Leaf Nasal Nasal Spray SPRAY NASAL 20030107 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. BAPTISIA TINCTORIA 4 [hp_X]/mL N 20191231 64616-041_60dd4726-1e55-2d91-e053-2a91aa0aa0ff 64616-041 HUMAN OTC DRUG Cold and Infection Defense Nasal Throat Spray LIQUID NASAL 20031216 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ECHINACEA PURPUREA; ECHINACEA PURPUREA ROOT; BELLADONNA LEAF 4; 4; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-042_5f8af258-8de8-305d-e053-2a91aa0a6a72 64616-042 HUMAN OTC DRUG Olive-Viate Topical Skin Relief LIQUID TOPICAL 20040302 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. GRAPHITE; CALCIUM SULFIDE; TOXICODENDRON PUBESCENS LEAF; SULFUR 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-045_5f8ad9e0-de25-1c24-e053-2a91aa0ad070 64616-045 HUMAN OTC DRUG Earache Remedy Ear Drops LIQUID AURICULAR (OTIC) 20040823 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; POTASSIUM CHLORIDE; PLANTAGO MAJOR; MATRICARIA RECUTITA; VERBASCUM THAPSUS 6; 3; 3; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-046_5f8ad9e0-ddbe-1c24-e053-2a91aa0ad070 64616-046 HUMAN OTC DRUG Bye Bye Burns Topical Skin Spray SPRAY TOPICAL 20040823 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ATROPA BELLADONNA; LYTTA VESICATORIA; RANUNCULUS BULBOSUS; URTICA DIOICA 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-047_5f8ae9ab-5e4f-7a60-e053-2991aa0a9817 64616-047 HUMAN OTC DRUG Bye Bye Diaper Rash Diaper Rash Treatment LIQUID TOPICAL 20051026 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. SULFUR; CALCIUM SULFIDE; TOXICODENDRON PUBESCENS LEAF; LYTTA VESICATORIA 12; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-048_5f8ae9ab-5e63-7a60-e053-2991aa0a9817 64616-048 HUMAN OTC DRUG Stop Rash Adult Skin Relief LIQUID TOPICAL 20060506 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. SULFUR; CALCIUM SULFIDE; TOXICODENDRON PUBESCENS LEAF; LYTTA VESICATORIA 12; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-050_5f8ad9e0-de2f-1c24-e053-2a91aa0ad070 64616-050 HUMAN OTC DRUG Pediatric Earache Remedy Ear Drops LIQUID AURICULAR (OTIC) 20061023 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ACONITUM NAPELLUS; ATROPA BELLADONNA; POTASSIUM CHLORIDE; PLANTAGO MAJOR; MATRICARIA RECUTITA; VERBASCUM THAPSUS 6; 3; 3; 3; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-055_5faf6242-1a32-5853-e053-2a91aa0a9000 64616-055 HUMAN OTC DRUG Olive Vaginal Formula Olive Leaf Vaginal Spray SPRAY VAGINAL 20100210 UNAPPROVED HOMEOPATHIC Vitality Works, Inc SODIUM BORATE; CHAMAELIRIUM LUTEUM ROOT; WOOD CREOSOTE; PLATINUM 8; 8; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-056_5faf5b79-4dfd-5a55-e053-2991aa0a5833 64616-056 HUMAN PRESCRIPTION DRUG Olive Rectal Formula Olive Rectal Spray SPRAY RECTAL 20091002 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. HORSE CHESTNUT; ALOE; ACTIVATED CHARCOAL; GAMBOGE; SULFUR 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-069_5faf6242-1a41-5853-e053-2a91aa0a9000 64616-069 HUMAN OTC DRUG Olive Leaf Acne Remedy Topical Skin Relief LIQUID TOPICAL 20110420 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ANTIMONY TRISULFIDE; CALCIUM SULFATE ANHYDROUS; JUGLANS REGIA FLOWERING TOP; SULFUR IODIDE 12; 12; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-070_5faf6242-1a4b-5853-e053-2a91aa0a9000 64616-070 HUMAN OTC DRUG Cut and Wound Remedy Topical Cut and Wound Relief SPRAY TOPICAL 20110718 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG 6; 1; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-072_5fafa0ed-d174-637c-e053-2991aa0a6f60 64616-072 HUMAN OTC DRUG Formula 3 Cough Syrup Cough Syrup LIQUID ORAL 20100707 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. PELARGONIUM SIDOIDES ROOT; PRUNUS SEROTINA BARK; SAMBUCUS NIGRA FLOWER 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-077_e04ca1f3-ff9c-4a36-bca0-66a03e331187 64616-077 HUMAN PRESCRIPTION DRUG Slenderiix Weight Management Formula LIQUID ORAL 20120516 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. AVENA SATIVA FLOWERING TOP; AMMONIUM BROMIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; FUCUS VESICULOSUS; GRAPHITE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SULFURIC ACID; THYROID, UNSPECIFIED 6; 12; 6; 6; 12; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 64616-079_5faf6506-0cb0-5851-e053-2a91aa0a811d 64616-079 HUMAN OTC DRUG ADR-Bal Adrenal Support LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ALETRIS FARINOSA ROOT; FENNEL SEED; SALIX NIGRA BARK; WYETHIA HELENIOIDES ROOT; WOOD TAR HYDROCARBON DISTILLATE 7; 15; 15; 20; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-080_5faf6494-0b73-637e-e053-2991aa0a8a22 64616-080 HUMAN OTC DRUG Al-Inflam Joint Support LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ANAGALLIS ARVENSIS; SILVER NITRATE; HAWTHORN LEAF WITH FLOWER; CROTALUS HORRIDUS HORRIDUS VENOM; PASSIFLORA INCARNATA FLOWERING TOP; PLATINUM; URTICA URENS 10; 15; 20; 20; 15; 12; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-081_5faf3dff-8bf7-30a6-e053-2a91aa0aeb75 64616-081 HUMAN OTC DRUG Brain Supp Brain Support LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. GARLIC; ARISAEMA TRIPHYLLUM ROOT; IRON; GOLDENSEAL; LATHYRUS SATIVAS SEED; EGG PHOSPHOLIPIDS; PHOSPHORUS; SANTONIN; SUS SCROFA PITUITARY GLAND; CHOLESTEROL; VALERIAN; CINCHONA OFFICINALIS BARK 6; 6; 10; 6; 10; 8; 12; 10; 6; 10; 10; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 64616-082_615773bc-088d-fc39-e053-2a91aa0af00f 64616-082 HUMAN OTC DRUG Category I Immune System Booster LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ACTAEA SPICATA ROOT; ANAGALLIS ARVENSIS; ARGEMONE MEXICANA; CANDIDA ALBICANS; HELODERMA HORRIDUM VENOM; HYOSCYAMUS NIGER; POTASSIUM DICHROMATE; POTASSIUM IODIDE; POTASSIUM NITRATE; POTASSIUM PHOSPHATE, DIBASIC; SENNA LEAF; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 6; 15; 17; 14; 5; 10; 10; 10; 10; 7; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-083_5faf3dff-8c00-30a6-e053-2a91aa0aeb75 64616-083 HUMAN OTC DRUG Category II Immune System Booster LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc CHASTE TREE; ARALIA RACEMOSA ROOT; ARUNDO PLINIANA ROOT; EUPHORBIA RESINIFERA RESIN; ERIODICTYON CALIFORNICUM LEAF; GAMBOGE; MERCURIC CHLORIDE; MERCURIC CYANIDE; MERCURIC IODIDE; MERCURY; PAEONIA OFFICINALIS ROOT; PINE TAR; LEAD; SELENIUM; LYCOSA TARANTULA; THYROID, UNSPECIFIED; TRILLIUM ERECTUM ROOT 3; 6; 6; 14; 3; 7; 10; 15; 10; 10; 15; 10; 10; 15; 15; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 64616-084_5faf6e49-5a58-4c5d-e053-2991aa0ac711 64616-084 HUMAN OTC DRUG Category III Immune System Booster LIQUID ORAL 20130313 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; ARTEMISIA VULGARIS ROOT; GOLD; ACTIVATED CHARCOAL; CHIONANTHUS VIRGINICUS BARK; CORALLIUM RUBRUM EXOSKELETON; EGG PHOSPHOLIPIDS; MORELLA CERIFERA ROOT BARK; ORNITHOGALUM UMBELLATUM; PETROSELINUM CRISPUM; SANGUINARIA CANADENSIS ROOT 10; 10; 9; 10; 12; 7; 15; 15; 7; 10; 10; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-085_5faf6e49-5a62-4c5d-e053-2991aa0ac711 64616-085 HUMAN OTC DRUG Category IV Immune System Booster LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACTAEA SPICATA ROOT; ALOE; LYTTA VESICATORIA; CUPRIC ARSENITE; COPPER; SOLANUM DULCAMARA TOP; SKIM MILK; FRAXINUS AMERICANA BARK; URTICA URENS; ZINC 6; 7; 7; 15; 10; 5; 20; 8; 5; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-086_60cd0973-f70a-2b70-e053-2a91aa0a4361 64616-086 HUMAN OTC DRUG Category V Immune System Booster LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc, EPINEPHRINE; ANAGALLIS ARVENSIS; CHAMAEMELUM NOBILE; ARSENIC TRIIODIDE; CALCIUM LACTATE; ANHYDROUS CITRIC ACID; COPPER; FRAXINUS AMERICANA BARK; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; AQUA REGIA; PETROSELINUM CRISPUM; PICRIC ACID; SALICYLIC ACID; SALIX NIGRA BARK; LACTIC ACID; DELPHINIUM STAPHISAGRIA SEED; URANYL NITRATE HEXAHYDRATE 15; 3; 20; 10; 50; 15; 25; 4; 4; 8; 14; 15; 20; 12; 12; 20; 15; 5; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-087_60cce2fb-b234-7bb0-e053-2a91aa0a66c2 64616-087 HUMAN OTC DRUG CL-N Emotional Health Booster LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACONITUM NAPELLUS; AMBERGRIS; AMMI VISNAGA FRUIT; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BELLIS PERENNIS; BERBERIS VULGARIS ROOT BARK; CAUSTICUM; MATRICARIA RECUTITA; CHELIDONIUM MAJUS; CLEMATIS RECTA FLOWERING TOP; MARSDENIA CONDURANGO BARK; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; FENNEL SEED; FRAXINUS AMERICANA BARK; LILIUM LANCIFOLIUM WHOLE FLOWERING; MERCURIC CHLORIDE; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; SCROPHULARIA NODOSA; BLACK MUSTARD SEED; VERATRUM ALBUM ROOT 6; 12; 10; 15; 6; 12; 12; 15; 10; 10; 5; 7; 3; 30; 17; 12; 10; 12; 10; 5; 15; 7; 10; 7; 15; 7; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-088_60ccfb82-9cd7-6636-e053-2991aa0afcda 64616-088 HUMAN OTC DRUG ENC Emotional Health Booster LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. HORSE CHESTNUT; CHASTE TREE; IRIS VERSICOLOR ROOT; MANGANESE ACETATE TETRAHYDRATE; MERCURIC CYANIDE; ORNITHOGALUM UMBELLATUM; SELENIUM; ANGUILLA ROSTRATA BLOOD SERUM; THYROID, UNSPECIFIED; ZINC 10; 10; 10; 14; 14; 20; 30; 8; 6; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 64616-089_60cd209b-4a3d-4fd9-e053-2a91aa0a4c7d 64616-089 HUMAN OTC DRUG Epl-Cell Repair Cell Repair Aid LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. SEMECARPUS ANACARDIUM JUICE; ARTEMISIA VULGARIS ROOT; ASAFETIDA; BENZENE; CALCIUM CHLORIDE; CALCIUM PICRATE; JACOBAEA MARITIMA; PROTORTONIA CACTI; FUCUS VESICULOSUS; NITROGLYCERIN; CHAMAELIRIUM LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM; VIBURNUM OPULUS BARK; FUMARIA OFFICINALIS FLOWERING TOP 7; 7; 7; 20; 10; 10; 7; 10; 7; 15; 7; 6; 10; 10; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-090_60cd209b-4a33-4fd9-e053-2a91aa0a4c7d 64616-090 HUMAN PRESCRIPTION DRUG Fem Repair Non-Preg Fem Glandular and Tissue Aid LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ANTIMONY ARSENATE; CHRYSOPOGON ZIZANIOIDES ROOT; CHIONANTHUS VIRGINICUS BARK; GENTIANA LUTEA ROOT; CENTELLA ASIATICA; POTASSIUM PHOSPHATE, DIBASIC; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; OXALIC ACID DIHYDRATE; SUS SCROFA PITUITARY GLAND; RUTA GRAVEOLENS FLOWERING TOP; CLAVICEPS PURPUREA SCLEROTIUM; SOLIDAGO VIRGAUREA FLOWERING TOP; VALERIANA OFFICINALIS WHOLE; ZINC OXIDE 14; 6; 6; 6; 6; 20; 12; 15; 10; 6; 6; 7; 20; 6; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20181231 64616-091_60cd209b-4a24-4fd9-e053-2a91aa0a4c7d 64616-091 HUMAN OTC DRUG Fem Response Female Reproductive Booster LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. APOCYNUM CANNABINUM ROOT; ARALIA RACEMOSA ROOT; BELLIS PERENNIS; PAPAYA SEED; CUPRIC ARSENITE; LACTIC ACID, DL-; JUNIPERUS SABINA LEAFY TWIG; WYETHIA HELENIOIDES ROOT 7; 30; 20; 8; 10; 10; 20; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-092_60ccb677-4743-0e09-e053-2991aa0af799 64616-092 HUMAN OTC DRUG GDS-Calm Digestive Balance LIQUID ORAL 20130417 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. HORSE CHESTNUT; CHRYSOPOGON ZIZANIOIDES ROOT; CHAMAEMELUM NOBILE; CANDIDA ALBICANS; HELIANTHEMUM CANADENSE; SYZYGIUM JAMBOS SEED; LILIUM LANCIFOLIUM WHOLE FLOWERING; VIROLA SEBIFERA RESIN; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; ROBINIA PSEUDOACACIA BARK 7; 7; 14; 14; 8; 7; 15; 7; 6; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-093_60ccb677-4739-0e09-e053-2991aa0af799 64616-093 HUMAN OTC DRUG HCB-Res Heart,Circulatory System and Blood Booster LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. SEMECARPUS ANACARDIUM JUICE; MILK THISTLE; MARSDENIA CONDURANGO BARK; GALIUM APARINE; HELODERMA HORRIDUM VENOM; KALMIA LATIFOLIA LEAF; KEROSENE; SALIX NIGRA BARK; VERATRUM VIRIDE ROOT; VERBENA OFFICINALIS 5; 7; 3; 7; 15; 10; 15; 10; 10; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-094_60cd1e01-946e-3f3b-e053-2a91aa0a8016 64616-094 HUMAN OTC DRUG HCB-Tone Heart Muscle Aid LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. SEMECARPUS ANACARDIUM JUICE; CAMPHOR (NATURAL); PAPAYA SEED; MARSDENIA CONDURANGO BARK; GALIUM APARINE; HELODERMA HORRIDUM VENOM; KEROSENE; SALIX NIGRA BARK; VERATRUM VIRIDE ROOT; VERBENA OFFICINALIS 6; 9; 8; 4; 10; 15; 15; 10; 10; 7 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-095_60cd209b-49e9-4fd9-e053-2a91aa0a4c7d 64616-095 HUMAN OTC DRUG L-Trans Lymph System Booster LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. SILVER; ARNICA MONTANA; ARSENIC TRIIODIDE; BAPTISIA TINCTORIA; BENZENE; COBALT; CRATAEGUS FRUIT; SYZYGIUM JAMBOS SEED; EUPATORIUM PERFOLIATUM FLOWERING TOP; FRAXINUS AMERICANA BARK; HYOSCYAMUS NIGER; LEDUM PALUSTRE TWIG; VERONICASTRUM VIRGINICUM ROOT; NICOTINE; SARSAPARILLA; TURPENTINE OIL; TEUCRIUM MARUM; CAPSELLA BURSA-PASTORIS; VIBURNUM OPULUS BARK 14; 8; 14; 10; 12; 14; 10; 7; 10; 7; 7; 10; 15; 12; 10; 20; 6; 10; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-096_60cd0973-f714-2b70-e053-2a91aa0a4361 64616-096 HUMAN OTC DRUG Lung-Resp Cough Relief LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc ARSENIC TRIOXIDE; LYCOPERDON UTRIFORME FRUITING BODY; BROMINE; GERANIUM MACULATUM ROOT; IPECAC; LACTUCA VIROSA; MYRTUS COMMUNIS TOP; SALIX NIGRA BARK; WYETHIA HELENIOIDES ROOT 15; 10; 10; 12; 15; 20; 20; 10; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-097_60cce2fb-b227-7bb0-e053-2a91aa0a66c2 64616-097 HUMAN OTC DRUG LV-FX Liver Assit LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc HORSE CHESTNUT; ANACARDIUM OCCIDENTALE FRUIT; ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; BELLIS PERENNIS; CALCIUM FLUORIDE; MILK THISTLE; SIMABA CEDRON SEED; CHAMAELIRIUM LUTEUM ROOT; LEDUM PALUSTRE TWIG; MANGANESE ACETATE TETRAHYDRATE; MYRTUS COMMUNIS TOP; PHYSALIS ALKEKENGI FRUIT; RUTA GRAVEOLENS FLOWERING TOP; SELENIUM; FERULA SUMBUL ROOT; THYROID, UNSPECIFIED; VERATRUM VIRIDE ROOT 10; 14; 10; 15; 15; 7; 20; 15; 9; 10; 20; 20; 6; 7; 10; 30; 14; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 64616-098_60cccbdc-35ba-4703-e053-2a91aa0aa599 64616-098 HUMAN OTC DRUG MALE-PROS Prostrate Booster LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACTAEA SPICATA ROOT; ANTIMONY TRISULFIDE; SILVER NITRATE; ARNICA MONTANA; CHELIDONIUM MAJUS; CLEMATIS RECTA FLOWERING TOP; CYPRIPEDIUM PARVIFOLUM ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MERCURIC CYANIDE; MERCURIUS SOLUBILIS; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; OCIMUM AMERICANUM LEAF; KEROSENE; VERATRUM ALBUM ROOT; ZINC OXIDE 10; 9; 15; 7; 6; 15; 14; 70; 7; 14; 12; 20; 15; 10; 6; 6 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-099_60dd4f4b-7129-385e-e053-2a91aa0ad5d6 64616-099 HUMAN OTC DRUG NRV-Systemic Nervouse System Aid LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. EPINEPHRINE; SILVER IODIDE; SILVER; SILVER NITRATE; ATROPINE; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; POTASSIUM ARSENITE ANHYDROUS; ORNITHOGALUM UMBELLATUM; PILOCARPUS JABORANDI LEAF; KRAMERIA LAPPACEA ROOT; SEMPERVIVUM TECTORUM LEAF; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 20; 14; 10; 10; 14; 6; 8; 7; 18; 10; 7; 10; 10; 3; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-100_60cca331-ce8f-13dc-e053-2a91aa0a09fa 64616-100 HUMAN OTC DRUG OP-P Emotional Health Booster LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACONITUM LYCOCTONUM; ALOE; ALUMINUM OXIDE; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM OXALATE MONOHYDRATE; BLACK COHOSH; DROSERA ROTUNDIFOLIA; ECHINACEA PURPUREA; GAMBOGE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM CHLORIDE; LACHESIS MUTA VENOM; LOBELIA INFLATA; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PARAFFIN; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PULSATILLA PRATENSIS; SCUTELLARIA LATERIFLORA; SENNA LEAF; SULFURIC ACID; USTILAGO MAYDIS 5; 10; 10; 10; 15; 8; 12; 12; 15; 6; 12; 6; 12; 10; 5; 10; 6; 15; 6; 10; 15; 30; 30; 30; 27; 5; 14; 2; 7; 10; 10; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-101_60cca8dd-45ea-1a4f-e053-2a91aa0ae59f 64616-101 HUMAN OTC DRUG Pan-Zyme-S Pancreas Balance LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ARNICA MONTANA ROOT; CRATAEGUS FRUIT; ETHER; WOOD CREOSOTE; LILIUM LANCIFOLIUM WHOLE FLOWERING; MANGANESE ACETATE TETRAHYDRATE; PARAFFIN; PLANTAGO MAJOR; SANGUINARIA CANADENSIS ROOT; SILICON DIOXIDE; THYROID, UNSPECIFIED; VALERIAN 5; 10; 10; 10; 10; 15; 14; 10; 10; 45; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 64616-102_60cc7d89-de47-ea97-e053-2a91aa0a50d9 64616-102 HUMAN OTC DRUG Para-BN Parathyroid Booster LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ALFALFA; ARSENIC TRIOXIDE; SODIUM TETRACHLOROAURATE; CALCIUM HYDROXIDE; CALCIUM FLUORIDE; CALCIUM IODIDE; CALCIUM OXALATE MONOHYDRATE; CROTON TIGLIUM SEED; POTASSIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PODOPHYLLUM; TEUCRIUM MARUM; URANYL NITRATE HEXAHYDRATE 7; 30; 20; 20; 12; 12; 20; 6; 10; 10; 7; 10; 17 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-103_60cca331-cea8-13dc-e053-2a91aa0a09fa 64616-103 HUMAN OTC DRUG Renal Supp-RDP Kidney Support LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. AMMONIUM CHLORIDE; AMMONIUM PHOSPHATE, DIBASIC; ARTEMISIA VULGARIS ROOT; ARISAEMA TRIPHYLLUM ROOT; ASAFETIDA; BARIUM CHLORIDE DIHYDRATE; CALCIUM OXALATE MONOHYDRATE; HELLEBORUS FOETIDUS ROOT; JUGLANS REGIA LEAF; POTASSIUM NITRATE; KALMIA LATIFOLIA LEAF; ACHILLEA MILLEFOLIUM; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; PASSIFLORA INCARNATA FLOWERING TOP; SEPIA OFFICINALIS JUICE 12; 20; 10; 15; 10; 10; 25; 100; 7; 30; 30; 7; 14; 10; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-104_60cc8607-b257-f358-e053-2a91aa0a5e5b 64616-104 HUMAN OTC DRUG RPT-Sys Emotional Rebalance LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. APOCYNUM CANNABINUM ROOT; ASAFETIDA; SODIUM BORATE; EUCALYPTUS GLOBULUS LEAF; GENTIANA LUTEA ROOT; STRYCHNOS IGNATII SEED; WOOD CREOSOTE; LATHYRUS SATIVAS SEED; EGG PHOSPHOLIPIDS; LYCOPODIUM CLAVATUM SPORE; NUTMEG; OXALIC ACID DIHYDRATE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; PLATINUM; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; THYROID, UNSPECIFIED; TRILLIUM ERECTUM ROOT 10; 6; 7; 7; 7; 10; 8; 20; 20; 7; 7; 10; 8; 6; 10; 10; 10; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 64616-105_60cca8dd-45de-1a4f-e053-2a91aa0ae59f 64616-105 HUMAN OTC DRUG Sweep Detoxifying LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. AMMI VISNAGA FRUIT; CARBO ANIMALIS; ACTIVATED CHARCOAL; QUININE ARSENATE; CITRULLUS COLOCYNTHIS FRUIT PULP; POTASSIUM ARSENITE ANHYDROUS; DAPHNE MEZEREUM BARK; NITRIC ACID; PALLADIUM; PLATINUM; SMILAX REGELII ROOT; SELENIUM 10; 20; 10; 14; 7; 20; 10; 20; 14; 15; 15; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-106_60cca331-ce70-13dc-e053-2a91aa0a09fa 64616-106 HUMAN OTC DRUG THY-Plex Thyroid Support LIQUID ORAL 20130408 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. CHRYSOPOGON ZIZANIOIDES ROOT; BARIUM IODIDE; CALCIUM ACETATE; CALENDULA OFFICINALIS FLOWERING TOP; GALLIC ACID MONOHYDRATE; GAMBOGE; HYOSCYAMUS NIGER; POTASSIUM IODIDE; AQUA REGIA; PHYSOSTIGMA VENENOSUM SEED; SCHOENOCAULON OFFICINALE SEED; THYROID, UNSPECIFIED; URTICA URENS; ZINC OXIDE 10; 18; 10; 3; 12; 5; 12; 12; 15; 10; 10; 6; 5; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-107_60cc7d89-de3d-ea97-e053-2a91aa0a50d9 64616-107 HUMAN OTC DRUG TLB-Matrix Joint Booster LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. PICEA MARIANA RESIN; GOLD; ATROPA BELLADONNA; FERRIC PICRATE; PUNICA GRANATUM ROOT BARK; LAMIUM ALBUM; PULSATILLA VULGARIS; THYROID, UNSPECIFIED; URTICA URENS; VIBURNUM OPULUS BARK; ZINC OXIDE 15; 15; 15; 15; 10; 7; 15; 6; 7; 14; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-108_60cc9024-1991-4567-e053-2991aa0a7562 64616-108 HUMAN OTC DRUG Vital-FL Body Fluid Balance LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC Vitaltiy Works, Inc. ARISAEMA TRIPHYLLUM ROOT; CALCIUM FLUORIDE; FERRIC PICRATE; GENTIANA LUTEA ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYOSCYAMUS NIGER; WOOD CREOSOTE; CANIS LUPUS FAMILIARIS MILK; LACTUCA VIROSA; SODIUM CHLORIDE; SULFUR IODIDE; TEUCRIUM MARUM; CAPSELLA BURSA-PASTORIS; VALERIAN 7; 10; 15; 7; 60; 5; 8; 20; 5; 15; 15; 7; 7; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-109_60cca331-ce9d-13dc-e053-2a91aa0a09fa 64616-109 HUMAN OTC DRUG Cal-5-Revive Calcium Balance LIQUID ORAL 20130320 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. ACONITUM NAPELLUS; BISMUTH SUBNITRATE; CALCIUM ARSENATE; CALCIUM HYDROXIDE; CALCIUM FLUORIDE; CALCIUM IODIDE; CALCIUM OXALATE MONOHYDRATE; ELAEIS GUINEENSIS FRUIT; HELIANTHUS ANNUUS FLOWERING TOP; HYDRANGEA ARBORESCENS ROOT; IPECAC; IRIS GERMANICA VAR. FLORENTINA ROOT; POTASSIUM ARSENITE ANHYDROUS; POTASSIUM CHLORATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; MERCURIUS SOLUBILIS; OSMIUM; PHOSPHORIC ACID; SANGUINARINE NITRATE; TELLURIUM; ZINC GLUCONATE 20; 15; 12; 27; 25; 10; 30; 20; 22; 14; 24; 23; 20; 30; 22; 22; 30; 22; 36; 17; 27; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-111_60ccab62-378c-1e35-e053-2a91aa0af788 64616-111 HUMAN OTC DRUG Sore Muscle and Joint Relief Muscle and Joint Remedy LIQUID ORAL 20130404 UNAPPROVED HOMEOPATHIC Vitaltiy Works, Inc. ARNICA MONTANA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; POTASSIUM IODIDE; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; ZINC OXIDE 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 64616-113_5fb2ddea-169f-3749-e053-2991aa0a76e4 64616-113 HUMAN OTC DRUG CalmEase Rescue Remedy CalmEase Rescue Remedy LIQUID ORAL 20100122 UNAPPROVED HOMEOPATHIC vitality Works IMPATIENS GLANDULIFERA FLOWER; CLEMATIS VITALBA WHOLE; HELIANTHEMUM NUMMULARIUM FLOWER; PRUNUS CERASIFERA FLOWER; ORNITHOGALUM UMBELLATUM 7; 7; 7; 7; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 64616-115_21b44c37-4fc9-14b4-e054-00144ff8d46c 64616-115 HUMAN OTC DRUG Comfort for Teething Comfort for Teething LIQUID ORAL 20130705 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED; CHAMOMILE; ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; WOOD CREOSOTE; RHEUM OFFICINALE ROOT 6; 3; 6; 6; 6; 6 [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL N 20181231 64616-116_220209c1-18ac-1b78-e054-00144ff8d46c 64616-116 HUMAN OTC DRUG Comfort for Colic Comfort for Kids LIQUID ORAL 20130705 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. PULSATILLA PRATENSIS; AETHUSA CYNAPIUM; DIOSCOREA VILLOSA TUBER; MAGNESIUM PHOSPHATE, DIBASIC; CHAMOMILE; CITRULLUS COLOCYNTHIS FRUIT 4; 4; 6; 6; 4; 4 [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL; [hp_X]/.05mL N 20181231 64616-117_2d796691-adc6-52b3-e054-00144ff8d46c 64616-117 HUMAN OTC DRUG RadDefense 2 RadDefense2 LIQUID ORAL 20160224 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. RHEUM PALMATUM ROOT; CALIFORNIUM CF-249; EUPATORIUM PERFOLIATUM FLOWERING TOP 30; 30; 30 [hp_C]/.03mL; [hp_C]/.03mL; [hp_C]/.03mL N 20181231 64616-118_2d7ea007-ef24-4b16-e054-00144ff8d46c 64616-118 HUMAN OTC DRUG RadDefense1 RadDefense1 LIQUID ORAL 20160302 UNAPPROVED HOMEOPATHIC Vitality Works, Inc. VISCUM ALBUM WHOLE; STRYCHNOS NUX-VOMICA SEED; URANYL NITRATE HEXAHYDRATE 30; 30; 30 [hp_C]/29.6mL; [hp_C]/29.6mL; [hp_C]/29.6mL N 20181231 64616-119_45ade734-f447-4370-e054-00144ff88e88 64616-119 HUMAN OTC DRUG Gripe Water Gripe Water LIQUID ORAL 20170131 UNAPPROVED HOMEOPATHIC Vitality Works MATRICARIA CHAMOMILLA WHOLE; MENTHA PIPERITA; ZINGIBER OFFICINALE WHOLE; FOENICULUM VULGARE VAR. VULGARE WHOLE 1; 1; 1; 1 [hp_X]/.0025mL; [hp_X]/.0025mL; [hp_X]/.0025mL; [hp_X]/.0025mL N 20181231 64631-7701_c9b45fea-b13a-4635-8316-a54772692866 64631-7701 HUMAN OTC DRUG RENEWAL HGH ADVANCED RNA, Silicea, Phosphoricum Acidum, Pituitaria Glandula (Suis), Sulphur, Zincum Sulphuricum, HGH, Selenium Metallicum, Colostrum (Human) LIQUID ORAL 20150120 UNAPPROVED HOMEOPATHIC Always Young, LLC. SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE; PHOSPHORIC ACID; SUS SCROFA PITUITARY GLAND; SULFUR; ZINC SULFATE HEPTAHYDRATE; SOMATROPIN; SELENIUM; HUMAN COLOSTRUM 9; 9; 9; 9; 14; 16; 30; 5; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 64646-001_5d52022d-d709-625a-e053-2a91aa0a2610 64646-001 HUMAN OTC DRUG OPTISOURCE Antibacterial Foam Hand Benzalkonium Chloride SOAP TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part333E Charlotte Products Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 64650-345_dac3bce9-9e22-4309-a6a9-e0495e328299 64650-345 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19710101 UNAPPROVED MEDICAL GAS Atlantic Welding Supply OXYGEN 99 L/100L E 20171231 64656-0250_a8d4ae0c-b0f2-408d-acb0-7b389e970b4f 64656-0250 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Mercy Home Care-HME OXYGEN 99 L/100L E 20171231 64661-650_446ae830-7a84-4283-b0d1-9a9bf22d0af0 64661-650 HUMAN PRESCRIPTION DRUG EnBrace HR LEVOMEFOLATE MAGNESIUM, LEUCOVORIN, FOLIC ACID, FERROUS CYSTEINE GLYCINATE, MAGNESIUM ASCORBATE, ZINC ASCORBATE, COCARBOXYLASE, FLAVIN ADENINE DINUCLEOTIDE, NADH, PYRIDOXAL PHOSPHATE ANHYDROUS, COBAMAMIDE, BETAINE, MAGNESIUM L-THREONATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, and PHOSPHATIDYL SERINE CAPSULE, DELAYED RELEASE PELLETS ORAL 20150408 UNAPPROVED DRUG OTHER JAYMAC Pharmaceuticals, LLC LEVOMEFOLATE MAGNESIUM; LEUCOVORIN; FOLIC ACID; FERROUS CYSTEINE GLYCINATE; MAGNESIUM ASCORBATE; ZINC ASCORBATE; COCARBOXYLASE; FLAVIN ADENINE DINUCLEOTIDE; NADH; PYRIDOXAL PHOSPHATE ANHYDROUS; COBAMAMIDE; BETAINE; MAGNESIUM L-THREONATE; 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM; 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM; PHOSPHATIDYL SERINE 5.23; 2.5; 1; 13.6; 24; 1; 25; 25; 25; 25; 50; 500; 1; 6.4; 800; 12 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1 Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Methylating Activity [MoA],Methylating Agent [EPC] N 20181231 64661-711_c8146638-0c20-4387-ac9e-aff5cbc991ae 64661-711 HUMAN PRESCRIPTION DRUG EnLyte leucovorin, folic acid, levomefolate magnesium, ferrous cysteine glycinate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine calcium, phosphatidyl serine, pyridoxal 5-phosphate, flavin adenine dinucleotide, nadh, cobamamide, cocarboxylase (thiamine pyrophosphate), magnesium ascorbate, zinc ascorbate, magnesium l-threonate and betaine CAPSULE, DELAYED RELEASE PELLETS ORAL 20111001 UNAPPROVED DRUG OTHER Jaymac Pharmaceuticals LLC LEUCOVORIN; FOLIC ACID; LEVOMEFOLATE MAGNESIUM; FERROUS CYSTEINE GLYCINATE; 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM; 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM; PHOSPHATIDYL SERINE; PYRIDOXAL PHOSPHATE ANHYDROUS; FLAVIN ADENINE DINUCLEOTIDE; NADH; COBAMAMIDE; COCARBOXYLASE; MAGNESIUM ASCORBATE; ZINC ASCORBATE; MAGNESIUM L-THREONATE; BETAINE; CITRIC ACID MONOHYDRATE; SODIUM CITRATE 2.5; 1; 7; 13.6; 6.4; 800; 12; 25; 25; 25; 50; 25; 24; 1; 1; 500; 1.83; 3.67 mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Methylating Activity [MoA],Methylating Agent [EPC],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 64661-811_b55156d3-2850-423a-ab3e-f6db662afbdc 64661-811 HUMAN PRESCRIPTION DRUG Viva CT Prenatal FOLIC ACID, FERROUS FUMARATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, ZINC OXIDE, CUPRIC SULFATE ANHYDROUS, and Selenomethionine TABLET, CHEWABLE ORAL 20120501 UNAPPROVED DRUG OTHER JayMac Pharmaceuticals LLC FOLIC ACID; FERROUS FUMARATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; ZINC OXIDE; CUPRIC SULFATE ANHYDROUS; SELENOMETHIONINE 1; 28; 100; 400; 30; 3; 3; 50; 15; 20; 1; 50 mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] N 20181231 64678-211_f5796150-9f9e-11e5-a837-0800200c9a66 64678-211 VACCINE BioThrax BACILLUS ANTHRACIS INJECTION, SUSPENSION INTRAMUSCULAR; SUBCUTANEOUS 19701104 BLA BLA103821 Emergent BioDefense Operations Lansing, LLC BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS 100 ug/mL Live Attenuated Bacillus Anthracis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [Chemical/Ingredient],Anthrax Vaccines [Chemical/Ingredient] N 20181231 64679-012_8ca8b6f9-f3cb-444b-8a5a-29817346f0dd 64679-012 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170322 ANDA ANDA206996 Wockhardt USA LLC. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 64679-034_8ca8b6f9-f3cb-444b-8a5a-29817346f0dd 64679-034 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170322 ANDA ANDA206996 Wockhardt USA LLC. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 64679-050_3f8ed365-e606-4bea-ad68-0a04b27d4039 64679-050 HUMAN OTC DRUG React Levonorgestrel TABLET ORAL 20160413 ANDA ANDA202246 Wockhardt USA, LLC LEVONORGESTREL 1.5 mg/1 E 20171231 64679-056_8ca8b6f9-f3cb-444b-8a5a-29817346f0dd 64679-056 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170322 ANDA ANDA206996 Wockhardt USA LLC. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 64679-096_a6c75df5-3fdc-4a97-9aff-0fd2dede48c6 64679-096 HUMAN PRESCRIPTION DRUG AZACITIDINE azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20160929 ANDA ANDA207518 Wockhardt USA LLC. AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 64679-101_bd8f6923-d91b-4fdd-8aef-08d1bcc8579e 64679-101 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120515 ANDA ANDA201331 Wockhardt USA LLC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 64679-102_3842de3c-95fd-48f2-9448-93368ec9504d 64679-102 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121121 ANDA ANDA202189 Wockhardt USA LLC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 64679-105_bd8f6923-d91b-4fdd-8aef-08d1bcc8579e 64679-105 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120515 ANDA ANDA201331 Wockhardt USA LLC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 64679-107_bd8f6923-d91b-4fdd-8aef-08d1bcc8579e 64679-107 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (SR) Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120515 ANDA ANDA201331 Wockhardt USA LLC. BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 64679-121_2377358b-8cd4-4446-9a83-83c05986fa74 64679-121 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20150904 ANDA ANDA090073 Wockhardt USA LLC. MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 64679-122_2377358b-8cd4-4446-9a83-83c05986fa74 64679-122 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20150904 ANDA ANDA090073 Wockhardt USA LLC. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 64679-123_2377358b-8cd4-4446-9a83-83c05986fa74 64679-123 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride KIT 20150904 ANDA ANDA090073 Wockhardt USA LLC. N 20181231 64679-140_97b8df43-8933-4052-aaba-2f26c85334da 64679-140 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120518 ANDA ANDA202727 Wockhardt USA LLC. LANSOPRAZOLE 15 mg/1 N 20181231 64679-152_85e9a6f9-2629-47f3-a928-1e6e3526bf2d 64679-152 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20100524 ANDA ANDA090216 Wockhardt USA LLC. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 64679-153_85e9a6f9-2629-47f3-a928-1e6e3526bf2d 64679-153 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20100524 ANDA ANDA090216 Wockhardt USA LLC. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 64679-154_e5aa4d3e-9925-4d24-93ed-69a16f88601c 64679-154 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64679-155_e5aa4d3e-9925-4d24-93ed-69a16f88601c 64679-155 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64679-171_e5aa4d3e-9925-4d24-93ed-69a16f88601c 64679-171 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64679-172_e5aa4d3e-9925-4d24-93ed-69a16f88601c 64679-172 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64679-174_e5aa4d3e-9925-4d24-93ed-69a16f88601c 64679-174 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64679-175_e5aa4d3e-9925-4d24-93ed-69a16f88601c 64679-175 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64679-177_e5aa4d3e-9925-4d24-93ed-69a16f88601c 64679-177 HUMAN PRESCRIPTION DRUG ROPINIROLE HYDROCHLORIDE ropinirole hydrochloride TABLET, FILM COATED ORAL 20080529 ANDA ANDA079050 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64679-185_c193a124-ecc2-41b9-a77f-bbd986fabfb4 64679-185 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20130302 ANDA ANDA203070 Wockhardt USA LLC. ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 64679-186_c907d0ec-5b8c-4cdf-a1e1-7defbe385f2f 64679-186 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION INTRAVENOUS 20130302 ANDA ANDA203069 Wockhardt USA LLC. ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 64679-209_0fe68d55-9607-4271-95de-395b13eabeb4 64679-209 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20080104 ANDA ANDA077533 Wockhardt USA, LLC TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] E 20171231 64679-215_9f34c515-41b7-44f5-9aa6-8f4b281337a0 64679-215 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20120815 ANDA ANDA201948 Wockhardt USA LLC. DICLOFENAC SODIUM; MISOPROSTOL 50; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 64679-217_9f34c515-41b7-44f5-9aa6-8f4b281337a0 64679-217 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20120815 ANDA ANDA201948 Wockhardt USA LLC. DICLOFENAC SODIUM; MISOPROSTOL 75; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 64679-271_68c710e9-9052-47bc-a22b-9333611e2f94 64679-271 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt USA LLC. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 64679-272_68c710e9-9052-47bc-a22b-9333611e2f94 64679-272 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt USA LLC. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 64679-273_68c710e9-9052-47bc-a22b-9333611e2f94 64679-273 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt USA LLC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 64679-274_68c710e9-9052-47bc-a22b-9333611e2f94 64679-274 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt USA LLC. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 64679-275_68c710e9-9052-47bc-a22b-9333611e2f94 64679-275 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20121129 ANDA ANDA202498 Wockhardt USA LLC. LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 64679-290_d0c44896-c07c-401d-a4df-cb00b9e3b89b 64679-290 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120930 NDA AUTHORIZED GENERIC NDA020796 Wockhardt USA LLC. ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] E 20171231 64679-311_c5a39598-5e50-4b1d-8300-623d73cb9bda 64679-311 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA091267 Wockhardt USA LLC. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 64679-312_c5a39598-5e50-4b1d-8300-623d73cb9bda 64679-312 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA091267 Wockhardt USA LLC. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 64679-314_e809450e-7c94-4471-9507-4f9807b1a938 64679-314 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120814 ANDA ANDA202266 Wockhardt USA LLC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 64679-315_e809450e-7c94-4471-9507-4f9807b1a938 64679-315 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20121120 ANDA ANDA202266 Wockhardt USA LLC. CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 64679-363_e41228cf-9b83-4542-8108-d5234482ccba 64679-363 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride Olopatadine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20170628 ANDA ANDA200810 Wockhardt USA LLC. OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 64679-374_f9f5f626-1511-46eb-8d4d-584e1101f195 64679-374 HUMAN OTC DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20100806 ANDA ANDA090837 WOCKHARDT USA LLC. FAMOTIDINE 20 mg/1 N 20181231 64679-411_fec86421-10b5-4c1f-a9bc-06f9fac063a1 64679-411 HUMAN PRESCRIPTION DRUG FELODIPINE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101205 ANDA ANDA091484 WOCKHARDT USA LLC FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 64679-412_fec86421-10b5-4c1f-a9bc-06f9fac063a1 64679-412 HUMAN PRESCRIPTION DRUG FELODIPINE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101205 ANDA ANDA091484 WOCKHARDT USA LLC FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 64679-414_fec86421-10b5-4c1f-a9bc-06f9fac063a1 64679-414 HUMAN PRESCRIPTION DRUG FELODIPINE FELODIPINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101205 ANDA ANDA091484 WOCKHARDT USA LLC FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 64679-421_7ea85aa2-04e8-4f96-a241-f2821c967c4b 64679-421 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070906 ANDA ANDA078500 Wockhardt USA LLC. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 64679-422_7ea85aa2-04e8-4f96-a241-f2821c967c4b 64679-422 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070906 ANDA ANDA078500 Wockhardt USA LLC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 64679-423_7ea85aa2-04e8-4f96-a241-f2821c967c4b 64679-423 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070906 ANDA ANDA078500 Wockhardt USA LLC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 64679-433_003f6dd6-549c-448d-88e3-2ccd235692d2 64679-433 HUMAN PRESCRIPTION DRUG Pantoprazole sodium Pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 Wockhardt USA LLC. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 64679-434_003f6dd6-549c-448d-88e3-2ccd235692d2 64679-434 HUMAN PRESCRIPTION DRUG Pantoprazole sodium Pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20110119 ANDA ANDA091231 Wockhardt USA LLC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 64679-447_ff2b85cf-b092-4e19-b7a4-edc270d24050 64679-447 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE TABLET ORAL 20091211 ANDA ANDA078701 WOCKHARDT USA LLC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 64679-516_50dc0e88-ed66-4a6e-9c12-811ad5b66885 64679-516 HUMAN PRESCRIPTION DRUG TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE CAPSULE ORAL 20100427 ANDA ANDA078938 Wockhardt USA LLC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 64679-544_20ea0c1f-04a1-477d-a25b-ab02113e59cc 64679-544 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Wockhardt USA LLC. LEVOFLOXACIN 250 mg/1 N 20181231 64679-545_20ea0c1f-04a1-477d-a25b-ab02113e59cc 64679-545 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Wockhardt USA LLC. LEVOFLOXACIN 500 mg/1 N 20181231 64679-547_20ea0c1f-04a1-477d-a25b-ab02113e59cc 64679-547 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20110620 ANDA ANDA090367 Wockhardt USA LLC. LEVOFLOXACIN 750 mg/1 N 20181231 64679-553_b3eefb63-0cd7-4733-b75a-1088cc99e115 64679-553 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 Wockhardt USA LLC. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 64679-554_b3eefb63-0cd7-4733-b75a-1088cc99e115 64679-554 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 Wockhardt USA LLC. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 64679-555_b3eefb63-0cd7-4733-b75a-1088cc99e115 64679-555 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 Wockhardt USA LLC. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 64679-557_b3eefb63-0cd7-4733-b75a-1088cc99e115 64679-557 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 Wockhardt USA LLC. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 64679-571_b3eefb63-0cd7-4733-b75a-1088cc99e115 64679-571 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 Wockhardt USA LLC. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 64679-572_b3eefb63-0cd7-4733-b75a-1088cc99e115 64679-572 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081009 ANDA ANDA078871 Wockhardt USA LLC. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 64679-630_1d76032e-0273-405b-be46-a277d84cda79 64679-630 HUMAN PRESCRIPTION DRUG ADENOSINE ADENOSINE INJECTION INTRAVENOUS 20130330 ANDA ANDA079147 Wockhardt USA LLC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 64679-630_c228eecc-e21a-48e4-b775-d0ee282b3346 64679-630 HUMAN PRESCRIPTION DRUG ADENOSINE ADENOSINE INJECTION INTRAVENOUS 20090720 ANDA ANDA090220 WOCKHARDT USA LLC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 64679-631_272b3371-c817-4d05-a79b-27126ec9c512 64679-631 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride INJECTION INTRAVENOUS 20091117 ANDA ANDA090671 Wockhardt USA LLC. NICARDIPINE HYDROCHLORIDE 2.5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 64679-632_ef0b005f-898a-4944-a983-72fe170ab7c7 64679-632 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090986 Wockhardt USA LLC. OCTREOTIDE ACETATE 1000 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 64679-633_ef0b005f-898a-4944-a983-72fe170ab7c7 64679-633 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090985 Wockhardt USA LLC. OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 64679-634_ef0b005f-898a-4944-a983-72fe170ab7c7 64679-634 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090986 Wockhardt USA LLC. OCTREOTIDE ACETATE 200 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 64679-635_ef0b005f-898a-4944-a983-72fe170ab7c7 64679-635 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090985 Wockhardt USA LLC. OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 64679-636_ef0b005f-898a-4944-a983-72fe170ab7c7 64679-636 HUMAN PRESCRIPTION DRUG Octreotide acetate Octreotide acetate INJECTION INTRAVENOUS; SUBCUTANEOUS 20110511 ANDA ANDA090985 Wockhardt USA LLC. OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 64679-661_788cdf26-ee71-4201-b71a-6e8c2f76e6e2 64679-661 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080630 ANDA ANDA078564 Wockhardt USA LLC. GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 64679-661_adc047e8-428c-4353-8377-f2c92385f4f9 64679-661 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080630 ANDA ANDA078565 Wockhardt USA LLC. GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 64679-662_3baa2407-1d1a-4d73-8f2c-9079ae7be986 64679-662 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080303 ANDA ANDA078566 Wockhardt USA LLC. GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 64679-669_1efc676a-dc7b-4639-80e9-3ef90ea13f90 64679-669 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120914 ANDA ANDA202176 Wockhardt USA LLC. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 64679-670_1efc676a-dc7b-4639-80e9-3ef90ea13f90 64679-670 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120914 ANDA ANDA202176 Wockhardt USA LLC. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 64679-679_798f5504-7e2f-4078-acca-a80d8f4d9685 64679-679 HUMAN PRESCRIPTION DRUG Piperacillin and Tazobactam piperacillin sodium and tazobactam sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170320 ANDA ANDA207146 Wockhardt USA LLC. PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 36; 4.5 g/180mL; g/180mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 64679-692_c5df6afa-72eb-48f9-8a85-8b82644be291 64679-692 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE SOLUTION ORAL 20091014 ANDA ANDA078744 WOCKHARDT USA LLC. RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] E 20171231 64679-693_bd58a720-81d5-4358-a8d5-a835c600b60d 64679-693 HUMAN PRESCRIPTION DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SYRUP ORAL 20090828 ANDA ANDA078757 WOCKHARDT LLC. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 64679-694_d0dd386e-ee0f-4f52-b9cb-8fa709d14b0d 64679-694 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE SYRUP ORAL 20090526 ANDA ANDA079211 WOCKHARDT USA LLC RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 64679-698_b90ce134-cc1a-4da4-ad75-08e538ec76fd 64679-698 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170731 ANDA ANDA207147 Wockhardt USA LLC. OXACILLIN SODIUM 1 g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 64679-699_b90ce134-cc1a-4da4-ad75-08e538ec76fd 64679-699 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170731 ANDA ANDA207147 Wockhardt USA LLC. OXACILLIN SODIUM 2 g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 64679-700_097bd673-a2b9-4fa6-9d4d-dc92dd4532ba 64679-700 HUMAN PRESCRIPTION DRUG Oxacillin Oxacillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20171124 ANDA ANDA207148 Wockhardt USA LLC. OXACILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 64679-701_e448a92e-1aea-4691-a69c-bee4fa6e3850 64679-701 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Wockhardt USA LLC. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 64679-702_e448a92e-1aea-4691-a69c-bee4fa6e3850 64679-702 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Wockhardt USA LLC. CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 64679-703_e448a92e-1aea-4691-a69c-bee4fa6e3850 64679-703 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20070412 ANDA ANDA065391 Wockhardt USA LLC. CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 64679-711_2be5d938-5fbe-4088-89b7-eb28becdcd45 64679-711 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120816 ANDA ANDA078941 Wockhardt USA LLC. ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 64679-712_e39f04ec-3b27-414f-874d-ab5c50228022 64679-712 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET, FILM COATED ORAL 20070615 ANDA ANDA065428 Wockhardt USA LLC. CEFPROZIL 250 mg/1 N 20181231 64679-713_e39f04ec-3b27-414f-874d-ab5c50228022 64679-713 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET, FILM COATED ORAL 20070615 ANDA ANDA065428 Wockhardt USA LLC. CEFPROZIL 500 mg/1 N 20181231 64679-714_c412b3cc-0a2c-491f-8dfd-d81a76770928 64679-714 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070515 ANDA ANDA078426 Wockhardt USA LLC. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 64679-715_c412b3cc-0a2c-491f-8dfd-d81a76770928 64679-715 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070515 ANDA ANDA078426 Wockhardt USA LLC. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 64679-716_1a097c92-202a-42f1-8e1b-67270b441cfd 64679-716 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078865 Wockhardt USA LLC. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 64679-717_1a097c92-202a-42f1-8e1b-67270b441cfd 64679-717 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078865 Wockhardt USA LLC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 64679-718_1a097c92-202a-42f1-8e1b-67270b441cfd 64679-718 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110414 ANDA ANDA078865 Wockhardt USA LLC. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 64679-720_d2c223ad-1f57-4111-acae-bee711f4c8cd 64679-720 HUMAN PRESCRIPTION DRUG EXTENDED PHENYTOIN SODIUM EXTENDED PHENYTOIN SODIUM CAPSULE ORAL 20080130 ANDA ANDA040732 Wockhardt USA LLC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 64679-724_7400666a-3919-42e8-b907-c6e5c458175a 64679-724 HUMAN PRESCRIPTION DRUG Divalproex Sodium ER Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090210 ANDA ANDA078705 Wockhardt USA LLC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 64679-725_7400666a-3919-42e8-b907-c6e5c458175a 64679-725 HUMAN PRESCRIPTION DRUG Divalproex Sodium ER Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA078705 Wockhardt USA LLC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 64679-726_ae85d29f-df8a-4b46-998d-32453b20c0dc 64679-726 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20061227 ANDA ANDA077716 Wockhardt USA LLC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 64679-727_ae85d29f-df8a-4b46-998d-32453b20c0dc 64679-727 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20061227 ANDA ANDA077577 Wockhardt USA LLC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 64679-728_b6f826f7-ae35-4e70-907d-8b4ef561569b 64679-728 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate INJECTION SUBCUTANEOUS 20090206 ANDA ANDA078593 Wockhardt USA LLC. SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 64679-729_cc54268e-7687-455c-b57b-ef647c866f89 64679-729 HUMAN PRESCRIPTION DRUG FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20070806 ANDA ANDA078137 Wockhardt USA LLC. FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 64679-730_cc54268e-7687-455c-b57b-ef647c866f89 64679-730 HUMAN PRESCRIPTION DRUG FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20070806 ANDA ANDA078137 Wockhardt USA LLC. FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 64679-734_c9251b2d-9931-4bac-b780-85f2a4bbb7dc 64679-734 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt USA LLC. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 64679-735_c9251b2d-9931-4bac-b780-85f2a4bbb7dc 64679-735 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt USA LLC. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 64679-736_c9251b2d-9931-4bac-b780-85f2a4bbb7dc 64679-736 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt USA LLC. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 64679-737_c9251b2d-9931-4bac-b780-85f2a4bbb7dc 64679-737 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100722 ANDA ANDA090615 Wockhardt USA LLC. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 64679-738_af79c4ba-4a37-4d0c-ad25-a063834da83e 64679-738 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET ORAL 20120815 ANDA ANDA090221 Wockhardt USA LLC. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 64679-739_7f20bb5b-06a0-40b4-bd89-198236a5e18a 64679-739 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION INTRAVENOUS 20081030 ANDA ANDA077610 Wockhardt USA LLC. AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 64679-740_abe01bba-a7b9-4bcc-9393-e59b3dbd3e03 64679-740 HUMAN OTC DRUG RANITIDINE RANITIDINE TABLET, COATED ORAL 20080731 ANDA ANDA078884 WOCKHARDT USA LLC. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 64679-741_d1979a8e-c659-4cf6-ae3a-f4c0065b181c 64679-741 HUMAN OTC DRUG RANITIDINE RANITIDINE TABLET, COATED ORAL 20071126 ANDA ANDA078653 WOCKHARDT USA LLC. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 64679-742_ff2b85cf-b092-4e19-b7a4-edc270d24050 64679-742 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE HYDROCHLORIDE TABLET ORAL 20091211 ANDA ANDA078701 WOCKHARDT USA LLC. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 64679-743_fd17ec8a-f686-4f9b-9d88-6070da173f4d 64679-743 HUMAN PRESCRIPTION DRUG TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET ORAL 20070702 ANDA ANDA078229 Wockhardt USA LLC. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 64679-744_e8a55782-2ebf-4821-a954-928815fd80e9 64679-744 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt USA LLC. FEXOFENADINE HYDROCHLORIDE 30 mg/1 N 20181231 64679-744_fb544146-d163-43a2-9314-0b28cfbfd388 64679-744 HUMAN OTC DRUG ALLERGY 24-HR FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt USA LLC. FEXOFENADINE HYDROCHLORIDE 30 mg/1 N 20181231 64679-757_af0a37d4-9b29-4e3e-beda-c33957b7f0d2 64679-757 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20070327 ANDA ANDA077942 Wockhardt USA LLC. KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 64679-758_af0a37d4-9b29-4e3e-beda-c33957b7f0d2 64679-758 HUMAN PRESCRIPTION DRUG KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTION INTRAMUSCULAR; INTRAVENOUS 20070327 ANDA ANDA077942 Wockhardt USA LLC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 64679-759_04bf0b4f-f05f-43e8-8d70-4f504ef2959f 64679-759 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION INTRAMUSCULAR; INTRAVENOUS 20070322 ANDA ANDA077941 Wockhardt USA LLC. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 64679-760_78294e7e-bc6c-497a-8e17-4b3d6c377b39 64679-760 HUMAN PRESCRIPTION DRUG PROMETHAZINE HCL promethazine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20091223 ANDA ANDA040785 Wockhardt USA LLC. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 64679-761_78294e7e-bc6c-497a-8e17-4b3d6c377b39 64679-761 HUMAN PRESCRIPTION DRUG PROMETHAZINE HCL promethazine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20091223 ANDA ANDA040785 Wockhardt USA LLC. PROMETHAZINE HYDROCHLORIDE 50 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 64679-762_a9f383ec-b87c-499f-9cc3-1fc6ee84f178 64679-762 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20080530 ANDA ANDA078141 Wockhardt USA LLC. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 64679-763_a9f383ec-b87c-499f-9cc3-1fc6ee84f178 64679-763 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20080530 ANDA ANDA078141 Wockhardt USA LLC. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 64679-764_209d926b-f1af-49e2-be94-53c7035b0b93 64679-764 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20081110 ANDA ANDA078511 Wockhardt USA LLC. MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 64679-765_209d926b-f1af-49e2-be94-53c7035b0b93 64679-765 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20081110 ANDA ANDA078511 Wockhardt USA LLC. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 64679-771_06f0187d-7cce-48f9-9797-dfe20ca39d23 64679-771 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64679-773_06f0187d-7cce-48f9-9797-dfe20ca39d23 64679-773 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64679-774_06f0187d-7cce-48f9-9797-dfe20ca39d23 64679-774 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64679-775_06f0187d-7cce-48f9-9797-dfe20ca39d23 64679-775 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 12 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64679-776_06f0187d-7cce-48f9-9797-dfe20ca39d23 64679-776 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120815 ANDA ANDA091395 Wockhardt USA LLC. ROPINIROLE HYDROCHLORIDE 6 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 64679-780_fde28f12-caca-45c3-9c2a-89334708cd94 64679-780 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride INJECTION INTRAVENOUS 20081030 ANDA ANDA077834 Wockhardt USA LLC. AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 64679-781_88d5791d-651f-4f8d-af5b-0945c94204eb 64679-781 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20120930 NDA NDA020796 Wockhardt USA LLC. ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 64679-782_94c80f6e-3e34-477f-b09d-05eeed137792 64679-782 HUMAN PRESCRIPTION DRUG CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt USA LLC. LEVODOPA; ENTACAPONE; CARBIDOPA 50; 200; 12.5 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 64679-783_94c80f6e-3e34-477f-b09d-05eeed137792 64679-783 HUMAN PRESCRIPTION DRUG CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt USA LLC. LEVODOPA; ENTACAPONE; CARBIDOPA 75; 200; 18.75 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 64679-784_94c80f6e-3e34-477f-b09d-05eeed137792 64679-784 HUMAN PRESCRIPTION DRUG CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt USA LLC. LEVODOPA; ENTACAPONE; CARBIDOPA 100; 200; 25 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 64679-785_94c80f6e-3e34-477f-b09d-05eeed137792 64679-785 HUMAN PRESCRIPTION DRUG CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt USA LLC. LEVODOPA; ENTACAPONE; CARBIDOPA 125; 200; 31.25 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 64679-786_94c80f6e-3e34-477f-b09d-05eeed137792 64679-786 HUMAN PRESCRIPTION DRUG CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt USA LLC. LEVODOPA; ENTACAPONE; CARBIDOPA 150; 200; 37.5 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 64679-787_94c80f6e-3e34-477f-b09d-05eeed137792 64679-787 HUMAN PRESCRIPTION DRUG CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa, levodopa and entacapone TABLET, FILM COATED ORAL 20120229 NDA AUTHORIZED GENERIC NDA021485 Wockhardt USA LLC. LEVODOPA; ENTACAPONE; CARBIDOPA 200; 200; 50 mg/1; mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient],Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 64679-810_5f296c99-aae6-4348-bdbd-b1fa3e2678d1 64679-810 HUMAN PRESCRIPTION DRUG Baycadron Dexamethasone ELIXIR ORAL 19830727 ANDA ANDA088254 Wockhardt USA, LLC DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 64679-902_720277aa-9eea-457a-8beb-4dcc5dd2b29a 64679-902 HUMAN PRESCRIPTION DRUG CAPTOPRIL captopril TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt USA LLC. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 64679-903_720277aa-9eea-457a-8beb-4dcc5dd2b29a 64679-903 HUMAN PRESCRIPTION DRUG CAPTOPRIL captopril TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt USA LLC. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 64679-904_720277aa-9eea-457a-8beb-4dcc5dd2b29a 64679-904 HUMAN PRESCRIPTION DRUG CAPTOPRIL captopril TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt USA LLC. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 64679-905_720277aa-9eea-457a-8beb-4dcc5dd2b29a 64679-905 HUMAN PRESCRIPTION DRUG CAPTOPRIL captopril TABLET ORAL 19970328 ANDA ANDA074532 Wockhardt USA LLC. CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 64679-906_beec2e66-ef09-41a2-bd3a-2e3ab6d81373 64679-906 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 19981217 ANDA ANDA075208 WOCKHARDT USA LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 64679-907_beec2e66-ef09-41a2-bd3a-2e3ab6d81373 64679-907 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE TABLET ORAL 19981217 ANDA ANDA075208 WOCKHARDT USA LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 64679-920_b66cf141-f1fb-4aa6-b2ba-7e5b4ac33dd7 64679-920 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Wockhardt USA LLC. CEFUROXIME AXETIL 125 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 64679-921_b66cf141-f1fb-4aa6-b2ba-7e5b4ac33dd7 64679-921 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Wockhardt USA LLC. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 64679-922_b66cf141-f1fb-4aa6-b2ba-7e5b4ac33dd7 64679-922 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20050729 ANDA ANDA065166 Wockhardt USA LLC. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 64679-923_2e45de69-fb5b-4f69-8c89-de6698123902 64679-923 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt USA LLC. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 64679-924_2e45de69-fb5b-4f69-8c89-de6698123902 64679-924 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt USA LLC. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 64679-925_2e45de69-fb5b-4f69-8c89-de6698123902 64679-925 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt USA LLC. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 64679-926_2e45de69-fb5b-4f69-8c89-de6698123902 64679-926 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Wockhardt USA LLC. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 64679-927_f63e0e9e-130e-4372-84e1-9cc9a90e151f 64679-927 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt USA LLC. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 64679-928_f63e0e9e-130e-4372-84e1-9cc9a90e151f 64679-928 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt USA LLC. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 64679-929_f63e0e9e-130e-4372-84e1-9cc9a90e151f 64679-929 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt USA LLC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 64679-936_c4b3566a-36a7-42bc-8a43-07923a5cb525 64679-936 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Wockhardt USA LLC. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 64679-937_c4b3566a-36a7-42bc-8a43-07923a5cb525 64679-937 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Wockhardt USA LLC. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 64679-941_f63e0e9e-130e-4372-84e1-9cc9a90e151f 64679-941 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt USA LLC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 64679-942_f63e0e9e-130e-4372-84e1-9cc9a90e151f 64679-942 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt USA LLC. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 64679-945_45429c50-70bd-4f75-8715-62ec39ee5192 64679-945 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060727 ANDA ANDA077636 Wockhardt USA LLC. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 64679-946_45429c50-70bd-4f75-8715-62ec39ee5192 64679-946 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20060727 ANDA ANDA077636 Wockhardt USA LLC. ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 64679-947_364594f3-248e-450c-b78e-322360c4a908 64679-947 HUMAN PRESCRIPTION DRUG Cefotaxime Cefotaxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080620 ANDA ANDA065197 Wockhardt USA LLC. CEFOTAXIME SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 64679-948_364594f3-248e-450c-b78e-322360c4a908 64679-948 HUMAN PRESCRIPTION DRUG Cefotaxime Cefotaxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080620 ANDA ANDA065197 Wockhardt USA LLC. CEFOTAXIME SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 64679-949_be31a01a-14ff-4eb9-ab01-0b572f47ef08 64679-949 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Wockhardt USA LLC. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 64679-953_f63e0e9e-130e-4372-84e1-9cc9a90e151f 64679-953 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20070419 ANDA ANDA078402 Wockhardt USA LLC. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 64679-954_be31a01a-14ff-4eb9-ab01-0b572f47ef08 64679-954 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20060531 ANDA ANDA065266 Wockhardt USA LLC. CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 64679-961_26c57fba-1182-408a-93a0-a45ea95ac210 64679-961 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Wockhardt USA LLC. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 64679-962_32e196dc-e4fc-4948-baee-0f014e366bce 64679-962 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065302 Wockhardt USA LLC. AZITHROMYCIN ANHYDROUS 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 64679-964_26c57fba-1182-408a-93a0-a45ea95ac210 64679-964 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 Wockhardt USA LLC. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 64679-965_dbffb280-464a-47f2-8a85-5191e520e078 64679-965 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride 5 mg TABLET ORAL 20030929 ANDA ANDA040532 Wockhardt USA LLC. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 64679-966_dbffb280-464a-47f2-8a85-5191e520e078 64679-966 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride 10 mg TABLET ORAL 20030929 ANDA ANDA040533 Wockhardt USA LLC. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 64679-967_dbffb280-464a-47f2-8a85-5191e520e078 64679-967 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride 25 mg TABLET ORAL 20030929 ANDA ANDA040534 Wockhardt USA LLC. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 64679-968_dbffb280-464a-47f2-8a85-5191e520e078 64679-968 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride 50 mg TABLET ORAL 20030929 ANDA ANDA040518 Wockhardt USA LLC. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 64679-972_c50c4e64-8314-4452-a5b8-e000185487eb 64679-972 HUMAN OTC DRUG FAMOTIDINE FAMOTIDINE TABLET ORAL 20050307 ANDA ANDA077146 WOCKHARDT USA LLC. FAMOTIDINE 10 mg/1 N 20181231 64679-973_ea12d073-1a48-49a7-9080-19711d50dbbe 64679-973 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20080731 ANDA ANDA077296 Wockhardt USA LLC. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 64679-974_ea12d073-1a48-49a7-9080-19711d50dbbe 64679-974 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20080731 ANDA ANDA077296 Wockhardt USA LLC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 64679-975_ea12d073-1a48-49a7-9080-19711d50dbbe 64679-975 HUMAN PRESCRIPTION DRUG DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE ORAL 20080731 ANDA ANDA077296 Wockhardt USA LLC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 64679-976_4d31a613-a1a4-438c-ba28-950cf0a6163f 64679-976 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA078038 Wockhardt USA LLC. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 64679-977_4d31a613-a1a4-438c-ba28-950cf0a6163f 64679-977 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA078038 Wockhardt USA LLC. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 64679-978_4d31a613-a1a4-438c-ba28-950cf0a6163f 64679-978 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130213 ANDA ANDA078038 Wockhardt USA LLC. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 64679-982_e8a55782-2ebf-4821-a954-928815fd80e9 64679-982 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt USA LLC. FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 64679-982_fb544146-d163-43a2-9314-0b28cfbfd388 64679-982 HUMAN OTC DRUG ALLERGY 24-HR FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt USA LLC. FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 64679-983_e448a92e-1aea-4691-a69c-bee4fa6e3850 64679-983 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060512 ANDA ANDA065180 Wockhardt USA LLC. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 64679-986_364594f3-248e-450c-b78e-322360c4a908 64679-986 HUMAN PRESCRIPTION DRUG Cefotaxime Cefotaxime INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080829 ANDA ANDA065197 Wockhardt USA LLC. CEFOTAXIME SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 64679-987_e8a55782-2ebf-4821-a954-928815fd80e9 64679-987 HUMAN OTC DRUG Fexofenadine Fexofenadine TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt USA LLC. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 64679-987_fb544146-d163-43a2-9314-0b28cfbfd388 64679-987 HUMAN OTC DRUG ALLERGY 24-HR FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120208 ANDA ANDA079112 Wockhardt USA LLC. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 64679-990_45429c50-70bd-4f75-8715-62ec39ee5192 64679-990 HUMAN PRESCRIPTION DRUG ZONISAMIDE ZONISAMIDE CAPSULE ORAL 20051222 ANDA ANDA077636 Wockhardt USA LLC. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 64679-991_a4b14e6f-e4f9-4716-a92b-35bcbaacb4f6 64679-991 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt USA LLC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 64679-992_a4b14e6f-e4f9-4716-a92b-35bcbaacb4f6 64679-992 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt USA LLC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 64679-993_a4b14e6f-e4f9-4716-a92b-35bcbaacb4f6 64679-993 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt USA LLC. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 64679-994_a4b14e6f-e4f9-4716-a92b-35bcbaacb4f6 64679-994 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 Wockhardt USA LLC. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 64680-0001_738dad7d-8d76-4574-b33c-6ef4a9287edb 64680-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990101 UNAPPROVED MEDICAL GAS HomeReach OXYGEN 99 L/100L E 20171231 64693-002_e2e37ae9-824f-47a2-8638-3b627db10d3e 64693-002 HUMAN PRESCRIPTION DRUG INOmax nitric oxide GAS RESPIRATORY (INHALATION) 19991223 NDA NDA020845 INO Therapeutics NITRIC OXIDE .98 mg/L Vasodilation [PE],Vasodilator [EPC] N 20181231 64696-1968_9d56bb06-cc9d-420f-878f-b9fc87028136 64696-1968 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20071128 UNAPPROVED MEDICAL GAS Ambercare Medical Supply Co. OXYGEN 99 L/100L E 20171231 64712-001_4e0a66f2-de72-41e6-8cdd-2ab7a7d1def7 64712-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Health Complex Medical Inc OXYGEN 99 L/100L E 20171231 64717-0513_4d5377c5-7238-4d16-819d-99e77c9b23bf 64717-0513 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19980901 UNAPPROVED MEDICAL GAS JTW Inc. DBA Milburn Pharmacy OXYGEN 99 L/100L E 20171231 64720-126_1659f993-61b9-40e6-af7a-36cfd47978aa 64720-126 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20160526 ANDA ANDA040486 CorePharma, LLC METAXALONE 400 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 64720-130_a616d895-9a2e-4efd-b5ae-f649d68cbdcb 64720-130 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20070509 20191031 ANDA ANDA040444 CorePharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 64720-131_a616d895-9a2e-4efd-b5ae-f649d68cbdcb 64720-131 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20141107 20180228 ANDA ANDA040444 CorePharma, LLC AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 64720-132_a616d895-9a2e-4efd-b5ae-f649d68cbdcb 64720-132 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20070509 20191231 ANDA ANDA040444 CorePharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 64720-133_a616d895-9a2e-4efd-b5ae-f649d68cbdcb 64720-133 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20141107 20180228 ANDA ANDA040444 CorePharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 64720-134_a616d895-9a2e-4efd-b5ae-f649d68cbdcb 64720-134 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20141107 20181031 ANDA ANDA040444 CorePharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 64720-135_a616d895-9a2e-4efd-b5ae-f649d68cbdcb 64720-135 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20070509 20200131 ANDA ANDA040444 CorePharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 64720-136_a616d895-9a2e-4efd-b5ae-f649d68cbdcb 64720-136 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20070509 20191231 ANDA ANDA040444 CorePharma, LLC DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 64720-139_47555e90-ebe6-4421-a184-b0e2f2f31bab 64720-139 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20030701 ANDA ANDA076411 CorePharma, LLC METHENAMINE HIPPURATE 1 g/1 N 20181231 64720-150_c20f2cc0-9760-44ba-ac9e-1dbc2b2f9f05 64720-150 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20150729 20200131 ANDA ANDA040537 CorePharma, LLC CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 64720-224_d4220d55-0bfb-4ddb-a380-0ff22cfdd226 64720-224 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20091027 20190131 ANDA ANDA090895 CorePharma, LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 64720-225_d4220d55-0bfb-4ddb-a380-0ff22cfdd226 64720-225 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20091027 20190131 ANDA ANDA090895 CorePharma, LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 64720-226_d4220d55-0bfb-4ddb-a380-0ff22cfdd226 64720-226 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20091027 20190228 ANDA ANDA090895 CorePharma, LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 64720-229_587a6dc3-88ad-465e-9141-52ce5a9c1df8 64720-229 HUMAN PRESCRIPTION DRUG Molindone Hydrochloride Molindone Hydrochloride TABLET ORAL 20150915 20180228 ANDA ANDA090453 CorePharma, LLC MOLINDONE HYDROCHLORIDE 10 mg/1 Typical Antipsychotic [EPC] N 20181231 64720-230_587a6dc3-88ad-465e-9141-52ce5a9c1df8 64720-230 HUMAN PRESCRIPTION DRUG Molindone Hydrochloride Molindone Hydrochloride TABLET ORAL 20150915 20180331 ANDA ANDA090453 CorePharma, LLC MOLINDONE HYDROCHLORIDE 25 mg/1 Typical Antipsychotic [EPC] N 20181231 64720-237_d793d177-597c-4de3-a811-7d26b2ebceeb 64720-237 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20140407 ANDA ANDA091159 CorePharma, LLC METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 64720-238_d793d177-597c-4de3-a811-7d26b2ebceeb 64720-238 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20140407 ANDA ANDA091159 CorePharma, LLC METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 64720-239_d793d177-597c-4de3-a811-7d26b2ebceeb 64720-239 HUMAN PRESCRIPTION DRUG METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE TABLET ORAL 20140407 ANDA ANDA091159 CorePharma, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 64720-255_840f692c-8a05-4079-9349-5af934986629 64720-255 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20170306 ANDA ANDA202284 CorePharma, LLC FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 64720-256_840f692c-8a05-4079-9349-5af934986629 64720-256 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20170306 ANDA ANDA202284 CorePharma, LLC FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 64720-290_05ea5d0f-ba3a-4380-83b8-416abd02cd09 64720-290 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20160601 ANDA ANDA206079 CorePharma, LLC GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 64720-291_05ea5d0f-ba3a-4380-83b8-416abd02cd09 64720-291 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20160601 ANDA ANDA206079 CorePharma, LLC GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 64720-292_05ea5d0f-ba3a-4380-83b8-416abd02cd09 64720-292 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20160601 ANDA ANDA206079 CorePharma, LLC GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 64720-295_bcdf760a-bfce-4071-8116-99e1473226df 64720-295 HUMAN PRESCRIPTION DRUG Ultramicrosize Griseofulvin Ultramicrosize Griseofulvin Tablets TABLET, COATED ORAL 20140929 20190731 ANDA ANDA204371 CorePharma, LLC GRISEOFULVIN 125 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 64720-296_bcdf760a-bfce-4071-8116-99e1473226df 64720-296 HUMAN PRESCRIPTION DRUG Ultramicrosize Griseofulvin Ultramicrosize Griseofulvin Tablets TABLET, COATED ORAL 20140929 20190731 ANDA ANDA204371 CorePharma, LLC GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 64720-321_d1a9d1e9-298d-4cf1-a5a3-80c1d0d78fab 64720-321 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 CorePharma, LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 64720-336_0f0fd5e2-abb0-4044-a7f9-b3250a342571 64720-336 HUMAN PRESCRIPTION DRUG Quinine Sulfate Quinine Sulfate CAPSULE ORAL 20150723 ANDA ANDA204372 CorePharma, LLC QUININE SULFATE 324 mg/1 Antimalarial [EPC] N 20181231 64720-401_27cce73d-4016-40ae-882f-80c35344ecc0 64720-401 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160920 ANDA ANDA205105 CorePharma, LLC METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 64720-402_27cce73d-4016-40ae-882f-80c35344ecc0 64720-402 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160920 ANDA ANDA205105 CorePharma, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 64720-403_27cce73d-4016-40ae-882f-80c35344ecc0 64720-403 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160920 ANDA ANDA205105 CorePharma, LLC METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 64720-404_27cce73d-4016-40ae-882f-80c35344ecc0 64720-404 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160920 ANDA ANDA205105 CorePharma, LLC METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 64720-405_27cce73d-4016-40ae-882f-80c35344ecc0 64720-405 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160920 ANDA ANDA205105 CorePharma, LLC METHYLPHENIDATE HYDROCHLORIDE 50 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 64720-406_27cce73d-4016-40ae-882f-80c35344ecc0 64720-406 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160920 ANDA ANDA205105 CorePharma, LLC METHYLPHENIDATE HYDROCHLORIDE 60 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 64720-415_338d4dda-3eab-4027-b59c-7f556605cda8 64720-415 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20170714 ANDA ANDA205153 CorePharma, LLC DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 64720-416_338d4dda-3eab-4027-b59c-7f556605cda8 64720-416 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride desipramine hydrochloride TABLET, FILM COATED ORAL 20170714 ANDA ANDA205153 CorePharma, LLC DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 64720-417_338d4dda-3eab-4027-b59c-7f556605cda8 64720-417 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20170714 ANDA ANDA205153 CorePharma, LLC DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 64720-418_338d4dda-3eab-4027-b59c-7f556605cda8 64720-418 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20170714 ANDA ANDA205153 CorePharma, LLC DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 64720-419_338d4dda-3eab-4027-b59c-7f556605cda8 64720-419 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20170714 ANDA ANDA205153 CorePharma, LLC DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 64720-420_338d4dda-3eab-4027-b59c-7f556605cda8 64720-420 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20170714 ANDA ANDA205153 CorePharma, LLC DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 64724-1016_cbf8a6f3-299a-472b-a7dd-45034bba72b3 64724-1016 HUMAN OTC DRUG NATURALTECH PURIFYING ANTI-DANDRUFF SELENIUM SULFIDE SHAMPOO TOPICAL 20120229 OTC MONOGRAPH FINAL part358H Davines S.p.A. SELENIUM SULFIDE .6 g/100mL N 20181231 64724-1017_5f229787-b598-41bc-98c9-1159e97defc7 64724-1017 HUMAN OTC DRUG NATURALTECH PURIFYING ANTI-DANDRUFF PYRITHIONE ZINC GEL TOPICAL 20120229 OTC MONOGRAPH FINAL part358H Davines S.p.A. PYRITHIONE ZINC .48 g/100mL N 20181231 64725-0003_11c6fa42-464d-4468-99b6-d6c6eadd7f2c 64725-0003 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 TYA Pharmaceuticals MIRTAZAPINE 30 mg/1 E 20171231 64725-0004_ef3921b4-9f0f-4338-a7ce-38e3450a1230 64725-0004 HUMAN OTC DRUG MI-ACID REGULAR STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 TYA Pharmaceuticals ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL E 20171231 64725-0006_86ddf799-88d3-4d05-ae29-34e13a89cd22 64725-0006 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 TYA Pharmaceuticals ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0007_86ddf799-88d3-4d05-ae29-34e13a89cd22 64725-0007 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 TYA Pharmaceuticals ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0008_fd282b6a-5788-48e6-bea4-dc2998a492df 64725-0008 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 TYA Pharmaceuticals ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 64725-0009_1c1e7873-4fbf-4033-94d7-9fd8416b828e 64725-0009 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 TYA Pharmaceuticals ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0010_58dcf6a8-3134-406d-9999-43f7212834df 64725-0010 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 TYA Pharmaceuticals CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0012_9573c6b0-a783-4559-8e44-74ee89fc28a2 64725-0012 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20120808 NDA AUTHORIZED GENERIC NDA012015 TYA Pharmaceuticals BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 64725-0017_1ff9ff68-ac5f-4b77-b62a-7ca1b0919176 64725-0017 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 TYA Pharmaceuticals AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 64725-0026_e1bd9725-c029-44d5-bace-c9e3f1ae2d0d 64725-0026 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 TYA Pharmaceuticals HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 64725-0034_a725cf7e-3cda-484d-acaf-28f3ace2dcbc 64725-0034 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 TYA Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0036_a725cf7e-3cda-484d-acaf-28f3ace2dcbc 64725-0036 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 TYA Pharmaceuticals VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0041_364f49ee-04a1-4130-b4f6-93ae21a9c3c7 64725-0041 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 TYA Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 64725-0045_fefc0b73-ba82-4ff3-b3ac-75860885cb45 64725-0045 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20101210 ANDA ANDA079237 TYA Pharmaceuticals HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 64725-0047_c2dad462-8302-427f-91e3-e1c08a9b2a34 64725-0047 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100820 ANDA ANDA040807 TYA Pharmaceuticals HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 64725-0056_464e51ff-2b84-44b4-82e4-34b4f19e677f 64725-0056 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 TYA Pharmaceuticals WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 64725-0058_1aef037e-5758-415a-ae16-a32d6b1d5fe7 64725-0058 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 TYA Pharmaceuticals GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 64725-0080_2e6f2b3e-1cc5-4121-8354-a169da971973 64725-0080 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 TYA Pharmaceuticals HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] E 20171231 64725-0083_f22e1d97-8bc3-4879-a177-e76481ec4ffc 64725-0083 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 TYA Pharmaceuticals PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0097_f22e1d97-8bc3-4879-a177-e76481ec4ffc 64725-0097 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20030908 ANDA ANDA075356 TYA Pharmaceuticals PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0098_ec6427fb-04a8-4478-9f9c-88d08ed2a66a 64725-0098 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 TYA Pharmaceuticals PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0101_3d443c42-3db1-4cd0-a5f6-9fdd47f19869 64725-0101 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 TYA Pharmaceuticals CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 64725-0102_ade7f111-e31f-44db-8f9c-3cb479fafad8 64725-0102 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 TYA Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 64725-0104_c3418329-3ad4-4cdc-8662-ed38c62b64b0 64725-0104 HUMAN PRESCRIPTION DRUG Aplisol Tuberculin Purified Protein Derivative INJECTION INTRADERMAL 20140425 BLA BLA103782 TYA Pharmaceuticals TUBERCULIN PURIFIED PROTEIN DERIVATIVE 5 [iU]/.1mL Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [Chemical/Ingredient] E 20171231 64725-0110_8cac22bb-9205-4c92-a5ae-912ac62e632a 64725-0110 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 TYA Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 64725-0111_858f7e7f-5d6b-46dc-a1df-4e3e7229ea24 64725-0111 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 TYA Pharmaceuticals LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 64725-0112_858f7e7f-5d6b-46dc-a1df-4e3e7229ea24 64725-0112 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111101 ANDA ANDA090170 TYA Pharmaceuticals LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 64725-0113_271f3da1-d81a-4938-94bd-84486e946655 64725-0113 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 TYA Pharmaceuticals RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0114_271f3da1-d81a-4938-94bd-84486e946655 64725-0114 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 TYA Pharmaceuticals RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0121_73e3c0cc-32d7-46ff-b7a5-693bd3b78a46 64725-0121 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 TYA Pharmaceuticals CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 64725-0126_7a56733c-238a-4b87-b713-39220882bd53 64725-0126 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 TYA Pharmaceuticals GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 64725-0136_c8b952cf-9bd9-4b1d-9739-b38afca10e02 64725-0136 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20101124 ANDA ANDA077147 TYA Pharmaceuticals CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-0137_b3b282db-b87e-456f-9c71-3f13d2e1ddb9 64725-0137 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 TYA Pharmaceuticals OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 64725-0138_dbba4900-cfca-4dd9-8241-b8a675ab6128 64725-0138 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20060824 ANDA ANDA077242 TYA Pharmaceuticals GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 64725-0139_5c19918f-203d-46cb-b7ac-f4d81a6f9a90 64725-0139 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110301 ANDA ANDA074550 TYA Pharmaceuticals GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 64725-0145_6101afa7-97c1-4445-ae8a-1bca25f03333 64725-0145 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 TYA Pharmaceuticals QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0146_05026ebb-617d-47ff-ac20-51d2c14a528d 64725-0146 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19860825 ANDA ANDA071017 TYA Pharmaceuticals SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 64725-0147_1c75b165-9530-4892-a732-ca5fac322235 64725-0147 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 TYA Pharmaceuticals QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0148_6101afa7-97c1-4445-ae8a-1bca25f03333 64725-0148 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 TYA Pharmaceuticals QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0149_eb4a24e1-aceb-4643-ac40-45649dcd0a6a 64725-0149 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120326 ANDA ANDA202152 TYA Pharmaceuticals QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0158_bdead3a9-9287-4c36-b38b-c53a2bb35fa3 64725-0158 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 TYA Pharmaceuticals OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 64725-0159_6689dca3-528e-4013-89d5-b42fcca486d7 64725-0159 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760702 ANDA ANDA084769 TYA Pharmaceuticals CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-0161_e64758bf-e522-4c96-b9ac-c920a200e210 64725-0161 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20101117 ANDA ANDA091630 TYA Pharmaceuticals TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 E 20171231 64725-0169_290c9184-8e8a-4512-bc7e-20af6d596c85 64725-0169 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 TYA Pharmaceuticals HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 64725-0170_290c9184-8e8a-4512-bc7e-20af6d596c85 64725-0170 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 TYA Pharmaceuticals HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 64725-0192_e99df3bf-a3bd-4d37-9632-acefe2359e50 64725-0192 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 TYA Pharmaceuticals FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0193_e99df3bf-a3bd-4d37-9632-acefe2359e50 64725-0193 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 TYA Pharmaceuticals FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0197_1c0a7105-b561-472a-aa52-5593386181f6 64725-0197 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 TYA Pharmaceuticals PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0209_8ec7115c-b3e2-428b-9bb8-8e6516054381 64725-0209 HUMAN OTC DRUG Siltussin DM Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 19920905 OTC MONOGRAPH FINAL part341 TYA Pharmaceuticals GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL E 20171231 64725-0212_b764f252-3d81-4947-ba41-89c29326f484 64725-0212 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 TYA Pharmaceuticals SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0213_b764f252-3d81-4947-ba41-89c29326f484 64725-0213 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 TYA Pharmaceuticals SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0214_f3a5ed5a-a76e-4b7a-91a8-5d5e0c3d33b8 64725-0214 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 TYA Pharmaceuticals HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] E 20171231 64725-0215_2dfe29d8-d1da-4ee7-be45-e87c779d3d7c 64725-0215 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 TYA Pharmaceuticals CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 64725-0221_dba983ee-133b-45c2-b552-c5e999b48980 64725-0221 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 TYA Pharmaceuticals GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 64725-0222_dba983ee-133b-45c2-b552-c5e999b48980 64725-0222 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 TYA Pharmaceuticals GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 64725-0238_09bd05f2-2c3f-47b0-9b25-9da517dec583 64725-0238 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 TYA Pharmaceuticals AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 64725-0242_aed23cc5-a21d-4d2c-8a9d-df1657d594ab 64725-0242 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072928 TYA Pharmaceuticals LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-0247_b7a6199a-9010-4f2d-8887-f701d6e7068b 64725-0247 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 TYA Pharmaceuticals MIRTAZAPINE 15 mg/1 E 20171231 64725-0250_2a6665b4-9ccd-4778-913a-e7d805250d0c 64725-0250 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 TYA Pharmaceuticals ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0251_2a6665b4-9ccd-4778-913a-e7d805250d0c 64725-0251 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 ANDA ANDA078604 TYA Pharmaceuticals ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0259_d91c0167-00cf-44e5-8d0f-0629b5241bfa 64725-0259 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077565 TYA Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0265_ecec32e8-eb3f-4c1c-87cd-d459f59ed6fb 64725-0265 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20111024 ANDA ANDA076534 TYA Pharmaceuticals OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0272_e162b234-b57c-4326-b661-0f5c3c4d3e08 64725-0272 HUMAN PRESCRIPTION DRUG Fluphenazine Decanoate FLUPHENAZINE DECANOATE INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20101215 ANDA ANDA071413 TYA Pharmaceuticals FLUPHENAZINE DECANOATE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 64725-0280_09f9c7b9-7622-4089-b6b9-8e5be366a398 64725-0280 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20090201 NDA NDA022047 TYA Pharmaceuticals QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0281_09f9c7b9-7622-4089-b6b9-8e5be366a398 64725-0281 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20090201 NDA NDA022047 TYA Pharmaceuticals QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0282_09f9c7b9-7622-4089-b6b9-8e5be366a398 64725-0282 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20070716 NDA NDA022047 TYA Pharmaceuticals QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0283_09f9c7b9-7622-4089-b6b9-8e5be366a398 64725-0283 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20070716 NDA NDA022047 TYA Pharmaceuticals QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0284_09f9c7b9-7622-4089-b6b9-8e5be366a398 64725-0284 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20070716 NDA NDA022047 TYA Pharmaceuticals QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0292_885b029e-8ee6-4aa6-acf9-338058069e3d 64725-0292 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 TYA Pharmaceuticals OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 64725-0302_11445e6b-4efa-40db-909c-5c6ad3d056cb 64725-0302 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19840701 ANDA ANDA088487 TYA Pharmaceuticals HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 64725-0304_39bbc251-0443-466d-b10e-7503e844e056 64725-0304 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084115 TYA Pharmaceuticals CHLORPROMAZINE HYDROCHLORIDE 200 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 64725-0314_af3febff-f6b0-4bb3-9f83-142ef96135e9 64725-0314 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20000804 NDA AUTHORIZED GENERIC NDA021168 TYA Pharmaceuticals DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 64725-0315_af3febff-f6b0-4bb3-9f83-142ef96135e9 64725-0315 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021168 TYA Pharmaceuticals DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 64725-0319_ee72430a-f6cd-4cbc-a312-102c266bf965 64725-0319 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20120425 ANDA ANDA201003 TYA Pharmaceuticals RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0321_ee72430a-f6cd-4cbc-a312-102c266bf965 64725-0321 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20120425 ANDA ANDA201003 TYA Pharmaceuticals RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0323_11445e6b-4efa-40db-909c-5c6ad3d056cb 64725-0323 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19840701 ANDA ANDA088496 TYA Pharmaceuticals HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 64725-0327_f3a5ed5a-a76e-4b7a-91a8-5d5e0c3d33b8 64725-0327 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 19860610 ANDA ANDA070278 TYA Pharmaceuticals HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] E 20171231 64725-0351_3d8002ca-2951-4a47-a101-754ceed78309 64725-0351 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 TYA Pharmaceuticals SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0361_5cea160b-a566-4b0d-8a9e-1c7b532e9c61 64725-0361 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 TYA Pharmaceuticals FOLIC ACID 1 mg/1 E 20171231 64725-0376_ee7a0577-37b2-4747-b7c4-64cb7e74000e 64725-0376 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19721127 ANDA ANDA080817 TYA Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 64725-0397_45704b63-7b42-4685-882a-7d2559eda79f 64725-0397 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 TYA Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 64725-0401_f078b2e9-e6d3-41aa-b48c-7c65f4ea9f30 64725-0401 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 TYA Pharmaceuticals DOCUSATE SODIUM 100 mg/1 E 20171231 64725-0433_fa2555fb-073a-4244-9c01-fc285b5b171e 64725-0433 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 TYA Pharmaceuticals TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 64725-0434_476c6f63-97d9-4142-b778-58d72af4ab38 64725-0434 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 TYA Pharmaceuticals TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 64725-0465_0bee8638-785e-4a54-bb8d-bad1a972c82c 64725-0465 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 TYA Pharmaceuticals IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 64725-0471_b948d2eb-c7fa-49f2-bd68-18482f85dc72 64725-0471 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate HALOPERIDOL DECANOATE INJECTION INTRAMUSCULAR 20000712 ANDA ANDA074893 TYA Pharmaceuticals HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] E 20171231 64725-0477_ff4f2a34-1129-42d8-85da-e77666063693 64725-0477 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 TYA Pharmaceuticals METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 64725-0490_cf020deb-1ded-413c-912d-299443a61f6f 64725-0490 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140411 ANDA ANDA074661 TYA Pharmaceuticals NAPROXEN SODIUM 220 mg/1 E 20171231 64725-0500_9fa83fd2-deeb-4996-8771-19f12e7ac629 64725-0500 HUMAN PRESCRIPTION DRUG EPIPEN epinephrine INJECTION INTRAMUSCULAR 19871222 NDA NDA019430 TYA Pharmaceuticals EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 64725-0501_9fa83fd2-deeb-4996-8771-19f12e7ac629 64725-0501 HUMAN PRESCRIPTION DRUG EPIPEN JR epinephrine INJECTION INTRAMUSCULAR 19871222 NDA NDA019430 TYA Pharmaceuticals EPINEPHRINE .15 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 64725-0507_3dabf6fb-1c36-4841-b8af-61a0690c7f90 64725-0507 HUMAN PRESCRIPTION DRUG citalopram hydrobromide citalopram hydrobromide TABLET ORAL 20041112 ANDA ANDA077032 TYA Pharmaceuticals CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0511_e1cd96a9-6dfc-455a-9624-ba92e9c85c1e 64725-0511 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 TYA Pharmaceuticals GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 64725-0513_6d3d53d5-10d9-46a7-a251-f1eb1a2ffeeb 64725-0513 HUMAN PRESCRIPTION DRUG Intuniv guanfacine TABLET, EXTENDED RELEASE ORAL 20090902 NDA NDA022037 TYA Pharmaceuticals GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 64725-0514_5d172892-ed60-4914-934b-74c9771a2d5b 64725-0514 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 TYA Pharmaceuticals LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 64725-0515_6d3d53d5-10d9-46a7-a251-f1eb1a2ffeeb 64725-0515 HUMAN PRESCRIPTION DRUG Intuniv guanfacine TABLET, EXTENDED RELEASE ORAL 20090902 NDA NDA022037 TYA Pharmaceuticals GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 64725-0526_97284b19-ca6f-4ec0-adbc-b0720cec7e49 64725-0526 HUMAN OTC DRUG Loratadine Allergy Relief Loratadine TABLET ORAL 20030828 ANDA ANDA076134 TYA Pharmaceuticals LORATADINE 10 mg/1 E 20171231 64725-0544_16ffae65-14fe-4f4b-9214-0030b07d7ecf 64725-0544 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 TYA Pharmaceuticals LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] E 20171231 64725-0545_16ffae65-14fe-4f4b-9214-0030b07d7ecf 64725-0545 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 TYA Pharmaceuticals LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 64725-0550_67e10f52-3747-4542-bb6e-1afccd2df3fc 64725-0550 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20061219 NDA NDA021999 TYA Pharmaceuticals PALIPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0552_c7d79e6a-46cb-4ba7-bcb4-510604307cd1 64725-0552 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA091038 TYA Pharmaceuticals OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0554_c7d79e6a-46cb-4ba7-bcb4-510604307cd1 64725-0554 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA091038 TYA Pharmaceuticals OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0555_c7d79e6a-46cb-4ba7-bcb4-510604307cd1 64725-0555 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA091038 TYA Pharmaceuticals OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0579_119c2f38-9836-4cec-b6d5-990be9f47818 64725-0579 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090324 ANDA ANDA078459 TYA Pharmaceuticals METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 64725-0586_67e197bb-1535-4f76-9672-ba62f836735b 64725-0586 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 TYA Pharmaceuticals DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 64725-0595_c99e62c9-59d6-4461-a36d-ec6127d3954d 64725-0595 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140602 ANDA ANDA202419 TYA Pharmaceuticals DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 64725-0600_cc2bbbc5-dd33-4821-a97a-cc7452815998 64725-0600 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110222 NDA AUTHORIZED GENERIC NDA018279 TYA Pharmaceuticals POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 64725-0604_687b4bc7-0ea2-4602-a75c-5402739f1732 64725-0604 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20100618 ANDA ANDA090082 TYA Pharmaceuticals ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-0621_45ecdad5-5b7b-4eb4-b8b0-f89d02ad60e5 64725-0621 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 TYA Pharmaceuticals ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 64725-0624_031a2a0f-f357-45ed-9719-67ed4c7bca8f 64725-0624 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 TYA Pharmaceuticals FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 64725-0625_031a2a0f-f357-45ed-9719-67ed4c7bca8f 64725-0625 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 TYA Pharmaceuticals FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 64725-0649_0b22d1e4-6b18-48b1-890e-9d2c147f0acc 64725-0649 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 TYA Pharmaceuticals MAGNESIUM HYDROXIDE 1200 mg/15mL E 20171231 64725-0657_516341c3-df40-4da4-ad5b-9f54427589bf 64725-0657 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 TYA Pharmaceuticals BUSPIRONE HYDROCHLORIDE 5 mg/1 E 20171231 64725-0658_516341c3-df40-4da4-ad5b-9f54427589bf 64725-0658 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 TYA Pharmaceuticals BUSPIRONE HYDROCHLORIDE 10 mg/1 E 20171231 64725-0691_c8f056bb-0ec7-49bb-96c5-723dd5d93a41 64725-0691 HUMAN OTC DRUG Sunmark Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050623 ANDA ANDA078325 TYA Pharmaceuticals NICOTINE 2 mg/1 E 20171231 64725-0707_494c452e-d8fc-482e-9eb4-64c7a92c14ce 64725-0707 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 TYA Pharmaceuticals TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 64725-0710_494c452e-d8fc-482e-9eb4-64c7a92c14ce 64725-0710 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 TYA Pharmaceuticals TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 64725-0711_f4bba57b-92f5-4850-b329-36ee214dc013 64725-0711 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 19981125 ANDA ANDA075109 TYA Pharmaceuticals GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 64725-0716_b2310339-e7c0-4deb-9899-ba0a692891bb 64725-0716 HUMAN OTC DRUG Plus Pharma NSAID 325 mg ASPIRIN TABLET ORAL 20140929 OTC MONOGRAPH FINAL part343 TYA Pharmaceuticals ASPIRIN 81 mg/1 E 20171231 64725-0720_ec4681c5-a369-4557-af26-fc5695772023 64725-0720 HUMAN PRESCRIPTION DRUG EXTENDED PHENYTOIN SODIUM EXTENDED PHENYTOIN SODIUM CAPSULE ORAL 20080130 ANDA ANDA040732 TYA Pharmaceuticals PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 64725-0736_a48f17ec-bca5-486d-a68e-aceaa66d57c6 64725-0736 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 TYA Pharmaceuticals BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 64725-0737_a48f17ec-bca5-486d-a68e-aceaa66d57c6 64725-0737 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 TYA Pharmaceuticals BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 64725-0747_d086a93f-bee2-4ef5-859c-d593485aa83c 64725-0747 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 TYA Pharmaceuticals DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-0750_f92b7a9d-49f8-4b5e-9598-7d2c606ff62f 64725-0750 HUMAN PRESCRIPTION DRUG NovoLog insulin aspart INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20010827 NDA NDA020986 TYA Pharmaceuticals INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 64725-0751_0c423960-d654-405a-9c7e-75786213899f 64725-0751 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120228 ANDA ANDA090881 TYA Pharmaceuticals OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0757_0c423960-d654-405a-9c7e-75786213899f 64725-0757 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20120228 ANDA ANDA090881 TYA Pharmaceuticals OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0772_0af9a6fe-84a2-4f34-b0ff-76646d52e917 64725-0772 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 TYA Pharmaceuticals LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-0773_0af9a6fe-84a2-4f34-b0ff-76646d52e917 64725-0773 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20011211 ANDA ANDA076045 TYA Pharmaceuticals LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-0797_e209f276-8e72-43a3-94e5-aef94ac76054 64725-0797 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 TYA Pharmaceuticals DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 64725-0798_e209f276-8e72-43a3-94e5-aef94ac76054 64725-0798 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 TYA Pharmaceuticals DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 64725-0800_2d448e1b-79d2-4342-83ec-ed95113d6611 64725-0800 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960715 ANDA ANDA040156 TYA Pharmaceuticals HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 64725-0801_2d448e1b-79d2-4342-83ec-ed95113d6611 64725-0801 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 19960615 ANDA ANDA040156 TYA Pharmaceuticals HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 64725-0833_42473c39-b5b9-429c-a21f-8c63cbb65310 64725-0833 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19970725 ANDA ANDA040145 TYA Pharmaceuticals WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] E 20171231 64725-0911_9306182b-23de-4c41-b811-f1375e91d966 64725-0911 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol INJECTION INTRAMUSCULAR 20110617 NDA AUTHORIZED GENERIC NDA015923 TYA Pharmaceuticals HALOPERIDOL 5 mg/mL Typical Antipsychotic [EPC] E 20171231 64725-0924_590283db-1dad-42e4-9ce8-077be2f99ca1 64725-0924 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 TYA Pharmaceuticals ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 64725-0930_53bd79f1-87dc-450b-bfc2-c75fe35569c7 64725-0930 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 TYA Pharmaceuticals BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII E 20171231 64725-0955_e66eb52e-210e-49f2-910d-38ac51616e63 64725-0955 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20120627 ANDA ANDA201741 TYA Pharmaceuticals OLANZAPINE 10 mg/2mL Atypical Antipsychotic [EPC] E 20171231 64725-0981_1fcb1187-31a2-413d-9edd-85bcd07aacec 64725-0981 HUMAN OTC DRUG Adult Low Dose Enteric Coated Aspirin Aspirin TABLET, COATED ORAL 20000701 OTC MONOGRAPH FINAL part343 TYA Pharmaceuticals ASPIRIN 81 mg/1 E 20171231 64725-0993_3661200b-ba45-45c7-b29b-714b1fe94955 64725-0993 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 TYA Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-0994_3661200b-ba45-45c7-b29b-714b1fe94955 64725-0994 HUMAN PRESCRIPTION DRUG Ziprasidone hydrochloride Ziprasidone hydrochloride CAPSULE ORAL 20120901 ANDA ANDA090348 TYA Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-1020_b33bdf2c-8947-4d30-b72f-1364a018446c 64725-1020 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 TYA Pharmaceuticals LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 64725-1021_a30dae23-cefc-4d9b-bd47-44a33cba2afc 64725-1021 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120112 ANDA ANDA062713 TYA Pharmaceuticals CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 64725-1053_684cc89b-47f5-4a11-a256-14f36484cf8d 64725-1053 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 TYA Pharmaceuticals BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 64725-1100_1d38892a-0a36-46eb-9f99-7b91b7337fd8 64725-1100 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090774 TYA Pharmaceuticals DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-1110_8cac22bb-9205-4c92-a5ae-912ac62e632a 64725-1110 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 TYA Pharmaceuticals PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 64725-1117_4b21397b-a3cf-4651-8b30-e80e8600e00c 64725-1117 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20030619 ANDA ANDA076312 TYA Pharmaceuticals MIRTAZAPINE 15 mg/1 E 20171231 64725-1130_bcac1969-90c5-4abe-a3af-94566ef8a85c 64725-1130 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 TYA Pharmaceuticals LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 64725-1258_b1dfde1b-4727-42f6-8fd7-80590567f59a 64725-1258 HUMAN OTC DRUG antacid calcium carbonate TABLET, CHEWABLE ORAL 19920807 OTC MONOGRAPH FINAL part331 TYA Pharmaceuticals CALCIUM CARBONATE 500 mg/1 E 20171231 64725-1260_089b76b6-71af-4893-bb1b-4890fcc4a3e5 64725-1260 HUMAN PRESCRIPTION DRUG Clozaril clozapine TABLET ORAL 19890930 NDA NDA019758 TYA Pharmaceuticals CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-1324_137ab467-1a5e-4159-a27d-54700ff0369e 64725-1324 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 TYA Pharmaceuticals DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 64725-1342_15c801e2-01c5-44b4-b323-a8674b83bd29 64725-1342 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 TYA Pharmaceuticals LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 64725-1397_e4d5f9da-e10d-40ca-8abd-66d2de237db1 64725-1397 HUMAN PRESCRIPTION DRUG Chlorpromazine hydrochloride Chlorpromazine hydrochloride INJECTION INTRAMUSCULAR 19740725 ANDA ANDA083329 TYA Pharmaceuticals CHLORPROMAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 64725-1438_1069b2e7-e199-4a74-aa49-19a754d3b70d 64725-1438 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 19871016 ANDA ANDA089586 TYA Pharmaceuticals FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 64725-1460_660d34a2-7e21-47d1-a575-79cae6458114 64725-1460 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 TYA Pharmaceuticals TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] E 20171231 64725-1473_f2b2764d-88e6-41cd-8b7d-be9d82f3ecc0 64725-1473 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19851204 ANDA ANDA088832 TYA Pharmaceuticals PREDNISONE 10 mg/1 E 20171231 64725-1487_15986746-62f9-4539-969a-da2396a26bcc 64725-1487 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 TYA Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 64725-1488_15986746-62f9-4539-969a-da2396a26bcc 64725-1488 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 TYA Pharmaceuticals AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 64725-1690_5d0038f2-5d2e-45c3-b5eb-4ac969b02172 64725-1690 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 TYA Pharmaceuticals HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 64725-1700_164c974d-9ffb-498f-8eb6-75fa4627105e 64725-1700 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130321 ANDA ANDA202389 TYA Pharmaceuticals ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-1782_4e92d5c6-3c12-4817-8ce9-c322dca29445 64725-1782 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19860924 ANDA ANDA070172 TYA Pharmaceuticals NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] E 20171231 64725-1833_a2c745d7-1b63-4064-b6a1-e18e43b318ad 64725-1833 HUMAN OTC DRUG Novolin R Human Insulin INJECTION, SOLUTION SUBCUTANEOUS 19910625 NDA NDA019938 TYA Pharmaceuticals INSULIN HUMAN 100 [iU]/mL E 20171231 64725-1834_88240c8b-10c5-43b4-8a36-020380cea930 64725-1834 HUMAN OTC DRUG Novolin N Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 19910701 NDA NDA019959 TYA Pharmaceuticals INSULIN HUMAN 100 [iU]/mL E 20171231 64725-1837_05dc7def-3137-4c5c-8d43-2baf9d7888df 64725-1837 HUMAN OTC DRUG Novolin 70/30 Human Insulin INJECTION, SUSPENSION SUBCUTANEOUS 19910625 NDA NDA019991 TYA Pharmaceuticals INSULIN HUMAN 100 [USP'U]/mL E 20171231 64725-1924_c9ed63e2-1504-45d7-a33c-94afe98ca244 64725-1924 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 TYA Pharmaceuticals BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII E 20171231 64725-1945_123b4dce-02c1-4b3b-a688-cac53b0d7a94 64725-1945 HUMAN OTC DRUG RULOX REGULAR aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110105 OTC MONOGRAPH FINAL part331 TYA Pharmaceuticals ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL E 20171231 64725-2057_70bd0f0c-73c3-4b70-8fed-7bcd87723d1a 64725-2057 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20121018 ANDA ANDA075269 TYA Pharmaceuticals NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 64725-2164_85fb1966-59ca-453a-8a7f-17092ef729aa 64725-2164 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 TYA Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-2168_85fb1966-59ca-453a-8a7f-17092ef729aa 64725-2168 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 TYA Pharmaceuticals ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-2202_a105e034-4303-43be-bad9-48101881e9a9 64725-2202 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071428 TYA Pharmaceuticals TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-2220_7d9b3b09-2b30-40a4-8b37-38d2e6af3abf 64725-2220 HUMAN PRESCRIPTION DRUG Lantus insulin glargine INJECTION, SOLUTION SUBCUTANEOUS 20090923 NDA NDA021081 TYA Pharmaceuticals INSULIN GLARGINE 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 64725-2434_f3659fef-8fd1-4576-8233-ffaafd41a514 64725-2434 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040742 TYA Pharmaceuticals BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 64725-2435_f3659fef-8fd1-4576-8233-ffaafd41a514 64725-2435 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040715 TYA Pharmaceuticals BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 64725-2527_d1a3410e-fc15-4b8f-8a9c-41c90a0302ad 64725-2527 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19801126 NDA NDA017812 TYA Pharmaceuticals LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 64725-2810_ff75d29a-d733-4f97-aaa5-7d998ef75aa1 64725-2810 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride FLUPHENAZINE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR 20101228 ANDA ANDA089556 TYA Pharmaceuticals FLUPHENAZINE HYDROCHLORIDE 2.5 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 64725-2957_26fe7a22-53d6-4b55-b20f-d88c0f7f75b6 64725-2957 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 TYA Pharmaceuticals CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 64725-3004_3cd86690-cc3e-47ae-bcc1-2a2690d45ed4 64725-3004 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 TYA Pharmaceuticals CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-3005_3cd86690-cc3e-47ae-bcc1-2a2690d45ed4 64725-3005 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 TYA Pharmaceuticals CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-3159_5b3c9704-3969-4194-8861-afdf5b27491a 64725-3159 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20111024 ANDA ANDA201588 TYA Pharmaceuticals OLANZAPINE 10 mg/2mL Atypical Antipsychotic [EPC] E 20171231 64725-3228_418efa18-077c-43db-9b9a-ce25d59d4e10 64725-3228 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 TYA Pharmaceuticals ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] E 20171231 64725-3339_bb523010-0b3c-46b5-832e-692539312f68 64725-3339 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 TYA Pharmaceuticals DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 64725-3920_00a908e6-006f-489e-bf83-f565f9f320c2 64725-3920 HUMAN PRESCRIPTION DRUG Geodon ziprasidone mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR 20031223 NDA NDA020919 TYA Pharmaceuticals ZIPRASIDONE MESYLATE 20 mg/mL Atypical Antipsychotic [EPC] E 20171231 64725-3925_d5ea54f6-0d98-44f1-8839-e81fa0515843 64725-3925 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071307 TYA Pharmaceuticals DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-3926_d5ea54f6-0d98-44f1-8839-e81fa0515843 64725-3926 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071321 TYA Pharmaceuticals DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-4005_bd525ac0-d234-4a1d-936a-7c485882b41f 64725-4005 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 TYA Pharmaceuticals CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 64725-4067_782770e7-b6bd-4ed0-b7b7-99efc7b392cd 64725-4067 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071994 TYA Pharmaceuticals PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 64725-4111_cb714702-6d2b-4987-8045-3586baf12337 64725-4111 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20060905 ANDA ANDA040684 TYA Pharmaceuticals PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 64725-4887_ced3e7f6-f45e-4010-bc4f-96fa860f5b90 64725-4887 HUMAN PRESCRIPTION DRUG Sterile Water WATER INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20110915 NDA NDA018801 TYA Pharmaceuticals WATER 1 mL/mL E 20171231 64725-5150_5d172892-ed60-4914-934b-74c9771a2d5b 64725-5150 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 TYA Pharmaceuticals LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 64725-5181_92ad9b07-4bf9-4044-a6a0-d21001e8c491 64725-5181 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 TYA Pharmaceuticals LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 64725-5307_e2d3bab5-9ad3-4469-81a1-b6fda90d0067 64725-5307 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 TYA Pharmaceuticals PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 64725-5375_1bb4e48b-8113-4789-a602-377dbf517c8b 64725-5375 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 19860513 ANDA ANDA070791 TYA Pharmaceuticals DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 64725-5400_b33bdf2c-8947-4d30-b72f-1364a018446c 64725-5400 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 TYA Pharmaceuticals LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 64725-5440_bee80872-6005-48dd-b96e-de49ba1610a0 64725-5440 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19770214 ANDA ANDA062031 TYA Pharmaceuticals DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 64725-5620_bae49238-5562-46cc-b369-88245b27e91c 64725-5620 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071136 TYA Pharmaceuticals DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-5768_a611a26f-3423-40f9-a498-23ccd3e1122c 64725-5768 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 TYA Pharmaceuticals OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-5790_b6f855b9-e909-4163-b6c9-892239ae2a07 64725-5790 HUMAN PRESCRIPTION DRUG PROAIR HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20121203 NDA NDA021457 TYA Pharmaceuticals ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 64725-5895_0f3e08a2-667b-48cf-b9ce-2ca878a74081 64725-5895 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 19971020 ANDA ANDA074612 TYA Pharmaceuticals NICOTINE 14 mg/24h E 20171231 64725-5896_f7ac6da1-10d4-46d7-99c4-40818d97c911 64725-5896 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 19971020 ANDA ANDA074612 TYA Pharmaceuticals NICOTINE 21 mg/24h E 20171231 64725-5914_298c7401-c635-4aa7-8efd-f5df0a90008e 64725-5914 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084112 TYA Pharmaceuticals CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 64725-5916_298c7401-c635-4aa7-8efd-f5df0a90008e 64725-5916 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 19740709 ANDA ANDA084114 TYA Pharmaceuticals CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 64725-6044_9b3bd7a5-718a-4dd9-a908-4fa279c94621 64725-6044 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 19800725 NDA NDA018140 TYA Pharmaceuticals LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 64725-7544_e57024b0-ec2c-4e78-9294-646374b41871 64725-7544 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090783 TYA Pharmaceuticals DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 64725-7597_5f3acc57-5fb6-4042-adf8-c2db2f41d0f8 64725-7597 HUMAN PRESCRIPTION DRUG ZYPREXA Intramuscular Olanzapine INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR 20040401 NDA NDA021253 TYA Pharmaceuticals OLANZAPINE 10 mg/2mL Atypical Antipsychotic [EPC] E 20171231 64725-7915_a4a288bd-5325-40f0-a03f-abb9b68b609c 64725-7915 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 OTC MONOGRAPH NOT FINAL part343 TYA Pharmaceuticals IBUPROFEN 200 mg/1 E 20171231 64725-8000_86ddf799-88d3-4d05-ae29-34e13a89cd22 64725-8000 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 TYA Pharmaceuticals ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 64725-8031_ba0c7c30-0246-4de1-82f6-3208baadda05 64725-8031 HUMAN PRESCRIPTION DRUG Glucagon glucagon KIT 19990301 NDA NDA020928 TYA Pharmaceuticals E 20171231 64725-8166_bf422cc2-9c69-4cf2-9a5b-22adee95ccf6 64725-8166 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 TYA Pharmaceuticals QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 64735-060_f825b8ce-57e8-45ff-ae70-420e8057efb1 64735-060 HUMAN PRESCRIPTION DRUG Carbon Dioxide Oxygen Mixture Carbon Dioxide Oxygen Mixture GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Air Liquide Healthcare America Corporation OXYGEN; CARBON DIOXIDE 95; 5 L/100L; L/100L Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] E 20171231 64735-070_2c1e32b8-7d04-46a2-bffe-e5d541bb087a 64735-070 HUMAN PRESCRIPTION DRUG COMPRESSED GAS, OXIDIZING, N.O.S. OXYGEN GAS RESPIRATORY (INHALATION) 19600101 NDA NDA205712 Air Liquide Healthcare America Corporation OXYGEN 40 L/100L E 20171231 64735-080_7777e939-2a5d-4af2-918d-f1f80e317e0c 64735-080 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 19600101 UNAPPROVED MEDICAL GAS Air Liquide Healthcare America Corporation OXYGEN; NITROGEN 23; 77 L/100L; L/100L E 20171231 64745-001_09ccc52f-c816-4423-9e1c-f1e4f4aa9f8d 64745-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS COPD-LLC Respiratory Services OXYGEN 99 L/100L E 20171231 64760-200_48629641-620a-4a5e-b285-cbd56187081d 64760-200 HUMAN PRESCRIPTION DRUG Glytone Clarifying hydroquinone CREAM TOPICAL 20100401 UNAPPROVED DRUG OTHER Genesis Pharmaceutical, Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 64760-202_fbf59ede-100d-42c9-9988-cb9497b85ef0 64760-202 HUMAN PRESCRIPTION DRUG Glytone Clarifying Hydroquinone GEL TOPICAL 20101109 UNAPPROVED DRUG OTHER Genesis Pharmaceutical, Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 64760-203_5607d2fb-8ff5-4a20-afcc-19d5fa6bddc4 64760-203 HUMAN OTC DRUG Glytone Essentials Rejuvenate daily avobenzone, octinoxate LOTION TOPICAL 20100520 OTC MONOGRAPH FINAL part352 Genesis Pharmaceutical OCTINOXATE; AVOBENZONE 4.2; 1.2 mL/60mL; mL/60mL E 20171231 64760-204_681828cd-4ed8-4b2b-aebf-f35dba341082 64760-204 HUMAN OTC DRUG Glytone essentials rejuvenate daily Avobenzone, octinoxate CREAM TOPICAL 20100520 OTC MONOGRAPH FINAL part352 Glytone AVOBENZONE; OCTINOXATE 1; 3 mL/50mL; mL/50mL E 20171231 64760-208_fb08a86b-2bca-499c-b2ea-736192f29614 64760-208 HUMAN OTC DRUG glytone retexturize body octinoxate, octisalate, oxybenzone LOTION TOPICAL 20100519 OTC MONOGRAPH NOT FINAL part352 Glytone OCTINOXATE; OCTISALATE; OXYBENZONE 18.75; 12.5; 7.5 mL/250mL; mL/250mL; mL/250mL E 20171231 64760-213_c0b0923a-1e7f-4523-a01d-4430397116a5 64760-213 HUMAN OTC DRUG Glytone Acne Back Salicylic acid SPRAY TOPICAL 20100401 20180831 OTC MONOGRAPH FINAL part333D Genesis Pharmaceutical, Inc. SALICYLIC ACID 20 mg/mL E 20171231 64760-215_f45342bf-d157-419d-a03c-c3e20d6a6505 64760-215 HUMAN OTC DRUG Glytone Sunscreen SPF 40 Octinoxate, Octisalate, Zinc oxide LOTION TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part352 Genesis Pharmaceutical, Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 20; 76.5 mg/mL; mg/mL; mg/mL N 20181231 64760-219_19fcf049-b388-4396-b0e2-cc27bad1d70d 64760-219 HUMAN OTC DRUG Glytone acne treatment facial cleanser salicylic acid LIQUID TOPICAL 20100101 OTC MONOGRAPH FINAL part358H Glytone SALICYLIC ACID 4 mL/200mL E 20171231 64760-301_737bcf3a-2737-4be8-b8b7-097eb984f9aa 64760-301 HUMAN OTC DRUG Glytone acne self cleanser salicylic acid AEROSOL, FOAM TOPICAL 20101012 OTC MONOGRAPH FINAL part333D Genesis SALICYLIC ACID .5 mL/100mL E 20171231 64760-302_22eb3861-899b-456c-9167-83431c233d8c 64760-302 HUMAN OTC DRUG Glytone acne 3P benzoyl peroxide GEL TOPICAL 20101015 OTC MONOGRAPH NOT FINAL part333D Genesis Pharmaceuticals BENZOYL PEROXIDE 3 mL/60mL E 20171231 64760-401_e6fa580b-51ff-4ef9-afbd-caa764539645 64760-401 HUMAN PRESCRIPTION DRUG Glytone Clarifying SunVanish with Sunscreen Hydroquinone CREAM TOPICAL 20120613 UNAPPROVED DRUG OTHER Genesis Pharmaceutical, Inc. HYDROQUINONE; OCTINOXATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 40; 75; 50; 20; 18.6 mg/g; mg/g; mg/g; mg/g; mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 64760-408_0e45b33d-ff71-4c2c-80d3-75687c31b43f 64760-408 HUMAN OTC DRUG Glytone Body Octinoxate, Oxybenzone, Avobenzene, Octocrylene LOTION TOPICAL 20120612 OTC MONOGRAPH FINAL part352 Genesis Pharmaceutical OCTINOXATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 26.63; 10.65; 7.1; 6.6 mL/355mL; mL/355mL; mL/355mL; mL/355mL E 20171231 64760-601_a33d46d1-6a91-4be8-b19a-4e6af7f8302a 64760-601 HUMAN OTC DRUG WOMENS alopexy minoxidil SOLUTION TOPICAL 20160808 ANDA ANDA078176 Genesis Pharmaceutical, Inc. MINOXIDIL 20 mg/mL N 20181231 64760-602_70bd1712-d290-4c9b-8c0d-919354a5c489 64760-602 HUMAN OTC DRUG MENS alopexy minoxidil SOLUTION TOPICAL 20160808 ANDA ANDA076239 Genesis Pharmaceutical, Inc. MINOXIDIL 50 mg/mL N 20181231 64760-706_eda24665-d2c0-43d3-8eeb-bf81651c77fa 64760-706 HUMAN OTC DRUG Glytone Acne Clearing Toner salicylic acid SOLUTION TOPICAL 20161021 OTC MONOGRAPH FINAL part333D Genesis Pharmaceutical, Inc. SALICYLIC ACID 20 mg/mL N 20181231 64760-708_22f19e97-e5e5-483e-915f-23c7dcbfe91c 64760-708 HUMAN OTC DRUG Glytone Acne Spot Treatment sulfur, resorcinol LOTION TOPICAL 20161021 OTC MONOGRAPH FINAL part333D Genesis Pharmaceutical, Inc. RESORCINOL; SULFUR 20; 80 mg/mL; mg/mL N 20181231 64760-712_62658b80-0c3f-47a6-b3f5-0871643ea4bd 64760-712 HUMAN OTC DRUG GLYTONE Acne BPO Clearing Cleanser benzoyl peroxide LOTION TOPICAL 20170301 OTC MONOGRAPH FINAL part333D Genesis Pharmaceutical, Inc. BENZOYL PEROXIDE 45 mg/mL N 20181231 64760-717_277da8d5-bf98-4e29-b9f0-cf6eae20d00a 64760-717 HUMAN OTC DRUG GLYTONE Triple Defense Brightening Complex with Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20170220 OTC MONOGRAPH NOT FINAL part352 Genesis Pharmaceutical, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 64762-861_3702b6c1-6071-40e9-8fc8-1a3e5c7f6ffe 64762-861 HUMAN OTC DRUG NBB Cherry Zinc Gluconate, Zinc Oxide, and Sambucus Nigra Flower TABLET, ORALLY DISINTEGRATING ORAL 20091104 UNAPPROVED HOMEOPATHIC Dynamic Pharmaceuticals Inc. ZINC GLUCONATE; ZINC OXIDE; SAMBUCUS NIGRA FLOWER 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 64762-862_c4b19477-d349-49ae-9cad-167ab21899b1 64762-862 HUMAN OTC DRUG NBB ZINC OXIDE, ZINC GLUCONATE, AND SAMBUCUS NIGRA FLOWERING TOP SPRAY, METERED ORAL 20100601 OTC MONOGRAPH FINAL part341 Dynamic Pharmaceuticals Inc. ZINC OXIDE; ZINC GLUCONATE; SAMBUCUS NIGRA FLOWERING TOP .25; 12.42; .05 mg/mL; mg/mL; mg/mL E 20171231 64762-864_87057c78-4215-4840-a11b-82d7aa9f66e3 64762-864 HUMAN OTC DRUG Oxymetazoline Hydrochloride Oxymetazoline Hydrochloride SPRAY, METERED NASAL 20091104 OTC MONOGRAPH FINAL part341 Dynamic Pharmaceuticals OXYMETAZOLINE HYDROCHLORIDE .2 mg/.4mL E 20171231 64762-865_0e55c145-6fc7-4800-9082-0e25f6a2161a 64762-865 HUMAN OTC DRUG Oxymetazoline Hydrochloride Oxymetazoline Hydrochloride SPRAY, METERED NASAL 20091104 OTC MONOGRAPH FINAL part341 Dynamic Pharmaceuticals OXYMETAZOLINE HYDROCHLORIDE .2 mg/.4mL E 20171231 64762-870_c9b3921f-277f-48c3-8816-aebbeb1754ff 64762-870 HUMAN OTC DRUG NBB Citrus Zinc Gluconate, Zinc Oxide, and Sambucus Nigra Flower TABLET, ORALLY DISINTEGRATING ORAL 20091104 UNAPPROVED HOMEOPATHIC Dynamic Pharmaceuticals Inc. ZINC GLUCONATE; ZINC OXIDE; SAMBUCUS NIGRA FLOWER 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 64762-871_520e00c4-69d8-444e-9da0-8d965fad158a 64762-871 HUMAN OTC DRUG NBE ZINC GLUCONATE and ZINC ACETATE SPRAY, METERED ORAL 20100930 OTC MONOGRAPH FINAL part347 Dynamic Pharmaceuticals Inc. ZINC GLUCONATE; ZINC ACETATE 12.26; .46 mg/mL; mg/mL E 20171231 64762-873_789d4fd7-b279-4f6f-ae19-4eced611b7b3 64762-873 HUMAN OTC DRUG NBE Citrus Cold Remedy Fast Melting (Rite Aid) Zinc Acetate and Zinc Gluconate TABLET, ORALLY DISINTEGRATING ORAL 20101004 UNAPPROVED HOMEOPATHIC Dynamic Pharmaceuticals Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 E 20171231 64762-874_2ecb6196-4b51-4c44-9b2e-08427183b629 64762-874 HUMAN OTC DRUG NBE Cherry Cold Remedy Fast Melting (Rite Aid) Zinc Acetate and Zinc Gluconate TABLET, ORALLY DISINTEGRATING ORAL 20101004 UNAPPROVED HOMEOPATHIC Dynamic Pharmaceuticals Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 E 20171231 64762-884_f4acd8a0-fe19-4eed-800a-8f11363129c9 64762-884 HUMAN OTC DRUG NBE Cool Mint Cold Remedy Fast Melting ZINC GLUCONATE LOZENGE ORAL 20110801 UNAPPROVED HOMEOPATHIC Dynamic Pharmaceuticals Inc. ZINC GLUCONATE 1 [hp_X]/1 E 20171231 64763-099_887ad055-94df-4d43-991e-4e411edbbe3a 64763-099 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20020101 NDA NDA205767 Johnson Drug Company, Inc OXYGEN 99 L/100L N 20181231 64764-046_632a4c95-6a54-4e3f-9539-8f75d8b9c6d9 64764-046 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 19950510 NDA NDA020406 Takeda Pharmaceuticals America, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 64764-080_25bf735c-04fe-4067-8108-21956899b68b 64764-080 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20060131 NDA NDA021908 Takeda Pharmaceuticals America, Inc. LUBIPROSTONE 8 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] N 20181231 64764-119_4af9ac7f-2a0c-4fed-ba20-ba8b4d838e69 64764-119 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20090901 NDA NDA022352 Takeda Pharmaceuticals America, Inc. COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20191231 64764-121_20e6f93c-e116-4328-9c92-e34e7035b6f2 64764-121 HUMAN PRESCRIPTION DRUG OSENI alogliptin and pioglitazone TABLET, FILM COATED ORAL 20130125 NDA NDA022426 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 12.5; 15 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 64764-123_20e6f93c-e116-4328-9c92-e34e7035b6f2 64764-123 HUMAN PRESCRIPTION DRUG OSENI alogliptin and pioglitazone TABLET, FILM COATED ORAL 20130125 NDA NDA022426 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 12.5; 30 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 64764-124_20e6f93c-e116-4328-9c92-e34e7035b6f2 64764-124 HUMAN PRESCRIPTION DRUG OSENI alogliptin and pioglitazone TABLET, FILM COATED ORAL 20130125 NDA NDA022426 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 12.5; 45 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 64764-125_ef1996d2-d0f0-4080-8762-ec94ee687225 64764-125 HUMAN PRESCRIPTION DRUG Nesina alogliptin TABLET, FILM COATED ORAL 20130125 NDA NDA022271 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE 12.5 mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] N 20191231 64764-151_bb7e3075-8f66-4257-a6c7-bfc34a1cc0bc 64764-151 HUMAN PRESCRIPTION DRUG Actos pioglitazone TABLET ORAL 19990715 NDA NDA021073 Takeda Pharmaceuticals America, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 64764-155_9b5615cb-1b1a-4e2a-83ea-0e6b70a5920b 64764-155 HUMAN PRESCRIPTION DRUG Actoplus Met pioglitazone and metformin hydrochloride TABLET, FILM COATED ORAL 20050829 NDA NDA021842 Takeda Pharmaceuticals America, Inc. PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 500 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 64764-158_9b5615cb-1b1a-4e2a-83ea-0e6b70a5920b 64764-158 HUMAN PRESCRIPTION DRUG Actoplus Met pioglitazone and metformin hydrochloride TABLET, FILM COATED ORAL 20050829 NDA NDA021842 Takeda Pharmaceuticals America, Inc. PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 850 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 64764-171_5a2130f7-fd80-40ef-8190-51e68f147bb0 64764-171 HUMAN PRESCRIPTION DRUG Dexilant dexlansoprazole CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022287 Takeda Pharmaceuticals America, Inc. DEXLANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 64764-175_5a2130f7-fd80-40ef-8190-51e68f147bb0 64764-175 HUMAN PRESCRIPTION DRUG Dexilant dexlansoprazole CAPSULE, DELAYED RELEASE ORAL 20100412 NDA NDA022287 Takeda Pharmaceuticals America, Inc. DEXLANSOPRAZOLE 60 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 64764-240_25bf735c-04fe-4067-8108-21956899b68b 64764-240 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20060131 NDA NDA021908 Takeda Pharmaceuticals America, Inc. LUBIPROSTONE 24 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] N 20181231 64764-250_ef1996d2-d0f0-4080-8762-ec94ee687225 64764-250 HUMAN PRESCRIPTION DRUG Nesina alogliptin TABLET, FILM COATED ORAL 20130125 NDA NDA022271 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE 25 mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] N 20191231 64764-251_20e6f93c-e116-4328-9c92-e34e7035b6f2 64764-251 HUMAN PRESCRIPTION DRUG OSENI alogliptin and pioglitazone TABLET, FILM COATED ORAL 20130125 NDA NDA022426 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 25; 15 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 64764-253_20e6f93c-e116-4328-9c92-e34e7035b6f2 64764-253 HUMAN PRESCRIPTION DRUG OSENI alogliptin and pioglitazone TABLET, FILM COATED ORAL 20130125 NDA NDA022426 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 25; 30 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 64764-254_20e6f93c-e116-4328-9c92-e34e7035b6f2 64764-254 HUMAN PRESCRIPTION DRUG OSENI alogliptin and pioglitazone TABLET, FILM COATED ORAL 20130125 NDA NDA022426 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE 25; 45 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 64764-300_10469e7f-732d-41e5-8467-e1f582c31fd1 64764-300 HUMAN PRESCRIPTION DRUG Entyvio vedolizumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140520 BLA BLA125476 Takeda Pharmaceuticals America, Inc. VEDOLIZUMAB 300 mg/5mL Integrin Receptor Antagonist [EPC],Integrin Receptor Antagonists [MoA] N 20191231 64764-301_bb7e3075-8f66-4257-a6c7-bfc34a1cc0bc 64764-301 HUMAN PRESCRIPTION DRUG Actos pioglitazone TABLET ORAL 19990715 NDA NDA021073 Takeda Pharmaceuticals America, Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 64764-302_c9a8c94a-ec35-4182-8fc8-c1bfdd3a1958 64764-302 HUMAN PRESCRIPTION DRUG Duetact pioglitazone and glimepiride TABLET ORAL 20060728 NDA NDA021925 Takeda Pharmaceuticals America, Inc. PIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE 30; 2 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 64764-304_c9a8c94a-ec35-4182-8fc8-c1bfdd3a1958 64764-304 HUMAN PRESCRIPTION DRUG Duetact pioglitazone and glimepiride TABLET ORAL 20060728 NDA NDA021925 Takeda Pharmaceuticals America, Inc. PIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE 30; 4 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 64764-310_f011044c-2821-48b5-bfa2-5f20ee465bb9 64764-310 HUMAN PRESCRIPTION DRUG Actoplus Met XR pioglitazone and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100611 NDA NDA022024 Takeda Pharmaceuticals America, Inc. PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 30; 1000 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 64764-335_21fe473e-7ecf-483e-9003-a95200b5433b 64764-335 HUMAN PRESCRIPTION DRUG KAZANO alogliptin and metformin hydrochloride TABLET, FILM COATED ORAL 20130125 NDA NDA203414 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE 12.5; 500 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] N 20181231 64764-337_21fe473e-7ecf-483e-9003-a95200b5433b 64764-337 HUMAN PRESCRIPTION DRUG KAZANO alogliptin and metformin hydrochloride TABLET, FILM COATED ORAL 20130125 NDA NDA203414 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE 12.5; 1000 mg/1; mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 64764-451_bb7e3075-8f66-4257-a6c7-bfc34a1cc0bc 64764-451 HUMAN PRESCRIPTION DRUG Actos pioglitazone TABLET ORAL 19990715 NDA NDA021073 Takeda Pharmaceuticals America, Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 64764-510_f011044c-2821-48b5-bfa2-5f20ee465bb9 64764-510 HUMAN PRESCRIPTION DRUG Actoplus Met XR pioglitazone and metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100611 NDA NDA022024 Takeda Pharmaceuticals America, Inc. PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 1000 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 64764-541_632a4c95-6a54-4e3f-9539-8f75d8b9c6d9 64764-541 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 19950510 NDA NDA020406 Takeda Pharmaceuticals America, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 64764-543_632a4c95-6a54-4e3f-9539-8f75d8b9c6d9 64764-543 HUMAN PRESCRIPTION DRUG Prevacid SoluTab lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20020830 NDA NDA021428 Takeda Pharmaceuticals America, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 64764-544_632a4c95-6a54-4e3f-9539-8f75d8b9c6d9 64764-544 HUMAN PRESCRIPTION DRUG Prevacid SoluTab lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20020830 NDA NDA021428 Takeda Pharmaceuticals America, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 64764-550_cc70d6dd-e54b-483d-83f5-762a6cce455a 64764-550 HUMAN PRESCRIPTION DRUG Brintellix vortioxetine TABLET, FILM COATED ORAL 20131002 NDA NDA204447 Takeda Pharmaceuticals America, Inc. VORTIOXETINE HYDROBROMIDE 5 mg/1 E 20171231 64764-560_cc70d6dd-e54b-483d-83f5-762a6cce455a 64764-560 HUMAN PRESCRIPTION DRUG Brintellix vortioxetine TABLET, FILM COATED ORAL 20131002 NDA NDA204447 Takeda Pharmaceuticals America, Inc. VORTIOXETINE HYDROBROMIDE 10 mg/1 E 20171231 64764-570_cc70d6dd-e54b-483d-83f5-762a6cce455a 64764-570 HUMAN PRESCRIPTION DRUG Brintellix vortioxetine TABLET, FILM COATED ORAL 20131002 NDA NDA204447 Takeda Pharmaceuticals America, Inc. VORTIOXETINE HYDROBROMIDE 15 mg/1 E 20171231 64764-580_cc70d6dd-e54b-483d-83f5-762a6cce455a 64764-580 HUMAN PRESCRIPTION DRUG Brintellix vortioxetine TABLET, FILM COATED ORAL 20131002 NDA NDA204447 Takeda Pharmaceuticals America, Inc. VORTIOXETINE HYDROBROMIDE 20 mg/1 E 20171231 64764-625_ef1996d2-d0f0-4080-8762-ec94ee687225 64764-625 HUMAN PRESCRIPTION DRUG Nesina alogliptin TABLET, FILM COATED ORAL 20130125 NDA NDA022271 Takeda Pharmaceuticals America, Inc. ALOGLIPTIN BENZOATE 6.25 mg/1 Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] N 20191231 64764-677_2086116f-ebb2-47ee-a741-30a7f71c4451 64764-677 HUMAN PRESCRIPTION DRUG ULORIC febuxostat TABLET ORAL 20090213 NDA NDA021856 Takeda Pharmaceuticals America, Inc. FEBUXOSTAT 80 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 64764-702_8f825259-69e0-41ba-a249-a649cb3edc7e 64764-702 HUMAN PRESCRIPTION DRUG PREVPAC lansoprazole, amoxicillin and clarithromycin KIT 19971202 NDA NDA050757 Takeda Pharmaceuticals America, Inc. N 20191231 64764-720_fc117e75-5c73-4373-ad38-76b73bfc6073 64764-720 HUMAN PRESCRIPTION DRUG Trintellix vortioxetine TABLET, FILM COATED ORAL 20131002 NDA NDA204447 Takeda Pharmaceuticals America, Inc. VORTIOXETINE HYDROBROMIDE 5 mg/1 N 20181231 64764-730_fc117e75-5c73-4373-ad38-76b73bfc6073 64764-730 HUMAN PRESCRIPTION DRUG Trintellix vortioxetine TABLET, FILM COATED ORAL 20131002 NDA NDA204447 Takeda Pharmaceuticals America, Inc. VORTIOXETINE HYDROBROMIDE 10 mg/1 N 20181231 64764-750_fc117e75-5c73-4373-ad38-76b73bfc6073 64764-750 HUMAN PRESCRIPTION DRUG Trintellix vortioxetine TABLET, FILM COATED ORAL 20131002 NDA NDA204447 Takeda Pharmaceuticals America, Inc. VORTIOXETINE HYDROBROMIDE 20 mg/1 N 20181231 64764-805_99879053-417b-40e8-bf64-b6598e01874b 64764-805 HUMAN PRESCRIPTION DRUG Rozerem ramelteon TABLET, FILM COATED ORAL 20050722 NDA NDA021782 Takeda Pharmaceuticals America, Inc. RAMELTEON 8 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] N 20191231 64764-890_ed2da3a6-0614-4bea-8e82-962cbaae6428 64764-890 HUMAN PRESCRIPTION DRUG CONTRAVE naltrexone hydrochloride and bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140910 NDA NDA200063 Takeda Pharmaceuticals America, Inc. NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE 8; 90 mg/1; mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA],Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 64764-918_2086116f-ebb2-47ee-a741-30a7f71c4451 64764-918 HUMAN PRESCRIPTION DRUG ULORIC febuxostat TABLET ORAL 20090213 NDA NDA021856 Takeda Pharmaceuticals America, Inc. FEBUXOSTAT 40 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 64764-944_90260686-0297-4334-b577-5cdb3f0a3129 64764-944 HUMAN PRESCRIPTION DRUG Edarbyclor azilsartan medoxomil and chlorthalidone TABLET ORAL 20111223 20180501 NDA NDA202331 Takeda Pharmaceuticals America, Inc. AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE 40; 12.5 mg/1; mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 64764-994_90260686-0297-4334-b577-5cdb3f0a3129 64764-994 HUMAN PRESCRIPTION DRUG Edarbyclor azilsartan medoxomil and chlorthalidone TABLET ORAL 20111223 20180501 NDA NDA202331 Takeda Pharmaceuticals America, Inc. AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE 40; 25 mg/1; mg/1 Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 64768-2922_27706371-660e-4847-914e-2f33b531ded6 64768-2922 HUMAN OTC DRUG MUSTELA Diaper rash 1 2 3 ZINC OXIDE CREAM TOPICAL 20170109 OTC MONOGRAPH FINAL part347 Expanscience Laboratories d/b/a Mustela ZINC OXIDE 9.9 g/100g N 20181231 64768-2923_ba0b23bb-41a1-44b6-bc29-6729646d9005 64768-2923 HUMAN OTC DRUG Mustela Broad spectrum SPF 50 plus mineral sunscreen TITANIUM DIOXIDE and ZINC OXIDE STICK TOPICAL 20150701 OTC MONOGRAPH FINAL part352 Expanscience Laboratories d/b/a Mustela TITANIUM DIOXIDE; ZINC OXIDE 6; 4.7 g/100g; g/100g N 20181231 64772-126_febc98f6-5fa6-477b-bfa1-ec1011805653 64772-126 HUMAN OTC DRUG DERMA GRAN Aluminium Hydroxide OINTMENT TOPICAL 20150616 OTC MONOGRAPH FINAL part347 Derma Sciences Canada, Inc. ALGELDRATE .275 g/100g E 20171231 64772-127_524dd57e-96e2-4c95-a788-7575a7553d99 64772-127 HUMAN OTC DRUG DERMA GRAN Zinc Acetate SPRAY TOPICAL 20150420 OTC MONOGRAPH FINAL part347 Derma Sciences Canada, Inc. ZINC ACETATE .1 g/100g E 20171231 64772-300_7ef17f63-6f4f-44a0-a89f-479ce9ee68da 64772-300 HUMAN OTC DRUG Primer Zinc Oxide, Calamine DRESSING TOPICAL 20100510 OTC MONOGRAPH FINAL part347 Derma Sciences Canada, Inc. ZINC OXIDE; FERRIC OXIDE RED; ZINC OXIDE 25; .015; .985 g/1; g/1; g/1 E 20171231 64772-302_3782c8e9-49e7-4f8a-af24-93c2201133e0 64772-302 HUMAN OTC DRUG Primer Zinc Oxide DRESSING TOPICAL 20100510 OTC MONOGRAPH FINAL part347 Derma Sciences Canada, Inc. ZINC OXIDE 25 g/1 E 20171231 64776-696_ff01f354-ad6b-414f-8d53-44d2b4912106 64776-696 HUMAN OTC DRUG Scent Killer Anti-Perspirant and Deodorant Odorless Formula Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20140408 OTC MONOGRAPH FINAL part350 Wildlife Research Center, Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 22 g/100g E 20171231 64778-0213_5fc8686a-bfcf-77ea-e053-2a91aa0ac5bc 64778-0213 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 19991201 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .0272 g/mL N 20181231 64778-0214_2ec74fc5-58bc-462c-879e-653c36825968 64778-0214 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 19991001 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL N 20181231 64778-0215_6014cea6-0d08-14c2-e053-2a91aa0a9666 64778-0215 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 19991001 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .0272 g/mL N 20181231 64778-0216_60153ce5-b80a-17b1-e053-2a91aa0a18c0 64778-0216 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 19991001 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .0272 g/mL N 20181231 64778-0217_60155f6a-8cf4-1cdb-e053-2991aa0a1d67 64778-0217 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 20000301 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .0272 g/mL N 20181231 64778-0218_84631a8e-2f4e-43d1-88bb-e2faa5045695 64778-0218 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 20050401 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL N 20181231 64778-0219_601507e0-e151-3abb-e053-2991aa0a6b52 64778-0219 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second Sodium Fluoride GEL DENTAL 20050401 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .0272 g/mL N 20181231 64778-0236_601b6039-df8c-6bb3-e053-2991aa0a5d25 64778-0236 HUMAN PRESCRIPTION DRUG DentiCare Denti-Pro Sodium Fluoride GEL DENTAL 19991103 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .02 g/mL N 20181231 64778-0239_601ba187-56a0-6ec9-e053-2a91aa0a5fd9 64778-0239 HUMAN PRESCRIPTION DRUG Neutral Sodium Fluoride Sodium Fluoride GEL DENTAL 20170223 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .02 g/mL N 20181231 64778-0244_54c5ac06-4efe-049a-e054-00144ff88e88 64778-0244 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconante Chlorhexidine Gluconante RINSE ORAL 20060602 ANDA ANDA077789 AMD Medicom Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 64778-0373_601c1a80-a7b9-f814-e053-2a91aa0ac8d5 64778-0373 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Bubble Gum Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .0272 g/g N 20181231 64778-0375_601be3ea-ceae-dacd-e053-2991aa0a3dad 64778-0375 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Grape Sodium Fluoride AEROSOL, FOAM DENTAL 20030401 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .0272 g/g N 20181231 64778-0376_601b29a5-a3de-25ea-e053-2a91aa0a453d 64778-0376 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Mint Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .0272 g/g N 20181231 64778-0377_601c2075-7e63-07f5-e053-2a91aa0a2d1e 64778-0377 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Orange Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .0272 g/g N 20181231 64778-0378_e1e2a3f0-1849-4d43-b9f0-d573f5c44081 64778-0378 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Raspberry Sodium Fluoride AEROSOL, FOAM DENTAL 20050501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/g N 20181231 64778-0379_601c1a80-a7ad-f814-e053-2a91aa0ac8d5 64778-0379 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Foam Topical Sodium Fluoride Strawberry Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AMD Medicom Inc SODIUM FLUORIDE .0272 g/g N 20181231 64778-0386_601c1f98-ab17-0850-e053-2a91aa0a7d66 64778-0386 HUMAN PRESCRIPTION DRUG Neutral Topical Sodium Fluoride AEROSOL, FOAM DENTAL 20041201 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .02 g/g N 20181231 64778-0388_601c236d-b055-39f4-e053-2991aa0ad716 64778-0388 HUMAN PRESCRIPTION DRUG Neutral Topical Sodium Fluoride AEROSOL, FOAM DENTAL 20041201 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .02 g/g N 20181231 64778-0393_ff82566a-906a-4c3d-b5fa-7f22193733b9 64778-0393 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Bubblegum benzocaine, tetracaine hydrochloride GEL DENTAL 20000201 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE; TETRACAINE HYDROCHLORIDE .18; .02 g/g; g/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 64778-0394_0debe0b5-a32d-4206-808c-f4a5ce648612 64778-0394 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Cherry benzocaine, tetracaine hydrochloride GEL DENTAL 20000401 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE; TETRACAINE HYDROCHLORIDE .18; .02 g/g; g/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 64778-0396_641e77b9-a7d6-4715-84d6-b21e7c14fa60 64778-0396 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Mint benzocaine, tetracaine hydrochloride GEL DENTAL 20000201 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE; TETRACAINE HYDROCHLORIDE .18; .02 g/g; g/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 64778-0398_9109b9d5-693a-4983-aa2c-6fd951434767 64778-0398 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Raspberry benzocaine, tetracaine hydrochloride GEL DENTAL 20050401 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE; TETRACAINE HYDROCHLORIDE .18; .02 g/g; g/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 64778-0399_4776a475-535d-4bcf-b7d6-eb1d68094bd2 64778-0399 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Strawberry benzocaine, tetracaine hydrochloride GEL DENTAL 20000201 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE; TETRACAINE HYDROCHLORIDE .18; .02 g/g; g/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 64778-0446_602c58c8-4b65-2ff0-e053-2991aa0af101 64778-0446 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse Sodium Fluoride LIQUID DENTAL 20010301 UNAPPROVED DRUG OTHER AMD Medicom SODIUM FLUORIDE .02 g/mL N 20181231 64778-0448_602b6481-9302-567d-e053-2a91aa0aaa66 64778-0448 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse Berry Sodium Fluoride LIQUID DENTAL 20010601 UNAPPROVED DRUG OTHER AMD Medicom Inc. SODIUM FLUORIDE .02 g/mL N 20181231 64778-0493_59ca3bac-a5c5-4b23-a748-a75eb657c29b 64778-0493 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Bubblegum benzocaine OINTMENT DENTAL 20050728 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE .2 g/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 64778-0494_5fc9aa93-b323-6f5d-e053-2a91aa0a63cd 64778-0494 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Cherry benzocaine OINTMENT DENTAL 20050728 UNAPPROVED DRUG OTHER AMD Medicom Inc. BENZOCAINE .2 g/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 64778-0496_c67827c0-1d9c-4824-aeda-e30f4976c3d0 64778-0496 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Mint benzocaine OINTMENT DENTAL 20050728 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE .2 g/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 64778-0498_c329a057-f165-44c9-a0f8-adb29269b9d7 64778-0498 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Raspberry benzocaine OINTMENT DENTAL 20050728 UNAPPROVED DRUG OTHER AR Medicom Inc BENZOCAINE .2 g/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 64778-0499_5fc9df48-9e21-c8f4-e053-2a91aa0ae801 64778-0499 HUMAN PRESCRIPTION DRUG Denti-Care Denti-Freeze Topical Anesthetic Strawberry benzocaine OINTMENT DENTAL 20050728 UNAPPROVED DRUG OTHER AMD Medicom Inc. BENZOCAINE .2 g/mL Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 64778-1212_765dd81a-0b10-4707-8d48-f044202b96c3 64778-1212 HUMAN PRESCRIPTION DRUG DentiCare Pro-Gel Sodium Fluoride GEL DENTAL 20050401 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL E 20171231 64778-1213_e9ca9521-00df-4cb2-b26c-1962f17ce6bf 64778-1213 HUMAN PRESCRIPTION DRUG DentiCare Pro-Gel Sodium Fluoride GEL DENTAL 20050401 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/mL E 20171231 64778-1231_8c47c049-4b10-4b7b-836c-12229c6ee059 64778-1231 HUMAN PRESCRIPTION DRUG DentiCare Pro-Gel Sodium Fluoride GEL DENTAL 19991103 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .02 g/mL E 20171231 64778-1232_d026177c-467e-4c93-b356-9f39d3c17b71 64778-1232 HUMAN PRESCRIPTION DRUG DentiCare Pro-Gel Sodium Fluoride GEL DENTAL 19991103 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .02 g/mL E 20171231 64778-1233_66546f71-3ac0-4da0-b293-a6fbd20af855 64778-1233 HUMAN PRESCRIPTION DRUG DentiCare Pro-Gel Sodium Fluoride GEL DENTAL 19991103 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .02 g/mL E 20171231 64778-1371_93fca716-8acf-4403-a674-76729d45135a 64778-1371 HUMAN PRESCRIPTION DRUG DentiCare Pro-Foam Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/g E 20171231 64778-1372_49a40936-2fe8-4510-93e2-c22f1c04daea 64778-1372 HUMAN PRESCRIPTION DRUG DentiCare Pro-Foam Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .0272 g/g E 20171231 64778-1373_a24a83eb-3f91-496a-b78a-95b5a0b3db76 64778-1373 HUMAN PRESCRIPTION DRUG Denti-Care Topical Fluoride Foam Bubble Gum Fluoride Ions AEROSOL, FOAM DENTAL 20110209 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE; HYDROFLUORIC ACID .0176; .01 g/g; g/g E 20171231 64778-1375_ab845c6e-6c51-46fa-914a-4f2420863f53 64778-1375 HUMAN PRESCRIPTION DRUG Denti-Care Topical Fluoride Foam Grape Fluoride Ions AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE; HYDROFLUORIC ACID .0176; .01 g/g; g/g E 20171231 64778-1377_caee8eb8-3571-4e9f-80cc-2efdec2ad091 64778-1377 HUMAN PRESCRIPTION DRUG Denti-Care Topical Fluoride Foam Orange Fluoride Ions AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE; HYDROFLUORIC ACID .0176; .01 g/g; g/g E 20171231 64778-1378_0ef082fc-d68a-432b-adbf-dc67a578f3ad 64778-1378 HUMAN PRESCRIPTION DRUG Denti-Care Topical Fluoride Foam Raspberry Fluoride Ions AEROSOL, FOAM DENTAL 20110209 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE; HYDROFLUORIC ACID .0176; .01 g/g; g/g E 20171231 64778-1379_3a3abc74-46e5-46d2-8d17-f47284902078 64778-1379 HUMAN PRESCRIPTION DRUG Denti-Care Topical Sodium Fluoride Strawberry Sodium Fluoride AEROSOL, FOAM DENTAL 20030501 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE; HYDROFLUORIC ACID .0176; .01 g/g; g/g E 20171231 64778-1443_094d714e-d8f2-4622-87d0-d23b1671c703 64778-1443 HUMAN PRESCRIPTION DRUG DentiCare Pro-Rinse Sodium Fluoride RINSE DENTAL 20010601 UNAPPROVED DRUG OTHER AR Medicom Inc SODIUM FLUORIDE .02 g/mL E 20171231 64792-0001_396b2ae4-077f-4b81-ab90-47e21788a8f7 64792-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19991109 UNAPPROVED MEDICAL GAS Home Health Resource OXYGEN 995 mL/L E 20171231 64809-100_fbc0541f-5b16-440e-b149-a9e277f60826 64809-100 HUMAN OTC DRUG Sperian Eyesaline Emergency Eyewash Purified water LIQUID OPHTHALMIC 20110906 OTC MONOGRAPH FINAL part349 Sperian Eye & Face Protection Inc WATER 98.6 mL/100mL E 20171231 64809-101_9ed6165e-5e85-4320-8dcb-5d6798a4283d 64809-101 HUMAN OTC DRUG Sperian Eyesaline Eyewash Water LIQUID OPHTHALMIC 20110907 OTC MONOGRAPH FINAL part349 Sperian Eye & Face Protection Inc WATER 99.8 mL/100mL N 20181231 64809-104_b17e819f-af64-4de7-9fd9-7a7ed703ebd2 64809-104 HUMAN OTC DRUG Eyesaline Concentrate Water LIQUID OPHTHALMIC 20110908 OTC MONOGRAPH FINAL part349 Sperian Eye & Face Protection Inc. WATER 92.2 mL/100mL E 20171231 64809-105_eff94695-403e-4669-9bd1-f2cb05ec9b31 64809-105 HUMAN OTC DRUG Water Additive Purified Water LIQUID OPHTHALMIC 20120201 OTC MONOGRAPH FINAL part349 Sperian Eye & Face Protection Inc WATER 99 mL/100mL E 20171231 64811-315_425df869-79f6-481b-e054-00144ff88e88 64811-315 HUMAN PRESCRIPTION DRUG Triferic FERRIC PYROPHOSPHATE CITRATE POWDER PARENTERAL 20161128 NDA NDA208551 Ropack Inc. FERRIC PYROPHOSPHATE CITRATE 272 mg/272mg Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 64812-013_64431eff-e7a1-2a22-e053-2991aa0aecf9 64812-013 HUMAN OTC DRUG Vinoperfect Radiance Moisturizer Broad Spectrum SPF20 Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20150402 20180228 OTC MONOGRAPH NOT FINAL part352 Intercosmetiques AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 39.96; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 64841-773_c6309c8b-59c7-4d4c-b056-bc300786313e 64841-773 HUMAN OTC DRUG Med Plus ALCOHOL AEROSOL, FOAM TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part333 Handi-Clean Products, Inc. ALCOHOL 620 mg/g E 20171231 64842-1020_89fdcc48-8005-487d-828d-93d9ecb94f76 64842-1020 HUMAN PRESCRIPTION DRUG LONSURF trifluridine and tipiracil TABLET, FILM COATED ORAL 20150922 NDA NDA207981 Taiho Pharmaceutical Co., Ltd. TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE 20; 8.19 mg/1; mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC],Nucleoside Metabolic Inhibitor [EPC],Nucleic Acid Synthesis Inhibitors [MoA],Thymidine Phosphorylase Inhibitor [EPC],Thymidine Phosphorylase Inhibitors [MoA] N 20181231 64842-1025_89fdcc48-8005-487d-828d-93d9ecb94f76 64842-1025 HUMAN PRESCRIPTION DRUG LONSURF trifluridine and tipiracil TABLET, FILM COATED ORAL 20150922 NDA NDA207981 Taiho Pharmaceutical Co., Ltd. TRIFLURIDINE; TIPIRACIL HYDROCHLORIDE 15; 6.14 mg/1; mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC],Nucleoside Metabolic Inhibitor [EPC],Nucleic Acid Synthesis Inhibitors [MoA],Thymidine Phosphorylase Inhibitor [EPC],Thymidine Phosphorylase Inhibitors [MoA] N 20181231 64850-440_42ecacde-6859-47c6-ba44-13fb4f3b5448 64850-440 HUMAN PRESCRIPTION DRUG PHENDIMETRAZINE TARTRATE Phendimetrazine Tartrate TABLET ORAL 20121120 ANDA ANDA040762 Elite Laboratories, Inc PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 64850-810_7a9746d5-c8fc-41fe-af97-1ba440bfe575 64850-810 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20140501 ANDA ANDA040190 Elite Laboratories, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 64850-900_6e5cd1c8-b00c-484b-9a98-8f68aa19e729 64850-900 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20180115 ANDA ANDA203600 Elite Laboratories, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20191231 64854-012_0df8d5b5-7d82-41d3-a9f0-537e7450f9e0 64854-012 HUMAN OTC DRUG BreathRx with Zytex Cetylpyridinium Chloride SPRAY ORAL 20060721 OTC MONOGRAPH NOT FINAL part356 Discus Dental, LLC CETYLPYRIDINIUM CHLORIDE .85 mg/mL N 20191231 64854-014_05290491-2a97-4af6-99f6-1578dd92fc5d 64854-014 HUMAN OTC DRUG BreathRx with Zytex Cetylpyridinium Chloride RINSE ORAL 20060721 OTC MONOGRAPH NOT FINAL part356 Discus Dental, LLC CETYLPYRIDINIUM CHLORIDE .825 mg/mL N 20191231 64854-014_6db79777-af72-4c58-b4f7-eed0eae35fd6 64854-014 HUMAN OTC DRUG BreathRx with Zytex Cetylpyridinium Chloride RINSE ORAL 20060721 OTC MONOGRAPH NOT FINAL part356 Discus Dental, LLC CETYLPYRIDINIUM CHLORIDE .825 mg/mL N 20191231 64854-014_861b5c1d-58d3-444d-bf6c-7e0cb7d85bfd 64854-014 HUMAN OTC DRUG BreathRx with Zytex Cetylpyridinium Chloride RINSE ORAL 20060721 OTC MONOGRAPH NOT FINAL part356 Discus Dental, LLC CETYLPYRIDINIUM CHLORIDE .825 mg/mL N 20191231 64854-014_bd59b60d-0847-4f15-b822-1918c9ec22a3 64854-014 HUMAN OTC DRUG BreathRx with Zytex Cetylpyridinium Chloride RINSE ORAL 20060721 OTC MONOGRAPH NOT FINAL part356 Discus Dental, LLC CETYLPYRIDINIUM CHLORIDE .825 mg/mL N 20191231 64854-018_8d01076c-bdcb-46c0-8d43-56b1ecf54826 64854-018 HUMAN OTC DRUG BreathRx with Zytex SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20051121 OTC MONOGRAPH FINAL part355 Discus Dental, LLC SODIUM FLUORIDE 243 mg/g N 20191231 64854-018_95ec22ec-8e44-4859-a490-2c3b94683494 64854-018 HUMAN OTC DRUG BreathRx with Zytex SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20051121 OTC MONOGRAPH FINAL part355 Discus Dental, LLC SODIUM FLUORIDE 243 mg/g N 20191231 64854-018_b9282b09-b6b6-484a-afdc-326b4280e04c 64854-018 HUMAN OTC DRUG BreathRx with Zytex SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20051121 OTC MONOGRAPH FINAL part355 Discus Dental, LLC SODIUM FLUORIDE 243 mg/g N 20191231 64861-303_5b97f373-690c-4a84-b3f6-24353f50f771 64861-303 HUMAN OTC DRUG Omeprazole Delayed Release Omeprazole TABLET, DELAYED RELEASE ORAL 20080301 NDA NDA022032 Dexcel Ltd. OMEPRAZOLE 20 mg/1 N 20181231 64889-0001_cef73f07-0583-49c9-b68c-9bcded1b216e 64889-0001 HUMAN PRESCRIPTION DRUG Oxygen 64889-0001 Oxygen GAS RESPIRATORY (INHALATION) 20130325 UNAPPROVED MEDICAL GAS Advanced Oxy-Med Services Inc OXYGEN 99 L/100L E 20171231 64893-001_65bf29b4-94e2-4922-88eb-93687f70594b 64893-001 HUMAN OTC DRUG Binaca Anticavity Flouride Peppermint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100504 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 64893-030_e3614f3e-9eb6-480b-b948-73f102f18331 64893-030 HUMAN OTC DRUG Infectiguard Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20120627 OTC MONOGRAPH NOT FINAL part333E Dr. Fresh, Inc. ALCOHOL 62 mL/100mL E 20171231 64893-100_613a2b8a-2b50-4691-be5b-e2d595daa72d 64893-100 HUMAN OTC DRUG Infectiguard Fast Acting Antiseptic Hand Sanitizer ALCOHOL GEL TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Dr. Fresh, Inc. ALCOHOL 62 mL/100mL E 20171231 64893-200_98d9d0b5-431b-4690-8cac-d6df2af0c5fb 64893-200 HUMAN OTC DRUG infectiguard Fast Acting Antiseptic Hand Sanitizer with Moisturizer ALCOHOL GEL TOPICAL 20091230 OTC MONOGRAPH NOT FINAL part333 Dr. Fresh, Inc. ALCOHOL 62 mL/100mL E 20171231 64893-210_1545b5f0-3f3e-4146-ad51-2e5446461657 64893-210 HUMAN OTC DRUG DR. Fresh Dailies Travel SODIUM FLUORIDE PASTE DENTAL 20100716 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g E 20171231 64893-300_f3bbe7b8-e294-460c-8dbb-7f9a6f1adb7f 64893-300 HUMAN OTC DRUG Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse SODIUM FLUORIDE LIQUID DENTAL 20100902 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .05 mL/100mL E 20171231 64893-310_e0544c72-f88a-48a4-addb-c78237a5daf1 64893-310 HUMAN OTC DRUG Hello Kitty SODIUM FLUORIDE PASTE DENTAL 20110620 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g E 20171231 64893-320_677ebe7e-c802-45de-bc8e-ebc014c047b5 64893-320 HUMAN OTC DRUG Dr. Fresh Oral Care SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100504 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 64893-331_5b3cad98-ec6d-4f18-8c42-16accf2caefb 64893-331 HUMAN OTC DRUG Spider Sense Spider-Man Pediatric SODIUM FLUORIDE PASTE DENTAL 20110621 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g E 20171231 64893-365_908674e1-b3fe-4e62-83b0-a2aa9ad55fbe 64893-365 HUMAN OTC DRUG Firefly Angry Birds Fluoride SODIUM FLUORIDE AEROSOL, FOAM DENTAL 20120529 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 mL/100mL E 20171231 64893-383_8208d780-6bc5-43fc-963d-0272b25e4c77 64893-383 HUMAN OTC DRUG Baby SensiGel BENZOCAINE GEL TOPICAL 20111012 OTC MONOGRAPH NOT FINAL part356 Dr. Fresh, Inc BENZOCAINE 7.5 g/100g E 20171231 64893-384_e3823561-828e-4e77-896d-60f1d682233f 64893-384 HUMAN OTC DRUG Baby SensiGel Night Time Formula BENZOCAINE GEL TOPICAL 20111007 OTC MONOGRAPH NOT FINAL part356 Dr. Fresh, Inc BENZOCAINE 10 g/100g E 20171231 64893-385_7aea4dad-2c01-42d3-bb43-53a9697591ab 64893-385 HUMAN OTC DRUG SensiGel BENZOCAINE GEL TOPICAL 20110926 OTC MONOGRAPH NOT FINAL part356 Dr. Fresh, Inc. BENZOCAINE 20 g/100g E 20171231 64893-400_bc8e0d2d-1e5c-45c9-ad58-1a57a509dd7c 64893-400 HUMAN OTC DRUG FIREFLY AntiCavity Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20100603 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 64893-413_e537ba29-d109-47ee-9747-ae43358f0002 64893-413 HUMAN OTC DRUG Dr. Fresh Travel Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM MONOFLUOROPHOSPHATE 76 g/100g E 20171231 64893-440_cd7549c0-4481-4252-9707-06cc02588e39 64893-440 HUMAN OTC DRUG SmileGuard Strawberry Shortcake Bubblegum SODIUM FLUORIDE MOUTHWASH ORAL 20111209 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .05 mL/100mL E 20171231 64893-441_5fc87f98-ceab-412e-aeb4-9f2d6043eb87 64893-441 HUMAN OTC DRUG SmileGuard Spider Sense Spider-Man Bubblegum SODIUM FLUORIDE MOUTHWASH ORAL 20111209 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .05 mL/100mL E 20171231 64893-481_97ac81d4-ce20-4a91-9b4e-6b626f9bb5bf 64893-481 HUMAN OTC DRUG Dr. Fresh Brush and Cover SODIUM FLUORIDE PASTE DENTAL 20110620 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g E 20171231 64893-495_b798d802-1b11-4017-b7de-8631d2863951 64893-495 HUMAN OTC DRUG Smiley Gripper SODIUM FLUORIDE PASTE DENTAL 20110620 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g E 20171231 64893-500_c8657a43-fdb6-4e90-a4f7-edbfc7804663 64893-500 HUMAN OTC DRUG Binaca Fluoride Anticavity Mouthwash SODIUM FLUORIDE LIQUID DENTAL 20100902 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .05 mL/100mL E 20171231 64893-613_c8627830-7cd2-4597-a736-c08bbd3e5603 64893-613 HUMAN OTC DRUG FireFly SmileGuard Kids SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20110621 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 64893-700_178cc525-b119-4fff-ab40-27fac7600bda 64893-700 HUMAN OTC DRUG The Amazing SPIDER-MAN Hand Sanitizer Moisturizing With Vitamin E and Aloe ALCOHOL GEL TOPICAL 20101020 OTC MONOGRAPH NOT FINAL part333E Dr. Fresh, Inc. ALCOHOL 62 mL/100mL E 20171231 64893-800_11fccd57-e168-4851-8981-3d573315526b 64893-800 HUMAN OTC DRUG SmileGuard Just 4 Me SODIUM FLUORIDE PASTE DENTAL 20110817 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g E 20171231 64893-801_d9392825-e706-4563-81a8-0dca68ea5c97 64893-801 HUMAN OTC DRUG DR.Fresh Kids Pediatric SODIUM FLUORIDE PASTE DENTAL 20110817 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .243 g/100g E 20171231 64893-802_8cbddfdb-d9f4-4d4a-b3e4-121e48c5adba 64893-802 HUMAN OTC DRUG FIREFLY Pediatric SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20110817 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 64893-901_8ca562c2-d24e-437f-9bcc-33a2b301fb78 64893-901 HUMAN OTC DRUG Barbie Striped Fluoride SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20120613 OTC MONOGRAPH FINAL part355 Dr. Fresh, Inc. SODIUM FLUORIDE .22 g/100g E 20171231 64893-902_517a0531-f5eb-4efd-a7a2-7da3bd1eea42 64893-902 HUMAN OTC DRUG FIREFLY Barbie Fluoride Foam Bubblegum Flavor SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130301 OTC MONOGRAPH FINAL part355 Dr. Fresh LLC SODIUM FLUORIDE 2.43 mg/mL E 20171231 64893-903_0d6abf8e-42b5-413f-a466-f3212cd5daf7 64893-903 HUMAN OTC DRUG FIREFLY MARVEL Ultimate SPIDER-MAN Fluoride Foam Bubblegum Flavor SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130301 OTC MONOGRAPH FINAL part355 Dr. Fresh LLC SODIUM FLUORIDE 2.43 mg/mL E 20171231 64896-661_421a9b9d-1ed8-41bc-840e-3c5926d932ee 64896-661 HUMAN PRESCRIPTION DRUG RYTARY Levodopa and Carbidopa CAPSULE, EXTENDED RELEASE ORAL 20150112 NDA NDA203312 Impax Specialty Pharma LEVODOPA; CARBIDOPA 95; 23.75 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 64896-662_421a9b9d-1ed8-41bc-840e-3c5926d932ee 64896-662 HUMAN PRESCRIPTION DRUG RYTARY Levodopa and Carbidopa CAPSULE, EXTENDED RELEASE ORAL 20150112 NDA NDA203312 Impax Specialty Pharma LEVODOPA; CARBIDOPA 145; 36.25 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 64896-663_421a9b9d-1ed8-41bc-840e-3c5926d932ee 64896-663 HUMAN PRESCRIPTION DRUG RYTARY Levodopa and Carbidopa CAPSULE, EXTENDED RELEASE ORAL 20150112 NDA NDA203312 Impax Specialty Pharma LEVODOPA; CARBIDOPA 195; 48.75 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 64896-664_421a9b9d-1ed8-41bc-840e-3c5926d932ee 64896-664 HUMAN PRESCRIPTION DRUG RYTARY Levodopa and Carbidopa CAPSULE, EXTENDED RELEASE ORAL 20150112 NDA NDA203312 Impax Specialty Pharma LEVODOPA; CARBIDOPA 245; 61.25 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 64896-669_093a08a9-ea81-492a-85ff-d019f274ecaf 64896-669 HUMAN PRESCRIPTION DRUG EMVERM mebendazole TABLET, CHEWABLE ORAL 20160215 ANDA ANDA073580 Impax Specialty Pharma MEBENDAZOLE 100 mg/1 Antihelminthic [EPC] N 20181231 64896-671_b80a9a63-d4f2-44ee-b0ac-be09815f2294 64896-671 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan TABLET ORAL 20120402 NDA NDA020768 Impax Specialty Pharma ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 64896-672_b80a9a63-d4f2-44ee-b0ac-be09815f2294 64896-672 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan TABLET ORAL 20120402 NDA NDA020768 Impax Specialty Pharma ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 64896-681_85859f91-e726-40e2-9846-1b45841aa29c 64896-681 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan SPRAY, METERED NASAL 20120702 NDA NDA021450 Impax Specialty Pharma ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 64896-682_85859f91-e726-40e2-9846-1b45841aa29c 64896-682 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan SPRAY, METERED NASAL 20131206 NDA NDA021450 Impax Specialty Pharma ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 64896-691_b80a9a63-d4f2-44ee-b0ac-be09815f2294 64896-691 HUMAN PRESCRIPTION DRUG ZOMIG ZMT Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20120702 NDA NDA021231 Impax Specialty Pharma ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 64896-692_b80a9a63-d4f2-44ee-b0ac-be09815f2294 64896-692 HUMAN PRESCRIPTION DRUG ZOMIG ZMT Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20120702 NDA NDA021231 Impax Specialty Pharma ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 64896-693_be2785c8-895b-431b-89af-4cbdeb9a9972 64896-693 HUMAN PRESCRIPTION DRUG ALBENZA albendazole TABLET, FILM COATED ORAL 19960611 NDA NDA020666 Impax Specialty Pharma ALBENDAZOLE 200 mg/1 Antihelminthic [EPC],Cytochrome P450 1A Inducers [MoA] N 20191231 64920-0001_0a1a1032-6a50-484e-b5dc-82e68aab7738 64920-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990426 UNAPPROVED MEDICAL GAS WHABA Medical, Inc. OXYGEN 99 L/100L E 20171231 64922-233_2f0fff95-a428-49f9-b2ef-3c854dbc1acc 64922-233 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19900101 NDA NDA205767 ADF Welding & Medical, Inc. OXYGEN 99 L/100L N 20191231 64922-240_95babba7-0817-4f1b-9278-2f68afde10d9 64922-240 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 19900101 NDA NDA205766 ADF Welding & Medical, Inc. NITROGEN 99 L/100L N 20191231 64932-1234_eba75f5d-d580-4812-be0a-407deac2e19a 64932-1234 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19770101 UNAPPROVED MEDICAL GAS Cape Medical Supply, Inc OXYGEN 99 L/100L N 20181231 64942-0001_1a7a4065-c39c-44ca-8463-ee711b515fe3 64942-0001 HUMAN OTC DRUG Degree Women Nature Effects Orange Flower and Cranberry Antiperspirant and Deodorant STICK TOPICAL 20090901 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0016_698dd490-cca8-4a28-aea6-d115790af9ed 64942-0016 HUMAN OTC DRUG Vaseline Pure Baby Petrolatum JELLY TOPICAL 20100318 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 99.96 g/100g N 20181231 64942-0034_8d92dc88-ce59-4b8c-ac18-875053d7bbe1 64942-0034 HUMAN OTC DRUG Vaseline Pure Petrolatum JELLY TOPICAL 20100318 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 100 g/100g N 20181231 64942-0053_c22f300e-1305-4642-8472-087d5c67fc21 64942-0053 HUMAN OTC DRUG Vaseline Lip Therapy Advanced Formula Petrolatum OINTMENT TOPICAL 20040120 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 100 g/100g N 20181231 64942-0054_c5a028f5-1826-4b80-acaf-58e7a88f8a10 64942-0054 HUMAN OTC DRUG Vaseline Lip Therapy Cherry Petrolatum OINTMENT TOPICAL 20040120 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 100 g/100g N 20181231 64942-0276_30c51f56-ed41-4057-8874-5279abe70ec5 64942-0276 HUMAN OTC DRUG Vaseline Petroleum Jelly Deep Moisture Petroleum CREAM TOPICAL 20071231 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 30 g/100g E 20171231 64942-0634_bbcf52db-6251-4766-8589-943b9fc5966e 64942-0634 HUMAN OTC DRUG Degree for Men Extreme Blast Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0675_d23783ca-00c7-4b64-a417-c42e594ad7c4 64942-0675 HUMAN OTC DRUG Degree for Men Sport Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0689_541443a5-3ac6-4f06-9800-f316500940be 64942-0689 HUMAN OTC DRUG Axe Kilo Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100113 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0690_c1889727-4fdc-47e1-9d05-d904230256bc 64942-0690 HUMAN OTC DRUG Axe Essence Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090324 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0731_d04264c4-8967-48a3-8a33-3e77a30284a4 64942-0731 HUMAN OTC DRUG Axe Touch Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090324 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0747_cec9104e-7abe-40ba-80dc-f00f90da1cbd 64942-0747 HUMAN OTC DRUG Suave Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090428 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.5 g/100g N 20181231 64942-0774_f23351a1-7763-4cc6-b911-cfe662cc16be 64942-0774 HUMAN OTC DRUG Suave Fresh Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-0775_69a191f9-e120-4ab3-a3a0-ea2294cbccec 64942-0775 HUMAN OTC DRUG Suave Powder Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-0779_00090a78-f4df-47a0-aba4-fb30414aedb5 64942-0779 HUMAN OTC DRUG Degree UltraClear Pure Satin Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090428 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-0782_70b6158d-d36a-427a-92fe-f78f6eeebbf1 64942-0782 HUMAN OTC DRUG Degree Women UltraClear Pure Rain Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-0786_a8b62496-b537-4e3c-b22f-c1eca23ceb55 64942-0786 HUMAN OTC DRUG Degree for Men Cool Comfort Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0810_368245ea-dac5-4543-9271-d23a3927e1fb 64942-0810 HUMAN OTC DRUG Axe Clix Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0819_811f9139-cedb-4a25-9da3-e44bf2112626 64942-0819 HUMAN OTC DRUG Degree for Men Power Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0824_2f2c60d2-98a6-434e-a300-2a86af8fc846 64942-0824 HUMAN OTC DRUG Degree UltraClear Pure Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100108 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-0831_1173f14d-b0b7-4dbb-93e7-c0dbfa68fc40 64942-0831 HUMAN OTC DRUG Degree Fresh Oxygen Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090428 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0832_286e661f-d44a-4874-bf81-d516b52a7a7f 64942-0832 HUMAN OTC DRUG Degree Women Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0836_fb37de77-33f9-4d24-947e-dc31e602383e 64942-0836 HUMAN OTC DRUG Degree Women Shower Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0866_a3fbd2bf-bbf7-45a5-b998-877b6a04dbec 64942-0866 HUMAN OTC DRUG Degree for Men Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-0889_10d7fb09-5347-447a-8cff-d583cbac65b8 64942-0889 HUMAN OTC DRUG Dove Ultimate Go Fresh Cool Essentials Antiperspirant and Deodorant STICK TOPICAL 20091201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-0891_58bc974e-08c1-412c-ab3e-e527ef0fe9a9 64942-0891 HUMAN OTC DRUG Suave Pacific Breeze Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-0893_f1db4a00-7da2-4266-8918-1314a9ba2d8a 64942-0893 HUMAN OTC DRUG Suave Sweet Pea and Violet Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-0894_030e076c-d124-4ea5-bcea-ba6d62701a25 64942-0894 HUMAN OTC DRUG Suave Tropical Paradise Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-0902_d2785123-b187-4f69-8fde-4835dc8bbe46 64942-0902 HUMAN OTC DRUG Dove IS Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090414 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1007_cc573e9f-2768-487a-9e78-29d897f8ab84 64942-1007 HUMAN OTC DRUG Degree for Men Absolute Protection Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090428 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.5 g/100g N 20181231 64942-1010_fd3cc81c-641a-4e2e-a7a7-3a48ae1538bd 64942-1010 HUMAN OTC DRUG Dove Clinical Protection Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1013_ee115fc6-532d-4dc6-8c9e-683016bb1f8f 64942-1013 HUMAN OTC DRUG Degree Clinical Protection Shower Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1014_b90e316b-06ac-401d-b5d2-6d21de4cd7b9 64942-1014 HUMAN OTC DRUG Degree Clinical Protection Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1018_e8f2743f-a39e-465c-85f4-d1c26d63caa9 64942-1018 HUMAN OTC DRUG Dove IS Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20080305 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1022_428e4640-276c-49a4-ab81-36c0d13497cf 64942-1022 HUMAN OTC DRUG Dove IS Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20080305 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1031_31476bcc-21b6-471e-981d-5b8bf5516cbd 64942-1031 HUMAN OTC DRUG Axe Sharp Focus Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090203 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1035_f5036177-5219-4a5e-8d89-75c5c8db45b8 64942-1035 HUMAN OTC DRUG Degree Clinical Protection Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20091006 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1036_83261b15-a8cc-4b0f-adcf-64d5055b6ef8 64942-1036 HUMAN OTC DRUG Degree Clinical Protection Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090122 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1037_15d424f5-d2ad-4616-8fbb-713d7c15bf5f 64942-1037 HUMAN OTC DRUG Suave Clinical Protection Powder Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1038_69ad9419-ac48-494a-98be-db322f4d45db 64942-1038 HUMAN OTC DRUG Vaseline Intensive Rescue Clinical Therapy Fragrance Free DIMETHICONE LOTION TOPICAL 20080623 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever DIMETHICONE 1 g/100mL E 20171231 64942-1044_d3eede6a-8600-4dde-bf56-d9b61fe03daa 64942-1044 HUMAN OTC DRUG Degree Clinical Protection Classic Romance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20081029 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1048_72da477e-c8fa-4656-80e1-1a4234162cdc 64942-1048 HUMAN OTC DRUG Vaseline Intensive Care Aloe Fresh Protecting Body Lotion SPF 15 LOTION TOPICAL 20081223 OTC MONOGRAPH FINAL part352 Conopco Inc. d/b/a Unilever OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 3; 1 mL/100mL; mL/100mL; mL/100mL N 20181231 64942-1049_ca6289d2-41cd-41dd-a35a-f781cb8d77a9 64942-1049 HUMAN OTC DRUG Axe Armor AntiDandruff 2 in 1 Shampoo plus Conditioner SHAMPOO TOPICAL 20081223 OTC MONOGRAPH FINAL part358 Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL N 20181231 64942-1050_685c8edd-d2ab-4fe1-b164-24388941d276 64942-1050 HUMAN OTC DRUG Suave Men 2 in 1 Dandruff Shampoo plus Conditioner SHAMPOO TOPICAL 20090122 OTC MONOGRAPH FINAL part358 Conopco Inc. d/b/a Unilever PYRITHIONE ZINC .5 mL/100mL N 20181231 64942-1052_798e1ec0-8e6e-4704-9581-c4d64e72eca1 64942-1052 HUMAN OTC DRUG Dove Ultimate Go Fresh Refreshing Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1053_e06b0b50-eaf8-460f-b6c9-a7ea252503ec 64942-1053 HUMAN OTC DRUG Dove Ultimate Go Fresh Energizing Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1054_0d8b7eec-b3c2-41af-ae28-49e1898b64f4 64942-1054 HUMAN OTC DRUG Dove Ultimate Go Fresh Burst Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1059_dff08341-c945-40f4-8151-c9e9a562bc3d 64942-1059 HUMAN OTC DRUG Axe Instinct Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1060_e4b74821-220b-4ecc-8cf2-3e7c8cd1014f 64942-1060 HUMAN OTC DRUG Degree For Women Delicious Bliss Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1065_7e6e7da4-e59f-4b1a-a914-640ce3e069d3 64942-1065 HUMAN OTC DRUG Degree For Women Sexy Intrique Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1066_065866b2-a703-49ad-a3f9-9df86e296550 64942-1066 HUMAN OTC DRUG Degree For Women Classic Romance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1069_851d20c4-2207-4401-8c7a-6093c1dce221 64942-1069 HUMAN OTC DRUG Dove Ultimate Beauty Care Silk Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1071_9f8a1cce-1030-4a41-a155-0b310a69a779 64942-1071 HUMAN OTC DRUG Dove Ultimate Beauty Care Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1073_f27b7de7-9796-4392-86f0-ac5f9d609e05 64942-1073 HUMAN OTC DRUG Dove Clinical Protection Cool Energizing Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1074_c06aea0a-e4cf-4a57-8a4a-4827b20c2a9d 64942-1074 HUMAN OTC DRUG Dove Clinical Protection Visibly Smooth Wild Rose Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1077_5d612890-30cb-41b2-80ad-bbab7fa940ad 64942-1077 HUMAN OTC DRUG Suave Men Sport Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090402 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1086_6da6efa7-9246-4140-9364-e9d4f18a1b2e 64942-1086 HUMAN OTC DRUG Axe Dark Temptation Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1087_885f4e11-2480-4a89-8ee2-fc8cfcb357d1 64942-1087 HUMAN OTC DRUG Dove Ultimate Beauty Care Smooth Cashmere Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1088_7e1e5c0d-883e-4bd6-b121-8de033177ada 64942-1088 HUMAN OTC DRUG Dove Ultimate Visibly Smooth Nature Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100118 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1089_eeb8dfff-6049-410c-90b1-ef3886cf174d 64942-1089 HUMAN OTC DRUG Degree Girl Just Dance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1090_b2b1d1fa-2ab2-4763-94cb-eb095c619274 64942-1090 HUMAN OTC DRUG Dove Ultimate Sensitive Care Fragrance Free Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1093_b6d6a71d-452c-46b5-84ce-469502bb0343 64942-1093 HUMAN OTC DRUG Degree for Men Absolute Protection V12 Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM 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STICK TOPICAL 20090905 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1110_a326b44f-a797-46ce-a7d4-1e38011a5ea0 64942-1110 HUMAN OTC DRUG Degree Ultraclear Red Satin AP and Deo STICK TOPICAL 20091215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1111_82ce1b23-74ff-4bd8-8da0-7fd5d1566212 64942-1111 HUMAN OTC DRUG Degree Women Clinical Protection Sexy Intrigue Invisible Stick Antiperspirant and Deodorant STICK TOPICAL 20091215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1112_8f8e2d87-f184-44bb-8213-9507aac85c0e 64942-1112 HUMAN OTC DRUG Degree Men Clinical Protection Adventure Invisible Stick Antiperspirant and Deodorant STICK TOPICAL 20091006 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1113_2cfec917-ec03-45ad-b175-6835bb2faa55 64942-1113 HUMAN OTC DRUG Suave Fresh Aerosol Antiperspirant and Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g N 20181231 64942-1114_4dada618-49c7-48bf-8357-415726ae8a51 64942-1114 HUMAN OTC DRUG Suave Powder Aerosol Antiperspirant and Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g N 20181231 64942-1115_98692e5f-dbd1-4672-ad96-9f3d3ac714db 64942-1115 HUMAN OTC DRUG Degree Girl Friends Forever Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100106 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1116_ddacda39-3325-44fa-9dd4-bd7a08f0dc11 64942-1116 HUMAN OTC DRUG Axe Clinical Protection Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100111 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1117_fdd6c113-e899-426b-a854-63c39c346ef3 64942-1117 HUMAN OTC DRUG Dove Clinical Protection Cool Essentials Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1118_32f76433-aabe-4e4e-9aaa-c1fbb5346818 64942-1118 HUMAN OTC DRUG Degree Nature Effects Honeysuckle and Tea Tree Oil Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100106 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1119_7f620688-e295-4a74-9f58-1e36ea4bef13 64942-1119 HUMAN OTC DRUG Degree Nature Effects Orange Flower and Cranberry Antiperspirant and 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GLY STICK TOPICAL 20101006 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1124_cfd8df70-e9c7-46da-abf1-acbda8663ca4 64942-1124 HUMAN OTC DRUG Dove Men plus Care Unscented Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1125_9a962caa-c793-4ff3-9233-1d10f7697f4f 64942-1125 HUMAN OTC DRUG Degree Men Adventure Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100909 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.5 g/100g N 20181231 64942-1126_0082c034-35ae-4421-a56f-ef2b27dfbec0 64942-1126 HUMAN OTC DRUG Dove Ultimate Go Fresh Rebalance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1127_da39500e-2d35-4cf8-a83c-37e732c184d8 64942-1127 HUMAN OTC DRUG Dove Pearl Finish Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1128_e753c6f8-93a0-4c43-a073-72b1d56c5466 64942-1128 HUMAN OTC DRUG Dove Nourished Beauty Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1129_dd20d352-30a4-4a46-81ed-f07e9d769ef3 64942-1129 HUMAN OTC DRUG Dove Men plus Care Extra Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.8 g/100g N 20181231 64942-1130_4222188a-5bc8-4b24-8a05-300f92afcbc0 64942-1130 HUMAN OTC DRUG Suave Professionals Men AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20101208 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL N 20181231 64942-1131_bebe1da6-e40a-4d9b-9f0d-ab79ee7e406a 64942-1131 HUMAN OTC DRUG Axe Excite Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1132_15c3aa44-c378-439a-9d56-dea9e394982a 64942-1132 HUMAN OTC DRUG Degree Clinical Protection Fresh Energy Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1133_40bee267-7846-427f-abf0-0a3daff9e6c4 64942-1133 HUMAN OTC DRUG Degree Clinical Protection Active Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1134_fb22b07c-09ce-4955-a9f9-f19e6c258400 64942-1134 HUMAN OTC DRUG Degree Active Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1135_b4a58efd-b7e8-4059-aaef-0ccf7d8559e3 64942-1135 HUMAN OTC DRUG Degree Fresh Energy Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1136_5f2b7d74-63e4-470c-b17c-4d52c7b153b8 64942-1136 HUMAN OTC DRUG Degree Cotton Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1137_b2399b9e-bfad-458c-96e7-888a5624edc9 64942-1137 HUMAN OTC DRUG Degree White Flower Basil Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1138_6aaacf11-e98e-4e2d-b830-ca8827b7b09c 64942-1138 HUMAN OTC DRUG Suave Clinical Protection Wild Cherry Blossom Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101124 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1139_054bfddc-ca9e-4d5b-a957-8f76039bb7ce 64942-1139 HUMAN OTC DRUG Suave Powder Roll On Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY LIQUID TOPICAL 20101118 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 22 mL/100mL N 20181231 64942-1140_cf1742dd-5af8-463c-8173-33c08bacd5c3 64942-1140 HUMAN OTC DRUG Dove Clinical Protection Rebalance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101205 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1141_8c88acb7-e7f4-4e51-a741-fabfaf0537fa 64942-1141 HUMAN OTC DRUG Dove Clinical Protection Revive Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1142_1a98b5fb-14ab-4643-b286-8dfabad596b5 64942-1142 HUMAN OTC DRUG Suave IS Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101205 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1143_d00480fb-9d9c-47cd-a192-d17ade315789 64942-1143 HUMAN OTC DRUG Suave IS Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101205 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1144_1008dba3-1d42-4bae-b038-fdb4846a79bf 64942-1144 HUMAN OTC DRUG Suave IS Wild Cherry Blossom Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101205 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1145_ae879f47-463f-4069-910e-1a6717e51814 64942-1145 HUMAN OTC DRUG Suave IS Sweet Pea and Violet Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101205 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1146_604e5855-3767-44db-bfd6-5727861ce367 64942-1146 HUMAN OTC DRUG Suave IS Pacific Breeze Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101205 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1147_db05aa54-d504-4947-a13e-60ba6f0abaf0 64942-1147 HUMAN OTC DRUG Suave IS Tropical Paradise Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101205 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1148_67bf526d-5466-496b-a1dd-08eefb053603 64942-1148 HUMAN OTC DRUG Suave IS Men Sport Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101205 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1149_5359f300-41ad-44d9-8840-04e0ecc4ac5c 64942-1149 HUMAN OTC DRUG Degree Men Everest Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1150_bc81c1cc-3139-4950-aadb-999d63d10dab 64942-1150 HUMAN OTC DRUG Degree Sport Aerosol Antiperspirant and Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20101216 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g N 20181231 64942-1151_454d7d58-9953-456b-a8e8-b446804b575e 64942-1151 HUMAN OTC DRUG Degree Shower Clean Aerosol Antiperspirant and Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20101216 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g N 20181231 64942-1152_932a5e6c-3859-424a-acbd-c4d745c6c623 64942-1152 HUMAN OTC DRUG Axe Clix Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1153_f4d236fe-b167-4410-a8e2-12f941e41294 64942-1153 HUMAN OTC DRUG Axe Instinct Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20100101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1154_5229d6fc-a9e0-494b-86a4-7c9d4e3200eb 64942-1154 HUMAN OTC DRUG Degree Adrenaline Sport Defense Invisible Stick Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101222 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.5 g/100g N 20181231 64942-1155_26181efd-c76e-4275-b98b-7b51250a504e 64942-1155 HUMAN OTC DRUG Degree Girl Love Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 17.8 g/100g N 20181231 64942-1156_9b017533-5663-4ba8-acca-c86956b4c061 64942-1156 HUMAN OTC DRUG Degree Girl Just Dance Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110209 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1157_ecc8cf45-63ea-4aa7-9efb-75b378c1bc90 64942-1157 HUMAN OTC DRUG Degree Girl Friends Forever Invisible Solid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110209 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1158_fac83990-931b-43e7-b749-078d26481768 64942-1158 HUMAN OTC DRUG Degree Clinical Protection Motion Sense Classic Romance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1159_04784ca5-cd6e-42bd-b187-6b5447e27f31 64942-1159 HUMAN OTC DRUG Degree Clinical Protection Motion Sense Sexy Intrigue Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110501 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1160_23a601b3-921a-4b30-a72d-aa2d7729cbfc 64942-1160 HUMAN OTC DRUG Degree Clinical Protection Motion Sense Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110324 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1161_a6ef22e5-8ba4-4adb-b58b-cb4350940de1 64942-1161 HUMAN OTC DRUG Axe Crew Cut Buzzed Look with Sunscreen SPF 15 OCTINOXATE, OXYBENZONE, OCTISALATE CREAM TOPICAL 20101208 OTC MONOGRAPH NOT FINAL part352 CONOPCO Inc. d/b/a Unilever OCTINOXATE; OXYBENZONE; OCTISALATE 7; 3; 1 g/100g; g/100g; g/100g N 20181231 64942-1163_4d87842f-f4aa-46a9-a574-ea527e2c7e96 64942-1163 HUMAN OTC DRUG Dove Men Clinical Protection Clean Comfort Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1164_dc8a40eb-c1b9-43f7-8fa3-77e7e4bc777a 64942-1164 HUMAN OTC DRUG Axe Dry Phoenix Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1165_4d5a694e-d925-4f5f-af94-f19e22b1bf4f 64942-1165 HUMAN OTC DRUG Axe Dry Dark Temptation Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1166_9262d7e8-317a-48c1-8fce-592509623d27 64942-1166 HUMAN OTC DRUG Axe Dry Twist Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1167_16caeebe-08b1-49e1-b87d-eabc7cf7a9c5 64942-1167 HUMAN OTC DRUG Axe Dry Excite Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1168_666abf36-4357-455c-93a0-650503606a13 64942-1168 HUMAN OTC DRUG Axe Dry Sharp Focus Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1169_189f99b0-536a-4d80-b8e1-7f942b258e29 64942-1169 HUMAN OTC DRUG Axe Dry Essence Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1170_12a67b18-aaee-4fc7-bbbc-6ee6d327f593 64942-1170 HUMAN OTC DRUG Axe Dry Kilo Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1171_628ddab0-8011-4ab0-bdab-b7f20fc1c42a 64942-1171 HUMAN OTC DRUG Axe Dry Clix Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1172_e8c68e83-62c6-494a-bf40-0af2ff806143 64942-1172 HUMAN OTC DRUG Degree Red Satin Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1173_0d54b1c4-b3f0-406f-a9cd-6c9013e87d75 64942-1173 HUMAN OTC DRUG Degree Pure Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1174_ce1651e1-8230-42e7-9c6d-833313288305 64942-1174 HUMAN OTC DRUG Degree Pure Rain Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1175_4d2b4f99-47c5-465a-885c-dad4be47d2c1 64942-1175 HUMAN OTC DRUG Degree Classic Romance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1176_e0a3ae8a-5c91-43fd-86e9-38975dca9b29 64942-1176 HUMAN OTC DRUG Degree Sexy Intrigue Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1177_f57746e7-b4f0-480b-91d4-1f6cb5c23080 64942-1177 HUMAN OTC DRUG Degree Orange Flower and Cranberry Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1178_8620b565-bc74-4683-90d6-fec82979d519 64942-1178 HUMAN OTC DRUG Degree Honeysuckle and Tea Tree Oil Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1179_0b3e3df6-081e-42a5-9465-f7ed7bd46e1a 64942-1179 HUMAN OTC DRUG Degree Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1180_53758b3e-d246-40b0-b7bf-83240b99423a 64942-1180 HUMAN OTC DRUG Degree Sport Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1181_2b5bd4df-bc84-4708-9878-769a0e80703b 64942-1181 HUMAN OTC DRUG Degree Extreme Blast Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1182_1f1800ce-e8d6-4e61-a334-2968308b9a89 64942-1182 HUMAN OTC DRUG Degree Power Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110601 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1183_16eac702-9645-40c7-93de-a278eef867a9 64942-1183 HUMAN OTC DRUG Degree Cool Comfort Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1184_6b8595a0-c194-420a-af87-8282f4a9f384 64942-1184 HUMAN OTC DRUG Degree Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1185_8eaeaeac-b058-428b-abb6-4ad1f01ed950 64942-1185 HUMAN OTC DRUG Axe Freeze AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20090802 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL N 20181231 64942-1186_a3aa1f6b-c21d-478b-93c1-f4df94b02c0f 64942-1186 HUMAN OTC DRUG Axe Armor AntiDandruff 2 in 1 Pyrithione Zinc SHAMPOO TOPICAL 20081223 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL N 20181231 64942-1187_7a6eafc0-2d69-4780-8dc6-95adc56909a1 64942-1187 HUMAN OTC DRUG Degree Men Clinical Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110623 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1188_ddd7941c-02fa-4322-af12-0529eadd0638 64942-1188 HUMAN OTC DRUG Degree Men Clinical Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110623 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1189_50d96f77-3175-4d2c-93a7-e5c32fab5660 64942-1189 HUMAN OTC DRUG Degree Clinical Adventure Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110623 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1190_d34e43e6-8cf8-44dc-a4fe-04cc709dcbaa 64942-1190 HUMAN OTC DRUG Vaseline Total Moisture Aloe Fresh SPF 15 OCTISALATE, AVOBENZONE, ENSULIZOLE LOTION TOPICAL 20120801 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever OCTISALATE; AVOBENZONE; ENSULIZOLE; OCTOCRYLENE 50; 20; 15; 13 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 64942-1191_23363104-38f5-4097-8891-dc6e00c703d0 64942-1191 HUMAN OTC DRUG Degree Shower Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110810 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1192_63ccf1a6-cf8f-403d-98ef-4c07505d22fe 64942-1192 HUMAN OTC DRUG Degree Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110810 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1193_a1d9b9d3-9327-457f-b35f-33d4189f3110 64942-1193 HUMAN OTC DRUG Degree Love Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110810 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1194_4c380459-df30-4038-8762-36878db8e90e 64942-1194 HUMAN OTC DRUG Degree V12 Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1195_913d2c56-ebcb-4acd-b456-012e71e43643 64942-1195 HUMAN OTC DRUG Suave Cocoa Butter Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20111005 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-1196_9fd80ca3-4af0-494c-82f5-9b051e4c3c33 64942-1196 HUMAN OTC DRUG Axe Dry Anarchy Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1197_4ae15e0f-9980-43b4-a5fd-70708661ff8a 64942-1197 HUMAN OTC DRUG Degree Sport Defense Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1198_cbac03b4-8eb3-40b5-8445-6449c02febcd 64942-1198 HUMAN OTC DRUG Degree Adventure Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1199_49955602-9dbc-4ab5-bf23-17e0dd198038 64942-1199 HUMAN OTC DRUG Degree Extreme Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1200_511ef2eb-08bb-48b4-996d-7e6f48063724 64942-1200 HUMAN OTC DRUG Degree Clinical Protection Motion Sense Cotton Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1201_850b5dd4-907c-4cc5-83ff-f198fcab73a3 64942-1201 HUMAN OTC DRUG Degree Clinical Men Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1202_4e1db4ae-a641-4438-bec7-97800960d033 64942-1202 HUMAN OTC DRUG Degree Clinical Men Sport Strength Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1203_e4172868-b66c-49bf-aadb-29d3133dde7a 64942-1203 HUMAN OTC DRUG Degree Clinical Men Extreme Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1204_582f34dd-a29a-42fe-8a2b-55d85a6fa506 64942-1204 HUMAN OTC DRUG Dove Clinical Protection Cleartone Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110826 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1205_772935c8-ab9a-43df-9a7c-44260739d4e0 64942-1205 HUMAN OTC DRUG Suave Clinical Protection Everlasting Sunshine Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1206_719ec220-9e3d-4109-a92e-d2f1d7eb7868 64942-1206 HUMAN OTC DRUG Degree Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1207_712711b6-7968-49fc-a9e9-29aab2552544 64942-1207 HUMAN OTC DRUG Degree Motion Sense Linen Dry Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1208_80897e7f-9671-4cfc-b72c-79740058a968 64942-1208 HUMAN OTC DRUG Degree Clinical Protection Motion Sense Linen Dry Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1209_cf299595-b298-49d0-9608-a8913cc72451 64942-1209 HUMAN OTC DRUG Degree Nature Effects Absorbent Sea Salt Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1210_13614a58-4788-41f4-a8c0-7e4881ef8460 64942-1210 HUMAN OTC DRUG Dove Cleartone Skin Renew Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1211_6f2a7011-fdbb-46a5-a128-9d7ee8314cdb 64942-1211 HUMAN OTC DRUG Dove Men plus Care Aqua Impact Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1212_70c289e8-c590-4673-bc7e-a37771851f2f 64942-1212 HUMAN OTC DRUG Dove Go Fresh Rebalance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1213_5db8396d-45d0-4172-88d0-5ba6c321ab5d 64942-1213 HUMAN OTC DRUG Dove Go Sleeveless Nourished Beauty Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1214_4a7c7b27-b503-4870-80fe-97e44482e0af 64942-1214 HUMAN OTC DRUG Dove Revive Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1215_2911fe70-a59d-4e5c-90e6-ff19e2e11dba 64942-1215 HUMAN OTC DRUG Dove Cool Essentials Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1216_146f12d0-b567-4f58-b436-2deb1f1bcdcd 64942-1216 HUMAN OTC DRUG Dove Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1217_4f03ac89-b572-41bd-be45-e6c97cbd6c90 64942-1217 HUMAN OTC DRUG Dove Go Sleeveless Fragrance Free Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111110 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1218_19f1fe39-0ffe-4314-868a-ac3c208a7281 64942-1218 HUMAN OTC DRUG Dove Clean Comfort Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111110 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1219_a96c533f-7485-4070-9896-7e998a5f3301 64942-1219 HUMAN OTC DRUG Dove Extra Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111110 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1220_e52ae062-eb2e-4064-a3ff-cb3551f8497d 64942-1220 HUMAN OTC DRUG Dove Radiant Silk Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111110 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1221_3a355d5c-7d48-49ae-95df-51a3af070fba 64942-1221 HUMAN OTC DRUG Dove Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111110 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1222_7d5d4c1d-2437-4ea3-9f42-e84dda38601b 64942-1222 HUMAN OTC DRUG Dove Clinical Protection Soothing Chamomile Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1223_9fcad333-7b2d-475c-ac05-a46da9e1b74a 64942-1223 HUMAN OTC DRUG Dove Cleartone Sheer Touch Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111230 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1224_2d3c05a3-f956-426a-8572-0dfc0c24e657 64942-1224 HUMAN OTC DRUG Dove Cleartone Pink Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120126 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1225_da006d17-5577-426d-a511-15b08bdf589c 64942-1225 HUMAN OTC DRUG Dove Go Sleeveless Soothing Chamomile Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1226_ea414494-3ae0-4538-b40a-23a43bf378c0 64942-1226 HUMAN OTC DRUG Dove Go Sleeveless Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20111231 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1227_9d359512-9113-453c-a61c-fe26ad08a258 64942-1227 HUMAN OTC DRUG Dove Go Sleeveless Beauty Finish Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1228_234a790d-2437-46ef-aa37-ac159e894f56 64942-1228 HUMAN OTC DRUG Dove Go Fresh Burst Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1229_a972c581-f565-4485-885b-c5a1f7203c9a 64942-1229 HUMAN OTC DRUG Dove Go Fresh Energizing Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1230_9a4dc425-9959-4c6d-997c-dd899d69e051 64942-1230 HUMAN OTC DRUG Dove Sensitive Skin Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120214 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1231_4988b7d6-6b29-4a85-937c-199333107848 64942-1231 HUMAN OTC DRUG Suave Everlasting Sunshine Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20111005 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-1232_8835527b-57c4-4703-9430-077ff2c9cf73 64942-1232 HUMAN OTC DRUG Degree Invisible Solid Fresh Oxygen Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20110810 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1233_087b9d19-85cc-4e66-bc4b-06b9e2a1f499 64942-1233 HUMAN OTC DRUG Suave Revitalizing Mint and Eucalyptus AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120101 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL N 20181231 64942-1234_5a3882c5-369a-424c-a09a-345206e8dfb5 64942-1234 HUMAN OTC DRUG Suave Invigorating Ocean Minerals and Aloe Vera AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120101 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL N 20181231 64942-1235_f3807af3-7d4f-4344-ae98-da28bd536e74 64942-1235 HUMAN OTC DRUG Suave Nourishing Coconut and Shea Butter AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120101 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL N 20181231 64942-1236_e2ad7a1f-c890-4f36-9b02-febc382d0ba1 64942-1236 HUMAN OTC DRUG Suave Revitalizing Mint and Eucalyptus AntiDandruff Conditioner Pyrithione Zinc SUSPENSION TOPICAL 20120209 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC .5 mL/100mL N 20181231 64942-1237_cb29bb35-0161-403e-9d26-d3e9477d8099 64942-1237 HUMAN OTC DRUG Suave Nourishing Coconut and Shea Butter AntiDandruff Conditioner Pyrithione Zinc SUSPENSION TOPICAL 20120209 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC .5 mL/100mL N 20181231 64942-1238_e1d46e68-b110-454b-ae59-14e10b1e78fd 64942-1238 HUMAN OTC DRUG Clear Men 2 in 1 Complete Care AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL N 20181231 64942-1240_3a6c129c-9543-4302-8289-6f7970b80928 64942-1240 HUMAN OTC DRUG Degree Girl Twilight Kiss Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1241_74187120-1214-4f77-bc26-28975a0950ca 64942-1241 HUMAN OTC DRUG Dove Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120214 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1242_fb5d9afc-866a-488b-b96f-d9f781358b9d 64942-1242 HUMAN OTC DRUG Dove Nature Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1243_87577d4a-67c8-4420-9601-9be47870a503 64942-1243 HUMAN OTC DRUG Dove Wild Rose Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1244_780a1859-e587-42bf-bb9e-201b605c5286 64942-1244 HUMAN OTC DRUG Simple Vital Vitamin Day Cream SPF 15 Homosalate, Octisalate, Avobenzone, and Octocrylene EMULSION TOPICAL 20120301 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE .12; .05; .03; .027 g/g; g/g; g/g; g/g E 20171231 64942-1245_5bccc639-0fc5-48e7-b3b3-9e1ed536e878 64942-1245 HUMAN OTC DRUG St. Ives Blemish and Blackhead Control Apricot Scrub Salicylic Acid EMULSION TOPICAL 20120301 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .02 g/g N 20181231 64942-1246_3cb130db-17b8-4711-b8d5-5d79722e9b55 64942-1246 HUMAN OTC DRUG St. Ives Green Tea Cleanser Salicylic Acid EMULSION TOPICAL 20120308 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .02 mL/mL N 20181231 64942-1247_e531aebc-1cfa-47b5-9495-07b7ad6ad9da 64942-1247 HUMAN OTC DRUG St. Ives Green Tea Scrub Salicylic Acid EMULSION TOPICAL 20120308 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .01 mL/mL N 20181231 64942-1248_87686883-277b-4e5a-a011-70c95808158e 64942-1248 HUMAN OTC DRUG Clear Men 2 in 1 Dry Scalp Hydration AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL N 20181231 64942-1249_51e1da3e-ac27-4431-b579-7251b0801515 64942-1249 HUMAN OTC DRUG Clear Men Strong and Full AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL N 20181231 64942-1250_36f8d93d-53bf-4c91-8aba-4a35ac4fcc6f 64942-1250 HUMAN OTC DRUG Clear Men 2 in 1 Clean and Refresh AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL N 20181231 64942-1252_4a07fc4a-738c-450e-9608-348c24964128 64942-1252 HUMAN OTC DRUG Clear Complete Care AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 mL/100mL N 20181231 64942-1253_b0a5ad97-922e-41c8-966b-a4f099c2947c 64942-1253 HUMAN OTC DRUG Dove Powder Roll On Antiperspirant and Deodorant Aluminum Chlorohydrate LIQUID TOPICAL 20120712 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 22 mg/100mL N 20181231 64942-1256_d53ad77c-a2cf-4acd-98d2-7cf362bbc5db 64942-1256 HUMAN OTC DRUG Dove Men plus Care Hydrate Face SPF 15 AVOBENZONE, ENSULIZOLE, OCTICSALATE LOTION TOPICAL 20120801 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE 3; 1; 5 g/100mL; g/100mL; g/100mL N 20181231 64942-1257_dbe4b3f2-d5aa-4cff-9fbf-38230f62db76 64942-1257 HUMAN OTC DRUG Degree Clinical Men Thermo Dry Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1258_0b404672-7c35-4f07-81cc-4175ebe8140c 64942-1258 HUMAN OTC DRUG Degree Clinical Protection Motion Sense Summer Strength Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1259_d96bef2e-2a7d-4d0f-aee7-4441c2d2bd5f 64942-1259 HUMAN OTC DRUG Noxzema ANTIBLEMISH Salicylic Acid CLOTH TOPICAL 20120901 OTC MONOGRAPH FINAL part333D Conopco Inc. SALICYLIC ACID .02 g/g N 20181231 64942-1260_0608f751-d060-4d8a-839b-d382bac36661 64942-1260 HUMAN OTC DRUG Dove Go Fresh Restore Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120910 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1261_298b64b8-2e7e-44d0-9509-e5ab543ff07e 64942-1261 HUMAN OTC DRUG Degree Ironman Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120920 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1262_04a3988c-d83d-435a-9ccc-06d80d76cab0 64942-1262 HUMAN OTC DRUG Axe Dry Apollo Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1263_41e5e3ee-1943-4deb-be59-94ff706c3ad8 64942-1263 HUMAN OTC DRUG Degree Motion Sense Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20120920 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1264_e08c4b3f-82cb-45c1-8502-3c9b9ba11980 64942-1264 HUMAN OTC DRUG Noxzema Bacteria Fighting Cleanser Triclosan SOAP TOPICAL 20121002 OTC MONOGRAPH NOT FINAL part333E CONOPCO Inc. d/b/a Unilever TRICLOSAN .003 g/g N 20181231 64942-1265_a6223503-9fae-42c7-be5e-9d2dad0b0c03 64942-1265 HUMAN OTC DRUG Noxzema AntiBlemish Daily Scrub Salicyclic Acid SOAP TOPICAL 20121002 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .01 g/g N 20181231 64942-1266_cde43908-f7a2-4a7d-a2d2-fc5dddc414e8 64942-1266 HUMAN OTC DRUG Degree Motion Sense Sexy Intrigue Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20121015 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1267_da6edb2e-2b95-47d0-894d-bdfa6cda969a 64942-1267 HUMAN OTC DRUG Dove Men plus Care Cool Silver Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20121015 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1268_11b69a75-a719-42dd-a91c-e0fd605338ce 64942-1268 HUMAN OTC DRUG Suave Ocean Breeze Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20121012 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-1269_c84ae180-47ba-46cc-9fc0-b6be5403ec86 64942-1269 HUMAN OTC DRUG Clear Men 2 in 1 Complete Care AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20151215 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1270_67fcfdc3-4d74-4c72-a93f-103fdb472947 64942-1270 HUMAN OTC DRUG Degree Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1272_a5841714-3aaa-4490-9ac3-d8fc5b02704b 64942-1272 HUMAN OTC DRUG Axe Dry Black Chill Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20121230 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1273_90b40983-0998-442b-a838-bd85cffed265 64942-1273 HUMAN OTC DRUG DOVE MEN PLUS CARE ANTI DANDRUFF Pyrithione Zinc SHAMPOO TOPICAL 20130101 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1274_ee75de76-8e19-46a6-8b44-3c1e0457d1cd 64942-1274 HUMAN OTC DRUG Dove Clear Solid Beauty Finish Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1275_f4c40e1b-e53d-4362-87af-810c13c289e5 64942-1275 HUMAN OTC DRUG Dove Clear Solid Soothing Chamomile Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1276_a67164b2-6adc-447d-80f6-89f263419093 64942-1276 HUMAN OTC DRUG Dove Visibly Clear Cool Essentials Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1277_8040199b-cc42-4801-90b9-84e3bca32f50 64942-1277 HUMAN OTC DRUG Dove Clear Solid Revive Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1278_326dfe1a-2df1-48b8-8986-654e584ce7dc 64942-1278 HUMAN OTC DRUG Dove Clear Solid Rebalance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1279_90beaf64-9322-4a18-9f01-d6e7058ece77 64942-1279 HUMAN OTC DRUG Degree Clear Solid Silky Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1280_d418e6f7-5008-4c4b-935c-ba7345f76d7c 64942-1280 HUMAN OTC DRUG Degree Clear Solid Floral Breeze Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1281_415b32c8-f1de-4980-9471-f11bb58773ac 64942-1281 HUMAN OTC DRUG Degree Clear Solid Shower Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130228 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1282_21fa9495-35c7-44f4-aa4f-a5492d973c08 64942-1282 HUMAN OTC DRUG Degree Clear Solid Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1283_f91c33b0-b373-4863-a46b-8fb8a85deb67 64942-1283 HUMAN OTC DRUG Degree Clear Solid Lightly Scented Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1284_b5f08ecf-a372-4972-9e3f-db378e1bdc98 64942-1284 HUMAN OTC DRUG Ponds Luminous Finish BB cream Medium SPF 15 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20130617 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever OCTINOXATE; ZINC OXIDE 7.49; 5.12 g/100mL; g/100mL N 20181231 64942-1285_9bd8e2af-4f09-43a1-b5c4-d190a9312362 64942-1285 HUMAN OTC DRUG Ponds Luminous Finish BB cream Light SPF 15 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20130617 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever OCTINOXATE; ZINC OXIDE 7.49; 5.12 g/100mL; g/100mL N 20181231 64942-1286_54dcbd65-b03e-4360-a0ab-645a5f912c15 64942-1286 HUMAN OTC DRUG Clear Men Cool Sport Mint AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1287_5724c2ef-4b84-4de9-b238-6bb8663b49a9 64942-1287 HUMAN OTC DRUG Clear Men Clean and Refresh AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20120509 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1288_57ba6673-411d-44c3-bb65-ac640e5aab54 64942-1288 HUMAN OTC DRUG Ponds Luminous Moisture Day SPF 15 AVOBENZONE, ENSULIZOLE, OCTICSALATE LOTION TOPICAL 20120801 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE 3; 1; 5 g/100mL; g/100mL; g/100mL N 20181231 64942-1289_b51281c8-d5e5-43e5-9846-f9d6f28b46e3 64942-1289 HUMAN OTC DRUG Axe AntiDandruff Styling Pyrithione Zinc CREAM TOPICAL 20130219 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC .2 g/100g N 20181231 64942-1290_0213299f-168d-4412-820f-965cbd46ce9d 64942-1290 HUMAN OTC DRUG Simple Protecting Light Moisturizer SPF 15 AVOBENZONE, ENSULIZOLE, OCTICSALATE LOTION TOPICAL 20130701 OTC MONOGRAPH FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE 3; 1; 5 g/100mL; g/100mL; g/100mL N 20181231 64942-1292_da4b1de7-bd80-411a-9fe1-4a2e983b8d86 64942-1292 HUMAN OTC DRUG Suave Powder Antiperspirant and Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20130301 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g N 20181231 64942-1293_f0b7568c-9a7f-4089-959e-b1a9c3a28590 64942-1293 HUMAN OTC DRUG Suave Fresh Antiperspirant Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20130301 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g N 20181231 64942-1294_5828cca5-24c5-47bb-ba6f-70c70fd4d81c 64942-1294 HUMAN OTC DRUG Degree Shower Clean Antiperspirant Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20130409 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g N 20181231 64942-1295_0cf51f38-5fdf-4eba-bd39-b20a13df3b19 64942-1295 HUMAN OTC DRUG Degree Sport Antiperspirant and Deodorant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20130409 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 8.8 g/100g N 20181231 64942-1296_b8981683-5d96-4b19-be4a-320b0e4d4354 64942-1296 HUMAN OTC DRUG St. Ives Blemish Control Green Tea Scrub Salicylic Acid EMULSION TOPICAL 20130615 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .01 g/mL N 20181231 64942-1297_f26b3035-6587-4a03-854a-841194c184e4 64942-1297 HUMAN OTC DRUG St. Ives Green Tea Cleanser Salicylic Acid EMULSION TOPICAL 20130615 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .02 g/mL N 20181231 64942-1298_44f83d25-8668-446d-a512-8a874f860563 64942-1298 HUMAN OTC DRUG Degree Expert Protection Motion Sense Daisy Fresh Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130630 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1299_87be10e9-0400-48a7-a297-464a10a0191d 64942-1299 HUMAN OTC DRUG Degree Expert Protection Motion Sense Peach Burst Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130630 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1300_37bc5a36-0fa2-4720-9ee2-da3514deac6f 64942-1300 HUMAN OTC DRUG Dove Go Sleeveless Shea Butter Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130630 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1301_27282615-66b5-4783-af13-fa4a531aaafe 64942-1301 HUMAN OTC DRUG Degree Clinical Protection Motion Sense Stress Control Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1302_da9d0511-98fd-4d2e-af00-c3f922f24207 64942-1302 HUMAN OTC DRUG Axe 2 in 1 Armor AntiDandruff 2 in 1 Pyrithione Zinc SHAMPOO TOPICAL 20130610 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1303_5c687ae8-fdcf-47d7-9dce-112f0022eee2 64942-1303 HUMAN OTC DRUG Degree Clinical Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1304_0b823128-d25b-49a6-94ed-fe74ca335de2 64942-1304 HUMAN OTC DRUG Degree Clinical Shower Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1305_580ae164-7a60-4d8c-993b-7bf0b27a4be7 64942-1305 HUMAN OTC DRUG Dove DermaSeries Rough Patch Treatment Dimethicone LOTION TOPICAL 20131010 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever DIMETHICONE 1.1 g/100mL N 20181231 64942-1306_f43693e6-cb47-4f44-a2af-ece97e5ff046 64942-1306 HUMAN OTC DRUG Dove DermaSeries Eczema Therapy Cream Oatmeal CREAM TOPICAL 20131015 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever OATMEAL 1 g/100mL N 20181231 64942-1307_81ca3d31-966b-41e1-8db5-7e139f8ad15f 64942-1307 HUMAN OTC DRUG Dove DermaSeries Intense Repairing Body Cream Dimethicone CREAM TOPICAL 20131015 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever DIMETHICONE 6 g/100mL N 20181231 64942-1308_8d6d0c09-aedd-4d40-9e0d-5a1ef12ea5f8 64942-1308 HUMAN OTC DRUG Suave Ocean Breeze Antiperspirant and Deodorant Aluminum Chlorohydrate STICK TOPICAL 20090407 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-1309_93ad0552-1f3a-42c4-987a-6d374ce2058b 64942-1309 HUMAN OTC DRUG Clear 2 in 1 Scalp Comfort AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1310_ebd7ad41-33f5-4c8b-be53-c9fdf8f898be 64942-1310 HUMAN OTC DRUG Clear Men 2 in 1 Dry Scalp Hydration AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20151215 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1311_fc1c23b4-778f-4fec-819a-c3769e535d50 64942-1311 HUMAN OTC DRUG Clear Men Deep Clean Hydration AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20131201 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1312_99844fef-8f97-469d-a490-4e5a12fe0346 64942-1312 HUMAN OTC DRUG Clear Men Ocean Mineral AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20131201 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1313_1c4d8f5f-0c28-4c41-a824-39be04accd69 64942-1313 HUMAN OTC DRUG Clear Men Citrus Fresh Hydration AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20131201 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1314_09067fc3-e062-4caf-978d-ffd7c4236e3c 64942-1314 HUMAN OTC DRUG Axe Dry Peace Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131130 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1315_a9531aa6-c818-4242-83be-28fe7ac9b561 64942-1315 HUMAN OTC DRUG Axe Dry Harmony Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131130 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1316_1c83a155-e9c7-4b04-aaec-e400eccea178 64942-1316 HUMAN OTC DRUG Suave Clinical Protection Almond Verbena Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131001 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1317_692021e5-4265-4f3f-8741-76d1a6413864 64942-1317 HUMAN OTC DRUG Degree Overtime Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1318_14dd20a2-ddb2-43c7-8a99-b7f7f7529889 64942-1318 HUMAN OTC DRUG Degree Cool Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1319_4f4590f6-4d3f-47df-8eb8-493b5cd09434 64942-1319 HUMAN OTC DRUG Suave Almond Verbena Antiperspirant Deodorant Aluminum Chlorohydrate STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-1320_a6743400-2f13-404d-869e-b97cd0b0f6db 64942-1320 HUMAN OTC DRUG Degree Adrenaline Everest Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131202 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1321_0b16b811-b3f4-484b-b2ba-04b977f7d03f 64942-1321 HUMAN OTC DRUG Degree Adrenaline Ironman Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131202 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1322_5e6b27bd-5534-4a64-adb0-8c5dce944ff5 64942-1322 HUMAN OTC DRUG Degree Adrenaline Adventure Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131202 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1323_ce9657ac-3ab4-42bc-a7a7-4d105b134523 64942-1323 HUMAN OTC DRUG Degree Adrenaline Extreme Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131202 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1324_51fc5b19-a573-43f4-bdb7-ff862b33e0a3 64942-1324 HUMAN OTC DRUG Degree Motion Sense Peach Burst Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1325_172bfe39-101e-43ad-b668-95d71d9944af 64942-1325 HUMAN OTC DRUG Degree Sheer Lilac Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1326_1bbe36c8-cdda-46d2-9d8d-1436cbd6822c 64942-1326 HUMAN OTC DRUG Degree Motion Sense Berry Cool Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1327_bc826efa-82b3-4ee6-b5a7-94c0f694ffb2 64942-1327 HUMAN OTC DRUG Degree Motion Sense Tropical Rush Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1328_a11da22e-7c63-4eaf-837e-dee7dfa75c31 64942-1328 HUMAN OTC DRUG Degree Motion Sense Daisy Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1329_c3204ef5-75d9-433b-b1ee-5b92331b41c9 64942-1329 HUMAN OTC DRUG Degree Motion Sense Shower Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1330_ee69ed8a-f7ba-4022-b953-1cef67700072 64942-1330 HUMAN OTC DRUG Degree Motion Sense Sheer Powder Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1331_af84c5a7-e40c-4e89-8a20-d7e2e7037251 64942-1331 HUMAN OTC DRUG Degree Motion Sense Sexy Intrigue Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1332_fb54b7c7-e03c-40e3-913e-2c0da382a626 64942-1332 HUMAN OTC DRUG Degree Motion Sense Fresh Energy Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1333_60c50139-6d3a-48b2-a92f-a6832f95251f 64942-1333 HUMAN OTC DRUG Dove Men plus Care Sensitive Face AVOBENZONE, ENSULIZOLE, OCTICSALATE, OCTOCRYLENE LOTION TOPICAL 20160112 OTC MONOGRAPH NOT FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 2; 1.5; 5; 1.3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 64942-1334_dd4fd32d-b841-452b-8fdb-112e9d61aedf 64942-1334 HUMAN OTC DRUG Dove Men plus Care Hydrate Face AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20160122 OTC MONOGRAPH NOT FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 2; 1.5; 5; 1.3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 64942-1335_bc237a1a-73df-4022-9bee-dbb160e7e9f2 64942-1335 HUMAN OTC DRUG Degree Adrenaline Sport Defense Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131202 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1336_f6341f4c-618c-4f83-9a2b-b299f187c973 64942-1336 HUMAN OTC DRUG St. Ives Blackhead Clearing Green Tea Scrub Salicylic Acid EMULSION TOPICAL 20140101 OTC MONOGRAPH FINAL part333D CONOPCO Inc. d/b/a Unilever SALICYLIC ACID .01 g/mL N 20181231 64942-1337_f95453a7-7a7f-4237-9245-db33db8afd2a 64942-1337 HUMAN OTC DRUG Dove Men plus Care Clean Comfort Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1338_6e43afed-0abd-45e0-b433-9afa18e78bd0 64942-1338 HUMAN OTC DRUG Dove Men plus Care Extra Fresh Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1339_6556082f-af59-4b5c-bb2a-6fd2a69164a5 64942-1339 HUMAN OTC DRUG Dove Men plus Care Aqua Impact Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1340_e8d83552-c080-45a5-b8e4-2032862422f9 64942-1340 HUMAN OTC DRUG Dove Men plus Care Fresh Awake Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20131215 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1341_d2c6f53b-28c1-4ced-9a7a-98ff196ad67c 64942-1341 HUMAN OTC DRUG Dove Advanced Care Nourished Beauty Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1342_1b3415b2-6ed1-4d6c-8084-926369dca6fc 64942-1342 HUMAN OTC DRUG Dove Advanced Care Beauty Finish Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1343_651a8852-97d2-4e8c-90d3-0389e81c09a4 64942-1343 HUMAN OTC DRUG Dove Advanced Care Cool Essentials Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1344_20cbffa2-5004-46cf-811f-61ec67b5c2b6 64942-1344 HUMAN OTC DRUG Dove Advanced Care Rebalance Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1345_ee558efd-9e9a-4e4e-a39a-2d081e12551f 64942-1345 HUMAN OTC DRUG Dove Advanced Care Revive Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1346_f68854ed-4bf4-4882-8f12-d43ae7faed52 64942-1346 HUMAN OTC DRUG Dove Advanced Care Skin Renew Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1347_cc2cfc52-c903-4224-ab31-9cbbd0481b54 64942-1347 HUMAN OTC DRUG Dove Advanced Care Sheer Touch Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1348_c2397af6-8b9e-46e3-945e-d9c834785818 64942-1348 HUMAN OTC DRUG Dove Advanced Care Pink Rosa Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1349_c56adc6f-7d58-417a-8a73-4cae7c116219 64942-1349 HUMAN OTC DRUG Dove Advanced Care Shea Butter Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1350_16e4a128-670f-46ce-83b0-41ade68722de 64942-1350 HUMAN OTC DRUG Dove Advanced Care Sensitive Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1351_a7085f0c-0327-4ab9-bd2e-6b3e254b3765 64942-1351 HUMAN OTC DRUG Dove Advanced Care Caring Coconut Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1352_4a1a1c2d-dbf4-48b7-8ef0-2fffc761e984 64942-1352 HUMAN OTC DRUG Dove Go Sleeveless Sensitive Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140120 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1353_db851695-6b1c-4cb0-bfb6-dbfb14bfe804 64942-1353 HUMAN OTC DRUG Suave Professionals Men 2 in 1 Classic Clean AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20140122 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1354_542cf41f-259a-422f-a8ba-54ab1467efe6 64942-1354 HUMAN OTC DRUG Axe Gold Temptation Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140326 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1355_cad5821e-e669-49a2-a49b-7ba79f50cf85 64942-1355 HUMAN OTC DRUG Simple Light Moisturizer SPF 15 AVOBENZONE, ENSULIZOLE, OCTICSALATE, OCTOCRYLENE LOTION TOPICAL 20160122 OTC MONOGRAPH NOT FINAL part352 CONOPCO Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 2; 1.5; 5; 1.3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 64942-1356_8aeece4c-7a03-4530-9535-cbc2d660b5c1 64942-1356 HUMAN OTC DRUG Clear Complete Care Nourishing AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20140413 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1357_1a33afeb-9d19-409b-8f93-537c32bff8f6 64942-1357 HUMAN OTC DRUG Axe Freeze AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20090802 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1358_7ec7937e-f116-4b9f-b888-a075736cc6a5 64942-1358 HUMAN OTC DRUG Dove Cool Essentials Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1359_fdc5c966-086f-4290-a9df-62463cce2d79 64942-1359 HUMAN OTC DRUG Dove Beauty Finish Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1360_f21299cd-6bb4-437a-9aca-fb42f12d9d09 64942-1360 HUMAN OTC DRUG Dove Sensitive Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1361_53419439-ccc8-4a49-b6bd-5cb3170a4e76 64942-1361 HUMAN OTC DRUG Dove Clear Tone Skin Renew Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1362_12c43014-9737-41cc-a38a-4456d23bf8d8 64942-1362 HUMAN OTC DRUG Dove Revive Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1363_51aa933f-f2b7-49c9-9115-e721cff81d2b 64942-1363 HUMAN OTC DRUG Dove Nourished Beauty Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1364_50ea588f-4e09-4d37-9729-d7836efdb251 64942-1364 HUMAN OTC DRUG Dove Men plus Care Extra Fresh Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1365_420c3dcb-4a2a-4dc3-82cd-1575c5045045 64942-1365 HUMAN OTC DRUG Dove Men plus Care Cool Silver Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1366_87668a43-2b8a-4b31-8f8a-e421fb5545d3 64942-1366 HUMAN OTC DRUG Dove Men plus Care Clean Comfort Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1367_15f408ce-b226-473a-a441-975d37e0a4ad 64942-1367 HUMAN OTC DRUG Dove Men plus Care Unscented Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1368_aa7f02d2-78d6-480f-a965-1bbe02cf7282 64942-1368 HUMAN OTC DRUG Axe Air Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1369_bc8b7aa6-8037-4282-bc22-42c71203eb15 64942-1369 HUMAN OTC DRUG Axe Night Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1371_7aa86723-c9ad-4f0d-b698-195b66e7ca48 64942-1371 HUMAN OTC DRUG Axe Island Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1372_4714a090-92c8-4292-8071-bed846f03cda 64942-1372 HUMAN OTC DRUG Axe Air Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1373_d5ea5f9c-8e66-497f-99b9-83b454fc592b 64942-1373 HUMAN OTC DRUG Axe Night Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1374_797099fe-1fd1-406f-ae1b-e693355a79a6 64942-1374 HUMAN OTC DRUG Axe Forest Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1375_dc6b6ce2-ef33-4b70-9214-ec0664b32ccb 64942-1375 HUMAN OTC DRUG Axe Island Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1376_190fc27b-76e1-4660-ab76-aef6b66238c7 64942-1376 HUMAN OTC DRUG Degree Shower Clean Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1377_e84d9fea-7461-4654-ad12-3774ac8bb4ce 64942-1377 HUMAN OTC DRUG Degree Fresh Energy Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1378_8cdbe86f-be36-4182-ba46-d075d7356d41 64942-1378 HUMAN OTC DRUG Degree Sheer Powder Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1379_acc96ddc-99e3-41fc-ab7f-01dd8d13f26b 64942-1379 HUMAN OTC DRUG Degree Peach Burst Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1380_4c7bf1e4-fbf5-4435-930d-bc45c0cade97 64942-1380 HUMAN OTC DRUG Degree Everest Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1381_2c1fa120-6c0c-4217-9c93-5954bfc0d83f 64942-1381 HUMAN OTC DRUG Degree Extreme Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1382_4c8a5284-6ada-4a9f-acd8-4701ab1b08ae 64942-1382 HUMAN OTC DRUG Degree Adventure Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1383_01118240-5f48-4892-85d8-c323007e17ca 64942-1383 HUMAN OTC DRUG Degree Sport Defense Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1385_24b371ec-40c3-404a-9776-cdc32d4832cb 64942-1385 HUMAN OTC DRUG Degree Overtime Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1386_f60ebf00-cce9-404b-8606-6a34409275fb 64942-1386 HUMAN OTC DRUG Degree MotionSense Ironman Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1387_543a0ac9-7b30-490c-bb3b-ea79ca732531 64942-1387 HUMAN OTC DRUG Degree MotionSense Overtime Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1388_9c798a80-ed98-4b96-a24b-f3b15997490a 64942-1388 HUMAN OTC DRUG Degree MotionSense Cool Rush Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1389_6585dbc1-9b6f-48b5-a3d2-3fcb305dc83c 64942-1389 HUMAN OTC DRUG Degree MotionSense Adventure Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1390_1cfd6095-e710-4ef6-9d80-50537dfb5e71 64942-1390 HUMAN OTC DRUG Degree MotionSense Everest Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1391_f67d1fcd-5beb-4e9a-9409-7eec8f92364d 64942-1391 HUMAN OTC DRUG Degree MotionSense Extreme Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1392_b414587f-7284-47c9-bbf9-b2161b188d33 64942-1392 HUMAN OTC DRUG Degree MotionSense Sport Defense Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1393_7dc37917-e774-4cc4-a56f-2b1367f47623 64942-1393 HUMAN OTC DRUG Dove Clinical Protection Powder Soft Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1394_d81be7e9-ab8b-4b7c-9cc4-9e1cad8ccaca 64942-1394 HUMAN OTC DRUG Degree 5 In 1 Clinical Protection Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1395_ec4d30f4-619f-4f56-8152-0ae5edf02415 64942-1395 HUMAN OTC DRUG Dove Advanced Care Powder Soft Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1396_dff04b6c-9d0a-450d-bff5-182921f47f12 64942-1396 HUMAN OTC DRUG Dove Advanced Care Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1397_09646ae3-6e96-4fc3-9b09-18d28cc67075 64942-1397 HUMAN OTC DRUG Dove Men plus Care Sensitive Shield Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1398_b7dc01f8-f39d-4035-b57c-fda0478890e0 64942-1398 HUMAN OTC DRUG Degree Sexy Intrigue Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1399_f1c5ace4-8e47-45b2-861e-972f5c5760f9 64942-1399 HUMAN OTC DRUG Degree Motion Sense Blossoming Orchid Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1400_eee73747-7e5c-43b0-a74e-2be2b0a81b32 64942-1400 HUMAN OTC DRUG Vaseline Lip Therapy Advanced Healing Petrolatum OINTMENT TOPICAL 20040120 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 100 g/100g N 20181231 64942-1401_e746a7f6-acec-4009-a393-ee287b5812cb 64942-1401 HUMAN OTC DRUG Vaseline Intensive Care Deep Moisture Petroleum CREAM TOPICAL 20151001 OTC MONOGRAPH FINAL part347 Conopco Inc. d/b/a Unilever PETROLATUM 30 g/100g N 20181231 64942-1402_adaff79f-fd1f-49ba-9cac-e13f1fcf0dc2 64942-1402 HUMAN OTC DRUG Axe Signature Air Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1403_ac7f6797-76b2-4536-bd39-9f32dcbd2cf1 64942-1403 HUMAN OTC DRUG Axe Signature Night Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1404_6b0d0945-c6b9-4272-952a-18636c935f16 64942-1404 HUMAN OTC DRUG Axe Signature Forest Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1405_5da31c0e-bba6-4f29-b384-2c489fc2d29f 64942-1405 HUMAN OTC DRUG Axe Signature Island Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1406_e25aa0a5-0fe0-4410-a5b8-9390defe40c1 64942-1406 HUMAN OTC DRUG Axe Urban Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1407_374d27bc-db78-4cf3-b1b9-6787b534dd8e 64942-1407 HUMAN OTC DRUG Axe Adrenaline Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1408_302eafaa-584f-4657-9b01-78f5bfb70866 64942-1408 HUMAN OTC DRUG Degree for Women Motionsense Active Shield Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1409_538a8f31-4ba4-411b-8736-5ce3c8deb615 64942-1409 HUMAN OTC DRUG Degree Motionsense Daisy Fresh Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1410_06cba152-2ce5-4425-8c90-0f742be3e32c 64942-1410 HUMAN OTC DRUG Degree For Men Motionsense Cool Rush Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1411_671eeebe-d179-43a4-be91-d4e4343ccd66 64942-1411 HUMAN OTC DRUG Degree For Men Motionsense Active Shield Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1412_f9e8d31d-5589-4533-9f7b-0c31dfbe8f51 64942-1412 HUMAN OTC DRUG Dove Original Clean Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1413_84ea8083-50ba-43e7-9bee-1612ab7323a7 64942-1413 HUMAN OTC DRUG Dove Soothing Chamomile Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1414_0350c0bd-ba47-4861-9982-098771bc68c6 64942-1414 HUMAN OTC DRUG Dove Men plus Care Cool Fresh Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1415_714bc9c3-1ebf-40e6-aff4-2c0959468483 64942-1415 HUMAN OTC DRUG Dove Men plus Care Sensitive Shield Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1416_b1fe1b7b-87be-4f03-91e1-3541a7a72303 64942-1416 HUMAN OTC DRUG Dove Advanced Care Restore Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1417_168ed7e1-9d62-4fd8-8ea0-40a9b71bf185 64942-1417 HUMAN OTC DRUG Dove Advanced Care Soothing Chamomile Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1418_89b7de75-b5d5-4a00-9d3b-3446f2cca61f 64942-1418 HUMAN OTC DRUG Axe Signature Air Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1419_e4dc3ecd-b237-4dd7-bc1c-93cc04bed14e 64942-1419 HUMAN OTC DRUG Axe Signature Forest Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1420_f665420d-e1d3-4830-885f-95c69f442847 64942-1420 HUMAN OTC DRUG Axe Signature Island Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1421_c3cedb3d-7b0c-49c9-a746-f00aec319408 64942-1421 HUMAN OTC DRUG Axe Signature Night Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1422_faff0b6d-6e3e-4095-9e7c-9283d1043ee2 64942-1422 HUMAN OTC DRUG Axe Urban Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20141101 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1423_8f026922-5ba1-43da-ba26-24fea4e9ebb0 64942-1423 HUMAN OTC DRUG Axe Adrenaline Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1424_e7d21117-ff3a-480b-8625-b7ea18192573 64942-1424 HUMAN OTC DRUG Degree Men Sport Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 19.1 g/100g N 20181231 64942-1425_8f0b8219-6c80-484b-aff2-7a3452eff59e 64942-1425 HUMAN OTC DRUG Degree Body Responsive Shower Clean Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 19.1 g/100g N 20181231 64942-1426_caa7ebb6-2e63-4c61-bd95-82df1dc80ea5 64942-1426 HUMAN OTC DRUG Suave 24 Hour Fresh Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 19.1 g/100g N 20181231 64942-1427_b4d040e6-4134-4104-b82e-132b25c5a453 64942-1427 HUMAN OTC DRUG Suave 24 Hour Powder Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 19.1 g/100g N 20181231 64942-1428_5a053695-8a7d-4630-a5af-a7da572bf8d0 64942-1428 HUMAN OTC DRUG Dove Men plus Care Cool Fresh Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1429_13e0d04f-9b88-42e7-a78b-262a778b29c1 64942-1429 HUMAN OTC DRUG Degree Clinical Protection Active Shield Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1430_eee8887f-d344-4f57-a366-4e04948c7803 64942-1430 HUMAN OTC DRUG Degree MotionSense Active Shield Antiperspirant Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1431_6d18853b-4fc0-4db8-886f-fa61ecfb382f 64942-1431 HUMAN OTC DRUG Degree Men MotionSense Active Shield Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1432_abf9cb22-7f97-4899-ba22-472d4b96908b 64942-1432 HUMAN OTC DRUG Suave Coconut Kiss Antiperspirant Deodorant Aluminum Chlorohydrate STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-1434_7de34da6-bb15-4416-ae56-d03107fd76ee 64942-1434 HUMAN OTC DRUG Clear Complete Scalp Care Antidandruff Pyrithione Zinc SHAMPOO TOPICAL 20151215 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1435_750e0b65-4e5e-4088-92ea-c6ce14fc4481 64942-1435 HUMAN OTC DRUG Clear Complete Scalp Care AntiDandruff Conditioner Pyrithione Zinc SUSPENSION TOPICAL 20151215 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC .5 g/100mL N 20181231 64942-1436_0a40c294-9786-4e28-b121-0d82e3a23dc9 64942-1436 HUMAN OTC DRUG Suave Men Deep Clean Mint Refresh AntiDandruff Pyrithione Zinc SHAMPOO TOPICAL 20151215 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1437_77b1ee82-a503-4075-918e-cd0528048a6c 64942-1437 HUMAN OTC DRUG Suave Men 2 in 1 Pure Power Antidandruff Pyrithione Zinc SHAMPOO TOPICAL 20151215 OTC MONOGRAPH FINAL part358H Conopco Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1438_935d48aa-2070-42bd-9ded-119ee3525a48 64942-1438 HUMAN OTC DRUG Suave Clinical Protection Coconut Kiss Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1439_84ec3159-a00c-421a-9e4c-c37d962d107d 64942-1439 HUMAN OTC DRUG Dove Clinical Protection Skin Renew Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1440_b0a39a50-ba3c-42ed-a4ff-4e8de75e9fd0 64942-1440 HUMAN OTC DRUG Dove Clinical Protection Original Clean Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1441_8815610e-d159-4d5f-8238-f7e1729b7daa 64942-1441 HUMAN OTC DRUG Dove Clinical Protection Cool Essentials Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1442_194d99c6-c83c-49f6-bc39-b0513d5c5032 64942-1442 HUMAN OTC DRUG Degree Men Black and White Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160720 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1443_ef43fa78-f4a9-4e97-b09b-1890cb684047 64942-1443 HUMAN OTC DRUG Degree MotionSense Ultraclear Black and White Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160902 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1444_8efe5cc0-22c9-4d78-b51c-949502d55092 64942-1444 HUMAN OTC DRUG Degree Men MotionSense Ultraclear Black and White Fresh Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160914 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1445_9380928e-acf7-4767-8b1b-8288e9702caf 64942-1445 HUMAN OTC DRUG Degree MotionSense Ultraclear Black and White Pure Clean Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160914 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1446_584cb1c0-b905-4dbc-ae21-e4228ba308da 64942-1446 HUMAN OTC DRUG Degree Men MotionSense Stress Control Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160914 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1447_a7b167d7-76d0-4e42-a274-a4cac01d8c68 64942-1447 HUMAN OTC DRUG Degree MotionSense Stress Control Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160919 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1448_c8347ffc-a343-49dc-b0ca-9383b6bccc46 64942-1448 HUMAN OTC DRUG Dove Caring Coconut Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160903 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1449_13cdc207-91f3-4da4-bae8-498dca5fe0a9 64942-1449 HUMAN OTC DRUG Dove Powder Soft Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1450_e0c68edc-2c05-47f0-9726-bd46338d5cbb 64942-1450 HUMAN OTC DRUG Dove Men plus Care Invisible Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1451_4557f638-f76d-4046-94a7-60f1cbdec5cf 64942-1451 HUMAN OTC DRUG Dove Invisible Clear Finish Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1452_1552e1e9-b2e8-48dc-b4fd-0e6059e6a3eb 64942-1452 HUMAN OTC DRUG Dove Invisible Sheer Fresh Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1453_ae489b7d-cda6-472f-b87b-eb96067c2141 64942-1453 HUMAN OTC DRUG Dove Men plus Care Invisible Fresh Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160919 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1454_8ec66810-128d-4d94-95e7-4a0e989e1909 64942-1454 HUMAN OTC DRUG Dove Men plus Care Minerals and Sage Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160903 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1455_1769a052-2abe-47ca-a78a-b302379cdd5f 64942-1455 HUMAN OTC DRUG Dove Men plus Care Mineral Powder and Sandalwood Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160914 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1456_37fbaa71-d82f-4207-b757-4d5f8d463859 64942-1456 HUMAN OTC DRUG Axe Signature Gold Dry Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20160907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1457_c49e9b91-348e-436e-a2f8-5502766b2dfb 64942-1457 HUMAN OTC DRUG Suave Clinical Protection Lavender Fresh Anti-Perspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20160930 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1458_172fa940-a0de-489a-a6fa-83f7f1ee018b 64942-1458 HUMAN OTC DRUG Suave Clinical Protection Sweet Pea and Violet Anti-Perspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161003 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1459_43c42f54-2f40-4313-a48a-511b61b37774 64942-1459 HUMAN OTC DRUG Suave Clinical Protection Tropical Paradise Anti-Perspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161003 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 64942-1460_cddeb2de-c71d-40e1-88ea-170b0e0276af 64942-1460 HUMAN OTC DRUG Dove Men plus Care Invisible 48h Powerful Protection Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161003 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1461_a92bb602-5186-4592-a908-2dbc6716ed08 64942-1461 HUMAN OTC DRUG Dove Advanced Care Invisible Clear Finish 48h Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161003 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1462_435affe2-4fa8-4455-b9b4-35fecdbdd077 64942-1462 HUMAN OTC DRUG Dove Men plus Care Elements Mineral and Sage Antiperspirant Aluminum zirconium tetrachlorohydrex GLY STICK TOPICAL 20161010 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1463_606ef165-fd77-4bb2-8882-97eaccf0115c 64942-1463 HUMAN OTC DRUG Axe Black Antiperspirant Aluminum zirconium tetrachlorohydrex GLY STICK TOPICAL 20161011 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1464_c7aa5421-1b99-4368-8b72-a20f921a630b 64942-1464 HUMAN OTC DRUG Axe Signature Gold 48HR Antiperspirant Aluminum zirconium tetrachlorohydrex GLY STICK TOPICAL 20161012 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1465_6653e926-7e2b-4863-a616-76d556b89704 64942-1465 HUMAN OTC DRUG Degree Men Motionsense UltraClear Black and White Fresh 48H Antiperspirant Aluminum zirconium tetrachlorohydrex GLY STICK TOPICAL 20161012 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1466_5665e606-a739-00e5-e054-00144ff8d46c 64942-1466 HUMAN OTC DRUG Degree Men Motionsense UltraClear Black and White 48H Antiperspirant Aluminum zirconium tetrachlorohydrex GLY STICK TOPICAL 20161008 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1467_5bfb9bec-7318-ef55-e053-2a91aa0ae1ae 64942-1467 HUMAN OTC DRUG Degree Motionsense UltraClear Black and White Invisible Solid 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161008 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1468_4a7cd55f-5107-4e04-9ae0-2e55e79e7156 64942-1468 HUMAN OTC DRUG Degree Motionsense UltraClear Black and White Pure Clean Invisible Solid 48H Antiperspirant Aluminum zirconium tetrachlorohydrex GLY STICK TOPICAL 20161012 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1469_2fd7a06a-8770-470c-8e74-0b619a4b0094 64942-1469 HUMAN OTC DRUG Axe You Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161014 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1470_51ee66ee-e0f0-48f5-9849-9df2f3493bd4 64942-1470 HUMAN OTC DRUG Dove Advanced Care Lavender Fresh 48h Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161016 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1471_b5c13174-faa4-4b95-9464-2e43dd689356 64942-1471 HUMAN OTC DRUG Dove Bloom 24h Invisible Solid Antiperspirant Deodorant Aluminum Chlorohydrate STICK TOPICAL 20161018 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-1472_06c722d1-6cbf-4065-8f94-2a7151a07e92 64942-1472 HUMAN OTC DRUG Axe Signature Forest Antiperspirant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20161019 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1473_95f00518-2e1f-41c9-ae23-87a69b4e679f 64942-1473 HUMAN OTC DRUG Axe Signature Island Antiperspirant Aluminum zirconium terachlorohydrex GLY STICK TOPICAL 20161019 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1474_57d528b9-0af4-36c9-e053-2991aa0a5f86 64942-1474 HUMAN OTC DRUG Axe Signature Night Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161019 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1475_8a84d0bb-a2b2-4801-98f1-41c64b90f874 64942-1475 HUMAN OTC DRUG Dove Fresh 24h Invisible Solid Antiperspirant Deodorant Aluminum chlorohydrate STICK TOPICAL 20161026 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-1476_bb13ab1b-832f-4e95-a520-1b240b9f8c2c 64942-1476 HUMAN OTC DRUG Dove Original Clean 24h Invisible Solid Antiperspirant Deodorant Aluminum Chlorohydrate STICK TOPICAL 20161107 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-1477_a7b8e538-98df-4f09-9e74-33f9ccc4a3fb 64942-1477 HUMAN OTC DRUG Dove Powder 24h Invisible Solid Antiperspirant Deodorant Aluminum Chlorohydrate STICK TOPICAL 20161107 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-1478_9e7b15f9-70af-45a9-bea9-62801598292c 64942-1478 HUMAN OTC DRUG Dove Sensitive 24h Invisible Solid Antiperspirant Deodorant Aluminum Chlorohydrate STICK TOPICAL 20161107 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20 g/100g N 20181231 64942-1479_58a86138-efb6-46ea-9488-fa9dc00ee9ea 64942-1479 HUMAN OTC DRUG Dove Men plus Care Elements Mineral Powder and Sandalwood Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161107 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1480_f0a081a0-1f6f-4714-af0a-10cfe7673bc4 64942-1480 HUMAN OTC DRUG Degree Men Motionsense Stress Control 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161024 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1481_07911b64-c94f-404f-86e0-e5a637d30c09 64942-1481 HUMAN OTC DRUG Degree Motionsense Stress Control Invisible Solid Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161024 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1482_b237dd7c-0157-439f-8790-491b624057d1 64942-1482 HUMAN OTC DRUG Dove Advanced Care Invisible Sheer Fresh 48h Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161108 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1483_5a476482-df9a-4e24-885c-e70ecc2fc9c6 64942-1483 HUMAN OTC DRUG Axe Signature Daily Dandruff Defense Anti-Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20161110 OTC MONOGRAPH FINAL part358H Conopco, Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1484_1bd24919-8ff2-4964-a6f7-59670e8ada3b 64942-1484 HUMAN OTC DRUG Dove Dermacare Scalp Pure Daily Care Anti-Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20161106 OTC MONOGRAPH FINAL part358H Conopco, Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1485_64d9914e-7e33-4a9e-9b40-32b29091214b 64942-1485 HUMAN OTC DRUG Dove Dermacare Scalp Pure Daily Care 2 In 1 Anti-Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20161110 OTC MONOGRAPH FINAL part358H Conopco, Inc. d/b/a Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1486_2f3d1b50-14f6-4410-b277-d57a6834373a 64942-1486 HUMAN OTC DRUG Dove Dermacare Scalp Dryness and Itch Relief Anti-Dandruff Conditioner Pyrithione Zinc LIQUID TOPICAL 20161110 OTC MONOGRAPH FINAL part358H Conopco, Inc. d/b/a/ Unilever PYRITHIONE ZINC .5 g/100mL N 20181231 64942-1487_0ff78a7c-ed8a-41ea-af7b-5ad6c614e29b 64942-1487 HUMAN OTC DRUG Dove Dermacare Scalp Dryness and Itch Relief Anti-Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20161110 OTC MONOGRAPH FINAL part358H Conopco, Inc. d/b/a/ Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1488_e637afca-0234-48ee-ac61-9c6767ea213c 64942-1488 HUMAN OTC DRUG Dove Dermacare Scalp Invigorating Mint Anti-Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20161110 OTC MONOGRAPH FINAL part358H Conopco, Inc. d/b/a/ Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1489_c5189885-444e-4ee9-b262-32d75940541b 64942-1489 HUMAN OTC DRUG Dove Dermacare Scalp Invigorating Mint 2 In 1 Anti-Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20161110 OTC MONOGRAPH FINAL part358H Conopco, Inc. d/b/a/ Unilever PYRITHIONE ZINC 1 g/100mL N 20181231 64942-1490_82235a88-d9ab-4380-8e8e-5e6aaad3533e 64942-1490 HUMAN OTC DRUG Dove Advanced Care Cool Essentials Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20140115 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1491_4f522627-5222-441d-a6d2-fd654d5d436e 64942-1491 HUMAN OTC DRUG Dove Men plus Care Invisible Fresh Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20161109 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1492_ff6ed639-98c4-426a-bd94-15542d5d78e6 64942-1492 HUMAN OTC DRUG Degree Men MotionSense Ultraclear Black and White Driftwood 48H Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20170707 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1493_f514d838-8dd2-456f-8f49-41e5c25077bc 64942-1493 HUMAN OTC DRUG Degree Men MotionSense Ultraclear Black and White Ocean Air 48H Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20170707 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1494_364cb256-2340-47d1-b047-f90c914e8b2e 64942-1494 HUMAN OTC DRUG Degree MotionSense Ultraclear Black and White Tropical Touch 48H Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20170707 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1495_74c4e832-42fc-4c0d-86bb-41e33b90368b 64942-1495 HUMAN OTC DRUG Degree MotionSense Ultraclear Black and White Pure Rain 48H Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20170707 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1496_559efa5b-917c-2b52-e054-00144ff88e88 64942-1496 HUMAN OTC DRUG Degree Men MotionSense Ultraclear Black and White Driftwood 48H Antiperspirant STICK TOPICAL 20170731 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1497_559f5ad0-5ec1-401d-e054-00144ff88e88 64942-1497 HUMAN OTC DRUG Degree Men MotionSense Ultraclear Black and White Ocean Air 48H Antiperspirant STICK TOPICAL 20170731 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1498_559fa71f-f9d6-55e8-e054-00144ff8d46c 64942-1498 HUMAN OTC DRUG Degree MotionSense Ultraclear Black and White Pure Rain Invisible Solid 48H Antiperspirant STICK TOPICAL 20170731 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1499_559ff7bd-fc6f-5406-e054-00144ff88e88 64942-1499 HUMAN OTC DRUG Degree MotionSense Ultraclear Black and White Tropical Touch Invisible Solid 48H Antiperspirant STICK TOPICAL 20170731 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1500_5629e808-5eed-4d33-e054-00144ff8d46c 64942-1500 HUMAN OTC DRUG Degree Men MotionSense Advanced Protection Extreme Blast 48H Antiperspirant STICK TOPICAL 20170731 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1501_562ecd66-d769-5a00-e054-00144ff8d46c 64942-1501 HUMAN OTC DRUG Degree Men MotionSense Advanced Protection Clean 48H Antiperspirant STICK TOPICAL 20170731 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1502_cbcdfcba-8a6b-4467-aa3a-9d051efcaed7 64942-1502 HUMAN OTC DRUG Dove DermaSeries Dry Skin Relief Replenishing Face Cream SPF 15 Avobenzone,Ensulizole, Octisalate, Octocrylene CREAM TOPICAL 20170712 OTC MONOGRAPH NOT FINAL part352 Conopco, Inc. d/b/a Unilever AVOBENZONE; ENSULIZOLE; OCTISALATE; OCTOCRYLENE 2; 1.5; 5; 1.3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 64942-1503_9f8c14de-dcec-41a6-a207-567dc5eef912 64942-1503 HUMAN OTC DRUG Dove DermaSeries Eczema Relief Soothing Body Colloidal Oatmeal LOTION TOPICAL 20170713 OTC MONOGRAPH FINAL part347 Conopco, Inc. d/b/a/ Unilever OATMEAL 1 g/100mL N 20181231 64942-1504_57629a1a-dee7-7ba7-e053-2991aa0aa76d 64942-1504 HUMAN OTC DRUG Dove Invisible Crystal Touch Dry Spray 48H Antiperspirant AEROSOL, SPRAY TOPICAL 20170822 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1505_57637504-99d3-4554-e053-2991aa0a6473 64942-1505 HUMAN OTC DRUG Dove Lavender Fresh Dry Spray 48H Antiperspirant AEROSOL, SPRAY TOPICAL 20170822 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1506_5762f45f-aec4-f98f-e053-2991aa0a1c81 64942-1506 HUMAN OTC DRUG Dove Invisible Sheer Cool Dry Spray 48H Antiperspirant AEROSOL, SPRAY TOPICAL 20170822 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1507_589f262d-1cfb-d814-e053-2a91aa0a426c 64942-1507 HUMAN OTC DRUG Axe Gold Original Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20170907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1508_5898fb2b-79dc-0641-e053-2991aa0ae2d3 64942-1508 HUMAN OTC DRUG Dove Go Fresh Rejuvenate 48H Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20170907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1509_589e844d-447d-6460-e053-2a91aa0ad11f 64942-1509 HUMAN OTC DRUG Dove GClear Tone Pink Rosa Dry Spray 48H Antiperspirant AEROSOL, SPRAY TOPICAL 20170907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1510_58b96033-2638-f939-e053-2991aa0a1354 64942-1510 HUMAN OTC DRUG Dove Men plus Care Stain Defense Cool 48H Dry Sray Antiperspirant AEROSOL, SPRAY TOPICAL 20170907 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1511_58ef2d15-10d2-1364-e053-2991aa0aba93 64942-1511 HUMAN OTC DRUG Axe Gold Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20170911 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1512_58efab97-8c33-3dc5-e053-2991aa0ac14b 64942-1512 HUMAN OTC DRUG Axe Forest Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20170911 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1513_58f021e3-d540-78bc-e053-2a91aa0ad6ad 64942-1513 HUMAN OTC DRUG Axe Night Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20170911 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1514_58fd5571-37c9-7f10-e053-2991aa0afdce 64942-1514 HUMAN OTC DRUG Axe Axe Charge Up Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20170911 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1515_58fde3bb-e97e-0a04-e053-2a91aa0a8faa 64942-1515 HUMAN OTC DRUG Dove Men plus Care Stain Defense Clean 48H Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20170912 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1516_58ff33e1-a492-5efc-e053-2991aa0a9eb7 64942-1516 HUMAN OTC DRUG Dove Men plus Care Stain Defense Fresh 48H Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20170912 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20181231 64942-1517_58fde383-6972-d110-e053-2991aa0ad904 64942-1517 HUMAN OTC DRUG Axe Gold Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20170911 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1518_58fd5571-37d9-7f10-e053-2991aa0afdce 64942-1518 HUMAN OTC DRUG Axe Forest Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20170911 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1519_58fd0b00-9d41-6441-e053-2991aa0a3af9 64942-1519 HUMAN OTC DRUG Axe Night Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20170911 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1520_5919ba61-7dcb-3a3d-e053-2991aa0a4895 64942-1520 HUMAN OTC DRUG Axe Gold Oud Wood and Dark Vanilla Antiperspirant STICK TOPICAL 20170913 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1521_59255405-3218-2060-e053-2991aa0ac3b7 64942-1521 HUMAN OTC DRUG Axe Gold Fresh Iced Mint and Leather Antiperspirant STICK TOPICAL 20170913 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1522_5928e978-4e6a-55a4-e053-2991aa0afd69 64942-1522 HUMAN OTC DRUG Axe Gold Original Antiperspirant STICK TOPICAL 20170914 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1523_592b1faa-7282-e1f2-e053-2991aa0a2c65 64942-1523 HUMAN OTC DRUG Dove Advanced Care Invisible Crystal Touch 48H Antiperspirant STICK TOPICAL 20170914 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1524_59781535-29ca-e64d-e053-2a91aa0adfcd 64942-1524 HUMAN OTC DRUG Dove Dove Advanced Care Invisible Sheer Cool 48H Antiperspirant STICK TOPICAL 20170918 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1525_59796a18-eeec-396e-e053-2991aa0af46a 64942-1525 HUMAN OTC DRUG Dove Advanced Care Go Fresh Rejuvenate 48H Antiperspirant STICK TOPICAL 20170918 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 64942-1526_597db328-672e-f2ec-e053-2991aa0a2436 64942-1526 HUMAN OTC DRUG Dove Men plus Care Stain Defense Cool 48H Antiperspirant STICK TOPICAL 20170918 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1527_5993790e-9166-b169-e053-2991aa0a1653 64942-1527 HUMAN OTC DRUG Dove Men plus Care Stain Defense Clean 48H Antiperspirant STICK TOPICAL 20170919 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1528_59942baa-5534-4a60-e053-2991aa0a249a 64942-1528 HUMAN OTC DRUG Dove Men plus Care Stain Defense Fresh 48H Antiperspirant STICK TOPICAL 20170919 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1529_59942baa-553c-4a60-e053-2991aa0a249a 64942-1529 HUMAN OTC DRUG Axe Men plus Care Stain Defense Fresh 48H Antiperspirant STICK TOPICAL 20170919 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1530_59a15535-b196-670a-e053-2991aa0aecf9 64942-1530 HUMAN OTC DRUG Axe Anarchy Antiperspirant and Deodorant STICK TOPICAL 20170920 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1531_59b66cce-c06e-6de6-e053-2a91aa0a6243 64942-1531 HUMAN OTC DRUG Axe Dark Temptation Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170921 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1532_59b86f6e-7c05-2dbc-e053-2a91aa0a792c 64942-1532 HUMAN OTC DRUG Axe Apollo Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170921 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1533_5a1a1c9b-c208-9261-e053-2991aa0a02fd 64942-1533 HUMAN OTC DRUG Axe Black Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170926 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1534_5a1a9284-749b-3c88-e053-2991aa0a6434 64942-1534 HUMAN OTC DRUG Axe Black Chill Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170926 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1535_5a1b0f9d-b9f5-6f30-e053-2991aa0acc64 64942-1535 HUMAN OTC DRUG Axe Black Eclipse Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170926 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1536_5a1bdc9a-2ed1-514a-e053-2991aa0a8250 64942-1536 HUMAN OTC DRUG Axe Gold Temptation Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170926 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1537_5a1ce60e-9781-1801-e053-2a91aa0adb5e 64942-1537 HUMAN OTC DRUG Axe You Got Something Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170926 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1538_5a1d6061-9c9a-6e70-e053-2a91aa0a5366 64942-1538 HUMAN OTC DRUG Axe Essence Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170926 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1539_5a2e9a41-0a96-3baf-e053-2a91aa0a082e 64942-1539 HUMAN OTC DRUG Axe Phoenix Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170927 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1540_5a2e98a1-caa7-4235-e053-2991aa0ab7a3 64942-1540 HUMAN OTC DRUG Axe Kilo Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170927 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1541_5a30d148-c891-5ece-e053-2a91aa0a623a 64942-1541 HUMAN OTC DRUG Axe Advanced Protection Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170927 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1542_5a35075b-bcb1-ec7d-e053-2991aa0a4f6b 64942-1542 HUMAN OTC DRUG Axe Night Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170927 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1543_5a35ee5e-7c09-976f-e053-2991aa0af5f0 64942-1543 HUMAN OTC DRUG Axe Forest Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170927 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1544_5a358252-9a57-c3e1-e053-2a91aa0a6751 64942-1544 HUMAN OTC DRUG Axe Island Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170927 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1545_5a35ee5e-7c3b-976f-e053-2991aa0af5f0 64942-1545 HUMAN OTC DRUG Axe Gold Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170927 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 11.4 g/100g N 20181231 64942-1546_5a36cd0d-338d-265a-e053-2991aa0a6886 64942-1546 HUMAN OTC DRUG Axe Charge Up Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170927 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 64942-1547_5a5f8b8e-0f5d-6c0c-e053-2991aa0aa688 64942-1547 HUMAN OTC DRUG Degree Men MotionSense Extreme Blast 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170929 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1548_5a7199de-e3ec-c716-e053-2991aa0adc19 64942-1548 HUMAN OTC DRUG Degree Men MotionSense Cool Rush 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170929 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1549_5a71eea4-cc0b-2c82-e053-2991aa0a4872 64942-1549 HUMAN OTC DRUG Degree Men MotionSense Sport Defense 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20170929 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1550_5b70ce41-0ed5-0993-e053-2a91aa0a5dcb 64942-1550 HUMAN OTC DRUG Degree Men MotionSense Everest 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20171013 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1551_5babc891-8fce-a31d-e053-2991aa0a229e 64942-1551 HUMAN OTC DRUG Degree Men Cool Rush 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20171016 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1552_5bad9f81-e43e-11ce-e053-2a91aa0a13e3 64942-1552 HUMAN OTC DRUG Degree Men Cool Comfort 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20171016 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1553_5baf71e1-246a-293d-e053-2a91aa0ab65a 64942-1553 HUMAN OTC DRUG Degree Men Sport 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20171016 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20181231 64942-1554_5bdc217a-c3c8-18e2-e053-2a91aa0a129e 64942-1554 HUMAN OTC DRUG Degree Men MotionSense Adventure 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20171018 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1555_5bffa4e3-b3f0-23ec-e053-2a91aa0a266b 64942-1555 HUMAN OTC DRUG Degree Men MotionSense Extreme 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20171020 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1556_5c0310f8-f796-5e08-e053-2a91aa0aced7 64942-1556 HUMAN OTC DRUG Degree Men MotionSense Overtime 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20171020 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1557_5c03805a-141f-55ef-e053-2a91aa0aade5 64942-1557 HUMAN OTC DRUG Degree Men MotionSense Active Shield 48H Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20171020 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 64942-1558_5c4cb241-187b-7af8-e053-2a91aa0ace3b 64942-1558 HUMAN OTC DRUG Degree Men Sport 48H Antiperspirant Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20171024 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 19.1 g/100g N 20181231 64942-1559_5e8a1f93-9856-e3cc-e053-2991aa0ada19 64942-1559 HUMAN OTC DRUG Dove Powder 24h Invisible Solid AntiPerspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20171121 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 22 g/100mL N 20181231 64942-1560_5e89ba53-8db7-17d1-e053-2a91aa0a701e 64942-1560 HUMAN OTC DRUG Suave Powder 24 Hour Protection Roll-On AntiPerspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20171121 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 22 g/100mL N 20181231 64942-1561_5f23de9c-6bbf-a9ce-e053-2991aa0ada53 64942-1561 HUMAN OTC DRUG Axe Apollo Dry Spray Antiperspirant 48HR Protection Dry AEROSOL, SPRAY TOPICAL 20171129 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1562_5f25d52c-333c-f3d0-e053-2a91aa0a3a82 64942-1562 HUMAN OTC DRUG Axe Black Dry Spray Antiperspirant 48HR Protection Dry 48HR Protection Dry AEROSOL, SPRAY TOPICAL 20171129 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1563_5f27fadb-060a-3640-e053-2991aa0a9b78 64942-1563 HUMAN OTC DRUG Axe Dark Temptation Dry Spray Antiperspirant 48HR Protection Dry AEROSOL, SPRAY TOPICAL 20171129 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20181231 64942-1564_63eb6bc6-b45e-eb4b-e053-2991aa0a8191 64942-1564 HUMAN OTC DRUG Axe Black Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20180201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20191231 64942-1565_6412f3e0-ea47-7c80-e053-2a91aa0ad2f3 64942-1565 HUMAN OTC DRUG Axe Apollo Dry Spray Antiperspirant 48HR Protection Dry AEROSOL, SPRAY TOPICAL 20180131 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20191231 64942-1566_6414a97c-6631-4c58-e053-2991aa0a704b 64942-1566 HUMAN OTC DRUG Dove Cool Essentials Dry Spray 48H Antiperspirant AEROSOL, SPRAY TOPICAL 20180131 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20191231 64942-1567_641578cc-9831-6046-e053-2a91aa0a0076 64942-1567 HUMAN OTC DRUG Dove Men plus Care Clean Comfort Dry Spray 48H Antiperspirant AEROSOL, SPRAY TOPICAL 20180131 OTC MONOGRAPH FINAL part350 Conopco, Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20191231 64942-1568_6418350c-b5c0-badb-e053-2991aa0a4db6 64942-1568 HUMAN OTC DRUG Degree MotionSense Ultraclear Black and White Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20180131 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20191231 64942-1569_641d6e42-b5f6-34a4-e053-2a91aa0acef9 64942-1569 HUMAN OTC DRUG Degree Men MotionSense Ultraclear Black and White Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20180131 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 20.2 g/100g N 20191231 64942-1570_64516779-0353-fd0a-e053-2a91aa0a5f2f 64942-1570 HUMAN OTC DRUG Axe Phoenix Dry Spray Antiperspirant 48HR Protection Dry AEROSOL, SPRAY TOPICAL 20180203 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20191231 64942-1571_6426f263-bebd-0f43-e053-2991aa0a8041 64942-1571 HUMAN OTC DRUG Degree MotionSense Grapefruit and Verbena Scent Dry Spray Antiperspirant AEROSOL, SPRAY TOPICAL 20180201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a Unilever ALUMINUM CHLOROHYDRATE 23.3 g/100g N 20191231 64942-1572_642bcf90-08bb-08b1-e053-2a91aa0ac56f 64942-1572 HUMAN OTC DRUG Degree MotionSense Grapefruit and Verbena Scent Antiperspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20180201 OTC MONOGRAPH FINAL part350 Conopco Inc. d/b/a/ Unilever ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18.2 g/100g N 20191231 64944-0001_7d7eb52d-bfb7-42c6-8541-1ddadab353da 64944-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990319 UNAPPROVED MEDICAL GAS Seventh Street Medical Supply, Inc OXYGEN 99 L/100L E 20171231 64950-230_f4bb764f-297f-4b7a-bf57-0e43e236c2ae 64950-230 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20140401 ANDA ANDA065422 Genus Lifescience Inc. NYSTATIN 100000 [USP'U]/15mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 64950-231_2fb36740-2b6a-4d72-ba36-0317889b9ad3 64950-231 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20140401 ANDA ANDA040610 Genus Lifesciences Inc. PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 64950-340_37133980-bcf2-4b2f-95dc-39c2fa91f0bc 64950-340 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 20140401 ANDA ANDA200343 Genus Lifesciences Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 64950-353_2abf68f7-31a9-4370-86e2-0e1bc3f20305 64950-353 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20101020 NDA NDA200535 Genus Lifesciences Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 64950-354_2abf68f7-31a9-4370-86e2-0e1bc3f20305 64950-354 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20130909 NDA NDA200535 Genus Lifesciences Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 64950-359_5e9b766e-0035-4018-b6f7-868571de6af0 64950-359 HUMAN PRESCRIPTION DRUG GOPRELTO cocaine hydrochloride SOLUTION NASAL 20180108 NDA NDA209963 Genus Lifesciences Inc. COCAINE HYDROCHLORIDE 40 mg/mL CII N 20181231 64950-901_c0c0e50a-90e3-4b86-b13d-65623fa2b46e 64950-901 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20101020 NDA NDA200534 Genus Lifesciences Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 64952-001_617e61a9-0191-0d4e-e053-2a91aa0a3d09 64952-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19861124 NDA NDA205889 T J Nowak Supply Co Inc OXYGEN 99 L/L N 20181231 64960-000_44ab1122-a325-4576-93eb-23b6ba406783 64960-000 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130730 UNAPPROVED MEDICAL GAS King's Daughters Home Medical Equipment OXYGEN 1 L/L N 20181231 64980-104_d7fd9459-7abd-4019-8830-a61abb93b4ce 64980-104 HUMAN PRESCRIPTION DRUG Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate TABLET ORAL 20120628 UNAPPROVED DRUG OTHER Rising Pharmaceuticals, Inc. SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 852; 155; 130 mg/1; mg/1; mg/1 N 20181231 64980-133_20d311f1-430f-48b7-be0e-b5964118e397 64980-133 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20070805 ANDA ANDA040733 Rising Pharmaceuticals, Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 64980-134_20d311f1-430f-48b7-be0e-b5964118e397 64980-134 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20070213 ANDA ANDA040733 Rising Pharmaceuticals, Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 64980-135_20d311f1-430f-48b7-be0e-b5964118e397 64980-135 HUMAN PRESCRIPTION DRUG DIPYRIDAMOLE DIPYRIDAMOLE TABLET, FILM COATED ORAL 20070213 ANDA ANDA040733 Rising Pharmaceuticals, Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 64980-149_3db62f3e-5439-4710-a4ca-cce886108964 64980-149 HUMAN PRESCRIPTION DRUG Probenecid and Colchicine Probenecid and Colchicine TABLET ORAL 20080513 ANDA ANDA040618 Rising Pharmaceuticals, Inc. PROBENECID; COLCHICINE 500; .5 mg/1; mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20181231 64980-151_b66c6a8c-914f-4ce4-a168-00d362cd0c38 64980-151 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL 20090501 ANDA ANDA079133 Rising Pharmaceuticals, Inc AMILORIDE HYDROCHLORIDE 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 64980-157_ea933bba-b3f6-4d37-8c23-d75d0c5cedc2 64980-157 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20100723 ANDA ANDA091004 Rising Pharamceuticals, Inc ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 64980-158_cfa7bf92-274c-478e-ad74-910fa7d21512 64980-158 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET, FILM COATED ORAL 20100611 ANDA ANDA090462 Rising Pharmaceuticals, Inc PROTRIPTYLINE HYDROCHLORIDE 5 mg/1 Tricyclic Antidepressant [EPC] N 20181231 64980-159_cfa7bf92-274c-478e-ad74-910fa7d21512 64980-159 HUMAN PRESCRIPTION DRUG Protriptyline Hydrochloride Protriptyline Hydrochloride TABLET, FILM COATED ORAL 20100611 ANDA ANDA090462 Rising Pharmaceuticals, Inc PROTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 64980-160_0f85faea-c7b6-4ea2-a5b4-08fb5daa4fd8 64980-160 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100824 ANDA ANDA091256 Rising Pharmaceuticals Inc. BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 64980-161_0f85faea-c7b6-4ea2-a5b4-08fb5daa4fd8 64980-161 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100406 ANDA ANDA091256 Rising Pharmaceuticals Inc. BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 64980-162_0f85faea-c7b6-4ea2-a5b4-08fb5daa4fd8 64980-162 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100406 ANDA ANDA091256 Rising Pharmaceuticals Inc. BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 64980-163_0f85faea-c7b6-4ea2-a5b4-08fb5daa4fd8 64980-163 HUMAN PRESCRIPTION DRUG BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET ORAL 20100406 ANDA ANDA091256 Rising Pharmaceuticals Inc. BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 64980-169_6491d5b0-7f1b-4ac0-8791-308401000e4d 64980-169 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 Rising Pharmaceuticals Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 64980-170_6491d5b0-7f1b-4ac0-8791-308401000e4d 64980-170 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 Rising Pharmaceuticals Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 64980-171_9bd05731-ba84-41f4-baca-ad5d1feebe0f 64980-171 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20110408 ANDA ANDA091619 Rising Pharmaceuticals, Inc. DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 64980-172_9bd05731-ba84-41f4-baca-ad5d1feebe0f 64980-172 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20110408 ANDA ANDA091619 Rising Pharmaceuticals, Inc. DISULFIRAM 500 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 64980-174_760324b8-5d15-44b0-a77d-7203f653a21d 64980-174 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20100701 ANDA ANDA040823 Rising Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 64980-175_9d8b08a9-02c8-4b02-9e0e-a24b90d7a7e0 64980-175 HUMAN PRESCRIPTION DRUG CARISOPRODOL and ASPIRIN CARISOPRODOL and ASPIRIN TABLET ORAL 20100107 ANDA ANDA040832 Rising Pharmaceuticals, Inc. CARISOPRODOL; ASPIRIN 200; 325 mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE] E 20171231 64980-176_cbe427b8-c405-4343-af60-c140e2a85884 64980-176 HUMAN PRESCRIPTION DRUG Carisoprodol, Aspirin and Codeine Phosphate Carisoprodol, Aspirin and Codeine Phosphate TABLET ORAL 20100110 ANDA ANDA040860 Rising Pharmaceuticals, Inc. CARISOPRODOL; ASPIRIN; CODEINE PHOSPHATE 200; 325; 16 mg/1; mg/1; mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 64980-177_a0130073-fcf3-4962-9de3-a27ea9f7bc58 64980-177 HUMAN PRESCRIPTION DRUG Chloroquine Phosphate Chloroquine Phosphate TABLET ORAL 20110701 ANDA ANDA091621 Rising Pharmaceuticals, Inc. CHLOROQUINE PHOSPHATE 250 mg/1 Antimalarial [EPC] N 20181231 64980-178_885a38e1-284e-4b06-bc13-4b428b4cbd41 64980-178 HUMAN PRESCRIPTION DRUG Chloroquine Phosphate Chloroquine Phosphate TABLET ORAL 20110701 ANDA ANDA090612 Rising Pharmaceuticals, Inc. CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] N 20181231 64980-179_62477eaf-9918-1295-e053-2991aa0a256f 64980-179 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20111103 ANDA ANDA201566 Rising Pharmaceuticals, Inc. FLUCYTOSINE 250 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20191231 64980-180_62477eaf-9918-1295-e053-2991aa0a256f 64980-180 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20111103 ANDA ANDA201566 Rising Pharmaceuticals, Inc. FLUCYTOSINE 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20191231 64980-181_5a68ac1c-94bd-4583-8c87-38618bd3f2a0 64980-181 HUMAN PRESCRIPTION DRUG DIFLUNISAL DIFLUNISAL TABLET, FILM COATED ORAL 20120501 ANDA ANDA202845 Rising Pharmaceuticals Inc. DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 64980-182_0ed99c62-aec3-4f3f-acb3-bd43c9d7ed4d 64980-182 HUMAN OTC DRUG Sodium Bicarbonate sodium bicarbonate TABLET, ORALLY DISINTEGRATING ORAL 20120626 OTC MONOGRAPH FINAL part331 Rising Pharmaceuticals, Inc. SODIUM BICARBONATE 650 mg/1 E 20171231 64980-183_f1959810-01c4-4cfd-a729-97d7b37d6654 64980-183 HUMAN PRESCRIPTION DRUG Tranylcypromine Sulfate tranylcypromine sulfate TABLET ORAL 20120109 NDA NDA012342 Rising Pharmaceuticals, Inc. TRANYLCYPROMINE SULFATE 10 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 64980-184_22d339ea-953f-4ef5-8f40-e3c2c7f41861 64980-184 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET ORAL 20121115 ANDA ANDA202545 Rising Pharmaceuticals, Inc GRISEOFULVIN 125 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 64980-185_22d339ea-953f-4ef5-8f40-e3c2c7f41861 64980-185 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET ORAL 20121115 ANDA ANDA202545 Rising Pharmaceuticals, Inc GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 64980-186_7a7e6024-fcb1-4e9a-8de4-30d7c97210c0 64980-186 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET ORAL 20121206 ANDA ANDA202482 Rising Pharmaceuticals Inc. GRISEOFULVIN 500 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 64980-190_29007dc1-5294-4e93-b1f7-f253704e99cc 64980-190 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120921 ANDA ANDA091451 Rising Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 64980-191_e2d503ce-be79-4ccc-9b25-eb2428482b10 64980-191 HUMAN PRESCRIPTION DRUG Riluzole riluzole TABLET, FILM COATED ORAL 20130515 NDA AUTHORIZED GENERIC NDA020599 Rising Pharmaceuticals, Inc. RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] N 20181231 64980-194_c1b358b1-1a43-4d06-bede-6d96cdc45780 64980-194 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140320 NDA AUTHORIZED GENERIC NDA020033 Rising Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 64980-195_c1b358b1-1a43-4d06-bede-6d96cdc45780 64980-195 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140320 NDA AUTHORIZED GENERIC NDA020033 Rising Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 64980-196_c1b358b1-1a43-4d06-bede-6d96cdc45780 64980-196 HUMAN PRESCRIPTION DRUG benazepril hydrochloride and hydrochlorothiazide benazepril hydrochloride and hydrochlorothiazide TABLET ORAL 20140320 NDA AUTHORIZED GENERIC NDA020033 Rising Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 64980-203_26160057-97ac-4b8b-93a4-1d66a3b78a48 64980-203 HUMAN PRESCRIPTION DRUG Zolmitriptan zolmitriptan TABLET, FILM COATED ORAL 20160104 ANDA ANDA204232 Rising Pharmaceuticals, Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 64980-204_26160057-97ac-4b8b-93a4-1d66a3b78a48 64980-204 HUMAN PRESCRIPTION DRUG Zolmitriptan zolmitriptan TABLET, FILM COATED ORAL 20160104 ANDA ANDA204232 Rising Pharmaceuticals, Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 64980-205_40e68c50-0600-4d82-bd2a-6588241d1d90 64980-205 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20160202 ANDA ANDA204779 Rising Pharmaceuticals, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 64980-206_225e95e7-cbe2-4721-9371-10a73bdd5978 64980-206 HUMAN PRESCRIPTION DRUG Zileuton Zileuton TABLET, EXTENDED RELEASE ORAL 20170321 ANDA ANDA204929 Rising Pharmaceuticals, Inc. ZILEUTON 600 mg/1 5-Lipoxygenase Inhibitor [EPC],5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE] N 20181231 64980-209_9d036401-8cac-465f-aa8e-caed83604814 64980-209 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20160927 ANDA ANDA206121 Rising Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 64980-210_9d036401-8cac-465f-aa8e-caed83604814 64980-210 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20160927 ANDA ANDA206121 Rising Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 64980-211_9d036401-8cac-465f-aa8e-caed83604814 64980-211 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20160927 ANDA ANDA206121 Rising Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 64980-224_16b3d389-02d6-4281-bae0-7b9b26415645 64980-224 HUMAN PRESCRIPTION DRUG DUTASTERIDE dutasteride CAPSULE, LIQUID FILLED ORAL 20151120 ANDA ANDA202530 Rising Pharmaceuticals, Inc. DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 64980-225_ff73af35-b2d3-4297-bd2a-21fd98c12fb9 64980-225 HUMAN PRESCRIPTION DRUG Paricalcitol paricalcitol CAPSULE, GELATIN COATED ORAL 20151103 ANDA ANDA202124 Rising Pharmaceuticals, Inc. PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 64980-226_ff73af35-b2d3-4297-bd2a-21fd98c12fb9 64980-226 HUMAN PRESCRIPTION DRUG Paricalcitol paricalcitol CAPSULE, GELATIN COATED ORAL 20151103 ANDA ANDA202124 Rising Pharmaceuticals, Inc. PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 64980-227_ff73af35-b2d3-4297-bd2a-21fd98c12fb9 64980-227 HUMAN PRESCRIPTION DRUG Paricalcitol paricalcitol CAPSULE, GELATIN COATED ORAL 20151103 ANDA ANDA202124 Rising Pharmaceuticals, Inc. PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 64980-228_4774de14-3235-45ff-8d0c-44cb224800cf 64980-228 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20160909 ANDA ANDA201518 Rising Pharmaceuticals, Inc. DOXERCALCIFEROL .5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 64980-229_4774de14-3235-45ff-8d0c-44cb224800cf 64980-229 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20160909 ANDA ANDA201518 Rising Pharmaceuticals, Inc. DOXERCALCIFEROL 1 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 64980-230_4774de14-3235-45ff-8d0c-44cb224800cf 64980-230 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20160909 ANDA ANDA201518 Rising Pharmaceuticals, Inc. DOXERCALCIFEROL 2.5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 64980-235_0e31a067-d128-4d12-8e76-84cb2519ca3a 64980-235 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20160222 ANDA ANDA205245 Rising Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 64980-236_0e31a067-d128-4d12-8e76-84cb2519ca3a 64980-236 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20160222 ANDA ANDA205245 Rising Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 64980-255_bb5c0dc8-9fca-4a1a-88e3-6e38e5f30590 64980-255 HUMAN PRESCRIPTION DRUG Budesonide budesonide CAPSULE ORAL 20170830 ANDA ANDA207367 Rising Pharmaceuticals, Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 64980-256_171c4eed-1a6d-4b12-b9af-967b124d51d8 64980-256 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20170413 ANDA ANDA205074 Rising Pharmaceuticals, Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 64980-257_171c4eed-1a6d-4b12-b9af-967b124d51d8 64980-257 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20170413 ANDA ANDA205074 Rising Pharmaceuticals, Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 64980-258_38794f88-ff0c-45d9-93cc-134115a897c7 64980-258 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20081229 ANDA ANDA040821 Rising Pharmaceuticals, Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 64980-259_38794f88-ff0c-45d9-93cc-134115a897c7 64980-259 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20081229 ANDA ANDA040821 Rising Pharmaceuticals, Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 64980-260_46e99ec1-2907-4f19-b5a0-3408033286b2 64980-260 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20150928 ANDA ANDA040350 Rising Pharmaceuticals, Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 64980-261_46e99ec1-2907-4f19-b5a0-3408033286b2 64980-261 HUMAN PRESCRIPTION DRUG Methimazole methimazole TABLET ORAL 20150928 ANDA ANDA040350 Rising Pharmaceuticals, Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 64980-272_32ffba09-c0af-4d03-bcd2-81059f92118a 64980-272 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20160718 ANDA ANDA040653 Rising Pharmaceuticals, Inc. GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 64980-273_32ffba09-c0af-4d03-bcd2-81059f92118a 64980-273 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20160718 ANDA ANDA040653 Rising Pharmaceuticals, Inc. GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 64980-274_1deaf237-c8ee-4895-9e7c-88fa4d4a9635 64980-274 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20161207 ANDA ANDA206762 Rising Pharmaceuticals, Inc. VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 64980-275_1deaf237-c8ee-4895-9e7c-88fa4d4a9635 64980-275 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20161207 ANDA ANDA206762 Rising Pharmaceuticals, Inc. VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 64980-276_22d34135-755d-478b-95f8-e439dfa17574 64980-276 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20170201 ANDA ANDA207456 Rising Pharmaceuticals, Inc. CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 64980-277_22d34135-755d-478b-95f8-e439dfa17574 64980-277 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20170201 ANDA ANDA207456 Rising Pharmaceuticals, Inc. CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 64980-278_21a1c4f9-d773-42c1-bd70-e367c0a017e7 64980-278 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20171201 ANDA ANDA205663 Rising Pharmaceuticals, Inc. LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] N 20181231 64980-279_1c3ed415-b8b5-4475-ba04-652d8488e155 64980-279 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170424 ANDA ANDA204720 Rising Pharmaceuticals, Inc. GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 64980-280_1c3ed415-b8b5-4475-ba04-652d8488e155 64980-280 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170424 ANDA ANDA204720 Rising Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 64980-281_1c3ed415-b8b5-4475-ba04-652d8488e155 64980-281 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170424 ANDA ANDA204720 Rising Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 64980-294_14c66789-e9c9-42fd-ae3b-a1eee8453566 64980-294 HUMAN OTC DRUG Sodium Bicarbonate sodium bicarbonate TABLET, ORALLY DISINTEGRATING ORAL 20170201 OTC MONOGRAPH FINAL part331 Rising Pharmaceuticals, Inc. SODIUM BICARBONATE 650 mg/1 N 20181231 64980-301_0c61d2ad-0795-455a-a720-a81df1a0b0e4 64980-301 HUMAN PRESCRIPTION DRUG Proctozone HC hydrocortisone CREAM TOPICAL 20120501 ANDA ANDA089682 Rising Pharmaceuticals, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 64980-302_384f2adf-43c5-410b-8a1e-d856ac3d8a17 64980-302 HUMAN PRESCRIPTION DRUG Procto-Pak hydrocortisone CREAM TOPICAL 20120601 ANDA ANDA087795 Rising Pharmaceuticals, Inc. HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 64980-303_7755d902-6a64-4f69-852d-71a59ef017b5 64980-303 HUMAN PRESCRIPTION DRUG CHLORTHALIDONE CHLORTHALIDONE TABLET ORAL 20170517 ANDA ANDA206904 Rising Pharmaceuticals, Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 64980-304_7755d902-6a64-4f69-852d-71a59ef017b5 64980-304 HUMAN PRESCRIPTION DRUG CHLORTHALIDONE CHLORTHALIDONE TABLET ORAL 20170517 ANDA ANDA206904 Rising Pharmaceuticals, Inc. CHLORTHALIDONE 50 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 64980-305_602c5345-5f9f-4155-b348-2754e836029b 64980-305 HUMAN PRESCRIPTION DRUG Denta 5000 Plus Sodium fluoride GEL, DENTIFRICE ORAL 20120713 UNAPPROVED DRUG OTHER Rising Pharmaceuticals, Inc. SODIUM FLUORIDE 1.1 g/100g N 20181231 64980-306_602c5345-5f9f-4155-b348-2754e836029b 64980-306 HUMAN PRESCRIPTION DRUG Denta 5000 Plus Sodium fluoride GEL, DENTIFRICE ORAL 20120713 UNAPPROVED DRUG OTHER Rising Pharmaceuticals, Inc. SODIUM FLUORIDE 1.1 g/100g N 20181231 64980-307_944faa31-3f0e-42cd-aa5f-22cd8ed1c131 64980-307 HUMAN PRESCRIPTION DRUG DentaGel Sodium fluoride GEL ORAL 20120501 UNAPPROVED DRUG OTHER Rising Pharmaceuticals, Inc. SODIUM FLUORIDE 1.1 g/100g N 20181231 64980-320_dcd88218-c233-4773-b327-f9151b38aa10 64980-320 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE TOPICAL 20100707 ANDA ANDA040771 Rising Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 64980-324_55af05d7-67f6-4c02-9dda-978739b29c87 64980-324 HUMAN PRESCRIPTION DRUG PROCTOZONE-HC Hydrocortisone 2.5% CREAM TOPICAL 20150803 ANDA ANDA040879 Rising Pharmaceuticals, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 64980-326_25d2d1ed-f3bb-45a8-a2e1-fbafc10bf6bb 64980-326 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone GEL TOPICAL 20160812 ANDA ANDA204675 Rising Pharmaceuticals, Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 64980-327_d20fd849-b5e2-4558-95de-80d208055d44 64980-327 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20161201 ANDA ANDA204675 Rising Pharmaceuticals, Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 64980-328_021902eb-867e-4769-9826-572d7d00dc67 64980-328 HUMAN PRESCRIPTION DRUG Erythromycin and Benzoyl Peroxide Erythromycin and Benzoyl Peroxide GEL TOPICAL 20161018 ANDA ANDA065385 Rising Pharmaceuticals, Inc. ERYTHROMYCIN; BENZOYL PEROXIDE 30; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 64980-329_9e46bc4c-2918-4b0c-8127-25c5778ca82b 64980-329 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Oil Fluocinolone Acetonide Oil OIL AURICULAR (OTIC) 20160914 ANDA ANDA203378 Rising Pharmaceuticals, Inc. FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 64980-330_735203cd-25f9-434a-86a0-0ea4074517a2 64980-330 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Oil Fluocinolone Acetonide OIL TOPICAL 20160718 ANDA ANDA090982 Rising Pharmaceuticals, Inc. FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 64980-331_235e83a9-f87c-47eb-8548-716f00fe6d90 64980-331 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Oil Fluocinolone Acetonide OIL TOPICAL 20160718 ANDA ANDA203377 Rising Pharmaceuticals, Inc. FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 64980-333_1c22f9d0-ae27-4e69-8b33-e634071128e8 64980-333 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE temozolomide CAPSULE ORAL 20170317 ANDA ANDA206309 Rising Pharmaceuticals, Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 64980-334_1c22f9d0-ae27-4e69-8b33-e634071128e8 64980-334 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE temozolomide CAPSULE ORAL 20170317 ANDA ANDA206309 Rising Pharmaceuticals, Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 64980-335_1c22f9d0-ae27-4e69-8b33-e634071128e8 64980-335 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE temozolomide CAPSULE ORAL 20170317 ANDA ANDA206309 Rising Pharmaceuticals, Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 64980-336_1c22f9d0-ae27-4e69-8b33-e634071128e8 64980-336 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE temozolomide CAPSULE ORAL 20170317 ANDA ANDA206309 Rising Pharmaceuticals, Inc. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 64980-337_1c22f9d0-ae27-4e69-8b33-e634071128e8 64980-337 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE temozolomide CAPSULE ORAL 20170317 ANDA ANDA206309 Rising Pharmaceuticals, Inc. TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 64980-338_1c22f9d0-ae27-4e69-8b33-e634071128e8 64980-338 HUMAN PRESCRIPTION DRUG TEMOZOLOMIDE temozolomide CAPSULE ORAL 20170317 ANDA ANDA206309 Rising Pharmaceuticals, Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 64980-340_ffdd2496-d253-419b-85a6-8c615f7545f1 64980-340 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 Rising Pharmaceuticals, Inc. ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 64980-341_ffdd2496-d253-419b-85a6-8c615f7545f1 64980-341 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 Rising Pharmaceuticals, Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 64980-342_ffdd2496-d253-419b-85a6-8c615f7545f1 64980-342 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 Rising Pharmaceuticals, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 64980-349_d5c46506-a350-44a1-9440-d939da895f16 64980-349 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20171107 ANDA ANDA091114 Rising Pharmaceuticals, Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 64980-350_d5c46506-a350-44a1-9440-d939da895f16 64980-350 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20171107 ANDA ANDA091114 Rising Pharmaceuticals, Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 64980-351_d5c46506-a350-44a1-9440-d939da895f16 64980-351 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20171107 ANDA ANDA091114 Rising Pharmaceuticals, Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 64980-354_1210d63d-e036-41c4-bbd4-027b9308205c 64980-354 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Rising Pharmaceuticals, Inc. STAVUDINE 15 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 64980-355_1210d63d-e036-41c4-bbd4-027b9308205c 64980-355 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Rising Pharmaceuticals, Inc. STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 64980-356_1210d63d-e036-41c4-bbd4-027b9308205c 64980-356 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Rising Pharmaceuticals, Inc. STAVUDINE 30 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 64980-357_1210d63d-e036-41c4-bbd4-027b9308205c 64980-357 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Rising Pharmaceuticals, Inc. STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 64980-362_5bd3d64a-46a3-41a0-bb89-23534bf168dd 64980-362 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Rising Pharmaceuticals, Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 64980-363_5bd3d64a-46a3-41a0-bb89-23534bf168dd 64980-363 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Rising Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 64980-364_5bd3d64a-46a3-41a0-bb89-23534bf168dd 64980-364 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Rising Pharmaceuticals, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 64980-365_5bd3d64a-46a3-41a0-bb89-23534bf168dd 64980-365 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Rising Pharmaceuticals, Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 64980-366_ee90c4dd-d780-415f-b988-d2ca2fe32386 64980-366 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Rising Pharmaceuticals, Inc. LEVOFLOXACIN 250 mg/1 N 20181231 64980-367_ee90c4dd-d780-415f-b988-d2ca2fe32386 64980-367 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Rising Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 64980-368_ee90c4dd-d780-415f-b988-d2ca2fe32386 64980-368 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Rising Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 64980-373_1cceab35-dc4a-40bc-a245-10b64820e217 64980-373 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Rising Pharmaceuticals, Inc. ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 64980-374_1cceab35-dc4a-40bc-a245-10b64820e217 64980-374 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Rising Pharmaceuticals, Inc. ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 64980-375_1cceab35-dc4a-40bc-a245-10b64820e217 64980-375 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Rising Pharmaceuticals, Inc. ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 64980-376_1cceab35-dc4a-40bc-a245-10b64820e217 64980-376 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Rising Pharmaceuticals, Inc. ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 64980-377_1cceab35-dc4a-40bc-a245-10b64820e217 64980-377 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Rising Pharmaceuticals, Inc. ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 64980-378_1cceab35-dc4a-40bc-a245-10b64820e217 64980-378 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Rising Pharmaceuticals, Inc. ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 64980-379_1cceab35-dc4a-40bc-a245-10b64820e217 64980-379 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Rising Pharmaceuticals, Inc. ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 64980-380_e5b6579b-505d-4cd1-8310-577f81674ad0 64980-380 HUMAN PRESCRIPTION DRUG carisoprodol carisoprodol TABLET ORAL 20161108 ANDA ANDA040792 Rising Pharmaceuticals, Inc. CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 64980-381_e5b6579b-505d-4cd1-8310-577f81674ad0 64980-381 HUMAN PRESCRIPTION DRUG carisoprodol carisoprodol TABLET ORAL 20090806 ANDA ANDA040792 Rising Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 64980-382_fe2ba786-3b59-4ef5-9cb9-8f932f58252f 64980-382 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20171107 ANDA ANDA203630 Rising Pharmaceuticals, Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 64980-383_fe2ba786-3b59-4ef5-9cb9-8f932f58252f 64980-383 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20171107 ANDA ANDA203630 Rising Pharmaceuticals, Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 64980-384_fe2ba786-3b59-4ef5-9cb9-8f932f58252f 64980-384 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20171107 ANDA ANDA203630 Rising Pharmaceuticals, Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 64980-385_a4cf687b-71f9-42f3-b18d-523f9cda9986 64980-385 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20171107 ANDA ANDA203081 Rising Pharmaceuticals, Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 64980-386_a4cf687b-71f9-42f3-b18d-523f9cda9986 64980-386 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20171107 ANDA ANDA203081 Rising Pharmaceuticals, Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 64980-387_a4cf687b-71f9-42f3-b18d-523f9cda9986 64980-387 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20171107 ANDA ANDA203081 Rising Pharmaceuticals, Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 64980-390_81ee1d2e-7520-4de1-b8ee-60186c11c3e4 64980-390 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20171107 ANDA ANDA078021 Rising Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 64980-391_81ee1d2e-7520-4de1-b8ee-60186c11c3e4 64980-391 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20171107 ANDA ANDA078021 Rising Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 64980-392_81ee1d2e-7520-4de1-b8ee-60186c11c3e4 64980-392 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20171107 ANDA ANDA078021 Rising Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 64980-396_a001e4a8-af4c-4dac-afe5-0743714c9fd4 64980-396 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20171107 ANDA ANDA203346 Rising Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 64980-397_a001e4a8-af4c-4dac-afe5-0743714c9fd4 64980-397 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20171107 ANDA ANDA203346 Rising Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 64980-398_a001e4a8-af4c-4dac-afe5-0743714c9fd4 64980-398 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20171107 ANDA ANDA203346 Rising Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 64980-399_a001e4a8-af4c-4dac-afe5-0743714c9fd4 64980-399 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20171107 ANDA ANDA203346 Rising Pharmaceuticals, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 64980-400_72d29b20-a0b3-43d8-802a-17bc973d14ea 64980-400 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20091104 ANDA ANDA090401 Rising Pharmaceuticals, Inc. LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 64980-401_72d29b20-a0b3-43d8-802a-17bc973d14ea 64980-401 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20091104 ANDA ANDA090401 Rising Pharmaceuticals, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 64980-402_edf589b2-f796-4522-a5e6-2bd0a833922f 64980-402 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20070608 ANDA ANDA065409 Rising Pharmaceuticals, Inc. CEFPODOXIME PROXETIL 50 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 64980-403_edf589b2-f796-4522-a5e6-2bd0a833922f 64980-403 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20070608 ANDA ANDA065409 Rising Pharmaceuticals, Inc. CEFPODOXIME PROXETIL 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 64980-406_a26cfa07-14a7-4468-8eed-3529f3d613f4 64980-406 HUMAN PRESCRIPTION DRUG Efavirenz Efavirenz CAPSULE ORAL 20171215 ANDA ANDA078064 Rising Pharmaceuticals, Inc. EFAVIRENZ 50 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 64980-407_a26cfa07-14a7-4468-8eed-3529f3d613f4 64980-407 HUMAN PRESCRIPTION DRUG Efavirenz Efavirenz CAPSULE ORAL 20171215 ANDA ANDA078064 Rising Pharmaceuticals, Inc. EFAVIRENZ 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 64980-409_de6daca8-2312-4959-9732-127914e7bc68 64980-409 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride SOLUTION, CONCENTRATE ORAL 20081031 ANDA ANDA078861 Rising Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 20 mg/mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 64980-426_91f3b2ba-e890-4073-976b-e6b131b2cfb3 64980-426 HUMAN PRESCRIPTION DRUG Tindazole Tinidazole TABLET, FILM COATED ORAL 20131009 ANDA ANDA202489 Rising Pharmaceuticals, Inc. TINIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 64980-427_91f3b2ba-e890-4073-976b-e6b131b2cfb3 64980-427 HUMAN PRESCRIPTION DRUG Tindazole Tinidazole TABLET, FILM COATED ORAL 20131009 ANDA ANDA202489 Rising Pharmaceuticals, Inc. TINIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 64980-431_f8ed80f2-6c3d-4d7f-b761-c2447973c1f9 64980-431 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET ORAL 20180201 ANDA ANDA209025 Rising Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 64980-437_6ea5b473-1543-446f-b8a8-1a4492e5ac87 64980-437 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100610 ANDA ANDA077443 Rising Pharmaceuticals, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 64980-438_6ea5b473-1543-446f-b8a8-1a4492e5ac87 64980-438 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100610 ANDA ANDA077443 Rising Pharmaceuticals, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 64980-439_6ea5b473-1543-446f-b8a8-1a4492e5ac87 64980-439 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100610 ANDA ANDA077443 Rising Pharmaceuticals, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 64980-503_9b4956a5-6449-4ddd-b04c-75ffff54e5e9 64980-503 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine SOLUTION ORAL 20040920 ANDA ANDA076851 Rising Pharmaceuticals, Inc. LEVOCARNITINE 1 g/10mL Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] N 20181231 64980-504_0e71ce54-21ff-4e4d-98a3-6085cffe2855 64980-504 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride SYRUP ORAL 20060710 ANDA ANDA040668 Rising Pharmaceuticals, Inc. CYPROHEPTADINE HYDROCHLORIDE 2 mg/5mL N 20181231 64980-509_a537286c-d8b2-4cc2-ac5e-a9b788a55989 64980-509 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone ELIXIR ORAL 20110801 ANDA ANDA090891 Rising Pharmaceuticals, Inc. DEXAMETHASONE .5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 64980-510_3f3d300d-a843-4da8-90d1-7a1a4c283c51 64980-510 HUMAN PRESCRIPTION DRUG Flunisolide Flunisolide SPRAY, METERED NASAL 20060803 ANDA ANDA077704 Rising Pharmaceuticals, Inc FLUNISOLIDE .25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 64980-511_fce073a8-bc9f-4e33-b078-33262e8a6a5f 64980-511 HUMAN PRESCRIPTION DRUG CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric) CLINDAMYCIN PALMITATE HYDROCHLORIDE GRANULE, FOR SOLUTION ORAL 20120911 ANDA ANDA201821 Rising Pharmaceuticals, Inc. CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 64980-513_860789c3-f543-4698-ad05-91d42b6f5f5e 64980-513 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 20141215 ANDA ANDA077259 Rising Pharmaceuticals, Inc. TIMOLOL MALEATE 2.5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 64980-514_860789c3-f543-4698-ad05-91d42b6f5f5e 64980-514 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 20141215 ANDA ANDA077259 Rising Pharmaceuticals, Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 64980-515_6757c17b-d1bc-4962-8324-13216f041c39 64980-515 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION OPHTHALMIC 20141215 ANDA ANDA078559 Rising Pharmaceuticals, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 64980-516_8822e6df-9765-4290-b1fe-e1a14782765d 64980-516 HUMAN PRESCRIPTION DRUG LATANOPROST latanoprost SOLUTION OPHTHALMIC 20160901 ANDA ANDA202442 Rising Pharmaceuticals, Inc. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 64980-517_a3f39a66-d9c4-483a-b786-87772d3f8a25 64980-517 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride Olopatadine Hydrochloride USP, 0.1% SOLUTION/ DROPS OPHTHALMIC 20151207 ANDA ANDA203152 Rising Pharmaceuticals, Inc. OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 64987-0266_61d18ca1-edbe-71cd-e053-2a91aa0a4550 64987-0266 HUMAN OTC DRUG Antibacterial Skin Rain Forest Extract From Entiere CHLOROXYLENOL SOAP TOPICAL 20170927 OTC MONOGRAPH NOT FINAL part333E World Club Supply Corp CHLOROXYLENOL .25 mg/100mL N 20191231 64987-0296_61d19d19-713f-0e8c-e053-2a91aa0a10b4 64987-0296 HUMAN OTC DRUG Antibacterial Skin Rain Forest Extract From Entiere TRICLOSAN SOAP TOPICAL 20140916 OTC MONOGRAPH NOT FINAL part333E World Club Supply Corp TRICLOSAN .2 mg/100mL N 20191231 64990-385_e6ff577b-325a-41d6-9c7d-326e992dd715 64990-385 HUMAN OTC DRUG DeoDry Antiperspirant Aluminum Chlorohydrate LOTION TOPICAL 20031028 OTC MONOGRAPH FINAL part350 Isomers laboratories Inc. ALUMINUM CHLOROHYDRATE 155 mg/mL N 20181231 64990-601_6c40c51f-59d2-4d7d-971f-a9d256bd7bcd 64990-601 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Gel Salicylic Acid GEL TOPICAL 20091226 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL E 20171231 64990-601_6cba7d97-428d-4655-a3cd-768a294d7ba5 64990-601 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Gel Salicylic Acid GEL TOPICAL 20091228 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL E 20171231 64990-601_913fb3f3-02cc-4d28-8651-5e5e6f954070 64990-601 HUMAN OTC DRUG Isomers Clear Skin Acne Spot Treatment Salicylic Acid GEL TOPICAL 20100301 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL E 20171231 64990-601_9532a7db-9aab-44ae-8e35-12d0e74b8f9b 64990-601 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Gel Salicylic Acid GEL TOPICAL 20091228 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL E 20171231 64990-605_157c8677-4395-4066-908e-861e5a7b317f 64990-605 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Lotion Salicylic Acid LOTION TOPICAL 20091228 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL E 20171231 64990-605_f0028189-5e3a-43b8-94d2-fd509b62343b 64990-605 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Lotion Salicylic Acid LOTION TOPICAL 20091226 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL E 20171231 64990-605_f2a273b5-ab49-4c45-8f5b-ef9a3cecc1ed 64990-605 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Lotion Salicylic Acid LOTION TOPICAL 20091226 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL E 20171231 64990-609_6de665eb-7991-4f17-b07e-ee443eacb9bf 64990-609 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Cleanser Salicylic Acid LIQUID TOPICAL 20100120 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL N 20181231 64990-609_8d064ebe-1ded-4c54-8076-196985d2d84d 64990-609 HUMAN OTC DRUG Isomers Clear Skin Acne Treatment Cleanser Salicylic Acid LIQUID TOPICAL 20100120 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc SALICYLIC ACID .02 mL/mL N 20181231 64990-609_b81af499-d7d1-4a74-bdbc-2f541d93dc76 64990-609 HUMAN OTC DRUG Clear Skin Acne Treatment Cleanser Salicylic Acid SOLUTION TOPICAL 20130425 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc. SALICYLIC ACID 20 mg/mL N 20181231 64990-610_b278c5cc-3b81-43ff-b30b-6cfca2f3b653 64990-610 HUMAN OTC DRUG Clear Skin Acne Treatment Salicylic Acid LOTION TOPICAL 20120427 OTC MONOGRAPH FINAL part333D Isomers Laboratories Inc. SALICYLIC ACID 20 mg/mL N 20181231 64990-885_1136b0ef-e786-4698-8359-71b789732d01 64990-885 HUMAN OTC DRUG Sunscreen with UV pearls Broad Spectrm SPF 20 Zinc Oxide, Octinoxate LOTION TOPICAL 20030331 OTC MONOGRAPH NOT FINAL part352 Isomers Laboratories Inc ZINC OXIDE; OCTINOXATE 80; 75 mg/mL; mg/mL N 20181231 64997-050_69b58ad6-892b-457a-bbb8-9f93e3fd62b4 64997-050 HUMAN OTC DRUG Kids Travel Sickness Cocculus 30C, Nux Vomica 30C, Borax 6C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES JATEORHIZA CALUMBA ROOT; STRYCHNOS NUX-VOMICA SEED; SODIUM BORATE 30; 30; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 64997-100_60671a69-e7ab-48d1-b701-179d405a2b85 64997-100 HUMAN OTC DRUG kids throat Aconite 30C, Belladonna 30C, Chamomilla 30C, Phytolacca 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES ACONITUM NAPELLUS; BELLADONNA LEAF; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 64997-150_43bac331-4a26-49fa-acd9-46512f784a1d 64997-150 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES DROSERA INTERMEDIA; SPONGIA OFFICINALIS WHOLE; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA VULGARIS; ATROPA BELLADONNA; IPECAC 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 64997-152_6533959c-0e9b-493c-8b69-c476b16c19be 64997-152 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES DROSERA INTERMEDIA; SPONGIA OFFICINALIS WHOLE; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA VULGARIS; ATROPA BELLADONNA; IPECAC 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 64997-180_2a0b9f7d-22bf-4948-9d4c-5427a673dcd1 64997-180 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES DROSERA INTERMEDIA; SPONGIA OFFICINALIS WHOLE; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA VULGARIS; ATROPA BELLADONNA; IPECAC 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 64997-200_26296285-c013-4145-9505-1d513cebe195 64997-200 HUMAN OTC DRUG kids cold Allium Cepa 30C, Kali Bichromium 30C, Kali Sulphuricum 30C, Nux Vomica 30C, Natrum Muriaticum 30C, Pulsatilla 30C, Silicea 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES ONION; POTASSIUM DICHROMATE; POTASSIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SODIUM CHLORIDE; PULSATILLA VULGARIS; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 64997-300_4df10b5e-4401-4b6f-905a-a8037c30eca7 64997-300 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipecacuhuana 30C, Pulsatilla 30C, Belladonna 30C KIT 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES E 20171231 64997-400_23a19922-eaa3-41f2-a2e7-4a62a33e7805 64997-400 HUMAN OTC DRUG kids cough cold and throat Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C KIT 20140430 UNAPPROVED HOMEOPATHIC KEYSUN PTY. LIMITED Also Traded as KEYSUN LABORATORIES E 20171231 65003-006_f9b9f621-52a1-4296-8d64-08ecc56810cf 65003-006 HUMAN OTC DRUG StarCap Medical Private Limited Isopropyl Alcohol SWAB TOPICAL 20140604 OTC MONOGRAPH FINAL part344 StarCap Medical Private Limited ISOPROPYL ALCOHOL 70 g/100g N 20181231 65003-007_5f6df9aa-249f-45be-b1af-3de034c3d959 65003-007 HUMAN OTC DRUG StarCap Medical Private Limited Isopropyl Alcohol SWAB TOPICAL 20140606 OTC MONOGRAPH FINAL part344 StarCap Medical Private Limited ISOPROPYL ALCOHOL 70 g/100g N 20181231 65003-008_0a260e6d-ee44-4813-9a3f-9659ffbc3713 65003-008 HUMAN OTC DRUG StarCap Medical Private Limited Isopropyl Alcohol SWAB TOPICAL 20140606 OTC MONOGRAPH FINAL part344 StarCap Medical Private Limited ISOPROPYL ALCOHOL 70 g/100g N 20181231 65003-018_59c8ee0d-dadd-4cf4-960f-f1f66cc282fd 65003-018 HUMAN OTC DRUG StarCap Medical Private Limited Isopropyl Alcohol SWAB TOPICAL 20140607 OTC MONOGRAPH FINAL part344 StarCap Medical Private Limited ISOPROPYL ALCOHOL 70 g/100g N 20181231 65008-003_0bf29124-b435-4b8b-9abf-5cf18c72c1ba 65008-003 HUMAN OTC DRUG Sunsorb SPF30 Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene LOTION TOPICAL 20041115 OTC MONOGRAPH FINAL part352 QS Key West Aloe, LLC OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 75; 50; 50; 20; 15 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 65008-004_2e390130-7d49-4362-bbee-82be24445e81 65008-004 HUMAN OTC DRUG Key West Tan SPF15 Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene LOTION TOPICAL 20040707 OTC MONOGRAPH FINAL part352 QS Key West Aloe, LLC OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 50; 30; 20; 20; 15 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 65008-005_5741d20b-37e0-4998-ac55-235d6dea2be9 65008-005 HUMAN OTC DRUG Comfortcaine Lidocaine HCL GEL TOPICAL 20041112 OTC MONOGRAPH NOT FINAL part348 QS Key West Aloe, LLC LIDOCAINE HYDROCHLORIDE 40 mg/g N 20181231 65010-001_4cc3d364-c76c-48ab-ad1b-31521085a6a3 65010-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19930101 NDA NDA206023 Technical Gas Products, Inc. OXYGEN 999 mL/L N 20181231 65028-001_1fc97cf8-e035-4857-880b-4f3309422805 65028-001 HUMAN OTC DRUG Full Care Povidone Iodine Swabsticks POVIDONE-IODINE SWAB TOPICAL 20140422 OTC MONOGRAPH FINAL part333C Shaoxing Fuqing Health Products Co., Ltd. POVIDONE-IODINE .2 g/1 E 20171231 65028-002_f59c60c9-393e-43ab-a47f-363a0ff45646 65028-002 HUMAN OTC DRUG Full Care BZK Towelette BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20140422 OTC MONOGRAPH NOT FINAL part333A Shaoxing Fuqing Health Products Co., Ltd. BENZALKONIUM CHLORIDE .0026 g/2mL E 20171231 65028-003_30f488ef-150d-4410-afba-389950675187 65028-003 HUMAN OTC DRUG Full Care Alcohol Swabsticks ISOPROPYL ALCOHOL SOLUTION TOPICAL 20140822 OTC MONOGRAPH NOT FINAL part333A Shaoxing Fuqing Health Products Co., Ltd. ISOPROPYL ALCOHOL 1.4 g/2mL E 20171231 65028-004_877c7550-3275-4796-893b-053383328122 65028-004 HUMAN OTC DRUG Full Care Alcohol Prep Pad ISOPROPYL ALCOHOL SOLUTION TOPICAL 20140822 OTC MONOGRAPH NOT FINAL part333A Shaoxing Fuqing Health Products Co., Ltd. ISOPROPYL ALCOHOL .14 g/.2mL E 20171231 65028-005_919a6cc7-2144-4e8e-87ff-3a3d6dead01d 65028-005 HUMAN OTC DRUG Full Care Three Povidone Iodine Swabsticks POVIDONE-IODINE SWAB TOPICAL 20140912 OTC MONOGRAPH FINAL part333C Shaoxing Fuqing Health Products Co., Ltd. POVIDONE-IODINE .2 g/1 E 20171231 65028-006_7ec39d5a-8573-476d-9f96-4a63be9b03f0 65028-006 HUMAN OTC DRUG Full Care Povidone Iodine Solution POVIDONE-IODINE SOLUTION TOPICAL 20140922 OTC MONOGRAPH FINAL part333C Shaoxing Fuqing Health Products Co., Ltd. POVIDONE-IODINE 1 g/100mL E 20171231 65028-007_7f9837d5-2686-4f22-8ac9-dd36d5288f39 65028-007 HUMAN OTC DRUG Full Care Povidone Iodine Prep Pad POVIDONE-IODINE SOLUTION TOPICAL 20141017 OTC MONOGRAPH FINAL part333C Shaoxing Fuqing Health Products Co., Ltd. POVIDONE-IODINE .01 g/mL E 20171231 65038-040_44a7e257-1fe2-42bb-e054-00144ff8d46c 65038-040 HUMAN PRESCRIPTION DRUG Clonidine CLONIDINE PATCH, EXTENDED RELEASE TRANSDERMAL 20160803 ANDA ANDA079090 Corium International, Inc. CLONIDINE .1 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 65038-041_44a7e257-1fe2-42bb-e054-00144ff8d46c 65038-041 HUMAN PRESCRIPTION DRUG Clonidine CLONIDINE PATCH, EXTENDED RELEASE TRANSDERMAL 20160803 ANDA ANDA079090 Corium International, Inc. CLONIDINE .2 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 65038-042_44a7e257-1fe2-42bb-e054-00144ff8d46c 65038-042 HUMAN PRESCRIPTION DRUG Clonidine CLONIDINE PATCH, EXTENDED RELEASE TRANSDERMAL 20160803 ANDA ANDA079090 Corium International, Inc. CLONIDINE .3 mg/24h Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 65044-0537_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0537 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Bermuda Grass Standardized Grass Pollen, Bermuda Grass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103872 Jubilant HollisterStier LLC CYNODON DACTYLON POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0538_d754b229-32d2-411d-a593-c666393b223b 65044-0538 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Bermuda Grass Standardized Grass Pollen, Bermuda Grass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103872 Jubilant HollisterStier LLC CYNODON DACTYLON POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0545_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0545 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Bluegrass, Kentucky June Standardized Grass Pollen, Bluegrass, Kentucky June INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0546_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0546 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Bluegrass, Kentucky June Standardized Grass Pollen, Bluegrass, Kentucky June INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0547_d754b229-32d2-411d-a593-c666393b223b 65044-0547 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Bluegrass, Kentucky June Standardized Grass Pollen, Bluegrass, Kentucky June INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0548_d754b229-32d2-411d-a593-c666393b223b 65044-0548 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Bluegrass, Kentucky June Standardized Grass Pollen, Bluegrass, Kentucky June INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0611_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0611 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Fescue, Meadow Standardized Grass Pollen, Fescue, Meadow INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103874 Jubilant HollisterStier LLC FESTUCA PRATENSIS POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0612_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0612 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Fescue, Meadow Standardized Grass Pollen, Fescue, Meadow INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103874 Jubilant HollisterStier LLC FESTUCA PRATENSIS POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0613_d754b229-32d2-411d-a593-c666393b223b 65044-0613 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Fescue, Meadow Standardized Grass Pollen, Fescue, Meadow INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103874 Jubilant HollisterStier LLC FESTUCA PRATENSIS POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0614_d754b229-32d2-411d-a593-c666393b223b 65044-0614 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Fescue, Meadow Standardized Grass Pollen, Fescue, Meadow INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103874 Jubilant HollisterStier LLC FESTUCA PRATENSIS POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0718_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0718 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Orchard Grass Standardized Grass Pollen, Orchard Grass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103875 Jubilant HollisterStier LLC DACTYLIS GLOMERATA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0719_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0719 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Orchard Grass Standardized Grass Pollen, Orchard Grass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103875 Jubilant HollisterStier LLC DACTYLIS GLOMERATA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0720_d754b229-32d2-411d-a593-c666393b223b 65044-0720 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Orchard Grass Standardized Grass Pollen, Orchard Grass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103875 Jubilant HollisterStier LLC DACTYLIS GLOMERATA POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0721_d754b229-32d2-411d-a593-c666393b223b 65044-0721 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Orchard Grass Standardized Grass Pollen, Orchard Grass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103875 Jubilant HollisterStier LLC DACTYLIS GLOMERATA POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0777_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0777 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Redtop Standardized Grass Pollen, Redtop INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103876 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0778_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0778 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Redtop Standardized Grass Pollen, Redtop INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103876 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0779_d754b229-32d2-411d-a593-c666393b223b 65044-0779 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Redtop Standardized Grass Pollen, Redtop INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103876 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0780_d754b229-32d2-411d-a593-c666393b223b 65044-0780 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Redtop Standardized Grass Pollen, Redtop INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103876 Jubilant HollisterStier LLC AGROSTIS GIGANTEA POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0787_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0787 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Ryegrass Standardized Grass Pollen, Ryegrass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103877 Jubilant HollisterStier LLC LOLIUM PERENNE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0788_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0788 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Ryegrass Standardized Grass Pollen, Ryegrass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103877 Jubilant HollisterStier LLC LOLIUM PERENNE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0789_d754b229-32d2-411d-a593-c666393b223b 65044-0789 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Ryegrass Standardized Grass Pollen, Ryegrass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103877 Jubilant HollisterStier LLC LOLIUM PERENNE POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0790_d754b229-32d2-411d-a593-c666393b223b 65044-0790 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Ryegrass Standardized Grass Pollen, Ryegrass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103877 Jubilant HollisterStier LLC LOLIUM PERENNE POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0825_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0825 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Sweet Vernal Grass Standardized Grass Pollen, Sweet Vernal Grass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103878 Jubilant HollisterStier LLC ANTHOXANTHUM ODORATUM POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0826_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0826 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Sweet Vernal Grass Standardized Grass Pollen, Sweet Vernal Grass INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103878 Jubilant HollisterStier LLC ANTHOXANTHUM ODORATUM POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0827_d754b229-32d2-411d-a593-c666393b223b 65044-0827 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Sweet Vernal Grass Standardized Grass Pollen, Sweet Vernal Grass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103878 Jubilant HollisterStier LLC ANTHOXANTHUM ODORATUM POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0828_d754b229-32d2-411d-a593-c666393b223b 65044-0828 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Sweet Vernal Grass Standardized Grass Pollen, Sweet Vernal Grass INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103878 Jubilant HollisterStier LLC ANTHOXANTHUM ODORATUM POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0831_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0831 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Timothy Standardized Grass Pollen, Timothy INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103879 Jubilant HollisterStier LLC PHLEUM PRATENSE POLLEN 10000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0832_762e1ad3-9eb8-43e9-9a5c-dbcde5310166 65044-0832 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Timothy Standardized Grass Pollen, Timothy INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103879 Jubilant HollisterStier LLC PHLEUM PRATENSE POLLEN 100000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0833_d754b229-32d2-411d-a593-c666393b223b 65044-0833 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Timothy Standardized Grass Pollen, Timothy INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103879 Jubilant HollisterStier LLC PHLEUM PRATENSE POLLEN 100 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0834_d754b229-32d2-411d-a593-c666393b223b 65044-0834 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Timothy Standardized Grass Pollen, Timothy INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103879 Jubilant HollisterStier LLC PHLEUM PRATENSE POLLEN 1000 [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0841_5ca2f3cc-2dab-412a-b8ef-859fdbc85fad 65044-0841 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Grass Mix 4 Standardized Grass Pollen, Grass Mix 4 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN 2500; 2500; 2500; 2500 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0842_5ca2f3cc-2dab-412a-b8ef-859fdbc85fad 65044-0842 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Grass Mix 4 Standardized Grass Pollen, Grass Mix 4 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN 25000; 25000; 25000; 25000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0843_5ca2f3cc-2dab-412a-b8ef-859fdbc85fad 65044-0843 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Grass Mix 4 Standardized Grass Pollen, Grass Mix 4 INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN 25; 25; 25; 25 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0844_5ca2f3cc-2dab-412a-b8ef-859fdbc85fad 65044-0844 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Grass Mix 4 Standardized Grass Pollen, Grass Mix 4 INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN 250; 250; 250; 250 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0845_5ca2f3cc-2dab-412a-b8ef-859fdbc85fad 65044-0845 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Grass Mix 5 Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN 2000; 2000; 2000; 2000; 2000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0846_5ca2f3cc-2dab-412a-b8ef-859fdbc85fad 65044-0846 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Grass Mix 5 Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980105 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN 20000; 20000; 20000; 20000; 20000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0847_5ca2f3cc-2dab-412a-b8ef-859fdbc85fad 65044-0847 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Grass Mix 5 Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN 20; 20; 20; 20; 20 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0848_5ca2f3cc-2dab-412a-b8ef-859fdbc85fad 65044-0848 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Grass Mix 5 Standardized Grass Pollen, Grass Mix 5 INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN 200; 200; 200; 200; 200 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0850_5ca2f3cc-2dab-412a-b8ef-859fdbc85fad 65044-0850 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Grass Mix 7 Standardized Grass Pollen, Grass Mix 7 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN 1428; 1428; 1428; 1428; 1428; 1428; 1428 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0851_5ca2f3cc-2dab-412a-b8ef-859fdbc85fad 65044-0851 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Grass Mix 7 Standardized Grass Pollen, Grass Mix 7 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19980105 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN 14285; 14285; 14285; 14285; 14285; 14285; 14285 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0852_5ca2f3cc-2dab-412a-b8ef-859fdbc85fad 65044-0852 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Grass Mix 7 Standardized Grass Pollen, Grass Mix 7 INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN 14; 14; 14; 14; 14; 14; 14 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0853_5ca2f3cc-2dab-412a-b8ef-859fdbc85fad 65044-0853 STANDARDIZED ALLERGENIC Standardized Grass Pollen, Grass Mix 7 Standardized Grass Pollen, Grass Mix 7 INJECTION, SOLUTION INTRADERMAL 19980115 BLA BLA103873 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN 142; 142; 142; 142; 142; 142; 142 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0854_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-0854 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Southern Grass Mix Pollens - Grasses, Southern Grass Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; SORGHUM HALEPENSE POLLEN; CYNODON DACTYLON POLLEN 100000; 100000; 100000; 100000; 100000; .05; 10000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0855_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-0855 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Southern Grass Mix Pollens - Grasses, Southern Grass Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; SORGHUM HALEPENSE POLLEN; CYNODON DACTYLON POLLEN 100000; 100000; 100000; 100000; 100000; .05; 10000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0856_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-0856 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Southern Grass Mix Pollens - Grasses, Southern Grass Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; SORGHUM HALEPENSE POLLEN; CYNODON DACTYLON POLLEN 10000; 10000; 10000; 10000; 10000; .005; 1000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0857_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-0857 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Southern Grass Mix Pollens - Grasses, Southern Grass Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN; SORGHUM HALEPENSE POLLEN; CYNODON DACTYLON POLLEN 10000; 10000; 10000; 10000; 10000; .005; 1000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-0879_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-0879 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Grass Mix 8 Grass Mix 8 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POA PRATENSIS POLLEN; CYNODON DACTYLON POLLEN; SORGHUM HALEPENSE POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN 100000; 10000; .05; 100000; 100000 [BAU]/mL; [BAU]/mL; g/mL; [BAU]/mL; [BAU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1006_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-1006 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Acacia Acacia longifolia Acacia longifolia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACACIA LONGIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1007_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-1007 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Acacia Acacia longifolia Acacia longifolia INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACACIA LONGIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1008_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1008 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Acacia Acacia longifolia Acacia longifolia INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACACIA LONGIFOLIA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1018_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-1018 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Alder, Red Alnus rubra Alder, Red Alnus rubra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALNUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1019_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-1019 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Alder, Red Alnus rubra Alder, Red Alnus rubra INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALNUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1020_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1020 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Alder, Red Alnus rubra Alder, Red Alnus rubra INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALNUS RUBRA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1021_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-1021 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Alder, Red Alnus rubra Alder, Red Alnus rubra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALNUS RUBRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1060_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-1060 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Ash, White Fraxinus americana Ash, White Fraxinus americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1061_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-1061 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Ash, White Fraxinus americana Ash, White Fraxinus americana INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1062_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1062 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Ash, White Fraxinus americana Ash, White Fraxinus americana INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1081_e4502b15-1610-4791-9d15-05e91bcd6579 65044-1081 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Bahia Grass Paspalum notatum Bahia Grass Paspalum notatum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1082_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-1082 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Bahia Grass Paspalum notatum Bahia Grass Paspalum notatum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PASPALUM NOTATUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1083_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1083 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Bahia Grass Paspalum notatum Bahia Grass Paspalum notatum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PASPALUM NOTATUM POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1084_e4502b15-1610-4791-9d15-05e91bcd6579 65044-1084 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Bahia Grass Paspalum notatum Bahia Grass Paspalum notatum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PASPALUM NOTATUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1120_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-1120 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Beech, American Fagus grandifolia Beech, American Fagus grandifolia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1121_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-1121 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Beech, American Fagus grandifolia Beech, American Fagus grandifolia INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FAGUS GRANDIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1168_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-1168 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Birch Mix Birch Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN; BETULA NIGRA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1169_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-1169 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Birch Mix Birch Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN; BETULA NIGRA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1170_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1170 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Birch Mix Birch Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN; BETULA NIGRA POLLEN 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1171_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-1171 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Birch Mix Birch Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN; BETULA NIGRA POLLEN .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1172_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-1172 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Birch Mix Birch Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN; BETULA NIGRA POLLEN 20000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1207_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-1207 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Bottle Brush Callistemon spp. Bottle Brush Callistemon spp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MELALEUCA CITRINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1208_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-1208 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Bottlebrush, Callistemon spp. Bottlebrush, Callistemon citrinus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MELALEUCA CITRINA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1213_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-1213 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Boxelder/Maple Mix Boxelder/Maple Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1214_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-1214 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Boxelder/Maple Mix Boxelder/Maple Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1215_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1215 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Boxelder/Maple Mix Boxelder/Maple Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1216_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1216 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Boxelder/Maple Mix Boxelder/Maple Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1217_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1217 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Boxelder/Maple Mix Boxelder/Maple Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN; ACER RUBRUM POLLEN 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1237_e4502b15-1610-4791-9d15-05e91bcd6579 65044-1237 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Brome, Smooth Bromus inermis Brome, Smooth Bromus inermis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1238_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-1238 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Brome, Smooth Bromus inermis Brome, Smooth Bromus inermis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BROMUS INERMIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1297_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-1297 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Careless Weed Amaranthus palmeri Careless Weed Amaranthus palmeri INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1298_9cd0229d-839f-4cfe-8261-98da82cb538c 65044-1298 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Careless Weed Amaranthus palmeri Careless Weed Amaranthus palmeri INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS PALMERI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1300_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-1300 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Careless/Pigweed Mix Careless/Pigweed Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1301_9cd0229d-839f-4cfe-8261-98da82cb538c 65044-1301 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Careless/Pigweed Mix Careless/Pigweed Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1302_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1302 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Careless/Pigweed Mix Careless/Pigweed Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN 500; 500 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1303_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-1303 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Careless/Pigweed Mix Careless/Pigweed Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN .1; .1 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1336_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1336 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Mountain Juniperus ashei Cedar, Mountain Juniperus ashei INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1337_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-1337 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Mountain Juniperus ashei Cedar, Mountain Juniperus ashei INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS ASHEI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1338_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1338 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Mountain Juniperus ashei Cedar, Mountain Juniperus ashei INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS ASHEI POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1339_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1339 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Mountain Juniperus ashei Cedar, Mountain Juniperus ashei INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS ASHEI POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1340_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-1340 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Red Juniperus virginiana Cedar, Red Juniperus virginiana INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1341_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1341 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Red Juniperus virginiana Cedar, Red Juniperus virginiana INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS VIRGINIANA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1342_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1342 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Red Juniperus virginiana Cedar, Red Juniperus virginiana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS VIRGINIANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1343_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1343 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cedar, Red Juniperus virginiana Cedar, Red Juniperus virginiana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUNIPERUS VIRGINIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1405_f565c537-c530-4986-8902-de677259a766 65044-1405 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Cocklebur Xanthium strumarium Cocklebur Xanthium strumarium INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1406_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-1406 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Cocklebur Xanthium strumarium Cocklebur Xanthium strumarium INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1407_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1407 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Cocklebur Xanthium strumarium Cocklebur Xanthium strumarium INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1408_f565c537-c530-4986-8902-de677259a766 65044-1408 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Cocklebur Xanthium strumarium Cocklebur Xanthium strumarium INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1409_f565c537-c530-4986-8902-de677259a766 65044-1409 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Cocklebur Xanthium strumarium Cocklebur Xanthium strumarium INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1414_e4502b15-1610-4791-9d15-05e91bcd6579 65044-1414 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Corn, Cultivated Zea mays Corn, Cultivated Zea mays INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1415_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-1415 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Corn, Cultivated Zea mays Corn, Cultivated Zea mays INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ZEA MAYS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1435_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1435 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cottonwood, Common Populus deltoides Cottonwood, Common Populus deltoides INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1436_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1436 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cottonwood, Common Populus deltoides Cottonwood, Common Populus deltoides INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POPULUS DELTOIDES POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1437_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1437 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cottonwood, Common Populus deltoides Cottonwood, Common Populus deltoides INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC POPULUS DELTOIDES POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1438_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1438 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cottonwood, Common Populus deltoides Cottonwood, Common Populus deltoides INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POPULUS DELTOIDES POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1450_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1450 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cypress, Arizona Cupressus arizonica Cypress, Arizona Cupressus arizonica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1451_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1451 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cypress, Arizona Cupressus arizonica Cypress, Arizona Cupressus arizonica INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CUPRESSUS ARIZONICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1453_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1453 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cypress, Bald Taxodium distichum Cypress, Bald Taxodium distichum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TAXODIUM DISTICHUM POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1454_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1454 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Cypress, Bald Taxodium distichum Cypress, Bald Taxodium distichum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TAXODIUM DISTICHUM POLLEN .02 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1516_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-1516 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Dock/Sorrel Mix Pollens - Weeds, Dock/Sorrel Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-1517_9cd0229d-839f-4cfe-8261-98da82cb538c 65044-1517 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Dock/Sorrel Mix Pollens - Weeds, Dock/Sorrel Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-1518_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1518 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Dock/Sorrel Mix Pollens - Weeds, Dock/Sorrel Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN 500; 500 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-1519_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-1519 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Dock/Sorrel Mix Pollens - Weeds, Dock/Sorrel Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN .1; .1 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-1520_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-1520 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Dock/Sorrel Mix Pollens - Weeds, Dock/Sorrel Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN 20000; 20000 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-1540_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1540 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, American Ulmus americana Elm, American Ulmus americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1541_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1541 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, American Ulmus americana Elm, American Ulmus americana INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1542_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1542 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, American Ulmus americana Elm, American Ulmus americana INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS AMERICANA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1543_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1543 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, American Ulmus americana Elm, American Ulmus americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS AMERICANA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1544_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1544 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, American Ulmus americana Elm, American Ulmus americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS AMERICANA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1546_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1546 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, Chinese Ulmus parvifolia Elm, Chinese Ulmus parvifolia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS PARVIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1547_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1547 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, Chinese Ulmus parvifolia Elm, Chinese Ulmus parvifolia INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS PARVIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1548_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1548 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Elm, Chinese Ulmus parvifolia Elm, Chinese Ulmus parvifolia INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ULMUS PARVIFOLIA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1564_b9ad1215-9f64-443f-82cc-eef93599a709 65044-1564 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Eucalyptus, Eucalyptus globulus Eucalyptus, Eucalyptus globulus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1565_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1565 NON-STANDARDIZED ALLERGENIC POLLENS - TREES, EUCALYPTUS, EUCALYPTUS GLOBULUS Eucalyptus globulus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EUCALYPTUS GLOBULUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1630_f565c537-c530-4986-8902-de677259a766 65044-1630 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Goldenrod Solidago canadensis Goldenrod Solidago canadensis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1631_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-1631 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Goldenrod Solidago canadensis Goldenrod Solidago canadensis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLIDAGO CANADENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1632_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1632 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Goldenrod Solidago canadensis Goldenrod Solidago canadensis INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLIDAGO CANADENSIS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1660_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-1660 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Gum, Sweet Liquidambar styraciflua Gum, Sweet Liquidambar styraciflua INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1661_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1661 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Gum, Sweet Liquidambar styraciflua Gum, Sweet Liquidambar styraciflua INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LIQUIDAMBAR STYRACIFLUA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1662_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-1662 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Gum, Sweet Liquidambar styraciflua Gum, Sweet Liquidambar styraciflua INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LIQUIDAMBAR STYRACIFLUA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1663_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-1663 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Hackberry Celtis occidentalis Hackberry Celtis occidentalis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1664_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1664 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Hackberry Celtis occidentalis Hackberry Celtis occidentalis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CELTIS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1665_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1665 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Hackberry Celtis occidentalis Hackberry Celtis occidentalis INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CELTIS OCCIDENTALIS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1702_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-1702 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Hickory, Shagbark Carya ovata Hickory, Shagbark Carya ovata INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1703_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1703 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Hickory, Shagbark Carya ovata Hickory, Shagbark Carya ovata INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA OVATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1744_e4502b15-1610-4791-9d15-05e91bcd6579 65044-1744 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Johnson Grass Sorghum halepense Johnson Grass Sorghum halepense INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1745_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-1745 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Johnson Grass Sorghum halepense Johnson Grass Sorghum halepense INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SORGHUM HALEPENSE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1746_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1746 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Johnson Grass Sorghum halepense Johnson Grass Sorghum halepense INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC SORGHUM HALEPENSE POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1747_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-1747 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Johnson Grass Sorghum halepense Johnson Grass Sorghum halepense INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SORGHUM HALEPENSE POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1780_2aa1cc43-833a-4737-8682-4205fb01fdb3 65044-1780 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Kochia scoparia Kochia scoparia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BASSIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1781_9cd0229d-839f-4cfe-8261-98da82cb538c 65044-1781 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Kochia scoparia Kochia scoparia INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BASSIA SCOPARIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1782_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1782 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Kochia scoparia Kochia scoparia INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC BASSIA SCOPARIA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1783_2aa1cc43-833a-4737-8682-4205fb01fdb3 65044-1783 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Kochia scoparia Kochia scoparia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BASSIA SCOPARIA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1786_f565c537-c530-4986-8902-de677259a766 65044-1786 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Lambs Quarters Chenopodium album Lambs Quarters Chenopodium album INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1787_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-1787 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Lamb Quarters Chenopodium album Lamb Quarters Chenopodium album INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CHENOPODIUM ALBUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1788_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1788 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Lamb Quarters Chenopodium album Lamb Quarters Chenopodium album INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CHENOPODIUM ALBUM POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1789_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-1789 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Lambs Quarters Chenopodium album Lambs Quarters Chenopodium album INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CHENOPODIUM ALBUM POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1790_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-1790 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Lambs Quarters Chenopodium album Lambs Quarters Chenopodium album INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CHENOPODIUM ALBUM POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1791_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-1791 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Lambs Quarters Chenopodium album Lambs Quarters Chenopodium album INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CHENOPODIUM ALBUM POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1801_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-1801 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Linden Basswood Tilia americana Linden Basswood Tilia americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TILIA AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1802_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1802 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Linden Basswood Tilia americana Linden Basswood Tilia americana INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TILIA AMERICANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1831_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-1831 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Maple, Hard Acer saccharum Maple, Hard Acer saccharum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1832_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1832 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Maple, Hard Acer saccharum Maple, Hard Acer saccharum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER SACCHARUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1833_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1833 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Maple, Hard Acer saccharum Maple, Hard Acer saccharum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ACER SACCHARUM POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1858_2aa1cc43-833a-4737-8682-4205fb01fdb3 65044-1858 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Marshelder/Poverty Mix Pollens - Weeds, Marshelder/Poverty Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC IVA AXILLARIS POLLEN; IVA ANNUA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1859_9cd0229d-839f-4cfe-8261-98da82cb538c 65044-1859 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Marshelder/Poverty Mix Pollens - Weeds, Marshelder/Poverty Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC IVA AXILLARIS POLLEN; IVA ANNUA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1860_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1860 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Marshelder/Poverty Mix Pollens - Weeds, Marshelder/Poverty Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC IVA AXILLARIS POLLEN; IVA ANNUA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1861_2aa1cc43-833a-4737-8682-4205fb01fdb3 65044-1861 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Marshelder/Poverty Mix Pollens - Weeds, Marshelder/Poverty Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC IVA AXILLARIS POLLEN; IVA ANNUA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1873_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-1873 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Melaleuca Punk Tree Melaleuca quinquenervia Melaleuca Punk Tree Melaleuca quinquenervia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1874_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1874 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Melaleuca Punk Tree Melaleuca quinquenervia Melaleuca, Melaleuca quinquenervia INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MELALEUCA QUINQUENERVIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1876_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-1876 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mesquite, Prosopis juliflora Mesquite, Prosopis juliflora INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1877_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1877 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mesquite, Prosopis juliflora Mesquite, Prosopis juliflora INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PROSOPIS JULIFLORA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1878_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1878 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mesquite, Prosopis juliflora Mesquite, Prosopis juliflora INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PROSOPIS JULIFLORA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1909_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-1909 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mulberry Mix Mulberry Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MORUS ALBA POLLEN; MORUS RUBRA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1910_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-1910 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mulberry Mix Mulberry Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MORUS ALBA POLLEN; MORUS RUBRA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1911_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-1911 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mulberry Mix Mulberry Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC MORUS ALBA POLLEN; MORUS RUBRA POLLEN 500; 500 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1912_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-1912 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Mulberry Mix Mulberry Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MORUS ALBA POLLEN; MORUS RUBRA POLLEN .1; .1 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1945_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-1945 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Nettle Urtica dioica Nettle Urtica dioica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC URTICA DIOICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1946_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-1946 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Nettle Urtica dioica Nettle Urtica dioica INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC URTICA DIOICA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-1947_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-1947 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Nettle Urtica dioica Nettle Urtica dioica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC URTICA DIOICA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2014_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-2014 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak, Red Quercus rubra Oak, Red Quercus rubra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2015_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2015 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak, Red Quercus rubra Oak, Red Quercus rubra INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS RUBRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2016_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2016 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak, Red Quercus rubra Oak, Red Quercus rubra INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS RUBRA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2017_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2017 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Palo Verde Cercidium floridum Palo Verde Cercidium floridum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PARKINSONIA FLORIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2018_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2018 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Palo Verde Cercidium floridum Palo Verde Cercidium floridum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PARKINSONIA FLORIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2035_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-2035 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak Mix Oak Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2036_45e7464b-886e-4236-b3cf-aa83a29c5052 65044-2036 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak Mix Oak Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2037_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2037 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak Mix Oak Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2038_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-2038 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak Mix Oak Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2039_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-2039 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Oak Mix Oak Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2041_d6a5e15d-d2de-4d88-9f10-9c00b9fa4f16 65044-2041 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Oats, Common, Cultivated Avena sativa Oats, Common, Cultivated Avena sativa INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AVENA SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2042_cd06c2cc-8182-4079-93ad-e3361ec7c7f3 65044-2042 NON-STANDARDIZED ALLERGENIC Pollens - Grasses, Oats, Common, Cultivated Avena sativa Oats, Common, Cultivated Avena sativa INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AVENA SATIVA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2050_cc21419d-b7fd-4e1b-8940-7067fe97d3ad 65044-2050 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Olive Olea europaea Olive Olea europaea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2051_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2051 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Olive Olea europaea Olive Olea europaea INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC OLEA EUROPAEA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2052_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2052 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Olive Olea europaea Olive Olea europaea INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC OLEA EUROPAEA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2053_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2053 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Olive Olea europaea Olive Olea europaea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC OLEA EUROPAEA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2057_f565c537-c530-4986-8902-de677259a766 65044-2057 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Dog Fennel, Eastern Eupatorium capillifolium Dog Fennel, Eastern Eupatorium capillifolium INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2058_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-2058 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Dog Fennel Eupatorium capillifolium Dog Fennel Eupatorium capillifolium INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EUPATORIUM CAPILLIFOLIUM POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2074_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2074 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Palm, Queen Cocos plumosa Palm, Queen Cocos plumosa INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2075_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2075 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Palm, Queen Cocos plumosa Palm, Queen Cocos plumosa INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SYAGRUS ROMANZOFFIANA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2098_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2098 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pecan Carya Carya illinoensis Pecan Carya Carya illinoensis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2099_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2099 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pecan Carya Carya illinoensis Pecan Carya Carya illinoensis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2100_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2100 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pecan Carya Carya illinoensis Pecan Carya Carya illinoensis INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2101_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2101 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pecan Carya Carya illinoensis Pecan Carya Carya illinoensis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2107_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2107 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pepper Tree, California Schinus molle Pepper Tree, California Schinus molle INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2108_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2108 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pepper Tree, California Schinus molle Pepper Tree, California Schinus molle INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SCHINUS MOLLE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2125_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-2125 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Pigweed, Rough Redroot Amaranthus retroflexus Pigweed, Rough Redroot Amaranthus retroflexus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2126_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-2126 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Pigweed, Rough Redroot Amaranthus retroflexus Pigweed, Rough Redroot Amaranthus retroflexus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS RETROFLEXUS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2127_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2127 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Pigweed, Rough Redroot Amaranthus retroflexus Pigweed, Rough Redroot Amaranthus retroflexus INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMARANTHUS RETROFLEXUS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2203_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2203 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pine Mix Pine Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PINUS CONTORTA POLLEN; PINUS PONDEROSA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2204_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2204 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Pine Mix Pine Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PINUS CONTORTA POLLEN; PINUS PONDEROSA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2212_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-2212 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2213_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-2213 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLANTAGO LANCEOLATA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2214_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2214 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLANTAGO LANCEOLATA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2215_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-2215 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLANTAGO LANCEOLATA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2216_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-2216 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLANTAGO LANCEOLATA POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2217_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-2217 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Plantain, English Plantago lanceolata Plantain, English Plantago lanceolata INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLANTAGO LANCEOLATA POLLEN 20000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2251_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2251 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Privet Ligustrum vulgare Privet Ligustrum vulgare INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2252_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2252 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Privet Ligustrum vulgare Privet Ligustrum vulgare INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LIGUSTRUM VULGARE POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2293_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-2293 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed, Giant Ambrosia trifida Ragweed, Giant Ambrosia trifida INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2294_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-2294 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed, Giant Ambrosia trifida Ragweed, Giant Ambrosia trifida INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2295_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2295 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed, Giant Ambrosia trifida Ragweed, Giant Ambrosia trifida INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2296_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-2296 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed, Giant Ambrosia trifida Ragweed, Giant Ambrosia trifida INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2297_73e95213-c134-45f5-adfd-318305c81f7b 65044-2297 STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Short Ragweed, Ambrosia artemisiifolia Short Ragweed, Ambrosia artemisiifolia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19771018 BLA BLA103880 Jubilant HollisterStier LLC AMBROSIA ARTEMISIIFOLIA POLLEN .05 g/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2298_73e95213-c134-45f5-adfd-318305c81f7b 65044-2298 STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Short Ragweed, Ambrosia artemisiifolia Short Ragweed, Ambrosia artemisiifolia INJECTION, SOLUTION INTRADERMAL 19771018 BLA BLA103880 Jubilant HollisterStier LLC AMBROSIA ARTEMISIIFOLIA POLLEN 500 [PNU]/mL Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2308_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-2308 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed. Western Ambrosia psilostachya Ragweed. Western Ambrosia psilostachya INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2309_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-2309 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed. Western Ambrosia psilostachya Ragweed. Western Ambrosia psilostachya INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA PSILOSTACHYA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2310_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2310 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed. Western Ambrosia psilostachya Ragweed. Western Ambrosia psilostachya INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA PSILOSTACHYA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2311_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-2311 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed. Western Ambrosia psilostachya Ragweed. Western Ambrosia psilostachya INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA PSILOSTACHYA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2315_73e95213-c134-45f5-adfd-318305c81f7b 65044-2315 STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia Ragweed, Mixed Ambrosia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN .05; .05 g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2316_73e95213-c134-45f5-adfd-318305c81f7b 65044-2316 STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia Ragweed, Mixed Ambrosia INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN 500; 500 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2317_73e95213-c134-45f5-adfd-318305c81f7b 65044-2317 STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia Ragweed, Mixed Ambrosia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN 20000; 20000 [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2318_9cd0229d-839f-4cfe-8261-98da82cb538c 65044-2318 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Giant, Short, Western Ragweed Mix Giant, Short, Western Ragweed Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2319_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2319 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Giant, Short, Western Ragweed Mix Giant, Short, Western Ragweed Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2320_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-2320 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Giant, Short, Western Ragweed Mix Giant, Short, Western Ragweed Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN .05; .05; .05 g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2359_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2359 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Russian Olive Elaeagnus angustifolia Russian Olive Elaeagnus angustifolia INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ELAEAGNUS ANGUSTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2360_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2360 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Olive, Russian Elaeagnus angustifolia Russian Olive Elaeagnus angustifolia INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ELAEAGNUS ANGUSTIFOLIA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2361_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2361 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Russian Olive Elaeagnus angustifolia Russian Olive Elaeagnus angustifolia INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ELAEAGNUS ANGUSTIFOLIA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2362_61366d6e-fcde-4ece-949a-9b4b269e2c5f 65044-2362 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Russian Thistle Salsola kali Russian Thistle Salsola kali INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2363_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-2363 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Russian Thistle Salsola kali Russian Thistle Salsola kali INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALSOLA KALI POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2364_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2364 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Russian Thistle Salsola kali Russian Thistle Salsola kali INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALSOLA KALI POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2413_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-2413 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sagebrush, Mugwort Artemisia vulgaris Sagebrush, Mugwort Artemisia vulgaris INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2414_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-2414 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sagebrush, Mugwort Artemisia vulgaris Sagebrush, Mugwort Artemisia vulgaris INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ARTEMISIA VULGARIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2415_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2415 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sagebrush, Mugwort Artemisia vulgaris Sagebrush, Mugwort Artemisia vulgaris INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ARTEMISIA VULGARIS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2416_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-2416 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sagebrush, Mugwort Artemisia vulgaris Sagebrush, Mugwort Artemisia vulgaris INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ARTEMISIA VULGARIS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2417_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-2417 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sagebrush, Mugwort Artemisia vulgaris Sagebrush, Mugwort Artemisia vulgaris INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ARTEMISIA VULGARIS POLLEN 40000 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2482_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-2482 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Scale, Wing Shad Atriplex canescens Scale, Wing Shad Atriplex canescens INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ATRIPLEX CANESCENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2483_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-2483 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Scale, Wing Shad Atriplex canescens Scale, Wing Shad Atriplex canescens INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ATRIPLEX CANESCENS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2484_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2484 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Scale, Wing Shad Atriplex canescens Scale, Wing Shad Atriplex canescens INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ATRIPLEX CANESCENS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2485_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-2485 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Scale, Wing Shad Atriplex canescens Scale, Wing Shad Atriplex canescens INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ATRIPLEX CANESCENS POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2486_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-2486 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Scotch Broom Cytisus scoparius Scotch Broom Cytisus scoparius INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CYTISUS SCOPARIUS FLOWERING TOP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2487_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-2487 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Scotch Broom Cytisus scoparius Scotch Broom Cytisus scoparius INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CYTISUS SCOPARIUS FLOWERING TOP .05 g/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2506_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-2506 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sorrel, Sheep Rumex acetosella Sorrel, Sheep Rumex acetosella INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-2507_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-2507 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sorrel, Sheep Rumex acetosella Sorrel, Sheep Rumex acetosella INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX ACETOSELLA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-2508_84cf2b22-3ceb-4e59-8f5d-2e33646ea6e7 65044-2508 NON-STANDARDIZED ALLERGENIC Pollens - Weeds and Garden Plants, Sorrel, Sheep Rumex acetosella Sorrel, Sheep Rumex acetosella INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RUMEX ACETOSELLA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-2563_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2563 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Sycamore, American Eastern Platanus occidentallis Sycamore, American Eastern Platanus occidentallis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2564_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2564 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Sycamore, American Eastern Platanus occidentallis Sycamore, American Eastern Platanus occidentallis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLATANUS OCCIDENTALIS POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2565_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2565 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Sycamore, American Eastern Platanus occidentallis Sycamore, American Eastern Platanus occidentallis INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLATANUS OCCIDENTALIS POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2599_f565c537-c530-4986-8902-de677259a766 65044-2599 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree of Heaven Ailanthus altissima Tree of Heaven Ailanthus altissima INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2600_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2600 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree of Heaven Ailanthus altissima Tree of Heaven Ailanthus altissima INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AILANTHUS ALTISSIMA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2619_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2619 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA NIGRA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; CARYA OVATA POLLEN; ACER SACCHARUM POLLEN; QUERCUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN .05; .05; .05; .05; .05; .05; .05; .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2620_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2620 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA NIGRA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; CARYA OVATA POLLEN; ACER SACCHARUM POLLEN; QUERCUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN .05; .05; .05; .05; .05; .05; .05; .05; .05; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2621_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2621 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA NIGRA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; CARYA OVATA POLLEN; ACER SACCHARUM POLLEN; QUERCUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN 500; 500; 500; 500; 500; 500; 500; 500; 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2622_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2622 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA NIGRA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; CARYA OVATA POLLEN; ACER SACCHARUM POLLEN; QUERCUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN .1; .1; .1; .1; .1; .1; .1; .1; .1; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2623_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2623 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA NIGRA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; CARYA OVATA POLLEN; ACER SACCHARUM POLLEN; QUERCUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN 40000; 40000; 40000; 40000; 40000; 40000; 40000; 40000; 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2624_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2624 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 11 Tree Mix 11 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA NIGRA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN; CARYA OVATA POLLEN; ACER SACCHARUM POLLEN; QUERCUS RUBRA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2626_f565c537-c530-4986-8902-de677259a766 65044-2626 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2627_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2627 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUGLANS NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2628_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2628 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUGLANS NIGRA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2629_f565c537-c530-4986-8902-de677259a766 65044-2629 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC JUGLANS NIGRA POLLEN .1 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2630_9cd0229d-839f-4cfe-8261-98da82cb538c 65044-2630 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN .05; .05; .05; .025; .025 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-2631_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2631 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN 500; 500; 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-2632_2aa1cc43-833a-4737-8682-4205fb01fdb3 65044-2632 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN .1; .1; .1; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-2633_2aa1cc43-833a-4737-8682-4205fb01fdb3 65044-2633 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN 40000; 40000; 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-2634_2aa1cc43-833a-4737-8682-4205fb01fdb3 65044-2634 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN .05; .05; .05; .025; .025 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-2635_2aa1cc43-833a-4737-8682-4205fb01fdb3 65044-2635 NON-STANDARDIZED ALLERGENIC Pollens - Weeds, Weed mix 2630 Weed mix 2630 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC XANTHIUM STRUMARIUM POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; RUMEX CRISPUS POLLEN; RUMEX ACETOSELLA POLLEN 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Increased Histamine Release [PE],Allergens [Chemical/Ingredient] N 20181231 65044-2677_f565c537-c530-4986-8902-de677259a766 65044-2677 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Willow, Black Salix nigra Willow, Black Salix nigra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2678_f2e07713-b01c-47bb-94e5-2819b2b1b115 65044-2678 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Willow, Black Salix nigra Willow, Black Salix nigra INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALIX NIGRA POLLEN .05 g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2679_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2679 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Willow, Black Salix nigra Willow, Black Salix nigra INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALIX NIGRA POLLEN 500 [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2854_0d773b77-2d02-4d17-a022-203c78a53d49 65044-2854 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 5 Tree Mix 5 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN; ACER SACCHARUM POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN .05; .017; .017; .017; .017; .017; .017; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2855_f565c537-c530-4986-8902-de677259a766 65044-2855 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 5 Tree Mix 5 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN; ACER SACCHARUM POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2856_f565c537-c530-4986-8902-de677259a766 65044-2856 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 5 Tree Mix 5 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN; ACER SACCHARUM POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN .1; .033; .033; .033; .033; .033; .033; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2857_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2857 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 5 Tree Mix 5 INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN; ACER SACCHARUM POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN 500; 500; 500; 500; 500; 500; 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2858_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2858 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 5 Tree Mix 5 INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARYA ILLINOINENSIS POLLEN; ACER SACCHARUM POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; QUERCUS RUBRA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN; SALIX NIGRA POLLEN .05; .017; .017; .017; .017; .017; .017; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2859_a1acb2ee-6daa-4bc7-ba3b-ffef7f9e68e5 65044-2859 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 6 Tree Mix 6 INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA PENDULA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN .05; .05; .017; .017; .017; .05; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2860_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-2860 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 6 Tree Mix 6 INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA PENDULA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN 500; 500; 500; 500; 500; 500; 500; 500 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2861_f565c537-c530-4986-8902-de677259a766 65044-2861 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 6 Tree Mix 6 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA PENDULA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN .1; .1; .033; .033; .033; .1; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2862_f565c537-c530-4986-8902-de677259a766 65044-2862 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 6 Tree Mix 6 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA PENDULA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN 20000; 20000; 20000; 20000; 20000; 20000; 20000; 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-2863_f565c537-c530-4986-8902-de677259a766 65044-2863 NON-STANDARDIZED ALLERGENIC Pollens - Trees, Tree Mix 6 Tree Mix 6 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FRAXINUS AMERICANA POLLEN; FAGUS GRANDIFOLIA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA NIGRA POLLEN; BETULA PENDULA POLLEN; JUGLANS NIGRA POLLEN; POPULUS DELTOIDES POLLEN; ULMUS AMERICANA POLLEN .05; .05; .017; .017; .017; .05; .05; .05 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-3014_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3014 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Almond Prunus amygdalus Almond Prunus amygdalus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALMOND .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3015_372626ae-d019-469a-896a-c2a94eb1b233 65044-3015 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Almond Prunus amygdalus Almond Prunus amygdalus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALMOND .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3020_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3020 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Apple Malus sp. Apple Malus sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC APPLE .1 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 65044-3021_372626ae-d019-469a-896a-c2a94eb1b233 65044-3021 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Apple Malus sp. Apple Malus sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC APPLE .1 g/mL Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 65044-3041_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3041 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Banana Musa sapientum Banana Musa sapientum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BANANA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 65044-3042_372626ae-d019-469a-896a-c2a94eb1b233 65044-3042 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Banana Musa sapientum Banana Musa sapientum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BANANA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 65044-3074_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-3074 NON-STANDARDIZED ALLERGENIC Food - Plant Source, String Bean Mix String Bean Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC STRING BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 65044-3075_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3075 NON-STANDARDIZED ALLERGENIC Food - Plant Source, String Bean Mix String Bean Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC STRING BEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 65044-3077_461a6945-2e1f-48bf-bde6-e330aa1d22fa 65044-3077 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Beef Bovine spp. Beef Bovine spp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BEEF .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 65044-3078_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-3078 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Beef Bovine spp. Beef Bovine spp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BEEF .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 65044-3107_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3107 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Brazil Nut Bertholletia excelsa Brazil Nut Bertholletia excelsa INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BRAZIL NUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3108_372626ae-d019-469a-896a-c2a94eb1b233 65044-3108 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Brazil Nut Bertholletia excelsa Brazil Nut Bertholletia excelsa INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BRAZIL NUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3116_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3116 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Melon, Cantaloupe Cucumis melo Cantaloupe Cucumis melo INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANTALOUPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 65044-3117_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3117 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Melon, Cantaloupe Cucumis melo Cantaloupe Cucumis melo INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANTALOUPE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 65044-3125_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3125 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Carrot Daucus carota Carrot Daucus carota INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARROT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 65044-3126_372626ae-d019-469a-896a-c2a94eb1b233 65044-3126 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Carrot Daucus carota Carrot Daucus carota INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CARROT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 65044-3134_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3134 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Cashew Nut Anacardium occidentalie Cashew Nut Anacardium occidentalie INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CASHEW .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3135_372626ae-d019-469a-896a-c2a94eb1b233 65044-3135 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Cashew Nut Anacardium occidentalie Cashew Nut Anacardium occidentalie INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CASHEW .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3140_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3140 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Celery Apium graveolens Celery Apium graveolens INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CELERY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 65044-3141_372626ae-d019-469a-896a-c2a94eb1b233 65044-3141 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Celery Apium graveolens Celery Apium graveolens INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CELERY .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 65044-3173_461a6945-2e1f-48bf-bde6-e330aa1d22fa 65044-3173 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Chicken Meat Gallus sp. Chicken Meat Gallus sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POULTRY, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] N 20181231 65044-3174_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-3174 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Chicken Meat Gallus sp. Chicken Meat Gallus sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POULTRY, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Poultry Proteins [Chemical/Ingredient] N 20181231 65044-3191_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3191 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Clam Clam INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUAHOG, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 65044-3192_372626ae-d019-469a-896a-c2a94eb1b233 65044-3192 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Clam Clam INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC QUAHOG, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 65044-3203_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3203 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Codfish Gadus callarias Codfish Gadus callarias INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC COD, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 65044-3204_372626ae-d019-469a-896a-c2a94eb1b233 65044-3204 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Codfish Gadus callarias Codfish Gadus callarias INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC COD, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 65044-3212_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3212 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Corn Zea mays Corn Zea mays INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 65044-3213_372626ae-d019-469a-896a-c2a94eb1b233 65044-3213 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Corn Zea mays Corn Zea mays INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CORN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 65044-3215_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3215 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Crab Xiphosurus sowerbyi Crab Xiphosurus sowerbyi INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CRAB LEG, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 65044-3216_372626ae-d019-469a-896a-c2a94eb1b233 65044-3216 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Crab Xiphosurus sowerbyi Crab Xiphosurus sowerbyi INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CRAB LEG, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 65044-3248_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3248 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Egg, White Gallus sp. Egg, White Gallus sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EGG WHITE .05 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] N 20181231 65044-3249_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-3249 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Egg, White Gallus sp. Egg, White Gallus sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EGG WHITE .05 g/mL Cell-mediated Immunity [PE],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Allergens [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient] N 20181231 65044-3254_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3254 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Egg, Yolk Gallus sp. Egg, Yolk Gallus sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EGG YOLK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] N 20181231 65044-3255_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-3255 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Egg, Yolk Gallus sp. Egg, Yolk Gallus sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EGG YOLK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Egg Proteins, Dietary [Chemical/Ingredient] N 20181231 65044-3305_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3305 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Hazelnut Filbert Corylus spp. Hazelnut Filbert Corylus spp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC HAZELNUT, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3306_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3306 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Hazelnut Filbert Corylus spp. Hazelnut Filbert Corylus spp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC HAZELNUT, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3362_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3362 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Lobster Homarus americanus Lobster Homarus americanus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LOBSTER, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 65044-3363_372626ae-d019-469a-896a-c2a94eb1b233 65044-3363 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Lobster Homarus americanus Lobster Homarus americanus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC LOBSTER, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 65044-3380_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3380 NON-STANDARDIZED ALLERGENIC Food - Dairy Products, Casein, Cow Milk Casein, Cow Milk INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CASEIN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] N 20181231 65044-3381_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-3381 NON-STANDARDIZED ALLERGENIC Food - Dairy Products, Casein, Cow Milk Casein, Cow Milk INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CASEIN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Caseins [Chemical/Ingredient] N 20181231 65044-3389_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3389 NON-STANDARDIZED ALLERGENIC Food - Dairy Products, Milk, Whole Cow Milk, Whole Cow INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC COW MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] N 20181231 65044-3390_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-3390 NON-STANDARDIZED ALLERGENIC Food - Dairy Products, Milk, Whole Cow Milk, Whole Cow INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC COW MILK .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Milk Proteins [Chemical/Ingredient] N 20181231 65044-3428_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3428 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Orange Citrus sinensis Orange Citrus sinensis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ORANGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 65044-3429_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3429 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Orange Citrus sinensis Orange Citrus sinensis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ORANGE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 65044-3449_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3449 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Pea, Green or English Pisum sativum Pea, Green or English Pisum sativum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 65044-3450_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3450 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Pea, Green or English Pisum sativum Pea, Green or English Pisum sativum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PEA .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 65044-3452_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3452 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Peach Prunus persica Peach Prunus persica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PEACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 65044-3453_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3453 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Peach Prunus persica Peach Prunus persica INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PEACH .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 65044-3455_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3455 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Peanut Arachis hypogaea Peanut Arachis hypogaea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PEANUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3456_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3456 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Peanut Arachis hypogaea Peanut Arachis hypogaea INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PEANUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3461_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3461 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Pecan Carya illinoensis Pecan Carya illinoensis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PECAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3462_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3462 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Pecan Carya illinoensis Pecan Carya illinoensis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PECAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3509_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3509 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Pork Sus sp. Pork Sus sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PORK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 65044-3510_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-3510 NON-STANDARDIZED ALLERGENIC Food - Animal Products and Poultry Products, Pork Sus sp. Pork Sus sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PORK .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Meat Proteins [Chemical/Ingredient] N 20181231 65044-3518_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3518 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Potato, White Solanum tuberosum Potato, White Solanum tuberosum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 65044-3519_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3519 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Potato, White Solanum tuberosum Potato, White Solanum tuberosum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC POTATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 65044-3548_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3548 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Rice, Whole Grain Rice, Whole Grain INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BROWN RICE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 65044-3549_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3549 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Rice, Whole Grain Rice, Whole Grain INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BROWN RICE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 65044-3554_132a4c74-bae1-4cc4-b443-6ad6efaf93fb 65044-3554 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Rye Grain Rye Grain INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RYE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 65044-3555_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3555 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Rye Grain Rye Grain INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RYE .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Grain Proteins [Chemical/Ingredient] N 20181231 65044-3564_372626ae-d019-469a-896a-c2a94eb1b233 65044-3564 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Salmon Salmo salar Salmon Salmo salar INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALMON, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 65044-3565_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3565 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Salmon Salmo salar Salmon Salmo salar INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SALMON, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 65044-3584_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3584 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Shrimp Crago sp. Shrimp Crago sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SHRIMP, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 65044-3585_372626ae-d019-469a-896a-c2a94eb1b233 65044-3585 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Shrimp Crago sp. Shrimp Crago sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SHRIMP, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Shellfish Proteins [Chemical/Ingredient] N 20181231 65044-3596_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-3596 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Soybean Glycine soja Soybean Glycine soja INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOYBEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 65044-3597_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3597 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Soybean Glycine soja Soybean Glycine soja INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOYBEAN .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 65044-3626_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-3626 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Strawberry Fragaria chiloensis Strawberry Fragaria chiloensis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC STRAWBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 65044-3627_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3627 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Strawberry Fragaria chiloensis Strawberry Fragaria chiloensis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC STRAWBERRY .05 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fruit Proteins [Chemical/Ingredient] N 20181231 65044-3656_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-3656 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Tomato Nicotiana spp. Tomato Nicotiana spp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TOMATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 65044-3657_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3657 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Tomato Nicotiana spp. Tomato Nicotiana spp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TOMATO .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] N 20181231 65044-3674_4060ca74-1c55-4b6e-b6b0-22cb06d5d08c 65044-3674 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Tuna Thunnus sp. Tuna Thunnus sp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TUNA, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 65044-3675_372626ae-d019-469a-896a-c2a94eb1b233 65044-3675 NON-STANDARDIZED ALLERGENIC Food - Fish and Shellfish, Tuna Thunnus sp. Tuna Thunnus sp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TUNA, UNSPECIFIED .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Fish Proteins, Dietary [Chemical/Ingredient] N 20181231 65044-3695_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-3695 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLACK WALNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3696_856ef228-2f68-461e-92e9-5b1d9685ddcb 65044-3696 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Walnut, Black Juglans nigra Walnut, Black Juglans nigra INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLACK WALNUT .1 g/mL Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Nut Proteins [Chemical/Ingredient] N 20181231 65044-3713_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-3713 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Yeast, Baker Saccharomyces cerevisiae Yeast, Baker Saccharomyces cerevisiae INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC YEAST .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20181231 65044-3714_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-3714 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Yeast, Baker Saccharomyces cerevisiae Yeast, Baker Saccharomyces cerevisiae INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC YEAST .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20181231 65044-3716_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-3716 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Yeast, Brewer Saccharomyces cerevisiae Yeast, Brewer Saccharomyces cerevisiae INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC YEAST .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20181231 65044-3717_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-3717 NON-STANDARDIZED ALLERGENIC Food - Plant Source, Yeast, Brewer Saccharomyces cerevisiae Yeast, Brewer Saccharomyces cerevisiae INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC YEAST .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20181231 65044-4083_461a6945-2e1f-48bf-bde6-e330aa1d22fa 65044-4083 NON-STANDARDIZED ALLERGENIC Animal Allergens, Dog Hair and Dander Canis spp. Dog Hair Canis spp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS DANDER .05; .05 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient] N 20181231 65044-4084_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-4084 NON-STANDARDIZED ALLERGENIC Animal Allergens, Dog Hair and Dander Canis spp. Dog Hair Canis spp. INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS DANDER .05; .05 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient] N 20181231 65044-4085_461a6945-2e1f-48bf-bde6-e330aa1d22fa 65044-4085 NON-STANDARDIZED ALLERGENIC Animal Allergens, Dog Hair and Dander Canis spp. Dog Hair Canis spp. INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS DANDER .05; .05 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient] N 20181231 65044-4349_461a6945-2e1f-48bf-bde6-e330aa1d22fa 65044-4349 NON-STANDARDIZED ALLERGENIC Animal Allergens, Feather Mix Feather Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] N 20181231 65044-4350_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-4350 NON-STANDARDIZED ALLERGENIC Animal Allergens, Feather Mix Feather Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] N 20181231 65044-4351_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-4351 NON-STANDARDIZED ALLERGENIC Animal Allergens, Feather Mix Feather Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC GALLUS GALLUS FEATHER; ANSER ANSER FEATHER; ANAS PLATYRHYNCHOS FEATHER 200; 200; 200 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] N 20181231 65044-4352_461a6945-2e1f-48bf-bde6-e330aa1d22fa 65044-4352 NON-STANDARDIZED ALLERGENIC Animal Allergens, Feather Mix Feather Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased IgG Production [PE] N 20181231 65044-4401_461a6945-2e1f-48bf-bde6-e330aa1d22fa 65044-4401 NON-STANDARDIZED ALLERGENIC Animal Allergens, Guinea Pig Hair and Dander Guinea Pig Hair and Dander INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CAVIA PORCELLUS HAIR; CAVIA PORCELLUS DANDER .05; .05 g/mL; g/mL Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] N 20181231 65044-4402_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-4402 NON-STANDARDIZED ALLERGENIC Animal Allergens, Guinea Pig Hair and Dander Guinea Pig Hair and Dander INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CAVIA PORCELLUS HAIR; CAVIA PORCELLUS DANDER .05; .05 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-4810_3d226a1f-f445-413d-8c3b-81bf51545e6a 65044-4810 STANDARDIZED ALLERGENIC Standardized Cat Pelt Standardized Cat Pelt INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19921020 BLA BLA103890 Jubilant HollisterStier LLC FELIS CATUS DANDER 10000 [BAU]/mL N 20181231 65044-4811_461a6945-2e1f-48bf-bde6-e330aa1d22fa 65044-4811 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Cattle Hair and Dander Cattle Hair and Dander INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19780130 BLA BLA103888 Jubilant HollisterStier LLC BOS TAURUS HAIR; BOS TAURUS DANDER .01; .01 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-4812_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-4812 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Cattle Hair and Dander Cattle Hair and Dander INJECTION, SOLUTION PERCUTANEOUS 19780130 BLA BLA103888 Jubilant HollisterStier LLC BOS TAURUS HAIR; BOS TAURUS DANDER .01; .01 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-4813_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-4813 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Cattle Hair and Dander Cattle Hair and Dander INJECTION, SOLUTION INTRADERMAL 19780130 BLA BLA103888 Jubilant HollisterStier LLC BOS TAURUS HAIR; BOS TAURUS DANDER .0005; .0005 g/mL; g/mL Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Fur [Chemical/Ingredient] N 20181231 65044-4815_b533c30c-574a-4127-9f22-471f8f10a3d8 65044-4815 STANDARDIZED ALLERGENIC Standardized Cat Hair Standardized Cat Hair INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19920924 BLA BLA103889 Jubilant HollisterStier LLC FELIS CATUS HAIR 10000 [BAU]/mL Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Salivary Proteins and Peptides [Chemical/Ingredient] N 20181231 65044-4824_461a6945-2e1f-48bf-bde6-e330aa1d22fa 65044-4824 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Dog Hair and Dander Canis spp Animal Allergens, Dog Dander Canis spp INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19760824 BLA BLA103888 Jubilant HollisterStier LLC CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS DANDER .005; .005 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient] N 20181231 65044-4825_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-4825 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Dog Hair and Dander Canis spp Animal Allergens, Dog Dander Canis spp INJECTION, SOLUTION PERCUTANEOUS 19760824 BLA BLA103888 Jubilant HollisterStier LLC CANIS LUPUS FAMILIARIS HAIR; CANIS LUPUS FAMILIARIS DANDER .005; .005 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient],Cells, Epidermal [Chemical/Ingredient] N 20181231 65044-4855_461a6945-2e1f-48bf-bde6-e330aa1d22fa 65044-4855 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Horse Hair and Dander AP Horse Hair and Dander INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19780130 BLA BLA103888 Jubilant HollisterStier LLC EQUUS CABALLUS HAIR; EQUUS CABALLUS DANDER .01; .01 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-4856_d4f568a7-ab30-48b9-8e56-486dd404550d 65044-4856 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Horse Hair and Dander AP Horse Hair and Dander INJECTION, SOLUTION PERCUTANEOUS 19780130 BLA BLA103888 Jubilant HollisterStier LLC EQUUS CABALLUS HAIR; EQUUS CABALLUS DANDER .01; .01 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-4857_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-4857 NON-STANDARDIZED ALLERGENIC Animal Allergens, AP Horse Hair and Dander AP Horse Hair and Dander INJECTION, SOLUTION INTRADERMAL 19780130 BLA BLA103888 Jubilant HollisterStier LLC EQUUS CABALLUS HAIR; EQUUS CABALLUS DANDER .0005; .0005 g/mL; g/mL Non-Standardized Animal Hair Allergenic Extract [EPC],Cell-mediated Immunity [PE],Increased Histamine Release [PE],Increased IgG Production [PE],Fur [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Animal Dander Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [Chemical/Ingredient],Dander [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5000_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5000 NON-STANDARDIZED ALLERGENIC Molds - Mold Mix 4 Molds - Mold Mix 4 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM GLAUCUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLONOSTACHYS ROSEA F. ROSEA .1; .025; .025; .025; .025; .1; .025; .025; .025; .025; .025 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5001_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5001 NON-STANDARDIZED ALLERGENIC Molds - Mold Mix 4 Molds - Mold Mix 4 INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM GLAUCUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLONOSTACHYS ROSEA F. ROSEA 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5002_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-5002 NON-STANDARDIZED ALLERGENIC Molds - Mold Mix 4 Molds - Mold Mix 4 INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLONOSTACHYS ROSEA F. ROSEA .1; .025; .025; .025; .025; .1; .025; .05; .025; .025 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5003_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-5003 NON-STANDARDIZED ALLERGENIC Molds - Alternaria/Hormodendrum Mix Molds - Alternaria/Hormodendrum Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; CLADOSPORIUM CLADOSPORIOIDES .1; .1 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5004_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5004 NON-STANDARDIZED ALLERGENIC Molds - Alternaria/Hormodendrum Mix Molds - Alternaria/Hormodendrum Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; CLADOSPORIUM CLADOSPORIOIDES .1; .1 g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5008_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5008 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Alternaria tenuis Alternaria tenuis INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5009_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-5009 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Alternaria tenuis Alternaria tenuis INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5010_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5010 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Alternaria tenuis Alternaria tenuis INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5020_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5020 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5021_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-5021 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ASPERGILLUS FUMIGATUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5022_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5022 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Aspergillus fumigatus Aspergillus fumigatus INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ASPERGILLUS FUMIGATUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5032_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5032 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Aspergillus niger Aspergillus niger INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5033_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-5033 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Aspergillus niger Aspergillus niger INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ASPERGILLUS NIGER VAR. NIGER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5048_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5048 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5049_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-5049 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Botrytis cinerea Botrytis cinerea INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BOTRYTIS CINEREA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5052_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5052 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Candida albicans Candida albicans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANDIDA ALBICANS .1 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 65044-5053_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5053 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Candida albicans Candida albicans INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANDIDA ALBICANS .1 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 65044-5054_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5054 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Candida albicans Candida albicans INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANDIDA ALBICANS 1000 [PNU]/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 65044-5055_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5055 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Candida albicans Candida albicans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CANDIDA ALBICANS .001 g/mL Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE] N 20181231 65044-5056_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5056 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Cephalosporium acremonium Cephalosporium acremonium INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SAROCLADIUM STRICTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5057_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5057 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Cephalosporium acremonium Cephalosporium acremonium INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SAROCLADIUM STRICTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5058_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5058 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Cephalosporium acremonium Cephalosporium acremonium INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC SAROCLADIUM STRICTUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5076_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5076 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Curvularia spicifera Curvularia spicifera INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC COCHLIOBOLUS SPICIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5077_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5077 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Curvularia spicifera Curvularia spicifera INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC COCHLIOBOLUS SPICIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5078_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5078 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Curvularia spicifera Curvularia spicifera INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC COCHLIOBOLUS SPICIFER 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5100_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5100 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 65044-5101_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5101 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EPICOCCUM NIGRUM .1 g/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 65044-5102_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5102 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Epicoccum nigrum Epicoccum nigrum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC EPICOCCUM NIGRUM 1000 [PNU]/mL Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE] N 20181231 65044-5104_e4502b15-1610-4791-9d15-05e91bcd6579 65044-5104 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Epidermophyton floccosum Epidermophyton floccosum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EPIDERMOPHYTON FLOCCOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5105_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5105 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Epidermophyton floccosum Epidermophyton floccosum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC EPIDERMOPHYTON FLOCCOSUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5112_e4502b15-1610-4791-9d15-05e91bcd6579 65044-5112 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Fusarium vasinfectum Fusarium vasinfectum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FUSARIUM OXYSPORUM VASINFECTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5113_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5113 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Fusarium vasinfectum Fusarium vasinfectum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC FUSARIUM OXYSPORUM VASINFECTUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5114_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5114 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Fusarium vasinfectum Fusarium vasinfectum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC FUSARIUM OXYSPORUM VASINFECTUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5124_e4502b15-1610-4791-9d15-05e91bcd6579 65044-5124 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Helminthosporium interseminatum Helminthosporium interseminatum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC DENDRYPHIELLA VINOSA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5125_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5125 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Helminthosporium interseminatum Helminthosporium interseminatum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC DENDRYPHIELLA VINOSA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5126_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5126 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Helminthosporium interseminatum Helminthosporium interseminatum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC DENDRYPHIELLA VINOSA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5128_e4502b15-1610-4791-9d15-05e91bcd6579 65044-5128 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Hormodendrum cladosporioides Hormodendrum cladosporioides INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5129_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5129 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Hormodendrum cladosporioides Hormodendrum cladosporioides INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC CLADOSPORIUM CLADOSPORIOIDES .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5130_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5130 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Hormodendrum cladosporioides Hormodendrum cladosporioides INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC CLADOSPORIUM CLADOSPORIOIDES 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5136_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5136 NON-STANDARDIZED ALLERGENIC Molds - Mold Mix 10 Molds - Mold Mix 10 INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; FUSARIUM OXYSPORUM VASINFECTUM; DENDRYPHIELLA VINOSA; CLADOSPORIUM CLADOSPORIOIDES; MUCOR RACEMOSUS; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM GLAUCUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLONOSTACHYS ROSEA F. ROSEA; PHOMA EXIGUA VAR. EXIGUA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER .1; .025; .025; .025; .025; .1; .1; .1; .1; .02; .02; .02; .02; .02; .1; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5137_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-5137 NON-STANDARDIZED ALLERGENIC Molds - Mold Mix 10 Molds - Mold Mix 10 INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; FUSARIUM OXYSPORUM VASINFECTUM; DENDRYPHIELLA VINOSA; CLADOSPORIUM CLADOSPORIOIDES; MUCOR RACEMOSUS; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLONOSTACHYS ROSEA F. ROSEA; PHOMA EXIGUA VAR. EXIGUA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER .1; .025; .025; .025; .025; .1; .1; .1; .1; .02; .04; .02; .02; .1; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5138_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5138 NON-STANDARDIZED ALLERGENIC Molds - Mold Mix 10 Molds - Mold Mix 10 INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; ASPERGILLUS TERREUS; FUSARIUM OXYSPORUM VASINFECTUM; DENDRYPHIELLA VINOSA; CLADOSPORIUM CLADOSPORIOIDES; MUCOR RACEMOSUS; PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM GLAUCUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLONOSTACHYS ROSEA F. ROSEA; PHOMA EXIGUA VAR. EXIGUA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000; 1000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient] N 20181231 65044-5144_e4502b15-1610-4791-9d15-05e91bcd6579 65044-5144 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Mucor racemosus Mucor racemosus INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MUCOR RACEMOSUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5145_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5145 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Mucor racemosus Mucor racemosus INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC MUCOR RACEMOSUS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5146_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5146 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Mucor racemosus Mucor racemosus INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC MUCOR RACEMOSUS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5168_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5168 NON-STANDARDIZED ALLERGENIC Molds, Penicillium Mix Molds, Penicillium Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM GLAUCUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLONOSTACHYS ROSEA F. ROSEA .1; .1; .1; .1; .1 g/mL; g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5169_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-5169 NON-STANDARDIZED ALLERGENIC Molds, Penicillium Mix Molds, Penicillium Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLONOSTACHYS ROSEA F. ROSEA .1; .2; .1; .1 g/mL; g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5170_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5170 NON-STANDARDIZED ALLERGENIC Molds, Penicillium Mix Molds, Penicillium Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PENICILLIUM DIGITATUM; PENICILLIUM EXPANSUM; PENICILLIUM GLAUCUM; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; CLONOSTACHYS ROSEA F. ROSEA 1000; 1000; 1000; 1000; 1000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dietary Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Fungal Proteins [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5208_e4502b15-1610-4791-9d15-05e91bcd6579 65044-5208 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Penicillium notatum Penicillium notatum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5209_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5209 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Penicillium notatum Penicillium notatum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5210_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5210 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Penicillium notatum Penicillium notatum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5220_e4502b15-1610-4791-9d15-05e91bcd6579 65044-5220 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Phoma herbarum Phoma herbarum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PHOMA EXIGUA VAR. EXIGUA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5221_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5221 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Phoma herbarum Phoma herbarum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PHOMA EXIGUA VAR. EXIGUA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5222_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5222 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Phoma herbarum Phoma herbarum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PHOMA EXIGUA VAR. EXIGUA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5230_e4502b15-1610-4791-9d15-05e91bcd6579 65044-5230 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Rhizopus nigricans Rhizopus nigricans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RHIZOPUS STOLONIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5231_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5231 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Rhizopus nigricans Rhizopus nigricans INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC RHIZOPUS STOLONIFER 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5232_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5232 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Rhizopus nigricans Rhizopus nigricans INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC RHIZOPUS STOLONIFER .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5233_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5233 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Pullularia pullulans Pullularia pullulans INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AUREOBASIDIUM PULLULANS VAR. PULLUTANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5234_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5234 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Pullularia pullulans Pullularia pullulans INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC AUREOBASIDIUM PULLULANS VAR. PULLUTANS 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5235_e4502b15-1610-4791-9d15-05e91bcd6579 65044-5235 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Pullularia pullulans Pullularia pullulans INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC AUREOBASIDIUM PULLULANS VAR. PULLUTANS .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5264_e4502b15-1610-4791-9d15-05e91bcd6579 65044-5264 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Stemphylium botryosum Stemphylium botryosum INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLEOSPORA TARDA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5265_f981d4bc-3d16-493e-bf9d-5ac7e005ea67 65044-5265 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Stemphylium botryosum Stemphylium botryosum INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLEOSPORA TARDA .1 g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5266_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5266 NON-STANDARDIZED ALLERGENIC Molds, Rusts and Smuts, Stemphylium botryosum Stemphylium botryosum INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PLEOSPORA TARDA 1000 [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5284_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-5284 NON-STANDARDIZED ALLERGENIC Molds - Trichophyton Mix Molds - Trichophyton Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TRICHOPHYTON TONSURANS; TRICHOPHYTON RUBRUM; TRICHOPHYTON MENTAGROPHYTES .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5285_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-5285 NON-STANDARDIZED ALLERGENIC Molds - Trichophyton Mix Molds - Trichophyton Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC TRICHOPHYTON TONSURANS; TRICHOPHYTON RUBRUM; TRICHOPHYTON MENTAGROPHYTES .1; .1; .1 g/mL; g/mL; g/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-5286_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-5286 NON-STANDARDIZED ALLERGENIC Molds - Trichophyton Mix Molds - Trichophyton Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC TRICHOPHYTON TONSURANS; TRICHOPHYTON RUBRUM; TRICHOPHYTON MENTAGROPHYTES 1000; 1000; 1000 [PNU]/mL; [PNU]/mL; [PNU]/mL Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6513_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-6513 NON-STANDARDIZED ALLERGENIC Insects Whole Body, Ant, Fire Solenopsis Invicta Ant, Fire Solenopsis Invicta INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLENOPSIS INVICTA .1 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6514_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-6514 NON-STANDARDIZED ALLERGENIC Insects Whole Body, Ant, Fire Solenopsis richteri Ant, Fire Solenopsis richteri INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLENOPSIS RICHTERI .1 g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6515_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-6515 NON-STANDARDIZED ALLERGENIC Insects whole body, Fire Ant Mix Insects whole body, Fire Ant Mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLENOPSIS RICHTERI; SOLENOPSIS INVICTA .1; .1 g/mL; g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6516_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-6516 NON-STANDARDIZED ALLERGENIC Insects whole body, Fire Ant Mix Insects whole body, Fire Ant Mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLENOPSIS RICHTERI; SOLENOPSIS INVICTA 500; 500 [PNU]/mL; [PNU]/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6517_f27bd8f7-4a87-4676-9a47-7d42df763275 65044-6517 NON-STANDARDIZED ALLERGENIC Insects whole body, Fire Ant Mix Insects whole body, Fire Ant Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLENOPSIS RICHTERI; SOLENOPSIS INVICTA .1; .1 g/mL; g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6518_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-6518 NON-STANDARDIZED ALLERGENIC Insects whole body, Fire Ant Mix Insects whole body, Fire Ant Mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC SOLENOPSIS RICHTERI; SOLENOPSIS INVICTA .1; .1 g/mL; g/mL Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Ant Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6580_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-6580 NON-STANDARDIZED ALLERGENIC Insects whole body cockroach, American Periplaneta americana Insects whole body cockroach, American Periplaneta americana INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PERIPLANETA AMERICANA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6581_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-6581 NON-STANDARDIZED ALLERGENIC Insects whole body Cockroach, German Blatella germanica Insects whole body Cockroach, German Blatella germanica INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC BLATELLA GERMANICA .1 g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6584_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-6584 NON-STANDARDIZED ALLERGENIC Insects whole body cockroach mix Insects whole body cockroach mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PERIPLANETA AMERICANA; BLATELLA GERMANICA .1; .1 g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6585_54335583-1e55-4098-bb10-ce5bba70f2ac 65044-6585 NON-STANDARDIZED ALLERGENIC Insects whole body cockroach mix Insects whole body cockroach mix INJECTION, SOLUTION PERCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PERIPLANETA AMERICANA; BLATELLA GERMANICA .1; .1 g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6586_82ac2ac3-f59f-4261-9c7e-82571afc59df 65044-6586 NON-STANDARDIZED ALLERGENIC Insects whole body cockroach mix Insects whole body cockroach mix INJECTION, SOLUTION INTRADERMAL 19410419 BLA BLA103888 Jubilant HollisterStier LLC PERIPLANETA AMERICANA; BLATELLA GERMANICA 500; 500 [PNU]/mL; [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6587_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-6587 NON-STANDARDIZED ALLERGENIC Insects whole body cockroach mix Insects whole body cockroach mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PERIPLANETA AMERICANA; BLATELLA GERMANICA .1; .1 g/mL; g/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6588_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-6588 NON-STANDARDIZED ALLERGENIC Insects whole body cockroach mix Insects whole body cockroach mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PERIPLANETA AMERICANA; BLATELLA GERMANICA 20000; 20000 [PNU]/mL; [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6589_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-6589 NON-STANDARDIZED ALLERGENIC Insects whole body cockroach mix Insects whole body cockroach mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PERIPLANETA AMERICANA; BLATELLA GERMANICA 20000; 20000 [PNU]/mL; [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6590_c652b773-aeb8-44a6-a764-cbb581fd76af 65044-6590 NON-STANDARDIZED ALLERGENIC Insects whole body cockroach mix Insects whole body cockroach mix INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19410419 BLA BLA103888 Jubilant HollisterStier LLC PERIPLANETA AMERICANA; BLATELLA GERMANICA 5000; 5000 [PNU]/mL; [PNU]/mL Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6690_092e20db-098e-44d2-80e1-2245115ac7ce 65044-6690 STANDARDIZED ALLERGENIC Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 30000 AU per mL Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 30000 AU per mL INJECTION, SOLUTION SUBCUTANEOUS 19880526 BLA BLA103870 Jubilant HollisterStier LLC DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 15000; 15000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6691_092e20db-098e-44d2-80e1-2245115ac7ce 65044-6691 STANDARDIZED ALLERGENIC Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL INJECTION, SOLUTION SUBCUTANEOUS 19880526 BLA BLA103870 Jubilant HollisterStier LLC DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS 5000; 5000 [AU]/mL; [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6692_092e20db-098e-44d2-80e1-2245115ac7ce 65044-6692 STANDARDIZED ALLERGENIC Standardized Mite, Dermatophagoides pteronyssinus, Scratch or Bulk, 30000 AU per mL Standardized Mite, Dermatophagoides pteronyssinus, Scratch or Bulk, 30000 AU per mL INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19880526 BLA BLA103871 Jubilant HollisterStier LLC DERMATOPHAGOIDES PTERONYSSINUS 30000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6693_092e20db-098e-44d2-80e1-2245115ac7ce 65044-6693 STANDARDIZED ALLERGENIC Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 30 AU per mL Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 30 AU per mL INJECTION, SOLUTION INTRADERMAL 19880526 BLA BLA103871 Jubilant HollisterStier LLC DERMATOPHAGOIDES PTERONYSSINUS 30 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6694_092e20db-098e-44d2-80e1-2245115ac7ce 65044-6694 STANDARDIZED ALLERGENIC Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 300 AU per mL Standardized Mite, Dermatophagoides pteronyssinus, Intradermal, 300 AU per mL INJECTION, SOLUTION INTRADERMAL 19880526 BLA BLA103871 Jubilant HollisterStier LLC DERMATOPHAGOIDES PTERONYSSINUS 300 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6695_092e20db-098e-44d2-80e1-2245115ac7ce 65044-6695 STANDARDIZED ALLERGENIC Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL Standardized Mite, Dermatophagoides pteronyssinus, Bulk, 10000 AU per mL INJECTION, SOLUTION SUBCUTANEOUS 19880526 BLA BLA103871 Jubilant HollisterStier LLC DERMATOPHAGOIDES PTERONYSSINUS 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6720_092e20db-098e-44d2-80e1-2245115ac7ce 65044-6720 STANDARDIZED ALLERGENIC Standardized Mite, Dermatophagoides farinae, Scratch or Bulk, 30000 AU per mL Standardized Mite, Dermatophagoides farinae, Scratch or Bulk, 30000 AU per mL INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19880526 BLA BLA103870 Jubilant HollisterStier LLC DERMATOPHAGOIDES FARINAE 30000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6721_092e20db-098e-44d2-80e1-2245115ac7ce 65044-6721 STANDARDIZED ALLERGENIC Standardized Mite, Dermatophagoides farinae, Intradermal, 30 AU per mL Standardized Mite, Dermatophagoides farinae, Intradermal, 30 AU per mL INJECTION, SOLUTION INTRADERMAL 19880526 BLA BLA103870 Jubilant HollisterStier LLC DERMATOPHAGOIDES FARINAE 30 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6722_092e20db-098e-44d2-80e1-2245115ac7ce 65044-6722 STANDARDIZED ALLERGENIC Standardized Mite, Dermatophagoides farinae, Intradermal, 300 AU per mL Standardized Mite, Dermatophagoides farinae, Intradermal, 300 AU per mL INJECTION, SOLUTION INTRADERMAL 19880526 BLA BLA103870 Jubilant HollisterStier LLC DERMATOPHAGOIDES FARINAE 300 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-6723_092e20db-098e-44d2-80e1-2245115ac7ce 65044-6723 STANDARDIZED ALLERGENIC Standardized Mite, Dermatophagoides farinae, Bulk, 10000 AU per mL Standardized Mite, Dermatophagoides farinae, Bulk, 10000 AU per mL INJECTION, SOLUTION SUBCUTANEOUS 19880526 BLA BLA103870 Jubilant HollisterStier LLC DERMATOPHAGOIDES FARINAE 10000 [AU]/mL Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [Chemical/Ingredient],Insect Proteins [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-7131_91d0c953-5702-42ed-a6d6-2b65a4cc1741 65044-7131 HUMAN PRESCRIPTION DRUG sodium chloride sodium chloride INJECTION, SOLUTION INTRAVENOUS 20160229 ANDA ANDA203352 Jubilant HollisterStier LLC SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 65044-7133_91d0c953-5702-42ed-a6d6-2b65a4cc1741 65044-7133 HUMAN PRESCRIPTION DRUG sodium chloride sodium chloride INJECTION, SOLUTION INTRAVENOUS 20160229 ANDA ANDA203352 Jubilant HollisterStier LLC SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 65044-9940_e1b141c9-1157-48a6-814b-f5fad26eff12 65044-9940 STANDARDIZED ALLERGENIC Honey Bee hymenoptera venom Multidose Honey Bee hymenoptera venom Multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19791016 BLA BLA103882 Jubilant HollisterStier LLC APIS MELLIFERA VENOM 100 ug/mL N 20181231 65044-9941_e1b141c9-1157-48a6-814b-f5fad26eff12 65044-9941 STANDARDIZED ALLERGENIC White Faced Hornet Hymenoptera Venom Multidose White Faced Hornet Hymenoptera Venom Multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19791016 BLA BLA103885 Jubilant HollisterStier LLC DOLICHOVESPULA MACULATA VENOM PROTEIN 100 ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-9942_e1b141c9-1157-48a6-814b-f5fad26eff12 65044-9942 STANDARDIZED ALLERGENIC Yellow Hornet hymenoptera venom Multidose Yellow Hornet hymenoptera venom Multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19791016 BLA BLA103886 Jubilant HollisterStier LLC DOLICHOVESPULA ARENARIA VENOM PROTEIN 100 ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-9943_e1b141c9-1157-48a6-814b-f5fad26eff12 65044-9943 STANDARDIZED ALLERGENIC Wasp hymenoptera venom Multidose Wasp hymenoptera venom Multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19791016 BLA BLA103884 Jubilant HollisterStier LLC POLISTES ANNULARIS VENOM PROTEIN; POLISTES EXCLAMANS VENOM PROTEIN; POLISTES FUSCATUS VENOM PROTEIN; POLISTES METRICUS VENOM PROTEIN 25; 25; 25; 25 ug/mL; ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-9944_e1b141c9-1157-48a6-814b-f5fad26eff12 65044-9944 STANDARDIZED ALLERGENIC Yellow Jacket hymenoptera venom Multidose Yellow Jacket hymenoptera venom Multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19791016 BLA BLA103887 Jubilant HollisterStier LLC VESPULA GERMANICA VENOM PROTEIN; VESPULA MACULIFRONS VENOM PROTEIN; VESPULA PENSYLVANICA VENOM PROTEIN; VESPULA SQUAMOSA VENOM PROTEIN; VESPULA VULGARIS VENOM PROTEIN 20; 20; 20; 20; 20 ug/mL; ug/mL; ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-9945_e1b141c9-1157-48a6-814b-f5fad26eff12 65044-9945 STANDARDIZED ALLERGENIC Mixed Vespid Hymenoptera Venom Multidose Mixed Vespid Hymenoptera Venom Multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19801211 BLA BLA103883 Jubilant HollisterStier LLC DOLICHOVESPULA MACULATA VENOM PROTEIN; DOLICHOVESPULA ARENARIA VENOM PROTEIN; VESPULA GERMANICA VENOM PROTEIN; VESPULA MACULIFRONS VENOM PROTEIN; VESPULA PENSYLVANICA VENOM PROTEIN; VESPULA SQUAMOSA VENOM PROTEIN; VESPULA VULGARIS VENOM PROTEIN 100; 100; 20; 20; 20; 20; 20 ug/mL; ug/mL; ug/mL; ug/mL; ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-9950_ed89077e-16ae-40b9-bec3-b9fc7ed3d007 65044-9950 STANDARDIZED ALLERGENIC honey bee hymenoptera venom multidose honey bee hymenoptera venom multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19950411 BLA BLA103882 Jubilant HollisterStier LLC APIS MELLIFERA VENOM 100 ug/mL N 20181231 65044-9951_ed89077e-16ae-40b9-bec3-b9fc7ed3d007 65044-9951 STANDARDIZED ALLERGENIC white faced hornet hymenoptera venom multidose white faced hornet hymenoptera venom multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19950411 BLA BLA103885 Jubilant HollisterStier LLC DOLICHOVESPULA MACULATA VENOM PROTEIN 100 ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-9953_ed89077e-16ae-40b9-bec3-b9fc7ed3d007 65044-9953 STANDARDIZED ALLERGENIC wasp hymenoptera venom multidose wasp hymenoptera venom multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19950411 BLA BLA103884 Jubilant HollisterStier LLC POLISTES ANNULARIS VENOM PROTEIN; POLISTES EXCLAMANS VENOM PROTEIN; POLISTES FUSCATUS VENOM PROTEIN; POLISTES METRICUS VENOM PROTEIN 25; 25; 25; 25 ug/mL; ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-9954_ed89077e-16ae-40b9-bec3-b9fc7ed3d007 65044-9954 STANDARDIZED ALLERGENIC yellow jacket hymenoptera venom multidose yellow jacket hymenoptera venom multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19950411 BLA BLA103887 Jubilant HollisterStier LLC VESPULA GERMANICA VENOM PROTEIN; VESPULA MACULIFRONS VENOM PROTEIN; VESPULA PENSYLVANICA VENOM PROTEIN; VESPULA SQUAMOSA VENOM PROTEIN; VESPULA VULGARIS VENOM PROTEIN 20; 20; 20; 20; 20 ug/mL; ug/mL; ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-9955_ed89077e-16ae-40b9-bec3-b9fc7ed3d007 65044-9955 STANDARDIZED ALLERGENIC mixed vespid hymenoptera venom multidose mixed vespid hymenoptera venom multidose INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 19950411 BLA BLA103883 Jubilant HollisterStier LLC DOLICHOVESPULA MACULATA VENOM PROTEIN; DOLICHOVESPULA ARENARIA VENOM PROTEIN; VESPULA GERMANICA VENOM PROTEIN; VESPULA MACULIFRONS VENOM PROTEIN; VESPULA PENSYLVANICA VENOM PROTEIN; VESPULA SQUAMOSA VENOM PROTEIN; VESPULA VULGARIS VENOM PROTEIN 100; 100; 20; 20; 20; 20; 20 ug/mL; ug/mL; ug/mL; ug/mL; ug/mL; ug/mL; ug/mL Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Wasp Venoms [Chemical/Ingredient],Allergens [Chemical/Ingredient] N 20181231 65044-9960_3f2d15f0-4d27-4350-8c92-72cc7a8ac296 65044-9960 STANDARDIZED ALLERGENIC Honey Bee hymenoptera venom Venomil Diagnostic Honey Bee hymenoptera venom Venomil Diagnostic KIT PERCUTANEOUS 19820222 BLA BLA103882 Jubilant HollisterStier LLC N 20181231 65044-9961_3f2d15f0-4d27-4350-8c92-72cc7a8ac296 65044-9961 STANDARDIZED ALLERGENIC White Faced Hornet hymenoptera venom Venomil Diagnostic White Faced Hornet hymenoptera venom Venomil Diagnostic KIT PERCUTANEOUS 19820222 BLA BLA103885 Jubilant HollisterStier LLC N 20181231 65044-9962_3f2d15f0-4d27-4350-8c92-72cc7a8ac296 65044-9962 STANDARDIZED ALLERGENIC Yellow Hornet hymenoptera venom Venomil Diagnostic Yellow Hornet hymenoptera venom Venomil Diagnostic KIT PERCUTANEOUS 19820222 BLA BLA103886 Jubilant HollisterStier LLC N 20181231 65044-9963_3f2d15f0-4d27-4350-8c92-72cc7a8ac296 65044-9963 STANDARDIZED ALLERGENIC Wasp hymenoptera venom Venomil Diagnostic Wasp hymenoptera venom Venomil Diagnostic KIT PERCUTANEOUS 19820222 BLA BLA103884 Jubilant HollisterStier LLC N 20181231 65044-9964_3f2d15f0-4d27-4350-8c92-72cc7a8ac296 65044-9964 STANDARDIZED ALLERGENIC Yellow Jacket hymenoptera venom Venomil Diagnostic Yellow Jacket hymenoptera venom Venomil Diagnostic KIT PERCUTANEOUS 19820222 BLA BLA103887 Jubilant HollisterStier LLC N 20181231 65044-9970_3f2d15f0-4d27-4350-8c92-72cc7a8ac296 65044-9970 STANDARDIZED ALLERGENIC Honey Bee hymenoptera venom Venomil Maintenance Honey Bee hymenoptera venom Venomil Maintenance KIT SUBCUTANEOUS 19820222 BLA BLA103882 Jubilant HollisterStier LLC N 20181231 65044-9971_3f2d15f0-4d27-4350-8c92-72cc7a8ac296 65044-9971 STANDARDIZED ALLERGENIC White Faced Hornet hymenoptera venom Venomil Maintenance White Faced Hornet hymenoptera venom Venomil Maintenance KIT SUBCUTANEOUS 19820222 BLA BLA103885 Jubilant HollisterStier LLC N 20181231 65044-9972_3f2d15f0-4d27-4350-8c92-72cc7a8ac296 65044-9972 STANDARDIZED ALLERGENIC Yellow Hornet hymenoptera venom Venomil Maintenance Yellow Hornet hymenoptera venom Venomil Maintenance KIT SUBCUTANEOUS 19820222 BLA BLA103886 Jubilant HollisterStier LLC N 20181231 65044-9973_3f2d15f0-4d27-4350-8c92-72cc7a8ac296 65044-9973 STANDARDIZED ALLERGENIC Wasp hymenoptera venom Venomil Maintenance Wasp hymenoptera venom Venomil Maintenance KIT SUBCUTANEOUS 19820222 BLA BLA103884 Jubilant HollisterStier LLC N 20181231 65044-9974_3f2d15f0-4d27-4350-8c92-72cc7a8ac296 65044-9974 STANDARDIZED ALLERGENIC Yellow Jacket hymenoptera venom Venomil Maintenance Yellow Jacket hymenoptera venom Venomil Maintenance KIT SUBCUTANEOUS 19820222 BLA BLA103887 Jubilant HollisterStier LLC N 20181231 65044-9975_3f2d15f0-4d27-4350-8c92-72cc7a8ac296 65044-9975 STANDARDIZED ALLERGENIC Mixed Vespid hymenoptera venom Venomil Maintenance Mixed Vespid hymenoptera venom Venomil Maintenance KIT SUBCUTANEOUS 19820222 BLA BLA103883 Jubilant HollisterStier LLC N 20181231 65044-9990_673b931b-9404-4888-bd30-fb6b18a66ea9 65044-9990 HUMAN PRESCRIPTION DRUG Diluent for Allergenic Extract - Sterile Normal Saline with Phenol Normal Saline with Phenol INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19790801 BLA BLA103888 Hollister-Stier Laboratories LLC E 20171231 65044-9991_673b931b-9404-4888-bd30-fb6b18a66ea9 65044-9991 HUMAN PRESCRIPTION DRUG Diluent for Allergenic Extract - Sterile Normal Saline with Phenol Normal Saline with Phenol INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19790801 BLA BLA103888 Hollister-Stier Laboratories LLC E 20171231 65044-9992_885ee89c-5dff-4b30-b950-66eb6fe426de 65044-9992 HUMAN PRESCRIPTION DRUG Diluent for Allergenic Extract - Sterile Buffered Saline with Phenol Buffered Saline with Phenol INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19790801 BLA BLA103888 Hollister-Stier Laboratories LLC E 20171231 65044-9993_705e463b-0088-4028-9033-0dde85cfc6cb 65044-9993 HUMAN PRESCRIPTION DRUG Diluent for Allergenic Extract - Sterile Albumin Saline with Phenol Albumin Saline with Phenol INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19790801 BLA BLA103888 Hollister-Stier Laboratories LLC E 20171231 65044-9996_705e463b-0088-4028-9033-0dde85cfc6cb 65044-9996 HUMAN PRESCRIPTION DRUG Diluent for Allergenic Extract - Sterile Albumin Saline with Phenol Albumin Saline with Phenol INJECTION, SOLUTION PERCUTANEOUS; SUBCUTANEOUS 19790801 BLA BLA103888 Hollister-Stier Laboratories LLC N 20181231 65044-9998_a2020bf7-7dab-4534-8731-3d8fb8d8bfdd 65044-9998 HUMAN PRESCRIPTION DRUG Positive Skin Test Control - Histamine Histamine INJECTION PERCUTANEOUS 19950615 BLA BLA103891 Jubilant HollisterStier LLC HISTAMINE 6 mg/mL N 20181231 65055-101_3b72d624-57fd-2ca5-e054-00144ff88e88 65055-101 HUMAN OTC DRUG Iodine Tincture Iodine Tincture TINCTURE TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. IODINE; SODIUM IODIDE 2; 2.4 g/100mL; g/100mL N 20181231 65055-102_3d0ae362-3793-21b1-e054-00144ff88e88 65055-102 HUMAN OTC DRUG Iodine Tincture Iodine Tincture SPRAY TOPICAL 20160921 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. IODINE; SODIUM IODIDE 2; 2.4 g/100mL; g/100mL N 20181231 65055-201_3b7233fc-a570-29e4-e054-00144ff88e88 65055-201 HUMAN OTC DRUG Mertodol Solution Benzalkonium Chloride LIQUID TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 65055-202_3d0b01af-c082-497f-e054-00144ff8d46c 65055-202 HUMAN OTC DRUG Mertodol Solution Benzalkonium Chloride SPRAY TOPICAL 20160921 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 65055-301_3b7316c0-585a-4ba5-e054-00144ff88e88 65055-301 HUMAN OTC DRUG White Mertodol Benzalkonium Chloride LIQUID TOPICAL 20130925 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 65055-302_3d0ad12e-3955-2cec-e054-00144ff88e88 65055-302 HUMAN OTC DRUG White Mertodol Benzalkonium Chloride SPRAY TOPICAL 20160921 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 65055-401_3e1717af-cb87-4e61-8ef9-345e2a58d458 65055-401 HUMAN OTC DRUG Gentian Violet Topical Solution Gentian Violet LIQUID TOPICAL 20130927 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. GENTIAN VIOLET 1 g/100mL N 20181231 65055-501_2fbe50c9-c8ec-13fe-e054-00144ff88e88 65055-501 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20130918 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. HYDROGEN PEROXIDE 30 mg/mL N 20181231 65055-601_fe035e9f-e8da-467a-862d-49fc265cf4bc 65055-601 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20130927 OTC MONOGRAPH NOT FINAL part333A Laboratorios Jaloma, S.A. de C.V. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 65055-701_ceab72e6-5332-4d57-ad6d-aac45ec33fb4 65055-701 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part333 Laboratorios Jaloma, S.A. de C.V. ALCOHOL 64 g/100mL N 20181231 65067-321_647ae7ea-c9f1-4d66-bb56-195ba3e52928 65067-321 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20020101 UNAPPROVED MEDICAL GAS Hampton Homecare OXYGEN 99 L/100L E 20171231 65076-0001_9643b457-b528-4dc1-bb0d-573552299660 65076-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20081001 UNAPPROVED MEDICAL GAS Advanced Health Services, Inc. OXYGEN 99 L/100L E 20171231 65076-101_8372edcf-62dc-4fe6-90d5-be8422ab92b0 65076-101 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19990101 UNAPPROVED MEDICAL GAS Bickett Machine and Supply, Inc OXYGEN 99 L/100L E 20171231 65084-123_0f4e771f-b317-4220-8391-dfcfb83bd479 65084-123 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE TABLET ORAL 20140526 UNAPPROVED DRUG OTHER RxPak Division of McKesson Corporation PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 65084-135_8318e45c-d260-4cb2-9a69-7b12f1bf0dd3 65084-135 HUMAN PRESCRIPTION DRUG DYAZIDE hydrochlorothiazide and triamterene CAPSULE ORAL 19940330 NDA NDA016042 Mckesson Rxpak Inc HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] E 20171231 65084-288_0d975eaa-17ff-4222-a897-ed7d37bfd1db 65084-288 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitatrate and Acetaminophen TABLET ORAL 20130312 ANDA ANDA040148 Mckesson Rxpak Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 65084-298_81152a6d-7c01-432e-a811-f3ffb00435fa 65084-298 HUMAN PRESCRIPTION DRUG PERCOCET oxycodone hydrochloride and acetaminophen TABLET ORAL 19990630 ANDA ANDA040330 Mckesson Rxpak Inc OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 65084-308_6d30aea8-0971-438f-b1eb-bdd067d23165 65084-308 HUMAN PRESCRIPTION DRUG Klonopin Clonazepam TABLET ORAL 19750602 NDA NDA017533 Mckesson Rxpak Inc CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65084-309_6d30aea8-0971-438f-b1eb-bdd067d23165 65084-309 HUMAN PRESCRIPTION DRUG Klonopin Clonazepam TABLET ORAL 19750602 NDA NDA017533 Mckesson Rxpak Inc CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65084-312_0d244298-ddd3-4db3-b9b1-ce91d6bd558e 65084-312 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 19631115 NDA NDA013263 Mckesson Rxpak Inc DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65084-313_0d244298-ddd3-4db3-b9b1-ce91d6bd558e 65084-313 HUMAN PRESCRIPTION DRUG Valium diazepam TABLET ORAL 19631115 NDA NDA013263 Mckesson Rxpak Inc DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65084-440_41858c95-2f6b-4e6f-b2ad-c7c2e1068d43 65084-440 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET ORAL 19560101 NDA NDA019892 Mckesson Rxpak Inc HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 65084-441_ca9151b1-bf9a-495f-bfe1-529fc28475dc 65084-441 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Mckesson Rxpak Inc LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 65084-442_ca9151b1-bf9a-495f-bfe1-529fc28475dc 65084-442 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Mckesson Rxpak Inc LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 65084-443_ca9151b1-bf9a-495f-bfe1-529fc28475dc 65084-443 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Mckesson Rxpak Inc LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 65084-453_1aee5ab4-6f3d-44f4-952b-0a2aa7915679 65084-453 HUMAN PRESCRIPTION DRUG Hydrocodone Bitatrate and Acetaminophen Hydrocodone Bitatrate and Acetaminophen TABLET ORAL 20130312 ANDA ANDA040148 Mckesson Rxpak Inc HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 65084-454_a77650bb-2df3-4635-a545-0baf790bfa33 65084-454 HUMAN PRESCRIPTION DRUG Fioricet Butalbital, Acetaminophen, and Caffeine CAPSULE ORAL 20130729 ANDA ANDA040885 Mckesson Rxpak Inc BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 300; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 65084-455_509fb279-dc81-4029-8383-16acc9afcdc9 65084-455 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Mckesson Rxpak Inc DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 65084-456_c3eb47b7-1f64-4ed5-8f94-251c9202c254 65084-456 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20110119 ANDA ANDA075135 Mckesson Rxpak Inc AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 65084-457_ef7f5ccc-c93b-47b3-a915-3e76610073a8 65084-457 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 Mckesson Rxpak Inc LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65084-458_ef7f5ccc-c93b-47b3-a915-3e76610073a8 65084-458 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 Mckesson Rxpak Inc LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65084-459_ef7f5ccc-c93b-47b3-a915-3e76610073a8 65084-459 HUMAN PRESCRIPTION DRUG Keppra levetiracetam TABLET, FILM COATED ORAL 20000424 NDA NDA021035 Mckesson Rxpak Inc LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65084-460_194d444f-6e9a-46fb-a4d4-750f93dfc80e 65084-460 HUMAN PRESCRIPTION DRUG Keppra XR levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080924 NDA NDA022285 Mckesson Rxpak Inc LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65084-461_194d444f-6e9a-46fb-a4d4-750f93dfc80e 65084-461 HUMAN PRESCRIPTION DRUG Keppra XR levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090401 NDA NDA022285 Mckesson Rxpak Inc LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65084-462_e5029392-88d4-44fd-b863-5570459db3fb 65084-462 HUMAN PRESCRIPTION DRUG ALBENZA albendazole TABLET, FILM COATED ORAL 19960611 NDA NDA020666 Mckesson Rxpak Inc ALBENDAZOLE 200 mg/1 Antihelminthic [EPC],Cytochrome P450 1A Inducers [MoA] N 20181231 65084-463_69a48e27-469e-49af-bed9-e8b9bd752291 65084-463 HUMAN PRESCRIPTION DRUG Ativan lorazepam TABLET ORAL 20130501 NDA NDA017794 Mckesson Rxpak Inc LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65084-464_83915d85-63ab-4fb9-887c-fa19853a44bc 65084-464 HUMAN PRESCRIPTION DRUG KLOR-CON potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140901 NDA NDA019123 Mckesson Rxpak Inc POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 65084-465_83915d85-63ab-4fb9-887c-fa19853a44bc 65084-465 HUMAN PRESCRIPTION DRUG KLOR-CON potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140901 NDA NDA019123 Mckesson Rxpak Inc POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 65084-466_3a4eeb7c-d91f-4bf4-b614-ceb89dae7925 65084-466 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20060321 NDA NDA021259 Mckesson Rxpak Inc METHYLPHENIDATE HYDROCHLORIDE 40 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 65084-467_3a4eeb7c-d91f-4bf4-b614-ceb89dae7925 65084-467 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030812 NDA NDA021259 Mckesson Rxpak Inc METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 65084-468_3a4eeb7c-d91f-4bf4-b614-ceb89dae7925 65084-468 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030218 NDA NDA021259 Mckesson Rxpak Inc METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 65084-469_3a4eeb7c-d91f-4bf4-b614-ceb89dae7925 65084-469 HUMAN PRESCRIPTION DRUG Metadate CD methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20030722 NDA NDA021259 Mckesson Rxpak Inc METHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 65084-470_a0a56d6b-4109-43ac-8530-e342d4c2b3f8 65084-470 HUMAN PRESCRIPTION DRUG Lortab 5/325 hydrocodone bitartrate and acetaminophen TABLET ORAL 20140421 ANDA ANDA202214 RxPak Division of McKesson Corp. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 65084-471_a0a56d6b-4109-43ac-8530-e342d4c2b3f8 65084-471 HUMAN PRESCRIPTION DRUG Lortab 7.5/325 hydrocodone bitartrate and acetaminophen TABLET ORAL 20140421 ANDA ANDA202214 RxPak Division of McKesson Corp. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 65084-472_a0a56d6b-4109-43ac-8530-e342d4c2b3f8 65084-472 HUMAN PRESCRIPTION DRUG Lortab 10/325 hydrocodone bitartrate and acetaminophen TABLET ORAL 20140421 ANDA ANDA202214 RxPak Division of McKesson Corp. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 65084-474_f22429d1-5a9e-4286-a856-8104e188e35e 65084-474 HUMAN PRESCRIPTION DRUG Canasa Mesalamine SUPPOSITORY RECTAL 20010105 NDA NDA021252 Mckesson Rxpak Inc MESALAMINE 1000 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 65111-005_6f3aeb72-02cb-4dae-8981-74fc7b61a521 65111-005 HUMAN OTC DRUG Arnica Montana 30X HPUS Arnica Montana, TABLET ORAL 20140213 UNAPPROVED HOMEOPATHIC Vitamedica Corporation ARNICA MONTANA 30 [hp_X]/1 N 20181231 65111-005_98dcc738-2c4a-4fc5-aae3-ab06c91f4335 65111-005 HUMAN OTC DRUG ARNICA MONTANA ARNICA MONTANA TABLET ORAL 20141117 UNAPPROVED HOMEOPATHIC VITAMEDICA INC ARNICA MONTANA 30 [hp_X]/1 N 20181231 65112-203_34e2d615-6cfd-4ca1-e054-00144ff8d46c 65112-203 HUMAN OTC DRUG Acne Treatment Cleanser Acne Treatment LIQUID TOPICAL 20150723 OTC MONOGRAPH FINAL part333D I. Shay Cosmetics SALICYLIC ACID .018 mg/mg E 20171231 65112-205_34e2172c-0d5a-6e4a-e054-00144ff88e88 65112-205 HUMAN OTC DRUG Acne Treatment Acne Treatment CREAM TOPICAL 20150713 OTC MONOGRAPH FINAL part333D I. Shay Cosmetics BENZOYL PEROXIDE .026 mg/mg E 20171231 65112-206_39d7a696-cc70-3e46-e054-00144ff88e88 65112-206 HUMAN OTC DRUG Numbing Label Lidocaine Spray SPRAY TOPICAL 20130102 OTC MONOGRAPH FINAL part346 I. Shay Cosmetics LIDOCAINE HYDROCHLORIDE .04 mg/mg E 20171231 65112-207_39dbc355-c6f9-3a38-e054-00144ff8d46c 65112-207 HUMAN OTC DRUG Numbing Hemorrhoidal Label Numbing Hemorrhoidal Spray SPRAY TOPICAL 20130102 OTC MONOGRAPH FINAL part346 I. Shay Cosmetics EPINEPHRINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE .0001; .05 mg/mg; mg/mg E 20171231 65112-209_3e018d33-8f69-48dc-e054-00144ff8d46c 65112-209 HUMAN OTC DRUG Desensitizing cream Desensitizing cream LOTION TOPICAL 20060625 OTC MONOGRAPH FINAL part346 I. Shay Cosmetics BENZOCAINE .05 g/g E 20171231 65112-210_3e02595f-f7db-033b-e054-00144ff8d46c 65112-210 HUMAN OTC DRUG Sunscreen SPF 30 Sunscreen SPF 30 LIQUID TOPICAL 20130701 OTC MONOGRAPH FINAL part352 I. Shay Cosmetics OCTINOXATE; AVOBENZONE; OCTISALATE .075; .03; .05 mg/mg; mg/mg; mg/mg E 20171231 65112-213_3e17dcbe-a1ef-44b0-e054-00144ff8d46c 65112-213 HUMAN OTC DRUG Mineral Sunscreen Mineral Sunscreen LOTION TOPICAL 20140117 OTC MONOGRAPH FINAL part352 I. Shay Cosmetics ZINC OXIDE .25 mg/mg E 20171231 65112-214_3e19e372-be04-64b0-e054-00144ff88e88 65112-214 HUMAN OTC DRUG Sunscreen 30 Sunscreen 30 CREAM TOPICAL 20130701 OTC MONOGRAPH FINAL part352 I. Shay Cosmetics OCTINOXATE; AVOBENZONE; OCTISALATE .075; .03; .05 mg/mg; mg/mg; mg/mg E 20171231 65113-2372_bd463862-faeb-4ac3-a4eb-bdf6d593737a 65113-2372 HUMAN OTC DRUG AGE INTERVENTION DUALITY BENZOYL PEROXIDE CREAM TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333D G.S. COSMECEUTICAL USA, INC. BENZOYL PEROXIDE 10 g/100g E 20171231 65113-2373_cf908a6e-f96b-4936-90ee-9ced11c2ef77 65113-2373 HUMAN OTC DRUG AGE INTERVENTION DUALITY MD BENZOYL PEROXIDE CREAM TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333D G.S. COSMECEUTICAL USA, INC. BENZOYL PEROXIDE 10 g/100g E 20171231 65113-2428_cea721f5-55b7-4f39-a15f-9c91b6f71046 65113-2428 HUMAN OTC DRUG GORILLA WARFARE ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY LOTION TOPICAL 20100430 OTC MONOGRAPH FINAL part350 G.S. COSMECEUTICAL USA, INC. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15 mL/100mL E 20171231 65113-2432_2daef8de-6967-4615-ac7a-200ed03e61e4 65113-2432 HUMAN OTC DRUG PHOTO DYNAMIC THERAPY SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 G.S. COSMECEUTICAL USA, INC. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 65113-8401_747d192d-0a31-44b3-8dff-71cb2aa196ea 65113-8401 HUMAN OTC DRUG SKIN LIGHTENING COMPLEX HYDROQUINONE CREAM TOPICAL 20091209 OTC MONOGRAPH NOT FINAL part358A G.S. COSMECEUTICAL USA, INC. HYDROQUINONE 2 g/100g E 20171231 65113-8503_f895144d-17fd-4efa-8b05-87f986871753 65113-8503 HUMAN OTC DRUG NuGLOW DAYTIME THERAPY With SPF 15 AVOBENZONE, OCTINOXATE, and ZINC OXIDE CREAM TOPICAL 20101015 OTC MONOGRAPH NOT FINAL part352 G.S. COSMECEUTICAL USA, INC. AVOBENZONE; OCTINOXATE; ZINC OXIDE 1; 7; 4 g/100g; g/100g; g/100g E 20171231 65119-345_41220e91-f261-45e6-a61b-36dc950a7ff5 65119-345 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19710101 NDA NDA205767 Bronx Welding Supply Inc OXYGEN 99 L/100L N 20191231 65121-001_d4a51445-85ca-410e-9563-0b7da9fb1b27 65121-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, METHYL SALICYLATE GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL; METHYL SALICYLATE 14; 5 mL/120mL; mL/120mL E 20171231 65121-001_d9349932-0364-4e9c-9c3a-10ed77414a80 65121-001 HUMAN OTC DRUG Cold Spot Point Relief menthol, METHYL SALICYLATE GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL; METHYL SALICYLATE 115; 38 mL/960mL; mL/960mL E 20171231 65121-001_d9351ee3-9e8e-4325-8868-c7ccb17d3c3a 65121-001 HUMAN OTC DRUG Cold Spot Point Relief menthol GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL; METHYL SALICYLATE .6; .2 g/5g; g/5g E 20171231 65121-001_e6a6f198-7521-4c66-9b2f-95a863f552ed 65121-001 HUMAN OTC DRUG Cold Spot Point Relief menthol GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL; MENTHYL SALICYLATE 58; 19 mL/480mL; mL/480mL E 20171231 65121-001_ea738ac3-347b-4fbd-a049-1893172a18e8 65121-001 HUMAN OTC DRUG Cold Spot Point Relief menthol GEL TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL .46 L/3.8L E 20171231 65121-002_d07db448-ed4d-4c49-bc25-23400c5d95bc 65121-002 HUMAN OTC DRUG Cold Spot Point Relief menthol OINTMENT TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL 13 mL/90mL E 20171231 65121-003_57ba08ba-4077-403b-b2b8-d17495d8d27f 65121-003 HUMAN OTC DRUG Cold Spot Point Relief menthol AEROSOL, SPRAY TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL 12 mL/120mL E 20171231 65121-003_aef8b744-b314-49c0-a222-973a40037471 65121-003 HUMAN OTC DRUG Cold Spot Point Relief menthol AEROSOL, SPRAY TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL 6 mL/60mL E 20171231 65121-003_d82d99d9-f506-4013-a0b5-975d6f3fd9d4 65121-003 HUMAN OTC DRUG Cold Spot Point Relief menthol AEROSOL, SPRAY TOPICAL 20100824 OTC MONOGRAPH FINAL part341 Pure Source MENTHOL 48 mL/480mL E 20171231 65121-010_088147d9-6c24-4d05-a80a-7fba5f9095e9 65121-010 HUMAN OTC DRUG Hot Spot Point Relief capsaicin GEL TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part348 Pure Source CAPSAICIN 1.5 mL/240mL E 20171231 65121-010_42f16670-ee65-4cf8-9aa2-2a7bb87a6388 65121-010 HUMAN OTC DRUG Hot Spot Point Relief capsaicin GEL TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part348 Pure Source CAPSAICIN .5 mL/90mL E 20171231 65121-010_5b607491-41a0-49c7-906a-5e991193d7f5 65121-010 HUMAN OTC DRUG Hot Spot Point Relief capsaicin GEL TOPICAL 20100824 OTC MONOGRAPH NOT FINAL part348 Pure Source CAPSAICIN 5.8 mL/960mL E 20171231 65121-100_482d946f-62cf-0db3-e054-00144ff8d46c 65121-100 HUMAN OTC DRUG Soulus Rp Rash and Pain LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part348 Pure Source, LLC LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 65121-101_482e2384-ef37-01c7-e054-00144ff88e88 65121-101 HUMAN OTC DRUG BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Women MINOXIDIL LIQUID TOPICAL 20130815 ANDA ANDA076239 Pure Source, LLC MINOXIDIL 20 mg/mL N 20181231 65121-102_482e2384-efa5-01c7-e054-00144ff88e88 65121-102 HUMAN OTC DRUG BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Men MINOXIDIL LIQUID TOPICAL 20130815 ANDA ANDA076239 Pure Source, LLC MINOXIDIL 50 mg/mL N 20181231 65121-113_490f7bc0-0fce-746a-e054-00144ff8d46c 65121-113 HUMAN OTC DRUG OxyRub Pain Relief MENTHOL CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Pure Source, LLC MENTHOL 1.25 g/100g N 20181231 65121-121_482d946f-62c3-0db3-e054-00144ff8d46c 65121-121 HUMAN OTC DRUG Arthritis Relief MENTHOL, HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20131125 OTC MONOGRAPH NOT FINAL part348 Pure Source, LLC MENTHOL; HISTAMINE DIHYDROCHLORIDE 3; .025 g/100g; g/100g N 20181231 65121-208_483061a1-d086-24b9-e054-00144ff8d46c 65121-208 HUMAN OTC DRUG Senophile Dermal PETROLATUM, COD LIVER OINTMENT TOPICAL 20141224 OTC MONOGRAPH FINAL part347 Pure Source, LLC PETROLATUM; COD LIVER OIL 40; 10 g/100g; g/100g N 20181231 65121-209_482e2384-ef5c-01c7-e054-00144ff88e88 65121-209 HUMAN OTC DRUG biochemistry PAIN RELIEF FOOT ACTIVE BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part348 Pure Source, LLC BENZYL ALCOHOL; LIDOCAINE HYDROCHLORIDE 190; 40 mg/mL; mg/mL N 20181231 65121-300_617b4611-d476-c225-e053-2991aa0aaea1 65121-300 HUMAN OTC DRUG AvaDerm lidocaine hcl, menthol CREAM TOPICAL 20150610 OTC MONOGRAPH NOT FINAL part348 Pure Source, LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g N 20181231 65121-301_617b4611-d480-c225-e053-2991aa0aaea1 65121-301 HUMAN PRESCRIPTION DRUG Vita-Rx Diabetic Vitamin Vitamin C, Vitamin D, Vitamin E, Thiamine, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Biotin, Pantothenic Acid, Chromium CAPSULE, GELATIN COATED ORAL 20150811 UNAPPROVED DRUG OTHER Pure Source, LLC ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; CHROMIUM PICOLINATE; THIOCTIC ACID; UBIDECARENONE 120; .0625; 10; 1.5; 1.7; 20; 12.5; .8; .0025; 2.5; 10; .465; 150; 50 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 65121-302_617b557c-97a3-39e7-e053-2991aa0a5c41 65121-302 HUMAN OTC DRUG VitaCin methyl salicylate, menthol, capsaicin CREAM TOPICAL 20150610 OTC MONOGRAPH NOT FINAL part348 Pure Source, LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 5; .0375 g/100g; g/100g; g/100g N 20181231 65121-397_48307b26-51da-2245-e054-00144ff8d46c 65121-397 HUMAN OTC DRUG VIRCIN Advanced wart treatment SALICYLIC ACID CREAM TOPICAL 20140612 OTC MONOGRAPH FINAL part358B Pure Source, LLC SALICYLIC ACID 17 g/100g N 20181231 65121-403_482d946f-62df-0db3-e054-00144ff8d46c 65121-403 HUMAN OTC DRUG Dr. Freds MIRACLE RUB HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20130606 OTC MONOGRAPH NOT FINAL part348 Pure Source, LLC HISTAMINE DIHYDROCHLORIDE .25 mg/mL N 20181231 65121-494_48307e03-6b34-2c66-e054-00144ff8d46c 65121-494 HUMAN OTC DRUG Jungle Screen SPF 30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part352 Pure Source, LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 65121-495_490f5cfb-7192-6f35-e054-00144ff8d46c 65121-495 HUMAN OTC DRUG LCDO. ORLANDO RIVERA ARTHRITIS Topical Analgesic METHYL SALICYLATE, MENTHOL, CAPSAICIN CREAM TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part348 Pure Source, LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN 15; 10; .05 g/100g; g/100g; g/100g N 20181231 65121-498_482e2384-ef89-01c7-e054-00144ff88e88 65121-498 HUMAN OTC DRUG CORISIN ARTHRITIS PAIN RELIEF CAPSAICIN, MENTHOL GEL TOPICAL 20140421 OTC MONOGRAPH NOT FINAL part348 Pure Source, LLC CAPSAICIN; MENTHOL .025; 10 g/100g; g/100g N 20181231 65121-562_48309692-0dbf-5e6b-e054-00144ff88e88 65121-562 HUMAN OTC DRUG KERANIQUE For Women Hair Regrowth Treatment MINOXIDIL LIQUID TOPICAL 20140206 ANDA ANDA078176 Pure Source, LLC MINOXIDIL 20 mg/mL N 20181231 65121-623_1c691b70-50c9-438e-ae19-ee9372ae690e 65121-623 HUMAN OTC DRUG Tag Away Thuja Occidentalis LIQUID TOPICAL 20120831 UNAPPROVED HOMEOPATHIC Pure Source THUJA OCCIDENTALIS WHOLE 6 [hp_X]/15mL N 20181231 65121-623_6067ef7d-b440-49c9-e053-2a91aa0af21a 65121-623 HUMAN OTC DRUG Tag Away Thuja Occidentalis LIQUID TOPICAL 20120818 UNAPPROVED HOMEOPATHIC Pure Source THUJA OCCIDENTALIS BARK 6 [hp_X]/10mL N 20181231 65121-711_482e2384-ef7a-01c7-e054-00144ff88e88 65121-711 HUMAN OTC DRUG Tag Away THUJA OCCIDENTALIS LEAFY TWIG LIQUID TOPICAL 20130522 UNAPPROVED HOMEOPATHIC Pure Source, LLC THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/mL N 20181231 65121-715_482e2384-efc5-01c7-e054-00144ff88e88 65121-715 HUMAN OTC DRUG ecolyptus pain relieving muscle rub MENTHOL CREAM TOPICAL 20140206 OTC MONOGRAPH NOT FINAL part348 Pure Source, LLC MENTHOL 60 mg/mL N 20181231 65121-789_490b74d3-7486-7170-e054-00144ff88e88 65121-789 HUMAN OTC DRUG Zeta Clear Antifungal UNDECYLENIC ACID SOLUTION TOPICAL 20170217 OTC MONOGRAPH FINAL part333C Pure Source, LLC UNDECYLENIC ACID 100 mg/mL N 20181231 65121-828_4830e546-7dda-3fb5-e054-00144ff8d46c 65121-828 HUMAN OTC DRUG PainKoolers MENTHOL, CAPSAICIN PATCH TOPICAL 20141230 OTC MONOGRAPH NOT FINAL part348 Pure Source, LLC MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g N 20181231 65121-883_482e2384-ef6b-01c7-e054-00144ff88e88 65121-883 HUMAN OTC DRUG DR. MERCOLA Sunscreen Broad Spectrum SPF-30 ZINC OXIDE CREAM TOPICAL 20140428 OTC MONOGRAPH NOT FINAL part352 Pure Source, LLC ZINC OXIDE 200 mg/mL N 20181231 65121-884_482e2384-ef28-01c7-e054-00144ff88e88 65121-884 HUMAN OTC DRUG DR. MERCOLA Sunscreen Broad Spectrum SPF-15 ZINC OXIDE CREAM TOPICAL 20140428 OTC MONOGRAPH NOT FINAL part352 Pure Source, LLC ZINC OXIDE 95 mg/mL N 20181231 65121-885_482d946f-62b5-0db3-e054-00144ff8d46c 65121-885 HUMAN OTC DRUG GranuLotion MENTHOL, ZINC OXIDE LOTION TOPICAL 20140326 OTC MONOGRAPH FINAL part346 Pure Source, LLC MENTHOL; ZINC OXIDE .11; 5.1 g/100g; g/100g N 20181231 65121-886_482e2384-ef96-01c7-e054-00144ff88e88 65121-886 HUMAN OTC DRUG DR. MERCOLA Sunscreen SPF-50 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140428 OTC MONOGRAPH NOT FINAL part352 Pure Source, LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 225 mg/mL; mg/mL N 20181231 65121-887_579b1f76-1298-684f-e053-2a91aa0a83d7 65121-887 HUMAN OTC DRUG Pain Away Solution Aconitum Nepellus Hypericum Peforatum Lycopodium Clavatum Phosphorus Rhus Toxicodendron Secale Cornutum SPRAY TOPICAL 20170825 UNAPPROVED HOMEOPATHIC Pure Source, LLC HYPERICUM PERFORATUM; LYCOPODIUM CLAVATUM SPORE; ACONITUM NAPELLUS; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM 24; 24; 24; 24; 24; 24 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL N 20181231 65131-054_7ec85034-cc70-4465-bc25-9c700731eb02 65131-054 HUMAN OTC DRUG BRONCOCHEM KIDS COLD AND FLU ACETAMINOPHEN-PHENYLEPHRINE HCl-GUAIFENESIN SYRUP ORAL 20170501 OTC MONOGRAPH FINAL part341 LABORATORIO MAGNACHEM INTERNATIONAL SRL ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN 325; 5; 200 mg/10mL; mg/10mL; mg/10mL N 20181231 65131-091_b4e75d5f-2f1c-4ea0-84f2-705fd4631199 65131-091 HUMAN OTC DRUG BRONCOCHEM MAXIMUM COUGH DEXTROMETHORPHAN HBr-GYAIFENESIN SYRUP ORAL 20161230 OTC MONOGRAPH FINAL part341 LABORATORIO MAGNACHEM INTERNATIONAL SRL DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30; 200 mg/10mL; mg/10mL E 20171231 65131-097_d810108a-90e9-4240-b030-5b8702045c2b 65131-097 HUMAN OTC DRUG BRONCOCHEM COLD AND FLU TEA ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE GRANULE, FOR SOLUTION ORAL 20130901 OTC MONOGRAPH NOT FINAL part343 LABORATORIO MAGNACHEM INTERNATIONAL SRL ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 500; 4 mg/13g; mg/13g N 20181231 65131-098_8ddc705a-c6b4-4b03-8492-d2b00eaa4b88 65131-098 HUMAN OTC DRUG BRONCOCHEM ALLERGY CONTROL Cholpheniramine maleate-Phenylephrine HCl SYRUP ORAL 20170401 OTC MONOGRAPH FINAL part341 LABORATORIO MAGNACHEM INTERNATIONAL SRL CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/10mL; mg/10mL N 20181231 65131-111_ade271a2-acb3-481c-98f6-4d6861d0737a 65131-111 HUMAN OTC DRUG BRONCOCHEM COLD AND FLU CAPLETS Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine Maleate TABLET, COATED ORAL 20100101 OTC MONOGRAPH FINAL part341 LABOTORIO MAGNACHEM INTERNATIONAL SRL ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE 325; 30; 5; 3 mg/1; mg/1; mg/1; mg/1 E 20171231 65131-116_383c518a-2d0c-4346-894c-9e089094d612 65131-116 HUMAN OTC DRUG BRONCOCHEM EXPECTORANT II ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl SYRUP ORAL 20161230 OTC MONOGRAPH NOT FINAL part343 LABORATORIO MAGNACHEM INTERNATIONAL SRL ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 250; 4; 13.33; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL E 20171231 65131-180_a0bd3860-b58b-4e71-846c-354c603d1500 65131-180 HUMAN OTC DRUG BRONCOCHEM MAXIMUM COUGH KIDS DEXTROMETHORPHAN HBr-GUAIFENESIN SYRUP ORAL 20170501 OTC MONOGRAPH FINAL part341 LABORATORIO MAGNACHEM INTERNATIONAL SRL DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/15mL; mg/15mL N 20181231 65131-418_d42910c8-7859-41af-ae13-a7e442b6924f 65131-418 HUMAN OTC DRUG BRONCOCHEM KIDS ALLERGY CONTROL Chlorpheniramine maleate-Dextromethrophan HBr SYRUP ORAL 20170501 OTC MONOGRAPH FINAL part341 LABORATORIO MAGANCEHM INTERNATIONAL SRL CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 2; 10 mg/10mL; mg/10mL N 20181231 65133-110_00cd7242-44f3-45d5-98d6-faa2a57145bb 65133-110 HUMAN OTC DRUG Aire-Master Alcohol GEL TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc. ALCOHOL 60 mL/100mL N 20181231 65133-120_c6b88516-3eac-4439-9d0a-2c1a071832dc 65133-120 HUMAN OTC DRUG Aire-Master Alcohol GEL TOPICAL 20071212 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc. ALCOHOL 62 mL/100mL N 20181231 65133-130_e2cffd30-525d-4e50-9903-23031a345e56 65133-130 HUMAN OTC DRUG Aire-Master Sanitizer Gel vit e/a Alcohol GEL TOPICAL 19980101 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc ALCOHOL 60 mL/100mL N 20181231 65133-140_1a02eda6-798b-435d-84d3-bd64a8021e0f 65133-140 HUMAN OTC DRUG Aire-Master Alcohol GEL TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc. ALCOHOL 70 mL/100mL N 20181231 65133-150_c825bcc7-a25b-4b3c-a0ac-d07b49e8d4a7 65133-150 HUMAN OTC DRUG Aire-Master Alcohol LIQUID TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc. ALCOHOL 60 mL/100mL N 20181231 65133-160_a4ef7848-fffa-40c8-9bb3-113a323d9c8e 65133-160 HUMAN OTC DRUG Aire-Master Liquid spray handsanitizer LIQUID TOPICAL 20120507 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc. ALCOHOL 62 mL/100mL N 20181231 65133-170_2d41ebb4-8182-47c0-9a33-d0cad51b7345 65133-170 HUMAN OTC DRUG Aire-Master Foaming AB handsoap TRICLOSAN LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc. TRICLOSAN .3 g/10mL N 20181231 65133-180_4bcb0135-6c82-4310-ae16-e49c5b68015c 65133-180 HUMAN OTC DRUG Aire-Master Antibacterial Liquid Handsoap Triclosan LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333E Aire-Master of America, Inc. TRICLOSAN .3 g/10mL N 20181231 65133-190_69edbda0-5413-4ab7-9d00-1b051f33e3b5 65133-190 HUMAN OTC DRUG Aire-Master Foaming AB Triclosan Free BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Aire-Master of America, Inc. BENZALKONIUM CHLORIDE .13 g/10mL N 20181231 65133-200_29d74faf-39df-459a-beec-9c47f22ce221 65133-200 HUMAN OTC DRUG Aire-Master Alcohol Free Foaming Sanitizer BENZALKONIUM CHLORIDE AEROSOL, FOAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part333A Aire-Master of America, Inc. BENZALKONIUM CHLORIDE .1 g/10mL N 20181231 65141-0001_6c7ca8db-9b07-41aa-b9a8-24a7d73ab774 65141-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990524 UNAPPROVED MEDICAL GAS CareFirst of Fort Wayne, Inc. dba Advanced Healthcare OXYGEN 99 L/100L E 20171231 65156-515_329e7cc1-9fe7-4345-8ef5-128ae22cb3cb 65156-515 HUMAN OTC DRUG Hygiene Master Instant Hand Sanitizer ethanol GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Kayline Company ETHANOL 600 mL/1000mL E 20171231 65162-003_0809525e-f24a-433c-8bbc-a78b5bb828b1 65162-003 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine SOLUTION ORAL 20091007 ANDA ANDA090765 Amneal Pharmaceuticals of New York, LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 65162-005_ccc909d6-06a3-4103-ac59-d77e42928abe 65162-005 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine SOLUTION ORAL 20091007 ANDA ANDA090765 Amneal Pharmaceuticals of New York, LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 65162-006_3edc4a36-19ef-4063-8dcd-fbafe76935f1 65162-006 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100621 ANDA ANDA078477 Amneal Pharmaceuticals LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65162-007_3edc4a36-19ef-4063-8dcd-fbafe76935f1 65162-007 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100621 ANDA ANDA078477 Amneal Pharmaceuticals LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65162-008_3edc4a36-19ef-4063-8dcd-fbafe76935f1 65162-008 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100621 ANDA ANDA078477 Amneal Pharmaceuticals LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65162-019_0bb71073-ace6-44de-8d26-564676ecb92c 65162-019 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate TABLET, FILM COATED ORAL 20170517 ANDA ANDA205619 Amneal Pharmaceuticals LLC ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65162-020_0bb71073-ace6-44de-8d26-564676ecb92c 65162-020 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate TABLET, FILM COATED ORAL 20170517 ANDA ANDA205619 Amneal Pharmaceuticals LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65162-021_0bb71073-ace6-44de-8d26-564676ecb92c 65162-021 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate TABLET, FILM COATED ORAL 20170517 ANDA ANDA205619 Amneal Pharmaceuticals LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65162-033_f8ea7ec5-ab4d-48af-97f1-2675e696dd76 65162-033 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 Amneal Pharmaceuticals LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 65162-034_f7139c20-edb3-40a8-9cdc-684c38970323 65162-034 HUMAN PRESCRIPTION DRUG Omega-3-Acid Ethyl Esters Omega-3-Acid Ethyl Esters CAPSULE, LIQUID FILLED ORAL 20151130 ANDA ANDA204940 Amneal Pharmaceuticals LLC OMEGA-3-ACID ETHYL ESTERS 1 g/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 65162-042_5046692f-dfbd-486a-9860-ed92ff067cdd 65162-042 HUMAN PRESCRIPTION DRUG Eletriptan Hydrobromide Eletriptan Hydrobromide TABLET, FILM COATED ORAL 20170901 ANDA ANDA206787 Amneal Pharmaceuticals LLC ELETRIPTAN HYDROBROMIDE MONOHYDRATE 20 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65162-043_5046692f-dfbd-486a-9860-ed92ff067cdd 65162-043 HUMAN PRESCRIPTION DRUG Eletriptan Hydrobromide Eletriptan Hydrobromide TABLET, FILM COATED ORAL 20170901 ANDA ANDA206787 Amneal Pharmaceuticals LLC ELETRIPTAN HYDROBROMIDE MONOHYDRATE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65162-045_118c2ce0-2573-4de8-861a-3da2bb79e97a 65162-045 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine TABLET ORAL 20100121 ANDA ANDA078780 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 65162-046_4061bbde-90e8-446f-b2d9-678879549866 65162-046 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine TABLET ORAL 20100121 ANDA ANDA078780 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 65162-047_b8168438-f108-4a97-bdf4-f2b96e1368ba 65162-047 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone TABLET ORAL 20121030 ANDA ANDA203638 Amneal Pharmaceuticals LLC OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 65162-048_b8168438-f108-4a97-bdf4-f2b96e1368ba 65162-048 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone TABLET ORAL 20121030 ANDA ANDA203638 Amneal Pharmaceuticals LLC OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 65162-049_b8168438-f108-4a97-bdf4-f2b96e1368ba 65162-049 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone TABLET ORAL 20121030 ANDA ANDA203638 Amneal Pharmaceuticals LLC OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 65162-050_b8168438-f108-4a97-bdf4-f2b96e1368ba 65162-050 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone TABLET ORAL 20121030 ANDA ANDA203638 Amneal Pharmaceuticals LLC OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 65162-051_b8168438-f108-4a97-bdf4-f2b96e1368ba 65162-051 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone TABLET ORAL 20121030 ANDA ANDA203638 Amneal Pharmaceuticals LLC OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 65162-052_ec582571-af7d-4076-b738-e9c093e12fb4 65162-052 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100406 ANDA ANDA077289 Amneal Pharmaceuticals LLC CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65162-053_ec582571-af7d-4076-b738-e9c093e12fb4 65162-053 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100406 ANDA ANDA077289 Amneal Pharmaceuticals LLC CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65162-054_ec582571-af7d-4076-b738-e9c093e12fb4 65162-054 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100406 ANDA ANDA077289 Amneal Pharmaceuticals LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65162-057_6025e081-968e-418a-a447-d826d8fb0386 65162-057 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20160120 ANDA ANDA208206 Amneal Pharmaceuticals of New York, LLC RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 65162-058_d323a9aa-72cc-4fd8-ba60-ef93f43d6c78 65162-058 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate Sevelamer Carbonate TABLET, FILM COATED ORAL 20171128 ANDA ANDA207288 Amneal Pharmaceuticals LLC SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 65162-087_0ed7ce10-f5b9-46c5-a447-0fe6d78929da 65162-087 HUMAN PRESCRIPTION DRUG Itraconazole Itraconazole SOLUTION ORAL 20140430 ANDA ANDA205573 Amneal Pharmaceuticals LLC ITRACONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 65162-101_ef495a2a-f0a4-48f9-aaac-8e686882e14d 65162-101 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Amneal Pharmaceuticals LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 65162-102_ef495a2a-f0a4-48f9-aaac-8e686882e14d 65162-102 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Amneal Pharmaceuticals LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 65162-103_ef495a2a-f0a4-48f9-aaac-8e686882e14d 65162-103 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Amneal Pharmaceuticals LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 65162-115_fbb4da61-872d-4265-a1dc-e893ece2855e 65162-115 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160630 ANDA ANDA040746 Amneal Pharmaceuticals LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 65162-145_be2bac86-6f22-471d-a517-c7b7a6e5995b 65162-145 HUMAN OTC DRUG Cetirizine Hydrochloride Hives Relief Cetirizine TABLET ORAL 20100121 ANDA ANDA078780 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 65162-146_36129c76-bfc7-4f3f-89bd-935bf221f9d6 65162-146 HUMAN OTC DRUG Cetirizine Hydrochloride Hives Relief Cetirizine TABLET ORAL 20100121 ANDA ANDA078780 Amneal Pharmaceuticals CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 65162-174_6fc4d215-86ac-416e-8e9a-5f84b78ef2db 65162-174 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin TABLET ORAL 20090601 ANDA ANDA077880 Amneal Pharmaceuticals METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 65162-175_6fc4d215-86ac-416e-8e9a-5f84b78ef2db 65162-175 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin TABLET ORAL 20090601 ANDA ANDA077880 Amneal Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65162-177_6fc4d215-86ac-416e-8e9a-5f84b78ef2db 65162-177 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin TABLET ORAL 20090601 ANDA ANDA077880 Amneal Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 65162-188_986f5640-90ad-464a-9a9e-b3c605df07be 65162-188 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Amneal Pharmaceuticals LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65162-189_986f5640-90ad-464a-9a9e-b3c605df07be 65162-189 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Amneal Pharmaceuticals LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65162-190_986f5640-90ad-464a-9a9e-b3c605df07be 65162-190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Amneal Pharmaceuticals LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65162-193_de245649-8256-43b2-a4ea-0c7732b45238 65162-193 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Amneal Pharmaceuticals LLC NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65162-194_de245649-8256-43b2-a4ea-0c7732b45238 65162-194 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Amneal Pharmaceuticals LLC NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65162-207_e31e9319-2440-4f9b-8336-6f27a3418169 65162-207 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20131101 ANDA ANDA040778 Amneal Pharmaceuticals LLC OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 65162-209_95b772aa-9fb1-4ab2-abef-2bb9ed6b2687 65162-209 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET ORAL 20140430 ANDA ANDA078195 Amneal Pharmaceuticals of New York, LLC NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 65162-212_78eb2749-7c9b-4742-ab04-02eb4338fbda 65162-212 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20091216 ANDA ANDA040765 Amneal Pharmaceuticals LLC PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 65162-218_ed51b4e5-7414-4348-a040-8206f6c288f1 65162-218 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 Amneal Pharmaceuticals of New York, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65162-219_ed51b4e5-7414-4348-a040-8206f6c288f1 65162-219 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 Amneal Pharmaceuticals of New York, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65162-220_ed51b4e5-7414-4348-a040-8206f6c288f1 65162-220 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20121217 ANDA ANDA077880 Amneal Pharmaceuticals of New York, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65162-226_0f96aa8c-ebe5-4260-88af-556270fa89c8 65162-226 HUMAN PRESCRIPTION DRUG YUVAFEM Estradiol TABLET VAGINAL 20161017 ANDA ANDA205256 Amneal Pharmaceuticals, LLC ESTRADIOL 10 ug/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 65162-248_edba56d3-3a17-4c8c-8bf2-c18020ea0eb6 65162-248 HUMAN PRESCRIPTION DRUG Alosetron Hydrochloride Alosetron Hydrochloride TABLET, FILM COATED ORAL 20170102 ANDA ANDA206647 Amneal Pharmaceuticals LLC ALOSETRON HYDROCHLORIDE .5 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 65162-249_edba56d3-3a17-4c8c-8bf2-c18020ea0eb6 65162-249 HUMAN PRESCRIPTION DRUG Alosetron Hydrochloride Alosetron Hydrochloride TABLET, FILM COATED ORAL 20170102 ANDA ANDA206647 Amneal Pharmaceuticals LLC ALOSETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 65162-253_d4fb0e0e-4b47-40b9-8fcb-e19e0c49f66c 65162-253 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Amneal Pharmaceuticals LLC RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 65162-254_d4fb0e0e-4b47-40b9-8fcb-e19e0c49f66c 65162-254 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Amneal Pharmaceuticals LLC RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 65162-300_db45897b-3d2a-4902-8383-de8de5397e37 65162-300 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Amneal Pharmaceuticals, LLC VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65162-302_db45897b-3d2a-4902-8383-de8de5397e37 65162-302 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Amneal Pharmaceuticals, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65162-305_db45897b-3d2a-4902-8383-de8de5397e37 65162-305 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Amneal Pharmaceuticals, LLC VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65162-306_db45897b-3d2a-4902-8383-de8de5397e37 65162-306 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Amneal Pharmaceuticals, LLC VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65162-307_db45897b-3d2a-4902-8383-de8de5397e37 65162-307 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine TABLET ORAL 20100511 ANDA ANDA079098 Amneal Pharmaceuticals, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65162-316_01848b0d-f353-4512-8013-b3af3921a6f6 65162-316 HUMAN PRESCRIPTION DRUG Lomedia 24 Fe Norethindrone Acetate and Ethinyl Estradiol KIT ORAL 20131220 ANDA ANDA078267 Amneal Pharmaceuticals of New York, LLC N 20181231 65162-321_85fbff80-ce1d-4424-8dac-c89af61a8a84 65162-321 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20150727 ANDA ANDA203578 Amneal Pharmaceuticals of New York, LLC NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 65162-322_57ae16f9-8cd6-4b18-a345-228abac8b6e0 65162-322 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151211 ANDA ANDA204178 Amneal Pharmaceuticals of New York, LLC NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 65162-323_85fbff80-ce1d-4424-8dac-c89af61a8a84 65162-323 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20150727 ANDA ANDA203578 Amneal Pharmaceuticals of New York, LLC NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 65162-347_83f380c0-a952-4540-bd78-18a44778768f 65162-347 HUMAN PRESCRIPTION DRUG Zenchent FE Norethindrone and Ethinyl Estradiol KIT 20110926 ANDA ANDA078892 Amneal Pharmaceuticals of New York, LLC N 20181231 65162-351_0fd265a2-f0eb-4e7f-9274-730b1f18875c 65162-351 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET ORAL 20121108 ANDA ANDA202025 Amneal Pharmaceuticals LLC SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 65162-356_bff016c0-424c-4fef-b2de-01412562470b 65162-356 HUMAN OTC DRUG Ibuprofen Pain Reliever/Fever Reducer Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130329 ANDA ANDA202300 Amneal Pharmaceuticals IBUPROFEN 200 mg/1 N 20181231 65162-361_81c80ae0-24bd-449b-a578-aecd3c09cdf9 65162-361 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20091202 ANDA ANDA040625 Amneal Pharmaceuticals of New York, LLC FOLIC ACID 1 mg/1 N 20181231 65162-371_1b4989b6-bfc5-4802-87b3-d3c4e91bc415 65162-371 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20151102 ANDA ANDA204010 Amneal Pharmaceuticals LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 65162-372_1b4989b6-bfc5-4802-87b3-d3c4e91bc415 65162-372 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20151102 ANDA ANDA204010 Amneal Pharmaceuticals LLC OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 65162-373_1b4989b6-bfc5-4802-87b3-d3c4e91bc415 65162-373 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20151102 ANDA ANDA204010 Amneal Pharmaceuticals LLC OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 65162-414_f138d1db-c5ca-4292-b27b-8e4b0c98dab6 65162-414 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET ORAL 20130930 ANDA ANDA203751 Amneal Pharmaceuticals of New York, LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 65162-415_e84235e8-7ee1-475e-9d23-22ad122f6b0b 65162-415 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 Amneal Pharmaceuticals LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 8; 2 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 65162-416_e84235e8-7ee1-475e-9d23-22ad122f6b0b 65162-416 HUMAN PRESCRIPTION DRUG Buprenorphine HCl and Naloxone HCl Buprenorphine and Naloxone TABLET SUBLINGUAL 20130222 ANDA ANDA203136 Amneal Pharmaceuticals LLC BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] CIII N 20181231 65162-436_05309201-abbd-4e9f-8509-dd12b978d5c6 65162-436 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20161201 ANDA ANDA203995 Amneal Pharmaceuticals, LLC DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 65162-438_05309201-abbd-4e9f-8509-dd12b978d5c6 65162-438 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20161201 ANDA ANDA203995 Amneal Pharmaceuticals, LLC DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 65162-441_2930f4a0-a52d-44dd-9c8e-1d1426f598de 65162-441 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine TABLET ORAL 20100212 ANDA ANDA201451 Amneal Pharmaceuticals LLC MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 65162-442_2930f4a0-a52d-44dd-9c8e-1d1426f598de 65162-442 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20100212 ANDA ANDA201451 Amneal Pharmaceuticals LLC MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 65162-444_2930f4a0-a52d-44dd-9c8e-1d1426f598de 65162-444 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20100212 ANDA ANDA201451 Amneal Pharmaceuticals LLC MECLIZINE HYDROCHLORIDE 50 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 65162-446_e6312a70-ec3f-44ac-827c-74ea957cc407 65162-446 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20141128 ANDA ANDA206652 Amneal Pharmaceuticals LLC ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65162-449_e6312a70-ec3f-44ac-827c-74ea957cc407 65162-449 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20141128 ANDA ANDA206652 Amneal Pharmaceuticals LLC ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65162-464_4a7c4731-cf1c-4830-bd28-3de55810313a 65162-464 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Amneal Pharmaceuticals LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 65162-465_4a7c4731-cf1c-4830-bd28-3de55810313a 65162-465 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Amneal Pharmaceuticals LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 65162-466_4a7c4731-cf1c-4830-bd28-3de55810313a 65162-466 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Amneal Pharmaceuticals LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 65162-468_0bb3104d-ddc8-462e-a094-fd918ee49b7f 65162-468 HUMAN PRESCRIPTION DRUG Clindamycin Palmitate Hydrochloride (Pediatric) Clindamycin Palmitate Hydrochloride POWDER, FOR SOLUTION ORAL 20130902 ANDA ANDA203513 Amneal Pharmaceuticals LLC CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 65162-475_c596022a-452a-4bfd-be9f-34ae3ea74f70 65162-475 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone TABLET ORAL 20090701 ANDA ANDA200275 Amneal Pharmaceuticals of New York, LLC NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 65162-478_9a19388a-3a10-4660-a4a6-63c4bcc89105 65162-478 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin monohydrate/macrocrystals CAPSULE ORAL 20170525 ANDA ANDA207372 Amneal Pharmaceuticals LLC NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 65162-506_41582800-c55d-4a09-befb-eca639d35161 65162-506 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20101206 ANDA ANDA091549 Amneal Pharmaceuticals LLC INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65162-511_ca1c09a4-ec05-4ebe-9c38-5ab8d5b4313f 65162-511 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Amneal Pharmaceuticals of New York, LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 65162-512_4a04f49c-cb8d-4e5b-82f5-2cbe41d17cba 65162-512 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals LLC SALSALATE 500 mg/1 N 20181231 65162-513_4a04f49c-cb8d-4e5b-82f5-2cbe41d17cba 65162-513 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals LLC SALSALATE 750 mg/1 N 20181231 65162-514_ca1c09a4-ec05-4ebe-9c38-5ab8d5b4313f 65162-514 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Amneal Pharmaceuticals of New York, LLC SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 65162-515_ca1c09a4-ec05-4ebe-9c38-5ab8d5b4313f 65162-515 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Amneal Pharmaceuticals of New York, LLC SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 65162-517_0e3eb561-2965-44a6-a059-160f1607806a 65162-517 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 65162-519_df127fee-bcb2-4124-8547-e2a95e55de47 65162-519 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE ORAL 20170618 ANDA ANDA203289 Amneal Pharmaceuticals LLC CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 65162-520_0e3eb561-2965-44a6-a059-160f1607806a 65162-520 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 65162-521_0e8b98e0-1b6c-4d44-846c-7d350777afbd 65162-521 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Amneal Pharmaceuticals, LLC PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 65162-522_0e8b98e0-1b6c-4d44-846c-7d350777afbd 65162-522 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Amneal Pharmaceuticals, LLC PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 65162-528_b1d60bb4-4909-4074-9fa1-e6768a368127 65162-528 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20130228 ANDA ANDA090767 Amneal Pharmaceuticals LLC LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65162-529_b1d60bb4-4909-4074-9fa1-e6768a368127 65162-529 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20130228 ANDA ANDA090767 Amneal Pharmaceuticals LLC LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65162-536_3af85b4f-8c6a-4e2a-b3c5-92f567d68b1b 65162-536 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Amneal Pharmaceuticals, LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 65162-537_3af85b4f-8c6a-4e2a-b3c5-92f567d68b1b 65162-537 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Amneal Pharmaceuticals, LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 65162-538_b1d60bb4-4909-4074-9fa1-e6768a368127 65162-538 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20130228 ANDA ANDA090767 Amneal Pharmaceuticals LLC LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65162-539_b1d60bb4-4909-4074-9fa1-e6768a368127 65162-539 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20130228 ANDA ANDA090767 Amneal Pharmaceuticals LLC LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65162-540_b1d1d29c-ada7-45c3-91fb-53a6e4d203d4 65162-540 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20100218 ANDA ANDA078218 Amneal Pharmaceuticals of New York, LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 65162-541_b1d1d29c-ada7-45c3-91fb-53a6e4d203d4 65162-541 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20100218 ANDA ANDA078218 Amneal Pharmaceuticals of New York, LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 65162-542_e58924cd-e819-4527-9101-d181aa4882f0 65162-542 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20130222 ANDA ANDA202128 Amneal Pharmaceuticals POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 65162-544_b0e60cb7-b1b0-49e2-b150-671d9bb48fe6 65162-544 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20091224 ANDA ANDA040866 Amneal Pharmaceuticals, LLC PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65162-545_b0e60cb7-b1b0-49e2-b150-671d9bb48fe6 65162-545 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20091224 ANDA ANDA040866 Amneal Pharmaceuticals, LLC PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65162-553_eccdf309-eb53-4f71-8ab0-a3cc97fb2f87 65162-553 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20130531 ANDA ANDA203399 Amneal Pharmaceuticals, LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 65162-554_66056f08-c422-43e2-bb83-d1a751b914c8 65162-554 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline TABLET ORAL 20080227 ANDA ANDA065425 Amneal Pharmaceuticals of New York, LLC DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 65162-555_66056f08-c422-43e2-bb83-d1a751b914c8 65162-555 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline TABLET ORAL 20080227 ANDA ANDA065425 Amneal Pharmaceuticals of New York, LLC DEMECLOCYCLINE HYDROCHLORIDE 300 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 65162-556_a663b954-5967-451a-aad3-6f8d74b405a7 65162-556 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20160523 ANDA ANDA203482 Amneal Pharmaceuticals LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65162-557_a663b954-5967-451a-aad3-6f8d74b405a7 65162-557 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20160523 ANDA ANDA203482 Amneal Pharmaceuticals LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65162-571_cdfa38c8-cd03-4454-bd08-0e986312d6b8 65162-571 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20071121 ANDA ANDA040855 Amneal Pharmaceuticals of New York, LLC BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 65162-572_cdfa38c8-cd03-4454-bd08-0e986312d6b8 65162-572 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20071121 ANDA ANDA040855 Amneal Pharmaceuticals of New York, LLC BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 65162-573_cdfa38c8-cd03-4454-bd08-0e986312d6b8 65162-573 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20071121 ANDA ANDA040855 Amneal Pharmaceuticals of New York, LLC BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 65162-574_cdfa38c8-cd03-4454-bd08-0e986312d6b8 65162-574 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20071121 ANDA ANDA040855 Amneal Pharmaceuticals of New York, LLC BETHANECHOL CHLORIDE 50 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 65162-576_df127fee-bcb2-4124-8547-e2a95e55de47 65162-576 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE ORAL 20170618 ANDA ANDA203289 Amneal Pharmaceuticals LLC CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 65162-583_a663b954-5967-451a-aad3-6f8d74b405a7 65162-583 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20160523 ANDA ANDA203482 Amneal Pharmaceuticals LLC TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65162-584_a663b954-5967-451a-aad3-6f8d74b405a7 65162-584 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20160523 ANDA ANDA203482 Amneal Pharmaceuticals LLC TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65162-590_ce93b944-2787-430b-9078-a63465846fd0 65162-590 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20141008 ANDA ANDA201658 Amneal Pharmaceuticals LLC CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 65162-596_d98f652c-6e55-4ad8-8e4d-eaf40d47c3c6 65162-596 HUMAN PRESCRIPTION DRUG Aspirin and Extended-Release Dipyridamole Aspirin and Extended-Release Dipyridamole CAPSULE ORAL 20160328 ANDA ANDA206392 Amneal Pharmaceuticals LLC ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 65162-617_4d186a04-1fb2-485d-a367-26192364a812 65162-617 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Amneal Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 65162-627_b14813e5-860d-4dfe-848e-32670205d652 65162-627 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 Amneal Pharmaceuticals LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 65162-630_56cb617a-13ac-495f-a276-abb6c12f90a7 65162-630 HUMAN PRESCRIPTION DRUG Itraconazole Itraconazole CAPSULE ORAL 20160927 ANDA ANDA205080 Amneal Pharmaceuticals LLC ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 65162-636_c972e2db-a134-41dc-ad75-ca400622d9f4 65162-636 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole TABLET, DELAYED RELEASE ORAL 20160620 ANDA ANDA205119 Amneal Pharmaceuticals LLC PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 65162-637_c972e2db-a134-41dc-ad75-ca400622d9f4 65162-637 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole TABLET, DELAYED RELEASE ORAL 20160620 ANDA ANDA205119 Amneal Pharmaceuticals LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 65162-641_2dff8bae-92c3-4f14-bbbb-52456571730d 65162-641 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20091201 ANDA ANDA075442 Amneal Pharmaceuticals LLC FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] N 20181231 65162-642_2dff8bae-92c3-4f14-bbbb-52456571730d 65162-642 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20091201 ANDA ANDA075442 Amneal Pharmaceuticals LLC FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 65162-643_2dff8bae-92c3-4f14-bbbb-52456571730d 65162-643 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20091201 ANDA ANDA075442 Amneal Pharmaceuticals LLC FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 65162-649_8e66c0db-18ac-4798-a609-595840d6dbf5 65162-649 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine SUSPENSION ORAL 20120604 ANDA ANDA202961 Amneal Pharmaceuticals LLC OXCARBAZEPINE 300 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65162-659_9471ae67-9d2c-4130-88ae-ef2092b39efd 65162-659 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine SOLUTION ORAL 20091214 ANDA ANDA090576 Amneal Pharmaceuticals LLC NIZATIDINE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 65162-664_8730ce81-4c53-490a-b1bf-6148e401039d 65162-664 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine SOLUTION ORAL 20100312 ANDA ANDA078312 Amneal Pharmaceuticals LLC RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 65162-667_1c8c8f7a-b79d-4938-a653-3daf3db8bf82 65162-667 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20091201 ANDA ANDA078345 Amneal Pharmaceuticals of New York, LLC PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 65162-668_3a2826b9-7c80-4f0c-b154-bc02ec55b658 65162-668 HUMAN PRESCRIPTION DRUG PRENATAL PLUS VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE TABLET, FILM COATED ORAL 20091202 UNAPPROVED DRUG OTHER Amneal Pharmaceuticals, LLC VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE 3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 65162-669_df6a6016-eea4-40de-9086-04bedb3c2074 65162-669 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091201 ANDA ANDA075047 Amneal Pharmaceuticals of New York, LLC ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65162-670_df6a6016-eea4-40de-9086-04bedb3c2074 65162-670 HUMAN PRESCRIPTION DRUG Acebutolol Hydrochloride Acebutolol Hydrochloride CAPSULE ORAL 20091201 ANDA ANDA075047 Amneal Pharmaceuticals of New York, LLC ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65162-672_010ab916-bc42-4e69-85d6-6585fc34226d 65162-672 HUMAN OTC DRUG Ibuprofen Pain Reliever/ Fever Reducer Ibuprofen SUSPENSION ORAL 20111112 ANDA ANDA200457 Amneal Pharmaceuticals IBUPROFEN 100 mg/5mL N 20181231 65162-673_59fec1fa-e523-4d77-b94c-13e8fb2ae141 65162-673 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20110531 ANDA ANDA091384 Amneal Pharmaceuticals LLC RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 65162-675_df04c921-3fc4-49ba-a382-5e852a116d9d 65162-675 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20150130 ANDA ANDA206869 Amneal Pharmaceuticals LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 65162-676_f95450fe-7803-49d7-b2f1-bfb0285674cf 65162-676 HUMAN PRESCRIPTION DRUG Azelastine Hydrochloride Azelastine SPRAY, METERED NASAL 20170905 ANDA ANDA204660 Amneal Pharmaceuticals LLC AZELASTINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 65162-678_540907e5-8522-4b69-9afc-5aab1c1e186b 65162-678 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine SOLUTION ORAL 20091230 ANDA ANDA040882 Amneal Pharmaceuticals of New York, LLC PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 65162-679_ba12e57c-803a-477f-974f-5b0700368fa6 65162-679 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Phenylephrine Hydrochloride Promethazine and Phenylephrine SOLUTION ORAL 20090825 ANDA ANDA040902 Amneal Pharmaceuticals of New York, LLC PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 5 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] N 20181231 65162-680_9fdb590d-9632-4db0-a1c7-f4ffb22dfc70 65162-680 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextomethorphan Hydrobromide Promethazine Hydrochloride and Dextomethorphan Hydrobromide SOLUTION ORAL 20100331 ANDA ANDA090575 Amneal Pharmaceuticals PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 6.25; 15 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] E 20171231 65162-684_0b578b16-f4ee-4be4-b049-5f6f1140aba4 65162-684 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine SOLUTION ORAL 20091007 ANDA ANDA090766 Amneal Pharmaceuticals LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 65162-685_ac945d74-cce4-4140-b37a-83c9cc09a25b 65162-685 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20091027 ANDA ANDA090992 Amneal Pharmaceuticals LLC LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65162-686_337a0849-dfad-41df-9352-b44a610e24b1 65162-686 HUMAN PRESCRIPTION DRUG Felbamate Felbamate SUSPENSION ORAL 20111216 ANDA ANDA202385 Amneal Pharmaceuticals LLC FELBAMATE 600 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65162-687_2d562087-8da3-432a-bd1b-9726ea6c7098 65162-687 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam CONCENTRATE ORAL 20100201 ANDA ANDA091383 Amneal Pharmaceuticals, LLC LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65162-689_75f4b320-282c-46a8-9ecc-055de2b08cdf 65162-689 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantoin SUSPENSION ORAL 20110324 ANDA ANDA201679 Amneal Pharmaceuticals LLC NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 65162-691_7cf1c1a1-0720-4cd1-aa7e-4904ac0c5320 65162-691 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron SOLUTION ORAL 20101217 ANDA ANDA091483 Amneal Pharmaceuticals of New York, LLC ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 65162-693_7d24a3b4-d36a-4a57-bb17-64d825888ff2 65162-693 HUMAN PRESCRIPTION DRUG ATOVAQUONE ATOVAQUONE SUSPENSION ORAL 20110209 ANDA ANDA202960 Amneal Pharmaceuticals LLC ATOVAQUONE 750 mg/5mL Antimalarial [EPC],Antiprotozoal [EPC] N 20181231 65162-694_f2889215-3c6b-437c-98a5-78f65894b0f6 65162-694 HUMAN PRESCRIPTION DRUG Promethazine HCl, Phenylephrine HCl, Codeine Phosphate Promethazine, Phenylephrine, Codeine SYRUP ORAL 20131101 ANDA ANDA200963 Amneal Pharmaceuticals LLC PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 5; 10 mg/5mL; mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 65162-695_224f33cc-b134-4ab6-ba64-fc404d2bc54d 65162-695 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Codeine Phosphate Promethazine and Codeine SYRUP ORAL 20130315 ANDA ANDA200894 Amneal Pharmaceuticals LLC PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 65162-696_98eeda1f-a1fb-43fa-8f52-1560b07837ea 65162-696 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20150227 ANDA ANDA207137 Amneal Pharmaceuticals, LLC HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 300 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 65162-698_ebda3c6b-4d2e-4da2-8ef9-0ce63dd0bc8e 65162-698 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin SOLUTION ORAL 20110930 ANDA ANDA202024 Amneal Pharmaceuticals LLC GABAPENTIN 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65162-700_ca6f0629-dff9-4d9d-9ab0-469f339397b0 65162-700 HUMAN OTC DRUG Dextromethorphan Polistirex Extended-Release Dextromethorphan Polistirex SUSPENSION ORAL 20170801 ANDA ANDA203133 Amneal Pharmaceuticals LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 65162-702_79cc0041-81c7-4ab2-afe2-398ebf60bf51 65162-702 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL AURICULAR (OTIC) 20150922 ANDA ANDA091306 Amneal Pharmaceuticals, LLC FLUOCINOLONE ACETONIDE .11 mg/20mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 65162-703_32207a82-3cdb-4e3d-8b3d-dc0b2fe2aded 65162-703 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20150922 ANDA ANDA201759 Amneal Pharmaceuticals, LLC FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 65162-704_df21fdb6-2f57-42ba-aad5-957ee774e789 65162-704 HUMAN PRESCRIPTION DRUG Fluocinolone Acetonide Fluocinolone Acetonide OIL TOPICAL 20150922 ANDA ANDA201764 Amneal Pharmaceuticals, LLC FLUOCINOLONE ACETONIDE .11 mg/118.28mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 65162-705_63f7925c-9952-482d-a9a0-e647abac0ed0 65162-705 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram SOLUTION ORAL 20110903 ANDA ANDA202227 Amneal Pharmaceuticals LLC ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65162-710_0d265fb7-da26-40c6-bb50-c1211e13403a 65162-710 HUMAN PRESCRIPTION DRUG Colchicine Colchicine TABLET ORAL 20160930 ANDA ANDA204711 Amneal Pharmaceuticals of New York, LLC COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20181231 65162-711_8bf9b7ba-4c15-44cc-a69f-21c38c37fb8d 65162-711 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine TABLET ORAL 19981125 ANDA ANDA075109 Amneal Pharmaceuticals LLC GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 65162-713_8bf9b7ba-4c15-44cc-a69f-21c38c37fb8d 65162-713 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine TABLET ORAL 19981125 ANDA ANDA075109 Amneal Pharmaceuticals LLC GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 65162-724_b1371deb-647a-4a70-b2bf-43b7af8ff2f6 65162-724 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole TABLET, DELAYED RELEASE ORAL 20151001 ANDA ANDA204179 Amneal Pharmaceuticals LLC RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 65162-732_a24b3a13-172f-464b-a268-362e3ee8c576 65162-732 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast TABLET ORAL 20130731 ANDA ANDA204604 Amneal Pharmaceuticals LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 65162-734_c5c6c56b-7c33-41c3-a0fb-b4f5efec8cab 65162-734 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20110916 ANDA ANDA201680 Amneal Pharmaceuticals LLC FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65162-735_c5c6c56b-7c33-41c3-a0fb-b4f5efec8cab 65162-735 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20110916 ANDA ANDA201680 Amneal Pharmaceuticals LLC FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65162-745_0e8b98e0-1b6c-4d44-846c-7d350777afbd 65162-745 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Amneal Pharmaceuticals, LLC PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 65162-750_4d8621ad-55b5-4db4-94f4-a8f0c4e8eeff 65162-750 HUMAN PRESCRIPTION DRUG Dutasteride Dutasteride CAPSULE ORAL 20151102 ANDA ANDA203118 Amneal Pharmaceuticals of New York, LLC DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 65162-751_98eba605-2e62-4eab-81b5-d19bc5b0d499 65162-751 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Amneal Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65162-752_98eba605-2e62-4eab-81b5-d19bc5b0d499 65162-752 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Amneal Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65162-753_98eba605-2e62-4eab-81b5-d19bc5b0d499 65162-753 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Amneal Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65162-754_98eba605-2e62-4eab-81b5-d19bc5b0d499 65162-754 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 Amneal Pharmaceuticals LLC BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65162-755_6d74d452-0fe7-4816-bf1f-aa79dc7c9f4c 65162-755 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20150601 ANDA ANDA203730 Amneal Pharmaceuticals LLC DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65162-757_6d74d452-0fe7-4816-bf1f-aa79dc7c9f4c 65162-757 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20150601 ANDA ANDA203730 Amneal Pharmaceuticals LLC DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65162-761_1096c48f-e6f5-46cc-bc33-2d5a13059c4a 65162-761 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals LLC WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65162-762_1096c48f-e6f5-46cc-bc33-2d5a13059c4a 65162-762 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65162-763_1096c48f-e6f5-46cc-bc33-2d5a13059c4a 65162-763 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals LLC WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65162-764_1096c48f-e6f5-46cc-bc33-2d5a13059c4a 65162-764 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals LLC WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65162-765_1096c48f-e6f5-46cc-bc33-2d5a13059c4a 65162-765 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals LLC WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65162-766_1096c48f-e6f5-46cc-bc33-2d5a13059c4a 65162-766 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals LLC WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65162-767_1096c48f-e6f5-46cc-bc33-2d5a13059c4a 65162-767 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals LLC WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65162-768_1096c48f-e6f5-46cc-bc33-2d5a13059c4a 65162-768 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals LLC WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65162-769_1096c48f-e6f5-46cc-bc33-2d5a13059c4a 65162-769 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20100816 ANDA ANDA202202 Amneal Pharmaceuticals LLC WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65162-770_ecc1be1d-f4f2-41e6-b6c0-860e0e82a8d0 65162-770 HUMAN OTC DRUG Ibuprofen Pain Reliever/Fever Reducer Ibuprofen CAPSULE, LIQUID FILLED ORAL 20111223 ANDA ANDA202300 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 200 mg/1 N 20181231 65162-777_bed88b2b-ecfa-4db4-b258-2b0f29320984 65162-777 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET ORAL 20150519 ANDA ANDA204536 Amneal Pharmaceuticals LLC LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 65162-778_11ab6fa5-2526-44fc-b02f-72ec038adbfe 65162-778 HUMAN PRESCRIPTION DRUG Budesonide Budesonide CAPSULE, GELATIN COATED ORAL 20170915 ANDA ANDA206200 Amneal Pharmaceuticals LLC BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 65162-782_75a861f8-bf73-465d-9043-9c90eb5d1176 65162-782 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171222 ANDA ANDA205825 Amneal Pharmaceuticals LLC MEMANTINE HYDROCHLORIDE 7 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 65162-783_75a861f8-bf73-465d-9043-9c90eb5d1176 65162-783 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171222 ANDA ANDA205825 Amneal Pharmaceuticals LLC MEMANTINE HYDROCHLORIDE 14 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 65162-784_75a861f8-bf73-465d-9043-9c90eb5d1176 65162-784 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171222 ANDA ANDA205825 Amneal Pharmaceuticals LLC MEMANTINE HYDROCHLORIDE 21 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 65162-785_75a861f8-bf73-465d-9043-9c90eb5d1176 65162-785 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171222 ANDA ANDA205825 Amneal Pharmaceuticals LLC MEMANTINE HYDROCHLORIDE 28 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 65162-799_87639fb1-4ece-4aab-b308-13d0dff43e17 65162-799 HUMAN OTC DRUG Dextromethorphan Polistirex Extended-Release Dextromethorphan Polistirex SUSPENSION ORAL 20170801 ANDA ANDA203133 Amneal Pharmaceuticals LLC DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 65162-801_0ee2b738-ebee-4566-911d-b63e5d17b33d 65162-801 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20150403 ANDA ANDA203691 Amneal Pharmaceuticals LLC TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 65162-802_0ee2b738-ebee-4566-911d-b63e5d17b33d 65162-802 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20150403 ANDA ANDA203691 Amneal Pharmaceuticals LLC TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 65162-803_0ee2b738-ebee-4566-911d-b63e5d17b33d 65162-803 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20150403 ANDA ANDA203691 Amneal Pharmaceuticals LLC TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 65162-804_0ee2b738-ebee-4566-911d-b63e5d17b33d 65162-804 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20150403 ANDA ANDA203691 Amneal Pharmaceuticals LLC TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 65162-805_0ee2b738-ebee-4566-911d-b63e5d17b33d 65162-805 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20150403 ANDA ANDA203691 Amneal Pharmaceuticals LLC TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 65162-806_0ee2b738-ebee-4566-911d-b63e5d17b33d 65162-806 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20150403 ANDA ANDA203691 Amneal Pharmaceuticals LLC TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 65162-807_9c0a0c6d-ab33-475c-a4b8-f0af97a0a40e 65162-807 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20170911 ANDA ANDA207724 Amneal Pharmaceuticals LLC PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 65162-808_9c0a0c6d-ab33-475c-a4b8-f0af97a0a40e 65162-808 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20170911 ANDA ANDA207724 Amneal Pharmaceuticals LLC PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 65162-809_d454635a-c186-46cb-b673-fd10b2d08165 65162-809 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Amneal Pharmaceuticals, LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65162-810_d454635a-c186-46cb-b673-fd10b2d08165 65162-810 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Amneal Pharmaceuticals, LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65162-811_08500ecb-d8ef-48f7-b409-8fca0af68edd 65162-811 HUMAN PRESCRIPTION DRUG Quinine Sulfate Quinine CAPSULE ORAL 20160729 ANDA ANDA203729 Amneal Pharmaceuticals of New York, LLC QUININE SULFATE 324 mg/1 Antimalarial [EPC] N 20181231 65162-812_d454635a-c186-46cb-b673-fd10b2d08165 65162-812 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Amneal Pharmaceuticals, LLC ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65162-813_d454635a-c186-46cb-b673-fd10b2d08165 65162-813 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20091203 ANDA ANDA078387 Amneal Pharmaceuticals, LLC ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65162-822_010159ce-0993-45c7-a15a-ae8d7996737f 65162-822 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE ORAL 20160115 ANDA ANDA204327 Amneal Pharmaceuticals LLC PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 65162-823_010159ce-0993-45c7-a15a-ae8d7996737f 65162-823 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE ORAL 20160115 ANDA ANDA204327 Amneal Pharmaceuticals LLC PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 65162-824_010159ce-0993-45c7-a15a-ae8d7996737f 65162-824 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE ORAL 20160115 ANDA ANDA204327 Amneal Pharmaceuticals LLC PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 65162-833_6e6a751c-eba1-4af7-8cf3-ad6686f3a1ff 65162-833 HUMAN PRESCRIPTION DRUG Diclofenac sodium Diclofenac GEL TOPICAL 20160321 ANDA ANDA208077 Amneal Pharmaceuticals LLC DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65162-835_c09c2505-412f-477e-9eff-de01198ca452 65162-835 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir OINTMENT TOPICAL 20140103 ANDA ANDA204605 Amneal Pharmaceuticals of New York, LLC ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 65162-837_70e24781-5e47-479a-9d9d-e3e1a716c1e6 65162-837 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20160127 ANDA ANDA204011 Amneal Pharmaceuticals LLC VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65162-838_70e24781-5e47-479a-9d9d-e3e1a716c1e6 65162-838 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20160127 ANDA ANDA204011 Amneal Pharmaceuticals LLC VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65162-839_70e24781-5e47-479a-9d9d-e3e1a716c1e6 65162-839 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20160127 ANDA ANDA204011 Amneal Pharmaceuticals LLC VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65162-840_70e24781-5e47-479a-9d9d-e3e1a716c1e6 65162-840 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20160127 ANDA ANDA204011 Amneal Pharmaceuticals LLC VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65162-843_4d4304bb-9290-4ce2-be78-ed0f66ed2d52 65162-843 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET ORAL 20170310 ANDA ANDA204741 Amneal Pharmaceuticals LLC CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 65162-844_4d4304bb-9290-4ce2-be78-ed0f66ed2d52 65162-844 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET ORAL 20170310 ANDA ANDA204741 Amneal Pharmaceuticals LLC CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 65162-891_59da8c05-8929-48bf-a50a-626fc775ceee 65162-891 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone SPRAY, METERED NASAL 20170404 ANDA ANDA207989 Amneal Pharmaceuticals LLC MOMETASONE FUROATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 65162-893_d69ff72d-c553-476e-9126-be0450241cf9 65162-893 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole SOLUTION ORAL 20150817 ANDA ANDA203906 Amneal Pharmaceuticals LLC ARIPIPRAZOLE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 65162-896_c6b7fce8-3607-4516-8eb2-97933076a31a 65162-896 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160620 ANDA ANDA204838 Amneal Pharmaceuticals LLC ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 65162-897_c6b7fce8-3607-4516-8eb2-97933076a31a 65162-897 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160620 ANDA ANDA204838 Amneal Pharmaceuticals LLC ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 65162-898_c6b7fce8-3607-4516-8eb2-97933076a31a 65162-898 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160620 ANDA ANDA204838 Amneal Pharmaceuticals LLC ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 65162-899_c6b7fce8-3607-4516-8eb2-97933076a31a 65162-899 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160620 ANDA ANDA204838 Amneal Pharmaceuticals LLC ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 65162-901_c6b7fce8-3607-4516-8eb2-97933076a31a 65162-901 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160620 ANDA ANDA204838 Amneal Pharmaceuticals LLC ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 65162-902_c6b7fce8-3607-4516-8eb2-97933076a31a 65162-902 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160620 ANDA ANDA204838 Amneal Pharmaceuticals LLC ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 65162-911_ed6b3c09-4364-4f20-871b-d62b1ab69548 65162-911 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac SOLUTION TOPICAL 20160902 ANDA ANDA206116 Amneal Pharmaceuticals LLC DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65162-912_32fb4b27-d0ee-4fb9-9f4f-f3845999d299 65162-912 HUMAN PRESCRIPTION DRUG Lacosamide Lacosamide SOLUTION ORAL 20131129 ANDA ANDA204839 Amneal Pharmaceuticals of New York, LLC LACOSAMIDE 10 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 65162-913_907a35cb-6c66-4cdc-a90b-c76e1f567e33 65162-913 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole POWDER, FOR SUSPENSION ORAL 20131129 ANDA ANDA205034 Amneal Pharmaceuticals LLC VORICONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 65162-914_36d1a7c2-1d4c-4f3a-91f9-ff722899d572 65162-914 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION RESPIRATORY (INHALATION) 20140713 ANDA ANDA205501 Amneal Pharmaceuticals LLC TOBRAMYCIN 300 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 65162-918_72c27a2b-dfd1-4a6c-9ff1-b78f284816da 65162-918 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20150810 ANDA ANDA206297 Amneal Pharmaceuticals LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 65162-918_d705e48f-2bb2-427a-aa2f-4fe028b8d785 65162-918 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20150810 ANDA ANDA206297 Amneal Pharmaceuticals LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 65162-955_da4c5225-1b4c-4440-b656-6750f8b349c6 65162-955 HUMAN PRESCRIPTION DRUG Esomeprazole strontium Esomeprazole strontium CAPSULE, DELAYED RELEASE ORAL 20130812 NDA NDA202342 Amneal Pharmaceuticals of New York, LLC ESOMEPRAZOLE STRONTIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65162-957_da4c5225-1b4c-4440-b656-6750f8b349c6 65162-957 HUMAN PRESCRIPTION DRUG Esomeprazole strontium Esomeprazole strontium CAPSULE, DELAYED RELEASE ORAL 20130812 NDA NDA202342 Amneal Pharmaceuticals of New York, LLC ESOMEPRAZOLE STRONTIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65162-998_eac1e97f-2b95-48a9-b37f-5bfcd5b70972 65162-998 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20130517 ANDA ANDA078476 Amneal Pharmaceuticals of New York, LLC FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 65162-999_eac1e97f-2b95-48a9-b37f-5bfcd5b70972 65162-999 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin Sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 20130517 ANDA ANDA078476 Amneal Pharmaceuticals of New York, LLC FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 65174-021_095d75a5-4614-46a2-b180-bc43e3de0f34 65174-021 HUMAN PRESCRIPTION DRUG RUBY-FILL Rubidium Rb 82 INJECTION, SOLUTION INTRAVENOUS 20160930 NDA NDA202153 Jubilant DraxImage Inc. RUBIDIUM CHLORIDE RB-82 100 mCi/1 Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 65174-200_868165af-d557-453e-8ed4-9cf67e4e7464 65174-200 HUMAN PRESCRIPTION DRUG Drax Exametazime Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte Labeling INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170817 NDA NDA208870 Jubilant DraxImage Inc. TECHNETIUM TC-99M EXAMETAZIME .5 mg/1 Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 65174-270_667a78b1-f330-4c13-baf7-0d53205c5a5f 65174-270 HUMAN PRESCRIPTION DRUG DRAXIMAGE MAA Kit for the Preparation of Technetium Tc 99m Albumin Aggregated INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19871230 NDA NDA017881 Jubilant DraxImage Inc. ALBUMIN AGGREGATED 2.5 mg/1 N 20181231 65174-288_a6d7b16e-f41f-4d24-817c-5574915dfbf8 65174-288 HUMAN PRESCRIPTION DRUG DRAXIMAGE DTPA Kit for the preparation of Technetium Tc 99m Pentetate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; RESPIRATORY (INHALATION) 19891229 NDA NDA018511 Jubilant DraxImage Inc. PENTETIC ACID 20 mg/1 Lead Chelating Activity [MoA],Lead Chelator [EPC] N 20191231 65174-461_bf805c70-0520-429f-a15c-157653f47022 65174-461 HUMAN PRESCRIPTION DRUG Sodium Iodide I 131 Diagnostic Sodium Iodide I 131 CAPSULE ORAL 20060501 NDA NDA021305 Jubilant DraxImage Inc. SODIUM IODIDE I-131 100 mCi/1 Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 65174-660_70497879-c320-e6ac-a1a7-5b1e7f104c3b 65174-660 HUMAN PRESCRIPTION DRUG Technetium Tc 99m Medronate Technetium Tc 99m Medronate INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20040227 NDA NDA018035 Jubilant DraxImage Inc MEDRONIC ACID 25 mg/1 N 20181231 65174-880_a3c600a0-7411-476d-a486-4153ff25420d 65174-880 HUMAN PRESCRIPTION DRUG HICON Sodium Iodide I 131 SOLUTION ORAL 20030407 NDA NDA021305 Jubilant DraxImage Inc. SODIUM IODIDE I-131 1 mCi/mL Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 65177-290_ad8a156e-31ef-484a-9967-73e0251a3bf8 65177-290 HUMAN OTC DRUG Hanson Daily Moisturizer SPF30 Octisalate, Homosalate, Avobenzone, Octocrylene LOTION TOPICAL 20151010 OTC MONOGRAPH FINAL part352 Hanson Medical, Inc OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE 5; 5; 3; 2.7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 65179-500_bcbc8163-dcf7-458f-a470-1e1a2edf2cc7 65179-500 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20161201 ANDA ANDA204272 GROUPE PARIMA INC DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 65179-501_868301cd-0b3c-466d-a1ad-f423ef2fd9e9 65179-501 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone GEL TOPICAL 20160812 ANDA ANDA204675 GROUPE PARIMA INC DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 65193-144_a7794f9e-1dd2-438e-bf10-47114b7fab5a 65193-144 HUMAN OTC DRUG Ephed Plus Sinus Acetaminophen, Pseudoephedrine HCl TABLET ORAL 20111018 OTC MONOGRAPH FINAL part341 Dickey Consumer Products DBA DMD ACETAMINOPHEN; PSEUDOEPHEDRINE HYDROCHLORIDE 325; 30 mg/1; mg/1 N 20181231 65193-180_5783da20-4fc7-4a7f-8c39-e3ffbf08e589 65193-180 HUMAN OTC DRUG Ephed Plus Liquid Ephedrine Guaifenesin LIQUID ORAL 20171110 OTC MONOGRAPH FINAL part341 Dickey Consumer Products DBA DMD EPHEDRINE HYDROCHLORIDE; GUAIFENESIN 25; 400 mg/60mL; mg/60mL N 20181231 65193-320_719d5a47-9b03-4ec0-91cb-404db1d2dee8 65193-320 HUMAN OTC DRUG Ephed Asthma ephedrine hydrochloride, guaifenesin TABLET ORAL 20111213 OTC MONOGRAPH FINAL part341 Dickey Consumer Products DBA DMD EPHEDRINE HYDROCHLORIDE; GUAIFENESIN 25; 200 mg/1; mg/1 N 20181231 65193-939_fd5ccac9-a54a-4284-80c8-a5f035c5d9e6 65193-939 HUMAN OTC DRUG Ephed 60 Pseudoephedrine LIQUID ORAL 20111010 OTC MONOGRAPH FINAL part341 Dickey Consumer Products DBA DMD PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/60mL N 20181231 65197-002_96d12576-d968-41bc-ad64-fd3812e09f25 65197-002 HUMAN PRESCRIPTION DRUG Dyrenium Triamterene CAPSULE ORAL 19991001 20191231 NDA NDA013174 WellSpring Pharmaceutical Corporation TRIAMTERENE 50 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] E 20171231 65197-003_96d12576-d968-41bc-ad64-fd3812e09f25 65197-003 HUMAN PRESCRIPTION DRUG Dyrenium Triamterene CAPSULE ORAL 19990101 20200131 NDA NDA013174 WellSpring Pharmaceutical Corporation TRIAMTERENE 100 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] E 20171231 65197-103_b361b33c-e062-4a75-b6b2-1d261bc3d5b5 65197-103 HUMAN OTC DRUG Micatin Miconazole nitrate CREAM TOPICAL 20090624 OTC MONOGRAPH FINAL part333C WellSpring Pharmaceutical Corporation MICONAZOLE NITRATE 20 mg/g N 20181231 65197-201_b5abbe96-76fe-4add-b04b-3a0e25ff581b 65197-201 HUMAN OTC DRUG Emetrol Cherry phosphorated carbohydrate SOLUTION ORAL 20090624 UNAPPROVED DRUG OTHER WellSpring Pharmaceutical Corporation DEXTROSE; PHOSPHORIC ACID; FRUCTOSE 1.87; 21.5; 1.87 g/5mL; mg/5mL; g/5mL N 20181231 65197-275_bf0743e3-837d-4554-8d76-d0ec8fd77e8a 65197-275 HUMAN OTC DRUG BONINE meclizine hydrochloride TABLET, CHEWABLE ORAL 20141215 OTC MONOGRAPH FINAL part336 WellSpring Pharmaceutical Corporation MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 65197-296_bf0743e3-837d-4554-8d76-d0ec8fd77e8a 65197-296 HUMAN OTC DRUG BONINE meclizine hydrochloride TABLET, CHEWABLE ORAL 20170418 OTC MONOGRAPH FINAL part336 WellSpring Pharmaceutical Corporation MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 65197-300_93e9b420-4a75-4c6a-b552-36747fbe7b96 65197-300 HUMAN OTC DRUG Gelusil Alumina, Magnesia, Simethicone TABLET, CHEWABLE ORAL 20080924 OTC MONOGRAPH FINAL part331 WellSpring Pharmaceutical Corporation ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE; SILICON DIOXIDE 200; 200; 24; 1 mg/1; mg/1; mg/1; mg/1 N 20181231 65197-426_2e5f5530-e694-446c-b5d8-1bed39e0b63a 65197-426 HUMAN OTC DRUG Barriere Dimethicone CREAM TOPICAL 20100802 OTC MONOGRAPH FINAL part347 WellSpring Pharmaceutical Corporation DIMETHICONE .2 g/g N 20181231 65197-810_ebeab166-a31a-4621-a3ee-e620e8a7d945 65197-810 HUMAN OTC DRUG Bactine Original First Aid BENZALKONIUM CHLORIDE and LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20151216 OTC MONOGRAPH NOT FINAL part333A WellSpring Pharmaceutical Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; 2.5 g/100mL; g/100mL N 20181231 65197-812_044e78ac-463f-4f5f-b263-6d545ce99a7a 65197-812 HUMAN OTC DRUG Bactine Pain Relieving BENZALKONIUM CHLORIDE and LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20151216 OTC MONOGRAPH NOT FINAL part333A WellSpring Pharmaceutical Corporation BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; 2.5 g/100mL; g/100mL N 20181231 65217-0001_f94ce6c6-ed91-422b-a408-65ec7d029c72 65217-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20081021 UNAPPROVED MEDICAL GAS Frances Mahon Deaconess Hospital Home Oxygen OXYGEN 99 L/100L E 20171231 65222-034_615377b0-5683-1ba2-e053-2991aa0a096c 65222-034 HUMAN PRESCRIPTION DRUG Nupro Fluorides Tropical Sodium Fluoride RINSE DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" SODIUM FLUORIDE 20 mg/g N 20181231 65222-036_615377b0-5683-1ba2-e053-2991aa0a096c 65222-036 HUMAN PRESCRIPTION DRUG Nupro Fluorides Mint Sodium Fluoride RINSE DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" SODIUM FLUORIDE 20 mg/g N 20181231 65222-038_615377b0-5683-1ba2-e053-2991aa0a096c 65222-038 HUMAN PRESCRIPTION DRUG Nupro Fluorides Berry Cherry Sodium Fluoride RINSE DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" SODIUM FLUORIDE 20 mg/g N 20181231 65222-040_615377b0-5683-1ba2-e053-2991aa0a096c 65222-040 HUMAN PRESCRIPTION DRUG Nupro Fluorides Peach Sodium Fluoride RINSE DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" SODIUM FLUORIDE 20 mg/g N 20181231 65222-110_60df53a6-8885-cdaa-e053-2a91aa0a15c3 65222-110 HUMAN PRESCRIPTION DRUG NUPRO 60 Second Fluoride Foam Sodium Fluoride AEROSOL, FOAM DENTAL 19970401 UNAPPROVED DRUG OTHER Dentsply Professional SODIUM FLUORIDE 27.3 mg/g N 20181231 65222-113_60df53a6-8885-cdaa-e053-2a91aa0a15c3 65222-113 HUMAN PRESCRIPTION DRUG NUPRO 60 Second Fluoride Foam Sodium Fluoride AEROSOL, FOAM DENTAL 19970401 UNAPPROVED DRUG OTHER Dentsply Professional SODIUM FLUORIDE 27.3 mg/g N 20181231 65222-114_60df53a6-8885-cdaa-e053-2a91aa0a15c3 65222-114 HUMAN PRESCRIPTION DRUG NUPRO 60 Second Fluoride Foam Sodium Fluoride AEROSOL, FOAM DENTAL 19970401 UNAPPROVED DRUG OTHER Dentsply Professional SODIUM FLUORIDE 27.3 mg/g N 20181231 65222-115_60df53a6-8885-cdaa-e053-2a91aa0a15c3 65222-115 HUMAN PRESCRIPTION DRUG NUPRO 60 Second Fluoride Foam Sodium Fluoride AEROSOL, FOAM DENTAL 19970401 UNAPPROVED DRUG OTHER Dentsply Professional SODIUM FLUORIDE 27.3 mg/g N 20181231 65222-401_6155acd9-8ec2-a87d-e053-2991aa0a7b43 65222-401 HUMAN PRESCRIPTION DRUG Nupro Fluorides NaF Oral Solution Mint Sodium Fluoride GEL DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" SODIUM FLUORIDE 20 mg/g N 20181231 65222-411_6155acd9-8ec2-a87d-e053-2991aa0a7b43 65222-411 HUMAN PRESCRIPTION DRUG Nupro Fluorides NaF Oral Solution Mandarin Orange Sodium Fluoride GEL DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" SODIUM FLUORIDE 20 mg/g N 20181231 65222-421_6155acd9-8ec2-a87d-e053-2991aa0a7b43 65222-421 HUMAN PRESCRIPTION DRUG Nupro Fluorides NaF Oral Solution Apple Cinnamon Sodium Fluoride GEL DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" SODIUM FLUORIDE 20 mg/g N 20181231 65222-431_6154542f-4ea5-7155-e053-2991aa0ad998 65222-431 HUMAN PRESCRIPTION DRUG Nupro Fluorides Wild Cherry Sodium Fluoride GEL DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" SODIUM FLUORIDE 25.9 mg/g N 20181231 65222-451_6154542f-4ea5-7155-e053-2991aa0ad998 65222-451 HUMAN PRESCRIPTION DRUG Nupro Fluorides Bubble Gum Sodium Fluoride GEL DENTAL 19000101 UNAPPROVED DRUG OTHER Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" SODIUM FLUORIDE 25.9 mg/g N 20181231 65222-720_b0f011a1-9917-46b8-826f-6c06c58bd5a4 65222-720 HUMAN PRESCRIPTION DRUG ORIS CHX Chlorhexidine Gluconate RINSE DENTAL 19990101 UNAPPROVED DRUG OTHER DENTSPLY Professional CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] E 20171231 65222-800_832ff188-c0c4-4922-b2b2-1a6de391bb42 65222-800 HUMAN PRESCRIPTION DRUG NUPRO Chlorhexidine Gluconate CHLORHEXIDINE GLUCONATE RINSE ORAL 20170117 ANDA ANDA077789 Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 65224-310_42f646ec-e8c8-4790-82bf-56363124667f 65224-310 HUMAN PRESCRIPTION DRUG ZOHYDRO ER Hydrocodone Bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Pernix Therapeutics HYDROCODONE BITARTRATE 10 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 65224-315_42f646ec-e8c8-4790-82bf-56363124667f 65224-315 HUMAN PRESCRIPTION DRUG ZOHYDRO ER Hydrocodone Bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Pernix Therapeutics HYDROCODONE BITARTRATE 15 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 65224-320_42f646ec-e8c8-4790-82bf-56363124667f 65224-320 HUMAN PRESCRIPTION DRUG ZOHYDRO ER Hydrocodone Bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Pernix Therapeutics HYDROCODONE BITARTRATE 20 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 65224-330_42f646ec-e8c8-4790-82bf-56363124667f 65224-330 HUMAN PRESCRIPTION DRUG ZOHYDRO ER Hydrocodone Bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Pernix Therapeutics HYDROCODONE BITARTRATE 30 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 65224-340_42f646ec-e8c8-4790-82bf-56363124667f 65224-340 HUMAN PRESCRIPTION DRUG ZOHYDRO ER Hydrocodone Bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Pernix Therapeutics HYDROCODONE BITARTRATE 40 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 65224-350_42f646ec-e8c8-4790-82bf-56363124667f 65224-350 HUMAN PRESCRIPTION DRUG ZOHYDRO ER Hydrocodone Bitartrate CAPSULE, EXTENDED RELEASE ORAL 20131025 NDA NDA202880 Pernix Therapeutics HYDROCODONE BITARTRATE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 65224-850_d653af2d-0d84-471c-b996-8cbd18b29ccc 65224-850 HUMAN PRESCRIPTION DRUG Treximet Sumatriptan Succinate and Naproxen Sodium TABLET, FILM COATED ORAL 20150514 NDA NDA021926 Pernix Therapeutics SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM 85; 500 mg/1; mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65224-860_d653af2d-0d84-471c-b996-8cbd18b29ccc 65224-860 HUMAN PRESCRIPTION DRUG Treximet Sumatriptan Succinate and Naproxen Sodium TABLET, FILM COATED ORAL 20150514 NDA NDA021926 Pernix Therapeutics SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM 10; 60 mg/1; mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65224-880_5d167b1f-e6e7-353b-e053-2991aa0a3d1d 65224-880 HUMAN PRESCRIPTION DRUG KHEDEZLA Extended-release desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130710 NDA NDA204683 Pernix Therapeutics DESVENLAFAXINE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 65224-890_5d167b1f-e6e7-353b-e053-2991aa0a3d1d 65224-890 HUMAN PRESCRIPTION DRUG KHEDEZLA Extended-release desvenlafaxine TABLET, EXTENDED RELEASE ORAL 20130710 NDA NDA204683 Pernix Therapeutics DESVENLAFAXINE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 65241-0001_8f5cb987-b4c0-4d82-81bb-0c148d570148 65241-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19991008 UNAPPROVED MEDICAL GAS Columbia Medical Equipment, Inc. OXYGEN 99 L/100L E 20171231 65248-001_a048123c-c210-499a-85e7-bb5e85580d0c 65248-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19930101 UNAPPROVED MEDICAL GAS Genter Healthcare, Inc OXYGEN 99 L/100L N 20181231 65250-133_a0d004eb-0186-4e2f-9fec-f202f49b46cc 65250-133 HUMAN PRESCRIPTION DRUG EXPAREL bupivacaine INJECTION, SUSPENSION, LIPOSOMAL INFILTRATION 20160101 NDA NDA022496 Pacira Pharmaceuticals Inc. BUPIVACAINE 13.3 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 65250-266_a0d004eb-0186-4e2f-9fec-f202f49b46cc 65250-266 HUMAN PRESCRIPTION DRUG EXPAREL bupivacaine INJECTION, SUSPENSION, LIPOSOMAL INFILTRATION 20120101 NDA NDA022496 Pacira Pharmaceuticals Inc. BUPIVACAINE 13.3 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 65255-409_2c7fc54b-3301-4c97-a2fa-3e20f5360b21 65255-409 HUMAN OTC DRUG Selenium sulfide SELENIUM SULFIDE SHAMPOO TOPICAL 20120208 OTC MONOGRAPH FINAL part358H Sonar Products, Inc SELENIUM SULFIDE 10 mg/mL E 20171231 65257-001_3a828edd-db47-45ad-aed5-66e7f4461dcf 65257-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS AlpinAire Healthcare OXYGEN 99 L/100L E 20171231 65278-007_318b93ed-05e9-4e0a-868a-f421e173bfc4 65278-007 HUMAN OTC DRUG Peter Thomas Roth CC Light to Medium Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20130222 OTC MONOGRAPH FINAL part352 June Jacobs Laboratories LLC TITANIUM DIOXIDE; ZINC OXIDE 102.6; 57.6 mg/mL; mg/mL E 20171231 65282-1505_57974c81-748f-682e-e053-2a91aa0a84b1 65282-1505 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20170721 ANDA ANDA206171 Spectra Medical Devices, Inc. SODIUM CHLORIDE 9 mg/mL N 20181231 65282-1510_57974c81-748f-682e-e053-2a91aa0a84b1 65282-1510 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20170721 ANDA ANDA206171 Spectra Medical Devices, Inc. SODIUM CHLORIDE 9 mg/mL N 20181231 65293-001_2a108b35-deed-460f-9efb-286583b17910 65293-001 HUMAN PRESCRIPTION DRUG Angiomax bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20001215 NDA NDA020873 The Medicines Company BIVALIRUDIN 250 mg/1 Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 65293-003_e16d2568-1d43-420c-a2b4-850f85861271 65293-003 HUMAN PRESCRIPTION DRUG KENGREAL cangrelor INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150708 NDA NDA204958 The Medicines Company CANGRELOR 50 mg/1 P2Y12 Platelet Inhibitor [EPC],Decreased Platelet Aggregation [PE],P2Y12 Receptor Antagonists [MoA] N 20181231 65293-005_c8c2dc00-90a3-11e4-b4a9-0800200c9a66 65293-005 HUMAN PRESCRIPTION DRUG Cleviprex clevidipine EMULSION INTRAVENOUS 20080915 NDA NDA022156 The Medicines Company CLEVIDIPINE .5 mg/mL Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65293-006_b62b217c-4f03-44cf-b038-84bbc84c9179 65293-006 PLASMA DERIVATIVE RECOTHROM Thrombin topical Recombinant KIT 20080129 BLA BLA125248 The Medicines Company E 20171231 65293-007_b62b217c-4f03-44cf-b038-84bbc84c9179 65293-007 PLASMA DERIVATIVE RECOTHROM Thrombin topical Recombinant KIT 20080609 BLA BLA125248 The Medicines Company E 20171231 65293-009_580db23f-c656-3049-e053-2a91aa0ad616 65293-009 HUMAN PRESCRIPTION DRUG VABOMERE Meropenem-Vaborbactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20171002 NDA NDA209776 The Medicines Company VABORBACTAM; MEROPENEM 1; 1 g/2g; g/2g beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 65293-011_45eac440-fb43-3509-e054-00144ff8d46c 65293-011 HUMAN PRESCRIPTION DRUG IONSYS fentanyl iontophoretic transdermal system PATCH TRANSDERMAL 20150601 NDA NDA021338 The Medicines Company FENTANYL HYDROCHLORIDE 40 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 65293-014_01511b8f-ca97-4772-b450-fd57c09df9d5 65293-014 HUMAN PRESCRIPTION DRUG Minocin minocycline hydrochloride INJECTION INTRAVENOUS 20130419 NDA NDA050444 The Medicines Company MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 65293-015_80202a4d-bc0d-49ab-9e76-0651e5ceea79 65293-015 HUMAN PRESCRIPTION DRUG Orbactiv oritavancin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140901 NDA NDA206334 The Medicines Company ORITAVANCIN 400 mg/1 Lipoglycopeptide Antibacterial [EPC],Lipoglycopeptides [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA] N 20181231 65293-373_b9f66652-ab43-48f1-8da9-05c9efe6869b 65293-373 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20091118 ANDA ANDA076972 The Medicines Company ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 65293-374_b9f66652-ab43-48f1-8da9-05c9efe6869b 65293-374 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON HYDROCHLORIDE INJECTION INTRAMUSCULAR; INTRAVENOUS 20091118 ANDA ANDA076974 The Medicines Company ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 65293-411_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-411 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 65293-412_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-412 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000710 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 65293-413_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-413 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 65293-414_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-414 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 65293-415_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-415 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 65293-416_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-416 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 65293-417_7ad32932-64e4-4cc5-b749-bc1a737df391 65293-417 HUMAN PRESCRIPTION DRUG Midazolam MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20000714 ANDA ANDA075154 The Medicines Company MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 65293-426_515789db-9048-40fe-ba91-ce61ddcd6f4e 65293-426 HUMAN PRESCRIPTION DRUG Rocuronium ROCURONIUM BROMIDE INJECTION, SOLUTION INTRAVENOUS 20091213 ANDA ANDA078651 The Medicines Company ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] E 20171231 65293-427_515789db-9048-40fe-ba91-ce61ddcd6f4e 65293-427 HUMAN PRESCRIPTION DRUG Rocuronium ROCURONIUM BROMIDE INJECTION, SOLUTION INTRAVENOUS 20091213 ANDA ANDA078651 The Medicines Company ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] E 20171231 65300-123_cbdc4154-fe7b-4911-a970-cd19df421568 65300-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS NASAL 20000101 UNAPPROVED MEDICAL GAS Medox Healthcare OXYGEN 210 mL/L E 20171231 65300-123_e94e14cb-c46d-4329-a2e1-9765f9ca9a2a 65300-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS NASAL 20000101 UNAPPROVED MEDICAL GAS Medox Healthcare OXYGEN 210 mL/L E 20171231 65302-029_605220b0-cd63-7cb9-e053-2a91aa0ac182 65302-029 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride Levalbuterol Hydrochloride INHALANT RESPIRATORY (INHALATION) 20180131 ANDA ANDA203653 The Ritedose Corporation LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 65302-030_605220b0-cd63-7cb9-e053-2a91aa0ac182 65302-030 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride Levalbuterol Hydrochloride INHALANT RESPIRATORY (INHALATION) 20180131 ANDA ANDA203653 The Ritedose Corporation LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 65302-031_605220b0-cd63-7cb9-e053-2a91aa0ac182 65302-031 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride Levalbuterol Hydrochloride INHALANT RESPIRATORY (INHALATION) 20180131 ANDA ANDA203653 The Ritedose Corporation LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 65310-002_5225be8f-6cd9-4cc6-b3e8-e9e4e13d5488 65310-002 HUMAN OTC DRUG No7 Protect and Perfect Intense Day Cream Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20121219 OTC MONOGRAPH NOT FINAL part352 Packaging Systems LLC AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.5; 2; 1 g/50g; g/50g; g/50g E 20171231 65321-011_92b3925e-8c09-41af-b7ad-6247b1ef894d 65321-011 HUMAN OTC DRUG Moisturizing Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20100225 OTC MONOGRAPH NOT FINAL part333E Rubbermaid Commercial Products LLC ALCOHOL 63 mL/100mL N 20181231 65321-012_63786a03-8a36-4a4b-8344-89bbaedffce2 65321-012 HUMAN OTC DRUG TC EnrichedFoam Antibacterial Triclosan SOAP TOPICAL 20100302 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC TRICLOSAN .5 g/100mL E 20171231 65321-013_cd854241-ae63-405d-bde3-a1b6fc7890b9 65321-013 HUMAN OTC DRUG TC EnrichedFoam Alcohol Hand Sanitizer Alcohol LIQUID TOPICAL 20100226 OTC MONOGRAPH NOT FINAL part333E Rubbermaid Commercial Products LLC ALCOHOL 67 mL/100mL N 20181231 65321-014_afdcf979-c4c8-48d4-b446-e7fd82d35889 65321-014 HUMAN OTC DRUG TC EnrichedFoam Alcohol-Free Instant Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100226 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 65321-017_798e7ec1-d671-456d-9447-f1a8cc816731 65321-017 HUMAN OTC DRUG TC SpraySoap Triclosan LIQUID TOPICAL 20100304 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC TRICLOSAN .5 g/100mL E 20171231 65321-019_8d84a103-fbd0-4047-bc88-751b8cb30ab7 65321-019 HUMAN OTC DRUG Foaming Hand Sanitizer Alcohol LIQUID TOPICAL 20100420 OTC MONOGRAPH NOT FINAL part333 Rubbermaid Commercial Products LLC ALCOHOL 67 mL/100mL N 20181231 65321-020_9d88824f-7020-4c0a-9fa3-05ed7e9cc1eb 65321-020 HUMAN OTC DRUG Foam Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC TRICLOSAN .3 g/100mL E 20171231 65321-021_b850881f-86a8-40df-90fe-375d1b203383 65321-021 HUMAN OTC DRUG TC Enrichedlotion Antibacterial Hand Wash Triclosan SOAP TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC TRICLOSAN .3 g/100mL E 20171231 65321-022_c968c03f-30c6-40d0-8441-8e58f16ee822 65321-022 HUMAN OTC DRUG Foam Hand Sanitizer Alcohol LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC ALCOHOL 75 mL/100mL E 20171231 65321-023_c49c456d-69b3-41dd-920b-c6f351abf6fa 65321-023 HUMAN OTC DRUG TC EnrichedFoam Alcohol-Free Plus Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 65321-024_5caedeb7-d37a-42e6-bf26-35ad3564a4f1 65321-024 HUMAN OTC DRUG Foam Hand Sanitizer Alcohol LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333E Rubbermaid Commercial Products LLC ALCOHOL 75 mL/100mL N 20181231 65321-025_17a6e144-8642-4f15-b51f-d366451d0974 65321-025 HUMAN OTC DRUG Foam Hand Sanitizer Alcohol LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC ALCOHOL 75 mL/100mL E 20171231 65321-026_79d32a89-3a09-4ae1-ac0e-ce0bbaf63c72 65321-026 HUMAN OTC DRUG TC EnrichedFoam Alcohol-Free Plus Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 65321-027_e0f55bdc-b252-409e-ab42-42dea557215c 65321-027 HUMAN OTC DRUG TC EnrichedFoam Alcohol-Free Plus Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20100501 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 65321-030_fd1b691f-34c0-4659-9b18-ae09ca2f3b78 65321-030 HUMAN OTC DRUG EnrichedFoam Alcohol-Free Hand Sanitizer Benzethonium Chloride LIQUID TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC BENZETHONIUM CHLORIDE .1 g/100mL N 20191231 65321-031_1862656d-58bf-496c-9845-dd205c38c28a 65321-031 HUMAN OTC DRUG Antibacterial Benzalkonium Chloride SOAP TOPICAL 20170724 OTC MONOGRAPH NOT FINAL part333E Rubbermaid Commercial Products LLC BENZALKONIUM CHLORIDE 13 mg/10mL N 20181231 65321-032_abab4a24-2e8d-441d-a590-ad40f42c5608 65321-032 HUMAN OTC DRUG Antibacterial Hand Wash Benzalkonium Chloride SOAP TOPICAL 20170724 OTC MONOGRAPH NOT FINAL part333E Rubbermaid Commercial Products LLC BENZALKONIUM CHLORIDE 13 mg/10mL N 20181231 65321-033_212794b8-0231-431c-bab5-7f45c9f09877 65321-033 HUMAN OTC DRUG Enriched Foam Alcohol-Free Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part333A Rubbermaid Commercial Products LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 65321-515_1746709c-7423-427c-9334-d673f8b6e0ac 65321-515 HUMAN OTC DRUG TC Instant Hand Sanitizer alcohol GEL TOPICAL 20110304 OTC MONOGRAPH NOT FINAL part333E Rubbermaid Commercial Products ALCOHOL 600 mL/1000mL E 20171231 65342-0001_c3cdc21a-13ce-4541-8153-3a4504f4cbcc 65342-0001 HUMAN OTC DRUG laura mercier tinted moisturizer Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage CAMEO OCTINOXATE, OCTISALATE CREAM TOPICAL 20130206 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-0002_c4a6520f-6055-4b62-b691-075c4f930c18 65342-0002 HUMAN OTC DRUG laura mercier tinted moisturizer Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage NATURAL OCTINOXATE, OCTISALATE CREAM TOPICAL 20130206 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-0003_a17314eb-4862-4673-9508-d248ff64329c 65342-0003 HUMAN OTC DRUG laura mercier tinted moisturizer Broad Spectrum SPF 20 Sunscreen Lightweight Flawless Coverage OCHRE OCTINOXATE, OCTISALATE CREAM TOPICAL 20130206 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-0150_3063406e-296b-0fe6-e054-00144ff8d46c 65342-0150 HUMAN OTC DRUG Laura Mercier Flawless Skin Repair Oil Free Day Broad Spectrum SPF 15 AVOBENZONE, OCTINOXATE, OXYBENZONE LOTION TOPICAL 20160413 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTINOXATE; OXYBENZONE 8; 35; 5 mg/mL; mg/mL; mg/mL E 20171231 65342-0940_7dd18f7f-0678-424b-bcef-02a2a9b2a55a 65342-0940 HUMAN OTC DRUG Laura Mercier Flawless Skin Moisture Creme Broad Spectrum SPF 15 Sunscreen for Normal/Combination Skin Flawless skin Mega Moisturizer SPF-15 NORMAL COMBINATION AVOBENZONE, OCTINOXATE CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/g; mg/g E 20171231 65342-0945_0457d6da-3cc2-458f-b558-6ff0f7f44d1a 65342-0945 HUMAN OTC DRUG Laura Mercier Flawless Skin Mega Moisture Creme Broad Spectrum SPF 15 Sunscreen for Normal/Dry Skin AVOBENZONE, OCTINOXATE CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/g; mg/g N 20181231 65342-0947_3d68e9fd-e272-4905-983e-45675281b9e0 65342-0947 HUMAN OTC DRUG Laura mercier Moisturizer cream with SPF 15 Octinoxate ,Avobenzone CREAM TOPICAL 20090301 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; AVOBENZONE 3.75; 1 g/50g; g/50g E 20171231 65342-1230_60ef3d14-a4f9-8188-e053-2991aa0a6df6 65342-1230 HUMAN OTC DRUG ReVive Fermitif Neck Renewal SPF 15 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 20; 60; 27; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 65342-1377_731421bb-5418-4cd0-b9c7-fe8713f93d3e 65342-1377 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Nude MERADIMATE, OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL E 20171231 65342-1377_82ffdfba-cac6-46e1-906c-005d650047a7 65342-1377 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Nude Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; MERADIMATE 3; 1.4 mg/40mg; mg/40mg E 20171231 65342-1378_110e1ed9-6aef-4b0c-b399-af02dc6d3de1 65342-1378 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Sand MERADIMATE,OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL N 20181231 65342-1378_60d26e79-1bcd-4044-bb9b-a62009ed1285 65342-1378 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Sand Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; MERADIMATE 3; 1.4 mg/40mg; mg/40mg N 20181231 65342-1379_6ae787ab-cefb-4ea4-90bc-0959dfadd7af 65342-1379 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Almond MERADIMATE,OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL N 20181231 65342-1379_f62df615-1d8f-491b-9bd3-b3dbc89e979f 65342-1379 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Almond Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; MERADIMATE 3; 1.4 mg/40mg; mg/40mg N 20181231 65342-1380_83fc683e-108a-4d0f-963f-90905af57ce9 65342-1380 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Tan Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; MERADIMATE 3; 1.4 mg/40mg; mg/40mg N 20181231 65342-1380_d19c02ba-2271-4c92-837f-d6b186be8eb9 65342-1380 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Tan MERADIMATE,OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL N 20181231 65342-1381_7cb4f213-00cb-4b41-8b77-18f844a928fd 65342-1381 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Porcelain MERADIMATE, OCTINOXATE CREAM TOPICAL 20150708 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL E 20171231 65342-1381_81ef832d-b646-4462-9c45-881084d0b18f 65342-1381 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Porcelain Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; MERADIMATE 3; 1.4 mg/40mg; mg/40mg E 20171231 65342-1382_e9fcdbf9-8ae3-4070-b891-5541c2e628e4 65342-1382 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Blush AVOBENZONE,OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 65342-1383_81c9ffa8-541a-4dd9-9ca8-da357149ccbe 65342-1383 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Cameo AVOBENZONE,OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 65342-1384_35a8a4b5-9b0f-4f47-bf1c-1d8b18e85a56 65342-1384 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Natural AVOBENZONE,OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 65342-1385_b460ee2f-ed59-449f-a1e8-82bfc174bdb7 65342-1385 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Ochre AVOBENZONE, OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 65342-1386_7e464d4c-44c4-428e-a32c-53ea2aabb45d 65342-1386 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Tawny AVOBENZONE,OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 65342-1387_2a10cb14-efb9-4c48-b08b-8fe090bff314 65342-1387 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer - Illuminating Broad Spectrum SPF 20 Sunscreen - Natural Radiance AVOBENZONE, OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL E 20171231 65342-1390_77338f2a-fa61-4fc6-b9a4-9599280d94c3 65342-1390 HUMAN OTC DRUG Tinted Moisturizer SPF 20 Bisque Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; AVOBENZONE 3; .8 mL/40mL; mL/40mL N 20181231 65342-1390_9b433d44-c43f-4378-8d96-23301a1001f6 65342-1390 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Bisque AVOBENZONE,OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 65342-1391_476b5c1c-5735-4a77-82d2-0956d4cdffef 65342-1391 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Caramel AVOBENZONE,OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 65342-1391_4ac44ccb-c086-42c0-8fd1-e1f277feaa63 65342-1391 HUMAN OTC DRUG Tinted Moisturizer SPF-20 Caramel Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; AVOBENZONE 3; .8 mL/40mL; mL/40mL N 20181231 65342-1392_852ecb7c-338f-472a-bf4a-cfd8585db59b 65342-1392 HUMAN OTC DRUG Tinted Moisturizer SPF-20 Mocha Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; AVOBENZONE 3; .8 mL/40mL; mL/40mL N 20181231 65342-1392_93aa0054-213e-4a53-99b9-0e53e75dfbdf 65342-1392 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Mocha AVOBENZONE,OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 65342-1393_3bdc9aa8-c13d-4c3e-b157-243f7aa47b3c 65342-1393 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer - Illuminating Broad Spectrum SPF 20 Sunscreen - Golden Radiance AVOBENZONE, OCTINOXATE CREAM TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL E 20171231 65342-1393_c7f4c10a-0b62-4586-b94f-7a64f9bf70d0 65342-1393 HUMAN OTC DRUG Tinted Moisturizer SPF-20 Golden Radiance Octinoxate ,Avobenzone CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; AVOBENZONE 3; .8 mL/40mL; mL/40mL E 20171231 65342-1394_194c6901-589b-4c19-a4cf-5a05d0084ee3 65342-1394 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer - Illuminating Broad Spectrum SPF 20 Sunscreen - Bronze Radiance AVOBENZONE, OCTINOXATE CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 65342-1395_d2e0e1a7-fac4-41d1-a4d1-8facf0aac983 65342-1395 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer - Illuminating Broad Spectrum SPF 20 Sunscreen - Warm Radiance AVOBENZONE, OCTINOXATE CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 65342-1396_861b51a4-37e3-4f83-b81c-1047164d1d6e 65342-1396 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer - Illuminating Broad Spectrum SPF 20 Sunscreen - Bare Radiance AVOBENZONE, OCTINOXATE CREAM TOPICAL 20101129 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. AVOBENZONE; OCTINOXATE 20; 75 mg/mL; mg/mL N 20181231 65342-1400_aed41381-2f4a-4d63-98db-c3e708e5fbe0 65342-1400 HUMAN OTC DRUG ReVive Even Skin Tone Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20150805 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 10; 50 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 65342-1401_4189890d-449a-49c4-92e7-6d2f9052334c 65342-1401 HUMAN OTC DRUG ReVive Sensitif Oil Free Broad Spectrum SPF 15 Sunscreen AVOBENZONE, OCTINOXATE CREAM TOPICAL 20150806 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products LLC AVOBENZONE; OCTINOXATE 30; 75 mg/g; mg/g E 20171231 65342-1402_5cacb5fb-9547-4a35-a616-149b89c386bf 65342-1402 HUMAN OTC DRUG ReVive Sensitif Renewal Daily Cellular Protection Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20150806 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 10; 50 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 65342-1403_479fc953-749c-4d0e-8083-d74efe6e631a 65342-1403 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Nude MERADIMATE, OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 35; 75 mg/g; mg/g E 20171231 65342-2000_60e1f7d2-8c71-1157-e053-2a91aa0aecb0 65342-2000 HUMAN OTC DRUG LAURA MERCIER TINTED MOISTURIZER SPF 20 TAN OCTINOXATE, OCTISALATE CREAM TOPICAL 20110421 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-2010_60e1f386-86e8-0e78-e053-2a91aa0a5103 65342-2010 HUMAN OTC DRUG LAURA MERCIER TINTED MOISTURIZER SPF 20 Almond OCTINOXATE, OCTISALATE CREAM TOPICAL 20170914 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-2020_60e1f7d2-8c8a-1157-e053-2a91aa0aecb0 65342-2020 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 SAND OCTINOXATE, OCTISALATE CREAM TOPICAL 20110421 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-2030_60e1f5d3-6173-6118-e053-2991aa0a3023 65342-2030 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer SPF 20 MOCHA OCTINOXATE, OCTISALATE CREAM TOPICAL 20171027 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-2040_60e21927-3071-32cb-e053-2a91aa0ad44e 65342-2040 HUMAN OTC DRUG LAURA MERCIER TINTED MOISTURIZER SPF 20 Bisque OCTINOXATE, OCTISALATE CREAM TOPICAL 20110428 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-2050_60e215c3-5bb1-126c-e053-2991aa0a03dd 65342-2050 HUMAN OTC DRUG LAURA MERCIER TINTED MOISTURIZER SPF 20 Porcelain OCTINOXATE, OCTISALATE CREAM TOPICAL 20110428 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-2060_60e21927-308c-32cb-e053-2a91aa0ad44e 65342-2060 HUMAN OTC DRUG LAURA MERCIER TINTED MOISTURIZER SPF 20 Walnut OCTINOXATE, OCTISALATE CREAM TOPICAL 20170914 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-2070_60e22487-89cf-3a8e-e053-2a91aa0a2b55 65342-2070 HUMAN OTC DRUG LAURA MERCIER TINTED MOISTURIZER SPF 20 Fawn OCTINOXATE, OCTISALATE CREAM TOPICAL 20170914 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-2080_60e223f9-2b70-46fd-e053-2a91aa0a9cf5 65342-2080 HUMAN OTC DRUG LAURA MERCIER TINTED MOISTURIZER SPF 20 CARAMEL OCTINOXATE, OCTISALATE CREAM TOPICAL 20170914 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-2090_60e22d03-304b-3060-e053-2991aa0a3faf 65342-2090 HUMAN OTC DRUG LAURA MERCIER TINTED MOISTURIZER SPF 20 NUDE OCTINOXATE, OCTISALATE CREAM TOPICAL 20170913 OTC MONOGRAPH FINAL part352 Gurwitch Products OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-2100_60e23697-5631-5971-e053-2a91aa0ae9a5 65342-2100 HUMAN OTC DRUG LAURA MERCIER TINTED MOISTURIZER SPF 20 Tawny OCTINOXATE, OCTISALATE CREAM TOPICAL 20170913 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTISALATE; OCTINOXATE 30; 55 mg/mL; mg/mL N 20181231 65342-2101_592b1faa-7271-e1f2-e053-2991aa0a2c65 65342-2101 HUMAN OTC DRUG LAURA MERCIER TINTED MOISTURIZER SPF 20 Blush OCTINOXATE, OCTISALATE CREAM TOPICAL 20170913 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; OCTISALATE 55; 30 mg/mL; mg/mL N 20181231 65342-2320_c71c48ce-7c26-42c4-a736-d99536980035 65342-2320 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Walnut SPF-20 Walnut Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; MERADIMATE 3; 1.4 mg/40mg; mg/40mg E 20171231 65342-2340_60ef3d14-a56c-8188-e053-2991aa0a6df6 65342-2340 HUMAN OTC DRUG Laura Mercier Flawless Skin Daily Face Shield SPF 40 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20110421 OTC MONOGRAPH FINAL part352 Gurwitch Products, LLC OCTINOXATE; TITANIUM DIOXIDE 75; 50 mg/mL; mg/mL N 20191231 65342-2963_bb09a843-bba9-4c61-ad28-afae80a35f31 65342-2963 HUMAN OTC DRUG Laura mercier Tinted Moisturizer SPF-20 Fawn Octinoxate ,Meradimate CREAM TOPICAL 20050313 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. OCTINOXATE; MERADIMATE 3; 1.4 mg/40mg; mg/40mg N 20181231 65342-2963_e60ad921-1fd7-4e6e-8598-03a5bc24bef7 65342-2963 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Fawn MERADIMATE,OCTINOXATE CREAM TOPICAL 20150709 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, L.L.C. MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL N 20181231 65342-5000_72b2e5ac-df41-4887-b9c8-b7aad625d268 65342-5000 HUMAN OTC DRUG Laura mercier flawless skin repair oil free Day Broad Spectrum SPF 15 OCTINOXATE LOTION TOPICAL 20141230 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC OCTINOXATE 35 mg/mL E 20171231 65342-5100_c42945db-0b27-402c-b5d9-6225902603aa 65342-5100 HUMAN OTC DRUG Laura mercier flawless skin repair Day Broad Spectrum SPF 15 OCTINOXATE CREAM TOPICAL 20141231 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC OCTINOXATE 35 mg/mL E 20171231 65342-7001_a9fe4c82-3c58-49de-9016-bf16d1d616c1 65342-7001 HUMAN OTC DRUG Laura Mercier Foundation Primer Protect SPF 30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 30; 73; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65342-7003_a9fe4c82-3c58-49de-9016-bf16d1d616c1 65342-7003 HUMAN OTC DRUG Laura Mercier Foundation Primer Protect SPF 30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 30; 73; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65342-7005_a9fe4c82-3c58-49de-9016-bf16d1d616c1 65342-7005 HUMAN OTC DRUG Laura Mercier Foundation Primer Protect SPF 30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 30; 73; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65342-7500_457119e5-1f4b-3462-e054-00144ff88e88 65342-7500 HUMAN OTC DRUG Laura Mercier Flawless Skin Repair Day Broad Spectrum SPF 15 Sunscreen AVOBENZONE, OCTINOXATE, OXYBENZONE CREAM TOPICAL 20170105 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC AVOBENZONE; OCTINOXATE; OXYBENZONE 8; 35; 5 mg/mL; mg/mL; mg/mL N 20181231 65342-7600_457119e5-1f79-3462-e054-00144ff88e88 65342-7600 HUMAN OTC DRUG Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Walnut MERADIMATE, OCTINOXATE CREAM TOPICAL 20170105 OTC MONOGRAPH NOT FINAL part352 Gurwitch Products, LLC MERADIMATE; OCTINOXATE 35; 75 mg/mL; mg/mL N 20181231 65360-1073_33aab730-8188-4b53-9bc2-f9e0230d1f6a 65360-1073 HUMAN PRESCRIPTION DRUG Liquid Oxygen Liquid Oxygen GAS RESPIRATORY (INHALATION) 19990102 UNAPPROVED MEDICAL GAS Community Home Health Services OXYGEN 995 mL/L E 20171231 65364-100_480818b5-84ac-4386-e054-00144ff8d46c 65364-100 HUMAN OTC DRUG Kiss My Face - Oat Protein Complex SPF 18 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part352 Kiss My Face LLC TITANIUM DIOXIDE; ZINC OXIDE 4.25; 3.75 g/100mL; g/100mL N 20181231 65364-110_4807fb60-8d36-6e61-e054-00144ff8d46c 65364-110 HUMAN OTC DRUG Kiss My Face - Oat Protein Complex SPF 30 OCTINOXATE, OCTISALATE, ZINC OXIDE LOTION TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part352 65364-110 OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 3; 4.5 g/100mL; g/100mL; g/100mL N 20181231 65364-120_48083db1-f407-16f5-e054-00144ff88e88 65364-120 HUMAN OTC DRUG Kiss My Face - Face Factor SPF 30 OCTINOXATE, OCTISALATE, ZINC OXIDE LOTION TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part352 Kiss My Face LLC OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 3; 3 g/100mL; g/100mL; g/100mL N 20181231 65364-210_48083db1-f427-16f5-e054-00144ff88e88 65364-210 HUMAN OTC DRUG KISS MY FACE SUNSCREEN face factor broad spectrum spf 30 OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20150109 OTC MONOGRAPH NOT FINAL part352 Kiss My Face LLC OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 30; 30 mg/mL; mg/mL; mg/mL N 20181231 65364-211_48083db1-f438-16f5-e054-00144ff88e88 65364-211 HUMAN OTC DRUG KISS MY FACE MINERAL SUNSCREEN obsessively natural KIDS defense broad spectrum spf 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150109 OTC MONOGRAPH NOT FINAL part352 Kiss My Face LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 65364-212_48083db1-f447-16f5-e054-00144ff88e88 65364-212 HUMAN OTC DRUG KISS MY FACE MINERAL SUNSCREEN sun broad spectrum spf 30 TITANIUM DIOXIDE, ZINC OXIDE SPRAY TOPICAL 20150109 OTC MONOGRAPH NOT FINAL part352 Kiss My Face LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 65364-213_480843e6-9c71-0ae1-e054-00144ff8d46c 65364-213 HUMAN OTC DRUG KISS MY FACE SUNSCREEN sun broad spectrum spf 30 AVOBENZONE, OCTINOXATE, OCTISALATE SPRAY TOPICAL 20150109 OTC MONOGRAPH NOT FINAL part352 Kiss My Face LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 65364-214_480843e6-9c44-0ae1-e054-00144ff8d46c 65364-214 HUMAN OTC DRUG KISS MY FACE SUNSCREEN COOL SPORT broad spectrum spf 30 OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20150109 OTC MONOGRAPH NOT FINAL part352 Kiss My Face LLC OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 40; 25 mg/mL; mg/mL; mg/mL N 20181231 65364-215_480843e6-9c80-0ae1-e054-00144ff8d46c 65364-215 HUMAN OTC DRUG KISS MY FACE organics KIDS MINERAL SUNSCREEN broad spectrum spf 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150109 OTC MONOGRAPH NOT FINAL part352 Kiss My Face LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 65364-216_4934a7a8-43b4-727a-e054-00144ff88e88 65364-216 HUMAN OTC DRUG KISS MY FACE organics face and body MINERAL SUNSCREEN broad spectrum spf 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150109 OTC MONOGRAPH NOT FINAL part352 Kiss My Face LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 65364-217_48083db1-f462-16f5-e054-00144ff88e88 65364-217 HUMAN OTC DRUG KISS MY FACE SUNSCREEN TATTOO SHADE broad spectrum spf 30 OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20150109 OTC MONOGRAPH NOT FINAL part352 Kiss My Face LLC OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 45; 30 mg/mL; mg/mL; mg/mL N 20181231 65364-218_c9c86d45-0999-4b7d-81c1-9605fec5192d 65364-218 HUMAN OTC DRUG Sunspray Avobenzone, Homosalate, Octinoxate, Octisalate, Titanium Dioxide SPRAY TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Kiss My Face, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 5; 7.5; 6.5; 2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 65364-219_00e28aae-368c-45ac-97aa-002f3308f1e1 65364-219 HUMAN OTC DRUG Face Factor Avobenzone, Homosalate, Octinoxate, Octisalate, Titanium Dioxide LOTION TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Kiss My Face, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 6; 7.5; 5; 3 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 65364-220_0114c2bc-17ad-44d6-b511-ab8b0bfc3a69 65364-220 HUMAN OTC DRUG Kiss My Face SPF 30 Lip Balm Avobenzone, Homosalate, Octinoxate, Octocrylene STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Kiss My Face OCTINOXATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE 7; 2; 3; 8 mg/g; mg/g; mg/g; mg/g N 20181231 65364-221_d79f7dff-0ebb-473a-9486-0e4c90c1e2a1 65364-221 HUMAN OTC DRUG Kiss My Face SPF 30 Sport Lip Balm Avobenzone, Homosalate, Octinoxate, Octocrylene STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Kiss My Face OCTINOXATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE 7; 2; 3; 8 mg/g; mg/g; mg/g; mg/g N 20181231 65364-222_0f399ea5-d99a-44cf-85a1-071f5f88b65e 65364-222 HUMAN OTC DRUG Kiss My Face SPF 30 Sport Treatmint Lip Balm Avobenzone, Homosalate, Octinoxate, Octocrylene STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Kiss My Face OCTINOXATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE 7; 2; 3; 8 mg/g; mg/g; mg/g; mg/g N 20181231 65364-223_811317d4-e3ab-4358-8edd-abe67168d547 65364-223 HUMAN OTC DRUG Kiss My Face SPF 30 Face Stick Avobenzone, Homosalate, Octinoxate, Octocrylene STICK TOPICAL 20140509 OTC MONOGRAPH NOT FINAL part352 Kiss My Face OCTINOXATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE 7; 2; 3; 8 mg/g; mg/g; mg/g; mg/g N 20181231 65364-380_63228a44-047a-9cbd-e053-2991aa0a9165 65364-380 HUMAN OTC DRUG KISS MY FACE SPF-15 DRY AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE LIQUID TOPICAL 20180112 OTC MONOGRAPH NOT FINAL part352 Kiss My Face, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 30; 20; 40; 30 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 65364-381_6322396e-df11-907a-e053-2a91aa0a52f0 65364-381 HUMAN OTC DRUG KISS MY FACE SPF-50 Face Factor AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE,OCTOCRYLENE CREAM TOPICAL 20180112 OTC MONOGRAPH NOT FINAL part352 Kiss My Face, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 20; 75; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 65364-382_6322cd26-6e89-0af9-e053-2991aa0a6deb 65364-382 HUMAN OTC DRUG KISS MY FACE ORGANICS SPF-30 MINERAL SUN TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20180119 OTC MONOGRAPH NOT FINAL part352 Kiss My Face, LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20191231 65364-383_6322cd26-6e9a-0af9-e053-2991aa0a6deb 65364-383 HUMAN OTC DRUG KISS MY FACE ORGANICS SPF-30 MINERAL SUN TITANIUM DIOXIDE, ZINC OXIDE LIQUID TOPICAL 20180119 OTC MONOGRAPH NOT FINAL part352 Kiss My Face, LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20191231 65365-001_42756198-0a9e-427a-883a-4f64f8488327 65365-001 HUMAN OTC DRUG HAND SANITIZING GREEN APPLE ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mL/100mL E 20171231 65365-002_e4752d2c-1463-4940-93f8-6af8c91d2f60 65365-002 HUMAN OTC DRUG HAND SANITIZING MANDARIN ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mg/100mL E 20171231 65365-003_13186e87-9f79-494e-997d-9929cf7a3719 65365-003 HUMAN OTC DRUG HAND SANITIZING BLUEBERRY ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mg/100mL E 20171231 65365-004_8f3ae28f-c7ac-46bc-80fc-a5256cf20e3b 65365-004 HUMAN OTC DRUG HAND SANITIZING STRAWBERRY ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mL/100mL E 20171231 65365-005_7cf8c2f5-fe9c-4366-869c-582ca4c4b174 65365-005 HUMAN OTC DRUG HAND SANITIZING UNSCENTED ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mg/100mL E 20171231 65365-006_e35a9159-ae6a-484f-81a8-3c19eeae52cf 65365-006 HUMAN OTC DRUG HAND SANITIZING SPECIAL TEACHER GREEN APPLE ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mg/100mL E 20171231 65365-007_779a0099-2dc6-4f95-84ac-13774e829167 65365-007 HUMAN OTC DRUG HAND SANITIZING TEACHERS RULE MANDARIN ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mg/mL E 20171231 65365-008_1044980e-7348-474f-ba4c-8c3c78801f01 65365-008 HUMAN OTC DRUG HAND SANITIZING A PLUS TEACHER UNSCENTED ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Sigan Industries ALCOHOL 62 mg/100mL E 20171231 65365-284_56ef22ac-4225-0970-e054-00144ff88e88 65365-284 HUMAN OTC DRUG POMODA DRAGON PAIN NUMBING POMODA DRAGON PAIN NUMBING CREAM TOPICAL 20170816 OTC MONOGRAPH NOT FINAL part348 SIGAN INDUSTRIES GROUP LIDOCAINE HYDROCHLORIDE 40 mg/g N 20181231 65371-025_a248570a-8143-440d-8395-fc2be4548b08 65371-025 HUMAN OTC DRUG BB ANTI-FATIGUE ABSOLUTE SPF 25 HOMOSALATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part352 ORLANE S.A. HOMOSALATE; OCTISALATE; OXYBENZONE 90; 45; 30 mg/mL; mg/mL; mg/mL E 20171231 65371-030_b9041dc8-11d3-4251-8829-cf05b03fa911 65371-030 HUMAN OTC DRUG Extreme Anti-Wrinkle Care SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 ORLANE, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30.9; 103; 51.5; 103; 51.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65371-051_e7d6117a-8a96-43b4-8433-513f88704f0e 65371-051 HUMAN OTC DRUG Compact Foundation SPF 50 Color 01 Octinoxate, Octisalate, and Titanium Dioxide CREAM TOPICAL 20150801 OTC MONOGRAPH FINAL part352 ORLANE, Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 25; 62.5; 238.7 mg/mL; mg/mL; mg/mL E 20171231 65371-052_48a50a8c-af02-4290-9933-e67bc49d0e60 65371-052 HUMAN OTC DRUG Compact Foundation SPF 50 Color 02 Octinoxate, Octisalate, and Titanium Dioxide CREAM TOPICAL 20150801 OTC MONOGRAPH FINAL part352 ORLANE, Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 25; 62.5; 228.7 mg/mL; mg/mL; mg/mL E 20171231 65371-053_82f4d5a5-f1e4-40ae-b5b0-49c8b593a274 65371-053 HUMAN OTC DRUG Compact Foundation SPF 50 Color 03 Octinoxate, Octisalate, and Titanium Dioxide CREAM TOPICAL 20150801 OTC MONOGRAPH FINAL part352 ORLANE, Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 25; 62.5; 203.7 mg/mL; mg/mL; mg/mL E 20171231 65371-054_c4f616aa-6855-494c-89fb-3d936edf1a05 65371-054 HUMAN OTC DRUG Fluid Foundation SPF 30 Color 01 Avobenzone, Octinoxate, Octocrylene, and Titanium Dioxide CREAM TOPICAL 20160301 OTC MONOGRAPH FINAL part352 ORLANE, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 25; 62.5; 238.7; 238.7 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65371-055_7fac29f3-e95d-473a-88bf-ffcd29755c87 65371-055 HUMAN OTC DRUG Fluid Foundation SPF 30 Color 02 Avobenzone, Octinoxate, Octocrylene, and Titanium Dioxide CREAM TOPICAL 20160301 OTC MONOGRAPH FINAL part352 ORLANE, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 25; 62.5; 238.7; 238.7 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65371-056_c487d631-2a0d-48f3-a11f-7546319c1115 65371-056 HUMAN OTC DRUG Fluid Foundation SPF 30 Color 03 Avobenzone, Octinoxate, Octocrylene, and Titanium Dioxide CREAM TOPICAL 20160301 OTC MONOGRAPH FINAL part352 ORLANE, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 25; 62.5; 238.7; 238.7 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65373-100_e96c0c50-9c4d-4dc3-9eb8-481cabfc42fa 65373-100 HUMAN OTC DRUG Tineacide Physician Formula UNDECYLENIC ACID CREAM TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 13 g/100g N 20181231 65373-401_37672821-f011-4436-be93-a9c8832e26bf 65373-401 HUMAN OTC DRUG Ortho-Nesic With Capsaicin Menthol GEL TOPICAL 19950101 OTC MONOGRAPH FINAL part341 Blaine Labs Inc. MENTHOL; CAMPHOR (SYNTHETIC) 3.5; .2 g/100g; g/100g N 20181231 65373-500_e96c0c50-9c4d-4dc3-9eb8-481cabfc42fa 65373-500 HUMAN OTC DRUG Tineacide Undecylenic Acid CREAM TOPICAL 19950101 OTC MONOGRAPH FINAL part333C Blaine Labs Inc. UNDECYLENIC ACID 10 g/100g N 20181231 65386-0001_f3dae8f7-d5e4-4049-9551-a8a6b8ae57ca 65386-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990701 UNAPPROVED MEDICAL GAS Advacare Home Services OXYGEN 99 L/100L E 20171231 65402-0001_302c38e7-bcd2-4a74-a7b7-468b1d85d603 65402-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19991207 UNAPPROVED MEDICAL GAS Danes Welding Supplies Inc. OXYGEN 99 L/100L E 20171231 65435-0116_fdb6b8cf-f655-47b6-8052-623a40d2ff2a 65435-0116 HUMAN OTC DRUG Safe Sea Sunscreen With Jellyfish Sting Protective SPF 15 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20111112 OTC MONOGRAPH FINAL part352 Nidaria Technology Ltd. OCTINOXATE; ZINC OXIDE 7.5; 2 mL/100mL; mL/100mL E 20171231 65435-0131_f324182e-5d71-44b8-af54-6970728da556 65435-0131 HUMAN OTC DRUG Safe Sea Sunscreen With Jellyfish Sting Protective SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20111112 OTC MONOGRAPH FINAL part352 Nidaria Technology Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 65435-0133_2705bdfb-5d32-453e-8a0a-f824a57c5915 65435-0133 HUMAN OTC DRUG Safe Sea For Kids Sunscreen With Jellyfish Sting Protective SPF 30 Plus OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20111112 OTC MONOGRAPH FINAL part352 Nidaria Technology Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 65435-0151_e3d85083-3155-48c9-817c-74121784b505 65435-0151 HUMAN OTC DRUG Safe Sea Sunscreen With Jellyfish Sting Protective SPF 50 OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20111112 OTC MONOGRAPH FINAL part352 Nidaria Technology Ltd. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 7.5; 5; 5; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 65437-035_202d0e83-dbbd-48ab-b66a-920c68170dde 65437-035 HUMAN OTC DRUG SENNA LEAF and DOCUSATE SODIUM SENNA LEAF and DOCUSATE SODIUM TABLET, FILM COATED ORAL 20100401 OTC MONOGRAPH NOT FINAL part334 HIMPRIT PHARMACHEM PVT LTD SENNA LEAF; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 65437-036_34dbcd2a-11a4-4688-8efb-07e90a503c95 65437-036 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20100301 OTC MONOGRAPH FINAL part341 HIMPRIT PHARMACHEM PVT LTD DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 65437-037_8841b9a3-1a06-4828-9eef-bec7331b6206 65437-037 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20100301 OTC MONOGRAPH FINAL part338 HIMPRIT PHARMACHEM PVT LTD DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 65437-038_d2b2b80e-0e38-41bd-8e19-924863fbd11c 65437-038 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, FILM COATED ORAL 20100301 OTC MONOGRAPH FINAL part341 HIMPRIT PHARMACHEM PVT LTD ASPIRIN 325 mg/1 N 20181231 65437-040_dfdf9b9f-ecc3-4c25-8a5d-c744a9bb6651 65437-040 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET, FILM COATED ORAL 20100701 OTC MONOGRAPH FINAL part343 HIMPRIT PHARMACHEM PVT LTD ACETAMINOPHEN 500 mg/1 N 20181231 65437-041_13d391cd-6737-4d5d-a811-4cd602ec0013 65437-041 HUMAN OTC DRUG ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20100701 OTC MONOGRAPH NOT FINAL part343 HIMPRIT PHARMACHEM PVT LTD ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 65437-087_f06df412-c097-4acc-a2d3-277aaeb3b17a 65437-087 HUMAN OTC DRUG SENNA SENNA TABLET, FILM COATED ORAL 20091120 OTC MONOGRAPH FINAL part334 HIMPRIT PHARMACHEM PVT LTD SENNA 8.6 mg/1 N 20181231 65447-050_0ab6b7a0-0a50-4c11-bfbc-46ab66be5d28 65447-050 HUMAN OTC DRUG Cellular Day Defense Firming SPF 25 zinc oxide, oxybenzone, and octinoxate CREAM TOPICAL 20111015 OTC MONOGRAPH NOT FINAL part352 Aloette Cosmetics Inc. ZINC OXIDE; OXYBENZONE; OCTINOXATE 5; 3; 7.5 g/100g; g/100g; g/100g E 20171231 65447-377_debd3d72-5447-4dd5-9c9a-f15c3314d389 65447-377 HUMAN OTC DRUG Stay Pure Acne Treatment Salicylic Acid LOTION TOPICAL 20150101 OTC MONOGRAPH FINAL part333D Aloette SALICYLIC ACID 20 mg/mL N 20181231 65460-3111_a59b2ac2-a423-4f50-8b27-dd471859c51e 65460-3111 HUMAN OTC DRUG antimicrobial hand wipe Alcohol CLOTH TOPICAL 20091130 OTC MONOGRAPH FINAL part333 SAS Safety ALCOHOL .6 g/1 N 20181231 65465-0001_41764a77-d6d6-44f9-b355-ca3fdaccbf61 65465-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030501 UNAPPROVED MEDICAL GAS Apex of St. Peters OXYGEN 99 L/100L E 20171231 65468-001_264d63e6-4329-4440-af08-f26cdd5a8198 65468-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Valley Medical Shoppe OXYGEN 99 L/100L E 20171231 65483-093_6008addc-7f8e-45bb-8aec-54dd54a788ac 65483-093 HUMAN PRESCRIPTION DRUG RIDAURA auranofin CAPSULE ORAL 19850424 NDA NDA018689 Prometheus Laboratories Inc. AURANOFIN 3 mg/1 E 20171231 65483-116_b3294680-603d-42f9-a4c9-473213f6797a 65483-116 HUMAN PRESCRIPTION DRUG Proleukin aldesleukin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19920505 BLA BLA103293 Prometheus Laboratories Inc. ALDESLEUKIN 1.1 mg/mL Increased Lymphocyte Activation [PE],Increased Lymphocyte Cell Production [PE],Interleukin-2 [Chemical/Ingredient],Lymphocyte Growth Factor [EPC] N 20181231 65483-391_8d2825c1-c676-4a48-bb9f-e0e2b7cc9ee1 65483-391 HUMAN PRESCRIPTION DRUG Trandate labetalol hydrochloride TABLET ORAL 19840531 NDA NDA018716 Prometheus Laboratories Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 65483-392_8d2825c1-c676-4a48-bb9f-e0e2b7cc9ee1 65483-392 HUMAN PRESCRIPTION DRUG Trandate labetalol hydrochloride TABLET ORAL 19840531 NDA NDA018716 Prometheus Laboratories Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 65483-393_8d2825c1-c676-4a48-bb9f-e0e2b7cc9ee1 65483-393 HUMAN PRESCRIPTION DRUG Trandate labetalol hydrochloride TABLET ORAL 19840531 NDA NDA018716 Prometheus Laboratories Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 65483-590_52d9d9c5-cb11-4901-ab91-bc03805af972 65483-590 HUMAN PRESCRIPTION DRUG IMURAN azathioprine TABLET ORAL 19680320 NDA NDA016324 Prometheus Laboratories Inc. AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] E 20171231 65483-702_c99a57a5-655a-4ded-9397-eb7881a3e670 65483-702 HUMAN PRESCRIPTION DRUG ENTOCORT EC Budesonide CAPSULE ORAL 20011029 NDA NDA021324 Prometheus Laboratories Inc BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 65483-894_800b0802-c4e6-409f-adbc-a985d1fca2a5 65483-894 HUMAN PRESCRIPTION DRUG LOTRONEX alosetron hydrochloride TABLET ORAL 20090209 NDA NDA021107 Prometheus Laboratories Inc. ALOSETRON HYDROCHLORIDE .5 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 65483-895_800b0802-c4e6-409f-adbc-a985d1fca2a5 65483-895 HUMAN PRESCRIPTION DRUG LOTRONEX alosetron hydrochloride TABLET ORAL 20090209 NDA NDA021107 Prometheus Laboratories Inc. ALOSETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 65483-991_cec6bc7a-f20a-4216-8eb8-67fb1ba15ec7 65483-991 HUMAN PRESCRIPTION DRUG ZYLOPRIM allopurinol TABLET ORAL 19660819 NDA NDA016084 Prometheus Laboratories Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 65483-993_cec6bc7a-f20a-4216-8eb8-67fb1ba15ec7 65483-993 HUMAN PRESCRIPTION DRUG ZYLOPRIM allopurinol TABLET ORAL 19660819 NDA NDA016084 Prometheus Laboratories Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 65517-0001_15e7dc14-3948-485e-8eca-43b44957dcc7 65517-0001 HUMAN OTC DRUG Dukal Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20100501 OTC MONOGRAPH FINAL part333 Dukal Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 65517-0001_8bfa4ab0-9b92-4df1-8291-91c4bdf7e6ce 65517-0001 HUMAN OTC DRUG Dukal Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20100501 OTC MONOGRAPH FINAL part333 Dukal Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 65517-0002_31b45754-6dd1-4e84-8c2d-595464faf344 65517-0002 HUMAN OTC DRUG Dukal Sterile Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20000101 OTC MONOGRAPH FINAL part333 Dukal Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 65517-0002_8a28662e-463b-4d4d-972c-70ba441d4c11 65517-0002 HUMAN OTC DRUG Dukal Sterile Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20000101 OTC MONOGRAPH FINAL part333 Dukal Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 65517-0003_9c2999bd-af6f-4158-9143-75bd52edfb59 65517-0003 HUMAN OTC DRUG BZK Swab BENZALKONIUM CHLORIDE SWAB TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333A DUKAL CORPORATION BENZALKONIUM CHLORIDE .00133 mL/mL N 20181231 65517-0004_2e051637-982d-498c-a7f5-f55619eed706 65517-0004 HUMAN OTC DRUG BZK Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333A Dukal Corp BENZALKONIUM CHLORIDE 1.33 mg/mL N 20181231 65517-0005_2c6f0ec3-d960-4568-8645-fd5811aadc9f 65517-0005 HUMAN OTC DRUG DUKAL STING RELIEF PAD BENZOCAINE SWAB TOPICAL 20100601 OTC MONOGRAPH FINAL part348 Dukal Corporation BENZOCAINE; ISOPROPYL ALCOHOL 60; .6 mg/mL; mL/mL E 20171231 65517-0006_06a2d610-3da1-441f-844d-68de3084c9f7 65517-0006 HUMAN OTC DRUG Dukal Sterile Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20000101 OTC MONOGRAPH FINAL part333A Dukal Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 65517-0008_8a5253c8-1929-491d-aebc-a863452a4e89 65517-0008 HUMAN OTC DRUG Scrub Solution POVIDONE-IODINE SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Dukal Corporation POVIDONE-IODINE .9 mL/100mL E 20171231 65517-0009_853a4112-f20f-4bea-b94c-91aa5d5cf1e9 65517-0009 HUMAN OTC DRUG Prep Solution POVIDONE-IODINE SOLUTION TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Dukal Corporation POVIDONE-IODINE 1.2 mL/100mL E 20171231 65517-0010_8da692fb-6e8b-4550-ae94-c58b58c718c8 65517-0010 HUMAN OTC DRUG DUKAL POVIDONE-IODINE SWABSTICK POVIDONE-IODINE GEL TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Dukal Corporation POVIDONE-IODINE 1.2 mL/100mL N 20181231 65517-0011_b371219d-0e73-4f27-ad26-1b8ba2fa3090 65517-0011 HUMAN OTC DRUG OB Cleansing Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part310.545 Dukal Corporation BENZALKONIUM CHLORIDE .0021 mL/1.4mL N 20181231 65517-0012_a50cb3d8-b642-402f-8701-b4abde91965e 65517-0012 HUMAN OTC DRUG PHYSICIANS CARE STING RELIEF PAD BENZOCAINE SWAB TOPICAL 20100601 OTC MONOGRAPH FINAL part348 Dukal Corporation BENZOCAINE; ISOPROPYL ALCOHOL .06; .6 mL/mL; mL/mL N 20181231 65517-0013_80d20f92-8fa0-4f72-88ee-f800005963ee 65517-0013 HUMAN OTC DRUG Acme Home/Office/Auto Kit First Aid Kit KIT 20100501 OTC MONOGRAPH FINAL part333 Dukal Corporation N 20181231 65517-0014_e643840c-bc52-4280-ac01-b83fc6778d42 65517-0014 HUMAN OTC DRUG OB Cleansing Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20100101 OTC MONOGRAPH FINAL part333 Dukal Corporation BENZALKONIUM CHLORIDE .0021 mL/1.4mL N 20181231 65517-0015_7dad176d-bf6f-4c68-83ae-1e8706709f2c 65517-0015 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20100601 OTC MONOGRAPH FINAL part333 Dukal Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 65517-0016_7add14f5-e4a1-4f5a-9c5e-35213c43aaf4 65517-0016 HUMAN OTC DRUG Quick n Clean Antiseptic Hand Wipe Benzalkonium Chloride SWAB TOPICAL 20100601 OTC MONOGRAPH FINAL part333 Dukal Corporation BENZALKONIUM CHLORIDE .00186 mL/1.4mL N 20181231 65517-0026_51e97204-8280-4a48-be06-345718268412 65517-0026 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20120518 OTC MONOGRAPH FINAL part333A Dukal Corporation ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 65517-0027_abad83f9-9447-4782-befb-288f120e68a9 65517-0027 HUMAN OTC DRUG PVP Prep Povidone-Iodine SOLUTION TOPICAL 20120518 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation POVIDONE-IODINE 10 mL/100mL N 20181231 65517-0028_3d206a45-28fa-4fe9-80d3-206ba9dbac8f 65517-0028 HUMAN OTC DRUG PVP Scrub Povidone-Iodine SOLUTION TOPICAL 20120518 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation POVIDONE-IODINE 8 mL/100mL N 20181231 65517-0029_13e530a7-6c1f-4738-bd31-4bd63f22960a 65517-0029 HUMAN OTC DRUG PVP Prep Pad Povidone-Iodine SOLUTION TOPICAL 20120518 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation POVIDONE-IODINE 10 mL/100mL N 20181231 65517-0031_4f4d8607-f6c9-4409-99a4-b08c8550bb50 65517-0031 HUMAN OTC DRUG PVP-I Prep Pads foil-foil Povidone-iodine SWAB TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation POVIDONE-IODINE .9 g/100mL N 20191231 65517-0032_a451a2a0-564f-4cbc-8a41-b8ea2de6aece 65517-0032 HUMAN OTC DRUG PVP-I Pouch foil-foil Povidone-iodine SOLUTION TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation POVIDONE-IODINE .9 g/100mL N 20191231 65517-1000_01e3aa3f-7982-42e3-be41-b67131c9ea43 65517-1000 HUMAN OTC DRUG Dawnmist Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20120924 OTC MONOGRAPH FINAL part355 Dukal Corporation SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 65517-1001_da82961d-f51d-426e-a9a2-87339eec7d6e 65517-1001 HUMAN OTC DRUG DawnMist Antibacterial TRICLOSAN GEL TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation TRICLOSAN 3 mg/mL N 20181231 65517-1002_c06be3b9-76be-45d5-a5c6-10849a44a4ed 65517-1002 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 79 mg/mL N 20181231 65517-1003_6dc3e723-a810-4713-8052-705a5c9cd5ab 65517-1003 HUMAN OTC DRUG DawMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LOTION TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL N 20181231 65517-1004_d31778d1-d831-47f1-b22a-292e0aa27205 65517-1004 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL N 20181231 65517-1005_2b04f2bc-8fe5-4095-989f-377373c3f0c3 65517-1005 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL N 20181231 65517-1006_69c32aa0-b13f-4c1a-8092-5e92109df943 65517-1006 HUMAN OTC DRUG Dawnmist Deodorant TRICLOSAN SOAP TOPICAL 20130108 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation TRICLOSAN .25 g/100g E 20171231 65517-1007_b7c117bb-5422-4b01-8bcd-707dbbc6461f 65517-1007 HUMAN OTC DRUG DawnMist Alcohol Hand Sanitizer ALCOHOL GEL TOPICAL 20130114 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation ALCOHOL 700 mg/mL N 20181231 65517-1008_1242f838-95b1-4ad2-9fe5-e7b177165f66 65517-1008 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL N 20181231 65517-1009_f3fbcdcc-69f8-4229-ac8a-329d30308913 65517-1009 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL N 20181231 65517-1010_d12b8fc9-bcd7-437b-8ec5-d700c8feba38 65517-1010 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LOTION TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL N 20181231 65517-1011_6c0ab665-7193-4690-85da-048cbc527a7f 65517-1011 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE LOTION TOPICAL 20130110 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL N 20181231 65517-1012_7ead203c-98a5-450a-aa65-44d5d8f7b4e1 65517-1012 HUMAN OTC DRUG DawnMist Antibacterial TRICLOSAN GEL TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation TRICLOSAN 3 mg/mL N 20181231 65517-1013_fa0d9c17-3e9a-486d-81d5-a041770ed740 65517-1013 HUMAN OTC DRUG Dawnmist Deodorant TRICLOSAN SOAP TOPICAL 20130108 OTC MONOGRAPH NOT FINAL part333E Dukal Corporation TRICLOSAN .2 g/100g N 20181231 65517-1014_79426272-32ca-4127-96e3-21a43bb9b451 65517-1014 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20130502 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 45 mg/mL E 20171231 65517-1015_7f17de5d-cacd-4466-9293-7d3d3041a59c 65517-1015 HUMAN OTC DRUG DawnMist Antiperspirant Deodorant ALUMINUM CHLOROHYDRATE GEL TOPICAL 20130502 OTC MONOGRAPH FINAL part350 Dukal Corporation ALUMINUM CHLOROHYDRATE 150 mg/mL N 20181231 65517-1016_aa4d2677-6a8e-48ad-bd24-1142040f7a52 65517-1016 HUMAN OTC DRUG DawnMist Hypoallergenic 100 Percent Pure Petroleum PETROLATUM JELLY TOPICAL 20130502 OTC MONOGRAPH FINAL part347 Dukal Corporation PETROLATUM 100 g/100g N 20181231 65517-1017_cb033ae5-1f66-4182-9c0c-3a41e0597c5c 65517-1017 HUMAN OTC DRUG DawnMist Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20130606 OTC MONOGRAPH FINAL part355 Dukal Corporation SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 65517-1018_d5f76f24-05fe-44df-8cfe-4ffa7e6c2dd4 65517-1018 HUMAN OTC DRUG DawnMist Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20130606 OTC MONOGRAPH FINAL part355 Dukal Corporation SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 65517-1019_5a55cc5d-c039-4687-8738-55b0b78d6d5f 65517-1019 HUMAN OTC DRUG DawnMist Barrier Dimethicone CREAM TOPICAL 20130919 OTC MONOGRAPH FINAL part347 DUKAL Corporation DIMETHICONE .2 g/100g N 20181231 65517-2000_5ca1d990-9091-4c26-87d2-d5afc49ec0d3 65517-2000 HUMAN OTC DRUG Sodium fluoride Toothpaste CREAM ORAL 20131113 OTC MONOGRAPH FINAL part355 DUKAL CORPORATION SODIUM FLUORIDE .22 g/100g E 20171231 65517-2002_a3ca91a8-7786-48c9-ade6-8ea6a42942e0 65517-2002 HUMAN OTC DRUG DUKAL Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20140501 OTC MONOGRAPH FINAL part344 DUKAL Corporation ISOPROPYL ALCOHOL .7 g/mL N 20181231 65517-2003_2488648c-97b4-40c0-b655-ab6dee7431a9 65517-2003 HUMAN OTC DRUG Dukal Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20140617 OTC MONOGRAPH FINAL part344 Dukal Corporation ISOPROPYL ALCOHOL .7 g/mL N 20181231 65517-2017_f4fc92a0-26cf-4b51-ac0a-e33bf70ee966 65517-2017 HUMAN OTC DRUG DAWNMIST FLUORIDE SODIUM FLUORIDE PASTE DENTAL 20140117 OTC MONOGRAPH FINAL part355 DUKAL Corporation SODIUM FLUORIDE .22 g/100g E 20171231 65517-2018_b58c00b4-af53-4999-abae-902d74603532 65517-2018 HUMAN OTC DRUG DawnMist Fluoride Sodium Fluoride PASTE DENTAL 20140130 OTC MONOGRAPH FINAL part355 Dukal Corporation SODIUM FLUORIDE .76 g/100g E 20171231 65517-2020_cee47fec-a5d2-4b8c-9780-296a0a43b2b4 65517-2020 HUMAN OTC DRUG Dawnmist Petroleum Petrolatum JELLY TOPICAL 20141020 OTC MONOGRAPH FINAL part347 Dukal Corp PETROLATUM 100 g/100g N 20181231 65517-2021_fe50ed32-a69f-4a68-a9bb-a2b6683671aa 65517-2021 HUMAN OTC DRUG Dawnmist Moisture Barrier Petrolatum JELLY TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Dukal Corp PETROLATUM 98.3 g/100g N 20181231 65556-398_ccfed2e6-68df-4dcd-bb62-91de50e4485e 65556-398 HUMAN OTC DRUG Clearly Confident Miconazole Nitrate CREAM TOPICAL 20131217 OTC MONOGRAPH FINAL part333C Ganeden Biotech, Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 65567-001_60dd3dbb-1298-2bc2-e053-2a91aa0a9567 65567-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000420 NDA NDA205820 Central Montana Medical Facilities, Inc. OXYGEN 990 mL/L N 20181231 65573-001_c234ae36-5696-4ebe-bd85-60ba7f296bac 65573-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000101 NDA NDA205840 Home Equipment Associates, Inc. OXYGEN 990 mL/L N 20181231 65580-304_252c0bd2-a4ae-4d4a-88fe-7fc006340f21 65580-304 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080930 20180731 NDA NDA022104 Upstate Pharma, LLC VENLAFAXINE HYDROCHLORIDE 225 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65580-530_0c75fd34-ee7d-4be8-9a34-a9f291fef346 65580-530 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 20141101 ANDA ANDA085799 Upstate Pharma, LLC METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 65580-531_0c75fd34-ee7d-4be8-9a34-a9f291fef346 65580-531 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 20141101 ANDA ANDA086429 Upstate Pharma, LLC METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 65580-532_0c75fd34-ee7d-4be8-9a34-a9f291fef346 65580-532 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride methylphenidate hydrochloride TABLET ORAL 20141101 ANDA ANDA086428 Upstate Pharma, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 65580-594_4dc53ed3-ae7f-4eb2-b49f-23af7872935b 65580-594 HUMAN PRESCRIPTION DRUG Metadate ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA089601 Upstate Pharma, LLC METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 65580-643_5716d764-3691-4ebc-8e42-dbcac00f48a9 65580-643 HUMAN PRESCRIPTION DRUG metolazone metolazone TABLET ORAL 19731127 NDA AUTHORIZED GENERIC NDA017386 Upstate Pharma, LLC METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 65580-644_5716d764-3691-4ebc-8e42-dbcac00f48a9 65580-644 HUMAN PRESCRIPTION DRUG metolazone metolazone TABLET ORAL 19731127 NDA AUTHORIZED GENERIC NDA017386 Upstate Pharma, LLC METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 65580-645_5716d764-3691-4ebc-8e42-dbcac00f48a9 65580-645 HUMAN PRESCRIPTION DRUG metolazone metolazone TABLET ORAL 19731127 NDA AUTHORIZED GENERIC NDA017386 Upstate Pharma, LLC METOLAZONE 10 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 65582-100_4807a2bb-48ba-0325-e054-00144ff88e88 65582-100 HUMAN OTC DRUG Quintessence Q-Sunshade Leave In Hair Conditioner and Scalp Protectant SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE LIQUID TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part352 International Cosmeceuticals, Inc OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 5; 1 g/100mL; g/100mL; g/100mL N 20181231 65585-365_4ae384dc-b200-4fb6-aefe-c566853c83db 65585-365 HUMAN OTC DRUG WhiskCare 365 Chloroxylenol SOAP TOPICAL 20000331 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. CHLOROXYLENOL 10 mg/mL N 20181231 65585-371_5f3bf440-1eb5-4bfb-b754-415f04352278 65585-371 HUMAN OTC DRUG WhiskCare 371 Alcohol SPRAY, SUSPENSION TOPICAL 20080115 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. ALCOHOL 650 mL/L N 20181231 65585-373_b6c82da1-7212-421e-9c09-c90ad435c6a2 65585-373 HUMAN OTC DRUG WhiskCare 373 Alcohol SOAP TOPICAL 20080117 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. ALCOHOL 650 mL/L N 20181231 65585-375_53f63aad-bd09-4f1e-b15c-98924f0bf7cf 65585-375 HUMAN OTC DRUG WhiskCare 375 Alcohol GEL TOPICAL 20050601 OTC MONOGRAPH NOT FINAL part333A Whisk Products, Inc. ALCOHOL 600 mL/L N 20181231 65585-376_2500179f-23a1-4aba-92c7-2a87014326d9 65585-376 HUMAN OTC DRUG WhiskCare 375 Fragrance Free Instant Hand Sanitizer GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333 Whisk Products, Inc. ALCOHOL 600 mL/L N 20181231 65585-480_bca7da75-4a20-40fc-b3ae-9900fafc966c 65585-480 HUMAN OTC DRUG Alpha E-3 Alcohol SPRAY TOPICAL 20051219 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. ALCOHOL 600 mL/L N 20181231 65585-489_6261ac1e-1eb5-4ad3-a8e4-1f5560f5bc55 65585-489 HUMAN OTC DRUG Pretty Pump Hand Sanitizer Alcohol SPRAY TOPICAL 20011009 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. ALCOHOL 600 mL/L N 20181231 65585-494_03ee4490-3e18-4d59-86fb-27a94d8e3995 65585-494 HUMAN OTC DRUG Chem Clean Antibacterial Hand Chloroxylenol SOAP TOPICAL 20080103 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. CHLOROXYLENOL .75 g/100g N 20181231 65585-495_28b7ac10-813c-4527-aedf-2e24562297c7 65585-495 HUMAN OTC DRUG Alpha E-2 Benzalkonium Chloride SOAP TOPICAL 20080121 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 25 mg/mL N 20181231 65585-497_ebc7e0d1-c7a2-4a33-9985-3461017e255b 65585-497 HUMAN OTC DRUG Alpha Alcohol Free Foaming Instant Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20090526 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 65585-503_330325b3-3bed-43f0-88dd-21c36803ea5d 65585-503 HUMAN OTC DRUG AMP Instant Hand Sanitizer Hand Sanitizer SOAP TOPICAL 20091209 OTC MONOGRAPH NOT FINAL part333 Whisk Products, Inc. ALCOHOL 600 mL/L E 20171231 65585-508_f74366ee-ac69-4fd2-8e6b-e01cce16ee68 65585-508 HUMAN OTC DRUG SMJ Antibacterial Hand Chloroxylenol SOAP TOPICAL 20120105 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. CHLOROXYLENOL .75 g/100g N 20181231 65585-509_127fa410-10d5-48a9-9805-f70aaa9265dd 65585-509 HUMAN OTC DRUG WhiskCare 357 Benzalkonium Chloride SOAP TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 65585-510_095523de-0d15-4ee8-b5cf-f57642342c41 65585-510 HUMAN OTC DRUG Alpha Foaming E-2 Benzalkonium Chloride SOAP TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 65585-511_6e7c77e7-a1a7-45ce-969a-03c06455d0ab 65585-511 HUMAN OTC DRUG Hand-Giene E-2 Benzalkonium Chloride SOAP TOPICAL 20121106 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 65585-512_c39afd34-2977-4292-b55f-5ce28eb9e9d9 65585-512 HUMAN OTC DRUG Safe Hands U-357 Benzalkonium Chloride SOAP TOPICAL 20130626 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 65585-515_da168167-3aa6-4352-bb1f-3d14cdd51069 65585-515 HUMAN OTC DRUG North Woods Germ Stuff Benzalkonium Chloride SOAP TOPICAL 20140702 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 25 mg/mL N 20181231 65585-516_7b458425-fc06-4fbd-b395-90abb5d14801 65585-516 HUMAN OTC DRUG Algonquin HanClean II Benzalkonium Chloride SOAP TOPICAL 20160404 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 25 mg/mL N 20181231 65585-517_ce41f5f2-30d1-4916-a01c-186983c70497 65585-517 HUMAN OTC DRUG Algonquin FoamSan Alcohol SOAP TOPICAL 20160404 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. ALCOHOL 650 mL/L N 20181231 65585-518_ad19a95f-7c92-4f3d-947c-5f0fe2bdb16b 65585-518 HUMAN OTC DRUG Algonquin HanClean Foam Benzalkonium Chloride SOAP TOPICAL 20160404 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 65585-519_27608566-f7d4-4549-b0ca-b62474f7bf34 65585-519 HUMAN OTC DRUG Algonquin HanSan Alcohol SOAP TOPICAL 20160404 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. ALCOHOL 600 mL/L N 20181231 65585-555_28cd3934-459b-48da-90dc-e5411bafe66f 65585-555 HUMAN OTC DRUG WhiskCare 355 Benzalkonium Chloride SOAP TOPICAL 20070920 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 25 mg/mL N 20181231 65585-562_ca844a8e-5051-4bf2-b042-992cd4312225 65585-562 HUMAN OTC DRUG WhiskCare 362 Chloroxylenol SOAP TOPICAL 20060123 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. CHLOROXYLENOL 7.5 mg/mL N 20181231 65585-568_a939db1b-29f8-43e7-8d74-ecec8a53c5cf 65585-568 HUMAN OTC DRUG WhiskCare 367 Chloroxylenol SOAP TOPICAL 20071206 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. CHLOROXYLENOL 7.5 mg/mL N 20181231 65585-577_e8d0b80f-e524-43c1-b368-fb81b5722829 65585-577 HUMAN OTC DRUG WhiskCare 377 Benzalkonium Chloride SOAP TOPICAL 20051012 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 65585-578_9c016c20-3015-41ef-b6bc-6a1aca5110c3 65585-578 HUMAN OTC DRUG WhiskCare 377 Free Benzalkonium Chloride SOAP TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 65585-579_db22b61d-c255-4267-809f-ce312be7bf65 65585-579 HUMAN OTC DRUG Antibacterial Skin Cleanser 82 Chloroxylenol SOAP TOPICAL 20160920 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. CHLOROXYLENOL 10 mg/mL N 20181231 65585-580_af3187b0-df0e-49c4-bd74-e8ac00501063 65585-580 HUMAN OTC DRUG AP HanSan Alcohol SPRAY TOPICAL 20161024 OTC MONOGRAPH NOT FINAL part333E WhiskProducts, Inc. ALCOHOL 600 mL/L N 20181231 65585-581_05344ff4-c199-442b-a525-14c7bc093e89 65585-581 HUMAN OTC DRUG E-2 Cleanser Sanitizer 86 Benzalkonium Chloride SOAP TOPICAL 20170525 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 25 mg/mL N 20181231 65585-582_743bd0d6-eacf-4d09-9dad-030a2c0577df 65585-582 HUMAN OTC DRUG Jade Antibacterial Hand Chloroxylenol SOAP TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. CHLOROXYLENOL .75 g/100mL N 20181231 65585-583_30179745-762d-4fc9-bd97-7f53b7427dfc 65585-583 HUMAN OTC DRUG WhiskCare 387 Benzalkonium Chloride SOAP TOPICAL 20170831 OTC MONOGRAPH NOT FINAL part333E Whisk Products, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 65588-2210_7b3a0d7b-acdb-4a98-a1e1-4319bfc754e6 65588-2210 HUMAN OTC DRUG Maximum-H HYDROCORTISONE CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part348 New GPC, Inc. HYDROCORTISONE 1 g/100g E 20171231 65588-2230_b04435ae-1f67-4bc6-ad07-eceb51ea3d37 65588-2230 HUMAN OTC DRUG Medisilke Night HYDROQUINONE CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part358A New GPC, Inc. HYDROQUINONE 2 g/100g E 20171231 65597-101_104cf4d9-01c1-4016-9116-219c8e745b1f 65597-101 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Daiichi Sankyo Inc. OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 65597-103_104cf4d9-01c1-4016-9116-219c8e745b1f 65597-103 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Daiichi Sankyo Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 65597-104_104cf4d9-01c1-4016-9116-219c8e745b1f 65597-104 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Daiichi Sankyo Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 65597-105_187b1ef2-ef83-4a34-9096-9374babf3a93 65597-105 HUMAN PRESCRIPTION DRUG Benicar HCT olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Daiichi Sankyo Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 65597-106_187b1ef2-ef83-4a34-9096-9374babf3a93 65597-106 HUMAN PRESCRIPTION DRUG Benicar HCT olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Daiichi Sankyo Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 65597-107_187b1ef2-ef83-4a34-9096-9374babf3a93 65597-107 HUMAN PRESCRIPTION DRUG Benicar HCT olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20030605 NDA NDA021532 Daiichi Sankyo Inc. OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 65597-110_9a4d64ae-88da-411d-9e34-40d95fe6093f 65597-110 HUMAN PRESCRIPTION DRUG Azor amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20070926 NDA NDA022100 Daiichi Sankyo Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 65597-111_9a4d64ae-88da-411d-9e34-40d95fe6093f 65597-111 HUMAN PRESCRIPTION DRUG Azor amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20070926 NDA NDA022100 Daiichi Sankyo Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 65597-112_9a4d64ae-88da-411d-9e34-40d95fe6093f 65597-112 HUMAN PRESCRIPTION DRUG Azor amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20070926 NDA NDA022100 Daiichi Sankyo Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 65597-113_9a4d64ae-88da-411d-9e34-40d95fe6093f 65597-113 HUMAN PRESCRIPTION DRUG Azor amlodipine besylate and olmesartan medoxomil TABLET, FILM COATED ORAL 20070926 NDA NDA022100 Daiichi Sankyo Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 65597-114_f923f7dc-920d-4877-99d6-6e78e4bc2e3c 65597-114 HUMAN PRESCRIPTION DRUG Tribenzor olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20100731 NDA NDA200175 Daiichi Sankyo Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 20; 5; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 65597-115_f923f7dc-920d-4877-99d6-6e78e4bc2e3c 65597-115 HUMAN PRESCRIPTION DRUG Tribenzor olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20100731 NDA NDA200175 Daiichi Sankyo Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 5; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 65597-116_f923f7dc-920d-4877-99d6-6e78e4bc2e3c 65597-116 HUMAN PRESCRIPTION DRUG Tribenzor olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20100731 NDA NDA200175 Daiichi Sankyo Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 5; 25 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 65597-117_f923f7dc-920d-4877-99d6-6e78e4bc2e3c 65597-117 HUMAN PRESCRIPTION DRUG Tribenzor olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20100731 NDA NDA200175 Daiichi Sankyo Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 10; 12.5 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 65597-118_f923f7dc-920d-4877-99d6-6e78e4bc2e3c 65597-118 HUMAN PRESCRIPTION DRUG Tribenzor olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide TABLET, FILM COATED ORAL 20100731 NDA NDA200175 Daiichi Sankyo Inc. OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE 40; 10; 25 mg/1; mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 65597-201_0b27d664-baa2-4208-ab84-2b8735daceec 65597-201 HUMAN PRESCRIPTION DRUG SAVAYSA EDOXABAN TOSYLATE TABLET, FILM COATED ORAL 20150112 NDA NDA206316 Daiichi Sankyo, Inc. EDOXABAN TOSYLATE 15 mg/1 Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 65597-202_0b27d664-baa2-4208-ab84-2b8735daceec 65597-202 HUMAN PRESCRIPTION DRUG SAVAYSA EDOXABAN TOSYLATE TABLET, FILM COATED ORAL 20150112 NDA NDA206316 Daiichi Sankyo, Inc. EDOXABAN TOSYLATE 30 mg/1 Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 65597-203_0b27d664-baa2-4208-ab84-2b8735daceec 65597-203 HUMAN PRESCRIPTION DRUG SAVAYSA EDOXABAN TOSYLATE TABLET, FILM COATED ORAL 20150112 NDA NDA206316 Daiichi Sankyo, Inc. EDOXABAN TOSYLATE 60 mg/1 Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 65597-301_2ca27116-ccf7-4bc2-b0da-5fcf917e8409 65597-301 HUMAN PRESCRIPTION DRUG MorphaBond ER morphine sulfate TABLET, EXTENDED RELEASE ORAL 20170302 NDA NDA206544 Daiichi Sankyo Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 65597-302_2ca27116-ccf7-4bc2-b0da-5fcf917e8409 65597-302 HUMAN PRESCRIPTION DRUG MorphaBond ER morphine sulfate TABLET, EXTENDED RELEASE ORAL 20170302 NDA NDA206544 Daiichi Sankyo Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 65597-303_2ca27116-ccf7-4bc2-b0da-5fcf917e8409 65597-303 HUMAN PRESCRIPTION DRUG MorphaBond ER morphine sulfate TABLET, EXTENDED RELEASE ORAL 20170302 NDA NDA206544 Daiichi Sankyo Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 65597-304_2ca27116-ccf7-4bc2-b0da-5fcf917e8409 65597-304 HUMAN PRESCRIPTION DRUG MorphaBond ER morphine sulfate TABLET, EXTENDED RELEASE ORAL 20170302 NDA NDA206544 Daiichi Sankyo Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 65597-501_9f506d02-f90e-4748-9de6-78bfe3c26e4f 65597-501 HUMAN PRESCRIPTION DRUG Roxybond oxycodone hydrochloride TABLET, COATED ORAL 20170420 NDA NDA209777 Daiichi Sankyo Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 65597-502_9f506d02-f90e-4748-9de6-78bfe3c26e4f 65597-502 HUMAN PRESCRIPTION DRUG Roxybond oxycodone hydrochloride TABLET, COATED ORAL 20170420 NDA NDA209777 Daiichi Sankyo Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 65597-503_9f506d02-f90e-4748-9de6-78bfe3c26e4f 65597-503 HUMAN PRESCRIPTION DRUG Roxybond oxycodone hydrochloride TABLET, COATED ORAL 20170420 NDA NDA209777 Daiichi Sankyo Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 65597-701_99a56e58-7466-4bd0-82bc-4a09e14b7a43 65597-701 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride TABLET, FILM COATED ORAL 20000901 NDA NDA021176 Daiichi Sankyo, Inc. COLESEVELAM HYDROCHLORIDE 625 mg/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 65597-902_99a56e58-7466-4bd0-82bc-4a09e14b7a43 65597-902 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride FOR SUSPENSION ORAL 20100101 NDA NDA022362 Daiichi Sankyo, Inc. COLESEVELAM HYDROCHLORIDE 3.75 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 65597-903_99a56e58-7466-4bd0-82bc-4a09e14b7a43 65597-903 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride FOR SUSPENSION ORAL 20100101 NDA NDA022362 Daiichi Sankyo, Inc. COLESEVELAM HYDROCHLORIDE 1.875 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 65601-170_6615baf1-1a0e-4d3c-b6a2-3bc261cad0d3 65601-170 HUMAN OTC DRUG Direct Effect E-2 Benzalkonium Chloride SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 25 mg/mL E 20171231 65601-700_0964fc71-9c42-4a8c-8bca-03899cb9c019 65601-700 HUMAN OTC DRUG Alcohol Free Foaming Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 65601-701_5f68cb92-fc1c-4c89-8bc8-b84a2342c50f 65601-701 HUMAN OTC DRUG Alcohol Foaming Hand Sanitizer Alcohol SOAP TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. ALCOHOL .62 mL/mL E 20171231 65601-702_1acf4b4b-6781-4622-b749-d38acabcb041 65601-702 HUMAN OTC DRUG E2 Antibacterial Foaming Skin Cleanser Benzalkonium Chloride SOAP TOPICAL 20160915 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 65601-703_e1ab176c-fab5-4c4c-a88b-9defe3078e6e 65601-703 HUMAN OTC DRUG Ultra Blue Antibacterial Foaming Skin Cleanser Tricolsan SOAP TOPICAL 20160915 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. TRICLOSAN 6 1/mL E 20171231 65601-704_a1f853f9-cd6a-465b-ba2d-1f68f9e32a40 65601-704 HUMAN OTC DRUG Antibacterial Foaming Skin Cleanser Tricolsan SOAP TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. TRICLOSAN 3 mg/mL E 20171231 65601-705_e21717e4-3057-4d67-bf62-e2e4857fba68 65601-705 HUMAN OTC DRUG Ultra Mild Antibacterial Skin Cleanser Tricolsan SOAP TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. TRICLOSAN 3 mg/mL E 20171231 65601-706_093fd016-ed96-40c0-8e40-5d0772e692f4 65601-706 HUMAN OTC DRUG Premium Antibacterial Skin Cleanser Chloroxylenol SOAP TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. CHLOROXYLENOL 5 mg/mL E 20171231 65601-707_639c1226-b59b-4f66-a085-56454a48d52e 65601-707 HUMAN OTC DRUG Green Earth Alcohol Gel Sanitizer Alcohol SOAP TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. ALCOHOL .62 mL/mL E 20171231 65601-708_b14712d5-4813-4177-8b1e-e07ddeb73795 65601-708 HUMAN OTC DRUG Antibacterial Skin Cleanser Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. CHLOROXYLENOL 3.75 mg/mL E 20171231 65601-709_a61bff12-ce41-4b4f-8c01-12517899e4f1 65601-709 HUMAN OTC DRUG Antibacterial Foaming Skin Cleanser Benzalkonium Chloride SOAP TOPICAL 20170719 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 65601-710_46cd6a07-83f4-4da6-8827-bae7b54e840a 65601-710 HUMAN OTC DRUG Ultra Mild Antibacterial Skin Cleanser Benzalkonium Chloride SOAP TOPICAL 20170713 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 65601-717_0ff8d53e-36b5-4a7d-922f-2cdf41d848f3 65601-717 HUMAN OTC DRUG Clario E2 Antibacterial Foaming Skin Cleanser Benzalkonium Chloride SOAP TOPICAL 20140117 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 65601-736_f89eece0-4cb8-4e75-ad8a-cbbee0bb29df 65601-736 HUMAN OTC DRUG Winning Hands Premium Antibacterial Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. CHLOROXYLENOL 5 mg/mL E 20171231 65601-741_4d8e6fa8-f31f-41fa-80fe-a0711a4e9a55 65601-741 HUMAN OTC DRUG Triton AB-741 Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. CHLOROXYLENOL 3.75 mg/mL E 20171231 65601-744_51ea0341-50b0-4c10-82cd-a2143a523030 65601-744 HUMAN OTC DRUG Winning Hands Antibacterial Tricolsan SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. TRICLOSAN 3 mg/mL E 20171231 65601-751_d7c89862-7daf-4ca7-97a4-b2e2ad0079f5 65601-751 HUMAN OTC DRUG Winning Hands Foaming Antibacterial Tricolsan SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. TRICLOSAN 3 mg/mL E 20171231 65601-752_3587faf3-4964-443b-b7b3-c88cdb1e360c 65601-752 HUMAN OTC DRUG Winning Hands Alcohol Free Benzalkonium Chloride SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 65601-755_05fc7690-7e18-49e4-9986-ad7870a416c9 65601-755 HUMAN OTC DRUG Winning Hands Alcohol Foaming Alcohol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. ALCOHOL .7 mL/mL E 20171231 65601-757_95d7bcdc-1e11-4961-9388-390af47d4f63 65601-757 HUMAN OTC DRUG Clario Foaming Antibacterial Skin Cleanser Tricolsan SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. TRICLOSAN 3 mg/mL E 20171231 65601-759_de3bb88d-a1df-4b6e-9750-63dfaf764694 65601-759 HUMAN OTC DRUG Clario Ultra Blue Antibacterial Foaming Skin Cleanser Tricolsan SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. TRICLOSAN 6 mg/mL E 20171231 65601-765_5aa8dc30-f8f4-4abf-a91b-06f7416aaeb0 65601-765 HUMAN OTC DRUG Knuckle Under Medicated Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. CHLOROXYLENOL 5 mg/mL E 20171231 65601-772_2c004352-27a7-4ed4-8c40-01b52a00882d 65601-772 HUMAN OTC DRUG Winning Hands Hand Sanitizer Alcohol GEL TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. ALCOHOL .62 mL/mL E 20171231 65601-774_f2108a51-ec9b-460f-b2b9-330fea934af9 65601-774 HUMAN OTC DRUG Clario Foaming Alcohol Instant Hand Sanitizer Alcohol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. ALCOHOL .7 mL/mL E 20171231 65601-776_66d92578-6843-452a-bca7-467819633f0b 65601-776 HUMAN OTC DRUG Clario Instant Hand Sanitizer Alcohol SOAP TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. ALCOHOL .62 mL/mL E 20171231 65601-777_ff82b5b8-afe1-4742-afae-e15c4c2ce942 65601-777 HUMAN OTC DRUG Triton HS-777 Alcohol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333E Betco Corporation, Ltd. ALCOHOL .7 mL/mL E 20171231 65601-778_c196c001-1e20-4895-8d12-adde20ca448d 65601-778 HUMAN OTC DRUG Clario Free Foaming Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 65601-779_2fc27804-8a8d-4c72-83d6-8c374552fa1f 65601-779 HUMAN OTC DRUG E3 Alcohol Free Foaming Sanitizer Benzalkonium Chloride SOAP TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 1 mg/mL E 20171231 65601-782_41a73868-49cb-477f-be81-8f8e149089af 65601-782 HUMAN OTC DRUG Triton E2-782 Benzalkonium Chloride SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Betco Corporation, Ltd. BENZALKONIUM CHLORIDE 25 mg/mL E 20171231 65603-100_a015012b-e1b5-4498-88e7-7e2d454a4697 65603-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20011020 NDA NDA205840 Arkansas Welding Supply, Inc. OXYGEN 992 mL/L N 20181231 65616-001_bf638664-6afb-4d55-96e1-16682c346082 65616-001 HUMAN OTC DRUG Sterillium Rub Surgical Hand Antiseptic LIQUID TOPICAL 20030501 OTC MONOGRAPH NOT FINAL part333 Bode Chemie Hamburg ALCOHOL 80 mL/100mL E 20171231 65616-003_3af51336-7b25-4dbd-9b05-72879520e736 65616-003 HUMAN OTC DRUG Sterillium Comfort Alcohol GEL TOPICAL 20070401 OTC MONOGRAPH NOT FINAL part333A BODE Chemie GmbH ALCOHOL 85 mL/100mL N 20181231 65616-004_9ae65df6-85d6-4d2a-96da-a0b5af30567f 65616-004 HUMAN OTC DRUG Sterillium Rub Fragrance Free Alcohol LIQUID TOPICAL 20120328 OTC MONOGRAPH NOT FINAL part333A BODE Chemie GmbH ALCOHOL 85 mL/100mL N 20181231 65616-005_022dd4ac-ba10-45ff-bc6a-d4b34f4de8fe 65616-005 HUMAN OTC DRUG Sterillium Med Alcohol LIQUID TOPICAL 20120326 OTC MONOGRAPH NOT FINAL part333A BODE Chemie GmbH ALCOHOL 85 mL/100mL N 20181231 65626-017_221dc3e7-e913-4fbe-95c8-388eaa39c3a6 65626-017 HUMAN OTC DRUG Hand Essentials Antibacterial triclosan SOAP TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333E HU-FRIEDY MFG. CO., INC. TRICLOSAN .5 mg/100mL E 20171231 65626-161_d102e331-fd3f-46ca-9382-2f103afbc853 65626-161 HUMAN OTC DRUG Hand Essentials Skin Repair dimethicone CREAM TOPICAL 20101001 OTC MONOGRAPH FINAL part347 HU-FRIEDY MFG. CO., INC. DIMETHICONE 1.5 mL/100mL N 20181231 65626-206_02992321-9f9b-4e0d-9dfd-136c1f6843a3 65626-206 HUMAN OTC DRUG Hand Essentials Instant Hand Antiseptic ethyl alcohol GEL TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333E Hu-Friedy Mfg. Co., Inc. ALCOHOL 70 mL/100mL N 20181231 65643-010_af1e5df5-7d6d-4052-b2c5-61f9507ec50e 65643-010 HUMAN OTC DRUG FlexGen Menthol CREAM TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part348 Lifetech Resources, LLC MENTHOL 12.5 mg/g E 20171231 65643-165_055c09fd-3a13-46c5-8add-2a03abf3cd2e 65643-165 HUMAN OTC DRUG Desert Bambu Facial Sunscreen SPF 30 Octinoxate, Octocrylene, Octisalate, and Zinc Oxide CREAM TOPICAL 20080301 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; ZINC OXIDE 74.025; 59.22; 49.35; 2.902 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65643-166_55b6204f-1f50-4a66-ae83-6d6ad052c70f 65643-166 HUMAN OTC DRUG Desert Bambu Tanning SPF 15 Octinoxate and Avobenzone LOTION TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; AVOBENZONE 75; 20 mg/mL; mg/mL E 20171231 65643-173_542926b1-af1c-409e-9548-bda3ae2c3e25 65643-173 HUMAN OTC DRUG Desert Bambu Lip Balm SPF 15 Octinoxate, Oxybenzone, and Octisalate OINTMENT TOPICAL 20080501 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OXYBENZONE; OCTISALATE 66.825; 26.73; 35.64 mg/mL; mg/mL; mg/mL E 20171231 65643-325_113e3223-7d36-475b-84cd-ddba585e2936 65643-325 HUMAN OTC DRUG Bellagio Sunscreen For Face SPF 30 Octinoxate, Octocrylene, Octisalate, and Zinc Oxide LOTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; ZINC OXIDE 74.25; 59.4; 49.5; 29.106 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65643-326_8dcb682e-c6d8-451e-9713-8f1dade7df95 65643-326 HUMAN OTC DRUG Bellagio Sunscreen SPF 15 Octinoxate and Avobenzone LOTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; AVOBENZONE 76.8; 20.48 mg/mL; mg/mL E 20171231 65643-327_55008b6a-5c98-42b9-8acf-cbddd81e76d6 65643-327 HUMAN OTC DRUG Bellagio Sunscreen SPF 8 Octinoxate and Oxybenzone LOTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OXYBENZONE 49.7; 29.82 mg/mL; mg/mL E 20171231 65643-329_d9299e47-aa16-419c-b4cf-deb1f886170c 65643-329 HUMAN OTC DRUG Bellagio Sunscreen SPF 30 Octinoxate, Octocrylene, Oxybenzone, and Octisalate SPRAY TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OCTOCRYLENE; OXYBENZONE; OCTISALATE 68.32; 68.32; 58.56; 48.8 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65643-330_591dc37e-4d2b-4421-bd66-a441ad567241 65643-330 HUMAN OTC DRUG Bellagio Sunscreen SPF 15 Octinoxate, Avobenzone, and Octisalate SPRAY TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; AVOBENZONE; OCTISALATE 71.85; 19.16; 47.9 mg/mL; mg/mL; mg/mL E 20171231 65643-331_c42de5d9-6610-4aa8-8f4b-e7c058432a29 65643-331 HUMAN OTC DRUG Bellagio Dark Tanning SPF 2 Octinoxate and Oxybenzone SPRAY TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OXYBENZONE 9.49; 9.49 mg/mL; mg/mL E 20171231 65643-333_a157f263-e955-493b-a5ea-1bd78cc82e04 65643-333 HUMAN OTC DRUG Bellagio Lip Moisturizer SPF 15 Octinoxate, Octisalate, and Oxybenzone OINTMENT TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OCTISALATE; OXYBENZONE 64.26; 36.72; 32.13 mg/g; mg/g; mg/g E 20171231 65643-334_c2265afb-8543-49d2-9ef8-49204e60d967 65643-334 HUMAN OTC DRUG Bellagio Sunscreen SPF 30 Homosalate, Octinoxate, Octocrylene, and Oxybenzone LOTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 100.7; 70.49; 65.455; 55.385 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65643-335_6ff19afa-8f16-4d33-99b6-04d8530c48a1 65643-335 HUMAN OTC DRUG Bellagio Sunscreen SPF 45 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Zinc Oxide LOTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 143.22; 66.495; 51.15; 51.15; 28.03 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65643-336_7546ca55-e729-47ca-9130-f27f71e32c80 65643-336 HUMAN OTC DRUG Bellagio Childrens Sunscreen SPF 45 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Zinc Oxide LOTION TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 141.904; 65.884; 50.68; 50.68; 27.773 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65643-406_6f87d664-53dd-4573-ac1e-14191aecfde5 65643-406 HUMAN OTC DRUG Celadrin Menthol CREAM TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part348 Lifetech Resources, LLC MENTHOL 12.5 mg/g E 20171231 65643-415_390610ed-5b67-4203-8afa-3ac93856f989 65643-415 HUMAN OTC DRUG Desert Bambu Dark Tanning SPF 2 Octinoxate and Oxybenzone SPRAY TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OXYBENZONE 9.49; 9.49 mg/mL; mg/mL E 20171231 65643-416_fca2fd30-7f08-49a4-95a2-bdcb018273a4 65643-416 HUMAN OTC DRUG Desert Bambu Tanning SPF 6 Octinoxate and Avobenzone SPRAY TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; AVOBENZONE 37.88; 18.94 mg/mL; mg/mL E 20171231 65643-417_7715c7f4-32b2-4bff-95a5-36aa69a4473d 65643-417 HUMAN OTC DRUG Desert Bambu Tanning SPF 15 Octinoxate, Avobenzone, and Octisalate SPRAY TOPICAL 20080501 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; AVOBENZONE; OCTISALATE 71.55; 19.08; 47.7 mg/mL; mg/mL; mg/mL E 20171231 65643-418_d1ed0a37-1189-4869-9e06-e4f4e95e4f78 65643-418 HUMAN OTC DRUG Desert Bambu Sunscreen SPF 15 Octinoxate and Avobenzone LOTION TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; AVOBENZONE 75; 20 mg/mL; mg/mL E 20171231 65643-419_fed50f59-cba9-40ff-91fa-01a0c7f6630c 65643-419 HUMAN OTC DRUG Desert Bambu Sunscreen SPF 30 Octinoxate, Octocrylene, Oxybenzone, and Titanium Dioxide LOTION TOPICAL 20080401 OTC MONOGRAPH NOT FINAL part352 Lifetech Resources, LLC OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 73.5; 68.25; 57.75; 47.25 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 65649-101_b78e25da-938c-40b6-81d1-3529e447894e 65649-101 HUMAN PRESCRIPTION DRUG Colazal balsalazide disodium CAPSULE ORAL 20000718 NDA AUTHORIZED GENERIC NDA020610 Salix Pharmaceuticals, Inc BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 65649-102_88815992-18ab-4ef2-a51d-b03749a6a0b4 65649-102 HUMAN PRESCRIPTION DRUG GIAZO balsalazide disodium TABLET, FILM COATED ORAL 20120203 NDA NDA022205 Salix Pharmaceuticals, Inc BALSALAZIDE DISODIUM 1.1 g/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 65649-103_45105af2-1096-4b2b-a6b7-10643f9fe93c 65649-103 HUMAN PRESCRIPTION DRUG APRISO mesalamine CAPSULE, EXTENDED RELEASE ORAL 20081031 NDA NDA022301 Salix Pharmaceuticals, Inc. MESALAMINE 375 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 65649-150_fdf0d0c8-f4da-406e-8d91-5f6803e2cc49 65649-150 HUMAN PRESCRIPTION DRUG Relistor Methylnaltrexone bromide TABLET ORAL 20080801 NDA NDA208271 Salix Pharmaceuticals, Inc. METHYLNALTREXONE BROMIDE 150 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA],Quaternary Ammonium Compounds [Chemical/Ingredient] N 20191231 65649-201_7a33061d-935f-4b5b-b61e-7c007f4db321 65649-201 HUMAN PRESCRIPTION DRUG MoviPrep POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE KIT 20061001 NDA NDA021881 Salix Pharmaceuticals, Inc. N 20181231 65649-211_494420bd-50df-47f5-a243-116042be6042 65649-211 HUMAN PRESCRIPTION DRUG PEPCID FAMOTIDINE POWDER, FOR SUSPENSION ORAL 19870601 NDA NDA019527 Salix Pharmaceuticals, Inc. FAMOTIDINE 40 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 65649-231_5f49e65c-dc8b-35f0-e053-2991aa0ae99f 65649-231 HUMAN PRESCRIPTION DRUG Azasan Azathioprine TABLET ORAL 20030401 ANDA ANDA075252 Salix Pharmaceuticals AZATHIOPRINE 75 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 65649-241_5f49e65c-dc8b-35f0-e053-2991aa0ae99f 65649-241 HUMAN PRESCRIPTION DRUG Azasan Azathioprine TABLET ORAL 20030401 ANDA ANDA075252 Salix Pharmaceuticals AZATHIOPRINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 65649-301_d8ce6203-4294-445c-a86b-43ee5f2572df 65649-301 HUMAN PRESCRIPTION DRUG XIFAXAN rifaximin TABLET ORAL 20040725 NDA NDA021361 Salix Pharmaceuticals, Inc. RIFAXIMIN 200 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20191231 65649-303_d8ce6203-4294-445c-a86b-43ee5f2572df 65649-303 HUMAN PRESCRIPTION DRUG XIFAXAN rifaximin TABLET ORAL 20100501 NDA NDA021361 Salix Pharmaceuticals, Inc. RIFAXIMIN 550 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20191231 65649-311_5431439b-abd5-4bc3-9873-8510f1ab9938 65649-311 HUMAN PRESCRIPTION DRUG DIURIL CHLOROTHIAZIDE SUSPENSION ORAL 19620215 NDA NDA011870 Salix Pharmaceuticals, Inc CHLOROTHIAZIDE 250 mg/5mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 65649-401_8adc60c5-18df-46fe-b911-40f264660195 65649-401 HUMAN PRESCRIPTION DRUG Anusol HC hydrocortisone CREAM TOPICAL 19840606 ANDA ANDA088250 Salix Pharmaceuticals, Inc HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 65649-411_81345f02-66e4-47f7-bbdb-8928f3f98eb4 65649-411 HUMAN PRESCRIPTION DRUG Anusol HC HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20040601 UNAPPROVED DRUG OTHER Salix Pharmaceuticals, Inc HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 65649-501_a4f7333b-2694-420b-9e97-958110ac0646 65649-501 HUMAN PRESCRIPTION DRUG Proctocort HYDROCORTISONE CREAM TOPICAL 20040601 ANDA ANDA080706 Salix Pharmaceuticals, Inc HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 65649-511_c09b0ff0-c9cd-4850-b071-9a6bc5098d04 65649-511 HUMAN PRESCRIPTION DRUG Proctocort HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20040601 UNAPPROVED DRUG OTHER Salix Pharmaceuticals, Inc HYDROCORTISONE ACETATE 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 65649-551_fdf0d0c8-f4da-406e-8d91-5f6803e2cc49 65649-551 HUMAN PRESCRIPTION DRUG Relistor Methylnaltrexone bromide INJECTION, SOLUTION SUBCUTANEOUS 20080424 NDA NDA021964 Salix Pharmaceuticals, Inc. METHYLNALTREXONE BROMIDE 12 mg/.6mL Opioid Antagonist [EPC],Opioid Antagonists [MoA],Quaternary Ammonium Compounds [Chemical/Ingredient] N 20191231 65649-552_fdf0d0c8-f4da-406e-8d91-5f6803e2cc49 65649-552 HUMAN PRESCRIPTION DRUG Relistor Methylnaltrexone bromide INJECTION, SOLUTION SUBCUTANEOUS 20080424 NDA NDA021964 Salix Pharmaceuticals, Inc. METHYLNALTREXONE BROMIDE 8 mg/.4mL Opioid Antagonist [EPC],Opioid Antagonists [MoA],Quaternary Ammonium Compounds [Chemical/Ingredient] N 20191231 65649-651_6b21dc09-e744-47ec-82eb-aef0aef78ce7 65649-651 HUMAN PRESCRIPTION DRUG Uceris budesonide AEROSOL, FOAM RECTAL 20141201 NDA NDA205613 Salix Pharmaceuticals, Inc. BUDESONIDE 28 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 65649-701_6c2e9f26-da54-408a-9b2e-e687b1aebcb1 65649-701 HUMAN PRESCRIPTION DRUG OsmoPrep SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUS TABLET ORAL 20060515 NDA NDA021892 Salix Pharmaceuticals, Inc. SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 1.102; .398 g/1; g/1 N 20181231 65663-019_2561b68e-e638-4a1f-9030-e5db72ebca4e 65663-019 HUMAN OTC DRUG Bodycology white gardenia anti-bacterial scrubbing hand soap Triclosan LIQUID TOPICAL 20090721 OTC MONOGRAPH NOT FINAL part333 American Blending and Filling TRICLOSAN .3 mL/100mL E 20171231 65663-020_e6185362-4152-4722-95c6-0dc6903027de 65663-020 HUMAN OTC DRUG Bodycology white gardenia anti-bacterial foaming hand soap Triclosan LIQUID TOPICAL 20090721 OTC MONOGRAPH NOT FINAL part333 American Blending and Filling TRICLOSAN .3 mL/100mL E 20171231 65663-023_52f8212f-1cda-4b32-ae59-723820957345 65663-023 HUMAN OTC DRUG Bodycology Peppermint Sugar anti-bacterial scrubbing hand soap Triclosan LIQUID TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part333 American Blending and Filling TRICLOSAN .3 mL/100mL E 20171231 65663-024_cdd5dde6-c64c-4ef0-b2b9-00b6420e9ea5 65663-024 HUMAN OTC DRUG Bodycology Sparkling Cranberry anti-bacterial scrubbing hand soap Triclosan LIQUID TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part333 American Blending and Filling TRICLOSAN .3 mL/100mL E 20171231 65676-0001_586fade3-e119-479c-8aa4-8c233ded6c3a 65676-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000329 UNAPPROVED MEDICAL GAS KC's Medical Home Care Supplies, Inc. OXYGEN 99 L/100L E 20171231 65689-001_98568ef1-68db-4e4d-8e10-600457717942 65689-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990101 NDA NDA205889 Oxygen One, Inc. OXYGEN 992 mL/L N 20181231 65692-0201_b0907da1-8d35-48cd-adc9-f81b00e2a10c 65692-0201 HUMAN OTC DRUG Vanilla Mint Lip SPF 30 Balm AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20161219 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .12; .32; .21; .1; .25 g/4.25g; g/4.25g; g/4.25g; g/4.25g; g/4.25g N 20181231 65692-0301_615914d2-bd21-4048-e053-2991aa0a41d8 65692-0301 HUMAN OTC DRUG Spearmint SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g N 20181231 65692-0302_615914d2-bd21-4048-e053-2991aa0a41d8 65692-0302 HUMAN OTC DRUG Beeswax SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g N 20181231 65692-0303_615914d2-bd21-4048-e053-2991aa0a41d8 65692-0303 HUMAN OTC DRUG Pomegranate SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g N 20181231 65692-0304_615914d2-bd21-4048-e053-2991aa0a41d8 65692-0304 HUMAN OTC DRUG Tropical SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g N 20181231 65692-0305_615914d2-bd21-4048-e053-2991aa0a41d8 65692-0305 HUMAN OTC DRUG Vanilla SPF 15 Lip AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE STICK TOPICAL 20121201 OTC MONOGRAPH FINAL part352 Raining Rose, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .09; .28; .21; .06 g/4.25g; g/4.25g; g/4.25g; g/4.25g N 20181231 65692-0412_f3b829d1-68b3-4e0c-a77a-130310138a14 65692-0412 HUMAN OTC DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20150801 OTC MONOGRAPH NOT FINAL part343 Raining Rose Inc. IBUPROFEN 200 mg/1 N 20181231 65692-0502_46c58823-0453-00b7-e054-00144ff88e88 65692-0502 HUMAN OTC DRUG Iced Pear SPF 15 Broad Spectrum Lip Balm Iced Pear SPF 15 Broad Spectrum Lip Balm STICK TOPICAL 20160216 OTC MONOGRAPH FINAL part352 Raining Rose, Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE; OCTINOXATE .09; .21; .06; .28 g/4.25g; g/4.25g; g/4.25g; g/4.25g N 20181231 65692-0588_f234a643-d321-42ce-9e8c-54e13870d2b2 65692-0588 HUMAN OTC DRUG PowerPatch Dark Spot Protector AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXBENZONE GEL TOPICAL 20160901 OTC MONOGRAPH FINAL part352 Raining Rose AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .6; 1.6; 1; .56; .6 g/20mL; g/20mL; g/20mL; g/20mL; g/20mL N 20181231 65692-1001_045aa4c0-de11-49ac-ade1-c590ed992d38 65692-1001 HUMAN OTC DRUG Raining Rose Antiseptic Hand Sanitizer ETHYL ALCOHOL SPRAY TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333E Raining Rose, Inc. ALCOHOL 62 mL/100mL N 20181231 65692-1002_416267f2-85c6-6633-e054-00144ff8d46c 65692-1002 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20161116 OTC MONOGRAPH NOT FINAL part333E Raining Rose, Inc. ALCOHOL 65 mL/100mL N 20181231 65692-1003_43aaebc2-c295-4689-e054-00144ff88e88 65692-1003 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20161215 OTC MONOGRAPH NOT FINAL part333E Raining Rose, Inc. ALCOHOL 62 mL/100mL N 20181231 65692-2970_ff32e5f5-f94d-4a7a-a79e-0b94831606bd 65692-2970 HUMAN OTC DRUG After-BUG OATMEAL STICK TOPICAL 20160331 OTC MONOGRAPH FINAL part347 Raining Rose OATMEAL 1.7 g/17g N 20181231 65692-4720_4ccf10b7-f548-4542-b671-a5fba926a642 65692-4720 HUMAN OTC DRUG ALL SEASON FACE ZINC OXIDE STICK TOPICAL 20160331 OTC MONOGRAPH FINAL part352 Raining Rose Inc. ZINC OXIDE 4.14 g/18.4g N 20181231 65700-1649_9c256247-c1cf-4051-88f6-1f638607a868 65700-1649 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20000101 NDA NDA205849 Major Medical Supply LLC OXYGEN 99 L/100L N 20181231 65703-5044_610d08c6-b585-46cf-8aaf-49c97256cbc7 65703-5044 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000524 UNAPPROVED MEDICAL GAS Complete Care Medical Inc. OXYGEN 99 L/100L E 20171231 65722-0123_908a0fae-3e15-4ed6-8a43-b479111741ec 65722-0123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20080801 UNAPPROVED MEDICAL GAS Aretsia Medical Supply OXYGEN 99 L/100L E 20171231 65727-065_3ff17740-c7a8-095b-f5fc-78e73ab285f6 65727-065 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20151217 ANDA ANDA078034 Biocon Limited SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 65727-066_3ff17740-c7a8-095b-f5fc-78e73ab285f6 65727-066 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20151217 ANDA ANDA078034 Biocon Limited SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 65727-067_3ff17740-c7a8-095b-f5fc-78e73ab285f6 65727-067 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20151217 ANDA ANDA078034 Biocon Limited SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 65727-068_3ff17740-c7a8-095b-f5fc-78e73ab285f6 65727-068 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20151217 ANDA ANDA078034 Biocon Limited SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 65727-069_3ff17740-c7a8-095b-f5fc-78e73ab285f6 65727-069 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20151217 ANDA ANDA078034 Biocon Limited SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 65734-000_fff42904-fe50-4b45-ab9b-87ba73b35328 65734-000 HUMAN OTC DRUG 3-Step First Aid Kit Povidone-Iodine, Lidocaine Hydrochloride, Benzalkonium Chloride KIT TOPICAL 20030301 OTC MONOGRAPH FINAL part333C Swabplus Inc. N 20181231 65734-001_84b830cf-b025-4864-aef5-6db67b88bb15 65734-001 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Swabplus Inc. ISOPROPYL ALCOHOL .105 mL/.15mL N 20181231 65734-101_0d8ca63a-b191-44fb-acf4-d24aed0a79cf 65734-101 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Swabplus Inc. ISOPROPYL ALCOHOL .105 mL/.15mL N 20181231 65734-270_12c48fc2-d20c-40b5-ba67-0087127c27d8 65734-270 HUMAN OTC DRUG Antiseptic Formula Filled Swab Lidocaine Hydrochloride, Benzalkonium Chloride LIQUID TOPICAL 20030301 OTC MONOGRAPH NOT FINAL part348 Swabplus Inc. LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE 100; 11 mg/10mL; mg/10mL N 20181231 65734-300_9fd0892f-7e64-41a4-9ec0-dbc3262cb1db 65734-300 HUMAN OTC DRUG Insect Bite Relief Benzocaine SOLUTION TOPICAL 20030301 OTC MONOGRAPH FINAL part346 Swabplus Inc. BENZOCAINE 150 mg/mL N 20181231 65734-317_c48c86d9-739b-4456-b434-3bd18cab0d9b 65734-317 HUMAN OTC DRUG Iodine Povidone-Iodine SOLUTION TOPICAL 20030301 OTC MONOGRAPH FINAL part333C Swabplus Inc. POVIDONE-IODINE 10 mg/mL N 20181231 65734-348_5bc934c7-f185-4f4f-b866-26591873fbe9 65734-348 HUMAN OTC DRUG Fungus Relief Tolnaftate SOLUTION TOPICAL 20030301 OTC MONOGRAPH FINAL part333C Swabplus Inc. TOLNAFTATE 10 mg/mL N 20181231 65734-511_4edad3eb-85be-41d6-8965-1859bddc3576 65734-511 HUMAN OTC DRUG Isodine Copitos Povidone-Iodine SOLUTION TOPICAL 20080601 OTC MONOGRAPH FINAL part333C Swabplus Inc. POVIDONE-IODINE 10 mg/mL N 20181231 65734-740_6f8925f9-5bce-4dba-aeca-1887b252b614 65734-740 HUMAN OTC DRUG Advance Acne Care Salicylic Acid, Silver KIT TOPICAL 20080807 OTC MONOGRAPH FINAL part333D Swabplus Inc. N 20181231 65734-867_76bd4316-2ca7-4e6d-a63c-d8a51b2ae6e0 65734-867 HUMAN OTC DRUG Mouth Sore Relief Applicator Benzocaine LIQUID ORAL 20050601 OTC MONOGRAPH FINAL part333B Swabplus Inc. BENZOCAINE 200 mg/mL N 20181231 65753-100_5ef74e6a-52ae-46e9-e053-2991aa0a53e4 65753-100 HUMAN OTC DRUG CoreTex Sun X SPF 30 Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130125 OTC MONOGRAPH NOT FINAL part352 CoreTex Products AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 1; 5; 7.5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 65753-102_5ef777a8-67c4-71b9-e053-2991aa0a1cb0 65753-102 HUMAN OTC DRUG Sun X Multi-Pack SPF 30 Thick Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone KIT TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 CoreTex Products Inc N 20181231 65753-105_5f0b530a-d4a8-cd6f-e053-2991aa0a1d03 65753-105 HUMAN OTC DRUG Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LIPSTICK TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 CoreTex Products, INC OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE; HOMOSALATE 5; 2.5; 6; 3; 7.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 65757-300_9e524c53-e3fe-4b53-9efc-d2a4142d2343 65757-300 HUMAN PRESCRIPTION DRUG VIVITROL naltrexone KIT 20060613 NDA NDA021897 Alkermes, Inc. N 20181231 65757-401_6346fbb7-8257-4b61-9301-3eb408a17646 65757-401 HUMAN PRESCRIPTION DRUG ARISTADA aripiprazole lauroxil INJECTION, SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 20151005 NDA NDA207533 Alkermes, Inc. ARIPIPRAZOLE LAUROXIL 441 mg/1.6mL N 20181231 65757-402_6346fbb7-8257-4b61-9301-3eb408a17646 65757-402 HUMAN PRESCRIPTION DRUG ARISTADA aripiprazole lauroxil INJECTION, SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 20151005 NDA NDA207533 Alkermes, Inc. ARIPIPRAZOLE LAUROXIL 662 mg/2.4mL N 20181231 65757-403_6346fbb7-8257-4b61-9301-3eb408a17646 65757-403 HUMAN PRESCRIPTION DRUG ARISTADA aripiprazole lauroxil INJECTION, SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 20151005 NDA NDA207533 Alkermes, Inc. ARIPIPRAZOLE LAUROXIL 882 mg/3.2mL N 20181231 65757-404_6346fbb7-8257-4b61-9301-3eb408a17646 65757-404 HUMAN PRESCRIPTION DRUG ARISTADA aripiprazole lauroxil INJECTION, SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 20170605 NDA NDA207533 Alkermes, Inc. ARIPIPRAZOLE LAUROXIL 1064 mg/3.9mL N 20181231 65785-034_2593e97a-c175-418a-9234-2b020af7c32b 65785-034 HUMAN OTC DRUG Eyewash Station Additive Concentrate Chlorhexidine gluconate and Propylene Glycol LIQUID OPHTHALMIC 20111115 OTC MONOGRAPH NOT FINAL part349 Niagara Pharmaceuticals Inc. CHLORHEXIDINE GLUCONATE; PROPYLENE GLYCOL 145.6; 280 kg/2800L; kg/2800L N 20181231 65785-160_c88015eb-5a95-4fe0-ab6e-d958abc7e03a 65785-160 HUMAN OTC DRUG PUR-WASH Water SOLUTION OPHTHALMIC 20110912 NDA NDA022305 Niagara Pharmaceuticals Inc. WATER 929 g/946mL N 20181231 65785-162_c88015eb-5a95-4fe0-ab6e-d958abc7e03a 65785-162 HUMAN OTC DRUG PUR-WASH Water SOLUTION OPHTHALMIC 20110912 NDA NDA022305 Niagara Pharmaceuticals Inc. WATER 929 g/946mL N 20181231 65785-164_aeb7ee26-02c6-4e62-a27e-89e2acc2b343 65785-164 HUMAN OTC DRUG PUR-WASH Water SOLUTION OPHTHALMIC 20110912 NDA NDA022305 Niagara Pharmaceuticals Inc. WATER 929 g/946mL N 20181231 65785-166_edbfeaa1-7a5e-4683-b97d-f302bec9343f 65785-166 HUMAN OTC DRUG PUR-WASH Water SOLUTION OPHTHALMIC 20130524 NDA NDA022305 Niagara Pharmaceuticals Inc. WATER 929 g/946mL N 20181231 65785-168_5c8ccac3-7def-0c09-e053-2991aa0aeac9 65785-168 HUMAN OTC DRUG Pur-Wash Eyewash SOLUTION OPHTHALMIC 20150130 NDA NDA022305 Niagara Pharmaceuticals, Inc. WATER 473 mL/473mL N 20181231 65786-1717_d1491d8b-2bb2-43a5-ab17-a9548a9f5b6e 65786-1717 HUMAN OTC DRUG KleerSight Chlorhexidine Gluconate CONCENTRATE IRRIGATION 20100311 UNAPPROVED DRUG OTHER Bradley Fixtures Corporation CHLORHEXIDINE GLUCONATE 2.36 mL/236mL E 20171231 65802-001_34be7da2-4ef0-4c3e-9b81-fbbe2f9bbbf6 65802-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Aspirus Keweenaw Home Medical Equipment OXYGEN 99 L/100L E 20171231 65808-024_9dfef338-d06f-40b6-853f-7c3f1e6a45f1 65808-024 HUMAN OTC DRUG Cold and Flu Relief Aconitum napellus, Allium cepa, Gelsemium supervirens, Justica adhatoda, Kali Bichromicum, Pulsatill nigricans, Sanguinaria canadensis, Sticta pulmonaria, Camphora Offcianarum TABLET ORAL 20091021 UNAPPROVED HOMEOPATHIC GMP Laboratories of America, Inc ACONITUM NAPELLUS; ONION; GELSEMIUM SEMPERVIRENS ROOT; JUSTICIA ADHATODA LEAF; POTASSIUM CHROMATE; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; LOBARIA PULMONARIA; CAMPHOR (NATURAL) 4; 4; 4; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 65811-0001_1aa70ce0-bb47-4e50-a5b3-ac8de65a471f 65811-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000720 UNAPPROVED MEDICAL GAS Randle Respiratory Care, Inc. OXYGEN 99 L/100L E 20171231 65840-100_98963a9d-ade4-4254-ab78-64830dd0d15b 65840-100 HUMAN OTC DRUG Super Bump Relief benzoyl peroxide and salicylic acid CREAM TOPICAL 20110608 OTC MONOGRAPH NOT FINAL part333D Elements Personal Care, Inc. BENZOYL PEROXIDE; SALICYLIC ACID 4; 3 g/100g; g/100g E 20171231 65841-022_89889b5d-f7cf-4d7d-96ad-1d9f20437f45 65841-022 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Cadila Healthcare Limited ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65841-023_89889b5d-f7cf-4d7d-96ad-1d9f20437f45 65841-023 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Cadila Healthcare Limited ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65841-024_89889b5d-f7cf-4d7d-96ad-1d9f20437f45 65841-024 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Cadila Healthcare Limited ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65841-027_c70a767e-8127-462a-8c7c-d116fa92d0ea 65841-027 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20050928 ANDA ANDA077060 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-028_b5782eec-4370-4fe8-89a1-a86d90c7ac39 65841-028 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100320 ANDA ANDA077064 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-028_c70a767e-8127-462a-8c7c-d116fa92d0ea 65841-028 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-029_b5782eec-4370-4fe8-89a1-a86d90c7ac39 65841-029 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100320 ANDA ANDA077064 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-029_c70a767e-8127-462a-8c7c-d116fa92d0ea 65841-029 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-030_b5782eec-4370-4fe8-89a1-a86d90c7ac39 65841-030 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100320 ANDA ANDA077064 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-030_c70a767e-8127-462a-8c7c-d116fa92d0ea 65841-030 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-039_c70a767e-8127-462a-8c7c-d116fa92d0ea 65841-039 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20050928 ANDA ANDA077078 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-040_cc75866d-3e28-4e21-a37a-ce1e03c0c65a 65841-040 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Cadila Healthcare Limited PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 65841-041_cc75866d-3e28-4e21-a37a-ce1e03c0c65a 65841-041 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Cadila Healthcare Limited PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 65841-042_cc75866d-3e28-4e21-a37a-ce1e03c0c65a 65841-042 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Cadila Healthcare Limited PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 65841-043_7ec1c7a8-545d-460f-9d1f-acbd2322b3f0 65841-043 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20171202 ANDA ANDA077106 Cadila Healthcare Limited SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65841-044_7ec1c7a8-545d-460f-9d1f-acbd2322b3f0 65841-044 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20171202 ANDA ANDA077106 Cadila Healthcare Limited SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65841-045_7ec1c7a8-545d-460f-9d1f-acbd2322b3f0 65841-045 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20171202 ANDA ANDA077106 Cadila Healthcare Limited SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65841-046_bcdebc23-2824-45d3-8539-23088ccc5394 65841-046 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Cadila Healthcare Limited RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20191231 65841-050_cd58f847-6b8b-4326-a527-9f29458ca2f2 65841-050 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 Cadila Healthcare Limited MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 65841-051_cd58f847-6b8b-4326-a527-9f29458ca2f2 65841-051 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 Cadila Healthcare Limited MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 65841-052_a387212c-a524-492a-8186-8de1a02f69b9 65841-052 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65841-053_a387212c-a524-492a-8186-8de1a02f69b9 65841-053 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65841-054_a387212c-a524-492a-8186-8de1a02f69b9 65841-054 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65841-055_a387212c-a524-492a-8186-8de1a02f69b9 65841-055 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65841-056_a387212c-a524-492a-8186-8de1a02f69b9 65841-056 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65841-057_a387212c-a524-492a-8186-8de1a02f69b9 65841-057 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65841-058_a387212c-a524-492a-8186-8de1a02f69b9 65841-058 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65841-059_a387212c-a524-492a-8186-8de1a02f69b9 65841-059 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65841-064_a387212c-a524-492a-8186-8de1a02f69b9 65841-064 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Cadila Healthcare Limited WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 65841-065_ecd9fcdd-6e67-4ee1-98d6-4232672312d5 65841-065 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Cadila Healthcare Limited SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65841-066_ecd9fcdd-6e67-4ee1-98d6-4232672312d5 65841-066 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Cadila Healthcare Limited SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65841-067_ecd9fcdd-6e67-4ee1-98d6-4232672312d5 65841-067 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Cadila Healthcare Limited SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65841-068_ecd9fcdd-6e67-4ee1-98d6-4232672312d5 65841-068 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Cadila Healthcare Limited SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65841-069_ecd9fcdd-6e67-4ee1-98d6-4232672312d5 65841-069 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Cadila Healthcare Limited SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65841-097_af56bbad-9fe9-4a38-ad55-4f374cd3d617 65841-097 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Cadila Healthcare Limited PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65841-098_af56bbad-9fe9-4a38-ad55-4f374cd3d617 65841-098 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Cadila Healthcare Limited PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65841-099_af56bbad-9fe9-4a38-ad55-4f374cd3d617 65841-099 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Cadila Healthcare Limited PAROXETINE HYDROCHLORIDE ANHYDROUS 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65841-129_bcdebc23-2824-45d3-8539-23088ccc5394 65841-129 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Cadila Healthcare Limited RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20191231 65841-260_f64de397-76c5-4974-998c-57464f40fe21 65841-260 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20060125 ANDA ANDA077224 Cadila Healthcare Limited RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 65841-536_b02d704e-e241-4acf-97ca-1db0cff62ad0 65841-536 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20140812 ANDA ANDA203546 Cadila Healthcare Limited POTASSIUM CITRATE 5 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 65841-537_b02d704e-e241-4acf-97ca-1db0cff62ad0 65841-537 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20140812 ANDA ANDA203546 Cadila Healthcare Limited POTASSIUM CITRATE 10 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 65841-538_b02d704e-e241-4acf-97ca-1db0cff62ad0 65841-538 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20140812 ANDA ANDA203546 Cadila Healthcare Limited POTASSIUM CITRATE 15 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 65841-601_af56bbad-9fe9-4a38-ad55-4f374cd3d617 65841-601 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Cadila Healthcare Limited PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65841-602_8e92b44e-846e-4f38-8187-97062a91930d 65841-602 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20070711 ANDA ANDA077621 Cadila Healthcare Limited AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] E 20171231 65841-603_bcdebc23-2824-45d3-8539-23088ccc5394 65841-603 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Cadila Healthcare Limited RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20191231 65841-606_9bdd03c8-f71f-4751-a6a0-8ab1bc05f1bd 65841-606 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20171206 ANDA ANDA079017 Cadila Healthcare Limited ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65841-607_9bdd03c8-f71f-4751-a6a0-8ab1bc05f1bd 65841-607 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20171206 ANDA ANDA079017 Cadila Healthcare Limited ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65841-608_9bdd03c8-f71f-4751-a6a0-8ab1bc05f1bd 65841-608 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20171206 ANDA ANDA079017 Cadila Healthcare Limited ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65841-609_9bdd03c8-f71f-4751-a6a0-8ab1bc05f1bd 65841-609 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20171206 ANDA ANDA079017 Cadila Healthcare Limited ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65841-610_9bdd03c8-f71f-4751-a6a0-8ab1bc05f1bd 65841-610 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20171206 ANDA ANDA079017 Cadila Healthcare Limited ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65841-611_9bdd03c8-f71f-4751-a6a0-8ab1bc05f1bd 65841-611 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20171206 ANDA ANDA079017 Cadila Healthcare Limited ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65841-613_bbed96d4-fcfd-4471-872b-2a0fafb48a4f 65841-613 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20090706 ANDA ANDA079089 Cadila Healthcare Limited BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 65841-614_71b9e146-b4f6-46d8-9534-e513f8e33247 65841-614 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070904 ANDA ANDA040597 Cadila Healthcare Limited BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 65841-615_71b9e146-b4f6-46d8-9534-e513f8e33247 65841-615 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070904 ANDA ANDA040597 Cadila Healthcare Limited BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 65841-616_832c9475-8aa6-41e7-8a66-136eac0d22d6 65841-616 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Cadila Healthcare Limited CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 65841-617_832c9475-8aa6-41e7-8a66-136eac0d22d6 65841-617 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Cadila Healthcare Limited CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 65841-618_832c9475-8aa6-41e7-8a66-136eac0d22d6 65841-618 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Cadila Healthcare Limited CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 65841-619_832c9475-8aa6-41e7-8a66-136eac0d22d6 65841-619 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Cadila Healthcare Limited CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 65841-620_4f393918-efe0-4b23-9c8b-e6a95af4eaeb 65841-620 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Cadila Healthcare Limited AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65841-621_4f393918-efe0-4b23-9c8b-e6a95af4eaeb 65841-621 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Cadila Healthcare Limited AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65841-622_4f393918-efe0-4b23-9c8b-e6a95af4eaeb 65841-622 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Cadila Healthcare Limited AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65841-626_f8c8df2c-7e9d-4757-9ce8-3450d3569591 65841-626 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 Cadila Healthcare Limited HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 65841-627_f8c8df2c-7e9d-4757-9ce8-3450d3569591 65841-627 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 Cadila Healthcare Limited HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] N 20181231 65841-628_f8c8df2c-7e9d-4757-9ce8-3450d3569591 65841-628 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 Cadila Healthcare Limited HALOPERIDOL 20 mg/1 Typical Antipsychotic [EPC] N 20181231 65841-631_2658d6d1-cf5c-48ff-b9ab-d3183307f16f 65841-631 HUMAN PRESCRIPTION DRUG Amiodarone hydrochloride Amiodarone hydrochloride TABLET ORAL 20090810 ANDA ANDA079029 Cadila Healthcare Limited AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 65841-632_bcdebc23-2824-45d3-8539-23088ccc5394 65841-632 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Cadila Healthcare Limited RIBAVIRIN 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20191231 65841-633_14f8d2c0-0451-4f46-9a54-429194c243a6 65841-633 HUMAN PRESCRIPTION DRUG Hydroxychloroquine sulfate Hydroxychloroquine sulfate TABLET, FILM COATED ORAL 20080103 ANDA ANDA040657 Cadila Healthcare Limited HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 65841-634_a3d327e9-18f1-4302-8728-55ea3911cc01 65841-634 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 Cadila Healthcare Limited DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-635_a3d327e9-18f1-4302-8728-55ea3911cc01 65841-635 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 Cadila Healthcare Limited DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-636_a3d327e9-18f1-4302-8728-55ea3911cc01 65841-636 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 Cadila Healthcare Limited DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-637_8c74864b-d2dd-4e4c-91ab-f045e426b1a5 65841-637 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130107 ANDA ANDA078239 Cadila Healthcare Limited DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-638_8c74864b-d2dd-4e4c-91ab-f045e426b1a5 65841-638 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130107 ANDA ANDA078239 Cadila Healthcare Limited DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-639_28a446d6-6b78-4ad1-a519-dd581a017130 65841-639 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium CAPSULE, COATED PELLETS ORAL 20090127 ANDA ANDA078919 Cadila Healthcare Limited DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-640_69b58c61-5ad0-4c44-bf68-0811a09a0f90 65841-640 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100629 ANDA ANDA078516 Cadila Healthcare Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 65841-641_69b58c61-5ad0-4c44-bf68-0811a09a0f90 65841-641 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100629 ANDA ANDA078516 Cadila Healthcare Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 65841-642_69b58c61-5ad0-4c44-bf68-0811a09a0f90 65841-642 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100629 ANDA ANDA078516 Cadila Healthcare Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 65841-647_9f0a22e6-ba95-4a27-a0a6-492a5a244dea 65841-647 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Cadila Healthcare Limited TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65841-648_9f0a22e6-ba95-4a27-a0a6-492a5a244dea 65841-648 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Cadila Healthcare Limited TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65841-649_9f0a22e6-ba95-4a27-a0a6-492a5a244dea 65841-649 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Cadila Healthcare Limited TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65841-650_9f0a22e6-ba95-4a27-a0a6-492a5a244dea 65841-650 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Cadila Healthcare Limited TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65841-651_08159a1c-c08c-4d4e-acf6-20f52836a47d 65841-651 HUMAN PRESCRIPTION DRUG topiramate topiramate CAPSULE, COATED PELLETS ORAL 20091014 ANDA ANDA078877 Cadila Healthcare Limited TOPIRAMATE 15 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65841-652_08159a1c-c08c-4d4e-acf6-20f52836a47d 65841-652 HUMAN PRESCRIPTION DRUG topiramate topiramate CAPSULE, COATED PELLETS ORAL 20091014 ANDA ANDA078877 Cadila Healthcare Limited TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65841-654_ff27594e-f32d-4bf3-8bfe-c09e45faa588 65841-654 HUMAN PRESCRIPTION DRUG Bromocriptine mesylate Bromocriptine mesylate CAPSULE ORAL 20090123 ANDA ANDA078899 Cadila Healthcare Limited BROMOCRIPTINE MESYLATE 5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 65841-655_2d675dff-582d-4181-96d1-6bffbb00b982 65841-655 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Cadila Healthcare Limited RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65841-656_2d675dff-582d-4181-96d1-6bffbb00b982 65841-656 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Cadila Healthcare Limited RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65841-657_2d675dff-582d-4181-96d1-6bffbb00b982 65841-657 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Cadila Healthcare Limited RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65841-658_2d675dff-582d-4181-96d1-6bffbb00b982 65841-658 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Cadila Healthcare Limited RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65841-659_9b18bd2a-2165-4d7b-abcd-b1de67431715 65841-659 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20160505 ANDA ANDA078905 Cadila Healthcare Limited GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65841-660_9b18bd2a-2165-4d7b-abcd-b1de67431715 65841-660 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20160505 ANDA ANDA078905 Cadila Healthcare Limited GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-661_9b18bd2a-2165-4d7b-abcd-b1de67431715 65841-661 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20160505 ANDA ANDA078905 Cadila Healthcare Limited GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-662_fcf151dd-e0b3-4a0c-b148-8e5be1342f2d 65841-662 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080522 ANDA ANDA040874 Cadila Healthcare Limited DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 65841-663_fcf151dd-e0b3-4a0c-b148-8e5be1342f2d 65841-663 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080522 ANDA ANDA040874 Cadila Healthcare Limited DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 65841-664_fcf151dd-e0b3-4a0c-b148-8e5be1342f2d 65841-664 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080522 ANDA ANDA040874 Cadila Healthcare Limited DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 65841-665_2513d76e-a1f3-43be-a2c9-62b3f2ec1a30 65841-665 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cadila Healthcare Limited RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 65841-666_2513d76e-a1f3-43be-a2c9-62b3f2ec1a30 65841-666 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cadila Healthcare Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 65841-667_2513d76e-a1f3-43be-a2c9-62b3f2ec1a30 65841-667 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cadila Healthcare Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 65841-668_2513d76e-a1f3-43be-a2c9-62b3f2ec1a30 65841-668 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cadila Healthcare Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 65841-669_2513d76e-a1f3-43be-a2c9-62b3f2ec1a30 65841-669 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081112 ANDA ANDA078040 Cadila Healthcare Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 65841-670_2513d76e-a1f3-43be-a2c9-62b3f2ec1a30 65841-670 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Cadila Healthcare Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 65841-671_bc985772-e546-450c-b47f-20dce221c69d 65841-671 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65841-672_bc985772-e546-450c-b47f-20dce221c69d 65841-672 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65841-673_bc985772-e546-450c-b47f-20dce221c69d 65841-673 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65841-674_bc985772-e546-450c-b47f-20dce221c69d 65841-674 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65841-675_bc985772-e546-450c-b47f-20dce221c69d 65841-675 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20080613 ANDA ANDA077653 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65841-676_68d38539-76a5-48a1-be0a-e081eaced25e 65841-676 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20171109 ANDA ANDA078620 Cadila Healthcare Limited NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65841-677_68d38539-76a5-48a1-be0a-e081eaced25e 65841-677 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20171109 ANDA ANDA078620 Cadila Healthcare Limited NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65841-678_68d38539-76a5-48a1-be0a-e081eaced25e 65841-678 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20171109 ANDA ANDA078620 Cadila Healthcare Limited NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65841-680_45b6508d-c6c1-425f-aa62-97c15ed25a31 65841-680 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20090504 ANDA ANDA065433 Cadila Healthcare Limited MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] E 20171231 65841-681_45b6508d-c6c1-425f-aa62-97c15ed25a31 65841-681 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET, FILM COATED ORAL 20090504 ANDA ANDA065477 Cadila Healthcare Limited MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] E 20171231 65841-682_4538b6c5-79c4-4a61-9327-2ca81438ce0a 65841-682 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Cadila Healthcare Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-683_4538b6c5-79c4-4a61-9327-2ca81438ce0a 65841-683 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Cadila Healthcare Limited LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-684_4538b6c5-79c4-4a61-9327-2ca81438ce0a 65841-684 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Cadila Healthcare Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-685_4538b6c5-79c4-4a61-9327-2ca81438ce0a 65841-685 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Cadila Healthcare Limited LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-686_4538b6c5-79c4-4a61-9327-2ca81438ce0a 65841-686 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Cadila Healthcare Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-687_4538b6c5-79c4-4a61-9327-2ca81438ce0a 65841-687 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Cadila Healthcare Limited LAMOTRIGINE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-689_4538b6c5-79c4-4a61-9327-2ca81438ce0a 65841-689 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090123 ANDA ANDA078009 Cadila Healthcare Limited LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-690_4538b6c5-79c4-4a61-9327-2ca81438ce0a 65841-690 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090123 ANDA ANDA078009 Cadila Healthcare Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65841-691_66e7ea06-510d-49e2-91b7-038e4375e6cf 65841-691 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Cadila Healthcare Limited LEVOFLOXACIN 250 mg/1 N 20181231 65841-692_66e7ea06-510d-49e2-91b7-038e4375e6cf 65841-692 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20101110 ANDA ANDA077652 Cadila Healthcare Limited LEVOFLOXACIN 500 mg/1 N 20181231 65841-693_66e7ea06-510d-49e2-91b7-038e4375e6cf 65841-693 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Cadila Healthcare Limited LEVOFLOXACIN 750 mg/1 N 20181231 65841-695_cbfa3f00-aad4-410a-ab10-62c436d0022e 65841-695 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078225 Cadila Healthcare Limited TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 65841-699_e0a609b8-34bc-4105-ae42-a1880a796bbc 65841-699 HUMAN PRESCRIPTION DRUG Ramipril Ramipril TABLET ORAL 20171205 ANDA ANDA090697 Cadila Healthcare Limited RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65841-700_e0a609b8-34bc-4105-ae42-a1880a796bbc 65841-700 HUMAN PRESCRIPTION DRUG Ramipril Ramipril TABLET ORAL 20171205 ANDA ANDA090697 Cadila Healthcare Limited RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65841-701_e0a609b8-34bc-4105-ae42-a1880a796bbc 65841-701 HUMAN PRESCRIPTION DRUG Ramipril Ramipril TABLET ORAL 20171205 ANDA ANDA090697 Cadila Healthcare Limited RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65841-702_e0a609b8-34bc-4105-ae42-a1880a796bbc 65841-702 HUMAN PRESCRIPTION DRUG Ramipril Ramipril TABLET ORAL 20171205 ANDA ANDA090697 Cadila Healthcare Limited RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65841-703_94a345d3-d95b-421b-ac2e-e3c36740ffb2 65841-703 HUMAN PRESCRIPTION DRUG levetiracetam levetiracetam TABLET, FILM COATED ORAL 20171205 ANDA ANDA078918 Cadila Healthcare Limited LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65841-704_94a345d3-d95b-421b-ac2e-e3c36740ffb2 65841-704 HUMAN PRESCRIPTION DRUG levetiracetam levetiracetam TABLET, FILM COATED ORAL 20171205 ANDA ANDA078918 Cadila Healthcare Limited LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65841-705_081900e2-9387-4afe-b26f-ab1ee380d41c 65841-705 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20121016 ANDA ANDA078926 Cadila Healthcare Limited GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65841-706_081900e2-9387-4afe-b26f-ab1ee380d41c 65841-706 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20121016 ANDA ANDA078926 Cadila Healthcare Limited GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65841-711_36f5edc8-063f-4506-b856-0c41dd2f7913 65841-711 HUMAN OTC DRUG OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED NASAL 20090924 OTC MONOGRAPH NOT FINAL part341 Cadila Healthcare Limited OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 65841-712_e3905862-b076-4eef-a39d-9ac920365376 65841-712 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65841-713_e3905862-b076-4eef-a39d-9ac920365376 65841-713 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65841-714_e3905862-b076-4eef-a39d-9ac920365376 65841-714 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65841-715_e3905862-b076-4eef-a39d-9ac920365376 65841-715 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65841-716_e3905862-b076-4eef-a39d-9ac920365376 65841-716 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65841-717_e3905862-b076-4eef-a39d-9ac920365376 65841-717 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65841-718_e3905862-b076-4eef-a39d-9ac920365376 65841-718 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Cadila Healthcare Limited ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65841-721_d39bd3ea-8e10-48fb-8251-627708f694c9 65841-721 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA090175 Cadila Healthcare Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65841-722_d39bd3ea-8e10-48fb-8251-627708f694c9 65841-722 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA090175 Cadila Healthcare Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65841-729_75ad07d6-ecd6-4743-a1f2-fb38515c5c01 65841-729 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Cadila Healthcare Limited LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65841-730_75ad07d6-ecd6-4743-a1f2-fb38515c5c01 65841-730 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Cadila Healthcare Limited LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65841-731_75ad07d6-ecd6-4743-a1f2-fb38515c5c01 65841-731 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Cadila Healthcare Limited LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65841-732_a11713c2-a904-4c90-815e-14d2c1f475db 65841-732 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20100410 ANDA ANDA078385 Cadila Healthcare Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65841-733_a11713c2-a904-4c90-815e-14d2c1f475db 65841-733 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20100410 ANDA ANDA078385 Cadila Healthcare Limited HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65841-734_ec54878e-f258-4b45-bd0b-171384d3f61a 65841-734 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100710 ANDA ANDA078920 Cadila Healthcare Limited PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 65841-735_ec54878e-f258-4b45-bd0b-171384d3f61a 65841-735 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100710 ANDA ANDA078920 Cadila Healthcare Limited PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 65841-736_ec54878e-f258-4b45-bd0b-171384d3f61a 65841-736 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100710 ANDA ANDA078920 Cadila Healthcare Limited PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 65841-737_ec54878e-f258-4b45-bd0b-171384d3f61a 65841-737 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100710 ANDA ANDA078920 Cadila Healthcare Limited PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 65841-738_ec54878e-f258-4b45-bd0b-171384d3f61a 65841-738 HUMAN PRESCRIPTION DRUG PRAMIPEXOLE DIHYDROCHLORIDE PRAMIPEXOLE DIHYDROCHLORIDE TABLET ORAL 20100710 ANDA ANDA078920 Cadila Healthcare Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 65841-739_4f3093f1-925c-4065-91d6-93ee37d21b84 65841-739 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Cadila Healthcare Limited PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65841-740_4f3093f1-925c-4065-91d6-93ee37d21b84 65841-740 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Cadila Healthcare Limited PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65841-741_4f3093f1-925c-4065-91d6-93ee37d21b84 65841-741 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Cadila Healthcare Limited PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65841-742_4f3093f1-925c-4065-91d6-93ee37d21b84 65841-742 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Cadila Healthcare Limited PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65841-743_9bb9b79b-6e9d-4a3f-a3d0-1622a9e5f96d 65841-743 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, COATED ORAL 20100627 ANDA ANDA078921 Cadila Healthcare Limited ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 65841-744_85b17865-72d8-48a2-bb51-6d0906d075da 65841-744 HUMAN PRESCRIPTION DRUG letrozole letrozole TABLET, FILM COATED ORAL 20110603 ANDA ANDA090405 Cadila Healthcare Limited LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 65841-745_e55102eb-608c-481d-af93-1caf96b37013 65841-745 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Cadila Healthcare Limited PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65841-746_e55102eb-608c-481d-af93-1caf96b37013 65841-746 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Cadila Healthcare Limited PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65841-747_e55102eb-608c-481d-af93-1caf96b37013 65841-747 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Cadila Healthcare Limited PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65841-748_e55102eb-608c-481d-af93-1caf96b37013 65841-748 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Cadila Healthcare Limited PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65841-749_d8e282f5-03c4-4185-a354-f848461dcb50 65841-749 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20110525 ANDA ANDA090100 Cadila Healthcare Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65841-750_d8e282f5-03c4-4185-a354-f848461dcb50 65841-750 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20110525 ANDA ANDA090100 Cadila Healthcare Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65841-751_c0355402-c2ff-441e-b95b-802c2983a8d1 65841-751 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65841-752_c0355402-c2ff-441e-b95b-802c2983a8d1 65841-752 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65841-753_c0355402-c2ff-441e-b95b-802c2983a8d1 65841-753 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Cadila Healthcare Limited VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65841-754_5dcef785-2f7e-4311-a52d-af771df167a3 65841-754 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110131 ANDA ANDA090404 Cadila Healthcare Limited TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 65841-755_6159d8b8-3acd-4931-a1f4-8c37f67de922 65841-755 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20111010 ANDA ANDA078898 Cadila Healthcare Limited GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65841-756_6159d8b8-3acd-4931-a1f4-8c37f67de922 65841-756 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20111010 ANDA ANDA078898 Cadila Healthcare Limited GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65841-757_6159d8b8-3acd-4931-a1f4-8c37f67de922 65841-757 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20111010 ANDA ANDA078898 Cadila Healthcare Limited GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65841-758_cbbf77ee-3ff8-46a1-a96f-7ca532bc7f9e 65841-758 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20121015 ANDA ANDA090460 Cadila Healthcare Limited ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 65841-759_ddea93b1-1e8b-49cf-819b-0695af76d5fe 65841-759 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20121123 ANDA ANDA091352 Cadila Healthcare Limited OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 65841-760_ddea93b1-1e8b-49cf-819b-0695af76d5fe 65841-760 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20121123 ANDA ANDA091352 Cadila Healthcare Limited OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 65841-761_ddea93b1-1e8b-49cf-819b-0695af76d5fe 65841-761 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20121123 ANDA ANDA091352 Cadila Healthcare Limited OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 65841-763_a12a5556-3ba3-46c5-921f-5dd66088d86c 65841-763 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20130301 ANDA ANDA091534 Cadila Healthcare Limited RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 65841-764_a12a5556-3ba3-46c5-921f-5dd66088d86c 65841-764 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20130301 ANDA ANDA091534 Cadila Healthcare Limited RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 65841-767_f8164be0-e9dd-4a83-8d66-9a605dc08dc4 65841-767 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130516 ANDA ANDA202890 Cadila Healthcare Limited ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65841-768_f8164be0-e9dd-4a83-8d66-9a605dc08dc4 65841-768 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130516 ANDA ANDA202890 Cadila Healthcare Limited ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65841-769_1d9cc823-807a-4d1e-8cc6-1e1308c44f41 65841-769 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130823 ANDA ANDA202366 Cadila Healthcare Limited LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 65841-770_1d9cc823-807a-4d1e-8cc6-1e1308c44f41 65841-770 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130823 ANDA ANDA202366 Cadila Healthcare Limited LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 65841-771_f3e673a1-33b9-49be-9f4b-6f6e9ed0ce10 65841-771 HUMAN PRESCRIPTION DRUG sirolimus sirolimus TABLET, FILM COATED ORAL 20140115 ANDA ANDA201676 Cadila Healthcare Limited SIROLIMUS .5 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 65841-774_f58fa578-b934-4fe6-8951-6524960aa868 65841-774 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140215 ANDA ANDA090728 Cadila Healthcare Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 65841-775_f58fa578-b934-4fe6-8951-6524960aa868 65841-775 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140215 ANDA ANDA090728 Cadila Healthcare Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 65841-776_f58fa578-b934-4fe6-8951-6524960aa868 65841-776 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140215 ANDA ANDA090728 Cadila Healthcare Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 65841-777_6612f087-c752-4502-baa7-abcfc19ae095 65841-777 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Cadila Healthcare Limited ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65841-778_6612f087-c752-4502-baa7-abcfc19ae095 65841-778 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Cadila Healthcare Limited ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65841-779_6612f087-c752-4502-baa7-abcfc19ae095 65841-779 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Cadila Healthcare Limited ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65841-780_d1abd568-ad41-4323-8ce2-300d62709abc 65841-780 HUMAN PRESCRIPTION DRUG bupropion bupropion TABLET, EXTENDED RELEASE ORAL 20140215 ANDA ANDA201567 Cadila Healthcare Limited BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65841-781_5bdaf414-6977-43ff-9333-a882a67b262c 65841-781 HUMAN PRESCRIPTION DRUG buspirone hydrochloride buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Cadila Healthcare Limited BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 65841-782_5bdaf414-6977-43ff-9333-a882a67b262c 65841-782 HUMAN PRESCRIPTION DRUG buspirone hydrochloride buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Cadila Healthcare Limited BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 65841-783_5bdaf414-6977-43ff-9333-a882a67b262c 65841-783 HUMAN PRESCRIPTION DRUG buspirone hydrochloride buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Cadila Healthcare Limited BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 65841-784_5bdaf414-6977-43ff-9333-a882a67b262c 65841-784 HUMAN PRESCRIPTION DRUG buspirone hydrochloride buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Cadila Healthcare Limited BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 65841-799_f293dfd2-61d6-4be0-8d22-365c7aa792ec 65841-799 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Cadila Healthcare Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65841-800_f293dfd2-61d6-4be0-8d22-365c7aa792ec 65841-800 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Cadila Healthcare Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65841-801_f293dfd2-61d6-4be0-8d22-365c7aa792ec 65841-801 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Cadila Healthcare Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65841-802_7dcf7d4f-c5de-4608-aac4-7c72f54744f9 65841-802 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Cadila Healthcare Limited ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 65841-803_7dcf7d4f-c5de-4608-aac4-7c72f54744f9 65841-803 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Cadila Healthcare Limited ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 65841-804_d1a66435-27b3-4f7b-9b01-a17c8cdc27ee 65841-804 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20140827 ANDA ANDA203325 Cadila Healthcare Limited TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65841-805_d1a66435-27b3-4f7b-9b01-a17c8cdc27ee 65841-805 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20140827 ANDA ANDA203325 Cadila Healthcare Limited TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65841-806_d1a66435-27b3-4f7b-9b01-a17c8cdc27ee 65841-806 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20140827 ANDA ANDA203325 Cadila Healthcare Limited TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65841-809_c70a767e-8127-462a-8c7c-d116fa92d0ea 65841-809 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-810_c70a767e-8127-462a-8c7c-d116fa92d0ea 65841-810 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-811_c70a767e-8127-462a-8c7c-d116fa92d0ea 65841-811 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Cadila Healthcare Limited METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-818_7ebfa53f-feb7-4be8-ab92-fbee9f055895 65841-818 HUMAN PRESCRIPTION DRUG etomidate etomidate INJECTION, SOLUTION INTRAVENOUS 20150403 ANDA ANDA202360 Cadila Healthcare Limited ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 65841-819_ced4beb2-1305-4bf8-a8b6-0bf060b9f22c 65841-819 HUMAN PRESCRIPTION DRUG pyridostigmine bromide pyridostigmine bromide TABLET ORAL 20150807 ANDA ANDA205650 Cadila Healthcare Limited PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65841-821_372fda3a-77cb-465f-9f21-ee85baf3456b 65841-821 HUMAN PRESCRIPTION DRUG doxycycline doxycycline CAPSULE ORAL 20160314 ANDA ANDA205115 Cadila Healthcare Limited DOXYCYCLINE 50 mg/1 N 20181231 65841-822_372fda3a-77cb-465f-9f21-ee85baf3456b 65841-822 HUMAN PRESCRIPTION DRUG doxycycline doxycycline CAPSULE ORAL 20160314 ANDA ANDA205115 Cadila Healthcare Limited DOXYCYCLINE 75 mg/1 N 20181231 65841-823_372fda3a-77cb-465f-9f21-ee85baf3456b 65841-823 HUMAN PRESCRIPTION DRUG doxycycline doxycycline CAPSULE ORAL 20160314 ANDA ANDA205115 Cadila Healthcare Limited DOXYCYCLINE 100 mg/1 N 20181231 65841-824_de7b5693-0366-4754-ad17-5e9d14563fb5 65841-824 HUMAN PRESCRIPTION DRUG glyburide and metformin hydrochloride glyburide and metformin hydrochloride TABLET ORAL 20160407 ANDA ANDA206748 Cadila Healthcare Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-825_de7b5693-0366-4754-ad17-5e9d14563fb5 65841-825 HUMAN PRESCRIPTION DRUG glyburide and metformin hydrochloride glyburide and metformin hydrochloride TABLET ORAL 20160407 ANDA ANDA206748 Cadila Healthcare Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-826_de7b5693-0366-4754-ad17-5e9d14563fb5 65841-826 HUMAN PRESCRIPTION DRUG glyburide and metformin hydrochloride glyburide and metformin hydrochloride TABLET ORAL 20160407 ANDA ANDA206748 Cadila Healthcare Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65841-829_027f8c88-f289-40bd-9822-b886d4d18134 65841-829 HUMAN PRESCRIPTION DRUG acyclovir acyclovir CAPSULE ORAL 20160503 ANDA ANDA204313 Cadila Healthcare Limited ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 65841-830_95b8ee23-bb51-4096-aae9-7ddb261f2896 65841-830 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET ORAL 20160525 ANDA ANDA206747 Cadila Healthcare Limited VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 65841-831_95b8ee23-bb51-4096-aae9-7ddb261f2896 65841-831 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET ORAL 20160525 ANDA ANDA206747 Cadila Healthcare Limited VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 65841-832_b5a1c773-00b7-4673-9cd9-1b52d6528bb8 65841-832 HUMAN PRESCRIPTION DRUG glyburide glyburide TABLET ORAL 20160602 ANDA ANDA206749 Cadila Healthcare Limited GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65841-833_b5a1c773-00b7-4673-9cd9-1b52d6528bb8 65841-833 HUMAN PRESCRIPTION DRUG glyburide glyburide TABLET ORAL 20160602 ANDA ANDA206749 Cadila Healthcare Limited GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65841-834_b5a1c773-00b7-4673-9cd9-1b52d6528bb8 65841-834 HUMAN PRESCRIPTION DRUG glyburide glyburide TABLET ORAL 20160602 ANDA ANDA206749 Cadila Healthcare Limited GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65841-835_47865b1d-7eb6-4959-925f-3dca7d9ead54 65841-835 HUMAN PRESCRIPTION DRUG amantadine hydrochloride amantadine hydrochloride CAPSULE ORAL 20160804 ANDA ANDA208278 Cadila Healthcare Limited AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 65847-205_e6d04dea-cced-479f-bd5f-74f4fd677e00 65847-205 HUMAN PRESCRIPTION DRUG NATRECOR NESIRITIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20010801 NDA NDA020920 Scios LLC NESIRITIDE 1.5 mg/5mL Natriuretic Peptide [EPC],Natriuretic Peptides [Chemical/Ingredient] N 20181231 65856-216_8888bcb8-feca-4045-9a7f-d7d4963699a2 65856-216 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19920101 UNAPPROVED MEDICAL GAS Breathe Easy Therapeutics, Inc OXYGEN 99 L/100L E 20171231 65857-100_cfb9cf65-ee85-472e-9c05-fcd8c975cbe9 65857-100 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F-18 Fludeoxyglucose F-18 INJECTION INTRAVENOUS 20151113 ANDA ANDA203603 Cardinal Health 414, LLC FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 65857-200_72416cda-f6a1-47ef-be8a-207ba7917fef 65857-200 HUMAN PRESCRIPTION DRUG Ammonia N-13 Ammonia N-13 INJECTION INTRAVENOUS 20130225 ANDA ANDA203700 Cardinal Health 414, LLC AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 65857-300_69f71fab-6a8e-4d78-8fd7-5a53dd8a0e07 65857-300 HUMAN PRESCRIPTION DRUG Sodium Fluoride F18 Sodium Fluoride F18 INJECTION INTRAVENOUS 20150730 ANDA ANDA203780 Cardinal Health 414, LLC SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 65857-425_72f31b09-4d7b-475c-b37a-9daf2ad80240 65857-425 HUMAN PRESCRIPTION DRUG Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) tilmanocept KIT 20170920 NDA NDA202207 Cardinal Health 414, LLC N 20181231 65857-450_72f31b09-4d7b-475c-b37a-9daf2ad80240 65857-450 HUMAN PRESCRIPTION DRUG Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) tilmanocept KIT 20170920 NDA NDA202207 Cardinal Health 414, LLC N 20181231 65857-500_4d723a69-72d5-469e-81ce-c67951f3341a 65857-500 HUMAN PRESCRIPTION DRUG Kit for the Preparation of Technetium Tc99m Sestamibi Kit for the Preparation of Technetium Tc99m Sestamibi INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PARENTERAL 20100601 ANDA ANDA078809 Cardinal Health 414, LLC TECHNETIUM TC-99M SESTAMIBI 1 mg/5mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 65862-001_80aed0d4-0fc3-4eb7-8844-dfcab464371f 65862-001 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Aurobindo Pharma Limited MIRTAZAPINE 7.5 mg/1 N 20181231 65862-003_80aed0d4-0fc3-4eb7-8844-dfcab464371f 65862-003 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Aurobindo Pharma Limited MIRTAZAPINE 30 mg/1 N 20181231 65862-005_f705c849-3e52-4029-a7a8-dc128aed80bb 65862-005 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Aurobindo Pharma Limited CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-006_f705c849-3e52-4029-a7a8-dc128aed80bb 65862-006 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Aurobindo Pharma Limited CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-007_f705c849-3e52-4029-a7a8-dc128aed80bb 65862-007 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Aurobindo Pharma Limited CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-008_41c0df32-e25c-487a-abec-1ca2ee73e39b 65862-008 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Aurobindo Pharma Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 65862-009_41c0df32-e25c-487a-abec-1ca2ee73e39b 65862-009 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Aurobindo Pharma Limited METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 65862-010_41c0df32-e25c-487a-abec-1ca2ee73e39b 65862-010 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 Aurobindo Pharma Limited METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 65862-011_0b22a8a1-bfba-4778-a52b-fd3ab2b5b033 65862-011 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 Aurobindo Pharma Limited SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-012_0b22a8a1-bfba-4778-a52b-fd3ab2b5b033 65862-012 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 Aurobindo Pharma Limited SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-013_0b22a8a1-bfba-4778-a52b-fd3ab2b5b033 65862-013 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 Aurobindo Pharma Limited SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-014_4ce64766-6ab6-480a-b776-2568df081503 65862-014 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Aurobindo Pharma Limited AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 65862-015_4ce64766-6ab6-480a-b776-2568df081503 65862-015 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Aurobindo Pharma Limited AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 65862-016_4ce6d1e3-773c-4653-9681-8c0ff01a33d6 65862-016 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Aurobindo Pharma Limited AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 65862-017_4ce6d1e3-773c-4653-9681-8c0ff01a33d6 65862-017 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Aurobindo Pharma Limited AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 65862-018_a8945e2b-d62f-441b-abe9-3beff08b8eea 65862-018 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Aurobindo Pharma Limited CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-019_a8945e2b-d62f-441b-abe9-3beff08b8eea 65862-019 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Aurobindo Pharma Limited CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-021_c2f96689-ac21-467e-b709-b033d0dbb2b6 65862-021 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Aurobindo Pharma Limited MIRTAZAPINE 15 mg/1 N 20181231 65862-022_c2f96689-ac21-467e-b709-b033d0dbb2b6 65862-022 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20051208 ANDA ANDA077376 Aurobindo Pharma Limited MIRTAZAPINE 30 mg/1 N 20181231 65862-023_c2f96689-ac21-467e-b709-b033d0dbb2b6 65862-023 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20060228 ANDA ANDA077376 Aurobindo Pharma Limited MIRTAZAPINE 45 mg/1 N 20181231 65862-024_8339305b-305d-4ea2-b6b2-3479d0f02936 65862-024 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20050919 ANDA ANDA077267 Aurobindo Pharma Limited ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-025_854d18b9-b730-4bc3-bcbe-123aa1ec8422 65862-025 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20161121 ANDA ANDA077464 Aurobindo Pharma Limited LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-026_854d18b9-b730-4bc3-bcbe-123aa1ec8422 65862-026 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20161121 ANDA ANDA077464 Aurobindo Pharma Limited LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-027_0ee9d370-4bd2-433f-bfdb-1598ca6ec692 65862-027 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine TABLET ORAL 20120522 ANDA ANDA077521 Aurobindo Pharma Limited NEVIRAPINE 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 65862-028_fde79250-5dc2-4e80-bbc6-848c938cf6ff 65862-028 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20071018 ANDA ANDA077537 Aurobindo Pharma Limited GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65862-029_fde79250-5dc2-4e80-bbc6-848c938cf6ff 65862-029 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20071018 ANDA ANDA077537 Aurobindo Pharma Limited GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65862-030_fde79250-5dc2-4e80-bbc6-848c938cf6ff 65862-030 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20071018 ANDA ANDA077537 Aurobindo Pharma Limited GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65862-031_80aed0d4-0fc3-4eb7-8844-dfcab464371f 65862-031 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Aurobindo Pharma Limited MIRTAZAPINE 15 mg/1 N 20181231 65862-032_80aed0d4-0fc3-4eb7-8844-dfcab464371f 65862-032 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20041022 ANDA ANDA076921 Aurobindo Pharma Limited MIRTAZAPINE 45 mg/1 N 20181231 65862-036_d40292ff-046c-4a04-b801-10768667951a 65862-036 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20170505 ANDA ANDA077558 Aurobindo Pharma Limited LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-037_176375e4-f8bc-460a-88d3-ffb5eebbb323 65862-037 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-038_176375e4-f8bc-460a-88d3-ffb5eebbb323 65862-038 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-039_176375e4-f8bc-460a-88d3-ffb5eebbb323 65862-039 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-040_176375e4-f8bc-460a-88d3-ffb5eebbb323 65862-040 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-041_176375e4-f8bc-460a-88d3-ffb5eebbb323 65862-041 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-042_176375e4-f8bc-460a-88d3-ffb5eebbb323 65862-042 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060222 ANDA ANDA077622 Aurobindo Pharma Limited LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-043_0fbba1a2-93f0-4140-86c7-53ac9c89e4d1 65862-043 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060314 ANDA ANDA077606 Aurobindo Pharma Limited LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-044_0fbba1a2-93f0-4140-86c7-53ac9c89e4d1 65862-044 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060314 ANDA ANDA077606 Aurobindo Pharma Limited LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-045_0fbba1a2-93f0-4140-86c7-53ac9c89e4d1 65862-045 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060314 ANDA ANDA077606 Aurobindo Pharma Limited LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-046_2bc2dece-297b-48e7-a71a-b516ec412fc8 65862-046 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Aurobindo Pharma Limited STAVUDINE 30 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-047_2bc2dece-297b-48e7-a71a-b516ec412fc8 65862-047 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Aurobindo Pharma Limited STAVUDINE 40 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-048_8003122b-0c87-492e-8a2b-6422f65c60d1 65862-048 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine SYRUP ORAL 20050919 ANDA ANDA077268 Aurobindo Pharma Limited ZIDOVUDINE 10 mg/mL Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 65862-050_e3906dd5-1919-46f8-ba1d-9249d33c48c2 65862-050 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aurobindo Pharma Limited SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-051_e3906dd5-1919-46f8-ba1d-9249d33c48c2 65862-051 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aurobindo Pharma Limited SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-052_e3906dd5-1919-46f8-ba1d-9249d33c48c2 65862-052 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aurobindo Pharma Limited SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-053_e3906dd5-1919-46f8-ba1d-9249d33c48c2 65862-053 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aurobindo Pharma Limited SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-054_e3906dd5-1919-46f8-ba1d-9249d33c48c2 65862-054 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 Aurobindo Pharma Limited SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-055_7a0ea0e5-6921-4185-85f0-c1a97f1d0f52 65862-055 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine SOLUTION ORAL 20161121 ANDA ANDA077695 Aurobindo Pharma Limited LAMIVUDINE 10 mg/mL Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-057_b91b28f6-aab6-40fe-a507-b5df6110d1a9 65862-057 HUMAN PRESCRIPTION DRUG Nevirapine Nevirapine SUSPENSION ORAL 20120522 ANDA ANDA077702 Aurobindo Pharma Limited NEVIRAPINE HEMIHYDRATE 50 mg/5mL Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 65862-058_7d590fec-07d7-45ee-9159-b6a69bdf305e 65862-058 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Aurobindo Pharma Limited FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 65862-059_7d590fec-07d7-45ee-9159-b6a69bdf305e 65862-059 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Aurobindo Pharma Limited FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 65862-060_7d590fec-07d7-45ee-9159-b6a69bdf305e 65862-060 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Aurobindo Pharma Limited FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 65862-061_7d590fec-07d7-45ee-9159-b6a69bdf305e 65862-061 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20081007 ANDA ANDA077731 Aurobindo Pharma Limited FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 65862-062_a64410ed-b814-4cb5-9756-8b0ca4111fed 65862-062 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Aurobindo Pharma Limited METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65862-063_a64410ed-b814-4cb5-9756-8b0ca4111fed 65862-063 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Aurobindo Pharma Limited METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65862-064_a64410ed-b814-4cb5-9756-8b0ca4111fed 65862-064 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Aurobindo Pharma Limited METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65862-068_223a1c89-3000-4d16-b809-ce4a9ee87ea8 65862-068 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 Aurobindo Pharma Limited CEFPROZIL 250 mg/1 N 20181231 65862-069_223a1c89-3000-4d16-b809-ce4a9ee87ea8 65862-069 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 Aurobindo Pharma Limited CEFPROZIL 500 mg/1 N 20181231 65862-070_4663fa25-2fc6-4a12-a9af-77284ee8264e 65862-070 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Aurobindo Pharma Limited AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 65862-071_4663fa25-2fc6-4a12-a9af-77284ee8264e 65862-071 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 Aurobindo Pharma Limited AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 65862-073_adb069ba-d589-4745-aaa9-f2b479f29b9b 65862-073 HUMAN PRESCRIPTION DRUG Abacavir Abacavir TABLET, FILM COATED ORAL 20121217 ANDA ANDA077844 Aurobindo Pharma Limited ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-074_7defac11-2171-4516-847d-96cd724abece 65862-074 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide SOLUTION ORAL 20060828 ANDA ANDA077812 Aurobindo Pharma Limited CITALOPRAM HYDROBROMIDE 10 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-076_47f56462-ca05-461c-9d26-2f82fdb84c5e 65862-076 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 Aurobindo Pharma Limited CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 65862-077_47f56462-ca05-461c-9d26-2f82fdb84c5e 65862-077 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 Aurobindo Pharma Limited CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 65862-078_47f56462-ca05-461c-9d26-2f82fdb84c5e 65862-078 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 Aurobindo Pharma Limited CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 65862-079_636c2e69-1973-4a85-b740-612811cff174 65862-079 HUMAN PRESCRIPTION DRUG Terbinafine Terbinafine Hydrochloride TABLET ORAL 20070702 ANDA ANDA078297 Aurobindo Pharma Limited TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 65862-080_4dcde15f-702a-45b3-9352-a4610851b70c 65862-080 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Aurobindo Pharma Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65862-081_4dcde15f-702a-45b3-9352-a4610851b70c 65862-081 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Aurobindo Pharma Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65862-082_4dcde15f-702a-45b3-9352-a4610851b70c 65862-082 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Aurobindo Pharma Limited GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65862-083_6eb4fca8-f5f4-4a2a-8a00-34df2bd0dd0a 65862-083 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20130425 ANDA ANDA065349 Aurobindo Pharma Limited CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-084_6eb4fca8-f5f4-4a2a-8a00-34df2bd0dd0a 65862-084 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20130425 ANDA ANDA065349 Aurobindo Pharma Limited CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-085_24c72c49-0e6a-4605-b96e-a4a05fd26a7e 65862-085 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070125 ANDA ANDA065352 Aurobindo Pharma Limited CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-086_efc78ef3-d9d2-4603-aea3-1520fd5d2534 65862-086 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20061227 ANDA ANDA077910 Aurobindo Pharma Limited BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65862-087_efc78ef3-d9d2-4603-aea3-1520fd5d2534 65862-087 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol Fumarate TABLET, FILM COATED ORAL 20061227 ANDA ANDA077910 Aurobindo Pharma Limited BISOPROLOL FUMARATE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65862-095_73ee9334-2f7f-4abd-a01a-c7011646615a 65862-095 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 Aurobindo Pharma Limited CEFPODOXIME PROXETIL 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-096_73ee9334-2f7f-4abd-a01a-c7011646615a 65862-096 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 Aurobindo Pharma Limited CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-097_cf47178c-d4ed-41fb-bf3f-123f4302d59f 65862-097 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20061002 ANDA ANDA078008 Aurobindo Pharma Limited MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65862-098_cf47178c-d4ed-41fb-bf3f-123f4302d59f 65862-098 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20061002 ANDA ANDA078008 Aurobindo Pharma Limited MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65862-099_354e8421-1b1e-449c-ab45-2b693e13df3e 65862-099 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070130 ANDA ANDA065381 Aurobindo Pharma Limited CEFPROZIL 125 mg/5mL N 20181231 65862-100_354e8421-1b1e-449c-ab45-2b693e13df3e 65862-100 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20070130 ANDA ANDA065381 Aurobindo Pharma Limited CEFPROZIL 250 mg/5mL N 20181231 65862-101_ba09026d-5f54-4fbf-99c5-0970b9c89c28 65862-101 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070717 ANDA ANDA078021 Aurobindo Pharma Limited AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65862-102_ba09026d-5f54-4fbf-99c5-0970b9c89c28 65862-102 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070717 ANDA ANDA078021 Aurobindo Pharma Limited AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65862-103_ba09026d-5f54-4fbf-99c5-0970b9c89c28 65862-103 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070717 ANDA ANDA078021 Aurobindo Pharma Limited AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65862-104_fdf810f1-b67c-419e-9716-0da505ab85ee 65862-104 HUMAN PRESCRIPTION DRUG Efavirenz Efavirenz CAPSULE ORAL 20171215 ANDA ANDA078064 Aurobindo Pharma Limited EFAVIRENZ 50 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 65862-105_fdf810f1-b67c-419e-9716-0da505ab85ee 65862-105 HUMAN PRESCRIPTION DRUG Efavirenz Efavirenz CAPSULE ORAL 20171215 ANDA ANDA078064 Aurobindo Pharma Limited EFAVIRENZ 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 65862-106_fdf810f1-b67c-419e-9716-0da505ab85ee 65862-106 HUMAN PRESCRIPTION DRUG Efavirenz Efavirenz CAPSULE ORAL 20171215 ANDA ANDA078064 Aurobindo Pharma Limited EFAVIRENZ 200 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 65862-107_d89952ec-4bd4-46db-8ada-a9db93ca3a39 65862-107 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine CAPSULE ORAL 20060327 ANDA ANDA078128 Aurobindo Pharma Limited ZIDOVUDINE 100 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-111_2bc2dece-297b-48e7-a71a-b516ec412fc8 65862-111 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Aurobindo Pharma Limited STAVUDINE 15 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-112_2bc2dece-297b-48e7-a71a-b516ec412fc8 65862-112 HUMAN PRESCRIPTION DRUG Stavudine Stavudine CAPSULE ORAL 20081229 ANDA ANDA077672 Aurobindo Pharma Limited STAVUDINE 20 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-113_f92e2c9e-6b36-42ff-965e-9c22094fc89f 65862-113 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20070919 ANDA ANDA078164 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-116_3008be17-8f9a-4a04-bfa1-d4b51694a23c 65862-116 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20080522 ANDA ANDA078212 Aurobindo Pharma Limited BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65862-117_3008be17-8f9a-4a04-bfa1-d4b51694a23c 65862-117 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20080522 ANDA ANDA078212 Aurobindo Pharma Limited BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65862-118_3008be17-8f9a-4a04-bfa1-d4b51694a23c 65862-118 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20080522 ANDA ANDA078212 Aurobindo Pharma Limited BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65862-119_f7ae9076-ff80-4ec0-868b-cbfef150742b 65862-119 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Aurobindo Pharma Limited RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-120_f7ae9076-ff80-4ec0-868b-cbfef150742b 65862-120 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Aurobindo Pharma Limited RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-121_f7ae9076-ff80-4ec0-868b-cbfef150742b 65862-121 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Aurobindo Pharma Limited RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-122_f7ae9076-ff80-4ec0-868b-cbfef150742b 65862-122 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Aurobindo Pharma Limited RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-123_f7ae9076-ff80-4ec0-868b-cbfef150742b 65862-123 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Aurobindo Pharma Limited RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-124_f7ae9076-ff80-4ec0-868b-cbfef150742b 65862-124 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081008 ANDA ANDA078269 Aurobindo Pharma Limited RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-125_d7c4d79d-e650-4681-b3b2-0a6f84013d84 65862-125 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Aurobindo Pharma Limited TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 65862-126_d7c4d79d-e650-4681-b3b2-0a6f84013d84 65862-126 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Aurobindo Pharma Limited TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 65862-127_d7c4d79d-e650-4681-b3b2-0a6f84013d84 65862-127 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Aurobindo Pharma Limited TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 65862-128_d7c4d79d-e650-4681-b3b2-0a6f84013d84 65862-128 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Aurobindo Pharma Limited TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 65862-133_cad9459d-3a05-469b-87df-a01974575b3d 65862-133 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070720 ANDA ANDA040780 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-134_cad9459d-3a05-469b-87df-a01974575b3d 65862-134 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070720 ANDA ANDA040780 Aurobindo Pharma Limited HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-140_4194738a-f0e0-4f19-926d-90f8e56539d8 65862-140 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20070608 ANDA ANDA065409 Aurobindo Pharma Limited CEFPODOXIME PROXETIL 50 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-141_4194738a-f0e0-4f19-926d-90f8e56539d8 65862-141 HUMAN PRESCRIPTION DRUG Cefpodoxime Proxetil Cefpodoxime Proxetil GRANULE, FOR SUSPENSION ORAL 20070608 ANDA ANDA065409 Aurobindo Pharma Limited CEFPODOXIME PROXETIL 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-142_64730609-9a3d-478d-8526-2e7115337895 65862-142 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aurobindo Pharma Limited CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 65862-143_64730609-9a3d-478d-8526-2e7115337895 65862-143 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aurobindo Pharma Limited CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 65862-144_64730609-9a3d-478d-8526-2e7115337895 65862-144 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aurobindo Pharma Limited CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 65862-145_64730609-9a3d-478d-8526-2e7115337895 65862-145 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Aurobindo Pharma Limited CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 65862-146_5564bb58-23ab-4095-915d-a3232ae39bfe 65862-146 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65862-146_57510ffd-33cc-4532-bc2a-877a784b015c 65862-146 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65862-147_5564bb58-23ab-4095-915d-a3232ae39bfe 65862-147 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65862-147_57510ffd-33cc-4532-bc2a-877a784b015c 65862-147 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65862-148_5564bb58-23ab-4095-915d-a3232ae39bfe 65862-148 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65862-148_57510ffd-33cc-4532-bc2a-877a784b015c 65862-148 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 Aurobindo Pharma Limited SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65862-149_ca5b3f1f-8c5d-4a34-b04e-102684a1fa53 65862-149 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20071030 ANDA ANDA078341 Aurobindo Pharma Limited FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 65862-154_31208c06-8448-4cd7-9ba5-81a7f370630a 65862-154 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Aurobindo Pharma Limited PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-155_31208c06-8448-4cd7-9ba5-81a7f370630a 65862-155 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Aurobindo Pharma Limited PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-156_31208c06-8448-4cd7-9ba5-81a7f370630a 65862-156 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Aurobindo Pharma Limited PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-157_31208c06-8448-4cd7-9ba5-81a7f370630a 65862-157 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Aurobindo Pharma Limited PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-158_478f84fb-118e-4576-9989-94ad53fce9ca 65862-158 HUMAN PRESCRIPTION DRUG carisoprodol carisoprodol TABLET ORAL 20090806 ANDA ANDA040792 Aurobindo Pharma Limited CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 65862-159_1aa143ca-3a86-4eca-bcc5-5fd00752d319 65862-159 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070504 ANDA ANDA078413 Aurobindo Pharma Limited ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 65862-160_1aa143ca-3a86-4eca-bcc5-5fd00752d319 65862-160 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070504 ANDA ANDA078413 Aurobindo Pharma Limited ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 65862-161_f14222e5-3d6d-4bef-8df8-e484f86938cc 65862-161 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride/Hydrochlorothiazide Quinapril Hydrochloride/Hydrochlorothiazide TABLET, FILM COATED ORAL 20070824 ANDA ANDA078450 Aurobindo Pharma Limited QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-162_f14222e5-3d6d-4bef-8df8-e484f86938cc 65862-162 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride/Hydrochlorothiazide Quinapril Hydrochloride/Hydrochlorothiazide TABLET, FILM COATED ORAL 20070824 ANDA ANDA078450 Aurobindo Pharma Limited QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-163_f14222e5-3d6d-4bef-8df8-e484f86938cc 65862-163 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride/Hydrochlorothiazide Quinapril Hydrochloride/Hydrochlorothiazide TABLET, FILM COATED ORAL 20070824 ANDA ANDA078450 Aurobindo Pharma Limited QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-164_18eed6f4-0d6f-4d30-9e3b-ba2ba1686614 65862-164 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA078438 Aurobindo Pharma Limited TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-165_18eed6f4-0d6f-4d30-9e3b-ba2ba1686614 65862-165 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA078438 Aurobindo Pharma Limited TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-166_18eed6f4-0d6f-4d30-9e3b-ba2ba1686614 65862-166 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070612 ANDA ANDA078438 Aurobindo Pharma Limited TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-168_91cc8489-d129-4ba8-b42c-cb7842d92269 65862-168 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071031 ANDA ANDA078512 Aurobindo Pharma Limited ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65862-169_91cc8489-d129-4ba8-b42c-cb7842d92269 65862-169 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071031 ANDA ANDA078512 Aurobindo Pharma Limited ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65862-170_91cc8489-d129-4ba8-b42c-cb7842d92269 65862-170 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071031 ANDA ANDA078512 Aurobindo Pharma Limited ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 65862-171_cd61c6cc-9f68-44e3-994e-f13a46110161 65862-171 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078462 Aurobindo Pharma Limited TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65862-172_cd61c6cc-9f68-44e3-994e-f13a46110161 65862-172 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078462 Aurobindo Pharma Limited TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65862-173_cd61c6cc-9f68-44e3-994e-f13a46110161 65862-173 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078462 Aurobindo Pharma Limited TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65862-174_cd61c6cc-9f68-44e3-994e-f13a46110161 65862-174 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078462 Aurobindo Pharma Limited TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65862-175_bd8dfa32-75cc-4ecc-9df3-f077fbaef119 65862-175 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Aurobindo Pharma Limited PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 65862-176_bd8dfa32-75cc-4ecc-9df3-f077fbaef119 65862-176 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 Aurobindo Pharma Limited PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 65862-177_ab7315fd-e186-4a28-9475-55c2ec12a9dc 65862-177 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107 ANDA ANDA065434 Aurobindo Pharma Limited CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-185_412c6015-45ec-4abb-a43b-6abaf5bc7fc5 65862-185 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 Aurobindo Pharma Limited CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 65862-185_f2acde28-06b9-4e72-98d4-b65afc57e3eb 65862-185 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 Aurobindo Pharma Limited CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 65862-186_412c6015-45ec-4abb-a43b-6abaf5bc7fc5 65862-186 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 Aurobindo Pharma Limited CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 65862-186_f2acde28-06b9-4e72-98d4-b65afc57e3eb 65862-186 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 Aurobindo Pharma Limited CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 65862-187_e2f24d94-1273-4ccc-b976-3095a671c29b 65862-187 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Aurobindo Pharma Limited ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 65862-188_e2f24d94-1273-4ccc-b976-3095a671c29b 65862-188 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Aurobindo Pharma Limited ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 65862-189_e2f24d94-1273-4ccc-b976-3095a671c29b 65862-189 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Aurobindo Pharma Limited ONDANSETRON HYDROCHLORIDE 24 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 65862-190_62700754-4b64-421a-89dd-736867287197 65862-190 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20080926 ANDA ANDA078643 Aurobindo Pharma Limited CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 65862-191_62700754-4b64-421a-89dd-736867287197 65862-191 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20080926 ANDA ANDA078643 Aurobindo Pharma Limited CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 65862-192_d5229538-dff2-4f71-ba62-342ffe8d4556 65862-192 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Aurobindo Pharma Limited FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-193_d5229538-dff2-4f71-ba62-342ffe8d4556 65862-193 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Aurobindo Pharma Limited FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-194_d5229538-dff2-4f71-ba62-342ffe8d4556 65862-194 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Aurobindo Pharma Limited FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-198_c0a52319-8484-4bf9-a9fb-08dac12fc709 65862-198 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Aurobindo Pharma Limited GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65862-199_c0a52319-8484-4bf9-a9fb-08dac12fc709 65862-199 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Aurobindo Pharma Limited GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65862-200_c0a52319-8484-4bf9-a9fb-08dac12fc709 65862-200 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 Aurobindo Pharma Limited GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65862-201_55f6eacb-c96d-4e6a-b955-55e575810c6c 65862-201 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA090083 Aurobindo Pharma Limited LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 65862-202_55f6eacb-c96d-4e6a-b955-55e575810c6c 65862-202 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA090083 Aurobindo Pharma Limited LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 65862-203_55f6eacb-c96d-4e6a-b955-55e575810c6c 65862-203 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA090083 Aurobindo Pharma Limited LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 65862-207_6e369666-80af-46ef-8254-72f535bdcf01 65862-207 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20090917 ANDA ANDA079111 Aurobindo Pharma Limited RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 65862-207_f0ee925d-fab9-49dd-8eb0-719ff2887531 65862-207 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20090917 ANDA ANDA079111 Aurobindo Pharma Limited RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 65862-208_07b11b99-2774-4755-9ebe-ec5df1906753 65862-208 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride SOLUTION ORAL 20071128 ANDA ANDA078776 Aurobindo Pharma Limited ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 65862-209_366a4c4b-575e-4958-8943-abfed1cca478 65862-209 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20080311 ANDA ANDA065470 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 65862-210_366a4c4b-575e-4958-8943-abfed1cca478 65862-210 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20080311 ANDA ANDA065470 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 65862-211_366a4c4b-575e-4958-8943-abfed1cca478 65862-211 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20080311 ANDA ANDA065470 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 65862-214_942ff200-91e2-4140-b719-8f73d5f577a4 65862-214 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080606 ANDA ANDA078829 Aurobindo Pharma Limited ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 65862-215_942ff200-91e2-4140-b719-8f73d5f577a4 65862-215 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20080606 ANDA ANDA078829 Aurobindo Pharma Limited ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20181231 65862-218_53a3f56a-cd3c-4cf2-b792-532783de6d33 65862-218 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 Aurobindo Pharma Limited CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 65862-219_53a3f56a-cd3c-4cf2-b792-532783de6d33 65862-219 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20071214 ANDA ANDA065473 Aurobindo Pharma Limited CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 65862-224_c2e86367-b88f-46be-941b-2ac5272acef6 65862-224 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride SOLUTION, CONCENTRATE ORAL 20081031 ANDA ANDA078861 Aurobindo Pharma Limited SERTRALINE HYDROCHLORIDE 20 mg/mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-225_40930f22-a9e5-4d2e-8e41-ae66188338df 65862-225 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20120725 ANDA ANDA065489 Aurobindo Pharma Limited CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 65862-226_40930f22-a9e5-4d2e-8e41-ae66188338df 65862-226 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20120725 ANDA ANDA065489 Aurobindo Pharma Limited CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 65862-227_153576b4-2532-4625-9312-5b290b50c6f5 65862-227 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078956 Aurobindo Pharma Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65862-228_153576b4-2532-4625-9312-5b290b50c6f5 65862-228 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078956 Aurobindo Pharma Limited LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65862-229_153576b4-2532-4625-9312-5b290b50c6f5 65862-229 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078956 Aurobindo Pharma Limited LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65862-230_153576b4-2532-4625-9312-5b290b50c6f5 65862-230 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA078956 Aurobindo Pharma Limited LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65862-237_0f951c63-1f7a-4224-ba0b-b59123c13e85 65862-237 HUMAN PRESCRIPTION DRUG Ibandronate Sodium Ibandronate Sodium TABLET, FILM COATED ORAL 20160311 ANDA ANDA204502 Aurobindo Pharma Limited IBANDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 65862-238_a147b5f4-ac0e-46a8-b282-1626bffeadc5 65862-238 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Aurobindo Pharma Limited ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65862-239_a147b5f4-ac0e-46a8-b282-1626bffeadc5 65862-239 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Aurobindo Pharma Limited ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65862-240_a147b5f4-ac0e-46a8-b282-1626bffeadc5 65862-240 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Aurobindo Pharma Limited ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65862-241_a147b5f4-ac0e-46a8-b282-1626bffeadc5 65862-241 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Aurobindo Pharma Limited ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65862-242_a147b5f4-ac0e-46a8-b282-1626bffeadc5 65862-242 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Aurobindo Pharma Limited ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65862-243_a147b5f4-ac0e-46a8-b282-1626bffeadc5 65862-243 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Aurobindo Pharma Limited ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65862-244_a147b5f4-ac0e-46a8-b282-1626bffeadc5 65862-244 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079016 Aurobindo Pharma Limited ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 65862-245_87f0a4e2-497c-4310-896b-2aee6b1816eb 65862-245 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Aurobindo Pharma Limited LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65862-246_87f0a4e2-497c-4310-896b-2aee6b1816eb 65862-246 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Aurobindo Pharma Limited LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65862-247_87f0a4e2-497c-4310-896b-2aee6b1816eb 65862-247 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Aurobindo Pharma Limited LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65862-248_5bb6243d-8041-4f3a-b9a9-45b6bfd8bf3e 65862-248 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate SOLUTION ORAL 20120403 ANDA ANDA079062 Aurobindo Pharma Limited ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-249_4fec2752-ffac-4cbb-90ae-d435c7225239 65862-249 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride Alfuzosin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120830 ANDA ANDA079060 Aurobindo Pharma Limited ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 65862-250_43fd634c-aa6e-4cd3-90f2-93021fff2c64 65862-250 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20090115 ANDA ANDA079063 Aurobindo Pharma Limited LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65862-286_81a04c71-787a-4bd6-90e6-1aa4baacad1a 65862-286 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA079070 Aurobindo Pharma Limited PERINDOPRIL ERBUMINE 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-286_d9033965-7cf5-41ef-9efa-d2eec745b43d 65862-286 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA079070 Aurobindo Pharma Limited PERINDOPRIL ERBUMINE 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-287_81a04c71-787a-4bd6-90e6-1aa4baacad1a 65862-287 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA079070 Aurobindo Pharma Limited PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-287_d9033965-7cf5-41ef-9efa-d2eec745b43d 65862-287 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA079070 Aurobindo Pharma Limited PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-288_81a04c71-787a-4bd6-90e6-1aa4baacad1a 65862-288 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA079070 Aurobindo Pharma Limited PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-288_d9033965-7cf5-41ef-9efa-d2eec745b43d 65862-288 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20091110 ANDA ANDA079070 Aurobindo Pharma Limited PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-290_457e58ea-af2f-4356-9c67-fc692c9cdf52 65862-290 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20090917 ANDA ANDA079117 Aurobindo Pharma Limited RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 65862-290_553bf5c0-4cea-4eed-967b-564d79b11817 65862-290 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20090917 ANDA ANDA079117 Aurobindo Pharma Limited RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 65862-291_665427de-639b-41c6-b2ef-ab434d30c0f2 65862-291 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120720 ANDA ANDA079118 Aurobindo Pharma Limited METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65862-292_665427de-639b-41c6-b2ef-ab434d30c0f2 65862-292 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120720 ANDA ANDA079118 Aurobindo Pharma Limited METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65862-293_ad382231-b48f-4bb9-906b-cfeada72fe40 65862-293 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Aurobindo Pharma Limited ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-294_ad382231-b48f-4bb9-906b-cfeada72fe40 65862-294 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Aurobindo Pharma Limited ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-295_ad382231-b48f-4bb9-906b-cfeada72fe40 65862-295 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Aurobindo Pharma Limited ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-296_ad382231-b48f-4bb9-906b-cfeada72fe40 65862-296 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Aurobindo Pharma Limited ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-299_ad47b6be-8be9-4399-ab8d-dff04d2e041a 65862-299 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20090918 ANDA ANDA079150 Aurobindo Pharma Limited FLUCONAZOLE 10 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 65862-300_ad47b6be-8be9-4399-ab8d-dff04d2e041a 65862-300 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole POWDER, FOR SUSPENSION ORAL 20090918 ANDA ANDA079150 Aurobindo Pharma Limited FLUCONAZOLE 40 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 65862-306_14e356b3-c110-4956-9f0a-479e3ccdc33b 65862-306 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine SOLUTION ORAL 20090319 ANDA ANDA079209 Aurobindo Pharma Limited FLUOXETINE HYDROCHLORIDE 20 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-308_6a77c6bd-7369-460e-b9cf-ad920eddd2b2 65862-308 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA079245 Aurobindo Pharma Limited FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-309_6a77c6bd-7369-460e-b9cf-ad920eddd2b2 65862-309 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA079245 Aurobindo Pharma Limited FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-310_d065d7cf-bc3e-4c46-b63c-2544c8d25b6d 65862-310 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE ORAL 20080924 ANDA ANDA090094 Aurobindo Pharma Limited DIDANOSINE 125 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-311_d065d7cf-bc3e-4c46-b63c-2544c8d25b6d 65862-311 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE ORAL 20080924 ANDA ANDA090094 Aurobindo Pharma Limited DIDANOSINE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-312_d065d7cf-bc3e-4c46-b63c-2544c8d25b6d 65862-312 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE ORAL 20080924 ANDA ANDA090094 Aurobindo Pharma Limited DIDANOSINE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-313_d065d7cf-bc3e-4c46-b63c-2544c8d25b6d 65862-313 HUMAN PRESCRIPTION DRUG Didanosine Didanosine CAPSULE, DELAYED RELEASE ORAL 20080924 ANDA ANDA090094 Aurobindo Pharma Limited DIDANOSINE 400 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-315_87f0a4e2-497c-4310-896b-2aee6b1816eb 65862-315 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Aurobindo Pharma Limited LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65862-325_520cdba1-45ab-4901-9f27-3523daf3189d 65862-325 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090056 Aurobindo Pharma Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65862-326_520cdba1-45ab-4901-9f27-3523daf3189d 65862-326 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110531 ANDA ANDA090056 Aurobindo Pharma Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65862-327_76201b82-f7bc-40e5-8ec6-fa3d9f27a427 65862-327 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 Aurobindo Pharma Limited ALENDRONATE SODIUM 10 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 65862-328_76201b82-f7bc-40e5-8ec6-fa3d9f27a427 65862-328 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 Aurobindo Pharma Limited ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 65862-329_76201b82-f7bc-40e5-8ec6-fa3d9f27a427 65862-329 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080804 ANDA ANDA090124 Aurobindo Pharma Limited ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 65862-357_170040a9-acdc-4466-862c-78ddb44566dc 65862-357 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 Aurobindo Pharma Limited CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 65862-361_cf0a85ae-6543-43a3-abf2-e471383620c6 65862-361 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20091104 ANDA ANDA090401 Aurobindo Pharma Limited LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65862-362_cf0a85ae-6543-43a3-abf2-e471383620c6 65862-362 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20091104 ANDA ANDA090401 Aurobindo Pharma Limited LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65862-373_1960d3a5-52e9-455e-b45c-5958ebfc7308 65862-373 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 Aurobindo Pharma Limited ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-374_1960d3a5-52e9-455e-b45c-5958ebfc7308 65862-374 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 Aurobindo Pharma Limited ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-375_1960d3a5-52e9-455e-b45c-5958ebfc7308 65862-375 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA090432 Aurobindo Pharma Limited ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-390_511ca50e-fe76-4cab-bae8-fa251bc43a41 65862-390 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Aurobindo Pharma Limited ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 65862-391_511ca50e-fe76-4cab-bae8-fa251bc43a41 65862-391 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Aurobindo Pharma Limited ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 65862-402_74c2e1d3-3ed8-4c43-9983-d8326b3111ee 65862-402 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110421 ANDA ANDA090554 Aurobindo Pharma Limited DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65862-403_74c2e1d3-3ed8-4c43-9983-d8326b3111ee 65862-403 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110421 ANDA ANDA090554 Aurobindo Pharma Limited DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65862-404_be24919a-c26a-4250-a325-0279e759a07e 65862-404 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-405_be24919a-c26a-4250-a325-0279e759a07e 65862-405 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-406_be24919a-c26a-4250-a325-0279e759a07e 65862-406 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-407_be24919a-c26a-4250-a325-0279e759a07e 65862-407 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-408_be24919a-c26a-4250-a325-0279e759a07e 65862-408 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20100407 ANDA ANDA090555 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 65862-419_1183c243-7184-4bf9-bda2-a276af5f1439 65862-419 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 65862-419_e90faa5a-408f-424d-afed-3e18a2444386 65862-419 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 65862-420_1183c243-7184-4bf9-bda2-a276af5f1439 65862-420 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 65862-420_e90faa5a-408f-424d-afed-3e18a2444386 65862-420 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 65862-421_dd6e612f-39e2-4222-a0c7-d21faea18890 65862-421 HUMAN PRESCRIPTION DRUG Tenofovir Disoproxil Fumarate Tenofovir Disoproxil Fumarate TABLET, FILM COATED ORAL 20180126 ANDA ANDA090647 Aurobindo Pharma Limited TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 65862-422_7c93cda5-d5c5-45af-b5cd-cdb63870808a 65862-422 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Allergy Cetirizine Hydrochloride SOLUTION ORAL 20100202 ANDA ANDA090750 Aurobindo Pharma Limited CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 65862-431_b4cf6038-8de3-4b46-9b9f-1c6ec445bd20 65862-431 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine Hydrochloride SYRUP ORAL 20100728 ANDA ANDA090623 Aurobindo Pharma Limited RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 65862-443_2474de7e-aff1-473e-9adf-8ec07b5a3dc1 65862-443 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Hives Relief Cetirizine Hydrochloride SOLUTION ORAL 20100202 ANDA ANDA090750 Aurobindo Pharma Limited CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 65862-448_b116863c-75b3-45d5-8013-a28211c799bd 65862-448 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Aurobindo Pharma Limited VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 65862-449_b116863c-75b3-45d5-8013-a28211c799bd 65862-449 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 Aurobindo Pharma Limited VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 65862-451_b5add72b-5904-4d55-ad28-b8ef95191653 65862-451 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Aurobindo Pharma Limited DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-452_b5add72b-5904-4d55-ad28-b8ef95191653 65862-452 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Aurobindo Pharma Limited DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-453_b5add72b-5904-4d55-ad28-b8ef95191653 65862-453 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Aurobindo Pharma Limited DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-454_e50163ae-7b19-4aeb-8556-4d898552903c 65862-454 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20110607 ANDA ANDA090871 Aurobindo Pharma Limited ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65862-455_e50163ae-7b19-4aeb-8556-4d898552903c 65862-455 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20110607 ANDA ANDA090871 Aurobindo Pharma Limited ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65862-456_e50163ae-7b19-4aeb-8556-4d898552903c 65862-456 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20110607 ANDA ANDA090871 Aurobindo Pharma Limited ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65862-457_e50163ae-7b19-4aeb-8556-4d898552903c 65862-457 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20110607 ANDA ANDA090871 Aurobindo Pharma Limited ALPRAZOLAM 3 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65862-458_d2a35f84-768b-45cf-860b-573dd7da9064 65862-458 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 Aurobindo Pharma Limited GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65862-459_d2a35f84-768b-45cf-860b-573dd7da9064 65862-459 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 Aurobindo Pharma Limited GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65862-460_d2a35f84-768b-45cf-860b-573dd7da9064 65862-460 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20110329 ANDA ANDA090957 Aurobindo Pharma Limited GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65862-465_eeff6372-6ca1-47eb-9685-fa43bbbdc604 65862-465 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 Aurobindo Pharma Limited FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 65862-466_eeff6372-6ca1-47eb-9685-fa43bbbdc604 65862-466 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 Aurobindo Pharma Limited FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 65862-467_eeff6372-6ca1-47eb-9685-fa43bbbdc604 65862-467 HUMAN PRESCRIPTION DRUG Famciclovir Famciclovir TABLET, FILM COATED ORAL 20110321 ANDA ANDA091114 Aurobindo Pharma Limited FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 65862-468_c4f65e5a-a153-42d0-a590-00ed0034993f 65862-468 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Aurobindo Pharma Limited LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-469_c4f65e5a-a153-42d0-a590-00ed0034993f 65862-469 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Aurobindo Pharma Limited LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-470_c4f65e5a-a153-42d0-a590-00ed0034993f 65862-470 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Aurobindo Pharma Limited LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-471_b1c86ca7-9169-43a3-b167-214bb5306f29 65862-471 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20110330 ANDA ANDA091163 Aurobindo Pharma Limited FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-472_b1c86ca7-9169-43a3-b167-214bb5306f29 65862-472 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20110330 ANDA ANDA091163 Aurobindo Pharma Limited FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-473_b1c86ca7-9169-43a3-b167-214bb5306f29 65862-473 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20110330 ANDA ANDA091163 Aurobindo Pharma Limited FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-474_9cfec1ea-eb08-47b6-a65f-b52dad5c6cfa 65862-474 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Aurobindo Pharma Limited RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-475_9cfec1ea-eb08-47b6-a65f-b52dad5c6cfa 65862-475 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Aurobindo Pharma Limited RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-476_9cfec1ea-eb08-47b6-a65f-b52dad5c6cfa 65862-476 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Aurobindo Pharma Limited RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-477_9cfec1ea-eb08-47b6-a65f-b52dad5c6cfa 65862-477 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Aurobindo Pharma Limited RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-489_a5772b4e-baf6-49dc-9825-4a9159fbe3ec 65862-489 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-490_a5772b4e-baf6-49dc-9825-4a9159fbe3ec 65862-490 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-491_a5772b4e-baf6-49dc-9825-4a9159fbe3ec 65862-491 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-492_a5772b4e-baf6-49dc-9825-4a9159fbe3ec 65862-492 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-493_a5772b4e-baf6-49dc-9825-4a9159fbe3ec 65862-493 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-494_a5772b4e-baf6-49dc-9825-4a9159fbe3ec 65862-494 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-495_a5772b4e-baf6-49dc-9825-4a9159fbe3ec 65862-495 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA091388 Aurobindo Pharma Limited QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-496_340c8706-8d9e-446d-b8a7-72699dc97737 65862-496 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20100608 ANDA ANDA091348 Aurobindo Pharma Limited SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 65862-501_80d65ee7-6ede-47eb-bed3-519d2dc63248 65862-501 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091569 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 65862-502_80d65ee7-6ede-47eb-bed3-519d2dc63248 65862-502 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091569 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 65862-503_80d65ee7-6ede-47eb-bed3-519d2dc63248 65862-503 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120120 ANDA ANDA091568 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 65862-512_e89a359f-27d2-4a9b-acf5-d21b2e3a2531 65862-512 HUMAN PRESCRIPTION DRUG PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 Aurobindo Pharma Limited PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 65862-513_e89a359f-27d2-4a9b-acf5-d21b2e3a2531 65862-513 HUMAN PRESCRIPTION DRUG PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 Aurobindo Pharma Limited PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 65862-514_e89a359f-27d2-4a9b-acf5-d21b2e3a2531 65862-514 HUMAN PRESCRIPTION DRUG PIOGLITAZONE HYDROCHLORIDE pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200268 Aurobindo Pharma Limited PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 65862-515_8b643b57-8af1-423d-a26b-d35fea04b9b5 65862-515 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20111031 ANDA ANDA200629 Aurobindo Pharma Limited NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65862-516_8b643b57-8af1-423d-a26b-d35fea04b9b5 65862-516 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20111031 ANDA ANDA200629 Aurobindo Pharma Limited NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65862-517_92e469fb-1a23-46f9-beb3-f89b404e5373 65862-517 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20151130 ANDA ANDA200296 Aurobindo Pharma Limited RISEDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 65862-518_92e469fb-1a23-46f9-beb3-f89b404e5373 65862-518 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20151130 ANDA ANDA200296 Aurobindo Pharma Limited RISEDRONATE SODIUM 30 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 65862-519_92e469fb-1a23-46f9-beb3-f89b404e5373 65862-519 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20151130 ANDA ANDA200296 Aurobindo Pharma Limited RISEDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 65862-520_2e142ec8-81c9-4aeb-8f13-9d8ba956820a 65862-520 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20111108 ANDA ANDA200429 Aurobindo Pharma Limited NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65862-521_2e142ec8-81c9-4aeb-8f13-9d8ba956820a 65862-521 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20111108 ANDA ANDA200429 Aurobindo Pharma Limited NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65862-522_2e142ec8-81c9-4aeb-8f13-9d8ba956820a 65862-522 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20111108 ANDA ANDA200429 Aurobindo Pharma Limited NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65862-523_602bee19-5fa2-49ff-82d7-bdaa740e9e46 65862-523 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 Aurobindo Pharma Limited GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65862-524_602bee19-5fa2-49ff-82d7-bdaa740e9e46 65862-524 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111006 ANDA ANDA200651 Aurobindo Pharma Limited GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 65862-525_989bccec-a1de-4e78-814b-053ea842ba16 65862-525 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride and Metformin Hydrochloride Pioglitazone Hydrochloride and Metformin Hydrochloride TABLET, FILM COATED ORAL 20130213 ANDA ANDA200823 Aurobindo Pharma Limited PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 500 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65862-526_989bccec-a1de-4e78-814b-053ea842ba16 65862-526 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride and Metformin Hydrochloride Pioglitazone Hydrochloride and Metformin Hydrochloride TABLET, FILM COATED ORAL 20130213 ANDA ANDA200823 Aurobindo Pharma Limited PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 850 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 65862-527_bcfb15c1-e861-485c-9555-4d52ac59d4cb 65862-527 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA200834 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-528_bcfb15c1-e861-485c-9555-4d52ac59d4cb 65862-528 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA200834 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-533_5c8b0d8b-9317-4f13-a748-7504dc60db7d 65862-533 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 65862-534_5c8b0d8b-9317-4f13-a748-7504dc60db7d 65862-534 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 65862-535_53c96d46-6f26-432d-af0d-2ecd18ad922c 65862-535 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201091 Aurobindo Pharma Limited AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 65862-536_affa6a76-8716-4f24-a647-a39d03100991 65862-536 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Aurobindo Pharma Limited LEVOFLOXACIN 250 mg/1 N 20181231 65862-537_affa6a76-8716-4f24-a647-a39d03100991 65862-537 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Aurobindo Pharma Limited LEVOFLOXACIN 500 mg/1 N 20181231 65862-538_affa6a76-8716-4f24-a647-a39d03100991 65862-538 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 Aurobindo Pharma Limited LEVOFLOXACIN 750 mg/1 N 20181231 65862-547_5c5fd9f7-a923-4948-bcff-775b9fa2ed8d 65862-547 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Aurobindo Pharma Limited VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-548_5c5fd9f7-a923-4948-bcff-775b9fa2ed8d 65862-548 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Aurobindo Pharma Limited VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-549_5c5fd9f7-a923-4948-bcff-775b9fa2ed8d 65862-549 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Aurobindo Pharma Limited VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-550_5c5fd9f7-a923-4948-bcff-775b9fa2ed8d 65862-550 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Aurobindo Pharma Limited VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-551_5c5fd9f7-a923-4948-bcff-775b9fa2ed8d 65862-551 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA202519 Aurobindo Pharma Limited VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-552_4f52e096-4c3b-42cc-b131-42bdd65f3e6b 65862-552 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20111117 ANDA ANDA202032 Aurobindo Pharma Limited LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-553_4f52e096-4c3b-42cc-b131-42bdd65f3e6b 65862-553 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20111117 ANDA ANDA202032 Aurobindo Pharma Limited LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-554_7902fe40-154c-45f3-ae2b-f5fe7f02e267 65862-554 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA202261 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE 45 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 65862-556_7902fe40-154c-45f3-ae2b-f5fe7f02e267 65862-556 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA202261 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE 90 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 65862-558_7902fe40-154c-45f3-ae2b-f5fe7f02e267 65862-558 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20121119 ANDA ANDA202261 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 65862-559_6fc44899-c7ed-428f-bf57-b6a33a07ea5f 65862-559 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20120928 ANDA ANDA202038 Aurobindo Pharma Limited PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 65862-560_6fc44899-c7ed-428f-bf57-b6a33a07ea5f 65862-560 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20120928 ANDA ANDA202038 Aurobindo Pharma Limited PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 65862-561_476ad484-239c-4af1-bc2b-a5d1d7df2294 65862-561 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-562_476ad484-239c-4af1-bc2b-a5d1d7df2294 65862-562 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-563_476ad484-239c-4af1-bc2b-a5d1d7df2294 65862-563 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-564_476ad484-239c-4af1-bc2b-a5d1d7df2294 65862-564 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-565_476ad484-239c-4af1-bc2b-a5d1d7df2294 65862-565 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-566_476ad484-239c-4af1-bc2b-a5d1d7df2294 65862-566 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Aurobindo Pharma Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-567_644abdad-667b-42b6-8153-a792988a441d 65862-567 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA202096 Aurobindo Pharma Limited MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 65862-568_644abdad-667b-42b6-8153-a792988a441d 65862-568 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA202096 Aurobindo Pharma Limited MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 65862-570_cf1f0d61-f7c4-43a0-b077-9acce2c2a2a5 65862-570 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA202223 Aurobindo Pharma Limited VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-571_cf1f0d61-f7c4-43a0-b077-9acce2c2a2a5 65862-571 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA202223 Aurobindo Pharma Limited VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-572_cf1f0d61-f7c4-43a0-b077-9acce2c2a2a5 65862-572 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA202223 Aurobindo Pharma Limited VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-573_cf1f0d61-f7c4-43a0-b077-9acce2c2a2a5 65862-573 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA202223 Aurobindo Pharma Limited VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-574_644abdad-667b-42b6-8153-a792988a441d 65862-574 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA202468 Aurobindo Pharma Limited MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 65862-579_b0da3541-caef-4c8a-868c-744152d6ae1f 65862-579 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120629 ANDA ANDA202759 Aurobindo Pharma Limited GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65862-580_b0da3541-caef-4c8a-868c-744152d6ae1f 65862-580 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120629 ANDA ANDA202759 Aurobindo Pharma Limited GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65862-581_b0da3541-caef-4c8a-868c-744152d6ae1f 65862-581 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120629 ANDA ANDA202759 Aurobindo Pharma Limited GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65862-582_c5a00959-df69-4f81-afcd-008a1a413d19 65862-582 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65862-583_c5a00959-df69-4f81-afcd-008a1a413d19 65862-583 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65862-584_c5a00959-df69-4f81-afcd-008a1a413d19 65862-584 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65862-585_c5a00959-df69-4f81-afcd-008a1a413d19 65862-585 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65862-586_c5a00959-df69-4f81-afcd-008a1a413d19 65862-586 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65862-587_c5a00959-df69-4f81-afcd-008a1a413d19 65862-587 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Aurobindo Pharma Limited AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 65862-594_48e0de2d-0ad2-4c50-ba17-6f15f2b431fd 65862-594 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140602 ANDA ANDA202419 Aurobindo Pharma Limited DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65862-595_48e0de2d-0ad2-4c50-ba17-6f15f2b431fd 65862-595 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140602 ANDA ANDA202419 Aurobindo Pharma Limited DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65862-596_5d508ff9-23e7-497e-adbb-f76ef5d1b77c 65862-596 HUMAN PRESCRIPTION DRUG Clindamycin Palmitate Hydrochloride (Pediatric) Clindamycin Palmitate Hydrochloride (Pediatric) SOLUTION ORAL 20130430 ANDA ANDA202409 Aurobindo Pharma Limited CLINDAMYCIN PALMITATE HYDROCHLORIDE 75 mg/5mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 65862-597_3a55c20e-f118-4300-bb57-02a1f01f1131 65862-597 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20120515 ANDA ANDA202418 Aurobindo Pharma Limited LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-598_0a041159-b8b7-458c-8b9c-345c7ad085f4 65862-598 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 Aurobindo Pharma Limited TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 65862-599_e205d467-2d53-4ddc-8c29-4ced6b16401d 65862-599 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA202490 Aurobindo Pharma Limited RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65862-600_e205d467-2d53-4ddc-8c29-4ced6b16401d 65862-600 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20121231 ANDA ANDA202490 Aurobindo Pharma Limited RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65862-601_26d04fa7-7b27-48ee-ab08-ea5eec285e59 65862-601 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120927 ANDA ANDA202566 Aurobindo Pharma Limited MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 65862-602_26d04fa7-7b27-48ee-ab08-ea5eec285e59 65862-602 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20120927 ANDA ANDA202566 Aurobindo Pharma Limited MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 65862-603_94b5b4ee-27c0-4983-b146-eb1144858706 65862-603 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET, FILM COATED ORAL 20140304 ANDA ANDA202632 Aurobindo Pharma Limited MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 65862-604_1bf42109-9a54-4e00-9beb-1cdb66709ec7 65862-604 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Aurobindo Pharma Limited PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65862-605_1bf42109-9a54-4e00-9beb-1cdb66709ec7 65862-605 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Aurobindo Pharma Limited PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65862-606_1bf42109-9a54-4e00-9beb-1cdb66709ec7 65862-606 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Aurobindo Pharma Limited PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65862-607_1bf42109-9a54-4e00-9beb-1cdb66709ec7 65862-607 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Aurobindo Pharma Limited PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65862-608_1bf42109-9a54-4e00-9beb-1cdb66709ec7 65862-608 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Aurobindo Pharma Limited PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65862-609_1bf42109-9a54-4e00-9beb-1cdb66709ec7 65862-609 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20121026 ANDA ANDA202633 Aurobindo Pharma Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 65862-617_bf3a014a-6b9d-4661-a8fd-38be0cda902d 65862-617 HUMAN PRESCRIPTION DRUG Quinapril Quinapril Hydrochloride TABLET, FILM COATED ORAL 20130429 ANDA ANDA202725 Aurobindo Pharma Limited QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-618_bf3a014a-6b9d-4661-a8fd-38be0cda902d 65862-618 HUMAN PRESCRIPTION DRUG Quinapril Quinapril Hydrochloride TABLET, FILM COATED ORAL 20130429 ANDA ANDA202725 Aurobindo Pharma Limited QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-619_bf3a014a-6b9d-4661-a8fd-38be0cda902d 65862-619 HUMAN PRESCRIPTION DRUG Quinapril Quinapril Hydrochloride TABLET, FILM COATED ORAL 20130429 ANDA ANDA202725 Aurobindo Pharma Limited QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-620_bf3a014a-6b9d-4661-a8fd-38be0cda902d 65862-620 HUMAN PRESCRIPTION DRUG Quinapril Quinapril Hydrochloride TABLET, FILM COATED ORAL 20130429 ANDA ANDA202725 Aurobindo Pharma Limited QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 65862-621_e4462df4-f3c7-4078-ad9f-0b486379be88 65862-621 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20171103 ANDA ANDA202821 Aurobindo Pharma Limited FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] N 20181231 65862-622_e4462df4-f3c7-4078-ad9f-0b486379be88 65862-622 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20171103 ANDA ANDA202821 Aurobindo Pharma Limited FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 65862-623_e4462df4-f3c7-4078-ad9f-0b486379be88 65862-623 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20171103 ANDA ANDA202821 Aurobindo Pharma Limited FLECAINIDE ACETATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 65862-624_89e9b0c2-9197-4908-ad01-e90a5d7821c4 65862-624 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20150916 ANDA ANDA202726 Aurobindo Pharma Limited GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 65862-625_8a6d1b28-a225-4dc8-bef9-c186532b1e2a 65862-625 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203062 Aurobindo Pharma Limited RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65862-626_8a6d1b28-a225-4dc8-bef9-c186532b1e2a 65862-626 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA203062 Aurobindo Pharma Limited RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65862-629_1675d27b-d1d8-4024-a140-307046549071 65862-629 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130222 ANDA ANDA203630 Aurobindo Pharma Limited IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-630_1675d27b-d1d8-4024-a140-307046549071 65862-630 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130222 ANDA ANDA203630 Aurobindo Pharma Limited IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-631_1675d27b-d1d8-4024-a140-307046549071 65862-631 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160331 ANDA ANDA203630 Aurobindo Pharma Limited IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-632_fc300330-9d8f-4db9-8159-25fbcc5c0308 65862-632 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20170202 ANDA ANDA203367 Aurobindo Pharma Limited PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-633_fc300330-9d8f-4db9-8159-25fbcc5c0308 65862-633 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20170202 ANDA ANDA203367 Aurobindo Pharma Limited PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-634_fc300330-9d8f-4db9-8159-25fbcc5c0308 65862-634 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20170202 ANDA ANDA203367 Aurobindo Pharma Limited PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-635_fc300330-9d8f-4db9-8159-25fbcc5c0308 65862-635 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20170202 ANDA ANDA203367 Aurobindo Pharma Limited PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 65862-637_eaf2e872-1adf-4dbf-9d12-285a32303e8e 65862-637 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA203081 Aurobindo Pharma Limited IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-638_eaf2e872-1adf-4dbf-9d12-285a32303e8e 65862-638 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA203081 Aurobindo Pharma Limited IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-639_eaf2e872-1adf-4dbf-9d12-285a32303e8e 65862-639 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20120927 ANDA ANDA203081 Aurobindo Pharma Limited IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-648_f4998be2-0a20-4cc1-a35c-0ca39af19d31 65862-648 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20160325 ANDA ANDA204572 Aurobindo Pharma Limited RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65862-649_f4998be2-0a20-4cc1-a35c-0ca39af19d31 65862-649 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20160325 ANDA ANDA204572 Aurobindo Pharma Limited RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65862-650_f4998be2-0a20-4cc1-a35c-0ca39af19d31 65862-650 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20160325 ANDA ANDA204572 Aurobindo Pharma Limited RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65862-651_f4998be2-0a20-4cc1-a35c-0ca39af19d31 65862-651 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20160325 ANDA ANDA204572 Aurobindo Pharma Limited RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65862-652_83d0afc3-6b05-4d40-8824-9bad2cd2e20b 65862-652 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20151013 ANDA ANDA203175 Aurobindo Pharma Limited MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 65862-653_83d0afc3-6b05-4d40-8824-9bad2cd2e20b 65862-653 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20151013 ANDA ANDA203175 Aurobindo Pharma Limited MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 65862-654_10e22f9f-9666-447e-a3fb-611609169a0c 65862-654 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20150619 ANDA ANDA203437 Aurobindo Pharma Limited ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 65862-656_0384b4e8-01bd-49c4-a245-cfe15a1dd736 65862-656 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140515 ANDA ANDA203708 Aurobindo Pharma Limited OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-657_0384b4e8-01bd-49c4-a245-cfe15a1dd736 65862-657 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140515 ANDA ANDA203708 Aurobindo Pharma Limited OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-658_0384b4e8-01bd-49c4-a245-cfe15a1dd736 65862-658 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140515 ANDA ANDA203708 Aurobindo Pharma Limited OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-659_0384b4e8-01bd-49c4-a245-cfe15a1dd736 65862-659 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140515 ANDA ANDA203708 Aurobindo Pharma Limited OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-661_d24d0b1b-68ec-4727-a10e-19741f96aa04 65862-661 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151008 ANDA ANDA203908 Aurobindo Pharma Limited ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-662_d24d0b1b-68ec-4727-a10e-19741f96aa04 65862-662 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151008 ANDA ANDA203908 Aurobindo Pharma Limited ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-663_d24d0b1b-68ec-4727-a10e-19741f96aa04 65862-663 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151008 ANDA ANDA203908 Aurobindo Pharma Limited ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-664_d24d0b1b-68ec-4727-a10e-19741f96aa04 65862-664 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151008 ANDA ANDA203908 Aurobindo Pharma Limited ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-665_d24d0b1b-68ec-4727-a10e-19741f96aa04 65862-665 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151008 ANDA ANDA203908 Aurobindo Pharma Limited ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-666_d24d0b1b-68ec-4727-a10e-19741f96aa04 65862-666 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20151008 ANDA ANDA203908 Aurobindo Pharma Limited ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20191231 65862-667_0008d3d4-8170-47f1-a629-bf8c68438060 65862-667 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20140331 ANDA ANDA203494 Aurobindo Pharma Limited TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 65862-670_01c4124a-83a0-4403-b4e5-675a09804fd3 65862-670 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA203820 Aurobindo Pharma Limited REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20191231 65862-671_01c4124a-83a0-4403-b4e5-675a09804fd3 65862-671 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA203820 Aurobindo Pharma Limited REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20191231 65862-672_01c4124a-83a0-4403-b4e5-675a09804fd3 65862-672 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20140122 ANDA ANDA203820 Aurobindo Pharma Limited REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20191231 65862-673_dd39c559-5c5d-4d3b-9228-c44085e1699f 65862-673 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130117 ANDA ANDA203417 Aurobindo Pharma Limited FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65862-674_dd39c559-5c5d-4d3b-9228-c44085e1699f 65862-674 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130117 ANDA ANDA203417 Aurobindo Pharma Limited FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65862-675_dd39c559-5c5d-4d3b-9228-c44085e1699f 65862-675 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130117 ANDA ANDA203417 Aurobindo Pharma Limited FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65862-676_b4d117e5-3a6f-4856-be50-a6d178924efb 65862-676 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20150731 ANDA ANDA203346 Aurobindo Pharma Limited ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65862-677_b4d117e5-3a6f-4856-be50-a6d178924efb 65862-677 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20150731 ANDA ANDA203346 Aurobindo Pharma Limited ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65862-678_b4d117e5-3a6f-4856-be50-a6d178924efb 65862-678 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20150731 ANDA ANDA203346 Aurobindo Pharma Limited ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65862-679_b4d117e5-3a6f-4856-be50-a6d178924efb 65862-679 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20150731 ANDA ANDA203346 Aurobindo Pharma Limited ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 65862-683_31c7b351-7360-4459-a171-c90debf2e183 65862-683 HUMAN PRESCRIPTION DRUG Tramadol hydrochloride Tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20151020 ANDA ANDA204421 Aurobindo Pharma Limited TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 65862-684_16509c6f-ff5c-4a20-b94a-c5474a13275a 65862-684 HUMAN PRESCRIPTION DRUG Indomethacin Extended-Release Indomethacin Extended-Release CAPSULE ORAL 20161227 ANDA ANDA204243 Aurobindo Pharma Limited INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65862-688_6088ebb5-dfe3-4fe2-9bff-9d9392301599 65862-688 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20151118 ANDA ANDA203963 Aurobindo Pharma Limited SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 65862-692_60f3368b-e6ea-4c6f-a1b0-b0858c07f24a 65862-692 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20150610 ANDA ANDA204309 Aurobindo Pharma Limited PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 65862-693_478f84fb-118e-4576-9989-94ad53fce9ca 65862-693 HUMAN PRESCRIPTION DRUG carisoprodol carisoprodol TABLET ORAL 20161108 ANDA ANDA040792 Aurobindo Pharma Limited CARISOPRODOL 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 65862-694_3c7d8e02-a6dd-4ad2-9151-577459172398 65862-694 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150529 ANDA ANDA203974 Aurobindo Pharma Limited METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 65862-695_3c7d8e02-a6dd-4ad2-9151-577459172398 65862-695 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150529 ANDA ANDA203974 Aurobindo Pharma Limited METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 65862-697_bcfb15c1-e861-485c-9555-4d52ac59d4cb 65862-697 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111123 ANDA ANDA200834 Aurobindo Pharma Limited VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 65862-698_d772d54c-9ecf-4902-86df-7faa58b07973 65862-698 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 Aurobindo Pharma Limited CEFUROXIME AXETIL 125 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-699_d772d54c-9ecf-4902-86df-7faa58b07973 65862-699 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 Aurobindo Pharma Limited CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-700_d772d54c-9ecf-4902-86df-7faa58b07973 65862-700 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 Aurobindo Pharma Limited CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-702_f6cf763a-23cd-43c2-b054-c9c91d23ba8d 65862-702 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20161227 ANDA ANDA204117 Aurobindo Pharma Limited ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-703_f6cf763a-23cd-43c2-b054-c9c91d23ba8d 65862-703 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20161227 ANDA ANDA204117 Aurobindo Pharma Limited ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-704_f6cf763a-23cd-43c2-b054-c9c91d23ba8d 65862-704 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20161227 ANDA ANDA204117 Aurobindo Pharma Limited ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-705_f6cf763a-23cd-43c2-b054-c9c91d23ba8d 65862-705 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20161227 ANDA ANDA204117 Aurobindo Pharma Limited ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-706_c06b8ac9-4f1e-491a-85a6-41e3c62f5513 65862-706 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20140915 ANDA ANDA204030 Aurobindo Pharma Limited AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 65862-707_c06b8ac9-4f1e-491a-85a6-41e3c62f5513 65862-707 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20140915 ANDA ANDA204030 Aurobindo Pharma Limited AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 65862-709_87ca789b-02f8-402a-80fb-34bd4f5bd6eb 65862-709 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20150828 ANDA ANDA204310 Aurobindo Pharma Limited RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 65862-715_4253fcb8-1ba7-4d49-817b-259650f883f9 65862-715 HUMAN PRESCRIPTION DRUG Norethindrone acetate Norethindrone acetate TABLET ORAL 20160108 ANDA ANDA204236 Aurobindo Pharma Limited NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 65862-721_d11c3211-b4d4-4893-8c1c-b8fb6d0a0b89 65862-721 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20170217 ANDA ANDA205761 Aurobindo Pharma Limited RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 65862-732_1243af30-1a5d-46d4-a1b2-2158a287c6a6 65862-732 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20160603 ANDA ANDA204742 Aurobindo Pharma Limited AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 65862-733_31c7b351-7360-4459-a171-c90debf2e183 65862-733 HUMAN PRESCRIPTION DRUG Tramadol hydrochloride Tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20151020 ANDA ANDA204421 Aurobindo Pharma Limited TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 65862-734_31c7b351-7360-4459-a171-c90debf2e183 65862-734 HUMAN PRESCRIPTION DRUG Tramadol hydrochloride Tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20151020 ANDA ANDA204421 Aurobindo Pharma Limited TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 65862-737_7fa25f10-29e0-4162-81a8-9d2e03054ded 65862-737 HUMAN PRESCRIPTION DRUG Amlodipine and valsartan Amlodipine and valsartan TABLET, FILM COATED ORAL 20160422 ANDA ANDA206512 Aurobindo Pharma Limited AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-738_7fa25f10-29e0-4162-81a8-9d2e03054ded 65862-738 HUMAN PRESCRIPTION DRUG Amlodipine and valsartan Amlodipine and valsartan TABLET, FILM COATED ORAL 20160422 ANDA ANDA206512 Aurobindo Pharma Limited AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-739_7fa25f10-29e0-4162-81a8-9d2e03054ded 65862-739 HUMAN PRESCRIPTION DRUG Amlodipine and valsartan Amlodipine and valsartan TABLET, FILM COATED ORAL 20160422 ANDA ANDA206512 Aurobindo Pharma Limited AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-740_7fa25f10-29e0-4162-81a8-9d2e03054ded 65862-740 HUMAN PRESCRIPTION DRUG Amlodipine and valsartan Amlodipine and valsartan TABLET, FILM COATED ORAL 20160422 ANDA ANDA206512 Aurobindo Pharma Limited AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-741_8c94d403-809b-43b9-834f-3ecd330d2dd9 65862-741 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA204798 Aurobindo Pharma Limited OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-742_8c94d403-809b-43b9-834f-3ecd330d2dd9 65862-742 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA204798 Aurobindo Pharma Limited OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-743_8c94d403-809b-43b9-834f-3ecd330d2dd9 65862-743 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA204798 Aurobindo Pharma Limited OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-744_6396974f-cfc6-477f-a475-53370eab1eeb 65862-744 HUMAN PRESCRIPTION DRUG Galantamine Galantamine CAPSULE, EXTENDED RELEASE ORAL 20160805 ANDA ANDA204895 Aurobindo Pharma Limited GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65862-745_6396974f-cfc6-477f-a475-53370eab1eeb 65862-745 HUMAN PRESCRIPTION DRUG Galantamine Galantamine CAPSULE, EXTENDED RELEASE ORAL 20160805 ANDA ANDA204895 Aurobindo Pharma Limited GALANTAMINE HYDROBROMIDE 16 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65862-746_6396974f-cfc6-477f-a475-53370eab1eeb 65862-746 HUMAN PRESCRIPTION DRUG Galantamine Galantamine CAPSULE, EXTENDED RELEASE ORAL 20160805 ANDA ANDA204895 Aurobindo Pharma Limited GALANTAMINE HYDROBROMIDE 24 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 65862-751_7a21e8b4-2c54-4cee-830a-4399bce60db8 65862-751 HUMAN PRESCRIPTION DRUG Cefixime cefixime POWDER, FOR SUSPENSION ORAL 20150414 ANDA ANDA204835 Aurobindo Pharma Limited CEFIXIME 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-752_7a21e8b4-2c54-4cee-830a-4399bce60db8 65862-752 HUMAN PRESCRIPTION DRUG Cefixime cefixime POWDER, FOR SUSPENSION ORAL 20150414 ANDA ANDA204835 Aurobindo Pharma Limited CEFIXIME 200 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 65862-753_8840b589-bd79-4877-b1cf-4a5e31c86a9f 65862-753 HUMAN PRESCRIPTION DRUG VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE TABLET ORAL 20160331 ANDA ANDA204750 Aurobindo Pharma Limited VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 65862-757_95ece6ad-1aba-4c61-9459-b00b9861d3d4 65862-757 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride Olopatadine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20151218 ANDA ANDA204812 Aurobindo Pharma Limited OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 65862-768_84fcea7a-05ed-44c2-98fa-7e87b28d2261 65862-768 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, COATED ORAL 20160505 ANDA ANDA205118 Aurobindo Pharma Limited FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 65862-769_84fcea7a-05ed-44c2-98fa-7e87b28d2261 65862-769 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, COATED ORAL 20160505 ANDA ANDA205118 Aurobindo Pharma Limited FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 65862-776_2f83d137-a7fb-4ea8-ae48-08ba6272462f 65862-776 HUMAN PRESCRIPTION DRUG Mili norgestimate and ethinyl estradiol KIT 20160707 ANDA ANDA205449 Aurobindo Pharma Limited N 20181231 65862-777_e2c5579f-0faf-44d2-8430-5229321d6890 65862-777 HUMAN PRESCRIPTION DRUG Tri-Mili Norgestimate and Ethinyl Estradiol KIT 20160706 ANDA ANDA205441 Aurobindo Pharma Limited N 20191231 65862-778_72089a5d-3dfa-41fb-b560-adc5721bfbc6 65862-778 HUMAN PRESCRIPTION DRUG Tri-Lo-Mili Norgestimate and Ethinyl Estradiol KIT 20161104 ANDA ANDA205762 Aurobindo Pharma Limited N 20181231 65862-779_744c1785-42b2-46a5-b0f4-2887a9ec2051 65862-779 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170424 ANDA ANDA205391 Aurobindo Pharma Limited OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-780_744c1785-42b2-46a5-b0f4-2887a9ec2051 65862-780 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170424 ANDA ANDA205391 Aurobindo Pharma Limited OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-781_744c1785-42b2-46a5-b0f4-2887a9ec2051 65862-781 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide Olmesartan Medoxomil and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170424 ANDA ANDA205391 Aurobindo Pharma Limited OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-782_26ca674e-a47d-4294-8ab8-3b1e7bae1cc4 65862-782 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20160705 ANDA ANDA205661 Aurobindo Pharma Limited METHENAMINE HIPPURATE 1 g/1 N 20191231 65862-783_9bb087b8-de74-4533-8fdb-318b466c3ef6 65862-783 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20160421 ANDA ANDA205606 Aurobindo Pharma Limited ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65862-784_9bb087b8-de74-4533-8fdb-318b466c3ef6 65862-784 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20160421 ANDA ANDA205606 Aurobindo Pharma Limited ESOMEPRAZOLE MAGNESIUM DIHYDRATE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 65862-818_dd6e612f-39e2-4222-a0c7-d21faea18890 65862-818 HUMAN PRESCRIPTION DRUG Tenofovir Disoproxil Fumarate Tenofovir Disoproxil Fumarate TABLET, FILM COATED ORAL 20180126 ANDA ANDA090647 Aurobindo Pharma Limited TENOFOVIR DISOPROXIL FUMARATE 150 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 65862-819_dd6e612f-39e2-4222-a0c7-d21faea18890 65862-819 HUMAN PRESCRIPTION DRUG Tenofovir Disoproxil Fumarate Tenofovir Disoproxil Fumarate TABLET, FILM COATED ORAL 20180126 ANDA ANDA090647 Aurobindo Pharma Limited TENOFOVIR DISOPROXIL FUMARATE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 65862-820_dd6e612f-39e2-4222-a0c7-d21faea18890 65862-820 HUMAN PRESCRIPTION DRUG Tenofovir Disoproxil Fumarate Tenofovir Disoproxil Fumarate TABLET, FILM COATED ORAL 20180126 ANDA ANDA090647 Aurobindo Pharma Limited TENOFOVIR DISOPROXIL FUMARATE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 65862-829_596c923d-db8d-4b96-bf31-52186a38c30d 65862-829 HUMAN PRESCRIPTION DRUG Prasugrel Prasugrel TABLET, FILM COATED ORAL 20171016 ANDA ANDA205888 Aurobindo Pharma Limited PRASUGREL HYDROCHLORIDE 5 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 65862-830_596c923d-db8d-4b96-bf31-52186a38c30d 65862-830 HUMAN PRESCRIPTION DRUG Prasugrel Prasugrel TABLET, FILM COATED ORAL 20171016 ANDA ANDA205888 Aurobindo Pharma Limited PRASUGREL HYDROCHLORIDE 10 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 65862-834_6fba5243-ee00-4825-a04a-321cb6b49c56 65862-834 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20171219 ANDA ANDA206180 Aurobindo Pharma Limited AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-835_6fba5243-ee00-4825-a04a-321cb6b49c56 65862-835 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20171219 ANDA ANDA206180 Aurobindo Pharma Limited AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-836_6fba5243-ee00-4825-a04a-321cb6b49c56 65862-836 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20171219 ANDA ANDA206180 Aurobindo Pharma Limited AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-837_6fba5243-ee00-4825-a04a-321cb6b49c56 65862-837 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20171219 ANDA ANDA206180 Aurobindo Pharma Limited AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-838_6fba5243-ee00-4825-a04a-321cb6b49c56 65862-838 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20171219 ANDA ANDA206180 Aurobindo Pharma Limited AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 320; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-840_8877013d-9b49-40f7-a2c4-99bb519e104e 65862-840 HUMAN PRESCRIPTION DRUG MOXIFLOXACIN MOXIFLOXACIN SOLUTION/ DROPS OPHTHALMIC 20171004 ANDA ANDA206242 Aurobindo Pharma Limited MOXIFLOXACIN HYDROCHLORIDE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 65862-841_4c4c3022-1a1c-49d6-99a8-3f0ad83c9bf6 65862-841 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET ORAL 20150826 ANDA ANDA206217 Aurobindo Pharma Limited ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-842_4c4c3022-1a1c-49d6-99a8-3f0ad83c9bf6 65862-842 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET ORAL 20150826 ANDA ANDA206217 Aurobindo Pharma Limited ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-844_8feeb709-49f3-4c85-9a2c-d78d98c0198f 65862-844 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20161129 ANDA ANDA206433 Aurobindo Pharma Limited CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-845_8feeb709-49f3-4c85-9a2c-d78d98c0198f 65862-845 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20161129 ANDA ANDA206433 Aurobindo Pharma Limited CLOZAPINE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-846_8feeb709-49f3-4c85-9a2c-d78d98c0198f 65862-846 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20161129 ANDA ANDA206433 Aurobindo Pharma Limited CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-847_8feeb709-49f3-4c85-9a2c-d78d98c0198f 65862-847 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20161129 ANDA ANDA206433 Aurobindo Pharma Limited CLOZAPINE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-848_f024bc8e-6245-47e2-9842-7b88b1053ea5 65862-848 HUMAN PRESCRIPTION DRUG Ayuna Levonorgestrel and Ethinyl Estradiol KIT 20160923 ANDA ANDA206866 Aurobindo Pharma Limited N 20181231 65862-849_ba575762-2651-42d5-9668-9ebe7f6a172f 65862-849 HUMAN PRESCRIPTION DRUG Afirmelle Levonorgestrel and Ethinyl Estradiol KIT 20161114 ANDA ANDA206886 Aurobindo Pharma Limited N 20181231 65862-854_b13a8b46-104e-4b75-8f4a-928d2204eff5 65862-854 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170515 ANDA ANDA206906 Aurobindo Pharma Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 65862-855_b13a8b46-104e-4b75-8f4a-928d2204eff5 65862-855 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170515 ANDA ANDA206906 Aurobindo Pharma Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-856_b13a8b46-104e-4b75-8f4a-928d2204eff5 65862-856 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170515 ANDA ANDA206906 Aurobindo Pharma Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-857_b13a8b46-104e-4b75-8f4a-928d2204eff5 65862-857 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170515 ANDA ANDA206906 Aurobindo Pharma Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-858_eafa5b05-d692-48e7-a413-30f847547eb2 65862-858 HUMAN PRESCRIPTION DRUG ALBUTEROL SULFATE ALBUTEROL SULFATE SOLUTION RESPIRATORY (INHALATION) 20171017 ANDA ANDA206224 Aurobindo Pharma Limited ALBUTEROL SULFATE .83 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 65862-859_b236d8cc-5e95-4d47-8b70-4ca928dbb014 65862-859 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20151222 ANDA ANDA206530 Aurobindo Pharma Limited FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 65862-860_b236d8cc-5e95-4d47-8b70-4ca928dbb014 65862-860 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20151222 ANDA ANDA206530 Aurobindo Pharma Limited FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 65862-861_28ed5b58-46dd-4140-a877-4b422f780a94 65862-861 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160919 ANDA ANDA206743 Aurobindo Pharma Limited DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 65862-862_28ed5b58-46dd-4140-a877-4b422f780a94 65862-862 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160919 ANDA ANDA206743 Aurobindo Pharma Limited DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 65862-864_a57029ee-8fa2-4ecc-84b2-9c9a3954529e 65862-864 HUMAN PRESCRIPTION DRUG Simpesse Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol KIT 20170407 ANDA ANDA206851 Aurobindo Pharma Limited N 20181231 65862-866_a14bbbb9-d714-4245-b690-44f9d7c905f3 65862-866 HUMAN PRESCRIPTION DRUG Lo Simpesse Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol KIT 20170428 ANDA ANDA206852 Aurobindo Pharma Limited N 20181231 65862-867_a106081f-9011-465a-b236-0c427cfadb24 65862-867 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20150903 ANDA ANDA206511 Aurobindo Pharma Limited TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-868_a106081f-9011-465a-b236-0c427cfadb24 65862-868 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20150903 ANDA ANDA206511 Aurobindo Pharma Limited TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-869_a106081f-9011-465a-b236-0c427cfadb24 65862-869 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20150903 ANDA ANDA206511 Aurobindo Pharma Limited TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 65862-870_a42a35e6-3e08-4b4f-ae56-47d4aec2322a 65862-870 HUMAN PRESCRIPTION DRUG Risedronate Sodium Risedronate Sodium TABLET, FILM COATED ORAL 20161021 ANDA ANDA206768 Aurobindo Pharma Limited RISEDRONATE SODIUM 150 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 65862-873_6562eb60-0d70-4909-bd07-88d5c9241516 65862-873 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA207655 Aurobindo Pharma Limited QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-874_6562eb60-0d70-4909-bd07-88d5c9241516 65862-874 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA207655 Aurobindo Pharma Limited QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-875_6562eb60-0d70-4909-bd07-88d5c9241516 65862-875 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA207655 Aurobindo Pharma Limited QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-876_6562eb60-0d70-4909-bd07-88d5c9241516 65862-876 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA207655 Aurobindo Pharma Limited QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-877_6562eb60-0d70-4909-bd07-88d5c9241516 65862-877 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA207655 Aurobindo Pharma Limited QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 65862-886_c14d332a-db82-49b3-a035-4dd090d932ef 65862-886 HUMAN PRESCRIPTION DRUG SIMLIYA Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol KIT 20170322 ANDA ANDA206853 Aurobindo Pharma Limited N 20181231 65862-887_7d566e6b-24ad-45d9-a7dc-67f7470a5237 65862-887 HUMAN PRESCRIPTION DRUG Kalliga Desogestrel and Ethinyl Estradiol KIT 20170517 ANDA ANDA207081 Aurobindo Pharma Limited N 20181231 65862-888_8f4ce343-c766-4ea6-ac62-d07ec6dc6f3a 65862-888 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, EXTENDED RELEASE ORAL 20170512 ANDA ANDA206928 Aurobindo Pharma Limited GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65862-889_8f4ce343-c766-4ea6-ac62-d07ec6dc6f3a 65862-889 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, EXTENDED RELEASE ORAL 20170512 ANDA ANDA206928 Aurobindo Pharma Limited GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65862-890_8f4ce343-c766-4ea6-ac62-d07ec6dc6f3a 65862-890 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, EXTENDED RELEASE ORAL 20170512 ANDA ANDA206928 Aurobindo Pharma Limited GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 65862-891_a5738c7c-2754-43e1-b988-db167fb316a9 65862-891 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20160122 ANDA ANDA206837 Aurobindo Pharma Limited VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 65862-892_a5738c7c-2754-43e1-b988-db167fb316a9 65862-892 HUMAN PRESCRIPTION DRUG Voriconazole Voriconazole TABLET, FILM COATED ORAL 20160122 ANDA ANDA206837 Aurobindo Pharma Limited VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 65862-897_4cddb848-d4a4-4271-920d-36aaae8b787b 65862-897 HUMAN PRESCRIPTION DRUG Nylia 7/7/7 Norethindrone and Ethinyl Estradiol KIT 20161021 ANDA ANDA207054 Aurobindo Pharma Limited N 20181231 65862-898_216b3886-5326-4846-9705-9cdf9ce82da0 65862-898 HUMAN PRESCRIPTION DRUG Nylia 1/35 Norethindrone and Ethinyl Estradiol KIT 20161021 ANDA ANDA207056 Aurobindo Pharma Limited N 20181231 65862-899_bbde10a2-1602-4bc9-94d7-e92fd9dbee79 65862-899 HUMAN PRESCRIPTION DRUG Cyonanz Norethindrone and Ethinyl Estradiol KIT 20161021 ANDA ANDA207055 Aurobindo Pharma Limited N 20181231 65862-900_ec812f01-1b9b-43e6-a92e-e604fb7872dc 65862-900 HUMAN PRESCRIPTION DRUG Abacavir and Lamivudine Abacavir and Lamivudine TABLET, FILM COATED ORAL 20170328 ANDA ANDA206151 Aurobindo Pharma Limited ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 65862-905_ff2b6bda-4acd-41fd-8970-458c5265df21 65862-905 HUMAN PRESCRIPTION DRUG Ipratropium bromide Ipratropium bromide SOLUTION RESPIRATORY (INHALATION) 20161027 ANDA ANDA206543 Aurobindo Pharma Limited IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 65862-907_6ce94f2d-2936-4b37-9a57-e40be932ba8b 65862-907 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20160201 ANDA ANDA206827 Aurobindo Pharma Limited CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65862-908_6ce94f2d-2936-4b37-9a57-e40be932ba8b 65862-908 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20160201 ANDA ANDA206827 Aurobindo Pharma Limited CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65862-909_6ce94f2d-2936-4b37-9a57-e40be932ba8b 65862-909 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20160201 ANDA ANDA206827 Aurobindo Pharma Limited CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65862-910_6ce94f2d-2936-4b37-9a57-e40be932ba8b 65862-910 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20160201 ANDA ANDA206827 Aurobindo Pharma Limited CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 65862-914_9212b076-b1ae-4c06-bd56-0ae3c5c9acdf 65862-914 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20160511 ANDA ANDA207021 Aurobindo Pharma Limited ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65862-915_9212b076-b1ae-4c06-bd56-0ae3c5c9acdf 65862-915 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20160511 ANDA ANDA207021 Aurobindo Pharma Limited ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 65862-921_ab0cd45f-0c4b-4ce7-bf8e-5f98d43feaab 65862-921 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate Sevelamer Carbonate TABLET, FILM COATED ORAL 20170717 ANDA ANDA207179 Aurobindo Pharma Limited SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 65862-922_fbb4c7d0-50fa-49c8-b29e-8bef398e7652 65862-922 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20170322 ANDA ANDA207152 Aurobindo Pharma Limited TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 65862-925_0b87cef0-610c-469d-92ba-4007f4bc3878 65862-925 HUMAN PRESCRIPTION DRUG Incassia NORETHINDRONE TABLET ORAL 20160923 ANDA ANDA207304 Aurobindo Pharma Limited NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 65862-926_0ff53815-ccf8-4271-8f5b-7dab45edd0d6 65862-926 HUMAN PRESCRIPTION DRUG Nexesta Fe norethindrone and ethinyl estradiol and ferrous fumarate KIT 20170202 ANDA ANDA207535 Aurobindo Pharma Limited N 20181231 65862-927_a283ab76-0afd-4a83-91e5-c4a0d69b20e7 65862-927 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20140920 ANDA ANDA203687 Aurobindo Pharma Limited FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 65862-930_ea201bff-cdfb-4304-bdb1-d05c1dac2677 65862-930 HUMAN PRESCRIPTION DRUG SEVELAMER CARBONATE SEVELAMER CARBONATE POWDER, FOR SUSPENSION ORAL 20170613 ANDA ANDA207624 Aurobindo Pharma Limited SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 65862-931_ea201bff-cdfb-4304-bdb1-d05c1dac2677 65862-931 HUMAN PRESCRIPTION DRUG SEVELAMER CARBONATE SEVELAMER CARBONATE POWDER, FOR SUSPENSION ORAL 20170613 ANDA ANDA207624 Aurobindo Pharma Limited SEVELAMER CARBONATE 2400 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 65862-932_db5fd05d-7eb9-4291-8f74-a9c428afe2f4 65862-932 HUMAN PRESCRIPTION DRUG NEVIRAPINE NEVIRAPINE TABLET, EXTENDED RELEASE ORAL 20161123 ANDA ANDA208616 Aurobindo Pharma Limited NEVIRAPINE 100 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 65862-933_8a6afd31-b9b4-4e76-8a0f-dd3687afb1a0 65862-933 HUMAN PRESCRIPTION DRUG NEVIRAPINE NEVIRAPINE TABLET, EXTENDED RELEASE ORAL 20170228 ANDA ANDA207698 Aurobindo Pharma Limited NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 65862-934_a74f30b0-912b-4f78-9d6c-370e818444fc 65862-934 HUMAN PRESCRIPTION DRUG Aurovela 24 Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20170615 ANDA ANDA207504 Aurobindo Pharma Limited N 20181231 65862-935_72f731f3-9fb4-469a-9a9e-36ba03249877 65862-935 HUMAN PRESCRIPTION DRUG Aurovela 1.5/30 Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20170626 ANDA ANDA207581 Aurobindo Pharma Limited NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1.5; 30 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 65862-936_f560c8b7-870c-4ed2-801e-2566671c461c 65862-936 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20160114 ANDA ANDA207672 Aurobindo Pharma Limited PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 65862-937_f560c8b7-870c-4ed2-801e-2566671c461c 65862-937 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20160114 ANDA ANDA207672 Aurobindo Pharma Limited PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 65862-938_f560c8b7-870c-4ed2-801e-2566671c461c 65862-938 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20160114 ANDA ANDA207672 Aurobindo Pharma Limited PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 65862-939_05bb77c3-33ec-4315-810d-8a943842e1ce 65862-939 HUMAN PRESCRIPTION DRUG Aurovela 1/20 Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20170616 ANDA ANDA207506 Aurobindo Pharma Limited NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; 20 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 65862-940_eec6d803-fc56-4dba-af1a-992aade4b7d2 65862-940 HUMAN PRESCRIPTION DRUG Aurovela Fe 1/20 Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20170616 ANDA ANDA207505 Aurobindo Pharma Limited N 20181231 65862-941_70b83181-4e7c-4b01-82d2-ffa01f91871d 65862-941 HUMAN PRESCRIPTION DRUG AUROVELA Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20170615 ANDA ANDA207580 Aurobindo Pharma Limited N 20181231 65862-942_e1a9effb-6ef7-4651-b0ef-a9265600caff 65862-942 HUMAN PRESCRIPTION DRUG LEVALBUTEROL LEVALBUTEROL SOLUTION, CONCENTRATE RESPIRATORY (INHALATION) 20170131 ANDA ANDA207628 Aurobindo Pharma Limited LEVALBUTEROL HYDROCHLORIDE 1.25 mg/.5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 65862-943_44de1381-6448-4268-a456-24fbb4584f04 65862-943 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION RESPIRATORY (INHALATION) 20161230 ANDA ANDA207625 Aurobindo Pharma Limited LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 65862-944_44de1381-6448-4268-a456-24fbb4584f04 65862-944 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION RESPIRATORY (INHALATION) 20161230 ANDA ANDA207625 Aurobindo Pharma Limited LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 65862-945_44de1381-6448-4268-a456-24fbb4584f04 65862-945 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION RESPIRATORY (INHALATION) 20161230 ANDA ANDA207625 Aurobindo Pharma Limited LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 65862-959_74c2e1d3-3ed8-4c43-9983-d8326b3111ee 65862-959 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141024 ANDA ANDA090554 Aurobindo Pharma Limited DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 65862-967_f18cc76f-82aa-4ad7-b8ce-5737733ee104 65862-967 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20160915 ANDA ANDA208451 Aurobindo Pharma Limited ESZOPICLONE 1 mg/1 CIV N 20181231 65862-968_f18cc76f-82aa-4ad7-b8ce-5737733ee104 65862-968 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20160915 ANDA ANDA208451 Aurobindo Pharma Limited ESZOPICLONE 2 mg/1 CIV N 20181231 65862-969_f18cc76f-82aa-4ad7-b8ce-5737733ee104 65862-969 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20160915 ANDA ANDA208451 Aurobindo Pharma Limited ESZOPICLONE 3 mg/1 CIV N 20181231 65862-976_681dfb5c-fc5c-427e-81f6-4b4e934978a2 65862-976 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20161215 ANDA ANDA208727 Aurobindo Pharma Limited TELMISARTAN; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-977_681dfb5c-fc5c-427e-81f6-4b4e934978a2 65862-977 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20161215 ANDA ANDA208727 Aurobindo Pharma Limited TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-978_681dfb5c-fc5c-427e-81f6-4b4e934978a2 65862-978 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20161215 ANDA ANDA208727 Aurobindo Pharma Limited TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 65862-984_5176be07-3121-49fb-9eb9-638903753a31 65862-984 HUMAN PRESCRIPTION DRUG Atracurium Besylate Atracurium Besylate INJECTION, SOLUTION INTRAVENOUS 20150408 ANDA ANDA206010 Aurobindo Pharma Limited ATRACURIUM BESYLATE 50 mg/5mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 65862-985_c3e0a3b9-535d-456b-9a1f-fa18a4d4e38f 65862-985 HUMAN PRESCRIPTION DRUG Atracurium Besylate Atracurium Besylate INJECTION, SOLUTION INTRAVENOUS 20150408 ANDA ANDA206011 Aurobindo Pharma Limited ATRACURIUM BESYLATE 100 mg/10mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 65864-001_273556b3-afbd-4db2-a118-d08198b08d83 65864-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19370101 UNAPPROVED MEDICAL GAS RCS Management Corporation OXYGEN 99 L/100L E 20171231 65868-001_f2c58c37-d398-4521-9437-42f3c7735af1 65868-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Mercy Medical Center- Clinton dba Mercy Home Medical Equipment OXYGEN 99 L/100L E 20171231 65903-171_8b291140-d4a3-4952-a404-1c0b008e3b2b 65903-171 HUMAN OTC DRUG UV Defense Fluid Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 H2O Plus TITANIUM DIOXIDE; ZINC OXIDE 11; 14 g/100mL; g/100mL E 20171231 65903-242_60b452e3-2135-45de-a1fa-18c5141a64d2 65903-242 HUMAN OTC DRUG Anti Acne Exfoliating Cleansing Pads Salicylic Acid SWAB TOPICAL 20080901 OTC MONOGRAPH FINAL part333D H2O Plus SALICYLIC ACID 10 uL/mL E 20171231 65903-247_66d51ead-8eae-43d5-98a8-cde6ab9ac918 65903-247 HUMAN OTC DRUG Anti Acne Clarifying Face Wash Salicylic Acid GEL TOPICAL 20090401 OTC MONOGRAPH FINAL part358B H2O Plus SALICYLIC ACID 15 uL/mL E 20171231 65903-250_85527fb2-ccec-4fbd-b0a7-c44eeeee018f 65903-250 HUMAN OTC DRUG WhiteWater Advanced Brightening WhiteWater Advanced Brightening SPF30 Homosalate,Oxybenzone,Octisalate,Avobenzone LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part352 H2O PLUS AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 8; 4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 65903-270_064707b2-95bb-4409-8bc1-cfd4dad625f0 65903-270 HUMAN OTC DRUG Face Oasis Hydrating Face Oasis Hydrating SPF 30 Avobenzone,Homosalate,Octisalate,Oxybenzone LOTION TOPICAL 20120301 OTC MONOGRAPH FINAL part352 H2O PLUS AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 8; 4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 65903-272_fd1b2bcb-ac4b-4c98-a752-a6e808c1f4a3 65903-272 HUMAN OTC DRUG Anti Acne Calming Corrector Salicylic Acid GEL TOPICAL 20100301 OTC MONOGRAPH FINAL part333D H2O Plus SALICYLIC ACID 15 uL/mL E 20171231 65903-276_5a1f5f5e-7602-4493-a9dc-b7229f61692d 65903-276 HUMAN OTC DRUG Sea Results Line Resolution Sea Results Line Resolution SPF30 Avobenzone,Homosalate,Octisalate,Oxybenzone CREAM TOPICAL 20120301 OTC MONOGRAPH FINAL part352 H2O PLUS AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 8; 4; 5 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 65903-295_c482c8a4-3e32-4950-969c-cc09a455ac2b 65903-295 HUMAN OTC DRUG Sea Pure Hydrating Sea Pure Hydrating SPF20 Titanium Dioxide LOTION TOPICAL 20100610 OTC MONOGRAPH FINAL part352 H2O PLUS TITANIUM DIOXIDE 40 uL/mL E 20171231 65903-330_8d25de87-7bb0-4114-b07e-787f95a29969 65903-330 HUMAN OTC DRUG Green Tea Antioxidant Broad Spectrum SPF 30 PAplusplusplus Oxybenzone, Octisalate, and Avobenzone LOTION TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 H2O Plus LLC OXYBENZONE; OCTISALATE; AVOBENZONE 60; 50; 30 mg/mL; mg/mL; mg/mL E 20171231 65909-089_50e0768b-260a-0b95-8685-1095713008f7 65909-089 HUMAN PRESCRIPTION DRUG STRONTIUM CHLORIDE Sr-89 STRONTIUM CHLORIDE SR-89 INJECTION INTRAVENOUS 20030106 ANDA ANDA075941 BIO NUCLEONICS INC STRONTIUM CHLORIDE SR-89 1 mCi/mL E 20171231 65912-001_9b9d2340-c944-4a5c-8be6-9be1932b695d 65912-001 HUMAN OTC DRUG Pro-Collagen Marine Broad Spectrum SPF 30 AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20180119 OTC MONOGRAPH FINAL part352 ELEMIS Limited AVOBENZONE; OCTINOXATE; OCTOCRYLENE 10; 10; 5 mg/g; mg/g; mg/g N 20181231 65919-001_8c5ed7bf-1367-40dc-9a96-c27d40ab82ea 65919-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20000601 UNAPPROVED MEDICAL GAS Clinical 1 Home Medical, Inc. OXYGEN 99 L/100L E 20171231 65919-002_70939331-bbfc-4d1a-92c9-c997cb1608ab 65919-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20000601 NDA NDA205839 Clinical 1 Home Medical, Inc. NITROGEN 99 L/100L N 20181231 65919-003_60f0fc6f-136b-f8f7-e053-2a91aa0a3a88 65919-003 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000601 NDA NDA205840 Clinical 1 Home Medical, Inc. OXYGEN 100 L/99L N 20181231 65923-001_603e0f64-0970-b731-e053-2a91aa0abf1c 65923-001 HUMAN OTC DRUG Coralite Antibacterial Bandage BENZALKONIUM CHLORIDE SWAB TOPICAL 20140219 OTC MONOGRAPH NOT FINAL part333A UNITED EXCHANGE CORP BENZALKONIUM CHLORIDE .12 mg/100mg N 20181231 65923-003_7cabd213-8446-4e6b-a204-9a6b213d2f01 65923-003 HUMAN OTC DRUG Family Care Hemorrhoidal Mineral oil OINTMENT TOPICAL 20141124 OTC MONOGRAPH FINAL part346 United Exchange Corp MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/100g; mg/100g; mg/100g N 20181231 65923-004_76cd96fa-f9d8-4b01-8a97-f8218e524b8b 65923-004 HUMAN OTC DRUG FAMILY CARE BACITRACIN BACITRACIN OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part333B UNITED EXCHANGE CORP. BACITRACIN 500 [USP'U]/g E 20171231 65923-005_d2cd70ba-6e8c-4cc2-8bfb-0e66dc243306 65923-005 HUMAN OTC DRUG FAMILY CARE CHILDRENS DECONGESTANT NOSE DROPS PHENYLEPHRINE HYDROCHLORIDE SOLUTION NASAL 20120110 OTC MONOGRAPH FINAL part341 UNITED EXCHANGE CORP PHENYLEPHRINE HYDROCHLORIDE 1.25 mg/mL E 20171231 65923-006_f8d2fc24-09e4-4384-9b20-0d392ccf1555 65923-006 HUMAN OTC DRUG FAMILY CARE ACNE TREATMENT BENZOYL PEROXIDE CREAM TOPICAL 20120207 OTC MONOGRAPH FINAL part333D UNITED EXCHANGE CORP. BENZOYL PEROXIDE 10 g/100g N 20181231 65923-007_12fb6064-c3d4-4355-b6b3-0a93dbc5c95a 65923-007 HUMAN OTC DRUG FAMILY CARE TRIPLE ANTIBIOTIC PAIN RELIEF NEOMYCIN SULFATE OINTMENT TOPICAL 20120207 OTC MONOGRAPH FINAL part333B UNITED EXCHANGE CORP. NEOMYCIN SULFATE 3.5 mg/g E 20171231 65923-008_4f4b6d04-acf9-488a-87b7-90453d516be4 65923-008 HUMAN OTC DRUG FAMILY CARE ULTRA STRENGTH PAIN RELIEF CAMPHOR, MENTHOL OINTMENT TOPICAL 20120214 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP. CAMPHOR (SYNTHETIC); MENTHOL 110; 110 mg/g; mg/g E 20171231 65923-009_7c6a5eb5-fe38-4708-ae24-362499edd522 65923-009 HUMAN OTC DRUG FAMILY CARE HEMORRHOIDAL MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL OINTMENT TOPICAL 20120301 OTC MONOGRAPH FINAL part346 UNITED EXCHANGE CORP. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 140; 719; 2.5; 30 mg/g; mg/g; mg/g; mg/g E 20171231 65923-010_42a74cff-db1f-4ce0-a070-0190abab3e87 65923-010 HUMAN OTC DRUG Iodent Maximum Strength Oral Analgesic BENZOCAINE GEL TOPICAL 20130531 OTC MONOGRAPH NOT FINAL part356 United Exchange Corp BENZOCAINE 20 g/100g N 20181231 65923-011_5a41d521-b1b6-43d9-8906-377e559585b2 65923-011 HUMAN OTC DRUG Family Care Nasal Relief OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20130531 OTC MONOGRAPH FINAL part341 United Exchange Corp OXYMETAZOLINE HYDROCHLORIDE 5 g/100mL N 20181231 65923-012_b9b4142f-f721-4e0b-b02b-156a9fdc96a9 65923-012 HUMAN OTC DRUG Family Care Thera Flex Menthol Glycol Salicylate Nonivamide Tocopherol Acetate PATCH TOPICAL 20131115 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL; GLYCOL SALICYLATE; NONIVAMIDE; ALPHA-TOCOPHEROL ACETATE 6.53; 4.66; .01; .93 mg/100mg; mg/100mg; mg/100mg; mg/100mg E 20171231 65923-021_6301ab99-1758-144a-e053-2a91aa0adb77 65923-021 HUMAN OTC DRUG Family Care Antifungal Tolnaftate CREAM TOPICAL 20170102 OTC MONOGRAPH FINAL part333C United Exchange Corp. TOLNAFTATE 10 mg/g N 20191231 65923-046_8144e371-3643-4585-9f01-f39c0753f52c 65923-046 HUMAN OTC DRUG Family Care Triple Antibiotic Neomycin, Bacitracin, Polymyxin B OINTMENT TOPICAL 20140619 OTC MONOGRAPH FINAL part333B United Exchange Corp. BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 65923-051_62eace2c-a374-9ee0-e053-2991aa0a6c50 65923-051 HUMAN OTC DRUG Family Care Antibiotic Neomycin Sulfate OINTMENT TOPICAL 20150101 OTC MONOGRAPH FINAL part333B United Exchange Corp. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20191231 65923-052_63255079-ecf2-1e77-e053-2a91aa0a7b6c 65923-052 HUMAN OTC DRUG Family Care Antifungal Clotrimazole CREAM TOPICAL 20180101 OTC MONOGRAPH FINAL part333C United Exchange Corp. CLOTRIMAZOLE 10 mg/g N 20191231 65923-077_9dc2303f-9008-4a57-b351-e1b533812223 65923-077 HUMAN OTC DRUG SHOPKO ORIGINAL NASAL OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20120301 OTC MONOGRAPH FINAL part341 UNITED EXCHANGE CORP. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL E 20171231 65923-100_9b3d09c8-60c7-41e2-a500-30f72194f73d 65923-100 HUMAN OTC DRUG FAMILY CARE THERA FLEX PAIN CAPSAICIN, CAMPHOR, MENTHOL, METHYL SALICYLATE, PEPPERMINT OIL, ZINC OXIDE PATCH TOPICAL 20120930 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP CAPSAICIN; CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE; PEPPERMINT OIL; ZINC OXIDE .0056; 1.48; 3.95; 3.95; 1.95; 18.77 g/1; g/1; g/1; g/1; g/1; g/1 N 20181231 65923-101_9fb471d5-d147-4a7a-8f57-0690e8249f36 65923-101 HUMAN OTC DRUG Iodent Sensitive Fresh Mint Potassium nitrate and sodium floride PASTE DENTAL 20141023 OTC MONOGRAPH NOT FINAL part356 United Exchange Corp. POTASSIUM NITRATE; SODIUM FLUORIDE 5; .15 mg/100g; mg/100g N 20181231 65923-102_8403ca54-1c8e-477a-9a03-34f2f04da128 65923-102 HUMAN OTC DRUG Iodent Fluoride Regular Fluoride PASTE DENTAL 20141023 OTC MONOGRAPH FINAL part355 United Exchange Corp. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 65923-104_a954f3d9-06b6-48b1-acba-665286b5cf87 65923-104 HUMAN OTC DRUG Family Care Maximum Strength Medicated Anti Itch Menthol CREAM TOPICAL 20141124 OTC MONOGRAPH FINAL part346 United Exchange Corp MENTHOL; PRAMOXINE HYDROCHLORIDE 10; 10 mg/g; mg/g N 20181231 65923-105_d5a39bc5-33ee-4851-a33b-5ddcb523b129 65923-105 HUMAN OTC DRUG Iodent Sensitive Extra Whitening Sodium Fluoride Potassium Nitrate PASTE DENTAL 20141023 OTC MONOGRAPH NOT FINAL part356 United Exchange Corp. SODIUM FLUORIDE; POTASSIUM NITRATE 5; 2.43 mg/g; mg/g N 20181231 65923-106_7b2aa0e9-31de-49cb-995e-92f4da438a86 65923-106 HUMAN OTC DRUG Iodent Animal Kingdom Bubble Gum Sodium Fluoride PASTE DENTAL 20140613 OTC MONOGRAPH FINAL part355 United Exchange Corp. SODIUM FLUORIDE .22 g/100g E 20171231 65923-107_4d218f43-6e05-452a-affc-6cfd6747243b 65923-107 HUMAN OTC DRUG Iodent Animal Kingdom Fruity Fluoride PASTE DENTAL 20140616 OTC MONOGRAPH FINAL part355 United Exchange Corp. SODIUM FLUORIDE .22 g/100g E 20171231 65923-108_a81ad6fb-cba3-4da1-9ab9-ee5e11cdbdbc 65923-108 HUMAN OTC DRUG SoundBody Tolnaftate Antifungal Tolnaftate CREAM TOPICAL 20140226 OTC MONOGRAPH FINAL part333C United Exchange Corp. TOLNAFTATE 10 mg/g N 20181231 65923-111_b36d3097-a761-47fc-ba30-009711e6b76d 65923-111 HUMAN OTC DRUG Acne Shave Cream Salicylic acid CREAM TOPICAL 20170725 OTC MONOGRAPH FINAL part333D United Exchange Corp. SALICYLIC ACID .5 mg/mL N 20181231 65923-120_7903a819-9037-47b8-a04b-c04aa9b64c49 65923-120 HUMAN OTC DRUG Coralite Pain Relief Stick Menthol, and Methyl salicylate STICK TOPICAL 20160210 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL; METHYL SALICYLATE 4; 1 g/100g; g/100g N 20181231 65923-121_62fd8561-2fd0-91d7-e053-2a91aa0a0696 65923-121 HUMAN OTC DRUG Coralite Extra Strength Pain Relief Sleeve Knee Menthol PATCH TOPICAL 20160210 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL 336 mg/1 N 20191231 65923-122_62fd573d-4f55-2a5b-e053-2a91aa0a5685 65923-122 HUMAN OTC DRUG Coralite Extra Strength Pain Relief Sleeve Wrist Menthol PATCH TOPICAL 20160210 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL 336 mg/1 N 20191231 65923-123_bd211fa7-2dd5-4d68-a0dd-85d1fb9626c3 65923-123 HUMAN OTC DRUG Coralite Medicated Heat Capsaicin PATCH TOPICAL 20160210 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. CAPSAICIN 249 mg/1 N 20181231 65923-139_dc665817-8b3c-46fb-a8a5-2145d9e9a93e 65923-139 HUMAN OTC DRUG SoundBody Clotrimazole Antifungal Clotrimazole CREAM TOPICAL 20140226 OTC MONOGRAPH FINAL part333C United Exchange Corp. CLOTRIMAZOLE 10 mg/g N 20181231 65923-145_78a13f1c-4704-4497-a2a7-c60429ab5616 65923-145 HUMAN OTC DRUG Coralite Extra Strength Cool and Hot Menthol PATCH TOPICAL 20141230 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL 50 mg/g N 20181231 65923-150_eb99e540-ab66-491e-a928-202a6f7dc6ec 65923-150 HUMAN OTC DRUG Coralite Pain Relief Menthol PATCH TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL 5 mg/g N 20181231 65923-151_57f26e5f-4a31-4d30-b30d-93a33378d15e 65923-151 HUMAN OTC DRUG Coralite Cold and Hot Menthol PATCH TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL 5 mg/g N 20181231 65923-152_8970c418-20fa-43a0-931a-ee1b519ba254 65923-152 HUMAN OTC DRUG Coralite Pain Relief Menthol Capsaicin PATCH TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL; CAPSAICIN 30; 8.3 mg/g; mg/g N 20181231 65923-153_d140c61b-a2ac-46b7-83e6-cfb4c348089a 65923-153 HUMAN OTC DRUG Coralite Cold and Hot Menthol PATCH TOPICAL 20131216 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL 5 mg/g N 20181231 65923-155_ded24b96-ce7c-4970-a8c7-3804abd09d5b 65923-155 HUMAN OTC DRUG Coralite Muscle Joint Camphor Menthol Menthyl Salicylate PATCH TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE .012; .057; .063 mg/100mg; mg/100mg; mg/100mg N 20181231 65923-156_62ef9b6f-ca70-2605-e053-2a91aa0a0c7b 65923-156 HUMAN OTC DRUG Coralite Pain Relief DL-Camphor, L-Menthol, Methylsalicylate PATCH TOPICAL 20140326 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 1.2; 5.7; 6.3 g/100g; g/100g; g/100g N 20191231 65923-157_08dcfbb6-eabd-4bb0-ab12-5e59150b72c2 65923-157 HUMAN OTC DRUG Coralite Blue Ice Menthol GEL TOPICAL 20161005 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL .02 g/g N 20181231 65923-159_3b530ad0-e490-442a-ac08-c9f690a8c202 65923-159 HUMAN OTC DRUG Coralite Lidocaine Pain Relief Lidocaine PATCH TOPICAL 20170123 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. LIDOCAINE 560 mg/1 N 20181231 65923-161_3af87b7d-8315-4e45-bc41-a0a8bf9b0a16 65923-161 HUMAN OTC DRUG Coralite Muscle and Joint Pain Relief Capsacin LIQUID TOPICAL 20150508 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. CAPSAICIN .0015 g/mL N 20181231 65923-181_6d5057da-087e-4de1-8c07-a046031ab8d1 65923-181 HUMAN OTC DRUG Idodent Flouride Mint Fluoride PASTE DENTAL 20141023 OTC MONOGRAPH FINAL part355 United Exchange Corp. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 65923-249_524ce36b-0a2b-496c-b133-235b81169592 65923-249 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19930804 OTC MONOGRAPH NOT FINAL part343 United Exchange Corporation ASPIRIN 325 mg/1 N 20181231 65923-344_7fd1caa8-0c5d-4be2-9294-f7fbb1e10553 65923-344 HUMAN OTC DRUG UEC Medical Sterile Alcohol Wipes Ispropyl Alcohol CLOTH TOPICAL 20160219 OTC MONOGRAPH NOT FINAL part333A United Exchange Corp. ISOPROPYL ALCOHOL 70 g/100g N 20181231 65923-345_153de797-8167-43f7-a9fc-278be609fe04 65923-345 HUMAN OTC DRUG UEC Medical BZK Antiseptic Wipes Benzalkonium Chloride CLOTH TOPICAL 20160219 OTC MONOGRAPH NOT FINAL part333A United Exchange Corp. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 65923-349_5d25943c-3ec0-48dd-9cc9-441b34101283 65923-349 HUMAN OTC DRUG UEC Medical Insect Sting Relief Isopropyl alcohol, and Benzocaine SWAB TOPICAL 20160425 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. BENZOCAINE; ISOPROPYL ALCOHOL .06; .7 mg/1; mg/1 N 20181231 65923-385_81fdbf83-21e6-4e28-b688-a17f686a69be 65923-385 HUMAN OTC DRUG Family Care Pain Relief DL-Camphor, L-Menthol, Methylsalicylate PATCH TOPICAL 20131126 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 1.2; 5.7; 6.3 g/100g; g/100g; g/100g E 20171231 65923-387_d18f82b5-67b5-4264-a214-366aa128e51b 65923-387 HUMAN OTC DRUG Assured Nasal Relief Oxymetazoline Hydrochloride SPRAY NASAL 20131120 OTC MONOGRAPH FINAL part341 United Exchange Corp. OXYMETAZOLINE HYDROCHLORIDE .05 mg/100mL N 20181231 65923-472_55bd55b0-625c-4451-935a-13b6f9c1f498 65923-472 HUMAN OTC DRUG FAMILY CARE HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP. HYDROCORTISONE 1 g/100g E 20171231 65923-492_18f3072a-07e0-4907-8825-6ff335775933 65923-492 HUMAN OTC DRUG Family Care Hydrocortisone Hydrocortisone OINTMENT TOPICAL 20141124 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. HYDROCORTISONE 1 g/100g N 20181231 65923-495_bf06744c-d19e-49be-a34d-1c787367b51b 65923-495 HUMAN OTC DRUG Family Care Anti-Itch Diphenhydramine hydrochloride Zinc Acetate CREAM TOPICAL 20141124 OTC MONOGRAPH FINAL part347 United Exchange Corp. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1; .1 g/100g; g/100g N 20181231 65923-496_850ba379-d32a-4bec-b718-5f6ecdf12383 65923-496 HUMAN OTC DRUG Family Care Bacitracin Anti-Infection Bacitracin OINTMENT TOPICAL 20141203 OTC MONOGRAPH FINAL part333B United Exchange Corp. BACITRACIN 500 [USP'U]/g N 20181231 65923-498_b3043a3d-89af-4a88-b709-9f08ca2249c1 65923-498 HUMAN OTC DRUG FAMILY CARE MUSCLE RUB PAIN RELIEVER MENTHOL, METHYL SALICYLATE CREAM TOPICAL 20120930 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g N 20181231 65923-502_e9cecc16-0e69-421a-a203-2d4fd9b24ca1 65923-502 HUMAN OTC DRUG Family Care Tolnaftate Tolnaftate CREAM TOPICAL 20130430 OTC MONOGRAPH FINAL part333C United Exchange Corp. TOLNAFTATE 10 mg/g N 20181231 65923-505_c5ee14a7-117e-42c4-8b3b-dd0cceca9500 65923-505 HUMAN OTC DRUG FAMILY CARE CLOTRIMAZOLE ANTIFUNGAL CLOTRIMAZOLE CREAM TOPICAL 20120501 OTC MONOGRAPH FINAL part333C United Exchange Corp. CLOTRIMAZOLE 1 g/100g N 20181231 65923-507_9b6cc2e1-b74f-498b-aa30-81ca986858ff 65923-507 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20160302 OTC MONOGRAPH FINAL part343 United Exchange Corp. ASPIRIN 325 mg/1 N 20181231 65923-510_0c2c05dc-59df-495b-8272-d43721c74a9a 65923-510 HUMAN OTC DRUG Family Care Original Eye TETRAHYDROZOLINE HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 United Exchange Corp TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 65923-511_15b39dc6-c3bb-4c94-8b37-f0f3c2e7fb68 65923-511 HUMAN OTC DRUG Family Care Advanced Formula Eye Tetrahydrozoline hydrochloride, dextran 70, polyethylene glycol 400, povidone SOLUTION/ DROPS OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 United Exchange Corp TETRAHYDROZOLINE HYDROCHLORIDE; DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE .5; 1; 10; 10 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 65923-512_ef591b79-382c-4238-a740-0c7b2efed7b5 65923-512 HUMAN OTC DRUG Family Care Artificial Eye Polyvinyl Alcohol, and Povidones SOLUTION/ DROPS OPHTHALMIC 20160422 OTC MONOGRAPH FINAL part349 United Exchange Corp. POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONES .05; .06 mg/mL; mg/mL N 20181231 65923-514_28ab61f3-d5ce-4bad-9eab-39358158136d 65923-514 HUMAN OTC DRUG FAMILY CARE MUSCLE AND JOINT VANISHING SCENT MENTHOL GEL TOPICAL 20141124 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP. MENTHOL 2.5 g/100g N 20181231 65923-517_61826e8e-6de0-46bb-e053-2a91aa0ac95b 65923-517 HUMAN OTC DRUG Family Care Antibiotic Neomycin Sulfate OINTMENT TOPICAL 20171229 OTC MONOGRAPH FINAL part333B United Exchange Corp. NEOMYCIN SULFATE 3.5 mg/g N 20181231 65923-523_3b3b58be-a652-42f1-ba72-1ac6225c4d2d 65923-523 HUMAN OTC DRUG Family Care Triple Antibiotic Plus Pain Relief Bacitracin Neomycin Sulfate Polymyxin B Sulfate Pramoxine Hydrochloride OINTMENT TOPICAL 20141124 OTC MONOGRAPH FINAL part333B United Exchange Corp. POLYMYXIN B SULFATE; BACITRACIN; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE 10000; 500; 3.5; 10 [USP'U]/g; [USP'U]/g; mg/g; mg/g N 20181231 65923-532_604157f5-f841-4a01-e053-2991aa0a18bf 65923-532 HUMAN OTC DRUG Coralite Ultra Strength Pain Relief Camphor Menthol OINTMENT TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. CAMPHOR (SYNTHETIC); MENTHOL 110; 110 mg/g; mg/g N 20181231 65923-548_638ad65c-4ce1-2aa0-e053-2991aa0a01c4 65923-548 HUMAN OTC DRUG Refresh Optive Single Vial Carboxymethylcellulose Sodium, and Glycerin SOLUTION/ DROPS OPHTHALMIC 20170102 OTC MONOGRAPH FINAL part349 United Exchange Corp. CARBOXYMETHYLCELLULOSE SODIUM; GLYCERIN 5; 9 mg/mL; mg/mL N 20191231 65923-551_7a18e104-1199-4854-80de-955d981a0592 65923-551 HUMAN OTC DRUG Family Care Nasal Relief OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20130630 OTC MONOGRAPH FINAL part341 United Exchange Corp OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 65923-555_68700b97-a9dc-4c75-ae80-b418c2ed1c49 65923-555 HUMAN OTC DRUG FAMILY CARE LUBRICANT SINGLE USE EYE CARBOXYMETHYLCELLULOSE SODIUM SOLUTION/ DROPS OPHTHALMIC 20130228 OTC MONOGRAPH FINAL part349 UNITED EXCHANGE CORP CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 65923-557_709eba12-9d76-41ae-8362-453be1f62c2c 65923-557 HUMAN OTC DRUG Family Care Premium Saline Nasal Sodium chloride SOLUTION NASAL 20140602 OTC MONOGRAPH FINAL part349 United Exchange Corp SODIUM CHLORIDE .29 mg/44mL E 20171231 65923-559_109d51b6-58e3-4dac-bff3-053e305c47c0 65923-559 HUMAN OTC DRUG Sound Body Original Eye Tetrahydrozoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20140519 OTC MONOGRAPH FINAL part349 United Exchange Corp TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/10mg N 20181231 65923-565_256a32b9-d8bb-468f-8822-4862fd60f05c 65923-565 HUMAN OTC DRUG Sound Body Artificial Tears Polyvinyl alcohol, povidone SOLUTION/ DROPS OPHTHALMIC 20140225 OTC MONOGRAPH FINAL part349 United Exchange Corp. POLYVINYL ALCOHOL; POVIDONE 5; 6 mg/mL; mg/mL N 20181231 65923-580_cc4ceea7-3e09-4453-9a63-ca06c909568b 65923-580 HUMAN OTC DRUG Family Care Lubricant Eye Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20170523 OTC MONOGRAPH FINAL part349 United Exchange Corp. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 65923-581_60a5ff34-55dc-5d0a-e053-2a91aa0af105 65923-581 HUMAN OTC DRUG Family Care Preservative Free Single Use Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20160318 OTC MONOGRAPH FINAL part349 United Exchange Corp. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 65923-582_e6b1cde4-654d-4ce9-9a9f-35821f0371ba 65923-582 HUMAN OTC DRUG Family Care Eye Wash Purified Water SOLUTION OPHTHALMIC 20150617 OTC MONOGRAPH FINAL part349 United Exchange Corp. WATER 99.05 mL/100mL E 20171231 65923-583_558e5f09-fbbb-4f0c-b19b-a92fc68487a2 65923-583 HUMAN OTC DRUG Family Care Single-Use Eye Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20160328 OTC MONOGRAPH FINAL part349 United Exchange Corp. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 65923-584_60a69afa-349b-3562-e053-2a91aa0a78d5 65923-584 HUMAN OTC DRUG Family Care Single-Use Eye Polyethylene Glycol 400, and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20160328 OTC MONOGRAPH FINAL part349 United Exchange Corp. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 65923-585_443b8e6e-d766-48f6-bb24-a5a5e1e9853d 65923-585 HUMAN OTC DRUG Family Care Arthritis Pain Relief Capsaicin CREAM TOPICAL 20160726 OTC MONOGRAPH NOT FINAL part348 United Excahnge Corp. CAPSAICIN .75 mg/g N 20181231 65923-587_32733413-0b42-4ba6-b2ed-0e692abe8dce 65923-587 HUMAN OTC DRUG Family Care Ultra Acne Treatment Salicylic Acid GEL TOPICAL 20170217 OTC MONOGRAPH FINAL part333D United Exchange Corp. SALICYLIC ACID 2 g/100g N 20181231 65923-616_fbbed3fc-3353-4c01-aab2-eee8c7d43cc6 65923-616 HUMAN OTC DRUG Sound Body Extra Strength Cold and Hot Menthol, and Methyl Salcylate CREAM TOPICAL 20150224 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL; METHYL SALICYLATE 10; 30 g/100g; g/100g N 20181231 65923-621_a1576fa9-e7f3-4954-af2b-7fecdad3380b 65923-621 HUMAN OTC DRUG Sound Body Extra Strength Cold and Hot Medicated Menthol PATCH TOPICAL 20150225 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. MENTHOL 50 mg/g N 20181231 65923-625_93c6e124-2680-44c9-87eb-3786900c8781 65923-625 HUMAN OTC DRUG Family Care Cough Nighttime Dextromethorphan hydrobromide, and Doxylamine succinate LIQUID ORAL 20150720 OTC MONOGRAPH FINAL part341 United Exchange Corp. DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 65923-626_f4acd1f2-ba98-46c3-80e9-69eaffb79218 65923-626 HUMAN OTC DRUG Family Care Stomach Relief Bismuth subsalicylate LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part335 United Exchange Corp. BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 65923-627_f008c129-7013-4cef-aad3-232bc6b16992 65923-627 HUMAN OTC DRUG Family Care Cold and Flu Multi Symptom Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride LIQUID ORAL 20150723 OTC MONOGRAPH FINAL part341 United Exchange Corp. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 65923-629_d9ec2557-0197-4f78-bca2-7d299bc04a16 65923-629 HUMAN OTC DRUG Family Care Cold and Flu Nighttime Acetaminophen, Dextromethorphan hydrobromide, and Doxylamine succinate LIQUID ORAL 20150721 OTC MONOGRAPH FINAL part341 United Exchange Corp. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 65923-630_a729707a-4add-4db6-aa48-cf71bcc9e2d8 65923-630 HUMAN OTC DRUG Family Care Cold and Flu Multi Symptom Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate LIQUID ORAL 20150730 OTC MONOGRAPH FINAL part341 United Exchange Corp. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 65923-632_afe68de8-2c7f-42aa-b7ac-612902f952d0 65923-632 HUMAN OTC DRUG Family Care Multi Symptom Cold Dextromethorphan hydrobromide, Guaifenesin, and Phenylephrine hydrochloride LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 United Exchange Corp. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 65923-633_2fd95da5-2608-4030-a124-4e16f9c0a824 65923-633 HUMAN OTC DRUG Family Care Cough and Cold Dextromethorphan hydrobromide, and Guaifenesin LIQUID ORAL 20150729 OTC MONOGRAPH FINAL part341 United Exchange Corp. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 40; 400 mg/10mL; mg/10mL N 20181231 65923-637_70332973-4a38-4a69-bab3-18c91a532664 65923-637 HUMAN OTC DRUG SoundBody Advanced Relief Dextarn 70, Polyethylene glycol 400, Povidone, Tetrahydrozoline HCI SOLUTION/ DROPS OPHTHALMIC 20141125 OTC MONOGRAPH FINAL part349 United Exchange Corp. DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 65923-644_dab231dc-834d-408c-ba82-a95a48f3ac7f 65923-644 HUMAN OTC DRUG SoundBody Long Lasting Lubricant Polyethylene glycol 400, Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20140226 OTC MONOGRAPH FINAL part349 United Exchange Corp. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 65923-655_5d978b52-4356-3d2e-e053-2991aa0ae0cb 65923-655 HUMAN OTC DRUG CVS Single Use Lubricant Eye Drops Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20160121 OTC MONOGRAPH FINAL part349 United Exchange Corp. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 65923-657_63658c76-de88-c04e-e053-2a91aa0ac711 65923-657 HUMAN OTC DRUG Restore Plus Single Vial Carboxmethylcellulose sodium SOLUTION/ DROPS OPHTHALMIC 20160101 OTC MONOGRAPH FINAL part349 United Exchange Corp. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20191231 65923-699_10e57f86-ebee-4705-9638-7b81f274b4a2 65923-699 HUMAN OTC DRUG SHOPKO HYDROCORTISONE WITH ALOE HYDROCORTISONE CREAM TOPICAL 20121231 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP HYDROCORTISONE 1 g/100g E 20171231 65923-700_c6d8df9e-06a7-4266-9b22-cfd91172120b 65923-700 HUMAN OTC DRUG PAIN RELIEF THERAPY PATCH MENTHOL PATCH TOPICAL 20130131 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP MENTHOL 750 mg/1 E 20171231 65923-701_dc5263cb-36f2-4900-a769-4804b5b35b60 65923-701 HUMAN OTC DRUG Extra Strength Pain Relief Therapy Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp MENTHOL 750 mg/1 N 20181231 65923-702_9b8e9fe9-a33d-4ad7-bf20-2c74227d4cca 65923-702 HUMAN OTC DRUG Extra Strength Pain Relief Therapy Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp MENTHOL 750 mg/1 N 20181231 65923-703_9d4634b7-c635-45d3-b003-ad87af8fc4c6 65923-703 HUMAN OTC DRUG Extra Strength Pain Relief Therapy Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp MENTHOL 750 mg/1 E 20171231 65923-704_593b7c85-4c0c-48a9-a148-91a38a84c943 65923-704 HUMAN OTC DRUG Extra Strength Pain Relief Therapy Menthol PATCH TOPICAL 20140828 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp MENTHOL 750 mg/1 E 20171231 65923-777_7efa7bd4-6f86-46bf-9ebc-2ca3fcc88edc 65923-777 HUMAN OTC DRUG SHOPKO HEMORRHOIDAL MINERAL OIL,PETROLATUM,PHENYLEPHRINE,SHARK LIVER OIL OINTMENT TOPICAL 20110321 OTC MONOGRAPH FINAL part346 UNITED EXCHANGE CORP. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL 140; 719; 2.5; 30 mg/g; mg/g; mg/g; mg/g E 20171231 65923-778_7c49c02b-3d97-4de7-8dc3-45b8a493a40c 65923-778 HUMAN OTC DRUG Shopko Hemorrhoidal Mineral Oil OINTMENT TOPICAL 20130630 OTC MONOGRAPH FINAL part346 United Exchange Corp MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/100g; mg/100g; mg/100g E 20171231 65923-802_ab346b45-079f-48c4-94ec-1ccb12ffd229 65923-802 HUMAN OTC DRUG FAMILY CARE MEDICATED HEMORRHOIDAL WITCH HAZEL CLOTH TOPICAL 20110720 OTC MONOGRAPH FINAL part346 UNITED EXCHANGE CORPORATION WITCH HAZEL 5 g/1 N 20181231 65923-807_4da68b98-6858-415e-850c-3ff2ef727ef6 65923-807 HUMAN OTC DRUG Coralite Ultra Antibacterial Deodorant TRICLOCARBAN SOAP TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333A United Exchange Corp TRICLOCARBAN .3 g/100g E 20171231 65923-831_4d439c48-8348-4de1-9cd4-b77c199adedb 65923-831 HUMAN OTC DRUG Coralite Antibacterial Moist Benzalkonium Chloride SOLUTION TOPICAL 20130926 OTC MONOGRAPH NOT FINAL part333A United Exchange Corp. BENZALKONIUM CHLORIDE .115 g/1 N 20181231 65923-843_638a4320-9c1b-4122-e053-2991aa0af758 65923-843 HUMAN OTC DRUG Systane Ultra Single Vials Polyethylene Glycol and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20170102 OTC MONOGRAPH FINAL part349 United Exchange Corp. PROPYLENE GLYCOL; POLYETHYLENE GLYCOL 400 3; 4 mg/mL; mg/mL N 20191231 65923-901_44ebfbf1-aa96-491c-b3ef-19018d6856a4 65923-901 HUMAN OTC DRUG FAMILY CARE BACK PAIN THERAPY CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM OLEORESIN PATCH TOPICAL 20111227 OTC MONOGRAPH NOT FINAL part348 UNITED EXCHANGE CORP CAMPHOR (SYNTHETIC); MENTHOL; CAPSICUM OLEORESIN 80; 24; 16 mg/1; mg/1; mg/1 N 20181231 65923-977_29fd623b-37fe-4e11-b5af-3559cfc0be2a 65923-977 HUMAN OTC DRUG SHOPKO EXTRA MOISTURIZING NASAL OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20120301 OTC MONOGRAPH FINAL part341 UNITED EXCHANGE CORP. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL E 20171231 65923-978_4b0980e0-b345-4c32-9458-cedb3b9224aa 65923-978 HUMAN OTC DRUG SHOPKO SEVERE CONGESTION NASAL OXYMETAZOLINE HCL SPRAY NASAL 20120301 OTC MONOGRAPH FINAL part341 UNITED EXCHANGE CORP. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL E 20171231 65923-987_63006bb5-76e9-eb64-e053-2991aa0a95ad 65923-987 HUMAN OTC DRUG Family Care Muscle Rub Camphor, Menthol, and Methyl Salicylate CREAM TOPICAL 20180117 OTC MONOGRAPH NOT FINAL part348 United Exchange Corp. CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g N 20191231 65952-575_bfe45b6f-c017-4514-9e29-6391641b92f6 65952-575 HUMAN OTC DRUG Sani Guard Alcohol Free BENZETHONIUM CHLORIDE LIQUID TOPICAL OTC MONOGRAPH NOT FINAL part333 DEM Technology, LLC BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 65954-002_ddb01802-192a-4338-9c6a-c21bae7df346 65954-002 HUMAN OTC DRUG Colgate Total Whitening Sodium Fluoride and Triclosan GEL, DENTIFRICE DENTAL 20091001 NDA NDA020231 Mission Hills, S.A. de C.V. SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g E 20171231 65954-003_57e6ce72-21c2-4eb4-88de-b03877bf0191 65954-003 HUMAN OTC DRUG Colgate Total Whitening Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20091001 NDA NDA020231 Mission Hills, S.A. de C.V. SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g E 20171231 65954-007_5b238118-7618-4de8-9426-a81418c86aa7 65954-007 HUMAN OTC DRUG Colgate Sparkling White Mint Zing SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110820 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 65954-007_7dda1560-4137-46dd-9e50-8110b003ee70 65954-007 HUMAN OTC DRUG Colgate Sparkling White Mint Zing SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110720 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 65954-007_a94dbdfa-6e2a-4293-bb1b-8b250e8de0bc 65954-007 HUMAN OTC DRUG Colgate Sparkling White Mint Zing SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110820 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 65954-007_e8d21624-c8f2-4ef5-b4eb-94ea0875da99 65954-007 HUMAN OTC DRUG Colgate Sparkling White Mint Zing SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110820 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 65954-008_c238f343-c238-4e47-bf05-9a0b972d5729 65954-008 HUMAN OTC DRUG COLGATE SPARKLING WHITE CINNAMINT SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-010_b0f36912-2fc2-4f65-b72c-72255276ec13 65954-010 HUMAN OTC DRUG Colgate MaxFresh Fresh Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20130108 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-013_a857ebc0-d4b8-431d-a8fb-037eb8a59637 65954-013 HUMAN OTC DRUG Colgate Max Fresh Clean Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110801 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-014_bc6f83cc-b8b6-4a33-ac14-f55a243bc692 65954-014 HUMAN OTC DRUG Colgate Max Fresh Cool Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110801 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-022_3c1317de-fd30-4a2e-97fd-0f96cd4b27b8 65954-022 HUMAN OTC DRUG Colgate Luminous Crystal Fluoride SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20091103 OTC MONOGRAPH FINAL part355 Mission Hills S.A. de C.V. SODIUM FLUORIDE 1.1 mg/g E 20171231 65954-023_0ca4d1b9-2888-4fcc-a8b6-9728257ac1fa 65954-023 HUMAN OTC DRUG Colgate Fresh Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20130508 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-036_3dc7fed9-18da-4638-9a99-4cd92222d52c 65954-036 HUMAN OTC DRUG COLGATE KIDS WATERMELON FLAVOR SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-037_15a6a29c-aa27-48a3-b256-41dd62faa9ea 65954-037 HUMAN OTC DRUG COLGATE KIDS 2IN1 STRAWBERRY SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-038_01fe7a1e-7d3f-4ea1-bae6-dd886531786b 65954-038 HUMAN OTC DRUG COLGATE 2IN1 WHITENING STAIN LIFTERS SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-041_043786ef-d0f0-49dd-9edb-40f9575925e0 65954-041 HUMAN OTC DRUG COLGATE MAX WHITE WITH MINI BRIGHT STRIPS CRYSTAL MINT SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-042_b2a2ce67-82f6-4d0a-81ed-df8e5493a1f2 65954-042 HUMAN OTC DRUG Colgate Max White Crystal Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20090127 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-044_e3fac013-0dfd-4914-9b62-651b5c8f3d01 65954-044 HUMAN OTC DRUG Colgate Sensitive Enamel Protect SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20101130 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V SODIUM FLUORIDE; POTASSIUM NITRATE 1.1; 50 mg/g; mg/g N 20181231 65954-046_32a2782e-4591-4edf-9015-7f2f5cbaa77d 65954-046 HUMAN OTC DRUG Colgate Sensitive Multiprotection SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20100112 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE; POTASSIUM NITRATE 1.1; 50 mg/g; mg/g N 20181231 65954-046_4aec6fb0-d3a3-4eee-93ff-f65a1a0d7fcb 65954-046 HUMAN OTC DRUG Colgate Sensitive Multiprotection SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20100621 OTC MONOGRAPH FINAL part355 Mission Hills S.A. de C.V. SODIUM FLUORIDE; POTASSIUM NITRATE 2.4; 50 mg/g; mg/g N 20181231 65954-047_cec8e0bc-1503-4bdb-a02c-b54522c4166b 65954-047 HUMAN OTC DRUG Colgate Max White Polar Rush SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM FLUORIDE 2.4 mg/g N 20181231 65954-049_dcae866b-a388-46cc-988d-6e5e271e58fd 65954-049 HUMAN OTC DRUG COLGATE SENSITIVE SMARTFOAM WITH WHITENING POTASSIUM NITRATE and SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130501 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g N 20181231 65954-060_849eda5f-cd12-4556-b014-aaae286b4b95 65954-060 HUMAN OTC DRUG COLGATE Great Regular Flavor SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20051105 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 65954-062_eae85be7-a7c8-4fbe-be2e-63113feda71d 65954-062 HUMAN OTC DRUG Colgate MaxFresh CoolScrub Mintblast with Whitening SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20130522 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-063_2ebfd20c-fcbd-4c24-ad20-7ac2edbff539 65954-063 HUMAN OTC DRUG Colgate ULTRA BRITE Baking Soda and Peroxide Whitening SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 65954-064_5c3c95a7-ddd7-4562-8d0f-ddf47c2b47b1 65954-064 HUMAN OTC DRUG COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINT SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20051116 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-065_583f015c-7bc4-4494-a541-cb01f078622c 65954-065 HUMAN OTC DRUG Colgate Kids Mild Bubble Fruit Flavor SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20161111 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-068_fb7106a1-ed6e-4230-82bc-118638fa639c 65954-068 HUMAN OTC DRUG Colgate Sparkling White Mint Zing SODIUM MONOFLUOROPHOSPHATE GEL, DENTIFRICE DENTAL 20130301 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 65954-069_65bba2e3-f933-4d90-8f93-7c7df12464a3 65954-069 HUMAN OTC DRUG Colgate Turtles Mild Bubble Fruit SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130604 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-070_69c69489-2d8d-4385-8325-8b13245a96b9 65954-070 HUMAN OTC DRUG Colgate Monster High Mild Bubble Fruit SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130604 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-082_aab1c6c9-01e0-4b5d-ab4f-7c4520fffde9 65954-082 HUMAN OTC DRUG COLGATE SENSITIVE WHITENING FRESH MINT POTASSIUM NITRATE and SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20151016 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g N 20181231 65954-083_71c62224-769a-4131-abf8-39b5d0c2f9e0 65954-083 HUMAN OTC DRUG COLGATE SENSITIVE SMART WHITE FRESH MINT POTASSIUM NITRATE and SODIUM FLUORIDE PASTE DENTAL 20151016 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g N 20181231 65954-162_54687a6a-b198-41b7-a781-6494ea7185bc 65954-162 HUMAN OTC DRUG Colgate Tartar Control Whitening Crisp Mint SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20110108 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-167_257a35cb-ae56-4a96-8227-fe7895ff0299 65954-167 HUMAN OTC DRUG Colgate Optic White High Impact Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20150901 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 65954-327_f0a98511-7787-4a3c-badc-8e5a3782ff63 65954-327 HUMAN OTC DRUG Colgate Junior Bubble Fruit SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20161111 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-353_34312b6f-36d6-4352-8222-975b6a72b333 65954-353 HUMAN OTC DRUG Colgate Total Advanced Clean SODIUM FLUORIDE and TRICLOSAN PASTE, DENTIFRICE DENTAL 20090707 NDA NDA020231 Colgate-Palmolive Company SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g E 20171231 65954-354_08a0db89-03a1-4178-85bb-43ac057d3b30 65954-354 HUMAN OTC DRUG Colgate Total Advanced Clean SODIUM FLUORIDE and TRICLOSAN GEL, DENTIFRICE DENTAL 20090707 NDA NDA020231 Colgate-Palmolive Company SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g E 20171231 65954-355_ed98c7e9-265c-4a47-8bd8-b65bf7d43f47 65954-355 HUMAN OTC DRUG COLGATE 2IN1 ICY BLAST SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-358_36f04289-797a-466a-b346-4b05c4f8ecce 65954-358 HUMAN OTC DRUG Colgate Sensitive Maximum Strength Whitening SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A. de C.V. SODIUM FLUORIDE; POTASSIUM NITRATE 1.1; 50 mg/g; mg/g N 20181231 65954-372_b7a458ae-3b71-4f12-ac17-6df6d927a14c 65954-372 HUMAN OTC DRUG COLGATE 2IN1 OXYGEN WHITENING COOL MINT FLUORIDE SODIUM MONOFLUOROPHOSPHATE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 65954-381_4fc4a24d-a1af-4c9d-983c-460a07b7e1cb 65954-381 HUMAN OTC DRUG Colgate Max Clean Effervescent Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110318 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-382_edcebd1a-c533-4b59-aae7-1be68435d603 65954-382 HUMAN OTC DRUG Colgate Max Clean Spearmint Blast SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110801 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-385_c5b16209-af6f-414f-9f48-a01953e26ecd 65954-385 HUMAN OTC DRUG Colgate Optic White Beauty Radiant SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20161017 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 65954-400_69b40dae-a5a1-4df8-88e5-2a08ce97be0f 65954-400 HUMAN OTC DRUG Colgate Optic White Beauty Radiant SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20161220 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 65954-401_9f3d1c41-3ab4-470d-90f0-0788c5cdffd4 65954-401 HUMAN OTC DRUG Colgate Sensitive Lasting Fresh Mint Burst POTASSIUM NITRATE and SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20170304 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.1 mg/g; mg/g N 20181231 65954-402_d8849a67-f99a-4195-91bd-3a20748fc6a7 65954-402 HUMAN OTC DRUG Colgate Optic White Stain Fighter Fresh Mint SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20171130 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1 mg/g N 20181231 65954-403_ade7dd78-906b-49e5-ba29-5c5f48e632c1 65954-403 HUMAN OTC DRUG Colgate Optic White Stain Fighter Clean Mint SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20171130 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1 mg/g N 20181231 65954-504_0ed9700c-f5c3-46d4-bcd6-8ee264024d4b 65954-504 HUMAN OTC DRUG Colgate Kids Halloween Wicked Watermelon SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20110726 OTC MONOGRAPH FINAL part355 Mission Hills S.A. de C.V. SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-531_085af535-6ec3-4d4d-80a3-4e299f3dbb1d 65954-531 HUMAN OTC DRUG Colgate Junior Sponge Bob SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-534_8de3c2ea-e011-42d1-9add-19d9efd7b675 65954-534 HUMAN OTC DRUG Colgate Junior Dora SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-536_f33f9e54-f5b1-4882-8633-610f40a69f51 65954-536 HUMAN OTC DRUG Colgate Triple Action SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20101201 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-538_20796620-2be2-4af7-a462-63f9e03cb3c6 65954-538 HUMAN OTC DRUG Colgate Winter Watermelon Flavor SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20121101 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-545_caf8de03-0b06-4636-89a9-e4dd833734a4 65954-545 HUMAN OTC DRUG Colgate Jr Littlest Pet Shop SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM FLUORIDE .24 mg/g E 20171231 65954-547_5eff59e9-d140-4ba6-a3f8-7d4e935895c4 65954-547 HUMAN OTC DRUG Colgate Junior Transformers SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM FLUORIDE .24 mg/g E 20171231 65954-548_2ff17e33-f2c0-4353-b474-7a0eb972628f 65954-548 HUMAN OTC DRUG Colgate Sensitive Pro Relief Whitening SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20100906 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V SODIUM FLUORIDE; POTASSIUM NITRATE 1.1; 50 mg/g; mg/g N 20181231 65954-549_206d36f2-755e-45da-b911-199919707c26 65954-549 HUMAN OTC DRUG Colgate Sensitive Pro Relief SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20100906 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V SODIUM FLUORIDE; POTASSIUM NITRATE 1.1; 50 mg/g; mg/g N 20181231 65954-552_5865db43-dc6f-4da4-a1f1-3c24ed65be33 65954-552 HUMAN OTC DRUG Colgate Optic White Sparkling Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20111208 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 65954-553_6b419ae1-bf23-44c6-b8c0-a5afda8f5aa4 65954-553 HUMAN OTC DRUG Colgate Sensitive Pro Relief Enamel Repair SODIUM MONOFLUOROPHOSPHATE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20110112 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE; POTASSIUM NITRATE 1.5; 50 mg/g; mg/g N 20181231 65954-554_a19871fe-1e30-41f3-b98a-3906b3e86e4f 65954-554 HUMAN OTC DRUG Colgate Max Fresh Intense SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111208 OTC MONOGRAPH FINAL part355 Mission Hills S.A. de C.V. SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-556_7d3a66c5-9498-41c7-982a-cf976539c319 65954-556 HUMAN OTC DRUG Colgate Junior Fresh Protect SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20111201 OTC MONOGRAPH FINAL part355 Mission Hills, S.A.de C.V. SODIUM FLUORIDE .24 mg/g E 20171231 65954-559_affb597b-0812-4163-9e10-4f26783a40aa 65954-559 HUMAN OTC DRUG Colgate Cavity Protection SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20120225 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g E 20171231 65954-560_59358456-751a-40ef-ad08-8a999653e803 65954-560 HUMAN OTC DRUG Colgate Optic White Cool Mild Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20130102 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 65954-560_889e3730-c9d4-475a-8ff2-60e21fab33b0 65954-560 HUMAN OTC DRUG Colgate Optic White Cool Mild Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20120101 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 65954-561_e47cdc8f-dd2c-4aaf-8951-27ec66e16321 65954-561 HUMAN OTC DRUG Colgate Optic White Enamel White SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20120625 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g E 20171231 65954-563_a2b80a64-ee9f-4d42-bc0c-f824f5438864 65954-563 HUMAN OTC DRUG Colgate Optic White Dual Action Crystal Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20121220 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 65954-564_11d0b755-0233-46b7-a668-d6a538ec2f24 65954-564 HUMAN OTC DRUG Colgate Max Fresh Cool Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20080406 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-580_86eb79cc-2b46-4eae-9c91-9bd09767d51f 65954-580 HUMAN OTC DRUG Colgate Advanced Sensitive Plus Whitening SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20121223 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V SODIUM FLUORIDE; POTASSIUM NITRATE 1.1; 50 mg/g; mg/g N 20181231 65954-584_c1a0c979-23db-4774-b933-a92e145fd7a3 65954-584 HUMAN OTC DRUG Colgate Fresh N Protect Mild Mint SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20120106 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-587_12a3ce6b-3b92-4801-988d-29ac27f0ad2d 65954-587 HUMAN OTC DRUG Colgate Optic White Platinum Crystal Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131118 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 65954-588_bde04a53-8166-48f2-8b97-ff1cdf3f6f1f 65954-588 HUMAN OTC DRUG Colgate Optic White Platinum Cool Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131118 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 65954-589_97147733-fe2b-4382-aa14-50812ff79968 65954-589 HUMAN OTC DRUG Colgate Optic White Platinum Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20150701 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1.1 mg/g N 20181231 65954-591_8eb430a7-1a7e-4f3f-8341-a8f95d762ece 65954-591 HUMAN OTC DRUG Colgate Cavity Protection SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20140406 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-592_d6f56ec2-9b9a-417f-8809-eaf10654a7b6 65954-592 HUMAN OTC DRUG Colgate Fluoride - Trolls - Mild Bubble Fruit SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20160630 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-593_948e49c3-cad0-447e-ad52-e1a08e19a67b 65954-593 HUMAN OTC DRUG Colgate Fluoride - Blaze - Mild Bubble Fruit SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20160630 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-596_dff66401-46af-4e71-8236-94bc68802e4d 65954-596 HUMAN OTC DRUG Colgate Fluoride Toothpaste-Peppa Pig-Mild Bubble Fruit SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20170710 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-607_c0dced0b-f8f0-43bd-8aaa-f1af1f59ad42 65954-607 HUMAN OTC DRUG Colgate Junior Mixed Kids Bubble Fruit Fluoride SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20170626 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-765_9a0d7d9e-a571-43f5-b7e2-3fcef64a6b18 65954-765 HUMAN OTC DRUG COLGATE Baking Soda and Peroxide Whitening Brisk Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110820 OTC MONOGRAPH FINAL part355 Mission Hills, S.A. de C.V. SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 65954-768_aa57ebe5-7f59-43f7-9913-9a8008392984 65954-768 HUMAN OTC DRUG Colgate Baking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110820 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 65954-769_14cba09e-0f3a-4468-8740-5600e579498d 65954-769 HUMAN OTC DRUG Colgate Optic White Icy Fresh Cool Fresh Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131118 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 65954-770_967df5ca-3fb2-4b2f-9aee-44fecb5d726a 65954-770 HUMAN OTC DRUG Colgate Sensitive Prevent and Repair SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20131218 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V SODIUM FLUORIDE; POTASSIUM NITRATE 1.1; 50 mg/g; mg/g N 20181231 65954-771_124990c7-adef-4622-b0c2-a28597945140 65954-771 HUMAN OTC DRUG Colgate Optic White Sparkling Mint Flavor SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131218 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 65954-772_c5513d42-1b79-4e21-9898-a7db40eb72d3 65954-772 HUMAN OTC DRUG Colgate Optic White Enamel White Luminous Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131218 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g N 20181231 65954-773_c3e55aed-5e54-457c-86cc-65ec2fada675 65954-773 HUMAN OTC DRUG Colgate Sensitive Complete Protection SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20131218 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V SODIUM FLUORIDE; POTASSIUM NITRATE 1.1; 50 mg/g; mg/g N 20181231 65954-774_a301c256-8fed-4063-b7e0-378841faaaf3 65954-774 HUMAN OTC DRUG Colgate Optic White Platinum Express White Fresh Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141031 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 65954-775_b30eb1af-1ede-43bb-97d3-9477fca3b939 65954-775 HUMAN OTC DRUG Colgate MaxFresh Anticavity Fluoride Electric Mint SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20141031 OTC MONOGRAPH FINAL part355 Mission Hills, S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-776_3795d44d-ac49-47ba-80da-9c789bb99d46 65954-776 HUMAN OTC DRUG Colgate Sensitive Maximum Strength Mint Clean SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE DENTAL 20140105 OTC MONOGRAPH NOT FINAL part356 Mission Hills S.A de C.V SODIUM FLUORIDE; POTASSIUM NITRATE 1.1; 50 mg/g; mg/g N 20181231 65954-777_551e6f5c-d91c-4c94-a005-464af0d2be83 65954-777 HUMAN OTC DRUG Colgate Deep Clean Fluoride SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20150129 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-778_775cde9e-0549-4a76-b64a-50de3aaa3a4e 65954-778 HUMAN OTC DRUG Colgate Advanced Whitening Fluoride SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20150129 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-779_c0c097d4-9d86-43e0-8dc8-6d6434f36e82 65954-779 HUMAN OTC DRUG Colgate Minions Mild Bubble Fruit Fluoride SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20150312 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-780_1e7439a6-9566-4a3a-b626-d004260bff63 65954-780 HUMAN OTC DRUG Colgate MaxFresh with Whitening KnockOut Fluoride SODIUM FLUORIDE GEL, DENTIFRICE DENTAL 20160105 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM FLUORIDE 1.1 mg/g N 20181231 65954-785_f2ea058b-a791-4f45-8f95-ae9a3544167b 65954-785 HUMAN OTC DRUG Colgate Optic White Platinum Stain-Less SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20171114 OTC MONOGRAPH FINAL part355 Mission Hills S.A de C.V SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 65954-900_36dbcd71-676d-41b4-b344-6e0f1ab3cba1 65954-900 HUMAN OTC DRUG Speed Stick 24/7 Fresh Rush ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20120401 OTC MONOGRAPH FINAL part350 Mission Hills S.A de C.V ALUMINUM CHLOROHYDRATE .1128 g/mL N 20181231 65954-901_a4995a3e-59eb-46d3-9ab3-b239a49c053d 65954-901 HUMAN OTC DRUG Lady Speed Stick 24/7 Fresh Fusion ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20120401 OTC MONOGRAPH FINAL part350 Mission Hills S.A de C.V ALUMINUM CHLOROHYDRATE .1128 g/mL N 20181231 65966-001_edabc2ce-e1c0-4db5-9d14-46294e20d231 65966-001 HUMAN OTC DRUG LA MER THE TREATMENT FLUID FOUNDATION SPF 15 TITANIUM DIOXIDE OCTINOXATE LIQUID TOPICAL 20000901 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC TITANIUM DIOXIDE; OCTINOXATE 4.7; 2.2 mL/100mL; mL/100mL N 20181231 65966-009_56070748-6ce4-4c1b-826c-d704245d9528 65966-009 HUMAN OTC DRUG LA MER THE SPF 30 UV PROTECTING FLUID ZINC OXIDE, OCTINOXATE LIQUID TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC ZINC OXIDE; OCTINOXATE 10; 7.5 mL/100mL; mL/100mL N 20181231 65966-010_a75e9378-d2a7-42e9-955a-558f5f84a1f7 65966-010 HUMAN OTC DRUG THE RADIANT CONCEALER SPF 15 TITANIUM DIOXIDE CREAM TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC TITANIUM DIOXIDE 4.65 g/100g E 20171231 65966-011_708d9bb3-dcae-4afc-b8dd-51091774a325 65966-011 HUMAN OTC DRUG LA MER THE REPARATIVE FACE SUN Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20121111 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0312; .052; .052; .02808; .0312 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 65966-014_51797e8c-f078-4b37-a379-cac675095e17 65966-014 HUMAN OTC DRUG LA MER THE REPARATIVE BODY SUN Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0312; .052; .052; .02808; .0312 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 65966-015_f86db674-f483-486c-9969-4378d033b861 65966-015 HUMAN OTC DRUG THE RADIANT CONCEALER BROAD SPECTRUM SPF 25 Titanium Dioxide CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC TITANIUM DIOXIDE 3.5 g/100g N 20181231 65966-016_30c27a5d-5c99-464f-988e-6ee341a267a1 65966-016 HUMAN OTC DRUG LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE LOTION TOPICAL 20130505 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .0312; .052; .052; .02808; .0312 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 65966-017_49c5eb94-d0bd-4122-bb0a-6ea95e13f958 65966-017 HUMAN OTC DRUG LA MER THE REPARATIVE SKIN TINT BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE LOTION TOPICAL 20150210 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .0825; .022; .053 g/100mL; g/100mL; g/100mL N 20181231 65966-018_dd6edccf-a3ca-4a35-b486-913fed8dffbc 65966-018 HUMAN OTC DRUG THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20 OCTINOXATE and TITANIUM DIOXIDE LIQUID TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC OCTINOXATE; TITANIUM DIOXIDE .0795; .02014 g/mL; g/mL N 20181231 65966-111_0ef63975-eca4-41b6-a80c-0bafc0019d5a 65966-111 HUMAN OTC DRUG THE TREATMENT POWDER FOUNDATION SPF 15 TITANIUM DIOXIDE, OCTINOXATE POWDER TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC TITANIUM DIOXIDE; OCTINOXATE 4.9; 4.5 g/100g; g/100g E 20171231 65966-918_4eea5e21-1fc9-4259-aeb0-9642cb92477d 65966-918 HUMAN OTC DRUG THE SPF 18 FLUID TINT OCTINOXATE, HOMOSALATE, and AVOBENZONE LOTION TOPICAL 20050601 OTC MONOGRAPH NOT FINAL part352 MAX HUBER RESEARCH LAB INC OCTINOXATE; HOMOSALATE; AVOBENZONE 7.5; 3.5; 3 mL/100mL; mL/100mL; mL/100mL E 20171231 65976-100_007e4377-c959-45b6-b374-5de8f0572d5f 65976-100 HUMAN PRESCRIPTION DRUG Arestin Minocycline Hydrochloride POWDER ORAL 20110321 NDA NDA050781 OraPharma, Inc. MINOCYCLINE HYDROCHLORIDE 1 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 65977-5025_61788ac8-2837-4419-942d-cb47143c95f2 65977-5025 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20100607 ANDA ANDA090061 Hetero Drugs Limited FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 65977-5033_98457ee9-35be-4d2f-84c2-b3283e553bbd 65977-5033 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20091106 ANDA ANDA090200 Hetero Drugs Limited Unit III METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 65977-5034_98457ee9-35be-4d2f-84c2-b3283e553bbd 65977-5034 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20091106 ANDA ANDA090200 Hetero Drugs Limited Unit III METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 65977-5036_b9acd365-1b80-4428-bd33-3a5eac814677 65977-5036 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101008 ANDA ANDA090515 Hetero Drugs Ltd., LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 65977-5037_b9acd365-1b80-4428-bd33-3a5eac814677 65977-5037 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101008 ANDA ANDA090515 Hetero Drugs Ltd., LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 65977-5038_b9acd365-1b80-4428-bd33-3a5eac814677 65977-5038 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101008 ANDA ANDA090515 Hetero Drugs Ltd., LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 65977-5039_b9acd365-1b80-4428-bd33-3a5eac814677 65977-5039 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101008 ANDA ANDA090515 Hetero Drugs Ltd., LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 65977-5042_110aada7-dfe8-4ecf-80c7-4dac8907ad29 65977-5042 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20110412 ANDA ANDA091240 Hetero Drugs Ltd., INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 65977-5043_110aada7-dfe8-4ecf-80c7-4dac8907ad29 65977-5043 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20110412 ANDA ANDA091240 Hetero Drugs Ltd., INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 65977-5044_5d414505-02dd-40a0-8777-cc798088b6dd 65977-5044 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090925 ANDA ANDA090702 Hetero Drugs Limited LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] E 20171231 65977-5045_5d414505-02dd-40a0-8777-cc798088b6dd 65977-5045 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090925 ANDA ANDA090702 Hetero Drugs Limited LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 65977-5046_5d414505-02dd-40a0-8777-cc798088b6dd 65977-5046 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090925 ANDA ANDA090702 Hetero Drugs Limited LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] E 20171231 66007-101_ab6c70b9-dfdb-498f-ae0b-07e59f8398f5 66007-101 HUMAN OTC DRUG Zinc Cold Remedy Fast Melting zinc acetate and zinc gluconate TABLET ORAL 20150206 UNAPPROVED HOMEOPATHIC Izeen Pharma, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 66007-103_a2f36978-5282-4e46-b79a-5a593bdf65c3 66007-103 HUMAN OTC DRUG Ultra Cold Remedy Rapidmelts zinc acetate and zinc gluconate TABLET ORAL 20150206 UNAPPROVED HOMEOPATHIC Izeen Pharma, Inc. ZINC ACETATE; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 66007-145_a7e74856-eb57-4153-bae9-008f0cfdbbf9 66007-145 HUMAN OTC DRUG Junior Strength Pain Relief Acetaminophen TABLET ORAL 20100726 OTC MONOGRAPH NOT FINAL part343 Capricorn Pharma Inc. ACETAMINOPHEN 160 mg/1 E 20171231 66007-204_bfb607f0-1c6a-470c-ad3b-933b3f5897f4 66007-204 HUMAN OTC DRUG Expectorant plus Cough Relief Guaifenesin and Dextromethorphan GRANULE ORAL 20100806 OTC MONOGRAPH FINAL part341 Capricorn Pharma Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/1; mg/1 E 20171231 66007-212_557a995c-3fe4-411c-94ef-f6d4f1bd0a55 66007-212 HUMAN OTC DRUG Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20100929 OTC MONOGRAPH FINAL part341 Capricorn Pharma Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 E 20171231 66010-515_edcab71e-e03a-485e-8e50-839d883102c4 66010-515 HUMAN OTC DRUG American Continental Techlabs, LLC INSTANT HAND SANITIZER ethanol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 American Continental Techlabs ETHANOL 600 mL/1000mL E 20171231 66019-304_1b901d34-b979-4a9f-9200-297c290e8406 66019-304 VACCINE FluMist Quadrivalent Influenza Vaccine Live Intranasal SPRAY NASAL 20170825 BLA BLA125020 MedImmune, LLC INFLUENZA A VIRUS A/SLOVENIA/2903/2015 (H1N1) LIVE (ATTENUATED) ANTIGEN; INFLUENZA A VIRUS A/NEW CALEDONIA/71/2014 (H3N2) LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/PHUKET/3073/2013 LIVE (ATTENUATED) ANTIGEN; INFLUENZA B VIRUS B/BRISBANE/60/2008 LIVE (ATTENUATED) ANTIGEN 10000000; 10000000; 10000000; 10000000 [FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL; [FFU]/.2mL N 20181231 66051-011_a08351ae-5124-40f4-8651-fdb521cb9acd 66051-011 HUMAN OTC DRUG Haws Personal Emergency Eyewash - DUO Saline Water LIQUID OPHTHALMIC 20160623 OTC MONOGRAPH FINAL part349 Haws Corporation WATER 99.1 mL/100mL N 20181231 66051-022_70783303-0722-450b-9272-f51adcb12a7d 66051-022 HUMAN OTC DRUG Haws Personal Emergency Eyewash - DUO pH Neutral Water LIQUID OPHTHALMIC 20160623 OTC MONOGRAPH FINAL part349 Haws Corporation WATER 95.1 mL/100mL N 20181231 66051-210_9d6dc4cb-ee23-4286-bddc-a8c59df112c4 66051-210 HUMAN OTC DRUG Haws Eyewash Additive purified water SOLUTION, CONCENTRATE CUTANEOUS; IRRIGATION; OPHTHALMIC; TOPICAL 20140703 OTC MONOGRAPH FINAL part349 Haws Corporation WATER 889.6 g/1000mL N 20181231 66059-0001_d521df41-f102-4176-acc5-91dda4f437a5 66059-0001 HUMAN OTC DRUG RAMEDICA RAMEDICA OINTMENT TOPICAL 20001213 OTC MONOGRAPH NOT FINAL part348 Ramedicare Sdn. Bhd. CAMPHOR (SYNTHETIC); METHYL SALICYLATE; EUCALYPTUS OIL; MENTHOL 2.53; 2.3; 2.3; 1.84 g/g; g/g; g/g; g/g E 20171231 66059-0002_3d2fa5ff-c4f0-4f08-b07a-f8eeb5392fb2 66059-0002 HUMAN OTC DRUG RAMEDICA RAMEDICA OINTMENT TOPICAL 20180123 OTC MONOGRAPH NOT FINAL part348 Ramedicare Sdn. Bhd. CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL; PEPPERMINT OIL 12; 7; 11; 6 g/100g; g/100g; g/100g; g/100g N 20191231 66077-773_812707d0-433f-4f50-921c-48b64b5726f2 66077-773 HUMAN OTC DRUG Instant Foam ALCOHOL AEROSOL, FOAM TOPICAL 20100301 OTC MONOGRAPH NOT FINAL part333 Ultra-Chem Inc. ALCOHOL 620 mg/g E 20171231 66078-033_b558a27e-dcde-4ccd-a82c-d6c2a091a538 66078-033 HUMAN OTC DRUG Benzoyl Peroxide Benzoyl Peroxide GEL TOPICAL 20010923 OTC MONOGRAPH FINAL part333D MD Formulation BENZOYL PEROXIDE 10 g/100g E 20171231 66078-035_6e906461-55a1-4620-9406-c0f50cf9d221 66078-035 HUMAN OTC DRUG Glycare Acne Glycolic Acid GEL TOPICAL 20011007 OTC MONOGRAPH FINAL part333D MD Formulation SALICYLIC ACID 1 g/100g E 20171231 66078-110_c3fad29a-9dc1-4a2d-9bb1-3d745068b4d2 66078-110 HUMAN OTC DRUG Total Protrector 15 Octinoxate, Zinc Oxide CREAM TOPICAL 20070708 OTC MONOGRAPH NOT FINAL part352 MD Formulation OCTINOXATE; ZINC OXIDE 7.5; 4.9 g/100g; g/100g E 20171231 66078-368_53a19b28-930b-45b1-ac78-aba6f64f8bd7 66078-368 HUMAN OTC DRUG Total Protector 30 Zinc Oxide,Octinaxade,Octisalate CREAM TOPICAL 20011213 OTC MONOGRAPH FINAL part352 MD Formulation ZINC OXIDE; OCTINOXATE; OCTISALATE 7.8; 7.5; 4 g/100g; g/100g; g/100g E 20171231 66078-440_73126032-358a-46f5-b86d-e69c5a355836 66078-440 HUMAN OTC DRUG Sun Total Protector 30 broad spectrum SPF 30 daily protection Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20120815 OTC MONOGRAPH NOT FINAL part352 MD Formulation. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 4; 7.8 g/100g; g/100g; g/100g E 20171231 66078-503_a6cc9a25-ad18-4d07-8efa-8ef185552e6f 66078-503 HUMAN OTC DRUG Sun Total Protector Color 30 Light Tint Zinc Oxide, Octisalate, Octinoxate CREAM TOPICAL 20070520 OTC MONOGRAPH NOT FINAL part352 MD Formulations ZINC OXIDE; OCTISALATE; OCTINOXATE 7.8; 4; 7.5 mL/100mL; mL/100mL; mL/100mL E 20171231 66078-504_22437a1e-58af-4812-a9c1-17c492077efd 66078-504 HUMAN OTC DRUG Total Protector Color 30 Medium Tint Octinoxate CREAM TOPICAL 20050128 OTC MONOGRAPH NOT FINAL part352 MD Formulation OCTINOXATE; ZINC OXIDE; OCTISALATE 7.5; 7.8; 4 g/100g; g/100g; g/100g E 20171231 66078-505_e95e2ede-4887-4900-ae8d-a1b8a1b9ec62 66078-505 HUMAN OTC DRUG Sun Total Protector Color 30 Dark Tint Sun Total Protector Color 30 Dark Tint CREAM TOPICAL 20070520 OTC MONOGRAPH NOT FINAL part352 MD Formulations ZINC OXIDE; OCTISALATE; OCTINOXATE 7.8; 4; 7.5 mL/100mL; mL/100mL; mL/100mL E 20171231 66083-741_fbfd6217-d2ac-4f10-b44d-1b35cea90f0b 66083-741 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Boone Drugs, Inc OXYGEN 99 L/100L E 20171231 66096-011_e971b7e2-87a8-4f47-a162-c4b64ee77067 66096-011 HUMAN OTC DRUG ANX-OHM Argentum Nitricum, Avena Sativa, Aurum Metallicum, Gelsemium, Hyosciamus Niger, Ignatia, Moschus, Natrum Muriaticum, Passiflora Incarnata, Stannum Metallicum, Valeriana Officinalis SPRAY ORAL 20100101 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. SILVER NITRATE; AVENA SATIVA FLOWERING TOP; GOLD; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS WHOLE; SODIUM CHLORIDE; PASSIFLORA INCARNATA TOP; TIN; VALERIAN 14; 5; 14; 14; 14; 14; 14; 14; 5; 16; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-114_457cf87e-7f76-46af-9553-68aaa59a0a5a 66096-114 HUMAN OTC DRUG Cold Aconitum Napellus, Bryonia Alba, Eupatorium Perfoliatum, Ferrum Phosphoricum, Gelsemium Sempervirens, Kali Bichromicum, Kali lodatum, Zincum Gluconicum. LIQUID ORAL 20170109 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ACONITUM NAPELLUS; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM DICHROMATE; POTASSIUM IODIDE; ZINC GLUCONATE 4; 6; 4; 4; 6; 6; 6; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-115_243fa0f3-e3f7-46dd-bce1-76bb52aacf6e 66096-115 HUMAN OTC DRUG Cough Relief Aconitum Nap, Antimon Crud, Antimon Sulph, Antimon Tart, Aralia Rac, Bryonia, Chelidonium Maj, Cuprum Met, Drosera, Hepar Sulph Calc, Kali Carb, Spongia. LIQUID ORAL 20150521 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ACONITUM NAPELLUS; ANTIMONY TRISULFIDE; ANTIMONY PENTASULFIDE; ANTIMONY POTASSIUM TARTRATE; ARALIA RACEMOSA ROOT; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; COPPER; DROSERA ROTUNDIFOLIA; CALCIUM SULFIDE; POTASSIUM CARBONATE; SPONGIA OFFICINALIS SKELETON, ROASTED 6; 8; 8; 8; 4; 6; 6; 12; 6; 12; 12; 6 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-116_da385d11-ee58-4e13-8bc7-635ad8a930f1 66096-116 HUMAN OTC DRUG OHM-DAM Agnus Castus, Avena Sativa, Damiana, Gelsemium Sempervirens, Ignatia Amara, Lycopodium Clavatum, Orchitinum, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Tribulus Terrestris, Yohimbinum SPRAY ORAL 20100101 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CHASTE TREE; AVENA SATIVA FLOWERING TOP; TURNERA DIFFUSA LEAFY TWIG; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; SUS SCROFA TESTICLE; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; TRIBULUS TERRESTRIS; YOHIMBINE 5; 5; 5; 14; 14; 14; 12; 14; 5; 12; 7; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-117_9b1db988-482a-4d32-b537-8e576f74875f 66096-117 HUMAN OTC DRUG OHM-DETL Boldo, Carduus Marianus, Chelidonium Majus, China Officinalis, Cynara Scolymus, Hydrastis Canadensis, Nux Vomica, Stannum Metallicum, Taraxacum Officinale SPRAY ORAL 20100101 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; GOLDENSEAL; STRYCHNOS NUX-VOMICA SEED; TIN; TARAXACUM OFFICINALE 5; 5; 5; 7; 5; 5; 7; 16; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-118_783bcf21-b905-426b-b0b2-5d850708bbf9 66096-118 HUMAN OTC DRUG OHM-DETK Apis Mellifica, Berberis Vulgaris, Chimaphila Umbellata, Cuprum Metallicum, Equisetum Hyemale, Formica Rufa, Sabal Serrulata, Sarsaparilla, Solidago SPRAY ORAL 20100101 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; CHIMAPHILA UMBELLATA; COPPER; EQUISETUM HYEMALE; FORMICA RUFA; SAW PALMETTO; SMILAX REGELII ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 5; 5; 5; 14; 7; 6; 5; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-119_58f46813-349f-4837-a276-4525a6583ed5 66096-119 HUMAN OTC DRUG OHM Immune Complex Adrenal Gland, Echinacea Angustifolia, Ferrum Phosphoricum, Kali Muriaticum, Liver Extractum, Pituitarum Posterium, Placenta Totalis Suis, Viscum Album. LIQUID ORAL 20160301 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. BOS TAURUS ADRENAL GLAND; ECHINACEA ANGUSTIFOLIA; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; MAMMAL LIVER; SUS SCROFA PITUITARY GLAND, POSTERIOR; SUS SCROFA PLACENTA; VISCUM ALBUM FRUITING TOP 8; 3; 6; 4; 8; 8; 8; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-120_9048160d-5fee-4a5b-ac46-b32a74a5c729 66096-120 HUMAN OTC DRUG OHM Fatigue Relief Aceticum Ac, Adrenal Gland, Arnica, Benzoicum Ac, Ferrum Phos, Fluoricum Ac, Ginseng, Kali Carb, Kali lod, Kali Mur, Kali Phos, Lacticum Ac, Phosphoricum Ac, Picricum Ac. LIQUID ORAL 20150521 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ACETIC ACID; BOS TAURUS ADRENAL GLAND; ARNICA MONTANA; BENZOIC ACID; FERROSOFERRIC PHOSPHATE; HYDROFLUORIC ACID; ASIAN GINSENG; POTASSIUM CARBONATE; POTASSIUM IODIDE; POTASSIUM CHLORIDE; DIBASIC POTASSIUM PHOSPHATE; LACTIC ACID, DL-; PHOSPHORIC ACID; PICRIC ACID 30; 10; 12; 30; 6; 30; 3; 4; 3; 3; 3; 30; 30; 30 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-121_7394b528-d079-4f5f-9f9a-89f40f088bae 66096-121 HUMAN OTC DRUG OHM Fever Relief Aconitum Nap, Baptisia, Belladonna, Bryonia, Chamomilla, Eupatorium Perf, Gelsemium, Rhus Tox. SPRAY ORAL 20120607 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ACONITUM NAPELLUS; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA CHAMOMILLA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF 6; 24; 6; 6; 4; 6; 5; 6 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-122_d4410167-1433-4273-9174-69ee599f7e48 66096-122 HUMAN PRESCRIPTION DRUG OHM Pituitarum Complex Adrenal Gland, Adrenocorticotrophin, Cerebrum, Liver Gland, Pituitarum Posterium Gland, Placenta, Thyroidinum. LIQUID ORAL 20170410 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. EPINEPHRINE; CORTICOTROPIN; SUS SCROFA CEREBRUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND, POSTERIOR; SUS SCROFA PLACENTA; THYROID, UNSPECIFIED 10; 10; 14; 10; 10; 8; 8 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] N 20181231 66096-123_5857e750-de09-42c3-bb60-4b8fe82c2e36 66096-123 HUMAN OTC DRUG OHM-INS Avena Sativa, Coffea Cruda, Ignatia Amara, Passiflora Incarnata, Valeriana Officinalis SPRAY ORAL 20100101 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA TOP; VALERIAN 5; 30; 14; 5; 5 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-125_665fedd4-517c-4567-94a8-8c256e37d902 66096-125 HUMAN OTC DRUG Weight Control Aceticum Ac, Anacard Or, Baryta Iod, Calc Carb, Capsicum, Fucus, Graphites,, Nat Sulphuricum, Phytolacca, Stannum Met, Thyroidinum, Zinc Met. SPRAY ORAL 20130930 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ACETIC ACID; SEMECARPUS ANACARDIUM JUICE; BARIUM IODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; FUCUS VESICULOSUS; GRAPHITE; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; TIN; THYROID, UNSPECIFIED; ZINC 10; 14; 12; 14; 14; 5; 14; 14; 7; 16; 12; 14 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-139_0501768e-ab53-40e0-b73f-c2d075136999 66096-139 HUMAN OTC DRUG OHM Skin Healing Gel Calendula Officinalis, Stellaria Media, Calcarea Sulphurica, Chamomilla, Echinacea Angustfolia, Silicea, Symphytum Officinale, Thiosinamium, Hamamelis Virginiana. GEL TOPICAL 20161116 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CALENDULA OFFICINALIS FLOWERING TOP; STELLARIA MEDIA; CALCIUM SULFATE ANHYDROUS; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; SILICON DIOXIDE; COMFREY ROOT; ALLYLTHIOUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1; 1; 3; 1; 1; 3; 6; 3; 1 [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g N 20181231 66096-143_8ab00f43-c32b-479e-88a3-c5fc28a012d8 66096-143 HUMAN OTC DRUG Anti Fungal Baptisia Tinctoria, Calendula Officinalis, Thuja Occidentalis. LIQUID ORAL 20160210 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. BAPTISIA TINCTORIA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 1; 1; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 66096-144_288c5be4-10ae-4c41-8d6b-6d014ed03587 66096-144 HUMAN OTC DRUG OHM Mucosa Cleanser Calendula Officinalis, Hydrastis Canadensis, Thuja Occidentalis. LIQUID NASAL 20110110 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CALENDULA OFFICINALIS FLOWERING TOP; GOLDENSEAL; THUJA OCCIDENTALIS LEAFY TWIG 1; 5; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 66096-153_b0aa3644-30cf-4a52-89f1-3f632ecda6e8 66096-153 HUMAN OTC DRUG OHM Pancreas Aid Helonias Dioica, Lacticum Acidum, Pancreas Suis, Pancreatinum, Phosphoricum Acidum, Phosphorus, Syzygium Jambolanum, Thyroidinum, Uranium Nitricum. LIQUID ORAL 20150803 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CHAMAELIRIUM LUTEUM ROOT; LACTIC ACID, DL-; SUS SCROFA PANCREAS; PANCRELIPASE; PHOSPHORIC ACID; PHOSPHORUS; SYZYGIUM CUMINI SEED; THYROID, UNSPECIFIED; URANYL NITRATE HEXAHYDRATE 30; 4; 8; 14; 10; 10; 3; 8; 12 [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-154_224aca62-edbb-4f77-9d6b-22acd9d3dfa8 66096-154 HUMAN OTC DRUG OHM Sore Throat Aconitum Nap, Ailanthus, Baptisia, Belladonna, Ferrum Phos, Hepar Sulph Calc, Hydrastis, Merc Cyan, Merc Iod Rub, Phytolacca. SPRAY SUBLINGUAL 20170410 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ACONITUM NAPELLUS; AILANTHUS ALTISSIMA FLOWERING TWIG; BAPTISIA TINCTORIA; ATROPA BELLADONNA; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; GOLDENSEAL; MERCURIC CYANIDE; MERCURIC IODIDE; PHYTOLACCA AMERICANA ROOT 7; 16; 3; 7; 6; 12; 3; 16; 8; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-156_96fffcaf-83f8-4ae6-b1bd-ae442d07c8fe 66096-156 HUMAN OTC DRUG OHM Menopause Ammonium Carbonicum, Amyl Nitrosum, Cimicifuga Racemosa, Glonoinum, Lachesis Mutus, Sanguinaria, Canadensis. LIQUID ORAL 20150819 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. AMMONIUM CARBONATE; AMYL NITRITE; BLACK COHOSH; NITROGLYCERIN; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT 12; 6; 3; 12; 12; 4 [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-157_a96bf5cf-bf86-4338-95b0-69fd8e2eb0d5 66096-157 HUMAN PRESCRIPTION DRUG OHM Parasites Chenopodium Anthelminticum, Cina, Cucurbita, Pepo, Cuprum Oxydatum Nigrum, Filix Mas, Granatum, Kousso, Ratanhia, Santoninum, Sabadilla, Spigelia, Teucrium Marum. LIQUID ORAL 20150819 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; PUMPKIN SEED; CUPRIC OXIDE; DRYOPTERIS FILIX-MAS ROOT; PUNICA GRANATUM ROOT BARK; HAGENIA ABYSSINICA FLOWER; KRAMERIA LAPPACEA ROOT; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SPIGELIA MARILANDICA ROOT; TEUCRIUM MARUM 6; 6; 3; 12; 4; 4; 7; 4; 10; 4; 4; 4 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-158_1b500454-cbf6-4fa2-8b79-9789e112f7f9 66096-158 HUMAN OTC DRUG ALLERGY RELIEF Allium Cepa, Apis Mellifica, Aralia Racemosa, Blatta Orientalis, Euphrasia Officinalis, Galphimia Glauca, Hedera Helix, Luffa Operculata, Okoubaka, Sabadilla. SPRAY ORAL 20150417 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; BLATTA ORIENTALIS; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; LUFFA OPERCULATA FRUIT; OKOUBAKA AUBREVILLEI BARK; SCHOENOCAULON OFFICINALE SEED 5; 5; 5; 5; 5; 5; 5; 5; 5; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66096-159_50986052-74ac-4e89-8141-1cb40adb568b 66096-159 HUMAN PRESCRIPTION DRUG OHM Mouthwash Arnica Montana, Borax, Calendula Officinalis, Hypericum Perforatum, Myrrha, Plantago Major, Ratanhia, Salvia Officinalis, Symphytum Officinale. LIQUID ORAL 20150915 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARNICA MONTANA; SODIUM BORATE; CALENDULA OFFICINALIS FLOWERING TOP; HYPERICUM PERFORATUM; MYRRH; PLANTAGO MAJOR; KRAMERIA LAPPACEA ROOT; SAGE; COMFREY ROOT 3; 3; 1; 3; 3; 1; 3; 1; 6 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient] N 20181231 66096-166_ee463fb7-f4f3-483e-a91b-c9bbde5d774c 66096-166 HUMAN OTC DRUG Kali Iodatum 1X Kali Iodatum. LIQUID ORAL 20160210 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. POTASSIUM IODIDE 1 [hp_X]/30mL N 20181231 66096-168_76989464-f9cf-46aa-be60-90c3d45fd41e 66096-168 HUMAN OTC DRUG Acne Relief Antimonium Crud, Arsenicum Brom, Bovista, Eugenia Jamb, Fluoricum Acidum, Hepar Sulph Calc, Kali Brom, Kali Iod, Kali Mur, Nat Brom, Niccolum Sulph, Phosphoricum AC, Sulphur Iod. LIQUID ORAL 20150521 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ANTIMONY TRISULFIDE; ARSENIC TRIBROMIDE; LYCOPERDON UTRIFORME FRUITING BODY; SYZYGIUM JAMBOS SEED; HYDROFLUORIC ACID; CALCIUM SULFIDE; POTASSIUM BROMIDE; POTASSIUM IODIDE; POTASSIUM CHLORIDE; SODIUM BROMIDE; NICKEL SULFATE HEXAHYDRATE; PHOSPHORIC ACID; SULFUR IODIDE 6; 30; 30; 14; 30; 30; 3; 3; 6; 4; 4; 30; 14 [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL N 20181231 66096-169_b25a7700-c12e-4b4c-9306-fe039f0eedc3 66096-169 HUMAN OTC DRUG OHM Acne Relief Calendula Officinalis, Chamomilla, Hamamelis Virginiana, Hepar Sulphuris Calcareum, Sulphur. GEL TOPICAL 20160222 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA CHAMOMILLA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; SULFUR 1; 1; 2; 6; 6 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g N 20181231 66096-170_b6fd8579-b087-42e8-ad91-3dca1e6b8a5c 66096-170 HUMAN OTC DRUG OHM FLU Anas barbariae, hepatis et cordis extractum, Influenzinum LIQUID ORAL 20150423 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; INFLUENZA A VIRUS; INFLUENZA B VIRUS 200; 9; 9 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 66096-171_f741ce64-45ad-4abb-b3b1-621a0c6a60ef 66096-171 HUMAN OTC DRUG OHM DRAINAGE LYMPHATIC TERRAIN Apis Mellifica, Aranea Diadema, Berberis Vulgaris, Equisetum Hyemale, Galium Aparine, Juglans Regia, Manganum Phosphoricum, Nicotinamidum, Nitricum Acidum, Sarsaparilla, Thuja Occidentalis, Urtica Urens LIQUID ORAL 20150423 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. APIS MELLIFERA; ARANEUS DIADEMATUS; BERBERIS VULGARIS ROOT BARK; EQUISETUM HYEMALE; GALIUM APARINE; JUGLANS REGIA WHOLE; MANGANESE PHOSPHATE, DIBASIC; NIACINAMIDE; NITRIC ACID; SMILAX REGELII ROOT; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 12; 9; 12; 7; 6; 6; 9; 9; 12; 9; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-172_6580d1db-c2b8-4140-8280-9dbbcb89217d 66096-172 HUMAN OTC DRUG OHM RESPIRATORY LOWER TERRAIN Aconitum, Aranea, Bryonia, Equisetum, Eupatorium Perf, Hydrastis, Juglans Reg, Kali Bic, Phosphorus, Sarsaparrilla, Sulphur LIQUID ORAL 20150423 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ACONITUM NAPELLUS; ARANEUS DIADEMATUS; BRYONIA ALBA ROOT; EQUISETUM HYEMALE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GOLDENSEAL; JUGLANS REGIA LEAF; POTASSIUM DICHROMATE; PHOSPHORUS; SMILAX REGELII ROOT; SULFUR 6; 9; 6; 7; 5; 7; 6; 12; 7; 9; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-173_0044b9dd-3cf5-4249-aec6-c31b3ca99866 66096-173 HUMAN OTC DRUG OHM Endocrine Masculine Terrain Agnus Castus, Caladium Seguinum, Damiana, Ginseng, Lycopodium Clavatum, Orchitinum, Sabal Serrulata, Selenium Metallicum, Zincum Metallicum. LIQUID ORAL 20150423 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CHASTE TREE; DIEFFENBACHIA SEGUINE; TURNERA DIFFUSA LEAFY TWIG; AMERICAN GINSENG; LYCOPODIUM CLAVATUM SPORE; SUS SCROFA TESTICLE; SAW PALMETTO; SELENIUM; ZINC 8; 8; 8; 7; 12; 7; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-174_fd142ee1-a2e7-4062-a93e-606746ec0b75 66096-174 HUMAN OTC DRUG Digestive Terrain Bryonia Alba, China Officinalis, Hydrastis Canadensis, Kali Bichromicum, Lycopodium Clavatum, Nux Moschata, Nux Vomica, Thuja Occidentalis. LIQUID ORAL 20110525 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. BRYONIA ALBA ROOT; CINCHONA OFFICINALIS BARK; GOLDENSEAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; NUTMEG; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG 7; 5; 7; 8; 8; 6; 7; 9 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL N 20181231 66096-175_80c1ab00-ff7f-447a-80e8-78e044f07704 66096-175 HUMAN OTC DRUG OHM Endocrine Feminine Terrain Cyclamen Europaeum, Erigeron Canadensis, Ignatia Amara, Lachesis Mutus, Moschus, Oophorinum, Pulsatilla, Sepia, Thlaspi Bursa-Pastoris, Viburnum Opulus. LIQUID ORAL 20120312 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CYCLAMEN PURPURASCENS TUBER; CONYZA CANADENSIS; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MOSCHUS MOSCHIFERUS WHOLE; SUS SCROFA OVARY; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; CAPSELLA BURSA-PASTORIS; VIBURNUM OPULUS BARK 7; 6; 12; 12; 12; 8; 12; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-176_40b93878-84ec-4e74-b6d8-03d6d204918d 66096-176 HUMAN OTC DRUG OHM HEPATIC TERRAIN Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, China Officinalis, Cynara Scolymus, Taraxacum Officinale, Veratrum Album LIQUID ORAL 20150423 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; TARAXACUM OFFICINALE; VERATRUM ALBUM ROOT 12; 6; 12; 7; 9; 7; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-177_88c916f1-9834-4a39-a0af-1fd79d61136d 66096-177 HUMAN OTC DRUG OHM Spastic Terrain Aconitum Napellus, Arnica Montana, Belladonna, Berberis Vulgaris, Bryonia Alba, Clematis Erecta, Colocynthis, Cuprum Aceticum, Hypericum Perforatum, Symphytum Officinale, Veratum Album. LIQUID ORAL 20110525 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CLEMATIS RECTA FLOWERING TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; CUPRIC ACETATE; HYPERICUM PERFORATUM; COMFREY ROOT; VERATRUM ALBUM ROOT 6; 5; 5; 4; 4; 4; 4; 5; 5; 7; 4 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL N 20181231 66096-178_e6ec1db0-2470-496c-b97b-cc78c030e3b6 66096-178 HUMAN OTC DRUG OHM OSTEOARTICULAR TERRAIN Arnica Montana, Calcarea Phosphorica, Causticum, China Officinalis, Colchicum Autumnale, Dulcamara, Ledum Palustre, Rhus Toxicodendron, Symphytum Officinale LIQUID ORAL 20150423 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARNICA MONTANA; TRIBASIC CALCIUM PHOSPHATE; CAUSTICUM; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; COMFREY ROOT 4; 12; 12; 12; 12; 6; 7; 12; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-179_75233c82-29d1-4ddf-98c6-9f417bce6ea8 66096-179 HUMAN OTC DRUG OHM CIRCULATORY TERRAIN Baryta Iodata, Cactus Grandiflorus, Carbo Vegetabilis, Crataegus Oxyacantha, Curare, Kali Carbonicum, Kalmia Latifolia, Melilotus Officinale, Naja Tripudians, Secale Cornutum, Solanum Nigrum, Spigelia Anthelmia LIQUID ORAL 20150423 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. BARIUM IODIDE; SELENICEREUS GRANDIFLORUS STEM; ACTIVATED CHARCOAL; HAWTHORN LEAF WITH FLOWER; TUBOCURARINE CHLORIDE; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; MELILOTUS OFFICINALIS TOP; NAJA NAJA VENOM; CLAVICEPS PURPUREA SCLEROTIUM; SOLANUM NIGRUM TOP; SPIGELIA ANTHELMIA 12; 6; 12; 6; 12; 7; 6; 6; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-180_0ed2455a-b135-4cea-b4d0-26d34177c356 66096-180 HUMAN OTC DRUG OHM Nervous Terrain Ambra Grisea, Anacardium Orientale, Arnica Montana, Aurum Metallicum, Avena Sativa, China Officinalis, Gelsemium Sempervirens, Ignatia Amara, Kali Phosphoricum, Magnesia Phosphorica, Manganum Phosphoricum, Moschus, Phosphoricum Acidum, Rhus Toxicodendron, Selenium Metallicum. LIQUID ORAL 20150423 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; ARNICA MONTANA; GOLD; AVENA SATIVA FLOWERING TOP; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE PHOSPHATE, DIBASIC; MOSCHUS MOSCHIFERUS WHOLE; PHOSPHORIC ACID; TOXICODENDRON PUBESCENS LEAF; SELENIUM 12; 8; 8; 12; 12; 7; 7; 12; 8; 10; 10; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-181_2a3e9e5b-e603-4513-898e-bbca7bd1532b 66096-181 HUMAN OTC DRUG OHM RENAL TERRAIN Apis Mellifica, Aranea Diadema, Berberis Vulgaris, Cantharis, Equisetum Hyemale, Hydrastis Canadensis, Juglans Regia, Kali Bichromicum, Mercurius Solubilis, Sarsaparilla, Solidago Virgaurea LIQUID ORAL 20150423 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. APIS MELLIFERA; ARANEUS DIADEMATUS; BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; EQUISETUM HYEMALE; GOLDENSEAL; JUGLANS REGIA LEAF; POTASSIUM DICHROMATE; MERCURIUS SOLUBILIS; SMILAX REGELII ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 8; 12; 7; 7; 6; 7; 10; 12; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-182_47661ca5-9dcd-4940-b71e-2a3cca8d43e9 66096-182 HUMAN OTC DRUG OHM PANCREATIC TERRAIN Carbo Vegetabilis, Ceanothus Americanus, Gallium Aparine, Leptandra Virginica, Mandragora Officinarum, Momordica Balsamina, Quassia Amara LIQUID ORAL 20150423 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ACTIVATED CHARCOAL; CEANOTHUS AMERICANUS LEAF; GALIUM APARINE; VERONICASTRUM VIRGINICUM ROOT; MANDRAGORA OFFICINARUM ROOT; MOMORDICA BALSAMINA IMMATURE FRUIT; QUASSIA AMARA WOOD 12; 10; 5; 5; 10; 8; 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-183_6b9ed159-63b5-44ca-857b-029633f4b469 66096-183 HUMAN OTC DRUG Respiratory Upper Terrain Euphorbium Officinarum, Histaminium Hydrochloricum, Hydrastis Canadensis, Kali Bichromicum, Luffa Operculata, Pulsatilla. LIQUID ORAL 20110525 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. EUPHORBIA RESINIFERA RESIN; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; LUFFA OPERCULATA FRUIT; PULSATILLA VULGARIS 5; 12; 6; 8; 8; 5 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL N 20181231 66096-184_bf04af27-897c-4cdc-abce-f2bc4565922d 66096-184 HUMAN OTC DRUG OHM Dermatological Terrain Calcarea Carbonica, Calcarea Fluorica, Carduus Marianus, China Officinalis, Cynara Scolymus, Galium Aparine, Graphites, Hepar Sulphuris Calcareum, Manganum Phosphoricum, Nicotinamidum, Oleander, Taraxacum Officinale, Thuja Occidentalis. LIQUID ORAL 20150413 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; MILK THISTLE; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; GALIUM APARINE; GRAPHITE; CALCIUM SULFIDE; MANGANESE PHOSPHATE, DIBASIC; NIACINAMIDE; NERIUM OLEANDER LEAF; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 5; 5; 8; 8; 12; 12; 8; 7; 6; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-185_ca23edf3-6b27-4743-bfae-55fc1d0aebf2 66096-185 HUMAN OTC DRUG OHM Tonic Metabolic Terrain Baryta Carbonica, Galium Aparine, Kali Phosphoricum, Manganum Phosphoricum, Melilotus Officinalis, Nicotinamidum, Strophanthus Hispidus, Thyroidinum, Viscum Album. LIQUID ORAL 20110525 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. BARIUM CARBONATE; GALIUM APARINE; POTASSIUM PHOSPHATE, DIBASIC; MANGANESE PHOSPHATE, DIBASIC; MELILOTUS OFFICINALIS TOP; NIACINAMIDE; STROPHANTHUS HISPIDUS SEED; THYROID, UNSPECIFIED; VISCUM ALBUM FRUITING TOP 12; 7; 7; 7; 9; 8; 8; 12; 6 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL N 20181231 66096-186_03b6f067-2073-4b55-82eb-8f25020cee90 66096-186 HUMAN OTC DRUG OHM IMMUNOLOGICAL ACUTE TERRAIN Aconitum Napellus, Aranea Diadema, Arnica Montana, Asclepias Vincetoxicum, Baptisia Tinctoria, Bryonia Alba, Echinacea Angustifolia, Equisetum Hyemale, Eupatorium Perforliatum, Gelsemium Sempervirens, Hepar Sulphuris Calcareum, Juglans Regia, Phytolacca Decandra, Sanguinaria Canadensis, Sarsaparilla, Sulphur, Zincum Metallicum LIQUID ORAL 20150423 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ACONITUM NAPELLUS; ARANEUS DIADEMATUS; ARNICA MONTANA; CYNANCHUM VINCETOXICUM ROOT; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; EQUISETUM HYEMALE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; JUGLANS REGIA LEAF; PHYTOLACCA AMERICANA ROOT; SANGUINARIA CANADENSIS ROOT; SMILAX REGELII ROOT; SULFUR; ZINC 7; 9; 6; 12; 8; 10; 6; 7; 10; 8; 12; 6; 10; 8; 9; 10; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66096-187_00989097-6c2d-4137-aba3-0858333cc6b6 66096-187 HUMAN OTC DRUG Immunological Chronic Terrain Aurum Metallicum, Conium Maculatum, Galium Aparine, Hydrastis Canadensis, Nitricum Acidum, Thuja Occidentalis, Urtica Urens, Viscum Album. LIQUID ORAL 20110525 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. GOLD; CONIUM MACULATUM FLOWERING TOP; GALIUM APARINE; GOLDENSEAL; NITRIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS; VISCUM ALBUM FRUITING TOP 12; 6; 6; 6; 12; 6; 6; 6 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL N 20181231 66096-188_744064da-69bd-49ec-b692-6c7a8e73a43d 66096-188 HUMAN OTC DRUG Inflammatory Terrain Aconitum Napellus, Apis Mellifica, Arnica Montana, Belladonna, Bellis Perennis, Calendula Officinalis, Chamomilla, Echinacea Angustifolia, Echinacea Purpurea, Hamamelis Virginiana, Hypericum Perforatum, Millefolium, Ledum Palustre, Ruta Graveolens, Symphytum Officinale. LIQUID ORAL 20110525 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 6; 12; 5; 5; 5; 5; 6; 5; 5; 5; 5; 6; 7; 7; 7 [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL; [hp_X]/2.2mL N 20181231 66096-191_75c5ff60-8db5-455f-a9f3-b7f15b35683a 66096-191 HUMAN OTC DRUG Ohm Cholesterol Aid Cholesterinum, Fel Tauri, Guatteria Guameri. LIQUID ORAL 20170110 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CHOLESTEROL; BOS TAURUS BILE; MALMEA DEPRESSA BARK 13; 3; 5 [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-192_cc41f163-7fc7-4d80-ad1e-6b419eae153f 66096-192 HUMAN OTC DRUG Eczema Relief Arsenicum Iodatum, Kali Bromatum, Kali Muriaticum, Natrum Bromatum, Niccolum Sulphuricum, Sulphur Iodatum, Viola Tricolor, Zincum Bromatum. LIQUID ORAL 20150522 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARSENIC TRIIODIDE; POTASSIUM BROMIDE; POTASSIUM CHLORIDE; SODIUM BROMIDE; NICKEL SULFATE HEXAHYDRATE; SULFUR IODIDE; VIOLA TRICOLOR; ZINC BROMIDE 8; 4; 4; 4; 5; 14; 12; 6 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-341_03dba0d4-1b51-4682-a899-f89c33ff1278 66096-341 HUMAN PRESCRIPTION DRUG OHM Venous Aid Aesculus Hippocastanum, Arnica Montana, Calendula Officinalis, Echinacea Purpurea, Hamamelis Virginiana, Paeonia Officinalis, Ratanhia. CREAM TOPICAL 20150624 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. HORSE CHESTNUT; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT 1; 1; 1; 1; 3; 1; 3 [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g N 20181231 66096-395_a8a20db5-a59b-46db-8c42-b1a389acc1d6 66096-395 HUMAN OTC DRUG Vida Hair Nourish Arnica montana, Kali phosphoricum, Selenium Metallicum, Silicea. SPRAY ORAL 20170102 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARNICA MONTANA; DIBASIC POTASSIUM PHOSPHATE; SELENIUM; SILICON DIOXIDE 6; 6; 6; 6 [hp_C]/30mL; [hp_C]/30mL; [hp_Q]/30mL; [hp_C]/30mL N 20181231 66096-397_462c518d-679d-4740-8b5d-9b3fc588faf7 66096-397 HUMAN OTC DRUG Vida Hair Arnica Montana, Rosmarinus Off. LOTION TOPICAL 20170102 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARNICA MONTANA; ROSMARINUS OFFICINALIS FLOWERING TOP 1; 2 [hp_X]/120mL; [hp_X]/120mL N 20181231 66096-527_cce7ff3d-c3db-415c-9b4e-cf51e0ee6d59 66096-527 HUMAN OTC DRUG OHM Sinus Nasal Aralia Rac, Euphorbium, Galphimia, Hepar Sulph Calc, Histaminum, Hydrastis, Kali Bic, Kali Iod, Luffa, Pulsatilla, Teucrium Mar. SPRAY NASAL 20170123 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARALIA RACEMOSA ROOT; EUPHORBIA RESINIFERA RESIN; GALPHIMIA GLAUCA FLOWERING TOP; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LUFFA OPERCULATA FRUIT; ANEMONE PULSATILLA; TEUCRIUM MARUM 6; 6; 6; 12; 12; 12; 12; 4; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 66096-636_6f0baa4f-9378-4810-a318-588cdc888f23 66096-636 HUMAN OTC DRUG Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic Combination Calcarea Fluorica, Calcarea Phosphorica, Silicea PELLET ORAL 20151021 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; SILICON DIOXIDE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 66096-663_6ceffa5b-756b-4c34-84c6-f160b09389fb 66096-663 HUMAN PRESCRIPTION DRUG OHM Calendula Balancing Calendula, Calc Phos, Kali Iod, Silicea, Arnica, Chamomilla, Urtica Ur. SHAMPOO TOPICAL 20160223 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CALENDULA OFFICINALIS FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; POTASSIUM IODIDE; SILICON DIOXIDE; ARNICA MONTANA; MATRICARIA CHAMOMILLA; URTICA URENS 1; 6; 3; 6; 1; 1; 1 [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 66096-669_0d34ca09-fa3b-4602-ad66-1a1d8ff0f15b 66096-669 HUMAN OTC DRUG OHM Allergy Animal Mix Cat Hair, Cattle, Dog, Guinea Pig, Hamster, Hog, Mouse, Rabbit Hair and Epithelia, Chicken, Duck, Goose Feathers, Horse Hair and Dander, Histaminum. SPRAY ORAL 20130313 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. FELIS CATUS HAIR; BOS TAURUS HAIR; CANIS LUPUS FAMILIARIS HAIR; CAVIA PORCELLUS HAIR; MESOCRICETUS AURATUS SKIN; SUS SCROFA HAIR; MUS MUSCULUS HAIR; ORYCTOLAGUS CUNICULUS HAIR; ORYCTOLAGUS CUNICULUS SKIN; GALLUS GALLUS FEATHER; ANAS PLATYRHYNCHOS FEATHER; ANSER ANSER FEATHER; EQUUS CABALLUS HAIR; EQUUS CABALLUS DANDER; HISTAMINE DIHYDROCHLORIDE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 60 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; 1/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-670_7909b2e3-cd37-41b6-bf7d-17c70cf66193 66096-670 HUMAN OTC DRUG OHM Allergy Mold Mix Alternaria Alt, Aspergillus Fum, Aspergillus Nig, Boletus Sat, Botrytis Cin, Candida Alb, Cladosporium Met, Fusarium Oxy, Helminthosporium, Murcor Mue, Pullularia Pul, Rhizopus Nig, Ustaligo, Histaminum. LIQUID ORAL 20151029 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; BOLETUS SATANAS FRUITING BODY; BOTRYTIS CINEREA; CANDIDA ALBICANS; PASSALORA FULVA; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; USTILAGO MAYDIS; HISTAMINE DIHYDROCHLORIDE 14; 14; 14; 14; 14; 14; 14; 14; 14; 14; 14; 14; 60 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-671_de965309-a5e3-4234-9d6b-f9ea8fa2cea9 66096-671 HUMAN OTC DRUG OHM Allergy Grass, Weed, Tree Mix Bermuda, Birch Mix, Brome, Carduus Marianus, Chelidonium Majus, Common Mugwort, English Plantain, Goldenrod, Hydrastis Canadensis, Histam, Johnson, Kentucky, Maple Mix, Nasturtium Aqua, Oak Mix, Orchard, Pigweed Mix, Pine Mix, Ragweed Mix, Red Cedar, Red Mulb, Scrophularia Nod, Sheep Sorrel, Soildago Virg, Sweet Vernal, Taraxacum Offi, Timothy, White Poplar. SPRAY ORAL 20130313 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CYNODON DACTYLON; BETULA PENDULA WHOLE; BROMUS SECALINUS TOP; MILK THISTLE; CHELIDONIUM MAJUS; ARTEMISIA VULGARIS POLLEN; PLANTAGO LANCEOLATA POLLEN; SOLIDAGO VIRGAUREA POLLEN; GOLDENSEAL; HISTAMINE DIHYDROCHLORIDE; SORGHUM HALEPENSE POLLEN; POA PRATENSIS POLLEN; ACER PSEUDOPLATANUS POLLEN; NASTURTIUM OFFICINALE; QUERCUS SPP. WHOLE; DACTYLIS GLOMERATA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; PINUS MASSONIANA POLLEN; AMBROSIA ARTEMISIIFOLIA; JUNIPERUS VIRGINIANA POLLEN; MORUS RUBRA POLLEN; SCROPHULARIA NODOSA; RUMEX ACETOSELLA POLLEN; SOLIDAGO VIRGAUREA FLOWERING TOP; ANTHOXANTHUM ODORATUM POLLEN; TARAXACUM OFFICINALE POLLEN; PHLEUM PRATENSE POLLEN; POPULUS ALBA POLLEN 6; 6; 6; 3; 3; 6; 6; 6; 5; 60; 6; 6; 6; 3; 6; 6; 6; 6; 6; 6; 6; 3; 6; 3; 6; 3; 6; 6 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-672_a46a170a-e456-4ad4-9e49-c5a3d8fe81b4 66096-672 HUMAN OTC DRUG Vida Hair Oil Arnica Montana. SPRAY TOPICAL 20170102 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARNICA MONTANA 1 [hp_X]/60mL N 20181231 66096-678_4d0c940b-588f-43ee-963c-e85814d2af72 66096-678 HUMAN OTC DRUG Rejuvenate 2000 Maximum Strength Formula For Men rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 66096-681_6ecb25d2-ff84-404f-819a-a72fda88d14a 66096-681 HUMAN OTC DRUG Miranda Castros Healing Gel for Bites and Stings Calendula Officinalis, Caladium Seguinum, Ledum Palustre, Natrum Muriaticum, Plantago Major, Staphysagria, Urtica Urens. GEL TOPICAL 20150521 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CALENDULA OFFICINALIS FLOWERING TOP; DIEFFENBACHIA SEGUINE; RHODODENDRON TOMENTOSUM LEAFY TWIG; SODIUM CHLORIDE; PLANTAGO MAJOR; DELPHINIUM STAPHISAGRIA SEED; URTICA URENS 1; 12; 6; 3; 1; 6; 1 [hp_X]/28.3g; [hp_X]/28.3g; [hp_X]/28.3g; [hp_X]/28.3g; [hp_X]/28.3g; [hp_X]/28.3g; [hp_X]/28.3g N 20181231 66096-682_e0053003-1528-42c0-83f4-80af96ea809a 66096-682 HUMAN OTC DRUG Rejuvenate 2000 Maximum Strength Formula For Women rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 66096-683_d4dbd302-7b8d-4d5f-a0c1-82cfccd25bf2 66096-683 HUMAN OTC DRUG Rejuvenate 2000 Power Up Formula For Men rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 66096-684_96a1a4f5-c98e-48b5-a8b8-a5d3d66ba9cd 66096-684 HUMAN OTC DRUG Rejuvenate 2000 PM Formula For Men rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 66096-685_77dce39e-524d-422b-b355-e64d9fcdf176 66096-685 HUMAN OTC DRUG Rejuvenate 2000 PM Formula For Women rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 66096-686_83a794d4-9d73-4769-83e1-50efdb889012 66096-686 HUMAN OTC DRUG Rejuvenate 2000 Athletic Formula For Women rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Oophorinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA OVARY; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 66096-687_c7f29d1b-48fb-496b-b730-c7bc15d3746a 66096-687 HUMAN OTC DRUG Rejuvenate 2000 Athletic Formula For Men rSomatotropin, rIGF-I, rIGF-II, RNA, DNA,Glandula Suprarenalis Suis, Hepar Suis, Pituitarium Posterium, Thymus, Thyroidinum, Placenta Totalis Suis, Orchitinum, Abrotanum, Anacard Or, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Phos, Ferrum Met, Fucus, Hekla, Hellebor Nig, Ignatia, Lycopodium, Nicotinamidium, Secale, Silicea, Cobaltum Met, Lithium Carb, Mag Phos, Mang Acet, Kali Phos, Selenium Met, Zinc Met. SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. SOMATROPIN; DALOTUZUMAB; SACCHAROMYCES CEREVISIAE RNA; HERRING SPERM DNA; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYMUS; THYROID, UNSPECIFIED; SUS SCROFA PLACENTA; SUS SCROFA TESTICLE; ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; COBALT; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MANGANESE ACETATE TETRAHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; SELENIUM; ZINC 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 12; 12; 12; 12; 12; 12; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 66096-692_d357e6dc-9df9-4ecd-9b84-a931ab15a723 66096-692 HUMAN OTC DRUG OHM Muscle and Joint Pain Relief Arnica, Aconitum Nap, Arnica, Belladonna, Bellis, Calc Fluor, Calc Phos, Calendula, Echinacea, Hamamelis, Hypericum, Kali Mur, Ledum, Mag Phos, Rhus Tox, Ruta, Symphytum. CREAM TOPICAL 20110222 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARNICA MONTANA FLOWER; ACONITUM NAPELLUS; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; POTASSIUM CHLORIDE; RHODODENDRON TOMENTOSUM LEAFY TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 1; 3; 3; 3; 4; 4; 1; 1; 200; 1; 3; 2; 3; 3; 1; 6 [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_C]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g N 20181231 66096-693_6251c91d-c5fa-431b-b2fb-c09c2222beea 66096-693 HUMAN OTC DRUG OHM Skin Healing Cream Calendula Officinalis, Stellaria Media, Calcarea Sulphurica, Chamomilla, Echinacea Angustifolia, Silicea, Symphytum Officinale, Thiosinamium, Hamamelis Virginiana. CREAM TOPICAL 20161115 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CALENDULA OFFICINALIS FLOWERING TOP; STELLARIA MEDIA; CALCIUM SULFATE ANHYDROUS; MATRICARIA RECUTITA; ECHINACEA ANGUSTIFOLIA; SILICON DIOXIDE; COMFREY ROOT; ALLYLTHIOUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1; 1; 3; 1; 1; 3; 6; 3; 1 [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g N 20181231 66096-695_c0d61621-3ee2-4ada-b1f8-04a7f356a33d 66096-695 HUMAN OTC DRUG OHM Drainage Lymphatic Aesculus Hipp, Apis Mel, Aranea, Baryta Carb, Equisetum Hyem, Fucus, Fumaria, Juglans Cin, Kali Iod, Kali Mur, Myosotis, Nasturtium, Nat Sulphuricum, Phytolacca, Sarsaparilla, Scrophulara, Secale, Teucrium Scor, Thyroidinum, Vipera. GEL TOPICAL 20141216 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. HORSE CHESTNUT; APIS MELLIFERA; ARANEUS DIADEMATUS; BARIUM CARBONATE; EQUISETUM HYEMALE; FUCUS VESICULOSUS; FUMARIA OFFICINALIS FLOWERING TOP; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM IODIDE; POTASSIUM CHLORIDE; MYOSOTIS ARVENSIS; NASTURTIUM OFFICINALE; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; SMILAX ORNATA ROOT; SCROPHULARIA NODOSA; CLAVICEPS PURPUREA SCLEROTIUM; TEUCRIUM SCORODONIA FLOWERING TOP; THYROID, UNSPECIFIED; VIPERA BERUS VENOM 4; 4; 14; 14; 3; 3; 2; 2; 2; 2; 2; 2; 2; 2; 2; 3; 6; 2; 10; 6 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g N 20181231 66096-699_e01cb206-8ccb-49b1-bf7e-d9541c752121 66096-699 HUMAN OTC DRUG OHM Skin Growths Thuja Occ., Baptisia Tinctoria, Calendula Officinalis, Hydrastis Canadensis. GEL TOPICAL 20170823 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. THUJA OCCIDENTALIS LEAFY TWIG; BAPTISIA TINCTORIA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; GOLDENSEAL 1; 1; 1; 5 [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g; [hp_X]/56.7g N 20181231 66096-701_e70cd1ef-6e07-47d9-a5d3-9754bf65e7d7 66096-701 HUMAN OTC DRUG OHM Muscle and Joint Pain Relief Gel Arnica, Aconitum Nap, Arnica, Belladonna, Bellis, Calc Fluor, Calc Phos, Calendula, Echinacea Purp, Hamamelis, Hypericum, Kali Mur, Ledum, Mag Phos, Rhus Tox, Ruta, Symphytum. GEL TOPICAL 20170913 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARNICA MONTANA; ACONITUM NAPELLUS; ATROPA BELLADONNA; BELLIS PERENNIS; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; POTASSIUM CHLORIDE; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT 1; 3; 3; 3; 4; 4; 1; 1; 200; 1; 3; 2; 3; 3; 1; 6 [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_C]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g; [hp_X]/96.5g N 20181231 66096-704_53d0b6cb-3021-4c82-a616-f63cc3d8d438 66096-704 HUMAN OTC DRUG OHM Immune Booster Aethusa Cynapium, Avena Sativa, Calcarea Phosphorica, Cypripedium Pubescens, Hyosciamus Niger, Scutellaria Laterifolia, Tarentula Hispanica. TABLET, ORALLY DISINTEGRATING ORAL 20150514 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. AETHUSA CYNAPIUM; AVENA SATIVA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; HYOSCYAMUS NIGER LEAF; SCUTELLARIA LATERIFLORA; LYCOSA TARANTULA 30; 4; 4; 6; 6; 4; 30 [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1 N 20181231 66096-705_404a6759-3629-4bec-b3d4-1a0b488159ea 66096-705 HUMAN OTC DRUG OHM Motion Sickness Aid Cocculus Indicus, Conium Maculatum, Petroleum, Tabacum, Tellurium Metallicum, Theridion. TABLET, CHEWABLE ORAL 20150428 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP; KEROSENE; TOBACCO LEAF; TELLURIUM; THERIDION CURASSAVICUM 3; 3; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 66096-706_f0b972f4-0f28-49c1-b34b-688499bdaa5f 66096-706 HUMAN OTC DRUG OHM Mucus Relief Antimonium Crudum, Antimonium Tartaricum, Chelidonium Majus, Ferrum Phosphoricum, Kali Carboonicum, Kali muriaticum, Kali Sulphuricum, Marrubium Vulgare. TABLET, CHEWABLE ORAL 20150514 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ANTIMONY TRISULFIDE; ANTIMONY POTASSIUM TARTRATE; CHELIDONIUM MAJUS; FERROSOFERRIC PHOSPHATE; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; MARRUBIUM VULGARE 6; 6; 6; 6; 12; 30; 6; 6; 9 [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 N 20181231 66096-707_2dc84b73-f406-4273-a446-f78ddbd9d532 66096-707 HUMAN OTC DRUG OHM Sting Relief and Insect Repellent Apis Mel, Arnica, Belladonna, Caladium, Calendula, Graphites, Ledum, Pulsatilla, Rhus Tox, Staphysagria. SPRAY TOPICAL 20150623 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; DIEFFENBACHIA SEGUINE; CALENDULA ARVENSIS WHOLE; GRAPHITE; RHODODENDRON TOMENTOSUM LEAFY TWIG; ANEMONE PULSATILLA; TOXICODENDRON PUBESCENS LEAF; DELPHINIUM STAPHISAGRIA SEED 6; 1; 6; 14; 2; 6; 6; 6; 6; 6 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL N 20181231 66096-708_9e03ef0a-c2f5-4430-98df-2334478c078f 66096-708 HUMAN OTC DRUG Kids Cough Relief Syrup Antimonium Sulphuratum Aureum, Antimonium Tartaricum, Bryonia Alba, Drosera Rotundifolia, Ipecacuanha, Kali Muriaticum, Rumex Crispus, Senega Officinalis, Spongia Tosta. LIQUID ORAL 20150820 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ANTIMONY PENTASULFIDE; ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC; POTASSIUM CHLORIDE; RUMEX CRISPUS ROOT; POLYGALA SENEGA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED 12; 6; 6; 6; 6; 6; 6; 6; 6 [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL N 20181231 66096-709_8a05d30e-718d-489f-b083-c7851ec33ef0 66096-709 HUMAN OTC DRUG Cough Relief Syrup Althaea, Antimon Sulph, Antimon Tart, Bryonia, Cetraria, Chamomilla, Drosera, Echinacea Ang, Ipecac, Kali Mur, Plantago, Rumex Crisp, Senega, Spongia, Thymus, Trifolium Prat, Urtica Di, Verbascum. LIQUID ORAL 20150818 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ALTHAEA OFFICINALIS ROOT; ANTIMONY PENTASULFIDE; ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; MATRICARIA RECUTITA; DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA; IPECAC; POTASSIUM CHLORIDE; PLANTAGO LANCEOLATA POLLEN; RUMEX CRISPUS ROOT; POLYGALA SENEGA ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA THYMUS; TRIFOLIUM PRATENSE FLOWER; URTICA DIOICA; VERBASCUM THAPSUS 1; 12; 6; 6; 1; 1; 6; 1; 6; 6; 1; 6; 6; 6; 1; 1; 1; 1 [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL N 20181231 66096-710_a84780a4-8756-4783-8aaf-a40f19521b3a 66096-710 HUMAN OTC DRUG Allergy Relief Allium Cepa, Apis Mellifica, Aralia Racemosa, Blatta Orientalis, Bovista, Carduus Marianus, Chelidonium Majus, Euphrasia Officinalas, Galphimia Glauca, Hedera Helix, Hydrastis Canadensis, Luffa Operculata, Nasturtium Aquaticum, Okoubaka, Sabadilla, Scrophularia Nodosa, Solidago Virgaurea, Taraxacum Officinale. LIQUID ORAL 20170602 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ONION; APIS MELLIFERA; ARALIA RACEMOSA ROOT; BLATTA ORIENTALIS; LYCOPERDON UTRIFORME FRUITING BODY; MILK THISTLE; CHELIDONIUM MAJUS; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; GOLDENSEAL; LUFFA OPERCULATA FRUIT; NASTURTIUM OFFICINALE; OKOUBAKA AUBREVILLEI BARK; SCHOENOCAULON OFFICINALE SEED; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE 5; 5; 5; 12; 12; 3; 3; 8; 5; 5; 5; 5; 3; 5; 5; 3; 5; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-711_6fc84a88-0ab6-4725-aa68-379e37d825c8 66096-711 HUMAN PRESCRIPTION DRUG OHM Tonic Syrup Alfalfa, Aralia Quin (Ginseng), Avena, Calc Phos, Cinchona, Ferrum Phos, Hydrastis, Kali Iod, Kali Mur, Kali Phos, Mag Phos, Nat Phos, Nux Vom, Phosphoricum Ac. LIQUID ORAL 20150915 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ALFALFA; AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; CINCHONA BARK; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; POTASSIUM IODIDE; POTASSIUM CHLORIDE; DIBASIC POTASSIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID 1; 1; 1; 6; 2; 6; 5; 6; 6; 6; 6; 6; 6; 14 [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL; [hp_X]/148mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 66096-712_59ca1df4-02be-4f6c-8eaa-0f57a1da2458 66096-712 HUMAN OTC DRUG Joette Calabrese Survivalist Kit Abrot Acon Agn Ail Ambr Ambro Am-C Ant-C Apis Arn Ars Aur-A Aur Bapt Bar-C Bell BB Both Bov Brom Cadm-S Calad Calc Camph Carb-Ac Card-M Cean Chel Chinin-A Cina Chin Cic Cob Colch Con Crot-H Crot-T Cupr Dulc Elaps Eup-Per Fl-Ac Galph Graph Gunp Ham Hekla Hell Hep Hydr-Ac Hyos Hyper Kali-Br Kali-C Kali-I Lath Laur Led Lob Merc-Cy Merc Mez Mosch Mur-Ac Naja Nat-C Nit-Ac Nux-M Pyrog Ph-Ac Pic-Ac Plb Rhus-T Ruta Samb Sang Sarr Sep Stram Sul-Ac Tab Terent Ter Teucr Verat Verat-V Vip PELLET ORAL 20151026 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARTEMISIA ABROTANUM FLOWERING TOP; ACONITUM NAPELLUS; AETHUSA CYNAPIUM; CHASTE TREE; AILANTHUS ALTISSIMA FLOWERING TWIG; AMBERGRIS; AMBROSIA ARTEMISIIFOLIA POLLEN; AMMONIUM CARBONATE; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; GOLD; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; ATROPA BELLADONNA; BORRELIA BURGDORFERI; BOTHROPS ATROX VENOM; LYCOPERDON UTRIFORME FRUITING BODY; BROMINE; CADMIUM SULFATE; DIEFFENBACHIA SEGUINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAMPHOR (NATURAL); PHENOL; MILK THISTLE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; QUININE SULFATE; ARTEMISIA CINA PRE-FLOWERING TOP; CINCHONA OFFICINALIS BARK; CICUTA VIROSA ROOT; COBALT; COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; CROTALUS HORRIDUS HORRIDUS VENOM; CROTON TIGLIUM SEED; COPPER; SOLANUM DULCAMARA TOP; MICRURUS CORALLINUS VENOM; EUPATORIUM PERFOLIATUM FLOWERING TOP; HYDROFLUORIC ACID; GALPHIMIA GLAUCA FLOWERING TOP; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HEKLA LAVA; HELLEBORUS NIGER ROOT; CALCIUM SULFIDE; HYDROGEN CYANIDE; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; POTASSIUM BROMIDE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LATHYRUS SATIVAS SEED; PRUNUS LAUROCERASUS LEAF; LEDUM PALUSTRE TWIG; LOBELIA INFLATA; MERCURIC CYANIDE; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; MOSCHUS MOSCHIFERUS WHOLE; HYDROCHLORIC ACID; NAJA NAJA VENOM; SODIUM CARBONATE; NITRIC ACID; NUTMEG; RANCID BEEF; PHOSPHORIC ACID; PICRIC ACID; LEAD; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SAMBUCUS NIGRA FLOWERING TOP; SANGUINARIA CANADENSIS ROOT; SARRACENIA PURPUREA; CLAVICEPS PURPUREA SCLEROTIUM; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; SULFURIC ACID; TOBACCO LEAF; LYCOSA TARANTULA; TURPENTINE OIL; TEUCRIUM MARUM; VERATRUM ALBUM ROOT; VERATRUM VIRIDE ROOT; VIPERA BERUS VENOM 6; 1; 200; 200; 30; 30; 30; 30; 6; 1; 3; 3; 200; 200; 30; 3; 200; 30; 30; 30; 30; 30; 1; 200; 6; 30; 30; 6; 3; 3; 3; 30; 30; 30; 3; 6; 30; 6; 30; 30; 200; 30; 30; 200; 200; 30; 30; 6; 30; 6; 1; 30; 200; 6; 30; 30; 1; 30; 200; 6; 200; 30; 30; 30; 30; 30; 30; 200; 6; 200; 30; 1; 6; 30; 200; 30; 6; 6; 30; 30; 30; 30; 6; 200; 200; 30; 30 [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_M]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 66096-713_50f96c9f-e6f2-4b15-8e3b-831b2ea215c8 66096-713 HUMAN OTC DRUG Anxiety Stress Relief Arg Nit, Aur Met, Avena, Gelsemium, Hyoscyamus, Ignatia, Moschus, Nat Mur, Passiflora, Stannum Met, Valeriana. LIQUID ORAL 20160301 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; MOSCHUS MOSCHIFERUS WHOLE; SODIUM CHLORIDE; PASSIFLORA INCARNATA TOP; TIN; VALERIAN 8; 13; 2; 13; 13; 13; 13; 13; 2; 13; 2 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-714_5147d66a-d39d-4da9-ba40-cc61c886e7cb 66096-714 HUMAN OTC DRUG Vida Arnica Montana, Betula, Rosmarinus Off. SHAMPOO TOPICAL 20170102 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ARNICA MONTANA; ALNUS GLUTINOSA LEAF; ROSMARINUS OFFICINALIS FLOWERING TOP 1; 1; 1 [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL N 20181231 66096-715_5904ff35-00e9-434f-9b4c-c23bd8321bd1 66096-715 HUMAN OTC DRUG Rhus Tox 4X, 8X, 12X Rhus Toxicodendron. LIQUID ORAL 20170306 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. TOXICODENDRON PUBESCENS LEAF 4 [hp_X]/30mL N 20181231 66096-716_0c3900b3-24e3-4bfe-92d3-3ef88eca117a 66096-716 HUMAN OTC DRUG Hydrate II Berberis Aquifolium, Beta Vulgaris, Boldo, Chelidonium Majus, Hordeum Vulgare, Iris Versicolor, Rosmarinus Officinale, Carduus Marianus, Taraxacum Officinale, Avena Sativa, Eleutherococcus Senticosus, Xanthoxylum Fraxineum, Equisetum Hyemale, Hypericum Perforatum, Ulmus Fulva, Gettysburg Aqua, Glycyrrhiza Glabra, Wildbad Aqua, Carlsbad Aqua, ATP, Hydrogen, Natrum Muriaticum, Oxygen, Silicea, Wiesbaden Aqua. LIQUID ORAL 20170314 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. BERBERIS AQUIFOLIUM ROOT BARK; BETA VULGARIS; PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS; BARLEY; IRIS VERSICOLOR ROOT; ROSMARINUS OFFICINALIS FLOWERING TOP; TARAXACUM OFFICINALE; AVENA SATIVA FLOWERING TOP; ELEUTHERO; ZANTHOXYLUM AMERICANUM BARK; EQUISETUM HYEMALE; HYPERICUM PERFORATUM; ULMUS RUBRA BARK; GLYCYRRHIZA GLABRA; ADENOSINE TRIPHOSPHATE; HYDROGEN; SODIUM CHLORIDE; OXYGEN; SILICON DIOXIDE 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 30; 30; 30; 30; 30 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL N 20181231 66096-722_7f777d63-e5b6-430a-94b6-534874d5401d 66096-722 HUMAN OTC DRUG Lyme Disease Support 1 Alumen, Calcarea carbonica, DNA, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali carbonicum, Kali muriaticum, Kali sulphuricum, Magnesia phosphorica, Natrum muriaticum, Natrum phosphoricum, RNA, Silicea. LIQUID ORAL 20171120 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. POTASSIUM ALUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; HERRING SPERM DNA; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM CARBONATE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE 12; 6; 4; 6; 6; 6; 6; 6; 6; 6; 6; 4; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL N 20181231 66096-723_6e3bf4ec-29eb-4f97-9638-f679c56afc67 66096-723 HUMAN OTC DRUG Lyme Disease Support 2 Argentum nitricum, Astragalus menziesii, Calcarea sulphurica, Cuprum arsenicosum, DNA, Ferrum phosphoricum, Kali muriaticum, Kali sulphuricum, Ledum palustre, Magnesia phosphorica, RNA, Silicea. LIQUID ORAL 20171120 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. SILVER NITRATE; ASTRAGALUS NUTTALLII LEAF; CALCIUM SULFATE ANHYDROUS; CUPRIC ARSENITE; HERRING SPERM DNA; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; RHODODENDRON TOMENTOSUM LEAFY TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SACCHAROMYCES CEREVISIAE RNA; SILICON DIOXIDE 6; 3; 6; 12; 4; 6; 6; 6; 1; 6; 4; 6 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_M]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL N 20181231 66096-724_05607c5d-ada9-497a-8bb4-b847dbb974fa 66096-724 HUMAN OTC DRUG Detox Drainage Kidney Apis Mel, Berber Vulg, Chimaphila Umb, Cuprum Met, Equisetum Hyem, Formica, Nat Sulphuricum, Sabal, Sarsaparilla, Solidago, Uva Ursi. LIQUID ORAL 20170321 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. APIS MELLIFERA; BERBERIS VULGARIS ROOT BARK; CHIMAPHILA UMBELLATA; COPPER; EQUISETUM HYEMALE; FORMICA RUFA; SODIUM SULFIDE NONAHYDRATE; SAW PALMETTO; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; ARCTOSTAPHYLOS UVA-URSI LEAF 5; 3; 3; 14; 6; 6; 4; 3; 3; 3; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-725_1286b9cc-f99a-49cc-883f-5375f17ed827 66096-725 HUMAN OTC DRUG Detox Drainage Liver Boldo, Carduus Mar, Chelidonium Maj, Cinchona, Cynara, Fel Tauri, Hydrastis, Myrica, Nux Vomica, Stannum Met, Taraxacum. LIQUID ORAL 20170315 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS; CINCHONA OFFICINALIS BARK; CYNARA SCOLYMUS LEAF; BOS TAURUS BILE; GOLDENSEAL; MORELLA CERIFERA ROOT BARK; STRYCHNOS NUX-VOMICA SEED; TIN; TARAXACUM OFFICINALE 3; 3; 6; 3; 3; 4; 5; 3; 6; 8; 3 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-726_ba69f12e-4be9-4148-85b6-512cfabc1552 66096-726 HUMAN OTC DRUG Damiana Complex Agnes Castus, Avena Sativa, Damiana, Gelsemium Sempervirens, Ignatia Amara, Lycopodium Clavatum, Orchitinum, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum. LIQUID ORAL 20150819 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. CHASTE TREE; AVENA SATIVA FLOWERING TOP; TURNERA DIFFUSA LEAFY TWIG; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; SUS SCROFA TESTICLE; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM 3; 3; 3; 12; 12; 12; 12; 12; 3; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66096-727_f25e7dd9-4ccb-45f6-aa2a-c2ba6c8dff34 66096-727 HUMAN OTC DRUG OHM Sleep Well Avena Sativa, Coffea Cruda, Ignatia Amara, Nux Vomica, Passiflora, Incarnata, Stramonium, Valeriana Officinalis. LIQUID ORAL 20170421 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; DATURA STRAMONIUM; VALERIAN 4; 30; 12; 30; 4; 30; 4 [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL N 20181231 66096-728_0247d3de-5807-43c6-bceb-b433d1b17c87 66096-728 HUMAN OTC DRUG Dandruff Relief Baptisia Tinctoria, Borax, Calendula, Candida Albicans, Eugenia Caryophyllata,Fucus Vesiculosus, Kali Iodatum, Symphytum Officinale, Thuja Occidentalis. SHAMPOO TOPICAL 20151102 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. BAPTISIA TINCTORIA ROOT; SODIUM BORATE; CALENDULA OFFICINALIS FLOWERING TOP; CANDIDA ALBICANS; CLOVE; FUCUS VESICULOSUS; POTASSIUM IODIDE; COMFREY ROOT; THUJA OCCIDENTALIS LEAFY TWIG 1; 1; 1; 30; 1; 1; 2; 6; 1 [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL; [hp_X]/240mL N 20181231 66096-731_0667f0bc-7e7f-4e12-a153-78f5b598f208 66096-731 HUMAN OTC DRUG Rhus Tox 4X, 8X, 12X Rhus Toxicodendron. LIQUID ORAL 20171117 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. TOXICODENDRON PUBESCENS LEAF 4 [hp_X]/30mL N 20191231 66096-732_77dd0628-f71e-4ce1-ad1e-32402e023587 66096-732 HUMAN OTC DRUG NailWellness Antimonium Crudum, Arsenicum Album, Graphites, Mercurius Solubilis, Sepia, Silicea, Thuja Occidentalis, Ustilago Maidis, Zincum Metallicum, LIQUID TOPICAL 20171117 UNAPPROVED HOMEOPATHIC OHM PHARMA INC. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; GRAPHITE; MERCURIUS SOLUBILIS; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; USTILAGO MAYDIS; ZINC 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL N 20191231 66097-001_61530745-c9d5-f07a-e053-2991aa0a4077 66097-001 HUMAN OTC DRUG SISLEYA Global Anti-Age Hand care SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20130120 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. Sisley AVOBENZONE; OCTINOXATE; OCTISALATE 20; 50; 30 mg/g; mg/g; mg/g N 20181231 66097-002_24f1ed75-2006-4b85-a9e3-b3e435d3f2ff 66097-002 HUMAN OTC DRUG SUNLEYA Age minimizing sun care SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20130121 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. Sisley AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 50; 50; 40 mg/g; mg/g; mg/g; mg/g N 20181231 66097-003_44d08d5d-2f13-4aec-b051-12c145f00339 66097-003 HUMAN OTC DRUG SUNLEYA Age minimizing sun care SPF 50 plus AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130121 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. Sisley AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 150; 50; 100 mg/g; mg/g; mg/g; mg/g N 20181231 66097-004_15e8fdee-9aad-4a8f-bced-953db3e4bae9 66097-004 HUMAN OTC DRUG SUPER CREME SOLAIRE CORPS Body sun care SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20130121 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. Sisley AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 50; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 66097-005_610a6f19-7144-2907-e053-2a91aa0a44b5 66097-005 HUMAN OTC DRUG SUPER SOLAIRE SUN SENSITIVE AREAS COLORLESS SPF 30 SPF 30 TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20130123 20211231 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. Sisley TITANIUM DIOXIDE; ZINC OXIDE 95; 187.5 mg/g; mg/g N 20191231 66097-006_610a6f19-7155-2907-e053-2a91aa0a44b5 66097-006 HUMAN OTC DRUG SUPER SOLAIRE sun sensitive areas tinted SPF 30 TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20130123 20211231 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. Sisley TITANIUM DIOXIDE; ZINC OXIDE 95; 187.5 mg/g; mg/g N 20181231 66097-007_280ba9fa-acd8-00bc-e054-00144ff88e88 66097-007 HUMAN OTC DRUG Tinted Sunscreen SPF 30 1-Natural TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20151222 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. - Sisley TITANIUM DIOXIDE; ZINC OXIDE 154.3; 108.9 mg/mL; mg/mL N 20181231 66097-008_280bb216-308a-4db9-e054-00144ff8d46c 66097-008 HUMAN OTC DRUG Tinted Sunscreen SPF 30 2-Golden TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20151223 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. - Sisley TITANIUM DIOXIDE; ZINC OXIDE 147.4; 108.9 mg/mL; mg/mL N 20181231 66097-009_610a6f19-7165-2907-e053-2a91aa0a44b5 66097-009 HUMAN OTC DRUG Tinted Sunscreen Cream SPF 30 4-Deep Amber TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170315 OTC MONOGRAPH NOT FINAL part352 C.F.E.B. - Sisley TITANIUM DIOXIDE; ZINC OXIDE 129.3; 108.9 mg/mL; mg/mL N 20181231 66116-223_42a9d92c-f6d9-42b8-a58c-fd51cca49258 66116-223 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 MedVantx, Inc. AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 66116-234_ce37a533-6f4c-4263-a8c6-d61b76d56adb 66116-234 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19730112 ANDA ANDA083177 MedVantx, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 66116-255_937ecebf-af54-431b-a326-3b4662853b49 66116-255 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 19900930 ANDA ANDA062702 MedVantx, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 66116-300_0e7e3947-be0e-4407-a424-a365f99f4350 66116-300 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA075776 MedVantx, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 66116-310_cd217f3c-5a6e-4def-a125-e70ad4874e9b 66116-310 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075752 MedVantx, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 66116-316_bb0802ae-207d-40c7-8e80-4dcc8ebe94e2 66116-316 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 MedVantx, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 66116-329_690f0271-5966-4015-8bb2-56f941f14c50 66116-329 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20070222 ANDA ANDA077048 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-344_ff5aa574-0ef8-482f-815f-32357a959707 66116-344 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 MedVantx, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 66116-346_dad83d68-f35a-42ca-a65c-f95677e1c9ca 66116-346 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20060425 ANDA ANDA076056 MedVantx, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 66116-352_ab1bacf9-00fa-4332-8cb8-a5071b2a7723 66116-352 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077038 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-353_9171c747-d032-4732-b067-17cd9c77357a 66116-353 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077038 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-357_9426f88d-2f3f-4dc9-ba17-f4bc0be91963 66116-357 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 19930324 ANDA ANDA073137 MedVantx, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 66116-358_6b3ca748-7172-4c53-b5ae-7e17dad918eb 66116-358 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 MedVantx, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 66116-359_2c04fc9b-5f83-4a3a-87e3-2b07affd0ad0 66116-359 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070974 MedVantx, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 66116-360_a53e29b3-7436-419f-ad6c-0a805d97ab1a 66116-360 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20110718 ANDA ANDA074388 MedVantx, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 66116-361_b4647b22-9a70-4259-a8f6-fac0ce1ac5c5 66116-361 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20110913 ANDA ANDA076373 MedVantx, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 66116-366_c6c3b8b0-4932-4cee-af0b-f14425925c50 66116-366 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 MedVantx, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66116-367_c6c3b8b0-4932-4cee-af0b-f14425925c50 66116-367 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 MedVantx, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66116-368_c6c3b8b0-4932-4cee-af0b-f14425925c50 66116-368 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 MedVantx, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66116-369_f8f30cc7-94e3-49f4-84c5-1f43ccdabc35 66116-369 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 MedVantx, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 66116-370_5fb922d2-e71b-4f67-847e-92d820ebc3d6 66116-370 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20100727 ANDA ANDA075978 MedVantx, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 66116-371_1743d408-6eac-41ae-8f80-0053f9d24e85 66116-371 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 MedVantx, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-372_8d53dc31-a51f-4326-a6cd-5aa6aebda3ed 66116-372 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 MedVantx, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 66116-375_918887d8-5c36-49e9-832d-d03a1d15f2a8 66116-375 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 MedVantx, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 66116-376_478b6915-9d73-4681-bee0-0f4540fd4839 66116-376 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 MedVantx, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-377_c3162f51-f3d1-4269-8d56-e56dc9da43fd 66116-377 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 MedVantx, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-378_5fb922d2-e71b-4f67-847e-92d820ebc3d6 66116-378 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20100727 ANDA ANDA075978 MedVantx, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 66116-388_9479a921-2778-47be-9833-23106e4e64c3 66116-388 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20080118 ANDA ANDA065248 MedVantx, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 66116-389_f9bd1793-4e13-47e0-98cd-30ee06390a64 66116-389 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 MedVantx, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 66116-390_197c51b6-d0b8-4cd6-89f6-be666168092c 66116-390 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077038 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-391_26ce821b-bb78-4afd-96ee-528b1dbf88c4 66116-391 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075752 MedVantx, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 66116-392_3ba4c6e0-cb83-43b5-a623-1f2af9c2b07c 66116-392 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20061002 ANDA ANDA078008 MedVantx, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66116-393_f6bf82d1-b768-49de-bc6c-1078dfc3c359 66116-393 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20061002 ANDA ANDA078008 MedVantx, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66116-398_9ef147ae-fcc5-4fd1-b65c-7a37dae89b91 66116-398 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060201 ANDA ANDA065215 MedVantx, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 66116-400_eac25cfc-92cb-411c-b109-25731815b936 66116-400 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 MedVantx, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 66116-401_b8585313-58f6-42af-bab7-e524ccdacd08 66116-401 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20091110 ANDA ANDA078254 MedVantx, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 66116-402_6b1141e6-f233-4440-87c2-cd349d76d1ec 66116-402 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071523 MedVantx, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 66116-403_e65e3c28-a40b-4daa-8fd5-29f112575b68 66116-403 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 MedVantx, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66116-404_0060d1b1-4cfc-4b69-86a8-9bd44a071e94 66116-404 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 MedVantx, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66116-405_789d1ece-181b-4eca-b449-f15b6071de90 66116-405 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-406_cc8258c3-6265-4b26-a1bf-df6476cc962a 66116-406 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 MedVantx, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 66116-407_38d9d7d7-9f81-4517-acee-e34232215800 66116-407 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20080131 ANDA ANDA078787 MedVantx, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 66116-408_84e3af60-8814-49f6-918e-a4e1c702aa05 66116-408 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077691 MedVantx, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 66116-409_b6052b11-a7c1-4f55-8ef5-239541c466ff 66116-409 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-412_c525925d-e16d-434c-a25d-4c5ff1b5ef24 66116-412 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 MedVantx, Inc. DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 66116-413_2fbc01fb-b787-4ff1-bb9f-280dfe975531 66116-413 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET, FILM COATED ORAL 20100922 ANDA ANDA076840 MedVantx, Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 66116-414_7b7f90ab-8336-48a2-9762-c23a02f9172e 66116-414 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 MedVantx, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 66116-415_69605072-f130-4054-95b0-ff3c34554fb9 66116-415 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101003 ANDA ANDA090382 MedVantx, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 66116-417_010ea8e3-4955-4332-8cca-f45977ab56c6 66116-417 HUMAN OTC DRUG CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20091019 ANDA ANDA078862 MedVantx, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 66116-418_1e505c90-79e4-4267-83c4-2fbb93d75cc6 66116-418 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20111024 ANDA ANDA065153 MedVantx, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 66116-419_40eb0186-e55e-4f93-9233-996297910dbd 66116-419 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20120316 ANDA ANDA018413 MedVantx, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 66116-427_6a957e2e-f1ea-416b-81de-f273234e6db9 66116-427 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20120318 ANDA ANDA074497 MedVantx, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 66116-428_a9942f9c-5929-4b9b-aa27-64f7f9b164e3 66116-428 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20080206 ANDA ANDA075710 MedVantx, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 66116-429_40a98410-9568-4278-959e-ca3517a9b119 66116-429 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070906 ANDA ANDA076373 MedVantx, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 66116-432_3f626e54-b043-4556-9568-ace556cff9e9 66116-432 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20120419 ANDA ANDA076802 MedVantx, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 66116-433_a098f1d0-577e-474e-baab-d200c896a294 66116-433 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100611 ANDA ANDA076269 MedVantx, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 66116-434_b1894876-1824-4f87-95ed-d2a805683e15 66116-434 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20051003 ANDA ANDA076618 MedVantx, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-435_cf8f5d60-a2f8-4fa4-ba39-6d175cf3abce 66116-435 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100427 ANDA ANDA077630 MedVantx, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 66116-436_cbcb4427-7a99-467c-915f-a8b4c90e2832 66116-436 HUMAN PRESCRIPTION DRUG Tri-Sprintec norgestimate and ethinyl estradiol KIT 20110125 ANDA ANDA075808 MedVantx, Inc. E 20171231 66116-437_c6bf064f-e5d9-42e3-b2e5-86ae3836d357 66116-437 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 MedVantx, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 66116-439_aafd2b0f-435a-4805-9b17-c02f99df59d5 66116-439 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20101014 ANDA ANDA077936 MedVantx, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66116-443_d224143d-2199-4969-a64f-dc2e6b865ec4 66116-443 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060720 ANDA ANDA077936 MedVantx, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66116-444_6fa84b06-4292-43c2-888e-3e62b4c19a3d 66116-444 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110913 ANDA ANDA075435 MedVantx Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 66116-445_16bda7b5-a5a5-4478-9df3-beb396bd677f 66116-445 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20120424 ANDA ANDA077048 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-446_213502a2-f667-4da6-a4b9-462eb303c401 66116-446 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20100323 ANDA ANDA076846 MedVantx, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 66116-447_0cca3e8d-bf4d-4119-90b4-91144c73e226 66116-447 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 MedVantx, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-450_7306dad3-30ed-47ed-9fb9-d5d9e1ec5247 66116-450 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101220 ANDA ANDA077157 MedVantx, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 66116-452_f88c39fa-ed74-42f4-a886-c268daf8f3a6 66116-452 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101228 ANDA ANDA076958 MedVantx, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 66116-453_7125a96a-0e98-4984-8b57-a2e7a99b7b0d 66116-453 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20120320 ANDA ANDA076001 MedVantx, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-455_5665e444-b914-460d-a023-8a241c18cbb6 66116-455 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20071108 ANDA ANDA077048 MedVantx, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-464_f1a9e2fc-f75a-46a6-82f1-c11fa0b281a2 66116-464 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 MedVantx, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-467_c0e3e84e-2c4e-45d9-b2e2-7c4d208eca67 66116-467 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 MedVantx, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 66116-470_b61cdce5-9fb5-4901-a768-4282a684db3f 66116-470 HUMAN PRESCRIPTION DRUG Gianvi Drospirenone and ethinyl estradiol KIT 20101022 NDA NDA021676 MedVantx, Inc. E 20171231 66116-471_26b0400e-edce-44f2-84de-67f178488683 66116-471 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide SPRAY, METERED NASAL 20110406 ANDA ANDA078104 MedVantx, Inc. TRIAMCINOLONE ACETONIDE 55 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 66116-473_04d66f28-86eb-4c3e-b31f-26e5324cf48b 66116-473 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20110407 ANDA ANDA090510 MedVantx, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 66116-477_bc4ce768-a615-4458-9d60-baeada6886cd 66116-477 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 MedVantx, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 66116-478_ee4c9c41-8ac4-4647-a765-731d8376c2d2 66116-478 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20111116 ANDA ANDA065096 MedVantx, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 66116-479_16a686e6-63f4-478f-a673-02dde9474eda 66116-479 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20090618 ANDA ANDA065359 MedVantx, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 66116-480_c4022360-6081-451e-806e-4632a05c6e57 66116-480 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 MedVantx, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 66116-481_892aa268-0790-4e2c-8faa-d8cbeb200abd 66116-481 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20111221 ANDA ANDA076077 MedVantx, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 66116-482_d7aa2791-95d9-4732-afe4-89d70f01d152 66116-482 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 MedVantx, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 66116-484_a63d3ace-768f-4e1b-a5e9-dad1817453b9 66116-484 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110201 UNAPPROVED DRUG OTHER MedVantx, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 E 20171231 66116-485_1acbda65-ead7-4947-841c-8788c3ee4c00 66116-485 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 MedVantx, Inc. PREDNISONE 5 mg/1 E 20171231 66116-487_f754cce8-1871-4bd6-9082-86607da9c8ae 66116-487 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 MedVantx, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 66116-494_89033966-72f2-44b3-8335-3d12e82f27fe 66116-494 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA076999 MedVantx, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 66116-498_a0bd00e9-9813-4ea7-b640-1eb59202751b 66116-498 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 MedVantx, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 66116-503_b24549cf-6c14-4e49-8756-5bd6d88ec6b8 66116-503 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA078605 MedVantx, Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 66116-504_a3ae5cba-f495-4593-b8fc-5ada34790745 66116-504 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 MedVantx, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 66116-507_d50f36f5-5f08-444b-8c9f-11774629273f 66116-507 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 MedVantx, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 66116-508_6fecbc15-915c-4434-b9e3-cfc1aa33a1ba 66116-508 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride TABLET ORAL 20040609 ANDA ANDA076089 MedVantx, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 66116-509_60bf8e22-284b-4dc0-9c03-694813cc89ac 66116-509 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065153 MedVantx, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 66116-510_8267f4f7-a557-400e-a1d8-07825c39f9ef 66116-510 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040729 ANDA ANDA076077 MedVantx, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 66116-512_4b4d9e67-2cca-4c64-80f2-b4f03950b6b3 66116-512 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19900930 ANDA ANDA072488 MedVantx, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 66116-513_edde25d4-9ac3-4b11-8b65-be221e06f37e 66116-513 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20080125 ANDA ANDA081297 MedVantx, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 66116-516_5a0e55c9-950b-4d23-b125-e6ffd42b518f 66116-516 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA077655 MedVantx, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 66116-518_b499b520-e7d8-4a21-8ff1-222925577d38 66116-518 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 19970912 ANDA ANDA075165 MedVantx, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 66116-521_47072dcb-fe13-4aa3-849b-b7b3fbb94c51 66116-521 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20111213 ANDA ANDA091368 MedVantx, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 66116-524_4e9ac94f-4d85-4731-8b7f-6188209b4a9c 66116-524 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin Monohydrate POWDER, FOR SUSPENSION ORAL 20080922 ANDA ANDA065419 MedVantx, Inc. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 66116-527_6a682677-4a99-43a5-a991-af7f2d69aca1 66116-527 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19950929 ANDA ANDA074421 MedVantx, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 66116-529_877417ef-7706-44cf-a8a7-1fec3e7a0266 66116-529 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20071214 ANDA ANDA070756 MedVantx, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66116-601_e186510b-9fa5-4325-b4ed-90aa0c5e181f 66116-601 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 MedVantx, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] E 20171231 66116-603_da5df185-b694-4855-b31f-24fed4b806d7 66116-603 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 19981211 ANDA ANDA089081 MedVantx, Inc. PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 66116-604_ff3765cb-352c-48ad-a1a0-04a1777f1713 66116-604 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 MedVantx, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 66116-605_adb0c2bc-adc3-4f53-a3df-65c48c02d2e4 66116-605 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060718 ANDA ANDA040622 MedVantx, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 66116-607_ca2ed054-b1a5-4174-b107-a26d8c9b31b2 66116-607 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 MedVantx, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 66116-810_96e73d2d-4fd5-4ab0-99d9-6d396231645f 66116-810 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 19950406 ANDA ANDA074141 MedVantx, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 66116-821_3bf1718a-fedc-4834-831e-b3b044f80ee6 66116-821 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19900930 ANDA ANDA061926 MedVantx, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 66116-841_c41f391a-f83c-4779-b5cb-4019c959b6ce 66116-841 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075752 MedVantx, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 66125-001_c973aeee-c119-4426-ab51-f174cdd4acea 66125-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19900101 UNAPPROVED MEDICAL GAS Keene Medical Products, Inc. OXYGEN 99 L/100L E 20171231 66129-010_8cd1bbaf-1a66-4501-bac4-6ffc3242db3e 66129-010 HUMAN OTC DRUG Topiclear Skin Lightening Hydroquinone CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g E 20171231 66129-011_3f238fee-d6a7-461c-83ce-0d0310ef9fbd 66129-011 HUMAN OTC DRUG Topiclear Lemon HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g E 20171231 66129-012_a00a4385-86e1-4beb-a83f-8f6bc2c9776f 66129-012 HUMAN OTC DRUG Topiclear Cocoa Butter HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g E 20171231 66129-015_ece9fad2-01b6-4316-a743-9c85930ace28 66129-015 HUMAN OTC DRUG Topiclear Carrot HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g E 20171231 66129-020_845405e7-dab2-425f-9a87-7e9ec1debb42 66129-020 HUMAN OTC DRUG Topiclear Hydroquinone LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL E 20171231 66129-028_207152a7-4ca6-4dbe-b2c4-c1cafb1f6ab4 66129-028 HUMAN OTC DRUG Topiclear Xtra beauty HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL E 20171231 66129-031_57f4cf56-d0e0-498c-8835-eacdf01eff36 66129-031 HUMAN OTC DRUG Topiclear Xtra lemon beauty HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL E 20171231 66129-032_06de2dba-989d-49dc-bc24-53ef09729984 66129-032 HUMAN OTC DRUG Topiclear Cocoa Butter beauty HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL E 20171231 66129-035_e84c9401-4f99-4e39-be46-ea8dd05404c6 66129-035 HUMAN OTC DRUG Topiclear Xtra beauty HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL E 20171231 66129-040_47abd276-5364-4023-909c-cfce6b763565 66129-040 HUMAN OTC DRUG TOPICLEAR SKIN LIGHTENING HYDROQUINONE GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE 1 g/50g E 20171231 66129-045_c97cc9f9-1f35-44cc-a85c-babf4f4140ae 66129-045 HUMAN OTC DRUG Topiclear Carrot Hydroquinone GEL TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange Inc HYDROQUINONE .6 g/30g E 20171231 66129-101_c02a14bc-4e03-4a4f-9288-c3092dccbe0c 66129-101 HUMAN OTC DRUG African Formula Skin Lightening HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g E 20171231 66129-102_e7d9b1c6-baf0-4f26-85de-16ea23283ebd 66129-102 HUMAN OTC DRUG African Formula Black Hydroquinone CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE 1 g/50g E 20171231 66129-105_9efe63d1-188f-47a2-8052-5b5590a493b0 66129-105 HUMAN OTC DRUG African Formula Carrot Hydroquinone CREAM TOPICAL 20110311 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE 1 g/50g E 20171231 66129-107_39433171-253e-4302-b7a5-b1490d2af2e6 66129-107 HUMAN OTC DRUG African Formula Skin Lightening HYDROQUINONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 5; 1.25 mL/250mL; mL/250mL E 20171231 66129-110_b03dcf0d-32c9-4032-b0e0-3dcab0c53bc2 66129-110 HUMAN OTC DRUG SH 18 Whitening HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g E 20171231 66129-111_b0740078-49fd-4c30-9f8a-c18133918ecf 66129-111 HUMAN OTC DRUG Movate Skin Lightening Lemon HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; PADIMATE O 1; .25 g/50g; g/50g E 20171231 66129-112_2517e106-ef70-4808-b260-3d5fffebade5 66129-112 HUMAN OTC DRUG SH18 Skin Lightening HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL E 20171231 66129-113_462973aa-bc9d-4ad0-a6cc-2ebb627a8fc1 66129-113 HUMAN OTC DRUG SH18 Caviar Beauty HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; CAVIAR 10; 2.75 mL/500mL; mL/500mL E 20171231 66129-114_23bba31c-d194-4056-8ce9-3841c7745455 66129-114 HUMAN OTC DRUG SH18 HYDROQUINONE GEL TOPICAL 20110623 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE 1 g/50g E 20171231 66129-115_2c35a7e3-d86a-4ef1-8efe-095830570aae 66129-115 HUMAN OTC DRUG Movate Carrot HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE 1 g/50g E 20171231 66129-116_658e0e73-6446-4ff7-9ef2-7e76adc78693 66129-116 HUMAN OTC DRUG SH18 Ultra Harmonie Carrot Beauty HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL E 20171231 66129-121_df9b1a41-b2d8-45fc-948c-987d47d65510 66129-121 HUMAN OTC DRUG Top White HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g E 20171231 66129-123_3cee6456-1e0a-45c6-a459-8766e360cb93 66129-123 HUMAN OTC DRUG Top White Skin Lightening HYDROQUINONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL E 20171231 66129-134_dd233d74-59d9-42df-9120-0b9aef99d654 66129-134 HUMAN OTC DRUG DERMACLAIR SKIN LIGHTENING HYDROQUINONE GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE 1 g/50g E 20171231 66129-140_decdd9ec-33bc-4e0b-afda-3816afdf9497 66129-140 HUMAN OTC DRUG Movate Skin Lightening Hydroquinone CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE .6; .15 g/30g; g/30g E 20171231 66129-141_087062a9-da8f-4adf-8446-0d6d3303eed7 66129-141 HUMAN OTC DRUG Movate Lemon Hydroquinone GEL TOPICAL 20110125 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange Inc HYDROQUINONE .6 g/30g E 20171231 66129-144_2464e136-0c96-4a34-be17-97b12b6eb5cc 66129-144 HUMAN OTC DRUG PRECIOUS BEAUTY SKIN LIGHTENING HYDROQUINONE GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE .6 g/30g E 20171231 66129-149_62967136-96e1-43b2-9e12-cc250de01e10 66129-149 HUMAN OTC DRUG HOT MOVATE HYDROQUINONE GEL TOPICAL 20110712 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE .6 g/30g E 20171231 66129-151_c07479e0-a230-4b0c-8996-b81b0fff5cd4 66129-151 HUMAN OTC DRUG Caro Light HYDROQUINONE CREAM TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE 1 g/50g E 20171231 66129-210_60585dda-3d51-43ca-8835-b09c81c43572 66129-210 HUMAN OTC DRUG Crusader Ultra Skin Lightening HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; PADIMATE O 1.14; .285 g/57g; g/57g E 20171231 66129-310_1080e7d6-61a0-42ab-a707-b6792c4d7c76 66129-310 HUMAN OTC DRUG Crusader Skin Lightening HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; LANOLIN; PADIMATE O 1; .5; .25 g/50g; g/50g; g/50g E 20171231 66129-410_132eb45f-6d93-468e-8707-d12e0e0bd307 66129-410 HUMAN OTC DRUG Idole Skin Lightening HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g E 20171231 66129-411_64be87ec-61d8-4a9a-9e54-37aa0e329bcd 66129-411 HUMAN OTC DRUG Idole Lemon HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g E 20171231 66129-412_c9a5ea3d-3c36-4cc9-b5f4-c1ec40bd7c90 66129-412 HUMAN OTC DRUG IDOLE BLACK HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE 1 g/50g E 20171231 66129-413_1e1b23bf-ac18-4622-a899-0c344278f7a4 66129-413 HUMAN OTC DRUG Idole Natural Organic Skin Lightening HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g E 20171231 66129-414_fd0a184c-c47f-41dc-b179-a059fbb9547f 66129-414 HUMAN OTC DRUG Idole Skin Lightening Hydroquinone GEL TOPICAL 20110311 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE .6 g/30g E 20171231 66129-430_d0886304-6d3e-4b44-b27a-a3fbca923106 66129-430 HUMAN OTC DRUG Idole Beauty HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 5; 1.25 mL/250mL; mL/250mL E 20171231 66129-434_b24a29fc-1037-4303-bc8f-a28737bfe3f8 66129-434 HUMAN OTC DRUG Idole Natural Organic HYDROQUINONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10.4; 2.6 mL/520mL; mL/520mL E 20171231 66129-444_72e5a0ea-706c-4061-a50a-31ec2acb03bb 66129-444 HUMAN OTC DRUG Idole Natural Organic Skin Lightening HYDROQUINONE GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE .6 g/30g E 20171231 66129-445_5f20f718-fcb6-4ecb-88b4-145ca0cc0e61 66129-445 HUMAN OTC DRUG IDOLE CARROT HYDROQUINONE GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE .6 g/30g E 20171231 66129-470_72558464-02ff-4fad-a4c6-72978e8724e1 66129-470 HUMAN OTC DRUG Idole Intense HYDROQUINONE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 5; 1.25 mL/250mL; mL/250mL E 20171231 66129-510_eb8c46b0-48ff-4e36-a98d-62bc11fbdf70 66129-510 HUMAN OTC DRUG Metasol Skin Lightening HYDROQUINONE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; PADIMATE O 1; .25 g/50g; g/50g E 20171231 66129-540_2cb90a33-8cc6-414e-aedc-30c9d77f5420 66129-540 HUMAN OTC DRUG Metasol HYDROQUINONE GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; BENZOPHENONE 1; .05 g/50g; g/50g E 20171231 66129-810_4d9d9cc4-2a34-4eb9-a2d2-9e7dffe17568 66129-810 HUMAN OTC DRUG Topiclear Paris HYDROQUINONE CREAM TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 1; .25 g/50g; g/50g E 20171231 66129-830_4c94e928-6f71-48a5-b77e-a827a6928201 66129-830 HUMAN OTC DRUG Topiclear Paris Beauty HYDROQUINONE LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE; OCTINOXATE 10; 2.5 mL/500mL; mL/500mL E 20171231 66129-840_a91b5bd4-f361-4347-b082-e083096470e8 66129-840 HUMAN OTC DRUG Topiclear Paris HYDROQUINONE GEL TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part358A International Beauty Exchange HYDROQUINONE .6 g/30g E 20171231 66130-001_f484893b-be3e-44d0-8452-69608f1fe443 66130-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Lubbock Oxygen & Medical Gases Inc. OXYGEN 99 L/100L E 20171231 66134-015_6dc377d1-8a9d-4d4e-b958-e8485efd9181 66134-015 HUMAN OTC DRUG Safe Sea OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20150107 OTC MONOGRAPH NOT FINAL part352 SASA Cosmetics OCTINOXATE; ZINC OXIDE 75; 20 mg/g; mg/g N 20181231 66134-040_452c2fbf-ab88-48e9-a0b0-7f876a2c93a0 66134-040 HUMAN OTC DRUG Safe Sea SPF 40 OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20150107 OTC MONOGRAPH NOT FINAL part352 SASA Cosmetics OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; TITANIUM DIOXIDE 75; 50; 35; 30; 15 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 66134-042_6b845f30-ae74-4f32-b146-88b682391a72 66134-042 HUMAN OTC DRUG Safe Sea SPF 40 OCTINOXATE, OCTISALATE, OCTOCRYLENE. AVOBENZONE, TITANIUM DIOXIDE, HOMOSALATE SPRAY TOPICAL 20150107 OTC MONOGRAPH NOT FINAL part352 SASA Cosmetics OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE; TITANIUM DIOXIDE; HOMOSALATE 75; 50; 60; 30; 1; 70 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 66134-050_46af1cb0-86e5-4a67-b80d-fb1b0c39440c 66134-050 HUMAN OTC DRUG Safe Sea SPF 50 OCTINOXATE, OCTISALATE, AVOBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20150107 OTC MONOGRAPH NOT FINAL part352 SASA Cosmetics OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 75; 50; 50; 20 mg/g; mg/g; mg/g; mg/g N 20181231 66134-052_8d715933-70eb-4eb2-b6ea-bff9828e060f 66134-052 HUMAN OTC DRUG Safe Sea SPF 50 KIDS OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20150107 OTC MONOGRAPH NOT FINAL part352 SASA Cosmetics OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 75; 50; 50; 20 mg/g; mg/g; mg/g; mg/g N 20181231 66134-060_4df72aa6-36a4-4e30-87ed-b6f1c3c787db 66134-060 HUMAN OTC DRUG Safe Sea SPF 60 OCTINOXATE, OCTISALATE, AVOBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20150107 OTC MONOGRAPH NOT FINAL part352 SASA Cosmetics OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 75; 50; 50; 20 mg/g; mg/g; mg/g; mg/g N 20181231 66141-640_6298478d-16d8-4901-8770-e4224cb802c9 66141-640 HUMAN OTC DRUG Thursday Plantation Tea Tree Antiseptic OIL TOPICAL 20100301 UNAPPROVED DRUG OTHER Integria Healthcare Ballina TEA TREE OIL 25 mL/25mL N 20181231 66141-641_f8b79c4b-e6fa-44f9-89d9-67bddda77289 66141-641 HUMAN OTC DRUG Thursday Plantation Tea Tree Antiseptic OIL TOPICAL 20100301 UNAPPROVED DRUG OTHER Integria Healthcare Ballina AUSTRALIAN TEA TREE OIL 50 mL/50mL N 20181231 66141-643_568dd84f-a59f-4ce3-aaf6-6180045b8490 66141-643 HUMAN OTC DRUG Thursday Plantation Tea Tree Antiseptic Cream CREAM TOPICAL 20100301 UNAPPROVED DRUG OTHER Integria Healthcare Ballina AUSTRALIAN TEA TREE OIL 5 g/100g N 20181231 66141-644_bbe03f6e-37db-49c2-8930-77727aba77bf 66141-644 HUMAN OTC DRUG Thursday Plantation Tea Tree Antiseptic OINTMENT TOPICAL 20100301 UNAPPROVED DRUG OTHER Integria Healthcare Ballina TEA TREE OIL 3 g/50g N 20181231 66155-544_5fb7e072-a8ca-42a7-8abf-7ca20e993504 66155-544 HUMAN OTC DRUG Surgent Antiseptic CHLOROXYLENOL SOAP TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333E SunCoast Paper Inc. CHLOROXYLENOL 3 mg/mL N 20181231 66171-123_60f04e6e-4157-c25a-e053-2a91aa0a3291 66171-123 HUMAN OTC DRUG Dr.Denese SPF 30 Defense Day ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20110521 OTC MONOGRAPH FINAL part352 SkinScience Labs, Inc ZINC OXIDE; OCTINOXATE 7.5; 7.5 g/100g; g/100g N 20181231 66184-100_1d1ceed9-8799-4c2b-9cd2-0160183e0ea6 66184-100 HUMAN OTC DRUG Adidas for Women Action 3 Fresh Aluminum Tetrachlorohydrex GLY STICK TOPICAL 20090101 OTC MONOGRAPH FINAL part350 Coty US LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18 mg/100g E 20171231 66184-105_d963f266-c6c4-41a8-a634-d329a1242ec1 66184-105 HUMAN OTC DRUG Adidas for Women Action 3 Intensive ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20090101 OTC MONOGRAPH FINAL part350 Coty US LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18 mg/100g E 20171231 66184-110_2fc9c7c5-afb3-464e-8268-65e6ae919415 66184-110 HUMAN OTC DRUG Adidas for Women Action 3 Pure ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20090101 OTC MONOGRAPH FINAL part350 Coty US LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18 mg/100g E 20171231 66184-115_20e1fd1b-64f7-4fa7-8e5c-496d3153ab02 66184-115 HUMAN OTC DRUG Adidas Action 3 Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20090101 OTC MONOGRAPH FINAL part350 Coty US LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18 mg/100g E 20171231 66184-120_f2d0c704-777a-4ca1-a661-ce9fab40c53d 66184-120 HUMAN OTC DRUG Adidas Action 3 Fresh ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20090101 OTC MONOGRAPH FINAL part350 Coty US LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18 mg/100g E 20171231 66184-125_bf2d6e88-af1f-4b59-8c77-9e9f109a2ace 66184-125 HUMAN OTC DRUG Adidas Action 3 Intense ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20090101 OTC MONOGRAPH FINAL part350 Coty US LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18 mg/100g E 20171231 66184-130_71ead72e-8e25-4da8-afe3-9f146f6c4a7c 66184-130 HUMAN OTC DRUG Adidas Action 3 Intense ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20090101 OTC MONOGRAPH FINAL part350 Coty US LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18 mg/100g E 20171231 66184-135_a2b609ef-b068-4b89-b2cc-aa2a8e1e1754 66184-135 HUMAN OTC DRUG Adidas Action 3 Pure ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20090101 OTC MONOGRAPH FINAL part350 Coty US LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 18 mg/100g E 20171231 66184-140_b445cc87-0fbf-4654-a4b5-82d43d1e9e58 66184-140 HUMAN OTC DRUG Adidas Action 3 Control Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20090101 OTC MONOGRAPH FINAL part350 Coty US LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 14.2 g/79g E 20171231 66184-141_2a738aea-5090-4440-be4c-d35ef3e33107 66184-141 HUMAN OTC DRUG Adidas 24H Anti Perspirant Deep Energy 2.8 Aluminum Zirconium Tetrachlorhydrex GLY STICK TOPICAL 20121001 OTC MONOGRAPH FINAL part350 Coty US LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 12.6 g/79g E 20171231 66184-142_ef539225-ad8c-4e4e-bbba-379776d48e97 66184-142 HUMAN OTC DRUG Adidas 24H Anti Perspirant Dynamic Pulse 2.8 Aluminum Zirconium Tetrachlorhydrex GLY STICK TOPICAL 20121001 OTC MONOGRAPH FINAL part350 Coty US LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 12.6 g/79g E 20171231 66184-143_f5513b25-d2c9-4c27-b638-03f289f63cc4 66184-143 HUMAN OTC DRUG Adidas 24H Anti Perspirant Pure Game 2.8 Aluminum Zirconium Tetrachlorhydrex GLY STICK TOPICAL 20121001 OTC MONOGRAPH FINAL part350 Coty US LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 12.6 g/79g E 20171231 66184-150_76ac8955-4550-452d-8360-f50db17a82c4 66184-150 HUMAN OTC DRUG Sally Hansen Dry Chapped Hand Creme 24 HR Moisture Dimethicone CREAM TOPICAL 20120101 OTC MONOGRAPH FINAL part332 Coty US LLC DIMETHICONE 960 mg/96g N 20181231 66184-151_193413f0-f2ad-465e-95d4-590be44b96f3 66184-151 HUMAN OTC DRUG Sally Hansen No More Fungus Undecylenic Acid LIQUID TOPICAL 20120101 OTC MONOGRAPH FINAL part333C Coty US LLC UNDECYLENIC ACID .23125 g/39.01mL N 20181231 66184-152_bd4d2e9c-b655-4474-9da1-f915cbb08131 66184-152 HUMAN OTC DRUG Sally Hansen Cracked Heel Repair Creme 24 HR Moisture Dimethicone CREAM TOPICAL 20120101 OTC MONOGRAPH FINAL part332 Coty US LLC DIMETHICONE 1.133 g/113g E 20171231 66184-153_eca952fd-dc89-4c39-a51f-dbb04f823cad 66184-153 HUMAN OTC DRUG Sally Hansen Ouch-Relief Wax Kit Benzocaine KIT TOPICAL 20120101 OTC MONOGRAPH FINAL part333B Coty US LLC N 20181231 66184-154_5dc5d42a-45ae-400d-8ddd-b80bd720436b 66184-154 HUMAN OTC DRUG Sally Hansen Ouch-Relief Wax Strip Kit Benzocaine KIT TOPICAL 20120101 OTC MONOGRAPH FINAL part333B Coty US LLC N 20181231 66184-155_016f9092-f2ba-44f7-81dd-a1f4fd694fea 66184-155 HUMAN OTC DRUG Sally Hansen Microwavable Eybrow, Face and Lip Wax Kit Benzocaine KIT TOPICAL 20120101 OTC MONOGRAPH FINAL part333B Coty US LLC N 20181231 66184-156_a0e83e9d-1448-4c18-b593-3058e2095d8e 66184-156 HUMAN OTC DRUG Sally Hansen Ouch-Relief Numbing Wipes Benzocaine CLOTH TOPICAL 20150101 OTC MONOGRAPH FINAL part333B Coty US LLC BENZOCAINE .0543 g/1 N 20181231 66184-160_61305f4e-6ddc-7b4f-e053-2a91aa0a64e2 66184-160 HUMAN OTC DRUG Sally Hansen Zero bump bikini PRAMOXINE HYDROCHLORIDE SPRAY TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part348 Coty US LLC PRAMOXINE HYDROCHLORIDE 10 mg/mL N 20181231 66184-400_e71e7dfa-968d-4619-9932-4fa2b7ef6519 66184-400 HUMAN OTC DRUG ck one3-in-1face makeup with SPF8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 7.5; .6 mL/30mL; mL/30mL E 20171231 66184-401_e837b008-0ff4-4a8d-943c-a61ce2082124 66184-401 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen 050 Ivory Titanium Dioxide and Octinoxate LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE .302; .606 g/30mL; g/30mL E 20171231 66184-402_d105bde0-f783-4ccf-8c2e-591ca8749444 66184-402 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen 350 Warm Sand Titanium Dioxide and Octinoxate LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE .302; .606 g/30mL; g/30mL E 20171231 66184-405_240a0a22-eb1c-4884-a4f0-a6e94b69696b 66184-405 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 7.5; .6 mL/30mL; mL/30mL E 20171231 66184-410_1e00556d-f222-47c4-af45-8a225be20d0a 66184-410 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 7.5; .6 mL/30mL; mL/30mL E 20171231 66184-415_67903236-dad1-421d-972c-4bca1ce941d5 66184-415 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 7.5; .6 mL/30mL; mL/30mL E 20171231 66184-420_891a328d-d81e-4244-afa0-3e633fd0c0b8 66184-420 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 7.5; .6 mL/30mL; mL/30mL E 20171231 66184-425_714c3a9a-8472-4d8d-be16-7af988e851e1 66184-425 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 7.5; .6 mL/30mL; mL/30mL E 20171231 66184-430_ff1f61bf-fb95-4296-a969-bb996dfb7321 66184-430 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 7.5; .6 mL/30mL; mL/30mL E 20171231 66184-435_c219cb36-5d14-4e78-84b0-eeb261a86eda 66184-435 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen Titanium Dioxide LIQUID TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 7.5; .6 mL/30mL; mL/30mL E 20171231 66184-436_a73079b6-4688-41b6-9290-cbb2b9a7180b 66184-436 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen 850 Toffee Titanium Dioxide and Octinoxate LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE .302; .606 g/30mL; g/30mL E 20171231 66184-437_48ac482f-e7a1-45ea-80ad-1cc4f3e11bb0 66184-437 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen 900 Walnut Titanium Dioxide and Octinoxate LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE .302; .606 g/30mL; g/30mL E 20171231 66184-438_052f6f12-d319-4084-bf1d-3bfe5cb05f78 66184-438 HUMAN OTC DRUG ck one 3-in-1 face makeup with SPF 8 sunscreen 950 Espresso Titanium Dioxide and Octinoxate LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE .302; .606 g/30mL; g/30mL E 20171231 66184-440_4e3a1517-3a7f-40d0-a758-8ad02839eb5a 66184-440 HUMAN OTC DRUG ckone waterfresh face make up SPF 15 100 porcelain Titanium Dioxide CREAM TOPICAL 20120119 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 4.95; 2.4 mL/9.9g; mL/9.9g E 20171231 66184-445_710ff1f2-4f10-4f4e-9497-39f3aaafe9e3 66184-445 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 200 fair Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 4.95; 2.4 mL/9.9g; mL/9.9g E 20171231 66184-450_da022522-4d07-46e0-869d-d5549788ae6c 66184-450 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 300 sand Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 4.95; 2.4 mL/9.9g; mL/9.9g E 20171231 66184-455_ebc87358-cbe9-466f-be2d-0443203e7349 66184-455 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 350 beige Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 4.95; 2.4 mL/9.9g; mL/9.9g E 20171231 66184-460_b061a903-746b-4b5d-8077-010292c4ef43 66184-460 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 400 bisque Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 4.95; 2.4 mL/9.9g; mL/9.9g E 20171231 66184-465_af503a65-f996-485c-94f8-1d72ad56ec7e 66184-465 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 450 golden Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 4.95; 2.4 mL/9.9g; mL/9.9g E 20171231 66184-470_746cec21-9366-41e3-9799-3a712d1c3cc5 66184-470 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 500 tan Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 4.95; 2.4 mL/9.9g; mL/9.9g E 20171231 66184-475_2d916e0f-0dd1-416f-8f92-9d5186c2eca9 66184-475 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 600 honey Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 4.95; 2.4 mL/9.9g; mL/9.9g E 20171231 66184-480_eff07827-591e-423b-9a28-22fb6e0d0fc5 66184-480 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 700 caramel Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 4.95; 2.4 mL/9.9g; mL/9.9g E 20171231 66184-485_dd6b5d41-08a7-4cc1-bb2f-a786568256f4 66184-485 HUMAN OTC DRUG ck one waterfresh face makeup spf 15 800 cappucino Titanium Dioxide CREAM TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 4.95; 2.4 mL/9.9g; mL/9.9g E 20171231 66184-490_d6103ba2-6d63-4492-900e-50810f6d0b94 66184-490 HUMAN OTC DRUG ck one airlight pressed powder spf 15 porcelain 100 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g E 20171231 66184-495_8647421e-830c-4573-bbe3-3813fc3f2474 66184-495 HUMAN OTC DRUG ck one airlight pressed powder spf 15 fair 200 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g E 20171231 66184-500_33dd86e2-8c6c-407b-a4fa-d086bde8a648 66184-500 HUMAN OTC DRUG ck one airlight pressed powder spf 15 sand 300 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g E 20171231 66184-505_9d2457ac-3cf8-4942-8565-b1df6127ea94 66184-505 HUMAN OTC DRUG ck one airlight pressed powder spf 15 bisque 400 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g E 20171231 66184-510_f6cc5b60-ad4d-4a9e-92fe-2f382a569b25 66184-510 HUMAN OTC DRUG ck one airlight pressed powder spf 15 tan 500 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g E 20171231 66184-515_e58eb419-134e-4af1-b551-af66182a469d 66184-515 HUMAN OTC DRUG ck one airlight pressed powder spf 15 honey 600 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g E 20171231 66184-520_7394e4ce-11f4-49d4-a8df-6525d4981af8 66184-520 HUMAN OTC DRUG ck one airlight pressed powder spf 15 caramel 700 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g E 20171231 66184-525_d9e3549f-83ae-4785-8044-0f77a5e77a08 66184-525 HUMAN OTC DRUG ck one airlight pressed powder spf 15 cappuccino 700 Titanium Dioxide POWDER TOPICAL 20120124 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; ZINC OXIDE 1.475; 100 mg/10g; mg/10g E 20171231 66184-526_e31ae71d-f095-408b-a910-76633f993b19 66184-526 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 050 Ivory Titanium Dioxide and Octinoxate LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 1.648359; .999 g/30mL; g/30mL E 20171231 66184-527_7311bdc8-6e79-4ab7-8d17-09880f88ec6b 66184-527 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen Titanium Dioxide and Octinoxate LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 1.648359; .999 g/30mL; g/30mL E 20171231 66184-528_3be15f7f-21fa-4269-83a3-32e6484ebdee 66184-528 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 100 Porcelain Titanium Dioxide and Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 1.648359; .999 g/30mL; g/30mL E 20171231 66184-529_e0aa0900-284d-44b5-9a47-fa83fdc5e89c 66184-529 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 300 Sand Titanium Dioxide and Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 1.648359; .999 g/30mL; g/30mL E 20171231 66184-530_d46c2ef4-e883-4c59-9d81-b5260de37fa5 66184-530 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 350 Warm Sand Titanium Dioxide and Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 1.648359; .999 g/30mL; g/30mL E 20171231 66184-531_9f754fb4-d1ea-4e71-b13c-a181559a42b8 66184-531 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 400 Bisque Titanium Dioxide and Octinoxate LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 1.648359; .999 g/30mL; g/30mL E 20171231 66184-532_c1d7827a-aac0-415f-8862-39a4aee899c3 66184-532 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 500 Tan Titanium Dioxide and Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 1.648359; .999 g/30mL; g/30mL E 20171231 66184-533_0e06b90d-6afd-4120-9dbe-b2905e440b89 66184-533 HUMAN OTC DRUG ck one all day perfection face makeup spf 20 sunscreen 600 Honey Titanium Dioxide and Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Coty US LLC TITANIUM DIOXIDE; OCTINOXATE 1.648359; .999 g/30mL; g/30mL E 20171231 66213-200_284067bf-3b79-49ac-aae3-5a1cf182216d 66213-200 HUMAN PRESCRIPTION DRUG Compazine Prochlorperazine SUPPOSITORY RECTAL 20130701 ANDA ANDA040246 PBM Pharmaceuticals, Inc PROCHLORPERAZINE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 66213-421_03a3609f-520f-4e7b-8d7b-1652881723c0 66213-421 HUMAN PRESCRIPTION DRUG Donnatal Extentabs Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080507 UNAPPROVED DRUG OTHER PBM Pharmaceuticals, Inc PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 48.6; .3111; .0582; .0195 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 66213-422_09f51f78-ba70-4753-a0ae-9574cf22c9e0 66213-422 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL ELIXIR ELIXIR ORAL 20110701 UNAPPROVED DRUG OTHER PBM Pharmaceuticals Inc. PHENOBARBITAL; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; ATROPINE SULFATE 16.2; .1037; .0065; .0194 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 66213-422_fcbb3938-fca3-4ed6-96e4-446b7cdef5d6 66213-422 HUMAN PRESCRIPTION DRUG Donnatal phenobarbital elixir ELIXIR ORAL 20110701 UNAPPROVED DRUG OTHER PBM Pharmaceuticals Inc. PHENOBARBITAL; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; ATROPINE SULFATE 16.2; .1037; .0065; .0194 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 66213-423_5357c5a7-6413-4ece-9bde-c08763c19f50 66213-423 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL ELIXIR ELIXIR ORAL 20091101 UNAPPROVED DRUG OTHER PBM Pharmaceuticals Inc. PHENOBARBITAL; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; ATROPINE SULFATE 16.2; .1037; .0065; .0194 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 66213-423_f2607865-8e51-4fc8-a703-b9eb499f890d 66213-423 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL ELIXIR ELIXIR ORAL 20091101 UNAPPROVED DRUG OTHER PBM Pharmaceuticals Inc. PHENOBARBITAL; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; ATROPINE SULFATE 16.2; .1037; .0065; .0194 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 66213-425_05653083-535e-473b-bd53-e17df9ddc1dd 66213-425 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE TABLET ORAL 20080507 UNAPPROVED DRUG OTHER PBM Pharmaceuticals Inc. PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 66213-542_b4abec8b-4e5a-4374-bb05-bebd71523c96 66213-542 HUMAN PRESCRIPTION DRUG Animi-3 with Vitamin D Folic Acid, Cholecalciferol, Pyridoxine Hydrochloride, Cyanocobalamin, Omega-3 Fatty Acids, Doconexent, Icosapent CAPSULE ORAL 20110601 UNAPPROVED DRUG OTHER PBM Pharmaceuticals, Inc FOLIC ACID; CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; OMEGA-3 FATTY ACIDS; DOCONEXENT; ICOSAPENT; SOY STEROL 1; 1000; 12.5; 500; 500; 250; 35; 200 mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 66213-543_5e947d00-9af4-4632-bca3-e8b30ce39100 66213-543 HUMAN PRESCRIPTION DRUG Animi-3 Folic Acid, Cholecalciferol, Pyridoxine Hydrochloride, Cyanocobalamin, Omega-3 Fatty Acids, Doconexent, Icosapent, Phytosterols CAPSULE ORAL 20110601 UNAPPROVED DRUG OTHER PBM Pharmaceuticals, Inc FOLIC ACID; CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; OMEGA-3 FATTY ACIDS; DOCONEXENT; ICOSAPENT; SOY STEROL 1; 1000; 12.5; 500; 500; 250; 35; 200 mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 66215-001_d45c5594-3fa9-492d-89ea-4117ab4b592d 66215-001 HUMAN PRESCRIPTION DRUG Non-medicated VALCHLOR Demonstration Non-medicated VALCHLOR Demonstration GEL TOPICAL 20160113 NDA NDA202317 Actelion Pharmaceuticals US, Inc. E 20171231 66215-016_ae5a19e4-8f22-4616-ba92-b187d0cdbded 66215-016 HUMAN PRESCRIPTION DRUG VALCHLOR mechlorethamine hydrochloride GEL TOPICAL 20131021 NDA NDA202317 Actelion Pharmaceuticals US, Inc. MECHLORETHAMINE .012 g/60g Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 66215-101_1a1272e5-ee5e-4cf4-a45b-e1f68c28cd79 66215-101 HUMAN PRESCRIPTION DRUG Tracleer bosentan TABLET, FILM COATED ORAL 20011120 NDA NDA021290 Actelion Pharmaceuticals US, Inc. BOSENTAN 62.5 mg/1 Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 66215-102_1a1272e5-ee5e-4cf4-a45b-e1f68c28cd79 66215-102 HUMAN PRESCRIPTION DRUG Tracleer bosentan TABLET, FILM COATED ORAL 20011120 NDA NDA021290 Actelion Pharmaceuticals US, Inc. BOSENTAN 125 mg/1 Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 66215-103_1a1272e5-ee5e-4cf4-a45b-e1f68c28cd79 66215-103 HUMAN PRESCRIPTION DRUG Tracleer bosentan TABLET, SOLUBLE ORAL 20171113 NDA NDA209279 Actelion Pharmaceuticals US, Inc. BOSENTAN 32 mg/1 Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 66215-201_6ef1dcc7-f537-4552-9a57-95a45c6837c1 66215-201 HUMAN PRESCRIPTION DRUG Zavesca miglustat CAPSULE ORAL 20030731 NDA NDA021348 Actelion Pharmaceuticals US, Inc. MIGLUSTAT 100 mg/1 Glucosylceramide Synthase Inhibitor [EPC],Glucosylceramide Synthase Inhibitors [MoA] N 20181231 66215-302_956f55c2-83f5-4480-8315-87996bbc19b4 66215-302 HUMAN PRESCRIPTION DRUG Ventavis iloprost SOLUTION RESPIRATORY (INHALATION) 20050507 NDA NDA021779 Actelion Pharmaceuticals US, Inc. ILOPROST .01 mg/mL Prostacycline [EPC],Prostaglandins I [Chemical/Ingredient] N 20181231 66215-303_956f55c2-83f5-4480-8315-87996bbc19b4 66215-303 HUMAN PRESCRIPTION DRUG Ventavis iloprost SOLUTION RESPIRATORY (INHALATION) 20090824 NDA NDA021779 Actelion Pharmaceuticals US, Inc. ILOPROST .02 mg/mL Prostacycline [EPC],Prostaglandins I [Chemical/Ingredient] N 20181231 66215-402_22d2ee97-54b2-4a8d-9f7c-5d6dcd75e013 66215-402 HUMAN PRESCRIPTION DRUG Veletri epoprostenol INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100422 NDA NDA022260 Actelion Pharmaceuticals US, Inc. EPOPROSTENOL 1500000 ng/10mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 66215-403_22d2ee97-54b2-4a8d-9f7c-5d6dcd75e013 66215-403 HUMAN PRESCRIPTION DRUG Veletri epoprostenol INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20100422 NDA NDA022260 Actelion Pharmaceuticals US, Inc. EPOPROSTENOL 500000 ng/10mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 66215-501_92311667-1ffd-48bf-b01f-0a9262e16edb 66215-501 HUMAN PRESCRIPTION DRUG OPSUMIT macitentan TABLET, FILM COATED ORAL 20131104 NDA NDA204410 Actelion Pharmaceuticals US, Inc. MACITENTAN 10 mg/1 Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA] N 20181231 66215-602_5c9fb90f-f57a-401b-bc58-691593c07b4e 66215-602 HUMAN PRESCRIPTION DRUG UPTRAVI Selexipag TABLET, COATED ORAL 20151221 NDA NDA207947 Actelion Pharmaceuticals US, Inc. SELEXIPAG 200 ug/1 Prostacyclin Receptor Agonist [EPC],Prostacyclin Receptor Agonists [MoA] N 20191231 66215-604_5c9fb90f-f57a-401b-bc58-691593c07b4e 66215-604 HUMAN PRESCRIPTION DRUG UPTRAVI Selexipag TABLET, COATED ORAL 20151221 NDA NDA207947 Actelion Pharmaceuticals US, Inc. SELEXIPAG 400 ug/1 Prostacyclin Receptor Agonist [EPC],Prostacyclin Receptor Agonists [MoA] N 20191231 66215-606_5c9fb90f-f57a-401b-bc58-691593c07b4e 66215-606 HUMAN PRESCRIPTION DRUG UPTRAVI Selexipag TABLET, COATED ORAL 20151221 NDA NDA207947 Actelion Pharmaceuticals US, Inc. SELEXIPAG 600 ug/1 Prostacyclin Receptor Agonist [EPC],Prostacyclin Receptor Agonists [MoA] N 20191231 66215-608_5c9fb90f-f57a-401b-bc58-691593c07b4e 66215-608 HUMAN PRESCRIPTION DRUG UPTRAVI Selexipag TABLET, COATED ORAL 20151221 NDA NDA207947 Actelion Pharmaceuticals US, Inc. SELEXIPAG 800 ug/1 Prostacyclin Receptor Agonist [EPC],Prostacyclin Receptor Agonists [MoA] N 20191231 66215-610_5c9fb90f-f57a-401b-bc58-691593c07b4e 66215-610 HUMAN PRESCRIPTION DRUG UPTRAVI Selexipag TABLET, COATED ORAL 20151221 NDA NDA207947 Actelion Pharmaceuticals US, Inc. SELEXIPAG 1000 ug/1 Prostacyclin Receptor Agonist [EPC],Prostacyclin Receptor Agonists [MoA] N 20191231 66215-612_5c9fb90f-f57a-401b-bc58-691593c07b4e 66215-612 HUMAN PRESCRIPTION DRUG UPTRAVI Selexipag TABLET, COATED ORAL 20151221 NDA NDA207947 Actelion Pharmaceuticals US, Inc. SELEXIPAG 1200 ug/1 Prostacyclin Receptor Agonist [EPC],Prostacyclin Receptor Agonists [MoA] N 20191231 66215-614_5c9fb90f-f57a-401b-bc58-691593c07b4e 66215-614 HUMAN PRESCRIPTION DRUG UPTRAVI Selexipag TABLET, COATED ORAL 20151221 NDA NDA207947 Actelion Pharmaceuticals US, Inc. SELEXIPAG 1400 ug/1 Prostacyclin Receptor Agonist [EPC],Prostacyclin Receptor Agonists [MoA] N 20191231 66215-616_5c9fb90f-f57a-401b-bc58-691593c07b4e 66215-616 HUMAN PRESCRIPTION DRUG UPTRAVI Selexipag TABLET, COATED ORAL 20151221 NDA NDA207947 Actelion Pharmaceuticals US, Inc. SELEXIPAG 1600 ug/1 Prostacyclin Receptor Agonist [EPC],Prostacyclin Receptor Agonists [MoA] N 20191231 66215-628_5c9fb90f-f57a-401b-bc58-691593c07b4e 66215-628 HUMAN PRESCRIPTION DRUG UPTRAVI Titration Pack Selexipag KIT 20151221 NDA NDA207947 Actelion Pharmaceuticals US, Inc. N 20191231 66220-017_41df9cc3-ac17-4bea-9be5-80dd79e098ab 66220-017 HUMAN PRESCRIPTION DRUG Ethyol amifostine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160801 NDA NDA020221 Cumberland Pharmaceuticals Inc. AMIFOSTINE 500 mg/10mL Cytoprotective Agent [EPC],Free Radical Scavenging Activity [MoA] N 20181231 66220-110_25c418f4-00b5-471c-9473-e84fa740c4ea 66220-110 HUMAN PRESCRIPTION DRUG Totect dexrazoxane hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170725 NDA NDA022025 Cumberland Pharmaceuticals Inc. DEXRAZOXANE HYDROCHLORIDE 500 mg/1 Cytoprotective Agent [EPC] N 20181231 66220-160_55d8e04a-9757-4708-9ff0-827d686adc1d 66220-160 HUMAN PRESCRIPTION DRUG VAPRISOL DEXTROSE IN PLASTIC CONTAINER conivaptan hydrochloride INJECTION, SOLUTION INTRAVENOUS 20081008 NDA NDA021697 Cumberland Pharmaceuticals Inc. CONIVAPTAN HYDROCHLORIDE 20 mg/100mL Vasopressin Receptor Antagonists [MoA],Vasopressin Receptor Antagonist [EPC],Cytochrome P450 3A Inhibitors [MoA] N 20181231 66220-207_084c6cf6-84dc-41ee-b1f0-c7411c53a4e6 66220-207 HUMAN PRESCRIPTION DRUG ACETADOTE Acetylcysteine INJECTION, SOLUTION INTRAVENOUS 20040123 NDA NDA021539 Cumberland Pharmaceuticals Inc. ACETYLCYSTEINE 200 mg/mL Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] N 20181231 66220-287_70e66247-fb3f-4aa1-91e3-15669acb0cf8 66220-287 HUMAN PRESCRIPTION DRUG Caldolor ibuprofen INJECTION INTRAVENOUS 20090611 NDA NDA022348 Cumberland Pharmaceuticals Inc. IBUPROFEN 800 mg/8mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66220-422_2657d58c-687f-4b48-bc38-eab2b5f18c20 66220-422 HUMAN PRESCRIPTION DRUG Omeclamox-Pak omeprazole, clarithromycin, amoxicillin KIT 20120427 NDA NDA050824 Cumberland Pharmaceuticals Inc. N 20181231 66220-719_345383dc-2e49-462c-b304-d49c3be6783e 66220-719 HUMAN PRESCRIPTION DRUG Kristalose lactulose POWDER, FOR SOLUTION ORAL 20120120 ANDA ANDA074712 Cumberland Pharmaceuticals Inc. LACTULOSE 10 g/10g Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 66220-729_345383dc-2e49-462c-b304-d49c3be6783e 66220-729 HUMAN PRESCRIPTION DRUG Kristalose lactulose POWDER, FOR SOLUTION ORAL 20120120 ANDA ANDA074712 Cumberland Pharmaceuticals Inc. LACTULOSE 20 g/20g Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 66222-0001_f9ed7960-4a85-45aa-8e48-68c9991e93d7 66222-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010209 UNAPPROVED MEDICAL GAS JCMH Home Health Products OXYGEN 99 L/100L E 20171231 66228-001_0a1c0cfb-72a8-4f68-a810-90220c420083 66228-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19910401 NDA NDA206023 CLAY COUNTY HOSPITAL DME OXYGEN 990 1/L N 20181231 66233-711_2cff45d1-c9a8-2f6e-e054-00144ff88e88 66233-711 HUMAN OTC DRUG Menastil calendula officinalis flowering top OIL TOPICAL 20010704 UNAPPROVED HOMEOPATHIC Atlantic Management Resources Inc CALENDULA OFFICINALIS FLOWERING TOP .0025 g/g E 20171231 66233-712_2cb44058-9eb2-45b2-e054-00144ff88e88 66233-712 HUMAN OTC DRUG Neuroquell Neuroquell OIL TOPICAL 20010704 UNAPPROVED HOMEOPATHIC Atlantic Management Resources Inc CALENDULA OFFICINALIS FLOWERING TOP .005 g/g E 20171231 66233-713_2bfdbab3-9a83-3c2f-e054-00144ff88e88 66233-713 HUMAN OTC DRUG ProSirona Calendula Oficinalis Flowering Top OIL TOPICAL 20010704 UNAPPROVED HOMEOPATHIC Atlantic Management Resources Inc. CALENDULA OFFICINALIS FLOWERING TOP .0035 g/g E 20171231 66233-714_2bfe28d5-e9ba-4689-e054-00144ff88e88 66233-714 HUMAN OTC DRUG Neuroquell-Plus Neuroquell-Plus OIL TOPICAL 20040705 UNAPPROVED HOMEOPATHIC Atlantic Management Resources Inc CALENDULA OFFICINALIS FLOWERING TOP .015 g/g E 20171231 66259-424_a2b1aa3d-bc1d-4cc5-af21-703e7abd6df4 66259-424 HUMAN PRESCRIPTION DRUG Indocyanine green Indocyanine green INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20151201 ANDA ANDA040811 Novadaq Technologies Inc. INDOCYANINE GREEN 25 mg/1 N 20181231 66259-701_b346daf5-b33e-4d8f-b031-f8bc34c0e1dd 66259-701 HUMAN PRESCRIPTION DRUG IC-Green Indocyanine Green INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130925 NDA NDA011525 Novadaq Technologies Inc. INDOCYANINE GREEN 25 mg/1 N 20181231 66267-001_3b65ccb4-dd59-7495-e054-00144ff88e88 66267-001 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 NuCare Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 66267-003_3ca30e22-44a4-543e-e054-00144ff8d46c 66267-003 HUMAN OTC DRUG Regular Strength Pain Relief Acetaminophen TABLET ORAL 20160916 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals, Inc. ACETAMINOPHEN 325 mg/1 N 20181231 66267-005_3d06cd15-7ddb-52f9-e054-00144ff8d46c 66267-005 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 20160921 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 66267-007_5782a8f4-3b59-d45e-e053-2a91aa0ae8d3 66267-007 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 NuCare Pharmaceuticals,Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 66267-013_3d0821cd-c842-13b9-e054-00144ff8d46c 66267-013 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20160921 ANDA ANDA074112 NuCare Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-014_3c8ff83a-3978-6856-e054-00144ff88e88 66267-014 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 NuCare Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-018_3d0ad12e-3953-2cec-e054-00144ff88e88 66267-018 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160921 ANDA ANDA202446 NuCare Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 66267-019_3d6ba62c-7983-274e-e054-00144ff88e88 66267-019 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 NuCare Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 66267-020_3c16dbce-4673-1ef2-e054-00144ff8d46c 66267-020 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 NuCare Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 66267-021_3d6ca44b-9068-4503-e054-00144ff88e88 66267-021 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NuCare Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-022_3d6cf1b3-f1dd-4eab-e054-00144ff88e88 66267-022 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, CHEWABLE ORAL 19930101 ANDA ANDA064013 NuCare Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-023_3d6d940d-9c60-16c7-e054-00144ff8d46c 66267-023 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NuCare Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-025_3d6f33d8-3fd3-268d-e054-00144ff88e88 66267-025 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19880225 ANDA ANDA062882 NuCare Pharmaceuticals, Inc. AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-026_3d93b9cd-73ca-4385-e054-00144ff88e88 66267-026 HUMAN OTC DRUG Regular Strength Enteric coated aspirin Aspirin TABLET, COATED ORAL 20000701 OTC MONOGRAPH FINAL part343 NuCare Pharmaceuticals, Inc. ASPIRIN 325 mg/1 N 20181231 66267-029_3d70576a-6fa8-481d-e054-00144ff88e88 66267-029 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 NuCare Pharmaceuticals, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 66267-030_3d7eb118-fa56-4efd-e054-00144ff88e88 66267-030 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 NuCare Pharmaceuticals, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 66267-031_3d7fd509-74e6-73e8-e054-00144ff88e88 66267-031 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 NuCare Pharmaceuticals, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 66267-033_3d80f2d7-b516-2951-e054-00144ff8d46c 66267-033 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070904 ANDA ANDA040597 NuCare Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 66267-039_3d842708-32b4-18c8-e054-00144ff88e88 66267-039 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 19870121 ANDA ANDA089175 NuCare Pharmaceuticals, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 66267-040_3d94d670-3686-63b5-e054-00144ff88e88 66267-040 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 NuCare Pharmaceuticals, Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 66267-043_3d95674d-5202-095c-e054-00144ff88e88 66267-043 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20100701 ANDA ANDA040823 NuCare Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 66267-045_3d956fea-c4e8-08c5-e054-00144ff88e88 66267-045 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080423 ANDA ANDA065392 NuCare Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66267-049_3d963dd7-f780-17ce-e054-00144ff88e88 66267-049 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20071212 ANDA ANDA065248 NuCare Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66267-050_3d94f978-7050-5c09-e054-00144ff8d46c 66267-050 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20080118 ANDA ANDA065248 NuCare Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66267-051_3d95bbc1-cd7f-0eb4-e054-00144ff88e88 66267-051 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760702 ANDA ANDA084769 NuCare Pharmaceuticals, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-055_3d958dea-aeb4-1ef7-e054-00144ff8d46c 66267-055 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20110822 ANDA ANDA089859 NuCare Pharmaceuticals, Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 66267-057_3d958dea-af1b-1ef7-e054-00144ff8d46c 66267-057 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20040202 ANDA ANDA074151 NuCare Pharmaceuticals, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 66267-060_3d963242-a7b4-1ea4-e054-00144ff88e88 66267-060 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 NuCare Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 66267-061_3d963dd7-f79f-17ce-e054-00144ff88e88 66267-061 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 NuCare Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 66267-062_3e0c4b95-eb02-2465-e054-00144ff88e88 66267-062 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 NuCare Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 66267-064_3d966e77-9332-4051-e054-00144ff8d46c 66267-064 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 ANDA ANDA090478 NuCare Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 66267-067_3d96ddeb-71e3-5fa6-e054-00144ff8d46c 66267-067 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088238 NuCare Pharmaceuticals, Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66267-068_3d96b227-d3a6-4c8c-e054-00144ff8d46c 66267-068 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 NuCare Pharmaceuticals, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-069_3d97af6e-d53c-50ac-e054-00144ff88e88 66267-069 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071135 NuCare Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-070_3da9e463-1b30-54c0-e054-00144ff88e88 66267-070 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19980811 ANDA ANDA075219 NuCare Pharmaceuticals, Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-071_62edf474-9c17-d535-e053-2991aa0a4a09 66267-071 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 NuCare Pharmaceuticals,Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 66267-073_3dbcccb5-5a37-45cf-e054-00144ff8d46c 66267-073 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19900930 ANDA ANDA062286 NuCare Pharmaceticals, Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-074_3dbce2c5-aaf7-1c9f-e054-00144ff88e88 66267-074 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19990226 ANDA ANDA040230 NuCare Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 66267-076_3dbd6d99-b487-5cf2-e054-00144ff8d46c 66267-076 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 19590806 NDA NDA011722 NuCare Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 66267-077_3dbd8bee-1278-301e-e054-00144ff88e88 66267-077 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 19601117 NDA NDA012546 NuCare Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 66267-078_3dbd8baa-fe22-5197-e054-00144ff8d46c 66267-078 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20140114 NDA AUTHORIZED GENERIC NDA020405 NuCare Pharmaceuticals, Inc. DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 66267-080_3dbdf67f-766c-12ee-e054-00144ff8d46c 66267-080 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 NuCare Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 66267-081_3dbdf020-ca18-1197-e054-00144ff8d46c 66267-081 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 NuCare Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 66267-082_3dbdf020-ca19-1197-e054-00144ff8d46c 66267-082 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 NuCare Pharmaceuticals, Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 66267-083_3dbe7c44-2c9f-5245-e054-00144ff88e88 66267-083 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 NuCare Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 66267-085_3dbe7c02-afc3-53dd-e054-00144ff88e88 66267-085 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 NuCare Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 66267-092_3dbf062b-4375-3542-e054-00144ff8d46c 66267-092 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 NuCare Pharmaceuticals, Inc ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 66267-093_3dc07936-7971-1380-e054-00144ff8d46c 66267-093 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 NuCare Pharmaceuticals, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 66267-095_3dc0dc77-6305-2af8-e054-00144ff8d46c 66267-095 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20030501 ANDA ANDA076004 NuCare Pharmaceuticals, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-099_3e295cbc-37c2-4e25-e054-00144ff8d46c 66267-099 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 NuCare Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 66267-100_3e344556-2472-1067-e054-00144ff8d46c 66267-100 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 NuCare Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 66267-102_3e351a7e-7ce3-441b-e054-00144ff88e88 66267-102 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 NuCare Pharmaceuticals, Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 66267-103_3e354b4d-70e5-5089-e054-00144ff88e88 66267-103 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 NuCare Pharmaceuticals, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 66267-106_3e35a56a-2dc0-5938-e054-00144ff88e88 66267-106 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 NuCare Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 66267-107_3e36a5bf-63c8-22a9-e054-00144ff8d46c 66267-107 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 NuCare Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 66267-112_3e36fbbc-2a2a-15ec-e054-00144ff88e88 66267-112 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 NuCare Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 66267-113_513a3fa4-8f4e-23bb-e054-00144ff88e88 66267-113 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 NuCare Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 66267-114_3e37cdfa-e069-5c20-e054-00144ff8d46c 66267-114 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 NuCare Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 66267-115_3e3848f2-4923-39ea-e054-00144ff88e88 66267-115 HUMAN OTC DRUG Ibuprofen ibuprofen TABLET, FILM COATED ORAL 20040101 ANDA ANDA075010 NuCare Pharmaceuticals, Inc. IBUPROFEN 200 mg/1 N 20181231 66267-116_3e49321c-a470-1fdf-e054-00144ff88e88 66267-116 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 NuCare Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-117_3e8721e8-f400-2201-e054-00144ff8d46c 66267-117 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 NuCare Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-118_3e86fd0b-4627-580c-e054-00144ff88e88 66267-118 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 NuCare Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-119_3e8796a6-94c7-0db2-e054-00144ff88e88 66267-119 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 NuCare Pharmaceuticals, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-120_3e87e34a-6557-4b0f-e054-00144ff8d46c 66267-120 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 NuCare Pharmaceuticals, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-121_3e88092d-15d7-1744-e054-00144ff88e88 66267-121 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20101206 ANDA ANDA091549 NuCare Pharmaceuticals, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-124_3e8846de-b68c-22da-e054-00144ff88e88 66267-124 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 NuCare Pharmaceuticals, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 66267-126_3e895349-537f-1b35-e054-00144ff8d46c 66267-126 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 19930101 ANDA ANDA073517 NuCare Pharmaceuticals, Inc. KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-130_60dc9a95-b828-30d2-e053-2991aa0a409a 66267-130 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 NuCare Pharmaceuticals,Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 66267-131_60cb3375-8109-7dc7-e053-2a91aa0a6ccd 66267-131 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 NuCare Pharmaceuticals,Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 66267-132_61691f99-73ef-e897-e053-2991aa0a3411 66267-132 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 NuCare Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 66267-133_3e8a193e-fc8a-2a9f-e054-00144ff8d46c 66267-133 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 NuCare Pharmaceuticals, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-138_3e898141-8d68-49f1-e054-00144ff88e88 66267-138 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 NuCare Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 66267-139_3e88f3a3-76c1-3717-e054-00144ff88e88 66267-139 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 NuCare Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 66267-140_3e88f3a3-76cb-3717-e054-00144ff88e88 66267-140 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 NuCare Pharmaceuticals, Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 66267-145_3e88ecc9-598b-08fb-e054-00144ff8d46c 66267-145 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 NuCare Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 66267-146_3e89a426-c742-2f44-e054-00144ff8d46c 66267-146 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 NuCare Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 66267-147_3e8a4af0-c729-61d2-e054-00144ff88e88 66267-147 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131216 ANDA ANDA079067 NuCare Pharmaceuticlas, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 66267-148_3e8ab34e-9579-6dc1-e054-00144ff88e88 66267-148 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131216 ANDA ANDA079067 NuCare Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 66267-151_3e8acae6-a87e-678b-e054-00144ff8d46c 66267-151 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 NuCare Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-152_3e8ba309-9747-64d1-e054-00144ff8d46c 66267-152 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 NuCare Pharmaceuticals, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-153_3e8bcc59-dab2-1b4c-e054-00144ff88e88 66267-153 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 NuCare Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-154_3e8bbec1-1b1a-1809-e054-00144ff88e88 66267-154 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 NuCare Pharmaceuticals, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-156_3eb172aa-4f31-66df-e054-00144ff88e88 66267-156 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 NuCare Pharmaceuticals, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 66267-158_3eb1b1cc-ed7b-6f0f-e054-00144ff88e88 66267-158 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 NuCare Pharmaceuticals, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 66267-159_4af2a165-0b9d-2539-e054-00144ff8d46c 66267-159 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NuCare Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-160_3eb1de07-b7d1-4003-e054-00144ff8d46c 66267-160 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NuCare Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-161_3eb1b1cc-edbd-6f0f-e054-00144ff88e88 66267-161 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20110818 UNAPPROVED DRUG OTHER NuCare Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 66267-162_3eb2170f-372b-02d5-e054-00144ff88e88 66267-162 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl 200mg Phenazopyridine Hydrochloride TABLET ORAL 20141231 UNAPPROVED DRUG OTHER NuCare Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 66267-166_3eb22c54-9581-089b-e054-00144ff88e88 66267-166 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20130812 ANDA ANDA040526 NuCare Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 66267-167_3eb365f6-896f-2efe-e054-00144ff88e88 66267-167 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 NuCare Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 66267-171_63106192-35d6-6989-e053-2991aa0aa714 66267-171 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 NuCare Pharmaceuticals,Inc. PREDNISONE 10 mg/1 N 20191231 66267-172_63102d75-9b2c-84a9-e053-2a91aa0a317d 66267-172 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 NuCare Pharmaceuticals,Inc. PREDNISONE 5 mg/1 N 20191231 66267-173_63745821-055c-7033-e053-2a91aa0a554c 66267-173 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 NuCare Pharmaceuticals,Inc. PREDNISONE 5 mg/1 N 20191231 66267-176_63264765-9ae5-286c-e053-2a91aa0ad0a9 66267-176 HUMAN PRESCRIPTION DRUG Prochlorperazine Prochlorperazine SUPPOSITORY RECTAL 19931130 ANDA ANDA040058 NuCare Pharmaceuticals,Inc. PROCHLORPERAZINE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 66267-177_3ec1f92b-4259-37fc-e054-00144ff88e88 66267-177 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 NuCare Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 66267-180_48acf0ed-7ec1-0d2a-e054-00144ff88e88 66267-180 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070218 NuCare Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 66267-181_3b74da89-12b8-4c1c-e054-00144ff8d46c 66267-181 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070219 NuCare Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 66267-188_3ed6c98a-1300-1e8d-e054-00144ff88e88 66267-188 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 NuCare Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 66267-196_3ed6aba6-abb1-1797-e054-00144ff88e88 66267-196 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 NuCare Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 66267-205_3f1365ac-9aaf-4147-e054-00144ff8d46c 66267-205 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 NuCare Pharmaceuticals, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 66267-207_61438d1f-2379-2748-e053-2991aa0a6198 66267-207 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20090921 ANDA ANDA071251 NuCare Pharmaceuticals,Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 66267-211_3f143af0-4211-08f1-e054-00144ff8d46c 66267-211 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140129 ANDA ANDA074587 NuCare Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 66267-212_3f14442c-8179-0bad-e054-00144ff8d46c 66267-212 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090917 ANDA ANDA078906 NuCare Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 66267-217_5784aae8-20fc-2bf5-e053-2a91aa0a95bd 66267-217 HUMAN PRESCRIPTION DRUG Folic Acid FOLIC ACID TABLET ORAL 20090112 ANDA ANDA040796 NuCare Pharmaceuticals, Inc. FOLIC ACID 1 mg/1 N 20181231 66267-219_3f14a94b-0c4a-1fec-e054-00144ff8d46c 66267-219 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 NuCare Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-224_3f14a94b-0c6f-1fec-e054-00144ff8d46c 66267-224 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20150429 ANDA ANDA203154 NuCare Pharmaceuticals, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 66267-240_406956f5-b89b-5b30-e054-00144ff8d46c 66267-240 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 NuCare Pharmaceuticals, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 66267-259_40ba25e2-981e-3454-e054-00144ff8d46c 66267-259 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110222 NDA AUTHORIZED GENERIC NDA018279 NuCare Pharmaceuticals, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 66267-268_40ba9945-5941-0b69-e054-00144ff88e88 66267-268 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150407 ANDA ANDA040616 NuCare Pharmaceuticals, Inc WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 66267-271_40bd3a0c-3690-64e9-e054-00144ff88e88 66267-271 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 19980301 ANDA ANDA040268 NuCare Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 66267-277_40bd3462-480d-5f95-e054-00144ff88e88 66267-277 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150609 ANDA ANDA040616 NuCare Pharmaceuticals, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 66267-278_40cdc43d-72db-6a9e-e054-00144ff8d46c 66267-278 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20091023 ANDA ANDA077272 NuCare Pharmaceuticals, Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 66267-285_40ce8b53-0f2b-1f38-e054-00144ff8d46c 66267-285 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 NuCare Pharmaceuticals, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 66267-286_40cf021d-5f2b-055c-e054-00144ff88e88 66267-286 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 NuCare Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 66267-287_40d12c65-394a-5127-e054-00144ff88e88 66267-287 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA073449 NuCare Pharmaceuticals, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 66267-291_40e21575-3210-2ac6-e054-00144ff88e88 66267-291 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 NuCare Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 66267-294_40e2f725-1bd9-4652-e054-00144ff88e88 66267-294 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20110107 ANDA ANDA071881 NuCare Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 66267-305_40e2fa93-f061-681d-e054-00144ff8d46c 66267-305 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20161109 ANDA ANDA078888 NuCare Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 66267-321_62fc08cd-8144-1652-e053-2a91aa0ad7ed 66267-321 HUMAN PRESCRIPTION DRUG temazepam temazepam CIV CAPSULE ORAL 19870421 ANDA ANDA071457 NuCare Pharmaceuticals,Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20191231 66267-322_40e38f84-301c-0e9b-e054-00144ff8d46c 66267-322 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 NuCare Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 66267-323_3b7743da-5975-6b5f-e054-00144ff88e88 66267-323 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NuCare Pharmaceuticals, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 66267-325_40e377ec-fec3-0963-e054-00144ff8d46c 66267-325 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 NuCare Pharmaceuticals, Inc. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 66267-343_40e38f84-2fcc-0e9b-e054-00144ff8d46c 66267-343 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20140411 ANDA ANDA074661 NuCare Pharmaceuticals, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 66267-346_40e3b957-d857-5a66-e054-00144ff88e88 66267-346 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 NuCare Pharmaceuticals, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 66267-357_40e36e10-f834-04c0-e054-00144ff8d46c 66267-357 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20031023 ANDA ANDA040525 NuCare Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 66267-358_40e440ba-299f-6f14-e054-00144ff88e88 66267-358 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 NuCare Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-373_5e873524-f9fc-fe2d-e053-2991aa0aa0a5 66267-373 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20160705 ANDA ANDA091432 NuCare Pharmaceuticals,Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-377_40e467df-913a-38ab-e054-00144ff8d46c 66267-377 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150422 ANDA ANDA202824 NuCare Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 66267-378_40e467df-9171-38ab-e054-00144ff8d46c 66267-378 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150422 ANDA ANDA202824 NuCare Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 66267-380_40e599a4-6d31-03d5-e054-00144ff8d46c 66267-380 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NuCare Pharmaceuticals, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 66267-389_40e5ae44-708b-15a3-e054-00144ff8d46c 66267-389 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 NuCare Pharmaceuticals, Inc. TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 66267-392_4b3293d6-3f0c-1948-e054-00144ff88e88 66267-392 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072192 NuCare Pharmaceuticals, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 66267-394_40e5cc54-ed71-3369-e054-00144ff88e88 66267-394 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 NuCare Pharmaceuticals, Inc, PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 66267-399_40e5cc54-ed75-3369-e054-00144ff88e88 66267-399 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 NuCare Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 66267-413_40e63004-7929-4099-e054-00144ff88e88 66267-413 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NuCare Pharmaceuticals, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 66267-415_575f2b75-90ec-5d17-e053-2a91aa0a44b9 66267-415 HUMAN PRESCRIPTION DRUG temazepam temazepam CIV CAPSULE ORAL 19870421 ANDA ANDA071456 NuCare Pharmaceuticals,Inc. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 66267-416_415e373b-4756-1399-e054-00144ff8d46c 66267-416 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 NuCare Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 66267-418_415a816c-ede6-390d-e054-00144ff8d46c 66267-418 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 NuCare Pharmaceuticals, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 66267-418_5551e0df-e642-08c9-e054-00144ff88e88 66267-418 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 NuCare Pharmaceuticals,Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 66267-427_415b7866-a5db-58fb-e054-00144ff8d46c 66267-427 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 NuCare Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-430_415ac7e0-ddb5-453e-e054-00144ff8d46c 66267-430 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150422 ANDA ANDA202824 NuCare Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 66267-436_415a5393-2970-30e3-e054-00144ff8d46c 66267-436 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20160708 ANDA ANDA077836 NuCare Pharmaceuticals, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 66267-443_415b168c-1220-2777-e054-00144ff88e88 66267-443 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20140114 NDA AUTHORIZED GENERIC NDA020405 NuCare Pharmaceuticals, Inc. DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 66267-452_415b2626-8589-0fd4-e054-00144ff88e88 66267-452 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 NuCare Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 66267-464_415b168c-1268-2777-e054-00144ff88e88 66267-464 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 NuCare Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 66267-476_415b3da7-3fdb-4a5f-e054-00144ff8d46c 66267-476 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 19860723 ANDA ANDA089424 NuCare Pharmaceuticals, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 66267-482_415b168c-12c3-2777-e054-00144ff88e88 66267-482 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 NuCare Pharmaceuticals, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-482_55284fef-d3a3-1f86-e054-00144ff8d46c 66267-482 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 NuCare Pharmaceuticals,Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-483_415b2626-8610-0fd4-e054-00144ff88e88 66267-483 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073553 NuCare Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 66267-484_415b3da7-3ffc-4a5f-e054-00144ff8d46c 66267-484 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073554 NuCare Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 66267-488_56315180-e0c5-46c2-e054-00144ff88e88 66267-488 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 NuCare Pharmaceuticals,Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 66267-493_415b9b54-d862-6aeb-e054-00144ff8d46c 66267-493 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20020129 ANDA ANDA075967 NuCare Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 66267-497_57477dd9-49d4-b1e3-e053-2a91aa0a5741 66267-497 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 NuCare Pharmaceuticals,Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 66267-499_415c74b0-cdba-54bc-e054-00144ff88e88 66267-499 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 NuCare Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 66267-506_415c8774-a1f8-1e48-e054-00144ff8d46c 66267-506 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 NuCare Pharmaceuticals, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 66267-508_415c63d4-5875-532f-e054-00144ff88e88 66267-508 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 NuCare Pharmaceuticals, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 66267-510_415c2698-7796-49f8-e054-00144ff88e88 66267-510 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20111212 ANDA ANDA201407 NuCare Pharmaceuticals, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 66267-528_415dd0ac-aa5b-11e9-e054-00144ff88e88 66267-528 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 NuCare Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 66267-529_415dd0ac-aaa0-11e9-e054-00144ff88e88 66267-529 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 NuCare Pharmaceuticals, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-543_415ddb02-f0aa-04a0-e054-00144ff8d46c 66267-543 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 NuCare Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 66267-549_44432654-feaa-0c64-e054-00144ff8d46c 66267-549 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 NuCare Pharmaceuticals, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-553_63773694-0bfe-f3a2-e053-2a91aa0a4d5b 66267-553 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 NuCare Pharmaceuticals,Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 66267-555_444409d1-8f09-14f3-e054-00144ff88e88 66267-555 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 NuCare Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 66267-561_4444573e-9df2-01e6-e054-00144ff8d46c 66267-561 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 NuCare Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 66267-563_44564663-40c3-27fe-e054-00144ff8d46c 66267-563 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 NuCare Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 66267-564_60bae0fe-06b9-45ae-e053-2a91aa0adeb2 66267-564 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19980325 ANDA ANDA074909 NuCare Pharmaceuticals,Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-570_44559247-918b-0de2-e054-00144ff8d46c 66267-570 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 NuCare Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 66267-576_4b7d32de-78cd-0a64-e054-00144ff8d46c 66267-576 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 NuCare Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 66267-577_44571f77-6b6d-3885-e054-00144ff88e88 66267-577 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160425 ANDA ANDA202554 NuCare Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 66267-578_44571f77-6bb1-3885-e054-00144ff88e88 66267-578 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160602 ANDA ANDA202554 NuCare Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 66267-583_4457c3e6-a39e-4aae-e054-00144ff88e88 66267-583 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150609 ANDA ANDA075994 NuCare Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 66267-587_50490db4-9711-6d7e-e054-00144ff88e88 66267-587 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20150730 ANDA ANDA204597 NuCarePharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 66267-588_44a95264-6285-0c77-e054-00144ff8d46c 66267-588 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 NuCare Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 66267-596_44ab9815-39f5-1463-e054-00144ff8d46c 66267-596 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 19961111 ANDA ANDA070848 NuCare Pharmaceuticals, Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 66267-598_4acbfbc3-33eb-32cf-e054-00144ff8d46c 66267-598 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 NuCare Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 66267-608_44ac182e-f8e0-3974-e054-00144ff88e88 66267-608 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070108 ANDA ANDA071141 NuCare Pharmaceuticals, Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-614_44ac37eb-d6cf-3a6f-e054-00144ff8d46c 66267-614 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 NuCare Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 66267-617_44bb1b0d-6f1f-32f5-e054-00144ff8d46c 66267-617 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20070701 ANDA ANDA078220 NuCare Pharmaceuticals, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 66267-648_44bc14be-b9dd-60ce-e054-00144ff88e88 66267-648 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 NuCare Pharmaceuticals, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 66267-649_44bbe727-ed75-5800-e054-00144ff88e88 66267-649 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20081028 ANDA ANDA078536 NuCare Pharmaceuticals, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 66267-653_54b37bcc-a8b1-0c17-e054-00144ff8d46c 66267-653 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 NuCare Pharmaceuticals,Inc. LORATADINE 10 mg/1 N 20181231 66267-665_44bcc8df-a804-010f-e054-00144ff88e88 66267-665 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20150429 ANDA ANDA203154 NuCare Pharmaceuticals, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 66267-672_4be38281-59e3-2495-e054-00144ff8d46c 66267-672 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150714 ANDA ANDA040616 NuCare Pharmaceuticals, Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 66267-676_44be9837-f156-09f2-e054-00144ff8d46c 66267-676 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 NuCare Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 66267-681_44bebbee-92ec-4420-e054-00144ff88e88 66267-681 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 NuCare Pharmaceuticals, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 66267-684_44beef38-63c6-1c64-e054-00144ff8d46c 66267-684 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 NuCare Pharmaceuticals, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 66267-700_5bad0749-c5a9-ba85-e053-2991aa0ab955 66267-700 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 NuCare Pharmaceuticals,Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 66267-708_4fc03547-1b71-4f43-e054-00144ff88e88 66267-708 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 NuCare Pharmaceuticals, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-709_44bf912b-231b-5e37-e054-00144ff88e88 66267-709 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021106 ANDA ANDA076201 NuCare Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-710_44d3967f-cf98-6bdf-e054-00144ff8d46c 66267-710 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 19990610 ANDA ANDA075191 NuCare Pharmaceuticals, Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 66267-712_44e4b025-4965-0225-e054-00144ff88e88 66267-712 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 NuCare Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 66267-716_59cdc8b2-eb1f-1c5b-e053-2a91aa0abe9d 66267-716 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 NuCare Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 66267-721_63ef981d-16b8-08c7-e053-2991aa0a0868 66267-721 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 NuCare Pharmaceuticals,Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 66267-734_4533f8ff-8c4b-596d-e054-00144ff8d46c 66267-734 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 NuCare Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 66267-746_3b7837fa-2f4c-0ffc-e054-00144ff88e88 66267-746 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 Nucare Pharmaceuticals, Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 66267-748_4be6ce23-e774-510e-e054-00144ff8d46c 66267-748 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 Nu Care Pharmaceuticals, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-749_4533bca1-0cb9-157f-e054-00144ff88e88 66267-749 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20031211 ANDA ANDA076416 NuCare Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 66267-751_4533ad6f-eca7-4526-e054-00144ff8d46c 66267-751 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 NuCare Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 66267-752_45348a08-55c8-01d8-e054-00144ff8d46c 66267-752 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 NuCare Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 66267-759_636063b7-797e-2de5-e053-2a91aa0a5f2c 66267-759 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 NuCare Pharmaceuticals,Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 66267-760_4be7a143-df58-0f39-e054-00144ff88e88 66267-760 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 NuCare Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-760_540e9b7e-09ea-2cca-e054-00144ff8d46c 66267-760 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 NuCare Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-763_4534c7a7-bc3b-3851-e054-00144ff88e88 66267-763 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 NuCare Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-764_45358382-9ffa-2c6b-e054-00144ff8d46c 66267-764 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NuCare Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-765_45389641-b70d-5bc9-e054-00144ff8d46c 66267-765 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070409 ANDA ANDA040597 NuCare Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 66267-767_4870d598-4250-4e28-e054-00144ff8d46c 66267-767 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 NuCare Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 66267-768_454812f2-8ea5-660d-e054-00144ff88e88 66267-768 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070125 ANDA ANDA065352 NuCare Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66267-769_4548190f-d547-67a1-e054-00144ff88e88 66267-769 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20071212 ANDA ANDA065248 NuCare Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66267-770_4548a932-bc0f-37a8-e054-00144ff8d46c 66267-770 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20080118 ANDA ANDA065248 NuCare Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66267-771_4896cbd1-57d9-1fc6-e054-00144ff8d46c 66267-771 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 19760701 ANDA ANDA084769 NuCare Pharmaceuticals, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-774_4548773f-520e-1ca8-e054-00144ff8d46c 66267-774 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 NuCare Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 66267-775_63759b18-1e21-6227-e053-2a91aa0a77fa 66267-775 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 ANDA ANDA090478 NuCare Pharmaceuticals,Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 66267-776_46db10b7-535a-17c0-e054-00144ff8d46c 66267-776 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071135 NuCare Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-778_46db4878-c9dc-0c69-e054-00144ff88e88 66267-778 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20070524 OTC MONOGRAPH FINAL part341 NuCare Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 66267-779_489645ad-d7db-5f52-e054-00144ff8d46c 66267-779 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 NuCare Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 66267-780_4870a6db-8a16-3a11-e054-00144ff88e88 66267-780 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 NuCare Pharmaceuticals, Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 66267-781_46dba0e3-d6c4-1d68-e054-00144ff88e88 66267-781 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 NuCare Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 66267-792_46dbb362-01a4-1e3e-e054-00144ff88e88 66267-792 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 NuCare Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 66267-793_46dc1bb6-d21a-4c86-e054-00144ff8d46c 66267-793 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 NuCare Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-795_47697399-c99c-5e68-e054-00144ff88e88 66267-795 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 NuCare Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-797_5798bccc-7347-f097-e053-2991aa0a24f8 66267-797 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 NuCare Pharmaceuticals,Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 66267-798_46dc8f62-e703-50e3-e054-00144ff8d46c 66267-798 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 NuCare Pharmaceuticals, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-800_46dc0641-dfa7-4819-e054-00144ff8d46c 66267-800 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 NuCare Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 66267-801_46dcd9a1-b55c-3809-e054-00144ff88e88 66267-801 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 NuCare Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 66267-804_46dcd9a1-b55d-3809-e054-00144ff88e88 66267-804 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131216 ANDA ANDA079067 NuCare Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 66267-805_46dcdd52-cec2-62ce-e054-00144ff8d46c 66267-805 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131216 ANDA ANDA079067 NuCare Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 66267-806_46dd3ba1-663f-0bfb-e054-00144ff8d46c 66267-806 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 NuCare Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-807_46dd3908-6fec-4f50-e054-00144ff88e88 66267-807 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 NuCare Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-808_46dc1bb6-d1e2-4c86-e054-00144ff8d46c 66267-808 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NuCare Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-809_46dc1bb6-d231-4c86-e054-00144ff8d46c 66267-809 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 NuCare Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-810_46dc1bb6-d234-4c86-e054-00144ff8d46c 66267-810 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl 100mg Phenazopyridine Hydrochloride TABLET ORAL 20141231 UNAPPROVED DRUG OTHER NuCare Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 66267-811_57fcd577-9473-4cee-e053-2991aa0a266b 66267-811 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl 200mg Phenazopyridine Hydrochloride TABLET ORAL 20141231 UNAPPROVED DRUG OTHER NuCare Pharmaceuticals,Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 66267-812_62eca5b4-18dc-c606-e053-2a91aa0af1f3 66267-812 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 NuCare Pharmaceuticals,Inc. PREDNISONE 10 mg/1 N 20191231 66267-813_63607368-e3fb-4d0e-e053-2a91aa0a65da 66267-813 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 NuCare Pharmaceuticals,Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 66267-815_46dc8f62-e6fc-50e3-e054-00144ff8d46c 66267-815 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 NuCare Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 66267-816_46dc8f62-e701-50e3-e054-00144ff8d46c 66267-816 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 NuCare Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 66267-820_56e5e687-b1cf-6b43-e054-00144ff88e88 66267-820 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 NuCare Pharmaceuticals,Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-827_5d7cd5a0-4a85-4084-e053-2a91aa0a686f 66267-827 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 NuCare Pharmaceuticals,Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 66267-832_46dc8f62-e755-50e3-e054-00144ff8d46c 66267-832 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 NuCare Pharmaceuticals, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 66267-835_46dc0641-dfa5-4819-e054-00144ff8d46c 66267-835 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 NuCare Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-841_46dcafbc-9d51-316a-e054-00144ff88e88 66267-841 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19930701 ANDA ANDA072801 NuCare Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 66267-843_46dcafbc-9d83-316a-e054-00144ff88e88 66267-843 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 NuCare Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 66267-857_46dd136c-d565-0450-e054-00144ff8d46c 66267-857 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021127 ANDA ANDA065117 NuCare Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 66267-859_46dd53b9-14ea-537e-e054-00144ff88e88 66267-859 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 NuCare Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 66267-859_46dd68de-8731-1619-e054-00144ff8d46c 66267-859 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 NuCare Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 66267-860_62fde226-6151-2364-e053-2a91aa0a68bb 66267-860 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 NuCare Pharmaceuticals,Inc. PREDNISONE 20 mg/1 N 20191231 66267-872_46de56db-e8aa-7386-e054-00144ff88e88 66267-872 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20051201 ANDA ANDA077241 NuCare Pharmaceuticals,Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 66267-875_46de5018-f04d-4891-e054-00144ff8d46c 66267-875 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 NuCare Pharmaceuticals,Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 66267-877_46de7b61-423e-51bb-e054-00144ff8d46c 66267-877 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070409 ANDA ANDA040597 NuCare Pharmaceuticals,Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 66267-888_56f7966a-c95f-3ce3-e054-00144ff88e88 66267-888 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 NuCare Pharmaceuticals,Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 66267-904_46de9e08-065b-5817-e054-00144ff8d46c 66267-904 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 NuCare Pharmaceuticals, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66267-911_62fe5334-6c3b-4720-e053-2a91aa0a6463 66267-911 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 NuCare Pharmaceuticals,Inc. PREDNISONE 5 mg/1 N 20191231 66267-919_46dee2e1-d4d7-09e7-e054-00144ff88e88 66267-919 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 NuCare Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 66267-924_56f71f04-8468-1f08-e054-00144ff8d46c 66267-924 HUMAN PRESCRIPTION DRUG Tetracaine Hydrochloride Tetracaine Hydrochloride SOLUTION OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER NuCare Pharmaceuticals,Inc. TETRACAINE HYDROCHLORIDE 5 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 66267-925_5d55e52f-c1ac-4415-e053-2a91aa0a97df 66267-925 HUMAN PRESCRIPTION DRUG polycin bacitracin zinc and polymyxin b sulfates OINTMENT OPHTHALMIC 20141112 ANDA ANDA065022 NuCare Pharmaceuticals,Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 66267-932_5425d7f4-8df5-19cc-e054-00144ff8d46c 66267-932 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 NuCare Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66267-933_5439cd3c-da8e-3b96-e054-00144ff8d46c 66267-933 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20060928 ANDA ANDA086414 NuCare Pharmaceuticals,Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66267-934_55a54014-4d92-270f-e054-00144ff88e88 66267-934 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 NuCare Pharmaceuticals,Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66267-935_3b78dfa7-de80-271a-e054-00144ff88e88 66267-935 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 NuCare Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66267-936_58b1fa9d-a303-6dc6-e053-2991aa0a3741 66267-936 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 19931129 ANDA ANDA064052 NuCare Pharmaceuticals,Inc. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 66267-941_575e1d73-5bc5-69b6-e053-2991aa0a469f 66267-941 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SOLUTION OPHTHALMIC 20030325 ANDA ANDA089560 NuCare Pharmaceuticals,Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 66267-943_56be70ed-afe1-6129-e054-00144ff8d46c 66267-943 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 NuCare Pharmaceuticals,Inc. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 66267-952_57825c04-dcb6-b76d-e053-2991aa0a4c1d 66267-952 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 19930128 ANDA ANDA064022 NuCare Pharmaceuticals,Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 66267-954_3b79a1c9-1243-403e-e054-00144ff88e88 66267-954 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 NuCare Pharmaceuticals, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66267-957_58152cb4-550f-2b47-e053-2a91aa0a0f7a 66267-957 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 NuCare Pharmaceuticals,Inc. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 66267-960_5516f9d6-cf6c-58a2-e054-00144ff8d46c 66267-960 HUMAN OTC DRUG Antifungal miconazole nitrate CREAM TOPICAL 20070501 OTC MONOGRAPH FINAL part333C NuCare Pharmaceuticals, Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 66267-961_549c56d2-ef4d-4946-e054-00144ff88e88 66267-961 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20160526 ANDA ANDA040232 NuCare Pharmaceuticals,Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66267-962_5a42185e-4eac-2093-e053-2991aa0a690c 66267-962 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 19950710 ANDA ANDA040014 NuCare Pharmaceuticals,Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 66267-963_593d9870-0214-75e6-e053-2991aa0a0eff 66267-963 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 NuCare Pharmaceuticals,Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-964_575c22c6-4aba-c4dd-e053-2991aa0a11ad 66267-964 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 NuCare Pharmaceuticals Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66267-966_60a4fe22-b957-c293-e053-2a91aa0a9700 66267-966 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20020930 ANDA ANDA089682 NuCare Pharmaceuticals,Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66267-967_5bb279c6-d573-43a2-e053-2991aa0a686e 66267-967 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20060331 ANDA ANDA085025 NuCare Pharmaceuticals,Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66267-969_549c9690-ffca-509d-e054-00144ff88e88 66267-969 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 19970801 OTC MONOGRAPH NOT FINAL part348 NuCare Pharmaceuticals,Inc. HYDROCORTISONE 1 g/100g N 20181231 66267-971_4add8f7b-48f1-6b6a-e054-00144ff88e88 66267-971 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20061213 ANDA ANDA064163 NuCare Pharmaceuticals, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 66267-973_51cbe73c-e5d7-1e6a-e054-00144ff88e88 66267-973 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19900930 ANDA ANDA072488 NuCare Pharmaceuticals, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66267-974_3b670818-602f-0fca-e054-00144ff88e88 66267-974 HUMAN OTC DRUG Eye Wash Purified water SOLUTION OPHTHALMIC 20150917 OTC MONOGRAPH FINAL part349 NuCare Pharmaceuticals, Inc. WATER 99.05 mL/100mL N 20181231 66267-975_5568ac37-604a-2828-e054-00144ff8d46c 66267-975 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 NuCare Pharmaceuticals,Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 66267-980_562e30f6-dda2-6165-e054-00144ff88e88 66267-980 HUMAN OTC DRUG Major Clotrimazole CLOTRIMAZOLE CREAM TOPICAL 20041004 OTC MONOGRAPH FINAL part333C NuCare Pharmaceuticals,Inc. CLOTRIMAZOLE 10 mg/g N 20181231 66267-981_5c60a424-8ec6-003e-e053-2a91aa0ab3f0 66267-981 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20070412 ANDA ANDA065326 NuCare Pharmaceuticals,Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66267-982_549bf887-1ef7-6a75-e054-00144ff8d46c 66267-982 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 NuCare Pharmaceuticals,Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66267-984_552b6d37-5dbd-1421-e054-00144ff88e88 66267-984 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate CREAM TOPICAL 20020901 ANDA ANDA070050 NuCare Pharmaceuticals,Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66267-988_549dfe6a-8349-5f0d-e054-00144ff8d46c 66267-988 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 19950110 OTC MONOGRAPH FINAL part333B NuCare Pharmaceuticals,Inc. BACITRACIN 500 [USP'U]/g N 20181231 66267-993_54c1d2a4-fe97-6efb-e054-00144ff88e88 66267-993 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 NuCare Pharmaceuticals,Inc. AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-994_5780c9e4-5e23-270c-e053-2a91aa0a36ba 66267-994 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 NuCare Pharmaceuticals,Inc. AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 66267-997_617d0bad-757c-1b76-e053-2a91aa0a21d9 66267-997 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate ACETAMINOPHEN and CODEINE PHOSPHATE SOLUTION ORAL 19810821 ANDA ANDA087508 NuCare Pharmaceuticals,Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 66267-998_55b53d66-b44b-429f-e054-00144ff88e88 66267-998 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals,Inc. ACETAMINOPHEN 500 mg/1 N 20181231 66267-999_549b5e8a-27e7-2c08-e054-00144ff88e88 66267-999 HUMAN OTC DRUG Regular Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals,Inc. ACETAMINOPHEN 325 mg/1 N 20181231 66273-0001_357f1627-0281-4a30-be09-9ae2933be6d8 66273-0001 HUMAN OTC DRUG EXENCE WHITE HYDROQUINONE CREAM CUTANEOUS 20110712 OTC MONOGRAPH NOT FINAL part358A AQUIMPEX SPA HYDROQUINONE 4 mL/200mL E 20171231 66273-0002_f8f3f653-d438-47d5-a846-918652369467 66273-0002 HUMAN OTC DRUG EXENCE WHITE HYDROQUINONE LOTION CUTANEOUS 20110712 OTC MONOGRAPH NOT FINAL part358A AQUIMPEX SPA HYDROQUINONE 4 mL/200mL E 20171231 66273-0003_aed6d52b-47fb-4d19-8c4d-c81e20d104f7 66273-0003 HUMAN OTC DRUG CLEAR ACTION HYDROQUINONE CREAM CUTANEOUS 20110719 OTC MONOGRAPH NOT FINAL part358A AQUIMPEX SPA HYDROQUINONE 10 mL/500mL E 20171231 66273-0004_f8ccdf5e-20ce-490a-bb5c-be34b30444e4 66273-0004 HUMAN OTC DRUG CLEAR ACTION HYDROQUINONE LOTION CUTANEOUS 20110719 OTC MONOGRAPH NOT FINAL part358A AQUIMPEX SPA HYDROQUINONE 10 mL/500mL E 20171231 66288-1100_f620fe7d-90ba-49d4-a035-1eb1366e34ce 66288-1100 HUMAN PRESCRIPTION DRUG CEFAZOLIN CEFAZOLIN SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20070101 ANDA ANDA065141 Samson Medical Technologies, L.L.C. CEFAZOLIN SODIUM 100 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66288-1300_f620fe7d-90ba-49d4-a035-1eb1366e34ce 66288-1300 HUMAN PRESCRIPTION DRUG CEFAZOLIN CEFAZOLIN SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20070101 ANDA ANDA065141 Samson Medical Technologies, L.L.C. CEFAZOLIN SODIUM 300 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66288-2075_055f264a-ca6d-4866-81c2-6b2898460880 66288-2075 HUMAN PRESCRIPTION DRUG Cefuroxime Sodium Cefuroxime Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100201 ANDA ANDA065251 Samson Medical Technologies, L.L.C. CEFUROXIME SODIUM 75 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66288-2225_055f264a-ca6d-4866-81c2-6b2898460880 66288-2225 HUMAN PRESCRIPTION DRUG Cefuroxime Sodium Cefuroxime Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20100201 ANDA ANDA065251 Samson Medical Technologies, L.L.C. CEFUROXIME SODIUM 225 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 66288-4100_67b97ad7-92a9-4247-b80a-22fbc312714c 66288-4100 HUMAN PRESCRIPTION DRUG Cefoxitin cefoxitin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160301 ANDA ANDA200938 SAMSON MEDICAL TECHNOLOGIES LLC CEFOXITIN SODIUM 100 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66288-6100_5eed08d4-f329-41a5-9863-5b371feaf47e 66288-6100 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140630 ANDA ANDA090057 Samson Medical Technologies, LLC CEFTRIAXONE SODIUM 100 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 66288-7100_adcdbe6d-0d5e-4068-b48f-fcdfba8440a7 66288-7100 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160601 ANDA ANDA091532 SAMSON MEDICAL TECHNOLOGIES LLC VANCOMYCIN HYDROCHLORIDE 100 g/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 66291-001_98d450d5-db50-42e9-a7bc-f9a9b3cf1b17 66291-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19910101 UNAPPROVED MEDICAL GAS The 3700 Company LLC dba Air Options Respiratory Care OXYGEN 99 L/100L E 20171231 66294-050_cebc4d09-07f3-4cd6-b80f-cf32c3c5a981 66294-050 HUMAN OTC DRUG PRIME SOURCE Antibacterial Hand So ap Chloroxylenol LIQUID TOPICAL 20081015 OTC MONOGRAPH NOT FINAL part333E BUNZL CHLOROXYLENOL .003 mg/mL N 20181231 66294-051_a317f585-13d0-46bf-849a-fe0f362881f8 66294-051 HUMAN OTC DRUG PRIME SOURCE Antibacterial Ltion So ap Chloroxylenol LIQUID TOPICAL 20010815 OTC MONOGRAPH NOT FINAL part333E BUNZL CHLOROXYLENOL .003 mg/mL N 20181231 66294-060_cf71a95e-4a9a-4e9c-8a11-1e557349b9a2 66294-060 HUMAN OTC DRUG PRIME SOURCE Antimicrobial Hand So ap CHLOROXYLENOL LIQUID TOPICAL 20081015 OTC MONOGRAPH NOT FINAL part333E BUNZL CHLOROXYLENOL .003 mg/mL N 20181231 66294-080_9333b075-aa9b-4223-887c-e9c2e192e230 66294-080 HUMAN OTC DRUG PRIME SOURCE Antimicrobial Foaming Hand So ap Chloroxylenol LIQUID TOPICAL 20021115 OTC MONOGRAPH NOT FINAL part333E BUNZL CHLOROXYLENOL .003 mg/mL N 20181231 66294-082_92098749-1fea-43df-b6d6-e26de30c1e2f 66294-082 HUMAN OTC DRUG PRIME SOURCE Antimicrobial Foam So ap Chloroxylenol LIQUID TOPICAL 20071215 OTC MONOGRAPH NOT FINAL part333E BUNZL CHLOROXYLENOL .003 mg/mL N 20181231 66294-083_145b8046-38e3-49b5-824b-8d8f8a26fb94 66294-083 HUMAN OTC DRUG HI-VALU Antimicrobial Foaming Hand So ap Chloroxylenol LIQUID TOPICAL 20110330 OTC MONOGRAPH NOT FINAL part333E BUNZL CHLOROXYLENOL .003 mg/mL N 20181231 66294-400_372f6e5f-701f-4d43-b5ef-619a4eeda20d 66294-400 HUMAN OTC DRUG PRIME SOURCE Antibacterial Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E BUNZL BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 66294-401_933973e3-bb61-4d5e-889c-c56d6342c2de 66294-401 HUMAN OTC DRUG PRIME SOURCE ULTRA Energy Plum Antibacterial Foam Hand So ap Benzalkonium Chloride LIQUID TOPICAL 20171130 OTC MONOGRAPH NOT FINAL part333E BUNZL BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 66294-402_b243bc18-e2e4-4635-adb5-a45fbaf208aa 66294-402 HUMAN OTC DRUG PRIME SOURCE SELECT Plum Antibacterial Foam Hand So ap Benzalkonium Chloride LIQUID TOPICAL 20171130 OTC MONOGRAPH NOT FINAL part333E BUNZL BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 66294-431_b385e0bd-cb80-4504-91ce-b63f9755ec33 66294-431 HUMAN OTC DRUG Prime Source ULTRA Energy Plum Antibacterial Dye Free Foam Hand So ap BENZALKONIUM CHLORIDE LIQUID TOPICAL 20171130 OTC MONOGRAPH NOT FINAL part333E BUNZL Distribution BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 66294-432_edf0475b-44b9-441d-bc87-d054a6a73435 66294-432 HUMAN OTC DRUG Prime Source SELECT Plum Antibacterial Dye Free Foam Hand So ap BENZALKONIUM CHLORIDE LIQUID TOPICAL 20171130 OTC MONOGRAPH NOT FINAL part333E BUNZL Distribution BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 66294-521_eb335d6a-270f-479c-a48e-2f2496ead902 66294-521 HUMAN OTC DRUG ProPower Originals Antimicrobial Foaming So ap CHLOROXYLENOL LIQUID TOPICAL 20150515 OTC MONOGRAPH NOT FINAL part333E BUNZL CHLOROXYLENOL .005 mg/mL N 20181231 66294-523_97b8baee-0ce8-4c14-baef-a7e629282fe9 66294-523 HUMAN OTC DRUG PRIME SOURCE E2 Foam So ap CHLOROXYLENOL LIQUID TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part333E BUNZL CHLOROXYLENOL .5 mg/100mL N 20181231 66294-965_d2ce6586-4eb4-403f-924c-666e703f0412 66294-965 HUMAN OTC DRUG PRIME SOURCE Hand Sanitizer ALCOHOL GEL TOPICAL 20020930 OTC MONOGRAPH NOT FINAL part333E BUNZL ALCOHOL .62 mL/mL N 20181231 66294-966_a54a016e-cc1b-45d0-9217-727bf3f9744b 66294-966 HUMAN OTC DRUG Osceola Skin Care Sani-Gel Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20030730 OTC MONOGRAPH NOT FINAL part333E BUNZL ALCOHOL .62 mL/mL N 20181231 66298-1060_55c630dc-955a-0ce4-e054-00144ff88e88 66298-1060 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAVENOUS 20170802 ANDA ANDA206485 Fresenius Kabi Norge AS MAGNESIUM SULFATE HEPTAHYDRATE 40 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 66298-1070_55c630dc-955a-0ce4-e054-00144ff88e88 66298-1070 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAVENOUS 20170801 ANDA ANDA206485 Fresenius Kabi Norge AS MAGNESIUM SULFATE HEPTAHYDRATE 80 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 66298-2851_3b097f06-b2ff-4dc7-a05e-ecad6b4261f9 66298-2851 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20110531 NDA NDA020533 Fresenius Kabi Norge AS ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 66298-2852_3b097f06-b2ff-4dc7-a05e-ecad6b4261f9 66298-2852 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20110531 NDA NDA020533 Fresenius Kabi Norge AS ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 66298-2856_3b097f06-b2ff-4dc7-a05e-ecad6b4261f9 66298-2856 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION 20110531 NDA NDA020533 Fresenius Kabi Norge AS ROPIVACAINE HYDROCHLORIDE 2 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 66298-2881_3b097f06-b2ff-4dc7-a05e-ecad6b4261f9 66298-2881 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20110531 NDA NDA020533 Fresenius Kabi Norge AS ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 66298-2882_3b097f06-b2ff-4dc7-a05e-ecad6b4261f9 66298-2882 HUMAN PRESCRIPTION DRUG Naropin ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL 20110531 NDA NDA020533 Fresenius Kabi Norge AS ROPIVACAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 66298-7131_55c6e7c5-2f72-267c-e054-00144ff88e88 66298-7131 HUMAN PRESCRIPTION DRUG Linezolid LINEZOLID INJECTION, SOLUTION INTRAVENOUS 20170727 ANDA ANDA204764 Fresenius Kabi Norge AS LINEZOLID 2 mg/mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 66298-8507_616cf61b-abdb-30d7-e053-2a91aa0a3c7d 66298-8507 HUMAN PRESCRIPTION DRUG Moxifloxacin MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20170802 NDA NDA205572 Fresenius Kabi Norge AS MOXIFLOXACIN HYDROCHLORIDE 400 mg/250mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 66302-014_d4486144-cf2c-4dcf-8d82-4800ada91d2b 66302-014 HUMAN PRESCRIPTION DRUG Unituxin DINUTUXIMAB INJECTION INTRAVENOUS 20150310 BLA BLA125516 United Therapeutics Corp. DINUTUXIMAB 3.5 mg/mL Glycolipid Disialoganglioside-directed Antibody [EPC],Glycolipid Disialoganglioside-directed Antibody Interactions [MoA] N 20181231 66302-101_56284a72-0d61-45e3-a4a2-590f69daa86b 66302-101 HUMAN PRESCRIPTION DRUG Remodulin treprostinil INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20020522 NDA NDA021272 United Therapeutics Corporation TREPROSTINIL 20 mg/20mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20191231 66302-102_56284a72-0d61-45e3-a4a2-590f69daa86b 66302-102 HUMAN PRESCRIPTION DRUG Remodulin treprostinil INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20020522 NDA NDA021272 United Therapeutics Corporation TREPROSTINIL 50 mg/20mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20191231 66302-105_56284a72-0d61-45e3-a4a2-590f69daa86b 66302-105 HUMAN PRESCRIPTION DRUG Remodulin treprostinil INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20020522 NDA NDA021272 United Therapeutics Corporation TREPROSTINIL 100 mg/20mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20191231 66302-110_56284a72-0d61-45e3-a4a2-590f69daa86b 66302-110 HUMAN PRESCRIPTION DRUG Remodulin treprostinil INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20020522 NDA NDA021272 United Therapeutics Corporation TREPROSTINIL 200 mg/20mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20191231 66302-150_56284a72-0d61-45e3-a4a2-590f69daa86b 66302-150 HUMAN PRESCRIPTION DRUG Sterile Diluent for Remodulin water INJECTION, SOLUTION INTRAVENOUS 20020522 NDA NDA021272 United Therapeutics Corporation WATER 1 mL/mL N 20191231 66302-206_48a56429-cb1f-4659-ac4b-c2bb1e5316c1 66302-206 HUMAN PRESCRIPTION DRUG TYVASO treprostinil INHALANT ORAL 20090814 NDA NDA022387 United Therapeutics Corp. TREPROSTINIL 1.74 mg/2.9mL Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 66302-300_3d03a0e3-a4b7-4367-95c5-566ccf6f1da2 66302-300 HUMAN PRESCRIPTION DRUG Orenitram treprostinil TABLET, EXTENDED RELEASE ORAL 20131220 NDA NDA203496 United Therapeutics Corp. TREPROSTINIL .125 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 66302-302_3d03a0e3-a4b7-4367-95c5-566ccf6f1da2 66302-302 HUMAN PRESCRIPTION DRUG Orenitram treprostinil TABLET, EXTENDED RELEASE ORAL 20131220 NDA NDA203496 United Therapeutics Corp. TREPROSTINIL .25 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 66302-310_3d03a0e3-a4b7-4367-95c5-566ccf6f1da2 66302-310 HUMAN PRESCRIPTION DRUG Orenitram treprostinil TABLET, EXTENDED RELEASE ORAL 20131220 NDA NDA203496 United Therapeutics Corp. TREPROSTINIL 1 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 66302-325_3d03a0e3-a4b7-4367-95c5-566ccf6f1da2 66302-325 HUMAN PRESCRIPTION DRUG Orenitram treprostinil TABLET, EXTENDED RELEASE ORAL 20131220 NDA NDA203496 United Therapeutics Corp. TREPROSTINIL 2.5 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 66302-350_3d03a0e3-a4b7-4367-95c5-566ccf6f1da2 66302-350 HUMAN PRESCRIPTION DRUG Orenitram treprostinil TABLET, EXTENDED RELEASE ORAL 20131220 NDA NDA203496 United Therapeutics Corp. TREPROSTINIL 5 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 66302-467_030624e0-c32a-4d87-9380-4fea81d63799 66302-467 HUMAN PRESCRIPTION DRUG ADCIRCA Tadalafil TABLET ORAL 20090522 NDA NDA022332 United Therapeutics Corporation TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 66312-110_5e348eb4-182d-2626-e053-2a91aa0abf1c 66312-110 HUMAN PRESCRIPTION DRUG Oraqix lidocaine and prilocaine GEL PERIODONTAL 20040102 NDA NDA021451 DENTSPLY Pharmaceutical LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 66312-176_60c81f4d-a0ed-436f-e053-2a91aa0a7628 66312-176 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 19850122 ANDA ANDA088390 Dentsply Pharmaceutical LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; 10 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 66312-181_60c81f4d-a0ed-436f-e053-2a91aa0a7628 66312-181 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 19850122 ANDA ANDA088389 Dentsply Pharmaceutical LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; 20 mg/mL; ug/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 66312-441_5e352f33-92ae-3c89-e053-2991aa0a606a 66312-441 HUMAN PRESCRIPTION DRUG Polocaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 19841010 ANDA ANDA088387 Dentsply Pharmaceutical MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 66312-540_5bc16e4b-6878-839f-e053-2991aa0abf4a 66312-540 HUMAN PRESCRIPTION DRUG Citanest Forte prilocaine hydrochloride and epinephrine bitartrate INJECTION, SOLUTION SUBMUCOSAL 19651118 NDA NDA021383 Dentsply Pharmaceutical Inc. PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 66312-580_af3a4bc1-5ea5-4173-9207-79e005468573 66312-580 HUMAN PRESCRIPTION DRUG Citanest Forte DENTAL prilocaine HCl and epinephrine INJECTION, SOLUTION PARENTERAL 20171204 ANDA ANDA078959 Dentsply Pharmaceutical Inc. PRILOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 66312-601_5bc1c082-332c-21da-e053-2a91aa0ab84b 66312-601 HUMAN PRESCRIPTION DRUG Articadent Articaine hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBMUCOSAL 20000403 ANDA ANDA020971 Dentsply Pharmaceutical ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 66312-602_5bc1c082-332c-21da-e053-2a91aa0ab84b 66312-602 HUMAN PRESCRIPTION DRUG Articadent Articaine hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBMUCOSAL 20000403 ANDA ANDA020971 Dentsply Pharmaceutical ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 66312-630_5bc1c871-eb79-0c23-e053-2a91aa0a581a 66312-630 HUMAN PRESCRIPTION DRUG Citanest Plain prilocaine hydrochloride INJECTION, SOLUTION SUBMUCOSAL 19651118 ANDA ANDA079235 Dentsply Pharmaceutical Inc. PRILOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 66314-001_d5bf5610-0579-4922-af21-13e01766cd69 66314-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Med Resources, Inc. OXYGEN 99 L/100L E 20171231 66336-002_9a13b0e4-5d05-4eb8-91f7-642e45d95d50 66336-002 HUMAN OTC DRUG good sense all day pain relief Naproxen Sodium TABLET ORAL 19970114 ANDA ANDA074661 Dispensing Solutions, Inc. NAPROXEN SODIUM 220 mg/1 E 20171231 66336-010_a7810248-3b03-4564-a0b8-cee4637d8254 66336-010 HUMAN OTC DRUG EXTRA STRENGTH STOOL SOFTENER LAXATIVE DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20120329 OTC MONOGRAPH NOT FINAL part334 Dispensing Solutions, Inc. DOCUSATE SODIUM 250 mg/1 E 20171231 66336-012_e0e97c61-89c6-4f1c-9d3d-5cff90cf40c5 66336-012 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960229 ANDA ANDA040144 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 66336-019_8f22cff6-3614-4217-9339-754ad3855309 66336-019 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960229 ANDA ANDA040144 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 66336-027_1063e26b-f183-465a-b3a7-dac7e5ee3c67 66336-027 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Dispensing Solutions, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 66336-028_a4fd73f5-7135-4508-a332-4431daad6bdc 66336-028 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Dispensing Solutions, Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 66336-030_2956210a-1b0b-4b63-bf6f-2de8f1374380 66336-030 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Dispensing Solutions, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-033_c55cb2d2-2cba-4ca3-b0ef-50c003b920de 66336-033 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Dispensing Solutions, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 66336-046_f9d114cb-c8ad-4660-ba45-4c08e60839d0 66336-046 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20110923 ANDA ANDA073192 Dispensing Solutions, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] E 20171231 66336-047_ed7a1b9f-57f7-40df-9fdc-89810fbb5547 66336-047 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 Dispensing Solutions, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 66336-052_1397062c-64a5-49b9-b3f3-fe7c0edd8f7a 66336-052 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Dispensing Solutions, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 E 20171231 66336-055_72c74c12-f8d9-47e4-968c-95591f7766d2 66336-055 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Dispensing Solutions, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 66336-056_ec976214-bd1c-4319-b472-98e6cf831c78 66336-056 HUMAN PRESCRIPTION DRUG Zaleplon Zaleplon CAPSULE ORAL 20080606 ANDA ANDA077239 Dispensing Solutions, Inc. ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 66336-058_5806e4cf-77b1-4d57-8ce8-ef11dc30144c 66336-058 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 Dispensing Solutions, Inc. PREDNISONE 10 mg/1 E 20171231 66336-058_cb2e8970-aff2-4196-87de-29b458336284 66336-058 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA084122 Dispensing Solutions, Inc. PREDNISONE 10 mg/1 E 20171231 66336-059_30993951-a2b3-4106-9ff1-639c17d8ff0e 66336-059 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Dispensing Solutions, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 CIII E 20171231 66336-063_d4f90f31-4a9f-43c4-8ade-5841fc60f0f3 66336-063 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 Dispensing Solutions, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 66336-074_3fe12e39-1a78-4177-b703-cad97bcd26b4 66336-074 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 Dispensing Solutions, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 66336-080_58228cbd-44f7-4482-ab77-df7e4e60b688 66336-080 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Dispensing Solutions, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 66336-085_3dfdb1c3-342c-411c-a214-4d0ebeb6be8c 66336-085 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060718 ANDA ANDA040622 Dispensing Solutions, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 66336-086_0b50bcf8-f907-4d0b-90a2-19498757fe36 66336-086 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20050527 ANDA ANDA040574 Dispensing Solutions, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 66336-094_b8c45bf4-669b-434a-a646-9891555c263d 66336-094 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20030212 ANDA ANDA040392 Dispensing Solutions, Inc. PREDNISONE 20 mg/1 E 20171231 66336-096_7b4582e6-e63b-49a6-ab60-608ef3897946 66336-096 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET ORAL 19941001 OTC MONOGRAPH FINAL part341 Dispensing Solutions, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 E 20171231 66336-099_4473f13c-d981-44d8-88cf-8976a911727f 66336-099 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20091201 ANDA ANDA077918 Dispensing Solutions, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-106_1405c0fe-a865-445f-940f-52db142784a4 66336-106 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960412 ANDA ANDA040157 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 750 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 66336-115_34dce80b-24b6-4df8-b006-de2d135efbc0 66336-115 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 66336-115_562fa13f-1a38-40f0-8ac4-8de2a46ed25e 66336-115 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 66336-127_753fe817-2105-4f60-8144-5f2560496201 66336-127 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20071003 ANDA ANDA077410 Dispensing Solutions, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 66336-135_697f587f-f37e-4ed2-9d54-dd346766346c 66336-135 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20090730 ANDA ANDA076758 Dispensing Solutions, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 66336-147_9c4d3166-fb57-445e-b13e-1d19a0a5b0cb 66336-147 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN oxycodone hydrochloride and acetaminophen TABLET ORAL 20110308 ANDA ANDA040545 Dispensing Solutions, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 66336-168_0e4c59f8-9fb0-42b3-9464-10d4c54b0289 66336-168 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Dispensing Solutions, Inc. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 66336-184_5f07db7c-c369-4635-b44c-6cd2a75aca8a 66336-184 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20030329 ANDA ANDA040412 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 66336-185_fe6e20b4-0ab2-4ff4-8992-2f3ac8eac2ce 66336-185 HUMAN PRESCRIPTION DRUG PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAPSULE ORAL 19980601 ANDA ANDA040875 Dispensing Solutions, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 66336-187_3899134c-fa4f-435f-9786-ffc605963e1b 66336-187 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Dispensing Solutions, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 66336-214_cf313cc0-44c0-4f55-a021-8fab00af41ca 66336-214 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20071012 NDA NDA022145 Dispensing Solutions, Inc. RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] E 20171231 66336-219_ce688852-a790-4180-92db-b83cbdab8c3d 66336-219 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087801 Dispensing Solutions, Inc. PREDNISONE 2.5 mg/1 E 20171231 66336-224_0a4641d5-de81-4696-a35b-9d2174a347a5 66336-224 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Dispensing Solutions, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 66336-233_8e39026d-40d6-4235-8422-08408281f3f6 66336-233 HUMAN OTC DRUG Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Dispensing Solutions, Inc. ACETAMINOPHEN 650 mg/1 E 20171231 66336-238_ef637460-8812-461e-a394-21a610bbebd4 66336-238 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Dispensing Solutions, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-269_4bbb1030-1e27-4761-9414-2a1f3384894a 66336-269 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031101 ANDA ANDA076467 Dispensing Solutions, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 66336-316_4f00b5a8-165b-4081-99c7-a33bf3273416 66336-316 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Dispensing Solutions, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-336_64486ca9-85d5-40d1-9a5b-01d52521ed7b 66336-336 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077946 Dispensing Solutions, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 66336-337_9e8fb504-77b7-4765-9191-aadff6316cd5 66336-337 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM ANHYDROUS .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-338_1239c290-23b1-4b83-97b9-d9e5e45fa30b 66336-338 HUMAN PRESCRIPTION DRUG METHOTREXATE METHOTREXATE TABLET ORAL 19531207 NDA NDA008085 Dispensing Solutions, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 66336-340_d26d25bc-6674-4a2a-b6b1-46beec6554b6 66336-340 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-341_d26d25bc-6674-4a2a-b6b1-46beec6554b6 66336-341 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-342_d26d25bc-6674-4a2a-b6b1-46beec6554b6 66336-342 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-344_9705bec8-2f8d-4aa0-9009-7b4e83077958 66336-344 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20031023 ANDA ANDA040527 Dispensing Solutions, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 66336-354_00c820ad-3f5e-4a79-a864-4e674da6f285 66336-354 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Dispensing Solutions, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 66336-357_9e8fb504-77b7-4765-9191-aadff6316cd5 66336-357 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20071001 NDA NDA021210 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM ANHYDROUS .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-363_7ed5ee28-ccc4-43ea-8c05-4626e0c9fae2 66336-363 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 Dispensing Solutions, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 66336-367_b8ad55d8-697c-4859-b1b9-56e2c7ee8260 66336-367 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20060727 ANDA ANDA077836 Dispensing Solutions, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 66336-377_5c6c99d0-578e-49a1-847d-4b1f7cceaab6 66336-377 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063065 Dispensing Solution, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 66336-393_fe36b318-a80b-4c21-9280-0a50e441dafb 66336-393 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Dispensing Solutions, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 66336-402_f2b44f85-db0d-46e4-9fa0-282203cc6578 66336-402 HUMAN PRESCRIPTION DRUG Methergine methylergonovine maleate TABLET, COATED ORAL 19461119 NDA NDA006035 Dispensing Solutions, Inc. METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] E 20171231 66336-406_04707455-a0b9-41ce-9b94-fd416ad2aaf8 66336-406 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19960222 ANDA ANDA040143 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 650 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 66336-408_a97c38c3-d6af-44e0-94ba-e8457f992469 66336-408 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040356 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 66336-427_9e8fb504-77b7-4765-9191-aadff6316cd5 66336-427 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM ANHYDROUS .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-428_cb2e8970-aff2-4196-87de-29b458336284 66336-428 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 19820422 ANDA ANDA087800 Dispensing Solutions, Inc. PREDNISONE 1 mg/1 E 20171231 66336-429_5afb5523-36b4-4def-af52-36cc92d187a9 66336-429 HUMAN PRESCRIPTION DRUG clarithromycin clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080101 ANDA ANDA065145 Dispensing Solutions, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 66336-430_2956210a-1b0b-4b63-bf6f-2de8f1374380 66336-430 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Dispensing Solutions, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-437_7da07df7-0b87-4c0d-9600-1d9189391587 66336-437 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 Dispensing Solutions, Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV E 20171231 66336-439_7d9f35d2-ad0e-415c-b145-10382b7b5a7f 66336-439 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 Dispensing Solutions, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 66336-442_c2b43b77-8ebb-4559-aaae-2d17741bce3e 66336-442 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19881202 ANDA ANDA089971 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 66336-444_90381683-704b-410f-91ad-1a5c41fcf657 66336-444 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 66336-460_72ea5fd8-73c4-47a8-976c-3245bba15f11 66336-460 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Dispensing Solutions, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 66336-463_2925c37a-365e-472b-ac2c-6216247d7bd2 66336-463 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Dispensing Solutions, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-470_697f587f-f37e-4ed2-9d54-dd346766346c 66336-470 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET ORAL 20090730 ANDA ANDA076758 Dispensing Solutions, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 66336-478_3b4adae5-b1f7-4df1-a3d5-d7aea1200059 66336-478 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Dispensing Solutions, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 66336-479_22d12fc3-c111-4b1a-908e-f65725378066 66336-479 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19780719 ANDA ANDA084612 Dispensing Solutions, Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 66336-486_9b60cb0d-4259-49dc-8b29-0dcf504cf40f 66336-486 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077068 Dispensing Solutions, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 66336-488_891a2078-2804-4766-98fe-584fe503b34d 66336-488 HUMAN OTC DRUG ED A-HIST CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20111008 OTC MONOGRAPH FINAL part341 Dispensing Solutions, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 E 20171231 66336-502_f7aa7607-6319-4a5e-9a21-3a3e97b2e499 66336-502 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022207 Dispensing Solutions, Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 66336-533_1635b9ca-beee-46ec-97a9-2cda23cad167 66336-533 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA090568 Dispensing Solutions, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 66336-536_7604a761-8bd8-49de-a2be-4ef59212f0dd 66336-536 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-537_7604a761-8bd8-49de-a2be-4ef59212f0dd 66336-537 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-554_4a306212-0548-4ad5-9885-2198944bc6f5 66336-554 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Dispensing Solutions, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 66336-555_450d00fd-2711-4689-9fb3-1e6cac7fafb7 66336-555 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20090107 ANDA ANDA040766 Dispensing Solutions, Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] E 20171231 66336-556_2956210a-1b0b-4b63-bf6f-2de8f1374380 66336-556 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Dispensing Solutions, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-558_3ecd7b1f-5aef-41b8-8ab7-1897f87c347c 66336-558 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19860710 ANDA ANDA062676 Dispensing Solutions, Inc. DOXYCYCLINE HYCLATE 50 mg/1 E 20171231 66336-560_368c7e88-5379-430b-b396-18a6b34cb10d 66336-560 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 Dispensing Solutions, Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 E 20171231 66336-561_7c798476-f38e-40df-8755-a0edc055ec21 66336-561 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Dispensing Solutions, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 E 20171231 66336-566_02ba1d7c-aeef-452b-b748-6ecc1d88e340 66336-566 HUMAN PRESCRIPTION DRUG Cialis Tadalafil TABLET, FILM COATED ORAL 20031126 NDA NDA021368 Dispensing Solutions, Inc. TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 66336-567_7d9f35d2-ad0e-415c-b145-10382b7b5a7f 66336-567 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20070709 ANDA ANDA078150 Dispensing Solutions, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 66336-570_9edeab5c-754e-4739-89c1-a47f7a7f9873 66336-570 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20101201 ANDA ANDA076077 Dispensing Solutions, Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 66336-571_1ec9d9bb-619a-461f-b5ff-8ea35a02b3f9 66336-571 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-572_e920b01c-e21f-434e-b760-6dbd1b187ef6 66336-572 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20061002 ANDA ANDA077912 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 66336-579_fbb3d03a-51e4-4e49-99c3-c8ad36737d28 66336-579 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071134 Dispensing Solutions, Inc. DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 66336-581_09c8569c-3a69-4d0b-8dd5-7c66bc47d534 66336-581 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19890503 ANDA ANDA071611 Dispensing Solutions, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 66336-586_221b9a3d-d734-443f-94b4-270a4d90fcc9 66336-586 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20010209 ANDA ANDA075665 Dispensing Solutions, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-588_31703dcf-5f13-4729-8e4d-9ed581b4cfd9 66336-588 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Dispensing Solutions, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 66336-591_c12f402b-f00b-466d-a6ea-862f00f81ec7 66336-591 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-600_ecb43b12-9ed4-45f7-8eb3-a03b985e912c 66336-600 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20010525 NDA NDA021301 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-601_ecb43b12-9ed4-45f7-8eb3-a03b985e912c 66336-601 HUMAN PRESCRIPTION DRUG LEVOXYL LEVOTHYROXINE SODIUM TABLET ORAL 20010525 NDA NDA021301 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-602_e395e4b2-97f1-4910-b1d6-024b2020d9c3 66336-602 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Dispensing Solutions, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 66336-603_9e7d698d-43c2-4ea4-b5ae-298d3bc2f4d6 66336-603 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20110118 ANDA ANDA040159 Dispensing Solutions, Inc. MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 66336-604_95753e38-0d1c-410c-9d1e-7e09dea1437c 66336-604 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20070511 ANDA ANDA076745 Dispensing Solutions, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 66336-608_15395dfd-3685-45ef-bbcb-13f95dcedf4d 66336-608 HUMAN PRESCRIPTION DRUG misoprostol MISOPROSTOL TABLET ORAL 20091227 NDA AUTHORIZED GENERIC NDA019268 Dispensing Solutions, Inc. MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 66336-619_9b1cedc1-d578-4e5e-a130-21dca030f666 66336-619 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin and Caffeine Butalbital, Aspirin and Caffeine TABLET ORAL 19790605 ANDA ANDA086162 Dispensing Solutions, Inc. BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII E 20171231 66336-620_f78847e5-3b80-4508-b030-452441c74a4e 66336-620 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20110120 ANDA ANDA071523 Dispensing Solutions, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 66336-623_5c5af70c-6daf-4514-823e-b089adc31785 66336-623 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20120116 ANDA ANDA040734 Dispensing Solutions, Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] E 20171231 66336-624_8e2fad31-7e6d-426c-b2f4-487d870f2374 66336-624 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 Dispensing Solutions, Inc. LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] E 20171231 66336-635_ddc02aa9-0009-49f7-9efc-d52acf1eacd6 66336-635 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Dispensing Solutions, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 66336-663_5270706a-c8eb-47c1-9650-e80d26407ba8 66336-663 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET OCCLUSIVE DRESSING TECHNIQUE 20081223 ANDA ANDA089859 Dispensing Solutions, Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 66336-665_e1947fbe-c5d4-4f6c-b364-a4734ff91775 66336-665 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101228 ANDA ANDA076958 Dispensing Solutions, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 66336-666_e1947fbe-c5d4-4f6c-b364-a4734ff91775 66336-666 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101228 ANDA ANDA076958 Dispensing Solutions, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 66336-669_d3212136-8ef9-4e20-9395-27f5bf63e5ca 66336-669 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Dispensing Solutions, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 66336-670_37836856-4c09-43d3-ba39-f42da6614a05 66336-670 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 66336-673_0a4641d5-de81-4696-a35b-9d2174a347a5 66336-673 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Dispensing Solutions, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 66336-687_8af5d40d-42f1-4201-9ec6-bd96efcd6e3a 66336-687 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20101206 ANDA ANDA091549 Dispensing Solutions, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-706_64218455-e1e2-4e40-bd32-5002d2d1555d 66336-706 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20121212 ANDA ANDA075876 Dispensing Solutions, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 66336-712_57076caf-0ccd-484f-9e80-8bd934593387 66336-712 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19990512 ANDA ANDA074686 Dispensing Solutions, Inc. GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 66336-718_09e0c026-4724-4844-8c63-a4bb5f5d068b 66336-718 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Dispensing Solutions, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 66336-718_e0d2aa04-ee64-4806-9ef0-7a79cd869aa7 66336-718 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Dispensing Solutions, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 66336-720_201a5bf4-905f-4a4f-856b-114f90dce681 66336-720 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET, FILM COATED ORAL 20110906 ANDA ANDA090199 Dispensing Solutions, Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 66336-722_07a2440f-fa26-4502-bd79-f4c6d1942c8c 66336-722 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20010131 ANDA ANDA075845 Dispensing Solutions, Inc. OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-748_877be95b-3967-4f8b-b8d7-686fd27c9b21 66336-748 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19970414 ANDA ANDA040155 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 650 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 66336-774_b755804d-e016-433c-bb54-760ad571e5af 66336-774 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20091201 ANDA ANDA077918 Dispensing Solutions, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-776_b32626f0-8320-437e-ae46-1c265f73fb32 66336-776 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20070827 ANDA ANDA040742 Dispensing Solutions, Inc. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 66336-786_bdaaa82c-2eae-48cb-832f-4a7f4b2c1fd6 66336-786 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20070309 ANDA ANDA077901 Dispensing Solutions, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 66336-792_fb030a15-7594-4ab1-8162-5ca19944229f 66336-792 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Dispensing Solutions, Inc. DOCUSATE SODIUM 100 mg/1 E 20171231 66336-793_ace9dc28-4a9d-4e37-b445-564afb44b268 66336-793 HUMAN PRESCRIPTION DRUG ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED ORAL 20070625 ANDA ANDA077050 Dispensing Solutions, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 66336-800_ed7a1b9f-57f7-40df-9fdc-89810fbb5547 66336-800 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070108 ANDA ANDA071141 Dispensing Solutions, Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 66336-801_c6ad56eb-e84c-457a-becd-9ae66729cedd 66336-801 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20110501 NDA NDA021342 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 66336-815_f9f24b7c-2184-463c-bd18-70edd0b271db 66336-815 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20120201 ANDA ANDA091416 Dispensing Solutions, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-817_373fcf1b-f3b5-4a6b-b4da-12e81fceb7fb 66336-817 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Dispensing Solutions, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-819_31703dcf-5f13-4729-8e4d-9ed581b4cfd9 66336-819 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Dispensing Solutions, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 66336-834_9b60cb0d-4259-49dc-8b29-0dcf504cf40f 66336-834 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077156 Dispensing Solutions, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 66336-843_9cf56195-c94a-4fb0-8ce7-813c55a0502f 66336-843 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Dispensing Solutions, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 66336-851_cbc61b79-5794-4e61-b33c-a11638848845 66336-851 HUMAN PRESCRIPTION DRUG CALCITRIOL CALCITRIOL CAPSULE ORAL 20090826 NDA AUTHORIZED GENERIC NDA018044 Dispensing Solutions, Inc. CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 66336-857_6a51f874-89d9-4437-a8a8-462bb3a08801 66336-857 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 Dispensing Solutions, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 66336-871_bd7d3e87-d87b-456e-b23f-5ee3b45ad366 66336-871 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide TABLET ORAL 20110216 ANDA ANDA091528 Dispensing Solutions, Inc. HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE 5; 1.5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 66336-878_1ceb01db-7890-43fa-b31c-1c73a56e7032 66336-878 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 19980520 ANDA ANDA075009 Dispensing Solutions, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-897_05293257-1c22-45f7-8c6a-204043bab144 66336-897 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET OCCLUSIVE DRESSING TECHNIQUE 20080312 ANDA ANDA077455 Dispensing Solutions, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 66336-902_6b11fa9e-c8a5-4497-b5c5-13945879cdbb 66336-902 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 Dispensing Solutions, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 66336-907_553f273b-5017-4e27-bf7c-7828a5f74c54 66336-907 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20090817 ANDA ANDA040833 Dispensing Solutions, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] E 20171231 66336-911_43b8794f-1137-4f23-be99-f2c7c3a63444 66336-911 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 Dispensing Solutions, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 66336-915_54c08b26-940a-468e-9b3d-9bda465caa48 66336-915 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 Dispensing Solutions, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 66336-916_3924e768-3967-4e22-9b2c-ac8bb80dcc27 66336-916 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20060829 ANDA ANDA040750 Dispensing Solutions, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 66336-921_2c4f8e57-2745-43cd-a209-30d4c9ad58a7 66336-921 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 19980301 ANDA ANDA040268 Dispensing Solutions, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 66336-932_dfa9fa44-a29c-4f1f-9249-23ecd9e2efdf 66336-932 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20080925 ANDA ANDA078491 Dispensing Solutions, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 66336-940_d68cf56e-4789-449f-aab0-49d58b2e2f76 66336-940 HUMAN PRESCRIPTION DRUG CELEBREX CELECOXIB CAPSULE ORAL 19981002 NDA NDA020998 Dispensing Solutions, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66336-945_5819342b-4010-426a-96c2-cff5fdc5d1be 66336-945 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20100526 ANDA ANDA074424 Dispensing Solutions, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 66336-973_8194964b-a7fb-4f75-98b4-3a48f4f20a34 66336-973 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Dispensing Solutions, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 66336-980_31703dcf-5f13-4729-8e4d-9ed581b4cfd9 66336-980 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Dispensing Solutions, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 66343-001_57004a41-dd28-40fd-a0a0-9a50bde92032 66343-001 HUMAN OTC DRUG Anxiovita PIPER METHYSTICUM ROOT, HYPERICUM PERFORATUM, SUS SCROFA CEREBELLUM, and ACONITUM NAPELLUS LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG PIPER METHYSTICUM ROOT; HYPERICUM PERFORATUM; SUS SCROFA CEREBELLUM; ACONITUM NAPELLUS 12; 21; 200; 18 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_M]/mL E 20171231 66343-002_6ec595e1-0851-4637-b51e-3971b760af1c 66343-002 HUMAN OTC DRUG Geovita IRON, SILICON DIOXIDE, COPPER, FORMIC ACID, and SUS SCROFA CEREBELLUM LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG IRON; SILICON DIOXIDE; COPPER; FORMIC ACID; SUS SCROFA CEREBELLUM 6; 12; 21; 21; 21 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-003_fa5f780f-fb66-404e-820b-4588a7a8e81f 66343-003 HUMAN OTC DRUG Neurovita MELISSA OFFICINALIS, SUS SCROFA CEREBELLUM, AMBERGRIS, CINCHONA OFFICINALIS BARK, CUPRIC ACETATE, and PHOSPHORUS LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG MELISSA OFFICINALIS; SUS SCROFA CEREBELLUM; AMBERGRIS; CINCHONA OFFICINALIS BARK; CUPRIC ACETATE; PHOSPHORUS 4; 21; 21; 50; 200; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_M]/mL E 20171231 66343-004_fbd55255-19c8-4811-a7c3-3ecdf217e948 66343-004 HUMAN OTC DRUG Paravita Formica rufa, Sus Scrofa Cerebellum, Acetylcholine, and Scabies Lesion Lysate (Human) LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG FORMICA RUFA; SUS SCROFA CEREBELLUM; ACETYLCHOLINE; SCABIES LESION LYSATE (HUMAN) 12; 21; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 66343-005_24170b2d-a369-49f1-a161-52725f70d210 66343-005 HUMAN OTC DRUG Simvita Claviceps Purpurea Sclerotium, Sus Scrofa Cerebellum, Epinephrine, and Tuberculin Purified Protein Derivative LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG CLAVICEPS PURPUREA SCLEROTIUM; SUS SCROFA CEREBELLUM; EPINEPHRINE; TUBERCULIN PURIFIED PROTEIN DERIVATIVE 12; 21; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 66343-006_81b423c7-137a-44bb-a6e7-fe64c0e9e691 66343-006 HUMAN OTC DRUG Chavita 1 SILICON DIOXIDE, ACTIVATED CHARCOAL, URTICA URENS, FRANKINCENSE, SUS SCROFA OVARY, AND BOS TAURUS TESTICLE LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG SILICON DIOXIDE; ACTIVATED CHARCOAL; URTICA URENS; FRANKINCENSE; SUS SCROFA OVARY; BOS TAURUS TESTICLE 21; 50; 21; 21; 21; 21 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-007_049822e0-d69f-492c-aed8-0d3446ed8758 66343-007 HUMAN OTC DRUG Chavita 2 PLATINUM, CAUSTICUM, SILVER CYANIDE, THUJA OCCIDENTALIS LEAFY TWIG, JUNIPER BERRY, LAVANDULA ANGUSTIFOLIA WHOLE, and SUS SCROFA ADRENAL GLAND LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG PLATINUM; CAUSTICUM; SILVER CYANIDE; THUJA OCCIDENTALIS LEAFY TWIG; JUNIPER BERRY; LAVANDULA ANGUSTIFOLIA WHOLE; SUS SCROFA ADRENAL GLAND 50; 200; 21; 21; 21; 21; 21 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-008_5233c89f-ba71-4bbd-a158-f9873cb3c391 66343-008 HUMAN OTC DRUG Chavita 3 Silver Cyanide, Strychnos Nux-Vomica Seed, Lycopodium Clavatum Spore, Chelidonium majus, Ginger, Matricaria Recutita, and Sus Scrofa Pancreas LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG SILVER CYANIDE; STRYCHNOS NUX-VOMICA SEED; LYCOPODIUM CLAVATUM SPORE; CHELIDONIUM MAJUS; GINGER; MATRICARIA RECUTITA; SUS SCROFA PANCREAS 21; 50; 200; 21; 21; 21; 21 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-009_3b135a90-a9e1-4d53-803e-b3ca06211043 66343-009 HUMAN OTC DRUG Chavita 4 IRON, ZINC VALERATE DIHYDRATE, GOLD, EUCALYPTUS GLOBULUS LEAF, CETRARIA ISLANDICA SUBSP. ISLANDICA, CRATAEGUS LAEVIGATA WHOLE, and BOS TAURUS THYMUS LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG IRON; ZINC VALERATE DIHYDRATE; GOLD; EUCALYPTUS GLOBULUS LEAF; CETRARIA ISLANDICA SUBSP. ISLANDICA; CRATAEGUS LAEVIGATA WHOLE; BOS TAURUS THYMUS 50; 200; 21; 21; 21; 21; 21 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-010_4e1bc603-b666-4e23-8193-77832b282f19 66343-010 HUMAN OTC DRUG Chavita 5 THUJA OCCIDENTALIS LEAFY TWIG, PHOSPHORUS, VIOLA TRICOLOR, and THYROID, PORCINE LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG THUJA OCCIDENTALIS LEAFY TWIG; PHOSPHORUS; VIOLA TRICOLOR; THYROID, PORCINE 50; 21; 21; 21 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-011_ed3ba3d8-58b5-40fe-9a46-a2c15576727d 66343-011 HUMAN OTC DRUG Chavita 6 DELPHINIUM STAPHISAGRIA SEED, LEAD, VISCUM ALBUM FRUITING TOP, and SUS SCROFA CEREBELLUM LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG DELPHINIUM STAPHISAGRIA SEED; LEAD; VISCUM ALBUM FRUITING TOP; SUS SCROFA CEREBELLUM 50; 21; 21; 21 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-012_3b29b047-10f8-492d-a174-56f625dd9ef3 66343-012 HUMAN OTC DRUG Chavita 7 CALCIUM SULFATE ANHYDROUS, GOLD, LACHESIS MUTA VENOM, VALERIANA OFFICINALIS WHOLE, HYPERICUM PERFORATUM, ACHILLEA MILLEFOLIUM, and SUS SCROFA CEREBRUM LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG CALCIUM SULFATE ANHYDROUS; GOLD; LACHESIS MUTA VENOM; VALERIANA OFFICINALIS WHOLE; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; SUS SCROFA CEREBRUM 200; 200; 21; 21; 21; 21; 21 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-013_4a245524-7b31-454f-8344-0904e4d10e03 66343-013 HUMAN OTC DRUG Emvita 1 POTASSIUM CARBONATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, LACHESIS MUTA VENOM, NAJA NAJA VENOM, PULSATILLA VULGARIS, SUS SCROFA OVARY, and BOS TAURUS TESTICLE LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG POTASSIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LACHESIS MUTA VENOM; NAJA NAJA VENOM; PULSATILLA VULGARIS; SUS SCROFA OVARY; BOS TAURUS TESTICLE 800; 16; 18; 21; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-014_96bc54b1-f005-4d9d-b4e6-929f4423c925 66343-014 HUMAN OTC DRUG Emvita 2 POTASSIUM PHOSPHATE, DIBASIC, COPPER, VERATRUM ALBUM ROOT, VIPERA BERUS VENOM, SUS SCROFA OVARY, and BOS TAURUS TESTICLE LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG POTASSIUM PHOSPHATE, DIBASIC; COPPER; VERATRUM ALBUM ROOT; VIPERA BERUS VENOM; SUS SCROFA OVARY; BOS TAURUS TESTICLE 800; 18; 16; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-015_1f0bb9d3-2882-44bc-af99-b1d03ba7c6d1 66343-015 HUMAN OTC DRUG Emvita 3 APIS MELLIFERA, CALCIUM SULFIDE, CONIUM MACULATUM FLOWERING TOP, LYCOPERDON UTRIFORME FRUITING BODY, SUS SCROFA OVARY, and BOS TAURUS TESTICLE LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG APIS MELLIFERA; CALCIUM SULFIDE; CONIUM MACULATUM FLOWERING TOP; LYCOPERDON UTRIFORME FRUITING BODY; SUS SCROFA OVARY; BOS TAURUS TESTICLE 800; 16; 18; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-016_eee66b8c-2939-468c-83e0-cdcca0bcf30d 66343-016 HUMAN OTC DRUG Emvita 4 Platinum, Kerosene, Datura Stramonium, Apis Mellifera, Sus Scrofa Ovary, and Bos Taurus Testicle LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG PLATINUM; KEROSENE; DATURA STRAMONIUM; APIS MELLIFERA; SUS SCROFA OVARY; BOS TAURUS TESTICLE 800; 16; 18; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-017_1f7cae5b-8428-4a5e-8e8d-0c61c395ebc9 66343-017 HUMAN OTC DRUG Emvita 5 Bufo Bufo Cutaneous Gland, Pulsatilla Vulgaris, Copper, Zinc, Phosphorus, and Sus Scrofa Adrenal Gland LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG BUFO BUFO CUTANEOUS GLAND; PULSATILLA VULGARIS; COPPER; ZINC; PHOSPHORUS; SUS SCROFA ADRENAL GLAND 800; 16; 18; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-018_9bea91c1-33e8-4d23-9eba-407a8576d569 66343-018 HUMAN OTC DRUG Emvita 6 PHOSPHORUS, CLAVICEPS PURPUREA SCLEROTIUM, ARSENIC TRIOXIDE, LACHESIS MUTA VENOM, AND SUS SCROFA ADRENAL GLAND LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG PHOSPHORUS; CLAVICEPS PURPUREA SCLEROTIUM; ARSENIC TRIOXIDE; LACHESIS MUTA VENOM; SUS SCROFA ADRENAL GLAND 800; 16; 18; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-019_81f36202-1181-4ed9-bbaa-8b403188ee08 66343-019 HUMAN OTC DRUG Emvita 7 Lachesis Muta Venom, Lycopodium Clavatum Spore, Anacardium Occidentale Fruit, Phosphorus, and Sus Scrofa Adrenal Gland LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; ANACARDIUM OCCIDENTALE FRUIT; PHOSPHORUS; SUS SCROFA ADRENAL GLAND 800; 16; 18; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-020_c9689c8e-0f64-45de-8bb7-c96f9c3d4c08 66343-020 HUMAN OTC DRUG Emvita 8 Ammonium carbonate, Graphite, Quinine arsenite, Opium, and Oyster shell calcium carbonate, crude LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG AMMONIUM CARBONATE; GRAPHITE; QUININE ARSENITE; OPIUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE 800; 16; 18; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-021_425a8d30-61f0-4337-a3e9-7796f07d0d2f 66343-021 HUMAN OTC DRUG Emvita 9 LYCOPODIUM CLAVATUM SPORE, LYCOSA TARANTULA, SULFUR, CALCIUM SULFIDE, and SUS SCROFA PANCREAS LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA; SULFUR; CALCIUM SULFIDE; SUS SCROFA PANCREAS 800; 16; 18; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-022_a4948f16-85ae-4052-8159-9d6f923dbc8a 66343-022 HUMAN OTC DRUG Emvita 10 CALCIUM SULFIDE, LACHESIS MUTA VENOM, ARISAEMA TRIPHYLLUM ROOT, KEROSENE, CHASTE TREE, and SUS SCROFA PANCREAS LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG CALCIUM SULFIDE; LACHESIS MUTA VENOM; ARISAEMA TRIPHYLLUM ROOT; KEROSENE; CHASTE TREE; SUS SCROFA PANCREAS 800; 16; 18; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-023_406b8efc-3b8e-4661-9b60-81a75fc03a27 66343-023 HUMAN OTC DRUG Emvita 11 IRON, STRYCHNOS IGNATII SEED, CLAVICEPS PURPUREA SCLEROTIUM, COPPER, and SUS SCROFA PANCREAS LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG IRON; STRYCHNOS IGNATII SEED; CLAVICEPS PURPUREA SCLEROTIUM; COPPER; SUS SCROFA PANCREAS 800; 18; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-024_09943a3c-4f7f-49fb-adce-e9c8fe981496 66343-024 HUMAN OTC DRUG Emvita 12 Apis mellifera, Naja Naja venom, Strychnos ignatii seed, Barium carbonate, Graphite, and Opium LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG APIS MELLIFERA; NAJA NAJA VENOM; STRYCHNOS IGNATII SEED; BARIUM CARBONATE; GRAPHITE; OPIUM 800; 800; 16; 18; 21; 21 [hp_C]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-025_5d8011c3-fa3e-4fc5-8432-ee66198f3a69 66343-025 HUMAN OTC DRUG Emvita 13 Bothrops Atrox Venom, Oyster shell calcium carbonate, crude, Graphite, Anacardium Occidentale Fruit, and Sus Scrofa Thymus LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG BOTHROPS ATROX VENOM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; ANACARDIUM OCCIDENTALE FRUIT; SUS SCROFA THYMUS 800; 16; 18; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-026_dcd12093-66bd-4371-98da-3c4edebf2ed7 66343-026 HUMAN OTC DRUG Emvita 14 DATURA STRAMONIUM, MOSCHUS MOSCHIFERUS MUSK SAC RESIN, SULFUR, HYOSCYAMUS NIGER, LEAD, OYSTER SHELL CALCIUM CARBONATE, CRUDE, and SUS SCROFA THYMUS LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG DATURA STRAMONIUM; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; SULFUR; HYOSCYAMUS NIGER; LEAD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SUS SCROFA THYMUS 800; 16; 18; 21; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-027_5f3250a3-cb4e-440c-b7a0-b8b524c8929b 66343-027 HUMAN OTC DRUG Emvita 15 Apis mellifera, Zinc, Lachesis muta venom, Phosphorus, and Sus Scrofa Thymus LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG APIS MELLIFERA; ZINC; LACHESIS MUTA VENOM; PHOSPHORUS; SUS SCROFA THYMUS 800; 16; 18; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-028_3adc6f0b-f7cd-4bc2-bab9-0f7e736ecfa1 66343-028 HUMAN OTC DRUG Emvita 16 Aconitum napellus, Opium, Ambergris, Claviceps purpurea sclerotium, Zinc, and Sus scrofa thymus LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG ACONITUM NAPELLUS; OPIUM; AMBERGRIS; CLAVICEPS PURPUREA SCLEROTIUM; ZINC; SUS SCROFA THYMUS 800; 16; 18; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-029_27ad80da-a149-4bd5-8e6c-9ba057755151 66343-029 HUMAN OTC DRUG Emvita 17 QUININE ARSENATE, GRAPHITE, PULSATILLA VULGARIS, BARIUM CARBONATE, and THYROID, PORCINE LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG QUININE ARSENATE; GRAPHITE; PULSATILLA VULGARIS; BARIUM CARBONATE; THYROID, PORCINE 800; 18; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-030_668e5836-44b4-4d09-a1d1-17478d6d8598 66343-030 HUMAN OTC DRUG Emvita 18 AMANITA MUSCARIA FRUITING BODY, COPPER, IODINE, BUFO BUFO CUTANEOUS GLAND, and THYROID, PORCINE LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG AMANITA MUSCARIA FRUITING BODY; COPPER; IODINE; BUFO BUFO CUTANEOUS GLAND; THYROID, PORCINE 800; 18; 21; 21; 21 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-031_ae951e79-8b36-4c46-92e0-bdf831c9018e 66343-031 HUMAN OTC DRUG Emvita 19 Magnesium Carbonate, Zinc, Oyster Shell Calcium Carbonate, Crude, and Sus Scrofa Pituitary Gland LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG MAGNESIUM CARBONATE; ZINC; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SUS SCROFA PITUITARY GLAND 800; 18; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-032_4d4fe0a6-a377-4ac9-bd4b-8025bf00d93d 66343-032 HUMAN OTC DRUG Emvita 20 STRYCHNOS IGNATII SEED, APIS MELLIFERA, PHOSPHORUS, PULSATILLA VULGARIS, and LYTTA VESICATORIA LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG STRYCHNOS IGNATII SEED; APIS MELLIFERA; PHOSPHORUS; PULSATILLA VULGARIS; LYTTA VESICATORIA 16; 18; 21; 21; 21 [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-033_a041ecba-dee1-4b77-a843-188da50e7ee9 66343-033 HUMAN OTC DRUG Emvita 21 LACHESIS MUTA VENOM, MATRICARIA RECUTITA, MAGNESIUM CARBONATE, ARSENIC TRIOXIDE, and SUS SCROFA PITUITARY GLAND LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG LACHESIS MUTA VENOM; MATRICARIA RECUTITA; MAGNESIUM CARBONATE; ARSENIC TRIOXIDE; SUS SCROFA PITUITARY GLAND 800; 18; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-034_7b03fb58-de25-40d6-87f0-6efca3619b20 66343-034 HUMAN OTC DRUG Emvita 22 Matricaria Recutita, Iodine, Anacardium occidentale fruit, Crotalus horridus horridus venom, Phosphorus, Ambergris, and Sus scrofa pituitary gland LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG MATRICARIA RECUTITA; IODINE; ANACARDIUM OCCIDENTALE FRUIT; CROTALUS HORRIDUS HORRIDUS VENOM; PHOSPHORUS; AMBERGRIS; SUS SCROFA PITUITARY GLAND 800; 16; 18; 21; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-035_f88a70fd-479a-4e32-a52b-d526c8c4c0ff 66343-035 HUMAN OTC DRUG Emvita 23 COPPER, TOXICODENDRON PUBESCENS LEAF, AMANITA MUSCARIA FRUITING BODY, and SUS SCROFA PITUITARY GLAND LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG COPPER; TOXICODENDRON PUBESCENS LEAF; AMANITA MUSCARIA FRUITING BODY; SUS SCROFA PITUITARY GLAND 800; 18; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-036_98bc36d1-e739-4b12-9663-fb49436cfdff 66343-036 HUMAN OTC DRUG Emvita 24 CROTALUS HORRIDUS HORRIDUS VENOM, PHOSPHORUS, MATRICARIA RECUTITA, STRYCHNOS IGNATII SEED, and SUS SCROFA PITUITARY GLAND LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG CROTALUS HORRIDUS HORRIDUS VENOM; PHOSPHORUS; MATRICARIA RECUTITA; STRYCHNOS IGNATII SEED; SUS SCROFA PITUITARY GLAND 800; 16; 18; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-037_8bb62d2d-18aa-408a-922b-5fbc80c01d45 66343-037 HUMAN OTC DRUG Emvita 25 Conium Maculatum Flowering Top, Magnesium Carbonate, Apomorphine Hydrochloride, Lead, Lycopodium Clavatum Spore, and Sus Scrofa Cerebellum LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG CONIUM MACULATUM FLOWERING TOP; MAGNESIUM CARBONATE; APOMORPHINE HYDROCHLORIDE; LEAD; LYCOPODIUM CLAVATUM SPORE; SUS SCROFA CEREBELLUM 800; 16; 18; 21; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-038_ab558bd9-707a-4df9-8352-621305694754 66343-038 HUMAN OTC DRUG Emvita 26 Arsenic trioxide, Lycopodium clavatum spore, Lead, Achillea Millefolium, and Sus scrofa cerebellum LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; LEAD; ACHILLEA MILLEFOLIUM; SUS SCROFA CEREBELLUM 800; 16; 18; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-039_1af6b5ef-cb56-4fbb-8f35-6088db82f07c 66343-039 HUMAN OTC DRUG Emvita 27 Helleborus Niger Root, Mandragora Officinarum Root, Anacardium Occidentale Fruit, Lophophora Williamsii Flower, and Sus Scrofa Cerebellum LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG HELLEBORUS NIGER ROOT; MANDRAGORA OFFICINARUM ROOT; ANACARDIUM OCCIDENTALE FRUIT; LOPHOPHORA WILLIAMSII FLOWER; SUS SCROFA CEREBELLUM 800; 16; 18; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-040_1598a4c3-1a4d-40a2-b94f-25b11d579258 66343-040 HUMAN OTC DRUG Emvita 28 MANDRAGORA OFFICINARUM ROOT, HELLEBORUS NIGER ROOT, HYOSCYAMUS NIGER, AND SUS SCROFA CEREBELLUM LIQUID ORAL 20150507 UNAPPROVED HOMEOPATHIC RUBIMED AG MANDRAGORA OFFICINARUM ROOT; HELLEBORUS NIGER ROOT; HYOSCYAMUS NIGER; SUS SCROFA CEREBELLUM 800; 18; 21; 21 [hp_C]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 66343-041_7a7502b8-e8a7-4ea2-ba01-4b24027b7c0f 66343-041 HUMAN OTC DRUG Anxiovita Aconitum napellus, Cerebrum suis, Hypericum perforatum, Piper methysticum LIQUID ORAL 20180115 UNAPPROVED HOMEOPATHIC RUBIMED AG ACONITUM NAPELLUS; SUS SCROFA CEREBRUM; HYPERICUM PERFORATUM; PIPER METHYSTICUM ROOT 18; 200; 21; 12 [hp_M]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66348-4105_4ad5dd24-c826-4975-8682-8080fec442ad 66348-4105 HUMAN OTC DRUG CRC Sunscreen Towel CRC Sunscreen Towel CLOTH TOPICAL 20100301 OTC MONOGRAPH FINAL part352 CRC Industries, Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 20; 75; 40; 50 g/856mL; g/856mL; g/856mL; g/856mL E 20171231 66353-100_b2f5820a-d726-4a8c-9d8c-fed4d4d697dc 66353-100 HUMAN OTC DRUG Harmon Face Values Advanced Severe Dry Skin Therapy Petrolatum OINTMENT TOPICAL 20111121 OTC MONOGRAPH FINAL part347 Delta Pharma Inc. PETROLATUM 41 g/100g N 20181231 66353-200_6ea7d048-f495-45d9-b06f-e3f606f593ce 66353-200 HUMAN OTC DRUG Harmon Face Values Baby Healing Advanced Therapy Petrolatum OINTMENT TOPICAL 20120511 OTC MONOGRAPH FINAL part347 Delta Pharma Inc. PETROLATUM 41 g/100g E 20171231 66365-001_6121107b-a1d7-486c-a06e-a2b827ba1857 66365-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010601 NDA NDA205849 Medical Comfort Systems Inc OXYGEN 998 mL/L N 20181231 66382-003_e93b9abc-099f-4dca-b66d-68400554f416 66382-003 HUMAN OTC DRUG Vichy Normaderm Pore Unclogging Daily Scrub Salicylic Acid GEL TOPICAL 20120201 OTC MONOGRAPH FINAL part333D Laboratoires Industriels de Vichy (LIDV) SALICYLIC ACID .625 mL/125mL E 20171231 66382-005_b63eec47-7c3d-4252-94dc-330938ab150f 66382-005 HUMAN OTC DRUG Vichy Normaderm Daily deep cleansing Salicylic Acid GEL TOPICAL 20120201 OTC MONOGRAPH FINAL part333D Laboratoires Industriels de Vichy (LIDV) SALICYLIC ACID 1 mL/200mL E 20171231 66382-157_7f87a97d-0418-4156-97ad-50d29387d851 66382-157 HUMAN OTC DRUG La Roche-Posay Laboratoire Pharmacetique HydraPhase UV Eyes Hydrating Protective Cream SPF 29 Octinoxate Titanium dioxide LOTION TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 Laboratoires Industriels de Vichy (LIDV) OCTINOXATE; TITANIUM DIOXIDE 1.125; 1.14 mL/15mL; mL/15mL E 20171231 66382-222_874dcec4-35d9-4f60-a2e2-92205f688f12 66382-222 HUMAN OTC DRUG La Roche-Posay Laboratoire Dermatologique Anthelios 45 Ultra Light Sunscreen Fluid SPF 45 Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part352 Laboratoires Industriels de Vichy (LIDV) AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL E 20171231 66382-223_d8778a68-b76b-4bfb-801b-961b67f17b20 66382-223 HUMAN OTC DRUG La RochePosay Laboratoire Dermatologique Effaclar K Salicylic Acid Acne Treatment Salicylic acid LOTION TOPICAL 20110701 OTC MONOGRAPH FINAL part333D Laboratoires Industriels de Vichy (LIDV) SALICYLIC ACID .45 mL/30mL E 20171231 66382-299_9f47cf4b-da23-4516-95ab-efe193239312 66382-299 HUMAN OTC DRUG La Roche-Posay Laboratoire Dermatologique Anthelios 60 Ultra Light Sunscreen Fluid Avobenzone Homosalate Octisalate Octocrylene Oxybenzone LOTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part352 Laboratoires Industriels de Vichy (LIDV) AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 1.5; 7.5; 2.5; 2.5; 3 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL E 20171231 66382-542_7b3894e8-6a3e-4d87-917a-8b25b89b4fc0 66382-542 HUMAN OTC DRUG La Roche-Posay Laboratoire Pharmaceutique Rosaliac UV Fortifying Anti-Redness Moisturizer SPF 15 Avobenzone Octisalate Octocrylene LOTION TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 Laboratoires Industriels de Vichy (LIDV) AVOBENZONE; OCTISALATE; OCTOCRYLENE .8; 1.32; 1.848 mL/40mL; mL/40mL; mL/40mL E 20171231 66389-0001_10925f51-ce53-40db-a180-e5ec4e736268 66389-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010417 UNAPPROVED MEDICAL GAS Griffin Home Health Care, Inc. OXYGEN 99 L/100L E 20171231 66390-0001_a7ad812d-6aaf-44b2-a6a9-e106d44f05d3 66390-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000915 UNAPPROVED MEDICAL GAS Cache Valley Oxygen OXYGEN 99 L/100L E 20171231 66391-0046_0d2db50d-5660-4d9d-af2a-f2ec0a2cc900 66391-0046 HUMAN OTC DRUG Miracle of Aloe Rub Roll On Menthol LIQUID TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part348 Winning Solutions MENTHOL 1.8 mL/90mL E 20171231 66391-0301_5b156439-edab-40ec-bdfa-d46de0fc9534 66391-0301 HUMAN OTC DRUG Miracle Foot Repair Cream Menthol CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 Winning Solutions MENTHOL .224 g/224g E 20171231 66391-0303_fcd72628-595e-4318-830e-e9ff88be7663 66391-0303 HUMAN OTC DRUG Miracle Rash Repair Salicylic Acid CREAM TOPICAL 20051128 OTC MONOGRAPH FINAL part358H Winning Solutions SALICYLIC ACID 2.016 g/112g E 20171231 66391-0504_42072e37-eb03-4d14-a0c8-b80adb46832f 66391-0504 HUMAN OTC DRUG Miracle Foot Repair Menthol CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 Winning Solutions MENTHOL .028 g/28g E 20171231 66391-0603_ea76436a-7eff-4d45-afdc-448b7399fc17 66391-0603 HUMAN OTC DRUG Miracle Rub Menthol, Methyl Salicylate CREAM TOPICAL 20050201 OTC MONOGRAPH NOT FINAL part348 Winning Solutions MENTHOL; METHYL SALICYLATE 2.475; 9.9 g/99g; g/99g E 20171231 66391-0604_d68f0880-cec3-48aa-abc9-cbd9712b2448 66391-0604 HUMAN OTC DRUG Miracle Heel Repair Allantoin , Dimethicone CREAM TOPICAL 20090316 OTC MONOGRAPH NOT FINAL part347 Winning Solutions ALLANTOIN; DIMETHICONE 1.12; 1.12 g/112g; g/112g E 20171231 66391-0610_611b0f79-aba0-4489-8306-c823e383d308 66391-0610 HUMAN OTC DRUG Miracle Foot Repair Menthol CREAM TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part348 Winning Solutions MENTHOL .224 g/224g E 20171231 66403-308_2adf540d-c417-4f6f-bb20-4cb81535c7b6 66403-308 HUMAN OTC DRUG Tiger Balm Red Extra Strength Camphor (Synthetic) and Menthol OINTMENT TOPICAL 20020125 OTC MONOGRAPH NOT FINAL part348 Tiger Balm (Malaysia) Sdn. Bhd. CAMPHOR (SYNTHETIC); MENTHOL 110; 100 mg/g; mg/g N 20191231 66403-309_f1c4249a-f220-4da9-b208-5220c4b8d6e3 66403-309 HUMAN OTC DRUG Tiger Balm White Regular Strength Camphor (Synthetic) and Menthol OINTMENT TOPICAL 20020125 OTC MONOGRAPH NOT FINAL part348 Tiger Balm (Malaysia) Sdn. Bhd. CAMPHOR (SYNTHETIC); MENTHOL 110; 80 mg/g; mg/g N 20191231 66403-315_a09409ab-9c28-4745-b93f-4ff27e7de143 66403-315 HUMAN OTC DRUG Tiger Balm Ultra Strength Camphor (Synthetic) and Menthol OINTMENT TOPICAL 20020125 OTC MONOGRAPH NOT FINAL part348 Tiger Balm (Malaysia) Sdn. Bhd. CAMPHOR (SYNTHETIC); MENTHOL 110; 110 mg/g; mg/g N 20191231 66414-001_d69759ab-92bb-4abb-807b-b1a099c6e7a1 66414-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20031001 UNAPPROVED MEDICAL GAS Garland Welding Supply Company OXYGEN 992 mL/L E 20171231 66424-020_db28ac66-6fe4-4c73-8caa-b0e53c9a3006 66424-020 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 SDA Laboratories, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 66424-021_64e6c69b-2376-4107-bf8a-7264917b877e 66424-021 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 SDA Laboratories, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 66424-030_c7bb68e7-5479-467d-9fc0-fdf5a459486a 66424-030 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100915 OTC MONOGRAPH NOT FINAL part334 SDA Laboratories, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 66424-034_bfa490bf-965b-4d6d-94fe-5aef98ab6b09 66424-034 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20100519 OTC MONOGRAPH FINAL part341 SDA Laboratories, Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 66424-045_e00c89cf-22f2-4da7-b3d6-32962dc1de39 66424-045 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20120927 OTC MONOGRAPH FINAL part335 SDA Laboratories, Inc. BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 66424-396_729d0c91-8063-484e-b6d4-d110dd0aa93e 66424-396 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20160301 ANDA ANDA091239 SDA Laboratories, Inc. IBUPROFEN 200 mg/1 N 20181231 66424-399_dc14824e-7da5-4ca9-8627-37257ea0b002 66424-399 HUMAN OTC DRUG STOOL SOFTNER Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20160301 OTC MONOGRAPH NOT FINAL part334 SDA Laboratories, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 66424-562_2f10c016-9693-4a16-a09f-06d44fd204e3 66424-562 HUMAN OTC DRUG SENNA Syrup Sennosides A and B SYRUP ORAL 20150101 OTC MONOGRAPH NOT FINAL part334 SDA Laboratories, Inc. SENNOSIDES A AND B 8.8 mg/5mL N 20191231 66424-996_47cf8f81-1101-49bf-8e43-ed7761f1d1dd 66424-996 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20110127 ANDA ANDA075661 SDA Laboratories, Inc. IBUPROFEN 200 mg/1 N 20181231 66428-002_a9bbadd5-6e2d-4221-b508-a9719779b3ce 66428-002 HUMAN OTC DRUG TheradermSPF 43 SPF 43 Zinc Oxide, Octinoxate, Octisalate EMULSION TOPICAL 20120120 OTC MONOGRAPH FINAL part352 Therapon Skin Health, LP ZINC OXIDE; OCTINOXATE; OCTISALATE 7.5; 7.5; 2.5 mL/100mL; mL/100mL; mL/100mL E 20171231 66428-003_e4a89a61-d8f4-4549-94bf-b9d5f6aa8e41 66428-003 HUMAN OTC DRUG Reversion Acne Control Clarifying Cleanser salicylic acid LIQUID TOPICAL 20120907 OTC MONOGRAPH FINAL part333D Therapon Skin Health, LP SALICYLIC ACID 1 mL/100mL N 20181231 66428-004_a33debd0-2772-467c-9561-3ef9a32d6176 66428-004 HUMAN OTC DRUG Reversion Acne Control Clarifying Cleanser Face And Body salicylic acid LIQUID TOPICAL 20120907 OTC MONOGRAPH FINAL part333D Therapon Skin Health, LP SALICYLIC ACID 1 mL/100mL N 20181231 66428-005_a1444fb7-62a5-4890-ad5a-65f3cf161fa0 66428-005 HUMAN OTC DRUG Reversion Acne Control Purifying Toner salicylic acid LIQUID TOPICAL 20120907 OTC MONOGRAPH FINAL part333D Therapon Skin Health, LP SALICYLIC ACID 2 mL/100mL N 20181231 66428-006_b872ae97-15c0-4dfa-b63b-b79714602d3b 66428-006 HUMAN OTC DRUG Reversion Acne Control Spot Treatment PM benzoyl peroxide LIQUID TOPICAL 20120907 OTC MONOGRAPH FINAL part333D Therapon Skin Health, LP BENZOYL PEROXIDE 7.5 mL/100mL N 20181231 66428-007_336c1092-5c08-4801-8a98-5a3d69a65e84 66428-007 HUMAN OTC DRUG Instant Cool Skin Instant Relief. Sudden Results Lidocaine 0.5% LOTION TOPICAL 20150615 OTC MONOGRAPH NOT FINAL part348 Therapon Skin Health, LP LIDOCAINE .5 g/100mL E 20171231 66435-101_3e2fab44-f5d6-4d48-b534-f3f86309f358 66435-101 HUMAN PRESCRIPTION DRUG Ribasphere Ribavirin CAPSULE ORAL 20040407 ANDA ANDA076203 Kadmon Pharmaceuticals, LLC RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 66435-102_dffc1bdc-d81c-457e-ace7-ee5c6032f7b0 66435-102 HUMAN PRESCRIPTION DRUG RIBASPHERE ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 66435-103_dffc1bdc-d81c-457e-ace7-ee5c6032f7b0 66435-103 HUMAN PRESCRIPTION DRUG RIBASPHERE ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 66435-104_dffc1bdc-d81c-457e-ace7-ee5c6032f7b0 66435-104 HUMAN PRESCRIPTION DRUG RIBASPHERE ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 66435-105_dffc1bdc-d81c-457e-ace7-ee5c6032f7b0 66435-105 HUMAN PRESCRIPTION DRUG RIBASPHERE RibaPak ribavirin TABLET ORAL 20100101 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 66435-106_dffc1bdc-d81c-457e-ace7-ee5c6032f7b0 66435-106 HUMAN PRESCRIPTION DRUG RIBASPHERE RibaPak ribavirin KIT 20100101 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC N 20181231 66435-107_dffc1bdc-d81c-457e-ace7-ee5c6032f7b0 66435-107 HUMAN PRESCRIPTION DRUG RIBASPHERE RibaPak ribavirin TABLET ORAL 20100101 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 66435-108_dffc1bdc-d81c-457e-ace7-ee5c6032f7b0 66435-108 HUMAN PRESCRIPTION DRUG RIBASPHERE RibaPak ribavirin KIT 20120601 ANDA ANDA077456 Kadmon Pharmaceuticals, LLC N 20181231 66435-410_715620fb-614f-40b6-8d3d-8494843d8518 66435-410 HUMAN PRESCRIPTION DRUG Topotecan Hydrochloride topotecan hydrochloride INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20101202 ANDA ANDA091199 Three Rivers Pharmaceuticals, LLC. TOPOTECAN HYDROCHLORIDE 4 mg/4mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 66449-003_fd81c32e-24ab-40ba-a430-94f3464001c1 66449-003 HUMAN OTC DRUG Germicida Antimicrobial Triclosan SOAP TOPICAL 20120630 OTC MONOGRAPH NOT FINAL part333A Laboratorios Roldan, S.A. TRICLOSAN 1 g/100g E 20171231 66449-004_44912ec3-e2bc-4e51-a911-37639196b8bc 66449-004 HUMAN OTC DRUG Germicida Antimicrobial Triclosan SOAP TOPICAL 20120630 OTC MONOGRAPH NOT FINAL part333A Laboratorios Roldan, S.A. TRICLOSAN 2 g/100g E 20171231 66467-1081_3fff3b83-89de-4c1b-a7ac-e48f187a9daa 66467-1081 HUMAN PRESCRIPTION DRUG Hemal Aluminum Chloride Anhydrous SOLUTION DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply LLC ALUMINUM CHLORIDE ANHYDROUS 250 mg/g E 20171231 66467-2130_4beb0ec9-5399-0355-e054-00144ff88e88 66467-2130 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Sodium Fluoride GEL DENTAL 20101109 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC SODIUM FLUORIDE .0272 g/mL N 20181231 66467-2140_4bfdfc29-db0c-1351-e054-00144ff88e88 66467-2140 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Sodium Fluoride GEL DENTAL 20101112 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC SODIUM FLUORIDE .0272 g/mL N 20181231 66467-2150_4d023c7c-8c36-08a4-e054-00144ff88e88 66467-2150 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Sodium Fluoride GEL DENTAL 20101112 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC SODIUM FLUORIDE .0272 g/mL N 20181231 66467-2160_4beb0ec9-5391-0355-e054-00144ff88e88 66467-2160 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Sodium Fluoride GEL DENTAL 20101118 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC SODIUM FLUORIDE .0272 g/mL N 20181231 66467-2190_4bfdfc29-db14-1351-e054-00144ff88e88 66467-2190 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Sodium Fluoride GEL DENTAL 20101112 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC SODIUM FLUORIDE .0272 g/mL N 20181231 66467-2560_574d6d0a-a8cf-20f5-e053-2a91aa0a0877 66467-2560 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20060702 ANDA ANDA077789 Darby Dental Supply, LLC CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 66467-3000_9ca169b7-96d7-4669-9c07-ede8a1d8348f 66467-3000 HUMAN PRESCRIPTION DRUG BENZOCAINE Raspberry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 66467-3001_9ca169b7-96d7-4669-9c07-ede8a1d8348f 66467-3001 HUMAN PRESCRIPTION DRUG BENZOCAINE Bubble Gum Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 66467-3002_9ca169b7-96d7-4669-9c07-ede8a1d8348f 66467-3002 HUMAN PRESCRIPTION DRUG BENZOCAINE Cherry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 66467-3003_9ca169b7-96d7-4669-9c07-ede8a1d8348f 66467-3003 HUMAN PRESCRIPTION DRUG BENZOCAINE Mint Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 66467-3004_9ca169b7-96d7-4669-9c07-ede8a1d8348f 66467-3004 HUMAN PRESCRIPTION DRUG BENZOCAINE Pina Colada Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 66467-3006_9ca169b7-96d7-4669-9c07-ede8a1d8348f 66467-3006 HUMAN PRESCRIPTION DRUG BENZOCAINE Strawberry Benzocaine GEL, DENTIFRICE DENTAL 19630219 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] E 20171231 66467-3730_4d02d495-f980-1c56-e054-00144ff88e88 66467-3730 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Bubble Gum Sodium Fluoride AEROSOL, FOAM DENTAL 20120131 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC SODIUM FLUORIDE .0272 g/g N 20181231 66467-3760_4d025db7-3002-0a74-e054-00144ff88e88 66467-3760 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Mint Sodium Fluoride AEROSOL, FOAM DENTAL 20120131 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC SODIUM FLUORIDE .0272 g/g N 20181231 66467-3790_4d02a03c-2ffc-16ed-e054-00144ff88e88 66467-3790 HUMAN PRESCRIPTION DRUG Darby Topical Sodium Fluoride Strawberry Sodium Fluoride AEROSOL, FOAM DENTAL 20120131 UNAPPROVED DRUG OTHER Darby Dental Supply, LLC SODIUM FLUORIDE .0272 g/g N 20181231 66467-4000_b9acafc7-3fcb-4c55-ac3d-728afbfa207f 66467-4000 HUMAN OTC DRUG BENZOCAINE Raspberry Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Darby Dental Supply, LLC BENZOCAINE 220 mg/g E 20171231 66467-4001_b9acafc7-3fcb-4c55-ac3d-728afbfa207f 66467-4001 HUMAN OTC DRUG BENZOCAINE Bubble Gum Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Darby Dental Supply, LLC BENZOCAINE 220 mg/g E 20171231 66467-4002_b9acafc7-3fcb-4c55-ac3d-728afbfa207f 66467-4002 HUMAN OTC DRUG BENZOCAINE Cherry Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Darby Dental Supply, LLC BENZOCAINE 220 mg/g E 20171231 66467-4003_b9acafc7-3fcb-4c55-ac3d-728afbfa207f 66467-4003 HUMAN OTC DRUG BENZOCAINE Mint Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Darby Dental Supply, LLC BENZOCAINE 220 mg/g E 20171231 66467-4004_b9acafc7-3fcb-4c55-ac3d-728afbfa207f 66467-4004 HUMAN OTC DRUG BENZOCAINE Pina Colada Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Darby Dental Supply, LLC BENZOCAINE 220 mg/g E 20171231 66467-4006_b9acafc7-3fcb-4c55-ac3d-728afbfa207f 66467-4006 HUMAN OTC DRUG BENZOCAINE Strawberry Benzocaine GEL DENTAL 19630219 OTC MONOGRAPH NOT FINAL part356 Darby Dental Supply, LLC BENZOCAINE 220 mg/g E 20171231 66467-9710_e4991ad8-dc10-4df8-b02e-a5e2a685d255 66467-9710 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20110114 ANDA ANDA088389 Darby Dental Supply, LLC LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .02 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 66467-9730_a412809a-3fbc-4019-8ac6-d50f043deba9 66467-9730 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111215 ANDA ANDA088390 Darby Dental Supply, LLC LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 66467-9760_a7af30f8-9dc4-4b82-bfae-38760df12791 66467-9760 HUMAN PRESCRIPTION DRUG Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110114 ANDA ANDA088387 Darby Dental Supply, LLC MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 66467-9790_8ecc98b5-832a-4ae6-99bb-4484cfb2383f 66467-9790 HUMAN PRESCRIPTION DRUG Mepivacaine Hydrochloride and Levonordefrin Mepivacaine Hydrochloride and Levonordefrin INJECTION, SOLUTION SUBCUTANEOUS 20110114 ANDA ANDA088388 Darby Dental Supply, LLC MEPIVACAINE HYDROCHLORIDE; LEVONORDEFRIN 20; .05 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 66472-023_bdb98b7d-fcab-4704-9eb0-145ad4acfd9d 66472-023 HUMAN OTC DRUG Benefit Triple Performing Facial Emulsion Broad Spectrum SPF 15 AVOBENZONE, OCTOCRYLENE, OCTINOXATE, SULISOBENZONE EMULSION TOPICAL 20110728 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC AVOBENZONE; OCTOCRYLENE; OCTINOXATE; SULISOBENZONE 30; 20; 74.9; 15 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 66472-024_61054043-79c4-7222-e053-2991aa0a7551 66472-024 HUMAN OTC DRUG BENEFIT HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - Im So Glamber OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL N 20181231 66472-025_61054043-7a00-7222-e053-2991aa0a7551 66472-025 HUMAN OTC DRUG BENEFIT HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - Im All The Rage OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL N 20181231 66472-026_61050932-dacd-22ad-e053-2a91aa0a67a7 66472-026 HUMAN OTC DRUG BENEFIT HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - CHEERS TO ME OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL N 20181231 66472-027_61054043-7a1d-7222-e053-2991aa0a7551 66472-027 HUMAN OTC DRUG BENEFIT HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - Im Hopelessly Hot OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL N 20181231 66472-028_61054043-7a2b-7222-e053-2991aa0a7551 66472-028 HUMAN OTC DRUG BENEFIT HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - IM SO MONEY OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL N 20181231 66472-029_61054043-7a3a-7222-e053-2991aa0a7551 66472-029 HUMAN OTC DRUG BENEFIT HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - BELIEVE IN ME OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL N 20181231 66472-030_61050932-dadb-22ad-e053-2a91aa0a67a7 66472-030 HUMAN OTC DRUG BENEFIT HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - IM PURE 4 SURE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL N 20181231 66472-031_61050932-dae9-22ad-e053-2a91aa0a67a7 66472-031 HUMAN OTC DRUG BENEFIT HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - GOTTA KNOW ME OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL N 20181231 66472-032_61050932-db15-22ad-e053-2a91aa0a67a7 66472-032 HUMAN OTC DRUG BENEFIT HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - IM PLUSH AND PRECIOUS OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 54.9; 23.7 mg/mL; mg/mL N 20181231 66472-033_610599c0-1e8e-66ad-e053-2a91aa0aacae 66472-033 HUMAN OTC DRUG BENEFIT HELLO FLAWLESS OXYGEN WOW Broad Spectrum SPF 25 BRIGHTENING MAKEUP - WARM ME UP OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20111020 OTC MONOGRAPH FINAL part352 Benefit Cosmetics, LLC TITANIUM DIOXIDE; OCTINOXATE 23.7; 54.9 mg/mL; mg/mL N 20181231 66472-034_61f80c9f-fbca-555d-e053-2991aa0a36cd 66472-034 HUMAN OTC DRUG Benefit BOO BOO ZAP Medicated Acne Treatment SALICYLIC ACID GEL TOPICAL 20111229 OTC MONOGRAPH FINAL part333D Benefit Cosmetics, LLC SALICYLIC ACID 5 mg/mL N 20191231 66472-035_6107ce4f-fc56-ee97-e053-2991aa0ab557 66472-035 HUMAN OTC DRUG benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 01 FAIR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20131113 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 50; 47 mg/mL; mg/mL; mg/mL N 20181231 66472-036_6107aff5-a56c-1b21-e053-2a91aa0af862 66472-036 HUMAN OTC DRUG benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 02 LIGHT OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20131112 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 50; 47 mg/mL; mg/mL; mg/mL N 20181231 66472-037_df160bf9-783e-42f4-a88d-2c79b0aa0482 66472-037 HUMAN OTC DRUG benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 03 LIGHTMEDIUM OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20131113 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 50; 47 mg/mL; mg/mL; mg/mL N 20181231 66472-038_cb516c71-be03-485e-9f64-65d636cd1559 66472-038 HUMAN OTC DRUG benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 04 MEDIUM OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20131113 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 50; 47 mg/mL; mg/mL; mg/mL N 20181231 66472-039_d7f85768-152e-4ff0-8665-00bc966917ec 66472-039 HUMAN OTC DRUG benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 05 BEIGE OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20131113 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 50; 47 mg/mL; mg/mL; mg/mL N 20181231 66472-040_f5aae0e4-979c-4be1-aa27-b26abe6e4f21 66472-040 HUMAN OTC DRUG benefit BIG EASY BROAD SPECTRUM SPF 35 SUNSCREEN multi-balancing complexion perfector - 06 DEEP BEIGE OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20131113 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 50; 50; 47 mg/mL; mg/mL; mg/mL N 20181231 66472-041_c9916abf-6d8e-48f6-99c5-d9a8fa2357ed 66472-041 HUMAN OTC DRUG benefit DREAM SCREEN BROAD SPECTRUM SPF 45 SUNSCREEN FOR FACE AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20131112 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 66472-042_27fb39f4-bb0b-5ef4-e054-00144ff88e88 66472-042 HUMAN OTC DRUG BENEFIT Air Patrol Broad Spectrum SPF20 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC OCTINOXATE; TITANIUM DIOXIDE 59.9; 21.9 mg/mL; mg/mL N 20181231 66472-043_27fb0e83-ce65-58f2-e054-00144ff88e88 66472-043 HUMAN OTC DRUG BENEFIT Triple Performing Facial Broad Spectrum SPF15 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, SULISOBENZONE CREAM TOPICAL 20150822 OTC MONOGRAPH NOT FINAL part352 Benefit Cosmetics, LLC AVOBENZONE; OCTINOXATE; OCTOCRYLENE; SULISOBENZONE 30; 74.9; 20; 15 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 66487-001_298d76db-65f7-436a-a3fe-9b97ef005bc6 66487-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19990109 NDA NDA205840 ROBINSON`S INDUSTRIAL GAS & EQUIPMENT CORP. OXYGEN 997 mL/L N 20181231 66487-002_94ba5f8c-c392-4931-b7a9-0b34902a83c9 66487-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen LIQUID RESPIRATORY (INHALATION) 20100901 NDA NDA205839 ROBINSON`S INDUSTRIAL GAS & EQUIPMENT CORP. NITROGEN 997 mL/L N 20181231 66490-041_e5d790c0-7211-46d7-bde6-ddb4130888d3 66490-041 HUMAN PRESCRIPTION DRUG D.H.E. 45 Dihydroergotamine Mesylate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20011003 NDA NDA005929 Valeant Pharmaceuticals North America DIHYDROERGOTAMINE MESYLATE 1 mg/mL Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient] N 20181231 66490-555_0eaf76d9-ccdb-4345-a49e-1d939153f445 66490-555 HUMAN OTC DRUG Sunscreen SPF 50 CeraVe Titanium Dioxide - 4.90% Zinc Oxide - 4.70% LOTION TOPICAL 20121212 OTC MONOGRAPH NOT FINAL part352 Valeant Pharmaceuticals TITANIUM DIOXIDE; ZINC OXIDE 4.9; 4.7 g/100g; g/100g N 20181231 66490-650_0cd4f002-9977-47b5-a928-20984cc7d4bb 66490-650 HUMAN PRESCRIPTION DRUG Diastat diazepam GEL RECTAL 19970729 NDA NDA020648 Valeant Pharmaceuticals North America LLC DIAZEPAM 2.5 mg/.5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 66490-690_8e3319b6-61dd-4243-a9cf-b5acc34358ad 66490-690 HUMAN PRESCRIPTION DRUG Mysoline Primidone TABLET ORAL 20090624 NDA NDA009170 Valeant Pharmaceuticals North America PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 66490-691_8e3319b6-61dd-4243-a9cf-b5acc34358ad 66490-691 HUMAN PRESCRIPTION DRUG Mysoline Primidone TABLET ORAL 20090624 NDA NDA009170 Valeant Pharmaceuticals North America PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 66492-001_af10af47-1dff-450b-833d-9b39385e8007 66492-001 HUMAN OTC DRUG FLU TERMINATOR DROPS Gelsemium, Zincum gluconicum, Zincum metallicum, Aconitum napellus, Eupatorium perfoliatum, Sulphur, Phosphorus, Asclepias vincetoxicum, Influenzinum, Anas barbariae. LIQUID ORAL 20000101 UNAPPROVED HOMEOPATHIC Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics GELSEMIUM SEMPERVIRENS ROOT; ZINC GLUCONATE; ZINC; ACONITUM NAPELLUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; SULFUR; PHOSPHORUS; CYNANCHUM VINCETOXICUM ROOT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 3; 3; 3; 4; 4; 4; 5; 6; 12; 12; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 66492-004_91a435fb-1968-4caf-8643-ecb47973d3ad 66492-004 HUMAN OTC DRUG SINUS Pulsatilla, Euphorbium, Allium Cepa, Histaminum, Luffa Operculata, Sabadilla, Hepar Sulfur. LIQUID NASAL 20170901 UNAPPROVED HOMEOPATHIC Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics PULSATILLA VULGARIS; EUPHORBIA RESINIFERA RESIN; ONION; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED; CALCIUM SULFIDE 2; 4; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66492-005_9f0fbc7a-8a22-456f-85ab-77c68f005c99 66492-005 HUMAN OTC DRUG Headek Nasal Belladonna, Glonoinum, Coffea, Natrum Carb, Natrum Mur. SPRAY NASAL 20110222 UNAPPROVED HOMEOPATHIC Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics ATROPA BELLADONNA; NITROGLYCERIN; ARABICA COFFEE BEAN; SODIUM CARBONATE; SODIUM CHLORIDE 3; 6; 6; 6; 12 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 66492-006_62e1ae2d-4483-4315-b9b4-3afde2f1f0f3 66492-006 HUMAN OTC DRUG ALLERGY DROPS Apis mellifica, Apisinum, Allium cepa, Euphrasia, Sabadilla, Euphorbium, Pulsatilla, Hedera helix, Histaminum. LIQUID ORAL 20000101 UNAPPROVED HOMEOPATHIC Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics APIS MELLIFERA; APIS MELLIFERA VENOM; ONION; EUPHRASIA STRICTA; SCHOENOCAULON OFFICINALE SEED; EUPHORBIA RESINIFERA RESIN; PULSATILLA VULGARIS; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE 2; 12; 3; 3; 3; 6; 6; 4; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66492-008_5a81e2d7-bbc0-4714-996d-601205c9c4d1 66492-008 HUMAN OTC DRUG Stress Drops Cimicifuga racemosa, Gelsemium, Hypericum, Staphysagria, Ignatia amara, Kali bromatum, Kali phosphoricum, Moschus, Lachesis mutus, Pulsatilla. LIQUID SUBLINGUAL 20130716 UNAPPROVED HOMEOPATHIC Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics BLACK COHOSH; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; DELPHINIUM STAPHISAGRIA SEED; STRYCHNOS IGNATII SEED; POTASSIUM BROMIDE; DIBASIC POTASSIUM PHOSPHATE; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; LACHESIS MUTA VENOM; ANEMONE PULSATILLA 3; 3; 3; 3; 4; 6; 6; 6; 12; 12 [hp_X]/58.5mL; [hp_X]/58.5mL; [hp_X]/58.5mL; [hp_X]/58.5mL; [hp_X]/58.5mL; [hp_X]/58.5mL; [hp_X]/58.5mL; [hp_X]/58.5mL; [hp_X]/58.5mL; [hp_X]/58.5mL N 20181231 66492-038_f5eeeea0-bd86-493f-8d0e-fcc576ad01e9 66492-038 HUMAN OTC DRUG Lung Drops Belladonna, Ipecacuanha, Lobelia Inflata, Quebracho, Antimonium Tartaricum, Blatta Orientalis, Naphthalinum, Natrum Sulphuricum, Pulsatilla, Rumex Crispus, Mercurius Solubilis, Adrenalinum. LIQUID SUBLINGUAL 20141125 UNAPPROVED HOMEOPATHIC Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics ATROPA BELLADONNA; IPECAC; LOBELIA INFLATA; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; ANTIMONY POTASSIUM TARTRATE; BLATTA ORIENTALIS; NAPHTHALENE; SODIUM SULFATE; ANEMONE PULSATILLA; RUMEX CRISPUS ROOT; MERCURIUS SOLUBILIS; EPINEPHRINE 4; 4; 4; 5; 6; 6; 6; 6; 6; 6; 8; 5 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL N 20181231 66492-069_b9680f5a-f4ad-4c8d-9dda-a7e69ad1b1f8 66492-069 HUMAN OTC DRUG Arnica Well Bellis Perennis, Calendula Officinalis, Hamamelis Virginiana, Millefollium MT, Chamomilla, Ferrum Phosphoricum, Ledum Palustre, Magnesia Phosphorica, Apis Mellifica, Arnica Montana, Belladonna, Symphytum Officinale, Hypericum Perforatum. GEL TOPICAL 20130818 UNAPPROVED HOMEOPATHIC Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics 052584997 BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACHILLEA MILLEFOLIUM; MATRICARIA CHAMOMILLA; FERROSOFERRIC PHOSPHATE; RHODODENDRON TOMENTOSUM LEAFY TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; COMFREY ROOT; HYPERICUM PERFORATUM 1; 1; 1; 1; 1; 2; 2; 2; 3; 3; 3; 4; 6 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 66492-245_26298b44-b41e-49dc-b384-5d486d2b5ae6 66492-245 HUMAN OTC DRUG Arnica Plus DROPS Aconitum napellus, Arnica montana, Chamomilla, Hypericum perforatum, Ruta graveolens, Symphytum officinale, Belladonna, Colocynthis, Rhus tox, Ferrum phos, Magnesium phos. LIQUID ORAL 20000101 UNAPPROVED HOMEOPATHIC Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics ACONITUM NAPELLUS; ARNICA MONTANA; MATRICARIA RECUTITA; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT; ATROPA BELLADONNA; CITRULLUS COLOCYNTHIS FRUIT PULP; TOXICODENDRON PUBESCENS LEAF; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC 3; 3; 3; 3; 3; 3; 4; 4; 6; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66492-260_9ae5a27b-c5f4-4360-bc8f-c1a6c78a52ed 66492-260 HUMAN OTC DRUG Phase 6 Drops Taraxacum Off, Galium Aparine, Thuja, Aloe, Phytolacca, Euphorbium Officinarum, Zincum Metallicum, Arsenicum Album, Viscum Album, Conium Maculatum, Histaminum Hydrochloricum, Formicum Acidum LIQUID ORAL 20170901 UNAPPROVED HOMEOPATHIC Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics TARAXACUM OFFICINALE; GALIUM APARINE; THUJA OCCIDENTALIS LEAFY TWIG; ALOE; PHYTOLACCA AMERICANA ROOT; EUPHORBIA RESINIFERA RESIN; ZINC; ARSENIC TRIOXIDE; VISCUM ALBUM FRUITING TOP; CONIUM MACULATUM FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; FORMIC ACID 1; 1; 3; 3; 3; 6; 6; 6; 8; 30; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 66497-0001_d5b80023-ce5c-472c-bc7b-63aad334c839 66497-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020613 UNAPPROVED MEDICAL GAS Boll Medical Inc. OXYGEN 99 L/100L E 20171231 66506-180_62660347-6a17-12b9-e053-2a91aa0aaf80 66506-180 HUMAN OTC DRUG Tibetree Pain Relieveing Plaster camphor PLASTER TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part348 Tibet Cheezheng Tibetan Medicine Co. Ltd. CAMPHOR (NATURAL) 1 g/100g N 20191231 66506-181_d3ea5494-00a7-4fa1-a469-eed5a06e5d01 66506-181 HUMAN OTC DRUG Cheezheng Pain Relieving Camphor (Natural) PATCH TOPICAL 20130120 OTC MONOGRAPH FINAL part348 Tibet Cheezheng Tibetan Medicine Co. Ltd. CAMPHOR (NATURAL) 13.875 mg/h E 20171231 66506-182_2673004f-68f4-01df-e054-00144ff8d46c 66506-182 HUMAN OTC DRUG CheeZheng Pain Relieveing Plaster camphor PLASTER TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part348 Tibet Cheezheng Tibetan Medicine Co. Ltd. CAMPHOR (NATURAL) 1 g/100g N 20181231 66513-220_08d58a1a-c769-4209-b83d-2c792a991d96 66513-220 HUMAN OTC DRUG Bronco Rub Camphor Eucalyptus Menthol OINTMENT TOPICAL 20140815 OTC MONOGRAPH FINAL part341 Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g N 20181231 66513-222_4d1e7e82-c8e8-4d94-915c-26b3616b5335 66513-222 HUMAN OTC DRUG Broncolin Camphor Menthol OINTMENT TOPICAL 20110615 OTC MONOGRAPH FINAL part341 Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V. CAMPHOR (NATURAL); MENTHOL 5.3; 2.8 g/100g; g/100g E 20171231 66513-382_3c01ae38-6c2b-4d15-a9f2-06a74ad751d8 66513-382 HUMAN OTC DRUG Tussin CF Non Drowsy Multi Symptom Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20170430 OTC MONOGRAPH FINAL part341 Broncolin S.A de C.V. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 66513-468_cfe5fe12-8696-49ea-b272-3b37e799ff95 66513-468 HUMAN OTC DRUG Broncolin Cold and Flu Relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20160430 OTC MONOGRAPH FINAL part341 Broncolin S.A de C.V. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 66521-000_176a9876-f0ac-461b-b5c9-a50bb5572250 66521-000 VACCINE FLUAD INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) and INFLUENZA B VIRUS B/BRISBANE/9/2014 ANTIGEN (FORMALDEHYDE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20151124 BLA BLA125510 Novartis Vaccines and Diagnostics Limited INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/9/2014 ANTIGEN (FORMALDEHYDE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL E 20171231 66521-118_ef92ae97-084f-43bb-b589-a24858fcc35c 66521-118 VACCINE Fluvirin INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013, NIB-88 (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 - WILD TYPE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) INJECTION, SUSPENSION INTRAMUSCULAR 20150701 BLA BLA103837 Novartis Vaccines and Diagnostics Limited INFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SWITZERLAND/9715293/2013 NIB-88 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL E 20171231 66521-200_04366dc0-ba66-11de-a487-0002a5d5c51b 66521-200 VACCINE Influenza A (H1N1) 2009 Monovalent Vaccine Influenza A (H1N1) 2009 Monovalent Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20090915 BLA BLA103837 Novartis Vaccines and Diagnostics Ltd INFLUENZA A VIRUS A/CALIFORNIA/7/2009(H1N1)-LIKE HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug/.5mL E 20171231 66530-249_ebef744f-ba8b-4177-9ecc-408c8dc1907c 66530-249 HUMAN PRESCRIPTION DRUG FLUOROURACIL fluorouracil CREAM TOPICAL 20080411 ANDA ANDA077524 Spear Dermatology Products FLUOROURACIL 50 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 66530-252_fa405c67-23bd-46f5-bb8b-5b3c8d1bdf5c 66530-252 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil CREAM TOPICAL 20150423 ANDA ANDA203122 Spear Dermatology Products FLUOROURACIL 5 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 66530-253_76aaa12e-66e2-4eea-bd0b-35255b1e547d 66530-253 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA019049 Spear Dermatology Products Inc TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 66530-254_76aaa12e-66e2-4eea-bd0b-35255b1e547d 66530-254 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA017522 Spear Dermatology Products Inc TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 66530-255_76aaa12e-66e2-4eea-bd0b-35255b1e547d 66530-255 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CREAM TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA017340 Spear Dermatology Products Inc TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 66530-256_76aaa12e-66e2-4eea-bd0b-35255b1e547d 66530-256 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA017955 Spear Dermatology Products Inc TRETINOIN .1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 66530-257_76aaa12e-66e2-4eea-bd0b-35255b1e547d 66530-257 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20140206 NDA AUTHORIZED GENERIC NDA017579 Spear Dermatology Products Inc TRETINOIN .25 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 66530-258_41b7c43d-1935-4d3a-83f0-ee5b02b8ba83 66530-258 HUMAN PRESCRIPTION DRUG Fluorouracil fluorouracil CREAM TOPICAL 20141028 NDA AUTHORIZED GENERIC NDA020985 Spear Dermatology Products Inc FLUOROURACIL 5 mg/g Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 66530-259_7c6d3fe6-d7a1-47f9-b6ce-c4af56b98376 66530-259 HUMAN PRESCRIPTION DRUG Tretinoin Gel Microsphere Tretinoin GEL TOPICAL 20141001 NDA AUTHORIZED GENERIC NDA020475 Spear Dermatology Products Inc TRETINOIN .4 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 66530-260_7c6d3fe6-d7a1-47f9-b6ce-c4af56b98376 66530-260 HUMAN PRESCRIPTION DRUG Tretinoin Gel Microsphere Tretinoin GEL TOPICAL 20141001 NDA AUTHORIZED GENERIC NDA020475 Spear Dermatology Products Inc TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 66530-262_267249c2-2e25-4f59-a996-a96c8642c83b 66530-262 HUMAN PRESCRIPTION DRUG Tretinoin Gel Tretinoin GEL TOPICAL 20150901 ANDA ANDA207955 Spear Dermatology Products TRETINOIN .05 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 66538-001_02592368-3e78-4759-9271-e0e9ac38c779 66538-001 HUMAN OTC DRUG SUN SAVVY SOLAR SHIELD ZINC OXIDE TITANIUM DIOXIDE LOTION TOPICAL 20110326 OTC MONOGRAPH NOT FINAL part352 CRC (Cosmoceutical Research Center) ZINC OXIDE; TITANIUM DIOXIDE 5; 5 g/100mL; g/100mL N 20181231 66538-101_0d05aa9c-d555-49af-a01d-5dc373378dfc 66538-101 HUMAN OTC DRUG SUNSCREEN SPF 28 OCTINOXATE ZINC OXIDE CREAM TOPICAL 20111128 OTC MONOGRAPH NOT FINAL part352 COSMOCEUTICAL RESEARCH CENTER INC OCTINOXATE; ZINC OXIDE 7.5; 6 g/100g; g/100g N 20181231 66538-201_e6657b8d-def5-427c-948f-111495cacae9 66538-201 HUMAN OTC DRUG LIGHTENER HYDROQUINONE CREAM TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part358A CRC (Cosmoceutical Research Center) HYDROQUINONE 1.9 g/100g N 20181231 66538-301_4d4670cb-bb74-4963-adfc-9b2998d26ef4 66538-301 HUMAN PRESCRIPTION DRUG ANESTHETIC LIDOCAINE HYDROCHLORIDE BENZOCAINE GEL TOPICAL 20120218 OTC MONOGRAPH NOT FINAL part348 COSMOCEUTICAL RESEARCH CENTER INC LIDOCAINE HYDROCHLORIDE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 66538-401_8a1cd6a6-a46a-4e43-8cf1-30bc52e76559 66538-401 HUMAN OTC DRUG NUJEVI ACNE BENZOYL PEROXIDE CREAM TOPICAL 20140828 OTC MONOGRAPH FINAL part333D COSMOCEUTICAL RESEARCH CENTER INC BENZOYL PEROXIDE 2.5 g/100g N 20181231 66538-501_5bbfbcf1-593e-492e-aee3-28de5e14f57d 66538-501 HUMAN PRESCRIPTION DRUG Trichloroacetic Acid 15% Trichloroacetic Acid LIQUID TOPICAL 20140924 UNAPPROVED DRUG OTHER CRC (Cosmoceutical Research Center) TRICHLOROACETIC ACID 15 g/100mL N 20181231 66538-502_fd77c44e-de53-4b66-a80b-b3a1b909df34 66538-502 HUMAN PRESCRIPTION DRUG Trichloroacetic Acid 30% Trichloroacetic Acid LIQUID TOPICAL 20140924 UNAPPROVED DRUG OTHER CRC (Cosmoceutical Research Center) TRICHLOROACETIC ACID 30 g/100mL N 20181231 66538-503_3c82e330-6c10-4cc9-860b-5bf8d205228e 66538-503 HUMAN PRESCRIPTION DRUG Trichloroacetic Acid 50% Trichloroacetic Acid LIQUID TOPICAL 20140924 UNAPPROVED DRUG OTHER CRC (Cosmoceutical Research Center) TRICHLOROACETIC ACID 30 g/100mL N 20181231 66552-0001_7ced7f77-b265-41c9-9a61-921172f46632 66552-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010711 UNAPPROVED MEDICAL GAS Alpine Home Medical Equipment OXYGEN 99 L/100L E 20171231 66556-1945_1ed95ed4-f05a-3ff1-e054-00144ff8d46c 66556-1945 HUMAN OTC DRUG Hand E San Ethanol LIQUID TOPICAL 20010801 OTC MONOGRAPH NOT FINAL part333E Birko Corporation ALCOHOL .71 L/L N 20181231 66559-1471_02028bea-3836-46d2-af7b-b5c7868985c9 66559-1471 HUMAN OTC DRUG Amazing Face Skin Balancing Flexible Coverage Foundation Octisalate and Octinoxate POWDER TOPICAL 20100517 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTISALATE; OCTINOXATE .27; .45 g/9g; g/9g E 20171231 66559-1472_02028bea-3836-46d2-af7b-b5c7868985c9 66559-1472 HUMAN OTC DRUG Amazing Face Skin Balancing Flexible Coverage Foundation Octisalate and Octinoxate POWDER TOPICAL 20100517 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTISALATE; OCTINOXATE .27; .45 g/9g; g/9g E 20171231 66559-1473_02028bea-3836-46d2-af7b-b5c7868985c9 66559-1473 HUMAN OTC DRUG Amazing Face Skin Balancing Flexible Coverage Foundation Octisalate and Octinoxate POWDER TOPICAL 20100517 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTISALATE; OCTINOXATE .27; .45 g/9g; g/9g E 20171231 66559-1474_02028bea-3836-46d2-af7b-b5c7868985c9 66559-1474 HUMAN OTC DRUG Amazing Face Skin Balancing Flexible Coverage Foundation Octisalate and Octinoxate POWDER TOPICAL 20100517 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTISALATE; OCTINOXATE .27; .45 g/9g; g/9g E 20171231 66559-1475_02028bea-3836-46d2-af7b-b5c7868985c9 66559-1475 HUMAN OTC DRUG Amazing Face Skin Balancing Flexible Coverage Foundation Octisalate and Octinoxate POWDER TOPICAL 20100517 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTISALATE; OCTINOXATE .27; .45 g/9g; g/9g E 20171231 66559-2977_6dcdd70a-6b2f-477f-8f91-189a9c32089a 66559-2977 HUMAN OTC DRUG No7 CC LIGHT Octocrylene and Octinoxate EMULSION TOPICAL 20140501 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTOCRYLENE; OCTINOXATE 80; 75 mg/mL; mg/mL E 20171231 66559-2978_6dcdd70a-6b2f-477f-8f91-189a9c32089a 66559-2978 HUMAN OTC DRUG No7 CC MEDIUM Octocrylene and Octinoxate EMULSION TOPICAL 20140501 OTC MONOGRAPH FINAL part352 Cosmetica Laboratories Inc. OCTOCRYLENE; OCTINOXATE 80; 75 mg/mL; mg/mL E 20171231 66579-0008_4ff9b5d9-3430-4a92-8240-9d8e4aa64eb1 66579-0008 HUMAN OTC DRUG Tremor Plex Agaricus muscarius, Argentum nitricum, Aurum sulphuratum, Causticum, Gelsemium sempervirens, Heloderma, Hyoscyamus niger, Manganum aceticum, Mercurius solubilis, Stramonium, Zincum metallicum LIQUID ORAL 20140821 UNAPPROVED HOMEOPATHIC New Sun Inc. AMANITA MUSCARIA FRUITING BODY; SILVER NITRATE; GOLD MONOSULFIDE; CAUSTICUM; GELSEMIUM SEMPERVIRENS ROOT; HELODERMA HORRIDUM VENOM; HYOSCYAMUS NIGER; MANGANESE ACETATE TETRAHYDRATE; MERCURIUS SOLUBILIS; DATURA STRAMONIUM; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0009_90c87a4a-c448-4bcd-96d0-043842fe68b3 66579-0009 HUMAN OTC DRUG Sleep Eezzz Aconitum napellus, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Passiflora incarnata, Pulsatilla, Valeriana officinalis LIQUID ORAL 20140730 UNAPPROVED HOMEOPATHIC New Sun Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; ATROPA BELLADONNA; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0010_3563d170-e38f-4916-816d-304fe5b78073 66579-0010 HUMAN OTC DRUG Acne Clear Antimonium tartaricum, Asterias rubens, Ferrum metallicum, Hepar sulphuris calcareum, Kali bromatum, Natrum muriaticum, Sanguinaria canadensis, Selenium metallicum, Sepia, Silicea, Sulphur, thuja occidentalis LIQUID ORAL 20100721 UNAPPROVED HOMEOPATHIC New Sun Inc. ANTIMONY POTASSIUM TARTRATE; ASTERIAS RUBENS; IRON; CALCIUM SULFIDE; POTASSIUM BROMIDE; SODIUM CHLORIDE; SANGUINARIA CANADENSIS ROOT; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0013_9a881380-886b-445a-941f-5938729aac41 66579-0013 HUMAN OTC DRUG Detox and Drainage, Blood and Kidney Arsenicum album, Baptisia tinctoria, Carbo vegetabilis, Chininum sulphuricum, Cinchona officinalis, Conium maculatum, Echinacea purpurea, Ferrum metallicum, Hydrastis canadensis, Kali chloricum, Mercurius corrosivus, Serum anguillae LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC New Sun Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ACTIVATED CHARCOAL; QUININE SULFATE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; IRON; GOLDENSEAL; POTASSIUM CHLORATE; MERCURIC CHLORIDE; ANGUILLA ROSTRATA BLOOD SERUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0014_dc78cf98-45f0-4af6-af8c-51b890e32013 66579-0014 HUMAN OTC DRUG Detox and Drainage, Liver Arsenicum album, Baptisia tinctoria, Berberis vulgaris, Bryonia, Carduus marianus, Chelidonium majus, Chionanthus virginica, Cinchona officinalis, Lycopodium clavatum Manganum muriaticum, Natrum sulphuricum, Nux vomica, Phosphorus, Sulphur, Taraxacum officinale LIQUID ORAL 20140730 UNAPPROVED HOMEOPATHIC New Sun Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; MILK THISTLE; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; LYCOPODIUM CLAVATUM SPORE; MANGANESE CHLORIDE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SULFUR; TARAXACUM OFFICINALE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0018_edf85228-abd3-4f67-8a53-48fdc8678e26 66579-0018 HUMAN OTC DRUG Stress and Anxiety Aconitum napellus, Apis mellifica, Arnica montana, Arsenicum album, Belladonna, Bellis perennis, Bryonia, Calendula officinalis, Chamomilla, Cistus canadensis, Clematis erecta, Ferrum phosphoricum, Histaminum hydrochloricum, Hypericum perforatum, Ignatia amara, Impatiens glandulifera, flos, Ornithogalum umbellatum, Passiflora incarnata, Phosphorus, Prunus cerasifera, flos, Rhus toxicodendron, Sulphur, Symphytum officinale, Veratrum album LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC New Sun Inc. ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS CERASIFERA FLOWER; TOXICODENDRON PUBESCENS LEAF; SULFUR; COMFREY ROOT; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0019_5f89edcb-2acc-4c97-9117-1eef01c0eee9 66579-0019 HUMAN OTC DRUG Acute Viro Reliever Aconitum napellus, Belladonna, Chininum sulphuricum, Ferrum phosphoricum, Hepar sulphuris calcareum, Mercurius corrosivus, Natrum muriaticum, Nux vomica, Phosphorus, Pulsatilla, Sarcolacticum acidum, Sulphur LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC New Sun Inc. ACONITUM NAPELLUS; ATROPA BELLADONNA; QUININE SULFATE; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; MERCURIC CHLORIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; LACTIC ACID, L-; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0023_35127dbb-ea5f-43d6-8577-423e42ed883e 66579-0023 HUMAN OTC DRUG Bacterial Reliever Allium sativum, Arsenicum album, Baptisia tinctoria, Belladonna, Echinacea purpurea, Eucalyptus globulus, Hydrastis canadensis, Lac caninum, Myristica sebifera, Myrtus communis, Phosphorus, Phytolacca decandra LIQUID ORAL 20140917 UNAPPROVED HOMEOPATHIC New Sun Inc. GARLIC; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; ECHINACEA PURPUREA; EUCALYPTUS GLOBULUS LEAF; GOLDENSEAL; CANIS LUPUS FAMILIARIS MILK; MYRTUS COMMUNIS TOP; VIROLA SEBIFERA RESIN; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0026_da840a58-8724-4b2c-b0f6-2d3c698fd793 66579-0026 HUMAN OTC DRUG Sinus Relief Apis mellifica, Baptisia tinctoria, Colocythis, Hepar sulphuris calcareum, Histaminum hydrochloricum, Hydrastis canadensis, Ignatia amara, Kali bichromicum, Lemna minor, Mercurius vivus, Pulsatilla, Rhus toxicodendron, Sabadilla, Thuja occidentalis LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC New Sun Inc. APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LEMNA MINOR; MERCURY; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0028_4662f6d8-2b3a-4f2d-8d1a-4662a3514eb6 66579-0028 HUMAN OTC DRUG Back, Neck, Muscle, and Joint Injuries Relief Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Sepia, Zincum metallicum LIQUID ORAL 20140908 UNAPPROVED HOMEOPATHIC New Sun Inc. HORSE CHESTNUT; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; BLACK COHOSH; COBALT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OXALIC ACID DIHYDRATE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SEPIA OFFICINALIS JUICE; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0035_19c534c3-9c21-4b24-9e1e-4b477a8e0835 66579-0035 HUMAN OTC DRUG Allergies Southern US Adenosinun cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum Mucosa nasalis suis, Nasturtium aquaticum, Natrum muriaticum, Rhus toxicodendron, RNA, Sabadilla, Sassafras officinale LIQUID ORAL 20140730 UNAPPROVED HOMEOPATHIC New Sun Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; ALNUS SERRULATA BARK; CENTAUREA BENEDICTA; CHICORY ROOT; CORTISONE ACETATE; MUCUNA PRURIENS FRUIT TRICHOME; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; NASTURTIUM OFFICINALE; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SASSAFRAS ALBIDUM ROOT BARK 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL N 20181231 66579-0036_442f8b16-ae69-4015-afb5-807cf61f32d1 66579-0036 HUMAN OTC DRUG Allergies Total Mold Control Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Asarum canadense, Cortisone aceticum, Eupatorium aromaticum, Euphrasia officinalis, Fraxinus americana, Galphimia glauca, Helianthus annuus, Histaminum hydrochloricum, Juniperus virginiana, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Plantago major, RNA, Rumex crispus, Sabadilla, Senecio jacobaea LIQUID ORAL 20140804 UNAPPROVED HOMEOPATHIC New Sun Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; ONION; CORTICOTROPIN; ASARUM CANADENSE ROOT; CORTISONE ACETATE; AGERATINA AROMATICA ROOT; EUPHRASIA STRICTA; FRAXINUS AMERICANA BARK; GALPHIMIA GLAUCA FLOWERING TOP; HELIANTHUS ANNUUS FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PLANTAGO MAJOR; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; JACOBAEA VULGARIS 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL N 20181231 66579-0037_3fd0b083-1d2b-4d50-bd50-c431b4567599 66579-0037 HUMAN OTC DRUG Allergies Northeastern US Adenosinum cyclophosphoricum, Adren alinum, Adrenocorticotrophin, Agraphis nutans, allium cepa, Collinsonia canadensis, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Salvia officinalis, Tanacetum vulgare, Trifolium pratense, Vinca minor LIQUID ORAL 20120417 UNAPPROVED HOMEOPATHIC New Sun Inc. ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; HYACINTHOIDES NON-SCRIPTA; ONION; COLLINSONIA CANADENSIS ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; SAGE; TANACETUM VULGARE TOP; TRIFOLIUM PRATENSE FLOWER; VINCA MINOR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL N 20181231 66579-0038_bab037fb-8655-45b1-864f-a871981800c6 66579-0038 HUMAN OTC DRUG Allergies Total Mold Control Arsenicum album, Baptisia tinctoria, Chloramphenicolum, Echinacea, Elaeis guineensis, Hydrastis canadensis, Hydrastis canadensis, Mercurius solubilis, Myrrha, Nasturtium aquaticum, Nux vomica, Phosphorus, Phytolacca decandra, Pulsatilla, Ricinus communis, Sepia, Xanthoxylum fraxineum LIQUID ORAL 20140805 UNAPPROVED HOMEOPATHIC New Sun Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CHLORAMPHENICOL; ECHINACEA, UNSPECIFIED; ELAEIS GUINEENSIS FRUIT; GOLDENSEAL; MERCURIUS SOLUBILIS; MYRRH; NASTURTIUM OFFICINALE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RICINUS COMMUNIS SEED; SEPIA OFFICINALIS JUICE; ZANTHOXYLUM AMERICANUM BARK 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL N 20181231 66579-0049_78d9a6c6-4bba-49c5-ac0d-716f38dcd5a8 66579-0049 HUMAN OTC DRUG Calm Aconitum napellus, Alfalfa, Argentum nitricum, Avena sativa, Chamomilla, Gelsemium sempervirens, Glonoinum, Histaminum hydrochloricum, Ignatia amara, Kali phosphoricum, Passiflora incarnata, Phosphorus, Veratrum album LIQUID ORAL 20140729 UNAPPROVED HOMEOPATHIC New Sun Inc. ACONITUM NAPELLUS; ALFALFA; SILVER NITRATE; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; HISTAMINE DIHYDROCHLORIDE; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL N 20181231 66579-0055_b46b5e93-2d25-497b-9482-20a75633d2a1 66579-0055 HUMAN OTC DRUG Bio Reset Jet Lag/Shift Change Cocculus indicus, Colchicum autumnale, Gelsemium sempervirens, Juniperus communis, Kali carbonicum, Kali phosphoricum Nux vomica, Passiflora incarnata, Phosphoricum acidum, Phosphorus LIQUID ORAL 20110106 UNAPPROVED HOMEOPATHIC New Sun Inc. ANAMIRTA COCCULUS SEED; COLCHICUM AUTUMNALE BULB; GELSEMIUM SEMPERVIRENS ROOT; JUNIPER BERRY; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; PHOSPHORUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0056_0cc79cbd-3d99-4133-b3fe-2967d977805d 66579-0056 HUMAN OTC DRUG ICV Toxi Formula Antimonium crudum, Arsenicum album, Cinchona officinalis, Colocynthis, Gambogia, Gentiana lutea, Magnesia phosphorica, Natrum sulphuricum, Nux vomica, Phosphorus LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC New Sun Inc. ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; GAMBOGE; GENTIANA LUTEA ROOT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0057_a0313141-41db-43b0-b885-9d78c5b5ca31 66579-0057 HUMAN OTC DRUG Gout Symptom Reliever Ammonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, Urtica urens LIQUID ORAL 20140829 UNAPPROVED HOMEOPATHIC New Sun Inc. AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR BARK; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0058_286ae8df-bed4-4800-b3a0-c33a4d13a455 66579-0058 HUMAN OTC DRUG Detox and Drainage, Lymph Belladonna, Calcarea iodata, Conium maculatum, Echinacea purpurea, Hepar sulphuris calcareum, Kali iodatum, Kali muriaticum, Mercurius vivus, Phytolacca decandra, Pulsatilla, Ricinus communis, Scrophularia nodosa, Solidago virgaurea, Sulphur iodatum, LIQUID ORAL 20140908 UNAPPROVED HOMEOPATHIC New Sun Inc. ATROPA BELLADONNA; CALCIUM IODIDE; CONIUM MACULATUM FLOWERING TOP; ECHINACEA PURPUREA; CALCIUM SULFIDE; POTASSIUM IODIDE; POTASSIUM CHLORIDE; MERCURY; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RICINUS COMMUNIS SEED; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; SULFUR IODIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0060_cdbc07f9-6bfc-4c39-893c-0fb6ba1a4607 66579-0060 HUMAN OTC DRUG Headache Relief II Gelsemium sempervirens, Glonoinum, Iris versicolor, Kali carbonicum, Lycopodium clavatum, Natrum muriaticum, Niccolum metallicum, Nux vomica, Sanguinaria canadensis, Secale cornutum, Spigelia anthelmia, Sulphur LIQUID ORAL 20110428 UNAPPROVED HOMEOPATHIC New Sun Inc. GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; NICKEL; STRYCHNOS NUX-VOMICA SEED; SANGUINARIA CANADENSIS ROOT; CLAVICEPS PURPUREA SCLEROTIUM; SPIGELIA ANTHELMIA; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0061_e86d9c4d-d19e-41b2-88d4-fd95fb9c33e2 66579-0061 HUMAN OTC DRUG Yeast Freee Abies nigra, Antimonium crudum, Asafoetida, Baptisia tinctoria, Borax, Candida albicans, Lachesis mutus, Phytolacca decandra, Phosphoricum acidum, Pulsatilla, Sticta pulmonaria, Sulphur, Thuja occidentalis LIQUID ORAL 20140819 UNAPPROVED HOMEOPATHIC New Sun Inc. PICEA MARIANA RESIN; ANTIMONY TRISULFIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; SODIUM BORATE; CANDIDA ALBICANS; LACHESIS MUTA VENOM; PHYTOLACCA AMERICANA ROOT; PHOSPHORIC ACID; PULSATILLA VULGARIS; LOBARIA PULMONARIA; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0064_68510a4a-d5ed-40e9-b3cd-6d4a4f9e1cfd 66579-0064 HUMAN OTC DRUG Constitutional Immuno Aconitum napellus, Arsenicum album,Baryta carbonica, Bryonia, Calcarea carbonica, Cantharis, Gelsemium sempervirens, Graphites, Hydrastis canadensis, Kali carbonicum, Lachesis mutus, Lycopodium clavatum, Mercurius vivus, Natrum muriaticum, Nux vomica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhus toxicodendron, Sepia, Silicea, Sulphur LIQUID ORAL 20140730 UNAPPROVED HOMEOPATHIC New Sun Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYTTA VESICATORIA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; GOLDENSEAL; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0065_cf980642-bf60-4308-bd7b-84f441d897f3 66579-0065 HUMAN OTC DRUG Allergies Foundational Formula Adenosinum cyclophosphoricum, Adrenocorticotrophin, Allium cepa, Arsenicum album, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Sabadilla LIQUID ORAL 20140716 UNAPPROVED HOMEOPATHIC New Sun Inc. ADENOSINE CYCLIC PHOSPHATE; CORTICOTROPIN; ONION; ARSENIC TRIOXIDE; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL; [hp_X]/29mL N 20181231 66579-0067_9825b009-6638-4a73-89df-849e0eeb4b60 66579-0067 HUMAN OTC DRUG Lungs and Bronchial Relief Ammonium carbonicum, Antimonium arsenicicum, Antimonium tartaricum, Arsenicum album, Bromium, Carbo vegetabilis, Chlorinum, Kali carbonicum, Lobelia inflata, Stannum metallicum, Sulphuricum acidum LIQUID ORAL 20140717 UNAPPROVED HOMEOPATHIC New Sun Inc. AMMONIUM CARBONATE; ANTIMONY ARSENATE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BROMINE; ACTIVATED CHARCOAL; CHLORINE; POTASSIUM CARBONATE; LOBELIA INFLATA; TIN; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0069_c2f87820-19f7-4679-902b-8e6e74cd4b8f 66579-0069 HUMAN OTC DRUG Anti-Aging and Wrinkles Abrotanum, Anacardium orientale, Arsenicum album, Baryta Carbonica, Baryta muriatica, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Ferrum metallicum, Fucus vesiculosus, Hekla lava, Helleborus niger, Ignatia amara, Lycopodium clavatum, Nicotinamidum, Secale cornutum, Silicea LIQUID ORAL 20140729 UNAPPROVED HOMEOPATHIC New Sun Inc. ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; HEKLA LAVA; HELLEBORUS NIGER ROOT; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0070_77460a04-b411-4236-8cdf-1dcc4704227e 66579-0070 HUMAN OTC DRUG Weight and Appetite Control Abies canadensis, Ammonium bromatum, Ammonium muriaticum, Anacardium orientale, Antimonium crudum, Argentum metallicum, Calcarea carbonica, Capsicum annuum, Cinchona officinalis, Ferrum metallicum, Fucus vesiculosus, Ignatia amara, Kali bichromicum, Lycopodium clavatum, Mercurius solubilis, Natrum sulphuricum, Oleander, Phosphorus, Phytolacca decandra, Sabadilla, Staphysagria, Sulphur, Thyroidinum, Veratrum album LIQUID ORAL 20110824 UNAPPROVED HOMEOPATHIC New Sun Inc. TSUGA CANADENSIS BARK; TSUGA CANADENSIS FLOWER BUD; AMMONIUM BROMIDE; AMMONIUM CHLORIDE; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CINCHONA OFFICINALIS BARK; IRON; FUCUS VESICULOSUS; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM SULFATE; NERIUM OLEANDER LEAF; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THYROID, UNSPECIFIED; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0075_5d98074b-6d44-485a-816e-121b9043879c 66579-0075 HUMAN OTC DRUG Smoke Freee Arsenicum album, Caladium seguinum, Carbolicum acidum, Daphne indica, Eugenia jambosa, Kali phosphoricum, Lobelia inflata, Nicotinum, Nux vomica, Plantago major, Saccharum officinale, Staphysagria, Tabacum, Thuja occidentalis LIQUID ORAL 20120202 UNAPPROVED HOMEOPATHIC New Sun Inc. ARSENIC TRIOXIDE; DIEFFENBACHIA SEGUINE; PHENOL; DAPHNE ODORA BARK; SYZYGIUM JAMBOS SEED; POTASSIUM PHOSPHATE, DIBASIC; LOBELIA INFLATA; NICOTINE; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; SUCROSE; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0078_f14cff3e-b098-4bcd-b349-896c98c064af 66579-0078 HUMAN OTC DRUG Bladder Incontinence Formula Belladonna, Bellis perennis, Benzoicum acidum, Benzoicum acidum, Causticum, Equisetum hyemale, Lycopodium clavatum, Phosphorus, Plantago major, Rhus aromatica, Sepia LIQUID ORAL 20140905 UNAPPROVED HOMEOPATHIC New Sun Inc. ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0079_e915d6b6-3b00-430c-82e2-18b1f187c9d6 66579-0079 HUMAN OTC DRUG Allergy and Red Eye Relief Aconitum napellus, Allium cepa, Ambrosia artemisiaefolia, Apis mellifica, arsenicum album, Belladonna, Cactus grandiflorus, Dulcamara, Euphrasia officinalis, Gelsemium sempervirens, Graphites, Hamamelis virginiana, Hepar sulphuris calcareum, Kali iodatum, Mercurius vivus, Natrum muriaticum, Pulsatilla, Rhus toxicodendron, Ruta graveolens, Sabadilla, Sulphur, Thuja occidentalis, Zincum metallicum LIQUID ORAL 20141020 UNAPPROVED HOMEOPATHIC New Sun Inc. ACONITUM NAPELLUS; ONION; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; SELENICEREUS GRANDIFLORUS STEM; SOLANUM DULCAMARA TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; POTASSIUM IODIDE; MERCURY; SODIUM CHLORIDE; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0080_c5335667-d8ef-4a77-b161-23f6fc099c18 66579-0080 HUMAN OTC DRUG Menopause Amyl nitrosum, Calcarea carbonica, Caulophyllum thalictroides, Cimicifuga racemosa, Ferrum metallicum, Gelsemium sempervirens, Lachesis mutus, Pulsatilla, Sanguinaria canadensis, Sepia, Sulphur, Sulphuricum acidum LIQUID ORAL 20120222 UNAPPROVED HOMEOPATHIC New Sun Inc. AMYL NITRITE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAULOPHYLLUM THALICTROIDES ROOT; BLACK COHOSH; IRON; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT; SEPIA OFFICINALIS JUICE; SULFUR; SULFURIC ACID 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66579-0090_18089f3e-d601-4140-a539-49256ab77a25 66579-0090 HUMAN OTC DRUG Colds and Flu/Multi Symptom Reliever Arsenicum album, Baptisia tinctoria, Bryonia, Dulcamara, Echinacea, Echinacea purpurea, Eupatorium purpureum, Ferrum phosphoricum, Gelsemium sempervirens, Kali muriaticum, Phosphorus, Pulsatilla, Sulphur, Zincum aceticum, Zincum carbonicum, Zincum metallicum, Zincum muriaticum, Zincum oxydatum, Zincum picricum, Zincum valerianicum LIQUID ORAL 20140820 UNAPPROVED HOMEOPATHIC New Sun Inc. ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; SOLANUM DULCAMARA TOP; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; FERROSOFERRIC PHOSPHATE; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR; ZINC ACETATE ANHYDROUS; ZINC CARBONATE; ZINC; ZINC CHLORIDE; ZINC OXIDE; ZINC PICRATE NONAHYDRATE; ZINC VALERATE DIHYDRATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 66582-311_fe4838bc-c614-4555-872c-37b179d8c233 66582-311 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Merck Sharp & Dohme Corp. EZETIMIBE; SIMVASTATIN 10; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 66582-312_fe4838bc-c614-4555-872c-37b179d8c233 66582-312 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Merck Sharp & Dohme Corp. EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 66582-313_fe4838bc-c614-4555-872c-37b179d8c233 66582-313 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Merck Sharp & Dohme Corp. EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 66582-315_fe4838bc-c614-4555-872c-37b179d8c233 66582-315 HUMAN PRESCRIPTION DRUG VYTORIN ezetimibe and simvastatin TABLET ORAL 20040723 NDA NDA021687 Merck Sharp & Dohme Corp. EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 66582-414_7e4a2893-1fea-4609-828e-c69f147fde57 66582-414 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20021025 NDA NDA021445 Merck Sharp & Dohme Corp. EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 66586-1073_3bfe5567-9570-427d-9297-e51bb2b0fd07 66586-1073 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20050101 UNAPPROVED MEDICAL GAS Merwin Home Medical dba Robin Drup Corp. OXYGEN 99 L/100L E 20171231 66594-321_43da4965-15ef-4716-95a6-ea67a636ae43 66594-321 HUMAN OTC DRUG PRO-CHLO Chlophedianol Hydrochloride, Phenylephrine Hydrochloride, Pyrilamine Maleate LIQUID ORAL 20111212 OTC MONOGRAPH FINAL part341 Pro-Pharma, LLC CHLOPHEDIANOL HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 12.5; 5; 12.5 mg/5mL; mg/5mL; mg/5mL E 20171231 66594-333_a63ff20f-e825-4b62-b7e1-775ec3ab4b80 66594-333 HUMAN OTC DRUG PRO-CLEAR AC Codeine Phosphate and Pyrilamine Maleate SYRUP ORAL 20080908 OTC MONOGRAPH FINAL part341 Pro-Pharma LLC CODEINE PHOSPHATE; PYRILAMINE MALEATE 9; 8.33 mg/5mL; mg/5mL CV E 20171231 66594-499_cc958709-6208-4ae0-8d57-2361bf78d826 66594-499 HUMAN OTC DRUG PRO-RED AC Codeine Phosphate, Dexchorpheniramine Maleate, Phenylephrine Hydrochloride SYRUP ORAL 20130930 OTC MONOGRAPH FINAL part341 Pro-Pharma, LLC CODEINE PHOSPHATE; DEXCHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 9; 1; 5 mg/5mL; mg/5mL; mg/5mL CV E 20171231 66608-207_4c6dbe44-ad09-7032-e054-00144ff88e88 66608-207 HUMAN OTC DRUG Instant Foaming Hand Sanitizer Benzalkonium chloride SOAP TOPICAL 20170404 OTC MONOGRAPH NOT FINAL part333A Kimball Midwest BENZALKONIUM CHLORIDE .0026 mg/100mL N 20181231 66608-515_46c1ccb5-6129-4585-99f0-80f3539f1d0d 66608-515 HUMAN OTC DRUG Vindicator Instant Hand Sanitizer alcohol GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 Kimball Midwest ALCOHOL 600 mL/1000mL E 20171231 66611-123_28c1ea39-62b2-005b-e054-00144ff8d46c 66611-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130523 UNAPPROVED MEDICAL GAS Performance Modalities Inc dba Performance Home Medical OXYGEN 99 L/100L E 20171231 66613-8148_192916da-ac7a-455b-8e60-e934b75f8369 66613-8148 HUMAN OTC DRUG Rohto Hydra Hydroxyethyl cellulose LIQUID OPHTHALMIC 20110103 20181031 OTC MONOGRAPH FINAL part349 Rohto Pharmaceutical Co. Ltd. HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) 6 mg/mL N 20181231 66621-0150_c8f00dc0-684c-4389-86d5-b566709205f1 66621-0150 PLASMA DERIVATIVE ANASCORP CENTRUROIDES (Scorpion) IMMUNE F(ab)2 (EQUINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110803 BLA BLA125335 Rare Disease Therapeutics, Inc CENTRUROIDES FAB2 ANTIVENIN (EQUINE) 24 mg/mL Antivenin [EPC],Passively Acquired Immunity [PE],Venom Neutralization [MoA],Antivenins [Chemical/Ingredient] N 20181231 66621-0790_1b2f3aba-d32a-4112-9acd-46d969d47ff2 66621-0790 PLASMA DERIVATIVE ANAVIP Crotalidae Immune F(ab)2(Equine) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150506 BLA BLA125488 Rare Disease Theraputics, Inc PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE) 24 mg/mL N 20181231 66621-4000_d797121e-e13a-41b8-b7d7-e104ba26077c 66621-4000 HUMAN PRESCRIPTION DRUG Cystadane betaine POWDER, FOR SOLUTION ORAL 19961025 NDA NDA020576 Rare Disease Therapeutics, Inc. BETAINE 6 g/1 Methylating Activity [MoA],Methylating Agent [EPC] N 20181231 66653-100_2fe57dca-9611-6f20-e054-00144ff8d46c 66653-100 HUMAN OTC DRUG Pain Relief Cream Pain Relief Cream CREAM TOPICAL 20160405 OTC MONOGRAPH NOT FINAL part348 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. CAMPHOR (NATURAL) 1 g/100g E 20171231 66658-102_91356576-97d6-4093-a193-0bd1f0a1bcbf 66658-102 HUMAN PRESCRIPTION DRUG Orfadin Nitisinone CAPSULE ORAL 20160701 NDA NDA021232 SWEDISH ORPHAN BIOVITRUM AB (PUBL) NITISINONE 2 mg/1 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 66658-105_91356576-97d6-4093-a193-0bd1f0a1bcbf 66658-105 HUMAN PRESCRIPTION DRUG Orfadin Nitisinone CAPSULE ORAL 20160701 NDA NDA021232 SWEDISH ORPHAN BIOVITRUM AB (PUBL) NITISINONE 5 mg/1 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 66658-110_91356576-97d6-4093-a193-0bd1f0a1bcbf 66658-110 HUMAN PRESCRIPTION DRUG Orfadin Nitisinone CAPSULE ORAL 20160701 NDA NDA021232 SWEDISH ORPHAN BIOVITRUM AB (PUBL) NITISINONE 10 mg/1 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 66658-112_f5a852da-1b94-4f48-a4c9-7737dc814d03 66658-112 HUMAN PRESCRIPTION DRUG Kepivance palifermin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091215 BLA BLA125103 Swedish Orphan Biovitrum AB (publ) PALIFERMIN 6.25 mg/1.2mL Fibroblast Growth Factor 7 [Chemical/Ingredient],Increased Epithelial Proliferation [PE],Mucocutaneous Epithelial Cell Growth Factor [EPC] N 20181231 66658-120_91356576-97d6-4093-a193-0bd1f0a1bcbf 66658-120 HUMAN PRESCRIPTION DRUG Orfadin Nitisinone CAPSULE ORAL 20160701 NDA NDA021232 SWEDISH ORPHAN BIOVITRUM AB (PUBL) NITISINONE 20 mg/1 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 66658-204_aebb1cd4-3770-4843-adaa-d503797060d3 66658-204 HUMAN PRESCRIPTION DRUG ORFADIN nitisinone SUSPENSION ORAL 20160601 NDA NDA206356 Swedish Orphan Biovitrum AB (publ) NITISINONE 4 mg/mL 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 66658-234_23568233-c1c2-4eb7-be9e-881cf32c85c5 66658-234 HUMAN PRESCRIPTION DRUG Kineret anakinra INJECTION, SOLUTION SUBCUTANEOUS 20091215 BLA BLA103950 Swedish Orphan Biovitrum AB (publ) ANAKINRA 100 mg/.67mL Interleukin 1 Receptor Antagonists [MoA],Interleukin-1 Receptor Antagonist [EPC] N 20181231 66663-103_eea6a0b9-3f5f-4726-a59d-63d36cbe78f3 66663-103 HUMAN PRESCRIPTION DRUG AVC Vaginal sulfanilamide CREAM VAGINAL 19650605 NDA NDA006530 Jazz Pharmaceuticals Commercial Corp. SULFANILAMIDE 15 g/100g N 20181231 66663-219_693eb049-72dc-4a8b-92b9-5bbd65c058c2 66663-219 HUMAN PRESCRIPTION DRUG Urelle hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate TABLET ORAL 20020101 UNAPPROVED DRUG OTHER Jazz Pharmaceuticals Commercial Corp. HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .12; 81; 10.8; 32.4; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1 N 20181231 66672-001_187abe7b-ba6a-4a73-af38-249cf5655d6b 66672-001 HUMAN OTC DRUG AU KAH CHUEN ANTIFUNGAL Clotrimazole LOTION TOPICAL 20170508 OTC MONOGRAPH FINAL part333C GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD CLOTRIMAZOLE 1 g/100mL N 20181231 66685-1001_5d116209-2091-475a-aa25-a7b1bee0d74e 66685-1001 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021121 ANDA ANDA065093 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 66685-1002_5d116209-2091-475a-aa25-a7b1bee0d74e 66685-1002 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021127 ANDA ANDA065117 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 66685-1011_5d116209-2091-475a-aa25-a7b1bee0d74e 66685-1011 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20040813 ANDA ANDA065098 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 66685-1012_5d116209-2091-475a-aa25-a7b1bee0d74e 66685-1012 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20040813 ANDA ANDA065098 Sandoz Inc AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 66689-008_a66ca6f7-ae72-4074-bb7b-56d3187e6115 66689-008 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20120501 ANDA ANDA065422 VistaPharm, Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 66689-009_45471b6a-07c5-4303-8108-65ae35718276 66689-009 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20120816 ANDA ANDA074978 VistaPharm, Inc. IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66689-020_df2d1fe3-3a4b-4d50-9abf-52b51b9c93a2 66689-020 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20120822 ANDA ANDA075671 VistaPharm, Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 66689-023_7e6f57bd-c6d1-4055-9382-c68b02c201e8 66689-023 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 20170105 ANDA ANDA200343 VistaPharm, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 66689-025_0875aa1b-b0ac-498f-b862-e3e695fa1bbc 66689-025 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20120815 ANDA ANDA202537 VistaPharm, Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 66689-028_3802e015-d1cc-43ae-9144-42e8f4d49c70 66689-028 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam SOLUTION ORAL 20100125 ANDA ANDA078976 VistaPharm, Inc LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 66689-031_5bfdb665-609b-4e92-bbc6-2a21b91b77fb 66689-031 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride SOLUTION ORAL 20100212 ANDA ANDA075051 VistaPharm, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 66689-032_b8f4c055-2074-45f5-8c0b-6172a770cb65 66689-032 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20120301 ANDA ANDA201947 VistaPharm, Inc. MORPHINE SULFATE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 66689-033_b8f4c055-2074-45f5-8c0b-6172a770cb65 66689-033 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20120301 ANDA ANDA201947 VistaPharm, Inc. MORPHINE SULFATE 20 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 66689-036_b6653765-ed02-473c-b5b1-1ac71dde7dc2 66689-036 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20100510 ANDA ANDA040342 VistaPharm, Inc. PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 66689-037_db1ca470-d0d8-400d-a35b-c5a4c7d23f3d 66689-037 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20100510 ANDA ANDA064142 VistaPharm, Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 66689-038_55b271b9-a4d7-4cf9-8f8f-037562fcf434 66689-038 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 20100510 ANDA ANDA074138 VistaPharm, Inc. LACTULOSE 20 g/30mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 66689-039_55b271b9-a4d7-4cf9-8f8f-037562fcf434 66689-039 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 20100510 ANDA ANDA074138 VistaPharm, Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 66689-047_8beb2c8b-f304-49b9-833f-898cc13f3494 66689-047 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride SOLUTION ORAL 20150215 NDA NDA206814 VistaPharm, Inc. POTASSIUM CHLORIDE 20 meq/15mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 66689-048_8beb2c8b-f304-49b9-833f-898cc13f3494 66689-048 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride SOLUTION ORAL 20150215 NDA NDA206814 VistaPharm, Inc. POTASSIUM CHLORIDE 40 meq/30mL Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 66689-063_68431e29-5369-42dd-bef3-f8e636184a48 66689-063 HUMAN PRESCRIPTION DRUG Donnatal phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide ELIXIR ORAL 20171026 UNAPPROVED DRUG OTHER VistaPharm, Inc. PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 66689-100_1068513f-5256-4591-8ee7-f31458b95069 66689-100 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol SYRUP ORAL 20160907 NDA AUTHORIZED GENERIC NDA077788 VistaPharm, Inc. ALBUTEROL 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 66689-201_1bcaa6a7-39a8-4ba7-a0c2-522655b31d29 66689-201 HUMAN OTC DRUG INSTA-CHAR AQUEOUS POISON TREATMENT ADSORBENT SUSPENSION ORAL 20061003 OTC MONOGRAPH NOT FINAL part357 VistaPharm, Inc. ACTIVATED CHARCOAL 50 g/240mL N 20181231 66689-202_11965494-d0c0-442d-b021-4afd340efb5e 66689-202 HUMAN OTC DRUG INSTA-CHAR AQUEOUS CHERRY POISON ADSORBENT SUSPENSION ORAL 20071211 OTC MONOGRAPH NOT FINAL part357 VistaPharm, Inc. ACTIVATED CHARCOAL 50 g/240mL N 20181231 66689-203_809ea15f-836a-4da7-81ea-51b6eae4a1f8 66689-203 HUMAN OTC DRUG INSTA-CHAR SORBITOL POISON ADSORBENT SUSPENSION ORAL 20080328 OTC MONOGRAPH NOT FINAL part357 VistaPharm, Inc. ACTIVATED CHARCOAL 50 g/240mL N 20181231 66689-401_44ecedba-cf68-30a6-e054-00144ff8d46c 66689-401 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20161228 NDA NDA201194 VistaPharm, Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 66689-403_44ecedba-cf68-30a6-e054-00144ff8d46c 66689-403 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20161228 NDA NDA201194 VistaPharm, Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 66689-694_307d6454-1d79-4af7-8fb4-933ac5e1d190 66689-694 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride CONCENTRATE ORAL 20091030 ANDA ANDA040088 VistaPharm, Inc. METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 66689-695_307d6454-1d79-4af7-8fb4-933ac5e1d190 66689-695 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride CONCENTRATE ORAL 20170329 ANDA ANDA040088 VistaPharm, Inc. METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 66689-710_d052763b-5de2-42af-8a9d-e909aba9f044 66689-710 HUMAN OTC DRUG Kerr 100 Triple Dye Dispos-A proflavine hemisulfate, Brilliant Green, and Gentian Violet SWAB TOPICAL 20040501 OTC MONOGRAPH NOT FINAL part333A VistaPharm, Inc. PROFLAVINE HEMISULFATE; BRILLIANT GREEN; GENTIAN VIOLET 1.14; 2.29; 2.2 mg/mL; mg/mL; mg/mL N 20181231 66689-711_a626e8cb-ac96-44fb-b7fb-4ea5373c9234 66689-711 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride SOLUTION ORAL 20100801 ANDA ANDA090707 VistaPharm, Inc. METHADONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 66689-712_a626e8cb-ac96-44fb-b7fb-4ea5373c9234 66689-712 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride SOLUTION ORAL 20100801 ANDA ANDA090707 VistaPharm, Inc. METHADONE HYDROCHLORIDE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 66689-775_020a0ad5-f054-487b-aea4-f4e8d8d82a8a 66689-775 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin SUSPENSION ORAL 20170329 ANDA ANDA040610 VistaPharm, Inc. PHENYTOIN 125 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 66689-790_e22473c3-9989-4a01-b884-db58d621d5d0 66689-790 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate SUSPENSION ORAL 20120816 NDA NDA019183 VistaPharm, Inc. SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 66689-810_9e558696-2ed9-4778-a94e-dd0f132a6de9 66689-810 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 19980529 ANDA ANDA040241 VistaPharm, Inc. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 66689-820_4c8b541c-33e8-4969-b258-af150808d46e 66689-820 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 19980529 ANDA ANDA040241 VistaPharm, Inc. METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 66689-898_e3131c15-5be1-401d-8e01-14bd48034921 66689-898 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 19980325 ANDA ANDA075082 VistaPharm, Inc. METHADONE HYDROCHLORIDE 40 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 66694-001_29695452-f329-4875-aa6a-1d46f23b2d77 66694-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Procaire, LLC OXYGEN 99 L/100L E 20171231 66715-0370_47490c5d-225f-4737-a165-0defc419918b 66715-0370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20151122 OTC MONOGRAPH NOT FINAL part333A Lil' Drug Store Products, Inc ALCOHOL 70 mL/100mL N 20181231 66715-5301_559c7bf9-920a-4117-8a67-a971c3d822e7 66715-5301 HUMAN OTC DRUG Goodys Cool Orange Acetaminophen, Aspirin, and Caffeine POWDER ORAL 20140301 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 325; 500; 65 mg/1; mg/1; mg/1 E 20171231 66715-5631_0af3ce08-9753-4bf3-af47-97ba9cf29b18 66715-5631 HUMAN OTC DRUG Circle K Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part341 Lil Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 66715-5637_44dd1b82-8da3-4f0a-b45e-40f0cf4ae36c 66715-5637 HUMAN OTC DRUG Circle K Pain Reliever Acetaminophen TABLET ORAL 20141101 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN 500 mg/1 N 20191231 66715-5728_e21fd85c-06da-447d-a8f0-a47b0cbe51bf 66715-5728 HUMAN OTC DRUG Circle K Cold Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20191231 66715-5729_386831ff-07e5-4b4a-aead-c3f28d544e9d 66715-5729 HUMAN OTC DRUG Circle K Eye Drops Redness Reliever Tetrahydrozoline Hydrochloride SOLUTION/ DROPS TOPICAL 20160504 OTC MONOGRAPH FINAL part349 Lil Drug Store Products, Inc TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 66715-5730_7b5ec337-6d2a-4191-a7f7-7d299181cbb3 66715-5730 HUMAN OTC DRUG Circle K NoSnooze Caffeine TABLET ORAL 20141101 OTC MONOGRAPH FINAL part340 Lil' Drug Store Products, Inc CAFFEINE 200 mg/1 N 20191231 66715-5731_0af3ce08-9753-4bf3-af47-97ba9cf29b18 66715-5731 HUMAN OTC DRUG Circle K Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part341 Lil Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 66715-5734_67dfa914-a9e3-4195-ac6d-665f97f2f219 66715-5734 HUMAN OTC DRUG Circle K Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20141120 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20191231 66715-5737_44dd1b82-8da3-4f0a-b45e-40f0cf4ae36c 66715-5737 HUMAN OTC DRUG Circle K Pain Reliever Acetaminophen TABLET ORAL 20141101 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN 500 mg/1 N 20191231 66715-5738_b9eeccee-a2f5-4299-822d-4fdbc078a8ce 66715-5738 HUMAN OTC DRUG Circle K Headache Relief Acetaminophen, Aspirin, and Caffeine TABLET ORAL 20141101 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20191231 66715-5739_e5a7e517-1797-441e-9d3b-09f1ba4ad812 66715-5739 HUMAN OTC DRUG Circle K Ibuprofen Ibuprofen TABLET, COATED ORAL 20141101 ANDA ANDA075010 Lil' Drug Store Products, Inc IBUPROFEN 200 mg/1 N 20191231 66715-5744_8bf3b747-1fed-4f23-852c-f16de8381452 66715-5744 HUMAN OTC DRUG Circle K Multi-Symptom Sinus Relief Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20110601 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20191231 66715-5754_65694734-cb7f-4404-8f11-6fc6d5880dd4 66715-5754 HUMAN OTC DRUG Circle K Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 66715-5755_a91a1e62-f72f-450e-b8e9-3d271be6bab9 66715-5755 HUMAN OTC DRUG Circle K Stomach Bismuth Subsalicylate LIQUID ORAL 20151016 OTC MONOGRAPH FINAL part335 Lil' Drug Store Products, Inc BISMUTH SUBSALICYLATE 525 mg/30mL N 20191231 66715-5759_a5851ed2-545e-4545-9d8f-aa65f3959f19 66715-5759 HUMAN OTC DRUG Circle K Anti-Diarrheal Loperamide Hydrochloride TABLET ORAL 20141101 ANDA ANDA074091 Lil' Drug Store Products, Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20191231 66715-5760_8bc09489-7bf2-4fb2-9a50-7772e8117c9e 66715-5760 HUMAN OTC DRUG Circle K Congestion Relief Oxymetazoline Hydrochloride SPRAY NASAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20191231 66715-5761_f831b3e6-a2ba-4f86-be34-79768c07c8e9 66715-5761 HUMAN OTC DRUG Hand Sanitizer Circle K Alcohol GEL TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part333E Lil' Drug Store Products, Inc ALCOHOL 70 mL/100mL N 20191231 66715-5762_d25c2730-ece4-4b79-82f0-6d98ec84d00f 66715-5762 HUMAN OTC DRUG Antibacterial Hand Wipes Circle K Benzalkonium chloride CLOTH TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part333A Lil' Drug Store Products, Inc BENZALKONIUM CHLORIDE 1.3 mg/1 N 20191231 66715-5763_19b525ab-e37c-41f0-b4fb-83b73554d55c 66715-5763 HUMAN OTC DRUG Hand Sanitizer Lil Drug Store Products, Inc. Alcohol GEL TOPICAL 20151118 20200810 OTC MONOGRAPH NOT FINAL part333E Lil' Drug Store Products, Inc ALCOHOL .62 mL/mL N 20181231 66715-5765_67dfa914-a9e3-4195-ac6d-665f97f2f219 66715-5765 HUMAN OTC DRUG Circle K Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20141120 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20191231 66715-5766_67dfa914-a9e3-4195-ac6d-665f97f2f219 66715-5766 HUMAN OTC DRUG Circle K Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20141120 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20191231 66715-5767_67dfa914-a9e3-4195-ac6d-665f97f2f219 66715-5767 HUMAN OTC DRUG Circle K Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20141120 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20191231 66715-5768_0af3ce08-9753-4bf3-af47-97ba9cf29b18 66715-5768 HUMAN OTC DRUG Circle K Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part341 Lil Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 66715-5769_0af3ce08-9753-4bf3-af47-97ba9cf29b18 66715-5769 HUMAN OTC DRUG Circle K Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part341 Lil Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 66715-5807_cddfc862-c1c9-42ce-ade4-ed2653d5e75b 66715-5807 HUMAN OTC DRUG Circle K Ibuprofen Ibuprofen TABLET, COATED ORAL 20150110 ANDA ANDA076460 Lil Drug Store Products, Inc IBUPROFEN 200 mg/1 N 20181231 66715-5834_e0f98df6-6a23-4307-84b8-817a72fc32b3 66715-5834 HUMAN OTC DRUG Circle K Nighttime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate LIQUID ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20191231 66715-5839_c69a2fef-44db-4c57-a591-384262576d3b 66715-5839 HUMAN OTC DRUG Circle K Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20160621 ANDA ANDA075010 Lil Drug Store Products, Inc IBUPROFEN 200 mg/1 N 20181231 66715-5854_65694734-cb7f-4404-8f11-6fc6d5880dd4 66715-5854 HUMAN OTC DRUG Circle K Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 66715-5954_65694734-cb7f-4404-8f11-6fc6d5880dd4 66715-5954 HUMAN OTC DRUG Circle K Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20141101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 66715-6654_d53f706f-6fac-46ef-a514-d371055d6141 66715-6654 HUMAN OTC DRUG Lil Drug Store Products Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20150110 OTC MONOGRAPH FINAL part341 Lil Drug Store Products, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 66715-6703_e55263c4-81e1-4eab-8504-91ae092c3f5e 66715-6703 HUMAN OTC DRUG Circle K Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20171010 OTC MONOGRAPH FINAL part338 Lil Drug Store Products, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 66715-6704_92ecb69b-cdf1-44c7-891a-dff41bce77d6 66715-6704 HUMAN OTC DRUG Circle K Aspirin 325 Aspirin TABLET ORAL 20171010 OTC MONOGRAPH NOT FINAL part343 Lil Drug Store Products, Inc ASPIRIN 325 mg/1 N 20181231 66715-6705_b8d233cd-434f-4d26-9fb9-9af6dbdb8585 66715-6705 HUMAN OTC DRUG Circle K Triple Antibiotic Bacitracin zinc, Polymyxin B sulfate, and Neomycin sulfate OINTMENT TOPICAL 20171010 OTC MONOGRAPH FINAL part333B Lil Drug Store Products, Inc BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE 400; 5000; 3.5 [iU]/g; [iU]/g; mg/g N 20181231 66715-6706_ea3f1044-791b-4cec-a9a8-e9b71ec5612a 66715-6706 HUMAN OTC DRUG Circle K Headache Relief Extra Strength Acetaminophen, Aspirin, and Caffeine TABLET ORAL 20171010 OTC MONOGRAPH NOT FINAL part343 Lil Drug Store Products, Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 66715-6707_ef396beb-1994-4411-84cf-d6e8bf1d6456 66715-6707 HUMAN OTC DRUG Circle K Ibuprofen Ibuprofen TABLET, COATED ORAL 20150110 ANDA ANDA079174 Lil Drug Store Products, Inc IBUPROFEN 200 mg/1 N 20181231 66715-6708_722a0164-536a-4deb-b74c-5e00e46deb7d 66715-6708 HUMAN OTC DRUG Circle K Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20141101 OTC MONOGRAPH NOT FINAL part343 Lil Drug Store Products, Inc ACETAMINOPHEN 500 mg/1 N 20181231 66715-6754_d53f706f-6fac-46ef-a514-d371055d6141 66715-6754 HUMAN OTC DRUG Lil Drug Store Products Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20150110 OTC MONOGRAPH FINAL part341 Lil Drug Store Products, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 66715-6820_9acb43c3-e727-4d5e-befd-4172ebcd2325 66715-6820 HUMAN OTC DRUG Lil Drug Store Ibuprofen Ibuprofen TABLET, COATED ORAL 20170223 ANDA ANDA076460 Lil Drug Store Products, Inc IBUPROFEN 200 mg/1 N 20181231 66715-6821_2de7316f-7e61-4fdd-8b26-3880ece20eb1 66715-6821 HUMAN OTC DRUG Lil Drug Store Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20170117 OTC MONOGRAPH NOT FINAL part343 Lil Drug Store Products, Inc ACETAMINOPHEN 500 mg/1 N 20181231 66715-6831_5d5defa0-5ea7-436e-ad4e-5c0ebf48a8fe 66715-6831 HUMAN OTC DRUG Cold and Flu Daytime Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 66715-6832_9fac7c36-bd81-4759-b5ee-f6852f99891c 66715-6832 HUMAN OTC DRUG Lil Drug Store Eye Drops Redness Reliever Tetrahydrozoline Hydrochloride LIQUID TOPICAL 20160504 OTC MONOGRAPH FINAL part349 Lil Drug Store Products, Inc TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 66715-6834_32d85c14-6e1e-4220-8754-47568823112a 66715-6834 HUMAN OTC DRUG Cold and Flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20191231 66715-6835_fbd9c8d7-c447-4d6c-b6aa-440a46a00942 66715-6835 HUMAN OTC DRUG Lil Drug Store Petroleum Jelly Petrolatum JELLY TOPICAL 20160504 OTC MONOGRAPH FINAL part347 Lil Drug Store Products, Inc PETROLATUM 1 g/g N 20181231 66715-6839_4e56ed75-15b0-4595-8089-71cdb686e8d4 66715-6839 HUMAN OTC DRUG Lil Drug Store Ibuprofen Ibuprofen TABLET ORAL 20150110 ANDA ANDA079174 Lil Drug Store Products, Inc IBUPROFEN 200 mg/1 N 20191231 66715-6840_01ad21d6-f095-4119-9820-530cd111a666 66715-6840 HUMAN OTC DRUG Lil Drug Store Aspirin 325 Aspirin TABLET ORAL 20160504 OTC MONOGRAPH NOT FINAL part343 Lil Drug Store Products, Inc ASPIRIN 325 mg/1 N 20181231 66715-6843_d6fdbb4e-1c1a-48c3-ad8c-631607345246 66715-6843 HUMAN OTC DRUG Nighttime Sleep-Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part338 Lil' Drug Store Products, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 66715-6844_5e4eb2be-3149-4fdc-affb-7e2bb81fc2be 66715-6844 HUMAN OTC DRUG Lil Drug Store Multi-Symptom Sinus Severe Congestion Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20141215 OTC MONOGRAPH FINAL part341 Lil Drug Store Products, Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20191231 66715-6845_37a07482-ef67-4d6e-825a-9804429ee24b 66715-6845 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Lil Drug Store Products Isopropyl alcohol LIQUID TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part333A Lil' Drug Store Products, Inc ISOPROPYL ALCOHOL 500 mg/mL N 20191231 66715-6846_138ef5c3-d295-40e3-8873-eedc4f3af105 66715-6846 HUMAN OTC DRUG Hydrogen Peroxide Lil Drug Store Products Hydrogen Peroxide LIQUID TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part333A Lil' Drug Store Products, Inc HYDROGEN PEROXIDE 3 mL/100mL N 20191231 66715-6850_07b7096d-a531-4a1a-a003-cc535fccfc6f 66715-6850 HUMAN OTC DRUG 24 Hour Allergy Lil Drug Store Products Cetirizine hydrochloride TABLET ORAL 20141101 ANDA ANDA078780 Lil' Drug Store Products, Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20191231 66715-6851_5d5defa0-5ea7-436e-ad4e-5c0ebf48a8fe 66715-6851 HUMAN OTC DRUG Cold and Flu Daytime Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 66715-6852_5d5defa0-5ea7-436e-ad4e-5c0ebf48a8fe 66715-6852 HUMAN OTC DRUG Cold and Flu Daytime Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 66715-6853_5d5defa0-5ea7-436e-ad4e-5c0ebf48a8fe 66715-6853 HUMAN OTC DRUG Cold and Flu Daytime Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20140905 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 66715-6854_d53f706f-6fac-46ef-a514-d371055d6141 66715-6854 HUMAN OTC DRUG Lil Drug Store Products Allergy Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20150110 OTC MONOGRAPH FINAL part341 Lil Drug Store Products, Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 66715-6855_881e2abb-8af8-4711-979d-4e85510ec872 66715-6855 HUMAN OTC DRUG Stomach Lil Drug Store Products Bismuth Subsalicylate LIQUID ORAL 20141201 OTC MONOGRAPH FINAL part335 Lil' Drug Store Products, Inc BISMUTH SUBSALICYLATE 525 mg/30mL N 20191231 66715-6856_66578fe5-6ae2-4ec1-b940-1063c1f05b2e 66715-6856 HUMAN OTC DRUG Childrens Pain and Fever Lil Drug Store Products Acetaminophen LIQUID ORAL 20141201 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN 160 mg/5mL N 20191231 66715-6857_f886c5d6-d4eb-486e-84ee-c5147b70dd55 66715-6857 HUMAN OTC DRUG Lil Drug Store Infants Pain Reliever Acetaminophen LIQUID ORAL 20171017 OTC MONOGRAPH NOT FINAL part343 Lil Drug Store Products, Inc ACETAMINOPHEN 160 mg/5mL N 20181231 66715-6858_e687259e-b7e4-498a-b2d0-c3683a6cc752 66715-6858 HUMAN OTC DRUG Adult Tussin DM Lil Drug Store Products Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 20141201 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20191231 66715-6859_aa9e0196-7f91-4b68-b5f0-0afb33bc6865 66715-6859 HUMAN OTC DRUG Lil Drug Store Anti-Diarrheal Soft Gelatin Loperamide Hydrochloride CAPSULE, LIQUID FILLED ORAL 20150201 NDA NDA021855 Lil' Drug Store Products, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 66715-6860_3d2bc2ec-2383-436a-ab64-bc42c6022281 66715-6860 HUMAN OTC DRUG Congestion Relief Lil Drug Store Products Oxymetazoline Hydrochloride SPRAY NASAL 20141201 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20191231 66715-6861_7f092f11-2c30-49b9-ae7c-300cc0f547b6 66715-6861 HUMAN OTC DRUG Antiseptic Lil Drug Store Products Eucalyptol, Menthol, Unspecified Form, Methyl salicylate, and Thymol LIQUID ORAL 20141201 OTC MONOGRAPH NOT FINAL part356 Lil' Drug Store Products, Inc EUCALYPTOL; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 66715-6920_5a0f5242-9cf3-4f22-a7ea-0b937580335c 66715-6920 HUMAN OTC DRUG Lil Drug Store Ibuprofen Ibuprofen TABLET, COATED ORAL 20170223 ANDA ANDA076460 Lil Drug Store Products, Inc IBUPROFEN 200 mg/1 N 20181231 66715-6931_ac7c58d6-3135-467b-99a3-03605af0e091 66715-6931 HUMAN OTC DRUG Daytime Cold and Flu Lil Drug Store Products Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride LIQUID ORAL 20141201 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20191231 66715-6934_8eed1cdd-9b78-468a-92e5-f112fc7543fa 66715-6934 HUMAN OTC DRUG Nighttime Cold and Flu Lil Drug Store Products Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate LIQUID ORAL 20141201 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20191231 66715-7012_6d225859-109d-4c62-8482-d6f602aa5018 66715-7012 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part333E Lil' Drug Store Products, Inc ALCOHOL .62 mL/mL N 20191231 66715-9700_b16ff470-ddab-47ca-942a-e84eec19cee1 66715-9700 HUMAN OTC DRUG Advil Ibuprofen TABLET, COATED ORAL 20100222 NDA NDA018989 Lil' Drug Store Products, Inc. IBUPROFEN 200 mg/1 N 20181231 66715-9702_7af0475d-33d5-4c13-ad06-5bb66465eb94 66715-9702 HUMAN OTC DRUG Aleve Naproxen Sodium TABLET ORAL 20000101 NDA NDA020204 Lil' Drug Store Products, Inc NAPROXEN SODIUM 220 mg/1 E 20171231 66715-9703_dc64ddc0-3a44-4a08-8bce-8ab5863dda8b 66715-9703 HUMAN OTC DRUG Alka-Seltzer Anhydrous Citric Acid, Aspirin, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20000101 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 325; 1916 mg/1; mg/1; mg/1 E 20171231 66715-9704_e7362d03-d1e0-4de8-ad7a-f6dcbbe2291b 66715-9704 HUMAN OTC DRUG DayQuil Severe Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20130621 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 66715-9705_11660179-d0ad-4eb2-b8d7-63d7cabe5e46 66715-9705 HUMAN OTC DRUG Lil Drug Store NyQuil Severe Cold and Flu, Max Strength Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, and Dextromethorphan Hydrobromide TABLET, COATED ORAL 20160407 OTC MONOGRAPH FINAL part341 Lil Drug Store Products, Inc ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE 325; 5; 6.25; 10 mg/1; mg/1; mg/1; mg/1 N 20181231 66715-9706_35d48fbc-2417-42c0-8401-64ba25182560 66715-9706 HUMAN OTC DRUG Benadryl Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20100916 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 66715-9707_fea699e4-6a51-4ba5-8f70-d78defbcab46 66715-9707 HUMAN OTC DRUG Allegra Allergy Fexofenadine Hydrochloride TABLET ORAL 20140901 NDA NDA020872 Lil' Drug Store Products, Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20191231 66715-9709_23eb7c64-9642-4cc0-bcfd-90483722143b 66715-9709 HUMAN OTC DRUG Dramamine Dimenhydrinate TABLET, CHEWABLE ORAL 20100510 OTC MONOGRAPH FINAL part336 Lil' Drug Store Products, Inc. DIMENHYDRINATE 50 mg/1 N 20191231 66715-9712_991872d6-18a5-4edb-9547-dadeb440da2c 66715-9712 HUMAN OTC DRUG Motrin IB Ibuprofen TABLET, COATED ORAL 20100510 NDA NDA019012 Lil' Drug Store Products, Inc. IBUPROFEN 200 mg/1 N 20191231 66715-9713_1843dbea-0c03-4ccc-8af3-c3658ac607eb 66715-9713 HUMAN OTC DRUG NyQuil Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20100916 20181215 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 66715-9720_7ab79c95-c139-439e-bb51-aee7f84766f3 66715-9720 HUMAN OTC DRUG Imodium AD Loperamide Hydrochloride TABLET, COATED ORAL 20100510 20200919 NDA NDA019860 Lil' Drug Store Products, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 66715-9723_045455cf-fd71-409a-be8b-60b2796f057c 66715-9723 HUMAN OTC DRUG Pepto-Bismol Bismuth subsalicylate TABLET, CHEWABLE ORAL 20100916 OTC MONOGRAPH FINAL part335 Lil' Drug Store Products, Inc. BISMUTH SUBSALICYLATE 262 mg/1 N 20191231 66715-9724_9f92bccc-0b87-4d8f-b3c2-17412fca10ed 66715-9724 HUMAN OTC DRUG Mucinex DM Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20100510 NDA NDA021620 Lil' Drug Store Products, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 600; 30 mg/1; mg/1 N 20181231 66715-9726_ba250132-6df0-4dc6-ada4-7de82a1d55da 66715-9726 HUMAN OTC DRUG BAYER ASPIRIN TABLET ORAL 20090701 OTC MONOGRAPH FINAL part343 Lil' Drug Store Products, Inc. ASPIRIN 325 mg/1 E 20171231 66715-9727_e767d1e9-35eb-45b6-9585-febdbc74e1a6 66715-9727 HUMAN OTC DRUG Lil Drug Store Allergy Sinus Relief Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride TABLET ORAL 20110208 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 66715-9728_e5c08198-bf69-47eb-9952-e1bff8615c5b 66715-9728 HUMAN OTC DRUG Lil Drug Store Cold Relief Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20110203 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 66715-9730_7564789d-50d9-490e-b9fd-0d5c6ce49580 66715-9730 HUMAN OTC DRUG Lil Drug Store NoSnooze Caffeine TABLET ORAL 20110208 OTC MONOGRAPH FINAL part340 Lil' Drug Store Products, Inc. CAFFEINE 200 mg/1 N 20191231 66715-9732_b6df9c9d-5fa0-4a6b-8f5e-79743ccdfb64 66715-9732 HUMAN OTC DRUG Lil Drug Store Claritin Non-Drowsy, 24 Hour Loratadine TABLET ORAL 20110421 NDA NDA019658 Lil' Drug Store Products, Inc LORATADINE 10 mg/1 N 20181231 66715-9733_9b77f7cb-eb22-455b-bdc0-6c1bc3e05f20 66715-9733 HUMAN OTC DRUG Advil PM Ibuprofen and Diphenhydramine citrate TABLET, COATED ORAL 20100511 NDA NDA021394 Lil' Drug Store Products, Inc. IBUPROFEN; DIPHENHYDRAMINE CITRATE 200; 38 mg/1; mg/1 N 20181231 66715-9735_2cdd4508-98cd-4854-a421-3d1dac80b9ac 66715-9735 HUMAN OTC DRUG Alka-Seltzer Plus Aspirin, Chlorpheniramine Maleate, and Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20000101 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 E 20171231 66715-9736_43f89dac-6ef6-40b0-a7c3-ed2d8e147331 66715-9736 HUMAN OTC DRUG Zantac 150 Acid Reducer Ranitidine TABLET ORAL 20101101 NDA NDA021698 Lil' Drug Store Products, Inc RANITIDINE HYDROCHLORIDE 150 mg/1 N 20191231 66715-9737_31a019cd-3ae5-4796-93ce-90948c181d74 66715-9737 HUMAN OTC DRUG Lil Drug Store Pain Reliever Extra Strength Acetaminophen TABLET ORAL 20110127 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 66715-9738_23df7a98-f3f0-4d19-be7f-c6f1063e8531 66715-9738 HUMAN OTC DRUG Lil Drug Store Headache Relief Extra Strength Acetaminophen, Aspirin, and Caffeine TABLET ORAL 20110127 ANDA ANDA075794 Lil' Drug Store Products, Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 66715-9739_bcd87a40-776b-425a-ae89-4c45eafde8cf 66715-9739 HUMAN OTC DRUG Lil Drug Store Ibuprofen Ibuprofen TABLET ORAL 20110127 ANDA ANDA075010 Lil' Drug Store Products, Inc. IBUPROFEN 200 mg/1 N 20181231 66715-9740_57fc2e5c-24d0-4e57-89df-bcecb2689fe5 66715-9740 HUMAN OTC DRUG Lil Drug Store Pain Relief All Day Naproxen Sodium TABLET ORAL 20110127 ANDA ANDA079096 Lil' Drug Store Products, Inc. NAPROXEN SODIUM 220 mg/1 N 20191231 66715-9744_798c0d6b-cc52-42f8-8a60-2674b100feda 66715-9744 HUMAN OTC DRUG Lil Drug Store Multi-Symptom Sinus Relief Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20110601 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 66715-9745_dacfeb85-6a11-4c00-9cba-c8f70a98dbd5 66715-9745 HUMAN OTC DRUG Midol Complete Acetaminophen, Caffeine, and Pyrilamine Maleate TABLET ORAL 20111201 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 66715-9746_1689ea6f-eb5b-4fc9-a801-7c306013538a 66715-9746 HUMAN OTC DRUG ZzzQuil Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20151223 OTC MONOGRAPH FINAL part338 Lil' Drug Store Products, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/21 E 20171231 66715-9747_9aca213a-6bc5-4353-9bc2-a7a837629f96 66715-9747 HUMAN OTC DRUG TYLENOL EXTRA STRENGTH Acetaminophen TABLET, COATED ORAL 20110809 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc. ACETAMINOPHEN 500 mg/1 N 20191231 66715-9756_9a43eb04-8ff2-4b28-a258-a4ae5d270812 66715-9756 HUMAN OTC DRUG Lil Drug Store Tylenol Cold plus Flu Severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20171023 OTC MONOGRAPH FINAL part341 Lil Drug Store Products, Inc ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20191231 66715-9757_94a7ac33-bd9a-47c1-b862-248ad0a96fa9 66715-9757 HUMAN OTC DRUG Lil Drug Store Tylenol Sinus Severe Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET, COATED ORAL 20171023 OTC MONOGRAPH FINAL part341 Lil Drug Store Products, Inc ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20191231 66715-9799_ee3b84f6-9173-473a-8735-5ad991e7eed3 66715-9799 HUMAN OTC DRUG NoDoz Alertness Aid Maximum Strength Caffeine TABLET, FILM COATED ORAL 20171207 OTC MONOGRAPH FINAL part340 Lil' Drug Store Products, Inc. CAFFEINE 200 mg/1 N 20191231 66715-9810_b7210895-8355-4794-8a8a-7c363fd3284a 66715-9810 HUMAN OTC DRUG Excedrin Extra Strength Acetaminophen, Aspirin, and Caffeine TABLET, FILM COATED ORAL 20100510 OTC MONOGRAPH NOT FINAL part343 Lil Drug Store Products, Inc ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20191231 66715-9815_1ab56648-1186-4d1b-98d7-9462b489d3da 66715-9815 HUMAN OTC DRUG BC Cherry Aspirin and Caffeine POWDER ORAL 20140301 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc ASPIRIN; CAFFEINE 845; 65 mg/1; mg/1 E 20171231 66715-9817_d9c8c663-9acf-400b-be6d-ef8b3d3b04bd 66715-9817 HUMAN OTC DRUG Lil Drug Store Tylenol PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20171020 OTC MONOGRAPH NOT FINAL part343 Lil' Drug Store Products, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20191231 66715-9827_e767d1e9-35eb-45b6-9585-febdbc74e1a6 66715-9827 HUMAN OTC DRUG Lil Drug Store Allergy Sinus Relief Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride TABLET ORAL 20110208 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 66715-9828_e5c08198-bf69-47eb-9952-e1bff8615c5b 66715-9828 HUMAN OTC DRUG Lil Drug Store Cold Relief Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20110203 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 66715-9830_7564789d-50d9-490e-b9fd-0d5c6ce49580 66715-9830 HUMAN OTC DRUG Lil Drug Store NoSnooze Caffeine TABLET ORAL 20110208 OTC MONOGRAPH FINAL part340 Lil' Drug Store Products, Inc. CAFFEINE 200 mg/1 N 20191231 66715-9844_798c0d6b-cc52-42f8-8a60-2674b100feda 66715-9844 HUMAN OTC DRUG Lil Drug Store Multi-Symptom Sinus Relief Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20110601 OTC MONOGRAPH FINAL part341 Lil' Drug Store Products, Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 66733-948_2d88fca3-0606-4e25-a81d-9bd7c9d77908 66733-948 HUMAN PRESCRIPTION DRUG ERBITUX cetuximab SOLUTION INTRAVENOUS 20040212 BLA BLA125084 ImClone LLC CETUXIMAB 2 mg/mL Epidermal Growth Factor Receptor Antagonist [EPC],HER1 Antagonists [MoA] N 20181231 66733-958_2d88fca3-0606-4e25-a81d-9bd7c9d77908 66733-958 HUMAN PRESCRIPTION DRUG ERBITUX cetuximab SOLUTION INTRAVENOUS 20071002 BLA BLA125084 ImClone LLC CETUXIMAB 2 mg/mL Epidermal Growth Factor Receptor Antagonist [EPC],HER1 Antagonists [MoA] N 20181231 66738-701_f25515ab-1252-4aec-87e3-3f83f17fbda4 66738-701 HUMAN OTC DRUG Pit Boss Antiperspirant and Deodorant Antiperspirant/Deodorant STICK TOPICAL 20121206 OTC MONOGRAPH FINAL part350 Jack Black L.L.C. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 25 g/100g E 20171231 66754-001_ba93b58b-5da4-482a-8ee5-053c2c9380bf 66754-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19800101 NDA NDA205712 Eureka Oxygen Company OXYGEN 990 mL/L N 20181231 66758-035_0a54ccdf-79ce-420e-945c-a2fb8f56141c 66758-035 HUMAN PRESCRIPTION DRUG Granisetron Granisetron INJECTION INTRAVENOUS 20080630 ANDA ANDA078835 Sandoz Inc GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 66758-036_0a54ccdf-79ce-420e-945c-a2fb8f56141c 66758-036 HUMAN PRESCRIPTION DRUG Granisetron Granisetron INJECTION INTRAVENOUS 20080630 ANDA ANDA078835 Sandoz Inc GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 66758-040_b4c82062-08eb-482e-ba9d-6423ad032a98 66758-040 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20090601 ANDA ANDA090039 Sandoz Inc METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 66758-041_b4c82062-08eb-482e-ba9d-6423ad032a98 66758-041 HUMAN PRESCRIPTION DRUG Methotrexate Sodium Methotrexate Sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20090601 ANDA ANDA090029 Sandoz Inc METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 66758-042_516afd6b-38ec-4819-9bb1-37606c0d6739 66758-042 HUMAN PRESCRIPTION DRUG Epirubicin Hydrochloride Epirubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20091222 ANDA ANDA065339 Sandoz Inc EPIRUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] E 20171231 66758-043_b590e67e-85d6-475b-a622-8f99a7c7bfca 66758-043 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION, SOLUTION INTRAVENOUS 20080102 ANDA ANDA078167 Sandoz Inc PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 66758-044_19dd287f-9d5d-4742-913f-25afa34bf277 66758-044 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20080910 ANDA ANDA040772 Sandoz Inc FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 66758-046_ff9d0403-be44-469d-9dfe-d2156094bf60 66758-046 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION, SOLUTION INTRAVENOUS 20071012 NDA NDA022137 Sandoz Inc FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 66758-047_4ab1835d-95a1-4864-9739-d26fee1e4d8b 66758-047 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20100131 ANDA ANDA078280 Sandoz Inc CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 66758-048_4abb4315-bcd7-4055-aea4-2496bbb871f1 66758-048 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20091130 ANDA ANDA090137 Sandoz Inc IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 66758-050_8013c462-2679-43e9-8227-f9a52db0450a 66758-050 HUMAN PRESCRIPTION DRUG Docetaxel docetaxel INJECTION, SOLUTION INTRAVENOUS 20110629 NDA NDA201525 Sandoz Inc DOCETAXEL 10 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 66758-051_6bc88223-4de9-4ff7-b59f-e479c1fce600 66758-051 HUMAN PRESCRIPTION DRUG Topotecan Topotecan INJECTION INTRAVENOUS 20110225 NDA NDA200199 Sandoz Inc TOPOTECAN HYDROCHLORIDE 1 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] E 20171231 66758-054_1b835751-d6a4-49b6-b0f8-23ab31b0d04e 66758-054 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20110502 ANDA ANDA091299 Sandoz Inc FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 66758-055_615d206a-b178-4ff4-b6c1-7e349099f3c7 66758-055 HUMAN PRESCRIPTION DRUG Idarubicin Hydrochloride Idarubicin Hydrochloride INJECTION INTRAVENOUS 20110329 ANDA ANDA091293 Sandoz Inc IDARUBICIN HYDROCHLORIDE 1 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] E 20171231 66758-110_91115262-b323-4107-b7ff-8a2d746bd98a 66758-110 HUMAN PRESCRIPTION DRUG KLOR-CON potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140901 NDA NDA019123 Sandoz Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 66758-140_bf7893d6-6ead-4c63-b71d-2862fa8a6d52 66758-140 HUMAN PRESCRIPTION DRUG KLOR-CON/EF Potassium Bicarbonate TABLET, EFFERVESCENT ORAL 20140901 UNAPPROVED DRUG OTHER Sandoz Inc. POTASSIUM BICARBONATE 978 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 66758-160_91115262-b323-4107-b7ff-8a2d746bd98a 66758-160 HUMAN PRESCRIPTION DRUG KLOR-CON potassium chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140901 NDA NDA019123 Sandoz Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 66758-170_32ca7bfa-d049-4401-a871-05855eb86e81 66758-170 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Sandoz Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 66758-180_32ca7bfa-d049-4401-a871-05855eb86e81 66758-180 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Sandoz Inc. POTASSIUM CHLORIDE 1125 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 66758-190_32ca7bfa-d049-4401-a871-05855eb86e81 66758-190 HUMAN PRESCRIPTION DRUG KLOR-CON M potassium chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Sandoz Inc. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 66758-202_707cd605-bc2c-4ad4-ae83-debec5597174 66758-202 HUMAN PRESCRIPTION DRUG Klor-Con Sprinkle Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20150710 ANDA ANDA203106 Sandoz POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 66758-205_707cd605-bc2c-4ad4-ae83-debec5597174 66758-205 HUMAN PRESCRIPTION DRUG Klor-Con Sprinkle Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20150710 ANDA ANDA203106 Sandoz POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 66758-208_7feaf7c2-2c08-4b0d-bedf-bdec7507b390 66758-208 HUMAN PRESCRIPTION DRUG Transderm Scop scopolamine PATCH, EXTENDED RELEASE TRANSDERMAL 20161201 NDA NDA017874 Sandoz Inc SCOPOLAMINE 1 mg/3d Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 66758-950_bee46ef8-861a-4872-a186-d814d01a37f2 66758-950 HUMAN PRESCRIPTION DRUG Docetaxel docetaxel INJECTION, SOLUTION INTRAVENOUS 20150722 NDA NDA201525 Sandoz Inc DOCETAXEL 10 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 66761-122_3510ecfb-ef70-4043-be0c-cccb00af8727 66761-122 HUMAN OTC DRUG Tiger Balm Muscle Rub Pain Relieving Methyl Salicylate, Menthol, and Camphor (Synthetic) CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC) 150; 50; 30 mg/g; mg/g; mg/g N 20191231 66761-308_908ef81d-ab06-4115-816a-c819aca97918 66761-308 HUMAN OTC DRUG Tiger Balm Red Extra Strength Camphor (Synthetic) and Menthol OINTMENT TOPICAL 20050817 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); MENTHOL 110; 100 mg/g; mg/g N 20191231 66761-309_03084075-e885-4789-a9a7-4145e7a6ee6d 66761-309 HUMAN OTC DRUG Tiger Balm White Regular Strength Camphor (Synthetic) and Menthol OINTMENT TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); MENTHOL 110; 80 mg/g; mg/g N 20191231 66761-311_88e58199-2c7d-4fae-b8f7-3cd4125494ed 66761-311 HUMAN OTC DRUG Kwan Loong Methyl salicylate and Menthol OIL TOPICAL 20050901 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM 350; 160 mg/mL; mg/mL N 20191231 66761-315_197cb1a6-9380-4eda-aeb9-95c20130573f 66761-315 HUMAN OTC DRUG Tiger Balm Ultra Strength Camphor (Synthetic) and Menthol OINTMENT TOPICAL 20050817 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM 110; 110 mg/g; mg/g N 20191231 66761-321_e058d38b-55c7-49ca-878d-9471146c0749 66761-321 HUMAN OTC DRUG Tiger Balm Camphor (Synthetic) and Menthol PATCH TOPICAL 20070115 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); MENTHOL 230; 70 mg/1; mg/1 N 20191231 66761-322_0f2061a2-39f5-4f00-8be6-1219a4e13f44 66761-322 HUMAN OTC DRUG Tiger Balm Camphor (Synthetic), Menthol, and Capsicum PATCH TOPICAL 20011115 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; CAPSICUM 80; 24; 16 mg/1; mg/1; mg/1 N 20191231 66761-323_bea7ee1d-db1d-43ac-93ae-5bceebff8754 66761-323 HUMAN OTC DRUG TIGER BALM PAIN RELIEVING HYDROGEL Camphor (Synthetic), Levomenthol, and Capsicum PATCH TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; CAPSICUM 110; 33; 22 mg/1; mg/1; mg/1 N 20191231 66761-324_f8cfa8b1-e093-4cac-ab39-02f7030260b7 66761-324 HUMAN OTC DRUG Tiger Balm Pain Relieving Hydrogel Large CAMPHOR (SYNTHETIC), LEVOMENTHOL, and CAPSICUM PATCH TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); LEVOMENTHOL; CAPSICUM 230; 70; 46 mg/1; mg/1; mg/1 N 20191231 66761-333_98e106bb-2d6f-45c5-bd81-06b0ae14ef2a 66761-333 HUMAN OTC DRUG Tiger Balm Methyl Salicylate and Menthol LINIMENT TOPICAL 20051208 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM 260.4; 148.8 mg/mL; mg/mL N 20191231 66761-341_95b14dd1-0280-4548-adc8-951939e67d88 66761-341 HUMAN OTC DRUG Tiger Balm Neck and Shoulder Rub Camphor (Synthetic) and Menthol CREAM TOPICAL 20081024 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM 11; 10 mg/g; mg/g N 20191231 66761-710_bb0b4119-ddcf-4cb1-b97f-fdb3e0e90690 66761-710 HUMAN OTC DRUG Tiger Balm Ultra Thin Methyl Salicylate and Menthol PATCH TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part348 Haw Par Healthcare Ltd. METHYL SALICYLATE; MENTHOL 200; 60 mg/1; mg/1 N 20191231 66767-998_036b7d53-49ef-4c97-b75d-3f46f5745084 66767-998 HUMAN PRESCRIPTION DRUG Liquid Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20151203 NDA NDA205712 Metz Medical, Inc OXYGEN 99 L/100L E 20171231 66767-999_7c61f218-66e2-4fbd-9104-b12db26519ab 66767-999 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20151125 UNAPPROVED MEDICAL GAS Metz Medical, Inc OXYGEN 1 L/L E 20171231 66774-1001_06ab05e1-e358-4cfe-b092-e5eacf629918 66774-1001 HUMAN OTC DRUG Blister Blaster Benzalkonium chloride LIQUID TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part333A Quadex Pharmaceuticals, LLC BENZALKONIUM CHLORIDE .12 g/100mL N 20181231 66774-1003_4fc1e4bd-01d8-4675-9e2e-a4ff884bda11 66774-1003 HUMAN OTC DRUG Viroxyn Professional Use Benzalkonium chloride and Benzocaine LIQUID TOPICAL 20121022 OTC MONOGRAPH NOT FINAL part348 Quadex Pharmaceuticals LLC BENZALKONIUM CHLORIDE; BENZOCAINE 1.14; 65.775 mg/mL; mg/mL E 20171231 66794-011_10bc0d19-e056-4a2c-b053-e9ea3220aa0f 66794-011 HUMAN PRESCRIPTION DRUG Terrell Isoflurane LIQUID RESPIRATORY (INHALATION) 20100101 ANDA ANDA074416 Piramal Critical Care Inc ISOFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 66794-012_6155b026-d821-a1a3-e053-2991aa0a2bfe 66794-012 HUMAN PRESCRIPTION DRUG Sojourn Sevoflurane LIQUID RESPIRATORY (INHALATION) 20100413 ANDA ANDA077867 Piramal Critical Care Inc SEVOFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 66794-015_6156639c-0f3f-7165-e053-2991aa0aa1af 66794-015 HUMAN PRESCRIPTION DRUG Sevoflurane Sevoflurane LIQUID RESPIRATORY (INHALATION) 20110715 ANDA ANDA077867 Piramal Critical Care Inc SEVOFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 66794-017_60f0ffda-442e-19de-e053-2a91aa0a4dfd 66794-017 HUMAN PRESCRIPTION DRUG Isoflurane Isoflurane LIQUID RESPIRATORY (INHALATION) 20111007 ANDA ANDA074502 Piramal Critical Care Inc ISOFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 66794-019_60f2318c-f974-19ff-e053-2a91aa0a84cf 66794-019 HUMAN PRESCRIPTION DRUG Terrell Isoflurane LIQUID RESPIRATORY (INHALATION) 20120321 ANDA ANDA074502 Piramal Critical Care Inc ISOFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 66794-020_9a958170-5305-4637-b390-855691349940 66794-020 HUMAN PRESCRIPTION DRUG Isoflurane Isoflurane LIQUID RESPIRATORY (INHALATION) 20131113 ANDA ANDA074416 Piramal Critical Care Inc ISOFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 66794-021_228455fe-c1bf-46ce-8bb9-31d9969c78e8 66794-021 HUMAN PRESCRIPTION DRUG Desflurane Desflurane LIQUID RESPIRATORY (INHALATION) 20170101 ANDA ANDA090363 Piramal Critical Care Inc DESFLURANE 1 mL/mL General Anesthesia [PE],General Anesthetic [EPC] E 20171231 66794-151_63af2eb8-696f-907b-e053-2991aa0a7c08 66794-151 HUMAN PRESCRIPTION DRUG Gablofen Baclofen Injection INJECTION, SOLUTION INTRATHECAL 20170401 NDA NDA022462 Piramal Critical Care Inc BACLOFEN 50 ug/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20191231 66794-155_63af2eb8-696f-907b-e053-2991aa0a7c08 66794-155 HUMAN PRESCRIPTION DRUG Gablofen Baclofen Injection INJECTION, SOLUTION INTRATHECAL 20170401 NDA NDA022462 Piramal Critical Care Inc BACLOFEN 500 ug/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20191231 66794-156_63af2eb8-696f-907b-e053-2991aa0a7c08 66794-156 HUMAN PRESCRIPTION DRUG Gablofen Baclofen Injection INJECTION, SOLUTION INTRATHECAL 20170401 NDA NDA022462 Piramal Critical Care Inc BACLOFEN 1000 ug/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20191231 66794-157_63af2eb8-696f-907b-e053-2991aa0a7c08 66794-157 HUMAN PRESCRIPTION DRUG Gablofen Baclofen Injection INJECTION, SOLUTION INTRATHECAL 20170401 NDA NDA022462 Piramal Critical Care Inc BACLOFEN 2000 ug/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20191231 66803-001_e981f8e3-5c82-4160-9c00-c1242346d63c 66803-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Georgia Oxygen & Home Health OXYGEN 99 L/100L E 20171231 66828-0030_d56c24fb-196d-4775-b67f-13c5e41bd150 66828-0030 HUMAN PRESCRIPTION DRUG Gleevec imatinib mesylate TABLET ORAL 20010515 NDA NDA021588 Novartis Pharma Produktions GmbH IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] E 20171231 66831-123_b7144551-cebd-4345-b476-307289789f45 66831-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19860101 UNAPPROVED MEDICAL GAS Arroyo Medical Supply dba Zia Health Care OXYGEN 99 L/100L E 20171231 66846-010_60172cfa-287a-5adf-e053-2a91aa0afdfc 66846-010 HUMAN OTC DRUG CC CREME Soin Perfecteur de peau Skin Perfecting OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20170513 OTC MONOGRAPH NOT FINAL part352 Codif International OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 59.9; 20; 53.4 mg/mL; mg/mL; mg/mL N 20181231 66846-011_5cf0f572-48d8-6a3a-e053-2991aa0a8437 66846-011 HUMAN OTC DRUG CC CREME 02 Soin Perfecteur de peau Skin Perfecting OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20170513 OTC MONOGRAPH NOT FINAL part352 Codif International OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 59.9; 20; 53.4 mg/mL; mg/mL; mg/mL N 20181231 66854-001_d5e0b1f7-aecb-40d6-b2ea-41257b43cc5f 66854-001 HUMAN OTC DRUG Spai-Sons Calendula/Marigold Calendula Officinalis Flower Extract CREAM TOPICAL 20040601 OTC MONOGRAPH FINAL part358H SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS CALENDULA OFFICINALIS FLOWER; SULFUR 20; .11 g/100g; g/100g E 20171231 66854-002_4e7897cf-7e6f-4f68-bb1c-660f2ab94dd9 66854-002 HUMAN OTC DRUG FEIX BIOAZUFRE / BIOSULPHUR SULFUR SOAP TOPICAL 20060501 OTC MONOGRAPH NOT FINAL part358H SPAI-SONS PHAMACEUTICAL INTERNATIONAL COSMETICS SULFUR 2 g/100g E 20171231 66854-003_63764ca7-1280-4fec-a562-b73eb70644b3 66854-003 HUMAN OTC DRUG GYNOX-SOFT BORIC ACID EMULSION TOPICAL 20120630 UNAPPROVED DRUG OTHER SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS BORIC ACID 7 mg/100mL E 20171231 66854-004_232823a8-d199-498c-98b3-15e8ad88ee2f 66854-004 HUMAN PRESCRIPTION DRUG DERMAPROT TRICLOTREX-B TRICLOSAN LIQUID TOPICAL 20120830 OTC MONOGRAPH FINAL part333E SAPI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS TRICLOSAN .3 mg/100mL E 20171231 66854-006_2cab6659-fb21-4d52-98bc-366ddf39ee6a 66854-006 HUMAN OTC DRUG SPAI-SONS FLOOP C ALUMINUM CHLOROHYDRATE CREAM TOPICAL 20090901 OTC MONOGRAPH FINAL part350 SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS ALUMINUM CHLOROHYDRATE 28 g/100g E 20171231 66854-007_314f1ebc-353d-413e-beff-ddf3336e051a 66854-007 HUMAN PRESCRIPTION DRUG SPAI-SONS PROLAC-VIT BIOTIN LIQUID TOPICAL 20120806 UNAPPROVED DRUG OTHER SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS BIOTIN .01 mg/100mL E 20171231 66854-008_85a6c379-b149-49e9-a2a9-bf2c1758b033 66854-008 HUMAN OTC DRUG SPAI-SONS FLOOP R ALUMINUM CHLOROHYDRATE EMULSION TOPICAL 20071101 OTC MONOGRAPH FINAL part350 SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS ALUMINUM CHLOROHYDRATE 280 mL/1000mL E 20171231 66854-009_ad451d2e-292a-42db-8b48-0a98e11637da 66854-009 HUMAN OTC DRUG EOUX DEODORANT ALUMINUM CHLOROHYDRATE EMULSION TOPICAL 20120531 OTC MONOGRAPH FINAL part350 SPAI SONS PHARMACEUTICAL INTERNATIONAL COSMETICS ALUMINUM CHLOROHYDRATE 280 mL/1000mL E 20171231 66854-010_e6c652d5-fd27-4b09-aa3f-262fa3076532 66854-010 HUMAN OTC DRUG BIONA-VIT CONTROLS AND PREVENTS HAIR LOSS BIOTIN LIQUID TOPICAL 20120630 UNAPPROVED DRUG OTHER SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS BIOTIN .01 mL/100mL E 20171231 66854-011_79484ac9-ea4f-438a-af6f-b58bc8c5e118 66854-011 HUMAN OTC DRUG SPAI-SONS PROCAPELL BIOTIN LIQUID TOPICAL 20120630 UNAPPROVED DRUG OTHER SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS BIOTIN .01 mL/100mL E 20171231 66854-013_02b48851-bdcc-4a02-8168-35a65d768f73 66854-013 HUMAN OTC DRUG DERMAPROT TRICLOTREX-B TRICLOSAN LIQUID TOPICAL 20120531 OTC MONOGRAPH FINAL part333E SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS TRICLOSAN .3 mL/100mL E 20171231 66854-015_73093bfc-143f-4c62-a590-29cba99d0ff5 66854-015 HUMAN OTC DRUG TRICLOTREX-B ANTIBACTERIAL TRICLOSAN GEL TOPICAL 20120416 OTC MONOGRAPH FINAL part333E SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS TRICLOSAN .3 g/100g E 20171231 66854-016_7d5b0d07-c818-43eb-991e-9f8db5a36101 66854-016 HUMAN OTC DRUG TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) TRICLOSAN GEL TOPICAL 20120416 OTC MONOGRAPH FINAL part333E SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS TRICLOSAN .3 g/100g E 20171231 66854-017_0e71594b-a004-44cb-a8ae-f76ee1b1db4b 66854-017 HUMAN OTC DRUG SPAI-SONS ALKALINE DRY-DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20120630 OTC MONOGRAPH FINAL part358H SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS PYRITHIONE ZINC 1 mL/100mL E 20171231 66854-018_58da040b-6dcb-47d4-8617-b5eae34c1718 66854-018 HUMAN OTC DRUG SPAI-SONS FINE TALCUM TALC POWDER TOPICAL 20120630 OTC MONOGRAPH NOT FINAL part347 SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS TALC; ZINC OXIDE 81; 5 g/100g; g/100g E 20171231 66854-020_69fcc2d1-dcb1-4a73-8a3a-4f8e411620b2 66854-020 HUMAN OTC DRUG TK-NAX BIOTIN LIQUID TOPICAL 20120630 UNAPPROVED DRUG OTHER SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS BIOTIN .01 mL/100mL E 20171231 66854-021_e8a9a451-b8b7-4ed3-8ca9-26ac2aee1bd1 66854-021 HUMAN OTC DRUG SPAI-SONS ACID ANTI-DANDRUFF SULFUR SHAMPOO TOPICAL 20120630 OTC MONOGRAPH FINAL part358H SPAI-SONS PHARAMCUETICAL INTERNATIONAL COSMETICS SULFUR .4 mL/100mL E 20171231 66854-023_c18084e3-4a9d-4622-8d28-32fc10c29656 66854-023 HUMAN OTC DRUG SPAI-SONS MARIGOLD OILY SKIN SULFUR CREAM TOPICAL 20120630 OTC MONOGRAPH FINAL part358H SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS SULFUR .1 g/100g E 20171231 66854-024_08e18a05-4766-4a2a-9c3f-372a4a274853 66854-024 HUMAN OTC DRUG FEIX FACIAL SULFUR LIQUID TOPICAL 20120630 OTC MONOGRAPH FINAL part358H SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS SULFUR; DIPYRITHIONE .2; .5 mL/100mL; mL/100mL E 20171231 66854-025_469199f3-6194-4eda-8351-c99130f06299 66854-025 HUMAN OTC DRUG SPA SKILHA HELIOPROT AB SPF 40 BEMOTRIZINOL,OCTINOXATE,AVOBENZONE,TITANIUM DIOXIDE CREAM TOPICAL 20120630 OTC MONOGRAPH FINAL part352 SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS BEMOTRIZINOL; OCTINOXATE; AVOBENZONE; TITANIUM DIOXIDE 1.5; 7.5; 4; 2 g/100g; g/100g; g/100g; g/100g E 20171231 66854-026_3aa210bd-65ec-411f-9328-2dc7ae4cd504 66854-026 HUMAN OTC DRUG DERMAPROT HELIOPROT AB SPF 30 OCTINOXATE,TITANIUM DIOXIDE,OXYBENZONE,AVOBENZONE LOTION TOPICAL 20120630 OTC MONOGRAPH FINAL part352 SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OXYBENZONE 7.5; 3; 2.5; 1.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 66869-104_21454751-2e90-4beb-b0c3-2f8710bbfbb3 66869-104 HUMAN PRESCRIPTION DRUG Livalo pitavastatin calcium TABLET, FILM COATED ORAL 20100515 NDA NDA022363 Kowa Pharmaceuticals America, Inc. PITAVASTATIN CALCIUM 1.045 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 66869-137_ab2842bc-7364-495f-b2e0-58a2c0df5273 66869-137 HUMAN PRESCRIPTION DRUG LIPOFEN fenofibrate CAPSULE ORAL 20071001 NDA NDA021612 Kowa Pharmaceuticals America Inc. FENOFIBRATE 50 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 66869-147_ab2842bc-7364-495f-b2e0-58a2c0df5273 66869-147 HUMAN PRESCRIPTION DRUG LIPOFEN fenofibrate CAPSULE ORAL 20071001 NDA NDA021612 Kowa Pharmaceuticals America Inc. FENOFIBRATE 150 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 66869-204_21454751-2e90-4beb-b0c3-2f8710bbfbb3 66869-204 HUMAN PRESCRIPTION DRUG Livalo pitavastatin calcium TABLET, FILM COATED ORAL 20100515 NDA NDA022363 Kowa Pharmaceuticals America, Inc. PITAVASTATIN CALCIUM 2.09 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 66869-404_21454751-2e90-4beb-b0c3-2f8710bbfbb3 66869-404 HUMAN PRESCRIPTION DRUG Livalo pitavastatin calcium TABLET, FILM COATED ORAL 20100515 NDA NDA022363 Kowa Pharmaceuticals America, Inc. PITAVASTATIN CALCIUM 4.18 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 66885-051_0d6e7a06-4e62-4cb8-852c-45d7fd2ff32c 66885-051 HUMAN OTC DRUG KELSAN Antimicrobial Ltion Skin Cleanser Chloroxylenol LIQUID TOPICAL 20000630 OTC MONOGRAPH NOT FINAL part333E Kel-San, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 66885-080_84e9f759-f827-44ad-aa1e-920e651d4253 66885-080 HUMAN OTC DRUG BRIGHT SOLUTIONS Foaming Antimicrobial So ap Chloroxylenol LIQUID TOPICAL 20070830 OTC MONOGRAPH NOT FINAL part333E Kel-San, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 66885-081_456c698d-4180-40fa-9549-e8dc782283a2 66885-081 HUMAN OTC DRUG BRIGHT SOLUTIONS Antimicrobial Foam So ap Chloroxylenol LIQUID TOPICAL 20070830 OTC MONOGRAPH NOT FINAL part333E Kel-San, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 66885-400_e3b13ff5-1e4a-4846-a55b-f312b35ba1a1 66885-400 HUMAN OTC DRUG BRIGHT SOLUTIONS Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Kel-San, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 66887-001_4364eb35-6963-4713-a88f-23caab2fb348 66887-001 HUMAN PRESCRIPTION DRUG Testim testosterone GEL TRANSDERMAL 20021031 NDA NDA021454 Endo Pharmaceuticals, Inc. TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 66887-003_7e756d9d-2038-44d8-b2f4-b50bc95518fa 66887-003 HUMAN PRESCRIPTION DRUG XIAFLEX collagenase clostridium histolyticum KIT 20100222 BLA BLA125338 Endo Pharmaceuticals, Inc. N 20181231 66887-004_196a8521-b0e0-4bda-868d-d2342192e43b 66887-004 HUMAN PRESCRIPTION DRUG Testopel testosterone PELLET SUBCUTANEOUS 20141031 ANDA ANDA080911 Endo Pharmaceuticals, Inc. TESTOSTERONE 75 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 66894-0000_b0a72b13-14a5-4086-a05c-6c9a515374ce 66894-0000 HUMAN OTC DRUG Country Gent SODIUM FLUORIDE POWDER, DENTIFRICE DENTAL 20120101 OTC MONOGRAPH FINAL part355 Heavenly Harvest, Inc. SODIUM FLUORIDE 1.88 mg/g E 20171231 66897-001_6013ee03-4bc5-6d9d-e053-2a91aa0a8115 66897-001 HUMAN OTC DRUG Wong To Yick External Analgesic Camphor Menthol Methyl Salicylate OIL TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part348 Wicsun Trading Inc CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 1; 1.6; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 66897-002_c53860a3-0adc-4741-80ef-21e6470466ee 66897-002 HUMAN OTC DRUG Easy Menthol PATCH TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part348 Wicsun Trading MENTHOL 4 g/1 N 20181231 66897-003_2ddbd651-6eff-4b7e-a4f9-c6c519dcc833 66897-003 HUMAN OTC DRUG Herbalgy Camphor Menthol Methyl Salicylate OIL TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part348 Wicsun Trading CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 16; 31.5 mL/100mL; mL/100mL; mL/100mL N 20181231 66898-100_efcea474-f352-4b6f-8859-f9faece1f41f 66898-100 HUMAN OTC DRUG Herbalgy Camphor Menthol Methyl Salicylate OIL TOPICAL 20120315 OTC MONOGRAPH NOT FINAL part348 Herbalgy Pharmaceutical Limited CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 10; 16; 31.5 mL/100mL; mL/100mL; mL/100mL N 20181231 66902-000_63543250-0b90-4d14-98a1-3869738d2822 66902-000 HUMAN OTC DRUG Fast Freeze CAMPHOR (NATURAL), Menthol GEL TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part348 Natural Essentials Inc. CAMPHOR (NATURAL); MENTHOL 2; 35 mg/g; mg/g E 20171231 66902-001_48c1d301-036a-4610-b82c-555aef7e382d 66902-001 HUMAN OTC DRUG Fast Freeze CAMPHOR (NATURAL), MENTHOL SPRAY TOPICAL 20100401 OTC MONOGRAPH NOT FINAL part348 Natural Essentials Inc. CAMPHOR (NATURAL); MENTHOL 2; 100 mg/g; mg/g E 20171231 66902-014_54eef129-c1b0-45b5-b6c4-86e3b9ad55e5 66902-014 HUMAN OTC DRUG ZIMS MAX FREEZE MENTHOL GEL TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC. MENTHOL 37 mg/mL N 20191231 66902-015_a002aea7-72b8-4e17-ab97-fbcd04967874 66902-015 HUMAN OTC DRUG Fast Freeze MENTHOL SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Natural Essentials Inc. MENTHOL 100 mg/g E 20171231 66902-016_f78e1578-1fb0-4096-b299-64d661f911a9 66902-016 HUMAN OTC DRUG Fast Freeze Menthol GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Natural Essentials Inc. MENTHOL 35 mg/g E 20171231 66902-090_ce737959-f445-4b13-ae6f-cee1f9bd13a7 66902-090 HUMAN OTC DRUG Evels Secret Natural Pain Relief Daredevil Strength Menthol GEL TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC. MENTHOL 100 mg/mL E 20171231 66902-113_21134cd7-2481-40d7-af0b-6844a7089fb3 66902-113 HUMAN OTC DRUG ZIMS MAX FREEZE MENTHOL, LIDOCAINE and MENTHYL SALICYLATE PATCH TRANSDERMAL 20160101 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC. MENTHOL; LIDOCAINE; MENTHYL SALICYLATE, (+/-)- 50; 40; .4 mg/1; mg/1; mg/1 E 20171231 66902-165_a6e37537-90e9-4edd-9a7c-cf0b91deba1c 66902-165 HUMAN OTC DRUG ICY FREEZE MENTHOL GEL TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC. MENTHOL 35 mg/mL N 20181231 66902-203_56755eb0-0ac8-4122-af1a-f58ebae747f4 66902-203 HUMAN OTC DRUG CVS Pain Relief LIDOCAINE PATCH TRANSDERMAL 20171201 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC. LIDOCAINE 40 mg/1 N 20181231 66902-213_bebbb8fb-5814-4bc4-a324-9cf943ac9d37 66902-213 HUMAN OTC DRUG ZIMS MAX FREEZE MENTHOL and LIDOCAINE PATCH TRANSDERMAL 20160101 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC. MENTHOL; LIDOCAINE 10; 40 mg/1; mg/1 E 20171231 66902-228_0a8f4510-8190-412d-90bc-d74df8cf65b9 66902-228 HUMAN OTC DRUG ZIMS ADVANCED CRACK CREME WITH HYDROCORTISONE HYDROCORTISONE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC. HYDROCORTISONE 10 mg/L E 20171231 66902-229_517b8c41-6282-48da-a136-d6e13464f26a 66902-229 HUMAN OTC DRUG ZIMS ADVANCED HYDROCORTISONE CONTINUOUS WITH ORGANIC ARNICA AND ALOE HYDROCORTISONE SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC. HYDROCORTISONE 10 g/L N 20191231 66902-230_361d0eb2-d22d-43f6-b2b7-248d9f590b70 66902-230 HUMAN OTC DRUG ZIMS LIDO FREEZE MENTHOL, UNSPECIFIED FORM and LIDOCAINE GEL TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC MENTHOL, UNSPECIFIED FORM; LIDOCAINE 10; 40 mg/mL; mg/mL E 20171231 66902-416_e9450a3d-cc18-4f37-845c-f1c79197092f 66902-416 HUMAN OTC DRUG Zims Max Freeze Continuous MENTHOL SPRAY TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 Natural Essentials Inc. MENTHOL 37 mg/g N 20191231 66902-700_afec96f0-c8b9-4a16-98e4-d4820590b4cb 66902-700 HUMAN OTC DRUG ZIMS ARNICA MAX MENTHOL GEL TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 NATURAL ESSENTIALS, INC. MENTHOL 20 g/L E 20171231 66902-800_a506d6a5-03e8-4a45-a7c3-32387aead9da 66902-800 HUMAN OTC DRUG ZIMS ADVANCED ACEMANNAN AND ARNICA ALLANTOIN GEL TOPICAL 20140101 OTC MONOGRAPH FINAL part347 NATURAL ESSENTIALS, INC. ALLANTOIN 5.5 g/L N 20191231 66908-051_95f48a3c-628c-4ff9-b830-c4ec11f62c85 66908-051 HUMAN OTC DRUG PRO-LINK Prestige Antibacterial Gold Hand So ap Chloroxylenol LIQUID TOPICAL 20000530 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 66908-052_4960a2c0-a437-4474-aae7-d9157b16f2d2 66908-052 HUMAN OTC DRUG Antiseptic Ltion Cleanser Chloroxylenol LIQUID TOPICAL 20040330 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 66908-053_4af4e49c-7792-42fc-a33b-55eb38948c28 66908-053 HUMAN OTC DRUG ProFormance Series Antibacterial Triclosan LIQUID TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Pro-Link, Inc. TRICLOSAN .3 mL/100mL E 20171231 66908-080_59fa7d06-a4d1-4b82-a0fc-1498eb57bde9 66908-080 HUMAN OTC DRUG PRO-LINK OPTIMUM Foaming Antimicrobial So ap Chloroxylenol LIQUID TOPICAL 20021130 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 66908-081_3c0ca629-6d54-4686-b848-836dcba6e7b8 66908-081 HUMAN OTC DRUG PRO-LINK Free Hands Antibacterial Foam So ap Chloroxylenol LIQUID TOPICAL 20060530 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 66908-082_1cd64213-33c7-4c40-9274-a0117e472882 66908-082 HUMAN OTC DRUG PRO-LINK Foaming Antimicrobial So ap Chloroxylenol LIQUID TOPICAL 20060630 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 66908-096_d8e0d011-9d9a-4525-93fd-4966504c74c9 66908-096 HUMAN OTC DRUG PRO-LINK OPTIMUM Foaming Medicated Handwash Triclosan LIQUID TOPICAL 20040530 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. TRICLOSAN .003 mg/mL N 20181231 66908-106_44a94ac1-9eef-4b78-8064-3c27f6ec0f13 66908-106 HUMAN OTC DRUG ProFormance Series Foam Non-Alcohol Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Pro-Link, Inc. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 66908-107_987b5df0-f88f-4d4b-af0b-19322ee90618 66908-107 HUMAN OTC DRUG ProFormance Series Foam Alcohol Hand Sanitizer Ethyl Alcohol LIQUID TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. ALCOHOL 72 mL/100mL E 20171231 66908-400_09237ef5-e287-451f-8d5a-95447a31ce70 66908-400 HUMAN OTC DRUG PRO-LINK Antibacterial Plum Perfection Foam So ap Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 66908-532_3b1cffd1-cee3-4874-85fb-dd6d1c88f4f1 66908-532 HUMAN OTC DRUG Proformance Antibacterial Triclosan LIQUID TOPICAL 20130705 OTC MONOGRAPH NOT FINAL part333A Pro-Link, Inc. TRICLOSAN .3 mg/100mL E 20171231 66908-607_2bddd511-0b6b-4e61-934e-f89f56cdb9d9 66908-607 HUMAN OTC DRUG PRO-LINK OPTIMUM Foam Hand Sanitizer without Alcohol BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. BENZALKONIUM CHLORIDE .0013 mg/mL N 20181231 66908-700_61103ae7-7cfa-4d03-ba29-277eb248af68 66908-700 HUMAN OTC DRUG Proformance Foam Alcohol Sanitizer Ethyl Alcohol LIQUID TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. ALCOHOL 70 mL/100mL E 20171231 66908-965_266d0d35-6c68-4ee2-bda1-5a95d3f4d86c 66908-965 HUMAN OTC DRUG PRO-LINK Hand Sanitizer ALCOHOL GEL TOPICAL 20000530 OTC MONOGRAPH NOT FINAL part333E Pro-Link, Inc. ALCOHOL .62 mL/mL N 20181231 66910-050_4a96a309-aa9c-4b78-bf39-8f38d0620a86 66910-050 HUMAN OTC DRUG DON Sensi-Derm Plus Antibacterial Ltn So ap Chloroxylenol LIQUID TOPICAL 20030830 OTC MONOGRAPH NOT FINAL part333E Edward Don & Company CHLOROXYLENOL .003 mg/mL N 20181231 66910-400_30921ad9-3e81-42f4-ad55-b50e2d0b6392 66910-400 HUMAN OTC DRUG DON Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Edward Don & Company BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 66910-521_7d4af637-12c5-481e-8322-59e932da9f5d 66910-521 HUMAN OTC DRUG DON Antibacterial Blue Floral Foam Handwash CHLOROXYLENOL LIQUID TOPICAL 20141115 OTC MONOGRAPH NOT FINAL part333E Edward Don & Company CHLOROXYLENOL .005 mg/mL N 20181231 66915-301_62995181-4667-5fcd-e053-2a91aa0a6518 66915-301 HUMAN OTC DRUG Stiptik Ferric Subsulfate SOLUTION TOPICAL 20141014 20180430 UNAPPROVED DRUG OTHER Island Kinetics, Inc. d.b.a. CoValence Laboratories FERRIC SUBSULFATE 1 g/g N 20191231 66923-104_d6df64fa-4656-4c9b-9159-63a9c8e28b6c 66923-104 HUMAN OTC DRUG Complete Health Anticavity Fluoride Fresh Mint Sodium Fluoride RINSE ORAL 20150731 OTC MONOGRAPH FINAL part355 Ranir LLC SODIUM FLUORIDE .0219 g/mL N 20181231 66923-235_2cfe81ab-e2af-4fd8-81f1-1074d260daa7 66923-235 HUMAN OTC DRUG UltraCare Alcohol Free Fresh Mint Sodium Fluoride MOUTHWASH ORAL 20150731 OTC MONOGRAPH FINAL part355 Ranir LLC SODIUM FLUORIDE .1 mg/mL N 20181231 66923-406_92842690-217a-4066-87e0-2204a474a932 66923-406 HUMAN OTC DRUG Abridge Cold Sore Treatment Benzalkonium Chloride CREAM TOPICAL 20110331 OTC MONOGRAPH NOT FINAL part333A Ranir LLC BENZALKONIUM CHLORIDE 1.3 mg/g N 20181231 66923-407_7ee416e0-d9e0-42b5-a3c7-c59c8c1813af 66923-407 HUMAN OTC DRUG Abridge Cold Sore Treatment Camphor CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Ranir LLC CAMPHOR (SYNTHETIC); BENZALKONIUM CHLORIDE 30; 1.3 mg/g; mg/g N 20181231 66923-429_adfcd64f-9a2a-44f3-b05a-7847a7a21a86 66923-429 HUMAN OTC DRUG Anticavity Fluoride Sodium Fluoride MOUTHWASH ORAL 20160315 OTC MONOGRAPH FINAL part355 Ranir LLC SODIUM FLUORIDE .1 mg/mL N 20181231 66944-001_af841143-97c4-4b26-87c3-bcf4b79042a3 66944-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020130 UNAPPROVED MEDICAL GAS Halifax Medical Equipment OXYGEN 99 L/100L E 20171231 66949-052_40f7fe84-0c6f-43c9-e054-00144ff8d46c 66949-052 HUMAN OTC DRUG Zep Professional Mild Antimicrobial Hand Cleaner Triclosan LIQUID TOPICAL 20091005 20190101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-100_5f48aac3-dcda-f254-e053-2991aa0aca5d 66949-100 HUMAN OTC DRUG Zep Clean Ems Triclosan LIQUID TOPICAL 20100201 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN 1.5 g/100g N 20181231 66949-109_407c56be-d2bd-4ea9-e054-00144ff8d46c 66949-109 HUMAN OTC DRUG Zep Professional Alcohol Hand Sanitizing Ethanol LIQUID TOPICAL 20090407 OTC MONOGRAPH NOT FINAL part333A Zep Inc. ALCOHOL 6 mL/10mL N 20181231 66949-112_2f2e9c05-a945-42ff-b220-8414b2e97070 66949-112 HUMAN OTC DRUG Zep Professional E-2 Hand Cleaner Benzalkonium Chloride LIQUID TOPICAL 20090407 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL E 20171231 66949-206_40e3e011-2d89-1bc0-e054-00144ff8d46c 66949-206 HUMAN OTC DRUG Zep Professional Tranquil Meadows Triclosan LIQUID TOPICAL 20091005 20190101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-207_40f5abba-803a-4382-e054-00144ff8d46c 66949-207 HUMAN OTC DRUG Zep Professional Z-Verdant Foaming Triclosan LIQUID TOPICAL 20090608 20190101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-210_0ba7caaf-35b1-4923-8321-3d0c8bd777e5 66949-210 HUMAN OTC DRUG Zep Professional Healthcare Worker Triclosan LIQUID TOPICAL 20091005 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL E 20171231 66949-246_5a45a8ee-5c68-aacc-e053-2a91aa0a6690 66949-246 HUMAN OTC DRUG Zep Instant Hand Sanitizer Ethanol LIQUID TOPICAL 20040129 OTC MONOGRAPH NOT FINAL part333A Zep Inc. ALCOHOL 6 mL/10mL N 20181231 66949-248_407bc06c-5c1a-433a-e054-00144ff88e88 66949-248 HUMAN OTC DRUG Zep Non Alcohol Foam Sanitizer Benzethonium Chloride LIQUID TOPICAL 20110714 OTC MONOGRAPH NOT FINAL part333E Zep, Inc BENZETHONIUM CHLORIDE .02 g/10mL N 20181231 66949-252_5a073197-6ca1-e89b-e053-2a91aa0a313f 66949-252 HUMAN OTC DRUG Zep Anti-Bacterial Foaming Hand Cleaner Triclosan SOAP TOPICAL 20110714 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .1 g/100mL N 20181231 66949-271_41587f34-847e-3c46-e054-00144ff8d46c 66949-271 HUMAN OTC DRUG Zep E-2 Foaming Sanitizing Hand Cleaner Chloroxylenol LIQUID TOPICAL 20111001 20190102 OTC MONOGRAPH NOT FINAL part333E Zep Inc. CHLOROXYLENOL .3 g/10mL N 20181231 66949-277_40b92e12-8e1b-4fd7-e054-00144ff88e88 66949-277 HUMAN OTC DRUG Zep Mango Foaming Triclosan LIQUID TOPICAL 20100201 20190102 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-309_5be9dae7-5983-5ae2-e053-2a91aa0ad24d 66949-309 HUMAN OTC DRUG ZEP ROUND ONE AB Chloroxylenol LIQUID TOPICAL 20170719 OTC MONOGRAPH NOT FINAL part333A Zep Inc. CHLOROXYLENOL .04 g/10mL N 20181231 66949-314_5a59337e-39a0-2ed2-e053-2a91aa0a37e3 66949-314 HUMAN OTC DRUG Zep Acclaim AB Benzalkonium Chloride LIQUID TOPICAL 20161215 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL N 20181231 66949-332_5bbf49af-1eaf-3b6f-e053-2a91aa0a8fe4 66949-332 HUMAN OTC DRUG Zep Blue Sky AB Benzalkonium Chloride LIQUID TOPICAL 20170123 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL N 20181231 66949-333_5bc0b4f2-d0b9-91e6-e053-2a91aa0aac50 66949-333 HUMAN OTC DRUG Zep Mango AB Benzalkonium Chloride LIQUID TOPICAL 20170302 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL N 20181231 66949-338_5a43b329-7da6-b479-e053-2991aa0a7d83 66949-338 HUMAN OTC DRUG Fuzion Antimicrobial Hand Cleaner Benzalkonium Chloride LIQUID TOPICAL 20151208 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL N 20181231 66949-339_5a08d10f-fd0d-2b35-e053-2991aa0a0336 66949-339 HUMAN OTC DRUG Zep Commercial Antibacterial Pear Triclosan LIQUID TOPICAL 20060407 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-357_405433fd-ea76-73f8-e054-00144ff8d46c 66949-357 HUMAN OTC DRUG Zep Alcohol Sanitizer Ethanol LIQUID TOPICAL 20000807 OTC MONOGRAPH NOT FINAL part333A Zep Inc. ALCOHOL 6.2 mL/10mL N 20181231 66949-385_5a92253f-a669-afe2-e053-2991aa0a90cd 66949-385 HUMAN OTC DRUG Zep Applaud AB Chloroxylenol LIQUID TOPICAL 20170310 OTC MONOGRAPH NOT FINAL part333A Zep Inc. CHLOROXYLENOL .03 g/10mL N 20181231 66949-387_5c3c1ab7-96a8-6ca5-e053-2991aa0af2b9 66949-387 HUMAN OTC DRUG Zep Tranq Mdw AB Foam Benzalkonium Chloride LIQUID TOPICAL 20170802 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL N 20181231 66949-388_5a910011-a7a5-d548-e053-2991aa0a93d9 66949-388 HUMAN OTC DRUG Fuzion AB Foam Benzalkonium Chloride LIQUID TOPICAL 20170310 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL N 20181231 66949-393_5bc1cc32-5d19-00a8-e053-2991aa0a0c81 66949-393 HUMAN OTC DRUG ZEP PEAR AB HS Benzalkonium Chloride LIQUID TOPICAL 20170303 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL N 20181231 66949-399_5a59337e-39a0-2ed2-e053-2a91aa0a37e3 66949-399 HUMAN OTC DRUG Zep Professional Mild AB Benzalkonium Chloride LIQUID TOPICAL 20160310 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL N 20181231 66949-410_5a09c199-9385-0a42-e053-2991aa0a91ee 66949-410 HUMAN OTC DRUG Clean ems Hand Cleaner Towels Triclosan LIQUID TOPICAL 20120901 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .025 g/10mL N 20181231 66949-421_318e2416-31e9-3baa-e054-00144ff88e88 66949-421 HUMAN OTC DRUG Zep Sun Screen Towels Oxybenzone LIQUID TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 Zep Inc. OXYBENZONE .05 g/100g N 20181231 66949-429_5cc4c45d-5b72-0912-e053-2991aa0a10a5 66949-429 HUMAN OTC DRUG Zep Handstand Antimicrobial Benzalkonium Chloride LIQUID TOPICAL 20170823 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL N 20181231 66949-517_5a08de04-c863-5430-e053-2a91aa0aa159 66949-517 HUMAN OTC DRUG Zep Provisions Pot and Pan Premium Triclosan LIQUID TOPICAL 20080124 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-539_5bc1cc32-5d19-00a8-e053-2991aa0a0c81 66949-539 HUMAN OTC DRUG ZEP PEAR ANTI-BACTERIAL Benzalkonium Chloride LIQUID TOPICAL 20170315 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL N 20181231 66949-601_5a06d162-6fcd-0d7c-e053-2991aa0a18f4 66949-601 HUMAN OTC DRUG Zep Aspen Triclosan LIQUID TOPICAL 20020314 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-607_5a09101c-c1f3-760a-e053-2991aa0a4a98 66949-607 HUMAN OTC DRUG Zep Provisions Pot and Pan Premium FF Triclosan LIQUID TOPICAL 20080124 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-769_5a073197-6cc8-e89b-e053-2a91aa0a313f 66949-769 HUMAN OTC DRUG Zep Blue Sky Foaming Triclosan LIQUID TOPICAL 20080714 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-874_5a07a11d-62c0-18a6-e053-2991aa0a0c1d 66949-874 HUMAN OTC DRUG Zep Mango Foaming Triclosan LIQUID TOPICAL 20030916 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-875_5a08e1bc-a6b7-164a-e053-2a91aa0a73d8 66949-875 HUMAN OTC DRUG Zep Pear Anti-Bacterial Triclosan LIQUID TOPICAL 20030311 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-878_5a45a8ee-5c68-aacc-e053-2a91aa0a6690 66949-878 HUMAN OTC DRUG Zep Instant Hand Sanitizer Ethanol LIQUID TOPICAL 20040129 OTC MONOGRAPH NOT FINAL part333A Zep Inc. ALCOHOL 6 mL/10mL N 20181231 66949-880_407bc06c-5c1a-433a-e054-00144ff88e88 66949-880 HUMAN OTC DRUG Zep Foam San Benzethonium Chloride LIQUID TOPICAL 20030318 OTC MONOGRAPH NOT FINAL part333E Zep, Inc BENZETHONIUM CHLORIDE .02 g/10mL N 20181231 66949-882_40414a57-cb7b-087b-e054-00144ff88e88 66949-882 HUMAN OTC DRUG Zep Lemongrass Triclosan LIQUID TOPICAL 20120917 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-898_5a0760ea-1069-fd62-e053-2991aa0a4855 66949-898 HUMAN OTC DRUG Zep Cherry Creme Triclosan LIQUID TOPICAL 20030226 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-900_405433fd-ea76-73f8-e054-00144ff8d46c 66949-900 HUMAN OTC DRUG Zep Alcohol Sanitizer Ethanol LIQUID TOPICAL 20000807 OTC MONOGRAPH NOT FINAL part333A Zep Inc. ALCOHOL 6.2 mL/10mL N 20181231 66949-901_5a43b329-7da6-b479-e053-2991aa0a7d83 66949-901 HUMAN OTC DRUG Zep FS Antimicrobial Hand Cleaner Benzalkonium Chloride LIQUID TOPICAL 19930226 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .013 g/10mL N 20181231 66949-920_5a429ca4-8735-d066-e053-2991aa0a89b6 66949-920 HUMAN OTC DRUG Zep E-2 Hand Sanitizing Cleaner Chloroxylenol LIQUID TOPICAL 19880615 OTC MONOGRAPH NOT FINAL part333E Zep Inc. CHLOROXYLENOL .3 g/10mL N 20181231 66949-923_5a073197-6cb4-e89b-e053-2a91aa0a313f 66949-923 HUMAN OTC DRUG Zep Applaud Hand Cleaner Triclosan SOAP TOPICAL 20030226 20190102 OTC MONOGRAPH NOT FINAL part333A Zep Inc. CHLOROXYLENOL; TRICLOSAN .02; .02 g/10mL; g/10mL N 20181231 66949-928_5f4949da-f122-6075-e053-2a91aa0acf94 66949-928 HUMAN OTC DRUG Zepaseptic Chloroxylenol LIQUID TOPICAL 19890420 20200101 OTC MONOGRAPH NOT FINAL part333E Zep Inc. CHLOROXYLENOL .3 g/10mL N 20181231 66949-939_5a09372a-81b9-8493-e053-2991aa0af9c8 66949-939 HUMAN OTC DRUG Zep Round One Hand Cleaner Chloroxylenol LIQUID TOPICAL 19880615 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. CHLOROXYLENOL .04 g/10L N 20181231 66949-947_5f4948aa-c531-72ac-e053-2a91aa0ae206 66949-947 HUMAN OTC DRUG Zep Tranquil Meadows Triclosan LIQUID TOPICAL 20080124 20200101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66949-994_41587f34-847e-3c46-e054-00144ff8d46c 66949-994 HUMAN OTC DRUG Zep E-2 Foaming Sanitizing Hand Cleaner Chloroxylenol LIQUID TOPICAL 20000619 OTC MONOGRAPH NOT FINAL part333E Zep Inc. CHLOROXYLENOL .3 g/10mL N 20181231 66949-996_5a4344d0-c6f1-1864-e053-2a91aa0a6990 66949-996 HUMAN OTC DRUG Zep FS Antimicrobial Foaming Hand Cleaner Benzalkonium Chloride LIQUID TOPICAL 20060412 OTC MONOGRAPH NOT FINAL part333A Zep Inc. BENZALKONIUM CHLORIDE .0013 g/mL N 20181231 66949-999_40f7fe23-6817-43d7-e054-00144ff8d46c 66949-999 HUMAN OTC DRUG Zep Acclaim Triclosan LIQUID TOPICAL 19950329 20190101 OTC MONOGRAPH NOT FINAL part333A Zep Inc. TRICLOSAN .01 g/10mL N 20181231 66961-100_e8869a3f-4e84-41ed-ac29-d41502ee3d8e 66961-100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020212 NDA NDA205865 Victor Welding Supply Company OXYGEN 992 mL/L N 20181231 66961-120_1ffe2a99-f9cb-4e62-87bd-af4018ccf43b 66961-120 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20020212 NDA NDA205866 Victor Welding Supply Company NITROGEN 992 mL/L N 20181231 66966-0001_8d39dce2-67af-4c33-93e3-d8beffaca08e 66966-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020103 UNAPPROVED MEDICAL GAS Riverside Health Equipment OXYGEN 99 L/100L E 20171231 66969-6001_739df1e9-10d8-429d-ba22-a98fa862b6d8 66969-6001 HUMAN OTC DRUG Buenos Dias de Personna original Eucalyptol , Menthol, Methyl Salicylate ,Thymol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 66969-6002_4499bc3c-b193-4581-bea3-3128ae4c63ca 66969-6002 HUMAN OTC DRUG Buenos Dias de Personna mint Eucalyptol, Menthol,Methyl Salicylate, Thymol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 66969-6003_d8d0b131-f60e-426c-b7e6-b8044ddbb35b 66969-6003 HUMAN OTC DRUG Buenos Dias de Personna cool mint Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 66969-6012_a861cd9a-2d37-4861-8270-d8c30bb91e7c 66969-6012 HUMAN OTC DRUG Oral Dent Amber Eucalyptol ,Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetic Limited EUCALYPTOL; THYMOL; METHYL SALICYLATE; MENTHOL .092; .064; .06; .042 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 66969-6013_42347a25-20e2-4347-ac47-8f0d163b3c6e 66969-6013 HUMAN OTC DRUG Oral Dent Fresh Mint Eucalyptol, Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; THYMOL; METHYL SALICYLATE; MENTHOL .092; .064; .06; .042 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 66969-6014_cc3b68a6-d2d9-447d-8015-d740aa16bd12 66969-6014 HUMAN OTC DRUG ORAL-DENT Blue Mint Eucalyptol, Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetic Limited EUCALYPTOL; THYMOL; METHYL SALICYLATE; MENTHOL .092; .064; .06; .042 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 66969-6015_2faeb6db-8f12-448e-b7ad-19b86f506192 66969-6015 HUMAN OTC DRUG Oral Dent Citrus Eucalyptol, Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetic Limited EUCALYPTOL; THYMOL; METHYL SALICYLATE; MENTHOL .092; .064; .06; .042 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 66969-6020_ca0ba7c9-eea2-4ee5-aea6-fa573db38e16 66969-6020 HUMAN OTC DRUG Oral Dent Amber Eucalyptol, Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; THYMOL; METHYL SALICYLATE; MENTHOL .092; .064; .06; .042 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 66969-6021_7f775c60-b6fc-4dae-9a29-bc6b0e4a5ebe 66969-6021 HUMAN OTC DRUG Oral Dent Fresh Mint Eucalyptol, Thymol, Methyl Salicylate , Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; THYMOL; METHYL SALICYLATE; MENTHOL .092; .064; .06; .042 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 66969-6022_00127bd3-c4a8-49d7-ba32-beeab6b018b5 66969-6022 HUMAN OTC DRUG Oral Dent Blue Mint Eucalyptol, Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; THYMOL; METHYL SALICYLATE; MENTHOL .092; .064; .06; .042 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 66969-6023_980e99ae-8be7-48fa-af5f-33972ee3b795 66969-6023 HUMAN OTC DRUG Oral Dent Citrus Eucalyptol, Thymol, Methyl Salicylate, Menthol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; THYMOL; METHYL SALICYLATE; MENTHOL .092; .064; .06; .042 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 66969-6024_68679312-84e8-4e5d-aaca-13625ba89e1d 66969-6024 HUMAN OTC DRUG Buenos Dias de Personna citrus flavour Eucalyptol , Menthol , Methyl Salicylate, Thymol MOUTHWASH ORAL 20130110 OTC MONOGRAPH NOT FINAL part356 International Cosmetics Ltd. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 66975-050_17bc7506-43f4-4dc1-bbdb-5219319b7551 66975-050 HUMAN PRESCRIPTION DRUG Iris 60 Second APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Benco Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 66975-051_2155918e-1ece-4629-9e50-36c2178087f0 66975-051 HUMAN PRESCRIPTION DRUG Iris 60 Second APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Benco Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 66975-052_664e85d9-f4f6-4fe2-94f2-f6c015134dd8 66975-052 HUMAN PRESCRIPTION DRUG Iris 60 Second APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Benco Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 66975-053_c01e22ae-662c-468d-b11d-a095770427cd 66975-053 HUMAN PRESCRIPTION DRUG Iris 60 Second APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Benco Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 66975-054_ce058d22-b967-4679-bae3-338b011c2b9e 66975-054 HUMAN PRESCRIPTION DRUG Iris 60 Second APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Benco Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 66975-101_faf6eda4-7205-48e5-8e03-481e6f997397 66975-101 HUMAN OTC DRUG natural extensions Fragrance- Free Instant Hand Sanitizer Alcohol GEL TOPICAL 20100801 OTC MONOGRAPH NOT FINAL part333E Benco Dental Company ALCOHOL 60 mL/100mL E 20171231 66975-102_c7945e12-602e-451d-aac1-758f0f7de625 66975-102 HUMAN OTC DRUG natural extensions Antibacterial Liquid Hand Wash TRICLOSAN SOAP TOPICAL 20101015 OTC MONOGRAPH NOT FINAL part333E Benco Dental Company TRICLOSAN 3 mL/1000mL E 20171231 66975-103_00a40d27-74a0-4c79-9bae-01054ca1f0e0 66975-103 HUMAN OTC DRUG natural extensions Antibacterial Foaming Hand Wash Triclosan SOAP TOPICAL 20101115 OTC MONOGRAPH NOT FINAL part333E Benco Dental Company TRICLOSAN 3 mL/1000mL E 20171231 66975-350_88c53237-648c-4627-bdaa-cd8592b6abed 66975-350 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g N 20181231 66975-351_4d6a54b0-6731-40f9-8733-f1ac45b4879b 66975-351 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g N 20181231 66975-352_5217c8b7-4542-4a78-b8a0-f56ae101d148 66975-352 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g N 20181231 66975-353_64d73efb-3426-4f98-b40b-cdd248b19dfb 66975-353 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g N 20181231 66975-354_e43ad541-a8ef-4922-8501-e9b1dac09871 66975-354 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g N 20181231 66975-355_e62b3d62-12ff-4bdc-992b-2ef3d00b05e2 66975-355 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g N 20181231 66975-356_7829e8b5-928b-4025-9906-409338270b8f 66975-356 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g N 20181231 66975-357_d129c70f-9030-4ef2-ac29-cf0ee21258eb 66975-357 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g N 20181231 66975-358_8de2239b-72cf-4a01-83e5-cbd4ddd40402 66975-358 HUMAN OTC DRUG BencoCaine Topical Anesthetic Benzocaine GEL DENTAL 20140627 OTC MONOGRAPH NOT FINAL part356 Benco Dental BENZOCAINE 200 mg/g N 20181231 66975-406_1f646f98-7228-4a0f-8e6b-6c3751d390a6 66975-406 HUMAN PRESCRIPTION DRUG Mepivacaine Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088387 Benco Dental MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 66975-415_42255c05-2c21-46bd-927d-6eb39fea56a0 66975-415 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111207 ANDA ANDA088389 Benco Dental LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .02 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 66975-417_d00d0008-bf73-48ef-947e-d219b4468222 66975-417 HUMAN PRESCRIPTION DRUG ARTICAINE Articaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20160404 NDA NDA020971 Benco Dental ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 66975-418_0e7379fa-0045-49ec-8173-f774c402d294 66975-418 HUMAN PRESCRIPTION DRUG ARTICAINE Articaine Hydrochloride and Epinephrine INJECTION, SOLUTION SUBCUTANEOUS 20160404 NDA NDA020971 Benco Dental ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 40; .005 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 66975-425_080c1273-1d45-4b93-b41c-fdc2f8ffa6fc 66975-425 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111207 ANDA ANDA088390 Benco Dental LIDOCAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 66975-600_3ca5b6eb-2ec6-6b60-e054-00144ff8d46c 66975-600 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20120418 ANDA ANDA077789 Benco Dental CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 66977-022_1c718944-86af-4bc3-b7a6-8a8133d274e0 66977-022 HUMAN OTC DRUG Norml Shield dimethicone CREAM TOPICAL 19930201 OTC MONOGRAPH NOT FINAL part356 MPM Medical, Inc. DIMETHICONE 45 mg/g E 20171231 66977-023_a09a309c-075c-4832-8de2-0aa3b9b167d4 66977-023 HUMAN OTC DRUG Anti-Fungal clotrimazole CREAM TOPICAL 20021014 OTC MONOGRAPH FINAL part333C MPM Medical, Inc. CLOTRIMAZOLE 10 mg/g E 20171231 66977-032_89f7bc8e-68b0-4e62-b67c-d1f129513507 66977-032 HUMAN OTC DRUG Antiseptic benzethonium chloride SOLUTION TOPICAL 19970601 OTC MONOGRAPH NOT FINAL part333A MPM Medical, Inc. BENZETHONIUM CHLORIDE 1 mg/mL E 20171231 66977-107_8c4a924e-8f26-4e85-82ed-b9939d1d674c 66977-107 HUMAN OTC DRUG REGENECARE HA lidocaine HCl GEL TOPICAL 20070105 OTC MONOGRAPH NOT FINAL part348 MPM Medical, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/g E 20171231 66977-117_a99d01c1-4e4a-49b9-8b98-35ead76e4c3e 66977-117 HUMAN OTC DRUG REGENECARE HA lidocaine HCl GEL TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part348 MPM Medical, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL E 20171231 66983-350_03df6b7c-3fbc-48ec-b751-a3c729291dfd 66983-350 HUMAN OTC DRUG ThyroSafe Potassium Iodide TABLET ORAL 20020930 ANDA ANDA076350 Recipharm AB (publ) POTASSIUM IODIDE 65 mg/1 N 20181231 66988-100_a6bbb5f3-323e-4288-93af-6a6ce004ca8f 66988-100 HUMAN PRESCRIPTION DRUG Oxygen OXYGEN GAS RESPIRATORY (INHALATION) 20100614 UNAPPROVED MEDICAL GAS Jenco Medical and Mobility, Inc OXYGEN 1 L/L E 20171231 66992-281_5df96a45-cadf-9612-e053-2a91aa0a2b6a 66992-281 HUMAN OTC DRUG Entex T Guaifenesin and Pseudoephedrine Hydrochloride TABLET ORAL 20100930 OTC MONOGRAPH FINAL part341 WraSer Pharmaceuticals, LLC GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 375; 60 mg/1; mg/1 N 20181231 66992-340_e87737f3-85f9-4e86-b66a-a59765b77611 66992-340 HUMAN PRESCRIPTION DRUG Trezix acetaminophen, caffeine, dihydrocodeine bitartrate CAPSULE ORAL 20090901 ANDA ANDA040688 WraSer LLC ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 320.5; 30; 16 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 66992-399_1a5d7233-4453-42a5-8144-a4276db39660 66992-399 HUMAN PRESCRIPTION DRUG Regimex benzphetamine hydrochloride TABLET ORAL 20130201 ANDA ANDA090473 Wraser Pharmaceuticals BENZPHETAMINE HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII E 20171231 66992-450_57886307-6dac-442f-9009-042696c0b61d 66992-450 HUMAN PRESCRIPTION DRUG CETRAXAL Ciprofloxacin SOLUTION/ DROPS AURICULAR (OTIC) 20090514 NDA NDA021918 Wraser Llc CIPROFLOXACIN HYDROCHLORIDE .5 mg/.25mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 66992-471_4a82373a-0c5a-4c88-8f22-437bb6103a21 66992-471 HUMAN PRESCRIPTION DRUG ProFeno fenoprofen calcium TABLET, FILM COATED ORAL 20170929 ANDA ANDA072267 Wraser LLC FENOPROFEN CALCIUM 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66992-490_768fad6d-02fa-4c77-b3ee-dc890b77bf1c 66992-490 HUMAN OTC DRUG VAZOBID-PD Brompheniramine maleate and Phenylephrine hydrochloride LIQUID ORAL 20111201 OTC MONOGRAPH FINAL part341 Wraser Pharmaceuticals BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 1.2; 2 mg/mL; mg/mL E 20171231 66992-840_4b3990f3-7004-47e7-bd50-fd771ebf2151 66992-840 HUMAN PRESCRIPTION DRUG Trezix acetaminophen, caffeine, dihydrocodeine bitartrate CAPSULE ORAL 20141201 ANDA ANDA204785 WraSer LLC ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 320.5; 30; 16 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 66992-955_6029e7de-7f3a-4602-96cc-5f9ec67c86fc 66992-955 HUMAN PRESCRIPTION DRUG Phrenilin Forte Butalbital, Acetaminophen, Caffeine CAPSULE ORAL 20170918 ANDA ANDA206615 Wraser LLC BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 300; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 66993-021_d1a209d1-389d-4722-9598-dbd96d52fb28 66993-021 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride Levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20120820 NDA AUTHORIZED GENERIC NDA020837 Prasco Laboratories LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 66993-022_d1a209d1-389d-4722-9598-dbd96d52fb28 66993-022 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20120820 NDA AUTHORIZED GENERIC NDA020837 Prasco Laboratories LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 66993-023_d1a209d1-389d-4722-9598-dbd96d52fb28 66993-023 HUMAN PRESCRIPTION DRUG Levalbuterol hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20120820 NDA AUTHORIZED GENERIC NDA020837 Prasco Laboratories LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 66993-025_73f4ef96-b08d-43ee-9ef2-fc99894c2c00 66993-025 HUMAN PRESCRIPTION DRUG Desmopressin Acetate DESMOPRESSIN ACETATE SPRAY NASAL 20140101 NDA AUTHORIZED GENERIC NDA021333 Prasco Laboratories DESMOPRESSIN ACETATE 10 ug/.1mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 66993-040_d3eb9324-f3a5-4191-b4eb-413b4b770951 66993-040 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine hydrochloride CAPSULE ORAL 20170530 NDA AUTHORIZED GENERIC NDA021411 Prasco Laboratories ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 66993-041_d3eb9324-f3a5-4191-b4eb-413b4b770951 66993-041 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine hydrochloride CAPSULE ORAL 20170530 NDA AUTHORIZED GENERIC NDA021411 Prasco Laboratories ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 66993-042_d3eb9324-f3a5-4191-b4eb-413b4b770951 66993-042 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine hydrochloride CAPSULE ORAL 20170530 NDA AUTHORIZED GENERIC NDA021411 Prasco Laboratories ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 66993-043_d3eb9324-f3a5-4191-b4eb-413b4b770951 66993-043 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine hydrochloride CAPSULE ORAL 20170530 NDA AUTHORIZED GENERIC NDA021411 Prasco Laboratories ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 66993-044_d3eb9324-f3a5-4191-b4eb-413b4b770951 66993-044 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine hydrochloride CAPSULE ORAL 20170530 NDA AUTHORIZED GENERIC NDA021411 Prasco Laboratories ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 66993-045_d3eb9324-f3a5-4191-b4eb-413b4b770951 66993-045 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine hydrochloride CAPSULE ORAL 20170530 NDA AUTHORIZED GENERIC NDA021411 Prasco Laboratories ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 66993-046_d3eb9324-f3a5-4191-b4eb-413b4b770951 66993-046 HUMAN PRESCRIPTION DRUG Atomoxetine Atomoxetine hydrochloride CAPSULE ORAL 20170530 NDA AUTHORIZED GENERIC NDA021411 Prasco Laboratories ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 66993-057_049277f1-31fd-4eb7-959a-1c8a0ebcfd1b 66993-057 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET ORAL 20141212 NDA AUTHORIZED GENERIC NDA009768 Prasco Laboratories HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 66993-060_e8aec800-0fbb-4be8-b716-e3a9e50c4511 66993-060 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil HCl atovaquone and proguanil hydrochloride TABLET, FILM COATED ORAL 20120727 NDA AUTHORIZED GENERIC NDA021078 Prasco Laboratories ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 66993-062_37e3a900-bf57-45b9-a03a-d0a3d6c15245 66993-062 HUMAN PRESCRIPTION DRUG Atovaquone atovaquone SUSPENSION ORAL 20140320 NDA AUTHORIZED GENERIC NDA020500 Prasco Laboratories ATOVAQUONE 750 mg/5mL Antimalarial [EPC],Antiprotozoal [EPC] N 20191231 66993-066_cec79079-bcf0-46e5-aa3e-f90e77fa4a89 66993-066 HUMAN PRESCRIPTION DRUG Phenoxybenzamine Hydrochloride Phenoxybenzamine Hydrochloride CAPSULE ORAL 20150811 NDA AUTHORIZED GENERIC NDA008708 Prasco Laboratories PHENOXYBENZAMINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 66993-067_34c0c3cc-7ce9-4365-aaf1-48afef6c8e32 66993-067 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20150501 ANDA ANDA202038 Prasco Laboratories PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 66993-068_34c0c3cc-7ce9-4365-aaf1-48afef6c8e32 66993-068 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20150501 ANDA ANDA202038 Prasco Laboratories PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 66993-070_4c465fbc-86a1-4f85-bbad-56505346ffa8 66993-070 HUMAN PRESCRIPTION DRUG Mefenamic Acid Mefenamic Acid CAPSULE ORAL 19670328 NDA AUTHORIZED GENERIC NDA015034 Prasco Laboratories MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 66993-090_430adfa1-d2da-491c-adb3-cd7c74f7cae9 66993-090 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid TABLET ORAL 20100517 NDA AUTHORIZED GENERIC NDA022430 Prasco Laboratories TRANEXAMIC ACID 650 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 66993-114_e0d8dd85-037f-4cf2-92eb-adf7e72894b8 66993-114 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141022 NDA AUTHORIZED GENERIC NDA021416 Prasco Laboratories PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] N 20181231 66993-115_e0d8dd85-037f-4cf2-92eb-adf7e72894b8 66993-115 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141022 NDA AUTHORIZED GENERIC NDA021416 Prasco Laboratories PROPAFENONE HYDROCHLORIDE 325 mg/1 Antiarrhythmic [EPC] N 20181231 66993-116_e0d8dd85-037f-4cf2-92eb-adf7e72894b8 66993-116 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride SR propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20141022 NDA AUTHORIZED GENERIC NDA021416 Prasco Laboratories PROPAFENONE HYDROCHLORIDE 425 mg/1 Antiarrhythmic [EPC] N 20181231 66993-121_a2b02c92-a449-4624-9936-423a9c0993e2 66993-121 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid TABLET ORAL 20100517 NDA AUTHORIZED GENERIC NDA022430 Prasco Laboratories TRANEXAMIC ACID 650 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 66993-165_05d25b8e-f303-42aa-8fbc-0b0cfab5c691 66993-165 HUMAN PRESCRIPTION DRUG Colchicine Colchicine TABLET, FILM COATED ORAL 20150112 NDA AUTHORIZED GENERIC NDA022352 Prasco Laboratories COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] N 20191231 66993-185_ec729b40-778d-4045-8af2-4bbe335de014 66993-185 HUMAN PRESCRIPTION DRUG Doxercalciferol doxercalciferol CAPSULE, LIQUID FILLED ORAL 20140114 NDA AUTHORIZED GENERIC NDA020862 Prasco Laboratories DOXERCALCIFEROL .5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] E 20171231 66993-186_ec729b40-778d-4045-8af2-4bbe335de014 66993-186 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE, LIQUID FILLED ORAL 20140114 NDA AUTHORIZED GENERIC NDA020862 Prasco Laboratories DOXERCALCIFEROL 1 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] E 20171231 66993-187_b21ad877-298b-432d-b16c-0123968da751 66993-187 HUMAN PRESCRIPTION DRUG Doxercalciferol doxercalciferol CAPSULE, LIQUID FILLED ORAL 20140114 NDA AUTHORIZED GENERIC NDA020862 Prasco Laboratories DOXERCALCIFEROL 2.5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] E 20171231 66993-407_7e0185ae-26be-4dab-b2c5-1da8f9bb6aff 66993-407 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20111215 NDA AUTHORIZED GENERIC NDA020712 Prasco Laboratories CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 66993-408_7e0185ae-26be-4dab-b2c5-1da8f9bb6aff 66993-408 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20111215 NDA AUTHORIZED GENERIC NDA020712 Prasco Laboratories CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 66993-409_7e0185ae-26be-4dab-b2c5-1da8f9bb6aff 66993-409 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20111215 NDA AUTHORIZED GENERIC NDA020712 Prasco Laboratories CARBAMAZEPINE 300 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 66993-410_22ff580c-e26b-4f25-a874-63fd6b016a2d 66993-410 HUMAN PRESCRIPTION DRUG Mesalamine mesalamine CAPSULE ORAL 19930510 NDA NDA020049 Prasco Laboratories MESALAMINE 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 66993-411_22ff580c-e26b-4f25-a874-63fd6b016a2d 66993-411 HUMAN PRESCRIPTION DRUG Mesalamine mesalamine CAPSULE ORAL 20040708 NDA NDA020049 Prasco Laboratories MESALAMINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 66993-412_091bd0ba-b3a9-4cfe-b680-ae8ff1f105e0 66993-412 HUMAN PRESCRIPTION DRUG omeprazole/sodium bicarbonate omeprazole, sodium bicarbonate CAPSULE ORAL 20060227 NDA AUTHORIZED GENERIC NDA021849 Prasco Laboratories OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 66993-413_091bd0ba-b3a9-4cfe-b680-ae8ff1f105e0 66993-413 HUMAN PRESCRIPTION DRUG omeprazole/sodium bicarbonate omeprazole, sodium bicarbonate CAPSULE ORAL 20060227 NDA AUTHORIZED GENERIC NDA021849 Prasco Laboratories OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 66993-416_b1f499df-53e2-4772-b890-d8aef480975a 66993-416 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium GRANULE ORAL 20130726 NDA AUTHORIZED GENERIC NDA021409 Prasco Laboratories MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 66993-417_24090323-27a8-4a2d-a79d-38dc54e97d9b 66993-417 HUMAN PRESCRIPTION DRUG Raloxifene hydrochloride Raloxifene hydrochloride TABLET ORAL 20140301 20180630 NDA AUTHORIZED GENERIC NDA020815 Prasco Laboratories RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 66993-418_58b44ec3-b0d7-45ec-aeb5-78f1df83014c 66993-418 HUMAN PRESCRIPTION DRUG lansoprazole, amoxicillin and clarithromycin lansoprazole, amoxicillin and clarithromycin KIT 20150303 NDA AUTHORIZED GENERIC NDA050757 Prasco Laboratories N 20181231 66993-422_fd492237-6483-423b-aa2a-37c2dcf9f890 66993-422 HUMAN PRESCRIPTION DRUG Lanthanum carbonate LANTHANUM CARBONATE TABLET, CHEWABLE ORAL 20170830 NDA AUTHORIZED GENERIC NDA021468 Prasco Laboratories LANTHANUM CARBONATE 500 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 66993-423_fd492237-6483-423b-aa2a-37c2dcf9f890 66993-423 HUMAN PRESCRIPTION DRUG Lanthanum carbonate LANTHANUM CARBONATE TABLET, CHEWABLE ORAL 20170830 NDA AUTHORIZED GENERIC NDA021468 Prasco Laboratories LANTHANUM CARBONATE 750 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 66993-424_fd492237-6483-423b-aa2a-37c2dcf9f890 66993-424 HUMAN PRESCRIPTION DRUG Lanthanum carbonate LANTHANUM CARBONATE TABLET, CHEWABLE ORAL 20170830 NDA AUTHORIZED GENERIC NDA021468 Prasco Laboratories LANTHANUM CARBONATE 1000 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 66993-471_4db2bd6d-1c9e-4fc1-8097-0bbaf31ae1e2 66993-471 HUMAN PRESCRIPTION DRUG Nitrofurantoin nitrofurantoin SUSPENSION ORAL 20110816 NDA AUTHORIZED GENERIC NDA009175 Prasco Laboratories NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] E 20171231 66993-472_f04c055f-ffa0-4b23-83b8-abca0e452779 66993-472 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120227 NDA AUTHORIZED GENERIC NDA020356 Prasco Laboratories NISOLDIPINE 8.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 66993-473_f04c055f-ffa0-4b23-83b8-abca0e452779 66993-473 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120227 NDA AUTHORIZED GENERIC NDA020356 Prasco Laboratories NISOLDIPINE 17 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 66993-475_f04c055f-ffa0-4b23-83b8-abca0e452779 66993-475 HUMAN PRESCRIPTION DRUG Nisoldipine Nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120227 NDA AUTHORIZED GENERIC NDA020356 Prasco Laboratories NISOLDIPINE 34 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 66993-478_7a16b7b6-411f-420b-b83a-aa218a5744cb 66993-478 HUMAN PRESCRIPTION DRUG Lamivudine lamivudine TABLET, FILM COATED ORAL 20140905 NDA AUTHORIZED GENERIC NDA021003 Prasco Laboratories LAMIVUDINE 100 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 66993-482_704acc32-038d-4b75-907d-96e4f5839ea4 66993-482 HUMAN PRESCRIPTION DRUG Abacavir and Lamivudine abacavir sulfate and lamivudine TABLET, FILM COATED ORAL 20160929 NDA AUTHORIZED GENERIC NDA021652 Prasco Laboratories ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 66993-485_cac42cc3-792c-4b76-a398-c4961fea3018 66993-485 HUMAN PRESCRIPTION DRUG Zileuton Zileuton TABLET, EXTENDED RELEASE ORAL 20170329 NDA AUTHORIZED GENERIC NDA022052 Prasco, LLC ZILEUTON 600 mg/1 5-Lipoxygenase Inhibitor [EPC],5-Lipoxygenase Inhibitors [MoA],Decreased Leukotriene Production [PE] N 20181231 66993-489_5e1a4e0b-d686-420b-e053-2a91aa0a57ee 66993-489 HUMAN PRESCRIPTION DRUG Dactinomycin Dactinomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171204 NDA AUTHORIZED GENERIC NDA050682 Prasco Laboratories DACTINOMYCIN .5 mg/mL Actinomycin [EPC],Nucleic Acid Synthesis Inhibitors [MoA],Protein Synthesis Inhibitors [MoA] N 20181231 66993-490_4e16fde5-0851-56a9-e054-00144ff8d46c 66993-490 HUMAN PRESCRIPTION DRUG Ibuprofen Lysine ibuprofen lysine SOLUTION INTRAVENOUS 20160414 NDA AUTHORIZED GENERIC NDA021903 Prasco Laboratories IBUPROFEN LYSINE 10 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 66993-575_025a28e2-e7ed-4855-aa54-f1cb79dc13d5 66993-575 HUMAN PRESCRIPTION DRUG Prasugrel Prasugrel hydrochloride TABLET, FILM COATED ORAL 20170815 NDA AUTHORIZED GENERIC NDA022307 Prasco Laboratories PRASUGREL HYDROCHLORIDE 5 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 66993-576_025a28e2-e7ed-4855-aa54-f1cb79dc13d5 66993-576 HUMAN PRESCRIPTION DRUG Prasugrel Prasugrel hydrochloride TABLET, FILM COATED ORAL 20170815 NDA AUTHORIZED GENERIC NDA022307 Prasco Laboratories PRASUGREL HYDROCHLORIDE 10 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 66993-580_5f3a8995-d2ea-4dde-bf81-fab6bdc41767 66993-580 HUMAN PRESCRIPTION DRUG Dutasteride and Tamsulosin Hydrochloride dutasteride and tamsulosin hydrochloride CAPSULE ORAL 20160701 NDA AUTHORIZED GENERIC NDA022460 Prasco Laboratories DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE .5; .4 mg/1; mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA],Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 66993-594_411025e8-e841-4792-ad8b-6c7c7c8d6205 66993-594 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Prasco Laboratories DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 66993-595_411025e8-e841-4792-ad8b-6c7c7c8d6205 66993-595 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Prasco Laboratories DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 66993-596_411025e8-e841-4792-ad8b-6c7c7c8d6205 66993-596 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Prasco Laboratories DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 66993-597_411025e8-e841-4792-ad8b-6c7c7c8d6205 66993-597 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Prasco Laboratories DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 66993-598_411025e8-e841-4792-ad8b-6c7c7c8d6205 66993-598 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Prasco Laboratories DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 6.25; 6.25; 6.25; 6.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 66993-599_411025e8-e841-4792-ad8b-6c7c7c8d6205 66993-599 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE ORAL 20090402 NDA AUTHORIZED GENERIC NDA021303 Prasco Laboratories DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 66993-661_0011f9e5-cf8d-4c48-bd17-a0b2a6fdaa57 66993-661 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20150828 ANDA ANDA204310 Prasco Laboratories RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 66993-662_c7a04f26-6625-4764-92e9-de718e22b4e3 66993-662 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Prasco Laboratories DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 66993-663_c7a04f26-6625-4764-92e9-de718e22b4e3 66993-663 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Prasco Laboratories DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 66993-664_c7a04f26-6625-4764-92e9-de718e22b4e3 66993-664 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Prasco Laboratories DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 66993-680_31dde2ff-6bbe-469c-a266-68b31c4133fb 66993-680 HUMAN PRESCRIPTION DRUG OLANZAPINE olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Prasco Laboratories OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 66993-681_31dde2ff-6bbe-469c-a266-68b31c4133fb 66993-681 HUMAN PRESCRIPTION DRUG OLANZAPINE olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Prasco Laboratories OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 66993-682_31dde2ff-6bbe-469c-a266-68b31c4133fb 66993-682 HUMAN PRESCRIPTION DRUG OLANZAPINE Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Prasco Laboratories OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 66993-683_31dde2ff-6bbe-469c-a266-68b31c4133fb 66993-683 HUMAN PRESCRIPTION DRUG OLANZAPINE Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Prasco Laboratories OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 66993-684_31dde2ff-6bbe-469c-a266-68b31c4133fb 66993-684 HUMAN PRESCRIPTION DRUG OLANZAPINE Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Prasco Laboratories OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 66993-685_31dde2ff-6bbe-469c-a266-68b31c4133fb 66993-685 HUMAN PRESCRIPTION DRUG OLANZAPINE Olanzapine TABLET ORAL 20120423 ANDA ANDA202050 Prasco Laboratories OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 66993-686_9c2af960-f698-489b-9503-b9feac628913 66993-686 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140515 ANDA ANDA203708 Prasco Laboratories OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 66993-687_9c2af960-f698-489b-9503-b9feac628913 66993-687 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140515 ANDA ANDA203708 Prasco Laboratories OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 66993-688_9c2af960-f698-489b-9503-b9feac628913 66993-688 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140515 ANDA ANDA203708 Prasco Laboratories OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 66993-689_9c2af960-f698-489b-9503-b9feac628913 66993-689 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20140515 ANDA ANDA203708 Prasco Laboratories OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 66993-709_e824ee51-909c-4e74-9166-b92ba192ee30 66993-709 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20010112 NDA AUTHORIZED GENERIC NDA021208 Prasco Laboratories MIRTAZAPINE 15 mg/1 E 20171231 66993-711_e824ee51-909c-4e74-9166-b92ba192ee30 66993-711 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20010112 NDA AUTHORIZED GENERIC NDA021208 Prasco Laboratories MIRTAZAPINE 30 mg/1 E 20171231 66993-712_e824ee51-909c-4e74-9166-b92ba192ee30 66993-712 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20010112 NDA AUTHORIZED GENERIC NDA021208 Prasco Laboratories MIRTAZAPINE 45 mg/1 E 20171231 66993-726_6bd7a996-9403-480f-9a23-859a23cd4f08 66993-726 HUMAN PRESCRIPTION DRUG Omega-3-acid ethyl esters omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20160331 NDA AUTHORIZED GENERIC NDA021654 Prasco Laboratories OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 66993-776_7cb04c56-8ab5-46fd-8914-e6d0431acc84 66993-776 HUMAN PRESCRIPTION DRUG Clonidine hydrochloride extended-release clonidine hydrochloride TABLET, EXTENDED RELEASE ORAL 20160620 NDA AUTHORIZED GENERIC NDA022331 Prasco Laboratories CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 66993-815_b3587676-4561-41c6-ae63-7e12b05b415b 66993-815 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20150401 NDA AUTHORIZED GENERIC NDA050805 Prasco Laboratories DOXYCYCLINE 40 mg/1 N 20181231 66993-821_ebc5da9b-2185-4f20-b5cc-7530ebe3bc63 66993-821 HUMAN PRESCRIPTION DRUG pioglitazone and glimepiride pioglitazone and glimepiride TABLET ORAL 20150804 NDA NDA021925 Prasco Laboratories PIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE 30; 2 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 66993-822_ebc5da9b-2185-4f20-b5cc-7530ebe3bc63 66993-822 HUMAN PRESCRIPTION DRUG pioglitazone and glimepiride pioglitazone and glimepiride TABLET ORAL 20150804 NDA NDA021925 Prasco Laboratories PIOGLITAZONE HYDROCHLORIDE; GLIMEPIRIDE 30; 4 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 66993-839_6bd7a996-9403-480f-9a23-859a23cd4f08 66993-839 HUMAN PRESCRIPTION DRUG Omega-3-acid ethyl esters omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20150306 NDA AUTHORIZED GENERIC NDA021654 Prasco Laboratories OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 66993-844_929bc192-6a76-4d6e-ada3-f2f4c9d008a1 66993-844 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING ORAL 20151021 NDA AUTHORIZED GENERIC NDA021959 Prasco Laboratories PREDNISOLONE SODIUM PHOSPHATE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66993-845_929bc192-6a76-4d6e-ada3-f2f4c9d008a1 66993-845 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate ODT prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING ORAL 20151021 NDA AUTHORIZED GENERIC NDA021959 Prasco Laboratories PREDNISOLONE SODIUM PHOSPHATE 15 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66993-846_929bc192-6a76-4d6e-ada3-f2f4c9d008a1 66993-846 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate prednisolone sodium phosphate TABLET, ORALLY DISINTEGRATING ORAL 20151021 NDA AUTHORIZED GENERIC NDA021959 Prasco Laboratories PREDNISOLONE SODIUM PHOSPHATE 30 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66993-869_0b7e4a98-52af-4f19-9b13-1a9238d9811b 66993-869 HUMAN PRESCRIPTION DRUG Adapalene and Benzoyl Peroxide adapalene and benzoyl peroxide GEL TOPICAL 20170803 NDA AUTHORIZED GENERIC NDA022320 Prasco Laboratories ADAPALENE; BENZOYL PEROXIDE 1; 25 mg/g; mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 66993-877_409e4264-72f7-4812-b1ba-85694c2fa49c 66993-877 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene CREAM TOPICAL 19961001 NDA AUTHORIZED GENERIC NDA020554 Prasco Laboratories CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 66993-878_3a49a2dc-2de8-4e26-996e-c47ba63d08b8 66993-878 HUMAN PRESCRIPTION DRUG calcipotriene calcipotriene OINTMENT TOPICAL 20130701 NDA AUTHORIZED GENERIC NDA020273 Prasco Laboratories CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 66993-884_e049ad64-5d7a-4abd-83e5-54ca72c6000b 66993-884 HUMAN PRESCRIPTION DRUG ADAPALENE ADAPALENE GEL TOPICAL 20140101 NDA AUTHORIZED GENERIC NDA021753 Prasco Laboratories ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 66993-894_da3bdbe7-4354-412c-b561-a5e844dc323a 66993-894 HUMAN PRESCRIPTION DRUG ACITRETIN acitretin CAPSULE ORAL 20130719 NDA AUTHORIZED GENERIC NDA019821 Prasco Laboratories ACITRETIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 66993-896_da3bdbe7-4354-412c-b561-a5e844dc323a 66993-896 HUMAN PRESCRIPTION DRUG ACITRETIN acitretin CAPSULE ORAL 20130719 NDA AUTHORIZED GENERIC NDA019821 Prasco Laboratories ACITRETIN 25 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 66993-897_2441390b-9fb7-4ceb-80a5-816a780613a4 66993-897 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate betamethasone dipropionate OINTMENT TOPICAL 20120515 NDA AUTHORIZED GENERIC NDA018741 Prasco Laboratories BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 66993-898_7552bec8-4f90-4440-9003-5a4519b65224 66993-898 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM TOPICAL 19840710 NDA NDA018827 Prasco Laboratories CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 66993-934_60e444ef-a954-4709-99da-49c76957a6d1 66993-934 HUMAN PRESCRIPTION DRUG Testosterone testosterone GEL TRANSDERMAL 20140609 NDA AUTHORIZED GENERIC NDA021454 Prasco Laboratories TESTOSTERONE 50 mg/5g Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 66993-936_0754a778-0116-4bff-bc85-99c8360b06c1 66993-936 HUMAN PRESCRIPTION DRUG metronidazole metronidazole GEL TOPICAL 20050630 NDA AUTHORIZED GENERIC NDA021789 Prasco Laboratories METRONIDAZOLE 10 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 66993-949_25e2e29d-8dae-487d-92e2-e98a8476a2cd 66993-949 HUMAN PRESCRIPTION DRUG Clindamycin - Benzoyl Peroxide clindamycin phosphate and benzoyl peroxide GEL TOPICAL 20120627 NDA AUTHORIZED GENERIC NDA050741 Prasco Laboratories CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE 10; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 66993-960_72be44dd-2614-4740-8abe-70028a3b98a8 66993-960 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE CREAM TOPICAL 20090618 NDA AUTHORIZED GENERIC NDA020531 Prasco Laboratories METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 66993-961_d33d4f77-8570-429d-bece-9ca9bf580c95 66993-961 HUMAN PRESCRIPTION DRUG metronidazole metronidazole LOTION TOPICAL 20090528 NDA AUTHORIZED GENERIC NDA020901 Prasco Laboratories METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 66993-962_d4f21a62-1180-49d7-bf54-88f3e39bded2 66993-962 HUMAN PRESCRIPTION DRUG Metronidazole Topical Gel metronidazole GEL TOPICAL 20140301 NDA AUTHORIZED GENERIC NDA019737 Prasco Laboratories METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 66993-963_08566789-cae4-4332-b236-7ec29936ab3f 66993-963 HUMAN PRESCRIPTION DRUG TESTOSTERONE testosterone SOLUTION TOPICAL 20170123 NDA AUTHORIZED GENERIC NDA022504 Prasco Laboratories TESTOSTERONE 30 mg/1.5mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 67015-0001_85a526ec-891c-45c9-8e12-287d32e8368f 67015-0001 HUMAN OTC DRUG EAU THERMALE Avene Antirougeurs DAY Redness-relief Soothing BROAD SPECTRUM SPF 25 OCTOCRYLENE, OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20130429 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. OCTOCRYLENE; OCTINOXATE; TITANIUM DIOXIDE 40; 75; 45 mg/mL; mg/mL; mg/mL N 20181231 67015-0002_e4958ec7-562d-43a2-8272-a7ecee89b103 67015-0002 HUMAN OTC DRUG EAU THERMALE Avene Hydrance Optimale Hydrating BROAD SPECTRUM SPF 25 TITANIUM DIOXIDE CREAM TOPICAL 20130429 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo Cosmetique OCTOCRYLENE; OCTINOXATE; TITANIUM DIOXIDE 80; 75; 32 mg/mL; mg/mL; mg/mL E 20171231 67015-0784_1008ff1e-c6d4-4d12-84d6-7b987bab3b1b 67015-0784 HUMAN OTC DRUG Eau Thermale Avene Mineral Ultra-Light Hydrating Sunscreen SPF 50 Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. TITANIUM DIOXIDE; ZINC OXIDE 40; 60 mg/mL; mg/mL N 20181231 67015-0786_27e118d9-e9e1-4bf3-bbac-e298681046f1 67015-0786 HUMAN OTC DRUG Eau Thermale Avene Mineral Light Hydrating Sunscreen SPF 50 Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. TITANIUM DIOXIDE; ZINC OXIDE 40; 60 mg/mL; mg/mL N 20181231 67015-0787_dbe3d62a-b11f-4633-8859-0deb662e4600 67015-0787 HUMAN OTC DRUG Eau Thermale Avene Ultra-Light Hydrating Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 130; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67015-0789_aa72c3c1-3a61-4a41-8dbc-6049cf2576ff 67015-0789 HUMAN OTC DRUG Eau Thermale Avene Ultra-Light Hydrating Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene SPRAY TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 130; 50; 100 mg/g; mg/g; mg/g; mg/g N 20181231 67015-0791_bb924bab-21d3-4a1a-b5fc-87d2364e47c4 67015-0791 HUMAN OTC DRUG Eau Thermale Avene Hydrating Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20150306 OTC MONOGRAPH FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 150; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67015-0832_fe0f02fe-b1c5-4de1-b60c-f4d70c0c004d 67015-0832 HUMAN OTC DRUG Eau Thermale Avene Complexion Correcting Shield Light Mineral Sunscreen SPF 50 Plus Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170228 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. TITANIUM DIOXIDE; ZINC OXIDE 132; 156 mg/mL; mg/mL N 20181231 67015-0833_e30e35c8-80c4-4807-8943-a1fe11ef99ab 67015-0833 HUMAN OTC DRUG Eau Thermale Avene Complexion Correcting Shield Medium Mineral Sunscreen SPF 50 Plus Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170228 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. TITANIUM DIOXIDE; ZINC OXIDE 125; 156 mg/mL; mg/mL N 20181231 67015-0834_765ccaaa-db8c-43e4-b959-107406a47645 67015-0834 HUMAN OTC DRUG Eau Thermale Avene Complexion Correcting Shield Dark Mineral Sunscreen SPF 50 Plus Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170228 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. TITANIUM DIOXIDE; ZINC OXIDE 87; 156 mg/mL; mg/mL N 20181231 67015-0835_c86e28c8-2205-4e70-a822-9c3d5ab88949 67015-0835 HUMAN OTC DRUG Eau Thermale Avene Hydrating Sunscreen Balm SPF 50 Plus Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide STICK TOPICAL 20170228 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 60; 60; 15; 30 mg/g; mg/g; mg/g; mg/g N 20181231 67015-1002_46510d0a-25ca-4cd1-979f-7f1bcd8e14c1 67015-1002 HUMAN OTC DRUG HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo-Cosmetique USA, Inc. TITANIUM DIOXIDE; ZINC OXIDE 1.42; .49 g/10g; g/10g N 20181231 67015-1100_0fd30277-3ae0-4795-b944-0f2a8de90e89 67015-1100 HUMAN OTC DRUG HAUTE PROTECTION High Protection Tinted Compact BROAD SPECTRUM SPF 50 BEIGE TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo Cosmetique TITANIUM DIOXIDE; ZINC OXIDE 18; 4.9 g/100g; g/100g E 20171231 67015-1101_1397c8f4-8832-4f4e-b42c-9d4b2860cdc6 67015-1101 HUMAN OTC DRUG HAUTE PROTECTION High Protection Tinted Compact BROAD SPECTRUM SPF 50 HONEY TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part352 Pierre Fabre Dermo Cosmetique TITANIUM DIOXIDE; ZINC OXIDE 18; 4.9 g/100g; g/100g E 20171231 67024-001_50ac5744-defa-454b-8996-7a33d3d26630 67024-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020308 NDA NDA205712 The Service Center LLC OXYGEN 992 mL/L E 20171231 67038-104_742e3e62-e15e-4778-bc4d-c967bbbd8cc7 67038-104 HUMAN OTC DRUG no zit sherlock acnespot treatment spot treatment SALICYLIC ACID GEL TOPICAL 20101101 OTC MONOGRAPH FINAL part333D Bliss World LLC SALICYLIC ACID 3 mg/15mL E 20171231 67038-105_e6a2b08e-b63d-45b8-b799-3b7e6166225d 67038-105 HUMAN OTC DRUG fabulous face spf 15 AVOBENZONE, HOMOSALATE, OXYBENZONE LOTION TOPICAL 20110601 OTC MONOGRAPH FINAL part352 Bliss World LLC AVOBENZONE; HOMOSALATE; OXYBENZONE 1.5; 4; 1.75 g/50mL; g/50mL; g/50mL E 20171231 67038-106_5217c88c-a43f-4eb9-bcac-62c4a494eafd 67038-106 HUMAN OTC DRUG no zit sherlock acne correcting SALICYLIC ACID GEL TOPICAL 20100401 OTC MONOGRAPH FINAL part333D Bliss World LLC SALICYLIC ACID 1 mL/100mL E 20171231 67038-107_638f3c5c-ea90-4ca1-ab47-418260f4f3e3 67038-107 HUMAN OTC DRUG no zit sherlock acne oil control SALICYLIC ACID CREAM TOPICAL 20100401 OTC MONOGRAPH FINAL part333D Bliss World LLC SALICYLIC ACID 2 mL/100mL E 20171231 67038-108_5bb766ed-4fb7-4356-ac5b-8b14d00a87c5 67038-108 HUMAN OTC DRUG no zit sherlock acne purifying cleanser toner SALICYLIC ACID GEL TOPICAL 20100401 OTC MONOGRAPH FINAL part333D Bliss World LLC SALICYLIC ACID 2 mL/100mL E 20171231 67038-110_50b7ded3-9737-448a-b063-9fdc641373df 67038-110 HUMAN OTC DRUG THE YOUTH AS WE KNOW IT AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20120201 OTC MONOGRAPH FINAL part352 Bliss World LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 1.5; 4; 3.75; 2.5; 1.75 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL E 20171231 67046-004_59778124-19a0-79b5-e053-2991aa0a90d9 67046-004 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160701 ANDA ANDA077955 Contract Pharmacy Services-PA AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67046-005_59778124-19a0-79b5-e053-2991aa0a90d9 67046-005 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160701 ANDA ANDA077955 Contract Pharmacy Services-PA AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67046-006_58ec2343-4c3c-26fa-e053-2a91aa0a4916 67046-006 HUMAN OTC DRUG Pharbedryl Diphenhydramine HCl CAPSULE ORAL 20061011 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 67046-007_58ec2d97-168c-505a-e053-2991aa0a3978 67046-007 HUMAN OTC DRUG Pharbedryl Diphenhydramine HCl CAPSULE ORAL 20061011 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 67046-008_57fa94ed-b29d-456a-e053-2a91aa0af484 67046-008 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Contract Pharmacy Services-PA ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 67046-009_59404085-ac5e-794d-e053-2991aa0abbc5 67046-009 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 Contract Pharmacy Services-PA CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 67046-010_460a2e4d-f1a2-4e08-b2da-f10bc63391db 67046-010 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100216 ANDA ANDA085966 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 67046-011_c958b45e-7ca1-400a-b723-56e8c3aa98d8 67046-011 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 67046-012_460a2e4d-f1a2-4e08-b2da-f10bc63391db 67046-012 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100216 ANDA ANDA085968 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 67046-013_c958b45e-7ca1-400a-b723-56e8c3aa98d8 67046-013 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 67046-014_460a2e4d-f1a2-4e08-b2da-f10bc63391db 67046-014 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100216 ANDA ANDA085971 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 67046-015_460a2e4d-f1a2-4e08-b2da-f10bc63391db 67046-015 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20100216 ANDA ANDA085967 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 67046-016_c958b45e-7ca1-400a-b723-56e8c3aa98d8 67046-016 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 67046-017_c958b45e-7ca1-400a-b723-56e8c3aa98d8 67046-017 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 67046-018_5977d47a-fe44-830e-e053-2a91aa0a9f3d 67046-018 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Contract Pharmacy Services-PA AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67046-019_5977d47a-fe44-830e-e053-2a91aa0a9f3d 67046-019 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Contract Pharmacy Services-PA AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67046-020_0fa44b89-29b3-44c7-b9b2-87fb0c226f5e 67046-020 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 19920731 NDA AUTHORIZED GENERIC NDA019787 Contract Pharmacy Services-PA AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 67046-022_57fa94ed-b29f-456a-e053-2a91aa0af484 67046-022 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19870109 ANDA ANDA071450 Contract Pharmacy Services-PA ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 67046-023_57e5ec6f-f9f1-4462-e053-2a91aa0aa907 67046-023 HUMAN OTC DRUG Pharbetol Regular strength Acetaminophen TABLET ORAL 20070109 OTC MONOGRAPH NOT FINAL part343 Coupler Enterprises ACETAMINOPHEN 325 mg/1 N 20181231 67046-024_6a175aa5-62de-4096-be2d-b0bf66f5e82a 67046-024 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100802 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ACETAMINOPHEN 325 mg/1 E 20171231 67046-025_21cbb0e9-4d1e-4a55-bc5a-a4086ca14356 67046-025 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20100802 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ACETAMINOPHEN 325 mg/1 E 20171231 67046-026_065b4f7d-ec2f-4cdd-bab6-383e3c8a57fb 67046-026 HUMAN OTC DRUG Extra Strength Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20100802 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ACETAMINOPHEN 500 mg/1 E 20171231 67046-027_b74b720d-3692-44f1-ab40-55ff612a95a6 67046-027 HUMAN OTC DRUG Extra Strength Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20100802 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ACETAMINOPHEN 500 mg/1 E 20171231 67046-029_59774c8a-de97-53a6-e053-2991aa0a709f 67046-029 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67046-030_a2d29601-21aa-4e78-a725-6c1ea982e3ac 67046-030 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20100407 ANDA ANDA073025 Contract Pharmacy Services-PA ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 67046-031_b8cfe18e-7328-4832-aff8-0b4b9e715172 67046-031 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20110130 ANDA ANDA077877 Contract Pharmacy Services-PA ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 67046-032_597aa208-96d2-285d-e053-2a91aa0a5249 67046-032 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 Contract Pharmacy Services-PA ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67046-034_59774c8a-de97-53a6-e053-2991aa0a709f 67046-034 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67046-035_59774c8a-de97-53a6-e053-2991aa0a709f 67046-035 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Contract Pharmacy Services-PA AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67046-036_597a9058-59ed-efc7-e053-2a91aa0a78cf 67046-036 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20101020 ANDA ANDA078925 Contract Pharmacy Services-PA AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67046-042_8ab4fb43-045f-4104-bd62-55f8d3bae95a 67046-042 HUMAN PRESCRIPTION DRUG benztropine mesylate benztropine mesylate TABLET ORAL 20100628 ANDA ANDA040103 Contract Pharmacy Services-PA BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 67046-043_8ab4fb43-045f-4104-bd62-55f8d3bae95a 67046-043 HUMAN PRESCRIPTION DRUG benztropine mesylate benztropine mesylate TABLET ORAL 20100628 ANDA ANDA040103 Contract Pharmacy Services-PA BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 67046-044_bcf6a343-36e4-482c-883f-09d020eedf16 67046-044 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20020802 ANDA ANDA075584 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 67046-045_bcf6a343-36e4-482c-883f-09d020eedf16 67046-045 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20020702 ANDA ANDA075584 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 67046-075_9ac9a12c-25a1-4547-8a79-a79f83854dc5 67046-075 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100224 ANDA ANDA075491 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 67046-076_9ac9a12c-25a1-4547-8a79-a79f83854dc5 67046-076 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20100224 ANDA ANDA075491 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 67046-077_59783eee-adc6-3327-e053-2991aa0ab6f5 67046-077 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 67046-078_59783eee-adc6-3327-e053-2991aa0ab6f5 67046-078 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 67046-079_598b0776-3cfd-3044-e053-2a91aa0a6b8d 67046-079 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040322 ANDA ANDA075932 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 67046-081_597a1ea2-7f77-1d9a-e053-2991aa0a94b9 67046-081 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20160829 ANDA ANDA206556 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 67046-082_5a45c22c-dd14-5bd3-e053-2991aa0aaf92 67046-082 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170928 ANDA ANDA077284 Contract Pharmacy Services-PA BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 67046-083_599eccbe-804c-827d-e053-2991aa0a001a 67046-083 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20170920 ANDA ANDA065061 Contract Pharmacy Services-PA CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 67046-084_49a643c3-14ef-4bfd-bb66-be05e1696c7e 67046-084 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20100809 ANDA ANDA063083 Contract Pharmacy Services-PA CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 67046-085_9891d1bd-b662-4242-a01e-8151463bbf2d 67046-085 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE, GELATIN COATED ORAL 20100702 ANDA ANDA065194 Contract Pharmacy Services-PA CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 67046-086_8e06995c-26c9-4ef3-9421-16a2360db628 67046-086 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20100224 ANDA ANDA070541 Contract Pharmacy Services-PA CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 67046-089_4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f 67046-089 HUMAN OTC DRUG Chlorpheniramine maleate Chlorpheniramine maleate TABLET ORAL 20110110 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 67046-092_e041ed3c-36d8-4a51-9ebc-b364be9016a4 67046-092 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20100825 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 67046-093_6747500f-a88c-41bc-8355-cb56a56b6b8f 67046-093 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20100830 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 67046-094_5a43b329-7dd5-b479-e053-2991aa0a7d83 67046-094 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20170928 ANDA ANDA070974 Contract Pharmacy Services-PA CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 67046-095_a0bd2115-4159-4277-84e9-f4d4bb0942c1 67046-095 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20100818 ANDA ANDA070925 Contract Pharmacy Services-PA CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 67046-096_5940711d-71a8-cb7d-e053-2a91aa0aef18 67046-096 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20091023 ANDA ANDA077272 Contract Pharmacy Services-PA CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 67046-097_598dd7ef-5049-c6dd-e053-2991aa0a87a2 67046-097 HUMAN OTC DRUG Chlorpheniramine Maleate Chlorpheniramine Maleate TABLET ORAL 20170919 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 67046-098_854c5011-1abf-4ce8-bc8f-65cd02483c72 67046-098 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20100729 ANDA ANDA070317 Contract Pharmacy Services-PA CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 67046-099_59b6c299-a9d0-22fd-e053-2a91aa0a6286 67046-099 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20170921 ANDA ANDA076273 Contract Pharmacy Services-PA CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 67046-100_598e28ee-0a2b-3ccc-e053-2991aa0a0a56 67046-100 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel bisulphate TABLET, FILM COATED ORAL 20170919 ANDA ANDA202925 Contract Pharmacy Services-PA CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 67046-101_598cc779-06bf-b27a-e053-2a91aa0a0909 67046-101 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20170919 ANDA ANDA077042 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67046-102_598cc779-06bf-b27a-e053-2a91aa0a0909 67046-102 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20170919 ANDA ANDA077042 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67046-103_533f3ed8-4569-48e2-95ee-efe428896b8d 67046-103 HUMAN PRESCRIPTION DRUG chlorpromazine hydrochloride chlorpromazine hydrochloride TABLET, SUGAR COATED ORAL 20100225 ANDA ANDA084113 Contract Pharmacy Services-PA CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 67046-104_533f3ed8-4569-48e2-95ee-efe428896b8d 67046-104 HUMAN PRESCRIPTION DRUG chlorpromazine hydrochloride chlorpromazine hydrochloride TABLET, SUGAR COATED ORAL 20100225 ANDA ANDA084114 Contract Pharmacy Services-PA CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 67046-105_59b94f04-42a1-2100-e053-2991aa0ab8f1 67046-105 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20170921 ANDA ANDA078597 Contract Pharmacy Services-PA DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67046-106_598cc779-06bf-b27a-e053-2a91aa0a0909 67046-106 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20170919 ANDA ANDA077042 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67046-107_dce6a871-db80-4b59-9b30-ff970a05fa35 67046-107 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100630 ANDA ANDA077289 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-108_dce6a871-db80-4b59-9b30-ff970a05fa35 67046-108 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100630 ANDA ANDA077289 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-109_dce6a871-db80-4b59-9b30-ff970a05fa35 67046-109 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100630 ANDA ANDA077289 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-110_34d1685a-8e6a-46bc-8977-550979bf4ddd 67046-110 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20100701 ANDA ANDA078216 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-111_30abc373-2373-449c-9bb1-b22238402357 67046-111 HUMAN PRESCRIPTION DRUG Perrigo Citalopram Citalopram TABLET ORAL 20100225 ANDA ANDA077042 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-112_653233ce-04c3-4059-9d45-a7075ddbf920 67046-112 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20100406 ANDA ANDA077031 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-113_34d1685a-8e6a-46bc-8977-550979bf4ddd 67046-113 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20100701 ANDA ANDA078216 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-114_34d1685a-8e6a-46bc-8977-550979bf4ddd 67046-114 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20100701 ANDA ANDA078216 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-115_653233ce-04c3-4059-9d45-a7075ddbf920 67046-115 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20100407 ANDA ANDA077031 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-116_b808f809-40fa-43c6-a33f-2ec21a293051 67046-116 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20090901 ANDA ANDA077044 Contract Pharmacy Services-PA CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-117_5a409d46-bea3-1e76-e053-2a91aa0ac626 67046-117 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20170928 ANDA ANDA078048 Contract Pharmacy Services-PA CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67046-118_59ca0395-599c-0d7e-e053-2a91aa0a2c91 67046-118 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20170921 ANDA ANDA085223 Contract Pharmacy Services-PA DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 67046-119_e9063c42-e71a-4cce-9cd9-9ed6a192c6bb 67046-119 HUMAN PRESCRIPTION DRUG cyclobenzaprine hydrochloride cyclobenzaprine hydrochloride TABLET ORAL 20100423 ANDA ANDA077563 Contract Pharmacy Services-PA CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 67046-120_ea1966a2-794c-434e-a9da-57890bd182fc 67046-120 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078182 Contract Pharmacy Services-PA DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 67046-121_ea1966a2-794c-434e-a9da-57890bd182fc 67046-121 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078182 Contract Pharmacy Services-PA DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 67046-122_a24e8e53-07b3-49be-87e4-124f7d3aeac1 67046-122 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100818 ANDA ANDA077567 Contract Pharmacy Services-PA DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 67046-123_59ca0395-599c-0d7e-e053-2a91aa0a2c91 67046-123 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20170921 ANDA ANDA085082 Contract Pharmacy Services-PA DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 67046-124_1b53ec3a-dec0-48c2-831d-72b3d88242f1 67046-124 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20100830 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 67046-125_1d026ead-c3de-4dc6-9d3c-5a603f6dde4e 67046-125 HUMAN OTC DRUG DIPHENDYDRAMINE HYDROCHLORIDE DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20100805 OTC MONOGRAPH FINAL part345 Contract Pharmacy Services-PA DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 67046-126_1d026ead-c3de-4dc6-9d3c-5a603f6dde4e 67046-126 HUMAN OTC DRUG DIPHENDYDRAMINE HYDROCHLORIDE DIPHENDYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20100805 OTC MONOGRAPH FINAL part345 Contract Pharmacy Services-PA DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 E 20171231 67046-127_c3be33a2-b7eb-4826-9c0c-9de24d54c173 67046-127 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE ORAL 20100805 ANDA ANDA080738 Contract Pharmacy Services-PA DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] E 20171231 67046-128_e08dc0ab-3c86-43d4-ab18-ce4212657484 67046-128 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110131 NDA NDA020690 Contract Pharmacy Services-PA DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 67046-129_e08dc0ab-3c86-43d4-ab18-ce4212657484 67046-129 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110131 NDA NDA020690 Contract Pharmacy Services-PA DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 67046-130_59cd0a28-6e63-c3e3-e053-2a91aa0acbeb 67046-130 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20170922 ANDA ANDA062676 Contract Pharmacy Services-PA DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 67046-131_1edc1fca-9ac7-4adf-b894-bf8ca392ce4d 67046-131 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20100406 ANDA ANDA070791 Contract Pharmacy Services-PA DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] E 20171231 67046-132_1edc1fca-9ac7-4adf-b894-bf8ca392ce4d 67046-132 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20100406 ANDA ANDA070791 Contract Pharmacy Services-PA DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] E 20171231 67046-133_1edc1fca-9ac7-4adf-b894-bf8ca392ce4d 67046-133 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20100406 ANDA ANDA070791 Contract Pharmacy Services-PA DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] E 20171231 67046-134_ec5cc9e9-aa3a-4c54-b0a1-de1449701f78 67046-134 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Contract Pharmacy Services-PA DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 67046-135_b34eb07b-d8a7-4762-a457-9d64dd86b205 67046-135 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20100310 ANDA ANDA062396 Contract Pharmacy Services-PA DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 67046-136_ec5cc9e9-aa3a-4c54-b0a1-de1449701f78 67046-136 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Contract Pharmacy Services-PA DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 67046-137_5a04ccc6-8e81-59d6-e053-2a91aa0a67b7 67046-137 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20170925 ANDA ANDA077100 Contract Pharmacy Services-PA DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67046-138_5a04ccc6-8e81-59d6-e053-2a91aa0a67b7 67046-138 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20170925 ANDA ANDA077100 Contract Pharmacy Services-PA DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67046-139_808abf28-a936-4d62-bb94-9fbe51c571c4 67046-139 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20100730 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacy Services-PA DOCUSATE SODIUM 100 mg/1 E 20171231 67046-140_0e96c2fb-21b3-4a49-96fd-51efb872342d 67046-140 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20070122 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacy Services-PA DOCUSATE SODIUM 100 mg/1 E 20171231 67046-141_5a46243e-cff9-9a5c-e053-2a91aa0ab365 67046-141 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20170928 ANDA ANDA090554 Contract Pharmacy Services-PA DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67046-142_59b78f7b-5c73-2a69-e053-2a91aa0aa5e2 67046-142 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20170921 ANDA ANDA077797 Contract Pharmacy Services-PA CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67046-143_5a04842a-c10b-83ac-e053-2991aa0a0a42 67046-143 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20170925 ANDA ANDA078445 Contract Pharmacy Services-PA DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67046-144_598bd4d0-18bd-2542-e053-2991aa0a0762 67046-144 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20170919 ANDA ANDA200292 Contract Pharmacy Services-PA DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 67046-145_59b94f04-42a1-2100-e053-2991aa0ab8f1 67046-145 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20170921 ANDA ANDA078597 Contract Pharmacy Services-PA DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67046-146_5a92534c-5787-af98-e053-2991aa0aa8ca 67046-146 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20171002 ANDA ANDA090070 Contract Pharmacy Services-PA DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67046-147_5a050880-e41b-4d54-e053-2991aa0a6da6 67046-147 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20170925 ANDA ANDA079163 Contract Pharmacy Services-PA DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67046-148_5ad15e86-ea6f-c9a8-e053-2991aa0a2df9 67046-148 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 Coupler Enterprises CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67046-149_598c39b1-0816-5895-e053-2991aa0a53b1 67046-149 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20170919 ANDA ANDA076008 Contract Pharmacy Services-PA BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 67046-150_59b80d0d-6a54-440a-e053-2991aa0ae8e3 67046-150 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20170921 ANDA ANDA203730 Contract Pharmacy Services-PA DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67046-156_66f5c697-4daa-4b5f-8ee2-40fc70960459 67046-156 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20100802 ANDA ANDA075483 Contract Pharmacy Services-PA ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 67046-157_3980589d-98fd-4bf4-9e99-1084bcfd5946 67046-157 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20100407 ANDA ANDA075480 Contract Pharmacy Services-PA ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 67046-158_3980589d-98fd-4bf4-9e99-1084bcfd5946 67046-158 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20100407 ANDA ANDA075480 Contract Pharmacy Services-PA ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 67046-159_3980589d-98fd-4bf4-9e99-1084bcfd5946 67046-159 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20100628 ANDA ANDA075480 Contract Pharmacy Services-PA ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 67046-160_66f5c697-4daa-4b5f-8ee2-40fc70960459 67046-160 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20100802 ANDA ANDA075483 Contract Pharmacy Services-PA ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 67046-161_66f5c697-4daa-4b5f-8ee2-40fc70960459 67046-161 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20100802 ANDA ANDA075483 Contract Pharmacy Services-PA ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 67046-162_579dc7cc-903e-4c51-be12-ba6aa0c3a74e 67046-162 HUMAN OTC DRUG ASPIRIN Aspirin TABLET, FILM COATED ORAL 20100810 OTC MONOGRAPH FINAL part343 Contract Pharmacy Services-PA ASPIRIN 325 mg/1 E 20171231 67046-163_283f3428-3cd4-4f43-92ae-06c4b2ff3f37 67046-163 HUMAN OTC DRUG ASPIRIN LOW DOSE Aspirin TABLET, FILM COATED ORAL 20100817 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ASPIRIN 81 mg/1 E 20171231 67046-164_4f9bd0b1-0836-473d-bf08-b7894984dc59 67046-164 HUMAN OTC DRUG ASPIRIN Aspirin TABLET, FILM COATED ORAL 20101101 OTC MONOGRAPH FINAL part343 Contract Pharmacy Services-PA ASPIRIN 325 mg/1 E 20171231 67046-165_390334bc-5c58-4c43-8d1c-6a9dc017891b 67046-165 HUMAN OTC DRUG ASPIRIN LOW DOSE CHEWABLE Aspirin TABLET, CHEWABLE ORAL 20100809 OTC MONOGRAPH FINAL part343 Contract Pharmacy Services-PA ASPIRIN 81 mg/1 E 20171231 67046-166_466f6fa5-79f9-4f53-971d-a5254b0750e3 67046-166 HUMAN OTC DRUG ASPIRIN LOW DOSE Aspirin TABLET, FILM COATED ORAL 20100809 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ASPIRIN 81 mg/1 E 20171231 67046-167_5af27c8a-9b53-49fd-a518-fa95053b11da 67046-167 HUMAN OTC DRUG ASPIRIN LOW DOSE Aspirin TABLET, FILM COATED ORAL 20100810 OTC MONOGRAPH NOT FINAL part343 Contract Pharmacy Services-PA ASPIRIN 81 mg/1 E 20171231 67046-168_24262441-3582-42b8-853e-6393bef275d1 67046-168 HUMAN OTC DRUG ASPIRIN LOW DOSE Aspirin TABLET, FILM COATED ORAL 20101103 OTC MONOGRAPH FINAL part343 Contract Pharmacy Services-PA ASPIRIN 81 mg/1 E 20171231 67046-169_59c703f4-328b-44fa-e053-2991aa0a3e2e 67046-169 HUMAN OTC DRUG Pharbest Aspirin 325mg Aspirin TABLET, DELAYED RELEASE ORAL 20170922 OTC MONOGRAPH FINAL part343 Contract Pharmacy Services-PA ASPIRIN 325 mg/1 N 20181231 67046-170_598b819f-98ce-8ecf-e053-2a91aa0aeadc 67046-170 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 Contract Pharmacy Services-PA ASPIRIN 325 mg/1 N 20181231 67046-171_5a084ea4-cafd-ffed-e053-2991aa0aa0d9 67046-171 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20170925 ANDA ANDA076765 Contract Pharmacy Services-PA ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67046-172_599f4348-122d-adc9-e053-2a91aa0acd21 67046-172 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20170920 ANDA ANDA075511 Contract Pharmacy Services-PA FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 67046-173_5a058aa9-323a-4ce6-e053-2991aa0a90ea 67046-173 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20170925 NDA NDA021323 Contract Pharmacy Services-PA ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67046-174_5a05b94a-6dda-572e-e053-2a91aa0a660f 67046-174 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20170925 ANDA ANDA090939 Contract Pharmacy Services-PA ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67046-205_e1e31142-4256-4b12-8d2b-29a6cf45dc91 67046-205 HUMAN OTC DRUG Fiber Lax Fiber lax TABLET ORAL 20100809 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacy Services-PA CALCIUM POLYCARBOPHIL 500 mg/1 E 20171231 67046-208_59b56b39-55f8-eb74-e053-2991aa0ae46a 67046-208 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20170921 ANDA ANDA072575 Contract Pharmacy Services-PA PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67046-209_59b56b39-55f8-eb74-e053-2991aa0ae46a 67046-209 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20170921 ANDA ANDA072575 Contract Pharmacy Services-PA PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67046-210_8609ed02-0b30-4c82-bab1-4d51d92ec224 67046-210 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20100730 ANDA ANDA075452 Contract Pharmacy Services-PA FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-211_4e4d8017-9c1d-41eb-affb-8046e3548be9 67046-211 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20100405 ANDA ANDA075245 Contract Pharmacy Services-PA FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-212_a2d6beb9-bec4-4623-bcc9-7f1bfddb9f0b 67046-212 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20110125 ANDA ANDA076001 Contract Pharmacy Services-PA FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-213_598e9653-932e-3bfe-e053-2a91aa0afcbe 67046-213 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20170919 ANDA ANDA078619 Contract Pharmacy Services-PA FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67046-214_592811f2-e230-6a58-e053-2991aa0a69a9 67046-214 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20150730 ANDA ANDA204597 Contract Pharmacy Services-PA FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67046-215_b561a04c-b0a6-4da1-9955-172672f10669 67046-215 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100413 ANDA ANDA080600 Contract Pharmacy Services-PA FOLIC ACID 1 mg/1 E 20171231 67046-216_a5477715-93d0-4240-9a96-c4f47e99604c 67046-216 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20101109 ANDA ANDA040756 Contract Pharmacy Services-PA FOLIC ACID 1 mg/1 E 20171231 67046-219_5a95bc6e-5cef-4813-e053-2a91aa0a8c35 67046-219 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20171002 NDA NDA018487 Contract Pharmacy Services-PA FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 67046-221_54410c7f-83a9-4797-9f81-7ca568130298 67046-221 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110208 ANDA ANDA018413 Contract Pharmacy Services-PA FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 67046-222_aae04ef8-9438-43f4-9418-66b55d7bd7dc 67046-222 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20100412 NDA NDA018569 Contract Pharmacy Services-PA FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 67046-223_9c400666-a559-471f-9024-2f5b24455dee 67046-223 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100719 ANDA ANDA078428 Contract Pharmacy Services-PA GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 67046-224_9c400666-a559-471f-9024-2f5b24455dee 67046-224 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100412 ANDA ANDA078428 Contract Pharmacy Services-PA GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 67046-225_59a01ec3-97d5-c099-e053-2a91aa0af754 67046-225 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170920 ANDA ANDA090858 Contract Pharmacy Services-PA GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67046-226_59a01ec3-97d5-c099-e053-2a91aa0af754 67046-226 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170920 ANDA ANDA090858 Contract Pharmacy Services-PA GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67046-227_33b9c9ba-f71c-49f9-9bfc-f0d8a68aeab6 67046-227 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20090830 ANDA ANDA077662 Contract Pharmacy Services-PA GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 67046-228_1d44526e-563e-4cd2-9625-983d8c31a434 67046-228 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110501 ANDA ANDA078010 Contract Pharmacy Services-PA FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 67046-229_5a963df3-4c2c-71ce-e053-2a91aa0a1501 67046-229 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20171002 ANDA ANDA077662 Contract Pharmacy Services-PA GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67046-230_1c8945d1-2292-4c31-8ba4-19bece8cec8d 67046-230 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20100405 ANDA ANDA074256 Contract Pharmacy Services-PA GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 67046-231_e2ec8e47-8f4e-44cc-82ff-1d4511d3fadd 67046-231 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20101109 ANDA ANDA077836 Contract Pharmacy Services-PA GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 67046-232_59a01ec3-97d5-c099-e053-2a91aa0af754 67046-232 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170920 ANDA ANDA090858 Contract Pharmacy Services-PA GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67046-233_59a0c339-260b-7941-e053-2a91aa0ad5f1 67046-233 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20170920 ANDA ANDA077836 Contract Pharmacy Services-PA GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 67046-234_5a05a77b-ab0e-d3f8-e053-2a91aa0a906f 67046-234 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20170925 ANDA ANDA202764 Contract Pharmacy Services-PA GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67046-235_e1f70f24-1a4d-4861-9917-859bca58b865 67046-235 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20100405 ANDA ANDA074223 Contract Pharmacy Services-PA GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 67046-236_5a094758-dc7a-8136-e053-2a91aa0a20a1 67046-236 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20170925 ANDA ANDA075795 Contract Pharmacy Services-PA GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 67046-237_5a06349d-c4e0-8d22-e053-2a91aa0aa318 67046-237 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20170925 ANDA ANDA074305 Contract Pharmacy Services-PA GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 67046-238_5a05a77b-ab0e-d3f8-e053-2a91aa0a906f 67046-238 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20170925 ANDA ANDA202764 Contract Pharmacy Services-PA GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67046-240_b61ab462-de4d-4ec4-b0b1-5e6863d9279e 67046-240 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20020806 ANDA ANDA076257 Contract Pharmacy Services-PA GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 67046-251_9de5e639-d676-4379-9cb5-d99014ebca6c 67046-251 HUMAN OTC DRUG Guaifenesin GUAIFENESIN TABLET ORAL 20110127 OTC MONOGRAPH FINAL part341 Contract Pharmacy Services-PA GUAIFENESIN 200 mg/1 E 20171231 67046-268_0027b8a3-73bf-4005-a7e3-b035f451a861 67046-268 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20100728 ANDA ANDA070278 Contract Pharmacy Services-PA HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] E 20171231 67046-270_5a939fe6-46b9-afcc-e053-2a91aa0a663a 67046-270 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20171002 ANDA ANDA086242 Contract Pharmacy Services-PA HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 67046-271_e6edac46-8e5d-4180-a35e-510ecd534367 67046-271 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20101109 ANDA ANDA084878 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 67046-272_e6edac46-8e5d-4180-a35e-510ecd534367 67046-272 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20101109 ANDA ANDA084878 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 67046-273_fbd5b7f2-5571-4361-af2b-4149b5f72f03 67046-273 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100309 ANDA ANDA083177 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 67046-274_fbd5b7f2-5571-4361-af2b-4149b5f72f03 67046-274 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100309 ANDA ANDA083177 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 67046-275_fe6200cc-3182-473c-a90a-a8caa2fb2818 67046-275 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100816 ANDA ANDA040702 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 67046-276_fe6200cc-3182-473c-a90a-a8caa2fb2818 67046-276 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20100816 ANDA ANDA040702 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 67046-277_5a40e342-6004-a20c-e053-2a91aa0a472e 67046-277 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20170928 ANDA ANDA040807 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67046-278_5a431eed-b975-701a-e053-2991aa0aa6ee 67046-278 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20170928 ANDA ANDA202556 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67046-279_5a92df4e-30b3-b295-e053-2991aa0ab4a9 67046-279 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20171002 ANDA ANDA204279 Contract Pharmacy Services-PA HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 67046-280_5a939fe6-46b9-afcc-e053-2a91aa0a663a 67046-280 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20171002 ANDA ANDA086242 Contract Pharmacy Services-PA HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 67046-281_2bbcabc3-657f-4b2e-a473-774adfeba78e 67046-281 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20100816 ANDA ANDA087479 Contract Pharmacy Services-PA HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 67046-282_2bbcabc3-657f-4b2e-a473-774adfeba78e 67046-282 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate HYDROXYZINE PAMOATE CAPSULE ORAL 20100816 ANDA ANDA086183 Contract Pharmacy Services-PA HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 67046-283_5ab9d7e2-0c5d-99fd-e053-2991aa0a2370 67046-283 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20171004 ANDA ANDA040156 Contract Pharmacy Services-PA HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 67046-300_b022458f-564e-4b5f-9541-80fadd61b733 67046-300 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100414 ANDA ANDA075682 Contract Pharmacy Services-PA IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67046-302_ebf71efe-e39a-4642-bf3a-e4781360ec7b 67046-302 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20100816 ANDA ANDA072096 Contract Pharmacy Services-PA IBUPROFEN 200 mg/1 E 20171231 67046-303_beec2bfd-1ba9-46b2-84f0-6a47766048e4 67046-303 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20100802 ANDA ANDA072096 Contract Pharmacy Services-PA IBUPROFEN 200 mg/1 E 20171231 67046-306_5abea399-8ee0-7238-e053-2991aa0ae155 67046-306 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20171004 ANDA ANDA090796 Contract Pharmacy Services-PA IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67046-307_5acccf6e-a394-67e5-e053-2a91aa0afb98 67046-307 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20171005 ANDA ANDA078558 Contract Pharmacy Services-PA IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67046-308_b022458f-564e-4b5f-9541-80fadd61b733 67046-308 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100412 ANDA ANDA075682 Contract Pharmacy Services-PA IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67046-309_6f3018fb-cec9-4908-8c70-ceeedd7d240d 67046-309 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20090922 ANDA ANDA075682 Contract Pharmacy Services-PA IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67046-310_6f3018fb-cec9-4908-8c70-ceeedd7d240d 67046-310 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20090922 ANDA ANDA075682 Contract Pharmacy Services-PA IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67046-311_6f3018fb-cec9-4908-8c70-ceeedd7d240d 67046-311 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091001 ANDA ANDA075682 Contract Pharmacy Services-PA IBUPROFEN 800 1/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67046-312_b022458f-564e-4b5f-9541-80fadd61b733 67046-312 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20100414 ANDA ANDA075682 Contract Pharmacy Services-PA IBUPROFEN 800 1/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67046-313_5ace2a78-fb11-a635-e053-2991aa0a4ad2 67046-313 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20171005 ANDA ANDA078558 Contract Pharmacy Services-PA IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67046-314_5ad11b1a-77a1-0ad1-e053-2a91aa0a6f2e 67046-314 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20171005 ANDA ANDA090796 Contract Pharmacy Services-PA IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67046-330_3d5df05a-f4af-48d8-b880-97dfb92e900c 67046-330 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100730 NDA NDA018858 Contract Pharmacy Services-PA INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67046-331_3d5df05a-f4af-48d8-b880-97dfb92e900c 67046-331 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100730 ANDA ANDA070624 Contract Pharmacy Services-PA INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67046-333_ec0df56a-7746-45f2-88dc-a975cf48abc9 67046-333 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20100802 ANDA ANDA080937 Contract Pharmacy Services-PA ISONIAZID 300 mg/1 Antimycobacterial [EPC] E 20171231 67046-350_cd9e04d1-4a0a-4885-9ccb-8a51ff112465 67046-350 HUMAN PRESCRIPTION DRUG Klor-Con Extended-release Potassium Chloride TABLET, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Contract Pharmacy Services-PA POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 67046-420_59cd5863-1c39-df08-e053-2991aa0ab6f7 67046-420 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20170922 ANDA ANDA078154 Contract Pharmacy Services-PA LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67046-421_5a09c199-9403-0a42-e053-2991aa0a91ee 67046-421 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20170925 ANDA ANDA090515 Contract Pharmacy Services-PA LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67046-425_db57a1c8-83d3-4348-85e5-8fe3b950cce5 67046-425 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100812 ANDA ANDA077321 Contract Pharmacy Services-PA LISINOPRIL 10 mg/1 E 20171231 67046-426_350e0a50-2819-4de3-83cf-73c63ac248df 67046-426 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 Contract Pharmacy Services-PA LISINOPRIL 10 mg/1 E 20171231 67046-427_db57a1c8-83d3-4348-85e5-8fe3b950cce5 67046-427 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100812 ANDA ANDA077321 Contract Pharmacy Services-PA LISINOPRIL 20 mg/1 E 20171231 67046-428_350e0a50-2819-4de3-83cf-73c63ac248df 67046-428 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020802 ANDA ANDA075944 Contract Pharmacy Services-PA LISINOPRIL 20 mg/1 E 20171231 67046-430_1bde6fe0-fc5a-4ad5-95a2-71d5ad7824c0 67046-430 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 20100406 NDA NDA017812 Contract Pharmacy Services-PA LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 67046-431_95330e0b-3884-495c-bf57-6bcafebba5e8 67046-431 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20100406 ANDA ANDA076243 Contract Pharmacy Services-PA LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 67046-432_5990e860-306e-1c9a-e053-2a91aa0a2ff3 67046-432 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20170919 ANDA ANDA090702 Contract Pharmacy Services-PA LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 67046-433_5a31bdda-ec17-139c-e053-2991aa0a3c0c 67046-433 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20170927 ANDA ANDA077912 Contract Pharmacy Services-PA HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 67046-449_597cddb1-f7e1-fe1c-e053-2a91aa0aa8b4 67046-449 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA090083 Contract Pharmacy Services-PA LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67046-450_5a966d64-68b6-403b-e053-2991aa0a4417 67046-450 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20171002 ANDA ANDA075636 Contract Pharmacy Services-PA LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67046-451_5a966d64-68b6-403b-e053-2991aa0a4417 67046-451 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20171002 ANDA ANDA075636 Contract Pharmacy Services-PA LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67046-452_5990445c-d523-24cf-e053-2991aa0af4e6 67046-452 HUMAN OTC DRUG Loratadine Allergy Relief Loratadine TABLET ORAL 20170919 ANDA ANDA076134 Contract Pharmacy Services-PA LORATADINE 10 mg/1 N 20181231 67046-453_59905847-f1a6-0dee-e053-2a91aa0aafed 67046-453 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20170919 ANDA ANDA075209 Contract Pharmacy Services-PA LORATADINE 10 mg/1 N 20181231 67046-454_59a421cf-dfab-6685-e053-2a91aa0a9b3f 67046-454 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20170920 ANDA ANDA073192 Contract Pharmacy Services-PA LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 67046-455_597cddb1-f7e1-fe1c-e053-2a91aa0aa8b4 67046-455 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101006 ANDA ANDA090083 Contract Pharmacy Services-PA LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67046-456_59a44282-30f3-103b-e053-2a91aa0a643a 67046-456 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20170920 ANDA ANDA072741 Contract Pharmacy Services-PA LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 67046-458_5a455264-1055-2ddb-e053-2991aa0a66b0 67046-458 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20170928 ANDA ANDA090058 Contract Pharmacy Services-PA MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 67046-459_59a485b1-829a-5d02-e053-2a91aa0a42e3 67046-459 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20170920 ANDA ANDA090564 Contract Pharmacy Services-PA METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67046-460_463f684a-cd09-4b3a-8dca-8398125183fd 67046-460 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100409 ANDA ANDA077064 Contract Pharmacy Services-PA METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 67046-461_463f684a-cd09-4b3a-8dca-8398125183fd 67046-461 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100729 ANDA ANDA077064 Contract Pharmacy Services-PA METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 67046-462_463f684a-cd09-4b3a-8dca-8398125183fd 67046-462 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100729 ANDA ANDA077064 Contract Pharmacy Services-PA METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 67046-463_59a485b1-829a-5d02-e053-2a91aa0a42e3 67046-463 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20170920 ANDA ANDA090564 Contract Pharmacy Services-PA METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67046-464_59a485b1-829a-5d02-e053-2a91aa0a42e3 67046-464 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20170920 ANDA ANDA090564 Contract Pharmacy Services-PA METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67046-465_5a966d64-686c-403b-e053-2991aa0a4417 67046-465 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20171002 ANDA ANDA040489 Contract Pharmacy Services-PA METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67046-466_09721fb9-d3bd-4fc3-be79-79bc653a8289 67046-466 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Contract Pharmacy Services-PA METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 67046-467_396ddbcd-82cb-4ac1-b80d-a00b290ccd0f 67046-467 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20100301 ANDA ANDA090200 Contract Pharmacy Services-PA METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 67046-468_59b9449b-3ad0-39f7-e053-2a91aa0a6db2 67046-468 HUMAN PRESCRIPTION DRUG montelukast sodium montelukast sodium TABLET, FILM COATED ORAL 20170921 ANDA ANDA204290 Contract Pharmacy Services-PA MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 67046-469_5ab92993-5bc1-20f6-e053-2991aa0aa877 67046-469 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20171004 ANDA ANDA076704 Contract Pharmacy Services-PA METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67046-472_59a546ed-8477-a54a-e053-2991aa0a3a0d 67046-472 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20170920 ANDA ANDA076704 Contract Pharmacy Services-PA METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67046-473_5aa4b664-42b7-ee87-e053-2a91aa0ad0c5 67046-473 HUMAN PRESCRIPTION DRUG Metoprolol tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20171003 ANDA ANDA078459 Contract Pharmacy Services-PA METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67046-474_deb70186-796e-4e52-a7e8-afd8c17e637c 67046-474 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20110125 ANDA ANDA078459 Contract Pharmacy Services-PA METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 67046-475_bc1f3dcd-f929-4c16-ac8e-59105fa46c2d 67046-475 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090610 ANDA ANDA073288 Contract Pharmacy Services-PA METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 67046-477_bc1f3dcd-f929-4c16-ac8e-59105fa46c2d 67046-477 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20090610 ANDA ANDA073289 Contract Pharmacy Services-PA METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 67046-478_5aa52c22-f6b9-421c-e053-2991aa0aaf46 67046-478 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20171003 ANDA ANDA076921 Contract Pharmacy Services-PA MIRTAZAPINE 45 mg/1 N 20181231 67046-479_5a1ce60e-977c-1801-e053-2a91aa0adb5e 67046-479 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, FILM COATED ORAL 20170926 ANDA ANDA076219 Contract Pharmacy Services-PA MIRTAZAPINE 15 mg/1 N 20181231 67046-481_912e850f-a0bf-4e07-a800-43479eeffb05 67046-481 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20100630 ANDA ANDA076122 Contract Pharmacy Services-PA MIRTAZAPINE 15 mg/1 E 20171231 67046-482_912e850f-a0bf-4e07-a800-43479eeffb05 67046-482 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20100630 ANDA ANDA076122 Contract Pharmacy Services-PA MIRTAZAPINE 30 mg/1 E 20171231 67046-483_912e850f-a0bf-4e07-a800-43479eeffb05 67046-483 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20100630 ANDA ANDA076122 Contract Pharmacy Services-PA MIRTAZAPINE 45 mg/1 E 20171231 67046-484_5aa52c22-f6b9-421c-e053-2991aa0aaf46 67046-484 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20171003 ANDA ANDA076921 Contract Pharmacy Services-PA MIRTAZAPINE 30 mg/1 N 20181231 67046-489_bc6e059d-1951-4fa3-b904-230d4165724d 67046-489 HUMAN PRESCRIPTION DRUG Namenda memantine hydrochloride TABLET ORAL 20100319 NDA NDA021487 Contract Pharmacy Services-PA MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 67046-499_2c4f826c-e71b-4462-a025-19730701a9de 67046-499 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100319 ANDA ANDA078250 Contract Pharmacy Services-PA NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67046-500_2c4f826c-e71b-4462-a025-19730701a9de 67046-500 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100319 ANDA ANDA078250 Contract Pharmacy Services-PA NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67046-501_2c4f826c-e71b-4462-a025-19730701a9de 67046-501 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100319 ANDA ANDA078250 Contract Pharmacy Services-PA NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67046-505_597c6ed3-d61c-737f-e053-2a91aa0a5b31 67046-505 HUMAN PRESCRIPTION DRUG MELOXICAM meloxicam TABLET ORAL 20060719 ANDA ANDA077929 Contract Pharmacy Services-PA MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67046-506_597c6ed3-d61c-737f-e053-2a91aa0a5b31 67046-506 HUMAN PRESCRIPTION DRUG MELOXICAM meloxicam TABLET ORAL 20060719 ANDA ANDA077929 Contract Pharmacy Services-PA MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67046-515_43062486-bbac-47e4-bae1-16924338c8d8 67046-515 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100413 NDA NDA019684 Contract Pharmacy Services-PA NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 67046-519_598da612-ccb2-7c5d-e053-2a91aa0ae771 67046-519 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20170919 ANDA ANDA076048 Contract Pharmacy Services-PA OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 67046-520_ab5f9512-335f-4490-a6a9-12f611646991 67046-520 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20100309 ANDA ANDA075410 Contract Pharmacy Services-PA OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 67046-522_5a1dc228-b758-5f2b-e053-2991aa0adccc 67046-522 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20170926 ANDA ANDA090798 Contract Pharmacy Services-PA OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 67046-523_5a1dc228-b758-5f2b-e053-2991aa0adccc 67046-523 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20170926 ANDA ANDA090798 Contract Pharmacy Services-PA OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 67046-525_5abc92df-b330-c421-e053-2a91aa0a109d 67046-525 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20171004 ANDA ANDA202862 Contract Pharmacy Services-PA OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 67046-530_32fd11aa-2996-496d-ac3b-76a6afe22e3c 67046-530 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100811 ANDA ANDA077584 Contract Pharmacy Services-PA PAROXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-531_32fd11aa-2996-496d-ac3b-76a6afe22e3c 67046-531 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100811 ANDA ANDA077584 Contract Pharmacy Services-PA PAROXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-532_32fd11aa-2996-496d-ac3b-76a6afe22e3c 67046-532 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100811 ANDA ANDA077584 Contract Pharmacy Services-PA PAROXETINE HYDROCHLORIDE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-533_32fd11aa-2996-496d-ac3b-76a6afe22e3c 67046-533 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine hydrochloride TABLET, FILM COATED ORAL 20100811 ANDA ANDA077584 Contract Pharmacy Services-PA PAROXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-534_59b5bb7c-89cc-4ae6-e053-2991aa0ad7f1 67046-534 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20170921 ANDA ANDA077056 Contract Pharmacy Services-PA PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 67046-535_7c958802-daad-4c7e-88eb-73be7d2261d8 67046-535 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Delayed-Release pantoprazole sodium TABLET, DELAYED RELEASE ORAL 20100226 NDA NDA020987 Contract Pharmacy Services-PA PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 67046-536_58b379ed-8604-4c2d-e053-2991aa0a8919 67046-536 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20120928 ANDA ANDA202038 Contract Pharmacy Services-PA PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 67046-540_f2c7e54b-ed7c-4d8f-a86d-5099a8b52f28 67046-540 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20100407 ANDA ANDA089684 Contract Pharmacy Services-PA PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 67046-541_f2c7e54b-ed7c-4d8f-a86d-5099a8b52f28 67046-541 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20100407 ANDA ANDA089685 Contract Pharmacy Services-PA PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 67046-585_da966d98-94a6-463e-aff7-771406c4c836 67046-585 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20100406 ANDA ANDA040684 Contract Pharmacy Services-PA PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 67046-588_dbd309c5-7205-41e3-b8c4-cb06df375528 67046-588 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20100802 ANDA ANDA074726 Contract Pharmacy Services-PA POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 67046-589_0c0a180b-f4f4-4122-9e29-ac7160a9f519 67046-589 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20100802 ANDA ANDA075604 Contract Pharmacy Services-PA POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 67046-590_dbd309c5-7205-41e3-b8c4-cb06df375528 67046-590 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20100802 ANDA ANDA074726 Contract Pharmacy Services-PA POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 67046-604_e5a90643-3f0e-45a2-a9a4-65229c38d6ab 67046-604 HUMAN PRESCRIPTION DRUG Plavix clopidogrel bisulfate TABLET, FILM COATED ORAL 19990226 NDA NDA020839 Contract Pharmacy Services-PA CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] E 20171231 67046-620_5a1a6ce6-741e-6941-e053-2a91aa0a83e7 67046-620 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20170926 ANDA ANDA202152 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 67046-621_5a1a6ce6-741e-6941-e053-2a91aa0a83e7 67046-621 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20170926 ANDA ANDA202152 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 67046-622_5a1a6ce6-741e-6941-e053-2a91aa0a83e7 67046-622 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20170926 ANDA ANDA202152 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 67046-632_5abd1db3-4f3b-2359-e053-2a91aa0a1a43 67046-632 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20171004 ANDA ANDA201109 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 67046-636_5a19e429-21d1-efd1-e053-2a91aa0acb63 67046-636 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine TABLET ORAL 20170926 ANDA ANDA201109 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 67046-637_5a19e429-21d1-efd1-e053-2a91aa0acb63 67046-637 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine TABLET ORAL 20170926 ANDA ANDA201109 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 67046-638_5a19e429-21d1-efd1-e053-2a91aa0acb63 67046-638 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine TABLET ORAL 20170926 ANDA ANDA201109 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 67046-640_82effea8-5782-4aa5-969e-b635423ae3c6 67046-640 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20101206 ANDA ANDA076228 Contract Pharmacy Services-PA RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-641_82effea8-5782-4aa5-969e-b635423ae3c6 67046-641 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20101206 ANDA ANDA076228 Contract Pharmacy Services-PA RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-642_82effea8-5782-4aa5-969e-b635423ae3c6 67046-642 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20101206 ANDA ANDA076228 Contract Pharmacy Services-PA RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-643_82effea8-5782-4aa5-969e-b635423ae3c6 67046-643 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20101206 ANDA ANDA076228 Contract Pharmacy Services-PA RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-644_82effea8-5782-4aa5-969e-b635423ae3c6 67046-644 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20101206 ANDA ANDA076228 Contract Pharmacy Services-PA RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-645_82effea8-5782-4aa5-969e-b635423ae3c6 67046-645 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20101206 ANDA ANDA076228 Contract Pharmacy Services-PA RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-648_5a1cf9b3-6ad1-0805-e053-2991aa0ab837 67046-648 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20170926 ANDA ANDA078542 Contract Pharmacy Services-PA RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 67046-649_5a1cf9b3-6ad1-0805-e053-2991aa0ab837 67046-649 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20170926 ANDA ANDA078542 Contract Pharmacy Services-PA RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 67046-650_d79fa307-a4fa-4ded-af53-31df482510dc 67046-650 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20100311 ANDA ANDA075180 Contract Pharmacy Services-PA RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 67046-651_5a2caf7d-d5da-493d-e053-2991aa0ae208 67046-651 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20100630 ANDA ANDA077824 Contract Pharmacy Services-PA RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 67046-652_5a2caf7d-d5da-493d-e053-2991aa0ae208 67046-652 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20170927 ANDA ANDA077824 Contract Pharmacy Services-PA RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 67046-653_2e5c6b7f-1d57-4114-9067-79dca009c4cc 67046-653 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20100825 ANDA ANDA078040 Contract Pharmacy Services-PA RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-654_2e5c6b7f-1d57-4114-9067-79dca009c4cc 67046-654 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20100825 ANDA ANDA078040 Contract Pharmacy Services-PA RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-655_2e5c6b7f-1d57-4114-9067-79dca009c4cc 67046-655 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20100825 ANDA ANDA078040 Contract Pharmacy Services-PA RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-656_2e5c6b7f-1d57-4114-9067-79dca009c4cc 67046-656 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20100825 ANDA ANDA078040 Contract Pharmacy Services-PA RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-657_2e5c6b7f-1d57-4114-9067-79dca009c4cc 67046-657 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20100825 ANDA ANDA078040 Contract Pharmacy Services-PA RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-658_2e5c6b7f-1d57-4114-9067-79dca009c4cc 67046-658 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20100825 ANDA ANDA078040 Contract Pharmacy Services-PA RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-660_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d 67046-660 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-661_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d 67046-661 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-662_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d 67046-662 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-663_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d 67046-663 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-664_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d 67046-664 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-665_3e2cb0ae-2284-44d0-9eff-f7d4ab6501a5 67046-665 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 20100315 NDA NDA019839 Contract Pharmacy Services-PA SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67046-666_276e53bf-d3c0-4457-a76e-ee39c1cd2a3d 67046-666 HUMAN PRESCRIPTION DRUG SEROQUEL Quetiapine fumarate TABLET, FILM COATED ORAL 20100601 NDA NDA020639 Contract Pharmacy Services-PA QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] E 20171231 67046-667_59a50c10-50f3-fe8e-e053-2a91aa0a1ad4 67046-667 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20170920 ANDA ANDA077397 Contract Pharmacy Services-PA SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67046-668_597bab7a-3ba1-1083-e053-2a91aa0a9d48 67046-668 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Contract Pharmacy Services-PA SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67046-669_597bc4e7-3544-bd77-e053-2991aa0a7fd4 67046-669 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Contract Pharmacy Services-PA SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67046-670_727b02f3-bcd1-4568-9a0d-7723b6264800 67046-670 HUMAN OTC DRUG Senna-S docusate sodium and sennosides TABLET, FILM COATED ORAL 20100817 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacy Services-PA DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 E 20171231 67046-671_13c80d46-429e-4007-8f89-eed2ed96eccf 67046-671 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20100617 ANDA ANDA077752 Contract Pharmacy Services-PA SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 67046-672_7fce939e-c38e-497f-ba3f-e7b6ba44bfd9 67046-672 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20100825 ANDA ANDA077837 Contract Pharmacy Services-PA SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 67046-674_13c80d46-429e-4007-8f89-eed2ed96eccf 67046-674 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20100617 ANDA ANDA077752 Contract Pharmacy Services-PA SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 67046-675_7fce939e-c38e-497f-ba3f-e7b6ba44bfd9 67046-675 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20100825 ANDA ANDA077837 Contract Pharmacy Services-PA SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 67046-676_597bc4e7-3544-bd77-e053-2991aa0a7fd4 67046-676 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Contract Pharmacy Services-PA SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67046-677_5a06633b-1f84-0ad9-e053-2991aa0a21a7 67046-677 HUMAN OTC DRUG SENNA SENNA TABLET, COATED ORAL 20170925 OTC MONOGRAPH NOT FINAL part334 Contract Pharmacy Services-PA SENNOSIDES A AND B 8.6 mg/1 N 20181231 67046-714_dff887ee-43c7-40fc-9c5f-76014616c461 67046-714 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110114 ANDA ANDA090828 Contract Pharmacy Services-PA SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 67046-715_a03f40f5-068e-41f2-826d-6ed627dd8776 67046-715 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100406 ANDA ANDA078060 Contract Pharmacy Services-PA SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 67046-716_5990dfd1-f8ce-84bf-e053-2a91aa0a8b93 67046-716 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Contract Pharmacy Services-PA SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 67046-717_593f997d-f45d-24ec-e053-2991aa0a4716 67046-717 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20100802 ANDA ANDA091426 Contract Pharmacy Services-PA SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 67046-720_7350ad6e-7745-4743-9aa4-2a14ff01fef4 67046-720 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100728 ANDA ANDA078225 Contract Pharmacy Services-PA TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 67046-721_59a17ad9-3968-16b0-e053-2991aa0a9a40 67046-721 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20170920 ANDA ANDA202433 Contract Pharmacy Services-PA TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67046-728_13a23307-61e4-4094-9132-68e38d200d18 67046-728 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 20100315 ANDA ANDA060704 Contract Pharmacy Services-PA TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 67046-729_592cc647-c396-3e30-e053-2991aa0a506d 67046-729 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 Contract Pharmacy Services-PA TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 67046-730_a1527d3b-85a5-4588-8ce3-533ecb48ab7f 67046-730 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20100226 ANDA ANDA076003 Contract Pharmacy Services-PA TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 67046-731_58118cfd-0a30-2d73-e053-2991aa0a9515 67046-731 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110131 ANDA ANDA090404 Contract Pharmacy Services-PA TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 67046-739_4e0ce52d-2639-42a2-a4e4-7854421fa1b6 67046-739 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20100811 ANDA ANDA072192 Contract Pharmacy Services-PA TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 67046-740_28080f0c-0b6c-4d95-8a53-6474bb876b0e 67046-740 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochoride TABLET ORAL 20100309 ANDA ANDA071523 Contract Pharmacy Services-PA TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 67046-741_28080f0c-0b6c-4d95-8a53-6474bb876b0e 67046-741 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20100309 ANDA ANDA071524 Contract Pharmacy Services-PA TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 67046-742_4e0ce52d-2639-42a2-a4e4-7854421fa1b6 67046-742 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20100811 ANDA ANDA072193 Contract Pharmacy Services-PA TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 67046-805_6541ab19-3cfc-4786-9cfe-0455f428edb5 67046-805 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 20100405 ANDA ANDA073484 Contract Pharmacy Services-PA VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 67046-806_9fbfe4dc-c4df-4911-a440-099c860cb923 67046-806 HUMAN PRESCRIPTION DRUG Valproic Valproic Acid CAPSULE, LIQUID FILLED ORAL 20100405 ANDA ANDA073229 Contract Pharmacy Services-PA VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 67046-807_59b3262c-a564-ccd1-e053-2991aa0a46c6 67046-807 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE, LIQUID FILLED ORAL 20170921 ANDA ANDA073484 Contract Pharmacy Services-PA VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67046-808_597a6144-324c-9533-e053-2991aa0ab896 67046-808 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE, LIQUID FILLED ORAL 20160715 ANDA ANDA073484 Contract Pharmacy Services-PA VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67046-851_59b3e091-0462-1fd1-e053-2991aa0a5ecc 67046-851 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20170921 ANDA ANDA077653 Contract Pharmacy Services-PA VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67046-852_59b3e091-0465-1fd1-e053-2991aa0a5ecc 67046-852 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20170921 ANDA ANDA078554 Contract Pharmacy Services-PA VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67046-901_17b567bb-05c1-4309-b8ea-59009f08abd5 67046-901 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20100216 ANDA ANDA040419 Contract Pharmacy Services-PA ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII E 20171231 67046-902_078eac0c-1589-4c6e-96ca-7543a4c1277e 67046-902 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Contract Pharmacy Services-PA CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 CIII E 20171231 67046-903_5a45c22c-dd1d-5bd3-e053-2991aa0aaf92 67046-903 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170928 ANDA ANDA088628 Contract Pharmacy Services-PA ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 67046-904_5a409d46-bec0-1e76-e053-2a91aa0ac626 67046-904 HUMAN PRESCRIPTION DRUG Clorazepate dipotassium Clorazepate dipotassium TABLET ORAL 20170928 ANDA ANDA076911 Contract Pharmacy Services-PA CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-906_7abac94c-ba0e-415b-9196-72caf153cc7c 67046-906 HUMAN PRESCRIPTION DRUG Clorazepate Dipotassium Clorazepate Dipotassium TABLET ORAL 20110329 ANDA ANDA071858 Contract Pharmacy Services-PA CLORAZEPATE DIPOTASSIUM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-907_5a409d46-bec0-1e76-e053-2a91aa0ac626 67046-907 HUMAN PRESCRIPTION DRUG Clorazepate dipotassium Clorazepate dipotassium TABLET ORAL 20170928 ANDA ANDA076911 Contract Pharmacy Services-PA CLORAZEPATE DIPOTASSIUM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-908_57f985e3-9573-477f-e053-2991aa0a61c9 67046-908 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 Contract Pharmacy Services-PA ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 67046-909_5aa62277-272f-df59-e053-2a91aa0a06a7 67046-909 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20171003 ANDA ANDA083116 Contract Pharmacy Services-PA CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-910_720bb488-30df-4eca-8b5d-87b73272a509 67046-910 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20100407 ANDA ANDA084769 Contract Pharmacy Services-PA CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-911_59b8ea4b-4ac1-9771-e053-2a91aa0af94b 67046-911 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20170921 ANDA ANDA040245 Contract Pharmacy Services-PA CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 67046-912_58113333-a25f-2cd0-e053-2991aa0a35ef 67046-912 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20100515 ANDA ANDA085472 Contract Pharmacy Services-PA CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-914_5a43c270-d2fb-a326-e053-2991aa0a5d95 67046-914 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20170928 ANDA ANDA074569 Contract Pharmacy Services-PA CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-915_52a03dbc-0510-40ec-8a33-15bf1c404622 67046-915 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20100701 ANDA ANDA074869 Contract Pharmacy Services-PA CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-916_5a31a0b1-9123-bbaa-e053-2991aa0ad928 67046-916 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20170927 ANDA ANDA077856 Contract Pharmacy Services-PA CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-917_52a03dbc-0510-40ec-8a33-15bf1c404622 67046-917 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20100701 ANDA ANDA074869 Contract Pharmacy Services-PA CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-918_58af8964-3481-2139-e053-2991aa0a0624 67046-918 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 Contract Pharmacy Services-PA CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-919_52a03dbc-0510-40ec-8a33-15bf1c404622 67046-919 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20100701 ANDA ANDA074869 Contract Pharmacy Services-PA CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-920_5a43c270-d2fb-a326-e053-2991aa0a5d95 67046-920 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20170928 ANDA ANDA074569 Contract Pharmacy Services-PA CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-921_58af8964-3481-2139-e053-2991aa0a0624 67046-921 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 Contract Pharmacy Services-PA CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-922_58af8964-3481-2139-e053-2991aa0a0624 67046-922 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 Contract Pharmacy Services-PA CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-923_5ab980c0-c4c0-233b-e053-2991aa0a4fd1 67046-923 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20171004 ANDA ANDA040823 Contract Pharmacy Services-PA CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67046-925_e45a941e-4f98-43ca-adae-9e1c02f949e4 67046-925 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20110218 ANDA ANDA089883 Contract Pharmacy Services-PA HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67046-926_ab6b4c39-b2d4-4c63-8821-b0560f781287 67046-926 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA089160 Contract Pharmacy Services-PA HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67046-927_deaf83c4-6df1-4f11-82cc-9fed561e8b40 67046-927 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040729 Contract Pharmacy Services-PA HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67046-928_2ebcbba3-36bb-49ec-8625-43d60fb730ee 67046-928 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19881202 ANDA ANDA089971 Contract Pharmacy Services-PA HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67046-929_57f98678-18c0-1790-e053-2991aa0a5eb7 67046-929 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170105 ANDA ANDA202800 Contract Pharmacy Services-PA ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 67046-935_58113333-a25f-2cd0-e053-2991aa0a35ef 67046-935 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20100515 ANDA ANDA085475 Contract Pharmacy Services-PA CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-941_59f7ce6d-5811-40cc-900e-47a5fdb42a98 67046-941 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20110801 ANDA ANDA071135 Contract Pharmacy Services-PA DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-942_59f7ce6d-5811-40cc-900e-47a5fdb42a98 67046-942 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20110329 ANDA ANDA071136 Contract Pharmacy Services-PA DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-943_59b78f7b-5cd2-2a69-e053-2a91aa0aa5e2 67046-943 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20170921 ANDA ANDA071321 Contract Pharmacy Services-PA DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-944_59b78f7b-5cd2-2a69-e053-2a91aa0aa5e2 67046-944 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20170921 ANDA ANDA071322 Contract Pharmacy Services-PA DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-945_59b78f7b-5cd2-2a69-e053-2a91aa0aa5e2 67046-945 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20170921 ANDA ANDA071307 Contract Pharmacy Services-PA DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-946_58af1a75-4acc-0506-e053-2991aa0a738f 67046-946 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071135 Contract Pharmacy Services-PA DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-947_58af1a75-4acc-0506-e053-2991aa0a738f 67046-947 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071136 Contract Pharmacy Services-PA DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-950_e8e1b3d7-0272-4278-b2a3-1d10dbeb0a5a 67046-950 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20030201 UNAPPROVED DRUG OTHER Contract Pharmacy Services-PA PHENOBARBITAL 32.4 mg/1 CIV E 20171231 67046-953_e8e1b3d7-0272-4278-b2a3-1d10dbeb0a5a 67046-953 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20011201 UNAPPROVED DRUG OTHER Contract Pharmacy Services-PA PHENOBARBITAL 64.8 mg/1 CIV E 20171231 67046-959_58ada269-01fe-536f-e053-2a91aa0ab5af 67046-959 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Contract Pharmacy Services-PA ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-960_366500a0-6e91-4aaf-802a-8966b1c5a3e5 67046-960 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20110325 ANDA ANDA074112 Contract Pharmacy Services-PA ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-961_366500a0-6e91-4aaf-802a-8966b1c5a3e5 67046-961 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20110325 ANDA ANDA074112 Contract Pharmacy Services-PA ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-962_366500a0-6e91-4aaf-802a-8966b1c5a3e5 67046-962 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20110325 ANDA ANDA074112 Contract Pharmacy Services-PA ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-963_c4520457-0b0e-493f-805c-c04a788268ee 67046-963 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Contract Pharmacy Services-PA ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-964_c4520457-0b0e-493f-805c-c04a788268ee 67046-964 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Contract Pharmacy Services-PA ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-965_c4520457-0b0e-493f-805c-c04a788268ee 67046-965 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 19811016 NDA AUTHORIZED GENERIC NDA018276 Contract Pharmacy Services-PA ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-969_58ada269-01fe-536f-e053-2a91aa0ab5af 67046-969 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Contract Pharmacy Services-PA ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-970_58ada269-01fe-536f-e053-2a91aa0ab5af 67046-970 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Contract Pharmacy Services-PA ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67046-980_0209bb1e-b8fa-4fa9-a533-4dda028bd369 67046-980 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110329 ANDA ANDA071403 Contract Pharmacy Services-PA LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-981_0209bb1e-b8fa-4fa9-a533-4dda028bd369 67046-981 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110329 ANDA ANDA071404 Contract Pharmacy Services-PA LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-982_0209bb1e-b8fa-4fa9-a533-4dda028bd369 67046-982 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20110329 ANDA ANDA071141 Contract Pharmacy Services-PA LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67046-990_593b95a7-b717-cdf4-e053-2a91aa0a35ee 67046-990 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 Contract Pharmacy Services-PA BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 67046-991_593b95a7-b717-cdf4-e053-2a91aa0a35ee 67046-991 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20100924 ANDA ANDA090622 Contract Pharmacy Services-PA BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 67046-992_58ada269-01fc-536f-e053-2a91aa0ab5af 67046-992 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine Hydrochloride TABLET SUBLINGUAL 20150410 ANDA ANDA090819 Contract Pharmacy Services-PA BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 67046-993_58ada269-01fc-536f-e053-2a91aa0ab5af 67046-993 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine Hydrochloride TABLET SUBLINGUAL 20150410 ANDA ANDA090819 Contract Pharmacy Services-PA BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 67046-994_593aa0cf-bbce-14b5-e053-2a91aa0a13e5 67046-994 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine TABLET SUBLINGUAL 20100525 ANDA ANDA090360 Contract Pharmacy Services-PA BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 67046-995_593aa0cf-bbce-14b5-e053-2a91aa0a13e5 67046-995 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine TABLET SUBLINGUAL 20100525 ANDA ANDA090360 Contract Pharmacy Services-PA BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 67046-996_593c2a50-de50-6bf8-e053-2a91aa0ae306 67046-996 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Sublingual buprenorphine hydrochloride sublingual TABLET SUBLINGUAL 20150306 ANDA ANDA201066 Contract Pharmacy Services-PA BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 67046-997_593c2a50-de50-6bf8-e053-2a91aa0ae306 67046-997 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Sublingual buprenorphine hydrochloride sublingual TABLET SUBLINGUAL 20150306 ANDA ANDA201066 Contract Pharmacy Services-PA BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 67046-998_593c9ffe-e96e-d873-e053-2a91aa0a0e19 67046-998 HUMAN PRESCRIPTION DRUG Buprenorphine HCl Buprenorphine HCl TABLET SUBLINGUAL 20091008 ANDA ANDA078633 Contract Pharmacy Services-PA BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 67046-999_593c9ffe-e96e-d873-e053-2a91aa0a0e19 67046-999 HUMAN PRESCRIPTION DRUG Buprenorphine HCl Buprenorphine HCl TABLET SUBLINGUAL 20091008 ANDA ANDA078633 Contract Pharmacy Services-PA BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 67060-000_9e1ecaa5-f25b-497f-a68a-99432beacc7c 67060-000 HUMAN OTC DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET ORAL 20150409 ANDA ANDA090545 ADVANCED FIRST AID, INC. NAPROXEN SODIUM 200 1/1 N 20181231 67060-106_0636cfda-4705-4772-9eb8-d831a6d3046d 67060-106 HUMAN OTC DRUG COLD TABS II ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL TABLET ORAL 20150410 OTC MONOGRAPH FINAL part341 ADVANCED FIRST AID, INC. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 1/1; 1/1; 1/1 N 20181231 67060-140_563cc563-50be-40ab-9673-8ec30350ff3c 67060-140 HUMAN OTC DRUG PAIN AND SINUS RELIEVER ACETAMINOPHEN AND PHENYLEPHRINE TABLET ORAL 20150409 OTC MONOGRAPH FINAL part341 ADVANCED FIRST AID, INC. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 1/1; 1/1 N 20181231 67060-210_5538d433-d49f-4772-8701-20af76f7f5f8 67060-210 HUMAN OTC DRUG NON-ASPIRIN ACETAMINOPHEN TABLET ORAL 20150410 OTC MONOGRAPH NOT FINAL part343 ADVANCED FIRST AID, INC. ACETAMINOPHEN 500 1/1 N 20181231 67060-232_627cbe02-0c2e-41ef-a26f-6fb7dce0c13f 67060-232 HUMAN OTC DRUG ADVANCED ASPIRIN ASPIRIN TABLET ORAL 20150407 OTC MONOGRAPH NOT FINAL part343 ADVANCED FIRST AID, INC. ASPIRIN 325 1/1 N 20181231 67060-242_1a28139f-a4fd-4bb7-8cab-95af9b280f8c 67060-242 HUMAN OTC DRUG PAIN RELIEVER ACETAMINOPHEN, ASPIRIN, SALICYLAMIDE TABLET ORAL 20150407 OTC MONOGRAPH NOT FINAL part343 ADVANCED FIRST AID, INC. ACETAMINOPHEN; ASPIRIN; SALICYLAMIDE 110; 162; 152 1/1; 1/1; 1/1 N 20181231 67060-303_542ccac5-cd5f-4d67-9bf0-7394aaf207f3 67060-303 HUMAN OTC DRUG MINT ANTACID CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20150407 OTC MONOGRAPH FINAL part331 ADVANCED FIRST AID, INC. CALCIUM CARBONATE 420 1/1 N 20181231 67060-304_63d0332d-e6c4-4ac8-9f02-94e656c19eb8 67060-304 HUMAN OTC DRUG CHERRY ANTACID CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20150407 OTC MONOGRAPH FINAL part331 ADVANCED FIRST AID, INC. CALCIUM CARBONATE 420 1/1 N 20181231 67060-333_d4804312-b951-4590-a884-024f4f0e6bfc 67060-333 HUMAN OTC DRUG DECONGESTANT II PHENYLEPHRINE HCL TABLET ORAL 20150409 OTC MONOGRAPH FINAL part341 ADVANCED FIRST AID, INC. PHENYLEPHRINE HYDROCHLORIDE 5 1/1 N 20181231 67060-360_aaec3f90-bbce-450c-be99-113156a9218a 67060-360 HUMAN OTC DRUG Triple Antibiotic Bacitracin, Neomycin, Polymyxin B OINTMENT TOPICAL 20150408 OTC MONOGRAPH FINAL part333B ADVANCED FIRST AID, INC. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 67060-370_6fb73a20-644f-4854-ae3f-df22ebf74111 67060-370 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20150408 OTC MONOGRAPH NOT FINAL part348 ADVANCED FIRST AID, INC. HYDROCORTISONE 10 mg/g N 20181231 67060-375_6ae6bd9d-2a6e-4bc9-a0f7-bee20e2db918 67060-375 HUMAN OTC DRUG Advaced First Aid A and D WHITE PETROLATUM OINTMENT TOPICAL 20150407 OTC MONOGRAPH FINAL part347 ADVANCED FIRST AID, INC. PETROLATUM 937.5 mg/g N 20181231 67060-400_c1cda234-86c1-4181-8842-ed40cbbb3d39 67060-400 HUMAN OTC DRUG Advanced First Aid Bacitracin Bacitracin Zinc OINTMENT TOPICAL 20161018 OTC MONOGRAPH FINAL part333B ADVANCED FIRST AID, INC. BACITRACIN ZINC 500 1/g N 20181231 67060-560_f58427ee-2274-48d1-9b65-851fc9c69b20 67060-560 HUMAN OTC DRUG ADVANCED PAIN RELIEVER ACETAMINOPHEN, ASPIRIN TABLET ORAL 20150407 OTC MONOGRAPH NOT FINAL part343 ADVANCED FIRST AID, INC. ACETAMINOPHEN; ASPIRIN 250; 250 1/1; 1/1 N 20181231 67060-700_158f7716-2b9a-42f1-be9a-d9652258301f 67060-700 HUMAN OTC DRUG Cramp Tabs ACETAMINOPHEN, Pamabrom TABLET ORAL 20150810 OTC MONOGRAPH NOT FINAL part343 ADVANCED FIRST AID, INC. ACETAMINOPHEN; PAMABROM 325; 25 1/1; 1/1 N 20181231 67060-750_42018d53-98f4-4586-9ca7-60bb3886e028 67060-750 HUMAN OTC DRUG IBUPROFEN IBUPROFEN 200MG TABLET, FILM COATED ORAL 20150409 ANDA ANDA079129 ADVANCED FIRST AID, INC. IBUPROFEN 200 1/1 N 20181231 67066-005_54af55cd-de29-20f0-e054-00144ff88e88 67066-005 HUMAN PRESCRIPTION DRUG ChiRhoStim Human Secretin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20040801 NDA NDA021256 ChiRhoClin, Inc. SECRETIN HUMAN 16 ug/8mL N 20181231 67066-007_54af55cd-de29-20f0-e054-00144ff88e88 67066-007 HUMAN PRESCRIPTION DRUG ChiRhoStim 40 Human Secretin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20070601 NDA NDA021256 ChiRhoClin, Inc. SECRETIN HUMAN 40 ug/10mL N 20181231 67091-100_050578ba-0ee1-46f2-a1c8-83921e3ee0c0 67091-100 HUMAN OTC DRUG 70% Isopropyl Rubbing Alcohol Isopropyl Rubbing Alcohol SOLUTION TOPICAL 20150828 OTC MONOGRAPH NOT FINAL part333A WinCo Foods, LLC ISOPROPYL ALCOHOL .7 mg/mL N 20181231 67091-101_3b7653fd-2a79-4956-a3ce-37c16af502db 67091-101 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 19890715 OTC MONOGRAPH NOT FINAL part333A WinCo Foods, LLC HYDROGEN PEROXIDE 30 mg/mL N 20181231 67091-102_c892deaf-5511-4172-9284-5af389a649e8 67091-102 HUMAN OTC DRUG Antiseptic Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20141003 OTC MONOGRAPH NOT FINAL part356 WinCo Foods, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67091-103_deb8a5f1-626f-4d88-a369-3c14c742a8e6 67091-103 HUMAN OTC DRUG Antispetic Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20140819 OTC MONOGRAPH NOT FINAL part356 WinCo Foods, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67091-104_5c4fe6ce-245a-4e32-ad8e-a8d3f7d35a9d 67091-104 HUMAN OTC DRUG Kids Flouride Rinse Sodium Fluoride RINSE ORAL 20110209 OTC MONOGRAPH FINAL part355 WinCo Foods, LLC SODIUM FLUORIDE .2 mg/mL N 20191231 67091-105_24266b86-24a6-4cd2-a6c3-96160b84aeed 67091-105 HUMAN OTC DRUG Mint Alcohol Free Cetylpyridinium Chloride MOUTHWASH ORAL 20140926 OTC MONOGRAPH NOT FINAL part356 WinCo Foods LLC CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 67091-106_7cbf824e-f35c-4055-887c-99cb21a06c8c 67091-106 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 20141003 OTC MONOGRAPH NOT FINAL part356 WinCo Foods, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67091-107_86bc52cb-50c5-4d13-9632-3d48a5c9ab95 67091-107 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A WinCo Foods, LLC ALCOHOL 70 mL/100mL N 20181231 67091-108_0fd9d44a-b329-43d3-a6b7-2d6c1bbbaa79 67091-108 HUMAN OTC DRUG WinCo Foods Effervescent Antacid and Pain Relief ASPIRIN, SODIUM BICARBONATE, CITRIC ACID Tablet TABLET, EFFERVESCENT ORAL 20150101 OTC MONOGRAPH FINAL part343 WinCo Foods, LLC SODIUM BICARBONATE; ANHYDROUS CITRIC ACID; ASPIRIN 1916; 1000; 325 mg/1; mg/1; mg/1 N 20181231 67091-109_615efcf9-2ba7-c48f-e053-2a91aa0a6437 67091-109 HUMAN OTC DRUG WinCo Foods Effervescent Cold Relief Aspirin, Chlorpheniramine Maleate, and Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20140702 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 N 20181231 67091-110_4b7d5537-bf39-4ab4-bc60-fc1148d8866b 67091-110 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ASPIRIN 325 mg/1 N 20181231 67091-112_449d4d75-2c11-472a-b405-1559eb49e882 67091-112 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 67091-113_010b342f-a929-4d62-90ae-493ebf8b3b4d 67091-113 HUMAN OTC DRUG Acetaminophen Junior Acetaminophen TABLET, CHEWABLE ORAL 20050128 20190213 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN 160 mg/1 N 20191231 67091-114_ca417ac5-d318-46be-85bf-5be4f18eb296 67091-114 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20141231 OTC MONOGRAPH FINAL part338 WinCo Foods, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 67091-115_1e12601f-de4e-44ee-851e-64bb0ebcad64 67091-115 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET ORAL 20000610 OTC MONOGRAPH FINAL part338 WinCo Foods, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 67091-116_34b55055-bb39-4a02-949d-8b11745481bf 67091-116 HUMAN OTC DRUG Sleep Aid Maximum Strength Nighttime Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20141231 OTC MONOGRAPH FINAL part338 WinCo Foods, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 67091-117_f4d43a25-f050-4bf7-aaaa-c49b26d98586 67091-117 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 WinCo Foods, LLC CAFFEINE 200 mg/1 N 20181231 67091-118_2d584980-4958-4c19-9e66-fc4cd1dddc0a 67091-118 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 WinCo Foods, LLC DIMENHYDRINATE 50 mg/1 N 20191231 67091-119_2c0a6f23-44c9-4591-8f49-770675665b24 67091-119 HUMAN OTC DRUG Childrens Pain Relief Dye-Free Acteaminophen SUSPENSION ORAL 20141212 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 67091-120_0d1ac3ab-f454-4d2a-840a-1416056a7545 67091-120 HUMAN OTC DRUG Childrens Pain Relief Dye-Free Acteaminophen SUSPENSION ORAL 20141212 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 67091-121_5beb16ed-aa93-4f93-9538-c0a071eb6346 67091-121 HUMAN OTC DRUG Infants Pain Relief Dye-Free Acteaminophen SUSPENSION ORAL 20141212 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 67091-122_0e5dbe36-4d2e-39c3-e054-00144ff88e88 67091-122 HUMAN OTC DRUG Aspirin Chewable Low Dose ASPIRIN TABLET, CHEWABLE ORAL 20141215 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ASPIRIN 81 mg/1 N 20181231 67091-123_0e5dbe36-4c9e-39c3-e054-00144ff88e88 67091-123 HUMAN OTC DRUG Aspirin Low Dose ASPIRIN TABLET, DELAYED RELEASE ORAL 20141215 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ASPIRIN 81 mg/1 N 20181231 67091-124_0e5df7fb-718d-4df6-e054-00144ff8d46c 67091-124 HUMAN OTC DRUG Aspirin Safety Coated Adult Low Dose ASPIRIN TABLET, DELAYED RELEASE ORAL 20141215 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ASPIRIN 81 mg/1 N 20181231 67091-125_0e5dbe36-4cf1-39c3-e054-00144ff88e88 67091-125 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20141215 ANDA ANDA079129 WinCo Foods, LLC IBUPROFEN 200 mg/1 N 20181231 67091-126_0e5dbe36-4cb3-39c3-e054-00144ff88e88 67091-126 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20141215 ANDA ANDA079129 WinCo Foods, LLC IBUPROFEN 200 mg/1 N 20181231 67091-129_0e5dbe36-4cc8-39c3-e054-00144ff88e88 67091-129 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20141215 ANDA ANDA091355 WinCo Foods, LLC IBUPROFEN 200 mg/1 N 20181231 67091-130_0e5dbe36-4d43-39c3-e054-00144ff88e88 67091-130 HUMAN OTC DRUG Ibuprofen IB Ibuprofen TABLET, COATED ORAL 20141215 ANDA ANDA091355 WinCo Foods, LLC IBUPROFEN 200 mg/1 N 20181231 67091-132_0e5dbe36-4d1a-39c3-e054-00144ff88e88 67091-132 HUMAN OTC DRUG Acetaminophen Regular Strength Acetaminophen TABLET ORAL 20141215 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN 325 mg/1 N 20181231 67091-133_0e5dbe36-4d06-39c3-e054-00144ff88e88 67091-133 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET, COATED ORAL 20141215 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN 500 mg/1 N 20181231 67091-135_0e5dbe36-4cdd-39c3-e054-00144ff88e88 67091-135 HUMAN OTC DRUG Acetaminophen Easy Tabs Extra Strength Acetaminophen TABLET, COATED ORAL 20141215 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN 500 mg/1 N 20181231 67091-136_0e5dbe36-4d58-39c3-e054-00144ff88e88 67091-136 HUMAN OTC DRUG Acetaminophen Rapid Release Extra Strength Acetaminophen TABLET, COATED ORAL 20141215 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN 500 mg/1 N 20181231 67091-137_0e5dbe36-4c89-39c3-e054-00144ff88e88 67091-137 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride TABLET, COATED ORAL 20141215 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 67091-138_0e5df7fb-7178-4df6-e054-00144ff8d46c 67091-138 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20141215 ANDA ANDA079096 WinCo Foods, LLC NAPROXEN SODIUM 220 mg/1 N 20181231 67091-140_0e5dbe36-4c74-39c3-e054-00144ff88e88 67091-140 HUMAN OTC DRUG Naproxen Sodium NAPROXEN SODIUM TABLET, COATED ORAL 20141215 ANDA ANDA079096 WinCo Foods, LLC NAPROXEN SODIUM 220 mg/1 N 20181231 67091-141_485bbbec-9771-4ebf-b228-7df305bd3387 67091-141 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20141231 ANDA ANDA078682 WinCo Foods, LLC IBUPROFEN 200 mg/1 N 20181231 67091-142_26195b21-ebb7-6a11-e054-00144ff8d46c 67091-142 HUMAN OTC DRUG WinCo Foods Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20141126 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 67091-143_26195b21-eba9-6a11-e054-00144ff8d46c 67091-143 HUMAN OTC DRUG WinCo Foods Nighttime Severe Cold and Cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20141126 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 67091-145_b5c2c37d-9fbf-422f-9451-dac4bd02e917 67091-145 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20141108 OTC MONOGRAPH FINAL part347 WinCo Foods, LLC, PETROLATUM 1 g/g N 20181231 67091-146_917a96ae-e845-4305-baba-8d2544111d3b 67091-146 HUMAN OTC DRUG Witch Hazel Witch hazel LIQUID TOPICAL 20160831 OTC MONOGRAPH FINAL part347 WinCo Foods, LLC WITCH HAZEL 842 mg/mL N 20181231 67091-147_b8695c70-dd42-470e-ace6-daeef39508c6 67091-147 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20141120 OTC MONOGRAPH FINAL part346 WinCo Foods, LLC WITCH HAZEL 979 mg/mL N 20181231 67091-153_d687b0e0-439e-4bfe-afc4-2be50fd99b41 67091-153 HUMAN OTC DRUG Hand wash Benzalkonium chloride SOAP TOPICAL 20141212 OTC MONOGRAPH NOT FINAL part333A WinCo Foods, LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 67091-160_cef5b6a6-3898-4f8d-8419-8ca5231bff77 67091-160 HUMAN OTC DRUG Therapeutic Anti-Dandruff Coal Tar SHAMPOO TOPICAL 20141117 OTC MONOGRAPH FINAL part358H Winco Foods, LLC COAL TAR 25 mg/mL N 20181231 67091-161_9b58c43d-0373-4204-a24d-f3edc9c9acac 67091-161 HUMAN OTC DRUG Chest Rub Camphor, Eucalyptus Oil, Menthol JELLY TOPICAL 20141209 OTC MONOGRAPH FINAL part341 Winco Foods, LLC CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/100kg; kg/100kg; kg/100kg N 20181231 67091-168_21eee176-1a59-4b62-b4ce-07bb435b656b 67091-168 HUMAN OTC DRUG Medicated Apricot Scrub Salicylic acid GEL TOPICAL 20150113 OTC MONOGRAPH FINAL part333D WNCO FOODS LLC SALICYLIC ACID 19.8 mg/g N 20181231 67091-169_e69c0124-788b-4465-871c-3603469a5350 67091-169 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20150521 OTC MONOGRAPH NOT FINAL part334 Winco Foods, LLC MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 67091-175_d4ed194f-bab5-44ff-9f96-81b8c53a213f 67091-175 HUMAN OTC DRUG Oil Free Acne Wash Salicylic Acid 2% LOTION TOPICAL 20141120 OTC MONOGRAPH FINAL part333D Winco Foods, LLC SALICYLIC ACID 20.6 mg/mL N 20181231 67091-176_cca634e3-4608-4b7c-83f2-967c391e7b54 67091-176 HUMAN OTC DRUG Everyday Clean 2 in 1 Pyrithione Zinc SHAMPOO TOPICAL 20141209 OTC MONOGRAPH FINAL part358H WinCo Foods, LLC PYRITHIONE ZINC 10 mg/mL N 20181231 67091-178_b62542a6-d8c5-4ea0-8a2b-9710133481be 67091-178 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20141209 OTC MONOGRAPH FINAL part358H WinCo Foods, LLC PYRITHIONE ZINC 10 mg/mL N 20181231 67091-179_b91e9e52-b70f-4ad8-981f-80489c9c25b3 67091-179 HUMAN OTC DRUG Dry Scalp Pyrithione Zinc SHAMPOO TOPICAL 20141209 OTC MONOGRAPH FINAL part358H WinCo Foods, LLC PYRITHIONE ZINC 10 mg/mL N 20181231 67091-180_7d698427-dafa-4598-922d-b9a201c2ec1e 67091-180 HUMAN OTC DRUG WinCo Foods Hypoallergenic Benzalkonium chloride CLOTH TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part333A WinCo Foods, LLC BENZALKONIUM CHLORIDE .115 g/1 N 20181231 67091-191_0a8565e8-aee9-4fcd-b2db-31f360a8374b 67091-191 HUMAN OTC DRUG WinCo Foods Extra Moisturizing Nasal Relief Oxymetazoline HCL SPRAY NASAL 20141126 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC OXYMETAZOLINE HYDROCHLORIDE .005 g/100mL N 20181231 67091-192_e4ea4184-3a63-42ed-b454-d4ad2724ff4c 67091-192 HUMAN OTC DRUG WinCo Foods Severe Congestion Nasal Relief Oxymetazoline HCL SPRAY NASAL 20141201 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 67091-193_70dd3aef-3b10-4c0b-a720-a28fadcf299e 67091-193 HUMAN OTC DRUG WinCo Foods Original Nasal Oxymetazoline HCL SPRAY NASAL 20141126 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 67091-194_c388fdf8-b62e-4be8-81b1-6ffd4f58958c 67091-194 HUMAN OTC DRUG WinCo Foods Saline Nasal Sodium Chloride SPRAY NASAL 20141126 OTC MONOGRAPH FINAL part349 WinCo Foods, LLC SODIUM CHLORIDE .65 g/100mL N 20181231 67091-195_2a97b2e5-71d9-4c57-9037-698c8accbad7 67091-195 HUMAN OTC DRUG WinCo Foods Maximum Strength Acne Treatment Benzoyl peroxide CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part333D WinCo Foods, LLC BENZOYL PEROXIDE 10 g/100g N 20181231 67091-198_4b96a271-f119-4cd9-9186-947e2e0fa3d0 67091-198 HUMAN OTC DRUG WinCo Foods Maximum Strength Oral Analgesic Benzocaine GEL TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part356 WinCo Foods, LLC BENZOCAINE 200 mg/g N 20181231 67091-199_3814f283-ee8f-4ac5-ac04-e366d3edf551 67091-199 HUMAN OTC DRUG Allergy and Sinus Headache Relief Complete Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET ORAL 20050615 20200907 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/1; mg/1; mg/1 N 20181231 67091-200_62f283b7-2beb-4fb9-b594-6926f65c525e 67091-200 HUMAN OTC DRUG Allergy Relief Complete Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 67091-201_101e8619-14fb-43b2-ab47-3ae961b5d5da 67091-201 HUMAN OTC DRUG Allergy Relief Complete Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 67091-203_0cbc7f79-2dd3-4660-913f-7b739ba05082 67091-203 HUMAN OTC DRUG Allergy Relief 4 Hour Chlorpheniramine maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC CHLORPHENIRAMINE MALEATE 4 mg/1 N 20191231 67091-204_f88a26fc-62a9-4daa-b8bb-a66c738b87e8 67091-204 HUMAN OTC DRUG Cold and Flu Relief Multi symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate KIT ORAL 20141231 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC N 20181231 67091-205_ce0c1954-e4f6-420e-a270-193c96563cb4 67091-205 HUMAN OTC DRUG Cold and Flu Relief Multi symptom ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20141231 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 67091-206_2aa1c5b3-fca4-4229-811f-c41c5ac53a9f 67091-206 HUMAN OTC DRUG Cold and Flu Relief Multi Symptom Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20141231 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 67091-207_5ed24bc3-01da-4ae7-89f8-9c565af61818 67091-207 HUMAN OTC DRUG Nasal Decongestant PE Maximum Strength Phenylephrine HCl TABLET ORAL 20050114 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 67091-209_61783d7d-4bfc-4905-8c18-9812fb208227 67091-209 HUMAN OTC DRUG Nasal Decongestant PE and Pain Relief Maximum Strength Acetaminophen, Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 67091-210_61ed7b31-fc72-4dc6-87b3-efbcd789c03e 67091-210 HUMAN OTC DRUG Allergy and Pain Relief Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20050628 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 67091-211_d729b47c-28f8-4a75-8e9a-e8c966ee6dc0 67091-211 HUMAN OTC DRUG Cold and Flu Relief Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET ORAL 20050804 20190126 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 67091-212_68359c6f-04fe-48ca-96c8-12f17941ae27 67091-212 HUMAN OTC DRUG Cold and Head Congestion Relief Severe Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET ORAL 20050806 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 67091-213_85ccbe6a-398c-4160-8440-19af7fcb99c6 67091-213 HUMAN OTC DRUG Sinus Congestion and Pain Relief Non-Drowsy Acetaminophen, Phenylephrine HCl TABLET ORAL 20050726 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 67091-214_b61fd71c-06e9-4926-a0d0-45498e646477 67091-214 HUMAN OTC DRUG Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20141231 OTC MONOGRAPH NOT FINAL part334 WinCo Foods, LLC DOCUSATE SODIUM 100 mg/1 N 20181231 67091-215_795c1af2-2074-4b1b-ae68-fb562af1afa5 67091-215 HUMAN OTC DRUG Laxative Gentle Bisacodyl TABLET, SUGAR COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 WinCo Foods, LLC BISACODYL 5 mg/1 N 20191231 67091-216_4e5c7637-4680-4355-86d5-39248d7e9cbf 67091-216 HUMAN OTC DRUG Laxative Womens Bisacodyl TABLET ORAL 20000901 20181214 OTC MONOGRAPH NOT FINAL part334 WinCo Foods, LLC BISACODYL 5 mg/1 E 20171231 67091-217_6bd8c509-9638-4fda-a897-f9bd5d2511be 67091-217 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET ORAL 20030102 OTC MONOGRAPH NOT FINAL part334 WinCo Foods, LLC SENNOSIDES 25 mg/1 N 20181231 67091-218_994d9096-a622-493d-b128-9509d0629dc9 67091-218 HUMAN OTC DRUG Infants Gas Relief Drops simethicone EMULSION ORAL 20141124 OTC MONOGRAPH FINAL part332 WinCo Foods, LLC DIMETHICONE 20 mg/.3mL N 20181231 67091-219_1221d072-35cc-4aae-b5fe-e6591b881077 67091-219 HUMAN OTC DRUG Childrens Allergy Relief Dye Free Cherry Diphenhydramine HCl LIQUID ORAL 20141212 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 67091-220_0cf27702-8bc4-4713-9700-61cb386e2931 67091-220 HUMAN OTC DRUG Childrens Multi-symptom Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141212 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 67091-221_b3474b52-7894-4762-a4f8-b11160f4adc6 67091-221 HUMAN OTC DRUG Childrens Multi-Symptom Cold and Fever Relief Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141212 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN 325; 10; 5; 200 mg/10mL; mg/10mL; mg/10mL; mg/10mL N 20181231 67091-222_59c09459-35e7-4a29-905d-e38df277ee8d 67091-222 HUMAN OTC DRUG Fiber Psyllium Husk CAPSULE ORAL 20141212 OTC MONOGRAPH NOT FINAL part334 WinCo Foods, LLC PSYLLIUM HUSK .52 g/1 N 20181231 67091-224_8203a070-053f-458f-b5a2-68467da607de 67091-224 HUMAN OTC DRUG Antacid calcium carbonate TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part331 WinCo Foods, LLC CALCIUM CARBONATE 500 mg/1 N 20181231 67091-225_1f83fc6e-b40d-4b68-a159-3d1731a260cc 67091-225 HUMAN OTC DRUG Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part331 WinCo Foods, LLC CALCIUM CARBONATE 500 mg/1 N 20181231 67091-226_6b20d593-562b-48c8-96f7-4974ccfa43a2 67091-226 HUMAN OTC DRUG Antacid Ultra Strength Assorted Berries Calcium carbonate TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part331 WinCo Foods, LLC CALCIUM CARBONATE 1000 mg/1 N 20181231 67091-227_66d928cf-89c7-40f2-aca2-f6fa34da0e55 67091-227 HUMAN OTC DRUG Antacid Extra Strength Assorted Berries Calcium carbonate TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part331 WinCo Foods, LLC CALCIUM CARBONATE 750 mg/1 N 20181231 67091-228_28c197e4-24ab-4278-8457-56ce75aafebf 67091-228 HUMAN OTC DRUG Antacid Extra Strength Assorted Fruit Calcium antacid TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part331 WinCo Foods, LLC CALCIUM CARBONATE 750 mg/1 N 20181231 67091-229_9ef5ee3a-feb8-42fb-80e6-9a46d89291af 67091-229 HUMAN OTC DRUG Antacid Extra Strength Assorted Fruit Calcium antacid TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part331 WinCo Foods, LLC CALCIUM CARBONATE 750 mg/1 N 20181231 67091-231_7195a2f4-e4a0-42fa-873f-e42781953356 67091-231 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20140930 OTC MONOGRAPH FINAL part347 WinCo Foods, LLC DIMETHICONE 125 mg/1 N 20181231 67091-232_0902418a-788d-4335-9d91-ecbccbae8710 67091-232 HUMAN OTC DRUG Gas Relief Extra Strength Cherry simethicone TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part332 WinCo Foods, LLC DIMETHICONE 125 mg/1 N 20181231 67091-233_79312415-f737-4482-9344-acd747f4e126 67091-233 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate LIQUID ORAL 20141212 OTC MONOGRAPH FINAL part335 WinCo Foods, LLC BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 67091-234_61b94eed-aada-4453-8659-4d9f57705d0b 67091-234 HUMAN OTC DRUG Maximum strength Stomach Relief Bismuth Subsalicylate LIQUID ORAL 20141212 OTC MONOGRAPH FINAL part335 WinCo Foods, LLC BISMUTH SUBSALICYLATE 525 mg/15mL N 20181231 67091-235_ceb15e78-59ec-4b59-b5e8-7703524562cd 67091-235 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20141212 OTC MONOGRAPH FINAL part335 WinCo Foods, LLC BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 67091-238_faabe6b9-a077-46b9-85aa-abb7db91a7c5 67091-238 HUMAN OTC DRUG WinCo Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20150115 UNAPPROVED DRUG OTHER WinCo Foods, LLC PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 67091-239_d5251391-32d1-4c0f-9cd4-b0b9bb0e71b0 67091-239 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 WinCo Foods, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 67091-240_d5251391-32d1-4c0f-9cd4-b0b9bb0e71b0 67091-240 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride TABLET ORAL 19930201 ANDA ANDA074091 WinCo Foods, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 67091-241_d622b654-bd85-4da9-aeaa-3c6a362e5b0b 67091-241 HUMAN OTC DRUG Famotidine - Acid Controller Famotidine TABLET, FILM COATED ORAL 20120501 ANDA ANDA090283 WinCo Foods, LLC FAMOTIDINE 20 mg/1 N 20181231 67091-242_d622b654-bd85-4da9-aeaa-3c6a362e5b0b 67091-242 HUMAN OTC DRUG Famotidine - Acid Controller Famotidine TABLET, FILM COATED ORAL 20120501 ANDA ANDA090283 WinCo Foods, LLC FAMOTIDINE 10 mg/1 N 20181231 67091-243_6fb74c00-4901-4cd0-87d7-7c14b4fb14e1 67091-243 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20120815 ANDA ANDA200536 WinCo Foods, LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 67091-244_70bc7062-ab3c-43eb-b524-0d8c6d1a674d 67091-244 HUMAN OTC DRUG Acid Reducer Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120802 ANDA ANDA201745 WinCo Foods, LLC RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 67091-245_506a60e8-7fec-4bb0-babc-204058ae120f 67091-245 HUMAN OTC DRUG Loratadine Allergy Relief Loratadine TABLET ORAL 20030828 ANDA ANDA076134 WinCo Foods, LLC LORATADINE 10 mg/1 N 20181231 67091-246_506a60e8-7fec-4bb0-babc-204058ae120f 67091-246 HUMAN OTC DRUG Loratadine Allergy Relief Loratadine TABLET ORAL 20030828 ANDA ANDA076134 WinCo Foods, LLC LORATADINE 10 mg/1 N 20181231 67091-247_75838b78-8a5d-4f35-8be1-76d398cf1c9a 67091-247 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20120120 ANDA ANDA077498 WinCo Foods, LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 67091-249_60a9c437-0513-4196-85d9-e175bb8e4ed6 67091-249 HUMAN OTC DRUG Winco Original SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20150102 OTC MONOGRAPH NOT FINAL part352 Winco PETROLATUM; PADIMATE O 44; 1.5 mg/g; mg/g N 20181231 67091-250_6dd76e6a-42b2-4539-abfe-fa600db693ca 67091-250 HUMAN OTC DRUG Winco Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20150102 OTC MONOGRAPH NOT FINAL part352 Winco OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g N 20181231 67091-251_c81cd9f7-f23a-4873-8542-1926497d39ce 67091-251 HUMAN OTC DRUG Winco Medicated Lip Balm Petrolatum STICK TOPICAL 20150102 OTC MONOGRAPH FINAL part347 Winco PETROLATUM 30 mg/g N 20181231 67091-252_e3937472-0d9d-4f3d-aa8a-72df67e38c6b 67091-252 HUMAN OTC DRUG Winco Cherry SPF 4 Lip Balm Padimate O, Petrolatum STICK TOPICAL 20150102 OTC MONOGRAPH NOT FINAL part352 Winco PETROLATUM; PADIMATE O 44; 1.5 mg/g; mg/g N 20181231 67091-257_aaf7e070-9b4f-43a7-ba8e-d663dd28afd9 67091-257 HUMAN OTC DRUG Cold and Flu Relief Multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 67091-258_9aed37d8-b88d-4aff-8bdd-3a3fb1885f14 67091-258 HUMAN OTC DRUG Cold and Flu Relief Multi Symptom Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 67091-260_50811faf-2fbb-41b7-b9ce-517bbef94f67 67091-260 HUMAN OTC DRUG Cold and Flu Relief Multi Symptom Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 67091-264_32e329ac-a3a1-4d74-aebd-e4ea31720025 67091-264 HUMAN OTC DRUG Tussin Chest Congestion Non Drowsy Guaifenesin LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC GUAIFENESIN 200 mg/10mL N 20181231 67091-265_91fc6016-49f4-46d0-8924-1181dded1628 67091-265 HUMAN OTC DRUG Tussin DM Cough and Chest Non Drowsy Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 67091-266_7de96334-c7a4-4beb-a8c3-dad722d01409 67091-266 HUMAN OTC DRUG Tussin CF Non Drowsy Multi Symptom Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20141231 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 67091-267_3100ab0e-0ed8-41c2-b1b1-6401623a446d 67091-267 HUMAN OTC DRUG Sore Throat Relief Phenol SPRAY ORAL 20141231 OTC MONOGRAPH NOT FINAL part356 WinCo Foods, LLC PHENOL 1.4 g/100mL N 20181231 67091-268_9d68235e-260c-4a5a-bdb0-a483bb0311ed 67091-268 HUMAN OTC DRUG Body Menthol POWDER TOPICAL 20150209 OTC MONOGRAPH NOT FINAL part348 WinCo Foods, LLC MENTHOL 1.5 mg/g N 20181231 67091-272_603fa7af-653c-3d33-e053-2a91aa0a2448 67091-272 HUMAN OTC DRUG WinCo Maximum Strength Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Poymyxin B Sulfate, and Pramoxine Hydrochrloride OINTMENT TOPICAL 20150210 OTC MONOGRAPH FINAL part333B WinCo Foods, LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 1; 10000; 10 [USP'U]/g; g/g; [USP'U]/g; mg/g N 20181231 67091-273_f899e86a-3c29-4857-965e-19ec2f5e83c8 67091-273 HUMAN OTC DRUG Winco Bacitracin Bacitracin OINTMENT TOPICAL 20150209 OTC MONOGRAPH FINAL part333B WinCo Foods, LLC BACITRACIN 500 [USP'U]/g N 20181231 67091-274_6041a513-70ba-a1ac-e053-2a91aa0a6370 67091-274 HUMAN OTC DRUG WinCo Original Strength Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 20150212 OTC MONOGRAPH FINAL part333B WinCo Foods, LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 67091-275_6041f9ae-ad19-0af1-e053-2a91aa0adc4e 67091-275 HUMAN OTC DRUG WinCo Extra Strength Cold and Hot Medicated Menthol PATCH TOPICAL 20150216 OTC MONOGRAPH NOT FINAL part348 WinCo Foods, LLC MENTHOL 5 g/100g N 20181231 67091-276_29b9f1b1-55d6-4033-98aa-4936060a9b40 67091-276 HUMAN OTC DRUG Winco Foods Tolnaftate Tolnaftate CREAM TOPICAL 20150206 OTC MONOGRAPH FINAL part333C Winco Foods, LLC TOLNAFTATE 10 mg/g N 20181231 67091-277_7ead9745-14b2-4b1f-9e83-7a3379a80e6e 67091-277 HUMAN OTC DRUG WinCo Original Strength Anti-Itch Diphenhydramine hydrochloride, and Zinc acetate CREAM TOPICAL 20140209 OTC MONOGRAPH NOT FINAL part348 WinCo Foods, LLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/g; mg/g N 20181231 67091-278_eff757be-a853-4763-9a67-62e1994b028e 67091-278 HUMAN OTC DRUG Winco Hemorrhoidal Mineral oil, Petrolatum, and Phenylephrine hydrochloride CREAM TOPICAL 20150129 OTC MONOGRAPH FINAL part346 Winco Foods, LLC MINERAL OIL; PHENYLEPHRINE HYDROCHLORIDE; PETROLATUM 140; 2.5; 749 mg/g; mg/g; mg/g N 20181231 67091-279_15294434-21cb-4974-b286-d706166b6538 67091-279 HUMAN OTC DRUG WinCo Antifungal Clotrimazole CREAM TOPICAL 20150210 OTC MONOGRAPH FINAL part333C WinCo Foods, LLC CLOTRIMAZOLE 10 mg/g N 20181231 67091-280_84993049-4add-4488-838c-5cdceae4f48c 67091-280 HUMAN OTC DRUG WinCo Maximum Strength Hydrocortisone Hydrocortisone CREAM TOPICAL 20150216 OTC MONOGRAPH NOT FINAL part348 WinCo Foods, LLC HYDROCORTISONE 1 g/100g N 20181231 67091-281_994f8705-084d-48b2-a8a2-29c91be9ee12 67091-281 HUMAN OTC DRUG WinCo Maximum Strength Hydrocortisone Hydrocortisone CREAM TOPICAL 20150216 OTC MONOGRAPH NOT FINAL part348 WinCo Foods, LLC HYDROCORTISONE 1 g/100g N 20181231 67091-282_56e49eeb-720a-4c39-9182-fcb1f9ba22a9 67091-282 HUMAN OTC DRUG Advance Relief Eye Drops DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCl SOLUTION/ DROPS OPHTHALMIC 20150109 OTC MONOGRAPH FINAL part349 WinCo Foods, LLC DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 100; 1000; 1000; 50 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 67091-283_40e7cff5-e935-40c4-a52f-b3baf98684e5 67091-283 HUMAN OTC DRUG Irritation Relief Eye Tetrahydrozoline HCl, Zinc sulfate SOLUTION/ DROPS OPHTHALMIC 20150109 OTC MONOGRAPH FINAL part349 WinCo Foods, LLC TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE 50; 250 mg/100mL; mg/100mL N 20181231 67091-284_e74d7f46-eff9-46dd-816e-6a46ee84dbd3 67091-284 HUMAN OTC DRUG Artificial Tears Lubricant Eye polyvinyl alcohol, povidone SOLUTION/ DROPS OPHTHALMIC 20150109 OTC MONOGRAPH FINAL part349 WinCo Foods, LLC POLYVINYL ALCOHOL; POVIDONE 500; 600 mg/100mL; mg/100mL N 20181231 67091-285_bc3cea1c-ed19-49ab-be27-44be8c62a8f8 67091-285 HUMAN OTC DRUG Maximum Redness Relief Eye Glycerin, Naphazoline HCl SOLUTION/ DROPS OPHTHALMIC 20150109 OTC MONOGRAPH FINAL part349 WinCo Foods, LLC GLYCERIN; NAPHAZOLINE HYDROCHLORIDE 500; 30 mg/100mL; mg/100mL N 20181231 67091-286_7a141cad-8cae-4a31-a6e0-df61031999c3 67091-286 HUMAN OTC DRUG Laxative Women Bisacodyl TABLET, COATED ORAL 20150916 OTC MONOGRAPH NOT FINAL part334 WinCo Foods, LLC BISACODYL 5 mg/1 N 20181231 67091-287_36b6b15d-6d52-4a77-bf0c-954b4651a179 67091-287 HUMAN OTC DRUG Cold and Flu Relief Multi symptom Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20170228 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 67091-288_11d80268-8661-4163-a38b-a0fb99b776d6 67091-288 HUMAN OTC DRUG Cold and Flu Relief Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 67091-289_10cb96fe-661d-4356-bfb6-aaaa8185385a 67091-289 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20151216 OTC MONOGRAPH NOT FINAL part333A WinCo Foods, LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 67091-290_02c76534-61a2-4dd5-b1e7-d7187d207a0c 67091-290 HUMAN OTC DRUG Sleep Aid NightTime Diphenhydramine HCl LIQUID ORAL 20160630 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 67091-291_34a103a2-5f7c-2116-e054-00144ff8d46c 67091-291 HUMAN OTC DRUG Winco Foods Multi-Symptom Severe Cold Green Tea and Honey Lemon flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20160606 OTC MONOGRAPH FINAL part341 Winco Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 67091-292_37d19661-1615-4d1e-b5ff-b609b9aacfbf 67091-292 HUMAN OTC DRUG NightTime Cough DM Maximum Strength Dextromethorphan HBr, Doxylamine Succinate LIQUID ORAL 20160630 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/10mL; mg/10mL N 20181231 67091-293_18e94f70-f2b1-49fb-84e6-00e4d6b07f2a 67091-293 HUMAN OTC DRUG Cold, Flu and Sore Throat Relief Maximum Strength, Multi Symptom Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 67091-294_e3c980bb-2a81-45da-8735-4a9941ccaf49 67091-294 HUMAN OTC DRUG Severe Congestion and Cold Relief Maximum Strength, Multi Symptom Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20130407 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 67091-300_5b2396f2-535a-aeec-e053-2991aa0a21f3 67091-300 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20160608 OTC MONOGRAPH FINAL part341 Winco Foods MENTHOL 5.4 mg/1 N 20181231 67091-300_5b23c1b3-4f99-c116-e053-2991aa0a3c78 67091-300 HUMAN OTC DRUG menthol cough drops menthol LOZENGE ORAL 20140819 OTC MONOGRAPH FINAL part341 Winco Foods MENTHOL 5.4 mg/1 N 20181231 67091-301_5b337dfc-109c-995e-e053-2a91aa0a6dfa 67091-301 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20140819 OTC MONOGRAPH FINAL part341 Winco Foods MENTHOL 5.8 mg/1 N 20181231 67091-302_5b33f48d-9c68-4990-e053-2991aa0ab72f 67091-302 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20160608 OTC MONOGRAPH FINAL part341 Winco foods MENTHOL 7.5 mg/1 N 20181231 67091-302_5b340bde-5fd5-6ea6-e053-2991aa0a49d5 67091-302 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20140819 OTC MONOGRAPH FINAL part341 Winco Foods MENTHOL 7.5 mg/1 N 20181231 67091-303_5b34354d-aa37-6bea-e053-2a91aa0addff 67091-303 HUMAN OTC DRUG Sugar Free Menthol Cough Drops Menthol LOZENGE ORAL 20140819 OTC MONOGRAPH FINAL part341 Winco Foods MENTHOL 5.8 mg/1 N 20181231 67091-304_5b343e94-0ea8-5f82-e053-2a91aa0aa6b2 67091-304 HUMAN OTC DRUG sugar free cherry cough drops menthol LOZENGE ORAL 20140819 OTC MONOGRAPH FINAL part341 Winco Foods MENTHOL 5.8 mg/1 N 20181231 67091-305_b88a0bbf-3322-47e1-965a-ae8c0f3c1fc0 67091-305 HUMAN OTC DRUG Menstrual Complete Acetaminophen, Caffeine, Pyrilamine maleate TABLET ORAL 20160831 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 67091-306_be51ce20-7f5f-4260-8ba1-4c42e543f2db 67091-306 HUMAN OTC DRUG EasyLAX Polyethylene Glycol POWDER TOPICAL 20160831 ANDA ANDA091077 WinCo Foods, LLC POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 67091-307_b9e6111e-58ec-4f54-aedf-d04187ed21ac 67091-307 HUMAN OTC DRUG Rubbing Alcohol 91 percent isopropyl Isopropyl alcohol LIQUID TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A WinCo Foods, LLC ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 67091-308_c66a8cde-877b-48ef-939e-e9de67f367e4 67091-308 HUMAN OTC DRUG Cold and Flu Relief DayTime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI CAPSULE, LIQUID FILLED ORAL 20160930 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 67091-309_f2a130e7-11f9-4703-9435-d8a95fb319b4 67091-309 HUMAN OTC DRUG Cold and Flu Relief Multi symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine succinate KIT ORAL 20160930 OTC MONOGRAPH FINAL part341 WinCo Foods, LLC N 20181231 67091-311_bb828290-02d4-46d4-aec6-ddd618256fb8 67091-311 HUMAN OTC DRUG childrens acetaminophen Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 WinCo Foods, LLC ACETAMINOPHEN 160 mg/1 N 20181231 67091-312_53964cc6-a27d-1f1c-e054-00144ff88e88 67091-312 HUMAN OTC DRUG Herbal Cough Drop Menthol LOZENGE ORAL 20170705 OTC MONOGRAPH FINAL part341 Winco Foods LLC MENTHOL 4.8 mg/1 N 20181231 67091-320_7ffb3431-86bf-43c8-bea2-d92f037c9d46 67091-320 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20171231 OTC MONOGRAPH FINAL part347 WinCo Foods, LLC DIMETHICONE 125 mg/1 N 20191231 67091-439_69a70395-4d4c-4701-911c-96fa142fa782 67091-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20170703 OTC MONOGRAPH NOT FINAL part333A Winco Foods ALCOHOL 700 mg/mL N 20181231 67091-641_359cfe96-26ef-471d-8dbc-88a2a28f292c 67091-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20150106 OTC MONOGRAPH NOT FINAL part333A Winco Foods, LLC BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 67091-952_9f885397-12cf-4549-9624-b7d092479cd9 67091-952 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20170703 OTC MONOGRAPH NOT FINAL part333A Winco Foods BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 67108-3565_0cbac5d2-0e5b-4f12-807c-243ad5f27c86 67108-3565 HUMAN PRESCRIPTION DRUG MESNEX MESNA TABLET, FILM COATED ORAL 20020321 NDA NDA020855 Baxter Healthcare Corporation MESNA 400 mg/1 Cytoprotective Agent [EPC] N 20181231 67112-101_756552e9-c2e2-439d-ad70-48da6db7855f 67112-101 HUMAN PRESCRIPTION DRUG TRICARE PRENATAL ASCORBIC ACID, CHOLECALCIFEROL, DL-.ALPHA.-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC SULFATE TABLET, COATED ORAL 20120101 UNAPPROVED DRUG OTHER Medecor Pharma, LLC ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC SULFATE 100; 400; 30; 1.6; 1.6; 20; 3.1; 1; 12; 200; 27; 10; 2 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] E 20171231 67112-401_7fa1f4ef-0ad6-4239-b7dc-553906d0559d 67112-401 HUMAN PRESCRIPTION DRUG TRICARE PRENATAL DHA ONE FISH OIL, DOCONEXENT, ICOSAPENT, THIAMINE MONONITRATE, RIBOFLAVIN, INOSITOL NIACINATE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, ASCORBIC ACID, CHOLECALCIFEROL, D-ALPHA-TOCOPHEROL, BIOTIN, FERROUS FUMARATE, ZINC SULFATE MONOHYDRATE, CUPRIC SULFATE ANHYDROUS, DOCUSATE SODIUM CAPSULE, GELATIN COATED ORAL 20120101 UNAPPROVED DRUG OTHER Medecor Pharma, LLC FISH OIL; DOCONEXENT; ICOSAPENT; THIAMINE MONONITRATE; RIBOFLAVIN; INOSITOL NIACINATE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; FOLIC ACID; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, D-; BIOTIN; FERROUS FUMARATE; ZINC SULFATE MONOHYDRATE; CUPRIC SULFATE ANHYDROUS; DOCUSATE SODIUM 500; 215; 45; 3; 3.4; 20; 25; 100; 1; 60; 800; 30; 300; 27; 10; 2; 25 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; [iU]/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] E 20171231 67112-501_c48f3178-78ab-4dcd-b703-640456494092 67112-501 HUMAN PRESCRIPTION DRUG TRICARE PRENATAL COMPLEAT ESSENTIAL FATTY ACIDS, MULTIVITAMINS, MINERALS KIT 20130321 UNAPPROVED DRUG OTHER Medecor Pharma, LLC E 20171231 67112-502_8ab123cf-c205-4551-8fca-c9ace007abd6 67112-502 HUMAN PRESCRIPTION DRUG TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM 18 ESSENTIAL VITAMINS AND MINERALS, ULTRA PURE DHA KIT 20160510 UNAPPROVED DRUG OTHER Medecor Pharma, LLC E 20171231 67138-533_86239ca0-709d-45e4-97b1-c185dc945efb 67138-533 HUMAN OTC DRUG Polar Frost Cold Menthol GEL TOPICAL 20021111 OTC MONOGRAPH NOT FINAL part348 Mettler Electronics Corp. MENTHOL 40 mg/mL E 20171231 67143-0100_71c70eda-c2a8-4a59-9470-4db06c51280f 67143-0100 HUMAN OTC DRUG Dermasil Advanced dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL E 20171231 67143-0101_c4e2b772-dbfe-443b-99a3-7bf1dd1b16a0 67143-0101 HUMAN OTC DRUG Dermasil dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL E 20171231 67143-0102_ff7d39c0-75f6-443b-899e-4bfd3f058050 67143-0102 HUMAN OTC DRUG Dermasil Sensitive dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL E 20171231 67143-1100_ff061e46-2b45-44a7-92c8-7bf28e41efdd 67143-1100 HUMAN OTC DRUG Dermasil Advanced dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL E 20171231 67143-2100_052f3034-1f54-472e-915d-f3b2eb23cdd3 67143-2100 HUMAN OTC DRUG Dermasil Advanced dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL E 20171231 67143-2101_b3f36982-ea69-4add-a392-7beac82b7245 67143-2101 HUMAN OTC DRUG Dermasil Dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL E 20171231 67143-2101_b6eb8c3f-5c7c-443b-9a8d-a602652adfe3 67143-2101 HUMAN OTC DRUG Dermasil dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL E 20171231 67143-2102_b4a5bc77-01cb-44b0-b0ba-2c58d7645e3d 67143-2102 HUMAN OTC DRUG Dermasil Sensitive dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL E 20171231 67143-3102_29d0c5f0-fa5a-4d89-a123-63cbea6c8587 67143-3102 HUMAN OTC DRUG Dermasil Sensitive dimethicone LOTION TOPICAL 20091015 OTC MONOGRAPH FINAL part347 Rise International Group LLC DIMETHICONE .01 g/mL E 20171231 67147-221_6e737375-cf4a-4271-b222-3c350a1542f7 67147-221 HUMAN OTC DRUG Hanitizer ALCOHOL GEL TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part333E Apple Products, Inc. ALCOHOL .7 mL/mL N 20181231 67147-544_7af23148-6e30-4002-8ab1-1ea0844299d9 67147-544 HUMAN OTC DRUG Pro-Care CHLOROXYLENOL SOAP TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part333E Apple Products, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 67147-576_668fb3b4-2658-45ec-a01c-aef3caa51813 67147-576 HUMAN OTC DRUG DermaCare TRICLOSAN SOAP TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333E Apple Products, Inc. TRICLOSAN .003 mL/mL E 20171231 67147-585_b8a35dcd-dba7-46d8-91f7-79c09b97eb87 67147-585 HUMAN OTC DRUG Al CaFoam ALCOHOL LIQUID TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E Apple Products, Inc. ALCOHOL .7 mL/mL N 20181231 67147-855_be49866d-0c0b-463a-8ba3-a1c684e44588 67147-855 HUMAN OTC DRUG Al CaFoam ALCOHOL LIQUID TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part333E Apple Products, Inc. ALCOHOL .62 mL/mL E 20171231 67151-303_ca5a8530-8187-40f8-9f80-daf97623758f 67151-303 HUMAN OTC DRUG Wipes Plus Benzalkonium Chloride SWAB TOPICAL 20120111 OTC MONOGRAPH FINAL part333E Progressive Products, LLC BENZALKONIUM CHLORIDE .0062 g/1 N 20181231 67151-404_df2d617d-26bb-4702-9efd-5cf9133f3950 67151-404 HUMAN OTC DRUG Alcohol Alcohol SWAB TOPICAL 20140607 OTC MONOGRAPH NOT FINAL part356 Progressive Products, LLC ALCOHOL 1.31 g/1 E 20171231 67152-001_e9e4bdc1-36e0-41e7-892f-007bbeaebabb 67152-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20101028 UNAPPROVED MEDICAL GAS Two MP Investments, Inc. dba Respicare OXYGEN 1 L/L E 20171231 67157-101_6067a844-cff1-f636-e053-2a91aa0aac7d 67157-101 HUMAN PRESCRIPTION DRUG Ascor Ascorbic Acid INJECTION INTRAVENOUS 20180115 NDA NDA209112 McGuff Pharmaceuticals, Inc. ASCORBIC ACID 500 mg/mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20181231 67172-011_a168aa95-402e-4476-ba95-f267d4d86684 67172-011 HUMAN OTC DRUG Chloraseptic Sore Throat Liquid Center Menthol and Benzocaine LOZENGE ORAL 20100801 OTC MONOGRAPH FINAL part341 Prestige Brands Holdings, Inc. MENTHOL; BENZOCAINE 10; 6 mg/1; mg/1 N 20181231 67172-012_a168aa95-402e-4476-ba95-f267d4d86684 67172-012 HUMAN OTC DRUG Chloraseptic Sore Throat Liquid Center Menthol and Benzocaine LOZENGE ORAL 20100801 OTC MONOGRAPH FINAL part341 Prestige Brands Holdings, Inc. MENTHOL; BENZOCAINE 10; 6 mg/1; mg/1 N 20181231 67172-013_a168aa95-402e-4476-ba95-f267d4d86684 67172-013 HUMAN OTC DRUG Chloraseptic Sore Throat Liquid Center Menthol and Benzocaine LOZENGE ORAL 20100801 OTC MONOGRAPH FINAL part341 Prestige Brands Holdings, Inc. MENTHOL; BENZOCAINE 10; 6 mg/1; mg/1 N 20181231 67172-015_df027ba7-4e38-42e6-931d-c79fd2fd6d34 67172-015 HUMAN OTC DRUG Chloraseptic Total Sore Throat and Cough, Sugar Free Menthol and Benzocaine and Dextromethorphan Hydrobromide LOZENGE ORAL 20100801 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. MENTHOL; BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 10; 6; 5 mg/1; mg/1; mg/1 N 20181231 67172-016_c5c358be-2eb3-47c0-a7ec-15a7d26e9ca2 67172-016 HUMAN OTC DRUG Chloraseptic Total Sore Throat and Cough Menthol and Benzocaine and Dextromethorphan Hydrobromide LOZENGE ORAL 20100801 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. MENTHOL; BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 10; 6; 5 mg/1; mg/1; mg/1 N 20181231 67172-017_d5b7c140-32e1-463f-b05d-8cb45bbb3381 67172-017 HUMAN OTC DRUG Chloraseptic Warming Sore Throat Benzocaine LOZENGE ORAL 20120101 OTC MONOGRAPH FINAL part346 Prestige Brands Holdings, Inc. BENZOCAINE 15 mg/1 N 20181231 67172-018_d5b7c140-32e1-463f-b05d-8cb45bbb3381 67172-018 HUMAN OTC DRUG Chloraseptic Warming Sore Throat Benzocaine LOZENGE ORAL 20120901 OTC MONOGRAPH FINAL part346 Prestige Brands Holdings, Inc. BENZOCAINE 15 mg/1 N 20181231 67172-111_f98129d7-3d31-41e8-b6db-7e38447899c0 67172-111 HUMAN OTC DRUG Chloraseptic Sore Throat Cherry Phenol SPRAY ORAL 20100901 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PHENOL 3.5 mg/.7mL N 20181231 67172-112_f98129d7-3d31-41e8-b6db-7e38447899c0 67172-112 HUMAN OTC DRUG Chloraseptic Sore Throat Citrus Phenol SPRAY ORAL 20100901 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PHENOL 3.5 mg/.7mL N 20181231 67172-113_f98129d7-3d31-41e8-b6db-7e38447899c0 67172-113 HUMAN OTC DRUG Chloraseptic Sore Throat Menthol Phenol SPRAY ORAL 20100901 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PHENOL 3.5 mg/.7mL N 20181231 67172-174_6c4af544-de64-4504-ae68-31b3e4d37c6d 67172-174 HUMAN OTC DRUG Chloraseptic Sore Throat Max Liquid Center Menthol and Benzocaine LOZENGE ORAL 20100801 OTC MONOGRAPH FINAL part341 Prestige Brands Holdings, Inc. MENTHOL; BENZOCAINE 10; 15 mg/1; mg/1 N 20181231 67172-181_543d8448-9ee6-4c1b-b692-bc470c502564 67172-181 HUMAN OTC DRUG Artificial Tears Lubricant Eye Polyvinyl Alcohol and Povidone LIQUID OPHTHALMIC 20120601 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL; POVIDONES 5; 6 mg/mL; mg/mL E 20171231 67172-212_3addaa67-caf6-4670-9a70-48ca5ff0e609 67172-212 HUMAN OTC DRUG Chloraseptic Warming Sore Throat Phenol SPRAY ORAL 20120701 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PHENOL 3.5 mg/.7mL N 20181231 67172-281_52621389-fbde-4d29-bc0c-9b11c602d605 67172-281 HUMAN OTC DRUG Equate Eye Drops Tetrahyrozoline hydrochloride LIQUID OPHTHALMIC 20130211 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 67172-282_52621389-fbde-4d29-bc0c-9b11c602d605 67172-282 HUMAN OTC DRUG Equate Eye Drops Tetrahyrozoline hydrochloride LIQUID OPHTHALMIC 20130211 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 67172-292_2f20039f-8632-48e4-a99c-25f4d9d7b9ba 67172-292 HUMAN OTC DRUG Clear Eyes Cooling Itchy Eye Relief Naphazoline Hydrochloride and Glycerin and Zinc Sulfate LIQUID OPHTHALMIC 20110215 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. NAPHAZOLINE HYDROCHLORIDE; GLYCERIN; ZINC SULFATE .00012; .0025; .0025 mg/mL; mg/mL; mg/mL E 20171231 67172-361_642647a7-e678-4f43-9e45-be09abdd32d1 67172-361 HUMAN OTC DRUG Murine Ear Wax Removal Drops Carbamide peroxide LIQUID AURICULAR (OTIC) 20120601 OTC MONOGRAPH FINAL part344 Prestige Brands Holdings, Inc. CARBAMIDE PEROXIDE .065 mg/mL N 20181231 67172-393_c35cbbe6-ecca-4a42-9597-98b94630b3d1 67172-393 HUMAN OTC DRUG Clear Eyes Cooling Redness Relief Glycerin and Naphazoline Hydrochloride LIQUID OPHTHALMIC 20110215 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. NAPHAZOLINE HYDROCHLORIDE; GLYCERIN .00012; .0025 mg/mL; mg/mL E 20171231 67172-494_ab8d8203-b50f-4b47-96f4-1eaff944eb37 67172-494 HUMAN OTC DRUG Clear Eyes Maximum Redness Relief Naphazoline Hydrochloride and Glycerin LIQUID OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. NAPHAZOLINE HYDROCHLORIDE; GLYCERIN .00015; .0025 mg/mL; mL/mL N 20181231 67172-500_99689145-9b51-4962-8d73-5a554080e1a2 67172-500 HUMAN OTC DRUG Clear Eyes Pure Relief for Dry Eyes glycerin SOLUTION/ DROPS OPHTHALMIC 20151215 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. GLYCERIN 2.5 mg/mL E 20171231 67172-501_8c7987ae-dbf1-4bcb-9f6e-4abd432d6d14 67172-501 HUMAN OTC DRUG Clear Eyes Pure Relief Multisymptom Glycerin SOLUTION/ DROPS OPHTHALMIC 20151215 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. PHENYLEPHRINE HYDROCHLORIDE; GLYCERIN; HYPROMELLOSES 1; 2.5; 3 mg/mL; mg/mL; mg/mL E 20171231 67172-557_ba0dfae3-c3f8-40f6-ac3d-4c0610aff090 67172-557 HUMAN OTC DRUG Clear Eyes Natural Tears Polyvinyl alcohol and Povidone LIQUID OPHTHALMIC 20130515 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE 5; 6 mg/mL; mg/mL N 20181231 67172-574_4c67e61f-98cf-4f9f-a2d9-1a9571b8e464 67172-574 HUMAN OTC DRUG Murine Tears for Dry Eyes Polyvinyl Alcohol and Povidone LIQUID OPHTHALMIC 20121001 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL; POVIDONES .05; .06 mL/mL; mL/mL E 20171231 67172-584_0e73b974-20bf-4753-a3f3-4ad2fb5776ed 67172-584 HUMAN OTC DRUG Clear Eyes Travelers Eye Relief Polyvinyl Alcohol and Povidone and Tetrahydrozoline Hydrochloride LIQUID OPHTHALMIC 20111115 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE 5; 6; .5 mg/mL; mg/mL; mg/mL N 20181231 67172-585_0e73b974-20bf-4753-a3f3-4ad2fb5776ed 67172-585 HUMAN OTC DRUG Clear Eyes Travelers Eye Relief Polyvinyl Alcohol and Povidone and Tetrahydrozoline Hydrochloride LIQUID OPHTHALMIC 20111115 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL; POVIDONES; TETRAHYDROZOLINE HYDROCHLORIDE 5; 6; .5 mg/mL; mg/mL; mg/mL N 20181231 67172-595_183db81c-7986-4626-88a6-341db9be25ce 67172-595 HUMAN OTC DRUG Clear Eyes Complete 7 Symptom Relief Hypromellose and Naphazoline Hydrochloride and Polysorbate 80 and Zinc Sulfate LIQUID OPHTHALMIC 20100301 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. ZINC SULFATE; POLYSORBATE 80; NAPHAZOLINE HYDROCHLORIDE; HYPROMELLOSE .625; 1.25; .0625; .5 mL/mL; mL/mL; mL/mL; mL/mL N 20181231 67172-686_def2a245-07e1-4550-89e3-2777d678fe30 67172-686 HUMAN OTC DRUG Clear Eyes Outdoor Dry Eye Protection Polyvinyl Alcohol and Povidone LIQUID OPHTHALMIC 20111115 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL; POVIDONE .075; .09 mL/mL; mL/mL E 20171231 67172-696_391ac259-a840-48dd-80c0-0fab8ba1e2b1 67172-696 HUMAN OTC DRUG Clear Eyes Maximum Redness Relief Naphazoline Hydrochloride and Glycerin LIQUID OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. NAPHAZOLINE HYDROCHLORIDE; GLYCERIN .3; 5 mg/mL; mg/mL N 20181231 67172-707_00de5b39-5db6-4089-8426-579eeb733946 67172-707 HUMAN OTC DRUG Clear Eyes Complete 7 Sympton Relief Hypromellose, Naphazoline Hydrochloride, Polysorbate 80 and Zinc Sulfate LIQUID OPHTHALMIC 20130612 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. HYPROMELLOSES; NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80; ZINC SULFATE .5; .0625; 1.25; .625 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 67172-796_04b82cf2-b979-4ceb-93cf-b2a82b167c16 67172-796 HUMAN OTC DRUG Clear Eyes Redness Relief Handy Pocket Pal Naphazoline Hydrochloride and Glycerin LIQUID OPHTHALMIC 20121101 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. NAPHAZOLINE HYDROCHLORIDE; GLYCERIN .00012; .0025 mg/mL; mg/mL N 20181231 67172-797_04b82cf2-b979-4ceb-93cf-b2a82b167c16 67172-797 HUMAN OTC DRUG Clear Eyes Redness Relief Naphazoline Hydrochloride and Glycerin LIQUID OPHTHALMIC 20110427 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. NAPHAZOLINE HYDROCHLORIDE; GLYCERIN .12; 2.5 mg/mL; mg/mL N 20181231 67172-898_b36c1e74-6366-454a-92f3-a80b93374049 67172-898 HUMAN OTC DRUG Clear Eyes Triple Action Polyvinyl Alcohol and Povidone and Tetrahydrozoline Hydrochloride LIQUID OPHTHALMIC 20110315 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE 5; 6; .5 mg/mL; mg/mL; mg/mL N 20181231 67172-935_f09bdfd4-03b6-4454-b465-b4b579e03da0 67172-935 HUMAN OTC DRUG Chloraseptic Sore Throat Phenol SPRAY ORAL 20100901 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PHENOL 3.5 mg/.7mL N 20181231 67172-937_a13e7e3d-e90f-4562-8724-5a6ad8558919 67172-937 HUMAN OTC DRUG Chloraseptic Sore Throat Max Phenol and Glycerin SPRAY ORAL 20110201 OTC MONOGRAPH NOT FINAL part356 Prestige Brands Holdings, Inc. PHENOL; GLYCERIN 15; 330 mg/mL; mg/mL N 20181231 67172-999_329e0d5f-8da7-4493-8e42-5e94f5e0b11e 67172-999 HUMAN OTC DRUG Clear Eyes Maximum Itchy Eye Relief Glycerin and Naphazoline Hydrochloride and Zinc Sulfate LIQUID OPHTHALMIC 20110315 OTC MONOGRAPH FINAL part349 Prestige Brands Holdings, Inc. GLYCERIN; NAPHAZOLINE HYDROCHLORIDE; ZINC SULFATE .625; .21; .625 mL/mL; mL/mL; mL/mL E 20171231 67184-0507_16b0d44e-66e0-449a-ae5c-d9ec98c15051 67184-0507 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140908 ANDA ANDA203711 Qilu Pharmaceutical Co., Ltd. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 67184-0508_ee5a5a1d-63f6-4d5a-901b-65be45ec6610 67184-0508 HUMAN PRESCRIPTION DRUG Oxaliplatin oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20160607 ANDA ANDA204368 Qilu Pharmaceutical Co., Ltd. OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 67184-0509_ee5a5a1d-63f6-4d5a-901b-65be45ec6610 67184-0509 HUMAN PRESCRIPTION DRUG Oxaliplatin oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20160607 ANDA ANDA204368 Qilu Pharmaceutical Co., Ltd. OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 67184-0510_ee5a5a1d-63f6-4d5a-901b-65be45ec6610 67184-0510 HUMAN PRESCRIPTION DRUG Oxaliplatin oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20160607 ANDA ANDA204368 Qilu Pharmaceutical Co., Ltd. OXALIPLATIN 200 mg/40mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 67184-1001_3266ff55-1ba0-4286-90e2-dfa91e02e0ef 67184-1001 HUMAN PRESCRIPTION DRUG Cefazolin Cefazolin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151228 ANDA ANDA203661 Qilu Pharmaceutical Co., Ltd. CEFAZOLIN SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67184-1002_667c2c23-4a6e-43f8-9e8e-5688b17d0370 67184-1002 HUMAN PRESCRIPTION DRUG Cefepime CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160201 ANDA ANDA203704 Qilu Pharmaceutical Co., Ltd. CEFEPIME HYDROCHLORIDE 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67184-1003_667c2c23-4a6e-43f8-9e8e-5688b17d0370 67184-1003 HUMAN PRESCRIPTION DRUG Cefepime CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160201 ANDA ANDA203704 Qilu Pharmaceutical Co., Ltd. CEFEPIME HYDROCHLORIDE 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67184-1004_667c2c23-4a6e-43f8-9e8e-5688b17d0370 67184-1004 HUMAN PRESCRIPTION DRUG Cefepime CEFEPIME HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160201 ANDA ANDA203704 Qilu Pharmaceutical Co., Ltd. CEFEPIME HYDROCHLORIDE 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67184-1005_25d5f503-6396-4a26-b049-15e0ae09a145 67184-1005 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160629 ANDA ANDA203702 Qilu Pharmaceutical Co., Ltd. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67184-1006_25d5f503-6396-4a26-b049-15e0ae09a145 67184-1006 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160629 ANDA ANDA203702 Qilu Pharmaceutical Co., Ltd. CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67184-1007_25d5f503-6396-4a26-b049-15e0ae09a145 67184-1007 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160629 ANDA ANDA203702 Qilu Pharmaceutical Co., Ltd. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67184-1008_25d5f503-6396-4a26-b049-15e0ae09a145 67184-1008 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160629 ANDA ANDA203702 Qilu Pharmaceutical Co., Ltd. CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67191-001_244868e6-2b14-6eae-e054-00144ff88e88 67191-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130222 UNAPPROVED MEDICAL GAS Clinical Medical Services Inc. OXYGEN 99 L/100L E 20171231 67194-005_60e28167-aab8-3d6e-e053-2a91aa0a342f 67194-005 HUMAN OTC DRUG Numquick Topical Analgesic EPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20160120 OTC MONOGRAPH FINAL part346 Unit Dose, Ltd. EPINEPHRINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE .1; 50 mg/mL; mg/mL N 20181231 67194-007_60e27d7b-0b39-35fc-e053-2a91aa0a8934 67194-007 HUMAN OTC DRUG Numquick Analgesic EPINEPHRINE, LIDOCAINE HYDROCHLORIDE SOLUTION TOPICAL 20160120 OTC MONOGRAPH FINAL part346 Unit Dose, Ltd. EPINEPHRINE; LIDOCAINE HYDROCHLORIDE .1; 50 mg/mL; mg/mL N 20181231 67194-012_60e29cf2-4310-6163-e053-2a91aa0a7070 67194-012 HUMAN OTC DRUG Healquick Tattoo Balm PETROLATUM STICK TOPICAL 20160122 OTC MONOGRAPH FINAL part346 Unit Dose, Ltd. PETROLATUM 670 mg/g N 20181231 67194-013_60e29ef6-0b0a-559a-e053-2a91aa0a5cb0 67194-013 HUMAN OTC DRUG Tetragel Punch Topical Analgesic TETRACAINE GEL TOPICAL 20160120 OTC MONOGRAPH NOT FINAL part348 Unit Dose, Ltd. TETRACAINE 20 mg/g N 20181231 67194-014_29ef79dc-38b3-7226-e054-00144ff8d46c 67194-014 HUMAN OTC DRUG Numstick PETROLATUM, LIDOCAINE STICK TOPICAL 20160122 OTC MONOGRAPH FINAL part346 Unit Dose, Ltd. PETROLATUM; LIDOCAINE 600; 50 mg/g; mg/g N 20181231 67194-017_60e2a02c-f969-6478-e053-2a91aa0a2ddc 67194-017 HUMAN OTC DRUG Liprotek PETROLATUM, LIDOCAINE OINTMENT TOPICAL 20160121 OTC MONOGRAPH NOT FINAL part348 Unit Dose, Ltd. PETROLATUM; LIDOCAINE 610; 6 mg/g; mg/g N 20181231 67194-018_29db53ba-e159-7115-e054-00144ff88e88 67194-018 HUMAN OTC DRUG Numpot Topical Anesthetic LIDOCAINE, PETROLATUM OINTMENT TOPICAL 20160120 OTC MONOGRAPH FINAL part346 Unit Dose, Ltd. LIDOCAINE; PETROLATUM 50; 710 mg/g; mg/g N 20181231 67194-020_60e2a02c-f974-6478-e053-2a91aa0a2ddc 67194-020 HUMAN OTC DRUG Numfast Tetracaine Green TETRACAINE CREAM TOPICAL 20160120 OTC MONOGRAPH NOT FINAL part348 Unit Dose, Ltd. TETRACAINE 20 mg/g N 20181231 67194-022_29db6879-3419-7184-e054-00144ff88e88 67194-022 HUMAN OTC DRUG Microcaine Topical Analgesic LIDOCAINE CREAM TOPICAL 20160119 OTC MONOGRAPH FINAL part346 Unit Dose, Ltd. LIDOCAINE 50 mg/g N 20181231 67225-0001_a8085ef0-28a1-4643-94f6-1afdd8701f6f 67225-0001 HUMAN OTC DRUG Dental Clinic 2080 Cavity Protection Sodium Monofluorophosphate PASTE DENTAL 20150401 OTC MONOGRAPH FINAL part355 Aekyung Industrial Co., Ltd. SODIUM MONOFLUOROPHOSPHATE .208 g/160g E 20171231 67225-0001_f07e841e-c5bc-4c49-94ca-d34be80c1c16 67225-0001 HUMAN OTC DRUG Dental Clinic 2080 Cavity Protection Sodium Monofluorophosphate PASTE DENTAL 20121201 OTC MONOGRAPH FINAL part355 Aekyung Ind. Co., Ltd. SODIUM MONOFLUOROPHOSPHATE .156 g/120g E 20171231 67225-0002_7ae81c2f-2d34-41af-b1d4-14e7dd554a37 67225-0002 HUMAN OTC DRUG Dental Clinic 2080 K Strong Winter Green SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20140516 OTC MONOGRAPH FINAL part355 Aekyung Ind. Co., Ltd. SODIUM FLUORIDE .1 g/100g E 20171231 67225-0003_46dbc0b3-59e7-4459-8061-f4c275da7f76 67225-0003 HUMAN OTC DRUG Dental Clinic 2080 K Citrus Cool Mint SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20140516 OTC MONOGRAPH FINAL part355 Aekyung Ind. Co., Ltd. SODIUM FLUORIDE .1 g/100g E 20171231 67225-0004_bc06a34a-8980-4078-88d1-d01d3bb020b5 67225-0004 HUMAN OTC DRUG Dental Clinic 2080 Vita Care Sodium Monofluorophosphate PASTE DENTAL 20150401 OTC MONOGRAPH FINAL part355 Aekyung Industrial Co., Ltd. SODIUM MONOFLUOROPHOSPHATE .156 g/120g E 20171231 67225-0005_d0a6d756-d2cc-4b70-a598-ab48358749bf 67225-0005 HUMAN OTC DRUG Dental Clinic 2080 Fresh Up Sodium Monofluorophosphate PASTE DENTAL 20150401 OTC MONOGRAPH FINAL part355 Aekyung Industrial Co., Ltd. SODIUM MONOFLUOROPHOSPHATE .156 g/120g E 20171231 67225-0006_9fa20ec4-229b-4a93-93dd-1d6b1eb5e283 67225-0006 HUMAN OTC DRUG 2080 K Herbal Mint Sodium Fluoride PASTE DENTAL 20160707 OTC MONOGRAPH FINAL part355 Aekyung Industrial Co., Ltd. SODIUM FLUORIDE .12 g/120g N 20181231 67225-0007_231fd48c-a6ce-46b3-b90a-e5a39f92e260 67225-0007 HUMAN OTC DRUG 2080 K Original Sodium Fluoride PASTE DENTAL 20160707 OTC MONOGRAPH FINAL part355 Aekyung Industrial Co., Ltd. SODIUM FLUORIDE .12 g/120g N 20181231 67225-0008_2d25c821-e359-44bb-a34f-57d6c4f47a73 67225-0008 HUMAN OTC DRUG 2080 K Ginger Mint Sodium Fluoride PASTE DENTAL 20160707 OTC MONOGRAPH FINAL part355 Aekyung Industrial Co., Ltd. SODIUM FLUORIDE .12 g/120g N 20181231 67225-0009_5b63c38f-b307-40f1-8d85-b0365a4de261 67225-0009 HUMAN OTC DRUG 2080 Dentistry Night Fresh Dental Type Silica (Silicon Dioxide), Zinc Citrate, trihydrate, Cetylpyridinium Chloride, Dipotassium Glycyrrhizinate PASTE, DENTIFRICE DENTAL 20170203 OTC MONOGRAPH FINAL part332 Aekyung Industrial Co., Ltd. SILICON DIOXIDE 15 g/100g N 20181231 67225-0010_e0028b76-0496-4f8f-95ba-817bfc9164c1 67225-0010 HUMAN OTC DRUG 2080 Dentistry Night Repair Dental Type Silica (Silicon Dioxide), Calcium Glycerophosphate, Cetylpyridinium Chloride, Dipotassium Glycyrrhizinate PASTE, DENTIFRICE DENTAL 20170203 OTC MONOGRAPH FINAL part332 Aekyung Industrial Co., Ltd. SILICON DIOXIDE 15 g/100g N 20181231 67225-0325_1564210d-945c-4f9d-864b-f63e7c998524 67225-0325 HUMAN OTC DRUG Age 20s ESSENCE COVER PACT WHITE DEEP BE-25 Age 20s Foundation CREAM TOPICAL 20170602 OTC MONOGRAPH NOT FINAL part352 Aekyung Industrial Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE .8825; .875; .5; .375 g/12.5g; g/12.5g; g/12.5g; g/12.5g N 20181231 67225-0335_9e194963-506f-4408-895d-d94fc8952513 67225-0335 HUMAN OTC DRUG Age 20s ESSENCE COVER PACT WHITE DARK BE-35 Age 20s Foundation CREAM TOPICAL 20170602 OTC MONOGRAPH NOT FINAL part352 Aekyung Industrial Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE .8825; .875; .5; .375 g/12.5g; g/12.5g; g/12.5g; g/12.5g N 20181231 67225-0413_6cdbbb13-76cf-4001-a66a-2dbe47406dbd 67225-0413 HUMAN OTC DRUG Age 20s ESSENCE COVER PACT ORIGINAL WHITE LATTE 13 Age 20s Foundation CREAM TOPICAL 20170602 OTC MONOGRAPH NOT FINAL part352 Aekyung Industrial Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE 1.1075; .875; .5 g/12.5g; g/12.5g; g/12.5g N 20181231 67225-0421_c5859919-61ca-43e3-aa6b-58fc1e7de9d5 67225-0421 HUMAN OTC DRUG Age 20s ESSENCE COVER PACT ORIGINAL WHITE LATTE 21 Age 20s Foundation CREAM TOPICAL 20170602 OTC MONOGRAPH NOT FINAL part352 Aekyung Industrial Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE 1.1075; .875; .5 g/12.5g; g/12.5g; g/12.5g N 20181231 67225-0423_e7aa490e-64b5-410f-892e-b396737236d2 67225-0423 HUMAN OTC DRUG Age 20s ESSENCE COVER PACT ORIGINAL WHITE LATTE 23 Age 20s Foundation CREAM TOPICAL 20170602 OTC MONOGRAPH NOT FINAL part352 Aekyung Industrial Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE 1.1075; .875; .5 g/12.5g; g/12.5g; g/12.5g N 20181231 67225-0513_4376b774-6197-4a32-9602-645cbff6e804 67225-0513 HUMAN OTC DRUG Age 20s ESSENCE COVER PACT ORIGINAL PINK LATTE 13 Age 20s Foundation CREAM TOPICAL 20170602 OTC MONOGRAPH NOT FINAL part352 Aekyung Industrial Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE 1.1075; .875; .5 g/12.5g; g/12.5g; g/12.5g N 20181231 67225-0521_377f1cc5-ddfc-470a-bf0c-c114dd793a71 67225-0521 HUMAN OTC DRUG Age 20s ESSENCE COVER PACT ORIGINAL PINK LATTE 21 Age 20s Foundation CREAM TOPICAL 20170602 OTC MONOGRAPH NOT FINAL part352 Aekyung Industrial Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE 1.1075; .875; .5 g/12.5g; g/12.5g; g/12.5g N 20181231 67225-0523_a34c7f77-46bd-4fe1-8469-0ba87c4a1098 67225-0523 HUMAN OTC DRUG Age 20s ESSENCE COVER PACT ORIGINAL PINK LATTE 23 Age 20s Foundation CREAM TOPICAL 20170602 OTC MONOGRAPH NOT FINAL part352 Aekyung Industrial Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTOCRYLENE 1.1075; .875; .5 g/12.5g; g/12.5g; g/12.5g N 20181231 67226-1020_3e47d2cb-aeb6-0749-e054-00144ff8d46c 67226-1020 HUMAN OTC DRUG SkinTX Medicated Acne Wash SALICYLIC ACID LIQUID TOPICAL 20110119 OTC MONOGRAPH FINAL part333D Vivier Pharma, Inc. SALICYLIC ACID 2 g/100mL N 20181231 67226-1021_5e0d3664-b056-ba28-e053-2991aa0a8a4c 67226-1021 HUMAN OTC DRUG Medicated Wash SALICYLIC ACID LIQUID TOPICAL 20171111 OTC MONOGRAPH FINAL part333D Vivier Pharma, Inc. SALICYLIC ACID 20 mg/mL N 20191231 67226-1040_0fbce541-7cea-4523-83b3-bc8ef2a066f2 67226-1040 HUMAN OTC DRUG Seequin 4 Hydroquinone LIQUID TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 4 g/100mL E 20171231 67226-2015_615b5798-081d-2cef-e053-2991aa0a895d 67226-2015 HUMAN OTC DRUG Daily Moisturizing SPF 15 OCTINOXATE, OCTISALATE, BENZOPHENONE CREAM TOPICAL 20171111 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma Inc OCTINOXATE; OCTISALATE; BENZOPHENONE 75; 30; 30 mg/mL; mg/mL; mg/mL N 20181231 67226-2030_638c6c12-145e-aa77-e053-2991aa0ace4d 67226-2030 HUMAN OTC DRUG Sunscreen SPF 30 AVOBENZONE, OCTINOXATE, ENSULIZOLE LOTION TOPICAL 20171111 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma, Inc. AVOBENZONE; OCTINOXATE; ENSULIZOLE 25; 55; 20 mg/100mL; mg/100mL; mg/100mL N 20191231 67226-2040_a85fc760-1d86-4ff1-9f3a-5299b309e85a 67226-2040 HUMAN OTC DRUG Clarite 4 Hydroquinone CREAM TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 4 g/100mL E 20171231 67226-2045_cac1d9bf-1138-41bd-9052-4ce24e5b0b6a 67226-2045 HUMAN OTC DRUG VivierSkin Sun Protection SPF 45 ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20110325 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma, Inc. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE 4.8; 7.5; 7.5 mL/100mL; mL/100mL; mL/100mL N 20181231 67226-2050_61b75867-d4dd-550d-e053-2a91aa0a3fb7 67226-2050 HUMAN OTC DRUG Acne Treatment BENZOYL PEROXIDE LOTION TOPICAL 20111101 OTC MONOGRAPH FINAL part333D Vivier Pharma, Inc. BENZOYL PEROXIDE 50 mg/mL N 20191231 67226-2130_60243a05-eca4-8e84-e053-2991aa0aa3eb 67226-2130 HUMAN OTC DRUG Sunscreen SPF 30 AVOBENZONE, OCTINOXATE, ENSULIZOLE LOTION TOPICAL 20110322 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma, Inc. AVOBENZONE; OCTINOXATE; ENSULIZOLE 2.5; 5.5; 2 g/100mL; g/100mL; g/100mL N 20191231 67226-2140_337cf88c-f17b-448e-a2a3-48924ce302be 67226-2140 HUMAN OTC DRUG Active 4 Hydroquinone CREAM TOPICAL 20140530 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 4 g/100mL E 20171231 67226-2145_1dc862f7-951c-4365-b0ad-a3f18de4a298 67226-2145 HUMAN OTC DRUG SkinTx Daily Defense SPF 45 ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20110321 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma, Inc. ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE 4.8; 7.8; 7.5 mL/100mL; mL/100mL; mL/100mL N 20181231 67226-2231_5e0e1393-9622-24e2-e053-2a91aa0ae093 67226-2231 HUMAN OTC DRUG Triple Protection Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20171111 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma Inc TITANIUM DIOXIDE; ZINC OXIDE 100; 80 mg/mL; mg/mL N 20191231 67226-2330_57618b68-238d-4a53-b7eb-fb5843f1e510 67226-2330 HUMAN OTC DRUG Physical Facial Block SPF 30 ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20060828 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma, Inc. ZINC OXIDE; TITANIUM DIOXIDE 4.8; 6 g/100mL; g/100mL E 20171231 67226-2620_a39e0e11-37aa-4e3a-a205-2ec1a5fcba3f 67226-2620 HUMAN OTC DRUG SEEQUIN 2 Hydroquinone LIQUID TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 2 g/100mL E 20171231 67226-2621_56d067df-39e7-2314-e054-00144ff88e88 67226-2621 HUMAN OTC DRUG Advanced Skin Lightening Serum Hydroquinone LIQUID TOPICAL 20160930 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 2 g/100mL N 20181231 67226-2622_615b61a1-042b-130a-e053-2991aa0a34ed 67226-2622 HUMAN OTC DRUG Advanced Skin Lightening Serum HYDROQUINONE GEL TOPICAL 20171106 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 20 mg/mL N 20181231 67226-2720_06d2f445-cbcb-42d6-89ac-7ac89ef85093 67226-2720 HUMAN OTC DRUG Activator Light Hydroquinone LOTION TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 2 g/100mL E 20171231 67226-2820_8e8a91b1-066e-4be5-b80a-ece34d5d71e7 67226-2820 HUMAN OTC DRUG Corrector Light Hydroquinone LOTION TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 2 g/100mL E 20171231 67226-2821_b2bfcf58-8e4e-479f-b22f-c66b47e9c97a 67226-2821 HUMAN OTC DRUG Advanced Skin Lightening Cream Hydroquinone LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma, Inc. HYDROQUINONE 2 g/100mL E 20171231 67226-2822_5e0e1393-9630-24e2-e053-2a91aa0ae093 67226-2822 HUMAN OTC DRUG CORRECTOR 2 HYDROQUINONE CREAM TOPICAL 20171114 OTC MONOGRAPH NOT FINAL part358A Vivier Pharma Inc. HYDROQUINONE 2 g/100mL N 20181231 67226-2830_61b72767-ceb9-132e-e053-2a91aa0ab276 67226-2830 HUMAN OTC DRUG SHEER BROAD SPECTRUM SPF30 ZINC OXIDE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20171111 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma Inc. ZINC OXIDE; OCTINOXATE; OCTISALATE 99; 75; 50 mg/mL; mg/mL; mg/mL N 20191231 67226-2845_61b72767-ceab-132e-e053-2a91aa0ab276 67226-2845 HUMAN OTC DRUG SHEER BROAD SPECTRUM SPF45 ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20171111 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma Inc. ZINC OXIDE; OCTOCRYLENE; OCTINOXATE; OCTISALATE 99; 80; 75; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 67226-2930_615b77ff-1ebf-2ced-e053-2991aa0a3961 67226-2930 HUMAN OTC DRUG SkinTx UV Pro Broad Spectrum SPF30 ZINC OXIDE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20150514 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma Inc. ZINC OXIDE; OCTINOXATE; OCTISALATE 99; 75; 50 mg/mL; mg/mL; mg/mL N 20181231 67226-2945_615b77ff-1ecd-2ced-e053-2991aa0a3961 67226-2945 HUMAN OTC DRUG SkinTx UV Pro Broad Spectrum SPF45 ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20150514 OTC MONOGRAPH NOT FINAL part352 Vivier Pharma Inc. ZINC OXIDE; OCTOCRYLENE; OCTINOXATE; OCTISALATE 99; 80; 75; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67226-3025_3e4a5b26-ed57-5177-e054-00144ff88e88 67226-3025 HUMAN OTC DRUG SkinTx Acne Treatment System SALICYLIC ACID, BENZOYL PEROXIDE KIT TOPICAL 20110307 OTC MONOGRAPH FINAL part333D Vivier Pharma N 20181231 67226-3026_61b72767-cec7-132e-e053-2a91aa0ab276 67226-3026 HUMAN OTC DRUG Acne Treatment System BENZOYL PEROXIDE, SALICYLIC ACID KIT 20171111 OTC MONOGRAPH FINAL part333D Vivier Pharma, Inc. N 20191231 67234-001_837de2d4-b8fa-46fe-8840-e46d912e6048 67234-001 HUMAN OTC DRUG Natureplex ZINC OXIDE OINTMENT TOPICAL 20050102 OTC MONOGRAPH FINAL part347 Natureplex LLC ZINC OXIDE 400 mg/g N 20181231 67234-002_89f0e6ea-4368-417a-ad0b-9b02e69e588e 67234-002 HUMAN OTC DRUG Muscle Rub Ultra Strength MENTHOL and METHYL SALICYLATE CREAM TOPICAL 20070102 OTC MONOGRAPH NOT FINAL part348 Natureplex LLC MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .01; .15 mg/g; mg/g N 20181231 67234-007_2c217401-7e7a-48a1-a88c-ae520bfc44d7 67234-007 HUMAN OTC DRUG Acne Treatment SALICYLIC ACID GEL TOPICAL 20070102 OTC MONOGRAPH FINAL part333D Natureplex LLC SALICYLIC ACID .005 mg/g N 20181231 67234-008_23ac82ee-44e5-452d-aef5-e50e07febcd6 67234-008 HUMAN OTC DRUG Anti Itch Maximum Relief Pramoxine Hydrochloride and Menthol CREAM TOPICAL 20080102 OTC MONOGRAPH NOT FINAL part347 Natureplex LLC PRAMOXINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM 10; 10 mg/g; mg/g N 20181231 67234-009_65141127-bcd9-4d21-ae6e-fae43eb11a85 67234-009 HUMAN OTC DRUG Athlete s Foot Afac Clotrimazole CREAM TOPICAL 20080122 OTC MONOGRAPH FINAL part333C Natureplex, LLC CLOTRIMAZOLE .01 g/g N 20181231 67234-010_da2660d2-8e1a-486d-acb1-043266c9473e 67234-010 HUMAN OTC DRUG Natureplex Hydrocortisone Hydro Hydrocortisone CREAM TOPICAL 20080122 OTC MONOGRAPH NOT FINAL part348 Natureplex, LLC HYDROCORTISONE .01 g/g N 20181231 67234-014_2af194fd-04d0-4c5b-b387-024a7903c0b1 67234-014 HUMAN OTC DRUG PRO-EX Anti Fungal Clotrimazole CREAM TOPICAL 20080122 OTC MONOGRAPH FINAL part333C Natureplex, LLC CLOTRIMAZOLE .01 g/g N 20181231 67234-019_2f975105-b84b-4a9b-8189-0b9d38b05898 67234-019 HUMAN OTC DRUG Enema Mineral Oil Mineral Oil ENEMA RECTAL 20130105 OTC MONOGRAPH NOT FINAL part334 Natureplex LLC MINERAL OIL 1 mL/mL N 20181231 67234-020_c95f678d-e2a6-4ca0-b196-520cef29802c 67234-020 HUMAN OTC DRUG NATUREPLEX Enema (saline) ENEMA RECTAL 20100601 OTC MONOGRAPH NOT FINAL part334 Natureplex, LLC SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 19; 7 g/133mL; g/133mL N 20181231 67234-022_b4f894d1-39bf-41d7-8980-b9cfcc770086 67234-022 HUMAN OTC DRUG Bella Flore POVIDONE-IODINE KIT 20120102 OTC MONOGRAPH NOT FINAL part333A Natureplex LLC N 20181231 67234-023_8a8a28e4-f72c-41e2-b190-3ca26b7c89c4 67234-023 HUMAN OTC DRUG Dermamine Extra Strength Itch Stopping DIPHENHYDRAMINE and ZINC ACETATE CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part348 Natureplex LLC DIPHENHYDRAMINE; ZINC ACETATE .02; .001 mg/g; U/g N 20181231 67234-024_c69046f5-7564-4cb2-a366-c04cc67a9a13 67234-024 HUMAN OTC DRUG Natureplex Hemorrhoidal WITCH HAZEL and PHENYLEPHRINE HYDROCHLORIDE GEL TOPICAL 20140318 OTC MONOGRAPH FINAL part346 Natureplex LLC WITCH HAZEL; PHENYLEPHRINE HYDROCHLORIDE .5; .0025 mg/g; mg/g N 20181231 67234-025_1dbf3440-c1f0-4701-aa08-83717433d396 67234-025 HUMAN OTC DRUG Natureplex Hemorrhoidal GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, and PETROLATUM CREAM TOPICAL 20140301 OTC MONOGRAPH FINAL part346 Natureplex LLC GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM .144; .0025; .1; .15 mg/g; mg/g; mg/g; mg/g N 20181231 67234-027_ed14474a-c11b-44dc-89d1-3f52ea893a9d 67234-027 HUMAN OTC DRUG Scar Gel Advanced Formula ALLANTOIN CREAM TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Natureplex LLC ALLANTOIN .005 mg/g N 20181231 67234-030_222004da-172c-4964-89c2-d67e212818bc 67234-030 HUMAN OTC DRUG A and D Diaper Rash and Skin Protectant Lanolin and Petrolatum CREAM TOPICAL 20141112 OTC MONOGRAPH FINAL part347 Natureplex LLC LANOLIN; PETROLATUM .15; .53 mg/g; mg/g N 20181231 67234-031_10a5c5f6-8ba4-4b06-ba87-7fdc7da8eb39 67234-031 HUMAN OTC DRUG TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTIC BACITRACIN ZINC, NEOMYCIN SULFATE, and POLYMYXIN B SULFATE OINTMENT TOPICAL 20110803 OTC MONOGRAPH FINAL part333B Natureplex LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 U/9.4g; mg/9.4g; U/9.4g N 20181231 67234-032_c2258205-0c1d-4535-a590-8ca5f9cc0da4 67234-032 HUMAN OTC DRUG NATUREPLEX TOLNAFTATE ANTIFUNGAL TOLNAFTATE CREAM TOPICAL 19930923 OTC MONOGRAPH FINAL part333C Natureplex, LLC TOLNAFTATE 10 mg/g N 20181231 67234-035_94b69547-fb1d-4591-9e38-451521fbf64b 67234-035 HUMAN OTC DRUG ZITFREE ACNE TREATMENT BENZOYL PEROXIDE OINTMENT TOPICAL 20141201 OTC MONOGRAPH FINAL part333D Natureplex LLC BENZOYL PEROXIDE 100 mg/g N 20181231 67234-037_da4b3275-2f1b-425a-8d98-d61d3a65b87b 67234-037 HUMAN OTC DRUG BurnX Pain Relieving Burn LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20100410 OTC MONOGRAPH NOT FINAL part348 Natureplex, LLC LIDOCAINE HYDROCHLORIDE .025 g/g N 20181231 67234-038_8269c8c7-b6c3-45dc-a5e7-ffdefafcef2f 67234-038 HUMAN OTC DRUG Climax Control Benzocaine Benzocaine GEL TOPICAL 20160125 OTC MONOGRAPH FINAL part333B Natureplex LLC BENZOCAINE .075 g/g N 20181231 67234-041_682cadcc-ba9b-44c9-90cc-b6015dc4eca7 67234-041 HUMAN OTC DRUG ORAL SALINE LAXATIVE CHERRY LAXATIVE SODIUM PHOSPHATE, DIBASIC and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM LIQUID ORAL 20120831 OTC MONOGRAPH NOT FINAL part334 Natureplex, LLC SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 1.4; 6.2 g/14.7868mL; g/14.7868mL N 20181231 67234-042_b2d5e5d8-e877-4f69-b006-1e03c9cfd835 67234-042 HUMAN OTC DRUG Pediatric Saline Laxative SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM and SODIUM PHOSPHATE, DIBASIC ENEMA RECTAL 20120831 OTC MONOGRAPH NOT FINAL part334 Natureplex, LLC SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 3.5; 9.5 g/59mL; g/59mL N 20181231 67234-044_66a134b8-0438-4dfa-8701-e34f2c04827e 67234-044 HUMAN OTC DRUG ORAL SALINE LAXATIVE LEMON GINGER SODIUM PHOSPHATE, DIBASIC and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM LIQUID ORAL 20120530 OTC MONOGRAPH NOT FINAL part334 Natureplex, LLC SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 1.4; 6.2 g/14.7868mL; g/14.7868mL N 20181231 67234-047_1f92c347-487e-4a33-9014-53ae162a221d 67234-047 HUMAN OTC DRUG Skullduggery Pain Relief and Skin Protection for Tattoos Lanolin, Petrolatum and Lidocaine KIT 20030604 OTC MONOGRAPH FINAL part347 Natureplex, LLC N 20181231 67234-048_e248765f-837d-4db7-96a3-7ac5f0795318 67234-048 HUMAN OTC DRUG Kendra SKIN PROTECTION and PAIN RELIEF FOR HAIR REMOVAL Lanolin, Petrolatum and Lidocaine KIT 20030604 OTC MONOGRAPH FINAL part347 Natureplex, LLC N 20181231 67239-0201_d223f79a-1c14-414a-881a-2e47619383fb 67239-0201 HUMAN PRESCRIPTION DRUG MEPIVACAINE HYDROCHLORIDE Mepivacaine Hydrochloride INJECTION, SOLUTION SUBCUTANEOUS 20110101 ANDA ANDA088387 Safco Dental Supply Co. MEPIVACAINE HYDROCHLORIDE 30 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 67239-0202_5f5d97e8-8e63-41bb-8af0-e462bf296c63 67239-0202 HUMAN OTC DRUG Topical Anesthetic Cherry Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0203_314fcb16-e5f9-4803-916b-0d71723721fc 67239-0203 HUMAN OTC DRUG Topical Anesthetic Mint Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0204_54b4f083-6c2c-47be-9892-c757cd07c5d7 67239-0204 HUMAN OTC DRUG Topical Anesthetic Banana Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0205_947a950c-6610-4329-8770-703a129b9f71 67239-0205 HUMAN OTC DRUG Topical Anesthetic Pina Colada Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0206_7fa204a2-31c7-42bb-b68c-17166399864f 67239-0206 HUMAN OTC DRUG Topical Anesthetic Bubble Gum Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0207_34aaadde-b2fd-410b-8684-7e3f7b985c63 67239-0207 HUMAN OTC DRUG Topical Anesthetic Strawberry Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0208_2daf68dc-8cb7-4295-ac6d-b1b8dfc664eb 67239-0208 HUMAN OTC DRUG Topical Anesthetic Raspberry Benzocaine GEL DENTAL 20120806 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0211_de6563cb-660e-4f42-8613-418a20173a45 67239-0211 HUMAN OTC DRUG Sensicaine TM Extra Topical Anesthetic Benzocaine GEL DENTAL 20170430 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0212_6ab63221-90e7-48ac-b633-8f5ce3c9e1ca 67239-0212 HUMAN OTC DRUG Sensicaine TM Extra Topical Anesthetic Benzocaine GEL DENTAL 20170430 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0213_9d52bd5c-9f9d-486f-bda1-04ed1cd263d4 67239-0213 HUMAN OTC DRUG Sensicaine TM Extra Topical Anesthetic Benzocaine GEL DENTAL 20170430 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0214_45e83cb5-8009-4901-b5d4-97bad5477d35 67239-0214 HUMAN OTC DRUG Sensicaine TM Extra Topical Anesthetic Benzocaine GEL DENTAL 20170430 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0215_4f577ef7-7346-4722-9568-bf756b716889 67239-0215 HUMAN OTC DRUG Sensicaine TM Extra Topical Anesthetic Benzocaine GEL DENTAL 20170430 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0216_d340f69f-c4de-4cca-a07f-ee6d85056adc 67239-0216 HUMAN OTC DRUG Sensicaine TM Extra Topical Anesthetic Benzocaine GEL DENTAL 20170430 OTC MONOGRAPH NOT FINAL part356 Safco Dental Supply Co. BENZOCAINE 200 mg/g N 20181231 67239-0240_5f4a6a5a-dd97-46bc-aa81-866286a54830 67239-0240 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate INJECTION, SOLUTION SUBCUTANEOUS 20111107 ANDA ANDA088390 Safco Dental Supply Co LIDOCAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE 20; .01 mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 67253-011_f00c2309-0a9d-4ee8-b88d-0f20fff14698 67253-011 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140501 20200630 ANDA ANDA065330 Par Pharmaceutical CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67253-141_ef265f67-ee55-47b7-9f2b-a4d4dfd51096 67253-141 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19880225 20180430 ANDA ANDA062881 DAVA Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67253-144_87241414-a498-46bb-b809-ba3930641ce7 67253-144 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20140801 ANDA ANDA064076 DAVA Pharmaceuticals Inc AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 67253-146_87241414-a498-46bb-b809-ba3930641ce7 67253-146 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20140801 ANDA ANDA065387 DAVA Pharmaceuticals Inc AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 67253-147_87241414-a498-46bb-b809-ba3930641ce7 67253-147 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20140801 ANDA ANDA065378 DAVA Pharmaceuticals Inc AMOXICILLIN 200 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 67253-148_87241414-a498-46bb-b809-ba3930641ce7 67253-148 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20140801 ANDA ANDA065387 DAVA Pharmaceuticals Inc AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 67253-149_87241414-a498-46bb-b809-ba3930641ce7 67253-149 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20140801 ANDA ANDA065378 DAVA Pharmaceuticals Inc AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 67253-150_87241414-a498-46bb-b809-ba3930641ce7 67253-150 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20140801 ANDA ANDA064076 DAVA Pharmaceuticals Inc AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 67253-180_5ad2817a-6971-4a81-975b-53d91316496c 67253-180 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19880225 20200930 ANDA ANDA062882 Par Pharmaceutical AMPICILLIN TRIHYDRATE 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67253-181_5ad2817a-6971-4a81-975b-53d91316496c 67253-181 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19880225 20200930 ANDA ANDA062882 Par Pharmaceutical AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67253-182_5ad2817a-6971-4a81-975b-53d91316496c 67253-182 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin SUSPENSION ORAL 19890210 20200831 ANDA ANDA062982 Par Pharmaceutical AMPICILLIN TRIHYDRATE 25 mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67253-183_5ad2817a-6971-4a81-975b-53d91316496c 67253-183 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin SUSPENSION ORAL 19890210 20200831 ANDA ANDA062982 Par Pharmaceutical AMPICILLIN TRIHYDRATE 50 mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67253-191_0353c7a7-53e1-4628-8585-049afbc48c1b 67253-191 HUMAN PRESCRIPTION DRUG bicalutamide bicalutamide TABLET, FILM COATED ORAL 20090706 ANDA ANDA077973 Dava Pharmaceuticals, Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] E 20171231 67253-200_2245a54a-72e2-47fe-b186-08803bc54530 67253-200 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 20200531 ANDA ANDA062936 Par Pharmaceutical PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67253-201_2245a54a-72e2-47fe-b186-08803bc54530 67253-201 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 20201231 ANDA ANDA062935 Par Pharmaceutical PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67253-233_31047631-0abc-4261-a220-8e7595c7e434 67253-233 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20140801 ANDA ANDA065257 Par Pharmaceutical CEFPROZIL 125 mg/5mL N 20181231 67253-234_31047631-0abc-4261-a220-8e7595c7e434 67253-234 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil POWDER, FOR SUSPENSION ORAL 20140801 ANDA ANDA065257 Par Pharmaceutical CEFPROZIL 250 mg/5mL N 20181231 67253-320_e0282db0-3d84-4109-abfa-0552b767e1c1 67253-320 HUMAN PRESCRIPTION DRUG METHOTREXATE METHOTREXATE TABLET ORAL 19531207 NDA NDA008085 DAVA Pharmaceuticals, Inc. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 67253-380_59fbf3a7-6cfa-41f5-b6d0-31f1707137ae 67253-380 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20040610 ANDA ANDA076161 DAVA Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67253-381_59fbf3a7-6cfa-41f5-b6d0-31f1707137ae 67253-381 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20040610 ANDA ANDA076161 DAVA Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67253-382_59fbf3a7-6cfa-41f5-b6d0-31f1707137ae 67253-382 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20040610 ANDA ANDA076161 DAVA Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67253-383_59fbf3a7-6cfa-41f5-b6d0-31f1707137ae 67253-383 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20040610 ANDA ANDA076161 DAVA Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67253-388_1c692b78-9464-4f4f-abcd-c14e0eb8fffc 67253-388 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840911 20190731 ANDA ANDA062500 Par Pharmaceutical DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 67253-389_1c692b78-9464-4f4f-abcd-c14e0eb8fffc 67253-389 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840911 20200630 ANDA ANDA062500 Par Pharmaceutical DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 67253-391_65ef1dc6-bd68-449f-941c-050af34a20e7 67253-391 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 19840911 20200831 ANDA ANDA062505 Par Pharmaceutical DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 67253-460_6a545ff2-035a-4cce-bd27-b6851f7d2e91 67253-460 HUMAN PRESCRIPTION DRUG GlyBURIDE GlyBURIDE TABLET ORAL 19971222 ANDA ANDA074591 Par Pharmaceutical GLYBURIDE 1.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 67253-461_6a545ff2-035a-4cce-bd27-b6851f7d2e91 67253-461 HUMAN PRESCRIPTION DRUG GlyBURIDE GlyBURIDE TABLET ORAL 19971222 ANDA ANDA074591 Par Pharmaceutical GLYBURIDE 3 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 67253-462_6a545ff2-035a-4cce-bd27-b6851f7d2e91 67253-462 HUMAN PRESCRIPTION DRUG GlyBURIDE GlyBURIDE TABLET ORAL 19971222 ANDA ANDA074591 Par Pharmaceutical GLYBURIDE 6 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 67253-580_c972af96-dc17-4d94-a107-36dc0f2ab158 67253-580 HUMAN PRESCRIPTION DRUG Rheumatrex Dose Pack Methotrexate TABLET ORAL 19531207 NDA NDA008085 Par Pharmaceutical METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 67253-651_13c1a842-53e3-4647-94d3-17a26b4c283e 67253-651 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 19470728 NDA NDA006188 DAVA Pharmaceuticals, Inc. PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 67253-660_6456d188-4ee2-4630-bffc-d41e04d17e53 67253-660 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 19710603 ANDA ANDA080157 DAVA Pharmaceuticals, Inc. PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] N 20181231 67253-700_573267e7-5404-4c76-ac0a-383dd8606105 67253-700 HUMAN PRESCRIPTION DRUG SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE CAPSULE ORAL 20061104 ANDA ANDA075352 Par Pharmaceutical SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 67253-741_4ef3e736-8970-463a-8b22-0057c07525e1 67253-741 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 19930927 20180331 ANDA ANDA074270 DAVA Pharmaceuticals, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 67253-900_b447d0c5-2e2a-4f64-b6db-55a7272aeaeb 67253-900 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Par Pharmaceutical ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67253-901_b447d0c5-2e2a-4f64-b6db-55a7272aeaeb 67253-901 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Par Pharmaceutical ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67253-902_b447d0c5-2e2a-4f64-b6db-55a7272aeaeb 67253-902 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Par Pharmaceutical ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67253-903_b447d0c5-2e2a-4f64-b6db-55a7272aeaeb 67253-903 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 Par Pharmaceutical ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-0007_3fb41bbb-ff28-22c6-e054-00144ff8d46c 67296-0007 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 19890503 ANDA ANDA071611 RedPharm Drug, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67296-0016_63fa3273-38d3-4855-aa4d-a4ff5b572fd2 67296-0016 HUMAN PRESCRIPTION DRUG Hydrocodone Acetaminophen HYDROCODONE, ACETAMINOPHEN TABLET ORAL 20110303 ANDA ANDA081083 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 750 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67296-0023_1d333c09-ee5d-4d2a-bf1e-a68b939794f7 67296-0023 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100128 ANDA ANDA061926 RedPharm Drug Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 67296-0027_3fb514f8-ea98-60ca-e054-00144ff8d46c 67296-0027 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET ORAL 20160509 ANDA ANDA040185 RedPharm Drug, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 67296-0041_3175135b-1d6e-4dab-bb21-ed2c73d4a963 67296-0041 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20101007 ANDA ANDA088628 RedPharm Drug Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 CIII E 20171231 67296-0042_38ef1f00-b8c5-4070-b518-8a3396b694a4 67296-0042 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19880415 ANDA ANDA071194 RedPharm Drug Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67296-0044_41fb623a-764f-35e6-e054-00144ff8d46c 67296-0044 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 20010101 ANDA ANDA064071 RedPharm Drug, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67296-0053_c9a70da5-765d-4c5d-a80c-34856c88338e 67296-0053 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20070101 ANDA ANDA077797 RedPharm Drug Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 67296-0055_39e6ab5d-c74c-48c5-a9af-6af8d0e8c4e8 67296-0055 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20101207 ANDA ANDA088618 RedPharm Drug Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 67296-0065_57e81711-44b9-2eee-e053-2991aa0aee26 67296-0065 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET ORAL 20110706 ANDA ANDA040419 RedPharm Drug ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 67296-0073_3fc64a22-9db8-2117-e054-00144ff88e88 67296-0073 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090101 ANDA ANDA063083 RedPharm Drug, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 67296-0084_41d6e67d-3ae6-6aba-e054-00144ff8d46c 67296-0084 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20130101 ANDA ANDA071321 RedPharm Drug, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-0086_4e8ebc4a-9a14-749a-e054-00144ff8d46c 67296-0086 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 RedPharm Drug, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 67296-0106_1404b726-4ca2-44df-91ce-afabe0525ce1 67296-0106 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20100712 ANDA ANDA074421 RedPharm Drug Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 67296-0122_cfb75e69-e5a4-4b51-ab3c-e0e4cfa4b709 67296-0122 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20110120 ANDA ANDA062286 RedPharm Drug Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 67296-0123_4d995e8e-2359-26c6-e054-00144ff8d46c 67296-0123 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 RedPharm Drug, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 67296-0126_41d74ebf-7776-0f7f-e054-00144ff8d46c 67296-0126 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20120101 ANDA ANDA085223 RedPharm Drug, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 67296-0129_3fc80822-6257-4937-e054-00144ff8d46c 67296-0129 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20160413 ANDA ANDA072741 RedPharm Drug, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 67296-0140_c7dc85a9-193a-4f03-983d-1f6c8da6537e 67296-0140 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA085162 RedPharm Drug Inc. PREDNISONE 10 mg/1 E 20171231 67296-0143_428910f6-f47a-3e60-e054-00144ff8d46c 67296-0143 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20000101 ANDA ANDA072926 RedPharm Drug, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-0144_5a1db904-b5c1-c355-e053-2a91aa0a381d 67296-0144 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 RedPharm Drug, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 67296-0152_291ca54c-dadb-4e47-abb3-8f937ab6ef08 67296-0152 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20100701 ANDA ANDA088496 RedPharm Drug Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 67296-0154_4c8fe3c9-0537-4fda-aef5-918f0a961a8b 67296-0154 HUMAN PRESCRIPTION DRUG Avelox moxifloxacin hydrochloride TABLET, FILM COATED ORAL 20110225 NDA NDA021085 RedPharm Drug Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 67296-0192_42780e26-52d8-5914-e054-00144ff88e88 67296-0192 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065153 RedPharm Drug, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 67296-0213_4275ae85-743e-0cd5-e054-00144ff8d46c 67296-0213 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062936 RedPharm Drug, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67296-0220_e8c2f6fc-ccc4-47c8-9091-0a9ee553ef22 67296-0220 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20071101 ANDA ANDA065291 RedPharm Drug Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 67296-0227_3fc95839-6b78-1303-e054-00144ff88e88 67296-0227 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100101 ANDA ANDA076899 RedPharm Drug, Inc. TRIMETHOPRIM; SULFAMETHOXAZOLE 160; 800 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 67296-0238_41fc3081-a71b-65f6-e054-00144ff8d46c 67296-0238 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET ORAL 20010101 ANDA ANDA040268 RedPharm Drug, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 67296-0240_4199a62e-b61f-31a2-e054-00144ff8d46c 67296-0240 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 19970423 ANDA ANDA074578 RedPharm Drug, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 67296-0247_42897c99-311f-55bf-e054-00144ff8d46c 67296-0247 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030213 ANDA ANDA087342 RedPharm Drug, Inc. PREDNISONE 20 mg/1 N 20181231 67296-0271_15a13d7b-63f9-4c78-9ca8-2416bf41d70a 67296-0271 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 RedPharm Drug Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 67296-0291_2650d9ad-539b-74bc-e054-00144ff8d46c 67296-0291 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20150101 ANDA ANDA071307 Redpharm Drug, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-0299_5c3ca320-4e49-31d9-e053-2991aa0a1f64 67296-0299 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100118 ANDA ANDA040736 RedPharm Drug, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 67296-0306_8aac15c2-c997-4aae-a382-b1c424e930f8 67296-0306 HUMAN PRESCRIPTION DRUG LORAZEPAM lorazepam TABLET ORAL 19911031 ANDA ANDA072927 RedPharm Drug Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67296-0315_93149232-fbfa-443b-ae5b-b7302ebe5442 67296-0315 HUMAN PRESCRIPTION DRUG clindamycin hydrochloride clindamycin hydrochloride CAPSULE ORAL 20061101 ANDA ANDA065442 RedPharm Drug Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 67296-0319_3fca0503-d0d7-282b-e054-00144ff88e88 67296-0319 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20080801 ANDA ANDA070624 RedPharm Drug, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0320_76d06a53-0446-440a-9786-8ced37e43f04 67296-0320 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051201 ANDA ANDA065229 RedPharm Drug Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 67296-0332_428a9232-a0f6-10a9-e054-00144ff8d46c 67296-0332 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 RedPharm Drug, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67296-0346_3fcb106c-f72f-17d9-e054-00144ff8d46c 67296-0346 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20110101 ANDA ANDA073192 RedPharm Drug, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 67296-0355_4d9ac5e4-2687-71f7-e054-00144ff8d46c 67296-0355 HUMAN PRESCRIPTION DRUG OXYCODONE AND ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN TABLET ORAL 20110308 ANDA ANDA087463 RedPharm Drug, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-0362_96235673-b0d8-40aa-9115-c181a416af00 67296-0362 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 20100422 ANDA ANDA040409 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67296-0369_1cc23bf2-170e-4170-9299-bfaa55d06ec7 67296-0369 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen TABLET ORAL 20110118 ANDA ANDA073517 RedPharm Drug Inc. KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67296-0372_9ee3191e-6836-4324-892c-1ccd55baf473 67296-0372 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 RedPharm Drug Inc. LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 67296-0375_75712ad2-36fe-4a9d-a722-970e4e594bec 67296-0375 HUMAN PRESCRIPTION DRUG ACYCLOVIR acyclovir TABLET ORAL 20090401 ANDA ANDA074596 RedPharm Drug Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 67296-0377_23e2cf2e-a51b-4c3a-82b9-b3aaf3d52290 67296-0377 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040769 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 750 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 67296-0381_1cb85a09-685d-498e-89e1-d4cf7666ab19 67296-0381 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20090807 ANDA ANDA088349 RedPharm Drug Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 67296-0387_4196e73b-5aed-2ede-e054-00144ff8d46c 67296-0387 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19860825 ANDA ANDA071017 RedPharm Drug, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 67296-0388_603edfa5-9fe2-4bc9-e053-2991aa0a1640 67296-0388 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 RedPharm Drug, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67296-0389_3fcc00a9-6610-6568-e054-00144ff88e88 67296-0389 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20101115 ANDA ANDA076003 RedPharm Drug, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 67296-0396_419479ee-c1e2-306c-e054-00144ff8d46c 67296-0396 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 RedPharm Drug, Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 67296-0406_3fdacbdf-15c5-6a44-e054-00144ff88e88 67296-0406 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 RedPharm Drug, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0431_c9495efd-8822-45ae-ac8c-2ede51b63b23 67296-0431 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080201 ANDA ANDA074112 RedPharm Drug Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67296-0447_dcde7446-4610-452d-ac4b-9eb57f78c252 67296-0447 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20100218 ANDA ANDA078218 RedPharm Drug Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 67296-0464_3fdb8746-3960-1123-e054-00144ff88e88 67296-0464 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20050825 ANDA ANDA065136 RedPharm Drug, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 67296-0466_3409547b-5675-4e7d-8498-27b3138012b7 67296-0466 HUMAN PRESCRIPTION DRUG Hydrocodone bitartrate and acetaminophen hydrocodone bitartrate and acetaminophen TABLET ORAL 20100118 ANDA ANDA040729 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 67296-0469_8c09ec2d-1a14-4b90-9d22-beeeb7a40a5c 67296-0469 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070501 ANDA ANDA065264 RedPharm Drug Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 67296-0470_6ba7a36b-e85b-44e0-b066-967c9a5a81fe 67296-0470 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 19981202 ANDA ANDA089971 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67296-0474_407fe0e4-f1ea-4876-e054-00144ff88e88 67296-0474 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20101025 ANDA ANDA076899 RedPharm Drug, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 67296-0492_0537f016-22d4-4f35-9a27-b41399c619c0 67296-0492 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Tablets Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040748 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 67296-0499_fcf959cd-925b-4eb1-8a7a-b5e25e64cad0 67296-0499 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20100218 ANDA ANDA040746 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 67296-0505_f44273ab-8fd1-4b8f-92a8-b57e5d6f0baa 67296-0505 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 RedPharm Drug, Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV E 20171231 67296-0506_0f905f40-eed8-47a7-bd55-0fdacc5fcc55 67296-0506 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060501 ANDA ANDA071135 RedPharm Drug Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67296-0511_40d145e6-13f8-41ac-e054-00144ff8d46c 67296-0511 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET ORAL 19980617 ANDA ANDA074754 RedPharm Drug, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 67296-0515_300e099d-aa1b-460a-8b1d-44765cfdbbac 67296-0515 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 20060119 ANDA ANDA040655 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67296-0522_09105b89-85a1-40da-a83b-5d3c887f1746 67296-0522 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 RedPharm Drug Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 67296-0527_94abb33a-586c-4d91-8253-79e050a023d1 67296-0527 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100716 ANDA ANDA070719 RedPharm Drug Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67296-0529_ac20e366-ef84-4159-bddc-a4b10ff33f3a 67296-0529 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20080601 ANDA ANDA074112 RedPharm ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67296-0537_89666922-fdfa-4644-a2e9-678c1836d74c 67296-0537 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070504 ANDA ANDA078413 RedPharm Drug, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 67296-0538_5b1d2ccf-10ff-43ba-9f4e-5d0722a91f1f 67296-0538 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 RedPharm Drug Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0542_0e9d8cc1-dd98-48a8-ac5c-01c3ed29670b 67296-0542 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020702 ANDA ANDA075944 RedPharm Drug Inc. LISINOPRIL 20 mg/1 N 20181231 67296-0543_6150bd37-2019-48fa-8dde-5b361f61cedc 67296-0543 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride tablet TABLET ORAL 20110404 ANDA ANDA076089 RedPharm Drug Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 67296-0544_980307ab-36fe-453a-b5e4-eaf528919dd1 67296-0544 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 RedPharm Drug Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII E 20171231 67296-0554_40e23a87-d8c1-2f03-e054-00144ff88e88 67296-0554 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20110211 UNAPPROVED DRUG OTHER RedPharm Drug, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 67296-0556_d13edce7-4b1b-418d-9879-54d1436d9a99 67296-0556 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20020917 ANDA ANDA075907 RedPharm Drug Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 67296-0559_40e35fa9-9cff-04f1-e054-00144ff8d46c 67296-0559 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20050114 ANDA ANDA077095 RedPharm Drug, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67296-0560_08ca2c4e-2f88-4628-98c6-642874a35c48 67296-0560 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20070401 ANDA ANDA018851 RedPharm Drug Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 67296-0561_40d5f084-756e-33cf-e054-00144ff8d46c 67296-0561 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 RedPharm Drug, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0564_40d4ef22-f130-0667-e054-00144ff8d46c 67296-0564 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET ORAL 20060731 ANDA ANDA040712 RedPharm Drug, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 67296-0567_8b3f6f42-e692-4b93-9e10-1537261b6d08 67296-0567 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100113 ANDA ANDA040682 RedPharm Drug Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67296-0570_40e45126-37f0-1c38-e054-00144ff8d46c 67296-0570 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET ORAL 19960725 ANDA ANDA040120 RedPharm Drug, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 67296-0574_3f875486-bfd5-423f-8c77-5852c5fa7ed0 67296-0574 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 RedPharm Drug Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0577_4d9cd6b2-32a0-539d-e054-00144ff88e88 67296-0577 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 RedPharm Drug, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 67296-0579_98eb16dd-de60-471b-a2da-dc9334f7e409 67296-0579 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20090801 ANDA ANDA077859 RedPharm Drug Inc. CIPROFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 67296-0580_3392ce15-9b61-4777-8785-fa1d200ae385 67296-0580 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 RedPharm Drug Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 67296-0581_c69fc778-67bf-40cf-b91a-f5e1e98e5875 67296-0581 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 RedPharm Drug Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67296-0583_40e525f9-866b-1e39-e054-00144ff88e88 67296-0583 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 RedPharm Drug, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0584_8a27ef49-e58a-4860-8a49-b98d11f1bf7b 67296-0584 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 RedPharm Drug Inc. LEVOFLOXACIN 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 67296-0586_f988da15-db11-448a-b10b-e06ed3dbb758 67296-0586 HUMAN PRESCRIPTION DRUG LEVAQUIN levofloxacin TABLET, FILM COATED ORAL 19961220 NDA NDA020634 RedPharm Drug Inc. LEVOFLOXACIN 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 67296-0589_fae37249-5c97-450a-89d2-fb3639833b6b 67296-0589 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 20060119 ANDA ANDA040656 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67296-0590_f4127116-3810-414d-9acf-ddb8e16fffbc 67296-0590 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20051208 ANDA ANDA065276 RedPharm Drug Inc. CEFPROZIL 500 mg/1 E 20171231 67296-0595_1f185c52-0399-4844-8e3e-6b48c6c221b1 67296-0595 HUMAN PRESCRIPTION DRUG ETODOLAC etodolac TABLET, FILM COATED ORAL 20081201 ANDA ANDA074819 RedPharm Drug Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0598_410bb1b0-e230-463b-e054-00144ff8d46c 67296-0598 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20110201 UNAPPROVED DRUG OTHER RedPharm Drug, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 67296-0599_066c92b9-dd45-47a4-8eca-28a553e0fb96 67296-0599 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 RedPharm Drug Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 67296-0600_e59e1b07-a2b8-4d9b-9536-1734234d78dc 67296-0600 HUMAN PRESCRIPTION DRUG PREDNISONE prednisone TABLET ORAL 20030212 ANDA ANDA040392 RedPharm Drug Inc. PREDNISONE 20 mg/1 E 20171231 67296-0602_5c51a954-e9a5-46e0-96fd-ae310d246b0c 67296-0602 HUMAN PRESCRIPTION DRUG PREDNISONE prednisone TABLET ORAL 20020712 ANDA ANDA040256 RedPharm Drug Inc. PREDNISONE 10 mg/1 E 20171231 67296-0608_2b413941-3bde-4c99-8778-b08bd8feae88 67296-0608 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin hydrochloride TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 RedPharm Drug Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 67296-0613_414a7bf2-7435-0d18-e054-00144ff8d46c 67296-0613 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070601 ANDA ANDA040702 RedPharm Drug, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67296-0616_2af471ba-4ea3-48ee-85a2-d013e958abbe 67296-0616 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20050911 ANDA ANDA065271 RedPharm Drug Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 67296-0618_aa400ebf-b711-4302-acae-5f6b8122f576 67296-0618 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 RedPharm Drug Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0619_076feca1-d3a1-4733-8fbc-176063693b3a 67296-0619 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 RedPharm Drug Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 67296-0620_266375f9-0826-434d-99fe-bd6b47bb0a89 67296-0620 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 RedPharm Drug Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 67296-0622_280a6a29-4cb2-471a-a85b-6604a2b60118 67296-0622 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20051117 ANDA ANDA077321 RedPharm Drug Inc. LISINOPRIL 10 mg/1 E 20171231 67296-0627_33b58390-3857-4813-a4e4-a32601166209 67296-0627 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 RedPharm Drug Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 67296-0628_a11bffa2-a62e-467f-819c-bbabe82bb568 67296-0628 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20060329 ANDA ANDA065255 RedPharm Drug Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 67296-0630_365c85fe-7466-4687-a6a1-0a36772a082f 67296-0630 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 RedPharm Drug Inc. LISINOPRIL 20 mg/1 N 20181231 67296-0642_fc24c4f6-e7fe-42a2-b994-3c5be77b31f5 67296-0642 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 19960412 ANDA ANDA040157 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 750 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67296-0643_3632a93c-5fcc-423e-b268-fbdc4165676e 67296-0643 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 19960229 ANDA ANDA040144 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67296-0648_4138311a-7765-3de5-e054-00144ff88e88 67296-0648 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 RedPharm Drug, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 67296-0648_733c7067-a5bc-402a-acba-69d784b6f2a2 67296-0648 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20080630 ANDA ANDA040804 RedPharm Drug Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 67296-0649_d0ef9b30-5af2-41e1-ab50-29c6562dca8f 67296-0649 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 20000531 ANDA ANDA040356 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67296-0650_73b6c4d0-18f6-4a87-b0f4-14a502f6f98c 67296-0650 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 RedPharm Drug Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 67296-0651_096ab05e-19ed-4a20-b014-d9c0bab6fb19 67296-0651 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 19960426 ANDA ANDA040119 RedPharm Drug Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL CV E 20171231 67296-0658_fda7b707-6391-403d-afd8-f825dc76777c 67296-0658 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20110110 ANDA ANDA073652 RedPharm Drug Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 67296-0671_1fbe2e01-e100-4324-91b8-06254f08f604 67296-0671 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 RedPharm Drug Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 67296-0672_881854c7-5b09-4a6a-8b47-dd6018bceb40 67296-0672 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 19920731 NDA AUTHORIZED GENERIC NDA019787 RedPharm Drug Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 67296-0673_c993ef46-71d6-4118-9749-73f347cd10a7 67296-0673 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 19920731 NDA AUTHORIZED GENERIC NDA019787 RedPharm Drug Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 67296-0674_70cf4771-54a3-45ab-8020-45d0e9a0afad 67296-0674 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 RedPharm Drug Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 67296-0676_f78df56b-0a2e-402a-be14-15350eaf5318 67296-0676 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 RedPharm Drug Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 67296-0677_18070724-8a6b-4386-8c8e-4021869d3e21 67296-0677 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 RedPharm Drug Inc. CAPTOPRIL 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 67296-0678_0188b189-ceb0-492d-a252-f00de0f616a2 67296-0678 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 RedPharm Drug Inc. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 67296-0681_1ba40f55-ff0f-4b7d-b104-ce85f04cf9c2 67296-0681 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET ORAL 20070905 ANDA ANDA078251 RedPharm Drug Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 67296-0683_c20e9153-7427-44bd-9806-bc1a5fd1e439 67296-0683 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 RedPharm Drug Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 67296-0700_415c945b-6c6f-2a55-e054-00144ff8d46c 67296-0700 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 RedPharm Drug, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67296-0706_59914d49-61d3-1634-e053-2991aa0a1041 67296-0706 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 RedPharm Drug, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 67296-0708_415eb16c-2065-2ec7-e054-00144ff88e88 67296-0708 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 19931222 ANDA ANDA074201 RedPharm Drug, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0709_41605713-726d-5a57-e054-00144ff88e88 67296-0709 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 RedPharm Drug, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67296-0711_416084e3-c5ac-17c2-e054-00144ff8d46c 67296-0711 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20030129 ANDA ANDA040489 RedPharm Drug, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67296-0712_41715402-1b26-73d1-e054-00144ff8d46c 67296-0712 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20020129 ANDA ANDA075967 RedPharm Drug, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67296-0716_8253cee0-e372-4f2c-9f90-2b26d31123d6 67296-0716 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20080201 ANDA ANDA065109 RedPharm Drug Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 67296-0718_b52013af-ca95-4ef1-bcfd-15d49dd04df7 67296-0718 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 RedPharm Drug Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 67296-0719_0253ef3f-b35b-4f42-ab27-75b3e66ca2a7 67296-0719 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN ydrocodone bitartrate and acetaminophen TABLET ORAL 19960222 ANDA ANDA040143 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 650 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67296-0721_4171e196-8f23-276a-e054-00144ff8d46c 67296-0721 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 RedPharm Drug, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-0723_4172e7ee-58e2-5aef-e054-00144ff8d46c 67296-0723 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 RedPharm Drug, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0724_4180c1d6-1aad-470e-e054-00144ff88e88 67296-0724 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20060822 ANDA ANDA076817 RedPharm Drug, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 67296-0726_4a401ce3-1d88-427f-a854-9e7283ec0aaa 67296-0726 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20100518 ANDA ANDA077657 RedPharm Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 67296-0727_4175d760-a84e-0b7f-e054-00144ff88e88 67296-0727 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET ORAL 19980301 ANDA ANDA040268 RedPharm Drug, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 67296-0737_417468df-5361-484b-e054-00144ff88e88 67296-0737 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/ Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 RedPharm Drug, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 67296-0744_4181a7ac-2e85-68d4-e054-00144ff88e88 67296-0744 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA077438 RedPharm Drug, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 67296-0750_4182c956-eb34-1d4b-e054-00144ff88e88 67296-0750 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 RedPharm Drug, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67296-0751_418326bc-9431-63ba-e054-00144ff8d46c 67296-0751 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 RedPharm Drug, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67296-0753_4183806e-85ee-72f2-e054-00144ff8d46c 67296-0753 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 RedPharm Drug, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67296-0755_962c51e5-5728-4c10-b3ed-d58aad030262 67296-0755 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 RedPharm Drug Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 67296-0756_418468ed-a7a3-53e1-e054-00144ff88e88 67296-0756 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 RedPharm Drug, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 67296-0759_2ac71f36-5d44-41fd-b850-d3c20d968623 67296-0759 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET ORAL 20081121 ANDA ANDA078616 RedPharm Drug Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] E 20171231 67296-0765_4185590d-0198-72bb-e054-00144ff88e88 67296-0765 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070406 ANDA ANDA065330 RedPharm Drug, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67296-0801_d5691a6a-4f57-4ddc-8ee7-0d2b56cf43ed 67296-0801 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE Acetazolamide TABLET ORAL 19780331 ANDA ANDA084840 RedPharm Drug Inc. ACETAZOLAMIDE 250 1/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 67296-0802_428b176a-a1b7-2f8a-e054-00144ff8d46c 67296-0802 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 RedPharm Drug, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67296-0803_8fa98bad-bdd8-444f-abc6-0b864ea000c0 67296-0803 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 RedPharm Drug Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 67296-0804_a6765670-7036-4d4b-9349-94969b6841d4 67296-0804 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen TABLET ORAL 20000531 ANDA ANDA040355 RedPharm Drug Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 67296-0822_ad7a1d63-e799-43b4-9c23-f426151ade6e 67296-0822 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 RedPharm Drug Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67296-0823_428bc6c6-5153-4f9a-e054-00144ff8d46c 67296-0823 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 RedPharm Drug, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0832_566b2288-8ad3-2850-e054-00144ff88e88 67296-0832 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20131018 ANDA ANDA091393 RedPharm Drug, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-0853_429e98d2-6da5-559f-e054-00144ff88e88 67296-0853 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 RedPharm Drug, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 67296-0855_429c8f4b-e932-68ca-e054-00144ff8d46c 67296-0855 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20000101 ANDA ANDA070184 RedPharm Drug, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 67296-0876_42b31ac0-9de2-5763-e054-00144ff8d46c 67296-0876 HUMAN OTC DRUG diphenhydramine hydrochloride diphenhydramine hydrochloride CAPSULE ORAL 20000501 OTC MONOGRAPH FINAL part341 RedPharm Drug, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 67296-0877_4d9f65f2-7a3b-67e4-e054-00144ff8d46c 67296-0877 HUMAN PRESCRIPTION DRUG IBU IBU TABLET ORAL 20081120 ANDA ANDA075682 RedPharm Drug, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0880_42a00e68-d00d-219a-e054-00144ff88e88 67296-0880 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 RedPharm Drug, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 67296-0883_43048cc4-fc69-114a-e054-00144ff8d46c 67296-0883 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 RedPharm Drug, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 67296-0886_4d9ef14a-4813-4fcf-e054-00144ff8d46c 67296-0886 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 RedPharm Drug, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0894_4dae3b5e-c450-3de5-e054-00144ff8d46c 67296-0894 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 RedPharm Drug, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 67296-0897_4304fbd4-b0a5-08a6-e054-00144ff88e88 67296-0897 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA201043 RedPharm Drug, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 67296-0902_4daf8ebb-5f54-30a0-e054-00144ff8d46c 67296-0902 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 RedPharm Drug, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 67296-0913_4db219dc-ea49-490c-e054-00144ff88e88 67296-0913 HUMAN PRESCRIPTION DRUG IBU IBU TABLET ORAL 20081120 ANDA ANDA075682 RedPharm Drug, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-0920_4e167845-672e-3e6c-e054-00144ff8d46c 67296-0920 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20061004 ANDA ANDA077912 RedPharm Drug, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 67296-0921_4e167f20-aa78-0171-e054-00144ff88e88 67296-0921 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 RedPharm Drug, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 67296-0932_4db1ade6-b7b1-0024-e054-00144ff8d46c 67296-0932 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 RedPharm Drug, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67296-0937_4e14ecee-0ca2-66f0-e054-00144ff8d46c 67296-0937 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19861001 ANDA ANDA070994 RedPharm Drug, Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 67296-0947_4e16fde5-0850-56a9-e054-00144ff8d46c 67296-0947 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 RedPharm Drug, Inc. BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE 5; 6.25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67296-0958_4e145198-1bfa-4331-e054-00144ff88e88 67296-0958 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20070328 ANDA ANDA074174 RedPharm Drug, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-0961_4e04403b-43a4-15c0-e054-00144ff88e88 67296-0961 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 ANDA ANDA077397 RedPharm Drug, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67296-0972_4e1308ab-9519-1adc-e054-00144ff88e88 67296-0972 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 RedPharm Drug, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 67296-0974_4e0241c6-9fca-3740-e054-00144ff8d46c 67296-0974 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 RedPharm Drug, Inc. PREDNISONE 20 mg/1 N 20181231 67296-0975_4e018151-a16a-2b32-e054-00144ff88e88 67296-0975 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 RedPharm Drug, Inc. LEVOFLOXACIN 250 mg/1 N 20181231 67296-0977_4e009b28-c13f-4beb-e054-00144ff8d46c 67296-0977 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076710 RedPharm Drug, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 67296-0985_4df087e3-ea81-551d-e054-00144ff88e88 67296-0985 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 RedPharm Drug, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 67296-0988_4def54f4-0880-61d7-e054-00144ff8d46c 67296-0988 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 RedPharm Drug, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67296-0993_4dee3f39-f736-329c-e054-00144ff8d46c 67296-0993 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20130531 ANDA ANDA203399 RedPharm Drug, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 67296-1006_4e180cd5-2fd3-5047-e054-00144ff88e88 67296-1006 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 RedPharm Drug, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 67296-1008_4e183e42-57b7-562e-e054-00144ff88e88 67296-1008 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100730 NDA NDA018851 RedPharm Drug, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1021_4e2c0893-6fb0-15ed-e054-00144ff8d46c 67296-1021 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 RedPharm Drug, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 67296-1032_4e2cd6ec-edac-1f45-e054-00144ff88e88 67296-1032 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA088832 RedPharm Drug, Inc. PREDNISONE 10 mg/1 N 20181231 67296-1034_4e2d06ed-7b30-26d5-e054-00144ff88e88 67296-1034 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20060313 ANDA ANDA077309 RedPharm Drug, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 67296-1039_4e2d33d8-84ae-2abd-e054-00144ff88e88 67296-1039 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19990226 ANDA ANDA040230 RedPharm Drug, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 67296-1040_4e3c2507-3f3f-39a5-e054-00144ff8d46c 67296-1040 HUMAN PRESCRIPTION DRUG oxycodone hydrochloride oxycodone hydrochloride TABLET ORAL 20090512 ANDA ANDA090659 RedPharm Drug, Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-1049_4e3d52bb-cd04-550c-e054-00144ff88e88 67296-1049 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 RedPharm Drug, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67296-1050_4e3f0f1d-68ca-5313-e054-00144ff8d46c 67296-1050 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 RedPharm Drug, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 67296-1053_4e400aef-05d1-2aea-e054-00144ff88e88 67296-1053 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate Terbutaline Sulfate TABLET ORAL 20050325 ANDA ANDA077152 RedPharm Drug, Inc. TERBUTALINE SULFATE 2.5 mg/1 N 20181231 67296-1054_4e403fe2-731e-3453-e054-00144ff88e88 67296-1054 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970423 ANDA ANDA074556 RedPharm Drug, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 67296-1060_4e409ad8-0091-1fe1-e054-00144ff8d46c 67296-1060 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20060510 ANDA ANDA077754 RedPharm Drug, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-1064_4e4112f6-0c9b-26d7-e054-00144ff8d46c 67296-1064 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20101231 ANDA ANDA090066 RedPharm Drug, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1072_4e79245f-ecfe-04c4-e054-00144ff88e88 67296-1072 HUMAN PRESCRIPTION DRUG clarithromycin clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080101 ANDA ANDA065145 RedPharm Drug, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 67296-1081_4e7994f0-95a2-039c-e054-00144ff8d46c 67296-1081 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone HCl TABLET ORAL 20010328 ANDA ANDA074253 RedPharm Drug, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 67296-1089_4e7965f2-09bb-6f9a-e054-00144ff8d46c 67296-1089 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 RedPharm Drug, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 67296-1090_4e7abd81-c6bc-360d-e054-00144ff88e88 67296-1090 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 19830428 ANDA ANDA088238 RedPharm Drug, Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67296-1094_4e7af293-8d6f-41b0-e054-00144ff8d46c 67296-1094 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 19930923 ANDA ANDA073449 RedPharm Drug, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67296-1097_4e7bef83-aa64-3a6b-e054-00144ff88e88 67296-1097 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076558 RedPharm Drug, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 67296-1107_4e8f0587-58de-6d6e-e054-00144ff88e88 67296-1107 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100710 NDA NDA018851 RedPharm Drug, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1119_4ea3cb49-c27a-3cac-e054-00144ff88e88 67296-1119 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 RedPharm Drug, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 67296-1120_4ea41402-f086-45ac-e054-00144ff88e88 67296-1120 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 RedPharm Drug, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 67296-1123_4ea466dd-62cd-6ba1-e054-00144ff8d46c 67296-1123 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 RedPharm Drug, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 67296-1126_4ea4ab20-93f7-57c2-e054-00144ff88e88 67296-1126 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 RedPharm Drug, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67296-1127_4ea50299-3a54-6100-e054-00144ff88e88 67296-1127 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140909 ANDA ANDA063083 RedPharm Drug, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 67296-1129_4eb60cd1-612d-20ab-e054-00144ff88e88 67296-1129 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20100608 ANDA ANDA091348 RedPharm Drug, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 67296-1135_4eb684e5-4b9e-3065-e054-00144ff88e88 67296-1135 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 RedPharm Drug, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67296-1142_4eb684e5-4baf-3065-e054-00144ff88e88 67296-1142 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 RedPharm Drug, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67296-1143_4eb6db6a-3497-378c-e054-00144ff8d46c 67296-1143 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 RedPharm Drug, Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67296-1154_4eb78a06-0be4-5aad-e054-00144ff8d46c 67296-1154 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA076059 RedPharm Drug, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 67296-1155_4eb7d5cc-b130-67e2-e054-00144ff8d46c 67296-1155 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 RedPharm Drug, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67296-1156_4eb83e73-9dbb-07ae-e054-00144ff8d46c 67296-1156 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 RedPharm Drug, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67296-1163_4eb8dbf3-616d-0bbf-e054-00144ff88e88 67296-1163 HUMAN PRESCRIPTION DRUG SULFATRIM SULFATRIM SUSPENSION ORAL 19830701 NDA NDA018615 RedPharm Drug, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 67296-1164_4eb90616-2f6e-3c48-e054-00144ff8d46c 67296-1164 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 19951130 ANDA ANDA064071 RedPharm Drug, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67296-1174_4eb930ca-8dc4-38ba-e054-00144ff8d46c 67296-1174 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 RedPharm Drug, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67296-1175_4eb9441b-27bb-1b8f-e054-00144ff88e88 67296-1175 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20111107 ANDA ANDA074625 RedPharm Drug, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 67296-1176_4ec9b358-f3d8-3eb5-e054-00144ff88e88 67296-1176 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, COATED ORAL 20110802 UNAPPROVED DRUG OTHER RedPharm Drug, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 67296-1180_4ec8c25f-a8c4-63da-e054-00144ff8d46c 67296-1180 HUMAN PRESCRIPTION DRUG Cefprozil Cefprozil TABLET, FILM COATED ORAL 20070524 ANDA ANDA065340 RedPharm Drug, Inc. CEFPROZIL 500 mg/1 N 20181231 67296-1181_4eca4036-ba55-408e-e054-00144ff8d46c 67296-1181 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063065 RedPharm Drug, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 67296-1185_5c50afc5-12fc-86f5-e053-2a91aa0a350b 67296-1185 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 RedPharm Drug, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 67296-1186_4ecb4847-c7d7-6ef3-e054-00144ff8d46c 67296-1186 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 RedPharm Drug, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67296-1194_4ecb7106-afc0-01a7-e054-00144ff8d46c 67296-1194 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20030314 ANDA ANDA084283 RedPharm Drug, Inc. PREDNISONE 50 mg/1 N 20181231 67296-1196_4ecb7bdc-4a47-7444-e054-00144ff88e88 67296-1196 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 RedPharm Drug, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 67296-1198_4ecc3a7a-971e-2572-e054-00144ff8d46c 67296-1198 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20080131 ANDA ANDA078619 RedPharm Drug, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67296-1199_4ecc3a7a-972b-2572-e054-00144ff8d46c 67296-1199 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 RedPharm Drug, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67296-1200_4ecd48c4-482b-5681-e054-00144ff8d46c 67296-1200 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130319 ANDA ANDA202389 RedPharm Drug, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67296-1201_52a4945b-7347-484c-e054-00144ff88e88 67296-1201 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 RedPharm Drug, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67296-1202_4f08cfc9-7afd-33aa-e054-00144ff88e88 67296-1202 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20111101 ANDA ANDA076164 RedPharm Drug, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 67296-1203_5205a8a3-e081-65d9-e054-00144ff88e88 67296-1203 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 19871101 ANDA ANDA080356 RedPharm Drug, Inc. PREDNISONE 5 mg/1 N 20181231 67296-1205_4f0941aa-8497-10d1-e054-00144ff8d46c 67296-1205 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 19710401 ANDA ANDA061454 RedPharm Drug, Inc. DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67296-1206_4f0a28d3-eeaf-3f4d-e054-00144ff8d46c 67296-1206 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 RedPharm Drug, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 67296-1208_4f1e0ef0-566a-0cb8-e054-00144ff88e88 67296-1208 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 RedPharm Drug, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67296-1210_4f1bbc1d-9586-20b2-e054-00144ff88e88 67296-1210 HUMAN PRESCRIPTION DRUG Lomotil Lomotil TABLET ORAL 19600915 NDA NDA012462 RedPharm Drug, Inc. ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025; 2.5 mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Antidiarrheal [EPC] CV N 20181231 67296-1211_527eeb33-2890-22f3-e054-00144ff88e88 67296-1211 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20150602 ANDA ANDA062713 RedPharm Drug, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67296-1216_4f1be4f6-9fb3-5c19-e054-00144ff8d46c 67296-1216 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107 ANDA ANDA065434 RedPharm Drug, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67296-1217_4f1d5117-243e-2cae-e054-00144ff8d46c 67296-1217 HUMAN PRESCRIPTION DRUG IBU IBU TABLET ORAL 20081120 ANDA ANDA075682 RedPharm Drug, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1219_4f2d72eb-339f-12b1-e054-00144ff88e88 67296-1219 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 19970430 ANDA ANDA074556 RedPharm Drug, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 67296-1222_4f2dd884-42c2-0c29-e054-00144ff8d46c 67296-1222 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 RedPharm Drug, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 67296-1225_4f2e74ef-9237-2dcb-e054-00144ff8d46c 67296-1225 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 RedPharm Drug, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1228_4f30bfb6-88fd-2b2d-e054-00144ff8d46c 67296-1228 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 RedPharm Drug, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-1230_5205ff55-e7ab-01ac-e054-00144ff8d46c 67296-1230 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 RedPharm Drug, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 67296-1232_4f30e131-a11e-042a-e054-00144ff88e88 67296-1232 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140501 ANDA ANDA065330 RedPharm Drug, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67296-1233_4f30f9f6-d85e-06a3-e054-00144ff88e88 67296-1233 HUMAN PRESCRIPTION DRUG PHENAZOPYRIDINE HYDROCHLORIDE PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20110818 UNAPPROVED DRUG OTHER RedPharm Drug, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 67296-1234_4f314d1a-237b-464f-e054-00144ff8d46c 67296-1234 HUMAN PRESCRIPTION DRUG Norvir Norvir TABLET, FILM COATED ORAL 20100506 NDA NDA022417 RedPharm Drug, Inc. RITONAVIR 100 mg/1 UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 67296-1235_4f31df66-7dc8-1f04-e054-00144ff88e88 67296-1235 HUMAN PRESCRIPTION DRUG ISENTRESS ISENTRESS TABLET, FILM COATED ORAL 20071012 NDA NDA022145 RedPharm Drug, Inc. RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] N 20181231 67296-1236_4f424439-c80a-22fc-e054-00144ff8d46c 67296-1236 HUMAN PRESCRIPTION DRUG REYATAZ REYATAZ CAPSULE, GELATIN COATED ORAL 20030624 NDA NDA021567 RedPharm Drug, Inc. ATAZANAVIR SULFATE 300 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 67296-1237_4f4268c2-42ab-49fa-e054-00144ff88e88 67296-1237 HUMAN PRESCRIPTION DRUG Truvada Truvada TABLET, FILM COATED ORAL 20040802 NDA NDA021752 RedPharm Drug, Inc. EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 67296-1238_4f42bbd5-9b63-3ec9-e054-00144ff8d46c 67296-1238 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 RedPharm Drug, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 10 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 67296-1240_4f43889f-3e6b-6a5c-e054-00144ff8d46c 67296-1240 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20090811 ANDA ANDA072781 RedPharm Drug, Inc. NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67296-1241_4f457a86-b921-5b53-e054-00144ff8d46c 67296-1241 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20130227 NDA AUTHORIZED GENERIC NDA012462 RedPharm Drug, Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 67296-1242_4f4601c8-37f1-4ecc-e054-00144ff88e88 67296-1242 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20151123 UNAPPROVED DRUG OTHER RedPharm Drug, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 67296-1243_520680bd-a1e5-16d7-e054-00144ff8d46c 67296-1243 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090120 RedPharm Drug, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 67296-1245_52564987-e1c9-617f-e054-00144ff8d46c 67296-1245 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19780410 ANDA ANDA086009 RedPharm Drug, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67296-1246_525698da-7eb5-6fbd-e054-00144ff8d46c 67296-1246 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 RedPharm Drug, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 67296-1247_4f463a8e-20cf-5674-e054-00144ff88e88 67296-1247 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 RedPharm Drug, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 67296-1248_4f96d083-06a8-3655-e054-00144ff8d46c 67296-1248 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 RedPharm Drug, Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67296-1249_4f972bfd-fdfb-20a1-e054-00144ff88e88 67296-1249 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20111101 ANDA ANDA076180 RedPharm Drug, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 67296-1250_525711af-c859-28bf-e054-00144ff88e88 67296-1250 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20061002 ANDA ANDA078008 RedPharm Drug, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1251_5268708d-7710-0a29-e054-00144ff88e88 67296-1251 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20061212 ANDA ANDA040621 RedPharm Drug, Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 67296-1252_4fa706cc-56e8-1ed0-e054-00144ff8d46c 67296-1252 HUMAN OTC DRUG Rugby Rugby TABLET ORAL 20140307 OTC MONOGRAPH FINAL part336 RedPharm Drug, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 67296-1264_4fa716c7-d6f0-2217-e054-00144ff8d46c 67296-1264 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20041220 ANDA ANDA075317 RedPharm Drug, Inc. TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67296-1265_4fa7df0b-78ef-4bad-e054-00144ff8d46c 67296-1265 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018832 RedPharm Drug, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 67296-1266_5267ccbb-db19-5124-e054-00144ff8d46c 67296-1266 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19920701 ANDA ANDA073555 RedPharm Drug, Inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67296-1267_4fa7948f-5099-3aa6-e054-00144ff8d46c 67296-1267 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20110718 ANDA ANDA074550 RedPharm Drug, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 67296-1268_52694707-d0b0-26bd-e054-00144ff88e88 67296-1268 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 RedPharm Drug, Inc. HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE 6.25; 2.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67296-1269_4fa9482a-ee89-1afd-e054-00144ff8d46c 67296-1269 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 RedPharm Drug, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 67296-1270_52a5d72e-a361-7259-e054-00144ff8d46c 67296-1270 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 RedPharm Drug, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67296-1271_526a2ad8-547d-480f-e054-00144ff88e88 67296-1271 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20150201 ANDA ANDA075126 RedPharm Drug, Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1272_4faa1082-85f2-414a-e054-00144ff8d46c 67296-1272 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20100621 ANDA ANDA070218 RedPharm Drug, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67296-1273_4faa7ea7-21f9-56b9-e054-00144ff8d46c 67296-1273 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20100621 ANDA ANDA070219 RedPharm Drug, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67296-1274_526af013-5fd6-5f4c-e054-00144ff88e88 67296-1274 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 RedPharm Drug, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67296-1275_4faadbea-8915-6914-e054-00144ff8d46c 67296-1275 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20100331 ANDA ANDA040445 RedPharm Drug, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 67296-1277_4faaebf0-0d74-6775-e054-00144ff8d46c 67296-1277 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 RedPharm Drug, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-1278_526b43ee-0246-1d9b-e054-00144ff8d46c 67296-1278 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20141124 ANDA ANDA070044 RedPharm Drug, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 67296-1279_527e2795-b9bf-6d97-e054-00144ff8d46c 67296-1279 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 RedPharm Drug, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67296-1280_4fbacd52-ae58-208b-e054-00144ff8d46c 67296-1280 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate SL Hyoscyamine Sulfate SL TABLET ORAL 20110904 UNAPPROVED DRUG OTHER RedPharm Drug, Inc. HYOSCYAMINE SULFATE .125 mg/1 N 20181231 67296-1282_4fbc673b-546b-4845-e054-00144ff88e88 67296-1282 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED ORAL 20040401 ANDA ANDA076604 RedPharm Drug, Inc. HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 67296-1283_4fbe2b3f-4c70-43b7-e054-00144ff8d46c 67296-1283 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 RedPharm Drug, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 67296-1284_52a2b437-1643-6e14-e054-00144ff88e88 67296-1284 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150714 ANDA ANDA040616 RedPharm Drug, Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 67296-1285_52a408dc-3768-20dd-e054-00144ff8d46c 67296-1285 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20100816 ANDA ANDA202202 RedPharm Drug, Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 67296-1288_4fbea9e7-60bb-1e82-e054-00144ff88e88 67296-1288 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 RedPharm Drug, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67296-1289_4fcf1f87-7727-1cbb-e054-00144ff88e88 67296-1289 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 RedPharm Drug, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67296-1290_4fbeb8e2-7226-5cfb-e054-00144ff8d46c 67296-1290 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20150810 ANDA ANDA202765 RedPharm Drug, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67296-1291_4fbf31a1-037a-31a2-e054-00144ff88e88 67296-1291 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140704 ANDA ANDA065418 RedPharm Drug, Inc. CEFDINIR MONOHYDRATE 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67296-1292_4fcf1f87-772c-1cbb-e054-00144ff88e88 67296-1292 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20080118 ANDA ANDA065248 RedPharm Drug, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67296-1293_4fbf72e0-c7eb-0a50-e054-00144ff8d46c 67296-1293 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 RedPharm Drug, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 67296-1294_4fcfc585-78df-2dce-e054-00144ff88e88 67296-1294 HUMAN PRESCRIPTION DRUG ondansetron ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 RedPharm Drug, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 67296-1295_4fd00f25-026c-3ced-e054-00144ff88e88 67296-1295 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl 100mg Phenazopyridine HCl 100mg TABLET ORAL 20141231 UNAPPROVED DRUG OTHER RedPharm Drug, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 67296-1296_4fd0b243-742d-50a4-e054-00144ff88e88 67296-1296 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl 200mg Phenazopyridine HCl 200mg TABLET ORAL 20141231 UNAPPROVED DRUG OTHER RedPharm Drug, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 67296-1299_4fd26bda-2ebb-1730-e054-00144ff88e88 67296-1299 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET, FILM COATED ORAL 20140129 NDA AUTHORIZED GENERIC NDA021085 RedPharm Drug, Inc. MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 67296-1300_4fd2fd45-e5a5-291a-e054-00144ff88e88 67296-1300 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 RedPharm Drug, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 67296-1301_4fe2cf36-625e-12ef-e054-00144ff88e88 67296-1301 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 19960730 ANDA ANDA040105 RedPharm Drug, Inc, OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-1303_4fe37efa-9f80-4f03-e054-00144ff8d46c 67296-1303 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20120723 ANDA ANDA074215 RedPharm Drug, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-1304_4fe3c273-eb46-331c-e054-00144ff88e88 67296-1304 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19991103 ANDA ANDA040317 RedPharm Drug, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 67296-1309_4fe3c273-eb85-331c-e054-00144ff88e88 67296-1309 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 RedPharm Drug, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 67296-1313_4fe41c62-a6ca-3e91-e054-00144ff88e88 67296-1313 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20120723 ANDA ANDA074215 RedPharm Drug, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-1314_4fe4f58d-975e-1f7d-e054-00144ff8d46c 67296-1314 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20030627 ANDA ANDA075798 RedPharm Drug, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 67296-1315_4fe525d1-f854-614e-e054-00144ff88e88 67296-1315 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20160314 ANDA ANDA063029 RedPharm Drug, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 67296-1316_4fe592cf-b5ad-3d3c-e054-00144ff8d46c 67296-1316 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19980811 ANDA ANDA075219 RedPharm Drug, Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1317_4fe5e10f-f3a7-0201-e054-00144ff88e88 67296-1317 HUMAN PRESCRIPTION DRUG MELOXICAM MELOXICAM TABLET ORAL 20060719 ANDA ANDA077929 RedPharm Drug, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1318_4fe686e7-b9bc-7450-e054-00144ff8d46c 67296-1318 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 RedPharm Drug, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 67296-1319_4fe6f814-a879-1247-e054-00144ff8d46c 67296-1319 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 RedPharm Drug, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67296-1320_50213d90-cdd9-7267-e054-00144ff8d46c 67296-1320 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20160201 ANDA ANDA062058 RedPharm Drug, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67296-1324_5021a19a-508a-0161-e054-00144ff88e88 67296-1324 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20150617 ANDA ANDA206456 RedPharm Drug, Inc. OXYCODONE HYDROCHLORIDE 5 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-1325_50224ecd-8873-177e-e054-00144ff88e88 67296-1325 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA076710 RedPharm Drug, Inc. LEVOFLOXACIN 250 mg/1 N 20181231 67296-1326_502297e7-8e93-3315-e054-00144ff8d46c 67296-1326 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 RedPharm Drug, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67296-1327_505ee941-2963-35e4-e054-00144ff88e88 67296-1327 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 RedPharm Drug, Inc. TRIMETHOPRIM; SULFAMETHOXAZOLE 160; 800 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 67296-1329_502297e7-8ece-3315-e054-00144ff8d46c 67296-1329 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET ORAL 20150522 ANDA ANDA091498 RedPharm Drug, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 67296-1332_50235b15-a346-713f-e054-00144ff8d46c 67296-1332 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 RedPharm Drug, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-1333_5d6b81ea-9c3a-adcf-e053-2991aa0acf74 67296-1333 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160412 ANDA ANDA202991 RedPharm Drug, Inc. ACETAMINOPHEN; HYDROCODONE BITARTRATE 325; 5 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 67296-1334_5023c851-d258-48f1-e054-00144ff88e88 67296-1334 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160412 ANDA ANDA202991 RedPharm Drug, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 67296-1335_503457f0-7e84-56c8-e054-00144ff88e88 67296-1335 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160412 ANDA ANDA202991 RedPharm Drug, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 67296-1336_5035d2a2-8388-118d-e054-00144ff88e88 67296-1336 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20120327 ANDA ANDA090749 RedPharm Drug, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 67296-1339_50361fc8-8fbd-1c45-e054-00144ff88e88 67296-1339 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20160414 ANDA ANDA090796 RedPharm Drug, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1343_5036946e-7b6f-27c4-e054-00144ff88e88 67296-1343 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 RedPharm Drug, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67296-1345_5036e5b2-ac46-331e-e054-00144ff88e88 67296-1345 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20150923 ANDA ANDA207446 RedPharm Drug, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1349_50377b7a-6fb5-43f2-e054-00144ff8d46c 67296-1349 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071135 RedPharm Drug, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-1350_5037bdfc-a382-533a-e054-00144ff88e88 67296-1350 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20110818 UNAPPROVED DRUG OTHER RedPharm Drug, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 67296-1351_5045f807-4f09-7436-e054-00144ff88e88 67296-1351 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 RedPharm Drug, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 67296-1360_5047246b-3110-5ae0-e054-00144ff8d46c 67296-1360 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20151204 ANDA ANDA203584 RedPharm Drug, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 67296-1361_50473cd2-fda1-5ea1-e054-00144ff8d46c 67296-1361 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20150601 ANDA ANDA081297 RedPharm Drug, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67296-1362_50477654-1fe6-3898-e054-00144ff88e88 67296-1362 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20150602 ANDA ANDA062713 RedPharm Drug, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67296-1366_50486587-8f8f-1f9e-e054-00144ff8d46c 67296-1366 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150529 ANDA ANDA203974 RedPharm Drug, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 67296-1367_5048b657-38e5-22f7-e054-00144ff8d46c 67296-1367 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150819 ANDA ANDA203270 RedPharm Drug, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 67296-1368_50490db4-9729-6d7e-e054-00144ff88e88 67296-1368 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20140414 ANDA ANDA204234 RedPharm Drug, Inc. DOXYCYCLINE 100 mg/1 N 20181231 67296-1371_50497c81-882b-0707-e054-00144ff88e88 67296-1371 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20150601 ANDA ANDA081297 RedPharm Drug, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67296-1374_5049de40-86e4-628b-e054-00144ff8d46c 67296-1374 HUMAN PRESCRIPTION DRUG naproxen naproxen TABLET ORAL 20160705 ANDA ANDA091305 RedPharm Drug, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1375_504a340d-2bf9-70b9-e054-00144ff8d46c 67296-1375 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151026 ANDA ANDA203849 RedPharm Drug, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-1376_504aa63a-4773-2e03-e054-00144ff88e88 67296-1376 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160222 NDA AUTHORIZED GENERIC NDA022272 RedPharm Drug, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-1377_5c3d14ab-4f6f-6cec-e053-2a91aa0a3c09 67296-1377 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160630 ANDA ANDA040746 RedPharm Drug, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 67296-1379_504ba5ad-0a51-4f85-e054-00144ff88e88 67296-1379 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 RedPharm Drug, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-1380_504c0f1c-b0ce-4aae-e054-00144ff8d46c 67296-1380 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 RedPharm Drug, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67296-1383_50597369-cb09-5a5b-e054-00144ff88e88 67296-1383 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 RedPharm Drug, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 67296-1385_57e7cf31-0a75-d8da-e053-2a91aa0af67d 67296-1385 HUMAN PRESCRIPTION DRUG doxycycline doxycycline CAPSULE ORAL 20160314 ANDA ANDA205115 RedPharm Drug, Inc. DOXYCYCLINE 100 mg/1 N 20181231 67296-1389_505d0a1e-6cfe-6b9d-e054-00144ff88e88 67296-1389 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20070426 ANDA ANDA077859 RedPharm Drug, Inc. CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 67296-1390_505f6036-d217-4455-e054-00144ff88e88 67296-1390 HUMAN OTC DRUG Meclizine HCl 25 mg Meclizine HCl 25 mg TABLET, CHEWABLE ORAL 20151015 OTC MONOGRAPH FINAL part336 RedPharm Drug, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 67296-1392_50732645-a9eb-3bef-e054-00144ff8d46c 67296-1392 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20161201 ANDA ANDA201972 RedPharm Drug, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-1393_50732645-aa08-3bef-e054-00144ff8d46c 67296-1393 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150109 ANDA ANDA202801 RedPharm Drug, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 67296-1394_50c2220b-558f-6b73-e054-00144ff8d46c 67296-1394 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 RedPharm Drug, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 67296-1396_50c28fda-7d65-08ce-e054-00144ff8d46c 67296-1396 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 RedPharm Drug, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67296-1400_50c45523-1faf-4b26-e054-00144ff88e88 67296-1400 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150109 ANDA ANDA202801 RedPharm Drug, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 67296-1401_50d3a17f-34ee-219f-e054-00144ff88e88 67296-1401 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 RedPharm Drug, Inc. ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325; 5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-1402_50d3fab5-36e1-46a8-e054-00144ff8d46c 67296-1402 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20151007 ANDA ANDA205702 RedPharm Drug, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 67296-1403_50d3dfb4-c67a-1a3f-e054-00144ff88e88 67296-1403 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20130201 ANDA ANDA203253 RedPharm Drug, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 67296-1404_50d4d542-d0c0-40cd-e054-00144ff88e88 67296-1404 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20140731 ANDA ANDA203374 RedPharm Drug, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 67296-1405_50d5094e-07fa-5162-e054-00144ff88e88 67296-1405 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19961118 ANDA ANDA040185 RedPharm Drug, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 67296-1505_50d651cc-e418-3b40-e054-00144ff8d46c 67296-1505 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20050425 ANDA ANDA076913 RedPharm Drug, Inc. PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67296-1507_50d70f26-662b-1ea2-e054-00144ff88e88 67296-1507 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20090826 ANDA ANDA065442 RedPharm Drug, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 67296-1508_50d7863f-fbba-7330-e054-00144ff8d46c 67296-1508 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20070720 ANDA ANDA040780 RedPharm Drug, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67296-1509_50d7ed6a-ef45-593d-e054-00144ff8d46c 67296-1509 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 RedPharm Drug, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67296-1512_51791389-b863-4793-e054-00144ff88e88 67296-1512 HUMAN PRESCRIPTION DRUG indomethacin indomethacin CAPSULE ORAL 20160721 ANDA ANDA090403 RedPharm Drug, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1516_5c3c7fb4-36a1-43d3-e053-2a91aa0a0a0d 67296-1516 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170105 ANDA ANDA202800 RedPharm Drug, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 67296-1520_5179a29b-e8c0-6677-e054-00144ff88e88 67296-1520 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 RedPharm Drug, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 67296-1521_51f1a9ee-a926-3bde-e054-00144ff88e88 67296-1521 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 RedPharm Drug, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1522_5178907d-3696-3666-e054-00144ff88e88 67296-1522 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20080317 NDA NDA022207 RedPharm Drug, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-1524_598f01a6-e667-c3e6-e053-2991aa0adc43 67296-1524 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20170330 ANDA ANDA077797 RedPharm Drug, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67296-1525_52a2ac94-f8ba-35fb-e054-00144ff8d46c 67296-1525 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20111101 ANDA ANDA091240 RedPharm Drug, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67296-1527_56cfd673-6595-5292-e054-00144ff8d46c 67296-1527 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 RedPharm Drug, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67296-1528_56cf0d87-f81b-309e-e054-00144ff8d46c 67296-1528 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 RedPharm Drug, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67296-1529_56d031db-67ee-217d-e054-00144ff88e88 67296-1529 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 RedPharm Drug, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67296-1530_56d0ae2b-6d94-02b6-e054-00144ff8d46c 67296-1530 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20101020 ANDA ANDA078925 RedPharm Drug, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67296-1531_5c4ef6f5-e956-42db-e053-2a91aa0a67e6 67296-1531 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20170411 ANDA ANDA207419 RedPharm Drug, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-1532_57e9cb6c-4719-7821-e053-2991aa0afa6b 67296-1532 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 RedPharm Drug, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 67296-1534_57e8a74c-853c-40cf-e053-2a91aa0a4452 67296-1534 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20170330 ANDA ANDA077797 RedPharm Drug, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67296-1535_56ce8e3a-40f4-1bc1-e054-00144ff8d46c 67296-1535 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 RedPharm Drug LEVOFLOXACIN 250 mg/1 N 20181231 67296-1536_570b880f-f51a-22b3-e054-00144ff8d46c 67296-1536 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 RedPharm Drug, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67296-1539_570a7564-2250-6009-e054-00144ff8d46c 67296-1539 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070104 ANDA ANDA071404 RedPharm Drug, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-1540_570b0ecf-0569-3bb0-e054-00144ff88e88 67296-1540 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20070103 ANDA ANDA071403 RedPharm Drug, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67296-1542_57ea4bd2-d4be-4394-e053-2991aa0a2bb4 67296-1542 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20140901 ANDA ANDA040400 RedPharm Drug, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 67296-1543_57eab132-77fd-4282-e053-2a91aa0a2327 67296-1543 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20150201 ANDA ANDA075090 RedPharm Drug, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 67296-1546_5c4fc2b1-c7c5-8aa9-e053-2991aa0a34e0 67296-1546 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 RedPharm Drug, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 67296-1549_59900776-1821-3f2a-e053-2a91aa0aa9e3 67296-1549 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070409 ANDA ANDA040597 RedPharm Drug, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67296-1552_5c51042b-892d-f688-e053-2a91aa0a44d9 67296-1552 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 RedPharm Drug, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 67296-1557_5bfdc526-5e21-ba08-e053-2991aa0a4520 67296-1557 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160930 ANDA ANDA204989 RedPharm Drug, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67296-1558_5c4dded6-dd64-1d2b-e053-2a91aa0a779f 67296-1558 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 RedPharm Drug, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67296-1560_603e7601-7e11-3821-e053-2a91aa0a2287 67296-1560 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151012 NDA NDA022272 RedPharm Drug, Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-1561_5bfee7cd-a243-3119-e053-2991aa0ab355 67296-1561 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110114 ANDA ANDA074862 RedPharm Drug, Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67296-1566_603f3461-b483-ad3e-e053-2a91aa0aab86 67296-1566 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040627 RedPharm Drug, INc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67303-501_a0965ef4-74e4-49ae-b4f3-0d49f78b5b3d 67303-501 HUMAN OTC DRUG SmileActives Pro Whitening Fluoride PASTE, DENTIFRICE DENTAL 20140128 OTC MONOGRAPH NOT FINAL part356 Oraceutical SODIUM FLUORIDE .24 g/100g N 20181231 67308-101_d97f7ec9-ab70-4556-9c86-97157f1d9434 67308-101 HUMAN PRESCRIPTION DRUG LEVULAN KERASTICK aminolevulinic acid hydrochloride KIT 20000904 NDA NDA020965 DUSA Pharmaceuticals, Inc. N 20181231 67318-001_409e00d3-2fa6-49fa-a72f-8b9725cdb1ce 67318-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Tru-Care Medical, Inc. OXYGEN 99 L/100L E 20171231 67326-350_4180d9fc-bbde-6790-e054-00144ff8d46c 67326-350 HUMAN OTC DRUG Prep Solution Topical Antiseptic Microbicide POVIDONE-IODINE SOLUTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Degasa SA De CV POVIDONE-IODINE 100 mg/mL N 20181231 67326-351_418326bc-9433-63ba-e054-00144ff8d46c 67326-351 HUMAN OTC DRUG Surgical Scrub Skin Cleanser POVIDONE-IODINE SOLUTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part333E Degasa SA De CV POVIDONE-IODINE 75 mg/mL N 20181231 67326-352_251a07cc-b037-491a-b091-54545a3684d0 67326-352 HUMAN OTC DRUG Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub POVIDONE-IODINE SOLUTION TOPICAL 20150813 OTC MONOGRAPH NOT FINAL part333E Degasa SA De CV POVIDONE-IODINE 75 mg/mL N 20181231 67334-0457_0222affc-11d3-4ef6-ab5c-d1a9a566bfba 67334-0457 STANDARDIZED ALLERGENIC T.R.U.E. Test Thin-Layer Rapid Use Patch Test Standardized Allergenic KIT 20120301 BLA BLA103738 SmartPractice Denmark ApS N 20181231 67345-0001_03ffb5a5-ba6b-4c4c-8e76-9fa6db458b77 67345-0001 HUMAN OTC DRUG Purminerals 4-in-1 Mineral Tinted Moisturizer Broad Spectrum SPF 20 (LIGHT) Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Purminerals TITANIUM DIOXIDE; ZINC OXIDE 5; 5 g/100g; g/100g N 20181231 67345-0002_03ffb5a5-ba6b-4c4c-8e76-9fa6db458b77 67345-0002 HUMAN OTC DRUG Purminerals 4-in-1 Mineral Tinted Moisturizer Broad Spectrum SPF 20 (MEDIUM) Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Purminerals TITANIUM DIOXIDE; ZINC OXIDE 5; 5 g/100g; g/100g N 20181231 67345-0003_03ffb5a5-ba6b-4c4c-8e76-9fa6db458b77 67345-0003 HUMAN OTC DRUG Purminerals 4-in-1 Mineral Tinted Moisturizer Broad Spectrum SPF 20 (TAN) Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Purminerals TITANIUM DIOXIDE; ZINC OXIDE 5; 5 g/100g; g/100g N 20181231 67345-0004_03ffb5a5-ba6b-4c4c-8e76-9fa6db458b77 67345-0004 HUMAN OTC DRUG Purminerals 4-in-1 Mineral Tinted Moisturizer Broad Spectrum SPF 20 (DARK) Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part352 Purminerals TITANIUM DIOXIDE; ZINC OXIDE 5; 5 g/100g; g/100g N 20181231 67345-0005_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0005 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (LIGHT) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL N 20181231 67345-0006_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0006 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (BLUSH MEDIUM) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL N 20181231 67345-0007_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0007 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (GOLDEN MEDIUM) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL N 20181231 67345-0008_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0008 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (LIGHT TAN) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL N 20181231 67345-0009_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0009 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (TAN) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL N 20181231 67345-0010_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0010 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (MEDIUM DARK) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL N 20181231 67345-0011_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0011 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (GOLDEN DARK) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL N 20181231 67345-0012_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0012 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (DEEP) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL N 20181231 67345-0013_c8d2ee31-f3ff-4418-bb6c-f2d3380cac0a 67345-0013 HUMAN OTC DRUG Purminerals 4-in-1 14-Hour Wear Foundation Broad Spectrum SPF 15 (DEEPER) Octinoxate LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Purminerals OCTINOXATE 50 mg/mL N 20181231 67345-0014_c89206b7-4457-47c8-9bfc-6de82d26c875 67345-0014 HUMAN OTC DRUG Pur Air Perfection CC Cushion Foundation Broad Spectrum SPF 50 Plus (LIGHT) Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 Purminerals TITANIUM DIOXIDE; ZINC OXIDE 63; 63 mg/mL; mg/mL N 20181231 67345-0015_c89206b7-4457-47c8-9bfc-6de82d26c875 67345-0015 HUMAN OTC DRUG Pur Air Perfection CC Cushion Foundation Broad Spectrum SPF 50 Plus (MEDIUM) Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 Purminerals TITANIUM DIOXIDE; ZINC OXIDE 63; 63 mg/mL; mg/mL N 20181231 67345-0016_c89206b7-4457-47c8-9bfc-6de82d26c875 67345-0016 HUMAN OTC DRUG Pur Air Perfection CC Cushion Foundation Broad Spectrum SPF 50 Plus (TAN) Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 Purminerals TITANIUM DIOXIDE; ZINC OXIDE 63; 63 mg/mL; mg/mL N 20181231 67345-0017_c89206b7-4457-47c8-9bfc-6de82d26c875 67345-0017 HUMAN OTC DRUG Pur Air Perfection CC Cushion Foundation Broad Spectrum SPF 50 Plus (DARK) Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 Purminerals TITANIUM DIOXIDE; ZINC OXIDE 63; 63 mg/mL; mg/mL N 20181231 67345-0509_529bac52-8605-4e20-8490-3c4577f63dd7 67345-0509 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Porcelain Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-0510_8e5953f8-367c-4ab8-aae8-3743338fbae4 67345-0510 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Light Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PURMINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-0511_a7a9f744-970e-401f-8958-01bf3ba10646 67345-0511 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Blush Medium Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-0512_34a22d13-f32d-41ee-a0e4-e0b71edda171 67345-0512 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Golden Medium Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .38 g/4.25g E 20171231 67345-0513_f783a5e5-4f99-4751-beb2-65e20697721d 67345-0513 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Tan Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PURMINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-0514_d79bb970-c0bd-41af-a970-7ce0859f419f 67345-0514 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Dark Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-0515_5cf3e82b-747a-4ea0-9b1e-9d44730f5f16 67345-0515 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Medium Dark Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-0516_1308d29d-34a4-4079-921c-0a69191c23e2 67345-0516 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Deep Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .38 g/4.25g E 20171231 67345-0517_56457907-730d-4885-bda3-a5ed85e99b46 67345-0517 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Deepest Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .38 g/4.25g E 20171231 67345-0518_3fec5ed5-6fea-43a8-9965-8cb9fe7febd5 67345-0518 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Deeper Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .38 g/4.25g E 20171231 67345-0611_e3a50694-fa40-4dc9-be4c-1bcf5b943834 67345-0611 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Light Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0631_f4dc348c-041f-4358-8a1a-fe1b53edc440 67345-0631 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Tan Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0641_6c661a83-e337-44c1-b268-8cf03677a37d 67345-0641 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Dark Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0661_1037daf6-796d-4f6f-8488-9644dbd38c17 67345-0661 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Golden Medium Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0671_03609d73-958d-42ce-a2b2-d1baaea34527 67345-0671 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Medium Dark Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0681_98de3bfe-f380-478f-b5b4-e2135413b872 67345-0681 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Deep Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0691_d7716db1-b586-47a1-8825-de06b06a4fef 67345-0691 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Deeper Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0701_f554472c-b478-4232-8a64-cc516f01bd60 67345-0701 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Deepest Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0702_6400d4c9-0f13-4250-9034-29cee8127fdb 67345-0702 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Porcelain Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0703_3b9b67c1-e612-4939-8de1-b3a94697aa7c 67345-0703 HUMAN OTC DRUG Purminerals 4 in 1 Makeup SPF 15 Blush Medium Titanium Dioxide POWDER TOPICAL 20060717 OTC MONOGRAPH NOT FINAL part352 PURMINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0780_fad4c10c-e44f-4d0b-afa3-cea163c96863 67345-0780 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Porcelain Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0781_e5d669fe-4f6d-4e3d-be9d-f8ae69e5aeea 67345-0781 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Light Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0782_5c7bc64d-ffc0-4473-aa4f-d63fbf253eec 67345-0782 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Blush Medium Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0783_e032225c-cfdd-4461-8f10-7933da6fdaf9 67345-0783 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Golden Medium Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0784_82372610-b63f-4d50-a6df-aed20e939036 67345-0784 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Light Tan Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0785_ef57a371-9fdc-4a1d-ac18-db0c426e7b7b 67345-0785 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Tan Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0786_75702240-c939-48c1-a17c-15f7a1f9310b 67345-0786 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Medium Dark Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0787_a5bb2e2e-3d96-46ff-a6cc-d94a7950c9eb 67345-0787 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Golden Dark Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0788_c34d07c4-6993-42a3-85be-34576165d619 67345-0788 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Deep Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-0789_27552de9-6555-414b-9daf-2cc1c3665efb 67345-0789 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Deeper Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .72 g/8g E 20171231 67345-6080_9d94185f-b71b-401a-9204-59efbe1200ba 67345-6080 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Golden Dark Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-6082_7295fb80-1926-446f-9ea2-96c5bf91987d 67345-6082 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Porcelain Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-6083_817215de-707e-4e7e-8f27-57be15a2d87c 67345-6083 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Light Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-6084_040d9923-42ad-415e-807d-3c0bf3ed950e 67345-6084 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Blush Medium Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-6085_768678a7-0132-4308-9a6d-545ff982c3c3 67345-6085 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Medium Dark Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-6086_10863efd-d894-4350-9507-bf95f3756caa 67345-6086 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Golden Medium Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-6087_45370c67-e4d7-4e68-96fc-cedc79aee6a8 67345-6087 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Light Tan Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67345-6088_f034a4b4-b551-4929-ba15-78e7195365d9 67345-6088 HUMAN OTC DRUG 4 in 1 Pressed Mineral SPF 15 Tan Titanium Dioxide POWDER TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part352 PUR MINERALS TITANIUM DIOXIDE .387 g/4.3g E 20171231 67361-001_6deb627a-b6bf-42b2-8b1e-7d5996313315 67361-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020801 UNAPPROVED MEDICAL GAS American Home Health Care, Inc. OXYGEN 210 mL/L E 20171231 67365-001_db0ede99-c87b-4148-a67e-34fdf24c4c90 67365-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130313 UNAPPROVED MEDICAL GAS Camelot Healthcare Management Inc. dba Suncare Respiratory Services OXYGEN 99 L/100L E 20171231 67378-001_a3db2964-5284-4598-8a8f-fb8c25f57d6d 67378-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19850101 UNAPPROVED MEDICAL GAS B-Pharm, Inc dba Remedies Medical Equipment OXYGEN 99 L/100L E 20171231 67386-111_d0c766cd-a1c9-4a91-9d94-09e3a36c7466 67386-111 HUMAN PRESCRIPTION DRUG SABRIL vigabatrin TABLET, FILM COATED ORAL 20090821 NDA NDA020427 Lundbeck Pharmaceuticals LLC VIGABATRIN 500 mg/1 Anti-epileptic Agent [EPC] N 20181231 67386-211_14bb6645-293c-4528-acad-ac9d8acd8e78 67386-211 HUMAN PRESCRIPTION DRUG SABRIL vigabatrin POWDER, FOR SOLUTION ORAL 20090821 NDA NDA022006 Lundbeck Pharmaceuticals LLC VIGABATRIN 50 mg/mL Anti-epileptic Agent [EPC] N 20181231 67386-313_58d32c2a-ca28-49cb-98f5-57cee4f42b42 67386-313 HUMAN PRESCRIPTION DRUG Onfi clobazam SUSPENSION ORAL 20121214 NDA NDA203993 Lundbeck Pharmaceuticals LLC CLOBAZAM 2.5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cytochrome P450 2D6 Inhibitors [MoA] CIV N 20181231 67386-314_58d32c2a-ca28-49cb-98f5-57cee4f42b42 67386-314 HUMAN PRESCRIPTION DRUG Onfi clobazam TABLET ORAL 20131210 NDA NDA202067 Lundbeck Pharmaceuticals LLC CLOBAZAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cytochrome P450 2D6 Inhibitors [MoA] CIV N 20181231 67386-315_58d32c2a-ca28-49cb-98f5-57cee4f42b42 67386-315 HUMAN PRESCRIPTION DRUG Onfi clobazam TABLET ORAL 20131210 NDA NDA202067 Lundbeck Pharmaceuticals LLC CLOBAZAM 20 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cytochrome P450 2D6 Inhibitors [MoA] CIV N 20181231 67386-421_0d44a6aa-b317-47ea-85b8-b33831fd9fa9 67386-421 HUMAN PRESCRIPTION DRUG Xenazine tetrabenazine TABLET ORAL 20081124 NDA NDA021894 Lundbeck Pharmaceuticals LLC TETRABENAZINE 12.5 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20181231 67386-422_0d44a6aa-b317-47ea-85b8-b33831fd9fa9 67386-422 HUMAN PRESCRIPTION DRUG Xenazine tetrabenazine TABLET ORAL 20081124 NDA NDA021894 Lundbeck Pharmaceuticals LLC TETRABENAZINE 25 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20181231 67386-621_5d69d682-23d6-4db7-981d-3131fce56746 67386-621 HUMAN PRESCRIPTION DRUG CARNEXIV Carbamazepine INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20141021 NDA NDA206030 Lundbeck Pharmaceuticals LLC CARBAMAZEPINE 10 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 67386-820_ccb12992-471d-4622-bb31-4fe70a08d4ec 67386-820 HUMAN PRESCRIPTION DRUG Northera droxidopa CAPSULE ORAL 20140901 NDA NDA203202 Lundbeck Pharmaceuticals LLC DROXIDOPA 100 mg/1 Catecholamines [Chemical/Ingredient],Increased Blood Pressure [PE] N 20181231 67386-821_ccb12992-471d-4622-bb31-4fe70a08d4ec 67386-821 HUMAN PRESCRIPTION DRUG Northera droxidopa CAPSULE ORAL 20140901 NDA NDA203202 Lundbeck Pharmaceuticals LLC DROXIDOPA 200 mg/1 Catecholamines [Chemical/Ingredient],Increased Blood Pressure [PE] N 20181231 67386-822_ccb12992-471d-4622-bb31-4fe70a08d4ec 67386-822 HUMAN PRESCRIPTION DRUG Northera droxidopa CAPSULE ORAL 20140901 NDA NDA203202 Lundbeck Pharmaceuticals LLC DROXIDOPA 300 mg/1 Catecholamines [Chemical/Ingredient],Increased Blood Pressure [PE] N 20181231 67402-021_827f05fc-94d5-4bde-8c2f-e97d250d9660 67402-021 HUMAN PRESCRIPTION DRUG NeoBenz Micro Plus Pack benzoyl peroxide KIT 20090416 UNAPPROVED DRUG OTHER SkinMedica Pharmaceuticals, Inc. E 20171231 67405-100_d16b87bc-3f19-45c9-a34d-c6b1b2d70394 67405-100 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20060823 ANDA ANDA077447 Harris Pharmaceutical, Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67405-110_a04c0094-b66a-6690-5c2f-299b10cf3131 67405-110 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole CREAM TOPICAL 20080313 ANDA ANDA077549 Harris Pharmaceutical, Inc. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 67405-275_e1c9385c-0117-c179-37c4-6a8bb1b4ce80 67405-275 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate SOLUTION TOPICAL 20140304 ANDA ANDA077678 Harris Pharmaceutical, Inc. MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67405-475_02f1de9a-fd4c-48d2-b60a-cf11629b316a 67405-475 HUMAN PRESCRIPTION DRUG Doxycycline DOXYCYCLINE POWDER, FOR SUSPENSION ORAL 20080716 ANDA ANDA065454 Harris Pharmaceutical, Inc DOXYCYCLINE 25 mg/5mL N 20181231 67405-500_fab15dcc-cd59-4598-9463-91358217eda9 67405-500 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20140813 ANDA ANDA077137 Harris Pharmaceutical, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 67405-543_6154aa0a-55b4-478b-9edd-503a96ec0dac 67405-543 HUMAN PRESCRIPTION DRUG Terbinafine Terbinafine TABLET ORAL 20070730 ANDA ANDA077919 HARRIS Pharmaceutical, Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 67405-550_ba419f8e-a752-43dc-9f36-74a90405e21f 67405-550 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 Harris Pharmaceutical, Inc DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 67405-575_48d826f3-8d20-4300-8db5-a7d7713b1308 67405-575 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 HARRIS Pharmaceutical, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 67405-577_48d826f3-8d20-4300-8db5-a7d7713b1308 67405-577 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 HARRIS Pharmaceutical, Inc. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 67405-601_d651d6e9-3a2e-438e-a532-d68ce8219de4 67405-601 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20110307 ANDA ANDA078423 Harris Pharmaceutical, Inc. FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 67405-602_d651d6e9-3a2e-438e-a532-d68ce8219de4 67405-602 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20110307 ANDA ANDA078423 Harris Pharmaceutical, Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 67405-603_d651d6e9-3a2e-438e-a532-d68ce8219de4 67405-603 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20170224 ANDA ANDA078423 Harris Pharmaceutical, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 67405-604_d651d6e9-3a2e-438e-a532-d68ce8219de4 67405-604 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20110307 ANDA ANDA078423 Harris Pharmaceutical, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 67405-650_c4cb5264-80b2-49f7-84fc-3759e93ad070 67405-650 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Harris Pharmaceutical, Inc DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 67405-651_c4cb5264-80b2-49f7-84fc-3759e93ad070 67405-651 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Harris Pharmaceutical, Inc DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 67405-660_5a766e83-4661-4f40-beb1-6fff33813574 67405-660 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 19880812 ANDA ANDA062752 Harris Pharmaceutical, Inc TETRACYCLINE HYDROCHLORIDE 250 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 67405-661_5a766e83-4661-4f40-beb1-6fff33813574 67405-661 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 19880812 ANDA ANDA062752 Harris Pharmaceutical, Inc TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 67405-671_48d826f3-8d20-4300-8db5-a7d7713b1308 67405-671 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine TABLET, FILM COATED ORAL 20070629 ANDA ANDA040808 HARRIS Pharmaceutical, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 67405-825_b1583972-8ae0-457b-9ddf-f8e61135484e 67405-825 HUMAN OTC DRUG Benzoyl Peroxide Benzoyl Peroxide LIQUID TOPICAL 20111118 OTC MONOGRAPH FINAL part333D Harris Pharmaceutical, Inc. BENZOYL PEROXIDE 50 mg/mL N 20181231 67405-830_3ee955d3-53e2-4a01-992c-084762e4bef6 67405-830 HUMAN OTC DRUG Benzoyl Peroxide Benzoyl Peroxide LIQUID TOPICAL 20111118 OTC MONOGRAPH FINAL part333D Harris Pharmaceutical, Inc. BENZOYL PEROXIDE 100 mg/mL N 20181231 67405-835_ef512c34-7112-47d4-a67b-3fe2695817ef 67405-835 HUMAN OTC DRUG Benzoyl Peroxide Benzoyl Peroxide LIQUID TOPICAL 20111118 OTC MONOGRAPH FINAL part333D Harris Pharmaceutical, Inc. BENZOYL PEROXIDE 60 mg/mL N 20181231 67414-200_639e786b-03d9-ac2d-e053-2a91aa0a9d02 67414-200 HUMAN OTC DRUG Excedrin Extra Strength Pain Reliever Acetaminophen, Aspirin (NSAID), and Caffeine TABLET, FILM COATED ORAL 20180124 OTC MONOGRAPH NOT FINAL part343 Jones Contract Packaging Services ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20191231 67414-226_639e786b-03ea-ac2d-e053-2a91aa0a9d02 67414-226 HUMAN OTC DRUG Benadryl Allergy Ultratab DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20180124 OTC MONOGRAPH FINAL part341 Jones Contract Packaging Services DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 67414-239_639e932c-52ce-d2b3-e053-2a91aa0a1ce9 67414-239 HUMAN OTC DRUG EXCEDRIN MIGRAINE Acetaminophen, Aspirin (NSAID) and Caffeine TABLET, FILM COATED ORAL 20180124 OTC MONOGRAPH NOT FINAL part343 Jones Contract Packaging Services ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20191231 67414-240_639eaff7-c257-0379-e053-2a91aa0abb50 67414-240 HUMAN OTC DRUG Motrin IB IBUPROFEN TABLET, FILM COATED ORAL 20160701 ANDA ANDA077349 Jones Contract Packaging Services IBUPROFEN 200 mg/1 N 20191231 67414-402_639eaff7-c26d-0379-e053-2a91aa0abb50 67414-402 HUMAN OTC DRUG Tylenol Cold Plus Flu Severe Severe ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20180125 OTC MONOGRAPH FINAL part341 Jones Contract Packaging Services ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20191231 67414-449_639eb6c6-ff76-0291-e053-2a91aa0a3fb3 67414-449 HUMAN OTC DRUG Tylenol Extra Strength Caplet ACETAMINOPHEN TABLET ORAL 20180124 OTC MONOGRAPH NOT FINAL part343 Jones Contract Packaging Services ACETAMINOPHEN 500 mg/1 N 20191231 67414-507_639ef98a-dae1-6b14-e053-2a91aa0a6f6b 67414-507 HUMAN OTC DRUG Tylenol Sinus Severe ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20180125 OTC MONOGRAPH FINAL part341 Jones Contract Packaging Services ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20191231 67414-608_639f4e01-9724-a619-e053-2991aa0a549a 67414-608 HUMAN OTC DRUG Tylenol PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20180125 OTC MONOGRAPH NOT FINAL part343 Jones Contract Packaging Services ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20191231 67414-719_639e537b-3803-6948-e053-2a91aa0af22c 67414-719 HUMAN PRESCRIPTION DRUG Kristalose Lactulose POWDER, FOR SOLUTION ORAL 20180124 ANDA ANDA074712 Jones Contract Packaging Services LACTULOSE 10 g/10g Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20191231 67414-729_639e537b-3803-6948-e053-2a91aa0af22c 67414-729 HUMAN PRESCRIPTION DRUG Kristalose Lactulose POWDER, FOR SOLUTION ORAL 20180124 ANDA ANDA074712 Jones Contract Packaging Services LACTULOSE 20 g/20g Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20191231 67425-002_ec2bd376-a904-8ef4-0daf-0b071de70e9c 67425-002 HUMAN PRESCRIPTION DRUG VITRASE hyaluronidase, ovine INJECTION, SOLUTION SUBCUTANEOUS 20050201 NDA NDA021640 ISTA Pharmaceuticals, Inc. HYALURONIDASE, OVINE 200 [USP'U]/mL Endoglycosidase [EPC],Glycoside Hydrolases [Chemical/Ingredient] E 20171231 67441-0001_5de233fa-49c1-48e6-b2f6-2f702c80913b 67441-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030301 UNAPPROVED MEDICAL GAS Plaza Home Care, Inc. OXYGEN 99 L/100L E 20171231 67457-001_9fce64c8-79e6-4325-b5b4-ebc419bd2d0e 67457-001 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride Ketamine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130604 ANDA ANDA076092 Mylan Institutional LLC KETAMINE HYDROCHLORIDE 50 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 67457-108_9fce64c8-79e6-4325-b5b4-ebc419bd2d0e 67457-108 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride Ketamine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130604 ANDA ANDA076092 Mylan Institutional LLC KETAMINE HYDROCHLORIDE 100 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 67457-118_daf0d15f-756d-4142-abd7-a7dbd5763769 67457-118 HUMAN PRESCRIPTION DRUG Ascorbic Acid Ascorbic Acid INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19990601 UNAPPROVED DRUG OTHER Mylan Institutional LLC ASCORBIC ACID 500 mg/mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20181231 67457-124_27c11543-21b0-44f2-a9e3-8eb433dea382 67457-124 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130509 ANDA ANDA040498 Mylan Institutional LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 67457-134_5d074715-0142-4e7f-af09-2956d21c675e 67457-134 HUMAN PRESCRIPTION DRUG Magnesium Chloride magnesium chloride INJECTION INTRAVENOUS 20130314 UNAPPROVED DRUG OTHER Mylan Institutional LLC MAGNESIUM CHLORIDE 200 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20181231 67457-146_9160e788-7e5f-41ef-89f6-0350c132fa39 67457-146 HUMAN PRESCRIPTION DRUG Vitamin B Complex thiamine hydrochloride, riboflavin 5 phosphate sodium, dexpanthenol and niacinamide INJECTION INTRAVENOUS 20130510 UNAPPROVED DRUG OTHER Mylan Institutional LLC THIAMINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; DEXPANTHENOL; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE 100; 2; 2; 100; 2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 67457-153_59b25942-ac24-4084-8a60-2036851f9126 67457-153 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride amiodarone hydrochloride INJECTION, SOLUTION INTRAVENOUS 20021014 ANDA ANDA076217 Mylan Institutional LLC AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 67457-162_6cb14cf0-615c-4a84-9a02-90b338749ecd 67457-162 HUMAN PRESCRIPTION DRUG Sotradecol tetradecyl hydrogen sulfate (ester) INJECTION, SOLUTION INTRAVENOUS 20130429 ANDA ANDA040541 Mylan Institutional LLC TETRADECYL HYDROGEN SULFATE (ESTER) 10 mg/mL N 20191231 67457-163_6cb14cf0-615c-4a84-9a02-90b338749ecd 67457-163 HUMAN PRESCRIPTION DRUG Sotradecol tetradecyl hydrogen sulfate (ester) INJECTION, SOLUTION INTRAVENOUS 20130429 ANDA ANDA040541 Mylan Institutional LLC TETRADECYL HYDROGEN SULFATE (ESTER) 30 mg/mL N 20191231 67457-176_79325341-258f-4ad1-b554-8b51512f0e9f 67457-176 HUMAN PRESCRIPTION DRUG Sotalol hydrochloride Sotalol hydrochloride INJECTION INTRAVENOUS 20090930 NDA NDA022306 Mylan Institutional LLC SOTALOL HYDROCHLORIDE 15 mg/mL Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 67457-177_02329de4-a665-4b61-8a6a-54daadd52045 67457-177 HUMAN PRESCRIPTION DRUG RIMSO-50 Dimethyl Sulfoxide IRRIGANT INTRAVESICAL 19780404 NDA NDA017788 Mylan Institutional LLC DIMETHYL SULFOXIDE .54 g/mL N 20181231 67457-181_9fce64c8-79e6-4325-b5b4-ebc419bd2d0e 67457-181 HUMAN PRESCRIPTION DRUG Ketamine Hydrochloride Ketamine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130604 ANDA ANDA076092 Mylan Institutional LLC KETAMINE HYDROCHLORIDE 10 mg/mL General Anesthesia [PE],General Anesthetic [EPC] CIII N 20181231 67457-182_1418b9ce-6533-4f31-96e3-3f24f5073371 67457-182 HUMAN PRESCRIPTION DRUG Esmolol Hydrochloride esmolol hydrochloride INJECTION, SOLUTION INTRAVENOUS 20070529 ANDA ANDA076474 Mylan Institutional LLC ESMOLOL HYDROCHLORIDE 10 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67457-183_1bf58b60-2972-4900-b2cd-300fb79edf7c 67457-183 HUMAN PRESCRIPTION DRUG Etomidate etomidate INJECTION, SOLUTION INTRAVENOUS 20130426 ANDA ANDA091297 Mylan Institutional LLC ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 67457-187_7813add0-cb10-442f-8714-7f42a31b6d3c 67457-187 HUMAN PRESCRIPTION DRUG Aloprim Allopurinol INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20070515 NDA NDA020298 Mylan Institutional LLC ALLOPURINOL 500 mg/25mL Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 67457-190_91687c49-8f28-499e-9999-9b51154ad379 67457-190 HUMAN PRESCRIPTION DRUG Enlon edrophonium chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130422 ANDA ANDA088873 Mylan Institutional LLC EDROPHONIUM CHLORIDE 10 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 67457-195_9ed91e34-da39-4814-8fb5-03a4f0530ea3 67457-195 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride KIT 20130110 ANDA ANDA090270 Mylan Institutional LLC N 20181231 67457-196_7f6e2dc2-4650-4fdd-85d7-f6c31861281e 67457-196 HUMAN PRESCRIPTION DRUG Thiamine Hydrochloride thiamine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130604 ANDA ANDA091623 Mylan Institutional LLC THIAMINE HYDROCHLORIDE 100 mg/mL N 20181231 67457-197_7cc0eb3f-f115-46b7-b4e6-4e1a4836ae55 67457-197 HUMAN PRESCRIPTION DRUG Tranexamic Acid tranexamic acid INJECTION, SOLUTION INTRAVENOUS 20111129 ANDA ANDA091657 Mylan Institutional LLC TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20191231 67457-198_6d30fdea-3c76-4be6-9814-372c8f55499b 67457-198 HUMAN PRESCRIPTION DRUG Ultiva Remifentanil Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19961106 NDA NDA020630 Mylan Institutional LLC REMIFENTANIL HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67457-207_6525cd27-ac93-4f2d-bf6b-fc473cdf1de9 67457-207 HUMAN PRESCRIPTION DRUG Dexrazoxane Hydrochloride dexrazoxane KIT 20111118 ANDA ANDA200752 Mylan Institutional LLC N 20181231 67457-208_6525cd27-ac93-4f2d-bf6b-fc473cdf1de9 67457-208 HUMAN PRESCRIPTION DRUG Dexrazoxane Hydrochloride dexrazoxane KIT 20111118 ANDA ANDA200752 Mylan Institutional LLC N 20181231 67457-210_cdf09920-bfe5-407c-921f-f4aefca3e29e 67457-210 HUMAN PRESCRIPTION DRUG Cidofovir Cidofovir Anhydrous INJECTION, SOLUTION INTRAVENOUS 20130603 ANDA ANDA201276 Mylan Institutional LLC CIDOFOVIR 75 mg/mL Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient] N 20181231 67457-211_be2c337b-ea12-46e4-82e0-fb3e3620b7ca 67457-211 HUMAN PRESCRIPTION DRUG Fomepizole Fomepizole INJECTION, SOLUTION INTRAVENOUS 20121009 ANDA ANDA078639 Mylan Institutional LLC FOMEPIZOLE 1 g/mL Antidote [EPC] N 20181231 67457-212_b0dedf95-8395-46bf-b94a-dcf2dd085942 67457-212 HUMAN PRESCRIPTION DRUG Argatroban argatroban INJECTION, SOLUTION INTRAVENOUS 20171114 ANDA ANDA202626 Mylan Institutional LLC ARGATROBAN 250 mg/2.5mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 67457-215_cbfd87e5-f501-4f4f-9dc3-7480cc7ae521 67457-215 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride KIT 20130110 ANDA ANDA090270 Mylan Institutional LLC N 20181231 67457-217_2b58332f-d259-4a42-b400-24f44d7a1a09 67457-217 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20121220 NDA NDA021624 Mylan Institutional LLC METHADONE HYDROCHLORIDE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67457-218_e0d1bb23-364b-4afe-b915-46bbd12fa733 67457-218 HUMAN PRESCRIPTION DRUG Duraclon clonidine hydrochloride INJECTION, SOLUTION EPIDURAL 19970126 NDA NDA020615 Mylan Institutional LLC CLONIDINE HYDROCHLORIDE .1 mg/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 67457-219_e0d1bb23-364b-4afe-b915-46bbd12fa733 67457-219 HUMAN PRESCRIPTION DRUG Duraclon clonidine hydrochloride INJECTION, SOLUTION EPIDURAL 20000204 NDA NDA020615 Mylan Institutional LLC CLONIDINE HYDROCHLORIDE .5 mg/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 67457-220_1c3efaf1-6ca5-41b8-a9c1-dfaffd65d287 67457-220 HUMAN PRESCRIPTION DRUG Isosulfan Blue Isosulfan Blue INJECTION, SOLUTION SUBCUTANEOUS 20130314 ANDA ANDA090874 Mylan Institutional LLC ISOSULFAN BLUE 10 mg/mL N 20181231 67457-221_314a6af2-e75d-4dfe-a944-8298d03db6c2 67457-221 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120627 ANDA ANDA040716 Mylan Institutional LLC METHOTREXATE 1 g/40mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 67457-222_7214b684-0407-4d5b-ad56-1a97fdd4cc93 67457-222 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080630 ANDA ANDA065401 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 67457-225_7214b684-0407-4d5b-ad56-1a97fdd4cc93 67457-225 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120110 ANDA ANDA065401 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 67457-227_f2f081d1-7608-417b-ba54-957a03e8cb85 67457-227 HUMAN PRESCRIPTION DRUG Cosyntropin cosyntropin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130508 ANDA ANDA090574 Mylan Institutional LLC COSYNTROPIN .25 mg/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] N 20181231 67457-228_abeb5328-fcbb-47a2-80d9-df93696bd853 67457-228 HUMAN PRESCRIPTION DRUG Rocuronium Bromide rocuronium bromide INJECTION INTRAVENOUS 20120206 ANDA ANDA079199 Mylan Institutional LLC ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 67457-239_8ef08ff0-1497-4734-ae76-f3a2ca7fdcd9 67457-239 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20110401 ANDA ANDA079198 Mylan Institutional LLC OCTREOTIDE ACETATE 50 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 67457-245_8ef08ff0-1497-4734-ae76-f3a2ca7fdcd9 67457-245 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20110401 ANDA ANDA079198 Mylan Institutional LLC OCTREOTIDE ACETATE 100 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 67457-246_8ef08ff0-1497-4734-ae76-f3a2ca7fdcd9 67457-246 HUMAN PRESCRIPTION DRUG Octreotide Acetate octreotide acetate INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20110401 ANDA ANDA079198 Mylan Institutional LLC OCTREOTIDE ACETATE 500 ug/mL Somatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA] N 20181231 67457-251_9a839e31-689d-4980-8b40-539f87387dc4 67457-251 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride dexmedetomidine hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140818 ANDA ANDA202881 Mylan Institutional LLC DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 67457-254_412182c6-91b9-4082-921e-c1f92fd0c941 67457-254 HUMAN PRESCRIPTION DRUG Azacitidine azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20160523 ANDA ANDA204949 Mylan Institutional LLC AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 67457-255_367656ab-7d67-4c98-9101-458d28c1b8c2 67457-255 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION INTRAVENOUS 20120116 NDA NDA202543 Mylan Institutional LLC LEVETIRACETAM 5 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 67457-257_f2f081d1-7608-417b-ba54-957a03e8cb85 67457-257 HUMAN PRESCRIPTION DRUG Cosyntropin cosyntropin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130508 ANDA ANDA090574 Mylan Institutional LLC COSYNTROPIN .25 mg/mL Adrenocorticotropic Hormone [Chemical/Ingredient],Adrenocorticotropic Hormone [EPC] N 20181231 67457-263_93f88b2a-7932-43f0-b000-882353993d9d 67457-263 HUMAN PRESCRIPTION DRUG chlorothiazide sodium chlorothiazide sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140808 ANDA ANDA202493 Mylan Institutional LLC CHLOROTHIAZIDE SODIUM 500 mg/18mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67457-265_367656ab-7d67-4c98-9101-458d28c1b8c2 67457-265 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION INTRAVENOUS 20120116 NDA NDA202543 Mylan Institutional LLC LEVETIRACETAM 10 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 67457-266_367656ab-7d67-4c98-9101-458d28c1b8c2 67457-266 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION INTRAVENOUS 20120116 NDA NDA202543 Mylan Institutional LLC LEVETIRACETAM 15 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 67457-273_0479d918-67ff-4519-a330-db757167dd8f 67457-273 HUMAN PRESCRIPTION DRUG METHOCARBAMOL methocarbamol INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141205 ANDA ANDA204404 Mylan Institutional LLC METHOCARBAMOL 100 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67457-281_ce454abe-af03-4cf2-9c02-7ad1521a475c 67457-281 HUMAN PRESCRIPTION DRUG Pyridoxine Hydrochloride pyridoxine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160901 ANDA ANDA204879 Mylan Institutional LLC PYRIDOXINE HYDROCHLORIDE 100 mg/mL Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20191231 67457-291_ab4c9bdd-62bd-4a7a-a3d2-ee8c9998e79e 67457-291 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride hydralazine hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160429 ANDA ANDA204680 Mylan Institutional LLC HYDRALAZINE HYDROCHLORIDE 20 mg/mL Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 67457-292_b9116f27-e25d-48cf-b0ea-1a22afbfbee9 67457-292 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride naloxone hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20140306 ANDA ANDA204997 Mylan Institutional LLC NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 67457-297_f108e431-f8d3-4442-8a60-bfc1d8a7bafc 67457-297 HUMAN PRESCRIPTION DRUG Ethacrynic Sodium ethacrynic sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160831 ANDA ANDA204634 Mylan Institutional LLC ETHACRYNATE SODIUM 50 mg/50mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 67457-299_157a7494-7cd0-4579-8208-dd1397ad5adf 67457-299 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride naloxone hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20160914 ANDA ANDA205014 Mylan Institutional LLC NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 67457-323_c6fa4129-2f92-4179-ac5d-bb7b4a538789 67457-323 HUMAN PRESCRIPTION DRUG MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20171003 ANDA ANDA205833 Mylan Institutional LLC MOXIFLOXACIN HYDROCHLORIDE 400 mg/250mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 67457-339_c711f615-cb79-4ad5-96e9-85251ab67ca2 67457-339 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065397 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 67457-340_c711f615-cb79-4ad5-96e9-85251ab67ca2 67457-340 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065397 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 67457-341_b3e7f333-daa1-43b8-99c0-fdb0fc18b723 67457-341 HUMAN PRESCRIPTION DRUG vancomycin hydrochloride vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065432 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 67457-342_c37d4a1b-8931-4879-b61f-a9179f6ed2a2 67457-342 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110919 ANDA ANDA091554 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 67457-348_ef51ceff-feff-4b94-b030-7328d08f8001 67457-348 HUMAN PRESCRIPTION DRUG ampicillin sodium and sulbactam sodium ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140408 ANDA ANDA201024 Mylan Institutional LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 1; .5 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20191231 67457-349_ef51ceff-feff-4b94-b030-7328d08f8001 67457-349 HUMAN PRESCRIPTION DRUG ampicillin sodium and sulbactam sodium ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140408 ANDA ANDA201024 Mylan Institutional LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 2; 1 g/1; g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20191231 67457-350_3efaea4e-a856-41d1-8095-b5f2c2af519f 67457-350 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160912 ANDA ANDA201025 Mylan Institutional LLC AMPICILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67457-351_3efaea4e-a856-41d1-8095-b5f2c2af519f 67457-351 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160912 ANDA ANDA201025 Mylan Institutional LLC AMPICILLIN SODIUM 1 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67457-352_3efaea4e-a856-41d1-8095-b5f2c2af519f 67457-352 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160912 ANDA ANDA201025 Mylan Institutional LLC AMPICILLIN SODIUM 2 g/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67457-353_3efaea4e-a856-41d1-8095-b5f2c2af519f 67457-353 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160912 ANDA ANDA201025 Mylan Institutional LLC AMPICILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67457-366_7e63ba88-36c9-4228-917c-f9a92c86965e 67457-366 HUMAN PRESCRIPTION DRUG Ibutilide Fumarate Ibutilide Fumarate INJECTION, SOLUTION INTRAVENOUS 20100111 ANDA ANDA090643 Mylan Institutional LLC IBUTILIDE FUMARATE .1 mg/mL Antiarrhythmic [EPC] N 20181231 67457-381_5cb2c072-8782-4f5b-834f-6fe97991598c 67457-381 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Mylan Institutional LLC HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] N 20181231 67457-382_5cb2c072-8782-4f5b-834f-6fe97991598c 67457-382 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Mylan Institutional LLC HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] N 20181231 67457-390_fac82bea-771e-454a-9bfb-cd5a1a3ecad0 67457-390 HUMAN PRESCRIPTION DRUG Zoledronic acid Zoledronic acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130305 ANDA ANDA202650 Mylan Institutional LLC ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 67457-393_d3c5bcdc-9231-4b5a-a9cd-4c85cab45df1 67457-393 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION INTRAVENOUS 20120214 ANDA ANDA200901 Mylan Institutional LLC DOXORUBICIN HYDROCHLORIDE 10 mg/5mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20191231 67457-394_d3c5bcdc-9231-4b5a-a9cd-4c85cab45df1 67457-394 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION INTRAVENOUS 20120214 ANDA ANDA200901 Mylan Institutional LLC DOXORUBICIN HYDROCHLORIDE 20 mg/10mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20191231 67457-395_d3c5bcdc-9231-4b5a-a9cd-4c85cab45df1 67457-395 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION INTRAVENOUS 20120214 ANDA ANDA200901 Mylan Institutional LLC DOXORUBICIN HYDROCHLORIDE 50 mg/25mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20191231 67457-396_d3c5bcdc-9231-4b5a-a9cd-4c85cab45df1 67457-396 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION INTRAVENOUS 20120214 ANDA ANDA200901 Mylan Institutional LLC DOXORUBICIN HYDROCHLORIDE 200 mg/100mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20191231 67457-399_33a7f642-bf79-42be-9127-5121be83f092 67457-399 HUMAN PRESCRIPTION DRUG cyanocobalamine cyanocobalamine INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20170706 ANDA ANDA204829 Mylan Institutional LLC CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 67457-400_33a7f642-bf79-42be-9127-5121be83f092 67457-400 HUMAN PRESCRIPTION DRUG cyanocobalamine cyanocobalamine INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20170706 ANDA ANDA204829 Mylan Institutional LLC CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 67457-404_e868fd92-6c5f-49c7-891b-eba587c94af2 67457-404 HUMAN PRESCRIPTION DRUG Ampicillin Sodium Ampicillin Sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140408 ANDA ANDA202198 Mylan Institutional LLC AMPICILLIN SODIUM 10 g/100mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 67457-409_5cb2c072-8782-4f5b-834f-6fe97991598c 67457-409 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Mylan Institutional LLC HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] N 20181231 67457-410_5cb2c072-8782-4f5b-834f-6fe97991598c 67457-410 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20130423 ANDA ANDA075440 Mylan Institutional LLC HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] N 20181231 67457-420_ad779cfd-d8e6-420a-853f-3d087d7d7b8f 67457-420 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110511 ANDA ANDA040802 Mylan Institutional LLC DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67457-421_ad779cfd-d8e6-420a-853f-3d087d7d7b8f 67457-421 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Mylan Institutional LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67457-422_ad779cfd-d8e6-420a-853f-3d087d7d7b8f 67457-422 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Mylan Institutional LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67457-423_ad779cfd-d8e6-420a-853f-3d087d7d7b8f 67457-423 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20110511 ANDA ANDA040803 Mylan Institutional LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67457-426_8f6d2394-ed41-4307-80de-28fbeea85bcb 67457-426 HUMAN PRESCRIPTION DRUG HALOPERIDOL LACTATE HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20110510 ANDA ANDA078347 Mylan Institutional LLC HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20181231 67457-427_99315f03-ebbe-4879-97e5-7b9352c9c297 67457-427 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION INTRAMUSCULAR; INTRAVENOUS 20080312 ANDA ANDA065407 Mylan Institutional LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 67457-428_1454cd5d-3df9-4f07-8e00-830844a0f8b3 67457-428 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA065407 Mylan Institutional LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 67457-429_4a2f8f58-5b87-44f9-aa33-28efd5064293 67457-429 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION, SOLUTION INTRAVENOUS 20121127 ANDA ANDA201689 Mylan Institutional LLC IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 67457-430_8d56d4aa-61a1-4fcf-a067-8c584823ad18 67457-430 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION INTRAVENOUS 20081101 ANDA ANDA078520 Mylan Institutional LLC PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 67457-432_99315f03-ebbe-4879-97e5-7b9352c9c297 67457-432 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION INTRAMUSCULAR; INTRAVENOUS 20080312 ANDA ANDA065407 Mylan Institutional LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] E 20171231 67457-433_6d429238-3064-45d5-af55-3cbf22e53d58 67457-433 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION INTRAVENOUS 20080626 ANDA ANDA078642 Mylan Institutional LLC FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 67457-434_fbfd2fc4-7d02-439c-8032-099b08b02781 67457-434 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION INTRAVENOUS 20110930 ANDA ANDA091540 Mylan Institutional LLC PACLITAXEL 300 mg/50mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 67457-436_4f2bc26f-8cb4-4e85-a1ab-782b4ceba849 67457-436 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111029 ANDA ANDA200170 Mylan Institutional LLC DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 67457-438_48a363e7-d35d-49de-83a4-de632602605a 67457-438 HUMAN PRESCRIPTION DRUG VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110511 ANDA ANDA090243 Mylan Institutional LLC VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 67457-440_ce2e97af-7819-4481-94e9-226061c41b1e 67457-440 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141229 ANDA ANDA079224 Mylan Institutional LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 67457-441_ce2e97af-7819-4481-94e9-226061c41b1e 67457-441 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141229 ANDA ANDA090648 Mylan Institutional LLC ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 67457-442_b3e97a3f-d9f3-48c0-bdbd-d26a5e2b7ba0 67457-442 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20120809 ANDA ANDA091358 Mylan Institutional LLC OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 67457-443_4a2f8f58-5b87-44f9-aa33-28efd5064293 67457-443 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION, SOLUTION INTRAVENOUS 20121127 ANDA ANDA201689 Mylan Institutional LLC IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 67457-444_51f59d64-76b8-4edb-b127-277621cfe029 67457-444 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078595 Mylan Institutional LLC FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 67457-445_f5c78c71-fe29-43b7-a4be-fdb874ca3973 67457-445 HUMAN PRESCRIPTION DRUG Rifampin Rifampin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080523 ANDA ANDA065421 Mylan Institutional LLC RIFAMPIN 600 mg/10mL Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 67457-446_8d56d4aa-61a1-4fcf-a067-8c584823ad18 67457-446 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION INTRAVENOUS 20081101 ANDA ANDA078520 Mylan Institutional LLC PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 67457-447_51f59d64-76b8-4edb-b127-277621cfe029 67457-447 HUMAN PRESCRIPTION DRUG Flumazenil Flumazenil INJECTION, SOLUTION INTRAVENOUS 20110510 ANDA ANDA078595 Mylan Institutional LLC FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 67457-448_6d429238-3064-45d5-af55-3cbf22e53d58 67457-448 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION INTRAVENOUS 20080626 ANDA ANDA078641 Mylan Institutional LLC FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 67457-449_fbfd2fc4-7d02-439c-8032-099b08b02781 67457-449 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION INTRAVENOUS 20110930 ANDA ANDA091540 Mylan Institutional LLC PACLITAXEL 100 mg/16.7mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 67457-450_69aee660-f40b-46e8-97de-0cfc2caf4377 67457-450 HUMAN PRESCRIPTION DRUG Cladribine Cladribine INJECTION INTRAVENOUS 20110710 ANDA ANDA200510 Mylan Institutional LLC CLADRIBINE 1 mg/mL Purine Antimetabolite [EPC] N 20181231 67457-452_8eb6d1e3-267f-4b87-8e97-8e51da741d80 67457-452 HUMAN PRESCRIPTION DRUG Cytarabine Cytarabine INJECTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 20120131 ANDA ANDA201784 Mylan Institutional LLC CYTARABINE 2 g/20mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 67457-454_a6463842-d20c-4552-adee-c4a1d5de8cbc 67457-454 HUMAN PRESCRIPTION DRUG Cytarabine Cytarabine INJECTION INTRAVENOUS; SUBCUTANEOUS 20111214 ANDA ANDA200914 Mylan Institutional LLC CYTARABINE 20 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 67457-455_ee6decae-7e1b-45cf-b2d0-c15946d8fa1f 67457-455 HUMAN PRESCRIPTION DRUG cytarabine cytarabine INJECTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 20111214 ANDA ANDA200915 Mylan Institutional LLC CYTARABINE 100 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 67457-456_63b9c250-88d2-4b24-83f4-5b8ce14ee95c 67457-456 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20120203 ANDA ANDA078289 Mylan Institutional LLC ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 67457-457_6d429238-3064-45d5-af55-3cbf22e53d58 67457-457 HUMAN PRESCRIPTION DRUG Famotidine Famotidine INJECTION INTRAVENOUS 20080626 ANDA ANDA078641 Mylan Institutional LLC FAMOTIDINE 10 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 67457-462_c06d0afe-0236-4137-8dd9-bdfa12b4644d 67457-462 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA200145 Mylan Institutional LLC GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 67457-463_c06d0afe-0236-4137-8dd9-bdfa12b4644d 67457-463 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA200145 Mylan Institutional LLC GEMCITABINE HYDROCHLORIDE 2 g/50mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 67457-464_c06d0afe-0236-4137-8dd9-bdfa12b4644d 67457-464 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA200145 Mylan Institutional LLC GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 67457-465_26308cf7-b6db-4f5f-8894-373597a3d910 67457-465 HUMAN PRESCRIPTION DRUG methotrexate sodium methotrexate sodium INJECTION, SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Mylan Institutional LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] E 20171231 67457-466_0ab21edf-c92c-4acd-a7ea-0734c880f7e1 67457-466 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Mylan Institutional LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 67457-467_0ab21edf-c92c-4acd-a7ea-0734c880f7e1 67457-467 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Mylan Institutional LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 67457-468_a7bb542e-29f6-4b99-8fa3-f9e5de822a6e 67457-468 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin POWDER, FOR SOLUTION INTRAVENOUS 20120809 ANDA ANDA200979 Mylan Institutional LLC OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] E 20171231 67457-469_b3e97a3f-d9f3-48c0-bdbd-d26a5e2b7ba0 67457-469 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20120809 ANDA ANDA091358 Mylan Institutional LLC OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 67457-471_fbfd2fc4-7d02-439c-8032-099b08b02781 67457-471 HUMAN PRESCRIPTION DRUG Paclitaxel Paclitaxel INJECTION INTRAVENOUS 20110930 ANDA ANDA091540 Mylan Institutional LLC PACLITAXEL 30 mg/5mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 67457-472_d543979d-31d4-4147-9919-b04ebbd6a22f 67457-472 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION INTRAVENOUS 20081101 ANDA ANDA078520 Mylan Institutional LLC PAMIDRONATE DISODIUM 3 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 67457-473_1454cd5d-3df9-4f07-8e00-830844a0f8b3 67457-473 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin INJECTION INTRAMUSCULAR; INTRAVENOUS 20110510 ANDA ANDA065407 Mylan Institutional LLC TOBRAMYCIN SULFATE 40 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 67457-474_72d829bb-4c11-4ccb-8a3d-005d7c1d6ffe 67457-474 HUMAN PRESCRIPTION DRUG TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120829 ANDA ANDA091542 Mylan Institutional LLC TOPOTECAN HYDROCHLORIDE 4 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] E 20171231 67457-475_48a363e7-d35d-49de-83a4-de632602605a 67457-475 HUMAN PRESCRIPTION DRUG VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110511 ANDA ANDA090243 Mylan Institutional LLC VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 67457-476_a7bb542e-29f6-4b99-8fa3-f9e5de822a6e 67457-476 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin POWDER, FOR SOLUTION INTRAVENOUS 20120809 ANDA ANDA200979 Mylan Institutional LLC OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] E 20171231 67457-477_63b9c250-88d2-4b24-83f4-5b8ce14ee95c 67457-477 HUMAN PRESCRIPTION DRUG Etomidate Etomidate INJECTION, SOLUTION INTRAVENOUS 20120203 ANDA ANDA078289 Mylan Institutional LLC ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 67457-478_4f2bc26f-8cb4-4e85-a1ab-782b4ceba849 67457-478 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111029 ANDA ANDA200170 Mylan Institutional LLC DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 67457-480_227498c9-7baa-4b27-a56f-97752c1942fb 67457-480 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20171003 ANDA ANDA201530 Mylan Institutional LLC METHOTREXATE 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 67457-485_0ab21edf-c92c-4acd-a7ea-0734c880f7e1 67457-485 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Mylan Institutional LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 67457-486_0ab21edf-c92c-4acd-a7ea-0734c880f7e1 67457-486 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate INJECTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS 20120330 ANDA ANDA201529 Mylan Institutional LLC METHOTREXATE SODIUM 25 mg/mL Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 67457-495_7c3713bd-288b-42df-94e2-8873675e9f2b 67457-495 HUMAN PRESCRIPTION DRUG Fludarabine Phosphate Fludarabine Phosphate INJECTION INTRAVENOUS 20111222 ANDA ANDA200647 Mylan Institutional LLC FLUDARABINE PHOSPHATE 25 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 67457-513_5dc19443-1bac-4bb4-893e-e791b72b3d26 67457-513 HUMAN PRESCRIPTION DRUG Dactinomycin Dactinomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20180101 ANDA ANDA203385 Mylan Institutional LLC DACTINOMYCIN .5 mg/mL Actinomycin [EPC],Nucleic Acid Synthesis Inhibitors [MoA],Protein Synthesis Inhibitors [MoA] N 20191231 67457-516_564feac7-eb0d-42a0-a0f1-9613deeb0cec 67457-516 HUMAN PRESCRIPTION DRUG fosphenytoin sodium fosphenytoin sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161206 ANDA ANDA078736 Mylan Institutional LLC FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 67457-517_564feac7-eb0d-42a0-a0f1-9613deeb0cec 67457-517 HUMAN PRESCRIPTION DRUG fosphenytoin sodium fosphenytoin sodium INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161206 ANDA ANDA078736 Mylan Institutional LLC FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 67457-521_da3c6a7b-e383-49b5-9004-2812acae34fd 67457-521 HUMAN PRESCRIPTION DRUG piperacillin and tazobactam piperacillin and tazobactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140816 ANDA ANDA065458 Mylan Institutional LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 2; .25 g/10mL; g/10mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 67457-522_da3c6a7b-e383-49b5-9004-2812acae34fd 67457-522 HUMAN PRESCRIPTION DRUG piperacillin and tazobactam piperacillin and tazobactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140816 ANDA ANDA065458 Mylan Institutional LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 3; .375 g/15mL; g/15mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 67457-523_da3c6a7b-e383-49b5-9004-2812acae34fd 67457-523 HUMAN PRESCRIPTION DRUG piperacillin and tazobactam piperacillin and tazobactam INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140816 ANDA ANDA065458 Mylan Institutional LLC PIPERACILLIN SODIUM; TAZOBACTAM SODIUM 4; .5 g/20mL; g/20mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 67457-524_4b6cecb5-336c-4909-8cba-823a4a62e775 67457-524 HUMAN PRESCRIPTION DRUG ibandronate sodium ibandronate sodium INJECTION, SOLUTION INTRAVENOUS 20140902 ANDA ANDA202671 Mylan Institutional LLC IBANDRONATE SODIUM 3 mg/3mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20191231 67457-546_1f8ac128-c25d-41f4-9f90-410a792acd66 67457-546 HUMAN PRESCRIPTION DRUG clofarabine clofarabine INJECTION INTRAVENOUS 20171106 ANDA ANDA208860 Mylan Institutional LLC CLOFARABINE 1 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 67457-571_47103892-f193-4ff8-b591-5fb1e5ad3cab 67457-571 HUMAN PRESCRIPTION DRUG VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110511 ANDA ANDA090243 Mylan Institutional LLC VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 67457-572_47103892-f193-4ff8-b591-5fb1e5ad3cab 67457-572 HUMAN PRESCRIPTION DRUG VECURONIUM BROMIDE VECURONIUM BROMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110511 ANDA ANDA090243 Mylan Institutional LLC VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 67457-573_8c053988-305d-4cb9-ad10-604af0daa318 67457-573 HUMAN PRESCRIPTION DRUG Rocuronium Bromide rocuronium bromide INJECTION INTRAVENOUS 20140929 ANDA ANDA079199 Mylan Institutional LLC ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 67457-574_8c053988-305d-4cb9-ad10-604af0daa318 67457-574 HUMAN PRESCRIPTION DRUG Rocuronium Bromide rocuronium bromide INJECTION INTRAVENOUS 20140929 ANDA ANDA079199 Mylan Institutional LLC ROCURONIUM BROMIDE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 67457-579_4ec55acb-5f54-443a-b5ed-573d34ce5b42 67457-579 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride KIT 20140929 ANDA ANDA090270 Mylan Institutional LLC N 20181231 67457-581_abaea34e-9ea3-4aec-8410-d59c561e919e 67457-581 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride dexmedetomidine hydrochloride INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140818 ANDA ANDA202881 Mylan Institutional LLC DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] N 20181231 67457-582_ca7283bf-8d10-4368-866b-b06a316ebed5 67457-582 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20150105 NDA AUTHORIZED GENERIC NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 2.5 mg/.5mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 67457-583_ca7283bf-8d10-4368-866b-b06a316ebed5 67457-583 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20150105 NDA AUTHORIZED GENERIC NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 5 mg/.4mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 67457-584_ca7283bf-8d10-4368-866b-b06a316ebed5 67457-584 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20150105 NDA AUTHORIZED GENERIC NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 67457-585_ca7283bf-8d10-4368-866b-b06a316ebed5 67457-585 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20150105 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 10 mg/.8mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 67457-586_254c3a8d-e081-4f80-84bc-6eaeabeefcd9 67457-586 HUMAN PRESCRIPTION DRUG Isosulfan Blue Isosulfan Blue INJECTION, SOLUTION SUBCUTANEOUS 20150326 ANDA ANDA090874 Mylan Institutional LLC ISOSULFAN BLUE 10 mg/mL N 20181231 67457-592_8914754d-8bc2-488f-ac60-c97f8f139673 67457-592 HUMAN PRESCRIPTION DRUG Arixtra fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20150506 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 2.5 mg/.5mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 67457-593_8914754d-8bc2-488f-ac60-c97f8f139673 67457-593 HUMAN PRESCRIPTION DRUG Arixtra fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20150807 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 5 mg/.4mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 67457-594_8914754d-8bc2-488f-ac60-c97f8f139673 67457-594 HUMAN PRESCRIPTION DRUG Arixtra fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20160211 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 67457-595_8914754d-8bc2-488f-ac60-c97f8f139673 67457-595 HUMAN PRESCRIPTION DRUG Arixtra fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20151113 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 10 mg/.8mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 67457-599_0f9831b9-7d87-465c-95a9-a8d2cff08791 67457-599 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride naloxone hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20141217 ANDA ANDA204997 Mylan Institutional LLC NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 67457-600_eeae9510-f671-4ae1-a0a2-22c2ad782dbc 67457-600 HUMAN PRESCRIPTION DRUG LEVOLEUCOVORIN CALCIUM Levoleucovorin INJECTION, SOLUTION INTRAVENOUS 20151021 ANDA ANDA203576 Mylan Institutional LLC LEVOLEUCOVORIN CALCIUM 10 mg/mL N 20181231 67457-601_eeae9510-f671-4ae1-a0a2-22c2ad782dbc 67457-601 HUMAN PRESCRIPTION DRUG LEVOLEUCOVORIN CALCIUM Levoleucovorin INJECTION, SOLUTION INTRAVENOUS 20151021 ANDA ANDA203576 Mylan Institutional LLC LEVOLEUCOVORIN CALCIUM 10 mg/mL N 20181231 67457-609_9273052f-cd52-4452-b3eb-a78984b852ad 67457-609 HUMAN PRESCRIPTION DRUG Ifosfamide Ifosfamide INJECTION, SOLUTION INTRAVENOUS 20121127 ANDA ANDA201689 Mylan Institutional LLC IFOSFAMIDE 50 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 67457-610_d543979d-31d4-4147-9919-b04ebbd6a22f 67457-610 HUMAN PRESCRIPTION DRUG Pamidronate Disodium Pamidronate Disodium INJECTION INTRAVENOUS 20081101 ANDA ANDA078520 Mylan Institutional LLC PAMIDRONATE DISODIUM 9 mg/mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 67457-611_5e5c8fd7-d2c7-4be8-8a3b-40c3d92f5274 67457-611 HUMAN PRESCRIPTION DRUG vancomycin hydrochloride vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065397 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 67457-612_5e5c8fd7-d2c7-4be8-8a3b-40c3d92f5274 67457-612 HUMAN PRESCRIPTION DRUG vancomycin hydrochloride vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065397 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 67457-613_d1e08b5b-7223-467d-9bc8-dd4a04ed64da 67457-613 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20081231 ANDA ANDA065432 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 5 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 67457-614_a759b52d-48f8-4e8a-aaaf-e2f88298f617 67457-614 HUMAN PRESCRIPTION DRUG Vancomycin hydrochloride Vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110919 ANDA ANDA091554 Mylan Institutional LLC VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 67457-615_9c5179ca-1a55-4e41-8994-ed0ce2489f34 67457-615 HUMAN PRESCRIPTION DRUG cytarabine Cytarabine INJECTION INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS 20120131 ANDA ANDA201784 Mylan Institutional LLC CYTARABINE 2 g/20mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 67457-616_571203a9-0804-4027-b1f3-7912b0b5a062 67457-616 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20180103 ANDA ANDA205242 Mylan Institutional LLC GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 67457-617_571203a9-0804-4027-b1f3-7912b0b5a062 67457-617 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20171218 ANDA ANDA205242 Mylan Institutional LLC GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 67457-618_571203a9-0804-4027-b1f3-7912b0b5a062 67457-618 HUMAN PRESCRIPTION DRUG Gemcitabine GEMCITABINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20171218 ANDA ANDA205242 Mylan Institutional LLC GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 67457-619_f2d457a0-bf18-43cf-ac79-8b72d74d8042 67457-619 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20170519 ANDA ANDA203841 Mylan Institutional LLC ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 67457-649_ce394e7a-4a5f-4d52-ba16-d53070a40790 67457-649 HUMAN PRESCRIPTION DRUG ampicillin sodium and sulbactam sodium ampicillin sodium and sulbactam sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20140408 ANDA ANDA202197 Mylan Institutional LLC AMPICILLIN SODIUM; SULBACTAM SODIUM 100; 50 mg/mL; mg/mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC] N 20181231 67457-675_949c5fb9-16ae-42d2-9834-acde4f64c2a1 67457-675 HUMAN PRESCRIPTION DRUG Miacalcin calcitonin salmon INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20160916 NDA NDA017808 Mylan Institutional LLC CALCITONIN SALMON 200 [iU]/mL Calcitonin [Chemical/Ingredient],Calcitonin [EPC] N 20181231 67457-693_f0c15d1d-809a-4eaf-b2b4-5d58e2898276 67457-693 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20160609 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 2.5 mg/.5mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 67457-694_f0c15d1d-809a-4eaf-b2b4-5d58e2898276 67457-694 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20160609 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 5 mg/.4mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 67457-695_f0c15d1d-809a-4eaf-b2b4-5d58e2898276 67457-695 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20160609 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 7.5 mg/.6mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 67457-696_f0c15d1d-809a-4eaf-b2b4-5d58e2898276 67457-696 HUMAN PRESCRIPTION DRUG Fondaparinux Sodium fondaparinux sodium INJECTION, SOLUTION SUBCUTANEOUS 20160609 NDA NDA021345 Mylan Institutional LLC FONDAPARINUX SODIUM 10 mg/.8mL Factor Xa Inhibitor [EPC],Factor Xa Inhibitors [MoA] N 20181231 67457-698_030be999-12fa-4de5-917d-60f57f9b155c 67457-698 HUMAN PRESCRIPTION DRUG Atracurium Besylate atracurium besylate INJECTION, SOLUTION INTRAVENOUS 20171019 ANDA ANDA206096 Mylan Institutional LLC ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 67457-699_5c7dd3c6-8a9a-4b0b-ad02-d560a191ab80 67457-699 HUMAN PRESCRIPTION DRUG Atracurium Besylate atracurium besylate INJECTION, SOLUTION INTRAVENOUS 20171019 ANDA ANDA206001 Mylan Institutional LLC ATRACURIUM BESYLATE 10 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 67457-778_793c75eb-dd65-4b6d-ac46-6e57ce1334f7 67457-778 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim sulfamethoxazole and trimethoprim INJECTION INTRAVENOUS 20171027 ANDA ANDA206607 Mylan Institutional LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 80; 16 mg/mL; mg/mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 67457-779_793c75eb-dd65-4b6d-ac46-6e57ce1334f7 67457-779 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim sulfamethoxazole and trimethoprim INJECTION INTRAVENOUS 20171027 ANDA ANDA206607 Mylan Institutional LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 80; 16 mg/mL; mg/mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 67457-790_7c470364-d9f1-4e51-a62d-2bc9b8760694 67457-790 HUMAN PRESCRIPTION DRUG levetiracetam levetiracetam INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170724 ANDA ANDA203308 Mylan Institutional LLC LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67457-814_e8423a25-dcb6-483f-942f-a5978d0bb9c1 67457-814 HUMAN PRESCRIPTION DRUG Clindamycin Clindamycin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171129 ANDA ANDA204748 Mylan Institutional LLC CLINDAMYCIN 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 67457-815_e8423a25-dcb6-483f-942f-a5978d0bb9c1 67457-815 HUMAN PRESCRIPTION DRUG Clindamycin Clindamycin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171129 ANDA ANDA204748 Mylan Institutional LLC CLINDAMYCIN 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 67457-816_e8423a25-dcb6-483f-942f-a5978d0bb9c1 67457-816 HUMAN PRESCRIPTION DRUG Clindamycin Clindamycin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171129 ANDA ANDA204748 Mylan Institutional LLC CLINDAMYCIN 150 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 67457-831_b7addcf6-fec7-4947-bc27-79ee4e89d231 67457-831 HUMAN PRESCRIPTION DRUG Caspofungin acetate Caspofungin acetate INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170929 ANDA ANDA207650 Mylan Institutional LLC CASPOFUNGIN ACETATE 5 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 67457-832_b7addcf6-fec7-4947-bc27-79ee4e89d231 67457-832 HUMAN PRESCRIPTION DRUG Caspofungin acetate Caspofungin acetate INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20171115 ANDA ANDA207650 Mylan Institutional LLC CASPOFUNGIN ACETATE 7 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 67457-844_6802ea00-2f52-4137-8f2f-0dbf1052ebc0 67457-844 HUMAN PRESCRIPTION DRUG Sodium Phenylacetate and Sodium Benzoate Sodium Phenylacetate and Sodium Benzoate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170523 ANDA ANDA208521 Mylan Institutional LLC SODIUM PHENYLACETATE; SODIUM BENZOATE 100; 100 mg/mL; mg/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 67457-856_a01ed140-f5e0-4e66-921b-babf626ad353 67457-856 HUMAN PRESCRIPTION DRUG Adenosine adenosine INJECTION, SOLUTION INTRAVENOUS 20140328 ANDA ANDA090212 Mylan Institutional LLC ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 67457-857_a01ed140-f5e0-4e66-921b-babf626ad353 67457-857 HUMAN PRESCRIPTION DRUG Adenosine adenosine INJECTION, SOLUTION INTRAVENOUS 20140328 ANDA ANDA090212 Mylan Institutional LLC ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 67457-886_1663b15d-8298-4d47-82d9-51515b16eaa0 67457-886 HUMAN PRESCRIPTION DRUG Hydroxyprogesterone Caproate Hydroxyprogesterone Caproate INJECTION INTRAMUSCULAR 20170922 ANDA ANDA200271 Mylan Institutional LLC HYDROXYPROGESTERONE CAPROATE 250 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 67457-893_9955aced-ac32-43e6-b39a-c6c023a50dc3 67457-893 HUMAN PRESCRIPTION DRUG Busulfan Busulfan INJECTION INTRAVENOUS 20171121 ANDA ANDA208536 Mylan Institutional LLC BUSULFAN 6 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 67465-0001_e6aa8897-c0c7-4676-8618-5cd6b107e37f 67465-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20051001 UNAPPROVED MEDICAL GAS Mt. Vernon Community Pharmacy, Inc. d/b/a The Medicine Shoppe OXYGEN 99 L/100L E 20171231 67467-182_aae10ecc-a31e-d699-eff2-7540089705c4 67467-182 PLASMA DERIVATIVE Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human) von Willebrand Factor/Coagulation Factor VIII Complex (Human) POWDER, FOR SOLUTION INTRAVENOUS 20091204 BLA BLA125251 Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. ANTIHEMOPHILIC FACTOR HUMAN; VON WILLEBRAND FACTOR HUMAN 100; 100 [iU]/mL; [iU]/mL Human Antihemophilic Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Factor VIII [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Platelet Aggregation [PE],Increased Coagulation Activity [PE],von Willebrand Factor [Chemical/Ingredient],Blood Coagulation Factors [Chemical/Ingredient] E 20171231 67467-623_0115cedc-4781-0619-f8c9-82e8199df443 67467-623 HUMAN PRESCRIPTION DRUG Albumin (Human) Albumin Human SOLUTION INTRAVENOUS 20061017 BLA BLA125154 Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. ALBUMIN (HUMAN) 50 g/1000mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] E 20171231 67467-633_7fc09e55-b28d-9197-a808-a6b341102f06 67467-633 HUMAN PRESCRIPTION DRUG Albumin (Human) Albumin Human SOLUTION INTRAVENOUS 20061017 BLA BLA125154 Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. ALBUMIN (HUMAN) 200 g/1000mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] E 20171231 67467-643_be20e36e-0b6e-7b05-82ac-7078b2befd03 67467-643 HUMAN PRESCRIPTION DRUG Albumin (Human) Albumin Human SOLUTION INTRAVENOUS 20061017 BLA BLA125154 Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. ALBUMIN (HUMAN) 250 g/1000mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] E 20171231 67467-843_0fe33130-c3e4-4baa-db1f-4ce138e6c2e5 67467-843 HUMAN PRESCRIPTION DRUG Octagam Immune Globulin (Human) Immune Globulin SOLUTION INTRAVENOUS 20040521 BLA BLA125062 Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. HUMAN IMMUNOGLOBULIN G 50 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] E 20171231 67473-103_07e06871-2141-46b7-84b2-dbd169c52128 67473-103 HUMAN OTC DRUG SHENG CHUN HERBAL Pain Relieving MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part348 Sheng Chun Tang Pharmaceutical Industrial Co., Ltd MENTHOL; METHYL SALICYLATE .05; .01 g/g; g/g N 20181231 67473-500_f35a85d4-1da9-4907-9723-4173f0816864 67473-500 HUMAN OTC DRUG SHENG CHUN PAIN RELIEF CAMPHOR (NATURAL), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE OINTMENT TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part348 Sheng Chun Tang Pharmaceutical Industrial Co. Ltd CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .06; .02; .02 g/g; g/g; g/g N 20181231 67475-112_1934f220-5c1d-4b0a-b5cf-f3e98c672542 67475-112 HUMAN OTC DRUG Golden Sunshine Far Infrared HOT Herbal Topical Analgesic PATCH TOPICAL 20040802 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .03; .005 g/g; g/g E 20171231 67475-114_5d9674de-4b4e-4313-8b77-7672277ace5c 67475-114 HUMAN OTC DRUG Golden Sunshine Herbal Topical Analgesic SPRAY TOPICAL 20040802 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .00781; .03 g/g; g/g E 20171231 67475-123_29fe4406-528a-4b2d-be62-2e2438bf80f2 67475-123 HUMAN OTC DRUG Golden Sunshine Herbal Topical Analgesic CREAM TOPICAL 20100615 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .02; .005 g/g; g/g E 20171231 67475-211_f3b7da5b-8739-4014-9d29-a3e2443c8176 67475-211 HUMAN OTC DRUG Golden Sunshine Far Infrared Herbal Topical Analgesic PASTE TOPICAL 20090223 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .03; .03 g/g; g/g E 20171231 67475-212_c8e34306-2e3f-43f7-a790-6a6336df24e9 67475-212 HUMAN OTC DRUG Golden Sunshine Far Infrared COOL Herbal Topical Analgesic PATCH TOPICAL 20040802 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .03; .005 g/g; g/g E 20171231 67475-312_a2e6005a-a1c9-4a2a-b692-b16147a7f461 67475-312 HUMAN OTC DRUG PAIN Terminator Analgesic Topical Analgesic PATCH TOPICAL 20060518 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .03; .005 g/g; g/g E 20171231 67475-313_8965c3b0-43ac-400d-b41d-a6e52dff29a3 67475-313 HUMAN OTC DRUG PAIN Terminator Analgesic Topical Analgesic CREAM TOPICAL 20090223 OTC MONOGRAPH NOT FINAL part348 Golden Sunshine International, Inc. MENTHOL; METHYL SALICYLATE .02; .005 g/g; g/g E 20171231 67490-0001_1ba22c62-74c2-42de-aec3-a4eff6f8a1ea 67490-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091112 UNAPPROVED MEDICAL GAS Scott Medical Supply Inc. OXYGEN 99 L/100L E 20171231 67491-7777_21091b5b-5aee-4e6f-ae8b-f067b107d9db 67491-7777 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20021015 UNAPPROVED MEDICAL GAS Med-Core Services, Inc. OXYGEN 99 L/100L E 20171231 67492-104_5d8f0b70-69e2-45ce-e053-2a91aa0acb8b 67492-104 HUMAN OTC DRUG Calmol 4 Zinc Oxide and Cocoa Butter SUPPOSITORY RECTAL 20060513 OTC MONOGRAPH FINAL part346 Resical Inc. ZINC OXIDE; COCOA BUTTER 270; 2052 mg/1; mg/1 N 20181231 67492-105_c98f421e-503e-42f2-83ba-77bbb5870239 67492-105 HUMAN OTC DRUG Resinol PETROLATUM and RESORCINOL OINTMENT TOPICAL 20020629 OTC MONOGRAPH NOT FINAL part348 ResiCal, Inc. PETROLATUM; RESORCINOL 55; 2 g/100g; g/100g E 20171231 67493-0009_5f396ef0-7a2f-4caa-89f2-820b0c986967 67493-0009 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020926 UNAPPROVED MEDICAL GAS Buckeye Home Health Center, Inc. OXYGEN 99 L/100L E 20171231 67502-391_e61795c9-ae41-4d87-811a-7b6dd26717b7 67502-391 HUMAN OTC DRUG Clearly Better Foaming Hand Sanitizer LIQUID TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part333A Intercon Chemical Company BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 67502-447_eac3efbf-a158-4986-8219-9e60f5c49f39 67502-447 HUMAN OTC DRUG Moisturizing Hand Sanitizer Ethyl Alcohol LOTION TOPICAL 20160909 OTC MONOGRAPH NOT FINAL part333A INTERCON CHEMICAL CO ALCOHOL .62 mL/mL N 20181231 67502-460_3c537807-3577-4505-bc38-9d861c816b45 67502-460 HUMAN OTC DRUG Antibacterial Hand Wash Benzalkonium chloride 0.13% LIQUID TOPICAL 20160908 OTC MONOGRAPH NOT FINAL part333A Intercon Chemical Co. BENZALKONIUM CHLORIDE 1.313 mg/mL N 20181231 67502-960_6cab4ff3-c5af-48c1-a540-1e883dab1a7a 67502-960 HUMAN OTC DRUG Clearly Better Alcohol LIQUID TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Intercon Chemical Company ALCOHOL 63 mg/mL N 20181231 67502-961_b4bb5505-88a7-4992-9772-6e4297fea865 67502-961 HUMAN OTC DRUG Moisturizing Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part333A Intercon Chemical Company BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 67510-0005_58253067-9740-74d3-e053-2a91aa0adbec 67510-0005 HUMAN OTC DRUG Muscle and Joint Menthol GEL TOPICAL 20110811 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 2.5 g/100g N 20181231 67510-0008_7238bb4f-cde7-4a16-b0f3-51faa9b9c67b 67510-0008 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20111123 OTC MONOGRAPH FINAL part343 Kareway Product, Inc. ASPIRIN 325 mg/1 E 20171231 67510-0011_11323c7e-ab6e-447c-9cfe-68aed7a5e7bb 67510-0011 HUMAN OTC DRUG Mint Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110815 OTC MONOGRAPH FINAL part355 Kareway Product, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 67510-0012_3d1c92e6-ae26-4e8c-90c4-c8cea73322f4 67510-0012 HUMAN OTC DRUG Regular Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110815 OTC MONOGRAPH FINAL part355 Kareway Product, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g E 20171231 67510-0016_b1933159-1485-4898-b563-61e4efece407 67510-0016 HUMAN OTC DRUG Antibacterial Gold Triclocarban SOAP TOPICAL 20110907 OTC MONOGRAPH NOT FINAL part333E Kareway Product, Inc. TRICLOCARBAN .1 g/100g E 20171231 67510-0017_e785d52c-f47a-4a29-bad1-5d44c0bfe09c 67510-0017 HUMAN OTC DRUG Antibacterial Beauty Triclocarban SOAP TOPICAL 20110907 OTC MONOGRAPH NOT FINAL part333E Kareway Product, Inc. TRICLOCARBAN .1 g/100g E 20171231 67510-0026_7e224d37-7b46-4440-a283-d6b8b79f0bcd 67510-0026 HUMAN OTC DRUG Medicated Pain Relief Hot Menthol, Capsicum extract PATCH TOPICAL 20110916 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL; CAPSICUM OLEORESIN 29.44; .166 mg/1; mg/1 N 20181231 67510-0030_3bf2a113-3f2a-3b42-e054-00144ff88e88 67510-0030 HUMAN OTC DRUG Cold and Hot Pain Relief Menthol PATCH TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 400 mg/1 N 20181231 67510-0043_feae241c-d9a2-4328-99bc-7a7e50e3b8d4 67510-0043 HUMAN OTC DRUG Pine Salt Sodium Fluoride PASTE, DENTIFRICE DENTAL 20110822 OTC MONOGRAPH FINAL part355 Kareway Product, Inc. SODIUM FLUORIDE 2.2 mg/g E 20171231 67510-0054_615afe0d-b54c-8efc-e053-2991aa0ab306 67510-0054 HUMAN OTC DRUG Anti Itch Diphenhydramine HCl, Zinc acetate CREAM TOPICAL 20110811 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. ZINC ACETATE; DIPHENHYDRAMINE HYDROCHLORIDE .1; 2 g/100g; g/100g N 20191231 67510-0055_64e859d4-1ed6-4b9f-9dbe-dd45ef7aa1b2 67510-0055 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20120724 OTC MONOGRAPH FINAL part333B Kareway Product, Inc. BACITRACIN ZINC 500 [USP'U]/g E 20171231 67510-0056_34a8ecee-2848-4827-9b4e-910a7aaed43d 67510-0056 HUMAN OTC DRUG Hemorrhoidal MINERAL OIL,PETROLATUM,PHENYLEPHRINE OINTMENT TOPICAL 20120702 OTC MONOGRAPH FINAL part346 Kareway Product, Inc. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 71.9; .25 g/100g; g/100g; g/100g E 20171231 67510-0057_55147dfd-21d5-6ba4-e054-00144ff8d46c 67510-0057 HUMAN OTC DRUG Tolnaftate Tolnaftate CREAM TOPICAL 20110811 OTC MONOGRAPH FINAL part333C Kareway Product, Inc. TOLNAFTATE 1 g/100g N 20181231 67510-0058_615afe0d-b55d-8efc-e053-2991aa0ab306 67510-0058 HUMAN OTC DRUG Oral Pain Relief Oral Pain Reliever GEL TOPICAL 20110717 OTC MONOGRAPH NOT FINAL part356 Kareway Product, Inc. BENZOCAINE 200 mg/g N 20181231 67510-0062_a316a6dd-c83c-4cd7-a0d5-4a169c4c3ab9 67510-0062 HUMAN OTC DRUG Redness reliever tetrahydrozoline HCl LIQUID OPHTHALMIC 20110811 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. TETRAHYDROZOLINE HYDROCHLORIDE .5 mg/mL N 20181231 67510-0063_82004441-694e-44b1-ba1d-75b159ed8d1b 67510-0063 HUMAN OTC DRUG Tears lubricant glycerin, hypromelloses, polyethylene glycol 400 LIQUID OPHTHALMIC 20100829 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 2; 10 mg/mL; mg/mL; mg/mL N 20181231 67510-0064_fbe34271-e49c-48b2-adfe-406f104cd300 67510-0064 HUMAN OTC DRUG Advanced relief dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl LIQUID OPHTHALMIC 20110811 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. TETRAHYDROZOLINE HYDROCHLORIDE; DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE .5; 1; 10; 10 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67510-0065_553d060d-92c5-18b8-e054-00144ff88e88 67510-0065 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. HYDROCORTISONE 1 h/100g N 20181231 67510-0066_56ff4b98-b507-39cb-e054-00144ff8d46c 67510-0066 HUMAN OTC DRUG Antibiotic Neomycin Sulfate OINTMENT TOPICAL 20110811 OTC MONOGRAPH FINAL part333B Kareway Product, Inc. NEOMYCIN SULFATE 3.5 mg/g N 20181231 67510-0068_4a15092f-2939-6980-e054-00144ff88e88 67510-0068 HUMAN OTC DRUG Nasal Decongestant Oxymetazoline HCl SPRAY NASAL 20110812 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 67510-0069_91f22696-59ac-49b1-8356-7407295fb60d 67510-0069 HUMAN OTC DRUG Nasal Decongestant Extra Moisturizing Oxymetazoline HCl SPRAY NASAL 20110812 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 67510-0070_4d4d5279-f24f-47b4-aac0-79fef99b7006 67510-0070 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20110810 OTC MONOGRAPH FINAL part333B Kareway Product, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g E 20171231 67510-0081_5a3614de-f22b-5591-e053-2991aa0a8e74 67510-0081 HUMAN OTC DRUG Face and Body Sunscreen Octinoxate and Titanium dioxide LOTION TOPICAL 20130124 OTC MONOGRAPH NOT FINAL part352 Kareway Product, Inc. OCTINOXATE; TITANIUM DIOXIDE 7; 2.8 g/100mL; g/100mL N 20181231 67510-0082_5a35ee5e-7c0b-976f-e053-2991aa0af5f0 67510-0082 HUMAN OTC DRUG Kids Sunscreen Octinoxate and Titanium Dioxide LOTION TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part352 Kareway Product, Inc. OCTINOXATE; TITANIUM DIOXIDE 7; 2.8 g/100mL; g/100mL N 20181231 67510-0083_5a3617ea-0d9a-67a7-e053-2a91aa0ad7f0 67510-0083 HUMAN OTC DRUG Sport Sunblock Octinoxate and Titanium Dioxide LOTION TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part352 Kareway Product, Inc. OCTINOXATE; TITANIUM DIOXIDE 7; 2.8 g/100mL; g/100mL N 20181231 67510-0085_812af3dc-733f-4833-bb37-c7fab12e8827 67510-0085 HUMAN OTC DRUG Cold and Hot Pain Relief Sleeve Menthol PATCH TOPICAL 20120419 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 400 mg/1 N 20181231 67510-0111_56e93b67-6065-5ae2-e054-00144ff88e88 67510-0111 HUMAN OTC DRUG Mint Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110815 OTC MONOGRAPH FINAL part355 Kareway Product, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 67510-0112_56e9211f-1080-3aab-e054-00144ff8d46c 67510-0112 HUMAN OTC DRUG Regular Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110815 OTC MONOGRAPH FINAL part355 Kareway Product, Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 67510-0126_5f52a17f-00a4-754e-e053-2991aa0aabfd 67510-0126 HUMAN OTC DRUG Medicated Pain Relief Hot Menthol, Capsicum extract PATCH TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL; CAPSAICIN 24; .12 mg/1; mg/1 N 20181231 67510-0152_84eeab00-7b87-4312-b172-a645485b3b69 67510-0152 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110811 OTC MONOGRAPH NOT FINAL part343 Kareway Product, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 67510-0153_84eeab00-7b87-4312-b172-a645485b3b69 67510-0153 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20110811 OTC MONOGRAPH NOT FINAL part343 Kareway Product, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 67510-0154_d2524712-3485-4e1c-9e7b-2cd5bc8df6fc 67510-0154 HUMAN OTC DRUG Acetaminophen PM Acetaminophen, diphenhydramine HCl TABLET ORAL 20110128 OTC MONOGRAPH NOT FINAL part343 Kareway Product, Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 67510-0156_ee1471a9-f299-4373-8754-a1acca87d16a 67510-0156 HUMAN OTC DRUG Multi Sympton Cold Day Night Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20120501 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. E 20171231 67510-0158_55dc0484-2c66-4aed-a077-4b78f92d4810 67510-0158 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 20110818 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 67510-0159_1cf99cf6-1836-4888-a5cc-f7ea5c6bb5f0 67510-0159 HUMAN OTC DRUG Allergy Relief CHLORPHENIRAMINE MALEATE TABLET ORAL 20110818 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 67510-0160_5e9a6c00-38aa-4e50-aa1e-f67f20f15e8b 67510-0160 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET ORAL 20110818 OTC MONOGRAPH FINAL part338 Kareway Product, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 67510-0170_641dd840-511e-43eb-e053-2991aa0a2e0f 67510-0170 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20110810 OTC MONOGRAPH FINAL part333B Kareway Product, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20191231 67510-0171_786f3341-b5f3-496b-b249-7f935f8445c6 67510-0171 HUMAN OTC DRUG Gentle Laxative BIisacodyl TABLET, COATED ORAL 20120215 OTC MONOGRAPH NOT FINAL part334 Kareway Product, Inc. BISACODYL 5 mg/1 E 20171231 67510-0172_a16753f1-eb22-4488-9d22-a954c1cc4a13 67510-0172 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20120901 OTC MONOGRAPH FINAL part332 Kareway Product, Inc. DIMETHICONE 125 mg/1 E 20171231 67510-0251_9eb88e7a-f54f-4a8f-a3aa-feeebbc88f61 67510-0251 HUMAN OTC DRUG Alcohol Prep Pads isopropyl alcohol SWAB TOPICAL 20130820 OTC MONOGRAPH NOT FINAL part333A Kareway Product, Inc. ISOPROPYL ALCOHOL 70 1/1 E 20171231 67510-0300_4d60ba9e-c512-1d3f-e054-00144ff8d46c 67510-0300 HUMAN OTC DRUG Cold and Hot Pain Relief Menthol PATCH TOPICAL 20170221 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 400 mg/1 N 20181231 67510-0301_cfd90953-404e-4944-8126-5a6406fb640c 67510-0301 HUMAN OTC DRUG Medicated Pain Relief Menthol PATCH TOPICAL 20110912 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 428.5 mg/1 N 20181231 67510-0302_2456d211-71f9-4ce6-8a21-add3a15b040d 67510-0302 HUMAN OTC DRUG Medicated Pain Relief Menthol PATCH TOPICAL 20110907 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 428.5 mg/1 N 20181231 67510-0303_32c033cf-319f-4e39-bf43-4bcc985a56ba 67510-0303 HUMAN OTC DRUG Capsaicin Pain Relief Capsaicin PATCH TOPICAL 20120123 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. CAPSAICIN .702 mg/1 N 20181231 67510-0305_5f9cfed0-1b1e-46a2-e053-2991aa0aca8a 67510-0305 HUMAN OTC DRUG Pain Relief DL-Camphor, L-Menthol, Methyl Salicylate patch PATCH TOPICAL 20120125 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE .4; 1.8; 2 mg/1; mg/1; mg/1 N 20181231 67510-0378_615e314b-120f-4a88-e053-2a91aa0a8cb4 67510-0378 HUMAN OTC DRUG Tinted BB Octinoxate and Titanium dioxide CREAM TOPICAL 20131011 OTC MONOGRAPH FINAL part352 Kareway Product, Inc. OCTINOXATE; TITANIUM DIOXIDE 6; 8.5 mg/100mg; mg/100mg N 20181231 67510-0487_16bde801-42e2-4993-bebf-1a26e18394e1 67510-0487 HUMAN OTC DRUG Hand Sanitizer ALCOHOL GEL TOPICAL 20131007 OTC MONOGRAPH NOT FINAL part333E Kareway Product, Inc. ALCOHOL 62 mL/100mL N 20181231 67510-0501_e1147c11-b7c7-4426-8dae-835da9205faa 67510-0501 HUMAN OTC DRUG Night Time Cold/Flu Relief Original Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110826 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL E 20171231 67510-0502_58252f15-486b-3061-e053-2a91aa0a2320 67510-0502 HUMAN OTC DRUG Diaper Rash Zinc Oxide CREAM TOPICAL 20110825 OTC MONOGRAPH FINAL part347 Kareway Product, Inc. ZINC OXIDE .1 g/g N 20181231 67510-0503_fb220855-dc51-43cf-8a9b-f04ed170a667 67510-0503 HUMAN OTC DRUG Night Time Cough Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120711 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 6.25 mg/15mL; mg/15mL E 20171231 67510-0505_1a79d259-9965-4ace-ad33-2bc01ba8f2ec 67510-0505 HUMAN OTC DRUG Pink Bismuth Bismuth Subsalicylate LIQUID ORAL 20110829 OTC MONOGRAPH FINAL part335 Kareway Product, Inc. BISMUTH SUBSALICYLATE 262 mg/15mL E 20171231 67510-0506_e039c466-6788-4aaf-b15b-275c2cfe796e 67510-0506 HUMAN OTC DRUG Tussin CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20110826 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 67510-0507_6038afb7-254e-4b5c-b586-f5833c75c8d3 67510-0507 HUMAN OTC DRUG Night Time Cold/Flu Relief Cherry Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20110826 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 500; 15; 6.25 mg/15mL; mg/15mL; mg/15mL E 20171231 67510-0508_b9c37609-fab1-48bc-b9a2-64c67e9760d4 67510-0508 HUMAN OTC DRUG Childrens Non Aspirin Acetaminophen LIQUID ORAL 20110902 OTC MONOGRAPH NOT FINAL part343 Kareway Product, Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 67510-0521_9ea99d30-2c01-4899-8557-55ff3710818d 67510-0521 HUMAN OTC DRUG Night Time Gelcap Acetaminophen, Dextromethorphan, Doxylamine CAPSULE, LIQUID FILLED ORAL 20110601 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 67510-0523_57c0ea57-c0f3-48e1-a8bd-834047b7f839 67510-0523 HUMAN OTC DRUG Day Time Gelcap Acetaminophen, Dextromethorphan, Phenylephrine CAPSULE, LIQUID FILLED ORAL 20110601 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 67510-0526_0d5c9dfc-7adc-499d-8da9-0ccd034826bb 67510-0526 HUMAN OTC DRUG Tussin Chest Guaifenesin LIQUID ORAL 20110829 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. GUAIFENESIN 100 mg/5mL E 20171231 67510-0527_c9e1677e-3bca-499d-beb1-309aeb11bd0b 67510-0527 HUMAN OTC DRUG Tussin DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20110826 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 67510-0544_f32e3302-f170-4be8-a351-8b383d43052d 67510-0544 HUMAN OTC DRUG Day Time Cold/Flu Relief Acetaminophen, Dextromethorphan, Phenylephrine LIQUID ORAL 20110906 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL E 20171231 67510-0557_4294707b-3c0b-4a75-96e0-61a18ba498d7 67510-0557 HUMAN OTC DRUG Nighttime Sleepaid Diphenhydramine Hydrochloride CAPSULE, GELATIN COATED ORAL 20141022 OTC MONOGRAPH FINAL part338 Kareway Product, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/21 E 20171231 67510-0631_4bea247a-8830-648d-e054-00144ff8d46c 67510-0631 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20131212 OTC MONOGRAPH FINAL part333B Kareway Product, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 67510-0632_4bea247a-8847-648d-e054-00144ff8d46c 67510-0632 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. HYDROCORTISONE 1 g/100g N 20181231 67510-0633_615e11fe-e217-2a2d-e053-2a91aa0a54b0 67510-0633 HUMAN OTC DRUG Anti-Itch Diphenhydramine HCl, Zinc acetate CREAM TOPICAL 20131213 OTC MONOGRAPH FINAL part347 Kareway Product, Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 67510-0634_615e11fe-e225-2a2d-e053-2a91aa0a54b0 67510-0634 HUMAN OTC DRUG Muscle and Joint Menthol GEL TOPICAL 20131212 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL 2.5 g/100g N 20181231 67510-0657_54143236-dd40-4f00-8d3f-6db2e3408e2e 67510-0657 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20110811 OTC MONOGRAPH FINAL part333C Kareway Product, Inc. CLOTRIMAZOLE 1 g/100g E 20171231 67510-0659_56fed82c-69d6-2547-e054-00144ff88e88 67510-0659 HUMAN OTC DRUG Muscle Rub Ultra Camphor,Menthol, methyl salicylate CREAM TOPICAL 20110811 OTC MONOGRAPH NOT FINAL part348 Kareway Product, Inc. MENTHOL; MENTHYL SALICYLATE, (+/-)-; CAMPHOR (NATURAL) 10; 30; 4 g/100g; g/100g; g/100g N 20181231 67510-0662_9d3e152e-0ec1-4aa1-bcbe-0c413abfc2e0 67510-0662 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20110908 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. WATER 99.05 mL/100mL N 20181231 67510-0663_2a1549eb-704f-42ed-a54c-d73147215fba 67510-0663 HUMAN OTC DRUG Eye Lubricant polyethylene gloycol, propylene glycol LIQUID OPHTHALMIC 20121001 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 67510-0663_672d04af-0109-4b06-91f9-d98861679f06 67510-0663 HUMAN OTC DRUG Eye Lubricant polyethylene gloycol, propylene glycol LIQUID OPHTHALMIC 20120111 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 67510-0665_197ee658-8541-41eb-89a3-7db6da809652 67510-0665 HUMAN OTC DRUG Seasonal itchy and Red eye relief tetrahydrozoline HCl, Zinc sulfate LIQUID OPHTHALMIC 20131112 OTC MONOGRAPH FINAL part349 Kareway Product, Inc. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE .05; .25 mg/mL; mg/mL N 20181231 67510-0667_1131c892-2a86-4409-ba5d-39113222a3ee 67510-0667 HUMAN OTC DRUG Saline Nasal Sodium chloride SPRAY NASAL 20110207 UNAPPROVED DRUG OTHER Kareway Product, Inc. SODIUM CHLORIDE 6.5 mg/mL N 20181231 67510-0669_2540f74a-1312-47e0-e054-00144ff8d46c 67510-0669 HUMAN OTC DRUG Nasal Decongestant Oxymetazoline HCl SPRAY NASAL 20151123 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20181231 67510-0670_969a2577-ac11-4818-a76d-eb0dc7323612 67510-0670 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20110912 OTC MONOGRAPH FINAL part333B Kareway Product, Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g E 20171231 67510-0672_8ed606be-41ee-42b4-a48d-260740d367e5 67510-0672 HUMAN OTC DRUG Vaporizing Chest Rub Camphor, Eucalyptus Oil, Menthol GEL TOPICAL 20110909 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.8; 1; 1.2 g/100g; g/100g; g/100g N 20181231 67510-0888_19c5a7a3-d382-6f73-e054-00144ff8d46c 67510-0888 HUMAN OTC DRUG Wet Wipes Benzethonium Chloride SWAB TOPICAL 20150630 OTC MONOGRAPH NOT FINAL part333A Kareway Product, Inc. BENZETHONIUM CHLORIDE .3 1/1001 E 20171231 67510-1501_489bf408-8a99-488b-b6ec-3901d8e9b3b5 67510-1501 HUMAN OTC DRUG Night Time Cold/Flu Relief Original Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120730 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL E 20171231 67510-1507_649e7b4c-23a5-4b95-8947-6a0afaa3701c 67510-1507 HUMAN OTC DRUG Night Time Cold/Flu Relief Cherry Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20120711 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL E 20171231 67510-1561_704ed99a-5917-4bcc-a9ed-7a195f013060 67510-1561 HUMAN OTC DRUG Night Time Cold/Flu Relief Cherry Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20131212 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL E 20171231 67510-1562_d56b2225-d9de-4cca-8e6b-310a344a0b85 67510-1562 HUMAN OTC DRUG Night Time Cold/Flu Relief Original Acetaminophen, Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20131212 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL E 20171231 67510-1670_5542da3f-5960-0612-e054-00144ff8d46c 67510-1670 HUMAN OTC DRUG Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20170726 OTC MONOGRAPH FINAL part333B Kareway Product, Inc. NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; BACITRACIN ZINC; POLYMYXIN B SULFATE 3.5; 10; 500; 10000 mg/g; mg/g; [iU]/g; [iU]/g N 20181231 67510-9156_ee1471a9-f299-4373-8754-a1acca87d16a 67510-9156 HUMAN OTC DRUG Multi Sympton Cold Day Night Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT 20120501 OTC MONOGRAPH FINAL part341 Kareway Product, Inc. E 20171231 67516-0107_4eb687fd-6368-2f13-e054-00144ff88e88 67516-0107 HUMAN OTC DRUG Cortibalm Hydrocortisone Lip Balm OINTMENT TOPICAL 20010110 OTC MONOGRAPH NOT FINAL part348 Dr. Dan's LLC HYDROCORTISONE 100 g/g N 20181231 67525-100_4f0efc29-e020-42f3-867b-79fd2c3a7b36 67525-100 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20050101 NDA NDA206023 Spectrum Gas Products, Inc OXYGEN 99 L/100L N 20191231 67536-223_a9833cba-2a70-4a84-bde1-37e5452e7110 67536-223 HUMAN OTC DRUG Absorbine BACK Therapeutic Pain Relief MENTHOL PATCH TOPICAL 20131010 OTC MONOGRAPH NOT FINAL part348 Teh Seng Pharmaceutical Mfg. Co., Ltd. MENTHOL 5 g/100g N 20181231 67536-882_a2c1addd-a9d9-494e-b63d-fd26559bac2a 67536-882 HUMAN OTC DRUG QUALI HERBAL MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20131010 OTC MONOGRAPH NOT FINAL part348 Teh Seng Pharmaceutical Mfg. Co., Ltd MENTHOL; METHYL SALICYLATE 10; .5 g/100g; g/100g N 20181231 67536-883_9ec799be-7ea0-48f4-b503-c9d1c62bb1c3 67536-883 HUMAN OTC DRUG QUALI WARM MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20131010 OTC MONOGRAPH NOT FINAL part348 Teh Seng Pharmaceutical Mfg. Co., Ltd MENTHOL; METHYL SALICYLATE 3; .8 g/100g; g/100g N 20181231 67536-884_f97cbc68-a049-463e-8907-3ba503cdaea7 67536-884 HUMAN OTC DRUG QUALI COLD MENTHOL PATCH TOPICAL 20131010 OTC MONOGRAPH NOT FINAL part348 Teh Seng Pharmaceutical Mfg. Co., Ltd METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 2; 1; .5 g/100g; g/100g; g/100g N 20181231 67542-010_31aef1dd-2dcc-42fc-b46b-c80a66bf8bbd 67542-010 HUMAN OTC DRUG BAUME PRODIGIEUX LEVRES 01 NATURAL CRYSTAL NUTRI-PROTECTING LIP CARE SPF 15 OCTINOXATE, AVOBENZONE LIPSTICK TOPICAL 20060501 OTC MONOGRAPH FINAL part352 LABORATOIRE NUXE OCTINOXATE; AVOBENZONE 7.3; 2.9 mL/100mL; mL/100mL E 20171231 67542-020_7309b478-33c8-40f5-b1bb-90b6e38533b8 67542-020 HUMAN OTC DRUG BAUME PRODIGIEUX LEVRES 02 LEGENDAIRE PINK NUTRI-PROTECTING LIP CARE SPF 15 OCTINOXATE, AVOBENZONE LIPSTICK TOPICAL 20070501 OTC MONOGRAPH FINAL part352 LABORATOIRE NUXE OCTINOXATE; AVOBENZONE 7.3; 2.9 mL/100mL; mL/100mL E 20171231 67542-030_4d11554a-6806-4a8c-a161-5c9cdd83cdfa 67542-030 HUMAN OTC DRUG BAUME PRODIGIEUX LEVRES 03 SHIMMERING CHOCOLATE NUTRI-PROTECTING LIP CARE SPF 15 OCTINOXATE, AVOBENZONE LIPSTICK TOPICAL 20070501 OTC MONOGRAPH FINAL part352 LABORATOIRE NUXE OCTINOXATE; AVOBENZONE 7.3; 2.9 mL/100mL; mL/100mL E 20171231 67542-040_c449bdb6-5d09-4d64-81a4-edbef8b8feb3 67542-040 HUMAN OTC DRUG BAUME PRODIGIEUX LEVRES 04 RED CHARISMATIC NUTRI-PROTECTING LIP CARE SPF 15 OCTINOXATE, AVOBENZONE LIPSTICK TOPICAL 20090401 OTC MONOGRAPH FINAL part352 LABORATOIRE NUXE OCTINOXATE; AVOBENZONE 7.3; 2.9 mL/100mL; mL/100mL E 20171231 67544-001_90f66ef7-4b4c-4386-a1fa-56d0cbc08d1e 67544-001 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 15 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 67544-002_90f66ef7-4b4c-4386-a1fa-56d0cbc08d1e 67544-002 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 67544-003_90f66ef7-4b4c-4386-a1fa-56d0cbc08d1e 67544-003 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20110706 ANDA ANDA040419 Aphena Pharma Solutions - Tennessee, LLC ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 67544-005_02a9e5f5-eeaf-49fa-b28d-1b1f560ea902 67544-005 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Aphena Pharma Solutions - Tennessee, LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-012_97a0746d-58ce-4eab-8a2e-231e6988448c 67544-012 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19970908 ANDA ANDA040245 Aphena Pharma Solutions - Tennessee, LLC CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 67544-019_fe566d09-3b52-4def-901e-a14f3589f799 67544-019 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071135 Aphena Pharma Solutions - Tennessee, LLC DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-020_9286513a-0020-4199-ab54-c5da4831bb64 67544-020 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19870203 ANDA ANDA071136 Aphena Pharma Solutions - Tennessee, LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-021_f2c3a3a3-2b0d-46eb-94fb-2b708690c0eb 67544-021 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20101130 ANDA ANDA085762 Aphena Pharma Solutions - Tennessee, LLC DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 67544-023_5d9e47c2-cf3a-4def-a906-1d7fe00c6620 67544-023 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA089160 Aphena Pharma Solutions - Tennessee, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 67544-024_5d9e47c2-cf3a-4def-a906-1d7fe00c6620 67544-024 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040201 Aphena Pharma Solutions - Tennessee, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 67544-025_5d9e47c2-cf3a-4def-a906-1d7fe00c6620 67544-025 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040201 Aphena Pharma Solutions - Tennessee, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 67544-026_5d9e47c2-cf3a-4def-a906-1d7fe00c6620 67544-026 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040084 Aphena Pharma Solutions - Tennessee, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 650 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 67544-038_100df325-8fc5-4e54-95d9-19c8b1f81a13 67544-038 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071427 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-052_bc534aeb-3ada-4dc5-8d65-d7b321f4b500 67544-052 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 67544-057_31c3f6b2-2ac4-440f-90bc-15aae152d990 67544-057 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20030201 UNAPPROVED DRUG OTHER Aphena Pharma Solutions - Tennessee, Inc. PHENOBARBITAL 32.4 mg/1 CIV N 20181231 67544-060_de793f36-7be2-4f3e-89d9-0db5067cf561 67544-060 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20000407 NDA NDA020702 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67544-061_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-061 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 67544-070_bc534aeb-3ada-4dc5-8d65-d7b321f4b500 67544-070 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 67544-075_ca0bf468-958c-439f-9568-defb902354cf 67544-075 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 67544-078_31bfccac-afec-4ca6-aa1f-024e6e54aff3 67544-078 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950406 ANDA ANDA074132 Aphena Pharma Solutions - Tennessee, LLC NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67544-080_bedd246d-d8fe-4d00-98bd-8042d81f964b 67544-080 HUMAN PRESCRIPTION DRUG Zoloft SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Aphena Pharma Solutions - Tennessee, LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67544-085_0c1f0c4b-ed50-47ad-94a6-98a47ead9315 67544-085 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aphena Pharma Solutions - Tennessee, LLC AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67544-087_74ba9277-cf16-4079-ad5b-b444357bf663 67544-087 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073025 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67544-097_4458c829-ec73-4861-9ff6-3839cdc60643 67544-097 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Aphena Pharma Solutions - Tennessee, LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 67544-102_cb3df109-9a12-43f9-b1dd-99e156d81b11 67544-102 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20110209 NDA NDA019129 Aphena Pharma Solutions - Tennessee, LLC TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67544-106_8eccf91e-8dd6-406a-bfe2-a45d49012d13 67544-106 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Aphena Pharma Solutions - Tennessee, LLC LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67544-117_e3c09b61-e055-476c-b814-9ef152507f28 67544-117 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070102 ANDA ANDA072251 Aphena Pharma Solutions - Tennessee, LLC OXAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-124_655b7e32-c549-4407-8f30-71f63c491361 67544-124 HUMAN PRESCRIPTION DRUG Alprazolam alprazolam TABLET ORAL 20120723 ANDA ANDA074215 Aphena Pharma Solutions - Tennessee, LLC ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-127_1a324c16-932a-45cd-9cb6-0fbe929ae3f1 67544-127 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20121025 ANDA ANDA070920 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-136_349eedc7-991d-4012-9c58-0179f7350568 67544-136 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19870803 ANDA ANDA071638 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-142_3437598f-3128-4bd3-a0e5-f55b485dee04 67544-142 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072928 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-149_cc734890-e42c-454a-b771-3ecd169d161a 67544-149 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20120703 NDA NDA021282 Aphena Pharma Solutions - Tennessee, LLC GUAIFENESIN 600 mg/1 N 20181231 67544-154_c3fb8c8c-fa8d-4890-a843-1999add4d22b 67544-154 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 67544-161_74ba9277-cf16-4079-ad5b-b444357bf663 67544-161 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67544-185_28f2a162-654f-48d1-b0d8-41e06d8eca95 67544-185 HUMAN PRESCRIPTION DRUG Adalat CC nifedipine TABLET, FILM COATED ORAL 19930421 NDA NDA020198 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67544-189_d6e1473b-b1ff-4562-b1ab-65e820de2692 67544-189 HUMAN PRESCRIPTION DRUG Effexor XR Extended-Release venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19971101 NDA NDA020699 Aphena Pharma Solutions - Tennessee, Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67544-191_3437598f-3128-4bd3-a0e5-f55b485dee04 67544-191 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072926 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-194_bc534aeb-3ada-4dc5-8d65-d7b321f4b500 67544-194 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 67544-195_bc534aeb-3ada-4dc5-8d65-d7b321f4b500 67544-195 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 67544-204_a427cdfd-7e1f-4f7c-ba6a-167e56d9d340 67544-204 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 19981002 NDA NDA020998 Aphena Pharma Solutions - Tennessee, LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67544-206_0c1f0c4b-ed50-47ad-94a6-98a47ead9315 67544-206 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aphena Pharma Solutions - Tennessee, LLC AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67544-217_1a324c16-932a-45cd-9cb6-0fbe929ae3f1 67544-217 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 20121025 ANDA ANDA070920 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-224_4c645cf7-1073-45c1-a01f-537f067833f2 67544-224 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Aphena Pharma Solutions - Tennessee, LLC ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 67544-225_8eccf91e-8dd6-406a-bfe2-a45d49012d13 67544-225 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Aphena Pharma Solutions - Tennessee, LLC LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67544-236_74bda58d-0659-4d1d-b968-a2d3fbf6e50d 67544-236 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Aphena Pharma Solutions - Tennessee, LLC ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 67544-237_c3fb8c8c-fa8d-4890-a843-1999add4d22b 67544-237 HUMAN PRESCRIPTION DRUG Klor-Con Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 19860417 NDA NDA019123 Aphena Pharma Solutions - Tennessee, LLC POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 67544-240_b683fd4a-0b9c-4100-a6ff-73bc34b8e5d6 67544-240 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 19990617 ANDA ANDA073457 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67544-245_8eccf91e-8dd6-406a-bfe2-a45d49012d13 67544-245 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Aphena Pharma Solutions - Tennessee, LLC LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67544-247_de793f36-7be2-4f3e-89d9-0db5067cf561 67544-247 HUMAN PRESCRIPTION DRUG Lipitor ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 19961217 NDA NDA020702 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67544-250_2c24af9b-48af-4f5b-b4e5-50e0f2f87ed7 67544-250 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide lisinopril and hydrochlorothiazide TABLET ORAL 20130122 ANDA ANDA076113 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67544-251_a5cc3bc3-6e0e-4c01-b631-c927413f459b 67544-251 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19890503 ANDA ANDA071611 Aphena Pharma Solutions - Tennessee, LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67544-252_a6d39b9c-024a-4c09-b0c3-263456317fb4 67544-252 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 19990610 ANDA ANDA075191 Aphena Pharma Solutions - Tennessee, LLC PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 67544-253_0c1f0c4b-ed50-47ad-94a6-98a47ead9315 67544-253 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Aphena Pharma Solutions - Tennessee, LLC AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 67544-261_3437598f-3128-4bd3-a0e5-f55b485dee04 67544-261 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-268_e3c09b61-e055-476c-b814-9ef152507f28 67544-268 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE, GELATIN COATED ORAL 20070102 ANDA ANDA072252 Aphena Pharma Solutions - Tennessee, LLC OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-273_dd9b82e8-41a2-469e-b6fb-2332a1a38912 67544-273 HUMAN PRESCRIPTION DRUG Doxazosin doxazosin mesylate TABLET ORAL 20001020 ANDA ANDA075509 Aphena Pharma Solutions - Tennessee, LLC DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67544-276_8630b890-129e-4ef3-b8cb-afc47305a71e 67544-276 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 Aphena Pharma Solutions - Tennessee, LLC LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67544-282_c0c40b32-61c4-4f74-a388-b2459593531f 67544-282 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67544-287_349eedc7-991d-4012-9c58-0179f7350568 67544-287 HUMAN PRESCRIPTION DRUG Temazepam temazepam CAPSULE ORAL 19870803 ANDA ANDA071638 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-289_23891fcd-df44-428d-b328-335ca1b7c777 67544-289 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-290_02a9e5f5-eeaf-49fa-b28d-1b1f560ea902 67544-290 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Aphena Pharma Solutions - Tennessee, LLC ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-294_d3b80cc9-6730-42f7-8800-b6a52b432f9b 67544-294 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 19880419 20190831 ANDA ANDA071756 Aphena Pharma Solutions - Tennessee, LLC OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-298_bedd246d-d8fe-4d00-98bd-8042d81f964b 67544-298 HUMAN PRESCRIPTION DRUG Zoloft SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Aphena Pharma Solutions - Tennessee, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67544-299_39242415-ac47-4f36-8956-db01bd76f782 67544-299 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040322 ANDA ANDA075932 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 67544-301_23891fcd-df44-428d-b328-335ca1b7c777 67544-301 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-302_4458c829-ec73-4861-9ff6-3839cdc60643 67544-302 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Aphena Pharma Solutions - Tennessee, LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 67544-306_1e4cd5c0-6b72-4fae-a4c7-95f8ef34cc87 67544-306 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Aphena Pharma Solutions - Tennessee, Inc. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 67544-310_a09954f9-6bcf-4082-a363-406c4a4646e6 67544-310 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19810203 ANDA ANDA040424 Aphena Pharma Solutions - Tennessee, LLC SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 67544-318_7092a87a-54fb-4f82-8f58-0a950bf0db3d 67544-318 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 19990715 ANDA ANDA040301 Aphena Pharma Solutions - Tennessee, LLC WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 67544-322_1e4cd5c0-6b72-4fae-a4c7-95f8ef34cc87 67544-322 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Aphena Pharma Solutions - Tennessee, Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 67544-326_045a1d78-1ac0-4f65-958e-8777ab4b1cf2 67544-326 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67544-332_74ba9277-cf16-4079-ad5b-b444357bf663 67544-332 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073026 Aphena Pharma Solutions - Tennessee, LLC ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67544-338_5d3ad7cd-d844-49b9-adde-a05f12d0ea8a 67544-338 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67544-346_5d3ad7cd-d844-49b9-adde-a05f12d0ea8a 67544-346 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67544-349_feae1673-5b26-40a2-9127-24426383a86b 67544-349 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20110118 ANDA ANDA074726 Aphena Pharma Solutions - Tennessee, Inc. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 67544-353_03cba200-f94b-4357-bee2-b32b12f19891 67544-353 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67544-354_03cba200-f94b-4357-bee2-b32b12f19891 67544-354 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67544-355_adc5a44a-091a-4541-95af-9e3ec75f0eef 67544-355 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Aphena Pharma Solutions - Tennessee, LLC SILDENAFIL CITRATE 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 67544-356_adc5a44a-091a-4541-95af-9e3ec75f0eef 67544-356 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 19980327 NDA NDA020895 Aphena Pharma Solutions - Tennessee, LLC SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 67544-361_03cba200-f94b-4357-bee2-b32b12f19891 67544-361 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 Aphena Pharma Solutions - Tennessee, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67544-371_64ebbee6-7e2a-455f-9f96-92bc25d3e691 67544-371 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Aphena Pharma Solutions - Tennessee, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 67544-373_100df325-8fc5-4e54-95d9-19c8b1f81a13 67544-373 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19880112 ANDA ANDA071428 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-394_68d8e3a9-cabb-46aa-b327-9d024d41a6e7 67544-394 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 Aphena Pharma Solutions - Tennessee, LLC BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 67544-399_4e4b9eb1-c341-44b9-a496-590eb2c5c7e6 67544-399 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20020712 ANDA ANDA040256 Aphena Pharma Solutions - Tennessee, LLC PREDNISONE 5 mg/1 N 20181231 67544-401_bc534aeb-3ada-4dc5-8d65-d7b321f4b500 67544-401 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20090101 NDA NDA009218 Aphena Pharma Solutions - Tennessee, Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 67544-403_948ffea7-be2c-4b21-9880-8e27af9a4090 67544-403 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Aphena Pharma Solutions - Tennessee, LLC VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67544-404_948ffea7-be2c-4b21-9880-8e27af9a4090 67544-404 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Aphena Pharma Solutions - Tennessee, LLC VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67544-406_00ff6c58-e096-4d7a-8e7b-62d98946eac0 67544-406 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20000511 ANDA ANDA075491 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 67544-408_cb3df109-9a12-43f9-b1dd-99e156d81b11 67544-408 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20110209 NDA NDA019129 Aphena Pharma Solutions - Tennessee, LLC TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67544-410_38a0f82c-44c8-498c-93a5-85e618300359 67544-410 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20070401 UNAPPROVED DRUG OTHER Aphena Pharma Solutions - Tennessee, LLC SALSALATE 750 mg/1 N 20181231 67544-412_23891fcd-df44-428d-b328-335ca1b7c777 67544-412 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20090213 ANDA ANDA074869 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-431_da02b76d-00ea-4733-aef8-7808b0b45d47 67544-431 HUMAN PRESCRIPTION DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL 20050621 ANDA ANDA077222 Aphena Pharma Solutions - Tennessee, LLC FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 67544-456_81d7938c-6dd1-4368-a5fc-0b7b6c2b2ded 67544-456 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67544-464_e7ff7ec1-7773-4156-b2c4-f1b3d3ca8d07 67544-464 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20031125 ANDA ANDA075932 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 67544-468_c6cea106-a61e-4ee6-9961-c0e89109c372 67544-468 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH FINAL part343 Aphena Pharma Solutions - Tennessee, LLC ASPIRIN 325 mg/1 N 20181231 67544-474_6d0a1553-38cf-41c5-a7a4-1d738112d94c 67544-474 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089828 Aphena Pharma Solutions - Tennessee, LLC CODEINE PHOSPHATE; ACETAMINOPHEN 60; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 67544-475_81d7938c-6dd1-4368-a5fc-0b7b6c2b2ded 67544-475 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67544-479_4c40fbad-f018-45a5-813f-5a7dca18c9a6 67544-479 HUMAN PRESCRIPTION DRUG Valproic Acid valproic acid CAPSULE ORAL 19911029 ANDA ANDA073229 Aphena Pharma Solutions - Tennessee, LLC VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67544-491_267b96d9-2920-4d66-8adf-92b6aff7a5eb 67544-491 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 19920201 NDA NDA019962 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67544-507_2f463f71-cfb1-4db3-a004-02b88ceae1ad 67544-507 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20080515 NDA NDA021400 APHENA PHARMA SOLUTIONS - TENNESSEE, INC. VARDENAFIL HYDROCHLORIDE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 67544-510_6651d00a-865c-49c9-aa6f-b67b20893c1c 67544-510 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 Aphena Pharma Solutions - Tennessee, LLC OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 67544-511_4cb7dc91-6c9a-4feb-b2aa-7b4724e9f681 67544-511 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET ORAL 20050628 ANDA ANDA076716 Aphena Pharma Solutions - Tennessee, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67544-512_2f463f71-cfb1-4db3-a004-02b88ceae1ad 67544-512 HUMAN PRESCRIPTION DRUG Levitra vardenafil hydrochloride TABLET, FILM COATED ORAL 20080515 NDA NDA021400 APHENA PHARMA SOLUTIONS - TENNESSEE, INC. VARDENAFIL HYDROCHLORIDE 10 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 67544-517_b27917c2-0860-40e3-93c9-13327c25e7e0 67544-517 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 19990105 ANDA ANDA040298 Aphena Pharma Solutions - Tennessee, LLC PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 67544-524_4022ec92-1e3c-40a7-9a23-e28f40e79a12 67544-524 HUMAN OTC DRUG Aspirin EC Aspirin TABLET, COATED ORAL 19940205 OTC MONOGRAPH FINAL part343 Aphena Pharma Solutions - Tennessee, LLC ASPIRIN 81 mg/1 N 20181231 67544-534_4638c35e-72ef-4f22-832c-de21700093dc 67544-534 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19801126 NDA NDA017812 Aphena Pharma Solutions - Tennessee, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 67544-555_c0c40b32-61c4-4f74-a388-b2459593531f 67544-555 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20010326 NDA NDA019962 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67544-562_e880cdbb-908e-45e2-83c7-0742a66a1ef0 67544-562 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Aphena Pharma Solutions - Tennessee, LLC TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67544-563_e880cdbb-908e-45e2-83c7-0742a66a1ef0 67544-563 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Aphena Pharma Solutions - Tennessee, LLC TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67544-564_e880cdbb-908e-45e2-83c7-0742a66a1ef0 67544-564 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20041221 ANDA ANDA075317 Aphena Pharma Solutions - Tennessee, LLC TERAZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67544-567_f3bcf3f8-72ce-4359-877e-13cef7ecf1c1 67544-567 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130422 ANDA ANDA076704 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67544-568_7a2b5130-7c3c-4407-94dc-085e4e3652d1 67544-568 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19910313 ANDA ANDA070086 Aphena Pharma Solutions - Tennessee, LLC FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 67544-569_7c8f8413-4c41-4f54-9530-46f64782ced0 67544-569 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 19900930 ANDA ANDA071655 Aphena Pharma Solutions - Tennessee, LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 67544-570_37fa075f-798b-4335-8f5f-d76d513acdd8 67544-570 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20110119 ANDA ANDA075135 Aphena Pharma Solutions - Tennessee, LLC AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 67544-581_e880cdbb-908e-45e2-83c7-0742a66a1ef0 67544-581 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20041220 ANDA ANDA075317 Aphena Pharma Solutions - Tennessee, LLC TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67544-627_f3bcf3f8-72ce-4359-877e-13cef7ecf1c1 67544-627 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130422 ANDA ANDA076704 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67544-629_02a9e5f5-eeaf-49fa-b28d-1b1f560ea902 67544-629 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19951229 ANDA ANDA074112 Aphena Pharma Solutions - Tennessee, LLC ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-655_88c9255c-f367-4bfa-9179-15d0ac6d326a 67544-655 HUMAN OTC DRUG Bisacodyl Enteric Coated Bisacodyl TABLET, COATED ORAL 20081024 OTC MONOGRAPH NOT FINAL part334 Aphena Pharma Solutions - Tennessee, LLC BISACODYL 5 mg/1 N 20181231 67544-656_7bba784e-b2dd-4662-a66d-09246be23c7c 67544-656 HUMAN PRESCRIPTION DRUG Renagel Renagel TABLET ORAL 20080606 NDA NDA021179 Aphena Pharma Solutions - Tennessee, LLC SEVELAMER HYDROCHLORIDE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 67544-657_b08e0b2c-c3c7-42f4-a43c-5eb32ce5be79 67544-657 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 19900930 ANDA ANDA088467 Aphena Pharma Solutions - Tennessee, LLC HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 67544-662_12218dbe-1891-4491-b98c-caf6750ae792 67544-662 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Aphena Pharma Solutions - Tennessee, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67544-670_5d9e47c2-cf3a-4def-a906-1d7fe00c6620 67544-670 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100422 ANDA ANDA040400 Aphena Pharma Solutions - Tennessee, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII N 20181231 67544-671_ba0a7c8f-e018-4e0b-97df-8e5752eb03ad 67544-671 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20050830 ANDA ANDA077156 Aphena Pharma Solutions - Tennessee, LLC BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 67544-672_13d7ad8f-967c-44f3-a77a-e5adc3f50cc8 67544-672 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 19991006 ANDA ANDA075091 Aphena Pharma Solutions - Tennessee, LLC CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 67544-679_81d7938c-6dd1-4368-a5fc-0b7b6c2b2ded 67544-679 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Aphena Pharma Solutions - Tennessee, LLC NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67544-697_37c91b72-c47b-4200-a66a-2f3a24de2e43 67544-697 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20060628 ANDA ANDA077856 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-700_b13be519-3c63-40cb-a3ee-66ec6238310f 67544-700 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20121012 ANDA ANDA072741 Aphena Pharma Solutions - Tennessee, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 67544-720_d6b6a9b8-aa6a-4b5d-b5ce-564b858d67e9 67544-720 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20060331 ANDA ANDA077749 Aphena Pharma Solutions - Tennessee, LLC DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-725_7db1e55e-aa96-49a3-b21e-62e198e1877a 67544-725 HUMAN PRESCRIPTION DRUG Triazolam Triazolam TABLET ORAL 19940601 ANDA ANDA074224 Aphena Pharma Solutions - Tennessee, Inc. TRIAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-736_887b4ea6-3af9-4825-b453-176d44169b86 67544-736 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 19861024 ANDA ANDA018659 Aphena Pharma Solutions - Tennessee, LLC ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 67544-739_81155b23-9294-4758-80c8-5e33c4024868 67544-739 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 67544-747_12218dbe-1891-4491-b98c-caf6750ae792 67544-747 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20000101 ANDA ANDA085159 Aphena Pharma Solutions - Tennessee, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 67544-767_7fa2db15-e9e9-4e97-b544-208e64f73ba3 67544-767 HUMAN OTC DRUG Simethicone Simethicone TABLET, CHEWABLE ORAL 19990312 OTC MONOGRAPH FINAL part332 Aphena Pharma Solutions - Tennessee, LLC DIMETHICONE 80 mg/1 N 20181231 67544-807_b6848545-e2e1-40d1-aa7e-e5f6100b9edd 67544-807 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 19940126 ANDA ANDA074131 Aphena Pharma Solutions - Tennessee, LLC PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67544-840_f4f39613-d1df-48ec-9b69-2ec30b4a5dc4 67544-840 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Aphena Pharma Solutions - Tennessee, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67544-848_b6d3beec-9ded-46ae-9122-462504bf2741 67544-848 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20020129 ANDA ANDA075049 Aphena Pharma Solutions - Tennessee, LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67544-870_dc10ad3e-db44-4346-8945-fe25b0999f9f 67544-870 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20130305 ANDA ANDA077657 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-879_dc10ad3e-db44-4346-8945-fe25b0999f9f 67544-879 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20130305 ANDA ANDA077657 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-882_6d0a1553-38cf-41c5-a7a4-1d738112d94c 67544-882 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 19880930 ANDA ANDA089805 Aphena Pharma Solutions - Tennessee, LLC CODEINE PHOSPHATE; ACETAMINOPHEN 30; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 67544-883_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-883 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 67544-884_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-884 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 67544-885_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-885 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 67544-886_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-886 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 67544-887_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-887 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 67544-888_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-888 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 67544-889_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-889 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 67544-890_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-890 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020224 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 200 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 67544-891_81f2d4c7-c121-42a1-81a2-902b8eda11cf 67544-891 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Aphena Pharma Solutions - Tennessee, Inc. LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 67544-892_4656613f-ab12-4d5f-a7ad-573b6f0e2e3a 67544-892 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Aphena Pharma Solutions - Tennessee, LLC BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 67544-899_f4f39613-d1df-48ec-9b69-2ec30b4a5dc4 67544-899 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Aphena Pharma Solutions - Tennessee, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67544-911_f3bcf3f8-72ce-4359-877e-13cef7ecf1c1 67544-911 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20130422 ANDA ANDA076704 Aphena Pharma Solutions - Tennessee, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67544-946_4638c35e-72ef-4f22-832c-de21700093dc 67544-946 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE, GELATIN COATED ORAL 19870128 NDA NDA017812 Aphena Pharma Solutions - Tennessee, Inc. LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] E 20171231 67544-979_a2dfcc60-93ad-4523-aa81-fd2e2ed3a954 67544-979 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20051003 ANDA ANDA076418 Aphena Pharma Solutions - Tennessee, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67544-982_dc10ad3e-db44-4346-8945-fe25b0999f9f 67544-982 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20130305 ANDA ANDA077657 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67544-988_64ebbee6-7e2a-455f-9f96-92bc25d3e691 67544-988 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Aphena Pharma Solutions - Tennessee, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 67544-989_583ccb68-3d4b-4b3b-b0fa-c84dd33a0753 67544-989 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20160201 ANDA ANDA204418 Aphena Pharma Solutions - Tennessee, LLC FOLIC ACID 1 mg/1 N 20181231 67544-993_59f698be-ad3d-4c46-b99a-e381c7b4100d 67544-993 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20051003 ANDA ANDA076418 Aphena Pharma Solutions - Tennessee, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67544-996_50878745-f6d3-4a5c-ba86-83814855db5b 67544-996 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076578 Aphena Pharma Solutions - Tennessee, LLC ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 67546-111_5c87947c-42a3-f79e-e053-2a91aa0a8e01 67546-111 HUMAN PRESCRIPTION DRUG Alinia nitazoxanide TABLET ORAL 20040721 NDA NDA021497 Romark Laboratories, L.C. NITAZOXANIDE 500 mg/1 Antiprotozoal [EPC] N 20181231 67546-212_5c87947c-42a3-f79e-e053-2a91aa0a8e01 67546-212 HUMAN PRESCRIPTION DRUG Alinia nitazoxanide POWDER, FOR SUSPENSION ORAL 20021122 NDA NDA021498 Romark Laboratories, L.C. NITAZOXANIDE 100 mg/5mL Antiprotozoal [EPC] N 20181231 67555-140_a769b672-5a74-4d2a-a01a-e7c3c124d94e 67555-140 HUMAN PRESCRIPTION DRUG MaxFe ascorbic acid, folic acid, vitamin b-12, biotin, iron, magnesium, zinc TABLET ORAL 20140601 UNAPPROVED DRUG OTHER Pronova Corporation ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; IRON; MAGNESIUM; ZINC; DOCUSATE SODIUM 100; 1; 60; 150; 160; 6.5; 12; 50 mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 67555-153_b2ade83e-2dee-43e2-be8f-2e0a39057bba 67555-153 HUMAN PRESCRIPTION DRUG Folet DHA DHA (docosahexaenoic acid), Vit.A (beta-carotine), Vit.C (ascorbic acid), Vit.D-3 (cholecalciferol), Vit.E (d-alpha-tocopheryl acetate), Vit.B-1 (thiamine HCl), Vit.B-2 (riboflavin), Vit.B-3 (niacinamide), Vit.B-6 (pyridoxine HCl), Folate (1.85 mg (6S)-5-methyltetrahydrofolate-Quatrefolic), Vit.B-12 (cyanocobalamin), Iron (carbonyl iron -Ferronyl and ferrous bis-glycinate chelate -Ferrochel), Magnesium (magnesium oxide), Zinc (zinc bis-glycinate chelate -TRAACS), Selenium (sodium selenate), Docusate Sodium KIT 20140828 UNAPPROVED DRUG OTHER Pronova Corporation N 20181231 67555-154_fb5ae915-5d9b-49ef-b9bf-e6c3198681fb 67555-154 HUMAN PRESCRIPTION DRUG Folet One Vitamin C, Vitamin D, Vitamine E, Vitamine B6, Folate, Vitamine B12, Iron, Zinc, Magnesium, Docusate Sodium, DHA CAPSULE, LIQUID FILLED ORAL 20140601 UNAPPROVED DRUG OTHER Pronova Corporation ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; CHOLECALCIFEROL; IRON; MAGNESIUM; ZINC; DOCUSATE SODIUM; .ALPHA.-TOCOPHEROL, D-; PYRIDOXINE HYDROCHLORIDE; DOCONEXENT 18; 1; 15; 250; 38; 15; 20; 25; 15; 30; 225 mg/1; mg/1; ug/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 67567-0306_ccd725b8-1d98-4864-9429-b27d8498e7fe 67567-0306 HUMAN OTC DRUG HeadOn Ultimate Relief Iris Versicolor Root and Bryonia Alba Root STICK TOPICAL 20100601 UNAPPROVED HOMEOPATHIC American Health Distributions Inc. IRIS VERSICOLOR ROOT; BRYONIA ALBA ROOT 12; 12 [hp_X]/1; [hp_X]/1 E 20171231 67573-0101_bfadc1ca-4577-4a92-97b8-c4c71ac14002 67573-0101 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19770101 UNAPPROVED MEDICAL GAS B&J Welding Supply LTD OXYGEN 99.5 L/100L E 20171231 67573-0102_60b4424e-ae6f-3a26-e053-2991aa0abcbf 67573-0102 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19770101 NDA NDA205713 B & J Welding Supply, LTD. dba B & J Welding Supply NITROGEN 990 mL/L N 20181231 67573-0103_60de032e-6758-74c6-e053-2a91aa0a84cb 67573-0103 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19770101 NDA NDA205712 B & J WELDING SUPPLY, LTD. dba B & J Welding Supply OXYGEN 995 mL/L N 20181231 67573-0104_60ddb869-a6a7-2816-e053-2991aa0a9d56 67573-0104 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19770101 NDA NDA205712 B & J Welding Supply, LTD. dba B & J Welding Supply OXYGEN 995 mL/L N 20181231 67587-001_1d3b0ea6-b2b8-43df-b001-ece1677f6f89 67587-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19840101 UNAPPROVED MEDICAL GAS Allina Home Oxygen and Medical Equipment OXYGEN 99 L/100L E 20171231 67596-001_a58deb88-2037-43a9-aa7b-248c95cc3042 67596-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20011101 NDA NDA205827 Compressed Gas Solutions Inc OXYGEN 995 mL/L N 20181231 67596-002_ca4cc870-67f9-4ec7-a04a-2f3f9d8560aa 67596-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20021101 NDA NDA205866 Compressed Gas Solutions Inc NITROGEN 900 mL/L N 20181231 67618-100_cc5911b2-d9f7-6d43-acd2-31812a9ac392 67618-100 HUMAN OTC DRUG Colace Docusate sodium CAPSULE ORAL 19970130 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP DOCUSATE SODIUM 50 mg/1 N 20181231 67618-101_cc5911b2-d9f7-6d43-acd2-31812a9ac392 67618-101 HUMAN OTC DRUG Colace Docusate sodium CAPSULE ORAL 19970130 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP DOCUSATE SODIUM 100 mg/1 N 20181231 67618-106_f63ecf22-fb2b-8677-5bfe-c6ac368977a3 67618-106 HUMAN OTC DRUG Peri-Colace Docusate sodium - sennosides TABLET, FILM COATED ORAL 19570208 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 E 20171231 67618-109_50170f82-8611-4f12-b602-b227e8f7b380 67618-109 HUMAN OTC DRUG Colace Clear Docusate sodium CAPSULE, LIQUID FILLED ORAL 20141216 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP DOCUSATE SODIUM 50 mg/1 N 20181231 67618-110_9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b 67618-110 HUMAN OTC DRUG Colace Docusate sodium - sennosides TABLET, FILM COATED ORAL 19570208 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 67618-111_a1591da0-a1a9-9583-3cf5-788b8fee3814 67618-111 HUMAN OTC DRUG Colace Docusate sodium CAPSULE, LIQUID FILLED ORAL 19000107 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP DOCUSATE SODIUM 50 mg/1 N 20181231 67618-120_d5bf67e5-82c6-edbf-e9ec-e027fdd47c84 67618-120 HUMAN OTC DRUG Senokot standardized senna concentrate TABLET ORAL 19880901 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP SENNOSIDES 17.2 mg/1 N 20181231 67618-121_9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b 67618-121 HUMAN OTC DRUG Colace Docusate sodium - sennosides TABLET, FILM COATED ORAL 19570208 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 67618-148_2f07daa4-86ee-4a2d-ae3a-c3a7b574ed10 67618-148 HUMAN OTC DRUG Betadine POVIDONE-IODINE SPRAY TOPICAL 19920415 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE .05 mL/mL E 20171231 67618-149_95d5a340-2838-3630-1f87-eb005cadd532 67618-149 HUMAN OTC DRUG Betadine Skin Cleanser POVIDONE-IODINE SOLUTION TOPICAL 19800601 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE 7.5 mg/mL N 20181231 67618-150_701b239d-bc78-8e2f-fdaf-995e01e6487a 67618-150 HUMAN OTC DRUG Betadine Solution POVIDONE-IODINE SOLUTION TOPICAL 19800601 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE 10 mg/mL N 20181231 67618-151_d7f364bb-0985-9469-ed3e-25222edb1be6 67618-151 HUMAN OTC DRUG Betadine Surgical Scrub POVIDONE-IODINE SOLUTION TOPICAL 19960701 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE .075 mg/mL N 20181231 67618-152_d032d0f7-3cdc-29d9-7320-188113b08e30 67618-152 HUMAN OTC DRUG Betadine POVIDONE-IODINE SWAB TOPICAL 19920401 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE 100 mg/mL E 20171231 67618-153_0707b259-52a4-4ae6-b176-d093865906e7 67618-153 HUMAN OTC DRUG Betadine Solution Swabsticks POVIDONE-IODINE SWAB TOPICAL 19720915 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE .01 mL/1 N 20181231 67618-160_fddb8d6e-f4e3-445b-a694-53fcc4493703 67618-160 HUMAN OTC DRUG Betadine POVIDONE-IODINE SPRAY TOPICAL 19920415 OTC MONOGRAPH NOT FINAL part333A Purdue Products LP POVIDONE-IODINE .5 mg/mL N 20181231 67618-200_159978b1-eb8a-96f2-3ca7-192d2d4b49a7 67618-200 HUMAN OTC DRUG BETASEPT Antiseptic Surgical Scrub SOLUTION TOPICAL 19930601 NDA NDA019125 Purdue Products LP CHLORHEXIDINE GLUCONATE .04 mg/mL N 20181231 67618-300_dda298c4-9fad-a129-377a-8d8a4c8303de 67618-300 HUMAN OTC DRUG Senokot standardized senna concentrate TABLET ORAL 19560601 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP SENNOSIDES 8.6 mg/1 N 20181231 67618-310_a4612a52-5b94-eda3-1be2-9de402e7413d 67618-310 HUMAN OTC DRUG Senokot-S standardized senna concentrate and docusate sodium TABLET ORAL 19741001 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 67618-315_08e1a2f2-be14-95ba-f1ae-f7744e8af835 67618-315 HUMAN OTC DRUG SenokotXTRA standardized senna concentrate TABLET ORAL 19880901 OTC MONOGRAPH NOT FINAL part334 Purdue Products LP SENNOSIDES 17.2 mg/1 N 20181231 67623-001_c23e887b-fe13-4d68-8c6a-d7c5ebff1ffb 67623-001 HUMAN OTC DRUG Exel Clarifying Line SPF 50 Octinoxate, Octocrylene, Oxybenzone, Tatanium Dioxide CREAM TOPICAL 20150514 OTC MONOGRAPH FINAL part352 Biocosmetica Exel Argentina SRL OCTINOXATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 8; 3; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 67659-041_3c62d647-d17e-4da8-a141-48dc6bff4242 67659-041 HUMAN OTC DRUG Laura Lynn Anticavity Sodium Fluoride PASTE DENTAL 20060829 OTC MONOGRAPH FINAL part355 Team Technologies, Inc SODIUM FLUORIDE 2.43 mg/g E 20171231 67659-062_57b1a2f3-8c90-4b32-8533-894237cf293d 67659-062 HUMAN OTC DRUG Walgreens Anticavity and Antigingivits Whitening Fluoride Toothpaste Anticavity and Antigingivitis Whitening Fluoride PASTE, DENTIFRICE DENTAL 20081124 UNAPPROVED OTHER Team Technologies, Inc SODIUM FLUORIDE 2.43 mg/g E 20171231 67659-078_f4b1f6e9-1f51-4204-a2d0-bbcf28baa62c 67659-078 HUMAN OTC DRUG Up and Up Sensitive Toothpaste Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20100825 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g E 20171231 67659-079_18708150-8558-400f-84b2-62ea4a8ddc0e 67659-079 HUMAN OTC DRUG Up and Up Sensitive Toothpaste Whitening Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20100825 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; 2.43 mg/g; mg/g E 20171231 67659-080_a82a82ab-ee33-4a07-8a3b-354c1394fd96 67659-080 HUMAN OTC DRUG Up and UP Sensitive Toothpaste Enamel Strengthening formula Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20100825 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; 1.5 mg/g; mg/g E 20171231 67659-081_0b63aecc-599e-4662-a77e-e2a0a47bb051 67659-081 HUMAN OTC DRUG Up and UP Sensitive Toothpaste Enamel Strengthening formula plus whitening Potassium Nitrate and Sodium Fluoride PASTE DENTAL 20100825 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc POTASSIUM NITRATE; SODIUM FLUORIDE 5; 1.5 mg/g; mg/g E 20171231 67659-082_a4b74051-aca6-4926-a464-41bf4539d968 67659-082 HUMAN OTC DRUG Up and Up Anticavity Toothpaste Whitening Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100825 OTC MONOGRAPH FINAL part355 Team Technologies, Inc SODIUM FLUORIDE 2.43 mg/g E 20171231 67659-083_b0b132a3-c7b9-4996-b326-36b7fe1c0167 67659-083 HUMAN OTC DRUG Up and Up Anticavity Toothpaste Multi Function Stannous Fluoride PASTE, DENTIFRICE DENTAL 20100825 OTC MONOGRAPH FINAL part355 Team Technologies, Inc STANNOUS FLUORIDE 4.54 mg/g E 20171231 67659-084_586b4bf2-5c80-40b8-bcad-44d678a6d40c 67659-084 HUMAN OTC DRUG Up and UP Anticavity Toothpaste Whitening Plus Mouthwash Sodium Fluoride PASTE, DENTIFRICE DENTAL 20100825 OTC MONOGRAPH FINAL part355 Team Technologies, Inc SODIUM FLUORIDE 2.43 mg/g E 20171231 67659-085_33e7c7b7-299b-42c2-86e4-fcc30dbeb8b1 67659-085 HUMAN OTC DRUG Walgreens Scooby Doo Fluoride Gel Toothpaste Sodium Fluoride PASTE DENTAL 20100802 OTC MONOGRAPH FINAL part355 Team Technologies, Inc SODIUM FLUORIDE 2.4 mg/g N 20181231 67659-150_3c13e246-9176-7314-e054-00144ff8d46c 67659-150 HUMAN OTC DRUG Orajel for Cold Sores Single Dose Benzalkonium Chloride, Benzocaine LIQUID TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc BENZALKONIUM CHLORIDE; BENZOCAINE .13; .5 mg/g; mg/g E 20171231 67659-300_33215bb8-ce5e-4774-e054-00144ff8d46c 67659-300 HUMAN OTC DRUG Total Whitening Sodium Fluoride and Triclosan PASTE DENTAL 20100810 NDA NDA020231 Team Technologies, Inc SODIUM FLUORIDE; TRICLOSAN 1.4; 3 mg/g; mg/g E 20171231 67659-310_3347049b-424f-490b-e054-00144ff8d46c 67659-310 HUMAN OTC DRUG Colgate Total Whitening Gel Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20100920 NDA NDA020231 Team Technologies, Inc SODIUM FLUORIDE; TRICLOSAN 1.4; 3 mg/g; mg/g E 20171231 67659-320_334818df-e60b-5a5e-e054-00144ff88e88 67659-320 HUMAN OTC DRUG Colgate Total Fresh Mint Stripe Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20130805 NDA NDA020231 Team Technologies, Inc SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g E 20171231 67659-330_33484705-de4c-5ead-e054-00144ff88e88 67659-330 HUMAN OTC DRUG Colgate Optic White Sparkling Mint Flavor SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20131218 OTC MONOGRAPH FINAL part355 Team Technologies, Inc SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 67659-340_3349e22c-d3db-66d5-e054-00144ff8d46c 67659-340 HUMAN OTC DRUG Colgate Optic White Platinum Express White Fresh Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141031 OTC MONOGRAPH FINAL part355 Team Technologies, Inc SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 67659-341_3879d864-c90e-1af0-e054-00144ff88e88 67659-341 HUMAN OTC DRUG Colgate Optic White High Impact Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20150901 OTC MONOGRAPH FINAL part355 Team Technologies, Inc SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 67659-350_334a3704-d090-0a85-e054-00144ff8d46c 67659-350 HUMAN OTC DRUG Colgate Total Advance Whitening Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20080809 NDA NDA020231 Team Technologies, Inc SODIUM FLUORIDE; TRICLOSAN 1.5; 3 mg/g; mg/g E 20171231 67659-360_334a8671-a4cc-35d4-e054-00144ff88e88 67659-360 HUMAN OTC DRUG Colgate Total Advanced Whitening Sodium Fluoride and Triclosan PASTE, DENTIFRICE DENTAL 20100921 NDA NDA020231 Team Technologies, Inc SODIUM FLUORIDE; TRICLOSAN 2.4; 3 mg/g; mg/g E 20171231 67659-370_42fda6e5-c78b-1e07-e054-00144ff8d46c 67659-370 HUMAN OTC DRUG Colgate MaxFresh with Mini Breath Cool Mint SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20130923 OTC MONOGRAPH FINAL part355 Team Technologies, Inc SODIUM FLUORIDE 1.4 mg/g E 20171231 67659-400_3afd5a15-02f0-27d3-e054-00144ff88e88 67659-400 HUMAN OTC DRUG DenTek Eugenol Eugenol LIQUID DENTAL 20150701 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc EUGENOL 850 mg/mL E 20171231 67659-405_3afd5a15-02d4-27d3-e054-00144ff88e88 67659-405 HUMAN OTC DRUG Walgreens Natural Eugenol/Toothache Medication with cotton pellets and tweezers Eugenol LIQUID DENTAL 20150701 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc EUGENOL 850 mg/mL E 20171231 67659-410_3afdfbd6-fcc4-4a7a-e054-00144ff8d46c 67659-410 HUMAN OTC DRUG DenTek Instant Pain Relief Maximum Strength Benzocaine LIQUID DENTAL; TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc BENZOCAINE 200 mg/mL E 20171231 67659-415_3afd5a15-02ef-27d3-e054-00144ff88e88 67659-415 HUMAN OTC DRUG Eugenol Toothache Medication Eugenol LIQUID DENTAL 20150701 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc EUGENOL 850 mg/mL E 20171231 67659-500_330d04d2-1934-163c-e054-00144ff88e88 67659-500 HUMAN OTC DRUG Colgate Total Advanced Pro-Shield Peppermint Blast CETYLPYRIDINIUM CHLORIDE RINSE DENTAL 20130506 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc CETYLPYRIDINIUM CHLORIDE 15 mg/20mL E 20171231 67659-501_330dda24-9b4a-2dca-e054-00144ff8d46c 67659-501 HUMAN OTC DRUG Colgate Total Advanced Pro-Shield Spearmint Surge CETYLPYRIDINIUM CHLORIDE RINSE DENTAL 20130506 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc CETYLPYRIDINIUM CHLORIDE 15 mg/20mL E 20171231 67659-502_330dda24-9b4c-2dca-e054-00144ff8d46c 67659-502 HUMAN OTC DRUG Colgate Total Advanced Gum Health Mouthwash CETYLPYRIDINIUM CHLORIDE RINSE DENTAL 20150301 OTC MONOGRAPH NOT FINAL part356 Team Technologies, Inc CETYLPYRIDINIUM CHLORIDE .75 mg/mL E 20171231 67659-900_328078d1-f935-20de-e054-00144ff88e88 67659-900 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20100805 ANDA ANDA077789 Team Technologies, Inc CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] E 20171231 67659-901_3ad6fa05-81e8-4055-e054-00144ff8d46c 67659-901 HUMAN OTC DRUG Dyna-Hex 2 CHLORHEXIDINE GLUCONATE LIQUID TOPICAL 20140101 NDA NDA019422 Team Technologies, Inc CHLORHEXIDINE GLUCONATE 2 g/100mL E 20171231 67662-001_286fff75-296a-4268-be96-5b63a797ee41 67662-001 HUMAN OTC DRUG Mediflex Menthol CREAM TOPICAL 20100329 OTC MONOGRAPH NOT FINAL part348 SAS Group Inc. MENTHOL 5 1/85g E 20171231 67668-161_89050554-8e16-41ce-88a5-30718b7f6f9c 67668-161 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Unique Pharmaceutical Laboratories CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 67668-162_ba27b932-bae3-41d2-bfe4-017c4f036670 67668-162 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Unique Pharmaceutical Laboratories CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 67676-002_c70fcff3-e7dd-419f-8a43-38f72a705d7e 67676-002 HUMAN OTC DRUG Joint Formula 88 MAX PLUS CAMPHOR CREAM TOPICAL 20130801 OTC MONOGRAPH NOT FINAL part348 Sarati International, Inc. CAMPHOR (SYNTHETIC) 3.18 g/100g N 20181231 67676-101_bbf16863-b493-4b27-8a56-0c3eeb4e4af9 67676-101 HUMAN OTC DRUG OsmoFlex MENTHOL CREAM TOPICAL 19930101 OTC MONOGRAPH NOT FINAL part348 Sarati International, Inc. MENTHOL 1.3 g/100g N 20181231 67684-1901_451d8280-a75d-48c0-ae5e-a286d99d49f7 67684-1901 HUMAN PRESCRIPTION DRUG LIPIODOL ethiodized oil INJECTION INTRA-ARTERIAL; INTRALYMPHATIC; INTRAUTERINE 20140321 NDA NDA009190 Guerbet LLC ETHIODIZED OIL 480 mg/mL N 20181231 67684-2000_c205ab10-1eda-46aa-8b40-6a1b8d83ec56 67684-2000 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20130320 NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] N 20181231 67684-2000_cbb97d0c-13d7-4fbc-b65a-e2e39fcac7d6 67684-2000 HUMAN PRESCRIPTION DRUG DOTAREM gadoterate meglumine INJECTION INTRAVENOUS 20130426 NDA NDA204781 Guerbet LLC GADOTERATE MEGLUMINE 376.9 mg/mL Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] N 20181231 67691-100_ed1fd10a-08b6-453c-9f91-6be4e4104829 67691-100 HUMAN OTC DRUG Plum Emergency Eyewash Water LIQUID OPHTHALMIC 20080208 OTC MONOGRAPH FINAL part349 Bel-Art Products WATER 99.1 mL/100mL E 20171231 67691-101_f3f0c462-9820-4493-8a5c-6852b2c8ec80 67691-101 HUMAN OTC DRUG Plum Duo Emergency Eyewash Water LIQUID OPHTHALMIC 20100623 OTC MONOGRAPH FINAL part349 Bel-Art Products WATER 99.1 mL/100mL E 20171231 67691-200_2e1ad903-c25b-45d3-ad11-31a26666d1c5 67691-200 HUMAN OTC DRUG Plum Emergency Eyewash pH Neutralizing Water LIQUID OPHTHALMIC 20080601 OTC MONOGRAPH FINAL part349 Bel-Art Products WATER 95.1 mL/100mL E 20171231 67691-201_78acd337-53d8-40d9-bdaf-dc7fdf23f2f0 67691-201 HUMAN OTC DRUG Plum Duo Emergency Eyewash pH Neutralizing Water LIQUID OPHTHALMIC 20100623 OTC MONOGRAPH FINAL part349 Bel-Art Products WATER 95.1 mL/100mL E 20171231 67691-769_decaf0f9-ef6f-4c90-aaaf-775c2b2ee504 67691-769 HUMAN OTC DRUG Scienceware Eyewash Water SOLUTION OPHTHALMIC 19940101 20181231 OTC MONOGRAPH FINAL part349 Bel-Art Products WATER 98.5 mL/100mL N 20181231 67691-770_c1f73e85-7170-4554-abd9-cedb0bd53620 67691-770 HUMAN OTC DRUG Scienceware Eyewash Water SOLUTION OPHTHALMIC 20170115 OTC MONOGRAPH FINAL part349 Bel-Art WATER 98.3 mL/100mL N 20181231 67692-141_21fbe595-ab9c-6aaa-e054-00144ff8d46c 67692-141 HUMAN OTC DRUG Lumene Bright Now Vitamin C Day SPF 15 Sunscreen Broad Spectrum OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part352 LUMENE OY OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE 75; 50; 40; 30 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 67692-148_2174de78-5ac0-4021-e054-00144ff88e88 67692-148 HUMAN OTC DRUG Lumene Bright Now Vitamin C BB SPF 20 Sunscreen Broad Spectrum 01 Light OCTINOXATE CREAM TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part352 LUMENE OY OCTINOXATE 60 mg/mL E 20171231 67692-149_2174de78-5ab0-4021-e054-00144ff88e88 67692-149 HUMAN OTC DRUG Lumene Bright Now Vitamin C BB SPF 20 Sunscreen Broad Spectrum 02 Medium OCTINOXATE CREAM TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part352 LUMENE OY OCTINOXATE 60 mg/mL E 20171231 67692-242_616723f7-a5ef-d1fe-e053-2991aa0ab47e 67692-242 HUMAN OTC DRUG Lumene Valo Day Moisturizer SPF 15 Sunscreen Broad Spectrum SPF 15 OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20160910 OTC MONOGRAPH NOT FINAL part352 Lumene Oy OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE 75; 50; 40; 30 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67692-290_f8c559b4-f78b-47d9-bdc9-86825d436b1c 67692-290 HUMAN OTC DRUG Lumene Bright Now Visible Repair Day SPF 15 Sunscreen Broad Spectrum AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20140514 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 60; 20; 27.5 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 67692-332_e24a000e-e2fa-4f76-ab9a-34cd42e8ebb2 67692-332 HUMAN OTC DRUG Lumene Time Freeze Firming Day SPF 15 Sunscreen Broad Spectrum AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130904 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 60; 20; 27 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 67692-339_720e594c-95a5-4d89-8cd0-70534fe577ff 67692-339 HUMAN OTC DRUG Lumene Time Freeze Targeted Dark Spot Corrector Sunscreen SPF 30 OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20130821 OTC MONOGRAPH NOT FINAL part352 LUMENE OY OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 75; 60; 70 mg/mL; mg/mL; mg/mL E 20171231 67692-340_08c42984-cc37-498c-807b-80b15c18af2e 67692-340 HUMAN OTC DRUG LUMENE TIME FREEZE FIRMING DAY SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20131107 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 60; 20; 27 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 67692-434_61673a9c-c038-efe7-e053-2a91aa0ac1ad 67692-434 HUMAN OTC DRUG Lumene Sisu Moisture Remedy Day Sunscreen Broad Spectrum SPF 20 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20170704 OTC MONOGRAPH NOT FINAL part352 Lumene Oy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 80; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67692-470_3e29e49e-4993-4909-8a1e-fc696c575f8a 67692-470 HUMAN OTC DRUG Lumene Complete Rewind Recovery Day SPF 15 Sunscreen Broad Spectrum AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20130411 OTC MONOGRAPH NOT FINAL part352 LUMENE OY AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 60; 20; 27 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 67692-810_9f3df133-6972-4e67-853f-6c75c396a902 67692-810 HUMAN OTC DRUG Lumene Time Freeze Anti-Age CC Color Correcting SPF 20 Sunscreen Broad Spectrum LIGHT OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20130409 OTC MONOGRAPH NOT FINAL part352 LUMENE OY OCTINOXATE; TITANIUM DIOXIDE 40; 8.3 mg/mL; mg/mL N 20181231 67692-811_7e7d7996-7d03-43ff-9262-8705732621a8 67692-811 HUMAN OTC DRUG Lumene Time Freeze Anti-Age CC Color Correcting SPF 20 Sunscreen Broad Spectrum MEDIUM OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20130409 OTC MONOGRAPH NOT FINAL part352 LUMENE OY OCTINOXATE; TITANIUM DIOXIDE 40; 8.3 mg/mL; mg/mL N 20181231 67692-821_616723f7-a619-d1fe-e053-2991aa0ab47e 67692-821 HUMAN OTC DRUG LUMENE CC COLOR CORRECTING SUNSCREEN BROAD SPECTRUM SPF 20 LIGHT OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20170329 OTC MONOGRAPH NOT FINAL part352 Lumene Oy OCTINOXATE; TITANIUM DIOXIDE 40; 8 mg/mL; mg/mL N 20181231 67692-823_616723f7-a60b-d1fe-e053-2991aa0ab47e 67692-823 HUMAN OTC DRUG LUMENE CC COLOR CORRECTING SUNSCREEN BROAD SPECTRUM SPF 20 MEDIUM OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20170329 OTC MONOGRAPH NOT FINAL part352 Lumene Oy OCTINOXATE; TITANIUM DIOXIDE 40; 8 mg/mL; mg/mL N 20181231 67692-881_616723f7-a5fe-d1fe-e053-2991aa0ab47e 67692-881 HUMAN OTC DRUG Lumene Bright Now Vitamin C Moisturizer OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20151006 OTC MONOGRAPH NOT FINAL part352 Lumene Oy OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE 75; 50; 40; 30 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67703-001_6195e63c-01ec-6c90-e053-2991aa0ae81a 67703-001 HUMAN OTC DRUG Rhulief Pain Relieving Balm MENTHOL, CAMPHOR (SYNTHETIC) CREAM TOPICAL 20170126 OTC MONOGRAPH NOT FINAL part348 EuroPharma, Inc MENTHOL; CAMPHOR (SYNTHETIC) 1.3; 3.5 g/100g; g/100g N 20191231 67703-002_531b5ea5-efba-1250-e054-00144ff88e88 67703-002 HUMAN OTC DRUG Rhulief Pain Relieving Balm MENTHOL, CAMPHOR (SYNTHETIC) CREAM TOPICAL 20170126 OTC MONOGRAPH NOT FINAL part348 EuroPharma, Inc MENTHOL; CAMPHOR (SYNTHETIC) 1.3; 3.5 g/100g; g/100g N 20181231 67711-001_326b38a9-8e52-489d-a074-f940ac108cb1 67711-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20030101 UNAPPROVED MEDICAL GAS AIRSERVE, LLC OXYGEN 991 mL/L N 20181231 67718-893_af74aa01-7237-4b4b-a512-b9420f63fe9c 67718-893 HUMAN OTC DRUG Garnier Fructis Antidandruff Mint Cleanse Pyrithione Zinc SHAMPOO TOPICAL 20110301 OTC MONOGRAPH FINAL part358H L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 3.84 mL/384mL E 20171231 67718-938_8eb943db-d446-4184-a34c-d7deb18d7875 67718-938 HUMAN OTC DRUG Garnier Fructis Antidandruff Clean and Fresh Pyrithione Zinc SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358 L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 3.84 mL/384mL E 20171231 67718-939_81e5565c-bdd2-42f6-8019-21ffe5ef2eec 67718-939 HUMAN OTC DRUG Garnier Fructis Antidandruff Clean and Fresh 2 in 1 Pyrithione Zinc SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358 L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 3.84 mL/384mL E 20171231 67718-941_bfc8e562-ca15-4e10-8668-83125f6f65e4 67718-941 HUMAN OTC DRUG Garnier Fructis Antidandruff Clean and Fresh 2 in 1 Pyrithione Zinc SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358 L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 7.5 mL/750mL E 20171231 67718-942_83185022-b482-423e-9f42-cbcd15b45d09 67718-942 HUMAN OTC DRUG Garnier Fructis Antidandruff Dry Scalp Pyrithione Zinc SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358 L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 3.84 mL/384mL E 20171231 67718-943_2c2ef2f5-1f11-4ce7-b3aa-e4563b376baf 67718-943 HUMAN OTC DRUG Garnier Fructis Antidandruff Dry Scalp Pyrithione Zinc SHAMPOO TOPICAL 20100701 OTC MONOGRAPH FINAL part358 L'Oreal USA Florence Manufacturing PYRITHIONE ZINC 7.5 mL/750mL E 20171231 67718-963_6b6b32f6-ec59-45f0-98b1-e1be3d648317 67718-963 HUMAN OTC DRUG Garnier Fructis Antidandruff Clear Control Salicylic Acid SHAMPOO TOPICAL 20110301 OTC MONOGRAPH FINAL part358H L'Oreal USA Florence Manufacturing SALICYLIC ACID 11.52 mL/384mL E 20171231 67750-1234_ead891eb-55c6-4153-b5f5-e9b02075de62 67750-1234 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030228 UNAPPROVED MEDICAL GAS J & L Medical Services LLC OXYGEN 99 L/100L E 20171231 67751-001_46221ccf-9257-4c40-aa39-1c9487f90540 67751-001 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20130424 OTC MONOGRAPH NOT FINAL part333A Navajo Mfg. Co. HYDROGEN PEROXIDE 3 mL/100mL N 20181231 67751-002_eb55b81b-e9e5-4b3f-b2a6-3994e913a103 67751-002 HUMAN OTC DRUG Handy Solutions Rubbing Alcohol ISOPROPYL ALCOHOL LIQUID TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part333A Navajo Manufacturing Company Inc. ISOPROPYL ALCOHOL 700 mg/mL N 20181231 67751-009_8909f5e5-2267-44a0-a30c-e5b3882e8f89 67751-009 HUMAN OTC DRUG Handy Solutions GENUINE ASPIRIN BAYER Aspirin TABLET ORAL 20130821 OTC MONOGRAPH FINAL part343 Navajo Manufacturing Company Inc. ASPIRIN 325 mg/1 E 20171231 67751-011_49794b5a-d9d2-4fa1-9690-7cd9c2594602 67751-011 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part333E Navajo Manufacturing Company Inc. ALCOHOL 36.58 mL/59mL N 20181231 67751-011_7d49ec0b-bd39-4efa-a1cc-5701b7c7f992 67751-011 HUMAN OTC DRUG HAND SANITIZER Alcohol LIQUID TOPICAL 20110711 OTC MONOGRAPH NOT FINAL part333E Navajo Manufacturing Company Inc. ALCOHOL 36.58 mL/59mL N 20181231 67751-011_cdc1cd37-db67-4d32-83a2-2cf255502f96 67751-011 HUMAN OTC DRUG HAND SANITIZER alcohol LIQUID TOPICAL 20110630 OTC MONOGRAPH NOT FINAL part333E Navajo Manufacturing Company Inc. ALCOHOL 6.2 mL/10mL N 20181231 67751-033_2f31d6a6-c01d-4912-e054-00144ff8d46c 67751-033 HUMAN OTC DRUG Allegra Allergy FEXOFENADINE HYDROCHLORIDE TABLET ORAL 20150512 NDA NDA020872 Navajo Manufacturing Co., Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 E 20171231 67751-035_98bc728d-2f0e-449f-9459-21b0aa00d95f 67751-035 HUMAN OTC DRUG Handy Solutions Mint Fluoride Tooth SODIUM FLUORIDE PASTE DENTAL 20150621 OTC MONOGRAPH FINAL part355 Navajo Manufacturing Co., Inc. SODIUM FLUORIDE 2.5 mg/g E 20171231 67751-036_2912c87d-5e0a-7363-e054-00144ff88e88 67751-036 HUMAN OTC DRUG Handy Solutions First Aid Kit Antiseptic Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20160109 OTC MONOGRAPH NOT FINAL part333A Navajo Manufacturing Company Inc. BENZALKONIUM CHLORIDE .1 g/100g E 20171231 67751-052_65a0acbf-abb8-4444-a74c-4b96c8d87c69 67751-052 HUMAN OTC DRUG Handy Solutions Crest Cavity Protection FLUORIDE ANTICAVITY SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 20130624 OTC MONOGRAPH FINAL part355 Navajo Manufacturing Company Inc SODIUM FLUORIDE .15 g/100g N 20181231 67751-053_49087629-8798-47c1-afc4-77a3425ae32b 67751-053 HUMAN OTC DRUG Head and Shoulders Classic Clean Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20130531 OTC MONOGRAPH FINAL part358H Navajo Manufacturing Company Inc PYRITHIONE ZINC 10 mg/mL N 20181231 67751-058_97a90348-bca0-4386-b263-339e2f38420d 67751-058 HUMAN OTC DRUG Degree Shower Clean Anti-perspirant and Deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20130603 OTC MONOGRAPH FINAL part350 Navajo Manufacturing Company Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 182 mg/g N 20181231 67751-085_614028d5-c45a-2e33-e053-2991aa0adf21 67751-085 HUMAN OTC DRUG Handy Solutions Instant Hand Sanitizer With Aloe And Vitamin E ALCOHOL LIQUID TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part333E Navajo Manufacturing Company Inc. ALCOHOL 62 mL/100mL N 20181231 67751-094_656b96fa-8545-4671-9e7a-36c3f8298ddd 67751-094 HUMAN OTC DRUG Handy Solutions Kidz Crest Sparkle Fun Sodium Fluoride PASTE, DENTIFRICE DENTAL 20130821 OTC MONOGRAPH FINAL part355 Navajo Manufacturing Company Inc. SODIUM FLUORIDE .243 mg/100g N 20181231 67751-095_f4ff486f-f651-44d8-bb4b-a79b74a62d26 67751-095 HUMAN OTC DRUG Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 20130816 OTC MONOGRAPH FINAL part355 Navajo Manufacturing Company Inc SODIUM FLUORIDE .15 g/100g N 20181231 67751-102_76d9b2e7-4f8e-4134-a9ab-7e23d8e2b5f4 67751-102 HUMAN OTC DRUG Handy Solutions LISTERINE ANTISEPTIC MOUTHWASH Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20130821 OTC MONOGRAPH NOT FINAL part356 Navajo Manufacturing Company Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67751-103_d8e0c456-22ea-43e3-8977-f17a38d02329 67751-103 HUMAN OTC DRUG Handy Solutions Cool Mint LISTERINE ANTISEPTIC MOUTHWASH Eucalyptol, Menthol, Methyl Salicylate, and Thymol MOUTHWASH ORAL 20130821 OTC MONOGRAPH NOT FINAL part356 Navajo Manufacturing Company Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67751-130_60f11cbe-c0a5-ad92-e053-2991aa0ac75a 67751-130 HUMAN OTC DRUG Refresh Tears Lubricant CARBOXYMETHYLCELLULOSE SODIUM SOLUTION/ DROPS OPHTHALMIC 20040901 OTC MONOGRAPH FINAL part349 Navajo Manufacturing Company Inc. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 67751-131_60dbe6f0-4622-6f13-e053-2991aa0a742a 67751-131 HUMAN OTC DRUG Colgate Total Clean Mint ANTIGINGIVITIS SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 20130624 NDA NDA020231 Navajo Manufacturing Company Inc SODIUM FLUORIDE; TRICLOSAN .14; .3 g/100g; g/100g N 20181231 67751-132_a82ca29d-9531-4efe-8ef0-95c0aec2ae2f 67751-132 HUMAN OTC DRUG Handy Solutions Colgate Cavity Protection SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20130816 OTC MONOGRAPH FINAL part355 Navajo Manufacturing Company Inc SODIUM MONOFLUOROPHOSPHATE .15 g/100g N 20181231 67751-134_bed740fc-b821-40ea-9f11-d42e516f2716 67751-134 HUMAN OTC DRUG Handy Solutions Dove Cool Essential Cucumber and Green Tea Scent Anti-Perspirant Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130816 OTC MONOGRAPH FINAL part350 Navajo Manufacturing Company Inc. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.2 g/100g N 20181231 67751-135_871c28b1-11ec-4e00-9dde-1a92cd74d933 67751-135 HUMAN OTC DRUG Lady Speed INVISIBLE DRY antiperspirant deodorant ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK TOPICAL 20130624 OTC MONOGRAPH FINAL part350 Navajo Manufacturing Company Inc ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15.4 g/100g E 20171231 67751-140_2af930ea-9dbf-443e-ac6e-e50db60fb08a 67751-140 HUMAN OTC DRUG Handy Solutions Antiseptic Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20120418 OTC MONOGRAPH NOT FINAL part333A Navajo Manuracturing Company BENZALKONIUM CHLORIDE .13 g/100g N 20181231 67751-141_3cf2681a-764a-4457-e054-00144ff88e88 67751-141 HUMAN OTC DRUG Excedrin Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET ORAL 20160916 OTC MONOGRAPH NOT FINAL part343 Navajo Manufacturing Company Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 67751-142_3cf2c5bd-3aec-1bf5-e054-00144ff8d46c 67751-142 HUMAN OTC DRUG Alka Seltzer Plus Cold ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE TABLET ORAL 20160917 OTC MONOGRAPH NOT FINAL part343 Navajo Manufacturing Company Inc. ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 N 20181231 67751-143_3cf2c5bd-3b02-1bf5-e054-00144ff8d46c 67751-143 HUMAN OTC DRUG Alka Seltzer Original ANHYDROUS CITRIC ACID, ASPIRIN, SODIUM BICARBONATE TABLET ORAL 20160916 OTC MONOGRAPH NOT FINAL part343 Navajo Manufacturing Company Inc. ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 325; 1916 mg/1; mg/1; mg/1 N 20181231 67751-144_3cf2681a-765c-4457-e054-00144ff88e88 67751-144 HUMAN OTC DRUG Aleve NAPROXEN SODIUM TABLET ORAL 20160917 NDA NDA020204 Navajo Manufacturing Company Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 67751-144_60637aeb-deb7-4747-e053-2a91aa0ad00b 67751-144 HUMAN OTC DRUG Aleve naproxen sodium TABLET ORAL 20171204 NDA NDA020204 Navajo Manufacturing Company Inc NAPROXEN SODIUM 220 mg/1 N 20181231 67751-145_60ceba37-b323-e3d3-e053-2991aa0adfd2 67751-145 HUMAN OTC DRUG Midol ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE TABLET ORAL 20160919 OTC MONOGRAPH NOT FINAL part343 Navajo Manufacturing Company Inc. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 67751-146_3d0924fb-2e9b-6928-e054-00144ff8d46c 67751-146 HUMAN OTC DRUG Advil IBUPROFEN TABLET ORAL 20160920 NDA NDA018989 Navajo Manufacturing Company Inc. IBUPROFEN 200 mg/1 N 20181231 67751-147_3cf2c9b1-d1ea-2ab3-e054-00144ff8d46c 67751-147 HUMAN OTC DRUG Advil PM DIPHENHYDRAMINE CITRATE, IBUPROFEN TABLET ORAL 20160916 OTC MONOGRAPH NOT FINAL part343 Navajo Manufacturing Company Inc. DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 67751-148_3d090f5e-bf60-6460-e054-00144ff8d46c 67751-148 HUMAN OTC DRUG Advil Liquigels IBUPROFEN CAPSULE ORAL 20160920 NDA NDA020402 Navajo Manufacturing Company Inc. IBUPROFEN 200 mg/1 N 20181231 67751-149_3cf2c9b1-d1fd-2ab3-e054-00144ff8d46c 67751-149 HUMAN OTC DRUG Advil Allergy and Congestion Relief CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20160916 OTC MONOGRAPH NOT FINAL part343 Navajo Manufacturing Company Inc. CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 4; 200; 10 mg/1; mg/1; mg/1 N 20181231 67751-150_3d09a83a-31de-0cfa-e054-00144ff88e88 67751-150 HUMAN OTC DRUG Advil Sinus Congestion and Pain Relief IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20160920 NDA NDA022565 Navajo Manufacturing Company Inc. IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200; 10 mg/1; mg/1 N 20181231 67751-151_3cf2bc41-69db-3cc7-e054-00144ff88e88 67751-151 HUMAN OTC DRUG Zantac 150 RANITIDINE TABLET ORAL 20160916 NDA NDA021698 Navajo Manufacturing Company Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 67751-152_3cf2c9b1-d210-2ab3-e054-00144ff8d46c 67751-152 HUMAN OTC DRUG Zantac 75 RANITIDINE TABLET ORAL 20160917 NDA NDA020520 Navajo Manufacturing Company Inc. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 67751-153_3cf2c9b1-d221-2ab3-e054-00144ff8d46c 67751-153 HUMAN OTC DRUG Claritin LORATADINE TABLET ORAL 20160917 NDA NDA019658 Navajo Manufacturing Company Inc. LORATADINE 10 mg/1 N 20181231 67751-153_60a5dc14-3f75-8414-e053-2991aa0ad34a 67751-153 HUMAN OTC DRUG Claritin loratadine TABLET ORAL 20171204 NDA NDA019658 Navajo Manufacturing Company LORATADINE 10 mg/1 N 20181231 67751-154_3d0924fb-2eaf-6928-e054-00144ff8d46c 67751-154 HUMAN OTC DRUG Flanax Pain and Fever Reliever NAPROXEN SODIUM TABLET ORAL 20160920 ANDA ANDA079096 Navajo Manufacturing Company Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 67751-155_3fdde0de-9f9b-0c5a-e054-00144ff8d46c 67751-155 HUMAN OTC DRUG Pepto Bismol BISMUTH SUBSALICYLATE TABLET, CHEWABLE ORAL 20160920 OTC MONOGRAPH FINAL part335 Navajo Manufacturing Company Inc. BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 67751-156_3dab851e-72a5-3bc9-e054-00144ff8d46c 67751-156 HUMAN OTC DRUG ZZZQuil Nightime Sleep-Aid DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, GELATIN COATED ORAL 20160929 OTC MONOGRAPH FINAL part338 Navajo Manufacturing Company Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 67751-157_3da9e463-1b32-54c0-e054-00144ff88e88 67751-157 HUMAN OTC DRUG Vicks Vapo Rub Camphor, Mentol, Eucalyptus Oil OINTMENT TOPICAL 20160919 OTC MONOGRAPH FINAL part341 Navajo Manufacturing Company Inc. CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL .048; .012; .026 g/g; g/g; g/g N 20181231 67751-158_60c7392f-4247-357a-e053-2991aa0ac02a 67751-158 HUMAN OTC DRUG DayQuil Severe ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20160921 OTC MONOGRAPH FINAL part341 Navajo Manufacturing Company Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 67751-159_3d1b7fcf-76e2-073b-e054-00144ff88e88 67751-159 HUMAN OTC DRUG NyQuil Severe ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20160921 OTC MONOGRAPH FINAL part341 Navajo Manufacturing Company Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 67751-160_3d1b7fcf-76f5-073b-e054-00144ff88e88 67751-160 HUMAN OTC DRUG Vivarin CAFFEINE TABLET ORAL 20160921 OTC MONOGRAPH FINAL part340 Navajo Manufacturing Company Inc. CAFFEINE 200 mg/1 N 20181231 67751-161_3d1b7fcf-7706-073b-e054-00144ff88e88 67751-161 HUMAN OTC DRUG Handy Solutions Acetaminophen ACETAMINOPHEN TABLET ORAL 20160921 OTC MONOGRAPH NOT FINAL part343 Navajo Manufacturing Company Inc. ACETAMINOPHEN 500 mg/1 N 20181231 67751-162_3d1b65d0-c311-06a7-e054-00144ff88e88 67751-162 HUMAN OTC DRUG Handy Solutions Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE TABLET ORAL 20160921 ANDA ANDA074091 Navajo Manufacturing Company Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 67751-163_3d1b65d0-c324-06a7-e054-00144ff88e88 67751-163 HUMAN OTC DRUG Handy Solutions 24 Hour Allergy LORATADINE TABLET ORAL 20160922 ANDA ANDA076134 Navajo Manufacturing Company Inc. LORATADINE 10 mg/1 N 20181231 67751-164_3d1f464c-e96b-0836-e054-00144ff8d46c 67751-164 HUMAN OTC DRUG Handy Solutions Ibuprofen IBUPROFEN TABLET ORAL 20160922 ANDA ANDA075010 Navajo Manufacturing Company Inc. IBUPROFEN 200 mg/1 N 20181231 67751-165_3d1fc6cd-8234-206e-e054-00144ff88e88 67751-165 HUMAN OTC DRUG Motrin IB IBUPROFEN TABLET ORAL 20160922 NDA NDA019012 Navajo Manufacturing Company Inc. IBUPROFEN 200 mg/1 N 20181231 67751-166_3d1f3084-4c6b-02b6-e054-00144ff8d46c 67751-166 HUMAN OTC DRUG Benadryl Ultratabs DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20160922 OTC MONOGRAPH FINAL part341 Navajo Manufacturing Company Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 67751-167_3d1f3084-4c7d-02b6-e054-00144ff8d46c 67751-167 HUMAN OTC DRUG Tylenol Extra Strength ACETAMINOPHEN TABLET ORAL 20160922 OTC MONOGRAPH NOT FINAL part343 Navajo Manufacturing Company Inc. ACETAMINOPHEN 500 mg/1 N 20181231 67751-168_3d1f84be-fde9-1789-e054-00144ff88e88 67751-168 HUMAN OTC DRUG Tylenol PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20160922 OTC MONOGRAPH NOT FINAL part343 Navajo Manufacturing Company Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 67751-169_3d1f3084-4c8f-02b6-e054-00144ff8d46c 67751-169 HUMAN OTC DRUG Sominex DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20160922 OTC MONOGRAPH FINAL part338 Navajo Manufacturing Company Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 67751-170_3d2f94b3-6902-4308-e054-00144ff8d46c 67751-170 HUMAN OTC DRUG Dramamine DIMENHYDRINATE TABLET ORAL 20160923 OTC MONOGRAPH FINAL part336 Navajo Manufacturing Company Inc. DIMENHYDRINATE 50 mg/1 N 20181231 67751-171_3d6a2710-0d54-6d9b-e054-00144ff88e88 67751-171 HUMAN OTC DRUG Mucinex DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN TABLET ORAL 20160923 NDA NDA021620 Navajo Manufacturing Company Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30; 600 mg/1; mg/1 N 20181231 67751-172_3d30ebab-f59b-1418-e054-00144ff8d46c 67751-172 HUMAN OTC DRUG Bayer Aspirin ASPIRIN TABLET ORAL 20160923 OTC MONOGRAPH FINAL part343 Navajo Manufacturing Company Inc. ASPIRIN 325 mg/1 N 20181231 67751-173_3d30db81-64fd-681f-e054-00144ff88e88 67751-173 HUMAN OTC DRUG Allegra Allergy FEXOFENADINE HYDROCHLORIDE TABLET ORAL 20160923 NDA NDA020872 Navajo Manufacturing Company Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 67751-174_3d30cbfc-a9f6-137b-e054-00144ff8d46c 67751-174 HUMAN OTC DRUG Sal De Uvas Picot CITRIC ACID MONOHYDRATE, SODIUM BICARBONATE POWDER, FOR SOLUTION ORAL 20160923 OTC MONOGRAPH FINAL part331 Navajo Manufacturing Company Inc. CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 1.9485; 2.485 g/1; g/1 N 20181231 67751-175_3fa2fa6c-1941-48d5-e054-00144ff88e88 67751-175 HUMAN OTC DRUG Handy Solutions Headache Pain Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET TOPICAL 20161021 OTC MONOGRAPH NOT FINAL part343 Navajo Manufacturing Company Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 67751-176_3fa3451f-a5ef-236f-e054-00144ff8d46c 67751-176 HUMAN OTC DRUG Handy Solutions Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20161022 OTC MONOGRAPH FINAL part341 Navajo Manufacturing Company Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 67751-177_3fa33b85-9938-5199-e054-00144ff88e88 67751-177 HUMAN OTC DRUG Handy Solutions Cold Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20161022 OTC MONOGRAPH FINAL part341 Navajo Manufacturing Company Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 15; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 67751-178_3fa33b85-9949-5199-e054-00144ff88e88 67751-178 HUMAN OTC DRUG Handy Solutions Sinus Congestion and Pain Relief ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20161022 OTC MONOGRAPH FINAL part341 Navajo Manufacturing Company Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 67751-179_60b42298-c557-534b-e053-2a91aa0a881b 67751-179 HUMAN OTC DRUG Banana Boat avobenzone, homosalate, octocrylene LOTION TOPICAL 20171204 OTC MONOGRAPH NOT FINAL part352 Navajo Manufacturing Company Inc. OCTOCRYLENE; HOMOSALATE; AVOBENZONE 5; 7; 1.8 g/100g; g/100g; g/100g N 20181231 67751-180_60ce2412-fe95-2e04-e053-2991aa0a2a3d 67751-180 HUMAN OTC DRUG ChapIce Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20171220 OTC MONOGRAPH NOT FINAL part352 Navajo Manufacturing Company Inc. OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g N 20181231 67751-181_60f5d008-d29a-1386-e053-2a91aa0af62b 67751-181 HUMAN OTC DRUG Fruit of the Earth Block Up Kids SPF 50 Moisturizing Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20171222 OTC MONOGRAPH NOT FINAL part352 Navajo Manufacturing Company Inc. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 20; 90; 75; 50; 50; 15 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67751-182_614064f5-9adf-0c70-e053-2a91aa0a9b3c 67751-182 HUMAN OTC DRUG Fruit of the Earth Block Up Sport SPF 30 Sunscreen Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20171226 OTC MONOGRAPH NOT FINAL part352 Navajo Manufacturing Company Inc. OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; OXYBENZONE 75; 15; 50; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67751-183_61834dc7-f7c8-1a53-e053-2991aa0a4d98 67751-183 HUMAN OTC DRUG Aveeno Active Naturals Daily Moisturizing Dimethicone CREAM TOPICAL 20171204 OTC MONOGRAPH FINAL part347 Navajo Manufacturing Company INc. DIMETHICONE 12 mg/g N 20181231 67752-0001_928c5bfc-70bc-4ff6-a6db-7b404538ec79 67752-0001 HUMAN OTC DRUG AMSure Alcohol Prep ISOPROPYL ALCOHOL SWAB TOPICAL 20120301 OTC MONOGRAPH NOT FINAL part333A Amsino International, Inc. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 67752-2003_9bd269b7-ebe5-4c99-8dd6-3023cdd3f3f0 67752-2003 HUMAN OTC DRUG AMSure Three Povidone-Iodine Swabsticks Povidone-Iodine SWAB TOPICAL 20120106 OTC MONOGRAPH FINAL part333C Amsino International, Inc. POVIDONE-IODINE .1 mg/mL N 20181231 67760-001_a8720875-eb13-4a8e-a48f-6ac72cd27b99 67760-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130712 UNAPPROVED MEDICAL GAS Respiratory At Home Plus OXYGEN 99 L/100L N 20181231 67772-016_b6bb06b5-a3d6-466a-a8a3-744e6d071cac 67772-016 HUMAN OTC DRUG Freeman Packing Hand Sanitizer 004 ISOPROPYL ALCOHOL LIQUID TOPICAL 20150412 UNAPPROVED DRUG OTHER Jiangxi Sencen Hygienic Products Co., Ltd. ISOPROPYL ALCOHOL 13 g/100g N 20181231 67772-018_37725329-7247-4f8b-bf0b-b9e3971de6b1 67772-018 HUMAN OTC DRUG Freeman Packing Alcohol Wipe Alcohol LIQUID TOPICAL 20150412 UNAPPROVED DRUG OTHER Jiangxi Sencen Hygienic Products Co., Ltd. ALCOHOL; CHLORHEXIDINE GLUCONATE 40; 1 g/100g; g/100g N 20181231 67773-001_74a33f6c-5ef3-411f-b352-daf82eb3ea1c 67773-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20100712 UNAPPROVED MEDICAL GAS Oxygen Plus OXYGEN 99 L/100L N 20181231 67777-001_3e1d46cb-a7a3-4bdb-9f5b-b612134d2c24 67777-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Oxygen Plus OXYGEN 99 L/100L N 20181231 67777-100_3cbe99e8-56c9-47eb-a086-3e954b3fe398 67777-100 HUMAN OTC DRUG povidone iodine povidine iodine SOLUTION TOPICAL 20020103 OTC MONOGRAPH FINAL part333C Dynarex Corporation POVIDONE-IODINE 10 mg/mL N 20181231 67777-110_6757fee4-939c-4430-8cda-77b5a8c5fad2 67777-110 HUMAN OTC DRUG povidine iodine povidine iodine SOLUTION TOPICAL 20020103 OTC MONOGRAPH FINAL part333C Dynarex Corporation POVIDONE-IODINE 7.5 mg/mL N 20181231 67777-120_3254578d-a959-4e2b-880d-56b12be39c14 67777-120 HUMAN OTC DRUG Alcohol Swabstick Alcohol Swabstick SWAB TOPICAL 20100301 OTC MONOGRAPH FINAL part344 Dynarex Corporation ISOPROPYL ALCOHOL 1.4 mL/1 N 20181231 67777-121_5a9377a6-b148-8859-e053-2a91aa0abdea 67777-121 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20191231 67777-129_58985046-ca9d-12be-e053-2991aa0abe72 67777-129 HUMAN OTC DRUG XeroBurn Burn Gel Lidocaine Hydrochloride GEL TOPICAL 20170907 OTC MONOGRAPH NOT FINAL part348 Dynarex Corporation LIDOCAINE HYDROCHLORIDE 2 g/100g N 20181231 67777-130_6e0bb046-ea9e-471b-82aa-815a291dbaef 67777-130 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20100510 OTC MONOGRAPH FINAL part333C Dynarex Corporation POVIDONE-IODINE 10 mg/mL N 20181231 67777-140_56609c63-de60-4111-a317-4f0fc1db502b 67777-140 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20100510 OTC MONOGRAPH FINAL part333 Dynarex Corporation POVIDONE-IODINE 10 mL/100mL N 20181231 67777-160_4385d760-1b33-4570-82d6-7fec76a38b34 67777-160 HUMAN OTC DRUG Lemon Glycerin Glycerin SWAB ORAL 20110621 OTC MONOGRAPH NOT FINAL part356 Dynarex Corporation GLYCERIN 7.5 mL/100mL N 20181231 67777-171_d7333da1-d49a-4966-b31b-35aa1f81665e 67777-171 HUMAN OTC DRUG Morning Fresh Sodium Monofluorophosphate PASTE ORAL 20100608 OTC MONOGRAPH FINAL part355 Dynarex Corporation SODIUM MONOFLUOROPHOSPHATE 1 mg/g E 20171231 67777-172_59c0872c-839a-4289-8af0-7f53c9784010 67777-172 HUMAN OTC DRUG Morning Fresh Sodium Monofluorophosphate PASTE ORAL 20130405 OTC MONOGRAPH FINAL part355 Dynarex Corporation SODIUM MONOFLUOROPHOSPHATE 1 mg/g N 20181231 67777-173_640c16fc-0e0f-4b38-a4f7-eedb6b90059e 67777-173 HUMAN OTC DRUG Morning Fresh Sodium Monofluorophosphate PASTE ORAL 20130405 OTC MONOGRAPH FINAL part355 Dynarex Corporation SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 67777-174_ef3e3c40-6cd3-4f6f-a2c7-51ea1c64cf83 67777-174 HUMAN OTC DRUG Morning Fresh Sodium Fluoride PASTE ORAL 20140514 OTC MONOGRAPH FINAL part355 Dynarex Corporation SODIUM FLUORIDE 2.2 mg/g E 20171231 67777-175_22333ed6-8e3d-4dd0-a8c0-57dcf7060bd8 67777-175 HUMAN OTC DRUG Morning Fresh Sodium Fluoride PASTE ORAL 20141014 OTC MONOGRAPH FINAL part355 Dynarex Corporation SODIUM MONOFLUOROPHOSPHATE 76 mg/g N 20181231 67777-211_98f2d4bc-3a59-45d5-91c1-11833a06dc89 67777-211 HUMAN OTC DRUG PETROLATUM PETROLATUM JELLY TOPICAL 20100131 OTC MONOGRAPH FINAL part347 Dynarex Corporation PETROLATUM 1 g/g N 20181231 67777-214_31b53cb3-c24a-4584-88f6-25a3fdd37a9b 67777-214 HUMAN OTC DRUG Vitamin A D PETROLATUM OINTMENT TOPICAL 20100324 OTC MONOGRAPH FINAL part347 Dynarex Corporation PETROLATUM .76 g/g N 20181231 67777-215_4b346a37-9ad3-4854-8a45-79a8764f5016 67777-215 HUMAN OTC DRUG Vitamin A D PETROLATUM OINTMENT TOPICAL 20131001 OTC MONOGRAPH FINAL part347 Dynarex Corporation PETROLATUM .93 g/g N 20181231 67777-217_a8c780de-f159-4899-81f1-5296613fc87c 67777-217 HUMAN OTC DRUG bacitracin zinc, neomycin sulfate and polymyxin b sulfate bacitracin zinc, neomycin sulfate and polymyxin b sulfate OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Dynarex Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g N 20191231 67777-219_eb0099e9-bf25-48df-b434-17eb039c31da 67777-219 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Dynarex Corporation BACITRACIN 500 [iU]/g N 20181231 67777-220_bdb18a0e-bb64-4392-a431-51995629186b 67777-220 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Dynarex Corporation BACITRACIN ZINC 500 [USP'U]/g N 20181231 67777-222_40fc2186-bc31-4f75-a444-0adb3d784bbb 67777-222 HUMAN OTC DRUG Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20100316 OTC MONOGRAPH FINAL part347 Dynarex Corporation ZINC OXIDE 200 mg/g N 20181231 67777-224_fc1451ee-0a34-47d8-85b5-f01aa8293b79 67777-224 HUMAN OTC DRUG Hydrocortisone Hydrocortisone Acetate CREAM TOPICAL 20100202 OTC MONOGRAPH NOT FINAL part348 Dynarex Corporation HYDROCORTISONE ACETATE 1 g/100g N 20181231 67777-226_a137e963-1fa0-4772-a6a1-1d7a01bf1040 67777-226 HUMAN OTC DRUG zinc oxide zinc oxide OINTMENT TOPICAL 20110201 OTC MONOGRAPH FINAL part347 Dynarex Corporation ZINC OXIDE 1.8 g/100g N 20181231 67777-228_00f98114-0277-4d4f-ba9d-59e1af5e8fa9 67777-228 HUMAN OTC DRUG Dynashield with Dimethicone zinc oxide and dimethicone CREAM TOPICAL 20090901 OTC MONOGRAPH FINAL part347 Dynarex Corporation ZINC OXIDE; DIMETHICONE 200; 18 mg/g; mg/g N 20181231 67777-231_64299d04-03cf-1537-e053-2a91aa0a4f75 67777-231 HUMAN OTC DRUG Dynarex Antifungal antifungal CREAM TOPICAL 20100518 OTC MONOGRAPH FINAL part333C Dynarex Corporation CLOTRIMAZOLE 1 g/100g N 20191231 67777-232_a2902a28-599d-4c10-8a0c-957b4bed94f2 67777-232 HUMAN OTC DRUG Lanolin Lanolin OINTMENT TOPICAL 20100512 OTC MONOGRAPH FINAL part347 Dynarex Corporation LANOLIN 50 g/100g N 20181231 67777-233_6575bb22-da84-4249-a064-8e0db3d8e419 67777-233 HUMAN OTC DRUG Dynarex Hydrogel glycerin GEL TOPICAL 20100526 OTC MONOGRAPH FINAL part346 Dynarex Corporation GLYCERIN 20 g/100g N 20181231 67777-234_5c83272b-4e2b-4400-b709-681fdc60b895 67777-234 HUMAN OTC DRUG Menthol and Zinc Oxide Menthol and Zinc Oxide OINTMENT TOPICAL 20100511 OTC MONOGRAPH FINAL part347 Dynarex Corporation MENTHOL; ZINC OXIDE .44; 21 g/100g; g/100g N 20181231 67777-235_30ff050f-234c-41e0-8552-c780c02b7574 67777-235 HUMAN OTC DRUG Benzocaine Benzocaine SWAB TOPICAL 20110124 OTC MONOGRAPH FINAL part348 Dynarex Corporation BENZOCAINE .12 mL/1 E 20171231 67777-237_489256ed-4c2a-4ab5-9728-612498b677fa 67777-237 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20100202 OTC MONOGRAPH FINAL part348 Dynarex Corporation HYDROCORTISONE 1 g/100g E 20171231 67777-238_3865719d-c769-45ea-b91a-126f78dfd72a 67777-238 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Dynarex Corporation BACITRACIN ZINC 500 [iU]/g E 20171231 67777-239_656a9b59-1f64-41e4-9f8d-6870a1eda963 67777-239 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Dynarex Corporation BACITRACIN ZINC 500 [iU]/g E 20171231 67777-240_17776a1c-d279-4cdc-8860-ce18c2ceca34 67777-240 HUMAN OTC DRUG bacitracin zinc, neomycin sulfate and polymyxin b sulfate bacitracin zinc, neomycin sulfate and polymyxin b sulfate OINTMENT TOPICAL 20110316 OTC MONOGRAPH FINAL part333B Dynarex Corporation BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 67777-243_74655b86-7e50-47e8-ab37-19e7920f45b3 67777-243 HUMAN OTC DRUG BZK Pads Benzalkonium Chloride SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 67777-244_dc72eb70-9500-409c-b763-ece157e6dee0 67777-244 HUMAN OTC DRUG BZK Pads Benzalkonium Chloride SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 67777-245_f5e358b9-4891-4252-93c8-95573949245c 67777-245 HUMAN OTC DRUG BZK Pads Benzalkonium Chloride SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 67777-246_5b1f1c25-a2c3-613b-e053-2991aa0a1ede 67777-246 HUMAN OTC DRUG Benzocaine Benzocaine SWAB TOPICAL 20110720 OTC MONOGRAPH FINAL part348 Dynarex Corporation BENZOCAINE 60 mg/mL N 20181231 67777-251_fd97cde7-7b3b-40c0-8dbd-86dc1005fced 67777-251 HUMAN OTC DRUG Ammonia Inhalants Ammonia Inhalants INHALANT RESPIRATORY (INHALATION) 19760214 UNAPPROVED DRUG OTHER Dynarex Corporation AMMONIA .05 g/.33mL N 20181231 67777-300_53857704-e6fd-4174-bf40-71251d644bc6 67777-300 HUMAN OTC DRUG Alcohol Alcohol SWAB TOPICAL 20120607 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 67777-301_99a0044c-71d6-4377-9834-8c573d088bf0 67777-301 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20120210 OTC MONOGRAPH FINAL part333C Dynarex Corporation POVIDONE-IODINE 10 mL/100mL N 20181231 67777-302_0ee60a38-7e15-41ea-9828-15f8c5503df4 67777-302 HUMAN OTC DRUG Dual Swab Scrub Swabstick Povidone Iodine SWAB TOPICAL 20151115 OTC MONOGRAPH FINAL part333C Dynarex Corporation POVIDONE-IODINE 7.5 g/100g N 20181231 67777-303_e790de87-37b9-4859-bb5a-265767a309ea 67777-303 HUMAN OTC DRUG Dual Swab Scrub Swabstick Povidone Iodine SWAB TOPICAL 20151115 OTC MONOGRAPH FINAL part333C Dynarex Corporation POVIDONE-IODINE 10 g/100g N 20181231 67777-304_39d6dde5-524e-46fe-b3e0-3afcc2bfb116 67777-304 HUMAN OTC DRUG Alcohol Isopropyl Alcohol LIQUID TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 67777-305_8a2edc76-a746-436e-bb18-2dd174fd8466 67777-305 HUMAN OTC DRUG Alcohol Isopropyl Alcohol LIQUID TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ISOPROPYL ALCOHOL .99 mL/mL N 20181231 67777-306_cbff770c-92d2-481a-8ba5-6f08854c24ae 67777-306 HUMAN OTC DRUG Dynarex HP 3 Hydrogen peroxide LIQUID TOPICAL 20140129 OTC MONOGRAPH NOT FINAL part356 Dynarex Corporation HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 67777-307_c3984737-3b99-4011-b17b-dc3d3ffec4be 67777-307 HUMAN OTC DRUG Dynarex Green ALCOHOL LIQUID TOPICAL 20140128 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ALCOHOL .3 mL/mL N 20181231 67777-308_f470020d-a25d-4ed5-ae66-d5f6e3b0bd2f 67777-308 HUMAN OTC DRUG Dynarex Green ALCOHOL LIQUID TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ALCOHOL .3 mL/mL N 20181231 67777-316_a79294fd-685d-4904-84a1-b747485e326d 67777-316 HUMAN OTC DRUG Dynarex Antifungal Powder Miconazole POWDER TOPICAL 20160519 OTC MONOGRAPH FINAL part333C Dynarex Corporation MICONAZOLE NITRATE 20 mg/g N 20181231 67777-317_af40cc69-e850-4fda-a745-cc61f84064a6 67777-317 HUMAN OTC DRUG SannyTize Hand Sanitizer Alcohol GEL TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ALCOHOL .62 mL/mL N 20181231 67777-318_8661ed0d-5ce6-49ef-bae0-60b29a354214 67777-318 HUMAN OTC DRUG Dynarex Green Chloroxylenol LIQUID TOPICAL 20170313 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation CHLOROXYLENOL .15 g/100mL N 20181231 67777-320_0a90eb19-4351-4784-9af7-8083811bf358 67777-320 HUMAN OTC DRUG SannyTize Hand Sanitizer Wipe Alcohol GEL TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation ALCOHOL .7 mL/mL N 20181231 67777-400_b582c7fd-fb35-42a1-a897-3bb219d19851 67777-400 HUMAN OTC DRUG PETROLATUM PETROLATUM JELLY TOPICAL 20100323 OTC MONOGRAPH FINAL part347 Dynarex Corporation PETROLATUM 1 g/g E 20171231 67777-401_70550386-0a48-4cd4-84c9-fc9b6e1bfc61 67777-401 HUMAN OTC DRUG Enema Mineral Oil ENEMA RECTAL 20120829 OTC MONOGRAPH NOT FINAL part334 Dynarex Corporation MINERAL OIL 1 mL/mL N 20181231 67777-402_1b7d3bcf-b2b6-43ff-9422-5bea71d87f3b 67777-402 HUMAN OTC DRUG Saline Enema Sodium Phosphate Monobasic, Sodium Phosphate Dibasic ENEMA RECTAL 20120829 OTC MONOGRAPH NOT FINAL part334 Dynarex Corporation SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC 7; 19 g/118mL; g/118mL N 20181231 67777-403_d82b9634-780b-4fae-b0d7-0a4f5c6a7a9d 67777-403 HUMAN OTC DRUG Wound Cleanser Wound cleanser SPRAY TOPICAL 20170213 OTC MONOGRAPH NOT FINAL part333A Dynarex Corporation BENZETHONIUM CHLORIDE 1.3 mg/mL N 20181231 67777-404_4b1b8aeb-f368-46a2-8bfd-516e2a1436b9 67777-404 HUMAN OTC DRUG DYNAREX LAXATIVE MINERAL OIL LIQUID ORAL 20140305 OTC MONOGRAPH NOT FINAL part334 Dynarex Corporation MINERAL OIL 99 g/100g E 20171231 67777-405_8258c2d4-e0f9-45fe-8ce0-bf9acf607524 67777-405 HUMAN OTC DRUG Medicaine Sting and Bite Benzocaine SWAB TOPICAL 19760214 UNAPPROVED DRUG OTHER Dynarex Corporation BENZOCAINE .12 g/.6mL N 20181231 67777-406_5f3125c7-6a19-4f04-abec-268887d57814 67777-406 HUMAN OTC DRUG Muscle rub Menthol, Camphor, Methyl Salicylate CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part348 Dynarex Corporation MENTHOL; CAMPHOR (NATURAL); METHYL SALICYLATE 100; 40; 300 mg/g; mg/g; mg/g N 20181231 67777-407_92fa4cde-86a1-4fec-b4dc-71be29ff8d6b 67777-407 HUMAN OTC DRUG Dynashield zinc oxide OINTMENT TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Dynarex Corporation ZINC OXIDE 1.8 g/100g N 20181231 67777-408_20f612df-d984-44f3-8ccf-2c073be8a4b9 67777-408 HUMAN OTC DRUG Dynashield with Dimethicone zinc oxide OINTMENT TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Dynarex Corporation ZINC OXIDE; DIMETHICONE 2; 1.8 g/100g; g/100g N 20181231 67777-409_eb1c3ee3-da0c-4fc9-b9ca-dae83ae09492 67777-409 HUMAN OTC DRUG Menthol and Zinc Oxide Menthol and Zinc Oxide OINTMENT TOPICAL 20141011 OTC MONOGRAPH FINAL part347 Dynarex Corporation MENTHOL; ZINC OXIDE .44; 21 g/100g; g/100g N 20181231 67777-410_75d4bffb-cc22-40c2-a8cd-442239d4067c 67777-410 HUMAN OTC DRUG Lanashield Lanolin OINTMENT TOPICAL 20141012 OTC MONOGRAPH FINAL part347 Dynarex Corporation LANOLIN 50 g/100g N 20181231 67777-411_cb6df2a7-008b-49cd-9d23-4ffd1df20ed7 67777-411 HUMAN OTC DRUG Vitamin AD Petrolatum OINTMENT TOPICAL 20150510 OTC MONOGRAPH FINAL part347 Dynarex Corporation PETROLATUM .93 g/g N 20181231 67777-412_f24d37cd-5b6d-4b78-8821-92d3ea4afd35 67777-412 HUMAN OTC DRUG Dynarex Burn Cream Lidocaine CREAM TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part348 Dynarex Corporation LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE .5; .13 g/100g; g/100g N 20181231 67777-414_5648176b-331a-4aa9-b76f-0c006e94fb52 67777-414 HUMAN OTC DRUG Dual Swab Povidone-Iodine Prep Povidone Iodine KIT 20151115 OTC MONOGRAPH FINAL part333C Dynarex Corporation N 20181231 67777-415_e9cb7007-906b-48bb-8548-e75d5773715c 67777-415 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20151202 OTC MONOGRAPH NOT FINAL part348 Dynarex Corporation HYDROCORTISONE 1 g/100g N 20181231 67777-416_e54b6cd6-dd30-4eb6-8324-303507b128a9 67777-416 HUMAN OTC DRUG Dynarex Muscle Rub Cream Menthol and Methyl Salicylate CREAM TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part348 Dynarex Corporation MENTHOL; METHYL SALICYLATE 10; 15 mg/g; mg/g N 20181231 67777-417_70741340-4218-42e7-a74b-b44c182e413a 67777-417 HUMAN OTC DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20161007 OTC MONOGRAPH NOT FINAL part348 Dynarex Corporation HYDROCORTISONE 1 g/100g N 20181231 67777-419_b253603f-a821-4dfa-9d16-6ab6c90a4def 67777-419 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20160913 OTC MONOGRAPH FINAL part333C Dynarex Corporation POVIDONE-IODINE 10 mg/mL N 20181231 67777-420_acc53530-6c76-458c-b57f-1b92ac27c649 67777-420 HUMAN OTC DRUG povidine iodine povidine iodine SWAB TOPICAL 20160913 OTC MONOGRAPH FINAL part333C Dynarex Corporation POVIDONE-IODINE 10 g/100g N 20181231 67781-251_64f121d8-f082-471a-9756-cc5ac544543c 67781-251 HUMAN PRESCRIPTION DRUG Uniphyl theophylline anhydrous TABLET ORAL 19820901 ANDA ANDA087571 Purdue Pharmaceutical Products LP THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 67781-252_64f121d8-f082-471a-9756-cc5ac544543c 67781-252 HUMAN PRESCRIPTION DRUG Uniphyl theophylline anhydrous TABLET ORAL 19960607 ANDA ANDA040086 Purdue Pharmaceutical Products LP THEOPHYLLINE ANHYDROUS 600 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 67787-347_1f70335d-208e-4e49-a891-2182e4383be5 67787-347 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20151218 ANDA ANDA203455 InvaGen Pharmaceuticals Inc. NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67787-348_1f70335d-208e-4e49-a891-2182e4383be5 67787-348 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20151218 ANDA ANDA203455 InvaGen Pharmaceuticals Inc. NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67787-349_1f70335d-208e-4e49-a891-2182e4383be5 67787-349 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20151218 ANDA ANDA203455 InvaGen Pharmaceuticals Inc. NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67787-407_2a1c69d0-6ef6-4c0e-b32b-fd8f2dae5983 67787-407 HUMAN PRESCRIPTION DRUG Sevelamer carbonate SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20171026 ANDA ANDA203860 InvaGen Pharmaceuticals Inc. SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 67795-033_60c70d70-a9f6-7644-e053-2a91aa0a7cf6 67795-033 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20000110 UNAPPROVED MEDICAL GAS RoadRunner Oxygen Service, Inc. OXYGEN 99 L/100L N 20181231 67795-100_bdccab07-090e-4f6f-a578-014f3c9948c3 67795-100 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Roadrunner Oxygen Service NITROGEN 99 L/100L E 20171231 67840-0001_626f4e66-a9ad-3769-e053-2a91aa0a7116 67840-0001 HUMAN OTC DRUG Stress Less Aconitum nap., Ambra, Anacardium orientale, Arg. nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali phos., Nux vom., Sambucus nig., Strychninum, Theridion, Valeriana, Passiflora LIQUID ORAL 20180115 UNAPPROVED HOMEOPATHIC Stress Less, Inc. ACONITUM NAPELLUS; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; ASAFETIDA; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; BLACK COHOSH; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; HYOSCYAMUS NIGER; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; SAMBUCUS NIGRA FLOWERING TOP; STRYCHNINE; THERIDION CURASSAVICUM; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 67850-011_3c219760-e94e-de53-2b3a-2155fe2224b1 67850-011 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101018 ANDA ANDA090767 Methapharm, Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 67850-012_3c219760-e94e-de53-2b3a-2155fe2224b1 67850-012 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101018 ANDA ANDA090767 Methapharm, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 67850-013_3c219760-e94e-de53-2b3a-2155fe2224b1 67850-013 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101018 ANDA ANDA090767 Methapharm, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 67850-014_3c219760-e94e-de53-2b3a-2155fe2224b1 67850-014 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20101018 ANDA ANDA090767 Methapharm, Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 67857-700_8d674ec6-61e4-41f2-91f8-4a0df9c141b9 67857-700 HUMAN PRESCRIPTION DRUG SECTRAL acebutolol hydrochloride CAPSULE ORAL 19841228 NDA NDA018917 Promius Pharma, LLC ACEBUTOLOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67857-701_8d674ec6-61e4-41f2-91f8-4a0df9c141b9 67857-701 HUMAN PRESCRIPTION DRUG SECTRAL acebutolol hydrochloride CAPSULE ORAL 19841228 NDA NDA018917 Promius Pharma, LLC ACEBUTOLOL HYDROCHLORIDE 400 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67857-705_1b6fa629-ed24-8a9c-de2a-36bf69ea2e4d 67857-705 HUMAN PRESCRIPTION DRUG TENEX guanfacine hydrochloride TABLET ORAL 19861027 NDA NDA019032 Promius Pharma, LLC GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 67857-706_1b6fa629-ed24-8a9c-de2a-36bf69ea2e4d 67857-706 HUMAN PRESCRIPTION DRUG TENEX guanfacine hydrochloride TABLET ORAL 19861027 NDA NDA019032 Promius Pharma, LLC GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 67857-804_481a40ad-3f27-a615-1a4c-954b3d153b3a 67857-804 HUMAN PRESCRIPTION DRUG Cloderm clocortolone pivalate CREAM TOPICAL 19770822 NDA NDA017765 Promius Pharma, LLC CLOCORTOLONE PIVALATE .001 g/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67857-806_35ce2f4f-c6c1-966d-d5c8-15146b4ad736 67857-806 HUMAN PRESCRIPTION DRUG Trianex 0.05% Triamcinolone Acetonide Ointment OINTMENT TOPICAL 20150218 ANDA ANDA089595 Promius Pharma, LLC TRIAMCINOLONE ACETONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67857-808_d525ae51-df67-41f3-a9b2-1cc2f53637b1 67857-808 HUMAN PRESCRIPTION DRUG Sernivo betamethasone dipropionate SPRAY TOPICAL 20160222 NDA NDA208079 Promius Pharma, LLC BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67857-809_0da3f03b-2d31-664f-892d-7c4a6ef0c805 67857-809 HUMAN PRESCRIPTION DRUG ZEMBRACE SymTouch sumatriptan INJECTION, SOLUTION SUBCUTANEOUS 20160222 NDA NDA208223 Promius Pharma, LLC SUMATRIPTAN SUCCINATE 3 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 67857-811_7860aaf9-5f7d-dbcf-287a-dfd37d729269 67857-811 HUMAN PRESCRIPTION DRUG IMPOYZ Clobetasol Propionate CREAM TOPICAL 20180110 NDA NDA209483 Promius Pharma, LLC. CLOBETASOL PROPIONATE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67858-001_bb0d0cdf-8539-46f5-91fe-83e9873cb3bf 67858-001 HUMAN OTC DRUG Ovation Instant Hand Sanitizer Benzethonium chloride LIQUID TOPICAL 20110401 OTC MONOGRAPH NOT FINAL part333A QuestVapco Corporation BENZETHONIUM CHLORIDE 1 mg/50mL N 20181231 67858-515_21559649-01ea-40a3-a847-b399a55da3d5 67858-515 HUMAN OTC DRUG hand san INSTANT HAND SANITIZER HUSKY 515 GEL TOPICAL 20100321 OTC MONOGRAPH NOT FINAL part333 Environmental Chemical Inc. ALCOHOL 600 mL/1000mL E 20171231 67858-698_4d9da7b1-762f-0684-e054-00144ff88e88 67858-698 HUMAN OTC DRUG Deep Six Deep Six LIQUID TOPICAL 20170701 UNAPPROVED HOMEOPATHIC QuestSpecialty Corporation LECITHIN, SOYBEAN 1 [hp_X]/[hp_X] N 20181231 67860-072_3fde72da-bb63-4407-b6fc-43bdb9444d5b 67860-072 HUMAN OTC DRUG Antiseptic Mouthrinse Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20161118 OTC MONOGRAPH NOT FINAL part348 Cariba International EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67860-318_f6367419-3299-491b-ab2d-4a4246e456ea 67860-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20161107 OTC MONOGRAPH NOT FINAL part356 Cariba International EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67860-664_3e3653fd-c652-4965-a23e-429b8b6a25b4 67860-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20161108 OTC MONOGRAPH NOT FINAL part356 Cariba International EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 67860-686_35da7597-3409-4aae-86ca-8ce98662e90f 67860-686 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20161220 OTC MONOGRAPH NOT FINAL part334 Cariba International MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 67860-810_51651361-b92b-4356-9d3f-337f751c4bb5 67860-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part333A Cariba International ISOPROPYL ALCOHOL 500 mg/mL N 20181231 67860-845_614590a9-06ab-477c-937c-d18570159887 67860-845 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20161216 OTC MONOGRAPH FINAL part344 Cariba International ISOPROPYL ALCOHOL 613 mg/mL N 20181231 67860-871_17cd50be-3fb2-4d8e-8b47-08b883151023 67860-871 HUMAN OTC DRUG Hydrogen Peroxide HYDROGEN PEROXIDE SOLUTION TOPICAL 20161028 OTC MONOGRAPH NOT FINAL part333A Cariba International HYDROGEN PEROXIDE 30 mg/mL N 20181231 67868-054_bfa1413c-d38a-4d3b-b129-9eb5e323dec0 67868-054 HUMAN OTC DRUG Freds Antiseptic Wash BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20100708 OTC MONOGRAPH FINAL part333A Pharma Pac, LLC BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 20 mg/mL; mg/mL E 20171231 67868-117_d1f9eabc-99ec-4daa-a999-47aaca7d1aa0 67868-117 HUMAN OTC DRUG BENZOCAINE and RESORCINOL BENZOCAINE and RESORCINOL CREAM TOPICAL 20090519 OTC MONOGRAPH NOT FINAL part348 Pharma Pac, LLC BENZOCAINE; RESORCINOL 200; 20 mg/g; mg/g E 20171231 67871-007_6b61a6f9-0cc7-47bf-a600-ae8bb89a9501 67871-007 HUMAN PRESCRIPTION DRUG Elliotts B sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate INJECTION INTRATHECAL 20060927 NDA NDA020577 QOL Medical, LLC SODIUM CHLORIDE; SODIUM BICARBONATE; ANHYDROUS DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; SODIUM PHOSPHATE 73; 19; 8; 3; 3; 2; 2 mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 67871-111_8cd00770-2706-42e9-9e77-7f198d8b5748 67871-111 HUMAN PRESCRIPTION DRUG Sucraid sacrosidase SOLUTION ORAL 19980409 NDA NDA020772 QOL Medical, LLC SACROSIDASE 8500 [iU]/mL Sucrose-specific Enzyme [EPC] E 20171231 67871-479_c863b995-b91f-4ee3-b9a4-493cf812f722 67871-479 HUMAN PRESCRIPTION DRUG Ethamolin Ethanolamine Oleate INJECTION, SOLUTION INTRAVENOUS 19981222 NDA NDA019357 QOL Medical, LLC. ETHANOLAMINE OLEATE 50 mg/mL Sclerosing Activity [MoA],Sclerosing Agent [EPC],Vascular Sclerosing Activity [PE] E 20171231 67877-105_b1b57d59-f4ca-4c46-96af-babcb201317d 67877-105 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Ascend Laboratories LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67877-106_b1b57d59-f4ca-4c46-96af-babcb201317d 67877-106 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 Ascend Laboratories LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67877-116_7e143b13-423f-4be3-a49b-a2244d3996dc 67877-116 HUMAN PRESCRIPTION DRUG Methadone Hydrochloride Methadone Hydrochloride TABLET ORAL 20120116 ANDA ANDA090635 Ascend Laboratories, LLC METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 67877-119_95a71bca-6bdd-4a52-bab5-96bce3c03c21 67877-119 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20090206 ANDA ANDA078329 Ascend Laboratories, LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67877-120_95a71bca-6bdd-4a52-bab5-96bce3c03c21 67877-120 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20090206 ANDA ANDA078329 Ascend Laboratories, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67877-121_95a71bca-6bdd-4a52-bab5-96bce3c03c21 67877-121 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20090206 ANDA ANDA078329 Ascend Laboratories, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67877-124_6d34fb88-861c-4ff2-82fd-aeb99f84f735 67877-124 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 Ascend Laboratories, LLC SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 67877-128_b1b57d59-f4ca-4c46-96af-babcb201317d 67877-128 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20150209 ANDA ANDA201209 Ascend Laboratories LLC BENZONATATE 150 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67877-146_9000c23c-594b-4823-9aab-e406fc7fbbd5 67877-146 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071456 Ascend Laboratories, LLC TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67877-147_9000c23c-594b-4823-9aab-e406fc7fbbd5 67877-147 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 19870421 ANDA ANDA071457 Ascend Laboratories, LLC TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67877-148_9000c23c-594b-4823-9aab-e406fc7fbbd5 67877-148 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120628 ANDA ANDA071457 Ascend Laboratories, LLC TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67877-149_9000c23c-594b-4823-9aab-e406fc7fbbd5 67877-149 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120628 ANDA ANDA071457 Ascend Laboratories, LLC TEMAZEPAM 22.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 67877-159_799fcae7-07d4-41fa-a1e2-5873a77c56e7 67877-159 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20130301 ANDA ANDA201991 Ascend Laboratories, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67877-164_586ed13a-20fc-4660-a220-7d0e966d3313 67877-164 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110622 ANDA ANDA200694 Ascend Laboratories, LLC LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67877-165_586ed13a-20fc-4660-a220-7d0e966d3313 67877-165 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110622 ANDA ANDA200694 Ascend Laboratories, LLC LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67877-166_586ed13a-20fc-4660-a220-7d0e966d3313 67877-166 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110622 ANDA ANDA200694 Ascend Laboratories, LLC LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67877-167_586ed13a-20fc-4660-a220-7d0e966d3313 67877-167 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20110622 ANDA ANDA200694 Ascend Laboratories, LLC LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 67877-169_48f2e53d-f154-4ebf-b7cb-2d17a452f20b 67877-169 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Ascend Laboratories, LLC ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 67877-170_48f2e53d-f154-4ebf-b7cb-2d17a452f20b 67877-170 HUMAN PRESCRIPTION DRUG ondansetron ondansetron hydrochloride TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Ascend Laboratories, LLC ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 67877-171_0952644e-ef42-4dcb-b07f-6901cda78ec0 67877-171 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA079220 Ascend Laboratories, LLC ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 67877-171_4dcb2dbc-c4c1-43a4-950d-b24062e4d174 67877-171 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100628 ANDA ANDA079220 Ascend Laboratories, LLC ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 67877-172_f2e5f8bb-71d5-4b3c-92fd-c0657ff73fa1 67877-172 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120101 ANDA ANDA202295 Ascend Laboratories, LLC OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 67877-173_f2e5f8bb-71d5-4b3c-92fd-c0657ff73fa1 67877-173 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120101 ANDA ANDA202295 Ascend Laboratories, LLC OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 67877-174_f2e5f8bb-71d5-4b3c-92fd-c0657ff73fa1 67877-174 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120102 ANDA ANDA202295 Ascend Laboratories, LLC OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 67877-175_f2e5f8bb-71d5-4b3c-92fd-c0657ff73fa1 67877-175 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120101 ANDA ANDA202295 Ascend Laboratories, LLC OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 67877-176_f2e5f8bb-71d5-4b3c-92fd-c0657ff73fa1 67877-176 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120101 ANDA ANDA202295 Ascend Laboratories, LLC OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] E 20171231 67877-177_f2e5f8bb-71d5-4b3c-92fd-c0657ff73fa1 67877-177 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20120101 ANDA ANDA202295 Ascend Laboratories, LLC OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] E 20171231 67877-184_de33da5e-1833-4875-915c-578380409b54 67877-184 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET ORAL 20100101 ANDA ANDA078969 Ascend Laboratories, LLC GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 67877-197_d50fc0fa-b4d7-4e7e-bfaf-5c4db88bb528 67877-197 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20101020 ANDA ANDA078925 Ascend Laboratories, LLC AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67877-198_d50fc0fa-b4d7-4e7e-bfaf-5c4db88bb528 67877-198 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20101020 ANDA ANDA078925 Ascend Laboratories, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67877-199_d50fc0fa-b4d7-4e7e-bfaf-5c4db88bb528 67877-199 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20101020 ANDA ANDA078925 Ascend Laboratories, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67877-210_2f44db39-e1d9-451e-ba31-e4b10366a430 67877-210 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20101215 ANDA ANDA078989 Ascend Laboratories, LLC ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 67877-211_2f44db39-e1d9-451e-ba31-e4b10366a430 67877-211 HUMAN PRESCRIPTION DRUG ZALEPLON ZALEPLON CAPSULE ORAL 20101215 ANDA ANDA078989 Ascend Laboratories, LLC ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV E 20171231 67877-215_3784c30a-6812-4c27-ba9b-9f6942165a84 67877-215 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET, FILM COATED ORAL 20101201 ANDA ANDA065496 Ascend Laboratories, LLC CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67877-216_3784c30a-6812-4c27-ba9b-9f6942165a84 67877-216 HUMAN PRESCRIPTION DRUG Cefuroxime axetil Cefuroxime axetil TABLET, FILM COATED ORAL 20101201 ANDA ANDA065496 Ascend Laboratories, LLC CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67877-217_2e345ac3-4c88-4f42-9416-6e2528c9dff0 67877-217 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Ascend Laboratories, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67877-218_2e345ac3-4c88-4f42-9416-6e2528c9dff0 67877-218 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Ascend Laboratories, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67877-219_f8f6aaf1-3b24-4eab-80e3-686844f63dec 67877-219 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110119 ANDA ANDA090836 Ascend Laboratories, LLC CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67877-220_f8f6aaf1-3b24-4eab-80e3-686844f63dec 67877-220 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20110120 ANDA ANDA090836 Ascend Laboratories, LLC CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67877-221_2e345ac3-4c88-4f42-9416-6e2528c9dff0 67877-221 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Ascend Laboratories, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67877-222_225864e8-2f16-44da-919b-c5e655b2e4aa 67877-222 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Ascend Laboratories, LLC GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67877-223_225864e8-2f16-44da-919b-c5e655b2e4aa 67877-223 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Ascend Laboratories, LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67877-224_225864e8-2f16-44da-919b-c5e655b2e4aa 67877-224 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 Ascend Laboratories, LLC GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67877-225_0ba16b30-8bb2-4d6a-8d40-50844323e6a9 67877-225 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET, FILM COATED ORAL 20111128 ANDA ANDA091249 Ascend Laboratories, LLC MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 67877-229_4803da82-c0c2-4c1b-bb89-3bc39585058d 67877-229 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION OPHTHALMIC 20110309 ANDA ANDA077259 Ascend Laboratories, LLC TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 67877-230_33cba841-0e92-4f09-80d5-b14f4f2af9b4 67877-230 HUMAN PRESCRIPTION DRUG Mycophenolate mofetil Mycophenolate mofetil POWDER, FOR SUSPENSION ORAL 20141117 ANDA ANDA203005 Ascend Laboratories, LLC MYCOPHENOLATE MOFETIL 200 mg/mL Antimetabolite Immunosuppressant [EPC] N 20181231 67877-242_f95c79df-c1af-46cc-a091-bda8f3928483 67877-242 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 67877-245_f95c79df-c1af-46cc-a091-bda8f3928483 67877-245 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 67877-246_f95c79df-c1af-46cc-a091-bda8f3928483 67877-246 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 67877-247_f95c79df-c1af-46cc-a091-bda8f3928483 67877-247 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 67877-248_f95c79df-c1af-46cc-a091-bda8f3928483 67877-248 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 67877-249_f95c79df-c1af-46cc-a091-bda8f3928483 67877-249 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 67877-250_f95c79df-c1af-46cc-a091-bda8f3928483 67877-250 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 Ascend Laboratories, LLC QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 67877-251_3c40e020-78db-48bf-8460-c92032863cf6 67877-251 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Ascend Laboratories, LLC TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67877-254_f8f6aaf1-3b24-4eab-80e3-686844f63dec 67877-254 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120604 ANDA ANDA090836 Ascend Laboratories, LLC CEPHALEXIN 333 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67877-255_f8f6aaf1-3b24-4eab-80e3-686844f63dec 67877-255 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20120604 ANDA ANDA090836 Ascend Laboratories, LLC CEPHALEXIN 750 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 67877-259_f21a6e0e-6778-4871-9d11-756a969f0e24 67877-259 HUMAN PRESCRIPTION DRUG Rasagiline Rasagiline TABLET ORAL 20171030 ANDA ANDA201889 Ascend Laboratories, LLC RASAGILINE MESYLATE .5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 67877-260_f21a6e0e-6778-4871-9d11-756a969f0e24 67877-260 HUMAN PRESCRIPTION DRUG Rasagiline Rasagiline TABLET ORAL 20171030 ANDA ANDA201889 Ascend Laboratories, LLC RASAGILINE MESYLATE 1 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 67877-261_d750a286-35ac-4fc5-ba80-24e95e8aef53 67877-261 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20120625 ANDA ANDA203269 Ascend Laboratories, LLC RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 67877-262_d750a286-35ac-4fc5-ba80-24e95e8aef53 67877-262 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20120625 ANDA ANDA203269 Ascend Laboratories, LLC RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 67877-263_a4563003-d983-4b16-b3a0-2789918dfca1 67877-263 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20120501 ANDA ANDA203197 Ascend Laboratories, LLC DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67877-264_a4563003-d983-4b16-b3a0-2789918dfca1 67877-264 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20120501 ANDA ANDA203197 Ascend Laboratories, LLC DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67877-265_a4563003-d983-4b16-b3a0-2789918dfca1 67877-265 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20120501 ANDA ANDA203197 Ascend Laboratories, LLC DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 67877-266_0ba16b30-8bb2-4d6a-8d40-50844323e6a9 67877-266 HUMAN PRESCRIPTION DRUG mycophenolate mofetil mycophenolate mofetil CAPSULE ORAL 20100101 ANDA ANDA200197 Ascend Laboratories, LLC MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 67877-286_1d240995-d181-4f56-9196-054e6956c018 67877-286 HUMAN PRESCRIPTION DRUG Riluzole Riluzole TABLET ORAL 20160331 ANDA ANDA204048 Ascend Laboratories, LLC RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] N 20181231 67877-288_a93452d8-bcba-4e4e-bbaa-6401f7e183c7 67877-288 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20170105 ANDA ANDA204304 Ascend Laboratories, LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 67877-290_26a904df-7070-489e-b0e0-67167a817944 67877-290 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100524 ANDA ANDA200737 Ascend Laboratories, LLC HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 67877-291_26a904df-7070-489e-b0e0-67167a817944 67877-291 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20091124 ANDA ANDA200737 Ascend Laboratories, LLC HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 67877-292_26a904df-7070-489e-b0e0-67167a817944 67877-292 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100524 ANDA ANDA200737 Ascend Laboratories, LLC HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 67877-293_26a904df-7070-489e-b0e0-67167a817944 67877-293 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100524 ANDA ANDA200737 Ascend Laboratories, LLC HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 67877-294_38dfdb8f-cc61-4b00-af82-c272cbf376e0 67877-294 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120222 ANDA ANDA090796 Ascend Laboratories, LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67877-295_24a5ca32-06d7-499a-bef6-1958cee5f246 67877-295 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120222 ANDA ANDA090796 Ascend Laboratories, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67877-295_38dfdb8f-cc61-4b00-af82-c272cbf376e0 67877-295 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120222 ANDA ANDA090796 Ascend Laboratories, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67877-296_38dfdb8f-cc61-4b00-af82-c272cbf376e0 67877-296 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120222 ANDA ANDA090796 Ascend Laboratories, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67877-297_42744d16-cc4a-421e-a23b-b22aceab7a57 67877-297 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE, LIQUID FILLED ORAL 20150101 ANDA ANDA090103 Ascend Laboratories, LLC NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67877-317_3c40e020-78db-48bf-8460-c92032863cf6 67877-317 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Ascend Laboratories, LLC TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67877-318_3c40e020-78db-48bf-8460-c92032863cf6 67877-318 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 Ascend Laboratories, LLC TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 67877-319_2e88baa1-a830-45e7-bd17-9105b4abb20b 67877-319 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 Ascend Laboratories, LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67877-320_2e88baa1-a830-45e7-bd17-9105b4abb20b 67877-320 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 Ascend Laboratories, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67877-321_2e88baa1-a830-45e7-bd17-9105b4abb20b 67877-321 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 Ascend Laboratories, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 67877-322_34498c95-abf4-4ff5-8b9d-2e762aab0d20 67877-322 HUMAN PRESCRIPTION DRUG Tramadol HCl and Acetaminophen Tramadol HCl and Acetaminophen TABLET, FILM COATED ORAL 20160615 ANDA ANDA202076 Ascend Laboratories, LLC TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 67877-419_a95c312f-fd9e-4a0b-8606-deffbd881228 67877-419 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20151221 ANDA ANDA205517 Ascend Laboratories, LLC LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 67877-428_043e6af1-5d16-46a2-9ca3-e6e3db446cb5 67877-428 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20151101 ANDA ANDA206402 Ascend Laboratories, LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67877-429_043e6af1-5d16-46a2-9ca3-e6e3db446cb5 67877-429 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20151101 ANDA ANDA206402 Ascend Laboratories, LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 67877-439_be25cd45-b57a-40c4-850e-88b8583f4c6c 67877-439 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20170321 ANDA ANDA206465 Ascend Laboratories, LLC ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67877-440_be25cd45-b57a-40c4-850e-88b8583f4c6c 67877-440 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20170321 ANDA ANDA206465 Ascend Laboratories, LLC ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67877-441_be25cd45-b57a-40c4-850e-88b8583f4c6c 67877-441 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20170321 ANDA ANDA206465 Ascend Laboratories, LLC ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67877-442_be25cd45-b57a-40c4-850e-88b8583f4c6c 67877-442 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20170321 ANDA ANDA206465 Ascend Laboratories, LLC ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 67877-445_1a3e1d2b-7348-40cf-a3d1-5b44d6b8f3a8 67877-445 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, COATED ORAL 20170424 ANDA ANDA206763 Ascend Laboratories, LLC OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67877-446_1a3e1d2b-7348-40cf-a3d1-5b44d6b8f3a8 67877-446 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, COATED ORAL 20170424 ANDA ANDA206763 Ascend Laboratories, LLC OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67877-447_1a3e1d2b-7348-40cf-a3d1-5b44d6b8f3a8 67877-447 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, COATED ORAL 20170424 ANDA ANDA206763 Ascend Laboratories, LLC OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67877-450_3785c775-291e-4114-85b1-6dae4c7fa5cb 67877-450 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20170811 ANDA ANDA207405 Ascend Laboratories, LLC TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 67877-454_1165e4a9-4f0b-4950-b6a0-0bd7ab2a5723 67877-454 HUMAN PRESCRIPTION DRUG Itraconazole Itraconazole CAPSULE, COATED PELLETS ORAL 20170612 ANDA ANDA208591 Ascend Laboratories, LLC ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 67877-455_8ef41896-e58a-4345-8ece-36d91cd5125e 67877-455 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, COATED ORAL 20170106 ANDA ANDA207750 Ascend Laboratories, LLC FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 67877-458_d6417cc0-8109-42fb-ae2f-34b72129b57c 67877-458 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20171125 ANDA ANDA207652 Ascend Laboratories, LLC CAPECITABINE 150 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 67877-459_d6417cc0-8109-42fb-ae2f-34b72129b57c 67877-459 HUMAN PRESCRIPTION DRUG Capecitabine Capecitabine TABLET, FILM COATED ORAL 20171125 ANDA ANDA207652 Ascend Laboratories, LLC CAPECITABINE 500 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 67877-470_3771151d-91e7-4da8-af0a-b39f1db56292 67877-470 HUMAN PRESCRIPTION DRUG TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM TOPICAL 20171228 ANDA ANDA207651 Ascend Laboratories, LLC TRIAMCINOLONE .25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 67877-471_3771151d-91e7-4da8-af0a-b39f1db56292 67877-471 HUMAN PRESCRIPTION DRUG TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM TOPICAL 20171228 ANDA ANDA207651 Ascend Laboratories, LLC TRIAMCINOLONE 1 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 67877-472_3771151d-91e7-4da8-af0a-b39f1db56292 67877-472 HUMAN PRESCRIPTION DRUG TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE CREAM TOPICAL 20171228 ANDA ANDA207651 Ascend Laboratories, LLC TRIAMCINOLONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 67877-473_5ae6c278-5961-4f2a-9039-329bf5b20477 67877-473 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20170310 ANDA ANDA207810 Ascend Laboratories, LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 67877-477_b3299494-dd1f-4a30-a8d9-f0ca9020411b 67877-477 HUMAN PRESCRIPTION DRUG Azelastine Azelastine SPRAY, METERED NASAL 20170818 ANDA ANDA208156 Ascend Laboratories, LLC AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 67877-478_9b3b880c-dc1f-4431-b017-1bb5c93d5765 67877-478 HUMAN PRESCRIPTION DRUG Esomeprazole magnesium Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20171020 ANDA ANDA208333 Ascend Laboratories, LLC ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 67877-479_9b3b880c-dc1f-4431-b017-1bb5c93d5765 67877-479 HUMAN PRESCRIPTION DRUG Esomeprazole magnesium Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20171020 ANDA ANDA208333 Ascend Laboratories, LLC ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 67877-482_751fffa3-fc64-4b1f-9212-7f3f055a78eb 67877-482 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20160612 ANDA ANDA205150 Ascend Laboratories, LLC TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67877-483_751fffa3-fc64-4b1f-9212-7f3f055a78eb 67877-483 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20160612 ANDA ANDA205150 Ascend Laboratories, LLC TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67877-484_751fffa3-fc64-4b1f-9212-7f3f055a78eb 67877-484 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20160612 ANDA ANDA205150 Ascend Laboratories, LLC TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67877-490_c7d0eb99-2f76-4d62-8d1f-9fd552e3b22b 67877-490 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20171223 ANDA ANDA209234 Ascend Laboratories, LLC EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20191231 67877-499_0b2373f3-3db3-4b6b-a999-1f7ab4fbbe38 67877-499 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan Medoxomil Amlodipine and olmesartan Medoxomil TABLET ORAL 20170814 ANDA ANDA209042 Ascend Laboratories, LLC AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 67877-500_0b2373f3-3db3-4b6b-a999-1f7ab4fbbe38 67877-500 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan Medoxomil Amlodipine and olmesartan Medoxomil TABLET ORAL 20170814 ANDA ANDA209042 Ascend Laboratories, LLC AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67877-501_0b2373f3-3db3-4b6b-a999-1f7ab4fbbe38 67877-501 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan Medoxomil Amlodipine and olmesartan Medoxomil TABLET ORAL 20170814 ANDA ANDA209042 Ascend Laboratories, LLC AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67877-502_0b2373f3-3db3-4b6b-a999-1f7ab4fbbe38 67877-502 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan Medoxomil Amlodipine and olmesartan Medoxomil TABLET ORAL 20170814 ANDA ANDA209042 Ascend Laboratories, LLC AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 67877-507_a6783d54-a5f2-4955-921a-b3c899fe511a 67877-507 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20171224 ANDA ANDA209222 Ascend Laboratories, LLC EZETIMIBE; SIMVASTATIN 10; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 67877-508_a6783d54-a5f2-4955-921a-b3c899fe511a 67877-508 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20171224 ANDA ANDA209222 Ascend Laboratories, LLC EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 67877-509_a6783d54-a5f2-4955-921a-b3c899fe511a 67877-509 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20171224 ANDA ANDA209222 Ascend Laboratories, LLC EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 67877-510_a6783d54-a5f2-4955-921a-b3c899fe511a 67877-510 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20171224 ANDA ANDA209222 Ascend Laboratories, LLC EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 67877-537_4f2ccb25-52e5-4234-9d38-a257e7329cbc 67877-537 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170428 ANDA ANDA207658 Ascend Laboratories, LLC TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 67877-538_4f2ccb25-52e5-4234-9d38-a257e7329cbc 67877-538 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170428 ANDA ANDA207658 Ascend Laboratories, LLC TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 67877-539_4f2ccb25-52e5-4234-9d38-a257e7329cbc 67877-539 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170428 ANDA ANDA207658 Ascend Laboratories, LLC TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 67877-540_4f2ccb25-52e5-4234-9d38-a257e7329cbc 67877-540 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170428 ANDA ANDA207658 Ascend Laboratories, LLC TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 67877-541_4f2ccb25-52e5-4234-9d38-a257e7329cbc 67877-541 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170428 ANDA ANDA207658 Ascend Laboratories, LLC TEMOZOLOMIDE 180 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 67877-542_4f2ccb25-52e5-4234-9d38-a257e7329cbc 67877-542 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20170428 ANDA ANDA207658 Ascend Laboratories, LLC TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 67877-561_2d98aea3-35ba-447a-b88f-a5a20b612b2f 67877-561 HUMAN PRESCRIPTION DRUG Metformin HCl Metformin HCl TABLET ORAL 20170206 ANDA ANDA090564 Ascend Laboratories, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67877-562_2d98aea3-35ba-447a-b88f-a5a20b612b2f 67877-562 HUMAN PRESCRIPTION DRUG Metformin HCl Metformin HCl TABLET ORAL 20170206 ANDA ANDA090564 Ascend Laboratories, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67877-563_2d98aea3-35ba-447a-b88f-a5a20b612b2f 67877-563 HUMAN PRESCRIPTION DRUG Metformin HCl Metformin HCl TABLET ORAL 20170206 ANDA ANDA090564 Ascend Laboratories, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 67877-568_ce376467-5c55-dec5-7bae-a24ee2510aef 67877-568 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20170510 NDA NDA018651 Ascend Laboratories, LLC DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 67877-569_ce376467-5c55-dec5-7bae-a24ee2510aef 67877-569 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20170510 NDA NDA018651 Ascend Laboratories, LLC DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 67877-570_ce376467-5c55-dec5-7bae-a24ee2510aef 67877-570 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20170510 NDA NDA018651 Ascend Laboratories, LLC DRONABINOL 10 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 67877-573_2813b0d3-d461-4b3e-823b-e1cc788f426b 67877-573 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040627 Ascend Laboratories LLC BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67877-574_2813b0d3-d461-4b3e-823b-e1cc788f426b 67877-574 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA201209 Ascend Laboratories LLC BENZONATATE 150 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67877-575_2813b0d3-d461-4b3e-823b-e1cc788f426b 67877-575 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040749 Ascend Laboratories LLC BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 67877-576_92d17b1d-cb90-4442-9c05-27345ec61023 67877-576 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160930 ANDA ANDA204453 Ascend Laboratories, LLC MINOCYCLINE HYDROCHLORIDE 90 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 67877-577_92d17b1d-cb90-4442-9c05-27345ec61023 67877-577 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160930 ANDA ANDA204453 Ascend Laboratories, LLC MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 67877-578_92d17b1d-cb90-4442-9c05-27345ec61023 67877-578 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160930 ANDA ANDA204453 Ascend Laboratories, LLC MINOCYCLINE HYDROCHLORIDE 45 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 67877-604_91138d34-36ca-4854-a514-362cd6001a73 67877-604 HUMAN PRESCRIPTION DRUG PRASUGREL Prasugrel TABLET, FILM COATED ORAL 20171017 ANDA ANDA205790 Ascend Laboratories, LLC PRASUGREL HYDROCHLORIDE 5 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 67877-605_91138d34-36ca-4854-a514-362cd6001a73 67877-605 HUMAN PRESCRIPTION DRUG PRASUGREL Prasugrel TABLET, FILM COATED ORAL 20171017 ANDA ANDA205790 Ascend Laboratories, LLC PRASUGREL HYDROCHLORIDE 10 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA] N 20181231 67879-101_679aee5c-96d8-446f-88c7-452f5eda92fd 67879-101 HUMAN OTC DRUG PHARMA CLEAR CLEANSER SALICYLIC ACID GEL TOPICAL 20150618 OTC MONOGRAPH FINAL part333D PHARMAGEL INTERNATIONAL INC SALICYLIC ACID 2 g/100mL E 20171231 67879-102_161407b9-7748-4240-8b2b-bfccaf6e3173 67879-102 HUMAN OTC DRUG PHARMA CLEAR ACNE TREATMENT SALICYLIC ACID CONCENTRATE TOPICAL 20150618 OTC MONOGRAPH FINAL part333D PHARMAGEL INTERNATIONAL INC SALICYLIC ACID 2 g/100mL E 20171231 67879-103_b060bcde-1587-4614-a9cb-0cdfc04d5abb 67879-103 HUMAN OTC DRUG PHARMA CLEAR MOISTURIZER SALICYLIC ACID LOTION TOPICAL 20150618 OTC MONOGRAPH FINAL part358H PHARMAGEL INTERNATIONAL INC SALICYLIC ACID 1 g/100mL E 20171231 67879-104_308fda0f-ef3f-462a-b5d3-fc273e954f60 67879-104 HUMAN OTC DRUG PHARMA CLEAR SPOT TREATMENT SALICYLIC ACID LIQUID TOPICAL 20160615 OTC MONOGRAPH FINAL part333D PHARMAGEL INTERNATIONAL INC SALICYLIC ACID 2 g/100mL E 20171231 67879-201_efb683ed-5dae-4a41-a945-7a06c0c2a119 67879-201 HUMAN OTC DRUG HAND THERAPE SANITIZER BENZETHONIUM CHLORIDE GEL TOPICAL 20150618 OTC MONOGRAPH NOT FINAL part333A PHARMAGEL INTERNATIONAL INC BENZETHONIUM CHLORIDE .2 g/100mL E 20171231 67879-301_ad1de504-2eb8-4154-a977-82659e16b2e4 67879-301 HUMAN OTC DRUG DERMA FADE OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20150618 OTC MONOGRAPH NOT FINAL part352 PHARMAGEL INTERNATIONAL INC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 g/100g; g/100g; g/100g E 20171231 67879-302_c7a0b710-c0b5-4645-b405-4f1870331c8c 67879-302 HUMAN OTC DRUG SUN THERAPE FACE SPF-35 OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE LOTION TOPICAL 20150618 OTC MONOGRAPH FINAL part352 PHARMAGEL INTERNATIONAL INC OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 7.5; 5; 3; 3 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 67879-303_0811eb1d-a929-4f85-aea2-ec427eb4550b 67879-303 HUMAN OTC DRUG SUN THERAPE BODY SPF-35 HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE LOTION TOPICAL 20150618 OTC MONOGRAPH FINAL part352 PHARMAGEL INTERNATIONAL INC HOMOSALATE; OCTINOXATE; OCTISALATE; AVOBENZONE 10; 7.5; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 67879-304_3cdb4d3e-d2fd-43f9-b378-7ef4ba0d0b70 67879-304 HUMAN OTC DRUG SUN THERAPE SPORT SPF-35 HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTOCRYLENE, OCTISALATE, AVOBENZONE SPRAY TOPICAL 20150618 OTC MONOGRAPH FINAL part352 PHARMAGEL INTERNATIONAL INC HOMOSALATE; OCTINOXATE; OXYBENZONE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 15; 7.5; 6; 5.5; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 67879-305_1fa11bc4-ba0c-4602-bcef-7031e718f1ba 67879-305 HUMAN OTC DRUG SUN THERAPE PRO SPORT FACE AND BODY SPF-35 OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE CREAM TOPICAL 20160609 OTC MONOGRAPH FINAL part352 PHARMAGEL INTERNATIONAL INC OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE 7.5; 3; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 67879-306_fa886a13-b00f-4c09-85ca-d196d360ff9a 67879-306 HUMAN OTC DRUG SUN THERAPE PRO SPORT SPF-35 HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTOCRYLENE, OCTISALATE, AVOBENZONE SPRAY TOPICAL 20160610 OTC MONOGRAPH FINAL part352 PHARMAGEL INTERNATIONAL INC HOMOSALATE; OCTINOXATE; OXYBENZONE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 15; 7.5; 6; 5.5; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 67879-307_323a4f68-57e2-4812-9d7b-6b3c46092f8d 67879-307 HUMAN OTC DRUG LIP RECOVERY PETROLATUM OINTMENT TOPICAL 20150618 OTC MONOGRAPH FINAL part347 PHARMAGEL INTERNATIONAL INC PETROLATUM 48 g/100mL E 20171231 67879-308_dda1fa5a-f9ee-414d-ad5c-cf0fdaaef37a 67879-308 HUMAN OTC DRUG DERMA BRITE SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20150618 OTC MONOGRAPH NOT FINAL part352 PHARMAGEL INTERNATIONAL INC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 g/100g; g/100g; g/100g E 20171231 67879-309_68031467-9aa5-4dd6-a886-01f41cb9c21f 67879-309 HUMAN OTC DRUG SUN THERAPE FACE AND BODY SPF-35 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20150618 OTC MONOGRAPH FINAL part352 PHARMAGEL INTERNATIONAL INC OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 7.5; 5; 3; 3 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 67905-0001_dc2c7562-dfe3-44c0-b849-a9bb7d267450 67905-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20091014 UNAPPROVED MEDICAL GAS Osborn Drugs Inc OXYGEN 99 L/100L E 20171231 67919-011_978ffcd1-aa87-4d91-8966-8332e1316bc0 67919-011 HUMAN PRESCRIPTION DRUG Cubicin Daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20030912 NDA NDA021572 Merck Sharp & Dohme Corp. DAPTOMYCIN 500 mg/10mL Lipopeptide Antibacterial [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 67919-012_a4b88d67-07ab-4bab-9612-3d5fcdbec518 67919-012 HUMAN PRESCRIPTION DRUG CUBICIN RF Daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160913 NDA NDA021572 Merck Sharp & Dohme Corp. DAPTOMYCIN 500 mg/10mL Lipopeptide Antibacterial [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 67919-012_d677cd8d-bd90-4541-9da9-21287ab2e94c 67919-012 HUMAN PRESCRIPTION DRUG CUBICIN RF Daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160706 NDA NDA021572 Merck Sharp & Dohme Corp. DAPTOMYCIN 500 mg/10mL Lipopeptide Antibacterial [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 67919-020_71ec574e-4b7b-4f58-8577-da61fd5506d7 67919-020 HUMAN PRESCRIPTION DRUG Entereg alvimopan CAPSULE ORAL 20120416 NDA NDA021775 Merck Sharp & Dohme Corp. ALVIMOPAN 12 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 67919-030_63e258f2-8cb7-4346-aef4-a1df551aa3fa 67919-030 HUMAN PRESCRIPTION DRUG ZERBAXA ceftolozane and tazobactam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20141219 NDA NDA206829 Merck Sharp & Dohme Corp. CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM 1; .5 g/10mL; g/10mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 67919-040_8b71a547-6995-4f68-b44b-92b749bab1c1 67919-040 HUMAN PRESCRIPTION DRUG SIVEXTRO tedizolid phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140620 NDA NDA205436 Merck Sharp & Dohme Corp. TEDIZOLID PHOSPHATE 200 mg/4mL Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 67919-041_8b71a547-6995-4f68-b44b-92b749bab1c1 67919-041 HUMAN PRESCRIPTION DRUG SIVEXTRO tedizolid phosphate TABLET, FILM COATED ORAL 20140620 NDA NDA205435 Merck Sharp & Dohme Corp. TEDIZOLID PHOSPHATE 200 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 67932-1313_08e3b327-50b4-4757-a012-61b4e02693d9 67932-1313 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19880101 UNAPPROVED MEDICAL GAS Premier Oxygen LLC OXYGEN 99.5 L/100L N 20181231 67938-0105_ada6ff1f-ad9e-4dc5-86a3-09a539a0da20 67938-0105 HUMAN OTC DRUG Eight Hour Cream Skin Protectant Petrolatum LOTION TOPICAL 20091103 OTC MONOGRAPH FINAL part347 Elizabeth Arden, Inc PETROLATUM 28.4 g/50g N 20181231 67938-0577_281b08c1-d524-47ba-9635-16ead1dcc9b6 67938-0577 HUMAN OTC DRUG Intervene Daily Moisture SPF 15 Oil Free OCTINOXATE and OXYBENZONE LOTION TOPICAL 20130924 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE 3600; 1800 mg/50mL; mg/50mL E 20171231 67938-0732_0f754894-4e0b-453b-b1fa-6af0e7e8db5a 67938-0732 HUMAN OTC DRUG Ceramide Time Complex Moisture Cream SPF 15 Octinoxate CREAM TOPICAL 20070327 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 3 g/50g E 20171231 67938-0772_42873170-b324-4670-a0c9-8b2baeba044f 67938-0772 HUMAN OTC DRUG Ceramide EyeWish Eye Sunscreen SPF 10 OCTINOXATE and OXYBENZONE CREAM TOPICAL 20060316 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE .852; .071 g/14.2g; g/14.2g E 20171231 67938-0774_1eef0736-09fc-40de-b8c0-a745842f4ea6 67938-0774 HUMAN OTC DRUG Eight Hour Cream Lip Protectant SPF 15 Petrolatum STICK TOPICAL 20060531 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc PETROLATUM; PADIMATE O; OXYBENZONE 1.12; .296; .111 g/3.7g; g/3.7g; g/3.7g N 20181231 67938-0801_ae6f4a9b-b4b6-4642-ac04-553fbd0571b9 67938-0801 HUMAN OTC DRUG Elizabeth Arden Moisture Shield SPF 15 Octinoxate LOTION TOPICAL 20060626 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 3.125; 2.5; 1; .75 mL/50mL; mL/50mL; mL/50mL; mL/50mL E 20171231 67938-0802_d0dedb46-ba65-4bc0-af6e-28a0d80f0778 67938-0802 HUMAN OTC DRUG Ceramide Lift And Firm Day Broad Spectrum Sunscreen SPF 30 OCTINOXATE, OXYBENZONE, OCTISALATE, and AVOBENZONE LOTION TOPICAL 20090227 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE; OCTISALATE; AVOBENZONE 3.75; 2.5; 2.5; 1 g/50g; g/50g; g/50g; g/50g N 20181231 67938-0808_3f4438b9-4b70-4c46-88b0-8daac18d00a4 67938-0808 HUMAN OTC DRUG Intervene Radiance Boosting Moisture SPF 15 Octinoxate LOTION TOPICAL 20090818 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; AVOBENZONE; OXYBENZONE 3.75; 1.5; 1.5 mL/50mL; mL/50mL; mL/50mL E 20171231 67938-0821_ab072a1f-93c7-4fb9-bdfa-6e1f7a7358e3 67938-0821 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Ivory Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0823_bdff6bd1-cd7f-4f41-a2a6-78f36c5ec0b1 67938-0823 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Cream Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0824_bcd7ff5d-04e1-4e91-ab12-57d4d3d1e325 67938-0824 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Cameo Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0825_ae7eb263-735f-4526-80b9-3741e750c8dd 67938-0825 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Bisque Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0826_87b3ccaf-2440-4136-883a-de2a42a613ed 67938-0826 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Buff Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0827_8eaa327b-5393-4bb9-8dd4-c6092f755586 67938-0827 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Honey Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0828_1a2c11d0-4343-43d8-896b-e963b37ed07f 67938-0828 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Fawn Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0830_a5ec33a9-475f-4c03-a317-84e0be04f11e 67938-0830 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Beige Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0831_82b419d0-04a2-45f1-9b5a-97d35ea5fecf 67938-0831 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Mocha Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0834_b0462d94-f054-46e3-b44d-01bac0efc22f 67938-0834 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Camellia Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0858_023c7728-8edf-480d-a7b0-c95ed8775065 67938-0858 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Toasty Beige Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0859_271a0451-07d4-4e0d-8a24-439dda4eb863 67938-0859 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Honey Beige Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0860_b5136a5c-eb17-4cf8-af67-3be426d3d7d9 67938-0860 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Perfect Beige Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-0866_ef12b107-049f-43c9-acaa-552bda7c8fdb 67938-0866 HUMAN OTC DRUG Eight Hour Cream Intensive Daily Moisturizer For Face SPF 15 Octinoxate CREAM TOPICAL 20081006 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE; AVOBENZONE 2.94; 1.47; .98 g/49g; g/49g; g/49g N 20181231 67938-0904_9f69f4f0-b49a-4b08-b3fe-691cf0fa03d3 67938-0904 HUMAN OTC DRUG Prevage Anti Aging Moisture Broad Spectrum Sunscreen SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, and AVOBENZONE LOTION TOPICAL 20090604 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 35; 25; 25; 11; 10 mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 67938-0906_b096eeb9-8445-4bad-b2d7-a5604456fc5a 67938-0906 HUMAN OTC DRUG Pure Finish Mineral Tinted Moisturizer SPF 15 Fair Octinoxate LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 3; 2.15; 2 mL/50mL; mL/50mL; mL/50mL N 20181231 67938-0907_2bb58a3e-805d-4a3a-8be7-0857fca1e68a 67938-0907 HUMAN OTC DRUG Pure Finish Mineral Tinted Moisturizer SPF 15 Light Octinoxate LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 3; 2.15; 2 mL/50mL; mL/50mL; mL/50mL N 20181231 67938-0908_d153c6d4-5408-4c0a-9ab3-5371220bc93c 67938-0908 HUMAN OTC DRUG Pure Finish Mineral Tinted Moisturizer SPF 15 Medium Octinoxate LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 3; 2.15; 2 mL/50mL; mL/50mL; mL/50mL N 20181231 67938-0909_644b092f-9fbf-466c-9471-0e3f2c42d0b5 67938-0909 HUMAN OTC DRUG Pure Finish Mineral Tinted Moisturizer SPF 15 Deep Octinoxate LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 3; 2.15; 2 mL/50mL; mL/50mL; mL/50mL N 20181231 67938-091_3d2ed268-8c53-483d-843d-04565252e06d 67938-091 HUMAN OTC DRUG Intervene Makeup SPF 15 Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-0936_f34b7f56-faeb-482c-b1f6-0c99812636e3 67938-0936 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 ECRU OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0937_4eb3d93a-214c-43b0-8fc4-627a86e0a2c3 67938-0937 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 VANILLA SHELL OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0938_c44bb9dc-e746-4b51-9377-f78298cd5b96 67938-0938 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 WARM SUNBEIGE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0939_5aa6217a-41ce-4a07-8acb-5513d5bd1536 67938-0939 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Sprectrum Sunscreen SPF 15 Sandstone OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0940_85e678d5-eeff-41ee-a538-0ccf6e25901b 67938-0940 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Cream OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0941_50fe6e7d-d4ee-4572-b58d-905197c618f7 67938-0941 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 BEIGE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0942_874949f8-8987-4f53-a35e-79dc0f8488f5 67938-0942 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 CAMEO OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0943_d28d41e3-8367-45a0-b51b-d27169efd707 67938-0943 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 BUFF OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0944_5cca93bc-f235-411c-90dc-a6d326d1aa59 67938-0944 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 WARM HONEY OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0945_81955ec0-5c29-43fc-977e-a4ba6d191584 67938-0945 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 BISQUE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0946_7429d99c-fc8f-4262-a137-0befc7475367 67938-0946 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 COGNAC OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0947_fabb9a74-ef89-4b17-86fc-e782f0cab3c1 67938-0947 HUMAN OTC DRUG Ceramide Lift And Firm Makeup Broad Spectrum Sunscreen SPF 15 Toast OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0948_442f8dcd-5129-4369-b0b8-750e394ec49d 67938-0948 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 MOCHA OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0949_73a238eb-503b-4502-ac7a-0cfee00951f5 67938-0949 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 WARM BRONZE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0950_ebb40664-e6cc-474a-b37e-ddf742247fd6 67938-0950 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 COCOA OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0951_aa9d1f8a-1d38-49fb-9f80-74dff27163df 67938-0951 HUMAN OTC DRUG Ceramide Lift and Firm Makeup Broad Spectrum Sunscreen SPF 15 Spice OCTINOXATE and TITANIUM DIOXIDE CREAM TOPICAL 20100805 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-0964_787b5e53-6a3b-4c2d-8387-fed1e9d0e350 67938-0964 HUMAN OTC DRUG Ceramide Lift And Firm Day Broad Spectrum Sunscreen SPF 30 OCTINOXATE, OXYBENZONE, OCTISALATE, OCTOCRYLENE, and AVOBENZONE CREAM TOPICAL 20090227 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 3.675; 2.45; 2.45; 1.078; .98 g/49g; g/49g; g/49g; g/49g; g/49g N 20181231 67938-0967_588818aa-fbaf-4526-a529-a86215802e29 67938-0967 HUMAN OTC DRUG Ceramide Plump Perfect Lip Moisture SPF 30 Octinoxate CREAM TOPICAL 20040430 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; AVOBENZONE; OXYBENZONE 1.091; .7275; .4365; .3928 g/14.55g; g/14.55g; g/14.55g; g/14.55g E 20171231 67938-0990_052fcac6-645a-447f-a693-43991bb4362f 67938-0990 HUMAN OTC DRUG Prevage Anti Agining Triple Defense Shield Broad Spectrum Sunscreen SPF 50 OCTINOXATE, OXYBENZONE, OCTISALATE, OCTOCRYLENE, and AVOBENZONE LOTION TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 75; 60; 50; 40; 30 mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL E 20171231 67938-0993_79efd427-1b07-4443-9b13-3665b646ed01 67938-0993 HUMAN OTC DRUG Ceramide Lift And Firm Eye Sunscreen SPF 15 OCTINOXATE and OXYBENZONE CREAM TOPICAL 20100427 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE .58896; .2016 g/14.4g; g/14.4g N 20181231 67938-1000_28434e69-3527-4030-bb7a-3f551a30bf9f 67938-1000 HUMAN OTC DRUG VISIBLE DIFFERENCE SKIN BALANCING SUNSCREEN SPF 15 OCTINOXATE and OXYBENZONE LOTION TOPICAL 20111116 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE 60; 30 mg/50mL; mg/50mL N 20181231 67938-102_9dff3920-a9a8-4071-9ed2-d96ebae108bd 67938-102 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g E 20171231 67938-1022_6e9d7251-4f6c-4f94-aaf9-47fcec4d3b52 67938-1022 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Vanilla Shell Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-1023_b07b9ceb-e5b9-41a6-bd88-3401fdaf054f 67938-1023 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Warm Sunbeige Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-1024_0aa1b448-db4c-42f9-870f-6ae910e22d32 67938-1024 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Warm Bronze Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-1025_2613eafe-5cff-4ba0-8ab5-871f34f4ec99 67938-1025 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Warm Cappuccino Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-1026_5f047c47-991a-4a6f-a706-a12ad0856767 67938-1026 HUMAN OTC DRUG Flawless Finish Bare Perfection Makeup SPF 8 Warm Mahogany Octinoxate LOTION TOPICAL 20110506 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.1988 mL/30mL E 20171231 67938-1044_7ea82ff0-45b3-4b0e-9d08-c10873534efa 67938-1044 HUMAN OTC DRUG Intervene Radiance Boosting Moisture SPF 15 Octinoxate CREAM TOPICAL 20090727 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; AVOBENZONE; OXYBENZONE 3.75; 1.5; 1.5 g/50g; g/50g; g/50g E 20171231 67938-1074_4ef908e8-5754-42bb-8dc3-d807bd5e5348 67938-1074 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Porcelain Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-1075_bd24d360-ba0f-439c-96bc-29a367fd3dbd 67938-1075 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Shell Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-1076_b0971fb3-4e62-4cd5-b027-57889a51aba2 67938-1076 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Sunbeige Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-1077_614e6cb3-f4a1-4e36-bdba-3562e34dbd2c 67938-1077 HUMAN OTC DRUG Intervene Makeup Broad Spectrum Sunscreen SPF 15 Soft Cream OCTINOXATE CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 g/30g E 20171231 67938-1078_de160499-21c9-4076-a448-9cd8f4ba4f48 67938-1078 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Sand Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-1079_ddf42248-de19-4cae-9950-3f94ad63315b 67938-1079 HUMAN OTC DRUG Intervene Makeup Broad Spectrum Sunscreen SPF 15 Soft Cameo OCTINOXATE CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 g/30g E 20171231 67938-1080_865912e4-c63e-46e7-9fd7-63b2bc076108 67938-1080 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Beige Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-1081_a970399e-5c2d-4949-9f4b-699dc69fa61c 67938-1081 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Bisque Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-1082_87348e8c-b0bf-4f0a-a6b6-9b699b60ce10 67938-1082 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Wheat Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-1083_bbf219d2-42b9-4113-85f5-ce304a4eb179 67938-1083 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Honey Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-1084_dd22002f-b58b-4b4b-a195-6d566fc8906c 67938-1084 HUMAN OTC DRUG Intervene Makeup Broad Spectrum Sunscreen SPF 15 Soft Cognac OCTINOXATE CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 g/30g E 20171231 67938-1085_038ec972-f4b2-4f5f-a1a7-6764b7a45dad 67938-1085 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Toast Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-1086_6267433f-0a70-482b-9079-b8aa2b0d4a1a 67938-1086 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Bronze Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-1087_48ca5384-182b-4a9b-989d-689ed9666591 67938-1087 HUMAN OTC DRUG Intervene Makeup Broad Spectrum Sunscreen SPF 15 Soft Tan OCTINOXATE CREAM TOPICAL 20101206 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 g/30g E 20171231 67938-1088_e5a7e429-a4c6-4bfa-88fb-d2346d42cfe9 67938-1088 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Toffee Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-1089_2e8d0219-cbcf-4837-a8cb-34ae7b525c7c 67938-1089 HUMAN OTC DRUG Intervene Makeup SPF 15 Soft Cocoa Octinoxate CREAM TOPICAL 20101206 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE 1.5 mL/30mL E 20171231 67938-1094_3b8062cc-06a4-496e-8aa5-8fe2a940014d 67938-1094 HUMAN OTC DRUG Eight Hour Cream Sun Defense for Face SPF 50 Sunscreen Zinc Oxide LOTION TOPICAL 20101214 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc ZINC OXIDE; OCTINOXATE; OCTISALATE 6.159; 3.922; 2.65 g/53g; g/53g; g/53g E 20171231 67938-110_aae738b0-8868-4a6a-89b9-01fbb4e7160a 67938-110 HUMAN OTC DRUG Pure Finish Mineral Tinted Moisturizer SPF 15 Octinoxate LOTION TOPICAL 20100726 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 3; 2.15; 2 mL/50mL; mL/50mL; mL/50mL E 20171231 67938-1111_97dab94c-6a46-48c9-9427-68be6eb6e103 67938-1111 HUMAN OTC DRUG Eight Hour Cream Nourishing Lip Balm SPF 20 OCTINOXATE and AVOBENZONE SALVE TOPICAL 20120724 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; AVOBENZONE .568; .426 g/14.2g; g/14.2g N 20181231 67938-1126_b9134ec2-2e8d-4685-b162-20ede195bf0a 67938-1126 HUMAN OTC DRUG Prevage Anti Aging Eye Sunscreen SPF 15 OCTINOXATE and OXYBENZONE CREAM TOPICAL 20110314 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OXYBENZONE .613; .21 g/15g; g/15g N 20181231 67938-1130_fa51c66b-22fb-44cc-8a99-b4178c023739 67938-1130 HUMAN OTC DRUG Eight Hour Cream Targeted Sun Defense SPF 50 Homosalate STICK TOPICAL 20100712 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE .51; .51; .34; .27; .14 g/6.8g; g/6.8g; g/6.8g; g/6.8g; g/6.8g N 20181231 67938-1145_565e6022-cfef-4384-b96c-b5269ae5e711 67938-1145 HUMAN OTC DRUG Ceramide Premier Intense Moisture and Renewal Activation Broad Spectrum SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, and AVOBENZONE CREAM TOPICAL 20111222 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 3.68; 2.45; 1.96; 1.47; .98 g/49g; g/49g; g/49g; g/49g; g/49g N 20181231 67938-1149_9f78a938-c8af-460d-ae67-e75a5b1f6ad6 67938-1149 HUMAN OTC DRUG EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE PETROLATUM CREAM TOPICAL 20110707 OTC MONOGRAPH FINAL part347 Elizabeth Arden, Inc PETROLATUM 28.4 g/50g N 20181231 67938-1152_478bdcd5-6ad2-44d1-8fb7-094e573fa951 67938-1152 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Bisque Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1153_03cd0b1d-835d-4de3-b457-36dab5381d99 67938-1153 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Camellia Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1154_cf5cf4bd-7b5b-4a5e-a346-6d08164fc4bc 67938-1154 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Sunbeige Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1156_cd07f964-259f-490f-a993-fe57e141a701 67938-1156 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Golden Beige Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1157_006ab296-53b0-495a-aa52-f572728485f3 67938-1157 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Vanilla Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1158_937ecbc9-200a-4887-add5-070aa6dcaf6b 67938-1158 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Cream Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1159_81d5086a-8be0-4aa8-8354-e44c2dd79d1b 67938-1159 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Cameo Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1161_2c3a1f37-5d50-43be-8728-9b36ffa62586 67938-1161 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Buff Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1162_25618c97-46ef-4ddb-91e8-05b83b93e8fd 67938-1162 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Honey Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1163_6e35f920-aefe-4cad-b3b8-6cd3d149b7e6 67938-1163 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Shell Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1164_22f4f6ec-ffe3-4c2a-95df-637bbea2da39 67938-1164 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Beige Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1165_fd591eb9-d3d3-4991-a826-4f813d841bbd 67938-1165 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Mocha Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1169_9730a816-2019-4dd9-90c2-9fe8320017fd 67938-1169 HUMAN OTC DRUG Visible Difference Gentle Hydrating Broad Spectrum Sunscreen SPF 15 OCTINOXATE, AVOBENZONE, and OXYBENZONE CREAM TOPICAL 20111115 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; AVOBENZONE; OXYBENZONE 3.75; 1.5; 1.5 g/50g; g/50g; g/50g N 20181231 67938-1171_1a853083-a2fd-4f41-9413-4256950634a7 67938-1171 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Ivory Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1172_b1125143-4906-4c0b-a662-9d781d7ca1f4 67938-1172 HUMAN OTC DRUG Flawless Finish Dual Perfection Makeup SPF 8 Fawn Titanium Dioxide POWDER TOPICAL 20060524 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE; OCTINOXATE 1.19; .59 g/17g; g/17g E 20171231 67938-1390_ad45ffb5-5db6-4712-856a-8b2d9b495d67 67938-1390 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 1 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g N 20181231 67938-1391_6acb79d2-f096-453f-a3b2-a865d660a369 67938-1391 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 2 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g N 20181231 67938-1392_cc1b63a0-262e-44d1-a8c1-d2592790e516 67938-1392 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 3 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g N 20181231 67938-1393_74268960-ce35-405b-954a-838c0a7367f7 67938-1393 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 4 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g N 20181231 67938-1394_fd135a20-8a9a-4a60-a6d7-36b3dd77cc61 67938-1394 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 5 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g N 20181231 67938-1395_df3caf7c-01d4-4fcb-b1db-ea0bbd365d12 67938-1395 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 6 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g N 20181231 67938-1396_b7c0e970-ad29-4b0e-b840-061fd7ca93f2 67938-1396 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 7 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g N 20181231 67938-1397_9a5fb2ce-fe10-4f20-b62f-4f3869bafb09 67938-1397 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 8 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g N 20181231 67938-1401_8f1f6012-7e09-4f2d-84b4-1f331a77d829 67938-1401 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 9 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g N 20181231 67938-1407_3cc368d7-5027-41f3-a078-fcd9e874edf5 67938-1407 HUMAN OTC DRUG Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Honey Petrolatum STICK TOPICAL 20060328 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc PETROLATUM; PADIMATE O; OXYBENZONE 1.117; .296; .111 g/3.7g; g/3.7g; g/3.7g N 20181231 67938-1408_c1dc4abb-217c-4c63-9e38-02b17d42e199 67938-1408 HUMAN OTC DRUG Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Blush Petrolatum STICK TOPICAL 20060328 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc PETROLATUM; PADIMATE O; OXYBENZONE 1.117; .296; .111 g/3.7g; g/3.7g; g/3.7g N 20181231 67938-1409_89ab540c-b3f0-4771-bf9c-613f9aa2e3e0 67938-1409 HUMAN OTC DRUG Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Plum Petrolatum STICK TOPICAL 20060328 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc PETROLATUM; PADIMATE O; OXYBENZONE 1.117; .296; .111 g/3.7g; g/3.7g; g/3.7g N 20181231 67938-1410_b091c953-431d-42d4-a4dd-5c3144705d1f 67938-1410 HUMAN OTC DRUG Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Chestnut Petrolatum STICK TOPICAL 20060328 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc PETROLATUM; PADIMATE O; OXYBENZONE 1.117; .296; .111 g/3.7g; g/3.7g; g/3.7g E 20171231 67938-1435_b14135f7-f575-4d2b-a719-7875c5f0b6a5 67938-1435 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 10 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g N 20181231 67938-1436_79fa635c-aef0-4e57-84a3-529287035a1e 67938-1436 HUMAN OTC DRUG Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 11 Titanium Dioxide POWDER TOPICAL 20100920 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc TITANIUM DIOXIDE .358 g/8.33g N 20181231 67938-1470_e3a8a087-3248-4c3b-9c0c-e92958888a70 67938-1470 HUMAN OTC DRUG Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Melon Petrolatum STICK TOPICAL 20060328 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc PETROLATUM; PADIMATE O; OXYBENZONE 1.117; .296; .111 g/3.7g; g/3.7g; g/3.7g E 20171231 67938-1472_54448ac9-5df9-4b54-8ca9-edb8123f39b5 67938-1472 HUMAN OTC DRUG Eight Hour Cream Lip Protectant Sheer Tint SPF 15 Berry Petrolatum STICK TOPICAL 20060328 OTC MONOGRAPH FINAL part352 Elizabeth Arden, Inc PETROLATUM; PADIMATE O; OXYBENZONE 1.117; .296; .111 g/3.7g; g/3.7g; g/3.7g N 20181231 67938-2001_6c9bc32a-a84d-4cfb-b56a-80977727a280 67938-2001 HUMAN OTC DRUG EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER DIMETHICONE CREAM TOPICAL 20130507 OTC MONOGRAPH NOT FINAL part310.545 Elizabeth Arden, Inc DIMETHICONE .9 g/45g N 20181231 67938-2002_ba106598-24ea-4b9e-b6c4-24aeaf7d6ee0 67938-2002 HUMAN OTC DRUG VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 1 OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; OXYBENZONE 2.55; 1.95; 1.7; 1.02 g/34g; g/34g; g/34g; g/34g E 20171231 67938-2003_2d6c77af-2d61-4834-9af5-6264d44be206 67938-2003 HUMAN OTC DRUG VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; OXYBENZONE 2.55; 1.95; 1.7; 1.02 g/34g; g/34g; g/34g; g/34g E 20171231 67938-2004_2db8ac12-cc7c-4067-9163-f1254e98cd27 67938-2004 HUMAN OTC DRUG VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 3 OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; OXYBENZONE 2.55; 1.95; 1.7; 1.02 g/34g; g/34g; g/34g; g/34g E 20171231 67938-2005_7fd98d21-94a0-44c2-8101-cd461bbfc17f 67938-2005 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE LINEN OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2006_49970f06-2837-4c4b-80bd-7a2d8addbba4 67938-2006 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE ALABASTER OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2007_bc30d9f9-6245-4009-b2db-8836023e37d1 67938-2007 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE VANILLA SHELL OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2008_8651bf8a-0bbe-4f8d-8527-d03aeef79fc6 67938-2008 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE CREAM NUDE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2009_b9daf843-0207-496b-bdf7-5695b4499540 67938-2009 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE NATURAL OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2010_fd9481eb-edc6-4a04-a158-f2bfa55c7e11 67938-2010 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE WARM SUNBEIGE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2011_0d66d8a1-541c-4603-ab1d-823f476c146c 67938-2011 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE GOLDEN NUDE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2012_21c853af-7632-4b29-9e74-42319ef654e9 67938-2012 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE CASHMERE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2013_bc2a6fbc-6eca-4686-ac82-7cc3ef662668 67938-2013 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE BUFF OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2014_679d8f20-eeee-4d99-9348-e6c3f755f324 67938-2014 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE TAWNY OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2015_62c6c703-963c-4097-926f-8cf33f8e9c12 67938-2015 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE SOFT BEIGE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2016_499a88f2-e4e4-4659-9042-a89f1a4e4e64 67938-2016 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE AMBER OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2017_a940e6a5-1cff-46b0-a4e4-eb166504c9c4 67938-2017 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE BEIGE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2018_f7749993-a38b-416b-9ffb-c917a50d0913 67938-2018 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE CAMEO OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2019_6a5672ce-62d0-45fa-8873-3388baea7a31 67938-2019 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE HONEY BEIGE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2020_eb36f46a-c975-459b-bc0e-6a58c64ea57d 67938-2020 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE TOASTED ALMOND OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2021_f257c3a2-4655-47b9-8b8b-6abf9d791b9d 67938-2021 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE BISQUE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2022_4013b575-afaa-4d26-a0e4-99ff1ab2e82c 67938-2022 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE CASHEW OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2023_07257470-7587-4bbd-af8a-abaf55c0e7c7 67938-2023 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE TOASTY BEIGE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2024_f6474248-5de3-4bb2-b392-dd8baa35f0fe 67938-2024 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE CARAMEL OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2025_8396b4ad-385b-4575-ae91-7428bafe9ba1 67938-2025 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE WARM CAPPUCCINO OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2026_479c5a0d-d029-44e7-9471-2172d05ddb02 67938-2026 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE WARM MAHOGANY OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2027_cedfd055-e137-478d-a327-5287dc10deaa 67938-2027 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE COCOA OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2028_23abfe4c-ee4e-4eea-bbf4-08f5a44ff586 67938-2028 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE SIENNA OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2029_6eace8fc-bad3-4b6c-89fc-843bf1e8fd7e 67938-2029 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE SPICE OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2030_30243138-e310-4ab0-bdbb-3175a67e0857 67938-2030 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY NUDE MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 SHADE CHESTNUT OCTINOXATE and TITANIUM DIOXIDE LOTION TOPICAL 20130717 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; TITANIUM DIOXIDE 60; 18.9 mg/1500mg; mg/1500mg N 20181231 67938-2050_bd1f6a62-b6e3-45df-a94a-718c927b25db 67938-2050 HUMAN OTC DRUG FLAWLESS FUTURE MOISTURE OCTINOXATE, OCTISALATE, OXYBENZONE AND AVOBENZONE CREAM TOPICAL 20141107 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; OCTISALATE; OXYBENZONE; AVOBENZONE 3.57; 2.375; 2; 1.5 g/g; g/g; g/g; g/g N 20181231 67938-2051_1b919bf5-c0b2-4cf8-8c2c-569ce131a8a7 67938-2051 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE ALABASTER OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2052_ba00e9f2-326e-4654-9de1-df40cea55754 67938-2052 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE NUDE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2053_d83543cf-4289-462c-b07b-123e5dd1fb8c 67938-2053 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE CAMEO OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2054_ac4d65a7-9710-4a0b-821b-77bb5d0f5f79 67938-2054 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE HONEY BEIGE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2055_c8eca969-8246-40c4-9894-8ef7283e6b01 67938-2055 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE BISQUE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2056_590ed492-2333-45e1-8f60-1df4350454d7 67938-2056 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE TOASTY BEIGE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2057_5a071dbc-44af-48e8-988c-c0c11adaafc8 67938-2057 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE CARAMEL OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2058_54e42258-e2d0-4907-9b9c-e91b1d64ff03 67938-2058 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE COCOA OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2059_ce23793b-9d78-472b-bd07-7bd4530b149b 67938-2059 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE SPICE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2060_d1117485-5774-4317-868c-fbd381be22a1 67938-2060 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE CHESTNUT OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2061_090c039e-0021-4915-8e1f-a0f52b5995b1 67938-2061 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE SOFT SHELL OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2062_5f9ec300-f85f-42d5-9760-154e7881f980 67938-2062 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE SUNBEIGE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2063_64338ee4-9202-4f40-9406-eb3a5bff8dfc 67938-2063 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2064_c3a66384-e6f5-4508-8761-24ce3f0bf5a8 67938-2064 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE SAND OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2065_b4bb5d6d-2461-4b9b-b136-b51c60db8fa6 67938-2065 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE BEIGE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2066_169bc4f9-cc75-4d7c-8948-9bbd2a6f9080 67938-2066 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE SOFT TAN OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2067_6c49274a-7050-4ca2-a7e0-d4335db088a5 67938-2067 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE NEUTRAL BISQUE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2068_5a6c8bb2-7c06-4cbd-8767-493577d5b6d8 67938-2068 HUMAN OTC DRUG FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE GOLDEN SANDS OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150105 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.725; 1.346 g/mL; g/mL N 20181231 67938-2069_aff2f57b-f332-4b20-b676-6b97abf50c8a 67938-2069 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 GENTLE BEIGE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-2070_95936d43-f88a-46b6-9e78-83d2d488da65 67938-2070 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 JAVA OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-2071_fc96e9d7-0adf-444a-9375-1a24aad98ea0 67938-2071 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 PERFECT BEIGE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-2072_c6bf9f10-c1e4-41c0-a8cf-6ada2f3ee2d4 67938-2072 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 TOASTY BEIGE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-2073_41c19b1c-6c72-43ec-9010-acc16c4e3ebe 67938-2073 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 TRUE BEIGE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-2074_e70f7796-89e6-45cd-8232-5f0175ba4d6f 67938-2074 HUMAN OTC DRUG CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 WARM BISQUE OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150624 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE 1.28; .96 g/32g; g/32g N 20181231 67938-2075_9f92c5e4-8317-4a87-a581-8f81204b5e28 67938-2075 HUMAN OTC DRUG PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC TITANIUM DIOXIDE; ZINC OXIDE .25803; .31416 g/mL; g/mL N 20181231 67938-2076_f3a05263-83a8-42c9-b7d9-cf12e8bbc40f 67938-2076 HUMAN OTC DRUG PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN OCTINOXATE, OXYBENZONE, OCTISALATE, OCTOCRYLENE, AVOBENZONE LOTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE; AVOBENZONE .07575; .06; .0505; .0525; .03237 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 67938-2077_532e7aba-5f4c-4c32-b58b-ecfb51837c19 67938-2077 HUMAN OTC DRUG PRO PERFECTING MINERALS BROAD SPECTRUM SPF 25 SUNSCREEN - SHADE 1 ZINC OXIDE LOTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC ZINC OXIDE 1 g/5g N 20181231 67938-2078_623518ae-cdc6-4efc-b3a6-983e16a7466b 67938-2078 HUMAN OTC DRUG PRO PERFECTING MINERALS BROAD SPECTRUM SPF 25 SUNSCREEN - SHADE 2 ZINC OXIDE LOTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC ZINC OXIDE 1 g/5g N 20181231 67938-2079_921d2ba6-1cf9-42d9-8492-4ae25c8ca23f 67938-2079 HUMAN OTC DRUG PRO PERFECTING MINERALS BROAD SPECTRUM SPF 25 SUNSCREEN - SHADE 3 ZINC OXIDE LOTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC ZINC OXIDE 1 g/5g N 20181231 67938-2080_556b10b6-b7d1-4b3b-b6b1-029f63138c40 67938-2080 HUMAN OTC DRUG PRO PERFECTING MINERALS BROAD SPECTRUM SPF 25 SUNSCREEN - SHADE 4 ZINC OXIDE LOTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC ZINC OXIDE 1 g/5g N 20181231 67938-2081_95ac57f7-efd7-421a-b3a2-18cce03561d4 67938-2081 HUMAN OTC DRUG PRO PERFECTING MINERALS BROAD SPECTRUM SPF 25 SUNSCREEN - SHADE 3 ZINC OXIDE LOTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC ZINC OXIDE 1 g/5g N 20181231 67938-2082_72759961-d435-4b83-9316-c463d6044f45 67938-2082 HUMAN OTC DRUG PRO TRIPLE PROTECTION FACTOR LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN OCTINOXATE, OCTISALATE, AVOBENZONE, ZINC OXIDE LOTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; OCTISALATE; AVOBENZONE; ZINC OXIDE 1.065; .71; .426; .142 g/14.2g; g/14.2g; g/14.2g; g/14.2g N 20181231 67938-3050_4ddbb2b5-162a-4463-a7bd-9a71991ce1bb 67938-3050 HUMAN OTC DRUG ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC TITANIUM DIOXIDE; ZINC OXIDE .062; .056 g/mL; g/mL N 20181231 67938-3051_03adbd91-6e02-4eda-b1fc-5b7e7c444f5a 67938-3051 HUMAN OTC DRUG ELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 30 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 ELIZABETH ARDEN, INC OCTINOXATE; TITANIUM DIOXIDE .06; .06 g/mL; g/mL N 20181231 67938-3052_f2becf1b-e62b-4825-918d-b0719a16f6f0 67938-3052 HUMAN OTC DRUG ELIZABETH ARDEN EIGHT HOUR LIP PROTECTANT PETROLATUM GEL TOPICAL 20170801 OTC MONOGRAPH FINAL part352 ELIZABETH ARDEN, INC PETROLATUM 1 g/85g N 20181231 67938-9144_4a35d8eb-5ba6-4e63-a407-1522330489c3 67938-9144 HUMAN OTC DRUG Prevage Anti Aging Moisture Broad Spectrum Sunscreen SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, and AVOBENZONE CREAM TOPICAL 20110622 OTC MONOGRAPH NOT FINAL part352 Elizabeth Arden, Inc OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 3.75; 2.5; 2.5; 1.1; 1 g/50g; g/50g; g/50g; g/50g; g/50g N 20181231 67939-010_dba4ba64-d5fc-4fb1-9948-c810ff67e4f5 67939-010 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20131101 ANDA ANDA204498 The University of Utah DBA Cyclotron Radiochemistry Lab / Huntsman Cancer Institute FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 67939-020_960f3dc1-d331-4b7f-a213-1c78554d45b2 67939-020 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 Sodium Fluoride F 18 INJECTION INTRAVENOUS 20120711 ANDA ANDA204497 The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 67942-2100_41f2c0d1-4184-4df8-873d-030957094e33 67942-2100 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030430 UNAPPROVED MEDICAL GAS VNA Homecare Services OXYGEN 99 L/100L E 20171231 67979-001_9abaf43d-1a9e-48d2-ba55-22765a2f9082 67979-001 HUMAN PRESCRIPTION DRUG Valstar valrubicin SOLUTION, CONCENTRATE INTRAVESICAL 19981001 NDA NDA020892 Endo Pharmaceuticals Solutions Inc. VALRUBICIN 40 mg/mL N 20181231 67979-002_a36494b9-21f8-4906-b651-954ababc7055 67979-002 HUMAN PRESCRIPTION DRUG SUPPRELIN LA histrelin acetate IMPLANT SUBCUTANEOUS 20070531 NDA NDA022058 Endo Pharmaceuticals Solutions Inc. HISTRELIN ACETATE 50 mg/1 Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] N 20181231 67979-500_1c1df52d-01a3-4b15-a47c-97ac7a524331 67979-500 HUMAN PRESCRIPTION DRUG Vantas histrelin acetate IMPLANT SUBCUTANEOUS 20041101 NDA NDA021732 Endo Pharmaceuticals Solutions Inc. HISTRELIN ACETATE 50 mg/1 Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] N 20181231 67979-511_a3de464c-810a-41c0-9ec6-a8965fee7b80 67979-511 HUMAN PRESCRIPTION DRUG Aveed testosterone undecanoate INJECTION INTRAMUSCULAR 20140305 NDA NDA022219 Endo Pharmaceuticals Solutions Inc. TESTOSTERONE UNDECANOATE 250 mg/mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20191231 67989-011_54e8282d-592d-4a21-ab01-2da34170792e 67989-011 HUMAN PRESCRIPTION DRUG Nitric Oxide Nitrogen Mix Nitric Oxide Nitrogen Mix GAS RESPIRATORY (INHALATION) 20100501 UNAPPROVED MEDICAL GAS Airgas Specialty Gases NITRIC OXIDE; NITROGEN 5; 955 mL/L; mL/L Vasodilation [PE],Vasodilator [EPC] E 20171231 67996-575_cc07d2bb-998d-44c0-beb7-40b6b5d2bbde 67996-575 HUMAN OTC DRUG Kontakt Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20180103 OTC MONOGRAPH NOT FINAL part333E Select Specialty Products BENZETHONIUM CHLORIDE 2 mg/mL N 20191231 67996-876_2a6c1896-679f-4bcd-8a76-30d1a8b7841a 67996-876 HUMAN OTC DRUG Inhibit II High Foaming Antiseptic Hand Cleaner CHLOROXYLENOL SOAP TOPICAL 20170112 OTC MONOGRAPH NOT FINAL part333E Select Specialty Products CHLOROXYLENOL 3 mg/mL N 20181231 67996-938_3ea77080-e488-41ab-8829-92e8e1e089eb 67996-938 HUMAN OTC DRUG Sani-Soft ALCOHOL LOTION TOPICAL 20110301 OTC MONOGRAPH NOT FINAL part333E Select Specialty Products ALCOHOL .7 mL/mL E 20171231 68001-001_d118d1fb-78fa-44d1-aeda-d44bae5e045b 68001-001 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20130320 NDA NDA020064 BluePoint Laboratories NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 68001-002_cfdd8c29-df5c-4866-9fbd-cb6942f869b8 68001-002 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20130320 NDA NDA016620 BluePoint Laboratories NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 68001-003_cfdd8c29-df5c-4866-9fbd-cb6942f869b8 68001-003 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20130320 NDA NDA016620 BluePoint Laboratories NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 68001-004_909f4d77-b980-4126-ab1a-6b06880619f8 68001-004 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20140422 ANDA ANDA203399 BluePoint Laboratories METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 68001-005_c40167c9-6a85-431b-8c04-835b97ec5177 68001-005 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20130802 ANDA ANDA040189 BluePoint Laboratories METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68001-006_5e93a15d-00da-46c2-a7de-84d1ba3aeae8 68001-006 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20130724 ANDA ANDA078926 BluePoint Laboratories GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68001-007_5e93a15d-00da-46c2-a7de-84d1ba3aeae8 68001-007 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20130724 ANDA ANDA078926 BluePoint Laboratories GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68001-105_a532a362-b4b2-4488-9709-448050a22f04 68001-105 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131008 ANDA ANDA078239 BluePoint Laboratories DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68001-106_a532a362-b4b2-4488-9709-448050a22f04 68001-106 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131008 ANDA ANDA078239 BluePoint Laboratories DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68001-111_b3168e9c-493e-406b-b0ce-94043b813a68 68001-111 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20131201 ANDA ANDA091269 BluePoint Laboratories LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68001-112_b3168e9c-493e-406b-b0ce-94043b813a68 68001-112 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20131201 ANDA ANDA091269 BluePoint Laboratories LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68001-113_d8d60513-9ec6-4168-92e4-245cb6f10080 68001-113 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20140213 ANDA ANDA091399 BluePoint Laboratories LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 68001-114_d8d60513-9ec6-4168-92e4-245cb6f10080 68001-114 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20140213 ANDA ANDA091399 BluePoint Laboratories LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 68001-115_292562dc-c684-48a6-ab0c-fc1f56a96755 68001-115 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140224 ANDA ANDA090025 BluePoint Laboratories LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68001-116_292562dc-c684-48a6-ab0c-fc1f56a96755 68001-116 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140224 ANDA ANDA078154 BluePoint Laboratories LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68001-117_292562dc-c684-48a6-ab0c-fc1f56a96755 68001-117 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140224 ANDA ANDA078154 BluePoint Laboratories LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68001-118_292562dc-c684-48a6-ab0c-fc1f56a96755 68001-118 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20140224 ANDA ANDA078154 BluePoint Laboratories LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68001-119_94bea012-2575-418e-aab8-7343b25c1459 68001-119 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20131125 ANDA ANDA078889 BluePoint Laboratories METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-120_94bea012-2575-418e-aab8-7343b25c1459 68001-120 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20131125 ANDA ANDA078889 BluePoint Laboratories METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-121_344ea734-d426-4565-a21c-0705034c7d11 68001-121 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA090617 BluePoint Laboratories METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-122_344ea734-d426-4565-a21c-0705034c7d11 68001-122 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA090617 BluePoint Laboratories METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-129_fba59eef-b311-4224-b85f-f3033627cbf3 68001-129 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20131223 ANDA ANDA090223 BluePoint Laboratories FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68001-130_840e5be9-6e3a-4bd7-8cff-47fd353b8947 68001-130 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20150716 ANDA ANDA078466 BluePoint Laboratories AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68001-131_840e5be9-6e3a-4bd7-8cff-47fd353b8947 68001-131 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20150716 ANDA ANDA078466 BluePoint Laboratories AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68001-132_840e5be9-6e3a-4bd7-8cff-47fd353b8947 68001-132 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20150716 ANDA ANDA078466 BluePoint Laboratories AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68001-133_840e5be9-6e3a-4bd7-8cff-47fd353b8947 68001-133 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20150716 ANDA ANDA078466 BluePoint Laboratories AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68001-134_840e5be9-6e3a-4bd7-8cff-47fd353b8947 68001-134 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20150716 ANDA ANDA078466 BluePoint Laboratories AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68001-135_840e5be9-6e3a-4bd7-8cff-47fd353b8947 68001-135 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20150716 ANDA ANDA078466 BluePoint Laboratories AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68001-136_98d90281-ddf9-4b51-9d16-257043c1fb30 68001-136 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140226 ANDA ANDA077560 BluePoint Laboratories ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 68001-137_98d90281-ddf9-4b51-9d16-257043c1fb30 68001-137 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140226 ANDA ANDA077560 BluePoint Laboratories ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 68001-138_98d90281-ddf9-4b51-9d16-257043c1fb30 68001-138 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140226 ANDA ANDA077560 BluePoint Laboratories ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 68001-139_98d90281-ddf9-4b51-9d16-257043c1fb30 68001-139 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20140226 ANDA ANDA077560 BluePoint Laboratories ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 68001-140_dbad7714-2c93-47e2-890e-0b94a45c44d7 68001-140 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140101 ANDA ANDA078832 BluePoint Laboratories RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-141_dbad7714-2c93-47e2-890e-0b94a45c44d7 68001-141 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140101 ANDA ANDA078832 BluePoint Laboratories RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-142_dbad7714-2c93-47e2-890e-0b94a45c44d7 68001-142 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140101 ANDA ANDA078832 BluePoint Laboratories RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-143_dbad7714-2c93-47e2-890e-0b94a45c44d7 68001-143 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20140101 ANDA ANDA078832 BluePoint Laboratories RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-150_b0d198ac-6b9b-4bc4-99e8-5640be67289a 68001-150 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140207 ANDA ANDA065264 BluePoint Laboratories CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68001-151_2d3b3867-401f-474b-931b-ef25b44cbd85 68001-151 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20140422 ANDA ANDA077614 BluePoint Laboratories CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68001-152_2d3b3867-401f-474b-931b-ef25b44cbd85 68001-152 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20140422 ANDA ANDA077614 BluePoint Laboratories CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68001-153_2d3b3867-401f-474b-931b-ef25b44cbd85 68001-153 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20140422 ANDA ANDA077614 BluePoint Laboratories CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68001-154_2d3b3867-401f-474b-931b-ef25b44cbd85 68001-154 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20140422 ANDA ANDA077614 BluePoint Laboratories CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68001-155_a181594f-ae1d-4da0-86bf-45a4b308aff3 68001-155 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, COATED ORAL 20140101 ANDA ANDA078921 BluePoint Laboratories ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 68001-156_c5bb6b75-598f-4d8e-bf2f-7b7006fe845d 68001-156 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20131125 ANDA ANDA077653 BluePoint Laboratories VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68001-157_c5bb6b75-598f-4d8e-bf2f-7b7006fe845d 68001-157 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20131125 ANDA ANDA077653 BluePoint Laboratories VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68001-158_c5bb6b75-598f-4d8e-bf2f-7b7006fe845d 68001-158 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20131125 ANDA ANDA077653 BluePoint Laboratories VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68001-159_c5bb6b75-598f-4d8e-bf2f-7b7006fe845d 68001-159 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20131125 ANDA ANDA077653 BluePoint Laboratories VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68001-160_c5bb6b75-598f-4d8e-bf2f-7b7006fe845d 68001-160 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20131125 ANDA ANDA077653 BluePoint Laboratories VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68001-161_226a91f4-81c3-4298-bfab-5a2bebaf2ae2 68001-161 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20140113 ANDA ANDA040596 BluePoint Laboratories PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68001-162_226a91f4-81c3-4298-bfab-5a2bebaf2ae2 68001-162 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20140113 ANDA ANDA040596 BluePoint Laboratories PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68001-163_226a91f4-81c3-4298-bfab-5a2bebaf2ae2 68001-163 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20140113 ANDA ANDA040596 BluePoint Laboratories PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68001-171_a87b693c-b466-4bfe-adb6-f127598f72c5 68001-171 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20140122 ANDA ANDA202323 BluePoint Laboratories CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 68001-172_a87b693c-b466-4bfe-adb6-f127598f72c5 68001-172 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20140122 ANDA ANDA202323 BluePoint Laboratories CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 68001-176_c4524c79-e19e-45a8-871e-d03c89aa3daf 68001-176 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET ORAL 20140204 ANDA ANDA202025 BluePoint Laboratories SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 68001-177_31bd9cab-e019-46e0-beaa-2e639ed32757 68001-177 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20140226 ANDA ANDA078181 BluePoint Laboratories GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68001-178_31bd9cab-e019-46e0-beaa-2e639ed32757 68001-178 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20140226 ANDA ANDA078181 BluePoint Laboratories GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68001-179_31bd9cab-e019-46e0-beaa-2e639ed32757 68001-179 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20140226 ANDA ANDA078181 BluePoint Laboratories GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68001-180_0b7dcb39-7d58-4eed-9122-bc9f0d6b04c8 68001-180 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine TABLET ORAL 20130228 ANDA ANDA201109 BluePoint Laboratories QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 68001-181_0b7dcb39-7d58-4eed-9122-bc9f0d6b04c8 68001-181 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine TABLET ORAL 20130228 ANDA ANDA201109 BluePoint Laboratories QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 68001-182_0b7dcb39-7d58-4eed-9122-bc9f0d6b04c8 68001-182 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine TABLET ORAL 20130228 ANDA ANDA201109 BluePoint Laboratories QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 68001-183_0b7dcb39-7d58-4eed-9122-bc9f0d6b04c8 68001-183 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine TABLET ORAL 20130228 ANDA ANDA201109 BluePoint Laboratories QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 68001-184_0b7dcb39-7d58-4eed-9122-bc9f0d6b04c8 68001-184 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine TABLET ORAL 20130228 ANDA ANDA201109 BluePoint Laboratories QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 68001-185_0b7dcb39-7d58-4eed-9122-bc9f0d6b04c8 68001-185 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine TABLET ORAL 20130228 ANDA ANDA201109 BluePoint Laboratories QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 68001-187_8ce1c6a6-d939-4f90-9aad-1fd1d34e8737 68001-187 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140225 ANDA ANDA077690 BluePoint Laboratories QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-188_8ce1c6a6-d939-4f90-9aad-1fd1d34e8737 68001-188 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140225 ANDA ANDA077690 BluePoint Laboratories QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-189_8ce1c6a6-d939-4f90-9aad-1fd1d34e8737 68001-189 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140225 ANDA ANDA077690 BluePoint Laboratories QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-195_e6be3be9-9c3c-4ed9-af95-f2ad2103747a 68001-195 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20140206 ANDA ANDA202280 BluePoint Laboratories ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68001-196_e6be3be9-9c3c-4ed9-af95-f2ad2103747a 68001-196 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20140206 ANDA ANDA202280 BluePoint Laboratories ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68001-197_e6be3be9-9c3c-4ed9-af95-f2ad2103747a 68001-197 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20140206 ANDA ANDA202280 BluePoint Laboratories ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68001-198_e12d3f9a-1914-45cf-b9cd-cf03396cc484 68001-198 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20140207 ANDA ANDA075584 BluePoint Laboratories BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68001-199_e12d3f9a-1914-45cf-b9cd-cf03396cc484 68001-199 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20140207 ANDA ANDA075584 BluePoint Laboratories BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68001-200_964b1f7e-8c60-4c05-8542-c987cee5ca5d 68001-200 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20140224 ANDA ANDA074394 BluePoint Laboratories DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68001-201_964b1f7e-8c60-4c05-8542-c987cee5ca5d 68001-201 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20140224 ANDA ANDA074376 BluePoint Laboratories DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68001-202_964b1f7e-8c60-4c05-8542-c987cee5ca5d 68001-202 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20140224 ANDA ANDA074376 BluePoint Laboratories DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68001-204_fa17f307-3044-45c5-8fef-55841af566f1 68001-204 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20140226 ANDA ANDA075113 BluePoint Laboratories LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-205_fa17f307-3044-45c5-8fef-55841af566f1 68001-205 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20140226 ANDA ANDA075113 BluePoint Laboratories LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-206_fa17f307-3044-45c5-8fef-55841af566f1 68001-206 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20140226 ANDA ANDA075113 BluePoint Laboratories LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-213_c2c901de-c2eb-4c19-bca5-533229411f3c 68001-213 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140210 ANDA ANDA075636 BluePoint Laboratories LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68001-214_c2c901de-c2eb-4c19-bca5-533229411f3c 68001-214 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140210 ANDA ANDA075636 BluePoint Laboratories LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68001-215_37fb70dd-3d5f-4dc0-9cd9-fe1ae9419322 68001-215 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 20140226 ANDA ANDA072011 BluePoint Laboratories TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68001-216_37fb70dd-3d5f-4dc0-9cd9-fe1ae9419322 68001-216 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 20140226 ANDA ANDA073281 BluePoint Laboratories TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68001-219_28f6a109-ba4a-4713-988a-3e453c7446c6 68001-219 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20140205 ANDA ANDA074501 BluePoint Laboratories NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-220_28f6a109-ba4a-4713-988a-3e453c7446c6 68001-220 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20140205 ANDA ANDA074501 BluePoint Laboratories NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-221_28f6a109-ba4a-4713-988a-3e453c7446c6 68001-221 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20140205 ANDA ANDA074501 BluePoint Laboratories NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-222_76f5f486-9708-42d2-86b6-4c4608e96863 68001-222 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20140206 ANDA ANDA089367 BluePoint Laboratories ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68001-223_76f5f486-9708-42d2-86b6-4c4608e96863 68001-223 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20140206 ANDA ANDA086221 BluePoint Laboratories ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68001-224_c2c901de-c2eb-4c19-bca5-533229411f3c 68001-224 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20140210 ANDA ANDA075636 BluePoint Laboratories LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68001-225_76f5f486-9708-42d2-86b6-4c4608e96863 68001-225 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20140206 ANDA ANDA086223 BluePoint Laboratories ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68001-226_e243455a-5c04-4036-99cc-93aa9c891b6b 68001-226 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20140227 ANDA ANDA200826 BluePoint Laboratories URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 68001-227_e243455a-5c04-4036-99cc-93aa9c891b6b 68001-227 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20140227 ANDA ANDA200826 BluePoint Laboratories URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 68001-228_5bc6894e-1063-43bc-8014-dbe464180ed0 68001-228 HUMAN PRESCRIPTION DRUG Trospium Chloride Trospium Chloride CAPSULE, EXTENDED RELEASE ORAL 20140311 ANDA ANDA091289 BluePoint Laboratories TROSPIUM CHLORIDE 60 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68001-229_29c242c6-86ea-643e-e054-00144ff8d46c 68001-229 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20140313 ANDA ANDA070035 BluePoint Laboratories METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68001-231_e39119a6-c5e2-48cb-9210-4fad035b53a7 68001-231 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121101 ANDA ANDA201089 BluePoint Laboratories DICLOFENAC SODIUM; MISOPROSTOL 50; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 68001-232_e39119a6-c5e2-48cb-9210-4fad035b53a7 68001-232 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20121101 ANDA ANDA201089 BluePoint Laboratories DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 68001-233_fd8867bb-e8f2-44e3-8443-d82a38e8a01b 68001-233 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20140227 ANDA ANDA076470 BluePoint Laboratories DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 68001-234_fd8867bb-e8f2-44e3-8443-d82a38e8a01b 68001-234 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20140227 ANDA ANDA076470 BluePoint Laboratories DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 68001-235_2b071a68-c3e6-6c21-e054-00144ff8d46c 68001-235 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20140225 ANDA ANDA076368 BluePoint Laboratories POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68001-236_3013dea9-799e-4741-84f9-45df1320d6d9 68001-236 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140224 ANDA ANDA077715 BluePoint Laboratories BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68001-237_46a5c3f0-50d7-4d43-b320-2c679bba0419 68001-237 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070974 BluePoint Laboratories CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68001-238_46a5c3f0-50d7-4d43-b320-2c679bba0419 68001-238 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070975 BluePoint Laboratories CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68001-239_46a5c3f0-50d7-4d43-b320-2c679bba0419 68001-239 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 19950103 ANDA ANDA070976 BluePoint Laboratories CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68001-240_5ed2af26-028d-477e-9013-0e3c8d23b807 68001-240 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20140407 ANDA ANDA078916 BluePoint Laboratories FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68001-241_5ed2af26-028d-477e-9013-0e3c8d23b807 68001-241 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20140407 ANDA ANDA078916 BluePoint Laboratories FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68001-242_0ce0b804-4309-467b-9eb4-16b28eda70d2 68001-242 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20140313 ANDA ANDA077651 BluePoint Laboratories ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68001-243_0ce0b804-4309-467b-9eb4-16b28eda70d2 68001-243 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20140313 ANDA ANDA077651 BluePoint Laboratories ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68001-244_0ce0b804-4309-467b-9eb4-16b28eda70d2 68001-244 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20140313 ANDA ANDA077651 BluePoint Laboratories ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68001-245_d89d70a4-4c26-4d0d-bba2-02a7f3e55ff2 68001-245 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20140313 ANDA ANDA091211 BluePoint Laboratories ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 68001-246_e2464dba-cbde-4cb3-9f4f-713b1865b322 68001-246 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20140313 ANDA ANDA078152 BluePoint Laboratories ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68001-247_e2464dba-cbde-4cb3-9f4f-713b1865b322 68001-247 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20140313 ANDA ANDA078152 BluePoint Laboratories ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68001-248_7949d4f8-8887-4623-9d27-066251edca17 68001-248 HUMAN PRESCRIPTION DRUG montelukast sodium montelukast sodium TABLET, FILM COATED ORAL 20140313 ANDA ANDA090926 BluePoint Laboratories MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68001-249_3a8ccdb6-f196-4de6-9dac-5357cd0f6743 68001-249 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20140313 ANDA ANDA201779 BluePoint Laboratories ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68001-250_3a8ccdb6-f196-4de6-9dac-5357cd0f6743 68001-250 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20140313 ANDA ANDA201779 BluePoint Laboratories ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68001-251_4ce10e1d-7393-4b40-bfb5-e3114463ff0d 68001-251 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140313 ANDA ANDA077253 BluePoint Laboratories FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68001-252_4ce10e1d-7393-4b40-bfb5-e3114463ff0d 68001-252 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140313 ANDA ANDA077253 BluePoint Laboratories FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68001-253_4ce10e1d-7393-4b40-bfb5-e3114463ff0d 68001-253 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140313 ANDA ANDA077253 BluePoint Laboratories FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68001-254_4ce10e1d-7393-4b40-bfb5-e3114463ff0d 68001-254 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140313 ANDA ANDA077253 BluePoint Laboratories FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68001-255_c5422688-99cc-4445-8a06-710e4423e7ff 68001-255 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140314 ANDA ANDA090739 BluePoint Laboratories DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68001-256_c5422688-99cc-4445-8a06-710e4423e7ff 68001-256 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140314 ANDA ANDA090739 BluePoint Laboratories DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68001-257_c5422688-99cc-4445-8a06-710e4423e7ff 68001-257 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140314 ANDA ANDA090739 BluePoint Laboratories DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68001-259_2ae0ea7c-2812-5f0c-e054-00144ff8d46c 68001-259 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20130623 ANDA ANDA202128 BluePoint Laboratories POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68001-260_8ce1c6a6-d939-4f90-9aad-1fd1d34e8737 68001-260 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140718 ANDA ANDA077690 BluePoint Laboratories QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-261_d740c721-725e-4f06-b07b-7dc423c79fa0 68001-261 HUMAN PRESCRIPTION DRUG bupropion bupropion TABLET, EXTENDED RELEASE ORAL 20150122 ANDA ANDA077285 BluePoint Laboratories BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68001-263_29c242c6-86ea-643e-e054-00144ff8d46c 68001-263 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20140924 ANDA ANDA070044 BluePoint Laboratories METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68001-264_11b02f7e-04f0-4759-bd55-33f8b65fadf2 68001-264 HUMAN PRESCRIPTION DRUG bupropion bupropion TABLET, EXTENDED RELEASE ORAL 20141003 ANDA ANDA201567 BluePoint Laboratories BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68001-265_a9427b53-863a-4c9f-a458-aedbd9455184 68001-265 HUMAN PRESCRIPTION DRUG Etoposide Etoposide INJECTION INTRAVENOUS 20131114 ANDA ANDA074513 BluePoint Laboratories ETOPOSIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 68001-266_7466b5ce-1c30-4a32-8df5-bfcdfb4125b4 68001-266 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20141216 ANDA ANDA040798 BluePoint Laboratories FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 68001-266_c7e082d2-96d6-498c-9827-c42c72719d5c 68001-266 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20141215 ANDA ANDA040743 BluePoint Laboratories FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 68001-267_d7e7dcca-08fe-4cb1-acc0-5ea339286fe2 68001-267 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20161014 ANDA ANDA075994 BluePoint Laboratories LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-268_d7e7dcca-08fe-4cb1-acc0-5ea339286fe2 68001-268 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150706 ANDA ANDA075994 BluePoint Laboratories LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-269_d7e7dcca-08fe-4cb1-acc0-5ea339286fe2 68001-269 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150706 ANDA ANDA075994 BluePoint Laboratories LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-270_d7e7dcca-08fe-4cb1-acc0-5ea339286fe2 68001-270 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150706 ANDA ANDA075994 BluePoint Laboratories LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-271_d7e7dcca-08fe-4cb1-acc0-5ea339286fe2 68001-271 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20140204 ANDA ANDA075994 BluePoint Laboratories LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-272_d7e7dcca-08fe-4cb1-acc0-5ea339286fe2 68001-272 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20160907 ANDA ANDA075994 BluePoint Laboratories LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-279_f52cec4c-a070-44f8-8370-6a7b65bf6828 68001-279 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20151221 ANDA ANDA090066 BluePoint Laboratories DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68001-280_f52cec4c-a070-44f8-8370-6a7b65bf6828 68001-280 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20151221 ANDA ANDA090066 BluePoint Laboratories DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68001-281_f52cec4c-a070-44f8-8370-6a7b65bf6828 68001-281 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20151221 ANDA ANDA077863 BluePoint Laboratories DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68001-282_338134f6-dbe3-215c-e054-00144ff88e88 68001-282 HUMAN PRESCRIPTION DRUG Gemcitabine Hydrochloride Gemcitabine Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA091594 BluePoint Laboratories GEMCITABINE HYDROCHLORIDE 38 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 68001-283_a60c5173-6bc0-4c9d-9674-b3f4d68f79ba 68001-283 HUMAN PRESCRIPTION DRUG Cisplatin Cisplatin INJECTION INTRAVENOUS 20160802 ANDA ANDA206774 BluePoint Laboratories CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 68001-284_008d20d9-4743-4fc4-9570-d4d2f062c6a1 68001-284 HUMAN PRESCRIPTION DRUG Irinotecan Hydrochloride Irinotecan Hydrochloride INJECTION INTRAVENOUS 20080220 ANDA ANDA077219 BluePoint Laboratories IRINOTECAN HYDROCHLORIDE 20 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] N 20181231 68001-285_f73c5c51-46ca-4669-8b7e-f76d964e6696 68001-285 HUMAN PRESCRIPTION DRUG Leucovorin Leucovorin Calcium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160701 ANDA ANDA200753 BluePoint Laboratories LEUCOVORIN CALCIUM 10 mg/mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 68001-286_f73c5c51-46ca-4669-8b7e-f76d964e6696 68001-286 HUMAN PRESCRIPTION DRUG Leucovorin Leucovorin Calcium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160701 ANDA ANDA200855 BluePoint Laboratories LEUCOVORIN CALCIUM 20 mg/mL Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 68001-287_17d9ace6-902d-40f1-abf8-30e0c185a689 68001-287 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070612 ANDA ANDA077284 BluePoint Laboratories BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68001-303_cd6900a5-c9fd-46e1-83bf-2f9d54937fd1 68001-303 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20170314 ANDA ANDA075604 BluePoint Laboratories POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68001-308_e86d0660-3a1a-48f3-b484-27c91ea2aaf9 68001-308 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 BluePoint Laboratories BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68001-309_e86d0660-3a1a-48f3-b484-27c91ea2aaf9 68001-309 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 BluePoint Laboratories BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68001-313_5f0f9ee3-a5b1-4a25-a34c-7f38c8433f4a 68001-313 HUMAN PRESCRIPTION DRUG Azacitidine Azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS; SUBCUTANEOUS 20170701 NDA NDA208216 BluePoint Laboratories AZACITIDINE 100 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 68001-314_71565c11-74c9-4367-9d3c-a4264786a185 68001-314 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 BluePoint Laboratories LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68001-315_71565c11-74c9-4367-9d3c-a4264786a185 68001-315 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 BluePoint Laboratories LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68001-316_71565c11-74c9-4367-9d3c-a4264786a185 68001-316 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 BluePoint Laboratories LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68001-317_0a2acdc0-aab6-462e-a377-67a0f3d55ec6 68001-317 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20160223 ANDA ANDA203455 BluePoint Laboratories NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-318_0a2acdc0-aab6-462e-a377-67a0f3d55ec6 68001-318 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20160223 ANDA ANDA203455 BluePoint Laboratories NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-319_0a2acdc0-aab6-462e-a377-67a0f3d55ec6 68001-319 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20160223 ANDA ANDA203455 BluePoint Laboratories NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68001-321_d0a4db08-8dbd-4c89-b79d-d0a3f691dc96 68001-321 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20170322 ANDA ANDA206556 BluePoint Laboratories BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68001-322_d0a4db08-8dbd-4c89-b79d-d0a3f691dc96 68001-322 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20170322 ANDA ANDA206556 BluePoint Laboratories BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68001-323_d4d42e8d-64e8-4e84-a3cb-e4bb860752d8 68001-323 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170430 ANDA ANDA205883 BluePoint Laboratories MEROPENEM 500 mg/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 68001-324_d4d42e8d-64e8-4e84-a3cb-e4bb860752d8 68001-324 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170430 ANDA ANDA205883 BluePoint Laboratories MEROPENEM 1 g/30mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 68001-325_ec33d692-7432-4197-9807-4137ee2a1d56 68001-325 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20170430 ANDA ANDA201831 BluePoint Laboratories DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 68001-326_ec33d692-7432-4197-9807-4137ee2a1d56 68001-326 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20170430 ANDA ANDA201831 BluePoint Laboratories DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 68001-327_4f44fb73-7f61-4623-ae89-61abd8e945ab 68001-327 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20170430 ANDA ANDA071251 BluePoint Laboratories TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68001-328_4f44fb73-7f61-4623-ae89-61abd8e945ab 68001-328 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20170430 ANDA ANDA071251 BluePoint Laboratories TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68001-329_84e9a534-dce6-4224-b65d-5404176b0103 68001-329 HUMAN PRESCRIPTION DRUG Bloxiverz Neostigmine Methylsulfate INJECTION INTRAVENOUS 20170630 NDA NDA204078 BluePoint Laboratories NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68001-330_83f88215-76d6-40a5-888b-1dcd1eb05c0b 68001-330 HUMAN PRESCRIPTION DRUG Akovaz ephedrine sulfate INJECTION INTRAVENOUS 20170630 NDA NDA208289 BluePoint Laboratories EPHEDRINE SULFATE 50 mg/mL alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE] N 20181231 68001-331_35b03246-570d-4384-921b-bcba8a64255d 68001-331 HUMAN PRESCRIPTION DRUG Vazculep Phenylephrine Hydrochloride INJECTION INTRAVENOUS 20170630 NDA NDA204300 BluePoint Laboratories PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] N 20181231 68001-332_568b49a0-646a-492b-a83a-9117edb81b02 68001-332 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170801 ANDA ANDA077321 BluePoint Laboratories LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-333_568b49a0-646a-492b-a83a-9117edb81b02 68001-333 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170801 ANDA ANDA077321 BluePoint Laboratories LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-334_568b49a0-646a-492b-a83a-9117edb81b02 68001-334 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170801 ANDA ANDA077321 BluePoint Laboratories LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-335_568b49a0-646a-492b-a83a-9117edb81b02 68001-335 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170801 ANDA ANDA077321 BluePoint Laboratories LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-336_568b49a0-646a-492b-a83a-9117edb81b02 68001-336 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170801 ANDA ANDA077321 BluePoint Laboratories LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-337_568b49a0-646a-492b-a83a-9117edb81b02 68001-337 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170801 ANDA ANDA077321 BluePoint Laboratories LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68001-338_ed15e6c9-26c4-4d31-acbd-09a513a188e1 68001-338 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin INJECTION, SOLUTION INTRAVENOUS 20180131 ANDA ANDA205694 BluePoint Laboratories VANCOMYCIN HYDROCHLORIDE 500 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 68001-339_ed15e6c9-26c4-4d31-acbd-09a513a188e1 68001-339 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin INJECTION, SOLUTION INTRAVENOUS 20180131 ANDA ANDA205694 BluePoint Laboratories VANCOMYCIN HYDROCHLORIDE 1 g/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20191231 68007-200_6eb2e368-fe0b-4c3a-9bb0-3603c6646813 68007-200 HUMAN OTC DRUG TIANHE GUBEN YAOSHEN TIE GAO MENTHOL PATCH TRANSDERMAL 20100426 OTC MONOGRAPH NOT FINAL part348 GUILIN TIANHE PHARMACEUTICAL CO LTD MENTHOL 3 g/1 E 20171231 68007-201_e564e77f-d241-4a0b-8a5f-4a49a75a74cf 68007-201 HUMAN OTC DRUG TIANHE GUTONG TIEGAO EXTERNAL ANALGESIC PATCH PATCH TRANSDERMAL 20100524 OTC MONOGRAPH NOT FINAL part348 GUILIN TIANHE PHARMACEUTICAL CO LTD CAMPHOR (NATURAL); CAPSAICIN; MENTHOL 3.5; .25; 3.05 g/1; g/1; g/1 E 20171231 68007-202_fb358e32-8e4d-4041-8cf6-e07425c14706 68007-202 HUMAN OTC DRUG TIANHE GUTONG TIEGAO (IN POLYISOBUTYLENE CARRIER) EXTERNAL ANALGESIC PATCH PATCH TRANSDERMAL 20100524 OTC MONOGRAPH NOT FINAL part348 GUILIN TIANHE PHARMACEUTICAL CO LTD CAMPHOR (NATURAL); CAPSAICIN; MENTHOL 4; .25; 3.05 g/1; g/1; g/1 E 20171231 68007-203_d61ccc5c-3720-4bfe-a92a-259e08939a88 68007-203 HUMAN OTC DRUG TIANHE ZHUANGGU GAO PAIN RELIEVING PLASTER PLASTER TRANSDERMAL 20100525 OTC MONOGRAPH NOT FINAL part348 GUILIN TIANHE PHARMACEUTICAL CO LTD CAMPHOR (NATURAL); MENTHOL; METHYL SALICYLATE 3.22; 1.39; 15.01 g/1; g/1; g/1 E 20171231 68007-204_292712a8-5152-442d-8277-f40923fd935f 68007-204 HUMAN OTC DRUG TIANHE ZHUIFENG GAO CAMPHOR, CAPSAICIN AND MENTHOL PLASTER TRANSDERMAL 20100527 OTC MONOGRAPH NOT FINAL part348 GUILIN TIANHE PHARMACEUTICAL CO LTD CAMPHOR (NATURAL); CAPSAICIN; MENTHOL 4.75; .25; 1.4 g/1; g/1; g/1 E 20171231 68007-300_5a9af542-8b5b-40b2-b31c-f546a185af6b 68007-300 HUMAN OTC DRUG GUTONG TIEGAO PAIN RELIEVING CAMPHOR AND MENTHOL PATCH TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part348 GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD CAMPHOR (SYNTHETIC); MENTHOL 43.9; 18.8 mg/1; mg/1 N 20181231 68007-301_7aec0875-f9ac-4af3-bbce-46be3f545e76 68007-301 HUMAN OTC DRUG GUTONG TIEGAO PAIN RELIEVING Camphor and Menthol PATCH TOPICAL 20160413 OTC MONOGRAPH NOT FINAL part348 GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD CAMPHOR (SYNTHETIC); MENTHOL 248; 100 mg/1; mg/1 N 20181231 68012-002_fb724b2f-b565-4cb8-b185-a0054e971af1 68012-002 HUMAN PRESCRIPTION DRUG Glumetza metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060801 NDA NDA021748 Santarus, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68012-003_fb724b2f-b565-4cb8-b185-a0054e971af1 68012-003 HUMAN PRESCRIPTION DRUG Glumetza metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080617 NDA NDA021748 Santarus, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68012-052_e6b4dec7-c93d-4b31-bb58-8565537061bf 68012-052 HUMAN PRESCRIPTION DRUG ZEGERID omeprazole and sodium bicarbonate POWDER, FOR SUSPENSION ORAL 20040615 NDA NDA021636 Santarus, Inc.. OMEPRAZOLE; SODIUM BICARBONATE 20; 1680 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68012-054_e6b4dec7-c93d-4b31-bb58-8565537061bf 68012-054 HUMAN PRESCRIPTION DRUG ZEGERID omeprazole and sodium bicarbonate POWDER, FOR SUSPENSION ORAL 20140615 NDA NDA021636 Santarus, Inc.. OMEPRAZOLE; SODIUM BICARBONATE 40; 1680 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68012-102_e6b4dec7-c93d-4b31-bb58-8565537061bf 68012-102 HUMAN PRESCRIPTION DRUG ZEGERID omeprazole and sodium bicarbonate CAPSULE ORAL 20060227 NDA NDA021849 Santarus, Inc.. OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68012-104_e6b4dec7-c93d-4b31-bb58-8565537061bf 68012-104 HUMAN PRESCRIPTION DRUG ZEGERID omeprazole and sodium bicarbonate CAPSULE ORAL 20060227 NDA NDA021849 Santarus, Inc.. OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68012-258_3d951799-55d5-4530-b9c9-c7589f28e1a6 68012-258 HUMAN PRESCRIPTION DRUG CYCLOSET bromocriptine mesylate TABLET ORAL 20101115 NDA NDA020866 Santarus, Inc. BROMOCRIPTINE MESYLATE .8 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 68012-309_2c9caa0c-ec04-4872-8ab3-abdc80fa7a65 68012-309 HUMAN PRESCRIPTION DRUG Uceris budesonide TABLET, EXTENDED RELEASE ORAL 20130114 NDA NDA203634 Santarus Inc. BUDESONIDE 9 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68012-350_3c153275-2fb0-4620-89a5-846d3a70ad96 68012-350 HUMAN PRESCRIPTION DRUG Ruconest c1 esterase inhibitor recombinant INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20140922 BLA BLA125495 Santarus, Inc. CONESTAT ALFA 2100 U/1 N 20181231 68012-490_883a4a2b-8c2c-4bb4-b3d3-820179722843 68012-490 HUMAN PRESCRIPTION DRUG Fenoglide fenofibrate TABLET ORAL 20101118 NDA NDA022118 Santarus, Inc. FENOFIBRATE 40 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68012-495_883a4a2b-8c2c-4bb4-b3d3-820179722843 68012-495 HUMAN PRESCRIPTION DRUG Fenoglide fenofibrate TABLET ORAL 20101118 NDA NDA022118 Santarus, Inc. FENOFIBRATE 120 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68016-002_1e79379d-9994-4176-8f9f-ccdee64453ea 68016-002 HUMAN OTC DRUG Stool Softener with Laxative Docusate sodium and Sennosides TABLET ORAL 20100708 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 68016-003_9d848ffc-b9d1-447c-ad28-f225967cc369 68016-003 HUMAN OTC DRUG Premier Value Antibacterial Plus Urinary Pain Relief METHENAMINE, SODIUM SALICYLATE TABLET ORAL 20170222 UNAPPROVED DRUG OTHER Chain Drug Consortium, LLC METHENAMINE; SODIUM SALICYLATE 162; 162.5 mg/1; mg/1 N 20181231 68016-004_31cf4b46-8735-466c-955d-e0348e3abccc 68016-004 HUMAN OTC DRUG Antacid Antigas Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part331 Chain Drug Consortium, LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 68016-005_5c169066-20ad-4b96-88f8-59da57e4684b 68016-005 HUMAN OTC DRUG Premier Value Cavity Protection Mint SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20030908 OTC MONOGRAPH FINAL part355 Premier Value SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 68016-006_beb70f56-4529-4ddd-92bc-777d6b26dfc9 68016-006 HUMAN OTC DRUG Hair Regrowth Treatment for Women Minoxidil SOLUTION TOPICAL 20000101 ANDA ANDA074588 Chain Drug Consortium, LLC MINOXIDIL 2 g/100mL N 20181231 68016-007_2858893f-f080-4752-9433-552dbf7a4cb9 68016-007 HUMAN OTC DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20171016 ANDA ANDA209339 Chain Drug Consortium, LLC ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg/1 N 20181231 68016-008_d93df710-c5c7-4807-bdc2-4cbccb1518b5 68016-008 HUMAN OTC DRUG Premier Value Famotidine Famotidine TABLET, FILM COATED ORAL 20100723 ANDA ANDA090283 Premier Value FAMOTIDINE 20 mg/1 N 20181231 68016-009_e9a89008-8a73-4187-a379-5ff8f42866e2 68016-009 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone OINTMENT TOPICAL 20060908 OTC MONOGRAPH NOT FINAL part348 Chain Drug Consortium, LLC HYDROCORTISONE 1 g/100g N 20181231 68016-010_d93df710-c5c7-4807-bdc2-4cbccb1518b5 68016-010 HUMAN OTC DRUG Premier Value Famotidine Famotidine TABLET, FILM COATED ORAL 20100625 ANDA ANDA090283 Premier Value FAMOTIDINE 10 mg/1 N 20181231 68016-012_766687c8-3394-467a-a95e-31521899a69f 68016-012 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20110421 OTC MONOGRAPH NOT FINAL part333A Chain Drug Consortium, LLC ISOPROPYL ALCOHOL 1.4 mL/1 N 20181231 68016-013_2089e3cb-5fe8-4aec-a5c9-3d0aea4ec941 68016-013 HUMAN OTC DRUG povidine iodine povidine iodine SOLUTION TOPICAL 20110317 OTC MONOGRAPH FINAL part333C Chain Drug Consortium, LLC POVIDONE-IODINE 10 mL/100mL E 20171231 68016-014_4eedcf7f-412d-4d50-b50e-48b9fd4c6a1c 68016-014 HUMAN OTC DRUG PREMIER VALUE TOLNAFTATE ANTIFUNGAL TOLNAFTATE CREAM TOPICAL 20120120 OTC MONOGRAPH FINAL part333C CHAIN DRUG CONSORTIUM, LLC TOLNAFTATE 10 mg/g E 20171231 68016-015_5d906a8a-0656-51d6-e053-2a91aa0a9a61 68016-015 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20120315 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium LLC GLYCERIN 2 g/1 N 20181231 68016-016_6e3917c0-a979-42e2-9ced-f97a2d38836d 68016-016 HUMAN OTC DRUG Peptic Relief Bismuth Subsalicylate SUSPENSION ORAL 20090813 OTC MONOGRAPH FINAL part335 Chain Drug Consortium, LLC BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 68016-018_5e1a7b93-dc36-424e-b8db-d5c2bc84f508 68016-018 HUMAN OTC DRUG Tussin DM COUGH SUPPRESSANT/EXPECTORANT DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20120901 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 68016-018_fc07a008-bcb5-42d8-8c94-39c2e2c6398f 68016-018 HUMAN OTC DRUG Tussin DM Cough suppressant/Expectorant Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20100108 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 68016-019_780caedc-5be7-4f20-b55c-28e788d73149 68016-019 HUMAN OTC DRUG Premier Value Chest Congestion Relief Guaifenesin TABLET ORAL 20090504 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC GUAIFENESIN 400 mg/1 N 20181231 68016-020_4e1b822a-7207-4c59-bb85-ad4db9754b39 68016-020 HUMAN OTC DRUG Tussin EXPECTORANT GUAIFENESIN LIQUID ORAL 20120907 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC GUAIFENESIN 100 mg/5mL N 20181231 68016-021_5ccdc694-5b9e-4e05-b1e6-ec6ac3d5cc20 68016-021 HUMAN OTC DRUG Premier Value Chest and Sinus Congestion relief Guaifenesin/phenylephrine TABLET ORAL 20060201 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 68016-022_af86fbdf-6872-4884-9fd0-1a22c3145476 68016-022 HUMAN OTC DRUG Complete Allergy Medicine Diphenhydramine HCl CAPSULE ORAL 20110323 OTC MONOGRAPH FINAL part336 Chain Drug Consortium, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68016-023_82a61a5f-5cb3-4b5e-b039-345d5fd46478 68016-023 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20080422 ANDA ANDA090182 Chain Drug Consortium, LLC (Premier Value) CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 68016-024_4c12ec14-2713-4acb-bc86-bc03143ca3a8 68016-024 HUMAN OTC DRUG Peptic Relief Maximum Strength BISMUTH SUBSALICYLATE SUSPENSION ORAL 20090708 OTC MONOGRAPH FINAL part335 Chain Drug Consortium, LLC BISMUTH SUBSALICYLATE 525 mg/15mL N 20181231 68016-026_1e92cbc2-8ec7-442e-a6ec-d069080c53fd 68016-026 HUMAN OTC DRUG Adult Long Lasting-Cough Relief Dextromethorphan HBr,USP CAPSULE ORAL 20130522 OTC MONOGRAPH FINAL part341 Chain Drug Consortium LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 68016-027_336b9ad8-cb28-4648-afad-2a8f6da923d0 68016-027 HUMAN OTC DRUG Vitamin A D Petrolatum OINTMENT TOPICAL 20100511 OTC MONOGRAPH FINAL part347 Chain Drug Consortium, LLC PETROLATUM .76 g/g E 20171231 68016-029_05e11584-1877-0207-e054-00144ff88e88 68016-029 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET, COATED ORAL 20070901 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN 500 mg/1 N 20181231 68016-030_17331594-e332-4ada-9b6b-3805d92f0e98 68016-030 HUMAN OTC DRUG Ibuprofen Pain reliever/ Fever Reducer Ibuprofen 200 mg TABLET ORAL 20141230 ANDA ANDA019355 Chain Drug Consortium IBUPROFEN 200 mg/1 E 20171231 68016-031_42eef3a2-c473-56c3-e054-00144ff8d46c 68016-031 HUMAN OTC DRUG Menthol cough drop Menthol LOZENGE ORAL 20150630 OTC MONOGRAPH FINAL part341 Premier Value MENTHOL 5.4 mg/1 N 20181231 68016-032_4316df6e-3aea-4ab5-e054-00144ff88e88 68016-032 HUMAN OTC DRUG menthol cough drop cherry LOZENGE ORAL 20150630 OTC MONOGRAPH FINAL part341 Premier Value MENTHOL 5.8 mg/1 N 20181231 68016-032_43267299-6efd-2783-e054-00144ff8d46c 68016-032 HUMAN OTC DRUG menthol cough drop Cherry LOZENGE ORAL 20150630 OTC MONOGRAPH FINAL part341 Premier Value MENTHOL 5.8 mg/1 N 20181231 68016-033_433b4012-3d13-279e-e054-00144ff8d46c 68016-033 HUMAN OTC DRUG Menthol cough drop Honey Lemon LOZENGE ORAL 20150630 OTC MONOGRAPH FINAL part341 Premier Value MENTHOL 7.5 mg/1 N 20181231 68016-033_43cc254b-6631-63dd-e054-00144ff88e88 68016-033 HUMAN OTC DRUG Menthol cough drop Honey Lemon LOZENGE ORAL 20150630 OTC MONOGRAPH FINAL part341 Premier Value MENTHOL 7.5 mg/1 N 20181231 68016-034_43ccabb9-3442-18c3-e054-00144ff8d46c 68016-034 HUMAN OTC DRUG Menthol cough drop SF Menthol LOZENGE ORAL 20150630 OTC MONOGRAPH FINAL part341 Premier Value MENTHOL 5.8 mg/1 N 20181231 68016-035_c48c2039-a5ae-4368-a309-076774acaea3 68016-035 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20030911 OTC MONOGRAPH FINAL part333C Chain Drug Consortium, LLC CLOTRIMAZOLE 10 mg/g N 20181231 68016-036_444054ad-9b9d-2b08-e054-00144ff8d46c 68016-036 HUMAN OTC DRUG menthol cough drop SF Cherry LOZENGE ORAL 20150630 OTC MONOGRAPH FINAL part341 Premier Value MENTHOL 5.8 mg/1 N 20181231 68016-037_45606762-d97c-45c1-e054-00144ff8d46c 68016-037 HUMAN OTC DRUG SF menthol cough drop Honey Lemon LOZENGE ORAL 20150630 OTC MONOGRAPH FINAL part341 Premier Value MENTHOL 7.6 mg/1 N 20181231 68016-038_464e48da-0aeb-54be-e054-00144ff88e88 68016-038 HUMAN OTC DRUG Sore throat and cough lozenge Mixed Berry LOZENGE ORAL 20150728 OTC MONOGRAPH NOT FINAL part356 Premier Value DEXTROMETHORPHAN HYDROBROMIDE; BENZOCAINE 5; 7.5 mg/1; mg/1 N 20181231 68016-039_466548dc-c971-29bf-e054-00144ff88e88 68016-039 HUMAN OTC DRUG antacid soft chew cherry TABLET, CHEWABLE ORAL 20150702 OTC MONOGRAPH FINAL part331 Premier Value CALCIUM CARBONATE 1177 mg/1 N 20181231 68016-040_4e8ca92e-bfd6-65cf-e054-00144ff8d46c 68016-040 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20170425 OTC MONOGRAPH FINAL part341 Chain Drug Consortium MENTHOL 7.5 mg/1 N 20181231 68016-041_5b3542a3-7ea1-a5ee-e053-2991aa0aa1c3 68016-041 HUMAN OTC DRUG menthol cough drops Menthol LOZENGE ORAL 20171010 OTC MONOGRAPH FINAL part341 Chain Drug Consortium MENTHOL 5.4 mg/1 N 20191231 68016-041_6400848f-ec3d-634d-e053-2991aa0ad302 68016-041 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20180130 OTC MONOGRAPH FINAL part341 Chain Drug Consortium MENTHOL 5.4 mg/1 N 20191231 68016-042_5b365d90-64ec-9fd3-e053-2a91aa0adb2e 68016-042 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20171010 OTC MONOGRAPH FINAL part341 Chain Drug Consortium MENTHOL 5.8 mg/1 N 20191231 68016-042_64013c34-a96c-06c5-e053-2a91aa0a19e5 68016-042 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20180130 OTC MONOGRAPH FINAL part341 Chain Drug Consortium MENTHOL 5.8 mg/1 N 20191231 68016-043_5b3786e0-8b6b-421c-e053-2991aa0a5ab1 68016-043 HUMAN OTC DRUG honey lemon cough drop Menthol LOZENGE ORAL 20171010 OTC MONOGRAPH FINAL part341 Chain Drug Consortium MENTHOL 7.5 mg/1 N 20181231 68016-044_5b4af214-1c8f-f4cc-e053-2991aa0aee8b 68016-044 HUMAN OTC DRUG sugar free menthol cough drops Menthol LOZENGE ORAL 20171011 OTC MONOGRAPH FINAL part341 Chain Drug Consortium MENTHOL 5.8 mg/1 N 20181231 68016-045_38879eff-947e-4d34-879c-98ba61cfdc67 68016-045 HUMAN OTC DRUG Aspirin Enteric Coated Regular Strength Aspirin TABLET ORAL 20141027 OTC MONOGRAPH FINAL part343 Chain Drug Consortium ASPIRIN 325 mg/1 E 20171231 68016-046_64029f1e-b681-6127-e053-2991aa0a9d1b 68016-046 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20180130 OTC MONOGRAPH FINAL part341 Chain Drug Consortium MENTHOL 7.5 mg/1 N 20191231 68016-050_f749802f-8258-4410-9781-8385ebc1c397 68016-050 HUMAN OTC DRUG Antacid Antigas Maximum Strength Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone SUSPENSION ORAL 20090603 OTC MONOGRAPH FINAL part331 Chain Drug Consortium, LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 68016-059_11748a92-d3ea-49eb-bb72-8bc856a715dd 68016-059 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20141104 ANDA ANDA079129 Chain Drug Consortium IBUPROFEN 200 mg/1 E 20171231 68016-063_0228b99a-c0a2-42f4-8f9d-b880d0c18110 68016-063 HUMAN OTC DRUG Premier Value Hydrocortisone Plus 12 Moisturizers Hydrocortisone CREAM TOPICAL 19891003 OTC MONOGRAPH NOT FINAL part348 Pharmacy Value Alliance LLC HYDROCORTISONE 1 g/100g N 20181231 68016-065_a0ade520-248d-4d51-8099-3be7716e8203 68016-065 HUMAN OTC DRUG Ibuprofen Caplet Ibuprofen CAPSULE ORAL 20141104 ANDA ANDA079129 Chain Drug Consortium IBUPROFEN 200 mg/1 E 20171231 68016-066_3fd7c5bc-9801-476f-86b6-5c93fa9a3aa7 68016-066 HUMAN OTC DRUG PREMIER VALUE PAIN RELIEF PATCHES LIDOCAINE PATCH TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part348 Chain Drug Consortium, LLC LIDOCAINE 4 g/100g N 20181231 68016-067_f3f6aae5-e840-444c-89e6-1d3ceaf4799b 68016-067 HUMAN OTC DRUG 2-Count HEAT PATCHES CAPSAICIN PATCH TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Chain Drug Consortium, LLC CAPSAICIN .025 g/100g N 20181231 68016-068_c9be72fa-e04a-4321-bdf6-af442fdd036a 68016-068 HUMAN OTC DRUG Hot and Cold Medicated Patch MENTHOL PATCH TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part348 Chain Drug Consortium, LLC MENTHOL 5 1/1 N 20181231 68016-069_a8bd401f-9c04-4675-bfb0-04298c37a435 68016-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 20090112 OTC MONOGRAPH FINAL part347 Pharmacy Value Alliance LLC PETROLATUM 1 g/g N 20181231 68016-070_b4cb8843-8811-4d06-989c-8aceeff009b7 68016-070 HUMAN OTC DRUG Premier Value Miconazole 3 Miconazole Nitrate CREAM VAGINAL 20050302 ANDA ANDA076773 Pharmacy Value Alliance LLC MICONAZOLE NITRATE 40 mg/g N 20181231 68016-071_3887ea2f-5c5e-45ba-8464-17a970d578e5 68016-071 HUMAN OTC DRUG Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Chain Drug Consortium, LLC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 6; 10 g/100g; g/100g; g/100g N 20181231 68016-072_abbed8c1-584b-490b-ba95-683742eb6f04 68016-072 HUMAN OTC DRUG Night Time Cherry DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE SYRUP ORAL 20090825 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 15; 6.25 mg/15mL; mg/15mL N 20181231 68016-073_d723d60e-25f8-47aa-88d3-b590c79f7392 68016-073 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20030911 ANDA ANDA074164 Chain Drug Consortium, LLC MICONAZOLE NITRATE 20 mg/g N 20181231 68016-075_e668129e-d90d-472d-86de-862522ed971a 68016-075 HUMAN OTC DRUG Premier Value Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20060511 OTC MONOGRAPH FINAL part333B Pharmacy Value Alliance LLC BACITRACIN ZINC 500 [iU]/g N 20181231 68016-076_dc3d9b2e-a631-42f4-b5bf-85d865721858 68016-076 HUMAN OTC DRUG Premier Value Antibiotic Plus Pain Relief Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20120321 OTC MONOGRAPH FINAL part333B Pharmacy Value Alliance LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [iU]/g; mg/g N 20181231 68016-078_93af2902-fbe5-4728-85ea-f234cb497dc5 68016-078 HUMAN OTC DRUG Milk of Magnesia Original Magnesium Hydroxide SUSPENSION ORAL 20090603 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 68016-078_d6fdb3b9-632a-4c0b-9da9-d19978be7242 68016-078 HUMAN OTC DRUG Milk of Magnesia Original Magnesium Hydroxide SUSPENSION ORAL 20090603 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 68016-080_1cc3144f-5f7f-42cb-92c4-b6d026a0cc20 68016-080 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20070702 ANDA ANDA077511 Pharmacy Value Alliance LLC TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 68016-081_106f8d88-720f-4084-a512-636e92671921 68016-081 HUMAN OTC DRUG Milk of Magnesia Mint Magnesium Hydroxide SUSPENSION ORAL 20090603 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 68016-081_4e9eadba-a6bd-4a22-aabc-437e8414b33c 68016-081 HUMAN OTC DRUG Milk of Magnesia Mint Magnesium Hydroxide SUSPENSION ORAL 20090603 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 68016-085_c25f5945-5bef-4b8f-aeca-7f8d976ee08f 68016-085 HUMAN OTC DRUG Premier Value Childrens Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Chain Drug Constortium LORATADINE 5 mg/5mL N 20181231 68016-089_e6401018-b6f1-46d8-8ad7-69d26268c976 68016-089 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin TABLET, DELAYED RELEASE ORAL 20110322 OTC MONOGRAPH FINAL part343 Chain Drug Consortium, LLC ASPIRIN 81 mg/1 N 20181231 68016-098_09f82d50-a706-4542-b653-2ad8ab969058 68016-098 HUMAN OTC DRUG Tussin Long Acting Cough Dextromethorphan HBr LIQUID ORAL 20130129 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 68016-099_96ee9fb6-b66d-4d07-ab21-97f9d9555734 68016-099 HUMAN OTC DRUG Premier Value Hydrocortisone Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Pharmacy Value Alliance LLC HYDROCORTISONE 1 g/100g N 20181231 68016-100_e7d29ccb-67db-45c4-9e96-c84fa624e1ff 68016-100 HUMAN OTC DRUG Tussin Sugar Free Dextromethorphan Hydrobromide, GUAIFENESIN LIQUID ORAL 20090209 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 68016-101_9dc121f9-cc14-4600-ab43-520f7551ecf0 68016-101 HUMAN OTC DRUG Night time sinus Acetaminophen, Doxylamine succinate, and Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100713 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 68016-102_43cb14a7-5cdf-4528-86bd-ed8255432e6b 68016-102 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20060908 OTC MONOGRAPH NOT FINAL part348 Chain Drug Consortium, LLC HYDROCORTISONE 1 g/100g N 20181231 68016-103_7b9c817f-91d9-4bbb-b805-44dc4ffd452c 68016-103 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen LIQUID ORAL 20141003 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium (Premier Value) ACETAMINOPHEN 160 mg/5mL E 20171231 68016-104_12384904-e866-4137-b4d1-1098fc02e15a 68016-104 HUMAN OTC DRUG Milk of Magnesia Wild Cherry MAGNESIUM HYDROXIDE SUSPENSION ORAL 20100108 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 68016-104_6953b77f-e0df-4140-bad1-13209534a615 68016-104 HUMAN OTC DRUG Milk of Magnesia Wild Cherry MAGNESIUM HYDROXIDE SUSPENSION ORAL 20100108 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 68016-106_51b02412-ebbd-4045-8af4-4b8b8e90daf4 68016-106 HUMAN OTC DRUG Childrens Cetirzine Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Pharmacy Value Alliance LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 68016-108_1e2e8cf1-655d-4d70-9348-8449134b8202 68016-108 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20171231 OTC MONOGRAPH FINAL part347 Chain Drug Consortium, LLC DIMETHICONE 125 mg/1 N 20191231 68016-109_0707409f-91e0-22b1-e054-00144ff8d46c 68016-109 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20051101 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC DOCUSATE SODIUM 100 mg/1 E 20171231 68016-110_07097099-a2e9-4b8d-e054-00144ff88e88 68016-110 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen, Aspirin, Caffeine TABLET, COATED ORAL 20080401 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN; 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TOLNAFTATE 10 mg/g N 20191231 68016-153_68d3f0d3-579e-4cbd-8064-ac346b292822 68016-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20011105 OTC MONOGRAPH FINAL part358H Chain Drug Consortium, LLC PYRITHIONE ZINC 1 kg/100L N 20181231 68016-154_9bd22cdf-bcc1-456b-87e1-329dec558e05 68016-154 HUMAN OTC DRUG Night Time Severe Cold and Cough Relief ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL LIQUID ORAL 20131004 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 68016-155_8a16babe-7582-40b3-8867-50baf650572c 68016-155 HUMAN OTC DRUG Flu Relief Therapy Day Time Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20090921 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 68016-156_caf5b534-d1bf-4252-b668-3c3b39a13835 68016-156 HUMAN OTC DRUG Cough Relief Dextromethorphan HBr LIQUID ORAL 20110330 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL N 20181231 68016-157_3df087e5-2756-4337-b933-934c64ae48fe 68016-157 HUMAN OTC DRUG Childrens Chest Congestion Relief GUAIFENESIN LIQUID ORAL 20120901 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC GUAIFENESIN 100 mg/5mL N 20181231 68016-158_275a2305-b65e-4a4d-9bed-fa80a7a28ad6 68016-158 HUMAN OTC DRUG Childrens Mucus Relief COUGH DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20120901 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 68016-159_62d4e5a4-459d-0b32-e053-2991aa0a1054 68016-159 HUMAN OTC DRUG Zinc Oxide 20% Zinc Oxide OINTMENT TOPICAL 20160719 OTC MONOGRAPH FINAL part347 Pharmacy Value Alliance, LLC ZINC OXIDE .2 g/g N 20191231 68016-160_991bcb88-e32d-43c9-86f9-2a9c8af5ed6a 68016-160 HUMAN OTC DRUG Infants Pain Relief Acetaminophen LIQUID ORAL 20141003 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium (Premier Value) ACETAMINOPHEN 160 mg/5mL E 20171231 68016-161_5d8f56c7-30b1-88fd-e053-2a91aa0ac73e 68016-161 HUMAN OTC DRUG Glycerin Glycerin SUPPOSITORY RECTAL 20120321 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium LLC GLYCERIN 1 g/1 N 20181231 68016-163_62e73a68-1c44-c853-e053-2991aa0afdc2 68016-163 HUMAN OTC DRUG Itch Relief Cream Zinc Acetate 0.1%, Diphenhydramine hydrochloride 2% CREAM TOPICAL 20160719 OTC MONOGRAPH FINAL part347 Pharmacy Value Alliance LLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20191231 68016-164_502beb77-7610-4ae2-b802-a16e07322770 68016-164 HUMAN OTC DRUG Premier Value Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 Chain Drug Constortium LORATADINE 5 mg/5mL N 20181231 68016-165_c385832e-d754-45e5-a9ea-69a0ec6d7afb 68016-165 HUMAN OTC DRUG Premier Value Childrens Cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Pharmacy Value Alliance LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 68016-166_0cf0f1c8-f92d-4925-85a4-b2dda679fc89 68016-166 HUMAN OTC DRUG Adult Pain Reliever/Fever Reducer acetaminophen LIQUID ORAL 20150505 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN 500 mg/15mL N 20181231 68016-167_2c525eda-1b53-4577-ae49-1dd7ad67a450 68016-167 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Pharmacy Value Alliance LLC LORATADINE 5 mg/5mL N 20181231 68016-175_d9ec5382-0091-44e2-b322-7542b5386561 68016-175 HUMAN OTC DRUG Mucus Relief Immediate Release Guaifenesin TABLET ORAL 20141229 OTC MONOGRAPH FINAL part341 Chain Drug Consortium GUAIFENESIN 400 mg/1 E 20171231 68016-178_fb03bf24-dbff-419e-82c7-04e1917b5208 68016-178 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen LIQUID ORAL 20141003 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium (Premier Value) ACETAMINOPHEN 160 mg/5mL E 20171231 68016-179_ddca884a-a2b7-42f8-bef9-1d528632b876 68016-179 HUMAN OTC DRUG Mucus Relief DM Dextromehtorphan HBr / Guaifenesin TABLET ORAL 20141105 OTC MONOGRAPH FINAL part341 Chain Drug Consortium DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 E 20171231 68016-182_3572e910-a8e9-4924-9b89-b80377550e4a 68016-182 HUMAN OTC DRUG Mucus Relief D Immediate Release Guaifenesin and Phenylephrine HCl TABLET ORAL 20141229 OTC MONOGRAPH FINAL part341 Chain Drug Consortium GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 E 20171231 68016-186_b20c28d5-3ec7-4c31-8292-003a1e59db26 68016-186 HUMAN OTC DRUG Muscle Rub Premier Value Menthol 8.00% Methyl Salicylate 30.00% CREAM TOPICAL 20111004 OTC MONOGRAPH NOT FINAL part348 Premier Value MENTHOL; METHYL SALICYLATE 8; 30 g/106mL; g/106mL N 20181231 68016-187_dcd8f665-dda6-44ce-88d8-a01743a16afe 68016-187 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET ORAL 20100708 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68016-188_d074b0da-77e3-4611-abca-518eddaae618 68016-188 HUMAN OTC DRUG Non Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20121024 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC ACETAMINOPHEN; 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DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 12.5; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 68016-299_f9563898-b7ed-4867-bba6-7803331676a2 68016-299 HUMAN OTC DRUG Cold and Chest Congestion Relief ACETAMINOPHEN, GUAIFENESIN , PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20140718 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 68016-300_b82fb59b-7ce1-4d00-80f6-9fb08e602040 68016-300 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine and Pyrilamine maleate TABLET ORAL 20130614 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 68016-302_d52c0cc9-758f-4f38-98db-eee64023d25c 68016-302 HUMAN OTC DRUG Premier Value Sleep-Aid Diphenhydramine HCL CAPSULE ORAL 20130531 OTC MONOGRAPH FINAL part341 Chain Drug Consortium LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 68016-304_dfcd7641-cc9e-4548-9953-eedc32d3d085 68016-304 HUMAN OTC DRUG Nasal Decongestant Extra Moisturizing Premier Value 0.05% Oxymetazoline HCl SPRAY NASAL 20141104 OTC MONOGRAPH FINAL part341 Chain Drug Consortium OXYMETAZOLINE HYDROCHLORIDE .05 mg/mL N 20181231 68016-306_86386976-d5c5-4d5e-bab6-28825037e677 68016-306 HUMAN OTC DRUG Premier Value Bisacodyl Laxative Bisacodyl Suppository SUPPOSITORY RECTAL 20150325 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium BISACODYL 10 mg/2000mg N 20181231 68016-308_55158443-c286-4ab5-ab0a-147ab9d68385 68016-308 HUMAN OTC DRUG No Drip Premier Value Oxymetazoline HCl Nasal Solution SPRAY NASAL 20141104 OTC MONOGRAPH FINAL part341 Chain Drug Consortium OXYMETAZOLINE HYDROCHLORIDE .05 mg/mL N 20181231 68016-309_9a036ed6-9da7-4249-984c-ca7f44c1bf1e 68016-309 HUMAN OTC DRUG No Drip Severe Congestion Premier Value Oxymetazoline HCl Nasal Solution SPRAY NASAL 20141104 OTC MONOGRAPH FINAL part341 Chain Drug Consortium OXYMETAZOLINE HYDROCHLORIDE .05 mg/mL N 20181231 68016-315_65083cb7-e30c-43d4-99e5-fc86debd1a98 68016-315 HUMAN OTC DRUG Mucus Relief DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Chain Drug Consortium, LLC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 68016-316_63288e79-a3e5-4bab-81bc-a9f75da224f4 68016-316 HUMAN OTC DRUG Nasal Decongestant Premier Value Oxymetazoline HCl 0.05% SPRAY NASAL 20141104 OTC MONOGRAPH FINAL part341 Chain Drug Consortium OXYMETAZOLINE HYDROCHLORIDE .05 mg/mL N 20181231 68016-318_cc0ab960-3eaf-4cf6-aab4-719f39773785 68016-318 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20030819 OTC MONOGRAPH NOT FINAL part356 Chain Drug Consortium EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68016-321_5a42c7d9-b02a-496c-8870-0eb17e607a0f 68016-321 HUMAN OTC DRUG Premier Value Hemorrhoidal Hemorrhoidal Rectal Suppositories SUPPOSITORY RECTAL 20150325 OTC MONOGRAPH FINAL part346 Chain Drug Consortium COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 88.44; .25 g/100g; g/100g N 20181231 68016-333_224604df-01c6-42d1-9298-b2763bcc70de 68016-333 HUMAN OTC DRUG Premier Value Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Chain Drug Consortium, LLC. ACETAMINOPHEN 650 mg/1 N 20181231 68016-336_c5e48cf2-e442-4c06-926f-1a4e135d7fe6 68016-336 HUMAN OTC DRUG Premier Value Arthritis 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Premier Value ACETAMINOPHEN 650 mg/1 N 20181231 68016-340_f7294172-76af-4571-a424-ebf27a43f67c 68016-340 HUMAN OTC DRUG Premier Value Arthritis Pain Reliever Acetaminophen TABLET, EXTENDED RELEASE ORAL 20121221 ANDA ANDA078569 Chain Drug Consortium, LLC ACETAMINOPHEN 650 mg/1 N 20181231 68016-342_b694c8a2-ed1d-46ef-93f9-c9eb9d6379ff 68016-342 HUMAN OTC DRUG Sore Throat Relief Cherry Flavor Phenol SPRAY ORAL 20141231 OTC MONOGRAPH NOT FINAL part356 Chain Drug Consortium PHENOL 1.4 g/100mL N 20181231 68016-343_af661ef0-cdc3-4146-8ae5-59795aa49650 68016-343 HUMAN OTC DRUG Sore Throat Relief Menthol Phenol SPRAY ORAL 20141231 OTC MONOGRAPH NOT FINAL part356 Chain Drug Consortium PHENOL 1.4 g/100mL N 20181231 68016-351_ddf34e72-a3b2-4904-910c-35c0f8f70858 68016-351 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20120330 ANDA ANDA200536 Premier Value RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 68016-352_f48d12b3-6601-461a-97f0-6b233e5ac724 68016-352 HUMAN OTC DRUG Ranitidine - Acid Reducer Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20120710 ANDA ANDA201745 Chain Drug Consortium, LLC. RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 68016-353_eb7fc54d-0dd6-4851-b9ab-23709ce16754 68016-353 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, CHEWABLE ORAL 20130910 ANDA ANDA090142 Chain Drug Consortium, LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 68016-369_60debe71-0bd1-4a31-e053-2991aa0a20b5 68016-369 HUMAN OTC DRUG REGULAR STRENGTH ANTACID MINT aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20120501 OTC MONOGRAPH FINAL part331 Chain Drug Consortium, LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 68016-370_323ca604-bb83-4f76-858c-d4fe461c9da7 68016-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20130131 OTC MONOGRAPH NOT FINAL part333A Pharmacy Value Alliance LLC ALCOHOL 70 mL/100mL N 20181231 68016-374_bc5867f2-f4e7-4eb5-af0f-2fe5f117053b 68016-374 HUMAN OTC DRUG Salicylic Acid One Step Clear Wart Remover PLASTER TOPICAL 20030523 OTC MONOGRAPH FINAL part358B Chain Drug Consortium, LLC SALICYLIC ACID .4 g/141 N 20181231 68016-376_7187fc1f-7dc6-4ec2-8220-f88e8f48951b 68016-376 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 68016-378_a1d59f30-9801-4496-a4bc-d7b0e6d5ffff 68016-378 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH FINAL part347 Chain Drug Consortium, LLC DIMETHICONE 125 mg/1 N 20181231 68016-381_51f14f4e-78fb-46a2-e054-00144ff8d46c 68016-381 HUMAN OTC DRUG Premier Value Antacid and Pain Relief Medicine Aspirin, Citric Acid Monohydrate, and Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20060529 20180331 OTC MONOGRAPH FINAL part343 Chain Drug Consortium, LLC ASPIRIN; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 325; 1000; 1916 mg/1; mg/1; mg/1 N 20181231 68016-382_3012d510-d966-470c-9d9d-6acd5bde3871 68016-382 HUMAN OTC DRUG Minoxidil Form Men extra strength Minoxidil SOLUTION TOPICAL 20030911 ANDA ANDA075518 Chain Drug Consortium, LLC MINOXIDIL 50 mg/mL N 20181231 68016-392_60df0f08-6619-6cb5-e053-2a91aa0a7760 68016-392 HUMAN OTC DRUG STOMACH RELIEF bismuth subsalicylate LIQUID ORAL 20140901 OTC MONOGRAPH FINAL part335 Chain Drug Consortium, LLC BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 68016-400_5c89e3ac-ca4e-ec3a-e053-2a91aa0a1c0b 68016-400 HUMAN OTC DRUG Premier Value Calaclear Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Chain Drug Consortium ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 68016-401_61b974fb-9acc-44b8-e053-2991aa0afe83 68016-401 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20120101 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC DOCUSATE SODIUM 100 mg/1 N 20191231 68016-402_1de87d1e-08eb-4826-844d-c359bb82377a 68016-402 HUMAN OTC DRUG Ultra Lubricant Eye Drops Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20140110 OTC MONOGRAPH FINAL part349 Chain Drug Consortium POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 68016-403_876fa04b-6d26-4948-b3fd-93ad027e0e49 68016-403 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20140110 ANDA ANDA077958 Chain Drug Consortium KETOTIFEN FUMARATE .35 mg/mL N 20181231 68016-404_4afaac05-13de-42d2-b6ee-f817443721d9 68016-404 HUMAN OTC DRUG Lubricant Eye Drops Polyethylene Glycol 400 and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20140110 OTC MONOGRAPH FINAL part349 Chain Drug Consortium POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 68016-405_4437434b-284d-4fed-95c9-dfe5f63a9ed5 68016-405 HUMAN OTC DRUG Moisturizing Lubricant Eye Drops Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20140110 OTC MONOGRAPH FINAL part349 Chain Drug Consortium CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL N 20181231 68016-407_48e07ed1-6cfa-41cf-90a4-f5d949874067 68016-407 HUMAN OTC DRUG Premier Value Cold Sore Treatment Camphor CREAM TOPICAL 20130416 OTC MONOGRAPH NOT FINAL part348 Premier Value BENZALKONIUM CHLORIDE; CAMPHOR (SYNTHETIC) 1.3; 30 mg/g; mg/g N 20181231 68016-409_97a6cb83-eff3-4cb0-a548-cf26269031ee 68016-409 HUMAN OTC DRUG PREMIER VALUE MEDICATED WIPES WITCH HAZEL CLOTH TOPICAL 20110601 OTC MONOGRAPH FINAL part346 CHAIN DRUG CONSORTIUM, LLC WITCH HAZEL 5 g/1 N 20181231 68016-410_ec9cf647-851b-4a1a-82f0-e1b6caf47d35 68016-410 HUMAN OTC DRUG PREMIER VALUE MEDICATED PADS WITCH HAZEL SOLUTION RECTAL; TOPICAL 20110601 OTC MONOGRAPH FINAL part346 CHAIN DRUG CONSORTIUM, LLC WITCH HAZEL .5 mL/mL N 20181231 68016-413_5c8bde5a-591e-085f-e053-2991aa0a56af 68016-413 HUMAN OTC DRUG Premiere Value Calamine Calamine 8% and Zinc Oxide 8% LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 Chain Drug Consortium ZINC OXIDE 160 mg/mL N 20181231 68016-414_24773ed4-0b18-48ad-9af7-f8db2bb52a43 68016-414 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 20131009 ANDA ANDA074165 Chain Drug Consortium, LLC CLOTRIMAZOLE 10 mg/g N 20181231 68016-415_5d027ab3-c1f5-479f-e053-2a91aa0a6952 68016-415 HUMAN OTC DRUG Premier Value Povidone Iodine Povidone Iodine 10% LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A Chain Drug Consortium POVIDONE-IODINE 100 mg/mL N 20181231 68016-420_5cc9d9db-6148-2845-e053-2991aa0a3e48 68016-420 HUMAN OTC DRUG Premier Value Calagesic Zinc Acetate and Pramoxine Hydrochloride LOTION TOPICAL 19980325 OTC MONOGRAPH FINAL part347 Chain Drug Consortuim ZINC OXIDE; 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NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 68016-515_5c8c1532-93d4-8bb1-e053-2991aa0a3dfc 68016-515 HUMAN OTC DRUG Premiere Value Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium CASTOR OIL 1 mg/mL N 20181231 68016-516_5f9d6796-f0d8-2326-e053-2a91aa0a8026 68016-516 HUMAN OTC DRUG Miconazole Nitrate Antifungal Liquid Continuous Spray AEROSOL, SPRAY TOPICAL 20100105 OTC MONOGRAPH FINAL part333C Chain Drug Consortium, LLC MICONAZOLE NITRATE 3 g/150g N 20181231 68016-523_dfb43a3f-20fa-4247-9f69-b0d4e696157b 68016-523 HUMAN OTC DRUG Premier Value Illuminating Daily Moisturizer Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Chain Drug Consortium, LLC AVOBENZONE; OCTOCRYLENE; OCTISALATE 3; 8; 5 g/100mL; g/100mL; g/100mL N 20181231 68016-526_78c14cff-325e-4106-a9a4-cb5281ceec58 68016-526 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030819 ANDA ANDA076134 Premier Value LORATADINE 10 mg/1 N 20191231 68016-527_ffe62d63-befe-4308-a676-12b3e179a32b 68016-527 HUMAN OTC DRUG Loratadine ODT Loratadine TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA077153 Chain Drug Consortium, LLC LORATADINE 10 mg/1 N 20181231 68016-528_5da428e6-ecb5-b4e6-e053-2a91aa0a119b 68016-528 HUMAN OTC DRUG HemorrhoidalOintment Mineral Oil, Petrolatum, Phenylephrine HCI OINTMENT TOPICAL 20160719 OTC MONOGRAPH FINAL part346 Pharmacy Value Alliance, LLC MINERAL OIL; 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DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20191231 68016-599_7d5786ce-4821-608c-2535-9e178cb8b155 68016-599 HUMAN OTC DRUG Nighttime Cold and flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, CAPSULE, LIQUID FILLED ORAL 20151012 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20191231 68016-600_e504cd56-59e9-36ce-d65c-6139d7f4de5e 68016-600 HUMAN OTC DRUG Daytime and Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride KIT 20150709 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC N 20191231 68016-606_5f9cd861-d97e-58c0-e053-2991aa0a38dc 68016-606 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20030523 OTC MONOGRAPH FINAL part358F Chain Drug Consortium, LLC SALICYLIC ACID 40 mg/91 N 20181231 68016-607_5f9ccd58-6209-ba80-e053-2991aa0a4617 68016-607 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20030523 OTC MONOGRAPH FINAL part358F Chain Drug Consortium, LLC SALICYLIC ACID 40 mg/41 N 20181231 68016-608_46bebf04-5e12-4f3d-8e5e-bd1f5661f140 68016-608 HUMAN OTC DRUG Tolnaftate Antifungal Spray Powder AEROSOL, SPRAY TOPICAL 20030523 OTC MONOGRAPH FINAL part333C Chain Drug Consortium, LLC TOLNAFTATE .13 g/130g N 20181231 68016-609_291a26dc-b465-4023-91e3-6b8f7c25feb7 68016-609 HUMAN OTC DRUG Tolnaftate Antifungal Spray Liquid AEROSOL, SPRAY TOPICAL 20030523 OTC MONOGRAPH FINAL part333C Chain Drug Consortium, LLC TOLNAFTATE .15 g/150g N 20181231 68016-610_603a6f99-bfe5-c6c7-e053-2a91aa0a8111 68016-610 HUMAN OTC DRUG Salicylic Acid Corn and Callus Remover LIQUID TOPICAL 20030523 OTC MONOGRAPH FINAL part358B Chain Drug Consortium, LLC SALICYLIC ACID .17 mg/15mL N 20181231 68016-611_5f9d39fb-467c-9f51-e053-2991aa0a8980 68016-611 HUMAN OTC DRUG Salicylic Acid Wart Remover LIQUID TOPICAL 20030523 OTC MONOGRAPH FINAL part358B Chain Drug Consortium, LLC SALICYLIC ACID .17 mg/15mL N 20181231 68016-614_e356bdb0-377c-4b70-8c71-62059bf733f8 68016-614 HUMAN OTC DRUG Lidocaine Burn Relief AEROSOL, SPRAY TOPICAL 20051207 OTC MONOGRAPH NOT FINAL part348 Chain Drug Consortium, LLC LIDOCAINE .64 g/127g N 20181231 68016-615_5f9ceb56-fbf4-b4ad-e053-2991aa0abd1b 68016-615 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20051207 OTC MONOGRAPH NOT FINAL part333A Chain Drug Consortium, LLC BENZETHONIUM CHLORIDE; DYCLONINE HYDROCHLORIDE .2; .75 mg/9mL; mg/9mL N 20181231 68016-618_e3e451a5-fdeb-42fd-a6af-abb7d43ac5a8 68016-618 HUMAN OTC DRUG Salicylic Acid Plantar Wart Remover PATCH TOPICAL 20090219 OTC MONOGRAPH FINAL part358F Chain Drug Consortium, LLC SALICYLIC ACID 40 mg/241 N 20181231 68016-619_60dda8cc-644d-f5d9-e053-2a91aa0ad276 68016-619 HUMAN OTC DRUG MAXIMUM STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20120501 OTC MONOGRAPH FINAL part331 Chain Drug Consortium, LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 68016-622_6140e883-8105-44f3-e053-2991aa0a1ba1 68016-622 HUMAN OTC DRUG Stool Softener with Laxative Docusate Sodium and Sennosides TABLET, FILM COATED ORAL 20141101 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 68016-624_60debb08-ce4f-0da0-e053-2a91aa0ae178 68016-624 HUMAN OTC DRUG SUPREME ANTACID calcium carbonate, magnesium hydroxide SUSPENSION ORAL 20120501 OTC MONOGRAPH FINAL part331 Chain Drug Consortium, LLC CALCIUM CARBONATE; 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PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 68016-631_f7aa0281-eca8-4b96-b3ba-8a6b8c47dfb7 68016-631 HUMAN OTC DRUG Diphenhydramine HCl and Zinc Acetate Allergy Relief Spray AEROSOL, SPRAY TOPICAL 20101210 OTC MONOGRAPH NOT FINAL part348 Chain Drug Consortium, LLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 1.52; .076 g/76g; g/76g N 20181231 68016-632_5e3b470e-1dc1-4f41-ac9f-ae175da04a88 68016-632 HUMAN OTC DRUG Salicylic Acid Wart Remover Gel GEL TOPICAL 20111020 OTC MONOGRAPH FINAL part358B Chain Drug Consortium, LLC SALICYLIC ACID .17 g/7g N 20181231 68016-633_f0d55d21-7d62-4f88-b89d-b20df6fdec58 68016-633 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Chain Drug Consortium IBUPROFEN 200 mg/1 N 20181231 68016-634_d0ec5114-262d-4677-99e9-1d1e97ac3590 68016-634 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Chain Drug Consortium IBUPROFEN 200 mg/1 N 20181231 68016-635_8c78109d-2c9e-4047-898d-1d6edb2f08f0 68016-635 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Chain Drug Consortium IBUPROFEN 200 mg/1 N 20181231 68016-636_433f3d67-4c77-4054-a46a-f2bc6995f642 68016-636 HUMAN OTC DRUG Pain Reliever Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium ACETAMINOPHEN 500 mg/1 N 20181231 68016-638_ced16e24-eec6-4f63-be46-2330e4da8a6b 68016-638 HUMAN OTC DRUG Anti-diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 Chain Drug Consortium LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 68016-639_a5266e92-54ca-4cd6-9225-fa9fc253b9f5 68016-639 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET ORAL 19900410 OTC MONOGRAPH FINAL part338 Chain Drug Consortium DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68016-640_0a0d66ba-90f7-4993-b577-504b5d04032d 68016-640 HUMAN OTC DRUG Allergy Reilef Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 Chain Drug Consortium DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68016-641_dda56b33-9e9c-4948-bc62-49a4a07bca62 68016-641 HUMAN OTC DRUG Complete Allergy Diphenhydramine HCl TABLET, FILM COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 Chain Drug Consortium DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68016-642_b4960c59-2e38-4006-9f54-b97e20f087b1 68016-642 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium ASPIRIN 81 mg/1 N 20181231 68016-643_d1ca0a8b-a12d-4d8e-b0e8-39d7998030b6 68016-643 HUMAN OTC DRUG Gas Relief Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part332 Chain Drug Consortium DIMETHICONE 125 mg/1 N 20181231 68016-645_0af97afd-a55c-4791-93fe-e88d5f26ba55 68016-645 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19880524 ANDA ANDA075010 Chain Drug Consortium IBUPROFEN 200 mg/1 N 20181231 68016-647_60dd7050-4f4b-39c0-e053-2a91aa0a5411 68016-647 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide SUSPENSION ORAL 20120501 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 68016-648_baf261fa-4fdb-488e-bef6-3ed4bc0326a8 68016-648 HUMAN OTC DRUG Miconazole Nitrate Miconazorb AF POWDER TOPICAL 20110610 OTC MONOGRAPH FINAL part333C Chain Drug Consortium, LLC MICONAZOLE NITRATE 1.42 g/71g N 20181231 68016-649_c507fe4a-1f8e-4780-a2f5-9da6e5922bef 68016-649 HUMAN OTC DRUG Premier Value Fiber Psyllium Husk CAPSULE ORAL 20110701 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC PSYLLIUM HUSK .52 g/1 N 20181231 68016-652_00a58373-77ab-4a46-9862-d179e17c731a 68016-652 HUMAN OTC DRUG Premier Value Chewable Antacid Assorted Fruit Antacid Tablets TABLET, CHEWABLE ORAL 20140207 OTC MONOGRAPH FINAL part331 Chain Drug Consortium, LLC CALCIUM CARBONATE 500 mg/1 N 20181231 68016-653_5f9ed8a7-9101-0fd6-e053-2991aa0ad919 68016-653 HUMAN OTC DRUG Tolnafate Tolnaftate Jock Itch Powder Spray - Talc Free AEROSOL, SPRAY TOPICAL 20171031 OTC MONOGRAPH FINAL part333C Chain Drug Consortium, LLC TOLNAFTATE 1.3 g/130g N 20181231 68016-654_47f839b9-ac8b-161c-e054-00144ff8d46c 68016-654 HUMAN OTC DRUG Acetaminophen Diphenhydramine HCl Acetaminophen Diphenhydramine HCl TABLET ORAL 20160225 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium,LLC ACETAMINOPHEN; 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DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 68016-709_329db4f9-39f4-4dda-9406-d7945d58c27c 68016-709 HUMAN OTC DRUG COLD and FLU Nighttime Relief Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr SOLUTION ORAL 20150727 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 68016-710_468009a3-b74d-4a0c-acec-8e90ab1a46dd 68016-710 HUMAN OTC DRUG COLD and FLU Nighttime Relief Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr SOLUTION ORAL 20150727 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 68016-712_ddd9b7a3-7ea8-43b7-b7a2-2dbab6f8f22c 68016-712 HUMAN OTC DRUG Adult Allergy DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20150504 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/20mL N 20181231 68016-713_1ef25fd2-673b-4bda-a10e-462e32b79866 68016-713 HUMAN OTC DRUG Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION ORAL 20150504 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 68016-715_470524ba-afb4-450a-b632-e91e03ed1140 68016-715 HUMAN OTC DRUG Triple Antibiotic plus Pain Relief Maximum Strength bacitracin zinc, neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride OINTMENT TOPICAL 20150710 OTC MONOGRAPH FINAL part333B Chain Drug Consortium, LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 68016-719_fa8d7c3c-c452-de6b-cab8-b4116b5dc026 68016-719 HUMAN OTC DRUG Daytime Cold and Flu Relief Plus Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride CAPSULE ORAL 20150923 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LCC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 68016-720_9c014e5b-8f18-b609-fb9b-ef592288869e 68016-720 HUMAN OTC DRUG Nighttime Cold and Flu Relief Plus Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride CAPSULE ORAL 20150923 OTC MONOGRAPH FINAL part341 Chain Drug Consortium,LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 68016-721_a78f8442-955e-6328-bcc7-fa91e0be0794 68016-721 HUMAN OTC DRUG Daytime and Nighttime Cold and Flu Relief Plus Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride KIT 20150917 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC N 20181231 68016-722_61d18ca3-fc1a-6bad-e053-2a91aa0a4df8 68016-722 HUMAN OTC DRUG Enteric coated aspirin Aspirin TABLET, COATED ORAL 20150401 OTC MONOGRAPH FINAL part343 Chain Drug Consortium, LLC ASPIRIN 325 mg/1 N 20191231 68016-723_684107a1-38ab-167b-2bf4-08321a083147 68016-723 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160229 ANDA ANDA208150 Chain Drugs Consortium, LLC FLUTICASONE PROPIONATE 50 ug/1 N 20181231 68016-724_3f1b062c-ddd9-4160-8921-f15ce96d5e27 68016-724 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041117 ANDA ANDA076557 Chain Drug Consortium, LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 68016-725_f330ea98-81eb-4999-997e-a9fb3565d411 68016-725 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen SUSPENSION ORAL 20150430 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 68016-726_60cc2d39-745d-87a4-e053-2a91aa0a8a42 68016-726 HUMAN OTC DRUG Laxative polyethylene glycol 3350 POWDER, FOR SOLUTION ORAL 20150601 ANDA ANDA090812 Chain Drug Consortium, LLC POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 68016-727_bdb688c4-d254-4d7c-9451-bbb2219f701f 68016-727 HUMAN OTC DRUG Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150630 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 68016-728_21369a86-dc3e-4323-98b6-78fcd3549df9 68016-728 HUMAN OTC DRUG Non Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20150630 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 68016-729_53429fd0-fa9d-427a-a219-5d0668b83f6a 68016-729 HUMAN OTC DRUG Cold and Allergy Childrens Brompheniramine maleate, Phenylephrine HCl LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 2; 5 mg/10mL; mg/10mL N 20181231 68016-730_26521eab-e047-46f5-9b20-ecaf3aaacd7a 68016-730 HUMAN OTC DRUG Pain Away plus Sleep aid acetaminophen, diphenhydramine hydrochloride LIQUID ORAL 20150724 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/15mL; mg/15mL N 20181231 68016-731_627d1175-8415-4381-b8e1-a7f3499bfad4 68016-731 HUMAN OTC DRUG Miconazole 3 Combination Pack Miconazole Nitrate KIT 20030911 ANDA ANDA074926 Chain Drug Consortium, LLC N 20181231 68016-732_51b0d31c-3290-46cf-9b7c-9598a0f22321 68016-732 HUMAN OTC DRUG Epsom Salt Magnesium sulfate GRANULE ORAL; TOPICAL 20170831 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC MAGNESIUM SULFATE, UNSPECIFIED 1 g/g N 20181231 68016-733_65d6722c-4fef-9dfd-387d-e6f6e2011148 68016-733 HUMAN OTC DRUG Night Time Sinus and Congestion Acetaminophen, Doxylamine succinate, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20151012 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 68016-735_1ad38333-221f-44e4-8372-6d0d586a8d5f 68016-735 HUMAN OTC DRUG Allergy Rapid Melts Childrens Diphenhydramine HCl TABLET, CHEWABLE ORAL 20110425 OTC MONOGRAPH FINAL part341 Chain Drug Consortium DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1 N 20181231 68016-736_8bd0317f-ed5e-4b93-b642-6e26016cb76d 68016-736 HUMAN OTC DRUG Menstrual Relief Maximum Strength Acetaminophen, Caffeine, Pyrilamine maleate TABLET, FILM COATED ORAL 20020429 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 68016-739_6b893125-4a8c-4b56-8a08-664882816f5b 68016-739 HUMAN OTC DRUG Laxative Maximum Strength Sennosides TABLET, SUGAR COATED ORAL 20030102 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium SENNOSIDES 25 mg/1 N 20181231 68016-746_61f84b81-99fc-626d-e053-2a91aa0a8b83 68016-746 HUMAN OTC DRUG Senna-S Sennosides and Docusate Sodium TABLET ORAL 20170501 OTC MONOGRAPH NOT FINAL part334 Chain Drug Consortium, LLC SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20191231 68016-747_f9ff48ab-8690-4bdf-ab92-f86e9d978db5 68016-747 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 Chain Drug Consortium ASPIRIN 325 mg/1 N 20181231 68016-754_2ed070c6-886c-63e5-e054-00144ff88e88 68016-754 HUMAN OTC DRUG Premier Value Multi-Symptom Severe Cold Green Tea and Honey Lemon flavors Acetaminophen, Dextromethorphan HBr and Phenylephrine HCL GRANULE, FOR SOLUTION ORAL 20160324 OTC MONOGRAPH FINAL part341 Premier Value ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 68016-755_2ecdec89-6ee6-29d9-e054-00144ff8d46c 68016-755 HUMAN OTC DRUG Premier Value night time severe cold and cough honey lemon infused with chamomile and white tea flavors Acetaminophen, Diphenhydramine HCL, and Phenylephrine HCL. GRANULE, FOR SOLUTION ORAL 20160324 OTC MONOGRAPH FINAL part341 Premier Value ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 68016-756_3d4c26c3-a62d-4684-bc93-fa9885baa828 68016-756 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20170123 ANDA ANDA203306 Chain Drug Consortium, LLC LANSOPRAZOLE 15 mg/1 N 20181231 68016-757_552595d6-3b51-48f3-bad5-f9063f353088 68016-757 HUMAN OTC DRUG Nasal Decongestant Maximum Strength Phenylephrine HCl TABLET, COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 Chain Drug Consortium PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 68016-759_616d8cae-d8bb-d56e-e053-2991aa0a86fb 68016-759 HUMAN OTC DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20130401 ANDA ANDA078878 Chain Drug Consortium, LLC OMEPRAZOLE MAGNESIUM 20.6 mg/1 N 20181231 68016-760_50337289-c74b-89e9-9808-47bd3f57cf1e 68016-760 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20160101 ANDA ANDA078878 Chain Drug Consortium, LLC OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 68016-778_61d29808-e2c1-7f9b-e053-2991aa0a4682 68016-778 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20110701 OTC MONOGRAPH FINAL part336 Chain Drug Consortium, LLC MECLIZINE HYDROCHLORIDE 25 mg/1 N 20191231 68016-804_11e9328f-4972-4d03-96c6-6fa5a62dc7b1 68016-804 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol LIQUID TOPICAL 20030815 OTC MONOGRAPH NOT FINAL part333A Pharmacy Value Alliance LLC ISOPROPYL ALCOHOL .91 mg/mL N 20181231 68016-810_918f8b27-8621-4a90-a98f-2a2c03da100e 68016-810 HUMAN OTC DRUG 70% Isopropyl alcohol LIQUID TOPICAL 20090515 OTC MONOGRAPH NOT FINAL part333A Chain Drug Corporation ISOPROPYL ALCOHOL 500 mg/mL N 20181231 68016-822_323c1fd0-af94-4c2a-ba7f-fc7a5b018391 68016-822 HUMAN OTC DRUG Witch Hazel WITCH HAZEL LIQUID TOPICAL 20030815 OTC MONOGRAPH FINAL part347 Pharmacy Vlaue Alliance LLC WITCH HAZEL 842 mg/mL N 20181231 68016-823_7abd5317-86e4-46a9-b504-8955d5861fff 68016-823 HUMAN OTC DRUG Childrens Allergy DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20120911 OTC MONOGRAPH FINAL part336 Chain Drug Consortium, LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 68016-826_cdbe6634-2f27-41d5-a53f-57b400f36589 68016-826 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20090519 OTC MONOGRAPH NOT FINAL part334 Pharmacy Value Alliance LLC MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 68016-831_d222ebab-0449-424b-83ad-f1f91a866a0c 68016-831 HUMAN OTC DRUG Premier Value Mineral OIL ORAL 20090519 OTC MONOGRAPH NOT FINAL part334 Pharmacy Value Alliance LLC MINERAL OIL 999 mg/mL N 20181231 68016-840_ab420d30-d77f-450f-8b81-24bb567fa34c 68016-840 HUMAN OTC DRUG Premier Value Hemorrhoidal Mineral oil, Petrolatum, and Phenylephrine Hydrochloride OINTMENT TOPICAL 20150211 OTC MONOGRAPH FINAL part346 Chain Drug Consortium, LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 140; 749; 2.5 mg/g; mg/g; mg/g N 20181231 68016-855_56d2cb5f-41d0-40e4-9d2b-bbabd03875a6 68016-855 HUMAN OTC DRUG Tussin DM COUGH SUPPRESSANT/EXPECTORANT DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN LIQUID ORAL 20120901 OTC MONOGRAPH FINAL part341 Chain Drug Consortium, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 68016-871_2a1e1b31-1fe5-4349-a59e-82cf14a389f9 68016-871 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20030813 OTC MONOGRAPH NOT FINAL part333A Pharmacy Value Alliance LLC HYDROGEN PEROXIDE 30 mg/mL N 20181231 68016-939_7f4668f5-9052-418e-98e2-615e6afd1445 68016-939 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077498 Chain Drug Consortium, LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 68016-941_06d93966-2a52-4e5a-81f8-2520a44789f5 68016-941 HUMAN OTC DRUG Anitseptic Mouth Rinse Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20030819 OTC MONOGRAPH NOT FINAL part348 Pharmacy Value Alliance LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68016-952_f087a8bd-5245-4d62-8843-206f52f0fec3 68016-952 HUMAN OTC DRUG Hand wash Benzalkonium chloride LIQUID TOPICAL 20140828 OTC MONOGRAPH NOT FINAL part333A Chain Drug Consortium BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 68016-995_5af62224-7b6b-8a26-ffb1-f489bd99f3c0 68016-995 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine hydrochloride TABLET ORAL 20140401 ANDA ANDA076502 Chain Drug Consortium, LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 68021-1001_14e6bc69-81e3-46c0-9ca6-232d82a0cbf8 68021-1001 HUMAN OTC DRUG Erborian BB Creme Au Ginseng TITANIUM DIOXIDE CREAM TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part352 Kolmar Korea Co Ltd TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 6.388; 3; 1.96 mL/100mL; mL/100mL; mL/100mL E 20171231 68021-1002_9ff74873-57a3-4c17-bbc8-95f652f98de6 68021-1002 HUMAN OTC DRUG Erborian BB Creme Au Ginseng Dore Titanium Dioxide CREAM TOPICAL 20101008 OTC MONOGRAPH NOT FINAL part352 Kolmar Korea Co Ltd TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 6.39; 3; 1.92 mL/100mL; mL/100mL; mL/100mL E 20171231 68022-0001_badeb55f-a1e5-486d-88fb-1b7dad9c7a73 68022-0001 HUMAN PRESCRIPTION DRUG Malathion Malathion LOTION TOPICAL 20140220 ANDA ANDA091559 Suven Life Sciences Limited MALATHION .005 g/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68025-046_3629eeea-2c10-45f5-a02c-7394409e2471 68025-046 HUMAN PRESCRIPTION DRUG Lorzone chlorzoxazone TABLET ORAL 20111001 ANDA ANDA040861 Vertical Pharmaceuticals, Inc. CHLORZOXAZONE 375 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68025-047_3629eeea-2c10-45f5-a02c-7394409e2471 68025-047 HUMAN PRESCRIPTION DRUG Lorzone chlorzoxazone TABLET ORAL 20111001 ANDA ANDA040861 Vertical Pharmaceuticals, Inc. CHLORZOXAZONE 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68025-065_5d6ca99c-490b-6288-e053-2a91aa0ae884 68025-065 HUMAN PRESCRIPTION DRUG DIVIGEL estradiol GEL TOPICAL 20141027 NDA NDA022038 Vertical Pharmaceuticals, LLC ESTRADIOL .25 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68025-066_5d6ca99c-490b-6288-e053-2a91aa0ae884 68025-066 HUMAN PRESCRIPTION DRUG DIVIGEL estradiol GEL TOPICAL 20141027 NDA NDA022038 Vertical Pharmaceuticals, LLC ESTRADIOL .5 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68025-067_5d6ca99c-490b-6288-e053-2a91aa0ae884 68025-067 HUMAN PRESCRIPTION DRUG DIVIGEL estradiol GEL TOPICAL 20141027 NDA NDA022038 Vertical Pharmaceuticals, LLC ESTRADIOL 1 mg/g Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68025-071_e18ce486-bfb7-4f1f-b44b-948d9040aa44 68025-071 HUMAN PRESCRIPTION DRUG ConZip tramadol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110831 NDA NDA022370 Vertical Pharmaceuticals, LLC TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68025-072_e18ce486-bfb7-4f1f-b44b-948d9040aa44 68025-072 HUMAN PRESCRIPTION DRUG ConZip tramadol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110831 NDA NDA022370 Vertical Pharmaceuticals, LLC TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68025-073_e18ce486-bfb7-4f1f-b44b-948d9040aa44 68025-073 HUMAN PRESCRIPTION DRUG ConZip tramadol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110831 NDA NDA022370 Vertical Pharmaceuticals, LLC TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68025-079_5d167b1f-e5ca-353b-e053-2991aa0a3d1d 68025-079 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA AUTHORIZED GENERIC NDA022104 Vertical Pharmaceuticals, LLC VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68025-080_5d167b1f-e5ca-353b-e053-2991aa0a3d1d 68025-080 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA AUTHORIZED GENERIC NDA022104 Vertical Pharmaceuticals, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68025-081_5d167b1f-e5ca-353b-e053-2991aa0a3d1d 68025-081 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA AUTHORIZED GENERIC NDA022104 Vertical Pharmaceuticals, LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68025-082_5d167b1f-e5ca-353b-e053-2991aa0a3d1d 68025-082 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride venlafaxine hydrochloride TABLET, EXTENDED RELEASE ORAL 20100429 NDA AUTHORIZED GENERIC NDA022104 Vertical Pharmaceuticals, LLC VENLAFAXINE HYDROCHLORIDE 225 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68026-116_20fb6c4f-8ea1-532a-e054-00144ff8d46c 68026-116 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Creme Peche Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-117_20fa7d8b-2bc3-503a-e054-00144ff88e88 68026-117 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Peche Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-118_20fa7d8b-2bbf-503a-e054-00144ff88e88 68026-118 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Honey Beige Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-119_20fa7d8b-2bbc-503a-e054-00144ff88e88 68026-119 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Soleil Peche Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-120_20f97683-05e3-4202-e054-00144ff88e88 68026-120 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Mocha Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-121_20f95cd5-b959-66d1-e054-00144ff8d46c 68026-121 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Soft Ivory Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-122_20f91f77-545e-32b8-e054-00144ff88e88 68026-122 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 -Tender Ivory Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-123_20e4a1d2-0c7c-6852-e054-00144ff88e88 68026-123 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 -Warm Linen Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-124_20d3531b-97f7-53fd-e054-00144ff8d46c 68026-124 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Soleil Beige Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-125_20d2e1fd-5888-0477-e054-00144ff88e88 68026-125 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Caramel Beige Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-126_20d2d287-3486-02e3-e054-00144ff88e88 68026-126 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Amber Beige Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-127_20d2ad2a-0ee4-732d-e054-00144ff88e88 68026-127 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Warm Beige Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-128_20d25c9d-c374-1355-e054-00144ff8d46c 68026-128 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Warm Ivory Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-129_20d25c9d-c369-1355-e054-00144ff8d46c 68026-129 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Buff Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-130_20d24c7d-69d4-02b9-e054-00144ff8d46c 68026-130 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Porcelaine Blush Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-131_20d080fd-50ae-310f-e054-00144ff88e88 68026-131 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Golden Beige Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-133_2095b38c-92c8-61d6-e054-00144ff8d46c 68026-133 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Petal Octinoxate 6.0% LOTION TOPICAL 20150831 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-134_4f96f100-5535-19cc-e054-00144ff88e88 68026-134 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 - Pure Ivory Octinoxate 6.0% LOTION TOPICAL 20170807 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-135_4f972bfd-fe16-20a1-e054-00144ff88e88 68026-135 HUMAN OTC DRUG Skin Caviar Foundation Sunscreen SPF 15 -Satin Nude Octinoxate 6.0% LOTION TOPICAL 20170807 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc OCTINOXATE 60 mg/mL N 20181231 68026-140_2ffac964-bfc7-0efe-e054-00144ff88e88 68026-140 HUMAN OTC DRUG Cellular Swiss Protection Veil Broad Spectrum SPF 50 Octinoxate Oxybenzone Titanium Dioxide Zinc Oxide CREAM TOPICAL 20160408 OTC MONOGRAPH NOT FINAL part352 La Prairie OCTINOXATE; OXYBENZONE; ZINC OXIDE; TITANIUM DIOXIDE 75; 50; 186; 19 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68026-201_346074c1-49ef-18fd-e054-00144ff8d46c 68026-201 HUMAN OTC DRUG Cellular Swiss Ice Crystal Transforming Cream SPF 30 - Rose Octinoxate 7.5% Zinc Oxide 7.4% CREAM TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc ZINC OXIDE; OCTINOXATE 74; 75 mg/mL; mg/mL N 20181231 68026-202_3461b708-0f84-585c-e054-00144ff8d46c 68026-202 HUMAN OTC DRUG Cellular Swiss Ice Crystal Transforming Cream SPF 30 - Nude Octinoxate 7.5% Zinc Oxide 7.4% CREAM TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc ZINC OXIDE; OCTINOXATE 74; 75 mg/mL; mg/mL N 20181231 68026-203_3461b708-0f8b-585c-e054-00144ff8d46c 68026-203 HUMAN OTC DRUG Cellular Swiss Ice Crystal Transforming Cream SPF 30 - Beige Octinoxate 7.5% Zinc Oxide 7.4% CREAM TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc ZINC OXIDE; OCTINOXATE 74; 75 mg/mL; mg/mL N 20181231 68026-204_34623f32-20bd-6ad3-e054-00144ff88e88 68026-204 HUMAN OTC DRUG Cellular Swiss Ice Crystal Transforming Cream SPF 30 - Tan Octinoxate 7.5% Zinc Oxide 7.4% CREAM TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc ZINC OXIDE; OCTINOXATE 74; 75 mg/mL; mg/mL N 20181231 68026-501_6171ea08-a140-429f-e053-2a91aa0a614d 68026-501 HUMAN OTC DRUG ANTI-AGING EYE SUNSCREEN BROAD SPECTRUM SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20110412 OTC MONOGRAPH FINAL part352 La Prairie, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 20; 75; 30 mg/mL; mg/mL; mg/mL N 20181231 68026-502_6171ea08-a124-429f-e053-2a91aa0a614d 68026-502 HUMAN OTC DRUG ANTI-AGING SUNSCREEN BROAD SPECTRUM SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 28; 75; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68026-503_6171ea08-a14c-429f-e053-2a91aa0a614d 68026-503 HUMAN OTC DRUG ANTI-AGING DAY SUNSCREEN BROAD SPECTRUM SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 75; 50; 25 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68026-521_5fd72033-c6dd-1aed-e053-2991aa0a7391 68026-521 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 100 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL N 20181231 68026-522_604e5e57-3b5d-3da0-e053-2991aa0a55f8 68026-522 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 200 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL N 20181231 68026-523_5fd72033-c6ef-1aed-e053-2991aa0a7391 68026-523 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 300 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL N 20181231 68026-524_5fd72033-c701-1aed-e053-2991aa0a7391 68026-524 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 400 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL N 20181231 68026-525_5fd75068-868b-73fc-e053-2991aa0a7bad 68026-525 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 500 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL N 20181231 68026-526_5fd752a1-4a75-08c6-e053-2a91aa0afc17 68026-526 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 600 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL N 20181231 68026-527_5fd752a1-4a86-08c6-e053-2a91aa0afc17 68026-527 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 700 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL N 20181231 68026-528_5fd734ad-66a6-3774-e053-2991aa0a85b4 68026-528 HUMAN OTC DRUG Anti-Aging Foundation SPF 15 Shade 800 OCTINOXATE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE 75 mg/mL N 20181231 68026-650_6171ea08-a15c-429f-e053-2a91aa0a614d 68026-650 HUMAN OTC DRUG CELLULAR RADIANCE SUNSCREEN SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE EMULSION TOPICAL 20131022 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 30 mg/mL; mg/mL; mg/mL N 20181231 68026-700_454ae1e2-e4dc-424a-e054-00144ff8d46c 68026-700 HUMAN OTC DRUG Line Interception Power Duo Day Cream Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 La Prairie, Inc HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 90; 27; 45; 90 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68040-702_4acf85e5-f2d5-40b0-8562-2427a2ab56be 68040-702 HUMAN PRESCRIPTION DRUG Alcortin 1% iodoquinol - 2% hydrocortisone GEL TOPICAL 20030725 UNAPPROVED DRUG OTHER Primus Pharmaceuticals HYDROCORTISONE; IODOQUINOL 2; 1 g/100g; g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68040-705_9cb495f1-7fac-495a-8775-c9388c8a15d3 68040-705 HUMAN PRESCRIPTION DRUG Alcortin A HYDROCORTISONE ACETATE, ALOE VERA LEAF and Iodoquinol GEL TOPICAL 20100101 UNAPPROVED OTHER Primus Pharmaceuticals HYDROCORTISONE ACETATE; ALOE VERA LEAF; IODOQUINOL 20; 10; 10 mg/g; mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68040-706_610958fb-6663-430c-854a-1b7f36c8c80a 68040-706 HUMAN PRESCRIPTION DRUG Aloquin Aloe Vera Leaf and Iodoquinol GEL TOPICAL 20090706 UNAPPROVED OTHER Primus Pharmaceuticals ALOE VERA LEAF; IODOQUINOL 10; 12.5 mg/g; mg/g E 20171231 68046-001_597ffa8b-a6a4-49db-b878-f17327bc97b6 68046-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130823 UNAPPROVED MEDICAL GAS P.A.L. Home Diagnostics & Respiratory Care Inc. OXYGEN 99 L/100L E 20171231 68047-120_5b6096b5-73c3-e874-e053-2991aa0a5c61 68047-120 HUMAN OTC DRUG LoHist D Chlorpheniramine Maleate / Pseudoephedrine HCl LIQUID ORAL 20030915 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 2; 30 mg/5mL; mg/5mL N 20181231 68047-129_5b6ed1d5-7642-09d4-e053-2a91aa0a5cbb 68047-129 HUMAN OTC DRUG LoHist DM Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20120601 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 68047-143_5b603853-951e-4aa3-e053-2a91aa0a953a 68047-143 HUMAN OTC DRUG EndaCof DM Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20120330 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 68047-185_5b739e04-2742-5828-e053-2991aa0af2ac 68047-185 HUMAN OTC DRUG NoHist LQ Chlorpheniramine Maleate and Phenylephrine Hydrochloride LIQUID ORAL 20110106 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/5mL; mg/5mL N 20181231 68047-186_5b6f4e54-4219-601a-e053-2991aa0a0e87 68047-186 HUMAN OTC DRUG NoHist DM Chlorpheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID ORAL 20110106 OTC MONOGRAPH FINAL part341 Larken Laboratories, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 4; 10; 15 mg/5mL; mg/5mL; mg/5mL N 20181231 68047-252_5b744c1a-dae8-d187-e053-2991aa0a7bb1 68047-252 HUMAN PRESCRIPTION DRUG OSCIMIN Hyoscyamine Sulfate TABLET ORAL 20110803 UNAPPROVED DRUG OTHER Larken Laboratories, Inc. HYOSCYAMINE SULFATE .125 mg/1 N 20181231 68047-253_5b73c866-0050-2192-e053-2991aa0ad212 68047-253 HUMAN PRESCRIPTION DRUG OSCIMIN Hyoscyamine Sulfate TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20110803 UNAPPROVED DRUG OTHER Larken Laboratories, Inc. HYOSCYAMINE SULFATE .125 mg/1 N 20181231 68047-254_5b7448a2-effd-7e13-e053-2a91aa0a3cb9 68047-254 HUMAN PRESCRIPTION DRUG OSCIMIN Hyoscyamine Sulfate TABLET, ORALLY DISINTEGRATING ORAL 20110803 UNAPPROVED DRUG OTHER Larken Laboratories, Inc. HYOSCYAMINE SULFATE .125 mg/1 N 20181231 68047-255_5b7477d6-98c6-58dc-e053-2991aa0a949a 68047-255 HUMAN PRESCRIPTION DRUG OSCIMIN Hyoscyamine Sulfate TABLET, EXTENDED RELEASE ORAL 20110803 UNAPPROVED DRUG OTHER Larken Laboratories, Inc. HYOSCYAMINE SULFATE .375 mg/1 N 20181231 68047-702_549c9319-d952-51b9-e054-00144ff88e88 68047-702 HUMAN PRESCRIPTION DRUG Dexamethasone 1.5 mg Dexamethasone 1.5 mg TABLET ORAL 20170901 ANDA ANDA201270 Larken Laboratories, Inc. DEXAMETHASONE 1.5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68047-713_5be76317-beec-0048-e053-2991aa0a61f9 68047-713 HUMAN PRESCRIPTION DRUG OFLOXACIN ofloxacin TABLET, FILM COATED ORAL 20140520 ANDA ANDA076093 Larken Laboratories, Inc. OFLOXACIN 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68047-714_63d79530-85a9-4939-a0e1-a78722ab4f07 68047-714 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20101115 ANDA ANDA065287 Larken Laboratories, Inc. DOXYCYCLINE HYCLATE 20 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 68047-720_5ae54790-fd03-28f4-e053-2a91aa0a05c5 68047-720 HUMAN PRESCRIPTION DRUG Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Acetaminophen, Caffeine and Dihydrocodeine Bitartrate TABLET ORAL 20161004 ANDA ANDA204209 Larken Laboratories Inc. ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 325; 30; 16 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 68047-721_268e4560-fc14-0b28-e054-00144ff88e88 68047-721 HUMAN PRESCRIPTION DRUG Butalbital And Acetaminophen butalbital and acetaminophen TABLET ORAL 20151204 ANDA ANDA203484 Larken Laboratories, Inc. BUTALBITAL; ACETAMINOPHEN 50; 325 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] E 20171231 68047-722_268e4560-fc14-0b28-e054-00144ff88e88 68047-722 HUMAN PRESCRIPTION DRUG ALLZITAL butalbital and acetaminophen TABLET ORAL 20151204 ANDA ANDA203484 Larken Laboratories, Inc. BUTALBITAL; ACETAMINOPHEN 25; 325 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] E 20171231 68047-723_4e783b06-cbba-5d66-e054-00144ff88e88 68047-723 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160630 ANDA ANDA202935 Larken Laboratories Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 68047-724_4e783b06-cbba-5d66-e054-00144ff88e88 68047-724 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160630 ANDA ANDA202935 Larken Laboratories Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 68047-725_4e783b06-cbba-5d66-e054-00144ff88e88 68047-725 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160630 ANDA ANDA202935 Larken Laboratories Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 68048-822_a33b8d79-3c08-4d7c-a131-c006d06d541b 68048-822 HUMAN OTC DRUG Jimin Zhuifeng Gao Menthol, Methyl Salicylate PLASTER TRANSDERMAL 20070701 OTC MONOGRAPH NOT FINAL part348 Guangdong Zhanjiang Jimin Pharmaceutical Co. Ltd MENTHOL; METHYL SALICYLATE 9; 9 g/100g; g/100g E 20171231 68048-922_6a4b574a-93bb-425c-87a3-8638c72f7bcb 68048-922 HUMAN OTC DRUG Shennong Analgesic Plaster Camphor, Menthol, Methyl Salicylate PLASTER TRANSDERMAL 20160601 OTC MONOGRAPH NOT FINAL part348 Guangdong Zhanjiang Jimin Pharmaceutical Co. Ltd CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 4.28; 2.84; 1.4 mg/100mg; mg/100mg; mg/100mg E 20171231 68055-346_42b557df-6f31-03dd-e054-00144ff88e88 68055-346 HUMAN PRESCRIPTION DRUG Baclofen Baclofen INJECTION INTRATHECAL 20160509 ANDA ANDA091193 Sintetica S.A. BACLOFEN .05 mg/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68055-415_42b557df-6f31-03dd-e054-00144ff88e88 68055-415 HUMAN PRESCRIPTION DRUG Baclofen Baclofen INJECTION INTRATHECAL 20160509 ANDA ANDA091193 Sintetica S.A. BACLOFEN 10 mg/20mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68055-416_42b557df-6f31-03dd-e054-00144ff88e88 68055-416 HUMAN PRESCRIPTION DRUG Baclofen Baclofen INJECTION INTRATHECAL 20160509 ANDA ANDA091193 Sintetica S.A. BACLOFEN 40 mg/20mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68055-699_5abd475c-5686-749a-e053-2991aa0aaeea 68055-699 HUMAN PRESCRIPTION DRUG Clorotekal CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION INTRATHECAL 20171004 NDA NDA208791 Sintetica SA CHLOROPROCAINE HYDROCHLORIDE 10 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 68062-9098_5bb40e9e-6103-ade0-e053-2a91aa0a6fd9 68062-9098 HUMAN OTC DRUG Pharmaskincare Solar-C Moisturizer SPF 50 octinoxate, zinc oxide LOTION TOPICAL 20171010 OTC MONOGRAPH FINAL part352 Spa de Soleil ZINC OXIDE; OCTINOXATE .238; .188 mg/2.5mL; mg/2.5mL N 20181231 68062-9099_5bb40443-050e-0bd8-e053-2a91aa0a9a1d 68062-9099 HUMAN OTC DRUG Pharmaskincare Solar-C Moisturizer SPF 30 titanium dioxide LOTION TOPICAL 20171010 OTC MONOGRAPH FINAL part352 Spa de Soleil TITANIUM DIOXIDE .2625 mg/2.5mL N 20181231 68062-9100_5b3d3d9c-b1f9-b4e0-e053-2a91aa0afa20 68062-9100 HUMAN OTC DRUG Pharmaskincare Solar-C Moisturizer SPF 15 zinc oxide LOTION TOPICAL 20171010 OTC MONOGRAPH FINAL part352 Spa de Soleil ZINC OXIDE .13 mg/2.5mL N 20181231 68062-9103_5b49ffb5-ade8-71bd-e053-2a91aa0a865e 68062-9103 HUMAN OTC DRUG Pharmaskincare Brightening Dermarelief Cream hydrocortisone LOTION TOPICAL 20171010 OTC MONOGRAPH NOT FINAL part348 Spa de Soleil HYDROCORTISONE .025 mg/2.5mL N 20181231 68062-9104_5b4ecd81-15bd-28b3-e053-2991aa0adc9c 68062-9104 HUMAN OTC DRUG Pharmaskincare Parfait Lightening Serum hydroquinone LOTION TOPICAL 20171010 OTC MONOGRAPH NOT FINAL part358A Spa de Soleil HYDROQUINONE .05 mg/2.5mL N 20181231 68062-9105_5b4f76c9-b07d-2f23-e053-2991aa0aa82f 68062-9105 HUMAN OTC DRUG Pharmaskincare Serum Skin Lightening hydroquinone LOTION TOPICAL 20171010 OTC MONOGRAPH NOT FINAL part358A Spa de Soleil HYDROQUINONE .05 mg/2.5mL N 20181231 68062-9106_5b4e8ef1-2985-cf1c-e053-2a91aa0aa771 68062-9106 HUMAN OTC DRUG Pharmaskincare Multi-Gly Skin Relief Cream hydrocortisone LOTION TOPICAL 20171010 OTC MONOGRAPH NOT FINAL part348 Spa de Soleil HYDROCORTISONE .025 mg/2.5mL N 20181231 68062-9107_5b4f1318-0d98-7bf2-e053-2991aa0a3408 68062-9107 HUMAN OTC DRUG Pharmaskincare Acnecare Cleanser benzoyl peroxide SOLUTION TOPICAL 20171010 OTC MONOGRAPH FINAL part333D Spa de Soleil BENZOYL PEROXIDE .063 mg/2.5mL N 20181231 68062-9108_5b4eb36d-693c-d327-e053-2a91aa0a5eb3 68062-9108 HUMAN OTC DRUG Pharmaskincare Acnecare Cream hydrocortisone LOTION TOPICAL 20171010 OTC MONOGRAPH NOT FINAL part348 Spa de Soleil HYDROCORTISONE .025 mg/2.5mL N 20181231 68062-9109_5b4fdf3a-2bba-54b7-e053-2991aa0aca8c 68062-9109 HUMAN OTC DRUG Pharmaskincare Acnecare Dermacontrol Cream benzoyl peroxide LOTION TOPICAL 20171010 OTC MONOGRAPH FINAL part333D Spa de Soleil BENZOYL PEROXIDE .063 mg/2.5mL N 20181231 68062-9110_5b501566-02a5-1801-e053-2a91aa0ae5da 68062-9110 HUMAN OTC DRUG Pharmaskincare Acnecare Exfoliator salicylic acid SOLUTION TOPICAL 20171010 OTC MONOGRAPH FINAL part333D Spa de Soleil SALICYLIC ACID .013 mg/2.5mL N 20181231 68062-9111_5b526f80-424e-53fd-e053-2991aa0abf17 68062-9111 HUMAN OTC DRUG Pharmaskincare Acnecare Toner salicylic acid SOLUTION TOPICAL 20171010 OTC MONOGRAPH FINAL part333D Spa de Soleil SALICYLIC ACID .013 mg/2.5mL N 20181231 68071-1026_4b81c0b2-94e6-4f16-e054-00144ff88e88 68071-1026 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 NuCare Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-1054_4be79c9e-9596-0ef1-e054-00144ff88e88 68071-1054 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 NuCare Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68071-1146_4fc0486c-b8dd-5486-e054-00144ff88e88 68071-1146 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 NuCare Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-1212_4b82425c-dffd-61db-e054-00144ff88e88 68071-1212 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 NuCare Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-1255_4b7dc048-4532-3bd4-e054-00144ff88e88 68071-1255 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20100315 ANDA ANDA090510 NuCare Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-1288_4fc07e98-fe54-3935-e054-00144ff8d46c 68071-1288 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 NuCare Pharmaceuticals, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-1292_492452d6-2b31-39c0-e054-00144ff8d46c 68071-1292 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 NuCare Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-1317_549aac34-8cd2-0561-e054-00144ff88e88 68071-1317 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 NuCare Pharmaceuticals,Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-1318_552cf901-1403-011a-e054-00144ff8d46c 68071-1318 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 NuCare pharmaceuticals,Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-1323_57825cb5-9e62-7c48-e053-2a91aa0a3cd7 68071-1323 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 NuCare Pharmaceuticals,Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-1330_54b37bcc-a8d1-0c17-e054-00144ff8d46c 68071-1330 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET SUBLINGUAL 20160829 ANDA ANDA208191 NuCare Pharmaceuticals,Inc. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68071-1332_589aba9d-52b3-1197-e053-2a91aa0aab41 68071-1332 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 19950929 ANDA ANDA040074 NuCare Pharmaceuticals,Inc. PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] N 20181231 68071-1333_55f26e31-f677-04dd-e054-00144ff8d46c 68071-1333 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 19851223 NDA NDA018810 NuCare Pharmaceuticals,Inc. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 68071-1368_5d932670-f6d2-073e-e053-2991aa0ae091 68071-1368 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 NuCare Pharmaceuticals,Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68071-1372_5b709152-f43d-f5e6-e053-2991aa0a3ffa 68071-1372 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20100227 ANDA ANDA076805 NuCare Pharmaceuticals,Inc. LORATADINE 5 mg/5mL N 20181231 68071-1392_4b43e1c7-0f2f-1c2a-e054-00144ff8d46c 68071-1392 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065153 NuCare Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-1419_4be72741-4f6e-6689-e054-00144ff8d46c 68071-1419 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20130301 ANDA ANDA201991 NuCare Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-1462_55f21788-aa41-1510-e054-00144ff88e88 68071-1462 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 20180731 ANDA ANDA077797 NuCare Pharmaceuticals,Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68071-1515_55b36985-64ee-3c17-e054-00144ff8d46c 68071-1515 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-1516_4adfa75f-d0be-48d1-e054-00144ff8d46c 68071-1516 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-1517_54b3634a-b094-3195-e054-00144ff88e88 68071-1517 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 NuCare Pharmaceuticals,iNc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-1518_552a998c-bfad-0288-e054-00144ff88e88 68071-1518 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-1523_549e48a5-be63-0042-e054-00144ff8d46c 68071-1523 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20111101 ANDA ANDA200292 NuCare Pharmaceuticals,Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68071-1524_56e6cd3d-2742-1224-e054-00144ff88e88 68071-1524 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20070919 ANDA ANDA077623 NuCare Pharmaceuticals,Inc. CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 68071-1525_55f4153f-4eee-6565-e054-00144ff88e88 68071-1525 HUMAN PRESCRIPTION DRUG PROAIR HFA Albuterol Sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20121203 NDA NDA021457 NuCare Pharmaceuticals,Inc. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68071-1526_56d2621a-7b98-520d-e054-00144ff8d46c 68071-1526 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 NuCare Pharmaceuticals,Inc. AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-1527_549cdd0a-da7a-23b8-e054-00144ff8d46c 68071-1527 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101228 ANDA ANDA065246 NuCare Pharmaceuticals,Inc. AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-1528_549cdd0a-dabe-23b8-e054-00144ff8d46c 68071-1528 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101217 ANDA ANDA065246 NuCare Pharmaceuticals,Inc. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-1530_54271cf1-802c-1475-e054-00144ff88e88 68071-1530 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20080320 ANDA ANDA077689 NuCare Pharmaceuticals,Inc. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68071-1533_552c74b7-0b7a-63dc-e054-00144ff8d46c 68071-1533 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 NuCare Pharmaceuticals,Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68071-1538_5528b0c7-b512-3214-e054-00144ff88e88 68071-1538 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20080528 ANDA ANDA078541 NuCare Pharmaceuticals,Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1547_553fcc9e-b728-07ac-e054-00144ff8d46c 68071-1547 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 NuCare Pharmaceuticals,Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-1548_552b5106-8d44-199d-e054-00144ff88e88 68071-1548 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 NuCare Pharmacuticals,Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68071-1549_60b61131-3c4a-4863-e053-2a91aa0af881 68071-1549 HUMAN OTC DRUG Laxacin Docusate sodium and sennosides TABLET ORAL 20111001 OTC MONOGRAPH NOT FINAL part334 NuCare Pharmaceuticals,Inc. DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 N 20181231 68071-1550_615bcd8c-b899-5463-e053-2991aa0a44a8 68071-1550 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110301 ANDA ANDA075693 NuCare Pharmaceuticals,Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68071-1551_54d9eea7-8c83-2acf-e054-00144ff8d46c 68071-1551 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 NuCare pharmaceuticals,Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1552_5a5a4040-535e-54ac-e053-2991aa0aa4ab 68071-1552 HUMAN OTC DRUG Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 NuCare Pharmaceuticals,Inc. ACETAMINOPHEN 650 mg/1 N 20181231 68071-1553_51f2105c-908c-6c34-e054-00144ff8d46c 68071-1553 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160804 ANDA ANDA205519 NuCare Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1556_5526b9c1-3abc-57a5-e054-00144ff8d46c 68071-1556 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1557_565966b5-9ef4-4142-e054-00144ff8d46c 68071-1557 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060401 ANDA ANDA076467 NuCare Pharmaceuticals,Inc. GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-1558_57867cd1-6dec-dbe8-e053-2a91aa0a3df8 68071-1558 HUMAN PRESCRIPTION DRUG TIMOLOL MALEATE timolol maleate SOLUTION/ DROPS OPHTHALMIC 20141215 ANDA ANDA077259 NuCare Pharmaceuticals,Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-1562_54255033-c2a2-042b-e054-00144ff8d46c 68071-1562 HUMAN PRESCRIPTION DRUG LACTULOSE LACTULOSE SOLUTION ORAL 19660730 ANDA ANDA074623 NuCare Pharmaceuticals, Inc. LACTULOSE 10 g/15mL Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] N 20181231 68071-1563_553bef7f-cc74-494b-e054-00144ff8d46c 68071-1563 HUMAN PRESCRIPTION DRUG Timolol Maleate Timolol Maleate SOLUTION/ DROPS OPHTHALMIC 20120326 ANDA ANDA074466 NuCare Pharmaceuticals,Inc. TIMOLOL MALEATE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-1566_61d1088e-b36c-a1ce-e053-2a91aa0aee73 68071-1566 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 NuCare Pharmaceuticals,Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68071-1571_55f2d95f-b923-3765-e054-00144ff88e88 68071-1571 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 NuCare Pharmaceuticals,Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68071-1572_51f43966-859a-161b-e054-00144ff88e88 68071-1572 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20111101 ANDA ANDA200292 NuCare Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68071-1578_549de132-172b-0ab2-e054-00144ff88e88 68071-1578 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET ORAL 20121016 ANDA ANDA202928 NuCare Pharmaceuticals,Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68071-1579_61570857-69e0-7051-e053-2a91aa0a9cc3 68071-1579 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110106 ANDA ANDA090899 NuCare Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-1581_592d1262-1b89-2fa2-e053-2991aa0a27fc 68071-1581 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone OINTMENT TOPICAL 19930528 ANDA ANDA081203 NuCare Pharmaceuticals,Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1584_4ae091f6-5889-535d-e054-00144ff88e88 68071-1584 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065223 NuCare Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-1585_55f4153f-4eb4-6565-e054-00144ff88e88 68071-1585 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20070412 ANDA ANDA065326 NuCare Pharmaceuticals,Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-1593_58b1676d-1294-5c90-e053-2991aa0afb15 68071-1593 HUMAN PRESCRIPTION DRUG clotrimazole and betamethasone dipropionate clotrimazole and betamethasone dipropionate CREAM TOPICAL 20070103 ANDA ANDA076002 NuCare Pharamceuticals,Inc. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1594_5516ba6d-28f4-2323-e054-00144ff88e88 68071-1594 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 NuCare Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-1601_54dac6a4-600b-5333-e054-00144ff8d46c 68071-1601 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 NuCare Pharmaceuticals,Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68071-1605_5a5b2c83-b192-2054-e053-2991aa0a1a32 68071-1605 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20101217 ANDA ANDA065246 NuCare Pharmaceuticals,Inc. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-1606_575c4df3-e5ff-0def-e053-2a91aa0afa51 68071-1606 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SOLUTION ORAL 20060131 ANDA ANDA040650 NuCare Pharmaceuticals,Inc. PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 68071-1607_51f3d155-36e0-4c40-e054-00144ff8d46c 68071-1607 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20080701 ANDA ANDA076407 NuCare Pharmaceuticals, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68071-1608_58270fd7-1d84-19ae-e053-2a91aa0ab9b7 68071-1608 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine Ciclopirox Olamine CREAM TOPICAL 20091113 ANDA ANDA090273 NuCare Pharmaceuticals,Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 68071-1613_566bfc71-ce01-4035-e054-00144ff88e88 68071-1613 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-1614_5878db25-72db-c0b8-e053-2a91aa0ab9b3 68071-1614 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 NuCare Pharmaceuticals,Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68071-1616_54268777-2052-03c9-e054-00144ff88e88 68071-1616 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20080320 ANDA ANDA077689 NuCare Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68071-1617_553fc7bd-0828-0730-e054-00144ff8d46c 68071-1617 HUMAN OTC DRUG Muscle Rub Menthol, Methyl salicylate CREAM TOPICAL 20110303 OTC MONOGRAPH NOT FINAL part348 NuCare Pharmaceuticals,Inc. MENTHOL; METHYL SALICYLATE 10; 15 g/100g; g/100g N 20181231 68071-1618_543b3970-16ec-0fb4-e054-00144ff8d46c 68071-1618 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 Nucare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANIC ACID 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-1619_5d074fe6-1ee1-40d8-e053-2a91aa0a7549 68071-1619 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 NuCare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANIC ACID 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-1621_564168a8-9414-5187-e054-00144ff88e88 68071-1621 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 NuCare Pharmaceuticals,Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 68071-1623_56baeefd-bebd-32d5-e054-00144ff8d46c 68071-1623 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE TOPICAL 20100707 ANDA ANDA040771 NuCare Pharmaceuticals,Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1624_5786a559-a388-120d-e053-2991aa0ab647 68071-1624 HUMAN OTC DRUG Dr Sheffield Muscle Rub Cream Muscle Rub Cream CREAM TOPICAL 20020424 OTC MONOGRAPH NOT FINAL part348 NuCare Pharmaceuticals,Inc. MENTHOL; METHYL SALICYLATE 100; 150 mg/g; mg/g N 20181231 68071-1625_5900691d-8b51-7752-e053-2991aa0a5c5c 68071-1625 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20030925 ANDA ANDA076290 NuCare Pharamceuticals,Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 68071-1629_589c5d77-27e8-97d5-e053-2991aa0a5b7a 68071-1629 HUMAN PRESCRIPTION DRUG CIPRODEX ciprofloxacin and dexamethasone SUSPENSION/ DROPS AURICULAR (OTIC) 20030804 NDA NDA021537 NuCare Pharmaceuticals,Inc. CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE 3; 1 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68071-1635_55268bf0-6ec2-4ef5-e054-00144ff8d46c 68071-1635 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20080923 ANDA ANDA078930 NuCare Pharmaceuticals,Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1638_549ff4f2-fa69-3dd8-e054-00144ff8d46c 68071-1638 HUMAN PRESCRIPTION DRUG Fluticasone Fluticasone Propionate SPRAY, METERED NASAL 20120109 ANDA ANDA078492 NuCare Pharmaceuticals,Inc. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1640_5d01fde5-e4d0-6670-e053-2991aa0a5b15 68071-1640 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20140813 ANDA ANDA077137 NuCare Pharmaceuticals,Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 68071-1642_575e2630-eaad-8e56-e053-2a91aa0a9a35 68071-1642 HUMAN OTC DRUG Next Choice One Dose Levonorgestrel TABLET ORAL 20140512 ANDA ANDA200670 NuCare Pharmaceuticals,Inc. LEVONORGESTREL 1.5 mg/1 N 20181231 68071-1643_59284763-3934-f6da-e053-2991aa0a7996 68071-1643 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SOLUTION ORAL 20060214 ANDA ANDA040649 NuCare Pharmaceuticals,Inc. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68071-1646_54c236ce-69c3-06ef-e054-00144ff88e88 68071-1646 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 NuCare Pharmaceuticals,Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1647_51f3d155-36f5-4c40-e054-00144ff8d46c 68071-1647 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone OINTMENT TOPICAL 19980901 OTC MONOGRAPH NOT FINAL part348 NuCarePharmaceuticals, Inc. HYDROCORTISONE 1 g/100g N 20181231 68071-1648_518c0b9e-331b-0a48-e054-00144ff8d46c 68071-1648 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20071030 ANDA ANDA078341 NuCare Pharmaceuticals, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68071-1651_55e1f68a-836a-5c23-e054-00144ff88e88 68071-1651 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 19970214 ANDA ANDA064120 NuCare Pharmaceuticals,Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68071-1655_575bf24b-608e-7490-e053-2991aa0a1993 68071-1655 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19991027 ANDA ANDA064134 NuCare Pharmaceuticals,Inc. TOBRAMYCIN; DEXAMETHASONE 3; 1 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1657_54272dfb-99d0-6a45-e054-00144ff8d46c 68071-1657 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20080923 ANDA ANDA078930 NuCare Pharmaceuticals,Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1658_592cd7cb-bde7-906b-e053-2a91aa0a917d 68071-1658 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070813 ANDA ANDA078050 NuCare Pharmaceuticals,Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-1659_549bf887-1ef0-6a75-e054-00144ff8d46c 68071-1659 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20040422 ANDA ANDA076541 NuCare Pharmaceuticals,Inc. MIRTAZAPINE 30 mg/1 N 20181231 68071-1661_5d03ae66-79a9-349e-e053-2a91aa0a3ead 68071-1661 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201091 NuCare Pharamaceuticals,Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-1670_54d90668-5238-4330-e054-00144ff88e88 68071-1670 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20060609 NDA NDA020983 NuCare Pharmaceuticals,Inc. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68071-1672_5a1c5b04-b78d-c057-e053-2991aa0aa916 68071-1672 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 NuCare Pharmaceuticals,Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-1673_5745dd13-8e26-f87e-e053-2991aa0af01d 68071-1673 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride E-R CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 NuCare Pharmaceuticals,Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-1675_59a513b0-8f56-2fa6-e053-2991aa0a2b65 68071-1675 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 NuCare Pharmaceuticals,Inc. AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-1682_5a2d5052-95cf-d103-e053-2991aa0aa4be 68071-1682 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20100622 ANDA ANDA090568 NuCare Pharmaceuticals,Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 68071-1683_5e9762d8-cc50-9f18-e053-2991aa0a14bd 68071-1683 HUMAN PRESCRIPTION DRUG Latanoprost latanoprost SOLUTION/ DROPS OPHTHALMIC 20110322 ANDA ANDA201006 NuCare Pharmaceuticals,Inc. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 68071-1684_51c79544-9531-5863-e054-00144ff8d46c 68071-1684 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-1687_5a1b1f78-42f4-31ed-e053-2a91aa0a2e1e 68071-1687 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20140103 ANDA ANDA203814 NuCare Pharmaceuticals,Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 68071-1690_54c46aae-9be8-3334-e054-00144ff8d46c 68071-1690 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-1695_5a1a0e97-d6a3-817d-e053-2991aa0a3ff5 68071-1695 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160804 ANDA ANDA205519 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1709_570acb82-0c70-0b98-e054-00144ff8d46c 68071-1709 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 NuCare Pharmaceuticals,Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68071-1710_518c0b9e-33a0-0a48-e054-00144ff8d46c 68071-1710 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20071030 ANDA ANDA078341 NuCare Pharmaceuticals, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68071-1711_56456210-2db6-4f0d-e054-00144ff8d46c 68071-1711 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 NuCare Pharmaceuticals,Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1716_552c3286-f9c3-4e2c-e054-00144ff8d46c 68071-1716 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20040422 ANDA ANDA076541 NuCare Pharmaceuticals,Inc. MIRTAZAPINE 15 mg/1 N 20181231 68071-1720_61d1088e-b3c9-a1ce-e053-2a91aa0aee73 68071-1720 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 NuCare Pharmaceuticals,Inc. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 68071-1721_597e2b7e-50ed-1d2b-e053-2991aa0a7f47 68071-1721 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 NuCare Pharmaceuticals,Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1722_549c7037-9583-068b-e054-00144ff8d46c 68071-1722 HUMAN PRESCRIPTION DRUG PREDNISOLONE ACETATE prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 19970819 NDA AUTHORIZED GENERIC NDA017011 NuCare Pharmaceuticals,Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1729_56e698e9-74ea-5912-e054-00144ff8d46c 68071-1729 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 NuCare Pharmaceuticals,Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 68071-1733_592811f2-e232-6a58-e053-2991aa0a69a9 68071-1733 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20161013 ANDA ANDA077836 NuCare Pharmaceuticals,Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 68071-1734_56318d84-8d14-498f-e054-00144ff88e88 68071-1734 HUMAN PRESCRIPTION DRUG clotrimazole and betamethasone dipropionate clotrimazole and betamethasone dipropionate CREAM TOPICAL 20070103 ANDA ANDA076002 NuCare Pharmaceuticals,Inc. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1735_54c6543a-c97e-1a81-e054-00144ff8d46c 68071-1735 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20161001 ANDA ANDA076942 NuCare Pharmaceuticals,Inc. KETOCONAZOLE 20.5 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68071-1736_51cb7348-d45f-3838-e054-00144ff8d46c 68071-1736 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20070301 ANDA ANDA040702 NuCare Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-1740_570a9f0d-04fc-2922-e054-00144ff88e88 68071-1740 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 NuCare Pharmaceuticals,Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-1743_580f4bd4-63e4-a184-e053-2991aa0a3752 68071-1743 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 NuCare Pharmaceuticals,Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68071-1746_548b1b3f-2189-04ce-e054-00144ff8d46c 68071-1746 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 NuCare Pharmaceuticals,Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-1754_51f2ab70-075e-05e5-e054-00144ff8d46c 68071-1754 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20161001 ANDA ANDA073085 NuCare Pharmaceuticals,Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1760_5f8b3c58-eda0-84a2-e053-2a91aa0ac8cf 68071-1760 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 NuCare Pharmaceuticals,Inc. AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-1761_5c60cb1c-3bb0-3af2-e053-2a91aa0ae208 68071-1761 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065322 NuCare Pharmaceuticals,Inc. AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-1767_556834f5-ff81-7421-e054-00144ff88e88 68071-1767 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SOLUTION ORAL 20060426 ANDA ANDA040643 NuCare Pharmaceuticals,Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68071-1770_55c99902-3d4e-05e9-e054-00144ff8d46c 68071-1770 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 NuCare Pharmaceuticals,Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-1771_3b76067a-858a-0abb-e054-00144ff8d46c 68071-1771 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950217 ANDA ANDA074056 NuCare Pharmaceuticals, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-1773_54399c3c-2fda-327d-e054-00144ff8d46c 68071-1773 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 NuCare Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-1774_51c8ba6b-5bb7-2c14-e054-00144ff88e88 68071-1774 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 NuCare Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-1775_5786b8d9-3819-66a5-e053-2991aa0a7025 68071-1775 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 NuCare Pharmaceuticals,Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-1777_61d304eb-cf65-c5e6-e053-2a91aa0acd65 68071-1777 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 NuCare Pharmaceuticals,Inc. PREDNISONE 10 mg/1 N 20191231 68071-1778_5f228655-0992-7f3a-e053-2991aa0ab8c0 68071-1778 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19900930 ANDA ANDA060456 NuCare Pharmaceuticals,Inc. PENICILLIN V POTASSIUM 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-1780_55e1f68a-836c-5c23-e054-00144ff88e88 68071-1780 HUMAN OTC DRUG Biofreeze Professional Colorless MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part348 NuCare Pharmaceuticals,Inc. MENTHOL, UNSPECIFIED FORM 50 mg/mL N 20181231 68071-1783_6052fb87-9562-3050-e053-2991aa0a1f22 68071-1783 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 NuCare Pharmaceuticals,Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-1784_548ad9ce-cef8-63a2-e054-00144ff88e88 68071-1784 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide OINTMENT TOPICAL 20160513 ANDA ANDA205373 NuCare Pharmaceuticals,Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1785_55dd0863-730e-3a66-e054-00144ff8d46c 68071-1785 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR 20151030 ANDA ANDA074802 NuCare Pharmaceuticals,Inc. KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 68071-1786_60691443-f2b3-11fe-e053-2991aa0ae82f 68071-1786 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19721127 ANDA ANDA080817 NuCare Pharmaceuticals,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 68071-1787_5e208b85-7a46-57ec-e053-2991aa0a622c 68071-1787 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20060119 ANDA ANDA074802 NuCare Pharmaceuticals,Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 68071-1789_54c52e4d-53d0-64f2-e054-00144ff88e88 68071-1789 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20060619 ANDA ANDA065325 NuCare Pharmaceuticals,Inc. AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-1794_55a4dd22-9d9d-0541-e054-00144ff88e88 68071-1794 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 NuCare Pharmaceuticals,Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-1795_5488bca7-a56e-6ead-e054-00144ff8d46c 68071-1795 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 NuCare Pharmaceuticals,Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-1797_543abb68-c697-65e7-e054-00144ff8d46c 68071-1797 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 NuCare Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68071-1799_4adff0d5-c39d-5908-e054-00144ff8d46c 68071-1799 HUMAN PRESCRIPTION DRUG ERYTHROMYCIN ERYTHROMYCIN SOLUTION TOPICAL 19871023 ANDA ANDA062825 NuCare Pharmaceuticals, Inc. ERYTHROMYCIN 20 mg/mL Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-1803_56f8e191-ee0b-70f9-e054-00144ff8d46c 68071-1803 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20120401 ANDA ANDA088042 NuCare Pharmaceuticals,Inc. TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1806_51f3d155-3714-4c40-e054-00144ff8d46c 68071-1806 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19900930 ANDA ANDA060456 NuCare Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-1808_5fc2c901-5fc4-e0c8-e053-2991aa0a9428 68071-1808 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 NuCare Pharmaceuticals,Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-1811_549a6cf5-4fba-0ea1-e054-00144ff88e88 68071-1811 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 NuCare Pharmaceuticals,Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68071-1812_55a26c8f-19dc-4c96-e054-00144ff8d46c 68071-1812 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 NuCare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANIC ACID 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-1814_55f22080-de76-6db5-e054-00144ff8d46c 68071-1814 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 NuCare Pharmaceuticals,Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68071-1817_5b477a51-a459-203b-e053-2991aa0a43b6 68071-1817 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NuCare Pharmaceuticals,Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-1820_55a44735-6d6d-3012-e054-00144ff8d46c 68071-1820 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 19900930 ANDA ANDA060456 NuCare Pharmaceuticals,Inc. PENICILLIN V POTASSIUM 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-1825_59a76b0b-73a3-6b9e-e053-2991aa0abb43 68071-1825 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 NuCare Pharmaceuticals,Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-1827_566cbde3-9c83-1739-e054-00144ff8d46c 68071-1827 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 NuCare Pharmaceuticals,Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-1828_59068b37-d979-38ea-e053-2a91aa0a28c2 68071-1828 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 NuCare Pharmaceuticals,Inc. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-1829_59283950-c217-da1f-e053-2991aa0ac82a 68071-1829 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050509 ANDA ANDA065169 NuCare Pharmceuticals,Inc. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-1836_5f4eb389-e94b-dc97-e053-2a91aa0a0607 68071-1836 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 NuCare Pharmaceuticals,Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-1837_56e61bac-4a02-418e-e054-00144ff8d46c 68071-1837 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090801 ANDA ANDA077789 NuCare Pharmaceuticals,Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 68071-1841_638803d2-a173-486d-e053-2991aa0ab074 68071-1841 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 NuCare Pharmaceuticals,Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 68071-1842_61fb3780-7699-3eb9-e053-2a91aa0ad5d8 68071-1842 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20100524 ANDA ANDA077135 NuCare Pharmaceuticals,Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 68071-1844_575c4df3-e603-0def-e053-2a91aa0afa51 68071-1844 HUMAN OTC DRUG HYDROCORTISONE HYDROCORTISONE OINTMENT TOPICAL 19810101 OTC MONOGRAPH NOT FINAL part348 NuCare Pharmaceuticals,Inc. HYDROCORTISONE 5 mg/g N 20181231 68071-1856_5cdc6666-830f-b197-e053-2991aa0ae1c7 68071-1856 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070219 NuCare Pharmceuticals,Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-1863_59a0a4a6-e320-5766-e053-2a91aa0a66eb 68071-1863 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20110307 ANDA ANDA078423 NuCare Pharmaceuticals,Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68071-1864_58b63f70-9c89-9f79-e053-2a91aa0a328c 68071-1864 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20160615 ANDA ANDA080704 NuCare Pharmaceuticals,Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 68071-1866_553accf9-f63d-3b80-e054-00144ff88e88 68071-1866 HUMAN PRESCRIPTION DRUG DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20151201 ANDA ANDA206781 NuCare Pharmaceuticals,Inc. DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-1868_56422f93-0375-25f8-e054-00144ff8d46c 68071-1868 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20130902 ANDA ANDA078155 NuCare Pharmaceuticals,Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1869_5a2da8d4-2f7e-d6dc-e053-2a91aa0ad017 68071-1869 HUMAN OTC DRUG Sore Throat Cherry Phenol SPRAY ORAL 20140930 OTC MONOGRAPH NOT FINAL part356 NuCare Pharmaceuticals,Inc. PHENOL 1.4 g/100mL N 20181231 68071-1870_59cdc070-b4a3-1502-e053-2a91aa0a34fa 68071-1870 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 NuCare Pharmaceuticals,Inc. MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68071-1871_55f21788-aa8e-1510-e054-00144ff88e88 68071-1871 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20161001 OTC MONOGRAPH FINAL part349 NuCare Pharmaceuticals,Inc. WATER 99.05 mL/100mL N 20181231 68071-1873_552b5106-8d3a-199d-e054-00144ff88e88 68071-1873 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065153 NuCare Pharmaceuticals,Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-1874_3e49f7ce-c741-364b-e054-00144ff88e88 68071-1874 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20150713 ANDA ANDA200958 NuCare Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68071-1875_4be6c9ae-15da-6892-e054-00144ff88e88 68071-1875 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 19900930 ANDA ANDA071655 NuCare Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68071-1876_4040db14-7510-6d20-e054-00144ff8d46c 68071-1876 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 NuCare Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68071-1877_403035b1-2f30-2b6e-e054-00144ff88e88 68071-1877 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20160516 ANDA ANDA091133 NuCare Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68071-1878_4b7d3378-86dc-0a5f-e054-00144ff8d46c 68071-1878 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20110720 ANDA ANDA077179 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-1879_4041d4de-40fe-292e-e054-00144ff8d46c 68071-1879 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20151222 ANDA ANDA206530 NuCare Pharmaceuticals, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68071-1881_4bcd68ad-da0b-18db-e054-00144ff8d46c 68071-1881 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 19960725 ANDA ANDA040120 NuCare Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68071-1882_4b7cbe44-98d1-1eb3-e054-00144ff88e88 68071-1882 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET ORAL 20130419 ANDA ANDA203145 NuCare Pharmaceuticals, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-1883_552c58cd-5b92-34bf-e054-00144ff88e88 68071-1883 HUMAN OTC DRUG Prevacid 24 HR Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20091012 NDA NDA022327 NuCare Pharmaceuticals,Inc. LANSOPRAZOLE 15 mg/1 N 20181231 68071-1884_504933ad-e3eb-71f0-e054-00144ff88e88 68071-1884 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 NuCare Pharmaceuticals, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-1885_4be31c8e-8237-11d2-e054-00144ff8d46c 68071-1885 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160804 ANDA ANDA205519 NuCare Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1886_63751e77-51cf-37f0-e053-2991aa0a30e3 68071-1886 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160804 ANDA ANDA205519 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68071-1887_4be6ce23-e7b2-510e-e054-00144ff8d46c 68071-1887 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 NuCare Pharmaceuticals, Inc ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 68071-1888_4b7dd8cb-fde6-4675-e054-00144ff88e88 68071-1888 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 NuCare Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-1889_4fbed5ca-14c5-61f7-e054-00144ff8d46c 68071-1889 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150422 ANDA ANDA202824 NuCare Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68071-1891_5188a160-120a-58f5-e054-00144ff88e88 68071-1891 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 NuCare Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68071-1892_40fb8288-e06d-3833-e054-00144ff88e88 68071-1892 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20130301 ANDA ANDA201504 NuCare Pharmaceuticals, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 68071-1893_4b82425c-dfc1-61db-e054-00144ff88e88 68071-1893 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 NuCare Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68071-1894_4f1f76fe-816d-384a-e054-00144ff88e88 68071-1894 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 NuCare Pharmaceuticals, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-1895_4be6c9ae-1538-6892-e054-00144ff88e88 68071-1895 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 NuCare Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 68071-1896_4bce3ec1-d121-62ba-e054-00144ff8d46c 68071-1896 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20150115 ANDA ANDA202039 NuCare Pharmaceuticals, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 68071-1897_4bcfa9a5-f81e-5d58-e054-00144ff88e88 68071-1897 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 NuCare Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68071-1898_44593437-770b-4b68-e054-00144ff8d46c 68071-1898 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 NuCare Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1899_4b7dbff8-c9af-1d20-e054-00144ff8d46c 68071-1899 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20120725 ANDA ANDA065489 NuCare Pharmaceuticals, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68071-1900_4912cd69-64b7-31ff-e054-00144ff8d46c 68071-1900 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 NuCare Pharmaceuticals, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-1901_4922d05a-73ea-6362-e054-00144ff8d46c 68071-1901 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 NuCare Pharmaceuticals, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68071-1902_4911f343-6835-71b0-e054-00144ff8d46c 68071-1902 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-1903_490ee468-4aeb-58ec-e054-00144ff8d46c 68071-1903 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-1904_4925fbf0-5a79-230d-e054-00144ff88e88 68071-1904 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 NuCare Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-1905_49123659-5497-0fb5-e054-00144ff8d46c 68071-1905 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-1906_579836d8-64ee-de2d-e053-2a91aa0a8392 68071-1906 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 NuCare Pharmaceuticals,Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-1907_4937b075-0ce2-38e8-e054-00144ff8d46c 68071-1907 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 NuCare Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-1908_49869e32-8eb0-5e29-e054-00144ff8d46c 68071-1908 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 NuCare Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68071-1909_4911f343-68e5-71b0-e054-00144ff8d46c 68071-1909 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 NuCare Pharmaceuticals, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 68071-1910_44a97090-5106-593a-e054-00144ff88e88 68071-1910 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 NuCare Pharmaceuticals, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-1912_48c133d5-0a79-424b-e054-00144ff8d46c 68071-1912 HUMAN PRESCRIPTION DRUG losartan potassium losartan potassium TABLET, FILM COATED ORAL 20110601 ANDA ANDA091497 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-1913_44a8eed3-5a11-4a0c-e054-00144ff88e88 68071-1913 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA077118 NuCare Pharmaceuticals, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-1914_48fbaf47-d471-3189-e054-00144ff8d46c 68071-1914 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 NuCare Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68071-1915_48c17b1e-925e-4ec1-e054-00144ff8d46c 68071-1915 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 NuCare Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1916_4458c120-3065-2f39-e054-00144ff8d46c 68071-1916 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-1917_491201a8-ada6-60c4-e054-00144ff88e88 68071-1917 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20061023 ANDA ANDA076939 NuCare Pharmaceuticals, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1918_4b7d32de-7866-0a64-e054-00144ff8d46c 68071-1918 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-1919_4911f343-68e7-71b0-e054-00144ff8d46c 68071-1919 HUMAN PRESCRIPTION DRUG MELOXICAM meloxicam TABLET ORAL 20060719 ANDA ANDA077929 NuCare Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-1921_44a95264-6287-0c77-e054-00144ff8d46c 68071-1921 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 NuCare Pharmaceuticals, Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-1922_44aa10b7-538e-73c5-e054-00144ff88e88 68071-1922 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 NuCare Pharmaceuticals, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-1923_44acce8d-18b6-4e73-e054-00144ff88e88 68071-1923 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100415 ANDA ANDA077298 NuCare Pharmaceuticals, Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-1924_4b7c6442-a13f-464f-e054-00144ff8d46c 68071-1924 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-1925_48c17b1e-91ee-4ec1-e054-00144ff8d46c 68071-1925 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 NuCare Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68071-1926_490ecfb6-7630-2c1c-e054-00144ff8d46c 68071-1926 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 NuCare Pharmaceuticals, Inc. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68071-1927_4939edbb-3429-3f6f-e054-00144ff88e88 68071-1927 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 NuCare Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-1928_48fdd4c2-33cc-237c-e054-00144ff88e88 68071-1928 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 ANDA ANDA090492 NuCare Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68071-1929_4923b99c-733f-24e6-e054-00144ff8d46c 68071-1929 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19950103 ANDA ANDA074342 NuCare Pharmaceuticals, Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-1931_490fcf48-5478-109d-e054-00144ff8d46c 68071-1931 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 NuCare Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-1932_4921dcac-ba3e-39bb-e054-00144ff8d46c 68071-1932 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 NuCare Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 68071-1933_4925fbf0-5b09-230d-e054-00144ff88e88 68071-1933 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20040818 ANDA ANDA076368 NuCare Pharmaceuticals, Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68071-1934_49245aec-9a10-459e-e054-00144ff8d46c 68071-1934 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 NuCare Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68071-1935_48fc5ddd-b0bd-1c5a-e054-00144ff8d46c 68071-1935 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 NuCare Pharmaceutical, Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68071-1936_48fd2413-8a2f-423a-e054-00144ff8d46c 68071-1936 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NuCare Pharmaceuticals, Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-1937_492364fe-95bc-48c6-e054-00144ff88e88 68071-1937 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20150402 ANDA ANDA065062 NuCare Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68071-1938_48fe36bc-07a2-7094-e054-00144ff8d46c 68071-1938 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 NuCare Pharmaceuticals, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-1939_49123659-541f-0fb5-e054-00144ff8d46c 68071-1939 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 NuCare Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68071-1940_4b7d3378-86f9-0a5f-e054-00144ff8d46c 68071-1940 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 NuCare Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68071-1941_4937f5b6-5d02-4b74-e054-00144ff8d46c 68071-1941 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 NuCare Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68071-1942_490f2701-bfa6-07ec-e054-00144ff88e88 68071-1942 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 NuCare Pharmaceuticals, Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-1944_4937f5b6-5ca9-4b74-e054-00144ff8d46c 68071-1944 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150702 ANDA ANDA076467 NuCare Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-1945_4925a3ad-63be-108a-e054-00144ff8d46c 68071-1945 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 NuCare Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-1946_48c31e84-2af2-2056-e054-00144ff88e88 68071-1946 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 NuCare Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1947_48c239dd-58e1-6ad5-e054-00144ff8d46c 68071-1947 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-1948_48fc8507-20f2-6f8a-e054-00144ff88e88 68071-1948 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA076048 NuCare Pharmaceuticals, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-1951_5b4e2c4e-4e57-7794-e053-2a91aa0ab4e6 68071-1951 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20160615 ANDA ANDA080704 NuCare Pharmaceuticals, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 68071-1952_48ff7a43-f51a-2787-e054-00144ff8d46c 68071-1952 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-1953_48fae1ec-1581-3cfb-e054-00144ff88e88 68071-1953 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 NuCare Pharmaceuticals, Inc. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68071-1954_49136853-0764-451f-e054-00144ff8d46c 68071-1954 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 NuCare Pharmaceuticals, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68071-1956_490f7bc0-0fda-746a-e054-00144ff8d46c 68071-1956 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-1958_48ff54c9-bb90-353b-e054-00144ff8d46c 68071-1958 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-1959_63607368-e427-4d0e-e053-2a91aa0a65da 68071-1959 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 19971031 ANDA ANDA075079 NuCare Pharmaceuticals,Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 68071-1960_490ecc1d-df61-7489-e054-00144ff88e88 68071-1960 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 NuCare Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-1961_492392c0-6830-2131-e054-00144ff8d46c 68071-1961 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20150325 ANDA ANDA078722 NuCare Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68071-1962_4937fce2-991a-033d-e054-00144ff88e88 68071-1962 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 NuCare Pharmaceuticals, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68071-1963_4fbeb025-6e41-1f52-e054-00144ff88e88 68071-1963 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 NuCare Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68071-1964_4913192a-7365-3f19-e054-00144ff8d46c 68071-1964 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 NuCare Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 68071-1965_4937a08d-3ace-6d79-e054-00144ff88e88 68071-1965 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 NuCare Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1966_493a348f-4f20-4272-e054-00144ff8d46c 68071-1966 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 NuCare Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-1967_49118e20-a73c-52a5-e054-00144ff88e88 68071-1967 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 NuCare Pharmaceuticals, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-1968_4937f5b6-5ccf-4b74-e054-00144ff8d46c 68071-1968 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 NuCare Pharmaceutical, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-1970_493b07f2-f13a-61ef-e054-00144ff88e88 68071-1970 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20160722 ANDA ANDA077534 NuCare Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-1971_490f109f-30cc-0790-e054-00144ff88e88 68071-1971 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 NuCare Pharmaceuticals, Inc. TOPIRAMATE 25 meq/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-1972_49123659-5488-0fb5-e054-00144ff8d46c 68071-1972 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 NuCare Pharmaceuticals, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68071-1973_4925f194-c8e0-242c-e054-00144ff88e88 68071-1973 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 NuCare Pharmaceuticals, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1974_492364fe-95ee-48c6-e054-00144ff88e88 68071-1974 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-1975_48ff54c9-bb1c-353b-e054-00144ff8d46c 68071-1975 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-1976_492344eb-829e-4639-e054-00144ff88e88 68071-1976 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 NuCare Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-1977_62fe2e98-9fe4-2d68-e053-2991aa0ae981 68071-1977 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 20070802 ANDA ANDA077557 NuCare Pharmaceuticals,Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 68071-1978_49128bac-1165-204b-e054-00144ff8d46c 68071-1978 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150701 NDA NDA022370 NuCare Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68071-1979_4fbc055d-ea8e-5ac0-e054-00144ff8d46c 68071-1979 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20151118 ANDA ANDA203963 NuCare Pharmaceuticals, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 68071-1980_4926f00c-ee1a-3e10-e054-00144ff88e88 68071-1980 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-1981_48fe6f49-c0fb-0430-e054-00144ff8d46c 68071-1981 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 19950829 ANDA ANDA064082 NuCare Pharmaceuticals, Inc. AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-1983_57eb13d0-35fc-eff8-e053-2991aa0acfa6 68071-1983 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 NuCare Pharmaceuticals,Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68071-1984_492387c0-25b3-4fcc-e054-00144ff88e88 68071-1984 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 NuCare Phamaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68071-1985_4913b5e2-7aeb-2207-e054-00144ff88e88 68071-1985 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 NuCare Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-1986_4443a885-c2e5-070a-e054-00144ff88e88 68071-1986 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-1987_4937b075-0cdd-38e8-e054-00144ff8d46c 68071-1987 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 NuCare Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-1988_49136853-0779-451f-e054-00144ff8d46c 68071-1988 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20071227 ANDA ANDA078317 NuCare Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 68071-1989_48fbb654-bba5-73d9-e054-00144ff8d46c 68071-1989 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-1990_492387c0-25b4-4fcc-e054-00144ff88e88 68071-1990 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 NuCare Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-1991_490f2701-bf79-07ec-e054-00144ff88e88 68071-1991 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20151001 ANDA ANDA091220 NuCare Pharmaceuticals, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-1992_48fbb654-bb62-73d9-e054-00144ff8d46c 68071-1992 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 19860723 ANDA ANDA089424 NuCare Pharmaceuticals, Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68071-1993_4925f194-c925-242c-e054-00144ff88e88 68071-1993 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 NuCare Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-1994_630221ef-714f-6996-e053-2991aa0a586f 68071-1994 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 NuCare Pharmaceuticals,Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68071-1995_44449925-3bfe-0d04-e054-00144ff8d46c 68071-1995 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 NuCare Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-1996_4fbc055d-ea8b-5ac0-e054-00144ff8d46c 68071-1996 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA072750 NuCare Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 68071-1997_44593437-7703-4b68-e054-00144ff8d46c 68071-1997 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076410 NuCare Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 68071-1998_6249fa66-0947-a6e4-e053-2991aa0a5b5e 68071-1998 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 NuCare Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 68071-1999_445a925a-57e3-17f3-e054-00144ff8d46c 68071-1999 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 NuCare Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68071-2012_3b651fb0-e0d3-1bec-e054-00144ff8d46c 68071-2012 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 NuCare Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68071-2013_46df076d-4e4b-6faa-e054-00144ff8d46c 68071-2013 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20090301 ANDA ANDA078503 NuCare Pharmaceuticals, Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68071-2014_46df076d-4e39-6faa-e054-00144ff8d46c 68071-2014 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 NuCare Pharmaceuticals, Inc. SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 68071-2018_46df076d-4e99-6faa-e054-00144ff8d46c 68071-2018 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 NuCare Pharmaceuticals, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-2019_3b64e7dd-d0cf-4be0-e054-00144ff88e88 68071-2019 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 NuCare Pharmaceuticals, Inc. BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68071-2021_48aa7ef3-9f86-2a08-e054-00144ff88e88 68071-2021 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20151123 ANDA ANDA204019 NuCare Pharmaceuticals, Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68071-2033_46dff4c0-9a69-20f9-e054-00144ff8d46c 68071-2033 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-2035_63264765-9ac2-286c-e053-2a91aa0ad0a9 68071-2035 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130319 ANDA ANDA202389 NuCare Pharmaceuticals,Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68071-2036_46e027f8-ce10-3471-e054-00144ff88e88 68071-2036 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-2037_46e027f8-ce6a-3471-e054-00144ff88e88 68071-2037 HUMAN PRESCRIPTION DRUG Chlorthalidone Chlorthalidone TABLET ORAL 20160212 ANDA ANDA089286 NuCare Pharmaceuticals, Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 68071-2038_63262a47-d38d-ff7f-e053-2a91aa0af278 68071-2038 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 NuCare Pharmaceuticals,Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20191231 68071-2042_481f8cd9-8791-017f-e054-00144ff8d46c 68071-2042 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160209 NDA AUTHORIZED GENERIC NDA021656 NuCare Pharmaceuticals, Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68071-2051_63260211-f1e7-b070-e053-2a91aa0a3417 68071-2051 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 NuCare Pharmaceuticals,Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68071-2052_46e0afbd-4b3e-4b8b-e054-00144ff88e88 68071-2052 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20120424 ANDA ANDA077027 NuCare Pharmaceuticals, Inc. CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 68071-2055_3b61d1b0-c69a-67a8-e054-00144ff88e88 68071-2055 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 NuCare Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68071-2059_46dfe5ef-4978-34a7-e054-00144ff88e88 68071-2059 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 NuCare Pharmaceuticals, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-2065_46dff4c0-9a2d-20f9-e054-00144ff8d46c 68071-2065 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20041123 ANDA ANDA077021 NuCare Pharmaceuticals,Inc. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 68071-2072_46dff4c0-9a6d-20f9-e054-00144ff8d46c 68071-2072 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20140103 ANDA ANDA203814 NuCare Pharmaceuticals, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 68071-2082_46e03120-8383-382a-e054-00144ff8d46c 68071-2082 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071221 ANDA ANDA077056 NuCare Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68071-2088_46e027f8-ce6d-3471-e054-00144ff88e88 68071-2088 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 NuCare Pharmaceuticals,Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-2092_62edd9c2-4534-af52-e053-2a91aa0aacab 68071-2092 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 NuCare Pharmaceuticals,Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68071-2099_46e00ca4-1725-316f-e054-00144ff88e88 68071-2099 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20100524 ANDA ANDA077135 NuCare Pharmaceuticals,Inc. VALACYCLOVIR HYDROCHLORIDE 1000 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68071-2110_46e03120-8386-382a-e054-00144ff8d46c 68071-2110 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20100524 ANDA ANDA077135 NuCare Pharmaceuticals,Inc. VALACYCLOVIR HYDROCHLORIDE 1000 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68071-2112_46e06df0-654e-43cc-e054-00144ff8d46c 68071-2112 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20040802 NDA NDA021752 NuCare Pharmaceuticals,Inc. EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68071-2113_46ef8e2e-ae64-6a3c-e054-00144ff8d46c 68071-2113 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20071012 NDA NDA022145 NuCare Pharmaceuticals,Inc. RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] N 20181231 68071-2115_48209b78-13b8-09b6-e054-00144ff88e88 68071-2115 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160209 NDA AUTHORIZED GENERIC NDA021656 NuCare Pharmaceuticals, Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68071-2118_4bce125d-2b10-5598-e054-00144ff8d46c 68071-2118 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 NuCare Pharmaceuticals, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-2119_46ef7319-deee-6122-e054-00144ff8d46c 68071-2119 HUMAN PRESCRIPTION DRUG Valsartan and hydrochlorothiazide Valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA091519 NuCare Pharmaceuticals, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-2123_46f10483-af5e-46af-e054-00144ff8d46c 68071-2123 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20120927 ANDA ANDA202414 NuCare Pharmaceuticals, Inc. IRBESARTAN; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-2131_540ee876-78f7-1792-e054-00144ff88e88 68071-2131 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 NuCare Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE 6.25; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-2133_46f11a74-eb85-4ef8-e054-00144ff8d46c 68071-2133 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 NuCare Pharmaceuticals, Inc. LIOTHYRONINE SODIUM 50 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 68071-2134_46f12f28-b677-2b60-e054-00144ff88e88 68071-2134 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20151001 ANDA ANDA200900 NuCare Pharmaceuticals,Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 68071-2135_46f1a3d0-566f-69f0-e054-00144ff8d46c 68071-2135 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 NuCare Pharmaceuticals, Inc. FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68071-2138_46eea435-cd2c-400f-e054-00144ff8d46c 68071-2138 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 NuCare Pharmaceuticals, Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20191231 68071-2139_63616317-b9a5-5a69-e053-2991aa0a65f9 68071-2139 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA078627 NuCare Pharmaceuticals,Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68071-2142_47550efb-8a0d-0ab5-e054-00144ff88e88 68071-2142 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 NuCare Pharmaceuticals, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-2145_46ef7319-deb6-6122-e054-00144ff8d46c 68071-2145 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20100515 ANDA ANDA085472 NuCare Pharmaceuticals, Inc. CHLORDIAZEPOXIDE HYDROCHLORIDE 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-2147_46ef7319-def0-6122-e054-00144ff8d46c 68071-2147 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 NuCare Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-2153_46f0a687-79d3-1d0a-e054-00144ff88e88 68071-2153 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20140415 ANDA ANDA091153 NuCare Pharmaceuticals, Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 68071-2156_46f0de78-ef7b-43c0-e054-00144ff8d46c 68071-2156 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20130923 ANDA ANDA075274 NuCare Pharmaceuticls, Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 68071-2162_4bce3ec1-d11f-62ba-e054-00144ff8d46c 68071-2162 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 NuCare Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-2164_601841d7-b26d-70c6-e053-2a91aa0a41c6 68071-2164 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 NuCare Pharmaceuticals,Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-2166_46f1a3d0-5671-69f0-e054-00144ff8d46c 68071-2166 HUMAN PRESCRIPTION DRUG Clomiphene Citrate Clomiphene Citrate TABLET ORAL 19990830 ANDA ANDA075528 NuCare Pharmaceuticals, Inc. CLOMIPHENE CITRATE 50 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 68071-2169_46f1e0ac-d67c-4419-e054-00144ff88e88 68071-2169 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 NuCare Pharmaceuticals, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-2170_46f1f990-7dc3-027b-e054-00144ff8d46c 68071-2170 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 NuCare Pharmaceuticals, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 68071-2171_46f1e161-bedd-44d7-e054-00144ff88e88 68071-2171 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride Diethylpropion Hydrochloride TABLET ORAL 20110718 ANDA ANDA200177 NuCare Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68071-2173_504b36fb-83bd-26e3-e054-00144ff8d46c 68071-2173 HUMAN PRESCRIPTION DRUG Rabeprazole sodium Rabeprazole sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA202376 NuCare Pharmaceuticals, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68071-2174_4b6b2447-0162-378d-e054-00144ff8d46c 68071-2174 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET, ORALLY DISINTEGRATING ORAL 20090921 UNAPPROVED DRUG OTHER NuCare Pharmaceuticals, Inc. HYOSCYAMINE SULFATE .125 mg/1 N 20181231 68071-2175_43a33a55-a889-6d06-e054-00144ff8d46c 68071-2175 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 NuCare Pharmaceuticals, Inc. MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68071-2176_4bce3ec1-d123-62ba-e054-00144ff8d46c 68071-2176 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 NuCare Pharmaceuticals, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 68071-2177_43a33a55-a8ca-6d06-e054-00144ff8d46c 68071-2177 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-2179_43a5ca8a-8491-70cc-e054-00144ff88e88 68071-2179 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 19870904 ANDA ANDA070925 NuCare Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68071-2180_43a63143-114c-2640-e054-00144ff8d46c 68071-2180 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 NuCare Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-2181_43c9d391-6581-02c6-e054-00144ff8d46c 68071-2181 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150702 ANDA ANDA076467 NuCare Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-2184_43ca706a-27a0-2f93-e054-00144ff88e88 68071-2184 HUMAN PRESCRIPTION DRUG MELOXICAM meloxicam TABLET ORAL 20060719 ANDA ANDA077929 NuCare Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-2186_4391cdf9-63a8-1eae-e054-00144ff8d46c 68071-2186 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 NuCare Pharmaceuticals, Inc. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 68071-2188_4be6e524-6fcc-6eb8-e054-00144ff88e88 68071-2188 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20150601 ANDA ANDA205085 NuCare Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68071-2189_4b6b2ce1-e34a-3921-e054-00144ff8d46c 68071-2189 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 19950830 ANDA ANDA074388 NuCare Pharmaceuticals, Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-2190_5188871d-b5ba-4543-e054-00144ff8d46c 68071-2190 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 NuCare Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68071-2191_4bceb540-5a03-0167-e054-00144ff8d46c 68071-2191 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 NuCare Pharmaceuticals, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-2192_4bcdf2c6-dc1e-558f-e054-00144ff8d46c 68071-2192 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090702 ANDA ANDA079095 NuCare Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68071-2193_4b41b503-7120-2ac5-e054-00144ff8d46c 68071-2193 HUMAN OTC DRUG Rugby Travel Sickness Meclizine HCl, 25 mg Each (Antiemetic) Meclizine HCl TABLET, CHEWABLE ORAL 20140819 OTC MONOGRAPH FINAL part336 NuCare Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 68071-2194_445b6d9f-4fdf-420c-e054-00144ff8d46c 68071-2194 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20061023 ANDA ANDA076939 NuCare Pharmaceuticals, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-2195_4be63659-96db-2fac-e054-00144ff8d46c 68071-2195 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20071219 ANDA ANDA077056 NuCare Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68071-2196_4b82955d-8118-3c11-e054-00144ff8d46c 68071-2196 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 NuCare Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68071-2197_4fbf72e0-c7e8-0a50-e054-00144ff8d46c 68071-2197 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 NuCare Pharmaceuticals,Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68071-2198_4f45c818-b325-6ca6-e054-00144ff8d46c 68071-2198 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 NuCare Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-2199_4be616c4-1b9b-5654-e054-00144ff88e88 68071-2199 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 NuCarePharmaceuticals, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-3000_549c56d2-ef5e-4946-e054-00144ff88e88 68071-3000 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 NuCare Pharmaceuticals,Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-3001_4be6e524-705b-6eb8-e054-00144ff88e88 68071-3001 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20051201 ANDA ANDA077241 NuCare Pharmaceuticals, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68071-3002_4fbbc5b6-7aa9-34e5-e054-00144ff88e88 68071-3002 HUMAN OTC DRUG Rugby Meclizine HCl, 12.5 mg Each Antiemetic Meclizine HCl TABLET ORAL 20140307 OTC MONOGRAPH FINAL part336 NuCare Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 68071-3003_4b7cdb61-3504-13db-e054-00144ff88e88 68071-3003 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-3005_4b41b503-7135-2ac5-e054-00144ff8d46c 68071-3005 HUMAN OTC DRUG Meclizine HCl 25 mg Meclizine Hydrochloride TABLET, CHEWABLE ORAL 20151015 OTC MONOGRAPH FINAL part336 NuCare Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 68071-3006_4be7a143-def8-0f39-e054-00144ff88e88 68071-3006 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065153 NuCare Pharmaceuticals, Inc.. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-3008_4fbf31a1-037c-31a2-e054-00144ff88e88 68071-3008 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20030301 ANDA ANDA076194 NuCarePharmaceuticals, Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-3009_4a53a156-9ba6-5403-e054-00144ff8d46c 68071-3009 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 NuCare Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-3010_4a66b854-4dc2-3746-e054-00144ff8d46c 68071-3010 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 NuCare Pharmaceuticals, Inc. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-3011_4addfd06-9ba8-68f5-e054-00144ff8d46c 68071-3011 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20140114 NDA AUTHORIZED GENERIC NDA020405 NuCare Pharmaceuticals, Inc. DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 68071-3012_4a656f7b-ba41-6e15-e054-00144ff8d46c 68071-3012 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 NuCare Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-3013_4ab7ad0e-a394-1d9f-e054-00144ff8d46c 68071-3013 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 NuCare Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68071-3014_4ab5378e-cce8-1f64-e054-00144ff8d46c 68071-3014 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-3015_4add1b93-78f7-41d1-e054-00144ff8d46c 68071-3015 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE ORAL 20110603 ANDA ANDA200270 NuCarePharmaceuticals, Inc. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68071-3018_49db3bce-00c3-32a0-e054-00144ff8d46c 68071-3018 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150505 ANDA ANDA040616 NuCare Pharmaceuticals, Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 68071-3019_49dc2d0c-e3b7-232b-e054-00144ff88e88 68071-3019 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130823 ANDA ANDA202366 NuCare Pharmaceuticals, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68071-3020_59292243-386c-5ab4-e053-2991aa0a5b96 68071-3020 HUMAN OTC DRUG ROBAFEN COUGH FORMULA Guaifenesin SYRUP ORAL 20120815 OTC MONOGRAPH FINAL part341 NuCare Pharmceuticals,Inc. GUAIFENESIN 100 mg/5mL N 20181231 68071-3021_4a518014-2a40-6285-e054-00144ff8d46c 68071-3021 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA NDA021342 NuCare Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68071-3023_4ab651d4-61b1-51c3-e054-00144ff8d46c 68071-3023 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 NuCare Pharmaceuticals, Inc.. BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68071-3024_4a51cad8-ff11-4312-e054-00144ff88e88 68071-3024 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20150714 ANDA ANDA202112 NuCare Pharmaceuticals, Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-3026_4abaad56-e4e6-07fc-e054-00144ff88e88 68071-3026 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 NuCare Pharmaceuticals, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68071-3028_4ab6f935-e087-6c1f-e054-00144ff8d46c 68071-3028 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 NuCare Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-3029_49dc76d1-2628-0021-e054-00144ff8d46c 68071-3029 HUMAN PRESCRIPTION DRUG naproxen naproxen TABLET ORAL 20160705 ANDA ANDA091305 NuCare Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3031_49dcda70-98b4-07a1-e054-00144ff8d46c 68071-3031 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 NuCare Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 68071-3032_49db4bcd-8af5-048d-e054-00144ff88e88 68071-3032 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20140704 ANDA ANDA065418 NuCare Pharmaceuticals, Inc. CEFDINIR MONOHYDRATE 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-3033_49dcde42-9411-0dd7-e054-00144ff8d46c 68071-3033 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20060822 ANDA ANDA076817 NuCare Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68071-3034_49db4bcd-8aaf-048d-e054-00144ff88e88 68071-3034 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20100406 ANDA ANDA077289 NuCare Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3036_49dcda70-98bc-07a1-e054-00144ff8d46c 68071-3036 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 NuCare Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-3037_49db4bcd-8b5b-048d-e054-00144ff88e88 68071-3037 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20100524 ANDA ANDA077135 NuCare Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68071-3038_49db4bc2-2cf6-3466-e054-00144ff8d46c 68071-3038 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE TABLET, DELAYED RELEASE ORAL 20140910 ANDA ANDA202882 NuCare Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68071-3039_4ab84b42-8101-28e5-e054-00144ff8d46c 68071-3039 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 NuCare Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68071-3040_4a662f00-3e8e-11ba-e054-00144ff8d46c 68071-3040 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate CAPSULE, EXTENDED RELEASE ORAL 19770906 NDA NDA018074 NuCare Pharmaceuticals, Inc. PHENDIMETRAZINE TARTRATE 105 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 68071-3041_4a28ea7c-8e36-2406-e054-00144ff88e88 68071-3041 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19910731 ANDA ANDA063083 NuCare Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68071-3042_4a67f0d0-7858-433b-e054-00144ff88e88 68071-3042 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 NuCare Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3044_4a668406-d2fd-13c9-e054-00144ff88e88 68071-3044 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20121015 ANDA ANDA090460 NuCare Pharmaceuticals, Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68071-3045_4a404b77-c3bc-5775-e054-00144ff8d46c 68071-3045 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20050812 ANDA ANDA065243 NuCare Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68071-3046_647f8236-af4a-684d-e053-2991aa0adb1f 68071-3046 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140403 ANDA ANDA075350 NuCare Pharmaceuticals,Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 68071-3047_4aa20f8a-a419-3e28-e054-00144ff8d46c 68071-3047 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 NuCare Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3048_4ab5378e-ccf5-1f64-e054-00144ff8d46c 68071-3048 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 NuCarePharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 68071-3049_4a67b04d-4b46-5fe6-e054-00144ff8d46c 68071-3049 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 NuCare Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-3050_49dbbe82-11f5-4c34-e054-00144ff8d46c 68071-3050 HUMAN OTC DRUG Extra Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 68071-3051_4ab7ad0e-a303-1d9f-e054-00144ff8d46c 68071-3051 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 NuCare Pharmaceuticals, Inc. LEVOFLOXACIN 250 mg/1 N 20181231 68071-3054_4a6403ad-fa53-2b4a-e054-00144ff8d46c 68071-3054 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070801 ANDA ANDA078314 NuCare Pharmaceuticals, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3059_4ab99175-62df-0584-e054-00144ff8d46c 68071-3059 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 NuCarePharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 68071-3061_4ab96cec-3621-68bd-e054-00144ff88e88 68071-3061 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170105 ANDA ANDA202800 NuCare Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 68071-3062_4a66f9c1-2897-23a5-e054-00144ff88e88 68071-3062 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 19970819 ANDA ANDA085588 NuCare Pharmaceuticals, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 68071-3063_4a64c7f3-b305-4e5e-e054-00144ff8d46c 68071-3063 HUMAN OTC DRUG Rugby Meclizine HCl, 12.5 mg Each Antiemetic Meclizine HCl TABLET ORAL 20140307 OTC MONOGRAPH FINAL part336 NuCare Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 68071-3064_6314e49c-8716-2f01-e053-2a91aa0ab2a5 68071-3064 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 NuCare Pharmaceuticals,Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 68071-3065_4ab91ea4-3dcb-5fd3-e054-00144ff88e88 68071-3065 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 19920801 ANDA ANDA073665 NuCare Pharmaceuticals, Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 68071-3066_4a643dcd-c15e-34a4-e054-00144ff8d46c 68071-3066 HUMAN PRESCRIPTION DRUG naproxen naproxen TABLET ORAL 20160705 ANDA ANDA091305 NuCare Pharmaceuticals, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3067_4ab9d10e-8890-10cb-e054-00144ff8d46c 68071-3067 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 19851224 NDA AUTHORIZED GENERIC NDA018998 NuCare Pharmaceuticals, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-3068_4a512cab-1ad2-5466-e054-00144ff8d46c 68071-3068 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 NuCare Pharmaceuticals, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-3069_4a645652-ae20-3811-e054-00144ff8d46c 68071-3069 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20130321 ANDA ANDA202389 NuCare Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3070_4aa55bbb-085d-724b-e054-00144ff8d46c 68071-3070 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150609 ANDA ANDA075994 NuCare Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-3071_4b6e5bb2-7a94-5311-e054-00144ff8d46c 68071-3071 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 NuCare Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3072_4ab5378e-cd20-1f64-e054-00144ff8d46c 68071-3072 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 NuCare Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68071-3073_4ab55e9e-77bb-2189-e054-00144ff8d46c 68071-3073 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20151019 ANDA ANDA040616 NuCare Pharmaceuticals, Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 68071-3074_4a64b86b-49f5-4f7a-e054-00144ff88e88 68071-3074 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20160301 ANDA ANDA091239 NuCare Pharmaceuticals, Inc. IBUPROFEN 200 mg/1 N 20181231 68071-3076_4ab4c460-f4d5-0b29-e054-00144ff8d46c 68071-3076 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 NuCare Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68071-3077_4aa166fb-f673-25ed-e054-00144ff88e88 68071-3077 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET ORAL 20130419 ANDA ANDA203145 NuCare Pharmaceuticals, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-3078_4ab55e9e-7802-2189-e054-00144ff8d46c 68071-3078 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 NuCare Pharmaceuticals, Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68071-3079_4ab52a18-e552-14d9-e054-00144ff8d46c 68071-3079 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 NuCare Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68071-3080_4ab5cc65-a573-6c03-e054-00144ff88e88 68071-3080 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20111212 ANDA ANDA201407 NuCare Pharmaceuticals, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-3081_4ab91ea4-3ddc-5fd3-e054-00144ff88e88 68071-3081 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100607 ANDA ANDA075522 NuCare Pharmaceuticals, Inc. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68071-3082_4a4001a9-98bc-54ba-e054-00144ff8d46c 68071-3082 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20020314 ANDA ANDA065063 NuCare Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-3084_4a679629-b7f1-3e73-e054-00144ff88e88 68071-3084 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 NuCare Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3085_4aa44af9-1b3b-314c-e054-00144ff8d46c 68071-3085 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-3086_4a67adea-1588-633c-e054-00144ff8d46c 68071-3086 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 NuCare Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-3087_55f25ca5-7522-20a7-e054-00144ff88e88 68071-3087 HUMAN OTC DRUG Medi-First First Aid Eye Wash Water SOLUTION OPHTHALMIC 20111202 OTC MONOGRAPH FINAL part349 NuCare Pharmaceuticals,Inc. WATER .983 mg/mL N 20181231 68071-3088_4a6556e1-0614-6e09-e054-00144ff88e88 68071-3088 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 NuCare Pharmaceuticals, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-3089_4ab6f935-e089-6c1f-e054-00144ff8d46c 68071-3089 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 NuCare Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 68071-3092_4ab91ea4-3ddf-5fd3-e054-00144ff88e88 68071-3092 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 NuCare Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3093_4a405103-41e9-6a1f-e054-00144ff8d46c 68071-3093 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150109 ANDA ANDA202801 NuCare Pharmaceuticals, Inc. LEVOFLOXACIN 250 mg/1 N 20181231 68071-3095_4ab9c14a-480e-1031-e054-00144ff8d46c 68071-3095 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 NuCare Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68071-3096_4a66b854-4dd7-3746-e054-00144ff8d46c 68071-3096 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 NuCare Pharmaceuticals, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-3097_4a51c3e8-76fd-684f-e054-00144ff8d46c 68071-3097 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 19840501 NDA AUTHORIZED GENERIC NDA017532 NuCare Pharmaceuticals, Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-3098_4a649bb4-07dc-5748-e054-00144ff88e88 68071-3098 HUMAN OTC DRUG Rugby Travel Sickness Meclizine HCl, 25 mg Each (Antiemetic) Meclizine HCl TABLET, CHEWABLE ORAL 20140819 OTC MONOGRAPH FINAL part336 NuCare Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 68071-3099_4a69b54d-a8c3-52b1-e054-00144ff8d46c 68071-3099 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071258 NuCare Pharmaceuticals, Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68071-3100_4a6927be-d2d0-3e3d-e054-00144ff8d46c 68071-3100 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170105 ANDA ANDA202800 NuCare Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 68071-3101_4a6498fa-4a2f-47a3-e054-00144ff8d46c 68071-3101 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH FINAL part343 NuCare Pharmaceuticals, Inc. ASPIRIN 81 mg/1 N 20181231 68071-3102_4aa21e89-b1fe-41b7-e054-00144ff8d46c 68071-3102 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-3104_4a2a18ca-f0ec-5b8c-e054-00144ff8d46c 68071-3104 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 NuCare Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68071-3105_4ade0e07-0845-0624-e054-00144ff88e88 68071-3105 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir phosphate CAPSULE ORAL 20161212 ANDA ANDA202595 NuCare Pharmaceuticals, Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 68071-3107_4ab99175-6326-0584-e054-00144ff8d46c 68071-3107 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 NuCare Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-3108_4aa33e48-81ba-5c54-e054-00144ff88e88 68071-3108 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075828 NuCare Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3109_4a65192c-4a6c-5ded-e054-00144ff8d46c 68071-3109 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 NuCare Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68071-3110_4b6b2ce1-e34f-3921-e054-00144ff8d46c 68071-3110 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20150730 ANDA ANDA204597 NuCare Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3111_4a53ea53-3053-614b-e054-00144ff8d46c 68071-3111 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE EXTENDED RELEASE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20160512 ANDA ANDA090295 NuCare Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-3112_49dd1ec2-f02e-1ce1-e054-00144ff8d46c 68071-3112 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20130201 ANDA ANDA203253 NuCare Pharmaceuticals, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68071-3113_4aa40d43-772f-25db-e054-00144ff8d46c 68071-3113 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160425 ANDA ANDA202554 NuCare Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-3114_4a6498fa-4a06-47a3-e054-00144ff8d46c 68071-3114 HUMAN PRESCRIPTION DRUG fenofibrate fenofibrate TABLET ORAL 20140923 ANDA ANDA090715 NuCare Pharmaceuticals, Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68071-3115_4aa18675-91ae-29b1-e054-00144ff88e88 68071-3115 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20141209 ANDA ANDA200895 NuCare Pharmaceuticals, Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3116_4a3febe4-ddd8-4aa4-e054-00144ff88e88 68071-3116 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20151204 ANDA ANDA203584 NuCare Pharmaceuticals, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68071-3117_4a52465f-dec4-11f6-e054-00144ff8d46c 68071-3117 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 NuCare Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-3119_57e81711-44bb-2eee-e053-2991aa0aee26 68071-3119 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NuCare Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-3120_4a638186-a9b5-0503-e054-00144ff8d46c 68071-3120 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20120913 ANDA ANDA200243 NuCare Pharmaceuticals, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68071-3121_4ab77192-8fea-2965-e054-00144ff88e88 68071-3121 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 NuCare Pharmaceuticals, Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-3122_4aa518e1-d98a-1fde-e054-00144ff88e88 68071-3122 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 NuCare Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-3123_4aa44af9-1b00-314c-e054-00144ff8d46c 68071-3123 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 NuCare Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-3124_4a65192c-4a84-5ded-e054-00144ff8d46c 68071-3124 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071524 NuCare Pharmaceuticals, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68071-3125_4a649ea8-9bf2-43d1-e054-00144ff8d46c 68071-3125 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 NuCare Pharmaceuticals,Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3126_4a64f7c5-828a-6184-e054-00144ff88e88 68071-3126 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 NuCare Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-3127_4aa44b69-2947-2fb1-e054-00144ff8d46c 68071-3127 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 NuCare Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3128_4b6b2ce1-e34d-3921-e054-00144ff8d46c 68071-3128 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20151015 NDA AUTHORIZED GENERIC NDA018225 NuCare Pharmaceuticals, Inc. BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68071-3129_498b2f8c-846a-731e-e054-00144ff88e88 68071-3129 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 NuCare Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68071-3130_4b6b2ce1-e317-3921-e054-00144ff8d46c 68071-3130 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20150316 ANDA ANDA204597 NuCare Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3131_499f4cfd-6dee-3751-e054-00144ff88e88 68071-3131 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141226 ANDA ANDA202446 NuCare Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68071-3132_49a045c6-f844-257b-e054-00144ff8d46c 68071-3132 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19951130 ANDA ANDA074394 NuCare Pharmaceuticals, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3133_4a2af7fc-f25a-10b6-e054-00144ff8d46c 68071-3133 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 NuCare Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3134_49a0df95-df86-36b1-e054-00144ff8d46c 68071-3134 HUMAN PRESCRIPTION DRUG Nitrofurantion Nitrofurantion CAPSULE ORAL 20160415 ANDA ANDA201722 NuCare Pharmaceuticals Industries, Inc. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 68071-3135_56e09ff3-8600-2309-e054-00144ff8d46c 68071-3135 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20150525 ANDA ANDA203047 NuCare Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68071-3136_49c722f3-b3e5-3069-e054-00144ff88e88 68071-3136 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150722 ANDA ANDA065398 NuCare Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-3137_49c722f3-b3a1-3069-e054-00144ff88e88 68071-3137 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20130531 ANDA ANDA078380 NuCare Pharmaceuticals, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 68071-3138_49afdf89-0bee-71da-e054-00144ff88e88 68071-3138 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 NuCare Pharmaceuticals, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68071-3139_49afbdaf-244a-3760-e054-00144ff8d46c 68071-3139 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-3140_49afdf89-0b99-71da-e054-00144ff88e88 68071-3140 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 NuCare Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68071-3141_49b0543b-5e1a-50ee-e054-00144ff8d46c 68071-3141 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161221 ANDA ANDA076159 NuCare Pharmaceuticals Inc, GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-3142_49c86d54-f0f6-58fc-e054-00144ff8d46c 68071-3142 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 NuCare Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-3143_62ff1da3-79ab-676a-e053-2991aa0a4a9f 68071-3143 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 NuCare Pharmaceuticals,Inc. PREDNISONE 20 mg/1 N 20191231 68071-3144_49c61db6-71d4-555e-e054-00144ff8d46c 68071-3144 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 NuCare Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68071-3145_4a29b5a5-4250-36f6-e054-00144ff88e88 68071-3145 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160427 ANDA ANDA202554 NuCare Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-3146_4a2945a1-8686-3291-e054-00144ff8d46c 68071-3146 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 NuCare Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3147_49d77551-90e8-01bc-e054-00144ff88e88 68071-3147 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20070125 ANDA ANDA065352 NuCare Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-3149_4a29a31f-ec1d-4603-e054-00144ff8d46c 68071-3149 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 NuCare Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68071-3150_4ade0e07-07e5-0624-e054-00144ff88e88 68071-3150 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 NuCare Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68071-3151_4a28b750-2b91-0d28-e054-00144ff8d46c 68071-3151 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 NuCare Pharmaceuticals, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68071-3152_4a2b2e55-3fed-1b90-e054-00144ff8d46c 68071-3152 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NuCare Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-3153_4a404aab-c879-4597-e054-00144ff88e88 68071-3153 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20160120 ANDA ANDA202868 NuCare Pharmaceuticals, Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68071-3154_4fbbc5e1-7498-2ec5-e054-00144ff88e88 68071-3154 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 NuCare Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68071-3155_4a411d77-a8a2-1996-e054-00144ff8d46c 68071-3155 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 NuCarePharmaceuticals, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68071-3156_4ade94bb-6c3a-13cd-e054-00144ff8d46c 68071-3156 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070508 ANDA ANDA065332 NuCare Pharmaceuticals, Inc. CEFDINIR MONOHYDRATE 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-3157_4a54cf09-fabf-1eae-e054-00144ff8d46c 68071-3157 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 NuCare Pharmaceuticals, Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3158_4a402dba-c216-5db8-e054-00144ff8d46c 68071-3158 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 19811214 ANDA ANDA086183 NuCare Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68071-3159_4adc8290-1687-4b3f-e054-00144ff88e88 68071-3159 HUMAN PRESCRIPTION DRUG Diclofenac sodium Diclofenac GEL TOPICAL 20160321 ANDA ANDA208077 NuCare Pharmaceuticals, Inc. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3160_4a9fe0fa-5552-4e06-e054-00144ff8d46c 68071-3160 HUMAN OTC DRUG Regular Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals, Inc. ACETAMINOPHEN 325 mg/1 N 20181231 68071-3161_4aa040d4-b1e4-0254-e054-00144ff88e88 68071-3161 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20020314 ANDA ANDA065063 NuCare Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-3162_4aa1de75-ccc3-340f-e054-00144ff8d46c 68071-3162 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 NuCare Pharmaceuticals,Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68071-3163_4aa03876-8a17-55f6-e054-00144ff8d46c 68071-3163 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 NuCare Pharmaceuticals, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 68071-3164_4ac90af9-b3c8-19ad-e054-00144ff88e88 68071-3164 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 NuCare Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68071-3165_4acbfbc3-33dd-32cf-e054-00144ff8d46c 68071-3165 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 NuCare Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68071-3166_4acbb3c2-75f4-305f-e054-00144ff8d46c 68071-3166 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150109 ANDA ANDA202801 NuCare Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 68071-3167_4aba5bd9-bfd8-2471-e054-00144ff8d46c 68071-3167 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 NuCare Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3168_4ae01398-b1a3-2918-e054-00144ff88e88 68071-3168 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150722 ANDA ANDA065399 NuCare Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-3169_4acc107a-7e15-0130-e054-00144ff88e88 68071-3169 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150722 ANDA ANDA065399 NuCare Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-3170_4adfa75f-d081-48d1-e054-00144ff8d46c 68071-3170 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20160803 ANDA ANDA040197 NuCare Pharmaceuticals, Inc. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68071-3171_4ae05042-9cd0-69aa-e054-00144ff8d46c 68071-3171 HUMAN PRESCRIPTION DRUG ALENDRONATE SODIUM Alendronate sodium TABLET ORAL 20080804 ANDA ANDA076768 NuCare Pharmaceuticals, Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 68071-3172_4af220ed-646c-40e1-e054-00144ff88e88 68071-3172 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 NuCare Pharmaceuticals,Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3173_4af245ea-998f-1574-e054-00144ff8d46c 68071-3173 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 19880726 NDA AUTHORIZED GENERIC NDA018998 NuCare Pharmaceuticals, Inc. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-3174_4af33646-6054-6245-e054-00144ff88e88 68071-3174 HUMAN PRESCRIPTION DRUG Indomethacin extended-release Indomethacin extended-release CAPSULE ORAL 20151005 ANDA ANDA202706 NuCare Pharmaceuticals, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3175_4af1febe-dad0-61eb-e054-00144ff8d46c 68071-3175 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19910731 ANDA ANDA063083 NuCare Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68071-3176_4af2a165-0b7e-2539-e054-00144ff8d46c 68071-3176 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NuCare Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-3177_4af2f9ce-7201-2ec3-e054-00144ff8d46c 68071-3177 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 NuCare Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-3178_4b6dc0d4-4ace-3606-e054-00144ff8d46c 68071-3178 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 NuCare Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-3179_55f56cce-5d0c-0903-e054-00144ff8d46c 68071-3179 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE ORAL 20151019 ANDA ANDA203636 NuCare Pharmaceuticals,Inc. ESOMEPRAZOLE MAGNESIUM 40 1/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-3180_4b6b2ce1-e2b6-3921-e054-00144ff8d46c 68071-3180 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride labetalol hydrochloride TABLET ORAL 20141201 NDA NDA018716 NuCare Pharmaceuticals, Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-3181_62fc6878-b228-f5c7-e053-2991aa0a1c3a 68071-3181 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075511 NuCare Pharmaceuticals,Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 68071-3182_521b206c-e701-4a82-e054-00144ff8d46c 68071-3182 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-3183_51f43966-854f-161b-e054-00144ff88e88 68071-3183 HUMAN PRESCRIPTION DRUG Donepezil Donepezil hydrochloride TABLET ORAL 20150202 ANDA ANDA203034 NuCarePharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68071-3184_4b44ac98-225d-1739-e054-00144ff88e88 68071-3184 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 NuCare Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3185_4b442214-c3d0-2a3a-e054-00144ff8d46c 68071-3185 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040749 NuCare Pharmaceuticals, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68071-3186_51c76c6b-c64f-6d2e-e054-00144ff88e88 68071-3186 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 NuCarePharmaceuticals, Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-3187_55efe92b-129b-0a1e-e054-00144ff8d46c 68071-3187 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150818 ANDA ANDA065399 NuCare Pharmaceuticals,Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-3188_4be6c9ae-14ae-6892-e054-00144ff88e88 68071-3188 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-3189_4eb78632-dc65-5d99-e054-00144ff88e88 68071-3189 HUMAN OTC DRUG ASPIRIN 325 MG EC ASPIRIN TABLET ORAL 20151101 OTC MONOGRAPH FINAL part343 NuCare Pharmaceuticals, Inc. ASPIRIN 325 mg/1 N 20181231 68071-3190_4bce3ec1-d15b-62ba-e054-00144ff8d46c 68071-3190 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 NuCare Pharmaceuticals, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-3191_4bcdf2c6-dbdc-558f-e054-00144ff8d46c 68071-3191 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-3192_521b206c-e736-4a82-e054-00144ff8d46c 68071-3192 HUMAN PRESCRIPTION DRUG Donepezil Donepezil hydrochloride TABLET ORAL 20150202 ANDA ANDA203034 NuCare Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68071-3193_51c8a1cf-f4d4-0e4d-e054-00144ff8d46c 68071-3193 HUMAN OTC DRUG Sunmark Allergy Relief Antihistamine Diphenhydramine Hydrochloride SOLUTION ORAL 20030821 OTC MONOGRAPH FINAL part341 NuCare Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 68071-3195_4be79c9e-9585-0ef1-e054-00144ff88e88 68071-3195 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 NuCare Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-3196_4be3828e-3217-0596-e054-00144ff88e88 68071-3196 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 NuCare Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-3197_51f0f3cd-d638-2ae5-e054-00144ff8d46c 68071-3197 HUMAN OTC DRUG Hydrocortisone with Aloe Maximum Strength Hydrocortisone CREAM TOPICAL 19980708 OTC MONOGRAPH NOT FINAL part348 NuCare Pharmaceuticals, Inc. HYDROCORTISONE 1 g/100g N 20181231 68071-3198_51c9bd8b-d604-54a0-e054-00144ff8d46c 68071-3198 HUMAN PRESCRIPTION DRUG Donepezil Donepezil hydrochloride TABLET ORAL 20150202 ANDA ANDA203034 NuCare Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68071-3199_4b7c6d1c-1e73-59ac-e054-00144ff8d46c 68071-3199 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 NuCare Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68071-3200_4be6c9ae-1559-6892-e054-00144ff88e88 68071-3200 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 NuCare Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-3201_4b8186b0-ea75-73cc-e054-00144ff8d46c 68071-3201 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 NuCare Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68071-3202_4f44b89d-cd00-249c-e054-00144ff88e88 68071-3202 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20160803 ANDA ANDA040197 NuCare Pharmaceuticals, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68071-3203_4f450c60-fadd-4b9a-e054-00144ff8d46c 68071-3203 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20030121 ANDA ANDA075209 NuCare Pharmaceuticals, Inc. LORATADINE 10 mg/1 N 20181231 68071-3204_5048f7cd-d62f-33bd-e054-00144ff8d46c 68071-3204 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 NuCarePharmaceuticals,Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68071-3206_50499ec2-b793-561b-e054-00144ff8d46c 68071-3206 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxycycline hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 NuCare Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68071-3207_55dc8e66-030f-0ede-e054-00144ff88e88 68071-3207 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 19910731 ANDA ANDA063083 NuCare Pharmaceuticals,Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68071-3208_4fbd563e-b75e-212b-e054-00144ff8d46c 68071-3208 HUMAN OTC DRUG Loratadine Allergy Relief Loratadine TABLET ORAL 20030828 ANDA ANDA076134 NuCare Pharmaceuticals, Inc. LORATADINE 10 mg/1 N 20181231 68071-3209_518be80a-9729-51b8-e054-00144ff88e88 68071-3209 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-3211_51778813-0ec2-6b4f-e054-00144ff8d46c 68071-3211 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 NuCare Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68071-3212_518d79f7-5cd7-5af5-e054-00144ff8d46c 68071-3212 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20050114 ANDA ANDA077095 NuCare Pharmarmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-3213_51cb7348-d437-3838-e054-00144ff8d46c 68071-3213 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20161001 ANDA ANDA073085 NuCare Pharmaceuticals, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-3214_4f1f1e70-5d90-1166-e054-00144ff8d46c 68071-3214 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 NuCare Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68071-3215_51c9bf8c-847c-549c-e054-00144ff8d46c 68071-3215 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20070301 ANDA ANDA040702 NuCare Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-3216_4f1eb8ef-51e9-74b5-e054-00144ff8d46c 68071-3216 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-3218_631523e7-7d68-0cc3-e053-2a91aa0abb62 68071-3218 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150109 ANDA ANDA202801 NuCare Pharmaceuticals,Inc. LEVOFLOXACIN 750 mg/1 N 20191231 68071-3219_55270c7a-72d9-644d-e054-00144ff8d46c 68071-3219 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20110916 ANDA ANDA074164 NuCare Pharmaceuticals,Inc. MICONAZOLE NITRATE 2 g/100g N 20181231 68071-3220_51c7d6d4-368f-0a53-e054-00144ff88e88 68071-3220 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 NuCare Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-3221_5175a4c0-e71d-6701-e054-00144ff8d46c 68071-3221 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20000823 ANDA ANDA075479 NuCare Pharmaceuticals, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-3222_5176c7f9-9077-4797-e054-00144ff8d46c 68071-3222 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 NuCare Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68071-3223_63614efe-588e-33ec-e053-2a91aa0af01d 68071-3223 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20120501 ANDA ANDA090545 NuCare Pharmaceuticals,Inc. NAPROXEN SODIUM 220 mg/1 N 20191231 68071-3224_50490db4-9722-6d7e-e054-00144ff88e88 68071-3224 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073026 NuCare Pharmaceuticals, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-3226_51c9dd57-e17e-5558-e054-00144ff8d46c 68071-3226 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20020128 ANDA ANDA075978 NuCare Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-3227_503834f9-fa2f-5e23-e054-00144ff88e88 68071-3227 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 NuCare Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-3228_4ecc235c-57cc-0d3a-e054-00144ff8d46c 68071-3228 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 NuCare Pharmaceuticals, Inc. FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 68071-3229_51764347-8e0e-2fbb-e054-00144ff8d46c 68071-3229 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161215 ANDA ANDA202557 NuCare Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 68071-3230_4fe85b34-8fe9-56fa-e054-00144ff88e88 68071-3230 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20151230 ANDA ANDA090007 NuCare Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-3231_51ca74fe-3364-65dc-e054-00144ff88e88 68071-3231 HUMAN PRESCRIPTION DRUG Cromolyn Sodium cromolyn sodium SOLUTION/ DROPS OPHTHALMIC 19950130 ANDA ANDA074443 NuCare Pharmaceuticals, Inc. CROMOLYN SODIUM 40 mg/mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 68071-3232_50217921-9801-6ff2-e054-00144ff88e88 68071-3232 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 NuCare Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68071-3233_56456978-0cfa-56be-e054-00144ff88e88 68071-3233 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 NuCare Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68071-3234_6360d8cc-72df-c571-e053-2991aa0a72c5 68071-3234 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20071030 ANDA ANDA078341 NuCare Pharmaceuticals,Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20191231 68071-3235_4f1c940c-9f18-4289-e054-00144ff88e88 68071-3235 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NuCare Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-3236_4f43c350-542c-0c17-e054-00144ff8d46c 68071-3236 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 NuCarePharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 68071-3237_51775fb6-4764-04e2-e054-00144ff88e88 68071-3237 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, COATED ORAL 20110802 UNAPPROVED DRUG OTHER NuCare Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 68071-3238_518be80a-9752-51b8-e054-00144ff88e88 68071-3238 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20090702 ANDA ANDA040907 NuCare Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-3239_5021a45b-5ccb-0ef8-e054-00144ff8d46c 68071-3239 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20150714 ANDA ANDA202112 NuCare Pharmaceuticals, Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-3240_63761d78-ca62-512d-e053-2991aa0ae030 68071-3240 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161215 ANDA ANDA202557 NuCare Pharmaceuticals,Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20191231 68071-3241_4f1e9985-1d55-1c38-e054-00144ff88e88 68071-3241 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 NuCare Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68071-3242_50379c41-2677-590c-e054-00144ff8d46c 68071-3242 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 NuCare Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-3243_5037f569-3520-6734-e054-00144ff8d46c 68071-3243 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 NuCare Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68071-3244_4ecb3fe9-c831-5ef0-e054-00144ff8d46c 68071-3244 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20060915 ANDA ANDA077661 NuCare Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-3245_5175cf13-060a-187d-e054-00144ff8d46c 68071-3245 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 19851224 NDA AUTHORIZED GENERIC NDA018998 NuCare Pharmaceuticals, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-3246_5035d2a2-8386-118d-e054-00144ff88e88 68071-3246 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride Amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20101013 ANDA ANDA077890 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-3247_4f1f961c-12d0-3b2d-e054-00144ff88e88 68071-3247 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170216 ANDA ANDA207068 NuCare Pharmaceuticals, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3248_4ecba0ef-4f43-00c5-e054-00144ff88e88 68071-3248 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 NuCarePharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68071-3249_56e09ff3-85d5-2309-e054-00144ff8d46c 68071-3249 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20120913 ANDA ANDA200243 NuCare Pharmaceuticals, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68071-3250_4f1f76fe-8169-384a-e054-00144ff88e88 68071-3250 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19961002 NDA NDA050720 NuCare Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-3251_4f43c350-5420-0c17-e054-00144ff8d46c 68071-3251 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20150301 ANDA ANDA091145 NuCare Pharmaceuticals, Inc. FOLIC ACID 1 mg/1 N 20181231 68071-3252_517646d8-362c-5cf2-e054-00144ff88e88 68071-3252 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 NuCare Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68071-3253_4f1c86b4-2a21-45da-e054-00144ff88e88 68071-3253 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 NuCare Pharmaceuticals, Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3254_505e166f-e420-1b8c-e054-00144ff88e88 68071-3254 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SUPPOSITORY RECTAL 20150601 ANDA ANDA040428 NuCare Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68071-3255_51764347-8e16-2fbb-e054-00144ff8d46c 68071-3255 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19860730 ANDA ANDA085223 NuCare Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68071-3256_5177135c-86b4-38ca-e054-00144ff8d46c 68071-3256 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 NuCare Pharmaceuticals, Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68071-3258_4f43ca14-d456-0a66-e054-00144ff8d46c 68071-3258 HUMAN PRESCRIPTION DRUG Quinapril Quinapril Hydrochloride TABLET, FILM COATED ORAL 20130429 ANDA ANDA202725 NuCare Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68071-3259_50217b0f-a6e4-6c82-e054-00144ff88e88 68071-3259 HUMAN PRESCRIPTION DRUG Prochlorperazine Prochlorperazine SUPPOSITORY RECTAL 19931130 ANDA ANDA040058 NuCare Pharmaceuticals, Inc. PROCHLORPERAZINE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68071-3261_50217b0f-a68f-6c82-e054-00144ff88e88 68071-3261 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 NuCare Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3262_51763f03-6ce9-5dc0-e054-00144ff88e88 68071-3262 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 NuCare Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 68071-3263_505e8cdf-25e5-2a2a-e054-00144ff88e88 68071-3263 HUMAN PRESCRIPTION DRUG Metoprolol tartrate Metoprolol tartrate TABLET ORAL 20150629 ANDA ANDA076670 NuCare Pharmaceuticals, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-3264_4ecc1993-aab3-1352-e054-00144ff88e88 68071-3264 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 NuCare Pharmaceutical, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68071-3265_4f434cbc-318c-6554-e054-00144ff88e88 68071-3265 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 NuCare Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3266_4f4374b8-e106-68ea-e054-00144ff88e88 68071-3266 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 NuCare Pharmaceuticals, Inc. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68071-3267_51f23212-a10e-4cfa-e054-00144ff88e88 68071-3267 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160804 ANDA ANDA205519 NuCare Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3268_503874cf-9a19-0a49-e054-00144ff8d46c 68071-3268 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 NuCare Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-3269_5021c769-3e1a-05ce-e054-00144ff88e88 68071-3269 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 NuCare Pharmaceuticals, Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68071-3270_4fe78272-1bb4-2c1f-e054-00144ff8d46c 68071-3270 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071135 NuCare Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-3271_4ec9edbe-c535-475b-e054-00144ff88e88 68071-3271 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 NuCare Pharmaceuticals ,Inc. LEVOFLOXACIN 750 mg/1 N 20181231 68071-3272_4eca42e2-64b0-51ca-e054-00144ff88e88 68071-3272 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170105 ANDA ANDA202800 NuCare Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 68071-3274_5163a6dc-f020-592a-e054-00144ff88e88 68071-3274 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20080825 ANDA ANDA077419 NuCare Pharmaceuticals, Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68071-3275_51ca244c-6fca-66c0-e054-00144ff8d46c 68071-3275 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron Hydrochloride SOLUTION ORAL 20110127 ANDA ANDA091342 NuCare Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-3276_5033e600-1ac7-1a91-e054-00144ff8d46c 68071-3276 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20070131 ANDA ANDA076588 NuCare Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68071-3277_503455d9-471f-554f-e054-00144ff88e88 68071-3277 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 NuCare Pharmaceuticals, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3278_51674ad0-4ca0-5b02-e054-00144ff88e88 68071-3278 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride TABLET, FILM COATED ORAL 20160930 ANDA ANDA203854 NuCare Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3279_5023ffd9-3314-4f05-e054-00144ff88e88 68071-3279 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 NuCare Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68071-3280_5023c851-d25c-48f1-e054-00144ff88e88 68071-3280 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110131 ANDA ANDA090404 NuCare Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68071-3281_503481f1-b0c3-44bd-e054-00144ff8d46c 68071-3281 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 NuCare Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-3282_50348652-fc2b-3f1d-e054-00144ff8d46c 68071-3282 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 NuCare Pharmaceuticals, Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 68071-3283_5023aab4-7832-4380-e054-00144ff88e88 68071-3283 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram Oxalate TABLET, FILM COATED ORAL 20120911 ANDA ANDA202210 NuCarePharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/21 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3284_50345702-986a-5335-e054-00144ff88e88 68071-3284 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 NuCare Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3285_50242cec-7828-21a4-e054-00144ff8d46c 68071-3285 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 NuCare Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-3286_503597ae-3f52-0a88-e054-00144ff88e88 68071-3286 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20160419 ANDA ANDA202036 NuCare Pharmaceuticals, Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3287_5033e600-1b2e-1a91-e054-00144ff8d46c 68071-3287 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20121018 ANDA ANDA075269 NuCare Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-3288_5166f770-63a4-5183-e054-00144ff88e88 68071-3288 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 NuCare Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68071-3289_5033d469-4d64-436e-e054-00144ff88e88 68071-3289 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20130902 ANDA ANDA078155 NuCare Pharmaceuticals, Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3290_504b67f5-3103-4525-e054-00144ff88e88 68071-3290 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET ORAL 20101225 NDA AUTHORIZED GENERIC NDA018602 NuCare Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68071-3291_521aa21c-070b-334f-e054-00144ff8d46c 68071-3291 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20060329 ANDA ANDA065308 NuCare Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-3292_505d8904-7862-27a6-e054-00144ff8d46c 68071-3292 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NuCare Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-3293_552b1532-4a4e-2984-e054-00144ff8d46c 68071-3293 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-3294_55276d57-b317-0acc-e054-00144ff88e88 68071-3294 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20060811 ANDA ANDA076369 NuCare Pharmaceuticals,Inc. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] N 20181231 68071-3295_552b90d2-d647-3c68-e054-00144ff8d46c 68071-3295 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070508 ANDA ANDA065332 NuCare Pharmaceuticals,Inc. CEFDINIR MONOHYDRATE 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-3296_505d0594-e88a-0de8-e054-00144ff8d46c 68071-3296 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 NuCare Pharmaceuticals, Inc. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68071-3298_505d3c4c-5507-72cc-e054-00144ff88e88 68071-3298 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 NuCare Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68071-3299_6315850e-f844-a114-e053-2a91aa0a4016 68071-3299 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NuCare Pharmaceuticals,Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 68071-3300_5166d1f5-fd87-4b79-e054-00144ff88e88 68071-3300 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 NuCare Pharmaceuticals, Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68071-3301_5166e092-461c-34a1-e054-00144ff8d46c 68071-3301 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 NuCarePharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-3302_504b6af7-e15f-47e4-e054-00144ff88e88 68071-3302 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 19961002 NDA NDA050720 NuCare Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-3303_505d5616-07c0-1e82-e054-00144ff8d46c 68071-3303 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 19851224 NDA AUTHORIZED GENERIC NDA018998 NuCare Pharmaceuticals, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-3305_505d5824-9d78-1ee5-e054-00144ff8d46c 68071-3305 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 NuCare Pharmaceutical, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68071-3306_5526e66a-db05-6c4d-e054-00144ff88e88 68071-3306 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20100528 ANDA ANDA090121 NuCare Pharmaceuticals,Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68071-3307_5034abdf-e5ec-5057-e054-00144ff88e88 68071-3307 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20130513 ANDA ANDA090867 NuCare Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68071-3308_62fce412-d5e4-1c7f-e053-2991aa0af094 68071-3308 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 20100604 ANDA ANDA040659 NuCare Pharmaceuticals,Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20191231 68071-3309_51747103-8743-22f5-e054-00144ff88e88 68071-3309 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170209 ANDA ANDA202825 NuCare Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3310_51742add-363e-3f9d-e054-00144ff8d46c 68071-3310 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19860619 ANDA ANDA085082 NuCare Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68071-3311_5163e650-d921-0d3c-e054-00144ff8d46c 68071-3311 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET ORAL 20150513 ANDA ANDA079128 NuCare Pharmaceuticals,Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68071-3312_5163a2ab-772c-69a6-e054-00144ff8d46c 68071-3312 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 NuCare Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3313_5174271d-c77f-2e71-e054-00144ff8d46c 68071-3313 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NuCare Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-3314_51742673-bdc0-4159-e054-00144ff8d46c 68071-3314 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 NuCare Pharmaceuticals, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-3315_5163e676-12aa-0c09-e054-00144ff8d46c 68071-3315 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20001204 ANDA ANDA075269 NuCare Pharmaceuticals, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-3316_5527380d-ce85-695f-e054-00144ff8d46c 68071-3316 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20060811 ANDA ANDA076369 NuCare Pharmaceuticals,Inc. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] N 20181231 68071-3317_521a59d3-4e18-194c-e054-00144ff8d46c 68071-3317 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 NuCare Pharmaceuticals, Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68071-3318_5163e650-d92b-0d3c-e054-00144ff8d46c 68071-3318 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20160129 ANDA ANDA090223 NuCare Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3319_553b4938-4463-4aeb-e054-00144ff88e88 68071-3319 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 NuCare Pharmaceuticals,Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68071-3320_5166e092-465c-34a1-e054-00144ff8d46c 68071-3320 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950217 ANDA ANDA074056 NuCare Pharmaceuticals, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-3321_567fc4b2-15ad-429e-e054-00144ff88e88 68071-3321 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110131 ANDA ANDA090404 NuCare Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68071-3322_5526b9c1-3ada-57a5-e054-00144ff8d46c 68071-3322 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide SOLUTION TOPICAL 20140228 NDA NDA018849 NuCare Pharmaceuticals,Inc. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-3323_53fe1730-a804-26b2-e054-00144ff88e88 68071-3323 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 NuCare Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-3324_53fea330-cc4b-3b7e-e054-00144ff88e88 68071-3324 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 NuCare Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-3325_54115b53-6e96-6d49-e054-00144ff88e88 68071-3325 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021106 ANDA ANDA076201 NuCare Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3326_55f01fe0-ebea-4a92-e054-00144ff88e88 68071-3326 HUMAN PRESCRIPTION DRUG Estradiol estradiol PATCH, EXTENDED RELEASE TRANSDERMAL 20141222 NDA AUTHORIZED GENERIC NDA020538 NuCare Pharmaceuticals,Inc. ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68071-3327_540e2d72-4ca0-16e1-e054-00144ff8d46c 68071-3327 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20110425 ANDA ANDA078552 NuCare Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-3328_53fc0cf8-5d97-41f9-e054-00144ff8d46c 68071-3328 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, COATED ORAL 20110802 UNAPPROVED DRUG OTHER NuCare Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 68071-3329_544d68a2-2e43-133b-e054-00144ff88e88 68071-3329 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET ORAL 20121108 ANDA ANDA202025 NuCare Pharmaceuticals, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 68071-3330_5411f993-0e28-0cab-e054-00144ff88e88 68071-3330 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071135 NuCare Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-3331_544ada2f-87a6-26cf-e054-00144ff88e88 68071-3331 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20140806 ANDA ANDA075536 NuCare Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68071-3333_553c3301-a92e-675f-e054-00144ff88e88 68071-3333 HUMAN PRESCRIPTION DRUG Procto-Med HC HYDROCORTISONE CREAM TOPICAL 20160509 ANDA ANDA089682 NuCare Pharmaceuticals,Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-3334_55270cbf-3e4e-565e-e054-00144ff8d46c 68071-3334 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 NuCare Pharmaceuticals,Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68071-3335_57478437-02ab-b7ed-e053-2a91aa0a49d3 68071-3335 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 NuCare Pharmaceuticals, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-3336_540f375c-99cd-4444-e054-00144ff8d46c 68071-3336 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161215 ANDA ANDA202557 NuCare Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 68071-3337_5412241f-3043-068f-e054-00144ff8d46c 68071-3337 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 NuCare Pharmaceuticals, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-3338_544d7573-2138-577a-e054-00144ff8d46c 68071-3338 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20150402 ANDA ANDA065062 NuCare Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68071-3339_5411a89e-6b86-5eb3-e054-00144ff8d46c 68071-3339 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NuCare [Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-3340_54d6543d-423a-58b1-e054-00144ff88e88 68071-3340 HUMAN PRESCRIPTION DRUG ALENDRONATE SODIUM Alendronate sodium TABLET ORAL 20080804 ANDA ANDA076768 NuCare Pharmaceuticals,Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 68071-3341_54116886-ea5f-5320-e054-00144ff8d46c 68071-3341 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 NuCare Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68071-3342_53fe5e76-e768-324e-e054-00144ff88e88 68071-3342 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NuCare Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-3343_549efb5c-737d-28b8-e054-00144ff8d46c 68071-3343 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 NuCare Pharmaceuticals,Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-3344_54c4e10d-fa6c-5bec-e054-00144ff88e88 68071-3344 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140620 ANDA ANDA076658 Nucare Pharmaceuticals,Inc FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68071-3345_548bfee3-f4a4-2090-e054-00144ff88e88 68071-3345 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20160706 ANDA ANDA091416 NuCare Pharmaceuticals,Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3346_5488147e-6a10-15c8-e054-00144ff88e88 68071-3346 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20070725 ANDA ANDA040627 Nucare Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68071-3347_54884673-16d3-16b6-e054-00144ff88e88 68071-3347 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 NuCare Pharmaceuticals,Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-3348_54c6f8f4-5431-3988-e054-00144ff8d46c 68071-3348 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, COATED ORAL 20161031 ANDA ANDA201619 NuCare Pharmaceuticals,Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3349_54d6543d-427a-58b1-e054-00144ff88e88 68071-3349 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, COATED ORAL 20161031 ANDA ANDA201619 NuCare Pharmaceuticals,Inc. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3350_54c6f8f4-5467-3988-e054-00144ff8d46c 68071-3350 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20090817 ANDA ANDA078327 NuCare Pharmaceuticals,Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68071-3351_54c73290-bd8a-3453-e054-00144ff88e88 68071-3351 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20040507 NDA AUTHORIZED GENERIC NDA019992 NuCare Pharmaceuticals,Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68071-3352_5411544e-3c2e-4e42-e054-00144ff8d46c 68071-3352 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 NuCare Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68071-3353_54dacae4-2f9e-0b31-e054-00144ff88e88 68071-3353 HUMAN OTC DRUG banophen Diphenhydramine HCl LIQUID ORAL 20061120 OTC MONOGRAPH FINAL part341 NuCare Pharmaceuticals,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 68071-3354_54c73290-bdc2-3453-e054-00144ff88e88 68071-3354 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20100528 ANDA ANDA090121 NuCare Pharmaceuticals,Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68071-3355_549f1d1a-81f6-29f5-e054-00144ff8d46c 68071-3355 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20130411 ANDA ANDA202717 NuCare Pharmaceuticals,Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68071-3356_548a84fc-7716-673b-e054-00144ff88e88 68071-3356 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140328 ANDA ANDA201003 Nucare Pharmaceuticals,Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 68071-3357_544ba802-a537-579a-e054-00144ff88e88 68071-3357 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 NuCare Pharmaceuticals,Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3358_54225475-fa73-6040-e054-00144ff88e88 68071-3358 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170216 ANDA ANDA207068 NuCare Pharmaceuticals, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3359_54da7bef-c3b1-4353-e054-00144ff8d46c 68071-3359 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone neomycin sulfate, polymyxin b sulfate and dexamethasone SUSPENSION OPHTHALMIC 19960221 ANDA ANDA062341 NuCare Pharmaceuticals,Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-3360_544ac61d-973c-3ff1-e054-00144ff8d46c 68071-3360 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 NuCare Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68071-3361_54228087-7ab1-5561-e054-00144ff8d46c 68071-3361 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 NuCare Pharmaceuticals, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3362_553c8cfa-cf10-0b1f-e054-00144ff88e88 68071-3362 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20151230 ANDA ANDA090796 NuCare Pharmaceuticals,Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3363_54dacae4-2f9d-0b31-e054-00144ff88e88 68071-3363 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 20161024 ANDA ANDA208136 NuCare Pharmaceuticals,Inc. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-3364_55f10368-1557-67f5-e054-00144ff88e88 68071-3364 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 NuCare Pharmaceuticals,Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-3365_548a9f30-523c-5d73-e054-00144ff8d46c 68071-3365 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 NuCare Pharmaceuticals,Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-3366_548bdd9f-dcc7-28c7-e054-00144ff8d46c 68071-3366 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20110718 ANDA ANDA076341 NuCare Pharmaceuticals,Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3367_548b04a9-6073-0251-e054-00144ff88e88 68071-3367 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20160129 ANDA ANDA090223 NuCare Pharmaceuticals,Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3368_5499ffef-c655-0a5b-e054-00144ff8d46c 68071-3368 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150819 ANDA ANDA203270 NuCare Pharmaceuticals,Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-3369_553f3a02-abe3-668c-e054-00144ff8d46c 68071-3369 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 NuCare Pharmaceuticals,Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 68071-3370_54113cf0-5133-4a42-e054-00144ff8d46c 68071-3370 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20170711 ANDA ANDA203686 NuCare Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-3371_54c653b7-2df7-19e3-e054-00144ff88e88 68071-3371 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20170426 ANDA ANDA205300 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3372_54d58e00-645c-340e-e054-00144ff8d46c 68071-3372 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20100524 ANDA ANDA077655 NuCare Pharmaceuticals,Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68071-3373_53fd485c-ae98-2124-e054-00144ff8d46c 68071-3373 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 NuCare Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68071-3374_54da7bef-c393-4353-e054-00144ff8d46c 68071-3374 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20170426 ANDA ANDA205300 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3375_540ee876-78fa-1792-e054-00144ff88e88 68071-3375 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170711 ANDA ANDA203512 NuCare Pharmaceuticals, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68071-3376_53fcee89-027b-13e5-e054-00144ff8d46c 68071-3376 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 NuCarePharmaceuticals, Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 68071-3377_55ddafc3-41f6-3566-e054-00144ff88e88 68071-3377 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20170330 ANDA ANDA077797 NuCare Pharmaceuticals,Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68071-3378_549bc21c-6c96-37f3-e054-00144ff88e88 68071-3378 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20030101 OTC MONOGRAPH FINAL part333B NuCare Pharmaceuticals,Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 68071-3379_540d3033-12cd-5f8a-e054-00144ff8d46c 68071-3379 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170209 ANDA ANDA202825 NuCare Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3380_549aab5d-819b-1691-e054-00144ff88e88 68071-3380 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20100528 ANDA ANDA090121 NuCare Pharmaceuticals,Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68071-3381_540f4b0c-2d0b-1e0b-e054-00144ff88e88 68071-3381 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20100524 ANDA ANDA090682 NuCare Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68071-3382_53fbc93a-7863-33c1-e054-00144ff8d46c 68071-3382 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20020816 ANDA ANDA076070 NuCare Pharmaceuticals, Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-3383_549a5b3f-496a-1ae5-e054-00144ff8d46c 68071-3383 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 NuCare Pharmaceuticals,Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-3384_549a5b3f-4929-1ae5-e054-00144ff8d46c 68071-3384 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 NuCare Pharmaceuticals,Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-3385_54d8dee0-99f4-3d0f-e054-00144ff88e88 68071-3385 HUMAN PRESCRIPTION DRUG OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE ORAL 20170224 ANDA ANDA208578 NuCare Pharmaceuticals,Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 68071-3386_54231bef-dd70-0400-e054-00144ff88e88 68071-3386 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 NuCare Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68071-3387_540f375c-99e9-4444-e054-00144ff8d46c 68071-3387 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20170711 ANDA ANDA075927 NuCare Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3388_54112b16-b527-677a-e054-00144ff88e88 68071-3388 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 NuCare Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-3389_549efb5c-73b2-28b8-e054-00144ff8d46c 68071-3389 HUMAN OTC DRUG Childrens MAPAP Acetaminophen Acetaminophen LIQUID ORAL 20120820 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals,Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 68071-3390_542385ba-6f67-06fe-e054-00144ff8d46c 68071-3390 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20170330 ANDA ANDA077797 NuCare Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68071-3391_54c28733-eb9a-10f6-e054-00144ff88e88 68071-3391 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 NuCare Pharmaceuticals,Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3392_54dacae4-3007-0b31-e054-00144ff88e88 68071-3392 HUMAN OTC DRUG Major Clotrimazole CLOTRIMAZOLE CREAM TOPICAL 20041004 OTC MONOGRAPH FINAL part333C NuCare Pharmaceuticals,Inc. CLOTRIMAZOLE 10 mg/g N 20181231 68071-3393_54c73290-bd6b-3453-e054-00144ff88e88 68071-3393 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20131004 ANDA ANDA065429 NuCare Pharmaceauticals,Inc. CEFDINIR MONOHYDRATE 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-3394_5423c0da-eb11-20cd-e054-00144ff8d46c 68071-3394 HUMAN PRESCRIPTION DRUG ESTRADIOL ESTRADIOL TABLET ORAL 20170410 ANDA ANDA040275 NuCare Pharmaceuticals, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68071-3395_5423d703-f342-1b9d-e054-00144ff88e88 68071-3395 HUMAN OTC DRUG clotrimazole Clotrimazole CREAM TOPICAL 20110603 OTC MONOGRAPH FINAL part333C NuCare Pharmaceuticals, Inc. CLOTRIMAZOLE 1 g/100g N 20181231 68071-3396_54375375-e9cf-1885-e054-00144ff8d46c 68071-3396 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20111101 ANDA ANDA200292 NuCare Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68071-3397_5436442d-57ea-71f3-e054-00144ff8d46c 68071-3397 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 NuCare Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-3398_5436a0ac-dd6a-4a34-e054-00144ff88e88 68071-3398 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 NuCare Pharmaceuticals, Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68071-3399_54375375-e9d3-1885-e054-00144ff8d46c 68071-3399 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-4000_543a43c6-c25d-5168-e054-00144ff8d46c 68071-4000 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 NuCare Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-4001_543ac930-6784-52b1-e054-00144ff88e88 68071-4001 HUMAN OTC DRUG good sense tussin dm Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 19910918 OTC MONOGRAPH FINAL part341 NuCare Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 68071-4003_544dd14b-ce39-2f1b-e054-00144ff88e88 68071-4003 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 NuCare Pharmaceuticals, Inc. MIRTAZAPINE 30 mg/1 N 20181231 68071-4004_544ddf40-c75f-564c-e054-00144ff8d46c 68071-4004 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 19940727 ANDA ANDA040064 NuCare Pharmaceuticals, Inc. TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68071-4005_54b091b8-0fab-4329-e054-00144ff88e88 68071-4005 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 NuCare Pharmaceuticals,Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68071-4006_5487c369-419b-269e-e054-00144ff8d46c 68071-4006 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20160706 ANDA ANDA091416 NuCare Pharmaceuticals,Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-4007_54b06071-f3cc-5627-e054-00144ff8d46c 68071-4007 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20080107 ANDA ANDA065434 NuCare Pharmaceuticals,Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-4008_54b278c6-3bbc-5008-e054-00144ff8d46c 68071-4008 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 NuCare Pharmaceuticals,Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68071-4009_54b25106-5581-119d-e054-00144ff88e88 68071-4009 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20151230 ANDA ANDA090796 NuCare Pharmaceuticals,Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-4010_54c23582-efe7-3d9d-e054-00144ff8d46c 68071-4010 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031107 ANDA ANDA076467 NuCare Pharmaceuticals,Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-4011_54c236ce-695f-06ef-e054-00144ff88e88 68071-4011 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET ORAL 20170323 ANDA ANDA077836 NuCare Pharmaceuticals,Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 68071-4012_55140bff-58d3-3ae2-e054-00144ff88e88 68071-4012 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075319 NuCare Pharmaceuticals, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68071-4013_602cc683-fc05-6645-e053-2a91aa0a62a4 68071-4013 HUMAN PRESCRIPTION DRUG DermacinRx SilaPak Triamcinolone Acetonide Cream Kit KIT 20150818 ANDA ANDA088042 NuCare Pharmaceuticals,Inc. N 20181231 68071-4014_55144f07-45c9-3266-e054-00144ff88e88 68071-4014 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 NuCare Pharmaceuticals, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-4015_5541180b-9930-24f9-e054-00144ff88e88 68071-4015 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 NuCare Pharmaceuticals,Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68071-4017_55276dd1-a916-71dd-e054-00144ff8d46c 68071-4017 HUMAN PRESCRIPTION DRUG Alendronate ALENDRONATE SODIUM TABLET ORAL 20150930 ANDA ANDA090258 NuCare Pharmaceuticals,Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 68071-4018_55279917-5e0e-0fda-e054-00144ff88e88 68071-4018 HUMAN PRESCRIPTION DRUG Chlorthalidone Chlorthalidone TABLET ORAL 20160212 ANDA ANDA089286 NuCare Pharmaceuticals,Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 68071-4019_5527321b-4945-6961-e054-00144ff8d46c 68071-4019 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-4020_554edf17-07f9-5bc1-e054-00144ff8d46c 68071-4020 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161221 ANDA ANDA076159 NuCare Pharmaceuticals,Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-4021_555061d4-276b-4716-e054-00144ff88e88 68071-4021 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 NuCare Pharmaceuticals,Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-4023_55530ff3-5ce5-120f-e054-00144ff8d46c 68071-4023 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 NuCare Pharmaceuticals,Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68071-4024_5564c9dc-6f9a-6639-e054-00144ff8d46c 68071-4024 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 NuCare Pharmaceuticals,Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-4025_55a2568d-8987-1c7a-e054-00144ff88e88 68071-4025 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20021104 ANDA ANDA075410 NuCare Pharmaceuticals,Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-4027_55a46555-46a0-05b3-e054-00144ff88e88 68071-4027 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20140909 ANDA ANDA063083 NuCare Pharmaceuticals,Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68071-4029_55c7b55c-b775-3e0d-e054-00144ff88e88 68071-4029 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170209 ANDA ANDA202825 NuCare Pharmaceuticals,Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-4030_55dbd866-1fcd-6d11-e054-00144ff88e88 68071-4030 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071136 NuCare Pharmaceuticals,Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-4031_55dbd02e-8de2-6b8f-e054-00144ff88e88 68071-4031 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET ORAL 20121016 ANDA ANDA202928 NuCare Pharmaceuticals,Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68071-4032_59410e9f-a584-7ee5-e053-2991aa0ac263 68071-4032 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065096 NuCare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-4033_5631bb72-798b-6efc-e054-00144ff8d46c 68071-4033 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20020129 ANDA ANDA076001 NuCare Pharmaceuticals,Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-4034_56429f04-97b7-06a9-e054-00144ff88e88 68071-4034 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET ORAL 20120228 ANDA ANDA203366 NuCare Pharmaceuticals,Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68071-4035_56428b69-ef05-342e-e054-00144ff8d46c 68071-4035 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20130213 ANDA ANDA200044 NuCare Pharmaceuticals,Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 68071-4036_56547f85-8309-16bf-e054-00144ff8d46c 68071-4036 HUMAN PRESCRIPTION DRUG Losartan potassium Losartan potassium TABLET, FILM COATED ORAL 20120601 ANDA ANDA202230 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-4037_56549401-bbd7-3ae9-e054-00144ff88e88 68071-4037 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SOLUTION ORAL 20060131 ANDA ANDA040650 NuCare Pharmaceuticals,Inc. PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 68071-4039_56560d13-4161-204c-e054-00144ff8d46c 68071-4039 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170216 ANDA ANDA207068 NuCare Pharmaceuticals,Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-4040_615543ed-0bac-0570-e053-2991aa0aa137 68071-4040 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET, FILM COATED ORAL 20110425 ANDA ANDA090370 NuCare Pharmaceuticals,Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68071-4041_56692e8a-057f-5fd3-e054-00144ff88e88 68071-4041 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20160503 ANDA ANDA091368 NuCare Pharmaceuticals,Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68071-4042_56692e8a-05da-5fd3-e054-00144ff88e88 68071-4042 HUMAN PRESCRIPTION DRUG Diclofenac Potassium diclofenac potassium TABLET, FILM COATED ORAL 19990917 ANDA ANDA075463 NuCare Pharmaceuticals,Inc. DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-4043_56693f35-bf3f-5a11-e054-00144ff88e88 68071-4043 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 NuCare Pharmaceuticals,Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-4044_566a8fd7-fba8-2297-e054-00144ff8d46c 68071-4044 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20100528 ANDA ANDA090121 NuCare Pharmaceuticals,Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68071-4045_566a65be-4cf5-12fb-e054-00144ff88e88 68071-4045 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 NuCare Pharmaceuticals,Inc. MIRTAZAPINE 15 mg/1 N 20181231 68071-4046_566a65be-4cfa-12fb-e054-00144ff88e88 68071-4046 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-4047_566a8fd7-fc01-2297-e054-00144ff8d46c 68071-4047 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20130411 ANDA ANDA202717 NuCare Pharmaceuticals,Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68071-4048_616aa460-7851-9f4d-e053-2a91aa0a5d58 68071-4048 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 NuCare Pharmaceuticals,Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68071-4049_567cd315-7b9a-199d-e054-00144ff8d46c 68071-4049 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20151230 ANDA ANDA090007 NuCare Pharmaceuticals,Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-4050_56baef33-1dfc-62ff-e054-00144ff88e88 68071-4050 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE DENTAL 20170113 ANDA ANDA205592 NuCare Pharmaceuticals,Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-4051_56e23df2-aa0e-6aa6-e054-00144ff8d46c 68071-4051 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 NuCare Pharmaceuticals,Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-4052_56e70f5e-5ebd-1922-e054-00144ff88e88 68071-4052 HUMAN OTC DRUG Childrens Silapap Acetaminophen LIQUID ORAL 19940905 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals,Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 68071-4053_56e33071-420b-2039-e054-00144ff88e88 68071-4053 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET ORAL 20170323 ANDA ANDA077836 NuCare Pharmaceuticals,Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 68071-4054_56f6247e-5d43-0924-e054-00144ff88e88 68071-4054 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA090984 NuCare Pharmaceuticals,Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68071-4055_56e63be5-c14b-4859-e054-00144ff8d46c 68071-4055 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20080701 ANDA ANDA076407 NuCare Pharmaceuticals,Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68071-4056_56f76943-678e-3826-e054-00144ff88e88 68071-4056 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20021031 ANDA ANDA065101 NuCare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-4057_56f72c95-63c7-30f6-e054-00144ff88e88 68071-4057 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20170505 ANDA ANDA204165 NuCare Pharmaceuticals,Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68071-4058_56f91b08-f805-6866-e054-00144ff88e88 68071-4058 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-4059_56f8cae3-a5c1-5f29-e054-00144ff88e88 68071-4059 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-4060_570ac9c9-f13a-336d-e054-00144ff88e88 68071-4060 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20120320 OTC MONOGRAPH NOT FINAL part334 NuCare Pharmaceuticals,Inc. MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 68071-4061_5745c719-b72a-3efb-e053-2a91aa0a9a1d 68071-4061 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate U-D TABLET ORAL 20090817 ANDA ANDA078327 NuCare Pharmaceuticals,Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68071-4062_5745c719-b72f-3efb-e053-2a91aa0a9a1d 68071-4062 HUMAN PRESCRIPTION DRUG Losartan potassium Losartan potassium TABLET, FILM COATED ORAL 20120601 ANDA ANDA202230 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-4063_575c38b4-7ec1-6d25-e053-2a91aa0a80fc 68071-4063 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20170620 ANDA ANDA086727 NuCare Pharmaceuticals,Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 68071-4064_576e41b7-2e67-0962-e053-2991aa0ab4b7 68071-4064 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NuCare Pharmaceuticals,Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-4065_579b1f76-129a-684f-e053-2a91aa0a83d7 68071-4065 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100419 ANDA ANDA077183 NuCare Pharmaceuticals,Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-4066_57d528b9-0abc-36c9-e053-2991aa0a5f86 68071-4066 HUMAN PRESCRIPTION DRUG Amlodipine besylate and benazepril hydrochloride Amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 20101013 ANDA ANDA077890 NuCare Pharmaceuticals,Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-4067_57d781c3-c2aa-0c59-e053-2991aa0aaa2c 68071-4067 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20081028 ANDA ANDA078536 NuCare Pharmaceuticals,Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 68071-4068_57d781c3-c2df-0c59-e053-2991aa0aaa2c 68071-4068 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 NuCare Pharmaceuticals,Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-4069_57d83d13-1926-d0ba-e053-2991aa0abfb5 68071-4069 HUMAN OTC DRUG Rugby Benzoyl Peroxide Acne Medication Benzoyl Peroxide GEL TOPICAL 20150120 OTC MONOGRAPH FINAL part333D NuCare Pharmaceuticals,Inc. BENZOYL PEROXIDE 100 mg/mL N 20181231 68071-4070_57fcfec0-23c3-570c-e053-2991aa0ab532 68071-4070 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110131 ANDA ANDA090404 NuCare Pharmaceuticals,Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68071-4071_57fcfec0-23b9-570c-e053-2991aa0ab532 68071-4071 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, COATED ORAL 20110802 UNAPPROVED DRUG OTHER NuCare Pharmaceuticals,Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 68071-4072_58106fd7-d266-3fe9-e053-2a91aa0ade1a 68071-4072 HUMAN PRESCRIPTION DRUG Alendronate ALENDRONATE SODIUM TABLET ORAL 20150930 ANDA ANDA090258 NuCare Pharmaceuticals,Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 68071-4073_5813360c-e007-934e-e053-2a91aa0a7f12 68071-4073 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20130201 ANDA ANDA203253 NuCare Pharmaceuticals,Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68071-4074_5811bd51-fbf7-4bd1-e053-2a91aa0a850a 68071-4074 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA076862 NuCare Pharmaceuticals,Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-4075_5812a533-90fa-6e6d-e053-2a91aa0afc0c 68071-4075 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA073192 NuCare pharmceuticals,Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 68071-4076_5812a533-90d3-6e6d-e053-2a91aa0afc0c 68071-4076 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20170330 ANDA ANDA077797 NuCare Pharmaceuticals,Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68071-4077_58252f15-4869-3061-e053-2a91aa0a2320 68071-4077 HUMAN OTC DRUG Allergy relief Loratadine TABLET ORAL 20080101 ANDA ANDA076471 NuCare Pharmaceuticals,Inc. LORATADINE 10 mg/1 N 20181231 68071-4078_5828e241-9407-7341-e053-2991aa0a41f7 68071-4078 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride E-R CAPSULE, COATED, EXTENDED RELEASE ORAL 20160118 ANDA ANDA203002 NuCare Pharmaceuticals,Inc. POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68071-4079_58899a4d-bf32-1c17-e053-2a91aa0afcf8 68071-4079 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 NuCare Pharmaceuticals,Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-4080_588bf311-b700-d6f1-e053-2a91aa0ae0f8 68071-4080 HUMAN PRESCRIPTION DRUG clotrimazole and betamethasone dipropionate clotrimazole and betamethasone dipropionate CREAM TOPICAL 20070103 ANDA ANDA076002 NuCare Pharmaceuticals,Inc. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-4081_588a8ffd-1bd7-ae6c-e053-2a91aa0af15e 68071-4081 HUMAN OTC DRUG ASPIRIN 325 MG EC ASPIRIN TABLET ORAL 20151101 OTC MONOGRAPH FINAL part343 NuCare Pharmaceuticals,Inc. ASPIRIN 325 mg/1 N 20181231 68071-4082_588a62df-3e5b-15c2-e053-2991aa0a30bc 68071-4082 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20160503 ANDA ANDA091368 NuCare Pharmaceuticals,Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68071-4083_617d1957-c415-7f34-e053-2a91aa0a3fe0 68071-4083 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CIV CAPSULE ORAL 19900930 ANDA ANDA071620 NuCare Pharmaceuticals,Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20191231 68071-4084_589e053b-a968-fc42-e053-2a91aa0aa324 68071-4084 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 NuCare Pharmaceuticals,Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68071-4085_589dc76d-c348-0589-e053-2991aa0a2520 68071-4085 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 NuCare Pharmaceuticals,Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-4086_58b1fa9d-a2eb-6dc6-e053-2991aa0a3741 68071-4086 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 NuCare Pharmaceuticals,Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-4087_58ffd228-a6ab-25bf-e053-2991aa0ab998 68071-4087 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 NuCare Pharmaceuticals,Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-4088_5900270c-1926-79c5-e053-2a91aa0ac375 68071-4088 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20170330 ANDA ANDA207378 NuCare Pharmaceuticals,Inc. FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68071-4089_5904f126-e8ec-a892-e053-2991aa0aef0f 68071-4089 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101206 NDA AUTHORIZED GENERIC NDA021774 NuCare Pharmaceuticals,Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 68071-4090_58fffcbb-43af-40ab-e053-2991aa0a1408 68071-4090 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 NuCare Pharmaceuticals,Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-4091_58ff9412-5fdf-52bd-e053-2991aa0a689f 68071-4091 HUMAN PRESCRIPTION DRUG indomethacin indomethacin CAPSULE ORAL 20160721 ANDA ANDA090403 NuCare Pharmaceuticals,Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-4092_58ffb850-d587-0dc0-e053-2a91aa0a1015 68071-4092 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 NuCare Pharmaceuticals,Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68071-4093_590341c9-70b2-2d97-e053-2991aa0ae223 68071-4093 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 NuCare Pharmaceuticals,Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-4094_5904f126-e831-a892-e053-2991aa0aef0f 68071-4094 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 NuCare Pharmaceuticals,Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68071-4095_590668e3-e0c6-10d1-e053-2991aa0aff74 68071-4095 HUMAN OTC DRUG GoodSense Artifical Tears Polyvinyl alcohol, and Povidone SOLUTION/ DROPS OPHTHALMIC 20160404 OTC MONOGRAPH FINAL part349 NuCare Pharmaceuticals,Inc. POLYVINYL ALCOHOL; POVIDONE .05; .06 g/mL; g/mL N 20181231 68071-4096_592d1cfd-8046-3cd3-e053-2991aa0a88f2 68071-4096 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 NuCare Pharmaceuticals,Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-4097_5927fcff-9d1b-8322-e053-2991aa0ad289 68071-4097 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 NuCare Pharmaceuticals,Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68071-4098_598e7ea2-4f1d-1ffd-e053-2991aa0a42d8 68071-4098 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 NuCare Pharmaceuticals,Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-4099_598e9653-9332-3bfe-e053-2a91aa0afcbe 68071-4099 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN TABLET, FILM COATED ORAL 20140111 ANDA ANDA203244 NuCare Pharmaceuticals,Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-4101_5a19482c-311b-e731-e053-2991aa0ab862 68071-4101 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 NuCare Pharmaceuticals,Inc. LEVOFLOXACIN 250 mg/1 N 20181231 68071-4102_5a314c42-3696-7669-e053-2a91aa0ac67a 68071-4102 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 NuCare Pharmaceuticals,Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68071-4103_60f5cfcf-cdb3-0e45-e053-2991aa0ae85a 68071-4103 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim SOLUTION OPHTHALMIC 19980416 ANDA ANDA064211 NuCare Pharmaceuticals,Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 68071-4104_5a5a4040-5396-54ac-e053-2991aa0aa4ab 68071-4104 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 NuCare Pharmaceuticals,Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68071-4105_5a5a337d-745b-2033-e053-2a91aa0a53f6 68071-4105 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070409 ANDA ANDA040597 NuCare Pharmaceuticals,Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68071-4106_5b362e9f-6217-cdbb-e053-2a91aa0a20ca 68071-4106 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 NuCare Pharmaceuticals,Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68071-4107_5b4e1ea0-d65f-6929-e053-2991aa0a626e 68071-4107 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET, FILM COATED ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals,Inc. ACETAMINOPHEN 500 mg/1 N 20181231 68071-4108_5b49b111-1f36-15a9-e053-2a91aa0aa029 68071-4108 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 NuCare Pharmaceuticals,Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68071-4109_5aabeb58-3436-6fbc-e053-2a91aa0a4124 68071-4109 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 NuCare Pharmaceuticals,Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-4110_5abd662a-51e2-8a78-e053-2a91aa0ae06f 68071-4110 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20030702 ANDA ANDA065095 NuCare Pharmaceuticals,Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68071-4111_5abf8c5c-e9ca-3b59-e053-2a91aa0ae394 68071-4111 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20110608 ANDA ANDA090480 NuCare Pharmaceuticals,Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 68071-4112_5ae2ee9f-b4f2-e2bd-e053-2991aa0ab0e3 68071-4112 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 19871101 ANDA ANDA087499 NuCare Pharmaceuticals,Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 68071-4113_5b1f8da0-bcc5-a031-e053-2991aa0a60e8 68071-4113 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100123 ANDA ANDA075350 Nucare Pharmaceuticals,Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-4114_5b1f6fd1-2d8b-0516-e053-2991aa0a31ef 68071-4114 HUMAN OTC DRUG MINTOX MAXIMUM STRENGTH aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 NuCare Pharmaceuticals,Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 68071-4115_5bacb621-1262-25d9-e053-2991aa0afa3b 68071-4115 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 NuCare Pharmaceuticals,Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-4116_5b49b111-1f41-15a9-e053-2a91aa0aa029 68071-4116 HUMAN OTC DRUG New Terocin Methyl Salicylate, Capsaicin, and Menthol LOTION TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 NuCare Pharmaceuticals,Inc. METHYL SALICYLATE; CAPSAICIN; MENTHOL 25; .025; 10 g/100mL; g/100mL; g/100mL N 20181231 68071-4117_5b4c2096-d612-86ff-e053-2991aa0a2715 68071-4117 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 NuCare Pharmaceuticals,Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-4118_5b6f4839-1f2c-94b2-e053-2a91aa0a85e0 68071-4118 HUMAN OTC DRUG Plus Pharma Pain Reliever,Fever Reducer ACETAMINOPHEN TABLET ORAL 20060327 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals,Inc. ACETAMINOPHEN 325 mg/1 N 20181231 68071-4119_5babcfcf-331c-5db9-e053-2a91aa0aaf89 68071-4119 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20101115 ANDA ANDA076003 NuCare Pharmaceuticals,Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68071-4120_5b70690f-3d52-ebb3-e053-2a91aa0ae6fe 68071-4120 HUMAN PRESCRIPTION DRUG alendronate sodium alendronate sodium TABLET ORAL 20080804 ANDA ANDA076984 NuCare Pharmaceuticals,Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 68071-4121_5bac07e0-1527-11bd-e053-2991aa0a46d5 68071-4121 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20110217 ANDA ANDA077421 NuCare Pharmaceuticals,Inc. LORATADINE 5 mg/5mL N 20181231 68071-4122_5bab9397-b9f4-d309-e053-2991aa0a6612 68071-4122 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 NuCare Pharmaceuticals,Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68071-4123_5c615e6e-1eff-7eb0-e053-2a91aa0ac976 68071-4123 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 NuCare Pharmaceuticals,Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-4124_5c627a52-e4cb-7103-e053-2a91aa0ae13f 68071-4124 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950227 ANDA ANDA074223 NuCare Pharmaceuticals,Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-4125_5c6176ec-ad59-ee78-e053-2991aa0a663d 68071-4125 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20121024 ANDA ANDA077027 NuCare Pharmaceuticals,Inc. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 68071-4126_5c60df47-58d2-5226-e053-2a91aa0a1646 68071-4126 HUMAN OTC DRUG Take Action Levonorgestrel TABLET ORAL 20140217 NDA AUTHORIZED GENERIC NDA021998 NuCare Pharmaceuticals,Inc. LEVONORGESTREL 1.5 mg/1 N 20181231 68071-4127_5c602bb8-33d1-7839-e053-2a91aa0aabf5 68071-4127 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088238 NuCare Pharmaceuticals,Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-4128_5c664215-758e-a7a8-e053-2a91aa0a570e 68071-4128 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 20020301 OTC MONOGRAPH NOT FINAL part334 NuCare Pharmaceuticals,Inc. MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 68071-4129_5c752888-535e-7038-e053-2a91aa0a6c5a 68071-4129 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 NuCare Pharmaceuticalsf,Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-4130_5c7509bd-94f7-1920-e053-2991aa0a7616 68071-4130 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20070518 ANDA ANDA077179 NuCare Pharmaceuticals,Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-4131_5c7819eb-2bce-fc25-e053-2991aa0af451 68071-4131 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20090406 NDA NDA018832 NuCare Pharmaceuticals,Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 68071-4132_5c8ffae3-3b3f-197e-e053-2a91aa0a59e3 68071-4132 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 19961204 ANDA ANDA040159 NuCare Pharmaceuticals,Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68071-4133_5cc56d2b-1f56-be93-e053-2991aa0a94d9 68071-4133 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031119 ANDA ANDA076467 NuCare Pharmaceuticals,Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-4134_5cc511e4-3e7e-70d6-e053-2a91aa0a8044 68071-4134 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20151106 ANDA ANDA202894 NuCare Pharmaceuticals,Inc. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-4135_5ccb38b3-4bfb-75d8-e053-2a91aa0acbc8 68071-4135 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 NuCare Pharmaceuticals,Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-4136_5ccb352e-5557-a1b8-e053-2991aa0aac93 68071-4136 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-4137_5cf1149a-a4c3-0cc4-e053-2991aa0ae258 68071-4137 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SOLUTION ORAL 20060426 ANDA ANDA040643 NuCare Pharmaceuticals,Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68071-4138_5cdca9bd-7043-142a-e053-2991aa0a9ca6 68071-4138 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA076999 NuCare Pharmaceuticals,Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68071-4139_5d04ba66-5bc1-082f-e053-2991aa0a3e16 68071-4139 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20040507 NDA AUTHORIZED GENERIC NDA019992 NuCare Pharmaceuticals,Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68071-4140_5cdd3ad7-93b7-28fb-e053-2a91aa0ad8e1 68071-4140 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090123 ANDA ANDA075410 NuCare Pharmaceuticals,Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-4141_5cde977a-9721-0b2f-e053-2a91aa0a4959 68071-4141 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68071-4142_5cdfba1e-717a-a2ee-e053-2991aa0adce9 68071-4142 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20160601 ANDA ANDA206079 NuCare Pharmceuticals,Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68071-4143_5cdfdcb3-ea2b-63b9-e053-2a91aa0ae17f 68071-4143 HUMAN OTC DRUG Rabofen DM Guaifenesin and Dextromethorphan Hydrobromide SOLUTION ORAL 20040101 OTC MONOGRAPH FINAL part341 NuCare Pharmaceuticals,Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 68071-4144_5cf0d587-c1dc-0293-e053-2991aa0a83c2 68071-4144 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 20010918 ANDA ANDA075788 NuCare Pharmaceuticals,Inc. ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-4145_5cf14c47-aeb3-6a3c-e053-2991aa0add0a 68071-4145 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20040813 ANDA ANDA065098 NuCare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-4146_5d01fd9f-4913-b7dd-e053-2a91aa0a7169 68071-4146 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20090123 ANDA ANDA075410 NuCare Pharmaceuticals,Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68071-4147_5d027af6-a9fe-f886-e053-2a91aa0a8cc0 68071-4147 HUMAN OTC DRUG Rugby Travel Sickness Meclizine HCl, 25 mg Each (Antiemetic) Meclizine HCl TABLET, CHEWABLE ORAL 20140819 OTC MONOGRAPH FINAL part336 NuCare Pharmaceuticals,Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 68071-4148_5d0767c7-cfbf-af1d-e053-2991aa0a67d3 68071-4148 HUMAN OTC DRUG Aspirin E-C Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals,Inc. ASPIRIN 81 mg/1 N 20181231 68071-4149_5d7ef1d2-d966-7b01-e053-2991aa0a1311 68071-4149 HUMAN OTC DRUG Rugby Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20150910 OTC MONOGRAPH FINAL part349 NuCare Pharmaceuticals,Inc. POLYVINYL ALCOHOL 14 mg/mL N 20181231 68071-4150_5d7c0725-9ad8-8474-e053-2991aa0afa05 68071-4150 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-4151_5d7ef1d2-d971-7b01-e053-2991aa0a1311 68071-4151 HUMAN OTC DRUG acetaminophen for children Acetaminophen SUPPOSITORY RECTAL 20101214 ANDA ANDA070607 NuCare Pharmaceutiacals,Inc. ACETAMINOPHEN 120 mg/1 N 20181231 68071-4152_5d819b84-a7f5-2d26-e053-2991aa0a8ab5 68071-4152 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060130 ANDA ANDA077651 NuCare Pharmaceuticals,Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68071-4153_5d94017c-de54-6041-e053-2a91aa0a121c 68071-4153 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20161208 ANDA ANDA206955 NuCare Pharmaceuticals,Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68071-4154_5da6a6c1-aa35-3762-e053-2991aa0ac947 68071-4154 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE Tramadol hydrochloride TABLET ORAL 20150522 ANDA ANDA091498 NuCare Pharmaceuticals,Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68071-4155_5e0b7059-8330-64f3-e053-2991aa0a7443 68071-4155 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 NuCare Pharmaceuticals,Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68071-4156_5e1d9e90-fbe6-1ce9-e053-2a91aa0a89b4 68071-4156 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20080116 ANDA ANDA077570 NuCare Pharmaceuticals,Inc. FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-4157_5e21cb89-20a6-435d-e053-2a91aa0ad9c3 68071-4157 HUMAN PRESCRIPTION DRUG Tamsulosin hydrochloride Tamsulosin hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078801 NuCare Pharmaceuticals,Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68071-4158_5e7113aa-e644-08c8-e053-2991aa0aa564 68071-4158 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000228 ANDA ANDA075492 NuCare Pharmaceuticals,Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68071-4159_5e35e3b9-7d7a-b32a-e053-2991aa0ae9c0 68071-4159 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160523 ANDA ANDA091617 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-4160_5e71d180-1e84-e8ff-e053-2991aa0a3f4a 68071-4160 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20080429 ANDA ANDA065435 NuCare Pharmaceuticals,Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-4161_5e727fc7-4454-6b14-e053-2a91aa0a5ff6 68071-4161 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 NuCare Pharmaceuticals,Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 68071-4162_5e95c38a-981f-9900-e053-2a91aa0a7e0d 68071-4162 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine ciclopirox olamine CREAM TOPICAL 20050412 ANDA ANDA076790 NuCare Pharmaceuticals,Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 68071-4163_5efe7b9b-4b8a-5040-e053-2991aa0a036b 68071-4163 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063181 NuCare Pharmaceuticals,Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68071-4164_5f2241f5-eb80-1bd6-e053-2a91aa0a6cd4 68071-4164 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 NuCare Pharmaceuticals,Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68071-4165_5f12c60a-fc2d-7c89-e053-2991aa0ab7a7 68071-4165 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110131 ANDA ANDA090404 NuCare Pharmaceuticals,Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68071-4166_5f12c60a-fc2e-7c89-e053-2991aa0ab7a7 68071-4166 HUMAN OTC DRUG ACETAMINOPHEN 325 MG ACETAMINOPHEN TABLET ORAL 20151101 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals,Inc. ACETAMINOPHEN 325 mg/1 N 20181231 68071-4167_5f26924c-8b03-0baa-e053-2991aa0acce0 68071-4167 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20131108 ANDA ANDA091643 NuCare Pharmaceuticals,Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68071-4168_5f4b2ee4-c8b0-df75-e053-2a91aa0a62fc 68071-4168 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 20170417 ANDA ANDA208848 NuCare Pharmaceuitcals,Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-4169_5f3ab29d-e5d2-6206-e053-2a91aa0a95be 68071-4169 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 NuCare Pharmaceuticals,Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-4170_5f4eb99a-f4a1-350d-e053-2991aa0a40d0 68071-4170 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20071201 ANDA ANDA065191 NuCare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANIC ACID 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-4171_5f4e2d0b-b1d4-ec59-e053-2991aa0ad1d7 68071-4171 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-4172_5f86e792-3263-4ee6-e053-2991aa0a54a0 68071-4172 HUMAN OTC DRUG acetaminophen for children Acetaminophen SUPPOSITORY RECTAL 20101214 ANDA ANDA070607 NuCare Pharmaceuticals,Inc. ACETAMINOPHEN 120 mg/1 N 20181231 68071-4173_5f894cb8-5829-fc2d-e053-2991aa0a1500 68071-4173 HUMAN OTC DRUG Rugby Travel Sickness Meclizine HCl, 25 mg Each (Antiemetic) Meclizine HCl TABLET, CHEWABLE ORAL 20140819 OTC MONOGRAPH FINAL part336 NuCare Pharmaceuticals,Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 68071-4174_5f9c25b1-67d1-11ae-e053-2a91aa0ad8f4 68071-4174 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 19951229 ANDA ANDA064053 NuCare Pharmaceuticals,Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-4175_5f9f3747-f716-8d05-e053-2a91aa0a23dc 68071-4175 HUMAN PRESCRIPTION DRUG FOLIC ACID folic acid TABLET ORAL 20150804 ANDA ANDA204418 NuCare Pharmaceuticals,Inc. FOLIC ACID 1 mg/1 N 20181231 68071-4176_5fae2052-0b3b-5eb8-e053-2991aa0a7994 68071-4176 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 NuCare Pharmaceuticals,Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-4177_5fc4ab7e-cee6-30d7-e053-2a91aa0ae81b 68071-4177 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA062703 NuCare Pharmaceuticals,Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68071-4179_5fc62abc-8583-34e4-e053-2991aa0a09cd 68071-4179 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20171116 ANDA ANDA205519 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-4180_5fc7d050-4076-4263-e053-2a91aa0aeae4 68071-4180 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 NuCare Pharmaceuticals,Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68071-4181_5fc7d75b-f2da-4ba3-e053-2a91aa0aceb9 68071-4181 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071136 NuCare Pharmaceuticals,Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68071-4182_5fc7b20d-a48d-10d7-e053-2a91aa0ae78e 68071-4182 HUMAN PRESCRIPTION DRUG fenofibrate fenofibrate TABLET ORAL 20140923 ANDA ANDA090715 NuCare Pharmaceuticals,Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68071-4183_60130294-4596-7497-e053-2991aa0abb94 68071-4183 HUMAN PRESCRIPTION DRUG VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20151031 ANDA ANDA206083 NuCare Pharmaceuticals,Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-4184_60180100-4f43-2aad-e053-2991aa0a4494 68071-4184 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 NuCare Pharmaceuticals,Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-4185_6027cff7-dfd7-5e5f-e053-2a91aa0ab548 68071-4185 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20170426 ANDA ANDA205300 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68071-4186_602d7910-8426-c5e0-e053-2991aa0a80d6 68071-4186 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 20170417 ANDA ANDA208848 NuCare Pharmaceuticals,Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-4187_60679870-7988-db7a-e053-2a91aa0a1dbf 68071-4187 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160523 ANDA ANDA091617 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68071-4188_6064b394-5c91-60c5-e053-2991aa0acf48 68071-4188 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20071030 ANDA ANDA077002 NuCare Pharmaceuticals,Inc. DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 68071-4189_605220b0-cd5a-7cb9-e053-2a91aa0ac182 68071-4189 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20061228 ANDA ANDA065334 NuCare Pharmaceuticals,Inc. AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-4190_6052a964-eecc-a4be-e053-2a91aa0aaa19 68071-4190 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 NuCare Pharmaceuticals,Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-4191_60683674-eae5-2745-e053-2991aa0a81e8 68071-4191 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON INJECTION INTRAMUSCULAR; INTRAVENOUS 20120615 ANDA ANDA079224 NuCare Pharmaceuticals,Inc. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-4192_6054ff44-b295-8581-e053-2991aa0a9e63 68071-4192 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20070326 ANDA ANDA065378 NuCare Pharmaceuticals,Inc. AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-4193_6065e359-c1ea-4768-e053-2a91aa0ab884 68071-4193 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021121 ANDA ANDA065093 NuCare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-4194_60b75ab4-59d9-7515-e053-2a91aa0a74da 68071-4194 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 NuCare Pharmaceuticals,Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68071-4195_60b6487b-761c-1c43-e053-2a91aa0a1fd9 68071-4195 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 NuCare Pharmaceuticals,Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68071-4196_60ca37b0-b7a3-4287-e053-2991aa0af406 68071-4196 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 19900930 ANDA ANDA061931 NuCare Pharmaceuticals,Inc. AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68071-4197_60cd0973-f74f-2b70-e053-2a91aa0a4361 68071-4197 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 NuCare Pharmaceuticals,Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68071-4198_60dce1ad-1296-396d-e053-2a91aa0a670f 68071-4198 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20100202 ANDA ANDA076820 NuCare Pharmaceuticals,Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68071-4199_6140f008-7530-1555-e053-2a91aa0ae176 68071-4199 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20101104 ANDA ANDA077839 NuCare Pharmaceuticals,Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68071-4200_6143b4b4-7b3a-5be3-e053-2991aa0a5d5c 68071-4200 HUMAN OTC DRUG Adult Low Dose Enteric Coated Aspirin Aspirin TABLET, COATED ORAL 20000701 OTC MONOGRAPH FINAL part343 NuCare Pharmaceuticals,Inc. ASPIRIN 81 mg/1 N 20181231 68071-4201_614102db-a551-0534-e053-2991aa0a1b23 68071-4201 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 NuCare Pharmaceuticals,Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68071-4202_6145a2ee-45d0-5f41-e053-2a91aa0a4a10 68071-4202 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 NuCare Pharmaceuticals,Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68071-4203_616937e6-f802-0f8a-e053-2991aa0aed72 68071-4203 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 19991027 ANDA ANDA064134 NuCare Pharmaceuticals,Inc. TOBRAMYCIN; DEXAMETHASONE 3; 1 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68071-4204_617d0bad-7530-1b76-e053-2a91aa0a21d9 68071-4204 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021121 ANDA ANDA065093 NuCare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-4205_6182a65c-71cb-dfe4-e053-2991aa0a0a52 68071-4205 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021121 ANDA ANDA065093 NuCare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68071-4206_6182c593-4254-0326-e053-2991aa0a4ad0 68071-4206 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 NuCare Pharmaceuticals,Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-4207_618372ad-36da-f6c2-e053-2a91aa0aa4b6 68071-4207 HUMAN OTC DRUG Simethicone Simethicone SUSPENSION/ DROPS ORAL 20101201 OTC MONOGRAPH FINAL part332 NuCare Pharmaceuticals,Inc. DIMETHICONE 20 mg/.3mL N 20191231 68071-4208_6182bea6-1639-c6f9-e053-2a91aa0a5f51 68071-4208 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 NuCare Pharmaceuticals,Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68071-4209_61e2a3ad-4633-a586-e053-2991aa0a7656 68071-4209 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021127 ANDA ANDA065117 NuCare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 68071-4210_61f93369-375d-276e-e053-2991aa0ad11d 68071-4210 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 NuCare Pharmaceuticals,Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68071-4211_61fb3ced-b557-421b-e053-2991aa0a5208 68071-4211 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 NuCare Pharmaceuticals,Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 68071-4212_61fb3ced-b59a-421b-e053-2991aa0a5208 68071-4212 HUMAN PRESCRIPTION DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20160421 ANDA ANDA205606 NuCare Pharmaceuticals,Inc. ESOMEPRAZOLE MAGNESIUM DIHYDRATE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 68071-4213_61fb6a54-90b3-7c48-e053-2991aa0a16fe 68071-4213 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE ORAL 20151019 ANDA ANDA203636 NuCare Pharmaceuticals,Inc. ESOMEPRAZOLE MAGNESIUM 20 1/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 68071-4214_620fa9c8-fd79-7a96-e053-2991aa0a7c34 68071-4214 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150818 ANDA ANDA065398 NuCare Pharmaceuticals,Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 68071-4215_62101b84-df0c-7996-e053-2a91aa0a6376 68071-4215 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 19821001 ANDA ANDA085828 NuCare Pharmaceuticals,Inc. SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20191231 68071-4216_62485a53-f04d-2d9c-e053-2a91aa0a4728 68071-4216 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA063065 NuCare Pharmaceuticals,Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 68071-4217_625f253d-c6d3-913e-e053-2a91aa0a3758 68071-4217 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20080701 ANDA ANDA074916 NuCare Pharmaceuticals,Inc. IBUPROFEN 100 mg/5mL N 20191231 68071-4218_625f707a-94b3-0221-e053-2a91aa0aac23 68071-4218 HUMAN OTC DRUG STOOL SOFTNER Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20160301 OTC MONOGRAPH NOT FINAL part334 NuCare Pharmaceutiacals,Inc. DOCUSATE SODIUM 100 mg/1 N 20191231 68071-4219_624c81a7-282b-95be-e053-2991aa0a6b44 68071-4219 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20161027 ANDA ANDA071500 NuCare Pharmaceuticals Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 68071-4220_625a9656-1061-761b-e053-2991aa0a857d 68071-4220 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68071-4221_6260c642-40b5-19cd-e053-2a91aa0a8f14 68071-4221 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20000517 ANDA ANDA075633 NuCare Pharmaceuticals,Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 68071-4222_625f707a-94f1-0221-e053-2a91aa0aac23 68071-4222 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160523 ANDA ANDA091617 NuCare Pharmaceutiacals,Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 68071-4223_6282b617-9069-0c3d-e053-2991aa0a40ee 68071-4223 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 NuCare Pharmaceuticals,Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 68071-4224_6285c4f2-c13c-49a9-e053-2991aa0a2b03 68071-4224 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20170301 ANDA ANDA204755 NuCare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 68071-4225_62736c55-d92d-be0f-e053-2991aa0a103b 68071-4225 HUMAN OTC DRUG clotrimazole Clotrimazole CREAM TOPICAL 20110603 OTC MONOGRAPH FINAL part333C NuCare Pharmaceuticals,Inc. CLOTRIMAZOLE 1 g/100g N 20191231 68071-4226_62823019-08b3-5760-e053-2991aa0abdee 68071-4226 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20101104 ANDA ANDA077839 NuCare Pharmaceuticals,Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 68071-4227_62969057-f950-ab40-e053-2991aa0a2844 68071-4227 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19930501 ANDA ANDA063065 NuCare Pharmaceuticals,Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 68071-4228_6296e2ed-334d-b9af-e053-2991aa0aae0c 68071-4228 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 NuCare Pharmaceuticals,Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 68071-4229_6296e2ed-336c-b9af-e053-2991aa0aae0c 68071-4229 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 NuCare Pharmaceuticals,Inc. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20191231 68071-4230_629b9c85-8c4f-34e1-e053-2a91aa0a5dcc 68071-4230 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150818 ANDA ANDA065398 NuCare Pharmaceuticals,Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 68071-4231_629b4c3c-9c39-2e80-e053-2991aa0aaaac 68071-4231 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 NuCare Pharmaceuticals,Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68071-4232_62d569b8-bb35-0e06-e053-2a91aa0a2ae1 68071-4232 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 NuCare Pharmaceuticals,Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 68071-4233_62d80793-ada2-70c3-e053-2a91aa0acc85 68071-4233 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20070412 ANDA ANDA065326 NuCare Pharmaceuticals,Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 68071-4234_6300449b-83ac-cf7a-e053-2991aa0a4a51 68071-4234 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 19960708 ANDA ANDA074249 NuCare Pharmaceuticals,Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 68071-4235_6301febb-01ab-1af5-e053-2991aa0aa309 68071-4235 HUMAN PRESCRIPTION DRUG Ciprofloxacin Hydrochloride Ciprofloxacin Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20040507 NDA AUTHORIZED GENERIC NDA019992 NuCare Pharmaceuticals,Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 68071-4236_63026f19-2437-618b-e053-2a91aa0a9be0 68071-4236 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20131004 ANDA ANDA065429 NuCare Pharmaceuticals,Inc. CEFDINIR MONOHYDRATE 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 68071-4237_630fec2e-30e8-3c1b-e053-2a91aa0aba11 68071-4237 HUMAN PRESCRIPTION DRUG Dutasteride dutasteride CAPSULE, LIQUID FILLED ORAL 20151125 ANDA ANDA204292 NuCare Pharmaceuticals,Inc. DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20191231 68071-4238_63145927-4053-39c1-e053-2a91aa0a72dc 68071-4238 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 NuCare Pharmaceuticals,Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 68071-4239_63269e96-cf68-e9bb-e053-2991aa0ab3ef 68071-4239 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20090817 ANDA ANDA076921 NuCare Pharmaceuticals,Inc. MIRTAZAPINE 30 mg/1 N 20191231 68071-4241_6328b255-ca2e-c519-e053-2a91aa0a7933 68071-4241 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20171205 ANDA ANDA090705 NuCare Pharmaceuticals,Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 68071-4242_636556f6-2988-984f-e053-2991aa0a201a 68071-4242 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET ORAL 20101225 NDA AUTHORIZED GENERIC NDA018602 NuCare Pharmaceuticals,Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 68071-4243_6365b2d6-2338-70c0-e053-2a91aa0aa960 68071-4243 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20151230 ANDA ANDA090796 NuCare Pharmaceuticals,Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68071-4244_6374d282-e7f5-59ee-e053-2991aa0a97cc 68071-4244 HUMAN PRESCRIPTION DRUG Losartan potassium Losartan potassium TABLET, FILM COATED ORAL 20120510 ANDA ANDA202230 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 68071-4245_63665de7-8416-651f-e053-2991aa0ac2bb 68071-4245 HUMAN OTC DRUG Tolnaftate TOLNAFTATE CREAM TOPICAL 20100211 OTC MONOGRAPH FINAL part333C NuCare Pharmaceuticals,Inc. TOLNAFTATE 10 mg/g N 20191231 68071-4247_637737b7-e933-7536-e053-2991aa0af6ec 68071-4247 HUMAN OTC DRUG My Choice TM levonorgestrel TABLET ORAL 20170512 ANDA ANDA202635 NuCare Pharmaceuticals,Inc. LEVONORGESTREL 1.5 mg/1 N 20191231 68071-4248_6378ef61-9dbd-4eb0-e053-2991aa0a8f8b 68071-4248 HUMAN PRESCRIPTION DRUG Losartan potassium Losartan potassium TABLET, FILM COATED ORAL 20120510 ANDA ANDA202230 NuCare Pharmaceuticals,Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 68071-4249_63779927-da9d-7641-e053-2a91aa0a87fc 68071-4249 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20041221 ANDA ANDA076679 NuCare Pharmaceuticals,Inc. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 68071-4250_63880f11-aecf-b542-e053-2a91aa0a52ff 68071-4250 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 NuCare Pharmaceuticals,Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68071-4251_638d86ab-986c-59ed-e053-2a91aa0a98ee 68071-4251 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20101020 ANDA ANDA078925 NuCare Pharmaceuticals,Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 68071-4252_638d5cff-0350-1f21-e053-2a91aa0a0a65 68071-4252 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 NuCare Pharmaceuticals,Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68071-4253_63b37ddc-d629-3dce-e053-2991aa0a21f8 68071-4253 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 NuCare Pharmaceuticals,Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68071-4254_6400e119-166f-534b-e053-2a91aa0a71be 68071-4254 HUMAN OTC DRUG Aspirin 81 mg Enteric Coated Aspirin TABLET ORAL 20151101 OTC MONOGRAPH FINAL part343 NuCare Pharmaceuticals,Inc. ASPIRIN 81 mg/1 N 20191231 68071-4255_63f23043-2f21-48ba-e053-2a91aa0a1ea9 68071-4255 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 NuCare Pharmaceuticals,Inc. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 68071-4256_63f30121-a107-3adf-e053-2a91aa0a85b1 68071-4256 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021127 ANDA ANDA065117 NuCare Pharmaceuticals,Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 68071-4257_63f26644-b7ac-98c1-e053-2a91aa0af5d3 68071-4257 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 NuCare Pharmaceuticals,Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 68071-4258_63f271bb-4fb2-bd08-e053-2a91aa0aebb6 68071-4258 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170322 ANDA ANDA040749 NuCare Pharmaceuticals,Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 68071-4259_6405f392-f87e-44a6-e053-2a91aa0ae278 68071-4259 HUMAN OTC DRUG ACETAMINOPHEN 325 MG ACETAMINOPHEN TABLET ORAL 20151101 OTC MONOGRAPH NOT FINAL part343 NuCare Pharmaceuticals,Inc. ACETAMINOPHEN 325 mg/1 N 20191231 68071-4260_641729a3-6dd4-3a2f-e053-2991aa0a015e 68071-4260 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 NuCare Pharmaceuticals,Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 68071-4261_6415faa3-e5c5-e107-e053-2991aa0ad022 68071-4261 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20150814 ANDA ANDA200981 NuCare Pharmaceuticals,Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 68071-4262_6415d00f-3141-b354-e053-2991aa0a9f93 68071-4262 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040194 NuCare Pharmaceuticals,Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 68071-4263_643f9e50-5c9c-73bb-e053-2991aa0aa4c3 68071-4263 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20150601 ANDA ANDA205085 NuCare Pharmaceuticals,Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 68071-4264_64405719-6fa9-6d77-e053-2991aa0a7af4 68071-4264 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20151123 ANDA ANDA204019 NuCare Pharmaceuticals,Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20191231 68071-4265_64434256-5fce-3a23-e053-2991aa0afee2 68071-4265 HUMAN PRESCRIPTION DRUG fenofibrate fenofibrate TABLET ORAL 20140813 ANDA ANDA090715 NuCare Pharmaceuticals,Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20191231 68071-4266_648fa0ba-3f6f-1817-e053-2991aa0af589 68071-4266 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 NuCare Pharmaceuticals,Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 68071-4267_648edfe5-cb91-6dca-e053-2a91aa0ae14f 68071-4267 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 NuCare Pharmaceuticals,Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68071-4268_648ed84e-0c85-63d6-e053-2991aa0a8d96 68071-4268 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120518 ANDA ANDA090494 NuCare Pharmaceuticals,Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20191231 68071-4269_648edfe5-cba3-6dca-e053-2a91aa0ae14f 68071-4269 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20150814 ANDA ANDA200981 NuCare Pharmaceuticals,Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 68071-4270_648f6ddf-8513-2f83-e053-2991aa0ac453 68071-4270 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080417 ANDA ANDA078321 NuCare Pharmaceuticals,Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 68071-4271_648f3151-de36-463b-e053-2a91aa0a6508 68071-4271 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 NuCare Pharmaceuticals,Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68078-000_e3fc627f-6114-4381-9c9c-9b0a02c195da 68078-000 HUMAN OTC DRUG SPF 20 Loose Mineral Foundation Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 186; 59 mg/g; mg/g E 20171231 68078-001_10408159-7189-4739-be8a-18e942a666b6 68078-001 HUMAN OTC DRUG Sunforgettable Loose Mineral Sunscreen SPF 30 Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20151005 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 210; 118 mg/g; mg/g E 20171231 68078-002_e3780aea-7272-43e4-95c9-fb5bf493d93c 68078-002 HUMAN OTC DRUG Sunforgettable Brush On Mineral Sunscreen SPF 50 Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20151005 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 239; 241 mg/g; mg/g E 20171231 68078-003_8c939a5d-d98b-4959-9634-718a2361213b 68078-003 HUMAN OTC DRUG Even Up Sunscreen SPF 50 Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20151005 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 116; 86 mg/mL; mg/mL E 20171231 68078-004_73934e01-5f3d-4a20-b54f-bf289f8195b7 68078-004 HUMAN OTC DRUG Sunforgettable Tint du Soleil Foundation SPF 30 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20151005 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 48; 67 mg/mL; mg/mL E 20171231 68078-005_5ce4441f-e131-4a05-9d33-5fd68e870fa0 68078-005 HUMAN OTC DRUG Skin Brightening Face Primer SPF 20 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20151005 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 25; 39 mg/mL; mg/mL E 20171231 68078-006_8dd5ea47-fc84-44cf-bd1d-327b49cc39b4 68078-006 HUMAN OTC DRUG Skin Bronzing Face Primer SPF 20 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20151005 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 50; 68 mg/mL; mg/mL E 20171231 68078-007_33204690-00cd-47e3-a617-fa998a32dbed 68078-007 HUMAN OTC DRUG Skin Calming Face Primer SPF 20 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20151005 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 54; 54 mg/mL; mg/mL E 20171231 68078-008_2cdc3325-50d4-4d8c-823b-2b99d962a45d 68078-008 HUMAN OTC DRUG Skin Mattifying Face Primer SPF 20 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20151005 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 28; 53 mg/mL; mg/mL E 20171231 68078-009_0aa00f2b-6fd8-40c8-a575-4eff4e2c8ee1 68078-009 HUMAN OTC DRUG Skin Balancing Face Primer SPF 20 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20151005 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 21; 41 mg/mL; mg/mL E 20171231 68078-010_2ee822aa-d34b-4134-b5ba-acdbf09ad4cd 68078-010 HUMAN OTC DRUG Sunforgettable Face Primer SPF 30 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20151005 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 54; 54 mg/mL; mg/mL E 20171231 68078-011_60552df8-8743-403d-8420-5bbf7f93e6ae 68078-011 HUMAN OTC DRUG Sunforgettable Eyescreen SPF 30 Sunscreen Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20151005 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 116; 118 mg/g; mg/g E 20171231 68078-012_5339322f-0e6a-401f-b95b-5bb273320f19 68078-012 HUMAN OTC DRUG Sunforgettable Lip Shine SPF 35 Sunscreen Zinc Oxide LIQUID TOPICAL 20151005 OTC MONOGRAPH NOT FINAL part352 Colorescience ZINC OXIDE 50 mg/mL E 20171231 68078-013_9724a860-2c3c-4293-8ca9-2f0838728254 68078-013 HUMAN OTC DRUG Natural Finish Pressed Foundation SPF 20 Sunscreen Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 212; 120 mg/g; mg/g E 20171231 68078-014_3dd74b53-c999-4d10-b1bf-87310cb60fbb 68078-014 HUMAN OTC DRUG Mineral Corrector Palette SPF 20 Sunscreen Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 212; 120 mg/g; mg/g N 20181231 68078-015_916e14f1-41f7-450c-89f6-a1e868088cba 68078-015 HUMAN OTC DRUG Brightening Perfector SPF 20 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 25; 39 mg/mL; mg/mL N 20181231 68078-016_56f1c37e-a200-48cc-9728-1043acb44089 68078-016 HUMAN OTC DRUG Bronzing Perfector SPF 20 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 50; 68 mg/mL; mg/mL N 20181231 68078-017_0e35a7b8-db8e-43eb-b243-622c560ffde7 68078-017 HUMAN OTC DRUG Calming Perfector SPF 20 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 54; 54 mg/mL; mg/mL N 20181231 68078-018_dd19f0d8-7ef6-4816-93b5-76959d020375 68078-018 HUMAN OTC DRUG Mattifying Perfector SPF 20 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 28; 53 mg/mL; mg/mL N 20181231 68078-019_13da0d64-1a31-4721-beaf-ed1980653ba2 68078-019 HUMAN OTC DRUG Daily UV Protector SPF 30 Sunscreen Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 54; 54 mg/mL; mg/mL N 20181231 68078-021_21b0c82f-1f18-4126-87d0-951d114200cc 68078-021 HUMAN OTC DRUG Sunforgettable Brush-On Sunscreen SPF 30 Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 210; 118 mg/g; mg/g N 20181231 68078-022_8a4cdef0-3e3c-4540-8e6b-67088c29e7ff 68078-022 HUMAN OTC DRUG Sunforgettable Brush-On Sunscreen SPF 50 Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 239; 241 mg/g; mg/g N 20181231 68078-023_18754273-ffd6-4147-833c-e03842bf2f79 68078-023 HUMAN OTC DRUG All Calm Clinical Redness Corrector SPF 50 Titanium Dioxide and Zinc Oxide LIQUID TOPICAL 20170802 OTC MONOGRAPH NOT FINAL part352 Colorescience TITANIUM DIOXIDE; ZINC OXIDE 116; 86 mg/mL; mg/mL N 20181231 68083-101_e47b17c4-e913-43cf-8406-c38e16f5ae36 68083-101 HUMAN PRESCRIPTION DRUG Adenosine Adenosine INJECTION INTRAVENOUS 20130401 ANDA ANDA077283 Gland Pharma Limited ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20181231 68083-103_b50a70ef-f6e8-482d-855d-ea87f0620f00 68083-103 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150724 ANDA ANDA076722 Gland Pharma Limited KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 68083-104_b50a70ef-f6e8-482d-855d-ea87f0620f00 68083-104 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150724 ANDA ANDA076722 Gland Pharma Limited KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 68083-106_1519c9b0-03e1-4e2f-9cb9-a4d693e92c69 68083-106 HUMAN PRESCRIPTION DRUG Midazolam hydrochloride Midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120601 ANDA ANDA090696 Gland Pharma Limited MIDAZOLAM HYDROCHLORIDE 1 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68083-108_6fbde135-5abb-47bf-918a-03f9461c3a5f 68083-108 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20120601 ANDA ANDA090850 Gland Pharma Limited MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68083-111_32cf74d8-23f2-40a0-b9a6-30df1cf17eb9 68083-111 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20120419 ANDA ANDA090699 Gland Pharma Limited LABETALOL HYDROCHLORIDE 5 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68083-112_5164f1b9-214d-4e85-9896-1693159b4782 68083-112 HUMAN PRESCRIPTION DRUG Amiodarone hydrochloride Amiodarone hydrochloride INJECTION, SOLUTION INTRAVENOUS 20130715 ANDA ANDA077161 Gland Pharma Limited AMIODARONE HYDROCHLORIDE 50 mg/mL Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 68083-113_d15e3bcf-450e-4b8c-a934-382b18d007a7 68083-113 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20090925 ANDA ANDA079224 Gland Pharma Limited ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68083-114_66a687dc-a84b-4e42-93a6-8cda51041829 68083-114 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20120615 ANDA ANDA090648 Gland Pharma Limited ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68083-116_06d57415-427f-4abe-8cbb-e14bf41037e5 68083-116 HUMAN PRESCRIPTION DRUG Zoledronic Acid zoledronic acid INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20130920 ANDA ANDA202930 Gland Pharma Limited ZOLEDRONIC ACID 4 mg/5mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 68083-117_fc986307-3023-4899-afa4-5e94f1c10aee 68083-117 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol INJECTION INTRAMUSCULAR 20160104 ANDA ANDA076774 Gland Pharma Limited HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20181231 68083-131_47e20cb8-c2be-42cb-aeef-13d403ecb693 68083-131 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate INJECTION INTRAVENOUS 20141006 ANDA ANDA204205 Gland Pharma Limited METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68083-132_bd470361-7562-4ade-b1bf-13f416eff1c1 68083-132 HUMAN PRESCRIPTION DRUG ketorolac tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161201 ANDA ANDA204216 Gland Pharma Limited KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 68083-133_bd470361-7562-4ade-b1bf-13f416eff1c1 68083-133 HUMAN PRESCRIPTION DRUG ketorolac tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161201 ANDA ANDA204216 Gland Pharma Limited KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 68083-134_bd470361-7562-4ade-b1bf-13f416eff1c1 68083-134 HUMAN PRESCRIPTION DRUG ketorolac tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR 20161201 ANDA ANDA204216 Gland Pharma Limited KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 68083-135_5d94ad70-bca5-4423-87fa-4ea7da69d0b2 68083-135 HUMAN PRESCRIPTION DRUG Zoledronic Acid Zoledronic Acid INJECTION, SOLUTION INTRAVENOUS 20160915 ANDA ANDA204217 Gland Pharma Limited ZOLEDRONIC ACID 5 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 68083-136_403bc1b5-f5b6-4c7f-8cf8-360289755ca9 68083-136 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION INTRAVENOUS; SUBCUTANEOUS 20170309 ANDA ANDA205323 Gland Pharma Limited HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 68083-137_4f1755c1-55da-4016-b943-da9913686822 68083-137 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20170518 ANDA ANDA205241 Gland Pharma Limited HALOPERIDOL DECANOATE 50 mg/mL Typical Antipsychotic [EPC] N 20181231 68083-138_4f1755c1-55da-4016-b943-da9913686822 68083-138 HUMAN PRESCRIPTION DRUG Haloperidol Decanoate Haloperidol Decanoate INJECTION INTRAMUSCULAR 20170518 ANDA ANDA205241 Gland Pharma Limited HALOPERIDOL DECANOATE 100 mg/mL Typical Antipsychotic [EPC] N 20181231 68083-139_4f896462-1289-4e89-af1d-cef76051f003 68083-139 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160630 ANDA ANDA205390 Gland Pharma Limited VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 68083-140_4f896462-1289-4e89-af1d-cef76051f003 68083-140 HUMAN PRESCRIPTION DRUG Vecuronium Bromide Vecuronium Bromide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160630 ANDA ANDA205390 Gland Pharma Limited VECURONIUM BROMIDE 1 mg/mL Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC] N 20181231 68083-141_69efc0d6-1280-4920-b920-c56bfc353602 68083-141 HUMAN PRESCRIPTION DRUG Argatroban Argatroban SOLUTION INTRAVENOUS 20170526 ANDA ANDA205570 Gland Pharma Limited ARGATROBAN 125 mg/125mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20181231 68083-143_4309e26c-0fd5-4c4a-ae42-6d4aa18a120f 68083-143 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160223 ANDA ANDA205694 Gland Pharma Limited VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 68083-144_4309e26c-0fd5-4c4a-ae42-6d4aa18a120f 68083-144 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride Vancomycin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160223 ANDA ANDA205694 Gland Pharma Limited VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 68083-146_ff7edac2-237c-4c0a-a596-6f2af559c921 68083-146 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION INTRAVENOUS 20170428 ANDA ANDA206141 Gland Pharma Limited MEROPENEM 500 mg/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 68083-147_ff7edac2-237c-4c0a-a596-6f2af559c921 68083-147 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION INTRAVENOUS 20170428 ANDA ANDA206141 Gland Pharma Limited MEROPENEM 1 g/30mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 68083-148_1eb501b1-e828-4d37-95bc-88a4cea3a606 68083-148 HUMAN PRESCRIPTION DRUG gemcitabine hydrochloride gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160201 ANDA ANDA204520 Gland Pharma Limited GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 68083-149_1eb501b1-e828-4d37-95bc-88a4cea3a606 68083-149 HUMAN PRESCRIPTION DRUG gemcitabine hydrochloride gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160201 ANDA ANDA204520 Gland Pharma Limited GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 68083-152_e8223019-5249-4243-91cb-aadcc163bec5 68083-152 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION INTRAVENOUS 20171107 ANDA ANDA206880 Gland Pharma Limited LEVETIRACETAM 5 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68083-153_e8223019-5249-4243-91cb-aadcc163bec5 68083-153 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION INTRAVENOUS 20171107 ANDA ANDA206880 Gland Pharma Limited LEVETIRACETAM 10 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68083-154_e8223019-5249-4243-91cb-aadcc163bec5 68083-154 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam INJECTION INTRAVENOUS 20171107 ANDA ANDA206880 Gland Pharma Limited LEVETIRACETAM 15 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68083-158_0697f39b-5865-479c-bc41-a1a4b9a89ed0 68083-158 HUMAN PRESCRIPTION DRUG Caspofungin Acetate Caspofungin Acetate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171029 ANDA ANDA207092 Gland Pharma Limited CASPOFUNGIN ACETATE 5 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 68083-159_0697f39b-5865-479c-bc41-a1a4b9a89ed0 68083-159 HUMAN PRESCRIPTION DRUG Caspofungin Acetate Caspofungin Acetate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171029 ANDA ANDA207092 Gland Pharma Limited CASPOFUNGIN ACETATE 7 mg/mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 68083-160_1b228f61-57fa-4fd5-b718-f6ffccfc3e30 68083-160 HUMAN PRESCRIPTION DRUG Tranexamic acid Tranexamic acid Tranexamic acid INJECTION, SOLUTION INTRAVENOUS 20170222 ANDA ANDA207239 Gland Pharma Limited TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 68083-161_3a25fa89-62e1-4bb5-aa1d-ced8aa8fe1a3 68083-161 HUMAN PRESCRIPTION DRUG Mesna Mesna Injection SOLUTION INTRAVENOUS 20171220 ANDA ANDA206992 Gland Pharma Limited MESNA 100 mg/mL Cytoprotective Agent [EPC] N 20181231 68083-162_5a24d5bd-c44a-43f7-a04c-76caf3475012 68083-162 HUMAN PRESCRIPTION DRUG CISPLATIN Cisplatin INJECTION, SOLUTION INTRAVENOUS 20170403 ANDA ANDA207323 Gland Pharma Limited CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 68083-163_5a24d5bd-c44a-43f7-a04c-76caf3475012 68083-163 HUMAN PRESCRIPTION DRUG CISPLATIN Cisplatin INJECTION, SOLUTION INTRAVENOUS 20170403 ANDA ANDA207323 Gland Pharma Limited CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 68083-170_0d039035-85d1-40d4-8ee6-540026ab7a5c 68083-170 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170529 ANDA ANDA207385 Gland Pharma Limited OXALIPLATIN 50 mg/10mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 68083-171_0d039035-85d1-40d4-8ee6-540026ab7a5c 68083-171 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170529 ANDA ANDA207385 Gland Pharma Limited OXALIPLATIN 100 mg/20mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 68083-172_2d0db797-db19-4c14-ba7e-0fcfff1affe5 68083-172 HUMAN PRESCRIPTION DRUG Deferoxamine mesylate Deferoxamine mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20171009 ANDA ANDA207384 Gland Pharma Limited DEFEROXAMINE MESYLATE 500 mg/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] N 20181231 68083-173_2d0db797-db19-4c14-ba7e-0fcfff1affe5 68083-173 HUMAN PRESCRIPTION DRUG Deferoxamine mesylate Deferoxamine mesylate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171009 ANDA ANDA207384 Gland Pharma Limited DEFEROXAMINE MESYLATE 2 g/1 Iron Chelating Activity [MoA],Iron Chelator [EPC] N 20181231 68083-174_d5c9defd-8390-427d-b59c-00f202153b10 68083-174 HUMAN PRESCRIPTION DRUG POLYMYXIN B POLYMYXIN B SULFATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20160601 ANDA ANDA207322 Gland Pharma Limited POLYMYXIN B SULFATE 500000 1/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 68083-176_3bbae24b-1d25-4516-b080-1f264c7dea18 68083-176 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20171106 ANDA ANDA207325 Gland Pharma Limited OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 68083-177_3bbae24b-1d25-4516-b080-1f264c7dea18 68083-177 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20171106 ANDA ANDA207325 Gland Pharma Limited OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 68083-178_aeff20f1-c4e7-46c6-a6cb-f0aab334571b 68083-178 HUMAN PRESCRIPTION DRUG PACLITAXEL PACLITAXEL paclitaxel INJECTION, SOLUTION INTRAVENOUS 20160930 ANDA ANDA207326 Gland Pharma Limited PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 68083-179_aeff20f1-c4e7-46c6-a6cb-f0aab334571b 68083-179 HUMAN PRESCRIPTION DRUG PACLITAXEL PACLITAXEL paclitaxel INJECTION, SOLUTION INTRAVENOUS 20160930 ANDA ANDA207326 Gland Pharma Limited PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 68083-180_aeff20f1-c4e7-46c6-a6cb-f0aab334571b 68083-180 HUMAN PRESCRIPTION DRUG PACLITAXEL PACLITAXEL paclitaxel INJECTION, SOLUTION INTRAVENOUS 20160930 ANDA ANDA207326 Gland Pharma Limited PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 68083-190_f171db85-7a96-42ae-a443-f31586f94803 68083-190 HUMAN PRESCRIPTION DRUG CARBOPLATIN Carboplatin INJECTION, SOLUTION INTRAVENOUS 20170220 ANDA ANDA207324 Gland Pharma Limited CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 68083-191_f171db85-7a96-42ae-a443-f31586f94803 68083-191 HUMAN PRESCRIPTION DRUG CARBOPLATIN Carboplatin INJECTION, SOLUTION INTRAVENOUS 20170220 ANDA ANDA207324 Gland Pharma Limited CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 68083-192_f171db85-7a96-42ae-a443-f31586f94803 68083-192 HUMAN PRESCRIPTION DRUG CARBOPLATIN Carboplatin INJECTION, SOLUTION INTRAVENOUS 20170220 ANDA ANDA207324 Gland Pharma Limited CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 68083-193_f171db85-7a96-42ae-a443-f31586f94803 68083-193 HUMAN PRESCRIPTION DRUG CARBOPLATIN Carboplatin INJECTION, SOLUTION INTRAVENOUS 20170220 ANDA ANDA207324 Gland Pharma Limited CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 68083-195_9a0e54ca-a444-4474-94fc-0b4ac5b0e394 68083-195 HUMAN PRESCRIPTION DRUG Dexrazoxane Dexrazoxane for Injection INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20161205 ANDA ANDA207321 Gland Pharma Limited DEXRAZOXANE HYDROCHLORIDE 500 mg/50mL Cytoprotective Agent [EPC] N 20181231 68083-199_2427342f-14b2-4e21-a07e-58edde96e7a8 68083-199 HUMAN PRESCRIPTION DRUG Azithromycin monohydrate Azithromycin monohydrate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20091109 ANDA ANDA065501 Gland Pharma Limited AZITHROMYCIN MONOHYDRATE 500 mg/10mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68083-234_3e4fa967-6ab9-4de0-af94-f9c479504b20 68083-234 HUMAN PRESCRIPTION DRUG Etomidate Etomidate Injection SOLUTION INTRAVENOUS 20170520 ANDA ANDA209058 Gland Pharma Limited ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 68083-235_3e4fa967-6ab9-4de0-af94-f9c479504b20 68083-235 HUMAN PRESCRIPTION DRUG Etomidate Etomidate Injection SOLUTION INTRAVENOUS 20170520 ANDA ANDA209058 Gland Pharma Limited ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 68083-248_1adc3970-f5f1-421b-ae96-59239f899aba 68083-248 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20170822 ANDA ANDA209825 Gland Pharma Limited DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 68083-249_1adc3970-f5f1-421b-ae96-59239f899aba 68083-249 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20170822 ANDA ANDA209825 Gland Pharma Limited DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 68083-250_1adc3970-f5f1-421b-ae96-59239f899aba 68083-250 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, SOLUTION INTRAVENOUS 20170822 ANDA ANDA209825 Gland Pharma Limited DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 68083-269_a4318dc9-9c60-4e5d-9426-e231aec7715a 68083-269 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20171107 ANDA ANDA210123 Gland Pharma Limited FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 68083-270_a4318dc9-9c60-4e5d-9426-e231aec7715a 68083-270 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20171107 ANDA ANDA210123 Gland Pharma Limited FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 68083-292_55f66165-9ec7-434f-9c41-34ec75fda2a7 68083-292 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20180105 ANDA ANDA210124 Gland Pharma Limited FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 68083-293_55f66165-9ec7-434f-9c41-34ec75fda2a7 68083-293 HUMAN PRESCRIPTION DRUG Fluorouracil Fluorouracil INJECTION, SOLUTION INTRAVENOUS 20180105 ANDA ANDA210124 Gland Pharma Limited FLUOROURACIL 50 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 68083-314_3bbae24b-1d25-4516-b080-1f264c7dea18 68083-314 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20171106 ANDA ANDA207325 Gland Pharma Limited OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 68083-318_43fd392a-531d-4d69-917e-f19b16272d7b 68083-318 HUMAN PRESCRIPTION DRUG Milrinone Lactate Milrinone Lactate INJECTION INTRAVENOUS 20170728 ANDA ANDA077190 Gland Pharma Limited MILRINONE LACTATE 1 mg/mL Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 68084-021_5cdbcf4a-4b9b-5549-e053-2991aa0a6550 68084-021 HUMAN PRESCRIPTION DRUG Abacavir Abacavir Sulfate TABLET, FILM COATED ORAL 20130124 ANDA ANDA077844 American Health Packaging ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68084-022_5e331ad2-675d-5e76-e053-2a91aa0a823c 68084-022 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 20130605 ANDA ANDA072579 American Health Packaging NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68084-027_5d922efa-b0ea-053a-e053-2a91aa0abb98 68084-027 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20040729 ANDA ANDA040301 American Health Packaging WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 68084-040_63b4595a-2c41-1db8-e053-2991aa0a0d6e 68084-040 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20130708 ANDA ANDA091667 American Health Packaging MISOPROSTOL 100 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20191231 68084-041_63b4595a-2c41-1db8-e053-2991aa0a0d6e 68084-041 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20130708 ANDA ANDA091667 American Health Packaging MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20191231 68084-044_57d528b9-0b13-36c9-e053-2991aa0a5f86 68084-044 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20080101 ANDA ANDA077584 American Health Packaging PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-045_57d528b9-0b13-36c9-e053-2991aa0a5f86 68084-045 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20080315 ANDA ANDA077584 American Health Packaging PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-046_57d528b9-0b13-36c9-e053-2991aa0a5f86 68084-046 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20080101 ANDA ANDA077584 American Health Packaging PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-047_57d528b9-0b13-36c9-e053-2991aa0a5f86 68084-047 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20080615 ANDA ANDA077584 American Health Packaging PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-048_5c73b903-8819-b68e-e053-2a91aa0aaa35 68084-048 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20130722 ANDA ANDA077290 American Health Packaging OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-051_2e19914e-0be5-5fbf-e054-00144ff8d46c 68084-051 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20131028 ANDA ANDA075280 American Health Packaging NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68084-052_591866e1-5759-28fd-e053-2991aa0a8b40 68084-052 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20130415 20180930 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68084-053_591866e1-5759-28fd-e053-2991aa0a8b40 68084-053 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20130310 20180831 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68084-053_5cdcf5a0-6e5a-5c05-e053-2a91aa0a7eca 68084-053 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20130419 20180930 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68084-054_591866e1-5759-28fd-e053-2991aa0a8b40 68084-054 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20130315 20180930 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68084-054_5cdcf5a0-6e5a-5c05-e053-2a91aa0a7eca 68084-054 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20130530 20180930 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68084-055_591866e1-5759-28fd-e053-2991aa0a8b40 68084-055 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20130401 20180731 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68084-055_5cdcf5a0-6e5a-5c05-e053-2a91aa0a7eca 68084-055 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20130326 20180731 ANDA ANDA074984 American Health Packaging DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68084-056_5abee24d-26a6-c453-e053-2991aa0afd80 68084-056 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130611 ANDA ANDA090200 American Health Packaging METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68084-057_5abee24d-26a6-c453-e053-2991aa0afd80 68084-057 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130611 ANDA ANDA090200 American Health Packaging METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68084-059_57e7482a-6ef3-11af-e053-2991aa0ab06f 68084-059 HUMAN PRESCRIPTION DRUG Zafirlukast Zafirlukast TABLET, FILM COATED ORAL 20130603 ANDA ANDA090372 American Health Packaging ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 68084-069_5a083c9a-9c6e-cc67-e053-2991aa0a56ef 68084-069 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20040818 ANDA ANDA076794 American Health Packaging CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68084-070_5a083c9a-9c6e-cc67-e053-2991aa0a56ef 68084-070 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20040818 ANDA ANDA076794 American Health Packaging CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68084-071_5a083c9a-9c6e-cc67-e053-2991aa0a56ef 68084-071 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20040818 ANDA ANDA076794 American Health Packaging CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68084-072_643fec1a-9e2b-4530-e053-2a91aa0a0128 68084-072 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20100319 ANDA ANDA078596 American Health Packaging METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 68084-075_b22d5a07-623a-4645-b87d-a151b86da8d5 68084-075 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CAPSULE ORAL 20130718 ANDA ANDA201687 American Health Packaging TRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] E 20171231 68084-077_2eba4ae6-75d9-168f-e054-00144ff88e88 68084-077 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20140217 NDA NDA016620 American Health Packaging NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 68084-078_2eba4ae6-75d9-168f-e054-00144ff88e88 68084-078 HUMAN PRESCRIPTION DRUG Nitrofurantoin Macrocrystals Nitrofurantoin Macrocrystals CAPSULE ORAL 20140217 NDA NDA016620 American Health Packaging NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 68084-082_5fc387c6-c4c8-4384-e053-2a91aa0ac590 68084-082 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20131015 ANDA ANDA086925 American Health Packaging ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68084-083_5fc387c6-c4c8-4384-e053-2a91aa0ac590 68084-083 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20131015 ANDA ANDA087537 American Health Packaging ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68084-093_5ae2ee9f-b4f4-e2bd-e053-2991aa0ab0e3 68084-093 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20050713 ANDA ANDA074260 American Health Packaging CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 68084-094_5ae2ee9f-b4f4-e2bd-e053-2991aa0ab0e3 68084-094 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20060831 ANDA ANDA074260 American Health Packaging CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 68084-097_587752ba-fcbf-3171-e053-2991aa0a0878 68084-097 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130715 ANDA ANDA090548 American Health Packaging ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68084-098_587752ba-fcbf-3171-e053-2991aa0a0878 68084-098 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130601 ANDA ANDA090548 American Health Packaging ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68084-099_587752ba-fcbf-3171-e053-2991aa0a0878 68084-099 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130815 ANDA ANDA090548 American Health Packaging ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68084-101_5c51b471-253a-46fc-e053-2a91aa0a25f4 68084-101 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20131205 ANDA ANDA078619 American Health Packaging FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-103_57d528b9-0bcb-36c9-e053-2991aa0a5f86 68084-103 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone HCl CAPSULE ORAL 20141115 ANDA ANDA077561 American Health Packaging ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-104_57d528b9-0bcb-36c9-e053-2991aa0a5f86 68084-104 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone HCl CAPSULE ORAL 20141115 ANDA ANDA077561 American Health Packaging ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-105_57d528b9-0bcb-36c9-e053-2991aa0a5f86 68084-105 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone HCl CAPSULE ORAL 20141115 ANDA ANDA077561 American Health Packaging ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-106_57d528b9-0bcb-36c9-e053-2991aa0a5f86 68084-106 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone HCl CAPSULE ORAL 20141115 ANDA ANDA077561 American Health Packaging ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-107_4d125219-8595-2d0b-e054-00144ff88e88 68084-107 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20140129 ANDA ANDA075677 American Health Packaging ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68084-108_5fc68f04-ec68-11c0-e053-2a91aa0a1952 68084-108 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20140129 ANDA ANDA077309 American Health Packaging ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68084-109_5fc68f04-ec68-11c0-e053-2a91aa0a1952 68084-109 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20140129 ANDA ANDA077309 American Health Packaging ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68084-111_70eceda4-01fb-4c28-9241-06dff4996b43 68084-111 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080609 ANDA ANDA076467 American Health Packaging GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68084-112_70eceda4-01fb-4c28-9241-06dff4996b43 68084-112 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080609 ANDA ANDA076467 American Health Packaging GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68084-119_5812bb0f-dd86-a9b1-e053-2991aa0a6cee 68084-119 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20051015 ANDA ANDA076921 American Health Packaging MIRTAZAPINE 15 mg/1 N 20181231 68084-120_5812bb0f-dd86-a9b1-e053-2991aa0a6cee 68084-120 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20051015 ANDA ANDA076921 American Health Packaging MIRTAZAPINE 30 mg/1 N 20181231 68084-121_5812bb0f-dd86-a9b1-e053-2991aa0a6cee 68084-121 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20051015 ANDA ANDA076921 American Health Packaging MIRTAZAPINE 45 mg/1 N 20181231 68084-128_593f997d-f419-24ec-e053-2991aa0a4716 68084-128 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20091023 ANDA ANDA075576 American Health Packaging OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68084-135_47148991-7515-4309-e054-00144ff8d46c 68084-135 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20131209 ANDA ANDA203399 American Health Packaging METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 68084-149_5f8b8917-93a7-ef18-e053-2a91aa0a33d8 68084-149 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 20131125 ANDA ANDA040183 American Health Packaging METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68084-154_5d135044-6073-180a-e053-2991aa0ab763 68084-154 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20070110 ANDA ANDA040596 American Health Packaging PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68084-155_5d135044-6073-180a-e053-2991aa0ab763 68084-155 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060830 ANDA ANDA040596 American Health Packaging PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68084-174_f2b76bf1-de07-4d23-bcce-20387aeab219 68084-174 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20100907 ANDA ANDA078292 American Health Packaging DRONABINOL 2.5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 68084-175_f2b76bf1-de07-4d23-bcce-20387aeab219 68084-175 HUMAN PRESCRIPTION DRUG Dronabinol Dronabinol CAPSULE ORAL 20100923 ANDA ANDA078292 American Health Packaging DRONABINOL 5 mg/1 Cannabinoid [EPC],Cannabinoids [Chemical/Ingredient] CIII N 20181231 68084-179_5df53c82-6ca1-3edc-e053-2991aa0adc05 68084-179 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20061130 ANDA ANDA077224 American Health Packaging RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 68084-180_559d7aba-7a93-6e08-e054-00144ff88e88 68084-180 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20101201 20190228 ANDA ANDA077397 American Health Packaging SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-181_559d7aba-7a93-6e08-e054-00144ff88e88 68084-181 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20101201 20190430 ANDA ANDA077397 American Health Packaging SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-182_559d7aba-7a93-6e08-e054-00144ff88e88 68084-182 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20101201 20190131 ANDA ANDA077397 American Health Packaging SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-184_62d7ea73-6ad8-cb27-e053-2a91aa0ac0d4 68084-184 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20061109 ANDA ANDA076636 American Health Packaging OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 68084-185_62d7ea73-6ad8-cb27-e053-2a91aa0ac0d4 68084-185 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20061108 ANDA ANDA076636 American Health Packaging OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 68084-189_5f9e5139-ac45-593f-e053-2a91aa0a66ec 68084-189 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20140107 ANDA ANDA077322 American Health Packaging ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 68084-196_5e99029f-7e36-781e-e053-2991aa0a49c4 68084-196 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140210 ANDA ANDA077321 American Health Packaging LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-197_5e99029f-7e36-781e-e053-2991aa0a49c4 68084-197 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131223 20190430 ANDA ANDA077321 American Health Packaging LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-198_5e99029f-7e36-781e-e053-2991aa0a49c4 68084-198 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131223 20190430 ANDA ANDA077321 American Health Packaging LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-199_5e99029f-7e36-781e-e053-2991aa0a49c4 68084-199 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131223 ANDA ANDA077321 American Health Packaging LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-200_5f9e5139-ac45-593f-e053-2a91aa0a66ec 68084-200 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, COATED ORAL 20140107 ANDA ANDA077322 American Health Packaging ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 68084-202_5b206c16-a93e-62fa-e053-2a91aa0a4c7b 68084-202 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20070614 ANDA ANDA084903 American Health Packaging PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-203_5b206c16-a93e-62fa-e053-2a91aa0a4c7b 68084-203 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20070614 ANDA ANDA084903 American Health Packaging PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-204_5df4a292-7afa-5416-e053-2991aa0a06ce 68084-204 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20070705 ANDA ANDA071826 American Health Packaging MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68084-205_5df4a292-7afa-5416-e053-2991aa0a06ce 68084-205 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20070705 ANDA ANDA071839 American Health Packaging MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68084-206_5d059977-3757-931b-e053-2a91aa0a0943 68084-206 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20100305 ANDA ANDA040750 American Health Packaging SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68084-207_5d059977-3757-931b-e053-2a91aa0a0943 68084-207 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20100215 ANDA ANDA040750 American Health Packaging SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68084-208_5d059977-3757-931b-e053-2a91aa0a0943 68084-208 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20100215 ANDA ANDA040750 American Health Packaging SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68084-215_36f8b446-48a9-22d3-e054-00144ff88e88 68084-215 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20140228 ANDA ANDA090682 American Health Packaging VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68084-216_3816c009-2964-57c6-e054-00144ff88e88 68084-216 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20140124 ANDA ANDA070035 American Health Packaging METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68084-217_598b156e-6eb7-46db-e053-2991aa0aa167 68084-217 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20141215 ANDA ANDA202910 American Health Packaging IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68084-220_5b454a11-e136-786e-e053-2991aa0a9bd6 68084-220 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20120716 ANDA ANDA078539 American Health Packaging ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68084-221_5b454a11-e136-786e-e053-2991aa0a9bd6 68084-221 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20120702 ANDA ANDA078539 American Health Packaging ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68084-229_23ba97f7-5ebd-1d4b-e054-00144ff8d46c 68084-229 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20080222 ANDA ANDA077621 American Health Packaging AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 68084-230_4714dec5-ba87-4aa0-e054-00144ff8d46c 68084-230 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20130626 ANDA ANDA076899 American Health Packaging SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68084-240_5ae1bc9f-eb46-97be-e053-2991aa0a3879 68084-240 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20100511 ANDA ANDA076514 American Health Packaging MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 68084-241_5ae1bc9f-eb46-97be-e053-2991aa0a3879 68084-241 HUMAN PRESCRIPTION DRUG Midodrine HCl Midodrine Hydrochloride TABLET ORAL 20100511 ANDA ANDA076514 American Health Packaging MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 68084-243_5070440e-40e5-44f3-e054-00144ff88e88 68084-243 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20080422 ANDA ANDA065061 American Health Packaging CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68084-244_5070440e-40e5-44f3-e054-00144ff88e88 68084-244 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20080422 ANDA ANDA065061 American Health Packaging CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68084-248_2e1973c5-97f3-17e3-e054-00144ff88e88 68084-248 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20080108 ANDA ANDA076134 American Health Packaging LORATADINE 10 mg/1 N 20181231 68084-249_5f870db7-3855-44fd-e053-2a91aa0af219 68084-249 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080311 ANDA ANDA077580 American Health Packaging HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] N 20181231 68084-250_5f870db7-3855-44fd-e053-2a91aa0af219 68084-250 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080402 ANDA ANDA077580 American Health Packaging HALOPERIDOL 20 mg/1 Typical Antipsychotic [EPC] N 20181231 68084-252_5fc5870f-9454-61d6-e053-2a91aa0a1202 68084-252 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20080605 ANDA ANDA077284 American Health Packaging BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68084-253_55d97d0a-5f61-196c-e054-00144ff88e88 68084-253 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20090113 ANDA ANDA040786 American Health Packaging HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68084-254_55d97d0a-5f61-196c-e054-00144ff88e88 68084-254 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20090113 ANDA ANDA040787 American Health Packaging HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68084-255_55d97d0a-5f61-196c-e054-00144ff88e88 68084-255 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20090113 ANDA ANDA040788 American Health Packaging HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68084-259_559f1dfb-0a56-3827-e054-00144ff88e88 68084-259 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140115 20180430 ANDA ANDA077955 American Health Packaging AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68084-266_5de3dc10-d0a4-a269-e053-2a91aa0a3df8 68084-266 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080122 20180831 ANDA ANDA076549 American Health Packaging RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-267_5de3dc10-d0a4-a269-e053-2a91aa0a3df8 68084-267 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080122 20180731 ANDA ANDA076549 American Health Packaging RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-268_5de3dc10-d0a4-a269-e053-2a91aa0a3df8 68084-268 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080122 20180831 ANDA ANDA076549 American Health Packaging RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-269_5fc3a067-e406-63f1-e053-2a91aa0ae62c 68084-269 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET, FILM COATED ORAL 20080805 ANDA ANDA040657 American Health Packaging HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 68084-270_5fc169dc-63e8-52ae-e053-2991aa0a7caa 68084-270 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 American Health Packaging RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-271_5fc169dc-63e8-52ae-e053-2991aa0a7caa 68084-271 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 American Health Packaging RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-272_5fc169dc-63e8-52ae-e053-2991aa0a7caa 68084-272 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 American Health Packaging RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-273_5fc169dc-63e8-52ae-e053-2991aa0a7caa 68084-273 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 American Health Packaging RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-274_5fc169dc-63e8-52ae-e053-2991aa0a7caa 68084-274 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 American Health Packaging RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-275_5ad3108f-acf4-0bbc-e053-2991aa0acc59 68084-275 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20100309 ANDA ANDA040411 American Health Packaging METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 68084-276_5ad3108f-acf4-0bbc-e053-2991aa0acc59 68084-276 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20100310 ANDA ANDA040411 American Health Packaging METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 68084-277_5fc169dc-63e8-52ae-e053-2991aa0a7caa 68084-277 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET, FILM COATED ORAL 20081202 ANDA ANDA078040 American Health Packaging RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-278_491fde92-1f67-31ea-e054-00144ff8d46c 68084-278 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20130719 20180228 ANDA ANDA065404 American Health Packaging AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68084-280_5c4ff036-7122-373a-e053-2a91aa0a756a 68084-280 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET ORAL 20091102 ANDA ANDA078939 American Health Packaging ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] N 20181231 68084-281_5823c303-5c7b-3a05-e053-2a91aa0a72d1 68084-281 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20080828 ANDA ANDA077828 American Health Packaging CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 68084-282_5823c303-5c7b-3a05-e053-2a91aa0a72d1 68084-282 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET, EXTENDED RELEASE ORAL 20080828 ANDA ANDA077828 American Health Packaging CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 68084-284_5c73493d-6353-3720-e053-2a91aa0a098b 68084-284 HUMAN PRESCRIPTION DRUG Hydroxyurea Hydroxyurea CAPSULE ORAL 20080813 ANDA ANDA075340 American Health Packaging HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] N 20181231 68084-288_5c64bf7e-6688-1bb3-e053-2991aa0a63db 68084-288 HUMAN PRESCRIPTION DRUG Fludrocortisone Acetate Fludrocortisone Acetate TABLET ORAL 20080909 ANDA ANDA040431 American Health Packaging FLUDROCORTISONE ACETATE .1 mg/1 N 20181231 68084-291_5939ef66-5499-b24a-e053-2a91aa0a0ec1 68084-291 HUMAN PRESCRIPTION DRUG NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET, FILM COATED ORAL 20121210 ANDA ANDA076264 American Health Packaging NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 68084-294_5de3dc10-d0a4-a269-e053-2a91aa0a3df8 68084-294 HUMAN PRESCRIPTION DRUG Ramipril ramipril CAPSULE ORAL 20080609 20180731 ANDA ANDA076549 American Health Packaging RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-295_70eceda4-01fb-4c28-9241-06dff4996b43 68084-295 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081030 ANDA ANDA076467 American Health Packaging GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68084-299_57d50977-bb89-0b92-e053-2991aa0abc48 68084-299 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20131201 ANDA ANDA078225 American Health Packaging TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68084-300_5cea8626-7ee7-8a13-e053-2991aa0a77bb 68084-300 HUMAN PRESCRIPTION DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL 20080929 ANDA ANDA076856 American Health Packaging DANTROLENE SODIUM 25 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 68084-309_36f8b446-48a9-22d3-e054-00144ff88e88 68084-309 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET, FILM COATED ORAL 20140228 ANDA ANDA090682 American Health Packaging VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68084-310_5b489d1b-07fc-71f1-e053-2991aa0ab3f9 68084-310 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131115 ANDA ANDA078239 American Health Packaging DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68084-313_597cf3f8-69d8-1596-e053-2a91aa0ab58b 68084-313 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium CAPSULE, COATED PELLETS ORAL 20090326 ANDA ANDA078919 American Health Packaging DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68084-318_5de17d65-565c-c740-e053-2a91aa0aff87 68084-318 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090707 ANDA ANDA077633 American Health Packaging LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68084-319_5de17d65-565c-c740-e053-2a91aa0aff87 68084-319 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090706 ANDA ANDA077633 American Health Packaging LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68084-326_57fc77dc-c76d-ef19-e053-2a91aa0adfde 68084-326 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20090501 ANDA ANDA077091 American Health Packaging GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68084-327_57fc77dc-c76d-ef19-e053-2a91aa0adfde 68084-327 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20090504 ANDA ANDA077091 American Health Packaging GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68084-328_5b1f8da0-bc82-a031-e053-2991aa0a60e8 68084-328 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20090115 ANDA ANDA076509 American Health Packaging FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68084-329_58fea1ef-d55d-fbc3-e053-2991aa0a4871 68084-329 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20090123 ANDA ANDA075868 American Health Packaging FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68084-333_597e2b7e-50a5-1d2b-e053-2991aa0a7f47 68084-333 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20090330 ANDA ANDA077863 American Health Packaging DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68084-335_5cd6a3e9-92e6-bf1b-e053-2991aa0a1fce 68084-335 HUMAN PRESCRIPTION DRUG Lamotrigine lamotrigine TABLET, CHEWABLE ORAL 20090310 20180831 ANDA ANDA076928 American Health Packaging LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68084-342_556357be-b6f4-2cd5-e054-00144ff8d46c 68084-342 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20100615 ANDA ANDA078235 American Health Packaging TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68084-344_556357be-b6f4-2cd5-e054-00144ff8d46c 68084-344 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20100715 ANDA ANDA078235 American Health Packaging TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68084-345_556357be-b6f4-2cd5-e054-00144ff8d46c 68084-345 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20100215 ANDA ANDA078235 American Health Packaging TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68084-346_59a5c201-b0ff-1fe0-e053-2a91aa0a8609 68084-346 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101012 ANDA ANDA078243 American Health Packaging LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68084-347_59a5c201-b0ff-1fe0-e053-2a91aa0a8609 68084-347 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101012 ANDA ANDA078243 American Health Packaging LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68084-348_59a5c201-b0ff-1fe0-e053-2a91aa0a8609 68084-348 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101013 ANDA ANDA078243 American Health Packaging LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68084-354_2f2a8576-2530-486f-9def-b34e0121f8f6 68084-354 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20091209 ANDA ANDA091393 American Health Packaging OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-355_5fc290e6-930f-8a69-e053-2a91aa0ae69c 68084-355 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20090923 ANDA ANDA040777 American Health Packaging OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-357_5e2fac91-ed0b-069e-e053-2a91aa0a8546 68084-357 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20091027 ANDA ANDA065390 American Health Packaging RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 68084-358_5e2fac91-ed0b-069e-e053-2a91aa0a8546 68084-358 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20091027 ANDA ANDA065390 American Health Packaging RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 68084-360_5ae038ca-6a2d-dc30-e053-2a91aa0a0a41 68084-360 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20091201 ANDA ANDA076368 American Health Packaging POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68084-361_5d179ebe-ea56-8ed5-e053-2991aa0ad7f7 68084-361 HUMAN PRESCRIPTION DRUG Propafenone HCl Propafenone hydrochloride TABLET, FILM COATED ORAL 20090708 ANDA ANDA075203 American Health Packaging PROPAFENONE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] N 20181231 68084-365_604f4dfb-faac-3940-e053-2991aa0aef80 68084-365 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20150204 ANDA ANDA040855 American Health Packaging BETHANECHOL CHLORIDE 10 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20191231 68084-366_62d85069-36ee-8ffc-e053-2a91aa0a8085 68084-366 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20140923 ANDA ANDA078556 American Health Packaging DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20191231 68084-371_597a6144-31c5-9533-e053-2991aa0ab896 68084-371 HUMAN PRESCRIPTION DRUG AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE TABLET ORAL 20090915 ANDA ANDA079029 American Health Packaging AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 68084-372_5bb03749-6d0e-c96d-e053-2a91aa0affe9 68084-372 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine Phosphate acetaminophen and codeine phosphate TABLET ORAL 20100113 ANDA ANDA089805 American Health Packaging ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 68084-373_5bb03749-6d0e-c96d-e053-2a91aa0affe9 68084-373 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine Phosphate acetaminophen and codeine phosphate TABLET ORAL 20100113 ANDA ANDA089828 American Health Packaging ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 68084-376_5bd6f707-fead-0d21-e053-2991aa0a7915 68084-376 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20100517 ANDA ANDA040765 American Health Packaging PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 68084-380_5810c0fb-d3ab-8ee2-e053-2a91aa0a9bb3 68084-380 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20091221 ANDA ANDA040245 American Health Packaging CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 68084-381_58999a17-5346-e2fc-e053-2991aa0ab45b 68084-381 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20091101 ANDA ANDA040715 American Health Packaging BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 68084-388_58999a17-5346-e2fc-e053-2991aa0ab45b 68084-388 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20091215 ANDA ANDA040715 American Health Packaging BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 68084-389_58999a17-5346-e2fc-e053-2991aa0ab45b 68084-389 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20091215 ANDA ANDA040715 American Health Packaging BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 68084-390_5baea1b4-58f3-4607-e053-2991aa0ab2f3 68084-390 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090522 ANDA ANDA075483 American Health Packaging ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68084-391_5baea1b4-58f3-4607-e053-2991aa0ab2f3 68084-391 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090526 ANDA ANDA075483 American Health Packaging ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68084-392_5baea1b4-58f3-4607-e053-2991aa0ab2f3 68084-392 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20090526 ANDA ANDA075483 American Health Packaging ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68084-396_58b1676d-1276-5c90-e053-2991aa0afb15 68084-396 HUMAN PRESCRIPTION DRUG BUTALBITAL, ACETAMINOPHEN AND CAFFEINE BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET ORAL 20090901 ANDA ANDA040511 American Health Packaging BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68084-399_2025d19e-d717-4bd5-8805-35698cbdc7c2 68084-399 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20120217 ANDA ANDA077914 American Health Packaging FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68084-400_2eb93d7c-3318-4b93-e054-00144ff88e88 68084-400 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 20100113 ANDA ANDA075079 American Health Packaging OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68084-401_5c4fafb3-5b49-cdbd-e053-2a91aa0a6eb4 68084-401 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20100301 ANDA ANDA040904 American Health Packaging ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 68084-403_abc25a29-f95f-415b-a5d2-4bac1d846c02 68084-403 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 20110801 ANDA ANDA075295 American Health Packaging MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-404_abc25a29-f95f-415b-a5d2-4bac1d846c02 68084-404 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 20110801 ANDA ANDA075295 American Health Packaging MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-405_abc25a29-f95f-415b-a5d2-4bac1d846c02 68084-405 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 20110801 ANDA ANDA075295 American Health Packaging MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-406_abc25a29-f95f-415b-a5d2-4bac1d846c02 68084-406 HUMAN PRESCRIPTION DRUG morphine sulfate morphine sulfate TABLET, EXTENDED RELEASE ORAL 20110801 ANDA ANDA075295 American Health Packaging MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-411_4417ad6b-c238-6569-e054-00144ff88e88 68084-411 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20100326 ANDA ANDA079175 American Health Packaging INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68084-415_5b489d1b-07fc-71f1-e053-2991aa0ab3f9 68084-415 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20131114 ANDA ANDA078239 American Health Packaging DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68084-416_592d1262-1bed-2fa2-e053-2991aa0a27fc 68084-416 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20140215 ANDA ANDA202418 American Health Packaging LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68084-419_229e82e0-9315-1411-e054-00144ff88e88 68084-419 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20120702 NDA AUTHORIZED GENERIC NDA018238 American Health Packaging POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68084-423_5f8b87f5-2957-6220-e053-2991aa0a3a21 68084-423 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20110328 ANDA ANDA078439 American Health Packaging HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-424_63a05100-afaa-d693-e053-2991aa0a80a2 68084-424 HUMAN PRESCRIPTION DRUG Oxandrolone oxandrolone TABLET ORAL 20121114 ANDA ANDA077827 American Health Packaging OXANDROLONE 2.5 mg/1 CIII N 20191231 68084-425_63a05100-afaa-d693-e053-2991aa0a80a2 68084-425 HUMAN PRESCRIPTION DRUG Oxandrolone oxandrolone TABLET ORAL 20151209 ANDA ANDA077827 American Health Packaging OXANDROLONE 10 mg/1 CIII N 20191231 68084-430_4d11f415-6b22-277b-e054-00144ff8d46c 68084-430 HUMAN OTC DRUG healthylax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20100901 ANDA ANDA090812 American Health Packaging POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 68084-440_5f4a16fd-0114-0665-e053-2a91aa0ac4a1 68084-440 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20110518 ANDA ANDA078920 American Health Packaging PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68084-444_5420182b-bc3a-5828-e054-00144ff8d46c 68084-444 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20140401 ANDA ANDA075948 American Health Packaging CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 68084-446_5c72dd08-d00b-57d8-e053-2991aa0ad512 68084-446 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin (monohydrate/macrocrystals) CAPSULE ORAL 20101004 ANDA ANDA077066 American Health Packaging NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 68084-447_58af1a75-4acf-0506-e053-2991aa0a738f 68084-447 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20100910 ANDA ANDA086242 American Health Packaging HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68084-449_5d7e9c9e-c100-05b1-e053-2991aa0a2741 68084-449 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100802 ANDA ANDA090509 American Health Packaging TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 68084-450_5d7e9c9e-c100-05b1-e053-2991aa0a2741 68084-450 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100802 ANDA ANDA090509 American Health Packaging TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 68084-451_5d7e9c9e-c100-05b1-e053-2991aa0a2741 68084-451 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE ORAL 20100803 ANDA ANDA090509 American Health Packaging TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 68084-458_5b23a329-9e2d-a783-e053-2a91aa0aaa84 68084-458 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20110118 ANDA ANDA077463 American Health Packaging NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 68084-459_5b23a329-9e2d-a783-e053-2a91aa0aaa84 68084-459 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20110118 ANDA ANDA077463 American Health Packaging NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 68084-461_559d986c-07db-6f77-e054-00144ff8d46c 68084-461 HUMAN PRESCRIPTION DRUG Zidovudine zidovudine CAPSULE ORAL 20110201 20181031 ANDA ANDA078128 American Health Packaging ZIDOVUDINE 100 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68084-462_57e893ce-b303-57d4-e053-2991aa0a6145 68084-462 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET, FILM COATED ORAL 20110103 20180630 ANDA ANDA077267 American Health Packaging ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68084-463_5d151b20-d455-26d6-e053-2991aa0aff77 68084-463 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE ORAL 20110128 ANDA ANDA040833 American Health Packaging ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 68084-466_593f997d-f419-24ec-e053-2991aa0a4716 68084-466 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20110412 ANDA ANDA075576 American Health Packaging OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68084-469_58b369ac-6870-5701-e053-2991aa0a1ae6 68084-469 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20110401 ANDA ANDA040761 American Health Packaging HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68084-472_5f8b87f5-2957-6220-e053-2991aa0a3a21 68084-472 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20110331 ANDA ANDA078439 American Health Packaging HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-479_441c6b9e-db0c-12f8-e054-00144ff88e88 68084-479 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20130726 ANDA ANDA077728 American Health Packaging CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 68084-480_5a9374cb-2e7e-695e-e053-2991aa0aa9c1 68084-480 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20120110 ANDA ANDA078503 American Health Packaging OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68084-481_5b3532d9-4bb8-10cc-e053-2a91aa0a7013 68084-481 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110310 ANDA ANDA078424 American Health Packaging LEVOFLOXACIN 250 mg/1 N 20181231 68084-482_5b3532d9-4bb8-10cc-e053-2a91aa0a7013 68084-482 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110310 ANDA ANDA078424 American Health Packaging LEVOFLOXACIN 500 mg/1 N 20181231 68084-483_5b3532d9-4bb8-10cc-e053-2a91aa0a7013 68084-483 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110310 ANDA ANDA078424 American Health Packaging LEVOFLOXACIN 750 mg/1 N 20181231 68084-487_5b36d8b4-c1c3-82a6-e053-2991aa0a0cda 68084-487 HUMAN PRESCRIPTION DRUG bisoprolol fumarate bisoprolol fumarate TABLET, COATED ORAL 20111010 ANDA ANDA075643 American Health Packaging BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68084-490_5c74f211-db0c-18d2-e053-2a91aa0a76c0 68084-490 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20110718 ANDA ANDA201451 American Health Packaging MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 68084-491_5c74f211-db0c-18d2-e053-2a91aa0a76c0 68084-491 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20110714 ANDA ANDA201451 American Health Packaging MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 68084-494_5d56745d-beb4-f9fd-e053-2a91aa0a9668 68084-494 HUMAN PRESCRIPTION DRUG Pyridostigmine Bromide PYRIDOSTIGMINE BROMIDE TABLET ORAL 20110927 ANDA ANDA040502 American Health Packaging PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68084-499_57e882b8-6ccd-1aae-e053-2a91aa0a2fe4 68084-499 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20110901 20181231 ANDA ANDA040653 American Health Packaging GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68084-501_559efa5b-917e-2b52-e054-00144ff88e88 68084-501 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20110901 20180331 ANDA ANDA077751 American Health Packaging PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68084-502_559efa5b-917e-2b52-e054-00144ff88e88 68084-502 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20110901 20180331 ANDA ANDA077751 American Health Packaging PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68084-511_3bdc32df-e43c-1c21-e054-00144ff88e88 68084-511 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20110502 ANDA ANDA078103 American Health Packaging SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68084-512_3bdc32df-e43c-1c21-e054-00144ff88e88 68084-512 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20110502 ANDA ANDA078103 American Health Packaging SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68084-513_3bdc32df-e43c-1c21-e054-00144ff88e88 68084-513 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20110502 20180228 ANDA ANDA078103 American Health Packaging SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68084-519_591873c4-e676-550f-e053-2991aa0a99b7 68084-519 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20110915 20181031 ANDA ANDA077912 American Health Packaging HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-520_58af1a75-4acf-0506-e053-2991aa0a738f 68084-520 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20110919 20180731 ANDA ANDA086242 American Health Packaging HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68084-523_5d0320c8-f769-7be4-e053-2a91aa0a1466 68084-523 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111122 ANDA ANDA078179 American Health Packaging ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 68084-524_59147967-3065-8223-e053-2991aa0a4085 68084-524 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110913 NDA AUTHORIZED GENERIC NDA018279 American Health Packaging POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68084-525_4714d863-dbfe-27f9-e054-00144ff88e88 68084-525 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120425 ANDA ANDA076255 American Health Packaging OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-528_5b5c101f-8978-3f8a-e053-2a91aa0a4d38 68084-528 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120201 ANDA ANDA076133 American Health Packaging OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-529_5b5c101f-8978-3f8a-e053-2a91aa0a4d38 68084-529 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20120201 ANDA ANDA076133 American Health Packaging OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-530_5e1ffb20-1d7f-e62f-e053-2a91aa0a1570 68084-530 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 20190131 ANDA ANDA077380 American Health Packaging QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-531_5e1ffb20-1d7f-e62f-e053-2a91aa0a1570 68084-531 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 20190131 ANDA ANDA077380 American Health Packaging QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-532_5e1ffb20-1d7f-e62f-e053-2a91aa0a1570 68084-532 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 20190131 ANDA ANDA077380 American Health Packaging QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-533_5e1ffb20-1d7f-e62f-e053-2a91aa0a1570 68084-533 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 20180630 ANDA ANDA077380 American Health Packaging QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-534_5e1ffb20-1d7f-e62f-e053-2a91aa0a1570 68084-534 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 20180630 ANDA ANDA077380 American Health Packaging QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-535_5e1ffb20-1d7f-e62f-e053-2a91aa0a1570 68084-535 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20120402 20180630 ANDA ANDA077380 American Health Packaging QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-536_5abe5305-8ced-6e6e-e053-2991aa0ae516 68084-536 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel bisulfate TABLET, FILM COATED ORAL 20140314 ANDA ANDA076274 American Health Packaging CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68084-538_5d55e4bd-39de-30d9-e053-2991aa0a6a5c 68084-538 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20120501 20180731 ANDA ANDA200265 American Health Packaging VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68084-539_229ee218-e3d5-170e-e054-00144ff88e88 68084-539 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20130722 ANDA ANDA079234 American Health Packaging TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68084-540_5b1f4c78-d41e-32c7-e053-2991aa0a1985 68084-540 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20110901 ANDA ANDA075442 American Health Packaging FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 68084-541_21fda613-cc20-34c8-e054-00144ff88e88 68084-541 HUMAN PRESCRIPTION DRUG AcetaZOLAMIDE Acetazolamide TABLET ORAL 20111101 ANDA ANDA084840 American Health Packaging ACETAZOLAMIDE 250 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] E 20171231 68084-549_5de3f56b-3b65-c2ee-e053-2a91aa0accdf 68084-549 HUMAN PRESCRIPTION DRUG TEMAZEPAM temazepam CAPSULE ORAL 20120730 NDA NDA018163 American Health Packaging TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68084-550_43401362-8e25-1f5d-e054-00144ff8d46c 68084-550 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20120106 ANDA ANDA077131 American Health Packaging RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68084-552_5825df7a-98a8-2b48-e053-2a91aa0a8922 68084-552 HUMAN PRESCRIPTION DRUG Ketoconazole ketoconazole TABLET ORAL 20120120 ANDA ANDA075597 American Health Packaging KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68084-555_59185322-8d54-2bae-e053-2991aa0aab17 68084-555 HUMAN PRESCRIPTION DRUG Omeprazole omeprazole CAPSULE, DELAYED RELEASE ORAL 20120102 20180531 ANDA ANDA075410 American Health Packaging OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68084-558_52546e47-293b-4547-e054-00144ff88e88 68084-558 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20120131 20180430 ANDA ANDA075828 American Health Packaging LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68084-559_52546e47-293b-4547-e054-00144ff88e88 68084-559 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20120103 ANDA ANDA075828 American Health Packaging LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68084-561_5bebf59d-f3c5-7374-e053-2a91aa0a7306 68084-561 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 20120105 NDA AUTHORIZED GENERIC NDA020234 American Health Packaging CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 68084-562_5bebf59d-f3c5-7374-e053-2a91aa0a7306 68084-562 HUMAN PRESCRIPTION DRUG Carbamazepine ER Carbamazepine TABLET, EXTENDED RELEASE ORAL 20120105 NDA AUTHORIZED GENERIC NDA020234 American Health Packaging CARBAMAZEPINE 400 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 68084-572_2914ec4a-5e68-3b20-e054-00144ff8d46c 68084-572 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160101 NDA NDA021282 American Health Packaging GUAIFENESIN 600 mg/1 N 20181231 68084-578_5df7f9ca-6eaf-4d16-e053-2a91aa0aa619 68084-578 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20120217 ANDA ANDA202032 American Health Packaging LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68084-590_587752ba-fcbf-3171-e053-2991aa0a0878 68084-590 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20121101 ANDA ANDA090548 American Health Packaging ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68084-591_598fb6f0-3ceb-6dfd-e053-2991aa0a19f9 68084-591 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130304 ANDA ANDA075155 American Health Packaging ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68084-592_598fb6f0-3ceb-6dfd-e053-2991aa0a19f9 68084-592 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130304 ANDA ANDA075155 American Health Packaging ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68084-597_58228b80-f427-e322-e053-2991aa0a4e9f 68084-597 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120501 ANDA ANDA077127 American Health Packaging NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68084-598_58228b80-f427-e322-e053-2991aa0a4e9f 68084-598 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120501 ANDA ANDA077127 American Health Packaging NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68084-602_5e1f1bbe-3ce5-05ae-e053-2991aa0a978b 68084-602 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20120726 ANDA ANDA040226 American Health Packaging PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68084-603_58228b80-f427-e322-e053-2991aa0a4e9f 68084-603 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120501 ANDA ANDA077410 American Health Packaging NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68084-604_53bb364d-f943-2af8-e054-00144ff8d46c 68084-604 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20121008 ANDA ANDA076470 American Health Packaging DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 68084-605_5c51b471-253a-46fc-e053-2a91aa0a25f4 68084-605 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20130121 ANDA ANDA078619 American Health Packaging FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-606_53bb364d-f943-2af8-e054-00144ff8d46c 68084-606 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20121008 ANDA ANDA076470 American Health Packaging DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 68084-607_5e1f1bbe-3ce5-05ae-e053-2991aa0a978b 68084-607 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20120524 ANDA ANDA040226 American Health Packaging PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68084-608_26e01062-ae28-5207-e054-00144ff88e88 68084-608 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20120903 ANDA ANDA071196 American Health Packaging TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68084-610_5a9374cb-2e7e-695e-e053-2991aa0aa9c1 68084-610 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20120831 ANDA ANDA078503 American Health Packaging OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68084-611_4d11f415-6ae0-277b-e054-00144ff8d46c 68084-611 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 20130201 ANDA ANDA071293 American Health Packaging AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 68084-617_570767a9-c8b8-3faf-e054-00144ff8d46c 68084-617 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20121001 ANDA ANDA090432 American Health Packaging ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-618_570767a9-c8b8-3faf-e054-00144ff8d46c 68084-618 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20121001 ANDA ANDA090432 American Health Packaging ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-621_5bd50c3e-0eb4-e44d-e053-2a91aa0a62c1 68084-621 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20130529 ANDA ANDA202566 American Health Packaging MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 68084-623_4d9d4306-f39d-729c-e054-00144ff8d46c 68084-623 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20120930 20181231 ANDA ANDA063065 American Health Packaging MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68084-632_d39bf414-6b68-43f9-8b55-b433a38ffe0a 68084-632 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20130118 ANDA ANDA075604 American Health Packaging POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68084-635_5420182b-bbfd-5828-e054-00144ff8d46c 68084-635 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20130115 ANDA ANDA090856 American Health Packaging FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68084-636_5420182b-bbfd-5828-e054-00144ff8d46c 68084-636 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20130115 ANDA ANDA090856 American Health Packaging FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68084-639_492002c2-3d18-5746-e054-00144ff88e88 68084-639 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20141215 20180228 ANDA ANDA077869 American Health Packaging ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68084-640_4c07c316-2af7-42ec-e054-00144ff8d46c 68084-640 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20141001 ANDA ANDA076832 American Health Packaging LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 68084-642_5d55e4bd-39de-30d9-e053-2991aa0a6a5c 68084-642 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20140107 20180930 ANDA ANDA200265 American Health Packaging VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68084-643_5877429b-191c-9963-e053-2991aa0aa1b0 68084-643 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130826 ANDA ANDA078281 American Health Packaging PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68084-645_5c61bb54-feb0-100e-e053-2a91aa0a5135 68084-645 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20130911 ANDA ANDA076286 American Health Packaging TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68084-647_ed63f206-d8e3-4ea6-ba76-8a4bef93d982 68084-647 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20130904 ANDA ANDA074112 American Health Packaging ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 68084-651_5d928949-086c-078e-e053-2991aa0a74ee 68084-651 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20140416 ANDA ANDA065136 American Health Packaging CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68084-654_3461126c-9746-4ef9-e054-00144ff88e88 68084-654 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20140318 ANDA ANDA076140 American Health Packaging SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 68084-655_5d067770-171a-0fea-e053-2a91aa0afc63 68084-655 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20140103 ANDA ANDA076691 American Health Packaging LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] N 20181231 68084-658_57d50977-bb71-0b92-e053-2991aa0abc48 68084-658 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20131001 ANDA ANDA078558 American Health Packaging IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68084-659_5c763d0e-643b-4e0e-e053-2991aa0a538b 68084-659 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140421 ANDA ANDA090617 American Health Packaging METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68084-666_5c763d0e-643b-4e0e-e053-2991aa0a538b 68084-666 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140227 ANDA ANDA090617 American Health Packaging METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68084-672_ed63f206-d8e3-4ea6-ba76-8a4bef93d982 68084-672 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20130904 ANDA ANDA074112 American Health Packaging ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 68084-673_5c76f229-647b-b35d-e053-2a91aa0a3692 68084-673 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140508 ANDA ANDA078889 American Health Packaging METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68084-675_5e0b90d8-37e5-37bf-e053-2991aa0a70e1 68084-675 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131217 ANDA ANDA090694 American Health Packaging DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-676_5d1501a6-66c4-8462-e053-2991aa0a8c17 68084-676 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20160113 ANDA ANDA070581 American Health Packaging METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 68084-680_62d85069-36ee-8ffc-e053-2a91aa0a8085 68084-680 HUMAN PRESCRIPTION DRUG Digoxin DIGOXIN TABLET ORAL 20140922 ANDA ANDA078556 American Health Packaging DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20191231 68084-683_5e0b90d8-37e5-37bf-e053-2991aa0a70e1 68084-683 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131217 ANDA ANDA090694 American Health Packaging DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-692_5e0b90d8-37e5-37bf-e053-2991aa0a70e1 68084-692 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131217 ANDA ANDA090694 American Health Packaging DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-697_582286ec-df58-5105-e053-2a91aa0a1439 68084-697 HUMAN PRESCRIPTION DRUG BuPROPion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150323 ANDA ANDA079095 American Health Packaging BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68084-698_570ac9c9-f13c-336d-e054-00144ff88e88 68084-698 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140115 ANDA ANDA200834 American Health Packaging VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-699_5d7e292c-0c85-1755-e053-2a91aa0aaa74 68084-699 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20140616 ANDA ANDA202677 American Health Packaging OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-703_57d50977-bb71-0b92-e053-2991aa0abc48 68084-703 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20131014 ANDA ANDA078558 American Health Packaging IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68084-704_604f4dfb-faac-3940-e053-2991aa0aef80 68084-704 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20150205 ANDA ANDA040855 American Health Packaging BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20191231 68084-708_582286ec-df58-5105-e053-2a91aa0a1439 68084-708 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150401 ANDA ANDA079095 American Health Packaging BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68084-709_570ac9c9-f13c-336d-e054-00144ff88e88 68084-709 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140515 ANDA ANDA200834 American Health Packaging VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-710_5d7e292c-0c85-1755-e053-2a91aa0aaa74 68084-710 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20140617 ANDA ANDA202677 American Health Packaging OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-713_570ac9c9-f13c-336d-e054-00144ff88e88 68084-713 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140315 ANDA ANDA200834 American Health Packaging VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-717_60f289a3-878c-2310-e053-2991aa0aac25 68084-717 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20140725 20180930 ANDA ANDA077824 American Health Packaging RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68084-721_5bd50c3e-0eb4-e44d-e053-2a91aa0a62c1 68084-721 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20140530 ANDA ANDA202566 American Health Packaging MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 68084-722_5f86097f-0d52-8616-e053-2991aa0ab155 68084-722 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET, FILM COATED ORAL 20140325 ANDA ANDA202632 American Health Packaging MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68084-723_4714d863-dbfe-27f9-e054-00144ff88e88 68084-723 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140407 ANDA ANDA076255 American Health Packaging OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-727_591873c4-e676-550f-e053-2991aa0a99b7 68084-727 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140501 20180930 ANDA ANDA077912 American Health Packaging HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-728_5c60d7ac-877e-4b45-e053-2a91aa0a5c2f 68084-728 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20141022 ANDA ANDA077731 American Health Packaging FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68084-729_59b99c9f-5d22-7ebc-e053-2991aa0ac1a0 68084-729 HUMAN PRESCRIPTION DRUG Galantamine Galantamine TABLET, FILM COATED ORAL 20140601 ANDA ANDA090957 American Health Packaging GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68084-735_5c60d7ac-877e-4b45-e053-2a91aa0a5c2f 68084-735 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140813 ANDA ANDA077731 American Health Packaging FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68084-736_1af0c69a-b2cb-4f50-af82-523871bae961 68084-736 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140401 ANDA ANDA071403 American Health Packaging LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68084-737_580dce3a-c80a-0a26-e053-2991aa0a5213 68084-737 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20140401 ANDA ANDA077031 American Health Packaging CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-738_44184490-34c4-0d86-e054-00144ff8d46c 68084-738 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 20141002 ANDA ANDA090635 American Health Packaging METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-740_4714d863-dbfe-27f9-e054-00144ff88e88 68084-740 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140407 ANDA ANDA076255 American Health Packaging OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 68084-742_1af0c69a-b2cb-4f50-af82-523871bae961 68084-742 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140401 ANDA ANDA071404 American Health Packaging LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68084-743_57d5fa8d-3579-9e2c-e053-2a91aa0a0b23 68084-743 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20140512 ANDA ANDA065055 American Health Packaging DOXYCYCLINE 100 mg/1 N 20181231 68084-744_580dce3a-c80a-0a26-e053-2991aa0a5213 68084-744 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20140401 ANDA ANDA077031 American Health Packaging CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-746_559efa5b-917e-2b52-e054-00144ff88e88 68084-746 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20140430 20180630 ANDA ANDA077751 American Health Packaging PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68084-747_4714dec5-ba87-4aa0-e054-00144ff8d46c 68084-747 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140530 ANDA ANDA076899 American Health Packaging SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68084-748_26e01062-ae07-5207-e054-00144ff88e88 68084-748 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine Hydrochloride TABLET ORAL 20140530 ANDA ANDA075109 American Health Packaging GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68084-750_29149266-62b4-2002-e054-00144ff8d46c 68084-750 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20140530 ANDA ANDA071251 American Health Packaging TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68084-752_5abe5305-8ced-6e6e-e053-2991aa0ae516 68084-752 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel bisulfate TABLET, FILM COATED ORAL 20140328 ANDA ANDA076274 American Health Packaging CLOPIDOGREL BISULFATE 300 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68084-753_2790c70c-1d35-003b-e054-00144ff88e88 68084-753 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140530 ANDA ANDA078048 American Health Packaging CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68084-754_1af0c69a-b2cb-4f50-af82-523871bae961 68084-754 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140401 ANDA ANDA071141 American Health Packaging LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68084-755_59186a72-3a3f-4b1b-e053-2a91aa0a56e1 68084-755 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20140410 20180531 ANDA ANDA074501 American Health Packaging NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68084-756_5b389615-c4ef-b218-e053-2a91aa0ac464 68084-756 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20140508 ANDA ANDA090860 American Health Packaging NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 68084-758_5918fd18-0ac7-f1a0-e053-2991aa0a3e26 68084-758 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20140520 20180531 ANDA ANDA091264 American Health Packaging LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 68084-762_59781535-29cc-e64d-e053-2a91aa0adfcd 68084-762 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140925 ANDA ANDA075350 American Health Packaging GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-763_59186a72-3a3f-4b1b-e053-2a91aa0a56e1 68084-763 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20140410 20180331 ANDA ANDA074501 American Health Packaging NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68084-764_2eb9a41e-ceab-1e94-e054-00144ff8d46c 68084-764 HUMAN PRESCRIPTION DRUG Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate TABLET ORAL 20140602 UNAPPROVED DRUG OTHER American Health Packaging SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 852; 155; 130 mg/1; mg/1; mg/1 N 20181231 68084-765_5e99029f-7e36-781e-e053-2991aa0a49c4 68084-765 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20140602 ANDA ANDA077321 American Health Packaging LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-766_591873c4-e676-550f-e053-2991aa0a99b7 68084-766 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20140510 20180731 ANDA ANDA077912 American Health Packaging HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-772_57d50977-bb71-0b92-e053-2991aa0abc48 68084-772 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20131014 ANDA ANDA078558 American Health Packaging IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68084-773_5b389615-c4ef-b218-e053-2a91aa0ac464 68084-773 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20140925 ANDA ANDA090446 American Health Packaging NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 68084-774_59781535-29cc-e64d-e053-2a91aa0adfcd 68084-774 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140617 ANDA ANDA075350 American Health Packaging GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-775_5c61bb54-feb0-100e-e053-2a91aa0a5135 68084-775 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20140521 ANDA ANDA076286 American Health Packaging TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68084-776_60525050-9c4a-3019-e053-2a91aa0a842a 68084-776 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141007 ANDA ANDA090554 American Health Packaging DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68084-777_589eb7d5-24aa-5e1e-e053-2a91aa0a3d49 68084-777 HUMAN OTC DRUG Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140815 ANDA ANDA076200 American Health Packaging ACETAMINOPHEN 650 mg/1 N 20181231 68084-779_639ad41c-8f8b-967a-e053-2a91aa0aa567 68084-779 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20140718 20181031 ANDA ANDA077030 American Health Packaging CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20191231 68084-782_60525050-9c4a-3019-e053-2a91aa0a842a 68084-782 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20141029 ANDA ANDA090554 American Health Packaging DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68084-783_59781535-29cc-e64d-e053-2a91aa0adfcd 68084-783 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140812 ANDA ANDA075350 American Health Packaging GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-785_575b07bb-d146-d09d-e053-2991aa0ab5ec 68084-785 HUMAN PRESCRIPTION DRUG Doxycycline Monohydrate doxycycline TABLET ORAL 20150915 20180831 ANDA ANDA065070 American Health Packaging DOXYCYCLINE 100 mg/1 N 20181231 68084-788_57fc77dc-c76d-ef19-e053-2a91aa0adfde 68084-788 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20140730 ANDA ANDA077091 American Health Packaging GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68084-789_58b369ac-6870-5701-e053-2991aa0a1ae6 68084-789 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20140616 ANDA ANDA040761 American Health Packaging HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68084-790_5f375a47-2961-6465-e053-2a91aa0a2149 68084-790 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 20140829 ANDA ANDA074694 American Health Packaging CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68084-793_5f4a16fd-0114-0665-e053-2a91aa0ac4a1 68084-793 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20140805 ANDA ANDA078920 American Health Packaging PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68084-795_4e8f4a92-84f0-1a18-e054-00144ff8d46c 68084-795 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20141215 ANDA ANDA065379 American Health Packaging MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 68084-797_5a54dca4-bec9-8cf3-e053-2991aa0afb17 68084-797 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20141111 ANDA ANDA078926 American Health Packaging GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-799_559e14c5-6849-15ba-e054-00144ff88e88 68084-799 HUMAN PRESCRIPTION DRUG Balsalazide Disodium Balsalazide Disodium CAPSULE ORAL 20140727 20180731 ANDA ANDA077883 American Health Packaging BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 68084-801_57fe4ae0-a32f-66bc-e053-2a91aa0ab60c 68084-801 HUMAN PRESCRIPTION DRUG Mycophenolate mofetil Mycophenolate mofetil TABLET ORAL 20141215 ANDA ANDA065451 American Health Packaging MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 68084-802_5a54dca4-bec9-8cf3-e053-2991aa0afb17 68084-802 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20140827 ANDA ANDA078926 American Health Packaging GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-803_432c84ac-d161-575b-e054-00144ff8d46c 68084-803 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20140820 ANDA ANDA091303 American Health Packaging LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 68084-805_5cc6cec2-9edc-6cf9-e053-2991aa0ada77 68084-805 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20140731 ANDA ANDA040300 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68084-808_345f7892-daeb-546f-e054-00144ff8d46c 68084-808 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20140821 ANDA ANDA076003 American Health Packaging TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68084-810_5de17d65-565c-c740-e053-2a91aa0aff87 68084-810 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20140828 ANDA ANDA077633 American Health Packaging LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68084-813_5877429b-191c-9963-e053-2991aa0aa1b0 68084-813 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20141115 ANDA ANDA078281 American Health Packaging PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68084-816_bdf7b7da-f152-4f59-8951-a871312a009b 68084-816 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20140903 NDA AUTHORIZED GENERIC NDA021121 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68084-818_5f375a47-2961-6465-e053-2a91aa0a2149 68084-818 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 20140915 ANDA ANDA074694 American Health Packaging CLOMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68084-820_57fdda3a-f947-3164-e053-2991aa0a9ac7 68084-820 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 20140915 ANDA ANDA040368 American Health Packaging ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68084-823_5cc6cec2-9edc-6cf9-e053-2991aa0ada77 68084-823 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20140731 ANDA ANDA040300 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68084-825_8b1fb6f9-e3fa-487a-9bda-6885281c8e17 68084-825 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED ORAL 20140821 ANDA ANDA077184 American Health Packaging TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68084-827_5b1f8da0-bc82-a031-e053-2991aa0a60e8 68084-827 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20140915 ANDA ANDA076509 American Health Packaging FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68084-828_5c73b903-8819-b68e-e053-2a91aa0aaa35 68084-828 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20140925 ANDA ANDA077290 American Health Packaging OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68084-829_bdf7b7da-f152-4f59-8951-a871312a009b 68084-829 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20140903 NDA AUTHORIZED GENERIC NDA021121 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68084-830_5e1f1bbe-3ce5-05ae-e053-2991aa0a978b 68084-830 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20140910 ANDA ANDA040226 American Health Packaging PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68084-833_bdf7b7da-f152-4f59-8951-a871312a009b 68084-833 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20140904 NDA AUTHORIZED GENERIC NDA021121 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68084-835_58fea1ef-d55d-fbc3-e053-2991aa0a4871 68084-835 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20141001 ANDA ANDA075868 American Health Packaging FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68084-836_5f9f08e7-b0fc-4b59-e053-2991aa0a1f10 68084-836 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20140922 ANDA ANDA075580 American Health Packaging DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68084-841_5bc16486-fb03-57f7-e053-2a91aa0a68df 68084-841 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20140915 ANDA ANDA076642 American Health Packaging HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20181231 68084-842_5e1f1bbe-3ce5-05ae-e053-2991aa0a978b 68084-842 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20141008 ANDA ANDA040226 American Health Packaging PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68084-843_602b2124-a8d4-0bd0-e053-2a91aa0a7acc 68084-843 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20150219 ANDA ANDA077614 American Health Packaging CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68084-844_5fc2700c-2c69-5b96-e053-2a91aa0ac524 68084-844 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20150417 ANDA ANDA077653 American Health Packaging VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-845_5b5fddb5-b799-ff07-e053-2991aa0aa89a 68084-845 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20141104 ANDA ANDA078069 American Health Packaging OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-846_5c8c1532-93a0-8bb1-e053-2991aa0a3dfc 68084-846 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20141003 ANDA ANDA089742 American Health Packaging FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68084-847_4e1211a6-e65b-5901-e054-00144ff8d46c 68084-847 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20150201 ANDA ANDA087479 American Health Packaging HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68084-848_2eb98cd8-33ce-206b-e054-00144ff8d46c 68084-848 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength TABLET ORAL 20140918 OTC MONOGRAPH FINAL part343 American Health Packaging ASPIRIN 325 mg/1 N 20181231 68084-850_ad39bed0-b723-4d0b-a238-46737420d6d1 68084-850 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20141001 ANDA ANDA203546 American Health Packaging POTASSIUM CITRATE 10 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 68084-851_5f9f08e7-b0fc-4b59-e053-2991aa0a1f10 68084-851 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20140922 ANDA ANDA075580 American Health Packaging DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68084-853_5b5fddb5-b799-ff07-e053-2991aa0aa89a 68084-853 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20141105 ANDA ANDA078069 American Health Packaging OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-854_602b2124-a8d4-0bd0-e053-2a91aa0a7acc 68084-854 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20150518 ANDA ANDA077614 American Health Packaging CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68084-855_5887d86f-0075-2103-e053-2a91aa0a4688 68084-855 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20150215 ANDA ANDA077241 American Health Packaging BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68084-856_5fc2700c-2c69-5b96-e053-2a91aa0ac524 68084-856 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20150306 ANDA ANDA077653 American Health Packaging VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-859_6029b802-a208-6f28-e053-2991aa0a31d3 68084-859 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20150203 ANDA ANDA078993 American Health Packaging LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-860_5cc6cec2-9edc-6cf9-e053-2991aa0ada77 68084-860 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET ORAL 20140731 20180930 ANDA ANDA040300 American Health Packaging METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68084-862_5f9f08e7-b0fc-4b59-e053-2991aa0a1f10 68084-862 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20140922 ANDA ANDA075580 American Health Packaging DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68084-863_60672be6-328d-6330-e053-2a91aa0abb54 68084-863 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20141002 ANDA ANDA040656 American Health Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 68084-865_602b2124-a8d4-0bd0-e053-2a91aa0a7acc 68084-865 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20150331 ANDA ANDA077614 American Health Packaging CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68084-866_5e980e0d-c7eb-47a8-e053-2a91aa0a1bf3 68084-866 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Extended-Release Clonidine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20141027 ANDA ANDA202984 American Health Packaging CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68084-867_5b5fddb5-b799-ff07-e053-2991aa0aa89a 68084-867 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20141203 ANDA ANDA078069 American Health Packaging OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-868_5887d86f-0075-2103-e053-2a91aa0a4688 68084-868 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20150215 ANDA ANDA077241 American Health Packaging BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68084-869_4f457a86-b899-5b53-e054-00144ff8d46c 68084-869 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET ORAL 20150215 ANDA ANDA202025 American Health Packaging SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 68084-870_6029b802-a208-6f28-e053-2991aa0a31d3 68084-870 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20150209 ANDA ANDA078993 American Health Packaging LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-872_5d80209d-0ab5-d041-e053-2991aa0a0fa4 68084-872 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol CAPSULE ORAL 20160114 ANDA ANDA091433 American Health Packaging DOXERCALCIFEROL .5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 68084-875_5d1a4ba1-3fe5-13d2-e053-2991aa0af7da 68084-875 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, COATED ORAL 20150402 ANDA ANDA201582 American Health Packaging MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68084-876_602b2124-a8d4-0bd0-e053-2a91aa0a7acc 68084-876 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20150407 ANDA ANDA077614 American Health Packaging CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68084-878_55a2e8eb-3535-6ce4-e054-00144ff8d46c 68084-878 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20150715 ANDA ANDA076798 American Health Packaging PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 68084-879_5babb86c-d12a-564b-e053-2a91aa0ab47f 68084-879 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, GELATIN COATED ORAL 20150930 ANDA ANDA065040 American Health Packaging CYCLOSPORINE 25 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68084-882_6029b802-a208-6f28-e053-2991aa0a31d3 68084-882 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20150309 ANDA ANDA078993 American Health Packaging LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-883_61e68e61-05ba-12df-e053-2a91aa0ae5fb 68084-883 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, EXTENDED RELEASE ORAL 20141215 20180930 ANDA ANDA200815 American Health Packaging FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 68084-884_6441558e-2cf4-b37d-e053-2991aa0adf50 68084-884 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140926 ANDA ANDA040148 American Health Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 68084-886_63226978-31f3-62a9-e053-2991aa0af510 68084-886 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20150818 20190331 ANDA ANDA076449 American Health Packaging MIDODRINE HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20191231 68084-889_5d0320c8-f769-7be4-e053-2a91aa0a1466 68084-889 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160413 20180630 ANDA ANDA078179 American Health Packaging ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 68084-892_5b9bb1ba-06e2-4a06-999b-84d0841df110 68084-892 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20141215 ANDA ANDA200826 American Health Packaging URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 68084-893_6029b802-a208-6f28-e053-2991aa0a31d3 68084-893 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20150310 ANDA ANDA078993 American Health Packaging LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68084-894_09d7bbe7-23e2-43b2-904b-02d78b57273b 68084-894 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20150915 ANDA ANDA086221 American Health Packaging ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68084-895_60645d87-418b-d7b0-e053-2991aa0ae7d7 68084-895 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141010 ANDA ANDA040736 American Health Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 68084-896_5fc2700c-2c69-5b96-e053-2a91aa0ac524 68084-896 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20150215 ANDA ANDA077653 American Health Packaging VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-897_4fa443eb-e29e-69e1-e054-00144ff8d46c 68084-897 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20160301 20180731 ANDA ANDA074501 American Health Packaging NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68084-899_5d6af229-f72a-4234-e053-2991aa0aac07 68084-899 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20151022 ANDA ANDA077690 American Health Packaging QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68084-900_5fc2700c-2c69-5b96-e053-2a91aa0ac524 68084-900 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20150215 20181130 ANDA ANDA077653 American Health Packaging VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-905_5fc2700c-2c69-5b96-e053-2a91aa0ac524 68084-905 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20151019 ANDA ANDA077653 American Health Packaging VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68084-907_602d10fc-10b6-c1dd-e053-2a91aa0a675e 68084-907 HUMAN PRESCRIPTION DRUG Mycophenolic Acid Mycophenolic Acid TABLET, DELAYED RELEASE ORAL 20150202 ANDA ANDA091558 American Health Packaging MYCOPHENOLATE SODIUM 180 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 68084-908_5cc44dca-00d9-b589-e053-2a91aa0a0521 68084-908 HUMAN PRESCRIPTION DRUG RILUZOLE RILUZOLE TABLET, FILM COATED ORAL 20150331 ANDA ANDA091300 American Health Packaging RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] N 20181231 68084-912_5657e8e7-70ff-4033-e054-00144ff88e88 68084-912 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE, LIQUID FILLED ORAL 20150215 ANDA ANDA090103 American Health Packaging NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68084-915_5e1e55d1-cba1-e5c3-e053-2991aa0a794b 68084-915 HUMAN PRESCRIPTION DRUG Sirolimus Sirolimus TABLET ORAL 20151130 ANDA ANDA201578 American Health Packaging SIROLIMUS 1 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 68084-917_5e343262-ef4f-2d58-e053-2991aa0a0dd3 68084-917 HUMAN PRESCRIPTION DRUG Propafenone Hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20151102 ANDA ANDA078540 American Health Packaging PROPAFENONE HYDROCHLORIDE 325 mg/1 Antiarrhythmic [EPC] N 20181231 68084-918_602d10fc-10b6-c1dd-e053-2a91aa0a675e 68084-918 HUMAN PRESCRIPTION DRUG Mycophenolic Acid Mycophenolic Acid TABLET, DELAYED RELEASE ORAL 20150330 ANDA ANDA091558 American Health Packaging MYCOPHENOLATE SODIUM 360 mg/1 Antimetabolite Immunosuppressant [EPC] N 20181231 68084-920_4fa443eb-e2d4-69e1-e054-00144ff8d46c 68084-920 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20150201 20180228 ANDA ANDA065150 American Health Packaging AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68084-921_5babb86c-d12a-564b-e053-2a91aa0ab47f 68084-921 HUMAN PRESCRIPTION DRUG Cyclosporine Cyclosporine CAPSULE, GELATIN COATED ORAL 20151103 ANDA ANDA065040 American Health Packaging CYCLOSPORINE 100 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68084-923_5e331ad2-675d-5e76-e053-2a91aa0a823c 68084-923 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE, LIQUID FILLED ORAL 20151130 ANDA ANDA072556 American Health Packaging NIFEDIPINE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68084-924_60f26260-8cbd-c309-e053-2a91aa0af844 68084-924 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20160503 20180731 ANDA ANDA070929 American Health Packaging TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 68084-928_20d40482-9dea-26e3-e054-00144ff88e88 68084-928 HUMAN PRESCRIPTION DRUG Pilocarpine hydrochloride Pilocarpine hydrochloride TABLET, FILM COATED ORAL 20150901 NDA AUTHORIZED GENERIC NDA020237 American Health Packaging PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 68084-929_5d1a41b6-d0af-5ddb-e053-2a91aa0a382a 68084-929 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid TABLET, FILM COATED ORAL 20151218 ANDA ANDA202093 American Health Packaging TRANEXAMIC ACID 650 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 68084-930_58b369ac-6870-5701-e053-2991aa0a1ae6 68084-930 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20150301 ANDA ANDA040761 American Health Packaging HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68084-932_52641cb0-6591-6c5a-e054-00144ff88e88 68084-932 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride ER propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20151101 20180331 NDA AUTHORIZED GENERIC NDA018553 American Health Packaging PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68084-933_55d97d0a-5f1d-196c-e054-00144ff88e88 68084-933 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150331 20180630 ANDA ANDA078992 American Health Packaging DEXMETHYLPHENIDATE HYDROCHLORIDE 30 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68084-934_52546e47-291d-4547-e054-00144ff88e88 68084-934 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, and Caffeine butalbital, aspirin, and caffeine CAPSULE ORAL 20150331 20180930 NDA AUTHORIZED GENERIC NDA017534 American Health Packaging BUTALBITAL; ASPIRIN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 68084-935_60f26260-8cbd-c309-e053-2a91aa0af844 68084-935 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET ORAL 20160504 20180731 ANDA ANDA070929 American Health Packaging TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 68084-940_4fa432e7-cad5-5025-e054-00144ff88e88 68084-940 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20151201 20180831 NDA AUTHORIZED GENERIC NDA021802 American Health Packaging DEXMETHYLPHENIDATE HYDROCHLORIDE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68084-945_5cdcf5a0-6deb-5c05-e053-2a91aa0a7eca 68084-945 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET, FILM COATED ORAL 20151105 ANDA ANDA080966 American Health Packaging PROBENECID 500 mg/1 N 20181231 68084-946_491f8925-b257-3372-e054-00144ff8d46c 68084-946 HUMAN PRESCRIPTION DRUG Spironolactone and Hydrochlorothiazide Spironolactone and Hydrochlorothiazide TABLET ORAL 20150331 20180228 ANDA ANDA089534 American Health Packaging SPIRONOLACTONE; HYDROCHLOROTHIAZIDE 25; 25 mg/1; mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68084-947_283715dc-5d4e-6b86-e054-00144ff88e88 68084-947 HUMAN PRESCRIPTION DRUG Quinine Sulfate Quinine Sulfate CAPSULE ORAL 20150331 NDA AUTHORIZED GENERIC NDA021799 American Health Packaging QUININE SULFATE 324 mg/1 Antimalarial [EPC] N 20181231 68084-948_5c74fbf7-3b53-0d53-e053-2a91aa0a9710 68084-948 HUMAN PRESCRIPTION DRUG Eplerenone Eplerenone TABLET ORAL 20150824 ANDA ANDA078510 American Health Packaging EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68084-949_b0f73459-baeb-42a7-be48-2c3647d9b205 68084-949 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 20150901 ANDA ANDA072637 American Health Packaging ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68084-950_5c8c1532-93a0-8bb1-e053-2991aa0a3dfc 68084-950 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20151001 ANDA ANDA089743 American Health Packaging FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68084-952_b0f73459-baeb-42a7-be48-2c3647d9b205 68084-952 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 20150901 ANDA ANDA072637 American Health Packaging ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68084-954_5d6864a4-c31a-3f7d-e053-2a91aa0a5f4a 68084-954 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20150824 ANDA ANDA077571 American Health Packaging REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 68084-955_4fa45b28-c072-1880-e054-00144ff8d46c 68084-955 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20160315 20180831 ANDA ANDA075845 American Health Packaging OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68084-956_5e942b12-db6d-c1ab-e053-2991aa0ac8d3 68084-956 HUMAN PRESCRIPTION DRUG Sirolimus Sirolimus TABLET, FILM COATED ORAL 20150331 ANDA ANDA201676 American Health Packaging SIROLIMUS .5 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 68084-959_4d9d4306-f341-729c-e054-00144ff8d46c 68084-959 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150331 20180228 ANDA ANDA091629 American Health Packaging LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68084-960_575b07bb-d126-d09d-e053-2991aa0ab5ec 68084-960 HUMAN OTC DRUG Fiber-Caps Stimulant Free Fiber Laxative Calcium Polycarbophil CAPSULE ORAL 20150701 20180731 OTC MONOGRAPH NOT FINAL part334 American Health Packaging CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 68084-963_463bc470-ab83-3b7d-e054-00144ff88e88 68084-963 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20160510 20180228 ANDA ANDA200503 American Health Packaging TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68084-964_5889ca62-bff8-e115-e053-2991aa0a8b7c 68084-964 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 20150915 NDA NDA006188 American Health Packaging PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 68084-965_592ba66c-ed47-013f-e053-2991aa0a39e2 68084-965 HUMAN PRESCRIPTION DRUG Valganciclovir Valganciclovir TABLET, FILM COATED ORAL 20150101 ANDA ANDA203511 American Health Packaging VALGANCICLOVIR HYDROCHLORIDE 450 mg/1 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 68084-966_3816c009-2964-57c6-e054-00144ff88e88 68084-966 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150202 ANDA ANDA070044 American Health Packaging METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68084-967_5d6864a4-c31a-3f7d-e053-2a91aa0a5f4a 68084-967 HUMAN PRESCRIPTION DRUG Repaglinide Repaglinide TABLET ORAL 20150824 ANDA ANDA077571 American Health Packaging REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 68084-969_4f545d0f-0d77-3768-e054-00144ff88e88 68084-969 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150201 ANDA ANDA076898 American Health Packaging CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68084-972_5bd3464a-feb2-6aca-e053-2a91aa0aee00 68084-972 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20150824 ANDA ANDA072100 American Health Packaging DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68084-974_5f4a16fd-0114-0665-e053-2a91aa0ac4a1 68084-974 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20150331 ANDA ANDA078920 American Health Packaging PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68084-976_4f545d0f-0d77-3768-e054-00144ff88e88 68084-976 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150201 ANDA ANDA076898 American Health Packaging CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68084-982_5f4a16fd-0114-0665-e053-2a91aa0ac4a1 68084-982 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20150331 ANDA ANDA078920 American Health Packaging PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68084-988_5e94ddb4-dbcd-4512-e053-2991aa0ac96d 68084-988 HUMAN OTC DRUG Antacid Peppermint Flavour Regular Strength Calcium Carbonate TABLET, CHEWABLE ORAL 20151115 OTC MONOGRAPH FINAL part331 American Health Packaging CALCIUM CARBONATE 500 mg/1 N 20181231 68084-994_559e14c5-68bd-15ba-e054-00144ff88e88 68084-994 HUMAN OTC DRUG Antacid Assorted Berry Flavor Extra Strength Calcium Carbonate TABLET, CHEWABLE ORAL 20151115 20180930 OTC MONOGRAPH FINAL part331 American Health Packaging CALCIUM CARBONATE 750 mg/1 N 20181231 68085-8012_6bf15075-53a3-468f-be62-b90e56310ff9 68085-8012 HUMAN OTC DRUG Piyanping antiitch Hydrocortisone CREAM TOPICAL 20110416 OTC MONOGRAPH NOT FINAL part348 Guangdong Zhanjiang Jimin Pharmaceutical Company, Ltd. HYDROCORTISONE 1 g/100g E 20171231 68088-515_4de99e8e-1847-4283-85fa-d87a908f9963 68088-515 HUMAN OTC DRUG LANDRUM INSTANT HAND SANITIZER ethanol GEL TOPICAL 20100521 OTC MONOGRAPH NOT FINAL part333 Kentucky Technology LLC. ETHANOL 600 mL/1000mL E 20171231 68089-004_7d9a6eba-157f-4113-ae68-e96c4a86ac37 68089-004 HUMAN OTC DRUG Clear Sinus and Ear Pulsatilla Vulgaris, Euphorbia Resinifera Resin, Calcium Sulfate and Oyster Shell Calcium Carbonate, Crude CAPSULE ORAL 20080801 UNAPPROVED HOMEOPATHIC Clear Products, Inc. PULSATILLA VULGARIS; EUPHORBIA RESINIFERA RESIN; CALCIUM SULFATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE 3; 6; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 68093-4501_5f0c1b2c-d045-7aed-e053-2991aa0a4e8c 68093-4501 HUMAN OTC DRUG ENT Essentials All Dry Ear Drying Drops Isopropyl Alcohol LIQUID AURICULAR (OTIC) 20170201 OTC MONOGRAPH FINAL part344 Wisconsin Pharmacal Company ISOPROPYL ALCOHOL .95 g/100g N 20181231 68093-4503_5d7d078f-ef8b-8aa7-e053-2a91aa0ae3b1 68093-4503 HUMAN OTC DRUG ENT Essentials Ear Wax Remvoer Carbamide Peroxide LIQUID AURICULAR (OTIC) 20170201 OTC MONOGRAPH NOT FINAL part356 Wisconsin Pharmacal Company CARBAMIDE PEROXIDE .065 g/g N 20181231 68093-5105_5f0d0717-3ece-3aa7-e053-2991aa0a256e 68093-5105 HUMAN OTC DRUG MG217 Baby Eczema Colloidal Oatmeal LOTION TOPICAL 20160201 OTC MONOGRAPH FINAL part347 Wisconsin Pharmacal Company OATMEAL .02 g/g N 20181231 68093-5106_5f10a2eb-7531-4860-e053-2991aa0a8efc 68093-5106 HUMAN OTC DRUG MG217 Eczema Body Colloidal Oatmeal LOTION TOPICAL 20160301 OTC MONOGRAPH FINAL part347 Wisconsin Pharmacal Company OATMEAL .02 g/g N 20181231 68093-5206_a455e4f1-46ac-4453-92bc-c6847fe39535 68093-5206 HUMAN OTC DRUG MG217 Psoriasis Therapeutic Scalp Treatment Coal Tar SHAMPOO TOPICAL 20140701 OTC MONOGRAPH FINAL part358H Wisconsin Pharmacal Company COAL TAR .03 g/g N 20181231 68093-7038_8d3ba79a-399a-4e6f-9a74-f895edc41ccd 68093-7038 HUMAN OTC DRUG StingEze Insect Bite Relief Benzocaine, Phenol, Camphor LIQUID TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part348 Wisconsin Pharmacal Company BENZOCAINE; PHENOL; CAMPHOR (SYNTHETIC) .05; .0135; .03 g/g; g/g; g/g N 20181231 68093-7066_2d29b8ef-243f-37ac-e054-00144ff8d46c 68093-7066 HUMAN OTC DRUG StingEze with Aloe for kids Benzocaine, Benzalkonium Chloride LIQUID TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part348 Wisconsin Pharmacal Company CAMPHOR (SYNTHETIC); BENZOCAINE; BENZALKONIUM CHLORIDE .03; .05; .0013 g/g; g/g; g/g N 20181231 68093-7079_7e0c7c7b-6625-46cd-abd6-630d9c78f122 68093-7079 HUMAN OTC DRUG VH Essentials Sensitive Medicated Cream Benzocaine, Benzalkonium Chloride CREAM TOPICAL 20101201 OTC MONOGRAPH NOT FINAL part348 Wisconsin Pharmacal Company BENZOCAINE; BENZALKONIUM CHLORIDE .05; .0013 g/g; g/g N 20181231 68093-7120_89c233f2-863e-4e96-9ad7-a24336422d87 68093-7120 HUMAN OTC DRUG CVS Sore Muscle Rub Vanishing Scent Menthol CREAM TOPICAL 20080601 OTC MONOGRAPH FINAL part341 Wisconsin Pharmacal Company MENTHOL .025 g/g N 20181231 68093-7151_8354a619-f4ca-4a16-b040-352c7e47c0ed 68093-7151 HUMAN OTC DRUG StingEze Max Insect Bite Relief Benzocaine, Camphor, Phenol LIQUID TOPICAL 20090201 OTC MONOGRAPH NOT FINAL part348 Wisconsin Pharmacal Company BENZOCAINE; PHENOL; CAMPHOR (SYNTHETIC) .1; .0135; .03 g/g; g/g; g/g N 20181231 68093-7203_244a1452-5d59-3219-e054-00144ff88e88 68093-7203 HUMAN OTC DRUG MG217 Psoriasis Salicylic Acid SHAMPOO TOPICAL 20130901 OTC MONOGRAPH FINAL part333D Wisconsin Pharmacal Company SALICYLIC ACID .03 g/g N 20181231 68093-7207_0ae8ba89-7926-4b3d-8bdc-dee10f9e3092 68093-7207 HUMAN OTC DRUG MG217 Psoriasis Psoriasis Treatment Intensive Strength Coal Tar OINTMENT TOPICAL 20120601 OTC MONOGRAPH FINAL part358H Wisconsin Pharmacal Company COAL TAR .02 g/g N 20181231 68093-7208_2c2c395a-0b59-47b8-b973-eed29f2fedbc 68093-7208 HUMAN OTC DRUG MG217 Psoriasis Medicated Conditioning Coal Tar SHAMPOO TOPICAL 20120701 OTC MONOGRAPH FINAL part358H Wisconsin Pharmacal Company COAL TAR .03 g/g N 20181231 68093-7226_23e6429e-7c6d-4391-e054-00144ff88e88 68093-7226 HUMAN OTC DRUG MG217 Psoriasis Multi Symptom Coal Tar GEL TOPICAL 20140801 OTC MONOGRAPH FINAL part358H Wisconsin Pharmacal Company COAL TAR .02 g/g N 20181231 68093-7242_2e961928-db05-3cfd-e054-00144ff88e88 68093-7242 HUMAN OTC DRUG MG217 Psoriasis Therapeutic Conditioner Salicylic Acid SHAMPOO TOPICAL 20151101 OTC MONOGRAPH FINAL part333D Wisconsin Pharmacal Company SALICYLIC ACID .03 g/g N 20181231 68094-001_f193ac38-d9d9-4461-ab69-1677dd309e30 68094-001 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20160229 NDA NDA022195 Precision Dose Inc. MORPHINE SULFATE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68094-002_dffe7e85-0da1-463b-9638-cf1ed11615be 68094-002 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20170822 ANDA ANDA201658 Precision Dose, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 68094-004_ad976192-fd11-49d6-84f5-b619a78ef3ab 68094-004 HUMAN OTC DRUG Dye Free Childrens Cetirizine Hydrocholride Cetirizine Hydrochloride SOLUTION ORAL 20161026 ANDA ANDA204226 Precision Dose, Inc. CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 68094-005_d714a5e0-239d-4350-b0ad-b8aa259c6c3b 68094-005 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20161221 ANDA ANDA203638 Precision Dose, Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 68094-006_eb86dc4f-a9ca-43fb-8ca4-db6568a4a4da 68094-006 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20170601 ANDA ANDA203638 Precision Dose, Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68094-007_d31bfdad-7f96-4822-907f-b3fd12710de6 68094-007 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine SUSPENSION ORAL 20171004 ANDA ANDA075714 Precision Dose, Inc. CARBAMAZEPINE 100 mg/5mL Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 68094-008_d31bfdad-7f96-4822-907f-b3fd12710de6 68094-008 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine SUSPENSION ORAL 20171004 ANDA ANDA075714 Precision Dose, Inc. CARBAMAZEPINE 200 mg/10mL Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 68094-013_87a2f2ae-2539-4cb2-9067-0838e5a273ca 68094-013 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20170731 ANDA ANDA040777 Precision Dose, Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68094-015_6bd7d768-3924-4bff-a2ed-0f5319110554 68094-015 HUMAN OTC DRUG Dye Free Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20170113 OTC MONOGRAPH NOT FINAL part343 Precision Dose, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 68094-017_b478fb34-7d5c-430e-b6e1-238fee295227 68094-017 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20171122 ANDA ANDA076003 Precision Dose, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68094-101_59310d75-f5d5-405a-a5b7-a325c762ae7c 68094-101 HUMAN PRESCRIPTION DRUG PHENTOLAMINE MESYLATE PHENTOLAMINE MESYLATE INJECTION INTRAMUSCULAR; INTRAVENOUS 20170715 ANDA ANDA207686 Precision Dose Inc. PHENTOLAMINE MESYLATE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68094-107_5f2e67a7-d105-4208-ad3c-443741367d78 68094-107 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140226 ANDA ANDA091292 Precision Dose Inc. LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 68094-108_bc556980-4841-4a2f-a83a-50bdbfb7826f 68094-108 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SUSPENSION ORAL 20140226 ANDA ANDA091292 Precision Dose Inc. LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 68094-123_1ac3aa8b-af0b-451e-acd0-e9888da93519 68094-123 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine SUSPENSION ORAL 20170913 ANDA ANDA202961 Precision Dose, Inc. OXCARBAZEPINE 300 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68094-171_dba0405a-4bcf-4529-8d23-7287cc05bcec 68094-171 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate SUSPENSION ORAL 20030821 NDA NDA019183 Precision Dose Inc. SUCRALFATE 1 g/10mL Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 68094-193_5d344873-8516-4b29-a6cf-a044be8b7a8f 68094-193 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 20031210 ANDA ANDA070868 Precision Dose Inc. VALPROIC ACID 250 mg/5mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68094-204_70e030b1-5b33-4649-af9f-c8a38f70a164 68094-204 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride SOLUTION ORAL 20030821 ANDA ANDA078312 Precision Dose Inc. RANITIDINE HYDROCHLORIDE 150 mg/10mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68094-214_93723a49-6e52-47f7-9f62-99a661ee70c2 68094-214 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine SUSPENSION ORAL 20030902 ANDA ANDA076729 Precision Dose Inc. CARBAMAZEPINE 200 mg/10mL Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 68094-250_d40da759-a31d-476e-9199-5d8706208f72 68094-250 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20140623 ANDA ANDA075671 Precision Dose Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68094-301_93723a49-6e52-47f7-9f62-99a661ee70c2 68094-301 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine SUSPENSION ORAL 20070227 ANDA ANDA076729 Precision Dose Inc. CARBAMAZEPINE 100 mg/5mL Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 68094-361_b729b5b9-bc41-49c9-b6c7-8fced6dd506f 68094-361 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate SUSPENSION ORAL 20141008 ANDA ANDA075671 Precision Dose Inc. MEGESTROL ACETATE 40 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68094-494_c025931c-2a24-417d-9e75-ec2947ecbe3b 68094-494 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20040413 ANDA ANDA074937 Precision Dose Inc. IBUPROFEN 100 mg/5mL N 20181231 68094-503_c025931c-2a24-417d-9e75-ec2947ecbe3b 68094-503 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060914 ANDA ANDA074937 Precision Dose Inc. IBUPROFEN 200 mg/10mL N 20181231 68094-586_0995fb7d-a6ee-4bc5-a7cd-41ea7e9fa0ec 68094-586 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20140730 OTC MONOGRAPH NOT FINAL part343 Precision Dose Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 68094-587_f6b1e517-3959-476f-8223-944c24a960ed 68094-587 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20140411 OTC MONOGRAPH NOT FINAL part343 Precision Dose Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 68094-588_ffeeb4b8-f32b-43e4-a022-a04f59be86f9 68094-588 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20140423 OTC MONOGRAPH NOT FINAL part343 Precision Dose Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 68094-599_7105726a-aee9-412a-bcb0-d07ead89e896 68094-599 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20051215 ANDA ANDA062512 Precision Dose, Inc. NYSTATIN 500000 [USP'U]/5mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 68094-600_d1d0316f-a312-42eb-bf74-d9c1e1163918 68094-600 HUMAN OTC DRUG Dye Free Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20150826 ANDA ANDA074937 Precision Dose Inc. IBUPROFEN 100 mg/5mL N 20181231 68094-701_5d344873-8516-4b29-a6cf-a044be8b7a8f 68094-701 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid SOLUTION ORAL 20070130 ANDA ANDA070868 Precision Dose Inc. VALPROIC ACID 500 mg/10mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68094-714_8d939454-6e80-43dd-ad53-f63e199214ff 68094-714 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen SOLUTION ORAL 20140227 ANDA ANDA040894 Precision Dose Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 68094-750_ed2bb1ac-4699-4edb-a344-c9cf1f71c49d 68094-750 HUMAN PRESCRIPTION DRUG Diazepam Diazepam SOLUTION ORAL 20120222 ANDA ANDA070928 Precision Dose Inc. DIAZEPAM 5 mg/5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68094-751_e2ab0323-9428-47e7-b426-0b6e64d32ddd 68094-751 HUMAN PRESCRIPTION DRUG Digoxin Digoxin SOLUTION ORAL 20170119 NDA NDA021648 Precision Dose, Inc. DIGOXIN .05 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 68094-752_b4a43784-d0fc-4998-8304-7ddb14dad2ad 68094-752 HUMAN PRESCRIPTION DRUG Digoxin Digoxin SOLUTION ORAL 20120504 NDA NDA021648 Precision Dose Inc. DIGOXIN .05 mg/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 68094-754_6ee6879b-0d38-400f-9ebf-c43320fa7f74 68094-754 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20130816 NDA NDA022195 Precision Dose Inc. MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68094-755_a9f2bbcd-8bfd-4135-8fab-a9f5dd113e1c 68094-755 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20140604 NDA NDA022195 Precision Dose Inc. MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68094-756_48c01593-bf9c-4a66-9349-508a680d7906 68094-756 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 20121023 ANDA ANDA070434 Precision Dose Inc. FUROSEMIDE 40 mg/4mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68094-757_df246892-c00e-4934-b192-3df3ed386833 68094-757 HUMAN PRESCRIPTION DRUG Lithium Lithium SOLUTION ORAL 20121025 NDA NDA018421 Precision Dose Inc. LITHIUM CITRATE 8 meq/5mL Mood Stabilizer [EPC] N 20181231 68094-762_c7abaa98-f8f4-4698-a890-739ad7c88480 68094-762 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL 20150526 ANDA ANDA075873 Precision Dose Inc. MIDAZOLAM HYDROCHLORIDE 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68094-763_c0fae9b8-b61d-481a-bf8e-3c6eec4bd92a 68094-763 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride SOLUTION ORAL 20150227 ANDA ANDA076960 Precision Dose Inc. ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68094-764_ffcd80d5-a281-4d0f-bd78-f38592a0ece4 68094-764 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride SYRUP ORAL 20150526 ANDA ANDA075873 Precision Dose Inc. MIDAZOLAM HYDROCHLORIDE 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68094-801_33be33fc-1b32-4c17-8e8e-0caa003fcb53 68094-801 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20160701 ANDA ANDA204092 Precision Dose, Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68094-852_95493a67-c217-44c6-8346-102358e58c8f 68094-852 HUMAN PRESCRIPTION DRUG Hyrdomorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20140217 ANDA ANDA076723 Precision Dose Inc. HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68094-853_15d827e4-bb81-4a24-adea-bde29b0d32a1 68094-853 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride naltrexone Hydrochloride TABLET, FILM COATED ORAL 20141029 ANDA ANDA075274 Precision Dose Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 68094-867_30c8ac75-d550-44f5-ae0a-b9b91b6d3e98 68094-867 HUMAN PRESCRIPTION DRUG Furosemide Furosemide SOLUTION ORAL 20160128 ANDA ANDA070433 Precision Dose Inc. FUROSEMIDE 40 mg/5mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68105-003_45b81918-52ed-4202-b43f-7521d0d46f84 68105-003 HUMAN OTC DRUG Jurlique Moisturizing Hand Sanitizer Natural Antibacterial ALCOHOL LOTION TOPICAL 20110117 OTC MONOGRAPH NOT FINAL part333E Jurlique International Pty. Ltd. ALCOHOL 613.8 mg/mL E 20171231 68105-004_1027a948-e345-4f76-9c3c-91256e8d9d30 68105-004 HUMAN OTC DRUG Jurlique Purely Sun-Defying Moisturizer with SPF 15 Sunscreen ZINC OXIDE and TITANIUM DIOXIDE CREAM, AUGMENTED TOPICAL 20111101 OTC MONOGRAPH FINAL part352 Jurlique International Pty. Ltd. ZINC OXIDE; TITANIUM DIOXIDE 4.8; 2.1 g/100g; g/100g E 20171231 68105-005_4b7fb903-ee50-4b07-81c6-e0023b652941 68105-005 HUMAN OTC DRUG Jurlique Sun Sunscreen SPF 30 Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide CREAM, AUGMENTED TOPICAL 20130101 OTC MONOGRAPH FINAL part352 Jurlique International Pty. Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 50; 21 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 68105-006_d1410464-efb4-487f-a76a-a3c6abc956a1 68105-006 HUMAN OTC DRUG Jurlique SPF40 High Protection Sunscreen AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part352 Jurlique International AVOBENZONE; OCTINOXATE; OCTOCRYLENE 30; 75; 27.5 mg/mL; mg/mL; mg/mL N 20181231 68113-107_a93cb1c1-283c-45f4-bfa8-c67c62106b73 68113-107 HUMAN OTC DRUG POVIDONE-IODINE Prep Pad POVIDONE-IODINE SWAB TOPICAL 20130211 OTC MONOGRAPH NOT FINAL part333A Carribbean Medical Brokers d.b.a. Specialty Medical Supplies POVIDONE-IODINE .1 g/1 E 20171231 68113-114_5b2eb257-a084-46fc-84db-b58a9a337723 68113-114 HUMAN OTC DRUG Sterile Alcohol Prep Pads Isopropyl Alcohol LIQUID TOPICAL 20120712 OTC MONOGRAPH NOT FINAL part333A Carribbean Medical Brokers d.b.a. Specialty Medical Supplies ISOPROPYL ALCOHOL .8 g/mL E 20171231 68113-520_e2785abe-ca1f-4044-9d7b-68ee4ae40f6e 68113-520 HUMAN OTC DRUG Alcohol Prep ISOPROPYL ALCOHOL SWAB TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part333A CARIBBEAN MEDICAL BROKERS, INC ISOPROPYL ALCOHOL 70 1/1 E 20171231 68113-720_76b5e3c5-c014-47e7-b895-fa37f15ea5ee 68113-720 HUMAN OTC DRUG Sterile Alcohol Prep Pad Sterile Alcohol Prep Pad LIQUID TOPICAL 20110224 OTC MONOGRAPH NOT FINAL part333E Caribbean Medical Brokers ALCOHOL .8 g/mL E 20171231 68113-996_5d7947ab-f60d-499d-84dd-bddd949caf78 68113-996 HUMAN OTC DRUG Alcohol Prep Pad Alcohol Prep Pad LIQUID TOPICAL 20050101 OTC MONOGRAPH NOT FINAL part333E Caribbean Medical Brokers ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 68121-174_6068c895-4855-9246-e053-2a91aa0a6b67 68121-174 HUMAN OTC DRUG Morning Fresh Sodium Fluoride PASTE ORAL 20140514 OTC MONOGRAPH FINAL part355 Patcos Cosmetics (India) Private Limited SODIUM FLUORIDE 2.2 mg/g N 20181231 68134-201_d8bdbe16-4e4a-427e-86d0-830a729ab479 68134-201 HUMAN PRESCRIPTION DRUG Naproxen Naproxen SUSPENSION ORAL 20130625 ANDA ANDA074190 Palmetto Pharmaceuticals NAPROXEN 125 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68135-020_f3f4aecc-993f-4026-9ee5-48b5eed25851 68135-020 HUMAN PRESCRIPTION DRUG NAGLAZYME galsulfase SOLUTION INTRAVENOUS 20050609 BLA BLA125117 BioMarin Pharmaceutical Inc. GALSULFASE 5 mg/5mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC] N 20191231 68135-100_741b058b-d7ee-41e8-b18b-355015b6dbbf 68135-100 HUMAN PRESCRIPTION DRUG VIMIZIM elosulfase alfa INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20140214 BLA BLA125460 BioMarin Pharmaceutical Inc. ELOSULFASE ALFA 5 mg/5mL alpha-Glucosidases [Chemical/Ingredient],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC] N 20191231 68135-300_ab427198-f546-4dfb-99ad-6fbc3019b244 68135-300 HUMAN PRESCRIPTION DRUG Kuvan SAPROPTERIN DIHYDROCHLORIDE TABLET ORAL 20071214 NDA NDA022181 BioMarin Pharmaceutical Inc. SAPROPTERIN DIHYDROCHLORIDE 100 mg/1 Phenylalanine Hydroxylase Activator [EPC],Phenylalanine Hydroxylase Activators [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68135-301_ab427198-f546-4dfb-99ad-6fbc3019b244 68135-301 HUMAN PRESCRIPTION DRUG Kuvan SAPROPTERIN DIHYDROCHLORIDE POWDER, FOR SOLUTION ORAL 20140221 NDA NDA205065 BioMarin Pharmaceutical Inc. SAPROPTERIN DIHYDROCHLORIDE 100 mg/1 Phenylalanine Hydroxylase Activator [EPC],Phenylalanine Hydroxylase Activators [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68135-482_ab427198-f546-4dfb-99ad-6fbc3019b244 68135-482 HUMAN PRESCRIPTION DRUG Kuvan sapropterin dihydrochloride POWDER, FOR SOLUTION ORAL 20150527 NDA NDA205065 BioMarin Pharmaceutical Inc. SAPROPTERIN DIHYDROCHLORIDE 500 mg/1 Phenylalanine Hydroxylase Activator [EPC],Phenylalanine Hydroxylase Activators [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68135-811_beb45644-ec20-4e94-a315-9482294b8995 68135-811 HUMAN PRESCRIPTION DRUG Brineura cerliponase alfa KIT INTRAVENTRICULAR 20170427 BLA BLA761052 BioMarin Pharmaceutical Inc. N 20181231 68151-0012_7e5037b1-4d47-4454-8cde-b93717dbcb54 68151-0012 HUMAN OTC DRUG Calcium carbonate Calcium carbonate TABLET ORAL 19990412 OTC MONOGRAPH FINAL part331 Carilion Materials Management CALCIUM CARBONATE 648 mg/1 N 20181231 68151-0017_f9160ff8-03c7-40a6-9264-ec9b8e818e10 68151-0017 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20020709 ANDA ANDA075616 Carilion Materials Management NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68151-0050_6f8d2952-d458-46c2-8157-b0598b1a6d02 68151-0050 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 19960213 ANDA ANDA074505 Carilion Materials Management CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68151-0062_1d5c2301-f5e1-4e10-a0dc-d779d5fbb628 68151-0062 HUMAN OTC DRUG Diabetic Tussin DM Dextromethorphan hydrobromide and Guaifenesin LIQUID ORAL 19970501 OTC MONOGRAPH FINAL part341 Carilion Materials Management DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 68151-0079_c01a9760-cfb9-4d0d-9cf6-12d9deff463f 68151-0079 HUMAN PRESCRIPTION DRUG Ticlopidine Hydrochloride Ticlopidine Hydrochloride TABLET, FILM COATED ORAL 19990907 ANDA ANDA075149 Carilion Materials Management TICLOPIDINE HYDROCHLORIDE 250 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 68151-0084_82d30146-b669-48d1-b709-a8b38dabfd41 68151-0084 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20111103 ANDA ANDA201566 Carilion Materials Management FLUCYTOSINE 250 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] N 20181231 68151-0087_5ec3735f-d54d-4b35-b2ae-2a3a2a9cd02a 68151-0087 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20071016 ANDA ANDA074225 Carilion Materials Management BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68151-0088_449f81b8-8255-4348-834e-d37d12f2835e 68151-0088 HUMAN PRESCRIPTION DRUG CALCITRIOL CALCITRIOL CAPSULE ORAL 20090826 NDA AUTHORIZED GENERIC NDA018044 Carilion Materials Management CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 68151-0089_f4b1511d-945c-41fa-8fcf-f30e931526b6 68151-0089 HUMAN PRESCRIPTION DRUG Cardene SR nicardipine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19920221 NDA NDA020005 Carilion Materials Management NICARDIPINE HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68151-0092_610893d6-4504-4028-9249-a418c68ba803 68151-0092 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride nicardipine hydrochloride CAPSULE ORAL 19960719 ANDA ANDA074642 Carilion Materials Management NICARDIPINE HYDROCHLORIDE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68151-0093_e3117a7d-fe88-4581-be04-65ca09e18388 68151-0093 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride nicardipine hydrochloride CAPSULE ORAL 19960719 ANDA ANDA074642 Carilion Materials Management NICARDIPINE HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68151-0098_57b24663-e4b4-4314-ad46-3bef15727fa8 68151-0098 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 Carilion Materials Management KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 68151-0116_974b3e52-3710-498b-8d59-d96491d23b9c 68151-0116 HUMAN OTC DRUG Silace Docusate sodium LIQUID ORAL 19901005 OTC MONOGRAPH NOT FINAL part334 Carilion Materials Management DOCUSATE SODIUM 10 mg/mL N 20181231 68151-0136_a17f1a2e-cadd-4e6c-b0d5-111af08f6444 68151-0136 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride CAPSULE, DELAYED RELEASE PELLETS ORAL 19900529 NDA NDA019614 Carilion Materials Management VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68151-0146_90b8c8fc-448e-4ceb-956d-0039e7e43a04 68151-0146 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SOLUTION ORAL 20090313 ANDA ANDA040891 Carilion Materials Management PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68151-0149_fd2e7810-b660-41ab-a6c9-358243d18c37 68151-0149 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET ORAL 20090704 ANDA ANDA078939 Carilion Materials Management ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] N 20181231 68151-0150_1df0a9ba-c97f-415b-bc36-4b129304a39a 68151-0150 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride SYRUP ORAL 19950309 ANDA ANDA087294 Carilion Materials Management HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68151-0155_04cdc6b9-06c5-44ff-84f4-9d7799e047c6 68151-0155 HUMAN PRESCRIPTION DRUG Demeclocycline Hydrochloride Demeclocycline Hydrochloride TABLET ORAL 20100401 ANDA ANDA065425 Carilion Materials Management DEMECLOCYCLINE HYDROCHLORIDE 150 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68151-0158_c000cad8-9732-4c2e-b592-8f044ab27dcd 68151-0158 HUMAN PRESCRIPTION DRUG Mephyton phytonadione TABLET ORAL 20130319 NDA NDA010104 Carilion Materials Management PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 68151-0162_3755be8b-624b-4bc4-958b-505220694dc1 68151-0162 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride Amiloride Hydrochloride TABLET ORAL 19860122 ANDA ANDA070346 Carilion Materials Management AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 68151-0177_de362e03-8097-4721-b116-06007f90a617 68151-0177 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20060627 ANDA ANDA076052 Carilion Materials Management SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68151-0182_27d18085-ce4e-45ef-a46f-58a7fd142a20 68151-0182 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Carilion Materials Management LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68151-0183_05937da8-03c7-4846-b1b8-819861f371f2 68151-0183 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Carilion Materials Management LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68151-0184_d23bd333-a1d5-428b-9b3f-9cb545dac44c 68151-0184 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075718 Carilion Materials Management FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68151-0185_faab6646-d9d0-4835-9b83-d55e34a2520d 68151-0185 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075786 Carilion Materials Management FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68151-0237_efcddc0e-454b-45e3-b78c-1e9f5a2cdb8a 68151-0237 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Carilion Materials Management LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 68151-0238_16085835-5a05-4514-8b4d-ee1ec49833a0 68151-0238 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20090323 ANDA ANDA090097 Carilion Materials Management LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 68151-0245_0dcf84d5-3c52-4be2-b8d3-7d86f73172d3 68151-0245 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20040105 ANDA ANDA076691 Carilion Materials Management LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] N 20181231 68151-0279_94aceca2-4a9e-4203-ba0f-f06978b3e011 68151-0279 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Carilion Materials Management INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68151-0308_9feeedf4-555b-4ace-9319-a1ec39aa2321 68151-0308 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20060804 ANDA ANDA076690 Carilion Materials Management VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68151-0312_75c040b8-d3c3-4df8-adb9-af948f9bc0dd 68151-0312 HUMAN PRESCRIPTION DRUG Dipentum olsalazine sodium CAPSULE, GELATIN COATED ORAL 20150515 NDA NDA019715 Carilion Materials Management OLSALAZINE SODIUM 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 68151-0314_5448244e-249a-4314-8dd9-abbe6534487c 68151-0314 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET ORAL 19930630 NDA AUTHORIZED GENERIC NDA020215 Carilion Materials Management ISOSORBIDE MONONITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68151-0317_155d0146-6095-4132-ad9f-f676496edae0 68151-0317 HUMAN PRESCRIPTION DRUG Risperidone Risperidone SOLUTION ORAL 20160915 ANDA ANDA078909 Carilion Materials Management RISPERIDONE 1 mg/mL Atypical Antipsychotic [EPC] N 20181231 68151-0329_c0ef9358-fc50-4d00-9d93-f21361ed1d05 68151-0329 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Carilion Materials Management PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68151-0487_63079f04-872d-412d-b030-244594867225 68151-0487 HUMAN PRESCRIPTION DRUG Chloroquine Chloroquine Phosphate TABLET, COATED ORAL 19990917 ANDA ANDA083082 Carilion Materials Management CHLOROQUINE PHOSPHATE 500 mg/1 Antimalarial [EPC] N 20181231 68151-0490_a6756f3a-7ee3-444e-adcd-e7ab11e91852 68151-0490 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20100723 ANDA ANDA091004 Carilion Materials Management ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 68151-0511_8248c857-15e9-4504-a417-38196b6e399d 68151-0511 HUMAN PRESCRIPTION DRUG Plaquenil Hydroxychloroquine Sulfate TABLET ORAL 20130628 NDA NDA009768 Carilion Materials Management HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 68151-0523_805836f4-3924-49e7-a677-96a8afcb35a3 68151-0523 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20010131 ANDA ANDA075845 Carilion Materials Management OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-0526_eee23048-2a09-4791-b57c-f61b8458ec92 68151-0526 HUMAN PRESCRIPTION DRUG Norpace disopyramide phosphate CAPSULE, GELATIN COATED ORAL 19820720 NDA NDA018655 Carilion Materials Management DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 68151-0527_ab01df3a-64fa-41c8-a5f3-e71003d5b298 68151-0527 HUMAN PRESCRIPTION DRUG Norpace disopyramide phosphate CAPSULE, GELATIN COATED ORAL 19820720 NDA NDA018655 Carilion Materials Management DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 68151-0528_d38c67e6-e4e4-4a72-9a0c-46519d792758 68151-0528 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 19900930 ANDA ANDA070102 Carilion Materials Management DISOPYRAMIDE PHOSPHATE 150 mg/1 Antiarrhythmic [EPC] N 20181231 68151-0537_51a53a2a-d84c-4251-95d4-aca96fde8980 68151-0537 HUMAN PRESCRIPTION DRUG Acarbose acarbose TABLET ORAL 20110728 ANDA ANDA090912 Carilion Materials Management ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 68151-0561_8de83a42-e3cc-47c4-99ef-74e1b0cc4582 68151-0561 HUMAN PRESCRIPTION DRUG Diclofenac Potassium Diclofenac Potassium TABLET, FILM COATED ORAL 19980811 ANDA ANDA075219 Carilion Materials Management DICLOFENAC POTASSIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-0574_28a6c43a-c01b-4be5-b385-cb8a76da1fa2 68151-0574 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20110613 ANDA ANDA091083 Carilion Materials Management NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-0607_edc24a6c-4754-4695-af73-de2797457ba7 68151-0607 HUMAN PRESCRIPTION DRUG Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE TABLET ORAL 20080507 UNAPPROVED DRUG OTHER Carilion Materials Management PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68151-0609_7907be8a-7b68-4d17-a4b3-14d0ab98ee60 68151-0609 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20080825 ANDA ANDA077419 Carilion Materials Management POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68151-0614_eb9cc48b-4d89-4a5e-a15f-392f13ac3dd2 68151-0614 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20080714 ANDA ANDA040847 Carilion Materials Management GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68151-0618_4f6b4550-c33c-45ef-8b6d-ea950337bf52 68151-0618 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SOLUTION ORAL 19951117 ANDA ANDA074352 Carilion Materials Management LOPERAMIDE HYDROCHLORIDE 1 mg/5mL N 20181231 68151-0623_0b490301-5cb7-4a3a-9d34-f1bb1ec743a7 68151-0623 HUMAN PRESCRIPTION DRUG Guanfacine Guanfacine TABLET ORAL 19951017 ANDA ANDA074145 Carilion Materials Management GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68151-0637_c238a628-ef0f-40c7-9917-ac3b9885f804 68151-0637 HUMAN PRESCRIPTION DRUG fluvoxamine maleate Fluvoxamine maleate TABLET, COATED ORAL 20110809 NDA AUTHORIZED GENERIC NDA021519 Carilion Materials Management FLUVOXAMINE MALEATE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68151-0639_dd6eb08e-888a-4be4-88d1-80c27f18a74f 68151-0639 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20041028 ANDA ANDA076832 Carilion Materials Management LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 68151-0644_2b30ffce-124c-4009-82e6-3340aeab1e51 68151-0644 HUMAN PRESCRIPTION DRUG ELIXOPHYLLIN THEOPHYLLINE ANHYDROUS LIQUID ORAL 20091001 ANDA ANDA085186 Carilion Materials Management THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68151-0648_155578ed-dc71-4e4a-9bbc-24776611b706 68151-0648 HUMAN OTC DRUG Senna Sennosides A and B SYRUP ORAL 20120423 OTC MONOGRAPH NOT FINAL part334 Carilion Materials Management SENNOSIDES A AND B 8.8 mg/5mL N 20181231 68151-0661_2a912c82-4240-4ec9-9d1c-3be4d69dc702 68151-0661 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 19920501 ANDA ANDA073419 Carilion Materials Management ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68151-0667_29fe6915-377d-4310-ad94-bf6144b849bb 68151-0667 HUMAN PRESCRIPTION DRUG Theophylline Anhydrous Theophylline TABLET, EXTENDED RELEASE ORAL 20120202 ANDA ANDA087571 Carilion Materials Management THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68151-0681_da79406e-e2b9-44d8-b987-b9484c895979 68151-0681 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Carilion Materials Management RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68151-0692_3ecddb69-500e-4800-b7ca-ef6bd1aae169 68151-0692 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 19930629 ANDA ANDA072924 Carilion Materials Management VERAPAMIL HYDROCHLORIDE 40 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68151-0693_96cb5219-8aa5-4077-93eb-a45529b27a6c 68151-0693 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140129 ANDA ANDA074587 Carilion Materials Management VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68151-0703_23007611-e51a-4f28-b3e9-66ab545a5ced 68151-0703 HUMAN OTC DRUG Acetaminophen and Diphenhydramine HCl Acetaminophen and Diphenhydramine HCl TABLET ORAL 20101006 OTC MONOGRAPH NOT FINAL part348 Carilion Materials Management ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 68151-0738_44653aa9-6396-4551-b21b-dadf69bb3b58 68151-0738 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20010209 ANDA ANDA075665 Carilion Materials Management ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-0757_942126ae-9a8e-4261-8c1b-f1403873547a 68151-0757 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070611 ANDA ANDA077522 Carilion Materials Management TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68151-0759_1520cec4-e46f-4ad4-b661-aabdbfad1615 68151-0759 HUMAN PRESCRIPTION DRUG Prednisolone Sodium Phosphate Prednisolone Sodium Phosphate SOLUTION ORAL 20050425 ANDA ANDA076913 Carilion Materials Management PREDNISOLONE SODIUM PHOSPHATE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68151-0765_6b01ad0e-72e9-423e-a542-26073a779a80 68151-0765 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20031107 ANDA ANDA076467 Carilion Materials Management GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68151-0820_a78d32c4-e825-4368-9838-7869c4dd89f8 68151-0820 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE SOLUTION ORAL 19861213 ANDA ANDA088703 Carilion Materials Management PREDNISONE 5 mg/mL N 20181231 68151-0821_06d0f87e-9cef-435c-9c3f-ae7293dfb788 68151-0821 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride SOLUTION ORAL 19870515 ANDA ANDA070979 Carilion Materials Management PROPRANOLOL HYDROCHLORIDE 20 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-0848_5c228bb0-2237-47d4-93bd-736ca3357972 68151-0848 HUMAN PRESCRIPTION DRUG Diflunisal Diflunisal TABLET, FILM COATED ORAL 19921101 ANDA ANDA073673 Carilion Materials Management DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-0849_6d9182cf-6e6b-4859-a4a5-7d5f4f6d16bc 68151-0849 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20151221 ANDA ANDA090066 Carilion Materials Management DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-0910_01f8a4c6-b19d-49c4-83db-bb6a0f60fef6 68151-0910 HUMAN PRESCRIPTION DRUG AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE SOLUTION ORAL 19950717 ANDA ANDA074509 Carilion Materials Management AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 68151-0984_4ea002b4-0da9-40c9-b1cd-36c29b156d5f 68151-0984 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20030701 ANDA ANDA076411 Carilion Materials Management METHENAMINE HIPPURATE 1 g/1 N 20181231 68151-0985_2e50b6c2-4b4e-4fa5-b916-c93b5760483b 68151-0985 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE, COATED ORAL 20010701 ANDA ANDA065028 Carilion Materials Management RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 68151-0995_63888c73-19cb-4277-86a8-681ae4ea024c 68151-0995 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 ANDA ANDA077955 Carilion Materials Management AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68151-1008_6241ec88-9f31-4198-ad42-d850eb9fd932 68151-1008 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine hydrochloride SOLUTION ORAL 20080724 ANDA ANDA078398 Carilion Materials Management CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 68151-1013_a08fd783-9a73-402b-8bd8-b45a68addce0 68151-1013 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Carilion Materials Management ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68151-1019_c536d481-cc6d-4d3e-8d1d-accbec36c4dc 68151-1019 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 19760827 ANDA ANDA084349 Carilion Materials Management PHENYTOIN SODIUM 30 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 68151-1020_b0603993-03f4-4b9c-b86c-abe5913a7a87 68151-1020 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA AUTHORIZED GENERIC NDA019885 Carilion Materials Management QUINAPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68151-1021_24da567a-66d8-49c0-91b6-f9258eaa2f11 68151-1021 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA AUTHORIZED GENERIC NDA019885 Carilion Materials Management QUINAPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68151-1022_0e0c7ebe-bdf1-4e38-8ab0-7c25b1dbd032 68151-1022 HUMAN PRESCRIPTION DRUG Quinapril Hydrochloride quinapril hydrochloride TABLET, FILM COATED ORAL 19911119 NDA AUTHORIZED GENERIC NDA019885 Carilion Materials Management QUINAPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68151-1028_ef5b0308-facf-4b40-ad45-fa9b7ac2829f 68151-1028 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20050406 ANDA ANDA075360 Carilion Materials Management GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68151-1030_db199579-f959-4808-806e-d011080ca637 68151-1030 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20041004 ANDA ANDA075350 Carilion Materials Management GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68151-1161_04243592-1a86-4b99-ac93-eb16974bc7d1 68151-1161 HUMAN PRESCRIPTION DRUG dicyclomine hydrochloride dicyclomine hydrochloride SOLUTION ORAL 20050623 ANDA ANDA040169 Carilion Materials Management DICYCLOMINE HYDROCHLORIDE 10 mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68151-1164_eb8df045-1d10-4de4-bf33-d29e36400eca 68151-1164 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078597 Carilion Materials Management DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68151-1170_8eb5a5b5-ec11-4db7-b4ff-3f1028e0e442 68151-1170 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 Carilion Materials Management ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68151-1174_a613594f-d5fe-4e88-9049-2b21824a061d 68151-1174 HUMAN PRESCRIPTION DRUG ERY-TAB Erythromycin TABLET, DELAYED RELEASE ORAL 20110418 ANDA ANDA062298 Carilion Materials Management ERYTHROMYCIN 333 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68151-1176_0376a6f1-ac73-4523-8c6d-67d52b63a507 68151-1176 HUMAN PRESCRIPTION DRUG Erythromycin Base Erythromycin TABLET, FILM COATED ORAL 20110906 ANDA ANDA061621 Carilion Materials Management ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68151-1281_d708db44-7982-4bf1-add5-c854a5cfc71b 68151-1281 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20060127 ANDA ANDA077122 Carilion Materials Management DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 68151-1294_d94dd02c-a6c6-4f35-b663-c9bd335fd478 68151-1294 HUMAN PRESCRIPTION DRUG Indapamide Indapamide TABLET, FILM COATED ORAL 19970326 ANDA ANDA074461 Carilion Materials Management INDAPAMIDE 1.25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 68151-1305_740abe91-3788-4bef-9cba-9a3d8d7ec7f8 68151-1305 HUMAN PRESCRIPTION DRUG Bromocriptine mesylate Bromocriptine mesylate TABLET ORAL 20140401 ANDA ANDA077646 Carilion Materials Management BROMOCRIPTINE MESYLATE 2.5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 68151-1313_db3cc173-afb3-4b23-9490-c803d52077ee 68151-1313 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20030827 ANDA ANDA040511 Carilion Materials Management BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20181231 68151-1320_46478d1b-5dea-4315-9042-8201ed2b57fd 68151-1320 HUMAN PRESCRIPTION DRUG Pindolol pindolol TABLET ORAL 19920903 ANDA ANDA074019 Carilion Materials Management PINDOLOL 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-1326_3a755dcc-08e8-4965-8290-d3d4187d50f7 68151-1326 HUMAN PRESCRIPTION DRUG Fluvastatin Sodium fluvastatin CAPSULE ORAL 20130319 ANDA ANDA090595 Carilion Materials Management FLUVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68151-1327_d277a6e5-f60f-4265-998d-6c662617d7b9 68151-1327 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine TABLET ORAL 20110101 ANDA ANDA077533 Carilion Materials Management TERBINAFINE HYDROCHLORIDE 250 1/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 68151-1333_3d8f2a9d-e940-469a-8bda-5f7a1dc85689 68151-1333 HUMAN PRESCRIPTION DRUG Isradipine Isradipine CAPSULE ORAL 20060105 ANDA ANDA077317 Carilion Materials Management ISRADIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68151-1334_935629c8-093f-44fc-a629-b1f920153213 68151-1334 HUMAN PRESCRIPTION DRUG Fluvastatin Sodium fluvastatin CAPSULE ORAL 20130319 ANDA ANDA090595 Carilion Materials Management FLUVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68151-1363_fbccf5a8-ac76-4a0c-862e-de13c826e454 68151-1363 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Carilion Materials Management AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68151-1364_ede8777a-07eb-4a23-a7a5-6c7e410b4357 68151-1364 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100205 ANDA ANDA078466 Carilion Materials Management AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68151-1365_21e57f79-f56c-490f-a0b7-40799e7e50f8 68151-1365 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride amlodipine besylate and benazepril hydrochloride CAPSULE ORAL 19950303 NDA AUTHORIZED GENERIC NDA020364 Carilion Materials Management AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68151-1393_7fe01ca0-e1e8-4402-9e7e-60c263cbc610 68151-1393 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20160129 ANDA ANDA090430 Carilion Materials Management THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68151-1418_37641f76-c88d-4779-989a-cda49959450c 68151-1418 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060330 ANDA ANDA076813 Carilion Materials Management ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68151-1420_cc752fd3-a51c-4770-bc08-2421ba4efaab 68151-1420 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 19981030 ANDA ANDA075155 Carilion Materials Management ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68151-1437_2e661515-63eb-4335-a96a-80fc4d66ae96 68151-1437 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 Carilion Materials Management BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 68151-1438_85855c01-3ce2-435b-92bd-7d6347682c8f 68151-1438 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 Carilion Materials Management BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 68151-1442_c936246c-a6ee-430b-8663-2fdf730cee2b 68151-1442 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Carilion Materials Management METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68151-1452_691bef2a-1d09-4e15-bc80-e403e6649584 68151-1452 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 Carilion Materials Management FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 68151-1457_74b059f2-b35e-4f17-90c1-473e59f1a702 68151-1457 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 Carilion Materials Management DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68151-1463_41f638ce-2faf-49d5-8d5e-c00bdba1ffe2 68151-1463 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET ORAL 20000215 ANDA ANDA040327 Carilion Materials Management ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68151-1464_7f7c44bd-f26b-487b-bde1-3496c011b1ed 68151-1464 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20030114 ANDA ANDA076278 Carilion Materials Management FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 68151-1471_827347b0-4c00-49f2-878f-ca5f72697e05 68151-1471 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL; SUBLINGUAL 20090921 UNAPPROVED DRUG OTHER Carilion Materials Management HYOSCYAMINE SULFATE .125 mg/1 N 20181231 68151-1472_2517e55f-cae7-4b4a-8565-7f3569a66ca7 68151-1472 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET, FILM COATED ORAL 20030508 ANDA ANDA076204 Carilion Materials Management MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68151-1473_2517e55f-cae7-4b4a-8565-7f3569a66ca7 68151-1473 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET, FILM COATED ORAL 20030508 ANDA ANDA076204 Carilion Materials Management MOEXIPRIL HYDROCHLORIDE 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68151-1480_2ea63016-53e3-4a80-8668-fb36550906ea 68151-1480 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Carilion Materials Management DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 68151-1487_23972e7f-2313-4524-b554-b930e51fed92 68151-1487 HUMAN PRESCRIPTION DRUG Nystatin Nystatin TABLET, FILM COATED ORAL 19900930 ANDA ANDA062506 Carilion Materials Management NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 68151-1494_fbaaeae0-0b49-4982-bb6d-d9ca44a8f24a 68151-1494 HUMAN PRESCRIPTION DRUG Dyrenium Triamterene CAPSULE ORAL 19991001 NDA NDA013174 Carilion Materials Management TRIAMTERENE 50 mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] N 20181231 68151-1497_75dc9419-1177-4afd-bbc1-f168cf6fa25e 68151-1497 HUMAN PRESCRIPTION DRUG Cimetidine cimetidine TABLET, FILM COATED ORAL 19940517 ANDA ANDA074246 Carilion Materials Management CIMETIDINE 200 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68151-1520_cbece5e5-72b3-433f-84ae-03013ce93454 68151-1520 HUMAN PRESCRIPTION DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL 20050301 ANDA ANDA076856 Carilion Materials Management DANTROLENE SODIUM 25 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 68151-1521_ba1caadc-97b9-4353-b728-7a5cb9ecbe3d 68151-1521 HUMAN PRESCRIPTION DRUG Etidronate Disodium etidronate disodium TABLET ORAL 20080102 ANDA ANDA075800 Carilion Materials Management ETIDRONATE DISODIUM 200 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 68151-1584_ba18404b-1d09-480c-b825-373aa9e2e674 68151-1584 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SOLUTION ORAL 20060426 ANDA ANDA040643 Carilion Materials Management PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68151-1602_cdf01423-d033-452a-a862-61ae229ceac3 68151-1602 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Carilion Materials Management DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 68151-1603_f84faf86-75eb-4204-a801-da2a27177ac1 68151-1603 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Carilion Materials Management DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 68151-1610_4950d718-dff7-46b2-acdd-779257fc6570 68151-1610 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Carilion Materials Management RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68151-1658_42257f1f-6ff7-44d0-ba85-b2e206241d63 68151-1658 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA078295 Carilion Materials Management SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68151-1668_f32643d3-4878-4b78-88c2-1d7334939ed7 68151-1668 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride SOLUTION ORAL 20061226 ANDA ANDA076960 Carilion Materials Management ONDANSETRON HYDROCHLORIDE 4 mg/5mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68151-1712_37dba1f7-1117-4a6e-afe5-e8684883ae2c 68151-1712 HUMAN OTC DRUG Dimenhydrinate Dimenhydrinate TABLET ORAL 20040301 OTC MONOGRAPH FINAL part336 Carilion Materials Management DIMENHYDRINATE 50 mg/1 N 20181231 68151-1728_20f392a7-158d-4507-b054-c309642a4bc9 68151-1728 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride SYRUP ORAL 20060710 ANDA ANDA040668 Carilion Materials Management CYPROHEPTADINE HYDROCHLORIDE 2 mg/5mL N 20181231 68151-1733_f68a2ea6-e62f-4a7b-8acb-64ebb0b89e37 68151-1733 HUMAN PRESCRIPTION DRUG INDOMETHACIN Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20090306 ANDA ANDA079175 Carilion Materials Management INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-1738_91720d96-0262-4f70-b731-c42f604f0fbb 68151-1738 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20040129 UNAPPROVED DRUG OTHER Carilion Materials Management NITROGLYCERIN 9 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68151-1741_acbea898-cfd1-420c-9a0c-b8a33d642276 68151-1741 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19930701 ANDA ANDA072801 Carilion Materials Management METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 68151-1742_1fec3fc2-57a0-4ded-be7f-d19c7a3a6412 68151-1742 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20031124 ANDA ANDA074151 Carilion Materials Management CIMETIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68151-1744_7adefcf6-f855-43f1-a624-f351a49978bb 68151-1744 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 Carilion Materials Management BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68151-1840_81a67005-eb73-4722-8cfb-96b92d907fbf 68151-1840 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20140101 ANDA ANDA090617 Carilion Materials Management METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-1923_e495fb85-bf37-4c6f-a9c9-31fd73dbe373 68151-1923 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER Carilion Materials Management SALSALATE 500 mg/1 N 20181231 68151-1924_b6912c9b-480f-4b3a-ba7c-6d289a9bade4 68151-1924 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20100924 UNAPPROVED DRUG OTHER Carilion Materials Management SALSALATE 750 mg/1 N 20181231 68151-1928_429325f6-6635-4358-b4c6-640188f0ef16 68151-1928 HUMAN PRESCRIPTION DRUG RENO CAPS RENO CAPS CAPSULE ORAL 20081130 UNAPPROVED DRUG OTHER Carilion Materials Management ASCORBIC ACID; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE; FOLIC ACID; BIOTIN; PANTOTHENIC ACID; CYANOCOBALAMIN 100; 1.5; 1.7; 20; 10; 1; 150; 5; 6 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 68151-1929_ccd6bad9-aa0c-4aad-bd90-557bebbd205c 68151-1929 HUMAN OTC DRUG ORGAN-I NR guaifenesin TABLET ORAL 20020701 OTC MONOGRAPH FINAL part341 Carilion Materials Management GUAIFENESIN 200 mg/1 N 20181231 68151-1977_a156e12b-8b55-4195-8c9c-0613a379ea06 68151-1977 HUMAN PRESCRIPTION DRUG Zafirlukast Zafirlukast TABLET, FILM COATED ORAL 20101118 ANDA ANDA090372 Carilion Materials Management ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68151-1980_da484cd8-2c3f-4650-a3cf-70c91eefe9e5 68151-1980 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19830210 ANDA ANDA087946 Carilion Materials Management ISOSORBIDE DINITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68151-1991_35843ff3-e830-43ff-a9c0-ad7abdcbda15 68151-1991 HUMAN PRESCRIPTION DRUG Quinidine Sulfate Quinidine Sulfate TABLET ORAL 19761124 ANDA ANDA083288 Carilion Materials Management QUINIDINE SULFATE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 68151-1992_5ef9ac99-fd51-4f37-8c2e-1875a1c0a52f 68151-1992 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20110823 UNAPPROVED DRUG OTHER Carilion Materials Management PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 68151-1993_38db7765-dbeb-463a-a064-ece0c613780f 68151-1993 HUMAN PRESCRIPTION DRUG Probenecid probenecid TABLET, FILM COATED ORAL 19760113 ANDA ANDA084211 Carilion Materials Management PROBENECID 500 mg/1 N 20181231 68151-2007_0d791e94-6623-475d-a6a5-51bd00232964 68151-2007 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 Carilion Materials Management METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68151-2010_dbf1feea-e5cd-498d-be46-f3f5c35e9ac9 68151-2010 HUMAN PRESCRIPTION DRUG Trimethoprim Trimethoprim TABLET ORAL 20100404 ANDA ANDA070049 Carilion Materials Management TRIMETHOPRIM 100 mg/1 Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68151-2013_56a92945-fac8-44ca-b3a1-5262cf5c0409 68151-2013 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19860513 ANDA ANDA070175 Carilion Materials Management PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-2014_42ce1d9a-ace6-4a8d-92da-3200ad1b5520 68151-2014 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070218 Carilion Materials Management PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-2016_ec4e92a5-ffff-4ed6-881f-dd0a9cfa26cc 68151-2016 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Carilion Materials Management PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-2022_6e0d639c-de59-4679-9002-0567aa80a93d 68151-2022 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 Carilion Materials Management DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68151-2030_009ac128-3e2c-4c75-b6d4-f8e5c8f4b186 68151-2030 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 19890228 ANDA ANDA072575 Carilion Materials Management PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68151-2031_66cce4de-c6bc-42f8-9fdf-6c9814f58152 68151-2031 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 19951214 ANDA ANDA072709 Carilion Materials Management MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68151-2032_d752129d-78a3-4d36-855e-41b42a7c721e 68151-2032 HUMAN PRESCRIPTION DRUG Minoxidil Minoxidil TABLET ORAL 20091026 ANDA ANDA071345 Carilion Materials Management MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68151-2103_fc97c5f7-872a-4268-afdb-001dd07762c9 68151-2103 HUMAN PRESCRIPTION DRUG Rimantadine Hydrochloride Rimantadine Hydrochloride TABLET, FILM COATED ORAL 20050401 ANDA ANDA076132 Carilion Materials Management RIMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 68151-2111_1891456c-0de0-4e66-84f0-ae86313026f2 68151-2111 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Carilion Materials Management DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 68151-2112_02d2677e-4078-4493-96c0-b0c795757896 68151-2112 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Carilion Materials Management DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 68151-2113_9789e1e1-3c69-454e-8309-59ffecfe60d1 68151-2113 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Carilion Materials Management DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 68151-2114_67cef337-aa31-4720-99a7-b40307e7ce53 68151-2114 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20090925 NDA AUTHORIZED GENERIC NDA020401 Carilion Materials Management DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 68151-2193_01e77301-afcb-421b-b2c3-58ad1fbef7b8 68151-2193 HUMAN PRESCRIPTION DRUG K Phos Original Potassium Phosphate, Monobasic TABLET, SOLUBLE ORAL 19770329 UNAPPROVED DRUG OTHER Carilion Materials Management POTASSIUM PHOSPHATE, MONOBASIC 500 mg/1 N 20181231 68151-2195_93b368dc-b63f-40f5-84a5-da53f63d4554 68151-2195 HUMAN PRESCRIPTION DRUG Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate TABLET ORAL 20120628 UNAPPROVED DRUG OTHER Carilion Materials Management SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 852; 155; 130 mg/1; mg/1; mg/1 N 20181231 68151-2262_c6f5dc40-eb5d-4885-a97a-09bf27a7871c 68151-2262 HUMAN OTC DRUG Childrens Chewable Mapap Acetaminophen TABLET, CHEWABLE ORAL 20110504 OTC MONOGRAPH NOT FINAL part343 Carilion Materials Management ACETAMINOPHEN 80 mg/1 N 20181231 68151-2265_313d0ce5-dd49-4540-8fdf-561d57b15a18 68151-2265 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride CAPSULE ORAL 19991103 ANDA ANDA040319 Carilion Materials Management DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68151-2269_b0f9b7ea-bac2-427d-92fa-4ccf1b149332 68151-2269 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20070330 ANDA ANDA040646 Carilion Materials Management HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68151-2298_79371e5b-3968-4c5d-9ef7-c78e92f64080 68151-2298 HUMAN PRESCRIPTION DRUG Danazol Danazol CAPSULE ORAL 20050928 ANDA ANDA077246 Carilion Materials Management DANAZOL 200 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 68151-2299_e2eccf74-1ad0-48cb-a2f5-055830d1e81f 68151-2299 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 19911230 ANDA ANDA063065 Carilion Materials Management MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68151-2346_b1b8b509-fc4c-4dae-be09-4a5b0f16b208 68151-2346 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 Carilion Materials Management TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68151-2347_bd6eb1b5-511e-45e0-984b-9b93233dbf2a 68151-2347 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 19950605 ANDA ANDA074377 Carilion Materials Management MEXILETINE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC] N 20181231 68151-2456_0381b7d6-b261-4c91-9399-bb31be8aa41d 68151-2456 HUMAN OTC DRUG Clemastine Fumarate Clemastine Fumarate TABLET ORAL 19931031 ANDA ANDA073458 Carilion Materials Management CLEMASTINE FUMARATE 1.34 mg/1 N 20181231 68151-2465_ec2ea673-0d64-4f1b-8319-9b6d9f407264 68151-2465 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20100927 ANDA ANDA089742 Carilion Materials Management FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68151-2471_3c350c89-751d-4003-a77a-3cfc115fdf67 68151-2471 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Carilion Materials Management ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 68151-2472_5d292f65-f875-4872-b755-e07da7e84df4 68151-2472 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086066 Carilion Materials Management ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68151-2475_56836c7b-981f-46e1-ba5c-8d0016a256c5 68151-2475 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 19781201 ANDA ANDA086067 Carilion Materials Management ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68151-2476_7591f5af-a836-4a69-af41-8f0f8869d67f 68151-2476 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 19830210 ANDA ANDA087946 Carilion Materials Management ISOSORBIDE DINITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68151-2478_69914db1-4541-43e6-860d-5db847aad97e 68151-2478 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110803 ANDA ANDA084112 Carilion Materials Management CHLORPROMAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68151-2480_c42d9de3-b66a-4646-a1aa-78c9b7c27d78 68151-2480 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20110808 ANDA ANDA083386 Carilion Materials Management CHLORPROMAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68151-2481_000e0356-cc97-4c3c-a0f7-57dcf0c52e30 68151-2481 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19950928 ANDA ANDA074376 Carilion Materials Management DICLOFENAC SODIUM 25 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-2482_986b6865-dfd4-4982-853f-80be12651b20 68151-2482 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 19880524 ANDA ANDA072099 Carilion Materials Management DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68151-2486_7f48aaa3-111d-442c-9470-62fbd019daf1 68151-2486 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 19870623 ANDA ANDA071093 Carilion Materials Management THIOTHIXENE 5 mg/1 Typical Antipsychotic [EPC] N 20181231 68151-2500_19269587-a4ad-4721-81b8-db2c3f89602a 68151-2500 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20090923 NDA AUTHORIZED GENERIC NDA012750 Carilion Materials Management CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] N 20181231 68151-2502_8a839e5c-cbbf-42bd-bd92-cb4fcbceb148 68151-2502 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20040129 UNAPPROVED DRUG OTHER Carilion Materials Management NITROGLYCERIN 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68151-2503_850e4cfc-b38b-47d3-ad77-be560954be75 68151-2503 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20040129 UNAPPROVED DRUG OTHER Carilion Materials Management NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68151-2506_cd5d2717-555a-4b9e-9231-20bf67f17337 68151-2506 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20100615 ANDA ANDA040644 Carilion Materials Management CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 E 20171231 68151-2510_3974c186-e804-431d-814e-fea7ef9d2ecf 68151-2510 HUMAN PRESCRIPTION DRUG ISOSORBIDE DINITRATE ISOSORBIDE DINITRATE TABLET, EXTENDED RELEASE ORAL 20090922 ANDA ANDA040009 Carilion Materials Management ISOSORBIDE DINITRATE 40 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68151-2584_18b916c5-b24f-4855-96f3-881e43be87c5 68151-2584 HUMAN OTC DRUG Zantac 75 ranitidine TABLET, COATED ORAL 20061221 NDA NDA020520 Carilion Materials Management RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 68151-2591_92e289f7-a67b-410e-af9a-7368acd6a3df 68151-2591 HUMAN OTC DRUG Good Neighbor Pharmacy acid reducer Famotidine TABLET ORAL 20091007 ANDA ANDA075400 Carilion Materials Management FAMOTIDINE 10 mg/1 N 20181231 68151-2609_b8532ccd-05a2-4f1a-8664-7d801fedf5c1 68151-2609 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 19980729 ANDA ANDA075227 Carilion Materials Management NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-2640_70ce3a8c-7cbd-4c07-bb81-d77498883fe4 68151-2640 HUMAN PRESCRIPTION DRUG PRENATAL PLUS VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE TABLET, FILM COATED ORAL 20091202 UNAPPROVED DRUG OTHER Carilion Materials Management VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE 3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 68151-2649_1845c27d-1a9d-4204-93dd-391335674724 68151-2649 HUMAN PRESCRIPTION DRUG SELEGILINE HYDROCHLORIDE SELEGILINE HYDROCHLORIDE CAPSULE ORAL 20061104 ANDA ANDA075352 Carilion Materials Management SELEGILINE HYDROCHLORIDE 5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA],Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA] N 20181231 68151-2693_793cbb6c-f958-4b97-b804-fe2817ab7142 68151-2693 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20160304 ANDA ANDA086841 Carilion Materials Management DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 68151-2694_d132ab2a-1616-4984-b277-e685a5fc0e1f 68151-2694 HUMAN PRESCRIPTION DRUG Disulfiram Disulfiram TABLET ORAL 20110401 ANDA ANDA091619 Carilion Materials Management DISULFIRAM 250 mg/1 Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC] N 20181231 68151-2696_e7b14b95-3307-4bfd-b6d9-fca3e31db705 68151-2696 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071525 Carilion Materials Management TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68151-2697_016ba14b-397a-48c4-9fc1-e410242fdde6 68151-2697 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20100604 ANDA ANDA040682 Carilion Materials Management BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68151-2701_3075af2e-9a1c-47a6-b8d2-5c41470c2a68 68151-2701 HUMAN PRESCRIPTION DRUG Quinidine Gluconate Quinidine Gluconate TABLET, EXTENDED RELEASE ORAL 19870210 ANDA ANDA089338 Carilion Materials Management QUINIDINE GLUCONATE 324 mg/1 Antiarrhythmic [EPC],Cytochrome P450 2D6 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 68151-2702_da2e6766-75cb-4904-b4cf-72c42b0f9e84 68151-2702 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20031107 ANDA ANDA075563 Carilion Materials Management SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 68151-2713_c723f7b1-bbfb-472c-a971-a7a81e621808 68151-2713 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075273 Carilion Materials Management KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68151-2718_2a484ede-3eb9-4509-af3d-288228c5738b 68151-2718 HUMAN PRESCRIPTION DRUG itraconazole ITRACONAZOLE CAPSULE ORAL 20050201 NDA NDA020083 Carilion Materials Management ITRACONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68151-2749_36ef72d5-14b1-4eae-802e-4dd749930e0f 68151-2749 HUMAN OTC DRUG Bisacodyl Enteric Coated Bisacodyl TABLET, COATED ORAL 20081024 OTC MONOGRAPH NOT FINAL part334 Carilion Materials Management BISACODYL 5 mg/1 N 20181231 68151-2757_2734146a-618b-4e55-94ce-02a229cdc87d 68151-2757 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19730112 ANDA ANDA083177 Carilion Materials Management HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68151-2760_54c60f17-f2bd-4050-9c5b-f117d937e128 68151-2760 HUMAN PRESCRIPTION DRUG Chlorthalidone Chlorthalidone TABLET ORAL 20160212 ANDA ANDA089286 Carilion Materials Management CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20191231 68151-2768_080d3af1-eb4a-4c23-bcb5-b30c26750861 68151-2768 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 19831021 ANDA ANDA088292 Carilion Materials Management IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68151-2775_d0aab641-b919-4ccc-809c-19885e535cbc 68151-2775 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20131215 ANDA ANDA200958 Carilion Materials Management METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68151-2776_104fd1b1-ea21-4a75-a48e-6ae9c29f2e61 68151-2776 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET, FILM COATED ORAL 20070103 ANDA ANDA040353 Carilion Materials Management SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68151-2780_a32bddf1-6bd6-43ee-a3c7-0eb090a64963 68151-2780 HUMAN PRESCRIPTION DRUG Ergoloid Mesylates Dihydroergocornine Mesylate, Dihydroergocristine Mesylate, Dihydro-.alpha.-ergocryptine mesylate, and Dihydro-.beta.-ergocryptine mesylate TABLET ORAL 19911031 ANDA ANDA081113 Carilion Materials Management DIHYDROERGOCORNINE MESYLATE; DIHYDROERGOCRISTINE MESYLATE; DIHYDRO-.ALPHA.-ERGOCRYPTINE MESYLATE; DIHYDRO-.BETA.-ERGOCRYPTINE MESYLATE .333; .333; .222; .111 mg/1; mg/1; mg/1; mg/1 N 20181231 68151-2781_2734146a-618b-4e55-94ce-02a229cdc87d 68151-2781 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19800107 ANDA ANDA083177 Carilion Materials Management HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68151-2782_76496d76-9d7a-4f3c-8915-94cd77bb2cb7 68151-2782 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 19871101 ANDA ANDA084363 Carilion Materials Management TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 68151-2791_29a33fb6-f519-4c20-8dc4-c5286f79fbd2 68151-2791 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20120724 ANDA ANDA070084 Carilion Materials Management METHYLDOPA 250 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68151-2825_e7b14b95-3307-4bfd-b6d9-fca3e31db705 68151-2825 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Carilion Materials Management TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 68151-2857_111dc0b3-146b-4245-9925-64a68dc4e485 68151-2857 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride Prazosin Hydrochloride CAPSULE ORAL 20070222 ANDA ANDA071995 Carilion Materials Management PRAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68151-2870_81bf021b-a6f9-4a01-a725-2b1c441024a6 68151-2870 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine CAPSULE ORAL 20090811 ANDA ANDA072781 Carilion Materials Management NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68151-2871_b3d696fb-eb14-4e42-acb8-1e897397aeda 68151-2871 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071795 Carilion Materials Management SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-2872_b383bc08-6a0a-43f8-b7ea-33c9b936cfcf 68151-2872 HUMAN PRESCRIPTION DRUG Sulindac Sulindac TABLET ORAL 19900403 ANDA ANDA071795 Carilion Materials Management SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-2875_c88b8fa5-f602-43ca-8bb8-5d7fd7ac3712 68151-2875 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 19880615 ANDA ANDA072204 Carilion Materials Management LOXAPINE SUCCINATE 5 mg/1 N 20181231 68151-2886_acc952cc-47b3-4a04-87bc-e3393c979e3a 68151-2886 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 19951222 ANDA ANDA074185 Carilion Materials Management DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68151-2887_ed095ba4-6dc3-4f0b-97c1-ad13a0ccac67 68151-2887 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET ORAL 20110516 ANDA ANDA090324 Carilion Materials Management CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 68151-2889_a86e62ab-acf4-4d9f-88a8-3f5c6ac61761 68151-2889 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Carilion Materials Management ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-2890_fd3b499b-9feb-42fa-b22e-dcb176721d55 68151-2890 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine Hydrochloride SOLUTION ORAL 20101210 ANDA ANDA091288 Carilion Materials Management RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68151-2893_980150be-93ed-4319-ab1f-9975fcbca93a 68151-2893 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110101 ANDA ANDA077836 Carilion Materials Management GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 68151-2894_c326fe16-3a9d-4ea7-bcc5-9050da71d9ee 68151-2894 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Carilion Materials Management NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-2895_9bb53d9d-5053-40ae-8e33-8bc6638180d9 68151-2895 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Carilion Materials Management NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-2896_5d2c8e1b-b2d9-495a-91b8-4d4244ca4033 68151-2896 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Carilion Materials Management METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-2898_0c926b35-0fc4-4e5a-a454-d887955b05ef 68151-2898 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950406 ANDA ANDA074132 Carilion Materials Management NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68151-2899_7f35c1e2-17b5-4f28-b5f0-ef0d9e4aae5f 68151-2899 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20040202 ANDA ANDA074151 Carilion Materials Management CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68151-2904_6f9b5e51-5248-4375-8f87-7361ac60a675 68151-2904 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH NOT FINAL part343 Carilion Materials Management ASPIRIN 81 mg/1 N 20191231 68151-2908_323237b3-34cc-4bbe-ac79-3f4e46d96a35 68151-2908 HUMAN OTC DRUG Banophen Diphenhydramine HCl TABLET ORAL 19900302 OTC MONOGRAPH FINAL part341 Carilion Materials Management DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68151-2919_1047216a-4f95-4ebf-9d52-63566a5da062 68151-2919 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20100710 NDA NDA018851 Carilion Materials Management INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-2939_8f14f89c-25a2-406e-8b85-72dfd0763dfa 68151-2939 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20041019 ANDA ANDA076698 Carilion Materials Management METOLAZONE 10 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 68151-2942_8f14f89c-25a2-406e-8b85-72dfd0763dfa 68151-2942 HUMAN PRESCRIPTION DRUG Metolazone metolazone TABLET ORAL 20041019 ANDA ANDA076698 Carilion Materials Management METOLAZONE 5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 68151-2943_49ccd855-4a67-48b3-951e-659a5891b718 68151-2943 HUMAN PRESCRIPTION DRUG Zaroxolyn metolazone TABLET ORAL 19731127 NDA NDA017386 Carilion Materials Management METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 68151-2946_b0a54885-add7-4d27-b60d-86d8106aae75 68151-2946 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Carilion Materials Management TORSEMIDE 5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68151-2948_aebffef1-a329-4610-905c-5f8e25c84501 68151-2948 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Carilion Materials Management TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68151-2949_1406aef6-e37c-4a86-bb7c-868643828262 68151-2949 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20110101 ANDA ANDA079234 Carilion Materials Management TORSEMIDE 100 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68151-2958_59e8ac60-c215-4deb-92ff-d531f333cbb1 68151-2958 HUMAN PRESCRIPTION DRUG MIDODRINE HYDROCHLORIDE MIDODRINE HYDROCHLORIDE TABLET ORAL 20040527 ANDA ANDA076449 Carilion Materials Management MIDODRINE HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 68151-2959_691914ba-6279-4b7c-9908-e258330fdb5b 68151-2959 HUMAN PRESCRIPTION DRUG Anagrelide Hydrochloride Anagrelide Hydrochloride CAPSULE ORAL 20050418 ANDA ANDA076468 Carilion Materials Management ANAGRELIDE HYDROCHLORIDE .5 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 68151-2985_1261cde0-8b8f-4c5f-a9d4-3c082196abcd 68151-2985 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 19950605 ANDA ANDA074377 Carilion Materials Management MEXILETINE HYDROCHLORIDE 150 mg/1 Antiarrhythmic [EPC] N 20181231 68151-2986_3a464dbd-3b36-467f-a22a-ba9617189459 68151-2986 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 19950605 ANDA ANDA074377 Carilion Materials Management MEXILETINE HYDROCHLORIDE 250 mg/1 Antiarrhythmic [EPC] N 20181231 68151-2987_cf8b8ae8-c813-4c3d-9360-f908016c89f4 68151-2987 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 19871231 NDA AUTHORIZED GENERIC NDA019594 Carilion Materials Management URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 68151-2991_7b27b7ac-4a47-40f2-b0ea-6885590b97bb 68151-2991 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride CAPSULE ORAL 19870218 ANDA ANDA071293 Carilion Materials Management AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 68151-2992_443f0fbc-137a-433d-a349-74eb0dd3c052 68151-2992 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 Carilion Materials Management AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68151-2996_b9687fa0-6189-4b5c-b459-fd3fe2cd8861 68151-2996 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET ORAL 20120215 NDA AUTHORIZED GENERIC NDA012836 Carilion Materials Management DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 68151-3005_8744e0e2-01ec-4349-bf13-314950fdd04a 68151-3005 HUMAN PRESCRIPTION DRUG Pindolol pindolol TABLET ORAL 19920903 ANDA ANDA074019 Carilion Materials Management PINDOLOL 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-3015_51e83b06-4fcc-4b9b-ba25-b0844015acff 68151-3015 HUMAN PRESCRIPTION DRUG Pilocarpine hydrochloride Pilocarpine hydrochloride TABLET, FILM COATED ORAL 20110913 NDA AUTHORIZED GENERIC NDA020237 Carilion Materials Management PILOCARPINE HYDROCHLORIDE 5 mg/1 Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] N 20181231 68151-3023_84a151cc-d2c1-48b6-8ea7-d5fc8bd2c35b 68151-3023 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160425 ANDA ANDA202554 Carilion Materials Management LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68151-3048_b6c28e93-7309-472a-94d1-88781b7f7c69 68151-3048 HUMAN PRESCRIPTION DRUG CLOMIPRAMINE HYDROCHLORIDE Clomipramine Hydrochloride CAPSULE ORAL 19961231 ANDA ANDA074694 Carilion Materials Management CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68151-3063_fb2229d7-25bc-4798-b07a-793cb6e81fdf 68151-3063 HUMAN PRESCRIPTION DRUG Nephron FA mineral/vitamin supplement TABLET, COATED ORAL 19921101 UNAPPROVED DRUG OTHER Carilion Materials Management IRON; ASCORBIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; PANTOTHENIC ACID; RIBOFLAVIN; THIAMINE; FOLIC ACID; BIOTIN; COBALAMIN 66; 40; 20; 10; 10; 1.7; 1.5; 1; .3; .006 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 68151-3071_bb877d74-46ba-40ef-9f50-65e6ec7234c9 68151-3071 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20070810 ANDA ANDA078494 Carilion Materials Management PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-3083_6f331df9-bf26-4f87-9a02-b1c996e456ac 68151-3083 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20041102 ANDA ANDA075896 Carilion Materials Management FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68151-3084_98d681ac-3b67-4979-ae0d-5b81e9c512a0 68151-3084 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA090365 Carilion Materials Management FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68151-3088_8c8bd724-0045-4370-98f0-7a36591a83a6 68151-3088 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Carilion Materials Management OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68151-3110_e191b251-c4c0-46c6-bbb2-710f51a3368e 68151-3110 HUMAN PRESCRIPTION DRUG Methazolamide methazolamide TABLET ORAL 20100622 ANDA ANDA040062 Carilion Materials Management METHAZOLAMIDE 50 mg/1 N 20181231 68151-3112_18b13473-ae9b-4469-ab36-6a0cf321a375 68151-3112 HUMAN PRESCRIPTION DRUG Triamterene hydrochlorothiazide Triamterene and hydrochlorothiazide TABLET ORAL 19920430 ANDA ANDA073281 Carilion Materials Management TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68151-3114_8525cf49-9c0b-4cfa-8ce2-2ae5170cc146 68151-3114 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Carilion Materials Management DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68151-3118_952416a8-b9eb-4952-bc93-5c7f70c59424 68151-3118 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076273 Carilion Materials Management CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68151-3120_23f7e297-0081-4501-abb5-fbe2caf10c10 68151-3120 HUMAN PRESCRIPTION DRUG Dipentum olsalazine sodium CAPSULE, GELATIN COATED ORAL 19900731 NDA NDA019715 Carilion Materials Management OLSALAZINE SODIUM 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 68151-3494_6989dc60-abad-4644-bfd0-38a9afdf1a86 68151-3494 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA091576 Carilion Materials Management MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68151-3498_0d08efe6-84cb-459e-9591-0b85ddd8cd5f 68151-3498 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA091576 Carilion Materials Management MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68151-3549_8216b360-5b06-467e-87a2-733d16448f85 68151-3549 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate TABLET, FILM COATED ORAL 20151101 ANDA ANDA077006 Carilion Materials Management TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68151-3565_fa1c312b-dbb4-4ce7-9c13-b34a0f4448d4 68151-3565 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 NDA NDA020741 Carilion Materials Management REPAGLINIDE .5 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 68151-3566_86c71274-fd3b-44a1-94f0-16ed18369260 68151-3566 HUMAN PRESCRIPTION DRUG Prandin repaglinide TABLET ORAL 20000103 NDA NDA020741 Carilion Materials Management REPAGLINIDE 1 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 68151-3645_a8261a2f-3381-4684-b33d-f84fec00bf26 68151-3645 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Carilion Materials Management PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68151-3646_94ca4b5e-f671-4056-bbcf-5e12d8129422 68151-3646 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20070511 ANDA ANDA076745 Carilion Materials Management OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68151-3659_badb18dd-50c6-4b08-8d72-c43a29f2fee4 68151-3659 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110602 NDA AUTHORIZED GENERIC NDA020699 Carilion Materials Management VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68151-3660_caa32111-cca5-4762-8b1a-12341a57c7ff 68151-3660 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110602 NDA AUTHORIZED GENERIC NDA020699 Carilion Materials Management VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68151-3708_223f78f6-626e-4bfe-a9b5-a6a139b46e00 68151-3708 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20131203 ANDA ANDA078488 Carilion Materials Management CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 68151-3727_2c300690-04fc-4247-b478-1695e75331ce 68151-3727 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride SOLUTION ORAL 19870515 ANDA ANDA070979 Carilion Materials Management PROPRANOLOL HYDROCHLORIDE 20 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-3792_3ef3a1bb-7da0-4e2e-9913-1ceb4d02b0f9 68151-3792 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Carilion Materials Management PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 68151-3798_7b3823e9-474e-47d6-841f-ff75f0fb3052 68151-3798 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20120817 NDA AUTHORIZED GENERIC NDA021073 Carilion Materials Management PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 68151-3826_d19ab868-f012-410e-ac35-48e6b33433f9 68151-3826 HUMAN PRESCRIPTION DRUG FLAVOXATE HYDROCHLORIDE FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED ORAL 20041222 ANDA ANDA076831 Carilion Materials Management FLAVOXATE HYDROCHLORIDE 100 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68151-3834_68239683-18b4-45e0-b132-db401924df17 68151-3834 HUMAN PRESCRIPTION DRUG AcipHex rabeprazole sodium TABLET, DELAYED RELEASE ORAL 19990819 NDA NDA020973 Carilion Materials Management RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68151-3838_076f9f04-922c-4c67-b65c-d8e866761de9 68151-3838 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20130521 ANDA ANDA078702 Carilion Materials Management CANDESARTAN CILEXETIL 16 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68151-3844_211b3b29-35eb-460c-962b-eba72c1b070a 68151-3844 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20050517 ANDA ANDA077024 Carilion Materials Management CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 68151-3858_9ef43bf9-97cc-4048-a0ba-943fe36937a9 68151-3858 HUMAN PRESCRIPTION DRUG Disopyramide Phosphate Disopyramide Phosphate CAPSULE ORAL 19900930 ANDA ANDA070101 Carilion Materials Management DISOPYRAMIDE PHOSPHATE 100 mg/1 Antiarrhythmic [EPC] N 20181231 68151-3966_9c2ab9df-2bd7-43d2-a86b-715ca8c826ab 68151-3966 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Carilion Materials Management PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68151-3971_b085f4e8-f461-454e-9aff-4f18d9888a8b 68151-3971 HUMAN PRESCRIPTION DRUG Aggrenox aspirin and dipyridamole CAPSULE, EXTENDED RELEASE ORAL 19991219 NDA NDA020884 Carilion Materials Management ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 68151-3977_d9888078-8394-4e42-8c4b-2306f8fa5e69 68151-3977 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110422 ANDA ANDA076447 Carilion Materials Management FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 68151-4021_b93a3a25-6232-459a-9f3b-960c7c7ec794 68151-4021 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20070716 ANDA ANDA040761 Carilion Materials Management HYDROCORTISONE 5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68151-4068_97bea64c-c8e2-4c8c-9586-430b7b19015a 68151-4068 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100629 NDA NDA020381 Carilion Materials Management NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 68151-4069_689b04f5-4d65-4b73-9200-8d217038df7d 68151-4069 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970728 NDA NDA020381 Carilion Materials Management NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 68151-4071_45e703c4-75ec-478f-bf14-7e7e60c0f9f3 68151-4071 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Carilion Materials Management ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68151-4072_39d7ecd4-2ce6-46ff-8b7d-32b2fb91ae55 68151-4072 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Carilion Materials Management ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68151-4073_91ad82ed-4768-4ac3-b44e-8dc21aa03c35 68151-4073 HUMAN PRESCRIPTION DRUG Ropinirole rOPINIRole TABLET ORAL 20080505 ANDA ANDA077852 Carilion Materials Management ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68151-4123_183af410-0b3f-430e-b955-334a9472db6d 68151-4123 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20050517 ANDA ANDA077024 Carilion Materials Management CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 68151-4134_3fc6b4c1-eb67-4c34-8feb-d1563e689592 68151-4134 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20100701 ANDA ANDA077131 Carilion Materials Management RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68151-4145_b8993a7c-905c-4b73-97d4-c46fd26b01b0 68151-4145 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 Carilion Materials Management CANDESARTAN CILEXETIL 4 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68151-4146_59513936-94b1-477b-bac5-5358cf0ea75e 68151-4146 HUMAN PRESCRIPTION DRUG ATACAND Candesartan cilexetil TABLET ORAL 19980914 NDA NDA020838 Carilion Materials Management CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68151-4162_8293c8a8-354f-4be2-8ee5-e90c71d1b1d4 68151-4162 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Carilion Materials Management DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68151-4186_f652a0b0-e301-4886-90e1-f7de84237862 68151-4186 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA078723 Carilion Materials Management MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68151-4210_ff1a49fb-b5fd-4f50-8f9f-ef2718c53478 68151-4210 HUMAN PRESCRIPTION DRUG Theophylline (Anhydrous) Theophylline TABLET, EXTENDED RELEASE ORAL 20070601 ANDA ANDA040560 Carilion Materials Management THEOPHYLLINE ANHYDROUS 600 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68151-4218_2bd8b4bb-8eff-48ca-aa7c-6e038efd0d9d 68151-4218 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 Carilion Materials Management METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68151-4223_2869b1c0-d1cb-4d61-b5aa-29244885731c 68151-4223 HUMAN PRESCRIPTION DRUG Afeditab CR Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021101 ANDA ANDA075128 Carilion Materials Management NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68151-4235_7c25748c-ffc7-452a-999a-414101b232d4 68151-4235 HUMAN PRESCRIPTION DRUG GABITRIL Tiagabine Hydrochloride TABLET, FILM COATED ORAL 20010401 NDA NDA020646 Carilion Materials Management TIAGABINE HYDROCHLORIDE 4 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68151-4243_94a27e1f-b271-4b0a-985e-6ec525416e3c 68151-4243 HUMAN PRESCRIPTION DRUG MagneBind 400 Rx vitamin/mineral supplement with magnesium carbonate, calcium carbonate and folic acid TABLET, FILM COATED ORAL 19991018 UNAPPROVED DRUG OTHER Carilion Materials Management MAGNESIUM CARBONATE; CALCIUM CARBONATE; FOLIC ACID 115; 80; 1 mg/1; mg/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 68151-4247_0130f584-6aea-468e-ac9e-5b64f6ddc195 68151-4247 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20140102 NDA AUTHORIZED GENERIC NDA021228 Carilion Materials Management TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68151-4249_7e5d3d21-15dc-41c6-abf9-0834d4660965 68151-4249 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20060828 ANDA ANDA076420 Carilion Materials Management LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68151-4281_448e25c6-3351-4d69-a0c4-502a53d266c8 68151-4281 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20140102 NDA AUTHORIZED GENERIC NDA021228 Carilion Materials Management TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68151-4290_f59ab6e1-0a1b-46a6-a276-fc4384bf7cba 68151-4290 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20020701 ANDA ANDA075994 Carilion Materials Management LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68151-4319_97424c32-bb2f-4d53-b9d6-20f4af8398a7 68151-4319 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 Carilion Materials Management MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68151-4338_bb23e921-3ab3-4b4d-8301-ce0a1139d08c 68151-4338 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA078723 Carilion Materials Management MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68151-4349_ba1f346d-5bd1-40c4-a772-8fe42e21c6f7 68151-4349 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Carilion Materials Management VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68151-4361_c4975535-bc8e-4746-b391-2db0b0a06a5a 68151-4361 HUMAN PRESCRIPTION DRUG Colestipol Hydrochloride Colestipol Hydrochloride TABLET ORAL 19940719 NDA AUTHORIZED GENERIC NDA020222 Carilion Materials Management COLESTIPOL HYDROCHLORIDE 1 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 68151-4362_a89a5f2d-405a-4015-a320-e6defa0d0fd4 68151-4362 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride TABLET, FILM COATED ORAL 20000901 NDA NDA021176 Carilion Materials Management COLESEVELAM HYDROCHLORIDE 625 mg/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 68151-4374_4e0daaa9-b926-4033-93c4-47fefd919ed3 68151-4374 HUMAN PRESCRIPTION DRUG Budesonide budesonide CAPSULE ORAL 20130823 ANDA ANDA090410 Carilion Materials Management BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68151-4402_4cd341f5-0fd5-4510-8922-30c0666a303d 68151-4402 HUMAN PRESCRIPTION DRUG Dialyvite Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid TABLET, COATED ORAL 19880801 UNAPPROVED DRUG OTHER Carilion Materials Management ASCORBIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; COBALAMIN; BIOTIN; CALCIUM PANTOTHENATE 100; 1.5; 1.7; 20; 10; 1; 6; 300; 10 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 68151-4459_ce743b08-eaec-45ef-94de-60e4dcf76b97 68151-4459 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA202101 Carilion Materials Management ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 68151-4461_b3adc362-236f-4fb1-b266-17944296d4c6 68151-4461 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Carilion Materials Management ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 68151-4471_28e0a855-0be8-480d-9aaf-bdf8be6d2df1 68151-4471 HUMAN PRESCRIPTION DRUG Lescol XL fluvastatin sodium TABLET, EXTENDED RELEASE ORAL 20001006 NDA NDA021192 Carilion Materials Management FLUVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68151-4474_a2ac138d-ff4d-42fd-ac27-c19ac6c31d98 68151-4474 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20110916 ANDA ANDA201680 Carilion Materials Management FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68151-4484_e0dfed21-1067-40b2-b482-210d7c971dc8 68151-4484 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Carilion Materials Management ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68151-4485_14eceffd-5c83-412c-a92c-16242be39f1f 68151-4485 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Carilion Materials Management ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68151-4486_5abe983f-099f-43c0-a0d3-d7afbdf115f8 68151-4486 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Carilion Materials Management ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68151-4487_65551c3d-2206-4944-80f9-8168ee604157 68151-4487 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Carilion Materials Management ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68151-4488_666d35f8-531c-4283-b4ea-b46f9e332846 68151-4488 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20030110 NDA NDA021411 Carilion Materials Management ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68151-4504_e3845c28-be37-4c20-8060-f2934ac581e7 68151-4504 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20090921 ANDA ANDA078635 Carilion Materials Management BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-4633_ff681737-ed6c-4527-8b1e-05fb087c63b4 68151-4633 HUMAN PRESCRIPTION DRUG Benicar olmesartan medoxomil TABLET, FILM COATED ORAL 20020425 NDA NDA021286 Carilion Materials Management OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68151-4634_0b414272-4c09-49a0-af47-bf61498e294c 68151-4634 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20030818 NDA NDA021366 Carilion Materials Management ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68151-4645_bb0bad6d-cb0b-465c-b1ff-7a9d10148ea4 68151-4645 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET ORAL 20140314 ANDA ANDA202871 Carilion Materials Management METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-4668_65425d27-f4a7-4341-b5e1-3a4d3f38245f 68151-4668 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 Carilion Materials Management METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 68151-4672_b7f87c63-31c5-4a1a-952d-d4cff5403c74 68151-4672 HUMAN OTC DRUG Pain Reliever Plus Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Carilion Materials Management ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 68151-4679_ac8894ad-f7e4-4eb1-a9e3-0e38335394c6 68151-4679 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Carilion Materials Management DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68151-4717_bfef4e97-cb4b-4634-9e72-15a8231732ce 68151-4717 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Carilion Materials Management FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68151-4718_491f9aad-a030-4be5-88b0-51e189ca9374 68151-4718 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Carilion Materials Management FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68151-4727_9a379a19-a042-42b5-a8b3-52a0f384de06 68151-4727 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140124 NDA AUTHORIZED GENERIC NDA021427 Carilion Materials Management DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68151-4734_c60443d0-b482-44d2-9479-4b7998dd7eed 68151-4734 HUMAN PRESCRIPTION DRUG Cymbalta Duloxetine hydrochloride CAPSULE, DELAYED RELEASE ORAL 20040824 NDA NDA021427 Carilion Materials Management DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68151-4740_7af108a7-38df-4b45-93ec-15a684a00cb1 68151-4740 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20040404 NDA NDA021688 Carilion Materials Management CINACALCET HYDROCHLORIDE 30 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] N 20181231 68151-4760_e6f9c308-7699-48ef-8c70-c69e938521eb 68151-4760 HUMAN PRESCRIPTION DRUG Campral acamprosate calcium TABLET, DELAYED RELEASE ORAL 20050111 NDA NDA021431 Carilion Materials Management ACAMPROSATE CALCIUM 333 mg/1 E 20171231 68151-4769_7eba11c1-f784-4bf4-b66f-c3f66fd634c9 68151-4769 HUMAN PRESCRIPTION DRUG Pentasa mesalamine CAPSULE ORAL 19930510 NDA NDA020049 Carilion Materials Management MESALAMINE 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 68151-4881_36aa7694-87d7-416d-b9ea-10fc29ecea2f 68151-4881 HUMAN PRESCRIPTION DRUG Rozerem ramelteon TABLET, FILM COATED ORAL 20050722 NDA NDA021782 Carilion Materials Management RAMELTEON 8 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] N 20181231 68151-4952_3770c497-6575-41e9-b795-a60ad5ff2e51 68151-4952 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Carilion Materials Management VARENICLINE TARTRATE 1 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] N 20181231 68151-4953_88048960-8979-4063-8bbf-6000b8cf3c1a 68151-4953 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate TABLET, FILM COATED ORAL 20060510 NDA NDA021928 Carilion Materials Management VARENICLINE TARTRATE .5 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] N 20181231 68151-4980_0d88990d-6f38-4813-ab36-9d859a3453d6 68151-4980 HUMAN PRESCRIPTION DRUG XIFAXAN rifaximin TABLET ORAL 20040725 NDA NDA021361 Carilion Materials Management RIFAXIMIN 200 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 68151-4982_ef4b3594-539a-45ed-873c-5c66900d3606 68151-4982 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Carilion Materials Management ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 68151-5003_fa77ef52-a1a1-485e-96d4-cf2ff432a991 68151-5003 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20060131 NDA NDA021908 Carilion Materials Management LUBIPROSTONE 24 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] N 20181231 68151-5004_892444ae-b9ca-4022-bcd3-f676848f83e8 68151-5004 HUMAN PRESCRIPTION DRUG Ranexa RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060127 NDA NDA021526 Carilion Materials Management RANOLAZINE 500 mg/1 Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68151-5026_afb5eed3-e28b-4a00-8c47-264de34e1515 68151-5026 HUMAN PRESCRIPTION DRUG Dexamethasone Intensol Dexamethasone Intensol SOLUTION, CONCENTRATE ORAL 19830901 ANDA ANDA088252 Carilion Materials Management DEXAMETHASONE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68151-5041_5c9b883b-0ac6-4203-87d3-56bd18cdf42a 68151-5041 HUMAN PRESCRIPTION DRUG Paliperidone Paliperidone TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150924 ANDA ANDA202645 Carilion Materials Management PALIPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] N 20181231 68151-5044_8383cbdc-fff2-4340-a496-e86a69173503 68151-5044 HUMAN PRESCRIPTION DRUG Diovan valsartan TABLET ORAL 20010701 NDA NDA021283 Carilion Materials Management VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68151-5048_b799abd8-149f-488a-98dd-73c367a2a3d7 68151-5048 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070209 NDA NDA022012 Carilion Materials Management CARVEDILOL PHOSPHATE 10 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68151-5049_beee11f4-c6fd-481e-a50d-79f07d47e66f 68151-5049 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070206 NDA NDA022012 Carilion Materials Management CARVEDILOL PHOSPHATE 20 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68151-5050_2bf0765e-6c3d-4398-8890-127e13d511e9 68151-5050 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070214 NDA NDA022012 Carilion Materials Management CARVEDILOL PHOSPHATE 40 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68151-5051_513cdad3-b517-4062-9137-51b0543d524e 68151-5051 HUMAN PRESCRIPTION DRUG COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE ORAL 20070220 NDA NDA022012 Carilion Materials Management CARVEDILOL PHOSPHATE 80 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68151-5113_9d9ca1be-5e19-4c38-8f65-ac46b4f426a1 68151-5113 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20090812 NDA NDA022127 Carilion Materials Management SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 68151-5121_9949b291-8525-4e9d-a533-e79dc6d68f0a 68151-5121 HUMAN PRESCRIPTION DRUG ABILIFY ARIPIPRAZOLE TABLET ORAL 20021115 NDA NDA021436 Carilion Materials Management ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 68151-5135_ca39c719-336a-437e-b7d2-98bb32ecd619 68151-5135 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20080122 NDA NDA021742 Carilion Materials Management NEBIVOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68151-5182_3eb793d8-dc08-4995-940d-c41e2afa3b73 68151-5182 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Extended-Release Hyoscyamine Sulfate Extended-Release TABLET ORAL 20100103 UNAPPROVED DRUG OTHER Carilion Materials Management HYOSCYAMINE SULFATE .375 mg/1 N 20181231 68151-5204_4293136c-1c66-4e16-b40e-0ddb42c59211 68151-5204 HUMAN PRESCRIPTION DRUG Eliphos Calcium Acetate TABLET ORAL 20090201 ANDA ANDA078502 Carilion Materials Management CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 68151-5225_f5ea0edd-30f5-41cb-9623-d9a93f4abead 68151-5225 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, EXTENDED RELEASE ORAL 20170510 ANDA ANDA206260 Carilion Materials Management QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 68151-5230_73cf10a7-acc0-458c-9bdd-84fca4d65827 68151-5230 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20090801 ANDA ANDA077789 Carilion Materials Management CHLORHEXIDINE GLUCONATE .12 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 68151-5295_bfa1c283-a45a-465b-bfec-39a002e58466 68151-5295 HUMAN PRESCRIPTION DRUG Desvenlafaxine desvenlafaxine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204095 Carilion Materials Management DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 68151-5406_7e21fcad-aea8-4621-8391-5e2945b259a4 68151-5406 HUMAN PRESCRIPTION DRUG VESIcare solifenacin succinate TABLET, FILM COATED ORAL 20050105 NDA NDA021518 Carilion Materials Management SOLIFENACIN SUCCINATE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68151-5652_258b12d8-819f-41a6-9116-a1a66a7d69be 68151-5652 HUMAN PRESCRIPTION DRUG Delzicol mesalamine CAPSULE, DELAYED RELEASE ORAL 20130301 NDA NDA204412 Carilion Materials Management MESALAMINE 400 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 68151-5656_8abdb3d6-8491-48b1-99c7-d36b9e5664e1 68151-5656 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride SOLUTION ORAL 19981229 ANDA ANDA074721 Carilion Materials Management DOXEPIN HYDROCHLORIDE 10 mg/mL Tricyclic Antidepressant [EPC] N 20181231 68151-5755_75dfcaf7-41d6-41ae-b358-dad38772bb06 68151-5755 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 NDA NDA022525 Carilion Materials Management MEMANTINE HYDROCHLORIDE 14 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 68151-5817_899dcc94-a2aa-4a1b-b3c6-7c61ed6cd962 68151-5817 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 NDA NDA022525 Carilion Materials Management MEMANTINE HYDROCHLORIDE 28 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 68151-5829_75dfcaf7-41d6-41ae-b358-dad38772bb06 68151-5829 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20111031 NDA NDA022525 Carilion Materials Management MEMANTINE HYDROCHLORIDE 28 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 68151-5878_84181497-355d-43d7-8d42-a30d69b97eaa 68151-5878 HUMAN PRESCRIPTION DRUG Prenatal Vitamins Plus Low Iron Prenatal with Ferrous Fum and Folic Acid TABLET ORAL 20130401 UNAPPROVED DRUG OTHER Carilion Materials Management VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; IRON; ZINC; COPPER 3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] N 20181231 68151-5980_62c04eb3-1970-4f9e-a94d-4e8fecbd0bd9 68151-5980 HUMAN OTC DRUG NICORETTE nicotine polacrilex LOZENGE ORAL 20100301 NDA NDA022360 Carilion Materials Management NICOTINE 2 mg/1 N 20191231 68151-6840_a1622254-ca4b-40ff-909f-5b68aa144fa5 68151-6840 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20130920 ANDA ANDA076378 Carilion Materials Management NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 68151-9200_2f4f9205-6e6e-48bc-b6d9-8ad1b3c111e4 68151-9200 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride SYRUP ORAL 19970212 ANDA ANDA074868 Carilion Materials Management OXYBUTYNIN CHLORIDE 5 mg/5mL Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68152-101_47e3f48c-6c9e-4116-94a7-a08d4ffa4f6f 68152-101 HUMAN PRESCRIPTION DRUG Fusilev levoleucovorin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20080815 NDA NDA020140 Spectrum Pharmaceuticals, Inc. LEVOLEUCOVORIN CALCIUM 50 mg/5mL N 20181231 68152-102_47e3f48c-6c9e-4116-94a7-a08d4ffa4f6f 68152-102 HUMAN PRESCRIPTION DRUG Fusilev levoleucovorin INJECTION, SOLUTION INTRAVENOUS 20110915 NDA NDA020140 Spectrum Pharmaceuticals, Inc. LEVOLEUCOVORIN CALCIUM 10 mg/mL N 20181231 68152-103_281135c5-e842-4a8f-85d9-462c0ee8c51c 68152-103 HUMAN PRESCRIPTION DRUG Zevalin ibritumomab tiuxetan KIT 20020219 BLA BLA125019 Spectrum Pharmaceuticals, Inc. N 20181231 68152-108_0b349468-289d-4267-bc4e-456ae16896e0 68152-108 HUMAN PRESCRIPTION DRUG Beleodaq Belinostat INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20140721 NDA NDA206256 Spectrum Pharmaceuticals, Inc. BELINOSTAT 500 mg/10mL Histone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA] N 20181231 68152-109_5d7cc99a-4fec-4e63-a8b4-86e2d8d6ceb4 68152-109 HUMAN PRESCRIPTION DRUG EVOMELA Melphalan INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160331 NDA NDA207155 Spectrum Pharmaceuticals, Inc. MELPHALAN HYDROCHLORIDE 50 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 68163-081_6bcbff93-c2b7-4ffa-bd41-5e6bc08f7ff9 68163-081 HUMAN OTC DRUG Chewable Adult Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20130603 OTC MONOGRAPH FINAL part343 Raritan Pharmaceuticals Inc ASPIRIN 81 mg/1 N 20181231 68163-709_893fa061-ba83-485e-a9dc-822313b6065d 68163-709 HUMAN OTC DRUG equate infants gas relief Simethicone EMULSION ORAL 20100308 OTC MONOGRAPH FINAL part332 Raritan Pharmaceuticals Inc DIMETHICONE 20 mg/.3mL N 20181231 68169-0012_6a31f3f5-eb6e-44de-878c-9994d9acefac 68169-0012 HUMAN OTC DRUG TODAYS HEALTH SINUS NASAL RELIEF OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20101025 OTC MONOGRAPH FINAL part341 TAI GUK PHARM. CO., LTD. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL E 20171231 68169-0013_856cfbbe-f4c8-4266-9792-b8dffe01fbad 68169-0013 HUMAN OTC DRUG TODAYS HEALTH NASAL RELIEF ORIGINAL OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20101022 OTC MONOGRAPH FINAL part341 TAI GUK PHARM. CO., LTD. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL E 20171231 68169-0014_0de2a331-16a4-4d80-9dcb-0704c226ff27 68169-0014 HUMAN OTC DRUG TODAYS HEALTH NASAL RELIEF EXTRA MOISTURIZING OXYMETAZOLINE HYDROCHLORIDE SPRAY NASAL 20101111 OTC MONOGRAPH FINAL part341 TAI GUK PHARM. CO., LTD. OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL E 20171231 68169-0022_cb15cade-4fca-43a3-b4fb-835c9f0f5f7f 68169-0022 HUMAN OTC DRUG SHOPKO TRIPLE ANTIBIOTIC BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE OINTMENT TOPICAL 20101220 OTC MONOGRAPH FINAL part333B TAI GUK PHARM. CO., LTD. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 68169-0049_b99dff4c-9cf4-45f8-ab70-4d5450b85235 68169-0049 HUMAN OTC DRUG FAMILY CARE ANTI-ITCH DIPHENHYDRAMINE HYDROCHLORIDE CREAM TOPICAL 20100416 OTC MONOGRAPH NOT FINAL part348 TAI GUK PHARM. CO., LTD. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/g; mg/g E 20171231 68169-0061_4c3ed393-93c4-4904-a6ed-3f19082244dc 68169-0061 HUMAN OTC DRUG FIRST AID RESEARCH ZINC OXYDE PLUS MENTHOL AND ZINC OXIDE OINTMENT TOPICAL 20100928 OTC MONOGRAPH FINAL part347 TAI GUK PHARM. CO., LTD. MENTHOL; ZINC OXIDE .44; 20 g/100g; g/100g N 20181231 68169-0094_43cc6f19-e45b-4696-a131-c5e1ac0cca8e 68169-0094 HUMAN OTC DRUG First Aid Research Bacitracin with Zinc Bacitracin Zinc OINTMENT TOPICAL 20100407 OTC MONOGRAPH FINAL part333B TAI GUK PHARM. CO., LTD. BACITRACIN ZINC 500 [USP'U]/g N 20181231 68169-0127_8f6ba017-40c2-4a36-999a-886a1df70cca 68169-0127 HUMAN OTC DRUG PREMIER VALUE ALLERGY DIPHENHYDRAMINE HYDROCHLORIDE CREAM TOPICAL 20100917 OTC MONOGRAPH NOT FINAL part348 TAI GUK PHARM. CO., LTD. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g E 20171231 68169-0128_e67f37e1-e527-4045-b3eb-689f4addfcc4 68169-0128 HUMAN OTC DRUG PREMIER VALUE DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20100930 OTC MONOGRAPH FINAL part347 TAI GUK PHARM. CO., LTD. ZINC OXIDE .4 g/g E 20171231 68169-0129_c6606008-f13d-47f0-b836-4459b05021a9 68169-0129 HUMAN OTC DRUG PREMIER VALUE TRIPLE ANTIBIOTIC PLUS BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE OINTMENT TOPICAL 20101104 OTC MONOGRAPH FINAL part333B TAI GUK PHARM. CO., LTD. BACITRACIN ZINC; NEOMYCIN; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g E 20171231 68169-0130_8dabf91e-3a88-4053-8e9b-a8ef6b51f103 68169-0130 HUMAN OTC DRUG PREMIER VALUE ZINC OXIDE ZINC OXIDE OINTMENT TOPICAL 20101108 OTC MONOGRAPH FINAL part347 TAI GUK PHARM. CO., LTD. ZINC OXIDE 20 g/100g E 20171231 68169-0375_65933290-eab5-456c-9ea5-c9d5ff3c614c 68169-0375 HUMAN OTC DRUG WESTERN FAMILY DIAPER RASH ZINC OXIDE OINTMENT TOPICAL 20101005 OTC MONOGRAPH FINAL part347 TAI GUK PHARM. CO., LTD. ZINC OXIDE .4 g/g E 20171231 68169-3050_87aecaaf-36ab-452c-bf89-cb5e3ac3a4c2 68169-3050 HUMAN OTC DRUG DG ATHLETES FOOT TOLNAFTATE CREAM TOPICAL 20101210 OTC MONOGRAPH FINAL part333C TAI GUK PHARM. CO., LTD. TOLNAFTATE 10 mg/g E 20171231 68169-3229_026cca97-9385-4bc9-9465-e439cb40586a 68169-3229 HUMAN OTC DRUG BEING WELL DIAPER RASH CREAMY ZINC OXIDE OINTMENT TOPICAL 20101117 OTC MONOGRAPH FINAL part347 TAI GUK PHARM. CO., LTD. ZINC OXIDE .1 g/g E 20171231 68169-4058_e1503304-00b8-4364-b435-0d1ed448eff3 68169-4058 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY DIAPER RASH ZINC OXIDE CREAM TOPICAL 20100920 OTC MONOGRAPH FINAL part347 TAI GUK PHARM. CO., LTD. ZINC OXIDE .1 g/g E 20171231 68169-4059_5b8845a7-3d0a-4583-92b0-d875546394f5 68169-4059 HUMAN OTC DRUG GOOD NEIGHBOR PHARMACY ACNE TREATMENT BENZOYL PEROXIDE CREAM TOPICAL 20101117 OTC MONOGRAPH NOT FINAL part333D TAI GUK PHARM. CO., LTD. BENZOYL PEROXIDE 10 g/100g E 20171231 68169-9930_4a7f4a56-1609-4ae0-9a2f-ff15d47cec32 68169-9930 HUMAN OTC DRUG CVS CHILDREN DECONGESTANT NOSE DROPS PHENYLEPHRINE HYDROCHLORIDE SOLUTION NASAL 20100712 OTC MONOGRAPH FINAL part341 TAI GUK PHARM. CO., LTD. PHENYLEPHRINE HYDROCHLORIDE 1.25 mg/mL E 20171231 68180-099_8c4ca39e-aefb-43cd-96fa-31f0c497906c 68180-099 HUMAN PRESCRIPTION DRUG levetiracetam levetiracetam SOLUTION ORAL 20141101 ANDA ANDA090893 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 100 mg/mL Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68180-101_444189bc-bffb-4d0a-8d17-02e8983cd5fe 68180-101 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-102_444189bc-bffb-4d0a-8d17-02e8983cd5fe 68180-102 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-103_444189bc-bffb-4d0a-8d17-02e8983cd5fe 68180-103 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-104_444189bc-bffb-4d0a-8d17-02e8983cd5fe 68180-104 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 12.5; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-105_444189bc-bffb-4d0a-8d17-02e8983cd5fe 68180-105 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 160 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-112_4cd64239-a74c-4131-a07b-677fc192940f 68180-112 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68180-113_4cd64239-a74c-4131-a07b-677fc192940f 68180-113 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68180-114_4cd64239-a74c-4131-a07b-677fc192940f 68180-114 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090101 ANDA ANDA078154 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68180-115_4cd64239-a74c-4131-a07b-677fc192940f 68180-115 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA090025 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68180-117_9fb92985-c4ee-4d83-9390-9dc9632021a2 68180-117 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091399 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 68180-118_9fb92985-c4ee-4d83-9390-9dc9632021a2 68180-118 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20110912 ANDA ANDA091399 Lupin Pharmaceuticals, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 68180-121_db58498b-ab09-4707-9bf4-2db878ace430 68180-121 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 Lupin Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-122_db58498b-ab09-4707-9bf4-2db878ace430 68180-122 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20060111 ANDA ANDA065229 Lupin Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-123_660825a1-8953-40d5-a6b4-649fa0fae6ce 68180-123 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20060111 20200101 ANDA ANDA065234 Lupin Pharmaceuticals, Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-124_660825a1-8953-40d5-a6b4-649fa0fae6ce 68180-124 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20060111 20200601 ANDA ANDA065234 Lupin Pharmaceuticals, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-128_f3afb6be-b2ee-49e0-95dd-150c29a665d0 68180-128 HUMAN PRESCRIPTION DRUG Fenofibric acid Fenofibric acid CAPSULE, DELAYED RELEASE ORAL 20131217 ANDA ANDA200750 Lupin Pharmaceuticals, Inc. CHOLINE FENOFIBRATE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 68180-129_f3afb6be-b2ee-49e0-95dd-150c29a665d0 68180-129 HUMAN PRESCRIPTION DRUG Fenofibric acid Fenofibric acid CAPSULE, DELAYED RELEASE ORAL 20131217 ANDA ANDA200750 Lupin Pharmaceuticals, Inc. CHOLINE FENOFIBRATE 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 68180-130_178c521e-e5c1-4f95-ab72-b1529e65eab5 68180-130 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20130222 NDA AUTHORIZED GENERIC NDA021695 Lupin Pharmaceuticals, Inc. FENOFIBRATE 43 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 68180-131_178c521e-e5c1-4f95-ab72-b1529e65eab5 68180-131 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20130222 NDA AUTHORIZED GENERIC NDA021695 Lupin Pharmaceuticals, Inc. FENOFIBRATE 130 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 68180-134_11897886-bd4b-4996-ae46-018f947603f0 68180-134 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20150909 ANDA ANDA202127 Lupin Pharmaceuticals, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 68180-135_891c6d47-ffa0-4bb2-8e33-21eacb7996cb 68180-135 HUMAN PRESCRIPTION DRUG Escitalopram Escitslopram TABLET ORAL 20120910 ANDA ANDA078169 Lupin Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68180-136_891c6d47-ffa0-4bb2-8e33-21eacb7996cb 68180-136 HUMAN PRESCRIPTION DRUG Escitalopram Escitslopram TABLET ORAL 20120910 ANDA ANDA078169 Lupin Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68180-137_891c6d47-ffa0-4bb2-8e33-21eacb7996cb 68180-137 HUMAN PRESCRIPTION DRUG Escitalopram Escitslopram TABLET ORAL 20120910 ANDA ANDA078169 Lupin Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68180-141_2a1e2ec2-12a8-44c0-81e4-0472663e33a6 68180-141 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20120827 ANDA ANDA090445 Lupin Pharmaceuticals, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68180-142_2a1e2ec2-12a8-44c0-81e4-0472663e33a6 68180-142 HUMAN PRESCRIPTION DRUG Nabumetone nabumetone TABLET, FILM COATED ORAL 20120827 ANDA ANDA090445 Lupin Pharmaceuticals, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68180-150_77c29140-f626-4c61-a461-6672e72b305d 68180-150 HUMAN PRESCRIPTION DRUG Famotidine Famotidine POWDER, FOR SUSPENSION ORAL 20100629 ANDA ANDA090440 Lupin Pharmaceuticals, Inc FAMOTIDINE 40 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 68180-153_d0744218-e3f5-49fe-a611-e83fa7840aaf 68180-153 HUMAN PRESCRIPTION DRUG DESLORATADINE DESLORATADINE TABLET, FILM COATED ORAL 20130214 ANDA ANDA078352 Lupin Pharmaceuticals, Inc. DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 68180-160_de93728f-071f-4abf-8de7-7104b93b91f7 68180-160 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150818 ANDA ANDA065398 Lupin Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68180-161_de93728f-071f-4abf-8de7-7104b93b91f7 68180-161 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150818 ANDA ANDA065399 Lupin Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68180-162_30d42e13-78d0-4a7f-9b45-eccfd735ae15 68180-162 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20150818 ANDA ANDA065400 Lupin Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68180-166_44da4083-fdc6-46ac-8b2b-9b3829b5caf7 68180-166 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE CAPSULE ORAL 20150327 ANDA ANDA090439 Lupin Pharmaceuticals, Inc. VANCOMYCIN HYDROCHLORIDE 125 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 68180-167_44da4083-fdc6-46ac-8b2b-9b3829b5caf7 68180-167 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE CAPSULE ORAL 20150327 ANDA ANDA090439 Lupin Pharmaceuticals, Inc. VANCOMYCIN HYDROCHLORIDE 250 mg/1 Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 68180-180_56b86799-1d9a-4551-bb62-96b7961372f9 68180-180 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20080423 ANDA ANDA065392 Lupin Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-181_d3709fb2-0268-4467-a118-2f9dc5e0a13d 68180-181 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20080423 ANDA ANDA065396 Lupin Pharmaceuticals, Inc. CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-182_d3709fb2-0268-4467-a118-2f9dc5e0a13d 68180-182 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20080423 ANDA ANDA065396 Lupin Pharmaceuticals, Inc. CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-185_3aab3fb7-ec62-4694-a7d3-2402886e155d 68180-185 HUMAN PRESCRIPTION DRUG Mefenamic Acid Mefenamic Acid CAPSULE ORAL 20110722 ANDA ANDA091322 Lupin Pharmaceuticals, Inc. MEFENAMIC ACID 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68180-193_1e6d2693-4656-49a8-b064-ba967690578c 68180-193 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20140807 ANDA ANDA091351 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 40 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-194_1e6d2693-4656-49a8-b064-ba967690578c 68180-194 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20140807 ANDA ANDA091351 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-195_1e6d2693-4656-49a8-b064-ba967690578c 68180-195 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20140807 ANDA ANDA091351 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; TELMISARTAN 25; 80 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-196_b6b52c46-0531-4a17-80e1-ece754e0968d 68180-196 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA201586 Lupin Pharmaceuticals, Inc. TELMISARTAN; AMLODIPINE BESYLATE 40; 5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68180-197_b6b52c46-0531-4a17-80e1-ece754e0968d 68180-197 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA201586 Lupin Pharmaceuticals, Inc. TELMISARTAN; AMLODIPINE BESYLATE 40; 10 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68180-198_b6b52c46-0531-4a17-80e1-ece754e0968d 68180-198 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA201586 Lupin Pharmaceuticals, Inc. TELMISARTAN; AMLODIPINE BESYLATE 80; 5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68180-199_b6b52c46-0531-4a17-80e1-ece754e0968d 68180-199 HUMAN PRESCRIPTION DRUG Telmisartan and Amlodipine Telmisartan and Amlodipine TABLET ORAL 20140108 ANDA ANDA201586 Lupin Pharmaceuticals, Inc. TELMISARTAN; AMLODIPINE BESYLATE 80; 10 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68180-202_f53d0f20-e16c-42b6-b755-b17d4b9a9377 68180-202 HUMAN PRESCRIPTION DRUG SUPRAX CEFIXIME POWDER, FOR SUSPENSION ORAL 20040301 ANDA ANDA065129 Lupin Pharmaceuticals, Inc. CEFIXIME 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-210_deb2d34c-8675-422d-944e-e8026c82f6c2 68180-210 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 20190731 ANDA ANDA078232 Lupin Pharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-211_deb2d34c-8675-422d-944e-e8026c82f6c2 68180-211 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 20190131 ANDA ANDA078232 Lupin Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-212_deb2d34c-8675-422d-944e-e8026c82f6c2 68180-212 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 20181231 ANDA ANDA078232 Lupin Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-215_c5a05595-80eb-44af-a812-52beb290793e 68180-215 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA078245 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 68180-216_c5a05595-80eb-44af-a812-52beb290793e 68180-216 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA078245 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 68180-217_c5a05595-80eb-44af-a812-52beb290793e 68180-217 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20101006 ANDA ANDA078245 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 68180-220_5513adc0-971a-4246-a1b0-dbb6a9e6b038 68180-220 HUMAN PRESCRIPTION DRUG RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA078964 Lupin Pharmaceuticals, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68180-221_e322c099-9221-4e47-8fb5-605de6032158 68180-221 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20140320 ANDA ANDA090860 Lupin Pharmaceuticals, Inc. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 68180-222_e322c099-9221-4e47-8fb5-605de6032158 68180-222 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20140320 ANDA ANDA090892 Lupin Pharmaceuticals, Inc. NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 68180-223_e322c099-9221-4e47-8fb5-605de6032158 68180-223 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, EXTENDED RELEASE ORAL 20140320 ANDA ANDA090446 Lupin Pharmaceuticals, Inc. NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 68180-229_00171da8-b6f1-4f4d-afd9-04f7ea35dd04 68180-229 HUMAN PRESCRIPTION DRUG Memantine hydrochloride Memantine hydrochloride TABLET, FILM COATED ORAL 20150713 ANDA ANDA090051 Lupin Pharmaceuticals, Inc. MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 68180-230_00171da8-b6f1-4f4d-afd9-04f7ea35dd04 68180-230 HUMAN PRESCRIPTION DRUG Memantine hydrochloride Memantine hydrochloride TABLET, FILM COATED ORAL 20150713 ANDA ANDA090051 Lupin Pharmaceuticals, Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 68180-235_fbb31482-9ac8-48c6-b814-5d467f22051b 68180-235 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20100315 ANDA ANDA078263 Lupin Pharmaceuticals, Inc PERINDOPRIL ERBUMINE 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 68180-236_fbb31482-9ac8-48c6-b814-5d467f22051b 68180-236 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20100315 ANDA ANDA078263 Lupin Pharmaceuticals, Inc PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 68180-237_fbb31482-9ac8-48c6-b814-5d467f22051b 68180-237 HUMAN PRESCRIPTION DRUG Perindopril Erbumine Perindopril Erbumine TABLET ORAL 20100315 ANDA ANDA078263 Lupin Pharmaceuticals, Inc PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 68180-240_8208d41a-7380-4427-b3a5-153800f42672 68180-240 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA078424 Lupin Pharmaceuticals, Inc. LEVOFLOXACIN 250 mg/1 N 20181231 68180-241_8208d41a-7380-4427-b3a5-153800f42672 68180-241 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA078424 Lupin Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 68180-242_8208d41a-7380-4427-b3a5-153800f42672 68180-242 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110620 ANDA ANDA078424 Lupin Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 68180-246_865d923e-be26-4727-a629-883f81b2a456 68180-246 HUMAN PRESCRIPTION DRUG memantine hydrochloride memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171225 ANDA ANDA206028 Lupin Pharmaceuticals, Inc. MEMANTINE HYDROCHLORIDE 7 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 68180-247_865d923e-be26-4727-a629-883f81b2a456 68180-247 HUMAN PRESCRIPTION DRUG memantine hydrochloride memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171225 ANDA ANDA206028 Lupin Pharmaceuticals, Inc. MEMANTINE HYDROCHLORIDE 14 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 68180-248_865d923e-be26-4727-a629-883f81b2a456 68180-248 HUMAN PRESCRIPTION DRUG memantine hydrochloride memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171225 ANDA ANDA206028 Lupin Pharmaceuticals, Inc. MEMANTINE HYDROCHLORIDE 21 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 68180-249_865d923e-be26-4727-a629-883f81b2a456 68180-249 HUMAN PRESCRIPTION DRUG memantine hydrochloride memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171225 ANDA ANDA206028 Lupin Pharmaceuticals, Inc. MEMANTINE HYDROCHLORIDE 28 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 68180-250_3cee9e01-d765-4acf-944a-65320002e643 68180-250 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20110120 ANDA ANDA078691 Lupin Pharmaceuticals, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68180-251_3cee9e01-d765-4acf-944a-65320002e643 68180-251 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20110120 ANDA ANDA078691 Lupin Pharmaceuticals, Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68180-252_3cee9e01-d765-4acf-944a-65320002e643 68180-252 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20110120 ANDA ANDA078691 Lupin Pharmaceuticals, Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68180-253_3cee9e01-d765-4acf-944a-65320002e643 68180-253 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20110120 ANDA ANDA078691 Lupin Pharmaceuticals, Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68180-265_13a76e8c-fe3b-4b07-a665-80d3734c4b4f 68180-265 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078790 Lupin Pharmaceuticals, Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 68180-266_13a76e8c-fe3b-4b07-a665-80d3734c4b4f 68180-266 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078790 Lupin Pharmaceuticals, Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 68180-267_13a76e8c-fe3b-4b07-a665-80d3734c4b4f 68180-267 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20080729 ANDA ANDA078790 Lupin Pharmaceuticals, Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 68180-276_65f5d6e7-c7c6-42dc-bd73-b32251c02651 68180-276 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20150105 ANDA ANDA201677 Lupin Pharmaceuticals, Inc. VALSARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-277_65f5d6e7-c7c6-42dc-bd73-b32251c02651 68180-277 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20150105 ANDA ANDA201677 Lupin Pharmaceuticals, Inc. VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-278_65f5d6e7-c7c6-42dc-bd73-b32251c02651 68180-278 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20150105 ANDA ANDA201677 Lupin Pharmaceuticals, Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-279_65f5d6e7-c7c6-42dc-bd73-b32251c02651 68180-279 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET ORAL 20150105 ANDA ANDA201677 Lupin Pharmaceuticals, Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-280_be4eea6b-8d56-410a-9218-1653c7865437 68180-280 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET ORAL 20090704 ANDA ANDA078939 Lupin Pharmaceuticals, Inc. ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] N 20181231 68180-281_be4eea6b-8d56-410a-9218-1653c7865437 68180-281 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET ORAL 20090704 ANDA ANDA078939 Lupin Pharmaceuticals, Inc. ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] N 20181231 68180-284_ef30ee51-1dd9-4467-ae4b-cb92bd7bc3f0 68180-284 HUMAN PRESCRIPTION DRUG LAMIVUDINE AND ZIDOVUDINE LAMIVUDINE AND ZIDOVUDINE TABLET ORAL 20120515 ANDA ANDA090246 Lupin Pharmaceuticals, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68180-285_9df90e3e-1e87-45d5-9fa9-74d44f371128 68180-285 HUMAN PRESCRIPTION DRUG rifabutin rifabutin CAPSULE ORAL 20140326 ANDA ANDA090033 Lupin Pharmaceuticals, Inc. RIFABUTIN 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 68180-286_e1e30726-5522-4214-b103-a016a08fdfcb 68180-286 HUMAN PRESCRIPTION DRUG ABACAVIR, LAMIVUDINE AND ZIDOVUDINE ABACAVIR , LAMIVUDINE AND ZIDOVUDINE TABLET ORAL 20131217 ANDA ANDA202912 Lupin Pharmaceuticals, Inc. LAMIVUDINE; ZIDOVUDINE; ABACAVIR SULFATE 150; 300; 300 mg/1; mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68180-288_7e35908d-8dce-4686-a4f0-e065a0ef89c3 68180-288 HUMAN PRESCRIPTION DRUG Abacavir and Lamivudine Abacavir and Lamivudine TABLET, FILM COATED ORAL 20170328 ANDA ANDA204990 Lupin Pharmaceuticals, Inc. ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68180-294_7fc4b2f0-1969-4b4b-92d2-14e20fccade6 68180-294 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090694 Lupin Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68180-295_7fc4b2f0-1969-4b4b-92d2-14e20fccade6 68180-295 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090694 Lupin Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68180-296_7fc4b2f0-1969-4b4b-92d2-14e20fccade6 68180-296 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090694 Lupin Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68180-297_7fc4b2f0-1969-4b4b-92d2-14e20fccade6 68180-297 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20150525 ANDA ANDA090694 Lupin Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68180-302_d931a627-ae6c-4880-bda1-6ed1e3e843f4 68180-302 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20030725 ANDA ANDA065135 Lupin Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-303_d931a627-ae6c-4880-bda1-6ed1e3e843f4 68180-303 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20030725 ANDA ANDA065135 Lupin Pharmaceuticals, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-311_cb66563d-2330-427e-914e-1847fcd9972d 68180-311 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20101221 ANDA ANDA090443 Lupin Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68180-312_cb66563d-2330-427e-914e-1847fcd9972d 68180-312 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20101221 ANDA ANDA090442 Lupin Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68180-313_cb66563d-2330-427e-914e-1847fcd9972d 68180-313 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20101221 ANDA ANDA090441 Lupin Pharmaceuticals, Inc. IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68180-314_f15dcc43-e01d-4c06-8eb8-b6993de8794c 68180-314 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100416 ANDA ANDA090444 Lupin Pharmaceuticals, Inc. IMIPRAMINE PAMOATE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68180-315_f15dcc43-e01d-4c06-8eb8-b6993de8794c 68180-315 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100416 ANDA ANDA090444 Lupin Pharmaceuticals, Inc. IMIPRAMINE PAMOATE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68180-316_f15dcc43-e01d-4c06-8eb8-b6993de8794c 68180-316 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100416 ANDA ANDA090444 Lupin Pharmaceuticals, Inc. IMIPRAMINE PAMOATE 125 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68180-317_f15dcc43-e01d-4c06-8eb8-b6993de8794c 68180-317 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20100416 ANDA ANDA090444 Lupin Pharmaceuticals, Inc. IMIPRAMINE PAMOATE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68180-319_91ebb4e2-ff3b-4bf5-8d1c-36f84cd01b7d 68180-319 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170614 ANDA ANDA090693 Lupin Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68180-320_91ebb4e2-ff3b-4bf5-8d1c-36f84cd01b7d 68180-320 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170614 ANDA ANDA090693 Lupin Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68180-322_8ab60126-de1c-40e6-871a-dbc42fe569a4 68180-322 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091124 Lupin Pharmaceuticals, Inc. ESZOPICLONE 1 mg/1 CIV N 20181231 68180-323_8ab60126-de1c-40e6-871a-dbc42fe569a4 68180-323 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091124 Lupin Pharmaceuticals, Inc. ESZOPICLONE 2 mg/1 CIV N 20181231 68180-324_8ab60126-de1c-40e6-871a-dbc42fe569a4 68180-324 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091124 Lupin Pharmaceuticals, Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 68180-331_b2825e7d-d395-4f21-8b13-4a40f6c7e8c2 68180-331 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Lupin Pharmaceuticals, Inc. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-332_b2825e7d-d395-4f21-8b13-4a40f6c7e8c2 68180-332 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Lupin Pharmaceuticals, Inc. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-333_b2825e7d-d395-4f21-8b13-4a40f6c7e8c2 68180-333 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Lupin Pharmaceuticals, Inc. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-334_b2825e7d-d395-4f21-8b13-4a40f6c7e8c2 68180-334 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20120302 ANDA ANDA077560 Lupin Pharmaceuticals, Inc. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-336_7e175d81-ab7d-4f9b-92cd-c2144fb1869c 68180-336 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110930 ANDA ANDA090692 Lupin Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68180-337_7e175d81-ab7d-4f9b-92cd-c2144fb1869c 68180-337 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20110930 ANDA ANDA090692 Lupin Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68180-338_f7e712aa-b1bf-4ecd-8d72-2b1cb68611ce 68180-338 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20160201 ANDA ANDA091664 Lupin Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68180-339_f7e712aa-b1bf-4ecd-8d72-2b1cb68611ce 68180-339 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20160201 ANDA ANDA091664 Lupin Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68180-351_47afd39f-0d7c-4ac2-9a65-045e24f3c508 68180-351 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Lupin Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68180-352_47afd39f-0d7c-4ac2-9a65-045e24f3c508 68180-352 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Lupin Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68180-353_47afd39f-0d7c-4ac2-9a65-045e24f3c508 68180-353 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Lupin Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68180-360_de4b026a-74c1-404f-9055-de1e5b081fc1 68180-360 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20120713 ANDA ANDA090856 Lupin Pharmaceuticals, Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68180-361_de4b026a-74c1-404f-9055-de1e5b081fc1 68180-361 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20120713 ANDA ANDA090856 Lupin Pharmaceuticals, Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68180-362_f604e067-cfa6-4230-8e1e-bf39401e7704 68180-362 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20151123 ANDA ANDA204019 Lupin Pharmaceuticals, Inc. FENOFIBRATE 54 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68180-363_f604e067-cfa6-4230-8e1e-bf39401e7704 68180-363 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20151123 ANDA ANDA204019 Lupin Pharmaceuticals, Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68180-376_deb2d34c-8675-422d-944e-e8026c82f6c2 68180-376 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20171101 ANDA ANDA078232 Lupin Pharmaceuticals, Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-377_deb2d34c-8675-422d-944e-e8026c82f6c2 68180-377 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20171101 ANDA ANDA078232 Lupin Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-378_deb2d34c-8675-422d-944e-e8026c82f6c2 68180-378 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20171101 ANDA ANDA078232 Lupin Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-379_d4fb320e-da90-4158-884c-5ab318214bc7 68180-379 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120214 ANDA ANDA091424 Lupin Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 45 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68180-380_d4fb320e-da90-4158-884c-5ab318214bc7 68180-380 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120214 ANDA ANDA091424 Lupin Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 90 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68180-381_d4fb320e-da90-4158-884c-5ab318214bc7 68180-381 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, EXTENDED RELEASE ORAL 20120214 ANDA ANDA091424 Lupin Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 135 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68180-392_50b98e4c-606c-4337-b579-9214ea21ea86 68180-392 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN KIT 20140606 ANDA ANDA200563 Lupin Pharmaceuticals, Inc. N 20181231 68180-393_50b98e4c-606c-4337-b579-9214ea21ea86 68180-393 HUMAN PRESCRIPTION DRUG CIPROFLOXACIN CIPROFLOXACIN KIT 20140606 ANDA ANDA200563 Lupin Pharmaceuticals, Inc. N 20181231 68180-395_89c7765b-4bdd-475f-90eb-df2fb3cf45fa 68180-395 HUMAN PRESCRIPTION DRUG celecoxib celecoxib CAPSULE ORAL 20150807 ANDA ANDA202240 Lupin Pharmaceuticals, Inc. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68180-396_89c7765b-4bdd-475f-90eb-df2fb3cf45fa 68180-396 HUMAN PRESCRIPTION DRUG celecoxib celecoxib CAPSULE ORAL 20150807 ANDA ANDA202240 Lupin Pharmaceuticals, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68180-397_89c7765b-4bdd-475f-90eb-df2fb3cf45fa 68180-397 HUMAN PRESCRIPTION DRUG celecoxib celecoxib CAPSULE ORAL 20150807 ANDA ANDA202240 Lupin Pharmaceuticals, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68180-398_89c7765b-4bdd-475f-90eb-df2fb3cf45fa 68180-398 HUMAN PRESCRIPTION DRUG celecoxib celecoxib CAPSULE ORAL 20150807 ANDA ANDA202240 Lupin Pharmaceuticals, Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68180-401_396227ec-84a8-48c7-9f12-59eb0dd2b40f 68180-401 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL POWDER, FOR SUSPENSION ORAL 20051201 ANDA ANDA065261 Lupin Pharmaceuticals, Inc. CEFPROZIL 125 mg/5mL N 20181231 68180-402_396227ec-84a8-48c7-9f12-59eb0dd2b40f 68180-402 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL POWDER, FOR SUSPENSION ORAL 20051201 ANDA ANDA065261 Lupin Pharmaceuticals, Inc. CEFPROZIL 250 mg/5mL N 20181231 68180-403_3cd97669-853d-4a07-bbd3-3aa88f751b5c 68180-403 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20051201 ANDA ANDA065276 Lupin Pharmaceuticals, Inc. CEFPROZIL 250 mg/1 N 20181231 68180-404_3cd97669-853d-4a07-bbd3-3aa88f751b5c 68180-404 HUMAN PRESCRIPTION DRUG CEFPROZIL CEFPROZIL TABLET ORAL 20051201 ANDA ANDA065276 Lupin Pharmaceuticals, Inc. CEFPROZIL 500 mg/1 N 20181231 68180-405_7bc94c16-7a36-4c28-add9-71c125bcb784 68180-405 HUMAN PRESCRIPTION DRUG CEFIXIME CEFIXIME POWDER, FOR SUSPENSION ORAL 20150420 ANDA ANDA065129 Lupin Pharmaceuticals, Inc. CEFIXIME 100 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 68180-407_7bc94c16-7a36-4c28-add9-71c125bcb784 68180-407 HUMAN PRESCRIPTION DRUG CEFIXIME CEFIXIME POWDER, FOR SUSPENSION ORAL 20150420 ANDA ANDA065355 Lupin Pharmaceuticals, Inc. CEFIXIME 200 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 68180-410_ccd98c02-1e9c-4cc0-b8ad-6c347efa5b60 68180-410 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121023 ANDA ANDA201531 Lupin Pharmaceuticals, Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-411_ccd98c02-1e9c-4cc0-b8ad-6c347efa5b60 68180-411 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121023 ANDA ANDA201531 Lupin Pharmaceuticals, Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-412_ccd98c02-1e9c-4cc0-b8ad-6c347efa5b60 68180-412 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20121023 ANDA ANDA201531 Lupin Pharmaceuticals, Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-413_d7b3392d-532c-4c81-badd-f61c89cf5244 68180-413 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130404 ANDA ANDA201524 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 150 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-414_d7b3392d-532c-4c81-badd-f61c89cf5244 68180-414 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130404 ANDA ANDA201524 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5; 300 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-422_cf9069f5-b5be-49a7-bcd0-5f3e26aef7f9 68180-422 HUMAN PRESCRIPTION DRUG Moxifloxacin Moxifloxacin SOLUTION/ DROPS OPHTHALMIC 20170701 ANDA ANDA202867 Lupin Pharmaceuticals, Inc. MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68180-429_77e70dcd-4620-4f32-84ec-58464aa38567 68180-429 HUMAN PRESCRIPTION DRUG bimatoprost bimatoprost SOLUTION/ DROPS OPHTHALMIC 20150513 ANDA ANDA203991 Lupin Pharmaceuticals, Inc. BIMATOPROST .3 mg/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] N 20181231 68180-435_92cdc5e9-3a05-4361-83d2-2c0df862596a 68180-435 HUMAN PRESCRIPTION DRUG Gatifloxacin Gatifloxacin SOLUTION/ DROPS OPHTHALMIC 20131001 ANDA ANDA202653 Lupin Pharmaceuticals, Inc. GATIFLOXACIN 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68180-440_660825a1-8953-40d5-a6b4-649fa0fae6ce 68180-440 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20170801 ANDA ANDA065234 Lupin Pharmaceuticals, Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-441_660825a1-8953-40d5-a6b4-649fa0fae6ce 68180-441 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20170801 ANDA ANDA065234 Lupin Pharmaceuticals, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-445_26e189bb-5d31-45c8-8edc-0c85b44cc64c 68180-445 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-446_26e189bb-5d31-45c8-8edc-0c85b44cc64c 68180-446 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-447_26e189bb-5d31-45c8-8edc-0c85b44cc64c 68180-447 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-448_26e189bb-5d31-45c8-8edc-0c85b44cc64c 68180-448 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-449_26e189bb-5d31-45c8-8edc-0c85b44cc64c 68180-449 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-450_26e189bb-5d31-45c8-8edc-0c85b44cc64c 68180-450 HUMAN PRESCRIPTION DRUG Quetiapine fumarate quetiapine fumarate TABLET ORAL 20120327 ANDA ANDA201109 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-464_6cf24650-6436-4868-9c54-3797a029727b 68180-464 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20151202 ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-465_6cf24650-6436-4868-9c54-3797a029727b 68180-465 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20151202 ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-467_27510df9-2eea-4382-8335-0e794a27a59a 68180-467 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Lupin Pharmaceuticals, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-468_27510df9-2eea-4382-8335-0e794a27a59a 68180-468 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Lupin Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-469_27510df9-2eea-4382-8335-0e794a27a59a 68180-469 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Lupin Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-478_6cf24650-6436-4868-9c54-3797a029727b 68180-478 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070612 ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-479_6cf24650-6436-4868-9c54-3797a029727b 68180-479 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070614 ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-480_6cf24650-6436-4868-9c54-3797a029727b 68180-480 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20151123 ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-481_6cf24650-6436-4868-9c54-3797a029727b 68180-481 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20151123 ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-482_6cf24650-6436-4868-9c54-3797a029727b 68180-482 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20090714 ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-485_69a8f532-c1ef-4970-9f1d-5650cad55c39 68180-485 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080724 ANDA ANDA077917 Lupin Pharmaceuticals, Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-486_69a8f532-c1ef-4970-9f1d-5650cad55c39 68180-486 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080724 ANDA ANDA077917 Lupin Pharmaceuticals, Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-487_69a8f532-c1ef-4970-9f1d-5650cad55c39 68180-487 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080724 ANDA ANDA077917 Lupin Pharmaceuticals, Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-488_69a8f532-c1ef-4970-9f1d-5650cad55c39 68180-488 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20080724 ANDA ANDA077917 Lupin Pharmaceuticals, Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68180-490_38227aca-9f9d-4452-ba2b-305abaa1c020 68180-490 HUMAN PRESCRIPTION DRUG Repaglinide and Metformin Hydrochloride Repaglinide and Metformin Hydrochloride TABLET ORAL 20151210 ANDA ANDA200624 Lupin Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE; REPAGLINIDE 500; 1 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 68180-491_38227aca-9f9d-4452-ba2b-305abaa1c020 68180-491 HUMAN PRESCRIPTION DRUG Repaglinide and Metformin Hydrochloride Repaglinide and Metformin Hydrochloride TABLET ORAL 20151210 ANDA ANDA200624 Lupin Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE; REPAGLINIDE 500; 2 mg/1; mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient],Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 68180-501_4c958202-f669-4a95-a1c7-7d822c8c6e22 68180-501 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060719 ANDA ANDA077944 Lupin Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68180-502_4c958202-f669-4a95-a1c7-7d822c8c6e22 68180-502 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060719 ANDA ANDA077944 Lupin Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68180-512_42ab2831-b778-43d5-ae05-853d82ab0cf8 68180-512 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-513_42ab2831-b778-43d5-ae05-853d82ab0cf8 68180-513 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-514_42ab2831-b778-43d5-ae05-853d82ab0cf8 68180-514 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 20191031 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-515_42ab2831-b778-43d5-ae05-853d82ab0cf8 68180-515 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 20191031 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-516_42ab2831-b778-43d5-ae05-853d82ab0cf8 68180-516 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 20191031 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-517_42ab2831-b778-43d5-ae05-853d82ab0cf8 68180-517 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-518_af83fd80-323e-45c6-9ec0-df1845293bed 68180-518 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20061004 ANDA ANDA077912 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-519_af83fd80-323e-45c6-9ec0-df1845293bed 68180-519 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-520_af83fd80-323e-45c6-9ec0-df1845293bed 68180-520 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 Lupin Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-527_3bfe818b-5567-4e5d-8204-1db3190c7169 68180-527 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE TABLET ORAL 20151221 ANDA ANDA202782 Lupin Pharmaceuticals, Inc. DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68180-536_9024ec11-21d0-4a58-9431-43fea37db61b 68180-536 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate LOTION TOPICAL 20180130 ANDA ANDA209147 Lupin Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .05 g/100mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 68180-538_33ce0116-5579-4232-9f31-92edbbe2b656 68180-538 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20160601 ANDA ANDA204132 Lupin Pharmaceuticals, Inc. DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68180-554_528608b0-1210-4dd7-b478-9e5926e678a8 68180-554 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20140801 ANDA ANDA077690 Lupin Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-556_528608b0-1210-4dd7-b478-9e5926e678a8 68180-556 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070226 ANDA ANDA077690 Lupin Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-557_528608b0-1210-4dd7-b478-9e5926e678a8 68180-557 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070226 ANDA ANDA077690 Lupin Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-558_528608b0-1210-4dd7-b478-9e5926e678a8 68180-558 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20070226 ANDA ANDA077690 Lupin Pharmaceuticals, Inc. QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-560_d7128c5d-b0de-4cdb-b17e-a6e91c558f30 68180-560 HUMAN PRESCRIPTION DRUG QUININE SULFATE QUININE SULFATE CAPSULE ORAL 20150804 ANDA ANDA203112 Lupin Pharmaceuticals, Inc. QUININE SULFATE 324 mg/1 Antimalarial [EPC] N 20181231 68180-566_5694dfc5-e7e8-4a6e-88d7-11e4b4b30fe3 68180-566 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070611 ANDA ANDA077522 Lupin Pharmaceuticals, Inc. TRANDOLAPRIL 1 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-567_5694dfc5-e7e8-4a6e-88d7-11e4b4b30fe3 68180-567 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070611 ANDA ANDA077522 Lupin Pharmaceuticals, Inc. TRANDOLAPRIL 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-568_5694dfc5-e7e8-4a6e-88d7-11e4b4b30fe3 68180-568 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070611 ANDA ANDA077522 Lupin Pharmaceuticals, Inc. TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-569_f3278c87-5810-448f-854c-e21dfdcafe09 68180-569 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161128 ANDA ANDA200751 Lupin Pharmaceuticals, Inc. ARMODAFINIL 50 mg/1 N 20181231 68180-571_f3278c87-5810-448f-854c-e21dfdcafe09 68180-571 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161128 ANDA ANDA200751 Lupin Pharmaceuticals, Inc. ARMODAFINIL 150 mg/1 N 20181231 68180-572_f3278c87-5810-448f-854c-e21dfdcafe09 68180-572 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161128 ANDA ANDA200751 Lupin Pharmaceuticals, Inc. ARMODAFINIL 200 mg/1 N 20181231 68180-573_f3278c87-5810-448f-854c-e21dfdcafe09 68180-573 HUMAN PRESCRIPTION DRUG Armodafinil Armodafinil TABLET ORAL 20161128 ANDA ANDA200751 Lupin Pharmaceuticals, Inc. ARMODAFINIL 250 mg/1 N 20181231 68180-588_9ba7c29e-e525-41c9-8488-9a7b1800cde7 68180-588 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 Lupin Pharmaceuticals, Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-589_9ba7c29e-e525-41c9-8488-9a7b1800cde7 68180-589 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 Lupin Pharmaceuticals, Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-590_9ba7c29e-e525-41c9-8488-9a7b1800cde7 68180-590 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 Lupin Pharmaceuticals, Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-591_9ba7c29e-e525-41c9-8488-9a7b1800cde7 68180-591 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080610 ANDA ANDA077626 Lupin Pharmaceuticals, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-592_9313d422-1ace-4d0d-9049-4191f9358b33 68180-592 HUMAN PRESCRIPTION DRUG Desvenlafaxine Succinate Desvenlafaxine Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204172 Lupin Pharmaceuticals, Inc. DESVENLAFAXINE SUCCINATE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 68180-593_9313d422-1ace-4d0d-9049-4191f9358b33 68180-593 HUMAN PRESCRIPTION DRUG Desvenlafaxine Succinate Desvenlafaxine Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170301 ANDA ANDA204172 Lupin Pharmaceuticals, Inc. DESVENLAFAXINE SUCCINATE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20191231 68180-599_db2daa25-273f-4175-ba0b-4c61c86615ce 68180-599 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141210 NDA AUTHORIZED GENERIC NDA020998 Lupin Pharmaceuticals, Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68180-602_86a45a3b-a934-417d-bc27-6d18fbff5f2d 68180-602 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20150325 ANDA ANDA205217 Lupin Pharmaceuticals, Inc. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68180-603_86a45a3b-a934-417d-bc27-6d18fbff5f2d 68180-603 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20150325 ANDA ANDA205217 Lupin Pharmaceuticals, Inc. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68180-606_7577b9e1-234e-4e08-b183-b00865d13e95 68180-606 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20171225 ANDA ANDA209285 Lupin Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68180-611_a73de6b0-ab47-4e6d-8c32-2002816b4e58 68180-611 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 Lupin Pharmaceuticals, Inc. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-612_58d88a9e-ec77-4c22-b3cc-4b95d7788ba8 68180-612 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170822 ANDA ANDA204203 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-613_58d88a9e-ec77-4c22-b3cc-4b95d7788ba8 68180-613 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170822 ANDA ANDA204203 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-614_58d88a9e-ec77-4c22-b3cc-4b95d7788ba8 68180-614 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170822 ANDA ANDA204203 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-615_58d88a9e-ec77-4c22-b3cc-4b95d7788ba8 68180-615 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170822 ANDA ANDA204203 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-616_58d88a9e-ec77-4c22-b3cc-4b95d7788ba8 68180-616 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170822 ANDA ANDA204203 Lupin Pharmaceuticals, Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 68180-622_a73de6b0-ab47-4e6d-8c32-2002816b4e58 68180-622 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 Lupin Pharmaceuticals, Inc. CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-633_a73de6b0-ab47-4e6d-8c32-2002816b4e58 68180-633 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 Lupin Pharmaceuticals, Inc. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-644_a73de6b0-ab47-4e6d-8c32-2002816b4e58 68180-644 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090601 ANDA ANDA065125 Lupin Pharmaceuticals, Inc. CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-645_72b5036a-d313-486b-84f5-3fbf415bb8d6 68180-645 HUMAN PRESCRIPTION DRUG PAROXETINE PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170306 ANDA ANDA204134 Lupin Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 37.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68180-646_72b5036a-d313-486b-84f5-3fbf415bb8d6 68180-646 HUMAN PRESCRIPTION DRUG PAROXETINE PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170306 ANDA ANDA204134 Lupin Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68180-647_72b5036a-d313-486b-84f5-3fbf415bb8d6 68180-647 HUMAN PRESCRIPTION DRUG PAROXETINE PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170306 ANDA ANDA204134 Lupin Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 12.5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68180-650_4a6a5a37-def0-4a33-a652-73b959b76584 68180-650 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20140414 ANDA ANDA204234 Lupin Pharmaceuticals, Inc. DOXYCYCLINE 50 mg/1 E 20171231 68180-651_4a6a5a37-def0-4a33-a652-73b959b76584 68180-651 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20140414 ANDA ANDA204234 Lupin Pharmaceuticals, Inc. DOXYCYCLINE 75 mg/1 E 20171231 68180-652_4a6a5a37-def0-4a33-a652-73b959b76584 68180-652 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20140414 ANDA ANDA204234 Lupin Pharmaceuticals, Inc. DOXYCYCLINE 100 mg/1 E 20171231 68180-653_0d93ee04-4eea-4d04-b6bb-9e0402db181e 68180-653 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxyclycline hyclate TABLET, COATED ORAL 20171030 ANDA ANDA208818 Lupin Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 75 mg/1 N 20191231 68180-654_0d93ee04-4eea-4d04-b6bb-9e0402db181e 68180-654 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxyclycline hyclate TABLET, COATED ORAL 20171030 ANDA ANDA208818 Lupin Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 150 mg/1 N 20191231 68180-655_d67a35de-7411-435d-8b8e-738b30e10992 68180-655 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20060912 ANDA ANDA065263 Lupin Pharmaceuticals, Inc. CEFTRIAXONE SODIUM 10 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-657_dae89fba-6f6f-4367-9e55-659b7d10a0fe 68180-657 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE FOR SUSPENSION ORAL 20130604 ANDA ANDA201678 Lupin Pharmaceuticals, Inc. DOXYCYCLINE 25 mg/5mL N 20181231 68180-658_3fc5afd7-a046-4b77-9ebe-87cde4f1516e 68180-658 HUMAN PRESCRIPTION DRUG rifampin rifampin CAPSULE ORAL 20131028 ANDA ANDA090034 Lupin Pharmaceuticals, Inc. RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 68180-659_3fc5afd7-a046-4b77-9ebe-87cde4f1516e 68180-659 HUMAN PRESCRIPTION DRUG rifampin rifampin CAPSULE ORAL 20131028 ANDA ANDA090034 Lupin Pharmaceuticals, Inc. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 68180-675_61c4e93b-5433-4279-9a21-de09792c0b41 68180-675 HUMAN PRESCRIPTION DRUG Oseltamivir phosphate Oseltamivir phosphate CAPSULE ORAL 20180125 ANDA ANDA208348 Lupin Pharmaceuticals, Inc. OSELTAMIVIR PHOSPHATE 30 mg/1 N 20191231 68180-676_61c4e93b-5433-4279-9a21-de09792c0b41 68180-676 HUMAN PRESCRIPTION DRUG Oseltamivir phosphate Oseltamivir phosphate CAPSULE ORAL 20180125 ANDA ANDA208348 Lupin Pharmaceuticals, Inc. OSELTAMIVIR PHOSPHATE 45 mg/1 N 20191231 68180-677_61c4e93b-5433-4279-9a21-de09792c0b41 68180-677 HUMAN PRESCRIPTION DRUG Oseltamivir phosphate Oseltamivir phosphate CAPSULE ORAL 20180125 ANDA ANDA208348 Lupin Pharmaceuticals, Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 N 20191231 68180-697_22f31efe-fe67-409c-8055-33d12588cde1 68180-697 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20140818 ANDA ANDA200503 Lupin Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68180-698_22f31efe-fe67-409c-8055-33d12588cde1 68180-698 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20140818 ANDA ANDA200503 Lupin Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68180-699_22f31efe-fe67-409c-8055-33d12588cde1 68180-699 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20140818 ANDA ANDA200503 Lupin Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68180-711_87d34363-b17b-439f-bf91-33e2738aea9e 68180-711 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20070501 ANDA ANDA065264 Lupin Pharmaceuticals, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-722_9c257a43-11dd-483c-b020-e2db17f32a99 68180-722 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 Lupin Pharmaceuticals, Inc. CEFDINIR 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-723_9c257a43-11dd-483c-b020-e2db17f32a99 68180-723 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 Lupin Pharmaceuticals, Inc. CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-724_f060a58e-f443-4abc-8e38-942b1877280b 68180-724 HUMAN PRESCRIPTION DRUG OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET, FILM COATED ORAL 20170901 ANDA ANDA206631 Lupin Pharmaceuticals, Inc. OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-725_f060a58e-f443-4abc-8e38-942b1877280b 68180-725 HUMAN PRESCRIPTION DRUG OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET, FILM COATED ORAL 20170901 ANDA ANDA206631 Lupin Pharmaceuticals, Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-726_f060a58e-f443-4abc-8e38-942b1877280b 68180-726 HUMAN PRESCRIPTION DRUG OLMESARTAN MEDOXOMIL OLMESARTAN MEDOXOMIL TABLET, FILM COATED ORAL 20170901 ANDA ANDA206631 Lupin Pharmaceuticals, Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-750_66a0df18-c569-4b95-9a46-e41d03607ad5 68180-750 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070803 ANDA ANDA078043 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68180-751_66a0df18-c569-4b95-9a46-e41d03607ad5 68180-751 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070803 ANDA ANDA078043 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68180-752_66a0df18-c569-4b95-9a46-e41d03607ad5 68180-752 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070803 ANDA ANDA078043 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68180-755_becc09b4-310a-4cb9-8677-d3933e1413c2 68180-755 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100205 ANDA ANDA078466 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 2.5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68180-756_becc09b4-310a-4cb9-8677-d3933e1413c2 68180-756 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100205 ANDA ANDA078466 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68180-757_becc09b4-310a-4cb9-8677-d3933e1413c2 68180-757 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100205 ANDA ANDA078466 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68180-758_becc09b4-310a-4cb9-8677-d3933e1413c2 68180-758 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20100205 ANDA ANDA078466 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68180-759_becc09b4-310a-4cb9-8677-d3933e1413c2 68180-759 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA078466 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68180-760_becc09b4-310a-4cb9-8677-d3933e1413c2 68180-760 HUMAN PRESCRIPTION DRUG Amlodipine Besylate and Benazepril Hydrochloride Amlodipine Besylate and Benazepril Hydrochloride CAPSULE ORAL 20110705 ANDA ANDA078466 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68180-764_b5a13389-e39e-4825-a6dc-4ba50d432aed 68180-764 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA090245 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-765_b5a13389-e39e-4825-a6dc-4ba50d432aed 68180-765 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA090245 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 160 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-766_b5a13389-e39e-4825-a6dc-4ba50d432aed 68180-766 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA090245 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; VALSARTAN 5; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-767_b5a13389-e39e-4825-a6dc-4ba50d432aed 68180-767 HUMAN PRESCRIPTION DRUG Amlodipine and Valsartan Amlodipine and Valsartan TABLET ORAL 20150330 ANDA ANDA090245 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; VALSARTAN 10; 320 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68180-771_2394bbe4-bf25-4f7a-bc1c-5d435040de3b 68180-771 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150603 ANDA ANDA200797 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68180-772_2394bbe4-bf25-4f7a-bc1c-5d435040de3b 68180-772 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150603 ANDA ANDA200797 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 12.5 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68180-773_2394bbe4-bf25-4f7a-bc1c-5d435040de3b 68180-773 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150603 ANDA ANDA200797 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 5; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68180-774_2394bbe4-bf25-4f7a-bc1c-5d435040de3b 68180-774 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150603 ANDA ANDA200797 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 160; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68180-775_2394bbe4-bf25-4f7a-bc1c-5d435040de3b 68180-775 HUMAN PRESCRIPTION DRUG Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150603 ANDA ANDA200797 Lupin Pharmaceuticals, Inc. AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE 10; 320; 25 mg/1; mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68180-779_78b29c02-5b05-4168-a39a-f3a3300d16da 68180-779 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE Zolpidem Tartrate TABLET, EXTENDED RELEASE ORAL 20140407 ANDA ANDA078970 Lupin Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 68180-780_78b29c02-5b05-4168-a39a-f3a3300d16da 68180-780 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE Zolpidem Tartrate TABLET, EXTENDED RELEASE ORAL 20140407 ANDA ANDA078970 Lupin Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] N 20181231 68180-798_b4332d5f-6114-4f34-87b3-40a6a50c2f8b 68180-798 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20160118 ANDA ANDA203002 Lupin Pharmaceuticals, Inc. POTASSIUM CHLORIDE 8 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68180-799_b4332d5f-6114-4f34-87b3-40a6a50c2f8b 68180-799 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20160118 ANDA ANDA203002 Lupin Pharmaceuticals, Inc. POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68180-811_b5024702-310b-4170-a820-86ba597c4894 68180-811 HUMAN PRESCRIPTION DRUG CEFOTAXIME CEFOTAXIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050527 ANDA ANDA065124 Lupin Pharmaceuticals, Inc. CEFOTAXIME SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-819_b17bd970-46f9-468a-9761-5a98db72aa70 68180-819 HUMAN PRESCRIPTION DRUG Lanthanum Carbonate Lanthanum Carbonate TABLET, CHEWABLE ORAL 20170830 ANDA ANDA090978 Lupin Pharmaceuticals, Inc. LANTHANUM CARBONATE 500 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 68180-820_b17bd970-46f9-468a-9761-5a98db72aa70 68180-820 HUMAN PRESCRIPTION DRUG Lanthanum Carbonate Lanthanum Carbonate TABLET, CHEWABLE ORAL 20170830 ANDA ANDA090978 Lupin Pharmaceuticals, Inc. LANTHANUM CARBONATE 750 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 68180-821_b17bd970-46f9-468a-9761-5a98db72aa70 68180-821 HUMAN PRESCRIPTION DRUG Lanthanum Carbonate Lanthanum Carbonate TABLET, CHEWABLE ORAL 20170830 ANDA ANDA090978 Lupin Pharmaceuticals, Inc. LANTHANUM CARBONATE 1000 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 68180-822_b5024702-310b-4170-a820-86ba597c4894 68180-822 HUMAN PRESCRIPTION DRUG CEFOTAXIME CEFOTAXIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050527 ANDA ANDA065124 Lupin Pharmaceuticals, Inc. CEFOTAXIME SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-827_af0dbf03-0695-4698-bdf9-476bf4c6608c 68180-827 HUMAN PRESCRIPTION DRUG Fyavolv Norethindrone Acetate and Ethinyl Estradiol TABLET, FILM COATED ORAL 20160205 ANDA ANDA204213 Lupin Pharmaceuticals, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .0025; .5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68180-828_af0dbf03-0695-4698-bdf9-476bf4c6608c 68180-828 HUMAN PRESCRIPTION DRUG Fyavolv Norethindrone Acetate and Ethinyl Estradiol TABLET, FILM COATED ORAL 20160205 ANDA ANDA204213 Lupin Pharmaceuticals, Inc. ETHINYL ESTRADIOL; NORETHINDRONE ACETATE .005; 1 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68180-829_32c2d4a8-73e7-4415-9464-6a71ef763246 68180-829 HUMAN PRESCRIPTION DRUG AMABELZ estradiol and norethindrone acetate TABLET ORAL 20161021 ANDA ANDA203339 Lupin Pharmaceuticals, Inc. ESTRADIOL; NORETHINDRONE .5; .1 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68180-830_32c2d4a8-73e7-4415-9464-6a71ef763246 68180-830 HUMAN PRESCRIPTION DRUG AMABELZ estradiol and norethindrone acetate TABLET ORAL 20161021 ANDA ANDA203339 Lupin Pharmaceuticals, Inc. ESTRADIOL; NORETHINDRONE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68180-833_b5024702-310b-4170-a820-86ba597c4894 68180-833 HUMAN PRESCRIPTION DRUG CEFOTAXIME CEFOTAXIME INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20050527 ANDA ANDA065124 Lupin Pharmaceuticals, Inc. CEFOTAXIME SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68180-837_498f6d6c-3ec0-412c-a26b-7b916809c3fa 68180-837 HUMAN PRESCRIPTION DRUG TRI-LO-MARZIA norgestimate and ethinyl estradiol KIT 20160118 ANDA ANDA200541 Lupin Pharmaceuticals, Inc. N 20181231 68180-838_45a02343-f5b6-4c12-aa4d-5bb5516f0100 68180-838 HUMAN PRESCRIPTION DRUG Norgestimate and ethinyl estradiol Norgestimate and ethinyl estradiol KIT 20160718 ANDA ANDA205588 Lupin Pharmaceuticals, Inc. E 20171231 68180-840_04c730c8-629f-4067-b6da-3ddc0796848d 68180-840 HUMAN PRESCRIPTION DRUG Norgestimate and Ethinyl Estradiol Norgestimate and Ethinyl Estradiol KIT 20170123 ANDA ANDA205630 Lupin Pharmaceuticals, Inc. N 20181231 68180-843_f377431d-b61f-4bd9-a46a-effa82a1d67d 68180-843 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol Levonorgestrel and Ethinyl Estradiol KIT 20121024 ANDA ANDA091440 Lupin Pharmaceuticals, Inc. N 20181231 68180-844_a17401bf-d0a1-42e9-8125-180ca90905e4 68180-844 HUMAN PRESCRIPTION DRUG Kurvelo Levonorgestrel and Ethinyl Estradiol KIT 20121026 ANDA ANDA091408 Lupin Pharmaceuticals, Inc. N 20181231 68180-846_f43c433e-2c80-4b47-8c34-99349b8a4ab5 68180-846 HUMAN PRESCRIPTION DRUG Daysee LEVONORGESTREL AND ETHINYL ESTRADIOL KIT 20130410 ANDA ANDA091467 Lupin Pharmaceuticals, Inc. N 20181231 68180-848_5c413810-0fca-4555-94b2-ebaa4e7d2b40 68180-848 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol levonorgestrel and ethinyl estradiol KIT 20111202 ANDA ANDA091674 Lupin Pharmaceuticals, Inc. N 20181231 68180-852_b3115637-7cc5-40e1-b67e-d3e7dd927c3f 68180-852 HUMAN OTC DRUG My Way levonorgestrel TABLET ORAL 20170425 ANDA ANDA201446 Lupin Pharmaceuticals, Inc. LEVONORGESTREL 1.5 mg/1 N 20181231 68180-853_8df2c086-fa37-4c8a-b110-9cbb7e22cdd3 68180-853 HUMAN OTC DRUG Fallback Solo levonorgestrel TABLET ORAL 20140722 ANDA ANDA201446 Lupin Pharmaceuticals, Inc. LEVONORGESTREL 1.5 mg/1 N 20181231 68180-854_b8ad98d9-ec21-4fe1-838f-b3ae04c868a4 68180-854 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol Levonorgestrel and Ethinyl Estradiol KIT 20130320 ANDA ANDA091425 Lupin Pharmaceuticals, Inc. N 20181231 68180-857_e988e15c-4e59-4367-9546-043b45c5e2db 68180-857 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol Levonorgestrel and Ethinyl Estradiol KIT 20151203 ANDA ANDA200248 Lupin Pharmaceuticals, Inc. N 20181231 68180-860_f70a953d-38d6-4817-bb3c-2383b6fc6651 68180-860 HUMAN PRESCRIPTION DRUG FAYOSIM LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL KIT 20170403 ANDA ANDA205943 Lupin Pharmaceuticals, Inc. N 20181231 68180-864_c2f9adac-5c1d-436d-ba7f-59d0dfd2ee0a 68180-864 HUMAN PRESCRIPTION DRUG Blisovi 24 Fe norethindrone acetate and ethinyl estradiol KIT 20151125 ANDA ANDA091398 Lupin Pharmaceuticals, Inc. N 20181231 68180-865_d261d486-82ad-4e2b-9abb-a263a57d6b94 68180-865 HUMAN PRESCRIPTION DRUG Blisovi Fe 1/20 norethindrone acetate and ethinyl estradiol KIT 20151208 ANDA ANDA201584 Lupin Pharmaceuticals, Inc. N 20181231 68180-866_be43ae36-15e0-478f-af00-73bcece627f6 68180-866 HUMAN PRESCRIPTION DRUG Blisovi Fe 1.5/30 Norethindrone Acetate and Ethinyl Estradiol KIT 20160105 ANDA ANDA201585 Lupin Pharmaceuticals, Inc. N 20181231 68180-873_0abc2fa7-1696-48b4-9602-d1d2c27361e6 68180-873 HUMAN PRESCRIPTION DRUG WYMZYA Fe NORETHINDRONE AND ETHINYL ESTRADIOL KIT 20161205 ANDA ANDA091332 Lupin Pharmaceuticals, Inc. N 20181231 68180-875_17fd9539-c91b-42c1-ae80-8313aa3a1029 68180-875 HUMAN PRESCRIPTION DRUG Vyfemla norethindrone and ethinyl estradiol KIT 20131223 ANDA ANDA201886 Lupin Pharmaceuticals, Inc. N 20181231 68180-876_00cdca18-5cfd-44c8-9c92-732799f86464 68180-876 HUMAN PRESCRIPTION DRUG NORETHINDRONE NORETHINDRONE TABLET ORAL 20111110 ANDA ANDA091325 Lupin Pharmaceuticals, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68180-877_67a1856e-7887-4cf2-a209-b8f50a9f59cf 68180-877 HUMAN PRESCRIPTION DRUG Jencycla norethindrone TABLET ORAL 20130508 ANDA ANDA091323 Lupin Pharmaceuticals, Inc. NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68180-879_444808a7-c302-452d-b547-3f99ab62e873 68180-879 HUMAN PRESCRIPTION DRUG Bekyree desogestrel and ethinyl estradiol and ethinyl estradiol KIT 20180120 ANDA ANDA202226 Lupin Pharmaceuticals, Inc. N 20191231 68180-880_444808a7-c302-452d-b547-3f99ab62e873 68180-880 HUMAN PRESCRIPTION DRUG Bekyree desogestrel and ethinyl estradiol and ethinyl estradiol KIT 20151026 20190801 ANDA ANDA202226 Lupin Pharmaceuticals, Inc. N 20191231 68180-882_e915dde3-6476-4024-a6c6-e733178e2750 68180-882 HUMAN PRESCRIPTION DRUG ENSKYCE desogestrel and ethinyl estradiol KIT 20130507 20201101 ANDA ANDA201887 Lupin Pharmaceuticals, Inc. N 20191231 68180-886_d4669c35-7732-487b-b1a5-9d6ae8543409 68180-886 HUMAN PRESCRIPTION DRUG Nikki drospirenone and ethinyl estradiol KIT 20140730 ANDA ANDA201661 Lupin Pharmaceuticals, Inc. N 20191231 68180-891_e915dde3-6476-4024-a6c6-e733178e2750 68180-891 HUMAN PRESCRIPTION DRUG ENSKYCE desogestrel and ethinyl estradiol KIT 20180120 ANDA ANDA201887 Lupin Pharmaceuticals, Inc. N 20191231 68180-892_b6744a9f-7173-423c-a62a-d72458838e18 68180-892 HUMAN PRESCRIPTION DRUG PIRMELLA 7/7/7 NORETHINDRONE AND ETHINYL ESTRADIOL KIT 20130515 ANDA ANDA201510 Lupin Pharmaceuticals, Inc. N 20181231 68180-893_b6744a9f-7173-423c-a62a-d72458838e18 68180-893 HUMAN PRESCRIPTION DRUG PIRMELLA 1/35 NORETHINDRONE AND ETHINYL ESTRADIOL KIT 20130621 ANDA ANDA201512 Lupin Pharmaceuticals, Inc. N 20181231 68180-897_f704dd21-68d1-4697-b07f-4e07a8a9c29c 68180-897 HUMAN PRESCRIPTION DRUG Norethindrone and Ethinyl Estradiol and Ferrous Fumarate Norethindrone and Ethinyl Estradiol KIT 20111004 NDA AUTHORIZED GENERIC NDA021490 Lupin Pharmaceuticals, Inc. E 20171231 68180-898_f9cfdf35-7cd0-4984-99e4-0e4a7df91b4e 68180-898 HUMAN PRESCRIPTION DRUG WYMZYA FE norethindrone and ethinyl estradiol, and ferrous fumarate KIT 20121219 NDA AUTHORIZED GENERIC NDA021490 Lupin Pharmaceuticals, Inc. E 20171231 68180-899_e4a8d988-7070-405e-8972-531ebc7636bb 68180-899 HUMAN PRESCRIPTION DRUG WYMZYA FE norethindrone and ethinyl estradiol, and ferrous fumarate KIT 20121219 NDA AUTHORIZED GENERIC NDA021490 Lupin Pharmaceuticals, Inc. N 20181231 68180-902_bf3318af-a5da-4666-b6ed-55d7f7f4f160 68180-902 HUMAN PRESCRIPTION DRUG DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE AND ETHINYL ESTRADIOL KIT 20121231 ANDA ANDA201663 Lupin Pharmaceuticals, Inc. N 20181231 68180-903_678eface-a18a-42a1-907e-1cf57b6c8c9e 68180-903 HUMAN PRESCRIPTION DRUG Kaitlib Fe norethindrone and ethinyl estradiol KIT 20151217 ANDA ANDA203448 Lupin Pharmaceuticals, Inc. N 20181231 68180-911_0d96cc74-bc84-43f7-942d-59fa8533c819 68180-911 HUMAN PRESCRIPTION DRUG Mibelas 24 Fe NORETHINDRONE ACETATE, ETHINYL ESTRADIOL AND FERROUS FUMARATE KIT 20170125 ANDA ANDA206287 Lupin Pharmaceuticals, Inc. N 20181231 68180-943_9f2d720d-817d-435f-87a2-8d7594732923 68180-943 HUMAN PRESCRIPTION DRUG Testosterone Testosterone SOLUTION TOPICAL 20180101 ANDA ANDA208061 Lupin Pharmaceuticals, Inc. TESTOSTERONE 30 mg/1.5mL Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 68180-946_d9b83e90-dd27-44c5-b6cf-70ae4aa96b5e 68180-946 HUMAN PRESCRIPTION DRUG DESOXIMETASONE DESOXIMETASONE OINTMENT TOPICAL 20170510 ANDA ANDA208104 Lupin Pharmaceuticals, Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68180-948_396a9b3c-a42a-4e72-95d4-0c8f60fee560 68180-948 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20170425 ANDA ANDA208044 Lupin Pharmaceuticals, Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68180-949_ec2391ae-d373-44ca-980a-1ebe815f2c84 68180-949 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 20170620 ANDA ANDA208163 Lupin Pharmaceuticals, Inc. DESOXIMETASONE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68180-950_f9ff603e-dbe6-4496-8bf3-9a5f2997a7d3 68180-950 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone CREAM TOPICAL 20170620 ANDA ANDA208164 Lupin Pharmaceuticals, Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68180-980_42ab2831-b778-43d5-ae05-853d82ab0cf8 68180-980 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170307 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-981_42ab2831-b778-43d5-ae05-853d82ab0cf8 68180-981 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170307 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68180-982_42ab2831-b778-43d5-ae05-853d82ab0cf8 68180-982 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170307 ANDA ANDA077321 Lupin Pharmaceuticals, Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68183-116_6154c64d-ad87-ab38-e053-2a91aa0a2e53 68183-116 HUMAN OTC DRUG Povidone Iodine Povidone Iodine SWAB TOPICAL 20151014 UNAPPROVED DRUG OTHER Custom Kits Company Inc POVIDONE-IODINE 10 mg/mL N 20181231 68183-117_615472c5-cfb5-22fb-e053-2991aa0ad0d9 68183-117 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol CLOTH TOPICAL 20151015 OTC MONOGRAPH NOT FINAL part333A Custom Kits Company Inc ISOPROPYL ALCOHOL .7 mL/.7mL N 20181231 68183-118_61546e55-1381-1648-e053-2991aa0a35a0 68183-118 HUMAN OTC DRUG Medicaine Sting and Bite Benzocaine SWAB TOPICAL 20151014 UNAPPROVED DRUG OTHER Custom Kits Company Inc BENZOCAINE .12 g/g N 20181231 68183-119_61546e55-1372-1648-e053-2991aa0a35a0 68183-119 HUMAN OTC DRUG Povidone Iodine Prep Pads Povidone Iodine Prep Pads CLOTH TOPICAL 20151021 OTC MONOGRAPH NOT FINAL part356 Custom Kits Company Inc POVIDONE-IODINE 10 g/mL N 20181231 68183-120_615453a8-ae7d-1b4a-e053-2a91aa0afcd4 68183-120 HUMAN OTC DRUG Antiseptic Towelettes Benzalkonium Chloride CLOTH TOPICAL 20151022 OTC MONOGRAPH NOT FINAL part333A Custom Kits Company Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 68196-001_4c790679-046e-48f6-8565-ed2c1d850e0c 68196-001 HUMAN OTC DRUG members mark nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20150624 ANDA ANDA078547 Sam's West Inc NICOTINE 2 mg/1 N 20181231 68196-002_41933396-583d-4d5b-b0ef-7ba2b8512c92 68196-002 HUMAN OTC DRUG Members Mark Diaper Rash Zinc Oxide CREAM TOPICAL 20170807 OTC MONOGRAPH NOT FINAL part352 Sams West Inc ZINC OXIDE 13 g/100g N 20181231 68196-003_384fe585-b214-4642-98c3-60b03c891ed9 68196-003 HUMAN OTC DRUG members mark nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20150528 ANDA ANDA076779 Sam's West Inc NICOTINE 4 mg/1 N 20181231 68196-004_2ec0d288-ea2f-4d55-b5d4-3fcc11f4a2e8 68196-004 HUMAN OTC DRUG members mark nicotine Nicotine polacrilex GUM, CHEWING ORAL 20150807 ANDA ANDA078546 Sam's West Inc NICOTINE 4 mg/1 N 20181231 68196-005_0824012a-a3ef-4cae-88ca-145d4c905400 68196-005 HUMAN OTC DRUG members mark ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20150518 ANDA ANDA072096 Sam's West Inc IBUPROFEN 200 mg/1 N 20181231 68196-010_5ddd77db-05ab-4d10-b24e-93d456d50bf5 68196-010 HUMAN OTC DRUG Nicotine nicotine polacrilex GUM, CHEWING ORAL 20171016 ANDA ANDA074507 Sam's West, Inc. NICOTINE 2 mg/1 N 20181231 68196-011_5ddd77db-05ab-4d10-b24e-93d456d50bf5 68196-011 HUMAN OTC DRUG Nicotine nicotine polacrilex GUM, CHEWING ORAL 20171016 ANDA ANDA074707 Sam's West, Inc. NICOTINE 4 mg/1 N 20181231 68196-012_bb8ec4c2-7f1a-4069-9677-8bf645d18e32 68196-012 HUMAN OTC DRUG Members Mark Nicotine Nicotine polacrilex GUM, CHEWING ORAL 20170406 ANDA ANDA206394 Sam's West Inc NICOTINE 2 mg/1 N 20181231 68196-013_0b857f45-e146-48b4-af90-fe32448aa028 68196-013 HUMAN OTC DRUG Nicotine COATED ice mint nicotine polacrilex GUM, CHEWING ORAL 20171016 ANDA ANDA204794 Sam's West, Inc. NICOTINE 2 mg/1 N 20181231 68196-014_0b857f45-e146-48b4-af90-fe32448aa028 68196-014 HUMAN OTC DRUG Nicotine COATED ice mint nicotine polacrilex GUM, CHEWING ORAL 20171016 ANDA ANDA204833 Sam's West, Inc. NICOTINE 4 mg/1 N 20181231 68196-015_fc34ddc2-f380-4470-8cea-3c9040042661 68196-015 HUMAN OTC DRUG Nicotine Coated Fruit Flavor nicotine polacrilex GUM, CHEWING ORAL 20171016 ANDA ANDA079044 Sam's West, Inc. NICOTINE 2 mg/1 N 20181231 68196-016_fc34ddc2-f380-4470-8cea-3c9040042661 68196-016 HUMAN OTC DRUG Nicotine Coated Fruit Flavor nicotine polacrilex GUM, CHEWING ORAL 20171016 ANDA ANDA079038 Sam's West, Inc. NICOTINE 4 mg/1 N 20181231 68196-019_b7306f51-ece9-411c-a4da-e5cfb136408b 68196-019 HUMAN OTC DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130330 ANDA ANDA202727 SIMPLY RIGHT (Sam's West, Inc.) LANSOPRAZOLE 15 mg/1 N 20181231 68196-020_ed27daf1-4401-44bf-85ef-c7e05ad125ea 68196-020 HUMAN OTC DRUG members mark lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20150716 ANDA ANDA202319 Sam's West Inc LANSOPRAZOLE 15 mg/1 N 20181231 68196-023_58cae915-5756-4987-8860-534e473dd399 68196-023 HUMAN OTC DRUG members mark minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20150924 ANDA ANDA091344 Sam's West Inc MINOXIDIL 5 g/100g N 20181231 68196-029_d43d56ec-fd2c-433a-9166-be10144f3ba1 68196-029 HUMAN OTC DRUG members mark nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20050930 ANDA ANDA076775 Sam's West Inc NICOTINE 2 mg/1 N 20181231 68196-030_fa6f14a6-4272-4741-a3aa-024b121ad910 68196-030 HUMAN OTC DRUG Lansoprazole lansoprazole delayed release CAPSULE, DELAYED RELEASE ORAL 20170706 ANDA ANDA203187 Sam's West, Inc. LANSOPRAZOLE 15 mg/1 N 20181231 68196-061_bb4358af-c4b6-47d5-b471-f89416cfd964 68196-061 HUMAN OTC DRUG members mark famotidine Famotidine TABLET ORAL 20060928 ANDA ANDA077351 Sam's West Inc FAMOTIDINE 20 mg/1 N 20181231 68196-072_33c47da9-24c8-442e-b4bd-04f68761d435 68196-072 HUMAN OTC DRUG Guaifenesin Extended Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20171031 NDA NDA021282 SAM'S WEST INC GUAIFENESIN 1200 mg/1 N 20191231 68196-073_c78f70c1-fb03-479e-a6f2-19ad638bc400 68196-073 HUMAN OTC DRUG Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20171031 NDA NDA021620 SAM'S WEST INC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20191231 68196-082_48fc70d3-fe2e-4377-a4d4-6173a2a486d9 68196-082 HUMAN OTC DRUG members mark nicotine Nicotine Polacrilex LOZENGE ORAL 20150729 ANDA ANDA077007 Sam's West Inc NICOTINE 2 mg/1 N 20181231 68196-102_6b3ea903-4521-4a60-9d5c-fac8a63ae68c 68196-102 HUMAN OTC DRUG SIMPLY RIGHT childrens cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20110908 ANDA ANDA090182 Sam's West Inc CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 68196-110_4ee40e37-a0a8-4d89-a305-84f998d041b7 68196-110 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20111030 OTC MONOGRAPH NOT FINAL part334 SIMPLY RIGHT (Sam's West, Inc.) DOCUSATE SODIUM 100 mg/1 N 20181231 68196-117_71fe86cd-c59e-4577-8498-9a5867da2e9d 68196-117 HUMAN OTC DRUG Simply Right Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20140529 ANDA ANDA202319 Sam's West Inc LANSOPRAZOLE 15 mg/1 N 20181231 68196-140_243b4126-e3dd-4056-ba8a-1ed691248ee6 68196-140 HUMAN OTC DRUG ANTIBACTERIAL HAND SP WITH LIGHT MOISTURIZERS TRICLOSAN LIQUID TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN .115 L/100L N 20181231 68196-141_72bb3a24-bca4-4921-92af-cb257bc31a27 68196-141 HUMAN OTC DRUG ANTIBACTERIAL HAND SP WITH LIGHT MOISTURIZERS REFILL TRICLOSAN LIQUID TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN .115 L/100L N 20181231 68196-142_afaa8535-ca51-4409-87c1-70e2e78e64db 68196-142 HUMAN OTC DRUG ANTIBACTERIAL LIGHT MOISTURIZERS TRICLOSAN LIQUID TOPICAL 20110606 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN .115 L/100L N 20181231 68196-143_4b587026-1a44-4960-8c27-fdb5415914e9 68196-143 HUMAN OTC DRUG ANTIBACTERIAL LIGHT MOISTURIZERS REFILL TRICLOSAN LIQUID TOPICAL 20110606 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN .115 L/100L N 20181231 68196-144_34c575c6-c900-4699-8605-7d25b967faae 68196-144 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20121024 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN 1.15 mg/mL N 20181231 68196-145_394ec837-7cc2-4dd6-a463-6ba1d565c8e0 68196-145 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20121025 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN 1.15 mg/mL N 20181231 68196-146_a2308485-181b-4423-b3de-e7b8c4e35994 68196-146 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE TRICLOSAN LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN 1.15 mg/mL N 20181231 68196-147_6bd8b2d8-c921-410f-be43-a324b8869355 68196-147 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE TRICLOSAN LIQUID TOPICAL 20130703 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN 1.15 mg/mL N 20181231 68196-149_543742ba-7e3d-4067-bf5e-fbc380e3ec22 68196-149 HUMAN OTC DRUG SIMPLY RIGHT HAND BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131223 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC BENZALKONIUM CHLORIDE 1.5 mg/mL N 20181231 68196-157_0af1a28f-81ac-4a9c-8b11-b2759ed81eea 68196-157 HUMAN OTC DRUG Aspirin regular strength aspirin TABLET ORAL 19960210 20190623 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc ASPIRIN 325 mg/1 N 20181231 68196-170_7aa51d27-9b90-4090-b7c2-31cfd99fc7be 68196-170 HUMAN OTC DRUG members mark nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20051005 ANDA ANDA076789 Sam's West Inc NICOTINE 4 mg/1 N 20181231 68196-194_f039c92f-9ecb-44c4-8142-d1cf37bb1da0 68196-194 HUMAN OTC DRUG Nicotine transdermal system nicotine PATCH, EXTENDED RELEASE TRANSDERMAL 20120302 NDA NDA020165 Sam's West Inc NICOTINE 21 mg/24h N 20181231 68196-199_89c6be87-0030-4437-a77f-6c9033006769 68196-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20150531 ANDA ANDA078682 Sam's West, Inc IBUPROFEN 200 mg/1 N 20181231 68196-213_95261ac0-1c66-45c4-9cc9-eceddc52f656 68196-213 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130430 OTC MONOGRAPH FINAL part341 SIMPLY RIGHT (Sam's West, Inc.) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 68196-236_d2b0f5b6-19b1-48a0-aa0b-2f8a901dfb78 68196-236 HUMAN OTC DRUG Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20140201 OTC MONOGRAPH FINAL part341 Sam's West, Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 68196-238_b2d11dc1-c266-43ca-8d9d-b8dc58dccfa0 68196-238 HUMAN OTC DRUG Stool Softener DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20150531 OTC MONOGRAPH NOT FINAL part334 Sam's West, Inc DOCUSATE SODIUM 100 mg/1 N 20181231 68196-268_234537fa-88f1-45e3-a7e0-ae9da0175924 68196-268 HUMAN OTC DRUG Hydrogen Peroxide 3 Percent Hydrogen Peroxide LIQUID TOPICAL 20141130 OTC MONOGRAPH NOT FINAL part356 Sam's West, Inc HYDROGEN PEROXIDE 2.65 mL/100mL N 20181231 68196-275_a25cae3c-5f4c-4ecf-8095-a50a40ef7d20 68196-275 HUMAN OTC DRUG Isopropyl Alcohol 70 Percent Isopropyl Alcohol LIQUID TOPICAL 20141130 OTC MONOGRAPH NOT FINAL part333A Sam's West, Inc ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 68196-277_edd6d1a8-1b53-4c33-81de-8d02425fef50 68196-277 HUMAN OTC DRUG Isopropyl alcohol 91 percent Isopropyl alcohol LIQUID TOPICAL 20141130 OTC MONOGRAPH NOT FINAL part333A Sam's West, Inc ISOPROPYL ALCOHOL 91 mL/100mL N 20181231 68196-294_783acab1-e4c4-44d7-ab6e-80fe57644678 68196-294 HUMAN OTC DRUG simply right minoxidil Minoxidil AEROSOL, FOAM TOPICAL 20120301 ANDA ANDA091344 Sam's West Inc MINOXIDIL 5 g/100g N 20181231 68196-299_f520c96b-7248-4918-ad9f-a10c826402cd 68196-299 HUMAN OTC DRUG simply right famotidine Famotidine TABLET ORAL 20120126 ANDA ANDA077351 Sam's West Inc FAMOTIDINE 20 mg/1 N 20181231 68196-306_b7cf2f53-bb7c-46c4-a884-4eb51054bd5b 68196-306 HUMAN OTC DRUG Members Mark clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091008 ANDA ANDA090685 Sam's West Inc POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 68196-309_0ea1d300-d77a-4262-b74c-583455606a2c 68196-309 HUMAN OTC DRUG members mark nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170405 ANDA ANDA206393 Sam's West Inc NICOTINE 4 mg/1 N 20181231 68196-324_55dfe27c-ed47-4e30-9f1e-4a50af5f94b5 68196-324 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE DAILY MOISTURIZING DIMETHICONE LOTION TOPICAL 20130206 OTC MONOGRAPH FINAL part347 SAM'S WEST INC. DIMETHICONE 13 mg/mL N 20181231 68196-324_571d8f2d-71d0-4c6f-acf2-7ce46a4160d6 68196-324 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE DAILY MOISTURIZING DIMETHICONE LOTION TOPICAL 20130206 OTC MONOGRAPH FINAL part347 SAM'S WEST INC. DIMETHICONE 13 mg/mL N 20181231 68196-325_a3370ff6-00d6-4083-8345-3d5ff3549a40 68196-325 HUMAN OTC DRUG Members Mark mucus relief ER Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160901 ANDA ANDA091009 Sam's West Inc GUAIFENESIN 1200 mg/1 N 20181231 68196-329_3490a89b-dbf5-4a35-bbd6-a117239c42a0 68196-329 HUMAN OTC DRUG diphenhydramine Diphenhydramine HCl CAPSULE, COATED ORAL 19900302 20180402 OTC MONOGRAPH FINAL part341 Sam's West Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 68196-344_b5c67899-3c5c-4dc4-9968-5dce343e0532 68196-344 HUMAN OTC DRUG simply right nicotine Nicotine Polacrilex LOZENGE ORAL 20070907 ANDA ANDA077007 Sam's West Inc NICOTINE 2 mg/1 N 20181231 68196-368_2f2dbf4e-0019-4912-82f5-c33adf7f4f7e 68196-368 HUMAN OTC DRUG members mark naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20070529 ANDA ANDA074661 Sam's West Inc NAPROXEN SODIUM 220 mg/1 N 20181231 68196-370_4d1cfbd1-571f-4214-9610-80ed46572f10 68196-370 HUMAN OTC DRUG Hand Sanitizer Ethyl alcohol GEL TOPICAL 20170817 OTC MONOGRAPH NOT FINAL part333A Sam's West Inc. ALCOHOL 700 mg/mL N 20181231 68196-375_fce87874-7c3c-4ce3-9571-f995cc7e686c 68196-375 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl TABLET ORAL 20050503 20180702 ANDA ANDA076497 Sam's West Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 E 20171231 68196-401_82693da1-bd56-418a-a130-9d7487ebcdc4 68196-401 HUMAN OTC DRUG Members Mark Minoxidil Minoxidil SOLUTION TOPICAL 20091110 ANDA ANDA075598 Sam's West Inc MINOXIDIL 3 g/60mL N 20181231 68196-427_69c9cf12-fc4a-445b-be52-daaba8269518 68196-427 HUMAN OTC DRUG MEMBERS MARK GENTLE DANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20160316 OTC MONOGRAPH FINAL part358H SAMS WEST INC PYRITHIONE ZINC 10 mg/mL N 20181231 68196-456_95f2f947-5a75-43b2-b70b-9c46b6e883b7 68196-456 HUMAN OTC DRUG simply right nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20120126 ANDA ANDA076777 Sam's West Inc NICOTINE 2 mg/1 N 20181231 68196-458_916708bf-5cd8-4424-a1b6-4b5be4acddf6 68196-458 HUMAN OTC DRUG Members mark cetirizine Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20080324 ANDA ANDA078336 Sam's West Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 68196-463_da81022f-5c0c-437c-96f6-a4eb67d7dbc3 68196-463 HUMAN OTC DRUG simply right arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120128 ANDA ANDA075077 Sam's West Inc ACETAMINOPHEN 650 mg/1 N 20181231 68196-469_0d444bfc-c5f4-4201-b915-8892e87f2f0a 68196-469 HUMAN OTC DRUG members mark hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20170622 ANDA ANDA091344 Sam's West Inc MINOXIDIL 5 g/100g N 20181231 68196-484_30409e51-b2e7-4cf4-9e39-23a1b7e77797 68196-484 HUMAN OTC DRUG Members Mark Acetaminophen Acetaminophen TABLET ORAL 20100208 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc ACETAMINOPHEN 500 mg/1 N 20181231 68196-499_61a2256b-e085-4b6a-a1a8-43e05a3d2b95 68196-499 HUMAN OTC DRUG simply right naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20140212 ANDA ANDA074661 Sam's West Inc NAPROXEN SODIUM 220 mg/1 N 20181231 68196-501_cab275e9-712d-46ce-8318-55964ab3dbb8 68196-501 HUMAN OTC DRUG members mark nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20150528 ANDA ANDA076777 Sam's West Inc NICOTINE 2 mg/1 N 20181231 68196-532_d7a65c20-fef6-47af-a6bd-0f95fa0a78f5 68196-532 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20051222 20180803 OTC MONOGRAPH FINAL part341 Sam's West Inc GUAIFENESIN 400 mg/1 E 20171231 68196-544_33ec1748-7146-4ee0-9a54-2986a7e62b3e 68196-544 HUMAN OTC DRUG members mark arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20050831 ANDA ANDA075077 Sam's West Inc ACETAMINOPHEN 650 mg/1 N 20181231 68196-556_7dd1670b-483a-4697-8b10-b516529034fe 68196-556 HUMAN OTC DRUG acetaminophen pm extra strength acetaminophen, diphenhydramine HCl TABLET ORAL 20071217 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 68196-571_01ee0f64-8ea5-4727-a681-380e240cc844 68196-571 HUMAN OTC DRUG members mark fexofenadine fexofenadine hydrochloride TABLET, FILM COATED ORAL 20110414 ANDA ANDA076447 Sam's West Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 68196-600_f1affba1-7b84-4aed-942e-709d6fc48492 68196-600 HUMAN OTC DRUG aspirin low strength adult Aspirin TABLET, COATED ORAL 20080212 20180619 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc ASPIRIN 81 mg/1 N 20181231 68196-604_5d16dcf4-d51f-4ce4-98ef-b7ead987f7be 68196-604 HUMAN OTC DRUG simply right ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20111218 ANDA ANDA072096 Sam's West Inc IBUPROFEN 200 mg/1 N 20181231 68196-612_95630ab3-ce64-4914-8b96-d8747916c6fa 68196-612 HUMAN OTC DRUG Members Mark Loratadine Loratadine TABLET ORAL 20070521 ANDA ANDA076301 Sam's West Inc LORATADINE 10 mg/1 N 20181231 68196-690_af2bd762-ca4b-436e-9aa4-95fd9cfcdaa4 68196-690 HUMAN OTC DRUG Allergy Relief Antihistamine Diphenhydramine Hydrochloride TABLET ORAL 20111030 OTC MONOGRAPH FINAL part336 SIMPLY RIGHT (Sam's West, Inc.) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68196-702_05fb437b-3771-4814-ae07-6068b009680b 68196-702 HUMAN OTC DRUG simply right cetirizine hydrochloride Cetirizine Hydrochloride TABLET ORAL 20130410 ANDA ANDA078336 Sam's West Inc CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 68196-734_fb2125a8-f4d2-4108-a590-0b1876d7d6a7 68196-734 HUMAN OTC DRUG members mark Nicotine Nicotine Polacrilex LOZENGE ORAL 20150721 ANDA ANDA203690 Sam's West Inc NICOTINE 2 mg/1 N 20181231 68196-735_d678bf66-b16a-4f44-8da1-b15b98af439b 68196-735 HUMAN OTC DRUG Members Mark mucus relief DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20160901 ANDA ANDA091070 Sam's West Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 68196-798_73858a95-4f3f-4b1c-bbd6-2995c79bdca3 68196-798 HUMAN OTC DRUG simply right minoxidil extra strength Minoxidil SOLUTION TOPICAL 20110630 ANDA ANDA075598 Sam's West Inc MINOXIDIL 3 g/60mL N 20181231 68196-803_791b95e2-c264-425c-9f39-69cf48b8602e 68196-803 HUMAN OTC DRUG SIMPLY RIGHT ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20121015 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN 1.5 mg/mL N 20181231 68196-804_b50cf0e6-999f-473a-8e4c-4b7842b1dda6 68196-804 HUMAN OTC DRUG ANTIBACTERIAL SPARKLING MIST TRICLOSAN SOLUTION TOPICAL 20110617 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC TRICLOSAN .15 mL/100mL N 20181231 68196-808_aea2d91d-9cf8-435a-b4b2-35b0389165aa 68196-808 HUMAN OTC DRUG SIMPLY RIGHT SPARKLING MIST TRICLOSAN LIQUID TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC TRICLOSAN 1.5 mg/mL N 20181231 68196-809_f1c33970-1c3f-4b87-b743-c943535a4ae0 68196-809 HUMAN OTC DRUG SIMPLY RIGHT BODY CARE SPARKLING MIST TRICLOSAN LIQUID TOPICAL 20130812 OTC MONOGRAPH NOT FINAL part333E SAM'S WEST INC. TRICLOSAN 1.5 mg/mL N 20181231 68196-873_12ec11ea-d7bd-4741-82c1-95f07abab68d 68196-873 HUMAN OTC DRUG Members Mark Nicotine Nicotine Polacrilex LOZENGE ORAL 20070907 ANDA ANDA077007 Sam's West Inc NICOTINE 4 mg/1 N 20181231 68196-900_69069548-81b8-43db-9d3c-7bf2b635876a 68196-900 HUMAN OTC DRUG aspirin low strength adult aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc ASPIRIN 81 mg/1 N 20181231 68196-915_7f72a8f3-a3df-4941-8814-74a08bd2f221 68196-915 HUMAN OTC DRUG members mark omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080225 NDA NDA022032 Sam's West Inc OMEPRAZOLE 20 mg/1 N 20181231 68196-919_288611e9-e4ad-45ab-b7b3-7fb7834370d8 68196-919 HUMAN OTC DRUG acetaminophen extra strength acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Sam's West Inc ACETAMINOPHEN 500 mg/1 N 20181231 68196-929_a51da0f1-6c1f-449d-ba4b-d5d065ba8b5d 68196-929 HUMAN OTC DRUG diphenhydramine diphenhydramine HCl TABLET, COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 Sam's West Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68196-932_58a22a6a-78de-4a57-ae48-6cbf074e2a8f 68196-932 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20051222 20200822 OTC MONOGRAPH FINAL part341 Sam's West Inc GUAIFENESIN 400 mg/1 N 20181231 68196-951_c79f1452-5195-439b-87fe-58c6e55dc1a4 68196-951 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140908 OTC MONOGRAPH NOT FINAL part333A Sam's West Inc ALCOHOL 578 mg/mL N 20181231 68196-957_1dc02a65-99ce-4874-a1ee-b8d940610b62 68196-957 HUMAN OTC DRUG members mark mini nicotine Nicotine Polacrilex LOZENGE ORAL 20150721 ANDA ANDA203690 Sam's West Inc NICOTINE 4 mg/1 N 20181231 68196-975_4945e21e-cc22-4b60-97c9-42ec5b970945 68196-975 HUMAN OTC DRUG anti-diarrheal Loperamide HCl TABLET ORAL 20050503 ANDA ANDA076497 Sam's West Inc LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 68196-976_53d6c830-060b-4427-8acc-51a6c50f8a11 68196-976 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20150115 ANDA ANDA202039 Sam's West Inc FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 68196-977_bdcbdb5a-7dad-42a4-96d1-05e172ab31ba 68196-977 HUMAN OTC DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20171016 ANDA ANDA209339 Sam's West Inc ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg/1 N 20181231 68196-980_d592a654-667a-44e6-8d9c-3dd94fb7ae42 68196-980 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20171113 ANDA ANDA206568 Sam's West, Inc. IBUPROFEN 200 mg/1 N 20181231 68209-843_0e0a702d-888c-e29e-e8bf-9910b8719d1c 68209-843 PLASMA DERIVATIVE Octagam Immune Globulin (Human) Immune Globulin SOLUTION INTRAVENOUS 20060414 BLA BLA125062 Octapharma AB HUMAN IMMUNOGLOBULIN G 50 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] E 20171231 68210-0001_bc82778e-46c6-4bc3-86f8-c6209faeb8bf 68210-0001 HUMAN OTC DRUG Y LAX DR BISACODYL TABLET, SUGAR COATED ORAL 20100501 OTC MONOGRAPH NOT FINAL part334 SPIRIT PHARMACEUTICALS,LLC BISACODYL 5 mg/1 E 20171231 68210-0002_5d1f922b-62f7-41e7-849d-6bc036138e59 68210-0002 HUMAN OTC DRUG P LAX DR BISACODYL TABLET, SUGAR COATED ORAL 20100501 OTC MONOGRAPH NOT FINAL part334 SPIRIT PHARMACEUTICALS,LLC BISACODYL 5 mg/1 E 20171231 68210-0005_5e6f16e6-9ad4-78b7-e053-2991aa0a7aac 68210-0005 HUMAN OTC DRUG DEXTROMETHORPHAN Hydrobromide DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20171122 OTC MONOGRAPH FINAL part341 Spirit Pharmaceuticals LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 68210-0007_0935b09d-5609-4cc5-a65c-e5da29bc9449 68210-0007 HUMAN OTC DRUG FAMOTIDINE FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130819 ANDA ANDA077146 SPIRIT PHARMACEUTICALS,LLC FAMOTIDINE 10 mg/1 E 20171231 68210-0009_5e6ec98a-98ab-138f-e053-2991aa0a77e1 68210-0009 HUMAN OTC DRUG IBUPROFEN IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20171122 ANDA ANDA079205 SPIRIT PHARMACEUTICALS,LLC IBUPROFEN 220 mg/1 N 20181231 68210-0012_da770899-4313-4d63-874e-34ef0ca63923 68210-0012 HUMAN OTC DRUG ASSURED REGULAR STRENGTH ACETAMINOPHEN ACETAMINOPHEN CAPSULE, GELATIN COATED ORAL 20160812 OTC MONOGRAPH NOT FINAL part343 SPIRIT PHARMACEUTICALS LLC ACETAMINOPHEN 325 mg/1 E 20171231 68210-0013_4c96ad42-0919-2c19-e054-00144ff8d46c 68210-0013 HUMAN OTC DRUG EXTRA STRENGTH ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20160812 OTC MONOGRAPH NOT FINAL part343 Spirit Pharmaceutical LLC ACETAMINOPHEN 500 mg/1 N 20181231 68210-0015_8fffefce-e929-4411-bc4f-91adf9ac319c 68210-0015 HUMAN OTC DRUG ASSURED ASPIRIN ASPIRIN TABLET, DELAYED RELEASE ORAL 20160701 OTC MONOGRAPH NOT FINAL part343 SPIRIT PHARMACEUTICALS LLC ASPIRIN 81 mg/1 N 20181231 68210-0017_4d9f9fe4-ede4-4418-e054-00144ff88e88 68210-0017 HUMAN OTC DRUG EXTRA STRENGHT HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET ORAL 20160818 OTC MONOGRAPH NOT FINAL part343 Spirit Pharmaceutical LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 68210-0020_79f6e8ad-e856-40ba-b835-eb1fe311ca41 68210-0020 HUMAN OTC DRUG Assured Headache PM (Aspirin Free) Acetaminophen and Diphenhydramine Citrate TABLET, COATED ORAL 20160812 OTC MONOGRAPH NOT FINAL part343 Spirit Pharmaceutical LLC ACETAMINOPHEN; DIPHENHYDRAMINE CITRATE 500; 38 mg/1; mg/1 N 20181231 68210-0022_4f97a994-4c44-2f4a-e054-00144ff88e88 68210-0022 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20170519 OTC MONOGRAPH NOT FINAL part343 SPIRIT PHARMACEUTICALS LLC ACETAMINOPHEN 325 mg/1 N 20181231 68210-0040_60dee681-fc0c-32cf-e053-2a91aa0a44f3 68210-0040 HUMAN OTC DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171222 ANDA ANDA091353 SPIRIT PHARMACEUTICALS,LLC NAPROXEN SODIUM 220 mg/1 N 20181231 68210-0080_60c8df27-ce87-aa38-e053-2a91aa0a49a3 68210-0080 HUMAN OTC DRUG Assured Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20171122 ANDA ANDA091239 Spirit Pharmaceutical LLC IBUPROFEN 200 mg/1 N 20181231 68210-0081_60c8ecbf-0c8e-bce4-e053-2a91aa0a1ae3 68210-0081 HUMAN OTC DRUG Assured Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20171215 ANDA ANDA079174 Spirit Pharmaceutical LLC IBUPROFEN 200 mg/1 N 20181231 68210-0101_896b3914-8b53-4fcd-94d9-e84daf967cfe 68210-0101 HUMAN OTC DRUG ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20091015 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 68210-0102_07411e45-3c8d-4353-a9c4-3c14c0e29e67 68210-0102 HUMAN OTC DRUG ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20091015 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 68210-0104_7ef0cb14-c430-4753-8a4e-a5319927d7a1 68210-0104 HUMAN OTC DRUG MULTI-SYMPTOM DAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20160220 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 68210-0105_b56ea55c-b878-4081-8899-eabd279bb88e 68210-0105 HUMAN OTC DRUG MULTI-SYMPTOM NITETIME ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED ORAL 20160220 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 68210-0111_d77bec74-2c20-4af8-ab25-de94be40f298 68210-0111 HUMAN OTC DRUG ASSURED MAXIMUM STRENGTH MUCUS RELIEF ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, GELATIN COATED ORAL 20160812 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 68210-0130_4f92a547-cfd9-4a66-e054-00144ff8d46c 68210-0130 HUMAN OTC DRUG VALUMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN TABLET ORAL 20170515 OTC MONOGRAPH NOT FINAL part343 SPIRIT PHARMACEUTICALS LLC ACETAMINOPHEN 500 mg/1 N 20181231 68210-0150_4f5855b7-d3d7-3477-e054-00144ff8d46c 68210-0150 HUMAN OTC DRUG VALUMEDS ASPIRIN ASPIRIN TABLET, DELAYED RELEASE ORAL 20170515 OTC MONOGRAPH NOT FINAL part343 SPIRIT PHARMACEUTICALS LLC ASPIRIN 81 mg/1 N 20181231 68210-0170_3d6771ec-47fd-4421-bb06-829dd380d26b 68210-0170 HUMAN OTC DRUG EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, and CAFFEINE CAPSULE, GELATIN COATED ORAL 20160627 OTC MONOGRAPH NOT FINAL part343 Spirit Pharmaceutical LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 68210-0302_4fba58d3-a0f5-747c-e054-00144ff8d46c 68210-0302 HUMAN OTC DRUG SENNA-S DOCUSATE SODIUM AND SENNOSIDES TABLET ORAL 20170519 OTC MONOGRAPH NOT FINAL part334 Spirit Pharmaceuticals LLC DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 68210-0305_4fab4262-57e1-06f1-e054-00144ff8d46c 68210-0305 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170518 OTC MONOGRAPH NOT FINAL part334 Spirit Pharmaceuticals LLC DOCUSATE SODIUM 100 mg/1 N 20181231 68210-0310_4f951b56-042f-4f76-e054-00144ff88e88 68210-0310 HUMAN OTC DRUG VALUMEDS NATURAL LAXATIVE SENNOSIDES TABLET, FILM COATED ORAL 20170518 OTC MONOGRAPH NOT FINAL part334 Spirit Pharmaceuticals LLC SENNOSIDES 8.6 mg/1 N 20181231 68210-0312_4fa958d5-1037-0a2c-e054-00144ff88e88 68210-0312 HUMAN OTC DRUG BISACODYL BISACODYL TABLET, DELAYED RELEASE ORAL 20170519 OTC MONOGRAPH NOT FINAL part334 SPIRIT PHARMACEUTICALS LLC BISACODYL 5 mg/1 N 20181231 68210-0400_60cd2d93-833c-5ef0-e053-2a91aa0a45dd 68210-0400 HUMAN OTC DRUG NAPROXEN SODIUM NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171122 ANDA ANDA090545 SPIRIT PHARMACEUTICALS,LLC NAPROXEN SODIUM 220 mg/1 N 20181231 68210-0401_09ea20a4-6502-4c60-bca9-86b493b5b1e3 68210-0401 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20100301 OTC MONOGRAPH NOT FINAL part334 SPIRIT PHARMACEUTICALS,LLC DOCUSATE SODIUM 100 mg/1 N 20181231 68210-0402_5a59a01e-65e5-484d-8d4e-a25bef6dc4ab 68210-0402 HUMAN OTC DRUG DOCUSATE SODIUM DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20091001 OTC MONOGRAPH FINAL part310.545 SPIRIT PHARMACEUTICALS,LLC DOCUSATE SODIUM 50 mg/1 N 20181231 68210-0800_50202e3e-d138-457b-e054-00144ff8d46c 68210-0800 HUMAN OTC DRUG VALUMEDS IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20170519 ANDA ANDA091239 SPIRIT PHARMACEUTICALS LLC IBUPROFEN 200 mg/1 N 20181231 68210-1000_4c97b572-4045-5d42-e054-00144ff8d46c 68210-1000 HUMAN OTC DRUG EXTRA STRENGTH ACETAMINOPHEN PM ACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20160812 OTC MONOGRAPH NOT FINAL part343 Spirit Pharmaceutical LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 68210-1001_4d9f9e35-04bb-43f2-e054-00144ff88e88 68210-1001 HUMAN OTC DRUG ALLERGY RELIEF DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160818 OTC MONOGRAPH FINAL part341 Spirit Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68210-1002_84a52ec2-aa29-4877-95c4-3e7be450d1aa 68210-1002 HUMAN OTC DRUG Assured Allergy Relief Diphenhydramine Hydrochloride TABLET, FILM COATED ORAL 20160701 OTC MONOGRAPH NOT FINAL part348 Spirit Pharmaceutical LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68210-1470_a9df99cc-ede3-4b7b-831d-f187e8f4794f 68210-1470 HUMAN OTC DRUG D TIME SINUS ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100301 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS,LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 68210-1480_f717106a-0bf5-4df3-adb1-0d54e406e2a3 68210-1480 HUMAN OTC DRUG N - TIME SINUS ACETAMINOPHEN, DOXYLAMINE SUCCINATE, and PHENYLEPHRINE Hydrochloride CAPSULE, LIQUID FILLED ORAL 20100301 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS,LLC ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 6.25; 5 mg/1; mg/1; mg/1 N 20181231 68210-1490_2b51f558-dafe-4807-8bd9-d5753a427bc7 68210-1490 HUMAN OTC DRUG D - TIME ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20100530 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS,LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 325; 5; 10 mg/1; mg/1; mg/1 N 20181231 68210-1500_fb2cad6f-707b-4e89-80f9-9c155bc7bff6 68210-1500 HUMAN OTC DRUG N - TIME ACETAMINOPHEN, DOXYLAMINE SUCCINATE, and DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20100530 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS,LLC ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE 325; 6.25; 15 mg/1; mg/1; mg/1 N 20181231 68210-1510_76d8de20-70b3-4727-9dea-d31d1b1e970d 68210-1510 HUMAN OTC DRUG DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20100601 OTC MONOGRAPH FINAL part338 SPIRIT PHARMACEUTICALS,LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 68210-1520_0fe4df43-f430-4cf1-9033-43387e7db002 68210-1520 HUMAN OTC DRUG FERROUS SULFATE FERROUS SULFATE, DRIED TABLET, FILM COATED ORAL 20101215 UNAPPROVED DRUG OTHER SPIRIT PHARMACEUTICALS,LLC FERROUS SULFATE, DRIED 325 mg/1 E 20171231 68210-1520_a71178c0-3156-4c4e-a189-357939a27e27 68210-1520 HUMAN OTC DRUG FERROUS SULFATE FERROUS SULFATE, DRIED TABLET, FILM COATED ORAL 20101215 UNAPPROVED DRUG OTHER SPIRIT PHARMACEUTICALS,LLC FERROUS SULFATE, DRIED 325 mg/1 E 20171231 68210-1530_9e5110a5-04b0-4442-b095-d45e04c2266a 68210-1530 HUMAN OTC DRUG DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED ORAL 20100715 OTC MONOGRAPH FINAL part341 SPIRIT PHARMACEUTICALS,LLC DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 N 20181231 68210-1901_76774f7e-63c1-4ce3-8e70-07bb9408b59a 68210-1901 HUMAN OTC DRUG SIMETHICONE DIMETHICONE CAPSULE, LIQUID FILLED ORAL 20100301 OTC MONOGRAPH FINAL part332 SPIRIT PHARMACEUTICALS,LLC DIMETHICONE 125 mg/1 N 20181231 68210-1902_ff5ca266-7b84-4f5c-8618-3b08556b964e 68210-1902 HUMAN OTC DRUG SIMETHICONE DIMETHICONE CAPSULE, LIQUID FILLED ORAL 20091001 OTC MONOGRAPH FINAL part310.545 SPIRIT PHARMACEUTICALS,LLC DIMETHICONE 180 mg/1 N 20181231 68220-055_251eb269-e7ae-11e1-aff1-0800200c9a66 68220-055 HUMAN PRESCRIPTION DRUG Anadrol-50 oxymetholone TABLET ORAL 19720601 NDA NDA016848 Alaven Pharmaceutical OXYMETHOLONE 50 mg/1 CIII N 20181231 68220-083_083a5779-4727-430f-ae00-674122bbdf51 68220-083 HUMAN PRESCRIPTION DRUG PreferaOB plus DHA FOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN, Potassium Iodide, Zinc Oxide, Selenium, CUPRIC SULFATE, CHOLECALCIFEROL, THIAMINE MONONITRATE, ALPHA-TOCOPHEROL SUCCINATE, D-, RIBOFLAVIN, NIACINAMIDE, TABLET ORAL 20101115 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; SELENIUM; CUPRIC SULFATE; CHOLECALCIFEROL; THIAMINE MONONITRATE; ALPHA-TOCOPHEROL SUCCINATE, D-; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE 1; 6; 28; 250; 4.5; 65; .8; 400; 1.5; 10; 1.6; 17; 50; 12; 30; 10 mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1 Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 68220-084_aa72cc66-8257-4185-b563-894032636337 68220-084 HUMAN PRESCRIPTION DRUG PreferaOB FOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN, Potassium Iodide, Zinc Oxide, Selenium, CUPRIC SULFATE, CHOLECALCIFEROL, THIAMINE MONONITRATE, ALPHA-TOCOPHEROL SUCCINATE, D-, RIBOFLAVIN, NIACINAMIDE, TABLET ORAL 20100927 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; SELENIUM; CUPRIC SULFATE; CHOLECALCIFEROL; THIAMINE MONONITRATE; ALPHA-TOCOPHEROL SUCCINATE, D-; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE 1; 6; 28; 250; 4.5; 65; .8; 400; 1.5; 10; 1.6; 17; 50; 12; 30; 10 mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 68220-085_ff690efc-acac-4103-98ad-3a1613dc5573 68220-085 HUMAN PRESCRIPTION DRUG BiferaRx FOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN, and CYANOCOBALAMIN TABLET ORAL 20100501 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; CYANOCOBALAMIN 1; 6; 22; 25 mg/1; mg/1; mg/1; ug/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 68220-086_69e082a6-77dd-46e0-b3eb-90bb6d167b82 68220-086 HUMAN PRESCRIPTION DRUG PreferaOB One folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, ascorbic acid, cholecalciferol, doconexent, .alpha.-tocopherol acetate, dl-, niacinamide, pyridoxine hydrochloride, cyano CAPSULE ORAL 20100401 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; ASCORBIC ACID; CHOLECALCIFEROL; DOCONEXENT; .ALPHA.-TOCOPHEROL ACETATE, DL-; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE 1; 6; 22; 175; 15; 25; 400; 200; 10; 17; 50; 12; 30; 10 mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 68220-089_c697dfae-210c-43a6-b893-f3054e74901c 68220-089 HUMAN PRESCRIPTION DRUG Prefera OB plus DHA FOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN, Potassium Iodide, Zinc Oxide, Selenium, CUPRIC SULFATE, CHOLECALCIFEROL, THIAMINE MONONITRATE, ALPHA-TOCOPHEROL SUCCINATE, D-, RIBOFLAVIN, NIACINAMIDE, TABLET ORAL 20090401 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC FOLIC ACID; HEME IRON POLYPEPTIDE; IRON DEXTRAN; POTASSIUM IODIDE; ZINC OXIDE; SELENIUM; CUPRIC SULFATE; CHOLECALCIFEROL; THIAMINE MONONITRATE; ALPHA-TOCOPHEROL SUCCINATE, D-; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE 1; 6; 22; 175; 15; 65; .8; 400; 1.5; 10; 1.6; 17; 50; 12; 30; 10 mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1 Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 68220-111_0a65eb2f-7e37-4caf-8fd5-ec2eb1349a4e 68220-111 HUMAN PRESCRIPTION DRUG Levsin HYOSCYAMINE SULFATE INJECTION, SOLUTION SUBCUTANEOUS 20081201 20181031 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC HYOSCYAMINE SULFATE .5 mg/mL N 20181231 68220-112_6667c71b-685e-4821-99be-c420fd582b8a 68220-112 HUMAN PRESCRIPTION DRUG Levsin hyoscyamine sulfate TABLET ORAL 19550601 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 68220-113_e8df3b1b-c4b0-4e76-b70b-8fe090d5f5b4 68220-113 HUMAN PRESCRIPTION DRUG Levsin SL hyoscyamine sulfate TABLET, ORALLY DISINTEGRATING ORAL 20081201 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 68220-115_99936320-1323-4ccd-8782-0772043cfd9c 68220-115 HUMAN PRESCRIPTION DRUG Levbid hyoscyamine sulfate TABLET, EXTENDED RELEASE ORAL 20081201 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC HYOSCYAMINE SULFATE .375 mg/1 N 20181231 68220-118_43113553-f18a-4ca6-b5c7-f6db9bda02bb 68220-118 HUMAN PRESCRIPTION DRUG NuLev hyoscyamine sulfate TABLET, CHEWABLE ORAL 20081201 UNAPPROVED DRUG OTHER Alaven Pharmaceutical LLC HYOSCYAMINE SULFATE .125 mg/1 N 20181231 68220-130_98c68a99-158c-11e3-8ffd-0800200c9a66 68220-130 HUMAN PRESCRIPTION DRUG Colyte with flavor packs Polyethylene glycol 3350, Sodium chloride, Potassium chloride, Sodium bicarbonate, and Sodium sulfate POWDER, FOR SOLUTION NASOGASTRIC; ORAL 19990407 NDA NDA018983 Alaven Pharmaceutical LLC POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM SULFATE 240; 5.84; 2.98; 6.72; 22.72 g/4L; g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 68220-131_e0274a28-194d-4d9e-9421-61e399ff0b9b 68220-131 HUMAN PRESCRIPTION DRUG TRILYTE with flavor packs Polyethylene Glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride POWDER, FOR SOLUTION NASOGASTRIC; ORAL 20040624 ANDA ANDA076491 Alaven Pharmaceutical LLC POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE 420; 11.2; 5.72; 1.48 g/4L; g/4L; g/4L; g/4L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 68220-133_98c68a88-158c-11e3-8ffd-0800200c9a66 68220-133 HUMAN PRESCRIPTION DRUG Colyte POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, and SODIUM SULFATE ANHYDROUS POWDER, FOR SOLUTION NASOGASTRIC; ORAL 20100901 NDA NDA018983 Alaven Pharmaceutical LLC POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM SULFATE 227.1; 5.53; 2.82; 6.36; 21.5 g/3.785L; g/3.785L; g/3.785L; g/3.785L; g/3.785L Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 68220-140_90bba35d-271b-4c95-9dde-6e4d43f97822 68220-140 HUMAN PRESCRIPTION DRUG Cortifoam hydrocortisone acetate AEROSOL, FOAM RECTAL 19820212 NDA NDA017351 Alaven Pharmaceutical LLC HYDROCORTISONE ACETATE 1500 mg/15g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68220-141_02ef1480-500b-11e0-b8af-0800200c9a66 68220-141 HUMAN PRESCRIPTION DRUG Proctocream HC Hydrocortisone CREAM TOPICAL 20110318 ANDA ANDA089414 Alaven Pharmaceutical LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68220-142_6a3a7450-e6f4-11e1-aff1-0800200c9a66 68220-142 HUMAN PRESCRIPTION DRUG Proctofoam HC hydrocortisone acetate and pramoxine hydrochloride AEROSOL, FOAM TOPICAL 19780726 ANDA ANDA086195 Alaven Pharmaceutical LLC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 100; 100 mg/10g; mg/10g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68220-143_f2bdbe25-0124-4b39-ab04-77d2250b5835 68220-143 HUMAN OTC DRUG Proctofoam pramoxine hydrochloride AEROSOL, FOAM RECTAL 19900930 OTC MONOGRAPH FINAL part346 Alaven Pharmaceutical LLC PRAMOXINE HYDROCHLORIDE 150 mg/15g N 20181231 68220-144_cc56b07d-845a-4729-ad94-ee691215afac 68220-144 HUMAN PRESCRIPTION DRUG Epifoam hydrocortisone acetate and pramoxine hydrochloride AEROSOL, FOAM TOPICAL 19791219 ANDA ANDA086457 Alaven Pharmaceutical LLC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 100; 100 mg/10g; mg/10g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68220-160_6394448c-9f58-4243-be16-b52fd228ad04 68220-160 HUMAN PRESCRIPTION DRUG Dipentum olsalazine sodium CAPSULE, GELATIN COATED ORAL 19900731 NDA NDA019715 Alaven Pharmaceutical LLC OLSALAZINE SODIUM 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 68229-100_cb5fe497-1b2f-4fb1-968f-896daf62fd40 68229-100 HUMAN OTC DRUG Skin Tag Relief Thuja Occidentalis Leafy Twig OIL TOPICAL 20130521 UNAPPROVED HOMEOPATHIC Quest Products, Inc. THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/10mL N 20181231 68229-200_cdb574f7-23b3-4f99-8b63-a92f5625a76a 68229-200 HUMAN OTC DRUG Alocane Lidocaine Hydrochloride OINTMENT TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part348 Quest Products, Inc. LIDOCAINE HYDROCHLORIDE 4 g/100mL N 20181231 68229-300_a88a45f5-28ad-48b7-bcc6-87c75b15ede3 68229-300 HUMAN OTC DRUG Alocane Plus Lidocaine Hydrochloride and Benzalkonium Chloride OINTMENT TOPICAL 20131211 OTC MONOGRAPH NOT FINAL part348 Quest Products, Inc. LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE 4; .13 g/100mL; g/100mL N 20181231 68229-400_e0fbf14b-929a-4c53-8b06-fe54c925c2fd 68229-400 HUMAN OTC DRUG Alocane LIDOCAINE HYDROCHLORIDE and HYDROCORTISONE ACETATE OINTMENT TOPICAL 20141111 OTC MONOGRAPH NOT FINAL part348 Quest Products, Inc. LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE 945; 5 mg/mL; mg/mL N 20181231 68229-401_f917fe31-8d1e-492b-b425-b6ce1b82622e 68229-401 HUMAN OTC DRUG Alocane Severe Sunburn Lidocaine Hydrochloride GEL TOPICAL 20170213 OTC MONOGRAPH NOT FINAL part348 Quest Products, Inc. LIDOCAINE HYDROCHLORIDE 4 g/100mL N 20181231 68229-402_3b4f2101-f981-4cc3-8948-64b5a63cf446 68229-402 HUMAN OTC DRUG Alocane On The Go LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20170213 OTC MONOGRAPH NOT FINAL part348 Quest Products, Inc. LIDOCAINE HYDROCHLORIDE 4 g/100mL N 20181231 68229-403_ca1d9671-4973-42ab-b593-7b6db896a588 68229-403 HUMAN OTC DRUG Alocane Emergency Burn Pads LIDOCAINE HYDROCHLORIDE SWAB TOPICAL 20170213 OTC MONOGRAPH NOT FINAL part348 Quest Products, Inc. LIDOCAINE HYDROCHLORIDE 4 g/100mL N 20181231 68229-500_6992fab5-6a2b-45c8-9d2d-e097ccfa3234 68229-500 HUMAN OTC DRUG CopperFixx Capsaicin OINTMENT TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 Quest Products, Inc. CAPSAICIN .25 g/100mL N 20181231 68229-502_24bc1673-2325-465f-b0de-1863fbea7aa6 68229-502 HUMAN OTC DRUG CopperFixx Copper and Arnica Montana OINTMENT TOPICAL 20160101 UNAPPROVED HOMEOPATHIC Quest Products, Inc. COPPER; ARNICA MONTANA 11; 4 [hp_X]/57g; [hp_X]/57g N 20181231 68233-012_5c27331d-4b7f-517d-e053-2a91aa0ad74f 68233-012 HUMAN OTC DRUG Herbal UTAPLAS.TN MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20041201 20180331 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL; METHYL SALICYLATE .05; .005 g/g; g/g N 20181231 68233-801_509a4984-94a4-432a-ae22-a1e0a7b21f1d 68233-801 HUMAN OTC DRUG MaxRevive Plaster MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .04; .01 g/g; g/g N 20181231 68233-801_a970c66c-6095-401c-8ada-9972e210db07 68233-801 HUMAN OTC DRUG MaxRevive Plaster MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .04; .01 g/g; g/g N 20181231 68233-802_9b2f72e4-5d8b-4e98-89ae-a3ea7c30b822 68233-802 HUMAN OTC DRUG SC HERBAL PAIN RELIEVING MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .04; .01 g/g; g/g N 20181231 68233-803_471b4369-432d-4cad-bd91-2035e412fef4 68233-803 HUMAN OTC DRUG Herbal UTAPLAS External Analgesic Plaster MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20041201 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .04; .01 g/g; g/g N 20181231 68233-804_125c4d65-0037-4cc7-bfc9-db323e674c12 68233-804 HUMAN OTC DRUG ZHONG HUA FENG SHI DIE DA GAO External Analgesic Plaster MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20051101 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .04; .01 g/g; g/g N 20181231 68233-805_0ff4dd32-77be-477f-92ea-a1debed65c30 68233-805 HUMAN OTC DRUG MaxRevive Pain relieving MENTHOL, METHYL SALICYLATE SPRAY TOPICAL 20030901 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .1; .05 g/mL; g/mL N 20181231 68233-806_b3d558d6-664c-4939-9a90-f4360f6b92b4 68233-806 HUMAN OTC DRUG SC PAIN RELIEF BALM Methyl Salicylate, Menthol, Camphor OINTMENT TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL) 207.3; 155.5; 31.1 mg/g; mg/g; mg/g N 20181231 68233-807_21ec323f-311b-452e-8f0a-7de41b02d63e 68233-807 HUMAN OTC DRUG Pain Relief Herbal balm METHYL SALICYLATE, MENTHOL, CAMPHOR OINTMENT TOPICAL 20060901 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL) 207.3; 155.5; 31.1 mg/g; mg/g; mg/g N 20181231 68233-808_f178dcad-38f1-4c76-8e39-ab374e2cdf93 68233-808 HUMAN OTC DRUG Top Medicated Pain Relieving CAMPHOR, MENTHOL, METHYL SALICYLATE OIL TOPICAL 20120524 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .1; .16; .4 g/mL; g/mL; g/mL N 20181231 68233-809_b4e71a73-a047-4bc1-bf0a-caa4362cb286 68233-809 HUMAN OTC DRUG HERBAL PAIN RELIEVING Menthol, Methyl Salicylate, Camphor OIL TOPICAL 20090701 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; CAMPHOR (NATURAL) .16; .4; .1 g/mL; g/mL; g/mL N 20181231 68233-810_62984bb7-8823-4999-e053-2a91aa0a8f38 68233-810 HUMAN OTC DRUG AA Top Medicated Menthol and Methyl Salicylate OIL TOPICAL 20180201 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL; METHYL SALICYLATE .1; .05 g/mL; g/mL N 20191231 68233-901_5c27f5e7-0849-74a2-e053-2991aa0ac09c 68233-901 HUMAN OTC DRUG Herbal UTAPLAS.TN MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20041201 20180331 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL; METHYL SALICYLATE .05; .01 g/g; g/g N 20181231 68233-902_5c27f5e7-086b-74a2-e053-2991aa0ac09c 68233-902 HUMAN OTC DRUG Max Revive MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20030901 20180331 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL; METHYL SALICYLATE .05; .01 g/g; g/g N 20181231 68233-904_5c27331d-4b6e-517d-e053-2a91aa0ad74f 68233-904 HUMAN OTC DRUG DRAGON CAMPHOR (NATURAL), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE OIL TOPICAL 20090701 20180228 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .1; .16; .5 g/mL; g/mL; g/mL N 20181231 68233-905_5c27f5e7-085a-74a2-e053-2991aa0ac09c 68233-905 HUMAN OTC DRUG Herbal UTAPLAS.TN Menthol, Methyl Salicylate PLASTER TOPICAL 20041201 20180331 OTC MONOGRAPH NOT FINAL part348 Albert Max, Inc. MENTHOL; METHYL SALICYLATE .05; .01 g/g; g/g N 20181231 68258-1104_0f8b0d18-94a9-4e99-a354-0f0fc40039dd 68258-1104 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 Dispensing Solutions, Inc. ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] E 20171231 68258-1107_6b55d24c-094e-4ff0-80af-494574378d75 68258-1107 HUMAN PRESCRIPTION DRUG XIFAXAN RIFAXIMIN TABLET ORAL 20040725 NDA NDA021361 Dispensing Solutions, Inc. RIFAXIMIN 200 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 68258-1972_dbcafc5a-44f8-4f8f-92ed-ed6c3b466f6e 68258-1972 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20100618 NDA NDA021906 Dispensing Solutions, Inc. LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] E 20171231 68258-2003_c8366081-d57b-4c2e-8000-d4c607d6029f 68258-2003 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE ORAL 20091113 ANDA ANDA078783 Dispensing Solutions, Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 68258-2012_602e7e89-3dfe-40fe-82ae-de285a2496f6 68258-2012 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Butalbital, Acetaminophen, Caffeine and Codeine Phosphate CAPSULE ORAL 20040701 ANDA ANDA076560 Dispensing Solutions, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII E 20171231 68258-2992_be0d579b-3b66-4227-b532-b0ee186a24ad 68258-2992 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20091029 ANDA ANDA077086 Dispensing Solutions, Inc. LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] E 20171231 68258-2993_c13a4b50-3fd0-4242-a7e8-09516ec2ea08 68258-2993 HUMAN OTC DRUG MEDROX MENTHOL, CAPSAICIN PATCH TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part348 Dispensing Solutions, Inc. MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g E 20171231 68258-2994_a601000f-dbf5-4d7b-b1d2-72bfb36db5ea 68258-2994 HUMAN OTC DRUG Good Sense ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20041109 ANDA ANDA076359 Dispensing Solutions, Inc. IBUPROFEN 100 mg/1 E 20171231 68258-2997_9dc38d56-7e5a-4938-b63b-6ca4aecbca94 68258-2997 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20110722 OTC MONOGRAPH NOT FINAL part348 Dispensing Solutions, Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 30; 10; .025 g/60mL; g/60mL; g/60mL E 20171231 68258-3000_c5e7e4ab-39fc-4095-818e-c1e43fb1d77b 68258-3000 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090413 ANDA ANDA090278 Dispensing Solutions Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68258-3001_c5e7e4ab-39fc-4095-818e-c1e43fb1d77b 68258-3001 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090413 ANDA ANDA090278 Dispensing Solutions Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68258-3002_c5e7e4ab-39fc-4095-818e-c1e43fb1d77b 68258-3002 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090413 ANDA ANDA090278 Dispensing Solutions Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68258-3006_26c7935e-4425-4a24-a7af-caa1db3585a1 68258-3006 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20090122 ANDA ANDA075616 Dispensing Solutions Inc. NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 68258-3008_88e7bd4f-82ac-4d50-bbb1-a30340412e80 68258-3008 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET, FILM COATED ORAL 20090303 NDA NDA020132 Dispensing Solutions Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 68258-3009_88e7bd4f-82ac-4d50-bbb1-a30340412e80 68258-3009 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET, FILM COATED ORAL 20090303 NDA NDA020132 Dispensing Solutions Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 68258-3011_8ea345d3-5453-4c02-bbfd-55f0bdacffb2 68258-3011 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE SUPPOSITORY RECTAL 20031219 ANDA ANDA123456 Dispensing Solutions Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 68258-3012_9203a55b-aa44-428c-890a-58208fd01bf4 68258-3012 HUMAN PRESCRIPTION DRUG AZITHROMYCIN AZITHROMYCIN TABLET, FILM COATED ORAL 20080530 ANDA ANDA065405 Dispensing Solutions Inc. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 68258-3013_e048ce21-7296-4163-9528-8a1b7c9d6ad1 68258-3013 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20080529 ANDA ANDA040256 Dispensing Solutions Inc. PREDNISONE 5 mg/1 E 20171231 68258-3014_8de3b358-74d1-485b-bf3d-f70a6140bf81 68258-3014 HUMAN PRESCRIPTION DRUG Alendronate Sodium alendronate sodium TABLET ORAL 20090303 ANDA ANDA076984 Dispensing Solutions Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 68258-3023_0cd9cc40-f972-4d65-8d4a-cff05c03ad07 68258-3023 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20061106 ANDA ANDA077449 Dispensing Solutions Inc. FENTANYL 25 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 68258-3024_0cd9cc40-f972-4d65-8d4a-cff05c03ad07 68258-3024 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20061106 ANDA ANDA077449 Dispensing Solutions Inc. FENTANYL 75 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 68258-3025_0cd9cc40-f972-4d65-8d4a-cff05c03ad07 68258-3025 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH, EXTENDED RELEASE TRANSDERMAL 20061106 ANDA ANDA077449 Dispensing Solutions Inc. FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 68258-3028_71576bbf-c1ec-4747-9e44-5b0923c96cbe 68258-3028 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090528 ANDA ANDA083312 Dispensing Solutions Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 68258-3029_dcfe1d2f-5f47-4d8d-9afb-b33d7425dff5 68258-3029 HUMAN PRESCRIPTION DRUG Next Choice levonorgestrel TABLET ORAL 20090904 ANDA ANDA078665 Dispensing Solutions, Inc. LEVONORGESTREL .75 mg/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC] E 20171231 68258-3030_342b7e19-49d6-4d0b-950a-cc00f4b79924 68258-3030 HUMAN PRESCRIPTION DRUG RELENZA zanamivir POWDER RESPIRATORY (INHALATION) 20021222 NDA NDA021036 Dispensing Solutions Inc. ZANAMIVIR 5 mg/1 Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA] E 20171231 68258-3031_e96f8cfb-3613-4b43-86eb-25efe9f2e601 68258-3031 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER ORAL; RESPIRATORY (INHALATION) 20010205 NDA NDA021077 Dispensing Solutions Inc. SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 250 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68258-3032_6f5962a5-487d-4d7d-a3eb-ec9d1e77caca 68258-3032 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, CHEWABLE ORAL 20091008 NDA NDA020830 Dispensing Solutions Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 68258-3033_6f5962a5-487d-4d7d-a3eb-ec9d1e77caca 68258-3033 HUMAN PRESCRIPTION DRUG SINGULAIR montelukast sodium TABLET, FILM COATED ORAL 20091008 NDA NDA020829 Dispensing Solutions Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 68258-3034_5fc17019-fe62-4eb2-96af-c79467313ed2 68258-3034 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET OCCLUSIVE DRESSING TECHNIQUE 19990715 NDA NDA021073 Dispensing Solutions, Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 68258-3035_f7d4a75c-bde1-4166-b6f8-70b8df2e7fe9 68258-3035 HUMAN PRESCRIPTION DRUG Mucinex D Guaifenesin and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20080208 NDA NDA021585 Dispensing Solutions Inc. GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 68258-3036_db169f6d-67b5-4328-9796-fdf7a57422be 68258-3036 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20040923 ANDA ANDA077253 Dispensing Solutions Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 68258-3037_0c9aea94-8edb-47c6-844d-27c0877f65c3 68258-3037 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20090722 NDA NDA020983 Dispensing Solutions Inc. ALBUTEROL SULFATE 108 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 68258-3040_10d4c04c-52d8-4692-b1a7-660ddb87dff7 68258-3040 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20041001 NDA NDA019813 Dispensing Solutions, Inc. FENTANYL 12 ug/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII E 20171231 68258-3042_f11aa988-f958-4f75-ab9b-89c24998faff 68258-3042 HUMAN PRESCRIPTION DRUG ENGERIX-B Hepatitis B Vaccine (Recombinant) INJECTION, SUSPENSION INTRAMUSCULAR 20090528 BLA BLA103239 Dispensing Solutions Inc. HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug/mL E 20171231 68258-3046_74567b8a-65a1-45be-8f6d-12261d9118ef 68258-3046 HUMAN PRESCRIPTION DRUG Nystatin nystatin CREAM TOPICAL 20060531 ANDA ANDA065315 Dispensing Solutions, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 68258-3051_3d465feb-afd8-4252-9c9e-3a4be10a6ebd 68258-3051 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19990212 NDA NDA050693 Dispensing Solutions, Inc. AZITHROMYCIN 1 g/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 68258-3053_d42fd817-f90a-4077-9db6-d7a7014d7aaa 68258-3053 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20070501 ANDA ANDA065259 Dispensing Solutions, Inc. CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 68258-3978_52eeaf00-babe-4eab-916f-47834846eec4 68258-3978 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20061110 ANDA ANDA087385 Dispensing Solutions, Inc. TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68258-3981_2ea41ae0-8f33-4902-bff1-606437d1da9c 68258-3981 HUMAN OTC DRUG New Terocin Methyl Salicylate, Capsaicin, and Menthol LOTION TOPICAL 20130313 OTC MONOGRAPH NOT FINAL part348 Dispensing Solutions, Inc. METHYL SALICYLATE; CAPSAICIN; MENTHOL 25; .025; 10 g/100mL; g/100mL; g/100mL E 20171231 68258-3984_77c9d2e7-6ce0-43dd-9537-a01d087e4d2d 68258-3984 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part348 Dispensing Solutions, Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 5; .0375 g/100g; g/100g; g/100g E 20171231 68258-3996_6b02cebe-eea9-464f-88eb-7c9db13b79fc 68258-3996 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine Ciclopirox Olamine CREAM TOPICAL 20091113 ANDA ANDA090273 Dispensing Solutions, Inc. CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] E 20171231 68258-3997_66802b4e-32f9-42a2-bb4a-b6aa7734b1e3 68258-3997 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20061018 ANDA ANDA077401 Dispensing Solutions, Inc. MOMETASONE FUROATE 1 mg/g E 20171231 68258-3998_3f184545-ae45-4fcb-a640-930401accb0b 68258-3998 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 Dispensing Solutions, Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 68258-4985_cf4f9c26-4eda-4269-a918-39e87c35beb7 68258-4985 HUMAN OTC DRUG Laxacin Docusate sodium and sennosides TABLET ORAL 20111001 OTC MONOGRAPH NOT FINAL part334 Dispensing Solutions, Inc. DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 E 20171231 68258-4987_8b728ea1-486f-4d61-b7c9-1ad8ce994dd4 68258-4987 HUMAN OTC DRUG Promolaxin Docusate sodium TABLET ORAL 20110415 OTC MONOGRAPH NOT FINAL part334 Dispensing Solutions, Inc. DOCUSATE SODIUM 100 mg/1 E 20171231 68258-5005_bb5b62e3-b229-4c86-ab21-8f21eeb82d50 68258-5005 HUMAN PRESCRIPTION DRUG Necon 777 777 norethindrone and ethinyl estradiol KIT 20021207 NDA NDA018985 Dispensing Solutions, Inc. E 20171231 68258-5230_5fc17019-fe62-4eb2-96af-c79467313ed2 68258-5230 HUMAN PRESCRIPTION DRUG Actos pioglitazone hydrochloride TABLET OCCLUSIVE DRESSING TECHNIQUE 19990715 NDA NDA021073 Dispensing Solutions, Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] E 20171231 68258-5948_951444e0-5267-469a-9243-00952fc6b90c 68258-5948 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 68258-5972_6c676e5d-352e-4ab5-bb2f-6aceec0e2f3e 68258-5972 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 68258-5973_6c676e5d-352e-4ab5-bb2f-6aceec0e2f3e 68258-5973 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 68258-5974_6c676e5d-352e-4ab5-bb2f-6aceec0e2f3e 68258-5974 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20020724 NDA NDA021402 Dispensing Solutions, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 68258-5978_cb3ae439-62fe-48c7-94de-a6e5f518a973 68258-5978 HUMAN PRESCRIPTION DRUG Prempro conjugated estrogens and medroxyprogesterone acetate TABLET, SUGAR COATED ORAL 20090921 NDA NDA020527 Dispensing Solutions, Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .3; 1.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 68258-5980_cb3ae439-62fe-48c7-94de-a6e5f518a973 68258-5980 HUMAN PRESCRIPTION DRUG Prempro conjugated estrogens and medroxyprogesterone acetate TABLET, SUGAR COATED ORAL 20090921 NDA NDA020527 Dispensing Solutions, Inc. ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .625; 2.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 68258-6010_69a5de8c-248f-4613-b495-ea310d23fdfd 68258-6010 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20081013 ANDA ANDA078955 Dispensing Solutions, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 68258-6019_3334d650-acaf-4ae0-bfac-25a6df21476f 68258-6019 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, EXTENDED RELEASE ORAL 20090804 ANDA ANDA076862 Dispensing Solutions, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 68258-6023_1cae4261-d794-41d6-b8b1-1555852cbbbd 68258-6023 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080618 ANDA ANDA077900 Dispensing Solutions, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 68258-6024_0993e676-7476-48e9-8bbb-ee393783ad9f 68258-6024 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Dispensing Solutions, Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 68258-6031_649fa3d9-0775-4a82-81f8-39c49f9c47f8 68258-6031 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20100406 ANDA ANDA090528 Dispensing Solutions, Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 68258-6032_bff5e40f-d32d-4ff9-8735-8c326b75fe92 68258-6032 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100629 NDA NDA020381 Dispensing Solutions, Inc. NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 68258-6033_c036bb97-36e7-42d0-a807-2f30a7503ca7 68258-6033 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20040115 ANDA ANDA076670 Dispensing Solutions, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 68258-6034_2990467e-9e2d-4a9d-ba40-64675ae2a5e5 68258-6034 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20081001 ANDA ANDA074501 Dispensing Solutions, Inc. NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 68258-6036_8e2b971c-d0c4-4016-b62f-08488a6ec166 68258-6036 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20051117 ANDA ANDA077321 Dispensing Solutions, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 68258-6037_569ac5fc-e35b-4e0e-97d1-9327a1c1b511 68258-6037 HUMAN PRESCRIPTION DRUG Niaspan Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 19970728 NDA NDA020381 Dispensing Solutions, Inc. NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 68258-6040_17c70627-857f-40ad-836e-2b15336bd8d6 68258-6040 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078235 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 68258-6041_1667ff8f-da0d-4026-8ba5-e1444f57bbd4 68258-6041 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Dispensing Solutions, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 68258-6042_1667ff8f-da0d-4026-8ba5-e1444f57bbd4 68258-6042 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Dispensing Solutions, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 68258-6043_1667ff8f-da0d-4026-8ba5-e1444f57bbd4 68258-6043 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Dispensing Solutions, Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 68258-6044_1667ff8f-da0d-4026-8ba5-e1444f57bbd4 68258-6044 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Dispensing Solutions, Inc. ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 68258-6046_4eceff12-b13c-429c-b859-d9c0cfddf9f5 68258-6046 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Dispensing Solutions, Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 68258-6047_85ac20d9-9737-449c-9929-e84c649f5a00 68258-6047 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20110101 ANDA ANDA074787 Dispensing Solutions, Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 68258-6053_9dd376a1-3a4f-4e38-ae5a-0f2ae7c310f4 68258-6053 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Dispensing Solutions, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 68258-6056_5ce44a1d-f91e-4cd8-a51c-6993bbb9e56e 68258-6056 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Dispensing Solutions, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 68258-6095_c2f46e16-af36-41ea-a860-47f23b9612b4 68258-6095 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Dispensing Solutions, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 68258-6096_c2f46e16-af36-41ea-a860-47f23b9612b4 68258-6096 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20120921 NDA AUTHORIZED GENERIC NDA020818 Dispensing Solutions, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 68258-6099_d5178c9e-f740-42a9-a93d-3f554095a1da 68258-6099 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20040610 ANDA ANDA076161 Dispensing Solutions, Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 68258-6100_67029d98-f499-4123-a1e9-6422f0e72c0d 68258-6100 HUMAN PRESCRIPTION DRUG Trandolapril Trandolapril TABLET ORAL 20070207 ANDA ANDA077489 Dispensing Solutions, Inc. TRANDOLAPRIL 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 68258-6106_649f5bc7-7ee3-42bd-84b0-8a0650a9582c 68258-6106 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril Sodium TABLET ORAL 20040423 ANDA ANDA076483 Dispensing Solutions, Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 68258-6969_21fa3398-430e-465d-8ef4-6b06d781fda5 68258-6969 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130321 ANDA ANDA078946 Dispensing Solutions, Inc. HYDROCHLOROTHIAZIDE; VALSARTAN 25; 320 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 68258-6972_1b1be459-a727-487a-aefd-f3c3757b6cc9 68258-6972 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Dispensing Solutions, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 68258-6973_1b1be459-a727-487a-aefd-f3c3757b6cc9 68258-6973 HUMAN PRESCRIPTION DRUG Diovan HCT valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 19980306 NDA NDA020818 Dispensing Solutions, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 68258-6992_cbd5e14a-1476-490d-8ab4-308ea767b51f 68258-6992 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Dispensing Solutions, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 68258-6993_cbd5e14a-1476-490d-8ab4-308ea767b51f 68258-6993 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20111201 ANDA ANDA076477 Dispensing Solutions, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 68258-7001_865ab1fc-2dc9-43bd-8c7e-0ad3763b9dcc 68258-7001 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED OCCLUSIVE DRESSING TECHNIQUE 20000207 ANDA ANDA075584 Dispensing Solutions, Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 68258-7013_e42a2997-38cb-4a35-be8b-b7a4bc9a0075 68258-7013 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20070228 ANDA ANDA077797 Dispensing Solutions, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 68258-7047_fa5746b6-3e07-423b-8fcb-660fd1404475 68258-7047 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Dispensing Solutions, Inc. PREGABALIN 150 mg/1 CV E 20171231 68258-7048_abf41383-30a2-43ec-b4d3-1c17836b8900 68258-7048 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Dispensing Solutions, Inc. ESZOPICLONE 2 mg/1 CIV E 20171231 68258-7049_abf41383-30a2-43ec-b4d3-1c17836b8900 68258-7049 HUMAN PRESCRIPTION DRUG Lunesta ESZOPICLONE TABLET, COATED ORAL 20050404 NDA NDA021476 Dispensing Solutions, Inc. ESZOPICLONE 3 mg/1 CIV E 20171231 68258-7056_c5e7e4ab-39fc-4095-818e-c1e43fb1d77b 68258-7056 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090413 ANDA ANDA090278 Dispensing Solutions Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68258-7067_e8cf3fb8-27c3-4e9f-8db4-8cc6d93566e2 68258-7067 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20070613 ANDA ANDA077715 Dispensing Solutions, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 68258-7068_212b3aaa-746d-4702-9789-8fee4e9be397 68258-7068 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Dispensing Solutions, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 68258-7077_1a577f08-1a85-45a0-81b9-265be154dc66 68258-7077 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 19861117 ANDA ANDA071207 Dispensing Solutions, Inc. HALOPERIDOL 1 mg/1 Typical Antipsychotic [EPC] E 20171231 68258-7087_8df6cacc-6679-47e3-98cb-8e9ab984421a 68258-7087 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20010328 ANDA ANDA074253 Dispensing Solutions, Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 E 20171231 68258-7089_39ab0a80-121a-41ac-94b8-de8165fbd7b0 68258-7089 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Dispensing Solutions, Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 68258-7090_32a1e443-4d13-47ea-a3fb-85e4de4d8845 68258-7090 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19970623 NDA NDA020592 Dispensing Solutions, Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 68258-7091_32a1e443-4d13-47ea-a3fb-85e4de4d8845 68258-7091 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Dispensing Solutions, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 68258-7092_32a1e443-4d13-47ea-a3fb-85e4de4d8845 68258-7092 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 19961001 NDA NDA020592 Dispensing Solutions, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 68258-7093_32a1e443-4d13-47ea-a3fb-85e4de4d8845 68258-7093 HUMAN PRESCRIPTION DRUG Zyprexa Olanzapine TABLET ORAL 20000110 NDA NDA020592 Dispensing Solutions, Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] E 20171231 68258-7095_2e7299de-62ca-4372-94ce-62f5621a930f 68258-7095 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Dispensing Solutions, Inc. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 68258-7096_2e7299de-62ca-4372-94ce-62f5621a930f 68258-7096 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Dispensing Solutions, Inc. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] E 20171231 68258-7100_86de2f42-f64d-4801-98a8-b879a4779840 68258-7100 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20071101 NDA NDA013217 Dispensing Solutions, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 68258-7103_9a4bcae1-f67a-443e-a946-8e92cebbc01f 68258-7103 HUMAN PRESCRIPTION DRUG ZOMIG Zolmitriptan TABLET ORAL 20100518 NDA NDA020768 Dispensing Solutions, Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 68258-7114_c89655ee-1e40-4aea-838a-31efde68e839 68258-7114 HUMAN PRESCRIPTION DRUG sumatriptan succinate sumatriptan succinate TABLET, FILM COATED ORAL 20090810 ANDA ANDA078295 Dispensing Solutions, Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 68258-7126_e8cf3fb8-27c3-4e9f-8db4-8cc6d93566e2 68258-7126 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride XL Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20081126 ANDA ANDA077715 Dispensing Solutions, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 68258-7128_c36c58df-fc65-4072-ac8c-3b168c2bcd1b 68258-7128 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120911 ANDA ANDA078766 Dispensing Solutions, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 68258-7150_666a7201-2cec-49a0-b590-8e9866958b0b 68258-7150 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYDROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 Dispensing Solutions, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 68258-7152_f546cd57-6d18-4096-a519-c12c62ec817c 68258-7152 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Dispensing Solutions, Inc. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 68258-7153_f546cd57-6d18-4096-a519-c12c62ec817c 68258-7153 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Dispensing Solutions, Inc. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] E 20171231 68258-7154_f546cd57-6d18-4096-a519-c12c62ec817c 68258-7154 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20111024 ANDA ANDA076000 Dispensing Solutions, Inc. OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 68258-7156_29d8c0dd-978b-49e3-be25-8e80b1ae0823 68258-7156 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Dispensing Solutions, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68258-7157_1638838c-d5e5-46f3-b5f1-f8332b3beb42 68258-7157 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100408 ANDA ANDA078866 Dispensing Solutions, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] E 20171231 68258-7159_3883ec95-e22d-4190-aa4a-c85b5cbc11f6 68258-7159 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20090327 ANDA ANDA090278 Dispensing Solutions, Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68258-7160_e4a5719d-bb90-435d-a9ef-604023aae517 68258-7160 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19970911 ANDA ANDA040218 Dispensing Solutions, Inc. AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] E 20171231 68258-7162_ec4d59ce-00e6-4dcd-a59b-ff74d334eec4 68258-7162 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride Ropinirole Hydrochloride TABLET, FILM COATED ORAL 20090918 ANDA ANDA090429 Dispensing Solutions, Inc. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 68258-7163_c5dd57e1-930a-4942-97ac-2b63f1d9a7f2 68258-7163 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Dispensing Solutions, Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 68258-7980_04ac4476-c8ce-4c16-a8d5-484492d52c5d 68258-7980 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20041230 NDA NDA021724 Dispensing Solutions, Inc. PREGABALIN 75 mg/1 CV E 20171231 68258-7981_d0d3dac4-a8c8-4c05-abfa-aad2ee2f41f6 68258-7981 HUMAN PRESCRIPTION DRUG modafinil modafinil TABLET ORAL 20120329 NDA AUTHORIZED GENERIC NDA020717 Dispensing Solutions, Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV E 20171231 68258-7991_4b7832cb-8420-47b0-b947-363aa54e2ca1 68258-7991 HUMAN OTC DRUG Good Sense Nicotine Nicotine Polacrilex LOZENGE ORAL 20091128 ANDA ANDA077007 Dispensing Solutions, Inc. NICOTINE 2 mg/1 E 20171231 68258-7992_40855932-0f9c-4ee0-96a5-4512c6ba9d66 68258-7992 HUMAN OTC DRUG good sense nicotine Nicotine Polacrilex LOZENGE ORAL 20061227 ANDA ANDA077007 Dispensing Solutions, Inc. NICOTINE 4 mg/1 E 20171231 68258-8000_7c6d5ac1-5bee-4c72-8240-10a7f2568260 68258-8000 HUMAN OTC DRUG Rugby Nasal Decongestant Nasal Decongestant Pseudoephedrine Hydrochloride LIQUID ORAL 19990726 OTC MONOGRAPH FINAL part341 Dispensing Solutions, Inc. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/5mL E 20171231 68258-8001_fa09c411-6ac1-4d89-8eaa-7e8810bba033 68258-8001 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP OCCLUSIVE DRESSING TECHNIQUE 19980130 ANDA ANDA074749 Dispensing Solutions, Inc. ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 68258-8899_5d8213bc-800b-4e52-af9e-3ba3e5f2650c 68258-8899 HUMAN PRESCRIPTION DRUG NovoLog insulin aspart INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20030122 NDA NDA020986 Dispensing Solutions, Inc. INSULIN ASPART 100 [iU]/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 68258-8900_02ad0855-49aa-44a6-80ef-e8a0be13eec2 68258-8900 HUMAN OTC DRUG good neighbor pharmacy eye itch relief Ketotifen Fumarate SOLUTION OPHTHALMIC 20101113 ANDA ANDA077958 Dispensing Solutions, Inc. KETOTIFEN FUMARATE .25 mg/mL E 20171231 68258-8902_1876c780-20ee-4f51-91a1-f7ae376a2dda 68258-8902 HUMAN OTC DRUG Good Neighbor Pharmacy Ibuprofen Cold and Sinus Ibuprofen, Pseudoephedrine Hydrochloride TABLET ORAL 20011015 ANDA ANDA074567 Dispensing Solutions, Inc. IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 200; 30 mg/1; mg/1 E 20171231 68258-8903_af60c3f8-367c-431b-bf14-c9927b2abdce 68258-8903 HUMAN PRESCRIPTION DRUG KENALOG-10 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL 20090601 NDA NDA012041 Dispensing Solutions, Inc. TRIAMCINOLONE ACETONIDE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68258-8904_ef2f000e-865b-4a31-831f-eef6ca717f7a 68258-8904 HUMAN OTC DRUG Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate SOLUTION ORAL 20061001 OTC MONOGRAPH FINAL part341 Dispensing Solutions, Inc. GUAIFENESIN; CODEINE PHOSPHATE 100; 10 mg/5mL; mg/5mL CV E 20171231 68258-8905_e606d0c5-b79d-4687-8d3c-24a0c4b5f101 68258-8905 HUMAN OTC DRUG good sense tussin dm cough and chest congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 19940920 OTC MONOGRAPH FINAL part341 Dispensing Solutions, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 68258-8907_2f0453e0-6c62-4ee0-94d8-5c354adb562d 68258-8907 HUMAN OTC DRUG Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Cetirizine HCl, Pseudoephedrine HCl TABLET, EXTENDED RELEASE ORAL 20080410 ANDA ANDA077170 Dispensing Solutions, Inc. CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 E 20171231 68258-8910_b530e3ad-d9c7-4946-b19e-eef2ca16e407 68258-8910 HUMAN PRESCRIPTION DRUG BICILLIN CR penicillin G benzathine and penicillin G procaine INJECTION, SUSPENSION INTRAMUSCULAR 19530518 NDA NDA050138 Dispensing Solutions, Inc. PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE 600000; 600000 [iU]/2mL; [iU]/2mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 68258-8912_c319ee15-43a9-4864-a4c1-40ffb50d9e5a 68258-8912 VACCINE HAVRIX Hepatitis A Vaccine INJECTION, SUSPENSION INTRAMUSCULAR 20070413 BLA BLA103475 Dispensing Solutions, Inc. HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 1440 [iU]/mL Inactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] E 20171231 68258-8922_478e24f9-c2b6-4b8e-bfff-73f19b671e86 68258-8922 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20081119 ANDA ANDA077519 Dispensing Solutions, Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68258-8961_198f20a2-218e-4a0f-a4c1-ae7c3b62e1c6 68258-8961 HUMAN PRESCRIPTION DRUG SEREVENT DISKUS salmeterol xinafoate POWDER, METERED ORAL; RESPIRATORY (INHALATION) 19971125 NDA NDA020692 Dispensing Solutions, Inc. SALMETEROL XINAFOATE 50 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 68258-8973_8c80bd8d-d5cf-41a5-8391-0a2fc4a76dee 68258-8973 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride Midazolam Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110502 ANDA ANDA075857 Dispensing Solutions, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 68258-8976_309e27fc-3503-4307-880c-2d9492423870 68258-8976 HUMAN PRESCRIPTION DRUG Xalatan latanoprost SOLUTION OPHTHALMIC 19950320 NDA NDA020597 Dispensing Solutions, Inc. LATANOPROST 50 ug/mL Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient] E 20171231 68258-8977_082bc713-cea6-4af8-b2be-65622cb897d0 68258-8977 HUMAN PRESCRIPTION DRUG Levemir insulin detemir IMPLANT SOFT TISSUE 20060327 NDA NDA021536 Dispensing Solutions, Inc. INSULIN DETEMIR 14.2 mg/mL Insulin [Chemical/Ingredient],Insulin Analog [EPC] E 20171231 68258-8978_d9c34849-a809-4a5c-884d-b877006a7e3a 68258-8978 HUMAN PRESCRIPTION DRUG Cefazolin cefazolin sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20090201 ANDA ANDA063207 Dispensing Solutions, Inc. CEFAZOLIN SODIUM 1 g/3mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 68258-8981_b5c3b5fc-3d14-4da6-8b9e-dc04ba5cab51 68258-8981 HUMAN PRESCRIPTION DRUG Midazolam Hydrochloride MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20110503 ANDA ANDA075293 Dispensing Solutions, Inc. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 68258-8987_85f672a6-a6bb-40af-944c-b7a2d3a5af74 68258-8987 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Dispensing Solutions, Inc. PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68275-320_2e956093-0266-4a5a-8926-610a8ff7cdfd 68275-320 HUMAN PRESCRIPTION DRUG Colocynthis Homaccord GNAPHALIUM and CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED INJECTION INTRADERMAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20090909 UNAPPROVED HOMEOPATHIC JENAHEXAL PHARMA GMBH GNAPHALIUM; GNAPHALIUM; GNAPHALIUM; GNAPHALIUM; CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED; CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED; CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED; CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED 3; 10; 30; 200; 4; 10; 30; 200 [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL; [hp_X]/1.1mL E 20171231 68276-004_fe6a7986-2443-4e19-a830-42b4aa604e13 68276-004 HUMAN OTC DRUG Bouton Eye Wash Water RINSE OPHTHALMIC 20100115 OTC MONOGRAPH FINAL part349 Aaxis Pacific WATER 98.6 mL/100mL E 20171231 68276-005_80984d7b-efbd-452b-aea4-8f1d83d5ee25 68276-005 HUMAN OTC DRUG Salinaax Eye Wash and Skin Flush Water RINSE OPHTHALMIC 20110311 OTC MONOGRAPH FINAL part349 Aaxis Pacific WATER 98.6 mL/100mL E 20171231 68276-006_60803d8a-3927-4e56-9af4-88221b9ebc3d 68276-006 HUMAN OTC DRUG Salinaax Eye Wash Water RINSE OPHTHALMIC 20100618 OTC MONOGRAPH FINAL part349 Aaxis Pacific WATER 98.6 mL/100mL N 20181231 68276-007_7c51e322-5734-41b9-9c78-ce77634207bf 68276-007 HUMAN OTC DRUG SL Eye Wash with Preservative Water IRRIGANT TOPICAL 20170815 OTC MONOGRAPH FINAL part349 Aaxis Pacific dba Aaxis Pharmaceuticals WATER 98 mL/100mL N 20181231 68289-003_2350d1e3-187a-4cb7-94f5-0c66d7e651f9 68289-003 HUMAN PRESCRIPTION DRUG Cefaclor cefaclor CAPSULE ORAL 20070304 ANDA ANDA065350 Jazeera Pharmaceutical CEFACLOR 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68289-004_2350d1e3-187a-4cb7-94f5-0c66d7e651f9 68289-004 HUMAN PRESCRIPTION DRUG Cefaclor cefaclor CAPSULE ORAL 20070304 ANDA ANDA065350 Jazeera Pharmaceutical CEFACLOR 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68289-006_5afe6d38-8183-4246-8cff-6287d8c1d144 68289-006 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil TABLET, FILM COATED ORAL 20060331 ANDA ANDA065260 Jazeera Pharmaceutical CEFADROXIL 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68289-008_24fc53ef-d9ef-401a-8bbe-3fc0d76a6cf8 68289-008 HUMAN PRESCRIPTION DRUG Cephalexin USP Cephalexin SUSPENSION ORAL 20090901 ANDA ANDA065444 Jazeera Pharmaceutical CEPHALEXIN ANHYDROUS 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68289-009_24fc53ef-d9ef-401a-8bbe-3fc0d76a6cf8 68289-009 HUMAN PRESCRIPTION DRUG Cephalexin USP Cephalexin SUSPENSION ORAL 20090901 ANDA ANDA065444 Jazeera Pharmaceutical CEPHALEXIN ANHYDROUS 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68289-013_f219e051-99c0-4142-8bd8-269b049e9722 68289-013 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20121128 ANDA ANDA091036 Jazeera Pharmaceutical CEFADROXIL 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68289-014_f219e051-99c0-4142-8bd8-269b049e9722 68289-014 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil POWDER, FOR SUSPENSION ORAL 20121128 ANDA ANDA091036 Jazeera Pharmaceutical CEFADROXIL 500 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68289-051_9818cae1-268b-4c1f-8ab2-c5d33b574d01 68289-051 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20060207 ANDA ANDA065311 Jazeera Pharmaceutical CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68304-141_374a861e-f2b7-499e-b3aa-783768cb9630 68304-141 HUMAN OTC DRUG Supreme Chloroxylenol SOAP TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part333A Brookmeade Hardware & Supply Co. CHLOROXYLENOL 3.75 mg/mL E 20171231 68306-101_33c89e2f-3332-4e25-ac2c-cdcc0acae918 68306-101 HUMAN OTC DRUG Avant Original Instant Hand Sanitizer Alcohol GEL TOPICAL 20101005 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC ALCOHOL 60 mL/100mL E 20171231 68306-104_3b716461-0dfd-42f9-8e5c-d4d12fe05f70 68306-104 HUMAN OTC DRUG Avant EX Alcohol GEL TOPICAL 20100515 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC ALCOHOL 70 mL/100mL N 20181231 68306-105_db364ab9-aea4-41e8-9825-08cf7abd1bd6 68306-105 HUMAN OTC DRUG Aterra Antibacterial Hand Wash Triclosan LIQUID TOPICAL 20101118 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC TRICLOSAN 3 mL/1000mL N 20181231 68306-106_e1c93cb4-1416-47f1-b898-e72031190863 68306-106 HUMAN OTC DRUG Avant Original - Fragrance Free Alcohol GEL TOPICAL 20100515 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC ALCOHOL 60 mL/100mL N 20181231 68306-108_21f2aaae-93f3-4d86-bb43-0ac3035d92c4 68306-108 HUMAN OTC DRUG Aterra Antibacterial Foaming Hand Wash Triclosan SOAP TOPICAL 20101115 OTC MONOGRAPH NOT FINAL part333E B4 Ventures, LLC TRICLOSAN 3 mL/1000mL N 20181231 68306-109_d301ef51-4da7-4ecb-a9c2-a114f5086532 68306-109 HUMAN OTC DRUG Avant Foaming Hand Sanitizer Alcohol LIQUID TOPICAL 20101208 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC ALCOHOL 62 mL/100mL N 20181231 68306-112_6369cc51-4a87-41ba-a0c7-d4e14091414a 68306-112 HUMAN OTC DRUG Avant Alcohol-Free Instant Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part333E B4 Ventures, LLC BENZALKONIUM CHLORIDE 1 g/1000mL N 20181231 68306-113_8102e2ec-05b8-4a45-9a15-93370687b1cc 68306-113 HUMAN OTC DRUG Aterra E-2 Sanitizing Foam Hand Wash Benzalkonium Chloride SOAP TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E B4 Ventures, LLC BENZALKONIUM CHLORIDE 25 mL/1000mL N 20181231 68306-114_48489051-fba8-49d1-94e9-6027a615b77b 68306-114 HUMAN OTC DRUG Avant Eco-Premium Instant Hand Sanitizer Alcohol GEL TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part333E B4 Ventures LLC ALCOHOL 70 mL/100mL N 20181231 68308-020_83e38e30-cd7a-403d-bad4-967860250938 68308-020 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20140612 ANDA ANDA204092 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68308-108_c4085244-f05c-4af2-a096-ec9809dc55c7 68308-108 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68308-110_c4085244-f05c-4af2-a096-ec9809dc55c7 68308-110 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68308-111_c4085244-f05c-4af2-a096-ec9809dc55c7 68308-111 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68308-112_c4085244-f05c-4af2-a096-ec9809dc55c7 68308-112 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68308-115_82d97548-6366-4bbe-b167-ee0a4a716f8a 68308-115 HUMAN PRESCRIPTION DRUG Methamphetamine Hydrochloride METHAMPHETAMINE HYDROCHLORIDE TABLET ORAL 20100426 ANDA ANDA091189 Mayne Pharma Inc. METHAMPHETAMINE HYDROCHLORIDE 5 mg/1 Amphetamine Anorectic [EPC],Amphetamines [Chemical/Ingredient],Appetite Suppression [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE] CII N 20181231 68308-120_c4085244-f05c-4af2-a096-ec9809dc55c7 68308-120 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68308-145_ecd0d70e-0fd5-4484-b90c-60c232606c13 68308-145 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20120731 ANDA ANDA203107 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68308-152_1a3b8466-7c88-45aa-8662-f9272cdd2189 68308-152 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20040715 ANDA ANDA065203 Mayne Pharma Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 68308-219_62978ead-0ed5-94cc-e053-2991aa0af96f 68308-219 HUMAN PRESCRIPTION DRUG Esgic butalbital, acetaminophen and caffeine CAPSULE ORAL 20140501 ANDA ANDA089007 Mayne Pharma Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20191231 68308-220_60111dc4-996e-83e9-e053-2991aa0adc98 68308-220 HUMAN PRESCRIPTION DRUG Esgic butalbital, acetaminophen and caffeine TABLET ORAL 20140501 ANDA ANDA089175 Mayne Pharma Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68308-221_6419a937-9312-79c5-e053-2991aa0aba63 68308-221 HUMAN PRESCRIPTION DRUG LORCET Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 20180331 ANDA ANDA090118 Mayne Pharma Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20191231 68308-222_6419a937-9312-79c5-e053-2991aa0aba63 68308-222 HUMAN PRESCRIPTION DRUG LORCET PLUS Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 20180331 ANDA ANDA090118 Mayne Pharma Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20191231 68308-223_6419a937-9312-79c5-e053-2991aa0aba63 68308-223 HUMAN PRESCRIPTION DRUG LORCET HD Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 20180331 ANDA ANDA090118 Mayne Pharma Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20191231 68308-224_6419ad1b-82a5-7950-e053-2991aa0ad808 68308-224 HUMAN PRESCRIPTION DRUG LORCET Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 20180331 ANDA ANDA090118 Mayne Pharma HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 68308-225_6419ad1b-82a5-7950-e053-2991aa0ad808 68308-225 HUMAN PRESCRIPTION DRUG LORCET PLUS Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 20180331 ANDA ANDA090118 Mayne Pharma HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 68308-226_6419ad1b-82a5-7950-e053-2991aa0ad808 68308-226 HUMAN PRESCRIPTION DRUG LORCET HD Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20140401 20180331 ANDA ANDA090118 Mayne Pharma HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 68308-250_ff397bd8-e808-4908-b4ca-42cdf024e73a 68308-250 HUMAN PRESCRIPTION DRUG erythromycin erythromycin CAPSULE, DELAYED RELEASE PELLETS ORAL 20130729 NDA AUTHORIZED GENERIC NDA050536 Mayne Pharma Inc. ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68308-312_6d6c897f-5514-4e8f-ad70-13768bf3490a 68308-312 HUMAN PRESCRIPTION DRUG Butalbital, Aspirin, Caffeine, and Codeine Phosphate Butalbital, Aspirin, Caffeine, and Codeine Phosphate CAPSULE ORAL 20151030 ANDA ANDA203335 Mayne Pharma Inc. BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 68308-325_e572ad8e-5e6d-4b5a-8934-77b0497e3495 68308-325 HUMAN PRESCRIPTION DRUG Foltabs 800 Vitamins Tablets TABLET ORAL 20090101 20190630 UNAPPROVED DRUG OTHER Mayne Pharma Inc PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN 115; 800; 115 mg/1; ug/1; ug/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 68308-326_baf8cfad-1ff4-4baf-9179-3dad9d36fbb0 68308-326 HUMAN PRESCRIPTION DRUG FaBB Tablets Vitamins Tablets TABLET ORAL 20090101 UNAPPROVED DRUG OTHER Midlothian Laboratories PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN 25; 2.2; 1 mg/1; mg/1; mg/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] E 20171231 68308-405_28ac5a7d-9a25-4194-86bd-ca89cc0a1373 68308-405 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 68308-475_28ac5a7d-9a25-4194-86bd-ca89cc0a1373 68308-475 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 68308-480_28ac5a7d-9a25-4194-86bd-ca89cc0a1373 68308-480 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 68308-505_c4085244-f05c-4af2-a096-ec9809dc55c7 68308-505 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride TABLET ORAL 20110228 ANDA ANDA091313 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68308-554_d48e085e-dc61-4e1f-88f2-ccf1e9110bee 68308-554 HUMAN PRESCRIPTION DRUG Zebutal butalbital, acetaminophen and caffeine CAPSULE ORAL 20131226 ANDA ANDA089007 Mayne Pharma Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68308-710_c80952d9-f37d-48f6-89ee-db74fc7d746e 68308-710 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20130708 NDA AUTHORIZED GENERIC NDA050795 Mayne Pharma Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68308-715_c80952d9-f37d-48f6-89ee-db74fc7d746e 68308-715 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20130708 NDA AUTHORIZED GENERIC NDA050795 Mayne Pharma Inc. DOXYCYCLINE HYCLATE 150 mg/1 N 20181231 68308-716_c80952d9-f37d-48f6-89ee-db74fc7d746e 68308-716 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20160201 NDA AUTHORIZED GENERIC NDA050795 Mayne Pharma Inc. DOXYCYCLINE HYCLATE 200 mg/1 N 20181231 68308-775_c80952d9-f37d-48f6-89ee-db74fc7d746e 68308-775 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, DELAYED RELEASE ORAL 20130708 NDA AUTHORIZED GENERIC NDA050795 Mayne Pharma Inc. DOXYCYCLINE HYCLATE 75 mg/1 N 20181231 68308-840_28ac5a7d-9a25-4194-86bd-ca89cc0a1373 68308-840 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 68308-841_28ac5a7d-9a25-4194-86bd-ca89cc0a1373 68308-841 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 68308-842_28ac5a7d-9a25-4194-86bd-ca89cc0a1373 68308-842 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 68308-843_28ac5a7d-9a25-4194-86bd-ca89cc0a1373 68308-843 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone Hydrochloride and Acetaminophen TABLET ORAL 20081216 ANDA ANDA090177 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 68308-845_25317902-96bb-4fa4-ac0c-35e362b41935 68308-845 HUMAN PRESCRIPTION DRUG Oxycodone and Aspirin Oxycodone Hydrochloride and Aspirin TABLET ORAL 20110502 ANDA ANDA091670 Mayne Pharma Inc. OXYCODONE HYDROCHLORIDE; ASPIRIN 4.8355; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE] CII N 20181231 68327-002_45f8e99c-9a20-44ad-bf4b-1cd53d0fb2e5 68327-002 HUMAN OTC DRUG Natural FX OCTINOXATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3.4; 2.2; .9 g/100mL; g/100mL; g/100mL N 20181231 68327-003_d9d95792-6a64-4b61-9fe7-10ca55c7f0c4 68327-003 HUMAN OTC DRUG Skin Tint FX OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110920 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 6.5; 3.5; 2.1; 5.5; 5.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68327-004_bc82ac98-ca84-407d-98fc-af300754202e 68327-004 HUMAN OTC DRUG Mint Glaze FX OCTINOXATE, OXYBENZONE OINTMENT TOPICAL 20100409 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. OCTINOXATE; OXYBENZONE 7.5; 2.5 g/100mL; g/100mL N 20181231 68327-005_048bb7e5-b132-4b36-8274-8c8db1c1fb07 68327-005 HUMAN OTC DRUG BritePrep FX OCTOCRYLENE, OCTINOXATE, OXYBENZONE,TITANIUM DIOXIDE CREAM TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. OCTOCRYLENE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 9; 7.5; 3; 1.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68327-006_05ed1245-f8fd-45d1-85ad-5dad98bf568e 68327-006 HUMAN OTC DRUG ClearPrep FX SALICYLIC ACID GEL TOPICAL 20110701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID 1 g/100mL N 20181231 68327-010_20b2c5ff-19eb-4427-9d33-38c18054d639 68327-010 HUMAN OTC DRUG COVER FX TOTAL COVER FOUNDATION SPF 30 OCTOCRYLENE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE 8.5; 5; 3 mg/g; mg/g; mg/g N 20181231 68327-030_d2b5e13b-7620-4c3e-8db9-3419a178b5a5 68327-030 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer N X-Light SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g N 20181231 68327-031_d2b5e13b-7620-4c3e-8db9-3419a178b5a5 68327-031 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer N Light SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g N 20181231 68327-032_d2b5e13b-7620-4c3e-8db9-3419a178b5a5 68327-032 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer N Medium SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g N 20181231 68327-033_d2b5e13b-7620-4c3e-8db9-3419a178b5a5 68327-033 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer N Med-Deep SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g N 20181231 68327-034_d2b5e13b-7620-4c3e-8db9-3419a178b5a5 68327-034 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer N Deep SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g N 20181231 68327-035_d2b5e13b-7620-4c3e-8db9-3419a178b5a5 68327-035 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer N X-Deep SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g N 20181231 68327-036_cfbda8da-daa9-4fb1-978f-2e6d310b51f0 68327-036 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer G Light SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g N 20181231 68327-037_cfbda8da-daa9-4fb1-978f-2e6d310b51f0 68327-037 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer G Medium SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g N 20181231 68327-038_31e9f40b-e8e3-4447-b448-691789fb7281 68327-038 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer P Light SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g N 20181231 68327-039_31e9f40b-e8e3-4447-b448-691789fb7281 68327-039 HUMAN OTC DRUG Cover Fx Blemish Treatment Concealer P Medium SALICYLIC ACID STICK TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Cover FX Skin Care, Inc. SALICYLIC ACID .025 g/2.5g N 20181231 68327-040_8531dad5-2841-45d2-8da3-0fa69247e1e1 68327-040 HUMAN OTC DRUG Cover FX Mattifying Primer with Anti-Acne Treatment Salicylic Acid GEL TOPICAL 20150301 OTC MONOGRAPH FINAL part333D Cover FX Skin Care Inc SALICYLIC ACID 1 g/100mL N 20181231 68327-071_b4362fcb-a998-412e-b29a-9bf9e76700e1 68327-071 HUMAN OTC DRUG Cover FX Clear Cover Invisible Sunscreen Broad Spectrum SPF 30 Sunscreen GEL TOPICAL 20160527 OTC MONOGRAPH NOT FINAL part352 Cover FX Skin Care Inc. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 10; 5; 3; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68327-072_c27c2cb0-5988-477e-a5cb-89ac4d257d77 68327-072 HUMAN OTC DRUG Cover FX Mattifying Prime and Set Salicylic Acid KIT 20170601 OTC MONOGRAPH FINAL part333D Cover FX Skin Care Inc N 20181231 68330-001_4e15b344-d5b4-415b-8ce1-a856dc37a13c 68330-001 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080715 ANDA ANDA065294 Cephazone Pharma LLC CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 68330-002_4e15b344-d5b4-415b-8ce1-a856dc37a13c 68330-002 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080715 ANDA ANDA065294 Cephazone Pharma LLC CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 68330-003_4e15b344-d5b4-415b-8ce1-a856dc37a13c 68330-003 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080715 ANDA ANDA065294 Cephazone Pharma LLC CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 68330-004_4e15b344-d5b4-415b-8ce1-a856dc37a13c 68330-004 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080715 ANDA ANDA065294 Cephazone Pharma LLC CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 68330-005_4e15b344-d5b4-415b-8ce1-a856dc37a13c 68330-005 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080715 ANDA ANDA065294 Cephazone Pharma LLC CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 68330-006_4e15b344-d5b4-415b-8ce1-a856dc37a13c 68330-006 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20080715 ANDA ANDA065294 Cephazone Pharma LLC CEFTRIAXONE SODIUM 2 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 68343-001_4fab9043-bee6-09e3-e054-00144ff8d46c 68343-001 HUMAN OTC DRUG Dermisa Skin Fade Hydroquinone Padimate O CREAM TOPICAL 20110915 OTC MONOGRAPH NOT FINAL part358A Montani Cosmetics Inc HYDROQUINONE; PADIMATE O 2; .6 g/100g; g/100g N 20181231 68343-002_bdf1a88b-bee3-4fd1-b9e4-46d626599200 68343-002 HUMAN OTC DRUG Dermisa CLEAR SKIN Benzoyl Peroxide CREAM TOPICAL 20130228 OTC MONOGRAPH NOT FINAL part333D Montani Cosmetics Inc BENZOYL PEROXIDE 5 g/100g N 20181231 68343-003_58ece525-b62b-fa51-e053-2991aa0a35ef 68343-003 HUMAN OTC DRUG Dermisa SUNSCREEN SPF 55 BROAD SPECTRUM Octinoxate, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20170908 OTC MONOGRAPH FINAL part352 Montani Cosmetics Inc OCTOCRYLENE; AVOBENZONE; OXYBENZONE; OCTISALATE; HOMOSALATE 2.75; 3; 6; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68345-100_d73bfd7c-502e-4f10-a0bb-e625deb2b853 68345-100 HUMAN PRESCRIPTION DRUG Repara Silver Nitrate Applicators Silver Nitrate STICK TOPICAL 20121026 UNAPPROVED DRUG OTHER PSS World Medical, Inc. SILVER NITRATE; POTASSIUM NITRATE 75; 25 mg/1; mg/1 E 20171231 68345-270_3ca4e1f1-1204-47e3-95b5-372683c5b71f 68345-270 HUMAN OTC DRUG REPARA Zinc Oxide DRESSING TOPICAL 20100517 OTC MONOGRAPH FINAL part347 PSS World Medical, Inc. ZINC OXIDE 25 g/1 E 20171231 68345-272_1d1142e3-db77-407f-bb28-7c9ecf46f801 68345-272 HUMAN OTC DRUG REPARA Zinc Oxide, Calamine DRESSING TOPICAL 20100517 OTC MONOGRAPH FINAL part347 PSS World Medical, Inc. ZINC OXIDE; FERRIC OXIDE RED; ZINC OXIDE 25; .0195; 1.2805 g/1; g/1; g/1 E 20171231 68345-620_167249b8-6ea3-4429-bb39-ce706cc5a5ae 68345-620 HUMAN OTC DRUG Antimicrobial Antiseptic Hand Wash CHLOROXYLENOL SOAP TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333 PSS World Medical, Inc. CHLOROXYLENOL .005 mL/mL E 20171231 68345-652_b840ef53-f095-4d3d-a4d3-e773d1a5573a 68345-652 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100421 OTC MONOGRAPH NOT FINAL part333 PSS World Medical, Inc. ALCOHOL .62 mL/mL E 20171231 68345-711_7c00d669-dee7-4d20-8ff3-7b25d39610db 68345-711 HUMAN OTC DRUG Antiseptic Hand Gel with Aloe ALCOHOL GEL TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part333 PSS World Medical, Inc. ALCOHOL 620 mg/g E 20171231 68345-720_28028226-a6ae-4ca1-9461-2bbd339133c9 68345-720 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part333A PSS World Medical, Inc. ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 68345-721_28028226-a6ae-4ca1-9461-2bbd339133c9 68345-721 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part333A PSS World Medical, Inc. ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 68345-814_3ac1ceb7-c80f-48fc-b6a5-a5029c37fb02 68345-814 HUMAN OTC DRUG Select Medical Products Triple Antibiotic BACITRACIN, NEOMYCIN and POLYMYXIN B OINTMENT TOPICAL 20071201 OTC MONOGRAPH FINAL part333B PSS WORLD MEDICAL, INC. BACITRACIN; NEOMYCIN; POLYMYXIN B 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 68345-817_e521695f-36e0-4d1c-a3a0-1347f5104ed6 68345-817 HUMAN OTC DRUG Antifungal Miconazole Nitrate CREAM TOPICAL 20120905 OTC MONOGRAPH FINAL part333C PSS World Medical, Inc. MICONAZOLE NITRATE 20 mg/g E 20171231 68345-818_1af9e8e1-3f2a-4b9b-93fd-e0588feec24d 68345-818 HUMAN OTC DRUG Repara Lanolin OINTMENT TOPICAL 20140806 OTC MONOGRAPH FINAL part347 PSS World Medical, Inc. LANOLIN 5 g/10g E 20171231 68345-820_9a511d5b-c719-4a2e-81fb-0cc6c55ad8a6 68345-820 HUMAN OTC DRUG Repara Triple Antibiotic BACITRACIN, NEOMYCIN and POLYMYXIN B OINTMENT TOPICAL 20071201 OTC MONOGRAPH FINAL part333B PSS WORLD MEDICAL, INC. BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 68345-850_7ff937a6-6d51-401c-b4a6-3340aa758a6f 68345-850 HUMAN OTC DRUG EVOKE Antiperspirant and Deodorant Roll-on ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20110615 OTC MONOGRAPH FINAL part350 PSS World Medical ALUMINUM CHLOROHYDRATE 78 mg/mL N 20181231 68345-862_615199fe-4ba3-5252-e053-2991aa0a47c3 68345-862 HUMAN OTC DRUG POVIDONE IODINE SWABSTICS ANTISEPTIC GERMICIDE POVIDONE-IODINE SWAB TOPICAL 20100512 20200401 OTC MONOGRAPH FINAL part333C PSS World Medical POVIDONE-IODINE 10 mg/mL N 20191231 68345-862_615199fe-4bb4-5252-e053-2991aa0a47c3 68345-862 HUMAN OTC DRUG POVIDONE IODINE SWABSTICS ANTISEPTIC GERMICIDE POVIDONE-IODINE SWAB TOPICAL 20100512 20200401 OTC MONOGRAPH FINAL part333C PSS World Medical POVIDONE-IODINE 10 mg/mL N 20191231 68345-863_ba566fab-596d-4c6d-a462-4fe8aa03b7c0 68345-863 HUMAN OTC DRUG Povidone Iodine Povidone-Iodine SWAB TOPICAL 20120905 OTC MONOGRAPH FINAL part333C PSS World Medical, Inc. POVIDONE-IODINE 100 mg/mL N 20181231 68345-864_61519133-9545-06aa-e053-2991aa0abc0c 68345-864 HUMAN OTC DRUG ISOPROPYL ALCOHOL ANTISEPTIC GERMICIDE ISOPROPYL ALCOHOL SWAB TOPICAL 20100503 20200401 OTC MONOGRAPH NOT FINAL part333A PSS World Medical ISOPROPYL ALCOHOL .7 1/1 N 20181231 68345-865_0124fdce-8659-41cb-bd51-b8a6a7acf56a 68345-865 HUMAN OTC DRUG Isopropyl Alcohol Swabsticks Isopropyl Alcohol SWAB TOPICAL 20130110 OTC MONOGRAPH FINAL part344 PSS World Medical, Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 68345-872_a30b96db-faf9-47ad-9d38-032beea44818 68345-872 HUMAN OTC DRUG Alcohol Prep Pads - Sterile ISOPROPYL ALCOHOL LIQUID TOPICAL 20100603 OTC MONOGRAPH FINAL part333 PSS World Medical ISOPROPYL ALCOHOL 70 g/100g N 20181231 68345-874_6510f43f-a345-46a6-a8f9-e372863de1a6 68345-874 HUMAN OTC DRUG Alcohol Prep Pads - Non Sterile ISOPROPYL ALCOHOL LIQUID TOPICAL 20100603 OTC MONOGRAPH FINAL part333 PSS World Medical ISOPROPYL ALCOHOL 70 g/100g N 20181231 68345-876_956c31c4-fad3-4121-9f0a-d3d0d3fd9d80 68345-876 HUMAN OTC DRUG Alcohol Prep Pads Lightweight Non-Sterile ISOPROPYL ALCOHOL LIQUID TOPICAL 20100903 OTC MONOGRAPH FINAL part333A PSS World Medical ISOPROPYL ALCOHOL 70 g/100g N 20181231 68345-878_810e1def-c235-451e-b380-6526828399f0 68345-878 HUMAN OTC DRUG Alcohol Prep Pads Isopropyl Alcohol CLOTH TOPICAL 20150527 OTC MONOGRAPH NOT FINAL part333A PSS World Medical, Inc. ISOPROPYL ALCOHOL 70 mg/1 N 20181231 68345-881_1833d872-a7ff-42e0-9923-7aa7730b1d32 68345-881 HUMAN OTC DRUG Obstetrical Antiseptic Towelette BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130619 OTC MONOGRAPH NOT FINAL part333E PSS World Medical, Inc. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 68345-883_dd2a5290-ea6d-4c5b-9242-0d2a4bad07f0 68345-883 HUMAN OTC DRUG Benzalkonium Chloride Towelette BENZALKONIUM CHLORIDE LIQUID TOPICAL 20130620 OTC MONOGRAPH NOT FINAL part333E PSS World Medical, Inc. BENZALKONIUM CHLORIDE .13 g/100g N 20191231 68345-908_fb5a8090-ca3a-4a0d-859b-8add23231e07 68345-908 HUMAN OTC DRUG Regimen Ethyl Alcohol GEL TOPICAL 20111102 OTC MONOGRAPH NOT FINAL part333A PSS World Medical, Inc. ALCOHOL 62 mL/100mL E 20171231 68345-965_df06608b-92b9-4aaf-8b14-70b969abd68c 68345-965 HUMAN OTC DRUG ETHYL ALCOHOL ALCOHOL GEL TOPICAL 20100421 OTC MONOGRAPH NOT FINAL part333 PSS World Medical, Inc. ALCOHOL .62 mL/mL E 20171231 68354-131_5f8ea1f0-55f3-706b-e053-2991aa0a4648 68354-131 HUMAN OTC DRUG ARTREX Camphor, Menthol, and Turpentine CREAM TOPICAL 20040401 OTC MONOGRAPH NOT FINAL part348 Bioved Pharmaceuticals CAMPHOR (NATURAL); MENTHOL; TURPENTINE 3; 1.8; 6 g/60g; g/60g; g/60g N 20181231 68356-103_410758df-fe8d-4a80-aafb-b6db68018397 68356-103 HUMAN OTC DRUG ISOPROPYL ALCOHOL PREP PAD ISOPROPYL ALCOHOL SWAB TOPICAL 20150110 OTC MONOGRAPH NOT FINAL part333A LernaPharm Loris Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 68356-104_e7198a5a-2f37-4f02-80b5-3ba5c6bf9bc3 68356-104 HUMAN OTC DRUG ISOPROPYL ALCOHOL PREP PAD STERILE ISOPROPYL ALCOHOL SWAB TOPICAL 20150110 OTC MONOGRAPH NOT FINAL part333A LernaPharm Loris Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 68356-109_02d78902-fd10-499f-a609-9243152be47b 68356-109 HUMAN OTC DRUG POVIDONE-IODINE POVIDONE-IODINE SWAB TOPICAL 20100104 OTC MONOGRAPH FINAL part333 LernaPharm Loris Inc. POVIDONE-IODINE .05 g/1 N 20181231 68356-117_a4ac11de-a7ab-40f6-9086-fb435649c6a3 68356-117 HUMAN OTC DRUG ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL SWAB TOPICAL 20100104 OTC MONOGRAPH NOT FINAL part333A LernaPharm Loris Inc. ISOPROPYL ALCOHOL .238 mL/1 N 20181231 68356-119_fe544c78-3b3c-4854-9816-97049f284c7f 68356-119 HUMAN OTC DRUG Loris Povidone-Iodine Solution Povidone-Iodine LIQUID TOPICAL 20130416 OTC MONOGRAPH NOT FINAL part333E LernaPharm Loris Inc. POVIDONE-IODINE 1 g/100mL N 20181231 68356-120_d54da4fb-66cd-4bb8-a1a8-07b829973471 68356-120 HUMAN OTC DRUG Loris 10% Povidone-Iodine and 70% Isopropyl Alcohol Solution Povidone-Iodine and Isopropyl Alcohol LIQUID TOPICAL 20160110 OTC MONOGRAPH NOT FINAL part333E LernaPharm Loris Inc. POVIDONE-IODINE; ISOPROPYL ALCOHOL 100; .7 g/mL; mL/mL N 20181231 68356-121_2d0c86e2-cc4a-4b1a-876e-a16f681bc3c7 68356-121 HUMAN OTC DRUG Loris 7.5% Povidone-Iodine and 74% Isopropyl Alcohol Solution Povidone-Iodine and Isopropyl Alcohol LIQUID TOPICAL 20160111 OTC MONOGRAPH NOT FINAL part333E LernaPharm Loris Inc. POVIDONE-IODINE; ISOPROPYL ALCOHOL 75; .74 g/mL; mL/mL N 20181231 68356-126_a1e1da36-6677-47cb-a03d-514f748f4c07 68356-126 HUMAN OTC DRUG Loris BZK Antiseptic Wipes Benzalkonium Chloride SWAB TOPICAL 20121121 OTC MONOGRAPH NOT FINAL part333A LernaPharm Loris Inc. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 68368-151_5ff5af3e-af90-8e26-e053-2991aa0ac128 68368-151 HUMAN OTC DRUG White Glo Professional Choice SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141203 OTC MONOGRAPH FINAL part355 Barros Laboratories Pty Limited SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 68368-152_5ff5af3e-af9d-8e26-e053-2991aa0ac128 68368-152 HUMAN OTC DRUG White Glo Smokers Formula SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141203 OTC MONOGRAPH FINAL part355 Barros Laboratories Pty Limited SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 68368-153_5ff5af3e-afaa-8e26-e053-2991aa0ac128 68368-153 HUMAN OTC DRUG White Glo Coffee Tea Drinkers Formula SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141203 OTC MONOGRAPH FINAL part355 Barros Laboratories Pty Limited SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 68368-154_5ff5af3e-afb7-8e26-e053-2991aa0ac128 68368-154 HUMAN OTC DRUG White Glo 2 in 1 with Mouthwash SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141203 OTC MONOGRAPH FINAL part355 Barros Laboratories Pty Limited SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 68368-155_5ff44afa-34fa-05b2-e053-2991aa0a2e5f 68368-155 HUMAN OTC DRUG White Glo 2in1 with Mouthwash SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20180101 OTC MONOGRAPH FINAL part355 Barros Laboratories Pty Limited SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 68368-156_635f8720-a886-4ec3-e053-2a91aa0afbe2 68368-156 HUMAN OTC DRUG White Glo Charcoal Deep Stain Remover Tooth SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20180201 OTC MONOGRAPH FINAL part355 Barros Laboratories Pty Limited SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20191231 68382-001_b0ff5c83-09ae-41bf-8549-e3952e010d23 68382-001 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Zydus Pharmaceuticals (USA) Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68382-003_deb24997-e889-469c-af20-27b45189291e 68382-003 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20070711 ANDA ANDA077621 Zydus Pharmaceuticals (USA) Inc. AZATHIOPRINE 50 1/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 68382-004_60a0711f-5f8f-403a-aa44-5433a5f4c079 68382-004 HUMAN PRESCRIPTION DRUG topiramate topiramate CAPSULE, COATED PELLETS ORAL 20091014 ANDA ANDA078877 Zydus Pharmaceuticals (USA) Inc. TOPIRAMATE 15 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68382-005_60a0711f-5f8f-403a-aa44-5433a5f4c079 68382-005 HUMAN PRESCRIPTION DRUG topiramate topiramate CAPSULE, COATED PELLETS ORAL 20091014 ANDA ANDA078877 Zydus Pharmaceuticals (USA) Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68382-006_3cb42e1f-89d0-4718-8c04-3933b78f66bb 68382-006 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-007_3cb42e1f-89d0-4718-8c04-3933b78f66bb 68382-007 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-008_3cb42e1f-89d0-4718-8c04-3933b78f66bb 68382-008 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-009_3cb42e1f-89d0-4718-8c04-3933b78f66bb 68382-009 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-010_3cb42e1f-89d0-4718-8c04-3933b78f66bb 68382-010 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-011_3cb42e1f-89d0-4718-8c04-3933b78f66bb 68382-011 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20090127 ANDA ANDA077633 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-012_324e5b4e-9642-4ba3-947a-3e93b5cbdfb6 68382-012 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20080919 ANDA ANDA078620 Zydus Pharmaceuticals (USA) Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68382-013_324e5b4e-9642-4ba3-947a-3e93b5cbdfb6 68382-013 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20080919 ANDA ANDA078620 Zydus Pharmaceuticals (USA) Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68382-014_324e5b4e-9642-4ba3-947a-3e93b5cbdfb6 68382-014 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20080919 ANDA ANDA078620 Zydus Pharmaceuticals (USA) Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68382-015_428d0aab-fb4e-48ae-84ce-800244178da7 68382-015 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Zydus Pharmaceuticals (USA) Inc. LEVOFLOXACIN 250 mg/1 N 20181231 68382-016_428d0aab-fb4e-48ae-84ce-800244178da7 68382-016 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Zydus Pharmaceuticals (USA) Inc. LEVOFLOXACIN 500 mg/1 N 20181231 68382-017_428d0aab-fb4e-48ae-84ce-800244178da7 68382-017 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Zydus Pharmaceuticals (USA) Inc. LEVOFLOXACIN 750 mg/1 N 20181231 68382-018_a06ccfa7-40eb-49e0-bcc4-6be55f03ee92 68382-018 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68382-019_a06ccfa7-40eb-49e0-bcc4-6be55f03ee92 68382-019 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68382-020_a06ccfa7-40eb-49e0-bcc4-6be55f03ee92 68382-020 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 50 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68382-021_a06ccfa7-40eb-49e0-bcc4-6be55f03ee92 68382-021 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68382-022_a8a55b1a-b576-4fad-853a-204d877bf0c0 68382-022 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Zydus Pharmaceuticals (USA) Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-023_a8a55b1a-b576-4fad-853a-204d877bf0c0 68382-023 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Zydus Pharmaceuticals (USA) Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-024_a8a55b1a-b576-4fad-853a-204d877bf0c0 68382-024 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Zydus Pharmaceuticals (USA) Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-027_50ab0e8f-2d25-477d-875a-652fefd827ab 68382-027 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20050928 ANDA ANDA077060 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-028_24abc718-802b-4916-992e-88d0baabc877 68382-028 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100320 ANDA ANDA077064 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-028_50ab0e8f-2d25-477d-875a-652fefd827ab 68382-028 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-029_24abc718-802b-4916-992e-88d0baabc877 68382-029 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100320 ANDA ANDA077064 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-029_50ab0e8f-2d25-477d-875a-652fefd827ab 68382-029 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-030_24abc718-802b-4916-992e-88d0baabc877 68382-030 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20100320 ANDA ANDA077064 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-030_50ab0e8f-2d25-477d-875a-652fefd827ab 68382-030 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20050928 ANDA ANDA077064 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-031_9d40cb55-2188-4dcb-8d3d-058550e4dc1f 68382-031 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 Zydus Pharmaceuticals (USA) Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-032_9d40cb55-2188-4dcb-8d3d-058550e4dc1f 68382-032 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 Zydus Pharmaceuticals (USA) Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-033_9d40cb55-2188-4dcb-8d3d-058550e4dc1f 68382-033 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20100306 ANDA ANDA077100 Zydus Pharmaceuticals (USA) Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-034_c3b60f1b-b752-4667-aa77-ef6c2e54abeb 68382-034 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68382-035_c3b60f1b-b752-4667-aa77-ef6c2e54abeb 68382-035 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68382-036_c3b60f1b-b752-4667-aa77-ef6c2e54abeb 68382-036 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68382-039_50ab0e8f-2d25-477d-875a-652fefd827ab 68382-039 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20050928 ANDA ANDA077078 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-040_314f9343-9b16-4321-8b1a-d3cbd229d442 68382-040 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Zydus Pharmaceuticals (USA) Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68382-041_314f9343-9b16-4321-8b1a-d3cbd229d442 68382-041 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Zydus Pharmaceuticals (USA) Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68382-042_314f9343-9b16-4321-8b1a-d3cbd229d442 68382-042 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20051214 ANDA ANDA040596 Zydus Pharmaceuticals (USA) Inc. PROMETHAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68382-043_d10b1bfa-e16f-4d5f-a184-d2935e786de1 68382-043 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20171202 ANDA ANDA077106 Zydus Pharmaceuticals (USA) Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68382-044_d10b1bfa-e16f-4d5f-a184-d2935e786de1 68382-044 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20171202 ANDA ANDA077106 Zydus Pharmaceuticals (USA) Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68382-045_d10b1bfa-e16f-4d5f-a184-d2935e786de1 68382-045 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20171202 ANDA ANDA077106 Zydus Pharmaceuticals (USA) Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68382-046_a30ea3a7-8c57-47ac-97ad-5f71ca8ea2a8 68382-046 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Zydus Pharmaceuticals (USA) Inc. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 68382-050_352d9ba4-fadf-46f4-95e1-f9c19090c1f9 68382-050 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 Zydus Pharmaceuticals (USA) Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68382-051_352d9ba4-fadf-46f4-95e1-f9c19090c1f9 68382-051 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20060719 ANDA ANDA077921 Zydus Pharmaceuticals (USA) Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68382-052_85e44782-3963-4297-ac40-5362715e39ba 68382-052 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 68382-053_85e44782-3963-4297-ac40-5362715e39ba 68382-053 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 68382-054_85e44782-3963-4297-ac40-5362715e39ba 68382-054 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 68382-055_85e44782-3963-4297-ac40-5362715e39ba 68382-055 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 68382-056_85e44782-3963-4297-ac40-5362715e39ba 68382-056 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 68382-057_85e44782-3963-4297-ac40-5362715e39ba 68382-057 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 68382-058_85e44782-3963-4297-ac40-5362715e39ba 68382-058 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 68382-059_85e44782-3963-4297-ac40-5362715e39ba 68382-059 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 68382-064_85e44782-3963-4297-ac40-5362715e39ba 68382-064 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20060619 ANDA ANDA040663 Zydus Pharmaceuticals (USA) Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 68382-065_e1b05c5e-be9a-40e3-b042-a2da5be86d99 68382-065 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Zydus Pharmaceuticals (USA) Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68382-066_e1b05c5e-be9a-40e3-b042-a2da5be86d99 68382-066 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Zydus Pharmaceuticals (USA) Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68382-067_e1b05c5e-be9a-40e3-b042-a2da5be86d99 68382-067 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Zydus Pharmaceuticals (USA) Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68382-068_e1b05c5e-be9a-40e3-b042-a2da5be86d99 68382-068 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Zydus Pharmaceuticals (USA) Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68382-069_e1b05c5e-be9a-40e3-b042-a2da5be86d99 68382-069 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077837 Zydus Pharmaceuticals (USA) Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68382-070_a5ebbae9-4158-44be-8fbf-b8dce92de3bc 68382-070 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Zydus Pharmaceuticals (USA) Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68382-071_a5ebbae9-4158-44be-8fbf-b8dce92de3bc 68382-071 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Zydus Pharmaceuticals (USA) Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68382-072_a5ebbae9-4158-44be-8fbf-b8dce92de3bc 68382-072 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Zydus Pharmaceuticals (USA) Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68382-073_a5ebbae9-4158-44be-8fbf-b8dce92de3bc 68382-073 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20100330 ANDA ANDA077751 Zydus Pharmaceuticals (USA) Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68382-074_f31b6808-1da5-490a-a5c8-5f87f41971f4 68382-074 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20171205 ANDA ANDA078900 Zydus Pharmaceuticals (USA) Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68382-077_c10d9480-70c5-a61c-b4fc-4bdbe405cb2a 68382-077 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20081215 NDA AUTHORIZED GENERIC NDA022224 Zydus Pharmaceuticals USA Inc FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68382-078_c10d9480-70c5-a61c-b4fc-4bdbe405cb2a 68382-078 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20081215 NDA AUTHORIZED GENERIC NDA022224 Zydus Pharmaceuticals USA Inc FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68382-079_c9cf611d-3458-4e48-af2a-a5d9aa4fe990 68382-079 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 Zydus Pharmaceuticals (USA) Inc. HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] N 20181231 68382-080_c9cf611d-3458-4e48-af2a-a5d9aa4fe990 68382-080 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 Zydus Pharmaceuticals (USA) Inc. HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] N 20181231 68382-081_c9cf611d-3458-4e48-af2a-a5d9aa4fe990 68382-081 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20080103 ANDA ANDA077580 Zydus Pharmaceuticals (USA) Inc. HALOPERIDOL 20 mg/1 Typical Antipsychotic [EPC] N 20181231 68382-092_bdddd1a5-a1f3-44fb-ae09-ae0a604cce43 68382-092 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Zydus Pharmaceuticals (USA) Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68382-093_bdddd1a5-a1f3-44fb-ae09-ae0a604cce43 68382-093 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Zydus Pharmaceuticals (USA) Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68382-094_bdddd1a5-a1f3-44fb-ae09-ae0a604cce43 68382-094 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Zydus Pharmaceuticals (USA) Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68382-095_bdddd1a5-a1f3-44fb-ae09-ae0a604cce43 68382-095 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Zydus Pharmaceuticals (USA) Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68382-096_1af646d4-dcd5-4357-a150-402a985c4bd3 68382-096 HUMAN PRESCRIPTION DRUG Hydroxychloroquine sulfate Hydroxychloroquine sulfate TABLET, FILM COATED ORAL 20080103 ANDA ANDA040657 Zydus Pharmaceuticals (USA) Inc. HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] N 20181231 68382-097_b0ff5c83-09ae-41bf-8549-e3952e010d23 68382-097 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Zydus Pharmaceuticals (USA) Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68382-098_b0ff5c83-09ae-41bf-8549-e3952e010d23 68382-098 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Zydus Pharmaceuticals (USA) Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68382-099_b0ff5c83-09ae-41bf-8549-e3952e010d23 68382-099 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Zydus Pharmaceuticals (USA) Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68382-101_a06ccfa7-40eb-49e0-bcc4-6be55f03ee92 68382-101 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20080613 ANDA ANDA077653 Zydus Pharmaceuticals (USA) Inc. VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68382-102_8a1adfe5-4fdc-47fb-a7ba-363c40e96b26 68382-102 HUMAN PRESCRIPTION DRUG escitalopram escitalopram TABLET, FILM COATED ORAL 20171207 ANDA ANDA077734 Zydus Pharmaceuticals (USA) Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68382-103_8a1adfe5-4fdc-47fb-a7ba-363c40e96b26 68382-103 HUMAN PRESCRIPTION DRUG escitalopram escitalopram TABLET, FILM COATED ORAL 20171207 ANDA ANDA077734 Zydus Pharmaceuticals (USA) Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68382-104_8a1adfe5-4fdc-47fb-a7ba-363c40e96b26 68382-104 HUMAN PRESCRIPTION DRUG escitalopram escitalopram TABLET, FILM COATED ORAL 20171207 ANDA ANDA077734 Zydus Pharmaceuticals (USA) Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68382-106_d7ed6d6c-1909-4d94-9b85-64c094e37b67 68382-106 HUMAN PRESCRIPTION DRUG divalproex sodium divalproex sodium CAPSULE, COATED PELLETS ORAL 20090127 ANDA ANDA078919 Zydus Pharmaceuticals (USA) Inc. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-108_3cb42e1f-89d0-4718-8c04-3933b78f66bb 68382-108 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090123 ANDA ANDA078009 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-109_3cb42e1f-89d0-4718-8c04-3933b78f66bb 68382-109 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090123 ANDA ANDA078009 Zydus Pharmaceuticals (USA) Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-110_05da95a8-cdbc-4ccf-801e-17358ca63cb0 68382-110 HUMAN PRESCRIPTION DRUG Bromocriptine mesylate Bromocriptine mesylate CAPSULE ORAL 20090123 ANDA ANDA078899 Zydus Pharmaceuticals (USA) Inc. BROMOCRIPTINE MESYLATE 5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 68382-112_1441a0a5-7a21-4d35-a184-db39117ca5e3 68382-112 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-113_1441a0a5-7a21-4d35-a184-db39117ca5e3 68382-113 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-114_1441a0a5-7a21-4d35-a184-db39117ca5e3 68382-114 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-115_1441a0a5-7a21-4d35-a184-db39117ca5e3 68382-115 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-116_1441a0a5-7a21-4d35-a184-db39117ca5e3 68382-116 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-117_1441a0a5-7a21-4d35-a184-db39117ca5e3 68382-117 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20081113 ANDA ANDA078040 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-118_df47ff8b-81a6-4a2c-aac5-ac089a736ecb 68382-118 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20171202 ANDA ANDA077621 Zydus Pharmaceuticals (USA) Inc. AZATHIOPRINE 25 1/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 68382-119_df47ff8b-81a6-4a2c-aac5-ac089a736ecb 68382-119 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20171202 ANDA ANDA077621 Zydus Pharmaceuticals (USA) Inc. AZATHIOPRINE 75 1/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 68382-120_df47ff8b-81a6-4a2c-aac5-ac089a736ecb 68382-120 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20171202 ANDA ANDA077621 Zydus Pharmaceuticals (USA) Inc. AZATHIOPRINE 100 1/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 68382-121_e0e90ef7-a6ab-4cc6-bdf7-a2872e5c3bc6 68382-121 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Zydus Pharmaceuticals (USA) Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68382-122_e0e90ef7-a6ab-4cc6-bdf7-a2872e5c3bc6 68382-122 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Zydus Pharmaceuticals (USA) Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68382-123_e0e90ef7-a6ab-4cc6-bdf7-a2872e5c3bc6 68382-123 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Zydus Pharmaceuticals (USA) Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68382-125_c533d735-f4c5-4c7d-8fa4-64ede71ec261 68382-125 HUMAN PRESCRIPTION DRUG acyclovir ACYCLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170817 ANDA ANDA206606 Zydus Pharmaceuticals (USA) Inc. ACYCLOVIR SODIUM 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68382-126_c533d735-f4c5-4c7d-8fa4-64ede71ec261 68382-126 HUMAN PRESCRIPTION DRUG acyclovir ACYCLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170817 ANDA ANDA206606 Zydus Pharmaceuticals (USA) Inc. ACYCLOVIR SODIUM 1000 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68382-127_a30ea3a7-8c57-47ac-97ad-5f71ca8ea2a8 68382-127 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Zydus Pharmaceuticals (USA) Inc. RIBAVIRIN 400 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 68382-128_a30ea3a7-8c57-47ac-97ad-5f71ca8ea2a8 68382-128 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Zydus Pharmaceuticals (USA) Inc. RIBAVIRIN 500 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 68382-129_a30ea3a7-8c57-47ac-97ad-5f71ca8ea2a8 68382-129 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin TABLET, FILM COATED ORAL 20051205 ANDA ANDA077094 Zydus Pharmaceuticals (USA) Inc. RIBAVIRIN 600 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 68382-130_f67f2a1b-167a-49c7-bbb1-8f6d5c5b3cdc 68382-130 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20090504 ANDA ANDA065433 Zydus Pharmaceuticals (USA) Inc. MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] E 20171231 68382-131_f67f2a1b-167a-49c7-bbb1-8f6d5c5b3cdc 68382-131 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil TABLET, FILM COATED ORAL 20090504 ANDA ANDA065477 Zydus Pharmaceuticals (USA) Inc. MYCOPHENOLATE MOFETIL 500 mg/1 Antimetabolite Immunosuppressant [EPC] E 20171231 68382-132_bcb383f3-196a-4332-9904-08dd8b5da9bd 68382-132 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100427 ANDA ANDA078225 Zydus Pharmaceuticals (USA) Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68382-133_a617e5ba-ba8d-4bd8-b08f-fdc5a9191b0b 68382-133 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130107 ANDA ANDA078239 Zydus Pharmaceuticals (USA) Inc. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-134_a617e5ba-ba8d-4bd8-b08f-fdc5a9191b0b 68382-134 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130107 ANDA ANDA078239 Zydus Pharmaceuticals (USA) Inc. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-135_c516a5a7-cfc8-4b3b-a8bc-7644c3313673 68382-135 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Zydus Pharmaceuticals (USA) Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-136_c516a5a7-cfc8-4b3b-a8bc-7644c3313673 68382-136 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Zydus Pharmaceuticals (USA) Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-137_c516a5a7-cfc8-4b3b-a8bc-7644c3313673 68382-137 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Zydus Pharmaceuticals (USA) Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-138_16e9304c-a029-4d23-ae3f-e197def9a302 68382-138 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Zydus Pharmaceuticals (USA) Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68382-139_16e9304c-a029-4d23-ae3f-e197def9a302 68382-139 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Zydus Pharmaceuticals (USA) Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68382-140_16e9304c-a029-4d23-ae3f-e197def9a302 68382-140 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Zydus Pharmaceuticals (USA) Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68382-141_16e9304c-a029-4d23-ae3f-e197def9a302 68382-141 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA078235 Zydus Pharmaceuticals (USA) Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68382-142_39beef3c-07d6-4fc9-a571-05cddd4b0da2 68382-142 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078385 Zydus Pharmaceuticals (USA) Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-143_39beef3c-07d6-4fc9-a571-05cddd4b0da2 68382-143 HUMAN PRESCRIPTION DRUG LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED ORAL 20101004 ANDA ANDA078385 Zydus Pharmaceuticals (USA) Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-144_06649739-aa4d-41b3-9035-043c1f705771 68382-144 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Zydus Pharmaceuticals (USA) Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68382-145_06649739-aa4d-41b3-9035-043c1f705771 68382-145 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Zydus Pharmaceuticals (USA) Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68382-146_06649739-aa4d-41b3-9035-043c1f705771 68382-146 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Zydus Pharmaceuticals (USA) Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68382-147_06649739-aa4d-41b3-9035-043c1f705771 68382-147 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20101120 ANDA ANDA078832 Zydus Pharmaceuticals (USA) Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68382-154_97992bce-e8b8-466f-83bd-bace64de39fc 68382-154 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100629 ANDA ANDA078516 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-155_97992bce-e8b8-466f-83bd-bace64de39fc 68382-155 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100629 ANDA ANDA078516 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-156_97992bce-e8b8-466f-83bd-bace64de39fc 68382-156 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, ORALLY DISINTEGRATING ORAL 20100629 ANDA ANDA078516 Zydus Pharmaceuticals (USA) Inc. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-161_4dd0a923-1766-4255-9d36-58a65a12cb43 68382-161 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Zydus Pharmaceuticals (USA) Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-162_4dd0a923-1766-4255-9d36-58a65a12cb43 68382-162 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Zydus Pharmaceuticals (USA) Inc. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-163_4dd0a923-1766-4255-9d36-58a65a12cb43 68382-163 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Zydus Pharmaceuticals (USA) Inc. PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-164_4dd0a923-1766-4255-9d36-58a65a12cb43 68382-164 HUMAN PRESCRIPTION DRUG PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20140415 ANDA ANDA090321 Zydus Pharmaceuticals (USA) Inc. PROPRANOLOL HYDROCHLORIDE 160 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-165_f42bc630-5fe4-4947-ada0-a5ca55e4f7ed 68382-165 HUMAN PRESCRIPTION DRUG levetiracetam levetiracetam TABLET, FILM COATED ORAL 20171205 ANDA ANDA078918 Zydus Pharmaceuticals (USA) Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68382-168_f42bc630-5fe4-4947-ada0-a5ca55e4f7ed 68382-168 HUMAN PRESCRIPTION DRUG levetiracetam levetiracetam TABLET, FILM COATED ORAL 20171205 ANDA ANDA078918 Zydus Pharmaceuticals (USA) Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68382-169_c411a0ec-2626-4aed-b34e-e6c90c235174 68382-169 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride Benazepril hydrochloride TABLET, FILM COATED ORAL 20171113 ANDA ANDA078848 Zydus Pharmaceuticals (USA) Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68382-170_c411a0ec-2626-4aed-b34e-e6c90c235174 68382-170 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride Benazepril hydrochloride TABLET, FILM COATED ORAL 20171113 ANDA ANDA078848 Zydus Pharmaceuticals (USA) Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68382-171_c411a0ec-2626-4aed-b34e-e6c90c235174 68382-171 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride Benazepril hydrochloride TABLET, FILM COATED ORAL 20171113 ANDA ANDA078848 Zydus Pharmaceuticals (USA) Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68382-172_c411a0ec-2626-4aed-b34e-e6c90c235174 68382-172 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride Benazepril hydrochloride TABLET, FILM COATED ORAL 20171113 ANDA ANDA078848 Zydus Pharmaceuticals (USA) Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68382-177_992cc7c5-4750-46be-8b7f-d820000c8deb 68382-177 HUMAN PRESCRIPTION DRUG galantamine galantamine TABLET, FILM COATED ORAL 20111010 ANDA ANDA078898 Zydus Pharmaceuticals (USA) Inc. GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68382-178_992cc7c5-4750-46be-8b7f-d820000c8deb 68382-178 HUMAN PRESCRIPTION DRUG galantamine galantamine TABLET, FILM COATED ORAL 20111010 ANDA ANDA078898 Zydus Pharmaceuticals (USA) Inc. GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68382-179_992cc7c5-4750-46be-8b7f-d820000c8deb 68382-179 HUMAN PRESCRIPTION DRUG galantamine galantamine TABLET, FILM COATED ORAL 20111010 ANDA ANDA078898 Zydus Pharmaceuticals (USA) Inc. GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68382-180_056ab322-8a28-4a55-807e-f6df89d9a156 68382-180 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Zydus Pharmaceuticals (USA) Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 68382-181_056ab322-8a28-4a55-807e-f6df89d9a156 68382-181 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Zydus Pharmaceuticals (USA) Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 68382-182_056ab322-8a28-4a55-807e-f6df89d9a156 68382-182 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Zydus Pharmaceuticals (USA) Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 68382-183_056ab322-8a28-4a55-807e-f6df89d9a156 68382-183 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Zydus Pharmaceuticals (USA) Inc. BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 68382-184_6f28115f-1ae6-4d4b-9266-581a0d7097ae 68382-184 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20160505 ANDA ANDA078905 Zydus Pharmaceuticals (USA) Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-185_6f28115f-1ae6-4d4b-9266-581a0d7097ae 68382-185 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20160505 ANDA ANDA078905 Zydus Pharmaceuticals (USA) Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-186_6f28115f-1ae6-4d4b-9266-581a0d7097ae 68382-186 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20160505 ANDA ANDA078905 Zydus Pharmaceuticals (USA) Inc. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-187_2854052e-996b-4bdf-9f4d-f6286df82b71 68382-187 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080522 ANDA ANDA040874 Zydus Pharmaceuticals (USA) Inc. DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 68382-188_2854052e-996b-4bdf-9f4d-f6286df82b71 68382-188 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080522 ANDA ANDA040874 Zydus Pharmaceuticals (USA) Inc. DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 68382-189_2854052e-996b-4bdf-9f4d-f6286df82b71 68382-189 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20080522 ANDA ANDA040874 Zydus Pharmaceuticals (USA) Inc. DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 68382-196_5d822a2a-f196-47c4-ac01-9a6a125906a4 68382-196 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100710 ANDA ANDA078920 Zydus Pharmaceuticals (USA) Inc. PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68382-197_5d822a2a-f196-47c4-ac01-9a6a125906a4 68382-197 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100710 ANDA ANDA078920 Zydus Pharmaceuticals (USA) Inc. PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68382-198_5d822a2a-f196-47c4-ac01-9a6a125906a4 68382-198 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100710 ANDA ANDA078920 Zydus Pharmaceuticals (USA) Inc. PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68382-199_5d822a2a-f196-47c4-ac01-9a6a125906a4 68382-199 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100710 ANDA ANDA078920 Zydus Pharmaceuticals (USA) Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68382-200_5d822a2a-f196-47c4-ac01-9a6a125906a4 68382-200 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20100710 ANDA ANDA078920 Zydus Pharmaceuticals (USA) Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68382-201_78b319d5-2b3b-ffa6-2db4-c6d64f22ea3c 68382-201 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140630 NDA NDA020381 Zydus Pharmaceuticals USA Inc NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 68382-202_78b319d5-2b3b-ffa6-2db4-c6d64f22ea3c 68382-202 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140630 NDA NDA020381 Zydus Pharmaceuticals USA Inc NIACIN 750 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 68382-203_78b319d5-2b3b-ffa6-2db4-c6d64f22ea3c 68382-203 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140630 NDA NDA020381 Zydus Pharmaceuticals USA Inc NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 68382-204_29eb856a-a36a-4dd9-858b-66cf8dd2a157 68382-204 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20121016 ANDA ANDA078926 Zydus Pharmaceuticals (USA) Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68382-205_29eb856a-a36a-4dd9-858b-66cf8dd2a157 68382-205 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20121016 ANDA ANDA078926 Zydus Pharmaceuticals (USA) Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68382-209_726df346-2d67-4ca2-b424-c1add188d241 68382-209 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, COATED ORAL 20100627 ANDA ANDA078921 Zydus Pharmaceuticals (USA) Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 68382-212_52216648-f369-4e3d-971a-e57f8805454a 68382-212 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20171122 ANDA ANDA077625 Zydus Pharmaceuticals (USA) Inc. ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68382-213_52216648-f369-4e3d-971a-e57f8805454a 68382-213 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20171122 ANDA ANDA077625 Zydus Pharmaceuticals (USA) Inc. ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68382-214_52216648-f369-4e3d-971a-e57f8805454a 68382-214 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20171122 ANDA ANDA077625 Zydus Pharmaceuticals (USA) Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68382-216_ea62df65-990f-495d-a1f8-cb975ab719ee 68382-216 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20171206 ANDA ANDA079017 Zydus Pharmaceuticals (USA) Inc. ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68382-217_ea62df65-990f-495d-a1f8-cb975ab719ee 68382-217 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20171206 ANDA ANDA079017 Zydus Pharmaceuticals (USA) Inc. ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68382-218_ea62df65-990f-495d-a1f8-cb975ab719ee 68382-218 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20171206 ANDA ANDA079017 Zydus Pharmaceuticals (USA) Inc. ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68382-219_ea62df65-990f-495d-a1f8-cb975ab719ee 68382-219 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20171206 ANDA ANDA079017 Zydus Pharmaceuticals (USA) Inc. ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68382-220_ea62df65-990f-495d-a1f8-cb975ab719ee 68382-220 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20171206 ANDA ANDA079017 Zydus Pharmaceuticals (USA) Inc. ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68382-223_ea62df65-990f-495d-a1f8-cb975ab719ee 68382-223 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20171206 ANDA ANDA079017 Zydus Pharmaceuticals (USA) Inc. ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68382-224_b56b10fc-39bf-4175-9f16-9ad93c1c38bd 68382-224 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20090706 ANDA ANDA079089 Zydus Pharmaceuticals (USA) Inc. BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 68382-227_5dfb1215-9cd2-479f-8531-d69d7d4d05fc 68382-227 HUMAN PRESCRIPTION DRUG Amiodarone hydrochloride Amiodarone hydrochloride TABLET ORAL 20090810 ANDA ANDA079029 Zydus Pharmaceuticals (USA) Inc. AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 68382-228_eeadd830-cea2-e2ae-39f2-ea16c47b61a0 68382-228 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Zydus Pharmaceuticals USA Inc FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68382-230_eeadd830-cea2-e2ae-39f2-ea16c47b61a0 68382-230 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20041105 NDA AUTHORIZED GENERIC NDA021656 Zydus Pharmaceuticals USA Inc FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68382-232_c10d9480-70c5-a61c-b4fc-4bdbe405cb2a 68382-232 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20160912 NDA AUTHORIZED GENERIC NDA022224 Zydus Pharmaceuticals USA Inc FENOFIBRIC ACID 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68382-233_c10d9480-70c5-a61c-b4fc-4bdbe405cb2a 68382-233 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid CAPSULE, DELAYED RELEASE ORAL 20160912 NDA AUTHORIZED GENERIC NDA022224 Zydus Pharmaceuticals USA Inc FENOFIBRIC ACID 135 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68382-234_ea68e58a-60d6-49a1-aa4c-83b6fd95dec1 68382-234 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE, GELATIN COATED ORAL 20171117 ANDA ANDA065217 Zydus Pharmaceuticals (USA) Inc. CLINDAMYCIN HYDROCHLORIDE 75 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68382-235_ea68e58a-60d6-49a1-aa4c-83b6fd95dec1 68382-235 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE, GELATIN COATED ORAL 20171123 ANDA ANDA065217 Zydus Pharmaceuticals (USA) Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68382-236_ea68e58a-60d6-49a1-aa4c-83b6fd95dec1 68382-236 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE, GELATIN COATED ORAL 20171123 ANDA ANDA065217 Zydus Pharmaceuticals (USA) Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68382-237_06d48ea5-6397-41ee-8505-12b91efd6288 68382-237 HUMAN PRESCRIPTION DRUG Ziprasidone Ziprasidone CAPSULE ORAL 20171228 ANDA ANDA208988 Zydus Pharmaceuticals (USA) Inc. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-238_06d48ea5-6397-41ee-8505-12b91efd6288 68382-238 HUMAN PRESCRIPTION DRUG Ziprasidone Ziprasidone CAPSULE ORAL 20171228 ANDA ANDA208988 Zydus Pharmaceuticals (USA) Inc. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-239_06d48ea5-6397-41ee-8505-12b91efd6288 68382-239 HUMAN PRESCRIPTION DRUG Ziprasidone Ziprasidone CAPSULE ORAL 20171228 ANDA ANDA208988 Zydus Pharmaceuticals (USA) Inc. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-240_06d48ea5-6397-41ee-8505-12b91efd6288 68382-240 HUMAN PRESCRIPTION DRUG Ziprasidone Ziprasidone CAPSULE ORAL 20171228 ANDA ANDA208988 Zydus Pharmaceuticals (USA) Inc. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 68382-246_d502a350-4e23-4e4c-88fa-e67956dfc96c 68382-246 HUMAN PRESCRIPTION DRUG Ethacrynate Sodium Ethacrynate Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20180124 ANDA ANDA207758 Zydus Pharmaceuticals (USA) Inc. ETHACRYNATE SODIUM 50 mg/50mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68382-247_608a0e26-3579-4c7b-8c8f-f3b01f6ce542 68382-247 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070409 ANDA ANDA040597 Zydus Pharmaceuticals (USA) Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68382-248_608a0e26-3579-4c7b-8c8f-f3b01f6ce542 68382-248 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070409 ANDA ANDA040597 Zydus Pharmaceuticals (USA) Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68382-255_158daf37-d567-4739-be20-4df5dc6a0eb4 68382-255 HUMAN PRESCRIPTION DRUG oxybutynin oxybutynin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170810 ANDA ANDA202332 Zydus Pharmaceuticals (USA) Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68382-256_158daf37-d567-4739-be20-4df5dc6a0eb4 68382-256 HUMAN PRESCRIPTION DRUG oxybutynin oxybutynin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170810 ANDA ANDA202332 Zydus Pharmaceuticals (USA) Inc. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68382-257_158daf37-d567-4739-be20-4df5dc6a0eb4 68382-257 HUMAN PRESCRIPTION DRUG oxybutynin oxybutynin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170810 ANDA ANDA202332 Zydus Pharmaceuticals (USA) Inc. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68382-260_a7b2eb32-91ce-402d-98e1-4c352d18b08e 68382-260 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20060125 ANDA ANDA077224 Zydus Pharmaceuticals (USA) Inc. RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 68382-261_c3eeb0e1-234d-4b72-bebe-8e158dd4e1b1 68382-261 HUMAN PRESCRIPTION DRUG ACETAZOLAMIDE acetazolamide CAPSULE, EXTENDED RELEASE ORAL 20081215 ANDA ANDA040904 Zydus Pharmaceuticals USA Inc. ACETAZOLAMIDE 500 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 68382-266_551eeb91-8c53-2359-ae01-40d469f4ca93 68382-266 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20100614 NDA AUTHORIZED GENERIC NDA021606 Zydus Pharmaceuticals USA Inc PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20191231 68382-267_551eeb91-8c53-2359-ae01-40d469f4ca93 68382-267 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE, LIQUID FILLED ORAL 20100614 NDA AUTHORIZED GENERIC NDA021606 Zydus Pharmaceuticals USA Inc PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20191231 68382-269_eeadd830-cea2-e2ae-39f2-ea16c47b61a0 68382-269 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160209 NDA AUTHORIZED GENERIC NDA021656 Zydus Pharmaceuticals USA Inc FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68382-270_eeadd830-cea2-e2ae-39f2-ea16c47b61a0 68382-270 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160209 NDA AUTHORIZED GENERIC NDA021656 Zydus Pharmaceuticals USA Inc FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68382-271_e628f96d-7191-4338-8d08-d79345348da4 68382-271 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Zydus Pharmaceuticals (USA) Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68382-272_e628f96d-7191-4338-8d08-d79345348da4 68382-272 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Zydus Pharmaceuticals (USA) Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68382-273_e628f96d-7191-4338-8d08-d79345348da4 68382-273 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Zydus Pharmaceuticals (USA) Inc. ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68382-293_4d506b3b-9537-4d67-8364-a71e246dd0a2 68382-293 HUMAN PRESCRIPTION DRUG indomethacin indomethacin CAPSULE ORAL 20160721 ANDA ANDA090403 Zydus Pharmaceuticals (USA) Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68382-294_4d506b3b-9537-4d67-8364-a71e246dd0a2 68382-294 HUMAN PRESCRIPTION DRUG indomethacin indomethacin CAPSULE ORAL 20160721 ANDA ANDA090403 Zydus Pharmaceuticals (USA) Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68382-299_1cb04234-647d-47e0-ad5e-77c2fd6a3d5d 68382-299 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20171208 ANDA ANDA079213 Zydus Pharmaceuticals (USA) Inc. IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-300_1cb04234-647d-47e0-ad5e-77c2fd6a3d5d 68382-300 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20171208 ANDA ANDA079213 Zydus Pharmaceuticals (USA) Inc. IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-301_1cb04234-647d-47e0-ad5e-77c2fd6a3d5d 68382-301 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20171208 ANDA ANDA079213 Zydus Pharmaceuticals (USA) Inc. IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-302_14292556-4fa4-4383-87b7-34fad7b9b966 68382-302 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20110525 ANDA ANDA090100 Zydus Pharmaceuticals (USA) Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68382-303_14292556-4fa4-4383-87b7-34fad7b9b966 68382-303 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20110525 ANDA ANDA090100 Zydus Pharmaceuticals (USA) Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68382-306_d22097c8-98a9-40fa-b317-ecb5b6cddd99 68382-306 HUMAN PRESCRIPTION DRUG pioglitazone pioglitazone TABLET ORAL 20161116 ANDA ANDA202456 Zydus Pharmaceuticals (USA) Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 68382-307_d22097c8-98a9-40fa-b317-ecb5b6cddd99 68382-307 HUMAN PRESCRIPTION DRUG pioglitazone pioglitazone TABLET ORAL 20161116 ANDA ANDA202456 Zydus Pharmaceuticals (USA) Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 68382-308_d22097c8-98a9-40fa-b317-ecb5b6cddd99 68382-308 HUMAN PRESCRIPTION DRUG pioglitazone pioglitazone TABLET ORAL 20161116 ANDA ANDA202456 Zydus Pharmaceuticals (USA) Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 68382-309_53dbb9b9-c3a1-4e32-947e-ec7270830fcf 68382-309 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20170215 ANDA ANDA089884 Zydus Pharmaceuticals (USA) Inc. NITROGLYCERIN .2 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68382-310_53dbb9b9-c3a1-4e32-947e-ec7270830fcf 68382-310 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20170215 ANDA ANDA089885 Zydus Pharmaceuticals (USA) Inc. NITROGLYCERIN .4 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68382-311_53dbb9b9-c3a1-4e32-947e-ec7270830fcf 68382-311 HUMAN PRESCRIPTION DRUG Nitroglycerin Transdermal System Nitroglycerin Transdermal System PATCH, EXTENDED RELEASE TRANSDERMAL 20170215 ANDA ANDA089886 Zydus Pharmaceuticals (USA) Inc. NITROGLYCERIN .6 mg/h Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68382-314_05049a94-35d2-78c0-7a51-4a24c109afbc 68382-314 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20000804 NDA AUTHORIZED GENERIC NDA021168 Zydus Pharmaceuticals USA Inc DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-315_05049a94-35d2-78c0-7a51-4a24c109afbc 68382-315 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20130812 NDA AUTHORIZED GENERIC NDA021168 Zydus Pharmaceuticals USA Inc DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68382-316_093e5221-e8e6-46ab-a8f6-35ace80aafbb 68382-316 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20170403 ANDA ANDA063011 Zydus Pharmaceuticals (USA) Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68382-317_093e5221-e8e6-46ab-a8f6-35ace80aafbb 68382-317 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20170403 ANDA ANDA063009 Zydus Pharmaceuticals (USA) Inc. MINOCYCLINE HYDROCHLORIDE 75 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68382-318_093e5221-e8e6-46ab-a8f6-35ace80aafbb 68382-318 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20170403 ANDA ANDA063009 Zydus Pharmaceuticals (USA) Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68382-319_2c13222c-de95-4872-a383-ea1657c4a8d5 68382-319 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20110131 ANDA ANDA090404 Zydus Pharmaceuticals (USA) Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68382-320_ad62eec5-d353-4ea2-7e34-173c7b7fa522 68382-320 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170601 NDA AUTHORIZED GENERIC NDA018279 Zydus Pharmaceuticals USA Inc POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68382-334_2182fa04-4d8a-4ce1-a027-1ae4ef9e1dbb 68382-334 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20121015 ANDA ANDA090460 Zydus Pharmaceuticals (USA) Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68382-338_1782b089-75a4-42ee-8a2c-aea4ba34070f 68382-338 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68382-339_1782b089-75a4-42ee-8a2c-aea4ba34070f 68382-339 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68382-340_1782b089-75a4-42ee-8a2c-aea4ba34070f 68382-340 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68382-341_1782b089-75a4-42ee-8a2c-aea4ba34070f 68382-341 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68382-342_1782b089-75a4-42ee-8a2c-aea4ba34070f 68382-342 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68382-343_1782b089-75a4-42ee-8a2c-aea4ba34070f 68382-343 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68382-344_1782b089-75a4-42ee-8a2c-aea4ba34070f 68382-344 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20090923 ANDA ANDA090411 Zydus Pharmaceuticals (USA) Inc. ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68382-346_4992cf86-442f-4749-9658-c6dddbba8033 68382-346 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA090175 Zydus Pharmaceuticals (USA) Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68382-347_4992cf86-442f-4749-9658-c6dddbba8033 68382-347 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, ORALLY DISINTEGRATING ORAL 20110511 ANDA ANDA090175 Zydus Pharmaceuticals (USA) Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68382-354_4a65e110-261d-431b-ba2a-3abf6da03a79 68382-354 HUMAN PRESCRIPTION DRUG bupropion bupropion TABLET, EXTENDED RELEASE ORAL 20140215 ANDA ANDA201567 Zydus Pharmaceuticals (USA) Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68382-363_a7dfded8-37bd-4d82-afff-2065e6ba24a8 68382-363 HUMAN PRESCRIPTION DRUG letrozole letrozole TABLET, FILM COATED ORAL 20110603 ANDA ANDA090405 Zydus Pharmaceuticals (USA) Inc. LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 68382-370_927d7e77-9d9f-4ddb-92ee-ecd3bf12bf6f 68382-370 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20170608 ANDA ANDA208581 Zydus Pharmaceuticals (USA) Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 68382-374_2881c50d-8a1c-4bae-b4e9-103c3b560f7e 68382-374 HUMAN PRESCRIPTION DRUG Ramipril Ramipril TABLET ORAL 20171205 ANDA ANDA090697 Zydus Pharmaceuticals (USA) Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68382-375_2881c50d-8a1c-4bae-b4e9-103c3b560f7e 68382-375 HUMAN PRESCRIPTION DRUG Ramipril Ramipril TABLET ORAL 20171205 ANDA ANDA090697 Zydus Pharmaceuticals (USA) Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68382-376_2881c50d-8a1c-4bae-b4e9-103c3b560f7e 68382-376 HUMAN PRESCRIPTION DRUG Ramipril Ramipril TABLET ORAL 20171205 ANDA ANDA090697 Zydus Pharmaceuticals (USA) Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68382-377_2881c50d-8a1c-4bae-b4e9-103c3b560f7e 68382-377 HUMAN PRESCRIPTION DRUG Ramipril Ramipril TABLET ORAL 20171205 ANDA ANDA090697 Zydus Pharmaceuticals (USA) Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68382-384_9e5f9f63-46c7-4d0f-8ca9-f5f536bf5c05 68382-384 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate SPRAY NASAL 20180201 ANDA ANDA091345 Zydus Pharmaceuticals (USA) Inc. DESMOPRESSIN ACETATE .1 mg/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20191231 68382-385_23e09bf2-3188-4087-831d-bf8cae89f5e0 68382-385 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Zydus Pharmaceuticals (USA) Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68382-386_23e09bf2-3188-4087-831d-bf8cae89f5e0 68382-386 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Zydus Pharmaceuticals (USA) Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68382-387_23e09bf2-3188-4087-831d-bf8cae89f5e0 68382-387 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20140527 ANDA ANDA090739 Zydus Pharmaceuticals (USA) Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68382-388_a3403c73-d3aa-408f-a82c-f3fc243639ab 68382-388 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20170928 ANDA ANDA090961 Zydus Pharmaceuticals (USA) Inc. MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 68382-389_a3403c73-d3aa-408f-a82c-f3fc243639ab 68382-389 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20170928 ANDA ANDA090961 Zydus Pharmaceuticals (USA) Inc. MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 68382-395_0028a8d7-5329-4faf-a7e0-ba3abb26b9b4 68382-395 HUMAN PRESCRIPTION DRUG RIBAVIRIN ribavirin POWDER, FOR SOLUTION RESPIRATORY (INHALATION) 20161215 ANDA ANDA207366 Zydus Pharmaceuticals USA Inc. RIBAVIRIN 6 g/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20191231 68382-396_e99193a4-96eb-4950-af3c-b3acc42dae59 68382-396 HUMAN PRESCRIPTION DRUG SODIUM PHENYLACETATE AND SODIUM BENZOATE sodium phenylacetate and sodium benzoate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20160901 ANDA ANDA205880 Zydus Pharmaceuticals USA Inc. SODIUM PHENYLACETATE; SODIUM BENZOATE 100; 100 mg/mL; mg/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20191231 68382-398_ad62eec5-d353-4ea2-7e34-173c7b7fa522 68382-398 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140116 NDA AUTHORIZED GENERIC NDA018279 Zydus Pharmaceuticals USA Inc POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68382-411_bcb7acbd-453b-4fc8-be74-1ba3225cab7b 68382-411 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20121123 ANDA ANDA091352 Zydus Pharmaceuticals (USA) Inc. OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 68382-412_bcb7acbd-453b-4fc8-be74-1ba3225cab7b 68382-412 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20121123 ANDA ANDA091352 Zydus Pharmaceuticals (USA) Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 68382-413_ad2c2d31-9a3c-45a1-82d4-b30e7de346a8 68382-413 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20170809 ANDA ANDA206097 Zydus Pharmaceuticals (USA) Inc. LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 68382-415_a6baf17d-2c09-4560-8207-b4a48cec2295 68382-415 HUMAN PRESCRIPTION DRUG AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE SPRAY, METERED NASAL 20180201 ANDA ANDA091409 Zydus Pharmaceuticals (USA) Inc. AZELASTINE HYDROCHLORIDE 137 ug/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 68382-418_f98fc905-f9bc-4237-b193-e5be2977df46 68382-418 HUMAN OTC DRUG OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED NASAL 20090924 OTC MONOGRAPH NOT FINAL part341 Zydus Pharmaceuticals (USA) Inc. OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL E 20171231 68382-422_9da774ea-72db-4249-8efa-ccd02e0fa94a 68382-422 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20130301 ANDA ANDA091534 Zydus Pharmaceuticals (USA) Inc. RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68382-423_9da774ea-72db-4249-8efa-ccd02e0fa94a 68382-423 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20130301 ANDA ANDA091534 Zydus Pharmaceuticals (USA) Inc. RANITIDINE HYDROCHLORIDE 25 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68382-443_f4d37571-27b3-4d2b-a211-c21491d75718 68382-443 HUMAN PRESCRIPTION DRUG ethosuximide ethosuximide CAPSULE ORAL 20121010 ANDA ANDA200892 Zydus Pharmaceuticals (USA) Inc. ETHOSUXIMIDE 250 1/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 68382-444_a8010e10-68fd-455f-968f-d62a1c3e0ffd 68382-444 HUMAN PRESCRIPTION DRUG Famotidine Famotidine POWDER, FOR SUSPENSION ORAL 20100527 ANDA ANDA091020 Zydus Pharmaceuticals USA Inc FAMOTIDINE 40 mg/5mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 68382-470_472dda1f-ad6d-4a6c-a9a6-43a951a0c715 68382-470 HUMAN PRESCRIPTION DRUG INDOMETHACIN INDOMETHACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171003 ANDA ANDA206561 Zydus Pharmaceuticals USA Inc. INDOMETHACIN SODIUM 1 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68382-471_48ddbda9-9607-4725-a379-0c952b5355f2 68382-471 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20140827 ANDA ANDA203325 Zydus Pharmaceuticals (USA) Inc. TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-472_48ddbda9-9607-4725-a379-0c952b5355f2 68382-472 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20140827 ANDA ANDA203325 Zydus Pharmaceuticals (USA) Inc. TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-473_48ddbda9-9607-4725-a379-0c952b5355f2 68382-473 HUMAN PRESCRIPTION DRUG telmisartan telmisartan TABLET ORAL 20140827 ANDA ANDA203325 Zydus Pharmaceuticals (USA) Inc. TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-479_ca5e84d8-caed-497a-8a7d-5e3e8543b778 68382-479 HUMAN PRESCRIPTION DRUG fesoterodine fumarate fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171207 ANDA ANDA204946 Zydus Pharmaceuticals (USA) Inc. FESOTERODINE FUMARATE 4 mg/1 N 20181231 68382-480_ca5e84d8-caed-497a-8a7d-5e3e8543b778 68382-480 HUMAN PRESCRIPTION DRUG fesoterodine fumarate fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171207 ANDA ANDA204946 Zydus Pharmaceuticals (USA) Inc. FESOTERODINE FUMARATE 8 mg/1 N 20181231 68382-484_0325121b-d673-4251-8d7d-f9e79869afe8 68382-484 HUMAN PRESCRIPTION DRUG mesalamine mesalamine TABLET, DELAYED RELEASE ORAL 20160801 NDA AUTHORIZED GENERIC NDA021830 Zydus Pharmaceuticals (USA) Inc. MESALAMINE 800 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 68382-500_bcb7acbd-453b-4fc8-be74-1ba3225cab7b 68382-500 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20121123 ANDA ANDA091352 Zydus Pharmaceuticals (USA) Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 68382-512_23ab8f3a-f9f9-4975-af55-98c246fab1b5 68382-512 HUMAN PRESCRIPTION DRUG amantadine hydrochloride amantadine hydrochloride CAPSULE ORAL 20160804 ANDA ANDA208278 Zydus Pharmaceuticals (USA) Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 68382-513_51a21fac-fe7e-4e19-ac6a-9274d581a04e 68382-513 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20171012 ANDA ANDA204221 Zydus Pharmaceuticals (USA) Inc. TELMISARTAN; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68382-514_51a21fac-fe7e-4e19-ac6a-9274d581a04e 68382-514 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20171012 ANDA ANDA204221 Zydus Pharmaceuticals (USA) Inc. TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68382-515_51a21fac-fe7e-4e19-ac6a-9274d581a04e 68382-515 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20171012 ANDA ANDA204221 Zydus Pharmaceuticals (USA) Inc. TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68382-520_63b7d21c-bc87-468b-a4a5-ea4fb374714f 68382-520 HUMAN PRESCRIPTION DRUG sirolimus sirolimus TABLET, FILM COATED ORAL 20140115 ANDA ANDA201676 Zydus Pharmaceuticals (USA) Inc. SIROLIMUS .5 mg/1 Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 68382-529_6f042e1e-0693-4100-a9f2-06b28622a9b5 68382-529 HUMAN PRESCRIPTION DRUG CHOLESTYRAMINE CHOLESTYRAMINE POWDER, FOR SUSPENSION ORAL 20170608 ANDA ANDA202902 Zydus Pharmaceuticals (USA) Inc. CHOLESTYRAMINE 4 g/5.5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 68382-530_bffd61d6-af2e-46ae-bbca-96f150483953 68382-530 HUMAN PRESCRIPTION DRUG Diflunisal Diflunisal TABLET ORAL 20170914 ANDA ANDA203547 Zydus Pharmaceuticals (USA) Inc. DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68382-536_df4421ad-772d-46cf-9fe9-c1b58060706a 68382-536 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20140812 ANDA ANDA203546 Zydus Pharmaceuticals (USA) Inc. POTASSIUM CITRATE 5 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 68382-537_df4421ad-772d-46cf-9fe9-c1b58060706a 68382-537 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20140812 ANDA ANDA203546 Zydus Pharmaceuticals (USA) Inc. POTASSIUM CITRATE 10 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 68382-538_df4421ad-772d-46cf-9fe9-c1b58060706a 68382-538 HUMAN PRESCRIPTION DRUG Potassium Citrate Potassium Citrate TABLET, EXTENDED RELEASE ORAL 20140812 ANDA ANDA203546 Zydus Pharmaceuticals (USA) Inc. POTASSIUM CITRATE 15 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 68382-539_67168c4b-70e9-4e95-b07f-8d04e051399b 68382-539 HUMAN PRESCRIPTION DRUG CALCIUM ACETATE CALCIUM ACETATE CAPSULE ORAL 20150707 ANDA ANDA202315 Zydus Pharmaceuticals USA Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 68382-543_58458b05-64a4-4bff-b943-9f207494bde9 68382-543 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130823 ANDA ANDA202366 Zydus Pharmaceuticals (USA) Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68382-544_58458b05-64a4-4bff-b943-9f207494bde9 68382-544 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130823 ANDA ANDA202366 Zydus Pharmaceuticals (USA) Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68382-545_e01df60d-670d-44dd-93e3-d4720d210eec 68382-545 HUMAN PRESCRIPTION DRUG etomidate etomidate INJECTION, SOLUTION INTRAVENOUS 20150403 ANDA ANDA202360 Zydus Pharmaceuticals (USA) Inc. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 68382-569_fd2af2f5-8924-4fbb-bb50-c233640c33fa 68382-569 HUMAN PRESCRIPTION DRUG acamprosate calcium acamprosate calcium TABLET, DELAYED RELEASE ORAL 20170601 ANDA ANDA205995 Zydus Pharmaceuticals (USA) Inc. ACAMPROSATE CALCIUM 333 mg/1 N 20181231 68382-595_7b949eee-7a9b-47df-bf55-4d277525eb4b 68382-595 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170928 ANDA ANDA206534 Zydus Pharmaceuticals (USA) Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68382-596_7b949eee-7a9b-47df-bf55-4d277525eb4b 68382-596 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170928 ANDA ANDA206534 Zydus Pharmaceuticals (USA) Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68382-597_7b949eee-7a9b-47df-bf55-4d277525eb4b 68382-597 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170928 ANDA ANDA206534 Zydus Pharmaceuticals (USA) Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68382-598_7b949eee-7a9b-47df-bf55-4d277525eb4b 68382-598 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170928 ANDA ANDA206534 Zydus Pharmaceuticals (USA) Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68382-599_7b949eee-7a9b-47df-bf55-4d277525eb4b 68382-599 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170928 ANDA ANDA206534 Zydus Pharmaceuticals (USA) Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68382-600_ad62eec5-d353-4ea2-7e34-173c7b7fa522 68382-600 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110222 NDA AUTHORIZED GENERIC NDA018279 Zydus Pharmaceuticals USA Inc POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68382-601_2aa46cbe-8a53-40a6-8849-64b10d30189f 68382-601 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride INJECTION, SOLUTION EPIDURAL 20180131 ANDA ANDA202601 Zydus Pharmaceuticals (USA) Inc. CLONIDINE HYDROCHLORIDE .1 mg/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68382-602_2aa46cbe-8a53-40a6-8849-64b10d30189f 68382-602 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride INJECTION, SOLUTION EPIDURAL 20180131 ANDA ANDA202601 Zydus Pharmaceuticals (USA) Inc. CLONIDINE HYDROCHLORIDE .5 mg/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68382-618_57ef565a-d2a7-4cbd-90dc-02b1c741b9e8 68382-618 HUMAN PRESCRIPTION DRUG aspirin-dipyridamole aspirin-dipyridamole CAPSULE ORAL 20180104 ANDA ANDA206753 Zydus Pharmaceuticals (USA) Inc. ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 68382-642_71154665-be56-47ef-8f1f-5997a6f86b2a 68382-642 HUMAN PRESCRIPTION DRUG CALCIUM ACETATE CALCIUM ACETATE TABLET ORAL 20120223 ANDA ANDA202885 Zydus Pharmaceuticals USA Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 68382-643_c7e9e790-f5eb-4fc2-8e80-d603e8e28074 68382-643 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA205192 Zydus Pharmaceuticals (USA) Inc. OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-644_c7e9e790-f5eb-4fc2-8e80-d603e8e28074 68382-644 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA205192 Zydus Pharmaceuticals (USA) Inc. OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-645_c7e9e790-f5eb-4fc2-8e80-d603e8e28074 68382-645 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA205192 Zydus Pharmaceuticals (USA) Inc. OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-649_a36f984b-ec56-40fd-802d-5ee5a8ce6f08 68382-649 HUMAN PRESCRIPTION DRUG mesalamine mesalamine TABLET, DELAYED RELEASE ORAL 20160801 NDA AUTHORIZED GENERIC NDA021830 Zydus Pharmaceuticals (USA) Inc. MESALAMINE 800 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 68382-650_38b3edc6-8b4d-4855-8527-2229aadee33c 68382-650 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET ORAL 20131219 ANDA ANDA075395 Zydus Pharmaceuticals (USA) Inc. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68382-651_38b3edc6-8b4d-4855-8527-2229aadee33c 68382-651 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET ORAL 20131219 ANDA ANDA075395 Zydus Pharmaceuticals (USA) Inc. ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68382-652_38b3edc6-8b4d-4855-8527-2229aadee33c 68382-652 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET ORAL 20131219 ANDA ANDA075395 Zydus Pharmaceuticals (USA) Inc. ISOSORBIDE MONONITRATE 120 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68382-653_03bd9652-8fbe-455a-ab92-e90f973ea16a 68382-653 HUMAN PRESCRIPTION DRUG glyburide and metformin hydrochloride glyburide and metformin hydrochloride TABLET ORAL 20160407 ANDA ANDA206748 Zydus Pharmaceuticals (USA) Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25; 250 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-654_03bd9652-8fbe-455a-ab92-e90f973ea16a 68382-654 HUMAN PRESCRIPTION DRUG glyburide and metformin hydrochloride glyburide and metformin hydrochloride TABLET ORAL 20160407 ANDA ANDA206748 Zydus Pharmaceuticals (USA) Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-655_03bd9652-8fbe-455a-ab92-e90f973ea16a 68382-655 HUMAN PRESCRIPTION DRUG glyburide and metformin hydrochloride glyburide and metformin hydrochloride TABLET ORAL 20160407 ANDA ANDA206748 Zydus Pharmaceuticals (USA) Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-656_35490968-2356-44b2-8a41-d17c1dc9b8ae 68382-656 HUMAN PRESCRIPTION DRUG glyburide glyburide TABLET ORAL 20160602 ANDA ANDA206749 Zydus Pharmaceuticals (USA) Inc. GLYBURIDE 1.25 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68382-657_35490968-2356-44b2-8a41-d17c1dc9b8ae 68382-657 HUMAN PRESCRIPTION DRUG glyburide glyburide TABLET ORAL 20160602 ANDA ANDA206749 Zydus Pharmaceuticals (USA) Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68382-658_35490968-2356-44b2-8a41-d17c1dc9b8ae 68382-658 HUMAN PRESCRIPTION DRUG glyburide glyburide TABLET ORAL 20160602 ANDA ANDA206749 Zydus Pharmaceuticals (USA) Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68382-659_70ca32f1-d6ca-43d7-9dde-0925a9549dca 68382-659 HUMAN PRESCRIPTION DRUG pyridostigmine bromide pyridostigmine bromide TABLET ORAL 20150807 ANDA ANDA205650 Zydus Pharmaceuticals (USA) Inc. PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68382-668_beded6e9-8043-4b8f-a048-4ebb0a6be58e 68382-668 HUMAN PRESCRIPTION DRUG acyclovir acyclovir CAPSULE ORAL 20160503 ANDA ANDA204313 Zydus Pharmaceuticals (USA) Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68382-669_63ed8b21-9093-4787-845f-0dd5ddd06be6 68382-669 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170922 ANDA ANDA204473 Zydus Pharmaceuticals (USA) Inc. MYCOPHENOLATE MOFETIL 500 mg/20mL Antimetabolite Immunosuppressant [EPC] N 20181231 68382-676_5d19659b-0189-40d3-a940-6772e1c7fdd0 68382-676 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20170720 ANDA ANDA205798 Zydus Pharmaceuticals (USA) Inc. MIRTAZAPINE 30 mg/1 N 20181231 68382-677_5d19659b-0189-40d3-a940-6772e1c7fdd0 68382-677 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20170720 ANDA ANDA205798 Zydus Pharmaceuticals (USA) Inc. MIRTAZAPINE 15 mg/1 N 20181231 68382-679_5d19659b-0189-40d3-a940-6772e1c7fdd0 68382-679 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20170720 ANDA ANDA205798 Zydus Pharmaceuticals (USA) Inc. MIRTAZAPINE 45 mg/1 N 20181231 68382-685_65eaffeb-34cb-4b8e-ac16-c38a08ce9e02 68382-685 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20180202 ANDA ANDA210012 Zydus Pharmaceuticals (USA) Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68382-686_65eaffeb-34cb-4b8e-ac16-c38a08ce9e02 68382-686 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20180202 ANDA ANDA210012 Zydus Pharmaceuticals (USA) Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68382-687_65eaffeb-34cb-4b8e-ac16-c38a08ce9e02 68382-687 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20180202 ANDA ANDA210012 Zydus Pharmaceuticals (USA) Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68382-701_cef5fc1e-5f65-47ab-8d6b-38ce1f777a39 68382-701 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20101025 NDA AUTHORIZED GENERIC NDA018238 Zydus Pharmaceuticals (USA) Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68382-702_cef5fc1e-5f65-47ab-8d6b-38ce1f777a39 68382-702 HUMAN PRESCRIPTION DRUG POTASSIUM CHLORIDE potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20101025 NDA AUTHORIZED GENERIC NDA018238 Zydus Pharmaceuticals (USA) Inc. POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68382-706_ce8ede5b-a715-4836-886b-38a8705b41ff 68382-706 HUMAN PRESCRIPTION DRUG doxycycline doxycycline CAPSULE ORAL 20160314 ANDA ANDA205115 Zydus Pharmaceuticals (USA) Inc. DOXYCYCLINE 75 mg/1 N 20181231 68382-707_ce8ede5b-a715-4836-886b-38a8705b41ff 68382-707 HUMAN PRESCRIPTION DRUG doxycycline doxycycline CAPSULE ORAL 20160314 ANDA ANDA205115 Zydus Pharmaceuticals (USA) Inc. DOXYCYCLINE 100 mg/1 N 20181231 68382-711_3532cf53-602f-4028-a967-9211a19ddc27 68382-711 HUMAN PRESCRIPTION DRUG mesalamine mesalamine TABLET, DELAYED RELEASE ORAL 20170619 ANDA ANDA091640 Zydus Pharmaceuticals (USA) Inc. MESALAMINE 1.2 g/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 68382-715_b2708536-6e51-4fc0-89b7-98fedc8be2ce 68382-715 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130516 ANDA ANDA202890 Zydus Pharmaceuticals (USA) Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68382-717_b2708536-6e51-4fc0-89b7-98fedc8be2ce 68382-717 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130516 ANDA ANDA202890 Zydus Pharmaceuticals (USA) Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68382-720_34d31382-f546-4d0f-a4f3-fa4d596d91de 68382-720 HUMAN PRESCRIPTION DRUG budesonide budesonide CAPSULE, COATED PELLETS ORAL 20170608 ANDA ANDA206134 Zydus Pharmaceuticals (USA) Inc. BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68382-721_a38f6a32-c1ee-43dc-aa96-f7b78e4d5a29 68382-721 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, FILM COATED ORAL 20161027 ANDA ANDA205248 Zydus Pharmaceuticals (USA) Inc. NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 68382-722_a38f6a32-c1ee-43dc-aa96-f7b78e4d5a29 68382-722 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, FILM COATED ORAL 20161027 ANDA ANDA205248 Zydus Pharmaceuticals (USA) Inc. NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 68382-732_7af9efa7-8f8d-4ed1-a41f-79165f1f5a46 68382-732 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20170808 ANDA ANDA207761 Zydus Pharmaceuticals (USA) Inc. NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-733_7af9efa7-8f8d-4ed1-a41f-79165f1f5a46 68382-733 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20170808 ANDA ANDA207761 Zydus Pharmaceuticals (USA) Inc. NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-734_7af9efa7-8f8d-4ed1-a41f-79165f1f5a46 68382-734 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20170808 ANDA ANDA207761 Zydus Pharmaceuticals (USA) Inc. NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-735_619a5fe3-8b66-42c7-a17f-a4196004bdae 68382-735 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET ORAL 20160525 ANDA ANDA206747 Zydus Pharmaceuticals (USA) Inc. VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68382-736_619a5fe3-8b66-42c7-a17f-a4196004bdae 68382-736 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET ORAL 20160525 ANDA ANDA206747 Zydus Pharmaceuticals (USA) Inc. VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68382-745_ecd33022-1743-4954-8674-f661987752c0 68382-745 HUMAN PRESCRIPTION DRUG TIADYLT ER diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA206641 Zydus Pharmaceuticals (USA) Inc. DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68382-746_ecd33022-1743-4954-8674-f661987752c0 68382-746 HUMAN PRESCRIPTION DRUG TIADYLT ER diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA206641 Zydus Pharmaceuticals (USA) Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68382-747_ecd33022-1743-4954-8674-f661987752c0 68382-747 HUMAN PRESCRIPTION DRUG TIADYLT ER diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA206641 Zydus Pharmaceuticals (USA) Inc. DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68382-748_ecd33022-1743-4954-8674-f661987752c0 68382-748 HUMAN PRESCRIPTION DRUG TIADYLT ER diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA206641 Zydus Pharmaceuticals (USA) Inc. DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68382-749_ecd33022-1743-4954-8674-f661987752c0 68382-749 HUMAN PRESCRIPTION DRUG TIADYLT ER diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA206641 Zydus Pharmaceuticals (USA) Inc. DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68382-750_ecd33022-1743-4954-8674-f661987752c0 68382-750 HUMAN PRESCRIPTION DRUG TIADYLT ER diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA206641 Zydus Pharmaceuticals (USA) Inc. DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68382-751_4c0d8d72-a949-44b9-b60c-aaf3d7a2400e 68382-751 HUMAN PRESCRIPTION DRUG temozolomide temozolomide CAPSULE ORAL 20171026 ANDA ANDA206750 Zydus Pharmaceuticals (USA) Inc. TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 68382-752_4c0d8d72-a949-44b9-b60c-aaf3d7a2400e 68382-752 HUMAN PRESCRIPTION DRUG temozolomide temozolomide CAPSULE ORAL 20171026 ANDA ANDA206750 Zydus Pharmaceuticals (USA) Inc. TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 68382-753_4c0d8d72-a949-44b9-b60c-aaf3d7a2400e 68382-753 HUMAN PRESCRIPTION DRUG temozolomide temozolomide CAPSULE ORAL 20171026 ANDA ANDA206750 Zydus Pharmaceuticals (USA) Inc. TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 68382-754_4c0d8d72-a949-44b9-b60c-aaf3d7a2400e 68382-754 HUMAN PRESCRIPTION DRUG temozolomide temozolomide CAPSULE ORAL 20171026 ANDA ANDA206750 Zydus Pharmaceuticals (USA) Inc. TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 68382-755_4c0d8d72-a949-44b9-b60c-aaf3d7a2400e 68382-755 HUMAN PRESCRIPTION DRUG temozolomide temozolomide CAPSULE ORAL 20171026 ANDA ANDA206750 Zydus Pharmaceuticals (USA) Inc. TEMOZOLOMIDE 180 1/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 68382-756_4c0d8d72-a949-44b9-b60c-aaf3d7a2400e 68382-756 HUMAN PRESCRIPTION DRUG temozolomide temozolomide CAPSULE ORAL 20171026 ANDA ANDA206750 Zydus Pharmaceuticals (USA) Inc. TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 68382-758_50ab0e8f-2d25-477d-875a-652fefd827ab 68382-758 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-759_50ab0e8f-2d25-477d-875a-652fefd827ab 68382-759 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-760_50ab0e8f-2d25-477d-875a-652fefd827ab 68382-760 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Zydus Pharmaceuticals (USA) Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68382-773_f94b0d30-9b8a-4ec4-a185-6b817b68809f 68382-773 HUMAN PRESCRIPTION DRUG ezetimibe ezetimibe TABLET ORAL 20170809 ANDA ANDA204331 Zydus Pharmaceuticals (USA) Inc. EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 68382-775_7e49206c-de28-43ac-8fbf-8bab5b40819c 68382-775 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate TABLET ORAL 20170209 ANDA ANDA207812 Zydus Pharmaceuticals (USA) Inc. METHOTREXATE 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 68382-776_ad62eec5-d353-4ea2-7e34-173c7b7fa522 68382-776 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140116 NDA AUTHORIZED GENERIC NDA018279 Zydus Pharmaceuticals USA Inc POTASSIUM CHLORIDE 600 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68382-782_ce8ede5b-a715-4836-886b-38a8705b41ff 68382-782 HUMAN PRESCRIPTION DRUG doxycycline doxycycline CAPSULE ORAL 20160314 ANDA ANDA205115 Zydus Pharmaceuticals (USA) Inc. DOXYCYCLINE 50 mg/1 N 20181231 68382-783_a308818e-e36c-4431-bf51-274650c38cb0 68382-783 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20170831 ANDA ANDA208719 Zydus Pharmaceuticals (USA) Inc. DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68382-784_a308818e-e36c-4431-bf51-274650c38cb0 68382-784 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20170831 ANDA ANDA208719 Zydus Pharmaceuticals (USA) Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68382-785_a308818e-e36c-4431-bf51-274650c38cb0 68382-785 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20170831 ANDA ANDA208719 Zydus Pharmaceuticals (USA) Inc. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68382-786_a308818e-e36c-4431-bf51-274650c38cb0 68382-786 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20170831 ANDA ANDA208719 Zydus Pharmaceuticals (USA) Inc. DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68382-791_ee7afbc4-5ccb-4513-94a2-5f8e5406d402 68382-791 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Zydus Pharmaceuticals (USA) Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68382-792_ee7afbc4-5ccb-4513-94a2-5f8e5406d402 68382-792 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Zydus Pharmaceuticals (USA) Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68382-793_6e5a4e4a-529c-4f7b-adc7-3592446c6840 68382-793 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 68382-794_6e5a4e4a-529c-4f7b-adc7-3592446c6840 68382-794 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 68382-795_6e5a4e4a-529c-4f7b-adc7-3592446c6840 68382-795 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 68382-796_6e5a4e4a-529c-4f7b-adc7-3592446c6840 68382-796 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE 20 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 68382-797_6e5a4e4a-529c-4f7b-adc7-3592446c6840 68382-797 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 68382-798_e4f35d97-b2d3-4f31-9606-fd9d85b6cf7b 68382-798 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 ANDA ANDA207743 Zydus Pharmaceuticals (USA) Inc. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-799_e4f35d97-b2d3-4f31-9606-fd9d85b6cf7b 68382-799 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 ANDA ANDA207743 Zydus Pharmaceuticals (USA) Inc. LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-800_e4f35d97-b2d3-4f31-9606-fd9d85b6cf7b 68382-800 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 ANDA ANDA207743 Zydus Pharmaceuticals (USA) Inc. LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68382-805_288890b7-bcd6-4e8e-a437-ac5cd56b27be 68382-805 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20171211 ANDA ANDA205253 Zydus Pharmaceuticals (USA) Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68382-806_288890b7-bcd6-4e8e-a437-ac5cd56b27be 68382-806 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20171211 ANDA ANDA205253 Zydus Pharmaceuticals (USA) Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68382-807_288890b7-bcd6-4e8e-a437-ac5cd56b27be 68382-807 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20171211 ANDA ANDA205253 Zydus Pharmaceuticals (USA) Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68382-808_288890b7-bcd6-4e8e-a437-ac5cd56b27be 68382-808 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20171211 ANDA ANDA205253 Zydus Pharmaceuticals (USA) Inc. TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68382-826_f1366a22-5b47-406d-85e5-20cf8e1eeac5 68382-826 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20180103 ANDA ANDA206694 Zydus Pharmaceuticals (USA) Inc. TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 68382-827_f1366a22-5b47-406d-85e5-20cf8e1eeac5 68382-827 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20180103 ANDA ANDA206694 Zydus Pharmaceuticals (USA) Inc. TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 68382-850_d20a87c8-2d28-40a9-a58f-1203cb13b955 68382-850 HUMAN PRESCRIPTION DRUG metronidazole metronidazole TABLET ORAL 20170119 ANDA ANDA206560 Zydus Pharmaceuticals (USA) Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68382-851_d20a87c8-2d28-40a9-a58f-1203cb13b955 68382-851 HUMAN PRESCRIPTION DRUG metronidazole metronidazole TABLET ORAL 20170119 ANDA ANDA206560 Zydus Pharmaceuticals (USA) Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68382-860_f49d05fe-1655-40e6-960c-cef8aeb2bbc8 68382-860 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate INJECTION INTRAMUSCULAR; INTRAVENOUS 20170608 ANDA ANDA091525 Zydus Pharmaceuticals USA Inc. BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20191231 68382-889_2ca399d3-9c10-4108-91fa-78eec6d81a73 68382-889 HUMAN PRESCRIPTION DRUG desoximetasone desoximetasone OINTMENT TOPICAL 20171205 ANDA ANDA205206 Zydus Pharmaceuticals (USA) Inc. DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68382-891_ffde9fc6-c9a3-4790-9ed2-29fb3a5c65c1 68382-891 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION INTRAVENOUS 20171004 ANDA ANDA205228 Zydus Pharmaceuticals (USA) Inc. TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 68382-903_1cd95c87-5a65-4ee9-8b79-b9df52e944bc 68382-903 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20150709 ANDA ANDA076733 Zydus Pharmaceuticals (USA) Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 68382-904_1cd95c87-5a65-4ee9-8b79-b9df52e944bc 68382-904 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20150709 ANDA ANDA076720 Zydus Pharmaceuticals (USA) Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 68382-905_1cd95c87-5a65-4ee9-8b79-b9df52e944bc 68382-905 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20150709 ANDA ANDA076720 Zydus Pharmaceuticals (USA) Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 68382-906_1cd95c87-5a65-4ee9-8b79-b9df52e944bc 68382-906 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20150709 ANDA ANDA077855 Zydus Pharmaceuticals (USA) Inc. MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 68382-907_1cd95c87-5a65-4ee9-8b79-b9df52e944bc 68382-907 HUMAN PRESCRIPTION DRUG MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE ORAL 20150709 ANDA ANDA077855 Zydus Pharmaceuticals (USA) Inc. MORPHINE SULFATE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20191231 68382-910_f24f7956-176b-422e-9d9d-568ee993b355 68382-910 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20180201 ANDA ANDA207757 Zydus Pharmaceuticals (USA) Inc. DOXYCYCLINE HYCLATE 100 mg/10mL N 20181231 68382-911_f24f7956-176b-422e-9d9d-568ee993b355 68382-911 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20180201 ANDA ANDA207757 Zydus Pharmaceuticals (USA) Inc. DOXYCYCLINE HYCLATE 200 mg/20mL N 20181231 68382-920_23fe4300-bf01-403b-8b1c-ff877aba62be 68382-920 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20170810 ANDA ANDA206745 Zydus Pharmaceuticals (USA) Inc. ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68382-921_23fe4300-bf01-403b-8b1c-ff877aba62be 68382-921 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20170810 ANDA ANDA206745 Zydus Pharmaceuticals (USA) Inc. ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68382-922_21c04c59-43e9-4615-ad81-c8c2c6d4d132 68382-922 HUMAN PRESCRIPTION DRUG Eletriptan hydrobromide Eletriptan hydrobromide TABLET, FILM COATED ORAL 20170712 ANDA ANDA206409 Zydus Pharmaceuticals (USA) Inc. ELETRIPTAN HYDROBROMIDE 20 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68382-923_21c04c59-43e9-4615-ad81-c8c2c6d4d132 68382-923 HUMAN PRESCRIPTION DRUG Eletriptan hydrobromide Eletriptan hydrobromide TABLET, FILM COATED ORAL 20170712 ANDA ANDA206409 Zydus Pharmaceuticals (USA) Inc. ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68382-927_b73771e5-2b19-4fda-8397-24f89a5f8b0f 68382-927 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil TABLET, FILM COATED ORAL 20180104 ANDA ANDA207771 Zydus Pharmaceuticals (USA) Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-928_b73771e5-2b19-4fda-8397-24f89a5f8b0f 68382-928 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil TABLET, FILM COATED ORAL 20180104 ANDA ANDA207771 Zydus Pharmaceuticals (USA) Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-929_b73771e5-2b19-4fda-8397-24f89a5f8b0f 68382-929 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil TABLET, FILM COATED ORAL 20180104 ANDA ANDA207771 Zydus Pharmaceuticals (USA) Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-930_b73771e5-2b19-4fda-8397-24f89a5f8b0f 68382-930 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil TABLET, FILM COATED ORAL 20180104 ANDA ANDA207771 Zydus Pharmaceuticals (USA) Inc. AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68382-941_ad840fb3-5860-447a-8ad3-61c29d883733 68382-941 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET ORAL 20160328 ANDA ANDA206588 Zydus Pharmaceuticals (USA) Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68382-942_ad840fb3-5860-447a-8ad3-61c29d883733 68382-942 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET ORAL 20160328 ANDA ANDA206588 Zydus Pharmaceuticals (USA) Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68382-943_4e58fbe2-6f65-4307-9e3e-bb22f3b18b80 68382-943 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20170628 ANDA ANDA209111 Zydus Pharmaceuticals (USA) Inc. DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68382-944_4e58fbe2-6f65-4307-9e3e-bb22f3b18b80 68382-944 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20170628 ANDA ANDA209111 Zydus Pharmaceuticals (USA) Inc. DEXTROAMPHETAMINE SULFATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68382-945_4e58fbe2-6f65-4307-9e3e-bb22f3b18b80 68382-945 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20170628 ANDA ANDA209111 Zydus Pharmaceuticals (USA) Inc. DEXTROAMPHETAMINE SULFATE 15 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68382-950_e926f28c-792d-4973-829d-537d5c86f900 68382-950 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171031 ANDA ANDA207340 Zydus Pharmaceuticals (USA) Inc. AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68382-951_e926f28c-792d-4973-829d-537d5c86f900 68382-951 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171031 ANDA ANDA207340 Zydus Pharmaceuticals (USA) Inc. AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE 1.875; 1.875; 1.875; 1.875 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68382-952_e926f28c-792d-4973-829d-537d5c86f900 68382-952 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171031 ANDA ANDA207340 Zydus Pharmaceuticals (USA) Inc. AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68382-953_e926f28c-792d-4973-829d-537d5c86f900 68382-953 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171031 ANDA ANDA207340 Zydus Pharmaceuticals (USA) Inc. AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] N 20181231 68382-954_e926f28c-792d-4973-829d-537d5c86f900 68382-954 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171031 ANDA ANDA207340 Zydus Pharmaceuticals (USA) Inc. AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE 3.75; 3.75; 3.75; 3.75 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68382-955_e926f28c-792d-4973-829d-537d5c86f900 68382-955 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171031 ANDA ANDA207340 Zydus Pharmaceuticals (USA) Inc. AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68382-956_e926f28c-792d-4973-829d-537d5c86f900 68382-956 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20171031 ANDA ANDA207340 Zydus Pharmaceuticals (USA) Inc. AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE 7.5; 7.5; 7.5; 7.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68382-989_ecf33a28-5e9e-4aa4-b837-0543070790d7 68382-989 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin INJECTION, SOLUTION INTRAVENOUS 20170801 ANDA ANDA205968 Zydus Pharmaceuticals (USA) Inc. LEVOFLOXACIN 25 mg/mL N 20181231 68382-998_600ef4f3-ad90-4cc1-a7a4-e428c0e62c3d 68382-998 HUMAN PRESCRIPTION DRUG clobetasol propionate clobetasol propionate SPRAY TOPICAL 20170712 ANDA ANDA206378 Zydus Pharmaceuticals (USA) Inc. CLOBETASOL PROPIONATE .05 g/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68387-106_b09ca9eb-a382-42fb-85bc-ef9ae7105ffb 68387-106 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20100115 ANDA ANDA076615 Keltman Pharmaceuticals Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 68387-108_654dcfdc-4012-426e-bcd3-eb21b8e3ce2a 68387-108 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20080625 ANDA ANDA040486 Keltman Pharmaceuticals Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 68387-119_6617ac19-8910-4f15-9980-80d3d8628340 68387-119 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110909 ANDA ANDA077397 Keltman Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 68387-130_8eba76b2-3510-40b2-a169-e8c1aea145e1 68387-130 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20050601 ANDA ANDA076347 Keltman Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 68387-140_8eba76b2-3510-40b2-a169-e8c1aea145e1 68387-140 HUMAN PRESCRIPTION DRUG TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE TABLET ORAL 20050601 ANDA ANDA076347 Keltman Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 68387-165_698b68f2-a474-4a72-a3b4-54bcc4a1d9bb 68387-165 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20101117 ANDA ANDA072192 Keltman Pharmaceuticals Inc. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 68387-166_698b68f2-a474-4a72-a3b4-54bcc4a1d9bb 68387-166 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20101117 ANDA ANDA072193 Keltman Pharmaceuticals Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 68387-170_3bea99e4-ca58-4fb1-b08d-f482b136a5ad 68387-170 HUMAN PRESCRIPTION DRUG Methylprednisolone methylprednisolone TABLET ORAL 20070914 NDA NDA011153 Keltman Pharmaceuticals Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68387-208_a0e7b75d-817b-4584-b5cc-8eeb31fd06f2 68387-208 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20070824 ANDA ANDA078558 Keltman Pharmaceuticals Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68387-210_a0e7b75d-817b-4584-b5cc-8eeb31fd06f2 68387-210 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20070824 ANDA ANDA078558 Keltman Pharmaceuticals Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68387-214_847dce67-5308-4ef6-acb4-e8f54959c743 68387-214 HUMAN OTC DRUG ACETAMINOPHEN Acetaminophen TABLET ORAL 20110101 OTC MONOGRAPH FINAL part343 Keltman Pharmaceuticals Inc. ACETAMINOPHEN 500 mg/1 E 20171231 68387-230_5d819e04-2719-49b2-be5c-f7967563b3fa 68387-230 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20100701 ANDA ANDA089699 Keltman Pharmaceuticals Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 68387-235_6baa87dc-cd24-4cc9-8e7d-4bf27484745a 68387-235 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20101117 ANDA ANDA040746 Keltman Pharmaceuticals Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 68387-236_566bd196-3c0c-4f05-9e2e-4803ad3126d4 68387-236 HUMAN PRESCRIPTION DRUG Norco Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20080201 ANDA ANDA040099 Keltman Pharmaceuticals Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 68387-240_8f56731f-733c-4f54-8fb3-296413c22832 68387-240 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20070423 ANDA ANDA083677 Keltman Pharmaceuticals Inc. PREDNISONE 20 mg/1 E 20171231 68387-241_8f56731f-733c-4f54-8fb3-296413c22832 68387-241 HUMAN PRESCRIPTION DRUG Prednisone PREDNISONE TABLET ORAL 20080707 ANDA ANDA083677 Keltman Pharmaceuticals Inc. PREDNISONE 10 mg/1 E 20171231 68387-250_813e328e-b953-413e-b467-33e71b9211db 68387-250 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 20090319 ANDA ANDA089805 Keltman Pharmaceuticals Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 CIII E 20171231 68387-260_4b03d85a-0a8d-40e8-b8b1-57184ec19082 68387-260 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20090701 ANDA ANDA077863 Keltman Pharmaceuticals Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68387-310_3c25b886-348e-490c-88ff-b7633a1efcb5 68387-310 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Ranitidine Hydrochloride TABLET, FILM COATED ORAL 20090701 ANDA ANDA074467 Keltman Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 68387-340_164d7dfa-e10c-4ca9-863a-1837e73b6522 68387-340 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20070725 ANDA ANDA085159 Keltman Pharmaceuticals Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 68387-342_164d7dfa-e10c-4ca9-863a-1837e73b6522 68387-342 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20090508 ANDA ANDA085159 Keltman Pharmaceuticals Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 68387-345_7e1f7076-7c07-4f46-ba25-9dd18aa47baa 68387-345 HUMAN PRESCRIPTION DRUG Indomethacin extended-release Indomethacin extended-release CAPSULE ORAL 20060109 ANDA ANDA074464 Keltman Pharmaceuticals Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68387-375_5af155d7-3780-435b-9a87-0ce01f1ed6ec 68387-375 HUMAN PRESCRIPTION DRUG Parafon DSC Chlorzoxazone TABLET ORAL 20040620 ANDA ANDA089895 Keltman Pharmaceuticals Inc. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 68387-381_b13ea7d4-6d5a-4dd1-906a-6479480453ab 68387-381 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20110110 ANDA ANDA065095 Keltman Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 68387-385_43ff2749-e5bb-4baf-8d73-7c56b7cd2eb4 68387-385 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100301 ANDA ANDA076899 Keltman Pharmaceuticals Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 68387-404_5ff43590-6bcd-4b01-8922-ed2089e9ec37 68387-404 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091215 ANDA ANDA078428 Keltman Pharmaceuticals Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 68387-410_5ff43590-6bcd-4b01-8922-ed2089e9ec37 68387-410 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091215 ANDA ANDA078428 Keltman Pharmaceuticals Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 68387-420_5ff43590-6bcd-4b01-8922-ed2089e9ec37 68387-420 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091215 ANDA ANDA078428 Keltman Pharmaceuticals Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 68387-440_2f99c62e-06ed-4e9b-8e53-18d9a85e1e7d 68387-440 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20100420 ANDA ANDA074754 Keltman Pharmaceuticals Inc. KETOROLAC TROMETHAMINE 10 mg/1 E 20171231 68387-450_36c67b60-9529-4f19-a4b8-b68788f836c1 68387-450 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 20070310 ANDA ANDA018578 Keltman Pharmaceuticals Inc. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 68387-456_9c160477-60c6-4f71-9269-48432b6799f1 68387-456 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20110127 NDA NDA022122 Keltman Pharmaceuticals Inc. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68387-491_b3fe37b1-8adc-4728-a7c7-9fec050b21ec 68387-491 HUMAN PRESCRIPTION DRUG SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM SOLUTION OPHTHALMIC 20100110 ANDA ANDA089560 Keltman Pharmaceuticals Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 68387-497_daef6ebf-66a8-4909-90e1-20d39ed5ed20 68387-497 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen tramadol hydrochloride and acetaminophen TABLET ORAL 20091019 ANDA ANDA076475 Keltman Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 68387-500_a29e48fd-183b-49af-ba71-7eec24bcd115 68387-500 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20060824 ANDA ANDA071611 Keltman Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 68387-502_a29e48fd-183b-49af-ba71-7eec24bcd115 68387-502 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20100610 ANDA ANDA071611 Keltman Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 68387-521_986cbe30-d77a-4ab9-95ba-891b453e6309 68387-521 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20101210 ANDA ANDA076063 Keltman Pharmaceuticals Inc. LISINOPRIL 20 mg/1 E 20171231 68387-531_49cd8e11-2282-4c5b-bb4f-95526a9e2d6b 68387-531 HUMAN PRESCRIPTION DRUG Pentazocine and naloxone PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET ORAL 20090721 ANDA ANDA074736 Keltman Pharmaceuticals Inc. PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 50; .5 mg/1; mg/1 Competitive Opioid Antagonists [MoA],Partial Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] E 20171231 68387-545_f3d225b4-4057-4b9d-b560-d8d3357f9561 68387-545 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20101210 ANDA ANDA078432 Keltman Pharmaceuticals Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68387-550_dacd7084-7ed1-4371-91ea-c797f4636afa 68387-550 HUMAN PRESCRIPTION DRUG Mupirocin mupirocin OINTMENT TOPICAL 20090622 ANDA ANDA065192 Keltman Pharmaceuticals Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] E 20171231 68387-552_8988f2ff-e9e5-47c4-816b-0fc28a599780 68387-552 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 20060301 NDA NDA020998 Keltman Pharmaceuticals Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68387-558_f66fe0dd-f036-43c8-8527-c1384dbd6791 68387-558 HUMAN PRESCRIPTION DRUG Topiramate TOPIRAMATE TABLET ORAL 20100730 ANDA ANDA079162 Keltman Pharmaceuticals Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68387-559_f66fe0dd-f036-43c8-8527-c1384dbd6791 68387-559 HUMAN PRESCRIPTION DRUG Topiramate TOPIRAMATE TABLET ORAL 20100730 ANDA ANDA079162 Keltman Pharmaceuticals Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68387-560_f66fe0dd-f036-43c8-8527-c1384dbd6791 68387-560 HUMAN PRESCRIPTION DRUG Topiramate TOPIRAMATE TABLET ORAL 20100730 ANDA ANDA079162 Keltman Pharmaceuticals Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68387-600_ec7bacfe-34c8-48a0-b064-fc9367b81150 68387-600 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070810 ANDA ANDA040124 Keltman Pharmaceuticals Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 68387-690_1df7b178-a093-4436-81da-a213d1b7cdcd 68387-690 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20070731 ANDA ANDA040527 Keltman Pharmaceuticals Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 68387-695_0a14fdc5-2428-46bf-b6d0-88bac7f9158e 68387-695 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Immediate-Release Diethylpropion hydrochloride TABLET ORAL 20100607 ANDA ANDA011722 Keltman Pharmaceuticals Inc. DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 68387-696_0a14fdc5-2428-46bf-b6d0-88bac7f9158e 68387-696 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 20100607 ANDA ANDA011722 Keltman Pharmaceuticals Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 68387-700_9d3e528b-a748-4bc5-b604-e7e9c5ab9183 68387-700 HUMAN PRESCRIPTION DRUG Feldene Piroxicam CAPSULE ORAL 20070918 ANDA ANDA074131 Keltman Pharmaceuticals Inc. PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68387-800_e242ccf8-7339-4a43-82ff-a7b0a6384799 68387-800 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090427 ANDA ANDA075927 Keltman Pharmaceuticals Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68387-801_e242ccf8-7339-4a43-82ff-a7b0a6384799 68387-801 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20090427 ANDA ANDA075927 Keltman Pharmaceuticals Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68387-802_e242ccf8-7339-4a43-82ff-a7b0a6384799 68387-802 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20101004 ANDA ANDA075927 Keltman Pharmaceuticals Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68387-900_d24bc5c8-18dc-40a6-b54f-7d4e20175950 68387-900 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20090630 ANDA ANDA076003 Keltman Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 68391-001_a8263eab-358a-4b25-9d16-a3ddbac19600 68391-001 HUMAN OTC DRUG berkley and jensen tussin cough and chest congestion dm Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20150217 OTC MONOGRAPH FINAL part341 BJWC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 68391-004_01a576b4-e359-45f9-bbc0-a20a039f5097 68391-004 HUMAN OTC DRUG Berley and Jensen Pain Relief Acetaminophen TABLET, FILM COATED ORAL 20151130 OTC MONOGRAPH NOT FINAL part343 BJWC ACETAMINOPHEN 500 mg/1 N 20181231 68391-012_cdaa2643-7630-41e8-bd48-4a760cf4a46a 68391-012 HUMAN OTC DRUG Berkley and Jensen NICOTINE Nicotine polacrilex GUM, CHEWING ORAL 20170228 ANDA ANDA206394 BJWC NICOTINE 2 mg/1 N 20181231 68391-029_62938255-c604-4139-a22f-b57179f27ff7 68391-029 HUMAN OTC DRUG berkley and jensen nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20060119 ANDA ANDA076775 BJWC NICOTINE 2 mg/1 N 20181231 68391-050_3182dbb1-6656-4988-ba0f-7a60af45ee8b 68391-050 HUMAN OTC DRUG berkley and jensen ibuprofen pm diphenhydramine citrate, ibuprofen TABLET, COATED ORAL 20090427 ANDA ANDA079113 BJWC DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 68391-100_21340a4d-270f-4ab6-8b80-5a9434539b65 68391-100 HUMAN OTC DRUG berkley and jensen anti itch Hydrocortisone CREAM TOPICAL 20141209 OTC MONOGRAPH NOT FINAL part348 BJWC HYDROCORTISONE 1 g/100g N 20181231 68391-105_9b610d89-9395-428a-b2cd-5476ee7d94f5 68391-105 HUMAN OTC DRUG Berkley Jensen Foaming Hand with Green Tea and Aloe Benzalkonium Chloride LIQUID TOPICAL 20170120 OTC MONOGRAPH NOT FINAL part333E BJWC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 68391-110_9a461566-91d5-404b-9875-7d0b04767e11 68391-110 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE ORAL 20130610 OTC MONOGRAPH NOT FINAL part334 BJWC (Berkley & Jensen / BJ's) DOCUSATE SODIUM 100 mg/1 N 20181231 68391-117_764bc6a9-b84d-4998-b25a-09f8fe8cc578 68391-117 HUMAN OTC DRUG Berkley and Jensen Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120522 ANDA ANDA202319 BJWC LANSOPRAZOLE 15 mg/1 N 20181231 68391-121_fac5e42a-8d01-4f85-ac6c-cca9a768f5d7 68391-121 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20120901 ANDA ANDA202300 BJWC IBUPROFEN 200 mg/1 N 20181231 68391-131_d5e9900e-353b-40e8-982a-cca4504ed18c 68391-131 HUMAN OTC DRUG Berkley and Jensen Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20170303 ANDA ANDA203599 BJWC IBUPROFEN 200 mg/1 N 20181231 68391-133_89d0d75e-219b-41de-a4e6-d7aa7e2f8424 68391-133 HUMAN OTC DRUG Berkley and Jensen Allergy Relief Fluticasone propionate SPRAY, METERED NASAL 20160627 ANDA ANDA207957 BJWC FLUTICASONE PROPIONATE 50 ug/1 N 20191231 68391-141_46451256-08fe-4e9e-a0c9-f486368c62c5 68391-141 HUMAN OTC DRUG ANTIBACTERIAL WITH LIGHT MOISTURIZERS TRICLOSAN SOAP TOPICAL 20100723 OTC MONOGRAPH NOT FINAL part333E BJWC TRICLOSAN .115 mL/100mL N 20181231 68391-149_6111ec2c-0586-4fea-bb17-e510f4c4a17b 68391-149 HUMAN OTC DRUG BERKELEY AND JENSEN ANTIBACTERIAL BENZALKONIUM CHLORIDE LIQUID TOPICAL 20140409 OTC MONOGRAPH NOT FINAL part333E BJWC BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 68391-150_fc6359ec-d9c4-4111-9234-9e1c26497ca2 68391-150 HUMAN OTC DRUG BERKLEY JENSEN ANTIBACTERIAL HAND BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141209 OTC MONOGRAPH NOT FINAL part333E BJWC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 68391-161_1c3f6436-ad11-4d98-a8b9-f28ac99c5bfb 68391-161 HUMAN OTC DRUG Acetaminophen PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130115 OTC MONOGRAPH NOT FINAL part343 BJWC (Berkley & Jensen / BJ's) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 68391-167_6969bdb6-7dd0-4a54-af1c-7b9de38c5515 68391-167 HUMAN OTC DRUG Berkley Jensen Instant Sanitizer Ethyl Alcohol LIQUID TOPICAL 20170527 OTC MONOGRAPH NOT FINAL part333E BJWC ALCOHOL 650 mg/mL N 20181231 68391-167_a026b5c9-d9e2-4b7d-86bc-f36a0c1ed36f 68391-167 HUMAN OTC DRUG BERKLEY JENSEN INSTANT SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20150113 OTC MONOGRAPH NOT FINAL part333E BJWC ALCOHOL 650 mg/mL N 20181231 68391-170_93d92426-f146-42e3-a27e-0e3c2f872ce5 68391-170 HUMAN OTC DRUG berkley and jensen nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20060118 ANDA ANDA076789 BJWC NICOTINE 4 mg/1 N 20181231 68391-199_0d96cc5c-e262-4866-a3cc-31c565d93dca 68391-199 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20130515 ANDA ANDA078682 BJWC (Berkley & Jensen / BJ's) IBUPROFEN 200 mg/1 N 20181231 68391-200_65cb22a3-5487-40c4-a3b6-b1d9dad7769a 68391-200 HUMAN OTC DRUG Berkley and Jensen Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20131210 OTC MONOGRAPH FINAL part341 BJWC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68391-207_c1959ab6-a362-40f2-8a6d-bb697784075c 68391-207 HUMAN OTC DRUG berkley and jensen triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20141030 OTC MONOGRAPH FINAL part333B BJWC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 68391-213_fc45ddfa-04c1-4973-a616-9ea496605849 68391-213 HUMAN OTC DRUG Non Aspirin PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130430 OTC MONOGRAPH FINAL part341 BJWC (Berkley & Jensen / BJ's) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 68391-224_a4fe82ca-c90f-4fdb-8262-b4ea871ac901 68391-224 HUMAN OTC DRUG berkley and jensen anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030419 ANDA ANDA075232 BJWC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20191231 68391-227_018c1f57-224e-420b-bc2e-73a68559f5ab 68391-227 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130331 OTC MONOGRAPH FINAL part343 BJWC (Berkley & Jensen / BJ's) ASPIRIN 81 mg/1 N 20181231 68391-238_ab82f447-555d-4359-8d2a-0f8a889d7658 68391-238 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20130708 OTC MONOGRAPH NOT FINAL part334 BJWC (Berkley & Jensen / BJ's) DOCUSATE SODIUM 100 mg/1 N 20181231 68391-242_4c0d3b89-d8e2-466f-a1f7-f411cb5b87bc 68391-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH FINAL part347 BJWC (Berkley & Jensen / BJ's) DIMETHICONE 125 mg/1 N 20181231 68391-267_0e951192-7f44-4d00-81d4-62e4d53eb2c2 68391-267 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110106 OTC MONOGRAPH NOT FINAL part333E BJWC ALCOHOL 65 mL/100mL N 20181231 68391-267_7fae4a5c-b4f9-4d87-b68a-d3cd323b0d72 68391-267 HUMAN OTC DRUG INSTANT HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20110106 OTC MONOGRAPH NOT FINAL part333E BJWC ALCOHOL 65 mL/100mL N 20181231 68391-300_853eda83-bb50-42ee-a678-94740e26142a 68391-300 HUMAN OTC DRUG berkley and jensen famotidine Famotidine TABLET ORAL 20131209 ANDA ANDA077351 BJWC FAMOTIDINE 20 mg/1 N 20181231 68391-306_e6163454-4109-4fc1-9bd5-22cfe78c46a5 68391-306 HUMAN OTC DRUG berkley and jensen clearlax Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20091217 ANDA ANDA090685 BJWC POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 68391-309_b04f4f1e-55d3-4486-acf1-6a93dc919f2d 68391-309 HUMAN OTC DRUG Berkley and Jensen Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170228 ANDA ANDA206393 BJWC NICOTINE 4 mg/1 N 20181231 68391-314_e0ff7c35-dd81-4e90-a1bc-a16e4e233904 68391-314 HUMAN OTC DRUG Berkley and Jensen Allergy Relief Loratadine TABLET ORAL 20090417 ANDA ANDA076301 BJWC LORATADINE 10 mg/1 N 20181231 68391-344_857cf1ac-8862-44a6-b145-a03cce37cf13 68391-344 HUMAN OTC DRUG berkley and jensen nicotine Nicotine Polacrilex LOZENGE ORAL 20060502 ANDA ANDA077007 BJWC NICOTINE 2 mg/1 N 20181231 68391-368_8d74f0aa-36c3-4542-9dd6-fdcdc92718d1 68391-368 HUMAN OTC DRUG Berkley and Jensen Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20070917 ANDA ANDA074661 BJWC NAPROXEN SODIUM 220 mg/1 N 20181231 68391-416_d08ec2c1-b841-47ac-85a5-198ec41d7a68 68391-416 HUMAN OTC DRUG Berkley and Jensen Aspirin Aspirin TABLET ORAL 20080723 OTC MONOGRAPH NOT FINAL part343 BJWC ASPIRIN 325 mg/1 N 20181231 68391-447_c66b1ef3-b4e4-4b9b-86ff-834fcd58ff63 68391-447 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20141231 OTC MONOGRAPH FINAL part341 BJWC (Berkley & Jensen / BJ's) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 68391-456_571168b0-672d-44be-b76c-3607e46d42c4 68391-456 HUMAN OTC DRUG berkley and jensen nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070531 ANDA ANDA076777 BJWC NICOTINE 2 mg/1 N 20181231 68391-472_13385149-54f2-4681-a4e8-8ae212458778 68391-472 HUMAN OTC DRUG Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20160331 OTC MONOGRAPH FINAL part341 BJWC (Berkley & Jensen / BJ's) N 20191231 68391-484_21d0e427-2370-4c29-a2fe-c8ff6aea7971 68391-484 HUMAN OTC DRUG berkley and jensen pain relief extra strength Acetaminophen TABLET ORAL 20060918 OTC MONOGRAPH NOT FINAL part343 BJWC ACETAMINOPHEN 500 mg/1 N 20181231 68391-490_4656a257-c0aa-4f63-af8e-e52a56478557 68391-490 HUMAN OTC DRUG Daytime Nighttime Cold/Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20130115 OTC MONOGRAPH FINAL part341 BJWC (Berkley & Jensen / BJ's) N 20181231 68391-500_95143ed7-b6a2-4557-8fce-c815ffbd07d3 68391-500 HUMAN OTC DRUG Berkley and Jensen Allergy Relief Cetirizine Hydrochloride TABLET ORAL 20131126 ANDA ANDA078336 BJWC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 68391-517_734f247e-231e-45e3-97aa-5def0ec36b51 68391-517 HUMAN OTC DRUG berkley and jensen ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20090115 ANDA ANDA077349 BJWC IBUPROFEN 200 mg/1 N 20181231 68391-532_0ea8745b-77c6-4dae-a64b-25187d7bbc05 68391-532 HUMAN OTC DRUG berkley and jensen nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20070531 ANDA ANDA076779 BJWC NICOTINE 4 mg/1 N 20181231 68391-536_084219c6-b1fc-49e2-bbcd-a9e0881819f4 68391-536 HUMAN OTC DRUG berkley and jensen migraine formula Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20140221 ANDA ANDA075794 BJWC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 68391-550_ad83cde8-345a-4e36-8c32-e25b56f5631d 68391-550 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130715 OTC MONOGRAPH FINAL part332 BJWC (Berkley & Jensen / BJ's) DIMETHICONE 125 mg/1 N 20181231 68391-571_a49fe240-5b5f-48ae-a56d-7517b590fab6 68391-571 HUMAN OTC DRUG Berkley and Jensen Allergy Relief fexofenadine hcl TABLET, FILM COATED ORAL 20110811 ANDA ANDA076447 BJWC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 68391-604_30d82cfc-3d2d-4080-acc8-3ca486b4a546 68391-604 HUMAN OTC DRUG Berkley and Jensen Ibuprofen Ibuprofen TABLET ORAL 20070620 ANDA ANDA072096 BJWC IBUPROFEN 200 mg/1 N 20181231 68391-669_04ad3a6c-9a2b-4b76-9bde-be07563ef33a 68391-669 HUMAN OTC DRUG Berkley and Jensen Arthritis Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140508 ANDA ANDA075077 BJWC ACETAMINOPHEN 650 mg/1 N 20181231 68391-685_49e41b86-50b1-4cb5-bfef-9b06ba93c9ab 68391-685 HUMAN OTC DRUG Berkley and Jensen ibuprofen childrens dye free Ibuprofen SUSPENSION ORAL 20100107 ANDA ANDA074937 BJWC IBUPROFEN 100 mg/5mL N 20181231 68391-734_1055f032-3a6e-40d3-8343-d144953c143d 68391-734 HUMAN OTC DRUG berkley and jensen nicotine Nicotine Polacrilex LOZENGE ORAL 20171106 ANDA ANDA203690 BJWC NICOTINE 2 mg/1 N 20181231 68391-799_9f3a5835-6e6f-4e6b-8419-ba3ecb109439 68391-799 HUMAN OTC DRUG Berkley Jensen Tussin Dextromethorphan HBr, Guaifenesin SUSPENSION ORAL 20160718 OTC MONOGRAPH FINAL part341 BJWC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 68391-837_28544e6d-391d-4453-93fc-2a66a0a3b1e8 68391-837 HUMAN OTC DRUG Berkley and Jensen Ranitidine Ranitidine TABLET, FILM COATED ORAL 20140701 ANDA ANDA091429 BJWC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 68391-852_2aa1cc94-35b2-436d-831b-de6a07ebb46b 68391-852 HUMAN OTC DRUG Berkley and Jensen Ranitidine Ranitidine TABLET, FILM COATED ORAL 20160901 ANDA ANDA091429 BJWC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 68391-873_1bed10ac-1a5d-47cb-9133-d47dbae120ca 68391-873 HUMAN OTC DRUG berkley and jensen nicotine polacrilex Nicotine Polacrilex LOZENGE ORAL 20060502 ANDA ANDA077007 BJWC NICOTINE 4 mg/1 N 20181231 68391-897_e5692faf-7168-476a-9511-5cdc1f841893 68391-897 HUMAN OTC DRUG Berkley and Jensen Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20160825 ANDA ANDA074937 BJWC IBUPROFEN 100 mg/5mL N 20191231 68391-898_2369c948-d46f-4ace-bc51-47477631bc43 68391-898 HUMAN OTC DRUG berkley and jensen heartburn treatment Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170925 ANDA ANDA207193 BJWC ESOMEPRAZOLE 20 mg/1 N 20181231 68391-915_16b22564-9d65-4fcf-82d1-364cf0834013 68391-915 HUMAN OTC DRUG Berkley and Jensen Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20080228 NDA NDA022032 BJWC OMEPRAZOLE 20 mg/1 N 20181231 68391-957_357123fc-0972-4683-ab52-f95d46c1b6c9 68391-957 HUMAN OTC DRUG berkley and jensen nicotine Nicotine Polacrilex LOZENGE ORAL 20171106 ANDA ANDA203690 BJWC NICOTINE 4 mg/1 N 20181231 68400-105_de4e5c8f-8ade-4126-b860-ff95967635c3 68400-105 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-106_8cb563ba-ac0d-416f-8e08-78b352804223 68400-106 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-107_0c7cb791-d466-4d2c-a980-2d21c39c2d84 68400-107 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-108_e581780e-4eb3-4b0d-b11c-45b18695ed4b 68400-108 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-109_ec5eb067-a97e-4393-9f15-f20dc91e5222 68400-109 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-110_6ade8436-f59c-4659-977a-e4a92f845ab9 68400-110 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-111_34a650b4-dfcd-42dc-877f-e9c31d2e0717 68400-111 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-114_d8a522e4-b8f6-4565-aa29-64bdd758d715 68400-114 HUMAN PRESCRIPTION DRUG Gelato Neutral pH Sodium Fluoride GEL DENTAL 20130301 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 4.086 g/454g N 20181231 68400-115_e45830a8-7f1f-486e-b8bd-cf182bec40e9 68400-115 HUMAN PRESCRIPTION DRUG Gelato Neutral pH Sodium Fluoride GEL DENTAL 20130301 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 4.086 g/454g N 20181231 68400-120_2735335f-a21e-4232-bf80-379239a05fdc 68400-120 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-121_e24d64a9-b8e2-4e14-84fe-afb7226a0509 68400-121 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-122_9b9a7652-688e-43df-9230-ce2e2b72c416 68400-122 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-135_9149c49e-0bfa-4fc7-9a08-6613f0309269 68400-135 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-136_d4152902-30a1-4385-aac5-00d3020d3264 68400-136 HUMAN PRESCRIPTION DRUG Gelato Neutral pH Sodium Fluoride GEL DENTAL 20130301 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc SODIUM FLUORIDE 4.086 g/454g N 20181231 68400-138_202c46b4-9136-4bce-8cee-82718ebb3818 68400-138 HUMAN PRESCRIPTION DRUG Gelato Neutral PH Sodium Fluoride AEROSOL, FOAM DENTAL; ORAL; TOPICAL 20110811 UNAPPROVED DRUG OTHER Deepak Products, inc. SODIUM FLUORIDE 2.5 g/125g N 20181231 68400-201_6b12195a-7145-4acb-b0f4-48bb4a071904 68400-201 HUMAN OTC DRUG Gelato Homecare Stannous Fluoride GEL DENTAL 20130105 OTC MONOGRAPH FINAL part355 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. STANNOUS FLUORIDE .116 g/120g N 20181231 68400-202_61a36062-e3c3-4aa2-8c0d-368166090b7d 68400-202 HUMAN PRESCRIPTION DRUG Gelato Perio Maintenance Rinse Stannous Fluoride CONCENTRATE DENTAL 20130201 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. STANNOUS FLUORIDE .34 g/283.5g N 20181231 68400-203_eb73af5b-9851-446a-a4d0-1e731d6cfd95 68400-203 HUMAN PRESCRIPTION DRUG Hemox A Aluminum Chloride SOLUTION DENTAL 20130115 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. ALUMINUM CHLORIDE 7500 mg/30mL N 20181231 68400-205_f323d024-6401-4201-8bcd-69dbf2bbb225 68400-205 HUMAN OTC DRUG Gelato Homecare Stannous Fluoride GEL DENTAL 20130105 OTC MONOGRAPH FINAL part355 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. STANNOUS FLUORIDE .116 g/120g N 20181231 68400-206_4cc89690-63df-4790-9e96-8398b9104211 68400-206 HUMAN PRESCRIPTION DRUG Gelato Perio Maintenance Rinse Stannous Fluoride CONCENTRATE DENTAL 20130201 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. STANNOUS FLUORIDE .34 g/283.5g N 20181231 68400-207_8b5eca4f-58d1-4904-9f88-f5eeafa2664e 68400-207 HUMAN PRESCRIPTION DRUG Gelato Homecare Vivid Neutral Sodium Fluoride GEL DENTAL 20130315 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE .597 g/120g N 20181231 68400-208_db210473-199e-47a5-89ac-187e01d68299 68400-208 HUMAN PRESCRIPTION DRUG Gelato Homecare Vivid Neutral Sodium Fluoride GEL DENTAL 20130315 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE .597 g/120g N 20181231 68400-313_fc8d6880-5be0-4e95-9491-43e7b2163e8c 68400-313 HUMAN PRESCRIPTION DRUG Gelato APF Sodium Fluoride GEL DENTAL 20140401 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-323_7e4f5c51-1523-46f3-ba4d-78353ca1c6e7 68400-323 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine SPRAY, METERED DENTAL 20130729 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 11.4 g/57g N 20181231 68400-350_62b32609-7488-4cf5-a1bf-19d6026e3ade 68400-350 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-351_cbd4b1aa-5313-44b4-93d7-b6dc18347b9f 68400-351 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-352_f95b379f-2534-4cc2-a033-b3ef71d76dac 68400-352 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-353_46c55f99-cfbc-4beb-91b8-ce388d975394 68400-353 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-354_0d7b9d84-e9f9-4f8e-b12f-852e215d194a 68400-354 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-355_5513f5ee-6f10-4302-9877-fca1fb86f975 68400-355 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-356_2038daf6-078c-4fc1-abca-c8a07c804ad8 68400-356 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-357_5c508e07-c4c8-4028-83a2-44b50e806db8 68400-357 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-358_1af98d3c-c4e4-4e8a-b7f9-af187ae6e49e 68400-358 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-359_40feaba5-8f7a-45fc-87bb-2b16aad8d527 68400-359 HUMAN OTC DRUG Gelato Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-700_c5a808a5-a566-4636-9d9e-f37c6473f16f 68400-700 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-701_d9ca94fc-bed3-481c-9bd6-945fae0f3803 68400-701 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-702_6a67a7a9-a1d1-41c2-a283-cc5d328a931e 68400-702 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-703_d851761a-4183-4359-bc63-bceb0ac7f06c 68400-703 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-704_eebc32c7-db13-4370-8625-99a081f73e3a 68400-704 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-705_5921f8b2-d908-404b-8554-ff29b01b43b0 68400-705 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-706_d409ad68-a47e-4224-88cd-880a91cf3841 68400-706 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-707_6b35e9f7-e488-4a06-b167-bc09d8abf265 68400-707 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-708_d811efe2-3964-4f7d-8304-84e10601fe61 68400-708 HUMAN PRESCRIPTION DRUG Sorbet APF Sodium Fluoride GEL DENTAL 20121214 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 68400-800_2d56c92c-cae2-48d6-8cbd-ac2bada8b1aa 68400-800 HUMAN OTC DRUG Sorbet Homecare Stannous Fluoride GEL DENTAL 20130105 OTC MONOGRAPH FINAL part355 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. STANNOUS FLUORIDE .116 g/120g N 20181231 68400-850_cd13222e-0232-49b2-8119-1620949048c1 68400-850 HUMAN PRESCRIPTION DRUG Sorbet Neutral Sodium Fluoride GEL DENTAL 20130315 UNAPPROVED DRUG OTHER Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. SODIUM FLUORIDE .597 g/120g N 20181231 68400-994_603ef657-b34f-633f-e053-2a91aa0a847f 68400-994 HUMAN OTC DRUG Comfortcaine Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepack Products Inc. BENZOCAINE 200 mg/g N 20181231 68400-995_60629d6b-774b-c216-e053-2a91aa0a2bb9 68400-995 HUMAN OTC DRUG ComfortCaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-996_60627de8-e6c6-9713-e053-2a91aa0a9ac2 68400-996 HUMAN OTC DRUG ComfortCaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-997_60629937-253f-14df-e053-2991aa0aa343 68400-997 HUMAN OTC DRUG ComfortCaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-998_60629937-2551-14df-e053-2991aa0aa343 68400-998 HUMAN OTC DRUG ComfortCaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68400-999_5fafa2fc-020f-2ad1-e053-2a91aa0ac60e 68400-999 HUMAN OTC DRUG ComfortCaine Topical Anesthetic Benzocaine GEL DENTAL 19970101 OTC MONOGRAPH NOT FINAL part356 Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc BENZOCAINE 200 mg/g N 20181231 68403-1100_9137e6f2-aef9-407a-8e55-326b67e27b65 68403-1100 HUMAN PRESCRIPTION DRUG BabyBIG human botulinum neurotoxin a/b immune globulin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20031023 BLA BLA125034 CALIFORNIA DEPARTMENT OF PUBLIC HEALTH HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN 50 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Bacterial Neurotoxin Neutralization [MoA],Antitoxins [Chemical/Ingredient] N 20181231 68405-070_be204725-f483-4bf0-a87a-7b5cd55953a3 68405-070 HUMAN PRESCRIPTION DRUG Lytensopril LISINOPRIL, ARGININE KIT 20110707 UNAPPROVED DRUG OTHER Physician Therapeutics LLC E 20171231 68411-4057_ac196ff8-98ae-4e74-a33f-a4fabdd56ca7 68411-4057 HUMAN OTC DRUG Minus-Sol Facial Sun Protection Sunscreen Broad Spectrum SPF 30 Plus White OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120322 OTC MONOGRAPH NOT FINAL part352 Aledian Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 2; 5 g/100g; g/100g; g/100g E 20171231 68411-4058_3367a078-fe41-4de6-9310-35dc25d24e70 68411-4058 HUMAN OTC DRUG Minus-Sol Facial Sun Protection Sunscreen Broad Spectrum SPF 30 Plus Ivory OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120322 OTC MONOGRAPH NOT FINAL part352 Aledian Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 4; 5; 5 g/100g; g/100g; g/100g E 20171231 68419-0001_e5b529a2-46bf-4856-867d-6292b6406c0b 68419-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20031001 UNAPPROVED MEDICAL GAS American Medical Gas LLC OXYGEN 99 L/100L E 20171231 68421-5100_d4eb7f67-0a7d-4c09-adda-190cdb2b6749 68421-5100 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SPRAY TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Cintas First Aid & Safety LIDOCAINE HYDROCHLORIDE 20 g/L N 20181231 68421-5100_e5cabec2-8b68-4f0a-b21f-f59d63e8ab88 68421-5100 HUMAN OTC DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SPRAY TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part348 Cintas First Aid & Safety LIDOCAINE HYDROCHLORIDE 20 g/L N 20181231 68421-5400_64a235b9-fcb1-48ca-a16e-fb094a0a5dab 68421-5400 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part333A Cintas First Aid & Safety HYDROGEN PEROXIDE 43.275 g/L N 20181231 68421-5400_aca0cbf4-7fb8-4dff-89d2-5acdf3bebe6a 68421-5400 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part333A Cintas First Aid & Safety HYDROGEN PEROXIDE 43.275 g/L N 20181231 68421-5500_216f2ae7-c16e-42b9-9688-61347feebc93 68421-5500 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part333A Cintas First Aid & Safety ISOPROPYL ALCOHOL 550.2 g/L N 20181231 68421-5500_57a04181-6cff-4425-a2d7-d82c8f5758df 68421-5500 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20130418 OTC MONOGRAPH NOT FINAL part333A Cintas First Aid & Safety ISOPROPYL ALCOHOL 550.2 g/L N 20181231 68421-6500_c514a8d6-f62a-4acb-ad42-2df85edb3b7c 68421-6500 HUMAN OTC DRUG First Aid Triple Antibiotic with Pain Reliever bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine OINTMENT TOPICAL 20070330 OTC MONOGRAPH FINAL part333B Cintas First Aid & Safety BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; LIDOCAINE 400; 3.5; 5000; 40 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 68421-7120_8366774a-a3a7-48c5-85c2-b5d6410f7fdb 68421-7120 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part333E Cintas First Aid & Safety BENZALKONIUM CHLORIDE 1.2478 g/L N 20181231 68421-7120_fdb19307-485b-492d-b69f-d787b76bb4c7 68421-7120 HUMAN OTC DRUG Antiseptic benzalkonium chloride LIQUID TOPICAL 20130502 OTC MONOGRAPH NOT FINAL part333E Cintas First Aid & Safety BENZALKONIUM CHLORIDE 1.2478 g/L N 20181231 68421-8100_d33a6568-11e9-426b-8eb0-0cfd44ede2ff 68421-8100 HUMAN OTC DRUG Dental Relief benzocaine LIQUID TOPICAL 20160506 OTC MONOGRAPH NOT FINAL part356 Cintas First Aid & Safety BENZOCAINE 200 mg/g N 20181231 68421-8300_35236268-4230-42ca-8489-8b6d1c1eb448 68421-8300 HUMAN OTC DRUG Itch Relief diphenhydramine hydrochloride LIQUID TOPICAL 20130513 OTC MONOGRAPH NOT FINAL part348 Cintas First Aid & Safety DIPHENHYDRAMINE HYDROCHLORIDE 20.3 g/L N 20181231 68421-8300_74a3bcb2-d0fb-440e-a82e-e55c4827744d 68421-8300 HUMAN OTC DRUG Itch Relief diphenhydramine hydrochloride LIQUID TOPICAL 20130513 OTC MONOGRAPH NOT FINAL part348 Cintas First Aid & Safety DIPHENHYDRAMINE HYDROCHLORIDE 20.3 g/L N 20181231 68428-000_18305b39-3823-438f-9b32-293139e16449 68428-000 HUMAN OTC DRUG Abelmoschus ABELMOSCHUS MOSCHATUS SEED LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ABELMOSCHUS MOSCHATUS SEED 30 [hp_C]/mL N 20181231 68428-001_aa71c7fe-38d8-49f1-abb9-3054a8339138 68428-001 HUMAN OTC DRUG Spongatos ACONITUM NAPELLUS - IPECAC - CALCIUM SULFIDE - SPONGIA OFFICINALIS LIQUID ORAL 20100407 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS; IPECAC; CALCIUM SULFIDE; SPONGIA OFFICINALIS SKELETON, ROASTED 3; 4; 12; 3 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL N 20181231 68428-002_20cb31bf-7275-4b77-bf64-4967c272af4f 68428-002 HUMAN OTC DRUG Diarrhea ARSENIC TRIOXIDE - CUPRIC ARSENITE - VERATRUM ALBUM ROOT PELLET ORAL 20100812 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIOXIDE; CUPRIC ARSENITE; VERATRUM ALBUM ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-003_8c729b8e-8639-4395-9a14-73e57f17ad19 68428-003 HUMAN OTC DRUG Sinus CALCIUM CARBONATE - GOLDENSEAL - POTASSIUM DICHROMATE PELLET ORAL 20100512 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products OYSTER SHELL CALCIUM CARBONATE, CRUDE; GOLDENSEAL; POTASSIUM DICHROMATE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-004_9f90be2f-2540-4f8f-973f-9fbce8d0d59c 68428-004 HUMAN OTC DRUG Stomach Disorders SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL PELLET ORAL 20100713 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SOLANUM DULCAMARA TOP; ACTIVATED CHARCOAL; CHELONE GLABRA; GOLDENSEAL 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-005_415b9d17-9e81-4e78-bb3e-93ac67e46112 68428-005 HUMAN OTC DRUG Teething TRIBASIC CALCIUM PHOSPHATE - MATRICARIA RECUTITA - ARABICA COFFEE BEAN PELLET ORAL 20100824 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; ARABICA COFFEE BEAN 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-006_f05d7090-1798-40c6-8f5a-ac0e42864195 68428-006 HUMAN OTC DRUG Dry Eyes PULSATILLA VULGARIS - SILICON DIOXIDE - SULFUR PELLET ORAL 20100820 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PULSATILLA VULGARIS; SILICON DIOXIDE; SULFUR 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-007_1765e188-bd3c-43d8-9c43-d40f6516bf69 68428-007 HUMAN OTC DRUG Flatulence FERULA ASSA-FOETIDA RESIN - STRYCHNOS IGNATII SEED - NUTMEG PELLET ORAL 20100713 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERULA ASSA-FOETIDA RESIN; STRYCHNOS IGNATII SEED; NUTMEG 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-008_ebe32f39-0c5f-4e4b-90c7-5a93926708cd 68428-008 HUMAN OTC DRUG Flu-like Symptoms ARSENIC TRIIODIDE - EUPATORIUM PERFOLIATUM FLOWERING TOP - GELSEMIUM SEMPERVIRENS ROOT PELLET ORAL 20100623 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIIODIDE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-009_1bba8f0a-c74d-4861-b9ff-e72e2a5a65be 68428-009 HUMAN OTC DRUG Fungus GRAPHITE - SEPIA OFFICINALIS JUICE - SULFUR - THUJA OCCIDENTALIS LEAFY TWIG PELLET ORAL 20100707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GRAPHITE; SEPIA OFFICINALIS JUICE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-010_c9a964da-d699-4c0c-9f05-04285cebefd6 68428-010 HUMAN OTC DRUG Constipation CAPSICUM - GOLDENSEAL - VERONICASTRUM VIRGINICUM ROOT - STRYCHNOS NUX-VOMICA SEED - PODOPHYLLUM RESIN PELLET ORAL 20100707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAPSICUM; GOLDENSEAL; VERONICASTRUM VIRGINICUM ROOT; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM RESIN 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-011_b83d5093-9926-4dcd-a165-30e4f8feeb11 68428-011 HUMAN OTC DRUG Hay Fever ONION - ANTHOXANTHUM ODORATUM - SCHOENOCAULON OFFICINALE SEED PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ONION; ANTHOXANTHUM ODORATUM; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-012_2e02dfca-ac0d-4330-9376-d15820b46d04 68428-012 HUMAN OTC DRUG Headache Congested CALCIUM FLUORIDE - FERRUM PHOSPHORICUM - SODIUM PHOSPHATE, DIBASIC ANHYDROUS - SODIUM CHLORIDE PELLET ORAL 20100504 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM CHLORIDE 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-013_3b1c3805-6e3f-4987-abb3-5e767d87b9bc 68428-013 HUMAN OTC DRUG Minor Arthritic Pain APIS MELLIFERA - BLACK COHOSH - CALCIUM FLUORIDE - SODIUM PHOSPHATE, DIBASIC ANHYDROUS - SODIUM CHLORIDE - TOXICODENDRON PUBESCENS LEAF PELLET ORAL 20100707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products APIS MELLIFERA; BLACK COHOSH; CALCIUM FLUORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-014_5f26d368-8835-4b69-bcbb-ba44311fa733 68428-014 HUMAN OTC DRUG Painful Urination BERBERIS VULGARIS ROOT BARK - TURPENTINE OIL - LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20100723 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BERBERIS VULGARIS ROOT BARK; TURPENTINE OIL; LYCOPODIUM CLAVATUM SPORE 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-015_48d94187-0ec5-4cef-a403-dbaa3a8265ee 68428-015 HUMAN OTC DRUG Calcarea Phos Kit Refill TRIBASIC CALCIUM PHOSPHATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TRIBASIC CALCIUM PHOSPHATE 30 [hp_C]/1 N 20181231 68428-016_0b53d3ab-cab7-4e27-aa96-aa6911931eff 68428-016 HUMAN OTC DRUG Skin Irritation ARSENIC TRIOXIDE - CALCIUM SULFATE ANHYDROUS - SODIUM PHOSPHATE, DIBASIC ANHYDROUS - SILICON DIOXIDE PELLET ORAL 20100707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-017_ca64286d-ac34-4056-8291-5b1170fe67d1 68428-017 HUMAN OTC DRUG Acne ANTIMONY TRISULFIDE - MAHONIA AQUIFOLIUM ROOT BARK - LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20100402 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY TRISULFIDE; MAHONIA AQUIFOLIUM ROOT BARK; SEPIA OFFICINALIS JUICE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-018_2ad16c5e-78a8-4b9f-a903-538e6f0fa9df 68428-018 HUMAN OTC DRUG Colds and Cough ACONITUM NAPELLUS - BRYONIA ALBA ROOT - SANGUINARIA CANADENSIS ROOT PELLET ORAL 20100402 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS; BRYONIA ALBA ROOT; SANGUINARIA CANADENSIS ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-019_d68a0cbf-38ec-43bf-8628-1658aa84a0b5 68428-019 HUMAN OTC DRUG Head Cold POTASSIUM MERCURIC IODIDE - GELSEMIUM SEMPERVIRENS ROOT - EUPHRASIA STRICTA PELLET ORAL 20100824 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM MERCURIC IODIDE; GELSEMIUM SEMPERVIRENS ROOT; EUPHRASIA STRICTA 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-020_799e319c-93b4-4c3d-b0dc-44424044c723 68428-020 HUMAN OTC DRUG Hot Flashes AMYL NITRITE - LACHESIS MUTA VENOM - SANGUINARIA CANADENSIS ROOT PELLET ORAL 20100402 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMYL NITRITE; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-021_8c53dc97-a629-4411-82b2-1e4fa03d19d9 68428-021 HUMAN OTC DRUG Insomnia MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - PASSIFLORA INCARNATA TOP PELLET ORAL 20100402 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MATRICARIA RECUTITA; ARABICA COFFEE BEAN; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA TOP 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-022_63830192-4f30-427a-b5f1-a29e54f869f5 68428-022 HUMAN OTC DRUG Low Back Pain BLACK COHOSH - COLCHICUM AUTUMNALE BULB - POTASSIUM IODIDE PELLET ORAL 20100727 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLACK COHOSH; COLCHICUM AUTUMNALE BULB; POTASSIUM IODIDE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-023_fdcd988f-7fa0-4a7a-895e-bd5b7820cfb5 68428-023 HUMAN OTC DRUG Headache EPIFAGUS VIRGINIANA - IRIS VERSICOLOR ROOT - STRYCHNOS NUX-VOMICA SEED PELLET ORAL 20100331 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EPIFAGUS VIRGINIANA; IRIS VERSICOLOR ROOT; STRYCHNOS NUX-VOMICA SEED 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-024_9b1c18b6-bf16-4637-821b-3174524d7b19 68428-024 HUMAN OTC DRUG Motion Sickness ANAMIRTA COCCULUS SEED - STRYCHNOS NUX-VOMICA SEED - KEROSENE PELLET ORAL 20100505 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANAMIRTA COCCULUS SEED; STRYCHNOS NUX-VOMICA SEED; KEROSENE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-025_19efeb51-326c-4578-84d6-b487798ec3a6 68428-025 HUMAN OTC DRUG Stop Smoking DIEFFENBACHIA SEGUINE - DAPHNE ODORA BARK - STRYCHNOS NUX-VOMICA SEED - PLANTAGO MAJOR - DELPHINIUM STAPHISAGRIA SEED - TOBACCO LEAF PELLET ORAL 20100402 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIEFFENBACHIA SEGUINE; DAPHNE ODORA BARK; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF 6; 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-026_1e705382-f746-4975-ae01-050598befeed 68428-026 HUMAN OTC DRUG Aconitum Napellus Kit Refill ACONITUM NAPELLUS PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS 200 [hp_C]/1 N 20181231 68428-027_3e7d3364-85fd-49ef-85f5-22dbbe073ca8 68428-027 HUMAN OTC DRUG Calcarea Phos Kit Refill TRIBASIC CALCIUM PHOSPHATE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TRIBASIC CALCIUM PHOSPHATE 200 [hp_C]/1 N 20181231 68428-028_22114a37-6ba7-45fb-8573-0e58b88c0368 68428-028 HUMAN OTC DRUG Allium Cepa Kit Refill ONION PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ONION 200 [hp_C]/1 N 20181231 68428-029_adadb1cf-2e75-43e7-aad3-1898c0168136 68428-029 HUMAN OTC DRUG Antimonium Tart Kit Refill ANTIMONY POTASSIUM TARTRATE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY POTASSIUM TARTRATE 200 [hp_C]/1 N 20181231 68428-030_377342ee-b4a5-4460-84e0-269c9edea610 68428-030 HUMAN OTC DRUG Apis Mellifica Kit Refill APIS MELLIFERA PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products APIS MELLIFERA 200 [hp_C]/1 N 20181231 68428-031_66340c97-3e36-45e3-9141-195fa0bcaa3a 68428-031 HUMAN OTC DRUG Argentum Nitricum Kit Refill SILVER NITRATE PELLET ORAL 20100506 UNAPPROVED HOMEOPATHIC Washington 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68428-036_f61e82b2-934a-4585-a1e5-0fa2b1195734 68428-036 HUMAN OTC DRUG Calcarea Carbonica Kit Refill OYSTER SHELL CALCIUM CARBONATE, CRUDE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products OYSTER SHELL CALCIUM CARBONATE, CRUDE 200 [hp_C]/1 N 20181231 68428-037_adbefdd1-7dab-4c53-be4b-2a0b66f93031 68428-037 HUMAN OTC DRUG Calendula Officinalis Kit Refill CALENDULA OFFICINALIS FLOWERING TOP PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALENDULA OFFICINALIS FLOWERING TOP 200 [hp_C]/1 N 20181231 68428-038_b490a49b-f6d1-43fc-bb96-509ef3a38653 68428-038 HUMAN OTC DRUG Cantharis Kit Refill LYTTA VESICATORIA PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYTTA VESICATORIA 200 [hp_C]/1 N 20181231 68428-039_2bfd4061-71a3-454c-94cb-9e0035187138 68428-039 HUMAN OTC DRUG Carbo Vegetabilis Kit Refill ACTIVATED CHARCOAL PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACTIVATED CHARCOAL 200 [hp_C]/1 N 20181231 68428-040_f1d0a6f7-23b3-414c-8ea0-9f45cfe88c42 68428-040 HUMAN OTC DRUG Caulophyllum Thal Kit Refill CAULOPHYLLUM THALICTROIDES ROOT PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAULOPHYLLUM THALICTROIDES ROOT 200 [hp_C]/1 N 20181231 68428-041_e8cf756d-c44d-45dd-9622-038a9ae8182d 68428-041 HUMAN OTC DRUG Causticum Kit Refill CAUSTICUM PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAUSTICUM 200 [hp_C]/1 N 20181231 68428-042_0600c2fc-ef26-4d52-b668-52f50aceff2c 68428-042 HUMAN OTC DRUG Chamomilla Kit Refill MATRICARIA RECUTITA PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MATRICARIA RECUTITA 200 [hp_C]/1 N 20181231 68428-043_7436eb61-4321-40b5-9a3e-4dd73ed6827e 68428-043 HUMAN OTC DRUG Cinchona Officinalis Kit Refill CINCHONA OFFICINALIS BARK PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CINCHONA OFFICINALIS BARK 200 [hp_C]/1 N 20181231 68428-044_b78487e8-e2fb-48a7-bc06-83ef4b3970f2 68428-044 HUMAN OTC DRUG Cocculus Indicus Kit Refill ANAMIRTA COCCULUS SEED PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANAMIRTA COCCULUS SEED 200 [hp_C]/1 N 20181231 68428-045_f1f89e0d-5eb4-4d28-9d57-0dcf0b354942 68428-045 HUMAN OTC DRUG Coffea Cruda Kit Refill ARABICA COFFEE BEAN PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARABICA COFFEE BEAN 200 [hp_C]/1 N 20181231 68428-046_5f8817c9-71d3-4a55-9f77-7cb97238406a 68428-046 HUMAN OTC DRUG Colocynthis Kit Refill CITRULLUS COLOCYNTHIS FRUIT PULP PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CITRULLUS COLOCYNTHIS FRUIT PULP 200 [hp_C]/1 N 20181231 68428-047_f00a2d3e-ff1a-4471-878a-79cdb4303fe2 68428-047 HUMAN OTC DRUG Euphrasia Officinalis Kit Refill EUPHRASIA STRICTA PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPHRASIA STRICTA 200 [hp_C]/1 N 20181231 68428-048_c958e7cb-e89f-426f-a74d-425d99ce28e3 68428-048 HUMAN OTC DRUG Ferrum Phos Kit Refill FERRUM PHOSPHORICUM PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERRUM PHOSPHORICUM 200 [hp_C]/1 N 20181231 68428-049_7e954553-fdd5-44cd-a171-2467ba9f2531 68428-049 HUMAN OTC DRUG Gelsemium Semp Kit Refill GELSEMIUM SEMPERVIRENS ROOT PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GELSEMIUM SEMPERVIRENS ROOT 200 [hp_C]/1 N 20181231 68428-050_6658017c-6238-4b1a-9d81-8a512db65667 68428-050 HUMAN OTC DRUG Glonoinum Kit Refill NITROGLYCERIN PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NITROGLYCERIN 200 [hp_C]/1 N 20181231 68428-051_56a82a20-88c6-4a0b-b4f9-6650ac913b7f 68428-051 HUMAN OTC DRUG Hepar Sulph Calc Kit Refill CALCIUM SULFIDE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM SULFIDE 200 [hp_C]/1 N 20181231 68428-052_edc1c2ca-6b9e-47b1-9b54-c3be5e1e6990 68428-052 HUMAN OTC DRUG Hypericum Perf Kit Refill HYPERICUM PERFORATUM PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HYPERICUM PERFORATUM 200 [hp_C]/1 N 20181231 68428-053_1223495c-a192-4b6d-9309-3447247f8cbc 68428-053 HUMAN OTC DRUG Ignatia Amara Kit Refill STRYCHNOS IGNATII SEED PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STRYCHNOS IGNATII SEED 200 [hp_C]/1 N 20181231 68428-054_cadad0ce-b68c-44c0-8b32-7862220f9feb 68428-054 HUMAN OTC DRUG Ipecacuanha Kit Refill IPECAC PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IPECAC 200 [hp_C]/1 N 20181231 68428-055_656feb85-a0e4-4ed8-9c4a-1bfe33f9a594 68428-055 HUMAN OTC DRUG Kali Bichromicum Kit Refill POTASSIUM DICHROMATE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM DICHROMATE 200 [hp_C]/1 N 20181231 68428-056_c7824253-0168-4115-8728-0e760d8b74f4 68428-056 HUMAN OTC DRUG Lachesis Mutus Kit Refill LACHESIS MUTA VENOM PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACHESIS MUTA VENOM 200 [hp_C]/1 N 20181231 68428-057_d604d029-454c-41fa-98b7-3a3bf1f88250 68428-057 HUMAN OTC DRUG Ledum Palustre Kit Refill LEDUM PALUSTRE TWIG PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEDUM PALUSTRE TWIG 200 [hp_C]/1 N 20181231 68428-058_f8366a0f-a0d0-4c9b-8877-bbcb8b5e588a 68428-058 HUMAN OTC DRUG Lycopodium Kit Refill LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYCOPODIUM CLAVATUM SPORE 200 [hp_C]/1 N 20181231 68428-059_b90b0b19-51cc-402f-b463-c1669bce739d 68428-059 HUMAN OTC DRUG Magnesia Phos Kit Refill MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 200 [hp_C]/1 N 20181231 68428-060_4b00db1c-2cf3-480b-8df7-c6f247a2dda1 68428-060 HUMAN OTC DRUG Mercurius Vivus Kit Refill MERCURY PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURY 200 [hp_C]/1 N 20181231 68428-061_d4459ee3-857c-41bc-9633-99541e27c9d4 68428-061 HUMAN OTC DRUG Natrum Muriaticum Kit Refill SODIUM CHLORIDE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM CHLORIDE 200 [hp_C]/1 N 20181231 68428-062_56b22319-cbed-4c94-8b38-b5d3ca59a5d5 68428-062 HUMAN OTC DRUG Nux Vomica Kit Refill STRYCHNOS NUX-VOMICA SEED PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STRYCHNOS NUX-VOMICA SEED 200 [hp_C]/1 N 20181231 68428-063_0ce787e3-5861-4b9e-a0f2-a9e1e8faa204 68428-063 HUMAN OTC DRUG Phosphorus Kit Refill PHOSPHORUS PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHOSPHORUS 200 [hp_C]/1 N 20181231 68428-064_d8f3014e-c6c3-4bbd-b596-50a3b1bb8a1d 68428-064 HUMAN OTC DRUG Phytolacca Kit Refill PHYTOLACCA AMERICANA ROOT PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHYTOLACCA AMERICANA ROOT 200 [hp_C]/1 N 20181231 68428-065_6441b8a8-1ea5-43e2-9972-ff6d02808323 68428-065 HUMAN OTC DRUG Pulsatilla Kit Refill PULSATILLA VULGARIS PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PULSATILLA VULGARIS 200 [hp_C]/1 N 20181231 68428-066_6f4055ee-fe91-44a2-bf45-ea68f7bc44e6 68428-066 HUMAN OTC DRUG Pyrogenium Kit Refill RANCID BEEF PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RANCID BEEF 200 [hp_C]/1 N 20181231 68428-067_66544af9-45fe-4242-afb0-352e51e80759 68428-067 HUMAN OTC DRUG Rhus Tox Kit Refill TOXICODENDRON RADICANS LEAF PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TOXICODENDRON RADICANS LEAF 200 [hp_C]/1 N 20181231 68428-068_0c040097-54e1-4445-b9b4-13c08217562f 68428-068 HUMAN OTC DRUG Ruta Graveolens Kit Refill RUTA GRAVEOLENS FLOWERING TOP PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RUTA GRAVEOLENS FLOWERING TOP 200 [hp_C]/1 N 20181231 68428-069_2d6bcbc7-eccb-41c0-a568-c27b9cf02a99 68428-069 HUMAN OTC DRUG Sepia Kit Refill SEPIA OFFICINALIS JUICE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SEPIA OFFICINALIS JUICE 200 [hp_C]/1 N 20181231 68428-070_c98279d7-9a29-4541-b441-682bc39198df 68428-070 HUMAN OTC DRUG Silicea Kit Refill SILICON DIOXIDE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SILICON DIOXIDE 200 [hp_C]/1 N 20181231 68428-071_45365045-cbdd-4adc-8588-c13f9966e92a 68428-071 HUMAN OTC DRUG Spongia Tosta Kit Refill SILICON DIOXIDE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SPONGIA OFFICINALIS SKELETON, ROASTED 200 [hp_C]/1 N 20181231 68428-072_4491eb1c-ad7b-437d-bdce-65916a477286 68428-072 HUMAN OTC DRUG Staphysagria Kit Refill DELPHINIUM STAPHISAGRIA SEED PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DELPHINIUM STAPHISAGRIA SEED 200 [hp_C]/1 N 20181231 68428-073_42c40351-b328-4338-b259-76ec0a914ac6 68428-073 HUMAN OTC DRUG Sulphur Kit Refill SULFUR PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SULFUR 200 [hp_C]/1 N 20181231 68428-074_bb32c1f6-7479-49b1-a838-cc4a4b362d95 68428-074 HUMAN OTC DRUG Symphytum Off Kit Refill COMFREY ROOT PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COMFREY ROOT 200 [hp_C]/1 N 20181231 68428-075_4961eb3a-ab2b-4b2e-8882-b9253f74c252 68428-075 HUMAN OTC DRUG Thuja Occidentalis Kit Refill THUJA OCCIDENTALIS LEAFY TWIG PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THUJA OCCIDENTALIS LEAFY TWIG 200 [hp_C]/1 N 20181231 68428-076_ebc89d54-014b-431a-bef6-cfbcd7a8655e 68428-076 HUMAN OTC DRUG Homeopathic Remedy Kit 200c 50 Remedy Kit PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS; ONION; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; LYTTA VESICATORIA; ACTIVATED CHARCOAL; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; CITRULLUS COLOCYNTHIS FRUIT PULP; EUPHRASIA STRICTA; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; CALCIUM SULFIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IPECAC; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURY; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON RADICANS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; DELPHINIUM STAPHISAGRIA SEED; SULFUR; COMFREY ROOT; THUJA OCCIDENTALIS LEAFY TWIG 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 68428-077_22024ef2-d355-4790-87e5-788cd62ab7b1 68428-077 HUMAN OTC DRUG Aconitum Napellus Kit Refill ACONITUM NAPELLUS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS 30 [hp_C]/1 N 20181231 68428-078_1614b7d7-0513-4c52-a100-5ee043495343 68428-078 HUMAN OTC DRUG Allium Cepa Kit Refill ONION PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ONION 30 [hp_C]/1 N 20181231 68428-079_ad912dbb-4ee5-4585-885c-a7513f6ea33c 68428-079 HUMAN OTC DRUG Antimonium Tart Kit Refill ANTIMONY POTASSIUM TARTRATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY POTASSIUM TARTRATE 30 [hp_C]/1 N 20181231 68428-080_780564ad-d02d-4b95-84b4-18e0c74c46e4 68428-080 HUMAN OTC DRUG Apis Mellifica Kit Refill APIS MELLIFERA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products APIS MELLIFERA 30 [hp_C]/1 N 20181231 68428-081_03e57823-40ec-4782-8210-d5734d4dbd21 68428-081 HUMAN OTC DRUG Argentum Nitricum Kit Refill SILVER NITRATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SILVER NITRATE 30 [hp_C]/1 N 20181231 68428-082_c7420322-5259-4187-92d8-6e2b2bc3bdae 68428-082 HUMAN OTC DRUG Arnica Montana Kit Refill ARNICA MONTANA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARNICA MONTANA 30 [hp_C]/1 N 20181231 68428-083_248bd6c3-161f-4ba6-8840-5fa159927929 68428-083 HUMAN OTC DRUG Arsenicum Album Kit Refill ARSENIC TRIOXIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIOXIDE 30 [hp_C]/1 N 20181231 68428-084_77aa7a3d-ad47-40c4-929e-2c6a6a1f1e8b 68428-084 HUMAN OTC DRUG Belladonna Kit Refill ATROPA BELLADONNA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ATROPA BELLADONNA 30 [hp_C]/1 N 20181231 68428-085_c6067ec0-8a7b-4747-9fa7-d7adfbf0c45a 68428-085 HUMAN OTC DRUG Bryonia Alba Kit Refill BRYONIA ALBA ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BRYONIA ALBA ROOT 30 [hp_C]/1 N 20181231 68428-086_ff91e47d-19df-4a96-8e13-a26a52b42ffe 68428-086 HUMAN OTC DRUG Calcarea Carbonica Kit Refill OYSTER SHELL CALCIUM CARBONATE, CRUDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C]/1 N 20181231 68428-087_5eb0f134-7f2d-433e-bfc5-57ffb24bde51 68428-087 HUMAN OTC DRUG Calendula Officinalis Kit Refill CALENDULA OFFICINALIS FLOWERING TOP PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALENDULA OFFICINALIS FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-088_d024b578-429e-429f-a8ed-fb9a64c60052 68428-088 HUMAN OTC DRUG Cantharis Kit Refill LYTTA VESICATORIA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYTTA VESICATORIA 30 [hp_C]/1 N 20181231 68428-089_16916ee1-015e-49e6-b051-66d4eb5431f3 68428-089 HUMAN OTC DRUG Carbo Vegetabilis Kit Refill ACTIVATED CHARCOAL PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACTIVATED CHARCOAL 30 [hp_C]/1 N 20181231 68428-090_ac993e91-e76d-4497-8f82-105437837530 68428-090 HUMAN OTC DRUG Caulophyllum Thal Kit Refill CAULOPHYLLUM THALICTROIDES ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAULOPHYLLUM THALICTROIDES ROOT 30 [hp_C]/1 N 20181231 68428-091_aa37374f-075e-4274-b9ed-80cd1ce5871f 68428-091 HUMAN OTC DRUG Causticum Kit Refill CAUSTICUM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAUSTICUM 30 [hp_C]/1 N 20181231 68428-092_3ab9a109-eec9-478e-ab81-4b321917f5ee 68428-092 HUMAN OTC DRUG Chamomilla Kit Refill MATRICARIA RECUTITA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MATRICARIA RECUTITA 30 [hp_C]/1 N 20181231 68428-093_28bd4819-dbb5-4657-888a-d15f622fc3db 68428-093 HUMAN OTC DRUG Cinchona Officinalis Kit Refill CINCHONA OFFICINALIS BARK PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CINCHONA OFFICINALIS BARK 30 [hp_C]/1 N 20181231 68428-094_a1e844a6-33a2-4617-b633-cfade5326251 68428-094 HUMAN OTC DRUG Cocculus Indicus Kit Refill ANAMIRTA COCCULUS SEED PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANAMIRTA COCCULUS SEED 30 [hp_C]/1 N 20181231 68428-095_41dffefc-1b72-4546-9958-4982d9a76564 68428-095 HUMAN OTC DRUG Coffea Cruda Kit Refill ARABICA COFFEE BEAN PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARABICA COFFEE BEAN 30 [hp_C]/1 N 20181231 68428-096_86f7e1d4-e1e2-4240-879e-e28d22e814ec 68428-096 HUMAN OTC DRUG Colocynthis Kit Refill CITRULLUS COLOCYNTHIS FRUIT PULP PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CITRULLUS COLOCYNTHIS FRUIT PULP 30 [hp_C]/1 N 20181231 68428-097_7e4cc308-ff8b-4841-961e-98b6c1162029 68428-097 HUMAN OTC DRUG Euphrasia Officinalis Kit Refill EUPHRASIA STRICTA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPHRASIA STRICTA 30 [hp_C]/1 N 20181231 68428-098_9afb3bb1-17e6-40ad-8bb2-e82c49a094e4 68428-098 HUMAN OTC DRUG Ferrum Phos Kit Refill FERRUM PHOSPHORICUM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERRUM PHOSPHORICUM 30 [hp_C]/1 N 20181231 68428-099_91a8abe6-27a8-4f12-ab2f-341e7ac105f3 68428-099 HUMAN OTC DRUG Gelsemium Semp Kit Refill GELSEMIUM SEMPERVIRENS ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GELSEMIUM SEMPERVIRENS ROOT 30 [hp_C]/1 N 20181231 68428-100_fc823950-1ce2-4d6e-8c5e-66ab60b919fd 68428-100 HUMAN OTC DRUG Glonoinum Kit Refill NITROGLYCERIN PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NITROGLYCERIN 30 [hp_C]/1 N 20181231 68428-101_e7875e44-1168-4b45-991a-b4bc7d10aedb 68428-101 HUMAN OTC DRUG Hepar Sulph Calc Kit Refill CALCIUM SULFIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM SULFIDE 30 [hp_C]/1 N 20181231 68428-102_7deb178f-e16b-4b67-9857-ec49c8f2359f 68428-102 HUMAN OTC DRUG Hypericum Perf Kit Refill HYPERICUM PERFORATUM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HYPERICUM PERFORATUM 30 [hp_C]/1 N 20181231 68428-103_588b727f-c9e9-4ee6-9386-b5b857bef04e 68428-103 HUMAN OTC DRUG Ignatia Amara Kit Refill STRYCHNOS IGNATII SEED PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STRYCHNOS IGNATII SEED 30 [hp_C]/1 N 20181231 68428-104_8e7da391-0115-4730-b4f2-22e23d3b5911 68428-104 HUMAN OTC DRUG Ipecacuanha Kit Refill IPECAC PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IPECAC 30 [hp_C]/1 N 20181231 68428-105_d9f7042f-5d26-4581-8207-9440931ddf7b 68428-105 HUMAN OTC DRUG Kali Bichromicum Kit Refill POTASSIUM DICHROMATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM DICHROMATE 30 [hp_C]/1 N 20181231 68428-106_f6e60533-306f-445b-8396-d5d9cdf1fa57 68428-106 HUMAN OTC DRUG Lachesis Mutus Kit Refill LACHESIS MUTA VENOM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACHESIS MUTA VENOM 30 [hp_C]/1 N 20181231 68428-107_740b001a-dc99-4ec7-9e70-387a7293b8de 68428-107 HUMAN OTC DRUG Ledum Palustre Kit Refill LEDUM PALUSTRE TWIG PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEDUM PALUSTRE TWIG 30 [hp_C]/1 N 20181231 68428-108_bb3909ad-542a-4273-80e2-761c62acdba0 68428-108 HUMAN OTC DRUG Lycopodium Kit Refill LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/1 N 20181231 68428-109_28309324-4e42-47df-b044-2a24ca8b1b51 68428-109 HUMAN OTC DRUG Magnesia Phos Kit Refill MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 30 [hp_C]/1 N 20181231 68428-110_b713c312-b805-4a25-9046-2c92c57ca10d 68428-110 HUMAN OTC DRUG Mercurius Vivus Kit Refill MERCURY PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURY 300 [hp_C]/1 N 20181231 68428-111_b0b4d774-617a-4e51-bd86-761729619e2d 68428-111 HUMAN OTC DRUG Natrum Muriaticum Kit Refill SODIUM CHLORIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM CHLORIDE 30 [hp_C]/1 N 20181231 68428-112_268eae26-0b6d-4ae0-9cd2-ab4373c67b3b 68428-112 HUMAN OTC DRUG Nux Vomica Kit Refill STRYCHNOS NUX-VOMICA SEED PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/1 N 20181231 68428-113_9572c7db-e5f4-475f-b117-87180de6eb50 68428-113 HUMAN OTC DRUG Phosphorus Kit Refill PHOSPHORUS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHOSPHORUS 30 [hp_C]/1 N 20181231 68428-114_1551a077-b68f-4e26-bfd5-c6ebde6e6f12 68428-114 HUMAN OTC DRUG Phytolacca Kit Refill PHYTOLACCA AMERICANA ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHYTOLACCA AMERICANA ROOT 30 [hp_C]/1 N 20181231 68428-115_e5b68a79-a971-428a-b93c-549597656291 68428-115 HUMAN OTC DRUG Pulsatilla Kit Refill PULSATILLA VULGARIS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PULSATILLA VULGARIS 30 [hp_C]/1 N 20181231 68428-116_6437ec56-eab1-4ae4-a805-6f06e7040167 68428-116 HUMAN OTC DRUG Pyrogenium Kit Refill RANCID BEEF PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RANCID BEEF 30 [hp_C]/1 N 20181231 68428-117_77214e99-210c-4a1d-ba66-35e0b3efb212 68428-117 HUMAN OTC DRUG Rhus Tox Kit Refill TOXICODENDRON RADICANS LEAF PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TOXICODENDRON RADICANS LEAF 30 [hp_C]/1 N 20181231 68428-118_b93af7e0-f611-4af6-9bde-cf53fd5cf8bb 68428-118 HUMAN OTC DRUG Ruta Graveolens Kit Refill RUTA GRAVEOLENS FLOWERING TOP PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RUTA GRAVEOLENS FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-119_0314166a-898e-4994-8a1f-b42ce7832fe0 68428-119 HUMAN OTC DRUG Sepia Kit Refill SEPIA OFFICINALIS JUICE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SEPIA OFFICINALIS JUICE 30 [hp_C]/1 N 20181231 68428-120_1caaf30b-4435-4139-b945-5ce66a88965f 68428-120 HUMAN OTC DRUG Silicea Kit Refill SILICON DIOXIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SILICON DIOXIDE 30 [hp_C]/1 N 20181231 68428-121_2c00a120-c8b2-424f-be52-c4ceb0dfdef6 68428-121 HUMAN OTC DRUG Spongia Tosta Kit Refill SILICON DIOXIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_C]/1 N 20181231 68428-122_b0431e68-b8f4-45fa-81ef-3c7243cf5e8b 68428-122 HUMAN OTC DRUG Staphysagria Kit Refill DELPHINIUM STAPHISAGRIA SEED PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DELPHINIUM STAPHISAGRIA SEED 30 [hp_C]/1 N 20181231 68428-123_ce712653-b393-4016-9cab-d0a1665fe8cd 68428-123 HUMAN OTC DRUG Sulphur Kit Refill SULFUR PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SULFUR 30 [hp_C]/1 N 20181231 68428-124_9423a5a3-2b72-4cbb-a7e3-5be55cd7b5a0 68428-124 HUMAN OTC DRUG Symphytum Off Kit Refill COMFREY ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COMFREY ROOT 30 [hp_C]/1 N 20181231 68428-125_78b304af-a3b4-4358-9902-fe42bf4d259e 68428-125 HUMAN OTC DRUG Thuja Occidentalis Kit Refill THUJA OCCIDENTALIS LEAFY TWIG PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_C]/1 N 20181231 68428-126_a9cf4400-49f0-4aec-813d-f6f8bbc86fb9 68428-126 HUMAN OTC DRUG Homeopathic Remedy Kit 30c 50 Remedy Kit PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS; ONION; ANTIMONY POTASSIUM TARTRATE; APIS MELLIFERA; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; CALENDULA OFFICINALIS FLOWERING TOP; LYTTA VESICATORIA; ACTIVATED CHARCOAL; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; CITRULLUS COLOCYNTHIS FRUIT PULP; EUPHRASIA STRICTA; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT; NITROGLYCERIN; CALCIUM SULFIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; IPECAC; POTASSIUM DICHROMATE; LACHESIS MUTA VENOM; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURY; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RANCID BEEF; TOXICODENDRON RADICANS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; DELPHINIUM STAPHISAGRIA SEED; SULFUR; COMFREY ROOT; THUJA OCCIDENTALIS LEAFY TWIG 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-127_572a2853-e558-488c-a083-bb1b566b140b 68428-127 HUMAN OTC DRUG Aesculus Hipp Kit Refill HORSE CHESTNUT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HORSE CHESTNUT 30 [hp_C]/1 N 20181231 68428-128_9dfaf311-714f-4385-a9a3-e1b942cdf18a 68428-128 HUMAN OTC DRUG Agaricus Muscarius Kit Refill AMANITA MUSCARIA VAR. MUSCARIA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMANITA MUSCARIA VAR. 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68428-137_9254f34a-622c-4d24-8660-2bd08548c6e6 68428-137 HUMAN OTC DRUG Calcarea Sulphurica Kit Refill CALCIUM SULFATE ANHYDROUS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM SULFATE ANHYDROUS 30 [hp_C]/1 N 20181231 68428-138_904501c8-b8ff-47d6-90d2-10ea1b2804b1 68428-138 HUMAN OTC DRUG Cimicifuga Racemosa Kit Refill BLACK COHOSH PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLACK COHOSH 30 [hp_C]/1 N 20181231 68428-139_467dfa8d-6ac1-46ff-a774-77982f673626 68428-139 HUMAN OTC DRUG Conium Maculatum Kit Refill CONIUM MACULATUM FLOWERING TOP PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CONIUM MACULATUM FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-140_218739d8-e513-4914-91dc-47842f780dff 68428-140 HUMAN OTC DRUG Cuprum Metallicum Kit Refill COPPER PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COPPER 30 [hp_C]/1 N 20181231 68428-141_af222bc0-21c4-4079-9124-dd2f0f950d87 68428-141 HUMAN OTC DRUG Digitalis Purpurea Kit Refill DIGITALIS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIGITALIS 30 [hp_C]/1 N 20181231 68428-142_d24b4abd-3d2f-4ea9-a6fb-5d9fea0c10f1 68428-142 HUMAN OTC DRUG Drosera Rotundifolia Kit Refill DROSERA ROTUNDIFOLIA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DROSERA ROTUNDIFOLIA 30 [hp_C]/1 N 20181231 68428-143_d9b642ed-33c6-41ec-927a-bd416aa065b7 68428-143 HUMAN OTC DRUG Echinacea Ang Kit Refill ECHINACEA ANGUSTIFOLIA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ECHINACEA ANGUSTIFOLIA 30 [hp_C]/1 N 20181231 68428-144_fafed6e1-d9b6-4725-8324-929cca6b6a98 68428-144 HUMAN OTC DRUG Eupatorium Perf Kit Refill EUPATORIUM PERFOLIATUM FLOWERING TOP PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPATORIUM PERFOLIATUM FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-145_d0b93c1b-c69d-43f2-b130-4fca9b8b8e5e 68428-145 HUMAN OTC DRUG Graphites Kit Refill GRAPHITE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GRAPHITE 30 [hp_C]/1 N 20181231 68428-146_88e43736-94f0-4304-94dc-8b580e5cd5d0 68428-146 HUMAN OTC DRUG Hamamelis Virginiana Kit Refill HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 30 [hp_C]/1 N 20181231 68428-147_fa42106e-b347-4b59-8d8d-25de437472aa 68428-147 HUMAN OTC DRUG Kali Carbonicum Kit Refill POTASSIUM CARBONATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM CARBONATE 30 [hp_C]/1 N 20181231 68428-148_6b61ba89-52fe-4c22-9d46-0d7f14007cfe 68428-148 HUMAN OTC DRUG Kali Muriaticum Kit Refill POTASSIUM CHLORIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM CHLORIDE 30 [hp_C]/1 N 20181231 68428-149_b0303d92-fec5-43b9-a38e-cc699a4c8e16 68428-149 HUMAN OTC DRUG Kali Phosphoricum Kit Refill POTASSIUM PHOSPHATE, DIBASIC PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM PHOSPHATE, DIBASIC 30 [hp_C]/1 N 20181231 68428-150_940a7f7d-7730-4351-a392-4cd9aef2cc85 68428-150 HUMAN OTC DRUG Lac Caninum Kit Refill CANIS LUPUS FAMILIARIS MILK PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CANIS LUPUS FAMILIARIS MILK 30 [hp_C]/1 N 20181231 68428-151_43e77339-10f4-4c4c-8466-45d9dab3fc32 68428-151 HUMAN OTC DRUG Mercurius Corr Kit Refill MERCURIC CHLORIDE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURIC CHLORIDE 30 [hp_C]/1 N 20181231 68428-152_0ae717b3-9117-42fc-bcbb-7de533f2088c 68428-152 HUMAN OTC DRUG Natrum Phos Kit Refill SODIUM PHOSPHATE, DIBASIC ANHYDROUS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM PHOSPHATE, DIBASIC ANHYDROUS 30 [hp_C]/1 N 20181231 68428-153_37f957b3-cdc7-4b39-8efc-27d4a24b14d2 68428-153 HUMAN OTC DRUG Natrum Sulphuricum Kit Refill SODIUM SULFATE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM SULFATE 30 [hp_C]/1 N 20181231 68428-154_f5040d17-fb33-479a-80f0-4fad6f38a6e7 68428-154 HUMAN OTC DRUG Petroleum Kit Refill KEROSENE PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products KEROSENE 30 [hp_C]/1 N 20181231 68428-155_2d4e8f5c-d196-42ea-9b10-ca571d36c84c 68428-155 HUMAN OTC DRUG Phosphoricum Acidum Kit Refill PHOSPHORIC ACID PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHOSPHORIC ACID 30 [hp_C]/1 N 20181231 68428-156_3a71eed5-7a5b-493f-b488-739d3fd107da 68428-156 HUMAN OTC DRUG Podophyllum Pelt Kit Refill PODOPHYLLUM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PODOPHYLLUM 30 [hp_C]/1 N 20181231 68428-157_ae2ff1b0-cb1d-4d4a-8dbe-d7565561c3a5 68428-157 HUMAN OTC DRUG Rumex Crispus Kit Refill RUMEX CRISPUS ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RUMEX CRISPUS ROOT 30 [hp_C]/1 N 20181231 68428-158_93d15d20-8713-4403-a278-b3c47d7dc641 68428-158 HUMAN OTC DRUG Sabadilla Kit Refill SCHOENOCAULON OFFICINALE SEED PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SCHOENOCAULON OFFICINALE SEED 30 [hp_C]/1 N 20181231 68428-159_da0e8294-ba84-4a51-bc98-9779634c95b9 68428-159 HUMAN OTC DRUG Sabina Kit Refill JUNIPERUS SABINA LEAF PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products JUNIPERUS SABINA LEAF 30 [hp_C]/1 N 20181231 68428-160_ad67817e-b4e3-4d77-bb25-95d1b58a2b85 68428-160 HUMAN OTC DRUG Sanguinaria Can Kit Refill SANGUINARIA CANADENSIS ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SANGUINARIA CANADENSIS ROOT 30 [hp_C]/1 N 20181231 68428-161_550bc7b7-9e88-4bc4-a1a1-f7cedfd60ca5 68428-161 HUMAN OTC DRUG Sarsaparilla Kit Refill SARSAPARILLA ROOT PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SARSAPARILLA ROOT 30 [hp_C]/1 N 20181231 68428-162_ea39c740-0486-462f-a7c7-b8713c44b41d 68428-162 HUMAN OTC DRUG Secale Cornutum Kit Refill CLAVICEPS PURPUREA SCLEROTIUM PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CLAVICEPS PURPUREA SCLEROTIUM 30 [hp_C]/1 N 20181231 68428-163_32f46255-e72c-4e90-9635-5b720bd0384d 68428-163 HUMAN OTC DRUG Spigelia Anthelmia Kit Refill SPIGELIA ANTHELMIA PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SPIGELIA ANTHELMIA 30 [hp_C]/1 N 20181231 68428-164_157fc270-c097-40ee-8dd9-5791f9b6c12a 68428-164 HUMAN OTC DRUG Urtica Urens Kit Refill URTICA URENS PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products URTICA URENS 30 [hp_C]/1 N 20181231 68428-165_7957a8ad-1d8d-425c-92ed-1bf0ad20b85c 68428-165 HUMAN OTC DRUG Valeriana Officinalis Kit Refill VALERIAN PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC 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FLOWER BUD 30; 30 [hp_C]/1; [hp_C]/1 N 20181231 68428-172_d71f382f-24bf-4d1a-968f-2c64108eb5a8 68428-172 HUMAN OTC DRUG Abies nigra PICEA MARIANA RESIN PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PICEA MARIANA RESIN 30 [hp_C]/1 N 20181231 68428-173_8fc7de9e-856c-4a99-b954-fe1c2500f4ac 68428-173 HUMAN OTC DRUG Abrotanum ARTEMISIA ABROTANUM FLOWERING TOP PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARTEMISIA ABROTANUM FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-174_67e1e505-aee7-497e-ab20-d0adea1e6bac 68428-174 HUMAN OTC DRUG Absinthium WORMWOOD PELLET ORAL 20101228 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products WORMWOOD 30 [hp_C]/1 N 20181231 68428-175_b58a152a-5cf9-49f6-8eda-bbf34cfbef0a 68428-175 HUMAN OTC DRUG Aceticum Acidum ACETIC ACID PELLET ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACETIC ACID 30 [hp_C]/1 N 20181231 68428-176_0d92453c-3a92-4a5c-99a4-6b06e9449dee 68428-176 HUMAN OTC DRUG Aconitum Ferox ACONITUM FEROX ROOT PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM FEROX ROOT 30 [hp_C]/1 N 20181231 68428-177_6d5ba325-246f-47f9-a79f-44d7b38433f9 68428-177 HUMAN OTC DRUG Aconitum napellus ACONITUM NAPELLUS PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS 30 [hp_C]/1 N 20181231 68428-178_cb903e9f-e07b-4bc8-8276-63ae9f18e4b7 68428-178 HUMAN OTC DRUG Actaea Spicata ACTAEA SPICATA ROOT PELLET ORAL 20110129 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACTAEA SPICATA ROOT 30 [hp_C]/1 N 20181231 68428-179_c0385b15-d4b1-41c2-b490-f84a73fb40fa 68428-179 HUMAN OTC DRUG Adonis vernalis ADONIS VERNALIS PELLET ORAL 20111205 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ADONIS VERNALIS 30 [hp_C]/1 N 20181231 68428-180_1092e16f-b24c-4197-b77a-bd1ee513197a 68428-180 HUMAN OTC DRUG Adrenalinum EPINEPHRINE PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EPINEPHRINE 30 [hp_C]/1 N 20181231 68428-181_d3affe6a-26d9-40ba-a8b9-592eb6b8fef4 68428-181 HUMAN OTC DRUG Adrenocorticotrophin CORTICOTROPIN PELLET ORAL 20110102 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CORTICOTROPIN 30 [hp_C]/1 N 20181231 68428-182_b147d520-8a25-499d-91f7-f5ed40e81175 68428-182 HUMAN OTC DRUG Aesculus hippocastanum HORSE CHESTNUT PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HORSE CHESTNUT 30 [hp_C]/1 N 20181231 68428-183_9627e6f4-c5e4-4ce8-bbb2-9f97debcb51a 68428-183 HUMAN OTC DRUG Aethusa Cynapium AETHUSA CYNAPIUM PELLET ORAL 20091127 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AETHUSA CYNAPIUM 30 [hp_C]/1 N 20181231 68428-184_0b0aaf70-55a2-43d5-b3af-1e3be59ff9d6 68428-184 HUMAN OTC DRUG Agaricus Muscarius AMANITA MUSCARIA VAR. MUSCARIA PELLET ORAL 20091022 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMANITA MUSCARIA FRUITING BODY 30 [hp_C]/1 N 20181231 68428-185_5ed4c3fe-c204-4c0c-a84a-2b7da8da11da 68428-185 HUMAN OTC DRUG Agnus CHASTE TREE PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHASTE TREE 30 [hp_C]/1 N 20181231 68428-186_d151f63b-126a-4535-8d48-3347d042646e 68428-186 HUMAN OTC DRUG Ailanthus AILANTHUS ALTISSIMA FLOWERING TWIG PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AILANTHUS ALTISSIMA FLOWERING TWIG 30 [hp_C]/1 N 20181231 68428-187_ffc4cd5d-e75e-4361-a8c1-beb39d8f1103 68428-187 HUMAN OTC DRUG Aletris farinosa ALETRIS FARINOSA ROOT PELLET ORAL 20100212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALETRIS FARINOSA ROOT 30 [hp_C]/1 N 20181231 68428-188_0067353a-63b9-4db0-a214-ee48036713e1 68428-188 HUMAN OTC DRUG Allium Cepa ONION PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ONION 30 [hp_C]/1 N 20181231 68428-189_9be55c06-2cd4-472e-ab82-74a58dfd1715 68428-189 HUMAN OTC DRUG Allium Sativum GARLIC PELLET ORAL 20100908 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GARLIC 30 [hp_C]/1 N 20181231 68428-190_32e91dc8-c72b-4f65-93c9-7abf67243a38 68428-190 HUMAN OTC DRUG Aloe Socotrina ALOE PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALOE 30 [hp_C]/1 N 20181231 68428-191_9210ed20-4931-4a94-856f-a22e40016194 68428-191 HUMAN OTC DRUG Althaea officinalis ALTHAEA OFFICINALIS ROOT PELLET ORAL 20090914 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALTHAEA OFFICINALIS ROOT 30 [hp_C]/1 N 20181231 68428-192_c64fd2c1-fbf5-4007-a30d-1837aaa30514 68428-192 HUMAN OTC DRUG Alumen POTASSIUM ALUM PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM ALUM 30 [hp_C]/1 N 20181231 68428-193_66d31c2d-2ed0-49a3-a1d4-db1de2c1ef04 68428-193 HUMAN OTC DRUG Alumina ALUMINUM OXIDE PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALUMINUM OXIDE 30 [hp_C]/1 N 20181231 68428-194_424e2799-2d17-4592-b6c7-389e73e57e43 68428-194 HUMAN OTC DRUG Aluminum metallicum ALUMINUM PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALUMINUM 30 [hp_C]/1 N 20181231 68428-195_191401f5-1167-47fa-9d9b-4b462970ed8b 68428-195 HUMAN OTC DRUG Ambra grisea AMBERGRIS PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMBERGRIS 30 [hp_C]/1 N 20181231 68428-196_b4539b94-e282-4d7a-a467-4c1c38275422 68428-196 HUMAN OTC DRUG Ambrosia artemisiaefolia AMBROSIA ARTEMISIIFOLIA PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMBROSIA ARTEMISIIFOLIA 30 [hp_C]/1 N 20181231 68428-197_f0119732-9163-487f-8c81-725913a9a46e 68428-197 HUMAN OTC DRUG Ammoniacum Gummi AMMONIAC PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIAC 30 [hp_C]/1 N 20181231 68428-198_a60671b6-af21-4880-b1a6-11daf346678b 68428-198 HUMAN OTC DRUG Ammonium carbonicum AMMONIUM CARBONATE PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM CARBONATE 30 [hp_C]/1 N 20181231 68428-199_8082fd4d-ff08-4618-910e-769040cb42d9 68428-199 HUMAN OTC DRUG Ammonium muriaticum AMMONIUM CHLORIDE PELLET ORAL 20101122 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM CHLORIDE 30 [hp_C]/1 N 20181231 68428-200_144f0f03-94db-45f3-864e-6aa5c7a5b2ff 68428-200 HUMAN OTC DRUG Ammonium phosphoricum AMMONIUM PHOSPHATE, DIBASIC PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM PHOSPHATE, DIBASIC 30 [hp_C]/1 N 20181231 68428-201_2148fc04-66a4-4c3d-93af-de140b5d0fcc 68428-201 HUMAN OTC DRUG Amygdalus persica PEACH PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PRUNUS PERSICA FLOWER 30 [hp_C]/1 N 20181231 68428-202_33df2968-be46-4f15-9420-2390c994756b 68428-202 HUMAN OTC DRUG Amyl nitrosum AMYL NITRITE PELLET ORAL 20090908 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMYL NITRITE 30 [hp_C]/1 N 20181231 68428-203_55960217-c4bf-4a5b-885a-38b807503193 68428-203 HUMAN OTC DRUG Anacardium occidentale ANACARDIUM OCCIDENTALE FRUIT PELLET ORAL 20100312 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANACARDIUM OCCIDENTALE FRUIT 30 [hp_C]/1 N 20181231 68428-204_da300da6-88c5-476e-bab8-e0acc7288272 68428-204 HUMAN OTC DRUG Anacardium orientale SEMECARPUS ANACARDIUM JUICE PELLET ORAL 20090831 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SEMECARPUS ANACARDIUM JUICE 30 [hp_C]/1 N 20181231 68428-205_80eacc77-e218-4071-b997-2638ecbd4dcc 68428-205 HUMAN OTC DRUG Anas barbariae, hepatis et cordis extractum CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE PELLET ORAL 20100504 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 30 [hp_C]/1 N 20181231 68428-206_4370c128-b267-49f5-a436-dc93e584ba86 68428-206 HUMAN OTC DRUG Anatherum muricatum CHRYSOPOGON ZIZANIOIDES ROOT PELLET ORAL 20090831 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHRYSOPOGON ZIZANIOIDES ROOT 30 [hp_C]/1 N 20181231 68428-207_0fc12e96-4ef1-4f4b-9240-1e807c05951d 68428-207 HUMAN OTC DRUG Angelica archangelica ANGELICA ARCHANGELICA ROOT PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANGELICA ARCHANGELICA ROOT 30 [hp_C]/1 N 20181231 68428-208_5ebb761e-8b57-427d-b733-53f7a8968ba2 68428-208 HUMAN OTC DRUG Angustura vera ANGOSTURA BARK PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANGOSTURA BARK 30 [hp_C]/1 N 20181231 68428-209_8e2afc74-3414-495a-addc-a03826e349af 68428-209 HUMAN OTC DRUG Anthoxanthum odoratum ANTHOXANTHUM ODORATUM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTHOXANTHUM ODORATUM 30 [hp_C]/1 N 20181231 68428-210_4fad71d2-f75e-412a-9d9f-d1a819b49426 68428-210 HUMAN OTC DRUG Anthracinum BACILLUS ANTHRACIS IMMUNOSERUM RABBIT PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 30 [hp_C]/1 N 20181231 68428-211_59c0f6bf-cfff-4b70-9f11-07bc32f1bb46 68428-211 HUMAN OTC DRUG Antimonium arsenicicum ANTIMONY ARSENATE PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY ARSENATE 30 [hp_C]/1 N 20181231 68428-212_171a1a77-da52-443c-8f8e-60d5cdb86668 68428-212 HUMAN OTC DRUG Antimonium crudum ANTIMONY TRISULFIDE PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY TRISULFIDE 30 [hp_C]/1 N 20181231 68428-213_716bb7dd-4aae-4c15-8384-209f2e08425f 68428-213 HUMAN OTC DRUG Antimonium tartaricum ANTIMONY POTASSIUM TARTRATE PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY POTASSIUM TARTRATE 30 [hp_C]/1 N 20181231 68428-214_62795993-1c32-498f-8800-bdfc2cd75c2e 68428-214 HUMAN OTC DRUG Apis mellifica APIS MELLIFERA PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products APIS MELLIFERA 30 [hp_C]/1 N 20181231 68428-215_63f62659-bd52-4cb3-8bfd-ea850eb77740 68428-215 HUMAN OTC DRUG Apis venenum purum APIS MELLIFERA VENOM PELLET ORAL 20100611 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products APIS MELLIFERA VENOM 30 [hp_C]/1 N 20181231 68428-216_e29c2ea5-e127-4260-8b8e-d1909df701ed 68428-216 HUMAN OTC DRUG Apium Graveolens CELERY SEED PELLET ORAL 20100708 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CELERY SEED 30 [hp_C]/1 N 20181231 68428-217_ae6412f7-33ee-490f-a54c-7d891a6116e0 68428-217 HUMAN OTC DRUG Apocynum cannabinum APOCYNUM CANNABINUM ROOT PELLET ORAL 20101004 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products APOCYNUM CANNABINUM ROOT 30 [hp_C]/1 N 20181231 68428-218_db13f75f-6cd0-40c1-bd7c-608faed1a315 68428-218 HUMAN OTC DRUG Aralia racemosa ARALIA RACEMOSA ROOT PELLET ORAL 20100809 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARALIA RACEMOSA ROOT 30 [hp_C]/1 N 20181231 68428-219_ea576068-9f8e-4b73-a65a-097ac8170b02 68428-219 HUMAN OTC DRUG Argentum iodatum SILVER IODIDE PELLET ORAL 20100201 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SILVER IODIDE 30 [hp_C]/1 N 20181231 68428-220_96905536-d588-4290-955f-b44ba5182099 68428-220 HUMAN OTC DRUG Argentum metallicum SILVER PELLET ORAL 20100202 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SILVER 30 [hp_C]/1 N 20181231 68428-221_c551e5f5-c9db-4d54-b4ae-ce6e8f2b177f 68428-221 HUMAN OTC DRUG Arg Nit SILVER NITRATE PELLET ORAL 20100504 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SILVER NITRATE 30 [hp_C]/1 N 20181231 68428-222_4c37b268-0741-4fc3-9cc0-9609128aef1c 68428-222 HUMAN OTC DRUG Aristolochia milhomens ARISTOLOCHIA CYMBIFERA FLOWER PELLET ORAL 20101019 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARISTOLOCHIA CYMBIFERA FLOWER 30 [hp_C]/1 N 20181231 68428-223_5316d83a-b506-4f71-8c2d-fad52cc2c857 68428-223 HUMAN OTC DRUG Arnica montana ARNICA MONTANA PELLET ORAL 20090828 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARNICA MONTANA 30 [hp_C]/1 N 20181231 68428-224_b1ccc61b-3e88-4fb5-9cc9-61b9caefc458 68428-224 HUMAN OTC DRUG Arnica montana, radix ARNICA MONTANA ROOT PELLET ORAL 20101011 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARNICA MONTANA ROOT 30 [hp_C]/1 N 20181231 68428-225_a896f460-c27e-47d3-b381-9fbddd01a895 68428-225 HUMAN OTC DRUG Arsenicum album ARSENIC TRIOXIDE PELLET ORAL 20090831 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIOXIDE 30 [hp_C]/1 N 20181231 68428-226_818bd2dd-a439-4585-bed1-59737d0aad03 68428-226 HUMAN OTC DRUG Arsenicum bromatum ARSENIC TRIBROMIDE PELLET ORAL 20100202 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIBROMIDE 30 [hp_C]/1 N 20181231 68428-227_ce8155d6-726b-412c-bb3a-bd78ad18620d 68428-227 HUMAN OTC DRUG Arsenicum iodatum ARSENIC TRIIODIDE PELLET ORAL 20080102 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIIODIDE 30 [hp_C]/1 N 20181231 68428-228_cbcaf1a1-66cc-4138-8c25-de9918f81017 68428-228 HUMAN OTC DRUG Arsenicum sulphuratum flavum ARSENIC TRISULFIDE PELLET ORAL 20101214 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRISULFIDE 30 [hp_C]/1 N 20181231 68428-229_d8bb8259-cd1f-4985-8f82-c6edbb771ff5 68428-229 HUMAN OTC DRUG Arum triphyllum ARISAEMA TRIPHYLLUM ROOT PELLET ORAL 20100614 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARISAEMA TRIPHYLLUM ROOT 30 [hp_C]/1 N 20181231 68428-230_e17ecd38-7665-465e-9793-1ab3fee76a29 68428-230 HUMAN OTC DRUG Arundo mauritanica ARUNDO PLINIANA ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARUNDO PLINIANA ROOT 30 [hp_C]/1 N 20181231 68428-231_3e3ab17c-1887-4cde-bb5e-d751766c9570 68428-231 HUMAN OTC DRUG Asafoetida ASAFETIDA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERULA ASSA-FOETIDA RESIN 30 [hp_C]/1 N 20181231 68428-232_661d27fb-f88c-4034-a819-40a9e1c46a2f 68428-232 HUMAN OTC DRUG Asarum europaeum ASARUM EUROPAEUM PELLET ORAL 20091120 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASARUM EUROPAEUM 30 [hp_C]/1 N 20181231 68428-233_03feb2ac-2a88-43d1-bb7b-057b69548d6f 68428-233 HUMAN OTC DRUG Asclepias tuberosa ASCLEPIAS TUBEROSA ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASCLEPIAS TUBEROSA ROOT 30 [hp_C]/1 N 20181231 68428-234_7d82a977-5e33-4411-ba34-cb2d0dedc95c 68428-234 HUMAN OTC DRUG Asparagus officinalis ASPARAGUS PELLET ORAL 20100810 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASPARAGUS 30 [hp_C]/1 N 20181231 68428-235_66a66016-0ea9-45a2-a009-c488850fe7b0 68428-235 HUMAN OTC DRUG Astacus fluviatilis ASTACUS ASTACUS PELLET ORAL 20101112 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASTACUS ASTACUS 30 [hp_C]/1 N 20181231 68428-236_9c3d0d6d-fb29-4b5e-b712-29749dedc4d2 68428-236 HUMAN OTC DRUG Asterias rubens ASTERIAS RUBENS PELLET ORAL 20100621 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASTERIAS RUBENS 30 [hp_C]/1 N 20181231 68428-237_4ac373ae-8494-40db-9fc3-5864cb18f4ab 68428-237 HUMAN OTC DRUG Atropinum ATROPINE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ATROPINE 30 [hp_C]/1 N 20181231 68428-238_205a41ca-d042-46e8-89de-cb1aaaa15018 68428-238 HUMAN OTC DRUG Aurum bromatum GOLD TRIBROMIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GOLD TRIBROMIDE 30 [hp_C]/1 N 20181231 68428-239_e7c82396-ebfb-4cbb-97ba-f48bdaeaf3a5 68428-239 HUMAN OTC DRUG Aurum iodatum GOLD MONOIODIDE PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GOLD MONOIODIDE 30 [hp_C]/1 N 20181231 68428-240_d09a3a13-dc36-4afb-b529-1689d48b6fd5 68428-240 HUMAN OTC DRUG Aurum metallicum GOLD PELLET ORAL 20100212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GOLD 30 [hp_C]/1 N 20181231 68428-241_6c61f61d-005a-446f-a1ac-93a844a1a011 68428-241 HUMAN OTC DRUG Aurum muriaticum GOLD TRICHLORIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GOLD TRICHLORIDE 30 [hp_C]/1 N 20181231 68428-242_7b5ffe6d-20b7-4a2e-92f0-8512ee6e6b58 68428-242 HUMAN OTC DRUG Aurum muriaticum natronatum SODIUM TETRACHLOROAURATE PELLET ORAL 20100621 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM TETRACHLOROAURATE 30 [hp_C]/1 N 20181231 68428-243_2248dd9b-d532-4029-aba9-92a30e8925ec 68428-243 HUMAN OTC DRUG Aurum sulphuratum GOLD MONOSULFIDE PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GOLD MONOSULFIDE 30 [hp_C]/1 N 20181231 68428-244_b454eade-7c7d-4260-bfb9-e5d4e63985b8 68428-244 HUMAN OTC DRUG Avena sativa AVENA SATIVA FLOWERING TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AVENA SATIVA FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-245_4f3bc280-4770-48b1-990f-1d885031da59 68428-245 HUMAN OTC DRUG Azadirachta indica AZADIRACHTA INDICA BARK PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AZADIRACHTA INDICA BARK 30 [hp_C]/1 N 20181231 68428-246_2855ae24-7dfc-490b-93eb-5623be30a387 68428-246 HUMAN OTC DRUG Badiaga SPONGILLA LACUSTRIS PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SPONGILLA LACUSTRIS 30 [hp_C]/1 N 20181231 68428-247_7e67f85e-254b-4447-8946-d9af858d6143 68428-247 HUMAN OTC DRUG Baptisia tinctoria BAPTISIA TINCTORIA ROOT PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BAPTISIA TINCTORIA ROOT 30 [hp_C]/1 N 20181231 68428-248_ff935714-38e2-4b1b-8bc3-8afb099ab046 68428-248 HUMAN OTC DRUG Baryta carbonica BARIUM CARBONATE PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BARIUM CARBONATE 30 [hp_C]/1 N 20181231 68428-249_647bc776-7b3a-41b4-865e-4a5bb840c65d 68428-249 HUMAN OTC DRUG Baryta iodata BARIUM IODIDE PELLET ORAL 20091005 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BARIUM IODIDE 30 [hp_C]/1 N 20181231 68428-250_34454f39-83eb-4d90-9749-8c73dd33faeb 68428-250 HUMAN OTC DRUG Baryta muriatica BARIUM CHLORIDE DIHYDRATE PELLET ORAL 20091215 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BARIUM CHLORIDE DIHYDRATE 30 [hp_C]/1 N 20181231 68428-251_9d1153e3-39aa-4833-af0c-d15756b531c2 68428-251 HUMAN OTC DRUG Belladonna ATROPA BELLADONNA PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ATROPA BELLADONNA 30 [hp_C]/1 N 20181231 68428-252_139117e8-3d7f-4aa9-8fd0-07dcca8f1b0a 68428-252 HUMAN OTC DRUG Bellis perennis BELLIS PERENNIS PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BELLIS PERENNIS 30 [hp_C]/1 N 20181231 68428-253_957af9dc-5576-4875-8b3f-3572a8c1435c 68428-253 HUMAN OTC DRUG Benzinum BENZENE PELLET ORAL 20100412 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BENZENE 30 [hp_C]/1 N 20181231 68428-254_f04b5141-2d2c-4a55-96bb-27c8504961c1 68428-254 HUMAN OTC DRUG Benzoicum Ac BENZOIC ACID PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BENZOIC ACID 30 [hp_C]/1 N 20181231 68428-255_edb9c32c-a035-464d-bef1-7533fd08d27e 68428-255 HUMAN OTC DRUG Benzoinum STYRAX BENZOIN RESIN PELLET ORAL 20101213 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STYRAX BENZOIN RESIN 30 [hp_C]/1 N 20181231 68428-256_8a57e9aa-e26a-4083-9f91-dd4eeba366ca 68428-256 HUMAN OTC DRUG Berberis aquifolium MAHONIA AQUIFOLIUM ROOT BARK PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MAHONIA AQUIFOLIUM ROOT BARK 30 [hp_C]/1 N 20181231 68428-257_dd7360c5-20ed-4a7e-b48e-f0658dcc78be 68428-257 HUMAN OTC DRUG Berberis vulgaris BERBERIS VULGARIS ROOT BARK PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BERBERIS VULGARIS ROOT BARK 30 [hp_C]/1 N 20181231 68428-258_2dd909af-4f81-46d2-b2af-4cfe415da1bb 68428-258 HUMAN OTC DRUG Bismuthum metallicum BISMUTH PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BISMUTH 30 [hp_C]/1 N 20181231 68428-259_09bdd9b7-7503-4ae5-b212-5f7aa4dcc8db 68428-259 HUMAN OTC DRUG Blatta orientalis BLATTA ORIENTALIS PELLET ORAL 20101230 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLATTA ORIENTALIS 30 [hp_C]/1 N 20181231 68428-260_04893952-68dd-42d0-8b3d-787238088bd8 68428-260 HUMAN OTC DRUG Boldo PEUMUS BOLDUS LEAF PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PEUMUS BOLDUS LEAF 30 [hp_C]/1 N 20181231 68428-261_7eca0648-c4ff-455d-8245-5d5ce1b2d908 68428-261 HUMAN OTC DRUG Borax SODIUM BORATE PELLET ORAL 20100513 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM BORATE 30 [hp_C]/1 N 20181231 68428-262_1995e840-d7a2-455d-9cee-e1f23deb4690 68428-262 HUMAN OTC DRUG Boricum acidum BORIC ACID PELLET ORAL 20100921 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BORIC ACID 30 [hp_C]/1 N 20181231 68428-263_a5b37095-f784-4fe9-9bd2-254b953b4115 68428-263 HUMAN OTC DRUG Bovista LYCOPERDON UTRIFORME FRUITING BODY PELLET ORAL 20091123 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYCOPERDON UTRIFORME FRUITING BODY 30 [hp_C]/1 N 20181231 68428-264_905b1feb-0190-46ac-a2db-c539fd572ce7 68428-264 HUMAN OTC DRUG Bromium BROMINE PELLET ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BROMINE 30 [hp_C]/1 N 20181231 68428-265_00376351-07c1-4f01-835d-9efdcf793022 68428-265 HUMAN OTC DRUG Bryonia alba BRYONIA ALBA ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BRYONIA ALBA ROOT 30 [hp_C]/1 N 20181231 68428-266_888f27db-e2af-4805-872c-341e7190d68f 68428-266 HUMAN OTC DRUG Bufo BUFO BUFO CUTANEOUS GLAND PELLET ORAL 20100517 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BUFO BUFO CUTANEOUS GLAND 30 [hp_C]/1 N 20181231 68428-267_a615947a-4e5d-4c97-a1a4-2ca81ecd539a 68428-267 HUMAN OTC DRUG Cactus grandiflorus SELENICEREUS GRANDIFLORUS STEM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SELENICEREUS GRANDIFLORUS STEM 30 [hp_C]/1 N 20181231 68428-268_f9e4100b-8b98-4984-a3e7-47e0a6d1685b 68428-268 HUMAN OTC DRUG Cadmium iodatum CADMIUM IODIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CADMIUM IODIDE 30 [hp_C]/1 N 20181231 68428-269_197522cd-2081-46d8-9a9e-9eba04b54cbf 68428-269 HUMAN OTC DRUG Cadmium Sulphuratum CADMIUM SULFIDE PELLET ORAL 20100615 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CADMIUM SULFIDE 30 [hp_C]/1 N 20181231 68428-270_0347836d-d7da-42c7-b6bd-54ec32b2be9e 68428-270 HUMAN OTC DRUG Cadmium Sulphuricum CADMIUM SULFATE PELLET ORAL 20101028 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CADMIUM SULFATE 30 [hp_C]/1 N 20181231 68428-271_6fc3c6f5-af12-4398-9e30-22e0e235f878 68428-271 HUMAN OTC DRUG Caladium Seguinum DIEFFENBACHIA SEGUINE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIEFFENBACHIA SEGUINE 30 [hp_C]/1 N 20181231 68428-272_a66d4a1a-d344-41da-a391-30e95f9ea75f 68428-272 HUMAN OTC DRUG Calcarea arsenicica CALCIUM ARSENATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM ARSENATE 30 [hp_C]/1 N 20181231 68428-273_6e75dc2e-a722-47e7-bdb7-92afffa755a0 68428-273 HUMAN OTC DRUG Calcarea carbonica OYSTER SHELL CALCIUM CARBONATE, CRUDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C]/1 N 20181231 68428-274_3fcfa2d3-3a6a-400d-8521-b7c1f3faaa82 68428-274 HUMAN OTC DRUG Calcarea caustica CALCIUM HYDROXIDE PELLET ORAL 20100729 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM HYDROXIDE 30 [hp_C]/1 N 20181231 68428-275_6a05a6a1-e653-4cbe-8f54-ec24e2c2097d 68428-275 HUMAN OTC DRUG Calcarea fluorica CALCIUM FLUORIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM FLUORIDE 30 [hp_C]/1 N 20181231 68428-276_96eb728b-e7e6-460e-a6c2-f1bd791c8478 68428-276 HUMAN OTC DRUG Calcarea Hypophosphorosa CALCIUM HYPOPHOSPHITE PELLET ORAL 20110121 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM HYPOPHOSPHITE 30 [hp_C]/1 N 20181231 68428-277_0283f373-f58d-402c-9428-06dbddb0d570 68428-277 HUMAN OTC DRUG Calcarea iodata CALCIUM IODIDE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM IODIDE 30 [hp_C]/1 N 20181231 68428-278_a66d64cc-a00a-480d-a726-32f9091ad60b 68428-278 HUMAN OTC DRUG Calcarea phosphorica TRIBASIC CALCIUM PHOSPHATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TRIBASIC CALCIUM PHOSPHATE 30 [hp_C]/1 N 20181231 68428-279_34fe35ab-1f90-41c6-952e-ea37db9a661e 68428-279 HUMAN OTC DRUG Calcarea sulphurica CALCIUM SULFATE ANHYDROUS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM SULFATE ANHYDROUS 30 [hp_C]/1 N 20181231 68428-280_1e506ff1-fb31-46f5-ab00-3ad344d70cfa 68428-280 HUMAN OTC DRUG Calendula officinalis CALENDULA OFFICINALIS FLOWERING TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALENDULA OFFICINALIS FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-281_33dfd23c-8938-4c43-b3ca-bdedfe2f3a55 68428-281 HUMAN OTC DRUG Calotropis gigantea CALOTROPIS GIGANTEA ROOT PELLET ORAL 20100324 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALOTROPIS GIGANTEA ROOT 30 [hp_C]/1 N 20181231 68428-282_1f12dd48-69ac-4d16-bfa4-7c448b6acce9 68428-282 HUMAN OTC DRUG Camphora CAMPHOR (NATURAL) PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAMPHOR (NATURAL) 30 [hp_C]/1 N 20181231 68428-283_3877bc03-0a8a-47bd-8074-ef27c07fdb16 68428-283 HUMAN OTC DRUG Candida albicans CANDIDA ALBICANS PELLET ORAL 20100204 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CANDIDA ALBICANS 30 [hp_C]/1 N 20181231 68428-284_4cdc8558-52bb-4e37-afa7-1d06ed584fbc 68428-284 HUMAN OTC DRUG Cantharis LYTTA VESICATORIA PELLET ORAL 20100202 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYTTA VESICATORIA 30 [hp_C]/1 N 20181231 68428-285_5edb3774-7fc0-4c7a-a2a8-e54a4f6cfe2b 68428-285 HUMAN OTC DRUG Capsicum annuum CAPSICUM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAPSICUM 30 [hp_C]/1 N 20181231 68428-286_7e832a6b-582a-4f2d-9c16-856bbbb312c3 68428-286 HUMAN OTC DRUG Carbo animalis CARBO ANIMALIS PELLET ORAL 20100513 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CARBO ANIMALIS 30 [hp_C]/1 N 20181231 68428-287_bd07320d-3528-4c7b-a8d8-0dcbef06f3d8 68428-287 HUMAN OTC DRUG Carbo vegetabilis ACTIVATED CHARCOAL PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACTIVATED CHARCOAL 30 [hp_C]/1 N 20181231 68428-288_747978cd-ecb7-4afe-9b39-e43005bbea79 68428-288 HUMAN OTC DRUG Carbolicum acidum PHENOL PELLET ORAL 20100401 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHENOL 30 [hp_C]/1 N 20181231 68428-289_bbbec002-efb5-4ca8-9cc7-c5ae7bdb7f9a 68428-289 HUMAN OTC DRUG Carboneum sulphuratum CARBON DISULFIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CARBON DISULFIDE 30 [hp_C]/1 N 20181231 68428-290_44c0c02e-a726-4b81-8da7-092a108a3ab7 68428-290 HUMAN OTC DRUG Cardiospermum CARDIOSPERMUM HALICACABUM FLOWERING TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CARDIOSPERMUM HALICACABUM FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-291_cbc12db7-60a6-4db5-a55b-22d6325ead1c 68428-291 HUMAN OTC DRUG Carduus Mar SILYBUM MARIANUM SEED PELLET ORAL 20100226 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MILK THISTLE 30 [hp_C]/1 N 20181231 68428-292_6e5774ae-2f0e-44a2-ab00-b4a7f7614729 68428-292 HUMAN OTC DRUG Cascarilla CROTON ELUTERIA BARK PELLET ORAL 20101203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CROTON ELUTERIA BARK 30 [hp_C]/1 N 20181231 68428-293_b6a48c34-6374-4919-8cb2-fa91395636b3 68428-293 HUMAN OTC DRUG Castor equi EQUUS CABALLUS LEG CALLOUS PELLET ORAL 20100514 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EQUUS CABALLUS LEG CALLOUS 30 [hp_C]/1 N 20181231 68428-294_df169f37-8aaf-48a1-89eb-466951160dd4 68428-294 HUMAN OTC DRUG Caulophyllum thalictroides CAULOPHYLLUM THALICTROIDES ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAULOPHYLLUM THALICTROIDES ROOT 30 [hp_C]/1 N 20181231 68428-295_d20f4025-7e3a-4503-8a76-a506013bd95d 68428-295 HUMAN OTC DRUG Causticum CAUSTICUM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAUSTICUM 30 [hp_C]/1 N 20181231 68428-296_06bb492f-f531-477d-98d9-d6945424014a 68428-296 HUMAN OTC DRUG Ceanothus americanus CEANOTHUS AMERICANUS LEAF PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CEANOTHUS AMERICANUS LEAF 30 [hp_C]/1 N 20181231 68428-297_9aebec1f-a01b-4c28-9727-f5e687fd580a 68428-297 HUMAN OTC DRUG Cedron SIMABA CEDRON SEED PELLET ORAL 20100415 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SIMABA CEDRON SEED 30 [hp_C]/1 N 20181231 68428-298_88e24b49-d433-43c8-a40a-b137cdc767f8 68428-298 HUMAN OTC DRUG Cenchris contortrix AGKISTRODON CONTORTRIX VENOM PELLET ORAL 20101021 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AGKISTRODON CONTORTRIX VENOM 30 [hp_C]/1 N 20181231 68428-299_e989813a-518e-47f1-a2ef-116a454ca4ac 68428-299 HUMAN OTC DRUG Cereus bonplandii HARRISIA POMANENSIS STEM PELLET ORAL 20101215 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HARRISIA POMANENSIS STEM 30 [hp_C]/1 N 20181231 68428-300_a03b9a7e-a001-4289-8069-5abe8ff34629 68428-300 HUMAN OTC DRUG Chamomilla MATRICARIA RECUTITA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MATRICARIA RECUTITA 30 [hp_C]/1 N 20181231 68428-301_64fa4ce7-5ff3-4eac-9bed-71245cf33366 68428-301 HUMAN OTC DRUG Cheiranthus cheiri ERYSIMUM CHEIRI PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ERYSIMUM CHEIRI 30 [hp_C]/1 N 20181231 68428-302_2a767ff7-c58b-4cc9-b6dc-572cb570bd94 68428-302 HUMAN OTC DRUG Chelidonium majus CHELIDONIUM MAJUS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHELIDONIUM MAJUS 30 [hp_C]/1 N 20181231 68428-303_daa1353a-41cc-43cc-ba7e-3a4d6a458998 68428-303 HUMAN OTC DRUG Chelone glabra CHELONE GLABRA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHELONE GLABRA 30 [hp_C]/1 N 20181231 68428-304_94866c14-c649-457c-bc29-2c69d910255b 68428-304 HUMAN OTC DRUG Chenopodium anthelminticum CHENOPODIUM AMBROSIOIDES PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHENOPODIUM AMBROSIOIDES 30 [hp_C]/1 N 20181231 68428-305_639efc54-64d5-4dfe-8ab6-7170820477c4 68428-305 HUMAN OTC DRUG Chimaphila umbellata CHIMAPHILA UMBELLATA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHIMAPHILA UMBELLATA 30 [hp_C]/1 N 20181231 68428-306_58bd751e-983a-441f-9723-b7ab7cddb476 68428-306 HUMAN OTC DRUG Chininum arsenicicum QUININE ARSENATE PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUININE ARSENATE 30 [hp_C]/1 N 20181231 68428-307_f6b02a42-374a-4e9d-8586-27169adefc1a 68428-307 HUMAN OTC DRUG Chininum arsenicosum QUININE ARSENITE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUININE ARSENITE 30 [hp_C]/1 N 20181231 68428-308_68c8a720-4ed6-4497-84a7-85482e8d69a9 68428-308 HUMAN OTC DRUG Chininum purum QUININE PELLET ORAL 20100204 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUININE 30 [hp_C]/1 N 20181231 68428-309_758da232-f00e-4f0e-aa5b-5631957d1c82 68428-309 HUMAN OTC DRUG Chininum salicylicum QUININE SALICYLATE PELLET ORAL 20100212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUININE SALICYLATE 30 [hp_C]/1 N 20181231 68428-310_ff5a8e90-40dd-4d2e-a9cd-ab222a074935 68428-310 HUMAN OTC DRUG Chininum sulphuricum QUININE SULFATE PELLET ORAL 20100302 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUININE SULFATE 30 [hp_C]/1 N 20181231 68428-311_05db5f32-ac6c-410e-98f7-128fabd3582f 68428-311 HUMAN OTC DRUG Chionanthus virginica CHIONANTHUS VIRGINICUS BARK PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHIONANTHUS VIRGINICUS BARK 30 [hp_C]/1 N 20181231 68428-312_1aa68153-e913-419e-bb84-421e204714b0 68428-312 HUMAN OTC DRUG Chlorinum CHLORINE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHLORINE 30 [hp_C]/1 N 20181231 68428-313_7c1f2b34-e95f-414f-b833-d9e073dd6426 68428-313 HUMAN OTC DRUG Chloroformum CHLOROFORM PELLET ORAL 20110103 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHLOROFORM 30 [hp_C]/1 N 20181231 68428-314_b6a78620-6cbc-4842-95e7-9cce898546af 68428-314 HUMAN OTC DRUG Chlorpromazinum CHLORPROMAZINE PELLET ORAL 20101007 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHLORPROMAZINE 30 [hp_C]/1 N 20181231 68428-315_ef619356-97ac-400b-80d3-347b53273752 68428-315 HUMAN OTC DRUG Cholesterinum CHOLESTEROL PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHOLESTEROL 30 [hp_C]/1 N 20181231 68428-316_d2a5a275-0084-4755-9b48-1e21109ec3e2 68428-316 HUMAN OTC DRUG Chrysarobinum CHRYSAROBIN PELLET ORAL 20110307 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHRYSAROBIN 30 [hp_C]/1 N 20181231 68428-317_6e16c382-c26f-4b12-90a7-ae11082be748 68428-317 HUMAN OTC DRUG Cicuta virosa CICUTA VIROSA ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CICUTA VIROSA ROOT 30 [hp_C]/1 N 20181231 68428-318_fb62c70e-7357-44ed-a04d-72c66d0af3f0 68428-318 HUMAN OTC DRUG Cimicifuga racemosa BLACK COHOSH PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLACK COHOSH 30 [hp_C]/1 N 20181231 68428-319_5f698231-6f3e-415d-bd78-6e8b31b928d2 68428-319 HUMAN OTC DRUG Cina ARTEMISIA CINA PRE-FLOWERING TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARTEMISIA CINA PRE-FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-320_5d8a3520-d327-47a7-9676-a905d83ea6e1 68428-320 HUMAN OTC DRUG Cinchona officinalis CINCHONA OFFICINALIS BARK PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CINCHONA OFFICINALIS BARK 30 [hp_C]/1 N 20181231 68428-321_dbb402d7-c1d4-453e-ad01-533ca2e38378 68428-321 HUMAN OTC DRUG Cineraria maritima JACOBAEA MARITIMA PELLET ORAL 20110207 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products JACOBAEA MARITIMA 30 [hp_C]/1 N 20181231 68428-322_2bf13dba-ea67-44a0-b79c-3bbeae33634b 68428-322 HUMAN OTC DRUG Cinnamomum CINNAMON PELLET ORAL 20110318 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CINNAMON 30 [hp_C]/1 N 20181231 68428-323_bf3f79cc-fafc-4379-8130-8001b23d4489 68428-323 HUMAN OTC DRUG Cistus canadensis HELIANTHEMUM CANADENSE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HELIANTHEMUM CANADENSE 30 [hp_C]/1 N 20181231 68428-324_43e20d07-743d-4648-a784-f326d92ae63d 68428-324 HUMAN OTC DRUG Citrus vulgaris CITRUS AURANTIUM FRUIT RIND PELLET ORAL 20100322 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CITRUS AURANTIUM FRUIT RIND 30 [hp_C]/1 N 20181231 68428-325_b5763a3b-95c3-43b6-8597-b5fe2466ca3a 68428-325 HUMAN OTC DRUG Clematis erecta CLEMATIS RECTA FLOWERING TOP PELLET ORAL 20100305 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CLEMATIS RECTA FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-326_cc4c367f-d4b2-4764-8abd-0cf3e7020ef4 68428-326 HUMAN OTC DRUG Clematis virginiana CLEMATIS VIRGINIANA TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CLEMATIS VIRGINIANA TOP 30 [hp_C]/1 N 20181231 68428-327_88a5a1cf-69b5-4922-a03a-d9c418bcc024 68428-327 HUMAN OTC DRUG Cobaltum metallicum COBALT PELLET ORAL 20100803 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COBALT 30 [hp_C]/1 N 20181231 68428-328_23953f38-1d4f-43bb-bb16-53afdcb16417 68428-328 HUMAN OTC DRUG Coccinella semptempunctata COCCINELLA SEPTEMPUNCTATA PELLET ORAL 20100623 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COCCINELLA SEPTEMPUNCTATA 30 [hp_C]/1 N 20181231 68428-329_77cc5b83-f3fa-4b46-99af-e8864c05d909 68428-329 HUMAN OTC DRUG Cocculus indicus ANAMIRTA COCCULUS SEED PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANAMIRTA COCCULUS SEED 30 [hp_C]/1 N 20181231 68428-330_5876b68f-a0f3-434b-bd0d-a060c0f326fb 68428-330 HUMAN OTC DRUG Coccus cacti PROTORTONIA CACTI PELLET ORAL 20100324 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PROTORTONIA CACTI 30 [hp_C]/1 N 20181231 68428-331_8fd92899-6ded-4891-967b-ac5e0d67e4fa 68428-331 HUMAN OTC DRUG Coffea cruda ARABICA COFFEE BEAN PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARABICA COFFEE BEAN 30 [hp_C]/1 N 20181231 68428-332_6c9427f9-b7c6-4f34-8365-8243ab4b66b0 68428-332 HUMAN OTC DRUG Coffea tosta COFFEA ARABICA SEED, ROASTED PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COFFEA ARABICA SEED, ROASTED 30 [hp_C]/1 N 20181231 68428-333_0ba76b73-8f9a-40ed-b13b-2eb06062f5c7 68428-333 HUMAN OTC DRUG Colchicum autumnale COLCHICUM AUTUMNALE BULB PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COLCHICUM AUTUMNALE BULB 30 [hp_C]/1 N 20181231 68428-334_f0f738f7-13b2-495f-a24e-6a9bf238cd3e 68428-334 HUMAN OTC DRUG Collinsonia canadensis COLLINSONIA CANADENSIS ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COLLINSONIA CANADENSIS ROOT 30 [hp_C]/1 N 20181231 68428-335_fc2232c1-47d1-4b79-8b47-afaeb762bb69 68428-335 HUMAN OTC DRUG Colocynthis CITRULLUS COLOCYNTHIS FRUIT PULP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CITRULLUS COLOCYNTHIS FRUIT PULP 30 [hp_C]/1 N 20181231 68428-336_f11771ca-ecba-4300-8e86-cb06208a8750 68428-336 HUMAN OTC DRUG Comocladia dentata COMOCLADIA DENTATA BARK/LEAF PELLET ORAL 20110112 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COMOCLADIA DENTATA BARK/LEAF 30 [hp_C]/1 N 20181231 68428-337_f7a24ef4-bd26-4e28-9172-5a1fc5076b19 68428-337 HUMAN OTC DRUG Conchiolinum PINCTADA MARGARITIFERA SHELL PELLET ORAL 20100504 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PINCTADA MARGARITIFERA SHELL 30 [hp_C]/1 N 20181231 68428-338_fb5f1c1f-8abb-4834-9655-2a73d28627ac 68428-338 HUMAN OTC DRUG Condurango MARSDENIA CONDURANGO BARK PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MARSDENIA CONDURANGO BARK 30 [hp_C]/1 N 20181231 68428-339_52521ec0-6831-4eab-b826-060a40b8db21 68428-339 HUMAN OTC DRUG Conium maculatum CONIUM MACULATUM FLOWERING TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CONIUM MACULATUM FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-340_8fb7f1ce-e04d-4ee6-84c5-1aad15045c3d 68428-340 HUMAN OTC DRUG Convallaria majalis CONVALLARIA MAJALIS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CONVALLARIA MAJALIS 30 [hp_C]/1 N 20181231 68428-341_318db3cc-14fc-4402-a985-0cca6dec2629 68428-341 HUMAN OTC DRUG Corallium rubrum CORALLIUM RUBRUM EXOSKELETON PELLET ORAL 20110303 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CORALLIUM RUBRUM EXOSKELETON 30 [hp_C]/1 N 20181231 68428-342_7c6153ba-5a70-418b-be7b-c93f3dc55cb8 68428-342 HUMAN OTC DRUG Cornus florida CORNUS FLORIDA BARK PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CORNUS FLORIDA BARK 30 [hp_C]/1 N 20181231 68428-343_8d4948ea-4454-4eae-8557-3b4b8a505378 68428-343 HUMAN OTC DRUG Cortisone aceticum CORTISONE ACETATE PELLET ORAL 20100513 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CORTISONE ACETATE 30 [hp_C]/1 N 20181231 68428-344_e2895ee9-6a80-450c-a01f-69164865ad31 68428-344 HUMAN OTC DRUG Crocus Sativus SAFFRON PELLET ORAL 20100803 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SAFFRON 30 [hp_C]/1 N 20181231 68428-345_ee9d649d-fc70-4924-8379-5ebccd4e54ef 68428-345 HUMAN OTC DRUG Crotalus horridus CROTALUS HORRIDUS HORRIDUS VENOM PELLET ORAL 20100223 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CROTALUS HORRIDUS HORRIDUS VENOM 30 [hp_C]/1 N 20181231 68428-346_d66253d2-059a-47ce-a1b6-adcf3b3db664 68428-346 HUMAN OTC DRUG Croton tiglium CROTON TIGLIUM SEED PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CROTON TIGLIUM SEED 30 [hp_C]/1 N 20181231 68428-347_2685ac6c-aa1a-4082-b914-1b692f64aa79 68428-347 HUMAN OTC DRUG Cucurbita pepo, semen PUMPKIN SEED PELLET ORAL 20100625 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PUMPKIN SEED 30 [hp_C]/1 N 20181231 68428-348_2a6cc10d-ce97-485a-b402-bfafbfd224ac 68428-348 HUMAN OTC DRUG Cuprum arsenicosum CUPRIC ARSENITE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CUPRIC ARSENITE 30 [hp_C]/1 N 20181231 68428-349_751f21b0-5a0c-4b40-8db6-e22342839487 68428-349 HUMAN OTC DRUG Cuprum metallicum COPPER PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COPPER 30 [hp_C]/1 N 20181231 68428-350_945980f6-7822-4210-8822-fff13c5f7005 68428-350 HUMAN OTC DRUG Cuprum oxydatum nigrum CUPRIC OXIDE PELLET ORAL 20101202 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CUPRIC OXIDE 30 [hp_C]/1 N 20181231 68428-351_58b4f621-bece-43f7-b4fe-bc140932ba87 68428-351 HUMAN OTC DRUG Cuprum sulphuricum CUPRIC SULFATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CUPRIC SULFATE 30 [hp_C]/1 N 20181231 68428-352_782d0a54-36e2-4709-9574-025a7fc7c6d0 68428-352 HUMAN OTC DRUG Curare TUBOCURARINE CHLORIDE PELLET ORAL 20100513 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TUBOCURARINE CHLORIDE 30 [hp_C]/1 N 20181231 68428-353_07a7685b-039a-4053-9911-e95a2832f106 68428-353 HUMAN OTC DRUG Cyclamen europaeum CYCLAMEN PURPURASCENS TUBER PELLET ORAL 20100419 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CYCLAMEN PURPURASCENS TUBER 30 [hp_C]/1 N 20181231 68428-354_65583b7b-f93d-4122-8c5f-1b34660a1688 68428-354 HUMAN OTC DRUG Cypripedium pubescens CYPRIPEDIUM PARVIFOLUM ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic 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Elaps corallinus MICRURUS CORALLINUS VENOM PELLET ORAL 20101019 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MICRURUS CORALLINUS VENOM 30 [hp_C]/1 N 20181231 68428-364_520258d7-839d-437d-a886-8584cb1d1768 68428-364 HUMAN OTC DRUG Ephedra vulgaris EPHEDRA DISTACHYA FLOWERING TWIG PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EPHEDRA DISTACHYA FLOWERING TWIG 30 [hp_C]/1 N 20181231 68428-365_543fa904-8ae7-4697-a7ac-956e6d111f0e 68428-365 HUMAN OTC DRUG Epigaea repens EPIGAEA REPENS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EPIGAEA REPENS 30 [hp_C]/1 N 20181231 68428-366_be63f4c7-ca81-4951-b54e-2ab6306ab00b 68428-366 HUMAN OTC DRUG Epiphegus virginiana EPIFAGUS VIRGINIANA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EPIFAGUS VIRGINIANA 30 [hp_C]/1 N 20181231 68428-367_4bf2fed4-7c23-4ab8-a658-11bd388417d4 68428-367 HUMAN OTC DRUG Equisetum arvense EQUISETUM ARVENSE TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EQUISETUM ARVENSE TOP 30 [hp_C]/1 N 20181231 68428-368_51b09e3a-6c1a-4a15-9d71-b998a57197c8 68428-368 HUMAN OTC DRUG Equisetum hyemale EQUISETUM HYEMALE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EQUISETUM HYEMALE 30 [hp_C]/1 N 20181231 68428-369_70a3d20d-d77d-4e09-81b7-609cf8cd0fc0 68428-369 HUMAN OTC DRUG Erigeron canadensis ERIGERON CANADENSIS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ERIGERON CANADENSIS 30 [hp_C]/1 N 20181231 68428-370_286f386f-95ed-439f-a475-98ad7fd4a0e0 68428-370 HUMAN OTC DRUG Eriodictyon californicum ERIODICTYON CALIFORNICUM LEAF PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ERIODICTYON CALIFORNICUM LEAF 30 [hp_C]/1 N 20181231 68428-371_f228e62b-fa51-4829-85cc-5ddbf4d1bdeb 68428-371 HUMAN OTC DRUG Eryngium aquaticum ERYNGIUM YUCCIFOLIUM ROOT PELLET ORAL 20101029 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ERYNGIUM YUCCIFOLIUM ROOT 30 [hp_C]/1 N 20181231 68428-372_2f605071-44f5-46b3-8ce1-a7fc86f83013 68428-372 HUMAN OTC DRUG Eschscholtzia californica ESCHSCHOLZIA CALIFORNICA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ESCHSCHOLZIA CALIFORNICA 30 [hp_C]/1 N 20181231 68428-373_0f3f9437-8209-45c0-9c67-c9286ec0dcf1 68428-373 HUMAN OTC DRUG Eucalyptus globulus EUCALYPTUS GLOBULUS LEAF PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUCALYPTUS GLOBULUS LEAF 30 [hp_C]/1 N 20181231 68428-374_d1f7fb29-2e1a-47ca-82b1-979bc30b575b 68428-374 HUMAN OTC DRUG Eugenia jambosa SYZYGIUM JAMBOS SEED PELLET ORAL 20101207 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SYZYGIUM JAMBOS SEED 30 [hp_C]/1 N 20181231 68428-375_fcf63d3c-3a02-4441-bacd-18ada0422f5f 68428-375 HUMAN OTC DRUG Euonymus atropurpureus EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK PELLET ORAL 20100816 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK 30 [hp_C]/1 N 20181231 68428-376_f276bb92-a5c0-4f8f-861e-7a91c93cd605 68428-376 HUMAN OTC DRUG Eupatorium perfoliatum EUPATORIUM PERFOLIATUM FLOWERING TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPATORIUM PERFOLIATUM FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-377_b4702f0b-6753-452d-9e00-59688d3ffe0b 68428-377 HUMAN OTC DRUG Euphrasia officinalis EUPHRASIA STRICTA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPHRASIA STRICTA 30 [hp_C]/1 N 20181231 68428-378_9be4cac4-3fbe-45a8-95b0-e9bef4fa0990 68428-378 HUMAN OTC DRUG Fagopyrum esculentum FAGOPYRUM ESCULENTUM PELLET ORAL 20101029 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FAGOPYRUM ESCULENTUM 30 [hp_C]/1 N 20181231 68428-379_a76e2748-e1b1-46ac-9331-7512f08e58a8 68428-379 HUMAN OTC DRUG Fel tauri BOS TAURUS BILE PELLET ORAL 20100629 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BOS TAURUS BILE 30 [hp_C]/1 N 20181231 68428-380_3243db5d-07a7-4bab-b156-11fad97bc7e5 68428-380 HUMAN OTC DRUG Ferrum arsenicicum FERROUS ARSENATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERROUS ARSENATE 30 [hp_C]/1 N 20181231 68428-381_bf519db2-d779-4688-a118-25618d52a8db 68428-381 HUMAN OTC DRUG Ferrum carbonicum FERROUS CARBONATE PELLET ORAL 20110511 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERROUS CARBONATE 30 [hp_C]/1 N 20181231 68428-382_4c388a52-8630-49c6-86cb-be5952f265a1 68428-382 HUMAN OTC DRUG Ferrum iodatum FERROUS IODIDE PELLET ORAL 20100729 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERROUS IODIDE 30 [hp_C]/1 N 20181231 68428-383_552a291c-8260-48f4-a5a9-3f9968cc768a 68428-383 HUMAN OTC DRUG Ferrum metallicum IRON PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IRON 30 [hp_C]/1 N 20181231 68428-384_d1d62764-84f5-4091-9c87-22fbdb6176d3 68428-384 HUMAN OTC DRUG Ferrum muriaticum FERRIC CHLORIDE HEXAHYDRATE PELLET ORAL 20100419 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERRIC CHLORIDE HEXAHYDRATE 30 [hp_C]/1 N 20181231 68428-385_8d4cdc83-af7e-4d89-9303-77728e6e2cf6 68428-385 HUMAN OTC DRUG Ferrum phosphoricum FERROSOFERRIC PHOSPHATE PELLET ORAL 20100319 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERROSOFERRIC PHOSPHATE 30 [hp_C]/1 N 20181231 68428-386_08aba5e0-1efb-4cac-b271-092cf1e5fd14 68428-386 HUMAN OTC DRUG Ferrum picricum FERRIC PICRATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERRIC PICRATE 30 [hp_C]/1 N 20181231 68428-387_f6a4f723-1191-48a5-a834-4128140f024e 68428-387 HUMAN OTC DRUG Ficus religiosa FICUS RELIGIOSA LEAFY TWIG PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FICUS RELIGIOSA LEAFY TWIG 30 [hp_C]/1 N 20181231 68428-388_2c2c8ae4-3009-4ec8-b420-b0b3b1de1745 68428-388 HUMAN OTC DRUG Filix mas DRYOPTERIS FILIX-MAS ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DRYOPTERIS FILIX-MAS ROOT 30 [hp_C]/1 N 20181231 68428-389_77af8337-6a8f-4493-b54e-69baf05e192d 68428-389 HUMAN OTC DRUG Folliculinum ESTRONE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ESTRONE 30 [hp_C]/1 N 20181231 68428-390_9b17c313-8fd4-42b4-a0ec-e964399b117b 68428-390 HUMAN OTC DRUG Formalinum FORMALDEHYDE PELLET ORAL 20101208 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FORMALDEHYDE 30 [hp_C]/1 N 20181231 68428-391_ec0b3629-cb0f-45c9-986e-aa7befbf0e59 68428-391 HUMAN OTC DRUG Formica rufa FORMICA RUFA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FORMICA RUFA 30 [hp_C]/1 N 20181231 68428-392_ecae6cf1-7408-4e82-9055-04c7981f2af5 68428-392 HUMAN OTC DRUG Formicum acidum FORMIC ACID PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FORMIC ACID 30 [hp_C]/1 N 20181231 68428-393_94713d5d-3592-45be-8e4a-ba2a265206c2 68428-393 HUMAN OTC DRUG Fragaria vesca ALPINE STRAWBERRY PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALPINE STRAWBERRY 30 [hp_C]/1 N 20181231 68428-394_4d9ac173-3b0e-428d-af0d-fa1106fc66bc 68428-394 HUMAN OTC DRUG Fraxinus americana FRAXINUS AMERICANA BARK PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FRAXINUS AMERICANA BARK 30 [hp_C]/1 N 20181231 68428-395_b6d09a16-3e5a-42a8-a0ed-22ad1f556a0c 68428-395 HUMAN OTC DRUG Galanthus nivalis GALANTHUS NIVALIS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GALANTHUS NIVALIS 30 [hp_C]/1 N 20181231 68428-396_344382c6-906a-4722-975a-057b963c2aa0 68428-396 HUMAN OTC DRUG Galega officinalis GALEGA OFFICINALIS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GALEGA OFFICINALIS 30 [hp_C]/1 N 20181231 68428-397_2bf7f05d-e217-4ea5-a51b-c4c397127a28 68428-397 HUMAN OTC DRUG Galium aparine GALIUM APARINE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GALIUM APARINE 30 [hp_C]/1 N 20181231 68428-398_cb3f568a-c4eb-4ee1-9636-2dacc3f14cc1 68428-398 HUMAN OTC DRUG Gallicum acidum Ac GALLIC ACID MONOHYDRATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GALLIC ACID MONOHYDRATE 30 [hp_C]/1 N 20181231 68428-399_35ee0f2d-4cc0-4b22-86fd-4f96492a95f7 68428-399 HUMAN OTC DRUG Galphimia glauca GALPHIMIA GLAUCA FLOWERING TOP PELLET ORAL 20100215 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GALPHIMIA GLAUCA FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-400_ebfaa098-2f23-455e-9079-b10e7806d50b 68428-400 HUMAN OTC DRUG Gambogia GAMBOGE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GAMBOGE 30 [hp_C]/1 N 20181231 68428-401_77e15771-b48b-4810-9fc5-3674ed0ef741 68428-401 HUMAN OTC DRUG Gaultheria procumbens GAULTHERIA PROCUMBENS TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GAULTHERIA PROCUMBENS TOP 30 [hp_C]/1 N 20181231 68428-402_bb30478e-08cf-4bcd-b091-15417f3a308e 68428-402 HUMAN OTC DRUG Gelsemium sempervirens GELSEMIUM SEMPERVIRENS ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GELSEMIUM SEMPERVIRENS ROOT 30 [hp_C]/1 N 20181231 68428-403_a83b3d74-4b3e-4492-b9bd-c591e6621d25 68428-403 HUMAN OTC DRUG Gentiana cruciata GENTIANA CRUCIATA ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GENTIANA CRUCIATA ROOT 30 [hp_C]/1 N 20181231 68428-404_c2c588eb-94bf-4930-a270-d3f2a1ae4d8a 68428-404 HUMAN OTC DRUG Geranium maculatum GERANIUM MACULATUM ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GERANIUM MACULATUM ROOT 30 [hp_C]/1 N 20181231 68428-405_88c5aaf2-9bd8-4e57-b5c1-b2ece5a0d572 68428-405 HUMAN OTC DRUG Geranium robertianum GERANIUM ROBERTIANUM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GERANIUM ROBERTIANUM 30 [hp_C]/1 N 20181231 68428-406_f1c39f60-4c26-483c-af58-71e9faf7ae3b 68428-406 HUMAN OTC DRUG Ginkgo biloba GINKGO PELLET ORAL 20091210 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GINKGO 30 [hp_C]/1 N 20181231 68428-407_5d918f19-89e4-48b6-bada-361f2bed9b9a 68428-407 HUMAN OTC DRUG Glonoinum NITROGLYCERIN PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NITROGLYCERIN 30 [hp_C]/1 N 20181231 68428-408_994275f6-289f-4599-af81-9a450d318575 68428-408 HUMAN OTC DRUG Glycerinum GLYCERIN PELLET ORAL 20100325 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GLYCERIN 30 [hp_C]/1 N 20181231 68428-409_c1b1f997-444c-4e2b-ae5e-59f49a5aa877 68428-409 HUMAN OTC DRUG Gnaphalium polycephalum PSEUDOGNAPHALIUM OBTUSIFOLIUM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PSEUDOGNAPHALIUM OBTUSIFOLIUM 30 [hp_C]/1 N 20181231 68428-410_43cb4c39-de8d-415d-b152-647dfc4ed086 68428-410 HUMAN OTC DRUG Gossypium herbaceum GOSSYPIUM HERBACEUM ROOT BARK PELLET ORAL 20110110 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GOSSYPIUM HERBACEUM ROOT BARK 30 [hp_C]/1 N 20181231 68428-411_1971f40a-df3c-406a-8181-c45262a1bb30 68428-411 HUMAN OTC DRUG Granatum PUNICA GRANATUM ROOT BARK PELLET ORAL 20101112 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PUNICA GRANATUM ROOT BARK 30 [hp_C]/1 N 20181231 68428-412_ff467c5b-1c76-4146-b3cb-81cf76c0145a 68428-412 HUMAN OTC DRUG Graphites GRAPHITE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GRAPHITE 30 [hp_C]/1 N 20181231 68428-413_263ac2cc-529a-4120-8b9b-9e05a0896a40 68428-413 HUMAN OTC DRUG Grindelia GRINDELIA SQUARROSA FLOWERING TOP PELLET ORAL 20100623 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GRINDELIA SQUARROSA FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-414_74e21053-0aa4-4c01-9fd7-26d1e976167c 68428-414 HUMAN OTC DRUG Guaco MIKANIA PARVIFLORA LEAF PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MIKANIA PARVIFLORA LEAF 30 [hp_C]/1 N 20181231 68428-415_eeab0762-b50d-4a76-8f87-e8991c466573 68428-415 HUMAN OTC DRUG Guaiacum GUAIACUM OFFICINALE RESIN PELLET ORAL 20100401 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GUAIACUM OFFICINALE RESIN 30 [hp_C]/1 N 20181231 68428-416_52bbeaa9-86dc-4d83-958b-8300e7709c70 68428-416 HUMAN OTC DRUG Guarea trichilioides GUAREA GUIDONIA BARK PELLET ORAL 20101013 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GUAREA GUIDONIA BARK 30 [hp_C]/1 N 20181231 68428-417_9704c1ae-2220-4f70-9812-d66ee4f15ac4 68428-417 HUMAN OTC DRUG Gunpowder ACTIVATED CHARCOAL, SULFUR, POTASSIUM NITRATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACTIVATED CHARCOAL; SULFUR; POTASSIUM NITRATE 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-418_8f78bf2c-bd80-491f-b87f-9d9f4bf31899 68428-418 HUMAN OTC DRUG Hamamelis virginiana HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 30 [hp_C]/1 N 20181231 68428-419_91cd3644-19c2-4385-894a-793bb371ad00 68428-419 HUMAN OTC DRUG Hedeoma pulegioides HEDEOMA PULEGIOIDES PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HEDEOMA PULEGIOIDES 30 [hp_C]/1 N 20181231 68428-420_47ddec5d-5bdf-4b43-a6e8-e9f63ba535d9 68428-420 HUMAN OTC DRUG Hedera helix HEDERA HELIX FLOWERING TWIG PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HEDERA HELIX FLOWERING TWIG 30 [hp_C]/1 N 20181231 68428-421_4c043913-8c85-414d-b704-451c6d10a467 68428-421 HUMAN OTC DRUG Hekla lava HEKLA LAVA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HEKLA LAVA 30 [hp_C]/1 N 20181231 68428-422_37e899e0-3213-4daf-9036-746849351279 68428-422 HUMAN OTC DRUG Helleborus niger HELLEBORUS NIGER ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HELLEBORUS NIGER ROOT 30 [hp_C]/1 N 20181231 68428-423_1821a618-1845-4596-b8ad-eaee6c10736a 68428-423 HUMAN OTC DRUG Helonias dioica CHAMAELIRIUM LUTEUM ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHAMAELIRIUM LUTEUM ROOT 30 [hp_C]/1 N 20181231 68428-424_694afcae-610b-4ea3-a2d0-583092b7c035 68428-424 HUMAN OTC DRUG Hepar sulphuris calcareum CALCIUM SULFIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM SULFIDE 30 [hp_C]/1 N 20181231 68428-425_3f881f9f-a5ac-4bd3-bc77-33bd812dadf3 68428-425 HUMAN OTC DRUG Hepatica triloba HEPATICA NOBILIS VAR. OBTUSA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HEPATICA NOBILIS VAR. OBTUSA 30 [hp_C]/1 N 20181231 68428-426_57d9fa73-3ea2-40b7-93de-79ac422f89e9 68428-426 HUMAN OTC DRUG Histaminum hydrocloricum HISTAMINE DIHYDROCHLORIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HISTAMINE DIHYDROCHLORIDE 30 [hp_C]/1 N 20181231 68428-427_2a4dd097-754e-4836-9d02-9cd95d672e48 68428-427 HUMAN OTC DRUG Hydrangea arborescens HYDRANGEA ARBORESCENS ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HYDRANGEA ARBORESCENS ROOT 30 [hp_C]/1 N 20181231 68428-428_09650fc1-9f17-4b9a-a44d-3ad5466a3c34 68428-428 HUMAN OTC DRUG Hydrastis canadensis GOLDENSEAL PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GOLDENSEAL 30 [hp_C]/1 N 20181231 68428-429_39312a9a-588a-45ed-b4fb-9a881adaf942 68428-429 HUMAN OTC DRUG Hydrocotyle asiatica CENTELLA ASIATICA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CENTELLA ASIATICA 30 [hp_C]/1 N 20181231 68428-430_b38d4fc0-603c-4fe6-94fe-975fd62b0b19 68428-430 HUMAN OTC DRUG Hydrofluoricum acidum HYDROFLUORIC ACID PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HYDROFLUORIC ACID 30 [hp_C]/1 N 20181231 68428-431_909c55e7-ac2a-4412-baa6-0cc930afd16c 68428-431 HUMAN OTC DRUG Hyoscyamus niger HYOSCYAMUS NIGER PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HYOSCYAMUS NIGER 30 [hp_C]/1 N 20181231 68428-432_e41eec77-81ba-4e52-9ad7-68f72594a451 68428-432 HUMAN OTC DRUG Hypericum perforatum HYPERICUM PERFORATUM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HYPERICUM PERFORATUM 30 [hp_C]/1 N 20181231 68428-433_9f6d835f-1c0b-48ec-a53e-86683089ce01 68428-433 HUMAN OTC DRUG Hypothalamus BOS TAURUS HYPOTHALAMUS PELLET ORAL 20100226 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BOS TAURUS HYPOTHALAMUS 30 [hp_C]/1 N 20181231 68428-434_341c1072-265e-4003-8a6c-997b7278577f 68428-434 HUMAN OTC DRUG Iberis amara IBERIS AMARA SEED PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IBERIS AMARA SEED 30 [hp_C]/1 N 20181231 68428-435_349db21a-30ff-4c3a-8841-e3c2d5767f75 68428-435 HUMAN OTC DRUG Ignatia amara STRYCHNOS IGNATII SEED PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STRYCHNOS IGNATII SEED 30 [hp_C]/1 N 20181231 68428-436_d7def96c-844b-4ce9-8f65-ec9253c64a1a 68428-436 HUMAN OTC DRUG Ilex aquifolium ILEX AQUIFOLIUM FRUITING TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ILEX AQUIFOLIUM FRUITING TOP 30 [hp_C]/1 N 20181231 68428-437_71b32a7b-7829-4bbf-a303-d6460861028d 68428-437 HUMAN OTC DRUG Illicium anisatum STAR ANISE PELLET ORAL 20100204 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STAR ANISE 30 [hp_C]/1 N 20181231 68428-439_41169391-bef8-46ab-a1c5-4118a2cbc970 68428-439 HUMAN OTC DRUG Inula helenium INULA HELENIUM ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products INULA HELENIUM ROOT 30 [hp_C]/1 N 20181231 68428-440_9c419a80-d0da-4316-a559-24c8899a0728 68428-440 HUMAN OTC DRUG Iodium IODINE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IODINE 30 [hp_C]/1 N 20181231 68428-441_9469a4c9-4129-4ce7-8e9a-edc83edfc51b 68428-441 HUMAN OTC DRUG Ipecacuanha IPECAC PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IPECAC 30 [hp_C]/1 N 20181231 68428-442_ef498851-9c78-44f4-9c2e-016928a67716 68428-442 HUMAN OTC DRUG Iridium metallicum IRIDIUM PELLET ORAL 20100326 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IRIDIUM 30 [hp_C]/1 N 20181231 68428-443_090b6b5a-6779-4ab7-943d-d82736b79e27 68428-443 HUMAN OTC DRUG Iris versicolor IRIS VERSICOLOR ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IRIS VERSICOLOR ROOT 30 [hp_C]/1 N 20181231 68428-444_e713c963-5225-42c7-97d8-448ad9e4b749 68428-444 HUMAN OTC DRUG Jonesia asoca SARACA INDICA BARK PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SARACA INDICA BARK 30 [hp_C]/1 N 20181231 68428-445_9bea59ef-af62-4c72-9b24-f3f0e1192df0 68428-445 HUMAN OTC DRUG Juglans cinerea JUGLANS CINEREA BRANCH BARK/ROOT BARK PELLET ORAL 20100419 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products JUGLANS CINEREA BRANCH BARK/ROOT BARK 30 [hp_C]/1 N 20181231 68428-446_437a0ef9-e3d1-429f-93b5-ee06315d53b9 68428-446 HUMAN OTC DRUG Juglans regia JUGLANS REGIA FRUIT RIND, IMMATURE, JUGLANS REGIA LEAF PELLET ORAL 20100401 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF 30; 30 [hp_C]/1; [hp_C]/1 N 20181231 68428-447_1f581135-27ae-4edd-95ff-0a882bb5fbd5 68428-447 HUMAN OTC DRUG Juniperus virginiana JUNIPERUS VIRGINIANA TWIG PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products JUNIPERUS VIRGINIANA TWIG 30 [hp_C]/1 N 20181231 68428-448_88cdb082-b7bc-4ac7-9393-2ce962b939e7 68428-448 HUMAN OTC DRUG Kali arsenicosum POTASSIUM ARSENITE ANHYDROUS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM ARSENITE ANHYDROUS 30 [hp_C]/1 N 20181231 68428-449_04aafa1f-ef69-46dc-bd1a-2c60cbeac18c 68428-449 HUMAN OTC DRUG Kali bichromicum POTASSIUM DICHROMATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM DICHROMATE 30 [hp_C]/1 N 20181231 68428-450_bfae698f-3593-473d-8403-48f5db63859d 68428-450 HUMAN OTC DRUG Kali bromatum POTASSIUM BROMIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM BROMIDE 30 [hp_C]/1 N 20181231 68428-451_3e73249e-c2b2-4fe6-aaec-648f9d59e883 68428-451 HUMAN OTC DRUG Kali carbonicum POTASSIUM CARBONATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM CARBONATE 30 [hp_C]/1 N 20181231 68428-452_d6a931df-7188-46ea-b4f5-1b3260011b8a 68428-452 HUMAN OTC DRUG Kali chloricum POTASSIUM CHLORATE PELLET ORAL 20101021 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM CHLORATE 30 [hp_C]/1 N 20181231 68428-453_cc73202e-d830-4fcd-8ab1-18ade73e7e0e 68428-453 HUMAN OTC DRUG Kali iodatum POTASSIUM IODIDE PELLET ORAL 20101021 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM IODIDE 30 [hp_C]/1 N 20181231 68428-454_957aa558-ef48-4b10-8922-70b2fad5b862 68428-454 HUMAN OTC DRUG Kali muriaticum POTASSIUM CHLORIDE PELLET ORAL 20101021 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM CHLORIDE 30 [hp_C]/1 N 20181231 68428-455_fe3ea29c-8350-4a39-87b7-c33e0ee2ec87 68428-455 HUMAN OTC DRUG Kali nitricum POTASSIUM NITRATE PELLET ORAL 20101029 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM NITRATE 30 [hp_C]/1 N 20181231 68428-456_127b279d-1e30-40d1-90d7-817be0980306 68428-456 HUMAN OTC DRUG Kali phosphoricum DIBASIC POTASSIUM PHOSPHATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIBASIC POTASSIUM PHOSPHATE 30 [hp_C]/1 N 20181231 68428-457_b0370a07-acaf-4474-8de7-2ada1762cc9b 68428-457 HUMAN OTC DRUG Kali sulphuricum POTASSIUM SULFATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM SULFATE 30 [hp_C]/1 N 20181231 68428-458_abe70f70-dc13-48cb-b090-0503a1cf2513 68428-458 HUMAN OTC DRUG Kalmia latifolia KALMIA LATIFOLIA LEAF PELLET ORAL 20100611 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products KALMIA LATIFOLIA LEAF 30 [hp_C]/1 N 20181231 68428-459_448f821a-4353-414f-b11c-e2a38c7838bd 68428-459 HUMAN OTC DRUG Kamala KAMALA PELLET ORAL 20100716 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products KAMALA 30 [hp_C]/1 N 20181231 68428-460_f27d5e78-5fb5-4b36-bfac-80cef9db34bd 68428-460 HUMAN OTC DRUG Kousso HAGENIA ABYSSINICA FLOWER PELLET ORAL 20100315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HAGENIA ABYSSINICA FLOWER 30 [hp_C]/1 N 20181231 68428-461_36907789-6c4c-4311-8c63-67409126a0e3 68428-461 HUMAN OTC DRUG Kreosotum WOOD CREOSOTE PELLET ORAL 20100212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products WOOD CREOSOTE 30 [hp_C]/1 N 20181231 68428-462_7d573d18-6eb7-4dac-b693-ea7e8b67abce 68428-462 HUMAN OTC DRUG Lac caninum CANIS LUPUS FAMILIARIS MILK PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CANIS LUPUS FAMILIARIS MILK 30 [hp_C]/1 N 20181231 68428-463_4cb575e5-8e0c-4ab4-a38f-eb6999262bc5 68428-463 HUMAN OTC DRUG Lac defloratum SKIM MILK PELLET ORAL 20101202 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SKIM MILK 30 [hp_C]/1 N 20181231 68428-464_7d512caa-81d0-4637-9e56-79d2f7c8e70f 68428-464 HUMAN OTC DRUG Lachesis mutus LACHESIS MUTA VENOM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACHESIS MUTA VENOM 30 [hp_C]/1 N 20181231 68428-465_c161593f-05eb-4007-9c0d-350285f0929b 68428-465 HUMAN OTC DRUG Lachnanthes tinctoria LACHNANTHES CAROLINIANA PELLET ORAL 20100803 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACHNANTHES CAROLINIANA 30 [hp_C]/1 N 20181231 68428-466_907ea1a6-008f-4587-aef6-2442b8af419f 68428-466 HUMAN OTC DRUG Lacticum acidum LACTIC ACID, DL- PELLET ORAL 20100324 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACTIC ACID, DL- 30 [hp_C]/1 N 20181231 68428-467_9f620c37-1034-4f4a-9d70-386dcf5bec09 68428-467 HUMAN OTC DRUG Lactuca virosa LACTUCA VIROSA PELLET ORAL 20100521 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACTUCA VIROSA 30 [hp_C]/1 N 20181231 68428-468_15a7109a-18b7-479e-8278-49b00b63e68e 68428-468 HUMAN OTC DRUG Lapis albus CALCIUM HEXAFLUOROSILICATE PELLET ORAL 20100514 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM HEXAFLUOROSILICATE 30 [hp_C]/1 N 20181231 68428-469_c6945314-91b3-4fde-902d-4bdb25c6eb14 68428-469 HUMAN OTC DRUG Lappa major ARCTIUM LAPPA ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARCTIUM LAPPA ROOT 30 [hp_C]/1 N 20181231 68428-470_2cc769b0-d168-4461-a2f3-72c7f9898cee 68428-470 HUMAN OTC DRUG Lathyrus sativus LATHYRUS SATIVAS SEED PELLET ORAL 20101119 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LATHYRUS SATIVAS SEED 30 [hp_C]/1 N 20181231 68428-471_2aef9bdf-cf83-4bc2-af5f-a511dda7f5db 68428-471 HUMAN OTC DRUG Latrodectus mactans LATRODECTUS MACTANS PELLET ORAL 20100412 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LATRODECTUS MACTANS 30 [hp_C]/1 N 20181231 68428-472_fc93d269-5fd6-45df-8c02-4e06842b0b77 68428-472 HUMAN OTC DRUG Lecithin EGG PHOSPHOLIPIDS PELLET ORAL 20100922 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EGG PHOSPHOLIPIDS 30 [hp_C]/1 N 20181231 68428-473_14c01e59-573f-465d-9760-ac4f39165ac4 68428-473 HUMAN OTC DRUG Ledum palustre LEDUM PALUSTRE TWIG PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEDUM PALUSTRE TWIG 30 [hp_C]/1 N 20181231 68428-474_529e7012-1606-4087-97cc-c614c5d76172 68428-474 HUMAN OTC DRUG Leonurus cardiaca LEONURUS CARDIACA PELLET ORAL 20100312 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEONURUS CARDIACA 30 [hp_C]/1 N 20181231 68428-475_4146dd6d-b88f-4e62-a2fe-604dfa9891c7 68428-475 HUMAN OTC DRUG Lepidium bonariense LEPIDIUM DIDYMUM LEAF PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEPIDIUM DIDYMUM LEAF 30 [hp_C]/1 N 20181231 68428-476_79e10510-71d3-42a3-9440-6e324ae435dd 68428-476 HUMAN OTC DRUG Leptandra virginica VERONICASTRUM VIRGINICUM ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VERONICASTRUM VIRGINICUM ROOT 30 [hp_C]/1 N 20181231 68428-477_cf77d58b-0546-4ee3-9a13-3e3719fe5a24 68428-477 HUMAN OTC DRUG Lespedeza capitata LESPEDEZA CAPITATA FLOWERING TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LESPEDEZA CAPITATA FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-478_0d19b2cd-0dd4-47ec-a13d-e60d0eab9ced 68428-478 HUMAN OTC DRUG Levisticum officinale LEVISTICUM OFFICINALE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEVISTICUM OFFICINALE 30 [hp_C]/1 N 20181231 68428-479_5442b161-3682-4458-92a1-79bf59560e00 68428-479 HUMAN OTC DRUG Lilium tigrinum LILIUM LANCIFOLIUM BULB PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LILIUM LANCIFOLIUM BULB 30 [hp_C]/1 N 20181231 68428-480_e665f122-1cb4-492b-9508-753025cb6f11 68428-480 HUMAN OTC DRUG Limulus LIMULUS POLYPHEMUS PELLET ORAL 20101101 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LIMULUS POLYPHEMUS 30 [hp_C]/1 N 20181231 68428-481_2dd2e374-8f2c-4db0-8435-06e23f4fa31a 68428-481 HUMAN OTC DRUG Lithium carbonicum LITHIUM CARBONATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LITHIUM CARBONATE 30 [hp_C]/1 N 20181231 68428-482_9fd813c2-1f24-4192-866f-980f6794eef3 68428-482 HUMAN OTC DRUG Lobelia inflata LOBELIA INFLATA PELLET ORAL 20100806 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LOBELIA INFLATA 30 [hp_C]/1 N 20181231 68428-483_f9d9fafb-106a-49ea-8b0f-8c50f48b4c59 68428-483 HUMAN OTC DRUG Lophophytum leandri LOPHOPHYTUM LEANDRII PELLET ORAL 20101129 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LOPHOPHYTUM LEANDRII 30 [hp_C]/1 N 20181231 68428-484_1c92feaf-81d8-40e9-b0d6-1cdaf5175b92 68428-484 HUMAN OTC DRUG Luffa operculata LUFFA OPERCULATA FRUIT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LUFFA OPERCULATA FRUIT 30 [hp_C]/1 N 20181231 68428-485_0c5e0720-548f-4448-a7e9-7fb1d7ea14a0 68428-485 HUMAN OTC DRUG Lycopodium clavatum LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/1 N 20181231 68428-486_ebd22f37-a6a8-4c21-8eac-53990f703d58 68428-486 HUMAN OTC DRUG Lycopus virginicus LYCOPUS VIRGINICUS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYCOPUS VIRGINICUS 30 [hp_C]/1 N 20181231 68428-487_3516206f-884d-4ad9-85e9-d58ff406f099 68428-487 HUMAN OTC DRUG Magnesia carbonica MAGNESIUM CARBONATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MAGNESIUM CARBONATE 30 [hp_C]/1 N 20181231 68428-488_a1dba0ec-f738-4743-8502-f90dd40ec33f 68428-488 HUMAN OTC DRUG Magnesia muriatica MAGNESIUM CHLORIDE PELLET ORAL 20100729 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MAGNESIUM CHLORIDE 30 [hp_C]/1 N 20181231 68428-489_7a952817-3e7e-41e9-b6c4-0adb43f15e5a 68428-489 HUMAN OTC DRUG Magnesia phosphorica MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 30 [hp_C]/1 N 20181231 68428-490_6ece5142-a271-4479-b1c9-5de5fd0198e1 68428-490 HUMAN OTC DRUG Mancinella HIPPOMANE MANCINELLA FRUITING LEAFY TWIG PELLET ORAL 20101027 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HIPPOMANE MANCINELLA FRUITING LEAFY TWIG 30 [hp_C]/1 N 20181231 68428-491_4b76c5d9-cafe-4814-bae3-3d74b81a758b 68428-491 HUMAN OTC DRUG Mandragora officinarum MANDRAGORA OFFICINARUM ROOT PELLET ORAL 20100203 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[hp_C]/1 N 20181231 68428-496_66719fe8-41e5-43b8-8cf7-6c3574c056cb 68428-496 HUMAN OTC DRUG Melilotus alba MELILOTUS OFFICINALIS TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MELILOTUS OFFICINALIS TOP 30 [hp_C]/1 N 20181231 68428-497_c22c6cd4-e4be-4d1a-b847-a9d9f20a7cf7 68428-497 HUMAN OTC DRUG Melilotus officinalis MELILOTUS OFFICINALIS TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MELILOTUS OFFICINALIS TOP 30 [hp_C]/1 N 20181231 68428-498_094e556c-32e5-4edd-8709-fbd0ca979882 68428-498 HUMAN OTC DRUG Melissa officinalis MELISSA OFFICINALIS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MELISSA OFFICINALIS 30 [hp_C]/1 N 20181231 68428-499_53f9f740-878c-4229-a96a-63e0f63775e9 68428-499 HUMAN OTC DRUG Mentha piperita MENTHA PIPERITA PELLET ORAL 20110302 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MENTHA PIPERITA 30 [hp_C]/1 N 20181231 68428-500_7a62fd02-b34b-4683-b35f-6cc65b047c0f 68428-500 HUMAN OTC DRUG Mentha viridis MENTHA SPICATA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MENTHA SPICATA 30 [hp_C]/1 N 20181231 68428-501_528eda4f-f1a8-4ddd-86d1-e3753484a251 68428-501 HUMAN OTC DRUG Mentholum MENTHOL, UNSPECIFIED FORM PELLET ORAL 20110802 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MENTHOL, UNSPECIFIED FORM 30 [hp_C]/1 N 20181231 68428-502_6266aa0f-5246-4713-beed-348a85242e78 68428-502 HUMAN OTC DRUG Mercurialis perennis MERCURIALIS PERENNIS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURIALIS PERENNIS 30 [hp_C]/1 N 20181231 68428-503_214f8ff2-ad87-484a-aa06-61a1f3fcaaab 68428-503 HUMAN OTC DRUG Mercurius corrosivus MERCURIC CHLORIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURIC CHLORIDE 30 [hp_C]/1 N 20181231 68428-504_5c1ccd71-9b5c-4f2a-8a80-f64b11fcc454 68428-504 HUMAN OTC DRUG Mercurius dulcis CALOMEL PELLET ORAL 20100423 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALOMEL 30 [hp_C]/1 N 20181231 68428-505_051ff977-10d2-4b0e-afdc-eb2f50b9efc6 68428-505 HUMAN OTC DRUG Mercurius iodatus flavus MERCUROUS IODIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCUROUS IODIDE 30 [hp_C]/1 N 20181231 68428-506_65e044f9-1f55-4904-9dbd-647fd57e6888 68428-506 HUMAN OTC DRUG Mercurius iodatus ruber MERCURIC IODIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURIC IODIDE 30 [hp_C]/1 N 20181231 68428-507_306b4b3a-3346-4222-b41e-ad4902c2f8a2 68428-507 HUMAN OTC DRUG Mercurius solubilius MERCURIUS SOLUBILIS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURIUS SOLUBILIS 30 [hp_C]/1 N 20181231 68428-508_a6983f91-2d67-40eb-83a2-1fbfb84e7311 68428-508 HUMAN OTC DRUG Mercurius sulphuratus ruber MERCURIC SULFIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURIC SULFIDE 30 [hp_C]/1 N 20181231 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FRUIT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MOMORDICA BALSAMINA IMMATURE FRUIT 300 [hp_C]/1 N 20181231 68428-514_764c5d6f-b873-4968-934a-4cf993149077 68428-514 HUMAN OTC DRUG Moschus MOSCHUS MOSCHIFERUS MUSK SAC RESIN PELLET ORAL 20110311 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MOSCHUS MOSCHIFERUS MUSK SAC RESIN 300 [hp_C]/1 N 20181231 68428-515_ec58df5a-9763-4496-af83-29d07430551b 68428-515 HUMAN OTC DRUG Murex purpurea HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE PELLET ORAL 20110131 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE 300 [hp_C]/1 N 20181231 68428-516_528118db-8e65-41ad-a8b8-6e1db095ab32 68428-516 HUMAN OTC DRUG Muriaticum acidum HYDROCHLORIC ACID PELLET ORAL 20100901 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HYDROCHLORIC ACID 300 [hp_C]/1 N 20181231 68428-517_5a377294-6736-4e95-8a5e-a563977c7e0c 68428-517 HUMAN OTC DRUG Mygale AVICULARIA AVICULARIA PELLET ORAL 20110315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AVICULARIA AVICULARIA 300 [hp_C]/1 N 20181231 68428-518_5b4a1238-cd52-4110-a0ae-b7a3fab2ff89 68428-518 HUMAN OTC DRUG Myrica cerifera MORELLA CERIFERA ROOT BARK PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MORELLA CERIFERA ROOT BARK 300 [hp_C]/1 N 20181231 68428-519_06af32a5-3a1c-4d78-9547-d5bdba3ed438 68428-519 HUMAN OTC DRUG Myristica sebifera VIROLA SEBIFERA RESIN PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VIROLA SEBIFERA RESIN 300 [hp_C]/1 N 20181231 68428-520_f8e9369e-b2bb-4b19-b81b-102f14037642 68428-520 HUMAN OTC DRUG Naja tripudians NAJA NAJA VENOM PELLET ORAL 20100629 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NAJA NAJA VENOM 30 [hp_C]/1 N 20181231 68428-521_8d7beaf5-803c-4a30-9dad-f01f4bfc7623 68428-521 HUMAN OTC DRUG Naphthalinum NAPHTHALENE PELLET ORAL 20100708 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NAPHTHALENE 30 [hp_C]/1 N 20181231 68428-522_a15a51ff-13a2-443b-8c21-7149fdc671e3 68428-522 HUMAN OTC DRUG Natrum arsenicicum SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE 30 [hp_C]/1 N 20181231 68428-523_9445d13f-d9ea-438c-8cef-4497fa6e0e4c 68428-523 HUMAN OTC DRUG Natrum bromatum SODIUM BROMIDE PELLET ORAL 20100519 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM BROMIDE 30 [hp_C]/1 N 20181231 68428-524_5e85872e-0ffa-4ae7-9f15-650ddc7583c2 68428-524 HUMAN OTC DRUG Natrum carbonicum SODIUM CARBONATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM CARBONATE 30 [hp_C]/1 N 20181231 68428-525_3a9a6aea-569d-4d19-9973-236dba3f5f3a 68428-525 HUMAN OTC DRUG Natrum fluoratum SODIUM FLUORIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM FLUORIDE 30 [hp_C]/1 N 20181231 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Homeopathic Products AQUA REGIA 300 [hp_C]/1 N 20181231 68428-535_2edb69db-be22-4937-aaa7-39606467f00d 68428-535 HUMAN OTC DRUG Nuphar luteum NUPHAR LUTEA ROOT PELLET ORAL 20100514 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NUPHAR LUTEA ROOT 300 [hp_C]/1 N 20181231 68428-536_562b4008-c604-4849-b7b3-e9aa8cceab28 68428-536 HUMAN OTC DRUG Nux moschata NUTMEG PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NUTMEG 30 [hp_C]/1 N 20181231 68428-537_95188f29-fad6-43ce-9cea-6aff9ee151f7 68428-537 HUMAN OTC DRUG Nux vomica STRYCHNOS NUX-VOMICA SEED PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/1 N 20181231 68428-538_075ec90d-42d6-46f9-95b7-1ced50631a69 68428-538 HUMAN OTC DRUG Ocimum basilicum BASIL PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BASIL 30 [hp_C]/1 N 20181231 68428-539_435d3047-4186-431d-b5ca-ca947da44a1e 68428-539 HUMAN OTC DRUG Oleander NERIUM OLEANDER LEAF PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NERIUM OLEANDER LEAF 30 [hp_C]/1 N 20181231 68428-540_973f4116-98fe-4a9f-8a5c-b928f14209c7 68428-540 HUMAN OTC DRUG Oleum morrhuae COD LIVER OIL PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COD LIVER OIL 30 [hp_C]/1 N 20181231 68428-541_ee464f1b-dc08-4c16-bdb1-ee988b7eb9a5 68428-541 HUMAN OTC DRUG Olibanum FRANKINCENSE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FRANKINCENSE 30 [hp_C]/1 N 20181231 68428-542_f8ef37ba-8252-4e05-bfc8-a31734400f9a 68428-542 HUMAN OTC DRUG Onosmodium virginianum ONOSMODIUM VIRGINIANUM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ONOSMODIUM VIRGINIANUM 30 [hp_C]/1 N 20181231 68428-543_811ebf7c-e750-4169-a371-81e6163c2026 68428-543 HUMAN OTC DRUG Oophorinum SUS SCROFA OVARY PELLET ORAL 20100810 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SUS SCROFA OVARY 30 [hp_C]/1 N 20181231 68428-544_8fa9d1a9-5b21-4b44-96ca-df2cc0d42bac 68428-544 HUMAN OTC DRUG Opuntia vulgaris OPUNTIA FICUS-INDICA PELLET ORAL 20100803 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products OPUNTIA FICUS-INDICA 30 [hp_C]/1 N 20181231 68428-545_339447ed-5d6a-43ef-8961-29c7b8706bf6 68428-545 HUMAN OTC DRUG Oreodaphne californica UMBELLULARIA CALIFORNICA LEAF PELLET ORAL 20100527 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products UMBELLULARIA CALIFORNICA LEAF 30 [hp_C]/1 N 20181231 68428-546_1a5c03a7-6931-47e9-85db-6511227a750f 68428-546 HUMAN OTC DRUG Origanum majorana ORIGANUM MAJORANA PELLET ORAL 20110214 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ORIGANUM MAJORANA 30 [hp_C]/1 N 20181231 68428-547_443fd9f1-bb49-40fa-b5da-e59dbc20ec6b 68428-547 HUMAN OTC DRUG Ornithogalum umbellatum ORNITHOGALUM UMBELLATUM PELLET ORAL 20100415 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ORNITHOGALUM UMBELLATUM 30 [hp_C]/1 N 20181231 68428-548_e8b21330-36e7-49e3-b680-08ed1409b981 68428-548 HUMAN OTC DRUG Osmium metallicum OSMIUM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products OSMIUM 30 [hp_C]/1 N 20181231 68428-549_3c87fd63-c457-4f6c-85b9-3e809923b9ae 68428-549 HUMAN OTC DRUG Oxalicum acidum OXALIC ACID DIHYDRATE PELLET ORAL 20100311 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products OXALIC ACID DIHYDRATE 30 [hp_C]/1 N 20181231 68428-550_a0f9e50d-8adc-4250-a328-698a93f48cde 68428-550 HUMAN OTC DRUG Paeonia officinalis PAEONIA OFFICINALIS ROOT PELLET ORAL 20110121 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PAEONIA OFFICINALIS ROOT 30 [hp_C]/1 N 20181231 68428-551_800092c9-2b27-4d1c-9026-f0a082d2bc58 68428-551 HUMAN OTC DRUG Palladium metallicum PALLADIUM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PALLADIUM 30 [hp_C]/1 N 20181231 68428-552_d453f90e-2b1a-4119-b8c2-e58ca5b81cbb 68428-552 HUMAN OTC DRUG Pancreatinum PANCRELIPASE PELLET ORAL 20100816 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PANCRELIPASE 30 [hp_C]/1 N 20181231 68428-553_6048ec30-b05c-4f7b-aa88-163730fe3ef2 68428-553 HUMAN OTC DRUG Pareira brava CHONDRODENDRON TOMENTOSUM ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHONDRODENDRON TOMENTOSUM ROOT 30 [hp_C]/1 N 20181231 68428-554_4d181652-aa85-45ab-82af-d1eafb647ce6 68428-554 HUMAN OTC DRUG Paris quadrifolia PARIS QUADRIFOLIA PELLET ORAL 20100316 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PARIS QUADRIFOLIA 30 [hp_C]/1 N 20181231 68428-555_03a32c05-e04e-44b0-9a27-db5a52f1d076 68428-555 HUMAN OTC DRUG Passiflora incarnata PASSIFLORA INCARNATA FLOWERING TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PASSIFLORA INCARNATA FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-556_afa2a61e-42c1-4855-966c-ade1453c8c5d 68428-556 HUMAN OTC DRUG Pecten GIANT SCALLOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GIANT SCALLOP 300 [hp_C]/1 N 20181231 68428-557_1babf3b0-2d16-4235-9dd2-63c3ccd7d12b 68428-557 HUMAN OTC DRUG Penthorum sedoides PENTHORUM SEDOIDES PELLET ORAL 20110401 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PENTHORUM SEDOIDES 30 [hp_C]/1 N 20181231 68428-558_5e32be9d-736f-4b33-b5c1-ec6a7547f5ca 68428-558 HUMAN OTC DRUG Pepsinum PEPSIN PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PEPSIN 300 [hp_C]/1 N 20181231 68428-559_914b65da-15fb-4c98-8132-79d301f80110 68428-559 HUMAN OTC DRUG Petroleum KEROSENE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products KEROSENE 30 [hp_C]/1 N 20181231 68428-560_331bda43-fafd-4c35-8e4d-1b12df74911a 68428-560 HUMAN OTC DRUG Phosphoricum acidum PHOSPHORIC ACID PELLET ORAL 20100112 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHOSPHORIC ACID 30 [hp_C]/1 N 20181231 68428-561_788d8ea5-fb87-487e-a287-c6309e9b86df 68428-561 HUMAN OTC DRUG Phosphorus PHOSPHORUS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHOSPHORUS 30 [hp_C]/1 N 20181231 68428-562_c03fb5ca-67a3-44c5-9894-1c652f117d26 68428-562 HUMAN OTC DRUG Physostigma venenosum PHYSOSTIGMA VENENOSUM SEED PELLET ORAL 20100316 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHYSOSTIGMA VENENOSUM SEED 30 [hp_C]/1 N 20181231 68428-563_a22a7347-a11b-4849-83c3-ea9c0db1bbef 68428-563 HUMAN OTC DRUG Phytolacca decandra PHYTOLACCA AMERICANA ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHYTOLACCA AMERICANA ROOT 30 [hp_C]/1 N 20181231 68428-564_53793ea9-2633-4393-a1cc-30457b312739 68428-564 HUMAN OTC DRUG Picricum acidum PICRIC ACID PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PICRIC ACID 30 [hp_C]/1 N 20181231 68428-565_38f85101-112b-4206-82f1-2289a273015c 68428-565 HUMAN OTC DRUG Pilocarpinum muriaticum PILOCARPINE HYDROCHLORIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PILOCARPINE HYDROCHLORIDE 30 [hp_C]/1 N 20181231 68428-567_cc9d1c11-7aca-49fb-bb78-87baebf67431 68428-567 HUMAN OTC DRUG Pilocarpus PILOCARPUS JABORANDI LEAF PELLET ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PILOCARPUS JABORANDI LEAF 30 [hp_C]/1 N 20181231 68428-568_7b99d637-c272-4d4e-9725-42901238969e 68428-568 HUMAN OTC DRUG Pimpinella saxifraga PIMPINELLA SAXIFRAGA ROOT PELLET ORAL 20100825 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PIMPINELLA SAXIFRAGA ROOT 30 [hp_C]/1 N 20181231 68428-569_5f379bf2-5181-4f0c-be96-7803867fcc36 68428-569 HUMAN OTC DRUG Pinus sylvestris PINUS SYLVESTRIS LEAFY TWIG PELLET ORAL 20090929 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PINUS SYLVESTRIS LEAFY TWIG 30 [hp_C]/1 N 20181231 68428-570_1ff19533-47bb-492e-9fb4-e404d141f4d3 68428-570 HUMAN OTC DRUG Plantago major PLANTAGO MAJOR PELLET ORAL 20091210 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PLANTAGO MAJOR 30 [hp_C]/1 N 20181231 68428-571_7ea70572-2bcf-42c2-8328-b3383861797b 68428-571 HUMAN OTC DRUG Platanus PLATANUS X ACERIFOLIA WHOLE PELLET ORAL 20091110 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PLATANUS X ACERIFOLIA WHOLE 300 [hp_C]/1 N 20181231 68428-572_0bd0381c-d217-4f73-93f8-9803dc2575d2 68428-572 HUMAN OTC DRUG Platinum metallicum PLATINUM PELLET ORAL 20101007 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PLATINUM 30 [hp_C]/1 N 20181231 68428-573_9269fdff-434a-4cf5-9217-7a5ea9c56ab9 68428-573 HUMAN OTC DRUG Plumbum aceticum LEAD ACETATE ANHYDROUS PELLET ORAL 20100826 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEAD ACETATE ANHYDROUS 30 [hp_C]/1 N 20181231 68428-574_effd2bd0-7210-4b71-95e7-1c4927576b1f 68428-574 HUMAN OTC DRUG Plumbum iodatum LEAD IODIDE PELLET ORAL 20101011 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEAD IODIDE 30 [hp_C]/1 N 20181231 68428-575_63864684-b777-457b-a057-ce074d167f14 68428-575 HUMAN OTC DRUG Plumbum metallicum LEAD PELLET ORAL 20100226 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEAD 30 [hp_C]/1 N 20181231 68428-576_1c61b0ff-e2eb-438d-96ea-63119ab93987 68428-576 HUMAN OTC DRUG Podophyllinum PODOPHYLLUM RESIN PELLET ORAL 20100324 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PODOPHYLLUM RESIN 30 [hp_C]/1 N 20181231 68428-577_931d7c0f-0b87-4426-9ffc-ec88b4791d31 68428-577 HUMAN OTC DRUG Podophyllum peltatum PODOPHYLLUM PELLET ORAL 20100630 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PODOPHYLLUM 30 [hp_C]/1 N 20181231 68428-578_566d85af-5148-4534-b669-241fdb836be6 68428-578 HUMAN OTC DRUG Populus candicans POPULUS BALSAMIFERA LEAF BUD PELLET ORAL 20100317 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POPULUS BALSAMIFERA LEAF BUD 30 [hp_C]/1 N 20181231 68428-579_2c5edcaa-99e2-4590-8498-bef520f9f0b6 68428-579 HUMAN OTC DRUG Populus tremuloides POPULUS TREMULOIDES BARK - POPULUS TREMULOIDES LEAF PELLET ORAL 20100517 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POPULUS TREMULOIDES BARK; POPULUS TREMULOIDES LEAF 30; 30 [hp_C]/1; [hp_C]/1 N 20181231 68428-580_813c3dde-56ed-4689-a925-81e9019e50c7 68428-580 HUMAN OTC DRUG Primula veris PRIMULA VERIS PELLET ORAL 20091208 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PRIMULA VERIS 30 [hp_C]/1 N 20181231 68428-581_30f75b4f-94d3-4e6c-825a-b618a1c62827 68428-581 HUMAN OTC DRUG Prunus spinosa PRUNUS SPINOSA BUDDING TOP PELLET ORAL 20090928 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PRUNUS SPINOSA BUDDING TOP 30 [hp_C]/1 N 20181231 68428-582_07888943-ec9c-4b6c-b7cc-cef195b480a2 68428-582 HUMAN OTC DRUG Prunus virginiana PRUNUS SEROTINA BARK PELLET ORAL 20101019 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PRUNUS SEROTINA BARK 30 [hp_C]/1 N 20181231 68428-583_0e4475d4-72d9-4ca3-9570-7ccd14d5334e 68428-583 HUMAN OTC DRUG Ptelea trifoliata PTELEA TRIFOLIATA BARK PELLET ORAL 20090929 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PTELEA TRIFOLIATA BARK 30 [hp_C]/1 N 20181231 68428-584_f5b7a047-3211-43a2-9c90-04cf4e8cbe3c 68428-584 HUMAN OTC DRUG Pulex irritans PULEX IRRITANS PELLET ORAL 20100303 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PULEX IRRITANS 30 [hp_C]/1 N 20181231 68428-585_4d871271-ed14-45cc-81f0-45aad1eb54a4 68428-585 HUMAN OTC DRUG Pulsatilla PULSATILLA VULGARIS PELLET ORAL 20091110 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PULSATILLA VULGARIS 30 [hp_C]/1 N 20181231 68428-586_cc5da3ed-6684-4450-bc22-34bcab9607b4 68428-586 HUMAN OTC DRUG Pulsatilla nuttalliana ANEMONE PATENS PELLET ORAL 20101208 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANEMONE PATENS 30 [hp_C]/1 N 20181231 68428-587_dd102d2c-ef92-44bc-808e-b2bf8e0fd3fb 68428-587 HUMAN OTC DRUG Pyrethrum parthenium TANACETUM PARTHENIUM PELLET ORAL 20091106 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TANACETUM PARTHENIUM 30 [hp_C]/1 N 20181231 68428-588_280e452b-9cb9-4e8b-b873-809c1ff43f15 68428-588 HUMAN OTC DRUG Pyrogenium RANCID BEEF PELLET ORAL 20100504 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RANCID BEEF 30 [hp_C]/1 N 20181231 68428-589_7d7dc890-5227-40d3-a8c8-77378439c84a 68428-589 HUMAN OTC DRUG Quebracho ASPIDOSPERMA QUEBRACHO-BLANCO BARK PELLET ORAL 20091008 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASPIDOSPERMA QUEBRACHO-BLANCO BARK 30 [hp_C]/1 N 20181231 68428-590_03e3aabe-d162-4040-84d1-2c19f7d1c10d 68428-590 HUMAN OTC DRUG Quercus glandium spiritus QUERCUS ROBUR NUT PELLET ORAL 20091008 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUERCUS ROBUR NUT 30 [hp_C]/1 N 20181231 68428-591_fb1eb0bb-00d1-4e12-84bb-9c619fdc04df 68428-591 HUMAN OTC DRUG Quercus robur QUERCUS ROBUR TWIG BARK PELLET ORAL 20091106 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUERCUS ROBUR TWIG BARK 30 [hp_C]/1 N 20181231 68428-592_830bf007-c307-4f7c-95ee-a1482bffec9f 68428-592 HUMAN OTC DRUG Radium Bromatum RADIUM BROMIDE PELLET ORAL 20091117 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RADIUM BROMIDE 30 [hp_C]/1 N 20181231 68428-593_2a5c3625-74f6-426d-8a09-4dfaee2d3561 68428-593 HUMAN OTC DRUG Ranunculus Bulbosus RANUNCULUS BULBOSUS PELLET ORAL 20090929 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RANUNCULUS BULBOSUS 30 [hp_C]/1 N 20181231 68428-594_c95c8ac1-80c1-46e6-8c8b-c349d474ebb6 68428-594 HUMAN OTC DRUG Ranunc Scel RANUNCULUS SCELERATUS PELLET ORAL 20091208 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RANUNCULUS SCELERATUS 30 [hp_C]/1 N 20181231 68428-595_cafc9bbc-385c-44c1-9f19-1aaaab03f0f7 68428-595 HUMAN OTC DRUG Raphanus sativus RADISH PELLET ORAL 20091013 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RADISH 30 [hp_C]/1 N 20181231 68428-596_b45aadcd-ebf0-4a78-8abf-6281cd713fd5 68428-596 HUMAN OTC DRUG Ratanhia KRAMERIA LAPPACEA ROOT PELLET ORAL 20091028 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products KRAMERIA LAPPACEA ROOT 30 [hp_C]/1 N 20181231 68428-597_6b9e62bc-7fe0-4782-b1d4-bbe00954cc5d 68428-597 HUMAN OTC DRUG Rauwolfia serpentina RAUWOLFIA SERPENTINA PELLET ORAL 20100303 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RAUWOLFIA SERPENTINA 30 [hp_C]/1 N 20181231 68428-598_6482e327-e3b9-4472-9fd1-d2dc09a0ea90 68428-598 HUMAN OTC DRUG Rhamnus frangula FRANGULA ALNUS BARK PELLET ORAL 20091231 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FRANGULA ALNUS BARK 30 [hp_C]/1 N 20181231 68428-599_49232ca8-0558-4fab-91c7-2cbf043fdc42 68428-599 HUMAN OTC DRUG Rhododendron chrysanthum RHODODENDRON AUREUM LEAF PELLET ORAL 20100525 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RHODODENDRON AUREUM LEAF 30 [hp_C]/1 N 20181231 68428-600_607d2162-586a-4d2f-9038-fd087a756505 68428-600 HUMAN OTC DRUG Rhus aromatica RHUS AROMATICA ROOT BARK PELLET ORAL 20100315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RHUS AROMATICA ROOT BARK 30 [hp_C]/1 N 20181231 68428-601_2570f448-cf91-41e1-ab26-6754c847d9ae 68428-601 HUMAN OTC DRUG Rhus glabra RHUS GLABRA TOP PELLET ORAL 20100903 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RHUS GLABRA TOP 30 [hp_C]/1 N 20181231 68428-602_4095912f-52fd-454a-bf36-3125c7f1b695 68428-602 HUMAN OTC DRUG Rhus toxicodendron TOXICODENDRON PUBESCENS LEAF PELLET ORAL 20100514 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TOXICODENDRON PUBESCENS LEAF 30 [hp_C]/1 N 20181231 68428-603_60b990f0-467b-4027-a24f-73658bfe6c47 68428-603 HUMAN OTC DRUG Rhus venenata TOXICODENDRON VERNIX LEAFY TWIG PELLET ORAL 20100305 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TOXICODENDRON VERNIX LEAFY TWIG 30 [hp_C]/1 N 20181231 68428-604_b1f6a043-95af-4482-8df6-3e9cf491c95a 68428-604 HUMAN OTC DRUG Ricinus communis RICINUS COMMUNIS SEED PELLET ORAL 20110211 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RICINUS COMMUNIS SEED 30 [hp_C]/1 N 20181231 68428-605_6d3e694f-49be-4920-8ff0-3f6fbd8912f4 68428-605 HUMAN OTC DRUG Robinia pseudoacacia ROBINIA PSEUDOACACIA BARK PELLET ORAL 20100120 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ROBINIA PSEUDOACACIA BARK 30 [hp_C]/1 N 20181231 68428-606_1e74cd86-62d1-4615-a552-bb9911e60fb8 68428-606 HUMAN OTC DRUG Rosa damascena ROSA X DAMASCENA FLOWERING TOP PELLET ORAL 20110211 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ROSA X DAMASCENA FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-607_9b8bbd0c-8c01-4fe1-8390-ab5f69341b63 68428-607 HUMAN OTC DRUG Rumex acetosa RUMEX ACETOSA LEAF PELLET ORAL 20110218 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RUMEX ACETOSA LEAF 30 [hp_C]/1 N 20181231 68428-608_0c6dc79b-699b-484a-9cab-8348f818f05f 68428-608 HUMAN OTC DRUG Rumex Crispus RUMEX CRISPUS ROOT PELLET ORAL 20100514 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RUMEX CRISPUS ROOT 30 [hp_C]/1 N 20181231 68428-609_57187d4c-e521-4bbc-a048-931e15e5c84e 68428-609 HUMAN OTC DRUG Ruta graveolens RUTA GRAVEOLENS FLOWERING TOP PELLET ORAL 20091231 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RUTA GRAVEOLENS FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-610_f8378cdc-defc-4fe6-8bc0-42517ec2487a 68428-610 HUMAN OTC DRUG Sabadilla SCHOENOCAULON OFFICINALE SEED PELLET ORAL 20100112 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SCHOENOCAULON OFFICINALE SEED 30 [hp_C]/1 N 20181231 68428-611_83b09f6d-da49-43cf-9462-072075b6cfdc 68428-611 HUMAN OTC DRUG Sabal SAW PALMETTO PELLET ORAL 20100514 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SAW PALMETTO 30 [hp_C]/1 N 20181231 68428-612_865a11dc-8ec2-47e9-896f-21ee08de146b 68428-612 HUMAN OTC DRUG Sabina JUNIPERUS SABINA LEAF PELLET ORAL 20091008 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products JUNIPERUS SABINA LEAF 30 [hp_C]/1 N 20181231 68428-613_8a39d1c3-b666-49fc-b9ba-a20dc692cb5e 68428-613 HUMAN OTC DRUG Sac lac LACTOSE, UNSPECIFIED FORM PELLET ORAL 20100811 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACTOSE, UNSPECIFIED FORM 30 [hp_C]/1 N 20181231 68428-614_d1e52dbe-5988-4e75-a413-bf89afd0a13a 68428-614 HUMAN OTC DRUG Saccharum officinale SUCROSE PELLET ORAL 20101116 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SUCROSE 30 [hp_C]/1 N 20181231 68428-615_ff5c8408-35da-4f14-9621-a9ae7dfeb665 68428-615 HUMAN OTC DRUG Salicylicum acidum SALICYLIC ACID PELLET ORAL 20100120 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SALICYLIC ACID 30 [hp_C]/1 N 20181231 68428-616_8abe917c-3942-41d9-8023-089a2eb33afb 68428-616 HUMAN OTC DRUG Salix nigra SALIX NIGRA BARK PELLET ORAL 20101007 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SALIX NIGRA BARK 30 [hp_C]/1 N 20181231 68428-617_570090e4-f851-4191-9b52-dee1e37736f7 68428-617 HUMAN OTC DRUG Salvia officinalis SAGE PELLET ORAL 20091016 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SAGE 30 [hp_C]/1 N 20181231 68428-618_00ee30ab-2e8c-4e25-935b-0af843240a86 68428-618 HUMAN OTC DRUG Sambucus nigra SAMBUCUS NIGRA FLOWERING TOP PELLET ORAL 20100324 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SAMBUCUS NIGRA FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-619_5e8a789c-6f62-418a-8177-08b2ff507d46 68428-619 HUMAN OTC DRUG Sanguinaria canadensis SANGUINARIA CANADENSIS ROOT PELLET ORAL 20100223 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SANGUINARIA CANADENSIS ROOT 30 [hp_C]/1 N 20181231 68428-620_4a706010-ee2e-426b-ae52-032b50d3d21e 68428-620 HUMAN OTC DRUG Sanguinarinum nitricum SANGUINARINE NITRATE PELLET ORAL 20100504 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SANGUINARINE NITRATE 30 [hp_C]/1 N 20181231 68428-621_42e35f25-a94c-4ff1-9fe5-2e4698de26e5 68428-621 HUMAN OTC DRUG Sanicula WATER PELLET ORAL 20091029 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products WATER 30 [hp_C]/1 N 20181231 68428-622_9aae7394-a9a4-4c99-9654-76016fd65d4e 68428-622 HUMAN OTC DRUG Santoninum SANTONIN PELLET ORAL 20100316 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SANTONIN 30 [hp_C]/1 N 20181231 68428-623_72d16a02-58ce-4a23-9a21-72be94941998 68428-623 HUMAN OTC DRUG Sarcolacticum acidum LACTIC ACID, L- PELLET ORAL 20101007 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACTIC ACID, L- 30 [hp_C]/1 N 20181231 68428-624_b1e26e28-3d29-4095-af13-9af192adb32d 68428-624 HUMAN OTC DRUG Sarracenia purpurea SARRACENIA PURPUREA PELLET ORAL 20091106 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SARRACENIA PURPUREA 30 [hp_C]/1 N 20181231 68428-625_64bc4a33-9b4b-4762-9b75-dd87b5660112 68428-625 HUMAN OTC DRUG Sarsaparilla SARSAPARILLA ROOT PELLET ORAL 20100504 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SARSAPARILLA ROOT 30 [hp_C]/1 N 20181231 68428-626_0459190d-1b32-42c0-8207-5f49c502a2f5 68428-626 HUMAN OTC DRUG Scolopendra SCOLOPENDRA SUBSPINIPES PELLET ORAL 20101019 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SCOLOPENDRA SUBSPINIPES 30 [hp_C]/1 N 20181231 68428-627_7496ad10-7ff7-4f5a-9dff-97181bc3107a 68428-627 HUMAN OTC DRUG Scrophularia nodosa SCROPHULARIA NODOSA PELLET ORAL 20091231 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SCROPHULARIA NODOSA 30 [hp_C]/1 N 20181231 68428-628_462bac01-e331-4d69-b3b0-8f779673292e 68428-628 HUMAN OTC DRUG Scutellaria lateriflora SCUTELLARIA LATERIFLORA PELLET ORAL 20100401 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SCUTELLARIA LATERIFLORA 30 [hp_C]/1 N 20181231 68428-629_be7c4eff-2fcd-4d10-8919-1cac7c6713d9 68428-629 HUMAN OTC DRUG Secale Cornutum CLAVICEPS PURPUREA SCLEROTIUM PELLET ORAL 20091210 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CLAVICEPS PURPUREA SCLEROTIUM 30 [hp_C]/1 N 20181231 68428-630_83f5d081-11cd-4e6b-ac21-2c4f98d12325 68428-630 HUMAN OTC DRUG Sedum acre SEDUM ACRE PELLET ORAL 20091029 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SEDUM ACRE 30 [hp_C]/1 N 20181231 68428-631_26f794f5-a9fe-4f70-91a9-1c2b7f3bdf63 68428-631 HUMAN OTC DRUG Selenium metallicum SELENIUM PELLET ORAL 20100409 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SELENIUM 30 [hp_C]/1 N 20181231 68428-632_89427763-3492-4397-863e-5052d3f23a9c 68428-632 HUMAN OTC DRUG Senecio aureus PACKERA AUREA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PACKERA AUREA 30 [hp_C]/1 N 20181231 68428-633_d091af12-25c7-45eb-a2a1-f48b1a93413d 68428-633 HUMAN OTC DRUG Senega officinalis POLYGALA SENEGA ROOT PELLET ORAL 20100312 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POLYGALA SENEGA ROOT 30 [hp_C]/1 N 20181231 68428-634_aef3fdf0-ca32-4b49-a1ef-c80a3a001db6 68428-634 HUMAN OTC DRUG Senna SENNA LEAF PELLET ORAL 20091008 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SENNA LEAF 30 [hp_C]/1 N 20181231 68428-635_80817b90-85de-4e49-b953-4066e4b52b19 68428-635 HUMAN OTC DRUG Sepia SEPIA OFFICINALIS JUICE PELLET ORAL 20091112 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SEPIA OFFICINALIS JUICE 30 [hp_C]/1 N 20181231 68428-636_b979162c-480f-4498-b130-8ab8a67013c4 68428-636 HUMAN OTC DRUG Serum anguillae ANGUILLA ROSTRATA BLOOD SERUM PELLET ORAL 20091021 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANGUILLA ROSTRATA BLOOD SERUM 30 [hp_C]/1 N 20181231 68428-638_2b75f2d3-6265-4490-98d7-5cc949b5af9c 68428-638 HUMAN OTC DRUG Silicea SILICON DIOXIDE PELLET ORAL 20100114 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SILICON DIOXIDE 30 [hp_C]/1 N 20181231 68428-639_58c43bdf-4b82-48f9-8a8e-f34b687c4efe 68428-639 HUMAN OTC DRUG Sinapis nigra BLACK MUSTARD SEED PELLET ORAL 20091028 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLACK MUSTARD SEED 30 [hp_C]/1 N 20181231 68428-641_3f79da97-e2e8-45fa-8ee2-602b1ce414b8 68428-641 HUMAN OTC DRUG Solidago virgaurea SOLIDAGO VIRGAUREA FLOWERING TOP PELLET ORAL 20091028 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SOLIDAGO VIRGAUREA FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-642_ea684b2d-f6dd-4424-bacd-ad328d773f25 68428-642 HUMAN OTC DRUG Spigelia Anthelmia SPIGELIA ANTHELMIA PELLET ORAL 20091231 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SPIGELIA ANTHELMIA 30 [hp_C]/1 N 20181231 68428-643_74c605ed-7dd7-40e9-81bb-5d93d9e146d4 68428-643 HUMAN OTC DRUG Spiraea ulmaria FILIPENDULA ULMARIA ROOT PELLET ORAL 20100621 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FILIPENDULA ULMARIA ROOT 30 [hp_C]/1 N 20181231 68428-644_eead868a-fe84-4f79-990e-a4fa855dcd55 68428-644 HUMAN OTC DRUG Spongia Tosta SILICON DIOXIDE PELLET ORAL 20091120 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_C]/1 N 20181231 68428-645_54c8cd5d-03c3-4cc3-b990-645e7162daf8 68428-645 HUMAN OTC DRUG Stannum iodatum STANNOUS IODIDE PELLET ORAL 20100212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STANNOUS IODIDE 30 [hp_C]/1 N 20181231 68428-646_0483d882-909f-489f-990e-5673e8184581 68428-646 HUMAN OTC DRUG Stannum metallicum TIN PELLET ORAL 20100615 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TIN 30 [hp_C]/1 N 20181231 68428-647_3d151ca8-44e7-456c-957f-1537ad463247 68428-647 HUMAN OTC DRUG Staphysagria DELPHINIUM 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[hp_C]/1 N 20181231 68428-652_3bb13ff7-f2f0-449f-9208-af31c8b9430b 68428-652 HUMAN OTC DRUG Strontium carbonicum STRONTIUM CARBONATE PELLET ORAL 20101011 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STRONTIUM CARBONATE 30 [hp_C]/1 N 20181231 68428-653_54780147-f0ed-476e-b39f-afe6a568dd98 68428-653 HUMAN OTC DRUG Strophanthus hispidus STROPHANTHUS HISPIDUS SEED PELLET ORAL 20100826 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STROPHANTHUS HISPIDUS SEED 30 [hp_C]/1 N 20181231 68428-654_c5ce141e-9a7f-44a4-8599-74f5474c9099 68428-654 HUMAN OTC DRUG Strychninum STRYCHNINE PELLET ORAL 20091102 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STRYCHNINE 30 [hp_C]/1 N 20181231 68428-655_7a3282f7-05f2-4b71-a30d-49606f6ae749 68428-655 HUMAN OTC DRUG Sulphur SULFUR PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SULFUR 30 [hp_C]/1 N 20181231 68428-656_84955e9d-f9f9-4459-8f01-e3380644cb90 68428-656 HUMAN OTC DRUG Sulphur iodatum SULFUR IODIDE PELLET ORAL 20091008 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SULFUR IODIDE 30 [hp_C]/1 N 20181231 68428-657_471b9f45-9743-4c01-a8fe-e5afc620e5fd 68428-657 HUMAN OTC DRUG Sulphuricum acidum SULFURIC ACID PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SULFURIC ACID 30 [hp_C]/1 N 20181231 68428-658_95607310-8c4a-45df-ae0c-98dfac9d9347 68428-658 HUMAN OTC DRUG Sumbul FERULA SUMBUL ROOT PELLET ORAL 20100317 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERULA SUMBUL ROOT 30 [hp_C]/1 N 20181231 68428-659_a96d2a49-27c1-4913-8723-1a882ab09383 68428-659 HUMAN OTC DRUG Symphytum Off COMFREY ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COMFREY ROOT 30 [hp_C]/1 N 20181231 68428-660_7718a336-173a-4f2d-9b95-2ba9bd558a45 68428-660 HUMAN OTC DRUG Syzygium jambolanum SYZYGIUM CUMINI SEED PELLET ORAL 20100408 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SYZYGIUM CUMINI SEED 30 [hp_C]/1 N 20181231 68428-661_b4395e91-8534-4eca-9b18-700b13d5da72 68428-661 HUMAN OTC DRUG Tabacum TOBACCO LEAF PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TOBACCO LEAF 30 [hp_C]/1 N 20181231 68428-662_1dc29c4c-8bd6-4e6e-86c9-cd65c564dba5 68428-662 HUMAN OTC DRUG Tanacetum vulgare TANACETUM VULGARE TOP PELLET ORAL 20101214 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TANACETUM VULGARE TOP 30 [hp_C]/1 N 20181231 68428-663_61559578-3662-41d9-9695-4488fdd1a2f1 68428-663 HUMAN OTC DRUG Taraxacum officinale TARAXACUM OFFICINALE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TARAXACUM OFFICINALE 30 [hp_C]/1 N 20181231 68428-664_232a9647-9f53-4168-afef-9f537d8fed0e 68428-664 HUMAN OTC DRUG Tarentula cubensis CITHARACANTHUS SPINICRUS PELLET ORAL 20100517 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CITHARACANTHUS SPINICRUS 30 [hp_C]/1 N 20181231 68428-665_1d6c008b-49a0-431e-afa1-e2ae413e7a4a 68428-665 HUMAN OTC DRUG Tarentula hispana LYCOSA TARANTULA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYCOSA TARANTULA 30 [hp_C]/1 N 20181231 68428-666_00daf578-6643-46a6-8e9d-8c884ea2abe8 68428-666 HUMAN OTC DRUG Tartaricum acidum TARTARIC ACID PELLET ORAL 20100901 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TARTARIC ACID 30 [hp_C]/1 N 20181231 68428-667_fe1671be-2954-4962-88a0-dec721ebcf3b 68428-667 HUMAN OTC DRUG Tellurium metallicum TELLURIUM PELLET ORAL 20100826 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TELLURIUM 30 [hp_C]/1 N 20181231 68428-668_5d155e86-a1ad-4e3a-bc2c-344e60fe609c 68428-668 HUMAN OTC DRUG Terebinthina TURPENTINE OIL PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TURPENTINE OIL 30 [hp_C]/1 N 20181231 68428-669_afe21306-778e-4897-8027-03b752e5242d 68428-669 HUMAN OTC DRUG Teucrium marum TEUCRIUM MARUM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TEUCRIUM MARUM 30 [hp_C]/1 N 20181231 68428-670_e089e4e8-d7c9-43fb-9d16-e6e438630d94 68428-670 HUMAN OTC DRUG Thallium metallicum THALLIUM PELLET ORAL 20100401 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THALLIUM 30 [hp_C]/1 N 20181231 68428-671_b27cb753-a790-4cce-95c0-3a45a68f855a 68428-671 HUMAN OTC DRUG Thea sinensis GREEN TEA LEAF PELLET ORAL 20101208 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GREEN TEA LEAF 30 [hp_C]/1 N 20181231 68428-672_ae38ec70-661f-48c7-a8fe-a583aaaefee3 68428-672 HUMAN OTC DRUG Theobrominum THEOBROMINE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THEOBROMINE 30 [hp_C]/1 N 20181231 68428-673_5bfbd43d-14dd-4703-b935-682b8ee15be8 68428-673 HUMAN OTC DRUG Theridion THERIDION CURASSAVICUM PELLET ORAL 20100922 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THERIDION CURASSAVICUM 30 [hp_C]/1 N 20181231 68428-674_f1e3ec67-2153-48a2-9f97-598bffebb13d 68428-674 HUMAN OTC DRUG Thiosinaminum ALLYLTHIOUREA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALLYLTHIOUREA 30 [hp_C]/1 N 20181231 68428-675_2bb7f1de-9bac-42e8-ab08-d3ee8f4eca97 68428-675 HUMAN OTC DRUG Thlaspi bursa-pastoris CAPSELLA BURSA-PASTORIS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAPSELLA BURSA-PASTORIS 30 [hp_C]/1 N 20181231 68428-676_4300f97c-8a15-4275-a880-00998240ad11 68428-676 HUMAN OTC DRUG Thuja lobbi THUJA PLICATA LEAF PELLET ORAL 20100519 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THUJA PLICATA LEAF 30 [hp_C]/1 N 20181231 68428-677_1243fa64-65a5-43ca-a8eb-873a46d2979c 68428-677 HUMAN OTC DRUG Thuja Occidentalis THUJA OCCIDENTALIS LEAFY TWIG PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_C]/1 N 20181231 68428-678_1985f58e-096c-4615-9140-0d442869a845 68428-678 HUMAN OTC DRUG Thymolum THYMOL PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THYMOL 30 [hp_C]/1 N 20181231 68428-679_aa527500-c1fe-4b60-ac00-eef40769ff15 68428-679 HUMAN OTC DRUG Thyroidinum THYROID, UNSPECIFIED PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THYROID, UNSPECIFIED 30 [hp_C]/1 N 20181231 68428-680_dc67cb88-b7a8-427d-8613-838aac1c4cc8 68428-680 HUMAN OTC DRUG Tilia europaea TILIA X EUROPAEA FLOWER PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TILIA X EUROPAEA FLOWER 30 [hp_C]/1 N 20181231 68428-681_863ec489-d9ec-48b4-9f55-09eaea87f8ec 68428-681 HUMAN OTC DRUG Titanium metallicum TITANIUM PELLET ORAL 20110121 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TITANIUM 30 [hp_C]/1 N 20181231 68428-682_0c345e46-50a1-4441-904a-4d92c96edbe9 68428-682 HUMAN OTC DRUG Torula cerevisiae SACCHAROMYCES CEREVISIAE PELLET ORAL 20101119 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SACCHAROMYCES CEREVISIAE 30 [hp_C]/1 N 20181231 68428-683_750f5b3c-d31b-4660-8200-b3907b9a3ddc 68428-683 HUMAN OTC DRUG Trifolium pratense TRIFOLIUM PRATENSE FLOWER PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TRIFOLIUM PRATENSE FLOWER 30 [hp_C]/1 N 20181231 68428-684_db45426c-9def-449f-93d9-fc24972c4da1 68428-684 HUMAN OTC DRUG Trillium pendulum TRILLIUM ERECTUM ROOT PELLET ORAL 20101215 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TRILLIUM ERECTUM ROOT 30 [hp_C]/1 N 20181231 68428-685_d0c5ab03-74f0-4093-a9e7-53ccc462ab7a 68428-685 HUMAN OTC DRUG Triticum repens ELYMUS REPENS ROOT PELLET ORAL 20100325 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ELYMUS REPENS ROOT 30 [hp_C]/1 N 20181231 68428-686_e6291113-0f50-4135-828d-9667a6d9247d 68428-686 HUMAN OTC DRUG Ulmus fulva ULMUS RUBRA BARK PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ULMUS RUBRA BARK 30 [hp_C]/1 N 20181231 68428-687_1c46fdf3-9ec4-4314-824c-51815124974a 68428-687 HUMAN OTC DRUG Uranium nitricum URANYL NITRATE HEXAHYDRATE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products URANYL NITRATE HEXAHYDRATE 30 [hp_C]/1 N 20181231 68428-688_f1c86c54-b72f-4466-9825-f2c6e2820211 68428-688 HUMAN OTC DRUG Urea UREA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products UREA 30 [hp_C]/1 N 20181231 68428-689_1ae60f74-fd37-47d9-b196-d1723c1c779c 68428-689 HUMAN OTC DRUG Urtica Urens URTICA URENS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products URTICA URENS 30 [hp_C]/1 N 20181231 68428-690_fd2b9f2a-b211-4e41-a3d9-7c378c9a27fb 68428-690 HUMAN OTC DRUG Ustilago maidis USTILAGO MAYDIS PELLET ORAL 20100701 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products USTILAGO MAYDIS 30 [hp_C]/1 N 20181231 68428-691_19a09644-8731-4035-aedc-8faa2b57baab 68428-691 HUMAN OTC DRUG Uva-ursi ARCTOSTAPHYLOS UVA-URSI LEAF PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARCTOSTAPHYLOS UVA-URSI LEAF 30 [hp_C]/1 N 20181231 68428-692_fcddf9da-589c-4d17-8ad7-2625d1b54bae 68428-692 HUMAN OTC DRUG Vaccinium myrtillus BILBERRY PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BILBERRY 30 [hp_C]/1 N 20181231 68428-693_570414a9-5f74-4cf5-aea7-a8fc716df99a 68428-693 HUMAN OTC DRUG Valeriana Officinalis VALERIAN PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VALERIAN 30 [hp_C]/1 N 20181231 68428-694_3d6510d4-8ff8-42bf-8fbc-c3865d0339e7 68428-694 HUMAN OTC DRUG Vanadium metallicum VANADIUM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VANADIUM 30 [hp_C]/1 N 20181231 68428-695_3b1b36a1-47d8-4ba6-9e04-1acbb1982981 68428-695 HUMAN OTC DRUG Venus mercenaria NORTHERN QUAHOG PELLET ORAL 20110315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NORTHERN QUAHOG 30 [hp_C]/1 N 20181231 68428-696_55166c40-8f8d-4aea-9a35-8bd5f48e772e 68428-696 HUMAN OTC DRUG Veratrum album VERATRUM ALBUM ROOT PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VERATRUM ALBUM ROOT 30 [hp_C]/1 N 20181231 68428-697_04535dd9-43a5-46e8-99b9-9b110e9f766f 68428-697 HUMAN OTC DRUG Veratrum viride NORTHERN QUAHOG PELLET ORAL 20091231 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NORTHERN QUAHOG 30 [hp_C]/1 N 20181231 68428-698_eacc96c9-ecf6-4e23-8d14-638444e5b6e6 68428-698 HUMAN OTC DRUG Verbascum thapsus VERBASCUM THAPSUS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VERBASCUM THAPSUS 30 [hp_C]/1 N 20181231 68428-699_202e19d8-064e-4bff-916a-a2b05dda1e57 68428-699 HUMAN OTC DRUG Verbena officinalis VERBENA OFFICINALIS PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VERBENA OFFICINALIS 30 [hp_C]/1 N 20181231 68428-700_9c247a48-37f4-4d15-9cb5-d8e2e39f8885 68428-700 HUMAN OTC DRUG Vesicaria ALYSSOIDES UTRICULATA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALYSSOIDES UTRICULATA 30 [hp_C]/1 N 20181231 68428-701_e40c804c-6f35-46d2-806b-39bb9fbcd2f9 68428-701 HUMAN OTC DRUG Vespa crabro VESPA CRABRO PELLET ORAL 20100714 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VESPA CRABRO 30 [hp_C]/1 N 20181231 68428-702_cacc0092-df44-4ba8-8669-bcfc9364b279 68428-702 HUMAN OTC DRUG Viburnum opulus VIBURNUM OPULUS BARK PELLET ORAL 20110202 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VIBURNUM OPULUS BARK 30 [hp_C]/1 N 20181231 68428-703_b6547486-665a-4a02-b525-72ed87e87163 68428-703 HUMAN OTC DRUG Vinca minor VINCA MINOR PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VINCA MINOR 30 [hp_C]/1 N 20181231 68428-704_f392510e-ffb8-494b-8dfd-b40f4f7c5daa 68428-704 HUMAN OTC DRUG Violo odorata VIOLA ODORATA PELLET ORAL 20100401 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VIOLA ODORATA 30 [hp_C]/1 N 20181231 68428-705_cac6676f-2246-4474-8d34-9dd82b2d4cd6 68428-705 HUMAN OTC DRUG Vipera berus VIPERA BERUS VENOM PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VIPERA BERUS VENOM 30 [hp_C]/1 N 20181231 68428-706_23b77573-cf4d-44a2-a300-a4614a3be101 68428-706 HUMAN OTC DRUG Viscum album VISCUM ALBUM FRUITING TOP PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VISCUM ALBUM FRUITING TOP 30 [hp_C]/1 N 20181231 68428-707_5f4128bb-3596-40b2-be8b-096bec67328e 68428-707 HUMAN OTC DRUG Wiesbaden WATER PELLET ORAL 20101129 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products WATER 30 [hp_C]/1 N 20181231 68428-708_7b05af8e-cc04-41d5-9605-37478b402072 68428-708 HUMAN OTC DRUG Wyethia helenioides WYETHIA HELENIOIDES ROOT PELLET ORAL 20100311 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products WYETHIA HELENIOIDES ROOT 30 [hp_C]/1 N 20181231 68428-709_10a494d2-e5a1-4fc7-96ea-cef91bfd50b6 68428-709 HUMAN OTC DRUG Xanthoxylum fraxineum ZANTHOXYLUM AMERICANUM BARK PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ZANTHOXYLUM AMERICANUM BARK 30 [hp_C]/1 N 20181231 68428-710_c7e577ac-3277-4f3b-a6a9-5772bba4a03b 68428-710 HUMAN OTC DRUG Yucca filamentosa YUCCA FILAMENTOSA PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products YUCCA FILAMENTOSA 30 [hp_C]/1 N 20181231 68428-711_fe8ab3ad-ce77-414e-9054-7d069daf1ff6 68428-711 HUMAN OTC DRUG Zincum iodatum ZINC IODIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ZINC IODIDE 30 [hp_C]/1 N 20181231 68428-712_91868b55-da32-4216-9ca3-24db1ba7d7ad 68428-712 HUMAN OTC DRUG Zincum metallicum ZINC PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ZINC 30 [hp_C]/1 N 20181231 68428-713_b4abfaf9-ab8a-47c5-90ed-c2eb7e874726 68428-713 HUMAN OTC DRUG Zincum phosphoratum ZINC PHOSPHIDE PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ZINC PHOSPHIDE 30 [hp_C]/1 N 20181231 68428-714_d0244c4e-338c-4803-8550-46f8715b944e 68428-714 HUMAN OTC DRUG Zincum picricum ZINC PICRATE NONAHYDRATE PELLET ORAL 20101014 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ZINC PICRATE NONAHYDRATE 30 [hp_C]/1 N 20181231 68428-715_d031c5c3-3855-4b10-873b-75728e5dbdfa 68428-715 HUMAN OTC DRUG Zincum sulphuricum ZINC SULFATE HEPTAHYDRATE PELLET ORAL 20110103 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ZINC SULFATE HEPTAHYDRATE 30 [hp_C]/1 N 20181231 68428-716_8ac90af9-1490-409e-941a-8ae6a270f341 68428-716 HUMAN OTC DRUG Zincum valerianicum ZINC VALERATE DIHYDRATE PELLET ORAL 20100401 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ZINC VALERATE DIHYDRATE 30 [hp_C]/1 N 20181231 68428-717_459ea4b8-cab1-4047-8b85-d5a98e4646c5 68428-717 HUMAN OTC DRUG Zingiber officinale GINGER PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GINGER 30 [hp_C]/1 N 20181231 68428-718_6ed99730-027c-4a48-ae24-ff28f2a172d0 68428-718 HUMAN OTC DRUG Be gone Bruises and Bumps TM ARNICA MONTANA OINTMENT TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARNICA MONTANA 1 [hp_X]/56g N 20181231 68428-719_46ca6604-96c0-4877-a62d-79ecb01b8500 68428-719 HUMAN OTC DRUG Be gone Cuts and Scrapes TM CALENDULA OFFICINALIS FLOWERING TOP OINTMENT TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/56g N 20181231 68428-720_2a14cb83-4a76-417a-ad28-f4b9647bf124 68428-720 HUMAN OTC DRUG Be gone Minor Arthritic Pain TM ARNICA MONTANA - RHUS TOXICODENDRON - RUTA GRAVEOLENS OINTMENT TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP 3; 3; 3 [hp_X]/56g; [hp_X]/56g; [hp_X]/56g N 20181231 68428-721_1d026dc3-7793-49d7-9d8c-4b5f74e51421 68428-721 HUMAN OTC DRUG Be gone Scars TM THIOSINAMINUM OINTMENT TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALLYLTHIOUREA 2 [hp_X]/56g N 20181231 68428-722_41335180-694e-46e5-89c1-f1f28b911eba 68428-722 HUMAN OTC DRUG Be gone Warts and Tired Feet TM THUJA OCCIDENTALIS OINTMENT TOPICAL 20130315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products THUJA OCCIDENTALIS LEAFY TWIG 1 [hp_X]/56g N 20181231 68428-723_8c7e6ea0-25cd-4879-aa50-96c67f7ab4ba 68428-723 HUMAN OTC DRUG Poison Ivy Pills TOXICODENDRON PUBESCENS LEAF PELLET ORAL 20100824 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TOXICODENDRON PUBESCENS LEAF 4 [hp_X]/28g N 20181231 68428-725_a0ac4ccc-58fb-4929-9cb8-e29b151e9591 68428-725 HUMAN OTC DRUG Be gone Poison Ivy TM TOXICODENDRON PUBESCENS LEAF PELLET ORAL 20130228 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TOXICODENDRON PUBESCENS LEAF 4 [hp_X]/28g N 20181231 68428-726_217a194b-10c1-4770-aa7d-d6f69984909d 68428-726 HUMAN OTC DRUG Be gone Insomnia MATRICARIA RECUTITA - ARABICA COFFEE BEAN - HYOSCYAMUS NIGER - STRYCHNOS IGNATII SEED - STRYCHNOS NUX-VOMICA SEED -PASSIFLORA INCARNATA TOP PELLET ORAL 20130301 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MATRICARIA RECUTITA; ARABICA COFFEE BEAN; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-727_7a74cf98-a923-42d4-9fc6-9f8cfae9ba9c 68428-727 HUMAN OTC DRUG Be gone SCRATCH-N-ITCH TM GRINDELIA SQUARROSA FLOWERING TOP - CAMPHOR (NATURAL) SPRAY TOPICAL 20121101 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GRINDELIA SQUARROSA FLOWERING TOP; CAMPHOR (NATURAL) 1; 1 [hp_X]/60mL; [hp_X]/60mL N 20181231 68428-728_12d1d109-5bc1-4f49-ab5f-e8e35ace49d5 68428-728 HUMAN OTC DRUG WHP Be gone Minor Arthritic Pain TM APIS MELLIFERA, BLACK COHOSH, CALCIUM FLUORIDE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, TOXICODENDRON PUBESCENS LEAF PELLET ORAL 20130228 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products APIS MELLIFERA; BLACK COHOSH; CALCIUM FLUORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-729_e1a2e5bc-58c6-46e2-80d9-daec62b68d33 68428-729 HUMAN OTC DRUG Be gone Motion Sickness TM ANAMIRTA COCCULUS SEED - STRYCHNOS NUX-VOMICA SEED - KEROSENE PELLET ORAL 20130228 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANAMIRTA COCCULUS SEED; STRYCHNOS NUX-VOMICA SEED; KEROSENE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-730_dfd2cb6b-0ff4-42d8-8bdd-43e253cc9c6c 68428-730 HUMAN OTC DRUG Be gone Sinus Congestion TM OYSTER SHELL CALCIUM CARBONATE, CRUDE - GOLDENSEAL - POTASSIUM DICHROMATE PELLET ORAL 20130228 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products OYSTER SHELL CALCIUM CARBONATE, CRUDE; GOLDENSEAL; POTASSIUM DICHROMATE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-731_4de14774-1384-4ee4-89cd-9d42d71e031d 68428-731 HUMAN OTC DRUG Be gone Smoking DIEFFENBACHIA SEGUINE - DAPHNE ODORA BARK - STRYCHNOS NUX-VOMICA SEED - PLANTAGO MAJOR - DELPHINIUM STAPHISAGRIA SEED - TOBACCO LEAF PELLET ORAL 20130301 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIEFFENBACHIA SEGUINE; DAPHNE ODORA BARK; STRYCHNOS NUX-VOMICA SEED; PLANTAGO MAJOR; DELPHINIUM STAPHISAGRIA SEED; TOBACCO LEAF 6; 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-732_c847e490-1e2b-42b7-bea2-1b9579cfcfa1 68428-732 HUMAN OTC DRUG Be gone Stomach Disorders TM SOLANUM DULCAMARA TOP - ACTIVATED CHARCOAL - CHELONE GLABRA - GOLDENSEAL PELLET ORAL 20130311 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SOLANUM DULCAMARA TOP; ACTIVATED CHARCOAL; CHELONE GLABRA; GOLDENSEAL 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-733_79cf3fcd-3060-4a2d-b150-65db810eea10 68428-733 HUMAN OTC DRUG WHP Be gone Dry Eyes TM PULSATILLA VULGARIS - SILICON DIOXIDE - SULFUR PELLET ORAL 20130716 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PULSATILLA VULGARIS; SILICON DIOXIDE; SULFUR 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-734_32c97fd8-d5ae-40d1-ade3-c787bacd13bb 68428-734 HUMAN OTC DRUG WHP Be gone Flu-like Symptoms TM ARSENIC TRIIODIDE - EUPATORIUM PERFOLIATUM FLOWERING TOP - GELSEMIUM SEMPERVIRENS ROOT PELLET ORAL 20130711 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIIODIDE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-735_d945de83-99c0-4533-82e9-6d48c7c876d0 68428-735 HUMAN OTC DRUG WHP Be gone Hay Fever TM ONION - ANTHOXANTHUM ODORATUM - SCHOENOCAULON OFFICINALE SEED PELLET ORAL 20130722 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ONION; ANTHOXANTHUM ODORATUM; SCHOENOCAULON OFFICINALE SEED 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-736_8ba71e76-1845-440d-8dbb-74888dba20fc 68428-736 HUMAN OTC DRUG WHP Be gone Fungus TM GRAPHITE - SEPIA OFFICINALIS JUICE - SULFUR - THUJA OCCIDENTALIS LEAFY TWIG PELLET ORAL 20130726 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GRAPHITE; SEPIA OFFICINALIS JUICE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-737_3b03b58a-c73c-4c24-89d2-2a9a641f0372 68428-737 HUMAN OTC DRUG WHP Be gone Hot Flashes TM AMYL NITRITE - LACHESIS MUTA VENOM - SANGUINARIA CANADENSIS ROOT PELLET ORAL 20130708 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMYL NITRITE; LACHESIS MUTA VENOM; SANGUINARIA CANADENSIS ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-738_b06efeb5-0bd2-4c9b-b234-2b4f6fe124df 68428-738 HUMAN OTC DRUG WHP Be gone Acne TM ANTIMONY TRISULFIDE - MAHONIA AQUIFOLIUM ROOT BARK - LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20130731 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY TRISULFIDE; MAHONIA AQUIFOLIUM ROOT BARK; SEPIA OFFICINALIS JUICE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-739_ca2c08f0-8bcf-4121-b93d-ee5e37cb6bc9 68428-739 HUMAN OTC DRUG WHP Be gone Low Back Pain TM BLACK COHOSH - COLCHICUM AUTUMNALE BULB - POTASSIUM IODIDE PELLET ORAL 20130904 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLACK COHOSH; COLCHICUM AUTUMNALE BULB; POTASSIUM IODIDE 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-740_8bfb97e8-47d8-4c34-bb96-7bb3a6b74d79 68428-740 HUMAN OTC DRUG WHP Be gone Headache TM EPIFAGUS VIRGINIANA - IRIS VERSICOLOR ROOT - POTASSIUM IODIDE PELLET ORAL 20130904 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EPIFAGUS VIRGINIANA; IRIS VERSICOLOR ROOT; STRYCHNOS NUX-VOMICA SEED 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-741_e23be424-6413-4701-ba90-3874fae895fe 68428-741 HUMAN OTC DRUG WHP Be gone Colds and Cough TM ACONITUM NAPELLUS - BRYONIA ALBA ROOT - SANGUINARIA CANADENSIS ROOT PELLET ORAL 20130909 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS; BRYONIA ALBA ROOT; SANGUINARIA CANADENSIS ROOT 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-742_505372bb-0006-445b-8686-17b57640cade 68428-742 HUMAN OTC DRUG WHP Be gone Head Cold TM POTASSIUM MERCURIC IODIDE - GELSEMIUM SEMPERVIRENS ROOT - EUPHRASIA STRICTA PELLET ORAL 20130909 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM MERCURIC IODIDE; GELSEMIUM SEMPERVIRENS ROOT; EUPHRASIA STRICTA 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-743_66524af2-a051-492f-be18-ae95c062861f 68428-743 HUMAN OTC DRUG WHP Be gone Constipation TM CAPSICUM - GOLDENSEAL - CULVERS ROOT - STRYCHNOS NUX-VOMICA SEED - PODOPHYLLUM RESIN PELLET ORAL 20130910 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAPSICUM; GOLDENSEAL; VERONICASTRUM VIRGINICUM ROOT; STRYCHNOS NUX-VOMICA SEED; PODOPHYLLUM RESIN 6; 6; 6; 6; 6 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g N 20181231 68428-744_d1dc460f-ee68-422a-96ae-e77842e50d66 68428-744 HUMAN OTC DRUG WHP Be gone Wheezing TM ARSENIC TRIOXIDE - BLATTA ORIENTALIS - LACHESIS MUTA VENOM PELLET ORAL 20130910 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIOXIDE; BLATTA ORIENTALIS; LACHESIS MUTA VENOM 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-745_4d71b0fe-d9d2-4c93-82a7-eddc1fa66b05 68428-745 HUMAN OTC DRUG WHP Be gone Diarrhea TM ARSENIC TRIOXIDE - CUPRIC ARSENITE - VERATRUM ALBUM ROOT PELLET ORAL 20140508 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIOXIDE; CUPRIC ARSENITE; VERATRUM ALBUM ROOT 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-746_cbd2b212-d2ea-4eb7-9ba3-6e5c80fe9d72 68428-746 HUMAN OTC DRUG WHP Be gone Flatulence TM FERULA ASSA-FOETIDA RESIN, STRYCHNOS IGNATII SEED, NUTMEG PELLET ORAL 20140508 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERULA ASSA-FOETIDA RESIN; STRYCHNOS IGNATII SEED; NUTMEG 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-747_2193909a-ed77-4a94-911f-8d327395b775 68428-747 HUMAN OTC DRUG WHP Be gone Congested Headache TM CALCIUM FLUORIDE - FERROSOFERRIC PHOSPHATE - SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE - SODIUM CHLORIDE PELLET ORAL 20140508 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM CHLORIDE 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-748_3916d2b2-3e7d-4cbd-9d28-135a1cdd7124 68428-748 HUMAN OTC DRUG WHP Be gone Painful Urination TM BERBERIS VULGARIS ROOT BARK - TURPENTINE OIL - LYCOPODIUM CLAVATUM SPORE PELLET ORAL 20140508 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BERBERIS VULGARIS ROOT BARK; TURPENTINE OIL; LYCOPODIUM CLAVATUM SPORE 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-749_3323800d-6584-41fa-95e2-0a0aadcee362 68428-749 HUMAN OTC DRUG WHP Be gone Skin Irritation TM ARSENIC TRIOXIDE - CALCIUM SULFATE ANHYDROUS - SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE - SILICON DIOXIDE PELLET ORAL 20140508 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-862_733afb95-1344-4adf-a336-bff36baaebcc 68428-862 HUMAN OTC DRUG WHP Be gone Teething TM TRIBASIC CALCIUM PHOSPHATE - MATRICARIA CHAMOMILLA - ARABICA COFFEE BEAN PELLET ORAL 20140508 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA; ARABICA COFFEE BEAN 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-863_1bbbfca2-cdd5-4445-b87f-bbee5cf98a9d 68428-863 HUMAN OTC DRUG Acetanilidum ACETANILIDE PELLET ORAL 20120831 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACETANILIDE 30 [hp_C]/1 N 20181231 68428-864_25872dd6-637f-4a7b-97fe-e0a5c96dad6d 68428-864 HUMAN OTC DRUG Aconitum Lycoctonum ACONITUM LYCOCTONUM PELLET ORAL 20111011 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM LYCOCTONUM 30 [hp_C]/1 N 20181231 68428-865_e2160a05-8543-413f-b97a-430462c04d94 68428-865 HUMAN OTC DRUG Aconitum, radix ACONITUM NAPELLUS ROOT PELLET ORAL 20130708 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS ROOT 30 [hp_C]/1 N 20181231 68428-866_09ff8228-1e28-4b49-b21e-982016882d44 68428-866 HUMAN OTC DRUG Adamas DIAMOND PELLET ORAL 20140220 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIAMOND 30 [hp_C]/1 N 20181231 68428-867_82556f8e-d23b-4d41-87c1-d6f2b0f5b68c 68428-867 HUMAN OTC DRUG Aesculus Glabra AESCULUS GLABRA NUT PELLET ORAL 20111205 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AESCULUS GLABRA NUT 30 [hp_C]/1 N 20181231 68428-868_708bd140-fbf5-4429-813f-ce73b96a5143 68428-868 HUMAN OTC DRUG Agaricus phalloides AMANITA PHALLOIDES PELLET ORAL 20110329 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMANITA PHALLOIDES 30 [hp_C]/1 N 20181231 68428-869_0b8fe82e-f8f9-4bc0-b9e7-4e0e3b0f4321 68428-869 HUMAN OTC DRUG Agave americana AGAVE AMERICANA LEAF PELLET ORAL 20140103 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AGAVE AMERICANA LEAF 30 [hp_C]/1 N 20181231 68428-870_4498946a-c823-417e-8431-65d175d0da1c 68428-870 HUMAN OTC DRUG Agraphis nutans HYACINTHOIDES NON-SCRIPTA PELLET ORAL 20120418 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HYACINTHOIDES NON-SCRIPTA 30 [hp_C]/1 N 20181231 68428-871_c84fc468-4230-4f5b-9c39-be1bfbdd2249 68428-871 HUMAN OTC DRUG Agrimonia eupatoria AGRIMONIA EUPATORIA WHOLE PELLET ORAL 20150710 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AGRIMONIA EUPATORIA WHOLE 30 [hp_C]/1 N 20181231 68428-872_d87b455b-79c6-4d11-88ba-4f850ae62f67 68428-872 HUMAN OTC DRUG Alfalfa ALFALFA PELLET ORAL 20110517 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALFALFA 30 [hp_C]/1 N 20181231 68428-873_ac994ce3-737c-4f96-9283-4d4fc57393e9 68428-873 HUMAN OTC DRUG Alloxanum ALLOXAN PELLET ORAL 20150804 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALLOXAN 30 [hp_C]/1 N 20181231 68428-874_ed8fe4d6-104a-49c3-8ae4-b4f4eff0d9e9 68428-874 HUMAN OTC DRUG Alumina silicata KAOLIN PELLET ORAL 20120106 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products KAOLIN 30 [hp_C]/1 N 20181231 68428-875_2334a298-521b-4e0a-9df1-9583bb8b2c7d 68428-875 HUMAN OTC DRUG Ammi visnaga VISNAGA DAUCOIDES FRUIT PELLET ORAL 20130614 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VISNAGA DAUCOIDES FRUIT 30 [hp_C]/1 N 20181231 68428-876_2f6aa615-a55a-4382-900e-ee64693d39b8 68428-876 HUMAN OTC DRUG Ammonium benzoicum AMMONIUM BENZOATE PELLET ORAL 20120926 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM BENZOATE 30 [hp_C]/1 N 20181231 68428-877_38385595-c34e-4af0-b9f1-99e42fd91e3d 68428-877 HUMAN OTC DRUG Ammonium bromatum AMMONIUM BROMIDE PELLET ORAL 20120926 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM BROMIDE 30 [hp_C]/1 N 20181231 68428-878_590d1cab-15cb-4a69-b9b8-875469be2e78 68428-878 HUMAN OTC DRUG Ammonium causticum AMMONIA PELLET ORAL 20110421 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIA 30 [hp_C]/1 N 20181231 68428-879_66a03356-c542-46dd-bfba-12660cbec2e3 68428-879 HUMAN OTC DRUG Ammonium picricum AMMONIUM PICRATE PELLET ORAL 20120404 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM PICRATE 30 [hp_C]/1 N 20181231 68428-880_02cb6892-6d63-4960-8502-837dd7b23eec 68428-880 HUMAN OTC DRUG Ammonium valerianicum AMMONIUM VALERATE PELLET ORAL 20121129 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM VALERATE 30 [hp_C]/1 N 20181231 68428-881_40ca1e59-c6de-4187-b082-818d1524ab6f 68428-881 HUMAN OTC DRUG Ampelopsis quinquefolia PARTHENOCISSUS QUINQUEFOLIA LEAF PELLET ORAL 20131031 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PARTHENOCISSUS QUINQUEFOLIA LEAF 30 [hp_C]/1 N 20181231 68428-882_4af49ee7-f00a-4bb5-84a0-88290c7d6bd2 68428-882 HUMAN OTC DRUG Anagallis arvensis ANAGALLIS ARVENSIS PELLET ORAL 20110527 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANAGALLIS ARVENSIS 30 [hp_C]/1 N 20181231 68428-883_a16d2e99-1916-41ab-9f0c-a7111b46ee58 68428-883 HUMAN OTC DRUG Angelica sinensis, radix ANGELICA SINENSIS ROOT PELLET ORAL 20150612 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANGELICA SINENSIS ROOT 30 [hp_C]/1 N 20181231 68428-884_f65019f9-9a22-4c97-94d2-087f45a7d40d 68428-884 HUMAN OTC DRUG Antimonium iodatum ANTIMONY TRIIODIDE PELLET ORAL 20120518 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY TRIIODIDE 30 [hp_C]/1 N 20181231 68428-885_820b94e5-4258-4612-a255-78fd52c21244 68428-885 HUMAN OTC DRUG Aqua marina SODIUM CHLORIDE PELLET ORAL 20110707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM CHLORIDE 30 [hp_C]/1 N 20181231 68428-886_fccdfde9-e626-45de-9be2-2ae299497c50 68428-886 HUMAN OTC DRUG Aquilegia vulgaris AQUILEGIA VULGARIS PELLET ORAL 20110421 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AQUILEGIA VULGARIS 30 [hp_C]/1 N 20181231 68428-887_99d100fd-c926-4fc5-8aeb-69d34d8c6215 68428-887 HUMAN OTC DRUG Aralia quinquefolia AMERICAN GINSENG PELLET ORAL 20151016 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMERICAN GINSENG 30 [hp_C]/1 N 20181231 68428-888_7c75b3ff-de0c-449b-baa0-618d0a84c992 68428-888 HUMAN OTC DRUG Aranea diadema ARANEUS DIADEMATUS PELLET ORAL 20110727 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARANEUS DIADEMATUS 30 [hp_C]/1 N 20181231 68428-889_afc409e2-fec5-4a70-8e9b-7b7e594f4efe 68428-889 HUMAN OTC DRUG Arbutus andrachne ARBUTUS ANDRACHNE LEAFY SHOOT PELLET ORAL 20140319 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARBUTUS ANDRACHNE LEAFY SHOOT 30 [hp_C]/1 N 20181231 68428-890_6d18e50d-029b-432b-a754-65be46c0b723 68428-890 HUMAN OTC DRUG Argentum muriaticum SILVER CHLORIDE PELLET ORAL 20151030 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SILVER CHLORIDE 30 [hp_C]/1 N 20181231 68428-891_88987f88-b473-4830-9957-32e7cc3c7265 68428-891 HUMAN OTC DRUG Arsenicum metallicum ARSENIC PELLET ORAL 20131205 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC 30 [hp_C]/1 N 20181231 68428-892_f43dbeb7-abff-4363-8112-f178af218cb2 68428-892 HUMAN OTC DRUG Artemisia vulgaris ARTEMISIA VULGARIS ROOT PELLET ORAL 20110406 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARTEMISIA VULGARIS ROOT 30 [hp_C]/1 N 20181231 68428-893_c7ab1de6-725d-4afb-a154-e417201c044f 68428-893 HUMAN OTC DRUG Astragalus menziesii ASTRAGALUS NUTTALLII LEAF PELLET ORAL 20140618 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASTRAGALUS NUTTALLII LEAF 30 [hp_C]/1 N 20181231 68428-894_0ff761be-2d5c-4472-b724-e28ce604589c 68428-894 HUMAN OTC DRUG Balsamum peruvianum BALSAM PERU PELLET ORAL 20110421 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BALSAM PERU 30 [hp_C]/1 N 20181231 68428-895_8c8f7806-39a2-4079-a073-2e569c923803 68428-895 HUMAN OTC DRUG Baryta acetica BARIUM ACETATE PELLET ORAL 20160405 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BARIUM ACETATE 30 [hp_C]/1 N 20181231 68428-896_fb08bff5-0a07-49bd-ac75-205067b3d9aa 68428-896 HUMAN OTC DRUG Beryllium metallicum BERYLLIUM PELLET ORAL 20120611 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BERYLLIUM 30 [hp_C]/1 N 20181231 68428-897_45949442-5e37-42b7-9c74-5bfb835cfd1f 68428-897 HUMAN OTC DRUG Betula pendula, cortex BETULA PENDULA BARK PELLET ORAL 20121127 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BETULA PENDULA BARK 30 [hp_C]/1 N 20181231 68428-898_d10d79ec-7cc2-430c-80da-2584c9b5c0d9 68428-898 HUMAN OTC DRUG Bismuthum subnitricum BISMUTH SUBNITRATE PELLET ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BISMUTH SUBNITRATE 30 [hp_C]/1 N 20181231 68428-899_4dd33f6c-4591-4cf0-9dca-ed8623c054e9 68428-899 HUMAN OTC DRUG Brassica napas BRASSICA NAPUS SUBSP. NAPUS PELLET ORAL 20150710 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BRASSICA NAPUS SUBSP. NAPUS 30 [hp_C]/1 N 20181231 68428-900_eed36875-9b66-48ee-8901-e9d822d8e3d6 68428-900 HUMAN OTC DRUG Cacao COCOA PELLET ORAL 20130322 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COCOA 30 [hp_C]/1 N 20181231 68428-901_e35b6644-c6ac-4318-afd4-edbc51dfbb57 68428-901 HUMAN OTC DRUG Cadmium bromatum CADMIUM BROMIDE PELLET ORAL 20100615 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CADMIUM BROMIDE 30 [hp_C]/1 N 20181231 68428-902_593a97d2-c8e4-4019-8563-15c84ea7935b 68428-902 HUMAN OTC DRUG Cadmium metallicum CADMIUM PELLET ORAL 20110404 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CADMIUM 30 [hp_C]/1 N 20181231 68428-903_137b26d5-661c-4828-ad87-bd17e7d9c1df 68428-903 HUMAN OTC DRUG Calcarea acetica CADMIUM PELLET ORAL 20140521 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM ACETATE 30 [hp_C]/1 N 20181231 68428-904_c90deb8d-5606-40cd-acbb-a06e5b4287cd 68428-904 HUMAN OTC DRUG Calcarea muriatica CALCIUM CHLORIDE PELLET ORAL 20120125 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM CHLORIDE 30 [hp_C]/1 N 20181231 68428-905_97500256-2ed1-45ae-b10f-545002e6c197 68428-905 HUMAN OTC DRUG Calcarea silicata CALCIUM SILICATE PELLET ORAL 20120713 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM SILICATE 30 [hp_C]/1 N 20181231 68428-906_2e423525-e444-42ff-9157-f5535e05380a 68428-906 HUMAN OTC DRUG Candida parapsilosis CANDIDA PARAPSILOSIS PELLET ORAL 20130226 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CANDIDA PARAPSILOSIS 30 [hp_C]/1 N 20181231 68428-907_d27cae1e-9cc2-487b-8930-d72812cf6dd2 68428-907 HUMAN OTC DRUG Carbo animalis CARBO ANIMALIS LIQUID ORAL 20100513 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CARBO ANIMALIS 30 [hp_C]/mL N 20181231 68428-908_fcdec56e-a2ec-472e-b386-d287a815fdc8 68428-908 HUMAN OTC DRUG Carboneum D and C BLACK NO. 2 PELLET ORAL 20151015 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products D&C BLACK NO. 2 30 [hp_C]/1 N 20181231 68428-909_f316ee42-e794-4849-8488-34912410f7bd 68428-909 HUMAN OTC DRUG Carduus benedictus CENTAUREA BENEDICTA PELLET ORAL 20121121 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CENTAUREA BENEDICTA 30 [hp_C]/1 N 20181231 68428-910_7de47cd4-81d8-4a76-87ad-41c968b5ffb6 68428-910 HUMAN OTC DRUG Castoreum CASTOR CANADENSIS SCENT GLAND SECRETION PELLET ORAL 20120323 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CASTOR CANADENSIS SCENT GLAND SECRETION 30 [hp_C]/1 N 20181231 68428-911_d96e3e47-5b6b-4f7d-b8b7-975ea82bde3b 68428-911 HUMAN OTC DRUG Cephalanthus occidentalis CEPHALANTHUS OCCIDENTALIS BARK PELLET ORAL 20131212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CEPHALANTHUS OCCIDENTALIS BARK 30 [hp_C]/1 N 20181231 68428-913_87b5b176-7360-4e82-af94-67d38be97c33 68428-913 HUMAN OTC DRUG Chenopodium vulvaria CHENOPODIUM VULVARIA PELLET ORAL 20120221 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHENOPODIUM VULVARIA 30 [hp_C]/1 N 20181231 68428-914_0794385e-a1fa-429d-b759-ac8d3ee00d4f 68428-914 HUMAN OTC DRUG Chromium oxydatum CHROMIC OXIDE PELLET ORAL 20110727 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHROMIC OXIDE 30 [hp_C]/1 N 20181231 68428-915_3b945609-b3b1-4c9b-b54d-190d927777bd 68428-915 HUMAN OTC DRUG Chromium sulphuricum CHROMIC SULFATE PENTADECAHYDRATE PELLET ORAL 20160202 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHROMIC SULFATE PENTADECAHYDRATE 30 [hp_C]/1 N 20181231 68428-916_c4082bb8-eebd-4b73-9710-dff3f7a95742 68428-916 HUMAN OTC DRUG Cimex lectularius CIMEX LECTULARIUS PELLET ORAL 20130201 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CIMEX LECTULARIUS 30 [hp_C]/1 N 20181231 68428-917_02d987e2-7e83-45fc-ae75-6de1e7a9f2a2 68428-917 HUMAN OTC DRUG Cobaltum nitricum COBALTOUS NITRATE HEXAHYDRATE PELLET ORAL 20111221 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COBALTOUS NITRATE HEXAHYDRATE 30 [hp_C]/1 N 20181231 68428-918_74e0e6ca-139f-4741-9cbc-b73148392528 68428-918 HUMAN OTC DRUG Cochlearia armoracia HORSERADISH PELLET ORAL 20130627 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HORSERADISH 30 [hp_C]/1 N 20181231 68428-919_385b330f-b4d9-46bb-88e8-02debaebfa0e 68428-919 HUMAN OTC DRUG Cochlearia officinalis COCHLEARIA OFFICINALIS FLOWERING TOP PELLET ORAL 20131212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COCHLEARIA OFFICINALIS FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-920_df79bf00-1c64-4507-932c-5004f8e083cb 68428-920 HUMAN OTC DRUG Colibacillinum cum natrum muriaticum ESCHERICHIA COLI PELLET ORAL 20121026 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ESCHERICHIA COLI 30 [hp_C]/1 N 20181231 68428-921_b3641b79-fe63-45d5-af73-03a393865942 68428-921 HUMAN OTC DRUG Convolvulus arvensis CONVOLVULUS ARVENSIS PELLET ORAL 20111012 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CONVOLVULUS ARVENSIS 30 [hp_C]/1 N 20181231 68428-922_e1b32354-8a4a-4c91-beaa-ebbd7928f316 68428-922 HUMAN OTC DRUG Copaiva officinalis COPAIFERA OFFICINALIS RESIN PELLET ORAL 20120221 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COPAIFERA OFFICINALIS RESIN 30 [hp_C]/1 N 20181231 68428-923_0267b49a-5940-483e-a209-d4bf8ad17496 68428-923 HUMAN OTC DRUG Coriaria ruscifolia CORIARIA RUSCIFOLIA FRUIT PELLET ORAL 20150730 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CORIARIA RUSCIFOLIA FRUIT 30 [hp_C]/1 N 20181231 68428-924_b8406d39-47d3-49ee-bb8f-924a9c2a68b0 68428-924 HUMAN OTC DRUG Crotalus cascavella CROTALUS DURISSUS TERRIFICUS VENOM PELLET ORAL 20130605 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CROTALUS DURISSUS TERRIFICUS VENOM 30 [hp_C]/1 N 20181231 68428-925_8bf8b247-0a11-4cd2-9b72-d109e56be212 68428-925 HUMAN OTC DRUG Cubeba officinalis PIPER CUBEBA FRUIT PELLET ORAL 20121129 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PIPER CUBEBA FRUIT 30 [hp_C]/1 N 20181231 68428-926_8b8c0037-d9b2-4f81-b77d-f26c9c5443e5 68428-926 HUMAN OTC DRUG Culex musca CULEX PIPIENS PELLET ORAL 20120509 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CULEX PIPIENS 30 [hp_C]/1 N 20181231 68428-927_db89bce3-45c4-40e0-b1bc-333e11019327 68428-927 HUMAN OTC DRUG Cupressus lawsoniana CHAMAECYPARIS LAWSONIANA FRUITING TWIG PELLET ORAL 20120625 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHAMAECYPARIS LAWSONIANA FRUITING TWIG 30 [hp_C]/1 N 20181231 68428-928_b2c14222-58d0-4d1d-a8ab-32e870a78d05 68428-928 HUMAN OTC DRUG Cuprum aceticum CUPRIC ACETATE PELLET ORAL 20120904 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CUPRIC ACETATE 30 [hp_C]/1 N 20181231 68428-929_b01bc4e8-85b4-409b-a819-43fa3ff6f957 68428-929 HUMAN OTC DRUG Cynara scolymus CYNARA SCOLYMUS LEAF PELLET ORAL 20160308 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CYNARA SCOLYMUS LEAF 30 [hp_C]/1 N 20181231 68428-930_ab39f1b7-a946-40fd-bbe5-fc75a57aa46b 68428-930 HUMAN OTC DRUG Cytisus scoparius CYTISUS SCOPARIUS FLOWERING TOP PELLET ORAL 20130523 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CYTISUS SCOPARIUS FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-931_9864a00b-6172-4286-80c3-1648ff4d394b 68428-931 HUMAN OTC DRUG Derris pinnata DALBERGIA PINNATA ROOT PELLET ORAL 20130523 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DALBERGIA PINNATA ROOT 30 [hp_C]/1 N 20181231 68428-932_32d5f5ed-2bd0-4920-859a-b334b8139be4 68428-932 HUMAN OTC DRUG Dichapetalum DICHAPETALUM MADAGASCARIENSE BARK/LEAF PELLET ORAL 20140122 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DICHAPETALUM MADAGASCARIENSE BARK/LEAF 30 [hp_C]/1 N 20181231 68428-933_eef10eb8-425d-45d4-ae2d-ebc0e0c00524 68428-933 HUMAN OTC DRUG Digitalinum DIGITALIN PELLET ORAL 20110526 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIGITALIN 30 [hp_C]/1 N 20181231 68428-934_3726b468-a5b1-46aa-b346-28ba414a3edb 68428-934 HUMAN OTC DRUG Dolichos pruriens MUCUNA PRURIENS FRUIT TRICHOME PELLET ORAL 20110624 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MUCUNA PRURIENS FRUIT TRICHOME 30 [hp_C]/1 N 20181231 68428-935_45ffb74b-6a1d-40ff-b152-d541bac387b6 68428-935 HUMAN OTC DRUG Duboisia myoporoides DUBOISIA MYOPOROIDES LEAF PELLET ORAL 20150908 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DUBOISIA MYOPOROIDES LEAF 30 [hp_C]/1 N 20181231 68428-936_f8f30f88-c487-473f-bb63-7a3c643ebaec 68428-936 HUMAN OTC DRUG Erechtites hieracifolia ERECHTITES HIERACIIFOLIUS PELLET ORAL 20140122 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ERECHTITES HIERACIIFOLIUS 30 [hp_C]/1 N 20181231 68428-937_e61dfd2b-5a9f-4d88-a430-50794bdd0635 68428-937 HUMAN OTC DRUG Eupatorium purp EUTROCHIUM PURPUREUM ROOT PELLET ORAL 20111025 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUTROCHIUM PURPUREUM ROOT 30 [hp_C]/1 N 20181231 68428-938_08d04fb2-b1c5-4945-afa6-aa5572f5fb83 68428-938 HUMAN OTC DRUG Euphorbia pilulifera EUPHORBIA HIRTA FLOWERING TOP PELLET ORAL 20121129 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPHORBIA HIRTA FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-939_2794ca97-e800-45dd-9748-1af9a2388042 68428-939 HUMAN OTC DRUG Euphorbium officinarum EUPHORBIA RESINIFERA RESIN PELLET ORAL 20100517 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPHORBIA RESINIFERA RESIN 30 [hp_C]/1 N 20181231 68428-940_e9c04cea-6be3-4e4f-bc88-5dde8f6ca46c 68428-940 HUMAN OTC DRUG Fagus sylvatica FAGUS SYLVATICA FLOWERING TOP PELLET ORAL 20131212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FAGUS SYLVATICA FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-941_059707d9-17e0-4d03-a126-0e4281759fef 68428-941 HUMAN OTC DRUG Ferrum sulphuricum FERROUS SULFATE PELLET ORAL 20110614 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERROUS SULFATE 30 [hp_C]/1 N 20181231 68428-942_9b5b0a31-3a86-4971-8f46-e93cbda4ce3c 68428-942 HUMAN OTC DRUG Foeniculum vulgare FENNEL SEED PELLET ORAL 20131212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FENNEL SEED 30 [hp_C]/1 N 20181231 68428-943_cf917cbb-c159-47f7-8a53-9f8317da456d 68428-943 HUMAN OTC DRUG Franciscea uniflora BRUNFELSIA UNIFLORA ROOT PELLET ORAL 20160208 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BRUNFELSIA UNIFLORA ROOT 30 [hp_C]/1 N 20181231 68428-944_b4dca049-6bfa-4113-b625-20ad7cc53e27 68428-944 HUMAN OTC DRUG Fucus vesiculosus FUCUS VESICULOSUS PELLET ORAL 20130925 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FUCUS VESICULOSUS 30 [hp_C]/1 N 20181231 68428-945_f3b9cece-6572-4395-957a-719c118e5ee5 68428-945 HUMAN OTC DRUG Gentiana lutea GENTIANA LUTEA ROOT PELLET ORAL 20110817 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GENTIANA LUTEA ROOT 30 [hp_C]/1 N 20181231 68428-946_3c8f85f2-5e1b-427e-821c-b56fcc890206 68428-946 HUMAN OTC DRUG Glycyrrhiza glabra GLYCYRRHIZA GLABRA PELLET ORAL 20120613 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GLYCYRRHIZA GLABRA 30 [hp_C]/1 N 20181231 68428-947_ccf7329c-1e2d-4f0a-86c0-297cacd86821 68428-947 HUMAN OTC DRUG Gratiola officinalis GRATIOLA OFFICINALIS PELLET ORAL 20130227 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GRATIOLA OFFICINALIS 30 [hp_C]/1 N 20181231 68428-948_5bdb4102-b8ec-43ee-9c0a-9c9816173be3 68428-948 HUMAN OTC DRUG Guatteria gaumeri MALMEA DEPRESSA BARK PELLET ORAL 20131230 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MALMEA DEPRESSA BARK 30 [hp_C]/1 N 20181231 68428-949_787dac5b-55d8-4714-b560-5fcb86a5048a 68428-949 HUMAN OTC DRUG Helix tosta ESCARGOT SHELL, COOKED PELLET ORAL 20121129 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ESCARGOT SHELL, COOKED 30 [hp_C]/1 N 20181231 68428-950_64a3458c-6058-41cc-83bf-fe0285dc310c 68428-950 HUMAN OTC DRUG Heloderma HELODERMA HORRIDUM VENOM PELLET ORAL 20111116 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HELODERMA HORRIDUM VENOM 30 [hp_C]/1 N 20181231 68428-952_eaa43e0e-03d9-47a7-89db-4d9e43fdc949 68428-952 HUMAN OTC DRUG Hippuricum acidum HIPPURIC ACID PELLET ORAL 20140122 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HIPPURIC ACID 30 [hp_C]/1 N 20181231 68428-953_9b814732-c1ae-4cb0-90ff-94b105a5f7b0 68428-953 HUMAN OTC DRUG Homarus gam HOMARUS AMERICANUS DIGESTIVE FLUID PELLET ORAL 20120326 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HOMARUS AMERICANUS DIGESTIVE FLUID 30 [hp_C]/1 N 20181231 68428-954_e58e3ae7-0b2b-4b6f-bbd4-678e20526810 68428-954 HUMAN OTC DRUG Humulus lupulus HOPS PELLET ORAL 20130208 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HOPS 30 [hp_C]/1 N 20181231 68428-955_2e2deccc-51bb-4f44-820d-38a497ebf04c 68428-955 HUMAN OTC DRUG Hydrocyanicum acidum HYDROGEN CYANIDE PELLET ORAL 20160610 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HYDROGEN CYANIDE 30 [hp_C]/1 N 20181231 68428-956_249c9c79-2f5c-4acd-a09c-a7acfbd8f98a 68428-956 HUMAN OTC DRUG Ichthyolum ICHTHAMMOL PELLET ORAL 20110421 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ICHTHAMMOL 30 [hp_C]/1 N 20181231 68428-957_8dfacf26-6882-4eda-b1f3-efa7e99a280e 68428-957 HUMAN OTC DRUG Ilex paraguariensis ILEX PARAGUARIENSIS LEAF PELLET ORAL 20140127 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ILEX PARAGUARIENSIS LEAF 30 [hp_C]/1 N 20181231 68428-958_e91cd67b-71d7-4702-b6ba-8a0ad02c6f66 68428-958 HUMAN OTC DRUG Imperatoria ostruthium IMPERATORIA OSTRUTHIA ROOT PELLET ORAL 20131230 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IMPERATORIA OSTRUTHIA ROOT 30 [hp_C]/1 N 20181231 68428-959_60ebf70e-b848-452f-a869-7fde87856b4f 68428-959 HUMAN OTC DRUG Iodoformum IODOFORM PELLET ORAL 20150828 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IODOFORM 30 [hp_C]/1 N 20181231 68428-960_d90c4ad0-64b8-40b4-89ce-96c7e3ef05b3 68428-960 HUMAN OTC DRUG Iris tenax IRIS TENAX PELLET ORAL 20140320 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IRIS TENAX 30 [hp_C]/1 N 20181231 68428-961_34dc07ee-0e41-4f78-91a7-285c70f600e7 68428-961 HUMAN OTC DRUG Jacaranda caroba JACARANDA CAROBA FLOWER PELLET ORAL 20150529 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products JACARANDA CAROBA FLOWER 30 [hp_C]/1 N 20181231 68428-962_b443b683-5227-45a3-b581-aec8f978729e 68428-962 HUMAN OTC DRUG Jalapa IPOMOEA PURGA ROOT PELLET ORAL 20150527 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IPOMOEA PURGA ROOT 30 [hp_C]/1 N 20181231 68428-963_613ea30c-483a-4903-8a35-9af45c35f91c 68428-963 HUMAN OTC DRUG Juniperus communis JUNIPER BERRY PELLET ORAL 20110401 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products JUNIPER BERRY 30 [hp_C]/1 N 20181231 68428-964_34c5719b-2870-42d6-ac8a-a4ff9d95a0f7 68428-964 HUMAN OTC DRUG Kali cyanatum POTASSIUM CYANIDE PELLET ORAL 20150725 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM CYANIDE 30 [hp_C]/1 N 20181231 68428-965_a466be22-242b-4bb4-82c8-dcca94501f1b 68428-965 HUMAN OTC DRUG Kali permanganicum POTASSIUM PERMANGANATE PELLET ORAL 20150727 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM PERMANGANATE 30 [hp_C]/1 N 20181231 68428-966_4abf1e41-8f6b-4501-a8ca-fc323633f785 68428-966 HUMAN OTC DRUG Kali silicatum POTASSIUM SILICATE PELLET ORAL 20150727 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM SILICATE 30 [hp_C]/1 N 20181231 68428-967_2aca2d2c-3a26-4417-8aa4-039ba7d210b0 68428-967 HUMAN OTC DRUG Karwinskia humboldtiana KARWINSKIA HUMBOLDTIANA SEED PELLET ORAL 20121129 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products KARWINSKIA HUMBOLDTIANA SEED 30 [hp_C]/1 N 20181231 68428-968_016eb802-e117-4712-af9a-cf23683c69ce 68428-968 HUMAN OTC DRUG Laburnum anagyroides LABURNUM ANAGYROIDES FLOWERING TOP PELLET ORAL 20110524 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LABURNUM ANAGYROIDES FLOWERING TOP 30 [hp_C]/1 N 20181231 68428-969_dbde33e4-e5f0-4291-b7c1-94ec1eed575c 68428-969 HUMAN OTC DRUG Lac felinum FELIS CATUS MILK PELLET ORAL 20110707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FELIS CATUS MILK 30 [hp_C]/1 N 20181231 68428-970_765a9082-b030-4299-9cb5-f5c4af57c271 68428-970 HUMAN OTC DRUG Laurocerasus PRUNUS LAUROCERASUS LEAF PELLET ORAL 20110419 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PRUNUS LAUROCERASUS LEAF 30 [hp_C]/1 N 20181231 68428-971_e4ac2322-b8a7-421c-b5a6-0dd01ab3d4e9 68428-971 HUMAN OTC DRUG Lemna minor LEMNA MINOR PELLET ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEMNA MINOR 30 [hp_C]/1 N 20181231 68428-972_73c77151-7dfa-4333-8f80-8654371bc75d 68428-972 HUMAN OTC DRUG Liatris spicata LIATRIS SPICATA ROOT PELLET ORAL 20131230 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LIATRIS SPICATA ROOT 30 [hp_C]/1 N 20181231 68428-973_8ceaa69e-b687-494b-a20a-ff80a3ea3e86 68428-973 HUMAN OTC DRUG Linaria vulgaris LINARIA VULGARIS PELLET ORAL 20120601 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LINARIA VULGARIS 30 [hp_C]/1 N 20181231 68428-974_247d5dcd-1ed0-49fa-a130-7be3c3f99338 68428-974 HUMAN OTC DRUG Lithium bromatum LITHIUM BROMIDE PELLET ORAL 20110727 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LITHIUM BROMIDE 30 [hp_C]/1 N 20181231 68428-975_5db768e5-87d9-4158-9fd2-b26da6689631 68428-975 HUMAN OTC DRUG Lithium muriaticum LITHIUM CHLORIDE PELLET ORAL 20111104 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LITHIUM CHLORIDE 30 [hp_C]/1 N 20181231 68428-976_2aa44f5d-ffcb-4e55-8020-349f1aec99fd 68428-976 HUMAN OTC DRUG Lolium temulentum LOLIUM TEMULENTUM TOP PELLET ORAL 20130625 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LOLIUM TEMULENTUM TOP 30 [hp_C]/1 N 20181231 68428-977_2d964ee2-b6ad-4b3e-9e7a-d5a069eb1914 68428-977 HUMAN OTC DRUG Lonicera periclymenum LONICERA PERICLYMENUM FLOWERING TWIG PELLET ORAL 20130129 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LONICERA PERICLYMENUM FLOWERING TWIG 30 [hp_C]/1 N 20181231 68428-978_9b86f1ff-77a7-4e91-b4fb-6c992d0181f3 68428-978 HUMAN OTC DRUG Lycopersicum esculentum SOLANUM LYCOPERSICUM PELLET ORAL 20120404 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SOLANUM LYCOPERSICUM 30 [hp_C]/1 N 20181231 68428-979_d2316874-e3ca-4c35-a620-9b5bca9b29e3 68428-979 HUMAN OTC DRUG Macrotinum BLACK COHOSH PELLET ORAL 20120615 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLACK COHOSH 30 [hp_C]/1 N 20181231 68428-980_98f1b31f-3727-45b2-aef2-a89bf8c8508d 68428-980 HUMAN OTC DRUG Magnesia sulphurica MAGNESIUM SULFATE HEPTAHYDRATE PELLET ORAL 20110627 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MAGNESIUM SULFATE HEPTAHYDRATE 30 [hp_C]/1 N 20181231 68428-981_f66824cf-f8b0-4a71-b798-821343c5a77b 68428-981 HUMAN OTC DRUG Magnesium metallicum MAGNESIUM PELLET ORAL 20111013 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MAGNESIUM 30 [hp_C]/1 N 20181231 68428-982_d3964861-b37f-43f8-b55e-bc31641849e3 68428-982 HUMAN OTC DRUG Magnolia grandiflora MAGNOLIA GRANDIFLORA FLOWER PELLET ORAL 20110707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MAGNOLIA GRANDIFLORA FLOWER 30 [hp_C]/1 N 20181231 68428-983_bfb293ec-888c-496d-a5f2-8b8febb71716 68428-983 HUMAN OTC DRUG WHP Be gone SCRATCH-N-ITCH TM GRINDELIA SQUARROSA FLOWERING TOP - CAMPHOR (NATURAL) SPRAY TOPICAL 20130802 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GRINDELIA SQUARROSA FLOWERING TOP; CAMPHOR (NATURAL) 1; 3 [hp_X]/60mL; [hp_X]/60mL N 20181231 68428-984_f382ac89-6e27-4dc2-8ced-49217143e814 68428-984 HUMAN OTC DRUG Manganum carbonicum MANGANESE CARBONATE PELLET ORAL 20130807 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MANGANESE CARBONATE 30 [hp_C]/1 N 20181231 68428-985_0969c6a2-033e-450d-96f6-c4420b29370c 68428-985 HUMAN OTC DRUG Marrubium vulgare MARRUBIUM VULGARE PELLET ORAL 20140221 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MARRUBIUM VULGARE 30 [hp_C]/1 N 20181231 68428-986_0c174905-cdcd-4a47-9e28-5c8aa94139d3 68428-986 HUMAN OTC DRUG Menyanthes trifoliata MENYANTHES TRIFOLIATA PELLET ORAL 20120125 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MENYANTHES TRIFOLIATA 30 [hp_C]/1 N 20181231 68428-987_c90c2e14-6019-414b-ba8e-ea97709586ec 68428-987 HUMAN OTC DRUG Mephitis mephitica MEPHITIS MEPHITIS ANAL GLAND FLUID PELLET ORAL 20120601 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MEPHITIS MEPHITIS ANAL GLAND FLUID 30 [hp_C]/1 N 20181231 68428-988_d7022a8a-6df5-4673-abc8-037891af1680 68428-988 HUMAN OTC DRUG Mercurius cyanatus MERCURIC CYANIDE PELLET ORAL 20120125 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURIC CYANIDE 30 [hp_C]/1 N 20181231 68428-989_19237b74-387a-4f9b-a1f9-0fe0250fc9f8 68428-989 HUMAN OTC DRUG Mercurius praecipitatus ruber MERCURIC OXIDE PELLET ORAL 20120611 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MERCURIC OXIDE 30 [hp_C]/1 N 20181231 68428-990_ea292449-736b-4619-b733-da224daaa03d 68428-990 HUMAN OTC DRUG Morbillinum MEASLES VIRUS PELLET ORAL 20110615 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MEASLES VIRUS 30 [hp_C]/1 N 20181231 68428-991_f2a9f8c9-95a8-44c2-be5c-5be6e242f538 68428-991 HUMAN OTC DRUG Myrrha MYRRH PELLET ORAL 20121109 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MYRRH 30 [hp_C]/1 N 20181231 68428-992_a7230a66-b046-4d98-b02e-b6946767a2e7 68428-992 HUMAN OTC DRUG Nasturtium aquaticum NASTURTIUM OFFICINALE PELLET ORAL 20130524 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NASTURTIUM OFFICINALE 30 [hp_C]/1 N 20181231 68428-993_39269ff1-5f7d-4505-8977-0a4e4fabac99 68428-993 HUMAN OTC DRUG Natrum hypochlorosum SODIUM HYPOCHLORITE PELLET ORAL 20120601 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM HYPOCHLORITE 30 [hp_C]/1 N 20181231 68428-994_ebdf1358-009c-44d1-a4bd-87295510bf68 68428-994 HUMAN OTC DRUG Negundo ACER NEGUNDO ROOT BARK PELLET ORAL 20140212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACER NEGUNDO ROOT BARK 30 [hp_C]/1 N 20181231 68428-995_a7fe3d46-3be3-419a-a00b-744af6924043 68428-995 HUMAN OTC DRUG Nitrogenum oxygenatum NITROUS OXIDE PELLET ORAL 20110524 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NITROUS OXIDE 30 [hp_C]/1 N 20181231 68428-996_6b4e33c5-49c1-4cd7-a107-716af03a9011 68428-996 HUMAN OTC DRUG Nymphaea odorata NYMPHAEA ODORATA ROOT PELLET ORAL 20140122 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NYMPHAEA ODORATA ROOT 30 [hp_C]/1 N 20181231 68428-997_52885602-e642-444a-a75c-a532f6fdc2e9 68428-997 HUMAN OTC DRUG WHP Be gone Hangover TM ACTIVATED CHARCOAL, ARABICA COFFEE BEAN, IPECAC, STRYCHNOS NUX-VOMICA SEED PELLET ORAL 20160513 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACTIVATED CHARCOAL; ARABICA COFFEE BEAN; IPECAC; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-998_9630bf23-14c7-4aef-9e55-e085efef2564 68428-998 HUMAN OTC DRUG WHP Be gone Stings TM APIS MELLIFERA, ARABICA COFFEE BEAN, IPECAC, STRYCHNOS NUX-VOMICA SEED PELLET ORAL 20160513 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products APIS MELLIFERA; HYPERICUM PERFORATUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; URTICA URENS 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68428-999_aa1d9277-0a2e-4039-be3f-17a4eaadffed 68428-999 HUMAN OTC DRUG WHP Be gone Stress TM HELIANTHEMUM NUMMULARIUM FLOWER, IMPATIENS GLANDULIFERA FLOWER, OLEA EUROPAEA FLOWER, ORNITHOGALUM UMBELLATUM FLOWERING TOP, PRUNUS CERASIFERA FLOWER PELLET ORAL 20160513 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER 5; 5; 5; 5; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 68436-120_304f1d5a-218d-51ae-e054-00144ff88e88 68436-120 HUMAN OTC DRUG Sorbutuss NR Sorbutuss LIQUID ORAL 20070101 OTC MONOGRAPH FINAL part341 Teral Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL E 20171231 68437-010_4d6d0a50-40fe-4366-9f26-331fe901ae4f 68437-010 HUMAN OTC DRUG Sulfur Sulfur OINTMENT TOPICAL 20121201 OTC MONOGRAPH FINAL part333D GRISI Hnos, S.A DE C.V SULFUR 10 g/100g N 20181231 68437-011_054206cd-c5ee-41c2-a2d8-6cde28fcb08b 68437-011 HUMAN OTC DRUG Sulfur Sulfur SOAP TOPICAL 20121201 OTC MONOGRAPH FINAL part333D GRISI Hnos, S.A DE C.V SULFUR 10 g/100g N 20181231 68462-101_28b8c9f9-b7f9-42c4-8595-ab343ba4612d 68462-101 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Glenmark Pharmaceuticals Inc., USA FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68462-102_28b8c9f9-b7f9-42c4-8595-ab343ba4612d 68462-102 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Glenmark Pharmaceuticals Inc., USA FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68462-103_28b8c9f9-b7f9-42c4-8595-ab343ba4612d 68462-103 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Glenmark Pharmaceuticals Inc., USA FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68462-104_28b8c9f9-b7f9-42c4-8595-ab343ba4612d 68462-104 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Glenmark Pharmaceuticals Inc., USA FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68462-105_c76453ea-1300-4dd1-ba98-0bf17ce8a30d 68462-105 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077535 Glenmark Pharmaceuticals Inc., USA ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68462-106_c76453ea-1300-4dd1-ba98-0bf17ce8a30d 68462-106 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077535 Glenmark Pharmaceuticals Inc., USA ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68462-108_3e2ca87d-2ea5-462f-b992-0f45b457a43c 68462-108 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Glenmark Pharmaceuticals Inc., USA TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68462-109_3e2ca87d-2ea5-462f-b992-0f45b457a43c 68462-109 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Glenmark Pharmaceuticals Inc., USA TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68462-110_3e2ca87d-2ea5-462f-b992-0f45b457a43c 68462-110 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Glenmark Pharmaceuticals Inc., USA TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68462-112_9a03e97e-ec9e-4e14-8b25-b7300fe93221 68462-112 HUMAN PRESCRIPTION DRUG Aprepitant Aprepitant KIT 20171012 ANDA ANDA207777 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-113_a2e433a6-ad8c-48d9-b52a-398b1168a053 68462-113 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20090227 ANDA ANDA077654 Glenmark Generics Inc., USA CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68462-114_a2e433a6-ad8c-48d9-b52a-398b1168a053 68462-114 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20090227 ANDA ANDA077654 Glenmark Generics Inc., USA CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68462-115_a2e433a6-ad8c-48d9-b52a-398b1168a053 68462-115 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET, FILM COATED ORAL 20090227 ANDA ANDA077654 Glenmark Generics Inc., USA CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68462-123_42e376bd-f2d5-4c65-bffb-0530aed070b2 68462-123 HUMAN OTC DRUG Levonorgestrel Levonorgestrel TABLET ORAL 20160325 ANDA ANDA207044 Glenmark Pharmaceuticals Inc., USA LEVONORGESTREL 1.5 mg/1 N 20181231 68462-126_0108db9f-d923-457c-b2df-c6b358d32b28 68462-126 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Glenmark Pharmaceuticals Inc., USA GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68462-127_0108db9f-d923-457c-b2df-c6b358d32b28 68462-127 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Glenmark Pharmaceuticals Inc., USA GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68462-128_6a2eeaef-5d21-4dd5-bcec-9d493b8261f4 68462-128 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060130 ANDA ANDA077651 Glenmark Pharmaceuticals Inc., USA ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68462-129_6a2eeaef-5d21-4dd5-bcec-9d493b8261f4 68462-129 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060130 ANDA ANDA077651 Glenmark Pharmaceuticals Inc., USA ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68462-130_6a2eeaef-5d21-4dd5-bcec-9d493b8261f4 68462-130 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060130 ANDA ANDA077651 Glenmark Pharmaceuticals Inc., USA ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68462-131_a9b3764d-fd3d-4fcc-8d22-5aa848da1b06 68462-131 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20160805 ANDA ANDA207117 Glenmark Pharmaceuticals Inc., USA TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-132_94c51903-5fe8-4c7b-a746-e08f231dce89 68462-132 HUMAN PRESCRIPTION DRUG Norethindrone Acetate and Ethinyl Estradiol Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20160120 ANDA ANDA206969 Glenmark Pharmaceuticals Inc., USA NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; .02 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68462-137_ee51bca0-bd34-4b7b-aafa-254ce53683fe 68462-137 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Glenmark Pharmaceuticals Inc., USA OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 68462-138_ee51bca0-bd34-4b7b-aafa-254ce53683fe 68462-138 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Glenmark Pharmaceuticals Inc., USA OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 68462-139_ee51bca0-bd34-4b7b-aafa-254ce53683fe 68462-139 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Glenmark Pharmaceuticals Inc., USA OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 68462-140_cb5642d1-1876-4701-b00e-c41b2eab9417 68462-140 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060719 ANDA ANDA077932 Glenmark Pharmaceuticals Inc., USA MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-141_cb5642d1-1876-4701-b00e-c41b2eab9417 68462-141 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060719 ANDA ANDA077932 Glenmark Pharmaceuticals Inc., USA MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-153_3e2ca87d-2ea5-462f-b992-0f45b457a43c 68462-153 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Glenmark Pharmaceuticals Inc., USA TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68462-157_c76453ea-1300-4dd1-ba98-0bf17ce8a30d 68462-157 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Glenmark Pharmaceuticals Inc., USA ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68462-158_c76453ea-1300-4dd1-ba98-0bf17ce8a30d 68462-158 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070627 ANDA ANDA078152 Glenmark Pharmaceuticals Inc., USA ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68462-159_5bfab3d1-d0f1-4cd0-a9e0-bad5d53da82c 68462-159 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20080523 ANDA ANDA078170 Glenmark Pharmaceuticals Inc., USA METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68462-160_5bfab3d1-d0f1-4cd0-a9e0-bad5d53da82c 68462-160 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20080523 ANDA ANDA078170 Glenmark Pharmaceuticals Inc., USA METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68462-161_5bfab3d1-d0f1-4cd0-a9e0-bad5d53da82c 68462-161 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20080523 ANDA ANDA078170 Glenmark Pharmaceuticals Inc., USA METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68462-162_ad38071e-33cd-432e-8e02-4b865013447e 68462-162 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Glenmark Pharmaceuticals Inc., USA CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68462-163_ad38071e-33cd-432e-8e02-4b865013447e 68462-163 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Glenmark Pharmaceuticals Inc., USA CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68462-164_ad38071e-33cd-432e-8e02-4b865013447e 68462-164 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Glenmark Pharmaceuticals Inc., USA CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68462-165_ad38071e-33cd-432e-8e02-4b865013447e 68462-165 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078251 Glenmark Pharmaceuticals Inc., USA CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68462-178_02985e0b-4fa8-4175-a4c0-79fd499e4358 68462-178 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070801 ANDA ANDA078314 Glenmark Pharmaceuticals Inc., USA NAPROXEN SODIUM 275 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-179_02985e0b-4fa8-4175-a4c0-79fd499e4358 68462-179 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070801 ANDA ANDA078314 Glenmark Pharmaceuticals Inc., USA NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-180_f4554b2a-c674-4f6c-bed7-d24d19fb498c 68462-180 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20110608 ANDA ANDA090480 Glenmark Pharmaceuticals Inc., USA MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 68462-181_0521bbd5-1dbd-477e-a6a3-2797b938fa9a 68462-181 HUMAN PRESCRIPTION DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20100804 ANDA ANDA090219 Glenmark Pharmaceuticals Inc., USA CLOTRIMAZOLE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 68462-188_02985e0b-4fa8-4175-a4c0-79fd499e4358 68462-188 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Glenmark Pharmaceuticals Inc., USA NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-189_02985e0b-4fa8-4175-a4c0-79fd499e4358 68462-189 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Glenmark Pharmaceuticals Inc., USA NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-190_02985e0b-4fa8-4175-a4c0-79fd499e4358 68462-190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Glenmark Pharmaceuticals Inc., USA NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-192_cd7653ad-ab49-47c4-aced-938dc4bf7bb1 68462-192 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate CREAM TOPICAL 20080528 ANDA ANDA078541 Glenmark Pharmaceuticals Inc., USA MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-195_0ca9b70d-5134-4af3-99f9-d537fa667000 68462-195 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Glenmark Pharmaceuticals Inc., USA PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68462-196_0ca9b70d-5134-4af3-99f9-d537fa667000 68462-196 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Glenmark Pharmaceuticals Inc., USA PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68462-197_0ca9b70d-5134-4af3-99f9-d537fa667000 68462-197 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Glenmark Pharmaceuticals Inc., USA PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68462-198_0ca9b70d-5134-4af3-99f9-d537fa667000 68462-198 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20071228 ANDA ANDA077987 Glenmark Pharmaceuticals Inc., USA PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68462-199_4bd6558d-fd84-4eec-ad3d-249c8baf65c6 68462-199 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20140707 ANDA ANDA090032 Glenmark Pharmaceuticals Inc., USA TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68462-200_4bd6558d-fd84-4eec-ad3d-249c8baf65c6 68462-200 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20140707 ANDA ANDA090032 Glenmark Pharmaceuticals Inc., USA TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68462-201_4bd6558d-fd84-4eec-ad3d-249c8baf65c6 68462-201 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20140707 ANDA ANDA090032 Glenmark Pharmaceuticals Inc., USA TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68462-204_a1ebd5cf-db90-4b59-a454-ab4a996cec0d 68462-204 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride CAPSULE ORAL 20101215 NDA AUTHORIZED GENERIC NDA200534 Glenmark Pharmaceuticals, Inc OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68462-205_cc336802-c12f-4880-950f-e306340578d5 68462-205 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100318 ANDA ANDA090718 Glenmark Pharmaceuticals Inc., USA MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 15; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68462-206_cc336802-c12f-4880-950f-e306340578d5 68462-206 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100318 ANDA ANDA090718 Glenmark Pharmaceuticals Inc., USA MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 15; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68462-207_cc336802-c12f-4880-950f-e306340578d5 68462-207 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride and Hydrochlorothiazide Moexipril Hydrochloride and Hydrochlorothiazide TABLET, FILM COATED ORAL 20100318 ANDA ANDA090718 Glenmark Pharmaceuticals Inc., USA MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 7.5; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68462-208_48c27a72-1dc6-44a3-8676-c9cd3fa7048b 68462-208 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET, FILM COATED ORAL 20101231 ANDA ANDA090416 Glenmark Pharmaceuticals Inc., USA MOEXIPRIL HYDROCHLORIDE 15 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68462-209_48c27a72-1dc6-44a3-8676-c9cd3fa7048b 68462-209 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET, FILM COATED ORAL 20101231 ANDA ANDA090416 Glenmark Pharmaceuticals Inc., USA MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68462-220_b29256f4-4249-4c14-ba0a-9ae9e6907c9e 68462-220 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090203 ANDA ANDA079139 Glenmark Pharmaceuticals Inc., USA LITHIUM CARBONATE 150 mg/1 Mood Stabilizer [EPC] N 20181231 68462-221_b29256f4-4249-4c14-ba0a-9ae9e6907c9e 68462-221 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090203 ANDA ANDA079139 Glenmark Pharmaceuticals Inc., USA LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 68462-222_b29256f4-4249-4c14-ba0a-9ae9e6907c9e 68462-222 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20090203 ANDA ANDA079139 Glenmark Pharmaceuticals Inc., USA LITHIUM CARBONATE 600 mg/1 Mood Stabilizer [EPC] N 20181231 68462-223_240064d4-c967-4d57-9464-f651ec707360 68462-223 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101227 ANDA ANDA091544 Glenmark Pharmaceuticals Inc., USA LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 68462-224_444c09e2-9345-4544-ad03-8dd7fb3b6c70 68462-224 HUMAN PRESCRIPTION DRUG Lithium Carbonate ER Lithium Carbonate TABLET ORAL 20110214 ANDA ANDA091616 Glenmark Pharmaceuticals Inc., USA LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] N 20181231 68462-225_c39bd11d-bdb7-41a0-8158-25e97019c11f 68462-225 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone furoate OINTMENT TOPICAL 20080528 ANDA ANDA078571 Glenmark Pharmaceuticals Inc., USA MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-226_ddbb1b63-433a-4640-88d6-0548fdb8a56e 68462-226 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20150626 ANDA ANDA078560 Glenmark Pharmaceuticals Inc., USA EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 68462-228_95b759a5-d3b6-4c3b-b69b-1958523056ab 68462-228 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090219 ANDA ANDA079099 Glenmark Pharmaceuticals Inc., USA LAMOTRIGINE 5 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68462-229_95b759a5-d3b6-4c3b-b69b-1958523056ab 68462-229 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20090219 ANDA ANDA079099 Glenmark Pharmaceuticals Inc., USA LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68462-230_70df2b18-ff49-4836-849c-0d36b76878c6 68462-230 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 20180801 ANDA ANDA091672 Glenmark Pharmaceuticals Inc., USA OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68462-231_70df2b18-ff49-4836-849c-0d36b76878c6 68462-231 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 20180801 ANDA ANDA091672 Glenmark Pharmaceuticals Inc., USA OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68462-232_70df2b18-ff49-4836-849c-0d36b76878c6 68462-232 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 20180801 ANDA ANDA091672 Glenmark Pharmaceuticals Inc., USA OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 68462-233_e9a003c3-4d40-460d-a8c6-eedbe3c06f45 68462-233 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA090365 Glenmark Pharmaceuticals Inc., USA FELODIPINE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68462-234_e9a003c3-4d40-460d-a8c6-eedbe3c06f45 68462-234 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA090365 Glenmark Pharmaceuticals Inc., USA FELODIPINE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68462-235_e9a003c3-4d40-460d-a8c6-eedbe3c06f45 68462-235 HUMAN PRESCRIPTION DRUG Felodipine Felodipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101220 ANDA ANDA090365 Glenmark Pharmaceuticals Inc., USA FELODIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68462-243_7c5834f5-1006-4617-97a5-9920dec7b847 68462-243 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120504 ANDA ANDA090169 Glenmark Pharmaceuticals Inc., USA LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68462-244_7c5834f5-1006-4617-97a5-9920dec7b847 68462-244 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120504 ANDA ANDA090169 Glenmark Pharmaceuticals Inc., USA LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68462-245_7c5834f5-1006-4617-97a5-9920dec7b847 68462-245 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120504 ANDA ANDA090169 Glenmark Pharmaceuticals Inc., USA LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68462-246_7c5834f5-1006-4617-97a5-9920dec7b847 68462-246 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20120504 ANDA ANDA090169 Glenmark Pharmaceuticals Inc., USA LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68462-248_342c8499-74fe-4f3b-97c0-f144244b2f8e 68462-248 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Glenmark Generics Inc., USA RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68462-249_342c8499-74fe-4f3b-97c0-f144244b2f8e 68462-249 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Glenmark Generics Inc., USA RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68462-252_12741be9-593f-460b-8e53-1493df143dca 68462-252 HUMAN PRESCRIPTION DRUG Desonide Desonide CREAM TOPICAL 20170724 ANDA ANDA209729 Glenmark Pharmaceuticals Inc., USA DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-253_1112500c-5f22-488f-8ead-f7c5c5e5b9af 68462-253 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Pharmaceuticals Inc., USA ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-254_1112500c-5f22-488f-8ead-f7c5c5e5b9af 68462-254 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Pharmaceuticals Inc., USA ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-255_1112500c-5f22-488f-8ead-f7c5c5e5b9af 68462-255 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Pharmaceuticals Inc., USA ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-256_1112500c-5f22-488f-8ead-f7c5c5e5b9af 68462-256 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Pharmaceuticals Inc., USA ROPINIROLE HYDROCHLORIDE 2 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-257_1112500c-5f22-488f-8ead-f7c5c5e5b9af 68462-257 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Pharmaceuticals Inc., USA ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-258_1112500c-5f22-488f-8ead-f7c5c5e5b9af 68462-258 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Pharmaceuticals Inc., USA ROPINIROLE HYDROCHLORIDE 4 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-259_1112500c-5f22-488f-8ead-f7c5c5e5b9af 68462-259 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Glenmark Pharmaceuticals Inc., USA ROPINIROLE HYDROCHLORIDE 5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-260_c9d7867f-5f1c-4c58-916a-fda14719a2cf 68462-260 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090917 ANDA ANDA078906 Glenmark Pharmaceuticals Inc., USA VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68462-261_a8c14943-e4e5-41b1-9551-1b4c62b39051 68462-261 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079172 Glenmark Pharmaceutials Inc., USA ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68462-262_a8c14943-e4e5-41b1-9551-1b4c62b39051 68462-262 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079172 Glenmark Pharmaceutials Inc., USA ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68462-263_a8c14943-e4e5-41b1-9551-1b4c62b39051 68462-263 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079172 Glenmark Pharmaceutials Inc., USA ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68462-264_a8c14943-e4e5-41b1-9551-1b4c62b39051 68462-264 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079172 Glenmark Pharmaceutials Inc., USA ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68462-265_0ab8d905-e890-4e91-a730-3e5d12f5c23f 68462-265 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079019 Glenmark Pharmaceuticals Inc., USA ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68462-266_0ab8d905-e890-4e91-a730-3e5d12f5c23f 68462-266 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079019 Glenmark Pharmaceuticals Inc., USA ATOMOXETINE HYDROCHLORIDE 18 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68462-267_0ab8d905-e890-4e91-a730-3e5d12f5c23f 68462-267 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079019 Glenmark Pharmaceuticals Inc., USA ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68462-268_0ab8d905-e890-4e91-a730-3e5d12f5c23f 68462-268 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079019 Glenmark Pharmaceuticals Inc., USA ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68462-269_0ab8d905-e890-4e91-a730-3e5d12f5c23f 68462-269 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079019 Glenmark Pharmaceuticals Inc., USA ATOMOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68462-270_0ab8d905-e890-4e91-a730-3e5d12f5c23f 68462-270 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079019 Glenmark Pharmaceuticals Inc., USA ATOMOXETINE HYDROCHLORIDE 80 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68462-271_0ab8d905-e890-4e91-a730-3e5d12f5c23f 68462-271 HUMAN PRESCRIPTION DRUG atomoxetine atomoxetine CAPSULE ORAL 20170530 ANDA ANDA079019 Glenmark Pharmaceuticals Inc., USA ATOMOXETINE HYDROCHLORIDE 100 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68462-275_f0ae047c-4feb-4de2-876e-3d3e423c0c20 68462-275 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20150528 ANDA ANDA201831 Glenmark Pharmaceuticals Inc.,USA DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 68462-276_f0ae047c-4feb-4de2-876e-3d3e423c0c20 68462-276 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20150528 ANDA ANDA201831 Glenmark Pharmaceuticals Inc.,USA DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 68462-290_0d85201f-8161-476e-8a2b-022158b5b9de 68462-290 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20080923 ANDA ANDA078930 Glenmark Pharmaceuticals Inc., USA BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 68462-291_9a8495cb-a502-4b41-a5b0-5e129e40db67 68462-291 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20151221 ANDA ANDA078987 Glenmark Pharmaceuticals Inc., USA LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 68462-292_c9d7867f-5f1c-4c58-916a-fda14719a2cf 68462-292 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 Glenmark Pharmaceuticals Inc., USA VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68462-293_c9d7867f-5f1c-4c58-916a-fda14719a2cf 68462-293 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 Glenmark Pharmaceuticals Inc., USA VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68462-294_df1a0c56-7e3d-488e-a3df-e3a5937823c9 68462-294 HUMAN PRESCRIPTION DRUG Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150225 ANDA ANDA079135 Glenmark Pharmaceuticals Inc., USA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 1; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68462-295_df1a0c56-7e3d-488e-a3df-e3a5937823c9 68462-295 HUMAN PRESCRIPTION DRUG Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150225 ANDA ANDA079135 Glenmark Pharmaceuticals Inc., USA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 180 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68462-296_df1a0c56-7e3d-488e-a3df-e3a5937823c9 68462-296 HUMAN PRESCRIPTION DRUG Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150225 ANDA ANDA079135 Glenmark Pharmaceuticals Inc., USA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68462-297_57a109a9-734f-4b19-ba06-72f300f52863 68462-297 HUMAN PRESCRIPTION DRUG Ciclopirox Olamine Ciclopirox Olamine CREAM TOPICAL 20091113 ANDA ANDA090273 Glenmark Pharmaceuticals Inc., USA CICLOPIROX OLAMINE 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 68462-298_8dcd24cb-e568-428a-88ac-737d115cc54d 68462-298 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20151106 ANDA ANDA202894 Glenmark Pharmaceuticals Inc. USA CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-299_134818b9-1557-4540-a348-39c982ce2256 68462-299 HUMAN PRESCRIPTION DRUG Alclometasone Dipropionate Alclometasone Dipropionate OINTMENT TOPICAL 20090730 ANDA ANDA079227 Glenmark Pharmaceuticals Inc., USA ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-300_134818b9-1557-4540-a348-39c982ce2256 68462-300 HUMAN PRESCRIPTION DRUG Alclometasone Dipropionate Alclometasone Dipropionate CREAM TOPICAL 20090623 ANDA ANDA079061 Glenmark Pharmaceuticals Inc., USA ALCLOMETASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-302_26c5aff2-41de-4d5a-a169-fa5034219fca 68462-302 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Glenmark Pharmaceuticals Inc., USA INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-303_d6a2cc17-4af4-4446-b870-9281bc6533a6 68462-303 HUMAN PRESCRIPTION DRUG HEATHER Norethindrone TABLET ORAL 20100423 ANDA ANDA090454 Glenmark Pharmaceuticals Inc., USA NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68462-304_7141b6e7-5856-4d37-9b7c-ac34207c3f91 68462-304 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone Acetate TABLET ORAL 20100721 ANDA ANDA091090 Glenmark Pharmaceuticals Inc., USA NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68462-305_336e6f7b-ba28-4b88-9908-ae3d47be8ead 68462-305 HUMAN PRESCRIPTION DRUG Norethindrone Norethindrone TABLET ORAL 20101103 ANDA ANDA091209 Glenmark Pharmaceuticals Inc., USA NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68462-309_c8d07da3-c193-4d40-9edf-d1b45b47fe1c 68462-309 HUMAN PRESCRIPTION DRUG Norgestimate and Ethinyl Estradiol Norgestimate and Ethinyl Estradiol KIT 20120406 ANDA ANDA200538 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-310_dff36b6e-5658-4aee-ad2a-2a2d3d4ca4b7 68462-310 HUMAN PRESCRIPTION DRUG Calcipotriene Calcipotriene OINTMENT TOPICAL 20100324 ANDA ANDA090633 Glenmark Pharmaceuticals Inc., USA CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 68462-314_44a37f35-e533-4b09-bbcf-97ffaff1920b 68462-314 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 20161024 ANDA ANDA208136 Glenmark Pharmaceuticals Inc., USA NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-316_f1eb85b8-6a52-44fc-803d-84599ccc792a 68462-316 HUMAN PRESCRIPTION DRUG BRIELLYN Norethindrone and Ethinyl Estradiol KIT 20110323 ANDA ANDA090538 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-318_ac5575ca-0e0a-4eb1-86f4-0f3ca1cf24e3 68462-318 HUMAN PRESCRIPTION DRUG VIORELE Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol KIT 20120404 ANDA ANDA091346 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-325_b94d1aeb-c908-4566-867e-11a03d70e383 68462-325 HUMAN PRESCRIPTION DRUG indomethacin indomethacin CAPSULE, EXTENDED RELEASE ORAL 20170622 ANDA ANDA203501 Glenmark Pharmaceuticals Inc., USA INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-329_df1a0c56-7e3d-488e-a3df-e3a5937823c9 68462-329 HUMAN PRESCRIPTION DRUG Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150225 ANDA ANDA079135 Glenmark Pharmaceuticals Inc., USA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4; 240 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68462-330_671593fb-b145-49c5-9bf7-9621eb90a155 68462-330 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20101008 ANDA ANDA090781 Glenmark Pharmaceuticals Inc., USA PRAMIPEXOLE DIHYDROCHLORIDE .125 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-331_671593fb-b145-49c5-9bf7-9621eb90a155 68462-331 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20101008 ANDA ANDA090781 Glenmark Pharmaceuticals Inc., USA PRAMIPEXOLE DIHYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-332_671593fb-b145-49c5-9bf7-9621eb90a155 68462-332 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20101008 ANDA ANDA090781 Glenmark Pharmaceuticals Inc., USA PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-333_671593fb-b145-49c5-9bf7-9621eb90a155 68462-333 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20101008 ANDA ANDA090781 Glenmark Pharmaceuticals Inc., USA PRAMIPEXOLE DIHYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-334_671593fb-b145-49c5-9bf7-9621eb90a155 68462-334 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20101008 ANDA ANDA090781 Glenmark Pharmaceuticals Inc., USA PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-339_e45624a4-58bf-47c2-9a22-de072ae7c662 68462-339 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110114 ANDA ANDA090828 Glenmark Generics Inc. USA SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68462-340_e45624a4-58bf-47c2-9a22-de072ae7c662 68462-340 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110114 ANDA ANDA090828 Glenmark Generics Inc. USA SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68462-341_a1e6559c-42b4-4a69-980b-1e6de5127c8e 68462-341 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Glenmark Pharmaceuticals Inc., USA HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68462-342_a1e6559c-42b4-4a69-980b-1e6de5127c8e 68462-342 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Glenmark Pharmaceuticals Inc., USA HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68462-343_a1e6559c-42b4-4a69-980b-1e6de5127c8e 68462-343 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Glenmark Pharmaceuticals Inc., USA HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68462-344_a1e6559c-42b4-4a69-980b-1e6de5127c8e 68462-344 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20090601 ANDA ANDA090527 Glenmark Pharmaceuticals Inc., USA HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68462-346_3e8010d8-7146-43db-8746-3fe57881beb1 68462-346 HUMAN PRESCRIPTION DRUG LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride TABLET ORAL 20110225 ANDA ANDA090385 Glenmark Pharmaceuticals Inc., USA LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 68462-347_2f939fda-d251-49ca-bdf1-5f96523533df 68462-347 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20101220 NDA AUTHORIZED GENERIC NDA200535 Glenmark Pharmaceuticals, Inc OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 68462-352_4f2a6947-2cf6-42ce-82b3-59d481ef33fb 68462-352 HUMAN PRESCRIPTION DRUG hydroxyzine hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20150201 ANDA ANDA040812 Glenmark Pharmaceuticals Inc., USA HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68462-353_4f2a6947-2cf6-42ce-82b3-59d481ef33fb 68462-353 HUMAN PRESCRIPTION DRUG hydroxyzine hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20150201 ANDA ANDA040812 Glenmark Pharmaceuticals Inc., USA HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68462-354_4f2a6947-2cf6-42ce-82b3-59d481ef33fb 68462-354 HUMAN PRESCRIPTION DRUG hydroxyzine hydrochloride hydroxyzine hydrochloride TABLET, FILM COATED ORAL 20150201 ANDA ANDA040812 Glenmark Pharmaceuticals Inc., USA HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68462-355_dab3ae60-0135-43b3-a1d0-8752720af82a 68462-355 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM diclofenac sodium GEL TOPICAL 20160913 ANDA ANDA208301 Glenmark Pharmaceuticals Inc., USA DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-356_578cbc91-7cec-412b-9c8c-eed523830b8d 68462-356 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20100713 ANDA ANDA090355 Glenmark Pharmaceuticals Inc., USA THEOPHYLLINE ANHYDROUS 600 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68462-357_5b054142-7372-4641-be27-dca630a97ad9 68462-357 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride CAPSULE, EXTENDED RELEASE ORAL 20160120 ANDA ANDA202868 Glenmark Pharmaceuticals Inc., USA POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68462-358_632ca18e-0ce3-4696-bc8b-a06ab8b8040f 68462-358 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Glenmark Pharmaceuticals Inc., USA NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-359_632ca18e-0ce3-4696-bc8b-a06ab8b8040f 68462-359 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Glenmark Pharmaceuticals Inc., USA NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-376_d62f63c3-7578-4ece-9377-dae4874f50d4 68462-376 HUMAN PRESCRIPTION DRUG norethindrone acetate and ethinyl estradiol and ferrous fumarate norethindrone acetate and ethinyl estradiol and ferrous fumarate KIT 20171226 ANDA ANDA210369 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-380_578cbc91-7cec-412b-9c8c-eed523830b8d 68462-380 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20100713 ANDA ANDA090355 Glenmark Pharmaceuticals Inc., USA THEOPHYLLINE ANHYDROUS 400 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68462-381_f7d0144c-723e-4749-a78c-c7dd2aa41549 68462-381 HUMAN PRESCRIPTION DRUG riluzole riluzole TABLET, FILM COATED ORAL 20130618 ANDA ANDA091394 Glenmark Pharmaceuticals Inc., USA RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] N 20181231 68462-382_01ea7455-4e93-47cb-91a1-ddce2bcd5edd 68462-382 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091166 Glenmark Pharmaceuticals Inc., USA ESZOPICLONE 1 mg/1 CIV N 20181231 68462-383_01ea7455-4e93-47cb-91a1-ddce2bcd5edd 68462-383 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091166 Glenmark Pharmaceuticals Inc., USA ESZOPICLONE 2 mg/1 CIV N 20181231 68462-384_01ea7455-4e93-47cb-91a1-ddce2bcd5edd 68462-384 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091166 Glenmark Pharmaceuticals Inc., USA ESZOPICLONE 3 mg/1 CIV N 20181231 68462-385_fd5179f5-5926-457e-b2db-5ce60a4153e3 68462-385 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate LOTION TOPICAL 20100809 ANDA ANDA078541 Glenmark Pharmaceuticals Inc., USA MOMETASONE FUROATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-388_9517cfb6-4022-4e74-a41e-eb73c6480dc6 68462-388 HUMAN PRESCRIPTION DRUG MARLISSA Levonorgestrel and Ethinyl Estradiol KIT 20120229 ANDA ANDA091452 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-392_f0d0622b-cef1-4983-95df-09219e08530b 68462-392 HUMAN PRESCRIPTION DRUG montelukast sodium montelukast sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA090926 Glenmark Pharmaceuticals Inc., USA MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68462-393_c05521f8-95d2-44b8-8433-eba539c0f84c 68462-393 HUMAN PRESCRIPTION DRUG raloxifene hydrochloride raloxifene hydrochloride TABLET, FILM COATED ORAL 20160322 ANDA ANDA204491 Glenmark Pharmaceuticals Inc., USA RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 68462-394_6369f938-c6b8-46c9-b1d5-4765fa73b9a3 68462-394 HUMAN PRESCRIPTION DRUG ALYACEN 1/35 norethindrone and ethinyl estradiol KIT 20120119 ANDA ANDA091634 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-395_02ae51a5-f6ff-4d80-bfbb-6a034457d600 68462-395 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Glenmark Pharmaceuticals Inc., USA OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68462-396_02ae51a5-f6ff-4d80-bfbb-6a034457d600 68462-396 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Glenmark Pharmaceuticals Inc., USA OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68462-397_02ae51a5-f6ff-4d80-bfbb-6a034457d600 68462-397 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Glenmark Pharmaceuticals Inc., USA OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68462-402_06cb2e41-f74d-48c9-9401-0ecf97b85a7d 68462-402 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Pediatric Atovaquone and Proguanil Hydrochloride Pediatric TABLET, FILM COATED ORAL 20150408 ANDA ANDA091211 Glenmark Pharmaceuticals Inc.,USA ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5; 25 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 68462-403_037cef3f-60b1-4969-9057-36e3a0a38e7f 68462-403 HUMAN PRESCRIPTION DRUG Adapalene Adapalene GEL TOPICAL 20100701 ANDA ANDA091314 Glenmark Pharmaceuticals Inc., USA ADAPALENE 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 68462-404_06cb2e41-f74d-48c9-9401-0ecf97b85a7d 68462-404 HUMAN PRESCRIPTION DRUG Atovaquone and Proguanil Hydrochloride Atovaquone and Proguanil Hydrochloride TABLET, FILM COATED ORAL 20110818 ANDA ANDA091211 Glenmark Pharmaceuticals Inc.,USA ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250; 100 mg/1; mg/1 Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 68462-406_26c5aff2-41de-4d5a-a169-fa5034219fca 68462-406 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Glenmark Pharmaceuticals Inc., USA INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68462-408_c6890ed8-ef11-4889-aa53-a4bc9da16653 68462-408 HUMAN PRESCRIPTION DRUG propafenone hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170908 ANDA ANDA205268 Glenmark Pharmaceuticals Inc., USA PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] N 20181231 68462-409_c6890ed8-ef11-4889-aa53-a4bc9da16653 68462-409 HUMAN PRESCRIPTION DRUG propafenone hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170908 ANDA ANDA205268 Glenmark Pharmaceuticals Inc., USA PROPAFENONE HYDROCHLORIDE 325 mg/1 Antiarrhythmic [EPC] N 20181231 68462-410_c6890ed8-ef11-4889-aa53-a4bc9da16653 68462-410 HUMAN PRESCRIPTION DRUG propafenone hydrochloride propafenone hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170908 ANDA ANDA205268 Glenmark Pharmaceuticals Inc., USA PROPAFENONE HYDROCHLORIDE 425 mg/1 Antiarrhythmic [EPC] N 20181231 68462-418_eaa15be7-11ea-49bc-ac07-739075453be6 68462-418 HUMAN PRESCRIPTION DRUG lidocaine lidocaine OINTMENT TOPICAL 20160909 ANDA ANDA206498 Glenmark Pharmaceuticals Inc., USA LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 68462-419_e73e38a4-1cad-4c5a-b083-c12c876e621c 68462-419 HUMAN PRESCRIPTION DRUG HAILEY Fe 1/20 norethindrone acetate and ethinyl estradiol and ferrous fumarate KIT 20171121 ANDA ANDA206597 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-425_471123bb-f0b6-486b-b5f8-b0d3e06fe56c 68462-425 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20110715 ANDA ANDA090618 Glenmark Generics Inc.,USA NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68462-426_471123bb-f0b6-486b-b5f8-b0d3e06fe56c 68462-426 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20110715 ANDA ANDA090618 Glenmark Generics Inc.,USA NIZATIDINE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68462-427_fed601b8-92df-49b8-b9a7-ea3064402f43 68462-427 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate LOTION TOPICAL 20111013 ANDA ANDA090759 Glenmark Pharmaceuticals Inc., USA FLUTICASONE PROPIONATE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-435_94639188-9f3b-47ad-b9a6-eb4de631ac6b 68462-435 HUMAN PRESCRIPTION DRUG Acamprosate Calcium Acamprosate Calcium TABLET, DELAYED RELEASE ORAL 20130716 ANDA ANDA202229 Glenmark Pharmaceuticals Inc., USA ACAMPROSATE CALCIUM 333 mg/1 N 20181231 68462-436_8e0adf3d-7569-4909-bab1-5fed9578ad77 68462-436 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170525 ANDA ANDA203281 Glenmark Pharmaceuticals Inc., USA OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68462-437_8e0adf3d-7569-4909-bab1-5fed9578ad77 68462-437 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170525 ANDA ANDA203281 Glenmark Pharmaceuticals Inc., USA OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68462-438_8e0adf3d-7569-4909-bab1-5fed9578ad77 68462-438 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170525 ANDA ANDA203281 Glenmark Pharmaceuticals Inc., USA OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68462-455_f4188436-4d86-48c2-89a9-7c73862bb8fe 68462-455 HUMAN PRESCRIPTION DRUG ciclopirox ciclopirox GEL TOPICAL 20120229 ANDA ANDA091595 Glenmark Pharmaceuticals Inc., USA CICLOPIROX 7.7 mg/g Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 68462-461_5be9c908-2758-4015-842c-99443b933d34 68462-461 HUMAN PRESCRIPTION DRUG Trospium Chloride Trospium Chloride TABLET, FILM COATED ORAL 20100813 ANDA ANDA091575 Glenmark Pharmaceuticals Inc., USA TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68462-464_bf8a1422-04b3-4209-ad6d-714be2ea53d4 68462-464 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate Hydrocortisone Butyrate CREAM TOPICAL 20131205 ANDA ANDA202145 Glenmark Pharmaceuticals Inc., USA HYDROCORTISONE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-465_987a8e63-8227-4e15-b7b8-a0a16a982a26 68462-465 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET ORAL 20121231 ANDA ANDA201967 Glenmark Pharmaceuticals Inc., USA RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68462-466_987a8e63-8227-4e15-b7b8-a0a16a982a26 68462-466 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET ORAL 20121231 ANDA ANDA201967 Glenmark Pharmaceuticals Inc., USA RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68462-467_e297c70d-7bd5-424c-83f9-67e063b09bb4 68462-467 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA201914 Glenmark Pharmaceuticals Inc., USA RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68462-468_e297c70d-7bd5-424c-83f9-67e063b09bb4 68462-468 HUMAN PRESCRIPTION DRUG rizatriptan benzoate rizatriptan benzoate TABLET, ORALLY DISINTEGRATING ORAL 20130701 ANDA ANDA201914 Glenmark Pharmaceuticals Inc., USA RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68462-471_63bedd99-0596-49d2-ad04-d1d8ac15cc42 68462-471 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20160726 ANDA ANDA203562 Glenmark Pharmaceuticals Inc., USA POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68462-472_63bedd99-0596-49d2-ad04-d1d8ac15cc42 68462-472 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20160726 ANDA ANDA203562 Glenmark Pharmaceuticals Inc., USA POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68462-473_7a3c38cc-c55e-4ffe-9aff-9a6480431448 68462-473 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET ORAL 20110712 ANDA ANDA090801 Glenmark Pharmaceuticals Inc., USA URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 68462-474_7a3c38cc-c55e-4ffe-9aff-9a6480431448 68462-474 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET ORAL 20110712 ANDA ANDA090801 Glenmark Pharmaceuticals Inc., USA URSODIOL 500 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 68462-497_e9e764d6-c9be-4f56-85fe-130414fb0515 68462-497 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20130514 ANDA ANDA201779 Glenmark Pharmaceuticals Inc., USA ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68462-498_e9e764d6-c9be-4f56-85fe-130414fb0515 68462-498 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20130514 ANDA ANDA201779 Glenmark Pharmaceuticals Inc., USA ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68462-499_9ba10cdc-c541-43b3-9afb-8480723c8b03 68462-499 HUMAN PRESCRIPTION DRUG zolmiptriptan zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130514 ANDA ANDA202560 Glenmark Pharmaceuticals Inc., USA ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68462-500_9ba10cdc-c541-43b3-9afb-8480723c8b03 68462-500 HUMAN PRESCRIPTION DRUG zolmiptriptan zolmitriptan TABLET, ORALLY DISINTEGRATING ORAL 20130514 ANDA ANDA202560 Glenmark Pharmaceuticals Inc., USA ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68462-501_7ec750f6-26ea-46bc-aa7b-174fd25253a2 68462-501 HUMAN PRESCRIPTION DRUG calcipotriene calcipotriene CREAM TOPICAL 20150610 ANDA ANDA205772 Glenmark Pharmaceuticals Inc.,USA CALCIPOTRIENE 50 ug/g Vitamin D [Chemical/Ingredient],Vitamin D Analog [EPC] N 20181231 68462-502_268fa5a8-5373-2766-e054-00144ff8d46c 68462-502 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 19990801 ANDA ANDA075252 Glenmark Pharmaceuticals, Inc AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 68462-502_5f4a84d0-4816-0ba5-e053-2a91aa0a6e9d 68462-502 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 19990801 ANDA ANDA075252 Glenmark Pharmaceuticals, Inc AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 68462-505_bae9a0e4-2777-44af-8157-9e894061c964 68462-505 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140714 ANDA ANDA091282 Glenmark Pharmaceuticals Inc., USA FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-513_89a5439d-a61b-44f5-8ab8-c552eb3fddd9 68462-513 HUMAN PRESCRIPTION DRUG desonide desonide LOTION TOPICAL 20170926 ANDA ANDA209494 Glenmark Pharmaceuticals Inc., USA DESONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-528_616c2100-8f29-4903-977d-77827f3241d2 68462-528 HUMAN PRESCRIPTION DRUG Desonide Desonide OINTMENT TOPICAL 20170915 ANDA ANDA209996 Glenmark Pharmaceuticals Inc., USA DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-530_a4a79d9f-c84e-4583-ab27-ad2327979e03 68462-530 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20170320 ANDA ANDA208933 Glenmark Pharmaceuticals Inc., USA CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 68462-531_24bb9fcb-34da-4de0-bdb2-dd558eee6d48 68462-531 HUMAN PRESCRIPTION DRUG Desoximetasone Desoximetasone OINTMENT TOPICAL 20130920 ANDA ANDA202838 Glenmark Pharmaceuticals Inc., USA DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-536_f310518e-0cee-491d-b5ff-c1eb63ea7c1a 68462-536 HUMAN PRESCRIPTION DRUG Imiquimod Imiquimod CREAM TOPICAL 20120306 ANDA ANDA201994 Glenmark Pharmaceuticals Inc., USA IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] N 20181231 68462-554_687c6dae-abd4-420c-a457-7150bc6a081b 68462-554 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA090228 Glenmark Pharmaceuticals Inc., USA FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68462-555_687c6dae-abd4-420c-a457-7150bc6a081b 68462-555 HUMAN PRESCRIPTION DRUG Fosinopril Sodium and Hydrochlorothiazide Fosinopril Sodium and Hydrochlorothiazide TABLET ORAL 20090709 ANDA ANDA090228 Glenmark Pharmaceuticals Inc., USA FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68462-556_6369f938-c6b8-46c9-b1d5-4765fa73b9a3 68462-556 HUMAN PRESCRIPTION DRUG ALYACEN 7/7/7 norethindrone and ethinyl estradiol KIT 20120119 ANDA ANDA091636 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-564_87a908f7-52fe-4e2c-a5cb-c12e00e733ab 68462-564 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin CREAM TOPICAL 20130124 ANDA ANDA201587 Glenmark Pharmaceuticals Inc., USA MUPIROCIN CALCIUM 2 g/100g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 68462-565_c8d07da3-c193-4d40-9edf-d1b45b47fe1c 68462-565 HUMAN PRESCRIPTION DRUG Norgestimate and Ethinyl Estradiol Norgestimate and Ethinyl Estradiol KIT 20110617 ANDA ANDA200494 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-566_0151a4f5-40ec-4054-8487-8327b23841cb 68462-566 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170705 ANDA ANDA207807 Glenmark Pharmaceuticals Inc., USA AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68462-567_0151a4f5-40ec-4054-8487-8327b23841cb 68462-567 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170705 ANDA ANDA207807 Glenmark Pharmaceuticals Inc., USA AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68462-568_0151a4f5-40ec-4054-8487-8327b23841cb 68462-568 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170705 ANDA ANDA207807 Glenmark Pharmaceuticals Inc., USA AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68462-569_0151a4f5-40ec-4054-8487-8327b23841cb 68462-569 HUMAN PRESCRIPTION DRUG Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170705 ANDA ANDA207807 Glenmark Pharmaceuticals Inc., USA AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68462-572_8e2cd0de-c986-4db8-98f1-667222e45670 68462-572 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20150904 ANDA ANDA203503 Glenmark Pharmaceuticals Inc., USA VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68462-573_8e2cd0de-c986-4db8-98f1-667222e45670 68462-573 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20150904 ANDA ANDA203503 Glenmark Pharmaceuticals Inc., USA VORICONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68462-580_24a64fec-4805-4c6c-a346-32ee971ef42d 68462-580 HUMAN PRESCRIPTION DRUG fenofibrate fenofibrate CAPSULE ORAL 20170407 ANDA ANDA205566 Glenmark Pharmaceuticals Inc., USA FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68462-581_24a64fec-4805-4c6c-a346-32ee971ef42d 68462-581 HUMAN PRESCRIPTION DRUG fenofibrate fenofibrate CAPSULE ORAL 20170407 ANDA ANDA205566 Glenmark Pharmaceuticals Inc., USA FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68462-582_24a64fec-4805-4c6c-a346-32ee971ef42d 68462-582 HUMAN PRESCRIPTION DRUG fenofibrate fenofibrate CAPSULE ORAL 20170407 ANDA ANDA205566 Glenmark Pharmaceuticals Inc., USA FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68462-583_9a03e97e-ec9e-4e14-8b25-b7300fe93221 68462-583 HUMAN PRESCRIPTION DRUG Aprepitant Aprepitant CAPSULE ORAL 20171012 ANDA ANDA207777 Glenmark Pharmaceuticals Inc., USA APREPITANT 40 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 68462-584_9a03e97e-ec9e-4e14-8b25-b7300fe93221 68462-584 HUMAN PRESCRIPTION DRUG Aprepitant Aprepitant CAPSULE ORAL 20171012 ANDA ANDA207777 Glenmark Pharmaceuticals Inc., USA APREPITANT 80 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 68462-585_9a03e97e-ec9e-4e14-8b25-b7300fe93221 68462-585 HUMAN PRESCRIPTION DRUG Aprepitant Aprepitant CAPSULE ORAL 20171012 ANDA ANDA207777 Glenmark Pharmaceuticals Inc., USA APREPITANT 125 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA] N 20181231 68462-627_671593fb-b145-49c5-9bf7-9621eb90a155 68462-627 HUMAN PRESCRIPTION DRUG Pramipexole dihydrochloride Pramipexole dihydrochloride TABLET ORAL 20160131 ANDA ANDA090781 Glenmark Pharmaceuticals Inc., USA PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 68462-637_33a3a210-87b7-4064-9e3c-70c50484478a 68462-637 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol Levonorgestrel and Ethinyl Estradiol TABLET ORAL 20150409 ANDA ANDA202791 Glenmark Pharmaceuticals Inc., USA LEVONORGESTREL; ETHINYL ESTRADIOL 90; 20 ug/1; ug/1 Inhibit Ovum Fertilization [PE],Progesterone Congeners [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Progestin-containing Intrauterine Device [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68462-638_1e5029a7-428f-46c8-8473-63585d8278c2 68462-638 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET SUBLINGUAL 20170819 ANDA ANDA206391 Glenmark Pharmaceuticals Inc., USA NITROGLYCERIN .3 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68462-639_1e5029a7-428f-46c8-8473-63585d8278c2 68462-639 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET SUBLINGUAL 20170919 ANDA ANDA206391 Glenmark Pharmaceuticals Inc., USA NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68462-640_1e5029a7-428f-46c8-8473-63585d8278c2 68462-640 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET SUBLINGUAL 20170919 ANDA ANDA206391 Glenmark Pharmaceuticals Inc., USA NITROGLYCERIN .6 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68462-646_77abaec4-576f-46ce-91e0-54ed383340bb 68462-646 HUMAN PRESCRIPTION DRUG Ashlyna Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol KIT 20150223 ANDA ANDA203163 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-656_e7b6e7b5-d971-4349-a6b9-4b8fca54b27d 68462-656 HUMAN PRESCRIPTION DRUG Norethindrone Acetate and Ethinyl Estradiol Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20150402 ANDA ANDA203038 Glenmark Pharmaceuticals Inc., USA NORETHINDRONE ACETATE; ETHINYL ESTRADIOL .5; 2.5 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20191231 68462-657_e7b6e7b5-d971-4349-a6b9-4b8fca54b27d 68462-657 HUMAN PRESCRIPTION DRUG Norethindrone Acetate and Ethinyl Estradiol Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20150402 ANDA ANDA203038 Glenmark Pharmaceuticals Inc., USA NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; 5 mg/1; ug/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20191231 68462-672_bda6e8ee-cf7a-45c7-9074-a3b7a8661c61 68462-672 HUMAN PRESCRIPTION DRUG levonorgestrel and ethinyl estradiol levonorgestrel and ethinyl estradiol KIT 20150612 ANDA ANDA203164 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-694_03a58215-dba7-4f63-8b98-d74d054a574a 68462-694 HUMAN PRESCRIPTION DRUG frovatriptan succinate frovatriptan succinate TABLET, FILM COATED ORAL 20160311 ANDA ANDA204730 Glenmark Pharmaceuticals Inc., USA FROVATRIPTAN SUCCINATE 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68462-719_839cc0cb-2339-4687-ad3f-c002a08d0516 68462-719 HUMAN PRESCRIPTION DRUG norgestimate and ethinyl estradiol norgestimate and ethinyl estradiol KIT 20160223 ANDA ANDA204057 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-720_407abb39-8f1c-4109-a907-e1ec003e1eb1 68462-720 HUMAN PRESCRIPTION DRUG drospirenone and ethinyl estradiol drospirenone and ethinyl estradiol KIT 20150817 ANDA ANDA204296 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-731_ab399c1c-5613-4e7d-88f7-ec41533d4da3 68462-731 HUMAN PRESCRIPTION DRUG Hailey 24 Fe norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20171117 ANDA ANDA204847 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-733_88fd7961-5dee-4b32-9a4c-b1aec7d16b63 68462-733 HUMAN PRESCRIPTION DRUG drospirenone and ethinyl estradiol drospirenone and ethinyl estradiol KIT 20160325 ANDA ANDA204848 Glenmark Pharmaceuticals Inc., USA N 20181231 68462-746_4ed459ba-f00e-493b-af27-76dab8dcd990 68462-746 HUMAN PRESCRIPTION DRUG acyclovir acyclovir OINTMENT TOPICAL 20170731 ANDA ANDA205510 Glenmark Pharmaceuticals Inc., USA ACYCLOVIR 50 mg/g DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68462-792_264138c1-9e5f-45ef-be87-79ca97c989d9 68462-792 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CAPSULE ORAL 20161223 ANDA ANDA208279 Glenmark Pharmaceuticals Inc., USA TRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 68462-797_32b40228-4292-46e0-9cb4-5de3e117172f 68462-797 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20170822 ANDA ANDA208320 Glenmark Pharmaceuticals Inc., USA TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-798_32b40228-4292-46e0-9cb4-5de3e117172f 68462-798 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide OINTMENT TOPICAL 20160722 ANDA ANDA206379 Glenmark Pharmaceuticals Inc., USA TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68462-799_aee696ad-9b16-42db-a6ac-49932efb9fa5 68462-799 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide OINTMENT TOPICAL 20160623 ANDA ANDA208300 Glenmark Pharmaceuticals Inc., USA NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68470-1001_41f362a0-4996-42fb-8ca2-3b4f1ca7cbcd 68470-1001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20051111 UNAPPROVED MEDICAL GAS Super Care Inc OXYGEN 99 L/100L E 20171231 68472-028_b84ce3ef-a468-413c-ad33-3a4e67ad5c09 68472-028 HUMAN OTC DRUG Botanics Complexion Refining Day Moisture Lotion Sunscreen SPF 12 Octinoxate and Avobenzone LOTION TOPICAL 20100127 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE 3.75; 2.25 mL/75mL; mL/75mL E 20171231 68472-049_3e1b23c3-3ef8-4876-ab8b-843f4cfe03cb 68472-049 HUMAN OTC DRUG Botanics Daily Hand Therapy Sunscreen SPF 10 Octinoxate and Avobenzone CREAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE 3; 1.5 mL/75mL; mL/75mL E 20171231 68472-056_baf9148b-fb54-48ef-a82f-f0a3d66b4822 68472-056 HUMAN OTC DRUG BOTANICS FACE RENEWAL CREAM SUNSCREEN SPF 15 OCTINOXATE AND AVOBENZONE CREAM TOPICAL 20100203 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE 3; 1.5 mL/50mL; mL/50mL E 20171231 68472-057_e943640c-90ec-4636-afe6-356b4dd33945 68472-057 HUMAN OTC DRUG BOTANICS FACE LIFT FIRMING CREAM SUNSCREEN SPF 10 OCTINOXATE, AVOBENZONE AND OCTISALATE CREAM TOPICAL 20100222 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE; OCTISALATE 3.75; 1.5; 1.25 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-060_56965549-2268-4282-9a18-4fe4d32b9296 68472-060 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 New Ivory 10 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-062_069b2791-f716-4e6e-99b3-efdc26b038e7 68472-062 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Blonde 20 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-063_6cdf56cd-53a4-4258-8164-406ed224f568 68472-063 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Almond 30 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-066_fc0d5d03-c54e-4bdd-96f2-bc03cfbb947c 68472-066 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Vanilla 25 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-067_964b87c9-42d7-46c8-93f4-28b39e087b79 68472-067 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Truffle 50 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-069_48b4dcec-cfe1-484d-bfcf-4a7e2a415f51 68472-069 HUMAN OTC DRUG No7 Soft and Sheer Tinted Moisturiser Fair Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100305 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; .95 mL/50mL; mL/50mL E 20171231 68472-070_208ae123-310c-40eb-96aa-d169115cf0d0 68472-070 HUMAN OTC DRUG No7 Soft and Sheer Tinted Moisturiser Medium Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100305 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; .95 mL/50mL; mL/50mL E 20171231 68472-071_0108adde-d97f-4904-bce7-83605ad03ea9 68472-071 HUMAN OTC DRUG No7 Soft and Sheer Tinted Moisturiser Dark Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100305 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 2.5; .95 mL/50mL; mL/50mL E 20171231 68472-072_b5c376ef-e8a3-4f6a-b513-2bf5624595a3 68472-072 HUMAN OTC DRUG No7 Advanced Hydration Day Cream Sunscreen SPF 12 Octinoxate and Avobenzone CREAM TOPICAL 20091203 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE 2.5; 1.5 mL/50mL; mL/50mL E 20171231 68472-073_b4c0b7db-4845-4504-b965-271b3d9a94f9 68472-073 HUMAN OTC DRUG No7 Time Resisting Day Cream Sunscreen SPF 12 Octinoxate and Avobenzone CREAM TOPICAL 20091208 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE 2.5; 1.25 mL/50mL; mL/50mL E 20171231 68472-074_fe204e2f-8eb3-4a47-a5a6-508bc3eb99fd 68472-074 HUMAN OTC DRUG Botanics Day Moisture Sunscreen SPF 12 Octinoxate, Avobenzone and Octisalate CREAM TOPICAL 20100225 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE; OCTISALATE 3.75; 1.5; 1.25 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-075_8ff99d51-0e1f-4854-813d-31a4d3eed7b3 68472-075 HUMAN OTC DRUG No7 Lifting and Firming Day Sunscreen SPF 8 Octinoxate, Avobenzone and Octisalate EMULSION TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE; OCTISALATE 3.75; 1.5; 1 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-077_2b0c3b4e-34ef-4d95-be8b-e68f3508ad2b 68472-077 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Porcelain 05 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-078_c56c486d-9d17-4f54-bb67-b3969f856fd3 68472-078 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 New Ivory 10 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-079_ddb6adde-e0bf-485d-8361-8f389e75c8ea 68472-079 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Nude 15 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-080_2e2e580d-79d3-44d1-a53a-7dfa9fdea2b1 68472-080 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Blonde 20 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100111 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-081_689ceca5-95fb-4134-90ca-a77337121bdb 68472-081 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Vanilla 25 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-082_93323e81-3ad1-4b49-9d2c-6c43ac357a54 68472-082 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Almond 35 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100111 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-083_f18b20b5-5fc9-49cb-aadb-f767799669fa 68472-083 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Walnut 45 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-084_5780f42e-69f8-4742-a934-fed281b6ad03 68472-084 HUMAN OTC DRUG No7 Lifting and Firming Foundation Sunscreen SPF 15 Truffle 50 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100125 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-088_581733b5-767d-4adf-9baf-e4e3b2a58d68 68472-088 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 05 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-089_d9f074c3-f0c7-44a2-8222-e88b770c9352 68472-089 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Buff 15 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-090_02a34595-7f97-4c08-9965-2b1ca0c2d0b4 68472-090 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Suede 40 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-091_8c5f665d-4b60-40c8-8635-fe9861f109ca 68472-091 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Espresso 45 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-092_c0afb538-57bb-4ea6-9ab2-4b0888760583 68472-092 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Tan 35 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-093_a9ede626-6d99-496c-9cce-47eedfa547b1 68472-093 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Cocoa 55 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-094_b14b538b-ba15-4180-a1d5-d990fedc19e9 68472-094 HUMAN OTC DRUG No7 Stay Perfect Foundation Sunscreen SPF 15 Mocha 60 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100316 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-095_4d7e37f1-cc33-4ab2-8ff0-e9641d00d362 68472-095 HUMAN OTC DRUG No7 Radiant Glow Foundation Sunscreen SPF 15 Cream 05 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100324 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-096_e6a5a4ea-c0dd-4295-9f13-c086ed1b805f 68472-096 HUMAN OTC DRUG No7 Radiant Glow Foundation Sunscreen SPF 15 Buff 15 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100324 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-097_8cf10399-edd8-4d8b-89d5-6a10ae1debc8 68472-097 HUMAN OTC DRUG No7 Radiant Glow Foundation Sunscreen SPF 15 Suede 40 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100324 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-098_cd9ae219-8d48-4cf2-b0a7-04bf1ac39ddb 68472-098 HUMAN OTC DRUG No7 Radiant Glow Foundation Sunscreen SPF 15 Cocoa 55 Octinoxate and Titanium Dioxide EMULSION TOPICAL 20100324 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 mL/30mL; mL/30mL E 20171231 68472-099_bd355393-0a28-4ce0-ba32-fb588a9c2982 68472-099 HUMAN OTC DRUG BOTANICS TRIPLE ACTION DAY MOISTURE CREAM SUNSCREEN SPF 15 OCTINOXATE AND AVOBENZONE CREAM TOPICAL 20100120 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE 2.25; 1.5 mL/50mL; mL/50mL E 20171231 68472-100_c20ef608-54c8-4cf1-94d4-9a6eb42b5298 68472-100 HUMAN OTC DRUG No7 Protect and Perfect Day Cream Sunscreen SPF 15 Avobenzone , Octinoxate and Octisalate EMULSION TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE; OCTISALATE 3; 1.5; 1.25 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-101_bc37ce36-982d-4726-ad5b-aa0aa9c68355 68472-101 HUMAN OTC DRUG No7 Protect and Perfect Hand Cream Sunscreen SPF 15 Octinoxate, Avobenzone and Octisalate CREAM TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE; OCTISALATE 5.625; 2.25; 1.5 mL/75mL; mL/75mL; mL/75mL E 20171231 68472-102_2a56fde5-475d-4449-8c84-9ac076774c9b 68472-102 HUMAN OTC DRUG No7 Rebalancing Day Fluid Sunscreen SPF 15 Octinoxate and Avobenzone and Ensulizole LOTION TOPICAL 20091204 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE; ENSULIZOLE 6; 2; 2 mL/100mL; mL/100mL; mL/100mL E 20171231 68472-103_088d00b8-1da6-4637-abd1-e416399b5e3d 68472-103 HUMAN OTC DRUG No7 Protect and Perfect Skincare System Day Sunscreen SPF 15 Octinoxate, Avobenzone and Octisalate EMULSION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE; OCTISALATE 3; 1.5; 1.25 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-104_072059a5-0135-4222-9968-a20f24bcad2d 68472-104 HUMAN OTC DRUG No7 Lifting and Firming Skincare System Day Sunscreen SPF 8 Avobenzone, Octinoxate and Octisalate EMULSION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; AVOBENZONE; OCTISALATE 3.75; 1.5; 1 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-105_15eb367a-9154-44dd-99f1-a2a995057523 68472-105 HUMAN OTC DRUG No7 Beautiful Skin Day Normal Oily Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-106_2fcc888b-ba01-4e62-9710-481764748332 68472-106 HUMAN OTC DRUG No7 Beautiful Skin day Normal Dry Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-107_8d304fbb-7082-4912-bf04-196d3bae803c 68472-107 HUMAN OTC DRUG No7 Beautiful Skin Day Dry Very Dry Sunscreen Broad Spectrum SPF 15 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-108_6c38b673-07f7-43a7-974e-ec172a0c7e85 68472-108 HUMAN OTC DRUG No7 Beautiful Skin Oil Free Skin Protector All Skin Types SPF 25 Avobenzone, Octisalate and Octocrylene CREAM TOPICAL 20120502 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1.75; 3.25 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-109_55d85b4c-bc8f-4dab-9f92-0670e18ae36f 68472-109 HUMAN OTC DRUG No7 Protect and Perfect Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE 1.5; 3; 1.25 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-110_4791f277-99bc-4ba4-a238-54b8e0d9e4cb 68472-110 HUMAN OTC DRUG No7 Lift and Luminate Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octocrylene CREAM TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5; 2.5; .5 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-111_25eb489f-ac73-4e84-9397-88fb9effcfc8 68472-111 HUMAN OTC DRUG No7 Protect and Perfect Hand Cream Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTISALATE 2.25; 5.625; 1.5 mL/75mL; mL/75mL; mL/75mL E 20171231 68472-114_a315a37b-81c7-45dc-bd58-fd51d54f92fd 68472-114 HUMAN OTC DRUG No7 Lift and Luminate Day Sunscreen Broad Spectrum SPF 15 Avobenzone, Octinoxate, Octocrylene EMULSION TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5; 2.5; .5 mL/50mL; mL/50mL; mL/50mL E 20171231 68472-117_bcfa06d4-6751-4990-9c09-7bc38489a4d2 68472-117 HUMAN PRESCRIPTION DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Calico OCTINOXATE EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g E 20171231 68472-118_1fd70fad-163f-4f1e-9194-5452e451e0fb 68472-118 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g E 20171231 68472-119_9cda6ede-594b-4caf-bbf2-b1aaf2de333b 68472-119 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g E 20171231 68472-120_0e00ba2f-71f5-473a-b930-4dd5a256800a 68472-120 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g E 20171231 68472-121_2884016a-e302-4364-8d71-3f3e50c40e9a 68472-121 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g E 20171231 68472-122_01bf7485-87ad-40b0-99c3-d2fe7ab6f27d 68472-122 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Wheat OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g E 20171231 68472-123_e0f06191-8954-4d5f-a6d9-b8c677d2d739 68472-123 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Honey OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g E 20171231 68472-124_79d6ee52-b386-4732-bbcc-217545c33311 68472-124 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Mocha OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g E 20171231 68472-125_002162bf-1086-4491-94c4-4f67bb81e736 68472-125 HUMAN OTC DRUG No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Ebony OCTINOXATE EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 1.5 g/30g E 20171231 68472-126_90a573b2-aac5-433b-8be9-3283d919d2df 68472-126 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Calico Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g E 20171231 68472-127_c94cbbf3-4f0d-4aa5-a19b-373dc34a1abd 68472-127 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g E 20171231 68472-128_b06de144-d8ff-4116-8099-ae8f83e210ff 68472-128 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g E 20171231 68472-129_406f8f5a-75a7-4eac-a53f-05ad332b0dab 68472-129 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g E 20171231 68472-130_ed2a2cb7-17ae-4127-ad9a-568aec5153b2 68472-130 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g E 20171231 68472-131_f356851f-0259-46f4-b5dd-fe7aadb356a3 68472-131 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Wheat Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g E 20171231 68472-132_43dc78ed-5236-4fa8-a6d0-ee0844f0f730 68472-132 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Mocha Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g E 20171231 68472-133_7354c9b3-8b3b-4678-8bba-0b996b43b893 68472-133 HUMAN OTC DRUG No7 Lift and Luminate Foundation Sunscreen Broad Spectrum SPF 15 Ebony Octinoxate EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE 2.25 g/30g E 20171231 68472-134_c72b87cb-710b-4e79-b0fb-cb5202af3fad 68472-134 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g E 20171231 68472-135_8bd3e2f3-a821-4017-9318-a80dd1d3b752 68472-135 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g E 20171231 68472-136_23c52464-241a-454d-b22a-5f4499d4d246 68472-136 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g E 20171231 68472-137_1dbf699e-be1f-4bf3-b2fa-d96a8f671f9d 68472-137 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g E 20171231 68472-138_4e5baf67-7194-46f9-bf8f-c76b86e2f3d0 68472-138 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Wheat Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g E 20171231 68472-139_87b2faa3-3ae1-4123-8477-cade940866f9 68472-139 HUMAN OTC DRUG No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Mocha Octinoxate and Titanium Dioxide EMULSION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTINOXATE; TITANIUM DIOXIDE 1.5; .48 g/30g; g/30g E 20171231 68472-140_6706ceca-3443-47c1-859c-f38f4dc2c1ca 68472-140 HUMAN OTC DRUG No7 Dual Action Tinted Moisturiser Fair Avobenzone, Octisalate and Octocrylene EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g E 20171231 68472-141_aee6a64c-183b-4dc4-b9b6-de9e98fbdc59 68472-141 HUMAN OTC DRUG No7 Dual Action Tinted Moisturiser Medium Avobenzone, Octisalate and Octocrylene EMULSION TOPICAL 20121029 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE 1.5; 1; 2 g/50g; g/50g; g/50g E 20171231 68472-159_1f793a15-0adf-4d94-b53b-9dcedf799621 68472-159 HUMAN OTC DRUG No7 CC Cream Light Octinoxate, Octocrylene EMULSION TOPICAL 20140430 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTOCRYLENE; OCTINOXATE 3.2; 3 g/40g; g/40g E 20171231 68472-160_689749bd-595c-4302-a4e5-e6814e3379a0 68472-160 HUMAN OTC DRUG No7 CC Cream Medium Octinoxate, Octocrylene EMULSION TOPICAL 20140430 OTC MONOGRAPH NOT FINAL part352 Boots Retail USA Inc OCTOCRYLENE; OCTINOXATE 3.2; 3 g/40g; g/40g E 20171231 68472-234_5f3b2c58-c3d3-50e4-e053-2a91aa0a33c7 68472-234 HUMAN OTC DRUG YourGoodSkin Active Treatment Tonic Salicylic Acid LIQUID TOPICAL 20180201 OTC MONOGRAPH FINAL part333D BOOTS RETAIL USA INC SALICYLIC ACID 5 mg/mL N 20191231 68472-235_64296325-c2e2-2fbd-e053-2a91aa0a7ed3 68472-235 HUMAN OTC DRUG YourGoodSkin Anti-Acne Base Salicylic Acid LOTION TOPICAL 20171212 OTC MONOGRAPH FINAL part333D BOOTS RETAIL USA INC SALICYLIC ACID 10 mg/mL N 20191231 68472-236_6429872b-bb1d-a235-e053-2991aa0a25f7 68472-236 HUMAN OTC DRUG YourGoodSkin Calming Cleanser Salicylic Acid CREAM TOPICAL 20171217 OTC MONOGRAPH FINAL part333D BOOTS RETAIL USA INC SALICYLIC ACID 10 mg/mL N 20191231 68472-237_6429872b-bb2a-a235-e053-2991aa0a25f7 68472-237 HUMAN OTC DRUG YourGoodSkin Rapid Rescue Treatment Salicylic Acid GEL TOPICAL 20171219 OTC MONOGRAPH FINAL part333D BOOTS RETAIL USA INC SALICYLIC ACID 20 mg/mL N 20191231 68472-238_6428f7a5-bc13-5f4c-e053-2a91aa0a3c9d 68472-238 HUMAN OTC DRUG YourGoodSkin Blackhead Clearing Scrub Salicylic Acid CREAM TOPICAL 20170307 OTC MONOGRAPH FINAL part333D BOOTS RETAIL USA INC SALICYLIC ACID 10 mg/mL N 20191231 68475-002_4c768a55-a0b3-4217-bdfb-37cb2ab39f7a 68475-002 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171208 ANDA ANDA206071 Navinta LLC METHOCARBAMOL 100 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68479-000_7d487462-89bc-4a73-989d-cad0eae0614f 68479-000 HUMAN OTC DRUG Solar Defense Booster SPF50 Avobenzone and Octinoxate LOTION TOPICAL 20120213 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE 30; 70 mg/mL; mg/mL N 20181231 68479-005_e07cdb00-e54a-411e-9e9d-5e747f9ffc14 68479-005 HUMAN OTC DRUG Concealing Spot Treatment SULFUR LOTION TOPICAL 20140422 OTC MONOGRAPH FINAL part333D Dermalogica, Inc. SULFUR 50 mg/mL N 20181231 68479-009_f3bda8f6-6898-4818-bdfb-c01eca8b7516 68479-009 HUMAN OTC DRUG Redness Relief Primer SPF20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20140321 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. TITANIUM DIOXIDE; ZINC OXIDE 30; 85 mg/mL; mg/mL N 20181231 68479-012_bce11406-0a51-4457-8f26-aa0360f752ff 68479-012 HUMAN OTC DRUG Protection 50 Sport Avobenzone and Octinoxate LOTION TOPICAL 20150925 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE 30; 75 mg/mL; mg/mL N 20181231 68479-013_18110e4e-ca8b-413f-b8d3-27908859ccd7 68479-013 HUMAN OTC DRUG Sebum Clearing Masque Salicylic Acid LOTION TOPICAL 20110513 OTC MONOGRAPH FINAL part358H Dermalogica SALICYLIC ACID 5 mg/mL N 20181231 68479-040_3d38bffa-f447-48b8-9507-d875cb278bfc 68479-040 HUMAN OTC DRUG Clearing Skin Wash Salicylic Acid LIQUID TOPICAL 20091230 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 5 mg/mL N 20181231 68479-101_451cd63f-93e7-4fad-bff3-2a9ce8684fde 68479-101 HUMAN OTC DRUG Breakout Clearing Foaming Wash Salicylic Acid LIQUID TOPICAL 20130513 OTC MONOGRAPH FINAL part358H Dermalogica SALICYLIC ACID 5 mg/mL N 20181231 68479-110_5d22473d-b376-4f2a-b54c-85c1ec78577a 68479-110 HUMAN OTC DRUG Oil Free Matte SPF 30 Avobenzone, Homosalate, Octisalate, and Oxybenzone LOTION TOPICAL 20120216 OTC MONOGRAPH FINAL part352 Dermalogica AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 30; 80; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68479-120_03728265-8b8d-43da-87fc-9e48c7fc0f3b 68479-120 HUMAN OTC DRUG UltraSensitive Tint SPF 30 Titanium Dioxide LOTION TOPICAL 20120314 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 68479-130_adb2dff4-e406-4123-9624-2d0c12bcb6ef 68479-130 HUMAN OTC DRUG SkinPerfect Primer SPF 30 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20120213 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. TITANIUM DIOXIDE; ZINC OXIDE 40; 140 mg/mL; mg/mL N 20181231 68479-140_539d880a-3bfd-4912-af64-4efe8b8bd3ec 68479-140 HUMAN OTC DRUG Oil Clearing Matte Moisturizer Avobenzone, Octinoxate, OXYBENZONE, and Octisalate LOTION TOPICAL 20130829 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE; OXYBENZONE; OCTISALATE 25; 60; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68479-150_e9be18c5-5b52-4187-9b70-e894fb8c33c9 68479-150 HUMAN OTC DRUG Super Sensitive Shield SPF 30 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20120305 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. TITANIUM DIOXIDE; ZINC OXIDE 70; 90 mg/mL; mg/mL N 20181231 68479-160_d00ecad9-7ca8-4d61-a84b-3894c8f9a99e 68479-160 HUMAN OTC DRUG Breakout Clearing Daytime Treatment Benzoyl Peroxide LOTION TOPICAL 20130604 OTC MONOGRAPH FINAL part333D Dermalogica, Inc. BENZOYL PEROXIDE 25 mg/mL N 20181231 68479-201_4a5b3b50-dc18-4662-be96-2c8abb99870e 68479-201 HUMAN OTC DRUG Sheer Tint SPF20 - Light Zinc Oxide and Octinoxate LOTION TOPICAL 20150122 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. ZINC OXIDE; OCTINOXATE 95; 45 mg/mL; mg/mL N 20181231 68479-202_a428575c-cefa-4f1d-8712-faf36371ae8c 68479-202 HUMAN OTC DRUG Breakout Clearing Emergency Spot Fix Benzoyl Peroxide LOTION TOPICAL 20130603 OTC MONOGRAPH FINAL part333D Dermalogica, Inc. BENZOYL PEROXIDE 50 mg/mL N 20181231 68479-213_78139a5a-f5bf-4a31-9e16-e95371b0e9d9 68479-213 HUMAN OTC DRUG PureLight SPF50 Avobenzone and Octinoxate LOTION TOPICAL 20140218 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE 30; 75 mg/mL; mg/mL N 20181231 68479-230_f245ca49-37d6-4fee-9d1a-bbf838030c47 68479-230 HUMAN OTC DRUG Protection 50 Body Avobenzone and Octinoxate LOTION TOPICAL 20130808 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE 30; 75 mg/mL; mg/mL N 20181231 68479-301_4a5b3b50-dc18-4662-be96-2c8abb99870e 68479-301 HUMAN OTC DRUG Sheer Tint SPF20 - Dark Zinc Oxide and Octinoxate LOTION TOPICAL 20150122 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. ZINC OXIDE; OCTINOXATE 95; 45 mg/mL; mg/mL N 20181231 68479-312_dae6a0bd-aebb-45af-bc39-07db70052c10 68479-312 HUMAN OTC DRUG Breakout Clearing All Over Toner Salicylic Acid LIQUID TOPICAL 20130905 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 10 mg/mL N 20181231 68479-313_1278f223-284b-4de2-a570-b7fb0394aa41 68479-313 HUMAN OTC DRUG Breakout Clearing Overnight Treatment Salicylic Acid LOTION TOPICAL 20130906 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 20 mg/mL N 20181231 68479-318_8a5f41ee-bc8d-445b-a988-a579ec0172b2 68479-318 HUMAN OTC DRUG Dynamic Skin Recovery SPF 50 Avobenzone and Octinoxate LOTION TOPICAL 20131209 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE 30; 75 mg/mL; mg/mL N 20181231 68479-360_8296bbf4-b9ea-4037-ab3c-9a9458575188 68479-360 HUMAN OTC DRUG Total Eye Care SPF 15 Titanium Dioxide LOTION TOPICAL 20120329 OTC MONOGRAPH FINAL part352 Dermalogica TITANIUM DIOXIDE 45 mg/mL N 20181231 68479-411_3375a90f-3667-4e8f-be9a-cd950be24242 68479-411 HUMAN OTC DRUG Clearing Mattifier Salicylic Acid LOTION TOPICAL 20090417 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 20 mg/mL N 20181231 68479-503_e6fcc8a4-dc13-4810-9d80-fcf64e418473 68479-503 HUMAN OTC DRUG Special Clearing Booster Benzoyl Peroxide LIQUID TOPICAL 20110922 OTC MONOGRAPH FINAL part333D Dermalogica, Inc. BENZOYL PEROXIDE 50 mg/mL N 20181231 68479-706_62468211-f4d7-4ee3-8905-89633321a074 68479-706 HUMAN OTC DRUG Overnight Clearing Salicylic Acid GEL TOPICAL 20070501 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 20 mg/mL N 20181231 68479-800_a42ae7d9-be11-4911-aec3-a78921bda29a 68479-800 HUMAN OTC DRUG Daily Defense SPF 15 Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20120413 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 30; 65; 30; 35 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68479-801_238d04ab-2e87-4d38-825d-1cc331c26e02 68479-801 HUMAN OTC DRUG Dynamic Skin Recovery SPF 50 Avobenzone LOTION TOPICAL 20140317 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. AVOBENZONE 30 mg/mL N 20181231 68479-804_81a1794d-e7be-4ae1-8627-9bd22ec08163 68479-804 HUMAN OTC DRUG MediBac Clearing Complex Salicylic Acid LIQUID TOPICAL 20070509 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 5 mg/mL N 20181231 68479-808_9be73424-6777-43b6-b8e1-ab0e425bf3dd 68479-808 HUMAN OTC DRUG Oil Control Salicylic Acid LOTION TOPICAL 20031204 OTC MONOGRAPH FINAL part358H Dermalogica, Inc. SALICYLIC ACID 10 mg/mL N 20181231 68479-901_4a5b3b50-dc18-4662-be96-2c8abb99870e 68479-901 HUMAN OTC DRUG Sheer Tint SPF20 - Medium Zinc Oxide and Octinoxate LOTION TOPICAL 20150122 OTC MONOGRAPH FINAL part352 Dermalogica, Inc. ZINC OXIDE; OCTINOXATE 95; 45 mg/mL; mg/mL N 20181231 68511-350_0588618d-ba35-4588-a6f6-bba696427df2 68511-350 HUMAN OTC DRUG Mayinglong Hemorrhoids Zinc Oxide SUPPOSITORY RECTAL 20090715 OTC MONOGRAPH FINAL part346 Mayinglong Pharmaceutical Group Co., Ltd ZINC OXIDE 1.7 g/1 E 20171231 68511-993_5c76634d-2df4-7d1b-e053-2a91aa0acbaf 68511-993 HUMAN OTC DRUG MAYINGLONG HEMORRHOIDS Zinc Oxide, Petrolatum, Lanolin OINTMENT TOPICAL 20031215 OTC MONOGRAPH FINAL part346 Mayinglong Pharmaceutical Group Co Ltd ZINC OXIDE; PETROLATUM 350; 7850 mg/10000mg; mg/10000mg N 20181231 68515-001_45710f8c-3d88-4154-b790-4b0698cb0013 68515-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20110103 UNAPPROVED MEDICAL GAS American Home Respiratory Care, Inc. OXYGEN 992 mL/L E 20171231 68516-3201_168776a0-b07c-494d-b0d9-f25a6b36ac01 68516-3201 PLASMA DERIVATIVE Profilnine factor ix complex KIT INTRAVENOUS 19810720 BLA BLA102476 GRIFOLS USA, LLC N 20191231 68516-3202_168776a0-b07c-494d-b0d9-f25a6b36ac01 68516-3202 PLASMA DERIVATIVE Profilnine factor ix complex KIT INTRAVENOUS 19810720 BLA BLA102476 GRIFOLS USA, LLC N 20191231 68516-3203_168776a0-b07c-494d-b0d9-f25a6b36ac01 68516-3203 PLASMA DERIVATIVE Profilnine factor ix complex KIT INTRAVENOUS 19810720 BLA BLA102476 GRIFOLS USA, LLC N 20191231 68516-3207_168776a0-b07c-494d-b0d9-f25a6b36ac01 68516-3207 PLASMA DERIVATIVE Profilnine factor ix complex KIT INTRAVENOUS 19810720 BLA BLA102476 GRIFOLS USA, LLC N 20191231 68516-3208_168776a0-b07c-494d-b0d9-f25a6b36ac01 68516-3208 PLASMA DERIVATIVE Profilnine factor ix complex KIT INTRAVENOUS 19810720 BLA BLA102476 GRIFOLS USA, LLC N 20191231 68516-3209_168776a0-b07c-494d-b0d9-f25a6b36ac01 68516-3209 PLASMA DERIVATIVE Profilnine factor ix complex KIT INTRAVENOUS 19810720 BLA BLA102476 GRIFOLS USA, LLC N 20191231 68516-3601_a837704b-b0eb-430e-8b61-ed04fb527deb 68516-3601 PLASMA DERIVATIVE AlphaNine SD COAGULATION FACTOR IX (HUMAN) KIT INTRAVENOUS 19901231 BLA BLA103249 GRIFOLS USA, LLC N 20191231 68516-3602_a837704b-b0eb-430e-8b61-ed04fb527deb 68516-3602 PLASMA DERIVATIVE AlphaNine SD COAGULATION FACTOR IX (HUMAN) KIT INTRAVENOUS 19901231 BLA BLA103249 GRIFOLS USA, LLC N 20191231 68516-3603_a837704b-b0eb-430e-8b61-ed04fb527deb 68516-3603 PLASMA DERIVATIVE AlphaNine SD COAGULATION FACTOR IX (HUMAN) KIT INTRAVENOUS 19901231 BLA BLA103249 GRIFOLS USA, LLC N 20191231 68516-3607_a837704b-b0eb-430e-8b61-ed04fb527deb 68516-3607 PLASMA DERIVATIVE AlphaNine SD COAGULATION FACTOR IX (HUMAN) KIT INTRAVENOUS 19901231 BLA BLA103249 GRIFOLS USA, LLC N 20191231 68516-3608_a837704b-b0eb-430e-8b61-ed04fb527deb 68516-3608 PLASMA DERIVATIVE AlphaNine SD COAGULATION FACTOR IX (HUMAN) KIT INTRAVENOUS 19901231 BLA BLA103249 GRIFOLS USA, LLC N 20191231 68516-3609_a837704b-b0eb-430e-8b61-ed04fb527deb 68516-3609 PLASMA DERIVATIVE AlphaNine SD COAGULATION FACTOR IX (HUMAN) KIT INTRAVENOUS 19901231 BLA BLA103249 GRIFOLS USA, LLC N 20191231 68516-4601_0b11022d-acad-4933-a246-9c8edebd9b61 68516-4601 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC N 20191231 68516-4602_0b11022d-acad-4933-a246-9c8edebd9b61 68516-4602 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC N 20191231 68516-4603_0b11022d-acad-4933-a246-9c8edebd9b61 68516-4603 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC N 20191231 68516-4604_0b11022d-acad-4933-a246-9c8edebd9b61 68516-4604 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC N 20191231 68516-4609_0b11022d-acad-4933-a246-9c8edebd9b61 68516-4609 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC N 20191231 68516-4611_0b11022d-acad-4933-a246-9c8edebd9b61 68516-4611 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC N 20191231 68516-4612_0b11022d-acad-4933-a246-9c8edebd9b61 68516-4612 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC N 20191231 68516-4613_0b11022d-acad-4933-a246-9c8edebd9b61 68516-4613 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC N 20191231 68516-4614_0b11022d-acad-4933-a246-9c8edebd9b61 68516-4614 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC N 20191231 68516-4615_0b11022d-acad-4933-a246-9c8edebd9b61 68516-4615 PLASMA DERIVATIVE Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) KIT INTRAVENOUS 20070131 BLA BLA102475 GRIFOLS USA, LLC N 20191231 68516-5214_6e2b3d38-684d-4b48-90a0-2ed73f8ce12e 68516-5214 PLASMA DERIVATIVE ALBUTEIN ALBUMIN (HUMAN) INJECTION, SOLUTION INTRAVENOUS 19780815 BLA BLA102478 GRIFOLS USA, LLC ALBUMIN HUMAN 12.5 g/250mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20191231 68516-5215_ad888f5c-eb0a-4728-a285-4dfe2d8690a8 68516-5215 PLASMA DERIVATIVE ALBUTEIN ALBUMIN (HUMAN) INJECTION, SOLUTION INTRAVENOUS 19780815 BLA BLA102478 GRIFOLS USA, LLC ALBUMIN HUMAN 10 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20191231 68516-5216_3652f18e-27be-4e7f-899d-79d916e15571 68516-5216 PLASMA DERIVATIVE ALBUTEIN ALBUMIN (HUMAN) INJECTION, SOLUTION INTRAVENOUS 19780815 BLA BLA102478 GRIFOLS USA, LLC ALBUMIN HUMAN 12.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20191231 68540-001_08ad6ae6-e86d-45f9-a9ae-4fbf15b1c503 68540-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20020101 NDA NDA205820 Price Rite Medical Equipment, Inc. OXYGEN 990 mL/L N 20181231 68546-142_90b04c60-03b0-4e85-8ec3-591362f22e11 68546-142 HUMAN PRESCRIPTION DRUG Azilect Rasagiline Mesylate TABLET ORAL 20060710 NDA NDA021641 Teva Neuroscience, Inc. RASAGILINE MESYLATE .5 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 68546-170_a37dc60b-ba12-4cfa-a95a-93858fbae544 68546-170 HUMAN PRESCRIPTION DRUG Austedo Deutetrabenazine TABLET, COATED ORAL 20170412 NDA NDA208082 Teva Neuroscience, Inc. DEUTETRABENAZINE 6 mg/1 N 20181231 68546-171_a37dc60b-ba12-4cfa-a95a-93858fbae544 68546-171 HUMAN PRESCRIPTION DRUG Austedo Deutetrabenazine TABLET, COATED ORAL 20170412 NDA NDA208082 Teva Neuroscience, Inc. DEUTETRABENAZINE 9 mg/1 N 20181231 68546-172_a37dc60b-ba12-4cfa-a95a-93858fbae544 68546-172 HUMAN PRESCRIPTION DRUG Austedo Deutetrabenazine TABLET, COATED ORAL 20170412 NDA NDA208082 Teva Neuroscience, Inc. DEUTETRABENAZINE 12 mg/1 N 20181231 68546-229_90b04c60-03b0-4e85-8ec3-591362f22e11 68546-229 HUMAN PRESCRIPTION DRUG Azilect Rasagiline Mesylate TABLET ORAL 20060710 NDA NDA021641 Teva Neuroscience, Inc. RASAGILINE MESYLATE 1 mg/1 Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA] N 20181231 68546-317_f41f31d9-c863-4d6c-a9d9-ff92e968dfb7 68546-317 HUMAN PRESCRIPTION DRUG Copaxone Glatiramer Acetate INJECTION, SOLUTION SUBCUTANEOUS 20080428 NDA NDA020622 Teva Neuroscience, Inc. GLATIRAMER ACETATE 20 mg/mL N 20191231 68546-325_f41f31d9-c863-4d6c-a9d9-ff92e968dfb7 68546-325 HUMAN PRESCRIPTION DRUG Copaxone Glatiramer Acetate INJECTION, SOLUTION SUBCUTANEOUS 20140129 NDA NDA020622 Teva Neuroscience, Inc. GLATIRAMER ACETATE 40 mg/mL N 20191231 68547-501_423d1e7b-d47f-4fde-810c-cc2d159e1ded 68547-501 HUMAN PRESCRIPTION DRUG Giapreza angiotensin II INJECTION INTRAVENOUS 20180205 NDA NDA209360 La Jolla Pharmaceutical Company ANGIOTENSIN II 2.5 mg/mL Vasoconstrictor [EPC],Vasoconstriction [PE] N 20191231 68554-3025_ff5a9f04-1672-4eef-bfb0-df84189f8c8f 68554-3025 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20160304 ANDA ANDA090061 Hetero Labs Limited FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68554-3026_302da6ff-cec4-40fc-8635-a8c9c36df508 68554-3026 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130701 ANDA ANDA090060 Hetero Labs Limited FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68554-5061_12c87ec8-6af5-41bf-931a-8937e63cbad4 68554-5061 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20160823 ANDA ANDA204097 Hetero Labs Limited FEXOFENADINE HYDROCHLORIDE 30 mg/1 E 20171231 68554-5062_12c87ec8-6af5-41bf-931a-8937e63cbad4 68554-5062 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20160823 ANDA ANDA204097 Hetero Labs Limited FEXOFENADINE HYDROCHLORIDE 60 mg/1 E 20171231 68554-5063_12c87ec8-6af5-41bf-931a-8937e63cbad4 68554-5063 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine Hydrochloride TABLET, FILM COATED ORAL 20160823 ANDA ANDA204097 Hetero Labs Limited FEXOFENADINE HYDROCHLORIDE 180 mg/1 E 20171231 68570-704_3cc600e6-ec61-4d17-8065-66ed3615e41f 68570-704 HUMAN OTC DRUG shu uemura UV underbase SPF 20 sunscreen Octinoxate Titanium Dioxide LIQUID TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part352 Cosmelor Ltd OCTINOXATE; TITANIUM DIOXIDE .84; 1.428 mL/28mL; mL/28mL E 20171231 68570-744_59a7f077-a60a-4383-be34-5a0788848d87 68570-744 HUMAN OTC DRUG shu uemura UV under base mousse SPF 30 sunscreen Octinoxate Octisalate Octocrylene Titanium Dioxide AEROSOL, FOAM TOPICAL 20100201 OTC MONOGRAPH NOT FINAL part352 Cosmelor Ltd OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 4.6; 3.1; 1.9; 3.1 g/65g; g/65g; g/65g; g/65g E 20171231 68570-812_2cf51200-e9b6-4138-8270-6596371f6c73 68570-812 HUMAN OTC DRUG shu uemura face architect glow enhancing foundation SPF 26 Octinoxate Zinc Oxide POWDER TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 Cosmelor Ltd OCTINOXATE; ZINC OXIDE .8; .48 g/14g; g/14g E 20171231 68572-3005_98c58bd2-3b7d-4b5c-a9b7-a3257b1279c1 68572-3005 HUMAN OTC DRUG Karavita Face Essential with SPF 15 OXYBENZONE, AVOBENZONE, OCTINOXATE, and OCTISALATE LOTION TOPICAL 20151015 OTC MONOGRAPH FINAL part352 Kara Vita, Inc. OXYBENZONE; AVOBENZONE; OCTINOXATE; OCTISALATE 60; 30; 75; 50 mg/g; mg/g; mg/g; mg/g N 20181231 68572-6018_0ce89216-7930-47fe-a0cb-c5a74ca6b60e 68572-6018 HUMAN OTC DRUG KARA VITA Moisturizing Sunscreen with DNArescue OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, and HOMOSALATE CREAM TOPICAL 20151015 OTC MONOGRAPH FINAL part352 Kara Vita, Inc. OXYBENZONE; AVOBENZONE; OCTINOXATE; OCTISALATE; HOMOSALATE 60; 30; 75; 50; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 68586-219_27d738c3-6542-492c-85b6-e88ecd5077ec 68586-219 HUMAN OTC DRUG Villa Floriani Mint Purifying Day SPF 20 Avobenzone, Octocrylene, Octinoxate, and Octisalate LOTION TOPICAL 20160822 OTC MONOGRAPH FINAL part352 Originitalia srl AVOBENZONE; OCTOCRYLENE; OCTINOXATE; OCTISALATE 30; 90; 35; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68586-220_95a5fa6e-e4ab-4c5c-b1bd-4854e5b52aea 68586-220 HUMAN OTC DRUG Villa Floriani Chamomile Calming Day SPF 20 Avobenzone, Octocrylene, Octinoxate, and Octisalate LOTION TOPICAL 20160822 OTC MONOGRAPH FINAL part352 Originitalia srl AVOBENZONE; OCTOCRYLENE; OCTINOXATE; OCTISALATE 30; 90; 35; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68599-0123_1499cdee-5168-4659-a5d3-2a0c49da1d04 68599-0123 HUMAN OTC DRUG McKesson Fluoride Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20120217 OTC MONOGRAPH FINAL part355 McKesson Medical-Surgical SODIUM MONOFLUOROPHOSPHATE 2.43 mg/g N 20181231 68599-0201_05a1cbda-54a2-4b83-ab91-4993dad37f0d 68599-0201 HUMAN OTC DRUG THERA Antimicrobial Body Cleanser Benzalkonium Chloride LIQUID TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part333E McKesson Medical-Surgical Inc. BENZALKONIUM CHLORIDE 1.3 uL/mL N 20181231 68599-0202_5f1ea385-208a-4b71-9726-c621d01a5ae6 68599-0202 HUMAN OTC DRUG THERA Moisturizing Body Cleanser Dimethicone LIQUID TOPICAL 20110901 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. DIMETHICONE 17.5 uL/mL N 20181231 68599-0203_03cadffe-c466-417e-9bae-eb26381da4e0 68599-0203 HUMAN OTC DRUG THERA Dimethicone Body Shield Dimethicone CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. DIMETHICONE 50 uL/mL N 20181231 68599-0204_365bb9ee-b1ee-4ee2-8c39-d107b15debaf 68599-0204 HUMAN OTC DRUG THERA Moisturizing Body Shield Dimethicone CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. DIMETHICONE 15 mg/g N 20181231 68599-0205_12014396-6d05-40ed-a3c7-f60712562a32 68599-0205 HUMAN OTC DRUG THERA Calazinc Body Shield Zinc Oxide PASTE TOPICAL 20110901 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. ZINC OXIDE 200 mg/g N 20181231 68599-0206_5be983c4-c1bc-103d-e053-2991aa0a42c8 68599-0206 HUMAN OTC DRUG Antifungal Body Miconazole Nitrate CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part333C McKesson MICONAZOLE NITRATE 2 mg/100mL N 20181231 68599-0207_d7593af7-3af3-4e78-b62f-8afcfeba72cf 68599-0207 HUMAN OTC DRUG THERA Antifungal Body Miconazole Nitrate POWDER TOPICAL 20110901 OTC MONOGRAPH FINAL part333C McKesson Medical-Surgical Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 68599-0208_1e65e502-5c19-4837-ad6b-14fbf70de191 68599-0208 HUMAN OTC DRUG THERA Moisturizing Body Dimethicone CREAM TOPICAL 20110901 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. DIMETHICONE 17.5 uL/mL N 20181231 68599-1183_59774608-0cc4-4049-e053-2991aa0ac72e 68599-1183 HUMAN OTC DRUG Antibiotic Bacitracin Zinc OINTMENT TOPICAL 20170922 OTC MONOGRAPH FINAL part333B McKesson NEOMYCIN SULFATE; BACITRACIN ZINC; POLYMYXIN B SULFATE 5; 400; 5000 mg/g; [USP'U]/g; [USP'U]/g N 20181231 68599-1184_5bea95be-4374-3054-e053-2a91aa0a29ca 68599-1184 HUMAN OTC DRUG McKesson Bacitracin Zinc BACITRACIN ZINC OINTMENT TOPICAL 20160714 OTC MONOGRAPH FINAL part333B McKesson Medical-Surgical Inc. BACITRACIN ZINC 500 [iU]/g N 20181231 68599-1185_5bd276f2-52c3-1754-e053-2991aa0a3577 68599-1185 HUMAN OTC DRUG Skin Protectant Petrolatum OINTMENT TOPICAL 20171018 OTC MONOGRAPH FINAL part347 McKesson PETROLATUM 93.5 g/100g N 20181231 68599-1186_5bd694f8-b5ff-3ee6-e053-2a91aa0acfa3 68599-1186 HUMAN OTC DRUG Skin Protectant Petrolatum OINTMENT TOPICAL 20171018 OTC MONOGRAPH FINAL part347 McKesson PETROLATUM 93.5 g/100g N 20181231 68599-1187_5be6c0e8-6c0c-e181-e053-2a91aa0a4c7d 68599-1187 HUMAN OTC DRUG Skin Protectant Petrolatum OINTMENT TOPICAL 20171019 OTC MONOGRAPH FINAL part347 McKesson PETROLATUM 93.5 g/100g N 20181231 68599-1470_5beb0a51-deaf-6e53-e053-2991aa0adbde 68599-1470 HUMAN OTC DRUG Antifungal Miconazole Nitrate CREAM TOPICAL 20170526 OTC MONOGRAPH FINAL part333C McKesson MICONAZOLE NITRATE 2 mg/100mL N 20181231 68599-2301_5ef777a8-67ea-71b9-e053-2991aa0a1cb0 68599-2301 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20131009 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. HYDROGEN PEROXIDE 30 mg/mL N 20181231 68599-2302_5ef7c9cd-7811-dd7a-e053-2a91aa0a3d76 68599-2302 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20131009 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. ISOPROPYL ALCOHOL 700 mg/mL N 20181231 68599-2303_5beb5992-d24f-cc9f-e053-2991aa0a7393 68599-2303 HUMAN OTC DRUG Roll On Anti-Perspirant (Alcohol Free) ALUMINUM CHLOROHYDRATE SOLUTION TOPICAL 20130805 OTC MONOGRAPH FINAL part350 McKesson Medical-Surgical, Inc. ALUMINUM CHLOROHYDRATE .1 mg/mL N 20181231 68599-2304_5beb6d8d-1885-ee1c-e053-2991aa0afa5f 68599-2304 HUMAN OTC DRUG Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE SPRAY TOPICAL 20131009 OTC MONOGRAPH FINAL part350 McKesson Medical-Surgical Inc. ALUMINUM CHLOROHYDRATE 130 mg/mL N 20181231 68599-2305_5ef7b303-a965-04cf-e053-2a91aa0aa8ba 68599-2305 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20131114 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. HYDROGEN PEROXIDE 30 mg/mL N 20181231 68599-2306_652bc0d9-3b61-4098-8b35-52e6c25d0d51 68599-2306 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20131114 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. ISOPROPYL ALCOHOL 700 mg/mL N 20181231 68599-3500_4a9e8122-5350-0643-e054-00144ff8d46c 68599-3500 HUMAN OTC DRUG McKesson PVP Prep Solution Povidone-Iodine LIQUID TOPICAL 20161017 OTC MONOGRAPH NOT FINAL part333E McKesson Medical-Surgical POVIDONE-IODINE 1 mg/10mL N 20181231 68599-3501_4a17faca-ca11-4d91-e054-00144ff88e88 68599-3501 HUMAN OTC DRUG PVP Scrub Solution Povidone Iodine SOLUTION TOPICAL 20170303 OTC MONOGRAPH NOT FINAL part333E McKesson Medical-Surgical Inc. POVIDONE-IODINE 7.5 mg/1 N 20181231 68599-3502_4a9e8122-5350-0643-e054-00144ff8d46c 68599-3502 HUMAN OTC DRUG McKesson PVP Prep Solution Povidone-Iodine LIQUID TOPICAL 20161017 OTC MONOGRAPH NOT FINAL part333E McKesson Medical-Surgical POVIDONE-IODINE 1 mg/10mL N 20181231 68599-5201_2b015bf4-219d-4538-a534-df3d35cc1d20 68599-5201 HUMAN OTC DRUG Premium Hand Sanitizer ethanol GEL TOPICAL 20150109 OTC MONOGRAPH NOT FINAL part333A MCKESSON MEDICAL-SURGICAL INC. ALCOHOL 70 g/100g N 20181231 68599-5202_219d230d-9b65-4bd6-a227-28a830bc0990 68599-5202 HUMAN OTC DRUG Premium Hand Sanitizer with Aloe ethanol GEL TOPICAL 20150109 OTC MONOGRAPH NOT FINAL part333A MCKESSON MEDICAL-SURGICAL INC. ALCOHOL 70 g/100g N 20181231 68599-5203_249d0ea8-e54d-497f-87e9-fb1867f19f22 68599-5203 HUMAN OTC DRUG Antimicrobial Hand Triclosan SOAP TOPICAL 20141121 OTC MONOGRAPH NOT FINAL part333A MCKESSON MEDICAL-SURGICAL INC. TRICLOSAN .375 g/100mL N 20181231 68599-5204_4905796e-0674-4242-9dc8-bc6ab45cf3e6 68599-5204 HUMAN OTC DRUG Mckesson Hand Cleanse and Soothe with Aloe Chloroxylenol GEL TOPICAL 20150109 OTC MONOGRAPH NOT FINAL part333A Mckesson Medical-Surgical Inc. CHLOROXYLENOL .95 g/g N 20181231 68599-5205_5c4b8bfc-06c9-1eb2-e053-2a91aa0a4d0b 68599-5205 HUMAN OTC DRUG Foaming Instant Hand Sanitizer with Aloe ethanol GEL TOPICAL 20150109 OTC MONOGRAPH NOT FINAL part333A MCKESSON MEDICAL-SURGICAL INC. ALCOHOL 70 g/100g N 20181231 68599-5206_1a5b3b14-a5e0-424c-b3e3-e686a46a3f09 68599-5206 HUMAN OTC DRUG McKesson Foaming Hand Cleanse triclosan SOAP TOPICAL 20150219 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. TRICLOSAN .375 g/100g N 20181231 68599-5303_696c9d7c-6d15-4826-afb6-8b1a3b4f113b 68599-5303 HUMAN OTC DRUG Medi-Pak Performance Antimicrobial with Aloe CHLOROXYLENOL SOAP TOPICAL 20030101 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical Inc. CHLOROXYLENOL .95 mL/100mL N 20181231 68599-5312_797bf710-5d68-4cc3-a9b0-81eff4556d99 68599-5312 HUMAN OTC DRUG McKesson Skin Protectant ZINC OXIDE CREAM TOPICAL 20140424 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. ZINC OXIDE 50 mg/mL N 20181231 68599-5320_5ef80316-38d9-6b0d-e053-2a91aa0a9c77 68599-5320 HUMAN OTC DRUG McKesson Hand Sanitizer Alcohol GEL TOPICAL 20150227 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical ALCOHOL .62 mL/mL N 20181231 68599-5401_5e95fc22-f23b-b023-e053-2a91aa0a9eaa 68599-5401 HUMAN OTC DRUG Antiseptic Skin Cleanser CHLORHEXIDINE GLUCONATE SOLUTION TOPICAL 20170601 NDA NDA019125 McKesson Medical-Surgical CHLORHEXIDINE GLUCONATE 4 g/100mL N 20181231 68599-5501_58892abf-e0ba-83d9-e053-2a91aa0ad035 68599-5501 HUMAN OTC DRUG Antibacterial Benzethonium Chloride LIQUID TOPICAL 20170929 OTC MONOGRAPH NOT FINAL part333A McKesson BENZETHONIUM CHLORIDE .13 g/100mL N 20181231 68599-5502_588a89cd-9482-6163-e053-2991aa0a9e3d 68599-5502 HUMAN OTC DRUG Antibacterial Benzethonium Chloride LIQUID TOPICAL 20170929 OTC MONOGRAPH NOT FINAL part333A McKesson BENZETHONIUM CHLORIDE .13 g/100mL N 20181231 68599-5803_5ef777a8-67c8-71b9-e053-2991aa0a1cb0 68599-5803 HUMAN OTC DRUG Alcohol Disinfecting Wipe Alcohol SWAB TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical ALCOHOL 70 mL/1 N 20181231 68599-5804_5ef7b303-a956-04cf-e053-2a91aa0aa8ba 68599-5804 HUMAN OTC DRUG McKesson Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20100409 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical ISOPROPYL ALCOHOL .7 mL/mL N 20191231 68599-5804_5ef822af-c3c9-46e2-e053-2a91aa0a178e 68599-5804 HUMAN OTC DRUG McKesson Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20150619 OTC MONOGRAPH NOT FINAL part333A McKesson Medical-Surgical ISOPROPYL ALCOHOL .7 mL/mL N 20191231 68599-5806_5ef74e6a-52c0-46e9-e053-2991aa0a53e4 68599-5806 HUMAN OTC DRUG McKesson Obstetrical Antiseptic Towelette Benzalkonium Chloride SWAB TOPICAL 20160729 OTC MONOGRAPH NOT FINAL part333E McKesson Medical-Surgical BENZALKONIUM CHLORIDE .13 g/100g N 20181231 68599-5807_5ef777a8-67d8-71b9-e053-2991aa0a1cb0 68599-5807 HUMAN OTC DRUG McKesson Benzalkonium Chloride Towelette Benzalkonium Chloride SWAB TOPICAL 20160729 OTC MONOGRAPH NOT FINAL part333E McKesson Medical-Surgical BENZALKONIUM CHLORIDE .13 g/100g N 20181231 68599-6103_5f3a246d-89cb-c7fd-e053-2991aa0a0201 68599-6103 HUMAN OTC DRUG DERMA GRAN Aluminium Hydroxide OINTMENT TOPICAL 20131112 OTC MONOGRAPH FINAL part331 McKesson Medical-Surgical ALUMINUM HYDROXIDE .275 g/100g N 20181231 68599-6106_5f3a312a-c108-0205-e053-2991aa0afb61 68599-6106 HUMAN OTC DRUG DERMA GRAN GP Petrolatum OINTMENT TOPICAL 20131112 OTC MONOGRAPH FINAL part346 McKesson Medical-Surgical PETROLATUM 85 g/100g N 20181231 68599-6109_daf497d0-c518-488a-b1a8-46513dbe96dd 68599-6109 HUMAN OTC DRUG MEDI-PAK Zinc Oxide DRESSING TOPICAL 20100805 OTC MONOGRAPH FINAL part347 MCKESSON MEDICAL-SURGICAL ZINC OXIDE 25 g/1 E 20171231 68599-6110_d6649b1c-33bb-4daa-85e4-d5a0a33d9c6b 68599-6110 HUMAN OTC DRUG MEDI-PAK Zinc Oxide, Calamine DRESSING TOPICAL 20100805 OTC MONOGRAPH FINAL part347 MCKESSON MEDICAL-SURGICAL ZINC OXIDE; FERRIC OXIDE RED; ZINC OXIDE 25; .015; .985 g/1; g/1; g/1 E 20171231 68599-6111_5ef82bc8-b440-a867-e053-2991aa0a925c 68599-6111 HUMAN OTC DRUG McKesson Unna Boot 3 Zinc Oxide DRESSING TOPICAL 20140701 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical ZINC OXIDE 19.8 g/165g N 20181231 68599-6112_5ef82bc8-b42e-a867-e053-2991aa0a925c 68599-6112 HUMAN OTC DRUG McKesson Unna Boot with Calamine 3 Zinc Oxide and Ferric Oxide Red DRESSING TOPICAL 20140701 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical ZINC OXIDE; FERRIC OXIDE RED 4.95; .35 g/165g; g/165g N 20181231 68599-6113_5ef82bc8-b440-a867-e053-2991aa0a925c 68599-6113 HUMAN OTC DRUG McKesson Unna Boot 4 Zinc Oxide DRESSING TOPICAL 20140701 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical ZINC OXIDE 24.6 g/205g N 20181231 68599-6114_5ef82bc8-b42e-a867-e053-2991aa0a925c 68599-6114 HUMAN OTC DRUG McKesson Unna Boot with Calamine 4 Zinc Oxide and Ferric Oxide Red DRESSING TOPICAL 20140701 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical ZINC OXIDE; FERRIC OXIDE RED 6.15; .43 g/205g; g/205g N 20181231 68599-6201_46de56db-e8a1-7386-e054-00144ff88e88 68599-6201 HUMAN OTC DRUG Skin Protectant Petrolatum CREAM TOPICAL 20170105 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. PETROLATUM 43 g/100g N 20181231 68599-6202_5abf3dab-49ac-5e9e-e053-2991aa0a8657 68599-6202 HUMAN OTC DRUG Skin Protectant with Lanolin Lanolin CREAM TOPICAL 20170105 OTC MONOGRAPH FINAL part347 McKesson Medical-Surgical Inc. LANOLIN 50 g/100g N 20181231 68599-6203_5abe1b34-f71c-2a90-e053-2991aa0aded6 68599-6203 HUMAN OTC DRUG Skin Protectant with Lanolin Lanolin CREAM TOPICAL 20171004 OTC MONOGRAPH FINAL part347 McKesson LANOLIN 50 g/100g N 20181231 68599-6301_5524013a-e339-5f56-e054-00144ff88e88 68599-6301 HUMAN OTC DRUG Silver Nitrate Applicators Silver Nitrate Applicators SWAB TOPICAL 20170701 UNAPPROVED DRUG OTHER McKesson Medical-Surgical POTASSIUM NITRATE; SILVER NITRATE 25; 75 mg/1; mg/1 N 20181231 68599-8630_478d95ed-86a3-2465-e054-00144ff8d46c 68599-8630 HUMAN OTC DRUG Swab Povidone-Iodine SWAB TOPICAL 20170117 OTC MONOGRAPH FINAL part333C McKesson Medical-Surgical Inc. POVIDONE-IODINE 10 mg/1 N 20181231 68599-8635_47017f36-6d9d-47c5-e054-00144ff8d46c 68599-8635 HUMAN OTC DRUG Swabs Isopropyl Alcohol STICK TOPICAL 20170117 OTC MONOGRAPH FINAL part344 McKesson ISOPROPYL ALCOHOL 70 1/1001 N 20181231 68604-237_a5509979-d2b3-41eb-b16a-c5f6d12e1242 68604-237 HUMAN OTC DRUG Hand Kleen Foaming Instant Hand Sanitizer Benzethonium Chloride LIQUID TOPICAL 20121231 OTC MONOGRAPH NOT FINAL part333E Auto-Chlor System, LLC BENZETHONIUM CHLORIDE .2 g/100mL E 20171231 68605-2001_f21b567e-7251-4ab4-ad90-bce91c9c721e 68605-2001 HUMAN OTC DRUG END-ZIT SULFUR LOTION, AUGMENTED TOPICAL 20040420 OTC MONOGRAPH FINAL part333D ABBE Laboratories, Inc. SULFUR .05 g/mL E 20171231 68605-2002_f21b567e-7251-4ab4-ad90-bce91c9c721e 68605-2002 HUMAN OTC DRUG END-ZIT SULFUR LOTION, AUGMENTED TOPICAL 20040420 OTC MONOGRAPH FINAL part333D ABBE Laboratories, Inc. SULFUR .05 g/g E 20171231 68605-2003_f21b567e-7251-4ab4-ad90-bce91c9c721e 68605-2003 HUMAN OTC DRUG END-ZIT SULFUR LOTION, AUGMENTED TOPICAL 20040420 OTC MONOGRAPH FINAL part333D ABBE Laboratories, Inc. SULFUR .05 g/g E 20171231 68605-2006_f21b567e-7251-4ab4-ad90-bce91c9c721e 68605-2006 HUMAN OTC DRUG END-ZIT SULFUR LOTION, AUGMENTED TOPICAL 20040420 OTC MONOGRAPH FINAL part333D ABBE Laboratories, Inc. SULFUR .05 g/g E 20171231 68605-2007_e8302632-3e8c-4510-8283-a6f5df89f1d6 68605-2007 HUMAN OTC DRUG Grandma Els Diaper Rash Ointment OINTMENT TOPICAL 20150201 OTC MONOGRAPH FINAL part347 ABBE Laboratories, Inc. PETROLATUM; LANOLIN .7595; .155 g/g; g/g N 20191231 68609-575_5b0775d8-0e68-44cc-8b9f-c7597d35d5a4 68609-575 HUMAN OTC DRUG Sani-Foam Instant Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20040131 OTC MONOGRAPH NOT FINAL part333 General Products & Supply, Inc. BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 68611-190_f5666989-d3b3-4737-b277-34b0445cecff 68611-190 HUMAN PRESCRIPTION DRUG Iluvien fluocinolone acetonide IMPLANT INTRAVITREAL 20141015 NDA NDA201923 Alimera Sciences, Inc. FLUOCINOLONE ACETONIDE .19 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68621-0031_63adb01e-9d3a-2a1a-e053-2a91aa0ab01a 68621-0031 HUMAN PRESCRIPTION DRUG Xadago safinamide mesylate TABLET, FILM COATED ORAL 20170508 NDA NDA207145 Catalent Germany Schorndorf GmbH SAFINAMIDE MESYLATE 100 mg/1 Monoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20191231 68624-001_d53ffba8-cd95-4923-8043-d64cfe582947 68624-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040101 UNAPPROVED MEDICAL GAS Tech Air of Naugatuck LLC OXYGEN 990 mL/L E 20171231 68624-002_60f5276e-521e-6093-e053-2991aa0a14f7 68624-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20051201 NDA NDA206024 Tech Air of Naugatuck, LLC NITROGEN 990 mL/L N 20181231 68624-003_60f5aaef-5753-a7a0-e053-2991aa0a069d 68624-003 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040101 NDA NDA206023 Tech Air of Naugatuck LLC OXYGEN 990 mL/L N 20181231 68634-0029_2a94857e-50e3-48f6-bfbc-25ac68d6ae5b 68634-0029 HUMAN OTC DRUG age renewal deep wrinkle moisturizer Homosalate, Octisalate, Oxybenzone, Avobenzone, Octocrylene CREAM TOPICAL 20100112 OTC MONOGRAPH FINAL part352 AMCOL Health and Beauty Solutions, Inc. HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE .1; .05; .02; .02; .015 g/g; g/g; g/g; g/g; g/g E 20171231 68634-0031_3d6d5909-5da6-4436-a39a-e7a3a2a3986e 68634-0031 HUMAN OTC DRUG age renewal firming and hydrating moisturizer Octinoxate, Octisalate, Oxybenzone, Zinc Oxide CREAM TOPICAL 20091222 OTC MONOGRAPH FINAL part352 AMCOL Health and Beauty Solutions, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE .075; .05; .04; .02 g/g; g/g; g/g; g/g E 20171231 68634-0032_e8bc0518-5921-4505-99fc-b8c4f30b58c6 68634-0032 HUMAN OTC DRUG Glycolic Day Cream SPF 30 Homosalate, Octisalate, Octocrylene, Oxybenzone, Avobenzone CREAM TOPICAL 20100104 OTC MONOGRAPH FINAL part352 AMCOL Health and Beauty Solutions, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE .1; .05; .02; .05; .03 mL/mL; mL/mL; mL/mL; mL/mL; mL/mL E 20171231 68634-050_8cc522b4-c4f9-40f6-b24c-f58ea9eb8b0c 68634-050 HUMAN OTC DRUG Sheltered Broad Spectrum SPF 55 Sunscreen homosalate, oxybenzone, octisalate, avobenzone, octocrylene LIQUID TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 AMCOL Health & Beauty Solutions, Inc. DBA HOMOSALATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 100; 60; 50; 30; 20 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 68634-051_e5da532f-240f-43de-8a67-30f86c44ede4 68634-051 HUMAN OTC DRUG Vividly Brilliant Perfecting Hydroquinone LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part358A AMCOL Health & Beauty Solutions, Inc. DBA HYDROQUINONE 40 g/2mL N 20181231 68634-052_4cc888dc-5eb7-4313-ae9b-90352d5c1f90 68634-052 HUMAN OTC DRUG Skin Pharmacy Advanced Sun Therapy Broad Spectrum SPF 30 Sun Homosalate, Octisalate, Avobenzone, Oxybenzone, Octocrylene LIQUID TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 AMCOL Health & Beauty Solutions, Inc. DBA HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE 40; 40; 30; 30; 20 g/2mL; g/2mL; g/2mL; g/2mL; g/2mL N 20181231 68634-053_6aa1bc4b-8606-4e03-8062-efc2f10416f5 68634-053 HUMAN OTC DRUG SkinPharmacy Advanced Sun Therapy Broad Spectrum SPF 50 Face homosalate, oxybenzone, octisalate, avobenzone, octocrylene LIQUID TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 AMCOL Health & Beauty Solutions, Inc. DBA HOMOSALATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 100; 60; 50; 30; 20 g/2mL; g/2mL; g/2mL; g/2mL; g/2mL N 20181231 68634-054_15f54cb0-4f74-494b-93f9-bf839c81a4b5 68634-054 HUMAN OTC DRUG Beauty 360 Accelerated Wrinkle Repair Moisturizer homosalate, octisalate, avobenzone, octocrylene LIQUID TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 AMCOL Health & Beauty Solutions, Inc. DBA HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 40; 40; 20; 20 g/2mL; g/2mL; g/2mL; g/2mL N 20181231 68634-055_5b3423a3-7e69-4a4a-b3ce-b8dc857efd05 68634-055 HUMAN OTC DRUG All Day Moisture with AHAs SPF 15 Broad Spectrum Sunscreen Homosalate, Octisalate, Oxybenzone, Avobenzone, Octocrylene LIQUID TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 AMCOL Health & Beauty Solutions, Inc. DBA HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 100; 50; 40; 20; 13 g/2mL; g/2mL; g/2mL; g/2mL; g/2mL N 20181231 68634-056_9c75bb55-628e-4a53-a181-e103b6dca019 68634-056 HUMAN OTC DRUG SkinPharmacy Advanced Anti-Aging Therapy Retinol Day Moisturizer SPF 30 homosalate, octisalate, avobenzone, octocrylene, oxybenzone LIQUID TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 AMCOL Health & Beauty Solutions, Inc. DBA HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE; OXYBENZONE 100; 50; 20; 15; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68634-057_74081f12-5dd9-4899-9c79-88e580b656ea 68634-057 HUMAN OTC DRUG SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID salicylic acid LIQUID TOPICAL 20140501 OTC MONOGRAPH FINAL part333D AMCOL Health & Beauty Solutions, Inc. DBA SALICYLIC ACID 20 g/2mL N 20181231 68634-058_9ac1aa59-1826-4501-9662-aae66dd7bc6c 68634-058 HUMAN OTC DRUG SKIN PHARMACY ADVANCED ACNE THERAPY PORE REFINING FACIAL MASK salicylic acid LIQUID TOPICAL 20160701 OTC MONOGRAPH FINAL part333D AMCOL Health & Beauty Solutions, Inc. DBA SALICYLIC ACID 5 g/2mL N 20181231 68634-062_72b7755f-10f7-405f-893e-52536e721ec1 68634-062 HUMAN OTC DRUG SkinPharmacy Advanced Anti-Aging Therapy Glycolic Day Moisturizer SPF 30 homosalate, octisalate, avobenzone, octocrylene, oxybenzone LOTION TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 AMCOL Health & Beauty Solutions, Inc. DBA HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE; OXYBENZONE 100; 50; 30; 20; 50 g/2mL; g/2mL; g/2mL; g/2mL; g/2mL N 20181231 68634-063_13aca11f-558b-4916-b2fa-6c87d34c5abb 68634-063 HUMAN OTC DRUG Age Renewal Firming octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide LOTION TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 AMCOL Health & Beauty Solutions, Inc. DBA OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 60; 50; 40; 39; 20 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 68634-064_2943c83f-45b4-44d0-aed1-25a8a5c9cdfe 68634-064 HUMAN OTC DRUG SKIN PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSER salicylic acid LIQUID TOPICAL 20140701 OTC MONOGRAPH FINAL part333D AMCOL Health & Beauty Solutions, Inc. DBA SALICYLIC ACID 20 g/2mL N 20181231 68634-067_c948108b-a725-4a89-9e82-dd618c74720e 68634-067 HUMAN OTC DRUG Skin Pharmacy Advanced Acne Therapy Kit salicylic acid, benzoyl peroxide KIT TOPICAL 20141001 OTC MONOGRAPH FINAL part333D AMCOL Health & Beauty Solutions, Inc. DBA N 20181231 68634-068_2899eda0-eccc-4180-9f5a-cf5af7e568be 68634-068 HUMAN OTC DRUG Skin Pharmacy Advanced Acne Therapy Targeted Treatment Wipes benzoyl peroxide SWAB TOPICAL 20140501 OTC MONOGRAPH FINAL part333D AMCOL Health & Beauty Solutions, Inc. DBA BENZOYL PEROXIDE 25 mg/mL N 20181231 68638-876_f9c7dde6-544b-405f-b287-77166e4d81b7 68638-876 HUMAN OTC DRUG Harmony High Foaming Antiseptic Hand and Body Wash CHLOROXYLENOL SOAP TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333E Ric Mar Industries, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 68639-0001_a2b0d552-5eba-4be3-9c34-5065f39814d9 68639-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20031013 UNAPPROVED MEDICAL GAS RX O2 Oxygen & Medical Equipment Supply OXYGEN 99 L/100L E 20171231 68642-575_3574c355-6af5-4779-84db-653af123d9a8 68642-575 HUMAN OTC DRUG Foam Magic Instant Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part333E Omega Industrial Supply, Inc. BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 68642-783_9db5510f-c646-48f6-8389-f38a5e6a6aa0 68642-783 HUMAN OTC DRUG Sani Wipes ALCOHOL CLOTH TOPICAL 20090801 OTC MONOGRAPH NOT FINAL part333 Omega Industrial Supply, Inc. ALCOHOL 620 mg/g E 20171231 68642-876_cbe7d682-b1b5-4e65-9517-7ab4625d09e2 68642-876 HUMAN OTC DRUG Healthy Hands Aloe Antiseptic Hand and Body Wash CHLOROXYLENOL SOAP TOPICAL 20170421 OTC MONOGRAPH NOT FINAL part333E Omega Industrial Supply, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 68645-020_f1102345-7a13-47d3-b7bc-8686b7ef5729 68645-020 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20110209 ANDA ANDA062505 Legacy Pharmaceutical Packaging DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68645-021_af206cfa-2d91-49e2-b60d-90a7348fb706 68645-021 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline hyclate TABLET, COATED ORAL 20100501 ANDA ANDA065095 Legacy Pharmaceutical Packaging DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68645-060_c87b05a1-82c0-4e4a-b144-6ef0e5665dd4 68645-060 HUMAN PRESCRIPTION DRUG Ciprofloxacin ciprofloxacin TABLET, FILM COATED ORAL 20110412 ANDA ANDA075817 Legacy Pharmaceutical Packaging CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68645-130_84918eb6-668e-4122-9e84-b6e9f1a4b6c0 68645-130 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20110125 ANDA ANDA076001 Legacy Pharmaceutical Packaging, LLC FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68645-131_84918eb6-668e-4122-9e84-b6e9f1a4b6c0 68645-131 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20110125 ANDA ANDA076001 Legacy Pharmaceutical Packaging, LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68645-140_dc504ce4-4dce-46e5-9a4f-346340394e8b 68645-140 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20091026 ANDA ANDA075511 Legacy Pharmaceutical Packaging, LLC FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68645-141_dc504ce4-4dce-46e5-9a4f-346340394e8b 68645-141 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20091026 ANDA ANDA075511 Legacy Pharmaceutical Packaging, LLC FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68645-150_bb4ad992-88cc-4cb6-ab2f-e919cdcc6ee7 68645-150 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Legacy Pharmaceutical Packaging, LLC GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68645-151_bb4ad992-88cc-4cb6-ab2f-e919cdcc6ee7 68645-151 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 19950407 ANDA ANDA074305 Legacy Pharmaceutical Packaging, LLC GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68645-160_20fd1a9b-ba61-4258-a38e-8d4f570f5831 68645-160 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090911 ANDA ANDA074532 Legacy Pharmaceutical Packaging CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68645-161_20fd1a9b-ba61-4258-a38e-8d4f570f5831 68645-161 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090911 ANDA ANDA074532 Legacy Pharmaceutical Packaging CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68645-162_20fd1a9b-ba61-4258-a38e-8d4f570f5831 68645-162 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090911 ANDA ANDA074532 Legacy Pharmaceutical Packaging CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68645-163_20fd1a9b-ba61-4258-a38e-8d4f570f5831 68645-163 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20090911 ANDA ANDA074532 Legacy Pharmaceutical Packaging CAPTOPRIL 100 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68645-190_edf76f93-e7c2-41d9-a82f-a9c901c34e3f 68645-190 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Legacy Pharmaceutical Packaging, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 68645-191_edf76f93-e7c2-41d9-a82f-a9c901c34e3f 68645-191 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Legacy Pharmaceutical Packaging, LLC METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 68645-230_cd548efc-2b66-414b-b8b5-d9f60d122a86 68645-230 HUMAN PRESCRIPTION DRUG Belladonna Alkaloids with Phenobartbital Belladonna Alkaloids with Phenobartbital TABLET ORAL 20001201 UNAPPROVED DRUG OTHER Legacy Pharmaceutical Packaging ATROPINE SULFATE; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; PHENOBARBITAL .0194; .1037; .0065; 16.2 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68645-261_7ca18492-8ba1-4b24-97b3-fec147799031 68645-261 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20101001 ANDA ANDA077752 Legacy Pharmaceutical Packaging SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68645-262_7ca18492-8ba1-4b24-97b3-fec147799031 68645-262 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET ORAL 20101001 ANDA ANDA077752 Legacy Pharmaceutical Packaging SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68645-263_82a864ad-1652-405f-bbfa-b8ece0089165 68645-263 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Legacy Pharmaceutical Packaging SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68645-272_6ef589c7-9309-4f1c-8bf0-c1548636acc3 68645-272 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20101001 ANDA ANDA076059 Legacy Pharmaceutical Packaging LISINOPRIL 20 mg/1 N 20181231 68645-282_9e60b794-bc6a-40f2-87a1-7d4679535f4f 68645-282 HUMAN PRESCRIPTION DRUG Citalopram hydrobromide Citalopram hydrobromide TABLET ORAL 20101001 ANDA ANDA077038 Legacy Pharmaceutical Packaging CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-300_649ac19c-7e88-4681-8e7b-f2eca9a04820 68645-300 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120113 ANDA ANDA077095 Legacy Pharmaceutical Packaging, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68645-340_042c967b-29de-440b-ae48-abd0fde417aa 68645-340 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20020917 ANDA ANDA075907 Legacy Pharmaceutical Packaging HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68645-341_1ca96cd5-8cfc-4491-8722-9c4a3f45fedc 68645-341 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Legacy Pharmaceutical Packaging HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68645-350_eab3a56e-ddd9-44ff-a42c-c19a122ff8dd 68645-350 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Legacy Pharmaceutical Packaging, LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68645-351_eab3a56e-ddd9-44ff-a42c-c19a122ff8dd 68645-351 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Legacy Pharmaceutical Packaging, LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68645-405_63e83822-798e-46e0-87bf-45e9d2910184 68645-405 HUMAN PRESCRIPTION DRUG Irbesartan and Hydrochlorothiazide Irbesartan and Hydrochlorothiazide TABLET ORAL 20120330 ANDA ANDA077369 Legacy Pharmaceutical Packaging IRBESARTAN; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68645-407_69824774-368e-4810-9f4f-6bb1193e4986 68645-407 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Legacy Pharmaceutical Packaging, LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68645-409_69824774-368e-4810-9f4f-6bb1193e4986 68645-409 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Legacy Pharmaceutical Packaging, LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68645-411_69824774-368e-4810-9f4f-6bb1193e4986 68645-411 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20100406 ANDA ANDA076958 Legacy Pharmaceutical Packaging, LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68645-412_01088a07-95bb-4600-ae27-ef7297e0d136 68645-412 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA090150 Legacy Pharmaceutical Packaging LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68645-430_1191b0c2-049d-4401-8a63-e92d8ef3908c 68645-430 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET, FILM COATED ORAL 20120517 ANDA ANDA076999 Legacy Pharmaceutical Packaging CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68645-444_ecc615e5-f7f4-4ba1-8387-a16f3c0a0cfc 68645-444 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 20180630 ANDA ANDA077995 Legacy Pharmaceutical Packaging, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68645-445_ecc615e5-f7f4-4ba1-8387-a16f3c0a0cfc 68645-445 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20110101 20180731 ANDA ANDA077995 Legacy Pharmaceutical Packaging, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68645-446_b7bae393-9f44-49de-b858-2d5165e239de 68645-446 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20100801 20180831 ANDA ANDA090061 Legacy Pharmaceutical Packaging, LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68645-447_fd196d73-da47-4897-bc82-6735734632d8 68645-447 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 20180630 ANDA ANDA078604 Legacy Pharmaceutical Packaging, LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-448_fd196d73-da47-4897-bc82-6735734632d8 68645-448 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET ORAL 20120911 20180531 ANDA ANDA078604 Legacy Pharmaceutical Packaging, LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-449_82131ff0-de6d-4edd-bdd6-c13ef1cac931 68645-449 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 20180531 ANDA ANDA090478 Legacy Pharmaceutical Packaging, LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68645-450_82131ff0-de6d-4edd-bdd6-c13ef1cac931 68645-450 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20120402 20180831 ANDA ANDA090478 Legacy Pharmaceutical Packaging, LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68645-455_5203db2d-16a5-4c23-b7b8-15d37d05c81e 68645-455 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Legacy Pharmaceutical Packaging, LLC ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68645-456_5203db2d-16a5-4c23-b7b8-15d37d05c81e 68645-456 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Legacy Pharmaceutical Packaging, LLC ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68645-457_5203db2d-16a5-4c23-b7b8-15d37d05c81e 68645-457 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Legacy Pharmaceutical Packaging, LLC ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68645-458_e0493df2-b700-4845-9f49-c3a08eacc5bd 68645-458 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130101 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging, LLC ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68645-459_e0493df2-b700-4845-9f49-c3a08eacc5bd 68645-459 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging, LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68645-460_e0493df2-b700-4845-9f49-c3a08eacc5bd 68645-460 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging, LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68645-461_e0493df2-b700-4845-9f49-c3a08eacc5bd 68645-461 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging, LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68645-463_77a194e7-1f9a-431b-ae05-ab7b060eb672 68645-463 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Legacy Pharmaceutical Packaging, LLC DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68645-463_f21decdf-bd7a-4b2a-b331-8797276b88d9 68645-463 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 20181031 ANDA ANDA075580 Legacy Pharmaceutical Packaging, LLC DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68645-464_77a194e7-1f9a-431b-ae05-ab7b060eb672 68645-464 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Legacy Pharmaceutical Packaging, LLC DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68645-464_f21decdf-bd7a-4b2a-b331-8797276b88d9 68645-464 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 20180831 ANDA ANDA075580 Legacy Pharmaceutical Packaging, LLC DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68645-465_77a194e7-1f9a-431b-ae05-ab7b060eb672 68645-465 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Legacy Pharmaceutical Packaging, LLC DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68645-465_f21decdf-bd7a-4b2a-b331-8797276b88d9 68645-465 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 20180630 ANDA ANDA075580 Legacy Pharmaceutical Packaging, LLC DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68645-466_5f0df6bc-1032-47f9-a901-1a47abc3d153 68645-466 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, COATED ORAL 20120806 20190331 ANDA ANDA201582 Legacy Pharmaceutical Packaging, LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68645-467_2393be19-11a1-45ee-b6c2-2f170840eafd 68645-467 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 20180228 ANDA ANDA077534 Legacy Pharmaceutical Packaging, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-469_643cea63-a8c9-42e4-a88e-29b540d306f2 68645-469 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 20191031 ANDA ANDA077321 Legacy Pharmaceutical Packaging, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68645-470_18e5174f-b7f5-4034-bf03-f5829095c1e8 68645-470 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20070601 ANDA ANDA078103 Legacy Pharmaceutical Packaging, LLC SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68645-477_066f5522-2993-4ca8-bb04-e2c36fc2ca3e 68645-477 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Legacy Pharmaceutical Packaging, LLC METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68645-478_066f5522-2993-4ca8-bb04-e2c36fc2ca3e 68645-478 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Legacy Pharmaceutical Packaging, LLC METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68645-479_07feb536-cc0a-4e2a-9a88-2f0d5ec899db 68645-479 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 Legacy Pharmaceutical Packaging, LLC METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68645-480_3252fbcc-8b17-487e-9791-534000aff239 68645-480 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Legacy Pharmaceutical Packaging, LLC ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68645-480_d1fc4f6a-5436-4fb3-853c-1c4f532840bc 68645-480 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 20180430 ANDA ANDA090548 Legacy Pharmaceutical Packaging, LLC ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68645-481_3252fbcc-8b17-487e-9791-534000aff239 68645-481 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Legacy Pharmaceutical Packaging, LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68645-481_d1fc4f6a-5436-4fb3-853c-1c4f532840bc 68645-481 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 20180430 ANDA ANDA090548 Legacy Pharmaceutical Packaging, LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68645-482_e349cab0-eb40-4949-9198-9a5c24070801 68645-482 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging, LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68645-483_e349cab0-eb40-4949-9198-9a5c24070801 68645-483 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20111130 NDA AUTHORIZED GENERIC NDA020702 Legacy Pharmaceutical Packaging, LLC ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68645-487_c59a0e9b-beb7-468b-b89f-cb25871527f5 68645-487 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 20180430 ANDA ANDA077397 Legacy Pharmaceutical Packaging, LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-488_c59a0e9b-beb7-468b-b89f-cb25871527f5 68645-488 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 20180531 ANDA ANDA077397 Legacy Pharmaceutical Packaging, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-489_c59a0e9b-beb7-468b-b89f-cb25871527f5 68645-489 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 20180831 ANDA ANDA077397 Legacy Pharmaceutical Packaging, LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-491_f571cf1f-4855-4f77-a438-bf340d70160d 68645-491 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Legacy Pharmaceutical Packaging, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68645-492_79da5feb-bbb6-442a-ac54-620e756b8b28 68645-492 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 20180930 ANDA ANDA078281 Legacy Pharmaceutical Packaging, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 68645-492_f585b751-5e1b-451c-bfc1-661b3bf0ce01 68645-492 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA078281 Legacy Pharmaceutical Packaging, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 68645-493_e6ad5ff6-4c7f-46bb-a229-74bda1bec433 68645-493 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Legacy Pharmaceutical Packaging ATENOLOL 50 mg/mg Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68645-494_2249319b-bfcb-4130-af05-57ef2208d52d 68645-494 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Legacy Pharmaceutical Packaging, LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68645-495_3252fbcc-8b17-487e-9791-534000aff239 68645-495 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Legacy Pharmaceutical Packaging, LLC ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68645-496_eab3a56e-ddd9-44ff-a42c-c19a122ff8dd 68645-496 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA077614 Legacy Pharmaceutical Packaging, LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68645-497_26c8e02f-044e-41b9-ab0e-1c98c2c280a3 68645-497 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 20180831 ANDA ANDA078281 Legacy Pharmaceutical Packaging, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68645-499_c8635e1f-fe04-40ba-8e65-aa3572f0cdf4 68645-499 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 20180531 ANDA ANDA077397 Legacy Pharmaceutical Packaging, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-500_c8635e1f-fe04-40ba-8e65-aa3572f0cdf4 68645-500 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20071018 20180731 ANDA ANDA077397 Legacy Pharmaceutical Packaging, LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-510_1848acc8-4c17-41e8-af86-184b3e6634d6 68645-510 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19730112 ANDA ANDA083177 Legacy Pharmaceutical Packaging, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68645-511_1848acc8-4c17-41e8-af86-184b3e6634d6 68645-511 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 19800107 ANDA ANDA083177 Legacy Pharmaceutical Packaging, LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68645-512_93632b8e-0912-4712-8e74-67ef4f2dc78e 68645-512 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Legacy Pharmaceutical Packaging, LLC NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68645-513_93632b8e-0912-4712-8e74-67ef4f2dc78e 68645-513 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20051121 ANDA ANDA077127 Legacy Pharmaceutical Packaging, LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68645-514_3823cefb-48fa-42d2-bc60-b30ee64f9269 68645-514 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20160722 20181231 ANDA ANDA077534 Legacy Pharmaceutical Packaging, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-515_77afe783-e39f-42a2-a18c-62188984bba5 68645-515 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160701 ANDA ANDA077955 Legacy Pharmaceutical Packaging, LLC AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68645-516_77afe783-e39f-42a2-a18c-62188984bba5 68645-516 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160701 ANDA ANDA077955 Legacy Pharmaceutical Packaging, LLC AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68645-517_305e7cfe-50c1-45d6-91db-9fc02a1e397c 68645-517 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 Legacy Pharmaceutical Packaging, LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68645-518_305e7cfe-50c1-45d6-91db-9fc02a1e397c 68645-518 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 Legacy Pharmaceutical Packaging, LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68645-519_8d859353-73fd-450f-94d1-e7c41c8c7f2e 68645-519 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram TABLET, FILM COATED ORAL 20160616 ANDA ANDA078604 Legacy Pharmaceutical Packaging, LLC ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-520_8d859353-73fd-450f-94d1-e7c41c8c7f2e 68645-520 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram TABLET, FILM COATED ORAL 20160616 ANDA ANDA078604 Legacy Pharmaceutical Packaging, LLC ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-521_eb00fe8b-7872-4b21-9088-4a75b88106e3 68645-521 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Legacy Pharmaceutical Packaging, LLC SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68645-522_eb00fe8b-7872-4b21-9088-4a75b88106e3 68645-522 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Legacy Pharmaceutical Packaging, LLC SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68645-523_eb00fe8b-7872-4b21-9088-4a75b88106e3 68645-523 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Legacy Pharmaceutical Packaging, LLC SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 68645-524_af26c208-8b1a-4f88-9988-b151cbedd7d2 68645-524 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA078232 Legacy Pharmaceutical Packaging, LLC LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68645-525_af26c208-8b1a-4f88-9988-b151cbedd7d2 68645-525 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA078232 Legacy Pharmaceutical Packaging, LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68645-526_af26c208-8b1a-4f88-9988-b151cbedd7d2 68645-526 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA078232 Legacy Pharmaceutical Packaging, LLC LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68645-527_024a0fdf-575f-40a1-9c28-b173f0962c5c 68645-527 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20151202 ANDA ANDA078103 Legacy Pharmaceutical Packaging, LLC SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68645-528_70360e37-c7a1-4f21-8912-1f26a42f7143 68645-528 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 20181130 ANDA ANDA078605 Legacy Pharmaceutical Packaging, LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68645-529_99083120-969e-4178-916a-93cfc57dc81a 68645-529 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20150921 20181031 ANDA ANDA091625 Legacy Pharmaceutical Packaging, LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68645-530_99083120-969e-4178-916a-93cfc57dc81a 68645-530 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20150921 20190331 ANDA ANDA091625 Legacy Pharmaceutical Packaging, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68645-531_99083120-969e-4178-916a-93cfc57dc81a 68645-531 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20150921 20190531 ANDA ANDA091625 Legacy Pharmaceutical Packaging, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68645-532_8e24cabd-525a-4566-a840-b1721d523bae 68645-532 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170307 ANDA ANDA077321 Legacy Pharmaceutical Packaging, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68645-539_bc41a66a-e7d4-4740-9ccc-defcf776d753 68645-539 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Legacy Pharmaceutical Packaging, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 68645-541_8a3b903a-03da-4024-bd6f-0bd793b813a6 68645-541 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20150613 ANDA ANDA090061 Legacy Pharmaceutical Packaging, LLC FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68645-544_eb14bb89-1772-47b4-a649-343fbab6d916 68645-544 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Legacy Pharmaceutical Packaging, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 68645-545_eb14bb89-1772-47b4-a649-343fbab6d916 68645-545 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Legacy Pharmaceutical Packaging, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 68645-546_8fb69754-4743-4cba-82a8-41b76ed00712 68645-546 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20140716 ANDA ANDA090564 Legacy Pharmaceutical Packaging, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 68645-547_eb14bb89-1772-47b4-a649-343fbab6d916 68645-547 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Legacy Pharmaceutical Packaging, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 68645-548_8fb69754-4743-4cba-82a8-41b76ed00712 68645-548 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, FILM COATED ORAL 20140716 ANDA ANDA090564 Legacy Pharmaceutical Packaging, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 68645-549_bc41a66a-e7d4-4740-9ccc-defcf776d753 68645-549 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20141209 ANDA ANDA203686 Legacy Pharmaceutical Packaging, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 68645-550_d7e3eb71-215e-40b9-ad5a-a3fe78a00c21 68645-550 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Legacy Pharmaceutical Packaging, LLC LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 68645-551_d7e3eb71-215e-40b9-ad5a-a3fe78a00c21 68645-551 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Legacy Pharmaceutical Packaging, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 68645-552_d7e3eb71-215e-40b9-ad5a-a3fe78a00c21 68645-552 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Legacy Pharmaceutical Packaging, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 68645-553_d7e3eb71-215e-40b9-ad5a-a3fe78a00c21 68645-553 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Legacy Pharmaceutical Packaging, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 68645-554_d7e3eb71-215e-40b9-ad5a-a3fe78a00c21 68645-554 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Legacy Pharmaceutical Packaging, LLC LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 68645-555_d7e3eb71-215e-40b9-ad5a-a3fe78a00c21 68645-555 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20060113 ANDA ANDA077321 Legacy Pharmaceutical Packaging, LLC LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 68645-556_24b95943-1ffe-44ef-93b0-b77de1a9209d 68645-556 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20061004 ANDA ANDA077912 Legacy Pharmaceutical Packaging, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 68645-557_24b95943-1ffe-44ef-93b0-b77de1a9209d 68645-557 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 Legacy Pharmaceutical Packaging, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 68645-558_24b95943-1ffe-44ef-93b0-b77de1a9209d 68645-558 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20060410 ANDA ANDA077912 Legacy Pharmaceutical Packaging, LLC HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 68645-559_7b0432a8-c283-4ddc-98ec-ca835f51e4b3 68645-559 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Legacy Pharmaceutical Packaging, LLC CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68645-560_85adc833-5ed6-4dea-bde1-d17c0f5210d0 68645-560 HUMAN PRESCRIPTION DRUG Montelukast Montelukast TABLET, FILM COATED ORAL 20140910 ANDA ANDA202843 Legacy Pharmaceutical Packaging, LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68645-561_f1e602af-dee9-4c80-9d15-f6702caf8ec7 68645-561 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 Legacy Pharmaceutical Packaging, LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68645-562_f1e602af-dee9-4c80-9d15-f6702caf8ec7 68645-562 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 Legacy Pharmaceutical Packaging, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68645-563_f1e602af-dee9-4c80-9d15-f6702caf8ec7 68645-563 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 Legacy Pharmaceutical Packaging, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68647-102_36a1fca4-9c57-4cb8-b83a-ebf7f92deee1 68647-102 HUMAN OTC DRUG K-OK Kiddie Calmer Silicea , Aconite , Sucrose TABLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Feelgood Health SILICON DIOXIDE; ACONITUM NAPELLUS 6; 6 [hp_C]/1; [hp_C]/1 E 20171231 68647-103_80e4e2bc-6b1f-41c8-a1cc-a7a141c732d8 68647-103 HUMAN OTC DRUG iBaba Chamomilla , Mag phos, Sucrose GRANULE ORAL 20100802 UNAPPROVED HOMEOPATHIC Feelgood Health MATRICARIA RECUTITA; MAGNESIUM PHOSPHATE 6; 6 [hp_C]/100mg; [hp_C]/100mg E 20171231 68647-106_e024f096-2285-44bc-a0ba-fcc36297f7c3 68647-106 HUMAN OTC DRUG CroupEx Sprinkles Aconitum nap , Hepar sulph calc , Kali mur , Mag phos , Rumex crisp , Sucrose GRANULE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ACONITUM NAPELLUS; CALCIUM SULFIDE; POTASSIUM CHLORIDE; MAGNESIUM PHOSPHATE; RUMEX CRISPUS POLLEN 30; 6; 6; 6; 6 [hp_C]/40mg; [hp_C]/40mg; [hp_X]/40mg; [hp_X]/40mg; [hp_C]/40mg E 20171231 68647-112_6ed4bff3-77bd-4ea3-8003-9fe83c405e56 68647-112 HUMAN OTC DRUG Hang-Over Morning Mend Humulus , Lobelia inf , Nux vom , Lactose TABLET ORAL 20100715 UNAPPROVED HOMEOPATHIC Feelgood Health HOPS; LOBELIA; STRYCHNOS NUX-VOMICA SEED 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 68647-115_1b7ceedb-3942-4940-b097-b28b2915d785 68647-115 HUMAN OTC DRUG BladderWell Sarsaparilla, Ferrum phos, Apis mel, Equisetum arv, Cantharis TABLET ORAL 20100713 UNAPPROVED HOMEOPATHIC Feelgood Health SARSAPARILLA ROOT; FERRUM PHOSPHORICUM; APIS MELLIFERA; EQUISETUM ARVENSE TOP; LYTTA VESICATORIA 30; 6; 30; 30; 30 [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 68647-117_679a30f8-f46b-4362-9984-b9102f26a36f 68647-117 HUMAN OTC DRUG FluGo Ferrum phos, Nat mur, Belladonna, Alium cepa, Arsenicum iod TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health FERRUM PHOSPHORICUM; SODIUM CHLORIDE; ATROPA BELLADONNA ROOT; ONION; ARSENIC TRIIODIDE 6; 6; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 68647-118_d54fc24a-a270-4997-9df2-e737bc85461b 68647-118 HUMAN OTC DRUG RosaRex Carbo veg, Calc phos , Kali brom, Calc sil Violo tric , Lactose . TABLET ORAL 20100719 UNAPPROVED HOMEOPATHIC Feelgood Health ACTIVATED CHARCOAL; TRIBASIC CALCIUM PHOSPHATE; POTASSIUM BROMIDE; CALCIUM SILICATE; VIOLA TRICOLOR 30; 6; 30; 30; 6 [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 68647-120_ff68c632-e24e-4898-a801-8ccd440aede7 68647-120 HUMAN OTC DRUG BaniFlu Influenzinum , Bacillinum , Gelsemium , Lactose TABLET ORAL 20100719 UNAPPROVED HOMEOPATHIC Feelgood Health HAEMOPHILUS INFLUENZAE TYPE B; ESCHERICHIA COLI; GELSEMIUM SEMPERVIRENS ROOT 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 68647-122_8f39f7f4-8382-4be3-9f89-1d36e73c1354 68647-122 HUMAN OTC DRUG Easy Air Travel ACONITUM, ARG NIT, ARSENICUM ALB TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 E 20171231 68647-130_e16922bf-6b2b-4ba5-a301-f42c84e998b4 68647-130 HUMAN OTC DRUG Triple Complex Nerve Tonic Ferrum phos , Kali phos, Mag phos TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health FERRUM PHOSPHORICUM; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 68647-131_4a39a724-8a68-4fb8-99cc-3eebd8e0760c 68647-131 HUMAN OTC DRUG Triple Complex Digestion Tonic Kali phos, Nat phos , Calc phos, Lactose TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 68647-134_9854269d-ac34-4bce-83eb-5953c5f646c2 68647-134 HUMAN OTC DRUG Triple Complex Diabetonic Kali sulph , Nat sulphuricum , Calc phos , Lactose TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health POTASSIUM SULFATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 68647-160_de2842ca-f315-463d-b5f1-b634abea58e7 68647-160 HUMAN OTC DRUG CanTravel Mentha pip, Zingiber, Pulsatilla , Cocculus , Kali phos , Sucrose GRANULE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health PEPPERMINT; CARDAMOM; PULSATILLA PATENS; ANAMIRTA COCCULUS SEED; POTASSIUM PHOSPHATE, DIBASIC 3; 3; 6; 6; 6 [hp_X]/50mg; [hp_X]/50mg; [hp_C]/50mg; [hp_C]/50mg; [hp_C]/50mg E 20171231 68647-161_8c783a96-f56f-4ab4-835d-bbcba42395aa 68647-161 HUMAN OTC DRUG Eddy Ear Sprinkles Echinacea purp, Chamomilla , Calc sulph , Ferrum phos, Pulsatilla , Belladonna GRANULE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ECHINACEA PURPUREA; CHAMOMILE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; PULSATILLA VULGARIS; ATROPA BELLADONNA 3; 3; 6; 6; 12; 30 [hp_X]/33.3mg; [hp_X]/33.3mg; [hp_X]/33.3mg; [hp_X]/33.3mg; [hp_C]/33.3mg; [hp_C]/33.3mg E 20171231 68647-163_3231db0b-cd48-43e0-b8bf-058d788b6c7e 68647-163 HUMAN OTC DRUG KiddieVom Zingiber, Cocculus, Chamomilla , Arsenicum alb , Ipecac , Sucrose GRANULE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health CARDAMOM; JATEORHIZA CALUMBA ROOT; CHAMOMILE; ARSENIC TRIOXIDE; ASCLEPIAS CURASSAVICA 3; 3; 30; 6; 6 [hp_X]/40mg; [hp_C]/40mg; [hp_C]/40mg; [hp_C]/40mg; [hp_C]/40mg E 20171231 68647-165_4d3ab8fa-4961-4dd0-8361-e7c92e3bb5f6 68647-165 HUMAN OTC DRUG Oral Soothe Passiflora, Chamomilla, Calc fluor, Calc phos, Chamomilla GRANULE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health PASSIFLORA INCARNATA TOP; MATRICARIA RECUTITA; CALCIUM FLUORIDE; ANHYDROUS DIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA 3; 3; 6; 6; 6 [hp_X]/40mg; [hp_X]/40mg; [hp_X]/40mg; [hp_X]/40mg; [hp_C]/40mg E 20171231 68647-166_381e7a4c-732a-4da8-bce0-e2e5b545d376 68647-166 HUMAN OTC DRUG Acid Free-Flux Calc phos, Carbo veg, Nat phos , Mag carb, Silicea TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health TRIBASIC CALCIUM PHOSPHATE; ACTIVATED CHARCOAL; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; MAGNESIUM CARBONATE; SILICON DIOXIDE 6; 6; 6; 6; 6 [hp_X]/33.3mL; [hp_C]/33.3mL; [hp_X]/33.3mL; [hp_C]/33.3mL; [hp_X]/33.3mL E 20171231 68647-167_4e004023-51f7-460d-b121-6f5dc0281abf 68647-167 HUMAN OTC DRUG HayFever Fighter Arsen iod , Euphrasia , Allium cepa , Wyethia , Kali bich , Sambucus TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ARSENIC TRIIODIDE; EUPHRASIA STRICTA; ONION; WYETHIA HELENIOIDES ROOT; POTASSIUM DICHROMATE; AMERICAN ELDERBERRY 6; 6; 6; 6; 6; 6 [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_C]/33.3mL E 20171231 68647-168_160ecf24-1f35-4a71-a5ad-8d3c4b0cb880 68647-168 HUMAN OTC DRUG Gout-Gone Antimonium crud , Quercus , Rhododendron, Benzoic ac , Silicea , Nux vom , Ledum , Citricidal Extract TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ANTIMONY TRISULFIDE; CANDIDA PARAPSILOSIS; LEDUM PALUSTRE TWIG; 2-ETHYLHEXYL 4-PHENYLBENZOPHENONE-2'-CARBOXYLATE; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; LEDUM PALUSTRE TWIG 6; 12; 6; 6; 6; 6; 6 [hp_C]/28.5mL; [hp_C]/28.5mL; [hp_C]/28.5mL; [hp_C]/28.5mL; [hp_X]/28.5mL; [hp_C]/28.5mL; [hp_C]/28.5mL E 20171231 68647-169_e113e22d-085d-4cf2-a835-b71a12a3aeca 68647-169 HUMAN OTC DRUG Anal Itch Ease Fagopyrum, Croton , Aesculus, Sulphur , Kali sulph , Cina TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health BUCKWHEAT; CASTOR OIL; AESCULUS CARNEA FLOWER; SULFUR; POTASSIUM SULFATE; ARTEMISIA CINA FLOWER 12; 6; 12; 12; 6; 6 [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_C]/33.3mL; [hp_X]/33.3mL; [hp_C]/33.3mL E 20171231 68647-170_a76d953e-092b-47f0-acff-e12537fe34ca 68647-170 HUMAN OTC DRUG Leg Cramp Away Calc phos, Mag phos, Rhus tox , Nux vom , Citricidal extract TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health TRIBASIC CALCIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; STRYCHNOS NUX-VOMICA SEED 6; 6; 6; 12 [hp_X]/50mL; [hp_X]/50mL; [hp_C]/50mL; [hp_C]/50mL E 20171231 68647-171_effedad7-579e-45c7-9e6c-66c42d9bd2bb 68647-171 HUMAN OTC DRUG Headache Soothe China , Nux vom, Chamomilla, Kali phos , Mag phos TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health AILANTHUS ALTISSIMA FLOWERING TWIG; STRYCHNOS NUX-VOMICA SEED; CHAMOMILE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12; 12; 12; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_X]/40mL; [hp_X]/40mL E 20171231 68647-172_eafeb411-a014-4dd0-98cd-866626884e53 68647-172 HUMAN OTC DRUG ORAL ASSIST ORAL ASSIST TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health SALICYLIC ACID; SILICON DIOXIDE; BELLADONNA LEAF; MERCURIUS SOLUBILIS; FERRUM PHOSPHORICUM; CALCIUM SULFIDE 6; 6; 30; 12; 6; 12 [hp_C]/33.33mg; [hp_X]/33.33mg; [hp_C]/33.33mg; [hp_C]/33.33mg; [hp_X]/33.33mg; [hp_C]/33.33mg E 20171231 68647-173_27e95fa0-5ddb-4f31-ad34-4125256dfd0b 68647-173 HUMAN OTC DRUG Conjunct-a-Clear Euphrasia , Pulsatilla , Psorinum , Merc sol , Graphites, Citricidal Extract TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health EUPHRASIA STRICTA; PULSATILLA PATENS; SCABIES LESION LYSATE (HUMAN); MERCURIUS SOLUBILIS; GRAPHITE 6; 12; 12; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 68647-174_d7bd3d3e-1aa2-4ef5-a6e0-8c151e401220 68647-174 HUMAN OTC DRUG Conjunct-a-Clear Wash Euphrasia , Calendula, Agrimony, Arg nit TINCTURE OPHTHALMIC 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health EUPHRASIA STRICTA; CALENDULA OFFICINALIS FLOWER; AGRIMONIA EUPATORIA; SILVER NITRATE 6; 3; 3; 5 [hp_C]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL E 20171231 68647-175_952d9161-6d01-4e65-a1c8-13f08501faf8 68647-175 HUMAN OTC DRUG Tic Tamer TicTam TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health HYOSCYAMUS; ZINC METHIONINE SULFATE; ARTEMISIA CINA FLOWER; CHAMOMILE 30; 30; 30; 12 [hp_C]/50mg; [hp_C]/50mg; [hp_C]/50mg; [hp_C]/50mg E 20171231 68647-176_892023f3-579b-46ab-82fd-7254aa842084 68647-176 HUMAN OTC DRUG Vagi Soothe Kreosotum, Merc sol, Lycopodium , Calc carb, Sepia TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health LARREA TRIDENTATA TOP; MERCURIUS SOLUBILIS; LYCOPODIUM CLAVATUM SPORE; CALCIUM CARBONATE; ACANTHOSEPION CUTTLEFISH 12; 30; 12; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 68647-177_24c97740-6018-41fe-b1b9-5e2c949dbfe7 68647-177 HUMAN OTC DRUG Scab Ease Itch Relief Psorinum , Staphisagria , Viola tri TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health SCABIES LESION LYSATE (HUMAN); DELPHINIUM STAPHISAGRIA SEED; VIOLA TRICOLOR 12; 12; 12 [hp_C]/66.6mL; [hp_C]/66.6mL; [hp_C]/66.6mL E 20171231 68647-178_2102cd03-fdba-4eb3-9dcc-b65ff595c0e1 68647-178 HUMAN OTC DRUG AngerSoothe AngerSoothe TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health STRYCHNOS NUX-VOMICA SEED; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; MINT 6; 5; 6; 1 [hp_C]/50mg; [hp_C]/50mg; [hp_C]/50mg; [hp_X]/10mg E 20171231 68647-179_53e902b8-d0a3-4f78-908b-a0b4707d8575 68647-179 HUMAN OTC DRUG SAD Soother Calc carb, Alumina , Aurum met, Nat mur , Kali phos TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health OYSTER SHELL CALCIUM CARBONATE, CRUDE; ALUMINUM OXIDE; GOLD; SODIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC 6; 30; 30; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_X]/40mL; [hp_X]/40mL E 20171231 68647-180_3cd890ab-63fe-4518-858a-972c9e8fbf68 68647-180 HUMAN OTC DRUG Mucus Clear Kali mur , Kali sulph , Kali bich , Citricidal Extract TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health POTASSIUM CHLORIDE; POTASSIUM SULFATE; POTASSIUM DICHROMATE 6; 6; 6 [hp_X]/50mL; [hp_X]/50mL; [hp_C]/50mL E 20171231 68647-181_475cf82e-8ada-4bce-bd69-a7b45fe5f8ea 68647-181 HUMAN OTC DRUG Sweat-Less Nat mur , Lupulus, Castoreum , Argentum nit , Syphilinum TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health SODIUM CHLORIDE; HOPS; BOWFIN; SILVER NITRATE; CALIFORNIA SHEEPHEAD 6; 30; 30; 6; 30 [hp_X]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 68647-182_4558f8f1-501a-4058-b09e-97edd77a4fd0 68647-182 HUMAN OTC DRUG Inflammago Arnica , Dulcamara, Bryonia , Berberis , Rhus tox TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ARNICA ANGUSTIFOLIA FLOWER; SOLANUM DULCAMARA FLOWER; BRYONIA ALBA ROOT; BERBERIS VULGARIS FRUIT; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 30 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 68647-192_811fee6a-17fa-484a-b4c9-0c5f96bf3560 68647-192 HUMAN OTC DRUG Nutra RX Arnica Pain and Healing Bellis, Symphytum, Arnica , Mag phos, Chamomilla TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health BELLIS PERENNIS; COMFREY ROOT; ARNICA MONTANA; MAGNESIUM PHOSPHATE; MATRICARIA RECUTITA 3; 3; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 68647-193_7489efee-9123-4411-a252-99edf07f8ebd 68647-193 HUMAN OTC DRUG NutraRX Inflam Dr. Arnica, Dulcamara , Bryonia , Berberis , Rhus tox TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ARNICA MONTANA; SOLANUM DULCAMARA TOP; BRYONIA ALBA ROOT; BERBERIS VULGARIS ROOT BARK; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 30 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 68647-194_82f591bb-ef54-456f-bfcf-cec88942b079 68647-194 HUMAN OTC DRUG NutraRX Digest-Able Kali phos, Nat phos, Calc phos TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC ANHYDROUS; TRIBASIC CALCIUM PHOSPHATE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 68647-195_434f6be2-60d1-4a6f-bd8d-4e200546f70f 68647-195 HUMAN OTC DRUG StyeGone Pulsatilla , Staphagria , Psorinum , Graphites TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health PULSATILLA PATENS; DELPHINIUM STAPHISAGRIA SEED; SCABIES LESION LYSATE (HUMAN); GRAPHITE 6; 6; 6; 6 [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL E 20171231 68647-196_e8601657-633a-4e7e-9e82-2e6c347c2443 68647-196 HUMAN OTC DRUG QueaseX Anti Nausea Drops Nux vom, Pulsatilla , Ipecac, Chamomilla, Zingiber TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health STRYCHNOS NUX-VOMICA SEED; PULSATILLA PATENS; IPECAC; CHAMOMILE; CARDAMOM 6; 6; 6; 12; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 68647-197_62305208-119e-4a40-a465-be6eadfe1181 68647-197 HUMAN OTC DRUG FibroFree Complex Bryonia, Calcarea carb, Ranunculus bulb, Rhus tox, Staphagria TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; DELPHINIUM STAPHISAGRIA SEED 6; 6; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 68647-198_ff615db3-bb22-481b-ab85-1681e9f25b99 68647-198 HUMAN OTC DRUG Digesto-K Melissa , Mentha pip, Mag phos , Nat sulphuricum, Phos GRANULE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health LEMON BALM OIL; PEPPERMINT; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM SULFATE; PHOSPHORUS 3; 3; 6; 6; 6 [hp_X]/40mg; [hp_X]/40mg; [hp_X]/40mg; [hp_X]/40mg; [hp_C]/40mg E 20171231 68647-200_04a0573b-8da5-4a17-9f29-ec5dff8ef299 68647-200 HUMAN OTC DRUG StretchEasy Formula Calc fluor , Calc phos, Nat mur TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health CALCIUM FLUORIDE; ANHYDROUS DIBASIC CALCIUM PHOSPHATE; SODIUM CHLORIDE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 68647-201_7893454f-f5f6-4e32-85fd-1a286f64b342 68647-201 HUMAN OTC DRUG Vagi-Clear Sepia, Kreosotum, Kali phos , Pulsatilla, Nitricum ac TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health SEPIA OFFICINALIS JUICE; LARREA TRIDENTATA TOP; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA PATENS; NITRIC ACID 6; 6; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_X]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 68647-202_38b0b2d2-5bf0-43ad-a099-5ff39c845b86 68647-202 HUMAN OTC DRUG Stomach Flu Fighter Arsenicum alb, Colocynthis , Pulsatilla , Mag phos TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health ARSENIC TRIOXIDE; CITRULLUS COLOCYNTHIS FRUIT PULP; PULSATILLA PATENS; MAGNESIUM PHOSPHATE 6; 6; 6; 6 [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL; [hp_C]/50mL E 20171231 68647-203_9323eddd-34ab-453c-abb6-ab17cbb148aa 68647-203 HUMAN OTC DRUG Boil-Rx Hepar sulph, Silica mar, Sulfur iod, Echinacea , Calc sil, Citricidal Extract TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health CALCIUM SULFIDE; SILICON DIOXIDE; SULFUR IODIDE; ECHINACEA; CALCIUM SILICATE 6; 6; 6; 6; 6 [hp_C]/40mL; [hp_X]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 68647-204_392b2086-fe0d-43c6-a692-8281d94db32b 68647-204 HUMAN OTC DRUG Kidney Stone Clear Berberis vulg, Calc carb, Cantharis, Lycopodium, Belladonna TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health BERBERIS VULGARIS FRUIT; CALCIUM CARBONATE; LYTTA VESICATORIA; LYCOPODIUM CLAVATUM SPORE; ATROPA BELLADONNA 6; 6; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 68647-205_ddea6f89-5da8-4f02-8edd-3a5944be2fed 68647-205 HUMAN OTC DRUG Hive Away Urtica ur , Apis mel, Chamomilla , Ammon carb, Rhus tox TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health URTICA URENS; APIS MELLIFERA; CHAMOMILE; AMMONIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 68647-206_e2311abe-7c79-44ee-b73e-1b4746c87a1d 68647-206 HUMAN OTC DRUG Sinus Soothe Kali bich, Pulsatilla, Hepar sulph , Thuja occ , Spigelia anth TINCTURE ORAL 20100101 UNAPPROVED HOMEOPATHIC Feelgood Health POTASSIUM DICHROMATE; PULSATILLA PATENS; CALCIUM SULFIDE; CEDAR LEAF OIL; SPIGELIA 6; 6; 6; 12; 6 [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL; [hp_C]/40mL E 20171231 68647-207_cdf25d0e-be83-4a9e-8d2b-27a585174fc6 68647-207 HUMAN OTC DRUG Triple Complex Calm Tonic Ferrum phos , Kali phos, Mag phos TABLET ORAL 20110620 UNAPPROVED HOMEOPATHIC Feelgood Health FERRUM PHOSPHORICUM; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 68654-575_4a118beb-d5e9-4aee-9f0a-b5cdc6190c8d 68654-575 HUMAN OTC DRUG Insti-Foam Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL OTC MONOGRAPH NOT FINAL part333 Share Corporation BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 68654-585_2e007cec-4db3-4991-99df-9bf2df750dcb 68654-585 HUMAN OTC DRUG Foamahol ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333 Share Corporation ALCOHOL .7 mL/mL N 20181231 68654-773_1a3bf123-1926-4474-aa7e-24c21fa6776c 68654-773 HUMAN OTC DRUG Handful Sanitizer ALCOHOL AEROSOL, FOAM TOPICAL 20090831 OTC MONOGRAPH NOT FINAL part333 Share Corporation ALCOHOL 620 mg/g E 20171231 68654-774_3831d779-925e-408b-b85b-88c01f4ba143 68654-774 HUMAN OTC DRUG Handful Sanitizer ALCOHOL AEROSOL, FOAM TOPICAL 20160722 OTC MONOGRAPH NOT FINAL part333E Share Corporation ALCOHOL 620 mg/g E 20171231 68654-855_9aa0d6c7-4a77-4c07-b388-a2a7346011a2 68654-855 HUMAN OTC DRUG Foamahol ALCOHOL LIQUID TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part333E Share Corporation ALCOHOL .62 mL/mL E 20171231 68663-876_212754ab-b987-41af-ba28-812a618b72cc 68663-876 HUMAN OTC DRUG Medicascrub High Foaming Antiseptic Hand Cleaner CHLOROXYLENOL SOAP TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333E First Medical Infection Control Associates, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 68669-522_d3344ae3-17c8-47d4-988b-e872240bffcf 68669-522 HUMAN PRESCRIPTION DRUG Betimol timolol SOLUTION OPHTHALMIC 20001001 NDA NDA020439 Vistakon Pharmaceuticals LLC TIMOLOL 2.5 mg/mL E 20171231 68669-525_d3344ae3-17c8-47d4-988b-e872240bffcf 68669-525 HUMAN PRESCRIPTION DRUG Betimol timolol SOLUTION OPHTHALMIC 20001001 NDA NDA020439 Vistakon Pharmaceuticals LLC TIMOLOL 5 mg/mL E 20171231 68678-011_27fde2b6-2a0c-3655-e054-00144ff88e88 68678-011 HUMAN OTC DRUG Cold Therapy Menthol GEL TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 AHC VENTURES CORP DBA CRYODERM MENTHOL 10 g/100mL E 20171231 68678-011_27fde2b6-2a1d-3655-e054-00144ff88e88 68678-011 HUMAN OTC DRUG Cold Therapy Menthol GEL TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 AHC VENTURES CORP DBA CRYODERM MENTHOL 10 g/100mL E 20171231 68678-011_27fde2b6-2a2d-3655-e054-00144ff88e88 68678-011 HUMAN OTC DRUG Cold Therapy Menthol SPRAY TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 AHC Ventures Corp DBA Cryoderm MENTHOL 10 g/100mL E 20171231 68678-039_27fde2b6-2a4d-3655-e054-00144ff88e88 68678-039 HUMAN OTC DRUG Pain Relieving Menthol, Camphor, Capsaicin LOTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 AHC VENTURES CORP DBA CRY MENTHOL; CAMPHOR (SYNTHETIC); CAPSAICIN 3.85; 3.85; .0355 g/100mL; g/100mL; g/100mL E 20171231 68678-040_27fde2b6-2a5d-3655-e054-00144ff88e88 68678-040 HUMAN OTC DRUG Pain Relieving Roll-On Menthol, Camphor, Capsaicin LOTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 AHC VENTURES CORP DBA CRY MENTHOL; CAMPHOR (SYNTHETIC); CAPSAICIN 3.85; 3.85; .0355 g/100mL; g/100mL; g/100mL E 20171231 68678-063_2812572d-00a8-0d61-e054-00144ff8d46c 68678-063 HUMAN OTC DRUG NovoPain Menthol, Camphor SPRAY TOPICAL 20151222 OTC MONOGRAPH NOT FINAL part348 AHC VENTURES CORP MENTHOL; CAMPHOR (SYNTHETIC) 4; .2 g/100mL; g/100mL E 20171231 68678-065_d2185c5f-4fa7-4c92-b545-973cefe9529a 68678-065 HUMAN OTC DRUG PROTEC PAIN RELIEF COLD THERAPY MENTHOL SPRAY TOPICAL 20160224 OTC MONOGRAPH NOT FINAL part348 AHC VENTURES MENTHOL 8 g/100mL E 20171231 68678-067_0d617965-6c3a-431f-b4f9-43df13744f95 68678-067 HUMAN OTC DRUG PROTEC ROLL-ON MENTHOL GEL TOPICAL 20160219 OTC MONOGRAPH NOT FINAL part348 ACH VENTURES CORP MENTHOL 8 g/100mL E 20171231 68682-001_e556c1e8-8bde-493b-92c6-4e750ae7a0e0 68682-001 HUMAN PRESCRIPTION DRUG Sodium Phenylacetate and Sodium Benzoate sodium phenylacetate and sodium benzoate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170315 NDA AUTHORIZED GENERIC NDA020645 Oceanside Pharmaceuticals SODIUM PHENYLACETATE; SODIUM BENZOATE 100; 100 mg/mL; mg/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 68682-002_dfb76211-4433-44cb-ac7a-aba9ba49c369 68682-002 HUMAN PRESCRIPTION DRUG bexarotene bexarotene GEL TOPICAL 20000628 NDA AUTHORIZED GENERIC NDA021056 Oceanside Pharmaceuticals BEXAROTENE 1 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 68682-003_8f5964b7-0df5-4f2a-b6db-4a055c64d902 68682-003 HUMAN PRESCRIPTION DRUG bexarotene bexarotene CAPSULE, LIQUID FILLED ORAL 20151217 NDA AUTHORIZED GENERIC NDA021055 Oceanside Pharmaceuticals BEXAROTENE 75 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 68682-006_27ea2e91-604f-4947-9362-0ed7492bc1df 68682-006 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem hydrochloride TABLET ORAL 20101225 NDA AUTHORIZED GENERIC NDA018602 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-007_27ea2e91-604f-4947-9362-0ed7492bc1df 68682-007 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET ORAL 20101225 NDA AUTHORIZED GENERIC NDA018602 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-008_27ea2e91-604f-4947-9362-0ed7492bc1df 68682-008 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET ORAL 20101225 NDA AUTHORIZED GENERIC NDA018602 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-009_27ea2e91-604f-4947-9362-0ed7492bc1df 68682-009 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET ORAL 20101225 NDA AUTHORIZED GENERIC NDA018602 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-010_2f284233-de0d-4bbb-a9fc-4f9fe4149391 68682-010 HUMAN PRESCRIPTION DRUG Sodium sulfacetamide Sodium sulfacetamide LOTION TOPICAL 20151218 NDA AUTHORIZED GENERIC NDA019931 Oceanside Pharmaceuticals SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 68682-011_e3a435a1-2edd-4bc8-88ca-9c58203f3897 68682-011 HUMAN PRESCRIPTION DRUG ethacrynic acid ethacrynic acid TABLET ORAL 19670110 NDA AUTHORIZED GENERIC NDA016092 Oceanside Pharmaceuticals ETHACRYNIC ACID 25 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68682-012_a267993a-39d4-4524-b3d6-c3a4dd3f4cd2 68682-012 HUMAN PRESCRIPTION DRUG ethacrynic sodium ethacrynic sodium POWDER, FOR SOLUTION INTRAVENOUS 19670110 NDA AUTHORIZED GENERIC NDA016093 Oceanside Pharmaceuticals ETHACRYNATE SODIUM 50 mg/50mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68682-012_e3a435a1-2edd-4bc8-88ca-9c58203f3897 68682-012 HUMAN PRESCRIPTION DRUG ethacrynic sodium ethacrynic sodium POWDER, FOR SOLUTION INTRAVENOUS 19670110 NDA AUTHORIZED GENERIC NDA016093 Oceanside Pharmaceuticals ETHACRYNATE SODIUM 50 mg/50mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68682-017_ad4180ad-6bf3-4650-9d8c-6f131ed783d4 68682-017 HUMAN PRESCRIPTION DRUG Metformin hydrochloride metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060801 NDA AUTHORIZED GENERIC NDA021748 Oceanside Pharmaceuticals METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68682-018_ad4180ad-6bf3-4650-9d8c-6f131ed783d4 68682-018 HUMAN PRESCRIPTION DRUG Metformin hydrochloride metformin hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060801 NDA AUTHORIZED GENERIC NDA021748 Oceanside Pharmaceuticals METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68682-019_1bd850c4-a638-4143-b6be-0c50521a0449 68682-019 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin POWDER, FOR SOLUTION RESPIRATORY (INHALATION) 20170414 NDA NDA018859 Oceanside Pharmaceuticals RIBAVIRIN 6 g/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 68682-065_12b39571-f883-4a2a-a909-aef528d77d0a 68682-065 HUMAN PRESCRIPTION DRUG Methoxsalen Methoxsalen CAPSULE, LIQUID FILLED ORAL 20140715 NDA AUTHORIZED GENERIC NDA019600 Oceanside Pharmaceuticals METHOXSALEN 10 mg/1 Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient] N 20181231 68682-101_9166af47-0302-4a90-a4e2-e6793720b54f 68682-101 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, EXTENDED RELEASE ORAL 20140822 ANDA ANDA075028 Oceanside Pharmaceuticals PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 68682-102_d5dfcfc0-947a-406b-9d44-463a89665649 68682-102 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate omepraziole, sodium bicarbonate CAPSULE ORAL 20060227 NDA AUTHORIZED GENERIC NDA021849 Oceanside Pharmaceuticals OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68682-103_455b696e-770a-4875-9b28-83d74d2afc70 68682-103 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000228 ANDA ANDA075492 Oceanside Pharmaceuticals DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68682-104_d5dfcfc0-947a-406b-9d44-463a89665649 68682-104 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate omeprazole, sodium bicarbonate CAPSULE ORAL 20060227 NDA AUTHORIZED GENERIC NDA021849 Oceanside Pharmaceuticals OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68682-105_b0ec0231-1be5-4b50-a2e4-62442a02b821 68682-105 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20121018 ANDA ANDA075269 Oceanside Pharmaceuticals NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68682-106_8370b567-53c6-495b-95bb-45d7f45e3e79 68682-106 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20001204 ANDA ANDA075269 Oceanside Pharmaceuticals NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68682-107_7c46a66e-ef14-4894-a917-b215ebf3fe0d 68682-107 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20020816 ANDA ANDA076070 Oceanside Pharmaceuticals NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68682-108_f95cf84c-6e4e-412d-86a1-4e3e57965521 68682-108 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000927 ANDA ANDA075289 Oceanside Pharmaceuticals NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68682-109_f95cf84c-6e4e-412d-86a1-4e3e57965521 68682-109 HUMAN PRESCRIPTION DRUG nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000927 ANDA ANDA075289 Oceanside Pharmaceuticals NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68682-146_2b463280-4bd8-4400-9ab4-005d44b9e3f6 68682-146 HUMAN PRESCRIPTION DRUG Enalapril Maleate and Hydrochlorothiazide Enalapril Maleate and Hydrochlorothiazide TABLET ORAL 19861031 20180831 NDA AUTHORIZED GENERIC NDA019221 Oceanside Pharmaceuticals ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68682-190_3e83cbdd-b9dd-4d10-8a81-062bd15de862 68682-190 HUMAN PRESCRIPTION DRUG Clindamycin phosphate and benzoyl peroxide Clindamycin phosphate and benzoyl peroxide GEL TOPICAL 20170328 NDA NDA050756 Oceanside Pharmaceuticals CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE 10; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68682-200_32765836-72d3-4eb4-9f96-589f9518d3be 68682-200 HUMAN PRESCRIPTION DRUG Carbidopa Carbidopa Tablets TABLET ORAL 20140404 NDA AUTHORIZED GENERIC NDA017830 Oceanside Pharmaceuticals CARBIDOPA 25 mg/1 N 20181231 68682-270_801f92dc-6c01-4f5a-a92f-72da0e46a01e 68682-270 HUMAN PRESCRIPTION DRUG HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE CREAM TOPICAL 20130703 NDA AUTHORIZED GENERIC NDA018514 Oceanside Pharmaceuticals HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68682-271_7c3f8417-7861-41e3-876f-9b82aff7d1a0 68682-271 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate hydrocortisone butyrate OINTMENT TOPICAL 20090901 NDA NDA018652 Oceanside Pharmaceuticals HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68682-273_13c341c1-49b7-45d8-b1f8-71ad04bbe357 68682-273 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate hydrocortisone butyrate SOLUTION TOPICAL 19870225 NDA AUTHORIZED GENERIC NDA019116 Oceanside Pharmaceuticals HYDROCORTISONE BUTYRATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68682-301_17aa51e7-35ca-48a8-9510-91e508246ef5 68682-301 HUMAN PRESCRIPTION DRUG pyridostigmine bromide pyridostigmine bromide TABLET, EXTENDED RELEASE ORAL 19590112 NDA AUTHORIZED GENERIC NDA011665 Oceanside Pharmaceuticals PYRIDOSTIGMINE BROMIDE 180 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68682-302_314c12ad-8c66-432c-b8e9-72085e6a5ff4 68682-302 HUMAN PRESCRIPTION DRUG Pyridostigmine Bromide Pyridostigmine Bromide TABLET ORAL 20071030 NDA AUTHORIZED GENERIC NDA009829 Oceanside Pharmaceuticals PYRIDOSTIGMINE BROMIDE 60 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 68682-306_d2213ffd-18f6-45f5-9af7-690a977562c4 68682-306 HUMAN PRESCRIPTION DRUG Butalbital and Acetaminophen Butalbital and Acetaminophen tablets TABLET ORAL 20170619 ANDA ANDA090956 Oceanside Pharmaceuticals BUTALBITAL; ACETAMINOPHEN 50; 300 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] N 20181231 68682-357_cacb50ee-930e-414a-a095-7c33e2d09186 68682-357 HUMAN PRESCRIPTION DRUG Dihydroergotamine Mesylate dihydroergotamine mesylate SPRAY NASAL 20130318 NDA AUTHORIZED GENERIC NDA020148 Oceanside Pharmaceuticals DIHYDROERGOTAMINE MESYLATE 4 mg/mL Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient] N 20191231 68682-367_99f0499a-cf84-47f0-af5d-0b56fc0bb717 68682-367 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-368_99f0499a-cf84-47f0-af5d-0b56fc0bb717 68682-368 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-369_99f0499a-cf84-47f0-af5d-0b56fc0bb717 68682-369 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-370_99f0499a-cf84-47f0-af5d-0b56fc0bb717 68682-370 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-371_99f0499a-cf84-47f0-af5d-0b56fc0bb717 68682-371 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-372_99f0499a-cf84-47f0-af5d-0b56fc0bb717 68682-372 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140820 NDA AUTHORIZED GENERIC NDA020401 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-384_2deb3c7d-5da6-43fb-9032-2bcad50ebda5 68682-384 HUMAN PRESCRIPTION DRUG Hydrocortisone Butyrate HYDROCORTISONE BUTYRATE CREAM TOPICAL 20130703 NDA AUTHORIZED GENERIC NDA020769 Oceanside Pharmaceuticals HYDROCORTISONE BUTYRATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68682-409_3fcc6460-5173-40f5-973c-8709eeb0737e 68682-409 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20090923 NDA AUTHORIZED GENERIC NDA012750 Oceanside Pharmaceuticals CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] N 20181231 68682-421_e96c0ef8-f464-41de-a468-d4b3169bdbd6 68682-421 HUMAN PRESCRIPTION DRUG tetrabenazine tetrabenazine TABLET ORAL 20150720 NDA AUTHORIZED GENERIC NDA021894 Oceanside Pharmaceuticals TETRABENAZINE 12.5 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20191231 68682-422_e96c0ef8-f464-41de-a468-d4b3169bdbd6 68682-422 HUMAN PRESCRIPTION DRUG tetrabenazine tetrabenazine TABLET ORAL 20150720 NDA AUTHORIZED GENERIC NDA021894 Oceanside Pharmaceuticals TETRABENAZINE 25 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20191231 68682-455_c2d9eedd-7f9a-4699-bffd-31a360c1d77f 68682-455 HUMAN PRESCRIPTION DRUG Metronidazole metronidazole GEL VAGINAL 20150401 NDA AUTHORIZED GENERIC NDA020208 Oceanside Pharmaceuticals METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68682-513_2781ea5e-d639-4752-951b-c2b0a1d0a059 68682-513 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20130314 NDA AUTHORIZED GENERIC NDA020475 Oceanside Pharmaceuticals TRETINOIN 1 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 68682-514_2781ea5e-d639-4752-951b-c2b0a1d0a059 68682-514 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20130314 NDA AUTHORIZED GENERIC NDA020475 Oceanside Pharmaceuticals TRETINOIN .4 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 68682-515_2781ea5e-d639-4752-951b-c2b0a1d0a059 68682-515 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20130314 NDA AUTHORIZED GENERIC NDA020475 Oceanside Pharmaceuticals TRETINOIN .8 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 68682-519_ab5a4a1c-90f1-40f3-aab4-6f299a885c52 68682-519 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET, FILM COATED ORAL 20160726 NDA AUTHORIZED GENERIC NDA050475 Oceanside Pharmaceuticals GRISEOFULVIN 125 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 68682-520_ab5a4a1c-90f1-40f3-aab4-6f299a885c52 68682-520 HUMAN PRESCRIPTION DRUG Griseofulvin Griseofulvin TABLET, FILM COATED ORAL 20160726 NDA AUTHORIZED GENERIC NDA050475 Oceanside Pharmaceuticals GRISEOFULVIN 250 mg/1 Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 68682-521_0b6ff099-9c5a-416f-a012-515ef5f7c4bd 68682-521 HUMAN PRESCRIPTION DRUG Diltiazem HCl CD Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20010411 NDA AUTHORIZED GENERIC NDA020062 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 68682-638_2137f45d-4715-4ae4-a805-ccf0c480d399 68682-638 HUMAN PRESCRIPTION DRUG Tretinoin TRETINOIN CREAM TOPICAL 20110201 ANDA ANDA076498 Oceanside Pharmaceuticals TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 68682-650_b1b2848b-b265-4f6f-9141-bf106dec0726 68682-650 HUMAN PRESCRIPTION DRUG Diazepam Diazepam GEL RECTAL 19970729 NDA AUTHORIZED GENERIC NDA020648 Oceanside Pharmaceuticals DIAZEPAM 2.5 mg/.5mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68682-652_b1b2848b-b265-4f6f-9141-bf106dec0726 68682-652 HUMAN PRESCRIPTION DRUG Diazepam diazepam GEL RECTAL 19970729 NDA AUTHORIZED GENERIC NDA020648 Oceanside Pharmaceuticals DIAZEPAM 10 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68682-655_b1b2848b-b265-4f6f-9141-bf106dec0726 68682-655 HUMAN PRESCRIPTION DRUG Diazepam Diazepam GEL RECTAL 19970729 NDA AUTHORIZED GENERIC NDA020648 Oceanside Pharmaceuticals DIAZEPAM 20 mg/4mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68682-705_4ec78aca-d95e-4124-b42c-3f530eda9617 68682-705 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Tablets TABLET, EXTENDED RELEASE ORAL 20140206 NDA AUTHORIZED GENERIC NDA021392 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-706_4ec78aca-d95e-4124-b42c-3f530eda9617 68682-706 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Tablets TABLET, EXTENDED RELEASE ORAL 20140206 NDA AUTHORIZED GENERIC NDA021392 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-707_4ec78aca-d95e-4124-b42c-3f530eda9617 68682-707 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Tablets TABLET, EXTENDED RELEASE ORAL 20140206 NDA AUTHORIZED GENERIC NDA021392 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-708_4ec78aca-d95e-4124-b42c-3f530eda9617 68682-708 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Tablets TABLET, EXTENDED RELEASE ORAL 20140206 NDA AUTHORIZED GENERIC NDA021392 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-709_4ec78aca-d95e-4124-b42c-3f530eda9617 68682-709 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Tablets TABLET, EXTENDED RELEASE ORAL 20140206 NDA AUTHORIZED GENERIC NDA021392 Oceanside Pharmaceuticals DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-710_8b1bd522-423a-4f24-8aa7-d90c289ee35e 68682-710 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 19880726 NDA AUTHORIZED GENERIC NDA018998 OCEANSIDE PHARMACEUTICALS ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 68682-711_8b1bd522-423a-4f24-8aa7-d90c289ee35e 68682-711 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 19851224 NDA AUTHORIZED GENERIC NDA018998 OCEANSIDE PHARMACEUTICALS ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 68682-712_8b1bd522-423a-4f24-8aa7-d90c289ee35e 68682-712 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 19851224 NDA AUTHORIZED GENERIC NDA018998 OCEANSIDE PHARMACEUTICALS ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 68682-713_8b1bd522-423a-4f24-8aa7-d90c289ee35e 68682-713 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 19851224 NDA AUTHORIZED GENERIC NDA018998 OCEANSIDE PHARMACEUTICALS ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 68682-750_5a94198e-c199-45cb-93fe-8a681b05ea89 68682-750 HUMAN PRESCRIPTION DRUG balsalazide disodium balsalazide disodium CAPSULE ORAL 20000718 NDA AUTHORIZED GENERIC NDA020610 Oceanside Pharmaceuticals BALSALAZIDE DISODIUM 750 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 68682-800_5bda7b1e-a301-4d1c-be34-9bca1fce8a9e 68682-800 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin GEL TOPICAL 20070726 NDA AUTHORIZED GENERIC NDA022070 Oceanside Pharmaceuticals TRETINOIN .05 g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 68682-880_db10c116-5cac-4d50-92dd-250729d0ee3c 68682-880 HUMAN PRESCRIPTION DRUG Prednicarbate emollient CREAM TOPICAL 19931029 NDA AUTHORIZED GENERIC NDA020279 Oceanside Pharmaceuticals PREDNICARBATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68682-900_9a40d23f-e2ac-428a-9827-c6cbfe6a8a71 68682-900 HUMAN PRESCRIPTION DRUG Erythromycin and Benzoyl Peroxide Erythromycin and Benzoyl Peroxide KIT 19841026 NDA AUTHORIZED GENERIC NDA050557 Oceanside Pharmaceuticals N 20181231 68682-901_9a40d23f-e2ac-428a-9827-c6cbfe6a8a71 68682-901 HUMAN PRESCRIPTION DRUG Erythromycin and Benzoyl Peroxide Erythromycin and Benzoyl Peroxide KIT 19841026 NDA AUTHORIZED GENERIC NDA050557 Oceanside Pharmaceuticals N 20181231 68682-938_c86e37ef-ce04-405b-a441-d9858fd1b445 68682-938 HUMAN PRESCRIPTION DRUG Tolcapone Tolcapone TABLET, FILM COATED ORAL 20040727 NDA AUTHORIZED GENERIC NDA020697 Oceanside Pharmaceuticals TOLCAPONE 100 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 68682-990_c26b6893-8264-4d4a-ac7e-1ddda933451e 68682-990 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate omeprazole, sodium bicarbonate POWDER, FOR SUSPENSION ORAL 20040615 NDA AUTHORIZED GENERIC NDA021636 Oceanside Pharmaceuticals OMEPRAZOLE; SODIUM BICARBONATE 20; 1680 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68682-991_c26b6893-8264-4d4a-ac7e-1ddda933451e 68682-991 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate omeprazole, sodium bicarbonate POWDER, FOR SUSPENSION ORAL 20040615 NDA AUTHORIZED GENERIC NDA021636 Oceanside Pharmaceuticals OMEPRAZOLE; SODIUM BICARBONATE 40; 1680 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68682-992_f408ad39-79ee-4733-accb-d090ef089094 68682-992 HUMAN PRESCRIPTION DRUG Fluocinonide fluocinonide CREAM TOPICAL 20140106 NDA AUTHORIZED GENERIC NDA021758 Oceanside Pharmaceuticals FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68682-993_ce950c7d-41a3-453f-8c12-34ee6faf9039 68682-993 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 OCEANSIDE PHARMACEUTICALS DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-994_ce950c7d-41a3-453f-8c12-34ee6faf9039 68682-994 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 OCEANSIDE PHARMACEUTICALS DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-997_ce950c7d-41a3-453f-8c12-34ee6faf9039 68682-997 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 OCEANSIDE PHARMACEUTICALS DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68682-998_ce950c7d-41a3-453f-8c12-34ee6faf9039 68682-998 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 19991228 ANDA ANDA075116 OCEANSIDE PHARMACEUTICALS DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68685-0001_6ceddeb1-5ab7-4cef-a2eb-aec70b897c5f 68685-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040221 UNAPPROVED MEDICAL GAS All American Medical Equipment, Inc. OXYGEN 99 L/100L E 20171231 68698-001_309c4ecf-9a4e-4b78-af8e-cb4bceadb631 68698-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20030101 UNAPPROVED MEDICAL GAS Oxygen Plus LLC OXYGEN 99 L/100L E 20171231 68703-002_4e023ebf-ad99-4105-976e-788ef1625502 68703-002 HUMAN OTC DRUG MediAc Carbo veg , Causticum, Hepar sulph, Silicea , Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20130115 UNAPPROVED HOMEOPATHIC Native Remedies LLC ACTIVATED CHARCOAL; CAUSTICUM; CALCIUM SULFIDE; SILICON DIOXIDE 30; 30; 30; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68703-003_48ce9c77-71b3-4ca7-8e39-a473078e19d0 68703-003 HUMAN OTC DRUG Be-Dry Equisetum arv TABLET ORAL 20130102 UNAPPROVED HOMEOPATHIC Native Remedies, LLC EQUISETUM ARVENSE TOP 6 [hp_C]/1 N 20181231 68703-004_1ab1357d-8220-4289-b896-2aa937edeba7 68703-004 HUMAN OTC DRUG SocialFear Relief Cacao, Gelsemium, Graphites, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20130117 UNAPPROVED HOMEOPATHIC Native Remedies, LLC COCOA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68703-005_0da3b1c6-6ac8-40de-8a20-8afae1ffb740 68703-005 HUMAN OTC DRUG Skin Dr Galium, Kali mur, Kali sulph, Nat mur, Urtica ur, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20130115 UNAPPROVED HOMEOPATHIC Native Remedies LLC GALIUM APARINE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM CHLORIDE; URTICA URENS 3; 6; 6; 6; 6 [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68703-006_5481ad2f-e078-4036-8014-691daf4041c9 68703-006 HUMAN OTC DRUG HaliTonic Carduus mar, Kali phos, Nat sulphuricum, Nux vom, Silicea, Acacia gum, Lactose, Magnesium stearate, Corn starch, Sucrose. TABLET ORAL 20121228 UNAPPROVED HOMEOPATHIC Native Remedies LLC SILYBUM MARIANUM SEED; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE 3; 6; 6; 3; 6 [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1 N 20181231 68703-007_797bb695-f030-42e5-b44a-4d66947aa0e0 68703-007 HUMAN OTC DRUG DeodoRite Calc sulph, Carduus mar, Galium, Mag phos, Merc solub, Silicea, Acacia gum, lactose, magnesium stearate, starch, sucrose TABLET ORAL 20130102 UNAPPROVED HOMEOPATHIC Native Remedies LLC CALCIUM SULFATE ANHYDROUS; SILYBUM MARIANUM SEED; GALIUM APARINE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MERCURIUS SOLUBILIS; SILICON DIOXIDE 6; 3; 3; 8; 30; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_X]/1 N 20181231 68703-008_1b020f40-cfcc-6a81-e054-00144ff88e88 68703-008 HUMAN OTC DRUG TremorSoothe Agaricus musc, Mag phos, Stramonium, Tarentula hisp TABLET ORAL 20130130 UNAPPROVED HOMEOPATHIC Silver Star Brands, Inc AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; DATURA STRAMONIUM; LYCOSA TARANTULA 6; 8; 6; 6 [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1 N 20181231 68703-009_c49d071d-21cd-443c-a782-8867b0c9dc7c 68703-009 HUMAN OTC DRUG VertiFree Bryonia , Cocculus, Gelsemium, Lobelia inf, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20100101 UNAPPROVED HOMEOPATHIC Native Remedies LLC BRYONIA ALBA ROOT; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; LOBELIA INFLATA 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68703-016_61adb221-415f-4b73-a739-c54f24828633 68703-016 HUMAN OTC DRUG AnemiCare Calc phos, Ferrum met, Ferrum phos TABLET ORAL 20130115 UNAPPROVED HOMEOPATHIC Native Remedies, LLC TRIBASIC CALCIUM PHOSPHATE; IRON; FERROSOFERRIC PHOSPHATE 8; 6; 8 [hp_X]/1; [hp_C]/1; [hp_X]/1 N 20181231 68703-017_310a00cb-fd87-4816-8ef4-2c5156a0c33e 68703-017 HUMAN OTC DRUG Bad Dream Sprinkles Aconitum nap 30C HPUS, Chamomilla 3X HPUS, Kali phos 6C HPUS, Nat sulphuricum 6C HPUS, Passiflora 3X HPUS GRANULE ORAL 20120701 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; MATRICARIA RECUTITA; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; PASSIFLORA INCARNATA FLOWERING TOP 30; 3; 6; 6; 3 [hp_C]/40mg; [hp_X]/40mg; [hp_C]/40mg; [hp_C]/40mg; [hp_X]/40mg N 20181231 68703-018_1b020f40-cfbc-6a81-e054-00144ff88e88 68703-018 HUMAN OTC DRUG MoodCalm Hyoscyamus, Kali phos, Nat sulphuricum, Tarentula hisp, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20120615 UNAPPROVED HOMEOPATHIC Silver Star Brands, Inc HYOSCYAMUS NIGER; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; LYCOSA TARANTULA 6; 6; 6; 6 [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 N 20181231 68703-024_c66c997b-b4b1-4efc-978a-871483f78be1 68703-024 HUMAN OTC DRUG ProState Relief Chimaphila umb, Clematis virg, Conium, Cubeba, Sabal TABLET ORAL 20130130 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CHIMAPHILA UMBELLATA; CLEMATIS VIRGINIANA TOP; CONIUM MACULATUM FLOWERING TOP; PIPER CUBEBA FRUIT; SAW PALMETTO 6; 6; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68703-026_5130eca8-a93d-4027-9c6c-a5f9427009e3 68703-026 HUMAN OTC DRUG Sniffly Sprinkles Allium cepa, Ferrum phos, Nat mur, Nuz vom, Pulsatilla GRANULE ORAL 20130130 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ONION; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS 6; 8; 6; 30; 6 [hp_C]/16mg; [hp_X]/16mg; [hp_X]/16mg; [hp_C]/16mg; [hp_C]/16mg N 20181231 68703-027_212ac96f-5c63-4cef-8cc0-a2e55d35d572 68703-027 HUMAN OTC DRUG Good Morning Mama Ferrum phos, Mentha pip, Nat mur, Nat phos, Nux vom, Zingiber GRANULE ORAL 20121227 UNAPPROVED HOMEOPATHIC Native Remedies, LLC FERROSOFERRIC PHOSPHATE; MENTHA PIPERITA; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; GINGER 6; 3; 6; 6; 30; 3 [hp_X]/13.33mg; [hp_X]/13.33mg; [hp_X]/13.33mg; [hp_X]/13.33mg; [hp_C]/13.33mg; [hp_X]/13.33mg N 20181231 68703-028_f484a88f-452d-44d7-82a3-cb88b0b18759 68703-028 HUMAN OTC DRUG Melancholy Lift Ignatia, Kali phos, Nat sulphuricum, Staphysagria TABLET ORAL 20120801 UNAPPROVED HOMEOPATHIC Native Remedies, LLC STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; DELPHINIUM STAPHISAGRIA SEED 6; 6; 6; 6 [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1 N 20181231 68703-029_cb3c7fda-f6e6-4520-9a01-017a9368f99f 68703-029 HUMAN OTC DRUG Tula Tantrum Tamer Chamomilla, Cina GRANULE ORAL 20120701 UNAPPROVED HOMEOPATHIC Native Remedies, LLC MATRICARIA RECUTITA; ARTEMISIA CINA PRE-FLOWERING TOP 6; 6 [hp_C]/50mg; [hp_C]/50mg N 20181231 68703-030_7f0a13d4-90a7-4d89-8fb1-f71cc9bed052 68703-030 HUMAN OTC DRUG CanTravel Cocculusm, Kali phos, Mentha pip, Pulsatilla, Zingiber GRANULE OCCLUSIVE DRESSING TECHNIQUE 20120801 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ANAMIRTA COCCULUS SEED; POTASSIUM PHOSPHATE, DIBASIC; MENTHA PIPERITA; PULSATILLA VULGARIS; GINGER 5; 6; 3; 6; 3 [hp_C]/40mg; [hp_C]/40mg; [hp_X]/40mg; [hp_C]/40mg; [hp_X]/40mg N 20181231 68703-031_1b021cdc-d5cd-15d5-e054-00144ff8d46c 68703-031 HUMAN OTC DRUG BladderWell Apis mel, Cantharis, Equisetum arv, Ferrum phos, Sarsaparilla, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20120629 UNAPPROVED HOMEOPATHIC Silver Star Brands, Inc APIS MELLIFERA; LYTTA VESICATORIA; EQUISETUM ARVENSE TOP; FERROSOFERRIC PHOSPHATE; SMILAX REGELII ROOT 30; 30; 30; 8; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_C]/1 N 20181231 68703-033_5939f755-e4c5-4505-b4be-3a35d2b015d9 68703-033 HUMAN OTC DRUG Birth-Heal Angelica, Arnica, Mag phos, Passiflora, Silicea TABLET ORAL 20120801 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ANGELICA SINENSIS ROOT; ARNICA MONTANA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PASSIFLORA INCARNATA FLOWERING TOP; SILICON DIOXIDE 6; 6; 8; 3; 8 [hp_X]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 68703-035_e54cf84c-cbe9-4b12-b584-2066829440b7 68703-035 HUMAN OTC DRUG BaniFlu Gelsemium, Influenzinum, Nux vom TABLET ORAL 20130102 UNAPPROVED HOMEOPATHIC Native Remedies, LLC GELSEMIUM SEMPERVIRENS ROOT; INFLUENZA A VIRUS A/NEW CALEDONIA/20/99 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/PANAMA/2007/99 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/HONG KONG/330/2001 ANTIGEN (PROPIOLACTONE INACTIVATED); STRYCHNOS NUX-VOMICA SEED 30; 30; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68703-036_66b26b36-b184-4aea-97a9-588f16b6550c 68703-036 HUMAN OTC DRUG AgoraFear Relief Aconitum nap, Calc carb, Nat carb TABLET OCCLUSIVE DRESSING TECHNIQUE 20120901 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CARBONATE 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68703-037_9d071d82-8b78-4155-9140-aae04f49f1f1 68703-037 HUMAN OTC DRUG Triple Complex Brain Tonic Calc phos, Kali phos, Nat mur TINCTURE ORAL 20130304 UNAPPROVED HOMEOPATHIC Native Remedies, LLC TRIBASIC CALCIUM PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68703-038_3289f39c-d2f6-4b4d-a9ef-f10495cc64eb 68703-038 HUMAN OTC DRUG Triple Complex BronchoSoothe Kali phos, Mag phos, Nat sulphuricum TINCTURE ORAL 20130320 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM SULFATE 6; 8; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68703-039_1ad693b6-8cdd-1a36-e054-00144ff8d46c 68703-039 HUMAN OTC DRUG BrightSpark Arg nit, Arsenicum iod, Hyoscyamus, Veratrum alb TABLET ORAL 20121004 UNAPPROVED HOMEOPATHIC Silver Star Brands, Inc SILVER NITRATE; ARSENIC TRIIODIDE; HYOSCYAMUS NIGER; VERATRUM ALBUM ROOT 6; 30; 30; 30 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68703-040_6c5c5d19-9db2-4954-9b67-915dc2c16b4f 68703-040 HUMAN OTC DRUG CoughEx Sprinkles Aconitum nap, Hepar sulph calc, Kali mur, Mag phos, Rumex crisp GRANULE ORAL 20121127 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; CALCIUM SULFIDE; POTASSIUM CHLORIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUMEX CRISPUS ROOT 30; 6; 6; 8; 6 [hp_C]/16mg; [hp_C]/16mg; [hp_X]/16mg; [hp_X]/16mg; [hp_C]/16mg N 20181231 68703-042_5b57ed03-0fba-444b-9a42-349712bc12f5 68703-042 HUMAN OTC DRUG Triple Complex Diabetonic Calc phos, Kali sulph, Nat sulphuricum TINCTURE ORAL 20130329 UNAPPROVED HOMEOPATHIC Native Remedies, LLC TRIBASIC CALCIUM PHOSPHATE; POTASSIUM SULFATE; SODIUM SULFATE 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68703-043_8f8a347b-b8d4-4df1-9d71-bb97da8d924a 68703-043 HUMAN OTC DRUG Triple Complex Digestion Tonic Calc phos, Kali phos, Nat Phos TINCTURE ORAL 20130403 UNAPPROVED HOMEOPATHIC Native Remedies, LLC TRIBASIC CALCIUM PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68703-045_b1986c97-b2f3-4433-b5cb-2a7cc0e0c260 68703-045 HUMAN OTC DRUG FluGo Allium cepa, Arsenicum iod, Belladonna, Ferrum phos, Nat mur TABLET ORAL 20120901 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ONION; ARSENIC TRIIODIDE; ATROPA BELLADONNA; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE 30; 30; 30; 8; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1 N 20181231 68703-047_291cf044-01d9-409f-9fcb-09cdc246f734 68703-047 HUMAN OTC DRUG iBaba Chamomilla, Mag phos GRANULE ORAL 20130107 UNAPPROVED HOMEOPATHIC Native Remedies, LLC MATRICARIA RECUTITA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6; 6 [hp_C]/40mg; [hp_C]/40mg N 20181231 68703-049_838468cd-25e2-4df4-abc4-ddc572984215 68703-049 HUMAN OTC DRUG K-OK Kiddie Calmer Aconitinum, silicea GRANULE ORAL 20120801 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; SILICON DIOXIDE 6; 6 [hp_C]/100mg; [hp_C]/100mg N 20181231 68703-051_b51045f3-ae0f-423e-99ac-389143c0ec98 68703-051 HUMAN OTC DRUG Triple Complex Mood Tonic Kali phos, Nat phos, Nat sulph TINCTURE ORAL 20130403 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68703-052_6d49ebc2-3915-487c-ab53-09e391c8011a 68703-052 HUMAN OTC DRUG Moms Magic Trauma Sprinkles Aconitum nap, Arnica, Chamomilla, Passiflora, Scutellaria, Citric acid, corn starch, potassium sorbate, sucrose GRANULE ORAL 20130117 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; ARNICA MONTANA; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA 30; 6; 30; 3; 3 [hp_C]/16mg; [hp_C]/16mg; [hp_C]/16mg; [hp_X]/16mg; [hp_X]/16mg N 20181231 68703-053_166cc43d-5c7d-4da8-9ca0-6dab8598881d 68703-053 HUMAN OTC DRUG N-Con Tonic Calc fluor, Equisetum arv, Nat phos, Nat sulphuricum, Pulsatilla, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20130116 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM FLUORIDE; EQUISETUM ARVENSE TOP; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; PULSATILLA VULGARIS 6; 3; 6; 6; 3 [hp_C]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1 N 20181231 68703-054_867b2237-4439-4cd5-a1d3-b04c0921f071 68703-054 HUMAN OTC DRUG Triple Complex Calm Tonic Ferrum phos, Kali phos, Mag phos TINCTURE ORAL 20130403 UNAPPROVED HOMEOPATHIC Native Remedies, LLC FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 8; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68703-055_a53d5003-fbaf-48da-a604-cf5eac543493 68703-055 HUMAN OTC DRUG Triple Complex NicoTonic Kali ohosphoricum, Natrum muriaticum, Natrum ohosphoricum TINCTURE ORAL 20130403 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68703-056_a7ce84ba-001a-4a0f-89a6-6f2689ccacbf 68703-056 HUMAN OTC DRUG OralSoothe Calc fluor, Calc phos, Chamomilla, Chamomilla, Passiflora GRANULE ORAL 20130108 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP 8; 8; 3; 6; 3 [hp_X]/16mg; [hp_X]/16mg; [hp_X]/16mg; [hp_C]/16mg; [hp_X]/16mg N 20181231 68703-066_06f5a319-a80b-42fa-b8fc-dc3d13e0f8fb 68703-066 HUMAN OTC DRUG RealHeal Arnica, Bellis, Chamomilla, Mag phos, Symphytum, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20130121 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARNICA MONTANA; BELLIS PERENNIS; MATRICARIA RECUTITA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; COMFREY ROOT 3; 3; 6; 8; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 68703-067_5e066355-00fe-48be-be6e-a7ad1d148e74 68703-067 HUMAN OTC DRUG RosaRex Calc phos, Calc sil, Carbo veg, Kali brom, Viola tri TABLET ORAL 20120801 UNAPPROVED HOMEOPATHIC Native Remedies, LLC TRIBASIC CALCIUM PHOSPHATE; CALCIUM SILICATE; ACTIVATED CHARCOAL; POTASSIUM BROMIDE; VIOLA TRICOLOR 8; 30; 30; 30; 6 [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68703-069_34e51e9d-9076-4013-b800-33276a1a1a89 68703-069 HUMAN OTC DRUG Triple Complex Sleep Tonic Cacl phos, Calc sulph, Mag phos TINCTURE ORAL 20130404 UNAPPROVED HOMEOPATHIC Native Remedies, LLC TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68703-070_29cab8e0-1c0f-4c09-99f7-f65f23e2b467 68703-070 HUMAN OTC DRUG TripleComplex Slimmers Assist Calc fluor, Calc phos, Hali phos TINCTURE ORAL 20130404 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68703-071_3af572fc-0c99-4d5f-ba43-95f2568d6892 68703-071 HUMAN OTC DRUG Throar Dr. Belladonna, Gelsemium, Hepar sulph calc, Merc sol, Acacia gum, lactose, magnesium stearate, corn starch, sucrose TABLET ORAL 20130124 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE; MERCURIUS SOLUBILIS 30; 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 68703-072_d3d8098e-1ade-4f34-9025-8b1b347f6287 68703-072 HUMAN OTC DRUG Triple Complex UT Tonic Ferrum phos, Kali sulp, Nat phos TINCTURE ORAL 20130424 UNAPPROVED HOMEOPATHIC Native Remedies, LLC FERROSOFERRIC PHOSPHATE; POTASSIUM SULFATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68703-074_ca968f76-9349-4fae-9f28-ac920ea03270 68703-074 HUMAN OTC DRUG Kidney Stone Clear Belladona, Berberis vulgaris, Calc carb, Cantharis, Lycopodium TINCTURE ORAL 20130327 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYTTA VESICATORIA; LYCOPODIUM CLAVATUM SPORE 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 68703-075_511338f6-3dd0-462d-ba82-5bbe166521ec 68703-075 HUMAN OTC DRUG Scab-Ease Itch Relief Arum triph, Staphysagria, Viola tri TINCTURE ORAL 20130320 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARISAEMA TRIPHYLLUM ROOT; DELPHINIUM STAPHISAGRIA SEED; VIOLA TRICOLOR 6; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 68703-076_f1e53ef8-eefb-4f83-98e7-fd8c1d1ef9a3 68703-076 HUMAN OTC DRUG Acid Free-Flux Calc phos, Carbo veg, Mag carb, Nat phos, Silicea TINCTURE ORAL 20130424 UNAPPROVED HOMEOPATHIC Native Remedies, LLC TRIBASIC CALCIUM PHOSPHATE; ACTIVATED CHARCOAL; MAGNESIUM CARBONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE 6; 6; 6; 6; 6 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68703-077_f445d7a3-55c0-434c-b7b2-f5e2b7a14a65 68703-077 HUMAN OTC DRUG Anal Itch Assist Aesculus, Cina, Croton, Fagopyrum, Kali sulph, Sulphur TINCTURE ORAL 20131021 UNAPPROVED HOMEOPATHIC Native Remedies, LLC HORSE CHESTNUT; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; FAGOPYRUM ESCULENTUM; POTASSIUM SULFATE; SULFUR 12; 6; 6; 12; 6; 12 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL E 20171231 68703-078_af9ebf8c-e2bc-4fe0-a0ef-55dc3cfd4549 68703-078 HUMAN OTC DRUG Anger Soothe Chamomilla, Lycopodium, Nux vomica TINCTURE ORAL 20130404 UNAPPROVED HOMEOPATHIC Native Remedies, LLC MATRICARIA RECUTITA; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-079_3223487b-1cac-4880-8048-028439aced0b 68703-079 HUMAN OTC DRUG Boil-Rx Calc sil, Echinacea, Hepar sulph, Silica mar, Sulfur iod TINCTURE ORAL 20130424 UNAPPROVED HOMEOPATHIC Native Remedies, LLC CALCIUM SILICATE; ECHINACEA, UNSPECIFIED; CALCIUM SULFIDE; SILICON DIOXIDE; SULFUR IODIDE 6; 6; 6; 8; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-080_34cf01a7-038d-4211-a0a4-ef452e54efc5 68703-080 HUMAN OTC DRUG Conjunct-a-Clear Euphrasia, Graphites, Mer sol, Pulsatilla, Psorinum TINCTURE ORAL 20130424 UNAPPROVED HOMEOPATHIC Native Remedies, LLC EUPHRASIA STRICTA; GRAPHITE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; SCABIES LESION LYSATE (HUMAN) 6; 6; 6; 12; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-081_c9b87567-00b5-41bd-96dd-3180b46aed1f 68703-081 HUMAN OTC DRUG Conjunct-a-Clear Wash Agrimony, Arg nit, Calendula, Euphrasia TINCTURE ORAL 20130424 UNAPPROVED HOMEOPATHIC Native Remedies, LLC AGRIMONIA EUPATORIA; SILVER NITRATE; CALENDULA OFFICINALIS FLOWERING TOP; EUPHRASIA STRICTA 8; 8; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 68703-082_e7738006-b17e-4bda-ba39-e0b61482251a 68703-082 HUMAN OTC DRUG FibroFree Complex Bryonia, Calc carb, Ranunc bulb, Rhus tox, Staphysag TINCTURE ORAL 20130425 UNAPPROVED HOMEOPATHIC Native Remedies, LLC BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; DELPHINIUM STAPHISAGRIA SEED 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-083_a915c04b-7c1c-4ebe-bf9e-519e0182a458 68703-083 HUMAN OTC DRUG Gout Gone Antimoium crud, Benzoic ac, Ledum, Nux vom, Quercus, Rhododendron, Silicea TINCTURE ORAL 20130415 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ANTIMONY TRISULFIDE; BENZOIC ACID; LEDUM PALUSTRE TWIG; STRYCHNOS NUX-VOMICA SEED; QUERCUS ROBUR NUT; RHODODENDRON AUREUM LEAF; SILICON DIOXIDE 6; 6; 6; 6; 12; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL E 20171231 68703-084_4c831aa9-ba38-4c0a-9890-3bd61f07614b 68703-084 HUMAN OTC DRUG HayFever Fighter Allium cepa, Arsen iod, Euphrasia, Kali bich, Sambucus, Wyethia TINCTURE ORAL 20130411 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ONION; ARSENIC TRIIODIDE; EUPHRASIA STRICTA; POTASSIUM DICHROMATE; SAMBUCUS CANADENSIS FLOWER; WYETHIA HELENIOIDES ROOT 6; 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-085_cf06c8c2-da4d-4f5d-be57-a1b4acecc4ac 68703-085 HUMAN OTC DRUG Headache Soothe Chamomilla, Cinchona, Kali phos, Mag phos, Nux vom TINCTURE ORAL 20130411 UNAPPROVED HOMEOPATHIC Native Remedies, LLC MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED 12; 12; 6; 12; 12 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 68703-086_0a20e1b2-eed6-408d-b258-56d568d782a5 68703-086 HUMAN OTC DRUG Hive Away Ammonium carbonicum, Apis mellifica, Chamomilla, Rhus toxicodendron, Urtica urens TINCTURE ORAL 20130411 UNAPPROVED HOMEOPATHIC Native Remedies, LLC AMMONIUM CARBONATE; APIS MELLIFERA; MATRICARIA RECUTITA; TOXICODENDRON PUBESCENS LEAF; URTICA URENS 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-087_2a672b49-3204-4ce5-8798-8574aae40a9f 68703-087 HUMAN OTC DRUG Inflammago Arnica, Dulcamara, Berberis, Bryonia, Rhus tox TINCTURE ORAL 20130410 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARNICA MONTANA; SOLANUM DULCAMARA TOP; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; TOXICODENDRON PUBESCENS LEAF 6; 6; 6; 6; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-088_630b52cc-a15f-4ebb-8bbc-022c2f22b154 68703-088 HUMAN OTC DRUG Leg Cramp Away Calc phos, Mag phos, Nux vom, Rhus tox TINCTURE ORAL 20130410 UNAPPROVED HOMEOPATHIC Native Remedies, LLC TRIBASIC CALCIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF 6; 6; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-089_cd9d4d3a-89db-44e3-b67a-508ae6dad583 68703-089 HUMAN OTC DRUG Mucus-Clear Kali muriaticum, Kali sulphuricum, Kali bichromicum TINCTURE ORAL 20130325 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM DICHROMATE; POTASSIUM CHLORIDE; POTASSIUM SULFATE 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 68703-090_080b1975-6256-4e2f-9aed-656dcd384eeb 68703-090 HUMAN OTC DRUG Oral Assist Belladonna 30C HPUS, Ferrum phosphoricum 12 X HPUS, Hepar sulphuris 12C HPUS, Mercurius solubilis 12C HPUS, Salicylicum acidum 6C HPUS, Silicea 6X HPUS TINCTURE ORAL 20130409 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ATROPA BELLADONNA; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; SALICYLIC ACID; SILICON DIOXIDE 30; 12; 12; 12; 6; 6 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL E 20171231 68703-091_e0d5f30c-33a3-468f-bb5b-07dc73bb2bde 68703-091 HUMAN OTC DRUG QueaseX Anti Nausea Drops Cahmomilla, Ipecac, Nux vom, Pulsatilla, Zingiber TINCTURE ORAL 20130409 UNAPPROVED HOMEOPATHIC Native Remedies, LLC MATRICARIA RECUTITA; IPECAC; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; GINGER 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-092_10a18e2a-2e17-4627-8118-6bb2d3335dc3 68703-092 HUMAN OTC DRUG SAD Soother Alumina, Aurum met, Calc carb, Kali phos, Nar mur TINCTURE ORAL 20130325 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ALUMINUM OXIDE; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE 30; 30; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 68703-093_53952697-6db3-4d73-bc15-b197a79c432f 68703-093 HUMAN OTC DRUG Sinus Soothe Kali bich, Pulsatilla, Hepar sulph, Thuja occ, Spigelia anth TINCTURE ORAL 20130408 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM DICHROMATE; PULSATILLA VULGARIS; CALCIUM SULFIDE; THUJA OCCIDENTALIS LEAFY TWIG; SPIGELIA ANTHELMIA 6; 6; 6; 12; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-094_f9e1b5d6-a6f3-4d4b-a282-3a5f93e8a337 68703-094 HUMAN OTC DRUG StyeGone Pulsatilla, Staphysagria, Psorinum, Graphites TINCTURE ORAL 20130327 UNAPPROVED HOMEOPATHIC Native Remedies, LLC PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; SCABIES LESION LYSATE (HUMAN); GRAPHITE 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 68703-095_05bff9ca-58ea-4c94-847b-ebba5d80e5a7 68703-095 HUMAN OTC DRUG Sweat Less Argentum nit, Castoreum, Lupulus, Nat mur, Syphilinum TINCTURE ORAL 20130408 UNAPPROVED HOMEOPATHIC Native Remedies, LLC SILVER NITRATE; CASTOR FIBER SCENT GLAND SECRETION; HOPS; SODIUM CHLORIDE; TREPONEMIC SKIN CANKER HUMAN 6; 30; 30; 6; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL E 20171231 68703-096_f01db789-926e-4aee-b0f6-d2123e18e7d8 68703-096 HUMAN OTC DRUG Tic Tamer Hyoscyamus, Zinc met, Cina, Chamomilla TINCTURE ORAL 20130329 UNAPPROVED HOMEOPATHIC Native Remedies, LLC HYOSCYAMUS NIGER; ZINC; ARTEMISIA CINA PRE-FLOWERING TOP; MATRICARIA RECUTITA 30; 30; 30; 12 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-097_1bc086e7-7bf3-4435-8191-63ad1a117fa7 68703-097 HUMAN OTC DRUG Vagi-Soothe Calc carb, Kreosotum, Lycopodium, Merc sol, Sepia TINCTURE ORAL 20130329 UNAPPROVED MEDICAL GAS Native Remedies, LLC OYSTER SHELL CALCIUM CARBONATE, CRUDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SEPIA OFFICINALIS JUICE 6; 12; 12; 30; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-098_2e94be05-4919-4788-b554-c9caf8497ac9 68703-098 HUMAN OTC DRUG Vagi-Clear Kali phosphoricum, Kreosotum, Nitricum acidum, Pulsatilla, Sepia TINCTURE ORAL 20130405 UNAPPROVED HOMEOPATHIC Native Remedies, POTASSIUM PHOSPHATE, DIBASIC; WOOD CREOSOTE; NITRIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 6; 6; 6; 6; 6 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL E 20171231 68703-099_23db1934-668a-4802-ab35-06359ec92272 68703-099 HUMAN OTC DRUG Red Eye Reducer Aconitum napellus, Allium cepa, Ambrosia artemisiaefolia, Apis mellifica, Arsenicum album, Belladonna, Cactus grandiflorus, Dulcamara, Euphrasia officinalis, Gelsemium sempervirens, Graphites, Hamamelis virginiana, Hepar sulphuris calcareum, Kali iodatum, Mercurius vivus, Natrum muriaticum, Pulsatilla, Rhus toxicodendron, Ruta graveolens, Sabadilla, Sulphur, Thuja occidentalis, Zincum metallicum SPRAY ORAL 20130713 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; ONION; AMBROSIA ARTEMISIIFOLIA; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; SELENICEREUS GRANDIFLORUS STEM; SOLANUM DULCAMARA TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; POTASSIUM IODIDE; MERCURY; SODIUM CHLORIDE; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SCHOENOCAULON OFFICINALE SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-100_1b022d6f-303c-140c-e054-00144ff8d46c 68703-100 HUMAN OTC DRUG AppetiteGo Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria flos, Anacardium orientale, Antimonium crudum, Calcarea carbonica, Castanea sativa flos, Cortisone aceticum, Fucus vesiculosus, Hypothalamus , Kali bichromicum, Oleander, Pituitarum posterium, Sabadilla, Staphysagria, Thyroidinum SPRAY ORAL 20130604 UNAPPROVED HOMEOPATHIC Silver Star Brands EPINEPHRINE; CORTICOTROPIN; AGRIMONIA EUPATORIA FLOWER; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CASTANEA SATIVA FLOWER; CORTISONE ACETATE; FUCUS VESICULOSUS; BOS TAURUS HYPOTHALAMUS; POTASSIUM DICHROMATE; NERIUM OLEANDER LEAF; SUS SCROFA PITUITARY GLAND; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-101_cd809f51-1e5d-4cdc-8acf-6559550ba899 68703-101 HUMAN OTC DRUG BoneBuildPro Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Equisetum hyemale, Hekla lava, Phosphorus, Silicea SPRAY ORAL 20130626 UNAPPROVED HOMEOPATHIC Native Remedies, LLC OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; EQUISETUM HYEMALE; HEKLA LAVA; PHOSPHORUS; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-102_c9e93a53-153e-4005-bcab-871465c6917a 68703-102 HUMAN OTC DRUG AllergyEase Grain and Gluten Arsenicum album, Bryonia alba, Histamimum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum muriaticum, Pulsatilla, Sabadilla, Secale cornutum, Sulphur SPRAY ORAL 20130605 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED; CLAVICEPS PURPUREA SCLEROTIUM; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-103_674ea646-d803-4587-a937-8202693c37e6 68703-103 HUMAN OTC DRUG AllergyEase Northeastern Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agraphis nutans, Allium cepa, Collinsonia canadensis, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crisp, Sabadilla, Salvia officinalis, Tanacetum vulgare, Trofolium pratense, Vinca minor SPRAY ORAL 20130627 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; HYACINTHOIDES NON-SCRIPTA; ONION; COLLINSONIA CANADENSIS ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; SAGE; TANACETUM VULGARE TOP; TRIFOLIUM PRATENSE FLOWER; VINCA MINOR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-104_f8398470-313b-4c72-abcd-4b6c833f70ad 68703-104 HUMAN OTC DRUG TMJ Ease Baptisia tinctoria, Calcarea fluorica, Causticum, Hepar sulphuris calcareum, Hypericum perforatum, Ignatia amara, Kalmia latifolia, Nux vomica, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis, Symphytum officinale SPRAY ORAL 20130627 UNAPPROVED HOMEOPATHIC Native Remedies, LLC BAPTISIA TINCTORIA ROOT; CALCIUM FLUORIDE; CAUSTICUM; CALCIUM SULFIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; KALMIA LATIFOLIA LEAF; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; COMFREY ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; 1/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-105_01309f97-f58e-43fa-8fe8-566eea137072 68703-105 HUMAN OTC DRUG VaricoGo Aesculus hippocastanum, Arnica montana, Calcarea fluorica, Carduus marianus, Carbo vegetabilis, Collinsonia canadensis, Echinacea purpurea, Hamamelis virginiana, Lachesis mutus, Pulsatilla, Secale cornutum SPRAY ORAL 20130626 UNAPPROVED HOMEOPATHIC Native Remedies, LLC HORSE CHESTNUT; ARNICA MONTANA; CALCIUM FLUORIDE; ACTIVATED CHARCOAL; SILYBUM MARIANUM SEED; COLLINSONIA CANADENSIS ROOT; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LACHESIS MUTA VENOM; PULSATILLA VULGARIS; CLAVICEPS PURPUREA SCLEROTIUM 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-106_ed5fd0fd-0872-473e-ad82-7c6486421d92 68703-106 HUMAN OTC DRUG Gallbladder Dr. Berberis vulgaris, Bryonia alba, Carduus marianus, Chelidonium majus, Cholesterinum, Chichona officinalis, Colocynthis, Dioscorea villosa, Lycopodium clavatum, Natrum sulphuricum SPRAY ORAL 20130722 UNAPPROVED HOMEOPATHIC Native Remedies, LLC BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-107_1fdf4ff1-b1b0-46dc-931c-974ef5c01c9f 68703-107 HUMAN OTC DRUG CataractClear Calc carb, Calc fluor, Casuticum, Cineraria, Euphrasia, Napthalinum, Nat mur, Phos, Quassia, Silicea SPRAY ORAL 20130724 UNAPPROVED HOMEOPATHIC Native Remedies, LLC OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; JACOBAEA MARITIMA; EUPHRASIA STRICTA; NAPHTHALENE; SODIUM CHLORIDE; PHOSPHORUS; QUASSIA AMARA WOOD; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-108_dae22f30-af57-4cf3-aa2d-968f3626f7d0 68703-108 HUMAN OTC DRUG AllergyEase Desert Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Alfalfa, Allium cepa, Ambrosia artemisiaefolia, Cortisone aceticum, Erechtites hieracifolia, Erigeron canadensis, Euonymus atropurpureus, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Sabadilla, Stramonium, Triticum repens SPRAY ORAL 20130628 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ALFALFA; ONION; AMBROSIA ARTEMISIIFOLIA; CORTISONE ACETATE; ERECHTITES HIERACIIFOLIUS; CONYZA CANADENSIS; EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; DATURA STRAMONIUM; ELYMUS REPENS ROOT 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-109_1b00a71e-2207-7392-e054-00144ff88e88 68703-109 HUMAN OTC DRUG AllergyEase Great Lakes Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolia, Chelidonium majus, Chenopodium vulvaria, Cichorium intybus, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Hereda helix, Histaminum hydrochloricum, Junglans cinerea, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Pulsatilla nuttalliana, RNA, Sabadilla, Teucrium scorodonia SPRAY ORAL 20130628 UNAPPROVED HOMEOPATHIC Silver Star Brands, Inc CHELIDONIUM MAJUS; CHENOPODIUM VULVARIA; CHICORY ROOT; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; ANEMONE PATENS; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; TEUCRIUM SCORODONIA FLOWERING TOP; ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; AMBROSIA ARTEMISIIFOLIA 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-110_0617f99f-d07e-4bbc-a999-92dd05e4c44d 68703-110 HUMAN OTC DRUG AllergyEase Hawaii Adenosinum cyclophosphoricum, Adrenalium, Adrenocorticotrophin, Allium cepa, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juniperus virginiana, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Runex crisp, Sabadilla SPRAY ORAL 20130607 UNAPPROVED HOMEOPATHIC Native Remedies ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; CORTISONE ACETATE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-111_8adb5cf3-9e65-4f3c-9c65-32e93fc806fc 68703-111 HUMAN OTC DRUG AllergyEase Pacific Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Alfalfa, Allium cepa, Bellis perennis, Conium maculatum, Cortisone aceticum, Equisetum hyemale, Euphrasia officinalis, Fogopyrum esculentum, Galphimia glauca, Histaminum hydrochloricum, kali muriaticum, Millefolium, Mucosa nasalis suis, Natrum muriaticum, Prunus spinosa, RNA, Sabadilla, Solidago virgaurea SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ALFALFA; ONION; BELLIS PERENNIS; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EQUISETUM HYEMALE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; ACHILLEA MILLEFOLIUM; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PRUNUS SPINOSA FLOWER BUD; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 h/59mL; h/59mL; h/59mL; h/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; h/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-112_ba29c138-4083-4c10-a745-c5b0e8f81ee7 68703-112 HUMAN OTC DRUG AllergyEase Plains Absinthium, Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemissfolia, Caulophyllum thalictroides, Conium maculatum, Cortisone aceticum, Euphrasia officinalis, Fagopyrum esculentum, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Melilotus officinalis, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Secale cornutum SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC Native Remedies, LLC WORMWOOD; ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; AMBROSIA ARTEMISIIFOLIA; CAULOPHYLLUM THALICTROIDES ROOT; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; EUPHRASIA STRICTA; FAGOPYRUM ESCULENTUM; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; MELILOTUS OFFICINALIS TOP; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; CLAVICEPS PURPUREA SCLEROTIUM 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-113_7ce80488-ffe6-4c53-bf01-14735dd5766e 68703-113 HUMAN OTC DRUG AllergyEase Rocky Mtns Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, Agrostemma githago, Ailanthus glandulosus, Allium cepa, Cortisone aceticum, Cynodon dactylon, Equisetum hyemale, Euprhrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Platanus, Populus candicans, RNA, Sabadilla, Solidago virgaurea SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; AGRIMONIA EUPATORIA; AGROSTEMMA GITHAGO SEED; AILANTHUS ALTISSIMA FLOWERING TWIG; ONION; CORTISONE ACETATE; CYNODON DACTYLON; EQUISETUM HYEMALE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PLATANUS X ACERIFOLIA WHOLE; POPULUS BALSAMIFERA LEAF BUD; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SOLIDAGO VIRGAUREA FLOWERING TOP 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 59; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-114_fda2dd63-4370-4614-9e1c-68dfd169db92 68703-114 HUMAN OTC DRUG AllergyEase Southern Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Alnus serrulata, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Nasturtium, Natrum muriaticum, Rhus tox, RNA, Sabadilla, Sassafras officinale SPRAY ORAL 20130701 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; ALNUS SERRULATA BARK; CENTAUREA BENEDICTA; CHICORY ROOT; CORTISONE ACETATE; MUCUNA PRURIENS FRUIT TRICHOME; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; NASTURTIUM OFFICINALE; SODIUM CHLORIDE; TOXICODENDRON PUBESCENS LEAF; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SASSAFRAS ALBIDUM ROOT BARK 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; h/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-115_99d49750-ba00-4005-aa1e-11600f1bc6e3 68703-115 HUMAN OTC DRUG AllergyEase Southwestern Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Asarum canadense, Cortisone aceticum, Eupatorium aromaticum, Euphrasia officinalis, Fraxinus americana, Galphimia glauca, Helianthus annus, Histaminum hydrochloricum, Juniperus virginiana, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Plantago major, RNA, Rumex crispus, Sabadilla, Senecio jacobaea SPRAY ORAL 20130702 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; CORTICOTROPIN; ONION; ASARUM CANADENSE ROOT; CORTISONE ACETATE; AGERATINA AROMATICA ROOT; EUPHRASIA STRICTA; FRAXINUS AMERICANA BARK; GALPHIMIA GLAUCA FLOWERING TOP; HELIANTHUS ANNUUS FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS VIRGINIANA TWIG; POTASSIUM CHLORIDE; SUS SCROFA NASAL MUCOSA; SODIUM CHLORIDE; PLANTAGO MAJOR; SACCHAROMYCES CEREVISIAE RNA; RUMEX CRISPUS ROOT; SCHOENOCAULON OFFICINALE SEED; JACOBAEA VULGARIS 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-116_7ef8d2be-6f2a-440c-8ca0-7522d9c86ef9 68703-116 HUMAN OTC DRUG AllergyEase Weather Changes Alumen, Benzoicum acidum, Cadmium sulphuricum, Chelidonium majus, Colchicum autumnale, Dulcamara, Hypothalamus, Manganum aceticum, Mercurius solubilis, Natrum muriaticum, Nitricum acidum, Phosphorus, Ranunculus bulbosus, Rhododendron chrysanthum, Thyroidinum SPRAY ORAL 20130724 UNAPPROVED HOMEOPATHIC Native Remedies, LLC POTASSIUM ALUM; BENZOIC ACID; CADMIUM SULFATE; CHELIDONIUM MAJUS; COLCHICUM AUTUMNALE BULB; SOLANUM DULCAMARA TOP; BOS TAURUS HYPOTHALAMUS; MANGANESE ACETATE TETRAHYDRATE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORUS; RANUNCULUS BULBOSUS; RHODODENDRON AUREUM LEAF; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-117_f87e61c9-0981-45cb-8b3b-5f9267acefaa 68703-117 HUMAN OTC DRUG AllerguEase Food and Chemical Allium sativum, Anacardium orientale, Apis mellifica, Gambogia, Mercuris solubilis, Natrum carbonicum, Nitricum acidum, Nux vomica, Phosphorus, Pulsatilla, Sulphur SPRAY ORAL 20130702 UNAPPROVED HOMEOPATHIC Native Remedies, LLC GARLIC; SEMECARPUS ANACARDIUM JUICE; APIS MELLIFERA; GAMBOGE; MERCURIUS SOLUBILIS; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-118_8a2169ad-fa57-45ee-be7f-6aef9411687d 68703-118 HUMAN OTC DRUG AllergyEase Animal Hair and Dander Aralia racemosa, Arsenicum album, Histaminum hydrochloricum, Nux vomica, Oleum animale, Phosphorus, Silicea, Sulphur SPRAY ORAL 20130612 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE; HISTAMINE DIHYDROCHLORIDE; STRYCHNOS NUX-VOMICA SEED; CERVUS ELAPHUS HORN OIL; PHOSPHORUS; SILICON DIOXIDE; SULFUR 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-119_fa322b3d-482e-4e84-a197-56722865a84b 68703-119 HUMAN OTC DRUG AllergyEase Dairy Aethusa cynapium, Anacardium orientale, Apium graveolens, Calc carbonica, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lac defloratum, Lac vaccinum, Pulsatilla, Sepia, Sulphur SPRAY ORAL 20130612 UNAPPROVED HOMEOPATHIC Native Remedies, LLC AETHUSA CYNAPIUM; SEMECARPUS ANACARDIUM JUICE; CELERY SEED; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; SKIM MILK; COW MILK; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; SULFUR 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-120_39702d68-c692-4fb8-bd08-2f29043ce900 68703-120 HUMAN OTC DRUG AllergyEase Dust Mites and Roaches Aralia racemosa, Blatta americana, Blatta orientalis, Chelidonium majus, Hydrastis canadensis, Linum usitatissimum, Phosphorus, Sulphur, Trifolium pratense SPRAY ORAL 20130703 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARALIA RACEMOSA ROOT; PERIPLANETA AMERICANA; BLATTA ORIENTALIS; CHELIDONIUM MAJUS; GOLDENSEAL; FLAX SEED; PHOSPHORUS; SULFUR; TRIFOLIUM PRATENSE FLOWER 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-121_2893d162-1459-4532-9676-cbc68b5b2f51 68703-121 HUMAN OTC DRUG AllergyEase Egg and Meat Calcarea carbonica, Causticum, Chloramphenicolum, Colchicum autumnale, Gambonia, Histaminum hydrochloricum, Hydrastis canadensis, Ichthyolum, Lecithin, Ova tosta, Ovi gallinae pellicula, Pulsatilla, Pyrogenium SPRAY ORAL 20130626 UNAPPROVED HOMEOPATHIC Native Remedies, LLC OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; CHLORAMPHENICOL; COLCHICUM AUTUMNALE BULB; GAMBOGE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; ICHTHAMMOL; EGG PHOSPHOLIPIDS; EGG SHELL, COOKED; EGG SHELL MEMBRANE; PULSATILLA VULGARIS; RANCID BEEF 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-122_c8284a2e-16a7-46bb-ba7a-4ef4362e5468 68703-122 HUMAN OTC DRUG AllergyEase Scent and Phenol Acetaldehyde, Arsenicum album, Balsamum peruvianum, Calcarea carbonica, Carbolicum acidum, Conium, Coumarinum, Crocus sativus, Histaminum hydrochloricum, Lachesis, Lycopodium, Phosphorus, Sepia SPRAY ORAL 20130729 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACETALDEHYDE; ARSENIC TRIOXIDE; BALSAM PERU; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHENOL; CONIUM MACULATUM FLOWERING TOP; COUMARIN; SAFFRON; HISTAMINE DIHYDROCHLORIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; SEPIA OFFICINALIS JUICE 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-123_df91ffd7-cbe5-4417-9e99-4fcb8c6e664f 68703-123 HUMAN OTC DRUG AllergyEase Nut and Seed Adrenalinum, Chelidonium majus, Cucurbita pepo semen, Hsitaminum hydrochloricum, Hydrastis canadensis, Ricinus communis, sabadilla SPRAY ORAL 20130729 UNAPPROVED HOMEOPATHIC Native Remedies, LLC EPINEPHRINE; CHELIDONIUM MAJUS; PUMPKIN SEED; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; RICINUS COMMUNIS SEED; SCHOENOCAULON OFFICINALE SEED 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-124_b52f36f0-9fed-4191-b7eb-67552b3bf4e4 68703-124 HUMAN OTC DRUG AllergyEase Shellfish and Seafood Adrenalinum, Belladona, Bromium, Carbo animalis, Colchicum autumnale, Colocynthis, Histaminum hydrochloricum, Hydrstis canadensis, Kali carbonicum, Lycopodium clavatum, Mercuris solubilis, Pulsatilla, Urtica urens SPRAY ORAL 20130613 UNAPPROVED HOMEOPATHIC Native Remedies, LLC EPINEPHRINE; ATROPA BELLADONNA; BROMINE; CARBO ANIMALIS; COLCHICUM AUTUMNALE BULB; CITRULLUS COLOCYNTHIS FRUIT PULP; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS; URTICA URENS 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-125_a7e25685-6adb-428b-a81f-75b53bc5f496 68703-125 HUMAN OTC DRUG AllergyEase Mold Arsenicum album, Baptisia tinctoria, Chloramphenicolum, Echinacea, Elais guineensis, Hydrastis canadensis, Mercuris solubilis, Myrrha, Nasturtium aquaticum, Nux vomica, Phosphorus, Phytolacca decandra, Pulsatilla, Ricinus communis, Sepia, Xanthoxylum fraxineum SPRAY ORAL 20130729 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; CHLORAMPHENICOL; ECHINACEA, UNSPECIFIED; ELAEIS GUINEENSIS FRUIT; GOLDENSEAL; MERCURIUS SOLUBILIS; MYRRH; NASTURTIUM OFFICINALE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; RICINUS COMMUNIS SEED; SEPIA OFFICINALIS JUICE; ZANTHOXYLUM AMERICANUM BARK 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-126_c621bb47-5e00-45b5-a3ad-b4dcb2f74906 68703-126 HUMAN OTC DRUG Triple Complex Glucose Control Calc phos, Kali sulph, Nat sulphuricum TINCTURE ORAL 20140617 UNAPPROVED HOMEOPATHIC Native Remedies, LLC TRIBASIC CALCIUM PHOSPHATE; POTASSIUM SULFATE; SODIUM SULFATE 8; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68703-136_1b00a71e-21f6-7392-e054-00144ff88e88 68703-136 HUMAN OTC DRUG Be-Dry Equisetum arv PELLET ORAL 20130828 UNAPPROVED HOMEOPATHIC Silver Star Brands, Inc EQUISETUM ARVENSE TOP 6 [hp_C]/19g N 20181231 68703-137_17f165bf-0cb4-4991-8a79-5800e30dcc7a 68703-137 HUMAN OTC DRUG TremorSoothe Agaricus musc, Mag phos, Stramonium, Tarentula hisp PELLET ORAL 20130828 UNAPPROVED HOMEOPATHIC Native Remedies, LLC AMANITA MUSCARIA FRUITING BODY; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; DATURA STRAMONIUM; LYCOSA TARANTULA 6; 8; 6; 6 [hp_C]/19g; [hp_X]/19g; [hp_C]/19g; [hp_C]/19g N 20181231 68703-138_1b008c1b-5085-3fde-e054-00144ff8d46c 68703-138 HUMAN OTC DRUG BladderWell Apis mel, Cantharis, Equisetum arv, Ferrum phos, Sarsaparilla PELLET ORAL 20130828 UNAPPROVED HOMEOPATHIC Silver Star Brands, Inc APIS MELLIFERA; LYTTA VESICATORIA; EQUISETUM ARVENSE TOP; FERROSOFERRIC PHOSPHATE; SMILAX REGELII ROOT 30; 30; 30; 8; 30 [hp_C]/19g; [hp_C]/19g; [hp_C]/19g; [hp_X]/19g; [hp_C]/19g N 20181231 68703-139_1b00ad9a-1cf1-3f7e-e054-00144ff88e88 68703-139 HUMAN OTC DRUG ProState Relief Chimaphila umb, Clematis virg, Conium, Cubeba, Sabal PELLET ORAL 20130826 UNAPPROVED HOMEOPATHIC Silver Star Brands, Inc CHIMAPHILA UMBELLATA; CLEMATIS VIRGINIANA TOP; CONIUM MACULATUM FLOWERING TOP; PIPER CUBEBA FRUIT; SAW PALMETTO 6; 6; 6; 6; 6 [hp_C]/19g; [hp_C]/19g; [hp_C]/19g; [hp_C]/19g; [hp_C]/19g N 20181231 68703-140_27bf8d0c-610b-4a84-8f70-1d310c5751f5 68703-140 HUMAN OTC DRUG SocialFear Relief Cacao, Gelsemium, Graphites PELLET ORAL 20130820 UNAPPROVED HOMEOPATHIC Native Remedies, LLC COCOA; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE 30; 30; 30 [hp_C]/19g; [hp_C]/19g; [hp_C]/19g N 20181231 68703-151_1b021cdc-d5bf-15d5-e054-00144ff8d46c 68703-151 HUMAN OTC DRUG EyeClear Pro Calc carb, Calc fluor, Casuticum, Cineraria, Euphrasia, Napthalinum, Nat mur, Phos, Quassia, Silicea SPRAY ORAL 20140712 UNAPPROVED HOMEOPATHIC Silver Star Brands, Inc OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CAUSTICUM; JACOBAEA MARITIMA; EUPHRASIA STRICTA; NAPHTHALENE; SODIUM CHLORIDE; PHOSPHORUS; QUASSIA AMARA WOOD; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-153_89aa506d-64d5-4c44-8ef1-0f3a2d3ca183 68703-153 HUMAN OTC DRUG SciatiGon-M Aconitum napellus, Berberis vulgaris, Chamomilla, Colocynthis, Magnesia phosphorica, Rhus toxicodendron TINCTURE ORAL 20141207 UNAPPROVED HOMEOPATHIC Native Remedies, LLC ACONITUM NAPELLUS; BERBERIS VULGARIS ROOT BARK; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF 6; 3; 2; 30; 8; 30 [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 68703-200_28d89fca-81eb-2f31-e054-00144ff88e88 68703-200 HUMAN OTC DRUG Healthful Naturals Mole Remover Carbo veg, Graphites, Lycopodium,Phytolacca, Thuja occ LIQUID TOPICAL 20151117 UNAPPROVED HOMEOPATHIC Silver Star Brands CARBO ANIMALIS; GRAPHITE; PHYTOLACCA AMERICANA ROOT; LYCOPODIUM CLAVATUM SPORE; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL N 20181231 68703-201_21eae767-6b4c-528a-e054-00144ff8d46c 68703-201 HUMAN OTC DRUG Healthful Naturals Scar Remover arnica montana, calcarea fluorica, calcarea phosphorica, calendula officinalis, graphites, hydrofluoricum acidum, phytolacca decandra, sabina, silicea, thiosinaminum, thuja occidentalis liquid LIQUID TOPICAL 20151028 UNAPPROVED HOMEOPATHIC Silver Star Brands TRIBASIC CALCIUM PHOSPHATE; GRAPHITE; SILICON DIOXIDE; ALLYLTHIOUREA; HYDROFLUORIC ACID; ARNICA MONTANA; CALCIUM FLUORIDE; CALENDULA OFFICINALIS FLOWERING TOP; PHYTOLACCA AMERICANA ROOT; JUNIPERUS SABINA LEAFY TWIG; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL N 20181231 68703-202_21e97243-e582-6b09-e054-00144ff8d46c 68703-202 HUMAN OTC DRUG Healthful Naturals Wart Remover Antimon crud, Causticum, Dulcamara, Kali mur, Nitricum ac, Sabina, Staphysag, Sulphur, Thuja occ LIQUID TOPICAL 20151107 UNAPPROVED HOMEOPATHIC Silver Star Brands ANTIMONY TRISULFIDE; CAUSTICUM; SOLANUM DULCAMARA TOP; NITRIC ACID; JUNIPERUS SABINA LEAFY TWIG; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL N 20181231 68703-203_228b9ce8-fc80-0381-e054-00144ff8d46c 68703-203 HUMAN OTC DRUG SciatiSoothe Aconitum napellus, Berberis vulgaris, Chamomilla, Colocynthis, Magnesia phosphorica, Rhus tox SPRAY ORAL 20160215 UNAPPROVED HOMEOPATHIC Silver Star Brands MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; MATRICARIA RECUTITA; ACONITUM NAPELLUS; BERBERIS VULGARIS ROOT BARK; CITRULLUS COLOCYNTHIS FRUIT PULP 8; 30; 2; 6; 3; 30 [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL N 20181231 68703-204_243449e3-cd31-612c-e054-00144ff88e88 68703-204 HUMAN OTC DRUG DizziFree Bryonia, Cocculus, Gelsemium, Lobelia inf SPRAY ORAL 20160215 UNAPPROVED HOMEOPATHIC Silver Star Brands GELSEMIUM SEMPERVIRENS ROOT; BRYONIA ALBA ROOT; ANAMIRTA COCCULUS SEED; LOBELIA INFLATA 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-205_24359554-9e84-052c-e054-00144ff8d46c 68703-205 HUMAN OTC DRUG ShinglEase Arsenicum album, Capsicum annuum, Mentha piperita, Mezereum, Natrum muriaticum, Ranunculus bulbosus, Rhus tox SPRAY ORAL 20160215 UNAPPROVED HOMEOPATHIC Silver Star Brands RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF; ARSENIC TRIOXIDE; CAPSICUM; MENTHA PIPERITA; SODIUM CHLORIDE; DAPHNE MEZEREUM BARK 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-206_24363142-6458-1cfe-e054-00144ff8d46c 68703-206 HUMAN OTC DRUG Leg Cramp Support Calcarea carbonica, Cuprum metallicum, Gnaphalium polycephalum, Hyoscyamus niger, Ingatia amara, Magnesia phosphorica, Nux comica, Passiflora incarnata, Platinum metallicum, Plumbum metallicum, Secale cornutum, Strychninum SPRAY ORAL 20160215 UNAPPROVED HOMEOPATHIC Silver Star Brands PSEUDOGNAPHALIUM OBTUSIFOLIUM; COPPER; PLATINUM; CLAVICEPS PURPUREA SCLEROTIUM; STRYCHNOS IGNATII SEED; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; LEAD; STRYCHNINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; HYOSCYAMUS NIGER 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-207_2433b747-0ba7-39fb-e054-00144ff8d46c 68703-207 HUMAN OTC DRUG Bladder Control Calc fluor, Equisetum arv, Nat phos, Nat sulphuricum, Pulsatilla SPRAY ORAL 20160215 UNAPPROVED HOMEOPATHIC Silver Star Brands SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; EQUISETUM ARVENSE TOP; PULSATILLA VULGARIS; SODIUM SULFATE; CALCIUM FLUORIDE 6; 3; 3; 6; 6 [hp_C]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-208_243661ca-13d1-32e1-e054-00144ff88e88 68703-208 HUMAN OTC DRUG VisiClear Calc carb, Calc fluor, Causticum, Cineraria, Euphrasia, Naphthalinum, Nat mur, Phos, Quassia, Silicea SPRAY ORAL 20160215 UNAPPROVED HOMEOPATHIC Silver Star Brands JACOBAEA MARITIMA; EUPHRASIA STRICTA; NAPHTHALENE; CAUSTICUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; SODIUM CHLORIDE; PHOSPHORUS; QUASSIA AMARA WOOD; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 68703-213_5d65c997-f5dd-4dee-e053-2a91aa0ac319 68703-213 HUMAN OTC DRUG Shingles Remedy Croton tiglium, Natrum muriaticum, Plantago major, Rhus tox, Sarsaparilla GEL TOPICAL 20171211 UNAPPROVED HOMEOPATHIC Silver Star Brands CROTON TIGLIUM SEED; TOXICODENDRON RADICANS LEAF; SMILAX REGELII ROOT; PLANTAGO MAJOR; SODIUM CHLORIDE 30; 30; 30; 30; 30 [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g N 20181231 68703-214_5de32504-40cf-dfaf-e053-2991aa0a1526 68703-214 HUMAN OTC DRUG Eczema Remedy Carbolicum acidum, Fagopyrum esculentum, hydrastis canadensis, Hydrocotyle asiatica, Juglans regia, Vinca minor LOTION TOPICAL 20171211 UNAPPROVED HOMEOPATHIC Silver Star Brands FAGOPYRUM ESCULENTUM; JUGLANS REGIA LEAF; VINCA MINOR; HYDRASTIS CANADENSIS WHOLE; CENTELLA ASIATICA; PHENOL 30; 30; 30; 30; 30; 30 [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g N 20181231 68703-215_5e94e5f1-52b2-e564-e053-2a91aa0a29e8 68703-215 HUMAN OTC DRUG Neck Back Sciatic Remedy Phytolacca Decandra, Gnaphalium Polycephalum, Hypericum Perforatum, Colocynthis, Gelsemium Sempervirens, Guaiacum, Ledum Palustre, Conium Maculatum LOTION TOPICAL 20171211 UNAPPROVED HOMEOPATHIC Silver Star Brands PHYTOLACCA AMERICANA ROOT; HYPERICUM PERFORATUM; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; CITRULLUS COLOCYNTHIS FRUIT; GUAIACUM OFFICINALE RESIN; LEDUM PALUSTRE TWIG; PSEUDOGNAPHALIUM OBTUSIFOLIUM 1; 3; 30; 6; 6; 6; 6; 3 [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g; [hp_X]/113g N 20181231 68703-251_2ea6b6bd-0db2-603a-e054-00144ff8d46c 68703-251 HUMAN OTC DRUG ShingleSoothe Apis mellifica, Arsenicum album, Magnesia phosphorica, Natrum muriaticum, Rhus tox, Urtica urens TINCTURE ORAL 20160502 UNAPPROVED HOMEOPATHIC Silver Star Brands TOXICODENDRON RADICANS LEAF; URTICA URENS; APIS MELLIFERA; ARSENIC TRIOXIDE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE 30; 30; 6; 30; 6; 6 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-252_2eb93d7c-3310-4b93-e054-00144ff88e88 68703-252 HUMAN OTC DRUG BrightSpark Arg nit, Arsenicum iod, Hyoscyamus, Veratrum alb SPRAY ORAL 20160620 UNAPPROVED HOMEOPATHIC Silver Star Brands SILVER NITRATE; VERATRUM ALBUM ROOT; ARSENIC TRIIODIDE; HYOSCYAMUS NIGER 6; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-253_2eba4caa-fd9c-482d-e054-00144ff8d46c 68703-253 HUMAN OTC DRUG VertiFree Bryonia, Cocculus, Gelsemium, Lobelia inf SPRAY ORAL 20160620 UNAPPROVED HOMEOPATHIC Silver Star Brands BRYONIA ALBA ROOT; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; LOBELIA INFLATA 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-254_2ebae3f5-6d31-2d29-e054-00144ff88e88 68703-254 HUMAN OTC DRUG TremorSoothe Agaricus musc, Mag phos, Stramonium, Tarentula hisp SPRAY ORAL 20160620 UNAPPROVED HOMEOPATHIC Silver Star Brands DATURA STRAMONIUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; AMANITA MUSCARIA VAR. MUSCARIA; LYCOSA TARANTULA 6; 8; 6; 6 [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-255_2f6f6269-c189-400c-e054-00144ff88e88 68703-255 HUMAN OTC DRUG NeuropathEase Agaricus muscarius, Arsenicum album, Hypericum perforatum, Phosphorus, Silicea LIQUID ORAL 20160711 UNAPPROVED HOMEOPATHIC Silver Star Brands AMANITA MUSCARIA FRUITING BODY; HYPERICUM PERFORATUM; SILICON DIOXIDE; PHOSPHORUS; ARSENIC TRIOXIDE 30; 30; 6; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-256_41487ca2-fcef-0ee3-e054-00144ff88e88 68703-256 HUMAN OTC DRUG Sweat-Less Arg nit, Castoreum, Humulus, Iodum, Kali phos, Nat mur LIQUID ORAL 20160607 UNAPPROVED HOMEOPATHIC Silver Star Brands SILVER NITRATE; CASTOR CANADENSIS SCENT GLAND SECRETION; HOPS; POTASSIUM PHOSPHATE, DIBASIC; IODINE; SODIUM CHLORIDE 6; 30; 30; 30; 30; 6 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL E 20171231 68703-257_4148cf33-e10a-19d8-e054-00144ff88e88 68703-257 HUMAN OTC DRUG Epi-Still-M Cicuta virosa, Cuprum metallicum, Ignatia amara, Passiflora incamata, Scutellaria lateriflora, Zincum metallicum LIQUID ORAL 20160801 UNAPPROVED HOMEOPATHIC Silver Star Brands PASSIFLORA INCARNATA FLOWER; SCUTELLARIA LATERIFLORA; ZINC; COPPER; CICUTA VIROSA ROOT; STRYCHNOS IGNATII SEED 2; 2; 8; 30; 30; 8 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL N 20181231 68703-258_34c9dacf-3d30-6343-e054-00144ff88e88 68703-258 HUMAN OTC DRUG Behavior-Rite Anacard or, Cina, Chamomilla, Thea sinensis, Viola tric SPRAY ORAL 20160808 UNAPPROVED HOMEOPATHIC Silver Star Brands ARTEMISIA CINA FLOWER; SEMECARPUS ANACARDIUM JUICE; MATRICARIA RECUTITA; VIOLA TRICOLOR; CAMELLIA SINENSIS FLOWER 30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-259_352dd690-0cef-02a4-e054-00144ff88e88 68703-259 HUMAN OTC DRUG Well-Ex Arsenicum alb, Graphites, Hepar sulph calc, Radium brom, Viola tric SPRAY ORAL 20160912 UNAPPROVED HOMEOPATHIC Silver Star Brands RADIUM BROMIDE; ARSENIC TRIOXIDE; CALCIUM SULFIDE; GRAPHITE; VIOLA TRICOLOR 30; 6; 6; 6; 6 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-260_353c989f-2c05-6a51-e054-00144ff88e88 68703-260 HUMAN OTC DRUG SlumberPax Cinchona, Coffea cruda, Kali phos, Nux vom, Staphysag SPRAY ORAL 20160912 UNAPPROVED HOMEOPATHIC Silver Star Brands CINCHONA OFFICINALIS BARK; COFFEA ARABICA FRUIT; POTASSIUM PHOSPHATE, DIBASIC; STRYCHNOS NUX-VOMICA SEED; DELPHINIUM STAPHISAGRIA SEED 30; 30; 6; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-261_353c989f-2c0e-6a51-e054-00144ff88e88 68703-261 HUMAN OTC DRUG NativeRemedies CaffAddict Bryonia, Chamomilla, Mag phos, Nux vom, Pulsatilla SPRAY ORAL 20160912 UNAPPROVED HOMEOPATHIC Silver Star Brands BRYONIA ALBA ROOT; MATRICARIA CHAMOMILLA FLOWERING TOP OIL; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS 30; 30; 6; 30; 6 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-262_3f28a4c7-a6c4-363d-e054-00144ff8d46c 68703-262 HUMAN OTC DRUG RespoSoothe Aconitum napellus, Arsenicum album, Bryonia, Cuprum metallicum, Phosphorus SPRAY ORAL 20161024 UNAPPROVED HOMEOPATHIC Silver Star Brands ACONITUM NAPELLUS; ARSENIC TRIOXIDE; PHOSPHORUS; COPPER; BRYONIA ALBA ROOT 30; 30; 6; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-263_3f29faae-66c3-1888-e054-00144ff88e88 68703-263 HUMAN OTC DRUG Tranqui-Bladder Causticum, Equisetum hyemale, Lilium tigrinum, Nux vomica, Thuja occidentalis SPRAY ORAL 20161024 UNAPPROVED HOMEOPATHIC Silver Star Brands LILIUM LANCIFOLIUM WHOLE; STRYCHNOS NUX-VOMICA WHOLE; THUJA OCCIDENTALIS WHOLE; EQUISETUM HYEMALE; CAUSTICUM 30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-264_3f2a4d6b-e3d0-22a4-e054-00144ff88e88 68703-264 HUMAN OTC DRUG DigestoCalm Argentum nitricum, Calcarea phosphorica, Colcynthis, Ferrum phosphoricum, Nux vomica SPRAY ORAL 20161024 UNAPPROVED HOMEOPATHIC Silver Star Brands STRYCHNOS NUX-VOMICA WHOLE; CALCIUM PHOSPHATE; CITRULLUS COLOCYNTHIS WHOLE; SILVER NITRATE; FERROSOFERRIC PHOSPHATE 6; 6; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-267_41493f5b-e176-2e2f-e054-00144ff88e88 68703-267 HUMAN OTC DRUG Enliven Arg nit, Ferrum met, Phos, Phosphoricum ac, Uranium nitricum SPRAY ORAL 20161121 UNAPPROVED HOMEOPATHIC Silver Star Brands URANYL NITRATE; PHOSPHORIC ACID; PHOSPHORUS; IRON DEXTRAN; SILVER NITRATE 30; 30; 30; 30; 6 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-268_4185b63d-fb2b-694c-e054-00144ff8d46c 68703-268 HUMAN OTC DRUG Junior Moves Anacard or, Bryonia, Mag mur, Nat mur, Plumb met SPRAY ORAL 20161121 UNAPPROVED HOMEOPATHIC Silver Star Brands MAGNESIUM CHLORIDE; BRYONIA ALBA ROOT; SODIUM CHLORIDE; LEAD; SEMECARPUS ANACARDIUM JUICE 30; 30; 6; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-269_4186254d-af76-2697-e054-00144ff88e88 68703-269 HUMAN OTC DRUG Boil Soothe Arnica, Calc sulph, Hepar sulph calc, Merc solub, Silicea SPRAY ORAL 20161121 UNAPPROVED HOMEOPATHIC Silver Star Brands CALCIUM SULFATE; CALCIUM SULFIDE; ARNICA MONTANA; MERCURIUS SOLUBILIS; SILICON DIOXIDE 6; 30; 30; 30; 6 [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL N 20181231 68703-273_47e1235a-485f-3683-e054-00144ff8d46c 68703-273 HUMAN OTC DRUG MediCrave Arnica, Caladium seguinum, Lobelia inf, Petroleum, Tabacum SPRAY ORAL 20170206 UNAPPROVED HOMEOPATHIC Silver Star Brands ARNICA MONTANA; LIQUID PETROLEUM; DIEFFENBACHIA SEGUINE; LOBELIA INFLATA; TOBACCO LEAF 30; 30; 6; 30; 12 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL N 20181231 68703-274_439023f1-5a86-3160-e054-00144ff88e88 68703-274 HUMAN OTC DRUG QuitCalm Arsenicum iodatum, Bromium, Chamomilla, Nux vomica, Staphysagria SPRAY ORAL 20161219 UNAPPROVED HOMEOPATHIC Silver Star Brands STRYCHNOS NUX-VOMICA SEED; DELPHINIUM STAPHISAGRIA SEED; MATRICARIA RECUTITA; ARSENIC TRIIODIDE; BROMINE 6; 30; 30; 30; 6 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-275_47e29360-c79e-0359-e054-00144ff8d46c 68703-275 HUMAN OTC DRUG HypoSlim Calcarea carbonica, Ferrum metallicum, Graphites, Lycopodium clavatum, Spongia tosta SPRAY ORAL 20170206 UNAPPROVED HOMEOPATHIC Silver Star Brands SPONGIA OFFICINALIS WHOLE; CALCIUM CARBONATE; IRON DEXTRAN; GRAPHITE; LYCOPODIUM CLAVATUM WHOLE 30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-276_47e33f85-6345-052f-e054-00144ff8d46c 68703-276 HUMAN OTC DRUG HormoSlim Calcarea carbonica, Nux vomica, Sepia, Spongia tosta, Sulphur SPRAY ORAL 20170206 UNAPPROVED HOMEOPATHIC Silver Star Brands CALCIUM CARBONATE; SEPIA OFFICINALIS WHOLE; SPONGIA OFFICINALIS WHOLE; STRYCHNOS NUX-VOMICA WHOLE; SULFUR 30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-277_47e38f0b-b72d-5062-e054-00144ff88e88 68703-277 HUMAN OTC DRUG EmotiSlim Ignatia amara, Kali phosphoricum, Lycopodium clavatum, Natrum muriaticum, Radium bromatum SPRAY ORAL 20170206 UNAPPROVED HOMEOPATHIC Silver Star Brands STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; LYCOPODIUM CLAVATUM WHOLE; SODIUM CHLORIDE; RADIUM BROMIDE 30; 6; 30; 6; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-283_4d11a65e-6967-0727-e054-00144ff88e88 68703-283 HUMAN OTC DRUG EarStill Calc fluor, Carboneum sulph, Chininum sulph, Mang met, Salicylicum ac SPRAY ORAL 20170417 UNAPPROVED HOMEOPATHIC Silver Star Brands CALCIUM FLUORIDE; CARBON DISULFIDE; QUININE SULFATE; MANGANESE; SALICYLIC ACID 30; 6; 6; 6; 6 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-284_4d118707-5abe-5806-e054-00144ff8d46c 68703-284 HUMAN OTC DRUG Liver Boost Aresnicum alb, Carbo veg, Carduus mar, Chelidonium maj, Nux vom SPRAY ORAL 20170417 UNAPPROVED HOMEOPATHIC Silver Star Brands ARSENIC TRIOXIDE; MILK THISTLE; STRYCHNOS NUX-VOMICA SEED; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS 30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-285_4d118707-5ac6-5806-e054-00144ff8d46c 68703-285 HUMAN OTC DRUG Hair Growth Promote Arsenicum alb, Hydrofluoricum ac, Lycopodium, Scutellaria, Sepia SPRAY ORAL 20170424 UNAPPROVED HOMEOPATHIC Silver Star Brands ARSENIC TRIOXIDE; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; HYDROFLUORIC ACID; LYCOPODIUM CLAVATUM SPORE 6; 30; 6; 30; 6 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-286_4d11a65e-6969-0727-e054-00144ff88e88 68703-286 HUMAN OTC DRUG Migo-Ease Aconitum nap, Lycopodium, Nat mur, Nux vom, Pulsatilla SPRAY ORAL 20170417 UNAPPROVED HOMEOPATHIC Silver Star Brands ACONITUM NAPELLUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; LYCOPODIUM CLAVATUM SPORE 30; 6; 6; 6; 6 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-287_4d118707-5ac2-5806-e054-00144ff8d46c 68703-287 HUMAN OTC DRUG Metabo-Boost Calc carb, Lycopodium, Nat mur, Nux vom, Sepia SPRAY ORAL 20170417 UNAPPROVED HOMEOPATHIC Silver Star Brands LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SEPIA OFFICINALIS JUICE; CALCIUM CARBONATE 30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-288_4d11cc46-394d-1561-e054-00144ff8d46c 68703-288 HUMAN OTC DRUG XY Health Pro Agnus, Conium, Lycopodium, Sabal, Sulphur SPRAY ORAL 20170424 UNAPPROVED HOMEOPATHIC Silver Star Brands CHASTE TREE; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; SULFUR; SAW PALMETTO 30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-289_4d11a65e-696b-0727-e054-00144ff88e88 68703-289 HUMAN OTC DRUG XX Health Pro Lachesis, Nat mur, Pulsatilla, Sepia, Sulphur SPRAY ORAL 20170417 UNAPPROVED HOMEOPATHIC Silver Star Brands LACHESIS MUTA VENOM; SODIUM CHLORIDE; PULSATILLA VULGARIS; SULFUR; SEPIA OFFICINALIS JUICE 30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-292_4d118707-5ac0-5806-e054-00144ff8d46c 68703-292 HUMAN OTC DRUG BP Assist Aceticum ac, Cinchona, Gelsemium, Naja, Silicea SPRAY ORAL 20170417 UNAPPROVED HOMEOPATHIC Silver Star Brands ACETIC ACID; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; NAJA NAJA VENOM; SILICON DIOXIDE 30; 30; 6; 6; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-294_4d118707-5ac4-5806-e054-00144ff8d46c 68703-294 HUMAN OTC DRUG Twitch-Less Cina, Phos, Rhus tox, Tarentula hisp, Zinc met SPRAY ORAL 20170417 UNAPPROVED HOMEOPATHIC Silver Star Brands ZINC; LYCOSA TARANTULA; PHOSPHORUS; ARTEMISIA CINA FLOWER; TOXICODENDRON RADICANS LEAF 30; 30; 30; 6; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-295_4d11cc46-3938-1561-e054-00144ff8d46c 68703-295 HUMAN OTC DRUG PMS-Away Cacao, Calcarea carbonica, Cimicifuga racemosa, Natrum muriaticum, Pulsatilla SPRAY ORAL 20170417 UNAPPROVED HOMEOPATHIC Silver Star Brands BLACK COHOSH; PULSATILLA VULGARIS; COCOA; CALCIUM CARBONATE; SODIUM CHLORIDE 6; 6; 6; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-296_4d11a65e-696d-0727-e054-00144ff88e88 68703-296 HUMAN OTC DRUG FlowCalm Caulophyllum thalictroides, Cimicifuga racemosa, Ipecacuanha, Sepia, Vinca minor SPRAY ORAL 20170417 UNAPPROVED HOMEOPATHIC Silver Star Brands BLACK COHOSH; IPECAC; SEPIA OFFICINALIS JUICE; CAULOPHYLLUM THALICTROIDES ROOT; VINCA MINOR 30; 6; 30; 6; 6 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-297_4d11a65e-696f-0727-e054-00144ff88e88 68703-297 HUMAN OTC DRUG Dysmenorrex Chamomilla, Magnesia phosphorica, Murex purpurea, Platinum metallicum, Viburnum opulus SPRAY ORAL 20170508 UNAPPROVED HOMEOPATHIC Silver Star Brands VIBURNUM OPULUS BARK; PLATINUM; MATRICARIA RECUTITA; MAGNESIUM PHOSPHATE, DIBASIC; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE 6; 6; 6; 6; 6 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-298_4d11cc46-3944-1561-e054-00144ff8d46c 68703-298 HUMAN OTC DRUG ThyroCalm Argentum nitricum, Iodium, Kali phosphoricum, Lac caninum, Lachesis mutus SPRAY ORAL 20170424 UNAPPROVED HOMEOPATHIC Silver Star Brands SILVER NITRATE; IODINE; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; CANIS LUPUS FAMILIARIS MILK; LACHESIS MUTA VENOM 30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-299_4d11cc46-3946-1561-e054-00144ff8d46c 68703-299 HUMAN OTC DRUG ThyroPromote Alumina, Calcarea carbonica, Ferrum metallicum, Graphites, Sepia SPRAY ORAL 20170424 UNAPPROVED HOMEOPATHIC Silver Star Brands CALCIUM CARBONATE; SEPIA OFFICINALIS JUICE; ALUMINUM OXIDE; IRON; GRAPHITE 30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-300_4d11cc46-394b-1561-e054-00144ff8d46c 68703-300 HUMAN OTC DRUG Bio-Cheer Anacardium orientale, Graphites, Lilium tigrinum, Sepia, Staphysagria SPRAY ORAL 20170424 UNAPPROVED HOMEOPATHIC Silver Star Brands SEMECARPUS ANACARDIUM JUICE; GRAPHITE; SEPIA OFFICINALIS JUICE; DELPHINIUM STAPHISAGRIA SEED; LILIUM LANCIFOLIUM BULB 30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-301_4d11cc46-393a-1561-e054-00144ff8d46c 68703-301 HUMAN OTC DRUG Sleepy Jr Chamomilla, Cina, Chinchona officinalis, Coffea cruda, Nux vomica SPRAY ORAL 20170424 UNAPPROVED HOMEOPATHIC Silver Star Brands CINCHONA OFFICINALIS BARK; STRYCHNOS NUX-VOMICA SEED; MATRICARIA RECUTITA; COFFEA ARABICA FRUIT; ARTEMISIA CINA FLOWER 30; 30; 6; 6; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-302_579fffea-8c47-0a11-e053-2a91aa0a9135 68703-302 HUMAN OTC DRUG EndometrEase Cimicifuga racemosa, Ipecacuanha, Lilium tigrinum, Pulsatilla, Sulphur SPRAY ORAL 20170605 UNAPPROVED HOMEOPATHIC Silver Star Brands IPECAC; SULFUR; ANEMONE PULSATILLA; BLACK COHOSH; LILIUM LANCIFOLIUM WHOLE FLOWERING 30; 30; 30; 30; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68703-303_57a0479a-d599-dd91-e053-2991aa0a77a4 68703-303 HUMAN OTC DRUG GasTamer S.O.S. Antimon crud, Carbo veg, Lycopodium, Silicea, Sulphur SPRAY ORAL 20170816 UNAPPROVED HOMEOPATHIC Silver Star Brands ACTIVATED CHARCOAL; LYCOPODIUM CLAVATUM SPORE; ANTIMONY TRISULFIDE; SULFUR; SILICON DIOXIDE 6; 6; 30; 6; 30 [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL N 20181231 68712-020_0e33cbf4-abba-49e1-9ade-8c3e4a7358e5 68712-020 HUMAN PRESCRIPTION DRUG Umecta Mousse Urea Urea Foam AEROSOL, FOAM TOPICAL 20070901 UNAPPROVED DRUG OTHER Innocutis Holdings LLC UREA 400 mg/g N 20181231 68712-027_b367ac0c-2c88-4c37-809b-da4297a47cc6 68712-027 HUMAN PRESCRIPTION DRUG CNL8 Ciclopirox SOLUTION TOPICAL 20081031 ANDA ANDA078270 Innocutis Holdings LLC CICLOPIROX 2.28 g/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] E 20171231 68712-049_4d76b99b-3aba-36b3-e054-00144ff88e88 68712-049 HUMAN PRESCRIPTION DRUG Sitavig Acyclovir TABLET, DELAYED RELEASE BUCCAL 20140320 NDA NDA203791 Cipher Pharmaceuticals US LLC ACYCLOVIR 50 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68715-084_376f163e-9981-41a9-8640-ae9419c370dd 68715-084 HUMAN OTC DRUG Derma Doctor Born to be Mild Cleanser Pyrithione Zinc GEL TOPICAL 20051201 OTC MONOGRAPH FINAL part358H DERMAdoctor PYRITHIONE ZINC 2 g/100mL N 20181231 68715-291_94e2bb79-513b-4d46-be46-70be25b04369 68715-291 HUMAN OTC DRUG Derma Doctor Calm Cool and Corrected Pyrithione Zinc GEL TOPICAL 20051201 OTC MONOGRAPH FINAL part358H DERMAdoctor PYRITHIONE ZINC 2 g/100mL N 20181231 68723-305_9ad744ac-5cdd-4b2c-af3e-4ceee3810186 68723-305 HUMAN OTC DRUG Benzoyl Peroxide 5% Gel Benzoyl Peroxide GEL TOPICAL 20170718 OTC MONOGRAPH FINAL part333D Axia Medical Solutions, LLC BENZOYL PEROXIDE 50 mg/1000mg N 20181231 68723-306_681cc3eb-5f80-4c84-88fc-f19688b748b8 68723-306 HUMAN OTC DRUG Benzoyl Peroxide 10% Gel Benzoyl Peroxide GEL TOPICAL 20141001 OTC MONOGRAPH FINAL part333D Axia Medical Solutions, LLC BENZOYL PEROXIDE 100 mg/g N 20181231 68723-330_a1a0a019-2fa2-43d2-a47d-67d78054e2e2 68723-330 HUMAN OTC DRUG Dermesse Sunscreen SPF30 Octinoxate, Titanium Dioxide LOTION TOPICAL 20120401 OTC MONOGRAPH FINAL part352 Axia Medical Solutions, LLC OCTINOXATE; TITANIUM DIOXIDE 70; 20 mg/g; mg/g N 20181231 68723-331_7c13071e-5121-4144-951c-0d889e51359f 68723-331 HUMAN OTC DRUG Dermesse Sunscreen SPF30 Medium Tint Octinoxate, Zinc Oxide LOTION TOPICAL 20150501 OTC MONOGRAPH FINAL part352 Axia Medical Solutions, LLC OCTINOXATE; ZINC OXIDE 75; 70 mg/g; mg/g N 20181231 68726-068_f43559fd-c106-4ef1-8150-021a46baa5d3 68726-068 HUMAN OTC DRUG PCA SKIN ACNE SALICYLIC ACID GEL TOPICAL 20040501 OTC MONOGRAPH FINAL part333D Physicians Care Alliance dba PCA Skin SALICYLIC ACID 2 g/100mL N 20181231 68726-167_a755dcbf-6024-4052-af08-079d989a0054 68726-167 HUMAN OTC DRUG PCA SKIN Body Hydrator SPF30 Zinc Oxide and Octinoxate LOTION TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Physicians Care Alliance, LLC DBA PCA SKIN ZINC OXIDE; OCTINOXATE 9.8; 7.5 g/100g; g/100g N 20181231 68726-168_d7269730-a2c1-4d23-9b76-cc5ca409c555 68726-168 HUMAN OTC DRUG PCA SKIN BPO Cleanser Benzoyl Peroxide GEL TOPICAL 20100401 OTC MONOGRAPH FINAL part333D Physicians Care Alliance DBA PCA SKIN BENZOYL PEROXIDE 5 g/100mL N 20181231 68726-169_f6bf6d53-8297-4307-84d5-bc918564a987 68726-169 HUMAN OTC DRUG PCA SKIN Acne Benzoyl Perozide CREAM TOPICAL 20100401 OTC MONOGRAPH FINAL part333D Physicians Care Alliance DBA PCA SKIN BENZOYL PEROXIDE 5 g/100g N 20181231 68726-301_332c8c8b-6db5-4906-99cb-e51f4a838dfc 68726-301 HUMAN OTC DRUG PCA SKIN Intensive Clarity Treatment SALICYLIC ACID GEL TOPICAL 20160701 OTC MONOGRAPH FINAL part333D Physicians Care Alliance dba PCA Skin SALICYLIC ACID 2 g/100g N 20181231 68726-335_cb2ce979-7d62-4545-ac07-290c18d037b4 68726-335 HUMAN OTC DRUG PCA Skin Intensive Pigment Eraser Pyrithione Zinc GEL TOPICAL 20170701 OTC MONOGRAPH FINAL part358H PCA Skin PYRITHIONE ZINC 2 g/100g N 20181231 68727-100_92337a84-647c-48dc-a8dd-f86ba420b8ca 68727-100 HUMAN PRESCRIPTION DRUG Xyrem sodium oxybate SOLUTION ORAL 20020717 NDA NDA021196 Jazz Pharmaceuticals, Inc. SODIUM OXYBATE .5 g/mL Central Nervous System Depressant [EPC],Central Nervous System Depression [PE],Decreased Central Nervous System Organized Electrical Activity [PE] CIII N 20181231 68727-600_39adabbf-a561-477c-b52e-5446c9597647 68727-600 HUMAN PRESCRIPTION DRUG Luvox CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE ORAL 20080228 NDA NDA022033 Jazz Pharmaceuticals, Inc. FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68727-601_39adabbf-a561-477c-b52e-5446c9597647 68727-601 HUMAN PRESCRIPTION DRUG Luvox CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE ORAL 20080228 NDA NDA022033 Jazz Pharmaceuticals, Inc. FLUVOXAMINE MALEATE 150 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68727-745_238f70d2-26f4-44c8-82fc-9aac10466f75 68727-745 HUMAN PRESCRIPTION DRUG VYXEOS (daunorubicin and cytarabine) liposome INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INTRAVENOUS 20170803 NDA NDA209401 Jazz Pharmaceuticals, Inc. CYTARABINE; DAUNORUBICIN 100; 44 mg/20mL; mg/20mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA],Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 68727-800_c64466c2-3e9e-4470-96b7-0b25c3f0648f 68727-800 HUMAN PRESCRIPTION DRUG DEFITELIO defibrotide sodium INJECTION, SOLUTION INTRAVENOUS 20160330 NDA NDA208114 Jazz Pharmaceuticals, Inc. DEFIBROTIDE SODIUM 80 mg/mL N 20181231 68737-223_432a298f-3538-4980-9421-c9a75f57ff77 68737-223 HUMAN OTC DRUG Allergy Get Relief Diphenhydramine Hydrochloride TABLET ORAL 20120630 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 68737-224_8bf7e7ac-aa38-4ba5-8c4f-55d15e27f7b0 68737-224 HUMAN OTC DRUG PM Get Relief Acetaminophen and Diphenhydramine Hydrochloride TABLET ORAL 20120630 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 68737-225_2596b3d9-3b6c-4325-9a9d-dfe4bb3c3e91 68737-225 HUMAN OTC DRUG ConRx Allergy Sinus Multi-Symptoms Acetaminophen, Chlorpheniramine maleate, and Phenylephrine Hydrochloride TABLET ORAL 20120711 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 E 20171231 68737-226_896dcc9f-86b2-4fbd-8bf4-22d7c15b43a2 68737-226 HUMAN OTC DRUG ConRx Sinus Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20120711 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 E 20171231 68737-227_027ea3a1-9733-468e-9ae5-872c11381309 68737-227 HUMAN OTC DRUG ConRx Cold Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20120710 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 68737-229_c4310dbf-b2cf-4d72-a63a-11b34b148aef 68737-229 HUMAN OTC DRUG ConRx Alert Caffeine TABLET ORAL 20130215 OTC MONOGRAPH FINAL part340 Eagle Distributors,Inc. CAFFEINE 200 mg/1 E 20171231 68737-230_ba486804-de1f-4762-959a-42aa87259b98 68737-230 HUMAN OTC DRUG ConRx Allergy Diphenhydramine Hydrochloride TABLET ORAL 20130215 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 68737-231_2eee76ce-e881-4ca7-b7d5-2dbf60dbff77 68737-231 HUMAN OTC DRUG ConRx Allergy Sinus Acetaminophen, Chlorpheniramine maleate, and Phenylephrine Hydrochloride TABLET ORAL 20130215 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 E 20171231 68737-232_fe6658d7-6785-4f88-b192-36ae6f8e11ca 68737-232 HUMAN OTC DRUG ConRx Cold Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20130215 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 68737-233_4be86d0c-da24-4a2a-ab46-43c657d1d986 68737-233 HUMAN OTC DRUG ConRx Extra Strength Acetaminophen TABLET ORAL 20130215 OTC MONOGRAPH NOT FINAL part343 Eagle Distributors,Inc. ACETAMINOPHEN 500 mg/1 E 20171231 68737-234_a4c899e8-155f-4dd0-a8a5-002aba7230d6 68737-234 HUMAN OTC DRUG ConRx pain Reliever Acetaminophen, Aspirin, and Caffeine TABLET ORAL 20130215 OTC MONOGRAPH FINAL part343 Eagle Distributors,Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 E 20171231 68737-235_e0d78b48-3e06-408b-ac88-3461cf878645 68737-235 HUMAN OTC DRUG ConRx PM Acetaminophen and Diphenhydramine Hydrochloride TABLET ORAL 20130215 OTC MONOGRAPH FINAL part338 Eagle Distributors,Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 68737-236_c46d5213-7c5b-4435-9fac-c2323e6e1699 68737-236 HUMAN OTC DRUG ConRx Sinus Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride TABLET ORAL 20130215 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 E 20171231 68737-237_71fe9cd2-cd77-406e-9dc9-9d977871ae01 68737-237 HUMAN OTC DRUG ConRx AR ALUMINUM HYDROXIDE and MAGNESIUM HYDROXIDE TABLET, CHEWABLE ORAL 20130318 OTC MONOGRAPH FINAL part331 Eagle Distributors,Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE 160; 105 mg/1; mg/1 E 20171231 68737-238_13b8d214-6167-49c7-bca3-acb3ea7515a5 68737-238 HUMAN OTC DRUG ConRX DayTime Phenylephrine Hydrochloride, Acetaminophen, Dextromethorphan Hydrobromide, and Guaifenesin TABLET ORAL 20140131 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 325; 10; 200 mg/1; mg/1; mg/1; mg/1 E 20171231 68737-239_490fee50-f524-48dc-ad57-8bfa983f9e46 68737-239 HUMAN OTC DRUG ConRx NightTime Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate TABLET ORAL 20140210 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 E 20171231 68737-240_ba30bedb-b54d-447c-a17c-088c0fe5cd38 68737-240 HUMAN OTC DRUG ConRX Pain Reliever Sinus Headache Phenylephrine Hydrochloride and Acetaminophen TABLET ORAL 20140131 OTC MONOGRAPH FINAL part341 Eagle Distributors,Inc. PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 E 20171231 68745-1018_9ed37cb6-59b6-4c7f-83c0-3f3c80b0ea17 68745-1018 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 12 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-1019_9ed37cb6-59b6-4c7f-83c0-3f3c80b0ea17 68745-1019 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 22 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-1020_9ed37cb6-59b6-4c7f-83c0-3f3c80b0ea17 68745-1020 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 32 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-1021_9ed37cb6-59b6-4c7f-83c0-3f3c80b0ea17 68745-1021 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 42 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-1022_9ed37cb6-59b6-4c7f-83c0-3f3c80b0ea17 68745-1022 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 52 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-1023_9ed37cb6-59b6-4c7f-83c0-3f3c80b0ea17 68745-1023 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 10 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-1024_9ed37cb6-59b6-4c7f-83c0-3f3c80b0ea17 68745-1024 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 20 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-1025_9ed37cb6-59b6-4c7f-83c0-3f3c80b0ea17 68745-1025 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 30 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-1026_9ed37cb6-59b6-4c7f-83c0-3f3c80b0ea17 68745-1026 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 40 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-1027_9ed37cb6-59b6-4c7f-83c0-3f3c80b0ea17 68745-1027 HUMAN OTC DRUG VITALUMIERE AQUA ULTRA-LIGHT SKIN PERFECTING SUNSCREEN MAKEUP BROAD SPECTRUM SPF 15, 50 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-1034_82afa354-5bd3-473b-94c3-2bc9fdb408a2 68745-1034 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 20 CLAIR OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL N 20181231 68745-1035_82afa354-5bd3-473b-94c3-2bc9fdb408a2 68745-1035 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 30 CENDRE OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL N 20181231 68745-1036_82afa354-5bd3-473b-94c3-2bc9fdb408a2 68745-1036 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 40 BEIGE OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL N 20181231 68745-1037_82afa354-5bd3-473b-94c3-2bc9fdb408a2 68745-1037 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 50 NATUREL OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL N 20181231 68745-1038_82afa354-5bd3-473b-94c3-2bc9fdb408a2 68745-1038 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 07 IVOIRE OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL N 20181231 68745-1039_82afa354-5bd3-473b-94c3-2bc9fdb408a2 68745-1039 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 35 SOFT BISQUE OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL N 20181231 68745-1040_82afa354-5bd3-473b-94c3-2bc9fdb408a2 68745-1040 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 41 NATURAL BEIGE OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL N 20181231 68745-1041_82afa354-5bd3-473b-94c3-2bc9fdb408a2 68745-1041 HUMAN OTC DRUG VITALUMIERE MOISTURE-RICH RADIANCE SUNSCREEN FLUID MAKEUP, BROAD SPECTRUM SPF 15, 51 TAWNY BEIGE OCTINOXATE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE 50 mg/mL N 20181231 68745-1042_f7bd4ea4-8a99-4d1f-b60e-005b58429082 68745-1042 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING SUNSCREEN FLUID MAKEUP BROAD SPECTRUM SPF 15, 14 IVOIRE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 75; 56 mg/mL; mg/mL N 20181231 68745-1044_f7bd4ea4-8a99-4d1f-b60e-005b58429082 68745-1044 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING SUNSCREEN FLUID MAKEUP BROAD SPECTRUM SPF 15, 30 CENDRE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 75; 56 mg/mL; mg/mL N 20181231 68745-1045_f7bd4ea4-8a99-4d1f-b60e-005b58429082 68745-1045 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING SUNSCREEN FLUID MAKEUP BROAD SPECTRUM SPF 15, 40 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 75; 56 mg/mL; mg/mL N 20181231 68745-1049_f7bd4ea4-8a99-4d1f-b60e-005b58429082 68745-1049 HUMAN OTC DRUG LIFT LUMIERE FIRMING AND SMOOTHING SUNSCREEN FLUID MAKEUP BROAD SPECTRUM SPF 15, 41 SOFT BISQUE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20120701 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 75; 56 mg/mL; mg/mL N 20181231 68745-2016_31a2e187-531e-47c6-a8ba-e59c4c2235ad 68745-2016 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 10 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g N 20181231 68745-2017_31a2e187-531e-47c6-a8ba-e59c4c2235ad 68745-2017 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 20 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g N 20181231 68745-2018_31a2e187-531e-47c6-a8ba-e59c4c2235ad 68745-2018 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 30 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g N 20181231 68745-2019_31a2e187-531e-47c6-a8ba-e59c4c2235ad 68745-2019 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 40 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g N 20181231 68745-2020_31a2e187-531e-47c6-a8ba-e59c4c2235ad 68745-2020 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 50 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g N 20181231 68745-2021_31a2e187-531e-47c6-a8ba-e59c4c2235ad 68745-2021 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 60 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g N 20181231 68745-2022_31a2e187-531e-47c6-a8ba-e59c4c2235ad 68745-2022 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW SHEER COLOUR, BROAD SPECTRUM SPF 15 SUNSCREEN, No 70 OCTINOXATE and TITANIUM DIOXIDE POWDER TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .84; .96 g/12g; g/12g N 20181231 68745-2025_785ba73c-fe0e-40fa-a9c2-6e3392f3c388 68745-2025 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 12 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL N 20181231 68745-2026_785ba73c-fe0e-40fa-a9c2-6e3392f3c388 68745-2026 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 22 BEIGE ROSE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL N 20181231 68745-2027_785ba73c-fe0e-40fa-a9c2-6e3392f3c388 68745-2027 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 10 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL N 20181231 68745-2028_785ba73c-fe0e-40fa-a9c2-6e3392f3c388 68745-2028 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 20 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL N 20181231 68745-2029_785ba73c-fe0e-40fa-a9c2-6e3392f3c388 68745-2029 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 30 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL N 20181231 68745-2030_785ba73c-fe0e-40fa-a9c2-6e3392f3c388 68745-2030 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 40 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL N 20181231 68745-2031_785ba73c-fe0e-40fa-a9c2-6e3392f3c388 68745-2031 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 50 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL N 20181231 68745-2032_785ba73c-fe0e-40fa-a9c2-6e3392f3c388 68745-2032 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 60 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL N 20181231 68745-2033_785ba73c-fe0e-40fa-a9c2-6e3392f3c388 68745-2033 HUMAN OTC DRUG PERFECTION LUMIERE VELVET SMOOTH-EFFECT MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN, 70 BEIGE OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20140303 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 50; 31 mg/mL; mg/mL N 20181231 68745-2044_90934ea9-b5b6-4d60-bc57-dc1e8992bf14 68745-2044 HUMAN OTC DRUG CC COMPLETE CORRECTION SUNSCREEN BROAD SPECTRUM SPF 50, 20 BEIGE Octinoxate, Titanium dioxide, and Zinc Oxide CREAM TOPICAL 20150504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 32; 152 mg/mL; mg/mL; mg/mL N 20181231 68745-2045_90934ea9-b5b6-4d60-bc57-dc1e8992bf14 68745-2045 HUMAN OTC DRUG CC COMPLETE CORRECTION SUNSCREEN BROAD SPECTRUM SPF 50, 30 BEIGE Octinoxate, Titanium dioxide, and Zinc Oxide CREAM TOPICAL 20150504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 32; 152 mg/mL; mg/mL; mg/mL N 20181231 68745-2046_90934ea9-b5b6-4d60-bc57-dc1e8992bf14 68745-2046 HUMAN OTC DRUG CC COMPLETE CORRECTION SUNSCREEN BROAD SPECTRUM SPF 50, 40 BEIGE Octinoxate, Titanium dioxide, and Zinc Oxide CREAM TOPICAL 20150504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 32; 152 mg/mL; mg/mL; mg/mL N 20181231 68745-2049_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2049 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No 10 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2050_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2050 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No 20 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2051_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2051 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No 21 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2052_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2052 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No 30 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2053_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2053 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No 40 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2054_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2054 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No 50 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2055_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2055 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No 60 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2056_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2056 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No70 OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2057_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2057 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No12 Rose OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2058_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2058 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No22 Rose OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2059_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2059 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No32 Rose OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2060_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2060 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No42 Rose OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2061_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2061 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No91 Caramel OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2062_4f0d2ca0-738e-4a24-9c34-caa2d238ca7f 68745-2062 HUMAN OTC DRUG LES BEIGES HEALTHY GLOW FOUNDATION BROAD SPECTRUM SPF 25 SUNSCREEN No121 Caramel OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE 60; 56 mg/mL; mg/mL N 20181231 68745-2063_6b9e588d-9366-447b-bcf7-dfe9dfc3d52b 68745-2063 HUMAN OTC DRUG LE BLANC LIGHT CREATOR BRIGHTENING MAKEUP BASE BROAD SPECTRUM SPF 40 SUNSCREEN, 20 MIMOSA Octinoxate, Titanium dioxide, and Zinc Oxide EMULSION TOPICAL 20160215 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 40; 67; 95 mg/mL; mg/mL; mg/mL N 20181231 68745-2064_9d7e2788-929f-4c0b-8469-d07544d726ca 68745-2064 HUMAN OTC DRUG LE BLANC LIGHT CREATOR BRIGHTENING MAKEUP BASE BROAD SPECTRUM SPF 40 SUNSCREEN, 10 ROSEE Octinoxate, Titanium dioxide, and Zinc Oxide EMULSION TOPICAL 20160215 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 40; 67; 95 mg/mL; mg/mL; mg/mL N 20181231 68745-2065_325a71fb-b092-4b74-a717-aa0285cbdb3b 68745-2065 HUMAN OTC DRUG UV ESSENTIEL DAILY DEFENSE SUNSCREEN ANTI-POLLUTION BROAD SPECTRUM SPF 30 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE EMULSION TOPICAL 20160218 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 54; 171 mg/mL; mg/mL; mg/mL N 20181231 68745-2066_6ddca962-4883-4682-a1b2-baf7e4a5b83f 68745-2066 HUMAN OTC DRUG UV ESSENTIEL DAILY DEFENSE SUNSCREEN ANTI-POLLUTION BROAD SPECTRUM SPF 50 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE EMULSION TOPICAL 20160218 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 54; 171 mg/mL; mg/mL; mg/mL N 20181231 68745-2067_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2067 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 12 BEIGE ROSE Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2068_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2068 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 22 BEIGE ROSE Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2069_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2069 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 32 BEIGE ROSE Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2070_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2070 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 42 BEIGE ROSE Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2071_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2071 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 10 BEIGE Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2072_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2072 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 20 BEIGE Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2073_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2073 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 21 BEIGE Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2074_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2074 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 30 BEIGE Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2075_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2075 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 40 BEIGE Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2076_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2076 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 50 BEIGE Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2077_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2077 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 60 BEIGE Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2078_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2078 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 70 BEIGE Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2079_2b770286-02d3-48a0-b611-bf8920043e3c 68745-2079 HUMAN OTC DRUG LE TEINT ULTRA TENUE ULTRAWEAR FLAWLESS COMPACT FOUNDATION BROAD SPECTRUM SPF 15 SUNCREEEN 91 CARAMEL Octinoxate, Titanium dioxide, and Zinc Oxide POWDER TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .65; .624; 1.235 g/13g; g/13g; g/13g N 20181231 68745-2080_1658f461-6d5e-4320-a802-50645c9a1d6e 68745-2080 HUMAN OTC DRUG Les Beiges Gel Touch Healthy Glow Tint Broad Spectrum SPF 15 Sunscreen No 10 Octinoxate and Titanium Dioxide GEL TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .748; .264 g/11g; g/11g N 20181231 68745-2081_1658f461-6d5e-4320-a802-50645c9a1d6e 68745-2081 HUMAN OTC DRUG Les Beiges Gel Touch Healthy Glow Tint Broad Spectrum SPF 15 Sunscreen No 20 Octinoxate and Titanium dioxide GEL TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .748; .264 g/11g; g/11g N 20181231 68745-2082_1658f461-6d5e-4320-a802-50645c9a1d6e 68745-2082 HUMAN OTC DRUG Les Beiges Gel Touch Healthy Glow Tint Broad Spectrum SPF 15 Sunscreen No 21 Octinoxate and Titanium dioxide GEL TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .748; .264 g/11g; g/11g N 20181231 68745-2083_1658f461-6d5e-4320-a802-50645c9a1d6e 68745-2083 HUMAN OTC DRUG Les Beiges Gel Touch Healthy Glow Tint Broad Spectrum SPF 15 Sunscreen No 30 Octinoxate and Titanium dioxide GEL TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .748; .264 g/11g; g/11g N 20181231 68745-2084_1658f461-6d5e-4320-a802-50645c9a1d6e 68745-2084 HUMAN OTC DRUG Les Beiges Gel Touch Healthy Glow Tint Broad Spectrum SPF 15 Sunscreen No 40 Octinoxate and Titanium dioxide GEL TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .748; .264 g/11g; g/11g N 20181231 68745-2085_1658f461-6d5e-4320-a802-50645c9a1d6e 68745-2085 HUMAN OTC DRUG Les Beiges Gel Touch Healthy Glow Tint Broad Spectrum SPF 15 Sunscreen No 50 Octinoxate and Titanium dioxide GEL TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .748; .264 g/11g; g/11g N 20181231 68745-2086_1658f461-6d5e-4320-a802-50645c9a1d6e 68745-2086 HUMAN OTC DRUG Les Beiges Gel Touch Healthy Glow Tint Broad Spectrum SPF 15 Sunscreen No 60 Octinoxate and Titanium dioxide GEL TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .748; .264 g/11g; g/11g N 20181231 68745-2087_1658f461-6d5e-4320-a802-50645c9a1d6e 68745-2087 HUMAN OTC DRUG Les Beiges Gel Touch Healthy Glow Tint Broad Spectrum SPF 15 Sunscreen No 12 Rose Octinoxate and Titanium dioxide GEL TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .748; .264 g/11g; g/11g N 20181231 68745-2088_1658f461-6d5e-4320-a802-50645c9a1d6e 68745-2088 HUMAN OTC DRUG Les Beiges Gel Touch Healthy Glow Tint Broad Spectrum SPF 15 Sunscreen No 22 Rose Octinoxate and Titanium dioxide GEL TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .748; .264 g/11g; g/11g N 20181231 68745-2089_1658f461-6d5e-4320-a802-50645c9a1d6e 68745-2089 HUMAN OTC DRUG Les Beiges Gel Touch Healthy Glow Tint Broad Spectrum SPF 15 Sunscreen No 91 Caramel Octinoxate and Titanium dioxide GEL TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part352 CHANEL PARFUMS BEAUTE OCTINOXATE; TITANIUM DIOXIDE .748; .264 g/11g; g/11g N 20181231 68747-6027_77714ef0-e991-4294-9566-9117cf851d6d 68747-6027 HUMAN OTC DRUG Freshmint Anticavity Fluoride Gel Toothpaste Fluoride Toothpaste PASTE, DENTIFRICE DENTAL 20090825 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM FLUORIDE 2.2 mg/g E 20171231 68747-6028_7b64f179-d501-48d7-80d6-40485dda052d 68747-6028 HUMAN OTC DRUG Maxixum Security Gel Toothpaste Fluoride Toothpaste PASTE, DENTIFRICE DENTAL 20090825 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM FLUORIDE 2.2 mg/g E 20171231 68747-6029_3161f610-bf6e-45ee-89b4-10f65c908c61 68747-6029 HUMAN OTC DRUG Iodent Fluoride Toothpaste Fluoride Toothpaste PASTE, DENTIFRICE DENTAL 20090825 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 68747-6030_8eea2823-e207-4870-b9f9-25eae9637a7c 68747-6030 HUMAN OTC DRUG Maxixum Security Gel Toothpaste Fluoride Toothpaste PASTE, DENTIFRICE DENTAL 20090825 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM FLUORIDE 2.2 mg/g E 20171231 68747-6031_7bbd3de6-b26b-49bf-80e8-717d6b33ed17 68747-6031 HUMAN OTC DRUG Freshmint Sensitive Toothpaste Fluoride Toothpaste PASTE, DENTIFRICE DENTAL 20090825 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM FLUORIDE; POTASSIUM NITRATE 2.4; 50 mg/g; mg/g E 20171231 68747-6032_0b12c46c-f046-4cb1-a290-4795b196e2ff 68747-6032 HUMAN OTC DRUG Iodent Fluoride Mint SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20120228 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g N 20181231 68747-6033_0595271e-2083-4c54-9201-ec3a7672dad7 68747-6033 HUMAN OTC DRUG Bee Smart SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20120228 OTC MONOGRAPH FINAL part355 Dabur India Limited SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g E 20171231 68752-005_5cca5471-1066-2d4f-e053-2991aa0ae042 68752-005 HUMAN OTC DRUG Cetirizine hydrochloride Cetirizine hydrochloride TABLET ORAL 20100625 ANDA ANDA077498 TriMarc Labs CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 68752-012_5cca4798-0037-b8ac-e053-2a91aa0a9d71 68752-012 HUMAN OTC DRUG GUAIFENESIN DM GUAIFENESIN DEXTROMETHORPHAN TABLET ORAL 20120417 OTC MONOGRAPH FINAL part341 PD-Rx Pharmaceuticals, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 68752-015_4f305424-ff92-6796-e054-00144ff88e88 68752-015 HUMAN OTC DRUG Lidocaine 5% Lidocaine 5% CREAM TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part348 TriMarc Labs LIDOCAINE 5 g/100g N 20181231 68752-022_5cca8178-9e03-7022-e053-2991aa0aea8f 68752-022 HUMAN OTC DRUG EC-81Aspirin Enteric Coated Aspirin TABLET, DELAYED RELEASE ORAL 20100811 OTC MONOGRAPH FINAL part343 TriMarc Labs ASPIRIN 81 mg/1 N 20181231 68752-024_4f93d6e8-3a18-20b4-e054-00144ff8d46c 68752-024 HUMAN OTC DRUG Lidocaine Lidocaine CREAM TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part348 PD-Rx Pharmaceuticals, Inc. LIDOCAINE 4 g/100g N 20181231 68752-025_5ccaeda4-c88a-1b1f-e053-2a91aa0a695e 68752-025 HUMAN PRESCRIPTION DRUG Nitroglycerin ER Nitroglycerin CAPSULE ORAL 20140620 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. NITROGLYCERIN 2.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68752-065_628333b4-1489-de1c-e053-2a91aa0a8aa2 68752-065 HUMAN PRESCRIPTION DRUG Nitroglycerin ER Nitroglycerin CAPSULE ORAL 20100510 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 68752-090_5cd944d9-9904-e78a-e053-2a91aa0ac869 68752-090 HUMAN PRESCRIPTION DRUG Nitroglycerin ER Nitroglycerin CAPSULE ORAL 20140619 UNAPPROVED DRUG OTHER PD-Rx Pharmaceuticals, Inc. NITROGLYCERIN 9 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68754-150_50092344-ecd8-4da4-aa57-3132bbb8c8a8 68754-150 HUMAN OTC DRUG Medicated Anti-Fungal Miconazole Miconazole Nitrate LIQUID TOPICAL 20100602 OTC MONOGRAPH FINAL part333 American Spraytech, LLC MICONAZOLE NITRATE 2 g/100g N 20181231 68754-204_61577394-f466-ae6d-e053-2991aa0a7194 68754-204 HUMAN OTC DRUG Athletes Foot TOLNAFTATE SPRAY TOPICAL 20171227 OTC MONOGRAPH FINAL part333C American Spraytech, LLC TOLNAFTATE 10 mg/g N 20181231 68754-205_6157820d-4617-ea51-e053-2991aa0a847b 68754-205 HUMAN OTC DRUG Athletes Foot TMiconazole Nitrate MICONAZOLE NITRATE SPRAY TOPICAL 20171226 OTC MONOGRAPH FINAL part333C American Spraytech, LLC MICONAZOLE NITRATE 20 mg/g N 20181231 68754-206_615773bc-0899-fc39-e053-2a91aa0af00f 68754-206 HUMAN OTC DRUG Hydrocortisone HYDROCORTISONE LIQUID TOPICAL 20171226 OTC MONOGRAPH NOT FINAL part348 American Spraytech, LLC HYDROCORTISONE 10 mg/g N 20181231 68754-207_6157875b-d992-f0e5-e053-2991aa0a1217 68754-207 HUMAN OTC DRUG Jock Itch Miconazole Nitrate Antifungal MICONAZOLE NITRATE SPRAY TOPICAL 20171226 OTC MONOGRAPH FINAL part333C American Spraytech, LLC MICONAZOLE NITRATE 20 mg/g N 20181231 68754-208_61578766-8d57-ea53-e053-2991aa0a9919 68754-208 HUMAN OTC DRUG Odor Control Tolnaftate TOLNAFTATE SPRAY TOPICAL 20171226 OTC MONOGRAPH FINAL part333C American Spraytech, LLC TOLNAFTATE 10 mg/g N 20181231 68754-209_6157820d-462c-ea51-e053-2991aa0a847b 68754-209 HUMAN OTC DRUG Dermoplast Anesthetic Pain Relieving Antibacterial BENZOCAINE, MENTHOL SPRAY TOPICAL 20171226 OTC MONOGRAPH NOT FINAL part348 American Spraytech, LLC BENZOCAINE; MENTHOL 200; 5 mg/g; mg/g N 20181231 68754-210_61578766-8d69-ea53-e053-2991aa0a9919 68754-210 HUMAN OTC DRUG Dermoplast First Aid BENZETHONIUM CHLORIDE, BENZOCAINE SPRAY TOPICAL 20171226 OTC MONOGRAPH NOT FINAL part348 American Spraytech, LLC BENZETHONIUM CHLORIDE; BENZOCAINE 2; 200 mg/g; mg/g N 20181231 68758-009_24a1d522-1d6d-4ec2-a80e-971908135b34 68758-009 HUMAN OTC DRUG EXTEN-10 INSTANT YOUTH BOOSTING MOISTURIZER SPF 15 OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20100415 OTC MONOGRAPH NOT FINAL part352 GOOD SKIN DERMACARE OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 5; 3 mL/100mL; mL/100mL; mL/100mL N 20181231 68758-010_25b253bd-6daa-47f1-bdcb-66812d2671a7 68758-010 HUMAN OTC DRUG BB10 INSTANT SKIN PERFECTOR BROAD SPECTRUM SPF 35 OCTINOXATE, OCTISALATE, OXYBENZONE, and TITANIUM DIOXIDE LIQUID TOPICAL 20111027 OTC MONOGRAPH NOT FINAL part352 GOOD SKIN DERMACARE OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE .08175; .0436; .02725; .01199 g/mL; g/mL; g/mL; g/mL N 20181231 68759-003_d0b487ac-4e50-45d1-b5ae-844b65e3c8af 68759-003 HUMAN OTC DRUG YOUTH FULL TINTED MOISTURIZER SPF 15 OCTINOXATE, TITANIUM DIOXIDE LIQUID TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 AMERICAN BEAUTY COSMETICS OCTINOXATE; TITANIUM DIOXIDE 7.5; 3 mL/100mL; mL/100mL E 20171231 68762-107_04f5a95a-2315-407f-9579-ff51c88cd2cf 68762-107 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040201 UNAPPROVED MEDICAL GAS American Home Medical Equipment Co. LLC OXYGEN 99 L/100L E 20171231 68769-002_ff1e816b-ec2f-45d2-8c9b-e0efa83651ae 68769-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Dealer's Medical Equipment Solutions Inc dba Colorado Compressed Gases, Inc. OXYGEN 99 L/100L E 20171231 68770-101_f5ab18fa-f612-4a84-afcc-69c65b226a07 68770-101 HUMAN OTC DRUG Womens Dry Eye Pulsatilla, Sepia, Euphrasia, Alumina, Arsenicum album, Nux mosch, Zincum m LIQUID INTRAOCULAR 20040601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; EUPHRASIA STRICTA; ALUMINUM OXIDE; ARSENIC TRIOXIDE; NUTMEG; ZINC 8; 8; 5; 10; 12; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68770-102_9f73d25b-93f4-4081-bc9f-5fc6913def8b 68770-102 HUMAN OTC DRUG Dry Eye Forte Sulphur, Strychnos Nux-Vomica Seed, Euphrasia Stricta, Aluminum Oxide, Arsenic Trioxide, Nutmeg, Zinc LIQUID INTRAOCULAR 20040601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc SULFUR; STRYCHNOS NUX-VOMICA SEED; EUPHRASIA STRICTA; ALUMINUM OXIDE; ARSENIC TRIOXIDE; NUTMEG; ZINC 6; 12; 5; 10; 12; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68770-103_1922e470-0a70-1edf-e054-00144ff8d46c 68770-103 HUMAN OTC DRUG Womens Tear Stimulation Pulsatilla, Sepia, Euphrasia, Alumina, Arsenicum album, Nux mosch, Zincum m LIQUID INTRAOCULAR 20150619 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; EUPHRASIA STRICTA; ALUMINUM OXIDE; ARSENIC TRIOXIDE; NUTMEG; ZINC 8; 8; 5; 10; 12; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 68770-104_1b0592cb-0880-659d-e054-00144ff88e88 68770-104 HUMAN OTC DRUG Tear Stimulation Forte Sulphur, Strychnos Nux-Vomica Seed, Euphrasia Stricta, Aluminum Oxide, Arsenic Trioxide, Nutmeg, Zinc LIQUID OPHTHALMIC 20150601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc SULFUR; STRYCHNOS NUX-VOMICA SEED; EUPHRASIA STRICTA; ALUMINUM OXIDE; ARSENIC TRIOXIDE; NUTMEG; ZINC 6; 12; 5; 10; 12; 6; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 68770-120_31a0aa57-48af-41a6-b47e-16ba10cd6fd6 68770-120 HUMAN OTC DRUG Allergy Desensitization Onion, Apis Mellifera, Schoenocaulon Officinale Seed, Euphrasia Stricta LIQUID INTRAOCULAR 20040601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc ONION; APIS MELLIFERA; SCHOENOCAULON OFFICINALE SEED; EUPHRASIA STRICTA 6; 6; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68770-130_13dd31b5-2390-4faf-9a0f-542a67c006ee 68770-130 HUMAN OTC DRUG Cataract Crystalline Lens Cineraria Maritima, Euphrasia Strictica, Causticum, Calcarea phosphorica, Sepia, Calcarea flourica, Silicea LIQUID INTRAOCULAR 20040601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc JACOBAEA MARITIMA; EUPHRASIA STRICTA; CAUSTICUM; TRIBASIC CALCIUM PHOSPHATE; SEPIA OFFICINALIS JUICE; CALCIUM FLUORIDE; SILICON DIOXIDE 5; 6; 6; 10; 6; 11; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68770-142_34eca2e8-9066-4cff-b9b7-4ebaefdf43d3 68770-142 HUMAN OTC DRUG Ortho-K Thin (Daytime) Aluminum Oxide, Apis mellifera, Arsenic Trioxide, Calendula Officinalis Flowering Top, Tribasic Calcium Phosphate, Euphrasia Stricta, Delphinium Staphisagria Seeds, Sulphur LIQUID INTRAOCULAR 20040601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; CALENDULA OFFICINALIS FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; EUPHRASIA STRICTA; DELPHINIUM STAPHISAGRIA SEED; SULFUR 12; 6; 8; 7; 12; 6; 6; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68770-143_1b374437-92d5-4b9d-a832-3a5ad26bc7bb 68770-143 HUMAN OTC DRUG Ortho-K Thick (Night) Euphrasia Stricta, Aluminum Oxide, Arsenic Trioxide, Apis mellifera, Tribasic Calcium Phosphate, Delphinium Staphisagria Seeds, Sulphur, Calendula Officinalis Flowering Top LIQUID INTRAOCULAR 20040601 UNAPPROVED HOMEOPATHIC Natural Ophthalmics, Inc EUPHRASIA STRICTA; ALUMINUM OXIDE; ARSENIC TRIOXIDE; APIS MELLIFERA; TRIBASIC CALCIUM PHOSPHATE; DELPHINIUM STAPHISAGRIA SEED; SULFUR; CALENDULA OFFICINALIS FLOWERING TOP 6; 12; 8; 6; 12; 6; 7; 7 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL E 20171231 68776-1001_25d2009c-2f79-4de4-9670-2f2b6a29eed1 68776-1001 HUMAN OTC DRUG Wyandotte Sanifect E3 ALCOHOL LOTION TOPICAL 20061001 OTC MONOGRAPH NOT FINAL part333E Alex C. Fergusson, Inc. ALCOHOL 60.1 L/100L N 20181231 68776-1003_57b676c7-a336-4def-871e-2b3ebb19348a 68776-1003 HUMAN OTC DRUG WYANDOTTE SANIFECT E3-NA BENZALKONIUM CHLORIDE LOTION TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333A Alex C. Fergusson, Inc. BENZALKONIUM CHLORIDE 99468.4 g/100L N 20181231 68776-1004_6af3eca5-f342-4442-b497-b78d380daa81 68776-1004 HUMAN OTC DRUG WYANDOTTE SANIFECT E2 BENZALKONIUM CHLORIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333A Alex C. Fergusson, Inc. BENZALKONIUM CHLORIDE 268575.42 mg/208198mL E 20171231 68776-1005_abcebd68-bb93-42bd-826b-7968c14f55f4 68776-1005 HUMAN OTC DRUG WYANDOTTE SANIFECT FOAM-E II CHLOROXYLENOL LIQUID TOPICAL 20090106 OTC MONOGRAPH NOT FINAL part333A Alex C. Fergusson, Inc. CHLOROXYLENOL 2081980 mg/208198mL E 20171231 68776-1006_8076d92c-76dd-4da7-b3e5-51a0210cca43 68776-1006 HUMAN OTC DRUG AFCO 5512 BENZALKONIUM CHLORIDE LIQUID TOPICAL 20121101 OTC MONOGRAPH NOT FINAL part333A Alex C. Fergusson, Inc. BENZALKONIUM CHLORIDE 1.29 mg/mL E 20171231 68782-001_48b1952b-3ef6-4437-8592-5f4f4543e370 68782-001 HUMAN PRESCRIPTION DRUG Macugen pegaptanib sodium INJECTION, SOLUTION INTRAVITREAL 20041217 NDA NDA021756 Bausch & Lomb Incorporated PEGAPTANIB SODIUM 3.47 mg/mL Oligonucleotides [Chemical/Ingredient],Aptamers, Nucleotide [Chemical/Ingredient] N 20181231 68784-101_9fbf7acd-f075-4a82-a47d-d0484055bfc5 68784-101 HUMAN OTC DRUG Hemorrhoidal COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20140401 OTC MONOGRAPH FINAL part346 Acino Products, LLC. COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 1768.8; 5 mg/1; mg/1 N 20181231 68784-102_80ab9dbd-08db-4aa1-afff-6daf6987b2b7 68784-102 HUMAN OTC DRUG BISACODYL BISACODYL SUPPOSITORY RECTAL 20050101 OTC MONOGRAPH NOT FINAL part334 Acino Products, LLC BISACODYL 10 mg/1 N 20181231 68784-108_7b79a8c2-83a2-46ff-99bc-01b1c61bfd74 68784-108 HUMAN PRESCRIPTION DRUG Rectacort - HC HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20061101 UNAPPROVED DRUG OTHER Acino Products, LLC. HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68784-112_cef5fab7-bc9e-47ef-aa33-7281e450d5cd 68784-112 HUMAN OTC DRUG ACETAMINOPHEN For Children ACETAMINOPHEN SUPPOSITORY RECTAL 20151229 OTC MONOGRAPH NOT FINAL part343 Acino Products, LLC ACETAMINOPHEN 120 mg/1 N 20181231 68784-113_4cdf03c7-e115-44f3-9cad-f4b934fac6de 68784-113 HUMAN OTC DRUG ACETAMINOPHEN For Adults ACETAMINOPHEN SUPPOSITORY RECTAL 20151229 OTC MONOGRAPH NOT FINAL part343 Acino Products, LLC ACETAMINOPHEN 650 mg/1 N 20181231 68786-120_785db725-1549-4af4-bd79-3eae8658adea 68786-120 HUMAN OTC DRUG alcohol alcohol SWAB TOPICAL 20111219 OTC MONOGRAPH FINAL part344 Sion Biotext Medical Ltd ISOPROPYL ALCOHOL .7 mL/mL N 20181231 68786-121_950a3dc6-7a57-4341-8d64-7721071a4c24 68786-121 HUMAN OTC DRUG alcohol alcohol SWAB TOPICAL 20120629 OTC MONOGRAPH NOT FINAL part333A Sion Biotext Medical Ltd ISOPROPYL ALCOHOL .7 mL/mL N 20181231 68786-122_f56a7ef1-3180-46f0-916f-ff354bcbc63d 68786-122 HUMAN OTC DRUG alcohol alcohol SWAB TOPICAL 20140425 OTC MONOGRAPH FINAL part344 Sion Biotext Medical Ltd ISOPROPYL ALCOHOL .7 mL/mL N 20181231 68786-130_ff0021d3-be67-4e30-b86c-593cc279e122 68786-130 HUMAN OTC DRUG Povidone Iodine POVIDONE-IODINE SWAB TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part333A Sion Biotext Medical Ltd POVIDONE-IODINE .1 g/1 N 20181231 68786-132_b9b37f1f-e7f6-4f9b-b8dc-2d59f14c49d7 68786-132 HUMAN OTC DRUG Povidone Iodine Prep Povidone Iodine SOLUTION TOPICAL 20150716 OTC MONOGRAPH FINAL part333C Sion Biotext Medical Ltd POVIDONE-IODINE 1 g/100mL N 20181231 68786-140_95e3d9a2-9981-4dc2-9f21-4859fd2e3eaf 68786-140 HUMAN OTC DRUG Povidone Iodine POVIDONE-IODINE SWAB TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part333A Sion Biotext Medical Ltd POVIDONE-IODINE .1 g/1 N 20181231 68786-160_0a4fa09b-09a8-40f2-a280-1df8d8bc852c 68786-160 HUMAN OTC DRUG Lemon Glycerin SWAB ORAL 20130411 OTC MONOGRAPH NOT FINAL part356 Sion Biotext Medical Ltd GLYCERIN 7.5 1/1 N 20181231 68786-211_a5f1ac60-08c1-4598-a8c3-0b62a81bdc34 68786-211 HUMAN OTC DRUG WHITE PETROLATUM PETROLATUM JELLY TOPICAL 20140216 OTC MONOGRAPH FINAL part347 Sion Biotext Medical Ltd PETROLATUM 1 g/g N 20181231 68786-212_43831d2a-705c-4715-bfaf-f8f61443ec58 68786-212 HUMAN OTC DRUG Vitamin A D PETROLATUM OINTMENT TOPICAL 20120709 OTC MONOGRAPH FINAL part347 Sion Biotext Medical Ltd. PETROLATUM .75 g/g N 20181231 68786-213_2246396f-68c6-4052-8f78-c6ba7e90db2f 68786-213 HUMAN OTC DRUG Vitamin A D WHITE PETROLATUM OINTMENT TOPICAL 20170214 OTC MONOGRAPH FINAL part347 Sion Biotext Medical Ltd. PETROLATUM .93 g/g N 20181231 68786-216_9986626d-c09a-4bc6-9190-a9c59ba336d8 68786-216 HUMAN OTC DRUG bacitracin zinc, neomycin sulfate and polymyxin b sulfate bacitracin zinc, neomycin sulfate and polymyxin b sulfate OINTMENT TOPICAL 20120709 OTC MONOGRAPH FINAL part333B Sion Biotext Medical Ltd BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 68786-218_79407333-c9ab-4dca-a6df-1b5ade485918 68786-218 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20120709 OTC MONOGRAPH FINAL part333B Sion Biotext Medical Ltd BACITRACIN 500 [iU]/g N 20181231 68786-220_12837633-fbd1-4a13-bbd7-6cf053c915f4 68786-220 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20120706 OTC MONOGRAPH FINAL part333B Sion Biotext Medical Ltd BACITRACIN ZINC 500 [iU]/g N 20181231 68786-224_cd0d0455-29ab-4a73-ad9e-10fe245f6245 68786-224 HUMAN OTC DRUG Hydrocortisone Hydrocortisone Acetate CREAM TOPICAL 20120706 OTC MONOGRAPH NOT FINAL part348 Sion Biotext Medical Ltd HYDROCORTISONE ACETATE 1 g/100g N 20181231 68786-226_c310d58b-765f-46fb-8814-49245c9b5734 68786-226 HUMAN OTC DRUG zinc oxide zinc oxide OINTMENT TOPICAL 20100201 OTC MONOGRAPH FINAL part347 Sion Biotext Medical Ltd ZINC OXIDE 1.8 g/100g N 20181231 68786-228_f967244a-c42c-4406-99ba-40d2c0135fc4 68786-228 HUMAN OTC DRUG zinc oxide zinc oxide OINTMENT TOPICAL 20100201 OTC MONOGRAPH FINAL part347 Sion Biotext Medical Ltd ZINC OXIDE 1.8 g/100g N 20181231 68786-232_77de996f-4d00-42bf-9a52-daefa0c732c6 68786-232 HUMAN OTC DRUG Lanolin Lanolin OINTMENT TOPICAL 20120709 OTC MONOGRAPH FINAL part347 Sion Biotext Medical Ltd LANOLIN 50 g/100g N 20181231 68786-411_a275e7c5-1171-41b6-b690-55de4a197e08 68786-411 HUMAN OTC DRUG Vitamins A and D without Lanolin White Petrolatum OINTMENT TOPICAL 20160107 OTC MONOGRAPH FINAL part346 Sion Biotext Medical Ltd PETROLATUM 93 g/100g N 20181231 68788-0005_d835eec4-0a6b-46fa-8250-e1164c239dcb 68788-0005 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110209 ANDA ANDA077032 Preferred Pharmaceuticals, Inc CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-0007_202340a7-f7cf-43ea-ae61-da7bdbd70501 68788-0007 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20141017 ANDA ANDA077534 Preferred Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-0012_2237a699-5bd8-45ba-a159-f83b07afda7e 68788-0012 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20090204 ANDA ANDA077519 Preferred Pharmaceuticals, Inc. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-0013_2237a699-5bd8-45ba-a159-f83b07afda7e 68788-0013 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20090204 ANDA ANDA077519 Preferred Pharmaceuticals, Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-0014_94ef285f-5cbb-4d65-8f0f-c12b5eb4de12 68788-0014 HUMAN OTC DRUG Rugby Hemorrhoidal Phenylephrine Hydrochloride and Fat, Hard SUPPOSITORY RECTAL 20131007 OTC MONOGRAPH FINAL part346 Preferred Pharmaceuticals, Inc. PHENYLEPHRINE HYDROCHLORIDE; FAT, HARD .00525; 1.86 g/1; g/1 N 20181231 68788-0039_e19a5fd5-1a79-46ab-abf7-72315637b4b8 68788-0039 HUMAN OTC DRUG Tears Renewed Lubricant DEXTRAN 70 SOLUTION OPHTHALMIC 20101116 OTC MONOGRAPH FINAL part349 Preferred Pharmaceuticals, Inc DEXTRAN 70; HYPROMELLOSES .001; .003 mL/mL; mL/mL E 20171231 68788-0047_51d79d1d-58d8-4be9-af75-d81f44d5e275 68788-0047 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20110331 ANDA ANDA065191 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-0048_a4487641-4454-4c5d-b512-a2b29d4babc3 68788-0048 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20130606 ANDA ANDA090467 Preferred Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-0053_17ae4000-e5d7-43a7-9735-ffddbf9065de 68788-0053 HUMAN PRESCRIPTION DRUG Buspirone HCl Buspirone hydrochloride TABLET ORAL 20130624 ANDA ANDA074253 Preferred Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 68788-0070_0599c2e6-37d4-450f-921c-4ee1f9c4c9fb 68788-0070 HUMAN OTC DRUG Clotrimazole CLOTRIMAZOLE CREAM TOPICAL 20130806 OTC MONOGRAPH FINAL part333C Preferred Pharmaceuticals, Inc. CLOTRIMAZOLE 10 mg/g N 20181231 68788-0074_830d083a-d6e2-41fb-bb5c-695a05c216db 68788-0074 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130318 ANDA ANDA075828 Preferred Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-0076_eca3e4e9-cea0-48a6-a500-e8e58baa84b5 68788-0076 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate SOLUTION ORAL 20110301 ANDA ANDA040119 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 120; 12 mg/5mL; mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20191231 68788-0118_32e1164a-8e63-488e-92c4-a0a05862fcd4 68788-0118 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20121213 OTC MONOGRAPH FINAL part336 Preferred Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 68788-0134_bd5f3896-d4e7-44f4-8b38-683dd018a696 68788-0134 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 19970917 ANDA ANDA074880 Preferred Pharmaceuticals, Inc ALBUTEROL SULFATE .83 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68788-0139_7b45cfb9-80ac-43cc-8e53-7153908b0431 68788-0139 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140521 NDA NDA019117 Preferred Pharmaceuticals, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-0141_f2d5b168-f5e3-470d-85d9-81b499e49f54 68788-0141 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20130218 ANDA ANDA075795 Preferred Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68788-0142_f2d5b168-f5e3-470d-85d9-81b499e49f54 68788-0142 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20130218 ANDA ANDA075795 Preferred Pharmaceuticals, Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68788-0149_0be500d6-e8cb-46e9-9335-99a725e8bddd 68788-0149 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20140820 ANDA ANDA086413 Preferred Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-0167_284c71ae-60ef-4d71-8b81-17fa18ad7eda 68788-0167 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150423 ANDA ANDA077127 Preferred Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-0169_68f02939-7202-4c7f-b4d3-ae44d682d678 68788-0169 HUMAN OTC DRUG Clotrimazole clotrimazole CREAM VAGINAL 20130806 ANDA ANDA074165 Preferred Pharmaceuticals, Inc. CLOTRIMAZOLE 1 g/100g N 20181231 68788-0173_5ea244a8-ddac-4511-9980-fa1b5c151427 68788-0173 HUMAN OTC DRUG DocQLace docusate sodium CAPSULE ORAL 20141112 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 68788-0177_a74b07d9-0fbd-4f1a-806a-9f253cbd5ba3 68788-0177 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 19891205 ANDA ANDA072637 Preferred Pharmaceuticals, Inc. ALBUTEROL SULFATE 4 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 68788-0178_bd9ea811-75a7-496e-85ae-89893118e067 68788-0178 HUMAN PRESCRIPTION DRUG Nystatin nystatin CREAM TOPICAL 20140113 ANDA ANDA065315 Preferred Pharmaceuticals, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 68788-0179_d1280ee4-087f-4cef-9df9-67a8730dbe1a 68788-0179 HUMAN OTC DRUG FERROUS SULFATE IRON SUPPLEMENT TABLET ORAL 20040618 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. FERROUS SULFATE 325 mg/1 N 20181231 68788-0186_11bec37e-9693-4987-844d-556b5b0d53bc 68788-0186 HUMAN OTC DRUG aspirin aspirin TABLET, COATED ORAL 20100628 OTC MONOGRAPH FINAL part343 Preferred Pharmaceuticals, Inc ASPIRIN 81 mg/1 N 20181231 68788-0190_a006cd05-7f82-4ced-b27d-e24267308629 68788-0190 HUMAN OTC DRUG Pink Bismuth Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20101201 OTC MONOGRAPH FINAL part335 Preferred Pharmaceuticals, Inc BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 68788-0225_1f8ba8c2-d9c5-49f1-9f64-812bdd40dc20 68788-0225 HUMAN OTC DRUG Earwax Removal Aid CARBAMIDE PEROXIDE LIQUID AURICULAR (OTIC) 20110523 OTC MONOGRAPH FINAL part344 Preferred Pharmaceuticals, Inc. CARBAMIDE PEROXIDE 65 mg/mL N 20181231 68788-0241_261a5fd3-43e6-4d40-807b-a6317a8c5dc2 68788-0241 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20130827 ANDA ANDA072927 Preferred Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-0253_ac3d3aa4-c029-468f-a49c-e6a93fc92111 68788-0253 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Preferred Pharmaceuticals, Inc CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 68788-0254_cb8b6e75-6865-4f77-924c-147774e15e31 68788-0254 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Preferred Pharmaceuticals, Inc CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 68788-0255_a74b07d9-0fbd-4f1a-806a-9f253cbd5ba3 68788-0255 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 19891205 ANDA ANDA072637 Preferred Pharmaceuticals, Inc. ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 68788-0285_5bec4d72-8eb1-4e30-8bd4-cf5281525011 68788-0285 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20110317 ANDA ANDA088628 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 68788-0332_8534a8e6-29b7-495d-8f41-ac7dee0e43d6 68788-0332 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20130419 ANDA ANDA074221 Preferred Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-0344_568bfea2-d2d5-4494-88df-5b1ec4326655 68788-0344 HUMAN OTC DRUG Miconazole Nitrate miconazole nitrate CREAM TOPICAL 20140902 OTC MONOGRAPH FINAL part333C Preferred Pharmaceuticals, Inc. MICONAZOLE NITRATE 20 mg/g E 20171231 68788-0353_32afff02-ee22-4e09-a8ac-e99f005519a9 68788-0353 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SOLUTION ORAL 20130923 ANDA ANDA040891 Preferred Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68788-0384_bc32c0c8-6207-4a63-9e72-c0c639e2c607 68788-0384 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20130314 ANDA ANDA040101 Preferred Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68788-0397_9b30a815-3f7a-4019-bdb2-ed49a30f30cf 68788-0397 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-0408_494f6d8f-1cc9-4025-87d7-989669c96e21 68788-0408 HUMAN PRESCRIPTION DRUG Flurazepam Flurazepam Hydrochloride CAPSULE ORAL 20120127 ANDA ANDA071108 Preferred Pharmaceuticals, Inc FLURAZEPAM HYDROCHLORIDE 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-0412_f76cc06d-34cc-47c4-a4be-69762dea2f74 68788-0412 HUMAN OTC DRUG good sense tussin dm cough and chest congestion Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20151006 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 68788-0426_b6e9e735-6335-4ddc-8d7e-1870f287e26c 68788-0426 HUMAN OTC DRUG acetaminophen for children Acetaminophen SUPPOSITORY RECTAL 20101214 ANDA ANDA070607 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN 120 mg/1 N 20191231 68788-0430_b6337c62-1d0d-43b5-a96c-14aacf96f544 68788-0430 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20130401 ANDA ANDA070184 Preferred Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 68788-0435_9b30a815-3f7a-4019-bdb2-ed49a30f30cf 68788-0435 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-0453_e1708994-a146-43b2-90e8-07164e69af62 68788-0453 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20140820 ANDA ANDA089808 Preferred Pharmaceuticals, Inc. THEOPHYLLINE ANHYDROUS 200 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68788-0474_9b30a815-3f7a-4019-bdb2-ed49a30f30cf 68788-0474 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20020129 ANDA ANDA075967 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-0483_08f0e5f9-27d2-4462-bea5-8d25b0e2a24e 68788-0483 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111107 ANDA ANDA201091 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-0504_fd6c2d4c-73ae-47f1-884a-03510d3d5c68 68788-0504 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 Preferred Pharmaceuticals, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 68788-0505_fd6c2d4c-73ae-47f1-884a-03510d3d5c68 68788-0505 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20091022 ANDA ANDA075382 Preferred Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 68788-0511_544fc219-6741-4ba8-a192-bd6a86702bed 68788-0511 HUMAN PRESCRIPTION DRUG Proctosol-HC Hydrocortisone CREAM TOPICAL 20141119 ANDA ANDA088799 Preferred Pharmaceuticals, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-0518_80fb4cea-0dc1-4f36-a26b-e1d319fc6c73 68788-0518 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20140213 NDA NDA020064 Preferred Pharmaceuticals, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 68788-0522_36408995-edce-438d-902b-cb08d550cbd5 68788-0522 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20040701 ANDA ANDA072824 Preferred Pharmaceuticals, Inc BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68788-0523_e7ac0593-37ad-45e8-b458-a2b12a6b9d2b 68788-0523 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20040721 ANDA ANDA086183 Preferred Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68788-0536_cd62953d-3cdb-46b9-9996-6435fde9831f 68788-0536 HUMAN PRESCRIPTION DRUG Trimethoprim sulfate and Polymyxin B sulfate Trimethoprim sulfate and Polymyxin B sulfate SOLUTION OPHTHALMIC 20151020 ANDA ANDA065006 Preferred Pharmaceuticals Inc. TRIMETHOPRIM SULFATE; POLYMYXIN B SULFATE 1; 10000 mg/mL; [USP'U]/mL Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] E 20171231 68788-0547_cf749c3f-60e9-4f35-b869-9361e25d0da5 68788-0547 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20130222 ANDA ANDA075562 Preferred Pharmaceuticals, Inc IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68788-0575_d8f2d888-f5b8-4acb-afb0-342addfa38c5 68788-0575 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19991229 ANDA ANDA074112 Preferred Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 68788-0597_50d0f445-149c-4c0d-8a27-fff560c84e83 68788-0597 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate CREAM TOPICAL 20141126 ANDA ANDA070050 Preferred Pharmaceuticals, Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-0598_51d79d1d-58d8-4be9-af75-d81f44d5e275 68788-0598 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20110331 ANDA ANDA065191 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-0600_5a3becf4-1ec9-4156-a637-8314f8da86f2 68788-0600 HUMAN PRESCRIPTION DRUG Thermazene Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 20130904 NDA NDA018810 Preferred Pharmaceuticals, Inc. SILVER SULFADIAZINE 10 mg/g N 20181231 68788-0603_cf8a3ce1-f9a7-4417-85e7-27da4c4f9d5a 68788-0603 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20091001 ANDA ANDA071587 Preferred Pharmaceuticals, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 68788-0616_f1f70a31-8e98-4121-86e3-7e2a16e6fac9 68788-0616 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20130919 ANDA ANDA065442 Preferred Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68788-0617_2c0ee6a2-696d-48c5-95d7-9a52690513dd 68788-0617 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxaxin SOLUTION/ DROPS AURICULAR (OTIC) 20130322 ANDA ANDA076616 Preferred Pharmaceuticals, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-0625_ab3f3c19-206c-405a-a79d-98c547084835 68788-0625 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20130926 ANDA ANDA090529 Preferred Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 68788-0633_8d573eae-c098-4376-8137-7cbba4308166 68788-0633 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20130314 ANDA ANDA064048 Preferred Pharmaceuticals, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 68788-0636_fd294393-e5a2-40a4-a16b-e692aaf2df60 68788-0636 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20170705 NDA NDA014901 Preferred Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-0645_586aacd1-d387-4a66-a61b-bc765020d433 68788-0645 HUMAN OTC DRUG hydrocortisone hydrocortisone OINTMENT TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. HYDROCORTISONE 1 g/100g N 20181231 68788-0678_9ff8d4e5-cc96-4f5f-95ab-b7d2be2663f8 68788-0678 HUMAN OTC DRUG Regular Strength Enteric coated aspirin Aspirin TABLET, COATED ORAL 20151007 OTC MONOGRAPH FINAL part343 Preferred Pharmaceuticals Inc. ASPIRIN 325 mg/1 N 20181231 68788-0681_2f5d3988-e004-4c55-9659-4ba724a43d5d 68788-0681 HUMAN PRESCRIPTION DRUG METHIMAZOLE METHIMAZOLE TABLET ORAL 20140227 ANDA ANDA202068 Preferred Pharmaceuticals, Inc. METHIMAZOLE 10 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] E 20171231 68788-0686_1729f116-8384-4ea1-b7b8-e0f2e0573105 68788-0686 HUMAN PRESCRIPTION DRUG Diethylpropion HCl Controlled-Release Diethylpropion hydrochloride TABLET ORAL 20140212 NDA NDA012546 Preferred Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68788-0708_e75a710e-b577-4b87-95a4-410105a84d38 68788-0708 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20141020 ANDA ANDA065392 Preferred Pharmaceuticals, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-0713_8759c058-2f47-4c61-afc3-cdbf4c52ed79 68788-0713 HUMAN PRESCRIPTION DRUG azithromycin AZITHROMYCIN POWDER, FOR SUSPENSION ORAL 19990212 NDA NDA050693 Preferred Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 1 g/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-0715_f1d500d6-fbe8-4454-b365-53d5ef591795 68788-0715 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir SUSPENSION ORAL 20110318 ANDA ANDA077026 Preferred Pharmaceuticals, Inc ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 68788-0736_9a621253-7dd4-4fc9-a600-2a4996a066e0 68788-0736 HUMAN PRESCRIPTION DRUG Proparacaine Hydrochloride Proparacaine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20140428 ANDA ANDA040074 Preferred Pharmaceuticals, Inc. PROPARACAINE HYDROCHLORIDE 5 mg/mL Local Anesthesia [PE],Local Anesthetic [EPC] N 20181231 68788-0748_9970b3e1-484a-4c49-a56d-2ef9ffac3d07 68788-0748 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20110609 ANDA ANDA040218 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-0758_43c2c750-b28f-4a5c-98ef-9d461ad7dda7 68788-0758 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20140203 OTC MONOGRAPH FINAL part332 Preferred Pharmaceuticals, Inc. DIMETHICONE 410 180 mg/1 N 20181231 68788-0763_ac9ed4f5-ae21-48ab-a01f-b7478f2212f0 68788-0763 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, COATED ORAL 20110518 ANDA ANDA065255 Preferred Pharmaceuticals, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-0768_e082d783-793f-4c17-b124-04fe377fb272 68788-0768 HUMAN PRESCRIPTION DRUG CELEBREX Celecoxib CAPSULE ORAL 20140820 NDA NDA020998 Preferred Pharmaceuticals, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68788-0790_a0298853-6816-42cf-8191-77912ede098b 68788-0790 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Preferred Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 68788-0797_2e498d1c-964b-4349-8c90-c33befeb39d1 68788-0797 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Preferred Pharmaceuticals, Inc PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-0802_4db7f9f4-f5df-4a75-a6a6-04a2b76a30aa 68788-0802 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20130326 ANDA ANDA078216 Preferred Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-0816_a6cdfd0e-a3f2-4b9d-adab-8104099dab24 68788-0816 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20101007 ANDA ANDA078938 Preferred Pharmaceuticals, Inc TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68788-0825_1b664106-570f-447e-8a3d-106f4a161a45 68788-0825 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 20110603 ANDA ANDA074749 Preferred Pharmaceuticals, inc ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] E 20171231 68788-0839_4a87f6e7-becf-4951-8f02-64e1f9a86ad5 68788-0839 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr and Guiafenesin TABLET, FILM COATED ORAL 20090212 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 68788-0845_7957f9da-fbb5-410a-8b82-8a766ee8fb8c 68788-0845 HUMAN OTC DRUG Sinus Congestion PE Guaifenesin and Phenylephrine HCl TABLET ORAL 20140514 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 E 20171231 68788-0852_6c130ae2-6aca-4264-95e3-dc820abb311c 68788-0852 HUMAN OTC DRUG Q-Tapp DM Elixir Brompheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide ELIXIR ORAL 20010405 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 1; 15; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 68788-0881_b22d36c8-d346-4853-a73e-fb653231ed3a 68788-0881 HUMAN PRESCRIPTION DRUG Skelaxin Metaxalone TABLET ORAL 20030130 NDA NDA013217 Preferred Pharmaceuticals, Inc METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] E 20171231 68788-0920_dc8e9a8f-fe4e-4a99-84a1-d716cb09e428 68788-0920 HUMAN PRESCRIPTION DRUG Tetracaine Hydrochloride Tetracaine Hydrochloride SOLUTION OPHTHALMIC 20130516 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. TETRACAINE HYDROCHLORIDE 5 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 68788-0926_830d083a-d6e2-41fb-bb5c-695a05c216db 68788-0926 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130318 ANDA ANDA075828 Preferred Pharmaceuticals, Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-0972_77d93924-f904-4310-b07d-d215286c6417 68788-0972 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 19870203 ANDA ANDA071012 Preferred Pharmaceuticals, Inc BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-0985_36418db0-63c5-4431-8e99-19f2f3c406c0 68788-0985 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Preferred Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 68788-0999_cadeb5b8-985a-452a-ad2e-bffaaea94ca9 68788-0999 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA076649 Preferred Pharmaceuticals, Inc CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 68788-1473_8f055247-c404-49b7-bdd6-027c0861ffd3 68788-1473 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130619 ANDA ANDA085162 Preferred Pharmaceuticals, Inc. PREDNISONE 10 mg/1 N 20181231 68788-1554_b4e1dece-8213-4f7e-a504-936eb6c9fdc5 68788-1554 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20131118 ANDA ANDA075576 Preferred Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-1701_10975dd6-514a-4ce9-8744-5d6c88af39c3 68788-1701 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20130315 ANDA ANDA077927 Preferred Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68788-1737_caf2d986-d9b8-4ca2-bdb9-8d3a8fc6a176 68788-1737 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Preferred Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-1738_caf2d986-d9b8-4ca2-bdb9-8d3a8fc6a176 68788-1738 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20100407 ANDA ANDA078414 Preferred Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-1966_ed3a1863-a8ef-4325-bf30-b8fd8e9a4ba7 68788-1966 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20130320 NDA NDA018823 Preferred Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 68788-2027_d8f2d888-f5b8-4acb-afb0-342addfa38c5 68788-2027 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19991229 ANDA ANDA074112 Preferred Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 68788-2029_d8f2d888-f5b8-4acb-afb0-342addfa38c5 68788-2029 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19991229 ANDA ANDA074112 Preferred Pharmaceuticals, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 68788-2112_881eaeed-2640-4e32-b33d-abe1e09487b7 68788-2112 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20131217 ANDA ANDA062269 Preferred Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68788-2115_cf8a3ce1-f9a7-4417-85e7-27da4c4f9d5a 68788-2115 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20091001 ANDA ANDA071586 Preferred Pharmaceuticals, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 68788-2212_9970b3e1-484a-4c49-a56d-2ef9ffac3d07 68788-2212 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20110609 ANDA ANDA040218 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-2213_9970b3e1-484a-4c49-a56d-2ef9ffac3d07 68788-2213 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20110609 ANDA ANDA040218 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-2518_1db6264d-6bde-44bc-8c36-05fea3dfe9b6 68788-2518 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20140113 ANDA ANDA077253 Preferred Pharmaceuticals, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68788-2582_1a0a91cf-b48e-4e6d-a582-4d26975e19da 68788-2582 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20110615 ANDA ANDA040245 Preferred Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 68788-2634_830d083a-d6e2-41fb-bb5c-695a05c216db 68788-2634 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130318 ANDA ANDA075828 Preferred Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-3768_80fb25c1-46f6-4179-857f-89b6c94372f3 68788-3768 HUMAN PRESCRIPTION DRUG Budesonide Inhalation Budesonide SUSPENSION RESPIRATORY (INHALATION) 20150817 ANDA ANDA078404 Preferred Pharmaceuticals Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-4593_ebe4f4a5-3fec-4f30-8289-25e594162c49 68788-4593 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 20130903 ANDA ANDA040189 Preferred Pharmaceuticals, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68788-5665_893f8f02-4d36-49fc-9476-05e3c73db116 68788-5665 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120329 ANDA ANDA075022 Preferred Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 68788-5928_7c59f4be-f814-4952-864a-628076200cab 68788-5928 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20140115 ANDA ANDA087022 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68788-6317_944a843d-99dc-4fbf-a63e-7731322d2db6 68788-6317 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride Olopatadine Hydrochloride 0.1% SOLUTION/ DROPS OPHTHALMIC 20170327 ANDA ANDA204706 Preferred Pharmaceuticals Inc. OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 68788-6319_9daea033-55d8-46eb-8612-f39329ea0e2c 68788-6319 HUMAN PRESCRIPTION DRUG lidocaine lidocaine OINTMENT TOPICAL 20161010 ANDA ANDA206498 Preferred Pharmaceuticals Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 68788-6320_477cd6c7-b667-4666-bec2-4c5aa1c5ad05 68788-6320 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20161010 ANDA ANDA202446 Preferred Pharamaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-6321_90dad633-5c78-4105-893f-babbd71ac747 68788-6321 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20161010 ANDA ANDA079170 Preferred Pharmaceuticals Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6322_18eff798-b751-4cde-b774-48be80cfdca1 68788-6322 HUMAN PRESCRIPTION DRUG Naproxen delayed release Naproxen TABLET ORAL 20161010 ANDA ANDA091432 Preferred Pharmaceuticals Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68788-6323_77a305b0-2a51-4c3f-8537-cae50106a7e8 68788-6323 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20161017 ANDA ANDA203154 Preferred Pharmaceuticals Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 68788-6324_8dddab80-2f45-4c45-8fde-838ef9570e66 68788-6324 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET ORAL 20161018 ANDA ANDA202928 Preferred Pharmaceuticals Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68788-6325_1f8b9aad-f31f-4cda-861d-c08a977fc923 68788-6325 HUMAN PRESCRIPTION DRUG Tri-Sprintec norgestimate and ethinyl estradiol KIT 20161018 ANDA ANDA075808 Preferred Pharmaceuticals Inc. E 20171231 68788-6326_bc09e25b-ec1f-419e-b611-6bf58c6a9cbd 68788-6326 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20161018 ANDA ANDA090074 Preferred Pharmaceuticals Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68788-6327_f48ef7bf-1377-44dd-af49-f9d5dda00003 68788-6327 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20161017 ANDA ANDA076939 Preferred Pharmaceuticals Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6328_af948f1b-e9e6-434e-b153-b6eba0f24474 68788-6328 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161017 ANDA ANDA090700 Preferred Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-6329_3425ea81-6d50-48f8-b0b5-dd8175407a1a 68788-6329 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20161017 ANDA ANDA091629 Preferred Pharmaceuticals Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-6330_8e738dc9-691c-48d9-a3a5-23c85146a7d8 68788-6330 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20161017 ANDA ANDA204019 Preferred Pharmaceuticals Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68788-6331_1e3f2b3e-f268-4c6d-bbec-de465d017632 68788-6331 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 Preferred Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6332_821e8299-90cf-4316-8911-10f48e2c717f 68788-6332 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 20161017 ANDA ANDA089424 Preferred Pharmaceuticals Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68788-6333_bb5c3b6b-419d-4a47-9fa6-a1d71c09804c 68788-6333 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20161017 ANDA ANDA091497 Preferred Pharmaceuticals Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-6335_67cb5510-b7db-46a4-a8f8-608b9da86f62 68788-6335 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20161017 ANDA ANDA086724 Preferred Pharmaceuticals Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 68788-6336_c450d723-cf0b-4a7e-9fd5-67af8d9e6da5 68788-6336 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20161017 ANDA ANDA202764 Preferred Pharmaceuticals Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-6337_a09cfb32-e5a7-4f47-b1d9-430dfcc0309b 68788-6337 HUMAN OTC DRUG Pedia Relief Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID ORAL 20161017 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals Inc. CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 1; 15; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 68788-6339_529cec84-83c4-446c-813a-e238b5b4548c 68788-6339 HUMAN PRESCRIPTION DRUG MARLISSA Levonorgestrel and Ethinyl Estradiol KIT 20161017 ANDA ANDA091452 Preferreed Pharmaceuticals Inc. N 20181231 68788-6340_318ca2a6-e2f0-446d-b079-03694aed7a14 68788-6340 HUMAN OTC DRUG Mucinex DM Guaifenesin and Dextromethorphan Hydrobromide TABLET, EXTENDED RELEASE ORAL 20161017 NDA NDA021620 Preferred Pharmaceuticals Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 600; 30 mg/1; mg/1 N 20181231 68788-6341_e6fbc34a-9fbd-4f31-a81c-c703c5ea9537 68788-6341 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20161017 ANDA ANDA091624 Preferred Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6342_c0955c54-9cdc-4126-b9a7-6c8e6ccc397b 68788-6342 HUMAN PRESCRIPTION DRUG Gentamicin Sulfate Gentamicin Sulfate SOLUTION/ DROPS OPHTHALMIC 20161013 ANDA ANDA064163 Preferred Pharamcaeuticals Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 68788-6343_e6eb75d4-f958-42ce-864d-b59a784fadaf 68788-6343 HUMAN OTC DRUG Calcium Carbonate (Antacid) Calcium Carbonate TABLET ORAL 20161024 OTC MONOGRAPH FINAL part331 Preferred Pharmaceuticals Inc. CALCIUM CARBONATE 648 mg/1 N 20181231 68788-6345_4e4db768-ec7f-40c2-8d7a-a37cb901ccfc 68788-6345 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20161024 ANDA ANDA077135 Preferred Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 1000 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68788-6350_112d2860-ce6e-41c2-93fa-8776d022841a 68788-6350 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20160302 ANDA ANDA072488 Preferred Pharmaceuticals Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-6351_88f8c6ae-64cc-435d-af25-ad8374bee854 68788-6351 HUMAN OTC DRUG triple antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20160301 OTC MONOGRAPH FINAL part333B Preferred Pharmaceuticals Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 68788-6352_ac874d0e-741c-442c-a47c-48dd1db04055 68788-6352 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE and ACETAMINOPHEN SOLUTION ORAL 20160314 ANDA ANDA040838 Preferred Pharmaceuticals Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/15mL; mg/15mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 68788-6353_eaea8c49-c1e5-4711-8817-dadac6063579 68788-6353 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20160302 NDA NDA021342 Preferred Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-6354_e78ca0d6-7c7d-4192-84fa-a922881b6f2e 68788-6354 HUMAN OTC DRUG Rugby Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20160301 OTC MONOGRAPH FINAL part349 Preferred Pharmaceuticals Inc. POLYVINYL ALCOHOL 14 mg/mL E 20171231 68788-6357_a305751b-7639-48e8-bbfa-0c37e39ccdc8 68788-6357 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20160301 ANDA ANDA040597 Preferred Pharmaceuticals Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68788-6358_837365ca-338b-42f7-8639-997f5b0f7d78 68788-6358 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20160301 ANDA ANDA074174 Preferred Pharmaceuticals, Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-6359_580f6b51-4df9-4559-9439-af99da0158de 68788-6359 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20160314 NDA NDA021342 Preferred Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-6360_7a61a532-66a8-4a48-a6ba-894ccf8ccc19 68788-6360 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20160314 ANDA ANDA077309 Preferred Pharmaceuticals Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 68788-6361_a5bd7ca6-bc5a-4ca2-a7f4-d2520e6a215e 68788-6361 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20160315 ANDA ANDA076402 Preferred Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-6364_7e8a0620-2be3-4b0e-b5a1-d9d5f7d91d79 68788-6364 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20160316 ANDA ANDA076265 Preferred Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-6365_fb4a58f1-9188-4a9a-bd2b-f7150046ace1 68788-6365 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20160316 ANDA ANDA076416 Preferred Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68788-6366_1f09784a-252c-441b-8366-391fab791ac8 68788-6366 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Preferred Pharmaceuticalc Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-6367_a7eb152a-25d9-4ea4-82f6-190be129fc0a 68788-6367 HUMAN PRESCRIPTION DRUG Lasix Furosemide TABLET ORAL 20160408 ANDA ANDA077293 Preferred Pharmaceuticals Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68788-6368_56c8cef1-6ecf-44aa-8889-807e2b226a65 68788-6368 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20160411 ANDA ANDA202769 Preferred Pharmcacuticals Inc. DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6369_cf6145f1-a9ae-44e7-ab37-9889ceb94185 68788-6369 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20160411 ANDA ANDA065271 Preferred Pharmaceuticals Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-6371_9fbafed2-e364-4ce2-994e-2a06683e0b99 68788-6371 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20160412 ANDA ANDA077321 Preferred Pharmaceuticals Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-6372_f8a48083-2d58-491f-9958-3e0f0b288df9 68788-6372 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20160412 ANDA ANDA040865 Preferred Pharmaceuticals Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 68788-6373_2ccb4597-f4cc-4469-aab0-2dbae3cbf7e7 68788-6373 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160412 ANDA ANDA202554 Preferred Pharmaceuticals Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-6374_85735bf2-61fa-4704-b473-461fe6ba9fa0 68788-6374 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20160413 ANDA ANDA064076 Preferred Pharmaceuticals Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-6375_1f8742f3-bee4-4687-8cd5-1f4a9502700d 68788-6375 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20160413 ANDA ANDA077797 Preferred Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 68788-6376_9a010290-186a-4182-a6bd-c6ae75b3cbeb 68788-6376 HUMAN PRESCRIPTION DRUG epinephrine epinephrine INJECTION SUBCUTANEOUS 20160414 NDA AUTHORIZED GENERIC NDA020800 Preferred Pharmaceuticals Inc. EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] E 20171231 68788-6377_09667780-d9fc-4bf3-9b91-34e78034fb74 68788-6377 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20160414 ANDA ANDA090278 Preferred Pharmaceuticals Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-6378_249d835a-6d32-49fd-9bf5-43f51c639f5c 68788-6378 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20160414 ANDA ANDA203814 Preferred Pharmaceuticals Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 68788-6379_2b8ed5e1-6f91-457a-bcc5-fdbf432558dc 68788-6379 HUMAN PRESCRIPTION DRUG valacyclovir hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20160427 ANDA ANDA201506 Preferred Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68788-6380_ae233f7f-b05c-4911-b2e2-15704c9ffdd4 68788-6380 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20160504 ANDA ANDA203088 Preferred Pharmaceuticals Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6381_bde409cb-935d-492d-a1aa-71599c88953f 68788-6381 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20160428 ANDA ANDA074174 Preferred Pharmaceuticals Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-6382_21bf6427-4c5c-4d70-90ad-071366761146 68788-6382 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20160504 ANDA ANDA078542 Preferred Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68788-6384_72b21f0c-cd2c-4798-9ba0-c1406db6f710 68788-6384 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20160504 ANDA ANDA077241 Preferred Pharmaceuticals Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68788-6385_aa0fe47e-9ba3-45bb-82bd-b2435e81140c 68788-6385 HUMAN OTC DRUG Rugby Eye Irrigating Purified Water SOLUTION/ DROPS OPHTHALMIC 20160504 OTC MONOGRAPH FINAL part349 Preferred Pharmaceuticals Inc. WATER 99.05 mL/100mL N 20181231 68788-6386_ce894f35-8942-443b-80ef-46353d2fa3c2 68788-6386 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20160504 ANDA ANDA077073 Preferred Pharmaceuticals Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 68788-6388_7e0b7b56-e497-4158-8f17-a5042a71836b 68788-6388 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160505 ANDA ANDA075492 Preferred Pharmaceuticals Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6389_60bbe73a-22bd-48ca-a063-625c79b9797b 68788-6389 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20160520 ANDA ANDA090331 Preferred Pharmaceuticals Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68788-6390_adf49567-6866-4de2-b54e-12d598af9103 68788-6390 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20160520 ANDA ANDA091269 Preferred Pharmaceuticals Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68788-6391_1ad2d628-b6a7-4427-ae40-14b619681abe 68788-6391 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20160523 ANDA ANDA090200 Preferred Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-6392_adfc9efb-5b7b-473b-b9ed-37ec7b6c00e8 68788-6392 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 20160504 ANDA ANDA070994 Preferred Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-6393_9d08dc60-07c8-4e22-80bb-7a194231bfc4 68788-6393 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20160523 ANDA ANDA207446 Preferred Pharmaceuticals Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6394_7fd3676e-a36b-4a05-94d4-e000af0952e2 68788-6394 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET ORAL 20160524 ANDA ANDA079128 Preferred Pharmaceuticals Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 68788-6396_b9e0536f-3575-4c19-9771-c1806bc23351 68788-6396 HUMAN PRESCRIPTION DRUG Flector Diclofenac Epolamine PATCH TOPICAL 20160531 NDA NDA021234 Preferred Pharmaceucitalc Inc. DICLOFENAC EPOLAMINE 180 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68788-6397_50612922-b79b-4d8b-a39d-7e31f7ee9ebd 68788-6397 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20160524 ANDA ANDA077293 Preferred Pharmaceuticals Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68788-6398_773f0b42-ec8f-4465-830c-a1058e48e861 68788-6398 HUMAN PRESCRIPTION DRUG Pravastatin sodium Pravastatin sodium TABLET ORAL 20160531 ANDA ANDA076939 Preferred Pharmaceuticals Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6399_322fbf5d-a677-4f02-b77a-1d03537d3514 68788-6399 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20160531 ANDA ANDA075511 Preferred Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68788-6400_6bb95d5c-75f4-46f0-a4d5-641b9806c4b4 68788-6400 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20160531 ANDA ANDA073516 Preferred Pharmaceuticals Inc. KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6401_4c70c5c4-2009-441a-a5fc-c6b173627db0 68788-6401 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20160601 ANDA ANDA063029 Preferred Pharmaceuticals Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68788-6402_53113e1a-5108-4f9c-978d-701ded14eab3 68788-6402 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 20160609 ANDA ANDA075079 Preferred Pharmaceuticals Inc. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 68788-6403_de93e91d-f1fd-4df9-a672-36180ec795da 68788-6403 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20160609 ANDA ANDA076765 Preferred Pharmaceuticals Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6404_b74d5071-9fd7-470e-8eb1-32cd4e4e0fd6 68788-6404 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20160609 ANDA ANDA040230 Preferred Pharmaceuticals Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68788-6405_bc6ded3a-3f71-44c4-8094-e2e8f5c840d9 68788-6405 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20160609 ANDA ANDA203835 Preferred Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-6406_9c2016f7-96e9-431f-80f9-201d42177485 68788-6406 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20160609 ANDA ANDA074661 Preferred Pharmaceuticals Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 68788-6407_3e92548b-fc25-4aae-9d7b-c28ced037dd4 68788-6407 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160610 ANDA ANDA076180 Preferred Pharmaceuticals Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-6408_4f218390-1f7f-4966-90d8-d939c8281eee 68788-6408 HUMAN OTC DRUG Pharbetol Acetaminophen TABLET ORAL 20160608 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 68788-6409_871f970e-98e3-46be-aead-8d4c359a7f2f 68788-6409 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20160608 ANDA ANDA090455 Preferred Pharmaceuticals Inc. ERGOCALCIFEROL 1.25 1/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 68788-6410_b236cb89-e463-431c-b29e-903590e57075 68788-6410 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20160608 ANDA ANDA202096 Preferred Pharmaceuticals Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68788-6411_490ba259-d5e5-46ca-9301-bd7113225654 68788-6411 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20160610 ANDA ANDA078181 Preferred Pharmaceuticals Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68788-6413_700ebb12-9799-4b50-9f2c-1d20591438a1 68788-6413 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160610 ANDA ANDA071135 Preferred Pharmaceuticals Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-6414_7b6a68b4-4910-4ee0-9d10-a304a1288925 68788-6414 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20160617 ANDA ANDA040256 Preferred Pharmaceuticals Inc. PREDNISONE 10 mg/1 N 20181231 68788-6416_ef5f4a03-0807-4de7-9b5b-45f8041c708e 68788-6416 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20160615 ANDA ANDA065352 Preferred Pharmaceuticals Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-6417_15ff0866-fc52-4c92-9752-538b5aebf4f0 68788-6417 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20160615 ANDA ANDA090278 Preferred Pharmaceuticals Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-6418_a3c1ac39-68a4-485e-83e0-c5f222eb5917 68788-6418 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160614 ANDA ANDA202554 Preferred Pharmaceuticals Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-6419_ea53d544-d521-46bd-93d5-76b00002da1a 68788-6419 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20160614 ANDA ANDA200044 Preferred Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 68788-6420_64d775dd-951f-4f2f-ae43-758807c084ed 68788-6420 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride Pioglitazone Hydrochloride TABLET ORAL 20160614 ANDA ANDA076798 Preferred Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 68788-6421_257cf73c-45d9-4b66-8a81-b270d3f083c8 68788-6421 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20160614 ANDA ANDA075927 Preferred Pharmaceuticals Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6422_28d0ba44-b3e6-4f5c-8cbf-cf5c72d681ca 68788-6422 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20160614 ANDA ANDA018659 Preferred Pharmaceuticals Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 68788-6424_58d5c176-d76c-4e76-bd44-c48204eb971a 68788-6424 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160620 ANDA ANDA090174 Preferred Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6425_ac9c4a36-491f-4b70-8c79-3e2b78c1272d 68788-6425 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20160615 ANDA ANDA065136 Preferred Pharmaceuticals Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-6426_1b906c9c-f5d9-426c-9bed-7b746d3d69df 68788-6426 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20160620 ANDA ANDA077870 Preferred Pharmaceuticals Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-6427_ce516b67-fc3e-43f4-85e6-eb512c20cfd2 68788-6427 HUMAN PRESCRIPTION DRUG duloxetine duloxetine CAPSULE, DELAYED RELEASE ORAL 20160621 ANDA ANDA202336 Preferred Pharmaceuticals Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6428_114fc0dc-38cb-428c-8047-242acbaaeedc 68788-6428 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20160628 ANDA ANDA086724 Preferred Pharmaceuticals Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 68788-6429_9f587b8f-c661-4f1c-a955-d5ba27c87fcc 68788-6429 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20160628 ANDA ANDA077206 Preferred Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6430_46a402eb-d9e5-49db-b5e8-57ec1fa79002 68788-6430 HUMAN PRESCRIPTION DRUG Lidocaine lidocaine OINTMENT TOPICAL 20160628 ANDA ANDA205318 Preferred Pharmaceuticals Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 68788-6431_eed6609b-23c7-4a74-8de5-05fd97c4f339 68788-6431 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride TABLET ORAL 20160628 ANDA ANDA076280 Preferred Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68788-6432_fc239648-4007-42d0-9980-a0b67675aaa4 68788-6432 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20160629 ANDA ANDA202446 Preferred Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-6434_651e6b07-0200-4687-8f1b-4ab0ce191c74 68788-6434 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine lidocaine and prilocaine CREAM TOPICAL 20160629 ANDA ANDA076453 Preferred Pharmaceuticals Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 68788-6435_81370248-8c82-4a95-9c5c-e7628d8d7c48 68788-6435 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20160711 ANDA ANDA079162 Preferred Pharmaceuticals, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-6436_1c52464e-c99e-40cc-abf0-6b358afeb684 68788-6436 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20160711 ANDA ANDA078181 Preferred Pharmaceuticals Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68788-6437_dc65bd76-f36a-47e1-96a3-d8093b718cbc 68788-6437 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20160725 ANDA ANDA077206 Preferred Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6438_84ae06f7-00bb-443b-84ce-345dd6a76c26 68788-6438 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160720 ANDA ANDA090705 Preferred Pharmaceuticals Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-6439_f446df60-9e5d-4b0f-9ab4-148094c3e99a 68788-6439 HUMAN OTC DRUG Earwax Treatment Drops Carbamide Peroxide SOLUTION AURICULAR (OTIC) 20160720 OTC MONOGRAPH FINAL part344 Preferred Pharmaceuticals Inc. CARBAMIDE PEROXIDE 81.86 mg/mL N 20181231 68788-6440_0e0166d9-5727-421b-88f6-d8299a43b447 68788-6440 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20170221 ANDA ANDA040362 Preferred Pharmaceuticals Inc. PREDNISONE 10 mg/1 N 20181231 68788-6441_7f814011-1667-4145-90c5-dfa753618a22 68788-6441 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20160725 ANDA ANDA062505 Preferred Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68788-6442_2efe9976-acb6-4e10-91ca-f676700b7cd6 68788-6442 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 20160729 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals Inc. SENNOSIDES A AND B 8.6 mg/1 N 20181231 68788-6444_78231dab-1536-4190-ba24-78f376b28004 68788-6444 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20160801 ANDA ANDA076416 Preferred Pharmaceuticals Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68788-6445_33a690b2-3629-4fb7-b3aa-a2046978f201 68788-6445 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20160801 ANDA ANDA078243 Preferred Pharmaceuticals Inc LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-6446_aea3749d-6265-4670-9620-d55f050741fd 68788-6446 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20160816 ANDA ANDA077739 Preferred Pharmaceuticals Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6447_c7de5f9a-7d7e-4a87-b3b6-c561a3ac313e 68788-6447 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20160802 ANDA ANDA077836 Preferred Pharmaceuticals Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 68788-6448_89aede8b-3208-42fd-a3fa-55ca2833ced6 68788-6448 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20160805 ANDA ANDA091276 Preferred Pharmaceuticals Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6449_7b87e85b-96f4-4ce0-980e-168e9140a94b 68788-6449 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20160805 ANDA ANDA077917 Preferred Pharmaceuticals Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6450_8eb5a6d1-8776-406d-b934-3db3044234cb 68788-6450 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20160802 ANDA ANDA074056 Preferred Pharmaceuticals Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6451_b0506e24-3c44-4114-a8db-a3afb9c11dc9 68788-6451 HUMAN OTC DRUG Meclizine HCL 25 mg Meclizine HCL TABLET ORAL 20160805 OTC MONOGRAPH FINAL part336 Preferred Pharmaceuticals Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 68788-6452_f5c2d794-fd60-4c03-ae92-968bb47e0e99 68788-6452 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20160805 ANDA ANDA091629 Preferred Pharmaceuticals Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-6453_f19629ec-5907-49c8-828b-cadd2f1c93ce 68788-6453 HUMAN PRESCRIPTION DRUG Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide SYRUP ORAL 20160805 ANDA ANDA205292 Preferred Pharmaceuticals Inc. BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 2; 30; 10 mg/5mL; mg/5mL; mg/5mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] N 20181231 68788-6454_c30288f5-f849-4b8c-bfcc-b46bd8f4bae4 68788-6454 HUMAN PRESCRIPTION DRUG Nitrofurantoin monohydrate macrocrystals Nitrofurantoin monohydrate macrocrystals CAPSULE ORAL 20160809 ANDA ANDA202250 Preferred Pharmaceuticals Inc. NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 68788-6456_a63239f4-f9a2-41e7-a669-9e9b6c36a271 68788-6456 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160809 ANDA ANDA077118 Preferred Pharmaceuticals Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6457_de30e5b4-409c-487c-a51c-1a0c4e75b191 68788-6457 HUMAN OTC DRUG Biofreeze MENTHOL GEL TOPICAL 20160816 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals Inc. MENTHOL, UNSPECIFIED FORM 40 mg/mL N 20181231 68788-6458_d1e75093-0dac-483d-a79e-31a7393c070c 68788-6458 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20160817 ANDA ANDA076900 Preferred Pharmaceuticals Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6459_fc182143-2a70-4a41-941f-287803a2ee8f 68788-6459 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20160817 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals Inc. IBUPROFEN 200 mg/1 N 20181231 68788-6460_9e3224a9-11a4-42f8-8d09-4237a93e8786 68788-6460 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20160815 ANDA ANDA063083 Preferred Pharmaceuticals Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68788-6461_8ae4a0c1-1424-47a9-9a59-7fe38bedc0c7 68788-6461 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160816 ANDA ANDA075350 Preferred Pharmaceuticals Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 68788-6462_3e218094-c751-42b8-9b40-2413a6748f5d 68788-6462 HUMAN PRESCRIPTION DRUG Losartan Potassium losartan potassium TABLET, FILM COATED ORAL 20160815 ANDA ANDA091497 Preferred Pharmaceuticals, Inc LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-6463_eab9eebc-577b-484e-ba5d-60f9c7771b35 68788-6463 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20160816 ANDA ANDA206827 Preferred Pharmaceuticals Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6465_3dd3a8ff-697c-4cd9-a3bf-da517bdca3fd 68788-6465 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160816 ANDA ANDA091065 Preferred Pharmaceuticals Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 68788-6466_fe174715-8543-46b7-910a-b750299adf23 68788-6466 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20160802 ANDA ANDA040445 Preferred Pharmaceuticals Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 68788-6755_63eea2b9-bea1-4347-a6ed-222d5f749d86 68788-6755 HUMAN OTC DRUG MEDROX MENTHOL, CAPSAICIN PATCH TOPICAL 20120727 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. MENTHOL, UNSPECIFIED FORM; CAPSAICIN 5; .0375 g/100g; g/100g N 20181231 68788-6759_d6d9b925-4af4-4457-8e51-427ca8e3a2b0 68788-6759 HUMAN OTC DRUG Diabetic Siltussin DAS-Na Guaifenesin LIQUID ORAL 20120724 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals Inc. GUAIFENESIN 100 mg/5mL N 20181231 68788-6760_c893ccef-d5b3-42aa-8696-851f8b4b093b 68788-6760 HUMAN OTC DRUG Diabetic Siltussin DM DAS-Na Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 20120724 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 68788-6761_f41b9c02-9dd4-403f-a75c-a0b291daf113 68788-6761 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20120726 ANDA ANDA078955 Preferred Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6762_f41b9c02-9dd4-403f-a75c-a0b291daf113 68788-6762 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20120726 ANDA ANDA078955 Preferred Pharmaceuticals, Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6763_7c7443de-ad12-45f5-b439-c668ab5ae9fb 68788-6763 HUMAN PRESCRIPTION DRUG Promethazine VC Promethazinehydrochloride and phenylephrine hydrochloride SYRUP ORAL 20120725 ANDA ANDA040654 Preferred Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 5 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] E 20171231 68788-6766_336943f3-b422-44b8-bb23-6151d7e58276 68788-6766 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine Maleate TABLET ORAL 20120726 ANDA ANDA040268 Preferred Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68788-6767_5d920736-6c55-444c-9b9c-d76a782fdcaa 68788-6767 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20120725 ANDA ANDA200272 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68788-6769_7fa4b86c-4fb2-4c83-b6f9-e537b3545910 68788-6769 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20161024 ANDA ANDA078327 Preferred Pharmaceuticals Inc. SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68788-6770_7c722b9b-6ea9-460c-ae5c-c6978a54cb78 68788-6770 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20161024 ANDA ANDA090278 Preferred Pharmaceuticals Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-6771_5376ff11-a428-41e7-979b-f0af537ac926 68788-6771 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161024 NDA AUTHORIZED GENERIC NDA018279 Preferred Pharmaceuticals Inc. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68788-6772_8c387a4f-a1d1-4dcf-aacd-b15654caf4af 68788-6772 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20161024 ANDA ANDA076368 Preferred Pharmaceuticals Inc. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 68788-6773_cfe475e5-2b47-4f6d-9048-efa51e0d88eb 68788-6773 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20161024 ANDA ANDA203126 Preferred Pharmaceuticals, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-6774_fa677606-9e0f-4885-8db6-199d2fbb4832 68788-6774 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20161024 ANDA ANDA090568 Preferred Pharmaceuticals, Inc. ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 68788-6775_8654912d-5c9f-4d2f-9311-2b3aaa20beab 68788-6775 HUMAN PRESCRIPTION DRUG Bisoprolol Fumarate Bisoprolol fumarate TABLET ORAL 20161024 ANDA ANDA078635 Preferred Pharmaceuticals, Inc. BISOPROLOL FUMARATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6776_7736ca63-e104-454d-9780-26ebd50bb151 68788-6776 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20161024 ANDA ANDA076447 Preferred Pharmaceuticals, Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 68788-6777_8d872133-7309-49ae-9e71-adc550c5fe02 68788-6777 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION RESPIRATORY (INHALATION) 20161024 ANDA ANDA090297 Preferred Pharmaceuticals, Inc. LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68788-6778_075f9fd2-481a-4314-a64a-04b0fe6ccee2 68788-6778 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20161024 ANDA ANDA078327 Preferred Pharmaceuticals, Inc. SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68788-6779_d5a82875-e84c-46b6-b55a-4f11465a9603 68788-6779 HUMAN PRESCRIPTION DRUG Prenatal Plus Vitamin A, Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Iron, Zinc Oxide, and Cupric Oxide TABLET ORAL 20161025 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. VITAMIN A; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; IRON; ZINC OXIDE; CUPRIC OXIDE 4000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 29; 25; 2 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 68788-6780_b8b4e5f6-4c5c-47d0-ad84-9e2a9803f298 68788-6780 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20161025 ANDA ANDA201991 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-6781_ede5f892-95b9-4b35-856a-0001ed2e1af4 68788-6781 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20161025 ANDA ANDA203245 Preferred Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-6782_4917e29d-bd04-4eb1-9cb8-c354f4da31f5 68788-6782 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20161025 ANDA ANDA202554 Preferred Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-6783_a791e85d-2f10-4b1a-acd0-a724b6bc1915 68788-6783 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20161025 ANDA ANDA202389 Preferred Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6784_6e212d11-11c5-4173-a2ff-fb3a68479172 68788-6784 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20161025 ANDA ANDA077293 Preferred Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68788-6785_de32219e-0a92-417a-8d3b-962d83e656d4 68788-6785 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161102 ANDA ANDA077298 Preferred Pharmaceuticals, Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6786_96317acc-a6d9-4b1c-b3e7-c79cb139d598 68788-6786 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20161102 ANDA ANDA200981 Preferred Pharmaceuticals, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6787_782ba4c4-ae3f-4f85-b62b-7422ed3b896a 68788-6787 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20161102 ANDA ANDA090617 Preferred Pharmaceuticals, Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6788_f21adebc-028b-488a-93e1-1b4f907842b7 68788-6788 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20161102 ANDA ANDA090467 Preferred Pharmaceuticals Inc. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-6789_dadf3d8e-1639-47f5-ad25-55301ab0759b 68788-6789 HUMAN PRESCRIPTION DRUG Phenazopyridine HCl 200mg Phenazopyridine Hydrochloride TABLET ORAL 20161102 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 68788-6790_5feca838-2c28-4e70-902d-b99acb811e2b 68788-6790 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20161102 ANDA ANDA204597 Preferred Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6791_17c76c83-90f5-4762-87c3-c11a8857f8e4 68788-6791 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20161102 ANDA ANDA071250 Preferred Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 68788-6792_f9e6ae07-e58c-4f80-ade2-a198e4da8116 68788-6792 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20161102 ANDA ANDA062512 Preferred Pharmaceuticals, Inc. NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 68788-6793_f1d989cc-5c69-4e4d-bf36-6b6ee3b6856f 68788-6793 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20161102 ANDA ANDA203145 Preferred Pharmaceuticals, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-6794_20c9f87a-741f-493f-91b3-69cb76cc1d73 68788-6794 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20161103 ANDA ANDA204597 Preferred Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6796_0333a61f-d5bb-43be-9024-4c5a5e46e67a 68788-6796 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20161103 ANDA ANDA201966 Preferred Pharmaceuticals Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-6797_1dcd1e79-5c7a-4dcc-b164-9aa9a2738421 68788-6797 HUMAN PRESCRIPTION DRUG Ciclopirox Ciclopirox SOLUTION TOPICAL 20161103 ANDA ANDA077623 Preferred Pharmaceuticals, Inc. CICLOPIROX 80 mg/mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 68788-6798_5aee4caa-b607-448c-ad99-6f781131fb33 68788-6798 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20161103 ANDA ANDA090843 Preferred Pharmaceuticals, Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-6799_a0e79d63-ff5e-437a-8731-6535479273ee 68788-6799 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161028 ANDA ANDA078866 Preferred Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68788-6800_830808c8-d160-445a-87cb-85f0300449ce 68788-6800 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161031 ANDA ANDA077415 Preferred Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68788-6801_8140510e-1df7-4be5-9ca9-4cdc7264ae25 68788-6801 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20161103 ANDA ANDA091220 Preferred Pharmaceuticals Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68788-6802_0cd3dc11-f389-4c02-b819-e8b93c8339cd 68788-6802 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20161107 ANDA ANDA201407 Preferred Pharmaceuticals Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-6803_83996d79-c436-4325-bb4f-1dbfb3d43051 68788-6803 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20161107 ANDA ANDA203245 Preferred Pharmaceutical Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-6804_bca96e2f-a6f5-4034-86e9-c937d740c002 68788-6804 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20161107 ANDA ANDA091604 Preferred Pharmaceuticals Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-6805_83996d79-c436-4325-bb4f-1dbfb3d43051 68788-6805 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20161107 ANDA ANDA203245 Preferred Pharmaceutical Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-6806_4cad47be-8e9b-4e58-8056-e1d10c993d7e 68788-6806 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20161107 ANDA ANDA090174 Preferred Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6807_0956de91-d1b6-4e41-947c-5de1bad31d85 68788-6807 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20161107 NDA AUTHORIZED GENERIC NDA019594 Preferred Pharmaceuticals Inc. URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] N 20181231 68788-6808_ed97008b-e9f9-4dd2-a001-7a8a5a4b1771 68788-6808 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20161107 ANDA ANDA075932 Preferred Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68788-6809_e4bdab1c-386d-417f-aa24-5154ebf835ca 68788-6809 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20161107 ANDA ANDA206556 Preferred Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68788-6810_8788e172-4b41-4141-aea9-10a13b533f81 68788-6810 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20161107 ANDA ANDA077289 Preferred Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6811_0628ee4d-590d-4477-a509-09d524c837d9 68788-6811 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20161107 ANDA ANDA202554 Preferred Pharmaceuticals Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-6812_511ad655-14a1-4c4e-a632-9fe04f0fc10d 68788-6812 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20161206 ANDA ANDA091629 Preferred Pharmaceuticals Inc. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-6813_36066abe-0d79-467b-8835-594b032b9165 68788-6813 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20161108 ANDA ANDA203145 Preferred Pharmaceuticals, Inc. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-6814_1893a492-1ff9-43dc-b444-23ebbfa66367 68788-6814 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20161108 ANDA ANDA203311 Preferred Pharmaceuticals, Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-6815_535f130c-3b78-4650-9241-a0f65d22651b 68788-6815 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20161108 ANDA ANDA079170 Preferred Pharmaceuticals Incl ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6816_ae8ea71f-3a60-43d1-8ea1-a4888e35277f 68788-6816 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20161108 ANDA ANDA200839 Preferred Pharamaceuticals, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 68788-6817_96c59c14-9fab-438b-8e29-0a385b636d24 68788-6817 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20161115 ANDA ANDA078332 Preferred Pharmaceuticals, Inc CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68788-6818_78b1623e-d8ab-4cc2-852a-113a9599af3a 68788-6818 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20161117 ANDA ANDA091220 Preferred Pharmaceuticals Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68788-6819_96c59c14-9fab-438b-8e29-0a385b636d24 68788-6819 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20161115 ANDA ANDA078332 Preferred Pharmaceuticals, Inc CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68788-6820_6b7faac2-9efb-4ba8-8f08-e7a6b0851827 68788-6820 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Preferred Pharmaceuticals, Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-6821_d69a794a-873e-41ec-8b5f-3c6a7e639867 68788-6821 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20161116 ANDA ANDA091240 Preferred Pharmaceuticals Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6822_1b790fa4-6dd0-46c1-bbc9-2a929529d045 68788-6822 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20161116 ANDA ANDA077783 Preferred Pharmaceuticals, Inc LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68788-6823_deba9de5-92a1-48ac-b74d-3b99cc87b811 68788-6823 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20161117 ANDA ANDA079170 Preferred Pharmaceuticals, Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6824_66aca9a4-35a4-4534-a7da-d177eb7b9e0e 68788-6824 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20161116 ANDA ANDA090278 Preferred Pharmaceuticals, Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-6825_a04baea6-e10f-469a-b091-21955f7bff96 68788-6825 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20161116 ANDA ANDA202446 Preferred Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-6826_6b7749a7-f6c9-4779-b2e8-d29403a39f57 68788-6826 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20161116 ANDA ANDA090617 Preferred Pharmaceuticals, Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6827_5363e037-70dc-4307-8d22-2b46aebd1d99 68788-6827 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20170123 ANDA ANDA075677 Preferred Pharmaceuticals Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 68788-6828_90115c8f-550e-4c2b-b021-c45faa811950 68788-6828 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20161115 ANDA ANDA077987 Preferred Pharmaceuticals Inc., USA PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6829_847c7491-39d3-4ce9-9836-2534a576275f 68788-6829 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20161207 ANDA ANDA065373 Preferred Pharmaceuticals Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 68788-6830_07ef2d48-0381-4491-844f-9f51f31724f4 68788-6830 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161121 ANDA ANDA090700 Preferred Pharmaceuticals Inc. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-6831_2fc09fb6-00a3-4ac3-8f5c-25792338c7ae 68788-6831 HUMAN PRESCRIPTION DRUG Diclofenac sodium Diclofenac GEL TOPICAL 20161121 ANDA ANDA208077 Preferred Pharmaceuticals Inc. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6832_86af23a0-6930-451d-9815-1a64edb9c8e8 68788-6832 HUMAN PRESCRIPTION DRUG Junel Fe 1/20 norethindrone acetate and ethinyl estradiol, and ferrous fumarate KIT 20161121 ANDA ANDA076081 Preferred Pharmaceuticals Inc. N 20191231 68788-6833_9ca5dbe6-bdcc-4a1a-b611-0d60d5b61b01 68788-6833 HUMAN PRESCRIPTION DRUG Mefloquine Hydrochloride Mefloquine Hydrochloride TABLET ORAL 20161121 ANDA ANDA076392 Preferred Pharmaceuticals Inc. MEFLOQUINE HYDROCHLORIDE 250 mg/1 Antimalarial [EPC] N 20181231 68788-6834_a1a4e132-1cc4-42d0-bee3-7f5bf31a8c8e 68788-6834 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20161122 ANDA ANDA090174 Preferred Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6835_f0f4189d-9de7-49a0-908a-5e60636025d4 68788-6835 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20161121 ANDA ANDA077206 Preferred Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6836_f66a18f1-3c1a-4e6e-9eae-344d1f5b0fd0 68788-6836 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20161205 ANDA ANDA091624 Preferred Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6837_da79f292-3f9d-492d-b7b5-2b9af1ba5c5a 68788-6837 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20161205 ANDA ANDA202389 Preferred Pharmaceuticals Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6838_7a62fb93-e10a-4f9b-a2ac-d361ab002713 68788-6838 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20161205 ANDA ANDA078154 Preferred Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-6839_83409b37-916f-4522-a8e0-88fcf9c1932e 68788-6839 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20161205 ANDA ANDA202765 Preferred Pharmaceuticals Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68788-6840_8c543dd2-a773-483e-9a46-03bb6f859d27 68788-6840 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20161206 ANDA ANDA065429 Preferred Pharmaceuticals Inc. CEFDINIR MONOHYDRATE 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-6841_8931f950-8618-4e26-9ffb-86bd6eb3dbc2 68788-6841 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin Sulfate, Polymyxin B Sulfate, and Dexamethasone OINTMENT OPHTHALMIC 20161129 ANDA ANDA064063 Preferred Pharmaceuticals Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/g; [USP'U]/g; mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-6842_720d2e32-a462-4837-ac1a-09b8b59125d6 68788-6842 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20161212 ANDA ANDA078250 Preferred Pharmaceuticals Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6843_8f024ad3-dac9-445d-aa4c-328f32ded985 68788-6843 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20161206 ANDA ANDA205245 Preferred Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68788-6844_b671bb80-770a-48af-8286-ed1b6ae4ce75 68788-6844 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20161206 ANDA ANDA202556 Preferred Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-6845_d0aa8737-c207-4db2-8501-6ab0898aff4b 68788-6845 HUMAN PRESCRIPTION DRUG Levalbuterol tartrate HFA inhalation levalbuterol tartrate AEROSOL, METERED ORAL 20161206 NDA AUTHORIZED GENERIC NDA021730 Preferred Pharmaceuticals Inc. LEVALBUTEROL TARTRATE 45 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68788-6846_502102f1-d76b-42c1-80fa-4b529f4035f4 68788-6846 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20161207 ANDA ANDA200044 Preferred Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 68788-6847_64d47775-d485-41c7-9aab-b9ad169dc772 68788-6847 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20161207 ANDA ANDA077739 Preferred Pharmaceuticals Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6848_1efbebbf-93d8-4a55-902d-5815eabbc5bb 68788-6848 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20161205 ANDA ANDA202039 Preferred Pharmaceuticals Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 68788-6850_fceee8f7-0c9c-4f44-bef3-e359edfb21cb 68788-6850 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20161212 ANDA ANDA078989 Preferred Pharmaceuticals Inc. ZALEPLON 10 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] N 20181231 68788-6851_f169d6cb-dfd4-4247-bb81-cbd63b1734e7 68788-6851 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20161212 ANDA ANDA071135 Preferred Pharmaceuticals Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-6852_b964857b-2d30-4c78-9b09-6f56922aa6d0 68788-6852 HUMAN PRESCRIPTION DRUG Chlorthalidone Chlorthalidone TABLET ORAL 20161212 ANDA ANDA089286 Preferred Pharmaceuticals Inc. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 68788-6853_71f9694c-02a8-441a-b6db-879d0c8c0599 68788-6853 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20161213 ANDA ANDA074550 Preferred Pharmaceuticals Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68788-6854_71f9694c-02a8-441a-b6db-879d0c8c0599 68788-6854 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20161213 ANDA ANDA074550 Preferred Pharmaceuticals Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68788-6855_3ed98f5e-99a1-4380-858c-29a9aa79131f 68788-6855 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20161213 ANDA ANDA078494 Preferred Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6856_06acc46b-5f8a-41da-8302-03eaf131bcbe 68788-6856 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161213 ANDA ANDA077410 Preferred Pharmaceuticals Inc. NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-6857_68ebe7fe-b504-4fb6-b201-80ef0d79fc32 68788-6857 HUMAN OTC DRUG Muscle Rub Menthol, Methyl salicylate CREAM TOPICAL 20161222 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals Inc. MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 10; 15 g/100g; g/100g E 20171231 68788-6858_9e7770f4-2eab-4475-a47a-75e0e29a66be 68788-6858 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20170123 ANDA ANDA200839 Preferred Pharmaceuticals Inc. LEVOFLOXACIN 500 mg/1 N 20181231 68788-6859_4730e32a-16d6-4947-98a8-9678e03105a6 68788-6859 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20161222 ANDA ANDA078916 Preferred Pharmaceuticals Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68788-6862_6c27e9cb-fd88-4dd6-9262-f92d763cea5a 68788-6862 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20161227 ANDA ANDA091624 Preferred Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6863_a818d101-f6a0-4f62-a2a8-e3eb0fe89415 68788-6863 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20161227 ANDA ANDA075155 Preferred Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68788-6864_6651182b-3a54-41ff-9ac3-614d19e28acf 68788-6864 HUMAN PRESCRIPTION DRUG RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20170104 ANDA ANDA078964 Preferred Pharmaceuticals, Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68788-6865_2c175630-8b60-453a-a8ae-14fc892d8f92 68788-6865 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20170110 ANDA ANDA200739 Preferred Pharmaceuticals Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-6866_f7da69b7-0c24-48f8-ae5f-896c4ea58472 68788-6866 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20170110 ANDA ANDA205085 Preferred Pharmaceuticals Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-6868_2a12e342-8503-45ff-a023-e2c5722e9727 68788-6868 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, EXTENDED RELEASE ORAL 20170111 ANDA ANDA202383 Preferred Pharmaceuticals Inc. LAMOTRIGINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68788-6869_09743377-4da2-4b65-abdb-f45ebb40cb65 68788-6869 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20170111 ANDA ANDA088042 Preferred Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-6870_7d558598-6905-46da-8f34-668456c68411 68788-6870 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20170111 ANDA ANDA077584 Preferred Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6872_bd5c1d7b-1c97-4400-9d5b-4138fae8fc16 68788-6872 HUMAN OTC DRUG Tussin Multi Symptom Cold CF Adult Dextromethorphan HBr, Guaifenesin, Phenylephrine LIQUID ORAL 20170119 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 68788-6873_2e5bb25f-6a1f-4ff7-a720-3ba6bb4add17 68788-6873 HUMAN PRESCRIPTION DRUG Budesonide BUDESONIDE INHALANT RESPIRATORY (INHALATION) 20170120 ANDA ANDA078202 Preferred Pharmaceuticals Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-6874_c9ed2b81-d847-4e22-bf38-c4adc9095079 68788-6874 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20170119 NDA NDA016620 Preferred Pharmaceuticals Inc. NITROFURANTOIN 50 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 68788-6875_74b90430-8ce1-470c-939c-685ca9dfd74f 68788-6875 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20170123 ANDA ANDA203687 Preferred Pharmaceuticals Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68788-6876_cfa6da91-d55b-4828-a550-6625b5bafda5 68788-6876 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20170123 ANDA ANDA078296 Preferred Pharmaceuticals Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6878_6193ea49-5b41-4743-9969-138dc5d7aec9 68788-6878 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20170123 ANDA ANDA078888 Preferred Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 68788-6879_9d9f2332-56ab-4358-8357-27ad995ad58a 68788-6879 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET SUBLINGUAL 20170123 ANDA ANDA208191 Preferred Pharmaceuticals Inc. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68788-6880_5ee9346e-5307-43ea-8aae-8804abe2ca1b 68788-6880 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20170123 ANDA ANDA079106 Preferred Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE 6.25; 5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6881_aa8fc2ea-3942-453b-bc19-1e4b14ba6926 68788-6881 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20170120 ANDA ANDA091672 Preferred Pharmaceuticals Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-6882_fe3a18ca-1f3a-40d2-bc4b-42e78941c14b 68788-6882 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20170119 ANDA ANDA203311 Preferred Pharmaceuticals Inc. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-6884_6ed41bf6-6eb9-4024-a46b-e99c929a6649 68788-6884 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20170130 ANDA ANDA065243 Preferred Pharmaceuticals Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68788-6885_baa6018f-34d4-4654-a0ba-70521fcb72cd 68788-6885 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20170130 ANDA ANDA074388 Preferred Pharmaceuticals Inc. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68788-6886_aeaa9ba4-e2d7-4053-b182-b7b0ea56d62e 68788-6886 HUMAN OTC DRUG Childrens Silapap Acetaminophen LIQUID ORAL 20170201 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 68788-6887_c5d1c15e-79db-4fb1-9797-e4969600141f 68788-6887 HUMAN PRESCRIPTION DRUG clarithromycin clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170201 ANDA ANDA065145 Preferred Pharmaceuticals Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-6888_57d2c420-7327-40af-aa3c-df783003f336 68788-6888 HUMAN PRESCRIPTION DRUG Pioglitazone Hydrochloride pioglitazone hydrochloride TABLET ORAL 20170201 ANDA ANDA200044 Preferred Pharmaceuticals Inc. PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 68788-6889_01a3c9f6-41aa-47a7-8c56-5462c6b54416 68788-6889 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20170206 ANDA ANDA076118 Preferred Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-6890_8f1e2930-5594-4c7b-b311-13c358c8e24c 68788-6890 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20170213 ANDA ANDA090705 Preferred Pharmaceuticals Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-6891_04797177-8e7b-4216-8a48-5fc02af54064 68788-6891 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20170206 ANDA ANDA090705 Preferred Pharmaceuticals Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-6892_4a18b877-c5e7-4e3a-b0db-5b36ea1ba097 68788-6892 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20170213 ANDA ANDA203027 Preferred Pharmaceuticals Inc. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 68788-6893_76ecf12b-264d-46aa-bc7e-e75c99ab134c 68788-6893 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170210 ANDA ANDA090492 Preferred PHarmaceuticals Inc. DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 68788-6894_ace9eae8-5336-4c40-b8ce-105e2238a49a 68788-6894 HUMAN PRESCRIPTION DRUG Quinapril Quinapril Hydrochloride TABLET, FILM COATED ORAL 20170213 ANDA ANDA202725 Preferred Pharmaceuticals Inc. QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-6895_9595d16c-0d40-4bfc-980e-f0d051a12903 68788-6895 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170213 ANDA ANDA203253 Preferred Pharmaceuticals Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68788-6896_c153155b-69dc-41b7-91d2-0949ec496174 68788-6896 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20170213 ANDA ANDA077135 Preferred Pharmaceuticals Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68788-6897_0c2e2e6a-1887-4c86-8591-be1fddd4425d 68788-6897 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20170214 ANDA ANDA075693 Preferred Pharmaceuticals Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68788-6898_dea3c9f7-b563-4628-9df5-3af3cc3db47b 68788-6898 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20170214 ANDA ANDA076180 Preferred Pharmaceuticals Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-6899_f5bfd079-7eff-4d8d-b455-d625d8213c98 68788-6899 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170214 ANDA ANDA202446 Preferred Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-6900_9595d16c-0d40-4bfc-980e-f0d051a12903 68788-6900 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170213 ANDA ANDA203253 Preferred Pharmaceuticals Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68788-6901_b3e19db6-7b05-4720-9771-1ad3990cb291 68788-6901 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20170228 ANDA ANDA076004 Preferred Pharmaceuticals Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6903_4374ab41-766a-476f-8584-a229169ba2db 68788-6903 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20170222 ANDA ANDA072235 Preferred Pharmaceuticals Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68788-6904_25483b41-d84a-4eb2-9e86-56d0c58649d9 68788-6904 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20170228 ANDA ANDA203482 Preferred Pharmaceuticals Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-6905_4be038ce-82d4-442a-81e6-30604992983a 68788-6905 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20170223 ANDA ANDA077946 Preferred Pharmaceuticals Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 68788-6907_88f33bbe-4031-4f47-af4f-3125d5845dea 68788-6907 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20170223 ANDA ANDA077739 Preferred Pharmaceuticals Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6908_3acee546-227d-4f1a-93bb-1ce0c218203f 68788-6908 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20170222 ANDA ANDA075227 Preferred Pharmaceuticals Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6909_832ebcc5-a746-44d0-b619-6fd19d820561 68788-6909 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170222 ANDA ANDA091625 Preferred Pharmaceuticals Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6915_4188b01d-c7e6-45de-87fe-b9bfeedefa64 68788-6915 HUMAN PRESCRIPTION DRUG glyburide and metformin hydrochloride glyburide and metformin hydrochloride TABLET ORAL 20170301 ANDA ANDA206748 Preferred Pharmaceuticals Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-6916_7fe0d769-8d60-48f6-8340-2cd3d90584de 68788-6916 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20170301 ANDA ANDA076343 Preferred Pharmaceuticals Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-6917_08bb7d5b-a6e7-41bd-bdd4-195e1db0fc66 68788-6917 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20170228 ANDA ANDA086242 Preferred Pharmaceuticals Inc HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 68788-6918_6a09c18d-1ba3-4ba5-a6b1-124412870445 68788-6918 HUMAN OTC DRUG Q Tapp Cold and Cough Brompheniramine maleate and Dextromethorphan HBr and Pseudoephedrine HCl LIQUID ORAL 20170221 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 5; 15 mg/5mL; mg/5mL; mg/5mL N 20181231 68788-6919_a66bf564-ce9f-42f6-b6e0-61b0e58474bc 68788-6919 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20170306 ANDA ANDA077397 Preferred Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6920_f543ab51-9880-48ea-81d0-c24b636d7f01 68788-6920 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20170306 ANDA ANDA076164 Preferred Pharmaceuticals Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-6921_a0589722-b068-4e94-b89c-7d139a203170 68788-6921 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20170306 ANDA ANDA201519 Preferred Pharmaceuticals Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 68788-6922_a070db24-adec-445f-bc55-24c7409ab90d 68788-6922 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE ORAL 20170306 ANDA ANDA203636 Preferred Pharmaceuticals Inc. ESOMEPRAZOLE MAGNESIUM 40 1/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-6923_7afbe4a9-7dc9-4961-bc2d-e9a4db9e7572 68788-6923 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20170313 ANDA ANDA077397 Preferred Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6926_877d8392-e94e-4ad9-9d54-b6ce061fb60c 68788-6926 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20170405 NDA NDA021433 Preferred Pharmaceuticals Inc. FLUTICASONE PROPIONATE 44 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-6928_4efb9b61-24a7-4408-af27-fff7cee54624 68788-6928 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070218 Preferred Pharmaceuticals Inc. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6929_b55d9e6b-693e-49ee-b50c-e552b82e3833 68788-6929 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, FILM COATED ORAL 20170322 ANDA ANDA090404 Preferred Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68788-6930_852a13a0-b505-4d1b-847d-8ac30919ee84 68788-6930 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20170322 ANDA ANDA203458 Preferred Pharmaceutiicals Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68788-6931_e6181fd2-ee96-4573-917f-7047b522172f 68788-6931 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20170327 ANDA ANDA206556 Preferred Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68788-6932_98f242e6-2108-44ed-b4a6-b20d5cd52a52 68788-6932 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE EXTENDED RELEASE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20170327 ANDA ANDA090295 Preferred Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-6933_d57f115a-1e33-4957-867e-8193f1e23ab9 68788-6933 HUMAN OTC DRUG good sense tussin dm Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 20170327 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 68788-6934_5b358e89-7570-49db-a2b3-14a60480d158 68788-6934 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20170327 ANDA ANDA078314 Preferred Pharmaceuticals Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6935_a2bfc54a-9622-4e7c-a271-db9b6168e79f 68788-6935 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20170328 ANDA ANDA077073 Preferred Pharmaceuticals Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-6936_6eb153ef-5a8c-4977-8ecc-04e91b545b55 68788-6936 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20170327 ANDA ANDA065489 Preferred Pharmaceuticals Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-6937_e2f2c835-2d87-468f-af0e-733308cf6c56 68788-6937 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20170328 ANDA ANDA084285 Preferred Pharmaceuticals Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68788-6938_59974ec5-1f60-4928-9f13-ffde3346e04b 68788-6938 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20170404 ANDA ANDA202801 Preferred Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 68788-6939_85ce51e7-18c5-4ef2-8084-b1629dc32263 68788-6939 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20170329 ANDA ANDA200243 Preferred Pharmaceuticals Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68788-6940_84c24647-f182-4b4d-b5a0-e55721db8922 68788-6940 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20170405 ANDA ANDA091624 Preferred Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6941_99a365c8-baec-4183-b6ef-a1dd8ebf45df 68788-6941 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20170405 ANDA ANDA204197 Preferred Pharmaceuticals Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6942_771ab1ea-cd81-4c66-b674-da23720f350a 68788-6942 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20170405 ANDA ANDA071136 Preferred Pharmaceuticals Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-6943_7ce422d9-0ee2-419d-bdac-906f45598147 68788-6943 HUMAN PRESCRIPTION DRUG Alprazolam Extended Release Alprazolam TABLET, EXTENDED RELEASE ORAL 20170414 ANDA ANDA078056 Preferred Pharmaceuticals Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-6944_1283ac78-61fe-444b-a2f8-42ada5db34d2 68788-6944 HUMAN OTC DRUG Meclizine HCl 25 mg Meclizine Hydrochloride TABLET, CHEWABLE ORAL 20170417 OTC MONOGRAPH FINAL part336 Preferred Pharmaceuticals Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 68788-6946_3dedce33-76bf-47ee-8fe7-5eb924cf83a9 68788-6946 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20170417 ANDA ANDA090984 Preferred Pharmaceuticals Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68788-6947_5a88ad3c-9fe2-46ba-b532-1f6494faa2b2 68788-6947 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate OINTMENT TOPICAL 20170417 NDA NDA019141 Preferred Pharmaceuticals Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-6948_cad102d7-0197-4cff-bb80-9f0b5bcb599b 68788-6948 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20170417 ANDA ANDA077293 Preferred Pharmaceuticals Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68788-6950_80f4d014-e169-4e8d-8dbd-f3d81e612439 68788-6950 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20170424 ANDA ANDA040796 Preferred Pharmaceuticals Inc. FOLIC ACID 1 mg/1 N 20181231 68788-6951_2dbd56d5-2bb5-4697-b7cb-e4c154321997 68788-6951 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET ORAL 20170424 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 68788-6952_57766ab5-bc5f-45bf-894c-51aa765a0f03 68788-6952 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20170501 ANDA ANDA074394 Preferred Pharmaceuticals Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6953_a03ffcd7-abc3-404e-b7ea-826d87a06f0d 68788-6953 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20170501 ANDA ANDA202929 Preferred Pharmaceuticals Inc. ESZOPICLONE 1 mg/1 CIV N 20181231 68788-6955_f01f2ed5-b0d8-420c-b2f0-988c86951464 68788-6955 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20170502 ANDA ANDA206434 Preferred Pharmaceuticals Inc. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6956_61d5c154-1927-46b1-aba3-625831d17ac1 68788-6956 HUMAN OTC DRUG Meclizine HCL 12.5 mg Meclizine HCL 12.5 mg TABLET ORAL 20170502 OTC MONOGRAPH FINAL part336 Preferred Pharmaceuticals Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 68788-6957_4d5a8b50-dd2f-4329-9e28-93608e8fe8da 68788-6957 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20170502 ANDA ANDA076118 Preferred Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-6958_77816476-61e8-4d57-bccd-ef83de9d8812 68788-6958 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20170509 ANDA ANDA077575 Preferred Pharmaceuticals Inc. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6959_37bc765e-394a-4c09-bf53-a4ce5fe9d0c1 68788-6959 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin Phosphate SOLUTION TOPICAL 20170509 ANDA ANDA064050 Preferred Pharmaceuticals Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68788-6960_3e0a14f1-961b-4722-bfea-aafcc5d7706c 68788-6960 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20170509 ANDA ANDA203458 Preferred Pharmaceuticals Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68788-6963_20088458-0469-4bd7-b41d-8e7313f03db1 68788-6963 HUMAN OTC DRUG Good Sense Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20170518 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 68788-6964_796e7c5b-857d-4aca-8fc8-bdb81f9f5c4a 68788-6964 HUMAN OTC DRUG Ferrous Sulfate Ferrous Sulfate TABLET, FILM COATED ORAL 20170518 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals Inc. FERROUS SULFATE 325 mg/1 N 20181231 68788-6966_bdd92504-df75-476a-a7fe-f4f49faecf42 68788-6966 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20170518 ANDA ANDA090843 Preferred Pharmaceuticals Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-6967_8d41ba6d-6a5c-4bc2-b893-78d11c33c663 68788-6967 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170518 ANDA ANDA065154 Preferred Pharmaceuticals Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-6968_9f1afadf-c58e-48d9-a013-e78c792f078d 68788-6968 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20170518 ANDA ANDA204309 Preferred Pharmaceuticals Inc. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 68788-6969_aa63d508-a5c4-43e8-940c-7a66a4000f29 68788-6969 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20170518 ANDA ANDA076900 Preferred Pharmaceuticals Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-6970_903fb100-1424-4875-9581-79e548fe4f0d 68788-6970 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, COATED ORAL 20161031 ANDA ANDA201619 Preferred Pharmaceuticals Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-6971_729d3452-6cd3-43d6-a853-e5ea1c4ad617 68788-6971 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20170522 ANDA ANDA203126 Preferred Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-6972_19125222-428f-4194-9eea-8477d8fc35b5 68788-6972 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20170607 ANDA ANDA076194 Preferred Pharmaceuticals Inc. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-6973_e6021495-eadf-46dc-8ff0-cafcbcbca7d6 68788-6973 HUMAN OTC DRUG Advanced Eye Relief/ Redness Maximum Relief Naphazoline Hydrochloride and Hypromellose SOLUTION/ DROPS OPHTHALMIC 20100902 OTC MONOGRAPH FINAL part349 Preferred Pharmaceuticals Inc. HYPROMELLOSE, UNSPECIFIED; NAPHAZOLINE HYDROCHLORIDE 5; .3 mg/mL; mg/mL N 20181231 68788-6974_4bf5a9c3-1426-44ef-928d-70e70f0918d7 68788-6974 HUMAN OTC DRUG dimaphen dm Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20170606 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals Inc. BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 68788-6975_47eccf62-0da5-4ace-b8d1-0d1ae4305be4 68788-6975 HUMAN PRESCRIPTION DRUG amantadine hydrochloride amantadine hydrochloride CAPSULE ORAL 20160804 ANDA ANDA208278 Preferred Pharmaceuticals Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 68788-6976_d36827bc-0e0f-4328-a6ee-4927829426f7 68788-6976 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20170606 ANDA ANDA090121 Preferred Pharmacetucals Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68788-6977_56397c27-02e3-474a-8175-2cb2e24075d0 68788-6977 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride TABLET, FILM COATED ORAL 20170606 ANDA ANDA203854 Preferred Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6978_a7d40aa1-6590-4f96-833a-02f5f902a9a2 68788-6978 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20170606 ANDA ANDA090939 Preferred Pharmaceuticals Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6979_0ce36979-80ed-4004-ae66-fc79dd2b68a7 68788-6979 HUMAN PRESCRIPTION DRUG HYDROQUINONE 4% Hydroquinone CREAM TOPICAL 20170606 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 68788-6981_a54bb224-3295-4ed8-926a-2d81ca2eabb9 68788-6981 HUMAN PRESCRIPTION DRUG Triamcinolone acetonide Triamcinolone acetonide CREAM TOPICAL 20170613 ANDA ANDA088042 Preferred Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-6982_add856cc-a8ac-4019-a04a-3a7d9ad63684 68788-6982 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20170705 ANDA ANDA091184 Preferred Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-6983_ae5c0754-71eb-42ac-b3ab-e16fe61949b5 68788-6983 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20170705 ANDA ANDA091276 Preferred Pharmaceuticals Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6984_c4cc1070-21e0-434b-b74c-9e49bfa824fe 68788-6984 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20170705 ANDA ANDA202557 Preferred Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 68788-6985_1ef626e0-d347-4453-9c71-d90748a66922 68788-6985 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride TABLET, FILM COATED ORAL 20170705 ANDA ANDA203854 Preferred Pharmaceuticals Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-6986_6beccd63-d4f7-4ffd-89ef-bc63707d6c78 68788-6986 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20170705 ANDA ANDA071620 Preferred Pharmaceuticals Inc. TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-6987_f52d12ef-b3c8-4d85-9db7-aed9cb496b46 68788-6987 HUMAN OTC DRUG Major LubriFresh PM Mineral oil and White petrolatum OINTMENT OPHTHALMIC 20170705 OTC MONOGRAPH FINAL part349 Preferred Pharmaceuticals Inc. MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g N 20181231 68788-6989_b70840c0-ad3a-42bd-bf92-042a24f4d06e 68788-6989 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20170713 ANDA ANDA077147 Preferred Pharmaceuticals Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-6990_3181171e-da7b-4d27-8e4e-874d72734495 68788-6990 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20170713 ANDA ANDA202894 Preferred Pharmaceuticals Inc. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-6994_8f36fc32-fda6-4c8e-ad28-3e71f2041996 68788-6994 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20170726 ANDA ANDA076143 Preferred Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68788-6995_fa0395a7-4353-4d64-9de8-d15857a7031c 68788-6995 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20171027 ANDA ANDA091672 Preferred Pharmaceuticals Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-6997_8497bd3f-832b-4648-bc5d-d2533e59989f 68788-6997 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20170724 ANDA ANDA090867 Preferred Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68788-6998_70c2b823-bb42-46fa-b8b2-675fe6abb207 68788-6998 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20170724 ANDA ANDA091416 Preferred Pharmaceuticals Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-6999_84be5a4f-ccd2-4214-b28e-c279b3321c48 68788-6999 HUMAN OTC DRUG Polysporin First Aid Antibiotic Bacitracin and polymyxin B sulfate OINTMENT TOPICAL 20130709 20181101 OTC MONOGRAPH FINAL part333B Preferred Pharmaceuticals Inc. BACITRACIN; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 68788-7000_ba86b7dc-6e1c-4e99-a755-3e49833e9ca7 68788-7000 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET, FILM COATED ORAL 20060510 ANDA ANDA076635 Preferred Pharmaceuticals Inc. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 68788-7001_69bc3ddc-dbe6-4116-8d81-99855f2d3bd4 68788-7001 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170807 ANDA ANDA202825 Preferred Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-7002_5c625845-552d-44dc-8373-1e1eea607b35 68788-7002 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20170807 ANDA ANDA078296 Preferred Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-7003_ec9afe48-9421-43c7-a501-565bd41ee0f4 68788-7003 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20170811 ANDA ANDA076407 Preferred Pharmaceuticals Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-7004_6ba61c81-e214-4cf8-9fe0-0a1b2af181fd 68788-7004 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20170811 ANDA ANDA071196 Preferred Pharmaceuticals Inc. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68788-7005_70b33418-121b-4441-8fc4-f25905a66870 68788-7005 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN TABLET, FILM COATED ORAL 20170811 ANDA ANDA203244 Preferred Pharmaceuticals Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-7006_f6623154-ae05-44c3-b7f8-e1fde35fa311 68788-7006 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20170816 ANDA ANDA201519 Preferred Pharmaceuticals Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 68788-7007_bc70bb9f-38c2-4a4a-9401-8ed11db413d9 68788-7007 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20170817 ANDA ANDA040911 Preferred Pharmaceuticals Inc. LIDOCAINE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 68788-7008_255cc966-a6ed-4fea-96e7-bb6a2064ef67 68788-7008 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20170817 ANDA ANDA091604 Preferred Pharmaceuticals Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-7010_2b1a4e21-5a41-456a-81a5-2814a9a11ab3 68788-7010 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Preferred Pharmaceuticals Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-7011_991b0066-ffdc-4ca5-8aa1-15674bcdedd1 68788-7011 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET ORAL 20170828 ANDA ANDA077836 Preferred Pharmaceuticals Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 68788-7012_ab561d21-7466-4d8b-8d06-291c1d4d82ff 68788-7012 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20180104 ANDA ANDA076164 Preferred Pharmaceuticals Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 68788-7013_0e453c48-846b-4343-91c8-deb62356b8c4 68788-7013 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170829 ANDA ANDA207068 Preferred Pharmaceuticals Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-7014_2a2e4a1f-796a-4ace-80ba-ce2c17f14157 68788-7014 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20170829 ANDA ANDA091133 Preferred Pharmaceuticals Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68788-7015_eed496d2-c7af-4f53-961a-65bf3e8dcd60 68788-7015 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium Sulfacetamide Sodium SOLUTION OPHTHALMIC 20171011 ANDA ANDA089560 Preferred Pharmaceuticals Inc. SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 68788-7016_ce07c1c5-5d85-4b73-a9c2-cd946f07c54f 68788-7016 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20171003 ANDA ANDA076343 Preferred Pharmaceuticals Inc. TOPIRAMATE 25 meq/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-7017_e676c4a0-9367-469f-bdab-fa6269562408 68788-7017 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20171011 ANDA ANDA202557 Preferred Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 68788-7018_c0882edb-e2ad-470e-b26d-3c83b657abf9 68788-7018 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20171011 ANDA ANDA203695 Preferred Pharmaceuticals Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 68788-7019_1c4c5aed-5ee4-4b85-954b-9e80551985c1 68788-7019 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20171011 ANDA ANDA203512 Preferred Pharmaceuticals Inc. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68788-7020_a03b5f98-a87b-4f74-b4fa-c744026ec5e3 68788-7020 HUMAN PRESCRIPTION DRUG Budesonide Budesonide SUSPENSION RESPIRATORY (INHALATION) 20171011 ANDA ANDA201966 Preferred Pharmaceuticals Inc. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-7021_2ec03dc2-1342-4c44-adbc-aa2dcf386590 68788-7021 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20171011 ANDA ANDA086727 Preferred Pharmaceuticals Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 68788-7023_cd591056-5773-426f-961b-dfebd7955637 68788-7023 HUMAN OTC DRUG dimaphen phenylephrine hcl, brompheniramine maleate LIQUID ORAL 20171017 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals Inc. PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 68788-7025_0e1a7861-e097-4b0c-bfe3-6d2d98a8bedb 68788-7025 HUMAN PRESCRIPTION DRUG QVAR beclomethasone dipropionate AEROSOL, METERED RESPIRATORY (INHALATION) 20171011 NDA NDA020911 Preferred Pharmaceuticals Inc. BECLOMETHASONE DIPROPIONATE 80 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-7026_08216bb6-d280-4916-a5ee-ba998483768f 68788-7026 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20171012 NDA AUTHORIZED GENERIC NDA021342 Preferrred Pharmaeuticals Inc. LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-7027_f8c18f01-df62-463d-b0bb-aa7c0d0468ae 68788-7027 HUMAN OTC DRUG Childrens Loratadine Loratadine SOLUTION ORAL 20171012 ANDA ANDA076805 Preferred Pharmaceuticals Inc. LORATADINE 5 mg/5mL N 20181231 68788-7028_6a64c666-0267-4b4a-a1e3-733844e77fe6 68788-7028 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride SOLUTION ORAL 20171012 ANDA ANDA040643 Preferred Pharmaceutical Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68788-7029_abe3a610-a25d-4b52-8537-c87e8ba3104a 68788-7029 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20171012 ANDA ANDA202929 Preferred Pharmaceuticals Inc. ESZOPICLONE 2 mg/1 CIV N 20181231 68788-7030_146b4d1b-f9b5-4f6a-b694-0bad1214e110 68788-7030 HUMAN PRESCRIPTION DRUG NP Thyroid 15 LEVOTHYROXINE, LIOTHYRONINE TABLET ORAL 20171012 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals Inc. LEVOTHYROXINE; LIOTHYRONINE 9.5; 2.25 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20191231 68788-7031_a7513e6c-c19a-408e-8706-1c9ee9a8306f 68788-7031 HUMAN PRESCRIPTION DRUG NP Thyroid 30 LEVOTHYROXINE, LIOTHYRONINE TABLET ORAL 20171012 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals Inc. LEVOTHYROXINE; LIOTHYRONINE 19; 4.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 68788-7032_4ffa135f-f073-4fd5-b6a8-5efe419b179d 68788-7032 HUMAN PRESCRIPTION DRUG NP Thyroid 60 LEVOTHYROXINE, LIOTHYRONINE TABLET ORAL 20171012 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals Inc. LEVOTHYROXINE; LIOTHYRONINE 38; 9 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 68788-7033_c07993d0-12c0-4fad-82f3-d951e351e90c 68788-7033 HUMAN PRESCRIPTION DRUG NP Thyroid 90 LEVOTHYROXINE, LIOTHYRONINE TABLET ORAL 20171012 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals Inc. LEVOTHYROXINE; LIOTHYRONINE 57; 13.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 68788-7034_a27d9680-e8c1-4824-b943-15d476fbeacc 68788-7034 HUMAN PRESCRIPTION DRUG NP Thyroid 120 LEVOTHYROXINE, LIOTHYRONINE TABLET ORAL 20171012 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals Inc. LEVOTHYROXINE; LIOTHYRONINE 76; 18 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 68788-7035_02d3e66c-8b27-47e9-86ce-65bc49c352df 68788-7035 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20171016 ANDA ANDA202825 Preferred Pharmaceuticals Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-7036_9f96a0fb-21e2-40af-a33c-cf0984fe2550 68788-7036 HUMAN PRESCRIPTION DRUG Tri-Lo-Sprintec Norgestimate and Ethinyl Estradiol KIT 20171017 ANDA ANDA076784 Preferred Pharmaceuticals Inc. N 20181231 68788-7037_6a7054e8-d16a-4239-91a5-4eb920142082 68788-7037 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20171101 ANDA ANDA202801 Preferred Pharmaceuticals Inc. LEVOFLOXACIN 750 mg/1 N 20181231 68788-7039_b133f80e-6c67-485e-a537-38f6ec4c4b9e 68788-7039 HUMAN PRESCRIPTION DRUG TRETINOIN tretinoin CREAM TOPICAL 20171027 ANDA ANDA075265 Preferred Pharmaceuticals Inc. TRETINOIN .5 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 68788-7040_1d4e6c69-1ae2-4eff-99fa-d2b0fdf12bb7 68788-7040 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate LOTION TOPICAL 20171027 ANDA ANDA065067 Preferred Pharmaceuticals Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68788-7041_13f70275-a8d7-4ec8-9bdc-fe35834632ea 68788-7041 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20171027 ANDA ANDA073085 Preferred Pharmaceuticals Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-7042_1279cb7c-d0b6-4429-b0d0-72c1cfdd69e0 68788-7042 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20171030 ANDA ANDA090705 Preferred Pharmaceuticals Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-7043_e1b87541-af38-4a3e-a35a-1235bf42e83a 68788-7043 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20171031 ANDA ANDA090858 Preferred Pharmaceuticals Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-7044_d81441df-60f5-46fb-8260-3fb27721924e 68788-7044 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20171031 ANDA ANDA090858 Preferred Pharmaceuticals Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-7045_44b7669f-d980-4898-9952-0f13175ac6ae 68788-7045 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20171031 ANDA ANDA078423 Preferred Pharmaceutical Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68788-7046_f575d0ed-d993-46d4-8493-2865d6e31981 68788-7046 HUMAN PRESCRIPTION DRUG RIZATRIPTAN Benzoate RIZATRIPTAN Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20171031 ANDA ANDA203478 Preferred Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68788-7047_bffa32d4-e529-42c2-a62c-bb99a3efe4b8 68788-7047 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE DENTAL 20171031 ANDA ANDA205592 Preferred Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-7048_7e75063c-6604-4109-8192-1745392eb5a5 68788-7048 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20171101 ANDA ANDA086415 Preferred Pharmaceuticals Inc. TRIAMCINOLONE ACETONIDE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-7049_d9f836d6-4442-4d31-a47a-14a744574c8c 68788-7049 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20171031 ANDA ANDA202764 Preferred Pharmaceuticals Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-7051_9952d3e2-25ef-408b-9d9a-a3cb95031854 68788-7051 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20171106 ANDA ANDA203512 Preferred Pharmaceuticals Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68788-7052_caa99901-467c-4e99-b7e9-fbabdf5d118c 68788-7052 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20171106 ANDA ANDA065470 Preferred Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68788-7053_e17992fb-c3e9-440e-b2ba-91f8a8b1ab04 68788-7053 HUMAN PRESCRIPTION DRUG FOLIC ACID folic acid TABLET ORAL 20171106 ANDA ANDA204418 Preferred Pharmaceuticals Inc. FOLIC ACID 1 mg/1 N 20181231 68788-7054_646c05cf-6a44-4281-bc1c-a77851b66fba 68788-7054 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20171106 ANDA ANDA040197 Preferred Pharmaceuticals Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68788-7055_9024419b-2916-4de2-b743-23b431c46047 68788-7055 HUMAN OTC DRUG Mineral Oil Mineral Oil OIL ORAL 20180104 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals Inc. MINERAL OIL 471.9528 g/472mL N 20191231 68788-7056_56680dfa-abe6-4587-b222-364315fd78f4 68788-7056 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20180105 ANDA ANDA075991 Preferred Pharmaceuticals Inc. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68788-7057_d08c0ade-3c5f-4c75-9fe8-97d4d83f85ec 68788-7057 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate Clindamycin Phosphate SOLUTION TOPICAL 20180104 ANDA ANDA206945 Preferred Pharmaceuticals Inc. CLINDAMYCIN PHOSPHATE 10 mg/mL Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 68788-7058_d884a058-3cdf-45de-a56b-54a5c7aa68d9 68788-7058 HUMAN OTC DRUG Eye Irrigating purified water SOLUTION OPHTHALMIC 20180104 OTC MONOGRAPH FINAL part349 Preferred Pharmaceuticals Inc. WATER 99.05 mL/100mL N 20191231 68788-7059_37a38dd5-da5c-435f-b86c-1912afe63a9c 68788-7059 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride CAPSULE ORAL 20180104 ANDA ANDA040319 Preferred Pharmaceuticals Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 68788-7060_3991e643-cae5-487a-863c-c02967216907 68788-7060 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20180104 ANDA ANDA077731 Preferred Pharmaceuticals Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 68788-7061_8850dba2-c8cd-4dbc-948f-040351c9ea4d 68788-7061 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20180104 ANDA ANDA202446 Preferred Pharmaceuticals Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 68788-7062_9d30b833-94fb-4dad-86fe-e73b62fc3461 68788-7062 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir POWDER, FOR SUSPENSION ORAL 20180104 ANDA ANDA065259 Preferred Pharmaceuticals, Inc. CEFDINIR 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 68788-7063_faa3032b-d9a1-45dd-88be-abb432223f13 68788-7063 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20180105 ANDA ANDA201519 Preferred Pharmaceuticals Inc. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20191231 68788-7064_b7918480-0a92-40bc-90cc-2401ffdb205a 68788-7064 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20180105 ANDA ANDA090984 {Preferred Pharmaeutials INC. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 68788-7066_e58b1004-6e10-4151-b93b-218bf1345bfc 68788-7066 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20180103 ANDA ANDA065211 Preferred Pharmaceuticals Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 68788-7067_9844c7c7-04d7-44ce-b0f9-312f28765a6c 68788-7067 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20180103 ANDA ANDA065117 Preferred Pharmaceuticals Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 68788-7068_465c43a1-e194-4aa1-8846-efad933edc95 68788-7068 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 20180103 ANDA ANDA074903 Preferred Pharmaceuticals Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68788-7069_e45c39a5-35fb-4445-a5e5-4e8dd661a8c8 68788-7069 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20180103 ANDA ANDA091184 Preferred Pharmaceuticals Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 68788-7070_3592b3b4-1e30-4528-9c9f-bc4fd0a1ccbf 68788-7070 HUMAN PRESCRIPTION DRUG OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE ORAL 20180102 ANDA ANDA208578 Preferred Pharmaceuticals Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 N 20191231 68788-7071_394f36d5-13d3-469d-8bbb-1eb076c3f3f4 68788-7071 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20180102 ANDA ANDA076900 Preferred Pharmaceuticals Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 68788-7072_9a13b256-ca82-4f7d-a8ea-a59c60703e92 68788-7072 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20180102 ANDA ANDA075227 Preferred Pharmaceuticals Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68788-7073_59b2c647-3521-474e-ac36-5687f67bea82 68788-7073 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20180102 ANDA ANDA207466 Preferred Pharmaceuticals Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20191231 68788-7074_c1326a51-141a-46a4-bd1e-57538ce22275 68788-7074 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20180102 ANDA ANDA078106 Preferred Pharmaceuticals Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 68788-7075_d3701428-011e-4318-9e67-c122fcc1d1d1 68788-7075 HUMAN OTC DRUG 12 Hour Original Nasal Decongestant Nasal Spray LIQUID NASAL 20180102 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals Inc. OXYMETAZOLINE HYDROCHLORIDE 50 mg/100mL N 20191231 68788-7076_8f115a0e-12eb-4d05-b408-f00174e20949 68788-7076 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20180103 ANDA ANDA201519 Preferred Pharmaceuticals Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20191231 68788-7077_4abdab69-194b-4607-84ad-dee264d49fd3 68788-7077 HUMAN OTC DRUG Aspirin NSAID Aspirin TABLET ORAL 20180124 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals Inc. ASPIRIN 325 mg/1 N 20191231 68788-7078_0e466ae5-a284-49be-b7a5-0f135e3ab9f4 68788-7078 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20180111 ANDA ANDA077824 Preferred Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 68788-7080_a175df89-865e-47ab-9277-0f098cc1a24a 68788-7080 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20180111 ANDA ANDA091625 Preferred Pharmaceuticals Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68788-7081_6a6af9ba-d579-4fc9-a3f2-fdb037ccac74 68788-7081 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20180111 NDA AUTHORIZED GENERIC NDA021342 Preferred Pharmaceuticals Inc. LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 68788-7082_283155ba-79bf-4573-b065-7094bae7aaea 68788-7082 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20180112 ANDA ANDA065212 Preferred Pharmaceuticals Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 68788-7083_d35bc05e-f0c4-4779-99af-91c7b919fb3e 68788-7083 HUMAN PRESCRIPTION DRUG SULFATRIM Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20180125 NDA NDA018615 Preferred Pharmaceuticals Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 68788-7084_06982019-25a2-4bea-9e20-6c42b37c803e 68788-7084 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20180125 ANDA ANDA091205 Preferred Pharmaceuticals Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20191231 68788-7085_aa287c98-42f1-40bb-bd84-99f5427b38b9 68788-7085 HUMAN OTC DRUG LORATADINE Loratadine TABLET ORAL 20180125 ANDA ANDA076471 Preferred Pharmaceuticals Inc. LORATADINE 10 mg/1 N 20191231 68788-7086_662c6f1a-ca1e-40ea-952d-122b680fdb89 68788-7086 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20180126 ANDA ANDA206434 Preferred Pharmaceuticals Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 68788-7087_233cee53-6df7-4999-ac15-f189a15d2ae1 68788-7087 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20180126 ANDA ANDA040749 Preferred Pharmaceuticals Inc BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 68788-7088_1fce862d-3753-4a33-b78c-80b8d21f1f64 68788-7088 HUMAN PRESCRIPTION DRUG Amantadine Hydrochloride Amantadine Hydrochloride SOLUTION ORAL 20180126 ANDA ANDA074170 Preferred Pharmaceuticals Inc. AMANTADINE HYDROCHLORIDE 50 mg/5mL Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20191231 68788-7089_e1bd3421-b618-4958-b849-3019a04378f0 68788-7089 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET, FILM COATED ORAL 20180129 ANDA ANDA204507 Preferred Pharmaceuticals Inc. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20191231 68788-7090_c5e52ddd-a909-487a-bb46-01ad35690665 68788-7090 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20180129 ANDA ANDA075927 Preferred Pharmaceuticals Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68788-7365_01dcb1af-37a4-4f6b-81bc-0eee91825f35 68788-7365 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20110321 ANDA ANDA076958 Preferred Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-7366_899d712e-ffbf-4a9b-946f-bdc0b066a715 68788-7366 HUMAN PRESCRIPTION DRUG Nystatin Nystatin CREAM TOPICAL 20160822 ANDA ANDA064022 Preferred Pharmaceuticals Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 68788-7368_5314172a-85cf-4386-b442-9de33d718f23 68788-7368 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20160822 ANDA ANDA074052 Preferred Pharmaceuticals Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-7369_61b4ad60-461b-41ff-a8de-1ec99a3106c3 68788-7369 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET ORAL 20160825 ANDA ANDA076497 Preferred Pharmaceuticals Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 68788-7370_a2a89726-639d-4a5b-8604-3f035c6d1f81 68788-7370 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20160822 ANDA ANDA065062 Preferred Pharmaceuticals Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68788-7371_01eef1ec-dc19-447b-9651-bbae7f45e452 68788-7371 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 20160822 ANDA ANDA062500 Preferred Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68788-7372_0e0166d9-5727-421b-88f6-d8299a43b447 68788-7372 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20170221 ANDA ANDA040362 Preferred Pharmaceuticals Inc. PREDNISONE 5 mg/1 N 20181231 68788-7373_f2c3707e-f631-4208-b335-1c4147931ea6 68788-7373 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20160822 ANDA ANDA201384 Preferred Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68788-7374_b681682e-12dd-40f1-ad75-b49ead996435 68788-7374 HUMAN OTC DRUG Antifungal miconazole nitrate CREAM TOPICAL 20160825 OTC MONOGRAPH FINAL part333C Preferred Pharmaceuticals Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 68788-7375_e38b934a-4eef-47e4-9323-1a5fa4fa1cef 68788-7375 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20160823 ANDA ANDA065434 Preferred Pharmaceuticals Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-7376_e5723832-6610-4905-a073-6d17e0ae5e02 68788-7376 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20160823 ANDA ANDA206297 Preferred Pharmaceuticals Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 68788-7377_fd8d9a39-8c4a-41a5-8b1b-522ee6d02348 68788-7377 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160825 ANDA ANDA090705 Preferred Pharmaceuticals Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-7378_bc84051e-3ebe-4b18-b338-7df38c8e48d1 68788-7378 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20160825 ANDA ANDA204314 Preferred Pharmaceuticals Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 68788-7379_2eb90f6c-a5de-472a-98eb-cdc027e74e2e 68788-7379 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil citrate TABLET, FILM COATED ORAL 20160825 ANDA ANDA202503 Preferred Pharmaceuticals Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] E 20171231 68788-7380_1f170a77-8bb8-4c9b-91da-4c6ee7010c09 68788-7380 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20160831 ANDA ANDA078895 Preferred Pharmaceuticals Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68788-7381_a4a790a1-22a3-4b32-bd55-4c80f20b981e 68788-7381 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20141124 ANDA ANDA070044 Preferred Pharmaceuticals Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68788-7382_4c5cce84-e710-458d-b208-ea5c6ac06f21 68788-7382 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20160831 ANDA ANDA204314 Preferred Pharmaceuticals Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 68788-7383_64ca032b-2695-4358-964f-3735f3f1be44 68788-7383 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20160913 ANDA ANDA203154 Preferred Pharmaceuticals Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 68788-7384_8e9dc760-ddd0-49c7-9dd0-f441f22151df 68788-7384 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION/ DROPS OPHTHALMIC 20160907 ANDA ANDA076109 Preferred Pharmaceuticals Inc. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 68788-7385_22eabcd2-456a-4858-aa40-5da547103fa0 68788-7385 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20160907 ANDA ANDA202366 Preferred Pharmaceuticals Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68788-7386_97bfed53-e810-44e4-923f-a7f85b04d4ea 68788-7386 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan potassium TABLET, FILM COATED ORAL 20160908 ANDA ANDA091497 Preferred Pharmaceuticals Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-7387_5741eb27-cd88-45a6-9387-79a80f5a788a 68788-7387 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, CHEWABLE ORAL 20160913 ANDA ANDA203037 Preferred Pharmaceuticals Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68788-7388_b217de67-00d9-40a6-9d8f-d3e4cfc8c097 68788-7388 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20160916 ANDA ANDA078542 Preferred Pharmaceuticals Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68788-7389_5996d35c-bbd8-46fd-9af7-a9c409cca174 68788-7389 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20160926 ANDA ANDA076265 Preferred Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-7390_0ec9601b-258d-4f14-bbf4-2ae2c3b4bae2 68788-7390 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SYRUP ORAL 20160926 ANDA ANDA074454 Preferred Pharmaceuticals Inc. ALBUTEROL SULFATE 2 mg/5mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68788-7391_197ca475-57e6-4553-af31-05428d336aa7 68788-7391 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20160927 ANDA ANDA065326 Preferred Pharmaceuticals Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-7392_f17a35e7-777c-43f7-9300-57f3dbf539b1 68788-7392 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20160928 NDA NDA050662 Preferred Pharmaceuticals Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-7393_e973e057-33f4-406c-bd7d-9e954064b4a6 68788-7393 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20160928 ANDA ANDA075710 Preferred Pharmaceuticals Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 68788-7394_ed55e5a0-8d58-4987-9251-72b30bdd88fc 68788-7394 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20160928 ANDA ANDA077147 Preferred Pharmaceuticals Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-7395_e6af0454-3448-40b8-8616-f8533f641a70 68788-7395 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20160929 ANDA ANDA091672 Preferred Pharmaceuticals Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-7397_fed35a0b-a5fa-4901-952f-a0f8f7cfe01d 68788-7397 HUMAN PRESCRIPTION DRUG Betamethasone Valerate Betamethasone Valerate OINTMENT TOPICAL 20160930 ANDA ANDA070051 Preferred Pharmaceuticals Inc. BETAMETHASONE VALERATE 1.2 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-7398_9f5da412-3c53-4c49-b00d-d8b9fed04bc1 68788-7398 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160930 ANDA ANDA090478 Preferred Pharmaceuticals Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-7399_286a9ecb-bcd6-4edf-89c2-00b5b796ace7 68788-7399 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20160930 ANDA ANDA203088 Preferred Pharmaceuticals Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-7400_ec65737b-d592-4194-a8cf-e6094f168800 68788-7400 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20160930 ANDA ANDA202556 Preferred Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-7401_42ad2625-4184-43a3-9e5e-7bdc1744c54a 68788-7401 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20160930 ANDA ANDA040159 Preferred Pharmaceuticals Inc. MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68788-7402_91a8fc4d-955a-4c0b-980d-a9106411066a 68788-7402 HUMAN OTC DRUG clotrimazole Clotrimazole CREAM TOPICAL 20161010 OTC MONOGRAPH FINAL part333C Preferred Pharmaceuticals Inc. CLOTRIMAZOLE 1 g/100g N 20181231 68788-7403_e1b5c905-7cc2-4b73-b894-ff56754b56a4 68788-7403 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride Olopatadine Hydrochloride 0.1% SOLUTION/ DROPS OPHTHALMIC 20161010 ANDA ANDA204706 Preferred Pharmaceuticals Inc. OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] E 20171231 68788-8911_d5725807-168e-4267-9545-697e46ee6e76 68788-8911 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20150827 ANDA ANDA076822 Preferred Pharmaceuticals Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68788-8912_74e1e9fd-447f-4903-aa8f-6b576750aed7 68788-8912 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20150828 ANDA ANDA202554 Preferred Pharmaceuticals Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-8913_d2d06182-2653-47ea-b96a-08f5700a8970 68788-8913 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20150828 ANDA ANDA090618 Preferred Pharmaceuticals Inc. NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 68788-8914_136de3d9-5e37-4ef6-ba09-e2a749683a33 68788-8914 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150828 ANDA ANDA075994 Preferred Pharmaceuticals Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 68788-8915_44a3dfcb-7cd7-4cc2-baba-d03bbdd53fd7 68788-8915 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20150911 ANDA ANDA090331 Preferred Pharmaceuticals Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68788-8917_019126e8-a67f-49d5-8d06-33b878491dbf 68788-8917 HUMAN PRESCRIPTION DRUG VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20150911 ANDA ANDA090899 Preferred Pharmaceuticals Inc. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-8918_33d9140c-2df3-4f8d-b4c3-aa3de0606413 68788-8918 HUMAN PRESCRIPTION DRUG Acetaminophen, Caffeine, Dihydrocodeine Bitartrate Acetaminophen, Caffeine, Dihydrocodeine Bitartrate CAPSULE ORAL 20150911 ANDA ANDA204785 Preferred Pharmaceuticals Inc. ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 320.5; 30; 16 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 68788-8919_865f4f43-bd98-45b6-8665-e447c4dd1760 68788-8919 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20150918 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 68788-8920_e0389b4a-388f-4c49-a810-d50f8dd3f625 68788-8920 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150918 NDA NDA022370 Preferred Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68788-8921_2d33ccda-4d4f-4f86-b8ac-744135eaba67 68788-8921 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20150922 ANDA ANDA201384 Preferred Pharmaceuticals Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV E 20171231 68788-8923_5daed0a8-c26f-48ef-8d80-d91c3e8f0ea5 68788-8923 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20151006 ANDA ANDA091166 Preferred Pharmaceuticals Inc. ESZOPICLONE 2 mg/1 CIV N 20181231 68788-8924_0b36692a-9e0b-49c0-b48f-e88c0e9b1020 68788-8924 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20151006 NDA AUTHORIZED GENERIC NDA020998 Preferred Pharmaceuticals Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-8925_aa42fdd8-5be0-4c69-9cc4-d94f540ce41e 68788-8925 HUMAN OTC DRUG Adult Low Dose Enteric Coated Aspirin Aspirin TABLET, COATED ORAL 20151006 OTC MONOGRAPH FINAL part343 Preferred Pharmaceuticals Inc. ASPIRIN 81 mg/1 N 20181231 68788-8926_9c68b59c-242a-40b3-86da-0148cc092abb 68788-8926 HUMAN PRESCRIPTION DRUG Methimazole Methimazole TABLET ORAL 20151006 ANDA ANDA040734 Preferred Pharmaceuticals Inc. METHIMAZOLE 5 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 68788-8927_8c50f33b-9639-4b48-a548-d314e119da0c 68788-8927 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20151007 NDA NDA008678 Preferred Pharmaceuticals Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 68788-8928_3b8af4cd-3e7e-412b-b9de-eba5db137e9a 68788-8928 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20151007 ANDA ANDA202556 Preferred Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-8929_441b9e8f-a7ea-4a29-bcd2-6b83c29989de 68788-8929 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20151008 ANDA ANDA078888 PreferredPharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 68788-8930_e72cd7fd-f84d-4e77-baf6-190aaae75787 68788-8930 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20151008 ANDA ANDA070035 Preferred Pharmaceuticals Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68788-8932_4abe23c9-6cb7-4a59-88e0-b3349526bf80 68788-8932 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 19970701 ANDA ANDA074644 Preferred Pharmaceuticals Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 68788-8936_e6e44642-a188-46e2-95b6-db7575e2b416 68788-8936 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20151015 ANDA ANDA200562 Preferred Pharmaceuticals Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-8937_54d91a9e-44d8-4201-a82d-fe948a766808 68788-8937 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20151016 ANDA ANDA078050 Preferred Pharmaceuticals Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 68788-8938_5518a6f5-f8a7-48e1-80a4-4cde28605b70 68788-8938 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20151016 ANDA ANDA076658 Preferred Pharmaceuticals Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68788-8939_a23c53c7-f0c1-4c3f-8d15-7cf7c7350e1c 68788-8939 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20151019 ANDA ANDA065211 Preferred Pharmaceuticals Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-8941_036ebf71-e1a0-416d-bbea-a9df6ce12daa 68788-8941 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20151201 ANDA ANDA090480 Preferred Pharmaceuticals, Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 68788-8942_ab5a00b7-9564-4341-89ef-14a0a29c1e39 68788-8942 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20151029 ANDA ANDA087022 Preferred Pharmaceuticals Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68788-8943_01e8518e-156e-4318-834f-91e1fb4566c8 68788-8943 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20151029 ANDA ANDA075994 Preferred Pharmaceuticals Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-8946_dca995ef-121a-4f7a-897a-7046fd1180e3 68788-8946 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20151027 ANDA ANDA070848 Preferred Pharmaceuticals Inc. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 68788-8947_264af2d7-aa7d-479b-9cf4-e7dd96f36daa 68788-8947 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20151027 ANDA ANDA065212 Preferred Pharmaceuticals Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-8948_da02dfa9-2ce1-4e02-88e3-918f64631e7a 68788-8948 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20151027 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals Inc. HYOSCYAMINE SULFATE .125 mg/1 N 20181231 68788-8949_f66c6ff6-6ddf-4898-84eb-36f33e39e78a 68788-8949 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET ORAL 20040201 ANDA ANDA062935 Preferred Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-8950_09c94d32-738f-4daf-85f7-92e9c7be089b 68788-8950 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20151120 ANDA ANDA087022 Preferred Pharmaceuticals Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68788-8951_72dabe27-acfa-43fa-9c30-9c0e542ee594 68788-8951 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20151120 ANDA ANDA075232 Preferred Pharmaceuticals Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 68788-8952_232fd1e8-4666-47d0-940e-d4f20325a6db 68788-8952 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20151120 ANDA ANDA075185 Preferred Pharmaceuticals Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-8953_6b327320-ad4d-4e66-b74f-0f7c668e38bb 68788-8953 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20151120 ANDA ANDA091113 Preferred Pharmaceuticals Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 68788-8954_68db672f-3dbe-4b59-9ee4-4701a2d7ed57 68788-8954 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 20160104 ANDA ANDA064120 Preferred Pharmaceuticals Inc. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68788-8955_2ba1a460-1109-4513-bfb5-9ba967509c00 68788-8955 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine lidocaine and prilocaine CREAM TOPICAL 20160106 NDA AUTHORIZED GENERIC NDA019941 Preferred Pharmaceuticals Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 68788-8956_88ac5533-b27f-4ece-b009-a61ce6f6cdfd 68788-8956 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium SUSPENSION ORAL 20160104 ANDA ANDA065358 Preferred Pharmaceuticals Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-8958_ee09f4c1-1de8-4b90-a706-ad23021a9cea 68788-8958 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20160104 ANDA ANDA040627 Preferred Pharmaceuticlas Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68788-8962_ebad1991-503e-43e6-aece-17176d7d8956 68788-8962 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20160104 ANDA ANDA078216 Preferred Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-8963_a05bd115-9504-4f8f-b85a-ce6285ff542c 68788-8963 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20160104 ANDA ANDA078423 Preferred Pharmaceuticals Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68788-8964_92233623-965d-42da-b900-712de06c8191 68788-8964 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20160104 ANDA ANDA076899 Preferred Pharmaceuticals Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68788-8965_8089b149-0ab7-4195-abcd-540c6b50e178 68788-8965 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20160104 ANDA ANDA079162 Preferred Pharmaceuticals Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-8967_a6ce422a-bc71-49da-a916-b1b747a2fbb4 68788-8967 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20160111 ANDA ANDA077627 Preferred Pharmaceuticals Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-8968_6794e871-feaa-4d44-9c0e-0f2362bd33ae 68788-8968 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20160111 ANDA ANDA076820 Preferred Pharmaceuticals Inc. BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-8969_51aa6e1b-4173-4737-9efa-7741ec4cd0ea 68788-8969 HUMAN PRESCRIPTION DRUG Celecoxib 200 mg CELECOXIB CAPSULE ORAL 20160108 ANDA ANDA204519 Preferred Pharmaceuticals Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-8970_0cb26be8-968b-4821-94a2-2b75526ba534 68788-8970 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20160111 ANDA ANDA076410 Preferred Pharmaceuticals Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 68788-8971_a35dd27f-f1a4-4ad0-a785-b92833906a26 68788-8971 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20160120 ANDA ANDA076410 Preferred Pharmaceuticals Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 68788-8972_016d88f2-7322-450f-a0c1-8fc89253582b 68788-8972 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20160120 ANDA ANDA065271 Preferred Pharmaceuticals Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-8977_59cded0a-0f43-4226-a535-59564650db7d 68788-8977 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20160120 ANDA ANDA065256 Preferred Pharmaceuticals Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-8980_da86901b-d77e-494e-bae6-6abf9d7d3444 68788-8980 HUMAN OTC DRUG Preferred Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20160615 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals Inc. PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 68788-8985_c6e287b7-507f-410a-a1d4-de617fce529c 68788-8985 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM VAGINAL 20160201 ANDA ANDA074444 Preferred Pharmaceuticals Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 68788-8986_fa760ce7-559f-4129-8264-0d818cc020f8 68788-8986 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20160201 ANDA ANDA065326 Preferred Pharmaceuticals Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-8987_dadcde9b-878b-4402-a6ce-0627974952a8 68788-8987 HUMAN OTC DRUG rugby all day relief Naproxen Sodium TABLET ORAL 20160201 ANDA ANDA074661 Preferred Pharmaceuticals Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 68788-8988_83415087-ed71-403a-b111-b3ac0959e179 68788-8988 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, CHEWABLE ORAL 20160201 ANDA ANDA091588 Preferred Pharmaceuticals Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68788-8989_23fc147d-0df8-4f63-ba32-924a1b759410 68788-8989 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20160201 ANDA ANDA077309 Preferred Pharmaceuticals Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 68788-8990_3ff4c238-6c25-450c-8ca7-4996a42ea23a 68788-8990 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20160216 ANDA ANDA065435 Preferred Pharmaceuticals Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-8991_b8bbe9fd-5169-484e-b51e-815b71ce10c7 68788-8991 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160216 ANDA ANDA090548 Preferred Pharmaceuticals Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-8992_1ee403fb-079e-4dc3-a6af-921be035ef7e 68788-8992 HUMAN OTC DRUG Childrens Cetirizine Hydrochloride Sugar Free Grape Cetirizine Hydrochloride SOLUTION ORAL 20160215 ANDA ANDA090182 Preferred Pharmaceuticals Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 68788-8993_809b3fd8-1076-401f-bda2-f94ec5f5332a 68788-8993 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION OPHTHALMIC 20160215 ANDA ANDA078559 Preferred Pharmaceuticals Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-8994_f66c83ef-f160-4cea-99e3-f19bf92b41dd 68788-8994 HUMAN PRESCRIPTION DRUG Cephalexin cephalexin CAPSULE ORAL 20160211 ANDA ANDA062713 Preferred Pharmaceuticals Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-8996_dd11ff9f-a419-428e-b20d-ba9cb97b041b 68788-8996 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20160211 ANDA ANDA065098 Preferred Pharmaceuticals Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 200; 28.5 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-8997_e5c27d13-607d-4097-907a-f83b5282adf0 68788-8997 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole TABLET, DELAYED RELEASE ORAL 20160211 ANDA ANDA204179 Preferred Pharmaceuticals Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68788-8999_ab6c8a12-54c2-44de-8ab1-9d11cb29077b 68788-8999 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130604 ANDA ANDA202176 Preferred Pharmaceuticals, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68788-9004_c41141b2-c7c9-4747-b258-f540826a4d29 68788-9004 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20110608 ANDA ANDA076847 Preferred Pharmaceuticals, Inc SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68788-9005_c41141b2-c7c9-4747-b258-f540826a4d29 68788-9005 HUMAN PRESCRIPTION DRUG Sumatriptan Succinate Sumatriptan Succinate TABLET ORAL 20110608 ANDA ANDA076847 Preferred Pharmaceuticals, Inc SUMATRIPTAN SUCCINATE 100 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68788-9006_01fc28bb-ec1a-4093-b2f5-10d7eac19282 68788-9006 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20110614 ANDA ANDA075593 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-9009_9970b3e1-484a-4c49-a56d-2ef9ffac3d07 68788-9009 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20110609 ANDA ANDA040218 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-9012_0b6ec532-766f-488c-afb4-9a19b66aa232 68788-9012 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-9013_f550e2c7-f98f-4dbf-b062-ed4829b6443f 68788-9013 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-9014_f550e2c7-f98f-4dbf-b062-ed4829b6443f 68788-9014 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-9015_f550e2c7-f98f-4dbf-b062-ed4829b6443f 68788-9015 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-9016_f550e2c7-f98f-4dbf-b062-ed4829b6443f 68788-9016 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085967 Preferred Pharmaceuticals, Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-9017_f04e0115-4197-4a9e-8790-93416c9c824e 68788-9017 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20110615 ANDA ANDA065322 Preferred Pharmaceuticals, Inc. AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9018_f04e0115-4197-4a9e-8790-93416c9c824e 68788-9018 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20110615 ANDA ANDA065325 Preferred Pharmaceuticals, Inc. AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9019_f04e0115-4197-4a9e-8790-93416c9c824e 68788-9019 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20110615 ANDA ANDA065322 Preferred Pharmaceuticals, Inc. AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9021_3287fbdd-c0d7-4e21-83e1-f059023e01e9 68788-9021 HUMAN PRESCRIPTION DRUG SULFASALAZINE SULFASALAZINE TABLET ORAL 20100609 ANDA ANDA087197 Preferred Pharmaceuticals, Inc SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 68788-9022_68d1428e-77ee-4845-ba3e-1c9148c261d2 68788-9022 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20070426 ANDA ANDA078432 Preferred Pharmaceuticals, Inc. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68788-9023_744ef3f2-fe56-43ac-99bc-5d868579d0a5 68788-9023 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Preferred Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-9024_01fc28bb-ec1a-4093-b2f5-10d7eac19282 68788-9024 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA075593 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-9025_8892e774-a967-4fc7-98c1-d9e2eaa35e95 68788-9025 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen and Caffeine TABLET ORAL 19950612 ANDA ANDA089718 Preferred Pharmaceuticals, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68788-9026_fbe5333d-ca19-433a-90a5-e3aeecdd01b7 68788-9026 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Preferred Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-9027_fbe5333d-ca19-433a-90a5-e3aeecdd01b7 68788-9027 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Preferred Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-9032_11f5d0c7-4933-4d96-b974-ed1f985b9ae5 68788-9032 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100101 ANDA ANDA065291 Preferred Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9033_11f5d0c7-4933-4d96-b974-ed1f985b9ae5 68788-9033 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20100101 ANDA ANDA065291 Preferred Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9035_91673b23-61a8-48a1-b4df-678058f90d08 68788-9035 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20110725 ANDA ANDA065334 Preferred Pharmaceuticals, Inc. AMOXICILLIN 400 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9037_df059053-bf93-4b78-877f-02359fbe3647 68788-9037 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 20110609 ANDA ANDA062396 Preferred Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68788-9038_c6d3d238-49e9-47e9-ad7e-28291292320a 68788-9038 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 19960718 NDA AUTHORIZED GENERIC NDA050711 Preferred Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9041_69f9189d-bf53-4960-b754-885e00331551 68788-9041 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 20130509 ANDA ANDA073665 Preferred Pharmaceuticals, Inc. ATENOLOL; CHLORTHALIDONE 100; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 68788-9042_d36fd806-74ef-4266-9d3e-45a2ce340fbb 68788-9042 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone Atenolol and Chlorthalidone TABLET ORAL 20130509 ANDA ANDA073665 Preferred Pharmaceuticals, Inc. ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 68788-9043_382652df-7a03-4b54-a7a3-1d58cdc15d27 68788-9043 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120125 ANDA ANDA065096 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-9045_53f34eef-7876-409b-843f-711b4851255d 68788-9045 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin Monohydrate POWDER, FOR SUSPENSION ORAL 20110310 ANDA ANDA065419 Preferred Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9046_53f34eef-7876-409b-843f-711b4851255d 68788-9046 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin Monohydrate POWDER, FOR SUSPENSION ORAL 20110310 ANDA ANDA065419 Preferred Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9047_ca7c902e-d536-4dad-8028-79a426fe12c9 68788-9047 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Preferred Pharmaceuticals, Inc. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-9048_ca7c902e-d536-4dad-8028-79a426fe12c9 68788-9048 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Preferred Pharmaceuticals, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-9049_ca7c902e-d536-4dad-8028-79a426fe12c9 68788-9049 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20071204 ANDA ANDA077877 Preferred Pharmaceuticals, Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-9050_df5ded76-c630-468b-a3f3-89f5df9efd30 68788-9050 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Preferred Pharmaceuticals, Inc BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-9051_df5ded76-c630-468b-a3f3-89f5df9efd30 68788-9051 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Preferred Pharmaceuticals, Inc BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-9052_df5ded76-c630-468b-a3f3-89f5df9efd30 68788-9052 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Preferred Pharmaceuticals, Inc BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-9053_df5ded76-c630-468b-a3f3-89f5df9efd30 68788-9053 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20100906 ANDA ANDA076118 Preferred Pharmaceuticals, Inc BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-9054_ea71dafd-ae50-41b7-8ad9-d88dfe4f42a4 68788-9054 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE ORAL 20080407 ANDA ANDA040587 Preferred Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68788-9055_382652df-7a03-4b54-a7a3-1d58cdc15d27 68788-9055 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20120125 ANDA ANDA065101 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9064_ec9b2ab1-bfd2-4ba6-b2cc-1cac488a0f30 68788-9064 HUMAN PRESCRIPTION DRUG Cimetidine Cimetidine TABLET, FILM COATED ORAL 20110706 ANDA ANDA074151 Preferred Pharmaceuticals, Inc. CIMETIDINE 400 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68788-9066_f8ad8c0b-99de-41f8-97ec-a2a504df29a7 68788-9066 HUMAN OTC DRUG Cheratussin AC codeine phosphate and guaifenesin LIQUID ORAL 19960901 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV N 20181231 68788-9067_62df785d-02d4-4e3d-8f65-c0ac82f7d2eb 68788-9067 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20110705 ANDA ANDA076925 Preferred Pharmaceuticals, Inc. IBUPROFEN 100 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9069_7a39db56-4621-461b-b8ee-c829cf6f2595 68788-9069 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20110707 ANDA ANDA077797 Preferred Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-9072_2eaa3b08-b2ff-45c2-9739-6732e60c6438 68788-9072 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20050628 ANDA ANDA065148 Preferred Pharmaceuticals, Inc NYSTATIN 100000 [USP'U]/mL Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 68788-9074_2e498d1c-964b-4349-8c90-c33befeb39d1 68788-9074 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Preferred Pharmaceuticals, Inc PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9075_a270eb9b-66fe-4461-b209-125cd93fbd9f 68788-9075 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20100806 ANDA ANDA040489 Preferred Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-9076_a270eb9b-66fe-4461-b209-125cd93fbd9f 68788-9076 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20100806 ANDA ANDA040489 Preferred Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-9077_c33b9e63-0222-4ef6-8c11-1f7eecb5e30a 68788-9077 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065404 Preferred Pharmaceuticals, Inc. AZITHROMYCIN ANHYDROUS 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9078_c33b9e63-0222-4ef6-8c11-1f7eecb5e30a 68788-9078 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20080211 ANDA ANDA065405 Preferred Pharmaceuticals, Inc. AZITHROMYCIN ANHYDROUS 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9079_32654817-0c54-4a71-8a31-9a73c5ecaf97 68788-9079 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20110128 ANDA ANDA073192 Preferred Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 68788-9080_0e0948db-b326-4bc3-b2c2-82d3fc628bb9 68788-9080 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20081015 ANDA ANDA076301 Preferred Pharmaceuticals, Inc. LORATADINE 10 mg/1 N 20181231 68788-9081_10360f95-ef8e-4279-9c46-31708c8bf7d9 68788-9081 HUMAN OTC DRUG Q-Tussin Guaifenesin SOLUTION ORAL 19971001 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc GUAIFENESIN 100 mg/5mL N 20181231 68788-9082_aca524d4-3cfe-4815-8caa-8822388f24c1 68788-9082 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070027 Preferred Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68788-9083_aca524d4-3cfe-4815-8caa-8822388f24c1 68788-9083 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20100901 ANDA ANDA070033 Preferred Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68788-9085_5bfa1a86-7564-4db9-abf6-7f118eea1fdb 68788-9085 HUMAN PRESCRIPTION DRUG Minocycline hydrochloride Minocycline hydrochloride CAPSULE ORAL 20001222 ANDA ANDA065062 Preferred Pharmaceuticals, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 68788-9086_ca1c3cb2-35a5-411d-8a71-f731396b20eb 68788-9086 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 Preferred Pharmaceuticals, Inc SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68788-9087_f29d91c8-332c-4069-ac66-3834c1ee2172 68788-9087 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20051005 ANDA ANDA065136 Preferred Pharmaceuticals, Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 68788-9088_ce5f935a-2785-43af-9acb-1783907bdeeb 68788-9088 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20110118 ANDA ANDA073517 Preferred Pharmaceuticals, Inc. KETOPROFEN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9089_9a5dac59-a9f2-48fc-a298-daf995c8945f 68788-9089 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET ORAL 20050303 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68788-9091_f6e7c4af-3900-4c54-bfff-662cd4da075a 68788-9091 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Preferred Pharmaceuticals, Inc TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 68788-9092_f6e7c4af-3900-4c54-bfff-662cd4da075a 68788-9092 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20020703 ANDA ANDA076286 Preferred Pharmaceuticals, Inc TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 68788-9093_c699522c-f5da-4414-bd2b-c93a2583bd4c 68788-9093 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20090313 ANDA ANDA078807 Preferred Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 68788-9094_5831d093-9a92-43c2-a384-1ba1537dbcf7 68788-9094 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20110629 ANDA ANDA077919 Preferred Pharmaceuticals, Inc TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] E 20171231 68788-9095_851fa1b0-376d-4944-80d8-eae96a24c132 68788-9095 HUMAN OTC DRUG Qdryl Allergy Diphenhydramine Hydrochloride SOLUTION ORAL 19971201 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 68788-9096_1cfae991-2b64-4564-b3b4-f3b25d07e1bb 68788-9096 HUMAN PRESCRIPTION DRUG Prednisolone Prednisolone SOLUTION ORAL 20030227 ANDA ANDA040401 Preferred Pharmaceuticals, Inc PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9097_ebf9948e-3109-4c5c-9326-579765b74b17 68788-9097 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SOLUTION ORAL 20060214 ANDA ANDA040649 Preferred Pharmaceuticals, Inc. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68788-9098_7a430218-0489-473d-91a5-65e6cab90d63 68788-9098 HUMAN OTC DRUG Siltussin SA Guaifenesin LIQUID ORAL 19981005 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc GUAIFENESIN 100 mg/5mL N 20181231 68788-9100_b00b296d-6c34-48c8-9cfb-71ccc5c9a908 68788-9100 HUMAN PRESCRIPTION DRUG Promethazine VC Promethazinehydrochloride and phenylephrine hydrochloride SYRUP ORAL 20061207 ANDA ANDA040654 Preferred Pharmaceuticals, Inc PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 6.25; 5 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] E 20171231 68788-9101_733fb3e7-057c-4658-bac2-160f0704cadf 68788-9101 HUMAN OTC DRUG Q Tussin DM Dextromethorphan HBr and Guaifenesin SYRUP ORAL 19950401 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 68788-9102_dbd7c8c8-2a47-491c-8218-1fcc3d3a1acf 68788-9102 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20040806 ANDA ANDA074650 Preferred Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68788-9103_748c9946-8dc6-4933-8d9d-a8e959185629 68788-9103 HUMAN OTC DRUG Siltussin DM Guaifenesin and Dextromethorphan Hydrobromide LIQUID ORAL 19920905 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 100; 10 mg/5mL; mg/5mL N 20181231 68788-9107_f04e38e9-0402-4845-84dd-ab698ccc2bf0 68788-9107 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 NDA NDA018851 Preferred Pharmaceuticals, Inc. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9108_f04e38e9-0402-4845-84dd-ab698ccc2bf0 68788-9108 HUMAN PRESCRIPTION DRUG INDOMETHACIN indomethacin CAPSULE ORAL 20100730 NDA NDA018851 Preferred Pharmaceuticals, Inc. INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9109_db941113-9c5f-41b5-9ba9-e329a9e01310 68788-9109 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20110824 ANDA ANDA074916 Preferred Pharmaceuticals, Inc IBUPROFEN 100 mg/5mL N 20181231 68788-9110_700ba27e-4bbb-45e3-8b74-77e5294102e5 68788-9110 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Preferred Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9111_700ba27e-4bbb-45e3-8b74-77e5294102e5 68788-9111 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Preferred Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9112_700ba27e-4bbb-45e3-8b74-77e5294102e5 68788-9112 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Preferred Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9113_3b773161-b2ab-4d89-a672-7b4d6debe383 68788-9113 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Preferred Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9114_3b773161-b2ab-4d89-a672-7b4d6debe383 68788-9114 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Preferred Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9115_3b773161-b2ab-4d89-a672-7b4d6debe383 68788-9115 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Preferred Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9116_56fa6109-36fa-41c7-87cc-69f26e4ce24f 68788-9116 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20040830 ANDA ANDA087425 Preferred Pharmaceuticals, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 68788-9117_87a3a45f-0e98-4986-bc0c-08406bb4d81c 68788-9117 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 20110531 ANDA ANDA075273 Preferred Pharmaceuticals, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-9118_3bfa57cf-44e1-4cef-ada0-79146cf41b20 68788-9118 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20070725 ANDA ANDA078406 Preferred Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9120_ffb1e5ed-d01d-405e-be48-345b63ca5742 68788-9120 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone neomycin sulfate, polymyxin b sulfate and dexamethasone SUSPENSION OPHTHALMIC 20110830 ANDA ANDA062341 Preferred Pharmaceuticals, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9121_c8a88bc0-7b98-4772-87e7-3336df20bc56 68788-9121 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-9122_c8a88bc0-7b98-4772-87e7-3336df20bc56 68788-9122 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-9124_260b560d-94c7-42f7-bedd-5f42972f2b12 68788-9124 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET ORAL 19940325 ANDA ANDA040353 Preferred Pharmaceuticals, Inc SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 68788-9125_8f7af58a-d68f-4fe6-b39c-1ca0863b1bb8 68788-9125 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20110901 ANDA ANDA040656 Preferred Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 68788-9126_2f233d49-32aa-409e-8584-fee85525fe3e 68788-9126 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Preferred Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 68788-9127_2f233d49-32aa-409e-8584-fee85525fe3e 68788-9127 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Preferred Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 68788-9128_b0abd953-5e39-4354-9c0f-0de17f9d06ee 68788-9128 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20050628 ANDA ANDA076716 Preferred Pharmaceuticals, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-9129_e7ac0593-37ad-45e8-b458-a2b12a6b9d2b 68788-9129 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20040721 20190410 ANDA ANDA087479 Preferred Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68788-9133_6f5247aa-1371-4b39-b0f3-9d869e36d138 68788-9133 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20140102 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals, Inc. IBUPROFEN 200 mg/1 N 20181231 68788-9135_302044b1-17c7-4ce8-a2ed-2c54673daaf6 68788-9135 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19771117 ANDA ANDA085762 Preferred Pharmaceuticals, Inc. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 68788-9137_5d197f41-61d0-47e2-9534-729658affbd4 68788-9137 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20090909 ANDA ANDA040655 Preferred Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 68788-9138_21236514-2661-4fad-9e4c-35f6fcd553e8 68788-9138 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Preferred Pharmaceuticals, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-9141_30435f4e-4f55-4f13-b611-86bce89a4c98 68788-9141 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 20110722 ANDA ANDA040355 Preferred Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 68788-9149_6479b7bc-3e77-4c26-94db-deaea9dc1fbb 68788-9149 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20110101 ANDA ANDA077836 Preferred Pharmaceuticals, Inc GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 68788-9150_0f50125a-6d89-4b2b-b48b-daac6129182c 68788-9150 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 19980619 ANDA ANDA040284 Preferred Pharmaceuticals, Inc ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 68788-9151_92aaaf46-34b4-4ff4-8bd8-79942ff7de06 68788-9151 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Preferred Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9152_8f5f2cbd-66a6-4eb8-abe0-f6d09fbc2411 68788-9152 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20050923 ANDA ANDA065170 Preferred Pharmaceuticals, Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20191231 68788-9155_f8c3fddd-8010-4c10-8200-a490640705b1 68788-9155 HUMAN OTC DRUG Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20090317 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. OXYMETAZOLINE HYDROCHLORIDE 5 g/100mL N 20181231 68788-9156_f45b3180-0ad8-45b1-8aa3-46dabc15d1ef 68788-9156 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .125 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9157_4137bc35-a1c5-4aa4-9398-1b20f6c5ce80 68788-9157 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .15 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9159_b48b8776-184d-438c-8698-a1d8907cc704 68788-9159 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20031201 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .2 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9160_c100f41b-5077-45af-8364-d9d12b934154 68788-9160 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .025 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9161_06e3ca6f-c1f1-48c6-9d9b-a829c03ab437 68788-9161 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .05 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9162_b7acd7ee-0bb8-43fe-ae74-bac2adcdb0b5 68788-9162 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .075 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9163_92071f54-09f8-4a9b-81cf-ba2ebc09ea6b 68788-9163 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .088 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9164_6d8faad8-8a8d-4622-a1d5-f5bc2c9d8f39 68788-9164 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .1 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9165_ff0199f8-0111-4ce9-84c9-8fe9265960b5 68788-9165 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .112 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9168_1087a997-1d95-4d4c-9ce8-6391f16aebc9 68788-9168 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20090909 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .175 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9172_0be500d6-e8cb-46e9-9335-99a725e8bddd 68788-9172 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20080610 ANDA ANDA086414 Preferred Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9175_09a07de5-161d-4e1d-96b3-7f269b2e364f 68788-9175 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20101231 ANDA ANDA090066 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68788-9176_2080ddca-9cf9-477b-b48a-ec5936538bb0 68788-9176 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20110425 ANDA ANDA074305 Preferred Pharmaceuticals,Inc. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68788-9177_63c639a0-1311-4e0b-b4e8-f44713771a06 68788-9177 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20110721 ANDA ANDA040256 Preferred Pharmaceuticals, Inc. PREDNISONE 5 mg/1 N 20181231 68788-9178_dfd739a4-fa3b-46ee-96b1-5c27987ef5c4 68788-9178 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20110721 ANDA ANDA040256 Preferred Pharmaceuticals, Inc. PREDNISONE 10 mg/1 N 20191231 68788-9179_a7fbd41c-e190-45cb-bccd-a2dbf4a23b63 68788-9179 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20110721 ANDA ANDA040392 Preferred Pharmaceuticals, Inc. PREDNISONE 20 mg/1 N 20181231 68788-9180_9069b3a6-2840-44b0-994d-797c038a1f38 68788-9180 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20051027 ANDA ANDA075828 Preferred Pharmaceuticals, Inc LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 68788-9181_84e34b24-b38d-4c7a-ac35-1542df41185b 68788-9181 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20051027 ANDA ANDA075828 Preferred Pharmaceuticals, Inc LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 68788-9182_10732fde-1cf5-4001-8c92-e7df59db22fa 68788-9182 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20051027 ANDA ANDA075828 Preferred Pharmaceuticals, Inc LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 68788-9183_884cbae5-e2cb-4513-a664-84fc2bd03ada 68788-9183 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 19730919 ANDA ANDA083426 Preferred Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68788-9184_5d5688d6-3a0e-4014-9c97-282ccd9471ca 68788-9184 HUMAN OTC DRUG Q-Tapp Brompheniramine maleate and Pseudoephedrine hydrochloride ELIXIR ORAL 20010405 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE 1; 15 mg/5mL; mg/5mL E 20171231 68788-9185_23e0a59a-5f82-4acf-a160-0507259edb08 68788-9185 HUMAN PRESCRIPTION DRUG Diclofenac Sodium diclofenac sodium TABLET, DELAYED RELEASE ORAL 20100518 ANDA ANDA075281 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9190_0285bdcd-02ce-4be5-94a3-f851a4fd33a2 68788-9190 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20141027 ANDA ANDA077253 Preferred Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68788-9196_ee1a2cac-0593-41c6-868d-0016414e4205 68788-9196 HUMAN OTC DRUG Extra Strength QPAP Acetaminophen TABLET ORAL 20111103 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 68788-9199_c7c19978-abae-41e9-bc98-be537cb66676 68788-9199 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20091123 ANDA ANDA076003 Preferred Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV E 20171231 68788-9203_000233b6-5d67-4fd3-b9d5-953c9ba3786a 68788-9203 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19960718 ANDA ANDA064030 Preferred Pharmaceuticals, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9204_372c1c5a-3148-415d-95ae-13ed6f2726fc 68788-9204 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20130514 ANDA ANDA076622 Preferred Pharmaceuticals, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-9205_e18bf0d7-044d-4121-b614-abd4d07744a4 68788-9205 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20150121 ANDA ANDA074754 Preferred Pharmaceuticals, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 68788-9207_91b3ba3d-f222-411d-9d25-1165a9dc7437 68788-9207 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20111109 ANDA ANDA071322 Preferred Pharmaceuticals, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9208_91b3ba3d-f222-411d-9d25-1165a9dc7437 68788-9208 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20111109 ANDA ANDA071321 Preferred Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9212_732df59a-1647-4346-a09c-45715b735e82 68788-9212 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20111110 ANDA ANDA070974 Preferred Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68788-9213_4d4e84d7-ac07-47a9-9ec9-d11b19e72cfa 68788-9213 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20111110 ANDA ANDA070975 Preferred Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68788-9214_272ead3f-5347-44fe-9e94-82e33bb07d49 68788-9214 HUMAN PRESCRIPTION DRUG CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET ORAL 20111110 ANDA ANDA070925 Preferred Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68788-9215_7c59f4be-f814-4952-864a-628076200cab 68788-9215 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20141110 ANDA ANDA087022 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68788-9216_b5886f34-37f8-4200-b320-194a712e6da7 68788-9216 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20150827 ANDA ANDA090937 Preferred Pharmaceuticals Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 68788-9217_0924fbae-9e90-45f8-ac2e-3f8bd4e83d41 68788-9217 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20150826 ANDA ANDA075805 Preferred Pharmaceuticals Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68788-9218_b27c9426-573c-411b-8500-5d3404e7269c 68788-9218 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 20141008 ANDA ANDA040183 Preferred Pharmaceuticals, Inc. METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9219_0a35719c-002d-4a92-8515-83e5cff6b63b 68788-9219 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20140919 ANDA ANDA076592 Preferred Pharmaceuticals, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9220_5842f9a5-9a5d-426b-aefb-9b8d5c979469 68788-9220 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20010416 ANDA ANDA075718 Preferred Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68788-9221_0b09e8d5-e8e3-4dd3-84ff-62cde05a8b92 68788-9221 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20141013 NDA NDA021342 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9222_2f240ed3-d23d-4ea7-8007-446786ebf461 68788-9222 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Preferred Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9223_48da1bf1-401d-456a-b491-a2ddf093da02 68788-9223 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20080131 ANDA ANDA078619 Preferred Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9224_2bc29e76-a17a-4353-97c0-55fa62ba242e 68788-9224 HUMAN OTC DRUG PHAZYME Simethicone CAPSULE, GELATIN COATED ORAL 20141014 OTC MONOGRAPH FINAL part332 Preferred Pharmaceuticals, Inc. DIMETHICONE 180 mg/1 N 20181231 68788-9226_fd3ac5d4-f240-4f3d-a76f-67702a92feca 68788-9226 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20090129 ANDA ANDA078010 Preferred Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 68788-9227_37345e4c-d6bb-4a90-98bf-1247c6f72251 68788-9227 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20141017 ANDA ANDA089424 Preferred Pharmaceuticals, Inc. SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68788-9228_b71fe02d-a9bd-49c7-8b02-5f898e958f22 68788-9228 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20141112 ANDA ANDA077859 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-9229_19688c75-29e0-4bd1-a99b-fb4e1313740c 68788-9229 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20141016 ANDA ANDA202800 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 68788-9231_09a07de5-161d-4e1d-96b3-7f269b2e364f 68788-9231 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68788-9232_3a9fcc26-b281-4720-a3b6-fe7ff54f6e0f 68788-9232 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20141006 ANDA ANDA201384 Preferred Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 300 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68788-9233_91b3473d-b95b-4b7d-a1d4-3ff2cb75a9b9 68788-9233 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate INJECTION, SUSPENSION INTRAMUSCULAR 19921029 NDA AUTHORIZED GENERIC NDA020246 Preferred Pharmaceuticals, Inc MEDROXYPROGESTERONE ACETATE 150 mg/mL Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 68788-9234_0b09e8d5-e8e3-4dd3-84ff-62cde05a8b92 68788-9234 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20141013 NDA NDA021342 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9235_0b09e8d5-e8e3-4dd3-84ff-62cde05a8b92 68788-9235 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20141013 NDA NDA021342 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 75 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9236_b9aa9629-5e5d-42bd-94ac-8f549458c16e 68788-9236 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20141009 ANDA ANDA073025 Preferred Pharmaceuticals, Inc. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-9237_3a9fcc26-b281-4720-a3b6-fe7ff54f6e0f 68788-9237 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20141006 ANDA ANDA201384 Preferred Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68788-9238_e62eb656-fd3a-47ec-8836-40387dd80ef2 68788-9238 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20141013 ANDA ANDA091153 Preferred Pharmaceuticals, Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 68788-9245_bc97c079-3bd8-495c-ac63-7d7c92540b0f 68788-9245 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20141027 ANDA ANDA077731 Preferred Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 68788-9246_4811c68d-ad8a-46f7-bf8b-6b51ef27a0ed 68788-9246 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20141022 ANDA ANDA078220 Preferred Pharmaceuticals, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68788-9247_d1fd3424-58fa-4f36-b4e4-f274f3a48751 68788-9247 HUMAN PRESCRIPTION DRUG nystatin nystatin CREAM TOPICAL 20141113 ANDA ANDA062129 Preferred Pharmaceuticals, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 68788-9249_063010ce-fec3-4d09-8ae3-b5a71685f5e8 68788-9249 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20141120 ANDA ANDA091643 Preferred Pharmaceuticals, Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68788-9250_8937086b-01f9-4c79-91ba-f3283cdede18 68788-9250 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141103 ANDA ANDA040736 Preferred Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 68788-9254_f68b10d6-dc40-416c-8d56-875bd8c0e18d 68788-9254 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20141201 ANDA ANDA077056 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68788-9255_8c983738-a207-42be-a13e-396457e10ef1 68788-9255 HUMAN PRESCRIPTION DRUG bupropion bupropion TABLET, EXTENDED RELEASE ORAL 20141103 ANDA ANDA201567 Preferred Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68788-9256_8eb235b2-971d-423c-99ae-0bb9be24ad85 68788-9256 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20150223 ANDA ANDA040865 Preferred Pharmaceuticals, Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 68788-9258_ba8d01c4-4db5-49ac-b82c-cb29060c79f3 68788-9258 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20150827 ANDA ANDA071403 Preferred Pharmaceuticals Inc. LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9259_3e9c2bd7-bdfa-43c8-acc9-c11cea938b1d 68788-9259 HUMAN PRESCRIPTION DRUG Acetaminophen And Codeine acetaminophen and codeine phosphate TABLET ORAL 20141113 ANDA ANDA089828 Preferred Pharmaceuticals, Inc. CODEINE PHOSPHATE; ACETAMINOPHEN 60; 300 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 68788-9260_250e233c-367d-4849-844e-a91f9c48f744 68788-9260 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20150513 ANDA ANDA065435 Preferred Pharmaceuticals Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9261_327cc682-2b89-4d43-9bfe-51edd1c6c288 68788-9261 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED ORAL 20141111 ANDA ANDA077184 Preferred Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68788-9262_01ae8777-f85f-4d13-9ec6-b068565b893e 68788-9262 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20141125 ANDA ANDA090778 Preferred Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9263_f68b10d6-dc40-416c-8d56-875bd8c0e18d 68788-9263 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20141201 ANDA ANDA077056 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68788-9264_11be25d5-3071-4449-b27c-b898b005b771 68788-9264 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20131113 ANDA ANDA040755 Preferred Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 68788-9265_f5ca4b7d-15c4-45ea-8354-27df3e2d0517 68788-9265 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20141203 ANDA ANDA077614 Preferred Pharmaceuticals,Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68788-9266_a1c8f11e-c793-4bfb-ae9b-c17082d6491c 68788-9266 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE PELLETS ORAL 20141118 ANDA ANDA090723 Preferred Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9267_19905fcc-b599-47e6-8815-8db90ba985b0 68788-9267 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen tramadol hydrochloride and acetaminophen TABLET, FILM COATED ORAL 20141223 ANDA ANDA077858 Preferred Pharmaceuticals, Inc. TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68788-9268_efeed6ce-b186-4ace-b635-462db24f6a67 68788-9268 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150108 ANDA ANDA076710 Preferred Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 68788-9269_5deef2ef-e687-4c6f-94f7-525809ee652c 68788-9269 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20150101 ANDA ANDA090763 Preferred Pharmaceuticals, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68788-9270_d4f933ef-9d4a-4f16-a853-e2d3229175bb 68788-9270 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20140102 ANDA ANDA091179 Preferred Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68788-9271_bb39a784-d025-424f-b066-f5e0d5c3564c 68788-9271 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20141222 ANDA ANDA040555 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68788-9273_a73933ec-fc09-4b38-934c-a97af35eda18 68788-9273 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141222 NDA AUTHORIZED GENERIC NDA020998 Preferred Pharmaceuticals, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9274_a73933ec-fc09-4b38-934c-a97af35eda18 68788-9274 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20141222 NDA AUTHORIZED GENERIC NDA020998 Preferred Pharmaceuticals, Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9275_6fc039a9-1e59-4468-b1d6-0a1712bf1e8f 68788-9275 HUMAN PRESCRIPTION DRUG Rabeprazole sodium Rabeprazole sodium TABLET, DELAYED RELEASE ORAL 20150513 ANDA ANDA202376 Preferred Pharmaceuticals Inc. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68788-9277_138d9c2c-1931-4456-81a7-4327a1379037 68788-9277 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20150106 ANDA ANDA203399 Preferred Pharmaceuticals, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 68788-9278_4e49492c-684c-4246-8534-a04e4f091ca7 68788-9278 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20150223 ANDA ANDA076578 Preferred Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 68788-9279_1a1aa912-b369-45f9-9627-d8fa9abe658c 68788-9279 HUMAN PRESCRIPTION DRUG ipratropium bromide and albuterol sulfate ipratropium bromide and albuterol sulfate SOLUTION RESPIRATORY (INHALATION) 20150302 ANDA ANDA202496 Preferred Pharmaceuticals, Inc. IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 2.5 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68788-9280_0b6ec532-766f-488c-afb4-9a19b66aa232 68788-9280 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20150129 ANDA ANDA076639 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-9281_0a7dbc58-480c-41b3-bfac-fb3ceadcc3a6 68788-9281 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 Preferred Pharmaceuticals, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68788-9282_4c030a9c-f2b7-4d19-a506-61c650db375b 68788-9282 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20150223 ANDA ANDA078413 Preferred Pharmaceuticals, Inc. ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 68788-9285_037f636d-f367-4395-9ce2-26f920839c6a 68788-9285 HUMAN OTC DRUG Simethicone Simethicone CAPSULE, LIQUID FILLED ORAL 20150203 OTC MONOGRAPH FINAL part332 Preferred Pharmaceuticals, Inc. DIMETHICONE 180 mg/1 N 20181231 68788-9286_c5f5418a-cd95-45b4-8e23-5f9518caa8c0 68788-9286 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20150113 ANDA ANDA076670 Preferred Pharmaceuticals, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-9287_96039a14-2169-498b-b23d-4c3be6cbf3e1 68788-9287 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20150508 ANDA ANDA088616 Preferred Pharmaceuticals Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68788-9288_2d4c58bd-ec20-4b81-b9a7-07bee5c8d11b 68788-9288 HUMAN OTC DRUG LidoPro Capsaicin, Lidocaine, Menthol, and Methyl Salicylate OINTMENT TOPICAL 20150203 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .000325; .04; .1; .275 g/g; g/g; g/g; g/g N 20181231 68788-9289_36df24b9-b69f-4a84-b366-5606851d9adc 68788-9289 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20150202 ANDA ANDA065435 Preferred Pharmaceuticals, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9290_13ec3c2c-4ba5-4980-b630-f1bfaef22012 68788-9290 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20150302 ANDA ANDA201089 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM; MISOPROSTOL 75; 200 mg/1; ug/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 68788-9291_e183c62c-43e6-49a6-8c00-bc0284cd6e0a 68788-9291 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 20150513 ANDA ANDA040317 Preferred Pharmaceuticals Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68788-9292_1f74ffc4-0930-4c0b-9e0b-9fdfcc87e18e 68788-9292 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20150421 ANDA ANDA062505 Preferred Pharmaceuticals, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68788-9293_2926a6a0-0bbc-4a99-b3b5-04f3514754df 68788-9293 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium levothyroxine sodium TABLET ORAL 20150421 ANDA ANDA076187 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 100 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9294_a851ed45-38bc-499f-836b-b472f4c86ec1 68788-9294 HUMAN OTC DRUG Dendracin Neurodendraxcin Methyl Salicylate, Menthol and Capsaicin LOTION TOPICAL 20141202 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 18; 6; .015 mg/60mg; mg/60mg; mg/60mg E 20171231 68788-9295_6aab75dc-be32-48fe-923f-3c88719f9558 68788-9295 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20150422 ANDA ANDA090478 Preferred Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-9296_0aa20740-663f-4812-b2e0-c7258174617a 68788-9296 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20150421 ANDA ANDA091103 Preferred Pharmaceuticals, Inc. ESZOPICLONE 1 mg/1 CIV N 20181231 68788-9297_82b0a3ba-eb2a-4f66-b322-9273af13dc00 68788-9297 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20150421 ANDA ANDA040746 Preferred Pharmaceuticals, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 68788-9298_a717d92c-db33-4387-bffa-03430fe095c5 68788-9298 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20150421 ANDA ANDA077839 Preferred Pharmaceuticals, Inc. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 68788-9299_8b3aa7c5-5b50-4f1b-9ade-935d70cc3450 68788-9299 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20150415 ANDA ANDA202764 Preferred Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-9300_19688c75-29e0-4bd1-a99b-fb4e1313740c 68788-9300 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20150326 ANDA ANDA202800 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 68788-9301_7c456b93-7901-4ca3-8f1e-3c043b2bf3df 68788-9301 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20150323 ANDA ANDA203088 Preferred Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9302_b10492b3-2b77-484f-8a6c-5630868080e2 68788-9302 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20150326 ANDA ANDA076765 Preferred Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9305_9828cdef-f67f-4f48-a4dc-59a875cbcbca 68788-9305 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20130125 ANDA ANDA090083 Preferred Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-9306_ee08d037-4c16-4590-aaed-d7162687b8f1 68788-9306 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET ORAL 20000215 ANDA ANDA040327 Preferred Pharmaceuticals, Inc. ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-9307_279f2b40-1b85-4f45-acbf-8777e42ac7ff 68788-9307 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20150415 ANDA ANDA040804 Preferred Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68788-9308_14121f79-0e69-40db-994d-3490a49a7815 68788-9308 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20150326 ANDA ANDA076554 Preferred Pharmaceuticals, Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68788-9309_32c9dc7b-b9d1-4340-97e4-eeba1ca5c69a 68788-9309 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20150326 ANDA ANDA040362 Preferred Pharmaceuticals, Inc. PREDNISONE 20 mg/1 N 20181231 68788-9310_d37daa26-4cfc-415a-baf1-fa044fa9e6e6 68788-9310 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20150326 NDA NDA050755 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-9311_036f4e10-8292-4b0b-8cfb-ba6c879cb103 68788-9311 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065223 Preferred Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9312_f0226995-28df-453b-980c-9c2654b435a6 68788-9312 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150508 ANDA ANDA091672 Preferred Pharmaceuticals Inc OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-9313_769911cf-4f3a-47bc-96c1-ce5e6a520c0e 68788-9313 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20150325 ANDA ANDA076118 Preferred Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-9314_0dd15de1-e0a1-4eff-9970-d1e0bbb153f5 68788-9314 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20150406 ANDA ANDA077955 Preferred Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-9315_ff072709-8bd8-44b5-9ef4-4ddae873f848 68788-9315 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20150415 ANDA ANDA091113 Preferred Pharmaceuticals, Inc. ESZOPICLONE 1 mg/1 CIV N 20181231 68788-9316_40366482-66b7-4e05-b9c8-caeb016e1433 68788-9316 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20150413 ANDA ANDA065064 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-9317_bc1828b8-8fa7-4eb8-a4c3-f4d083b8b73d 68788-9317 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20150413 ANDA ANDA078895 Preferred Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68788-9318_4bb46928-a8fc-415e-8787-cf1e9e43d7d9 68788-9318 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20150415 ANDA ANDA091166 Preferred Pharmaceuticals, Inc. ESZOPICLONE 1 mg/1 CIV N 20181231 68788-9319_a18f15d0-3451-49cb-9771-030bc0967b8e 68788-9319 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20150413 ANDA ANDA065093 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 68788-9320_dcf8e993-656a-48df-aba7-c41fb1155000 68788-9320 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20150414 ANDA ANDA076320 Preferred Pharmaceuticals, Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 68788-9321_f964ef7d-d76b-406a-b6e3-1a22744f5c97 68788-9321 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine SOLUTION OPHTHALMIC 20150413 ANDA ANDA078434 Preferred Pharmaceuticals, Inc. KETOROLAC TROMETHAMINE 5 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 68788-9324_9f5af778-dd60-47a3-b643-9208e1535e04 68788-9324 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20150507 ANDA ANDA073555 Preferred Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-9325_d7130a40-3f10-4282-b00e-06ad31dbe718 68788-9325 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20150413 ANDA ANDA078428 Preferred Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-9326_ecad47b0-c831-44dc-a42a-612fcabc13be 68788-9326 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20150409 ANDA ANDA090836 Preferred Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9327_769911cf-4f3a-47bc-96c1-ce5e6a520c0e 68788-9327 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20150325 ANDA ANDA076118 Preferred Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-9328_a38b7d41-f903-4dd1-bdbb-270c376d1e2c 68788-9328 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20150402 ANDA ANDA064067 Preferred Pharmaceuticals, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9329_6c55a825-701d-44a3-92ab-fd81f9f4fcb0 68788-9329 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20150331 ANDA ANDA078152 Preferred Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68788-9330_9401abbd-412a-45c2-a535-7d957d90e906 68788-9330 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20141021 ANDA ANDA076794 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-9331_78992ad5-447b-4b69-bf5e-130218fb5be6 68788-9331 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20141020 ANDA ANDA090637 Preferred Pharmaceuticals, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 68788-9333_1db947ad-40da-4934-a66b-697be4a00ea9 68788-9333 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20140918 ANDA ANDA065166 Preferred Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9338_fc2f4fb7-f643-46bf-bfa0-7c7a8c1098d1 68788-9338 HUMAN PRESCRIPTION DRUG Voltaren diclofenac sodium GEL TOPICAL 20141008 NDA NDA022122 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 10 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9341_38adc471-393b-46c3-811d-279dcb80df97 68788-9341 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20160615 ANDA ANDA071525 Preferred Pharmaceuticals Inc. TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68788-9342_aba632da-1b5c-44ce-bf68-32453e5033c6 68788-9342 HUMAN PRESCRIPTION DRUG Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 20160809 ANDA ANDA064134 Preferred Pharmaceuticals Inc. TOBRAMYCIN; DEXAMETHASONE 3; 1 mg/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9345_3b67439a-9033-4e41-bd9d-397cb839224f 68788-9345 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine besylate TABLET ORAL 20151124 ANDA ANDA078925 Preferred Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-9360_8a4dd17f-b485-4335-a5f0-c10531613c8a 68788-9360 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20160615 ANDA ANDA075009 Preferred Pharmaceuticals Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9361_4ace51fb-dee5-4dae-89ed-1f29d38eb0cf 68788-9361 HUMAN PRESCRIPTION DRUG eszopiclone eszopiclone TABLET ORAL 20141020 ANDA ANDA091153 Preferred Pharmaceuticals, Inc. ESZOPICLONE 1 mg/1 CIV N 20181231 68788-9368_d517d5e0-ae19-4260-93c5-9017c2188806 68788-9368 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20120612 ANDA ANDA078539 Preferred Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68788-9370_94d96b16-4f53-4163-bd29-abaa91b061af 68788-9370 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140820 ANDA ANDA202045 Preferred Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9371_94d96b16-4f53-4163-bd29-abaa91b061af 68788-9371 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20140820 ANDA ANDA202045 Preferred Pharmaceuticals, Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9372_48d2d9b7-05e2-44b5-b6a5-056eb28025ab 68788-9372 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20141007 ANDA ANDA079067 Preferred Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68788-9373_25db00a4-2a65-4ba0-ab01-95922bcfce9a 68788-9373 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin, Polymyxin B Sulfates, Dexamethasone OINTMENT OPHTHALMIC 20140902 ANDA ANDA062938 Preferred Pharmaceuticals, Inc. DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1; 3.5; 10000 mg/g; mg/g; [USP'U]/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 68788-9376_57f8f399-ab53-4880-8c3a-9ae158bbd18a 68788-9376 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20141125 ANDA ANDA090200 Preferred Pharmaceuticals, Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-9378_f55af7e5-a123-4b36-9ab3-d03fd0397fb0 68788-9378 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20140728 ANDA ANDA074569 Preferred Pharmaceuticals, Inc. CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9379_f55af7e5-a123-4b36-9ab3-d03fd0397fb0 68788-9379 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20140728 ANDA ANDA074569 Preferred Pharmaceuticals, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9380_9c6ad60b-3cb3-4a62-bad1-9c7e29f4c94a 68788-9380 HUMAN PRESCRIPTION DRUG cilostazol cilostazol TABLET ORAL 20140728 ANDA ANDA077030 Preferred Pharmaceuticals, Inc. CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20181231 68788-9381_6be055fa-93da-4295-9339-499b5e738df6 68788-9381 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140730 ANDA ANDA073085 Preferred Pharmaceuticals, Inc. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9385_1ea241be-50cb-40f4-b3bf-9d4ab48e66f1 68788-9385 HUMAN PRESCRIPTION DRUG promethazine hydrochloride and codeine phosphate promethazine hydrochloride and codeine phosphate SYRUP ORAL 20140722 ANDA ANDA090180 Preferred Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 68788-9386_f59cb514-6c1a-4131-a628-ddfdaf6c4682 68788-9386 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20140723 ANDA ANDA201507 Preferred Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68788-9387_0b09e8d5-e8e3-4dd3-84ff-62cde05a8b92 68788-9387 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20141013 NDA NDA021342 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9388_ca164f44-1fd0-4000-8839-2b6db9be7c67 68788-9388 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20141118 ANDA ANDA086989 Preferred Pharmaceuticals, Inc. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-9389_16c7f0e5-f638-4d5f-91b2-000b4dc2ebf2 68788-9389 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140717 NDA AUTHORIZED GENERIC NDA020254 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9390_c8a88bc0-7b98-4772-87e7-3336df20bc56 68788-9390 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Preferred Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-9391_2c6a4a2a-ea02-4b92-b478-6521d0a6e05f 68788-9391 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20140703 ANDA ANDA077689 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-9392_5d34ffc2-1239-41ce-bae6-e2abc084b2ee 68788-9392 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20140703 ANDA ANDA077691 Preferred Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9393_c76b595b-ba58-4bea-98fe-955e0f76f0aa 68788-9393 HUMAN PRESCRIPTION DRUG erythromycin erythromycin OINTMENT OPHTHALMIC 20140703 ANDA ANDA062447 Preferred Pharmaceuticals, Inc. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9394_b29b2665-2f7e-4daa-91cb-70ff4d95ed1f 68788-9394 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET ORAL 20140624 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 68788-9397_48d2d9b7-05e2-44b5-b6a5-056eb28025ab 68788-9397 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20131216 ANDA ANDA079067 Preferred Pharmaceuticals, Inc. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68788-9399_9ce8caa0-cc7b-431e-a2f4-e4323ece18e4 68788-9399 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20140616 OTC MONOGRAPH NOT FINAL part343 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 68788-9400_56c0a575-6fd4-4613-bcef-95edbaec0a68 68788-9400 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20140616 ANDA ANDA076942 Preferred Pharmaceuticals, Inc. KETOCONAZOLE 20.5 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-9401_b34f649a-88e9-495a-a26a-b2cf528699d5 68788-9401 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20140616 ANDA ANDA040807 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-9402_d517d5e0-ae19-4260-93c5-9017c2188806 68788-9402 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20120612 ANDA ANDA078539 Preferred Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68788-9403_34139adb-ed49-4a6f-9b58-7f1990ceeac6 68788-9403 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20140617 ANDA ANDA040779 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 68788-9404_804a87a8-7ae1-444d-8e48-0bd3828cc568 68788-9404 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20140528 ANDA ANDA065253 Preferred Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9405_6c634cc1-8230-4253-9ec8-bd92fdd9790c 68788-9405 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20141103 ANDA ANDA080937 Preferred Pharmaceuticals, Inc. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20191231 68788-9406_88bf3d27-5628-42d2-8dee-b08b9710206d 68788-9406 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20140523 ANDA ANDA201921 Preferred Pharmaceuticals, Inc. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68788-9407_919bec77-b9ab-4ad2-be07-88cbe6a6a2c7 68788-9407 HUMAN OTC DRUG SENEXON-S DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20140521 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals, Inc. DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 N 20181231 68788-9410_48a638db-f8fd-4843-bb79-a45cf12eeae2 68788-9410 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20150818 ANDA ANDA076004 Preferred Pharmaceuticals Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9411_425fc948-1da1-4590-9b39-f7f47e9da4bc 68788-9411 HUMAN PRESCRIPTION DRUG LISINOPRIL LISINOPRIL TABLET ORAL 20130502 ANDA ANDA203508 Preferred Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9412_f73ec7ab-7d75-4bd9-b1bb-7225a0ccaab8 68788-9412 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140602 ANDA ANDA075492 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9414_48a22f5c-0a7d-4d53-8728-b10a9fe7e0db 68788-9414 HUMAN PRESCRIPTION DRUG PROCHLORPERAZINE MALEATE Prochlorperazine maleate TABLET ORAL 20140513 ANDA ANDA040268 Preferred Pharmaceuticals, Inc. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68788-9415_aaee8cb2-f935-41b1-99fe-8d3124dfcce5 68788-9415 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate and hydrocortisone SUSPENSION AURICULAR (OTIC) 20140513 ANDA ANDA062488 Preferred Pharmaceuticals, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9416_4f3b06ca-fa8f-4e26-92b9-a833f0fac796 68788-9416 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20141204 ANDA ANDA040114 Preferred Pharmaceuticals, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68788-9418_10975dd6-514a-4ce9-8744-5d6c88af39c3 68788-9418 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20140507 ANDA ANDA077927 Preferred Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 68788-9419_c5bf4dea-4d41-4ab4-8244-25920e740dec 68788-9419 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68788-9421_079e901f-48d2-4983-8ea6-53ffecb8d8b2 68788-9421 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20140508 ANDA ANDA090931 Preferred Pharmaceuticals, Inc. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68788-9423_b9ff3f9d-c0ae-4275-9a9f-8fd70272c001 68788-9423 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride ER Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20140429 ANDA ANDA091680 Preferred Pharmaceuticals, Inc. DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68788-9424_a18f15d0-3451-49cb-9771-030bc0967b8e 68788-9424 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20141113 ANDA ANDA065098 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 68788-9426_040398fe-ec5c-4c7c-9636-3195aafb84da 68788-9426 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20140421 ANDA ANDA074356 Preferred Pharmaceuticals, Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 68788-9429_148bb96a-d96f-42fc-a89f-55cacccbab57 68788-9429 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20141021 ANDA ANDA078155 Preferred Pharmaceuticals, Inc. SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9430_ede65905-ef80-4520-b15a-6d640fb7968b 68788-9430 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151019 ANDA ANDA074174 Preferred Pharmaceuticals Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9432_99d6884d-afd4-4213-86ab-933ad783cee1 68788-9432 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride Valacyclovir Hydrochloride TABLET ORAL 20140912 ANDA ANDA077478 Preferred Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68788-9433_cfcdbec6-ca15-4eeb-87d2-b10adcb49969 68788-9433 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20111220 ANDA ANDA201090 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-9437_f335618b-915c-47a6-ad0e-0bdeb1216ea1 68788-9437 HUMAN PRESCRIPTION DRUG Levothyroxine Sodium Levothyroxine Sodium TABLET ORAL 20161102 NDA NDA021210 Preferred Pharmaceuticals, Inc. LEVOTHYROXINE SODIUM .137 mg/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 68788-9438_fc5d126f-75b0-4871-9f52-20066003d8d5 68788-9438 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20160617 ANDA ANDA202717 Preferred Pharmaceuticals Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68788-9439_e486a9da-5021-47e9-ae8d-bb0f76655a0d 68788-9439 HUMAN PRESCRIPTION DRUG Montelukast Sodium montelukast sodium TABLET, CHEWABLE ORAL 20140505 ANDA ANDA091588 Preferred Pharmaceuticals, Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 68788-9456_606f3ed8-d8b5-47cc-8f7e-c736516c7412 68788-9456 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20140925 ANDA ANDA090432 Preferred Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9461_5f6cae21-74a4-47a6-8bf4-ad605aeb6f5a 68788-9461 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20160614 ANDA ANDA078245 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-9463_c9030d0f-731b-4eeb-a89d-8d5fb9881504 68788-9463 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20140521 ANDA ANDA077982 Preferred Pharmaceuticals, Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 68788-9466_2c649094-519d-4e0c-aa62-61dc7da17dca 68788-9466 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydroxyzine Hydrochloride SOLUTION ORAL 20150821 ANDA ANDA201674 Preferred Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68788-9479_6ec29c49-ad66-4467-8f3f-549103372044 68788-9479 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20140414 ANDA ANDA040625 Preferred Pharmaceuticals, Inc. FOLIC ACID 1 mg/1 N 20181231 68788-9481_9249a911-b8a9-460e-bede-453ede9a431c 68788-9481 HUMAN OTC DRUG ED A-HIST CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE TABLET, COATED ORAL 20140401 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 4; 10 mg/1; mg/1 N 20181231 68788-9486_115b8364-d5a6-431e-8297-39478ab48caa 68788-9486 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20150105 ANDA ANDA202764 Preferred Pharmaceuticals, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-9487_5e1841eb-81c2-47a5-97f5-e5888f9e1e60 68788-9487 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20140423 ANDA ANDA202152 Preferred Pharmaceuticals, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 68788-9488_6b5d9180-ea2f-4bb7-9e88-b596b638cb1d 68788-9488 HUMAN OTC DRUG Double Antibiotic Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20140520 OTC MONOGRAPH FINAL part333B Preferred Pharmaceuticals, Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g E 20171231 68788-9490_1f8c9110-07e4-4d39-81f6-8c3dc5600f28 68788-9490 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20140331 ANDA ANDA201504 Preferred Pharmaceuticals, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 68788-9492_d9f97fcd-1084-4f87-b114-11f72b6f7f24 68788-9492 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20140402 ANDA ANDA077272 Preferred Pharmaceuticals, Inc. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 68788-9493_43a86804-1764-42b6-9f73-78ba17b2e506 68788-9493 HUMAN PRESCRIPTION DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20140402 ANDA ANDA078488 Preferred Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 68788-9494_46452b1f-ffe3-4298-a1d2-eee4df46d9f2 68788-9494 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20140402 ANDA ANDA071251 Preferred Pharmaceuticals, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 68788-9495_4fe86bde-3683-47b3-897c-e55a1256ec31 68788-9495 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20140402 ANDA ANDA077856 Preferred Pharmaceuticals, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9496_1402d6fc-73e9-4702-a2e3-71485d37122f 68788-9496 HUMAN OTC DRUG Terocin Methyl Salicylate, Capsaicin, Menthol and Lidocaine Hydrochloride LOTION TOPICAL 20140320 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. METHYL SALICYLATE; CAPSAICIN; MENTHOL; LIDOCAINE HYDROCHLORIDE 25; .025; 10; 2.5 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 68788-9497_2a02e2ad-d869-497b-b809-fb4042b9b173 68788-9497 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20140326 ANDA ANDA076533 Preferred Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68788-9499_877f08d1-4559-4834-b860-1f55ec998c45 68788-9499 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20140314 ANDA ANDA090278 Preferred Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-9500_17ff16e2-2b58-4bad-b64e-01047e527688 68788-9500 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20140305 ANDA ANDA076817 Preferred Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68788-9501_e6490bcd-a712-49f3-b5d6-adf1326d620c 68788-9501 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20131203 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 68788-9502_14fced4e-55e1-4f97-a9a7-74dcd49e113e 68788-9502 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20140801 ANDA ANDA040749 Preferred Pharmaceuticals, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68788-9503_8f055247-c404-49b7-bdd6-027c0861ffd3 68788-9503 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20130619 ANDA ANDA085161 Preferred Pharmaceuticals, Inc. PREDNISONE 20 mg/1 N 20181231 68788-9504_cd676c76-04cd-4c71-a1fa-506a6232005a 68788-9504 HUMAN PRESCRIPTION DRUG Ofloxacin Otic Ofloxacin SOLUTION AURICULAR (OTIC) 20140221 ANDA ANDA076527 Preferred Pharmaceuticals, Inc. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-9505_b0a133e1-4ee4-4be5-86a4-061a422940b5 68788-9505 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20140227 ANDA ANDA070035 Preferred Pharmaceuticals, Inc. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 68788-9506_e2a5b618-d4a4-46a3-99e7-6c9bb7fffcb1 68788-9506 HUMAN PRESCRIPTION DRUG ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate TABLET ORAL 20140225 ANDA ANDA040419 Preferred Pharmaceuticals, Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 68788-9508_5dac8b8a-6618-4dd4-8c25-d402239cf3bd 68788-9508 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140226 ANDA ANDA078048 Preferred Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-9509_ca054ca7-b88f-4d99-be33-2db4286f8ce9 68788-9509 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140228 ANDA ANDA090858 Preferred Pharmaceuticals, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-9510_1b4b8d3f-1386-408e-bfa2-c953fac95b9b 68788-9510 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20140218 ANDA ANDA202038 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68788-9511_2262375a-a3f5-43d7-851d-f8da50587986 68788-9511 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20140205 ANDA ANDA078203 Preferred Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 68788-9512_096a1f58-186d-4e6d-8ba4-62d837a0b7fc 68788-9512 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim SUSPENSION ORAL 20140212 ANDA ANDA091348 Preferred Pharmaceuticals, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 200; 40 mg/5mL; mg/5mL Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68788-9513_7d0f4abc-21ae-4d5c-918f-adee3b5d5052 68788-9513 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140303 ANDA ANDA083677 Preferred Pharmaceuticals, Inc. PREDNISONE 20 mg/1 N 20181231 68788-9514_2a02e2ad-d869-497b-b809-fb4042b9b173 68788-9514 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20140305 ANDA ANDA076533 Preferred Pharmaceuticals, Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68788-9516_e64af0c0-72b8-48a9-8c89-7d9557340d6d 68788-9516 HUMAN PRESCRIPTION DRUG Nystatin Nystatin OINTMENT TOPICAL 20140210 ANDA ANDA062472 Preferred Pharmaceuticals, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 68788-9517_c62c55af-c70f-4342-a4f1-fd816b87c056 68788-9517 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20130206 ANDA ANDA076436 Preferred Pharmaceuticals, Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68788-9518_acc3a188-26c0-4ecf-a120-8490590f3d94 68788-9518 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate OINTMENT TOPICAL 20140305 ANDA ANDA074407 Preferred Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9519_68bd4fd6-9452-4f7e-863a-7d187c20e1f5 68788-9519 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20140206 ANDA ANDA090061 Preferred Pharmaceuticals, Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 68788-9521_7326c97b-56f6-4688-9c7b-75513c3a838c 68788-9521 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140206 ANDA ANDA065509 Preferred Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9522_85b90ae5-5405-4cf3-8b05-398ebf16a61c 68788-9522 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride hydroxyzine hydrochloride SOLUTION ORAL 20140206 ANDA ANDA040010 Preferred Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68788-9523_8f02f691-09f5-4ae6-a08d-df33577968a5 68788-9523 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140203 ANDA ANDA076201 Preferred Pharmaceuticals, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9524_c83befb5-6cf9-4b01-ba3a-c1a7729975be 68788-9524 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140127 ANDA ANDA077284 Preferred Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68788-9525_f629f088-8c4b-46cf-be8b-6026fce2ec06 68788-9525 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20140221 ANDA ANDA085223 Preferred Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68788-9526_61de9508-6434-4719-abc1-b877dbcc083e 68788-9526 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20140120 ANDA ANDA079132 Preferred Pharmaceuticals, Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 68788-9527_74b37e29-bba3-4758-bc54-e4f2649aef8b 68788-9527 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131203 ANDA ANDA075743 Preferred Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9529_7326c97b-56f6-4688-9c7b-75513c3a838c 68788-9529 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20140206 ANDA ANDA065507 Preferred Pharmaceuticals, Inc. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9530_caf122e6-f64f-4fc4-aaa1-e8d1dc4ca5b8 68788-9530 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20131220 ANDA ANDA078720 Preferred Pharmaceuticals, Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 68788-9532_7903219b-176e-46f3-994d-e7c5163bcebe 68788-9532 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20131218 ANDA ANDA090278 Preferred Pharmacetucals, Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-9533_7903219b-176e-46f3-994d-e7c5163bcebe 68788-9533 HUMAN PRESCRIPTION DRUG TOPIRAMATE TOPIRAMATE TABLET, FILM COATED ORAL 20131218 ANDA ANDA090278 Preferred Pharmacetucals, Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-9534_92f8a6fa-8d6f-4851-b3b3-e4b3aaaf39dd 68788-9534 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20140825 ANDA ANDA202248 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68788-9535_a7cef682-4d7b-4e23-afd6-639a30cdd04d 68788-9535 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride clonidine hydrochloride TABLET ORAL 20141022 ANDA ANDA077901 Preferred Pharmaceuticals, Inc. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 68788-9536_74b37e29-bba3-4758-bc54-e4f2649aef8b 68788-9536 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Preferred Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9537_e6490bcd-a712-49f3-b5d6-adf1326d620c 68788-9537 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20131203 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 68788-9538_475acbc5-d54d-48fb-a0d0-18888d6f8033 68788-9538 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20131203 ANDA ANDA062703 Preferred Pharmaceuticals, Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9539_475acbc5-d54d-48fb-a0d0-18888d6f8033 68788-9539 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin POWDER, FOR SUSPENSION ORAL 20131203 ANDA ANDA062703 Preferred Pharmaceuticals, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9541_a7d9c955-cc7a-4c0f-9282-808ba46a8a15 68788-9541 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide PASTE TOPICAL 20170508 ANDA ANDA040771 Preferred Pharmaceuticals, Inc. TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9545_0de4a929-2d50-42a7-9492-e70bc58ffab8 68788-9545 HUMAN PRESCRIPTION DRUG PrednisoLONE Prednisolone SYRUP ORAL 20131025 ANDA ANDA040775 Preferred Pharmaceuticals, Inc. PREDNISOLONE 15 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9546_49d6d4b6-456f-4e45-b348-1358fc2af58d 68788-9546 HUMAN PRESCRIPTION DRUG Chlorhexidine Gluconate Chlorhexidine Gluconate RINSE ORAL 20131022 ANDA ANDA077789 Preferred Pharmaceuticals, Inc. CHLORHEXIDINE GLUCONATE 1.2 mg/mL Decreased Cell Wall Integrity [PE] N 20181231 68788-9547_74516c1d-5346-4d8d-bac1-8746cd44c749 68788-9547 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20131024 ANDA ANDA078327 Preferred Pharmaceuticals, Inc. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68788-9548_fc6d4397-d084-4c12-b69a-edf72686e1d0 68788-9548 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20131114 ANDA ANDA201043 Preferred Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 68788-9549_c7449c29-5cfa-4852-ab03-c6f06932b682 68788-9549 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20131230 ANDA ANDA075786 Preferred Pharmaceuticals, Inc. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68788-9550_d8baa7a9-f647-48a1-8c09-51bc7a3a26ba 68788-9550 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20131022 ANDA ANDA202477 Preferred Pharmaceuuticals, Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68788-9551_e938163b-2352-4a87-b9c3-9c11fc30d368 68788-9551 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20140423 ANDA ANDA040256 Preferred Pharmaceuticals, Inc. PREDNISONE 5 mg/1 N 20181231 68788-9552_9611c1da-60f8-4e82-ba93-a31a56204db4 68788-9552 HUMAN PRESCRIPTION DRUG VENTOLIN HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20131010 NDA NDA020983 Preferred Pharmaceuticals, Inc. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68788-9553_d2dcdc89-11a5-4251-8fef-b74bd6fafdd0 68788-9553 HUMAN OTC DRUG Berri-Freez MENTHOL GEL TOPICAL 20131007 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. MENTHOL, UNSPECIFIED FORM 4.5 g/100g N 20181231 68788-9554_544f9814-0cf5-40d4-ab99-e28ac9a6d325 68788-9554 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED ORAL 20131003 ANDA ANDA090216 Preferred Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68788-9555_75dbff74-4b03-4e63-a857-f3d304d0656f 68788-9555 HUMAN OTC DRUG Terocin Lidocaine, Menthol PATCH TOPICAL 20130923 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. LIDOCAINE; MENTHOL, UNSPECIFIED FORM 600; 600 mg/1; mg/1 N 20181231 68788-9556_0b1874b7-9002-4ca9-b136-df08b8cb4d40 68788-9556 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130415 ANDA ANDA090548 Preferred Pharmaceuticals, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9557_847aa65f-542a-4a30-84e9-9a0b4d76c12d 68788-9557 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20131118 ANDA ANDA091231 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 68788-9558_373f4f27-e048-45dd-9386-3a71f157b905 68788-9558 HUMAN OTC DRUG Natural Fiber Therapy Natural Laxative Psyllium Husk POWDER, FOR SOLUTION ORAL 20131114 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals, Inc. PSYLLIUM HUSK 3.4 g/7g N 20181231 68788-9559_7ad0e5d5-ae13-4c0a-a32f-d637bbb2628d 68788-9559 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20130827 ANDA ANDA090469 Preferred Pharmaceuticals, Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68788-9660_37b0cad6-26cc-435e-909f-c4b2af435981 68788-9660 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20130822 ANDA ANDA090901 Preferred Pharmaceuticals, Inc. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 68788-9661_74b37e29-bba3-4758-bc54-e4f2649aef8b 68788-9661 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20131203 ANDA ANDA075743 Preferred Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9662_a6ef7b12-14a2-42c9-aba2-627f9be132be 68788-9662 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 20130816 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9665_624827d6-dbf8-4f3d-a8c0-c92474cad7de 68788-9665 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 20130805 ANDA ANDA072641 Preferred Pharmaceuticals, Inc. CLOTRIMAZOLE 1 g/100g E 20171231 68788-9667_bb0d4a5c-3f67-4257-9937-94f4131dcc6d 68788-9667 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130729 ANDA ANDA075991 Preferred Pharmaceuticals, Inc. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9668_bb0d4a5c-3f67-4257-9937-94f4131dcc6d 68788-9668 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20130729 ANDA ANDA075991 Preferred Pharmaceuticals, Inc. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9669_fa8ce543-9320-473d-af59-726c727e47b6 68788-9669 HUMAN PRESCRIPTION DRUG Bupropion hydrochloride Bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130725 ANDA ANDA078866 Preferred Pharmaceuticals, Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68788-9670_91e445f6-c532-4191-ae05-c270115c2f1d 68788-9670 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20130724 ANDA ANDA090469 Preferred Pharmaceuticals, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 68788-9671_6d4e4f9e-4164-4b37-82bc-a199b581a132 68788-9671 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20130606 OTC MONOGRAPH FINAL part343 Preferred Pharmaceuticals, Inc. ASPIRIN 81 mg/1 N 20181231 68788-9672_77a4b67e-b5f6-4eea-8ad4-f11946d6fe65 68788-9672 HUMAN OTC DRUG LenzaGel LIDOCAINE HYDROCHLORIDE, MENTHOL GEL TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM 4; 1 g/100g; g/100g N 20181231 68788-9673_3ee028dd-e6c0-490b-baa8-8eeba48ab88c 68788-9673 HUMAN PRESCRIPTION DRUG Terazosin Terazosin CAPSULE ORAL 20130712 ANDA ANDA075498 Preferred Pharmaceuticals, Inc. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68788-9675_607214d5-9bc6-499c-82db-118c1f518698 68788-9675 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20130624 ANDA ANDA075580 Preferred Pharmaceuticals, Inc. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68788-9676_756fd8a9-5683-4477-aa9b-30606eba3298 68788-9676 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20130515 NDA NDA021134 Preferred Pharmaceuticals, Inc. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 68788-9677_f45eaa26-6c7f-4405-be7d-ac43f488b135 68788-9677 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130604 ANDA ANDA077255 Preferred Pharmaceuticals, Inc. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 68788-9678_c906a394-da8e-4a03-98cd-0b9793099a4a 68788-9678 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20130422 ANDA ANDA077538 Preferred Pharmaceuticals, Inc. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9679_99a7c4d3-39f9-4e6e-80d0-250c695f6fa3 68788-9679 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20130424 ANDA ANDA040863 Preferred Pharmaceuticals, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68788-9680_6eead064-1e84-4b1e-84d6-b417e6c1e5e7 68788-9680 HUMAN PRESCRIPTION DRUG Naphazoline Naphazoline Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20130422 ANDA ANDA083590 Preferred Pharmaceuticals, Inc. NAPHAZOLINE HYDROCHLORIDE 1 mg/mL N 20181231 68788-9681_0b1874b7-9002-4ca9-b136-df08b8cb4d40 68788-9681 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130415 ANDA ANDA090548 Preferred Pharmaceuticals, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9682_fc0153ec-96f7-4cbf-9614-3da04dc15c0b 68788-9682 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20130422 ANDA ANDA090871 Preferred Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9683_0b1874b7-9002-4ca9-b136-df08b8cb4d40 68788-9683 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20130415 ANDA ANDA090548 Preferred Pharmaceuticals, Inc. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9684_1fba1b96-7240-4ec8-9e8e-1da85ca482c0 68788-9684 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET ORAL 20130423 ANDA ANDA078536 Preferred Pharmaceuticals, Inc. CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 68788-9685_620e6f70-6bed-4d64-835f-b26672ece9ad 68788-9685 HUMAN OTC DRUG Senna-Lax Sennosides TABLET ORAL 20130328 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals, Inc. SENNOSIDES A AND B 8.6 mg/1 E 20171231 68788-9686_082bb1d7-95b1-41ab-81f0-3ea6d76f2bae 68788-9686 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20130401 ANDA ANDA078459 Preferred Pharmaceuticals, Inc. METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-9687_1047e45b-2456-45b3-af10-4e8f5e453003 68788-9687 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20130327 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68788-9688_1047e45b-2456-45b3-af10-4e8f5e453003 68788-9688 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 68788-9690_5337364e-bd0c-4747-9ad2-244c80a2aace 68788-9690 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20130326 ANDA ANDA075090 Preferred Pharmaceuticals, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 68788-9691_abf5f242-eaae-4253-b16c-365c2cef9bac 68788-9691 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130327 ANDA ANDA078332 Preferred Pharmaceuticals, Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68788-9692_4db7f9f4-f5df-4a75-a6a6-04a2b76a30aa 68788-9692 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20130326 ANDA ANDA078216 Preferred Pharmaceuticals, Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9693_e08aebc9-cb88-4e7a-a83d-5d17eb72be50 68788-9693 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20130325 ANDA ANDA077397 Preferred Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 68788-9694_0a556f1b-c11f-4a35-8a13-5a836cbad155 68788-9694 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20130326 ANDA ANDA075356 Preferred Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9695_90d34431-052d-4bc3-a905-2f5f10653280 68788-9695 HUMAN PRESCRIPTION DRUG LEVOFLOXACIN LEVOFLOXACIN TABLET ORAL 20130327 ANDA ANDA090722 Preferred Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 68788-9696_5293b7cc-eaf4-4bb2-9487-a8e8100204b5 68788-9696 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20130422 ANDA ANDA088496 Preferred Pharmaceuticals, Inc. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68788-9697_1c418c78-6e15-496e-8ba9-49a78d5f034e 68788-9697 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20130319 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68788-9698_1c418c78-6e15-496e-8ba9-49a78d5f034e 68788-9698 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20130319 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 68788-9699_fc480882-052b-4800-89cc-720125e1794a 68788-9699 HUMAN PRESCRIPTION DRUG Hydroquinone Hydroquinone CREAM TOPICAL 20130318 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc. HYDROQUINONE 40 mg/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 68788-9700_af354948-0216-46b0-8890-2ed00294352d 68788-9700 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20130315 ANDA ANDA065135 Preferred Pharmaceuticals, Inc. CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9701_af354948-0216-46b0-8890-2ed00294352d 68788-9701 HUMAN PRESCRIPTION DRUG cefuroxime axetil cefuroxime axetil TABLET ORAL 20130315 ANDA ANDA065135 Preferred Pharmaceuticals, Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9702_4cf9a7a5-0e3a-430f-b68b-d0338d2672c2 68788-9702 HUMAN PRESCRIPTION DRUG Neomycin Polymyxin B Sulfates and Dexamethasone Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone SUSPENSION/ DROPS OPHTHALMIC 20130314 ANDA ANDA064135 Preferred Pharmaceuticals, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE 3.5; 10000; 1 mg/mL; [USP'U]/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 68788-9703_f1f70a31-8e98-4121-86e3-7e2a16e6fac9 68788-9703 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20130308 ANDA ANDA065442 Preferred Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68788-9704_2dc11a40-735d-451a-9ee1-1d59e864924e 68788-9704 HUMAN OTC DRUG loperamide hydrochloride loperamide HCl LIQUID ORAL 20130308 ANDA ANDA091292 Preferred Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 68788-9705_7858c5a8-3e73-4596-9744-70cde63dce3c 68788-9705 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20130218 ANDA ANDA085082 Preferred Pharmaceuticals, Inc. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68788-9706_79fb7461-36ac-445a-93eb-721d99f78fa9 68788-9706 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20130206 ANDA ANDA071250 Preferred Pharmaceuticals, Inc. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 68788-9707_3da3bf52-fb61-4073-9bbd-5e95a7662bbd 68788-9707 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20110812 ANDA ANDA201043 Preferred Pharmaceuticals, Inc. LEVOFLOXACIN 500 mg/1 N 20181231 68788-9708_fd0d6842-5a40-481d-af46-2cc813415b7f 68788-9708 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 20130205 ANDA ANDA075319 Preferred Pharmaceuticals, Inc. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-9709_0fab21c7-b2d2-47e7-aea4-a848a5f1ab28 68788-9709 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20130204 ANDA ANDA090367 Preferred Pharmaceuticals, Inc. LEVOFLOXACIN 750 mg/1 N 20181231 68788-9710_de86fdbe-113a-4856-8cd0-149fb5e142d8 68788-9710 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20130130 ANDA ANDA065271 Preferred Pharmaceuticals, Inc. AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9711_41455d4c-be76-4843-906b-37a9fafac459 68788-9711 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 20130130 ANDA ANDA089175 Preferred Pharmaceuticals, Inc. BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 68788-9712_9828cdef-f67f-4f48-a4dc-59a875cbcbca 68788-9712 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20130125 ANDA ANDA090083 Preferred Pharmaceuticals, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-9713_ecad47b0-c831-44dc-a42a-612fcabc13be 68788-9713 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20130205 ANDA ANDA090836 Preferred Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9714_c59408a1-bc16-4f64-8d19-5189c583785c 68788-9714 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram Oxalate TABLET, FILM COATED ORAL 20130118 ANDA ANDA090432 Preferred Pharmaceuticals, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9715_8ed47903-ab1f-41fa-9264-4565e4e7f80a 68788-9715 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20130114 ANDA ANDA088799 Preferred Pharmaceuticals, Inc HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9716_df30a17e-7091-4c32-a21e-ee0d2400aca4 68788-9716 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20130110 ANDA ANDA077870 Preferred Pharmaceuticals, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-9718_b3d2349a-9bb1-4bbe-8ad1-3da3ff513021 68788-9718 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20121220 ANDA ANDA078406 Preferred Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9719_b3d2349a-9bb1-4bbe-8ad1-3da3ff513021 68788-9719 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20121220 ANDA ANDA078406 Preferred Pharmaceuticals, Inc. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 68788-9721_af823d5b-73ab-4c5e-924e-f1b2fe7cbecb 68788-9721 HUMAN PRESCRIPTION DRUG CAPTOPRIL captopril TABLET ORAL 20121213 ANDA ANDA074532 Preferred Pharmaceuticals, Inc. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9723_de6597b5-e0c8-4f9c-a724-371f1efee47e 68788-9723 HUMAN OTC DRUG Meclizine HCl Meclizine HCl TABLET ORAL 20121213 OTC MONOGRAPH FINAL part336 Preferred Pharmaceuticals, Inc. MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 68788-9724_b71fe02d-a9bd-49c7-8b02-5f898e958f22 68788-9724 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED ORAL 20121121 ANDA ANDA077859 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-9725_1fc07652-ad0a-4e38-9ff1-3f9b2c998a2c 68788-9725 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20121119 ANDA ANDA091569 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-9726_1fc07652-ad0a-4e38-9ff1-3f9b2c998a2c 68788-9726 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20121119 ANDA ANDA091568 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-9727_0ea06efc-c973-44fb-be1e-bdbf0c3a58fd 68788-9727 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET, EXTENDED RELEASE ORAL 20121115 ANDA ANDA078387 Preferred Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9728_df30a17e-7091-4c32-a21e-ee0d2400aca4 68788-9728 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20121114 ANDA ANDA077870 Preferred Pharmaceuticals, Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-9729_d2d5a2bf-f46b-4f5c-92f7-b292d1c842a9 68788-9729 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20121031 ANDA ANDA091426 Preferred Pharmaceuticals, Inc. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 68788-9730_8c1cfa0d-1c88-4e97-af52-7d5cd989276f 68788-9730 HUMAN PRESCRIPTION DRUG TOPIRAMATE topiramate TABLET ORAL 20121031 ANDA ANDA079153 Preferred Pharmaceuticals, Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-9731_af823d5b-73ab-4c5e-924e-f1b2fe7cbecb 68788-9731 HUMAN PRESCRIPTION DRUG CAPTOPRIL captopril TABLET ORAL 20121213 ANDA ANDA074532 Preferred Pharmaceuticals, Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9732_fb118a8e-dd19-47be-acd1-4f343442306b 68788-9732 HUMAN PRESCRIPTION DRUG Gentak Gentamicin Sulfate OINTMENT OPHTHALMIC 20121023 ANDA ANDA064093 Preferred Pharmaceuticals, Inc. GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 68788-9733_4bf2d51d-2944-4450-a817-1baec6a909ef 68788-9733 HUMAN PRESCRIPTION DRUG PREDNISOLONE ACETATE prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 20121023 NDA AUTHORIZED GENERIC NDA017011 Preferred Pharmaceuticals, Inc. PREDNISOLONE ACETATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68788-9734_4996221e-e0a8-4745-8bc9-44b5507a1b46 68788-9734 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride SOLUTION ORAL 20121022 ANDA ANDA090182 Preferred Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL N 20181231 68788-9735_442adf75-bd58-4a80-8bed-5da0eb431386 68788-9735 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20120430 ANDA ANDA077068 Preferred Pharmaceuticals, Inc. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68788-9736_e8aca970-a4f9-46c6-8a2f-d6acf12f7dfe 68788-9736 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20150820 ANDA ANDA088629 Preferred Pharmaceuticals Inc. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 68788-9737_4da3a37b-5da1-4043-987c-03cec00980db 68788-9737 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20121008 ANDA ANDA040786 Preferred Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68788-9738_abf5f242-eaae-4253-b16c-365c2cef9bac 68788-9738 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20130327 ANDA ANDA078332 Preferred Pharmaceuticals, Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68788-9739_4786793b-f97c-4f19-8f85-2e6adb2523c2 68788-9739 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120928 ANDA ANDA090796 Preferred Pharmaceuticals, Inc. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9740_4786793b-f97c-4f19-8f85-2e6adb2523c2 68788-9740 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120928 ANDA ANDA090796 Preferred Pharmaceuticals, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9741_4786793b-f97c-4f19-8f85-2e6adb2523c2 68788-9741 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20120928 ANDA ANDA090796 Preferred Pharmaceuticals, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9742_8109dc20-fb1b-4a0b-961a-3c77efe9f16f 68788-9742 HUMAN PRESCRIPTION DRUG PENTOXIFYLLINE PENTOXIFYLLINE TABLET, EXTENDED RELEASE ORAL 20120928 ANDA ANDA075191 Preferred Pharmaceuticals, Inc. PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] N 20181231 68788-9743_0f1fe5bb-e313-4d46-8543-bb95046cf2d2 68788-9743 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 19970819 ANDA ANDA085588 Preferred Pharmaceuticals, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 68788-9744_d46f1cc4-a73d-427a-aa20-1790f4c27e84 68788-9744 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040886 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68788-9745_9f858cef-1021-479a-a881-03872df0aa27 68788-9745 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20120925 NDA NDA050725 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 400; 57 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-9747_148bb96a-d96f-42fc-a89f-55cacccbab57 68788-9747 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20120228 ANDA ANDA078155 Preferred Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9748_0f2cb793-ff1f-40fc-9870-c225ff30a397 68788-9748 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20120110 ANDA ANDA076048 Preferred Pharmaceuticals, Inc. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-9749_c853d873-5c5d-44ee-b0d2-41a30bcd8210 68788-9749 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20120305 ANDA ANDA074132 Preferred Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-9750_51361137-7515-4bd1-934d-04c1c5e4cf89 68788-9750 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120130 ANDA ANDA076063 Preferred Pharmaceuticals, Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9752_a35fc563-9bf1-4242-92f8-638c6827eba1 68788-9752 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20100621 ANDA ANDA062791 Preferred Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 68788-9756_be6ae42c-6db7-4fb5-8cb5-eb84ff133504 68788-9756 HUMAN OTC DRUG GERI-LANTA ANTACID ANTIGAS aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20120727 OTC MONOGRAPH FINAL part331 Preferred Pharmaceuticals, Inc. ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 68788-9757_42ce2490-a59c-423d-8250-b56914d5f017 68788-9757 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20150820 ANDA ANDA077662 Preferred Pharmaceuticals Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-9760_c16f58f1-38ec-4284-9e84-21af179eac91 68788-9760 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20150820 ANDA ANDA065418 Preferred Pharmaceuticals Inc. CEFDINIR MONOHYDRATE 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9761_54a0153e-9c72-400a-8025-868ed6da09ac 68788-9761 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20150820 ANDA ANDA073026 Preferred Pharmaceutials Inc. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-9762_478f3aa0-a733-49c0-b7a9-4d2e6da2253b 68788-9762 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20150819 ANDA ANDA091179 Preferred Pharmaceuticals Inc. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68788-9763_93b6690c-f56a-4f50-bdc5-189df5e12d56 68788-9763 HUMAN PRESCRIPTION DRUG Rizatriptan Rizatriptan TABLET, FILM COATED ORAL 20150818 ANDA ANDA203147 Preferred Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68788-9764_443f0c64-8b63-44dc-a894-d9a3500039be 68788-9764 HUMAN PRESCRIPTION DRUG Proctozone HC hydrocortisone CREAM TOPICAL 20120821 ANDA ANDA089682 Preferred Pharmaceuticals, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9765_2f971bd9-180f-42bf-ad2e-b19c47cbb1e4 68788-9765 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150820 ANDA ANDA075994 Preferred Pharmaceuticals Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9766_d1368f3f-4c17-48cd-9b80-f86a6ef81c06 68788-9766 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20150819 ANDA ANDA078888 Preferred Pharmaceuticals Inc. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 68788-9767_ec2ec60e-0d46-476f-8402-136c21da5b42 68788-9767 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 20150819 ANDA ANDA062505 Preferred Pharmaceuticals Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68788-9768_b3877a7b-19df-4627-a299-91475dde9181 68788-9768 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20150820 ANDA ANDA086988 Preferred Pharmaceuticals Inc. METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-9769_0adfbac5-3f7d-4c17-a149-e02262b49d54 68788-9769 HUMAN OTC DRUG Pediatric Cough and Cold Medicine Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide LIQUID ORAL 20120727 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc. CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 1; 15; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 68788-9770_6c55a825-701d-44a3-92ab-fd81f9f4fcb0 68788-9770 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20120727 ANDA ANDA078152 Preferred Pharmaceuticals, Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68788-9771_a3129e4c-44a0-46a1-8a34-04f9687b64bb 68788-9771 HUMAN OTC DRUG MILK OF MAGNESIA ORIGINAL magnesium hydroxide LIQUID ORAL 20120726 OTC MONOGRAPH FINAL part331 Preferred Pharmaceuticals, Inc. MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 68788-9772_faf6081e-6b36-4f65-9ec5-09c5cff69ab8 68788-9772 HUMAN OTC DRUG Miconazole 7 Miconazole Nitrate CREAM VAGINAL 20120727 ANDA ANDA074164 Preferred Pharmaceuticals, Inc. MICONAZOLE NITRATE 20 mg/g N 20181231 68788-9773_16f25c5a-14f0-46c6-b4b1-b32e72c82d6b 68788-9773 HUMAN OTC DRUG Loperamide Hydrochloride Loperamide Hydrochloride SOLUTION ORAL 20120727 ANDA ANDA074352 Preferred Pharmaceuticals, Inc. LOPERAMIDE HYDROCHLORIDE 1 mg/5mL N 20181231 68788-9774_684e866e-3780-4a0f-91d3-bea64b813815 68788-9774 HUMAN PRESCRIPTION DRUG Lidocaine and Prilocaine Lidocaine and Prilocaine CREAM TOPICAL 20120726 ANDA ANDA076290 Preferred Pharmaceuticals, Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 68788-9775_2962db9a-a342-4909-818e-e2f1d781481b 68788-9775 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20120725 ANDA ANDA075693 Preferred Pharmaceuticals, Inc. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68788-9776_72383340-31ff-4df4-bbb0-29eaa5a7e07c 68788-9776 HUMAN PRESCRIPTION DRUG HydrOXYzine Hydrochloride HydrOXYzine Hydrochloride SOLUTION ORAL 20150113 ANDA ANDA040010 Preferred Pharmaceuticals, Inc. HYDROXYZINE HYDROCHLORIDE 10 mg/5mL Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 68788-9778_9626465d-7b74-44ad-868d-3bf1a65203e0 68788-9778 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20120725 ANDA ANDA078010 Preferred Pharmaceuticals, Inc. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 68788-9779_c7449c29-5cfa-4852-ab03-c6f06932b682 68788-9779 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20120727 ANDA ANDA075786 Preferred Pharmaceuticals, Inc. FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68788-9780_d0648543-83ee-4928-89c5-1d9d94557ae0 68788-9780 HUMAN PRESCRIPTION DRUG clindamycin phosphate clindamycin phosphate GEL TOPICAL 20120727 ANDA ANDA064160 Preferred Pharmaceuticals, Inc. CLINDAMYCIN PHOSPHATE 10 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 68788-9781_34de07c1-5aae-4704-93c6-4fb70d0e1041 68788-9781 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20120712 ANDA ANDA075584 Preferred Pharmaceuticals,Inc. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 68788-9782_08cd86af-7084-43c7-9d09-426f6d4ddbdb 68788-9782 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20120727 ANDA ANDA074543 Preferred Pharmaceuticals, Inc. ALBUTEROL SULFATE 5 mg/mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 68788-9783_7dee3511-8486-43e9-bf04-e6d1f41dffa7 68788-9783 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir SUSPENSION ORAL 20120727 ANDA ANDA074738 Preferred Pharmaceuticals, Inc. ACYCLOVIR 200 mg/5mL DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 68788-9785_823c8557-e84d-4dec-b3c4-b79821fc5000 68788-9785 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076273 Preferred Pharmaceuticals, Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 68788-9786_492fd5db-12d2-41d7-a63a-6331e82d770c 68788-9786 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20120604 ANDA ANDA065271 Preferred Pharmaceuticals, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9789_f5ca4b7d-15c4-45ea-8354-27df3e2d0517 68788-9789 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20120604 ANDA ANDA077614 Preferred Pharmaceuticals,Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 68788-9790_6e8f402d-abbe-4d35-8901-3f38953cbe47 68788-9790 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120604 ANDA ANDA078906 Preferred Pharmaceuticals, Inc. VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-9791_d8fc529b-9e8c-452f-901e-ead95fac09b8 68788-9791 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20120430 ANDA ANDA073449 Preferred Pharmaceuticals, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-9792_d8fc529b-9e8c-452f-901e-ead95fac09b8 68788-9792 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20120430 ANDA ANDA071851 Preferred Pharmaceuticals, Inc. TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-9793_18d5f8ec-1702-47c0-a827-8218c394233d 68788-9793 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20120430 NDA NDA019129 Preferred Pharmaceuticals, Inc TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-9794_162c30ef-d0b5-4556-a59d-55b3c08d8f0b 68788-9794 HUMAN OTC DRUG Bacitracin Bacitracin OINTMENT TOPICAL 20120430 OTC MONOGRAPH FINAL part333B Preferred Pharmaceuticals, Inc BACITRACIN 500 [USP'U]/g N 20181231 68788-9795_d98534a5-9965-4ec9-b516-d7deea55b250 68788-9795 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20120430 ANDA ANDA090035 Preferred Pharmaceuticals, Inc. FOLIC ACID 1 mg/1 N 20181231 68788-9796_442adf75-bd58-4a80-8bed-5da0eb431386 68788-9796 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20120430 ANDA ANDA077156 Preferred Pharmaceuticals, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68788-9798_14121f79-0e69-40db-994d-3490a49a7815 68788-9798 HUMAN PRESCRIPTION DRUG SUMATRIPTAN SUMATRIPTAN TABLET ORAL 20120604 ANDA ANDA076554 Preferred Pharmaceuticals, Inc. SUMATRIPTAN SUCCINATE 25 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 68788-9799_5705db30-075c-4dd2-893f-eab4984a351e 68788-9799 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION ORAL; TOPICAL 20120430 ANDA ANDA040014 Preferred Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 68788-9800_033cad41-ad99-4395-9324-8530014c08b9 68788-9800 HUMAN OTC DRUG Hydrocortisone Maximum Strength Hydrocortisone CREAM TOPICAL 20120430 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc. HYDROCORTISONE 1 g/100g N 20181231 68788-9801_d0ce87b8-d484-4307-95a9-05705a6caf85 68788-9801 HUMAN OTC DRUG Emetrol Cherry phosphorated carbohydrate SOLUTION ORAL 20120423 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc SUCROSE; PHOSPHORIC ACID 3.74; 21.5 g/5mL; mg/5mL E 20171231 68788-9802_be9e55fb-069c-435a-97d1-32785f504460 68788-9802 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate OINTMENT TOPICAL 20120423 ANDA ANDA074248 Preferred Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9803_e2f82bfd-b99e-47f5-bb05-bb7621417296 68788-9803 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20120423 ANDA ANDA074249 Preferred Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9804_3b1d3c0a-6c75-4344-99e1-058e2168083c 68788-9804 HUMAN PRESCRIPTION DRUG Betamethasone Dipropionate Betamethasone Dipropionate CREAM TOPICAL 20120423 ANDA ANDA078930 Preferred Pharmaceuticals, Inc. BETAMETHASONE DIPROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9805_f1b3bcd0-5743-4477-82d1-a7a847b74147 68788-9805 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20120509 ANDA ANDA077421 Preferred Pharmaceuticals, Inc. LORATADINE 5 mg/5mL N 20181231 68788-9806_c663353e-ae01-4043-8cc5-104cdf8d87dc 68788-9806 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20150831 ANDA ANDA075185 Preferred Pharmaceuticals Inc. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9807_f33b3a7c-3d98-4c44-9c72-7615af3f6ce3 68788-9807 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20120423 ANDA ANDA077912 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9808_f33b3a7c-3d98-4c44-9c72-7615af3f6ce3 68788-9808 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20120423 ANDA ANDA077912 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9809_f33b3a7c-3d98-4c44-9c72-7615af3f6ce3 68788-9809 HUMAN PRESCRIPTION DRUG LISINOPRIL AND HYDROCHLOROTHIAZIDE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET ORAL 20120423 ANDA ANDA077912 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-9810_84a63e5a-d75a-4dc3-b1e2-f0dc2f8169c7 68788-9810 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20120423 ANDA ANDA074937 Preferred Pharmaceuticals, Inc IBUPROFEN 100 mg/5mL N 20181231 68788-9811_149065ec-0c18-43e7-89de-6540bf48207b 68788-9811 HUMAN OTC DRUG TRIPLE ANTIBIOTIC bacitracin zinc neomycin sulfate polymyxin b sulfate OINTMENT TOPICAL 20120425 OTC MONOGRAPH FINAL part333B Preferred Pharmaceuticals, Inc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g E 20171231 68788-9812_b387be7e-e619-46b5-a7cc-2fcc0484e30a 68788-9812 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, CHEWABLE ORAL 20120423 ANDA ANDA075687 Preferred Pharmaceuticals, Inc CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 68788-9813_df69dcce-9990-4839-be62-f50001c27701 68788-9813 HUMAN OTC DRUG good sense tussin cf cough and cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride LIQUID ORAL 20120405 OTC MONOGRAPH FINAL part341 Preferred Pharmaceuticals, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 68788-9814_dc087f3c-1d55-40c3-9d88-ec6424974059 68788-9814 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20120405 ANDA ANDA077511 Preferred Pharmaceuticals, Inc TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 68788-9815_1558526c-9978-4ed9-8391-3e56e84827e1 68788-9815 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin hydrochloride CAPSULE ORAL 20120405 ANDA ANDA075317 Preferred Pharmaceuticals, Inc TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68788-9816_1558526c-9978-4ed9-8391-3e56e84827e1 68788-9816 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin hydrochloride CAPSULE ORAL 20120405 ANDA ANDA075317 Preferred Pharmaceuticals, Inc TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68788-9817_1558526c-9978-4ed9-8391-3e56e84827e1 68788-9817 HUMAN PRESCRIPTION DRUG Terazosin hydrochloride Terazosin hydrochloride CAPSULE ORAL 20120405 ANDA ANDA075317 Preferred Pharmaceuticals, Inc TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 68788-9818_62016bd1-2502-4bca-8274-2caa24fc0c06 68788-9818 HUMAN PRESCRIPTION DRUG Thermazene Silver Sulfadiazine CREAM TOPICAL 20120405 NDA NDA018810 Preferred Pharmaceuticals, Inc SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 68788-9819_59912e7b-7144-449e-b67d-7864437ef7da 68788-9819 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20120405 ANDA ANDA040120 Preferred Pharmaceuticals, Inc PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 68788-9820_5ea5fee2-3905-4426-99f2-0aaa9db1de86 68788-9820 HUMAN PRESCRIPTION DRUG POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE polymyxin B sulfate, trimethoprim sulfate SOLUTION/ DROPS OPHTHALMIC 20120405 NDA AUTHORIZED GENERIC NDA050567 Preferred Pharmaceuticals, Inc POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 68788-9821_d904623b-20ee-4348-8b29-c40d9ada4f94 68788-9821 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120405 ANDA ANDA078402 Preferred Pharmaceuticals, Inc LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9822_d904623b-20ee-4348-8b29-c40d9ada4f94 68788-9822 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120405 ANDA ANDA078402 Preferred Pharmaceuticals, Inc LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9823_d904623b-20ee-4348-8b29-c40d9ada4f94 68788-9823 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120405 ANDA ANDA078402 Preferred Pharmaceuticals, Inc LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9824_623b8554-7ed3-4e55-8a96-5580d12fa771 68788-9824 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20150818 ANDA ANDA091103 Preferred Pharmaceuticals Inc. ESZOPICLONE 3 mg/1 CIV N 20181231 68788-9827_e4d5f9d7-39bc-4608-945b-1f2e51bf1f84 68788-9827 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20120405 ANDA ANDA040682 Preferred Pharmaceuticals, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 68788-9830_50421525-faad-4195-9c7e-c965be6bc056 68788-9830 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20150817 ANDA ANDA075520 Preferred Pharmaceuticals Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-9831_6156f6a0-fc99-4436-b74b-c7ef207c6dfd 68788-9831 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20120604 NDA NDA018877 Preferred Pharmaceuticals, Inc. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 68788-9832_78992ad5-447b-4b69-bf5e-130218fb5be6 68788-9832 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20120604 ANDA ANDA090637 Preferred Pharmaceuticals, Inc. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 68788-9835_bb6f6fcf-a62b-4223-adb2-de81bd89c763 68788-9835 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20120329 ANDA ANDA077752 Preferred Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9836_bb6f6fcf-a62b-4223-adb2-de81bd89c763 68788-9836 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20120329 ANDA ANDA077752 Preferred Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9838_a9f74508-b780-4bd5-90d7-4496bff36931 68788-9838 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20120329 ANDA ANDA090618 Preferred Pharmaceuticals, Inc NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 68788-9839_4a06a04d-855f-4ec4-b1a3-17e50365bcf6 68788-9839 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20120329 ANDA ANDA076045 Preferred Pharmaceuticals, Inc LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9840_4a06a04d-855f-4ec4-b1a3-17e50365bcf6 68788-9840 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20120329 ANDA ANDA076045 Preferred Pharmaceuticals, Inc LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9841_c8d81f3c-0fc5-47c3-ba65-c977029e1fa3 68788-9841 HUMAN PRESCRIPTION DRUG Clindamycin Phosphate clindamycin phosphate CREAM VAGINAL 20120329 ANDA ANDA065139 Preferred Pharmaceuticals, Inc. CLINDAMYCIN PHOSPHATE 20 mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68788-9842_f9a91923-363e-4d61-82d8-60b3e166d959 68788-9842 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20120329 ANDA ANDA074505 Preferred Pharmaceuticals, Inc. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9843_f9a91923-363e-4d61-82d8-60b3e166d959 68788-9843 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20120329 ANDA ANDA074505 Preferred Pharmaceuticals, Inc. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9844_893f8f02-4d36-49fc-9476-05e3c73db116 68788-9844 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120329 ANDA ANDA075022 Preferred Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 68788-9845_893f8f02-4d36-49fc-9476-05e3c73db116 68788-9845 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20120329 ANDA ANDA075022 Preferred Pharmaceuticals, Inc. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 68788-9846_42536515-f5ec-4c97-9b0d-e0469762f2ce 68788-9846 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20120328 ANDA ANDA072234 Preferred Pharmaceuticals, Inc. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 68788-9847_634dedf9-bd7b-456d-be06-a6bac2799fc0 68788-9847 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium POWDER, FOR SUSPENSION ORAL 20120330 NDA NDA050755 Preferred Pharmaceuticals, Inc AMOXICILLIN; CLAVULANATE POTASSIUM 600; 42.9 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-9848_3526c7e1-e3e2-4529-a0c5-6e524a0dd4e4 68788-9848 HUMAN PRESCRIPTION DRUG Econazole Nitrate Econazole Nitrate CREAM TOPICAL 20120329 ANDA ANDA076005 Preferred Pharmaceuticals, Inc. ECONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 68788-9849_e733babc-7065-4cbf-ab6a-df19c3d8af63 68788-9849 HUMAN OTC DRUG GAVILAX Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20120329 ANDA ANDA091077 Preferred Pharmaceuticals, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g E 20171231 68788-9852_54249fdb-1c70-44b7-9296-3cb2315e4b83 68788-9852 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 20120314 ANDA ANDA060456 Preferred Pharmaceuticals, Inc PENICILLIN V POTASSIUM 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9853_54249fdb-1c70-44b7-9296-3cb2315e4b83 68788-9853 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium POWDER, FOR SOLUTION ORAL 20120314 ANDA ANDA060456 Preferred Pharmaceuticals, Inc PENICILLIN V POTASSIUM 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9855_9ac2fad7-0cf6-4756-baf7-891a58658103 68788-9855 HUMAN OTC DRUG Medrox METHYL SALICYLATE, MENTHOL, CAPSAICIN OINTMENT TOPICAL 20120312 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAPSAICIN 20; 5; .0375 g/100g; g/100g; g/100g N 20181231 68788-9856_d5331ecd-70b8-4cc0-baff-afb4aa8d9c28 68788-9856 HUMAN OTC DRUG Hydrocortisone hydrocortisone CREAM TOPICAL 20120312 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals, Inc HYDROCORTISONE 10 mg/g N 20181231 68788-9857_975e236d-17c1-4ee6-8a1e-217fb7921a6e 68788-9857 HUMAN OTC DRUG Docuprene DOCUSATE SODIUM TABLET ORAL 20120312 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals, Inc DOCUSATE SODIUM 100 mg/1 N 20181231 68788-9858_33b163c3-d82f-4ec2-85b1-6e5a5831884c 68788-9858 HUMAN OTC DRUG Artificial Tears Polyvinyl Alcohol SOLUTION/ DROPS OPHTHALMIC 20120313 OTC MONOGRAPH FINAL part349 Preferred Pharmaceuticals, Inc POLYVINYL ALCOHOL, UNSPECIFIED 14 mg/mL N 20181231 68788-9859_805e2851-21a1-406a-912a-57226bdf0b82 68788-9859 HUMAN PRESCRIPTION DRUG ANUCORT-HC Hydrocortisone Acetate SUPPOSITORY RECTAL 20120312 UNAPPROVED DRUG OTHER Preferred Pharmaceuticals, Inc HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9860_bf1ce22b-dd0c-4ec5-b4a3-6f038d69ea95 68788-9860 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20120228 ANDA ANDA071524 Preferred Pharmaceuticals, Inc TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68788-9861_bf1ce22b-dd0c-4ec5-b4a3-6f038d69ea95 68788-9861 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20120228 ANDA ANDA071523 Preferred Pharmaceuticals, Inc TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 68788-9864_8858eeb2-4ace-446b-a8aa-79a34eaff686 68788-9864 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120228 ANDA ANDA071457 Preferred Pharmaceuticals, Inc TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9865_8858eeb2-4ace-446b-a8aa-79a34eaff686 68788-9865 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20120228 ANDA ANDA071456 Preferred Pharmaceuticals, Inc TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9867_abf822a1-6864-444f-8066-6edd1b644d14 68788-9867 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20150814 NDA AUTHORIZED GENERIC NDA020504 Preferred Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-9868_148bb96a-d96f-42fc-a89f-55cacccbab57 68788-9868 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20120228 ANDA ANDA078155 Preferred Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9869_148bb96a-d96f-42fc-a89f-55cacccbab57 68788-9869 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20120228 ANDA ANDA078155 Preferred Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9870_288a65e6-baff-4b38-8467-bf6dff5e63b6 68788-9870 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 20120228 ANDA ANDA064052 Preferred Pharmaceuticals, Inc TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 68788-9871_c236026b-27bd-4d29-ba18-3ad28d0264b8 68788-9871 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 20120228 ANDA ANDA040066 Preferred Pharmaceuticals, Inc SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 68788-9872_e08aebc9-cb88-4e7a-a83d-5d17eb72be50 68788-9872 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20120227 ANDA ANDA077397 Preferred Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 68788-9873_e08aebc9-cb88-4e7a-a83d-5d17eb72be50 68788-9873 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20120227 ANDA ANDA077397 Preferred Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 68788-9874_d8d4603f-6735-4ebb-8fae-112684b1fcb2 68788-9874 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20120227 ANDA ANDA077824 Preferred Pharmaceuticals, Inc RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68788-9875_d8d4603f-6735-4ebb-8fae-112684b1fcb2 68788-9875 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20120227 ANDA ANDA077824 Preferred Pharmaceuticals, Inc RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 68788-9876_3a9635f9-6bec-401e-b847-530c7e012bb1 68788-9876 HUMAN PRESCRIPTION DRUG PRED MILD prednisolone acetate SUSPENSION/ DROPS OPHTHALMIC 20120305 NDA NDA017100 Preferred Pharmaceuticals, Inc PREDNISOLONE ACETATE 1.2 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9877_783b052f-fc03-4cce-a9f9-0ec4e7d9ae55 68788-9877 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120305 ANDA ANDA040525 Preferred Pharmaceuticals, Inc. PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 68788-9878_4a2ee14b-47e9-4a61-8bb6-000a2d44fbd4 68788-9878 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20150814 ANDA ANDA091305 Preferred Pharmaceuticals Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9879_c853d873-5c5d-44ee-b0d2-41a30bcd8210 68788-9879 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20120305 ANDA ANDA074132 Preferred Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-9880_c853d873-5c5d-44ee-b0d2-41a30bcd8210 68788-9880 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20120305 ANDA ANDA074132 Preferred Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-9883_01aa665f-a211-45d0-919c-49206faa675f 68788-9883 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide triamcinolone acetonide CREAM TOPICAL 20120214 ANDA ANDA040671 Preferred Pharmaceuticals, Inc TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9884_51eeffe5-69de-4d54-921d-837cc6eeceda 68788-9884 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20120214 ANDA ANDA075855 Preferred Pharmaceuticals, Inc OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9885_fbf04757-8389-4273-b946-c4a1784bcdea 68788-9885 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150423 ANDA ANDA090649 Preferred Pharmaceuticals, Inc. NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-9886_fbf04757-8389-4273-b946-c4a1784bcdea 68788-9886 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150423 ANDA ANDA090649 Preferred Pharmaceuticals, Inc. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 68788-9889_f2eb5d98-3e22-4abc-bc4d-e6791e7b89e0 68788-9889 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20120214 ANDA ANDA074644 Preferred Pharmaceuticals, Inc. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-9890_f2eb5d98-3e22-4abc-bc4d-e6791e7b89e0 68788-9890 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20120214 ANDA ANDA074644 Preferred Pharmaceuticals, Inc. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 68788-9891_06c5ae9e-58f0-45bc-964f-98912101f5a8 68788-9891 HUMAN PRESCRIPTION DRUG mupirocin Mupirocin OINTMENT TOPICAL 20140214 ANDA ANDA065123 Preferred Pharmaceuticals, Inc. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 68788-9892_98278522-2036-4d89-bcaa-f8c7687bb90a 68788-9892 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20120214 ANDA ANDA077851 Preferred Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68788-9893_98278522-2036-4d89-bcaa-f8c7687bb90a 68788-9893 HUMAN PRESCRIPTION DRUG ondansetron hydrochloride ondansetron hydrochloride TABLET, FILM COATED ORAL 20120214 ANDA ANDA077851 Preferred Pharmaceuticals, Inc. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 68788-9895_24da32ac-670f-4d9a-a052-85f5f012225a 68788-9895 HUMAN PRESCRIPTION DRUG Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate SOLUTION ORAL 20120214 ANDA ANDA040650 Preferred Pharmaceuticals, Inc PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 68788-9896_3207fe4a-0a0b-43de-8ab1-8d85e46d4abe 68788-9896 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20140214 NDA NDA013217 Preferred Pharmaceuticals, Inc. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 68788-9897_16f59161-b962-42a5-8d21-901b181ac024 68788-9897 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20120214 ANDA ANDA077921 Preferred Pharmaceuticals, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9898_16f59161-b962-42a5-8d21-901b181ac024 68788-9898 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20120214 ANDA ANDA077921 Preferred Pharmaceuticals, Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9899_ff81f030-e320-4193-98f7-a619b9a78b18 68788-9899 HUMAN PRESCRIPTION DRUG Medroxyprogesterone Acetate Medroxyprogesterone Acetate TABLET ORAL 20120213 ANDA ANDA040159 Preferred Pharmaceuticals, Inc. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68788-9900_040e89a6-3a96-489a-bf02-38e20f1f0199 68788-9900 HUMAN PRESCRIPTION DRUG PROAIR HFA albuterol sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20120213 NDA NDA021457 Preferred Pharmaceuticals, Inc ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 68788-9901_3fc3be75-446f-4380-88c8-ccbde09fb75a 68788-9901 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20120213 ANDA ANDA040197 Preferred Pharmaceuticals, Inc. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68788-9902_823fcf29-0adf-40b2-94af-df06771a9ad5 68788-9902 HUMAN PRESCRIPTION DRUG Clobetasol Propionate Clobetasol Propionate CREAM TOPICAL 20120130 ANDA ANDA074220 Preferred Pharmaceuticals, Inc. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9903_4d07e70b-8384-4726-ba6c-eff00c72af62 68788-9903 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole SHAMPOO, SUSPENSION TOPICAL 20120130 ANDA ANDA076419 Preferred Pharmaceuticals, Inc. KETOCONAZOLE 20 mg/mL Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-9906_12ea06ba-cf81-4622-8811-a4b2706dec07 68788-9906 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120130 ANDA ANDA075927 Preferred Pharmaceuticals, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68788-9907_12ea06ba-cf81-4622-8811-a4b2706dec07 68788-9907 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120130 ANDA ANDA075927 Preferred Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 68788-9908_87bbca00-ce2b-401b-bad4-2942400c38f5 68788-9908 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20120130 ANDA ANDA078671 Preferred Pharmaceuticals, Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9909_87bbca00-ce2b-401b-bad4-2942400c38f5 68788-9909 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20120130 ANDA ANDA078671 Preferred Pharmaceuticals, Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9910_51361137-7515-4bd1-934d-04c1c5e4cf89 68788-9910 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120130 ANDA ANDA076063 Preferred Pharmaceuticals, Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9911_51361137-7515-4bd1-934d-04c1c5e4cf89 68788-9911 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120130 ANDA ANDA076063 Preferred Pharmaceuticals, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9912_51361137-7515-4bd1-934d-04c1c5e4cf89 68788-9912 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20120130 ANDA ANDA076063 Preferred Pharmaceuticals, Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 68788-9914_0161b2ab-35bd-4fb5-a6a5-b52d58e232fd 68788-9914 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET, FILM COATED ORAL 20150519 ANDA ANDA065308 Preferred Pharmaceuticali Inc. CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9915_fb07ed6c-f336-4fda-8a62-bad2e2a09e64 68788-9915 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20120130 ANDA ANDA075638 Preferred Pharmaceuticals, Inc. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 68788-9917_58ee1a44-f76d-42b5-987d-a22c3e90e10f 68788-9917 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20120130 ANDA ANDA077537 Preferred Pharmaceuticals, Inc. GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68788-9918_9735a0d2-3ff4-41c4-b6fd-daf9bfef1eca 68788-9918 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20120130 ANDA ANDA074305 Preferred Pharmaceuticals, Inc. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 68788-9919_d58e721c-0487-4693-8463-9872ebaedfd7 68788-9919 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20120130 ANDA ANDA040412 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-9920_d58e721c-0487-4693-8463-9872ebaedfd7 68788-9920 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20120130 ANDA ANDA040412 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-9921_9fb300b6-1bbc-4f6d-a58c-49b57b0a5249 68788-9921 HUMAN PRESCRIPTION DRUG GENTAMICIN SULFATE gentamicin sulfate SOLUTION/ DROPS OPHTHALMIC 20140325 ANDA ANDA062452 Preferred Pharmaceuticals, Inc. GENTAMICIN SULFATE 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 68788-9922_8cec0cb8-2a1c-4d1a-8e09-da520f05f56c 68788-9922 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20120127 ANDA ANDA085025 Preferred Pharmaceuticals, Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9922_a7562cb0-caab-4719-8186-7d5083445f46 68788-9922 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20170508 ANDA ANDA085025 Preferred Pharmaceuticals Inc. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9923_f732f9a3-a574-470f-b143-37cdf6fd6110 68788-9923 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20120127 ANDA ANDA200651 Preferred Pharmaceuticals, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 68788-9924_07c9d78e-ded9-400e-bc9b-1c142dad6d6b 68788-9924 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 20120118 ANDA ANDA064065 Preferred Pharmaceuticals, Inc. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 68788-9925_6b6f12eb-5552-4f77-a426-d48a564b2b89 68788-9925 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20120118 ANDA ANDA077570 Preferred Pharmaceuticals, Inc. FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9926_7636b432-53df-44f3-aeb1-e3abc9812bd1 68788-9926 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20120118 ANDA ANDA076077 Preferred Pharmaceuticals, Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68788-9927_7636b432-53df-44f3-aeb1-e3abc9812bd1 68788-9927 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20120118 ANDA ANDA076077 Preferred Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68788-9928_9abf6721-b861-4620-b669-b4f9e6b32151 68788-9928 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20120118 ANDA ANDA075009 Preferred Pharmaceuticals, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9929_55dbfab7-fa2a-4780-bc76-97ab55580e43 68788-9929 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20120117 ANDA ANDA075074 Preferred Pharmaceuticals, Inc. ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9930_55dbfab7-fa2a-4780-bc76-97ab55580e43 68788-9930 HUMAN PRESCRIPTION DRUG Etodolac Etodolac CAPSULE ORAL 20120117 ANDA ANDA075078 Preferred Pharmaceuticals, Inc. ETODOLAC 300 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9931_5cd8dee8-2ddd-446a-93ed-c44f9897f76e 68788-9931 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20120117 ANDA ANDA075483 Preferred Pharmaceuticals, Inc. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-9932_5cd8dee8-2ddd-446a-93ed-c44f9897f76e 68788-9932 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20120117 ANDA ANDA075483 Preferred Pharmaceuticals, Inc. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-9933_5cd8dee8-2ddd-446a-93ed-c44f9897f76e 68788-9933 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20120117 ANDA ANDA075483 Preferred Pharmaceuticals, Inc. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-9934_124a474b-f36f-49f4-9b86-18318fd6d6c7 68788-9934 HUMAN PRESCRIPTION DRUG Dicyclomine Dicyclomine Hydrochloride TABLET ORAL 19961001 ANDA ANDA040161 Preferred Pharmaceuticals, Inc DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68788-9935_4159077c-81b0-4b1e-849f-beda3b5e0aff 68788-9935 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20120117 ANDA ANDA040204 Preferred Pharmaceuticals, Inc DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 68788-9936_77a07e29-1b3f-4b3a-8567-1c476cea27db 68788-9936 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20120117 ANDA ANDA077749 Preferred Pharmaceuticals, Inc. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9937_77a07e29-1b3f-4b3a-8567-1c476cea27db 68788-9937 HUMAN PRESCRIPTION DRUG Diazepam diazepam TABLET ORAL 20120117 ANDA ANDA077749 Preferred Pharmaceuticals, Inc. DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9938_0830c5cd-3704-4fca-9d89-44150eecf632 68788-9938 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 20120117 ANDA ANDA088238 Preferred Pharmaceuticals, Inc. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9939_0830c5cd-3704-4fca-9d89-44150eecf632 68788-9939 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 20120117 ANDA ANDA088160 Preferred Pharmaceuticals, Inc. DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68788-9940_fbbebd0a-e97c-4634-a1ce-7b6c1c197ec3 68788-9940 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20120117 ANDA ANDA074869 Preferred Pharmaceuticals, Inc. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9941_fbbebd0a-e97c-4634-a1ce-7b6c1c197ec3 68788-9941 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20120117 ANDA ANDA074869 Preferred Pharmaceuticals, Inc. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9942_f63ede01-4d16-4880-84da-33cffaa1df27 68788-9942 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20120116 ANDA ANDA065061 Preferred Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68788-9943_f63ede01-4d16-4880-84da-33cffaa1df27 68788-9943 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20120116 ANDA ANDA065061 Preferred Pharmaceuticals, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 68788-9944_eb623fb2-a7ee-422b-a9db-c450f26ebdde 68788-9944 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20120112 ANDA ANDA076673 Preferred Pharmaceuticals, Inc. CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 68788-9946_c76d5a81-cdc3-4de7-a3aa-b2f5525f48a2 68788-9946 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20120112 ANDA ANDA076402 Preferred Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-9947_c76d5a81-cdc3-4de7-a3aa-b2f5525f48a2 68788-9947 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, FILM COATED ORAL 20120112 ANDA ANDA076402 Preferred Pharmaceuticals, Inc. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 68788-9948_4a28c0f6-1adb-4c57-bfc0-b6d26bc5f152 68788-9948 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20120112 ANDA ANDA065387 Preferred Pharmaceuticals, Inc. AMOXICILLIN 250 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9949_4a28c0f6-1adb-4c57-bfc0-b6d26bc5f152 68788-9949 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin POWDER, FOR SUSPENSION ORAL 20120112 ANDA ANDA065387 Preferred Pharmaceuticals, Inc. AMOXICILLIN 125 mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 68788-9950_01ebc690-6e21-4855-aad6-1f4e48691dec 68788-9950 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20080118 ANDA ANDA065248 Preferred Pharmaceuticals, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9951_01ebc690-6e21-4855-aad6-1f4e48691dec 68788-9951 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20120305 ANDA ANDA065248 Preferred Pharmaceuticals, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9955_0f2cb793-ff1f-40fc-9870-c225ff30a397 68788-9955 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20120110 ANDA ANDA076048 Preferred Pharmaceuticals, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 68788-9956_6fff1cea-f55f-4733-8a83-05f14af14760 68788-9956 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20120110 ANDA ANDA065234 Preferred Pharmaceuticals, Inc. CEPHALEXIN 125 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9957_6fff1cea-f55f-4733-8a83-05f14af14760 68788-9957 HUMAN PRESCRIPTION DRUG cephalexin Cephalexin FOR SUSPENSION ORAL 20120110 ANDA ANDA065234 Preferred Pharmaceuticals, Inc. CEPHALEXIN 250 mg/5mL Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 68788-9958_b50c4a22-d65f-4b6d-9544-5da0035ca5ba 68788-9958 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20120110 ANDA ANDA065246 Preferred Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9959_b50c4a22-d65f-4b6d-9544-5da0035ca5ba 68788-9959 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin POWDER, FOR SUSPENSION ORAL 20120110 ANDA ANDA065246 Preferred Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9960_7c001472-c36b-4ce2-88c5-0a73aafee6e1 68788-9960 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20120109 NDA NDA050564 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-9961_7c001472-c36b-4ce2-88c5-0a73aafee6e1 68788-9961 HUMAN PRESCRIPTION DRUG amoxicillin and clavulanate potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20120109 NDA NDA050720 Preferred Pharmaceuticals, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 68788-9965_9c375c7a-f51d-4f64-8e8e-33ec65296b7e 68788-9965 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20150505 ANDA ANDA040907 Preferred Pharmaceuticals, Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 68788-9966_e630b550-e29e-49c6-9b46-4d248387264c 68788-9966 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20150505 ANDA ANDA077870 Preferred Pharmaceuticals Inc. GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 68788-9967_f9a7a507-0e76-40c3-9205-8d492398b6ee 68788-9967 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20150501 ANDA ANDA078722 Preferred Pharmaceuticals, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-9968_c919c197-9143-4461-aa20-ad4d59a447be 68788-9968 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20151014 ANDA ANDA090460 Preferred Pharmaceuticals Inc. ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 68788-9969_9f5af778-dd60-47a3-b643-9208e1535e04 68788-9969 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20150413 ANDA ANDA073554 Preferred Pharmaceuticals, Inc. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 68788-9970_b8cf1f1d-6013-49ab-ae4f-1d22ddf2e03e 68788-9970 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium POWDER, FOR SUSPENSION ORAL 20150521 ANDA ANDA065420 Preferred Pharmaceuticals Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 600; 600 mg/5mL; mg/5mL Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 68788-9971_3d63318a-c3b0-48fd-9775-a3e56e2df73d 68788-9971 HUMAN OTC DRUG All Day Relief Naproxen Sodium Tablet, coated TABLET ORAL 20150506 ANDA ANDA090545 Preferred Pharmaceuticals Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 68788-9973_a189b207-db40-46fd-bdf0-046de055287e 68788-9973 HUMAN OTC DRUG LubriFresh P.M. white petrolatum mineral oil OINTMENT OPHTHALMIC 20150507 OTC MONOGRAPH FINAL part349 Preferred Pharmaceuticals Inc. MINERAL OIL; PETROLATUM 150; 830 mg/g; mg/g N 20181231 68788-9975_793a3b58-4b9f-4676-ad71-b474c3a46dfd 68788-9975 HUMAN OTC DRUG LidoPro Patch Lidocaine, Menthol, and Methyl Salicylate PATCH TOPICAL 20150507 OTC MONOGRAPH NOT FINAL part348 Preferred Pharmaceuticals Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE .04; .05; .04 1/1; 1/1; 1/1 N 20181231 68788-9976_29e39a90-a86b-4eaa-8bee-48507dd8316e 68788-9976 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20150501 ANDA ANDA040823 Preferred Pharmaceuticals, Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 68788-9977_036f4e10-8292-4b0b-8cfb-ba6c879cb103 68788-9977 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20150416 ANDA ANDA065225 Preferred Pharmaceuticals, Inc. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 68788-9979_cb60126b-be62-4035-ac97-f73ad4818ed2 68788-9979 HUMAN OTC DRUG Eye Wash water SOLUTION OPHTHALMIC 20100913 OTC MONOGRAPH FINAL part349 Preferred Pharmaceuticals, Inc. WATER 99.05 mL/100mL N 20181231 68788-9981_24ee4a40-ccd3-4a03-8409-2e21b1c780c0 68788-9981 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20150416 ANDA ANDA077666 Preferred Pharmaceuticals, Inc. MIRTAZAPINE 15 mg/1 N 20181231 68788-9982_59e02106-8a3e-45cf-b459-ae125663ac38 68788-9982 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20150416 ANDA ANDA071404 Preferred Pharmaceuticals, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68788-9983_535c4cda-8e7f-4f2c-ad76-37e028c700ae 68788-9983 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20150420 ANDA ANDA202357 Preferred Pharmaceuticals, Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 68788-9984_aceef6fe-fe5f-463e-8d3f-6aa2eb422397 68788-9984 HUMAN PRESCRIPTION DRUG valacyclovir hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20150504 ANDA ANDA201506 Preferred Pharmaceuticals, Inc. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 68788-9985_25ea855b-fef0-4436-b830-66aead7b621e 68788-9985 HUMAN PRESCRIPTION DRUG Cetirizine hydrochloride Cetirizine hydrochloride SOLUTION ORAL 20150420 ANDA ANDA078870 Preferred Pharmaceuticals, Inc. CETIRIZINE HYDROCHLORIDE 1 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 68788-9986_a4487641-4454-4c5d-b512-a2b29d4babc3 68788-9986 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20150507 ANDA ANDA090467 Preferred Pharmaceuticals, Inc. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 68788-9988_5bfddbeb-e2ac-4688-8310-6a51560f64e9 68788-9988 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20150420 ANDA ANDA076658 Preferred Pharmaceuticals, Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 68788-9990_09508f47-03b7-481d-8c6b-fba9680861df 68788-9990 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 20150420 ANDA ANDA074903 Preferred Pharmaceuticals, Inc. ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9991_0aa20740-663f-4812-b2e0-c7258174617a 68788-9991 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140415 ANDA ANDA091103 Preferred Pharmaceuticals, Inc. ESZOPICLONE 2 mg/1 CIV N 20181231 68788-9992_50e7b305-4b74-402f-8023-7226d8f6f97e 68788-9992 HUMAN OTC DRUG SENNA TIME SENNOSIDES TABLET, COATED ORAL 20130329 OTC MONOGRAPH NOT FINAL part334 Preferred Pharmaceuticals, Inc. SENNOSIDES A AND B 8.6 mg/1 N 20181231 68788-9993_c8de0b65-e76b-4f03-99d9-7a1d93e5bb2f 68788-9993 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150429 NDA AUTHORIZED GENERIC NDA020998 Preferred Pharmaceuticals, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 68788-9997_4aa8d821-097d-4485-a045-993aa04bcf72 68788-9997 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20150416 ANDA ANDA074174 Preferred Pharmaceuticals, Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 68791-100_d5e3e9d0-a9a9-472a-ae49-54d4eb632ba4 68791-100 HUMAN PRESCRIPTION DRUG pediapred PREDNISOLONE SODIUM PHOSPHATE SOLUTION ORAL 20030326 ANDA ANDA075183 Royal Pharmaceuticals PREDNISOLONE SODIUM PHOSPHATE 5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 68791-101_7d77937f-c3a3-49ec-85f0-cbd991c31e66 68791-101 HUMAN PRESCRIPTION DRUG Derma-Smoothe/FS fluocinolone acetonide OIL TOPICAL 19950216 NDA NDA019452 Royal Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68791-102_62936c57-d43b-4d60-b02a-ccf2b85a8963 68791-102 HUMAN PRESCRIPTION DRUG Derma-Smoothe/FS fluocinolone acetonide OIL TOPICAL 19950216 NDA NDA019452 Royal Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68791-103_9039b56d-17da-46ac-bfe4-32d2d20917ea 68791-103 HUMAN PRESCRIPTION DRUG DermOtic fluocinolone acetonide OIL AURICULAR (OTIC) 20051109 NDA NDA019452 Royal Pharmaceuticals FLUOCINOLONE ACETONIDE .11 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68791-104_75647b4d-199b-49db-88e1-45841d0075da 68791-104 HUMAN PRESCRIPTION DRUG PEDIAPRED Prednisolone Sodium Phosphate SOLUTION ORAL 20170714 NDA NDA019157 Royal Pharmaceuticals PREDNISOLONE SODIUM PHOSPHATE 5 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 68796-5626_6dbd157a-7539-4992-9618-f59d7cf61084 68796-5626 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20031001 UNAPPROVED MEDICAL GAS Covenant Home Medical OXYGEN 99 L/100L E 20171231 68803-612_5d4ef1a3-90d0-7e76-e053-2a91aa0a46dd 68803-612 HUMAN PRESCRIPTION DRUG VISIONBLUE Trypan Blue INJECTION, SOLUTION INTRAOCULAR; OPHTHALMIC 20041216 NDA NDA021670 D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. TRYPAN BLUE .3 mg/.5mL Diagnostic Dye [EPC],Dyes [MoA] N 20181231 68803-672_5d4ef1a3-90bc-7e76-e053-2a91aa0a46dd 68803-672 HUMAN PRESCRIPTION DRUG MEMBRANEBLUE trypan blue INJECTION, SOLUTION INTRAOCULAR; OPHTHALMIC 20090220 NDA NDA022278 Dutch Ophthalmic Research Center (International) B.V. TRYPAN BLUE .75 mg/.5mL Diagnostic Dye [EPC],Dyes [MoA] N 20181231 68807-102_c864281a-a08e-455b-9532-f81adcb3c928 68807-102 HUMAN OTC DRUG Renewing Antioxidant Treatment SPF 6 GNLD International Avobenzone, Octyl Methoxycinnamate CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part352 Temmentec AG OCTINOXATE; AVOBENZONE 6; 1.7 g/100g; g/100g E 20171231 68807-301_34f18c0f-1669-44f9-b200-2bededba9ec5 68807-301 HUMAN PRESCRIPTION DRUG La Prairie Switzerland Cellular Radiance Emulsion Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part352 Temmentec Ag AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 kg/100kg; kg/100kg; kg/100kg E 20171231 68807-302_fae03bc7-842d-4ab8-924c-4066b2427817 68807-302 HUMAN OTC DRUG Anti-Aging Day Broad Spectrum SPF 30 La Prairie Group AG Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20130116 OTC MONOGRAPH FINAL part352 Temmentec AG AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 7.5; 5; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68807-303_4df151ee-27bb-4151-b7f9-0933ff159252 68807-303 HUMAN OTC DRUG Anti-Aging Eye Broad Spectrum SPF 15 la prairie Switzerland Avbenzone, Octinoxate, Octisalate CREAM TOPICAL 20130114 OTC MONOGRAPH FINAL part352 Temmentec Ag AVOBENZONE; OCTINOXATE; OCTISALATE 2; 7.5; 3 g/100mL; g/100mL; g/100mL N 20181231 68807-304_7824f778-9b68-4c3c-8a44-7eeb38e71150 68807-304 HUMAN OTC DRUG Anti-Aging Emulsion SPF 30 Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20110513 OTC MONOGRAPH FINAL part352 Temmentec AG AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.8; 7.5; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68807-305_6b5e723a-7aa3-4961-a696-b01c0293b9f7 68807-305 HUMAN OTC DRUG Advanced Marine Biology Day SPF 20 La Prairie Group AG Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20130116 OTC MONOGRAPH FINAL part352 Temmentec Ag AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100mL; g/100mL; g/100mL E 20171231 68807-306_156f2835-aea6-4313-9063-a94fa71b68a6 68807-306 HUMAN OTC DRUG Cellular Radiance Emulsion SPF 30 La Prairie Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20130111 OTC MONOGRAPH FINAL part352 Temmentec Ag AVOBENZONE; OCTINOXATE; OCTISALATE 75; 50; 30 mg/mL; mg/mL; mg/mL N 20181231 68807-307_82200124-64e4-4ce1-b9f2-9c939d50a147 68807-307 HUMAN OTC DRUG Sun Protection Emulsion Face Broad Spectrum SPF 30 La Prairie Group Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20110214 OTC MONOGRAPH FINAL part352 Temmentec Ag HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 10; 2.6; 2.4; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 68807-308_40f5c2ef-1993-4444-a319-a1cbdc229582 68807-308 HUMAN OTC DRUG Sun Protection Body Sunscreen Broad Spectrum SPF 30 La Prairie Avobenzone, Homosalate, Octisalate, Oxybenzone LOTION TOPICAL 20130405 OTC MONOGRAPH FINAL part352 Temmentec Ag AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 7; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 68807-309_aee73fb2-29f2-4941-b32a-3c7ee9745e12 68807-309 HUMAN OTC DRUG Ultra Protection Stick Broad Spectrum SPF 40 La Prairie Switzerland Avobenzone, Homosalate, Octisalate, Oxybenzone STICK TOPICAL 20130404 OTC MONOGRAPH FINAL part352 Temmentec Ag AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 7; 5; 2 g/100g; g/100g; g/100g; g/100g E 20171231 68807-310_227f176c-ccc3-4f79-b7c9-f2c85d4d3e22 68807-310 HUMAN OTC DRUG Cellular Swiss UV Protection Veil Sunscreen Broad Spectrum SPF 50 La Prairie Octinoxate, Oxybenzone, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150812 OTC MONOGRAPH NOT FINAL part352 Temmentec Ag OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 1.9; 18.6 1/100mL; 1/100mL; 1/100mL; 1/100mL N 20181231 68807-311_86274685-4951-4a58-afbe-e7776d64557f 68807-311 HUMAN OTC DRUG Cellular Swiss Sunscreen Broad Spectrum SPF 30 Octinoxate, Zinc Oxide CREAM TOPICAL 20150610 OTC MONOGRAPH FINAL part352 Temmentec Ag OCTINOXATE; ZINC OXIDE 7.5; 7.4 g/78.4kg; g/78.4kg N 20181231 68807-312_04e25cac-f699-410d-b23f-0249f6256012 68807-312 HUMAN OTC DRUG Cellular Swiss Sunscreen Broad Spectrum SPF 30 Octinoxate, Zinc Oxide CREAM TOPICAL 20150609 OTC MONOGRAPH FINAL part352 Temmentec Ag OCTINOXATE; ZINC OXIDE 7.5; 7.4 g/78.4kg; g/78.4kg N 20181231 68807-313_358f3cad-89d6-42f1-befa-2c810a8b8c4a 68807-313 HUMAN OTC DRUG Cellular Swiss Sunscreen Broad Spectrum SPF 30 Octinoxate, Zinc Oxide CREAM TOPICAL 20150609 OTC MONOGRAPH FINAL part352 Temmentec Ag OCTINOXATE; ZINC OXIDE 7.5; 7.4 g/78.4kg; g/78.4kg N 20181231 68807-314_6ac8559b-66a9-46e1-9cd1-e9c560262c22 68807-314 HUMAN OTC DRUG Cellular Swiss Sunscreen Broad Spectrum SPF 30 Octinoxate, Zinc Oxide CREAM TOPICAL 20150609 OTC MONOGRAPH FINAL part352 Temmentec Ag OCTINOXATE; ZINC OXIDE 7.5; 7.4 g/78.4kg; g/78.4kg N 20181231 68807-315_d155f599-ab78-40c5-afd8-ab15448b6428 68807-315 HUMAN OTC DRUG White Caviar Illuminating Hand Sunscreen Broad Spectrum SPF 15 La Prairie Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20130301 OTC MONOGRAPH FINAL part352 Temmentec AG AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 5; 4; 3; 1.5 g/100kg; g/100kg; g/100kg; g/100kg; g/100kg N 20181231 68807-316_65d2dc53-994f-4601-a9c6-348c7b4c9b3f 68807-316 HUMAN OTC DRUG Anti-Aging Day Broad Spectrum SPF 30 La Prairie Group AG Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20130116 OTC MONOGRAPH FINAL part352 Temmentec AG AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 7.5; 5; 2.5 g/100kg; g/100kg; g/100kg; g/100kg N 20181231 68807-317_d4ada3cf-821a-4ab0-b5ff-67287ec7fd69 68807-317 HUMAN OTC DRUG Anti-Aging Eye Broad Spectrum SPF 15 la prairie Switzerland Avbenzone, Octinoxate, Octisalate CREAM TOPICAL 20130114 OTC MONOGRAPH FINAL part352 Temmentec Ag AVOBENZONE; OCTINOXATE; OCTISALATE 2; 7.5; 3 g/100kg; g/100kg; g/100kg N 20181231 68807-318_579271be-9ebb-4869-8d94-98a6e6a09a7d 68807-318 HUMAN OTC DRUG Anti-Aging Emulsion SPF 30 Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20110513 OTC MONOGRAPH FINAL part352 Temmentec AG AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.8; 7.5; 5; 4 g/100kg; g/100kg; g/100kg; g/100kg N 20181231 68807-319_9b292ba6-c0c4-42b1-ace7-696b8cb85417 68807-319 HUMAN OTC DRUG Advanced Marine Biology Day SPF 20 La Prairie Group AG Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20130116 OTC MONOGRAPH FINAL part352 Temmentec Ag AVOBENZONE; OCTINOXATE; OCTISALATE 3; 7.5; 5 g/100kg; g/100kg; g/100kg E 20171231 68807-320_aa2c9666-c111-4c31-96c1-ac36fdda8b22 68807-320 HUMAN OTC DRUG Cellular Radiance Emulsion SPF 30 La Prairie Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20130111 OTC MONOGRAPH FINAL part352 Temmentec Ag AVOBENZONE; OCTINOXATE; OCTISALATE 75; 50; 30 mg/100kg; mg/100kg; mg/100kg N 20181231 68807-321_7426198b-4344-4cc1-af69-6abc5a20c854 68807-321 HUMAN OTC DRUG Sun Protection Emulsion Face Broad Spectrum SPF 30 La Prairie Group Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20110214 OTC MONOGRAPH FINAL part352 Temmentec Ag HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 10; 2.6; 2.4; 5; 3 g/100kg; g/100kg; g/100kg; g/100kg; g/100kg E 20171231 68807-322_cfb72ffb-7269-4369-9cf9-eec6cc497e6b 68807-322 HUMAN OTC DRUG Sun Protection Body Sunscreen Broad Spectrum SPF 30 La Prairie Avobenzone, Homosalate, Octisalate, Oxybenzone LOTION TOPICAL 20130405 OTC MONOGRAPH FINAL part352 Temmentec Ag AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 7; 5; 5 g/100kg; g/100kg; g/100kg; g/100kg E 20171231 68807-323_cf8104fa-0da5-4ac9-a2ae-8c11b727e869 68807-323 HUMAN OTC DRUG Ultra Protection Stick Broad Spectrum SPF 40 La Prairie Switzerland Avobenzone, Homosalate, Octisalate, Oxybenzone STICK TOPICAL 20130404 OTC MONOGRAPH FINAL part352 Temmentec Ag AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 7; 5; 2 g/100kg; g/100kg; g/100kg; g/100kg E 20171231 68807-324_b3aa1991-5eb9-4447-9f2f-77a107c1967b 68807-324 HUMAN OTC DRUG Cellular Swiss UV Protection Veil Sunscreen Broad Spectrum SPF 50 La Prairie Octinoxate, Oxybenzone, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150812 OTC MONOGRAPH NOT FINAL part352 Temmentec Ag OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 1.9; 18.6 1/100kg; 1/100kg; 1/100kg; 1/100kg N 20181231 68807-325_ad0b2c96-8610-43a0-83f6-db3c1d0ceb1b 68807-325 HUMAN OTC DRUG Anti-Wrinkle Day Cream Suncreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20160414 OTC MONOGRAPH FINAL part352 Temmentec AG AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.7; 9; 4.5; 9 g/100kg; g/100kg; g/100kg; g/100kg E 20171231 68807-326_92cfb792-8bf4-4cfc-ac91-31bd01adfa1a 68807-326 HUMAN OTC DRUG Line Interception Power Duo Day Cream Suncreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20160414 OTC MONOGRAPH FINAL part352 Temmentec AG AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.7; 9; 4.5; 9 g/100kg; g/100kg; g/100kg; g/100kg N 20181231 68809-544_839ed82a-ef77-4bad-af8b-c28f86e9d423 68809-544 HUMAN OTC DRUG Heavy Duty Hand Cleaner CHLOROXYLENOL SOAP TOPICAL 20040427 OTC MONOGRAPH NOT FINAL part333E MPI Chemicals, Inc. CHLOROXYLENOL 3 mg/mL E 20171231 68814-111_e7d16a16-da4c-4510-b314-5d1bfd710b9a 68814-111 HUMAN OTC DRUG Molton Brown Anti-Perspirant Stick Cool Buchu Aluminum Zirconium Tetrachlorohydrex STICK TOPICAL 20100401 OTC MONOGRAPH FINAL part350 Molton Brown Ltd. ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g E 20171231 68814-128_bb2c37df-ecd6-483b-b20d-3a13da408485 68814-128 HUMAN OTC DRUG Karanja Tree Sunshield SPF 30 Molton Brown Skin Care Avobenzone, Ensulizole, Octinoxate, Octocrylene CREAM TOPICAL 20101230 OTC MONOGRAPH NOT FINAL part352 Molton Brown LTD AVOBENZONE; ENSULIZOLE; OCTINOXATE; OCTOCRYLENE 3; 3; 7.5; 2 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 68814-145_0df8d86b-ecef-4e93-a220-c427ade23f31 68814-145 HUMAN OTC DRUG Sport Anti-Perpirant Sportstick Molton Brown London Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20130115 OTC MONOGRAPH FINAL part350 Molton Brown LTD (UK) ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 14.4 g/75g E 20171231 68814-250_e235ef04-0b51-4d82-a518-f1bb2b37236c 68814-250 HUMAN OTC DRUG Skin Firm Lipoamino hydrator SPF 15 Molton Brown Avobenzone, Ensulizole, Octinoxate, Octocrylene LOTION TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 Molton Brown LTD AVOBENZONE; ENSULIZOLE; OCTINOXATE; OCTOCRYLENE 3; 1; 5; 2 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 68814-489_41bacb28-a86b-4c21-8e75-6dc4bb07eb1b 68814-489 HUMAN OTC DRUG Re-Charge Black Pepper Antiperspirant Molton Brown Aluminum Zirconium Tetrachlorohydrex GLY STICK TOPICAL 20101123 OTC MONOGRAPH FINAL part350 Molton Brown LTD ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g E 20171231 68817-134_8b78c8ab-6766-4120-8213-eaa30731d3e4 68817-134 HUMAN PRESCRIPTION DRUG ABRAXANE Paclitaxel INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INTRAVENOUS 20050210 NDA NDA021660 Abraxis BioScience, LLC PACLITAXEL 100 mg/20mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 68820-068_217a3119-7c11-4d37-80d9-e331947c7d5b 68820-068 HUMAN PRESCRIPTION DRUG Mematine Hydrochloride Mematine Hydrochloride TABLET, FILM COATED ORAL 20150111 ANDA ANDA090044 Orchid Chemicals & Pharmaceuticals Limited MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 68820-069_217a3119-7c11-4d37-80d9-e331947c7d5b 68820-069 HUMAN PRESCRIPTION DRUG Mematine Hydrochloride Mematine Hydrochloride TABLET, FILM COATED ORAL 20150111 ANDA ANDA090044 Orchid Chemicals & Pharmaceuticals Limited MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 68820-105_4b03f280-f14e-4a58-9ebc-c32d56b2848c 68820-105 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120707 ANDA ANDA091123 Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd.) VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 68820-106_4b03f280-f14e-4a58-9ebc-c32d56b2848c 68820-106 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120707 ANDA ANDA091123 Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd.) VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 68820-107_4b03f280-f14e-4a58-9ebc-c32d56b2848c 68820-107 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120707 ANDA ANDA091123 Orchid Healthcare (a division of Orchid Chemicals & Pharmaceuticals Ltd.) VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 68826-120_4f8fb5e1-95c1-0a90-e054-00144ff88e88 68826-120 HUMAN OTC DRUG Allergies Relief Diphenhydramine HCl TABLET, FILM COATED ORAL 20151001 20180402 OTC MONOGRAPH FINAL part341 Medex Merchandising, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 68826-140_4f8fcfb8-a198-4ccf-e054-00144ff8d46c 68826-140 HUMAN OTC DRUG Medex Anti-Diarrheal Relief Loperamide HCl TABLET ORAL 20151020 20180801 ANDA ANDA074091 Medex Merchandising, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 68826-180_4f9025a8-6d4e-5866-e054-00144ff8d46c 68826-180 HUMAN OTC DRUG Pain Away Plus acetaminophen, aspirin, caffeine TABLET, FILM COATED ORAL 20151015 20190301 OTC MONOGRAPH NOT FINAL part343 Medex Merchandising LLC CAFFEINE; ASPIRIN; ACETAMINOPHEN 65; 250; 250 mg/1; mg/1; mg/1 N 20181231 68828-046_540c038c-5736-4ce9-a4d6-cda4623d1444 68828-046 HUMAN OTC DRUG OIL CONTROLLING MAKEUP SPF 15 OCTINOXATE OCTISALATE OXYBENZONE LOTION TOPICAL 20120419 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-047_18abcbd7-0299-4c20-9fd7-317a988b891d 68828-047 HUMAN OTC DRUG SKIN DEFENSE MAKEUP SPF 15 OCTINOXATE OCTISALATE OXYBENZONE LOTION TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-048_c0aa639c-80e2-4ee9-bdff-20156248716a 68828-048 HUMAN OTC DRUG MOISTURIZING MAKEUP SPF 15 OCTINOXATE OCTISALATE OXYBENZONE LOTION TOPICAL 20120501 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-049_c7e9de04-14d8-4e1b-b480-05711986a194 68828-049 HUMAN OTC DRUG JAFRA PRO FACE LIFT SPF 20 OCTOCRYLENE OCTISALATE HOMOSALATE AVOBENZONE LOTION TOPICAL 20120504 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE 7; 5; 5; 3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-052_5f535b60-24e3-4113-937e-52a381023a91 68828-052 HUMAN OTC DRUG JAFRA DAILY FLORAL MIST FOR WOMEN ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY LOTION TOPICAL 20120424 OTC MONOGRAPH FINAL part350 JAFRA COSMETICS INTERNATIONAL ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15 g/100g N 20181231 68828-053_c9b75af0-88ad-4d3c-a1e7-b35345162e40 68828-053 HUMAN OTC DRUG JAFRA DAILY POWDER FRESH FOR WOMEN ALUMINUM CHLOROHYDRATE LOTION TOPICAL 20120424 OTC MONOGRAPH FINAL part350 JAFRA COSMETICS INTERNATIONAL ALUMINUM CHLOROHYDRATE 12.3 g/100g N 20181231 68828-054_0f9997cc-6ace-4e05-aaa1-c6d659ebb79d 68828-054 HUMAN OTC DRUG FACE PROTECTOR SPF 40 OCTINOXATE OXYBENZONE OCTISALATE OCTOCRYLENE TITANIUM DIOXIDE LOTION TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 7.5; 2; 5; 2; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-055_9cbcd855-2de2-48c1-b4b7-143d94ba9a6c 68828-055 HUMAN OTC DRUG CALMING DYNAMICS SPF 15 OCTINOXATE OCTISALATE OXYBENZONE CREAM TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 7; 4; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-057_77df7252-0230-4020-95a8-3616fe7a25e0 68828-057 HUMAN OTC DRUG 2 IN 1 POWDER MAKE-UP SPF 15 OCTINOXATE TITANIUM DIOXIDE POWDER TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; TITANIUM DIOXIDE 5; 3.25 g/100g; g/100g N 20181231 68828-059_f908b859-c350-4b06-8e86-cabe83cc1e39 68828-059 HUMAN OTC DRUG Cafe Mocha Always Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130225 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-060_714465bd-2186-4e99-9fb7-4eb6c509b56e 68828-060 HUMAN OTC DRUG TENDER MOMENTS SPF 45 HOMOSALATE OCTINOXATE OCTISALATE OXYBENZONE TITANIUM DIOXIDE OCTOCRYLENE LOTION TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE; OXYBENZONE 10; 7.7; 5; 1.5; 5.5; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-061_0176ac8a-911b-4b73-9581-334e92be335a 68828-061 HUMAN OTC DRUG Cashmere Always Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, TItanium Dioxide LIQUID TOPICAL 20130226 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-062_3c9bb4a7-14c1-45e2-af9c-1b1863093f31 68828-062 HUMAN OTC DRUG Cocoa Always Color Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130226 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-064_45b4c3c2-a20c-4f94-969b-0c8d1de34dc5 68828-064 HUMAN OTC DRUG Golden Tan Always Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130227 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-065_d4633a3b-6c9a-4ac8-8db9-497cc48b17c2 68828-065 HUMAN OTC DRUG Ivory Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-066_ec09c2fe-dafe-4c72-a90a-c213ec5bf6b7 68828-066 HUMAN OTC DRUG Natural Tan Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-067_2195dc81-3dec-457c-865c-88c8863c83b9 68828-067 HUMAN OTC DRUG Porcelain Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-068_4d72a003-b164-4d35-be98-a24bf5bca236 68828-068 HUMAN OTC DRUG Quiet Rose Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-069_34e863a4-b18d-4dad-ba6d-4f3d15c24b38 68828-069 HUMAN OTC DRUG Sandy Beige Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-070_1300837e-e4f2-4f28-8074-9a06f5588e2f 68828-070 HUMAN OTC DRUG True Beige Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMethoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-072_dc7c63bb-dc21-4584-bc77-e07dcc78c8c2 68828-072 HUMAN OTC DRUG Beauty Dynamics SPF 15 Daily Eye Treatment Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20120518 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 1.75 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 68828-075_40c5674b-eebd-4344-812a-d5047975d827 68828-075 HUMAN OTC DRUG Bisque Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMethoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-076_6225d5ff-50f7-4904-8f02-518247fb3f81 68828-076 HUMAN OTC DRUG Ivory Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-077_1bf948ae-672c-4a0d-9adc-eee79243e000 68828-077 HUMAN OTC DRUG Quiet Rose Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-078_cc31d229-ded0-4bbb-9d41-ff3e32168457 68828-078 HUMAN OTC DRUG Simply Beige Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-079_d777e6f4-29ea-4faf-b499-d1eadb19ba8d 68828-079 HUMAN OTC DRUG Sandy Beige Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-080_17b7a8de-d2cc-4900-8f46-178e3bde97eb 68828-080 HUMAN OTC DRUG Desert Beige Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-081_1cbfa5b0-e74a-441e-9b80-aa6ba0db01c9 68828-081 HUMAN OTC DRUG Cashmere Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-082_ae45ed21-758f-43d8-9015-b30a6cf8835a 68828-082 HUMAN OTC DRUG Toast Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-083_ff2f0eb4-333b-4c4f-8c8f-5e6b00c557df 68828-083 HUMAN OTC DRUG Cafe Au Lait Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-084_ac200ea2-3377-4aae-8528-ed661705327a 68828-084 HUMAN OTC DRUG Warm Ginger Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-085_22dad215-e37c-41aa-896a-91816bb1342e 68828-085 HUMAN OTC DRUG Toffee Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-086_586b21fb-d87e-4846-a302-1e0ab7896e1f 68828-086 HUMAN OTC DRUG Golden Tan Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-087_40337664-4115-4e92-a93b-a81e8f14b248 68828-087 HUMAN OTC DRUG Natural Tan Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-088_8b9a31fd-87d6-453e-b7ec-a9615a22054b 68828-088 HUMAN OTC DRUG Cafe Mocha Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-089_594d6df9-17e2-4a6e-a3a5-43e5f25e7c29 68828-089 HUMAN OTC DRUG Cocoa Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-090_24912ca5-119f-450e-9b78-d49e5a964322 68828-090 HUMAN OTC DRUG Soft Beige Always Color Stay-On Makeup SPF 10 Titanium Dioxide, Octinoxate/EthylhexylMehtoxycinnamate LOTION TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 8; 2.5 mL/100mL; mL/100mL N 20181231 68828-091_0e9a4398-3df5-4534-8262-2280aae07698 68828-091 HUMAN OTC DRUG Brightening Hand Broad Spectrum SPF 20 Jafra avobenzone, octinoxate, octisalate, octocrylene CREAM TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 7.5; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-092_20684ed5-35c3-4aaf-a2a5-1be32741fc6b 68828-092 HUMAN OTC DRUG Face and Body Sunscreen Spray SPF 35 Homosalate, Oxybenzone, Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20120605 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc HOMOSALATE; OCTINOXATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE 10; 3; 6; 5; 2.79 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 68828-093_f91b8df2-4121-44f0-9d79-221964a725ba 68828-093 HUMAN OTC DRUG Three step hand care Day Care SPF 15 Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 4; 2 mL/100mL; mL/100mL; mL/100mL N 20181231 68828-094_da9804f0-f5ec-4678-85ac-7a6d3c2811b7 68828-094 HUMAN OTC DRUG Sunscreen SPF 30 Jafra Sun Homosalate, Octisalate, Octocrylene, Oxybenzone, Avobenzone CREAM TOPICAL 20120531 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 7.5; 5; 4; 3; 2.79 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 68828-095_bb2d966a-0438-4027-85c2-e2df71a16dc8 68828-095 HUMAN OTC DRUG Tender Moments Baby Bottom Balm Zinc Oxide, Dimethicone CREAM TOPICAL 20120607 OTC MONOGRAPH NOT FINAL part347 JAFRA COSMETICS INTERNATIONAL ZINC OXIDE; DIMETHICONE 10; 2 mL/100mL; mL/100mL N 20181231 68828-096_2a61837c-f8dd-45a2-88d1-6e420eabe96e 68828-096 HUMAN OTC DRUG Foaming Cleanser Jafra Salicylic Acid GEL TOPICAL 20120515 OTC MONOGRAPH FINAL part333D JAFRA COSMETICS INTERNATIONAL SALICYLIC ACID .5 g/100mL N 20181231 68828-097_24878110-604c-4327-9ede-40e16eedcd9a 68828-097 HUMAN OTC DRUG Protector SPF 15 Jafra Sun Avobenzone, Homosalate, Octisalate, Oxybenzone STICK TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2.5; 7.5; 2; 5 g/100g; g/100g; g/100g; g/100g N 20181231 68828-098_bf3b0d26-ca18-4563-821b-86c469f5c24b 68828-098 HUMAN OTC DRUG Time Dynamics Time Protector Daily Defense SPF 15 Octinoxate, Zinc Oxide CREAM, AUGMENTED TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; ZINC OXIDE 3.75; 1.5 mL/50mL; mL/50mL N 20181231 68828-100_4f655bf0-349f-4783-ade0-5b88120654f6 68828-100 HUMAN OTC DRUG Men Dynamics Double Duty Face Protector SPF 15 Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 5.625; 3.75; 1.5 mL/75mL; mL/75mL; mL/75mL N 20181231 68828-101_d39adcf6-9f3d-42a9-907b-c89de9cebd39 68828-101 HUMAN OTC DRUG Jafra Brightening Brightening SPF 15 Otinoxate, Zinc Oxide LOTION TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; ZINC OXIDE 2.5; 2 mL/50mL; mL/50mL N 20181231 68828-102_761c3301-a69f-4521-9aa2-555a9e567ed1 68828-102 HUMAN OTC DRUG Mattifying Tonic Jafra Salicylic Acid LIQUID TOPICAL 20120619 OTC MONOGRAPH FINAL part333D JAFRA COSMETICS INTERNATIONAL SALICYLIC ACID .5 g/100mL N 20181231 68828-103_08e90f7b-714b-4cdb-a88e-0bf886af1bf3 68828-103 HUMAN OTC DRUG Active Sport Family Sunscreen SPF 35 Octinoxate, Octisalate, Avobenzone, Octocrylene CREAM TOPICAL 20120515 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 9.375; 6.25; 2.5; 1.875 mL/125mL; mL/125mL; mL/125mL; mL/125mL N 20181231 68828-104_d510046d-f6c1-48d4-9062-23b2a449873b 68828-104 HUMAN OTC DRUG Clear Pore Clarifier Matte Dynamics Salicylic Acid GEL TOPICAL 20120605 OTC MONOGRAPH FINAL part333D Jafra Cosmetics International Inc SALICYLIC ACID 1 g/100mL N 20181231 68828-105_4f85b3fe-4b3e-4d1c-975d-f62af753a8d0 68828-105 HUMAN OTC DRUG Oil Control testers SPF 15 Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20120605 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 4.8; 2.4; 1.6 mL/80mL; mL/80mL; mL/80mL N 20181231 68828-106_b7139484-a367-449d-b3b5-dcc388d497b8 68828-106 HUMAN PRESCRIPTION DRUG Jafra Always Color Stay-on Makeup SPF 10 Titanium Dioxide, Octinoxate LIQUID TOPICAL 20120730 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc TITANIUM DIOXIDE; OCTINOXATE 6.4; 2 mL/80mL; mL/80mL N 20181231 68828-111_ad22c152-00ea-4fb8-bd10-e749369ed9a5 68828-111 HUMAN OTC DRUG Jafra Pro Avobenzone, Homosalate, Octisalate, Octocrylene KIT TOPICAL 20120730 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc N 20181231 68828-117_437b1a20-4e79-45cb-822b-791b29ca2707 68828-117 HUMAN OTC DRUG Skin Defense Concealer Broad Spectrum SPF 15 Jafra Cosmetics Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-118_321522e8-16cc-40dc-acdf-1aecf0adb572 68828-118 HUMAN OTC DRUG Hand Care Day care Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20121026 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-119_b3330ad8-065f-4d6c-8bbc-d3485443716a 68828-119 HUMAN OTC DRUG Tea Blend Samples Jafra Avobenzone, Octinoxate, Octisalate KIT 20130118 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL N 20181231 68828-124_0b39592e-7915-4932-a0f1-b7598e043f8e 68828-124 HUMAN OTC DRUG Hand Complex Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Oxybenzone JELLY TOPICAL 20130213 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 2 g/75mL; g/75mL; g/75mL; g/75mL N 20181231 68828-125_83df8f52-f366-4cba-9a6d-98bcafea87d7 68828-125 HUMAN OTC DRUG Soft Ivory Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-126_2be4224d-abca-48dc-aa09-5cdd9642245f 68828-126 HUMAN OTC DRUG Soft Beige Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-127_12ce168c-288e-4237-b512-3e10453169cb 68828-127 HUMAN OTC DRUG Toast Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-128_22f886d2-4c43-4fdd-a9cc-45fcbd642d6d 68828-128 HUMAN OTC DRUG Toffee Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-129_5daadac0-815f-4320-befb-d246022433bf 68828-129 HUMAN OTC DRUG Clear Blemish Treatment Jafra Salicylic Acid GEL TOPICAL 20120619 OTC MONOGRAPH FINAL part358H JAFRA COSMETICS INTERNATIONAL SALICYLIC ACID 2 g/151mL N 20181231 68828-130_09d8409f-3809-4a11-84e0-a0b7fdcb4191 68828-130 HUMAN OTC DRUG True Beige Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-131_a2971002-0c1b-45ed-9606-5c11e1854426 68828-131 HUMAN OTC DRUG Daily Defense SPF 15 Jafra Octinoxate, Zinc Oxide CREAM TOPICAL 20120530 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; ZINC OXIDE 7.5; 3 g/100mL; g/100mL N 20181231 68828-132_0ec90acf-e136-4d58-bf64-dd6582911753 68828-132 HUMAN OTC DRUG Broad Spectrum SPF 15 Daily Eye Treat Jafra Avobenzone, Homosalate, Octisalate, Octoorylene CREAM TOPICAL 20130408 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.5; 7.5; 5; 1.75 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-133_d6e1f3aa-ad38-447a-8b5e-0c85b32c23cf 68828-133 HUMAN OTC DRUG Face Lift Broad Spectrum SPF 20 Jafra Pro Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20130415 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-134_c626bcb6-4de0-4eed-bcc4-af251413324e 68828-134 HUMAN OTC DRUG Pure Porcelain Skin Defense Makeup SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-135_c626bcb6-4de0-4eed-bcc4-af251413324e 68828-135 HUMAN OTC DRUG Pure Ivory Skin Defense Makeup SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-136_c626bcb6-4de0-4eed-bcc4-af251413324e 68828-136 HUMAN OTC DRUG Pure Champagne Skin Defense Makeup SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-137_c626bcb6-4de0-4eed-bcc4-af251413324e 68828-137 HUMAN OTC DRUG Pure Tan Skin Defense Makeup SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-138_c626bcb6-4de0-4eed-bcc4-af251413324e 68828-138 HUMAN OTC DRUG Pure Cashmere Skin Defense Makeup SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20130417 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-139_e4dc7528-9efe-4164-97bc-4c772a70a9b5 68828-139 HUMAN OTC DRUG Natural Tan Oil Controlling Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130419 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-140_e4dc7528-9efe-4164-97bc-4c772a70a9b5 68828-140 HUMAN OTC DRUG Ivory Oil Controlling Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130419 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-141_e4dc7528-9efe-4164-97bc-4c772a70a9b5 68828-141 HUMAN OTC DRUG Barely Beige Oil Controlling Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130419 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-142_4cc7bf50-a93d-4223-bb0e-8a020930259b 68828-142 HUMAN OTC DRUG Natural Tan Moisturizing Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130423 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-143_4cc7bf50-a93d-4223-bb0e-8a020930259b 68828-143 HUMAN OTC DRUG Ivory Moisturizing Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130423 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-144_4cc7bf50-a93d-4223-bb0e-8a020930259b 68828-144 HUMAN OTC DRUG Barely Beige Moisturizing Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130423 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-145_4cc7bf50-a93d-4223-bb0e-8a020930259b 68828-145 HUMAN OTC DRUG Cashmere Moisturizing Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone LIQUID TOPICAL 20130423 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-146_097724fb-0dc0-4450-bf94-fa7d6ff42f1b 68828-146 HUMAN OTC DRUG Warm Ginger Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-147_9f38acf2-5ebc-4c2a-83b6-2813563edcc3 68828-147 HUMAN OTC DRUG SKIN DEFENSE MAKEUP SPF-15 OCTINOXATE OCTISALATE OXYBENZONE LOTION TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 6; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-148_d87ff653-9abc-45f2-b8b5-61570538ac8e 68828-148 HUMAN OTC DRUG Bisque Always Color Stay-on Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium dioxide LIQUID TOPICAL 20130221 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-150_3a483673-b894-4efe-9021-5c10cdd637ee 68828-150 HUMAN OTC DRUG BALANCE DYNAMICS BALANCING SPF 15 OCTISALATE OXYBENZONE OCTINOXATE LOTION TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; OXYBENZONE; OCTINOXATE 4; 2; 7 g/100mL; g/100mL; g/100mL N 20181231 68828-154_9d5b3184-9594-40ad-88f8-39a377f6e336 68828-154 HUMAN OTC DRUG Balancing Dynamics Kit Jafra Balancing Dynamics KIT 20121116 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL N 20181231 68828-155_33f8450a-f387-401c-8ed6-cb98a87793cf 68828-155 HUMAN OTC DRUG CALM DYNAMICS GENTLE HYDRATING DAY SPF 15 OCTINOXATE OCTISALATE OXYBENZONE CREAM TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 7; 4; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-156_b3ef9b24-e8b0-4787-a9a4-21aee5a47a48 68828-156 HUMAN OTC DRUG HYDRATION DYNAMICS MOISTURE REPLENISHMENT SPF 15 OCTINOXATE OCTISALATE OXYBENZONE CREAM TOPICAL 20120424 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 6.5; 4; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-158_4913fc30-23a1-463b-9d86-16c39762d979 68828-158 HUMAN OTC DRUG CONTROL DYNAMICS MATTIFYING SPF 15 OCTINOXATE OCTISALATE OXYBENZONE LOTION TOPICAL 20120514 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 7; 4; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-159_dc716edf-ed5d-4977-bcfd-7f273021c969 68828-159 HUMAN OTC DRUG Facial Boosting Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 25; 75; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 68828-160_a8a781de-d2c9-4a3f-99ec-6f1053197410 68828-160 HUMAN OTC DRUG Tea Blend Daily Moisturizer SPF 15 Jafra Avobenzone, Octinoxate, Octisalate CREAM TOPICAL 20120312 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE 2.5; 7.5; 5 g/100mL; g/100mL; g/100mL N 20181231 68828-161_a06fb75e-f5c0-4823-ae22-598895b4dbb4 68828-161 HUMAN OTC DRUG Double Duty Face Protector SPF 15 Jafra Octinoxate, Octisalate, Zinc Oxide LOTION TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 2.9 g/100mL; g/100mL; g/100mL N 20181231 68828-162_3c87fec9-444d-4427-a2c8-28fd80bc1540 68828-162 HUMAN OTC DRUG Sunscreen SPF 30 Jafra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20121204 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.79; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-163_471ec4a3-3e85-4fce-be2d-b2dbdadd35d7 68828-163 HUMAN OTC DRUG HARMONY DYNAMICS FACIAL BOOSTING SPF 15 OCTINOXATE OCTISALATE OXYBENZONE CREAM TOPICAL 20120419 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OCTISALATE; OXYBENZONE 7; 4; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-164_45815c73-2e38-4d98-9087-da2d1ffb4215 68828-164 HUMAN OTC DRUG Always Color Stay on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20121126 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 7.3 g/100mL; g/100mL; g/100mL N 20181231 68828-165_4f7c7ed5-3c4a-4e6e-b3d0-c82ba290a7c9 68828-165 HUMAN OTC DRUG Sunscreen Broad Spectrum SPF 50 Jafra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20130219 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 10; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-166_1e447ef1-a385-4cb7-8907-b8e3d491b4fd 68828-166 HUMAN OTC DRUG Face and Body Sunscreen SPF 35 Jafra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20130110 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.79; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-167_00a13542-f01a-42a6-9ab3-f790e11e07f3 68828-167 HUMAN OTC DRUG Face Protector Broad Spectrum SPF 40 Jafra Octinoxate, Octisalate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 5; 1.5; 2; 4.25; 2.9 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-168_46d49ac8-2bc8-4402-81ae-542c481727fe 68828-168 HUMAN OTC DRUG Cafe au lait Always Stay-on Makeup Broad Spectrum SPF 15 Jafra octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130222 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-169_02e486a3-ba31-4e14-8eab-16f2622c4e31 68828-169 HUMAN OTC DRUG SImply Beige Always color stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-170_01f08eca-09b6-4916-96f2-822cf41a8e03 68828-170 HUMAN OTC DRUG Light Skin Defense Concealer Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-171_01f08eca-09b6-4916-96f2-822cf41a8e03 68828-171 HUMAN OTC DRUG Medium Skin Defense Concealer Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-172_01f08eca-09b6-4916-96f2-822cf41a8e03 68828-172 HUMAN OTC DRUG Dark Skin Defense Concealer Broad Spectrum SPF 15 Jafra Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20130522 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OCTISALATE; OXYBENZONE 7; 3; 2 g/100mL; g/100mL; g/100mL N 20181231 68828-173_2cffc2ae-a29e-4c51-921a-924469c5f053 68828-173 HUMAN OTC DRUG Desert Beige Always Stay-on Makeup SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide LIQUID TOPICAL 20130227 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International Inc OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.1 g/100mL; g/100mL; g/100mL N 20181231 68828-174_12b10ce1-0d84-41b2-b4f6-7d154bf14708 68828-174 HUMAN OTC DRUG BeCause Antibacterial Hand Jafra Ethyl Alcohol GEL TOPICAL 20130730 OTC MONOGRAPH NOT FINAL part333E Jafra Cosmetics International Inc ALCOHOL 62 g/100mL N 20181231 68828-175_a51d62e3-72a6-4b77-95f6-04597ca9597e 68828-175 HUMAN OTC DRUG BeCause Antibacterial Hand Jafra Triclosan CREAM TOPICAL 20130731 OTC MONOGRAPH NOT FINAL part333A Jafra Cosmetics International Inc TRICLOSAN .3 g/100mL N 20181231 68828-177_82304d10-ab20-41ce-91c5-9f412d777084 68828-177 HUMAN OTC DRUG Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Jafra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LIQUID TOPICAL 20130930 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 7; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-178_3c7865ef-2d2d-4a32-a7f7-739f170f204c 68828-178 HUMAN OTC DRUG Balancing Day Moisture Broad Spectrum SPF 15 Jafra Avobenzone,Octinoxate, Octisalate, Octisalate, Oxybenzone CREAM TOPICAL 20131028 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.75; 7.5; 5; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-179_fc4a5bf0-8e8b-45d8-b6f8-4a2c6b6f50b7 68828-179 HUMAN OTC DRUG Hydrating day moisture broad spectrum SPF15 Jafra Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20131125 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.5; 6.5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-180_41f21db1-3d44-47d6-a308-b74258017f35 68828-180 HUMAN OTC DRUG Mattifying Day Moisture Broad Spectrum SPF 15 Jafra Avobenzone, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20131126 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.75; 5; 7.5; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-181_9f2b18c2-f0b9-45f5-ac7d-ed0073e80215 68828-181 HUMAN OTC DRUG Advanced Dynamics Soothing day Moisture Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Octocrylene, oxybenzone CREAM TOPICAL 20131126 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 6.5; 4; 2.75; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-182_8e2b8f94-bea8-4f14-a7fb-1a4d322ba397 68828-182 HUMAN OTC DRUG Balancing Day Moisture Broad Spectrum SPF 15 Jafra Avobenzone,Octinoxate, Octisalate, Octisalate, Oxybenzone CREAM TOPICAL 20131028 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.75; 7.5; 5; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-183_6ca921a3-a09e-49c3-9d7a-08f4dc5a0992 68828-183 HUMAN OTC DRUG Tawny Beige Always Color Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20131212 OTC MONOGRAPH FINAL part352 Jafra Cosmetics international OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.29 g/100mL; g/100mL; g/100mL N 20181231 68828-184_16316d05-823f-42d1-8516-a1529a9f2107 68828-184 HUMAN OTC DRUG Sienna Always Color Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20131212 OTC MONOGRAPH FINAL part352 Jafra Cosmetics international OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.29 g/100mL; g/100mL; g/100mL N 20181231 68828-185_3653cf60-d5c1-41a0-ab3e-53956e8f7344 68828-185 HUMAN OTC DRUG Warm Honey Always Color Stay-on Makeup Broad Spectrum SPF 15 Jafra Octinoxate, Oxybenzone, Titanium Dioxide CREAM TOPICAL 20131212 OTC MONOGRAPH FINAL part352 Jafra Cosmetics international OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 5; 2; 2.29 g/100mL; g/100mL; g/100mL N 20181231 68828-186_0542540e-ba6b-4a58-9bee-cb9b9c654d75 68828-186 HUMAN OTC DRUG Ships Ahoy Seashore Sunscreen Broad Spectrum SPF 30 Jafra Avobenzone, Homosalate,Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20140224 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.79; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-187_a0c694ec-7006-42e1-a77c-35eaa4a0fe97 68828-187 HUMAN OTC DRUG Sun Broad Spectrum SPF 30 Jafra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20140226 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.79; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-188_3f0ae898-5c55-4513-9303-4c2d1a1328ab 68828-188 HUMAN OTC DRUG Sun Face Protector Sunscreen Broad Spectrum SPF 50 Jafra Avobenzone, Homosalate, Octisalate,Octocrylene, Oxybenzone LOTION TOPICAL 20140227 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 10; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-190_720cb22b-5b7c-49df-a8ae-f4bdfcf4bebc 68828-190 HUMAN OTC DRUG CC Cream Complexion Corrector Light Medium Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20140303 OTC MONOGRAPH FINAL part352 Jafra cosmetics International AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 5; 4; 1.8 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-191_b74fd82f-a434-402f-96e8-21457c43d3f8 68828-191 HUMAN OTC DRUG CC Cream Complexion Corrector Medium Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20140303 OTC MONOGRAPH FINAL part352 Jafra cosmetics International AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 5; 4; 1.8 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-192_76b8b357-aeea-4252-b63b-625f03ee5b5c 68828-192 HUMAN OTC DRUG CC Cream Complexion Corrector Medium Dark Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20140303 OTC MONOGRAPH FINAL part352 Jafra cosmetics International AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 5; 4; 1.8 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-193_69747210-d7ce-41bf-ab33-8bb7d96172ac 68828-193 HUMAN OTC DRUG CC Cream Complexion Corrector Dark Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20140303 OTC MONOGRAPH FINAL part352 Jafra cosmetics International AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 2; 5; 4; 1.8 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-194_5004376e-cc15-4ce1-880e-41019a7ad329 68828-194 HUMAN OTC DRUG Skin Balancing Makeup Broad Spectrum SPF 20 Jafra Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part352 Jafra Cosmetics AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 6; 4; 2.7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-197_fee5bf5c-bb6d-4d47-a155-eab47470a7eb 68828-197 HUMAN OTC DRUG Sensitive Skin antiperspirant deodorant roll-on Jafra Daily Aluminum Chlorohydrate LIQUID TOPICAL 20140902 OTC MONOGRAPH FINAL part350 Jafra cosmetics International ALUMINUM CHLOROHYDRATE 12.3 g/100mL N 20181231 68828-198_a220fce8-5d5e-407b-937e-108253d71303 68828-198 HUMAN OTC DRUG Antiperspirant Deodorant Roll-on Jafra Daily Aluminum Chlorohydrate LIQUID TOPICAL 20140814 OTC MONOGRAPH FINAL part350 Jafra cosmetics International ALUMINUM CHLOROHYDRATE 12.3 g/100mL N 20181231 68828-199_f2fc3dbb-1ed9-4eec-940e-ef009f6f31f3 68828-199 HUMAN OTC DRUG Skin brightening antiperspirant deodorant roll-on Jafra Daily Aluminum Chlorohydrate LIQUID TOPICAL 20140903 OTC MONOGRAPH FINAL part350 Jafra cosmetics International ALUMINUM CHLOROHYDRATE 12.3 g/100mL N 20181231 68828-200_d7f34951-c81a-42ed-b1c7-04830fd637ea 68828-200 HUMAN OTC DRUG hair minimizing antiperspirant deodorant roll-on Jafra Daily Aluminum Chlorohydrate LIQUID TOPICAL 20140904 OTC MONOGRAPH FINAL part350 Jafra cosmetics International ALUMINUM CHLOROHYDRATE 100 g/100mL N 20181231 68828-201_b823ff10-571b-40ac-bb79-470b7256f971 68828-201 HUMAN OTC DRUG defy time protector moisturizer broad spectrum SPF 15 Jafra time dynamics Octinoxate, Zinc Oxide CREAM TOPICAL 20141125 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International OCTINOXATE; ZINC OXIDE 7.5; 3 g/100mL; g/100mL N 20181231 68828-202_779eb2d2-a312-4349-baf0-01e762cc8e6b 68828-202 HUMAN OTC DRUG recover skin boosting moisturizer broad spectrum SPF 15 Jafra gold dynamics Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 2.5; 7.5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-203_c33a3a03-1d82-4f74-97d5-4536d9fd27e7 68828-203 HUMAN OTC DRUG Brightening Dynamics Traveling Kit Jafra Octinoxate, Zinc Oxide KIT 20141214 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc N 20181231 68828-204_f30d1e4c-42bd-4cc2-911d-cee2d955a584 68828-204 HUMAN OTC DRUG Pastel Antiperspirant Deodorant Roll-On Jafra Aluminum Chlorohydrate LIQUID TOPICAL 20141217 OTC MONOGRAPH FINAL part350 Jafra Cosmetics International Inc ALUMINUM CHLOROHYDRATE 12.3 g/100mL N 20181231 68828-205_5fb90406-f458-413a-8d4e-673525c51810 68828-205 HUMAN OTC DRUG Gold Dynamics Travel Kit Jafra Avobenzone, Oxtinoxate, Octisalate, Oxybenzone KIT 20141214 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc N 20181231 68828-209_7c1b50fb-e088-4b95-81f6-85032f06d01d 68828-209 HUMAN OTC DRUG Time Dynamics Travel Kit Jafra Octinoxate, Zinc Oxide KIT 20141130 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International Inc N 20181231 68828-215_8009be86-8816-44a7-a0ad-18b053b3b721 68828-215 HUMAN OTC DRUG Oil-Free Facial Sunscreen Spectrum SPF 50 JAFRA Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20150213 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 68828-216_19688847-b72e-457b-bb27-9c84f1e324cf 68828-216 HUMAN OTC DRUG Antiperspirant Deodorant Roll-On Jafra le moire Aluminum Chlorohydrate LIQUID TOPICAL 20150407 OTC MONOGRAPH FINAL part350 Jafra Cosmetics International ALUMINUM CHLOROHYDRATE 12.3 g/100mL N 20181231 68828-217_d288e1d5-7ef1-4ec2-bb14-68946d38c461 68828-217 HUMAN OTC DRUG Vesen Antiperpirant Deodorant Roll-On JAFRA Aluminum Chlorohydrate STICK TOPICAL 20150407 OTC MONOGRAPH FINAL part350 Jafra Cosmetics International Inc ALUMINUM CHLOROHYDRATE 12.3 g/12.3mL N 20181231 68828-225_46fde133-fb8d-423d-9b74-375d8a300469 68828-225 HUMAN OTC DRUG Jafra Long Wear Makeup Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-226_b26cc063-e9cb-4146-aba1-f1f3a04d20de 68828-226 HUMAN OTC DRUG Jafra Long Wear Makeup Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-227_16db4660-da02-443a-bf61-feb720844653 68828-227 HUMAN OTC DRUG Jafra Long Wear Makeup Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-228_6e781d24-eecf-48b1-b1df-48fd61b286d4 68828-228 HUMAN OTC DRUG Jafra Long Wear Makeup Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-229_6d1917f6-daa9-4283-a9fe-5e81a15aa774 68828-229 HUMAN OTC DRUG Jafra Long Wear Makeup Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-230_6267d728-3796-4feb-b845-40036e981a7d 68828-230 HUMAN OTC DRUG Jafra Long Wear Makeup Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-231_0db7ac33-a919-46c3-9bc8-7f95370e92fb 68828-231 HUMAN OTC DRUG Jafra Long Wear Makeup Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-232_7a5cd838-05e4-46ff-8dbc-d8efc528bf3d 68828-232 HUMAN OTC DRUG Jafra Long Wear Makeup Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-233_2c37c3a0-fb3d-42d4-b0ea-75aff6da9a5f 68828-233 HUMAN OTC DRUG Jafra Long Wear Makeup Testers Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-234_7953aa9b-39ff-4a67-98c7-b42c3005d8c4 68828-234 HUMAN OTC DRUG Cappuccino Long Wear Makeup Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-235_9b4e5703-a4e4-4284-916b-4117c4136556 68828-235 HUMAN OTC DRUG Light CC creme Broad Spectrum SPF 15 JAFRA Zinc Oxide CREAM TOPICAL 20150713 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International ZINC OXIDE 6.8 g/100mL N 20181231 68828-236_22de52ae-b427-4fc7-b808-744ba1317819 68828-236 HUMAN OTC DRUG MediumCC creme Broad Spectrum SPF 15 JAFRA Zinc Oxide CREAM TOPICAL 20150713 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International ZINC OXIDE 6.8 g/100mL N 20181231 68828-237_6075ecfa-4130-4161-9b4d-15554dc29a14 68828-237 HUMAN OTC DRUG Dark CC creme Broad Spectrum SPF 15 JAFRA Zinc Oxide CREAM TOPICAL 20150713 OTC MONOGRAPH FINAL part352 Jafra Cosmetics International ZINC OXIDE 6.8 g/100mL N 20181231 68828-240_884eb727-dd41-4293-badc-55ec8904af1a 68828-240 HUMAN OTC DRUG Solar Protection Fluid Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20150810 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 68828-241_b4d4da34-ee85-4ab5-87e1-73d308536a9a 68828-241 HUMAN OTC DRUG CC Creme Concealer Broad Spectrum SPF 20 Jafra Avobenzone, Homosalate, Octisalate, Octocrylene CREAM TOPICAL 20150811 OTC MONOGRAPH NOT FINAL part352 Jafra Cosmetics International AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 5; 7 g/100g; g/100g; g/100g; g/100g N 20181231 68828-242_74143c86-09d4-407e-aa6f-3ffd4f90d440 68828-242 HUMAN OTC DRUG Royal Jelly Kit Jafra Avobenzone, Homosalate, Octisalate, Octocrylene KIT 20150813 OTC MONOGRAPH NOT FINAL part352 JAFRA COSMETICS INTERNATIONAL N 20181231 68828-250_1319b145-7398-4981-9ee9-3c386086893e 68828-250 HUMAN OTC DRUG Radiance Foundation Broad Spectrum SPF 20 - Bare JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-251_c1369da9-f235-4857-ad55-7786ca255a80 68828-251 HUMAN OTC DRUG Radiance Foundation Broad Spectrum SPF 20 - Bronze JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-252_34203838-ebd2-4357-9732-8d52a6449af7 68828-252 HUMAN OTC DRUG Radiance Foundation Broad Spectrum SPF 20 - Fair JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-253_44f14316-3f3b-407c-b79e-89b8b34c7f2b 68828-253 HUMAN OTC DRUG Radiance Foundation Broad Spectrum SPF 20 - Honey JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-254_ab336ac1-128c-432f-85b3-d6baeb891266 68828-254 HUMAN OTC DRUG Radiance Foundation Broad Spectrum SPF 20 - Natural JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-255_7b663f6d-03bc-4a5c-b32f-e70dc7eb1938 68828-255 HUMAN OTC DRUG Radiance Foundation Broad Spectrum SPF 20 - Nude JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-256_da502014-a201-41ba-91f1-421fe42a221e 68828-256 HUMAN OTC DRUG Radiance Foundation Broad Spectrum SPF 20 - Spicy JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-257_163cf835-d14d-46da-8297-824a180a8b7e 68828-257 HUMAN OTC DRUG Radiance Foundation Broad Spectrum SPF 20 - Tawny JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-258_31c531e0-8f71-42b3-a761-e40ef2cdc005 68828-258 HUMAN OTC DRUG Radiance Foundation Broad Spectrum SPF 20 - Tawny JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-259_d4aae331-0f25-4e39-bf1c-16c0af560e51 68828-259 HUMAN OTC DRUG Caramel Radiance Foundation Broad Spectrum SPF 20 - Tawny JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-260_76535126-4bdb-4c9c-af3e-b42d37288e6a 68828-260 HUMAN OTC DRUG Sable Radiance Foundation Broad Spectrum SPF 20 - Tawny JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-261_cc4008b6-950f-46d2-9481-5fb645b3850e 68828-261 HUMAN OTC DRUG Cappuccino Radiance Foundation Broad Spectrum SPF 20 - Tawny JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-262_557a2558-f18b-42cf-ad4e-ed3a73c13083 68828-262 HUMAN OTC DRUG Earth Radiance Foundation Broad Spectrum SPF 20 - Tawny JAFRA Octinoxate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTINOXATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-263_801e4d6a-3d66-457f-8e0a-c9608b211161 68828-263 HUMAN OTC DRUG Long Wear Makeup Broad Spectrum SPF 20 Fair Jafra Octisalate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-264_560636ae-b35d-4f1a-82fb-9964006c0b12 68828-264 HUMAN OTC DRUG Long Wear Makeup Broad Spectrum SPF 20 Bare Jafra Octisalate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-265_b18ad93f-3cdd-437b-bb72-1dbca2cc89b9 68828-265 HUMAN OTC DRUG Long Wear Makeup Broad Spectrum SPF 20 Bronze Jafra Octisalate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-267_75c3f22d-25de-4b9a-8061-34577fe229a2 68828-267 HUMAN OTC DRUG Long Wear Makeup Broad Spectrum SPF 20 Natural Jafra Octisalate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-269_5284f59f-172d-4e1b-8b4a-47385baab351 68828-269 HUMAN OTC DRUG Long Wear Makeup Broad Spectrum SPF 20 Spice Jafra Octisalate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-270_6d1899f4-0190-49b9-a33e-d4a6ef3d033c 68828-270 HUMAN OTC DRUG Long Wear Makeup Broad Spectrum SPF 20 Tawny Jafra Octisalate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-271_84e92c59-cbfe-46bd-8870-c8d53da27637 68828-271 HUMAN OTC DRUG Long Wear Makeup Broad Spectrum SPF 20 Cappuccino Jafra Octisalate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-272_9b11ef13-eea4-459b-8c1d-fa6ceca0890b 68828-272 HUMAN OTC DRUG Long Wear Makeup Broad Spectrum SPF 20 Caramel Jafra Octisalate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-273_6343a42a-d523-4747-8a33-0d7319fb2037 68828-273 HUMAN OTC DRUG Long Wear Makeup Broad Spectrum SPF 20 Earth Jafra Octisalate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-274_f142147f-16cb-49d6-9181-d38606633941 68828-274 HUMAN OTC DRUG Long Wear Makeup Broad Spectrum SPF 20 Sable Jafra Octisalate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-275_5beabe27-7c91-4057-a89c-8d72ac67f4a6 68828-275 HUMAN OTC DRUG Long Wear Makeup Broad Spectrum SPF 20 Nude Jafra Octisalate, Zinc Oxide CREAM TOPICAL 20170221 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.8 g/100mL; g/100mL N 20181231 68828-278_c0ba7bbf-5ae7-4f2c-b88f-1d9f8fc1f2d3 68828-278 HUMAN OTC DRUG Berry Powerful Lip Care Dimethicone JELLY TOPICAL 20171013 OTC MONOGRAPH FINAL part347 JAFRA COSMETICS INTERNATIONA DIMETHICONE 2 g/100g N 20181231 68828-335_032a5229-c00d-482b-954d-81f083f02754 68828-335 HUMAN OTC DRUG Caramel Long Wear Makeup Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-336_f943f47b-51b7-4bb7-8de2-c72c2963b9f5 68828-336 HUMAN OTC DRUG Earth Long Wear Makeup Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-337_918a0cb4-0153-456a-b8a7-9201bfabe66a 68828-337 HUMAN OTC DRUG Sable Long Wear Makeup Broad Spectrum SPF 20 Octisalate, Zinc Oxide CREAM TOPICAL 20150707 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL OCTISALATE; ZINC OXIDE 3; 6.82 g/100mL; g/100mL N 20181231 68828-400_cd79318c-5b0d-4663-8cfa-a79c6db0a80b 68828-400 HUMAN OTC DRUG Day Care for Hands Broad Spectrum SPF 15 Jafra Avobenzone, Octinoxate, Octisalate, Oxybenzone CREAM TOPICAL 20160614 OTC MONOGRAPH FINAL part352 JAFRA COSMETICS INTERNATIONAL AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 4; 2 g/75mL; g/75mL; g/75mL; g/75mL N 20181231 68828-401_41941041-54cd-40c8-8483-eaf59a867d85 68828-401 HUMAN OTC DRUG Royal Jelly Scar Jafra Dimethicone CREAM TOPICAL 20170127 OTC MONOGRAPH FINAL part347 Jafra Cosmetics International Inc DIMETHICONE 2 g/100mL N 20181231 68848-001_578120ea-8e99-4f6d-9737-bf5251a10288 68848-001 HUMAN OTC DRUG Topical Anesthetic Anorectal Cream Numb and Number Lidocaine CREAM TOPICAL 20160811 OTC MONOGRAPH FINAL part346 Dermtech Labs Inc. dba GD Labs LIDOCAINE 5 g/100g N 20181231 68850-004_f8939d3c-f0f7-4fb3-baf6-6b150c426f50 68850-004 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20061215 NDA AUTHORIZED GENERIC NDA016320 STI Pharma ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] E 20171231 68850-005_f8939d3c-f0f7-4fb3-baf6-6b150c426f50 68850-005 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20061215 NDA AUTHORIZED GENERIC NDA016320 STI Pharma ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] E 20171231 68850-010_1af4db6d-a908-49f8-b2aa-dc73796d03af 68850-010 HUMAN PRESCRIPTION DRUG Myambutol Ethambutol hydrochloride TABLET, FILM COATED ORAL 20070810 NDA NDA016320 STI Pharma, LLC ETHAMBUTOL HYDROCHLORIDE 100 mg/1 Antimycobacterial [EPC] N 20181231 68850-012_1af4db6d-a908-49f8-b2aa-dc73796d03af 68850-012 HUMAN PRESCRIPTION DRUG Myambutol Ethambutol hydrochloride TABLET, FILM COATED ORAL 20070810 NDA NDA016320 STI Pharma, LLC ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] N 20181231 68852-7777_7003bd4f-4d67-4de9-b18e-a0946ebe0844 68852-7777 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN COMPRESSED GAS RESPIRATORY (INHALATION) 20041010 UNAPPROVED MEDICAL GAS Wolf Industries dba Grace Healthcare, Inc OXYGEN 99 L/100L N 20181231 68852-7778_7003bd4f-4d67-4de9-b18e-a0946ebe0844 68852-7778 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20040801 UNAPPROVED MEDICAL GAS Wolf Industries dba Grace Healthcare, Inc OXYGEN 99 L/100L N 20181231 68858-100_d41de66f-5264-40f0-80e1-753964e9a67b 68858-100 HUMAN OTC DRUG MAZON MEDICATED PSORIASIS COAL TAR CREAM TOPICAL 20101101 OTC MONOGRAPH FINAL part358H Advantage Sales and Marketing COAL TAR .55 g/100g N 20181231 68875-0101_718ce754-32c4-4ae7-87b9-50465bc5bcd7 68875-0101 HUMAN PRESCRIPTION DRUG Gattex teduglutide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20121221 NDA NDA203441 Shire-NPS Pharmaceuticals, Inc. TEDUGLUTIDE 5 mg/.5mL GLP-2 Analog [EPC],Glucagon-like Peptide-2 (GLP-2) Agonists [MoA],Glucagon-Like Peptide 2 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 68875-0102_718ce754-32c4-4ae7-87b9-50465bc5bcd7 68875-0102 HUMAN PRESCRIPTION DRUG Gattex teduglutide KIT 20121221 NDA NDA203441 Shire-NPS Pharmaceuticals, Inc. N 20181231 68875-0103_718ce754-32c4-4ae7-87b9-50465bc5bcd7 68875-0103 HUMAN PRESCRIPTION DRUG Gattex teduglutide KIT 20121221 NDA NDA203441 Shire-NPS Pharmaceuticals, Inc. N 20181231 68875-0202_78d69ddf-b942-45cb-adc1-e0c09fff3093 68875-0202 HUMAN PRESCRIPTION DRUG NATPARA (parathyroid hormone) PARATHYROID HORMONE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20150123 BLA BLA125511 Shire-NPS Pharmaceuticals, Inc. PARATHYROID HORMONE 25 ug/.08mL Parathyroid Hormone [Chemical/Ingredient],Parathyroid Hormone [EPC] N 20181231 68875-0203_78d69ddf-b942-45cb-adc1-e0c09fff3093 68875-0203 HUMAN PRESCRIPTION DRUG NATPARA (parathyroid hormone) PARATHYROID HORMONE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20150123 BLA BLA125511 Shire-NPS Pharmaceuticals, Inc. PARATHYROID HORMONE 50 ug/.08mL Parathyroid Hormone [Chemical/Ingredient],Parathyroid Hormone [EPC] N 20181231 68875-0204_78d69ddf-b942-45cb-adc1-e0c09fff3093 68875-0204 HUMAN PRESCRIPTION DRUG NATPARA (parathyroid hormone) PARATHYROID HORMONE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20150123 BLA BLA125511 Shire-NPS Pharmaceuticals, Inc. PARATHYROID HORMONE 75 ug/.08mL Parathyroid Hormone [Chemical/Ingredient],Parathyroid Hormone [EPC] N 20181231 68875-0205_78d69ddf-b942-45cb-adc1-e0c09fff3093 68875-0205 HUMAN PRESCRIPTION DRUG NATPARA (parathyroid hormone) PARATHYROID HORMONE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20150123 BLA BLA125511 Shire-NPS Pharmaceuticals, Inc. PARATHYROID HORMONE 100 ug/.08mL Parathyroid Hormone [Chemical/Ingredient],Parathyroid Hormone [EPC] N 20181231 68877-001_ad2f56c6-1f78-4493-9b08-03e3248afda4 68877-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040525 NDA NDA205849 United States Cylinder Gas Corporation OXYGEN 990 mL/L N 20181231 68877-002_fa5c0752-2f29-46b1-8944-9603fdb9ce5b 68877-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20101010 NDA NDA205850 United States Cylinder Gas Corporation NITROGEN 900 mL/L N 20181231 68878-118_4c10210c-8cff-4931-a507-bb01e8d5003e 68878-118 HUMAN OTC DRUG Theochem Foaming Hand Sanitizer FOAMING HAND SANTIZER LIQUID TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part333E Theochem Laboratories Inc BENZALKONIUM CHLORIDE .1 mg/mL E 20171231 68878-119_518ac54d-fdd1-4eda-ab42-8818bb33d176 68878-119 HUMAN OTC DRUG Foaming Hand Sanitizer Foaming Hand Sanitizer LIQUID TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part333A Theochem Laboratories Inc BENZALKONIUM CHLORIDE .1 mg/mL E 20171231 68878-120_c9a39a32-00de-42f0-ba65-c1ee1ce214ca 68878-120 HUMAN OTC DRUG Theochem Tea Tree Hand and Body Wash Tea Tree Hand and Body Wash SOAP TOPICAL 20040916 OTC MONOGRAPH NOT FINAL part333A Theochem Laboratories TRICLOSAN 2 g/L E 20171231 68878-130_6a1a4089-eb4e-4e37-a968-e99e5eaacd01 68878-130 HUMAN OTC DRUG Theochem White Tea Hand and Body Wash White Tea Hand and Body Wash SOAP TOPICAL 20080110 OTC MONOGRAPH NOT FINAL part333A Theochem Laboratories Inc TRICLOSAN 2 g/L E 20171231 68878-131_8cab5a87-2828-409b-8884-2638198e7758 68878-131 HUMAN OTC DRUG White Tea Antibacterial White Tea Antibacterial SOAP TOPICAL 20081001 OTC MONOGRAPH NOT FINAL part333A Theochem Laboratories, Inc TRICLOSAN .002 g/mL E 20171231 68878-140_32a6f64d-784d-49d0-a5bd-37a5dc5f2420 68878-140 HUMAN OTC DRUG Theochem Tea Tree Hand and Body Wash Tea Tree Hand and Body Wash SOAP TOPICAL 20080923 OTC MONOGRAPH NOT FINAL part333A Theochem Laboratories Inc TRICLOSAN .002 g/mL E 20171231 68878-561_2c659acd-e3e2-455f-b03b-35e327e8d360 68878-561 HUMAN OTC DRUG Theochem Tea Tree Hand and Body Wash Tea Tree Hand and Body Wash SOAP TOPICAL 20170808 OTC MONOGRAPH NOT FINAL part333A Theochem Laboratories BENZALKONIUM CHLORIDE .1 mg/L N 20181231 6889-0312_6f4409a6-8d27-4838-a4ab-15f094dc40e7 6889-0312 HUMAN OTC DRUG Beautipharm All Day Moisturizing Balm SPF 10 Sunscreen CREAM TOPICAL 20140630 OTC MONOGRAPH FINAL part352 Linde Eckstein GmbH + Co. KG OCTINOXATE; OCTOCRYLENE 2; 2 g/50mL; g/50mL E 20171231 6889-0315_d9cc1665-7218-4df7-9f35-eae243f800bf 6889-0315 HUMAN OTC DRUG Beautipharm Body Moisturizer SPF 10 Sunscreen CREAM TOPICAL 20140630 OTC MONOGRAPH FINAL part352 Linde Eckstein GmbH + Co. KG OCTOCRYLENE; OCTINOXATE 10; 10 g/250mL; g/250mL E 20171231 6889-0319_ac6690d1-8064-4b48-b448-8dc3ad06cf4a 6889-0319 HUMAN OTC DRUG Beautipharm Eye Care Balm SPF 10 Sunscreen CREAM TOPICAL 20140630 OTC MONOGRAPH FINAL part352 Linde Eckstein GmbH + Co. KG OCTOCRYLENE; OCTINOXATE 1.33; 1.33 g/30mL; g/30mL E 20171231 68899-0001_c7af6197-fded-4de9-aa64-7535d3dda2db 68899-0001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040424 UNAPPROVED MEDICAL GAS Western Reserve Home Medical Eq. OXYGEN 99 L/100L E 20171231 68915-256_16b04391-8d87-4796-9323-a0a960eb592a 68915-256 HUMAN OTC DRUG AVVA vaginal Benzalkonium Chloride DOUCHE VAGINAL 20110520 OTC MONOGRAPH NOT FINAL part333A Eastern Century Pharmaceuticals BENZALKONIUM CHLORIDE .1 mL/100mL E 20171231 68915-280_52dddb14-2764-6b8d-e054-00144ff8d46c 68915-280 HUMAN OTC DRUG Guardian Vaginal Benzalkonium Chloride DOUCHE VAGINAL 20110523 OTC MONOGRAPH NOT FINAL part333A Eastern Century Pharmaceuticals BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 68927-0819_5948e403-a8b9-450c-8890-74af7639bf08 68927-0819 HUMAN OTC DRUG Visco-Gel Medicated Round Callus Removers SALICYLIC ACID DISC TOPICAL 20130601 OTC MONOGRAPH FINAL part358F PEDIFIX, INC. SALICYLIC ACID 17.67 mg/1 N 20181231 68927-3063_9b4e4d4d-7c10-4431-86b3-77e7b9497c41 68927-3063 HUMAN OTC DRUG Pedi-Quick OneStep Corn Removers SALICYLIC ACID STRIP TOPICAL 20130601 OTC MONOGRAPH FINAL part358F PEDIFIX, INC. SALICYLIC ACID 4.42 mg/1 N 20181231 68927-3490_480628ca-d00a-001b-e054-00144ff8d46c 68927-3490 HUMAN OTC DRUG ClotrimazOil Antifungal CLOTRIMAZOLE SOLUTION TOPICAL 20130619 OTC MONOGRAPH FINAL part333C Pedifix, Inc. CLOTRIMAZOLE 10 mg/mL N 20181231 68927-3491_c61c85e2-e0b8-47e1-b02e-31a00d11138f 68927-3491 HUMAN OTC DRUG Clotrimazole Clotrimazole LIQUID TOPICAL 20140505 OTC MONOGRAPH FINAL part333C Pedifix CLOTRIMAZOLE 10 mg/mL E 20171231 68927-3492_526db92b-9af6-4bf0-884c-c997b438f22d 68927-3492 HUMAN OTC DRUG FungaZoil Advanced Clotrimazole 1% LIQUID TOPICAL 20140615 OTC MONOGRAPH FINAL part333C Pedifix CLOTRIMAZOLE 10 mg/mL E 20171231 68960-0001_2bef8157-907b-4533-e054-00144ff8d46c 68960-0001 HUMAN OTC DRUG LEMON MYRTLE MACADAMIA SEED OIL TOPICAL 20160216 UNAPPROVED DRUG OTHER Lemonmyrtle Korea Co.,ltd MACADAMIA SEED OIL GLYCERETH-8 ESTERS 85.006 g/100mL E 20171231 68968-0514_e25fbda6-4264-455c-a182-6e34f86dad87 68968-0514 HUMAN PRESCRIPTION DRUG CombiPatch (estradiol/norethindrone acetate transdermal system) estradiol/norethindrone acetate transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 19980807 NDA NDA020870 Noven Therapeutics, LLC ESTRADIOL; NORETHINDRONE ACETATE .05; .14 mg/d; mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68968-0525_e25fbda6-4264-455c-a182-6e34f86dad87 68968-0525 HUMAN PRESCRIPTION DRUG CombiPatch (estradiol/norethindrone acetate transdermal system) estradiol/norethindrone acetate transdermal system PATCH, EXTENDED RELEASE TRANSDERMAL 19980807 NDA NDA020870 Noven Therapeutics, LLC ESTRADIOL; NORETHINDRONE ACETATE .05; .25 mg/d; mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 68968-5552_f526407e-6072-479a-8001-d90f3121c661 68968-5552 HUMAN PRESCRIPTION DRUG Daytrana methylphenidate PATCH TRANSDERMAL 20060406 NDA NDA021514 Noven Therapeutics, LLC METHYLPHENIDATE 10 mg/9h Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68968-5553_f526407e-6072-479a-8001-d90f3121c661 68968-5553 HUMAN PRESCRIPTION DRUG Daytrana methylphenidate PATCH TRANSDERMAL 20060406 NDA NDA021514 Noven Therapeutics, LLC METHYLPHENIDATE 15 mg/9h Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68968-5554_f526407e-6072-479a-8001-d90f3121c661 68968-5554 HUMAN PRESCRIPTION DRUG Daytrana methylphenidate PATCH TRANSDERMAL 20060406 NDA NDA021514 Noven Therapeutics, LLC METHYLPHENIDATE 20 mg/9h Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68968-5555_f526407e-6072-479a-8001-d90f3121c661 68968-5555 HUMAN PRESCRIPTION DRUG Daytrana methylphenidate PATCH TRANSDERMAL 20060406 NDA NDA021514 Noven Therapeutics, LLC METHYLPHENIDATE 30 mg/9h Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 68968-6610_762e72ab-79f2-4de9-a7ca-efe6752f4a8a 68968-6610 HUMAN PRESCRIPTION DRUG Minivelle estradiol FILM, EXTENDED RELEASE TRANSDERMAL 20121220 NDA NDA203752 Noven Therapeutics, LLC ESTRADIOL .1 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68968-6625_762e72ab-79f2-4de9-a7ca-efe6752f4a8a 68968-6625 HUMAN PRESCRIPTION DRUG Minivelle estradiol FILM, EXTENDED RELEASE TRANSDERMAL 20121220 NDA NDA203752 Noven Therapeutics, LLC ESTRADIOL .025 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68968-6637_762e72ab-79f2-4de9-a7ca-efe6752f4a8a 68968-6637 HUMAN PRESCRIPTION DRUG Minivelle estradiol FILM, EXTENDED RELEASE TRANSDERMAL 20121220 NDA NDA203752 Noven Therapeutics, LLC ESTRADIOL .0375 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68968-6650_762e72ab-79f2-4de9-a7ca-efe6752f4a8a 68968-6650 HUMAN PRESCRIPTION DRUG Minivelle estradiol FILM, EXTENDED RELEASE TRANSDERMAL 20121220 NDA NDA203752 Noven Therapeutics, LLC ESTRADIOL .05 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68968-6675_762e72ab-79f2-4de9-a7ca-efe6752f4a8a 68968-6675 HUMAN PRESCRIPTION DRUG Minivelle estradiol FILM, EXTENDED RELEASE TRANSDERMAL 20121220 NDA NDA203752 Noven Therapeutics, LLC ESTRADIOL .075 mg/d Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 68971-001_72184c71-b543-4075-8c74-07303e2d79b0 68971-001 HUMAN OTC DRUG X-PEL Anti-Lice Apis Mellifica, Carbolicum Acidum, Ledum Palustre SHAMPOO TOPICAL 20140415 UNAPPROVED HOMEOPATHIC Briangeli Beauty Enterprises APIS MELLIFERA; PHENOL; LEDUM PALUSTRE TWIG 15; 15; 15 [hp_X]/170g; [hp_X]/170g; [hp_X]/170g E 20171231 68971-002_f4883afe-8ee1-4bad-a973-60392b36d51b 68971-002 HUMAN OTC DRUG X-PEL PURE Anti-Lice Apis Mellifica, Carbolicum Acidum, Ledum Palustre SHAMPOO TOPICAL 20140415 UNAPPROVED HOMEOPATHIC Briangelis Beauty Entps Corp APIS MELLIFERA; PHENOL; LEDUM PALUSTRE TWIG 15; 15; 15 [hp_X]/170g; [hp_X]/170g; [hp_X]/170g E 20171231 68973-001_f18f14a5-84ba-47a4-bc6c-23f5c232a8c5 68973-001 HUMAN OTC DRUG Bon Balm Penetrating Pain Relief Menthol Methyl Salicylate OIL TOPICAL 20140515 OTC MONOGRAPH NOT FINAL part348 PMC TRADE, EXPORT AND IMPORT CAMPHOR (SYNTHETIC); MENTHOL 6; 1.25 g/100mL; g/100mL E 20171231 68973-002_b7c1dcd4-75d3-44c2-8344-ca5e0ddabddc 68973-002 HUMAN OTC DRUG Renuee dimethicone CREAM TOPICAL 20140715 OTC MONOGRAPH FINAL part347 PMC TRADE, EXPORT AND IMPORT DIMETHICONE 2 g/100g E 20171231 68974-876_277566fc-6896-45e7-913d-b7a74291f07f 68974-876 HUMAN PRESCRIPTION DRUG Chenodal Chenodiol TABLET, FILM COATED ORAL 20151228 ANDA ANDA091019 Retrophin, Inc. CHENODIOL 250 mg/1 E 20171231 68975-181_4cbe849d-1434-4ff1-8fda-950bda23143f 68975-181 HUMAN OTC DRUG PROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL tolnaftate solution LIQUID TOPICAL 20170310 OTC MONOGRAPH FINAL part333C Emilia Resources, LLC TOLNAFTATE 10 mg/mL N 20181231 68975-200_49f6a2ef-b316-42d8-8ea0-9862bf0a6573 68975-200 HUMAN OTC DRUG Harmon Face Values Revitalizing Day Cream ENSULIZOLE, OCTINOXATE CREAM TOPICAL 20170625 OTC MONOGRAPH NOT FINAL part352 Emilia Resources, LLC ENSULIZOLE; OCTINOXATE 1.19; 5.25 g/70g; g/70g N 20181231 68982-139_113a27c5-c814-47b8-b97f-e95ba654bf5a 68982-139 PLASMA DERIVATIVE NUWIQ Antihemophilic Factor (Recombinant) KIT INTRAVENOUS 20160101 BLA BLA125555 Octapharma USA Inc N 20181231 68982-141_113a27c5-c814-47b8-b97f-e95ba654bf5a 68982-141 PLASMA DERIVATIVE NUWIQ Antihemophilic Factor (Recombinant) KIT INTRAVENOUS 20160101 BLA BLA125555 Octapharma USA Inc N 20181231 68982-143_113a27c5-c814-47b8-b97f-e95ba654bf5a 68982-143 PLASMA DERIVATIVE NUWIQ Antihemophilic Factor (Recombinant) KIT INTRAVENOUS 20160101 BLA BLA125555 Octapharma USA Inc N 20181231 68982-145_113a27c5-c814-47b8-b97f-e95ba654bf5a 68982-145 PLASMA DERIVATIVE NUWIQ Antihemophilic Factor (Recombinant) KIT INTRAVENOUS 20160101 BLA BLA125555 Octapharma USA Inc N 20181231 68982-147_113a27c5-c814-47b8-b97f-e95ba654bf5a 68982-147 PLASMA DERIVATIVE NUWIQ Antihemophilic Factor (Recombinant) KIT INTRAVENOUS 20170801 BLA BLA125555 Octapharma USA Inc N 20181231 68982-149_113a27c5-c814-47b8-b97f-e95ba654bf5a 68982-149 PLASMA DERIVATIVE NUWIQ Antihemophilic Factor (Recombinant) KIT INTRAVENOUS 20170801 BLA BLA125555 Octapharma USA Inc N 20181231 68982-151_113a27c5-c814-47b8-b97f-e95ba654bf5a 68982-151 PLASMA DERIVATIVE NUWIQ Antihemophilic Factor (Recombinant) KIT INTRAVENOUS 20170801 BLA BLA125555 Octapharma USA Inc N 20181231 68982-182_42817081-7b9f-4c3d-a433-7aacd33f8c09 68982-182 PLASMA DERIVATIVE Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human) von Willebrand Factor/Coagulation Factor VIII Complex (Human) POWDER, FOR SOLUTION INTRAVENOUS 20091204 BLA BLA125251 Octapharma USA Inc ANTIHEMOPHILIC FACTOR HUMAN; VON WILLEBRAND FACTOR HUMAN 100; 100 [iU]/mL; [iU]/mL Human Antihemophilic Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [Chemical/Ingredient],Factor VIII [Chemical/Ingredient],Human Blood Coagulation Factor [EPC],Increased Platelet Aggregation [PE],Increased Coagulation Activity [PE],von Willebrand Factor [Chemical/Ingredient],Blood Coagulation Factors [Chemical/Ingredient] N 20191231 68982-347_c658dddc-0103-4196-99aa-88fbc75ac57a 68982-347 PLASMA DERIVATIVE Fibryga Fibrinogen Concentrate (Human) KIT INTRAVENOUS 20171016 BLA BLA125612 Octapharma USA Inc N 20181231 68982-623_2996f46f-5068-5421-5303-87a6bb765125 68982-623 PLASMA DERIVATIVE Albumin (Human) Albumin Human SOLUTION INTRAVENOUS 20061017 BLA BLA125154 Octapharma USA Inc ALBUMIN (HUMAN) 50 g/1000mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 68982-633_30788b01-3999-4048-906d-27a30d3b08c6 68982-633 PLASMA DERIVATIVE Albumin (Human) Albumin Human SOLUTION INTRAVENOUS 20061017 BLA BLA125154 Octapharma USA Inc ALBUMIN (HUMAN) 200 g/1000mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 68982-643_9854f56a-2fee-fd28-0a5e-2d8c63d95a16 68982-643 PLASMA DERIVATIVE Albumin (Human) Albumin Human SOLUTION INTRAVENOUS 20061017 BLA BLA125154 Octapharma USA Inc ALBUMIN (HUMAN) 250 g/1000mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 68982-840_e0585aa6-a3d9-2e67-07fe-d0a7b90f2926 68982-840 PLASMA DERIVATIVE Octagam Immune Globulin (Human) Immune Globulin SOLUTION INTRAVENOUS 20040521 BLA BLA125062 Octapharma USA Inc HUMAN IMMUNOGLOBULIN G 50 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 68982-850_d780ed09-c179-3787-d75b-5030945024f7 68982-850 PLASMA DERIVATIVE Octagam Immune Globulin (Human) Immune Globulin SOLUTION INTRAVENOUS 20040521 BLA BLA125062 Octapharma USA Inc HUMAN IMMUNOGLOBULIN G 100 mg/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 68982-952_31e0d6f1-df02-0b01-2995-af88f7fbc523 68982-952 PLASMA DERIVATIVE Octaplas human plasma proteins SOLUTION INTRAVENOUS 20130718 BLA BLA125416 Octapharma USA Inc PLASMA PROTEIN FRACTION (HUMAN) 11.5 g/200mL N 20181231 68982-953_7603713f-4aa0-0395-0233-587c80578fca 68982-953 PLASMA DERIVATIVE Octaplas human plasma proteins SOLUTION INTRAVENOUS 20130718 BLA BLA125416 Octapharma USA Inc PLASMA PROTEIN FRACTION (HUMAN) 11.5 g/200mL N 20181231 68982-954_ff82a0eb-fdd4-1b18-0890-7f0f19a911a0 68982-954 PLASMA DERIVATIVE Octaplas human plasma proteins SOLUTION INTRAVENOUS 20130718 BLA BLA125416 Octapharma USA Inc PLASMA PROTEIN FRACTION (HUMAN) 11.5 g/200mL N 20181231 68982-955_0be69acf-46b5-bf59-1850-0e010c1091bb 68982-955 PLASMA DERIVATIVE Octaplas human plasma proteins SOLUTION INTRAVENOUS 20130718 BLA BLA125416 Octapharma USA Inc PLASMA PROTEIN FRACTION (HUMAN) 11.5 g/200mL N 20181231 68983-001_4b402080-b15c-41d2-80ed-7a4f2fdf038a 68983-001 HUMAN OTC DRUG Pac-Dent Top Gel Benzocaine GEL DENTAL 20130601 OTC MONOGRAPH NOT FINAL part356 Pac-Dent International, Inc. BENZOCAINE 200 mg/g N 20181231 68983-002_0dc51526-8572-40ea-b8ad-4978cd58f914 68983-002 HUMAN OTC DRUG Pac-Dent Top Gel Benzocaine GEL DENTAL 20130601 OTC MONOGRAPH NOT FINAL part356 Pac-Dent International, Inc. BENZOCAINE 200 mg/g N 20181231 68983-003_b953a619-d938-4d93-bd70-587635ae1bf8 68983-003 HUMAN OTC DRUG Pac-Dent Top Gel Benzocaine GEL DENTAL 20130601 OTC MONOGRAPH NOT FINAL part356 Pac-Dent International, Inc. BENZOCAINE 200 mg/g N 20181231 68983-004_2a691b9b-32be-47a9-9e88-487df195570d 68983-004 HUMAN OTC DRUG Pac-Dent Top Gel Benzocaine GEL DENTAL 20130601 OTC MONOGRAPH NOT FINAL part356 Pac-Dent International, Inc. BENZOCAINE 200 mg/g N 20181231 68983-005_dccdd00e-aa22-402d-b2e0-4151ab71ba9e 68983-005 HUMAN OTC DRUG Pac-Dent Top Gel Benzocaine GEL DENTAL 20130601 OTC MONOGRAPH NOT FINAL part356 Pac-Dent International, Inc. BENZOCAINE 200 mg/g N 20181231 68983-006_25f0e453-ed77-141b-e054-00144ff8d46c 68983-006 HUMAN OTC DRUG iBrite Sodium Fluoride, Potassium Nitrate PASTE, DENTIFRICE ORAL 20160201 OTC MONOGRAPH NOT FINAL part356 Pac-Dent International Inc. SODIUM FLUORIDE; POTASSIUM NITRATE 2.54; 30 mg/g; mg/g E 20171231 68984-001_9455ae0a-ddd9-4f21-ba3e-f1543cf719c3 68984-001 HUMAN OTC DRUG Vagical CALENDULA OFFICINALIS FLOWERING TOP INSERT VAGINAL 20140529 UNAPPROVED HOMEOPATHIC Farmina sp. z o.o. CALENDULA OFFICINALIS FLOWERING TOP 150 mg/1 N 20181231 68987-001_b60675fe-2ad5-47ac-9a2c-15f5b1464bf0 68987-001 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g N 20181231 68987-002_a2934a35-f79b-472c-9b91-980d54c19afc 68987-002 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g N 20181231 68987-003_90f42f0c-dbd1-4b79-bc50-f4ba7772c3d0 68987-003 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g N 20181231 68987-004_ebea6526-8660-4495-bb1c-5fdd829b0230 68987-004 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g N 20181231 68987-005_48bb955d-2b65-4e2b-ae64-d29e171e25cb 68987-005 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g N 20181231 68987-006_c7408efd-8431-48f4-ad98-815d38fdb308 68987-006 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g N 20181231 68987-007_675ed5af-5d14-4757-8a1e-ae12c968956f 68987-007 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g N 20181231 68987-008_db9d3b44-98d8-4475-a954-a5e8846ea760 68987-008 HUMAN OTC DRUG PureLife Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 PureLife Dental BENZOCAINE 200 mg/g N 20181231 68987-010_5ca285b2-2883-4cd5-85d5-94c57b1f2f6a 68987-010 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 68987-011_32717cf0-8928-4cbc-965f-db23f9073693 68987-011 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 68987-012_7dc309d3-0c90-4a74-af16-ec9b59f297ed 68987-012 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 68987-013_8091d893-6aea-4152-98ff-22db16ba6140 68987-013 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 68987-014_0ac7cd30-3755-4cbe-8096-37f4adbd7a83 68987-014 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride GEL DENTAL 20121218 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 68987-020_4691f44e-1199-4335-aeeb-295eb8afc6bd 68987-020 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 1.5375 g/125g E 20171231 68987-021_5198f457-335d-4559-9bad-366c3c2923f5 68987-021 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 1.5375 g/125g E 20171231 68987-022_156d6f85-3151-4728-a8a7-85ead3da6f1f 68987-022 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 1.5375 g/125g E 20171231 68987-023_d249cff8-92ec-440c-89cb-9b61e0adca0c 68987-023 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 1.5375 g/125g E 20171231 68987-024_db76ff96-2fda-4424-b937-90bbb738b5e0 68987-024 HUMAN PRESCRIPTION DRUG PureLife APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130327 UNAPPROVED DRUG OTHER PureLife Dental SODIUM FLUORIDE 1.5375 g/125g E 20171231 68988-010_ff0a4d93-9b22-4912-9cee-14bf4939d7c5 68988-010 HUMAN OTC DRUG PLAGENTRA MOTHERS BELLY Dimethicone LOTION TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. DIMETHICONE 3 mg/150mL E 20171231 68988-020_d5ec9155-07c0-4923-b00b-31891275f103 68988-020 HUMAN OTC DRUG PLAGENTRA MOTHERS BELLY Glycerin CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. GLYCERIN 24 g/120g E 20171231 68988-030_24737d57-e310-465f-ba48-784ee6082cbd 68988-030 HUMAN OTC DRUG PLAGENTRA MOTHERS BELLY Allantoin OIL TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. ALLANTOIN .75 mg/150mL E 20171231 68988-040_fc769023-e438-4ac4-95e0-119339d9da25 68988-040 HUMAN OTC DRUG PLAGENTRA INTENSIVE CARE Dimethicone CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. DIMETHICONE 2 g/100g E 20171231 68988-050_103494f4-734e-4bf4-b958-17632f70339d 68988-050 HUMAN OTC DRUG PLAGENTRA INTENSIVE CARE Dimethicone LOTION TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. DIMETHICONE 3 mg/150mL E 20171231 68988-060_a501ba90-bab6-41ad-87db-9e1156474990 68988-060 HUMAN OTC DRUG PLAGENTRA BABY Dimethicone CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. DIMETHICONE 1 g/100g E 20171231 68988-070_fb018c88-d502-4095-a538-f8084fd67123 68988-070 HUMAN OTC DRUG PLAGENTRA BABY Glycerin LOTION TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. GLYCERIN 20 mg/100mL E 20171231 68988-080_103fde0f-196c-4c2a-8295-db3384bb9a12 68988-080 HUMAN OTC DRUG PLAGENTRA BABY BUBBLE WASH Allantoin AEROSOL, FOAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. ALLANTOIN 1.25 mg/250mL E 20171231 68988-090_79cb3c5f-6d46-4843-8780-51252a079b90 68988-090 HUMAN OTC DRUG PLAGENTRA BABY SUNCITY OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 C.A Pharm Co., Ltd. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 4.5; 3; 1.8 g/60g; g/60g; g/60g E 20171231 68988-100_92ee52fc-7fbe-4d53-91aa-1f346f2fdaea 68988-100 HUMAN OTC DRUG PLAGENTRA BABY SOOTHING RELIEF Dimethicone CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 C.A Pharm Co., Ltd. DIMETHICONE 1.6 g/80g E 20171231 68988-110_1c5a2989-d244-4468-b01b-3ac337d33ee0 68988-110 HUMAN OTC DRUG PLAGENTRA SOOTHING REVOLUTION BB Titanium Dioxide, OCTINOXATE, Zinc Oxide CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 C.A Pharm Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.77; 2.25; .35 g/30g; g/30g; g/30g E 20171231 68988-120_f15581ea-514d-44c8-af6d-0472d5d4bf0c 68988-120 HUMAN OTC DRUG PLAGENTRA SOOTHING REVOLUTION SUNCITY OCTINOXATE, OCTISALATE CREAM TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 C.A Pharm Co., Ltd. OCTINOXATE; OCTISALATE 2.25; 2.25 g/45g; g/45g E 20171231 68989-575_b305ec3a-6ecf-4f9b-9594-d28e4178e83f 68989-575 HUMAN OTC DRUG Happy Hands Foaming Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E On The Job, LLC BENZETHONIUM CHLORIDE 2 mg/mL E 20171231 68990-001_af1ae44b-daee-435f-92f3-fc332e54f383 68990-001 HUMAN OTC DRUG SYS Octinoxate, Titanium Dioxide LOTION TOPICAL 20140601 OTC MONOGRAPH FINAL part352 AdvoCare International L.P. OCTINOXATE; TITANIUM DIOXIDE 3.75; 3 g/50mL; g/50mL E 20171231 68991-001_0d52149c-7534-43f5-980c-9d17a88b9dd6 68991-001 HUMAN OTC DRUG KANG DU QING POLOXAMER 188 GEL VAGINAL 20110520 OTC MONOGRAPH NOT FINAL part333A Shenzhen Senton Science & Technology Co. Ltd POLOXAMER 188 2.7 g/100g E 20171231 68992-3010_f99bc24f-1f15-4921-8fde-741d76360313 68992-3010 HUMAN PRESCRIPTION DRUG Envarsus XR Tacrolimus TABLET, EXTENDED RELEASE ORAL 20150901 NDA NDA206406 Veloxis Pharmaceuticals, Inc TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 68992-3040_f99bc24f-1f15-4921-8fde-741d76360313 68992-3040 HUMAN PRESCRIPTION DRUG Envarsus XR Tacrolimus TABLET, EXTENDED RELEASE ORAL 20150901 NDA NDA206406 Veloxis Pharmaceuticals, Inc TACROLIMUS 4 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 68992-3075_f99bc24f-1f15-4921-8fde-741d76360313 68992-3075 HUMAN PRESCRIPTION DRUG Envarsus XR Tacrolimus TABLET, EXTENDED RELEASE ORAL 20150901 NDA NDA206406 Veloxis Pharmaceuticals, Inc TACROLIMUS .75 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 68994-1001_8355c4a6-f9a4-4ab1-9b46-92c09a7ec0fe 68994-1001 HUMAN OTC DRUG Hyundai Moolpas F METHYL SALICYLATE SOLUTION TRANSDERMAL 20140516 OTC MONOGRAPH NOT FINAL part348 Scott Holdings Co., Ltd. METHYL SALICYLATE 3 g/100mL E 20171231 68994-2001_05999698-c1da-4f28-a82e-1ca80271eb8c 68994-2001 HUMAN OTC DRUG Bumooly-S METHYL SALICYLATE SOLUTION TRANSDERMAL 20140516 OTC MONOGRAPH NOT FINAL part348 Scott Holdings Co., Ltd. METHYL SALICYLATE 3 g/100mL E 20171231 68994-3001_0ad679b4-61fd-4dbe-a4f4-14145f379aaf 68994-3001 HUMAN OTC DRUG Hyundai Moolpas F METHYL SALICYLATE SOLUTION TRANSDERMAL 20140925 OTC MONOGRAPH FINAL part348 Scott Holdings Co., Ltd. METHYL SALICYLATE 3 g/100mL E 20171231 68994-4001_55447fd9-cf7d-4aa3-bc71-8663ced28016 68994-4001 HUMAN OTC DRUG Bumooly-S METHYL SALICYLATE SOLUTION TRANSDERMAL 20140925 OTC MONOGRAPH FINAL part348 Scott Holdings Co., Ltd. METHYL SALICYLATE 3 g/100mL E 20171231 68996-101_8545d964-dfda-4483-94f6-2399179d71b0 68996-101 HUMAN PRESCRIPTION DRUG AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE TABLET ORAL 20170301 ANDA ANDA207571 NewGen Pharmaceuticals LLC AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 68996-102_222dda16-f466-409e-b816-6a67c10971af 68996-102 HUMAN PRESCRIPTION DRUG AMANTADINE HYDROCHLORIDE AMANTADINE HYDROCHLORIDE CAPSULE ORAL 20170228 ANDA ANDA207570 NewGen Pharmaceuticals LLC AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 68998-046_91de0da4-ac43-4fb5-8fb9-c61f90cc35ca 68998-046 HUMAN OTC DRUG Bismuth Chewable Bismuth Subsalicylate 262 mg TABLET, CHEWABLE ORAL 20030428 OTC MONOGRAPH FINAL part335 Marc Glassman, Inc. BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 68998-076_543bf0ca-1397-42e4-9dfb-dee815ce0ab4 68998-076 HUMAN OTC DRUG Stay Awake Caffeine TABLET, COATED ORAL 20140701 OTC MONOGRAPH FINAL part340 Marc Glassman, Inc. CAFFEINE 200 mg/1 E 20171231 68998-100_44215f5e-0f82-e82b-6d1d-bb6aed49bd7f 68998-100 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160328 ANDA ANDA208150 Marc Glassman, Inc. FLUTICASONE PROPIONATE 50 ug/1 N 20181231 68998-226_21f600dd-fd27-45f9-aed5-ede709b0db4b 68998-226 HUMAN OTC DRUG Laxative Tabelts Bisacodyl TABLET, DELAYED RELEASE ORAL 20140701 OTC MONOGRAPH NOT FINAL part334 Marc Glassman, Inc. BISACODYL 5 mg/1 N 20181231 68998-232_98dbd3f1-c34b-4f93-9ffd-0ad6fa7f47d3 68998-232 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, DELAYED RELEASE ORAL 20140701 OTC MONOGRAPH NOT FINAL part334 Marc Glassman, Inc. BISACODYL 5 mg/1 N 20181231 68998-277_bd3361dc-3b45-4368-ad6b-5a55df617bc3 68998-277 HUMAN OTC DRUG Allergy Chlorpheniramine Maleate TABLET, COATED ORAL 20141215 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 68998-309_ca54cb11-e009-4737-808b-d7b90422b99c 68998-309 HUMAN OTC DRUG Allergy Relief Loratadine TABLET ORAL 20141216 ANDA ANDA076471 Marc Glassman, Inc. LORATADINE 10 mg/1 N 20181231 68998-311_022b3191-9ee4-4210-9c9a-df7aa2041f4a 68998-311 HUMAN OTC DRUG Day Time Cold and Flu non drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 68998-314_fd5481f1-e517-4139-a896-2dd19d787cb3 68998-314 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE, GELATIN COATED ORAL 20141223 OTC MONOGRAPH NOT FINAL part334 Marc Glassman, Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 68998-343_ff8c5ec3-8f6b-467c-a519-14d8ebfab101 68998-343 HUMAN OTC DRUG Nighttime Cold and Flu cherry Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 68998-344_4c2ab21e-0a83-4f5c-8d0f-8dc892b48edd 68998-344 HUMAN OTC DRUG Nighttime Cold and Flu original Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 68998-345_9a64e582-e094-4bf7-bf63-a9b232d1e2b2 68998-345 HUMAN OTC DRUG Night Time Cough cherry Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20140831 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 68998-371_f58f35dd-27cd-49e7-a3ad-c4d3779ede26 68998-371 HUMAN OTC DRUG Peptic Relief Maximum Strength Bismuth subsalicylate LIQUID ORAL 20150331 OTC MONOGRAPH FINAL part335 Marc Glassman, Inc. BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 68998-372_5c2cf152-e49b-4233-9faf-601347afb87b 68998-372 HUMAN OTC DRUG Peptic Relief Bismuth subsalicylate LIQUID ORAL 20150228 OTC MONOGRAPH FINAL part335 Marc Glassman, Inc. BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 68998-375_8d493f06-e5c2-485a-9996-9bd3a4441e20 68998-375 HUMAN OTC DRUG Ranitidine 150 Ranitidine HCl Tablets 150mg TABLET, COATED ORAL 20100105 ANDA ANDA078192 Marc Glassman, Inc. RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 68998-382_78b1361d-00a3-4c61-aa81-05e869d2d7bc 68998-382 HUMAN OTC DRUG Tussin CF Adult Multi Symptom Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20140930 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 68998-385_538bb666-9ce7-46d5-8e1c-91bc79fafcf8 68998-385 HUMAN OTC DRUG Tussin DM Cough and Chest Congestion Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20141130 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 68998-386_581ab73d-06a8-4210-8a40-5cc526f7902d 68998-386 HUMAN OTC DRUG TUSSIN DM MAX ADULT COUGH PLUS CHEST CONGESTION Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20150811 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 68998-465_c718ed43-e845-4930-b702-6f683f7554b0 68998-465 HUMAN OTC DRUG EasyLAX Polyethylene Glycol POWDER TOPICAL 20160831 ANDA ANDA091077 Marc Glassman, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 68998-466_d51e3624-9960-4b49-9d32-4d24ab59065a 68998-466 HUMAN OTC DRUG Daytime Cold and Flu Non drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20150731 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 68998-505_b6d10782-44f8-4569-8013-0b6a92e6eb82 68998-505 HUMAN OTC DRUG Childrens Allergy Relief DIPHENHYDRAMINE HCL LIQUID ORAL 20141202 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 68998-525_e1800450-f6a6-423a-88aa-dbc597cc8306 68998-525 HUMAN OTC DRUG Childrens Pain and Fever ACETAMINOPHEN LIQUID ORAL 20141010 OTC MONOGRAPH NOT FINAL part343 Marc Glassman, Inc. ACETAMINOPHEN 160 mg/5mL E 20171231 68998-526_5490bb07-2d9c-4a22-8e5a-548f606d281b 68998-526 HUMAN OTC DRUG Peptic Relief bismuth subsalicylate LIQUID ORAL 20170401 OTC MONOGRAPH FINAL part335 Marc Glassman, Inc. BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 68998-527_015509e2-ddb5-4291-b737-11cc348a3771 68998-527 HUMAN OTC DRUG Peptic Relief Peptic Relief LIQUID ORAL 20170401 OTC MONOGRAPH FINAL part335 Marc Glassman, Inc. BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 68998-528_3b81d6be-7014-4d9a-80ff-3296fd0478a4 68998-528 HUMAN OTC DRUG Adult Tussin CF Multi-Symptom Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20170714 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 68998-529_5e448049-a834-4e21-a397-254e31313188 68998-529 HUMAN OTC DRUG ADULT TUSSIN DM COUGH PLUS CHEST CONGESTION DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20170714 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 68998-530_dda4ed63-6e17-4d6b-9d7a-097511fa634a 68998-530 HUMAN OTC DRUG Day Time COLD and FLU non-drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl LIQUID ORAL 20170714 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 68998-531_5d7304be-83e9-4b86-9aa9-7bb5d5f72d2a 68998-531 HUMAN OTC DRUG Night Time Cold and Flu Original Acetaminophen, Doxylamine succinate, and Dextromethorphan HBr LIQUID ORAL 20170720 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 68998-532_0046fac2-df34-4c8e-b0c0-5f1fcd5c15b1 68998-532 HUMAN OTC DRUG NIGHT TIME COLD and FLU CHERRY Acetaminophen, Doxylamine succinate, Dextromethorphan HBr LIQUID ORAL 20170715 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 68998-533_196d2180-17b0-43fd-89d1-863ba7822f79 68998-533 HUMAN OTC DRUG NIGHT TIME COUGH CHERRY Dextromethorphan HBr, Doxylamine succinate LIQUID ORAL 20170714 OTC MONOGRAPH FINAL part341 Marc Glassman, Inc. DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 68998-600_51b2d2ba-a162-22c5-fea6-903be5668190 68998-600 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20170703 ANDA ANDA208150 Marc Glassman, Inc. FLUTICASONE PROPIONATE 50 ug/1 N 20181231 68998-950_ef6202b2-5321-4391-ac89-a8329662b806 68998-950 HUMAN OTC DRUG Mucus Relief DM MAX Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Marc Glassman, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 68999-417_a75acfde-ad72-4c48-b8b3-e22cf9cb7b09 68999-417 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline POWDER, FOR SUSPENSION ORAL 20080716 ANDA ANDA065454 CHARTWELL GOVERNMENTAL & SPECIALTY RX LLC DOXYCYCLINE 25 mg/5mL N 20181231 68999-626_4585502f-856f-4bc5-9ba3-2382ae42be94 68999-626 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 CHARTWELL GOVERNMENTAL & SPECIALTY RX LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 68999-984_6670b07b-76f9-4ed2-9626-01f4f59448fb 68999-984 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Chartwell Governmental and Specialty RX LLC DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 68999-985_6670b07b-76f9-4ed2-9626-01f4f59448fb 68999-985 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Chartwell Governmental and Specialty RX LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 69000-010_4ca66249-7358-40b6-9ca8-778752bc2663 69000-010 HUMAN OTC DRUG Time Frame Future Resist Foundation Broad Spectrum SPF 20 Delilah Cosmetics Titanium Dioxide LIQUID TOPICAL 20141007 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL N 20181231 69000-011_54ad45b3-f154-47e4-9cc8-fdd4946b457a 69000-011 HUMAN OTC DRUG Time Frame Future Resist Foundation Broad Spectrum SPF 20 Truffle Delilah Cosmetics Avobenzone, Octinoxate, Octocrylene SOLUTION TOPICAL 20141007 OTC MONOGRAPH FINAL part352 Delilah Cosmetics AVOBENZONE; OCTINOXATE; OCTOCRYLENE .6; 3; 3 g/100mL; g/100mL; g/100mL N 20181231 69000-018_2fae4acf-8a6b-4af2-9f12-4dc31dad3408 69000-018 HUMAN OTC DRUG Shell Future Resist Foundation Broad Spectrum SPF 20 Delilah Titanium Dioxide LOTION TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL N 20181231 69000-019_277749c1-c605-42b6-92e9-5f76d8ba0f61 69000-019 HUMAN OTC DRUG Lace Future Resist Broad Spectrum SPF 20 Foundation Delilah Titanium Dioxide LOTION TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL N 20181231 69000-020_8aadbb91-eb98-4341-a3b8-158c09218a24 69000-020 HUMAN OTC DRUG Buttermilk Future Resist Foundation Broad Spectrum SPF 20 Delilah Titanium Dioxide LOTION TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL N 20181231 69000-021_f801906c-4b43-42c6-8408-c67baaa0fc3f 69000-021 HUMAN OTC DRUG Pebble Future Resist Foundation Broad Spectrum SPF 20 Foundation Delilah Titanium Dioxide LIQUID TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL N 20181231 69000-022_29018b62-870c-46c8-9fac-ebd447426ebd 69000-022 HUMAN OTC DRUG Maple Future Resist Foundation Broad Spectrum SPF 20 Foundation Delilah Titanium Dioxide LIQUID TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL N 20181231 69000-023_8420e2c4-f383-4ae0-a536-3fd23236af1f 69000-023 HUMAN OTC DRUG Nutmeg Future Resist Foundation Broad Spectrum SPF 20 Foundation Delilah Titanium Dioxide LIQUID TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL N 20181231 69000-024_f9d1b5e7-9aca-4c05-9630-1f8eb651343d 69000-024 HUMAN OTC DRUG Chestnut Future Resist Foundation Broad Spectrum Foundation Delilah Titanium Dioxide LIQUID TOPICAL 20141013 OTC MONOGRAPH FINAL part352 Delilah Cosmetics TITANIUM DIOXIDE 5 g/100mL N 20181231 69003-412_385aafba-7dda-490b-b86f-afaf1bb79e29 69003-412 HUMAN OTC DRUG Naruko Taiwan Magnolia Firming Smooth Finish Cream Makeup Ethylhexyl Methoxycinnamate, Octocrylene, Zinc Oxide CREAM TOPICAL 20140514 OTC MONOGRAPH FINAL part352 Beauty Essentials Limited, Taiwan Branch OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 7.65; 3.08; 3.04 g/100g; g/100g; g/100g E 20171231 69004-001_495fe95d-5b49-41d8-b5a8-41c0f250c31c 69004-001 HUMAN OTC DRUG GPS Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Group Practice Solutions, Inc. BENZOCAINE 200 mg/g N 20181231 69004-002_95426339-2153-45fb-8baa-823cea37875e 69004-002 HUMAN OTC DRUG GPS Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Group Practice Solutions, Inc. BENZOCAINE 200 mg/g N 20181231 69004-003_0b4edcaa-baf7-4dd4-883c-6e6a0d36898d 69004-003 HUMAN OTC DRUG GPS Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Group Practice Solutions, Inc. BENZOCAINE 200 mg/g N 20181231 69004-004_b4fa4481-4a3f-40b2-ae77-2413c3217f11 69004-004 HUMAN OTC DRUG GPS Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Group Practice Solutions, Inc. BENZOCAINE 200 mg/g N 20181231 69004-005_5db8245d-cf06-4e9b-95bf-3b650b4da022 69004-005 HUMAN OTC DRUG GPS Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Group Practice Solutions, Inc. BENZOCAINE 200 mg/g N 20181231 69004-006_3d7d5092-48a4-4cca-8a14-6b0ba9ce8cb3 69004-006 HUMAN OTC DRUG GPS Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 Group Practice Solutions, Inc. BENZOCAINE 200 mg/g N 20181231 69006-002_40ce1140-4406-03e9-e054-00144ff8d46c 69006-002 HUMAN OTC DRUG Viabecline Tetracycline Hydrochloride OINTMENT TOPICAL 20161108 OTC MONOGRAPH FINAL part333B VIADERMA II, INC. TETRACYCLINE HYDROCHLORIDE 30 mg/mL N 20181231 69006-005_6108c09a-83f5-5d0f-e053-2991aa0a874a 69006-005 HUMAN OTC DRUG Viabecline First Aid Antibiotic TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20170513 OTC MONOGRAPH FINAL part333B VIADERMA II, INC. TETRACYCLINE HYDROCHLORIDE 30 mg/mL N 20181231 69006-010_6108c703-c6f5-e341-e053-2a91aa0a8be8 69006-010 HUMAN OTC DRUG Prolayed LIDOCAINE OINTMENT TOPICAL 20170623 OTC MONOGRAPH FINAL part333B ViaDerma, Inc LIDOCAINE 10 mg/mL N 20181231 69007-765_5fb0f21a-0f62-4aeb-a02e-cbbf2c32c784 69007-765 HUMAN PRESCRIPTION DRUG desonide desonide LOTION TOPICAL 19841214 ANDA ANDA072354 Owen Laboratories, Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69007-770_5fb0f21a-0f62-4aeb-a02e-cbbf2c32c784 69007-770 HUMAN PRESCRIPTION DRUG desonide desonide CREAM TOPICAL 19841214 NDA AUTHORIZED GENERIC NDA019048 Owen Laboratories, Inc. DESONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69007-822_c954fd97-3e5b-4fda-8f8e-74f4fc0b1601 69007-822 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20100514 NDA AUTHORIZED GENERIC NDA050805 Owen Laboratories, Inc. DOXYCYCLINE 40 mg/1 N 20181231 69007-835_960347a4-11bd-4c23-84a8-d4a3d9eafe1d 69007-835 HUMAN PRESCRIPTION DRUG Metronidazole Topical Gel metronidazole GEL TOPICAL 20140301 NDA AUTHORIZED GENERIC NDA019737 Owen Laboratories METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 69007-836_cd7304d0-0ac9-40d9-bc8b-8656d637f9fe 69007-836 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE CREAM TOPICAL 20090618 NDA AUTHORIZED GENERIC NDA020531 Owen Laboratories METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 69007-912_37259cdb-ed05-4e36-9ff6-e67b41cad7d7 69007-912 HUMAN PRESCRIPTION DRUG adapalene adapalene LOTION TOPICAL 20100331 NDA AUTHORIZED GENERIC NDA022502 Owen Laboratories, Inc. ADAPALENE .1 g/100mL Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 69007-918_ec947b61-6e3b-4444-9167-cab3cccfb6a7 69007-918 HUMAN PRESCRIPTION DRUG adapalene adapalene GEL TOPICAL 20090915 NDA AUTHORIZED GENERIC NDA021753 Owen Laboratories, Inc. ADAPALENE 3 mg/g Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 69008-0000_596434d8-527f-1d70-e053-2a91aa0aae44 69008-0000 HUMAN OTC DRUG Calcarea Fluorica Calcium Flouride TABLET ORAL 20170915 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic CALCIUM FLUORIDE 3 [hp_X]/1 N 20181231 69008-0001_58865807-25b7-5ba2-e053-2a91aa0ab83b 69008-0001 HUMAN OTC DRUG Calcarea Fluorica Calcium Flouride TABLET ORAL 20170915 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic CALCIUM FLUORIDE 6 [hp_X]/1 N 20181231 69008-0002_5963c9fe-ef3c-ee4c-e053-2991aa0a0ad6 69008-0002 HUMAN OTC DRUG Calcarea Fluorica Calcium Flouride TABLET ORAL 20170915 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic CALCIUM FLUORIDE 12 [hp_X]/1 N 20181231 69008-0003_58898696-75cc-c530-e053-2a91aa0a4792 69008-0003 HUMAN OTC DRUG Calcarea Phos Calcarea Phosphorica 3X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories TRIBASIC CALCIUM PHOSPHATE 3 [hp_X]/1 N 20181231 69008-0004_59643dd1-af75-7cf6-e053-2991aa0a144f 69008-0004 HUMAN OTC DRUG Calcarea Phos Calcarea Phosphorica 6X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories TRIBASIC CALCIUM PHOSPHATE 6 [hp_X]/1 N 20181231 69008-0005_59675dc4-8e70-e11e-e053-2a91aa0a54dc 69008-0005 HUMAN OTC DRUG Calcarea Phos Calcarea Phosphorica 12X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories TRIBASIC CALCIUM PHOSPHATE 12 [hp_X]/1 N 20181231 69008-0006_5889ca62-c01d-e115-e053-2991aa0a8b7c 69008-0006 HUMAN OTC DRUG Calcarea Sulph Calcarea Sulphurica TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoepathic Laboratories CALCIUM SULFATE 3 [hp_X]/1 N 20181231 69008-0007_596434d8-5290-1d70-e053-2a91aa0aae44 69008-0007 HUMAN OTC DRUG Calcarea Sulph Calcarea Sulphurica TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoepathic Laboratories CALCIUM SULFATE 6 [hp_X]/1 N 20181231 69008-0008_596434d8-52a0-1d70-e053-2a91aa0aae44 69008-0008 HUMAN OTC DRUG Calcarea Sulph Calcarea Sulphurica TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoepathic Laboratories CALCIUM SULFATE 12 [hp_X]/1 N 20181231 69008-0009_588a811b-720c-4ea8-e053-2991aa0a6b24 69008-0009 HUMAN OTC DRUG Ferrum Phos Ferrum Phosphoricum 3X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoepathic Laboratories FERRUM PHOSPHORICUM 3 [hp_X]/1 N 20181231 69008-0010_5964b143-89db-25d4-e053-2991aa0ab25b 69008-0010 HUMAN OTC DRUG Ferrum Phos Ferrum Phosphoricum 6X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoepathic Laboratories FERRUM PHOSPHORICUM 6 [hp_X]/1 N 20181231 69008-0011_5964c39a-1064-b733-e053-2991aa0a3f10 69008-0011 HUMAN OTC DRUG Ferrum Phos Ferrum Phosphoricum 12X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoepathic Laboratories FERRUM PHOSPHORICUM 12 [hp_X]/1 N 20181231 69008-0013_5964c39a-1069-b733-e053-2991aa0a3f10 69008-0013 HUMAN OTC DRUG Kali Mur Kali Muriaticum 6X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories POTASSIUM CHLORIDE 6 [hp_X]/1 N 20181231 69008-0014_5966cd01-1efc-2765-e053-2991aa0a5656 69008-0014 HUMAN OTC DRUG Kali Mur Kali Muriaticum 12X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories POTASSIUM CHLORIDE 12 [hp_X]/1 N 20181231 69008-0015_58901adc-fd32-0a8a-e053-2a91aa0a2c68 69008-0015 HUMAN OTC DRUG Kali Phos Kalium Phosphoricum 3X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories POTASSIUM PHOSPHATE, UNSPECIFIED FORM 3 [hp_X]/1 N 20181231 69008-0016_5964ef82-1d9c-2859-e053-2a91aa0a5358 69008-0016 HUMAN OTC DRUG Kali Phos Kalium Phosphoricum 6X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories POTASSIUM PHOSPHATE, UNSPECIFIED FORM 6 [hp_X]/1 N 20181231 69008-0017_5966babe-bad8-4ef1-e053-2991aa0ae8c5 69008-0017 HUMAN OTC DRUG Kali Phos Kalium Phosphoricum 12X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories POTASSIUM PHOSPHATE, UNSPECIFIED FORM 12 [hp_X]/1 N 20181231 69008-0018_589082ea-50ef-3b0b-e053-2a91aa0a9d2f 69008-0018 HUMAN OTC DRUG Kali Sulph Potassium Sulfate TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories POTASSIUM SULFATE 3 [hp_X]/1 N 20181231 69008-0019_596355c7-bba0-6ddb-e053-2991aa0a770b 69008-0019 HUMAN OTC DRUG Kali Sulph Potassium Sulfate TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories POTASSIUM SULFATE 6 [hp_X]/1 N 20181231 69008-0020_596355c7-bbad-6ddb-e053-2991aa0a770b 69008-0020 HUMAN OTC DRUG Kali Sulph Potassium Sulfate TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories POTASSIUM SULFATE 12 [hp_X]/1 N 20181231 69008-0021_5890bbc9-6d82-0369-e053-2991aa0a66c0 69008-0021 HUMAN OTC DRUG Mag Phos Magnesia Phosphorica 3X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 3 [hp_X]/1 N 20181231 69008-0022_5966cd01-1eea-2765-e053-2991aa0a5656 69008-0022 HUMAN OTC DRUG Mag Phos Magnesia Phosphorica 6X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X]/1 N 20181231 69008-0023_5966babe-bafd-4ef1-e053-2991aa0ae8c5 69008-0023 HUMAN OTC DRUG Mag Phos Magnesia Phosphorica 12X TABLET ORAL 20170906 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X]/1 N 20181231 69008-0024_58999a17-5344-e2fc-e053-2991aa0ab45b 69008-0024 HUMAN OTC DRUG Natrum Mur Natrum Muriaticum TABLET ORAL 20170907 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SODIUM CHLORIDE 3 [hp_X]/1 N 20181231 69008-0025_5966babe-bb1d-4ef1-e053-2991aa0ae8c5 69008-0025 HUMAN OTC DRUG Natrum Mur Natrum Muriaticum 6X TABLET ORAL 20170907 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SODIUM CHLORIDE 6 [hp_X]/1 N 20181231 69008-0026_5966babe-bb23-4ef1-e053-2991aa0ae8c5 69008-0026 HUMAN OTC DRUG Natrum Mur Natrum Muriaticum 12X TABLET ORAL 20170907 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SODIUM CHLORIDE 12 [hp_X]/1 N 20181231 69008-0027_5899d7ad-6366-522b-e053-2991aa0ac3be 69008-0027 HUMAN OTC DRUG Natrum Phos Natrum Phosphoricum TABLET ORAL 20170907 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 3 [hp_X]/1 N 20181231 69008-0028_5967058b-7f3b-b604-e053-2991aa0a13c2 69008-0028 HUMAN OTC DRUG Natrum Phos Natrum Phosphoricum 6X TABLET ORAL 20170907 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 6 [hp_X]/1 N 20181231 69008-0029_5967058b-7f50-b604-e053-2991aa0a13c2 69008-0029 HUMAN OTC DRUG Natrum Phos Natrum Phosphoricum 12X TABLET ORAL 20170907 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 12 [hp_X]/1 N 20181231 69008-0030_589a7955-4fdd-fd37-e053-2991aa0ae484 69008-0030 HUMAN OTC DRUG Natrum Sulph Natrum Sulphuricum TABLET ORAL 20170907 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SODIUM SULFATE 3 [hp_X]/1 N 20181231 69008-0031_5967058b-7f62-b604-e053-2991aa0a13c2 69008-0031 HUMAN OTC DRUG Natrum Sulph Natrum Sulphuricum TABLET ORAL 20170907 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SODIUM SULFATE 6 [hp_X]/1 N 20181231 69008-0032_5967058b-7f72-b604-e053-2991aa0a13c2 69008-0032 HUMAN OTC DRUG Natrum Sulph Natrum Sulphuricum 12X TABLET ORAL 20170907 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SODIUM SULFATE 12 [hp_X]/1 N 20181231 69008-0033_589a99e3-b3f8-42e7-e053-2991aa0a7642 69008-0033 HUMAN OTC DRUG Silicea Silicea TABLET ORAL 20170907 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SILICON DIOXIDE 3 [hp_X]/1 N 20181231 69008-0034_5962fe6b-0115-6bb7-e053-2991aa0a82f4 69008-0034 HUMAN OTC DRUG Silicea Silicea 6X TABLET ORAL 20170907 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SILICON DIOXIDE 6 [hp_X]/1 N 20181231 69008-0035_59634d13-51d6-62fb-e053-2a91aa0adc89 69008-0035 HUMAN OTC DRUG Silicea Silicea 12X TABLET ORAL 20170907 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SILICON DIOXIDE 12 [hp_X]/1 N 20181231 69008-4002_6141b3a6-fcb8-1a06-e053-2991aa0ac7c4 69008-4002 HUMAN OTC DRUG Combination Remedy 2 - Hemorrhoids Aesculus Hipposcastanum 1X, Aloe Socotrina 1X, Graphites 8X. Hamamelis Virginiana 3X, Nitricum Acidum 30X, Nux Vomica 1X, Silicea 8X SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories GRAPHITE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE; ALOE VERA LEAF; NITRIC ACID 8; 3; 1; 1; 8; 1; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4006_612d26d7-5058-e074-e053-2a91aa0a215b 69008-4006 HUMAN OTC DRUG Combination Remedy 6 - Upset Stomach Antimonium Crudum 6X, Antimonium Tartaricum 6X, Argentum Nitricum 6X, China Officinalis 3X, Kali Bichromicum 6X, Lycopodium 3X, Nux Vomica 3X, Phosphorus 6X SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories ANTIMONY TRISULFIDE; ANTIMONY POTASSIUM TARTRATE; SILVER NITRATE; CINCHONA OFFICINALIS BARK; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 6; 6; 6; 3; 6; 3; 3; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4008_612d55f3-5491-488c-e053-2991aa0ae025 69008-4008 HUMAN OTC DRUG Combination Remedy 8 - Eczema Arsenicum Album 6X, Berberis Vulgaris 6X, Dulcamara 6X, Mezereum 6X, Petroleum 6X, Rhus Toxicodendron 6X, Sulphur 6X SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SOLANUM DULCAMARA TOP; ARSENIC TRIOXIDE; KEROSENE; TOXICODENDRON PUBESCENS LEAF; BERBERIS VULGARIS ROOT BARK; DAPHNE MEZEREUM BARK; SULFUR 6; 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4009_612d55f3-549d-488c-e053-2991aa0ae025 69008-4009 HUMAN OTC DRUG Combination Remedy 9 - Indigestion Antimonium Crudum, Arsenicum Album, Carbo Vegetabilis , China Officinalis, Gentiana Lutea, Hydrastis Canadensis, Nux Vomica SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; GENTIANA LUTEA ROOT; GOLDENSEAL; STRYCHNOS NUX-VOMICA SEED; CINCHONA OFFICINALIS BARK 6; 3; 8; 3; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4010_612d55f3-5480-488c-e053-2991aa0ae025 69008-4010 HUMAN OTC DRUG Combination Remedy 10 - Menstrual Pain Aesculus Hipposcastanum, Caulophyllum, Crocus Sativus, Ferrum Phosphoricum , Hamamelis Virginiana, Kali Phosphoricum, Pulsatilla, Secale Cornutum SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SAFFRON; FERRUM PHOSPHORICUM; HORSE CHESTNUT; POTASSIUM PHOSPHATE, DIBASIC; CLAVICEPS PURPUREA SCLEROTIUM; PULSATILLA VULGARIS; CAULOPHYLLUM THALICTROIDES ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 4; 6; 2; 6; 6; 2; 2; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4011_612d55f3-5471-488c-e053-2991aa0ae025 69008-4011 HUMAN OTC DRUG Combination Remedy 11 - Healthy Heart Arsenicum Album, Cactus Grandiflorus, Digitalis Purpurea, Kali Phosphoricum , Kalmia Latifolia SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories DIGITALIS; POTASSIUM PHOSPHATE, DIBASIC; ARSENIC TRIOXIDE; SELENICEREUS GRANDIFLORUS STEM; KALMIA LATIFOLIA LEAF 2; 6; 6; 2; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4012_612d55e0-18d0-322b-e053-2991aa0a5008 69008-4012 HUMAN OTC DRUG Combination Remedy 12 - Irritated Watery Eye Belladonna, Euphrasia Officinalis, Ferrum Phosphoricum, Phosphorus, Pulsatilla, SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories FERRUM PHOSPHORICUM; PHOSPHORUS; ATROPA BELLADONNA; RUTA GRAVEOLENS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; EUPHRASIA STRICTA; PULSATILLA VULGARIS 6; 6; 2; 6; 30; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4016_612d55e0-18c1-322b-e053-2991aa0a5008 69008-4016 HUMAN OTC DRUG Combination Remedy 16 - Menopausal Complaints Cimicifuga Racemosa, Graphites, Sanguinaria Canadensis, Sepia, Sulphur SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SEPIA OFFICINALIS JUICE; GRAPHITE; SANGUINARIA CANADENSIS ROOT; BLACK COHOSH; SULFUR 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4019_612d55e0-18a9-322b-e053-2991aa0a5008 69008-4019 HUMAN OTC DRUG Combination Remedy 19 - Migraine Headache Gelsemium Semp, Ignatia Amara, Iris Versicolor, Sanguinaria, Spigelia SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories IRIS VERSICOLOR ROOT; SANGUINARIA CANADENSIS ROOT; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; SPIGELIA MARILANDICA ROOT 4; 4; 4; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4025_612cabf1-0882-3d4e-e053-2a91aa0aa85b 69008-4025 HUMAN OTC DRUG Combination Remedy 25 - Weakness from Blood Loss Cinnamomum, Erigeron Canandensis, Hamamelis Virginiana, Millefolium SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACHILLEA MILLEFOLIUM; CINNAMON; CONYZA CANADENSIS 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4026_612cc036-ca7c-73a1-e053-2991aa0a9c59 69008-4026 HUMAN OTC DRUG Combination Remedy 26 - Sore Throat Calcarea Fluorica, Calcarea Phosphorica, Hepar Sulphuris Calcereum, Kali Iodatum, Manganum Aceticum SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories CALCIUM SULFIDE; POTASSIUM IODIDE; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; MANGANESE ACETATE TETRAHYDRATE 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4028_612d26d7-504b-e074-e053-2a91aa0a215b 69008-4028 HUMAN OTC DRUG Combination Remedy 28 - Weak Memory Ambra Grisea, Anacardium Orientale, Baryta Carbonica, Kali Phosphoricum, Lachesis Mutus, Phosphoricum Acidum SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories BARIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; AMBERGRIS; PHOSPHORIC ACID; SEMECARPUS ANACARDIUM JUICE; LACHESIS MUTA VENOM 6; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4034_612cabf1-0866-3d4e-e053-2a91aa0aa85b 69008-4034 HUMAN OTC DRUG Combination Remedy 34 - Constipation Aloe Socotrina, Alumina, Bryonia Alba, Collinsonia Canadensis, Croton Tiglium, Nux Vomica SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories BRYONIA ALBA ROOT; COLLINSONIA CANADENSIS ROOT; ALOE VERA LEAF; STRYCHNOS NUX-VOMICA SEED; ALUMINUM OXIDE; CROTON TIGLIUM SEED 6; 6; 1; 1; 6; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4035_612cc036-ca55-73a1-e053-2991aa0a9c59 69008-4035 HUMAN OTC DRUG Combination Remedy 35 - Acne Pimples Antimonium Crudum, Arsenicum Iodatum, Berberis Aquifolium, Berberis Vulgaris, Bromium, Carbo Animalis, Hepar Sulphuris, Sulphur Iodatum SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SULFUR IODIDE; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; ANTIMONY TRISULFIDE; CARBO ANIMALIS; CALCIUM SULFIDE; ARSENIC TRIIODIDE; BROMINE 6; 1; 1; 30; 1; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4037_612cc036-ca6d-73a1-e053-2991aa0a9c59 69008-4037 HUMAN OTC DRUG Combination Remedy 37 - Low Back Pain Arnica Montana, Bryonia Alba, Calcarea Fluorica, Cobaltum Metallicum, Gnaphalium Polycephalum 6X, Hypericum Perforatum, Rhus Toxicodendron, Ruta Graveolens SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories BRYONIA ALBA ROOT; CALCIUM FLUORIDE; AMANITA MUSCARIA FRUITING BODY; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; ARNICA MONTANA; COBALT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP 6; 6; 6; 6; 1; 1; 6; 1; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4040_612cabf1-0855-3d4e-e053-2a91aa0aa85b 69008-4040 HUMAN OTC DRUG Combination Remedy 40 - Allergies Hay Fever Arsenicum Album, Calcarea Carbonica, Euphrasia Officinalis, Kali Bichromicum, Pulsatilla, Sabadilla, Sepia SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories EUPHRASIA STRICTA; POTASSIUM DICHROMATE; ARSENIC TRIOXIDE; SCHOENOCAULON OFFICINALE SEED; SEPIA OFFICINALIS JUICE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS 30; 30; 30; 6; 6; 30; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4041_612cc036-ca4b-73a1-e053-2991aa0a9c59 69008-4041 HUMAN OTC DRUG Combination Remedy 41 - Muscular Weakness Aconitum Napellus, Alfalfa, Avena Sativa, Causticum, Cocculus Indicus, Gelsemium Sempervirens, Plumbum Metallicum, Rhus Toxicodendron SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories AVENA SATIVA FLOWERING TOP; CAUSTICUM; ACONITUM NAPELLUS ROOT; GELSEMIUM SEMPERVIRENS ROOT; LEAD; ALFALFA; ANAMIRTA COCCULUS SEED; TOXICODENDRON PUBESCENS LEAF 2; 6; 6; 6; 6; 2; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4043_612cc036-ca30-73a1-e053-2991aa0a9c59 69008-4043 HUMAN OTC DRUG Combination Remedy 43 - Urinary Incontinence Bed Wetting Causticum, Equisetum Hyemale, Kreosotum, Sepia 30X, Sulphur, Zincum Metallicum SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories WOOD CREOSOTE; SEPIA OFFICINALIS JUICE; CAUSTICUM; ZINC; EQUISETUM HYEMALE; SULFUR 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4045_612cabf1-0845-3d4e-e053-2a91aa0aa85b 69008-4045 HUMAN OTC DRUG Combination Remedy 45 - Kidney Health Berberis Vulgaris, Benzoicum Acidum, Cantharis, Lycopodium Clavatum, Pareira Brava, Pulsatilla, SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories LYTTA VESICATORIA; LYCOPODIUM CLAVATUM SPORE; BERBERIS VULGARIS ROOT BARK; PULSATILLA VULGARIS; SARSAPARILLA; BENZOIC ACID; CHONDRODENDRON TOMENTOSUM ROOT; TURPENTINE OIL 1; 1; 1; 1; 1; 6; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4051_612cb238-7b4c-67f5-e053-2a91aa0ac827 69008-4051 HUMAN OTC DRUG Combination Remedy 50 - Warts Antimonium Crudum, Causticum, Dulcamara, Nitricum Acidum, Sabina, Thuja Occidentalis SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories SOLANUM DULCAMARA TOP; NITRIC ACID; ANTIMONY TRISULFIDE; THUJA OCCIDENTALIS LEAFY TWIG; CAUSTICUM; JUNIPERUS SABINA LEAF 6; 30; 30; 1; 6; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4054_612d55f3-54a7-488c-e053-2991aa0ae025 69008-4054 HUMAN OTC DRUG Combination Remedy 4 - Energy Boost Calcarea Sulphurica, Calcium Iodatum, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Phosphoricum, Natrum Phosphoricum, Natrum Muriaticum SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories TRIBASIC CALCIUM PHOSPHATE; CALCIUM IODIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM CHLORIDE; FERRUM PHOSPHORICUM; POTASSIUM PHOSPHATE, DIBASIC, TRIHYDRATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6; 3; 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4055_612dc3bb-1239-06ad-e053-2991aa0a5ef0 69008-4055 HUMAN OTC DRUG Combo Remedy 5 - Nausea Vomiting Aethusa Cynapium, Cocculus Indicus, Colchicum, Ipecacuanha, Lobelia Inflata, Veratrum Album SOLUTION/ DROPS ORAL 20171119 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic VERATRUM ALBUM ROOT; COLCHICUM AUTUMNALE BULB; IPECAC; LOBELIA INFLATA; AETHUSA CYNAPIUM; ANAMIRTA COCCULUS SEED 1; 12; 12; 1; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4064_612d2bd5-63e2-fcbc-e053-2a91aa0a6112 69008-4064 HUMAN OTC DRUG Combination Remedy 14 - Diarrhea Aloe Socotrina, Bryonia Alba, Chamomilla Q, Colocynthis, Ipecacuanha 6X, Nux Vomica, Phosphoricum Acidum, Veratrum Album SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; ALOE VERA LEAF; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; BRYONIA ALBA ROOT; IPECAC; VERATRUM ALBUM ROOT 1; 6; 6; 3; 1; 6; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4068_612d55e0-18b5-322b-e053-2991aa0a5008 69008-4068 HUMAN OTC DRUG Combination Remedy 18 - Skin Detox Arsenicum Album, Berberis Vulgaris, Calcarea Sulphurica, Echinacea, Hydrocotyle, Sarsaparilla, Sulphur, Thuja Occidentalis, Urtica Urens SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories ECHINACEA ANGUSTIFOLIA; CENTELLA ASIATICA; ARSENIC TRIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; BERBERIS VULGARIS ROOT BARK; SARSAPARILLA ROOT; URTICA URENS 1; 1; 3; 3; 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69008-4070_612d2bd5-63bc-fcbc-e053-2a91aa0a6112 69008-4070 HUMAN OTC DRUG Combination Remedy 20 - Insomnia Coffea Cruda, Hyoscyamus Niger, Ignatia Amara, Passiflora Incarnata, Valeriana Officinalis SOLUTION/ DROPS ORAL 20171115 UNAPPROVED HOMEOPATHIC Warsan Homoeopathic Laboratories STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; ARABICA COFFEE BEAN; HYOSCYAMUS NIGER; VALERIAN 1; 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69013-001_b956e2e1-999a-47ac-bcc0-ec248e7a3851 69013-001 HUMAN OTC DRUG Always Triple BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140527 OTC MONOGRAPH FINAL part352 Elishacoy Co., Inc. TITANIUM DIOXIDE; ZINC OXIDE 5; .5 g/50g; g/50g E 20171231 69013-002_b704a7f9-e572-49ac-9083-8bb2c29e5dc1 69013-002 HUMAN OTC DRUG Premium Gold Mineral BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Elishacoy Co., Inc. TITANIUM DIOXIDE; ZINC OXIDE 5; 3 g/50g; g/50g E 20171231 69013-003_d04d33fe-55f8-41dd-ae9d-88ed636e1d57 69013-003 HUMAN OTC DRUG Time Machine BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Elishacoy Co., Inc. TITANIUM DIOXIDE; ZINC OXIDE 3; 2 g/30g; g/30g E 20171231 69013-004_b8ca76a3-adab-4ff9-a376-fa6e5a5250a2 69013-004 HUMAN OTC DRUG Always Nuddy CC Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140528 OTC MONOGRAPH FINAL part352 Elishacoy Co., Inc. TITANIUM DIOXIDE; ZINC OXIDE 4; 1 g/50g; g/50g E 20171231 69013-005_a5111aeb-fd1d-4219-a95a-d1b818075562 69013-005 HUMAN OTC DRUG Always Perfect CC Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140529 OTC MONOGRAPH FINAL part352 Elishacoy Co., Inc. TITANIUM DIOXIDE; ZINC OXIDE 5; 3 g/50g; g/50g E 20171231 69013-006_5a65f5b6-ceff-3ca3-e053-2a91aa0a4499 69013-006 HUMAN OTC DRUG ElishaCoy Moist Up Super Hyalurone GLYCERIN LOTION TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 10.2 g/100mL N 20181231 69013-007_5a6eb2ed-47e8-2099-e053-2a91aa0adbb0 69013-007 HUMAN OTC DRUG ElishaCoy Moist Up Brightening CapsuleEssence GLYCERIN LIQUID TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 2 g/100mL N 20181231 69013-008_5a72a264-9252-5356-e053-2991aa0aaaa8 69013-008 HUMAN OTC DRUG ElishaCoy Moist Up Hyalurone Ampoule Toner GLYCERIN LIQUID TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 4.102 g/100mL N 20181231 69013-009_5a72a264-9254-5356-e053-2991aa0aaaa8 69013-009 HUMAN OTC DRUG ElishaCoy Moist Up Super Hyalurone Ampoule Serum GLYCERIN LIQUID TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 10 g/100mL N 20181231 69013-010_5a72a264-9262-5356-e053-2991aa0aaaa8 69013-010 HUMAN OTC DRUG ElishaCoy Moist Up Super Hyalurone GLYCERIN CREAM TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 2 g/100g N 20181231 69013-011_5a738a3a-0ce0-711e-e053-2991aa0a039f 69013-011 HUMAN OTC DRUG ElishaCoy Skin Refining Snail Mask GLYCERIN LIQUID TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 8 g/100g N 20181231 69013-012_5a738a3a-0cee-711e-e053-2991aa0a039f 69013-012 HUMAN OTC DRUG ElishaCoy Skin Refining Snail Cleanser GLYCERIN LIQUID TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 12 g/100g N 20181231 69013-013_5a7314f8-4f4c-4472-e053-2a91aa0af16f 69013-013 HUMAN OTC DRUG ElishaCoy Skin Refining Snail adenosine CREAM TOPICAL 20170930 UNAPPROVED DRUG OTHER Elishacoy Co., Inc ADENOSINE .04 g/100g N 20181231 69013-014_5a790794-dc50-585a-e053-2991aa0ad3c6 69013-014 HUMAN OTC DRUG ElishaCoy Skin Refining Snail Essence GLYCERIN LIQUID TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 1 g/100mL N 20181231 69013-015_5ac2686c-ed85-8cb8-e053-2991aa0af9a4 69013-015 HUMAN OTC DRUG ElishaCoy Skin Refining Snail Skin glycerin LOTION TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 5 g/100mL N 20181231 69013-016_5a7980c2-8f87-21cb-e053-2a91aa0ada8d 69013-016 HUMAN OTC DRUG ElishaCoy Snail Hydrogel Mask GLYCERIN LIQUID TOPICAL 20170930 OTC MONOGRAPH FINAL part347 Elishacoy Co., Inc GLYCERIN 20 g/100g N 20181231 69013-017_5ac2686c-ed8e-8cb8-e053-2991aa0af9a4 69013-017 HUMAN OTC DRUG ElishaCoy Snail Hydrogel Eye glycerin PATCH TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 10 g/100g N 20181231 69013-018_5ac2686c-ed97-8cb8-e053-2991aa0af9a4 69013-018 HUMAN OTC DRUG ElishaCoy Skin Repairing Snail Eye Balm glycerin CREAM TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN .025 g/100g N 20181231 69013-019_5a85684c-0158-c508-e053-2991aa0a34b2 69013-019 HUMAN OTC DRUG ElishaCoy 24K Gold Mineral Essence glycerin LIQUID TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 10.87 g/100mL N 20181231 69013-021_5a857e36-fba9-3e97-e053-2991aa0a8767 69013-021 HUMAN OTC DRUG ElishaCoy Brightening Ampoule Solution Mask GLYCERIN LIQUID TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 4 g/100g N 20181231 69013-022_5a857e36-fbc3-3e97-e053-2991aa0a8767 69013-022 HUMAN OTC DRUG ElishaCoy Refreshing Ampoule Solution Mask GLYCERIN LIQUID TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 4 g/100g N 20181231 69013-023_5a85684c-0163-c508-e053-2991aa0a34b2 69013-023 HUMAN OTC DRUG ElishaCoy Revitalizing Ampoule Solution Mask GLYCERIN LIQUID TOPICAL 20170930 OTC MONOGRAPH NOT FINAL part347 Elishacoy Co., Inc GLYCERIN 2 g/100g N 20181231 69013-024_5a857e36-fbb6-3e97-e053-2991aa0a8767 69013-024 HUMAN OTC DRUG ElishaCoy Vita CapsuleCleanser glycerin LIQUID TOPICAL 20170930 OTC MONOGRAPH FINAL part347 Elishacoy Co., Inc GLYCERIN 15 g/100mL N 20181231 69013-025_5c53ed36-b814-10b9-e053-2a91aa0a597d 69013-025 HUMAN OTC DRUG ElishaCoy 24K Gold Mineral glycerin CREAM TOPICAL 20171025 OTC MONOGRAPH FINAL part347 Elishacoy Co., Inc GLYCERIN 5 g/100g N 20181231 69015-100_b0101700-c3ac-4ed0-8eaf-06b8deca2dd5 69015-100 HUMAN OTC DRUG ULTIMATE AQUA BLANC PROTECTIVE OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE LOTION TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 Racinne (Hong Kong) Limited OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 3.75; 2.5; 2; 1.5 mg/50mL; mg/50mL; mg/50mL; mg/50mL E 20171231 69015-110_b3bf2015-0b08-46a0-b3ab-87a80e952f12 69015-110 HUMAN OTC DRUG ULTIMATE AQUA BLANC PROTECTIVE 10mL OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE LOTION TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 Racinne (Hong Kong) Limited OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE .75; .5; .4; .3 mg/10mL; mg/10mL; mg/10mL; mg/10mL E 20171231 69016-001_e6cff231-ba97-4016-ab47-323461fb6d70 69016-001 HUMAN OTC DRUG Relief OTC antacid CALCIUM CARBONATE, POTASSIUM BICARBONATE, SODIUM BICARBONATE LIQUID ORAL 20140528 OTC MONOGRAPH FINAL part331 Tummy Company, Inc. CALCIUM CARBONATE; POTASSIUM BICARBONATE; SODIUM BICARBONATE 545; 905; 2110 mg/118mL; mg/118mL; mg/118mL E 20171231 69017-101_360b982c-9eb0-499b-abf9-6b4cc9c62f09 69017-101 HUMAN OTC DRUG ANTI-BLEMISH MATTE PRIMER SALICLYLIC ACID LOTION TOPICAL 20140101 OTC MONOGRAPH FINAL part333D Jouer Cosmetics LLC SALICYLIC ACID 1 mg/100mL E 20171231 69017-101_b8bbedb2-be19-4c9a-a470-93422c8dbcda 69017-101 HUMAN OTC DRUG ANTI-BLEMISH MATTE PRIMER SALICLYLIC ACID LOTION TOPICAL 20140101 OTC MONOGRAPH FINAL part333D Jouer Cosmetics LLC SALICYLIC ACID 1 mg/100mL E 20171231 69017-201_a8d1361d-9081-4c4e-8fa7-41d6aa0026a4 69017-201 HUMAN OTC DRUG MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 HAZEL ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3 mg/100mL; mg/100mL N 20181231 69017-202_8ced08a3-bb4f-4e59-a556-2b95f02c4a21 69017-202 HUMAN OTC DRUG MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 Nude ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3 mg/100mL; mg/100mL N 20181231 69017-203_9717e234-8533-4745-8582-f68ff372542f 69017-203 HUMAN OTC DRUG MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 BEIGE ROSE ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3 mg/100mL; mg/100mL N 20181231 69017-204_fe1cd8a0-3812-45f0-a099-12d19b738827 69017-204 HUMAN OTC DRUG MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 CHAMOMILE ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3 mg/100mL; mg/100mL N 20181231 69017-205_d1dcd94a-a0dc-4db0-9b21-d0a7f0ec475d 69017-205 HUMAN OTC DRUG MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 Linen ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3 mg/100mL; mg/100mL N 20181231 69017-206_76041780-8991-45b2-8b30-cd0c3f18689d 69017-206 HUMAN OTC DRUG MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 Porcelain ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 4.5; 3 mg/100mL; mg/100mL N 20181231 69017-301_361d845a-1901-4979-bb3f-3a6d2916c072 69017-301 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 BLUSH ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL N 20181231 69017-302_e198612f-3274-4e11-993f-892f7858f254 69017-302 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 BRONZED ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL N 20181231 69017-303_93320269-96df-43ee-b7d2-1551c9e253f8 69017-303 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 DEEP BRONZE ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL N 20181231 69017-304_629ee131-8f57-45ce-8778-50aa7d5d4cb7 69017-304 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 GLOW ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL N 20181231 69017-305_be7c3616-4e6d-4bad-a81d-09df69173732 69017-305 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 GOLDEN ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL N 20181231 69017-306_1a4ad9e0-97ea-4c58-9809-0b3be84dd05c 69017-306 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 OPAL ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL N 20181231 69017-307_574ab28c-41dd-42ad-a8ad-d5f462adc340 69017-307 HUMAN OTC DRUG LUMINIZING MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 20 PEARL ZINC OXIDE AND TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Jouer Cosmetics LLC TITANIUM DIOXIDE; ZINC OXIDE 5; 5 mg/100mL; mg/100mL N 20181231 69020-200_35287aa1-48f4-48fd-9ec2-39971c02c56f 69020-200 HUMAN OTC DRUG MakeSense Extra Strength Muscle Rub Menthol GEL TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part348 Cherry Hill Sales Co MENTHOL 2.5 g/100g E 20171231 69020-201_675f8ce3-c1dc-4767-9156-69cd0a805cf9 69020-201 HUMAN OTC DRUG MAKESENSE with Aloe Vera and Vitamin E Camphor Menthol CREAM TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part348 Cherry Hill Sales Co CAMPHOR (SYNTHETIC); MENTHOL 1; 1 g/100g; g/100g E 20171231 69020-202_3995a4be-fb88-32b4-e054-00144ff8d46c 69020-202 HUMAN OTC DRUG MAKESENSE First Aid Bacitracin Zinc Neomycin Polymyxin B Sulfate OINTMENT TOPICAL 20140615 OTC MONOGRAPH FINAL part333B Cherry Hill Sales Co BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g E 20171231 69020-203_732c95f3-363c-432c-95b5-0f2507191dca 69020-203 HUMAN OTC DRUG MakeSense Clotrimazole CREAM TOPICAL 20140615 OTC MONOGRAPH FINAL part333C Cherry Hill Sales Co CLOTRIMAZOLE 1 g/100g E 20171231 69020-204_3995a7dc-a245-1eeb-e054-00144ff88e88 69020-204 HUMAN OTC DRUG MAKESENSE MAXIMUM STRENGTH Hydrocortisone CREAM TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part348 Cherry Hill Sales Co HYDROCORTISONE 1 g/100g E 20171231 69020-205_08a315bb-41c8-4cc9-9754-ec3b3bb5e7d7 69020-205 HUMAN OTC DRUG MAKESENSE Phenylephrine Hydrochloride Zinc oxide CREAM TOPICAL 20140731 OTC MONOGRAPH FINAL part346 Cherry Hill Sales Co PHENYLEPHRINE HYDROCHLORIDE; ZINC OXIDE .25; 12.5 g/100g; g/100g E 20171231 69020-206_90caa440-ee24-40b9-9ea6-6e4003469c8c 69020-206 HUMAN OTC DRUG MAKESENSE Junior Pain Relief Benzocaine GEL TOPICAL 20140715 OTC MONOGRAPH NOT FINAL part356 Cherry Hill Sales Co BENZOCAINE 7.5 g/100g E 20171231 69020-207_dbb2fffb-9c0c-4df5-ac7e-b15a9f83e28a 69020-207 HUMAN OTC DRUG MAKESENSE Pain Relief Benzocaine GEL TOPICAL 20140715 OTC MONOGRAPH NOT FINAL part356 Cherry Hill Sales Co BENZOCAINE 20 g/100g E 20171231 69020-208_cd1f86f8-255a-480e-bc47-1cb177465eb8 69020-208 HUMAN OTC DRUG MakeSense Miconazole CREAM TOPICAL 20140715 OTC MONOGRAPH FINAL part333C Cherry Hill Sales Co MICONAZOLE NITRATE 2 g/100g E 20171231 69020-209_46674f2f-860b-44b2-8f74-75b9d9956d04 69020-209 HUMAN OTC DRUG MakeSense Feminine Anti-itch Benzocaine Benzalkonium chloride CREAM TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part348 Cherry Hill Sales Co BENZOCAINE; BENZALKONIUM CHLORIDE 5; 130 g/100g; mg/100g E 20171231 69020-210_b0528b58-df31-46c8-8b0b-b3bf03d0480e 69020-210 HUMAN OTC DRUG MAKESENSE First Aid Lidocaine Hydrochloride Phenol CREAM TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part333E Cherry Hill Sales Co LIDOCAINE HYDROCHLORIDE ANHYDROUS; PHENOL .5; .5 g/100g; g/100g E 20171231 69022-001_d72dfb3d-666b-48c0-a674-b7bf5ea65174 69022-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140601 UNAPPROVED MEDICAL GAS American Home Medical Equipment and Services, Inc. OXYGEN 99 L/100L E 20171231 69023-100_5ac0eadd-ce2d-47df-9f86-9513defd288e 69023-100 HUMAN OTC DRUG One Gel Sport Pain relieving Camphor (Synthetic) and Menthol GEL TOPICAL 20140704 OTC MONOGRAPH NOT FINAL part348 Phyto Creativ CAMPHOR (SYNTHETIC); MENTHOL 30; 22 mg/mL; mg/mL E 20171231 69024-001_0b235482-1c2b-4543-a887-fa6222e523d9 69024-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140601 UNAPPROVED MEDICAL GAS OxyPros Plus OXYGEN 99 L/100L E 20171231 69025-100_e23a06d9-5379-462e-9cb0-9462086c5f3d 69025-100 HUMAN PRESCRIPTION DRUG tenofovir disoproxil fumarate tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20180126 UNAPPROVED DRUG OTHER AIZANT DRUG RESEARCH SOLUTIONS PVT LTD TENOFOVIR DISOPROXIL FUMARATE 150 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 69025-101_e23a06d9-5379-462e-9cb0-9462086c5f3d 69025-101 HUMAN PRESCRIPTION DRUG tenofovir disoproxil fumarate tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20180126 UNAPPROVED DRUG OTHER AIZANT DRUG RESEARCH SOLUTIONS PVT LTD TENOFOVIR DISOPROXIL FUMARATE 200 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 69025-102_e23a06d9-5379-462e-9cb0-9462086c5f3d 69025-102 HUMAN PRESCRIPTION DRUG tenofovir disoproxil fumarate tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20180126 UNAPPROVED DRUG OTHER AIZANT DRUG RESEARCH SOLUTIONS PVT LTD TENOFOVIR DISOPROXIL FUMARATE 250 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 69025-103_e23a06d9-5379-462e-9cb0-9462086c5f3d 69025-103 HUMAN PRESCRIPTION DRUG tenofovir disoproxil fumarate tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20180126 UNAPPROVED DRUG OTHER AIZANT DRUG RESEARCH SOLUTIONS PVT LTD TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 69026-253_25570cb4-4f37-4e6d-bd46-5e3a80384573 69026-253 HUMAN OTC DRUG Beauty Counter Protect All over Sunscreen SPF30 Zinc Oxide EMULSION TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 Counter Brands LLC ZINC OXIDE 19 g/100mL N 20181231 69026-279_befff84d-3dcb-4f4f-a470-ef6e625765ee 69026-279 HUMAN OTC DRUG Beauty Counter Dew Skin Moisturizer Fair SPF 20 Zinc Oxide LOTION TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part352 Counter Brands, LLC ZINC OXIDE 14 g/100mL N 20181231 69026-280_1e268f6d-11e3-4b01-a78f-06a924683a3b 69026-280 HUMAN OTC DRUG Beauty Counter Dew Skin Moisturizer Light SPF 20 Zinc Oxide LOTION TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part352 Counter Brands, LLC ZINC OXIDE 14 g/100mL N 20181231 69026-281_ea283546-37af-4b34-945e-0791a731cc93 69026-281 HUMAN OTC DRUG Beauty Counter Dew Skin Moisturizer Medium SPF 20 Zinc Oxide LOTION TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part352 Counter Brands, LLC ZINC OXIDE 14 g/100mL N 20181231 69026-282_2aaebf59-b549-4dc7-a74c-41c82dcce664 69026-282 HUMAN OTC DRUG Beauty Counter Dew Skin Moisturizer Dark SPF 20 Zinc Oxide LOTION TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part352 Counter Brands, LLC ZINC OXIDE 14 g/100mL N 20181231 69026-284_9565841d-638d-4306-8df9-a826a04001a2 69026-284 HUMAN OTC DRUG Beauty Counter Dew Skin Moisturizer Deep SPF 20 Zinc Oxide LOTION TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part352 Counter Brands, LLC ZINC OXIDE 14 g/100mL N 20181231 69026-286_d8fcd651-ab8a-47a3-9476-89e0cfbba9c0 69026-286 HUMAN OTC DRUG Beauty Counter Protect - Sweet Tooth SPF30 Zinc Oxide STICK TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Counter Brands, LLC ZINC OXIDE 15.4 g/100g N 20181231 69026-287_21eb58c2-7f46-42e7-9bdd-7db7e8410896 69026-287 HUMAN OTC DRUG Beauty Counter Protect Lip SPF15 Zinc Oxide LIPSTICK TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Counter Brands, LLC ZINC OXIDE 8.05 g/100g N 20181231 69027-001_3d1f464c-e93b-0836-e054-00144ff8d46c 69027-001 HUMAN OTC DRUG Safesha Lavender Moisturizing Hand Sanitizer LIQUID TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333A Safesha, LLC ALCOHOL 56.07 1/56.071 E 20171231 69027-002_3d1f464c-e93b-0836-e054-00144ff8d46c 69027-002 HUMAN OTC DRUG Safesha Sweet Orange Moisturizing Hand Sanitizer LIQUID TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333A Safesha, LLC ALCOHOL 56.07 1/56.071 E 20171231 69027-003_3d1f464c-e93b-0836-e054-00144ff8d46c 69027-003 HUMAN OTC DRUG Safesha Unfragranced Moisturizing Hand Sanitizer LIQUID TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part333A Safesha, LLC ALCOHOL 56.07 1/56.071 E 20171231 69028-0001_e8feaaa2-329c-3a53-b52b-8e51dc3c8fab 69028-0001 HUMAN PRESCRIPTION DRUG Drainage Carduus mar., Cynara, Solidago, Taraxacum, Benzoicum ac., Berberis vulg., Bryonia, Cantharis, Carduus ben., Ceanothus, Chelidonium maj., Chionanthus. Cinchona, Dioscorea, Dolichos, Iris vers., Juniperus com., Nux vom., Ptelea, Uricum ac. LIQUID ORAL 20140929 UNAPPROVED HOMEOPATHIC Xymogen BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; URIC ACID; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 69031-004_bf403e5d-f445-4832-adbe-0d164238f06d 69031-004 HUMAN OTC DRUG Soothion Psoriasis and Seborrheic Dermatitis Formula Salicylic Acid LOTION TOPICAL 20150401 OTC MONOGRAPH FINAL part358H Electrolyzed Innovations, LLC SALICYLIC ACID 2 g/100g E 20171231 69031-005_7b3ad9f9-c79d-44d7-9bcf-42199c26a76d 69031-005 HUMAN OTC DRUG Soothion Acne Treatment Formula Salicylic Acid LOTION TOPICAL 20150401 OTC MONOGRAPH FINAL part333D Electrolyzed Innovations, LLC SALICYLIC ACID 1 g/100g E 20171231 69031-006_95e6edc7-8e60-47bb-b1df-99fb04622afa 69031-006 HUMAN OTC DRUG Soothion Antiseptic Hand Sanitizer Benzalkonium chlroide LOTION TOPICAL 20150331 OTC MONOGRAPH NOT FINAL part333A Electrolyzed Innovations, LLC BENZALKONIUM CHLORIDE .13 g/100g E 20171231 69033-001_22754c5b-532a-484c-9a61-50226d9d6767 69033-001 HUMAN OTC DRUG La mer Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part333E Five Star Beach Properties ALCOHOL 62 mL/100mL N 20181231 69034-001_8bc84124-769f-4436-8827-e7cdaa83b342 69034-001 HUMAN OTC DRUG kiwi crate Liquid Hand Triclosan SOAP TOPICAL 20140606 OTC MONOGRAPH NOT FINAL part333E Kiwi Crate TRICLOSAN .3 g/100mL N 20181231 69036-110_67df3c55-a2b0-4185-8a0d-18754cdae920 69036-110 HUMAN OTC DRUG LORTUSS LQ Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 20140801 OTC MONOGRAPH FINAL part341 Sallus Laboratories, LLC DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 6.25; 30 mg/5mL; mg/5mL E 20171231 69036-120_41999ae8-18fc-49a0-a55c-ffa00f353ddd 69036-120 HUMAN OTC DRUG LORTUSS DM Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride LIQUID ORAL 20140614 OTC MONOGRAPH FINAL part341 Sallus Laboratories, LLC DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PSEUDOEPHEDRINE HYDROCHLORIDE 15; 6.25; 30 mg/5mL; mg/5mL; mg/5mL E 20171231 69036-130_ec543c14-8427-4659-bcc0-3cdcd149ba81 69036-130 HUMAN OTC DRUG LORTUSS EX Codeine Phosphate, Guaifenesin, Pseudoephedrine Hydrochloride LIQUID ORAL 20140601 OTC MONOGRAPH FINAL part341 Sallus Laboratories, LLC CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 100; 30 mg/5mL; mg/5mL; mg/5mL CV E 20171231 69036-221_3121b4fa-3bd6-4020-9b4b-670b07e363df 69036-221 HUMAN PRESCRIPTION DRUG SALLUS Pain Relief Collection with Naproxen Naproxen KIT 20070701 ANDA ANDA078250 Sallus Laboratories, Llc E 20171231 69036-503_6f96a3de-40f5-4d0d-9a6c-3d7fcddfd77c 69036-503 HUMAN PRESCRIPTION DRUG LODINE etodolac TABLET, FILM COATED ORAL 20160901 ANDA ANDA075074 Sallus Laboratories, LLC ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69038-001_9ae3d963-c738-44a7-a097-17dc629eb335 69038-001 HUMAN OTC DRUG BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 FAIR 01 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; TITANIUM DIOXIDE 60; 20 mg/mL; mg/mL N 20181231 69038-002_10b0193f-ab85-4dfa-a7e4-3f09aa14a486 69038-002 HUMAN OTC DRUG BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 MEDIUM 02 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; TITANIUM DIOXIDE 60; 20 mg/mL; mg/mL N 20181231 69038-003_7a663802-c4ed-4d24-bfa5-fe1e9d76a3d2 69038-003 HUMAN OTC DRUG BURBERRY FRESH GLOW B.B. LUMINOUS SKIN PERFECTING BEAUTY BALM SUNSCREEN BROAD SPECTRUM SPF 20 DARK 03 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20140616 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; TITANIUM DIOXIDE 60; 20 mg/mL; mg/mL N 20181231 69038-004_616a2610-d7e1-74c3-e053-2a91aa0a49d5 69038-004 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Almond No. 43 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-005_616a2eb8-6502-13b1-e053-2a91aa0ad4f2 69038-005 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Beige No. 26 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-006_616a3261-688d-1dc8-e053-2991aa0a2c61 69038-006 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Camel No. 42 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-007_616a3261-689d-1dc8-e053-2991aa0a2c61 69038-007 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Chestnut No. 60 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-008_616a370e-f9d2-00ee-e053-2991aa0a9dbb 69038-008 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Dark Sable No. 36 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-009_616a0b42-4f88-5064-e053-2a91aa0a7163 69038-009 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Deep Brown No. 66 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-010_616a2eb8-6515-13b1-e053-2a91aa0ad4f2 69038-010 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Honey No. 32 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-011_616a2eb8-6526-13b1-e053-2a91aa0ad4f2 69038-011 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Mocha No. 64 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-012_616a3fd0-756c-15b5-e053-2a91aa0a013e 69038-012 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Ochre No. 20 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-013_616a2610-d843-74c3-e053-2a91aa0a49d5 69038-013 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Ochre Nude No. 12 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-014_616a2eb8-6537-13b1-e053-2a91aa0ad4f2 69038-014 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Porcelain No. 11 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-015_616a3fd0-757d-15b5-e053-2a91aa0a013e 69038-015 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Rosy Nude No. 31 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-016_616a3fd0-758e-15b5-e053-2a91aa0a013e 69038-016 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Warm Honey No. 38 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-017_616a3fd0-759f-15b5-e053-2a91aa0a013e 69038-017 HUMAN OTC DRUG Burberry Fresh Glow Foundation Luminous Fluid Warm Nude No. 34 OCTINOXATE CREAM TOPICAL 20141114 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE 70 mg/mL N 20181231 69038-018_616a4f12-4f4b-1c3c-e053-2a91aa0a839f 69038-018 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Almond No.43 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150620 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-019_616a437d-05de-ccfd-e053-2991aa0a5e6b 69038-019 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Beige No.26 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150621 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-020_616a526e-f187-34ab-e053-2a91aa0a86b3 69038-020 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Camel No.42 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150621 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-021_616a526e-f197-34ab-e053-2a91aa0a86b3 69038-021 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 15 Chestnut No.60 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150622 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-022_616a5a44-2f28-1ed0-e053-2991aa0a7b16 69038-022 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Dark Sable No.36 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-023_616a5f3a-9e07-4834-e053-2a91aa0a2406 69038-023 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 15 Deep Brown No.66 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-024_616a526e-f1a6-34ab-e053-2a91aa0a86b3 69038-024 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Honey No.32 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-025_d011dab4-8e1a-42c3-b4ea-606338f8665b 69038-025 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 15 Mocha No.64 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-026_62503376-016f-4b9d-990b-ad4da61b64a3 69038-026 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Ochre No.20 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-027_616a5f3a-9e18-4834-e053-2a91aa0a2406 69038-027 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Ochre Nude No.12 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-028_616a526e-f1b5-34ab-e053-2a91aa0a86b3 69038-028 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Porcelain No.11 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-029_616a5f3a-9e27-4834-e053-2a91aa0a2406 69038-029 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Rosy Nude No.31 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-030_616a526e-f1c8-34ab-e053-2a91aa0a86b3 69038-030 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Warm Honey No.38 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-031_616a5f3a-9e37-4834-e053-2a91aa0a2406 69038-031 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Warm Nude No.34 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20150623 OTC MONOGRAPH NOT FINAL part352 Burberry Limited AVOBENZONE; OCTINOXATE; OCTISALATE 30; 35; 40 mg/mL; mg/mL; mg/mL N 20181231 69038-032_244a364e-d567-03ef-e054-00144ff8d46c 69038-032 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Warm Nude OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151107 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-033_612e02a8-d397-3830-e053-2991aa0ad6a4 69038-033 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Dark Sable OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151107 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-034_612e02a8-d389-3830-e053-2991aa0ad6a4 69038-034 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Warm Honey OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151107 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-035_612e02a8-d37b-3830-e053-2991aa0ad6a4 69038-035 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Camel OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151107 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-036_612e02a8-d36d-3830-e053-2991aa0ad6a4 69038-036 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Almond OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151107 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-037_612e02a8-d35f-3830-e053-2991aa0ad6a4 69038-037 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF15 Chestnut OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151107 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-038_612e02a8-d351-3830-e053-2991aa0ad6a4 69038-038 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF15 Mocha OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151107 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-039_612e02a8-d343-3830-e053-2991aa0ad6a4 69038-039 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF15 Deep Brown OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151107 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-040_612e02a8-d3d3-3830-e053-2991aa0ad6a4 69038-040 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Porcelain OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151106 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-041_612e02a8-d3c5-3830-e053-2991aa0ad6a4 69038-041 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Ochre Nude OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151106 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-042_612e02a8-d3b5-3830-e053-2991aa0ad6a4 69038-042 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Ochre No.20 OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151106 OTC MONOGRAPH FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-043_612dc3bb-1247-06ad-e053-2991aa0a5ef0 69038-043 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Beige OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151107 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-044_612ddd25-ecb8-cb0a-e053-2991aa0a38ed 69038-044 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Rosy Nude OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151107 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69038-045_612e02a8-d3a5-3830-e053-2991aa0ad6a4 69038-045 HUMAN OTC DRUG Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen SPF20 Honey OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151107 OTC MONOGRAPH NOT FINAL part352 Burberry Limited OCTINOXATE; OCTISALATE 34.9; 40 mg/mL; mg/mL N 20181231 69039-101_5221e564-48c7-4405-b07b-d0da2e1d29b3 69039-101 HUMAN OTC DRUG Natural Sunscreen Broad Spectrum SPF 30 Baby Bum Zinc Oxide LOTION TOPICAL 20140626 OTC MONOGRAPH FINAL part352 Sun Bum LLC ZINC OXIDE 22 g/100mL E 20171231 69039-102_7bea8f85-15a3-4a30-bc2b-7f240e2588b3 69039-102 HUMAN OTC DRUG Sunscreen Stick Broad Spectrum SPF 30 Sunscreen baby Bum Zinc Oxide STICK TOPICAL 20140628 OTC MONOGRAPH FINAL part352 Sun Bum LLC ZINC OXIDE 20 g/100g E 20171231 69039-103_1cd63453-7d42-47a8-8821-d6ecfff3ac55 69039-103 HUMAN OTC DRUG Premium Natural Sunscreen Baby Bum 30 Zinc Oxide STICK TOPICAL 20150427 OTC MONOGRAPH FINAL part352 Sun Bum LLC ZINC OXIDE 20 g/100g E 20171231 69039-104_726d326f-2577-4015-91cc-3df9f6ab270b 69039-104 HUMAN OTC DRUG Premium Natural Sunscreen Loition Baby Bum Zinc Oxide CREAM TOPICAL 20150427 OTC MONOGRAPH FINAL part352 Sun Bum LLC ZINC OXIDE 20 g/100mL E 20171231 69039-200_32a75826-2504-4350-e054-00144ff88e88 69039-200 HUMAN OTC DRUG Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 Pomegranate AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE STICK TOPICAL 20160512 OTC MONOGRAPH NOT FINAL part352 Sun Bum LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 2; 15; 7.5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 69039-201_32a72677-4e4c-6548-e054-00144ff8d46c 69039-201 HUMAN OTC DRUG Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 Pink Grapefruit AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE STICK TOPICAL 20160512 OTC MONOGRAPH NOT FINAL part352 Sun Bum LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 2; 15; 7.5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 69039-202_32a75826-2510-4350-e054-00144ff88e88 69039-202 HUMAN OTC DRUG Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 Mango AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE STICK TOPICAL 20160512 OTC MONOGRAPH NOT FINAL part352 Sun Bum LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 2; 15; 7.5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 69039-203_32a75826-251c-4350-e054-00144ff88e88 69039-203 HUMAN OTC DRUG Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 Key Lime AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE STICK TOPICAL 20160512 OTC MONOGRAPH NOT FINAL part352 Sun Bum LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 2; 15; 7.5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 69039-204_32a75826-252a-4350-e054-00144ff88e88 69039-204 HUMAN OTC DRUG Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 Coconut AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE STICK TOPICAL 20160512 OTC MONOGRAPH NOT FINAL part352 Sun Bum LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 2; 15; 7.5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 69039-205_32a72677-4e3d-6548-e054-00144ff8d46c 69039-205 HUMAN OTC DRUG Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 Banana AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE STICK TOPICAL 20160512 OTC MONOGRAPH NOT FINAL part352 Sun Bum LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 2; 15; 7.5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 69039-206_31662309-99ba-2c9f-e054-00144ff8d46c 69039-206 HUMAN OTC DRUG Signature Face/Clear High Performance Sunscreen Broad Spectrum SPF 30 HOMOSALATE, OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20160426 OTC MONOGRAPH NOT FINAL part352 Sun bum LLC HOMOSALATE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 70; 75; 75; 40; 70 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69039-207_321bef3e-9d71-1207-e054-00144ff8d46c 69039-207 HUMAN OTC DRUG Sun Bum Premium Sunscreen Face Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE STICK TOPICAL 20160426 OTC MONOGRAPH NOT FINAL part352 Sun bum LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 20; 150; 75; 50 mg/g; mg/g; mg/g; mg/g N 20181231 69039-208_5799925b-ac4d-a901-e053-2991aa0a6480 69039-208 HUMAN OTC DRUG SPF 30 Signature Premium Endurance Sunscreen OCTINOXATE, OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20170825 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 75; 75; 80 mg/mL; mg/mL; mg/mL N 20181231 69039-209_5799925b-ac5e-a901-e053-2991aa0a6480 69039-209 HUMAN OTC DRUG SPF 50 Signature Premium Endurance Sunscreen OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20170825 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 75; 50; 70; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-210_5799925b-ac6e-a901-e053-2991aa0a6480 69039-210 HUMAN OTC DRUG SPF 50 Signature Premium Endurance Tinted Face OCTINOXATE, TITANIUM DIOXIDE STICK TOPICAL 20170824 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC OCTINOXATE; TITANIUM DIOXIDE 30; 228.5 mg/g; mg/g N 20181231 69039-211_6159a386-8ac3-202c-e053-2a91aa0ad5cf 69039-211 HUMAN OTC DRUG Sun Bum SPF 15 Moisturizing Tanning AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE OIL TOPICAL 20170824 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-212_6159a699-d78a-56e1-e053-2991aa0ac41b 69039-212 HUMAN OTC DRUG Sun Bum SPF 15 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170824 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 50; 20; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-213_6159a986-069b-fddb-e053-2991aa0aef90 69039-213 HUMAN OTC DRUG Sun Bum SPF 15 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170825 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 50; 20; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-214_6159a986-06ad-fddb-e053-2991aa0aef90 69039-214 HUMAN OTC DRUG Sun Bum SPF 15 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170825 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 50; 20; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-215_615975c5-6e93-13ea-e053-2991aa0a06e1 69039-215 HUMAN OTC DRUG Sun Bum SPF 30 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170826 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 30; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-216_6159a699-d7a8-56e1-e053-2991aa0ac41b 69039-216 HUMAN OTC DRUG Sun Bum SPF 30 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170826 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 30; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-217_6159a699-d7b7-56e1-e053-2991aa0ac41b 69039-217 HUMAN OTC DRUG Sun Bum SPF 30 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170826 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 50; 30; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-218_6159a699-d7c6-56e1-e053-2991aa0ac41b 69039-218 HUMAN OTC DRUG Sun Bum SPF 50 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170826 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-219_6159a386-8ae4-202c-e053-2a91aa0ad5cf 69039-219 HUMAN OTC DRUG Sun Bum SPF 50 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170826 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-220_615992e6-69e8-3b26-e053-2991aa0ad374 69039-220 HUMAN OTC DRUG Sun Bum SPF 50 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170826 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-221_615992e6-69f7-3b26-e053-2991aa0ad374 69039-221 HUMAN OTC DRUG Sun Bum SPF 70 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170826 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-222_6159e6e0-6c6e-3e90-e053-2a91aa0a72cb 69039-222 HUMAN OTC DRUG Sun Bum SPF 70 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170826 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-223_6159dff2-b8b1-492d-e053-2991aa0ab4d1 69039-223 HUMAN OTC DRUG Sun Bum SPF 70 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION TOPICAL 20170824 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-224_6159dff2-b8c1-492d-e053-2991aa0ab4d1 69039-224 HUMAN OTC DRUG Sun Bum SPF 15 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20170826 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 60; 50; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-225_6159cceb-d87f-2dcf-e053-2991aa0a2934 69039-225 HUMAN OTC DRUG Sun Bum SPF 30 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20170826 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 37.5 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-226_6159a386-8af5-202c-e053-2a91aa0ad5cf 69039-226 HUMAN OTC DRUG Sun Bum SPF 50 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20170826 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 150; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-227_6159eea6-ebcd-5cc4-e053-2a91aa0afa2f 69039-227 HUMAN OTC DRUG Sun Bum SPF 70 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY TOPICAL 20170826 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-250_6159a386-8b04-202c-e053-2a91aa0ad5cf 69039-250 HUMAN OTC DRUG Sun Bum Face 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20171005 OTC MONOGRAPH NOT FINAL part352 SUN BUM, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-251_615a0c9a-bbbb-5cc0-e053-2a91aa0a9385 69039-251 HUMAN OTC DRUG Sun Bum Clear Zinc SPF50 Sunscreen OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE CREAM TOPICAL 20171005 OTC MONOGRAPH NOT FINAL part352 SUN BUM, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 75; 50; 100; 70 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69039-255_615a1916-aff1-4287-e053-2a91aa0a739e 69039-255 HUMAN OTC DRUG Baby Bum SPF50 Mineral Sunscreen ZINC OXIDE CREAM TOPICAL 20171011 OTC MONOGRAPH NOT FINAL part352 Sun Bum, LLC ZINC OXIDE 200 mg/mL N 20181231 69039-550_b079c52d-f86d-4799-bc1d-9ceb4fe34644 69039-550 HUMAN OTC DRUG Sun Bum 50 Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 2.75% Oxybenzone 6.00% LOTION TOPICAL 20120223 OTC MONOGRAPH NOT FINAL part352 Sun Bum LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 2.75; 6 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 69039-551_739dca98-fceb-45f9-b0d2-eaf2e4429860 69039-551 HUMAN OTC DRUG SunBum SPF 15 Avobenzone 2.00% Homosalate 5.00% Octisalate 2.00% Octocrylene 1.85% Oxybenzone 3.00% LOTION TOPICAL 20140112 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 2; 1.85; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-552_a450dcbc-2595-4256-9041-fe758c72e8c4 69039-552 HUMAN OTC DRUG SunBum SPF 30 Avobenzone 3.00% Homosalate 5.00% Octisalate 3.00% Octocrylene 2.75% Oxybenzone 4.00% LOTION TOPICAL 20111002 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 3; 2.75 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-553_a63b743c-2362-4d3b-b8fc-2887e520617e 69039-553 HUMAN OTC DRUG SunBum SPF 70 Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 2.80% Oxybenzone 6.00% LOTION TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.8; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-554_323811cf-264a-4066-be46-5706d56ab142 69039-554 HUMAN OTC DRUG SunBum SPF 30 Avobenzone 3.00% Homosalate 10.00% Octisalate 3.00% Octocrylene 2.75% Oxybenzone 3.00% SPRAY TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 3; 2.75; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-555_dbe40648-1e7b-4659-a616-47b3d9ef2d7c 69039-555 HUMAN OTC DRUG SunBum SPF 15 Avobenzone 2.00% Homosalate 6.00% Octisalate 2.00% Octocrylene 1.85% Oxybenzone 2.00% SPRAY TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 6; 2; 1.85; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-556_e71a5a86-4918-49d6-b188-4e954548fadb 69039-556 HUMAN OTC DRUG SunBum SPF 70 Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 4% Oxybenzone 6% SPRAY TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 4; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-557_ee004f19-f5ce-4f7e-8280-6de4a738f3ac 69039-557 HUMAN OTC DRUG SunBum SPF 30 Octinoxate - 7.50% Octocrylene - 7.50% Zinc Oxide - 8.00% LOTION TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part352 Sun Bum OCTINOXATE; OCTOCRYLENE; ZINC OXIDE 7.5; 7.5; 2.75 g/100mL; g/100mL; g/100mL N 20181231 69039-558_1b0c02e2-f973-4933-8da0-3eb0b5e00a48 69039-558 HUMAN OTC DRUG SunBum SPF 50 Octinoxate - 7.50% Octisalate - 5.00% Octocrylene - 7.00% Zinc Oxide - 10.00% LOTION TOPICAL 20150122 OTC MONOGRAPH NOT FINAL part352 Sun Bum OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 7.5; 5; 7; 10 g/100mL; g/100mL; g/100mL; 1/100mL N 20181231 69039-559_2a2eae98-efeb-4b3e-9ce7-6ad972364280 69039-559 HUMAN OTC DRUG SunBum SPF 50 Octisalate - 5.00% Octinoxate - 7.50% Oxybenzone - 6.00% Zinc Oxide - 7.00% CREAM TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part352 Sun Bum OCTISALATE; OCTINOXATE; OXYBENZONE; ZINC OXIDE 5; 7.5; 6; 7 g/100mL; g/100mL; g/100mL; 1/100mL N 20181231 69039-560_e4f37603-d1a2-4668-af82-5f1695ac9b4b 69039-560 HUMAN OTC DRUG SunBum SPF 50 Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 2.75% Oxybenzone 6.00% SPRAY TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 4; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-561_6f1e982d-9ff3-4894-85ba-54ee310f88e6 69039-561 HUMAN OTC DRUG Sunscreen SPF 15 Sun Bum Avobenzone 2.0% Homosalate 5.0% Octisalate 2.0% Octocrylene 10.0% LOTION TOPICAL 20170116 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 5; 2; 10 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-562_e35852c9-620f-4155-bbb7-97ca5133c4be 69039-562 HUMAN OTC DRUG Sunscreen SPF 30 Sun Bum Avobenzone 3.0% Homosalate 5.0% Octisalate 3.0% Octocrylene 10.0% LOTION TOPICAL 20170116 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 5; 3; 10 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-563_43844c14-75b5-49ff-a66f-dbd933fdc830 69039-563 HUMAN OTC DRUG Sunscreen SPF 30 Sun Bum Avobenzone 3.0% Homosalate 6.0% Octisalate 5.0% Octocrylene 2.0% SPRAY TOPICAL 20170315 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 6; 5; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-564_4341e3c7-d48b-41f7-a0a0-eb8be543def0 69039-564 HUMAN OTC DRUG Sunscreen SPF 50 Sun Bum Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0% Octocrylene 10.0% LOTION TOPICAL 20170116 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-565_cdf210d5-0549-48bc-ae5d-83c0e894a4f3 69039-565 HUMAN OTC DRUG Sunscreen SPF 70 Sun Bum Avobenzone 3.0% Homosalate 10.0% Octinoxate 5.0% Octisalate 5.0% Octocrylene 10.0% LOTION TOPICAL 20170315 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OCTINOXATE 3; 10; 5; 10; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-566_e2e545f0-c47a-400c-8b1e-52b81a0b48c2 69039-566 HUMAN OTC DRUG Sunscreen SPF 30 Sun Bum Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 3.75% SPRAY TOPICAL 20170315 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 3.75 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-567_101eddaf-71a9-4db8-8fbd-26c2e9fc7325 69039-567 HUMAN OTC DRUG Sunscreen SPF 50 Sun Bum Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 7.00% SPRAY TOPICAL 20161215 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-568_6e903852-a244-44a2-86fb-90bca01c9d96 69039-568 HUMAN OTC DRUG Sunscreen SPF 70 Sun Bum Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 10.00% SPRAY TOPICAL 20161215 OTC MONOGRAPH NOT FINAL part352 Sun Bum AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 10; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69039-600_60debdc6-1001-0da2-e053-2a91aa0a0542 69039-600 HUMAN OTC DRUG Sun Bum SPF 30 Watermelon AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE STICK TOPICAL 20170124 OTC MONOGRAPH NOT FINAL part352 Sun bum LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 20; 150; 75; 50 mg/g; mg/g; mg/g; mg/g N 20191231 69043-004_1429d5e8-7746-456c-9aad-32503c424429 69043-004 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150529 ANDA ANDA203974 Cronus Pharma LLC METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 69043-005_1429d5e8-7746-456c-9aad-32503c424429 69043-005 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20150529 ANDA ANDA203974 Cronus Pharma LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 69043-006_bc9c338c-1fc7-4bc2-a357-a78e433cbe9d 69043-006 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 Cronus Pharma LLC CEFPODOXIME PROXETIL 100 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 69043-007_bc9c338c-1fc7-4bc2-a357-a78e433cbe9d 69043-007 HUMAN PRESCRIPTION DRUG CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL TABLET, FILM COATED ORAL 20070611 ANDA ANDA065370 Cronus Pharma LLC CEFPODOXIME PROXETIL 200 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 69043-010_1b5de94f-973a-4b5a-91d7-45e05be78650 69043-010 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Cronus Pharma LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 69043-011_1b5de94f-973a-4b5a-91d7-45e05be78650 69043-011 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Cronus Pharma LLC SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 69044-123_249c55d1-b693-4466-93f8-12f3835fde4c 69044-123 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140612 UNAPPROVED MEDICAL GAS OXYGEN UTAH OXYGEN 210 mL/L E 20171231 69047-001_11f4dd9c-4dc1-41b9-be80-220568b72e45 69047-001 HUMAN OTC DRUG Youth Cell Day Cream Broad Spectrum SPF-15 Sunscreen (50 ml) SPF 15 Cream CREAM TOPICAL 20131016 OTC MONOGRAPH FINAL part352 Iluminage Beauty, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 5.994; 3; 2.4; 3 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 69047-001_fabf51b3-fc51-407f-82f7-6c4704a89775 69047-001 HUMAN OTC DRUG Youth Cell Day Broad Spectrum SPF-15 Sunscreen Avobenzone, Octinoxate, Octisalate, and Octocrylene CREAM TOPICAL 20131016 OTC MONOGRAPH FINAL part352 Iluminage Beauty, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 6; 3; 2.4; 3 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 69049-001_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-001 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-002_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-002 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-003_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-003 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-004_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-004 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-005_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-005 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-006_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-006 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-007_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-007 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-008_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-008 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-009_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-009 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-010_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-010 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-011_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-011 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-012_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-012 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-013_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-013 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-014_38741f1c-b276-4a36-b0ff-25e3f8ae9d94 69049-014 HUMAN OTC DRUG KIKO MILANO UNLIMITED FOUNDATION OCTINOXATE and TITANIUM DIOXIDE EMULSION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. OCTINOXATE; TITANIUM DIOXIDE .70434; 1.08108 g/30mL; g/30mL N 20181231 69049-015_b25d94b1-bb9f-4bfc-aee1-77cc4c8b6f88 69049-015 HUMAN OTC DRUG KIKO MILANO BRIGHT LIFT DAY AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.527; 3.054; 1.0689 g/50mL; g/50mL; g/50mL N 20181231 69049-016_a080d1ba-fac4-479a-9628-7cc4ce29835e 69049-016 HUMAN OTC DRUG KIKO MILANO BRIGHT LIFT MATTE AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5075; 3.015; 1.05525 g/50mL; g/50mL; g/50mL N 20181231 69049-017_44cff8c8-f7c4-4083-a425-83ab32dd225c 69049-017 HUMAN OTC DRUG KIKO MILANO SUBLIME YOUTH DAY AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.5075; 3.015; 1.05525 g/50mL; g/50mL; g/50mL N 20181231 69049-018_be051d67-6647-4e80-a60f-bcc7d75d4d5b 69049-018 HUMAN OTC DRUG KIKO MILANO HYDRA PRO DAY AVOBENZONE, OCTINOXATE, and OCTOCRYLENE CREAM TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 KIKO USA, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.4955; 2.991; 1.04685 g/50mL; g/50mL; g/50mL N 20181231 69049-019_c4a99c68-6c6b-49e9-9bfa-208db9b61a09 69049-019 HUMAN OTC DRUG KIKO MILANO SHINE REFINE SPOT SALICYLIC ACID CREAM TOPICAL 20161220 OTC MONOGRAPH FINAL part333D KIKO USA, Inc. SALICYLIC ACID .15105 g/15mL N 20181231 69051-300_db46447e-542a-449a-935c-badd03a6242b 69051-300 HUMAN PRESCRIPTION DRUG IMPAVIDO miltefosine CAPSULE ORAL 20151029 NDA NDA204684 Profounda, Inc. MILTEFOSINE 50 mg/1 Antileishmanial [EPC] N 20181231 69054-210_41bc18d9-9498-41c4-b84e-5bb6d2d52543 69054-210 HUMAN PRESCRIPTION DRUG Ocuvel Ocuvel CAPSULE ORAL 20141105 UNAPPROVED DRUG OTHER Adler-Stern Pharmaceuticals, LLC FOLIC ACID; ASCORBIC ACID; ALPHA-TOCOPHEROL ACETATE; ZINC OXIDE; COPPER; LUTEIN; ZEAXANTHIN 1; 500; 400; 80; 2; 10; 2 mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 69054-211_856ddba0-ef2e-43d7-bde6-682c15a5086a 69054-211 HUMAN PRESCRIPTION DRUG Ocuvel Ocuvel CAPSULE ORAL 20141201 UNAPPROVED DRUG OTHER Adler-Stern Pharmaceuticals, LLC FOLIC ACID; ASCORBIC ACID; ALPHA-TOCOPHEROL ACETATE; ZINC OXIDE; COPPER; LUTEIN; ZEAXANTHIN .5; 250; 200; 40; 1; 5; 1 mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE] E 20171231 69058-010_f5da32dd-4fb0-4033-85c9-f860f40f5d9d 69058-010 HUMAN OTC DRUG CATRIN DIAMOND MINERAL FOUNDATION Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Nature&Bio Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 1.38; 1.17 g/9g; g/9g N 20181231 69058-020_cdb1813d-a3f3-483c-9195-f1ca5edd1cd1 69058-020 HUMAN OTC DRUG UV NATURAL 100 MINERAL SUNKILL RX 2.5g Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Nature&Bio Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE .44; .43 g/2.5g; g/2.5g N 20181231 69058-030_badc1c10-8407-4c0e-a0f9-3934b2b8aa68 69058-030 HUMAN OTC DRUG UV NATURAL 100 MINERAL SUNKILL RX 3g Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Nature&Bio Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE .53; .51 g/3g; g/3g N 20181231 69058-040_962527ce-c583-41a8-ba4d-c631f3ae0b7a 69058-040 HUMAN OTC DRUG UV NATURAL 100 MINERAL SUNKILL RX 12g Zinc Oxide , Titanium Dioxide POWDER TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Nature&Bio Co., Ltd. ZINC OXIDE; TITANIUM DIOXIDE 2.14; 2.07 g/12g; g/12g N 20181231 69058-100_e9f9069f-2ea8-466c-bef2-a08c7e73cc13 69058-100 HUMAN OTC DRUG MAXCLINIC CIRMAGE LIFTING ADENOSINE, GLYCYRRHIZA GLABRA STICK TOPICAL 20161101 UNAPPROVED DRUG OTHER N&B LAB.Co.Ltd ADENOSINE; GLYCYRRHIZA GLABRA .009; .01 g/23g; g/23g N 20181231 69058-200_3c771f13-8c54-401a-9369-376869f2d661 69058-200 HUMAN OTC DRUG MAXCLINIC MIRACLINIC CONTOUR ING OBJECT Niacinamide, Adenosine PATCH TOPICAL 20161101 UNAPPROVED DRUG OTHER N&B LAB.Co.Ltd NIACINAMIDE; ADENOSINE .48; .009 g/24g; g/24g N 20181231 69058-300_cd91e943-9c8a-41e8-b054-325365aac0e9 69058-300 HUMAN OTC DRUG MAXCLINIC DEEP AND DEEPER MESO CHANGE AMPOULE Niacinamide, Adenosine LIQUID TOPICAL 20161220 UNAPPROVED DRUG OTHER N&B LAB.Co.Ltd NIACINAMIDE; ADENOSINE .14; .002 g/7mL; g/7mL N 20181231 69058-400_73d4c0d5-6461-4b4f-a3f7-c022b66f49da 69058-400 HUMAN OTC DRUG MAXCLINIC HYALURONIC MESO CHANGE ROLLER HYALURONIC ACID PATCH TOPICAL 20161220 UNAPPROVED DRUG OTHER N&B LAB.Co.Ltd HYALURONIC ACID 67.9 mg/70mg N 20181231 69058-500_68285a79-4573-4583-ab60-10c9762bf62b 69058-500 HUMAN OTC DRUG MAXCLINIC DEEP AND DEEPER MESO CHANGE AMPOULE Niacinamide, Adenosine LIQUID TOPICAL 20161220 UNAPPROVED DRUG OTHER N&B LAB.Co.Ltd NIACINAMIDE; ADENOSINE .14; .002 g/7mL; g/7mL N 20181231 69058-600_a0949aa6-6c53-4f22-a529-98d237fba0d8 69058-600 HUMAN OTC DRUG MAXCLINIC HYALURONIC MESO CHANGE ROLLER HYALURONIC ACID PATCH TOPICAL 20161220 UNAPPROVED DRUG OTHER N&B LAB.Co.Ltd HYALURONIC ACID 67.9 mg/70mg N 20181231 69061-101_b341f1e2-214f-4db6-8129-f5c07fe05afa 69061-101 HUMAN OTC DRUG FUNGUS MD TOLNAFTATE LIQUID TOPICAL 20140718 OTC MONOGRAPH FINAL part333C Orly International Inc TOLNAFTATE 1 g/100mL E 20171231 69065-001_24aa1424-21f1-465e-a047-84ab3569b959 69065-001 HUMAN OTC DRUG Gadis Lip Moisturizer SPF15 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20140806 OTC MONOGRAPH NOT FINAL part352 Gadis Ingenious Gadgets Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g E 20171231 69067-100_4d1ff5b8-e25a-4b54-9d45-f51b788b8b07 69067-100 HUMAN OTC DRUG Acetaminophen ACETAMINOPHEN LIQUID ORAL 20160309 OTC MONOGRAPH NOT FINAL part343 Foxland Pharmaceuticals, Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 69067-240_63d0e824-234a-4325-8d45-f28f8277ab0e 69067-240 HUMAN PRESCRIPTION DRUG Carbinoxamine Maleate CARBINOXAMINE MALEATE TABLET ORAL 20171218 ANDA ANDA207484 Foxland Pharmaceuticals, Inc. CARBINOXAMINE MALEATE 6 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 69069-102_201d2c2e-72a1-4fff-8409-cfd5d33bd768 69069-102 HUMAN OTC DRUG INFINITE ALOE SKIN CARE ALLANTOIN, COLLOIDAL OATMEAL LOTION TOPICAL 20170526 OTC MONOGRAPH FINAL part347 Economical Solutions, Inc. (DBA INFINITE ALOE) ALLANTOIN; OATMEAL .5; .07 g/100mL; g/100mL N 20181231 69070-001_e218123a-f368-451b-9ef2-8a7a7c15b08c 69070-001 HUMAN OTC DRUG Shao Lin Pain Relief Plaster Menthol, Methyl Salicylate PLASTER TRANSDERMAL 20100501 OTC MONOGRAPH NOT FINAL part348 Zhejiang Dingtai Pharmaceutical Co.; Ltd MENTHOL; METHYL SALICYLATE .5; .5 g/100g; g/100g N 20181231 69072-010_a08f95b5-ff62-42e9-96a9-3416122b27aa 69072-010 HUMAN OTC DRUG MOIST MOISTURE BB Titanium Dioxide, Zinc Oxide, OCTINOXATE CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SEINDNI CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 3.5; 3.5; 3.5 mg/50mL; mg/50mL; mg/50mL N 20181231 69072-020_3a69a0a2-0616-4bac-97f3-bfa992d262a2 69072-020 HUMAN OTC DRUG MOIST MOISTURE CC OCTINOXATE, Titanium Dioxide, OCTISALATE CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SEINDNI CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 2.01; 1.26; .75 mg/30mL; mg/30mL; mg/30mL N 20181231 69072-030_28218ed9-e7b2-4085-872a-c98253595931 69072-030 HUMAN OTC DRUG O2 Bubble Pack Wash Dimethicone LIQUID TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE 1 mg/100mL N 20181231 69072-040_d4c971f5-7975-4c26-aa43-594a7ff868b8 69072-040 HUMAN OTC DRUG MOIST MOISTURE Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE 3 mg/300mL N 20181231 69072-050_bcba3d1d-4499-4abc-9b81-85267e8d15f7 69072-050 HUMAN OTC DRUG MOIST MOISTURE EYE Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE .35 g/35g N 20181231 69072-060_cf0ec5a4-c021-49ea-ae13-d3e0ff89c1c3 69072-060 HUMAN OTC DRUG MOIST MOISTURE ESSENCE FACE MASK Dimethicone PATCH TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE .22 mg/22mL N 20181231 69072-070_d0b64b13-0efb-4f06-9c27-2f3a16bf8418 69072-070 HUMAN OTC DRUG askinDr MOIST MOISTURE Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE .6 mg/60g N 20181231 69072-080_19fa1cec-fc91-4b53-94f9-5ab2e381526a 69072-080 HUMAN OTC DRUG MOIST MOISTURE SKIN TONER Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE 2 mg/200mL N 20181231 69072-090_5945b7a3-9546-41c3-bdee-224d48958e61 69072-090 HUMAN OTC DRUG MOIST MOISTURE EMULSION Dimethicone CREAM TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE 2 mg/200mL N 20181231 69072-100_5f12105a-b7ad-402c-bbf3-c5882f039ffc 69072-100 HUMAN OTC DRUG HYALURONIC ACID COLLAGEN ESSENCE MASK Dimethicone PATCH TOPICAL 20140601 OTC MONOGRAPH FINAL part347 SEINDNI CO., LTD. DIMETHICONE .22 mg/22mL N 20181231 69075-001_5c6cacbf-93f7-4873-8e30-4ee312e577b7 69075-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140801 NDA NDA205865 VirtAir Inc. OXYGEN 990 mL/L N 20181231 69076-146_3ca5f00f-6682-42c8-ab73-b8875bf43bbc 69076-146 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20150201 ANDA ANDA075090 Quinn Pharmaceuticals, LLC ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 69076-475_2fd6bf62-dc6c-45cd-873a-70b63c71353f 69076-475 HUMAN PRESCRIPTION DRUG GLYCOPYRROLATE GLYCOPYRROLATE TABLET ORAL 20150302 ANDA ANDA091182 Quinn Pharmaceuticals, LLC GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 69076-476_2fd6bf62-dc6c-45cd-873a-70b63c71353f 69076-476 HUMAN PRESCRIPTION DRUG GLYCOPYRROLATE GLYCOPYRROLATE TABLET ORAL 20150302 ANDA ANDA091182 Quinn Pharmaceuticals, LLC GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 69076-500_42b67574-5bdb-478a-8c98-0bfd96fca12e 69076-500 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160601 ANDA ANDA202167 Quinn Pharmaceuticals, LLC LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69076-750_42b67574-5bdb-478a-8c98-0bfd96fca12e 69076-750 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160601 ANDA ANDA202167 Quinn Pharmaceuticals, LLC LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69076-913_752460b7-86dc-42dc-85fe-3aae07788f51 69076-913 HUMAN PRESCRIPTION DRUG Mercaptopurine Mercaptopurine TABLET ORAL 20161005 NDA AUTHORIZED GENERIC NDA009053 Quinn Pharmaceuticals, LLC MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 69077-101_8c6dba80-1cb5-4448-b9d3-531da8aabf24 69077-101 HUMAN OTC DRUG SILKEN HAND SANITIZER ETHYL ALCOHOL GEL TOPICAL 20140628 OTC MONOGRAPH NOT FINAL part333E COSMOBEAUTI LABORATORIES & MANUFACTURING, INC. ALCOHOL 62 mL/100mL N 20181231 69078-101_d79b2722-55a7-4233-a524-051e6ed9d2c7 69078-101 HUMAN OTC DRUG LACURA FACE CARE Q10 DAY SPF-15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20141212 OTC MONOGRAPH FINAL part352 MAXIM Markenprodukte GmbH & Co. KG AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 8; 4; 1.5 g/100g; g/100g; g/100g; g/100g N 20181231 69081-002_cfa551d5-e173-4559-b0ae-4d281936a3b6 69081-002 HUMAN OTC DRUG Gloves in a Bottle with SPF15 Octinoxate, octisalate, homosalate LOTION TOPICAL 20140707 OTC MONOGRAPH FINAL part352 Gloves in a Bottle, Inc OCTINOXATE; OCTISALATE; HOMOSALATE .07; .05; .03 g/g; g/g; g/g N 20181231 69082-500_a5b5a968-7af5-4ac9-90d4-56cf5a19b4aa 69082-500 HUMAN OTC DRUG BAC-D Antibacterial Wound and Skin care Benzalkonium Chloride SPRAY TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part333A RDM Products, Inc BENZALKONIUM CHLORIDE .13 g/100mL E 20171231 69082-500_ac4016b2-8a98-47d8-a2ef-c3a387f87614 69082-500 HUMAN OTC DRUG BAC-D Antibacterial Wound and Skin care Benzalkonium Chloride SPRAY TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part333A RDM Products, Inc BENZALKONIUM CHLORIDE .13 g/100mL E 20171231 69082-600_fc9d1c32-f058-4f89-b6d0-1be4d98badea 69082-600 HUMAN OTC DRUG BAC-D Foaming Antibacterial Hand sanitizer Benzalkonium Chloride LIQUID TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part333A RDM Products, Inc BENZALKONIUM CHLORIDE .13 g/100mL E 20171231 69082-700_a17e1456-c093-4ec8-a827-c79625688d68 69082-700 HUMAN OTC DRUG BAC-D Foaming Antibacterial Wound sanitizer Benzalkonium Chloride LIQUID TOPICAL 20140812 OTC MONOGRAPH NOT FINAL part333A RDM Products, Inc BENZALKONIUM CHLORIDE .13 g/100mL E 20171231 69083-101_ee87aaf6-37a4-4193-8560-d7717f4ca4c1 69083-101 HUMAN OTC DRUG Seldicine (Massage Cream) CAMPHOR, MENTHOL CREAM TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part348 Orye Life Science Co., Ltd. CAMPHOR OIL; MENTHOL 1; 1 g/100g; g/100g N 20181231 69085-465_95ae4ecd-4f7e-471b-886d-f8ed8a2a82f2 69085-465 HUMAN OTC DRUG Omnicide Antimicrobial benzalkonium chloride GEL TOPICAL 20170401 20180401 OTC MONOGRAPH NOT FINAL part333A SteriWeb Medical, LLC BENZALKONIUM CHLORIDE .13 g/100g N 20181231 69086-1001_6b5ead19-c310-46f4-a237-013c4de4017d 69086-1001 HUMAN OTC DRUG Sensible SODIUM LAURYL SULFATE PASTE DENTAL 20140711 OTC MONOGRAPH NOT FINAL part356 Guardian Angel of Preventive Dentistry SODIUM LAURYL SULFATE 2 g/100g E 20171231 69088-101_aa6acc09-9ee0-445a-8d1c-63904bff94fa 69088-101 HUMAN OTC DRUG Personal Wash Cloths Benzalkonium chloride CLOTH TOPICAL 20140714 OTC MONOGRAPH NOT FINAL part333A Leading Age Supplies BENZALKONIUM CHLORIDE .0155 g/1 E 20171231 69089-101_1ae3422d-9b8e-4297-8ecd-bd0655a5e62f 69089-101 HUMAN OTC DRUG Personal Wash Cloths Benzalkonium chloride CLOTH TOPICAL 20140714 OTC MONOGRAPH NOT FINAL part333A Ginni Filaments Limited BENZALKONIUM CHLORIDE .0155 g/1 E 20171231 69090-0100_befbb401-5456-4e1b-82a6-8408f307d36e 69090-0100 HUMAN OTC DRUG SPF-30 BB Zinc Oxide LOTION TOPICAL 20140120 OTC MONOGRAPH FINAL part352 ZION HEALTH ZINC OXIDE 20 g/100mL E 20171231 69092-001_c6248bef-a477-465f-a1ba-023dc55a6c29 69092-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20140707 OTC MONOGRAPH NOT FINAL part333E Matrix Source USA, Inc ALCOHOL 62 mL/100mL N 20181231 69093-1001_af6bc443-664b-4fbc-878b-bc1a724eeb7d 69093-1001 HUMAN OTC DRUG Flex Power Cream GLYCERIN CREAM TOPICAL 20140703 OTC MONOGRAPH FINAL part347 FLEX-POWER KOREA INC GLYCERIN 4 g/100mL E 20171231 69094-226_616bfbf4-fa56-0956-e053-2a91aa0a24c6 69094-226 HUMAN OTC DRUG 1st RELIEF TOPICAL LIDOCAINE AND MENTHOL SPRAY TOPICAL 20141202 OTC MONOGRAPH NOT FINAL part348 1st Class Pharmaceuticals, Inc. LIDOCAINE; MENTHOL 40; 10 mg/mL; mg/mL N 20181231 69096-0100_1a5917aa-cddd-4225-b2df-f9e177533c0e 69096-0100 HUMAN OTC DRUG Linea Jose Ignacio Sunscreen Broad Spectrum SPF30 Avobenzone, Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20121210 OTC MONOGRAPH FINAL part352 Linea Jose Ignacio AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 15; 75; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 69097-112_93618003-21c5-4b03-a565-329c56f3c82c 69097-112 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET ORAL 20141120 ANDA ANDA077335 Cipla USA Inc. FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 69097-122_62105b56-6084-4b43-9f4c-26b65f002363 69097-122 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Cipla USA Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69097-123_62105b56-6084-4b43-9f4c-26b65f002363 69097-123 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Cipla USA Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69097-124_62105b56-6084-4b43-9f4c-26b65f002363 69097-124 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Cipla USA Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69097-125_62105b56-6084-4b43-9f4c-26b65f002363 69097-125 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Cipla USA Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69097-126_a11a9f00-6cdb-4621-819d-c77887264c2a 69097-126 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Cipla USA Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 69097-127_a11a9f00-6cdb-4621-819d-c77887264c2a 69097-127 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Cipla USA Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 69097-128_a11a9f00-6cdb-4621-819d-c77887264c2a 69097-128 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Cipla USA Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 69097-148_5cd06eba-4ddf-45dc-98d5-d2b79708ab44 69097-148 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Cipla USA Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 69097-149_5cd06eba-4ddf-45dc-98d5-d2b79708ab44 69097-149 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Cipla USA Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 69097-151_5cd06eba-4ddf-45dc-98d5-d2b79708ab44 69097-151 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Cipla USA Inc. LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 69097-152_5cd06eba-4ddf-45dc-98d5-d2b79708ab44 69097-152 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Cipla USA Inc. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 69097-153_70e2b19e-9bbf-4569-a3de-632030992f54 69097-153 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20100524 ANDA ANDA077135 Cipla USA Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 69097-154_70e2b19e-9bbf-4569-a3de-632030992f54 69097-154 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20100524 ANDA ANDA077135 Cipla USA Inc. VALACYCLOVIR HYDROCHLORIDE 1000 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 69097-155_7dc4a6a5-6ada-4c47-9e9b-65124b4eebc4 69097-155 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20070206 ANDA ANDA077162 Cipla USA Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69097-156_7dc4a6a5-6ada-4c47-9e9b-65124b4eebc4 69097-156 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20070206 ANDA ANDA077162 Cipla USA Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69097-157_7dc4a6a5-6ada-4c47-9e9b-65124b4eebc4 69097-157 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20070206 ANDA ANDA077162 Cipla USA Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69097-158_2fd5442e-aac8-4833-975f-b726a4c70d26 69097-158 HUMAN PRESCRIPTION DRUG MELOXICAM meloxicam TABLET ORAL 20060719 ANDA ANDA077929 Cipla USA Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69097-159_2fd5442e-aac8-4833-975f-b726a4c70d26 69097-159 HUMAN PRESCRIPTION DRUG MELOXICAM meloxicam TABLET ORAL 20060719 ANDA ANDA077929 Cipla USA Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69097-173_f8476423-eeb4-4ffd-9355-12d19a8f0ca7 69097-173 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20071231 ANDA ANDA077559 Cipla USA Inc. ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 2.5; .5 mg/3mL; mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 69097-181_d634142f-da4b-4d93-a302-de7c09a41ba3 69097-181 HUMAN PRESCRIPTION DRUG Rizatriptan benzoate Rizatriptan benzoate TABLET ORAL 20130326 ANDA ANDA077526 Cipla USA Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 69097-182_d634142f-da4b-4d93-a302-de7c09a41ba3 69097-182 HUMAN PRESCRIPTION DRUG Rizatriptan benzoate Rizatriptan benzoate TABLET ORAL 20150320 ANDA ANDA077526 Cipla USA Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 69097-183_f29e29da-ae5c-474b-b10e-678c18d90d58 69097-183 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA077904 Cipla USA Inc. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69097-184_f29e29da-ae5c-474b-b10e-678c18d90d58 69097-184 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA077904 Cipla USA Inc. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69097-185_f29e29da-ae5c-474b-b10e-678c18d90d58 69097-185 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20061023 ANDA ANDA077904 Cipla USA Inc. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69097-186_f29e29da-ae5c-474b-b10e-678c18d90d58 69097-186 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20160322 ANDA ANDA077904 Cipla USA Inc. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69097-195_304fa966-ae86-48a7-8785-0b96f20e82ee 69097-195 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20071231 ANDA ANDA078262 Cipla Limited GRANISETRON HYDROCHLORIDE .1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 69097-196_103adee4-f7c6-4ec9-acdc-ce5d93e2d0f1 69097-196 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080630 ANDA ANDA078258 Cipla USA Inc. GRANISETRON HYDROCHLORIDE 1 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 69097-197_103adee4-f7c6-4ec9-acdc-ce5d93e2d0f1 69097-197 HUMAN PRESCRIPTION DRUG GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTION INTRAVENOUS 20080630 ANDA ANDA078258 Cipla USA Inc. GRANISETRON HYDROCHLORIDE 4 mg/4mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 69097-223_9ddbe838-d25c-4467-a3cf-7f4ce82ec42e 69097-223 HUMAN PRESCRIPTION DRUG ALENDRONATE SODIUM Alendronate sodium TABLET ORAL 20080804 ANDA ANDA076768 Cipla USA Inc. ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 69097-224_9ddbe838-d25c-4467-a3cf-7f4ce82ec42e 69097-224 HUMAN PRESCRIPTION DRUG ALENDRONATE SODIUM Alendronate sodium TABLET ORAL 20080804 ANDA ANDA076768 Cipla USA Inc. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 69097-225_d06eb627-6dd7-4b7b-bb8d-249edb7a03f8 69097-225 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Cipla USA, Inc. DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 69097-226_d06eb627-6dd7-4b7b-bb8d-249edb7a03f8 69097-226 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Cipla USA, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 69097-227_2d708b1e-0332-48e0-893b-9957ad611668 69097-227 HUMAN PRESCRIPTION DRUG doxycycline hyclate doxycycline hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 Cipla USA, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 69097-228_837ab38f-155b-4317-b3f5-849a97580145 69097-228 HUMAN PRESCRIPTION DRUG Doxycycline DOXYCYCLINE POWDER, FOR SUSPENSION ORAL 20080716 ANDA ANDA065454 CIPLA USA, Inc DOXYCYCLINE 25 mg/5mL N 20181231 69097-263_98a2a3d4-f553-4d39-916e-ececd0ef8eb4 69097-263 HUMAN PRESCRIPTION DRUG CARVEDILOL carvedilol TABLET ORAL 20070905 ANDA ANDA077474 Cipla USA Inc. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 69097-264_98a2a3d4-f553-4d39-916e-ececd0ef8eb4 69097-264 HUMAN PRESCRIPTION DRUG CARVEDILOL carvedilol TABLET ORAL 20070905 ANDA ANDA077474 Cipla USA Inc. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 69097-265_98a2a3d4-f553-4d39-916e-ececd0ef8eb4 69097-265 HUMAN PRESCRIPTION DRUG CARVEDILOL carvedilol TABLET ORAL 20070905 ANDA ANDA077474 Cipla USA Inc. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 69097-266_98a2a3d4-f553-4d39-916e-ececd0ef8eb4 69097-266 HUMAN PRESCRIPTION DRUG CARVEDILOL carvedilol TABLET ORAL 20070905 ANDA ANDA077474 Cipla USA Inc. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 69097-269_e31d2f5e-7321-470a-9fca-a59eb4b94f99 69097-269 HUMAN PRESCRIPTION DRUG FAMCICLOVIR Famciclovir TABLET ORAL 20110321 ANDA ANDA078278 Cipla USA Inc. FAMCICLOVIR 125 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 69097-271_e31d2f5e-7321-470a-9fca-a59eb4b94f99 69097-271 HUMAN PRESCRIPTION DRUG FAMCICLOVIR Famciclovir TABLET ORAL 20110321 ANDA ANDA078278 Cipla USA Inc. FAMCICLOVIR 250 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 69097-272_e31d2f5e-7321-470a-9fca-a59eb4b94f99 69097-272 HUMAN PRESCRIPTION DRUG FAMCICLOVIR Famciclovir TABLET ORAL 20110321 ANDA ANDA078278 Cipla USA Inc. FAMCICLOVIR 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 69097-274_29b76e82-c9d2-4d76-9d41-da78c12b8360 69097-274 HUMAN PRESCRIPTION DRUG oxaliplatin oxaliplatin INJECTION INTRAVENOUS 20170210 ANDA ANDA208523 Cipla USA Inc. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 69097-275_dee07703-08d3-4fd4-9215-b6b0bbc40111 69097-275 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride Olopatadine Hydrochloride SOLUTION/ DROPS OPHTHALMIC 20170726 ANDA ANDA206046 Cipla USA Inc. OLOPATADINE HYDROCHLORIDE 1 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 69097-276_55de6b00-c17f-45c5-b872-3728116efa4f 69097-276 HUMAN PRESCRIPTION DRUG Olopatadine Hydrochloride Olopatadine Hydrochloride Ophthalmic Solution SOLUTION/ DROPS OPHTHALMIC 20171205 ANDA ANDA206087 Cipla USA Inc. OLOPATADINE 2 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 69097-282_f1f6bee7-9d42-4f76-a2dc-7de2b65912cc 69097-282 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 Cipla USA Inc. LEVOFLOXACIN 250 mg/1 N 20181231 69097-285_b0af838f-88bd-41e5-b23d-21ef37de2786 69097-285 HUMAN PRESCRIPTION DRUG Decitabine Decitabine INJECTION INTRAVENOUS 20171116 ANDA ANDA208601 Cipla USA Inc. DECITABINE 50 mg/10mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 69097-287_f1f6bee7-9d42-4f76-a2dc-7de2b65912cc 69097-287 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 Cipla USA Inc. LEVOFLOXACIN 750 mg/1 N 20181231 69097-289_f1f6bee7-9d42-4f76-a2dc-7de2b65912cc 69097-289 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 Cipla USA Inc. LEVOFLOXACIN 500 mg/1 N 20181231 69097-297_43bebed3-9eea-474d-81f3-03b72289cf55 69097-297 HUMAN PRESCRIPTION DRUG duloxetine duloxetine CAPSULE, DELAYED RELEASE ORAL 20151205 ANDA ANDA202336 Cipla USA Inc. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 69097-298_43bebed3-9eea-474d-81f3-03b72289cf55 69097-298 HUMAN PRESCRIPTION DRUG duloxetine duloxetine CAPSULE, DELAYED RELEASE ORAL 20151205 ANDA ANDA202336 Cipla USA Inc. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 69097-299_43bebed3-9eea-474d-81f3-03b72289cf55 69097-299 HUMAN PRESCRIPTION DRUG duloxetine duloxetine CAPSULE, DELAYED RELEASE ORAL 20151205 ANDA ANDA202336 Cipla USA Inc. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 69097-313_910253d1-6110-41c6-afcb-4428f98d309c 69097-313 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA078759 Cipla USA Inc. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 69097-314_910253d1-6110-41c6-afcb-4428f98d309c 69097-314 HUMAN PRESCRIPTION DRUG GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110725 ANDA ANDA078759 Cipla USA Inc. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 69097-318_31c209c4-1527-416d-bf61-59d51abb9bad 69097-318 HUMAN PRESCRIPTION DRUG Budesonide Inhalation Suspension Budesonide INHALANT ORAL 20171116 ANDA ANDA205710 Cipla USA Inc. BUDESONIDE .25 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69097-319_31c209c4-1527-416d-bf61-59d51abb9bad 69097-319 HUMAN PRESCRIPTION DRUG Budesonide Inhalation Suspension Budesonide INHALANT ORAL 20171116 ANDA ANDA205710 Cipla USA Inc. BUDESONIDE .5 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69097-321_31c209c4-1527-416d-bf61-59d51abb9bad 69097-321 HUMAN PRESCRIPTION DRUG Budesonide Inhalation Suspension Budesonide INHALANT ORAL 20171116 ANDA ANDA205710 Cipla USA Inc. BUDESONIDE 1 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69097-353_29b76e82-c9d2-4d76-9d41-da78c12b8360 69097-353 HUMAN PRESCRIPTION DRUG oxaliplatin oxaliplatin INJECTION INTRAVENOUS 20170210 ANDA ANDA208523 Cipla USA Inc. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 69097-361_31b4395e-4b5d-494d-b17e-65529ef451ee 69097-361 HUMAN PRESCRIPTION DRUG grisofulvin grisofulvin SUSPENSION ORAL 20170306 ANDA ANDA065354 Cipla USA Inc. GRISEOFULVIN 125 mg/5mL Decreased Mitosis [PE],Microtubule Inhibition [PE],Tubulin Inhibiting Agent [EPC] N 20181231 69097-362_5526e4ef-5b80-460a-b25f-08bc77435f85 69097-362 HUMAN PRESCRIPTION DRUG Abacavir and Lamivudine Abacavir and lamivudine TABLET, FILM COATED ORAL 20170328 ANDA ANDA091144 Cipla USA Inc. ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 69097-399_6343f712-ff09-4734-aa56-f0b47579462f 69097-399 HUMAN PRESCRIPTION DRUG ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTION INTRAVENOUS 20171027 ANDA ANDA210174 Cipla USA Inc. ZOLEDRONIC ACID 4 mg/100mL Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 69097-403_1c8001da-21e7-4f41-a38f-9c4ee04ecd30 69097-403 HUMAN PRESCRIPTION DRUG NEVIRAPINE NEVIRAPINE TABLET, EXTENDED RELEASE ORAL 20151015 ANDA ANDA206448 Cipla USA Inc. NEVIRAPINE 400 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 69097-420_48f6a05c-c5a2-4df4-b5d8-1e08c5db2a9a 69097-420 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20150923 ANDA ANDA207446 Cipla USA Inc. CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69097-421_48f6a05c-c5a2-4df4-b5d8-1e08c5db2a9a 69097-421 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20150923 ANDA ANDA207446 Cipla USA Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69097-422_48f6a05c-c5a2-4df4-b5d8-1e08c5db2a9a 69097-422 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20150923 ANDA ANDA207446 Cipla USA Inc. CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69097-423_48f6a05c-c5a2-4df4-b5d8-1e08c5db2a9a 69097-423 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20150923 ANDA ANDA207446 Cipla USA Inc. CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69097-425_a2f0adb2-6505-47bf-ac71-e15cd38434f3 69097-425 HUMAN PRESCRIPTION DRUG ENTECAVIR ENTECAVIR TABLET, FILM COATED ORAL 20161206 ANDA ANDA206872 Cipla USA Inc. ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 69097-426_a2f0adb2-6505-47bf-ac71-e15cd38434f3 69097-426 HUMAN PRESCRIPTION DRUG ENTECAVIR ENTECAVIR TABLET, FILM COATED ORAL 20161206 ANDA ANDA206872 Cipla USA Inc. ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 69097-431_cdecb9b2-7fa7-4803-8822-07e3125f2af8 69097-431 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20160901 ANDA ANDA207664 Cipla USA Inc. DARIFENACIN HYDROBROMIDE 7.5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 69097-432_cdecb9b2-7fa7-4803-8822-07e3125f2af8 69097-432 HUMAN PRESCRIPTION DRUG Darifenacin Darifenacin Hydrobromide TABLET, EXTENDED RELEASE ORAL 20160901 ANDA ANDA207664 Cipla USA Inc. DARIFENACIN HYDROBROMIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 69097-458_ec14dc1f-0a1f-43df-8b26-da4e32cb02b3 69097-458 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20161215 ANDA ANDA208709 Cipla USA Inc. FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 69097-459_ec14dc1f-0a1f-43df-8b26-da4e32cb02b3 69097-459 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20161215 ANDA ANDA208709 Cipla USA Inc. FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 69097-514_86599d71-3a0f-4f3f-8b32-263fdba12f2d 69097-514 HUMAN PRESCRIPTION DRUG Abacavir Abacavir TABLET, FILM COATED ORAL 20171121 ANDA ANDA078119 Cipla USA Inc. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 69097-533_2acdf28f-b0c0-430f-813f-2c75300e5763 69097-533 HUMAN PRESCRIPTION DRUG Tenofovir disoproxil fumarate Tenofovir disoproxil fumarate TABLET ORAL 20180126 ANDA ANDA078800 Cipla USA Inc. TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 69097-811_54f184de-ba3e-4db8-ae88-b4c06263df79 69097-811 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20160722 ANDA ANDA202764 Cipla USA Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69097-812_54f184de-ba3e-4db8-ae88-b4c06263df79 69097-812 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20160722 ANDA ANDA202764 Cipla USA Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69097-813_0aab3e2c-7053-4e36-95be-dcd3d0dd1271 69097-813 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Cipla USA Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69097-814_0aab3e2c-7053-4e36-95be-dcd3d0dd1271 69097-814 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Cipla USA Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69097-815_0aab3e2c-7053-4e36-95be-dcd3d0dd1271 69097-815 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Cipla USA Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69097-816_e4e7349c-c7e6-4c01-be61-90100c484981 69097-816 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20160722 ANDA ANDA079162 Cipla USA Inc. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69097-817_e4e7349c-c7e6-4c01-be61-90100c484981 69097-817 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20160722 ANDA ANDA079162 Cipla USA Inc. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69097-818_e4e7349c-c7e6-4c01-be61-90100c484981 69097-818 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20160722 ANDA ANDA079162 Cipla USA Inc. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69097-819_e4e7349c-c7e6-4c01-be61-90100c484981 69097-819 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20160722 ANDA ANDA079162 Cipla USA Inc. TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69097-821_9f38c73a-cca8-4453-b0f2-520d40610209 69097-821 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20161013 ANDA ANDA077836 Cipla USA Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 69097-822_995db8e2-af1b-4c26-8788-7d736315fe4c 69097-822 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20160722 ANDA ANDA077534 Cipla USA Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69097-823_995db8e2-af1b-4c26-8788-7d736315fe4c 69097-823 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20160722 ANDA ANDA077534 Cipla USA Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69097-824_995db8e2-af1b-4c26-8788-7d736315fe4c 69097-824 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20160722 ANDA ANDA077534 Cipla USA Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69097-825_b417137c-2a66-4136-843f-2e78924df807 69097-825 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene TABLET ORAL 20160629 ANDA ANDA090842 Cipla USA Inc. RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 69097-826_cf594afe-b2eb-470a-9b4b-e77438f9f6af 69097-826 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine TABLET ORAL 20160629 ANDA ANDA090294 Cipla USA Inc. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 69097-827_cf594afe-b2eb-470a-9b4b-e77438f9f6af 69097-827 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine TABLET ORAL 20160629 ANDA ANDA090294 Cipla USA Inc. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 69097-828_4d5399c0-8a0b-4140-bade-1a338866b769 69097-828 HUMAN PRESCRIPTION DRUG Quinapril and Hydrochlorothiazide 10/12.5 quinapril and Hydrochlorothiazide 10/12.5 TABLET ORAL 20160720 ANDA ANDA201356 Cipla USA Inc. QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69097-829_4d5399c0-8a0b-4140-bade-1a338866b769 69097-829 HUMAN PRESCRIPTION DRUG Quinapril and Hydrochlorothiazide 20/12.5 Quinapril and Hydrochlorothiazide 20/12.5 TABLET ORAL 20160720 ANDA ANDA201356 Cipla USA Inc. QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69097-831_4d5399c0-8a0b-4140-bade-1a338866b769 69097-831 HUMAN PRESCRIPTION DRUG Quinapril and Hydrochlorothiazide 20/25 Quinapril and Hydrochlorothiazide 20/25 TABLET ORAL 20160720 ANDA ANDA201356 Cipla USA Inc. QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69097-832_cf594afe-b2eb-470a-9b4b-e77438f9f6af 69097-832 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine TABLET ORAL 20160629 ANDA ANDA090294 Cipla USA Inc. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 69097-833_fdfe9a53-db3a-4f86-9a79-1933ccdb7bcd 69097-833 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Cipla USA Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69097-834_fdfe9a53-db3a-4f86-9a79-1933ccdb7bcd 69097-834 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Cipla USA Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69097-835_fdfe9a53-db3a-4f86-9a79-1933ccdb7bcd 69097-835 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Cipla USA Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69097-836_49f2ecf6-56c6-4e69-bcbf-908b7acf6f0a 69097-836 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160701 ANDA ANDA077955 Cipla USA Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 69097-837_49f2ecf6-56c6-4e69-bcbf-908b7acf6f0a 69097-837 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160701 ANDA ANDA077955 Cipla USA Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 69097-838_49f2ecf6-56c6-4e69-bcbf-908b7acf6f0a 69097-838 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20160701 ANDA ANDA077955 Cipla USA Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 69097-839_b1bc5d1c-af0b-46a3-b116-c980f3009dfb 69097-839 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20160722 ANDA ANDA078457 Cipla USA Inc. QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69097-841_b1bc5d1c-af0b-46a3-b116-c980f3009dfb 69097-841 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20160722 ANDA ANDA078457 Cipla USA Inc. QUINAPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69097-842_b1bc5d1c-af0b-46a3-b116-c980f3009dfb 69097-842 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20160722 ANDA ANDA078457 Cipla USA Inc. QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69097-843_b1bc5d1c-af0b-46a3-b116-c980f3009dfb 69097-843 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20160722 ANDA ANDA078457 Cipla USA Inc. QUINAPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69097-844_58bd255d-cff2-4397-a3e2-d1d126480be5 69097-844 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride extended release Alfuzosin Hydrochloride TABLET ORAL 20160630 ANDA ANDA090284 Cipla USA Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 69097-845_7d5e3bad-7f85-4e2b-81c5-7981c456e45f 69097-845 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 Cipla USA Inc. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 69097-846_7d5e3bad-7f85-4e2b-81c5-7981c456e45f 69097-846 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20160722 ANDA ANDA090478 Cipla USA Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 69097-847_d8f104ce-ce6f-445c-b731-3ecde37f233a 69097-847 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram TABLET, FILM COATED ORAL 20160616 ANDA ANDA078604 Cipla USA Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69097-848_d8f104ce-ce6f-445c-b731-3ecde37f233a 69097-848 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram TABLET, FILM COATED ORAL 20160616 ANDA ANDA078604 Cipla USA Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69097-849_d8f104ce-ce6f-445c-b731-3ecde37f233a 69097-849 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram TABLET, FILM COATED ORAL 20160616 ANDA ANDA078604 Cipla USA Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69097-851_0778e9f1-b341-448c-ba26-cfa4370e8123 69097-851 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20160705 ANDA ANDA091432 Cipla USA Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69097-852_0778e9f1-b341-448c-ba26-cfa4370e8123 69097-852 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20160705 ANDA ANDA091432 Cipla USA Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69097-853_dbeda03f-df79-4b67-8933-83ec511eb887 69097-853 HUMAN PRESCRIPTION DRUG naproxen naproxen TABLET ORAL 20160705 ANDA ANDA091305 Cipla USA Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69097-854_dbeda03f-df79-4b67-8933-83ec511eb887 69097-854 HUMAN PRESCRIPTION DRUG naproxen naproxen TABLET ORAL 20160705 ANDA ANDA091305 Cipla USA Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69097-855_dbeda03f-df79-4b67-8933-83ec511eb887 69097-855 HUMAN PRESCRIPTION DRUG naproxen naproxen TABLET ORAL 20160705 ANDA ANDA091305 Cipla USA Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69097-856_ed3defd0-feb0-456e-a911-bd46ba608a74 69097-856 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril TABLET ORAL 20160616 ANDA ANDA077222 Cipla USA Inc. FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69097-857_ed3defd0-feb0-456e-a911-bd46ba608a74 69097-857 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril TABLET ORAL 20160616 ANDA ANDA077222 Cipla USA Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69097-858_ed3defd0-feb0-456e-a911-bd46ba608a74 69097-858 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril TABLET ORAL 20160616 ANDA ANDA077222 Cipla USA Inc. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69097-859_2798a208-1c96-4cb8-b6be-8db2df645764 69097-859 HUMAN PRESCRIPTION DRUG Terbinafine Terbinafine TABLET ORAL 20160627 ANDA ANDA077533 Cipla USA Inc. TERBINAFINE HYDROCHLORIDE 250 1/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 69097-861_2e6a08d2-d909-4059-ae2f-6991e9cb9ee1 69097-861 HUMAN PRESCRIPTION DRUG zonisamide zonisamide CAPSULE ORAL 20160713 ANDA ANDA077869 Cipla USA Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 69097-862_448d2837-de39-4087-af93-0a261c293e6d 69097-862 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20160726 ANDA ANDA203135 Cipla USA Inc., CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 69097-863_8f04a6e0-2b32-4abe-a7d7-8fe70b5d936d 69097-863 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20160720 ANDA ANDA204284 Cipla USA Inc. ZOLMITRIPTAN 2.5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 69097-864_8f04a6e0-2b32-4abe-a7d7-8fe70b5d936d 69097-864 HUMAN PRESCRIPTION DRUG Zolmitriptan Zolmitriptan TABLET, FILM COATED ORAL 20160720 ANDA ANDA204284 Cipla USA Inc. ZOLMITRIPTAN 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 69097-865_039a7714-1195-451f-bee3-977361cd7296 69097-865 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20160722 ANDA ANDA204339 Cipla USA Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 69097-866_039a7714-1195-451f-bee3-977361cd7296 69097-866 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20160722 ANDA ANDA204339 Cipla USA Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 69097-867_4d401693-53ab-4d63-9f25-39fe5ddca2a1 69097-867 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20160223 ANDA ANDA203455 Cipla USA Inc. NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 69097-868_4d401693-53ab-4d63-9f25-39fe5ddca2a1 69097-868 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20160223 ANDA ANDA203455 Cipla USA Inc. NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 69097-869_4d401693-53ab-4d63-9f25-39fe5ddca2a1 69097-869 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20160223 ANDA ANDA203455 Cipla USA Inc. NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 69097-875_7095c889-3c7f-45c6-90c7-ea39c49eac08 69097-875 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20160829 ANDA ANDA206556 CIPLA USA INC., BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 69097-876_7095c889-3c7f-45c6-90c7-ea39c49eac08 69097-876 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20160829 ANDA ANDA206556 CIPLA USA INC., BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 69097-877_3a57d758-31c1-4b9f-8d61-d0df5a858def 69097-877 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE (SR) Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160725 ANDA ANDA206674 Cipla USA Inc., BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 69097-878_3a57d758-31c1-4b9f-8d61-d0df5a858def 69097-878 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE (SR) Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160725 ANDA ANDA206674 Cipla USA Inc., BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 69097-879_3a57d758-31c1-4b9f-8d61-d0df5a858def 69097-879 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE (SR) Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160725 ANDA ANDA206674 Cipla USA Inc., BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 69097-893_7417be1e-f536-4018-9d1a-ffcb25eac1b4 69097-893 HUMAN PRESCRIPTION DRUG Sevelamer carbonate SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20171026 ANDA ANDA203860 Cipla USA Inc. SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 69097-894_525cb07a-2b81-486a-a073-e2ef490c03e9 69097-894 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20170330 ANDA ANDA207378 Cipla USA Inc., FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 69097-895_525cb07a-2b81-486a-a073-e2ef490c03e9 69097-895 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20170330 ANDA ANDA207378 Cipla USA Inc., FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 69097-896_525cb07a-2b81-486a-a073-e2ef490c03e9 69097-896 HUMAN PRESCRIPTION DRUG Fenofibrate fenofibrate CAPSULE ORAL 20170330 ANDA ANDA207378 Cipla USA Inc., FENOFIBRATE 200 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 69097-897_52bdd978-0e60-4f48-b72e-616ee0d53dc3 69097-897 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160804 ANDA ANDA205519 Cipla USA Inc., ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69097-898_52bdd978-0e60-4f48-b72e-616ee0d53dc3 69097-898 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160804 ANDA ANDA205519 Cipla USA Inc., ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69097-899_52bdd978-0e60-4f48-b72e-616ee0d53dc3 69097-899 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160804 ANDA ANDA205519 Cipla USA Inc., ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69097-911_52bdd978-0e60-4f48-b72e-616ee0d53dc3 69097-911 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20160804 ANDA ANDA205519 Cipla USA Inc., ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69097-912_01261fec-a983-4f77-b8d1-a57229d051ab 69097-912 HUMAN PRESCRIPTION DRUG Trospium Chloride Trospium Chloride TABLET, FILM COATED ORAL 20160923 ANDA ANDA091688 CIPLA USA INC., TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 69097-913_9e07dedd-3aaa-4c0b-84fc-d98b65884558 69097-913 HUMAN PRESCRIPTION DRUG omeprazole sodium bicarbonate omeprazole sodium bicarbonate CAPSULE ORAL 20170130 ANDA ANDA207476 Cipla USA Inc. OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69097-914_9e07dedd-3aaa-4c0b-84fc-d98b65884558 69097-914 HUMAN PRESCRIPTION DRUG omeprazole sodium bicarbonate omeprazole sodium bicarbonate CAPSULE ORAL 20170130 ANDA ANDA207476 Cipla USA Inc. OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69097-915_8c90da76-d928-486c-92d1-576e8f4d137d 69097-915 HUMAN PRESCRIPTION DRUG FLUTAMIDE FLUTAMIDE CAPSULE ORAL 20160921 ANDA ANDA075780 Cipla USA Inc. FLUTAMIDE 125 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] N 20181231 69097-925_23b2fe07-6fc6-49ca-bbb2-97b4bbf30e2d 69097-925 HUMAN PRESCRIPTION DRUG amantadine hydrochloride amantadine hydrochloride TABLET ORAL 20170131 ANDA ANDA207571 Cipla USA Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 69097-926_ce979024-ce98-455a-b11a-6a9d45bee0b8 69097-926 HUMAN PRESCRIPTION DRUG Amantadine hydrochloride Amantadine hydrochloride CAPSULE ORAL 20160930 ANDA ANDA207570 Cipla USA Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 69097-943_0aab3e2c-7053-4e36-95be-dcd3d0dd1271 69097-943 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20171205 ANDA ANDA090705 Cipla USA Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69097-944_52bdd978-0e60-4f48-b72e-616ee0d53dc3 69097-944 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20171116 ANDA ANDA205519 Cipla USA Inc., ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69097-945_52bdd978-0e60-4f48-b72e-616ee0d53dc3 69097-945 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20171116 ANDA ANDA205519 Cipla USA Inc., ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69097-946_52bdd978-0e60-4f48-b72e-616ee0d53dc3 69097-946 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20171116 ANDA ANDA205519 Cipla USA Inc., ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69097-947_52bdd978-0e60-4f48-b72e-616ee0d53dc3 69097-947 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20171116 ANDA ANDA205519 Cipla USA Inc., ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69100-1001_3e2faada-17fe-47c5-8abf-f3bf18665a67 69100-1001 HUMAN OTC DRUG TMC-A Hair Tonic OATMEAL LIQUID TOPICAL 20140711 OTC MONOGRAPH FINAL part347 Gahwa Well Food Co.,Ltd OATMEAL .0001 g/100mL E 20171231 69100-2001_83d30a96-9213-41d1-8131-05be7db54db5 69100-2001 HUMAN OTC DRUG TMC-A Anti Hairloss GLYCERIN SHAMPOO TOPICAL 20140711 OTC MONOGRAPH FINAL part347 Gahwa Well Food Co.,Ltd GLYCERIN 2 g/100g E 20171231 69100-3001_c11033d5-2991-47ae-91df-5b31b24f614f 69100-3001 HUMAN OTC DRUG TMCA HAIR COLOR Number Six (Natural dark brown) P-PHENYLENEDIAMINE LIQUID TOPICAL 20150903 UNAPPROVED DRUG OTHER Gahwa Well Food Co.,Ltd P-PHENYLENEDIAMINE 1.6 g/100g E 20171231 69101-400_544a27c6-727a-1717-e054-00144ff88e88 69101-400 HUMAN PRESCRIPTION DRUG Fenoprofen Calcium fenoprofen calcium CAPSULE ORAL 20170703 NDA NDA017604 Burke Therapeutics, LLC FENOPROFEN CALCIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69101-700_480b59ee-1937-049d-e054-00144ff88e88 69101-700 HUMAN OTC DRUG SulfaCLEAR SulfaClear cleansing bar soap SOAP TOPICAL 20170126 OTC MONOGRAPH FINAL part333D Burke Therapeutics, LLC SULFUR .33 g/1 N 20181231 69101-715_1d0cdc40-018f-5683-e054-00144ff88e88 69101-715 HUMAN PRESCRIPTION DRUG CLIN-Single Use Kit Clindamycin KIT INTRAMUSCULAR; INTRAVENOUS 20150811 ANDA ANDA062800 Burke Therapeutics, LLC E 20171231 69102-101_4bdc3df6-2e89-47e0-9d91-f3865f8190e3 69102-101 HUMAN PRESCRIPTION DRUG ROWEEPRA levetiracetam TABLET, FILM COATED ORAL 20160427 ANDA ANDA090906 OWP Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 69102-102_e8c79c4a-d4e1-0a76-467f-e5c6283750b1 69102-102 HUMAN PRESCRIPTION DRUG ROWEEPRA levetiracetam TABLET, FILM COATED ORAL 20170330 ANDA ANDA090906 OWP Pharmaceuticals, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 69102-103_e8c79c4a-d4e1-0a76-467f-e5c6283750b1 69102-103 HUMAN PRESCRIPTION DRUG ROWEEPRA levetiracetam TABLET, FILM COATED ORAL 20170330 ANDA ANDA090906 OWP Pharmaceuticals, Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 69102-104_e8c79c4a-d4e1-0a76-467f-e5c6283750b1 69102-104 HUMAN PRESCRIPTION DRUG ROWEEPRA levetiracetam TABLET, FILM COATED ORAL 20170330 ANDA ANDA090906 OWP Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 69102-137_c52da9ba-77eb-4b27-ae55-810681276024 69102-137 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Kit LAMOTRIGINE KIT 20170830 ANDA ANDA078947 OWP Pharmaceuticals, Inc. N 20181231 69102-200_601eaa2b-5c17-74c6-e053-2991aa0a1123 69102-200 HUMAN PRESCRIPTION DRUG ROWEEPRA XR levetiracetam TABLET, EXTENDED RELEASE ORAL 20171222 ANDA ANDA202095 OWP Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69102-201_601eaa2b-5c17-74c6-e053-2991aa0a1123 69102-201 HUMAN PRESCRIPTION DRUG ROWEEPRA XR levetiracetam TABLET, EXTENDED RELEASE ORAL 20171222 ANDA ANDA202095 OWP Pharmaceuticals, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69102-359_c52da9ba-77eb-4b27-ae55-810681276024 69102-359 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Kit LAMOTRIGINE KIT 20170830 ANDA ANDA078947 OWP Pharmaceuticals, Inc. N 20181231 69102-639_c52da9ba-77eb-4b27-ae55-810681276024 69102-639 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20170830 ANDA ANDA078947 OWP Pharmaceuticals, Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 69103-2180_f4af907f-9ce8-4bb1-961a-61bb157adcf9 69103-2180 HUMAN OTC DRUG Eye Wash Purified Water LIQUID OPHTHALMIC 20150723 OTC MONOGRAPH FINAL part349 Provision Medical Products WATER 983 mg/mL N 20181231 69103-2400_294cef14-6b97-4221-9f9e-13e9529194ff 69103-2400 HUMAN OTC DRUG Biotic-Plus bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine OINTMENT TOPICAL 20140724 OTC MONOGRAPH FINAL part333B Provision Medical BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; LIDOCAINE 400; 3.5; 5000; .4 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 69103-2501_33505e4e-b489-4998-9630-4246f4af307d 69103-2501 HUMAN OTC DRUG Aspirin 5 grain Aspirin TABLET ORAL 20150331 OTC MONOGRAPH NOT FINAL part343 Provision Medical Products ASPIRIN 325 mg/1 N 20181231 69103-2507_2e873528-b9a9-45c6-b995-ffdf527a3494 69103-2507 HUMAN OTC DRUG PAIN TERMINATOR ASPIRIN, ACETAMINOPHEN, CAFFEINE, SALICYLAMIDE TABLET ORAL 20150331 OTC MONOGRAPH NOT FINAL part343 Provision Medical Products ASPIRIN; SALICYLAMIDE; ACETAMINOPHEN 162; 152; 110 mg/1; mg/1; mg/1 N 20181231 69103-2516_318060d0-2e20-4a54-ae29-72d6737439f3 69103-2516 HUMAN OTC DRUG RAZZMATAZZ ANTACID CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20150331 OTC MONOGRAPH FINAL part331 Provision Medical Products CALCIUM CARBONATE 420 mg/1 N 20181231 69103-2522_79801456-6e5c-4b5e-9a5c-020b67fc6e8c 69103-2522 HUMAN OTC DRUG Max Non Aspirin Acetaminophen TABLET ORAL 20150331 OTC MONOGRAPH NOT FINAL part343 Provision Medical Products ACETAMINOPHEN 500 mg/1 N 20181231 69103-2525_1cb44e65-c708-4ac1-a7e8-b59077f9d6a0 69103-2525 HUMAN OTC DRUG Flex-Prin Ibuprofen TABLET ORAL 20150331 ANDA ANDA079129 Provision Medical Products IBUPROFEN 200 mg/1 N 20181231 69103-2533_ece58542-7009-405a-adeb-e8889525f331 69103-2533 HUMAN OTC DRUG PAIN TERMINATOR 2 SEVERE ASPIRIN, ACETAMINOPHEN, CAFFEINE TABLET ORAL 20150403 OTC MONOGRAPH NOT FINAL part343 Provision Medical Products ASPIRIN; ACETAMINOPHEN 250; 250 mg/1; mg/1 N 20181231 69103-2536_0388c796-9872-4a46-a27f-ed2b4e374cf3 69103-2536 HUMAN OTC DRUG Sinu-Phen Phenylephrine HCl TABLET ORAL 20150331 OTC MONOGRAPH FINAL part341 Provision Medical Products PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 N 20181231 69103-2546_d6c59dc5-5d74-40b6-836c-747ab36a80e9 69103-2546 HUMAN OTC DRUG Sinu-Phen Plus Phenylephrine HCl, Acetaminophen TABLET ORAL 20150331 OTC MONOGRAPH FINAL part341 Provision Medical Products PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN 5; 500 mg/1; mg/1 N 20181231 69103-2550_1a930ddb-c405-471f-8c1b-c836e7a3d2f3 69103-2550 HUMAN OTC DRUG VICA-CET ACETAMINOPHEN, CAFFEINE,MAGNESIUM SALICYLATE TABLET ORAL 20150403 OTC MONOGRAPH NOT FINAL part343 Provision Medical Products MAGNESIUM SALICYLATE; ACETAMINOPHEN 250; 250 mg/1; mg/1 N 20181231 69103-2552_d4500828-f124-4613-83a4-d9fe1e17a504 69103-2552 HUMAN OTC DRUG POLARIS MINT ANTACID CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20150331 OTC MONOGRAPH FINAL part331 Provision Medical Products CALCIUM CARBONATE 420 mg/1 N 20181231 69103-2556_060fb937-8137-4657-bc75-fc0c7e126b26 69103-2556 HUMAN OTC DRUG Cold Terminator Max Phenylephrine HCl, ACETAMINOPHEN, GUAIFENESIN TABLET ORAL 20150331 OTC MONOGRAPH FINAL part341 Provision Medical Products PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN 5; 325; 200 mg/1; mg/1; mg/1 N 20181231 69103-3500_ee784266-bfe1-4518-b47e-7224dc58b834 69103-3500 HUMAN OTC DRUG Burn with Aloe Lidocaine Hydrochloride SPRAY TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part348 Provision Medical LIDOCAINE HYDROCHLORIDE 200 g/L N 20181231 69103-3501_ed3cb7fd-75d1-4b20-ad45-39fd5763a751 69103-3501 HUMAN OTC DRUG First Aid Antiseptic benzalkonium chloride and benzocaine SPRAY TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part333A Provision Medical BENZALKONIUM CHLORIDE; BENZOCAINE 1; 50 g/L; g/L N 20181231 69103-3502_fc8fa480-192d-4854-9a8e-7819f561dbec 69103-3502 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part333A Provision Medical ISOPROPYL ALCOHOL 700 mL/L N 20181231 69103-3503_86bb7692-df50-43dc-8f6f-0d71d6139fd9 69103-3503 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SPRAY TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part333A Provision Medical HYDROGEN PEROXIDE 30 mL/L N 20181231 69103-3553_82d0a229-1c96-43b2-9f8c-44af83fae748 69103-3553 HUMAN OTC DRUG First Aid benzalkonium chloride and lidocaine CREAM TOPICAL 20141202 OTC MONOGRAPH NOT FINAL part333A Provision Medical BENZALKONIUM CHLORIDE; LIDOCAINE 1.3; 5 mg/g; mg/g N 20181231 69103-3554_3f90b1ee-59b1-4a54-ad13-2485998570ba 69103-3554 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20150316 OTC MONOGRAPH NOT FINAL part333E Provision Medical ALCOHOL 665 mL/g N 20181231 69103-4506_c3e806f3-d361-4506-b56d-6c6bea81e3ed 69103-4506 HUMAN OTC DRUG Itch and Rash Cream Hydrocortisone CREAM TOPICAL 20150331 OTC MONOGRAPH NOT FINAL part348 Provision Medical Products HYDROCORTISONE 10 mg/g N 20181231 69103-5005_2a1ca9f4-e0b9-4540-bb99-091ad0404e17 69103-5005 HUMAN OTC DRUG Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate OINTMENT TOPICAL 20140829 OTC MONOGRAPH FINAL part333B Provision Medical BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 69106-010_bc78e6e2-db9a-4a2b-8da0-e996931721aa 69106-010 HUMAN OTC DRUG IT RADIANT CC IN MELTING FOUNDATION BE10 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE 1.68; .71 g/13g; g/13g N 20181231 69106-020_7cee0024-ea4d-4793-b789-e4331f8f664b 69106-020 HUMAN OTC DRUG IT RADIANT CC IN MELTING FOUNDATION BE15 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE 1.68; .71 g/13g; g/13g N 20181231 69106-030_84cab501-bf11-42c5-8766-d73c0e48c079 69106-030 HUMAN OTC DRUG IT RADIANT CC IN MELTING FOUNDATION BE20 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE 1.68; .71 g/13g; g/13g N 20181231 69106-040_4010e579-1c03-48ca-994d-f9318b8c33b7 69106-040 HUMAN OTC DRUG IT RADIANT CC CUSHION BE10 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.07; 1.05; .45 g/15g; g/15g; g/15g N 20181231 69106-050_f14cbfae-e07e-4271-a30e-0b32a2e2b768 69106-050 HUMAN OTC DRUG IT RADIANT CC CUSHION BP15 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.07; 1.05; .45 g/15g; g/15g; g/15g N 20181231 69106-060_22037846-fd28-448b-93f2-ab4deeb4ffe5 69106-060 HUMAN OTC DRUG IT RADIANT CC CUSHION BE20 TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.07; 1.05; .45 g/15g; g/15g; g/15g N 20181231 69106-070_b39ff79b-270b-44ab-b936-51d3c3ce131c 69106-070 HUMAN OTC DRUG IT RADIANT GLOW BB TRUE BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.9; 1.5; .88 mg/30mL; mg/30mL; mg/30mL N 20181231 69106-080_46fa36af-230b-4d91-82fa-228a59d56429 69106-080 HUMAN OTC DRUG IT RADIANT GLOW BB CLASSIC BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.9; 1.5; .88 mg/30mL; mg/30mL; mg/30mL N 20181231 69106-090_eb17f988-7d9e-4079-bbeb-4d19dfbf545e 69106-090 HUMAN OTC DRUG IT RADIANT MULTIPLE CC FOR MAN OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 2.1; 2.09; .9 mg/30mL; mg/30mL; mg/30mL N 20181231 69106-100_e6b8202e-fa0a-4ac4-b392-7e6b09a41e7c 69106-100 HUMAN OTC DRUG IT RADIANT CC OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 2.01; 1.27; .75 mg/30mL; mg/30mL; mg/30mL N 20181231 69106-110_6f4b362a-ac93-4660-bb55-97d75b495dc8 69106-110 HUMAN OTC DRUG IT RADIANT BRIGHTENING Dimethicone CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE 1 mg/50mL N 20181231 69106-120_ade417ab-dcda-4ace-901d-0488699c29ff 69106-120 HUMAN OTC DRUG CLEAN IT ZERO RADIANCE Mineral Oil CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. MINERAL OIL 63.2 mg/100mL N 20181231 69106-130_b305007d-38f2-40c5-ab51-b09c917be4b3 69106-130 HUMAN OTC DRUG PRIME PRIMER FINISH Dimethicone POWDER TOPICAL 20140701 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE 2.16 g/12g N 20181231 69106-140_492e03c3-5c44-461c-b920-38f686c64d52 69106-140 HUMAN OTC DRUG PRIME PRIMER HYDRATING FINISH Dimethicone POWDER TOPICAL 20140701 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE 1.85 g/12g N 20181231 69106-150_84efea03-9cfb-4795-9ca5-4280d9491130 69106-150 HUMAN OTC DRUG PRIME PRIMER HYDRATING BALM Titanium Dioxide CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE .02 g/20g N 20181231 69106-160_ae7953b0-2cdd-4ebc-a296-d6f02de4abbd 69106-160 HUMAN OTC DRUG PRIME PRIMER CLASSIC Dimethicone CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE 1.5 mg/30mL N 20181231 69106-170_ff72b1d3-31f8-4664-a490-8190cf0ba08b 69106-170 HUMAN OTC DRUG PRIME PRIMER HYDRATING Dimethicone CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE .9 mg/30mL N 20181231 69106-180_c5529b40-6053-4e66-bb11-426358163845 69106-180 HUMAN OTC DRUG PRIME PRIMER BB SHEER Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.9; 1.5; .88 mg/30mL; mg/30mL; mg/30mL N 20181231 69106-190_e2cfd4e5-8a0f-41e5-bdfb-fa7acb2bec09 69106-190 HUMAN OTC DRUG PRIME PRIMER BB NUDE Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20140701 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.9; 1.5; .88 mg/30mL; mg/30mL; mg/30mL N 20181231 69106-200_c6553cbf-bc08-44dc-9e7e-1894eb41da63 69106-200 HUMAN OTC DRUG V V BOUNCING CUSHION BE10 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.54; 1; .6 g/21; g/21; g/21 N 20181231 69106-210_8851e1e6-ae36-4aaf-9dee-47b38d0394b3 69106-210 HUMAN OTC DRUG V V BOUNCING CUSHION BE20 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.54; 1; .6 g/21; g/21; g/21 N 20181231 69106-220_613e9eb4-c322-4f9d-be3c-5b01a24c8911 69106-220 HUMAN OTC DRUG V V BOUNCING CUSHION BP15 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.54; 1; .6 g/21; g/21; g/21 N 20181231 69106-230_346ca150-eb8d-483f-8acf-2be78c146ee2 69106-230 HUMAN OTC DRUG Blooming Shield to foam cleanser Glycerin LIQUID TOPICAL 20150301 UNAPPROVED DRUG OTHER F&CO Co., Ltd. GLYCERIN 6 mg/150mL N 20181231 69106-240_9f85aec1-cf6a-4b83-ad60-6d3be933f04d 69106-240 HUMAN OTC DRUG Blooming Shield Blossom Mist Butylene Glycol SPRAY TOPICAL 20150301 UNAPPROVED DRUG OTHER F&CO Co., Ltd. BUTYLENE GLYCOL 1.92 mg/80mL N 20181231 69106-250_ab502a49-4c32-4fe5-9318-080cc53242b4 69106-250 HUMAN OTC DRUG Blooming Shield Waterful Glycerin CREAM TOPICAL 20150301 UNAPPROVED DRUG OTHER F&CO Co., Ltd. GLYCERIN 2.7 mg/90mL N 20181231 69106-260_030241c7-1625-40dd-bfcf-abd848db8ffb 69106-260 HUMAN OTC DRUG it Radiant Brightening Essence Dimethicone CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE .96 mg/30mL N 20181231 69106-270_9c28e4f9-b61d-492e-b272-ad5bf4e32271 69106-270 HUMAN OTC DRUG it Radiant Brightening Eye Dimethicone CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE .2 mg/20mL N 20181231 69106-280_be761a3b-f7db-4810-aa52-5b38a14150bf 69106-280 HUMAN OTC DRUG it Radiant Brightening Dimethicone LOTION TOPICAL 20150301 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE 2 mg/200mL N 20181231 69106-290_fcd5a255-68ab-4dca-bd26-ac5a143458b5 69106-290 HUMAN OTC DRUG it Radiant Brightening Sleeping Pack Dimethicone CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 F&CO Co., Ltd. DIMETHICONE .95 mg/30mL N 20181231 69106-300_7efb8672-f2ee-414c-9436-9d5255d9c959 69106-300 HUMAN OTC DRUG it Radiant Brightening Toner Niacinamide LIQUID TOPICAL 20150301 UNAPPROVED DRUG OTHER F&CO Co., Ltd. NIACINAMIDE 4 mg/200mL N 20181231 69106-310_061f1fbb-07da-444b-b7f8-6fe70e064730 69106-310 HUMAN OTC DRUG it Radiant CC Sun Base Titanium Dioxide, Octinoxate, Octisalate CREAM TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 2.66; 2.01; 1.2 mg/30mL; mg/30mL; mg/30mL N 20181231 69106-320_8bc9c28a-3e05-49f4-84d5-1bcddc518480 69106-320 HUMAN OTC DRUG BIRDS NEST FOREVER YOUNG MULTI CARE LIFTING Niacinamide, Adenosine CREAM TOPICAL 20150301 UNAPPROVED DRUG OTHER F&CO Co., Ltd. NIACINAMIDE; ADENOSINE 1.2; .02 mg/60mL; mg/60mL N 20181231 69106-330_7bb18035-2a87-410f-a86e-8476b5fad528 69106-330 HUMAN OTC DRUG V V Vitalizing Serum Niacinamide CREAM TOPICAL 20150301 UNAPPROVED DRUG OTHER F&CO Co., Ltd. NIACINAMIDE .9 mg/45mL N 20181231 69106-340_baa6f369-eb89-4c8c-a8a2-70d777aab04c 69106-340 HUMAN OTC DRUG V V Vitalizing Eye Niacinamide CREAM TOPICAL 20150301 UNAPPROVED DRUG OTHER F&CO Co., Ltd. NIACINAMIDE .4 mg/20mL N 20181231 69106-350_f6f083c3-7e3b-4004-a779-0f92944dc890 69106-350 HUMAN OTC DRUG Cover 10 Perfect BB Light Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.71; 2.1; 1.17 mg/30mL; mg/30mL; mg/30mL N 20181231 69106-360_ca55e828-cb3b-487e-b1da-40eed32a65b5 69106-360 HUMAN OTC DRUG Cover 10 Perfect BB Natural Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.71; 2.1; 1.17 mg/30mL; mg/30mL; mg/30mL N 20181231 69106-370_5acc1662-c001-408c-86f5-4c57e286291e 69106-370 HUMAN OTC DRUG Cover 10 Perfect Foundation BE10 Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.98; 1.2; .29 mg/30mL; mg/30mL; mg/30mL N 20181231 69106-380_42e714be-49bc-4743-beac-2fda78194a58 69106-380 HUMAN OTC DRUG Cover 10 Perfect Foundation BE20 Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.98; 1.2; .29 mg/30mL; mg/30mL; mg/30mL N 20181231 69106-390_65aebd34-a2c9-46c6-931d-5418c6dfaca9 69106-390 HUMAN OTC DRUG Cover 10 Perfect Foundation BP15 Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 3.98; 1.2; .29 mg/30mL; mg/30mL; mg/30mL N 20181231 69106-400_98c18003-7b08-4ead-b3ba-f3d89249c9ca 69106-400 HUMAN OTC DRUG BANILA CO It Radiant CC Tone up Niacinamide, Adenosine CREAM TOPICAL 20171001 UNAPPROVED DRUG OTHER F&CO Co., Ltd. NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 69106-410_daeb328f-4e30-49cd-9d80-7c6a85d5b8d2 69106-410 HUMAN OTC DRUG BANILA CO Prime Primer Fitting BB Light Beige Titanium Dioxide, Zinc Oxide, Octinoxate CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 2.9; .88; 1.5 g/30mL; g/30mL; g/30mL N 20181231 69106-420_238a1608-40cf-46cd-b708-88b27da77252 69106-420 HUMAN OTC DRUG BANILA CO Prime Primer Fitting BB Natural Beige Titanium Dioxide, Zinc Oxide, Octinoxate CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 2.9; .88; 1.5 g/30mL; g/30mL; g/30mL N 20181231 69106-430_ef3cafa2-5e11-402f-9b58-0bb80e2cf672 69106-430 HUMAN OTC DRUG BANILA CO Prime Primer Sun Avobenzone, Octinoxate, Octocrylene, Octisalate, Homosalate, Ensulizole CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OCTISALATE; HOMOSALATE; ENSULIZOLE 1.05; 2.07; .6; 1.35; .9; 1.05 g/30mL; g/30mL; g/30mL; g/30mL; g/30mL; g/30mL N 20181231 69106-440_0e9474e5-e72d-4eba-9066-535be5f8a623 69106-440 HUMAN OTC DRUG It Radiant CC Color Base Lavender Titanium Dioxide, Zinc Oxide, Octinoxate CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 1.32; 1.47; 1.5 g/30mL; g/30mL; g/30mL N 20181231 69106-450_23a46460-3f00-44f7-99ce-e8401c242eea 69106-450 HUMAN OTC DRUG It Radiant CC Color Base Mint Titanium Dioxide, Zinc Oxide, Octinoxate CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 1.23; 1.47; 1.5 g/30mL; g/30mL; g/30mL N 20181231 69106-460_c0e39a50-df59-4d9f-948a-e337a14e8018 69106-460 HUMAN OTC DRUG It Radiant CC Color Base Rose Titanium Dioxide, Zinc Oxide, Octinoxate CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 1.28; 1.47; 1.5 g/30mL; g/30mL; g/30mL N 20181231 69106-470_cc270b3d-b51a-43cd-8983-c7513e719f75 69106-470 HUMAN OTC DRUG It Radiant CC Cover Light Beige Titanium Dioxide, Zinc Oxide, Octinoxate CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 2.32; 1.47; 1.5 g/30mL; g/30mL; g/30mL N 20181231 69106-480_991c563a-b05d-4118-a663-4c1ace863729 69106-480 HUMAN OTC DRUG It Radiant CC Cover Natural Beige Titanium Dioxide, Zinc Oxide, Octinoxate CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 F&CO Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 2.2; 1.47; 1.5 g/30mL; g/30mL; g/30mL N 20181231 69108-001_26bc01dd-3752-48a4-bb65-a04867b0d414 69108-001 HUMAN OTC DRUG smilecare SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20140601 OTC MONOGRAPH FINAL part355 Shantou MContinents Trading Co, LTD SODIUM MONOFLUOROPHOSPHATE 64 mg/8g N 20181231 69109-004_fc59ad0a-e1a6-40e9-a273-07086413c616 69109-004 HUMAN OTC DRUG Simplicity Desensitizing Lidocaine GEL TOPICAL 20140715 OTC MONOGRAPH NOT FINAL part348 Simplicity Laser, LLC LIDOCAINE 40 mg/mL E 20171231 69114-1001_1751bc34-4dd1-4169-a3d5-2cc522213838 69114-1001 HUMAN OTC DRUG Narasoo Healing SALICYLIC ACID SHAMPOO TOPICAL 20140716 OTC MONOGRAPH FINAL part358H RAKU STORY Co., Ltd SALICYLIC ACID .06 g/mL E 20171231 69114-2001_bbdc50eb-77ac-4b8b-b0ac-a046f4487890 69114-2001 HUMAN OTC DRUG Narasoo Hair Tonic SALICYLIC ACID LIQUID TOPICAL 20140716 OTC MONOGRAPH FINAL part358H RAKU STORY Co., Ltd SALICYLIC ACID .06 g/mL E 20171231 69117-0001_614b0839-9b4a-5e27-e053-2a91aa0acae3 69117-0001 HUMAN OTC DRUG Acetaminophen Regular Strength Acetaminophen TABLET ORAL 20160315 20181130 OTC MONOGRAPH NOT FINAL part343 YILING PHARMACEUTICAL,INC. ACETAMINOPHEN 324.9 mg/361mg N 20181231 69117-0002_614a9472-f99f-499c-e053-2a91aa0a1122 69117-0002 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20160315 20181130 OTC MONOGRAPH NOT FINAL part343 YILING PHARMACEUTICAL,INC. ACETAMINOPHEN 500.4 mg/556mg N 20181231 69117-1000_5fb5d58b-895a-412b-e053-2991aa0a5dd2 69117-1000 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20170329 ANDA ANDA203646 YILING PHARMACEUTICAL, INC. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 69117-1010_59ae836d-3d6e-62f0-e053-2a91aa0a8fb9 69117-1010 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20170505 ANDA ANDA204165 YILING PHARMACEUTICAL,INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 69119-001_fc134c19-d4aa-46cb-ac13-07a1e192bb08 69119-001 HUMAN OTC DRUG BANDAGE benzalkonium chloride SWAB TOPICAL 20140716 OTC MONOGRAPH NOT FINAL part333A Dongyang Haodi Medical CO.,Ltd BENZALKONIUM CHLORIDE .0012 mg/mg E 20171231 69121-001_c2439eb0-35a1-4954-af4b-d0bdac16c768 69121-001 HUMAN OTC DRUG TopicSkin HYDRASTIS CANADENSIS WHOLE, MENTHA PIPERITA, MELISSA OFFICINALIS CREAM TOPICAL 20141110 UNAPPROVED HOMEOPATHIC ZBM Natural Medicine Ltd. HYDRASTIS CANADENSIS WHOLE; MENTHA PIPERITA; MELISSA OFFICINALIS 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69123-111_7d1c93bb-808e-4e8d-9670-af940f07a4bc 69123-111 HUMAN OTC DRUG Skin Protectant Colloidal Oatmeal OINTMENT TOPICAL 20140725 OTC MONOGRAPH FINAL part347 ELAJ, LLC OATMEAL .57 g/57g E 20171231 69125-001_3b4535d4-b08e-4498-8805-9f8e7b508915 69125-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140718 UNAPPROVED MEDICAL GAS SMP Home Medical OXYGEN 99 L/100L E 20171231 69126-001_5d8e94f9-8c33-e3cb-e053-2a91aa0a84e1 69126-001 HUMAN PRESCRIPTION DRUG Ammonia N 13 Ammonia N 13 INJECTION INTRAVENOUS 20141031 ANDA ANDA204465 Global Isotopes, LLC d/b/a Zevacor Molecular AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 69126-002_5d8f7089-c735-9a24-e053-2a91aa0a83df 69126-002 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 Sodium Fluoride F 18 INJECTION INTRAVENOUS 20141031 ANDA ANDA204464 Global Isotopes, LLC d/b/a Zevacor Molecular FLUORIDE ION F-18 10 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 69126-003_5d8fc726-7dfd-0f21-e053-2a91aa0acef7 69126-003 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20141031 ANDA ANDA204463 Global Isotopes, LLC d/b/a Zevacor Molecular FLUDEOXYGLUCOSE F-18 20 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 69126-004_5d7fc9e5-163d-edc8-e053-2a91aa0a934e 69126-004 HUMAN PRESCRIPTION DRUG Choline C 11 Choline C11 INJECTION INTRAVENOUS 20151231 ANDA ANDA206319 Global Isotopes, LLC d/b/a Zevacor Molecular CHOLINE C-11 4 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 69128-001_fbb1eee7-5268-43f7-9cf3-2a26af58be56 69128-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140721 UNAPPROVED MEDICAL GAS Imedequip dba Independent Medical Equipment OXYGEN 99 L/100L E 20171231 69129-010_23e9fa8e-7332-47dd-9129-93298029a6e7 69129-010 HUMAN OTC DRUG Hydro Kleen AF Benzalkonium Chloride LIQUID TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part333E Productive Practices BENZALKONIUM CHLORIDE .13 g/mL E 20171231 69133-010_b7733180-bd35-40f2-9572-af592e7277fb 69133-010 HUMAN OTC DRUG BIOXIDEA MIRACLE 48 EXCELLENCE DIAMOND MASK Allantoin GEL TOPICAL 20140701 OTC MONOGRAPH FINAL part347 Cosmetics Institute Technology Co., Ltd. ALLANTOIN .15 g/31 E 20171231 69133-020_8ff80105-46ff-49d9-85fe-8a3a9cdf0c2c 69133-020 HUMAN OTC DRUG BIOXIDEA MIRACLE 48 EXCELLENCE GOLD MASK Allantoin GEL TOPICAL 20140701 OTC MONOGRAPH FINAL part347 Cosmetics Institute Technology Co., Ltd. ALLANTOIN .15 g/31 E 20171231 69133-030_a629289f-6bfb-4012-aaeb-cc0af33d17d4 69133-030 HUMAN OTC DRUG BIOXIDEA ELEMENT 48 NATURA DIAMOND MASK Allantoin PATCH TOPICAL 20140701 OTC MONOGRAPH FINAL part347 Cosmetics Institute Technology Co., Ltd. ALLANTOIN .15 g/31 E 20171231 69133-040_03897604-650a-49d6-89ab-6810deb7503a 69133-040 HUMAN OTC DRUG BIOXIDEA ELEMENT 48 NATURA GOLD MASK Allantoin PATCH TOPICAL 20140701 OTC MONOGRAPH FINAL part347 Cosmetics Institute Technology Co., Ltd. ALLANTOIN .15 g/31 E 20171231 69134-0001_a8afd835-93ef-4a93-a361-46d4ad790ac7 69134-0001 HUMAN OTC DRUG Lymph Drainage not applicable LIQUID ORAL 20140828 UNAPPROVED HOMEOPATHIC Carnivora Research International ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; BAPTISIA TINCTORIA; LEMON JUICE; LOBELIA INFLATA; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; TEUCRIUM SCORODONIA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; CAPSICUM; COPPER GLUCONATE; POTASSIUM CHLORIDE; MANGANESE GLUCONATE; ARANEUS DIADEMATUS; ARSENIC TRIIODIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; CENTAURIUM ERYTHRAEA FLOWER; CARPINUS BETULUS FLOWERING TOP; LACHESIS MUTA VENOM; LARIX DECIDUA FLOWERING TOP; SUS SCROFA LYMPH; SUS SCROFA THYMUS; ZINC GLUCONATE; SUS SCROFA SPLEEN 2; 2; 3; 3; 3; 3; 3; 3; 4; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69138-783_ed539e7d-d566-44e3-b20d-879767a8f002 69138-783 HUMAN OTC DRUG Sani Claw Wipes ALCOHOL CLOTH TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part333E Homeland Industrial Supply ALCOHOL 620 mg/g N 20181231 69139-001_871fa8e9-533a-471c-8f83-6d2446e56a07 69139-001 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20140724 OTC MONOGRAPH NOT FINAL part333A YIWU HAODING MEDICAL CO.,LTD ALCOHOL 70 mL/100mL E 20171231 69139-106_ef032cdf-c460-413b-9846-dd381ee9849a 69139-106 HUMAN OTC DRUG coralite ANTIBACTERIAL BANDAGES benzalkonium chloride SWAB TOPICAL 20180114 OTC MONOGRAPH NOT FINAL part333A YIWU HAODING MEDICAL CO.,LTD BENZALKONIUM CHLORIDE .12 g/100g N 20191231 69140-620_1cba7bae-bc4c-2fc5-e054-00144ff88e88 69140-620 HUMAN OTC DRUG Klernaz Guaifenesin, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide TABLET ORAL 20150807 OTC MONOGRAPH FINAL part341 Pharma Associate Consultants, Inc DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 15; 400; 10 mg/1; mg/1; mg/1 E 20171231 69142-001_abb19068-91b0-4f21-b3d2-b3c138507876 69142-001 HUMAN OTC DRUG Breast Essence II Dimethicone, Allantoin CREAM TOPICAL 20140729 OTC MONOGRAPH FINAL part347 yeojaya DIMETHICONE; ALLANTOIN .5; 1 mg/50mL; mg/50mL E 20171231 69144-001_20cbc09f-246e-427f-898f-98efeda04619 69144-001 HUMAN OTC DRUG Advanced Formula Lip Moisturizer Sunscreen SPF 25 AVOBENZONE,OCTINOXATE CREAM TOPICAL 20150908 OTC MONOGRAPH NOT FINAL part352 Anthony Brands LLC AVOBENZONE; OCTINOXATE .03; .075 g/g; g/g E 20171231 69145-201_47f4dfd4-b80b-4c18-e054-00144ff88e88 69145-201 HUMAN OTC DRUG Desert Harvest RELEVEUM LIDOCAINE CREAM TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part348 Desert Harvest Inc. LIDOCAINE 40 mg/mL N 20181231 69146-301_f88b525b-6fad-40dd-b021-2dff987b2516 69146-301 HUMAN OTC DRUG BROAD SPECTRUM SUNSCREEN SPF 30 TITANIUM DIOXIDE CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part352 TRUTH AESTHETICS LLC TITANIUM DIOXIDE 12.1 mg/100mL E 20171231 69147-196_47f4d4c4-fb62-5e0e-e054-00144ff8d46c 69147-196 HUMAN OTC DRUG FRENCH SECRET SPF - 15 Day Broad-Spectrum TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 Manupro, Inc. TITANIUM DIOXIDE; ZINC OXIDE 35; 35 mg/mL; mg/mL N 20181231 69148-001_e8a569be-9814-403b-a969-67217d6c5e81 69148-001 HUMAN OTC DRUG ARC Skin Protectant ALLANTOIN OINTMENT TOPICAL 20140806 OTC MONOGRAPH FINAL part347 Anjon Biologics, Inc ALLANTOIN .5 g/100g N 20181231 69149-100_79d7196c-41c5-4bb0-be8d-c3c0cebd1e35 69149-100 HUMAN OTC DRUG PHS Hair Science Pro Hair Loss Tonic Salicylic Acid, Niacinamide, Menthol LIQUID TOPICAL 20140825 UNAPPROVED DRUG OTHER Revamp International Pte. Ltd. SALICYLIC ACID; NIACINAMIDE; MENTHOL .3; .3; .3 1/100mL; 1/100mL; 1/100mL E 20171231 69149-101_a18d381b-314c-436f-8398-d9866e5c82b2 69149-101 HUMAN OTC DRUG PHS Hair Science Fem Hair Loss Tonic Salicylic Acid, Niacinamide, Menthol LIQUID TOPICAL 20140826 UNAPPROVED DRUG OTHER Revamp International Pte. Ltd. SALICYLIC ACID; NIACINAMIDE; MENTHOL .3; .3; .3 1/100mL; 1/100mL; 1/100mL E 20171231 69149-102_8a2afc0e-2be6-476d-a0c6-5e394e5f3d9f 69149-102 HUMAN OTC DRUG PHS Hair Science Hom Hair Loss Tonic Salicylic Acid, Niacinamide, Menthol LIQUID TOPICAL 20140917 UNAPPROVED DRUG OTHER Revamp International Pte. Ltd. SALICYLIC ACID; NIACINAMIDE; MENTHOL .3; .3; .3 1/100mL; 1/100mL; 1/100mL E 20171231 69149-103_2a417d0b-10a9-4614-bf0c-c8192155351d 69149-103 HUMAN OTC DRUG PHS Hair Science Adv Revitalizing Scalp Ampoule Eucalyptus Oil, Allantoin LIQUID TOPICAL 20140917 UNAPPROVED DRUG OTHER Revamp International Pte. Ltd. EUCALYPTUS OIL; ALLANTOIN .05; .1 1/10mL; 1/10mL E 20171231 69150-020_535b1232-f479-4ed2-bb13-f7d049c5a638 69150-020 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20160225 ANDA ANDA202075 BIOMES PHARMACEUTICALS LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 69150-138_b91b8834-9d71-4a53-ac54-762da3d5c578 69150-138 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20150323 ANDA ANDA091416 Biomes Pharmaceuticals NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69150-139_b91b8834-9d71-4a53-ac54-762da3d5c578 69150-139 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20150323 ANDA ANDA091416 Biomes Pharmaceuticals NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69150-140_b91b8834-9d71-4a53-ac54-762da3d5c578 69150-140 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20150323 ANDA ANDA091416 Biomes Pharmaceuticals NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69150-225_b0f8842c-fd1f-4aef-aab4-a9b7bf1e04f8 69150-225 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin CREAM TOPICAL 20160322 ANDA ANDA201587 BIOMES PHARMACEUTICALS LLC MUPIROCIN CALCIUM 2 g/100g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 69150-258_62d7ea83-76ae-4200-bb57-ff384c907536 69150-258 HUMAN PRESCRIPTION DRUG Trospium Chloride Trospium Chloride TABLET ORAL 20100813 ANDA ANDA091575 BIOMES PHARMACEUTICALS LLC TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 69150-273_9df8c0af-564a-4613-b9c9-c5ad40f4d7bb 69150-273 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20160322 ANDA ANDA090480 BIOMES PHARMACEUTICALS LLC MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 69150-400_bf68e5f3-a07d-4674-bc03-d4ba7bf42df4 69150-400 HUMAN PRESCRIPTION DRUG Ibuprofen IBUPROFEN TABLET, COATED ORAL 20090502 ANDA ANDA078329 Biomes Pharmaceuticals LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69150-600_5f358a9c-46a2-40b3-a09b-dec0f23111df 69150-600 HUMAN PRESCRIPTION DRUG Ibuprofen IBUPROFEN TABLET, COATED ORAL 20090502 ANDA ANDA078329 Biomes Pharmaceuticals LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69150-800_8a81f004-63e2-4cc7-b779-43a75bc26673 69150-800 HUMAN PRESCRIPTION DRUG Ibuprofen IBUPROFEN TABLET, COATED ORAL 20090502 ANDA ANDA078329 Biomes Pharmaceuticals LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69151-100_e1b2de5a-624b-4b38-806f-697bc1e3542f 69151-100 HUMAN OTC DRUG Aspi-Rub Pain Reliever Methyl Salicylate SPRAY TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part348 AspiRub Enterprises LLC METHYL SALICYLATE 23 g/100g E 20171231 69152-0001_488d9492-69bd-2936-e054-00144ff8d46c 69152-0001 HUMAN OTC DRUG Dilon 40 (Number 1) Cactus Grandiflorus, Carbo Vegetabilis PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ACTIVATED CHARCOAL; SELENICEREUS GRANDIFLORUS STEM 200; 30 [hp_C]/1; [hp_C]/1 N 20181231 69152-0003_40f0080b-a1b3-4582-e054-00144ff88e88 69152-0003 HUMAN OTC DRUG Inosal 40 Number 3 Bryonia alba, Pulsatilla nigricans PELLET ORAL 20150116 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; PULSATILLA PRATENSIS 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0004_448c0595-8cb6-606a-e054-00144ff88e88 69152-0004 HUMAN OTC DRUG Slipaik 40 Number 4 Argentum nitricum, Nux vomica PELLET ORAL 20150114 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SILVER NITRATE; STRYCHNOS NUX-VOMICA SEED 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0005_64738c6e-f827-f271-e053-2a91aa0a40b4 69152-0005 HUMAN OTC DRUG Nonak 40 (Number 5) Ipecacuanha, Bryonia Alba PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; IPECAC 30; 200 [hp_C]/1; [hp_C]/1 N 20191231 69152-0006_64731776-5886-4d88-e053-2a91aa0a0b13 69152-0006 HUMAN OTC DRUG Cals 40 (Number 6) Antimonium Crudum, Mezereum PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC DAPHNE MEZEREUM BARK; ANTIMONY TRISULFIDE 200; 6 [hp_C]/1; [hp_C]/1 N 20191231 69152-0007_64738c6e-f81a-f271-e053-2a91aa0a40b4 69152-0007 HUMAN OTC DRUG Kalop 40 (Number 7) Pulsatilla Nigricans, Nux Vomica PELLET ORAL 20141111 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC PULSATILLA PRATENSIS; STRYCHNOS NUX-VOMICA SEED 200; 200 [hp_C]/1; [hp_C]/1 N 20191231 69152-0008_40dc9e39-f069-16a4-e054-00144ff8d46c 69152-0008 HUMAN OTC DRUG Bejinj 40 (Number 8) Antimonium Crudum, Arnica Montana PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; ARNICA MONTANA 200; 3 [hp_C]/1; [hp_C]/1 E 20171231 69152-0009_488d9492-69e8-2936-e054-00144ff8d46c 69152-0009 HUMAN OTC DRUG Restil 40 Number 9 Aralia racemosa, Arsenicum album PELLET ORAL 20150113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARALIA RACEMOSA ROOT; ARSENIC TRIOXIDE 200; 6 [hp_C]/1; [hp_C]/1 N 20181231 69152-0010_547fc70a-f803-32d6-e054-00144ff8d46c 69152-0010 HUMAN OTC DRUG Panuls 40 (Number 10) Antimonium crudum, Arnica montana PELLET ORAL 20141120 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; ARNICA MONTANA 200; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0011_40f0e1e5-7916-4a44-e054-00144ff8d46c 69152-0011 HUMAN OTC DRUG Onemet 40 (Number 11) Argentum Metallicum, Caladium Seguinum PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SILVER; DIEFFENBACHIA SEGUINE 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0013_0e802d55-51a7-6417-e054-00144ff88e88 69152-0013 HUMAN OTC DRUG Bedin 40 (Number 13) Thuja Occidentalis, Belladonna PELLET ORAL 20141103 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC THUJA OCCIDENTALIS LEAFY TWIG; ATROPA BELLADONNA 200; 3 [hp_C]/1; [hp_C]/1 E 20171231 69152-0014_488a746d-7524-0b9d-e054-00144ff8d46c 69152-0014 HUMAN OTC DRUG Rugin 40 (Number 14) Argentum Metallicum, Stramonium PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SILVER; DATURA STRAMONIUM 200; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0016_40f0080b-a1bd-4582-e054-00144ff88e88 69152-0016 HUMAN OTC DRUG Mushru 40 Number 16 Antimonium crudum, Arsenicum album PELLET ORAL 20150302 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARSENIC TRIOXIDE; ANTIMONY TRISULFIDE 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0017_1023b43f-1b1b-0eae-e054-00144ff88e88 69152-0017 HUMAN OTC DRUG Bulb 40 (Number 17) Calcarea Carbonica, Ledum Palustre PELLET ORAL 20141104 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC OYSTER SHELL CALCIUM CARBONATE, CRUDE; LEDUM PALUSTRE TWIG 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0018_40dcacfb-6903-56f2-e054-00144ff88e88 69152-0018 HUMAN OTC DRUG Basaki 40 (Number 18) Conium Maculatum, Phytolacca PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CONIUM MACULATUM FLOWERING TOP; PHYTOLACCA AMERICANA ROOT 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0020_50438757-c9c7-71d9-e054-00144ff8d46c 69152-0020 HUMAN OTC DRUG Shica 40 Number 20 Allium cepa, Bryonia alba PELLET ORAL 20150113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ONION; BRYONIA ALBA ROOT 30; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0022_64731776-5876-4d88-e053-2a91aa0a0b13 69152-0022 HUMAN OTC DRUG Bauri 40 (Number 22) Lycopodium, Bryonia alba PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYCOPODIUM CLAVATUM SPORE; BRYONIA ALBA ROOT 30; 30 [hp_C]/1; [hp_C]/1 N 20191231 69152-0023_1023b43f-1b06-0eae-e054-00144ff88e88 69152-0023 HUMAN OTC DRUG Uribur 40 Number 23 Lycopodium, Ignatia amara PELLET ORAL 20150113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYCOPODIUM CLAVATUM SPORE; STRYCHNOS IGNATII SEED 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0024_5c612bcc-e8ef-818a-e053-2991aa0ab52c 69152-0024 HUMAN OTC DRUG Sivil 40 (Number 24) Ignatia Amara, Nux Vomica PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED 200; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0029_1023b43f-1b11-0eae-e054-00144ff88e88 69152-0029 HUMAN OTC DRUG Biracktam 40 (Number 29) Atropa Belladonna, Pulsatilla Nigricans PELLET ORAL 20141104 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC PULSATILLA PRATENSIS; ATROPA BELLADONNA 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0030_488a746d-750b-0b9d-e054-00144ff8d46c 69152-0030 HUMAN OTC DRUG Jakritin 40 (Number 30) Anacardium, Capsicum PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SEMECARPUS ANACARDIUM JUICE; CAPSICUM 200; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0031_100fd768-5043-06e6-e054-00144ff8d46c 69152-0031 HUMAN OTC DRUG Lungin 40 (Number 31) Chelidonium Majus, Allium Cepa PELLET ORAL 20141027 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CHELIDONIUM MAJUS; ONION 6; 200 [hp_X]/1; [hp_C]/1 E 20171231 69152-0033_410316cf-5c2e-195c-e054-00144ff8d46c 69152-0033 HUMAN OTC DRUG Sponcer 40 (Number 33) Arnica Montana, Kalmia Latifolia PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; KALMIA LATIFOLIA LEAF 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0034_1015dece-f0c3-1e13-e054-00144ff88e88 69152-0034 HUMAN OTC DRUG Ruman 40 (Number 34) Lycopodium clavatum, Nux Vomica PELLET ORAL 20141111 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0035_62fa5bf5-06cf-1add-e053-2a91aa0a6957 69152-0035 HUMAN OTC DRUG Bendin 40 (Number 35) Nux Vomica, Lycopodium Clavatum PELLET ORAL 20141104 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC STRYCHNOS NUX-VOMICA SEED; LYCOPODIUM CLAVATUM SPORE 200; 30 [hp_C]/1; [hp_C]/1 N 20191231 69152-0036_488a746d-7530-0b9d-e054-00144ff8d46c 69152-0036 HUMAN OTC DRUG Utom 40 Number 36 Sepia, Conium Maculatum, Thuja Occidentalis PELLET ORAL 20141031 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SEPIA OFFICINALIS JUICE; CONIUM MACULATUM FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG 200; 3; 200 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 69152-0038_4104d57b-f1af-442e-e054-00144ff88e88 69152-0038 HUMAN OTC DRUG Tamcon 40 (Number 38) Belladonna, Cimicifuga Racemosa PELLET ORAL 20141031 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; BLACK COHOSH 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0040_10252d90-57d8-2151-e054-00144ff8d46c 69152-0040 HUMAN OTC DRUG Pyrocom 40 (Number 40) Belladonna, Rhus toxicodendron PELLET ORAL 20141120 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0043_547eb093-5663-6073-e054-00144ff8d46c 69152-0043 HUMAN OTC DRUG Drosy 40 (Number 43) Gelsemium Sempervirens, Rhus Toxicodendron PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC GELSEMIUM SEMPERVIRENS ROOT; TOXICODENDRON PUBESCENS LEAF 6; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0044_4b4df0a9-d714-540a-e054-00144ff88e88 69152-0044 HUMAN OTC DRUG Bandblid 40 (Number 44) Arnica montana, Antimonium crudum PELLET ORAL 20141014 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; ANTIMONY TRISULFIDE 30; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0045_101e6d53-3df7-0d79-e054-00144ff8d46c 69152-0045 HUMAN OTC DRUG Spaskas 40 (Number 45) Calcarea Sulphurica, Atropa Belladonna PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; CALCIUM SULFATE ANHYDROUS 30; 6 [hp_C]/1; [hp_C]/1 E 20171231 69152-0046_40dcacfb-6915-56f2-e054-00144ff88e88 69152-0046 HUMAN OTC DRUG Galan 40 (Number 46) Belladonna, Argentum Metallicum PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SILVER; ATROPA BELLADONNA 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0047_104fd887-18dc-5395-e054-00144ff8d46c 69152-0047 HUMAN OTC DRUG Ghumer 40 (Number 47) Hyoscyamus Niger, Aurum Metallicum PELLET ORAL 20141023 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC HYOSCYAMUS NIGER; GOLD 6; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0048_488a746d-74fc-0b9d-e054-00144ff8d46c 69152-0048 HUMAN OTC DRUG Antina 40 (Number 48) Cimicifuga Racemosa Root, Bryonia Alba Root PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; BLACK COHOSH 200; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0049_410316cf-5c38-195c-e054-00144ff8d46c 69152-0049 HUMAN OTC DRUG Stibin 40 (Number 49) Coffea Cruda, Sepia PELLET ORAL 20141031 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SEPIA OFFICINALIS JUICE; ARABICA COFFEE BEAN 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0050_0fc6cad0-13dc-6aa9-e054-00144ff8d46c 69152-0050 HUMAN OTC DRUG Baman 40 (Number 50) Chelidonium Majus, Aethusa Cynapium PELLET ORAL 20141104 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CHELIDONIUM MAJUS; AETHUSA CYNAPIUM 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0051_0fee47d8-2e27-44c1-e054-00144ff88e88 69152-0051 HUMAN OTC DRUG Disprol 40 (Number 51) Bryonia Alba, Cimicifuga Racemosa PELLET ORAL 20141023 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; BLACK COHOSH 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0053_100fd768-503e-06e6-e054-00144ff8d46c 69152-0053 HUMAN OTC DRUG Lukis 40 (Number 53) Arsenicum album, Cimicifuga PELLET ORAL 20141108 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARSENIC TRIOXIDE; BLACK COHOSH 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0054_0fc5de18-b767-427b-e054-00144ff8d46c 69152-0054 HUMAN OTC DRUG Bijon 40 (Number 54) Cimicifuga Racemosa, Hypericum Perforatum PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BLACK COHOSH; HYPERICUM PERFORATUM 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0055_40f0313d-12f0-1d16-e054-00144ff88e88 69152-0055 HUMAN OTC DRUG Lipen 40 (Number 55) Potassium Carbonate, Bryonia Alba PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC POTASSIUM CARBONATE; BRYONIA ALBA ROOT 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0057_40f1401f-2b09-5b1b-e054-00144ff8d46c 69152-0057 HUMAN OTC DRUG Parinum 40 (Number 57) Atropa Belladonna, Arnica Montana PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; ARNICA MONTANA 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0058_10162a50-f014-4426-e054-00144ff88e88 69152-0058 HUMAN OTC DRUG Racktim 40 (Number 58) Nux Vomica, Podophyllum Peltatum PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC PODOPHYLLUM; STRYCHNOS NUX-VOMICA SEED 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0059_0fe190a6-94ad-2b86-e054-00144ff8d46c 69152-0059 HUMAN OTC DRUG Disfas 40 (Number 59) Phytolacca, Belladonna PELLET ORAL 20141022 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; PHYTOLACCA AMERICANA ROOT 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0060_10252d90-57d1-2151-e054-00144ff8d46c 69152-0060 HUMAN OTC DRUG Moutal 40 (Number 60) Calcarea sulphurica, Arsenicum album PELLET ORAL 20141027 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CALCIUM SULFATE ANHYDROUS; ARSENIC TRIOXIDE 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0062_10b26246-cbda-274e-e054-00144ff88e88 69152-0062 HUMAN OTC DRUG Danton 40 (Number 62) Mezereum, Atropa belladonaa PELLET ORAL 20141021 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC DAPHNE MEZEREUM BARK; ATROPA BELLADONNA 6; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0063_10d96ae3-340d-50b2-e054-00144ff88e88 69152-0063 HUMAN OTC DRUG Hemorin 40 (Number 63) Millefolium, Arnica Montana PELLET ORAL 20141024 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ACHILLEA MILLEFOLIUM; ARNICA MONTANA 6; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0064_10174af9-1dde-6781-e054-00144ff88e88 69152-0064 HUMAN OTC DRUG Sidni 40 (Number 64) Mercurius Solubilis, Silicea PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC MERCURIUS SOLUBILIS; SILICON DIOXIDE 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0065_40f0e1e5-7926-4a44-e054-00144ff8d46c 69152-0065 HUMAN OTC DRUG Panace 40 (Number 65) Capsicum, Lycopodium PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYCOPODIUM CLAVATUM SPORE; CAPSICUM 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0067_101685ab-f258-1fa8-e054-00144ff8d46c 69152-0067 HUMAN OTC DRUG Sisamo 40 (Number 67) Alumina, Bryonia Alba PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ALUMINUM OXIDE; BRYONIA ALBA ROOT 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0068_10aee40e-f4a5-3fd2-e054-00144ff8d46c 69152-0068 HUMAN OTC DRUG Dirin 40 (Number 68) Argentum nitricum, Pulsatilla nigricans PELLET ORAL 20141018 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC PULSATILLA PRATENSIS; SILVER NITRATE 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0069_62fa5bf5-06c5-1add-e053-2a91aa0a6957 69152-0069 HUMAN OTC DRUG Adikan 40 (Number 69) Podophyllum peltatum, Arsenicum album PELLET ORAL 20141010 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC PODOPHYLLUM; ARSENIC TRIOXIDE 30; 200 [hp_C]/1; [hp_C]/1 N 20191231 69152-0070_488a746d-7517-0b9d-e054-00144ff8d46c 69152-0070 HUMAN OTC DRUG Respen 40 (Number 70) Arnica Montana, Atropa Belladonna PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; ATROPA BELLADONNA 30; 30 [hp_C]/1; [hp_C]/1 N 20181231 69152-0071_118d0f91-6136-3016-e054-00144ff88e88 69152-0071 HUMAN OTC DRUG Inflo 40 Number 71 Conium maculatum, Sabina PELLET ORAL 20150318 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CONIUM MACULATUM FLOWERING TOP; JUNIPERUS SABINA LEAFY TWIG 30; 6 [hp_C]/1; [hp_C]/1 E 20171231 69152-0072_0f88a46a-848b-3f5b-e054-00144ff88e88 69152-0072 HUMAN OTC DRUG Amhed 40 (Number 72) Atropa Belladonna, Sepia PELLET ORAL 20141103 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; SEPIA OFFICINALIS JUICE 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0073_0fc6bd8a-154d-2c34-e054-00144ff88e88 69152-0073 HUMAN OTC DRUG Adipros 40 (number 73) Helonias chamaelirium, Mezereum PELLET ORAL 20141008 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CHAMAELIRIUM LUTEUM ROOT; DAPHNE MEZEREUM BARK 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0074_0f89d80e-c14a-0a7e-e054-00144ff8d46c 69152-0074 HUMAN OTC DRUG Triflo 40 Number 74 Kreosotum, Arnica montana PELLET ORAL 20150220 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC WOOD CREOSOTE; ARNICA MONTANA 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0075_0fc4a4b2-3431-5948-e054-00144ff88e88 69152-0075 HUMAN OTC DRUG Badispen 40 (Number 75) Caulophyllum thalictroides, Secale cornutum PELLET ORAL 20141010 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CAULOPHYLLUM THALICTROIDES ROOT; CLAVICEPS PURPUREA SCLEROTIUM 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0076_101e6d53-3df0-0d79-e054-00144ff8d46c 69152-0076 HUMAN OTC DRUG Sirpa 40 (Number 76) Rhus Toxicodendron, Atropa Belladonna PELLET ORAL 20141027 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC TOXICODENDRON PUBESCENS LEAF; ATROPA BELLADONNA 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0077_0f88a46a-8490-3f5b-e054-00144ff88e88 69152-0077 HUMAN OTC DRUG Tinnam 40 Number 77 Bryonia alba, Conium maculatum PELLET ORAL 20150220 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; CONIUM MACULATUM FLOWERING TOP 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0078_448aed61-d73f-2954-e054-00144ff8d46c 69152-0078 HUMAN OTC DRUG Haran 40 (Number 78) Arnica Montana, Ledum PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; LEDUM PALUSTRE TWIG 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0079_0eace184-f5ac-5d21-e054-00144ff8d46c 69152-0079 HUMAN OTC DRUG Birin 40 (Number 79) Bismuthum, Arsenicum album PELLET ORAL 20141030 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARSENIC TRIOXIDE; BISMUTH SUBNITRATE 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0080_4104d57b-f1ba-442e-e054-00144ff88e88 69152-0080 HUMAN OTC DRUG Trilif 40 (Number 80) Antimonium Crudum, Graphites PELLET ORAL 20141031 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; GRAPHITE 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0081_1177cf51-2c66-6e9d-e054-00144ff88e88 69152-0081 HUMAN OTC DRUG Novera 40 Number 81 Pulsatilla nigricans, Cantharis PELLET ORAL 20150317 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC PULSATILLA PRATENSIS; LYTTA VESICATORIA 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0082_488d9492-69ca-2936-e054-00144ff8d46c 69152-0082 HUMAN OTC DRUG Iodicin 40 Number 82 Iodium, Ipecacuanha PELLET ORAL 20150116 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC IODINE; IPECAC 200; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0085_1053fa6d-b52e-3017-e054-00144ff88e88 69152-0085 HUMAN OTC DRUG Endimo 40 Number 85 Thuja occidentalis, Natrum muriaticum PELLET ORAL 20150116 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC THUJA OCCIDENTALIS LEAFY TWIG; SODIUM CHLORIDE 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0086_528cad76-be81-6bd4-e054-00144ff88e88 69152-0086 HUMAN OTC DRUG Onepis 40 (Number 86) Bryonia Alba, Apis Mellifica PELLET ORAL 20141110 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; APIS MELLIFERA 200; 6 [hp_C]/1; [hp_C]/1 N 20181231 69152-0087_0ee86e15-c8d4-6b32-e054-00144ff8d46c 69152-0087 HUMAN OTC DRUG Takam 40 Number 87 Aurum metallicum, Nux moschata PELLET ORAL 20150114 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC GOLD; NUTMEG 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0088_0ef5f50c-1288-5c53-e054-00144ff8d46c 69152-0088 HUMAN OTC DRUG Olinj 40 Number 88 Cuprum metallicum, Rhus toxicodendron PELLET ORAL 20150213 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC COPPER; TOXICODENDRON PUBESCENS LEAF 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0089_10da481d-cee1-5afe-e054-00144ff88e88 69152-0089 HUMAN OTC DRUG Stoul 40 (Number 89) Iris Versicolor, Arsenicum Album PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC IRIS VERSICOLOR ROOT; ARSENIC TRIOXIDE 30; 3 [hp_C]/1; [hp_C]/1 E 20171231 69152-0090_0fed8b5f-c0a1-3684-e054-00144ff8d46c 69152-0090 HUMAN OTC DRUG Hardmet Car 40 (Number 90) Argentum Nitricum, Aurum Metallicum PELLET ORAL 20141104 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SILVER NITRATE; GOLD 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0092_10d96ae3-3407-50b2-e054-00144ff88e88 69152-0092 HUMAN OTC DRUG Gallkid 40 (Number 92) Sarsaparilla, Tabacum PELLET ORAL 20141024 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SMILAX REGELII ROOT; TOBACCO LEAF 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0093_0ec08d51-87ac-5bcd-e054-00144ff8d46c 69152-0093 HUMAN OTC DRUG Poisthum 40 (Number 93) Ipecacuanha, Bismuthum Subnitricum PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC IPECAC; BISMUTH SUBNITRATE 200; 6 [hp_C]/1; [hp_C]/1 E 20171231 69152-0094_0ee6b51b-ba2a-20e0-e054-00144ff8d46c 69152-0094 HUMAN OTC DRUG Showha 40 Number 94 Calcarea sulphurica, Antimonium crudum PELLET ORAL 20150113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CALCIUM SULFATE ANHYDROUS; ANTIMONY TRISULFIDE 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0095_40ddd93c-bcf9-6b65-e054-00144ff88e88 69152-0095 HUMAN OTC DRUG Goitum 40 Number 95 Thuja occidentalis, Graphites PELLET ORAL 20150318 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC THUJA OCCIDENTALIS LEAFY TWIG; GRAPHITE 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0097_4b4f02c6-95d9-4548-e054-00144ff8d46c 69152-0097 HUMAN OTC DRUG Gardenium 40 Number 97 Belladonna, Mercurius corrosivus PELLET ORAL 20150115 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; MERCURIC CHLORIDE 30; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0100_547fc70a-f7f6-32d6-e054-00144ff8d46c 69152-0100 HUMAN OTC DRUG Sikrim 40 Number 100 Mercurius corrosivus, Chelidonium majus PELLET ORAL 20150114 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC MERCURIC CHLORIDE; CHELIDONIUM MAJUS 200; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0104_101685ab-f27a-1fa8-e054-00144ff8d46c 69152-0104 HUMAN OTC DRUG Sloth 40 (Number 104) Argentum Metallicum, Rhus Toxicodendron PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SILVER NITRATE; TOXICODENDRON PUBESCENS LEAF 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0105_101685ab-f26f-1fa8-e054-00144ff8d46c 69152-0105 HUMAN OTC DRUG Softcarb 40 (Number 105) Antimonium Crudum, Arsenicum Album PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARSENIC TRIOXIDE; ANTIMONY TRISULFIDE 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0107_100f7e6f-d030-3dda-e054-00144ff88e88 69152-0107 HUMAN OTC DRUG Inkar 40 (Number 107) Blatta Orientalis, Ipecacuanha PELLET ORAL 20141104 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BLATTA ORIENTALIS; IPECAC 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0110_40dc9e39-f058-16a4-e054-00144ff8d46c 69152-0110 HUMAN OTC DRUG Alpan 40 (Number 110) Nux Vomica 200C HPUS, Bryonia Alba Root 30C PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC STRYCHNOS NUX-VOMICA SEED; BRYONIA ALBA ROOT 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0111_10250fda-6205-1756-e054-00144ff8d46c 69152-0111 HUMAN OTC DRUG Ginos 40 (Number 111) Conium Maculatum, Ignatia Amara PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CONIUM MACULATUM FLOWERING TOP; STRYCHNOS IGNATII SEED 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0113_1053fa6d-b527-3017-e054-00144ff88e88 69152-0113 HUMAN OTC DRUG Drich 40 (Number 113) Antimonium crudum, Hepar sulphuris calcareum PELLET ORAL 20141205 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; CALCIUM SULFIDE 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0114_50e3961d-8258-31be-e054-00144ff8d46c 69152-0114 HUMAN OTC DRUG Comsal 40 (Number 114) Platinum metallicum, Medorrhinum PELLET ORAL 20141014 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC PLATINUM; GONORRHEAL URETHRAL SECRETION HUMAN 30; 30 [hp_C]/1; [hp_C]/1 N 20181231 69152-0116_113f1e43-bf20-123c-e054-00144ff8d46c 69152-0116 HUMAN OTC DRUG Mucasid 40 Number 116 Calendula officinalis, Mercurius solubilis PELLET ORAL 20150317 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CALENDULA OFFICINALIS FLOWERING TOP; MERCURIUS SOLUBILIS 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0118_11792759-3aa7-03a8-e054-00144ff8d46c 69152-0118 HUMAN OTC DRUG Gasol 40 Number 118 Sarsaparilla, Arsenicum album PELLET ORAL 20150317 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SMILAX REGELII ROOT; ARSENIC TRIOXIDE 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0119_10525646-c9dd-3d01-e054-00144ff8d46c 69152-0119 HUMAN OTC DRUG Glowin 40 (Number 119) Secale Cornutum, Phosphorus PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CLAVICEPS PURPUREA SCLEROTIUM; PHOSPHORUS 30; 6 [hp_C]/1; [hp_C]/1 E 20171231 69152-0120_0ec08d51-87bc-5bcd-e054-00144ff8d46c 69152-0120 HUMAN OTC DRUG Npto 40 (Number 120) Arnica Montana, Graphites PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; GRAPHITE 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0123_101758cf-9fb7-44b8-e054-00144ff8d46c 69152-0123 HUMAN OTC DRUG Sadaton 40 (Number 123) Bryonia Alba, Belladonna PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; ATROPA BELLADONNA 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0125_107c6090-9205-571d-e054-00144ff8d46c 69152-0125 HUMAN OTC DRUG Adinos 40 (Number 125) Lycopodium Clavatum, Ipecacuanha PELLET ORAL 20141009 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYCOPODIUM CLAVATUM SPORE; IPECAC 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0126_118ea9ca-c33f-062e-e054-00144ff88e88 69152-0126 HUMAN OTC DRUG Femolin 40 Number 126 Ignatia amara, Sepia PELLET ORAL 20150318 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC STRYCHNOS IGNATII SEED; SEPIA OFFICINALIS JUICE 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0128_1015dece-f0bd-1e13-e054-00144ff88e88 69152-0128 HUMAN OTC DRUG Penpil 40 (Number 128) Sulphur, Atropa Belladonna PELLET ORAL 20141111 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SULFUR; ATROPA BELLADONNA 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0134_113f7b6d-34c1-1a0c-e054-00144ff8d46c 69152-0134 HUMAN OTC DRUG Karat 40 Number 134 Conium maculatum, Bryonia alba PELLET ORAL 20150314 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CONIUM MACULATUM FLOWERING TOP; BRYONIA ALBA ROOT 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0136_107c6090-9212-571d-e054-00144ff8d46c 69152-0136 HUMAN OTC DRUG Bishala 40 (Number 136) Hypericum perforatum, Arnica montana PELLET ORAL 20141010 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC HYPERICUM PERFORATUM; ARNICA MONTANA 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0137_0f9a9303-8da9-446e-e054-00144ff8d46c 69152-0137 HUMAN OTC DRUG Yelos 40 Number 137 Psorinum, Bryonia alba PELLET ORAL 20150221 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SCABIES LESION LYSATE (HUMAN); BRYONIA ALBA ROOT 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0139_40f0313d-12fe-1d16-e054-00144ff88e88 69152-0139 HUMAN OTC DRUG Makros 40 (Number 139) Chamomilla, Arsenicum album PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC MATRICARIA RECUTITA; ARSENIC TRIOXIDE 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0140_0f993d38-7b4a-143c-e054-00144ff8d46c 69152-0140 HUMAN OTC DRUG Uriblo 40 Number 140 Arnica montana, Cantharis PELLET ORAL 20150221 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; LYTTA VESICATORIA 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0141_10661068-235b-7214-e054-00144ff88e88 69152-0141 HUMAN OTC DRUG Maruv 40 Number 141 Cina, Lycopodium clavatum PELLET ORAL 20150117 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYCOPODIUM CLAVATUM SPORE; ARTEMISIA CINA PRE-FLOWERING TOP 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0143_10b26246-cbd5-274e-e054-00144ff88e88 69152-0143 HUMAN OTC DRUG Fludblid 40 (Number 143) Cimicifuga Racemosa, Bovista PELLET ORAL 20141023 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BLACK COHOSH; LYCOPERDON UTRIFORME FRUITING BODY 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0501_0eace184-f5a6-5d21-e054-00144ff8d46c 69152-0501 HUMAN OTC DRUG Bacnos 40 (Number 501) Mezereum, Graphites PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC GRAPHITE; DAPHNE MEZEREUM BARK 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0503_1054c38a-81b7-2704-e054-00144ff8d46c 69152-0503 HUMAN OTC DRUG Honby 40 Number 503 Caulophyllum thalictroides, Sepia PELLET ORAL 20150115 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CAULOPHYLLUM THALICTROIDES ROOT; SEPIA OFFICINALIS JUICE 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0506_10679e92-6f86-526c-e054-00144ff8d46c 69152-0506 HUMAN OTC DRUG Rattle 40 (Number 506) Bryonia Alba, Ipecacuanha PELLET ORAL 20141111 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC IPECAC; BRYONIA ALBA ROOT 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0507_20e0739a-31a0-3af2-e054-00144ff8d46c 69152-0507 HUMAN OTC DRUG Trigon 40 (Number 507) Belladonna, Ignatia amara PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; STRYCHNOS IGNATII SEED 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0508_50e33053-55e9-29f8-e054-00144ff8d46c 69152-0508 HUMAN OTC DRUG Bitu 40 (Number 508) Antimonium crudum, Ruta graveolens PELLET ORAL 20141030 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ANTIMONY TRISULFIDE; RUTA GRAVEOLENS FLOWERING TOP 30; 6 [hp_C]/1; [hp_C]/1 N 20181231 69152-0509_6309a7be-7ad3-bfe4-e053-2a91aa0ac210 69152-0509 HUMAN OTC DRUG Polyfit 40 Number 509 Arnica montana, Absinthium PELLET ORAL 20150212 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; WORMWOOD 200; 6 [hp_C]/1; [hp_C]/1 N 20191231 69152-0510_0fc60597-a441-1a0f-e054-00144ff88e88 69152-0510 HUMAN OTC DRUG Conpil 40 (Number 510) Conium maculatum, Nux vomica PELLET ORAL 20141018 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CONIUM MACULATUM FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0515_331af44d-2df5-0843-e054-00144ff88e88 69152-0515 HUMAN OTC DRUG Delivin 40 Number 515 Caulophyllum thalictroides, Sepia PELLET ORAL 20150319 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CAULOPHYLLUM THALICTROIDES ROOT; SEPIA OFFICINALIS JUICE 6; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0519_48918d27-95f1-1d55-e054-00144ff8d46c 69152-0519 HUMAN OTC DRUG Klothem (Number 519) Pulsatilla nigricans, Belladonna PELLET ORAL 20141106 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC PULSATILLA PRATENSIS; ATROPA BELLADONNA 30; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0520_643c79d8-2b76-d635-e053-2991aa0a2d59 69152-0520 HUMAN OTC DRUG Phitinum 40 (Number 520) Atropa Belladonna, Sanguinaria PELLET ORAL 20141027 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; SANGUINARIA CANADENSIS ROOT 200; 30 [hp_C]/1; [hp_C]/1 N 20191231 69152-0521_0f88c98b-750d-37dd-e054-00144ff88e88 69152-0521 HUMAN OTC DRUG Ulcol 40 Number 521 Pulsatilla nigricans, Bryonia alba PELLET ORAL 20150221 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; PULSATILLA PRATENSIS 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0524_50e23c08-7331-6d1a-e054-00144ff8d46c 69152-0524 HUMAN OTC DRUG Alartem 40 (Number 524) Artemisia Vulgaris, Cuprum Metallicum PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARTEMISIA VULGARIS ROOT; COPPER 6; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0527_10b26246-cbe3-274e-e054-00144ff88e88 69152-0527 HUMAN OTC DRUG Ames 40 (Number 527) Veratrum Album, Mercurius Solubilis PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC VERATRUM ALBUM ROOT; MERCURIUS SOLUBILIS 30; 6 [hp_C]/1; [hp_C]/1 E 20171231 69152-0528_488c0826-afb5-5411-e054-00144ff8d46c 69152-0528 HUMAN OTC DRUG Anchin 40 (Number 528) ACONITUM NAPELLUS,CONIUM MACULATUM PELLET ORAL 20140926 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences ACONITUM NAPELLUS; CONIUM MACULATUM FLOWERING TOP 30; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0532_1023b43f-1b0c-0eae-e054-00144ff88e88 69152-0532 HUMAN OTC DRUG Batinha 40 (Number 532) Hypericum peltatum, Arsenicum album PELLET ORAL 20141010 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC HYPERICUM PERFORATUM; KALMIA LATIFOLIA LEAF 30; 6 [hp_C]/1; [hp_C]/1 E 20171231 69152-0536_1053fa6d-b522-3017-e054-00144ff88e88 69152-0536 HUMAN OTC DRUG Blith 40 (Number 536) Lithium carbonicum, Rhus toxicodendron PELLET ORAL 20141121 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LITHIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF 6; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0537_1051948c-fb4a-5447-e054-00144ff88e88 69152-0537 HUMAN OTC DRUG Bontu 40 (Number 537) Arnica montana, Calcarea phosphorica PELLET ORAL 20141030 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC TRIBASIC CALCIUM PHOSPHATE; ARNICA MONTANA 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0539_1023b43f-1b16-0eae-e054-00144ff88e88 69152-0539 HUMAN OTC DRUG Buchap 40 (Number 539) Bryonia alba, Arnica montana PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; ARNICA MONTANA 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0544_4104d57b-f1c9-442e-e054-00144ff88e88 69152-0544 HUMAN OTC DRUG Chinibes 40 (Number 544) Lycopodium clavatum, Chelidonium majus PELLET ORAL 20141018 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYCOPODIUM CLAVATUM SPORE; CHELIDONIUM MAJUS 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0546_107ce18f-17b0-6f77-e054-00144ff88e88 69152-0546 HUMAN OTC DRUG Chulin 40 (Number 546) Graphites, Lycopodium Clavatum PELLET ORAL 20141017 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC GRAPHITE; LYCOPODIUM CLAVATUM SPORE 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0548_62fa2682-913e-57c1-e053-2a91aa0a8546 69152-0548 HUMAN OTC DRUG Cytopan 40 (Number 548) Arnica Montana, Rhus Toxicodendron PELLET ORAL 20141023 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; TOXICODENDRON PUBESCENS LEAF 30; 200 [hp_C]/1; [hp_C]/1 N 20191231 69152-0552_4b4e53e1-64cf-2438-e054-00144ff8d46c 69152-0552 HUMAN OTC DRUG Dorspi 40 (Number 552) Rhus toxicodendron, Bryonia alba PELLET ORAL 20141021 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; TOXICODENDRON PUBESCENS LEAF 30; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0553_107bdf31-31aa-44c7-e054-00144ff8d46c 69152-0553 HUMAN OTC DRUG Eutopa 40 (Number 553 Sepia, Aurum Metallicum PELLET ORAL 20141023 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SEPIA OFFICINALIS JUICE; GOLD 6; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0556_10aee40e-f4a1-3fd2-e054-00144ff8d46c 69152-0556 HUMAN OTC DRUG Gallchi 40 (Number 556) Nux Vomica, Cinchona Officinalis PELLET ORAL 20141023 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CINCHONA OFFICINALIS BARK; STRYCHNOS NUX-VOMICA SEED 6; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0567_11a4f560-2aee-187e-e054-00144ff8d46c 69152-0567 HUMAN OTC DRUG Incollins 40 Number 567 Belladonna, Magnesium phosphoricum PELLET ORAL 20150319 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0568_0feec3fb-a668-529b-e054-00144ff88e88 69152-0568 HUMAN OTC DRUG Indigit 40 (Number 568) Arnica montana, Aconitum napellus PELLET ORAL 20141119 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; ACONITUM NAPELLUS 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0569_10679e92-6f90-526c-e054-00144ff8d46c 69152-0569 HUMAN OTC DRUG Iriphos 40 Number 569 Arnica montana, Acidum phosphoricum PELLET ORAL 20150116 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARNICA MONTANA; PHOSPHORIC ACID 30; 6 [hp_C]/1; [hp_C]/1 E 20171231 69152-0570_100fd768-5031-06e6-e054-00144ff8d46c 69152-0570 HUMAN OTC DRUG Jalpet 40 (Number 570) Capsicum Annuum, Arsenicum Album PELLET ORAL 20141024 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC CAPSICUM; ARSENIC TRIOXIDE 200; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0571_10525646-c9e2-3d01-e054-00144ff8d46c 69152-0571 HUMAN OTC DRUG Jarin 40 (Number 571) Belladonna, Bryonia alba PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; BRYONIA ALBA ROOT 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0579_10f0ed2b-2577-5185-e054-00144ff8d46c 69152-0579 HUMAN OTC DRUG Lim 40 Number 579 Argentum metallicum, Caladium seguinum PELLET ORAL 20150310 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC DIEFFENBACHIA SEGUINE; SILVER 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0581_547fc70a-f7eb-32d6-e054-00144ff8d46c 69152-0581 HUMAN OTC DRUG Lookal 40 Number 581 Bryonia alba, Carbo vegetabilis PELLET ORAL 20150117 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; ACTIVATED CHARCOAL 30; 30 [hp_C]/1; [hp_C]/1 N 20181231 69152-0590_488d9492-69da-2936-e054-00144ff8d46c 69152-0590 HUMAN OTC DRUG Nimelia 40 Number 590 Thuja occidentalis, Colchicum autumnale PELLET ORAL 20150213 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC THUJA OCCIDENTALIS LEAFY TWIG; COLCHICUM AUTUMNALE BULB 30; 200 [hp_C]/1; [hp_C]/1 N 20181231 69152-0598_4b63702f-c135-4149-e054-00144ff8d46c 69152-0598 HUMAN OTC DRUG Pitamarin 40 (Number 598) Lycopodium Clavatum, Berberis Vulgaris PELLET ORAL 20141027 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYCOPODIUM CLAVATUM SPORE; BERBERIS VULGARIS ROOT BARK 30; 30 [hp_C]/1; [hp_C]/1 N 20181231 69152-0600_5043ad1a-ee39-14ed-e054-00144ff88e88 69152-0600 HUMAN OTC DRUG Pureja 40 Number 600 Pulsatilla nigricans, Cantharis PELLET ORAL 20150323 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC PULSATILLA PRATENSIS; LYTTA VESICATORIA 200; 6 [hp_C]/1; [hp_C]/1 N 20181231 69152-0603_410316cf-5c47-195c-e054-00144ff8d46c 69152-0603 HUMAN OTC DRUG Sar 40 (Number 603) Bryonia Alba, Lycopodium Clavatum PELLET ORAL 20141029 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYCOPODIUM CLAVATUM SPORE; BRYONIA ALBA ROOT 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0606_101685ab-f274-1fa8-e054-00144ff8d46c 69152-0606 HUMAN OTC DRUG Sodanum 40 (Number 606) Cantharis, Rhus Toxicodendron PELLET ORAL 20141113 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC LYTTA VESICATORIA; TOXICODENDRON PUBESCENS LEAF 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0610_4141dcfe-2477-1ed8-e054-00144ff88e88 69152-0610 HUMAN OTC DRUG Trisulin 40 Number 610 Natrum muriaticum, Thuja occidentalis PELLET ORAL 20150310 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG 200; 6 [hp_C]/1; [hp_C]/1 E 20171231 69152-0611_5d50b3b3-cf0d-1d10-e053-2a91aa0a6de6 69152-0611 HUMAN OTC DRUG Violin 40 Number 611 Cicuta virosa, Hypericum perforatum PELLET ORAL 20150311 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC HYPERICUM PERFORATUM; CICUTA VIROSA ROOT 30; 30 [hp_C]/1; [hp_C]/1 N 20181231 69152-0614_0eabe839-c58d-669c-e054-00144ff88e88 69152-0614 HUMAN OTC DRUG Ameno 40 (Number 614) Sepia, Bryonia Alba PELLET ORAL 20141028 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC SEPIA OFFICINALIS JUICE; BRYONIA ALBA ROOT 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0615_10d96ae3-3412-50b2-e054-00144ff88e88 69152-0615 HUMAN OTC DRUG Kanmet 40 (Number 615) Chamomilla, Belladonna PELLET ORAL 20141024 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC MATRICARIA RECUTITA; ATROPA BELLADONNA 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0616_1053fa6d-b532-3017-e054-00144ff88e88 69152-0616 HUMAN OTC DRUG Eleptan 40 Number 616 Bryonia alba, Chamomilla PELLET ORAL 20150114 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; MATRICARIA RECUTITA 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0623_11178f9a-f66e-5635-e054-00144ff88e88 69152-0623 HUMAN OTC DRUG Euphrasia 40 Number 623 Allium cepa, Lycopodium clavatum PELLET ORAL 20150312 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ONION; LYCOPODIUM CLAVATUM SPORE 30; 200 [hp_C]/1; [hp_C]/1 E 20171231 69152-0631_0ed4debd-2e6f-720b-e054-00144ff88e88 69152-0631 HUMAN OTC DRUG Orcon 40 Number 631 Hamamelis virginiana, Aurum metallicum PELLET ORAL 20150211 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; GOLD 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0633_0efcbacb-1d03-112d-e054-00144ff8d46c 69152-0633 HUMAN OTC DRUG Thalibin 40 Number 633 Bryonia alba, Arnica montana PELLET ORAL 20150213 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; ARNICA MONTANA 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0636_1051948c-fb59-5447-e054-00144ff88e88 69152-0636 HUMAN OTC DRUG DECF 40 Number 636 Rhus toxicodendron, Bryonia alba PELLET ORAL 20150108 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC TOXICODENDRON PUBESCENS LEAF; BRYONIA ALBA ROOT 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0637_331b7251-a776-17c6-e054-00144ff88e88 69152-0637 HUMAN OTC DRUG Muspen 40 Number 637 Cimicifuga racemosa, Symphytum Officinale PELLET ORAL 20150325 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BLACK COHOSH; COMFREY ROOT 30; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0638_121c6a0c-42a0-0c83-e054-00144ff88e88 69152-0638 HUMAN OTC DRUG Diabins 40 Number 638 Rhus toxicodendron, Lycopodium clavatum PELLET ORAL 20150107 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC TOXICODENDRON PUBESCENS LEAF; LYCOPODIUM CLAVATUM SPORE 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0639_0efc1c29-643e-6fd4-e054-00144ff8d46c 69152-0639 HUMAN OTC DRUG Onefit 40 Number 639 Belladonna, Gelsemium PELLET ORAL 20150107 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT 200; 30 [hp_C]/1; [hp_C]/1 E 20171231 69152-0640_631df0fd-4148-4c4d-e053-2a91aa0ac4f4 69152-0640 HUMAN OTC DRUG Oneref 40 Number 640 Bryonia alba, Colchicum PELLET ORAL 20150107 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB 200; 200 [hp_C]/1; [hp_C]/1 N 20191231 69152-0641_10520941-4c75-3133-e054-00144ff8d46c 69152-0641 HUMAN OTC DRUG Cardiomyo 40 Number 641 Rhus toxicodendron, Arnica montana PELLET ORAL 20150107 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA 200; 30 [hp_C]/1; 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Calcarea phosphorica PELLET ORAL 20141218 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC TRIBASIC CALCIUM PHOSPHATE 3 [hp_X]/1 E 20171231 69152-1550_4a4de8b6-d3d1-1a1e-e054-00144ff8d46c 69152-1550 HUMAN OTC DRUG Eupatorium perfoliatum 1X Eupatorium perfoliatum LIQUID ORAL 20150401 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC EUPATORIUM PERFOLIATUM FLOWERING TOP 1 [hp_X]/8mL N 20181231 69152-1551_4a5cfd87-418c-2d09-e054-00144ff8d46c 69152-1551 HUMAN OTC DRUG Carduus marianus 1X Carduus marianus LIQUID ORAL 20150509 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC MILK THISTLE 1 [hp_X]/8mL N 20181231 69152-1552_1e232c93-4a1a-37c6-e054-00144ff88e88 69152-1552 HUMAN PRESCRIPTION DRUG Berberis vulgaris 1X Berberis vulgaris LIQUID ORAL 20150604 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC BERBERIS VULGARIS ROOT BARK 1 [hp_X]/8mL E 20171231 69152-1553_17c2c1b4-bf21-6e61-e054-00144ff8d46c 69152-1553 HUMAN PRESCRIPTION DRUG Syzygium jambolanum 1X 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E 20171231 69152-1574_1695b8e1-79c3-5975-e054-00144ff88e88 69152-1574 HUMAN OTC DRUG Artemisia vulgaris 1X Artemisia vulgaris LIQUID ORAL 20150509 UNAPPROVED HOMEOPATHIC Paramesh Banerji Life Sciences LLC ARTEMISIA VULGARIS ROOT 1 [hp_X]/8mL E 20171231 69153-010_d5b7b377-f5af-4609-8b08-63c87839946d 69153-010 HUMAN OTC DRUG HERBAL DAHUIN BEAUTY OATMEAL SOAP TOPICAL 20140801 OTC MONOGRAPH FINAL part347 AN Co Ltd. OATMEAL .007 g/31 N 20181231 69153-020_14071c01-e34f-403a-9507-03617782ad7a 69153-020 HUMAN OTC DRUG AN ADC FACE UP SPECIAL PROGRAM OATMEAL SOLUTION TOPICAL 20140801 OTC MONOGRAPH FINAL part347 AN Co Ltd. OATMEAL .00007 mg/101 N 20181231 69153-030_8dbe6c83-21fc-4d2a-87fa-0c0515bf859b 69153-030 HUMAN OTC DRUG AN ADC EGF WRINKLE EYE Glycerin CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 AN Co Ltd. GLYCERIN 5 g/25g N 20181231 69153-040_5177928d-3c59-4b3d-b93a-66af8347b5f5 69153-040 HUMAN OTC DRUG AN ADC WHITENING ESSENCE OATMEAL CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 AN Co Ltd. OATMEAL .003 g/55g N 20181231 69153-050_55f3cbd5-f186-44da-b9c1-fdd7e1cec6a2 69153-050 HUMAN OTC DRUG AN ADC WRINKLE Dimethicone CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 AN Co Ltd. DIMETHICONE .65 g/50g N 20181231 69153-060_cd5c1ea8-b21c-4438-8056-fa8147417a35 69153-060 HUMAN OTC DRUG AN ADC WHITENING BB Titanium Dioxide CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 AN Co Ltd. TITANIUM DIOXIDE 2.6 g/50g N 20181231 69153-070_e24c99df-b9e9-4c67-a472-1371e9d75b81 69153-070 HUMAN OTC DRUG AN ADC SP F Adenosine SOLUTION TOPICAL 20160501 UNAPPROVED DRUG OTHER AN Co Ltd. ADENOSINE 2.8 mg/7mL N 20181231 69153-080_9a5141e2-b665-429e-b13d-82a7e84779b4 69153-080 HUMAN OTC DRUG AN ADC SP INTENSIVE MOISTURE ESSENCE Niacinamide CREAM TOPICAL 20160501 UNAPPROVED DRUG OTHER AN Co Ltd. NIACINAMIDE 1.1 g/55g N 20181231 69153-090_05e1f5a1-7764-4cf0-9cca-6c3f0c1d174a 69153-090 HUMAN OTC DRUG AN ADC SP INTENSIVE WRINKLE EYE Glycerin CREAM TOPICAL 20160501 OTC MONOGRAPH FINAL part347 AN Co Ltd. GLYCERIN 8.81 g/25g N 20181231 69153-100_608b9fe3-2c34-4da4-868b-00badce3656c 69153-100 HUMAN OTC DRUG AN ADC SP INTENSIVE WRINKLE Dimethicone CREAM TOPICAL 20160501 OTC MONOGRAPH FINAL part347 AN Co Ltd. DIMETHICONE .65 g/50g N 20181231 69153-110_ebae5e45-cea2-4506-9397-40641a6c45fd 69153-110 HUMAN OTC DRUG AN ADC SP INTENSIVE BB Titanium Dioxide CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 AN Co Ltd. TITANIUM DIOXIDE 1.72 g/50g N 20181231 69153-120_1240e625-d815-47c2-8c98-8fa297fa609b 69153-120 HUMAN OTC DRUG AN TOOTH SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20170201 OTC MONOGRAPH FINAL part355 AN Co Ltd. SODIUM MONOFLUOROPHOSPHATE .016 g/160g N 20181231 69153-130_c3e7e3e2-d5bd-4bd5-a757-18e3c0de1765 69153-130 HUMAN OTC DRUG All Nations A D C Special Program Adenosine SOLUTION TOPICAL 20170601 UNAPPROVED DRUG OTHER AN Co Ltd. ADENOSINE .002 g/6mL N 20181231 69154-010_e8ad9ea3-a238-48f5-be2a-5e3629f721d3 69154-010 HUMAN OTC DRUG THE YEON CMK PORE BLEMISH BC 01 PINK BEIGE TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 The Yeon Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE 2.11; .9 g/12g; g/12g E 20171231 69154-020_d58fae40-f56b-4eb9-8a4c-0d4059624d1a 69154-020 HUMAN OTC DRUG THE YEON CMK PORE BLEMISH BC 02 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 The Yeon Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE 2.11; .9 g/12g; g/12g E 20171231 69157-001_331b154b-d4aa-49e7-87b0-a4c9f81b9b73 69157-001 HUMAN OTC DRUG Berry Scented Hand Sanitizer Cars Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE .06 mg/59mg E 20171231 69157-002_bbfc8ff2-b9ee-4dbd-9c2f-4f20f593fd83 69157-002 HUMAN OTC DRUG Fruit Punch Scented Hand Sanitizer Frozen Benzalkonium Chloride GEL TOPICAL 20140603 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-003_4dd986bc-1711-45e9-964c-11af15074897 69157-003 HUMAN OTC DRUG Berry Scented Hand Sanitizer Girl Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE .06 mg/59mg E 20171231 69157-004_4b65e437-4109-44d2-ad3f-88e373eb803b 69157-004 HUMAN OTC DRUG Berry Scented Hand Sanitizer Mickey Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE .06 mg/59mg E 20171231 69157-005_dc551110-2fb1-4ce0-a27d-41d872c65e26 69157-005 HUMAN OTC DRUG Berry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-006_8143eff9-9f71-4a9a-8f81-adc28ecbf12d 69157-006 HUMAN OTC DRUG Berry Scented Hand Sanitizer Minnie Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE .06 mg/59mg E 20171231 69157-008_96a2aa70-ae62-4f04-b456-82fe64c976e7 69157-008 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-009_a71fa212-57aa-49f1-83f5-170b7dd76939 69157-009 HUMAN OTC DRUG Berry Scented Hand Sanitizer Princesses Benzalkonium Chloride GEL TOPICAL 20130529 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE .06 mg/59mg E 20171231 69157-010_fceca53d-2006-4c46-906f-e5ff4bf0e7dc 69157-010 HUMAN OTC DRUG Raspberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-013_6c8dcd16-cd29-4b65-b639-59e2cf43e188 69157-013 HUMAN OTC DRUG Cotton Candy Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-014_98054016-0c83-45b5-b885-2d57b17bcc81 69157-014 HUMAN OTC DRUG Cotton Candy Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-015_ca96369c-6dc6-4596-a434-452bbf45bbf1 69157-015 HUMAN OTC DRUG Cotton Candy Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-016_0efe20b0-28b0-4e8a-a82b-877351d7bb95 69157-016 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-017_1d13518c-e763-43b6-8490-3840151532a3 69157-017 HUMAN OTC DRUG Bubble Gum Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-018_1d876894-9a59-4044-9e7f-c3323dc4e1ca 69157-018 HUMAN OTC DRUG Raspberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-019_64aa7e84-c4b3-4b41-aed2-ad65a1e365ca 69157-019 HUMAN OTC DRUG Cotton Candy Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-020_6fa46895-31d6-4eb1-bd0b-2a42eb838389 69157-020 HUMAN OTC DRUG Boov-El Gum Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-021_708bd621-82a2-4264-83ae-8ae04e2eb135 69157-021 HUMAN OTC DRUG Fruit Punch Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-022_3dc4d080-9f59-4e2d-b581-c8d945b415b0 69157-022 HUMAN OTC DRUG Grape Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-023_68139abc-6717-48b0-a137-67a414487f65 69157-023 HUMAN OTC DRUG Bubble Gum Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-024_e5780cac-7d3a-4f5d-8ec8-055bc6e33426 69157-024 HUMAN OTC DRUG Berry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-025_c6263630-4ca1-45dc-8e3f-241edc07aca5 69157-025 HUMAN OTC DRUG Strawberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69157-026_ccc20960-b1bd-4292-b436-7866a36772d4 69157-026 HUMAN OTC DRUG Mixed Berries Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Nanhai Jinxiong Toys C o., Ltd BENZALKONIUM CHLORIDE 1 g/59g E 20171231 69158-000_3171e373-6375-4467-b3f0-872e9221a773 69158-000 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET, FILM COATED ORAL 19771121 ANDA ANDA085969 GLENVIEW PHARMA INC. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69158-001_3171e373-6375-4467-b3f0-872e9221a773 69158-001 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19771121 ANDA ANDA085966 GLENVIEW PHARMA INC. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69158-002_3171e373-6375-4467-b3f0-872e9221a773 69158-002 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 19771129 ANDA ANDA085968 GLENVIEW PHARMA INC. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69158-003_baeb6724-4be7-43cb-9271-a4ceb28bcefb 69158-003 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328 ANDA ANDA074532 GLENVIEW PHARMA INC. CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69158-004_baeb6724-4be7-43cb-9271-a4ceb28bcefb 69158-004 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328 ANDA ANDA074532 GLENVIEW PHARMA INC. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69158-005_baeb6724-4be7-43cb-9271-a4ceb28bcefb 69158-005 HUMAN PRESCRIPTION DRUG CAPTOPRIL CAPTOPRIL TABLET ORAL 19970328 ANDA ANDA074532 GLENVIEW PHARMA INC. CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69159-003_5b1fb8e5-c303-9a32-e053-2a91aa0a7f5a 69159-003 HUMAN OTC DRUG Lidocaine Patch Lidocaine PATCH TOPICAL 20170911 OTC MONOGRAPH NOT FINAL part348 Foshan Aqua Gel Biotech Co., Ltd., LIDOCAINE 40 mg/1 N 20181231 69159-004_5b1ffe32-1642-35e3-e053-2991aa0a7d8b 69159-004 HUMAN OTC DRUG HOT COLD LIDOCAINE WITH MENTHOL LIDOCAINE, MENTHOL PATCH TOPICAL 20170911 OTC MONOGRAPH NOT FINAL part348 Foshan Aqua Gel Biotech Co., Ltd., LIDOCAINE; MENTHOL 40; 10 mg/1; mg/1 N 20181231 69159-100_8c11b9d5-2ef4-411c-84c3-7c9ccf06ae11 69159-100 HUMAN OTC DRUG Assured Pain Relief LIDOCAINE GEL TOPICAL 20170820 OTC MONOGRAPH NOT FINAL part348 Foshan Aqua Gel Biotech Co., Ltd., LIDOCAINE 4 g/100g N 20181231 69159-101_4d8b9c76-3f7f-4e19-b58c-1be1aa9bc456 69159-101 HUMAN OTC DRUG Assured Pain Relief LIDOCAINE KIT 20170820 OTC MONOGRAPH NOT FINAL part348 Foshan Aqua Gel Biotech Co., Ltd., N 20181231 69159-300_2759dbc7-9596-4f2b-a3cf-f616d48b9006 69159-300 HUMAN OTC DRUG GUTONG TIEGAO PAIN RELIEVING CAMPHOR AND MENTHOL PATCH TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part348 FOSHAN AQUA GEL BIOTECH CO LTD CAMPHOR (SYNTHETIC); MENTHOL 43.9; 18.8 mg/1; mg/1 N 20181231 69159-301_18d42550-d760-43af-8938-878f1a5eaf07 69159-301 HUMAN OTC DRUG GUTONG TIEGAO PAIN RELIEVING Camphor and Menthol PATCH TOPICAL 20160413 OTC MONOGRAPH NOT FINAL part348 FOSHAN AQUA GEL BIOTECH CO LTD CAMPHOR (SYNTHETIC); MENTHOL 248; 100 mg/1; mg/1 N 20181231 69159-910_5d53bb54-e7d7-724f-e053-2a91aa0a5618 69159-910 HUMAN OTC DRUG Ultimate Topical Pain Relief Patch CAPSAICIN and MENTHOL, UNSPECIFIED FORM PATCH TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part348 Foshan Aqua Gel Biotech Co.,Ltd. MENTHOL, UNSPECIFIED FORM; CAPSAICIN 5; .0375 g/100g; g/100g N 20181231 69159-920_5d539dfd-9d87-c162-e053-2991aa0a51c0 69159-920 HUMAN OTC DRUG Lidocaine Pain Relief Patch LIDOCAINE and MENTHOL, UNSPECIFIED FORM PATCH TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part348 Foshan Aqua Gel Biotech Co.,Ltd. MENTHOL, UNSPECIFIED FORM; LIDOCAINE 1; 4 g/100g; g/100g N 20181231 69160-002_cdcf67b8-1a1c-422d-94f6-0c1777edadc2 69160-002 HUMAN OTC DRUG Docusate Sodium docusate sodium TABLET ORAL 20150519 OTC MONOGRAPH NOT FINAL part334 Olds Softgels Inc. DOCUSATE SODIUM 100 mg/1 N 20181231 69160-003_3324cde5-69bf-1e89-e054-00144ff8d46c 69160-003 HUMAN OTC DRUG Docusate Sodium 250mg docusate sodium CAPSULE ORAL 20160518 OTC MONOGRAPH NOT FINAL part334 Olds Softgels Inc. DOCUSATE SODIUM 250 mg/1 N 20181231 69161-001_5c78055a-4dea-9365-e053-2a91aa0a0b33 69161-001 HUMAN OTC DRUG No Pain More Gain Menthol CREAM TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part348 Lugus Group LLC MENTHOL 10 mg/100mg N 20181231 69161-002_5c76d517-658f-8c03-e053-2a91aa0add06 69161-002 HUMAN OTC DRUG No Pain More Gain Menthol AEROSOL, FOAM TOPICAL 20140829 OTC MONOGRAPH NOT FINAL part348 Lugus Group LLC MENTHOL 5 mg/100mg N 20181231 69161-003_5c7810a6-cb60-108c-e053-2991aa0a1936 69161-003 HUMAN OTC DRUG No Pain More Gain Menthol SPRAY TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part348 LUGUS GROUP LLC MENTHOL .1 mg/100mg N 20181231 69161-005_5c76a909-0251-3136-e053-2a91aa0a9634 69161-005 HUMAN OTC DRUG No Pain More Gain Menthol AEROSOL, SPRAY TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part348 Lugus Group LLC MENTHOL 5 mg/100mg N 20181231 69161-006_5c7622b7-0606-2459-e053-2991aa0a3cff 69161-006 HUMAN OTC DRUG No Pain More Gain Menthol LIQUID TOPICAL 20171023 OTC MONOGRAPH NOT FINAL part348 Lugus Group LLC MENTHOL 10 mg/100mg N 20181231 69163-4131_8b24a2cb-c95f-411c-aeb7-6305b85e6ee7 69163-4131 HUMAN OTC DRUG ZymaDerm Iodine, Thuja Occidentalis Whole and Echinacea, Unspecified LIQUID TOPICAL 20130422 UNAPPROVED HOMEOPATHIC Naturopathix, Inc. IODINE; THUJA OCCIDENTALIS WHOLE; ECHINACEA, UNSPECIFIED 5; 5; 5 [hp_X]/13mL; [hp_C]/13mL; [hp_C]/13mL E 20171231 69163-4132_4a30769a-2610-4f56-b868-82f1d28e6916 69163-4132 HUMAN OTC DRUG ZymaDerm for Cold Sores Iodine, Cinnamomum Camphora Whole, Melissa Officinalis, Beta Vulgaris, Basil and Mentha Piperita LIQUID TOPICAL 20050615 UNAPPROVED HOMEOPATHIC Naturopathix, Inc. IODINE; CINNAMOMUM CAMPHORA WHOLE; MELISSA OFFICINALIS; BETA VULGARIS; BASIL; MENTHA PIPERITA 5; 5; 3; 4; 5; 3 [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL E 20171231 69163-4134_b39fa36e-b4d3-418e-9980-59746b711a67 69163-4134 HUMAN OTC DRUG ZymaDerm for Warts Iodine, Thuja Occidentalis Whole, Origanum Vulgare Subsp. Hirtum Whole, Myrtus Communis Whole, Cymbopogon Citratus Whole, and Pelargonium Graveolens Whole LIQUID TOPICAL 20050615 UNAPPROVED HOMEOPATHIC Naturopathix, Inc. IODINE; THUJA OCCIDENTALIS WHOLE; ORIGANUM VULGARE SUBSP. HIRTUM WHOLE; MYRTUS COMMUNIS WHOLE; CYMBOPOGON CITRATUS WHOLE; PELARGONIUM GRAVEOLENS WHOLE 5; 3; 3; 3; 5; 5 [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL E 20171231 69163-4135_fbfce570-c344-41a8-aa8a-70e0ee592435 69163-4135 HUMAN OTC DRUG ZymaDerm for Shingles Iodine, Pelargonium Graveolens Whole, Melissa Officinalis, Beta Vulgaris, Cymbopogon Citratus Whole and Mentha Piperita LIQUID TOPICAL 20050615 UNAPPROVED HOMEOPATHIC Naturopathix, Inc. IODINE; PELARGONIUM GRAVEOLENS WHOLE; MELISSA OFFICINALIS; BETA VULGARIS; CYMBOPOGON CITRATUS WHOLE; MENTHA PIPERITA 5; 5; 3; 4; 5; 3 [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL; [hp_X]/13mL E 20171231 69163-4136_7b5f0be3-e370-4596-bedd-51ea22b38ca1 69163-4136 HUMAN OTC DRUG ZymaDerm SILVER NITRATE, ECHINACEA ANGUSTIFOLIA, FUCUS VESICULOSUS and THUJA OCCIDENTALIS LEAFY TWIG LIQUID TOPICAL 20130422 UNAPPROVED HOMEOPATHIC Naturopathix, Inc. SILVER NITRATE; ECHINACEA ANGUSTIFOLIA; FUCUS VESICULOSUS; THUJA OCCIDENTALIS LEAFY TWIG 5; 7; 7; 7 [hp_X]/13mL; [hp_C]/13mL; [hp_X]/13mL; [hp_X]/13mL N 20181231 69164-1001_01030021-757c-446f-9833-564372485118 69164-1001 HUMAN OTC DRUG Colloidal Iodine GLYCERIN CREAM TOPICAL 20140827 OTC MONOGRAPH FINAL part347 JCI INSTITUTE OF MEDICAL SCIENCE GLYCERIN 1 g/100mL E 20171231 69164-1002_24d47429-a0b1-477b-b4a4-568de1aaa19c 69164-1002 HUMAN OTC DRUG JCI MN Colloidal Iodine Cream GLYCERIN CREAM TOPICAL 20150201 OTC MONOGRAPH FINAL part347 JCI INSTITUTE OF MEDICAL SCIENCE GLYCERIN 1 g/100mL E 20171231 69164-2001_99764a2f-83fc-4b5b-b71c-d606fda2b9fe 69164-2001 HUMAN OTC DRUG Colloidal Iodine IODINE SOLUTION TOPICAL 20140827 OTC MONOGRAPH NOT FINAL part333A JCI INSTITUTE OF MEDICAL SCIENCE IODINE 2 g/100mL E 20171231 69164-2002_cf0905de-6715-423a-8878-d06f83d73af6 69164-2002 HUMAN OTC DRUG JCI MN Colloidal Iodine Immune-improving Water IODINE SOLUTION TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part333A JCI INSTITUTE OF MEDICAL SCIENCE IODINE 2 g/100mL E 20171231 69164-2002_e2d538ad-ccd8-4545-b8d7-4c7531bfe12a 69164-2002 HUMAN OTC DRUG JCI MN Colloidal Iodine Immune-improving Water IODINE SOLUTION TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part333A JCI INSTITUTE OF MEDICAL SCIENCE IODINE 2 g/100mL E 20171231 69164-3001_b033986f-34ca-4918-91e3-2e928eea028b 69164-3001 HUMAN OTC DRUG Colloidal Iodine Ophthalmic IODINE SOLUTION TOPICAL 20140827 OTC MONOGRAPH NOT FINAL part333A JCI INSTITUTE OF MEDICAL SCIENCE IODINE .1 g/100mL E 20171231 69164-3002_761826cb-79f0-4ffc-b2eb-5e35c1e18ec3 69164-3002 HUMAN OTC DRUG JCI MN Colloidal Iodine Eye Wash Cleansing Water (Quasi Drug) IODINE SOLUTION TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part333A JCI INSTITUTE OF MEDICAL SCIENCE IODINE .1 g/100mL E 20171231 69164-4001_0dd7ace6-fbeb-6d19-e054-00144ff8d46c 69164-4001 HUMAN OTC DRUG JCI MN Colloidal Iodine Immune-improving Water IODINE SOLUTION TOPICAL 20150127 OTC MONOGRAPH NOT FINAL part333A JCI INSTITUTE OF MEDICAL SCIENCE IODINE 2 g/100mL E 20171231 69164-4002_e89e342e-4793-4911-a6ef-f627ce35df7b 69164-4002 HUMAN OTC DRUG JCI MN Colloidal Iodine Immune-improving Water IODINE SOLUTION TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part333A JCI INSTITUTE OF MEDICAL SCIENCE IODINE 2 g/100mL E 20171231 69165-101_95beb730-ec50-4fea-bd4b-146437b7092e 69165-101 HUMAN OTC DRUG PAIN CHLORPHENIRAMINE MALEATE, METHYL SALICYLATE, SCOPOLIA CARNIOLICA WHOLE, MENTHOL, PEPPERMINT, CAMPHOR (SYNTHETIC), PHELLODENDRON AMURENSE WHOLE PATCH TOPICAL 20140812 UNAPPROVED HOMEOPATHIC GEORGE L. RODRIGUEZ M.D., PC CHLORPHENIRAMINE MALEATE; METHYL SALICYLATE; SCOPOLIA CARNIOLICA WHOLE; MENTHOL; PEPPERMINT OIL; CAMPHOR (SYNTHETIC); PHELLODENDRON AMURENSE WHOLE 13.4; 26.9; 2.7; 26.9; 26.9; 13.4; 13.4 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 E 20171231 69165-201_f50769ca-2c0d-422d-91ea-1c37b5a64b4c 69165-201 HUMAN OTC DRUG ANTIPAIN-S RADIX CLEMATIDIS, SEMEN MOMORDICAE, MYRRHA, OLIBANUM, MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20140812 UNAPPROVED HOMEOPATHIC GEORGE L. RODRIGUEZ M.D., PC CLEMATIS HEXAPETALA WHOLE; MOMORDICA CHARANTIA WHOLE; MYRRH; FRANKINCENSE OIL; MENTHOL 30; 15; 20; 20; 50 mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 69166-105_43d8cf5e-2de5-49ac-8b5c-40b7a7c6171f 69166-105 HUMAN PRESCRIPTION DRUG Relador Pak with Occlusive Dressing lidocaine and prilocaine CREAM TOPICAL 20150425 ANDA ANDA076290 Accelis Pharma LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 69166-155_213b3e46-bea7-4ef3-b0fe-ceb9ce885f4e 69166-155 HUMAN PRESCRIPTION DRUG Relador Pak Plus lidocaine and prilocaine KIT TOPICAL 20150425 ANDA ANDA076290 Accelis Pharma E 20171231 69166-523_5b21dbc4-23fe-1d3b-e053-2a91aa0adfef 69166-523 HUMAN PRESCRIPTION DRUG OBREDON Hydrocodone Bitartrate and Guaifenesin SOLUTION ORAL 20141230 20180630 NDA NDA205474 NOVOTEC PHARMA LLC HYDROCODONE BITARTRATE; GUAIFENESIN 2.5; 200 mg/5mL; mg/5mL Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 69168-023_fc3d9754-8aa8-47cd-9a5a-13c1f7589294 69168-023 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen 80 mg TABLET ORAL 20150303 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN 80 mg/1 E 20171231 69168-029_6393feb4-c764-47a1-be4e-d3660943db27 69168-029 HUMAN OTC DRUG Tension Headache Relief Tension Headache Relief CAPSULE ORAL 20141126 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 69168-046_015ca07a-f6b5-4741-a7b0-821cf6d4e418 69168-046 HUMAN OTC DRUG Bismuth Bismuth subsalicylate TABLET ORAL 20141223 OTC MONOGRAPH FINAL part335 Allegiant Health BISMUTH SUBSALICYLATE 262 mg/1 E 20171231 69168-048_c2823bad-540f-4662-8dcc-58e9f0d94efb 69168-048 HUMAN OTC DRUG Allergy Diphenhydramine HCl TABLET ORAL 20141215 OTC MONOGRAPH FINAL part341 Allegiant Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 69168-076_aaa06798-ed92-49a9-a94a-f0103427fde3 69168-076 HUMAN OTC DRUG Stay Awake Caffeine TABLET, COATED ORAL 20140701 OTC MONOGRAPH FINAL part340 Allegiant Health CAFFEINE 200 mg/1 N 20181231 69168-219_b298b86b-193b-40e4-8065-630cd8ed19c9 69168-219 HUMAN OTC DRUG Calcium Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20141216 OTC MONOGRAPH FINAL part331 Allegiant Health CALCIUM CARBONATE 500 mg/1 N 20181231 69168-226_b5d0bdf6-d934-4d79-bc66-5c25c1bfe99c 69168-226 HUMAN OTC DRUG Laxative Bisacodyl TABLET ORAL 20141223 OTC MONOGRAPH NOT FINAL part334 Allegiant Health BISACODYL 5 mg/1 N 20181231 69168-229_9ae1102b-ac94-4fb2-8cf9-003e1c34bdb8 69168-229 HUMAN OTC DRUG Calcium Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20141216 OTC MONOGRAPH FINAL part331 Allegiant Health CALCIUM CARBONATE 750 mg/1 N 20181231 69168-232_860edd21-09bd-494f-a3bb-58fad750c9e5 69168-232 HUMAN OTC DRUG Bisacodyl 5mg Bisacodyl 5mg TABLET, COATED ORAL 20141223 OTC MONOGRAPH NOT FINAL part334 Allegiant Health BISACODYL 5 mg/1 N 20181231 69168-234_f316e210-83b7-4cf7-aad7-28215c7ce8d2 69168-234 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen 325 mg TABLET ORAL 20141216 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN 325 mg/1 N 20181231 69168-235_cd5e35b0-804d-4091-bac2-491b53f25c6d 69168-235 HUMAN OTC DRUG Pain ReliefExtra Strength Extra Strength Acetaminophen 500 mg TABLET ORAL 20141217 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN 500 mg/1 N 20181231 69168-235_de064623-31ad-4d37-8025-922d39624f27 69168-235 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen 500 mg TABLET ORAL 20141217 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN 500 mg/1 N 20181231 69168-243_b4b5341d-c1b2-4cbd-9c86-bee80283fc7a 69168-243 HUMAN OTC DRUG Anti Gas Extra Strength Simethicone CAPSULE, LIQUID FILLED ORAL 20141216 OTC MONOGRAPH FINAL part332 Allegiant Health DIMETHICONE 125 mg/1 E 20171231 69168-247_566e40b1-e9d7-44e4-b971-eef2b7cf0a7d 69168-247 HUMAN OTC DRUG Sleep Tabs For Nighttime use Diphenhydramine HCl Tablets TABLET ORAL 20150428 OTC MONOGRAPH FINAL part338 Allegiant Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 69168-248_075be768-af7e-4008-b377-ee8b302dc230 69168-248 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl TABLET, COATED ORAL 20050503 ANDA ANDA076497 Allegiant Health LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 69168-261_a1a8c1b0-1c3d-4d32-b505-e92a19623f65 69168-261 HUMAN OTC DRUG Acetaminophen Phenylephrine HCl Acetaminophen 500mg Phenylephrine HCl 5mg TABLET ORAL 20141201 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 500; 5 mg/1; mg/1 E 20171231 69168-263_63df6080-cd35-4b57-aacc-a5016e3270fc 69168-263 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl 25 mg TABLET ORAL 20150303 OTC MONOGRAPH FINAL part338 Allegiant Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69168-267_3ab653b6-f388-41b1-828c-9ed741a07b24 69168-267 HUMAN OTC DRUG Pain Relief PM Extra Strength Acetaminophen 500 mg and Diphenhydramine HCl 25 mg TABLET ORAL 20141223 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 69168-270_7d26163d-1b4c-4ffb-b122-8f925dc32b8f 69168-270 HUMAN OTC DRUG Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy Acetaminophen and Phenylephrine HCl TABLET ORAL 20141222 OTC MONOGRAPH FINAL part341 Allegiant Health ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 69168-272_7aef00df-816a-4ea2-a2ad-beed66dd2fe4 69168-272 HUMAN OTC DRUG Nasal Decongestant PE Maximum Strength Non-Drowsy Phenylephrine 10 mg TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 E 20171231 69168-277_4305ad50-d2a5-4d3e-9d92-cbf26e856a16 69168-277 HUMAN OTC DRUG Allergy Chlorpheniramine maleate TABLET ORAL 20141215 OTC MONOGRAPH FINAL part341 Allegiant Health CHLORPHENIRAMINE MALEATE 4 mg/1 E 20171231 69168-285_06c59d37-07c9-4591-97c8-65d869813c57 69168-285 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED ORAL 20100215 NDA NDA020802 Allegiant Health ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 69168-288_92b8637b-03a9-461f-b2f6-6eddaa214953 69168-288 HUMAN OTC DRUG Aspirin Chewable Aspirin 81 mg TABLET ORAL 20141218 OTC MONOGRAPH FINAL part343 Allegiant Health ASPIRIN 81 mg/1 E 20171231 69168-302_439b0113-2b2b-4369-b019-1437e5720f7c 69168-302 HUMAN OTC DRUG Cold and Allergy Phenylephrine HCl and Chlorpheniramine maleate TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE 10; 4 mg/1; mg/1 E 20171231 69168-309_0991388a-2eb8-4913-9efc-adf411eddf3a 69168-309 HUMAN OTC DRUG Allergy Relief Loratadine TABLET ORAL 20141216 ANDA ANDA076471 Allegiant Health LORATADINE 10 mg/1 E 20171231 69168-310_c0b578fb-8313-4478-b16a-d19f8ec20453 69168-310 HUMAN OTC DRUG Allergy Relief Cetirizine HCl 10 mg TABLET ORAL 20141216 ANDA ANDA078317 Allegiant Health CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 69168-312_95dd3181-8bc3-4e1c-a88c-36386b0adb67 69168-312 HUMAN OTC DRUG Aspirin Aspirin 325 mg TABLET ORAL 20141218 OTC MONOGRAPH FINAL part343 Allegiant Health ASPIRIN 325 mg/1 E 20171231 69168-314_418d81eb-933b-4457-ac20-603cc985d0f2 69168-314 HUMAN OTC DRUG Stool Softener Docusate Sodium 100 mg CAPSULE ORAL 20141223 OTC MONOGRAPH NOT FINAL part334 Allegiant Health DOCUSATE SODIUM 100 mg/1 N 20181231 69168-318_3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5 69168-318 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin 81 mg TABLET ORAL 20141218 OTC MONOGRAPH FINAL part343 Allegiant Health ASPIRIN 81 mg/1 E 20171231 69168-319_3f020cf2-6011-4216-9b39-0b3dc5f0749c 69168-319 HUMAN OTC DRUG Cold Multi-Symptom Night-time Acetaminophen,Chlorpheniramine maleate, Dextromethorphan HBr and Phenylephrine HCI TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 69168-323_38bedaf5-44be-4695-9c21-ef40a0a0c960 69168-323 HUMAN OTC DRUG Cold Multi-Symptom Day-time Acetaminophen,Guaifenesin, Dextromethorphan HBr and Phenylephrine HCI TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 10; 5 mg/1; mg/1; mg/1; mg/1 E 20171231 69168-324_ddd91ea8-54d2-4eb6-a874-ea040cf01728 69168-324 HUMAN OTC DRUG Cold Multi-Symptom Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl TABLET, COATED ORAL 20150815 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 69168-328_8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7 69168-328 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen 500 mg TABLET ORAL 20141217 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN 500 mg/1 N 20181231 69168-330_fea95b97-1037-423a-a548-6e852e8f62dd 69168-330 HUMAN OTC DRUG Mucus ReliefImmediate Release Immediate Release Guaifenesin TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health GUAIFENESIN 400 mg/1 N 20181231 69168-331_f4af1b4c-6818-4b73-afc8-8f6d79e4b052 69168-331 HUMAN OTC DRUG Aspirin Enteric Coated Aspirin 325 mg TABLET ORAL 20141218 OTC MONOGRAPH FINAL part343 Allegiant Health ASPIRIN 325 mg/1 E 20171231 69168-335_dd63b011-0573-4374-9669-8d29146e5fc9 69168-335 HUMAN OTC DRUG Ibuprofen Fast relief medicine for pain Ibuprofen 200 mg TABLET ORAL 20141219 ANDA ANDA079129 Allegiant Health IBUPROFEN 200 mg/1 N 20181231 69168-338_4c517518-6618-4ebe-a05a-3c668e2954a0 69168-338 HUMAN OTC DRUG Ibuprofen Pain reliever/fever reducer Ibuprofen 200 mg TABLET ORAL 20141222 ANDA ANDA091355 Allegiant Health IBUPROFEN 200 mg/1 N 20181231 69168-345_94373244-40e8-4c63-b61e-1bd32bd5442d 69168-345 HUMAN OTC DRUG Mucus Relief DMImmediate Release Immediate Release Dextromethorphan HBr and Guaifenesin TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 69168-346_3eab9688-5054-4280-b88c-fcf9de26a0d2 69168-346 HUMAN OTC DRUG Allergy Softgel Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20141215 OTC MONOGRAPH FINAL part341 Allegiant Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 69168-353_01d11093-e9d4-4786-91af-17060380d705 69168-353 HUMAN OTC DRUG Pain Relief Extra Strength Easy to Swallow Acetaminophen 500 mg TABLET ORAL 20141217 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN 500 mg/1 N 20181231 69168-353_0b89b13f-b2fc-4580-9317-b387286f1e81 69168-353 HUMAN OTC DRUG Pain Relief Easy to Swallow Extra Strength Easy to Swallow Acetaminophen 500 mg TABLET ORAL 20141217 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN 500 mg/1 N 20181231 69168-354_0b2a2dac-7e5c-411b-bedb-87141a11d93d 69168-354 HUMAN OTC DRUG Mucus Relief D Immediate Release Guaifenesin and Phenylephrine HCl TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 69168-356_791aff66-e50f-400b-b575-92e1d61caa74 69168-356 HUMAN OTC DRUG Day Time Cold and FlueNon drowsy Non drowsy Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCI 5 mg CAPSULE, LIQUID FILLED ORAL 20150303 OTC MONOGRAPH FINAL part341 Allegiant Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 69168-357_b54b14df-886e-438f-8b63-bbc5376fd653 69168-357 HUMAN OTC DRUG Night Time Cold and Flue Relief Acetaminophen, Dextromethorphan, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20150303 OTC MONOGRAPH FINAL part341 Allegiant Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 69168-361_1b97ae91-7304-49f3-a5aa-38973bb61c49 69168-361 HUMAN OTC DRUG Naproxen All day relief for pain Naproxen Sodium 220 mg TABLET ORAL 20141223 ANDA ANDA090545 Allegiant Health NAPROXEN SODIUM 220 mg/1 E 20171231 69168-362_0f1e4e8d-41fe-483f-9e80-7d3969bb891a 69168-362 HUMAN OTC DRUG Naproxen Caplets All day relief for pain Naproxen Sodium 220 mg TABLET ORAL 20141223 ANDA ANDA090545 Allegiant Health NAPROXEN SODIUM 220 mg/1 N 20181231 69168-363_bd0caf34-91ef-4dd4-9d03-a48385ffceea 69168-363 HUMAN OTC DRUG Ibuprofen Liqui-gels Ibuprofen 200 mg CAPSULE, LIQUID FILLED ORAL 20141222 ANDA ANDA079205 Allegiant Health IBUPROFEN 200 mg/1 N 20181231 69168-375_261328fe-a588-43d6-a8c7-817e2069204b 69168-375 HUMAN OTC DRUG Ranitidine 150 Ranitidine Hydrochloride Tablets 150mg TABLET, COATED ORAL 20100105 ANDA ANDA078192 Allegiant Health RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 69168-376_fff1cd47-bde5-40a3-bffa-bc099959f093 69168-376 HUMAN OTC DRUG Acid Reducer 75 Ranitidine 75mg TABLET, COATED ORAL 20140701 ANDA ANDA076760 Allegiant Health RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 69168-380_326c9c41-6e57-4371-b9e5-d68f8eec731e 69168-380 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20170517 ANDA ANDA208150 Allegiant Health FLUTICASONE PROPIONATE 50 ug/1 N 20181231 69168-543_710f9521-4b37-4004-a160-6b4c9ad2346d 69168-543 HUMAN OTC DRUG Mucus Relief DM Immediate Release Dextromethorphan HBr and Guaifenesin TABLET ORAL 20141223 OTC MONOGRAPH FINAL part341 Allegiant Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 69168-632_c3888bf1-7770-400e-a899-45e42a186656 69168-632 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium 220mg TABLET, COATED ORAL 20141223 ANDA ANDA090545 Allegiant Health NAPROXEN SODIUM 220 mg/1 N 20181231 69168-762_1967be99-004d-43ae-ba6d-8b8815a30592 69168-762 HUMAN OTC DRUG Sound Body Pain Relief PM Acetaminophen 500 mg and Diphenhydramine HCl 25 mg TABLET, COATED ORAL 20141223 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 69168-902_99f1fdfe-5e63-4e20-aab8-63d8d420ef58 69168-902 HUMAN OTC DRUG Ranitidine 150 Ranitidine HCl Tablets 150mg TABLET, COATED ORAL 20100105 ANDA ANDA078192 Allegiant Health RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 69168-904_8e618fe0-e7e5-4439-b03b-761a0b52542c 69168-904 HUMAN OTC DRUG Anti-Gas Simethicone CAPSULE, LIQUID FILLED ORAL 20141216 OTC MONOGRAPH FINAL part332 Allegiant Health DIMETHICONE 125 mg/1 N 20181231 69168-910_6b4a3473-cd20-4f4e-a3e7-ce82aa85c55c 69168-910 HUMAN OTC DRUG Sound Body Sleep Aid Diphenhydramine HCl 25 mg TABLET, COATED ORAL 20150303 OTC MONOGRAPH FINAL part338 Allegiant Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69168-913_5406ecf4-5567-4b54-9cc8-208dcae6fa98 69168-913 HUMAN OTC DRUG Sound Body Extra Strength Pain Reliever Acetaminophen 500 mg TABLET ORAL 20141217 OTC MONOGRAPH NOT FINAL part343 Allegiant Health ACETAMINOPHEN 500 mg/1 N 20181231 69168-914_6b98c3d1-8118-4dcb-9717-b5572949a5b5 69168-914 HUMAN OTC DRUG Sound Body Ibuprofen Ibuprofen 200 mg CAPSULE, LIQUID FILLED ORAL 20141222 ANDA ANDA079205 Allegiant Health IBUPROFEN 200 mg/1 N 20181231 69170-102_e1b40b9c-e70b-410f-ab5c-3118425d041e 69170-102 HUMAN OTC DRUG LICE ICE NEEM OIL, TEA TREE OIL GEL TOPICAL 20140815 UNAPPROVED HOMEOPATHIC NATURALRX LLC AZADIRACHTA INDICA SEED OIL; TEA TREE OIL .937; .937 [hp_X]/100mL; [hp_X]/100mL E 20171231 69170-103_82c15dca-a4b4-4102-b352-bb78415cf1ab 69170-103 HUMAN OTC DRUG LICE ICE COLOR-FREE NEEM, TEA TREE GEL TOPICAL 20140815 UNAPPROVED HOMEOPATHIC NATURALRX LLC AZADIRACHTA INDICA SEED OIL; TEA TREE OIL .937; .937 [hp_X]/100mL; [hp_X]/100mL E 20171231 69170-104_2e57a3ff-2fff-4d09-8885-18d7cfc6db2f 69170-104 HUMAN OTC DRUG MUSCLE AND JOINT RELIEF EMU CREAM TOPICAL 20151101 UNAPPROVED HOMEOPATHIC NATURALRX LLC EMU OIL 1 [hp_X]/100mL E 20171231 69171-398_2be9f49d-e7c2-4846-e054-00144ff8d46c 69171-398 HUMAN PRESCRIPTION DRUG Onivyde Irinotecan hydrochloride INJECTION INTRAVENOUS 20151022 NDA NDA207793 Merrimack Pharmaceuticals IRINOTECAN HYDROCHLORIDE 4.3 mg/mL Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] E 20171231 69173-0001_8059c5e6-0d01-46d0-a2ed-2eea7509b36f 69173-0001 HUMAN OTC DRUG Iron Therapy Chininum Arsenicosum, Cuprum Sulphuricum, Ferrum Metallicum, Ferrum Phosphoricum, Zincum Metallicum TABLET ORAL 20150223 UNAPPROVED HOMEOPATHIC Nutrexin USA QUININE ARSENATE; CUPRIC SULFATE; IRON; FERROSOFERRIC PHOSPHATE; ZINC 12; 6; 8; 8; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69174-125_cc2a6f91-531c-4d6c-9886-8166709070a3 69174-125 HUMAN OTC DRUG Tenzer Baby PETROLATUM JELLY TOPICAL 20120530 OTC MONOGRAPH FINAL part347 Collection 2000 PETROLATUM 99.7 g/100g E 20171231 69174-126_685fa740-cc03-4508-b5a7-6a097d82597d 69174-126 HUMAN OTC DRUG Tenzer Baby PETROLATUM JELLY TOPICAL 20120530 OTC MONOGRAPH FINAL part347 Collection 2000 Cosmetics,Inc. PETROLATUM 100 g/100g E 20171231 69176-010_1dab5315-5028-57ad-e054-00144ff8d46c 69176-010 HUMAN PRESCRIPTION DRUG Inflammation Reduction Pack Inflammation Reduction Pack KIT 20150818 ANDA ANDA074514 TMIG, Inc. N 20181231 69176-010_48f7c15c-0a00-411b-b3c2-3e57f0b6d49a 69176-010 HUMAN PRESCRIPTION DRUG Inflammation Reduction Pack Inflammation Reduction Pack KIT 20150818 ANDA ANDA074514 TMIG, Inc. N 20181231 69176-010_dad58da4-25d4-40ec-b325-2458bc8de1ef 69176-010 HUMAN PRESCRIPTION DRUG Inflammation Reduction Pack Inflammation Reduction Pack KIT 20150818 ANDA ANDA074514 TMIG, Inc. N 20181231 69176-011_1eb20ef6-7a57-5b3e-e054-00144ff88e88 69176-011 HUMAN PRESCRIPTION DRUG Omega-3 Well Pack Omega-3 Well Pack KIT ORAL 20150901 ANDA ANDA090973 TMIG, Inc. N 20181231 69176-025_0fb9595b-edd5-458d-bec4-07ac956c72cd 69176-025 HUMAN PRESCRIPTION DRUG Renovo Menthol and Capsaicin PATCH TOPICAL 20140925 UNAPPROVED DRUG OTHER TMIG, Inc. MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g E 20171231 69176-035_874a535a-03c0-41de-a21b-39222f0a4e61 69176-035 HUMAN PRESCRIPTION DRUG Toxicology Saliva Collection Kit Toxicology Saliva Collection Kit KIT ORAL 20150130 ANDA ANDA075682 TMIG, Inc. E 20171231 69176-070_32901f07-0372-1b66-e054-00144ff88e88 69176-070 HUMAN PRESCRIPTION DRUG Rapid Gel Rx ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM, ZINGIBER OFFICINALE GEL TRANSDERMAL 20160420 UNAPPROVED HOMEOPATHIC TMIG Inc ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE; GINGER 1; 1; 3; 1; 1; 1; 3; 1; 1; 1; 1; 3; 3; 1 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] E 20171231 69176-100_35dc3f7b-43d6-6203-e054-00144ff88e88 69176-100 HUMAN PRESCRIPTION DRUG Cyclo/Gaba 10/300 Pack Cyclo/Gaba 10/300 Pack KIT ORAL 20110129 ANDA ANDA090858 TMIG Inc. N 20181231 69176-140_45af4ad7-0984-00ca-e054-00144ff88e88 69176-140 HUMAN PRESCRIPTION DRUG Lido-Prilo Caine Pack lidocaine and prilocaine KIT 20170109 NDA AUTHORIZED GENERIC NDA019941 TMIG Inc. N 20181231 69176-150_4601eb5e-8699-55c9-e054-00144ff88e88 69176-150 HUMAN PRESCRIPTION DRUG Migraine Pack Sumatriptan Succinate, MENTHOLUM, BELLADONNA, IRIS VERSICOLOR, SANGUINARIA CANADENSIS KIT 20170113 ANDA ANDA078327 TMIG Inc N 20181231 69176-200_3566f528-4193-5a33-e054-00144ff8d46c 69176-200 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110129 ANDA ANDA090858 TMIG Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69176-300_352f7cf7-c592-364b-e054-00144ff88e88 69176-300 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 19890503 ANDA ANDA071611 TMIG Inc CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 69180-001_6a9ef5a6-7a34-4fcc-9bc5-c3f82b85ebb1 69180-001 HUMAN OTC DRUG True Pain Relief Plus Methyl Salicylate, Menthol, Capsaicin LOTION TOPICAL 20030301 OTC MONOGRAPH NOT FINAL part348 Nature City, LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN 100; 12.5; .25 mg/g; mg/g; mg/g N 20181231 69180-001_c2fbd4df-c1e2-4b0d-be07-ed9d9c43184e 69180-001 HUMAN OTC DRUG True Pain Relief Plus Methyl Salicylate, Menthol, Capsaicin LOTION TOPICAL 20030301 OTC MONOGRAPH NOT FINAL part348 Nature City, LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN 100; 12.5; .25 mg/g; mg/g; mg/g N 20181231 69181-158_005dd5ee-80ee-4e89-9c63-96e8d57b503a 69181-158 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150204 ANDA ANDA075576 Midwest Drug Distribution, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69183-200_04449282-8d9e-4052-bd21-16d752e2b338 69183-200 HUMAN OTC DRUG Eyes Alive Lubricating CARBOXYMETHYLCELLULOSE SODIUM LIQUID INTRAOCULAR 20150201 OTC MONOGRAPH FINAL part349 DIVISION 5 LABS, INC. CARBOXYMETHYLCELLULOSE SODIUM 5 mg/mL E 20171231 69183-230_41e206d3-8e05-4758-a31c-757688a81377 69183-230 HUMAN OTC DRUG Eyes Alive Eye Wash Water SOLUTION OPHTHALMIC 20170201 OTC MONOGRAPH FINAL part349 DIVISION 5 LABS, INC. WATER 980 mg/mL N 20181231 69184-001_7fea3489-7ded-4ca2-a4c7-3e00aa0b2153 69184-001 HUMAN OTC DRUG Super BB All-In-1 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20140917 OTC MONOGRAPH FINAL part352 Mei Shual Cosmetics Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 15; 10 mg/100mg; 1/100mg N 20181231 69184-002_59525604-c133-4e46-9173-c74a40c26ef9 69184-002 HUMAN OTC DRUG Mineral Wear titanium dioxide, zinc oxide POWDER TOPICAL 20141208 OTC MONOGRAPH FINAL part352 Mei Shual Cosmetics Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 6; 4.2 g/100g; g/100g N 20181231 69186-001_ba32c96a-bd18-4b8c-bca8-c31aad906f5a 69186-001 HUMAN OTC DRUG Actiogen Acne Dots Treatment Acne Treatment PATCH TOPICAL 20140801 OTC MONOGRAPH FINAL part333D Actiogen Corp SALICYLIC ACID 2 mg/100mg N 20181231 69189-0007_be583ea6-29b4-4973-aa0e-d7f5aa961983 69189-0007 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20150421 ANDA ANDA078181 Avera McKennan Hospital GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 69189-0008_928d2670-cd07-47a6-aaea-1926d1de0a5e 69189-0008 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20150301 NDA NDA021282 Avera McKennan Hospital GUAIFENESIN 600 mg/1 E 20171231 69189-0011_49985813-3428-412f-b01a-73f6c1ad3417 69189-0011 HUMAN PRESCRIPTION DRUG Flecainide Acetate flecainide acetate TABLET ORAL 20150301 ANDA ANDA076278 Avera McKennan Hospital FLECAINIDE ACETATE 100 mg/1 Antiarrhythmic [EPC] E 20171231 69189-0014_709d4413-11ba-4048-844c-ae03e240133d 69189-0014 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20150807 ANDA ANDA200294 Avera McKennan Hospital MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 69189-0020_ed269b30-0a24-4b18-a0be-41793c21d6d7 69189-0020 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20150527 ANDA ANDA076691 Avera McKennan Hospital LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] E 20171231 69189-0021_1c88dfda-46af-4cfb-962d-d2f71499c96a 69189-0021 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20150309 ANDA ANDA090778 Avera McKennan Hospital DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 69189-0022_744e4026-6b90-491e-969b-9cf40b2602f0 69189-0022 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20150302 ANDA ANDA090778 Avera McKennan Hospital DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 69189-0023_a194f5e4-e6f9-4987-a3a4-9df53ffe1caa 69189-0023 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20150416 ANDA ANDA076832 Avera McKennan Hospital LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] E 20171231 69189-0025_98ee10f3-d081-4e03-9350-df87c5a8ab7d 69189-0025 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20150309 ANDA ANDA200295 Avera McKennan Hospital LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 69189-0026_5de2bed9-e937-496a-8419-a43bcc14a92d 69189-0026 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20150401 ANDA ANDA200295 Avera McKennan Hospital LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 69189-0027_f0f7cd53-2d10-4b20-aaaf-1525b7937c26 69189-0027 HUMAN PRESCRIPTION DRUG omega-3-acid ethyl esters omega-3-acid ethyl esters CAPSULE, LIQUID FILLED ORAL 20150428 ANDA ANDA091018 Avera McKennan Hospital OMEGA-3-ACID ETHYL ESTERS 900 mg/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] E 20171231 69189-0035_9799ef9a-4f78-472a-913f-8450ebbaae85 69189-0035 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET ORAL 20150301 ANDA ANDA090568 Avera McKennan Hospital ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] E 20171231 69189-0046_f5f67d70-85f8-428c-8589-7737db6f2ea2 69189-0046 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20150304 ANDA ANDA090554 Avera McKennan Hospital DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 69189-0054_09d568a6-e1d6-4e03-9b5e-4d19585c276f 69189-0054 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET ORAL 20150302 ANDA ANDA088292 Avera McKennan Hospital IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69189-0055_cc6e656b-1a43-4fb7-b6ab-dabf90def208 69189-0055 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20151202 ANDA ANDA078155 Avera McKennan Hospital SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 69189-0058_93a13355-a9c4-4cde-a474-8a2bbfd775a2 69189-0058 HUMAN PRESCRIPTION DRUG Hydroxychloroquine Sulfate Hydroxychloroquine Sulfate TABLET ORAL 20150324 NDA AUTHORIZED GENERIC NDA009768 Avera McKennan Hospital HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] E 20171231 69189-0063_0ecb4ca6-ccf8-4945-ac60-88acc36d8003 69189-0063 HUMAN PRESCRIPTION DRUG TARCEVA erlotinib hydrochloride TABLET ORAL 20150401 NDA NDA021743 Avera McKennan Hospital ERLOTINIB HYDROCHLORIDE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] E 20171231 69189-0074_7605dd04-bf91-4b5b-a1f7-72d749a8ef63 69189-0074 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20150513 ANDA ANDA076410 Avera McKennan Hospital ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 69189-0075_5eb92b0f-acef-495a-a14a-11bb23d4106a 69189-0075 HUMAN PRESCRIPTION DRUG Hydrocortisone hydrocortisone TABLET ORAL 20150323 NDA AUTHORIZED GENERIC NDA008697 Avera McKennan Hospital HYDROCORTISONE 20 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69189-0076_83ce474c-0f9c-4aa0-bce5-1e00d168c458 69189-0076 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20150615 ANDA ANDA076410 Avera McKennan Hospital ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 69189-0078_da0d71c6-bd86-43fd-a6ba-c9ad12b27bd2 69189-0078 HUMAN PRESCRIPTION DRUG MENEST esterified estrogens TABLET, FILM COATED ORAL 20151123 ANDA ANDA084948 Avera McKennan Hospital ESTROGENS, ESTERIFIED .625 mg/1 N 20181231 69189-0083_fcdfa60e-18dd-424f-b8b1-f8ee4436ed66 69189-0083 HUMAN PRESCRIPTION DRUG Dificid fidaxomicin TABLET, FILM COATED ORAL 20150417 NDA NDA201699 Avera McKennan Hospital FIDAXOMICIN 200 mg/1 Macrolides [Chemical/Ingredient],Macrolide Antibacterial [EPC] N 20181231 69189-0086_da6198f2-384a-42ef-b32b-9a6a9ae4bcf0 69189-0086 HUMAN PRESCRIPTION DRUG Amitiza lubiprostone CAPSULE, GELATIN COATED ORAL 20150406 NDA NDA021908 Avera McKennan Hospital LUBIPROSTONE 8 ug/1 Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] E 20171231 69189-0088_20af8f2f-bd2a-4df1-ac95-54c73ec9348f 69189-0088 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20150309 ANDA ANDA077728 Avera McKennan Hospital CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 69189-0090_16baaf63-5088-4c3f-b6e5-c3459cb1108b 69189-0090 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20150301 ANDA ANDA090121 Avera McKennan Hospital FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 69189-0097_f346895f-ca6c-427f-b600-8781211a7189 69189-0097 HUMAN PRESCRIPTION DRUG Hydroxychloroquine sulfate Hydroxychloroquine sulfate TABLET, FILM COATED ORAL 20150831 ANDA ANDA040657 Avera McKennan Hospital HYDROXYCHLOROQUINE SULFATE 200 mg/1 Antirheumatic Agent [EPC],Antimalarial [EPC] E 20171231 69189-0102_d5f996be-d442-44cd-937f-a41fc5b3d98e 69189-0102 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20150313 ANDA ANDA077253 Avera McKennan Hospital FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] E 20171231 69189-0104_af29d851-c50e-4f39-896d-cb956311346d 69189-0104 HUMAN PRESCRIPTION DRUG Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate TABLET ORAL 20150311 UNAPPROVED DRUG OTHER Avera McKennan Hospital SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 852; 155; 130 mg/1; mg/1; mg/1 E 20171231 69189-0110_08f42745-9029-402f-8ecf-4f4a3f1b363c 69189-0110 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20150507 ANDA ANDA040746 Avera McKennan Hospital HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 69189-0112_62bbc10a-c2f0-4a90-b039-7456a3a892c9 69189-0112 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin TABLET, FILM COATED ORAL 20150301 ANDA ANDA061621 Avera McKennan Hospital ERYTHROMYCIN 250 mg/1 Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 69189-0116_ae5ce580-82e7-468a-8db8-35b536c1187b 69189-0116 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Extended-Release Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150629 ANDA ANDA078148 Avera McKennan Hospital ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 69189-0117_071606c8-2914-4b26-a0d2-74a4137b6ab0 69189-0117 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Extended-Release Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160427 ANDA ANDA078148 Avera McKennan Hospital ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 69189-0118_9d2d1c24-c03d-44a4-a389-f5c120757280 69189-0118 HUMAN PRESCRIPTION DRUG Atripla efavirenz, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20150306 NDA NDA021937 Avera McKennan Hospital EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600; 200; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 69189-0119_514a05fb-8be5-4db0-9545-6fe677aa391e 69189-0119 HUMAN PRESCRIPTION DRUG Colcrys Colchicine TABLET, FILM COATED ORAL 20150805 NDA NDA022352 Avera McKennan Hospital COLCHICINE .6 mg/1 Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA] E 20171231 69189-0132_d81e85e8-0281-45f3-a4e8-4f7277c67879 69189-0132 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20150305 ANDA ANDA040627 Avera McKennan Hospital BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 69189-0133_638310b2-3b9a-4ddc-a1ee-761af0ef61ac 69189-0133 HUMAN PRESCRIPTION DRUG Renvela SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20150301 NDA NDA022127 Avera McKennan Hospital SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] E 20171231 69189-0137_8f51e054-c331-4ec0-9608-d12219e17c85 69189-0137 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20150930 NDA NDA021977 Avera McKennan Hospital LISDEXAMFETAMINE DIMESYLATE 70 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 69189-0147_d0be21f9-71b9-41f8-854c-8cf48a6cff89 69189-0147 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20150301 ANDA ANDA076048 Avera McKennan Hospital OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 69189-0151_038ddf91-73f8-453b-9971-f9d389972632 69189-0151 HUMAN PRESCRIPTION DRUG Chlorothiazide chlorothiazide TABLET ORAL 20150301 ANDA ANDA084217 Avera McKennan Hospital CHLOROTHIAZIDE 250 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 69189-0160_88cdd341-0fe1-45b6-aff0-e974cfd72d0a 69189-0160 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20150817 ANDA ANDA091630 Avera McKennan Hospital TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 E 20171231 69189-0161_8d27861b-f767-4d46-9472-623919e456b4 69189-0161 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20150406 ANDA ANDA091667 Avera McKennan Hospital MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] E 20171231 69189-0164_53ca4d20-4f8b-48f5-878b-155b98b02086 69189-0164 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil CAPSULE ORAL 20150301 ANDA ANDA065410 Avera McKennan Hospital MYCOPHENOLATE MOFETIL 250 mg/1 Antimetabolite Immunosuppressant [EPC] E 20171231 69189-0168_4c4eb70d-78d7-4d6c-bd36-9363d82e9dc8 69189-0168 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20150323 ANDA ANDA077310 Avera McKennan Hospital CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] E 20171231 69189-0169_e513ac0a-443c-4b0b-a180-5603b7bd4a01 69189-0169 HUMAN PRESCRIPTION DRUG RAPAFLO silodosin CAPSULE ORAL 20150323 NDA NDA022206 Avera McKennan Hospital SILODOSIN 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 69189-0174_fe8ce389-582f-4880-849e-27cf985c40de 69189-0174 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20150323 ANDA ANDA075280 Avera McKennan Hospital NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 69189-0176_82ef2468-ca08-4121-8833-b6d8aa290d5b 69189-0176 HUMAN PRESCRIPTION DRUG Vyvanse lisdexamfetamine dimesylate CAPSULE ORAL 20150326 NDA NDA021977 Avera McKennan Hospital LISDEXAMFETAMINE DIMESYLATE 10 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 69189-0177_4a327497-b06b-4e8a-9f7e-a5e58245d723 69189-0177 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20150331 ANDA ANDA090931 Avera McKennan Hospital TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 69189-0178_4a80604b-c3e6-4dab-8faa-85c78a5aee7a 69189-0178 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20150527 ANDA ANDA078596 Avera McKennan Hospital METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 69189-0182_3efe198b-2f0e-4b63-94d6-70a3ca2031ce 69189-0182 HUMAN OTC DRUG Sodium Bicarbonate sodium bicarbonate TABLET, ORALLY DISINTEGRATING ORAL 20150305 OTC MONOGRAPH FINAL part331 Avera McKennan Hospital SODIUM BICARBONATE 650 mg/1 E 20171231 69189-0187_4da37b72-b727-4e44-8a33-db636a3245b8 69189-0187 HUMAN PRESCRIPTION DRUG Doxercalciferol doxercalciferol CAPSULE, LIQUID FILLED ORAL 20150406 NDA AUTHORIZED GENERIC NDA020862 Avera McKennan Hospital DOXERCALCIFEROL 2.5 ug/1 Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] E 20171231 69189-0188_f1d1fdd0-3fd0-46d0-8565-9347c27d7ec4 69189-0188 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET, CHEWABLE ORAL 20150416 ANDA ANDA076420 Avera McKennan Hospital LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 69189-0189_6618dfe2-5b3c-4357-a0bf-b58901cd367b 69189-0189 HUMAN PRESCRIPTION DRUG Pentasa mesalamine CAPSULE ORAL 20150427 NDA NDA020049 Avera McKennan Hospital MESALAMINE 250 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 69189-0190_743c4aa5-e3a1-459d-9181-8e55583c1d2f 69189-0190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20150406 ANDA ANDA075927 Avera McKennan Hospital NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69189-0194_71652150-70e6-4bb4-b0fc-a180fc8b8bcc 69189-0194 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20151202 ANDA ANDA090510 Avera McKennan Hospital HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 69189-0197_feb02ccd-f1a6-432e-8bc5-959c8be2e237 69189-0197 HUMAN OTC DRUG JUNIOR STRENGTH ADVIL ibuprofen TABLET, CHEWABLE ORAL 20150422 NDA NDA020944 Avera McKennan Hospital IBUPROFEN 100 mg/1 E 20171231 69189-0201_2ebfe777-4446-4380-8591-f502dfe7c6d0 69189-0201 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20150309 ANDA ANDA090083 Avera McKennan Hospital LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 69189-0203_c1fe743b-52fb-4b8c-822d-d599f2ca4638 69189-0203 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20150301 ANDA ANDA090083 Avera McKennan Hospital LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 69189-0204_aee4c7c7-0ee3-4c75-a99e-2d3792ba3d60 69189-0204 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20151104 ANDA ANDA078458 Avera McKennan Hospital METHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 69189-0210_5d17edf0-8400-49a9-a207-c1f299840107 69189-0210 HUMAN PRESCRIPTION DRUG LEXIVA fosamprenavir calcium TABLET, FILM COATED ORAL 20150330 NDA NDA021548 Avera McKennan Hospital FOSAMPRENAVIR CALCIUM 700 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],P-Glycoprotein Inducers [MoA] N 20181231 69189-0211_58c0f0cf-4f22-456a-9c96-973019cf4fc4 69189-0211 HUMAN PRESCRIPTION DRUG Midodrine Hydrochloride midodrine hydrochloride TABLET ORAL 20150301 ANDA ANDA076725 Avera McKennan Hospital MIDODRINE HYDROCHLORIDE 2.5 mg/1 Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] E 20171231 69189-0215_7a82e5ae-7d69-4852-9e20-4b89bf8870ea 69189-0215 HUMAN PRESCRIPTION DRUG RAPAFLO silodosin CAPSULE ORAL 20150501 NDA NDA022206 Avera McKennan Hospital SILODOSIN 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 69189-0223_dc3ebcba-7ee4-401a-ac61-2c0e888ee104 69189-0223 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20150401 ANDA ANDA077021 Avera McKennan Hospital CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] E 20171231 69189-0226_ed4b3623-d24c-4067-b0b8-46a8d4f748cb 69189-0226 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20150302 ANDA ANDA090858 Avera McKennan Hospital GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 69189-0227_79eac456-53ab-44ca-a7ab-65c0f40e66f0 69189-0227 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20150403 NDA NDA022145 Avera McKennan Hospital RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] N 20181231 69189-0239_1876c6c8-9613-4a77-b73b-9ad3c646ce54 69189-0239 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20150305 ANDA ANDA077955 Avera McKennan Hospital AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 69189-0242_9461c993-f972-4bbb-882b-904034f10236 69189-0242 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150401 NDA NDA022030 Avera McKennan Hospital FESOTERODINE FUMARATE 4 mg/1 E 20171231 69189-0243_1a109930-2b98-4b0e-a850-5c453065ec3a 69189-0243 HUMAN PRESCRIPTION DRUG Alinia nitazoxanide TABLET ORAL 20150526 NDA NDA021497 Avera McKennan Hospital NITAZOXANIDE 500 mg/1 Antiprotozoal [EPC] N 20181231 69189-0244_bc03a590-7608-4e1e-a407-2c55bed5814c 69189-0244 HUMAN PRESCRIPTION DRUG Toviaz fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150610 NDA NDA022030 Avera McKennan Hospital FESOTERODINE FUMARATE 8 mg/1 N 20181231 69189-0247_f12a430d-210b-48de-a482-508ebe3d0a26 69189-0247 HUMAN PRESCRIPTION DRUG Aricept donepezil hydrochloride TABLET, FILM COATED ORAL 20150323 NDA NDA022568 Avera McKennan Hospital DONEPEZIL HYDROCHLORIDE 23 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 69189-0252_97491ceb-a454-4419-ac85-1bd29d4c5a7f 69189-0252 HUMAN PRESCRIPTION DRUG Fosrenol lanthanum carbonate TABLET, CHEWABLE ORAL 20150303 NDA NDA021468 Avera McKennan Hospital LANTHANUM CARBONATE 500 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 69189-0259_c76c0c15-f202-4d88-9367-ab550fbf13be 69189-0259 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20150602 ANDA ANDA077634 Avera McKennan Hospital ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 69189-0262_42ae0c25-441f-4c50-baa0-cae9b4c7264f 69189-0262 HUMAN OTC DRUG Colace Clear Docusate sodium CAPSULE, LIQUID FILLED ORAL 20150616 OTC MONOGRAPH NOT FINAL part334 Avera McKennan Hospital DOCUSATE SODIUM 50 mg/1 E 20171231 69189-0263_a459e9b1-a93c-43b0-9e3a-34d494f44d94 69189-0263 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20150703 ANDA ANDA090655 Avera McKennan Hospital MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] E 20171231 69189-0267_d42c679c-d76f-4cb1-a95e-8f6c8f847b2e 69189-0267 HUMAN PRESCRIPTION DRUG Flucytosine Flucytosine CAPSULE ORAL 20150301 ANDA ANDA201566 Avera McKennan Hospital FLUCYTOSINE 250 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antifungal [EPC] E 20171231 69189-0270_8fecd1f1-c480-47d1-830f-b086951e3c79 69189-0270 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20150311 ANDA ANDA078110 Avera McKennan Hospital ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 69189-0276_6fb674e4-d978-42ed-be25-9a902a182331 69189-0276 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20150706 ANDA ANDA076899 Avera McKennan Hospital SULFAMETHOXAZOLE; TRIMETHOPRIM 400; 80 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 69189-0278_7287aaff-84b4-4222-8515-ec49275385f1 69189-0278 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20150311 ANDA ANDA078457 Avera McKennan Hospital QUINAPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69189-0280_15d042fc-8846-461b-a90d-792432f5e830 69189-0280 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20150323 ANDA ANDA078110 Avera McKennan Hospital ROPINIROLE HYDROCHLORIDE 3 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 69189-0281_d3aedc51-379d-4311-91cf-d4cb033ea6fc 69189-0281 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20150410 ANDA ANDA076899 Avera McKennan Hospital SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 69189-0288_f763d440-95c4-4dd2-b430-2aec5b92cd22 69189-0288 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20150605 ANDA ANDA078110 Avera McKennan Hospital ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] E 20171231 69189-0298_663953e5-72a2-4994-991f-5f0247c208f5 69189-0298 HUMAN PRESCRIPTION DRUG Bicalutamide Bicalutamide TABLET, FILM COATED ORAL 20150301 ANDA ANDA076932 Avera McKennan Hospital BICALUTAMIDE 50 mg/1 Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC] E 20171231 69189-0299_6f66be0c-3c8c-46b6-b4c3-a284782fe81c 69189-0299 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20150804 ANDA ANDA078250 Avera McKennan Hospital NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69189-0300_6ea81910-bd96-4ae0-a55c-322e15b22f47 69189-0300 HUMAN PRESCRIPTION DRUG Theo-24 theophylline anhydrous CAPSULE, EXTENDED RELEASE ORAL 20150324 ANDA ANDA087944 Avera McKennan Hospital THEOPHYLLINE ANHYDROUS 300 mg/1 Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 69189-0302_ca4fa7f3-4ca2-4dd6-a631-f081690cec46 69189-0302 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20150304 ANDA ANDA088487 Avera McKennan Hospital HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 69189-0304_6d9e8edb-f533-4a44-8131-58a0736ed415 69189-0304 HUMAN PRESCRIPTION DRUG Alfuzosin Hydrochloride extended release Alfuzosin Hydrochloride TABLET ORAL 20160323 ANDA ANDA090284 Avera McKennan Hospital ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 69189-0305_07882184-17bc-4025-8c2e-e7094696f08e 69189-0305 HUMAN PRESCRIPTION DRUG Norethindrone Acetate Norethindrone Acetate TABLET ORAL 20150406 ANDA ANDA091090 Avera McKennan Hospital NORETHINDRONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 69189-0307_9d8748d9-bf02-42ed-9c41-d9ae1d0157c0 69189-0307 HUMAN PRESCRIPTION DRUG hyoscyamine sulfate hyoscyamine sulfate TABLET, ORALLY DISINTEGRATING ORAL 20150304 UNAPPROVED DRUG OTHER Avera McKennan Hospital HYOSCYAMINE SULFATE .125 mg/1 E 20171231 69189-0309_36bc6a96-544d-4b0b-937d-323e308da080 69189-0309 HUMAN PRESCRIPTION DRUG XIFAXAN rifaximin TABLET ORAL 20150507 NDA NDA021361 Avera McKennan Hospital RIFAXIMIN 200 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 69189-0310_89907d25-3488-4994-bcb5-35220d549e80 69189-0310 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride TABLET, EXTENDED RELEASE ORAL 20150306 ANDA ANDA091695 Avera McKennan Hospital METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 69189-0314_7419e530-e9b9-44ca-b5e7-01a35491668d 69189-0314 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20150427 ANDA ANDA074754 Avera McKennan Hospital KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 69189-0317_20400d75-e182-4f23-9146-8adc4aa73e65 69189-0317 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20150603 ANDA ANDA083386 Avera McKennan Hospital CHLORPROMAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 69189-0325_3a40b9a3-fb61-4471-bc43-88d5242ab9ef 69189-0325 HUMAN PRESCRIPTION DRUG Moexipril Hydrochloride Moexipril Hydrochloride TABLET, FILM COATED ORAL 20150810 ANDA ANDA090416 Avera McKennan Hospital MOEXIPRIL HYDROCHLORIDE 7.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 69189-0334_82d0a12c-f383-4146-9f8d-b5911e92c807 69189-0334 HUMAN PRESCRIPTION DRUG Leflunomide Leflunomide TABLET ORAL 20150301 ANDA ANDA091369 Avera McKennan Hospital LEFLUNOMIDE 20 mg/1 Antirheumatic Agent [EPC] E 20171231 69189-0335_c17a160d-4c64-4e6b-a004-1fb56adbba30 69189-0335 HUMAN PRESCRIPTION DRUG albuterol sulfate albuterol sulfate TABLET ORAL 20150909 ANDA ANDA072637 Avera McKennan Hospital ALBUTEROL SULFATE 2 mg/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 69189-0341_8fe33f34-0f2b-4264-9beb-736b84c82020 69189-0341 HUMAN PRESCRIPTION DRUG Quinapril Quinapril TABLET ORAL 20150916 ANDA ANDA078457 Avera McKennan Hospital QUINAPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69189-0344_e0a97da7-1323-4550-915f-264de8eec5cd 69189-0344 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20150916 ANDA ANDA090858 Avera McKennan Hospital GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 69189-0345_e99aa451-eb01-4027-adc3-1106e18b0453 69189-0345 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 20150406 ANDA ANDA070994 Avera McKennan Hospital VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 69189-0346_8c8b5e57-a695-46e3-a342-0aa1f4312e80 69189-0346 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20150911 ANDA ANDA074700 Avera McKennan Hospital BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 69189-0350_94cca1e0-0be8-45ff-9ec6-36e67a7a3020 69189-0350 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 20150715 ANDA ANDA062882 Avera McKennan Hospital AMPICILLIN TRIHYDRATE 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 69189-0354_50aafeb4-b6d0-4ee0-ade3-6356d05084ab 69189-0354 HUMAN PRESCRIPTION DRUG AMICAR Aminocaproic Acid TABLET ORAL 20150923 NDA NDA015197 Avera McKennan Hospital AMINOCAPROIC ACID 500 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 69189-0355_cc3d31b1-6f29-4745-9686-b336f95a5907 69189-0355 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20150923 NDA AUTHORIZED GENERIC NDA020796 Avera McKennan Hospital ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] E 20171231 69189-0362_f1f8fa07-14c8-41bc-ae61-ec7e5d1f88ca 69189-0362 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20150928 ANDA ANDA074700 Avera McKennan Hospital BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 69189-0365_1048615c-8b24-4a42-810b-213c61f3e2fa 69189-0365 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET ORAL 20150825 UNAPPROVED DRUG OTHER Avera McKennan Hospital SALSALATE 500 mg/1 N 20181231 69189-0371_e5dda943-0b05-4256-a519-19c0bb8723ad 69189-0371 HUMAN PRESCRIPTION DRUG EDECRIN ethacrynic acid TABLET ORAL 20151002 NDA NDA016092 Avera McKennan Hospital ETHACRYNIC ACID 25 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 69189-0372_74967d09-069a-4a55-9e5d-1c0c79412654 69189-0372 HUMAN OTC DRUG Leader Fiber Psyllium Husk CAPSULE ORAL 20150306 OTC MONOGRAPH NOT FINAL part334 Avera McKennan Hospital PSYLLIUM HUSK .52 g/1 E 20171231 69189-0374_b2d1cc4e-7649-428c-a566-15f296a5586a 69189-0374 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20151002 ANDA ANDA086923 Avera McKennan Hospital ISOSORBIDE DINITRATE 5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 69189-0376_8b642ccf-90da-48d8-bdd3-736bc2e6a566 69189-0376 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20150716 ANDA ANDA076570 Avera McKennan Hospital TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 69189-0382_dee64392-21e5-434f-97e8-25e624c6d37e 69189-0382 HUMAN PRESCRIPTION DRUG Cyclophosphamide Cyclophosphamide CAPSULE ORAL 20150818 NDA NDA203856 Avera McKennan Hospital CYCLOPHOSPHAMIDE 25 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 69189-0383_148d21b9-fe9e-4c7f-8eb1-537f7e68d416 69189-0383 HUMAN PRESCRIPTION DRUG Cyclophosphamide Cyclophosphamide CAPSULE ORAL 20150423 NDA NDA203856 Avera McKennan Hospital CYCLOPHOSPHAMIDE 50 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 69189-0385_357a6afc-99d8-4fc9-bfd8-ad634a042999 69189-0385 HUMAN PRESCRIPTION DRUG Myfortic mycophenolic acid TABLET, DELAYED RELEASE ORAL 20150301 NDA NDA050791 Avera McKennan Hospital MYCOPHENOLATE SODIUM 180 mg/1 Antimetabolite Immunosuppressant [EPC] E 20171231 69189-0387_097d0e39-046e-42b9-9b74-2ca2cf21cdbd 69189-0387 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20150821 ANDA ANDA072709 Avera McKennan Hospital MINOXIDIL 2.5 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 69189-0391_59a752ff-3224-4d6c-bf2c-951fc3fe4edf 69189-0391 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET ORAL 20150309 ANDA ANDA062505 Avera McKennan Hospital DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 69189-0399_0d748c68-d028-4b2d-bfce-2da913f6eccf 69189-0399 HUMAN PRESCRIPTION DRUG Cevimeline Hydrochloride Cevimeline Hydrochloride CAPSULE ORAL 20151030 ANDA ANDA091591 Avera McKennan Hospital CEVIMELINE HYDROCHLORIDE 30 mg/1 Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC] E 20171231 69189-0400_639a71c7-37d1-4e78-ac3b-742ccb41c6bd 69189-0400 HUMAN PRESCRIPTION DRUG Ethosuximide Ethosuximide CAPSULE ORAL 20151030 ANDA ANDA040686 Avera McKennan Hospital ETHOSUXIMIDE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 69189-0401_c0885491-e882-4237-90f2-60ebf43d72df 69189-0401 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED ORAL 20150518 NDA NDA021356 Avera McKennan Hospital TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 69189-0403_9dbe3583-1cfa-4e9f-85aa-11df5c30df71 69189-0403 HUMAN PRESCRIPTION DRUG Gleevec imatinib mesylate TABLET ORAL 20150301 NDA NDA021588 Avera McKennan Hospital IMATINIB MESYLATE 100 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] E 20171231 69189-0404_061afada-3ac5-4d00-ab59-2b55c72a185d 69189-0404 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 20150306 ANDA ANDA072924 Avera McKennan Hospital VERAPAMIL HYDROCHLORIDE 40 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 69189-0408_7516f0c8-bb85-4aa1-bd44-fe79b3f50f65 69189-0408 HUMAN PRESCRIPTION DRUG Meprobamate Meprobamate TABLET ORAL 20151103 ANDA ANDA090122 Avera McKennan Hospital MEPROBAMATE 200 mg/1 CIV E 20171231 69189-0410_0d939182-203f-4414-b3f2-4ad3fac8440e 69189-0410 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20150608 NDA AUTHORIZED GENERIC NDA020712 Avera McKennan Hospital CARBAMAZEPINE 300 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 69189-0411_f5ac1d94-f2b6-42c0-a07a-cd88c5d0d520 69189-0411 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20151104 ANDA ANDA078251 Avera McKennan Hospital CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 69189-0413_6e1ee8b0-ead5-44fb-9c65-baf5b1f3a514 69189-0413 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol TABLET, FILM COATED ORAL 20150818 ANDA ANDA202540 Avera McKennan Hospital URSODIOL 250 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] E 20171231 69189-0414_fc03b6a5-4ef3-4bde-8fc2-368cf60732db 69189-0414 HUMAN PRESCRIPTION DRUG Estropipate Estropipate TABLET ORAL 20160205 ANDA ANDA081213 Avera McKennan Hospital ESTROPIPATE .75 mg/1 N 20181231 69189-0415_96c8367b-258e-4794-8a01-0dfd62d9db8a 69189-0415 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20150406 ANDA ANDA085762 Avera McKennan Hospital DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV E 20171231 69189-0416_f075e011-a276-4007-b9e9-d2f2da31fb3c 69189-0416 HUMAN PRESCRIPTION DRUG Estropipate Estropipate TABLET ORAL 20150707 ANDA ANDA081214 Avera McKennan Hospital ESTROPIPATE 1.5 mg/1 N 20181231 69189-0418_965171d8-d3c9-4501-949b-a9fe2fe71d05 69189-0418 HUMAN PRESCRIPTION DRUG Raloxifene hydrochloride Raloxifene hydrochloride TABLET ORAL 20150301 NDA AUTHORIZED GENERIC NDA020815 Avera McKennan Hospital RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] E 20171231 69189-0419_0b1c7f4e-6445-4718-8372-c01a5d8b0cda 69189-0419 HUMAN PRESCRIPTION DRUG Zetia Ezetimibe TABLET ORAL 20150709 NDA NDA021445 Avera McKennan Hospital EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] E 20171231 69189-0420_2acabce1-2aae-4282-bc86-365ee0d06a69 69189-0420 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20151105 ANDA ANDA088629 Avera McKennan Hospital ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 69189-0421_2b410242-5c83-4c60-8e38-3715bb6e2068 69189-0421 HUMAN OTC DRUG Senokot standardized senna concentrate TABLET ORAL 20151104 OTC MONOGRAPH NOT FINAL part334 Avera McKennan Hospital SENNOSIDES 8.6 mg/1 E 20171231 69189-0423_70dcd7d5-43aa-43bd-a400-e8326270d9d4 69189-0423 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20151110 ANDA ANDA078384 Avera McKennan Hospital CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 69189-0425_f73e820f-85f3-4a96-91b8-884de771fa1c 69189-0425 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20150601 ANDA ANDA076447 Avera McKennan Hospital FEXOFENADINE HYDROCHLORIDE 60 mg/1 E 20171231 69189-0427_78e02908-af73-4de0-84eb-3a3063ca252f 69189-0427 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20151111 ANDA ANDA078384 Avera McKennan Hospital CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 69189-0428_854bb1dc-5bc5-480d-8d29-dc4bdbf173fa 69189-0428 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20151117 ANDA ANDA087184 Avera McKennan Hospital DIPYRIDAMOLE 25 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] E 20171231 69189-0434_c3eedf48-535a-4acd-84df-3ff3d30b5824 69189-0434 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20150101 ANDA ANDA076118 Avera McKennan Hospital BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 69189-0436_fca40964-5739-4215-9cce-224d10456aea 69189-0436 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET ORAL 20151028 NDA AUTHORIZED GENERIC NDA012836 Avera McKennan Hospital DIPYRIDAMOLE 75 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 69189-0437_ec70d664-3225-46cf-9432-de5cdc3ca123 69189-0437 HUMAN PRESCRIPTION DRUG Acamprosate Calcium Acamprosate Calcium TABLET, DELAYED RELEASE ORAL 20150817 ANDA ANDA202229 Avera McKennan Hospital ACAMPROSATE CALCIUM 333 mg/1 E 20171231 69189-0443_7f788e84-741b-4dbb-98cd-343d3c10e0a5 69189-0443 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151202 ANDA ANDA077410 Avera McKennan Hospital NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 69189-0449_7c664881-3f2c-4863-a451-70b4e8039f52 69189-0449 HUMAN OTC DRUG Fiber Laxative Calcium Polycarbophil TABLET ORAL 20150304 OTC MONOGRAPH NOT FINAL part334 Avera McKennan Hospital CALCIUM POLYCARBOPHIL 625 mg/1 E 20171231 69189-0450_7bbac2ef-6064-4511-a837-9319b4f4d45a 69189-0450 HUMAN PRESCRIPTION DRUG Colestipol Hydrochloride Colestipol Hydrochloride TABLET ORAL 20150320 NDA AUTHORIZED GENERIC NDA020222 Avera McKennan Hospital COLESTIPOL HYDROCHLORIDE 1 g/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 69189-0457_07467ff6-f16e-4284-ae1d-9ee3a1d64071 69189-0457 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate TABLET ORAL 20151222 NDA NDA022207 Avera McKennan Hospital MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 69189-0462_70fc6269-ba2d-40b6-816f-4156e8b7faa9 69189-0462 HUMAN PRESCRIPTION DRUG Pimozide Pimozide TABLET ORAL 20160107 ANDA ANDA204521 Avera McKennan Hospital PIMOZIDE 2 mg/1 Typical Antipsychotic [EPC] N 20181231 69189-0463_e5040aec-ea02-4f01-a4a0-c179e593e1cc 69189-0463 HUMAN PRESCRIPTION DRUG CLOZAPINE CLOZAPINE TABLET ORAL 20160108 ANDA ANDA075713 Avera McKennan Hospital CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-0464_7013d0a5-16b8-4617-a1c1-ed055c8039ff 69189-0464 HUMAN PRESCRIPTION DRUG Tretinoin Tretinoin CAPSULE ORAL 20160108 ANDA ANDA201687 Avera McKennan Hospital TRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 69189-0465_5a9f9183-5a24-49ae-991f-23c3b06aae41 69189-0465 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20160108 ANDA ANDA077621 Avera McKennan Hospital AZATHIOPRINE 50 1/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 69189-0466_9d5ef561-8222-46e3-8495-44bbdb805450 69189-0466 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Extended-Release Hyoscyamine Sulfate Extended-Release TABLET ORAL 20160111 UNAPPROVED DRUG OTHER Avera McKennan Hospital HYOSCYAMINE SULFATE .375 mg/1 N 20181231 69189-0468_37444569-ab9d-4696-985e-bc7196635642 69189-0468 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20150421 ANDA ANDA071973 Avera McKennan Hospital PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 69189-0470_1263e968-1e09-42a5-b11b-5bac1009e122 69189-0470 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20150408 ANDA ANDA071974 Avera McKennan Hospital PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 69189-0472_8345c166-96c1-40fe-a121-419e5a3613cf 69189-0472 HUMAN PRESCRIPTION DRUG ADCIRCA Tadalafil TABLET ORAL 20151028 NDA NDA022332 Avera McKennan Hospital TADALAFIL 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 69189-0475_55b3c785-c3a7-4d68-8af6-06aeb70f5274 69189-0475 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20150507 ANDA ANDA091604 Avera McKennan Hospital RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69189-0476_27731452-092d-4187-8e70-a3234d1c5bbd 69189-0476 HUMAN PRESCRIPTION DRUG Lialda mesalamine TABLET, DELAYED RELEASE ORAL 20150403 NDA NDA022000 Avera McKennan Hospital MESALAMINE 1.2 g/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 69189-0478_e5b7b0cc-1742-4d3c-89af-4e5af6c00c9a 69189-0478 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20160111 NDA NDA021995 Avera McKennan Hospital SITAGLIPTIN PHOSPHATE 50 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 69189-0479_96f8af52-887e-4bae-a14d-ed19177eb7a7 69189-0479 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20160111 ANDA ANDA076346 Avera McKennan Hospital TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 69189-0482_5698e01d-afb4-49ed-8049-050c0cf4040c 69189-0482 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20160112 ANDA ANDA040439 Avera McKennan Hospital DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 69189-0484_adff3967-150b-47c7-b047-03458ee7a47d 69189-0484 HUMAN PRESCRIPTION DRUG SEROQUEL XR Quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20160113 NDA NDA022047 Avera McKennan Hospital QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-0485_bba68ca1-1586-4eb5-8a67-d71e270f95d1 69189-0485 HUMAN PRESCRIPTION DRUG Tekturna aliskiren hemifumarate TABLET, FILM COATED ORAL 20150908 NDA NDA021985 Avera McKennan Hospital ALISKIREN HEMIFUMARATE 150 mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA] N 20181231 69189-0487_1da664d9-7bdf-4785-b4dc-f4fea121a235 69189-0487 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20150623 ANDA ANDA040114 Avera McKennan Hospital ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 69189-0488_ad5196f7-47de-4dcf-a34b-c6d3bce217a0 69189-0488 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20160115 ANDA ANDA078155 Avera McKennan Hospital SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69189-0489_d5e1fd8c-8e2a-4b7d-b74d-afb380682fe1 69189-0489 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride and Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20160118 NDA AUTHORIZED GENERIC NDA012750 Avera McKennan Hospital CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] N 20181231 69189-0491_caac3a92-17c7-4544-8b89-2156cb33881c 69189-0491 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20160120 UNAPPROVED DRUG OTHER Avera McKennan Hospital PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 69189-0492_e019fbcd-8038-4b99-91fe-e94adec0650d 69189-0492 HUMAN PRESCRIPTION DRUG CHANTIX varenicline tartrate TABLET, FILM COATED ORAL 20160122 NDA NDA021928 Avera McKennan Hospital VARENICLINE TARTRATE .5 mg/1 Partial Cholinergic Nicotinic Agonist [EPC],Partial Cholinergic Nicotinic Agonists [MoA] N 20181231 69189-0493_3fd4932e-5a97-4239-b517-d4337f2a737f 69189-0493 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20160122 ANDA ANDA077147 Avera McKennan Hospital CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 69189-0494_80fed7ba-8335-4c6a-a069-8f0d7aee59fc 69189-0494 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20150309 NDA AUTHORIZED GENERIC NDA020405 Avera McKennan Hospital DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 69189-0495_43cc4573-36f2-435c-bef6-be26aafba0ff 69189-0495 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20160126 ANDA ANDA090749 Avera McKennan Hospital QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-0496_46eb42ec-47f6-47cc-82b2-6ecf439b4da1 69189-0496 HUMAN PRESCRIPTION DRUG Timolol Maleate timolol maleate TABLET ORAL 20160127 ANDA ANDA072668 Avera McKennan Hospital TIMOLOL MALEATE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 69189-0497_99114244-6714-4302-930c-444ea21f70ab 69189-0497 HUMAN PRESCRIPTION DRUG DRISDOL Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20160205 NDA NDA003444 Avera McKennan Hospital ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 69189-0498_b7e89829-e349-4f4b-9a58-d9787ea2af0d 69189-0498 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20160210 ANDA ANDA203044 Avera McKennan Hospital OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-0499_27fa185e-7ff3-4cf1-813a-5ebc6047dad2 69189-0499 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20160210 ANDA ANDA075274 Avera McKennan Hospital NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 69189-0501_513e90d3-f955-486e-bc84-cceaba494f7a 69189-0501 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride CAPSULE ORAL 20150624 ANDA ANDA074928 Avera McKennan Hospital NICARDIPINE HYDROCHLORIDE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69189-0503_01dfd2bd-3b97-4293-9fa7-5e1a9619fbd8 69189-0503 HUMAN PRESCRIPTION DRUG Ursodiol Ursodiol CAPSULE ORAL 20150227 ANDA ANDA075517 Avera McKennan Hospital URSODIOL 300 mg/1 Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] E 20171231 69189-0509_6e560855-f882-491d-9126-e54ca651c05c 69189-0509 HUMAN PRESCRIPTION DRUG Zidovudine Zidovudine TABLET ORAL 20160127 ANDA ANDA090092 Avera McKennan Hospital ZIDOVUDINE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 69189-0510_ce4b8129-b303-4296-9f80-765b44558f08 69189-0510 HUMAN PRESCRIPTION DRUG Tegretol XR carbamazepine TABLET, EXTENDED RELEASE ORAL 20150514 NDA NDA020234 Avera McKennan Hospital CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 69189-0514_5ddf874e-da33-4f0b-b304-dc74dc91e9e2 69189-0514 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20150302 NDA AUTHORIZED GENERIC NDA020405 Avera McKennan Hospital DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 69189-0517_9204fe2e-9bb4-4730-95e5-36f652b1d656 69189-0517 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20150615 ANDA ANDA040635 Avera McKennan Hospital BETHANECHOL CHLORIDE 25 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 69189-0521_90063d89-0105-402c-ad3c-4447e2aaacb2 69189-0521 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20160215 ANDA ANDA202127 Avera McKennan Hospital CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 69189-0523_9ae418aa-b0f6-4013-9220-02cc1dda8bf4 69189-0523 HUMAN PRESCRIPTION DRUG Armour Thyroid THYROID, PORCINE TABLET ORAL 20160215 UNAPPROVED DRUG OTHER Avera McKennan Hospital THYROID, PORCINE 30 mg/1 N 20181231 69189-0524_8eb2a967-7b05-495f-97d9-5174ee8b4b93 69189-0524 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160215 ANDA ANDA076467 Avera McKennan Hospital GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 69189-0525_523f08c4-c104-4f3c-9e0e-71bc612f6a2c 69189-0525 HUMAN PRESCRIPTION DRUG Imipramine Pamoate Imipramine Pamoate CAPSULE ORAL 20160215 ANDA ANDA091099 Avera McKennan Hospital IMIPRAMINE PAMOATE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69189-0526_f58d2859-62eb-49f3-9417-dbcfc6eb1547 69189-0526 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160218 ANDA ANDA091544 Avera McKennan Hospital LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 69189-0527_50f1e788-018b-41bb-a99e-d648a1ca1c7a 69189-0527 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160121 ANDA ANDA200834 Avera McKennan Hospital VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69189-0529_a2d53c32-78cc-4b34-aa24-659116bf5567 69189-0529 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150727 ANDA ANDA200834 Avera McKennan Hospital VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 69189-0530_b66f9ac9-86af-4b9d-bd95-0b7a3e5e8eec 69189-0530 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20151029 ANDA ANDA079234 Avera McKennan Hospital TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 69189-0531_a8becd91-a35f-4a24-b07e-21a6c1e513d4 69189-0531 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20160126 ANDA ANDA079234 Avera McKennan Hospital TORSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 69189-0534_bb109133-6bb2-4af6-86ed-a1f9c7d55ffa 69189-0534 HUMAN PRESCRIPTION DRUG Guanfacine Extended-Release Guanfacine TABLET, EXTENDED RELEASE ORAL 20151016 ANDA ANDA201408 Avera McKennan Hospital GUANFACINE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 69189-0538_cafcacfc-58a4-4968-aa64-07c4fc0c1b72 69189-0538 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20160219 ANDA ANDA090515 Avera McKennan Hospital LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69189-0539_a7739ecf-d2d7-4148-bb5d-d49652fc1847 69189-0539 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151014 ANDA ANDA200484 Avera McKennan Hospital NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 69189-0545_a20abe63-99b0-4f5d-ac8a-0bc7a699f924 69189-0545 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20150414 ANDA ANDA040866 Avera McKennan Hospital PRIMIDONE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69189-0547_bfe850bc-5e10-4e3b-80b5-94490099f202 69189-0547 HUMAN PRESCRIPTION DRUG Abacavir Abacavir TABLET, FILM COATED ORAL 20160229 ANDA ANDA077844 Avera McKennan Hospital ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 69189-0548_871fc242-59f4-452d-af02-7e3985f11e3b 69189-0548 HUMAN PRESCRIPTION DRUG DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE TABLET ORAL 20160302 ANDA ANDA090652 Avera McKennan Hospital DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 69189-0549_5b9408ef-8531-4893-a053-7f3af2b383d7 69189-0549 HUMAN PRESCRIPTION DRUG rifabutin rifabutin CAPSULE ORAL 20160303 ANDA ANDA090033 Avera McKennan Hospital RIFABUTIN 150 mg/1 Rifamycin Antimycobacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 69189-0551_f5177e24-1843-46de-8c81-6f87ad910433 69189-0551 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20150529 NDA NDA021999 Avera McKennan Hospital PALIPERIDONE 6 mg/1 Atypical Antipsychotic [EPC] E 20171231 69189-0554_640a64fa-a522-462e-aa5f-18870dfeeee4 69189-0554 HUMAN PRESCRIPTION DRUG INVEGA paliperidone TABLET, EXTENDED RELEASE ORAL 20150824 NDA NDA021999 Avera McKennan Hospital PALIPERIDONE 1.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-0559_6f46d7c0-984c-4b18-8d70-8e390221e436 69189-0559 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20150318 ANDA ANDA202038 Avera McKennan Hospital PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 69189-0560_6ee1ed01-7b8e-43f5-9d0b-bca0e2a0b73f 69189-0560 HUMAN PRESCRIPTION DRUG Brintellix vortioxetine TABLET, FILM COATED ORAL 20150605 NDA NDA204447 Avera McKennan Hospital VORTIOXETINE HYDROBROMIDE 10 mg/1 E 20171231 69189-0566_5419c7f5-fb50-4fab-9f5e-cb3366b0a0fb 69189-0566 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20151005 NDA NDA021976 Avera McKennan Hospital DARUNAVIR ETHANOLATE 800 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 69189-0571_3154a71a-517f-4960-ac3b-653dc76e39c7 69189-0571 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20150319 ANDA ANDA040855 Avera McKennan Hospital BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] E 20171231 69189-0572_08db55c7-16a1-4887-a23e-4fd90b33faec 69189-0572 HUMAN PRESCRIPTION DRUG voriconazole voriconazole TABLET, FILM COATED ORAL 20160226 ANDA ANDA203503 Avera McKennan Hospital VORICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 69189-0574_0976a800-c144-46c0-a936-c8ac277da22f 69189-0574 HUMAN PRESCRIPTION DRUG CRIXIVAN indinavir sulfate CAPSULE ORAL 20150301 NDA NDA020685 Avera McKennan Hospital INDINAVIR SULFATE 400 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA] E 20171231 69189-0575_3023339b-72a1-4387-9d27-80ef66ce7f1d 69189-0575 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20160304 ANDA ANDA204821 Avera McKennan Hospital VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 69189-0576_339626a1-bb20-4ba9-bbc6-1df40b3f9e2a 69189-0576 HUMAN PRESCRIPTION DRUG Bethanechol Chloride Bethanechol Chloride TABLET ORAL 20160310 ANDA ANDA040633 Avera McKennan Hospital BETHANECHOL CHLORIDE 5 mg/1 Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] N 20181231 69189-0577_87213ac8-52c1-4df4-9e46-678a382e8eef 69189-0577 HUMAN PRESCRIPTION DRUG Amiloride Hydrochloride and Hydrochlorothiazide amiloride hydrochloride and hydrochlorothiazide TABLET ORAL 20160126 ANDA ANDA073209 Avera McKennan Hospital AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE 5; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69189-0578_d960fd15-08c7-4f83-91a1-de864e88c243 69189-0578 HUMAN PRESCRIPTION DRUG Xarelto rivaroxaban TABLET, FILM COATED ORAL 20150316 NDA NDA202439 Avera McKennan Hospital RIVAROXABAN 15 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] E 20171231 69189-0579_2c27c6d2-c04e-4c76-865f-751d7e07a175 69189-0579 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20160310 ANDA ANDA080936 Avera McKennan Hospital ISONIAZID 100 mg/1 Antimycobacterial [EPC] N 20181231 69189-0580_38a62428-bdec-416c-aba8-b73e48947689 69189-0580 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20160311 ANDA ANDA201504 Avera McKennan Hospital QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-0583_f06a768c-a2fc-43bb-985d-8278a6e4bff3 69189-0583 HUMAN PRESCRIPTION DRUG Propafenone HCl Propafenone hydrochloride TABLET, FILM COATED ORAL 20151001 ANDA ANDA075203 Avera McKennan Hospital PROPAFENONE HYDROCHLORIDE 225 mg/1 Antiarrhythmic [EPC] E 20171231 69189-0587_d756ca59-edf3-40a4-9453-7dac2aa9ede6 69189-0587 HUMAN PRESCRIPTION DRUG Nystatin Nystatin TABLET, COATED ORAL 20160321 ANDA ANDA062474 Avera McKennan Hospital NYSTATIN 500000 [USP'U]/1 Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 69189-0589_2be3cf81-6ccf-4495-9336-d8a6a3bd1dac 69189-0589 HUMAN PRESCRIPTION DRUG sotalol hydrochloride sotalol hydrochloride TABLET ORAL 20160224 ANDA ANDA075366 Avera McKennan Hospital SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 69189-0591_4e8c19fd-ad5d-461b-adad-466da9e0452d 69189-0591 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride and naloxone hydrochloride dihydrate buprenorphine hydrochloride and naloxone hydrochloride dihydrate TABLET SUBLINGUAL 20160324 ANDA ANDA203326 Avera McKennan Hospital BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE 2; .5 mg/1; mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA],Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 69189-0592_4481e014-39a6-47a1-b06c-af4a6630be37 69189-0592 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20160325 UNAPPROVED DRUG OTHER Avera McKennan Hospital PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 69189-0593_625598da-3e4a-4385-92ee-93b1d9f4198b 69189-0593 HUMAN PRESCRIPTION DRUG Dipyridamole Dipyridamole TABLET, FILM COATED ORAL 20160329 ANDA ANDA087716 Avera McKennan Hospital DIPYRIDAMOLE 50 mg/1 Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 69189-0597_0e466fcb-7c75-4bb6-bcf1-f4d2451e8190 69189-0597 HUMAN PRESCRIPTION DRUG FANAPT Iloperidone TABLET ORAL 20150602 NDA NDA022192 Avera McKennan Hospital ILOPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-0599_41dd4829-0184-47be-b8e0-a06f08ad124e 69189-0599 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20160405 NDA NDA018851 Avera McKennan Hospital INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69189-0602_6b62b6bd-cbd2-41be-9f7c-434abae09762 69189-0602 HUMAN PRESCRIPTION DRUG Tiagabine Hydrochloride Tiagabine Hydrochloride TABLET, FILM COATED ORAL 20150310 NDA AUTHORIZED GENERIC NDA020646 Avera McKennan Hospital TIAGABINE HYDROCHLORIDE 4 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69189-0605_14f74d99-6a4c-427f-9531-08222ca4e9dc 69189-0605 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Moxifloxacin Hydrochloride TABLET, FILM COATED ORAL 20150522 ANDA ANDA202632 Avera McKennan Hospital MOXIFLOXACIN HYDROCHLORIDE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 69189-0606_67e11393-ce30-4b95-a9d1-04b7bee4cc8d 69189-0606 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20160405 ANDA ANDA090554 Avera McKennan Hospital DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 69189-0608_91611ed6-da66-4e1a-bf78-8bfbe75b1b0d 69189-0608 HUMAN PRESCRIPTION DRUG Megestrol Acetate Megestrol Acetate TABLET ORAL 20150302 ANDA ANDA074621 Avera McKennan Hospital MEGESTROL ACETATE 40 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 69189-0609_bdf8c00c-e844-4af6-9a7d-bcaa62d47414 69189-0609 HUMAN PRESCRIPTION DRUG MINOXIDIL minoxidil TABLET ORAL 20160406 ANDA ANDA072709 Avera McKennan Hospital MINOXIDIL 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 69189-0610_8dd9b137-e3b0-4311-8659-9fb35a8d280b 69189-0610 HUMAN PRESCRIPTION DRUG Divalproex Sodium Extended-Release Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20160413 ANDA ANDA078445 Avera McKennan Hospital DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 69189-0613_3e323948-7555-4175-9e90-49e0c4b1c5a2 69189-0613 HUMAN PRESCRIPTION DRUG NIACIN NIACIN TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160118 ANDA ANDA200484 Avera McKennan Hospital NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 69189-0614_ace4dcfb-775a-47d3-af9c-be4377859941 69189-0614 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160418 ANDA ANDA078428 Avera McKennan Hospital GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69189-0615_b393bdee-7c2c-475f-afc2-06b7cf331323 69189-0615 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20150301 ANDA ANDA086183 Avera McKennan Hospital HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 69189-0616_026bc5b0-937f-4228-9f37-899cfca4cf49 69189-0616 HUMAN PRESCRIPTION DRUG Methyldopa Methyldopa TABLET, FILM COATED ORAL 20160418 ANDA ANDA070085 Avera McKennan Hospital METHYLDOPA 500 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 69189-0619_041e6845-1c24-487a-803c-54fde904f652 69189-0619 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride EXTENDED RELEASE diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20160419 NDA AUTHORIZED GENERIC NDA020401 Avera McKennan Hospital DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 69189-0622_d5f318d6-ed72-42b9-963e-6648303cc154 69189-0622 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20160425 ANDA ANDA084769 Avera McKennan Hospital CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 69189-0630_f5d409ed-5127-4d78-ac33-2d43ab5bff5a 69189-0630 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20160512 ANDA ANDA078627 Avera McKennan Hospital VENLAFAXINE HYDROCHLORIDE 25 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69189-0633_41e729a3-f8f5-4139-95e9-ccaeb9c438ad 69189-0633 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20160519 ANDA ANDA065434 Avera McKennan Hospital CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 69189-0634_ecac3dc1-2de4-4854-b0d9-215bb1d77e60 69189-0634 HUMAN PRESCRIPTION DRUG Dexmethylphenidate hydrochloride Dexmethylphenidate hydrochloride TABLET ORAL 20160524 ANDA ANDA201231 Avera McKennan Hospital DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 69189-0635_e45dc551-9419-46af-a606-d2436242063b 69189-0635 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20160526 ANDA ANDA203578 Avera McKennan Hospital NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 69189-0636_18cd8243-9998-46b3-a1ac-3f531c46aa17 69189-0636 HUMAN PRESCRIPTION DRUG Sulindac sulindac TABLET ORAL 20160602 ANDA ANDA073039 Avera McKennan Hospital SULINDAC 150 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69189-0637_da38be15-837d-4f17-8f6b-94a2cbde06aa 69189-0637 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride Nicardipine Hydrochloride CAPSULE ORAL 20160606 ANDA ANDA074928 Avera McKennan Hospital NICARDIPINE HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69189-0638_e0b20ee4-2775-47e8-b0b3-45980b0f1aa9 69189-0638 HUMAN PRESCRIPTION DRUG Zafirlukast zafirlukast TABLET, COATED ORAL 20160606 NDA NDA020547 Avera McKennan Hospital ZAFIRLUKAST 20 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 69189-0639_d3c8857d-40dc-4f83-91d4-78fde13541d3 69189-0639 HUMAN PRESCRIPTION DRUG Exelon rivastigmine tartrate CAPSULE ORAL 20160607 NDA NDA020823 Avera McKennan Hospital RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 69189-0640_4e843d09-43a9-4458-baed-fafcb8b913a9 69189-0640 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride/Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20160614 UNAPPROVED DRUG OTHER Avera McKennan Hospital CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] N 20181231 69189-0641_2cbb36d1-a123-456c-ab08-a3e52d206b58 69189-0641 HUMAN PRESCRIPTION DRUG Flecainide Acetate Flecainide Acetate TABLET ORAL 20151029 ANDA ANDA075442 Avera McKennan Hospital FLECAINIDE ACETATE 50 mg/1 Antiarrhythmic [EPC] E 20171231 69189-0642_0213378c-31e8-4199-a160-5bfe7b49389a 69189-0642 HUMAN PRESCRIPTION DRUG REXULTI brexpiprazole TABLET ORAL 20160617 NDA NDA205422 Avera McKennan Hospital BREXPIPRAZOLE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-0643_2eb82caa-80f7-4c07-8502-5dcd6dfb1fc2 69189-0643 HUMAN PRESCRIPTION DRUG metolazone metolazone TABLET ORAL 20150416 NDA AUTHORIZED GENERIC NDA017386 Avera McKennan Hospital METOLAZONE 2.5 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] E 20171231 69189-0644_a9704673-01fa-45bf-a526-b66b42314dcb 69189-0644 HUMAN PRESCRIPTION DRUG Nitro-Time Nitroglycerin CAPSULE ORAL 20150424 UNAPPROVED DRUG OTHER Avera McKennan Hospital NITROGLYCERIN 6.5 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 69189-0649_3d2d5cbe-681f-42eb-9ade-0bf11722e0fa 69189-0649 HUMAN PRESCRIPTION DRUG Niacin Niacin TABLET, EXTENDED RELEASE ORAL 20160623 ANDA ANDA203578 Avera McKennan Hospital NIACIN 1000 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 69189-0652_6e5e9b69-279d-467f-9181-dd22984b5137 69189-0652 HUMAN PRESCRIPTION DRUG Methergine Methylergonovine maleate TABLET ORAL 20160623 ANDA ANDA091577 Avera McKennan Hospital METHYLERGONOVINE MALEATE .2 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 69189-0653_9c518071-2aea-4594-88c5-229cac416c83 69189-0653 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20160624 ANDA ANDA071524 Avera McKennan Hospital TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 69189-0654_2e66e14a-696d-4812-b7cc-570af93f6273 69189-0654 HUMAN PRESCRIPTION DRUG Entacapone Entacapone TABLET, FILM COATED ORAL 20160108 ANDA ANDA203437 Avera McKennan Hospital ENTACAPONE 200 mg/1 Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC] N 20181231 69189-0656_0c12cd8a-0edb-4052-a62d-c8351343c7c1 69189-0656 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine TABLET ORAL 20160627 ANDA ANDA078627 Avera McKennan Hospital VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69189-0657_c536712c-7f7f-428f-b524-8ff30c00ef72 69189-0657 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20160628 ANDA ANDA076801 Avera McKennan Hospital PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 69189-0663_9ea3085d-7b75-487d-9ce9-2fb1b6559ee0 69189-0663 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20160630 ANDA ANDA202424 Avera McKennan Hospital DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 69189-0664_01644dbb-5830-4481-aea7-fb1c22df86ea 69189-0664 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET ORAL 20160701 ANDA ANDA071881 Avera McKennan Hospital VERAPAMIL HYDROCHLORIDE 40 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 69189-0665_9cfe65cc-b53f-4931-b5ed-ad695227ee97 69189-0665 HUMAN PRESCRIPTION DRUG Fanapt iloperidone TABLET ORAL 20160701 NDA NDA022192 Avera McKennan Hospital ILOPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-0666_42ad2f92-af0e-4f34-ae2c-9ef16a8ec615 69189-0666 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 20160701 ANDA ANDA040284 Avera McKennan Hospital ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 69189-0667_705369e1-9177-4fe4-8657-02288e0b23a4 69189-0667 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate isosorbide dinitrate TABLET ORAL 20160705 ANDA ANDA087537 Avera McKennan Hospital ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 69189-0670_f0e1a125-78ec-401d-8831-a8fa2ba9ebea 69189-0670 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20160708 ANDA ANDA075927 Avera McKennan Hospital NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69189-0672_b6924651-d1e3-4546-99de-91fb572c570e 69189-0672 HUMAN PRESCRIPTION DRUG Levocarnitine Levocarnitine TABLET ORAL 20160712 NDA NDA018948 Avera McKennan Hospital LEVOCARNITINE 330 mg/1 Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] N 20181231 69189-0673_f7ba54d3-7e03-49eb-bd94-c3cdcac3d6d5 69189-0673 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20160714 ANDA ANDA071976 Avera McKennan Hospital PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 69189-0676_326259ad-5289-4cd7-bf8c-6913e4f867db 69189-0676 HUMAN PRESCRIPTION DRUG Orenitram treprostinil TABLET, EXTENDED RELEASE ORAL 20160720 NDA NDA203496 Avera McKennan Hospital TREPROSTINIL 2.5 mg/1 Prostacycline Vasodilator [EPC],Prostaglandins I [Chemical/Ingredient],Vasodilation [PE] N 20181231 69189-0677_b5c225ff-fa89-425f-90c5-75ebdf32c6f0 69189-0677 HUMAN PRESCRIPTION DRUG Nifedipine Extended Release Nifedipine TABLET, EXTENDED RELEASE ORAL 20150327 ANDA ANDA077899 Avera McKennan Hospital NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 69189-0678_274a9b9e-6564-41c5-8c90-9a248920b990 69189-0678 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20160721 ANDA ANDA208206 Avera McKennan Hospital RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 69189-0679_ce739d48-7487-42d3-a210-c6daec5ef02c 69189-0679 HUMAN PRESCRIPTION DRUG ANZEMET dolasetron mesylate TABLET, FILM COATED ORAL 20160726 NDA NDA020623 Avera McKennan Hospital DOLASETRON MESYLATE 100 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 69189-0683_4a5c50bf-feaa-4296-a1b2-f2762733cb7c 69189-0683 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160801 ANDA ANDA090858 Avera McKennan Hospital GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69189-0684_cf12fc4d-0adf-47eb-b0f2-60b919ccd863 69189-0684 HUMAN PRESCRIPTION DRUG COUMADIN warfarin sodium TABLET ORAL 20160801 NDA NDA009218 Avera McKennan Hospital WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 69189-0688_109a9581-489b-4871-9147-dc30f6479656 69189-0688 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20160829 NDA AUTHORIZED GENERIC NDA021656 Avera McKennan Hospital FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 69189-0692_407e1ccb-df45-41d9-9dac-eb45916d8ed4 69189-0692 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160912 ANDA ANDA077899 Avera McKennan Hospital NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 69189-0693_74979d24-a564-46f9-adf1-cfeb7b7c3c8c 69189-0693 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20150608 ANDA ANDA065061 Avera McKennan Hospital CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] E 20171231 69189-0699_7e9dbc14-fe5b-4098-a5ec-f3aa1c1419db 69189-0699 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20160606 ANDA ANDA065308 Avera McKennan Hospital CEFUROXIME AXETIL 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 69189-0700_99e87851-2543-43f5-91fc-2c79451b9c28 69189-0700 HUMAN PRESCRIPTION DRUG Cefuroxime Axetil Cefuroxime Axetil TABLET ORAL 20160620 ANDA ANDA065308 Avera McKennan Hospital CEFUROXIME AXETIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 69189-0701_79dadcfd-c3a6-4ac9-8de7-e00d2b781a63 69189-0701 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20150501 NDA NDA021752 Avera McKennan Hospital EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 69189-0709_0a6f2e71-4eca-4155-bc9e-5411dc492b0b 69189-0709 HUMAN OTC DRUG Extra Strength Acetaminophen PM Acetaminophen,Diphenhydramine HCl TABLET, FILM COATED ORAL 20150306 OTC MONOGRAPH NOT FINAL part343 Avera McKennan Hospital ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 69189-0711_17f28a82-4db0-4ba5-93eb-4e55cc7de57e 69189-0711 HUMAN PRESCRIPTION DRUG Lodosyn carbidopa TABLET ORAL 20151113 NDA NDA017830 Avera McKennan Hospital CARBIDOPA 25 mg/1 E 20171231 69189-0712_674d2b54-aabe-4d67-aa68-dfdaa1219bd0 69189-0712 HUMAN PRESCRIPTION DRUG AVODART dutasteride CAPSULE, LIQUID FILLED ORAL 20150323 NDA NDA021319 Avera McKennan Hospital DUTASTERIDE .5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] E 20171231 69189-0721_030e7acc-4854-4249-bd3f-8d87f8a81e96 69189-0721 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20161014 ANDA ANDA075090 Avera McKennan Hospital ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 69189-0722_f2e9021a-3632-40cd-8756-4e7c4ac8dcfa 69189-0722 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20161017 ANDA ANDA077253 Avera McKennan Hospital FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 69189-0723_3c26a262-7d3e-43d3-b327-b079cdbb039c 69189-0723 HUMAN OTC DRUG Plus Pharma Pain Reliever,Fever Reducer ACETAMINOPHEN TABLET ORAL 20161018 OTC MONOGRAPH NOT FINAL part343 Avera McKennan Hospital ACETAMINOPHEN 325 mg/1 N 20181231 69189-0725_510344f9-ece6-45db-b05e-e7e3aae6a622 69189-0725 HUMAN PRESCRIPTION DRUG JANUVIA sitagliptin TABLET, FILM COATED ORAL 20161020 NDA NDA021995 Avera McKennan Hospital SITAGLIPTIN PHOSPHATE 25 mg/1 Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA] N 20181231 69189-0730_0ed31a5d-0c21-4fd3-9ab1-99d157336755 69189-0730 HUMAN PRESCRIPTION DRUG Sensipar cinacalcet hydrochloride TABLET, COATED ORAL 20150317 NDA NDA021688 Avera McKennan Hospital CINACALCET HYDROCHLORIDE 30 mg/1 Calcium-sensing Receptor Agonist [EPC],Increased Calcium-sensing Receptor Sensitivity [MoA] E 20171231 69189-0732_d0e8379b-f48e-495b-8bf8-9d44d5678960 69189-0732 HUMAN PRESCRIPTION DRUG Trintellix vortioxetine TABLET, FILM COATED ORAL 20160620 NDA NDA204447 Avera McKennan Hospital VORTIOXETINE HYDROBROMIDE 10 mg/1 N 20181231 69189-0736_ef043431-ad1b-446b-a746-5932421b915a 69189-0736 HUMAN OTC DRUG Plus Pharma Calcium Antacid CALCIUM CARBONATE TABLET, CHEWABLE ORAL 20150311 OTC MONOGRAPH FINAL part331 Avera McKennan Hospital CALCIUM CARBONATE 500 mg/1 E 20171231 69189-0737_b0d4713a-a53e-4460-8267-3c206cb544b2 69189-0737 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20150313 ANDA ANDA090455 Avera McKennan Hospital ERGOCALCIFEROL 1.25 1/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] E 20171231 69189-0747_71e097a8-09fe-4223-bcfd-5939778c9a47 69189-0747 HUMAN PRESCRIPTION DRUG Biltricide praziquantel TABLET, FILM COATED ORAL 20150527 NDA NDA018714 Avera McKennan Hospital PRAZIQUANTEL 600 mg/1 Antihelminthic [EPC] N 20181231 69189-0752_2e93067b-bc8b-4b88-b256-59efab5167b5 69189-0752 HUMAN PRESCRIPTION DRUG CRESTOR Rosuvastatin calcium TABLET, FILM COATED ORAL 20160413 NDA NDA021366 Avera McKennan Hospital ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69189-0754_c1aac964-4e6f-4142-96f7-cffbb2f15c96 69189-0754 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20160602 ANDA ANDA203277 Avera McKennan Hospital LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 69189-0758_e30388ff-d862-45f4-95cd-06300679c48c 69189-0758 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20151110 ANDA ANDA074131 Avera McKennan Hospital PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 69189-0762_f5583ef3-aa1b-4444-8b87-8e637efaf571 69189-0762 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20160304 NDA NDA050662 Avera McKennan Hospital CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 69189-0793_332504dd-ff39-4c56-8b12-cb2a8b87e952 69189-0793 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20151119 ANDA ANDA091689 Avera McKennan Hospital RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 69189-0796_cb2a183b-037d-4dd3-bae1-03706a258540 69189-0796 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20160620 ANDA ANDA078597 Avera McKennan Hospital DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 69189-0797_8a7ef66e-af99-4c57-8b2c-5666c30f6d51 69189-0797 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20150609 ANDA ANDA078597 Avera McKennan Hospital DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 69189-0803_8d589436-8a52-4213-9b3f-3258d2ea9d50 69189-0803 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20150305 UNAPPROVED DRUG OTHER Avera McKennan Hospital PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 69189-0805_b3796ecd-35bb-464a-a452-3d605dc589a7 69189-0805 HUMAN PRESCRIPTION DRUG Rozerem ramelteon TABLET, FILM COATED ORAL 20150305 NDA NDA021782 Avera McKennan Hospital RAMELTEON 8 mg/1 Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] E 20171231 69189-0810_70d37227-dc6b-41fa-b68c-103babd6193d 69189-0810 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20150914 UNAPPROVED DRUG OTHER Avera McKennan Hospital PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 E 20171231 69189-0817_683c2a13-e3d9-4c7c-b5c0-d591232259bc 69189-0817 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150311 ANDA ANDA078703 Avera McKennan Hospital PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 69189-0818_656af5b3-cce2-4cdd-8d12-064a287c0f05 69189-0818 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150515 ANDA ANDA078703 Avera McKennan Hospital PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 69189-0819_af783987-2f2d-4cc7-9dbd-3532c6a60b20 69189-0819 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150302 ANDA ANDA078703 Avera McKennan Hospital PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 69189-0829_feea12d8-88b4-4208-a3cd-7330816b88cc 69189-0829 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20160929 ANDA ANDA074984 Avera McKennan Hospital DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 69189-0841_9b04facd-97eb-4e60-8ded-f4c97251427b 69189-0841 HUMAN PRESCRIPTION DRUG Protonix Delayed-Release PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20150921 NDA NDA020987 Avera McKennan Hospital PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] E 20171231 69189-0845_0cff8f2b-a304-43ea-ad0f-60241f564033 69189-0845 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160315 ANDA ANDA076467 Avera McKennan Hospital GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 69189-0852_e43b7d45-c55d-4bba-ae93-664d863f486a 69189-0852 HUMAN PRESCRIPTION DRUG VALPROIC ACID VALPROIC ACID CAPSULE, LIQUID FILLED ORAL 20150324 ANDA ANDA073484 Avera McKennan Hospital VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 69189-0853_9560ee91-2f7b-45ee-ab19-ad9f5eccb549 69189-0853 HUMAN OTC DRUG Leader ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20150904 ANDA ANDA076359 Avera McKennan Hospital IBUPROFEN 100 mg/1 E 20171231 69189-0860_d8862cb1-2128-4b16-9f90-b29e425cb43e 69189-0860 HUMAN OTC DRUG PlusPHARMA Simethicone TABLET, CHEWABLE ORAL 20160331 OTC MONOGRAPH FINAL part347 Avera McKennan Hospital DIMETHICONE 80 mg/1 N 20181231 69189-0863_0accc8ae-b5fd-42f9-a23a-69da8a843adf 69189-0863 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 20151009 ANDA ANDA074434 Avera McKennan Hospital CAPTOPRIL 12.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69189-0872_8f4d5c6a-782e-4aa3-a869-42de977f6899 69189-0872 HUMAN PRESCRIPTION DRUG FLUOXETINE fluoxetine hydrochloride CAPSULE ORAL 20150305 ANDA ANDA076922 Avera McKennan Hospital FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 69189-0881_94defa36-4c80-4983-b440-d3ccf39e9598 69189-0881 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide TABLET, FILM COATED ORAL 20150310 NDA NDA021169 Avera McKennan Hospital GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 69189-0883_e5f3df35-1006-4cd3-8387-9c7bcdebf4a6 69189-0883 HUMAN PRESCRIPTION DRUG galantamine hydrobromide galantamine hydrobromide TABLET, FILM COATED ORAL 20150902 NDA NDA021169 Avera McKennan Hospital GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 69189-0886_a41ac158-2794-4b45-87bb-d5b0566d857a 69189-0886 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20150714 ANDA ANDA040197 Avera McKennan Hospital ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 69189-0899_a993f31f-b4bb-4f4b-a18f-aa70adff75b8 69189-0899 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20151029 ANDA ANDA040197 Avera McKennan Hospital ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 69189-0904_ec870830-e978-4651-a6f5-32b8d64a3a21 69189-0904 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20150416 ANDA ANDA201190 Avera McKennan Hospital QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 69189-0908_229c5e3c-c630-46fc-9ac8-5fb1be41738e 69189-0908 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20150729 ANDA ANDA201190 Avera McKennan Hospital QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] E 20171231 69189-0910_9db057ff-6272-4b26-a49a-c3cb954cd82a 69189-0910 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151102 ANDA ANDA076467 Avera McKennan Hospital GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 69189-0918_eabbdd33-42f7-4ff4-8afd-97a361bf29ca 69189-0918 HUMAN PRESCRIPTION DRUG ULORIC febuxostat TABLET ORAL 20150302 NDA NDA021856 Avera McKennan Hospital FEBUXOSTAT 40 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 69189-0919_3af9db45-f8a0-4815-8e05-d8d7150dde40 69189-0919 HUMAN OTC DRUG cetirizine hydrochloride Cetirizine Hydrochloride TABLET ORAL 20160415 ANDA ANDA078336 Avera McKennan Hospital CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 69189-0921_f3a1c3bd-d46b-4fb6-9b24-8c41a10e1f7d 69189-0921 HUMAN OTC DRUG Regular Strength Enteric coated aspirin Aspirin TABLET, COATED ORAL 20150323 OTC MONOGRAPH FINAL part343 Avera McKennan Hospital ASPIRIN 325 mg/1 E 20171231 69189-0951_9635f3ae-10da-495e-9e8f-91875c8e677c 69189-0951 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, EXTENDED RELEASE ORAL 20150929 NDA NDA021999 Avera McKennan Hospital PALIPERIDONE 1.5 mg/1 Atypical Antipsychotic [EPC] E 20171231 69189-0952_c20788a5-5af5-47d2-bec3-f1579bac45c4 69189-0952 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, EXTENDED RELEASE ORAL 20150301 NDA NDA021999 Avera McKennan Hospital PALIPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 69189-0954_bcf220c6-61d3-4686-a0aa-6da00e2f9311 69189-0954 HUMAN PRESCRIPTION DRUG Dextroamphetamine Sulfate Dextroamphetamine Sulfate CAPSULE, EXTENDED RELEASE ORAL 20160510 ANDA ANDA076137 Avera McKennan Hospital DEXTROAMPHETAMINE SULFATE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 69189-0984_514fc039-2e1a-428d-92d1-7e793f864c94 69189-0984 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, COATED ORAL 20160222 ANDA ANDA077463 Avera McKennan Hospital NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 69189-1000_e1e8409c-cc16-4f8f-b6cf-f16996ed5469 69189-1000 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20160411 ANDA ANDA201190 Avera McKennan Hospital QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-1001_7a84d59a-37e3-4a15-b7b6-b066da25a059 69189-1001 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20150305 ANDA ANDA065093 Avera McKennan Hospital AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 69189-1049_478a8a32-e29f-409a-b1fb-9f1f0a34e8b0 69189-1049 HUMAN OTC DRUG calcium antacidextra strength extra strength Calcium carbonate TABLET, CHEWABLE ORAL 20150812 OTC MONOGRAPH FINAL part331 Avera McKennan Hospital CALCIUM CARBONATE 750 mg/1 E 20171231 69189-1060_35d2c008-10c8-4f1d-a10f-d54916c184af 69189-1060 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20160829 ANDA ANDA075429 Avera McKennan Hospital SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 69189-1078_c7d301c2-695e-4e97-8777-a538de3b16bd 69189-1078 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20150320 ANDA ANDA074052 Avera McKennan Hospital ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 69189-1094_3788f7ba-721b-4b06-8e5b-14a6c0cbf264 69189-1094 HUMAN OTC DRUG rugby all day relief Naproxen Sodium TABLET ORAL 20160303 ANDA ANDA074661 Avera McKennan Hospital NAPROXEN SODIUM 220 mg/1 N 20181231 69189-1105_0b821d66-ebcd-4c0f-9004-70e9568fa5a1 69189-1105 HUMAN PRESCRIPTION DRUG Premarin estrogens, conjugated TABLET, FILM COATED ORAL 20150803 NDA NDA004782 Avera McKennan Hospital ESTROGENS, CONJUGATED .9 mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient] E 20171231 69189-1107_77384e53-ea65-401b-bcd2-21a32efc889a 69189-1107 HUMAN PRESCRIPTION DRUG Prempro CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE TABLET, SUGAR COATED ORAL 20160128 NDA NDA020527 Avera McKennan Hospital ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE .625; 2.5 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [Chemical/Ingredient],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 69189-1110_d3bd1cc3-9dfe-49aa-8894-c7d4bcef8171 69189-1110 HUMAN PRESCRIPTION DRUG VIIBRYD vilazodone hydrochloride TABLET ORAL 20150303 NDA NDA022567 Avera McKennan Hospital VILAZODONE HYDROCHLORIDE 10 mg/1 E 20171231 69189-1147_c36c674a-b150-45df-8d1f-0dd257cacafc 69189-1147 HUMAN PRESCRIPTION DRUG Pacerone Amiodarone Hydrochloride TABLET ORAL 20150902 ANDA ANDA075135 Avera McKennan Hospital AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 69189-1173_81d4db98-a282-4839-8b94-76bcba78c3be 69189-1173 HUMAN PRESCRIPTION DRUG Captopril Captopril TABLET ORAL 20160205 ANDA ANDA074505 Avera McKennan Hospital CAPTOPRIL 50 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69189-1181_33ebd76a-800f-47c0-8230-1775ce3b43f4 69189-1181 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20150818 ANDA ANDA074501 Avera McKennan Hospital NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 69189-1201_ba8255c3-a4e3-4e8d-97bd-27c4b018c553 69189-1201 HUMAN PRESCRIPTION DRUG Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20151028 NDA NDA203100 Avera McKennan Hospital ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 150; 150; 200; 300 mg/1; mg/1; mg/1; mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 69189-1202_1edb6e03-3ec3-41b3-866c-ef5f41311c13 69189-1202 HUMAN PRESCRIPTION DRUG Linzess linaclotide CAPSULE, GELATIN COATED ORAL 20150604 NDA NDA202811 Avera McKennan Hospital LINACLOTIDE 145 ug/1 Guanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA] E 20171231 69189-1205_f8461362-e8ba-46a9-a3c4-af8178841971 69189-1205 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 20150330 ANDA ANDA064071 Avera McKennan Hospital PENICILLIN V POTASSIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 69189-1405_26b159ac-e9db-471b-a3cf-e05228e6d8be 69189-1405 HUMAN PRESCRIPTION DRUG Bystolic nebivolol hydrochloride TABLET ORAL 20150319 NDA NDA021742 Avera McKennan Hospital NEBIVOLOL HYDROCHLORIDE 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 69189-1430_622bcac8-26a7-4f51-96b7-c673b53a2c2e 69189-1430 HUMAN PRESCRIPTION DRUG Nicardipine Hydrochloride nicardipine hydrochloride CAPSULE ORAL 20150716 ANDA ANDA074642 Avera McKennan Hospital NICARDIPINE HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 69189-1438_9083f0c2-c1ed-4d18-97d3-db1c68a82859 69189-1438 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20160715 ANDA ANDA089586 Avera McKennan Hospital FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 69189-1452_77f3a538-9dbb-4469-ab41-d910b2d1311d 69189-1452 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20160516 ANDA ANDA074305 Avera McKennan Hospital GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 69189-1496_e0dfffde-9614-414c-9778-ec1abb4e95c0 69189-1496 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20150302 ANDA ANDA065211 Avera McKennan Hospital AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] E 20171231 69189-1516_91ad4baa-2d00-4604-a1c5-07daa8d7254e 69189-1516 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20151002 NDA AUTHORIZED GENERIC NDA020998 Avera McKennan Hospital CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 69189-1517_00e7572e-9343-43c5-96a1-9b922310f594 69189-1517 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150501 NDA AUTHORIZED GENERIC NDA020998 Avera McKennan Hospital CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 69189-1540_b1c8318b-0cb2-4d27-84bf-6fb664b4b77f 69189-1540 HUMAN PRESCRIPTION DRUG amlodipine besylate amlodipine besylate TABLET ORAL 20150721 NDA AUTHORIZED GENERIC NDA019787 Avera McKennan Hospital AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 69189-1596_c2749634-4ac3-4431-af23-2903dc24cff8 69189-1596 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET, FILM COATED ORAL 20150824 NDA NDA008316 Avera McKennan Hospital PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] N 20181231 69189-1620_0cc84c12-3b09-484a-870b-fb0135c5a406 69189-1620 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 20160711 ANDA ANDA040317 Avera McKennan Hospital DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 69189-1655_31e979a5-dfee-4613-8ff4-4b2371ef7706 69189-1655 HUMAN PRESCRIPTION DRUG Penicillin V Potasium Penicillin V Potasium TABLET ORAL 20150526 ANDA ANDA064071 Avera McKennan Hospital PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 69189-1695_17173b20-bd2b-480b-adfd-83599ad5eabd 69189-1695 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20150415 ANDA ANDA089367 Avera McKennan Hospital ISOSORBIDE DINITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 69189-1704_37ae8d40-9d16-4d52-ab57-49ea81dfd02a 69189-1704 HUMAN PRESCRIPTION DRUG Mephyton phytonadione TABLET ORAL 20150309 NDA NDA010104 Avera McKennan Hospital PHYTONADIONE 5 mg/1 Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] E 20171231 69189-1708_68c120d7-c4d9-4228-bc8d-e237fafab88d 69189-1708 HUMAN PRESCRIPTION DRUG Prometrium Progesterone CAPSULE ORAL 20150811 NDA NDA019781 Avera McKennan Hospital PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 69189-1710_a3120db7-a7da-4b18-a1cf-d2f7d1129fa2 69189-1710 HUMAN PRESCRIPTION DRUG Eplerenone EPLERENONE TABLET, FILM COATED ORAL 20150617 NDA AUTHORIZED GENERIC NDA021437 Avera McKennan Hospital EPLERENONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 69189-1790_e6b706fc-7c90-4afb-adf8-eb35b69e094b 69189-1790 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20160719 ANDA ANDA089741 Avera McKennan Hospital FLUPHENAZINE HYDROCHLORIDE 2.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 69189-1840_2bd42d31-52de-40dc-958a-441c96ba3734 69189-1840 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20150403 ANDA ANDA202556 Avera McKennan Hospital HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 69189-1874_4393cdc8-bfba-4f44-9d76-40a7009e082c 69189-1874 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20150323 ANDA ANDA065189 Avera McKennan Hospital AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] E 20171231 69189-1961_117792e8-c204-4669-9d65-c46c595c1faf 69189-1961 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20150501 ANDA ANDA065144 Avera McKennan Hospital CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 69189-1962_3542f1e5-297f-4cef-80cf-79bb2c87e071 69189-1962 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20150302 ANDA ANDA065136 Avera McKennan Hospital CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 69189-1970_349c3fe2-8a8c-431d-a465-5c72a7ebb940 69189-1970 HUMAN PRESCRIPTION DRUG MOVANTIK naloxegol oxalate TABLET, FILM COATED ORAL 20160322 NDA NDA204760 Avera McKennan Hospital NALOXEGOL OXALATE 25 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 69189-1973_ee2e2460-153a-4f0d-b264-bfe85406ba4a 69189-1973 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20151028 ANDA ANDA072101 Avera McKennan Hospital DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69189-2003_b9538029-9024-43e2-9ca8-35587b95ba10 69189-2003 HUMAN PRESCRIPTION DRUG Ziprasidone ziprasidone hydrochloride CAPSULE ORAL 20160209 NDA AUTHORIZED GENERIC NDA020825 Avera McKennan Hospital ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-2011_3c564144-d92b-4928-a517-f9974deff752 69189-2011 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE ORAL 20160211 ANDA ANDA040368 Avera McKennan Hospital ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 69189-2015_92137232-afa9-4b29-a40f-67ad377a5579 69189-2015 HUMAN OTC DRUG Tri-Buffered Aspirin Aspirin TABLET, FILM COATED ORAL 20150604 OTC MONOGRAPH NOT FINAL part343 Avera McKennan Hospital ASPIRIN 325 mg/1 N 20181231 69189-2020_6ee8d49d-cb9f-4158-874a-543d20bda7af 69189-2020 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20150318 ANDA ANDA064076 Avera McKennan Hospital AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 69189-2027_01f762e8-99a9-4e21-903a-b57ae98bba8f 69189-2027 HUMAN PRESCRIPTION DRUG Clomipramine Hydrochloride Clomipramine Hydrochloride CAPSULE ORAL 20150812 ANDA ANDA074364 Avera McKennan Hospital CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69189-2043_1d26faaa-cb04-4cc3-9da9-7b414ba2e57d 69189-2043 HUMAN PRESCRIPTION DRUG Ribavirin Ribavirin CAPSULE ORAL 20151026 ANDA ANDA076192 Avera McKennan Hospital RIBAVIRIN 200 mg/1 Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 69189-2051_8c087f7e-dc26-40d7-96ab-368c9f5f942c 69189-2051 HUMAN OTC DRUG Driminate Dimenhydrinate TABLET ORAL 20150427 OTC MONOGRAPH FINAL part336 Avera McKennan Hospital DIMENHYDRINATE 50 mg/1 E 20171231 69189-2063_567ac445-1f9c-4e11-bcf2-46832ef7f213 69189-2063 HUMAN PRESCRIPTION DRUG Atenolol and Chlorthalidone atenolol and chlorthalidone TABLET ORAL 20160516 ANDA ANDA074203 Avera McKennan Hospital ATENOLOL; CHLORTHALIDONE 50; 25 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 69189-2176_dc2990dc-b6a6-478b-bfc7-e35e9357a3cd 69189-2176 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20150227 ANDA ANDA065330 Avera McKennan Hospital CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 69189-2213_fd878a20-9788-4ef0-9382-9647310ca475 69189-2213 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20150323 ANDA ANDA040218 Avera McKennan Hospital AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 69189-2217_d1d099e8-49c4-45ff-9a50-e4cfb6a376fc 69189-2217 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20150727 ANDA ANDA040218 Avera McKennan Hospital AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69189-2241_85cf0495-53a6-44be-92cb-753d815e9f0f 69189-2241 HUMAN PRESCRIPTION DRUG Fetzima LEVOMILNACIPRAN HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20150309 NDA NDA204168 Avera McKennan Hospital LEVOMILNACIPRAN HYDROCHLORIDE 40 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 69189-2248_6a092d32-6058-467b-9ae2-d4ac9db7838f 69189-2248 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20151001 ANDA ANDA061454 Avera McKennan Hospital DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 69189-2348_bed42828-541f-4754-9e5f-bb5a8541a3d9 69189-2348 HUMAN PRESCRIPTION DRUG Propylthiouracil Propylthiouracil TABLET ORAL 20150303 ANDA ANDA080172 Avera McKennan Hospital PROPYLTHIOURACIL 50 mg/1 Thyroid Hormone Synthesis Inhibitor [EPC],Thyroid Hormone Synthesis Inhibitors [MoA] N 20181231 69189-2367_a91262ca-94dd-47db-8481-6c94057a6812 69189-2367 HUMAN PRESCRIPTION DRUG Raloxifene Raloxifene hydrochloride TABLET, FILM COATED ORAL 20160509 ANDA ANDA200825 Avera McKennan Hospital RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 69189-2537_8bbad053-bca3-4016-bef5-bde7240d326f 69189-2537 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide triamterene and hydrochlorothiazide CAPSULE ORAL 20150402 ANDA ANDA074701 Avera McKennan Hospital HYDROCHLOROTHIAZIDE; TRIAMTERENE 25; 37.5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC] E 20171231 69189-2538_c975e014-8c92-4419-a4a7-3568889f4f2e 69189-2538 HUMAN PRESCRIPTION DRUG Carbidopa and levodopa Carbidopa and levodopa TABLET ORAL 20160706 ANDA ANDA074260 Avera McKennan Hospital CARBIDOPA; LEVODOPA 10; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 69189-2544_1e9f1aa4-29b0-472b-8be7-108142e7913f 69189-2544 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20150313 ANDA ANDA040511 Avera McKennan Hospital BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 69189-2601_63b2acf2-7932-4c94-8b6f-1317948256de 69189-2601 HUMAN PRESCRIPTION DRUG Myrbetriq mirabegron TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150323 NDA NDA202611 Avera McKennan Hospital MIRABEGRON 25 mg/1 beta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 69189-2613_20308ab9-d3c2-489c-95a4-9f771a74ce31 69189-2613 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20150309 ANDA ANDA064076 Avera McKennan Hospital AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] E 20171231 69189-2620_2f678c5d-444e-4bb3-875a-d731defbdd30 69189-2620 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET ORAL 20160111 ANDA ANDA075037 Avera McKennan Hospital ISOSORBIDE MONONITRATE 20 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 69189-2685_a84b2038-f235-44be-9e1e-8665973ac05a 69189-2685 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Extended-Release dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20151201 NDA AUTHORIZED GENERIC NDA021802 Avera McKennan Hospital DEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 69189-2715_cfe7c9b2-4a73-4bce-b058-5ed84959c9ae 69189-2715 HUMAN PRESCRIPTION DRUG methylphenidate hydrochloride methylphenidate hydrochloride TABLET ORAL 20151104 NDA AUTHORIZED GENERIC NDA021121 Avera McKennan Hospital METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 69189-2810_01a25c18-dcd9-48d2-bb41-451319a4a3f3 69189-2810 HUMAN PRESCRIPTION DRUG Oxazepam Oxazepam CAPSULE ORAL 20160310 ANDA ANDA071756 Avera McKennan Hospital OXAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 69189-2824_b12818c3-4c9e-4c72-aa24-161f6698e04c 69189-2824 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20160818 ANDA ANDA075049 Avera McKennan Hospital FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69189-2850_6976b0e9-d8d6-4137-9661-19a16ab74548 69189-2850 HUMAN PRESCRIPTION DRUG guanfacine guanfacine TABLET, EXTENDED RELEASE ORAL 20150421 ANDA ANDA200881 Avera McKennan Hospital GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 69189-2921_aaaf207f-0fec-459a-84d7-d7ee8af86dc3 69189-2921 HUMAN PRESCRIPTION DRUG Telmisartan telmisartan TABLET ORAL 20150415 ANDA ANDA202397 Avera McKennan Hospital TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 69189-2983_7bd41f7a-224a-47e0-8c5f-3e3ed61fa251 69189-2983 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20150402 ANDA ANDA201447 Avera McKennan Hospital OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 69189-3123_5e38dae9-7cfc-4d86-841b-613c09ad67b5 69189-3123 HUMAN PRESCRIPTION DRUG Repaglinide repaglinide TABLET ORAL 20160122 ANDA ANDA090252 Avera McKennan Hospital REPAGLINIDE 2 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 69189-3124_3c41c3d4-6eae-4239-ac76-2cd85c6296a4 69189-3124 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20160614 ANDA ANDA062286 Avera McKennan Hospital DICLOXACILLIN SODIUM 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 69189-3125_74384159-a199-4d68-b532-d605ba0dd36b 69189-3125 HUMAN PRESCRIPTION DRUG Dicloxacillin Sodium Dicloxacillin Sodium CAPSULE ORAL 20160128 ANDA ANDA062286 Avera McKennan Hospital DICLOXACILLIN SODIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 69189-3147_5570e7e9-8b94-4ece-84d5-fbfe525cb861 69189-3147 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20150309 ANDA ANDA062702 Avera McKennan Hospital CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 69189-3167_8a536762-2156-4066-a5f9-7ae0805c4658 69189-3167 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20160628 ANDA ANDA063009 Avera McKennan Hospital MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 69189-3180_db1f11bc-7370-475e-a674-ce0c9bb079c6 69189-3180 HUMAN PRESCRIPTION DRUG Glycopyrrolate glycopyrrolate TABLET ORAL 20150305 ANDA ANDA040821 Avera McKennan Hospital GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 69189-3193_a88c1e4f-5e35-4102-b086-4bf27438576e 69189-3193 HUMAN PRESCRIPTION DRUG Ketoprofen Ketoprofen CAPSULE ORAL 20151028 ANDA ANDA073516 Avera McKennan Hospital KETOPROFEN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69189-3227_f2937fe4-f2cb-4677-ad3d-2a57be819a88 69189-3227 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20150302 NDA NDA021411 Avera McKennan Hospital ATOMOXETINE HYDROCHLORIDE 10 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] E 20171231 69189-3228_29b957db-0b7b-4072-a838-75ace226e054 69189-3228 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20150305 NDA NDA021411 Avera McKennan Hospital ATOMOXETINE HYDROCHLORIDE 25 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] E 20171231 69189-3229_d415f6a3-c2b7-4ded-b1eb-b2754626570e 69189-3229 HUMAN PRESCRIPTION DRUG Strattera Atomoxetine hydrochloride CAPSULE ORAL 20150323 NDA NDA021411 Avera McKennan Hospital ATOMOXETINE HYDROCHLORIDE 40 mg/1 Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA] E 20171231 69189-3320_947a8009-fce7-436b-b231-c6bc66bc0566 69189-3320 HUMAN PRESCRIPTION DRUG HYDROCORTISONE hydrocortisone TABLET ORAL 20150722 ANDA ANDA040646 Avera McKennan Hospital HYDROCORTISONE 10 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 69189-3335_080f8095-70be-4af5-bac0-4927b0502ddb 69189-3335 HUMAN PRESCRIPTION DRUG Norvir Ritonavir TABLET, FILM COATED ORAL 20160314 NDA NDA022417 Avera McKennan Hospital RITONAVIR 100 mg/1 UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 69189-3404_ef6cc179-461f-4912-b216-adf80bd787fa 69189-3404 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20160113 ANDA ANDA201486 Avera McKennan Hospital TOLTERODINE TARTRATE 4 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 69189-3407_c866e389-4fb4-4637-95e8-beac10e6fb44 69189-3407 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150316 NDA NDA022525 Avera McKennan Hospital MEMANTINE HYDROCHLORIDE 7 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 69189-3414_d5510d11-dc3d-4358-8985-91ce2f51646d 69189-3414 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150311 NDA NDA022525 Avera McKennan Hospital MEMANTINE HYDROCHLORIDE 14 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 69189-3422_bcd77094-2b92-4a2d-b45b-0d68cc6f2d99 69189-3422 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/Macrocrystals Nitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline CAPSULE ORAL 20150303 ANDA ANDA076648 Avera McKennan Hospital NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 69189-3428_cfa35ed1-a5ca-4dd3-9df5-67507059c321 69189-3428 HUMAN PRESCRIPTION DRUG Namenda XR memantine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150302 NDA NDA022525 Avera McKennan Hospital MEMANTINE HYDROCHLORIDE 28 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] E 20171231 69189-3624_0af99050-1afd-4159-a51c-660897d575db 69189-3624 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20150428 NDA NDA021567 Avera McKennan Hospital ATAZANAVIR SULFATE 150 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 69189-3631_48d06234-3489-471f-92b6-051f67e0a3c2 69189-3631 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20150803 NDA NDA021567 Avera McKennan Hospital ATAZANAVIR SULFATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 69189-3635_7e4411ea-9788-4336-a76a-35694cc4c19a 69189-3635 HUMAN OTC DRUG Cetirizine Hydrochloride cetirizine hydrochloride TABLET, FILM COATED ORAL 20150529 ANDA ANDA076677 Avera McKennan Hospital CETIRIZINE HYDROCHLORIDE 5 mg/1 E 20171231 69189-3658_bbd38826-2b36-4f08-8708-6a52fb267716 69189-3658 HUMAN PRESCRIPTION DRUG Nitrofurantoin monohydrate macrocrystals Nitrofurantoin monohydrate macrocrystals CAPSULE ORAL 20160328 ANDA ANDA202250 Avera McKennan Hospital NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 69189-3727_89b561d5-3325-4a25-8c76-412ea2f3210a 69189-3727 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20150310 NDA NDA021402 Avera McKennan Hospital LEVOTHYROXINE SODIUM 137 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 69189-3740_8e565f0a-ed52-46f9-9638-88a41edbf6b2 69189-3740 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate TABLET ORAL 20160202 NDA AUTHORIZED GENERIC NDA011839 Avera McKennan Hospital MEDROXYPROGESTERONE ACETATE 2.5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 69189-3741_104ff505-be2a-4686-8bc5-363c883e2543 69189-3741 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate MEDROXYPROGESTERONE ACETATE TABLET ORAL 20150430 NDA AUTHORIZED GENERIC NDA011839 Avera McKennan Hospital MEDROXYPROGESTERONE ACETATE 5 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] E 20171231 69189-3742_1a2b8914-4ff8-4e63-9713-6012d9bd8f49 69189-3742 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20150914 ANDA ANDA084349 Avera McKennan Hospital PHENYTOIN SODIUM 30 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 69189-3855_8373c564-55f3-4492-ac18-38c0562a2e99 69189-3855 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20160628 NDA NDA021323 Avera McKennan Hospital ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69189-3951_73ab270d-83cb-4706-8c50-e57ea7e4572a 69189-3951 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20150305 ANDA ANDA091226 Avera McKennan Hospital ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 69189-3952_25409491-73f8-417f-9b9b-9459a7e38ab0 69189-3952 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20150302 ANDA ANDA091226 Avera McKennan Hospital ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 69189-4022_884c9c78-638c-4989-acb5-98526879767b 69189-4022 HUMAN PRESCRIPTION DRUG Acetazolamide Acetazolamide TABLET ORAL 20150720 ANDA ANDA040195 Avera McKennan Hospital ACETAZOLAMIDE 125 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] E 20171231 69189-4026_15358c08-917e-4724-8bf4-27ec6e2c0309 69189-4026 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 20151105 ANDA ANDA075319 Avera McKennan Hospital KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 69189-4040_27170634-3cae-4260-84f9-32db57281810 69189-4040 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 20161025 OTC MONOGRAPH NOT FINAL part343 Avera McKennan Hospital ASPIRIN 81 mg/1 N 20181231 69189-4093_7b50d848-8a12-4743-9c9a-0d9f6dc0e7cb 69189-4093 HUMAN PRESCRIPTION DRUG Ropinirole Hydrochloride ropinirole hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150309 ANDA ANDA200462 Avera McKennan Hospital ROPINIROLE HYDROCHLORIDE 8 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 69189-4097_ab7c3a5d-5e03-4656-aa1c-1c7732696e3e 69189-4097 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20150331 ANDA ANDA072235 Avera McKennan Hospital BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 69189-4105_8e0a7aa7-c788-456b-a70b-c7aaabf2b23b 69189-4105 HUMAN PRESCRIPTION DRUG Abacavir Sulfate abacavir sulfate TABLET, FILM COATED ORAL 20151023 ANDA ANDA091294 Avera McKennan Hospital ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 69189-4124_6667b83f-efc7-41ff-b6c0-061b7146b2e1 69189-4124 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20150527 ANDA ANDA078115 Avera McKennan Hospital CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 69189-4138_f1cc9f80-8b9c-42df-8c2e-366c796a79b1 69189-4138 HUMAN PRESCRIPTION DRUG Granisetron Hydrochloride Granisetron Hydrochloride TABLET, FILM COATED ORAL 20150302 ANDA ANDA090817 Avera McKennan Hospital GRANISETRON HYDROCHLORIDE 1 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 69189-4186_f254c7e0-2b5c-462c-8e92-8f69d88f66ca 69189-4186 HUMAN PRESCRIPTION DRUG Dexamethasone Dexamethasone TABLET ORAL 20160622 ANDA ANDA088316 Avera McKennan Hospital DEXAMETHASONE 6 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69189-4233_1504df82-1c9b-4276-a6ff-acbd0f1adad1 69189-4233 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20150326 ANDA ANDA074225 Avera McKennan Hospital BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 69189-4234_1c3d961c-5476-45fd-aacf-854f211d28b1 69189-4234 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20150313 ANDA ANDA074225 Avera McKennan Hospital BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 69189-4276_96796d17-6a2d-4e47-8be3-4441f6b2b149 69189-4276 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20150316 ANDA ANDA078518 Avera McKennan Hospital VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 69189-4341_a1d21cf7-cebf-41ef-ac2e-22fdeee58127 69189-4341 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20150309 NDA NDA021402 Avera McKennan Hospital LEVOTHYROXINE SODIUM 25 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 69189-4411_9461030e-d95a-47e2-88f3-ee9487ddf16d 69189-4411 HUMAN PRESCRIPTION DRUG Dantrolene Sodium Dantrolene Sodium CAPSULE ORAL 20160913 ANDA ANDA076856 Avera McKennan Hospital DANTROLENE SODIUM 25 mg/1 Decreased Striated Muscle Contraction [PE],Decreased Striated Muscle Tone [PE],Skeletal Muscle Relaxant [EPC] N 20181231 69189-4416_4b856cc1-20cb-40e8-99dc-68fff029c8ee 69189-4416 HUMAN PRESCRIPTION DRUG metformin hydrochloride metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20161017 ANDA ANDA076873 Avera McKennan Hospital METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 69189-4485_19758408-bf8e-4771-a2a9-86eb6eab174b 69189-4485 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20150930 ANDA ANDA040489 Avera McKennan Hospital METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 69189-4581_0c88e81e-20fd-4f09-9dd7-93a904eb1b6b 69189-4581 HUMAN PRESCRIPTION DRUG Mercaptopurine Mercaptopurine TABLET ORAL 20150301 ANDA ANDA040528 Avera McKennan Hospital MERCAPTOPURINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] E 20171231 69189-4593_e0f77279-9639-4830-b3f4-56a86023ccb5 69189-4593 HUMAN PRESCRIPTION DRUG MethylPREDNISolone methylprednisolone TABLET ORAL 20150710 ANDA ANDA040183 Avera McKennan Hospital METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69189-5000_b66ade07-bdf7-43d9-89f2-dd9d0d065eaf 69189-5000 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20150317 NDA AUTHORIZED GENERIC NDA007073 Avera McKennan Hospital SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] E 20171231 69189-5016_addc5593-3e50-4600-914e-9ba6e12d0592 69189-5016 HUMAN PRESCRIPTION DRUG Fluconazole fluconazole TABLET ORAL 20160204 NDA AUTHORIZED GENERIC NDA019949 Avera McKennan Hospital FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 69189-5020_fabca9e8-5898-4893-ad63-e1320c3129aa 69189-5020 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20150406 NDA NDA021153 Avera McKennan Hospital ESOMEPRAZOLE MAGNESIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 69189-5040_b296899b-82d1-4983-a9a1-0c215c8d901e 69189-5040 HUMAN PRESCRIPTION DRUG NEXIUM Esomeprazole magnesium CAPSULE, DELAYED RELEASE ORAL 20150331 NDA NDA021153 Avera McKennan Hospital ESOMEPRAZOLE MAGNESIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 69189-5110_bae90ccf-5668-4507-9c87-fccd8d33fd1b 69189-5110 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20150908 ANDA ANDA040185 Avera McKennan Hospital PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 69189-5135_139fc3b0-ecea-4e64-b71d-f74e721e8dd9 69189-5135 HUMAN OTC DRUG Pain Reliever Plus Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 20150414 OTC MONOGRAPH NOT FINAL part343 Avera McKennan Hospital ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 E 20171231 69189-5140_98dc7a8f-df68-4239-819a-2be020bebff7 69189-5140 HUMAN PRESCRIPTION DRUG Alendronate Sodium Alendronate Sodium TABLET ORAL 20150408 ANDA ANDA075710 Avera McKennan Hospital ALENDRONATE SODIUM 5 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 69189-5187_7c722718-fbc3-4a19-8fd3-817f8c53d1b1 69189-5187 HUMAN PRESCRIPTION DRUG CARBIDOPA AND LEVODOPA CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING ORAL 20150424 ANDA ANDA078690 Avera McKennan Hospital CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] N 20181231 69189-5190_7a741f41-ad7c-425b-b0a7-af78e490b4d5 69189-5190 HUMAN PRESCRIPTION DRUG Detrol LA tolterodine tartrate CAPSULE, EXTENDED RELEASE ORAL 20160316 NDA NDA021228 Avera McKennan Hospital TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 69189-5206_b1cfd530-dfa5-4336-90b1-0b1ece108817 69189-5206 HUMAN PRESCRIPTION DRUG OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE ORAL 20161014 ANDA ANDA076745 Avera McKennan Hospital OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 69189-5218_5ce5600e-8fd0-439e-bb3e-ea3e19ae8892 69189-5218 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine Hydrochloride TABLET, FILM COATED ORAL 20160215 ANDA ANDA072099 Avera McKennan Hospital DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69189-5241_6664d6f6-5932-4eaf-982b-7dd94a6638c7 69189-5241 HUMAN PRESCRIPTION DRUG Anagrelide Hydrochloride Anagrelide Hydrochloride CAPSULE ORAL 20150715 ANDA ANDA076468 Avera McKennan Hospital ANAGRELIDE HYDROCHLORIDE .5 mg/1 Decreased Platelet Production [PE],Platelet-reducing Agent [EPC],Phosphodiesterase 3 Inhibitors [MoA] E 20171231 69189-5270_694ae160-2912-4ed4-a391-a41398889083 69189-5270 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20160106 ANDA ANDA091151 Avera McKennan Hospital ESZOPICLONE 1 mg/1 CIV N 20181231 69189-5271_eff332e3-3f8d-4ac8-b32e-0dce9166aceb 69189-5271 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20160620 ANDA ANDA091151 Avera McKennan Hospital ESZOPICLONE 2 mg/1 CIV N 20181231 69189-5272_9427c449-0501-41b2-82e7-9f75c3de1077 69189-5272 HUMAN PRESCRIPTION DRUG Eszopiclone eszopiclone TABLET, FILM COATED ORAL 20161019 ANDA ANDA091151 Avera McKennan Hospital ESZOPICLONE 3 mg/1 CIV N 20181231 69189-5276_d0d7e287-129a-4e34-9562-5f21fe805e83 69189-5276 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride TABLET ORAL 20150429 ANDA ANDA077107 Avera McKennan Hospital DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 69189-5305_f3a1d452-38fc-46a3-913f-5682119c8e50 69189-5305 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20160129 ANDA ANDA076578 Avera McKennan Hospital ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 69189-5365_672d1e3a-4069-4f88-9b2a-8a253b65973f 69189-5365 HUMAN OTC DRUG Acid Gone Antacid Extra Strength aluminum hydroxide and magnesium carbonate TABLET, CHEWABLE ORAL 20150709 OTC MONOGRAPH FINAL part331 Avera McKennan Hospital ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 N 20181231 69189-5371_409ec663-7146-431c-85db-24ea239d6487 69189-5371 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20150327 ANDA ANDA071403 Avera McKennan Hospital LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 69189-5375_0c89b207-eb23-496a-901c-7fcdde97d811 69189-5375 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride doxepin hydrochloride CAPSULE ORAL 20150518 ANDA ANDA070791 Avera McKennan Hospital DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69189-5400_9b8b0d5a-b6e3-43f5-a50c-191f65461d03 69189-5400 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20160415 ANDA ANDA075994 Avera McKennan Hospital LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 69189-5402_6790b6a0-fc1a-4ce9-b4c8-68e578bc8b91 69189-5402 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20161018 ANDA ANDA079171 Avera McKennan Hospital ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69189-5420_77779e57-ade7-4113-82c2-f1884828c5da 69189-5420 HUMAN PRESCRIPTION DRUG Cabergoline Cabergoline TABLET ORAL 20150414 ANDA ANDA077750 Avera McKennan Hospital CABERGOLINE .5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] E 20171231 69189-5421_470061f7-de45-4f83-8f30-4c6169dbf2dd 69189-5421 HUMAN PRESCRIPTION DRUG Pioglitazone pioglitazone TABLET ORAL 20160215 ANDA ANDA078670 Avera McKennan Hospital PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 69189-5510_907e7145-83e7-4103-a084-a24efbf4a756 69189-5510 HUMAN PRESCRIPTION DRUG Olanzapine olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20150902 ANDA ANDA202285 Avera McKennan Hospital OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] E 20171231 69189-5529_55ac8e01-79f9-4cea-b11f-96842293976d 69189-5529 HUMAN OTC DRUG heartburn relief original strength Famotidine TABLET ORAL 20150306 ANDA ANDA075400 Avera McKennan Hospital FAMOTIDINE 10 mg/1 N 20181231 69189-5550_f5e34fa1-2754-4858-a213-b182128bc3ba 69189-5550 HUMAN PRESCRIPTION DRUG Dexmethylphenidate Hydrochloride Dexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150306 ANDA ANDA078908 Avera McKennan Hospital DEXMETHYLPHENIDATE HYDROCHLORIDE 5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII E 20171231 69189-5554_6a95b9fc-104a-40ad-a0fd-60f8160fa062 69189-5554 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20151102 ANDA ANDA070175 Avera McKennan Hospital PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 69189-5557_ac1f18e1-8c68-412e-871b-b77af5f4e27a 69189-5557 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20160307 ANDA ANDA070178 Avera McKennan Hospital PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 69189-5710_6c1ee256-a2b2-4de9-b102-130dadcab179 69189-5710 HUMAN OTC DRUG fexofenadine hydrochloride fexofenadine hydrochloride TABLET, FILM COATED ORAL 20150313 ANDA ANDA076447 Avera McKennan Hospital FEXOFENADINE HYDROCHLORIDE 180 mg/1 E 20171231 69189-5728_e6fc3696-eed8-40e8-abc2-32b615ecc70c 69189-5728 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20150301 ANDA ANDA075511 Avera McKennan Hospital FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 69189-5784_7cb74a35-1977-4981-a1dc-0cc7093b324b 69189-5784 HUMAN OTC DRUG Mapap Sinus Congestion and Pain Maximum Strength Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20150603 OTC MONOGRAPH FINAL part341 Avera McKennan Hospital ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 69189-5800_e5f28d83-d575-4c10-af66-84c5535f98f7 69189-5800 HUMAN PRESCRIPTION DRUG Tikosyn dofetilide CAPSULE ORAL 20160628 NDA NDA020931 Avera McKennan Hospital DOFETILIDE .125 mg/1 Antiarrhythmic [EPC] N 20181231 69189-5810_bfb83f6b-8256-4ea0-84db-dc093b7b8139 69189-5810 HUMAN PRESCRIPTION DRUG Tikosyn dofetilide CAPSULE ORAL 20160729 NDA NDA020931 Avera McKennan Hospital DOFETILIDE .25 mg/1 Antiarrhythmic [EPC] N 20181231 69189-5820_7c329776-808b-4c94-a77b-3c0d403917b6 69189-5820 HUMAN PRESCRIPTION DRUG Tikosyn dofetilide CAPSULE ORAL 20160328 NDA NDA020931 Avera McKennan Hospital DOFETILIDE .5 mg/1 Antiarrhythmic [EPC] N 20181231 69189-5850_0c1a5a46-4a45-4ffe-a426-746123d23bea 69189-5850 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20150316 ANDA ANDA076765 Avera McKennan Hospital ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 69189-5851_3a4834c6-9ef0-438d-8c20-bf08ae50e4a5 69189-5851 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20150301 ANDA ANDA076765 Avera McKennan Hospital ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 69189-5904_6b789eb5-a7a6-4a60-9642-9b22bef8712c 69189-5904 HUMAN OTC DRUG SENEXON SENNA TABLET, COATED ORAL 20151102 OTC MONOGRAPH NOT FINAL part334 Avera McKennan Hospital SENNOSIDES A AND B 8.6 mg/1 E 20171231 69189-5937_b377e079-6d5c-4a9d-afdf-370fcb921104 69189-5937 HUMAN PRESCRIPTION DRUG Candesartan cilexetil Candesartan cilexetil TABLET ORAL 20150813 ANDA ANDA078702 Avera McKennan Hospital CANDESARTAN CILEXETIL 8 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 69189-6120_744c71af-0855-4def-8211-60003271e150 69189-6120 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150416 ANDA ANDA074910 Avera McKennan Hospital DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 69189-6201_ebbc88dd-ed9c-4128-8ffd-d8501b09433f 69189-6201 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150625 ANDA ANDA078306 Avera McKennan Hospital VERAPAMIL HYDROCHLORIDE 100 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 69189-6231_4cc65c1f-5762-44ec-bec8-0129ec4144f9 69189-6231 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20150304 ANDA ANDA077042 Avera McKennan Hospital CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 69189-6232_79ede4e0-6d28-423b-94b6-2384ca124cf9 69189-6232 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20160127 ANDA ANDA077042 Avera McKennan Hospital CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 69189-6434_237811e7-8544-4e5c-bde1-5d441ee22e07 69189-6434 HUMAN OTC DRUG SENNA SENNA TABLET, COATED ORAL 20150903 OTC MONOGRAPH NOT FINAL part334 Avera McKennan Hospital SENNOSIDES A AND B 8.6 mg/1 E 20171231 69189-6594_16f87470-4c15-4f73-ac48-d5d8a9157c81 69189-6594 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20150317 NDA NDA021402 Avera McKennan Hospital LEVOTHYROXINE SODIUM 88 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 69189-6605_f0dac68c-e4c0-4857-bbff-83ff9ae73520 69189-6605 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150310 ANDA ANDA076702 Avera McKennan Hospital OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 69189-6610_db94d638-3907-4f86-b1f5-f93dec24cf45 69189-6610 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150323 ANDA ANDA076644 Avera McKennan Hospital OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 69189-7008_f5e7d1e9-ad48-4797-b47c-002e04459521 69189-7008 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20160118 ANDA ANDA076762 Avera McKennan Hospital LOXAPINE SUCCINATE 5 mg/1 N 20181231 69189-7010_378582bf-263f-4dfb-b130-9e5158647b86 69189-7010 HUMAN PRESCRIPTION DRUG Welchol colesevelam hydrochloride TABLET, FILM COATED ORAL 20150304 NDA NDA021176 Avera McKennan Hospital COLESEVELAM HYDROCHLORIDE 625 mg/1 Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 69189-7025_4985107c-8183-4974-95f9-d12161d8e398 69189-7025 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20150602 ANDA ANDA076762 Avera McKennan Hospital LOXAPINE SUCCINATE 25 mg/1 N 20181231 69189-7068_c7a739c0-825e-4e1c-ae1f-6f0b9af4fbe7 69189-7068 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20160126 NDA NDA021402 Avera McKennan Hospital LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20181231 69189-7069_9488f436-ff19-4585-9979-bdc6a209ce2a 69189-7069 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20150911 NDA NDA021402 Avera McKennan Hospital LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 69189-7070_84bd1b92-28f0-4fe7-af3a-80101d54b62a 69189-7070 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20150403 NDA NDA021402 Avera McKennan Hospital LEVOTHYROXINE SODIUM 175 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 69189-7096_4788a11a-742f-423b-b381-b62f57b371a8 69189-7096 HUMAN PRESCRIPTION DRUG Bromocriptine Mesylate bromocriptine mesylate CAPSULE ORAL 20160308 ANDA ANDA077226 Avera McKennan Hospital BROMOCRIPTINE MESYLATE 5 mg/1 Ergolines [Chemical/Ingredient],Ergot Derivative [EPC] N 20181231 69189-7295_c1699662-ff9a-4aa8-9b5f-934c1c909d60 69189-7295 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20151019 ANDA ANDA076373 Avera McKennan Hospital CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 69189-7352_4738c249-ee2a-42c2-a3aa-cbf584f6ef99 69189-7352 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20160707 ANDA ANDA202395 Avera McKennan Hospital ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-7353_7987d4ca-465c-4c44-940c-4c71be433279 69189-7353 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20160718 ANDA ANDA202395 Avera McKennan Hospital ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 69189-7354_cf3ef681-a475-4dcd-8b7c-52d0c79b6bf9 69189-7354 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20161020 ANDA ANDA075765 Avera McKennan Hospital CALCITRIOL .5 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 69189-7365_5f397781-a6b3-442a-a2a1-5e14841aca12 69189-7365 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20150311 ANDA ANDA076958 Avera McKennan Hospital LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 69189-7367_04480b4e-5bf8-4687-bbf2-df6698ec001d 69189-7367 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20150512 ANDA ANDA077157 Avera McKennan Hospital LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 69189-7432_a76680d0-7bec-4166-8fcc-6c28d02beff6 69189-7432 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150520 ANDA ANDA077530 Avera McKennan Hospital VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 69189-7620_647a695c-4f3d-4450-a345-091b6911698a 69189-7620 HUMAN PRESCRIPTION DRUG Letrozole Letrozole TABLET, FILM COATED ORAL 20160217 ANDA ANDA090289 Avera McKennan Hospital LETROZOLE 2.5 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 69189-7638_f9a248c1-267c-4ff0-b8da-df66e3f0c133 69189-7638 HUMAN PRESCRIPTION DRUG Temozolomide Temozolomide CAPSULE ORAL 20150611 ANDA ANDA078879 Avera McKennan Hospital TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] E 20171231 69189-7732_65740b0a-0be4-490b-9796-6614087a7e60 69189-7732 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20160304 ANDA ANDA078139 Avera McKennan Hospital ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 69189-7772_6be071af-81ec-45b5-908a-16924d540e3f 69189-7772 HUMAN PRESCRIPTION DRUG Clozapine Clozapine TABLET ORAL 20150812 ANDA ANDA074949 Avera McKennan Hospital CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 69189-7915_c2d241cb-7b05-4394-bc90-ce1b29942cdb 69189-7915 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20161019 OTC MONOGRAPH NOT FINAL part343 Avera McKennan Hospital IBUPROFEN 200 mg/1 N 20181231 69189-8040_5b3e9a6a-0a10-41f4-a809-406f2c866f24 69189-8040 HUMAN PRESCRIPTION DRUG Morphine Sulfate Extended Release Morphine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150427 ANDA ANDA074769 Avera McKennan Hospital MORPHINE SULFATE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 69189-8088_f070f4c6-6ab9-4162-bf8b-3a085ccd4422 69189-8088 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen tramadol hydrochloride and acetaminophen TABLET, FILM COATED ORAL 20160210 ANDA ANDA077858 Avera McKennan Hospital TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 69189-8740_0b7e2436-fb70-451c-828d-1b485d0ac928 69189-8740 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20151026 ANDA ANDA074377 Avera McKennan Hospital MEXILETINE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC] N 20181231 69189-8940_c7f2579c-cc46-42a3-b494-773b50a88e60 69189-8940 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20150520 ANDA ANDA074578 Avera McKennan Hospital ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 69189-8943_d5e3256c-6542-4200-b0ec-4c85537c5eb0 69189-8943 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20150317 ANDA ANDA074556 Avera McKennan Hospital ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 69189-9030_1f7a0f81-db9b-46ef-a6a4-6e7ee040d7e3 69189-9030 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20150301 ANDA ANDA201190 Avera McKennan Hospital QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] E 20171231 69189-9296_54d82414-8ca3-4fdb-a271-87d42302c999 69189-9296 HUMAN PRESCRIPTION DRUG Synthroid Levothyroxine Sodium TABLET ORAL 20150309 NDA NDA021402 Avera McKennan Hospital LEVOTHYROXINE SODIUM 112 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] E 20171231 69189-9364_b89f09e5-5a7e-48e3-97dd-9f4b36fca565 69189-9364 HUMAN PRESCRIPTION DRUG Glyburide glyburide TABLET ORAL 20150301 NDA AUTHORIZED GENERIC NDA017532 Avera McKennan Hospital GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 69189-9652_6deb938c-97e7-46b3-9060-b947dffebc56 69189-9652 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate Prochlorperazine Maleate TABLET, FILM COATED ORAL 20150520 ANDA ANDA040120 Avera McKennan Hospital PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 69190-326_980b1be0-4ef2-4f6e-919d-7586ffaf154a 69190-326 HUMAN OTC DRUG FungiClear Natural EUCALYPTUS GLOBULUS LEAF, MELALEUCA ALTERNIFOLIA LEAF OIL TOPICAL 20140802 UNAPPROVED HOMEOPATHIC R AND S RESEARCH EUCALYPTUS GLOBULUS LEAF; MELALEUCA ALTERNIFOLIA LEAF 5; 5 g/100g; g/100g E 20171231 69190-336_37429304-6ae3-45b1-b8e5-729ec0c99fa4 69190-336 HUMAN OTC DRUG Fungal Free Nails Natural EUCALYPTUS GLOBULUS LEAF, MELALEUCA ALTERNIFOLIA LEAF OIL TOPICAL 20140802 UNAPPROVED HOMEOPATHIC R AND S RESEARCH EUCALYPTUS GLOBULUS LEAF; MELALEUCA ALTERNIFOLIA LEAF 5; 5 g/100g; g/100g E 20171231 69191-500_47f504d5-3ea9-5227-e054-00144ff88e88 69191-500 HUMAN OTC DRUG Dr. Richs Numbing LIDOCAINE GEL TOPICAL 20140827 OTC MONOGRAPH NOT FINAL part348 GenZ Online LLC LIDOCAINE 4 g/100g N 20181231 69192-0001_4db07c64-e385-444f-8d07-02d76010afab 69192-0001 HUMAN OTC DRUG Nexgen Restore Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Brain (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), Aacg-A, Aacg-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto Dhea (Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum, Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20140818 UNAPPROVED HOMEOPATHIC Next Generation Health CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 69195-1001_02505212-2247-4de8-866d-fe5ac88ee6b2 69195-1001 HUMAN OTC DRUG Haben Herb CHLORPHENIRAMINE MALEATE CAPSULE ORAL 20140827 OTC MONOGRAPH FINAL part341 Beverly Hills Holdings Co,. Ltd. CHLORPHENIRAMINE MALEATE 1.25 mg/1 E 20171231 69196-1001_6f8b613c-adf7-4ffa-ae9c-cfbd9d9fce62 69196-1001 HUMAN OTC DRUG Niagara S GLYCERIN SOAP TOPICAL 20140911 OTC MONOGRAPH FINAL part347 Sungwon Cosmetics GLYCERIN 1 g/100g N 20181231 69196-2001_0f4bd539-f8dc-29f6-e054-00144ff8d46c 69196-2001 HUMAN OTC DRUG Miracle of the Mose Hair Bar GLYCERIN SOAP TOPICAL 20140911 OTC MONOGRAPH FINAL part347 Sungwon Cosmetics GLYCERIN 1 g/100g N 20181231 69196-2002_06b8da74-900a-4d4f-a130-fa42a8ac0a66 69196-2002 HUMAN OTC DRUG Monagra GLYCERIN SOAP TOPICAL 20140911 OTC MONOGRAPH FINAL part347 Sungwon Cosmetics GLYCERIN 1 g/100g N 20181231 69197-001_48705e29-859b-4061-aa84-5fd0d8cf3736 69197-001 HUMAN OTC DRUG MAX LAX CHERRY Magnesium citrate LIQUID ORAL 20140901 OTC MONOGRAPH NOT FINAL part334 Command Brands LLC. MAGNESIUM CITRATE 2.65 mg/100mL N 20181231 69197-002_1e1251a8-f9dc-4cf1-8ab4-b75ec4518957 69197-002 HUMAN OTC DRUG MAX LAX LEMON Magnesium citrate LIQUID ORAL 20140901 OTC MONOGRAPH NOT FINAL part334 Command Brands LLC. MAGNESIUM CITRATE 2.65 mg/100mL N 20181231 69197-029_1ee20db9-f07e-4533-ae14-a5bdc88a5f45 69197-029 HUMAN OTC DRUG SED-MAX Acetaminophen 500 mg with Caffeine 65mg TABLET, COATED ORAL 20141126 OTC MONOGRAPH NOT FINAL part343 Command Brands, LLC ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 69198-700_47f5441d-e725-0485-e054-00144ff8d46c 69198-700 HUMAN OTC DRUG MANCORE MUSCLE MEND ROLL-ON PAIN RELIEVER HISTAMINE DIHYDROCHLORIDE LOTION TOPICAL 20140827 OTC MONOGRAPH NOT FINAL part348 R2 Distribution, LLC HISTAMINE DIHYDROCHLORIDE .6 mg/mL N 20181231 69199-010_5d8624e1-eec9-494e-8370-49ea8b8a1bdd 69199-010 HUMAN OTC DRUG Milky Dress The White Platinum Dimethicone CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part347 JR Cosmetic Co., Ltd DIMETHICONE 1.62 mg/65mL E 20171231 69201-241_2ba89060-37ae-4f6e-988b-86fa6e8b758d 69201-241 HUMAN OTC DRUG Vine Vera Resveratrol Zinfandel Radiance Octinoxate, Homosalate, Octisilate, Oxybenzone and Avobenzone CREAM TOPICAL 20141003 OTC MONOGRAPH NOT FINAL part352 Vivo Per-lei, Inc. OCTINOXATE; HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE 7.4; 6.2; 5; 3.1; 1.5 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 69201-852_c50f8b6d-6779-47bf-8c42-b53dcbee2931 69201-852 HUMAN OTC DRUG 24K Bio-Brightening Skin Tone Moisturizer SPF 30 Octinoxate, Homosalate, Octisilate, Oxybenzone and Avobenzone CREAM TOPICAL 20141003 OTC MONOGRAPH NOT FINAL part352 Vivo Per-lei, Inc. OCTINOXATE; HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE 7.4; 6.2; 5; 3.1; 1.5 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 69201-874_57c8ffbb-0def-43d7-bd3c-f51ea44d776e 69201-874 HUMAN OTC DRUG Venofye Orchard Bee Brilliance SPF 30 Octinoxate, Homosalate, Octisalate, Oxybenzone, Avobenzone CREAM TOPICAL 20150104 OTC MONOGRAPH NOT FINAL part352 Vivo Per-lei, Inc. OCTINOXATE; HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE 7.4; 6.2; 5; 3.1; 1.5 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 69201-966_8b932751-192a-4c9a-8d73-7851086a55b4 69201-966 HUMAN OTC DRUG 24K Bio-Brightening Dark Circle Eye SPF 30 Zinc Oxide and Titanium Oxide SOLUTION TOPICAL 20141003 OTC MONOGRAPH NOT FINAL part352 Vivo Per-lei, Inc. ZINC OXIDE; TITANIUM DIOXIDE 10; 5 g/100mL; g/100mL E 20171231 69202-780_b7161e6f-250f-4c46-af10-152ea96d4f9f 69202-780 HUMAN PRESCRIPTION DRUG Ulesfia benzyl alcohol LOTION TOPICAL 20150817 NDA NDA022129 Lachlan Pharmaceuticals BENZYL ALCOHOL 50 mg/g Pediculicide [EPC] N 20181231 69204-001_47448380-2c96-41b5-b691-86f8f4aa48cb 69204-001 HUMAN OTC DRUG Nasol Capsicum, Eucalyptus SPRAY NASAL 20140301 UNAPPROVED HOMEOPATHIC Natures Formulae Health Products Ltd. CAPSICUM; EUCALYPTUS GLOBULUS LEAF 4; 4 [hp_X]/30mL; [hp_X]/30mL E 20171231 69206-995_28e33f5c-a61c-4dfb-9438-97aa68a84870 69206-995 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20151014 OTC MONOGRAPH FINAL part341 Aventura Pharmaceuticals, LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 69207-0001_c3c54d7e-13b2-45cd-8eda-3b186e991efc 69207-0001 HUMAN OTC DRUG ESSENTIAL WEIGHT LOSS AMMONIUM BROMATUM, FUCUS VESICULOSUS, NATRUM SULPHURICUM, NICOTINAMIDUM, SPONGIA TOSTA, THIAMINUM HYDROCHLORICUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THYROIDINUM (BOVINE), CALCAREA CARBONICA, GRAPHITES LIQUID ORAL 20141203 UNAPPROVED HOMEOPATHIC Integrative Health Alliance AMMONIUM BROMIDE; FUCUS VESICULOSUS; SODIUM SULFATE; NIACINAMIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; THIAMINE HYDROCHLORIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THYROID, BOVINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE 3; 3; 3; 3; 3; 4; 6; 6; 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69208-005_4487c92a-513c-4cf1-8661-e54849bab85c 69208-005 HUMAN PRESCRIPTION DRUG Sodium Iodide I-131 Sodium Iodide I-131 SOLUTION, CONCENTRATE ORAL 20100901 UNAPPROVED DRUG OTHER International Isotopes Inc SODIUM IODIDE I-131 3500 mCi/mL Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 69216-001_e2363d79-3c6d-479d-9e3a-ff61b8bec029 69216-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140901 UNAPPROVED MEDICAL GAS Stateserv Medical of Arizona OXYGEN 99 L/100L E 20171231 69219-101_07d9fa3a-8e57-495c-91aa-6e029876d832 69219-101 HUMAN OTC DRUG PROTECTIVE MOISTURIZER SPF 15 ZINC OXIDE, OCTINOXATE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 SCIENCE OF SKINCARE LLC ZINC OXIDE; OCTINOXATE 4.2; 3.3 g/100g; g/100g N 20181231 69219-102_15fe749d-7629-4b94-8e73-e9e940a1e86a 69219-102 HUMAN OTC DRUG ECLIPSE SPF 50 ALL SHADES TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 SCIENCE OF SKINCARE LLC TITANIUM DIOXIDE; ZINC OXIDE 5.2; 1.1 g/100g; g/100g N 20181231 69219-103_696346bc-3a0e-4b5d-8c8b-96d7cf12668f 69219-103 HUMAN OTC DRUG EXTREME PROTECT SPF 30 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20141001 OTC MONOGRAPH FINAL part352 SCIENCE OF SKINCARE LLC OCTINOXATE; ZINC OXIDE 5.5; 4.12 g/100g; g/100g N 20191231 69221-203_4f1eb8ef-5209-74b5-e054-00144ff8d46c 69221-203 HUMAN OTC DRUG Zoono Hand Sanitizer benzalkonium chloride SOLUTION TOPICAL 20161109 OTC MONOGRAPH NOT FINAL part333E ZOONO USA, LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 69221-204_41fae81e-a2f6-1c07-e054-00144ff8d46c 69221-204 HUMAN OTC DRUG Zoono Wound Cleanser benzalkonium chloride SOLUTION TOPICAL 20161123 OTC MONOGRAPH NOT FINAL part333E ZOONO USA, LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 69221-301_5254eaa5-1f3b-0e93-e054-00144ff8d46c 69221-301 HUMAN OTC DRUG Zoono Skin Clear Acne Medication Acne Medication - Salicylic Acid LIQUID TOPICAL 20160916 OTC MONOGRAPH FINAL part333D Zoono USA, LLC SALICYLIC ACID 5 mg/mL N 20181231 69221-401_42ae8678-648a-6ce7-e054-00144ff88e88 69221-401 HUMAN OTC DRUG Zoono Foot Guard Benzalkonium Chloride LIQUID TOPICAL 20160930 OTC MONOGRAPH NOT FINAL part333E Zoono USA, LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 69221-410_4522a13f-9310-2ff4-e054-00144ff8d46c 69221-410 HUMAN OTC DRUG Zoono Odor Guard benzalkonium chloride SOLUTION TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part333E ZOONO USA, LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 69221-501_4147ff00-8e12-7335-e054-00144ff88e88 69221-501 HUMAN OTC DRUG Zoono Ultra Hand Sanitizer Alcohol LIQUID TOPICAL 20161114 OTC MONOGRAPH NOT FINAL part333E Zoono USA, LLC ALCOHOL 70 g/100mL N 20181231 69221-561_4340bd9a-446d-3aa6-e054-00144ff8d46c 69221-561 HUMAN OTC DRUG germfree 24 Hand Sanitizer benzalkonium chloride SOLUTION TOPICAL 20161017 OTC MONOGRAPH NOT FINAL part333E Zoono USA BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 69221-601_526cf041-4d6b-7438-e054-00144ff8d46c 69221-601 HUMAN OTC DRUG Zoono Alcohol Free Hand Sanitizer benzalkonium chloride SOLUTION TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part333E Zoono USA, LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 69222-000_26f5b55e-8a0b-4a6c-8dd0-f68a24f7b4a6 69222-000 HUMAN OTC DRUG whole health Hand Sanitizers 3-pack ETHYL ALCOHOL KIT 20140917 OTC MONOGRAPH NOT FINAL part333E Suzhou Jingying Daily Necessities Co., Ltd. E 20171231 69223-000_e9b2fd44-cb77-4f2c-98f7-25289dc97eb1 69223-000 HUMAN OTC DRUG Colgate Anticavity Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20140922 OTC MONOGRAPH FINAL part355 Zhuhai Jenny's Choice Manufacturing Limited SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g N 20181231 69224-1001_4b22d96e-ff3e-4621-a8d1-1568b90c5220 69224-1001 HUMAN OTC DRUG ATO ALL GLYCERIN LIQUID TOPICAL 20141017 OTC MONOGRAPH FINAL part347 GL BioTech GLYCERIN 2 g/100mL E 20171231 69224-2001_5bc6c8aa-7b68-4a1b-96ef-6b47c4978327 69224-2001 HUMAN OTC DRUG AC ALL GLYCERIN LIQUID TOPICAL 20141017 OTC MONOGRAPH FINAL part347 GL BioTech GLYCERIN 2 g/100mL E 20171231 69224-3001_7fa39a20-1da9-4810-a145-541095b074d1 69224-3001 HUMAN OTC DRUG Yeo Danbi GLYCERIN LIQUID TOPICAL 20141017 OTC MONOGRAPH FINAL part347 GL BioTech GLYCERIN 2 g/100mL E 20171231 69224-4001_7d033b70-acaa-4fcb-a803-f264a35d292b 69224-4001 HUMAN OTC DRUG MeWrinkle GLYCERIN LIQUID TOPICAL 20150903 OTC MONOGRAPH FINAL part347 GL BioTech GLYCERIN .5 g/100mL E 20171231 69224-5001_d37d2438-7133-4fdb-be8b-1d66612636e2 69224-5001 HUMAN OTC DRUG Antizom GLYCERIN LIQUID TOPICAL 20150910 OTC MONOGRAPH FINAL part347 GL BioTech GLYCERIN .5 g/100mL E 20171231 69225-1000_e50d75d0-b3e6-41d3-b335-969c9d0c7907 69225-1000 HUMAN OTC DRUG Antiseptic Bandages Benzalkonium chloride DRESSING TOPICAL 20140109 OTC MONOGRAPH NOT FINAL part333E Pharmaband BENZALKONIUM CHLORIDE .042 mg/1 E 20171231 69226-010_a02d6e27-8c77-4410-9777-1f6571a8a996 69226-010 HUMAN OTC DRUG REMAN HOMME SUN PROTECTION TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE STICK TOPICAL 20140930 OTC MONOGRAPH NOT FINAL part352 Pf Nature TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 2.13; 1.66; 1.54 g/22g; g/22g; g/22g E 20171231 69230-141_ccb769a8-32f5-4f0d-96af-2d04bf438d48 69230-141 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium Naproxen Sodium TABLET ORAL 20150526 ANDA ANDA090545 Camber Consumer Care NAPROXEN SODIUM 220 mg/1 N 20181231 69230-202_bddefe73-bfe2-4b72-b663-6a98790b8ded 69230-202 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET, FILM COATED ORAL 20150916 ANDA ANDA204507 Camber Consumer Care FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 69231-004_1fb16bc8-f9b0-4673-9422-c2ec322da8f8 69231-004 HUMAN OTC DRUG CCC Cream Light OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part352 KW ABSC, INC. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 2.25; 2.65; .9 mg/30mL; mg/30mL; mg/30mL E 20171231 69231-005_12264d7c-40e5-4800-8328-6316e84fb224 69231-005 HUMAN OTC DRUG CCC Cream Medium Light OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part352 KW ABSC, INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2.25; .9; 2.68 mg/30mL; mg/30mL; mg/30mL E 20171231 69231-006_06935c4d-273d-45aa-842b-56c841a47451 69231-006 HUMAN OTC DRUG CCC Cream Medium OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part352 KW ABSC, INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2.25; .9; 2.7 mg/30mL; mg/30mL; mg/30mL E 20171231 69231-007_711b264a-439a-4815-8024-50ea2b0d3804 69231-007 HUMAN OTC DRUG CCC Cream Medium Deep OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part352 KW ABSC, INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2.25; .3; 2.52 mg/30mL; mg/30mL; mg/30mL E 20171231 69231-008_f6894245-d6a3-4ff1-aa5a-8ebd08f0bcb9 69231-008 HUMAN OTC DRUG CCC Cream Deep OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part352 KW ABSC, INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2.25; .9; 2.52 mg/30mL; mg/30mL; mg/30mL E 20171231 69231-009_d007abec-05db-4f98-872f-1a9bb74bc17f 69231-009 HUMAN OTC DRUG Essence Air Cushion Light OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 KW ABSC, INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 1.13; .45; 1.4 mg/15g; mg/15g; mg/15g E 20171231 69231-010_a6ab2339-113e-4e73-b4dc-bb3adc5156ec 69231-010 HUMAN OTC DRUG Essence Air Cushion Medium Light OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 KW ABSC, INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 1.05; .45; 1.25 mg/15g; mg/15g; mg/15g E 20171231 69231-011_f6f8de6e-ae10-4ee5-82f6-81ff038c5d68 69231-011 HUMAN OTC DRUG Essence Air Cushion Medium OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part352 KW ABSC, INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 1.13; .45; 1.28 mg/15g; mg/15g; mg/15g E 20171231 69231-012_46652c11-ab2a-4236-9f79-0e2f7b4c5bf2 69231-012 HUMAN OTC DRUG Essence Air Cushion Medium Deep OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20151228 OTC MONOGRAPH NOT FINAL part352 KW ABSC, INC. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 1.13; .45; 1.28 mg/15g; mg/15g; mg/15g E 20171231 69232-001_e4f02d2c-ebef-491d-82ad-3d9513889483 69232-001 HUMAN OTC DRUG Natural Epsom Salt magnesium sulfate POWDER TOPICAL 20141009 OTC MONOGRAPH NOT FINAL part334 Anhui Twowin Machinery Imp. & Exp. Co., Ltd. MAGNESIUM SULFATE 10 g/10g E 20171231 69232-002_2b70e780-5b7e-2d97-e054-00144ff8d46c 69232-002 HUMAN OTC DRUG Natural Epsom Salt Lavender magnesium sulfate POWDER TOPICAL 20160126 OTC MONOGRAPH NOT FINAL part334 Anhui Twowin Machinery Imp. & Exp. Co., Ltd. MAGNESIUM SULFATE 10 g/10g E 20171231 69232-003_2b70a83f-e4e0-4828-e054-00144ff88e88 69232-003 HUMAN OTC DRUG Eucalyptus Scented Natural Epsom Salt magnesium sulfate POWDER TOPICAL 20160126 OTC MONOGRAPH NOT FINAL part334 Anhui Twowin Machinery Imp. & Exp. Co., Ltd. MAGNESIUM SULFATE 10 g/10g E 20171231 69232-004_2b70a83f-e4e1-4828-e054-00144ff88e88 69232-004 HUMAN OTC DRUG Green Tea Chamomile Natural Epsom Salt magnesium sulfate POWDER TOPICAL 20160126 OTC MONOGRAPH NOT FINAL part334 Anhui Twowin Machinery Imp. & Exp. Co., Ltd. MAGNESIUM SULFATE 10 g/10g E 20171231 69232-005_2b70a83f-e4e2-4828-e054-00144ff88e88 69232-005 HUMAN OTC DRUG Spearmint and Menthol scented Natural Epsom Salt magnesium sulfate POWDER TOPICAL 20160127 OTC MONOGRAPH NOT FINAL part334 Anhui Twowin Machinery Imp. & Exp. Co., Ltd. MAGNESIUM SULFATE 10 g/10g E 20171231 69233-644_48a82be6-a24e-1f78-e054-00144ff8d46c 69233-644 HUMAN OTC DRUG Reliaderm METHYL SALICYLATE, MENTHOL, CAPSAICIN CREAM TOPICAL 20140625 OTC MONOGRAPH NOT FINAL part348 Icon Health Services, Llc METHYL SALICYLATE; MENTHOL; CAPSAICIN 25; 10; .035 g/100g; g/100g; g/100g N 20181231 69233-666_54c06435-c908-612c-e054-00144ff8d46c 69233-666 HUMAN OTC DRUG Reliaderm METHYL SALICYLATE, MENTHOL, CAPSAICIN CREAM TOPICAL 20140625 OTC MONOGRAPH NOT FINAL part348 Icon Health Services, Llc METHYL SALICYLATE; MENTHOL; CAPSAICIN 250; 100; .35 mg/mL; mg/mL; mg/mL N 20181231 69233-843_57d5a080-3584-4510-e053-2a91aa0ad589 69233-843 HUMAN OTC DRUG SYREN Intimate Relief Topical Pain Relief LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part348 Icon Health Science LIDOCAINE HYDROCHLORIDE 40 mg/mL N 20181231 69235-310_629858bd-c07c-4ce6-8725-43b598bc36da 69235-310 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840911 ANDA ANDA062500 MHC Pharma, LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 69235-320_a233a01d-6859-4d95-b27e-589a614ae8b5 69235-320 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 MHC Pharma, LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 69235-350_629858bd-c07c-4ce6-8725-43b598bc36da 69235-350 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 19840911 ANDA ANDA062500 MHC Pharma, LLC DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 69238-1017_52b7944c-36d1-4943-8921-4724c207647a 69238-1017 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE, LIQUID FILLED ORAL 20171002 ANDA ANDA207792 Amneal Pharmaceuticals LLC ISOTRETINOIN 30 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 69238-1031_4d9decf8-4653-4217-993e-eae81ca461ce 69238-1031 HUMAN PRESCRIPTION DRUG Melodetta 24 Fe Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate KIT 20170921 ANDA ANDA207514 Amneal Pharmaceuticals LLC N 20181231 69238-1053_fec481a5-67d1-494f-84c5-16542d8a2114 69238-1053 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine TABLET, FILM COATED ORAL 20160321 ANDA ANDA208105 Amneal Pharmaceuticals LLC DESIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69238-1055_fec481a5-67d1-494f-84c5-16542d8a2114 69238-1055 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine TABLET, FILM COATED ORAL 20160321 ANDA ANDA208105 Amneal Pharmaceuticals LLC DESIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69238-1057_fec481a5-67d1-494f-84c5-16542d8a2114 69238-1057 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine TABLET, FILM COATED ORAL 20160321 ANDA ANDA208105 Amneal Pharmaceuticals LLC DESIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69238-1059_fec481a5-67d1-494f-84c5-16542d8a2114 69238-1059 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine TABLET, FILM COATED ORAL 20160321 ANDA ANDA208105 Amneal Pharmaceuticals LLC DESIPRAMINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69238-1061_fec481a5-67d1-494f-84c5-16542d8a2114 69238-1061 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine TABLET, FILM COATED ORAL 20160321 ANDA ANDA208105 Amneal Pharmaceuticals LLC DESIPRAMINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69238-1063_fec481a5-67d1-494f-84c5-16542d8a2114 69238-1063 HUMAN PRESCRIPTION DRUG Desipramine Hydrochloride Desipramine TABLET, FILM COATED ORAL 20160321 ANDA ANDA208105 Amneal Pharmaceuticals LLC DESIPRAMINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69238-1076_4dae7e24-f91e-4eed-9874-2d3c79406cb1 69238-1076 HUMAN PRESCRIPTION DRUG AZATHIOPRINE Azathioprine TABLET ORAL 20150202 ANDA ANDA074069 Amneal Pharmaceuticals of New York, LLC AZATHIOPRINE 50 mg/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 69238-1100_9c37f46c-f7a5-483f-a493-3b81e29c8773 69238-1100 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline CAPSULE ORAL 20160628 ANDA ANDA207289 Amneal Pharmaceuticals LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 69238-1101_db2c439a-2749-4d05-b7aa-cf653c499785 69238-1101 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20140401 ANDA ANDA078329 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69238-1102_db2c439a-2749-4d05-b7aa-cf653c499785 69238-1102 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20140401 ANDA ANDA078329 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69238-1103_db2c439a-2749-4d05-b7aa-cf653c499785 69238-1103 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20140401 ANDA ANDA078329 Amneal Pharmaceuticals of New York, LLC IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69238-1104_47e26b50-4129-4308-b693-226fa9f1c714 69238-1104 HUMAN PRESCRIPTION DRUG Tiagabine Hydrochloride Tiagabine TABLET ORAL 20171208 ANDA ANDA208181 Amneal Pharmaceuticals LLC TIAGABINE HYDROCHLORIDE 2 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69238-1105_47e26b50-4129-4308-b693-226fa9f1c714 69238-1105 HUMAN PRESCRIPTION DRUG Tiagabine Hydrochloride Tiagabine TABLET ORAL 20171208 ANDA ANDA208181 Amneal Pharmaceuticals LLC TIAGABINE HYDROCHLORIDE 4 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69238-1106_47e26b50-4129-4308-b693-226fa9f1c714 69238-1106 HUMAN PRESCRIPTION DRUG Tiagabine Hydrochloride Tiagabine TABLET ORAL 20171208 ANDA ANDA208181 Amneal Pharmaceuticals LLC TIAGABINE HYDROCHLORIDE 12 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69238-1107_47e26b50-4129-4308-b693-226fa9f1c714 69238-1107 HUMAN PRESCRIPTION DRUG Tiagabine Hydrochloride Tiagabine TABLET ORAL 20171208 ANDA ANDA208181 Amneal Pharmaceuticals LLC TIAGABINE HYDROCHLORIDE 16 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69238-1115_6872bd86-9f79-4b18-b40e-c3e1f401c020 69238-1115 HUMAN PRESCRIPTION DRUG busPIRone HCl buspirone hydrochloride TABLET ORAL 20170524 ANDA ANDA208829 Amneal Pharmaceuticals LLC BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 69238-1116_6872bd86-9f79-4b18-b40e-c3e1f401c020 69238-1116 HUMAN PRESCRIPTION DRUG busPIRone HCl buspirone hydrochloride TABLET ORAL 20170524 ANDA ANDA208829 Amneal Pharmaceuticals LLC BUSPIRONE HYDROCHLORIDE 7.5 mg/1 N 20181231 69238-1117_6872bd86-9f79-4b18-b40e-c3e1f401c020 69238-1117 HUMAN PRESCRIPTION DRUG busPIRone HCl buspirone hydrochloride TABLET ORAL 20170524 ANDA ANDA208829 Amneal Pharmaceuticals LLC BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 69238-1118_6872bd86-9f79-4b18-b40e-c3e1f401c020 69238-1118 HUMAN PRESCRIPTION DRUG busPIRone HCl buspirone hydrochloride TABLET ORAL 20170524 ANDA ANDA208829 Amneal Pharmaceuticals LLC BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 69238-1119_6872bd86-9f79-4b18-b40e-c3e1f401c020 69238-1119 HUMAN PRESCRIPTION DRUG busPIRone HCl buspirone hydrochloride TABLET ORAL 20170524 ANDA ANDA208829 Amneal Pharmaceuticals LLC BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 69238-1120_5a515d03-b3d0-4220-8783-5612414f3625 69238-1120 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20170504 ANDA ANDA208633 Amneal Pharmaceuticals LLC OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69238-1123_483cee6a-6f6c-4616-8eb7-a2f095460f3d 69238-1123 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20170602 ANDA ANDA208832 Amneal Pharmaceuticals LLC NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 69238-1124_483cee6a-6f6c-4616-8eb7-a2f095460f3d 69238-1124 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20170602 ANDA ANDA208832 Amneal Pharmaceuticals LLC NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 69238-1125_483cee6a-6f6c-4616-8eb7-a2f095460f3d 69238-1125 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20170602 ANDA ANDA208832 Amneal Pharmaceuticals LLC NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 69238-1154_ea087aa0-874f-4c4a-99c6-a9bec75e08d6 69238-1154 HUMAN PRESCRIPTION DRUG Ezetimibe Ezetimibe TABLET ORAL 20170612 ANDA ANDA208803 Amneal Pharmaceuticals LLC EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 69238-1155_4c851bff-43e3-4c84-9430-23cce69e9c1f 69238-1155 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20171121 ANDA ANDA208831 Amneal Pharmaceuticals LLC EZETIMIBE; SIMVASTATIN 10; 10 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69238-1156_4c851bff-43e3-4c84-9430-23cce69e9c1f 69238-1156 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20171121 ANDA ANDA208831 Amneal Pharmaceuticals LLC EZETIMIBE; SIMVASTATIN 10; 20 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69238-1157_4c851bff-43e3-4c84-9430-23cce69e9c1f 69238-1157 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20171121 ANDA ANDA208831 Amneal Pharmaceuticals LLC EZETIMIBE; SIMVASTATIN 10; 40 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69238-1158_4c851bff-43e3-4c84-9430-23cce69e9c1f 69238-1158 HUMAN PRESCRIPTION DRUG Ezetimibe and Simvastatin Ezetimibe and Simvastatin TABLET ORAL 20171121 ANDA ANDA208831 Amneal Pharmaceuticals LLC EZETIMIBE; SIMVASTATIN 10; 80 mg/1; mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69238-1166_645645e1-cc30-49e4-9579-fcd8c302c975 69238-1166 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20170628 ANDA ANDA207482 Amneal Pharmaceuticals LLC DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69238-1170_645645e1-cc30-49e4-9579-fcd8c302c975 69238-1170 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20170628 ANDA ANDA207482 Amneal Pharmaceuticals LLC DOXEPIN HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69238-1171_645645e1-cc30-49e4-9579-fcd8c302c975 69238-1171 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20160628 ANDA ANDA207482 Amneal Pharmaceuticals LLC DOXEPIN HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69238-1172_645645e1-cc30-49e4-9579-fcd8c302c975 69238-1172 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20170628 ANDA ANDA207482 Amneal Pharmaceuticals LLC DOXEPIN HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69238-1173_645645e1-cc30-49e4-9579-fcd8c302c975 69238-1173 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20170628 ANDA ANDA207482 Amneal Pharmaceuticals LLC DOXEPIN HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69238-1174_52b7944c-36d1-4943-8921-4724c207647a 69238-1174 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE, LIQUID FILLED ORAL 20171002 ANDA ANDA207792 Amneal Pharmaceuticals LLC ISOTRETINOIN 10 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 69238-1175_52b7944c-36d1-4943-8921-4724c207647a 69238-1175 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE, LIQUID FILLED ORAL 20171002 ANDA ANDA207792 Amneal Pharmaceuticals LLC ISOTRETINOIN 20 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 69238-1176_52b7944c-36d1-4943-8921-4724c207647a 69238-1176 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE, LIQUID FILLED ORAL 20171002 ANDA ANDA207792 Amneal Pharmaceuticals LLC ISOTRETINOIN 40 mg/1 Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 69238-1247_ad61d86b-04dc-4d86-9eee-ce1b453a22b8 69238-1247 HUMAN PRESCRIPTION DRUG Memantine and Donepezil Hydrochlorides Extended-release Memantine and Donepezil CAPSULE, EXTENDED RELEASE ORAL 20170201 ANDA ANDA208328 Amneal Pharmaceuticals LLC MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE 28; 10 mg/1; mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC],Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 69238-1248_ad61d86b-04dc-4d86-9eee-ce1b453a22b8 69238-1248 HUMAN PRESCRIPTION DRUG Memantine and Donepezil Hydrochlorides Extended-release Memantine and Donepezil CAPSULE, EXTENDED RELEASE ORAL 20170201 ANDA ANDA208328 Amneal Pharmaceuticals LLC MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE 14; 10 mg/1; mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC],Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 69238-1251_7adc7575-770b-43e0-849b-0956eb8bf591 69238-1251 HUMAN PRESCRIPTION DRUG Lopreeza estradiol/norethindrone acetate TABLET, FILM COATED ORAL 20141001 NDA AUTHORIZED GENERIC NDA020907 Amneal Pharmaceuticals LLC ESTRADIOL; NORETHINDRONE ACETATE 1; .5 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 69238-1252_7adc7575-770b-43e0-849b-0956eb8bf591 69238-1252 HUMAN PRESCRIPTION DRUG Lopreeza estradiol/norethindrone acetate TABLET, FILM COATED ORAL 20141001 NDA AUTHORIZED GENERIC NDA020907 Amneal Pharmaceuticals LLC ESTRADIOL; NORETHINDRONE ACETATE .5; .1 mg/1; mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 69238-1264_a4821a32-596e-4676-a69c-5eb399a76d34 69238-1264 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir CAPSULE ORAL 20170521 ANDA ANDA209093 Amneal Pharmaceuticals LLC OSELTAMIVIR PHOSPHATE 30 mg/1 N 20181231 69238-1265_a4821a32-596e-4676-a69c-5eb399a76d34 69238-1265 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir CAPSULE ORAL 20170521 ANDA ANDA209093 Amneal Pharmaceuticals LLC OSELTAMIVIR PHOSPHATE 45 mg/1 N 20181231 69238-1266_a4821a32-596e-4676-a69c-5eb399a76d34 69238-1266 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir CAPSULE ORAL 20170521 ANDA ANDA209093 Amneal Pharmaceuticals LLC OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 69238-1426_00511280-9d66-45d1-9381-fe1be8500b7c 69238-1426 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine TABLET, EXTENDED RELEASE ORAL 20171129 ANDA ANDA210052 Amneal Pharmaceuticals LLC CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 69238-1489_b9b9505d-e585-49d8-b6c1-1d44a5bf1600 69238-1489 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20171018 ANDA ANDA209724 Amneal Pharmaceuticals LLC BUMETANIDE .5 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 69238-1490_b9b9505d-e585-49d8-b6c1-1d44a5bf1600 69238-1490 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20171018 ANDA ANDA209724 Amneal Pharmaceuticals LLC BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 69238-1491_b9b9505d-e585-49d8-b6c1-1d44a5bf1600 69238-1491 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20171018 ANDA ANDA209724 Amneal Pharmaceuticals LLC BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 69238-1500_8bb5da97-150d-4488-abc7-68e5a2806f2d 69238-1500 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline TABLET ORAL 20171009 ANDA ANDA209372 Amneal Pharmaceuticals LLC DOXYCYCLINE 75 mg/1 N 20181231 69238-1501_8bb5da97-150d-4488-abc7-68e5a2806f2d 69238-1501 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline TABLET ORAL 20171009 ANDA ANDA209372 Amneal Pharmaceuticals LLC DOXYCYCLINE 150 mg/1 N 20181231 69238-1524_6d7fd8c5-1d86-479f-8498-2ad09cfe52f7 69238-1524 HUMAN PRESCRIPTION DRUG Yuvafem Estradiol TABLET VAGINAL 20160201 NDA AUTHORIZED GENERIC NDA020908 Amneal Pharmaceuticals LLC ESTRADIOL HEMIHYDRATE 10 ug/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] E 20171231 69238-1531_6585285b-975d-4f74-b9b6-d29685406ba8 69238-1531 HUMAN PRESCRIPTION DRUG Larissia levonorgestrel and ethinyl estradiol KIT 20160229 ANDA ANDA201108 Amneal Pharmaceuticals LLC N 20181231 69238-1551_f57665dc-2520-4db6-a553-f0540f36d63f 69238-1551 HUMAN PRESCRIPTION DRUG Femynor norgestimate and ethinyl estradiol KIT 20160615 ANDA ANDA203865 Amneal Pharmaceuticals LLC N 20181231 69238-1554_4e017dd1-d6f3-4643-ac7f-8598d226fde0 69238-1554 HUMAN PRESCRIPTION DRUG Lillow levonorgestrel and ethinyl estradiol KIT 20160703 ANDA ANDA201095 Amneal Pharmaceuticals LLC N 20181231 69238-1583_7d50964b-2334-4ad7-a5cc-36f4fcbfa86c 69238-1583 HUMAN PRESCRIPTION DRUG Norlyda norethindrone KIT 20160916 ANDA ANDA202260 Amneal Pharmaceuticals LLC N 20181231 69238-1607_9193e79a-0ce4-471c-82b7-6a3d4e84c59b 69238-1607 HUMAN PRESCRIPTION DRUG Tri Femynor norgestimate and ethinyl estradiol KIT 20161028 ANDA ANDA203870 Amneal Pharmaceuticals LLC N 20181231 69240-001_bd792c16-52cf-424f-901e-518516989190 69240-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140901 NDA NDA205767 Acute Care Gases II, LLC OXYGEN 99 L/100L N 20191231 69241-001_2a0ccc19-1f2f-47de-bebd-40ed92eb6fd8 69241-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20140901 NDA NDA205849 RTA Pediatric Care Inc. OXYGEN 99 L/100L N 20181231 69242-010_8c8cdf25-6630-47cf-a266-1dae9cff985b 69242-010 HUMAN OTC DRUG Smart Sunblock Puff ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20160615 OTC MONOGRAPH NOT FINAL part352 EASY POWDER CO., LTD. ZINC OXIDE; TITANIUM DIOXIDE 1.05; .71 g/7g; g/7g N 20181231 69243-0610_abe6cc43-de0c-4dfb-9eea-98b717ec243b 69243-0610 HUMAN OTC DRUG Germ Bloc Hand Sanitizer Benzalkonium Chloride LOTION TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A Willspeed Technologies LLC BENZALKONIUM CHLORIDE .0013 g/mL N 20181231 69243-0710_3e8b9567-acad-4d91-9997-5dc8bbebf2f5 69243-0710 HUMAN OTC DRUG Germ Bloc Hand Sanitizer Foam Peppermint Benzalkonium Chloride LIQUID TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A Willspeed Technologies LLC BENZALKONIUM CHLORIDE .001 g/mL N 20181231 69243-0810_9fdb21b9-7a73-40af-a1ef-2716f5fb7506 69243-0810 HUMAN OTC DRUG Germ Bloc Hand Sanitizer Benzalkonium Chloride SPRAY TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A Willspeed Technologies LLC BENZALKONIUM CHLORIDE .0013 g/mL N 20181231 69244-0001_3986a17f-b422-0bfc-e054-00144ff88e88 69244-0001 HUMAN OTC DRUG FOLLIGEN PYRITHIONE ZINC SHAMPOO TOPICAL 20160627 OTC MONOGRAPH FINAL part358H Humajor Co., Ltd. PYRITHIONE ZINC 1.008 g/100mL E 20171231 69244-0002_3986a17f-b42c-0bfc-e054-00144ff88e88 69244-0002 HUMAN OTC DRUG FOLLIGEN PLUS PYRITHIONE ZINC SHAMPOO TOPICAL 20160627 OTC MONOGRAPH FINAL part358H Humajor Co., Ltd. PYRITHIONE ZINC 1.008 g/100mL E 20171231 69244-0003_3986b2f4-f1ef-0233-e054-00144ff88e88 69244-0003 HUMAN OTC DRUG FOLLIGEN hgH RENOVATING PYRITHIONE ZINC SHAMPOO TOPICAL 20160627 OTC MONOGRAPH FINAL part358H Humajor Co., Ltd. PYRITHIONE ZINC .000048 g/100mL E 20171231 69244-0004_3986a17f-b436-0bfc-e054-00144ff88e88 69244-0004 HUMAN OTC DRUG PHYTO THERAPY MENTHOL SHAMPOO TOPICAL 20160627 UNAPPROVED DRUG OTHER Humajor Co., Ltd. MENTHOL .1 g/100mL E 20171231 69244-0005_3986a17f-b440-0bfc-e054-00144ff88e88 69244-0005 HUMAN OTC DRUG PHYTO THERAPY TREATMENT GLYCERIN SHAMPOO TOPICAL 20160627 UNAPPROVED DRUG OTHER Humajor Co., Ltd. GLYCERIN 2 g/100mL E 20171231 69244-0006_3986b2f4-f1f9-0233-e054-00144ff88e88 69244-0006 HUMAN OTC DRUG PHYTO THERAPY TREATMENT GLYCERIN LIQUID TOPICAL 20160627 UNAPPROVED DRUG OTHER Humajor Co., Ltd. GLYCERIN 2 g/100mL E 20171231 69244-1001_3986a17f-b44a-0bfc-e054-00144ff88e88 69244-1001 HUMAN OTC DRUG Medicell Scalp GLYCERIN SHAMPOO TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Humajor Co., Ltd. GLYCERIN 2 g/100mL E 20171231 69244-2001_3986a17f-b454-0bfc-e054-00144ff88e88 69244-2001 HUMAN OTC DRUG Plant Stemcell VEGF bFGF Tonic ALLANTOIN LIQUID TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Humajor Co., Ltd. ALLANTOIN .1 g/100mL E 20171231 69244-3001_3986a17f-b45e-0bfc-e054-00144ff88e88 69244-3001 HUMAN OTC DRUG Plant Stemcell VEGF bFGF Ample GLYCERIN LIQUID TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Humajor Co., Ltd. GLYCERIN 3 g/100mL E 20171231 69244-4001_3986a17f-b468-0bfc-e054-00144ff88e88 69244-4001 HUMAN OTC DRUG FOLLIGEN PYRITHIONE ZINC SHAMPOO TOPICAL 20141001 OTC MONOGRAPH FINAL part358H Humajor Co., Ltd. PYRITHIONE ZINC 2.1 g/100mL E 20171231 69244-5001_3986a17f-b472-0bfc-e054-00144ff88e88 69244-5001 HUMAN OTC DRUG Dr.ZUMI SCALP PYRITHIONE ZINC SHAMPOO TOPICAL 20150423 OTC MONOGRAPH FINAL part358H Humajor Co., Ltd. PYRITHIONE ZINC 2.1 g/100mL E 20171231 69244-6001_3986a17f-b47c-0bfc-e054-00144ff88e88 69244-6001 HUMAN OTC DRUG Honey Bomb Beauty GLYCERIN SOAP TOPICAL 20150624 OTC MONOGRAPH FINAL part346 Humajor Co., Ltd. GLYCERIN 1 g/100g E 20171231 69244-7001_3986a17f-b486-0bfc-e054-00144ff88e88 69244-7001 HUMAN OTC DRUG ZUMISKIN Honey Boom GLYCERIN SOAP TOPICAL 20150624 OTC MONOGRAPH FINAL part346 Humajor Co., Ltd. GLYCERIN 1 g/100g E 20171231 69245-1001_ef10ac61-6ffa-40d8-9124-ece4507438f0 69245-1001 HUMAN OTC DRUG Chun-Shim Haedoksan REHMANNIA GLUTINOSA ROOT POWDER ORAL 20130708 UNAPPROVED DRUG OTHER HAMABIO Co., Ltd. REHMANNIA GLUTINOSA ROOT 5 g/100g E 20171231 69246-001_094b3b08-a438-49db-93dd-e09fc24b7039 69246-001 HUMAN OTC DRUG Antiseptic Hand Cleansing Gel ETHYL ALCOHOL GEL TOPICAL 20140924 OTC MONOGRAPH NOT FINAL part333E Playaction LLC ALCOHOL 62 mL/100mL N 20181231 69249-000_4b7ec52d-6c36-639f-e054-00144ff8d46c 69249-000 HUMAN OTC DRUG POVIOFIX Antiseptic POVIDONE-IODINE SOLUTION TOPICAL 20140925 OTC MONOGRAPH NOT FINAL part333E NATUREL MEDIKAL ILAC SANAYI VE TICARET LIMITED SIRKETI POVIDONE-IODINE 100 mg/mL N 20181231 69250-661_03be8a96-c164-0e22-e054-00144ff8d46c 69250-661 HUMAN OTC DRUG Alcohol Prep Pad Alcohol Prep Pad SPONGE TOPICAL 20141030 UNAPPROVED DRUG OTHER BioMed Resource Inc. ISOPROPYL ALCOHOL 7 mL/10mL N 20181231 69251-201_07aed8f3-a904-4a0e-a20d-b5d5e9e07d97 69251-201 HUMAN PRESCRIPTION DRUG Otiprio ciprofloxacin SUSPENSION INTRATYMPANIC 20160211 NDA NDA207986 Otonomy, Inc. CIPROFLOXACIN 6 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 69255-010_1b7c5434-ae74-46e6-91a6-2b096acb414a 69255-010 HUMAN OTC DRUG DR DENTAL CARE 750ML SODIUM FLUORIDE LIQUID TOPICAL 20140801 OTC MONOGRAPH FINAL part355 Jangin Pharm Co., Ltd. SODIUM FLUORIDE .15 mg/750mL E 20171231 69255-020_7bfc899b-6f39-484b-8976-55b260f37744 69255-020 HUMAN OTC DRUG DR DENTAL CARE 250ML SODIUM FLUORIDE LIQUID TOPICAL 20140801 OTC MONOGRAPH FINAL part355 Jangin Pharm Co., Ltd. SODIUM FLUORIDE .05 mg/250mL E 20171231 69255-030_9103dfa2-8347-4dc7-861d-6b0bb249796f 69255-030 HUMAN OTC DRUG DR DENTAL CARE 80ML SODIUM FLUORIDE LIQUID TOPICAL 20140801 OTC MONOGRAPH FINAL part355 Jangin Pharm Co., Ltd. SODIUM FLUORIDE .016 mg/80mL E 20171231 69256-001_44de94ae-f1d1-4f0f-9725-55611fa2e528 69256-001 HUMAN OTC DRUG harris teeter hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20171012 OTC MONOGRAPH FINAL part346 Harris Teeter, LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 69256-004_3297fc6a-f440-4bbb-aae2-5d08e44d97ce 69256-004 HUMAN OTC DRUG HARRIS TEETER ACID REDUCER COMPLETE famotidine, calcium carbonate and magnesium hydroxide TABLET, CHEWABLE ORAL 20171012 ANDA ANDA077355 Harris Teeter, LLC FAMOTIDINE; MAGNESIUM HYDROXIDE; CALCIUM CARBONATE 10; 165; 800 mg/1; mg/1; mg/1 N 20181231 69256-013_6ac8fb3f-d83f-4157-847c-ed8d5e53ef21 69256-013 HUMAN OTC DRUG Harris Teeter Allergy and Congestion Relief Loratadine, Pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20160916 ANDA ANDA076050 Harris Teeter, LLC LORATADINE; PSEUDOEPHEDRINE SULFATE 5; 120 mg/1; mg/1 N 20181231 69256-022_53a724c2-b0da-4043-85a3-ec75966b4803 69256-022 HUMAN OTC DRUG harris teeter acid reducer Cimetidine TABLET ORAL 20150330 ANDA ANDA075285 Harris Teeter, LLC CIMETIDINE 200 mg/1 N 20181231 69256-030_0caf2a51-5bdd-476d-9b18-809a3e4be836 69256-030 HUMAN OTC DRUG Salicylic Acid Medicated Corn Removers PATCH TOPICAL 20171220 OTC MONOGRAPH FINAL part358F Harris Teeter, LLC SALICYLIC ACID 40 mg/91 N 20181231 69256-031_9e605910-3405-4d86-b445-78a7dd48a0a4 69256-031 HUMAN OTC DRUG Salicylic Acid Medicated Callus Removers PATCH TOPICAL 20120103 OTC MONOGRAPH FINAL part358F Harris Teeter, LLC SALICYLIC ACID 40 mg/41 N 20181231 69256-032_3f905f6e-b25b-4e7f-b848-b4779649b030 69256-032 HUMAN OTC DRUG Miconazole Nitrate Jock Itch Spray AEROSOL, SPRAY TOPICAL 20171220 OTC MONOGRAPH FINAL part333C Harris Teeter, LLC MICONAZOLE NITRATE 1.3 g/131g N 20181231 69256-033_ab9dd9e7-fec8-461a-b1c9-f94b990cbbdc 69256-033 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate Antifungal Powder Spray AEROSOL, SPRAY TOPICAL 20171220 OTC MONOGRAPH FINAL part333C Harris Teeter, LLC MICONAZOLE NITRATE 2.6 g/130g N 20181231 69256-034_61a6675b-ed92-41ec-982c-3028b45b68b6 69256-034 HUMAN OTC DRUG Tolnaftate Antifungal Liquid Spray AEROSOL, SPRAY TOPICAL 20171221 OTC MONOGRAPH FINAL part333C Harris Teeter, LLC TOLNAFTATE 1.5 g/150g N 20181231 69256-035_d3da2f3f-99e3-4ed1-961d-8b79b67103f7 69256-035 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid LIQUID TOPICAL 20171221 OTC MONOGRAPH FINAL part358B Harris Teeter, LLC SALICYLIC ACID .17 mg/9mL N 20181231 69256-036_a1ea0f42-10f2-4f9d-a3b1-08f1e4f92e07 69256-036 HUMAN OTC DRUG Salicylic Acid Liquid Corn and Callus Remover LIQUID TOPICAL 20171221 OTC MONOGRAPH FINAL part358B Harris Teeter, LLC SALICYLIC ACID .17 mg/9.8mL N 20181231 69256-037_fa58a544-ae0d-45e1-a861-c25a0fd2e5b3 69256-037 HUMAN OTC DRUG Benzethonium chloride Plus Dyclonine hydrochloride Liquid Bandage LIQUID TOPICAL 20140710 OTC MONOGRAPH NOT FINAL part333A Harris Teeter, LLC BENZETHONIUM CHLORIDE; 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200 mg/1; mg/1 N 20181231 69256-054_c97fe188-2584-4fa2-8158-5d304f579a31 69256-054 HUMAN OTC DRUG Harris Teeter Sinus 12 Hour Pseudoephedrine HCl TABLET, FILM COATED, EXTENDED RELEASE ORAL 20150623 ANDA ANDA075153 Harris Teeter, LLC PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 69256-056_73ddb245-32b5-41f0-b094-32bf7341fed0 69256-056 HUMAN OTC DRUG Harris Teeter NightTime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, GELATIN COATED ORAL 20151121 OTC MONOGRAPH FINAL part341 Harris Teeter, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 69256-057_6d3f2d87-4f22-4343-b8ee-c1a4b18362a0 69256-057 HUMAN OTC DRUG Harris Teeter Ibuprofen Infants ibuprofen SUSPENSION ORAL 20151121 ANDA ANDA075217 Harris Teeter, LLC IBUPROFEN 50 mg/1.25mL N 20181231 69256-061_f3ceeac0-5af3-4fdd-a650-5a244b74e989 69256-061 HUMAN OTC DRUG Harris Teeter Allergy Relief Nasal Fluticasone propionate SPRAY, METERED NASAL 20160731 ANDA ANDA207957 Harris Teeter, LLC FLUTICASONE PROPIONATE 50 ug/1 N 20191231 69256-081_b5133b7d-b42a-4c4f-a811-6e16ff174848 69256-081 HUMAN OTC DRUG Harris Teeter Miconazole 3 Miconazole nitrate KIT 20151121 ANDA ANDA075329 Harris Teeter, LLC N 20181231 69256-105_468d6691-93c1-480b-8f5a-ef2eda061932 69256-105 HUMAN OTC DRUG Harris Teeter Childrens Pain and Fever Acetaminophen SUSPENSION ORAL 20151121 OTC MONOGRAPH NOT FINAL part343 Harris Teeter, LLC ACETAMINOPHEN 160 mg/5mL N 20181231 69256-124_5317ba3a-0a7d-467c-a864-bc202a820ccc 69256-124 HUMAN OTC DRUG Harris Teeter Nicotine Nicotine Polacrilex LOZENGE ORAL 20150604 ANDA ANDA090711 Harris Teeter, LLC NICOTINE 2 mg/1 N 20181231 69256-141_af2c0c51-ac28-4bf4-8e60-ba6e12bfc302 69256-141 HUMAN OTC DRUG harris teeter acid reducer Famotidine TABLET ORAL 20171012 ANDA ANDA075400 Harris Teeter, LLC FAMOTIDINE 10 mg/1 N 20181231 69256-144_fd920c9b-3c47-4f31-b9bb-7baf79cc3205 69256-144 HUMAN OTC DRUG Harris Teeter Mucus Relief D Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20160916 ANDA ANDA091071 Harris Teeter, LLC GUAIFENESIN; 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ZINC OXIDE 160 mg/mL N 20181231 69256-432_83f74035-ce78-4650-a7f6-365e1e1af4a7 69256-432 HUMAN OTC DRUG Harris Teeter Sinus Pseudoephedrine HCl TABLET, FILM COATED ORAL 20150623 OTC MONOGRAPH FINAL part341 Harris Teeter, LLC PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 69256-441_9cfc23c1-0d63-4122-811f-806ebafedb10 69256-441 HUMAN OTC DRUG Harris Teeter Sleep Aid Doxylamine succinate TABLET ORAL 20151121 ANDA ANDA040167 Harris Teeter, LLC DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 69256-443_dfc9225b-c270-4231-9b4f-8f4cff905938 69256-443 HUMAN OTC DRUG Harris Teeter Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20170118 ANDA ANDA078104 Harris Teeter, LLC TRIAMCINOLONE ACETONIDE 55 ug/1 N 20191231 69256-458_b2ae3c86-fea8-41ba-bf22-4b12a5c876dc 69256-458 HUMAN OTC DRUG Harris Teeter All Day Allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20150624 ANDA ANDA078336 Harris Teeter, LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 69256-459_a4c3e2ad-efa8-4895-a5fe-3367ebe8d3de 69256-459 HUMAN OTC DRUG Harris Teeter NightTime Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20150924 OTC MONOGRAPH FINAL part341 Harris Teeter, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 69256-468_18d17cc4-22b0-4546-a81c-c4838794f29f 69256-468 HUMAN OTC DRUG DayTime Cold Flu Non Drowsy Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20160131 OTC MONOGRAPH FINAL part341 Harris Teeter, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 69256-470_758b4721-ade3-4956-a7ea-d5ba999afe4a 69256-470 HUMAN OTC DRUG Cold and Flu Relief Daytime Non Drowsy ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH FINAL part341 Harris Teeter, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 69256-475_7ebf2da3-eb3d-48d7-b16d-8e8cff9c9924 69256-475 HUMAN OTC DRUG Harris Teeter Childrens All Day Allergy Cetirizine HCl SOLUTION ORAL 20160108 ANDA ANDA204226 Harris Teeter, LLC CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 69256-486_60af6800-b73b-4e55-b893-dba0b7d8c4f9 69256-486 HUMAN OTC DRUG Harris Teeter Stool Softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20171024 OTC MONOGRAPH NOT FINAL part334 Harris Teeter, LLC DOCUSATE SODIUM 100 mg/1 N 20181231 69256-515_5cca6b4b-d890-1c7d-e053-2991aa0a051f 69256-515 HUMAN OTC DRUG Harris Teeter Castor Oil Castor Oil LIQUID ORAL 20080101 OTC MONOGRAPH NOT FINAL part334 Harris Teeter, LLC CASTOR OIL 1 mg/mL N 20181231 69256-516_54cb2f97-3138-43cc-864c-b44795ab4f6d 69256-516 HUMAN OTC DRUG Harris Teeter Tussin Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20151121 OTC MONOGRAPH FINAL part341 Harris Teeter, LLC DEXTROMETHORPHAN HYDROBROMIDE; 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GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 69256-825_63e06c0b-664a-40ea-87ba-4f19451d0820 69256-825 HUMAN OTC DRUG Harris Teeter Miconazole 7 Miconazole nitrate CREAM VAGINAL 20151121 ANDA ANDA074760 Harris Teeter, LLC MICONAZOLE NITRATE 2 g/100g N 20181231 69256-831_c62d3fae-f3ca-4d78-9827-477ebeb00d17 69256-831 HUMAN OTC DRUG Harris Teeter Mineral OIL ORAL 20170503 OTC MONOGRAPH NOT FINAL part334 Harris Teeter MINERAL OIL 999 mg/mL N 20181231 69256-837_9e9e6961-bb5c-446c-9e95-d203882bbb8b 69256-837 HUMAN OTC DRUG Harris Teeter Acetaminophen PM Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20160613 OTC MONOGRAPH NOT FINAL part343 Harris Teeter, LLC ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 69256-851_b5c55a2c-01c8-404c-b414-dc2ab74de5ae 69256-851 HUMAN OTC DRUG harris teeter antacid Aluminum hydroxide, Magnesium hydroxide, Simethicone SUSPENSION ORAL 20150321 OTC MONOGRAPH FINAL part332 Harris Teeter, LLC ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; 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ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-0405_d7b580d3-4334-419a-b067-f0f2ddc2760a 69259-0405 HUMAN OTC DRUG Bye Bye Foundation Full Coverage Moisturizer SPF 50 Light TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170912 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-0412_d7b580d3-4334-419a-b067-f0f2ddc2760a 69259-0412 HUMAN OTC DRUG Bye Bye Foundation Full Coverage Moisturizer SPF 50 Medium TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170912 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-0429_d7b580d3-4334-419a-b067-f0f2ddc2760a 69259-0429 HUMAN OTC DRUG Bye Bye Foundation Full Coverage Moisturizer SPF 50 Medium Tan TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170912 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-0436_d7b580d3-4334-419a-b067-f0f2ddc2760a 69259-0436 HUMAN OTC DRUG Bye Bye Foundation Full Coverage Moisturizer SPF 50 Neutral Tan TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170912 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; 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ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-0668_524bd8be-190e-4b15-922e-b1991389d191 69259-0668 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-0675_95de8925-9187-48f1-9475-bb76d4772b13 69259-0675 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 TAN TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-0682_de04ec5e-2e2c-4367-a50e-b1ad882b01a9 69259-0682 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 RICH TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20160809 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-0719_d7b580d3-4334-419a-b067-f0f2ddc2760a 69259-0719 HUMAN OTC DRUG Bye Bye Foundation Full Coverage Moisturizer SPF 50 Neutral Medium TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170912 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; 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ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-1566_76d3a6dc-193d-4fb1-ac71-2c19654aa951 69259-1566 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 LIGHT TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-1573_524bd8be-190e-4b15-922e-b1991389d191 69259-1573 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-1580_95de8925-9187-48f1-9475-bb76d4772b13 69259-1580 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 TAN TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-1597_de04ec5e-2e2c-4367-a50e-b1ad882b01a9 69259-1597 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 RICH TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20160809 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-1603_76d3a6dc-193d-4fb1-ac71-2c19654aa951 69259-1603 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 LIGHT TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-1610_524bd8be-190e-4b15-922e-b1991389d191 69259-1610 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-1627_95de8925-9187-48f1-9475-bb76d4772b13 69259-1627 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 TAN TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-1634_de04ec5e-2e2c-4367-a50e-b1ad882b01a9 69259-1634 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 RICH TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20160809 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-2101_7cbdf959-ef9b-40e8-a6fb-911aa73ca3a2 69259-2101 HUMAN OTC DRUG CC VEIL BEAUTY FLUID FOUNDATION FAIR Titanium dioxide and zinc oxide EMULSION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 12.1; 6.3 g/100mL; g/100mL E 20171231 69259-2102_7cbdf959-ef9b-40e8-a6fb-911aa73ca3a2 69259-2102 HUMAN OTC DRUG CC VEIL BEAUTY FLUID FOUNDATION LIGHT Titanium dioxide and zinc oxide EMULSION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 12.1; 6.3 g/100mL; g/100mL E 20171231 69259-2104_7cbdf959-ef9b-40e8-a6fb-911aa73ca3a2 69259-2104 HUMAN OTC DRUG CC VEIL BEAUTY FLUID FOUNDATION MEDIUM Titanium dioxide and zinc oxide EMULSION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 12.1; 6.3 g/100mL; g/100mL E 20171231 69259-2201_7cbdf959-ef9b-40e8-a6fb-911aa73ca3a2 69259-2201 HUMAN OTC DRUG CC VEIL BEAUTY FLUID FOUNDATION TAN Titanium dioxide and zinc oxide EMULSION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 12.1; 6.3 g/100mL; g/100mL E 20171231 69259-2202_7cbdf959-ef9b-40e8-a6fb-911aa73ca3a2 69259-2202 HUMAN OTC DRUG CC VEIL BEAUTY FLUID FOUNDATION RICH Titanium dioxide and zinc oxide EMULSION TOPICAL 20141015 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 12.1; 6.3 g/100mL; g/100mL E 20171231 69259-2372_31e38b52-d425-4bfa-925d-61d67a7e9936 69259-2372 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 FAIR TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-2389_76d3a6dc-193d-4fb1-ac71-2c19654aa951 69259-2389 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 LIGHT TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-2396_524bd8be-190e-4b15-922e-b1991389d191 69259-2396 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-2402_95de8925-9187-48f1-9475-bb76d4772b13 69259-2402 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 TAN TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-2419_de04ec5e-2e2c-4367-a50e-b1ad882b01a9 69259-2419 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 RICH TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20160809 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-3300_4b22849f-3bed-4640-a215-ff5a1b71b2fe 69259-3300 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC EYE FAIR TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-3317_4b22849f-3bed-4640-a215-ff5a1b71b2fe 69259-3317 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC EYE LIGHT TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-3324_4b22849f-3bed-4640-a215-ff5a1b71b2fe 69259-3324 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC EYE MEDIUM TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-3331_4b22849f-3bed-4640-a215-ff5a1b71b2fe 69259-3331 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC EYE TAN TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-3348_4b22849f-3bed-4640-a215-ff5a1b71b2fe 69259-3348 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC EYE RICH TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-3904_170fc6b8-7900-4394-948e-da09ce30dca1 69259-3904 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC ILLUMINATION FAIR TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-3911_170fc6b8-7900-4394-948e-da09ce30dca1 69259-3911 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC ILLUMINATION LIGHT TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-3928_170fc6b8-7900-4394-948e-da09ce30dca1 69259-3928 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-3935_170fc6b8-7900-4394-948e-da09ce30dca1 69259-3935 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC ILLUMINATION TAN TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-3942_170fc6b8-7900-4394-948e-da09ce30dca1 69259-3942 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC ILLUMINATION RICH TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20150220 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL E 20171231 69259-3959_e1b8158f-c739-440d-bbcc-551a2d8f6f74 69259-3959 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC BRONZER BRONZE GLOW TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-3980_c03c7dbf-ab00-485a-8230-94090a65303f 69259-3980 HUMAN OTC DRUG YOUR SKIN BUT BETTER AIRBRUSH PERFECTING FAIR TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-3997_c03c7dbf-ab00-485a-8230-94090a65303f 69259-3997 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING LIGHT TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-4000_c03c7dbf-ab00-485a-8230-94090a65303f 69259-4000 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING MEDIUM TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-4017_c03c7dbf-ab00-485a-8230-94090a65303f 69259-4017 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING TAN TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-4024_c03c7dbf-ab00-485a-8230-94090a65303f 69259-4024 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING RICH TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-4079_96e1ae9f-580f-4d26-b168-9edb39b30cba 69259-4079 HUMAN OTC DRUG CELEBRATION FOUNDATION FAIR TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-4086_96e1ae9f-580f-4d26-b168-9edb39b30cba 69259-4086 HUMAN OTC DRUG CELEBRATION FOUNDATION LIGHT TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-4093_96e1ae9f-580f-4d26-b168-9edb39b30cba 69259-4093 HUMAN OTC DRUG CELEBRATION FOUNDATION MEDIUM TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-4109_96e1ae9f-580f-4d26-b168-9edb39b30cba 69259-4109 HUMAN OTC DRUG CELEBRATION FOUNDATION TAN TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-4116_96e1ae9f-580f-4d26-b168-9edb39b30cba 69259-4116 HUMAN OTC DRUG CELEBRATION FOUNDATION RICH TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-5199_0fd6486e-3eec-4885-9347-b3e4373077f0 69259-5199 HUMAN OTC DRUG ANTI-AGING ARMOUR SUPER SMART SKIN-PERFECTING BEAUTY FLUID SPF 50 Titanium dioxide and zinc oxide LOTION TOPICAL 20160726 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 12.1; 6.3 g/100mL; g/100mL E 20171231 69259-8077_273c2f16-0e85-4a2d-8fb4-1dc7c6c6cf05 69259-8077 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM-TAN TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-8084_273c2f16-0e85-4a2d-8fb4-1dc7c6c6cf05 69259-8084 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 DEEP TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-8091_a30f2dc8-e630-4cbb-986d-cba7eb21455d 69259-8091 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM-TAN TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170120 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-8107_a30f2dc8-e630-4cbb-986d-cba7eb21455d 69259-8107 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC ILLUMINATION DEEP TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170120 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-8152_c03c7dbf-ab00-485a-8230-94090a65303f 69259-8152 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING MEDIUM TAN TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-8169_c03c7dbf-ab00-485a-8230-94090a65303f 69259-8169 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING DEEP TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-8176_96e1ae9f-580f-4d26-b168-9edb39b30cba 69259-8176 HUMAN OTC DRUG CELEBRATION FOUNDATION MEDIUM TAN TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-8183_96e1ae9f-580f-4d26-b168-9edb39b30cba 69259-8183 HUMAN OTC DRUG CELEBRATION FOUNDATION DEEP TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-9630_b963da90-1177-4b2d-bae9-704d351d4e45 69259-9630 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING ILLUMINATION FAIR TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-9647_b963da90-1177-4b2d-bae9-704d351d4e45 69259-9647 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING ILLUMINATION LIGHT TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-9654_b963da90-1177-4b2d-bae9-704d351d4e45 69259-9654 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING ILLUMINATION MEDIUM TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-9661_b963da90-1177-4b2d-bae9-704d351d4e45 69259-9661 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING ILLUMINATION MEDIUM TAN TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-9678_b963da90-1177-4b2d-bae9-704d351d4e45 69259-9678 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING ILLUMINATION TAN TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-9685_b963da90-1177-4b2d-bae9-704d351d4e45 69259-9685 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING ILLUMINATION RICH TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-9692_b963da90-1177-4b2d-bae9-704d351d4e45 69259-9692 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC AIRBRUSH PERFECTING ILLUMINATION DEEP TITANIUM DIOXIDE AND ZINC OXIDE POWDER TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 20; 16 g/100g; g/100g N 20181231 69259-9876_273c2f16-0e85-4a2d-8fb4-1dc7c6c6cf05 69259-9876 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM TAN TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-9883_273c2f16-0e85-4a2d-8fb4-1dc7c6c6cf05 69259-9883 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 RICH TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69259-9890_273c2f16-0e85-4a2d-8fb4-1dc7c6c6cf05 69259-9890 HUMAN OTC DRUG YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 DEEP TITANIUM DIOXIDE AND ZINC OXIDE CREAM TOPICAL 20170727 OTC MONOGRAPH NOT FINAL part352 IT COSMETICS, LLC TITANIUM DIOXIDE; ZINC OXIDE 9; 6.3 g/100mL; g/100mL N 20181231 69261-001_4d0ec8bc-36be-3347-e054-00144ff88e88 69261-001 HUMAN OTC DRUG Quip SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20141001 OTC MONOGRAPH FINAL part355 Quip NYC Inc. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 69263-816_18e323fb-e907-1d94-e054-00144ff88e88 69263-816 HUMAN PRESCRIPTION DRUG B12 Inject Kit Cyanocobalamin KIT INTRAMUSCULAR; SUBCUTANEOUS 20150619 ANDA ANDA080557 Oaklock, LLC E 20171231 69263-819_1a5e832b-5705-3cc6-e054-00144ff8d46c 69263-819 HUMAN PRESCRIPTION DRUG B12 Inject Kit Cyanocobalamin KIT INTRAMUSCULAR; SUBCUTANEOUS 20150708 ANDA ANDA080737 Oaklock, LLC E 20171231 69263-820_5df51313-ffe3-edd4-e053-2991aa0ab928 69263-820 HUMAN PRESCRIPTION DRUG Pro-C-Dure 5 Kit kenalog KIT INTRA-ARTICULAR; INTRAMUSCULAR 20150817 NDA NDA014901 Oaklock, LLC N 20181231 69263-821_5df51b6f-6dc2-00eb-e053-2991aa0a020c 69263-821 HUMAN PRESCRIPTION DRUG Pro-C-Dure 6 Kit kenalog KIT INTRA-ARTICULAR; INTRAMUSCULAR 20150817 NDA NDA014901 Oaklock, LLC N 20181231 69263-822_5df51313-ffa3-edd4-e053-2991aa0ab928 69263-822 HUMAN PRESCRIPTION DRUG Beta 1 Kit Betamethasone Sodium Phosphate, Betamethasone Acetate KIT INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR 20150825 ANDA ANDA090747 Oaklock, LLC N 20181231 69263-911_5df5fb5c-1a74-e6c0-e053-2991aa0a391e 69263-911 HUMAN PRESCRIPTION DRUG VacuStim Black Negative Pressure Wound Therapy Lidocaine Dressing Kit KIT TOPICAL 20151118 ANDA ANDA088803 Oaklock, LLC N 20181231 69263-912_3fa2163d-90e1-5a1f-e054-00144ff8d46c 69263-912 HUMAN PRESCRIPTION DRUG VacuStim Silver Negative Pressure Wound Therapy Lidocaine Dressing Kit KIT TOPICAL 20161013 ANDA ANDA088803 Oaklock, LLC N 20181231 69263-920_542a42c6-cc33-087c-e054-00144ff88e88 69263-920 HUMAN PRESCRIPTION DRUG Wound Debridement Kit wound debridement kit KIT TOPICAL 20151118 ANDA ANDA088803 Oaklock, LLC N 20181231 69264-014_4a8a9ec2-6fc1-4881-8a5b-a4f229933cfc 69264-014 HUMAN OTC DRUG Callus Removal Foot Pack Salicylic acid 0.19% PATCH TOPICAL 20141016 OTC MONOGRAPH FINAL part358B POLAROISIN INTERNATIONAL CO., LTD. SALICYLIC ACID .19 mg/1 E 20171231 69264-016_eee53321-ca57-416f-8c1e-36f205a387a7 69264-016 HUMAN OTC DRUG Callus Removal Foot Pack Salicylic acid PATCH TOPICAL 20151217 OTC MONOGRAPH FINAL part358F POLAROISIN INTERNATIONAL CO., LTD. SALICYLIC ACID 11.9 mg/21 E 20171231 69267-101_057842c3-d85b-3282-e054-00144ff88e88 69267-101 HUMAN PRESCRIPTION DRUG Atenolol Scopolamine Atenolol Scopolamine TABLET BUCCAL; ORAL; SUBLINGUAL; TRANSMUCOSAL 20141001 UNAPPROVED DRUG OTHER TPS ATENOLOL; SCOPOLAMINE HYDROBROMIDE 25; .25 mg/25.25mg; mg/25.25mg Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 69267-102_05797362-8cc2-35b7-e054-00144ff88e88 69267-102 HUMAN PRESCRIPTION DRUG Atenolol Scopolamine Atenolol Scopolamine TABLET ORAL 20141001 UNAPPROVED DRUG OTHER TPS ATENOLOL; SCOPOLAMINE HYDROBROMIDE 50; .5 mg/50.5mg; mg/50.5mg Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 69267-201_0579a12e-690c-3fa0-e054-00144ff88e88 69267-201 HUMAN PRESCRIPTION DRUG Propranolol Scopolamine Propranolol Scopolamine TABLET ORAL 20141001 UNAPPROVED DRUG OTHER TPS SCOPOLAMINE HYDROBROMIDE; PROPRANOLOL HYDROCHLORIDE .25; 20 mg/20.25mg; mg/20.25mg Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 69267-202_05797362-8cc7-35b7-e054-00144ff88e88 69267-202 HUMAN PRESCRIPTION DRUG Propranolol Scopolamine Propranolol Scopolamine TABLET ORAL 20141001 UNAPPROVED DRUG OTHER TPS PROPRANOLOL HYDROCHLORIDE; SCOPOLAMINE HYDROBROMIDE 40; .5 mg/40.5mg; mg/40.5mg Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 69269-106_60b418a3-5276-4549-99cc-294c69fea1b9 69269-106 HUMAN PRESCRIPTION DRUG Obagi - C HYDROQUINONE LIQUID TOPICAL 20141001 UNAPPROVED DRUG OTHER YS PLUS CORPORATION HYDROQUINONE 40 mg/mL Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 69274-001_08b1f358-f446-5080-e054-00144ff8d46c 69274-001 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50% Isopropyl Alcohol LIQUID TOPICAL 20141125 OTC MONOGRAPH NOT FINAL part333A FOUR SEASONS TRADING INC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 69274-002_08b28434-5da3-54b9-e054-00144ff88e88 69274-002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50% with Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20141125 OTC MONOGRAPH NOT FINAL part333A FOUR SEASONS TRADING INC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 69274-003_08b28434-5db7-54b9-e054-00144ff88e88 69274-003 HUMAN OTC DRUG Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20141125 OTC MONOGRAPH NOT FINAL part348 FOUR SEASONS TRADING INC CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.7; 1; 1 g/100g; g/100g; g/100g N 20181231 69274-004_08b343dd-3ca9-6ff6-e054-00144ff88e88 69274-004 HUMAN OTC DRUG Blue Ice Topical Analgesic Menthol and Camphor GEL TOPICAL 20141125 OTC MONOGRAPH NOT FINAL part348 FOUR SEASONS TRADING INC MENTHOL; CAMPHOR (SYNTHETIC) 1; .5 g/100g; g/100g N 20181231 69276-200_513e0139-2667-07cb-e054-00144ff8d46c 69276-200 HUMAN OTC DRUG Brioschi Effervescent Antacid Sodium bicarbonate GRANULE, EFFERVESCENT ORAL 20170605 OTC MONOGRAPH FINAL part331 Neobourne Pharma LP SODIUM BICARBONATE 1.02 g/5g N 20181231 69276-200_5efce361-3538-6c95-e053-2991aa0aba24 69276-200 HUMAN OTC DRUG Brioschi Effervescent Antacid Sodium bicarbonate GRANULE, EFFERVESCENT ORAL 20171127 OTC MONOGRAPH FINAL part331 Neobourne Pharma LP SODIUM BICARBONATE 1.02 g/5g N 20181231 69277-6132_21fda613-cc15-34c8-e054-00144ff88e88 69277-6132 HUMAN OTC DRUG Medicated Bandage Witch Hazel TAPE TOPICAL 20151015 OTC MONOGRAPH FINAL part347 Aid Tec Inc. WITCH HAZEL 88.2 g/100g E 20171231 69278-001_6357a81a-6e7b-3c07-e053-2991aa0a94e4 69278-001 HUMAN OTC DRUG Dr.zium All Clear Spot Salicylic acid CREAM TOPICAL 20180117 OTC MONOGRAPH FINAL part333D GM Holdings Co., Ltd SALICYLIC ACID .00001 g/100mL N 20191231 69278-100_c1513101-e753-42e4-ade4-13e653e48c4a 69278-100 HUMAN OTC DRUG Dr Cellapy SR Premium ascorbic acid KIT 20141010 UNAPPROVED DRUG OTHER GM Holdings Co., Ltd N 20181231 69278-103_90904d1a-0be8-4337-932f-91c84cb0441f 69278-103 HUMAN OTC DRUG Cellapy A Repair Cream Ceramide 3 CREAM TOPICAL 20141015 UNAPPROVED DRUG OTHER GM Holdings Co., Ltd CERAMIDE 3 .1 1/100mL N 20181231 69278-104_e80a9aaa-9240-4048-a38f-f421c6e72c55 69278-104 HUMAN OTC DRUG Cellapy A Repair Ceramide 3 LOTION TOPICAL 20141022 UNAPPROVED DRUG OTHER GM Holdings Co., Ltd CERAMIDE 3 .05 1/200mL N 20181231 69278-105_9742929c-d8a3-49d3-a7e9-d4d8c390277e 69278-105 HUMAN OTC DRUG Cellapy MGF Hydro Gel Intense Mask Allantoin PATCH TOPICAL 20141022 OTC MONOGRAPH FINAL part347 GM Holdings Co., Ltd ALLANTOIN .5 1/25g N 20181231 69278-106_8876e9fd-8eae-403c-a910-1a760d8cca20 69278-106 HUMAN OTC DRUG Cellapy Haircell Meso Tonic Panthenol, Salyclic Acid, Menthol LIQUID TRANSDERMAL 20160304 UNAPPROVED DRUG OTHER Gm Holdings Co., Ltd SALICYLIC ACID; PANTHENOL; MENTHOL .001; .001; .001 1/150mL; 1/150mL; 1/150mL N 20181231 69278-107_2b300b0b-4a75-4df9-9fde-7144fd4906ab 69278-107 HUMAN OTC DRUG Cellapy Haircell Salicylic Acid, Niacinamide, Panthenol, Menthol SHAMPOO TOPICAL 20160304 UNAPPROVED DRUG OTHER Gm Holdings Co., Ltd SALICYLIC ACID; NIACINAMIDE; PANTHENOL; MENTHOL .001; .001; .001; .001 1/300mL; 1/300mL; 1/300mL; 1/300mL N 20181231 69278-108_9cc6e5ce-f074-4857-acda-700a7c601c78 69278-108 HUMAN OTC DRUG Cellapy A.Repair Plus Niacinamide, Dimethicone, Panthenol CREAM TOPICAL 20170104 UNAPPROVED DRUG OTHER Gm Holdings Co., Ltd NIACINAMIDE; DIMETHICONE; PANTHENOL 1; .85; .1 g/50mL; g/50mL; g/50mL N 20181231 69279-144_5ab4aab6-1c33-48e4-9ca9-4c18a70ed8fe 69279-144 HUMAN OTC DRUG RETADOLOR Pain Relief Capsaicin CREAM TOPICAL 20150807 OTC MONOGRAPH NOT FINAL part348 LACAR SALES & MARKETING INC. CAPSAICIN .25 mg/g N 20181231 69279-241_226dbfdf-95be-4082-a8d4-be72c4b1392e 69279-241 HUMAN OTC DRUG Retadolor MENTHOL, UNSPECIFIED FORM and CAMPHOR (SYNTHETIC) CREAM TOPICAL 20170208 OTC MONOGRAPH NOT FINAL part348 LACAR SALES & MARKETING INC. MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC) .12; .06 g/g; g/g N 20181231 69281-010_4900940f-db08-4b55-aa1b-600920ea4eb6 69281-010 HUMAN OTC DRUG DHT X TONIC OATMEAL SOLUTION TOPICAL 20141001 OTC MONOGRAPH FINAL part347 IDOOGEN CO., LTD. OATMEAL .003 mg/55mL N 20181231 69281-020_d7d315aa-12a6-4001-a323-2780ddecae42 69281-020 HUMAN OTC DRUG DHT X OATMEAL SHAMPOO TOPICAL 20141001 OTC MONOGRAPH FINAL part347 IDOOGEN CO., LTD. OATMEAL .025 g/360g N 20181231 69281-030_3297e9a9-e215-487d-8e88-22e117469ca9 69281-030 HUMAN OTC DRUG DHT X HAIRLOSS Niacinamide SHAMPOO TOPICAL 20141101 UNAPPROVED DRUG OTHER IDOOGEN CO., LTD. NIACINAMIDE 1.08 g/360g N 20181231 69281-040_2825ddd9-6b8e-4018-9061-a4e2c368ed59 69281-040 HUMAN OTC DRUG DHT X SCALP T Niacinamide SHAMPOO TOPICAL 20141201 UNAPPROVED DRUG OTHER IDOOGEN CO., LTD. NIACINAMIDE 1.2 mg/400mL N 20181231 69282-001_86b0af44-48f7-4fcc-b6c0-731ce46f0ec9 69282-001 HUMAN OTC DRUG Nioxin Hair Regrowth Treatment for Women Minoxidil SOLUTION TOPICAL 20141101 ANDA ANDA075357 The Wella Corporation MINOXIDIL 2 g/100mL N 20181231 69282-002_0e228336-a1b0-4bd4-b66c-0a1da606f1eb 69282-002 HUMAN OTC DRUG Nioxin Hair Regrowth Treatment Extra Strength for Men Minoxidil SOLUTION TOPICAL 20141101 ANDA ANDA075357 The Wella Corporation MINOXIDIL 5 g/100mL N 20181231 69282-003_ffe33676-62ff-408a-afd0-f6af95bc0fb3 69282-003 HUMAN OTC DRUG Nioxin Scalp Optimizing Conditioner Advanced Thinning Pyrithione Zinc LOTION TOPICAL 20141110 OTC MONOGRAPH FINAL part358H The Wella Corporation PYRITHIONE ZINC .5 g/100mL N 20181231 69282-004_bded8ad1-8ffb-411a-bd72-b4dc3e331ef1 69282-004 HUMAN OTC DRUG Nioxin Scalp Optimizing Cleanser Advanced Thinning Pyrithione Zinc SHAMPOO TOPICAL 20141110 OTC MONOGRAPH FINAL part358H The Wella Corporation PYRITHIONE ZINC 1 g/100mL N 20181231 69282-005_8b4d3c75-162c-43de-b5fd-7370639ff737 69282-005 HUMAN OTC DRUG Nioxin Scalp Recovery Medicating Cleanser Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20160701 OTC MONOGRAPH FINAL part358H The Wella Corporation PYRITHIONE ZINC 1 g/100mL N 20181231 69282-006_bb939a13-13a5-4153-b3be-9610e9744ec8 69282-006 HUMAN OTC DRUG Nioxin Scalp Recovery Soothing Serum Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20160701 OTC MONOGRAPH FINAL part358H The Wella Corporation PYRITHIONE ZINC .1 g/100mL N 20181231 69282-007_8b7c00eb-fe06-4192-aedf-c2379ff76c23 69282-007 HUMAN OTC DRUG Nioxin Scalp Recovery Medicating Cleanser Pyrithione Zinc LOTION TOPICAL 20160701 OTC MONOGRAPH FINAL part358H The Wella Corporation PYRITHIONE ZINC .5 g/100mL N 20181231 69286-001_57a9129e-c7df-4e03-9af3-8b84f0a21835 69286-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20141014 NDA NDA205849 Advantage Respiratory Services OXYGEN 900 mL/L N 20181231 69288-001_ab5a9756-1232-48bf-bb5d-e03948c609cf 69288-001 HUMAN OTC DRUG NDM SCALP Biotin, Nicotinamide, DPanthenol, Pyrithione Zinc SHAMPOO TOPICAL 20141027 UNAPPROVED DRUG OTHER Damomedical Ltd. BIOTIN; PYRITHIONE ZINC; NIACINAMIDE; DEXPANTHENOL .168; .168; .84; 1.4 g/280mL; g/280mL; g/280mL; g/280mL E 20171231 69288-002_980b8f7a-5108-4972-9b07-e35109d33c2e 69288-002 HUMAN OTC DRUG NDM SCALP Tonic Salicylic Acid, Nicotinamide LIQUID TOPICAL 20141027 UNAPPROVED DRUG OTHER Damomedical Ltd. SALICYLIC ACID; NIACINAMIDE .45; .27 g/90mL; g/90mL E 20171231 69290-140_431e550e-3a78-4295-8783-6262a3147eae 69290-140 HUMAN OTC DRUG Love and Beauty Coconut Vanilla Essence Antibacterial Scented Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part333E Forever 21 ALCOHOL 17.98 mL/29mL N 20181231 69290-141_c113a509-12b8-49c5-90c8-e11f433222c0 69290-141 HUMAN OTC DRUG Love and Beauty Floral Rose Essence Antibacterial Scented Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part333E Forever 21 ALCOHOL 17.98 mL/29mL N 20181231 69290-142_787a9514-fcdc-485e-ab15-db32659887ff 69290-142 HUMAN OTC DRUG Love and Beauty Grapefruit Citrus Essence Antibacterial Scented Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part333E Forever 21 ALCOHOL 17.98 mL/29mL N 20181231 69290-143_2c2cefc5-025e-49c5-b4ac-c6108107e355 69290-143 HUMAN OTC DRUG Love and Beauty Lemon Fresh Essence Antibacterial Scented Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part333E Forever 21 ALCOHOL 17.98 mL/29mL N 20181231 69290-144_b58ac9b7-1248-4e13-874d-b8b5fe83967a 69290-144 HUMAN OTC DRUG Love and Beauty Sweet Berry Essence Antibacterial Scented Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20141017 OTC MONOGRAPH NOT FINAL part333E Forever 21 ALCOHOL 17.98 mL/29mL N 20181231 69291-0850_5d67ccc0-6b15-f8f8-e053-2a91aa0a5630 69291-0850 HUMAN OTC DRUG NewGel Plus SPF Zinc Oxide, Sunscreen GEL TOPICAL 20160801 OTC MONOGRAPH FINAL part352 Newmedical Technology, Inc. ZINC OXIDE 20 g/100g N 20181231 69291-6215_486c4a51-9ece-3999-e054-00144ff8d46c 69291-6215 HUMAN OTC DRUG Silagen Zinc Oxide, Sunscreen GEL TOPICAL 20150601 OTC MONOGRAPH FINAL part352 NewMedical Technology Inc. ZINC OXIDE 20 g/100g N 20181231 69291-6230_486c4a51-9ece-3999-e054-00144ff8d46c 69291-6230 HUMAN OTC DRUG Silagen Zinc Oxide, Sunscreen GEL TOPICAL 20150601 OTC MONOGRAPH FINAL part352 NewMedical Technology Inc. ZINC OXIDE 20 g/100g N 20181231 69292-015_07e9f59a-60e8-4f3e-a15c-300d330bd2a6 69292-015 HUMAN PRESCRIPTION DRUG ganciclovir ganciclovir GEL OPHTHALMIC 20170908 NDA AUTHORIZED GENERIC NDA022211 Amici Pharmaceuticals LLC GANCICLOVIR 1.5 mg/g Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC] N 20181231 69293-565_d34f72fd-4ef7-44fa-9fed-d3e4d12f4dc4 69293-565 HUMAN OTC DRUG Migrenol Acetaminophen, Caffeine TABLET ORAL 20141110 OTC MONOGRAPH NOT FINAL part343 Four Ventures Enterprises, Inc. ACETAMINOPHEN; CAFFEINE 500; 6 mg/1; mg/1 N 20181231 69294-1001_9980f7cd-f70b-46a2-b03b-5a52a3122da0 69294-1001 HUMAN OTC DRUG JINHANCHO SALICYLIC ACID SHAMPOO TOPICAL 20141017 OTC MONOGRAPH FINAL part358H The Anna SALICYLIC ACID .5 g/100mL E 20171231 69296-005_279662c7-51ef-44cd-a002-04bc95049566 69296-005 HUMAN PRESCRIPTION DRUG ROXYBOND oxycodone hydrochloride TABLET, COATED ORAL 20171001 NDA NDA209777 Inspirion Delivery Sciences Llc OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 69296-006_279662c7-51ef-44cd-a002-04bc95049566 69296-006 HUMAN PRESCRIPTION DRUG ROXYBOND oxycodone hydrochloride TABLET, COATED ORAL 20171001 NDA NDA209777 Inspirion Delivery Sciences Llc OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 69296-007_279662c7-51ef-44cd-a002-04bc95049566 69296-007 HUMAN PRESCRIPTION DRUG ROXYBOND oxycodone hydrochloride TABLET, COATED ORAL 20171001 NDA NDA209777 Inspirion Delivery Sciences Llc OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 69297-000_8ea5587b-2e5f-4c89-8ba5-04d94eb8eaa0 69297-000 HUMAN OTC DRUG Oral7 SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20150201 OTC MONOGRAPH FINAL part355 JCEC Company, Inc. SODIUM MONOFLUOROPHOSPHATE 1.4 mg/g E 20171231 69299-101_a6a4d99b-290f-41c3-91d5-7375dccf096b 69299-101 HUMAN OTC DRUG QUICK DRY ACNE TREATMENT SULFUR LOTION TOPICAL 20141117 OTC MONOGRAPH FINAL part333D DR. THROWER'S SKINCARE, INC. SULFUR 10 g/100mL E 20171231 69299-102_1c7a8fc1-a442-47b5-8908-c0c85ee78848 69299-102 HUMAN PRESCRIPTION DRUG DR. THROWERS HYDROTET TRETINOIN, HYDROCORTISONE CREAM TOPICAL 20150515 UNAPPROVED DRUG OTHER DR. THROWER'S SKINCARE, INC. TRETINOIN; HYDROCORTISONE .05; 1 g/100g; g/100g Retinoid [EPC],Retinoids [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 69299-103_d96e1d85-2df1-4951-9784-c9474eafdc67 69299-103 HUMAN PRESCRIPTION DRUG DR. THROWERS BPO 5 BENZOYL PEROXIDE CREAM TOPICAL 20150515 UNAPPROVED DRUG OTHER DR. THROWER'S SKINCARE, INC. BENZOYL PEROXIDE 5 g/100g E 20171231 69299-201_23c65bcf-e8e9-4ebb-a2df-0424788b6d34 69299-201 HUMAN PRESCRIPTION DRUG DR. THROWERS BETA BETAMETHASONE DIPROPIONATE CREAM TOPICAL 20150515 UNAPPROVED DRUG OTHER DR. THROWER'S SKINCARE, INC. BETAMETHASONE DIPROPIONATE .05 g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 69299-202_bf100fa3-779f-45b5-8d9b-c7c7012b3b7d 69299-202 HUMAN PRESCRIPTION DRUG DR. THROWERS BETA BETAMETHASONE OINTMENT TOPICAL 20150515 UNAPPROVED DRUG OTHER DR. THROWER'S SKINCARE, INC. BETAMETHASONE .05 g/100g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 69299-301_615c0835-e631-4e35-8d48-e3bcddf3ef0e 69299-301 HUMAN PRESCRIPTION DRUG DR. THROWERS PBC NO. 1 HYDROQUINONE, TRETINOIN, BETAMETHASONE DIPROPIONATE CREAM TOPICAL 20150515 UNAPPROVED DRUG OTHER DR. THROWER'S SKINCARE, INC. HYDROQUINONE; TRETINOIN; BETAMETHASONE DIPROPIONATE 12; .1; .5 g/100g; g/100g; g/100g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Retinoid [EPC],Retinoids [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 69299-302_b0fb65e3-621d-4c67-b64c-7b06a4bfcf52 69299-302 HUMAN OTC DRUG DR. THROWERS SKIN LIGHTENING MOISTURIZING HYDROQUINONE LOTION TOPICAL 20150515 OTC MONOGRAPH NOT FINAL part358A DR. THROWER'S SKINCARE, INC. HYDROQUINONE 2 g/100mL E 20171231 69301-001_1bc12706-0162-4d1b-baad-1f48d8dcf1c7 69301-001 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g N 20181231 69301-002_1900103a-ead3-4014-a8aa-ba97e8ee42af 69301-002 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g N 20181231 69301-003_4683cc91-de95-48cf-9871-8d50e891ca99 69301-003 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g N 20181231 69301-004_fe5baaa6-46d5-446f-832b-8e700da766d7 69301-004 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g N 20181231 69301-005_3ea005c5-1310-4a76-ab28-8f176b6e16d5 69301-005 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g N 20181231 69301-006_e31f694d-7325-4c5d-a2e7-38b58caa2f0d 69301-006 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g N 20181231 69301-007_728c98a5-1571-492e-8a85-17fa40655bcb 69301-007 HUMAN OTC DRUG Top Quality Mfg. Topical Anesthetic Benzocaine GEL DENTAL 20140501 OTC MONOGRAPH NOT FINAL part356 Top Quality Manufacturing, Inc. BENZOCAINE 200 mg/g N 20181231 69301-025_84d9e7b5-782f-4acf-8c81-89b5d976e9fd 69301-025 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69301-026_1abc6325-74bf-43e5-ba36-ca457c9140e8 69301-026 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69301-027_debbe58e-855e-4d1b-858a-9f4204a5aaec 69301-027 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69301-028_1e7d0fa5-f767-4ac3-b363-1107102cd6f5 69301-028 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69301-029_2619b384-ffdb-47f7-a542-6b70c650ffbb 69301-029 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69301-030_bd7bdeb6-336c-4259-8fc1-52ddb886781d 69301-030 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69301-031_98e5449e-7639-4a46-a805-29daa5633656 69301-031 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69301-032_4569cb4c-0d8a-408f-b053-89ac5f7cca44 69301-032 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69301-033_1ad15788-4b5b-49a1-8103-ad11c23d89bc 69301-033 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69301-034_36dd5c7c-30c6-43e8-bcc5-3f1c14deea07 69301-034 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride GEL DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69301-050_644c66d1-27b7-4fe8-8686-c527298eb638 69301-050 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 1.5375 g/125g E 20171231 69301-051_d348f3f1-d867-4922-bfff-d2236c0ef153 69301-051 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 1.5375 g/125g E 20171231 69301-052_af95ce5b-a593-4a9d-b13e-e9515fc06d60 69301-052 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 1.5375 g/125g E 20171231 69301-053_55d1df94-64fd-4bcb-80b5-e2452c0235f3 69301-053 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 1.5375 g/125g E 20171231 69301-054_f386db71-9d5e-4e70-b954-2e68a9cdba08 69301-054 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 1.5375 g/125g E 20171231 69301-055_3b6588fa-38c5-4cde-9abe-481e9bb38b8e 69301-055 HUMAN PRESCRIPTION DRUG Top Quality Mfg APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140501 UNAPPROVED DRUG OTHER Top Quality Manufacturing, Inc. SODIUM FLUORIDE 1.5375 g/125g E 20171231 69302-100_050b33b0-7817-49c7-94e8-92e9dfe0a8ef 69302-100 HUMAN OTC DRUG Bliss Mad About Smooth Smoothing Mineral Primer Broad Spectrum SPF 15 Sunscreen TITANIUM DIOXIDE CREAM TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part352 HatchBeauty Labs, LLC TITANIUM DIOXIDE 69 mg/mL E 20171231 69302-200_0086ed5b-7a76-4ecb-8bb1-b1cc1d02e014 69302-200 HUMAN OTC DRUG bliss just a little tint oil-free tinted moisturizer broad spectrum SPF 20 sunscreen - Porcelain TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part352 HatchBeauty Labs, LLC TITANIUM DIOXIDE; ZINC OXIDE 63; 59 mg/mL; mg/mL E 20171231 69302-201_576fdb51-4dce-414b-9ef6-7e79e2af9874 69302-201 HUMAN OTC DRUG bliss just a little tint oil-free tinted moisturizer broad spectrum SPF 20 sunscreen - Natural TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part352 HatchBeauty Labs, LLC TITANIUM DIOXIDE; ZINC OXIDE 63; 59 mg/mL; mg/mL E 20171231 69302-202_369206b8-046b-4970-aa62-6c96d2a90b09 69302-202 HUMAN OTC DRUG bliss just a little tint oil-free tinted moisturizer broad spectrum SPF 20 sunscreen - Nude TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part352 HatchBeauty Labs, LLC TITANIUM DIOXIDE; ZINC OXIDE 63; 59 mg/mL; mg/mL E 20171231 69302-203_a8214651-5b84-47b0-9295-0b15c0f60f81 69302-203 HUMAN OTC DRUG bliss just a little tint oil-free tinted moisturizer broad spectrum SPF 20 sunscreen - Sand TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part352 HatchBeauty Labs, LLC TITANIUM DIOXIDE; ZINC OXIDE 63; 59 mg/mL; mg/mL E 20171231 69302-204_fe6b74ca-2a71-4b5c-a5e6-cf1b318d1b8b 69302-204 HUMAN OTC DRUG bliss just a little tint oil-free tinted moisturizer broad spectrum SPF 20 sunscreen - Honey TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part352 HatchBeauty Labs, LLC TITANIUM DIOXIDE; ZINC OXIDE 63; 59 mg/mL; mg/mL E 20171231 69302-205_effde11d-e72d-4c8d-9b65-a52158759210 69302-205 HUMAN OTC DRUG bliss just a little tint oil-free tinted moisturizer broad spectrum SPF 20 sunscreen - Almond TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part352 HatchBeauty Labs, LLC TITANIUM DIOXIDE; ZINC OXIDE 63; 59 mg/mL; mg/mL E 20171231 69302-206_01c981a0-5a29-4e4a-b0b8-2e2182432a51 69302-206 HUMAN OTC DRUG bliss just a little tint oil-free tinted moisturizer broad spectrum SPF 20 sunscreen - Bronze TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part352 HatchBeauty Labs, LLC TITANIUM DIOXIDE; ZINC OXIDE 63; 59 mg/mL; mg/mL E 20171231 69302-207_a47358f0-372a-4525-b648-1f042056a1f1 69302-207 HUMAN OTC DRUG bliss just a little tint oil-free tinted moisturizer broad spectrum SPF 20 sunscreen - Espresso TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part352 HatchBeauty Labs, LLC TITANIUM DIOXIDE; ZINC OXIDE 63; 59 mg/mL; mg/mL E 20171231 69303-630_f3a56588-7965-4a55-83b6-a46a245dbe3c 69303-630 HUMAN OTC DRUG The Organic Pharmacy Cellular Protection Sunscreen SPF 30 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140715 OTC MONOGRAPH NOT FINAL part352 The organic pharmacy TITANIUM DIOXIDE; ZINC OXIDE 1; 10 g/100g; g/100g E 20171231 69303-650_f3a56588-7965-4a55-83b6-a46a245dbe3c 69303-650 HUMAN OTC DRUG The Organic Pharmacy Cellular Protection Sunscreen SPF 50 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140715 OTC MONOGRAPH NOT FINAL part352 The organic pharmacy TITANIUM DIOXIDE; ZINC OXIDE 1; 12.5 g/100g; g/100g E 20171231 69304-002_2c1636fa-a689-3bf1-e054-00144ff88e88 69304-002 HUMAN OTC DRUG Antibacterial Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20160218 OTC MONOGRAPH NOT FINAL part333A Lin’an Jiameihui Cleaning Co., Ltd. BENZALKONIUM CHLORIDE .1 g/100g E 20171231 69305-000_62c2e599-0ab2-6434-e053-2a91aa0adcc8 69305-000 HUMAN OTC DRUG Prolongz Damiana, Ginseng STRIP ORAL 20141024 UNAPPROVED HOMEOPATHIC Advanced Men's Institute LLC TURNERA DIFFUSA LEAF; ASIAN GINSENG 1; 1 [hp_X]/1001; [hp_X]/1001 N 20191231 69305-002_629b4c3c-9b62-2e80-e053-2991aa0aaaac 69305-002 HUMAN OTC DRUG TBX-Free Laburnum anagyroides STRIP ORAL 20160419 UNAPPROVED HOMEOPATHIC Advanced Men’s Institute LLC LABURNUM ANAGYROIDES FLOWERING TOP 1 [hp_X]/10[hp_X] N 20191231 69307-1024_549c9690-ffa4-509d-e054-00144ff88e88 69307-1024 HUMAN PRESCRIPTION DRUG Vanilla SilQ Barium Sulfate SUSPENSION ORAL 20141027 UNAPPROVED DRUG OTHER Genus Medical Technologies, LLC BARIUM SULFATE 21 mg/mL Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 69307-4096_549c92e1-113c-0203-e054-00144ff8d46c 69307-4096 HUMAN PRESCRIPTION DRUG Vanilla SilQ MD Barium Sulfate For Suspension POWDER, FOR SUSPENSION ORAL; RECTAL 20150601 UNAPPROVED DRUG OTHER Genus Medical Technologies, LLC BARIUM SULFATE 96 g/100g Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 69307-4496_549b7c13-569e-512d-e054-00144ff8d46c 69307-4496 HUMAN PRESCRIPTION DRUG Vanilla SilQ HD Barium Sulfate For Suspension POWDER, FOR SUSPENSION ORAL; RECTAL 20151208 UNAPPROVED DRUG OTHER Genus Medical Technologies, LLC BARIUM SULFATE 98 g/100g Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] N 20181231 69308-000_12d8696b-8ddb-4e17-abf7-0f093a59c3d7 69308-000 HUMAN OTC DRUG Prolongz Damiana, Ginseng STRIP ORAL 20141024 UNAPPROVED HOMEOPATHIC Guangdong Classic Health-Care Products Co., Ltd. TURNERA DIFFUSA LEAF; ASIAN GINSENG 1; 1 [hp_X]/1001; [hp_X]/1001 E 20171231 69309-1001_5b889b18-4310-44f4-8294-2b99e5a8235e 69309-1001 HUMAN OTC DRUG MIRACLE ATO GLYCERIN CREAM TOPICAL 20141022 OTC MONOGRAPH FINAL part347 Dr. Ha Skin Lab Co. GLYCERIN 2 g/100mL E 20171231 69309-2001_7a72f61b-3778-47fd-b7aa-795eda6c8d3f 69309-2001 HUMAN OTC DRUG REMEMBER SERUM GLYCERIN LIQUID TOPICAL 20141022 OTC MONOGRAPH FINAL part347 Dr. Ha Skin Lab Co. GLYCERIN 2 g/100mL E 20171231 69311-0001_96057ec7-68ee-4c08-8963-4b5b98638635 69311-0001 HUMAN OTC DRUG WEIGHT MANAGEMENT SUPPORT Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Brain (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), Aacg-A, Aacg-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto Dhea (Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum, Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20150217 UNAPPROVED HOMEOPATHIC Lifetime Fat Loss Centers CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 69311-0002_943ca64e-61e7-4482-92ca-72795425dbd6 69311-0002 HUMAN OTC DRUG Weight Management Support Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Brain (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), Aacg-A, Aacg-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto (3-Acetyl-7-Oxo-Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum, Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20150701 20200925 UNAPPROVED HOMEOPATHIC Lifetime Fat Loss Centers CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; PORK BRAIN; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 69311-0003_e19f3c26-1102-467d-bd21-8e63eee6edea 69311-0003 HUMAN OTC DRUG Detox Beta Vulgaris, Boldo, Chelidonium Majus, Sarsaparilla (Smilax Regelii), Gelsemium Sempervirens, Veratrum Album, Ferrum Metallicum, Iodium, Lycopodium Clavatum, Nux Vomica, Pulsatilla (Vulgaris), Selenium Metallicum, Thuja Occidentalis, Zincum Metallicum LIQUID ORAL 20150706 UNAPPROVED HOMEOPATHIC Lifetime Fat Loss Centers BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; SMILAX REGELII ROOT; GELSEMIUM SEMPERVIRENS ROOT; VERATRUM ALBUM ROOT; IRON; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SELENIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 3; 3; 3; 6; 7; 7; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69311-0004_5f2c96c5-bbcd-4ffe-81d4-7fe8ff17ca81 69311-0004 HUMAN OTC DRUG Weight Management Support Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Cerebrum (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), Aacg-A, Aacg-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto (3-Acetyl-7-Oxo-Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum, Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20160229 20210510 UNAPPROVED HOMEOPATHIC Lifetime Fat Loss Centers CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; SUS SCROFA CEREBRUM; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 69311-0005_0504b68b-8133-4c62-9718-98574e440982 69311-0005 HUMAN OTC DRUG Weight Management Support Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Cerebrum (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), Aacg-A, Aacg-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto (3-Acetyl-7-Oxo-Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum, Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20160623 UNAPPROVED HOMEOPATHIC Lifetime Fat Loss Centers CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; SUS SCROFA CEREBRUM; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 69311-0006_05885b2c-d401-452f-988e-d07de3cfceb0 69311-0006 HUMAN OTC DRUG Detox Beta Vulgaris, Boldo, Chelidonium Majus, Sarsaparilla (Smilax Regelii), Gelsemium Sempervirens, Veratrum Album, Ferrum Metallicum, Iodium, Lycopodium Clavatum, Nux Vomica, Pulsatilla (Vulgaris), Selenium Metallicum, Thuja Occidentalis, Zincum Metallicum LIQUID ORAL 20170406 UNAPPROVED HOMEOPATHIC Lifetime Fat Loss Centers BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; SMILAX REGELII ROOT; GELSEMIUM SEMPERVIRENS ROOT; VERATRUM ALBUM ROOT; IRON; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SELENIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 3; 3; 3; 6; 7; 7; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69311-0007_ebebc7eb-dae9-4848-bd54-6ddcb9fea08d 69311-0007 HUMAN OTC DRUG Detox Beta vulg, Boldo, Chelidonium maj, Sarsaparilla, Gelsemium, Veratrum alb, Ferrum met, Iodium, Lycopodium, Nux vom, Pulsatilla, Selenium, Thuja occ, Zinc met LIQUID ORAL 20170403 UNAPPROVED HOMEOPATHIC Lifetime Fat Loss Centers BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; SMILAX ORNATA ROOT; GELSEMIUM SEMPERVIRENS ROOT; VERATRUM ALBUM ROOT; IRON; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SELENIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 3; 3; 3; 6; 7; 7; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 69311-0008_6cb07250-28f4-465f-af2c-e3a72f763e40 69311-0008 HUMAN OTC DRUG WEIGHT MANAGEMENT Asclepias vinc,Echinacea,Hypothalamus,Cerebrum suis,Hepar suis,Kidney,Methylcobalamin,Pancreas suis,Stomach suis,AACG-A,AACG-B,Calc carb,Gambogia,Gelsemium,Graphites,Nat mur,Nux vom,Phytolacca,3-acetyl-7-oxo-dehydroepiandrosterone,ATP,Glucagon,Insulinum,Sarcolacticum ac,Proteus. LIQUID ORAL 20170403 UNAPPROVED HOMEOPATHIC Lifetime Fat Loss Centers VINCETOXICUM HIRUNDINARIA ROOT; ECHINACEA, UNSPECIFIED; BOS TAURUS HYPOTHALAMUS; SUS SCROFA CEREBRUM; PORK LIVER; EUTROCHIUM PURPUREUM WHOLE; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL N 20181231 69312-001_0acfcbe9-b3a6-56e8-e054-00144ff8d46c 69312-001 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL 50% Isopropyl Alcohol LIQUID TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part333A CONVENIENT CASH AND CARRY INC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 69312-002_0a94f0c2-9982-2d45-e054-00144ff8d46c 69312-002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50% with Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part333A CONVENIENT CASH AND CARRY INC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 69312-003_0a9505ff-941c-14a3-e054-00144ff8d46c 69312-003 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70% Isopropyl Alcohol LIQUID TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part333A CONVENIENT CASH AND CARRY INC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 69312-004_0a94f0c2-9994-2d45-e054-00144ff8d46c 69312-004 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70% with Wintergreen Isopropyl Alcohol LIQUID TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part333A CONVENIENT CASH AND CARRY INC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 69312-005_0a94f4af-1621-4e62-e054-00144ff8d46c 69312-005 HUMAN OTC DRUG Vaporizing Chest Rub Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part348 CONVENIENT CASH AND CARRY INC CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.7; 1; 1 g/100g; g/100g; g/100g N 20181231 69312-006_0a94f4af-1630-4e62-e054-00144ff8d46c 69312-006 HUMAN OTC DRUG Blue Ice Topical Analgesic Menthol and Camphor GEL TOPICAL 20141219 OTC MONOGRAPH NOT FINAL part348 CONVENIENT CASH AND CARRY INC MENTHOL; CAMPHOR (SYNTHETIC) 1; .5 g/100g; g/100g N 20181231 69313-632_444511c6-ef0b-2d22-e054-00144ff8d46c 69313-632 HUMAN OTC DRUG LidoFLEX LidoFLEX Single Pouch, Back PATCH TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part348 NAIMCO, INC. DBA RICHMAR, INC. LIDOCAINE 29 mg/.24mg E 20171231 69313-633_444511c6-ef0b-2d22-e054-00144ff8d46c 69313-633 HUMAN OTC DRUG LidoFLEX Elbow, Single Pouch LidoFLEX Elbow PATCH TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part348 NAIMCO, INC. DBA RICHMAR, INC. LIDOCAINE 21.5 mg/.24mg E 20171231 69313-634_444511c6-ef0b-2d22-e054-00144ff8d46c 69313-634 HUMAN OTC DRUG LidoFLEX LidoFLEX Heel PATCH TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part348 NAIMCO, INC. DBA RICHMAR, INC. LIDOCAINE 22.7 mg/.24mg E 20171231 69313-635_444511c6-ef0b-2d22-e054-00144ff8d46c 69313-635 HUMAN OTC DRUG LidoFLEX LidoFLEX Single Pouch, Knee PATCH TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part348 NAIMCO, INC. DBA RICHMAR, INC. LIDOCAINE 25.8 mg/.24mg E 20171231 69313-636_444511c6-ef0b-2d22-e054-00144ff8d46c 69313-636 HUMAN OTC DRUG LidoFLEX LidoFLEX Shoulder PATCH TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part348 NAIMCO, INC. DBA RICHMAR, INC. LIDOCAINE 25.3 mg/.24mg E 20171231 69313-637_444511c6-ef0b-2d22-e054-00144ff8d46c 69313-637 HUMAN OTC DRUG LidoFLEX LidoFLEX Flex Strip Double PATCH TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part348 NAIMCO, INC. DBA RICHMAR, INC. LIDOCAINE 28.1 mg/.24mg E 20171231 69315-116_eb58f78b-0d8e-46aa-a9f6-c8fa93d30e63 69315-116 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Leading Pharma, LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 69315-117_eb58f78b-0d8e-46aa-a9f6-c8fa93d30e63 69315-117 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Leading Pharma, LLC FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 69315-118_eb58f78b-0d8e-46aa-a9f6-c8fa93d30e63 69315-118 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Leading Pharma, LLC FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 69315-127_bc9c52f0-7d32-432c-a28b-0ce95586c438 69315-127 HUMAN PRESCRIPTION DRUG Folic Acid FOLIC ACID TABLET ORAL 20090112 ANDA ANDA040796 Leading Pharma, LLC FOLIC ACID 1 mg/1 N 20181231 69315-130_308b563f-1646-437f-b03c-f300b35ac8e8 69315-130 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20070301 ANDA ANDA040702 Leading Pharma, LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69315-131_308b563f-1646-437f-b03c-f300b35ac8e8 69315-131 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20070301 ANDA ANDA040702 Leading Pharma, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69315-133_0e31973e-2b55-45da-9e03-e457dddcd0f6 69315-133 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20160407 ANDA ANDA040903 Leading Pharma, LLC IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69315-134_0e31973e-2b55-45da-9e03-e457dddcd0f6 69315-134 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20160407 ANDA ANDA040903 Leading Pharma, LLC IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69315-135_0e31973e-2b55-45da-9e03-e457dddcd0f6 69315-135 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20160407 ANDA ANDA040903 Leading Pharma, LLC IMIPRAMINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 69315-136_a898e6ea-748f-4fdc-b515-9004e7fede93 69315-136 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20121128 ANDA ANDA090168 Leading Pharma, LLC BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 69315-137_a898e6ea-748f-4fdc-b515-9004e7fede93 69315-137 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20121128 ANDA ANDA090168 Leading Pharma, LLC BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 69315-138_a898e6ea-748f-4fdc-b515-9004e7fede93 69315-138 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20121128 ANDA ANDA090168 Leading Pharma, LLC BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 69315-139_498bce66-6072-4212-8413-ff9888c58f9c 69315-139 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20160318 ANDA ANDA090195 Leading Pharma, LLC GLYCOPYRROLATE 1 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 69315-140_498bce66-6072-4212-8413-ff9888c58f9c 69315-140 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20160318 ANDA ANDA090195 Leading Pharma, LLC GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 69315-155_308b563f-1646-437f-b03c-f300b35ac8e8 69315-155 HUMAN PRESCRIPTION DRUG HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE TABLET ORAL 20161031 ANDA ANDA040702 Leading Pharma, LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69315-201_2774a2db-407b-40c0-b353-a857ceab9759 69315-201 HUMAN PRESCRIPTION DRUG Phentermine hydrochloride phentermine hydrochloride TABLET ORAL 20150602 ANDA ANDA205008 LEADING PHARMA, LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 69315-202_d686887d-38dd-4a64-8881-5ac8bd9de8e6 69315-202 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride phentermine hydrochloride CAPSULE ORAL 20150602 ANDA ANDA205019 LEADING PHARMA, LLC PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 69315-203_d686887d-38dd-4a64-8881-5ac8bd9de8e6 69315-203 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride phentermine hydrochloride CAPSULE ORAL 20150602 ANDA ANDA205019 LEADING PHARMA, LLC PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 69315-204_2774a2db-407b-40c0-b353-a857ceab9759 69315-204 HUMAN PRESCRIPTION DRUG Phentermine hydrochloride phentermine hydrochloride CAPSULE ORAL 20150602 ANDA ANDA205017 LEADING PHARMA, LLC PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 69315-205_b08d19f4-9001-49b8-b0b8-9c8fba197ce1 69315-205 HUMAN PRESCRIPTION DRUG SODIUM POLYSTYRENE SULFONATE sodium polystyrene sulfonate POWDER, FOR SUSPENSION ORAL; RECTAL 20150825 ANDA ANDA204071 LEADING PHARMA, LLC SODIUM POLYSTYRENE SULFONATE 4.1 meq/g E 20171231 69315-210_54702112-6d67-4ceb-89c8-db1e38d5bce0 69315-210 HUMAN PRESCRIPTION DRUG Methenamine Hippurate Methenamine Hippurate TABLET ORAL 20160603 NDA AUTHORIZED GENERIC NDA017681 Leading Pharma, LLC METHENAMINE HIPPURATE 1 g/1 N 20181231 69315-211_47048c9f-87d0-4626-9029-54c1589343ad 69315-211 HUMAN PRESCRIPTION DRUG NIFEDIPINE NIFEDIPINE CAPSULE ORAL 20161123 ANDA ANDA073250 Leading Pharma, LLC NIFEDIPINE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 69315-212_fd5d3311-f46d-4376-a4c1-bd8fa0eac057 69315-212 HUMAN PRESCRIPTION DRUG NIFEDIPINE NIFEDIPINE CAPSULE ORAL 20161123 ANDA ANDA074045 Leading Pharma, LLC NIFEDIPINE 20 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 69315-301_97a3ef32-4387-45ae-80b9-faceaf833a9c 69315-301 HUMAN OTC DRUG RectaSmoothe Lidocaine 5% CREAM TOPICAL 20110401 OTC MONOGRAPH FINAL part346 Leading Pharma, LLC LIDOCAINE 5 g/100g N 20181231 69315-302_d4bcf8db-c5e5-42d5-96b2-d5df7ed50555 69315-302 HUMAN PRESCRIPTION DRUG Procto-Med HC HYDROCORTISONE CREAM TOPICAL 20160509 ANDA ANDA089682 Leading Pharma, LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69315-501_9c3c666d-19b6-4313-a492-d16a0905d736 69315-501 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate Escitalopram SOLUTION ORAL 20150801 ANDA ANDA203967 Leading Pharma, LLC ESCITALOPRAM OXALATE 5 mg/5mL Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 69315-904_5ca13415-4b77-4131-a9d2-6db26bc49167 69315-904 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Leading Pharma, LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 69315-905_5ca13415-4b77-4131-a9d2-6db26bc49167 69315-905 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Leading Pharma, LLC LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 69315-906_5ca13415-4b77-4131-a9d2-6db26bc49167 69315-906 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20071001 ANDA ANDA078203 Leading Pharma, LLC LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 69316-321_756f7ec8-bd35-460b-9eb6-8a64f6b511db 69316-321 HUMAN OTC DRUG Mae by Damiva Calendula and Hamamelis SUPPOSITORY VAGINAL 20141110 UNAPPROVED HOMEOPATHIC Damiva Inc. CALENDULA OFFICINALIS FLOWER; HAMAMELIS VIRGINIANA LEAF 1; 6 [hp_X]/1; [hp_X]/1 N 20181231 69318-001_02133579-068a-40cf-a9e9-771d211334de 69318-001 HUMAN OTC DRUG AN12 Allantoin, Glycerin GEL TOPICAL 20141024 UNAPPROVED DRUG OTHER DoctorAN ALLANTOIN; GLYCERIN .3; 3 mg/150mL; mg/150mL E 20171231 69319-001_57c687c3-82ed-4066-9553-2178da695fb5 69319-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20141020 UNAPPROVED MEDICAL GAS Med Way Medical OXYGEN 99 L/100L E 20171231 69320-100_b50a1e42-2df7-4082-bfea-cbe7a2d6538e 69320-100 HUMAN OTC DRUG Arhtri Plus Menthol,Eucalyptus Oil,Clove Oil SPRAY TOPICAL 20141030 OTC MONOGRAPH NOT FINAL part348 Distributions Ar?mes d`Espagne Enr MENTHOL; EUCALYPTUS OIL; CLOVE OIL 2.5; .72; .25 g/100g; g/100g; g/100g E 20171231 69327-0101_1c3d27e1-1ab8-4787-9625-54feb1df1b33 69327-0101 HUMAN OTC DRUG Haesum Marine Fill Softner GLYCERIN LIQUID TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. GLYCERIN 5 g/100mL E 20171231 69327-1001_5457f375-87f9-4a74-ab2a-34961b28cd62 69327-1001 HUMAN OTC DRUG Fikia Marine Brightening Serum GLYCERIN LIQUID TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. GLYCERIN 2 g/100mL E 20171231 69327-1101_599809e1-6eaa-4424-bc51-af6e42ef6211 69327-1101 HUMAN OTC DRUG Haesum Marine Fill GLYCERIN LOTION TOPICAL 20150418 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. GLYCERIN 3 g/100mL E 20171231 69327-1201_3a61a09f-dd86-4148-affc-16d9a08af8d6 69327-1201 HUMAN OTC DRUG Haesum Marine Fill Serum GLYCERIN LIQUID TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. GLYCERIN 7 g/100mL E 20171231 69327-1301_8988f05d-90e7-486f-a409-2375815d54c1 69327-1301 HUMAN OTC DRUG Haesum Marine Fill GLYCERIN CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. GLYCERIN 10 g/100mL E 20171231 69327-2001_7ff2ee7c-cef6-4f78-92c2-50871b530fad 69327-2001 HUMAN OTC DRUG Fikia Marine Delight Soothing Mist ALLANTOIN LIQUID TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. ALLANTOIN .1 g/100mL E 20171231 69327-3001_89348ef4-5656-49ee-8ce6-17e609259c5c 69327-3001 HUMAN OTC DRUG Fikia Marine Eclipse Sun Block SPF 50 PA TITANIUM DIOXIDE CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part352 Beauty Line Co., Ltd. TITANIUM DIOXIDE 5 g/100mL E 20171231 69327-4001_b36f5003-4d52-4688-a38e-3f259eabf398 69327-4001 HUMAN OTC DRUG Fikia Marine Natural Sun BB SPF 50 PA TITANIUM DIOXIDE CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part352 Beauty Line Co., Ltd. TITANIUM DIOXIDE 7.5 g/100mL E 20171231 69327-5001_ea64286e-cc16-482f-9249-2b641d601bcd 69327-5001 HUMAN OTC DRUG Fikia Marine Velvet Whitening GLYCERIN CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. GLYCERIN 10 g/100mL E 20171231 69327-6001_08f6985a-3476-47b8-beee-99a8cddce1e1 69327-6001 HUMAN OTC DRUG M-Rose Seaweed Sun BB SPF 50 PA TITANIUM DIOXIDE CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part352 Beauty Line Co., Ltd. TITANIUM DIOXIDE 5.269 g/100mL E 20171231 69327-7001_661accce-3446-4ab4-b2c4-3b0db2173ae5 69327-7001 HUMAN OTC DRUG M-Rose Seaweed Lifting Revitalizing ALLANTOIN CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. ALLANTOIN 1 g/100mL E 20171231 69327-8001_e789c3dd-0256-41bf-a0c1-fda808b152af 69327-8001 HUMAN OTC DRUG M-Rose Seaweed Essence Serum ALLANTOIN CREAM TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. ALLANTOIN 1 g/100mL E 20171231 69327-9001_53c0f923-8980-4865-9f2a-a4e71e2fab77 69327-9001 HUMAN OTC DRUG M-Rose Seaweed Hydrogel Mask ALLANTOIN PATCH TOPICAL 20141025 OTC MONOGRAPH FINAL part347 Beauty Line Co., Ltd. ALLANTOIN .2 g/100g E 20171231 69329-002_081c276b-f716-081e-e054-00144ff88e88 69329-002 HUMAN OTC DRUG Lidonexe LIDOCAINE, MENTHOL PATCH TOPICAL 20141110 OTC MONOGRAPH NOT FINAL part348 Patchwerx Labs, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g E 20171231 69329-011_172e582c-7e77-38ac-e054-00144ff88e88 69329-011 HUMAN PRESCRIPTION DRUG Renuu NL ALLANTOIN, PETROLATUM PATCH TOPICAL 20140415 UNAPPROVED DRUG OTHER Patchwerx Labs ALLANTOIN; PETROLATUM 2; 30 g/100g; g/100g E 20171231 69329-012_1719195f-7e35-1489-e054-00144ff88e88 69329-012 HUMAN PRESCRIPTION DRUG Renuu Patch ALLANTOIN, LIDOCAINE, PETROLATUM PATCH TOPICAL 20140415 UNAPPROVED DRUG OTHER Patchwerx Labs ALLANTOIN; LIDOCAINE; PETROLATUM 2; 5; 30 g/100g; g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 69329-013_07eec701-f57a-7394-e054-00144ff88e88 69329-013 HUMAN OTC DRUG MENDEX MENTHOL, CAPSAICIN PATCH TOPICAL 20141110 OTC MONOGRAPH NOT FINAL part348 Patchwerx Labs, Inc MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g E 20171231 69329-017_07e9972b-b74c-4eb5-e054-00144ff88e88 69329-017 HUMAN PRESCRIPTION DRUG Lidenza Patch Lidocaine Hydrochloride PATCH TOPICAL 20131001 UNAPPROVED DRUG OTHER Patchwerx Labs, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 69329-025_07eaac2c-60ae-578b-e054-00144ff8d46c 69329-025 HUMAN PRESCRIPTION DRUG Releevia Menthol and Capsaicin PATCH TOPICAL 20141117 UNAPPROVED DRUG OTHER Patchwerx Labs, Inc MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g E 20171231 69329-030_10d1bcb7-c301-1145-e054-00144ff88e88 69329-030 HUMAN PRESCRIPTION DRUG Releevia MC Menthol and Capsaicin PATCH TOPICAL 20141117 UNAPPROVED DRUG OTHER Patchwerx Labs, Inc MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g E 20171231 69329-032_10d1bcb7-c2f4-1145-e054-00144ff88e88 69329-032 HUMAN PRESCRIPTION DRUG Releevia LM Patch Lidocaine Hydrochloride PATCH TOPICAL 20131001 UNAPPROVED DRUG OTHER Patchwerx Labs, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 69329-040_13cfbd7c-759c-73ca-e054-00144ff8d46c 69329-040 HUMAN OTC DRUG SCADEXE Allantoin, Lidocaine, Petrolatum PATCH TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part348 Patchwerx Labs, Inc. LIDOCAINE HYDROCHLORIDE; PETROLATUM; ALLANTOIN 4; 30; 2 g/100g; g/100g; g/100g E 20171231 69329-250_23d89b4f-da86-6b2c-e054-00144ff8d46c 69329-250 HUMAN PRESCRIPTION DRUG Dermasilkrx SDSpak Triamcinolone Acetonide Cream, Dimethicone Cream KIT 20150720 ANDA ANDA088042 Patchwerx Labs, Inc. E 20171231 69329-251_24381bab-d419-035b-e054-00144ff88e88 69329-251 HUMAN PRESCRIPTION DRUG NEWSDS pak Triamcinolone Acetonide Cream, Dimethicone Cream KIT 20151110 ANDA ANDA040671 Patchwerx Labs, Inc. E 20171231 69329-251_2474660b-176c-63aa-e054-00144ff88e88 69329-251 HUMAN PRESCRIPTION DRUG NEWSDS pak Triamcinolone Acetonide Cream, Dimethicone Cream KIT 20151110 ANDA ANDA040671 Patchwerx Labs, Inc. E 20171231 69329-260_2687330c-50dd-0339-e054-00144ff88e88 69329-260 HUMAN PRESCRIPTION DRUG Dermawerx Surgical PrePak chlorhexidine gluconate pre-surgical kit KIT TOPICAL 20151210 NDA NDA019125 Patchwerx Labs, Inc. E 20171231 69329-270_268023e4-43f1-3d4c-e054-00144ff8d46c 69329-270 HUMAN PRESCRIPTION DRUG Dermawerx Surgical Plus Pak Mupirocin Ointment Kit KIT TOPICAL 20151021 ANDA ANDA065123 Patchwerx Labs, Inc. E 20171231 69329-290_2b698784-a57f-0df4-e054-00144ff88e88 69329-290 HUMAN PRESCRIPTION DRUG Dermawerx SDS Pak Triamcinolone Acetonide Cream, Dimethicone Cream KIT 20150720 ANDA ANDA088042 Patchwerx Labs, Inc. E 20171231 69329-310_1b49bdfb-5232-7496-e054-00144ff8d46c 69329-310 HUMAN PRESCRIPTION DRUG DeramsilkRx Anodynexa Pak diclofenac sodium delayed release tablets, ranitidine tablets, capsaicin cream KIT 20150612 ANDA ANDA074514 Patchwerx Labs, Inc. E 20171231 69329-330_1c948de4-dbc1-309a-e054-00144ff8d46c 69329-330 HUMAN PRESCRIPTION DRUG DermasilkRx DicloPak diclofenac sodium delayed release tablets, ranitidine tablets, capsaicin cream KIT 20150805 ANDA ANDA074514 Patchwerx Labs, Inc. E 20171231 69329-335_1cc112b0-ac7f-3ecf-e054-00144ff88e88 69329-335 HUMAN PRESCRIPTION DRUG DermasilkRx DicloPak diclofenac sodium delayed release tablets, capsaicin cream KIT 20150806 ANDA ANDA074514 Patchwerx Labs, Inc. E 20171231 69329-510_2dd1e16d-c7dd-0eb6-e054-00144ff8d46c 69329-510 HUMAN PRESCRIPTION DRUG Diclotral Pak diclofenac sodium, capsaicin KIT TOPICAL 20140528 ANDA ANDA202027 Patchwerx Labs, Inc. E 20171231 69329-600_2468bf3e-e346-1d73-e054-00144ff8d46c 69329-600 HUMAN PRESCRIPTION DRUG DERMAWERX ZMT PAK ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, and TRETINOIN KIT 20150908 ANDA ANDA075264 Patchwerx Labs, Inc. N 20181231 69332-001_554fd11d-7a7f-0ba8-e054-00144ff8d46c 69332-001 HUMAN OTC DRUG Protection U.V. Broad Spectrum SPF 25 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20141102 OTC MONOGRAPH NOT FINAL part352 B.R. TITANIUM DIOXIDE; ZINC OXIDE 25; 38 mg/mL; mg/mL N 20181231 69335-001_ca41e282-80b8-42d7-bcc2-6cf01569ddd3 69335-001 HUMAN OTC DRUG Alpha BAC Stop E-2 CHLOROXYLENOL SOLUTION TOPICAL 20141104 OTC MONOGRAPH NOT FINAL part333A Alpha Chemical Services, Inc. CHLOROXYLENOL 1.5 g/100mL E 20171231 69335-002_455a6718-b1e2-47a1-9346-09b66f84ab4c 69335-002 HUMAN OTC DRUG Alpha E-3 Instant Hand Sanitizer Ethanol SPRAY TOPICAL 20141104 OTC MONOGRAPH NOT FINAL part333E Alpha Chemical Services, Inc. ALCOHOL 710 g/1000mL E 20171231 69336-101_456848c7-5e8b-44ca-8f6d-8d1ecd6464f9 69336-101 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20151223 ANDA ANDA077918 STERLING KNIGHT PHARMACEUTICALS, LLC MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69336-102_456848c7-5e8b-44ca-8f6d-8d1ecd6464f9 69336-102 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20100630 ANDA ANDA077918 STERLING KNIGHT PHARMACEUTICALS, LLC MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69336-103_c8fc057d-97ad-4340-866b-f7292310aeb3 69336-103 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20160815 ANDA ANDA206297 Sterling-Knight Pharmaceuticals, LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 69336-104_e49e22dc-5660-4d54-8a62-d0e04a7f1a99 69336-104 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride CAPSULE, FILM COATED, EXTENDED RELEASE ORAL 20161103 ANDA ANDA078218 Sterling Knight Pharmaceuticals,LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 69336-105_e49e22dc-5660-4d54-8a62-d0e04a7f1a99 69336-105 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride CAPSULE, FILM COATED, EXTENDED RELEASE ORAL 20161031 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals,LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 69336-106_57359554-b18c-42bc-9d15-b2265934eb7a 69336-106 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20161104 ANDA ANDA078428 Sterling Knight Pharmaceuticals,LLC GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69336-107_941762b8-d5ca-412c-99d4-e56dc9e2cd7b 69336-107 HUMAN PRESCRIPTION DRUG LANSOPRAZOLE LANSOPRAZOLE CAPSULE, DELAYED RELEASE ORAL 20161031 ANDA ANDA201921 Sterling Knight Pharmaceuticals LLC LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 69336-112_871465bc-55d1-4b4e-97d9-8591d705d78c 69336-112 HUMAN PRESCRIPTION DRUG Not Applicable omeprazole sodium bicarbonate CAPSULE ORAL 20170713 ANDA ANDA207476 Sterling Knight Pharmaceuticals LLC OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 69336-113_deb6dc29-c58d-4ee6-aa60-3a0436cc198a 69336-113 HUMAN PRESCRIPTION DRUG FENORTHO FENORTHO CAPSULE ORAL 20170321 NDA AUTHORIZED GENERIC NDA017604 Sterling Knight Pharmaceuticals LLC FENOPROFEN CALCIUM 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69336-118_6aedf2c8-9072-483e-ae55-faa1078491ad 69336-118 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20170328 UNAPPROVED DRUG OTHER Sterling-Knight Pharmaceuticals, LLC PHENOBARBITAL 97.2 mg/1 CIV N 20181231 69336-124_d4fd9e95-45e9-4db2-9393-a8605ba962c4 69336-124 HUMAN PRESCRIPTION DRUG FENOPROFEN CALCIUM FENOPROFEN CALCIUM CAPSULE ORAL 20160706 NDA NDA017604 Sterling Knight Pharmaceuticals FENOPROFEN CALCIUM 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 69336-200_c4a49b96-66bb-4d76-93d7-d39afc7724c0 69336-200 HUMAN PRESCRIPTION DRUG Synvexia Lidocaine Hydrochloride and Menthol PATCH TOPICAL 20141114 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals,LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 69336-201_d2a5f2a5-6c0c-46ea-a06e-a71950ce359f 69336-201 HUMAN PRESCRIPTION DRUG Synvexia TC Lidocaine Hydrochloride and Menthol CREAM TOPICAL 20141201 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 69336-202_74e88119-d95e-4e1c-aa98-ebf8a8b91a92 69336-202 HUMAN PRESCRIPTION DRUG Flexipak diclofenac sodium, capsaicin KIT 20180119 ANDA ANDA075185 Sterling-Knight Pharmaceuticals, LLC N 20191231 69336-203_3eef7480-dd46-4e02-9a8d-164f834620ce 69336-203 HUMAN PRESCRIPTION DRUG Diclopak diclofenac sodium, capsaicin KIT 20180101 ANDA ANDA204132 Sterling-Knight Pharmaceuticals, LLC N 20191231 69336-300_27cabc63-3401-4cd8-ae52-e1d8cea28af4 69336-300 HUMAN PRESCRIPTION DRUG Durachol Durachol CAPSULE ORAL 20141116 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals,LLC CHOLECALCIFEROL; FOLIC ACID 3775; 1 [iU]/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC] E 20171231 69336-310_d308b188-b0b5-4746-a607-d704eed19326 69336-310 HUMAN PRESCRIPTION DRUG Cifrazol Cifrazol CAPSULE ORAL 20170110 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals,LLC CHOLECALCIFEROL; FOLIC ACID 3775; 1 [iU]/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 69336-330_0206c671-3014-44b9-b3e8-4357f393452b 69336-330 HUMAN PRESCRIPTION DRUG Revesta Revesta CAPSULE ORAL 20161013 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals,LLC CHOLECALCIFEROL; FOLIC ACID 5750; 1 [iU]/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 69336-350_9b74d855-bc07-4fa4-b48d-aafdff54343d 69336-350 HUMAN PRESCRIPTION DRUG Methazel Methazel CAPSULE ORAL 20151012 UNAPPROVED DRUG OTHER Sterling-Knight Pharmaceuticals, LLC FOLIC ACID; PYRIDOXAL 5-PHOSPHATE; METHYLCOBALAMIN; COENZYME Q10, (2Z)-; ALPHA LIPOIC ACID; ACETYLCYSTEINE 1; 50; 2.5; 25; 50; 50 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA] E 20171231 69336-353_1e7cac63-bfab-4dde-adfb-f7a19c09c4a2 69336-353 HUMAN PRESCRIPTION DRUG Methaver Methaver CAPSULE ORAL 20151124 UNAPPROVED DRUG OTHER Sterling-knight Pharmaceuticals,LLC FOLIC ACID; RIBOFLAVIN; METHYLCOBALAMIN; THIAMINE HYDROCHLORIDE; PYRIDOXINE HYDROCHLORIDE 1; 29; 2; 27; 50 mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 69336-358_8369117c-4300-4deb-a40b-b80d10526751 69336-358 HUMAN PRESCRIPTION DRUG Lexazin Lexazin CAPSULE ORAL 20180102 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals LLC ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; NADH; COENZYME Q10, (2Z)- 125; 500; 25; 12.5; 1; 5; 5; 50 mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20191231 69336-500_fc406432-3581-4a20-ae71-0386b8ed47dd 69336-500 HUMAN PRESCRIPTION DRUG Adazin Capsaicin/Benzocaine/Lidocaine/Methyl Salicylate CREAM TOPICAL 20141203 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals, LLC CAPSAICIN; BENZOCAINE; LIDOCAINE; METHYL SALICYLATE .035; 2; 2; 1 g/100g; g/100g; g/100g; g/100g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 69336-600_db867f2b-6ece-4ca4-8b10-bd8318ef4724 69336-600 HUMAN PRESCRIPTION DRUG Provenza Menthol and Lidocaine PATCH TOPICAL 20141219 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals,LLC MENTHOL; LIDOCAINE 1; 4 g/g; g/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 69336-700_5bc2c49c-f0f4-428a-8db7-1d1342492000 69336-700 HUMAN PRESCRIPTION DRUG LIDOVEX Lidocaine Hydrochloride CREAM TOPICAL 20141214 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals, LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS 37.5 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 69336-710_478606c9-48c3-46e1-9293-6ed694dac429 69336-710 HUMAN PRESCRIPTION DRUG Lidozol Lidocaine hydrochloride CREAM TOPICAL 20150430 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals,LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS 37.5 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 69336-720_b86c7e09-3391-4ad5-86ac-17813d03421a 69336-720 HUMAN PRESCRIPTION DRUG Lidovin Lidocaine hydrochloride CREAM TOPICAL 20150430 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals,LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS 39.5 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 69336-801_30599f0f-9480-4823-af8a-cfd41152e668 69336-801 HUMAN PRESCRIPTION DRUG UREVAZ Urea Cream 44% CREAM TOPICAL 20150521 UNAPPROVED DRUG OTHER Sterling Knight Pharmaceuticals, LLC UREA 440 mg/g E 20171231 69336-825_ee4ad118-aa3d-4a6c-ac40-8776d841fd71 69336-825 HUMAN PRESCRIPTION DRUG LIDOPRIL Lidocaine 2.5% and Prilocaine 2.5% CREAM TOPICAL 20160707 NDA NDA019941 Sterling-knight Pharmaceuticals,LLC LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 69336-826_30b6be75-d374-4406-b01c-ea6004f5e7b1 69336-826 HUMAN PRESCRIPTION DRUG LIDOPRIL XR Lidocaine 2.5% and Prilocaine 2.5% CREAM TOPICAL 20160816 NDA NDA019941 Sterling-knight Pharmaceuticals,LLC LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 69336-827_8bc0f638-1e2d-4d3e-869e-eb36ce34b581 69336-827 HUMAN PRESCRIPTION DRUG DICLOZOR DICLOFENAC SODIUM GEL TOPICAL 20161004 ANDA ANDA208077 Sterling-Knight Pharmaceuticals, LLC DICLOFENAC SODIUM 1 g/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69336-828_d18fe138-b9e5-44ab-b9da-4cf2b148f780 69336-828 HUMAN PRESCRIPTION DRUG PRILOLID Lidocaine 2.5% and Prilocaine 2.5% CREAM TOPICAL 20161005 NDA NDA019941 Sterling-knight Pharmaceuticals,LLC LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 69336-829_52bbdbbb-3298-4a9a-871c-9061bc55c759 69336-829 HUMAN PRESCRIPTION DRUG Lidopac Lidocaine OINTMENT TOPICAL 20160815 ANDA ANDA206297 Sterling-Knight Pharmaceuticals, LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 69338-001_7ac8f3c3-5c15-44fe-9b13-6f5af2c174f0 69338-001 HUMAN OTC DRUG FreshDent Kids Strawberry Anticavity Tooth Sodium Fluoride PASTE, DENTIFRICE DENTAL 20141106 OTC MONOGRAPH FINAL part355 FreshDent LLC SODIUM FLUORIDE .65 mg/g E 20171231 69338-002_a5acc4f6-b53f-4a17-a889-ef681cfdf27b 69338-002 HUMAN OTC DRUG FreshDent Cavity Protection Anticavity SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20141106 OTC MONOGRAPH FINAL part355 FreshDent LLC SODIUM MONOFLUOROPHOSPHATE .85 mg/g E 20171231 69339-123_e04ae685-2d0f-44e6-9252-3c27d7dec863 69339-123 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Delayed-Release Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20150218 ANDA ANDA200540 Dash Pharmaceuticals LLC DICLOFENAC SODIUM; MISOPROSTOL 50; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 69339-124_e04ae685-2d0f-44e6-9252-3c27d7dec863 69339-124 HUMAN PRESCRIPTION DRUG Diclofenac Sodium and Misoprostol Delayed-Release Diclofenac Sodium and Misoprostol TABLET, DELAYED RELEASE ORAL 20150123 ANDA ANDA200540 Dash Pharmaceuticals LLC DICLOFENAC SODIUM; MISOPROSTOL 75; .2 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 69339-135_63b9e9fb-caef-4231-8c0e-0e52f0aeaf28 69339-135 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20170221 ANDA ANDA207783 Dash Pharmaceuticals LLC CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 69343-121_0b6ae4b6-dd4c-4ca7-9ad5-552cb250f10d 69343-121 HUMAN OTC DRUG Elyptol Antimicrobial Hand Gel Ethanol GEL TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part333A Elyptol Inc. ALCOHOL 7 mL/10mL N 20181231 69343-221_5a330797-433e-4722-9218-b752a8b54ce6 69343-221 HUMAN OTC DRUG Elyptol Antimicrobial Rub Ethanol SOLUTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part333A Elyptol Inc. ALCOHOL 7 mL/10mL N 20181231 69343-322_6199ad50-4091-4fee-e053-2991aa0aaf5e 69343-322 HUMAN OTC DRUG Elyptol Hand Sanitizer Wipe Ethanol CLOTH TOPICAL 20161215 OTC MONOGRAPH NOT FINAL part333A Elyptol Inc. ALCOHOL .7 1/1 N 20181231 69343-421_4c8708f9-6ada-125b-e054-00144ff8d46c 69343-421 HUMAN OTC DRUG Elyptol Light Scent- Antimicrobial Hand Gel Ethanol GEL TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part333A ELYPTOL INC. ALCOHOL 7 mL/10mL N 20181231 69343-521_619ba3c7-5218-8632-e053-2a91aa0a74e9 69343-521 HUMAN OTC DRUG Elyptol Light Scent Antimicrobial Ethanol SPRAY TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part333A ELYPTOL INC. ALCOHOL 7 mL/10mL N 20181231 69344-111_5cd84859-27cd-40d1-992c-781f14d9c924 69344-111 HUMAN PRESCRIPTION DRUG Arymo ER morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170201 NDA NDA208603 Egalet US Inc. MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 69344-113_cecad914-45ab-4489-a1e9-761d3d45042f 69344-113 HUMAN PRESCRIPTION DRUG OXAYDO OXYCODONE HYDROCHLORIDE TABLET ORAL 20150901 NDA NDA202080 Egalet US Inc. OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 69344-144_9d0c159d-af56-45a5-843c-ccc26f9828bc 69344-144 HUMAN PRESCRIPTION DRUG Sprix ketorolac tromethamine SPRAY, METERED NASAL 20110426 NDA NDA022382 Egalet US Inc. KETOROLAC TROMETHAMINE 15.75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20191231 69344-211_5cd84859-27cd-40d1-992c-781f14d9c924 69344-211 HUMAN PRESCRIPTION DRUG Arymo ER morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170201 NDA NDA208603 Egalet US Inc. MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 69344-213_cecad914-45ab-4489-a1e9-761d3d45042f 69344-213 HUMAN PRESCRIPTION DRUG OXAYDO OXYCODONE HYDROCHLORIDE TABLET ORAL 20150901 NDA NDA202080 Egalet US Inc. OXYCODONE HYDROCHLORIDE 7.5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 69344-311_5cd84859-27cd-40d1-992c-781f14d9c924 69344-311 HUMAN PRESCRIPTION DRUG Arymo ER morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170201 NDA NDA208603 Egalet US Inc. MORPHINE SULFATE 60 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 69345-200_4473ee11-0221-43cb-8483-b6d578c22a1a 69345-200 HUMAN OTC DRUG Altitude Medical Hand Sanitizer Ethyl alcohol GEL TOPICAL 20161207 OTC MONOGRAPH NOT FINAL part333E Altitude Medical ALCOHOL 69.8 mL/100mL N 20181231 69345-520_f103ab16-e0b1-4342-beef-4458812dc1f6 69345-520 HUMAN OTC DRUG AltitudeMedical HAND ANTIBACTERIAL ALCOHOL SOAP TOPICAL 20150122 OTC MONOGRAPH NOT FINAL part333E Altitude Medical Inc ALCOHOL .62 mL/mL E 20171231 69346-0001_3c5af14a-3aa0-0a78-e054-00144ff88e88 69346-0001 HUMAN OTC DRUG WELLAGE FAMILY MASK SMALL Sodium Hyaluronate PATCH TOPICAL 20160901 UNAPPROVED DRUG OTHER HUGEL PHARMA CO.,LTD HYALURONATE SODIUM .056 g/100mL E 20171231 69346-0003_3bf6a061-0a92-590e-e054-00144ff8d46c 69346-0003 HUMAN OTC DRUG WELLAGE BLACK AQUA ROLL MASK PACK GLYCERIN PATCH TOPICAL 20160908 UNAPPROVED DRUG OTHER HUGEL PHARMA CO.,LTD GLYCERIN 10 g/100mL E 20171231 69346-0004_3bf6a061-0aa0-590e-e054-00144ff8d46c 69346-0004 HUMAN OTC DRUG WELLAGE WHITE AQUA ROLL MASK PACK GLYCERIN PATCH TOPICAL 20160908 UNAPPROVED DRUG OTHER HUGEL PHARMA CO.,LTD GLYCERIN 10 g/100mL E 20171231 69346-0005_3bf54d7e-473c-24d8-e054-00144ff88e88 69346-0005 HUMAN OTC DRUG WELLAGE Deep Layer Silky Facial Oil Simmondsia Chinensis (Jojoba) Seed Oil, Argania Spinosa Kernel Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Squalane OIL TOPICAL 20160501 UNAPPROVED DRUG OTHER HUGEL PHARMA CO.,LTD MEADOWFOAM SEED OIL; SQUALANE; ARGAN OIL; SIMMONDSIA CHINENSIS SEED 6; 6; 15; 35.1995 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 69346-0006_3bf849fc-2c26-0e17-e054-00144ff88e88 69346-0006 HUMAN OTC DRUG WELLAGE DEEP LAYER FRESH MOISTURE NIACINAMIDE, ADENOSINE CREAM TOPICAL 20160908 UNAPPROVED DRUG OTHER HUGEL PHARMA CO.,LTD NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL E 20171231 69346-0007_3bf54d7e-4754-24d8-e054-00144ff88e88 69346-0007 HUMAN OTC DRUG WELLAGE FRESH WATER ESSENCE MIST NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20160908 UNAPPROVED DRUG OTHER HUGEL PHARMA CO.,LTD NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL E 20171231 69346-0008_3c5b1523-fa14-45af-e054-00144ff8d46c 69346-0008 HUMAN OTC DRUG WELLAGE FAMILY MASK LARGE Sodium Hyaluronate PATCH TOPICAL 20160901 UNAPPROVED DRUG OTHER HUGEL PHARMA CO.,LTD HYALURONATE SODIUM .056 g/100mL E 20171231 69346-0101_f7b74662-fa4e-487c-975b-0bd8efb5efd1 69346-0101 HUMAN OTC DRUG WELLAGE Vital Nio Nutritional Rich GLYCERIN CREAM TOPICAL 20150731 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD GLYCERIN 6.2 g/100mL E 20171231 69346-1001_babab33c-5f4c-466d-97ba-cee6c5f2d32d 69346-1001 HUMAN OTC DRUG WELLAGE POST PROCEDURE GLYCERIN CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD. GLYCERIN 5 g/100mL E 20171231 69346-1101_f6324a11-52d4-4f77-b133-f97f205caab1 69346-1101 HUMAN OTC DRUG WELLAGE Vital Nio Enrich GLYCERIN EMULSION TOPICAL 20150731 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD GLYCERIN 2.04 g/100mL E 20171231 69346-1201_3407ddb0-bd96-48ca-96da-c6ea9225906f 69346-1201 HUMAN OTC DRUG WELLAGE Vital Nio Waterlock Toner GLYCERIN LIQUID TOPICAL 20150731 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD GLYCERIN 2 g/100mL E 20171231 69346-1301_19b0e122-ace4-44c2-bd70-b2ba7c3ee9f4 69346-1301 HUMAN OTC DRUG WELLAGE Concentrated Illumination Expert GLYCERIN LIQUID TOPICAL 20150903 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD GLYCERIN .2 g/100mL E 20171231 69346-1401_a6f7f645-43cc-47c2-8b29-7db58ec13313 69346-1401 HUMAN OTC DRUG WELLAGE Vita Blue Injec-tion Mask GLYCERIN LIQUID TOPICAL 20151028 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD GLYCERIN .2 g/100mL E 20171231 69346-1501_7c1d04d3-b8c9-44e6-89a6-8d157f0d9826 69346-1501 HUMAN OTC DRUG WELLAGE Vita Red Injec-tion Mask GLYCERIN LIQUID TOPICAL 20151028 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD GLYCERIN .2 g/100mL E 20171231 69346-2001_375cdc70-f1fd-41ca-a7e1-946e34d2c310 69346-2001 HUMAN OTC DRUG WELLAGE DEEP LAYER MOISTURIZER SLEEPING MASK GLYCERIN CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD. GLYCERIN .2 g/100mL E 20171231 69346-3001_11705090-d00d-41d1-ba71-369ab35fe21b 69346-3001 HUMAN OTC DRUG B BIND REJUVENATING NEOENDORPHIN MASK PACK GLYCERIN LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD. GLYCERIN 10 g/100g E 20171231 69346-4001_4215ee73-c7f0-4928-95e0-d94588d836ee 69346-4001 HUMAN OTC DRUG WELLAGE Post Procedure Point Concealer TITANIUM DIOXIDE CREAM TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 HUGEL PHARMA CO.,LTD TITANIUM DIOXIDE 25 g/100g E 20171231 69346-5001_c8a48abf-a453-4f70-a5fd-808c38cf20a8 69346-5001 HUMAN OTC DRUG WELLAGE WRINKLE REDUCED VIALS GLYCERIN CONCENTRATE TOPICAL 20150122 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD GLYCERIN 7 g/100mL E 20171231 69346-6001_202e43e6-9d09-4932-a609-bb4e5d6702fe 69346-6001 HUMAN OTC DRUG WELLAGE 4D Gold Essence GLYCERIN EXTRACT TOPICAL 20150122 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD GLYCERIN 13.226 g/100mL E 20171231 69346-7001_3fcab062-843a-4c21-9f99-2f5b87dfa847 69346-7001 HUMAN OTC DRUG WELLAGE Intensive Repair Serum GLYCERIN LIQUID TOPICAL 20150122 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD GLYCERIN 10 g/100mL E 20171231 69346-8001_bd509b52-f714-46a0-b56f-1fb265fccfaf 69346-8001 HUMAN OTC DRUG WELLAGE Double Lift Mask Pack Moisturizing Hydrogel Mask GLYCERIN LIQUID TOPICAL 20150530 OTC MONOGRAPH FINAL part347 HUGEL PHARMA CO.,LTD GLYCERIN 10 g/100g E 20171231 69346-9001_09515e46-a8c4-4fc9-8963-802c6f8cd250 69346-9001 HUMAN OTC DRUG WELLAGE Hyaluronic Acid Micro Needle HYALURONIC ACID PATCH TOPICAL 20141104 UNAPPROVED DRUG OTHER HUGEL PHARMA CO.,LTD HYALURONIC ACID 99 g/100g E 20171231 69348-100_b27e1b3d-0b34-4f32-a775-bb4deb3e22ec 69348-100 HUMAN OTC DRUG BSafe Instant Foaming Hand Sanitizer Benzalkonium Chloride AEROSOL, FOAM TOPICAL 20141204 OTC MONOGRAPH NOT FINAL part333E Med-Dev Corporation BENZALKONIUM CHLORIDE 1 mg/1000mL E 20171231 69349-100_0888d96b-76a8-0d18-e054-00144ff8d46c 69349-100 HUMAN OTC DRUG FOUNDATION BALANCED SATIN FINISH SPF15 TITANIUM DIOXIDE LIQUID TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 Modern Beauty TITANIUM DIOXIDE; OCTINOXATE 10; 2.5 mg/mL; mg/mL E 20171231 69349-101_0546f99d-e8b1-4cd5-8060-66ff305ce115 69349-101 HUMAN OTC DRUG BB Cream Skin perfector beauty balm SPF 18 TITANIUM DIOXIDE AND ETHYLHEXYL METHOXYCINNAMATE CREAM TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part352 Modern Beauty Limited TITANIUM DIOXIDE; OCTINOXATE 9; 2 mg/mL; mg/mL N 20181231 69349-102_f14dd99d-a99a-481e-b496-aa22e2735557 69349-102 HUMAN OTC DRUG Mineralized Loose Powder SPF 15 TITANIUM DIOXIDE, ETHYLHEXYL METHOXYCINNAMATE POWDER TOPICAL 20151205 OTC MONOGRAPH NOT FINAL part352 Modern Beauty Limited TITANIUM DIOXIDE; OCTINOXATE 7.12; 2 mg/g; mg/g E 20171231 69349-103_dc91b433-59ad-4069-901b-9db24b26dbbe 69349-103 HUMAN OTC DRUG FOUNDATION BALANCED SATIN FINISH SPF 15 TITANIUM DIOXIDE, ETHYLHEXYL METHOXYCINNAMATE LOTION TOPICAL 20141101 OTC MONOGRAPH NOT FINAL part352 Modern Beauty Limited TITANIUM DIOXIDE; OCTINOXATE 10; 2.5 mg/mL; mg/mL N 20181231 69349-104_0ec694e9-4c06-4f52-9238-aa3794f3c877 69349-104 HUMAN OTC DRUG Studio Blend Cover Foundation SPF 15 TITANIUM DIOXIDE CREAM TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part352 Modern Beauty Limited TITANIUM DIOXIDE 12 mg/mL N 20181231 69351-010_8dcdacbb-11f3-4f73-a24a-45eac4b3e2d2 69351-010 HUMAN OTC DRUG SOOSUL ESSENCE ALLANTOIN CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Sang Hwang Mi-in Co., Ltd. ALLANTOIN .28 mg/40mL E 20171231 69351-020_598018af-49e1-41c4-9a1c-4deeb9e5faaa 69351-020 HUMAN OTC DRUG SOOSUL GINSENG DIMETHICONE CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Sang Hwang Mi-in Co., Ltd. DIMETHICONE 1.2 g/60g E 20171231 69351-030_8225def9-211e-40df-834a-80cf32c77b21 69351-030 HUMAN OTC DRUG SOOSUL WHITENING SLEEPING PACK DIMETHICONE CREAM TOPICAL 20141001 OTC MONOGRAPH FINAL part347 Sang Hwang Mi-in Co., Ltd. DIMETHICONE 1.44 g/120g E 20171231 69352-010_c0499f13-5f18-4536-bc5a-91da96c27ff9 69352-010 HUMAN OTC DRUG AMARTE NATURAL FINISH BB Titanium Dioxide, Octinoxate CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 AMARTEINTERNATIONAL CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 2.8; 2 mg/40mL; mg/40mL N 20181231 69352-020_e4aa261a-6314-4e03-8803-b3a1879d4969 69352-020 HUMAN OTC DRUG AMARTE ULTRA VEIL ULTRA LIGHT SUNSCREEN FLUID Octinoxate, Titanium Dioxide, Octisalate, Zinc Oxide CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 AMARTEINTERNATIONAL CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE 4.9; 3.78; 3.5; 2.1 mg/70mL; mg/70mL; mg/70mL; mg/70mL N 20181231 69353-001_89eae280-f8ae-45a8-9e09-aa90c970c6c7 69353-001 HUMAN OTC DRUG Singiso Red Ginseng TABLET ORAL 20141115 UNAPPROVED DRUG OTHER FDA TRADING CO.,LTD. ASIAN GINSENG .125 g/1 N 20181231 69358-0001_4c50d980-5301-4830-814e-311f69550dd6 69358-0001 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0002_0273254a-bbbc-4a71-af37-4b04fc452571 69358-0002 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0003_a162f7fd-3113-4132-881d-15d020ebfe59 69358-0003 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0004_c1de95a1-c4b6-46ee-98c5-62d519198075 69358-0004 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0005_fd6c93aa-fa04-4088-8c06-20f63ce24002 69358-0005 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0006_49cf4cd6-7df1-4b74-9da4-dc62ea382096 69358-0006 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0007_f23c99a9-4ec4-4c0d-a9d9-ddcb8bf49626 69358-0007 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20141112 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0008_208ac248-e133-6aa5-e054-00144ff8d46c 69358-0008 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20150925 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0009_20933ed9-196f-6507-e054-00144ff8d46c 69358-0009 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20150925 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0010_20945bbe-7412-2bad-e054-00144ff8d46c 69358-0010 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20150925 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0011_20945b71-bb4f-2bab-e054-00144ff8d46c 69358-0011 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20150925 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0012_20945bbe-7418-2bad-e054-00144ff8d46c 69358-0012 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20150925 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0013_20945bbe-7429-2bad-e054-00144ff8d46c 69358-0013 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20150925 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0014_20945bbe-7439-2bad-e054-00144ff8d46c 69358-0014 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20150925 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0015_2ec68597-4180-4b57-e054-00144ff8d46c 69358-0015 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20150925 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0016_2ec750c8-4ea1-23ec-e054-00144ff88e88 69358-0016 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20160324 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0017_2ec7f572-b377-7373-e054-00144ff88e88 69358-0017 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20160324 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0018_2ed6cf01-01a9-04af-e054-00144ff88e88 69358-0018 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20160324 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0019_2ed6cf01-01af-04af-e054-00144ff88e88 69358-0019 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20160324 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0020_2ed6cf01-01b5-04af-e054-00144ff88e88 69358-0020 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20160324 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69358-0021_2ed6cf01-01ba-04af-e054-00144ff88e88 69358-0021 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20160324 OTC MONOGRAPH NOT FINAL part333E UniGroup Wholesale Inc. ALCOHOL 62 mL/100mL N 20181231 69359-000_e7c5fce0-d31f-4114-b8ea-610bef25431a 69359-000 HUMAN OTC DRUG Lipidol Avobenzone, Homosalate, Octisalate, Octocrylene OIL TOPICAL 20141107 OTC MONOGRAPH FINAL part352 UNION-SWISS (PTY) LTD AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 6; 5; 6.5 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 69362-250_4807ddbe-16ed-6111-e054-00144ff8d46c 69362-250 HUMAN OTC DRUG GREEN BAMBOO MENTHOL CREAM TOPICAL 20141110 OTC MONOGRAPH NOT FINAL part348 Balance Center, Inc. MENTHOL 5 g/100g N 20181231 69365-001_5673c50b-3c50-41dd-e054-00144ff88e88 69365-001 HUMAN OTC DRUG Facol Cold and Flu Day acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide CAPSULE, LIQUID FILLED ORAL 20150801 OTC MONOGRAPH NOT FINAL part343 JW Holdings ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 200; 35; 8; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 69365-003_5674d57c-893e-44cc-e054-00144ff8d46c 69365-003 HUMAN OTC DRUG Facol Cold and Flu Night acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl CAPSULE, LIQUID FILLED ORAL 20150801 OTC MONOGRAPH NOT FINAL part343 JW HOLDINGS ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE 200; 35; 5; 8; 18.75 mg/1; mg/1; mg/1; mg/1; mg/1 N 20181231 69365-004_5674d57c-8950-44cc-e054-00144ff8d46c 69365-004 HUMAN OTC DRUG Facol Cold and Flu Day and Night acetaminphen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl, lac color, gardenia blue CAPSULE, LIQUID FILLED ORAL 20150801 OTC MONOGRAPH NOT FINAL part343 JW HOLDINGS DIPHENHYDRAMINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN 18.75; 8; 5; 35; 200 mg/1; mg/1; mg/1; mg/1; mg/1 N 20181231 69366-201_d6da4ef9-dbb9-4660-8607-7cb8a06a41a3 69366-201 HUMAN OTC DRUG Honest Sunscreen Broad Spectrum SPF 30 Zinc Oxide LOTION TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 The Honest Company, Inc. ZINC OXIDE 9.3 g/100mL N 20181231 69366-202_3398fe31-265b-0f78-e054-00144ff88e88 69366-202 HUMAN OTC DRUG Honest Sunscreen SPF 30 Broad Spectrum SPF 30 Zinc Oxide SPRAY, SUSPENSION TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 The Honest Company, Inc. ZINC OXIDE 12 g/100mL N 20181231 69366-203_339b1545-a1b0-51ee-e054-00144ff88e88 69366-203 HUMAN OTC DRUG Purely Simple Sunscreen Stick Broad Spectrum SPF 30 Zinc Oxide STICK TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 The Honest Company, Inc. ZINC OXIDE 20 g/100g N 20181231 69366-204_ee48d467-dc8d-435f-983d-270ee18c1ea5 69366-204 HUMAN OTC DRUG Everything Tinted Moisturizer Broad Spectrum SPF 20 Zinc Oxide LOTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 The Honest Company, Inc. ZINC OXIDE 13.6 g/100mL E 20171231 69366-205_2cc41da6-71b6-4c12-8951-965c2ef7810b 69366-205 HUMAN OTC DRUG Everything Tinted Moisturizer Oil Free Broad Spectrum SPF 20 Zinc Oxide LOTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 The Honest Company, Inc. ZINC OXIDE 13.6 g/100mL E 20171231 69366-206_eadc73c9-ca43-4f8f-83d0-03ae5692fb64 69366-206 HUMAN OTC DRUG Beyond Protected Daily Beauty Fluid Broad Spectrum SPF 30 Zinc Oxide LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 The Honest Company, Inc. ZINC OXIDE 19.7 g/100mL E 20171231 69366-207_3080cec4-929d-4957-bc68-e16b2698f916 69366-207 HUMAN OTC DRUG Beyond Protected Daily Beauty Fluid Sheer Tint Broad Spectrum SPF 30 Zinc Oxide LOTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 The Honest Company, Inc. ZINC OXIDE 19.7 g/100mL E 20171231 69366-208_57464cd8-3c6c-4f8b-96ab-503872fa7078 69366-208 HUMAN OTC DRUG Beyond Protected Daily Beauty Fluid Oil Free Broad Spectrum SPF 30 Zinc Oxide LOTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 The Honest Company, Inc. ZINC OXIDE 19.7 g/100mL E 20171231 69366-209_c5ec9404-4868-4123-ac21-aab53c7ffb1f 69366-209 HUMAN OTC DRUG Honest Mineral Sunscreen Broad Spectrum SPF 50 Zinc Oxide LOTION TOPICAL 20160412 OTC MONOGRAPH NOT FINAL part352 The Honest Company, Inc. ZINC OXIDE 19 g/100mL N 20191231 69366-301_33ac19ad-81d0-3ee3-e054-00144ff88e88 69366-301 HUMAN OTC DRUG Hand Sanitizer Orange with aloe 62% Hand Sanitizer Spray SPRAY TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A The Honest Company, Inc. ALCOHOL 62 mL/100mL N 20181231 69366-302_33aca9f0-61b4-3f37-e054-00144ff8d46c 69366-302 HUMAN OTC DRUG Hand Sanitizer Lavender with aloe 62% Hand Sanitizer Spray SPRAY TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A The Honest Company, Inc. ALCOHOL 62 mL/100mL N 20181231 69366-303_33abadd8-b549-3431-e054-00144ff88e88 69366-303 HUMAN OTC DRUG Hand Sanitizer Lemongrass with aloe 62% ethyl alcohol SPRAY TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A The Honest Company, Inc. ALCOHOL 62 mL/100mL N 20181231 69366-304_339d0c3a-1119-187a-e054-00144ff88e88 69366-304 HUMAN OTC DRUG hand sanitizer orange with aloe 62% ethyl alcohol GEL TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A The Honest Company, Inc. ALCOHOL 62 mL/100mL N 20181231 69366-305_339c2ea4-c15b-408e-e054-00144ff8d46c 69366-305 HUMAN OTC DRUG hand sanitizer lavender with aloe 62% Ethyl Alcohol GEL TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A The Honest Company, Inc. ALCOHOL 62 mL/100mL N 20181231 69366-306_33ab334e-5bca-66b7-e054-00144ff8d46c 69366-306 HUMAN OTC DRUG Hand Sanitizer Lemongrass with aloe 62% Ethyl Alcohol GEL TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A The Honest Company, Inc. ALCOHOL 62 mL/100mL N 20181231 69366-307_33bf9377-c1f7-61c3-e054-00144ff8d46c 69366-307 HUMAN OTC DRUG Hand Sanitizer Orange with aloe 62% Ethyl Alcohol GEL TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A The Honest Company, Inc. ALCOHOL 62 mL/100mL N 20181231 69366-308_33c09e38-6dec-3af6-e054-00144ff88e88 69366-308 HUMAN OTC DRUG Hand Sanitizer Lavender with aloe 62% Ethyl Alcohol GEL TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A The Honest Company, Inc. ALCOHOL 62 mL/100mL N 20181231 69366-309_33ac7738-192d-3470-e054-00144ff8d46c 69366-309 HUMAN OTC DRUG Hand sanitizer lemongrass with aloe 62% Ethyl Alcohol GEL TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A The Honest Company, Inc. ALCOHOL 62 mL/100mL N 20181231 69366-310_53fd195e-641f-064e-e054-00144ff88e88 69366-310 HUMAN OTC DRUG Hand Sanitizer Coastal Surf 62% Ethyl Alcohol SPRAY TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part333A The Honest Company ALCOHOL 62 mL/100mL N 20181231 69366-311_540d671e-5268-5b58-e054-00144ff88e88 69366-311 HUMAN OTC DRUG Hand Sanitizer Free and Clear 62% Ethyl Alcohol SPRAY TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part333A The Honest Company ALCOHOL 62 mL/100mL N 20181231 69366-312_540f8d6c-4473-2864-e054-00144ff88e88 69366-312 HUMAN OTC DRUG Hand Sanitizer Graepfruit Grove 62% Ethyl Alcohol SPRAY TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part333A The Honest Company ALCOHOL 62 mL/100mL N 20181231 69366-313_5410fbfc-fb91-3bce-e054-00144ff8d46c 69366-313 HUMAN OTC DRUG Hand Sanitizer Lavender Field 62% Ehtyl Alcohol SPRAY TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part333A The Honest Company ALCOHOL 62 mL/100mL N 20181231 69366-314_54116886-ea66-5320-e054-00144ff8d46c 69366-314 HUMAN OTC DRUG Hand Sanitizer Free and Clear 62% Ethyl Alcohol GEL TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part333A The Honest Company ALCOHOL 62 mL/100mL N 20181231 69366-315_5411f8d6-9fe0-6d5e-e054-00144ff8d46c 69366-315 HUMAN OTC DRUG Hand Sanitizer Grapefruit Grove 62% Ethyl Alcohol GEL TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part333A The Honest Company ALCOHOL 62 mL/100mL N 20181231 69366-401_056392fb-32a6-45ef-83dd-1b0959c27ac2 69366-401 HUMAN OTC DRUG Younger Clearer Night Serum with Honestly Pure Retinol 0.5% Salicylic Acid Acne Treatment Salicylic Acid CREAM TOPICAL 20170801 OTC MONOGRAPH FINAL part333D The Honest Company, Inc. SALICYLIC ACID .5 g/100g N 20181231 69366-403_7e0ebda2-70f8-48d2-b689-44e338f383ef 69366-403 HUMAN OTC DRUG Younger Clearer Resurfacing Cleanser 0.5% Salicylic Acid Acne Treatment Salicylic Acid GEL TOPICAL 20170801 OTC MONOGRAPH FINAL part333D The Honest Company, Inc. SALICYLIC ACID .5 g/100g N 20181231 69366-405_5a29f454-56e9-4edf-ab8c-ab39c8030b1e 69366-405 HUMAN OTC DRUG Younger Clearer Spot-On Remedy 2% Salicylic Acid Acne Treatment Salicylic Acid GEL TOPICAL 20170801 OTC MONOGRAPH FINAL part333D The Honest Company, Inc. SALICYLIC ACID 2 g/100g N 20181231 69366-406_8e288a16-b20e-41e9-a335-883f8adcfbdb 69366-406 HUMAN OTC DRUG Advanced Acne Regimen with Honestly Pure Retinol 0.5% Salicylic Acid Acne Treatment Salicylic Acid KIT 20170801 OTC MONOGRAPH FINAL part333D The Honest Company, Inc. N 20181231 69367-109_20ede872-503c-398e-e054-00144ff8d46c 69367-109 HUMAN PRESCRIPTION DRUG Brimonidine Tartrate Ophthalmic Solution, 0.2% Brimonidine Tartrate Ophthalmic Solution, 0.2% SOLUTION/ DROPS OPHTHALMIC 20150918 ANDA ANDA091691 Westminster Pharmaceuticals, LLC BRIMONIDINE TARTRATE 2 mg/mL Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] N 20181231 69367-119_2aba2a7a-306f-3711-e054-00144ff88e88 69367-119 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20160201 ANDA ANDA204774 Westminster Pharmaceuticals, LLC IRBESARTAN 75 mg/75mg Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 69367-120_2aba2a7a-306f-3711-e054-00144ff88e88 69367-120 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20160201 ANDA ANDA204774 Westminster Pharmaceuticals, LLC IRBESARTAN 150 mg/150mg Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 69367-121_2aba2a7a-306f-3711-e054-00144ff88e88 69367-121 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20160201 ANDA ANDA204774 Westminster Pharmaceuticals, LLC IRBESARTAN 300 mg/300mg Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 69367-122_2ab8db36-1300-5278-e054-00144ff8d46c 69367-122 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20160201 ANDA ANDA203018 Westminster Pharmaceuticals, LLC HYDROCHLOROTHIAZIDE 25 mg/25mg Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69367-123_2ab8db36-1300-5278-e054-00144ff8d46c 69367-123 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20160201 ANDA ANDA203018 Westminster Pharmaceuticals, LLC HYDROCHLOROTHIAZIDE 50 mg/50mg Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69367-131_304f1d5a-218e-51ae-e054-00144ff88e88 69367-131 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160401 ANDA ANDA204989 Westminster Pharmaceuticals, LLC GABAPENTIN 100 mg/100mg Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69367-132_304f1d5a-218e-51ae-e054-00144ff88e88 69367-132 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160401 ANDA ANDA204989 Westminster Pharmaceuticals, LLC GABAPENTIN 300 mg/300mg Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69367-133_304f1d5a-218e-51ae-e054-00144ff88e88 69367-133 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20160401 ANDA ANDA204989 Westminster Pharmaceuticals, LLC GABAPENTIN 400 mg/400mg Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69367-134_a2469403-3b26-46a7-b77b-79c3dd723348 69367-134 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20160411 ANDA ANDA205101 Westminster Pharmaceuticals, LLC GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69367-135_a2469403-3b26-46a7-b77b-79c3dd723348 69367-135 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20160411 ANDA ANDA205101 Westminster Pharmaceuticals, LLC GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69367-154_38a2d4c1-e32a-2dbb-e054-00144ff8d46c 69367-154 HUMAN PRESCRIPTION DRUG Probenecid Probenecid TABLET ORAL 20160728 ANDA ANDA084442 Westminster Pharmaceuticals, LLC PROBENECID 500 mg/1 N 20181231 69367-155_e6467f80-687f-4cc2-8cb0-e7ea91288940 69367-155 HUMAN PRESCRIPTION DRUG Levothyroxine and Liothyronine Thyroid LEVOTHYROXINE and LIOTHYRONINE TABLET ORAL 20170919 UNAPPROVED DRUG OTHER Westminster Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 19; 4.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 69367-156_e6467f80-687f-4cc2-8cb0-e7ea91288940 69367-156 HUMAN PRESCRIPTION DRUG Levothyroxine and Liothyronine Thyroid LEVOTHYROXINE and LIOTHYRONINE TABLET ORAL 20170919 UNAPPROVED DRUG OTHER Westminster Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 38; 9 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 69367-157_e6467f80-687f-4cc2-8cb0-e7ea91288940 69367-157 HUMAN PRESCRIPTION DRUG Levothyroxine and Liothyronine Thyroid LEVOTHYROXINE and LIOTHYRONINE TABLET ORAL 20170919 UNAPPROVED DRUG OTHER Westminster Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 57; 13.5 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 69367-158_e6467f80-687f-4cc2-8cb0-e7ea91288940 69367-158 HUMAN PRESCRIPTION DRUG Levothyroxine and Liothyronine Thyroid LEVOTHYROXINE and LIOTHYRONINE TABLET ORAL 20171115 UNAPPROVED DRUG OTHER Westminster Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 76; 18 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 69367-159_e6467f80-687f-4cc2-8cb0-e7ea91288940 69367-159 HUMAN PRESCRIPTION DRUG Levothyroxine and Liothyronine Thyroid LEVOTHYROXINE and LIOTHYRONINE TABLET ORAL 20171115 UNAPPROVED DRUG OTHER Westminster Pharmaceuticals, LLC LEVOTHYROXINE; LIOTHYRONINE 9.5; 2.25 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 69367-160_a4008043-9ddf-47b9-956b-5c83d29e8dc0 69367-160 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20170824 UNAPPROVED DRUG OTHER Westminster Pharmaceuticals, LLC SALSALATE 500 mg/1 N 20181231 69367-161_a4008043-9ddf-47b9-956b-5c83d29e8dc0 69367-161 HUMAN PRESCRIPTION DRUG Salsalate Salsalate TABLET, FILM COATED ORAL 20170824 UNAPPROVED DRUG OTHER Westminster Pharmaceuticals, LLC SALSALATE 750 mg/1 N 20181231 69367-162_40fabd63-5616-2137-e054-00144ff88e88 69367-162 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, FILM COATED ORAL 20161110 UNAPPROVED DRUG OTHER Westminster Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 69367-163_40fabd63-5616-2137-e054-00144ff88e88 69367-163 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, FILM COATED ORAL 20161110 UNAPPROVED DRUG OTHER Westminster Pharmaceuticals, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 69367-180_61788f24-a30f-4385-a080-a28cd42e90ec 69367-180 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20171121 ANDA ANDA203769 Westminster Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 69367-181_61788f24-a30f-4385-a080-a28cd42e90ec 69367-181 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20171121 ANDA ANDA203769 Westminster Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 69367-182_61788f24-a30f-4385-a080-a28cd42e90ec 69367-182 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20171121 ANDA ANDA203769 Westminster Pharmaceuticals, LLC METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 69368-2454_0da2ef1a-c411-6168-e054-00144ff8d46c 69368-2454 HUMAN OTC DRUG Skin Tag Solution Thuja occidentalis LIQUID TOPICAL 20150401 UNAPPROVED HOMEOPATHIC VITACOST.COM, INC. THUJA OCCIDENTALIS WHOLE 6 [hp_X]/100mL E 20171231 69370-010_ca5087ed-03ea-400a-a76a-8bfc867db989 69370-010 HUMAN OTC DRUG THE BLUE TOOTHBRUSH SODIUM FLUORIDE GEL, DENTIFRICE TOPICAL 20141201 OTC MONOGRAPH FINAL part355 New-Light Co., Ltd SODIUM FLUORIDE .0002 g/251 E 20171231 69370-020_2f668e52-11d2-4022-9b2d-e966f0af4d18 69370-020 HUMAN OTC DRUG The White Toothbrush Sodium Fluoride GEL, DENTIFRICE TOPICAL 20150102 OTC MONOGRAPH FINAL part355 New-Light Co., Ltd SODIUM FLUORIDE .0002 g/251 E 20171231 69375-001_20418921-2142-4a85-8cf3-08ccda0d5b8e 69375-001 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20150301 ANDA ANDA078391 Nationwide Pharmaceutical, LLC HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69379-001_1a4e1221-85ef-3579-e054-00144ff88e88 69379-001 HUMAN PRESCRIPTION DRUG Simanix Simanix Pain Relieving Cream CREAM TOPICAL 20150708 UNAPPROVED DRUG OTHER Home Aide Diagnostics, Inc. CAPSAICIN; MENTHOL; HISTAMINE DIHYDROCHLORIDE .0375; 3; .035 g/100g; g/100g; g/100g E 20171231 69379-002_1a8bb57d-956d-260a-e054-00144ff8d46c 69379-002 HUMAN PRESCRIPTION DRUG Rematex Rematex Pain Relieiving Cream CREAM TOPICAL 20150710 UNAPPROVED DRUG OTHER Home Aide Diganostics, Inc. MENTHOL; CAPSAICIN; METHYL SALICYLATE 6; .035; 30 g/100g; g/100g; g/100g E 20171231 69379-004_1ac45dcf-6101-1a8b-e054-00144ff8d46c 69379-004 HUMAN PRESCRIPTION DRUG Veltrix Veltrix Pain Relieiving Cream CREAM TOPICAL 20150701 UNAPPROVED DRUG OTHER Home Aide Diagnostics, Inc. LIDOCAINE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 69379-010_10dfa403-1c1a-6374-e054-00144ff8d46c 69379-010 HUMAN PRESCRIPTION DRUG Permavan External Patch Permavan External Patch PATCH TOPICAL 20150309 UNAPPROVED DRUG OTHER Home Aide Diagnostics, Inc. TROLAMINE SALICYLATE; LIDOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 10; 4; 4 g/100g; g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA] E 20171231 69379-012_1a4c0e56-b4cb-682b-e054-00144ff88e88 69379-012 HUMAN OTC DRUG Rematex Rematex Pain RelievingCream CREAM TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part348 Home Aide Diagnostics, Inc. MENTHOL; HISTAMINE DIHYDROCHLORIDE; CAPSAICIN 3; .035; .0375 g/100g; g/100g; g/100g E 20171231 69379-013_1a4dfef7-a7ad-2142-e054-00144ff8d46c 69379-013 HUMAN PRESCRIPTION DRUG Simanix Simanix Pain Relieving Cream CREAM TOPICAL 20150708 UNAPPROVED DRUG OTHER Home Aide Diagnostics, Inc. CAPSAICIN; MENTHOL; HISTAMINE DIHYDROCHLORIDE .0357; 3; .035 g/100g; g/100g; g/100g E 20171231 69379-014_0ca0aa7b-90fa-18b7-e054-00144ff8d46c 69379-014 HUMAN PRESCRIPTION DRUG Lorenza Pain Relief Patch Lorenza Pain Relief Patch PATCH TOPICAL 20150101 UNAPPROVED DRUG OTHER Home Aide Diagnostics, Inc. LIDOCAINE; MENTHOL 4; 1 g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 69379-016_093efd77-4070-2006-e054-00144ff88e88 69379-016 HUMAN PRESCRIPTION DRUG Velma Pain Relief Patch Velma Pain Relief Patch PATCH TOPICAL 20141118 UNAPPROVED DRUG OTHER Home Aide Diagnostics, Inc. LIDOCAINE; MENTHOL; METHYL SALICYLATE 4; 2; 16 g/100g; g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 69379-035_1a8b55af-1cf1-1567-e054-00144ff88e88 69379-035 HUMAN OTC DRUG Rematex Rematex Pain RelievingCream CREAM TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part348 Home Aide Diagnostics, Inc. MENTHOL; METHYL SALICYLATE; CAPSAICIN 6; 30; .035 g/100g; g/100g; g/100g E 20171231 69379-037_093edffd-e151-5f8e-e054-00144ff8d46c 69379-037 HUMAN PRESCRIPTION DRUG Silvera Pain Relief Patch Silvera Pain Relief Patch PATCH TOPICAL 20141118 UNAPPROVED DRUG OTHER Home Aide Diagnostics, Inc. LIDOCAINE; CAPSAICIN; MENTHOL 1; .0375; 5 g/100g; g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 69379-037_17261c31-21ab-5e21-e054-00144ff88e88 69379-037 HUMAN OTC DRUG Silvera Pain Relief Patch Silvera Pain Relief Patch PATCH TRANSDERMAL 20150528 OTC MONOGRAPH NOT FINAL part348 Home Aide Diagnostics, Inc. CAPSAICIN; LIDOCAINE; MENTHOL .0375; 1; 5 g/100g; g/100g; g/100g E 20171231 69379-038_1c834710-1287-3266-e054-00144ff8d46c 69379-038 HUMAN OTC DRUG Rotex Rotex Pain Relieving Cream CREAM TOPICAL 20150810 OTC MONOGRAPH NOT FINAL part348 Home Aide Diagnostics, Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 35; 4; .038 g/100g; g/100g; g/100g E 20171231 69379-285_10e0247a-5ffe-064e-e054-00144ff8d46c 69379-285 HUMAN PRESCRIPTION DRUG Remaxazon External Patch Remaxazon External Patch PATCH TOPICAL 20150309 UNAPPROVED DRUG OTHER Home Aide Diagnostics, Inc. CHONDROITIN SULFATE SODIUM (BOVINE); CAPSAICIN; LIDOCAINE; GLUCOSAMINE 3; .0285; 4; 5 g/100g; g/100g; g/100g; g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 69379-400_1bf5cf24-88ec-1ade-e054-00144ff8d46c 69379-400 HUMAN PRESCRIPTION DRUG Co-Veratrol Co-Veratrol CAPSULE ORAL 20150801 UNAPPROVED DRUG OTHER Home Aide Diagnostics, Inc. UBIQUINOL; METHYLCOBALAMIN; RESVERATROL; FOLIC ACID 200; 5; 400; .8 mg/mg; mg/mg; mg/mg; mg/mg E 20171231 69381-2500_e19f65cd-0b11-410c-aa62-2d332c9339e2 69381-2500 HUMAN OTC DRUG Raw Ice menthol GEL TOPICAL 20141218 OTC MONOGRAPH NOT FINAL part348 Rescue Dog Health MENTHOL 3.5 mg/L N 20181231 69381-2501_7891d767-c934-4e5f-ac35-2e7c4d04ad81 69381-2501 HUMAN OTC DRUG Raw Heat menthol GEL TOPICAL 20141218 OTC MONOGRAPH NOT FINAL part348 Rescue Dog Health MENTHOL 3.5 mg/L N 20181231 69384-010_32b8c4a4-aa85-4532-818b-b7eaf71ff06d 69384-010 HUMAN OTC DRUG HAIRJOY PYRITHIONE ZINC SHAMPOO TOPICAL 20141001 OTC MONOGRAPH FINAL part358H HAIRJOY PYRITHIONE ZINC 6 mg/300mL N 20181231 69384-020_2692f18d-8afe-4258-97db-d61e48c9e7b1 69384-020 HUMAN OTC DRUG HAIRJOY TONIC Allantoin SOLUTION TOPICAL 20141001 OTC MONOGRAPH FINAL part347 HAIRJOY ALLANTOIN .96 mg/120mL N 20181231 69384-030_c2d3ca81-ac57-474c-adf8-875aa245cdc7 69384-030 HUMAN OTC DRUG HAIRJOY HAIR ESSENCE Allantoin SOLUTION TOPICAL 20161001 OTC MONOGRAPH FINAL part347 HAIRJOY ALLANTOIN .96 g/120mL N 20181231 69387-100_ac286359-2ef9-44c7-aa7d-6ed9120debfe 69387-100 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20150907 ANDA ANDA078720 Banner Life Sciences LLC. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] E 20171231 69387-101_58540e8a-1bbd-4ab4-8efa-67f55e62fc1c 69387-101 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20151001 ANDA ANDA200900 Banner Life Sciences LLC. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 69387-102_58540e8a-1bbd-4ab4-8efa-67f55e62fc1c 69387-102 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20151001 ANDA ANDA200900 Banner Life Sciences LLC. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 69387-103_f529b1d8-ba53-42f1-9cc4-5767f63a043d 69387-103 HUMAN PRESCRIPTION DRUG PARICALCITOL PARICALCITOL CAPSULE ORAL 20150902 ANDA ANDA202539 Banner Life Sciences LLC. PARICALCITOL 1 mg/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 69387-104_f529b1d8-ba53-42f1-9cc4-5767f63a043d 69387-104 HUMAN PRESCRIPTION DRUG PARICALCITOL PARICALCITOL CAPSULE ORAL 20151001 ANDA ANDA202539 Banner Life Sciences LLC. PARICALCITOL 2 mg/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 69387-105_f529b1d8-ba53-42f1-9cc4-5767f63a043d 69387-105 HUMAN PRESCRIPTION DRUG PARICALCITOL PARICALCITOL CAPSULE ORAL 20151001 ANDA ANDA202539 Banner Life Sciences LLC. PARICALCITOL 4 mg/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] E 20171231 69387-106_07877b15-35b1-480f-8ea3-2cdab75e3c58 69387-106 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20150601 ANDA ANDA080704 Banner Life Sciences LLC. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] E 20171231 69387-107_7ee2991b-80bf-45fd-a487-6f07bb1dba07 69387-107 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE, LIQUID FILLED ORAL 20150601 ANDA ANDA073484 Banner Life Sciences LLC. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 69387-108_287c9c89-005d-494c-835c-9b7f19db00e8 69387-108 HUMAN PRESCRIPTION DRUG Ethosuximide Ethosuximide CAPSULE, LIQUID FILLED ORAL 20150601 ANDA ANDA040430 Banner Life Sciences LLC. ETHOSUXIMIDE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69387-119_e60439e5-5de9-4b39-9617-c2e471da7e56 69387-119 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20150601 ANDA ANDA081297 Banner Life Sciences LLC. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 69387-120_e60439e5-5de9-4b39-9617-c2e471da7e56 69387-120 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20150601 ANDA ANDA081297 Banner Life Sciences LLC. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 69388-1001_e81880b1-eb47-4a06-92fd-727a780c864e 69388-1001 HUMAN OTC DRUG LANCELL HUITOMO HAIR LOSS PREVENTION HAIR GROWER CLEAN FORMULA PYRITHIONE ZINC LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part358H Lancell Bio Co., Ltd. PYRITHIONE ZINC 2.1 g/100mL E 20171231 69388-2001_ea13edcf-20dc-44d9-aace-84a33da79c5b 69388-2001 HUMAN OTC DRUG LANCELL HUITOMO HAIR LOSS PREVENTION HAIR GROWING TONIC SALICYLIC ACID LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part358H Lancell Bio Co., Ltd. SALICYLIC ACID .5 g/100mL E 20171231 69388-3001_5a514bd1-616b-4187-8914-7426107f5880 69388-3001 HUMAN OTC DRUG HUITOMI GLYCERIN CREAM TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Lancell Bio Co., Ltd. GLYCERIN 5 g/100mL E 20171231 69388-4001_cb526852-6c4d-4468-a97f-726165f4b10d 69388-4001 HUMAN OTC DRUG HUITOMI SLIMMING SPORTS MENTHOL GEL TOPICAL 20141101 OTC MONOGRAPH FINAL part341 Lancell Bio Co., Ltd. MENTHOL .3 g/100mL E 20171231 69388-5001_4dabaab6-b0ba-4a7b-96db-b53ded67c014 69388-5001 HUMAN OTC DRUG HUITOMI SERUM GLYCERIN LIQUID TOPICAL 20141101 OTC MONOGRAPH FINAL part347 Lancell Bio Co., Ltd. GLYCERIN 5 g/100mL E 20171231 69388-6001_dc47fd0d-fdaa-4ce5-8023-f0b8d03500e3 69388-6001 HUMAN OTC DRUG HUITOMI PACK GLYCERIN CREAM TOPICAL 20150420 OTC MONOGRAPH FINAL part347 Lancell Bio Co., Ltd. GLYCERIN 5 g/100mL E 20171231 69390-001_45214318-ee23-4f36-affa-0256101b9c9b 69390-001 HUMAN OTC DRUG EAR RX Aconitum nap, Baryta carb, Belladonna, Calc carb, Capsicum, Carbo veg, Causticum, Chamomilla, Ferrum phos, Hepar sulph calc, Kali mur, Lachesis, Lycopodium, Mercurius sol, Natrum mur, Plantago, Pulsatilla, Silicea, Sulphur, Verbascum LIQUID ORAL 20151123 UNAPPROVED HOMEOPATHIC Miami Beach Pediatrics pa ACONITUM NAPELLUS; BARIUM CARBONATE; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; ACTIVATED CHARCOAL; CAUSTICUM; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; CALCIUM SULFIDE; POTASSIUM CHLORIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; SODIUM CHLORIDE; PLANTAGO MAJOR; PULSATILLA VULGARIS; SILICON DIOXIDE; SULFUR; VERBASCUM THAPSUS 6; 10; 9; 6; 9; 12; 8; 9; 9; 10; 10; 8; 6; 12; 6; 9; 9; 9; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69390-002_6c6d2822-296a-47ba-b40c-b02573713824 69390-002 HUMAN OTC DRUG SINUS RX Calcarea carb, Euphorbium, Hydrastis, Kali bic, Kali iod, Lycopodium, Phosphorus, Pulsatilla, Thuja occ, Sanguinaria LIQUID ORAL 20151123 UNAPPROVED HOMEOPATHIC Miami Beach Pediatrics pa OYSTER SHELL CALCIUM CARBONATE, CRUDE; EUPHORBIA RESINIFERA RESIN; GOLDENSEAL; POTASSIUM DICHROMATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG; SANGUINARIA CANADENSIS ROOT 9; 6; 6; 9; 8; 6; 10; 4; 6; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69392-001_946328f8-56db-4928-b767-30f65e8114fc 69392-001 HUMAN OTC DRUG PremierPro Fluoride Tooth SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20150101 OTC MONOGRAPH FINAL part355 SVS, LLC (DBA S2S Global) SODIUM MONOFLUOROPHOSPHATE .1 g/100g E 20171231 69392-901_621793d7-3fda-5379-e053-2a91aa0a11c8 69392-901 HUMAN OTC DRUG Flushable wipes Dimethicone GEL TOPICAL 20170729 OTC MONOGRAPH FINAL part347 SVS, LLC (DBA S2S Global) DIMETHICONE 3.2 g/100g N 20191231 69396-001_5e6c47dc-fcf5-0509-e053-2a91aa0a1eb4 69396-001 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM TOPICAL 20150310 OTC MONOGRAPH FINAL part333C TRIFECTA PHARMACEUTICALS USA LLC CLOTRIMAZOLE 1 g/100g N 20181231 69396-002_5e6d98fd-609b-530c-e053-2a91aa0a5122 69396-002 HUMAN OTC DRUG Triple Antibiotic Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate. OINTMENT TOPICAL 20150310 OTC MONOGRAPH FINAL part333B TRIFECTA PHARMACEUTICALS USA LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 69396-003_5e6c7b57-87ad-8a25-e053-2991aa0ab871 69396-003 HUMAN OTC DRUG Hydrocortisone HYDROCORTISONE OINTMENT TOPICAL 20150310 OTC MONOGRAPH NOT FINAL part348 TRIFECTA PHARMACEUTICALS USA LLC HYDROCORTISONE 1 g/100g N 20181231 69396-004_5e6d84b5-b88b-a763-e053-2991aa0a4ff6 69396-004 HUMAN OTC DRUG Ichthammol 20% Ichthammol OINTMENT TOPICAL 20150712 UNAPPROVED HOMEOPATHIC TRIFECTA PHARMACEUTICALS USA LLC ICHTHAMMOL 20 g/100g N 20181231 69396-005_36d67433-5721-43de-9598-368c7a0076bb 69396-005 HUMAN OTC DRUG Hydrocortisone 1% with healing aloe Hydrocortisone CREAM TOPICAL 20151223 OTC MONOGRAPH NOT FINAL part348 Trifecta Pharmaceuticals Usa Llc HYDROCORTISONE 1 g/100g E 20171231 69396-006_4048ff97-3acc-49b3-a785-ea2d24176123 69396-006 HUMAN OTC DRUG MA YING LONG HEMORRHOIDAL Moschus Artifactus, Bovis Calculus Artifactus, Margarita, Borneolum Syntheticum, Succinum, Calamina (Calcined), Borax OINTMENT TOPICAL 20160114 UNAPPROVED DRUG OTHER Trifecta Pharmaceuticals Usa Llc MOSCHUS BEREZOVSKII MUSK SAC RESIN; BOS TAURUS GALLSTONE; PEARL (HYRIOPSIS CUMINGII); BORNEOL; AMBER; ZINC CARBONATE; SODIUM BORATE .15; .1; .25; .2; .1; .65; .2 g/10g; g/10g; g/10g; g/10g; g/10g; g/10g; g/10g E 20171231 69396-008_dd2f31bd-101d-4f40-bfbf-fe7d26004471 69396-008 HUMAN OTC DRUG Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20160407 OTC MONOGRAPH FINAL part333B Trifecta Pharmaceuticals Usa Llc BACITRACIN ZINC 500 [USP'U]/g E 20171231 69396-009_453dffec-de9e-0eac-e054-00144ff8d46c 69396-009 HUMAN OTC DRUG Vitamin A and D Lanolin, Petrolatum OINTMENT TOPICAL 20170103 OTC MONOGRAPH FINAL part347 Trifecta Pharmaceuticals USA LLC PETROLATUM; LANOLIN 53.4; 15.5 g/100g; g/100g N 20181231 69396-014_5e6c7b57-87ba-8a25-e053-2991aa0ab871 69396-014 HUMAN OTC DRUG MICONAZOLE Nitrate 2% Cream ANTIFUNGAL MICONAZOLE NITRATE CREAM TOPICAL 20160322 OTC MONOGRAPH FINAL part333C Trifecta Pharmaceuticals Usa Llc MICONAZOLE NITRATE 2 g/100g N 20181231 69396-015_5e6d7e40-f65e-732c-e053-2991aa0acb29 69396-015 HUMAN OTC DRUG Triple Antibiotic Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate OINTMENT TOPICAL 20160318 OTC MONOGRAPH FINAL part333B Trifecta Pharmaceuticals Usa Llc BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 69396-016_5e6ceae2-c816-7268-e053-2a91aa0a6f15 69396-016 HUMAN OTC DRUG Tolnaftate Cream 1% ANTIFUNGAL Tolnaftate CREAM TOPICAL 20160409 OTC MONOGRAPH FINAL part333C Trifecta Pharmaceuticals Usa Llc TOLNAFTATE 1 g/100g N 20181231 69396-017_5e6c9460-12fb-0d34-e053-2a91aa0adcd4 69396-017 HUMAN OTC DRUG Hydrocortisone 1% Hydrocortisone OINTMENT TOPICAL 20160409 OTC MONOGRAPH NOT FINAL part348 Trifecta Pharmaceuticals Usa Llc HYDROCORTISONE 1 g/100g N 20181231 69396-018_5e6cba85-9dff-1d20-e053-2a91aa0ad7c6 69396-018 HUMAN OTC DRUG Vitamin A and D Lanolin, Petrolatum OINTMENT TOPICAL 20170105 OTC MONOGRAPH FINAL part347 Trifecta Pharmaceuticals USA LLC PETROLATUM; LANOLIN 53.4; 15.5 g/100g; g/100g N 20181231 69396-020_5e6c9460-1307-0d34-e053-2a91aa0adcd4 69396-020 HUMAN OTC DRUG HemorrhoidalOintment Mineral Oil, Petrolatum, Phenylephrine HCI OINTMENT TOPICAL 20170504 OTC MONOGRAPH FINAL part346 Trifecta Pharmaceuticals USA LLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 69396-020_5e6d610f-dad9-0f1f-e053-2a91aa0a3efb 69396-020 HUMAN OTC DRUG HemorrhoidalOintment Mineral Oil, Petrolatum, Phenylephrine HCI OINTMENT TOPICAL 20161229 OTC MONOGRAPH FINAL part346 Trifecta Pharmaceuticals Usa Llc PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL; PETROLATUM .25; 14; 74.9 g/100g; g/100g; g/100g N 20181231 69396-021_63aed61d-57eb-5c6e-e053-2991aa0a282e 69396-021 HUMAN OTC DRUG Zinc Oxide 20% Zinc Oxide OINTMENT TOPICAL 20180104 OTC MONOGRAPH FINAL part347 Trifecta Pharmaceuticals USA ZINC OXIDE .2 g/g N 20191231 69396-021_63b551fc-7d17-c099-e053-2a91aa0a5f2c 69396-021 HUMAN OTC DRUG Zinc Oxide 20% Zinc Oxide OINTMENT TOPICAL 20180126 OTC MONOGRAPH FINAL part347 Trifecta Pharmaceuticals USA ZINC OXIDE .2 g/g N 20191231 69396-024_5e6ceae2-c7f6-7268-e053-2a91aa0a6f15 69396-024 HUMAN OTC DRUG Muscle Rub Cream Menthol 10%, Methyl Salicylate 15% CREAM TOPICAL 20161229 OTC MONOGRAPH NOT FINAL part348 Trifecta Pharmaceuticals USA, LLC. MENTHOL; METHYL SALICYLATE .1; .15 g/100g; g/100g N 20181231 69396-025_5e6ceae2-c804-7268-e053-2a91aa0a6f15 69396-025 HUMAN OTC DRUG Anti-Itch Cream Diphenhydramine hydrochloride 2%, zinc acetate 0.1% CREAM TOPICAL 20161229 OTC MONOGRAPH FINAL part347 Trifecta Pharmaceuticals USA, LLC. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 69396-027_5e6c9460-1326-0d34-e053-2a91aa0adcd4 69396-027 HUMAN OTC DRUG Bacitracin Bacitracin Zinc OINTMENT TOPICAL 20170315 OTC MONOGRAPH FINAL part333B Trifecta Pharmaceuticals USA, LLC. BACITRACIN ZINC 500 [USP'U]/g N 20181231 69396-028_5e6c9460-1319-0d34-e053-2a91aa0adcd4 69396-028 HUMAN OTC DRUG Hydrocortisone Cream Hydrocortisone CREAM TOPICAL 20170407 OTC MONOGRAPH NOT FINAL part348 Trifecta Pharmaceuticals USA HYDROCORTISONE 1 g/100g N 20181231 69396-029_5e6c55a0-c0b4-d47f-e053-2a91aa0ac982 69396-029 HUMAN OTC DRUG doubleantibioticointment bacitracin zinc, polymyxin B sulfate OINTMENT TOPICAL 20170504 OTC MONOGRAPH FINAL part333B Trifecta Pharmaceuticals USA LLC POLYMYXIN B SULFATE; BACITRACIN ZINC 10000; 500 [USP'U]/g; [USP'U]/g N 20181231 69396-030_5e6c47dc-fcde-0509-e053-2a91aa0a1eb4 69396-030 HUMAN OTC DRUG Tripleantibioticointmentandpainrelief Bacitracin,Neomycin,Polymxin, Pramoxine OINTMENT TOPICAL 20170720 OTC MONOGRAPH FINAL part333B Trifecta Pharmaceuticals USA BACITRACIN; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE 500; 3.5; 10; 10000 [USP'U]/100g; mg/100g; mg/100g; [USP'U]/100g N 20181231 69396-031_5e6c922e-5085-2c7f-e053-2a91aa0acc54 69396-031 HUMAN OTC DRUG Rhuli Gel Camphor, Menthol GEL TOPICAL 20170517 OTC MONOGRAPH FINAL part341 Trifecta Pharmaceuticals USA, LLC. CAMPHOR (SYNTHETIC); MENTHOL .3; .3 g/100g; g/100g N 20181231 69397-156_5040bcac-d225-40fb-9cb3-607025aad3de 69397-156 HUMAN OTC DRUG FlexxSonic Pain Relief Capsaicin GEL TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part348 Flexxsonic Corporation CAPSAICIN .25 mg/g N 20181231 69398-101_3be98111-6461-4e65-a521-280abe473ee1 69398-101 HUMAN OTC DRUG Qelby Healing Food Red Ginseng CAPSULE ORAL 20141222 UNAPPROVED DRUG OTHER Quantum Energy Co., Ltd. ASIAN GINSENG .05 g/1 E 20171231 69399-182_60e78359-8a1a-46d9-ac69-99dd891ea233 69399-182 HUMAN PRESCRIPTION DRUG Celecoxib 50 mg CELECOXIB CAPSULE ORAL 20151124 ANDA ANDA204519 SYDON LABS LLC CELECOXIB 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69399-183_32296228-f1f7-4272-b8d4-affca2a3d287 69399-183 HUMAN PRESCRIPTION DRUG Celecoxib 100 mg CELECOXIB CAPSULE ORAL 20151124 ANDA ANDA204519 SYDON LABS LLC CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69399-184_de60c3d4-4f29-4718-8e1d-3b26f2661bdb 69399-184 HUMAN PRESCRIPTION DRUG Celecoxib 200 mg CELECOXIB CAPSULE ORAL 20151124 ANDA ANDA204519 SYDON LABS LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69399-185_693a271d-9908-4fdc-bccf-15465bdd8b02 69399-185 HUMAN PRESCRIPTION DRUG Celecoxib 400 mg CELECOXIB CAPSULE ORAL 20151124 ANDA ANDA204519 SYDON LABS LLC CELECOXIB 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69399-194_cf5aa65e-7b73-495d-9115-efd878f259c5 69399-194 HUMAN PRESCRIPTION DRUG Celecoxib 200 mg CELECOXIB CAPSULE ORAL 20170317 ANDA ANDA204519 SYDON LABS LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69401-000_59d35789-5090-4b92-bbbd-50dd38885d9c 69401-000 VACCINE Vivotif Salmonella typhi Ty21a CAPSULE, COATED ORAL 19920316 BLA BLA103123 PaxVax Berna GmbH SALMONELLA TYPHI TY21A LIVE ANTIGEN 6000000000 [CFU]/1 Live Attenuated Salmonella Typhi Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Typhoid [Chemical/Ingredient],Vaccines, Attenuated [Chemical/Ingredient] N 20181231 69402-011_09e4b381-5934-58c3-e054-00144ff8d46c 69402-011 HUMAN OTC DRUG BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141210 OTC MONOGRAPH NOT FINAL part333E SANI PRODUCTS INC. BENZALKONIUM CHLORIDE .13 g/mL E 20171231 69402-012_0a1a4ca8-e3fa-161c-e054-00144ff8d46c 69402-012 HUMAN OTC DRUG BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20141213 OTC MONOGRAPH NOT FINAL part333E SANI PRODUCTS INC. BENZALKONIUM CHLORIDE .13 g/mL E 20171231 69404-010_e6eab4f4-4670-4be4-bbd1-888105554b0c 69404-010 HUMAN OTC DRUG CLARA 1984 DIMETHICONE CREAM TOPICAL 20141220 OTC MONOGRAPH FINAL part347 CLARA GROUP DIMETHICONE .5 mg/50mL E 20171231 69405-001_dd23d0f8-9055-4ed1-94dc-d97de74eeba6 69405-001 HUMAN OTC DRUG Seniorclean Bio Allantoin, Glycerin GEL TOPICAL 20150202 UNAPPROVED DRUG OTHER DoctorQ Co., Ltd. ALLANTOIN; GLYCERIN .12; 6 mg/600mL; mg/600mL E 20171231 69406-001_c6482ef6-b697-4382-89c1-45040e4230e9 69406-001 HUMAN PRESCRIPTION DRUG Cedar Fever ONION - FRAXINUS AMERICANA BARK - GALPHIMIA GLAUCA FLOWERING TOP - JUNIPERUS VIRGINIANA TWIG - QUERCUS ROBUR TWIG BARK - THUJA PLICATA LEAF - ULMUS RUBRA BARK PELLET ORAL 20151123 UNAPPROVED HOMEOPATHIC People's Pharmacy, Inc ONION; FRAXINUS AMERICANA BARK; GALPHIMIA GLAUCA FLOWERING TOP; JUNIPERUS VIRGINIANA TWIG; QUERCUS ROBUR TWIG BARK; THUJA PLICATA LEAF; ULMUS RUBRA BARK 6; 6; 6; 6; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Vegetable Proteins [Chemical/Ingredient] E 20171231 69406-002_f0456008-339e-4c07-8e46-6e047d9fcebd 69406-002 HUMAN OTC DRUG Cedar Fever ONION - FRAXINUS AMERICANA BARK - GALPHIMIA GLAUCA FLOWERING TOP - JUNIPERUS VIRGINIANA TWIG - QUERCUS ROBUR TWIG BARK - THUJA PLICATA LEAF - ULMUS RUBRA BARK LIQUID ORAL 20151228 UNAPPROVED HOMEOPATHIC People's Pharmacy, Inc ONION; FRAXINUS AMERICANA BARK; GALPHIMIA GLAUCA FLOWERING TOP; JUNIPERUS VIRGINIANA TWIG; QUERCUS ROBUR TWIG BARK; THUJA PLICATA LEAF; ULMUS RUBRA BARK 6; 6; 6; 6; 6; 6; 6 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL E 20171231 69410-0001_f08d9c42-e1fe-41a7-98d1-3bbf2dcb5490 69410-0001 HUMAN OTC DRUG Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20141126 OTC MONOGRAPH NOT FINAL part333E PrimeCare + Inc. ALCOHOL 75 mL/100mL N 20181231 69412-001_8b0702a0-0582-4313-a7b8-371f54638552 69412-001 HUMAN OTC DRUG Royal King Pain Relief Patch Camphor PATCH TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part348 Tianshui Weishi Tongtai Pharmaceutical Co Ltd CAMPHOR (SYNTHETIC) .13 g/100g N 20181231 69413-330_38325135-541d-4fc0-bef8-88be76fb3425 69413-330 HUMAN PRESCRIPTION DRUG Daraprim pyrimethamine TABLET ORAL 19530123 NDA NDA008578 Vyera Pharmaceuticals LLC PYRIMETHAMINE 25 mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] N 20181231 69413-558_6d7d4f9f-6aad-407c-9565-a9800a2ac1aa 69413-558 HUMAN PRESCRIPTION DRUG Vecamyl Mecamylamine Hydrochloride TABLET ORAL 20130319 ANDA ANDA204054 Turing Pharmaceuticals MECAMYLAMINE HYDROCHLORIDE 2.5 mg/1 Autonomic Ganglionic Blocker [EPC],Decreased Autonomic Ganglionic Activity [PE] N 20181231 69414-0001_be0b8d9b-00da-4937-9be2-81ee6dc2ac33 69414-0001 HUMAN OTC DRUG LIVER ALIGN CHELIDONIUM MAJUS, CHOLESTERINUM, ARSENICUM ALBUM, BELLADONNA, LYCOPODIUM CLAVATUM, TARENTULA HISPANA LIQUID ORAL 20141210 UNAPPROVED HOMEOPATHIC Evolution CHELIDONIUM MAJUS; CHOLESTEROL; ARSENIC TRIOXIDE; ATROPA BELLADONNA; LYCOPODIUM CLAVATUM SPORE; LYCOSA TARANTULA 3; 30; 1; 1; 1; 10 [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 69414-0002_86ca31e2-0e95-43fa-bbcf-a3151ca6b362 69414-0002 HUMAN OTC DRUG GALLBLADDER ALIGN FEL TAURI, CHIONANTHUS VIRGINICA, ARSENICUM ALBUM, NUX VOMICA, PLATINUM METALLICUM LIQUID ORAL 20141211 UNAPPROVED HOMEOPATHIC Evolution BOS TAURUS BILE; CHIONANTHUS VIRGINICUS BARK; ARSENIC TRIOXIDE; STRYCHNOS NUX-VOMICA SEED; PLATINUM 3; 30; 1; 1; 1 [hp_X]/mL; [hp_C]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL N 20181231 69415-001_2232d91b-f709-47a3-9e79-671abfc31bd9 69415-001 HUMAN PRESCRIPTION DRUG Vapergy caffeine, green tea, american ginseng SPRAY ORAL 20141218 UNAPPROVED HOMEOPATHIC Keen Flow International Limited CAFFEINE; GREEN TEA LEAF; AMERICAN GINSENG 1; 1; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 69415-002_9daaee18-805c-4ddc-a338-ad0f6a121215 69415-002 HUMAN PRESCRIPTION DRUG Vapergy Slim bitter orange, caffeine, green tea, peppermint camphor SPRAY ORAL 20141218 UNAPPROVED HOMEOPATHIC Keen Flow International Limited CAFFEINE; BITTER ORANGE OIL; GREEN TEA LEAF; MENTHOL, UNSPECIFIED FORM 1; 6; 6; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 69417-100_1285da82-49bf-23e0-e054-00144ff8d46c 69417-100 HUMAN OTC DRUG INDIGO soothing triple recovery cream Colloidal Oatmeal LOTION TOPICAL 20150330 OTC MONOGRAPH FINAL part347 TATCHA INC. OATMEAL 3 g/50g E 20171231 69417-100_18a20dca-9587-0070-e054-00144ff8d46c 69417-100 HUMAN OTC DRUG INDIGO soothing triple recovery cream Colloidal Oatmeal LOTION TOPICAL 20150616 OTC MONOGRAPH FINAL part347 TATCHA INC. OATMEAL 3 g/50g E 20171231 69417-110_17765021-dbc9-07f5-e054-00144ff88e88 69417-110 HUMAN OTC DRUG SILKEN pore perfecting sunscreen broad spectrum SPF 35 Octisalate, Zinc Oxide LOTION TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 TATCHA INC. OCTISALATE; ZINC OXIDE 5; 15 g/100g; 1/100g E 20171231 69417-110_1776ab96-88a8-5981-e054-00144ff8d46c 69417-110 HUMAN OTC DRUG SILKEN pore perfecting sunscreen broad spectrum SPF 35 Octisalate, Zinc Oxide LOTION TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 TATCHA INC. OCTISALATE; ZINC OXIDE 5; 15 g/100g; 1/100g E 20171231 69418-000_0dabc91b-92c1-34d2-e054-00144ff8d46c 69418-000 HUMAN OTC DRUG patch menthol and capsaicin PATCH TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part348 Meds Direct Rx of NY LLC MENTHOL 5 g/100g E 20171231 69418-002_24d86c23-664b-00dc-e054-00144ff8d46c 69418-002 HUMAN OTC DRUG BenePatch LIDOCAINE HYDROCHLORIDE, MENTHOL PATCH TOPICAL 20150124 OTC MONOGRAPH NOT FINAL part348 Meds Direct Rx, Inc. MENTHOL; LIDOCAINE HYDROCHLORIDE 1; 4 g/100g; g/100g E 20171231 69418-003_24d867c0-ac2a-683c-e054-00144ff8d46c 69418-003 HUMAN OTC DRUG AmeriPatch menthol and capsaicin PATCH TOPICAL 20150131 OTC MONOGRAPH NOT FINAL part348 Meds Direct Rx, Inc. MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g E 20171231 69418-004_24d86c23-6655-00dc-e054-00144ff8d46c 69418-004 HUMAN OTC DRUG Elite PAIN RELIEF ALLANTOIN, LIDOCAINE, PETROLATUM PATCH TOPICAL 20150505 OTC MONOGRAPH FINAL part347 Meds Direct Rx, Inc. ALLANTOIN; LIDOCAINE; PETROLATUM 2; 4; 30 g/100g; g/100g; g/100g E 20171231 69418-006_25d9728f-6a62-65ab-e054-00144ff8d46c 69418-006 HUMAN OTC DRUG Ricora LIDOCAINE HYDROCHLORIDE, MENTHOL PATCH TOPICAL 20151121 OTC MONOGRAPH NOT FINAL part348 Meds Direct Rx, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 mg/g; mg/g E 20171231 69420-1001_db4f36bc-73ea-4e5b-a70d-f1572ef7120f 69420-1001 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20150325 ANDA ANDA078722 SA3, LLC CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 69420-4001_e3e881e6-3fbd-4d36-9dbd-210887fc03bf 69420-4001 HUMAN PRESCRIPTION DRUG BT bupivacaine hydrochloride, triamcinolone acetonide, povidone-iodine and isopropyl alcohol KIT 20150701 NDA NDA014901 SA3, LLC E 20171231 69420-4002_ff00dae7-b041-4bcd-9771-df9daa3341a0 69420-4002 HUMAN PRESCRIPTION DRUG LT lidocaine hydrochloride, triamcinolone acetonide, povidone-iodine and isopropyl alcohol KIT 20150701 NDA NDA014901 SA3, LLC E 20171231 69422-0101_77669a30-6d84-4133-8fca-288589408ced 69422-0101 HUMAN OTC DRUG CareCella Facial Line-up Tightening Serum GLYCERIN LIQUID TOPICAL 20150705 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. GLYCERIN 2 g/100mL N 20181231 69422-1001_b3242b0e-32da-433d-9597-1687f264b3c1 69422-1001 HUMAN OTC DRUG FACIAL LIFTING ALLANTOIN GEL TOPICAL 20141208 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. ALLANTOIN .1 g/100mL N 20181231 69422-1101_fae39532-aad6-4d07-bc77-25e4c5f4042b 69422-1101 HUMAN OTC DRUG CareCella VFB Bio Peel Serum GLYCERIN LIQUID TOPICAL 20150705 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. GLYCERIN 40 g/100mL N 20181231 69422-1201_3f2e0bb9-ac26-213c-e054-00144ff88e88 69422-1201 HUMAN OTC DRUG CareCella Facial Line-up Lifting GLYCERIN GEL TOPICAL 20150705 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. GLYCERIN .01 g/100mL N 20181231 69422-1301_edc440f0-d86d-4a9e-8d41-aec2cde1bb17 69422-1301 HUMAN OTC DRUG CareCella Hydration BB Cream Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20161215 OTC MONOGRAPH NOT FINAL part352 General Bio Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 70; 42 mg/g; mg/g; mg/g N 20181231 69422-1302_fd8192e1-5ede-45ed-b2ec-498b125c3225 69422-1302 HUMAN OTC DRUG CareCella Day Cream Avobenzone, Octinoxate, Octocrylene CREAM TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part352 General Bio Co., Ltd. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 3; 7.5; 7.5 g/100mL; g/100mL; g/100mL N 20181231 69422-1303_66b68e15-93ca-4d30-ad70-2da1165725c6 69422-1303 HUMAN OTC DRUG CareCella Velvet Cover BB Cream Dimethicone, Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part352 General Bio Co., Ltd. DIMETHICONE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 1; 5; 7.6; .98 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69422-2001_301c6f5d-af3b-4fa3-8991-8c58023df3c6 69422-2001 HUMAN OTC DRUG VFB BIO PEEL ALUMINUM OXIDE POWDER TOPICAL 20141209 UNAPPROVED DRUG OTHER General Bio Co., Ltd. ALUMINUM OXIDE 6.5 mg/g N 20181231 69422-3001_30d69684-4534-4ed3-a16f-239e63cc2709 69422-3001 HUMAN OTC DRUG AB DUO WHITENING A GLYCERIN SOLUTION TOPICAL 20141208 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. GLYCERIN 10 g/100mL N 20181231 69422-4001_f610c1d9-3e70-47cb-93f5-fd3b40b62246 69422-4001 HUMAN OTC DRUG P9 PHOTO CLEANSER GLYCERIN SOLUTION TOPICAL 20141208 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. GLYCERIN 69.8 g/100mL N 20181231 69422-5001_61840956-ea63-4855-b862-223d6327a39d 69422-5001 HUMAN OTC DRUG HYDRO H ARBUTIN SOLUTION TOPICAL 20141209 UNAPPROVED DRUG OTHER General Bio Co., Ltd. ARBUTIN 2.5 mg/mL N 20181231 69422-6001_5721e7fd-5943-4338-8e15-9ac623b6eb2d 69422-6001 HUMAN OTC DRUG POST CARE ALLANTOIN SOLUTION TOPICAL 20141208 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. ALLANTOIN .1 g/100mL N 20181231 69422-7001_a321eae5-f118-4258-9ba2-0455cfb9ce5c 69422-7001 HUMAN OTC DRUG CareCella Bodyshaper Warming GLYCERIN CREAM TOPICAL 20141208 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. GLYCERIN 2 g/100mL N 20181231 69422-8001_79433ecd-b2d7-4179-acc3-e5d9f5a32f83 69422-8001 HUMAN OTC DRUG CareCella Carboxy GLYCERIN GEL TOPICAL 20150705 OTC MONOGRAPH FINAL part347 General Bio Co., Ltd. GLYCERIN 5 g/100g N 20181231 69423-001_42af5190-0b23-0bdd-e054-00144ff8d46c 69423-001 HUMAN OTC DRUG Secret Clinical Strength Smooth Protection Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20150114 20180816 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-002_42af74f7-64dc-1574-e054-00144ff8d46c 69423-002 HUMAN OTC DRUG Secret Clinical Strength Smooth ooh la la lavender scent Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141215 20181109 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-003_42afc4c8-b1e9-2642-e054-00144ff8d46c 69423-003 HUMAN OTC DRUG Secret Clinical Strength Smooth Sport Fresh Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141215 20181107 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-004_42afc4c8-b1fa-2642-e054-00144ff8d46c 69423-004 HUMAN OTC DRUG Secret Clinical Strength Smooth Light and Fresh Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141215 20180722 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-005_42b1889c-9a09-0884-e054-00144ff8d46c 69423-005 HUMAN OTC DRUG Secret Clinical Strength Smooth Waterproof Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20150204 20180712 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-006_42b146ae-da89-71ad-e054-00144ff8d46c 69423-006 HUMAN OTC DRUG Secret Clinical Strength Smooth Mean Stinks Fearlessly Fresh Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141215 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-007_42b0dc72-a270-5dee-e054-00144ff8d46c 69423-007 HUMAN OTC DRUG Secret Clinical Strength Smooth Calming Aloe Scent Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20141215 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-008_42b1f397-4d37-1c6e-e054-00144ff8d46c 69423-008 HUMAN OTC DRUG Secret Clinical Strength Smooth Stress Response Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20150209 20180725 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-009_481a7bdd-ae66-704d-e054-00144ff8d46c 69423-009 HUMAN OTC DRUG Secret Clinical Strength Smooth Sensitive Hypoallergenic Unscented Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20150115 20180704 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-011_404368ce-15e1-05cb-e054-00144ff8d46c 69423-011 HUMAN OTC DRUG Gillette Clinical Advanced Fresh Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20150204 20180719 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-013_5322096d-7c41-711c-e054-00144ff88e88 69423-013 HUMAN OTC DRUG Secret Clinical Strength Clear Stress Response Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150209 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 20 g/100g N 20181231 69423-016_42ec722e-9827-2ec4-e054-00144ff88e88 69423-016 HUMAN OTC DRUG Secret Clinical Strength Clear Olay Beauty Skin Conditioners Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150121 20180903 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 20 g/100g N 20181231 69423-017_532f6d94-f70e-67bb-e054-00144ff88e88 69423-017 HUMAN OTC DRUG Secret Outlast Xtend Technology Clear Completely Clean Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150302 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 17 g/100g N 20181231 69423-018_42eea73b-ed0d-3cc0-e054-00144ff8d46c 69423-018 HUMAN OTC DRUG Secret Paris Romantic Rose Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150113 20181002 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-019_42eef404-1d17-5991-e054-00144ff8d46c 69423-019 HUMAN OTC DRUG Secret Scent Expressions Clear Coconut Splash Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150302 20181111 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-021_49c78b69-42f0-29c7-e054-00144ff8d46c 69423-021 HUMAN OTC DRUG Secret Outlast Xtend Technology Clear Sheer Energy Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150303 20180903 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 17 g/100g N 20181231 69423-022_77e34237-a423-4881-a8e2-f1563d7f12fa 69423-022 HUMAN OTC DRUG Secret Outlast Xtend Technology Clear Sensitive Clean Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150121 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 17 g/100g N 20181231 69423-023_42ef2ebd-163d-0ac7-e054-00144ff88e88 69423-023 HUMAN OTC DRUG Secret Scent Expressions Clear So Very Summerberry Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150303 20181003 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-024_42ef67ed-81b6-616d-e054-00144ff8d46c 69423-024 HUMAN OTC DRUG Secret Outlast Xtend Technology Clear Unscented Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20151216 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 17 g/100g N 20181231 69423-026_42af74f7-64c8-1574-e054-00144ff8d46c 69423-026 HUMAN OTC DRUG Secret Scent Expressions Clear Ooh La La Lavender Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150307 20181006 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-027_f51a1e17-fce5-4ef4-9086-093c873212a0 69423-027 HUMAN OTC DRUG Secret Outlast Xtend Technology Clear Sport Fresh Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150312 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 17 g/100g N 20181231 69423-028_42efe9cf-1002-0fba-e054-00144ff8d46c 69423-028 HUMAN OTC DRUG Secret Australia Eucalyptus Blossoms Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150213 20181202 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-030_42efe3dd-7f74-395c-e054-00144ff88e88 69423-030 HUMAN OTC DRUG Secret Hawaii Citrus Breeze Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150302 20180926 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-031_ff7de93c-cc03-43a2-9cd8-a9b5dc2f2c5a 69423-031 HUMAN OTC DRUG Secret Scent Expressions Truth or Pear Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150318 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-032_42efd16a-d040-0a64-e054-00144ff8d46c 69423-032 HUMAN OTC DRUG Secret Pasion de Tango Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150305 20181011 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-033_498985fe-cb46-0a5b-e054-00144ff8d46c 69423-033 HUMAN OTC DRUG Secret Scent Expressions Sunny Citrus Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150207 20180821 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-034_49c7878e-f66c-29bb-e054-00144ff8d46c 69423-034 HUMAN OTC DRUG Secret Scent Expressions Cabana Cool Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150121 20190102 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-035_42f055e7-b9b2-488f-e054-00144ff88e88 69423-035 HUMAN OTC DRUG Secret Bora Bora Fresh Orchid Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20150208 20180918 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-037_ec6ec343-bf21-4aac-b6ce-900f4f4b6f68 69423-037 HUMAN OTC DRUG Secret Outlast Invisible Fresh Lotus Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20150109 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 69423-041_44a8d6a2-b62c-4504-e054-00144ff88e88 69423-041 HUMAN OTC DRUG Secret Scent Expressions Invisible Coconut Splash Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20150202 20181208 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-042_1fe509e6-442b-4dfa-b5c0-451a8060b629 69423-042 HUMAN OTC DRUG Head and Shoulders Complete Scalp Care 2in1 Pyrithione Zinc SHAMPOO TOPICAL 20160112 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-044_6011ff82-bb2a-7940-e053-2991aa0aecf2 69423-044 HUMAN OTC DRUG Secret Invisible Tropical Orchid Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20150615 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 69423-047_d53ea772-88c8-4f0a-8d02-9d9d41ba97b8 69423-047 HUMAN OTC DRUG The Art of Shaving Daily Sunscreen Broad Spectrum SPF 15 Octinoxate, Avobenzone, and Octocrylene LOTION TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 Procter and Gamble Manufacturing Company OCTINOXATE; AVOBENZONE; OCTOCRYLENE 7.5; 3; 2.8 g/100mL; g/100mL; g/100mL N 20181231 69423-049_43a4938d-35a7-4913-e054-00144ff8d46c 69423-049 HUMAN OTC DRUG Olay Regenerist Regenerating Moisturizer Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 69423-050_604ebd3e-e464-510f-e053-2a91aa0ae22b 69423-050 HUMAN OTC DRUG Olay Regenerist Micro Sculpting Moisturizer Broad Spectrum SPF 30 Avobenzone and Octinoxate CREAM TOPICAL 20150813 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; OCTINOXATE 3; 7.5 mg/100mL; mg/100mL N 20181231 69423-051_5c6165a8-9599-cc9c-e053-2991aa0a51e2 69423-051 HUMAN OTC DRUG Olay Complete All Day Moisturizer Normal Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20161110 20190803 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69423-052_5c619560-fe58-117c-e053-2991aa0a6eb5 69423-052 HUMAN OTC DRUG Olay Complete All Day Moisture Broad Spectrum SPF 15 Normal Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20160219 20190803 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100g; g/100g; g/100g; g/100g N 20181231 69423-053_3a1162e6-53b6-46ba-8b91-a16ea43a1cb4 69423-053 HUMAN OTC DRUG Safeguard Antibacterial Hand Chloroxylenol LIQUID TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part333E Procter & Gamble Manufacturing Company CHLOROXYLENOL .5 mg/100mL N 20181231 69423-054_4277f3b2-c3f9-521b-e054-00144ff88e88 69423-054 HUMAN OTC DRUG Old Spice Sweat Defense Lasting Legend Extra Strong Anti-perspirant Deodorant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20151117 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g N 20181231 69423-055_597bea2e-f7eb-7f46-e053-2991aa0a6d4d 69423-055 HUMAN OTC DRUG Old Spice Sweat Defense Pure Sport Plus Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20151030 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g N 20181231 69423-056_4277f7b2-05d0-55af-e054-00144ff88e88 69423-056 HUMAN OTC DRUG Old Spice Sweat Defense Fresher Fiji Extra Strong Anti-perspirant Deodorant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20151124 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g N 20181231 69423-057_604eb917-30a4-b80c-e053-2991aa0aa2a6 69423-057 HUMAN OTC DRUG Old Spice Sweat Defense Extra Fresh Extra Strong Anti-perspirant Deodorant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20151117 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g N 20181231 69423-058_540aabe2-78e8-408e-e054-00144ff8d46c 69423-058 HUMAN OTC DRUG Old Spice Sweat Defense Stronger Swagger Extra Strong Anti-perspirant Deodorant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20151117 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g N 20181231 69423-059_604f1a69-870e-3ef1-e053-2991aa0a73cc 69423-059 HUMAN OTC DRUG Old Spice Odor Blocker Lasting Legend Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151102 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-060_42781411-72ce-1292-e054-00144ff8d46c 69423-060 HUMAN OTC DRUG Old Spice Odor Blocker Pure Sport Plus Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151102 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-061_540f10d3-f79d-17af-e054-00144ff88e88 69423-061 HUMAN OTC DRUG Old Spice Odor Blocker Stronger Swagger Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151102 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-062_a1a22d1e-19d8-443c-aeef-605d44ffafdd 69423-062 HUMAN OTC DRUG Old Spice Odor Blocker Tougher Timber Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151102 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-063_28120b5b-d332-4523-8525-c655268ef546 69423-063 HUMAN OTC DRUG Old Spice Odor Blocker Extra Fresh Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151102 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-064_60a02b87-1edf-0782-e053-2991aa0a8e21 69423-064 HUMAN OTC DRUG Old Spice Desperado Anti-perspirant and Deodorant Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20151130 20190115 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g N 20181231 69423-065_5cf4fd0a-c874-4c47-b4ec-3dd0538ea22e 69423-065 HUMAN OTC DRUG Secret Outlast Xtend Invisible Clean Lavender Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151121 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-067_431725d8-1552-1544-e054-00144ff8d46c 69423-067 HUMAN OTC DRUG Secret Outlast Xtend Invisible Sensitive Clean Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20160314 20180316 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-068_4ab1354e-3999-4f55-e054-00144ff88e88 69423-068 HUMAN OTC DRUG Secret Clinical Strength Invisible Ooh La La Lavender Scent Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151105 20190203 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 69423-069_532fbbec-35ae-6cca-e054-00144ff88e88 69423-069 HUMAN OTC DRUG Secret Clinical Strength Invisible Completely Clean Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151102 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 69423-070_4d61d64d-f6e7-6a32-e054-00144ff8d46c 69423-070 HUMAN OTC DRUG Secret Clinical Strength Invisible Protection Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151116 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 69423-071_4302424b-fcd5-1357-e054-00144ff8d46c 69423-071 HUMAN OTC DRUG Secret Clinical Strength Invisible with Olay Beauty Skin Conditioners Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151117 20180923 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 69423-072_1b4729e1-8ff7-4f14-b535-638486e61a9b 69423-072 HUMAN OTC DRUG Secret Clinical Strength Invisible Sensitive Hypoallergenic Unscented Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151117 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 69423-073_562da96d-ffc8-42da-abf7-979818699e53 69423-073 HUMAN OTC DRUG Secret Clinical Strength Invisible Stress Response Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151117 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 69423-074_46f52320-04e1-4375-b1b0-5a17a24abb5a 69423-074 HUMAN OTC DRUG Secret Clinical Strength Invisible Waterproof Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151124 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 69423-075_a74feb92-ec7a-47f3-acfd-700b9215064e 69423-075 HUMAN OTC DRUG Secret Clinical Strength Clear Waterproof Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20151215 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 20 g/100g N 20181231 69423-076_43145b21-7638-0958-e054-00144ff8d46c 69423-076 HUMAN OTC DRUG Secret Invisible Capri Island Retreat Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151115 20181013 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-077_43147e54-eb60-6930-e054-00144ff88e88 69423-077 HUMAN OTC DRUG Secret Capri Island Retreat Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20160110 20181007 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-079_4989cd42-68af-1165-e054-00144ff8d46c 69423-079 HUMAN OTC DRUG Secret Scent Expressions Invisible Macaroon Delight Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151121 20180319 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-080_5c61d445-a1ac-252a-e053-2a91aa0af826 69423-080 HUMAN OTC DRUG Gillette Endurance Ultimate Fresh Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20151101 20190812 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-081_5f4ad720-344c-4094-e053-2991aa0a50f5 69423-081 HUMAN OTC DRUG Gillette Clinical Pressure Defense Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20160118 20190102 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 20 g/100g N 20181231 69423-082_53306eb7-f989-0797-e054-00144ff8d46c 69423-082 HUMAN OTC DRUG Secret Outlast Xtend Technology Invisible Protecting Powder Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151110 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-083_93339fdd-f2fa-425b-b2fc-32607424ac71 69423-083 HUMAN OTC DRUG Secret Outlast Xtend Technology Invisible Sport Fresh Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151120 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-084_a1ad5bc7-6aac-4f4c-af4e-8e7d485cd42b 69423-084 HUMAN OTC DRUG Secret Outlast Xtend Technology Invisible Unscented Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151102 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-085_5330a5c5-c8c9-1541-e054-00144ff88e88 69423-085 HUMAN OTC DRUG Secret Outlast Xtend Technology Invisible Completely Clean Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151110 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-086_706e7029-bed4-4807-b59c-b3255fa93cde 69423-086 HUMAN OTC DRUG Secret Outlast Xtend Invisible Active Fresh Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20151102 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-087_5330a5c5-c8db-1541-e054-00144ff88e88 69423-087 HUMAN OTC DRUG Secret Outlast Xtend Technology Clear Protecting Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20151112 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 17 g/100g N 20181231 69423-088_6018be17-d591-77ee-e053-2991aa0a0e25 69423-088 HUMAN OTC DRUG Olay Age Defying Classic Protective Renewal Broad Spectrum SPF 15 Octinoxate and Zinc Oxide LOTION TOPICAL 20160109 20190705 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100mL; g/100mL N 20181231 69423-089_756844f7-1d6c-4345-a500-a12127c5d689 69423-089 HUMAN OTC DRUG Olay Age Defying Anti-Wrinkle Day Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20160119 OTC MONOGRAPH NOT FINAL part352 Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69423-090_5d572177-e6b5-d595-e053-2991aa0a6a8b 69423-090 HUMAN OTC DRUG Olay Complete All Day Moisturizer Sensitive Broad Spectrum SPF 15 Octinoxate and Zinc Oxide LOTION TOPICAL 20160307 20190921 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100mL; g/100mL N 20181231 69423-091_5c4eb0be-8de0-1c3b-e053-2a91aa0aa5c3 69423-091 HUMAN OTC DRUG Head and Shoulders Nourishing Hair and Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20160112 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-092_5df8ea40-e2ab-dff6-e053-2991aa0aa09a 69423-092 HUMAN OTC DRUG Head and Shoulders Nourishing Hair and Scalp Care 2in1 Pyrithione Zinc SHAMPOO TOPICAL 20160119 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-093_5a46243e-cfea-9a5c-e053-2a91aa0ab365 69423-093 HUMAN OTC DRUG Head and Shoulders Nourishing Hair and Scalp Care Conditioner Pyrithione Zinc LOTION TOPICAL 20160128 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 69423-094_5a3f7c80-1b61-0d48-e053-2991aa0a1027 69423-094 HUMAN OTC DRUG Head and Shoulders Instant Fresh Pyrithione Zinc SHAMPOO TOPICAL 20160110 20190621 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-095_6054f1c3-ba70-7c35-e053-2a91aa0aecee 69423-095 HUMAN OTC DRUG Head and Shoulders Instant Fresh 2in1 Pyrithione Zinc SHAMPOO TOPICAL 20160103 20191113 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-096_60a4aa33-ca06-133e-e053-2991aa0ad74d 69423-096 HUMAN OTC DRUG Head and Shoulders Dual Sachets Instant Relief Pyrithione Zinc KIT 20160110 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company N 20181231 69423-097_df790dd6-e02d-4a95-b0f8-4df70bc4cd1b 69423-097 HUMAN OTC DRUG Secret Outlast Xtend Technology Clear Active Fresh Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20151112 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 17 g/100g N 20181231 69423-098_4316413c-d23c-6ac2-e054-00144ff8d46c 69423-098 HUMAN OTC DRUG Secret Outlast Xtend Technology Clear Clean Lavender Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20160612 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 17 g/100g N 20181231 69423-099_4adaeed6-cac5-3467-e054-00144ff8d46c 69423-099 HUMAN OTC DRUG Head and Shoulders Old Spice Swagger Pyrithione Zinc SHAMPOO TOPICAL 20160608 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-100_597ba527-f9f5-0804-e053-2a91aa0a5c3f 69423-100 HUMAN OTC DRUG Head and Shoulders Old Spice Swagger 2in1 Pyrithione Zinc SHAMPOO TOPICAL 20160608 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-101_6054ff44-b298-8581-e053-2991aa0a9e63 69423-101 HUMAN OTC DRUG Head and Shoulders Men 2in1 Old Spice Pure Sport Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20160926 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-102_414a401a-3cae-4a7b-e054-00144ff88e88 69423-102 HUMAN OTC DRUG Head and Shoulders MEN Old Spice Pure Sport Pyrithione Zinc SHAMPOO TOPICAL 20161110 OTC MONOGRAPH FINAL part358H Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-103_6063eb3d-729f-d31a-e053-2a91aa0a9696 69423-103 HUMAN OTC DRUG Head and Shoulders Conditioner Smooth and Silky Pyrithione Zinc LOTION TOPICAL 20161110 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 69423-112_60642938-5fbd-1daa-e053-2a91aa0a0cfb 69423-112 HUMAN OTC DRUG Gillette Clinical Advanced Ultimate Fresh Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20160801 20191129 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-113_6063dcca-a00d-c10d-e053-2a91aa0a8b99 69423-113 HUMAN OTC DRUG Gillette Clinical Advanced Sport Triumph Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20160801 20191122 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-114_53f825e8-1e7b-6e64-e054-00144ff8d46c 69423-114 HUMAN OTC DRUG Secret Cool Waterlily Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20161105 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-115_4053d10b-4b04-291b-e054-00144ff88e88 69423-115 HUMAN OTC DRUG Secret Cool Waterlily Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20161105 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-116_406762c2-785d-5302-e054-00144ff88e88 69423-116 HUMAN OTC DRUG Secret Chill Ocean Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20161105 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-117_53f8b35c-5311-55f2-e054-00144ff88e88 69423-117 HUMAN OTC DRUG Secret Boho Berry Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20161108 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 69423-118_53f8b35c-5327-55f2-e054-00144ff88e88 69423-118 HUMAN OTC DRUG Secret Cool Waterlily Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20161108 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-119_53f8d06f-fd97-61df-e054-00144ff88e88 69423-119 HUMAN OTC DRUG Secret Classic Cocoa Butter Scent Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20161108 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-120_53f8d06f-fda8-61df-e054-00144ff88e88 69423-120 HUMAN OTC DRUG Secret Classic Cocoa Butter Scent Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20161108 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 69423-121_407ada63-6e6d-6e33-e054-00144ff8d46c 69423-121 HUMAN OTC DRUG Secret Va Va Vanilla Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20161105 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-122_407b972b-5773-226a-e054-00144ff8d46c 69423-122 HUMAN OTC DRUG Old Spice Odor Blocker Steel Courage Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20161213 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-123_407d40e8-eaae-084e-e054-00144ff8d46c 69423-123 HUMAN OTC DRUG Old Spice Odor Blocker Bolder Bearglove Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20161213 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-124_407d40e8-eace-084e-e054-00144ff8d46c 69423-124 HUMAN OTC DRUG Old Spice Sweat Defense Steel Courage Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20161203 OTC MONOGRAPH FINAL part350 Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g N 20181231 69423-125_40bd3462-47b3-5f95-e054-00144ff88e88 69423-125 HUMAN OTC DRUG Olay Regenerist Regenerating Advanced Anti-Aging Moisturize Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.7; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69423-126_53fa0457-7d5b-51aa-e054-00144ff8d46c 69423-126 HUMAN OTC DRUG Secret Pasion de Tango Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20161108 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-127_53fa0457-7d6a-51aa-e054-00144ff8d46c 69423-127 HUMAN OTC DRUG Secret Clinical Strength Soft Clean Lavender Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20161108 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-128_40e2f725-1bdf-4652-e054-00144ff88e88 69423-128 HUMAN OTC DRUG Secret Clinical Strength Soft Protection Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20161108 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-129_5d578e5e-ad80-2ebe-e053-2a91aa0aa0e3 69423-129 HUMAN OTC DRUG Secret Clinical Strength Soft Sport Fresh Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20161108 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-130_40e377ec-feba-0963-e054-00144ff8d46c 69423-130 HUMAN OTC DRUG Secret Clinical Strength Soft Waterproof Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20161108 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-131_60630127-19bc-1dd9-e053-2a91aa0a837c 69423-131 HUMAN OTC DRUG Secret Luxe Lavender Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20161108 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-132_6064b662-4dd8-39f1-e053-2a91aa0a4d59 69423-132 HUMAN OTC DRUG Secret Luxe Lavender Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20160928 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 69423-133_40fa0c3f-94e1-4cdb-e054-00144ff8d46c 69423-133 HUMAN OTC DRUG Secret Paris Rose Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20160928 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-134_40f511a7-a630-2de6-e054-00144ff8d46c 69423-134 HUMAN OTC DRUG Secret Hawaii Citrus Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20160928 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-135_40f8cba4-3c34-0281-e054-00144ff8d46c 69423-135 HUMAN OTC DRUG Secret Hawaii Citrus Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20160928 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-136_40e3b957-d851-5a66-e054-00144ff88e88 69423-136 HUMAN OTC DRUG Old Spice Krakengard Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20161213 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 69423-137_40e467df-9135-38ab-e054-00144ff8d46c 69423-137 HUMAN OTC DRUG Secret Clinical Strength Soft Stress Response Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20161108 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-138_6064d709-f6c7-38a4-e053-2991aa0a3482 69423-138 HUMAN OTC DRUG Secret Clinical Strength Soft Light and Fresh Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20161108 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-139_40fa9d77-b822-19cb-e054-00144ff88e88 69423-139 HUMAN OTC DRUG Secret Wild Sugar Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20160928 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-140_40fa20a3-4d3b-50ce-e054-00144ff8d46c 69423-140 HUMAN OTC DRUG Secret Fresh Orchid Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20160928 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-141_410ae37e-6c98-65f0-e054-00144ff88e88 69423-141 HUMAN OTC DRUG Secret Va Va Vanilla Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20160928 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 69423-142_410ae37e-6cab-65f0-e054-00144ff88e88 69423-142 HUMAN OTC DRUG Secret Chill Ocean Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20160928 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 69423-143_410ae37e-6c82-65f0-e054-00144ff88e88 69423-143 HUMAN OTC DRUG Secret Pasion de Tango Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20160928 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 69423-144_4109634d-cdcd-511b-e054-00144ff8d46c 69423-144 HUMAN OTC DRUG Secret Fresh Orchid Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20160928 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-145_4109634d-cdc4-511b-e054-00144ff8d46c 69423-145 HUMAN OTC DRUG Secret Paris Rose Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20160928 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-146_410a7ce3-e903-57ab-e054-00144ff88e88 69423-146 HUMAN OTC DRUG Secret Wild Sugar Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20160928 OTC MONOGRAPH FINAL part350 Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-147_5e08c47a-e893-310e-e053-2a91aa0a99c8 69423-147 HUMAN OTC DRUG Head and Shoulders Repair and Protect Pyrithione Zinc SHAMPOO TOPICAL 20160608 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-148_5e855354-4f8b-3d21-e053-2991aa0a20d9 69423-148 HUMAN OTC DRUG Head and Shoulders Repair and Protect 2in1 Pyrithione Zinc SHAMPOO TOPICAL 20161115 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-149_598f23f9-ac05-2ced-e053-2a91aa0aec20 69423-149 HUMAN OTC DRUG Head and Shoulders Repair and Protect Hair and Scalp Conditioner Pyrithione Zinc LOTION TOPICAL 20161115 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 69423-150_5e1ef701-6dbd-453c-e053-2a91aa0a2b64 69423-150 HUMAN OTC DRUG Head and Shoulders Volume Boost Pyrithione Zinc SHAMPOO TOPICAL 20161121 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20191231 69423-151_597dc066-2083-f41a-e053-2991aa0a6873 69423-151 HUMAN OTC DRUG Head and ShouldersVolume Boost Hair and Scalp Conditioner Pyrithione Zinc LOTION TOPICAL 20161121 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 69423-152_41963d1c-8ddb-08ef-e054-00144ff8d46c 69423-152 HUMAN OTC DRUG Head and Shoulders Clinical Solutions Leave-On Dandruff Treatment Pyrithione Zinc LIQUID TOPICAL 20161117 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .1 g/100mL N 20181231 69423-153_4197325c-8025-36d6-e054-00144ff8d46c 69423-153 HUMAN OTC DRUG Head and Shoulders Repair and Protect Pyrithione Zinc SHAMPOO TOPICAL 20161117 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-154_426397fa-82f6-382b-e054-00144ff8d46c 69423-154 HUMAN OTC DRUG Head and Shoulders Itch Selenium Sulfide SHAMPOO TOPICAL 20161117 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company SELENIUM SULFIDE 1 g/100mL N 20181231 69423-155_5e1d12d3-cb33-5420-e053-2a91aa0ac0ca 69423-155 HUMAN OTC DRUG Head and Shoulders Sensitive Scalp Care Pyrithione Zinc SHAMPOO TOPICAL 20161121 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20191231 69423-156_5e1c4e31-9c37-1113-e053-2a91aa0ae173 69423-156 HUMAN OTC DRUG Head and Shoulders Sensitive Scalp Care 2in1 Pyrithione Zinc SHAMPOO TOPICAL 20161121 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20191231 69423-157_41ff7329-e504-1b54-e054-00144ff8d46c 69423-157 HUMAN OTC DRUG Gillette Clinical Cool Wave Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20160202 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 20 g/100g N 20181231 69423-158_425dad0b-eed1-17c3-e054-00144ff8d46c 69423-158 HUMAN OTC DRUG Gillette Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20160801 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g N 20181231 69423-159_60a123b9-a3c2-64e1-e053-2a91aa0ad03d 69423-159 HUMAN OTC DRUG Head and Shoulders Instant Hydration Hair and Scalp Conditioner Pyrithione Zinc LOTION TOPICAL 20161110 20181228 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 69423-160_4262024a-7d82-5de0-e054-00144ff8d46c 69423-160 HUMAN OTC DRUG Head and Shoulders Dry Scalp Care Hair and Scalp Conditioner Pyrithione Zinc LOTION TOPICAL 20161110 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 69423-161_42631ef5-f2aa-25d2-e054-00144ff8d46c 69423-161 HUMAN OTC DRUG Head and Shoulders Itchy Scalp Care Hair and Scalp Conditioner Pyrithione Zinc LOTION TOPICAL 20161110 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 69423-162_60a11c31-af27-599e-e053-2a91aa0a3484 69423-162 HUMAN OTC DRUG Secret Invisible Powder Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20160711 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 69423-163_42771678-4dce-5613-e054-00144ff8d46c 69423-163 HUMAN OTC DRUG Old Spice Sweat Defense Bolder Bearglove Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20161011 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g N 20181231 69423-164_4547b3ef-b05d-5b7d-e054-00144ff88e88 69423-164 HUMAN OTC DRUG Secret Invisible Shower Fresh Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20160630 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 69423-165_60a4fde2-a2ad-c22b-e053-2a91aa0adc61 69423-165 HUMAN OTC DRUG Secret Invisible Spring Breeze Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20160604 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 19 g/100g N 20181231 69423-166_433c6646-7678-63ae-e054-00144ff8d46c 69423-166 HUMAN OTC DRUG Secret Invisible Sheer Clean Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20160801 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 69423-167_433ca7e5-9a04-6ef0-e054-00144ff8d46c 69423-167 HUMAN OTC DRUG Secret Invisible Unscented Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20160710 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 69423-168_43a22af4-1338-640e-e054-00144ff88e88 69423-168 HUMAN OTC DRUG Head and Shoulders Hair and Scalp Conditioner Instant Relief Pyrithione Zinc LOTION TOPICAL 20161001 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 69423-169_54c46aae-9b99-3334-e054-00144ff8d46c 69423-169 HUMAN OTC DRUG Olay Luminous Brightening and Protecting with Sunscreen Advanced Tone Perfecting Moisturize Broad Spectrum SPF 15 Fragrance-Free Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20161013 20190228 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69423-170_441981f3-7192-4c9e-e054-00144ff8d46c 69423-170 HUMAN OTC DRUG Olay Regenerist Day and Night Trial Pack Avobenzone, and Octinoxate KIT TOPICAL 20161213 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company N 20181231 69423-171_60a51d4b-5e89-d3e6-e053-2991aa0a73ce 69423-171 HUMAN OTC DRUG Head and Shoulders Hair and Scalp Conditioner Classic Clean Pyrithione Zinc LOTION TOPICAL 20161001 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 69423-172_4534c7a7-bc4c-3851-e054-00144ff88e88 69423-172 HUMAN OTC DRUG Head and Shoulders Hair and Scalp Conditioner Green Apple Pyrithione Zinc LOTION TOPICAL 20161001 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 69423-173_454b76fe-3698-6266-e054-00144ff88e88 69423-173 HUMAN OTC DRUG Olay Total Effects Top Sellers Trial Pack Avobenzone, Homosalate, Octisalate, and Octocrylene KIT TOPICAL 20161213 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company N 20181231 69423-174_46dee2e1-d4f2-09e7-e054-00144ff88e88 69423-174 HUMAN OTC DRUG Olay Clearly Clean Acne Treament Scrub Salicylic Acid LIQUID TOPICAL 20170103 OTC MONOGRAPH FINAL part333D The Procter & Gamble Manufacturing Company SALICYLIC ACID 2 g/100mL N 20181231 69423-175_4819fc29-0caf-4be7-e054-00144ff8d46c 69423-175 HUMAN OTC DRUG Secret Clinical Strength Soft Sensitive Unscented Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20161108 OTC MONOGRAPH FINAL part350 The Procter and Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-176_60a569b5-9f82-4165-e053-2a91aa0a6809 69423-176 HUMAN OTC DRUG Secret Clinical Strength Invisible Clean Lavender Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20170210 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100g N 20181231 69423-177_60a56cf5-6f13-4530-e053-2a91aa0afa71 69423-177 HUMAN OTC DRUG Secret Clinical Strength Clear Clean Lavender Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20170206 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 20 g/100g N 20181231 69423-178_4d857861-3924-2899-e054-00144ff8d46c 69423-178 HUMAN OTC DRUG Pantene Pro-V Hydra Scalp Care Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20170605 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-179_5901e3a0-7dfa-f51a-e053-2a91aa0a90c3 69423-179 HUMAN OTC DRUG Pantene Pro-V Hydra Scalp Care 2in1 Pyrithione Zinc SHAMPOO TOPICAL 20170605 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-180_58fee297-3b01-b7dd-e053-2a91aa0afeb9 69423-180 HUMAN OTC DRUG Olay Age Defying Advanced with Hyaluronic Acid Hydrating MoisturizerProtective Renewal Broad Spectrum SPF 15 Octinoxate and Zinc Oxide LOTION TOPICAL 20170627 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100mL; g/100mL N 20181231 69423-181_5902cc80-0ef9-95b8-e053-2991aa0a4862 69423-181 HUMAN OTC DRUG Secret Freshies On-The-Go Invisible Luxe Lavender Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20170927 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 69423-182_5902cc80-0ed7-95b8-e053-2991aa0a4862 69423-182 HUMAN OTC DRUG Secret Freshies On-The-Go Invisible Cool Waterlily Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20170927 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 69423-183_60a596a3-2c5e-1686-e053-2991aa0ac473 69423-183 HUMAN OTC DRUG Secret Invisible Luxe Lavender Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20170711 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-184_56cd4bdb-efbf-48ce-e054-00144ff8d46c 69423-184 HUMAN OTC DRUG Secret Invisible Glam Grapefruit Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20170711 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-185_56cd7239-b1e5-4f55-e054-00144ff8d46c 69423-185 HUMAN OTC DRUG Secret Invisible Boho Berry Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20170711 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-186_56cdafcd-3020-5cbb-e054-00144ff8d46c 69423-186 HUMAN OTC DRUG Secret Invisible Cool Waterlily Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20170711 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-187_5902fd12-cf2c-54be-e053-2991aa0a50fd 69423-187 HUMAN OTC DRUG Old Spice Invisible Bearglove Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20170519 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-188_4faa1955-cc29-438f-e054-00144ff8d46c 69423-188 HUMAN OTC DRUG Old Spice Invisible Pure Sport Aluminum chlorohydrate SPRAY TOPICAL 20170519 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-189_4faa1955-cc22-438f-e054-00144ff8d46c 69423-189 HUMAN OTC DRUG Old Spice Invisible Swagger Aluminum chlorohydrate SPRAY TOPICAL 20170519 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-190_4faa336d-ad8e-4982-e054-00144ff8d46c 69423-190 HUMAN OTC DRUG Gillette Invisible Cool Wave Aluminum chlorohydrate SPRAY TOPICAL 20170519 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-191_4faa8c36-6efc-391f-e054-00144ff88e88 69423-191 HUMAN OTC DRUG Gillette Invisible Power Rush Aluminum chlorohydrate SPRAY TOPICAL 20170519 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-192_5049577c-dc24-02e0-e054-00144ff88e88 69423-192 HUMAN OTC DRUG Pantene Pro-V Hydra Scalp Care Conditioner Pyrithione Zinc LOTION TOPICAL 20170605 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 69423-193_58ec7226-fcff-5aff-e053-2991aa0a365b 69423-193 HUMAN OTC DRUG Head and Shoulders Men 2in1 Old Spice Fiji Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20170911 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-194_59052236-6283-ea2d-e053-2991aa0a2fdb 69423-194 HUMAN OTC DRUG Olay Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15 Octinoxate and Zinc Oxide LOTION TOPICAL 20170911 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100mL; g/100mL N 20181231 69423-195_5918103a-5ba7-45b8-e053-2991aa0a246f 69423-195 HUMAN OTC DRUG Olay Complete UV 365 Daily Moisturizer Normal Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20170911 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69423-196_5e33fa87-9676-4bf9-e053-2a91aa0a77d3 69423-196 HUMAN OTC DRUG Head and Shoulders Tea Tree 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20171201 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-197_58ecdd38-1f24-ee32-e053-2991aa0afe81 69423-197 HUMAN OTC DRUG Head and Shoulders Deep Moisture Hair and Scalp Conditioner Pyrithione Zinc LOTION TOPICAL 20170911 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC .5 g/100mL N 20181231 69423-198_598f01a6-e692-c3e6-e053-2991aa0adc43 69423-198 HUMAN OTC DRUG Head and Shoulders Clinical Solutions 2in1 Dandruff selenium sulfide SHAMPOO TOPICAL 20171001 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company SELENIUM SULFIDE 1 g/100mL N 20181231 69423-199_598f293d-e837-8eef-e053-2a91aa0ac6dd 69423-199 HUMAN OTC DRUG Head and Shoulders Clinical Solutions 2in1 Itch Selenium Sulfide SHAMPOO TOPICAL 20171001 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company SELENIUM SULFIDE 1 g/100mL N 20181231 69423-200_5f49e65c-dc7c-35f0-e053-2991aa0ae99f 69423-200 HUMAN OTC DRUG Gillette Endurance Wild Rain Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20170620 20190826 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-201_60b32f5b-416b-c148-e053-2a91aa0af609 69423-201 HUMAN OTC DRUG Secret Active Fresh Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20170927 20190327 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19.2 g/100g N 20181231 69423-202_60b347d4-0b3c-8fcd-e053-2a91aa0a40ec 69423-202 HUMAN OTC DRUG Secret Active Cool Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20170927 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-203_60b36722-0753-fbf7-e053-2a91aa0a5737 69423-203 HUMAN OTC DRUG Secret Active Sport Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20170927 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-204_60b3893a-20dc-1198-e053-2991aa0a8d93 69423-204 HUMAN OTC DRUG Secret Active Fresh Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20170927 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 17 g/100g N 20181231 69423-205_60b44016-afd3-8b30-e053-2a91aa0a626d 69423-205 HUMAN OTC DRUG Secret Active Cool Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20170927 20181010 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-206_60b3c5d5-b114-6e9a-e053-2a91aa0a5765 69423-206 HUMAN OTC DRUG Secret Active Sport Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20170927 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 17 g/100g N 20181231 69423-207_54102354-d9ee-0491-e054-00144ff8d46c 69423-207 HUMAN OTC DRUG Olay Luminous Brightening and Protecting with Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20170424 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 2.6; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69423-208_5742b898-243d-d799-e053-2a91aa0a969a 69423-208 HUMAN OTC DRUG Old Spice Palm Trees In A Box Fiji Aluminum zirconium trichlorohydrex Gly KIT TOPICAL 20160610 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company N 20181231 69423-212_588826d9-4f4c-def3-e053-2a91aa0a7d25 69423-212 HUMAN OTC DRUG Old Spice Daily Moisturizer with Sunscreen Broadspectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69423-213_58f0c224-5866-63b6-e053-2991aa0a7a22 69423-213 HUMAN OTC DRUG Old Spice Stronger Swagger 2in1 Anti Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20170911 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/mL N 20181231 69423-214_58f16a00-3e15-29de-e053-2991aa0a59a0 69423-214 HUMAN OTC DRUG Old Spice Pure Sport Plus 2in1 Anti-dandruff Pyrithione Zinc SHAMPOO TOPICAL 20170911 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-215_58fef974-d6d4-75db-e053-2991aa0a819d 69423-215 HUMAN OTC DRUG Old Spice Steel Courage 2in1 Anti Dandruff Pyrithione Zinc SHAMPOO TOPICAL 20170911 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/mL N 20181231 69423-216_592a70f8-8256-be59-e053-2a91aa0ab934 69423-216 HUMAN OTC DRUG Olay Complete Normal UV365 Daily Moisture with sunscreen Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20170911 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100g; g/100g; g/100g; g/100g N 20181231 69423-217_592be7ba-9fd7-5c2f-e053-2991aa0ad6df 69423-217 HUMAN OTC DRUG Olay Complete UV 365 Daily Moisturizer Combination Oily Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20170911 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 4; 4.5; 2.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69423-218_5ae29f76-b449-db83-e053-2a91aa0a5bdc 69423-218 HUMAN OTC DRUG Olay Regenerist Whip Active Moisturizer Broad Spectrum SPF 25 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20171128 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 8; 4; 5 g/100g; g/100g; g/100g; g/100g N 20181231 69423-219_5ae245fe-fe8b-7a84-e053-2a91aa0aa98f 69423-219 HUMAN OTC DRUG Olay Total Effects Whip Active Moisturizer Broad Spectrum SPF 25 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20171128 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 8; 4; 5 g/100g; g/100g; g/100g; g/100g N 20181231 69423-220_5b1ec22f-be1c-c5c9-e053-2a91aa0a535e 69423-220 HUMAN OTC DRUG Secret Active Sport Invisible Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20171027 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-221_5b224f63-09c1-4a80-e053-2991aa0aab25 69423-221 HUMAN OTC DRUG Secret Active Cool Invisible Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20171027 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-222_5b23c1b3-4f88-c116-e053-2991aa0a3c78 69423-222 HUMAN OTC DRUG Gillette Arctic Ice Invisible Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20171027 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-223_5b22aa29-482d-ff0b-e053-2a91aa0a4320 69423-223 HUMAN OTC DRUG Gillette Undefeated Invisible Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20171027 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-224_5b23260d-9264-26c0-e053-2a91aa0a1a85 69423-224 HUMAN OTC DRUG Old Spice Wolfthorn Invisible Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20171027 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-225_5b2396f2-5352-aeec-e053-2991aa0a21f3 69423-225 HUMAN OTC DRUG Old Spice Fiji Invisible Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20171027 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-226_5b231b79-b826-1575-e053-2a91aa0a1b87 69423-226 HUMAN OTC DRUG Secret Active Fresh Invisible Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20171027 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-227_5b23a410-18b9-b8d7-e053-2a91aa0ae330 69423-227 HUMAN OTC DRUG Old Spice Captain Invisible Aluminum chlorohydrate AEROSOL, SPRAY TOPICAL 20171027 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM CHLOROHYDRATE 24.1 g/100g N 20181231 69423-231_5b33513c-41a0-6736-e053-2a91aa0a1c53 69423-231 HUMAN OTC DRUG Olay Luminous Whip Active Moisturizer Broad Spectrum SPF 25 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20171128 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 8; 4; 5 g/100g; g/100g; g/100g; g/100g N 20181231 69423-232_5b224f63-0966-4a80-e053-2991aa0aab25 69423-232 HUMAN OTC DRUG Secret Freshies On-The-Go Invisible Chill Ocean Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20171011 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 69423-233_5b22aa29-4822-ff0b-e053-2a91aa0a4320 69423-233 HUMAN OTC DRUG Secret Freshies On-The-Go Invisible Paris Rose Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20171011 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 18 g/100g N 20181231 69423-234_5b3687c1-df09-891e-e053-2991aa0a91e5 69423-234 HUMAN OTC DRUG Old Spice Red Collection Nomad Scent of Adventure Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20171219 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g N 20181231 69423-235_5b3736fe-5f23-9d5b-e053-2991aa0a206e 69423-235 HUMAN OTC DRUG Old Spice Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20171219 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g N 20181231 69423-236_5b37a0b5-851f-fafd-e053-2a91aa0a8e8d 69423-236 HUMAN OTC DRUG Old Spice Red Collection Captain Scent of Command Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20171219 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g N 20181231 69423-237_5bd669f6-eb7b-d68c-e053-2a91aa0a352c 69423-237 HUMAN OTC DRUG Old Spice Red Collection Ambassador Scent of Excellence Aluminum Zirconium Trichlorohydrex Gly STICK TOPICAL 20171219 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 17 g/100g N 20181231 69423-238_5bc3c224-1589-0f01-e053-2991aa0adcf3 69423-238 HUMAN OTC DRUG Gillette Clear Arctic Ice Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20171001 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-239_5bc46f65-324b-7973-e053-2a91aa0ad6cf 69423-239 HUMAN OTC DRUG Gillette Clear Ocean Blast Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20171121 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-240_5bc57737-ce03-7f9b-e053-2a91aa0a887a 69423-240 HUMAN OTC DRUG Gillette Clear Cool Wave Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20170901 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-241_5bd73ad7-fba9-bc24-e053-2a91aa0a058d 69423-241 HUMAN OTC DRUG Gillette Clear Wild Rain Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20170901 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-242_5bd824f1-ac42-8ede-e053-2a91aa0adaaa 69423-242 HUMAN OTC DRUG Gillette Clear Sport Triumph Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20170901 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-243_5bea90f5-b404-3056-e053-2a91aa0a73de 69423-243 HUMAN OTC DRUG Gillette Clear Ultimate Fresh Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20170901 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-244_5d66ba66-c744-465d-e053-2991aa0a6995 69423-244 HUMAN OTC DRUG Gillette Clear Undefeated Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20170828 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-245_5d7ef4e8-f128-5392-e053-2a91aa0a4604 69423-245 HUMAN OTC DRUG Gillette Clinical Soft Sport Triumph Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20170807 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20191231 69423-246_5e208b85-7a44-57ec-e053-2991aa0a622c 69423-246 HUMAN OTC DRUG Head and Shoulders Volume Boost 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20171201 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-247_5e212948-68db-bdf2-e053-2991aa0a649f 69423-247 HUMAN OTC DRUG Head and Shoulders Deep Moisture pyrithione zinc SHAMPOO TOPICAL 20171201 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-248_5e21bdd3-ad64-0c10-e053-2a91aa0abdd5 69423-248 HUMAN OTC DRUG Head and Shoulders Deep Moisture 2in1 Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20171201 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-249_5e862383-e1c0-7677-e053-2a91aa0ac59e 69423-249 HUMAN OTC DRUG Head and Shoulders Tea Tree Pyrithione Zinc LOTION/SHAMPOO TOPICAL 20171201 OTC MONOGRAPH FINAL part358H The Procter & Gamble Manufacturing Company PYRITHIONE ZINC 1 g/100mL N 20181231 69423-250_5f1ff07e-5b72-4527-e053-2991aa0a492b 69423-250 HUMAN OTC DRUG Secret Vibrant Yuzu Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20171219 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-251_5f2198ee-7854-0be1-e053-2a91aa0af12c 69423-251 HUMAN OTC DRUG Secret Calm Birch Water Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20171219 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-252_5f2182fa-4396-09bb-e053-2a91aa0ae8b5 69423-252 HUMAN OTC DRUG Secret Vibrant Yuzu Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20171219 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-253_5f24721e-a936-276f-e053-2991aa0a19bb 69423-253 HUMAN OTC DRUG Secret Calm Birch Water Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20171219 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-254_5f341326-7b1a-ccad-e053-2991aa0a64be 69423-254 HUMAN OTC DRUG Secret Clinical Strength Clear Cooling Breeze Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20171219 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 20 g/100g N 20181231 69423-255_5f493eaa-615c-87d8-e053-2991aa0ac5c6 69423-255 HUMAN OTC DRUG Gillette Clear Power Rush Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20170930 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 16 g/100g N 20181231 69423-256_5f886fcb-062b-069b-e053-2991aa0a3eb1 69423-256 HUMAN OTC DRUG Gillette Clinical Soft Ultimate Fresh Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20170807 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69423-258_60a2f896-8304-30b8-e053-2a91aa0a60ba 69423-258 HUMAN OTC DRUG Olay Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 30 Sensitive Octinoxate, Octisalate, Octocrylene, and Zinc Oxide LOTION TOPICAL 20170621 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 7.5; 2.5; 2.5; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 69423-259_60183a47-fd03-052b-e053-2991aa0a1b5c 69423-259 HUMAN OTC DRUG Olay Age Defying Classic Daily Renewal Broad Spectrum SPF 15 Octinoxate and Zinc Oxide LOTION TOPICAL 20170811 OTC MONOGRAPH NOT FINAL part352 The Procter & Gamble Manufacturing Company OCTINOXATE; ZINC OXIDE 6; 3 g/100mL; g/100mL N 20181231 69423-260_60b2e3c3-51f0-55a6-e053-2a91aa0a9462 69423-260 HUMAN OTC DRUG Secret Active Fresh Invisible Aluminum Zirconium Tetrachlorohydrex Gly STICK TOPICAL 20171016 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 19 g/100g N 20181231 69423-261_60b42e02-905f-75eb-e053-2a91aa0a1155 69423-261 HUMAN OTC DRUG Secret Active Cool Clear Aluminum Zirconium Octachlorohydrex Gly GEL TOPICAL 20171016 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 17 g/100g N 20181231 69423-262_60b500eb-fc08-766e-e053-2a91aa0a8ca8 69423-262 HUMAN OTC DRUG Secret Clinical Strength Soft Cooling Breeze Aluminum Zirconium Trichlorohydrex Gly CREAM TOPICAL 20180109 OTC MONOGRAPH FINAL part350 The Procter & Gamble Manufacturing Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69424-010_e5c7c476-0a8c-4ee2-9868-9a40d9d30f57 69424-010 HUMAN OTC DRUG AC CLEAR TREATMENT MASK Witch Hazel PATCH TOPICAL 20150102 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-020_b1e97d6d-62e1-42a4-b705-b2fa89501eb3 69424-020 HUMAN OTC DRUG ANTI AGING TREATMENT MASK Witch Hazel PATCH TOPICAL 20150102 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-030_1bd959eb-e39b-4e4c-8be7-43bb63ec3c9c 69424-030 HUMAN OTC DRUG VITA BRIGHTENING RENEWAL MASK Witch Hazel PATCH TOPICAL 20150102 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-040_6f1607dc-51b2-4a56-8411-2915fea2fd52 69424-040 HUMAN OTC DRUG AQUARINGER TREATMENT MASK Witch Hazel PATCH TOPICAL 20150102 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 25 mg/25mL N 20181231 69424-050_cd184c3d-d188-47c3-b281-703b059adf75 69424-050 HUMAN OTC DRUG ALOE SOOTHING RENEWAL MASK Witch Hazel PATCH TOPICAL 20150102 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-060_1e0aecba-90fc-4cb9-9250-df0de301cfb4 69424-060 HUMAN OTC DRUG ILLUMINATING Treatment Mask Witch Hazel PATCH TOPICAL 20150102 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-070_435a1784-c068-4fef-bbf1-785d42636242 69424-070 HUMAN OTC DRUG COLLAGEN BOOSTING RENEWAL MASK Witch Hazel PATCH TOPICAL 20150102 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-080_40b8664e-0aff-4c87-abda-27247bf6b004 69424-080 HUMAN OTC DRUG TEATREE RELAXING RENEWAL MASK Witch Hazel PATCH TOPICAL 20150102 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-090_7b823d31-8da8-401f-aa40-e44544f49b3b 69424-090 HUMAN OTC DRUG LEADERS INSOLUTION COCONUT LIFTING RECOVERY MASK Witch Hazel PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 30 mg/30mL N 20181231 69424-100_d973cc0b-2451-4b10-88aa-0ae45af74318 69424-100 HUMAN OTC DRUG Leaders Insolution Coconut Mask with Broccoli Witch Hazel PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 30 mg/30mL N 20181231 69424-110_bc606086-56c3-4176-9714-e0b7ff2980f8 69424-110 HUMAN OTC DRUG Leaders Insolution Coconut Mask with Blueberry Witch Hazel PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-120_34a9f1ec-2e18-455f-a2e7-b858671c9e4f 69424-120 HUMAN OTC DRUG Leaders Insolution Coconut Mask with Orange Witch Hazel PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-130_066e7264-a173-4946-8f42-aa978ff48c70 69424-130 HUMAN OTC DRUG Leaders Insolution Coconut Mask with Tomato Witch Hazel PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-140_1f4311ec-6afb-4ec7-9845-19d321dd7abf 69424-140 HUMAN OTC DRUG Leaders Insolution Coconut Moisturizing Recovery Mask Witch Hazel PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-150_2b18f1f5-c011-43e9-b1bf-22d62b7c7976 69424-150 HUMAN OTC DRUG Leaders Insolution Coconut Gel Balancing Recovery Mask Witch Hazel PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-160_4618dfb3-482f-44a7-9382-ecd1fd325180 69424-160 HUMAN OTC DRUG Leaders Insolution Coconut Brightening Recovery Mask Witch Hazel PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-170_10d9cb95-f1f7-42a6-ba37-fbca43daf8b3 69424-170 HUMAN OTC DRUG Leaders Mediu 2 Step Double Effect Pore Tightening Mask Witch Hazel PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .028 g/28g N 20181231 69424-180_59b149ed-9858-4d2f-94f2-b7b505724311 69424-180 HUMAN OTC DRUG Leaders Mediu 2 Step Double Effect Brightening Mask Witch Hazel PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .028 g/28g N 20181231 69424-190_c4abd3ab-fddf-4c7f-acf5-e2f2f25e7c5f 69424-190 HUMAN OTC DRUG Leaders Mediu 2 Step Double Effect Wrinkle Care Mask Witch Hazel PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .028 g/28g N 20181231 69424-200_3ec5749f-0028-4468-a774-2e3b9e19fd45 69424-200 HUMAN OTC DRUG Leaders Mediu 2 Step Double Effect Moisturizing Mask Witch Hazel PATCH TOPICAL 20141201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .028 g/28g N 20181231 69424-210_e257aa2e-4ed5-445c-a9f6-defa9ed80b60 69424-210 HUMAN OTC DRUG HIMALAYAN CAMELLIA PORE MINIMIZING MASK Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-220_da9279c2-f6d6-480f-9b8c-997a437d84b1 69424-220 HUMAN OTC DRUG AMAZONIAN ACAI ANTI POLLUTION MASK Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-230_d5d1963e-72ff-4367-92b9-55379934c0bc 69424-230 HUMAN OTC DRUG CARIBBEAN COCONUT CALMING MASK Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-240_61937248-db7d-4cd3-9944-a5f586d7ff8a 69424-240 HUMAN OTC DRUG KALAHARI MELON MOISTURIZING MASK Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-250_0cbbab80-94c8-49cb-914e-bb889e978d54 69424-250 HUMAN OTC DRUG MEDITERRANEAN OLIVE BRIGHTENING MASK Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-260_4a199a11-e5fa-4e75-9866-16c50da00b43 69424-260 HUMAN OTC DRUG TROPICAL ANDIROBA NUTRITION MASK Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-270_fafd241b-d43a-477c-ad7b-41d0cb2ba88b 69424-270 HUMAN OTC DRUG Tundra Cranberry Anti Aging Mask Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .03 mg/30mL N 20181231 69424-280_93f7e784-5efc-4ada-bd87-0695c889ae48 69424-280 HUMAN OTC DRUG A Breath of Fresh Air Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-290_d056816d-44ba-4245-b51a-52891c36217a 69424-290 HUMAN OTC DRUG Breakup with your ex skin cells Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-300_e9690990-399c-4cb7-92dd-b0be200f2f25 69424-300 HUMAN OTC DRUG Bye Bye to Dry Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-310_b18ecb2b-ec29-4d27-ac2f-101f67201937 69424-310 HUMAN OTC DRUG Pore Gone For Good Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-320_3ed2b7d6-02f2-40ea-b119-9e0740da767d 69424-320 HUMAN OTC DRUG Stop the Clock Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-330_a4073b7b-8ee4-41a4-a0c3-fa585806d8aa 69424-330 HUMAN OTC DRUG TOO MUCH FUN IN THE SUN Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-340_6a48d178-5ebf-4bb2-b5d2-b7eb2a6deba6 69424-340 HUMAN OTC DRUG What Happened Last Night Witch Hazel PATCH TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL .025 mg/25mL N 20181231 69424-350_7974d5d4-f879-4c53-83af-f8e0f421393f 69424-350 HUMAN OTC DRUG Leaders Coconut Mask with Broccoli Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 30 mg/30mL N 20181231 69424-360_4720ca44-f7b9-419f-acc3-2ffc5c41d520 69424-360 HUMAN OTC DRUG Leaders Coconut Mask with Blueberry Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 30 mg/30mL N 20181231 69424-370_93e74fcd-d605-4078-a932-6aed8c654b52 69424-370 HUMAN OTC DRUG Leaders Coconut Mask with Orange Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 30 mg/30mL N 20181231 69424-380_532700d1-0a29-4501-9911-00a235505672 69424-380 HUMAN OTC DRUG Leaders Coconut Mask with Tomato Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 30 mg/30mL N 20181231 69424-390_165adedf-4635-4b6b-a5e2-0ddd43af3a65 69424-390 HUMAN OTC DRUG Leaders Coconut Lifting Recovery Mask Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 30 mg/30mL N 20181231 69424-400_de4e95ae-413c-44a8-b403-f44cebaf0785 69424-400 HUMAN OTC DRUG Leaders Coconut Moisturizing Recovery Mask Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 30 mg/30mL N 20181231 69424-410_d6624124-615d-4f82-a1cc-cd6dc1ef3919 69424-410 HUMAN OTC DRUG Leaders Coconut Brightening Recovery Mask Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 30 mg/30mL N 20181231 69424-420_eac90faf-3858-4f05-a0e0-b3133595b269 69424-420 HUMAN OTC DRUG Leaders Daily Wonders You Say Dry I Say No More Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 25 mg/25mL N 20181231 69424-430_4863f1ff-2798-4eaf-8f1c-5c710b54308e 69424-430 HUMAN OTC DRUG Leaders Daily Wonders Beat The Clock Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 25 mg/25mL N 20181231 69424-440_dbcdb40f-4905-4ac2-9c87-023171e605ca 69424-440 HUMAN OTC DRUG LEADERS MEDIU BRIGHTENING MILK PACK Glycerin GEL TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. GLYCERIN 2 g/10mL N 20181231 69424-450_f8ee51cd-61f5-4e6d-916a-264f5b69b247 69424-450 HUMAN OTC DRUG LEADERS MEDIU CALMING PEPPERMINT PACK Allantoin GEL TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. ALLANTOIN 51 mg/10mL N 20181231 69424-460_5a5a5546-b06f-483f-ad98-f3073894f5eb 69424-460 HUMAN OTC DRUG Leaders Mediu Clearing Strawberry Pack Glycerin GEL TOPICAL 20151201 UNAPPROVED DRUG OTHER SANSUNG LIFE & SCIENCE CO., LTD. GLYCERIN 6.59 g/10mL N 20181231 69424-470_ce74442b-f093-47fa-8f89-7fe1d1a847ac 69424-470 HUMAN OTC DRUG Leaders Mediu Elasticity Gold Pack Dimethicone GEL TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. DIMETHICONE .2 g/10mL N 20181231 69424-480_360f8df4-eaf1-4ebf-a859-58861265b3d2 69424-480 HUMAN OTC DRUG Leaders Mediu Pore Cleaning Carbonated Pack Allantoin GEL TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. ALLANTOIN 50 mg/10mL N 20181231 69424-490_e87c86d3-defc-41fd-8630-a8850c85ff0a 69424-490 HUMAN OTC DRUG Leaders Mediu Purifying Salt Pack Allantoin GEL TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. ALLANTOIN 50 mg/10mL N 20181231 69424-500_acec05ea-958c-4555-84f1-564a1014d54a 69424-500 HUMAN OTC DRUG Leaders Mediu Glossy Honey Pack Glycerin GEL TOPICAL 20151201 UNAPPROVED DRUG OTHER SANSUNG LIFE & SCIENCE CO., LTD. GLYCERIN 8.99 g/10mL N 20181231 69424-510_fd602d2d-b4c7-4bd3-b813-a40a317d5973 69424-510 HUMAN OTC DRUG Leaders Mediu Moisturizing Jasmine Pack Glycerin GEL TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. GLYCERIN 2 g/10mL N 20181231 69424-520_d260361f-8532-4d51-8ef3-830e437a1cad 69424-520 HUMAN OTC DRUG Leaders Mediu Nutrition Grain Pack Glycerin GEL TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. GLYCERIN 2.01 g/10mL N 20181231 69424-530_94d496de-510c-4eda-b01a-0d824db9267d 69424-530 HUMAN OTC DRUG Leaders Mediu Soothing Aloe Pack Allantoin GEL TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. ALLANTOIN 50 mg/10mL N 20181231 69424-540_b14c4edf-f7c7-43a2-8497-80f23f0e6138 69424-540 HUMAN OTC DRUG Leaders Snail Treatment First Ampoule Mask Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 23 mg/23mL N 20181231 69424-550_1f340cc1-f344-4ea4-8039-0dcae36099eb 69424-550 HUMAN OTC DRUG Leaders Anti Aging First Ampoule Mask Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 23 mg/23mL N 20181231 69424-560_aac96897-95cd-423a-9d54-27e51bd277ed 69424-560 HUMAN OTC DRUG Leaders Illuminating First Ampoule Mask Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 23 mg/23mL N 20181231 69424-570_5bf5e33f-eaa1-4d7e-a1c0-87068272ad9a 69424-570 HUMAN OTC DRUG Leaders Aquatoning First Ampoule Mask Witch Hazel PATCH TOPICAL 20151201 OTC MONOGRAPH FINAL part347 SANSUNG LIFE & SCIENCE CO., LTD. WITCH HAZEL 23 mg/23mL N 20181231 69424-580_48810fd2-1df9-4eda-87bf-097389bcc732 69424-580 HUMAN OTC DRUG LEADERS SUNBUDDY DAILY MOISTURE SUNSCREEN Homosalate, Octocrylene, Octisalate, Avobenzone CREAM TOPICAL 20170210 OTC MONOGRAPH NOT FINAL part352 LEADERS COSMETICS CO.,LTD. HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 6.65; 3.5; 3.15; 2.1 g/70mL; g/70mL; g/70mL; g/70mL N 20181231 69424-590_3944bd66-2871-421d-84ec-1e741a8231ac 69424-590 HUMAN OTC DRUG LEADERS SUNBUDDY ALL OVER SUN AVOBENZONE SPRAY TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 LEADERS COSMETICS CO.,LTD. AVOBENZONE .64 g/90mL N 20181231 69424-600_6087670e-0374-4e16-8dca-b9b936f0d95c 69424-600 HUMAN OTC DRUG LEADERS SUNBUDDY UV CUT SUN Octocrylene, Octinoxate, Octisalate STICK TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 LEADERS COSMETICS CO.,LTD. OCTOCRYLENE; OCTINOXATE; OCTISALATE 1.6; 1.4; 1 g/20g; g/20g; g/20g N 20191231 69425-001_ff0c3001-f76a-46ce-9d33-12f317d5ae76 69425-001 HUMAN OTC DRUG antibacterial Hand Sanitizing wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A Wuhan Bright Paper Factory BENZALKONIUM CHLORIDE .115 g/100g E 20171231 69435-1601_2ebacfa6-c998-5d4c-e054-00144ff8d46c 69435-1601 HUMAN OTC DRUG Spa Pharma Anti-Aging Acocado Cream SPF 25 Listing Octinoxate,Octocrylene, Octisalate, Avobenzone, Homosalate cream CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part352 Peer Pharm Ltd. OCTOCRYLENE; OCTISALATE; HOMOSALATE; OCTINOXATE; AVOBENZONE 5; 5; 2; 7.5; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69435-1602_2b5841ca-8388-2f5c-e054-00144ff88e88 69435-1602 HUMAN OTC DRUG Spa Pharma Moisturizer Cream SPF 50 Homosalate, Octisalate, Octocrylene, Avobenzone, Titanium Dioxide cream CREAM TOPICAL 20160324 OTC MONOGRAPH FINAL part352 Peer Pharm Ltd. TITANIUM DIOXIDE; OCTOCRYLENE; OCTINOXATE; AVOBENZONE; HOMOSALATE; OCTISALATE 3; 5; 7.5; 3; 10; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69435-1603_2edfd9a4-82bd-1e08-e054-00144ff88e88 69435-1603 HUMAN OTC DRUG Spa Pharma Regenerating Pomegranate Cream Octinoxate, Octocrylene, Avobenzone, Homosalate cream CREAM TOPICAL 20160209 OTC MONOGRAPH FINAL part352 Peer Pharm Ltd. OCTOCRYLENE; AVOBENZONE; OCTINOXATE; OCTISALATE; HOMOSALATE 5; 3; 7.5; 5; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69435-1604_2eba7803-fbc8-17fe-e054-00144ff88e88 69435-1604 HUMAN OTC DRUG Spa Pharma Olive Oil Moisturizing Cream Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate cream CREAM TOPICAL 20160209 OTC MONOGRAPH FINAL part352 Peer Pharma Ltd. OCTOCRYLENE; OCTINOXATE; OCTISALATE; HOMOSALATE; AVOBENZONE 5; 7.5; 5; 2; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69435-1605_2edf0676-9940-6d40-e054-00144ff88e88 69435-1605 HUMAN OTC DRUG Spa Pharma BB Cream SPF 50 Homosalate, Octisalate, Octinoxate, Octocrylene, Avobenzone, Titanium Dioxide CREAM TOPICAL 20160324 OTC MONOGRAPH FINAL part352 Peer Pharm Ltd. OCTOCRYLENE; TITANIUM DIOXIDE; HOMOSALATE; OCTISALATE; OCTINOXATE; AVOBENZONE 5; 3; 10; 5; 7.5; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69435-1606_2edee681-c667-035e-e054-00144ff8d46c 69435-1606 HUMAN OTC DRUG Mineralium Hdra Source Moisturizing Protector SPF 25 Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate cream CREAM TOPICAL 20160324 OTC MONOGRAPH FINAL part352 Peer Pharm Ltd. OCTOCRYLENE; OCTINOXATE; OCTISALATE; AVOBENZONE; HOMOSALATE 5; 7.5; 5; 3; 2 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69435-1607_2edfd9a4-82bc-1e08-e054-00144ff88e88 69435-1607 HUMAN OTC DRUG Spa Pharma Multi vitamin Cream SPF 25 Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate CREAM TOPICAL 20160323 OTC MONOGRAPH FINAL part352 Peer Pharm Ltd. OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE; OCTINOXATE 5; 5; 3; 2; 7.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69435-1608_35c88007-95d8-7283-e054-00144ff8d46c 69435-1608 HUMAN OTC DRUG AntiDandruffShampoo pyrithione zinc shampoo SHAMPOO TOPICAL 20160323 OTC MONOGRAPH FINAL part358H Peer Pharm Ltd. PYRITHIONE ZINC 1 g/100mL N 20181231 69435-1609_2edee681-c665-035e-e054-00144ff8d46c 69435-1609 HUMAN OTC DRUG Spa Pharma Day Defense Moisturizing Cream Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate CREAM TOPICAL 20160323 OTC MONOGRAPH FINAL part352 Peer Pharm Ltd. OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE; OCTINOXATE 5; 5; 3; 2; 7.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69435-1610_2edf0676-993f-6d40-e054-00144ff88e88 69435-1610 HUMAN OTC DRUG Matte and Clear Matifying Protector SPF 25 Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate CREAM TOPICAL 20160323 OTC MONOGRAPH FINAL part352 Peer Pharm Ltd. OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE; OCTINOXATE 5; 5; 3; 2; 7.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69435-1701_5e1a757c-35a2-5be1-e053-2a91aa0a81fa 69435-1701 HUMAN OTC DRUG Multi Effect Day Cream SPF 25 Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate CREAM TOPICAL 20160323 OTC MONOGRAPH FINAL part352 Sano International Ltd. OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE; OCTINOXATE 5; 5; 3; 2; 7 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69435-1702_5e1a9769-16a0-1f39-e053-2991aa0a65e0 69435-1702 HUMAN OTC DRUG Gold Cosmetics Bleach Cream hydroquinone cream CREAM TOPICAL 20170605 OTC MONOGRAPH NOT FINAL part358A Peer Pharm Ltd HYDROQUINONE 100 mg/5mg N 20181231 69435-1703_5e1a9769-16aa-1f39-e053-2991aa0a65e0 69435-1703 HUMAN OTC DRUG Gold Cosmetics Bleach Cream Forte hydroquinone cream CREAM TOPICAL 20170605 OTC MONOGRAPH NOT FINAL part358A Peer Pharm Ltd HYDROQUINONE 5 mg/100mg N 20181231 69435-1704_5e1a9769-16b5-1f39-e053-2991aa0a65e0 69435-1704 HUMAN OTC DRUG Gold Cosmetics Adi Clear hydroquinone cream CREAM TOPICAL 20170605 OTC MONOGRAPH NOT FINAL part358A Peer Pharm Ltd HYDROQUINONE 5 mg/100mg N 20181231 69435-1705_5e1a9769-16be-1f39-e053-2991aa0a65e0 69435-1705 HUMAN OTC DRUG Gold Cosmetics Bleach Cream hydroquinone cream CREAM TOPICAL 20170605 OTC MONOGRAPH NOT FINAL part358A Peer Pharm Ltd HYDROQUINONE 5 mg/100mg N 20181231 69436-930_e99d3820-7f23-4d98-a41d-dcb141f80090 69436-930 HUMAN OTC DRUG 999 ITCH RELIEVING HYDROCORTISONE OINTMENT TOPICAL 19890720 OTC MONOGRAPH NOT FINAL part348 Guangdong CR. Shunfeng Pharmaceutical Co Ltd HYDROCORTISONE 1 g/100g E 20171231 69436-931_b80253d2-a37c-4771-816e-6ad4dfc62430 69436-931 HUMAN OTC DRUG 999 ITCH RELIEVING HYDROCORTISONE OINTMENT TOPICAL 19890720 OTC MONOGRAPH NOT FINAL part348 Guangdong CR. Shunfeng Pharmaceutical Co Ltd HYDROCORTISONE 1 g/100g E 20171231 69437-203_7e952ff6-445c-4bca-99a7-c5c608f10222 69437-203 HUMAN PRESCRIPTION DRUG Anaprox DS naproxen sodium TABLET ORAL 20160601 NDA NDA018164 Canton Laboratories NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69437-316_7e952ff6-445c-4bca-99a7-c5c608f10222 69437-316 HUMAN PRESCRIPTION DRUG Naprosyn naproxen TABLET ORAL 20160601 NDA NDA017581 Canton Laboratories NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69437-415_7e952ff6-445c-4bca-99a7-c5c608f10222 69437-415 HUMAN PRESCRIPTION DRUG EC-Naprosyn naproxen TABLET, DELAYED RELEASE ORAL 20160601 NDA NDA020067 Canton Laboratories NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69437-416_7e952ff6-445c-4bca-99a7-c5c608f10222 69437-416 HUMAN PRESCRIPTION DRUG EC-Naprosyn naproxen TABLET, DELAYED RELEASE ORAL 20160601 NDA NDA020067 Canton Laboratories NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69440-007_0b6ced30-4cbe-4b23-88ec-8913cae8e7a5 69440-007 HUMAN OTC DRUG Siterol Lidocaine HCL, Menthol PATCH TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part348 Binger Consulting Corporation LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM 3.99; 1 g/100g; g/100g N 20181231 69440-008_df5baf93-6189-44f1-a6d2-f56a4763010e 69440-008 HUMAN OTC DRUG Thritex Menthol PATCH TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part348 Binger Consulting Corporation MENTHOL, UNSPECIFIED FORM 5 g/100g N 20181231 69440-009_30188a42-80aa-4307-a148-1e4322dfda0f 69440-009 HUMAN OTC DRUG Dermovix Allantoin,Petrolatum PATCH TOPICAL 20150101 OTC MONOGRAPH FINAL part347 Binger Consulting Corporation ALLANTOIN; PETROLATUM 2; 30 g/100g; g/100g E 20171231 69442-030_fed21a5e-2421-45d2-90d2-86dc25f029df 69442-030 HUMAN PRESCRIPTION DRUG MOXATAG amoxicillin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20160115 NDA NDA050813 Vernalis Therapeutics, Inc. AMOXICILLIN 775 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 69442-480_49121b33-5e2e-403f-93e6-2d27c2d1c4f6 69442-480 HUMAN PRESCRIPTION DRUG TUZISTRA XR codeine polistirex and chlorpheniramine polistirex SUSPENSION, EXTENDED RELEASE ORAL 20150531 NDA NDA207768 Vernalis Therapeutics, Inc. CODEINE PHOSPHATE ANHYDROUS; CHLORPHENIRAMINE MALEATE 14.7; 2.8 mg/5mL; mg/5mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] CIII N 20181231 69446-100_a2d1609e-8274-4e19-855f-03a787a3888c 69446-100 HUMAN OTC DRUG Prostaderm camphor PLASTER TOPICAL 20150224 OTC MONOGRAPH NOT FINAL part348 EZP Corporation CAMPHOR (SYNTHETIC) 3 1/1001 E 20171231 69448-001_55ab68d0-c46a-2f41-e054-00144ff88e88 69448-001 HUMAN PRESCRIPTION DRUG MUTAMYCIN Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170725 ANDA ANDA064144 Accord BioPharma Inc. MITOMYCIN 5 mg/10mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 69448-002_55ab68d0-c46a-2f41-e054-00144ff88e88 69448-002 HUMAN PRESCRIPTION DRUG MUTAMYCIN Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170725 ANDA ANDA064144 Accord BioPharma Inc. MITOMYCIN 20 mg/40mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 69448-003_55ab68d0-c46a-2f41-e054-00144ff88e88 69448-003 HUMAN PRESCRIPTION DRUG MUTAMYCIN Mitomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170725 ANDA ANDA064144 Accord BioPharma Inc. MITOMYCIN 40 mg/80mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 69449-1001_1ea4d8e4-9c9d-411c-b543-c9cb1d9ea0d2 69449-1001 HUMAN OTC DRUG REAL SUMMER SODIUM CHLORIDE PATCH TRANSDERMAL 20141208 OTC MONOGRAPH FINAL part349 Kayone SODIUM CHLORIDE .03 g/g E 20171231 69450-701_bdbfe2f2-e476-4e27-9cce-447c4678ee96 69450-701 HUMAN PRESCRIPTION DRUG IC-GREEN Indocyanine Green INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150306 NDA NDA011525 Novadaq Technologies, Inc. INDOCYANINE GREEN 25 mg/1 N 20181231 69451-300_fd5e0b43-dbb3-4d1f-826d-85ab50475605 69451-300 HUMAN PRESCRIPTION DRUG Pennsaid diclofenac sodium SOLUTION TOPICAL 20100424 NDA NDA020947 Nuvo Pharmaceuticals Inc. DICLOFENAC SODIUM 15 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69452-102_a7158dd0-6878-44c4-807c-7e6414145fc9 69452-102 HUMAN PRESCRIPTION DRUG carisoprodol carisoprodol TABLET ORAL 20150401 ANDA ANDA090988 Bionpharma Inc. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 69452-105_5d3110f0-33c8-44a3-b315-cfa102cbfcb8 69452-105 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, FILM COATED ORAL 20141201 ANDA ANDA202859 Bionpharma Inc. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 69452-106_5d3110f0-33c8-44a3-b315-cfa102cbfcb8 69452-106 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, CHEWABLE ORAL 20141201 ANDA ANDA203037 Bionpharma Inc. MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 69452-107_5d3110f0-33c8-44a3-b315-cfa102cbfcb8 69452-107 HUMAN PRESCRIPTION DRUG MONTELUKAST MONTELUKAST TABLET, CHEWABLE ORAL 20141201 ANDA ANDA203037 Bionpharma Inc. MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 69452-108_ca22209a-8c1c-442f-aad1-f013780c5c86 69452-108 HUMAN PRESCRIPTION DRUG Donepezil Hyrochloride 5mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20150701 ANDA ANDA090551 Bionpharma Inc. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 69452-109_ca22209a-8c1c-442f-aad1-f013780c5c86 69452-109 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride 10mg Donepezil Hydrochloride TABLET, FILM COATED ORAL 20150701 ANDA ANDA090551 Bionpharma Inc. DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 69452-110_cf79c89c-205a-4e10-9754-314a36038819 69452-110 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 Bionpharma Inc. ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 69452-111_cf79c89c-205a-4e10-9754-314a36038819 69452-111 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 Bionpharma Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 69452-112_cf79c89c-205a-4e10-9754-314a36038819 69452-112 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 Bionpharma Inc. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 69452-113_cf79c89c-205a-4e10-9754-314a36038819 69452-113 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 Bionpharma Inc. ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 69452-117_1ec6b48d-337a-4802-b993-5358b3705bc1 69452-117 HUMAN PRESCRIPTION DRUG TETRABENAZINE TETRABENAZINE TABLET ORAL 20180115 ANDA ANDA208826 Bionpharma Inc. TETRABENAZINE 12.5 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20191231 69452-118_1ec6b48d-337a-4802-b993-5358b3705bc1 69452-118 HUMAN PRESCRIPTION DRUG TETRABENAZINE TETRABENAZINE TABLET ORAL 20180115 ANDA ANDA208826 Bionpharma Inc. TETRABENAZINE 25 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20191231 69452-128_6c836afa-e5d5-49b4-83af-f912768a7ddc 69452-128 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20151001 ANDA ANDA091220 Bionpharma Inc. GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 69452-129_6c836afa-e5d5-49b4-83af-f912768a7ddc 69452-129 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20151001 ANDA ANDA091220 Bionpharma Inc. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 69452-130_6c836afa-e5d5-49b4-83af-f912768a7ddc 69452-130 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20151001 ANDA ANDA091220 Bionpharma Inc. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 69452-142_46f62583-8d19-4b40-afa2-d822f0a6194d 69452-142 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20160815 ANDA ANDA078720 Bionpharma Inc. AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 69452-143_9bc227b4-565d-465f-8e7d-d07f16160e19 69452-143 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20160815 ANDA ANDA081297 Bionpharma Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 69452-144_9bc227b4-565d-465f-8e7d-d07f16160e19 69452-144 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20160815 ANDA ANDA081297 Bionpharma Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 69452-145_120023df-22fe-4b4a-a4bd-95efc0284378 69452-145 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE ORAL 20160816 ANDA ANDA202539 Bionpharma Inc. PARICALCITOL 1 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 69452-146_120023df-22fe-4b4a-a4bd-95efc0284378 69452-146 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE ORAL 20160816 ANDA ANDA202539 Bionpharma Inc. PARICALCITOL 2 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 69452-147_120023df-22fe-4b4a-a4bd-95efc0284378 69452-147 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol CAPSULE ORAL 20160816 ANDA ANDA202539 Bionpharma Inc. PARICALCITOL 4 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 69452-148_6c931ec1-c337-4e60-ab70-fdd66469cc80 69452-148 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20160920 ANDA ANDA200900 Bionpharma Inc. PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 69452-149_6c931ec1-c337-4e60-ab70-fdd66469cc80 69452-149 HUMAN PRESCRIPTION DRUG PROGESTERONE PROGESTERONE CAPSULE ORAL 20160920 ANDA ANDA200900 Bionpharma Inc. PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 69452-150_7d868f4f-87e1-4627-928d-183b1ee9a71d 69452-150 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE, LIQUID FILLED ORAL 20160715 ANDA ANDA073484 Bionpharma Inc. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 69452-151_a4497003-7763-4bc2-a610-de3ab494e25e 69452-151 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20160615 ANDA ANDA080704 Bionpharma Inc. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 69452-152_061535b3-b0f6-4ca6-b782-044e27d384d6 69452-152 HUMAN PRESCRIPTION DRUG Ethosuximide Ethosuximide CAPSULE, LIQUID FILLED ORAL 20161021 ANDA ANDA040430 Bionpharma Inc. ETHOSUXIMIDE 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69452-153_4643df1c-15d9-2dc9-2cb9-90e902c21a29 69452-153 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20160226 ANDA ANDA090802 BionPharma Inc., TACROLIMUS .5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 69452-154_4643df1c-15d9-2dc9-2cb9-90e902c21a29 69452-154 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20160226 ANDA ANDA090802 BionPharma Inc., TACROLIMUS 1 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 69452-155_4643df1c-15d9-2dc9-2cb9-90e902c21a29 69452-155 HUMAN PRESCRIPTION DRUG Tacrolimus Tacrolimus CAPSULE, GELATIN COATED ORAL 20160226 ANDA ANDA090802 BionPharma Inc., TACROLIMUS 5 mg/1 Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA] N 20181231 69452-156_3cd11e5b-d9f2-fecb-7065-d6eaf67b4e54 69452-156 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20170117 ANDA ANDA204722 Bionpharma Inc., RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 69452-157_3cd11e5b-d9f2-fecb-7065-d6eaf67b4e54 69452-157 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET, ORALLY DISINTEGRATING ORAL 20170117 ANDA ANDA204722 Bionpharma Inc., RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 69452-209_e65d5108-22a2-4d87-a78d-15606f3cc9e2 69452-209 HUMAN PRESCRIPTION DRUG Nimodipine Nimodipine CAPSULE, LIQUID FILLED ORAL 20171121 ANDA ANDA076740 BIONPHARMA INC. NIMODIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 69455-101_a290ef45-d8f7-44b2-88db-c1a6f0ffb87d 69455-101 HUMAN OTC DRUG DRUNK ELEPHANT UMBRA SHEER DEFENSE SPF-30 ZINC OXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Drunk Elephant Distributors, LLC ZINC OXIDE 20 g/100g E 20171231 69456-227_48bc8512-f930-451b-e054-00144ff8d46c 69456-227 HUMAN OTC DRUG BioBlast Pain Relief MENTHOL GEL TOPICAL 20141211 OTC MONOGRAPH NOT FINAL part348 SMART MEDICAL SUPPLIERS INC. MENTHOL 100 mg/mL N 20181231 69457-000_4506bc04-758a-4f66-b4a1-27fa2c73ace3 69457-000 HUMAN OTC DRUG Red Serum Witch Hazel GEL TOPICAL 20150318 OTC MONOGRAPH FINAL part347 LAB & Company Inc. WITCH HAZEL 2.5 g/100g N 20181231 69457-010_6782ed51-f4fb-4217-b5f0-f0aa59319e24 69457-010 HUMAN OTC DRUG DR COLOR EFFECT RED SERUM Witch Hazel CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 LAB & Company Inc. WITCH HAZEL 1 g/40mL N 20181231 69457-020_f39ed457-5abf-42c9-9eed-d3950db3605f 69457-020 HUMAN OTC DRUG DR. COLOR EFFECT RED Niacinamide CREAM TOPICAL 20151201 UNAPPROVED DRUG OTHER LAB & Company Inc. NIACINAMIDE 1 g/50mL N 20181231 69457-030_df53b772-ee2b-4db7-b618-68812664aeb1 69457-030 HUMAN OTC DRUG Dr Vita Clinic Gently Vita Exfoliator Glycerin GEL TOPICAL 20160701 UNAPPROVED DRUG OTHER LAB & Company Inc. GLYCERIN 9.6 g/120mL N 20181231 69457-040_77705ddf-8179-4f55-9546-4245b99bf424 69457-040 HUMAN OTC DRUG CHICA Y CHICO Killing Star Cleanser Glycerin GEL TOPICAL 20160701 UNAPPROVED DRUG OTHER LAB & Company Inc. GLYCERIN 15 g/150mL N 20181231 69457-050_b61e6782-06ce-4c3a-a614-bba7c36a74e4 69457-050 HUMAN OTC DRUG Dr Pore Tightening GLACIAL CLAY FACIAL MASK Kaolin CREAM TOPICAL 20171101 OTC MONOGRAPH FINAL part347 LAB & Company Inc. KAOLIN 8 g/100mL N 20181231 69457-060_bc223786-5e81-4d78-ade1-797276bf69b7 69457-060 HUMAN OTC DRUG Dr Pore Tightening PINK CLAY FACIAL MASK Kaolin CREAM TOPICAL 20171101 OTC MONOGRAPH FINAL part347 LAB & Company Inc. KAOLIN 4 g/100g N 20181231 69458-713_3cad412b-ffdf-4761-b750-0f1485f8a372 69458-713 HUMAN OTC DRUG FLANADOL PRONTO BISMUTH Bismuth Subsalicylate LIQUID ORAL 20160415 OTC MONOGRAPH FINAL part335 Jomex International Llc BISMUTH SUBSALICYLATE 262 mg/15mL E 20171231 69461-000_9274243b-928a-414c-af6f-79abe23846ca 69461-000 HUMAN OTC DRUG Prolongz Damiana, Ginseng STRIP ORAL 20141024 UNAPPROVED HOMEOPATHIC Dalian Jixin Electronic Information Co., Ltd. TURNERA DIFFUSA LEAF; ASIAN GINSENG 1; 1 [hp_X]/1001; [hp_X]/1001 E 20171231 69461-001_24fdfded-5d48-07a4-e054-00144ff8d46c 69461-001 HUMAN OTC DRUG TBX-Free cytisine STRIP ORAL 20151120 UNAPPROVED HOMEOPATHIC Dalian Jixin Electronic Information Co., Ltd. CYTISINE 8 mg/mg E 20171231 69461-002_629b77cf-f844-8640-e053-2991aa0a10a8 69461-002 HUMAN OTC DRUG Eupepsia Thin PAULINIA CUPANA H.B ET K STRIP ORAL 20170324 UNAPPROVED HOMEOPATHIC Dalian Jixin Electronic and Communication Co., Ltd. PAULLINIA CUPANA SEED 1 [hp_X]/1 N 20191231 69463-1001_b48600d6-12c6-499e-9bdc-5b0e7ac6451c 69463-1001 HUMAN OTC DRUG Mecell Rose Coenzyme Q10 Serum Mask Pack GLYCERIN LIQUID TOPICAL 20141208 OTC MONOGRAPH FINAL part347 TERAECO GLYCERIN .03 g/g E 20171231 69463-2001_1088daa2-18b3-4882-9a9e-18b04817957f 69463-2001 HUMAN OTC DRUG Mecell Red Ginseng Collagen 3D Mask Pack GLYCERIN LIQUID TOPICAL 20141208 OTC MONOGRAPH FINAL part347 TERAECO GLYCERIN .03 g/g E 20171231 69466-001_441ba1c2-7668-493b-96be-854f64e32256 69466-001 HUMAN PRESCRIPTION DRUG Vapergy caffeine, green tea, american ginseng SPRAY ORAL 20141218 UNAPPROVED HOMEOPATHIC Vapergy USA LLC CAFFEINE; GREEN TEA LEAF; AMERICAN GINSENG 1; 1; 1 [hp_X]/.45mg; [hp_X]/.45mg; [hp_X]/.45mg Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 69466-002_d539eb56-8336-44b3-8c10-73ace42cd6c4 69466-002 HUMAN PRESCRIPTION DRUG Vapergy Slim bitter orange, caffeine, green tea, peppermint camphor SPRAY ORAL 20141218 UNAPPROVED HOMEOPATHIC Vapergy USA LLC CAFFEINE; BITTER ORANGE OIL; GREEN TEA LEAF; MENTHOL, UNSPECIFIED FORM 1; 6; 6; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] E 20171231 69467-1001_af9b4ee7-3f21-4001-ac2e-f7f0c9e4590f 69467-1001 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20150701 NDA NDA022370 STA3, LLC TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 69468-151_9420a0b5-51f8-45c5-9070-26b70fabaa6f 69468-151 HUMAN PRESCRIPTION DRUG VISTOGARD uridine triacetate GRANULE ORAL 20160301 NDA NDA208159 Wellstat Therapeutics Corporation URIDINE TRIACETATE 951 mg/g Pyrimidine Analog [EPC],Pyrimidines [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 69468-152_29cafd5d-9280-4b9b-9e8a-39cceb68461c 69468-152 HUMAN PRESCRIPTION DRUG XURIDEN uridine triacetate GRANULE ORAL 20150908 NDA NDA208169 Wellstat Therapeutics Corporation URIDINE TRIACETATE 951 mg/g Pyrimidine Analog [EPC],Pyrimidines [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 69469-169_b168ff26-7d82-472e-bdf0-5a214a7dc2ff 69469-169 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20160331 ANDA ANDA079096 Vitamex USA NAPROXEN SODIUM 220 mg/1 N 20181231 69469-457_4dab4c7f-edda-40f2-8621-481041a8b084 69469-457 HUMAN OTC DRUG Acetaminophen Extra Strong Acetaminophen TABLET ORAL 20160229 OTC MONOGRAPH NOT FINAL part343 Vitamex USA ACETAMINOPHEN 500 mg/1 N 20181231 69469-494_9492a630-e7de-46f2-802c-b3620d40cefc 69469-494 HUMAN OTC DRUG Pain Relief Extra Strength Acetaminophen TABLET ORAL 20160731 OTC MONOGRAPH NOT FINAL part343 Vitamex USA ACETAMINOPHEN 500 mg/1 N 20181231 69474-1001_875c883b-70ab-44d2-8297-587e2e9576dd 69474-1001 HUMAN OTC DRUG EVERTOX SPECIAL BATH PREPARATIONS SILICON DIOXIDE POWDER TOPICAL 20150111 UNAPPROVED DRUG OTHER KMTR Co., Ltd. SILICON DIOXIDE 20 g/100g E 20171231 69475-5411_24fc11d4-5d8c-2f53-e054-00144ff8d46c 69475-5411 HUMAN OTC DRUG Derma Breeze Skin Protectant Cream Colloidal Oatmeal CREAM TOPICAL 20150915 OTC MONOGRAPH FINAL part347 Greyson International, Inc. OATMEAL 10 mg/g E 20171231 69481-333_9abd6681-0c5d-4073-b27e-224ca541e516 69481-333 HUMAN OTC DRUG Clarisonic Pore and Blemish Cleanser Acne Treatment Salicylic Acid GEL TOPICAL 20170810 OTC MONOGRAPH FINAL part333D Pacific Bioscience Laboratories, Inc. SALICYLIC ACID 20 mg/mL N 20181231 69481-539_1a56217b-7b74-4985-9732-88a4197c6f6e 69481-539 HUMAN OTC DRUG Clarisonic Mia 2 Facial Sonic Brush with First Aid Beauty Ultra Repair Skin Protectant Colloidal Oatmeal CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 Pacific Bioscience Laboratories, Inc. OATMEAL 5 mg/g N 20181231 69481-593_dbc305b7-8c93-42a8-996a-7921c1fb0328 69481-593 HUMAN OTC DRUG Clarisonic Acne Daily Clarifying Cleanser Salicylic Acid CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Pacific Bioscience Laboratories, Inc. SALICYLIC ACID 20 mg/mL N 20181231 69481-637_9c883875-22e3-45d3-83ef-7e8900b7f711 69481-637 HUMAN OTC DRUG Clarisonic Mia 3 Facial Sonic Cleansing Brush with Dermalogica total eye care broad spectrum SPF 15 sunscreen Titanium Dioxide LOTION TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 Pacific Bioscience Laboratories, Inc. TITANIUM DIOXIDE 45 mg/mL N 20181231 69481-657_252107b4-aa15-426c-ad35-8146fd2e9e49 69481-657 HUMAN OTC DRUG Clarisonic Mia 2 Facial Sonic Cleansing Brush with Supergoop Sun Essentials Avobenzone, Homosalate, Octinoxate, Octisalate and Zinc Oxide KIT 20150301 OTC MONOGRAPH NOT FINAL part352 Pacific Bioscience Laboratories, Inc. N 20181231 69482-450_8c48cc88-fa33-4bb4-b979-c45548276071 69482-450 HUMAN PRESCRIPTION DRUG Okebo doxycycline CAPSULE ORAL 20171120 ANDA ANDA204234 Encore Dermatology Inc. DOXYCYCLINE 100 mg/1 N 20191231 69482-475_3456f496-0043-4401-8fc8-cf1262f3ac96 69482-475 HUMAN PRESCRIPTION DRUG Okebo doxycycline CAPSULE ORAL 20171120 ANDA ANDA204234 Encore Dermatology Inc. DOXYCYCLINE 75 mg/1 N 20191231 69482-600_30fffade-6854-0f85-e054-00144ff88e88 69482-600 HUMAN PRESCRIPTION DRUG Tridesilon Cream desonide 0.05% CREAM TOPICAL 20161001 NDA NDA017010 Encore Dermatology Inc DESONIDE .03 g/60g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69482-700_d72e5673-6cec-401e-818d-0778cf0da87f 69482-700 HUMAN PRESCRIPTION DRUG Impoyz clobetasol propionate CREAM TOPICAL 20180112 NDA NDA209483 Encore Dermatology, Inc CLOBETASOL PROPIONATE .25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 69483-001_3eb84f29-af93-4c37-9ef2-139a5b9c8f6e 69483-001 HUMAN OTC DRUG Dental City Topical Anesthetic Benzocaine GEL DENTAL 20140401 OTC MONOGRAPH NOT FINAL part356 ICP Inc DBA Dental City BENZOCAINE 200 mg/g N 20181231 69483-002_3ebecf87-3b7d-41c4-b279-1d14a55827b6 69483-002 HUMAN OTC DRUG Dental City Topical Anesthetic Benzocaine GEL DENTAL 20140401 OTC MONOGRAPH NOT FINAL part356 ICP Inc DBA Dental City BENZOCAINE 200 mg/g N 20181231 69483-003_345d8d45-a3b0-422a-a024-8607539cd15b 69483-003 HUMAN OTC DRUG Dental City Topical Anesthetic Benzocaine GEL DENTAL 20140401 OTC MONOGRAPH NOT FINAL part356 ICP Inc DBA Dental City BENZOCAINE 200 mg/g N 20181231 69483-004_f9c777e2-c1fe-4c76-b4c9-5a3289bdfefc 69483-004 HUMAN OTC DRUG Dental City Topical Anesthetic Benzocaine GEL DENTAL 20140401 OTC MONOGRAPH NOT FINAL part356 ICP Inc DBA Dental City BENZOCAINE 200 mg/g N 20181231 69483-005_5a52850b-4c5c-44da-bc87-9a423e57cb61 69483-005 HUMAN OTC DRUG Dental City Topical Anesthetic Benzocaine GEL DENTAL 20140401 OTC MONOGRAPH NOT FINAL part356 ICP Inc DBA Dental City BENZOCAINE 200 mg/g N 20181231 69483-006_57423679-d608-4252-9a71-541503ee7953 69483-006 HUMAN OTC DRUG Dental City Topical Anesthetic Benzocaine GEL DENTAL 20140401 OTC MONOGRAPH NOT FINAL part356 ICP Inc DBA Dental City BENZOCAINE 200 mg/g N 20181231 69483-007_5d66c654-b7a1-426e-a686-4e7401c592b6 69483-007 HUMAN OTC DRUG Dental City Topical Anesthetic Benzocaine GEL DENTAL 20140401 OTC MONOGRAPH NOT FINAL part356 ICP Inc DBA Dental City BENZOCAINE 200 mg/g N 20181231 69483-008_4ff93c2e-da9d-4351-a67e-fc42c87ff9f9 69483-008 HUMAN OTC DRUG Dental City Topical Anesthetic Benzocaine GEL DENTAL 20140401 OTC MONOGRAPH NOT FINAL part356 ICP Inc DBA Dental City BENZOCAINE 200 mg/g N 20181231 69483-009_62d31856-279e-4e1d-94aa-238d505c4f38 69483-009 HUMAN OTC DRUG Dental City Topical Anesthetic Benzocaine GEL DENTAL 20140401 OTC MONOGRAPH NOT FINAL part356 ICP Inc DBA Dental City BENZOCAINE 200 mg/g N 20181231 69484-001_c0bb1514-53e3-4e80-9dec-217ef93514b5 69484-001 HUMAN OTC DRUG Tiger Supply Inc Topical Anesthetic Benzocaine GEL DENTAL 20130508 OTC MONOGRAPH NOT FINAL part356 Tiger Supply Inc. BENZOCAINE 200 mg/g N 20181231 69484-002_1d99fb8a-be17-4997-9d59-e9a125a22b34 69484-002 HUMAN OTC DRUG Tiger Supply Inc Topical Anesthetic Benzocaine GEL DENTAL 20130508 OTC MONOGRAPH NOT FINAL part356 Tiger Supply Inc. BENZOCAINE 200 mg/g N 20181231 69484-003_cf1e35c7-fe28-401e-aa7c-e3a099acb10c 69484-003 HUMAN OTC DRUG Tiger Supply Inc Topical Anesthetic Benzocaine GEL DENTAL 20130508 OTC MONOGRAPH NOT FINAL part356 Tiger Supply Inc. BENZOCAINE 200 mg/g N 20181231 69484-004_52aaf0f5-fc94-4e1f-8483-1e937cab0abd 69484-004 HUMAN OTC DRUG Tiger Supply Inc Topical Anesthetic Benzocaine GEL DENTAL 20130508 OTC MONOGRAPH NOT FINAL part356 Tiger Supply Inc. BENZOCAINE 200 mg/g N 20181231 69484-005_3ce27c33-a632-477e-a05b-d896b714070f 69484-005 HUMAN OTC DRUG Tiger Supply Inc Topical Anesthetic Benzocaine GEL DENTAL 20130508 OTC MONOGRAPH NOT FINAL part356 Tiger Supply Inc. BENZOCAINE 200 mg/g N 20181231 69484-006_e1650700-8d86-42e8-b30d-42420e6cdf44 69484-006 HUMAN OTC DRUG Tiger Supply Inc Topical Anesthetic Benzocaine GEL DENTAL 20130508 OTC MONOGRAPH NOT FINAL part356 Tiger Supply Inc. BENZOCAINE 200 mg/g N 20181231 69484-050_6d6dfc5f-16f3-4425-b739-3dafc87f2592 69484-050 HUMAN PRESCRIPTION DRUG Tiger Supply Inc APF Sodium Fluoride GEL DENTAL 20130508 UNAPPROVED DRUG OTHER Tiger Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 69484-051_a0fe373d-770e-40c8-bd97-b867f0b8999a 69484-051 HUMAN PRESCRIPTION DRUG Tiger Supply Inc APF Sodium Fluoride GEL DENTAL 20130508 UNAPPROVED DRUG OTHER Tiger Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 69484-052_36192cbd-6f97-4d31-bdfe-a1c655c6f4ec 69484-052 HUMAN PRESCRIPTION DRUG Tiger Supply Inc APF Sodium Fluoride GEL DENTAL 20130508 UNAPPROVED DRUG OTHER Tiger Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 69484-053_a83a9bc5-2765-4708-91f6-3576c0506e5d 69484-053 HUMAN PRESCRIPTION DRUG Tiger Supply Inc APF Sodium Fluoride GEL DENTAL 20130508 UNAPPROVED DRUG OTHER Tiger Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 69484-054_51e16628-44f5-4e35-a2ec-9d203a6791d5 69484-054 HUMAN PRESCRIPTION DRUG Tiger Supply Inc APF Sodium Fluoride GEL DENTAL 20130508 UNAPPROVED DRUG OTHER Tiger Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 69484-055_758a6f63-876f-4e2c-8de7-9aa0dc786bc8 69484-055 HUMAN PRESCRIPTION DRUG Tiger Supply Inc APF Sodium Fluoride GEL DENTAL 20130508 UNAPPROVED DRUG OTHER Tiger Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 69484-056_c7360895-fc69-405c-9171-6a60f4ca7e9b 69484-056 HUMAN PRESCRIPTION DRUG Tiger Supply Inc APF Sodium Fluoride GEL DENTAL 20130508 UNAPPROVED DRUG OTHER Tiger Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 69484-057_e5827fac-67c2-43d3-b19e-c70ae3a9bdd9 69484-057 HUMAN PRESCRIPTION DRUG Tiger Supply Inc APF Sodium Fluoride GEL DENTAL 20130508 UNAPPROVED DRUG OTHER Tiger Supply Inc SODIUM FLUORIDE 5.6 g/454g N 20181231 69488-001_47a5726f-d31a-50d9-e054-00144ff8d46c 69488-001 HUMAN PRESCRIPTION DRUG NETSPOT 68Ga-DOTATATE KIT INTRAVENOUS 20160601 NDA NDA208547 Advanced Accelerator Applications USA, Inc N 20181231 69489-111_13359655-d630-445e-b354-4a5ae8010d5b 69489-111 HUMAN PRESCRIPTION DRUG TARGADOX doxycycline hyclate TABLET ORAL 20160829 ANDA ANDA062269 Journey Medical Corporation DOXYCYCLINE HYCLATE 50 mg/1 N 20181231 69490-020_f90d372b-be90-4f62-b6ba-49f0e2e4efa5 69490-020 HUMAN PRESCRIPTION DRUG BIOACHES CAPSAICIN , MENTHOL PATCH TOPICAL 20150110 UNAPPROVED DRUG OTHER BIO-SANTEE CHEM CAPSAICIN; MENTHOL .0375; 5 g/1; g/1 E 20171231 69491-030_b885bdc1-9906-4ab3-8f00-a600e1cf2033 69491-030 HUMAN OTC DRUG RON 2 SODIUM MONOFLUOROPHOSPHATE, ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY KIT 20150330 OTC MONOGRAPH FINAL part355 Buzz Export Services Pty., Ltd. N 20181231 69491-060_57536559-4aee-43ec-a36a-9787a2ce3c7e 69491-060 HUMAN OTC DRUG Colgate SODIUM FLUORIDE PASTE DENTAL 20141203 OTC MONOGRAPH FINAL part355 Buzz Export Services Pty., Ltd. SODIUM FLUORIDE 1.5 mg/g N 20181231 69491-070_4d86b96e-88bf-60a3-e054-00144ff8d46c 69491-070 HUMAN OTC DRUG Kit1 SODIUM FLUORIDE KIT 20170124 OTC MONOGRAPH FINAL part355 Buzz Export Services Pty., Ltd. N 20181231 69491-080_4d86b96e-88ca-60a3-e054-00144ff8d46c 69491-080 HUMAN OTC DRUG Kit 2 SODIUM FLUORIDE KIT 20170124 OTC MONOGRAPH FINAL part355 Buzz Export Services Pty., Ltd. N 20181231 69491-085_60ddfb90-d0b1-62e9-e053-2991aa0a590c 69491-085 HUMAN OTC DRUG Dental Kits 1 SODIUM FLUORIDE KIT 20170503 OTC MONOGRAPH FINAL part355 Buzz Export Services Pty., Ltd. N 20181231 69491-086_60ddc3da-b899-4009-e053-2a91aa0a9659 69491-086 HUMAN OTC DRUG Dental Kits 2 SODIUM FLUORIDE KIT 20170503 OTC MONOGRAPH FINAL part355 Buzz Export Services Pty., Ltd. N 20181231 69491-831_c3aca83a-e917-4aff-b024-6c99f44c628c 69491-831 HUMAN OTC DRUG Crest SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20141223 OTC MONOGRAPH FINAL part355 Buzz Export Services Pty., Ltd. SODIUM FLUORIDE 1.5 mg/g N 20181231 69492-011_0ee5cc92-41ed-4f48-9d84-9362934be8ac 69492-011 HUMAN OTC DRUG MIRACTIL Hemorrhoidal Cream GEL TOPICAL 20150520 OTC MONOGRAPH FINAL part346 POLIMEROS Y SERVICIOS S.A- COCOA BUTTER; GLYCERIN; MENTHOL; PETROLATUM; ZINC OXIDE 125; 125; 1; 150; 125 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69492-012_992c195d-5c61-4604-95f0-4d344bebd8a4 69492-012 HUMAN OTC DRUG KLEARACTIL Acne Topical Treatment GEL TOPICAL 20150629 OTC MONOGRAPH FINAL part333D POLIMEROS Y SERVICIOS S.A. SALICYLIC ACID 5 mg/g N 20181231 69492-013_bbd702d0-f986-45f4-a2a9-1059aa7f038b 69492-013 HUMAN OTC DRUG BIOACTIL Pain Relieving GEL TOPICAL 20150702 OTC MONOGRAPH NOT FINAL part348 POLIMEROS Y SERVICIOS S.A. MENTHOL 30 mg/g N 20181231 69492-014_a376a113-8e4c-4105-ae7b-9254e05f9350 69492-014 HUMAN OTC DRUG KERACTIL Plus ANTIFUNGAL GEL TOPICAL 20160309 OTC MONOGRAPH FINAL part333C POLIMEROS Y SERVICIOS S.A. TOLNAFTATE 10 mg/g N 20181231 69492-015_7599a2a1-98e3-4ee4-9618-4484be946dca 69492-015 HUMAN OTC DRUG Polyactil N Skin Protectant GEL TOPICAL 20160620 OTC MONOGRAPH FINAL part347 POLIMEROS Y SERVICIOS S.A. ALLANTOIN 5 mg/g N 20181231 69494-302_2743ccf5-60a6-4fe1-8d6c-da1e835ac591 69494-302 HUMAN OTC DRUG Eryfotona Actinica Ultralight Emulsion Sunscreen EMULSION TOPICAL 20150817 OTC MONOGRAPH FINAL part352 ISDIN Corp ZINC OXIDE 1.1 g/10g N 20181231 69498-001_5bfe91fc-fbbf-4f2d-81f6-20deb40048cf 69498-001 HUMAN OTC DRUG iSmile Topical Anesthetic Benzocaine GEL DENTAL 20140601 OTC MONOGRAPH NOT FINAL part356 iSmile Dental Products, Inc. BENZOCAINE 200 mg/g N 20181231 69498-002_d06677de-2b6d-4804-997d-2ebca2dd97b1 69498-002 HUMAN OTC DRUG iSmile Topical Anesthetic Benzocaine GEL DENTAL 20140601 OTC MONOGRAPH NOT FINAL part356 iSmile Dental Products, Inc. BENZOCAINE 200 mg/g N 20181231 69498-003_a93be008-3549-4c48-acbd-97fee1b652f1 69498-003 HUMAN OTC DRUG iSmile Topical Anesthetic Benzocaine GEL DENTAL 20140601 OTC MONOGRAPH NOT FINAL part356 iSmile Dental Products, Inc. BENZOCAINE 200 mg/g N 20181231 69498-004_08280314-0021-4636-8e6b-abae16157a6e 69498-004 HUMAN OTC DRUG iSmile Topical Anesthetic Benzocaine GEL DENTAL 20140601 OTC MONOGRAPH NOT FINAL part356 iSmile Dental Products, Inc. BENZOCAINE 200 mg/g N 20181231 69498-005_c00be87c-88dc-409b-969f-5b2b41d4f09f 69498-005 HUMAN OTC DRUG iSmile Topical Anesthetic Benzocaine GEL DENTAL 20140601 OTC MONOGRAPH NOT FINAL part356 iSmile Dental Products, Inc. BENZOCAINE 200 mg/g N 20181231 69498-006_4da695bb-89b4-4376-80de-b4acc07508f0 69498-006 HUMAN OTC DRUG iSmile Topical Anesthetic Benzocaine GEL DENTAL 20140601 OTC MONOGRAPH NOT FINAL part356 iSmile Dental Products, Inc. BENZOCAINE 200 mg/g N 20181231 69499-301_b5925ed8-0ad6-4ae6-8683-0ffc6fa0d279 69499-301 HUMAN PRESCRIPTION DRUG Ortho D Folic Acid and Vitamin D3 CAPSULE ORAL 20150808 UNAPPROVED DRUG OTHER Solubiomix FOLIC ACID; VITAMIN D 1; .094 mg/mg; mg/mg Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 69499-318_8c96f879-4753-4838-9c0c-7c149b75e960 69499-318 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM Diclofenac Sodium GEL TOPICAL 20160521 ANDA ANDA208077 Solubiomix DICLOFENAC SODIUM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69499-321_882300e1-5fa3-4637-aa5f-6156209bd1c3 69499-321 HUMAN PRESCRIPTION DRUG metoprolol succinate and hydrochlorothiazide metoprolol succinate and hydrochlorothiazide TABLET ORAL 20170510 NDA NDA021956 Solubiomix METOPROLOL SUCCINATE; HYDROCHLOROTHIAZIDE 25; 12.5 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69499-322_5f85ca7c-e5be-4c9f-b552-75905fd892eb 69499-322 HUMAN PRESCRIPTION DRUG Hydrocortisone 1% in Absorbase Hydrocortisone 1% in Absorbase OINTMENT TOPICAL 20161102 ANDA ANDA088138 Solubiomix HYDROCORTISONE 10 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 69499-323_882300e1-5fa3-4637-aa5f-6156209bd1c3 69499-323 HUMAN PRESCRIPTION DRUG metoprolol succinate and hydrochlorothiazide metoprolol succinate and hydrochlorothiazide TABLET ORAL 20170510 NDA NDA021956 Solubiomix METOPROLOL SUCCINATE; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69499-324_882300e1-5fa3-4637-aa5f-6156209bd1c3 69499-324 HUMAN PRESCRIPTION DRUG metoprolol succinate and hydrochlorothiazide metoprolol succinate and hydrochlorothiazide TABLET ORAL 20170510 NDA NDA021956 Solubiomix METOPROLOL SUCCINATE; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 69499-329_b9aef06d-e976-4920-89de-1abf66144d69 69499-329 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170818 ANDA ANDA040851 Solubiomix BENZONATATE 150 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 69499-330_7db08e9f-77d6-43a2-8685-69e1bb43458a 69499-330 HUMAN PRESCRIPTION DRUG chlorzoxazone chlorzoxazone TABLET ORAL 20170830 ANDA ANDA207483 Solubiomix CHLORZOXAZONE 250 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 69502-001_48a7a01e-3481-45bf-e054-00144ff88e88 69502-001 HUMAN OTC DRUG Touchless Care ANTIFUNGAL Touchless Care ANTIFUNGAL SPRAY TOPICAL 20170228 OTC MONOGRAPH FINAL part333C Crawford Healthcare, Inc. MICONAZOLE NITRATE 2 g/100g N 20181231 69502-002_4cfeabd3-38ec-40d9-e054-00144ff8d46c 69502-002 HUMAN OTC DRUG Touchless Care CLEAR PROTECTANT Touchless Care CLEAR PROTECTANT SPRAY TOPICAL 20170509 OTC MONOGRAPH FINAL part347 Crawford Healthcare, Inc. DIMETHICONE 20 g/100g N 20181231 69502-004_5f10cc6b-8bb0-0b20-e053-2991aa0ac19d 69502-004 HUMAN OTC DRUG Touchless Care ZINC OXIDE PROTECTANT Touchless Care ZINC OXIDE PROTECTANT SPRAY TOPICAL 20151204 OTC MONOGRAPH FINAL part347 Crawford Healthcare, Inc. DIMETHICONE; ZINC OXIDE 20; 25 g/100g; g/100g N 20181231 69502-500_5c4fd5c0-8712-1796-e053-2a91aa0a5b34 69502-500 HUMAN OTC DRUG Touchless Care Antifungal MICONAZOLE NITRATE SPRAY TOPICAL 20141229 20190831 OTC MONOGRAPH FINAL part333C Crawford Healthcare, Inc. MICONAZOLE NITRATE 2 g/100g N 20181231 69502-501_5c4fe34e-26ee-260e-e053-2a91aa0ac9d6 69502-501 HUMAN OTC DRUG Touchless Care CLEAR PROTECTANT DIMETHICONE SPRAY TOPICAL 20141229 20190930 OTC MONOGRAPH FINAL part347 Crawford Healthcare, Inc. DIMETHICONE 20 g/100g N 20181231 69502-503_5c50507b-926d-bf6f-e053-2991aa0ae981 69502-503 HUMAN OTC DRUG Touchless Care ZINC OXIDE PROTECTANT ZINC OXIDE SPRAY TOPICAL 20141229 20180630 OTC MONOGRAPH FINAL part347 Crawford Healthcare, Inc. ZINC OXIDE 25 g/100g N 20181231 69502-504_305ea284-06d6-24c2-e054-00144ff8d46c 69502-504 HUMAN OTC DRUG Touchless Care ZINC OXIDE PROTECTANT Touchless Care ZINC OXIDE PROTECTANT SPRAY TOPICAL 20160414 OTC MONOGRAPH FINAL part347 Crawford Healthcare, Inc. ZINC OXIDE; DIMETHICONE 25; 20 g/100g; g/100g E 20171231 69505-001_c0cfb8e0-d58c-4980-a63e-179f91337004 69505-001 HUMAN OTC DRUG To Save Face SPF 30 Plus Facial Sunscreen Avobenzone, Octocrylene, Oxybenzone, Phenylbenzimidazole sulfonic acid CREAM TOPICAL 20141229 OTC MONOGRAPH NOT FINAL part352 Mecca Brands Pty Ltd AVOBENZONE; OXYBENZONE; ENSULIZOLE; OCTOCRYLENE 1; 1.5; 2; 5 g/100g; g/100g; g/100g; g/100g N 20181231 69509-001_2bbb2cb8-4126-4d80-af77-326bba0f9c9f 69509-001 HUMAN OTC DRUG Primo Topical Anesthetic Benzocaine GEL DENTAL 20140301 OTC MONOGRAPH NOT FINAL part356 Tri State Dental BENZOCAINE 200 mg/g N 20181231 69509-002_f9c31b54-254e-4f9f-9deb-7fc3d39275ec 69509-002 HUMAN OTC DRUG Primo Topical Anesthetic Benzocaine GEL DENTAL 20140301 OTC MONOGRAPH NOT FINAL part356 Tri State Dental BENZOCAINE 200 mg/g N 20181231 69509-003_687f57f7-2360-402e-8259-cd9eaa740b8b 69509-003 HUMAN OTC DRUG Primo Topical Anesthetic Benzocaine GEL DENTAL 20140301 OTC MONOGRAPH NOT FINAL part356 Tri State Dental BENZOCAINE 200 mg/g N 20181231 69509-004_901ae69c-1cf5-4504-ab85-47b0c3612aae 69509-004 HUMAN OTC DRUG Primo Topical Anesthetic Benzocaine GEL DENTAL 20140301 OTC MONOGRAPH NOT FINAL part356 Tri State Dental BENZOCAINE 200 mg/g N 20181231 69509-005_16c6c4b7-6540-4a1d-8416-e060953fb9fb 69509-005 HUMAN OTC DRUG Primo Topical Anesthetic Benzocaine GEL DENTAL 20140301 OTC MONOGRAPH NOT FINAL part356 Tri State Dental BENZOCAINE 200 mg/g N 20181231 69509-006_a2b4945f-01bb-4a0a-ac66-519956ea583f 69509-006 HUMAN OTC DRUG Primo Topical Anesthetic Benzocaine GEL DENTAL 20140301 OTC MONOGRAPH NOT FINAL part356 Tri State Dental BENZOCAINE 200 mg/g N 20181231 69509-007_be7000fa-cc01-4dd5-ab81-9d42818ad794 69509-007 HUMAN OTC DRUG Primo Topical Anesthetic Benzocaine GEL DENTAL 20140301 OTC MONOGRAPH NOT FINAL part356 Tri State Dental BENZOCAINE 200 mg/g N 20181231 69509-008_cee24d5a-ca8d-4018-8857-bf3a57fdba43 69509-008 HUMAN OTC DRUG Primo Topical Anesthetic Benzocaine GEL DENTAL 20140301 OTC MONOGRAPH NOT FINAL part356 Tri State Dental BENZOCAINE 200 mg/g N 20181231 69509-009_1acd0935-0a6c-46c4-be7c-692481d8419f 69509-009 HUMAN OTC DRUG Primo Topical Anesthetic Benzocaine GEL DENTAL 20140301 OTC MONOGRAPH NOT FINAL part356 Tri State Dental BENZOCAINE 200 mg/g N 20181231 69509-050_0740e475-0638-444f-82b1-93623b7d3fcc 69509-050 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride GEL DENTAL 20130901 UNAPPROVED DRUG OTHER Tri State Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 69509-051_95834572-8c23-47e8-a027-6e140d14bec1 69509-051 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride GEL DENTAL 20130901 UNAPPROVED DRUG OTHER Tri State Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 69509-052_0b02b276-e724-414b-98c8-078d7093f704 69509-052 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride GEL DENTAL 20130901 UNAPPROVED DRUG OTHER Tri State Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 69509-053_e53f35b6-f2e4-4506-a3f7-10a7f8b2472f 69509-053 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride GEL DENTAL 20130901 UNAPPROVED DRUG OTHER Tri State Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 69509-054_12af0921-4e71-40f7-bb9b-d51472bc1f50 69509-054 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride GEL DENTAL 20130901 UNAPPROVED DRUG OTHER Tri State Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 69509-055_54052762-cc91-4471-b558-dd98bf931cbe 69509-055 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride GEL DENTAL 20130901 UNAPPROVED DRUG OTHER Tri State Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 69509-056_cf7ea0eb-78ee-42fb-9292-89de418581b1 69509-056 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride GEL DENTAL 20130901 UNAPPROVED DRUG OTHER Tri State Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 69509-057_56f453af-bd5c-4290-b084-9da34ebb2c97 69509-057 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride GEL DENTAL 20130901 UNAPPROVED DRUG OTHER Tri State Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 69509-058_006a6dd9-e9d4-4515-b99d-0b71f13c6efb 69509-058 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride GEL DENTAL 20130901 UNAPPROVED DRUG OTHER Tri State Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 69509-059_9dcba564-7c6b-472c-9276-a1ca4c06777f 69509-059 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride GEL DENTAL 20130901 UNAPPROVED DRUG OTHER Tri State Dental SODIUM FLUORIDE 5.6 g/454g N 20181231 69509-075_b892f02a-d559-4926-b569-ba0818c984f2 69509-075 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130801 UNAPPROVED DRUG OTHER Tri State Dental Supply SODIUM FLUORIDE 1.5375 g/125g E 20171231 69509-076_a530e5e7-f391-4af7-9137-f673fc454378 69509-076 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130801 UNAPPROVED DRUG OTHER Tri State Dental Supply SODIUM FLUORIDE 1.5375 g/125g E 20171231 69509-077_44ffa8c4-3449-4c39-9028-d9629ac6453d 69509-077 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130801 UNAPPROVED DRUG OTHER Tri State Dental Supply SODIUM FLUORIDE 1.5375 g/125g E 20171231 69509-078_61614abb-a27f-4e8b-9f82-bef4aeef4088 69509-078 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130801 UNAPPROVED DRUG OTHER Tri State Dental Supply SODIUM FLUORIDE 1.5375 g/125g E 20171231 69509-079_1d161c9c-8e75-4e40-a038-997b5a23db23 69509-079 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130801 UNAPPROVED DRUG OTHER Tri State Dental Supply SODIUM FLUORIDE 1.5375 g/125g E 20171231 69509-080_892925ce-bccf-4427-8e0c-fb39f5b7c3d6 69509-080 HUMAN PRESCRIPTION DRUG Primo APF Sodium Fluoride AEROSOL, FOAM DENTAL 20130801 UNAPPROVED DRUG OTHER Tri State Dental Supply SODIUM FLUORIDE 1.5375 g/125g E 20171231 69510-010_442e8091-cbe5-4c61-e054-00144ff8d46c 69510-010 HUMAN OTC DRUG Ipana Wintergreen Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20141231 OTC MONOGRAPH FINAL part355 Maxill Inc. SODIUM MONOFLUOROPHOSPHATE .1 g/100g N 20181231 69510-020_442e8091-cbe4-4c61-e054-00144ff8d46c 69510-020 HUMAN OTC DRUG Ipana Bucky Beaver Bubble Gum Childrens Fluoride SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20141231 OTC MONOGRAPH FINAL part355 Maxill Inc SODIUM MONOFLUOROPHOSPHATE .1 g/100g N 20181231 69510-351_442e8dd5-0c56-4cba-e054-00144ff8d46c 69510-351 HUMAN OTC DRUG Ipana 20% Benzocaine Topical Benzocaine GEL DENTAL 20160801 OTC MONOGRAPH NOT FINAL part356 Maxill Inc. BENZOCAINE 200 mg/g N 20181231 69510-352_442e8dd5-0c55-4cba-e054-00144ff8d46c 69510-352 HUMAN OTC DRUG Ipana 20% Benzocaine Topical Benzocaine GEL DENTAL 20160801 OTC MONOGRAPH NOT FINAL part356 Maxill Inc. BENZOCAINE 200 mg/g N 20181231 69510-353_442e8dd5-0c57-4cba-e054-00144ff8d46c 69510-353 HUMAN OTC DRUG Ipana 20% Benzocaine Topical Benzocaine GEL DENTAL 20160801 OTC MONOGRAPH NOT FINAL part356 Maxill Inc. BENZOCAINE 200 mg/g N 20181231 69510-355_442e8091-cbe3-4c61-e054-00144ff8d46c 69510-355 HUMAN OTC DRUG Ipana 20% Benzocaine Topical Benzocaine GEL DENTAL 20160801 OTC MONOGRAPH NOT FINAL part356 Maxill Inc. BENZOCAINE 200 mg/g N 20181231 69510-358_442e8091-cbe2-4c61-e054-00144ff8d46c 69510-358 HUMAN OTC DRUG Ipana 20% Benzocaine Topical Benzocaine GEL DENTAL 20160801 OTC MONOGRAPH NOT FINAL part356 Maxill Inc. BENZOCAINE 200 mg/g N 20181231 69515-010_27faa897-bd9b-4711-9fef-4ce7a70eaeb2 69515-010 HUMAN OTC DRUG TREEANNSEA ESKIMO MELLA TIME RELEASE AGE DEFINE Witch Hazel CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 PINE TORTE GROUP CO., LTD. WITCH HAZEL .025 mg/50mL E 20171231 69515-020_4c11040b-f450-4331-bde9-e7d2f988e4d8 69515-020 HUMAN OTC DRUG TREEANNSEA ESKIMO MELLA PLEASURE WHITENING SERUM Witch Hazel CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 PINE TORTE GROUP CO., LTD. WITCH HAZEL .015 mg/30mL E 20171231 69515-030_5f902406-94b3-4bc5-9534-866180dd3422 69515-030 HUMAN OTC DRUG TREEANNSEA ESKIMO MELLA FERTILE SOOTHING TONER Witch Hazel CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 PINE TORTE GROUP CO., LTD. WITCH HAZEL .1 mg/200mL E 20171231 69515-040_bcd8a3d4-6a01-4438-bf62-d2486733d140 69515-040 HUMAN OTC DRUG TREEANNSEA DESERT ROSE Witch Hazel CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 PINE TORTE GROUP CO., LTD. WITCH HAZEL .025 mg/50mL E 20171231 69515-050_21e7309b-d729-48c1-87f8-e0f02085c0f0 69515-050 HUMAN OTC DRUG TREEANNSEA DESERT ROSE SERUM Witch Hazel CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 PINE TORTE GROUP CO., LTD. WITCH HAZEL .015 mg/30mL E 20171231 69516-005_d7cea5d6-ee56-4bbc-a831-e4170ce99f75 69516-005 HUMAN PRESCRIPTION DRUG Ocaliva Obeticholic Acid TABLET, FILM COATED ORAL 20160527 NDA NDA207999 Intercept Pharmaceuticals Inc OBETICHOLIC ACID 5 mg/1 Farnesoid X Receptor Agonist [EPC],Farnesoid X Receptor Agonists [MoA] N 20181231 69516-010_d7cea5d6-ee56-4bbc-a831-e4170ce99f75 69516-010 HUMAN PRESCRIPTION DRUG Ocaliva Obeticholic Acid TABLET, FILM COATED ORAL 20160527 NDA NDA207999 Intercept Pharmaceuticals Inc OBETICHOLIC ACID 10 mg/1 Farnesoid X Receptor Agonist [EPC],Farnesoid X Receptor Agonists [MoA] N 20181231 69517-102_878b622e-e442-4b40-a762-4e1e24b2ecba 69517-102 HUMAN OTC DRUG DayTime Cold and Flu Relief Acetaminophen, Dextromethorphan, Phenylephrine CAPSULE, LIQUID FILLED ORAL 20150826 OTC MONOGRAPH FINAL part341 HealthLife of USA ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 69517-103_eaf74a7f-6ff4-4cd8-a9ee-815e8b540e25 69517-103 HUMAN OTC DRUG NightTime Cold and Flu Relief Acetaminophen, Dextromethorphan, Doxylamine CAPSULE, LIQUID FILLED ORAL 20150826 OTC MONOGRAPH FINAL part341 HealthLife of USA ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 10; 6.25 mg/1; mg/1; mg/1 N 20181231 69517-104_1d953087-c818-4eca-b4f9-e8900b52b5bc 69517-104 HUMAN OTC DRUG Pain Reliever Aspirin 81 mg TABLET, DELAYED RELEASE ORAL 20160209 OTC MONOGRAPH FINAL part343 HealthLife Of USA ASPIRIN 81 mg/1 N 20181231 69517-105_a83c8a95-bdb2-48d0-a8a4-f44e742303bd 69517-105 HUMAN OTC DRUG Extra Strength Headache Relief Extra Strength Headache Relief TABLET, COATED ORAL 20170531 OTC MONOGRAPH NOT FINAL part343 Healthlife of USA ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; 1/1 N 20181231 69517-106_4b4ba2e4-1184-469c-a31d-f8e11d948eb7 69517-106 HUMAN OTC DRUG Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20120512 OTC MONOGRAPH FINAL part341 HealthLife of USA DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69517-107_031e5f7c-e333-4d45-9ff4-8ec7aa110c97 69517-107 HUMAN OTC DRUG Extra Strenghth Acetaminophen Acetaminophen TABLET ORAL 20170731 OTC MONOGRAPH NOT FINAL part343 HealthLife of USA ACETAMINOPHEN 500 mg/1 N 20181231 69517-109_046b91ed-d78b-42c0-b822-77fcbdeff84b 69517-109 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium Tablets, 220 mg TABLET ORAL 20110930 ANDA ANDA091353 HealthLife of USA LLC NAPROXEN SODIUM 220 mg/1 N 20181231 69517-110_8edf919c-9195-4aeb-b399-ff72a0dd8b3e 69517-110 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl 25 mg TABLET, COATED ORAL 20170601 OTC MONOGRAPH FINAL part341 HealthLife of USA DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69517-111_8e733e89-3460-49b9-a157-4f2f91bb14cc 69517-111 HUMAN OTC DRUG Fast Pain Relief Ibuprofen TABLET, COATED ORAL 20110101 ANDA ANDA079174 HealthLife of USA LLC IBUPROFEN 200 mg/1 N 20181231 69517-113_2424fb86-c3c9-4da7-9684-46dfda9589d1 69517-113 HUMAN OTC DRUG Pain Reliever PM Acetaminophen and Diphenhydramine Hydrochloride TABLET ORAL 20160209 OTC MONOGRAPH NOT FINAL part343 HealthLife of USA ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 69517-115_302c0de9-75df-470b-9b04-91d4e84c8e09 69517-115 HUMAN OTC DRUG Extra Strength Aspirin Extra Strength Aspirin TABLET ORAL 20170531 OTC MONOGRAPH FINAL part343 Healthlife of USA ASPIRIN 325 mg/1 N 20181231 69517-116_fbd42a73-2982-4c09-8415-ae7cb0a8e3a1 69517-116 HUMAN OTC DRUG Gentle Laxative Gentle Laxative TABLET ORAL 20170531 OTC MONOGRAPH NOT FINAL part334 Healthlife of USA BISACODYL 5 mg/1 N 20181231 69517-117_e6151411-aef9-4ea1-a1f2-476f346500d1 69517-117 HUMAN OTC DRUG Maximum Strength Nighttime Sleep-Aid Diphenhydramine HCL CAPSULE, LIQUID FILLED ORAL 20170502 OTC MONOGRAPH FINAL part338 Healthlife of USA DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 69517-118_b41d1018-e792-4c29-a27e-27ec9575091a 69517-118 HUMAN OTC DRUG Tension Headache Relief Acetaminophen 500mg TABLET, COATED ORAL 20170531 OTC MONOGRAPH NOT FINAL part343 Healthlife of USA ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 69517-119_16f64d2f-c2bc-4d05-8ae7-2cf4d6b32799 69517-119 HUMAN OTC DRUG Mucus Relief Guaifenesin 400 mg TABLET ORAL 20160413 OTC MONOGRAPH FINAL part341 HealthLife of USA LLC GUAIFENESIN 400 mg/1 N 20181231 69517-120_8fd09ca2-da81-4b87-acc3-5c5e87648fe4 69517-120 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr Tablets TABLET ORAL 20170531 OTC MONOGRAPH FINAL part341 Healthlife of USA LLC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 15 mg/1; mg/1 N 20181231 69517-123_72dbab68-3a5e-4bf0-83b0-2e30d9802fab 69517-123 HUMAN OTC DRUG Regular Strength Pain Reliever Acetaminophen TABLET ORAL 20171218 OTC MONOGRAPH NOT FINAL part343 Healthlife of USA ACETAMINOPHEN 325 mg/1 N 20181231 69517-124_3ecad082-b2b7-4e64-a7b7-c6287acdbf33 69517-124 HUMAN OTC DRUG Gentle Relief Stool Softner Gentle Relief Stool Softnet CAPSULE, GELATIN COATED ORAL 20170531 OTC MONOGRAPH NOT FINAL part334 Healthlife of USA DOCUSATE SODIUM 100 mg/1 N 20181231 69517-130_9c56638a-0134-419f-9497-7f7fc084fdd4 69517-130 HUMAN OTC DRUG Menstrual Complete Menstrual Complete TABLET, COATED ORAL 20170531 OTC MONOGRAPH NOT FINAL part343 Healthlife of USA ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20191231 69517-131_db488a26-b345-4a35-a311-1de16c5376d8 69517-131 HUMAN OTC DRUG SENNA-S Senna and Docusate Sodium Tablets, 8.6 mg and 50 mg TABLET, COATED ORAL 20160307 OTC MONOGRAPH NOT FINAL part334 HealthLife of USA LLC SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 69517-132_a1fc8313-77fd-44bf-84b0-d5aa76456811 69517-132 HUMAN OTC DRUG Alertness Aid Stay Awake Caffeine TABLET ORAL 20170531 OTC MONOGRAPH FINAL part340 Healthlife of USA CAFFEINE 200 mg/1 N 20181231 69517-133_655eff44-14f5-4209-bcf3-ffc34f9648e1 69517-133 HUMAN PRESCRIPTION DRUG Ferrous Sulfate Iron Supplement Therapy TABLET ORAL 20171205 UNAPPROVED DRUG OTHER Healthlife of USA FERROUS SULFATE 65 mg/1 N 20181231 69517-136_62030708-06a6-425b-a736-a458821cb145 69517-136 HUMAN OTC DRUG Low Dose Aspirin Chewable Aspirin TABLET, CHEWABLE ORAL 20171009 OTC MONOGRAPH NOT FINAL part343 Healthlife of USA ASPIRIN 81 mg/1 N 20181231 69517-142_a69b4a77-a65d-4978-8526-4cfe7995319b 69517-142 HUMAN OTC DRUG COLDTAC ULTRA Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg TABLET ORAL 20171002 OTC MONOGRAPH FINAL part341 Healthlife of USA ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20181231 69517-145_553b6ae7-9b08-4461-b453-1e7df0baf143 69517-145 HUMAN OTC DRUG Senna Laxative Sennosides TABLET ORAL 20171204 OTC MONOGRAPH NOT FINAL part334 Healthlife of USA SENNOSIDES 8.6 mg/1 N 20181231 69517-609_b058d8d9-ee85-4242-948a-7fe035d6506c 69517-609 HUMAN OTC DRUG Saline Saline SPRAY NASAL 20180110 OTC MONOGRAPH FINAL part349 Healthlife of USA SODIUM CHLORIDE 6.5 mg/mL N 20191231 69517-613_92d09450-1763-4d3d-b3da-a802f15ede64 69517-613 HUMAN OTC DRUG 12 Hour Nasal Oxymetazoline HCL SPRAY NASAL 20180102 OTC MONOGRAPH FINAL part341 Healthlife of USA OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL N 20191231 69517-623_f8817ce4-96d0-4ac3-a2d2-700281db9fd6 69517-623 HUMAN OTC DRUG Acetaminophen Acetaminophen SUSPENSION ORAL 20180109 OTC MONOGRAPH NOT FINAL part343 Healthlife of USA ACETAMINOPHEN 160 mg/100mL N 20191231 69517-624_04190e88-3b24-4b34-8b2f-1c4b16e2fc1e 69517-624 HUMAN OTC DRUG Acetaminophen Acetaminophen SUSPENSION ORAL 20180110 OTC MONOGRAPH NOT FINAL part343 Healthlife of USA ACETAMINOPHEN 160 mg/100mL N 20191231 69517-627_a006562d-548e-445c-98a3-4dc8b1c62617 69517-627 HUMAN OTC DRUG Acetaminophen Acetaminophen SUSPENSION ORAL 20180110 OTC MONOGRAPH NOT FINAL part343 Healthlife of USA ACETAMINOPHEN 160 mg/100mL N 20191231 69517-628_aa0f4d08-931d-41b5-8dd3-82e24fadc765 69517-628 HUMAN OTC DRUG Acetaminophen Acetaminophen SUSPENSION ORAL 20180109 OTC MONOGRAPH NOT FINAL part343 Healthlife of USA ACETAMINOPHEN 160 mg/100mL N 20191231 69519-0101_752b54dc-4ab9-46b2-b10c-4fcc07e09876 69519-0101 HUMAN OTC DRUG Shuifulan High-Efficiency Anti-Bacteria Monomer Silver Gel for Women Anti-Bacteria Monomer Silver Gel for Women GEL, DENTIFRICE VAGINAL 20150109 UNAPPROVED HOMEOPATHIC SHUIFULAN (BEIJING) BIOLOGICAL TECHNOLOGY CO., LTD SILVER 350 ug/3g E 20171231 69520-525_47f4f989-fab7-6576-e054-00144ff8d46c 69520-525 HUMAN OTC DRUG Docs SKINCARE NATURAL SUNSCREEN SPF30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20150108 OTC MONOGRAPH NOT FINAL part352 Doc's Skincare LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 69521-011_616aa460-7858-9f4d-e053-2a91aa0a5d58 69521-011 HUMAN PRESCRIPTION DRUG SmartPractice topical anesthetic gel Mint benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER SmartHealth, Inc. (DBA SmartPractice) BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 69521-021_616aa460-7858-9f4d-e053-2a91aa0a5d58 69521-021 HUMAN PRESCRIPTION DRUG SmartPractice topical anesthetic gel Cherry benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER SmartHealth, Inc. (DBA SmartPractice) BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 69521-031_616aa460-7858-9f4d-e053-2a91aa0a5d58 69521-031 HUMAN PRESCRIPTION DRUG SmartPractice topical anesthetic gel Bubble Gum benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER SmartHealth, Inc. (DBA SmartPractice) BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 69521-041_616aa460-7858-9f4d-e053-2a91aa0a5d58 69521-041 HUMAN PRESCRIPTION DRUG SmartPractice topical anesthetic gel Pina Colada benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER SmartHealth, Inc. (DBA SmartPractice) BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 69521-051_616aa460-7858-9f4d-e053-2a91aa0a5d58 69521-051 HUMAN PRESCRIPTION DRUG SmartPractice topical anesthetic gel Strawberry benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER SmartHealth, Inc. (DBA SmartPractice) BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 69521-061_616aa460-7858-9f4d-e053-2a91aa0a5d58 69521-061 HUMAN PRESCRIPTION DRUG SmartPractice topical anesthetic gel Raspberry benzocaine GEL DENTAL 19630219 UNAPPROVED DRUG OTHER SmartHealth, Inc. (DBA SmartPractice) BENZOCAINE 220 mg/g Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient] N 20181231 69522-1111_f1830c6d-aac1-4117-bdbc-776e057f0a47 69522-1111 HUMAN OTC DRUG Dollar Shave Club Sodium fluoride PASTE, DENTIFRICE DENTAL 20171101 OTC MONOGRAPH FINAL part355 Dollar Shave Club SODIUM FLUORIDE 1.5 mg/g N 20191231 69522-2315_428f7672-f61f-4baf-b3ae-8c5619adabcb 69522-2315 HUMAN OTC DRUG Big Cloud Sky Master Lip Balm SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene LIPSTICK TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part352 Dollar Shave Club AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 70; 50; 27.5 mg/g; mg/g; mg/g; mg/g N 20191231 69522-2612_2f721120-1f2e-43d3-873c-317593dd1345 69522-2612 HUMAN OTC DRUG Dollar Shave Club Daily Face Moisturizer Broad Spectrum SPF 25 octinoxate and zinc oxide CREAM TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 DOLLAR SHAVE CLUB, INC. OCTINOXATE; ZINC OXIDE 70; 40 mg/g; mg/g N 20191231 69524-555_492419ef-c659-3880-e054-00144ff8d46c 69524-555 HUMAN OTC DRUG Allegenal-M BENZOCAINE CREAM TOPICAL 20150128 OTC MONOGRAPH FINAL part348 Halal Nutritional Center BENZOCAINE 7.5 g/100g N 20181231 69525-1001_c21d4229-dae8-45dc-8871-6cf47cf36780 69525-1001 HUMAN OTC DRUG YOZUM SECRET GLYCERIN SHAMPOO TOPICAL 20141208 OTC MONOGRAPH FINAL part347 YOZUM KOREA GLYCERIN 2.5 g/100mL E 20171231 69525-2001_d75cccd1-ee37-4de7-8c22-7a93adde203c 69525-2001 HUMAN OTC DRUG YOZUM WELL BEING HAIR COLOR DEXPANTHENOL LIQUID TOPICAL 20141208 OTC MONOGRAPH NOT FINAL part347 YOZUM KOREA DEXPANTHENOL .2 g/100g E 20171231 69527-122_b5d7c9e5-d0dd-42a1-acc3-5e0f477a263a 69527-122 HUMAN OTC DRUG DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS PYRITHIONE ZINC SHAMPOO TOPICAL 20120114 OTC MONOGRAPH FINAL part358H .McBride Research Laboratories, Inc. PYRITHIONE ZINC 10 mg/mL E 20171231 69530-856_392af68b-60ec-421f-a03b-74fa8e337b60 69530-856 HUMAN OTC DRUG CLn Acne Cleanser Salicylic acid 0.5% LIQUID TOPICAL 20150301 OTC MONOGRAPH FINAL part333D TopMD Skin Care SALICYLIC ACID 5 mg/mL E 20171231 69533-101_a968433e-8f78-40be-abc6-fa6656f64b9e 69533-101 HUMAN OTC DRUG Natural Tinted Sun-cream Titanium Dioxide CREAM TOPICAL 20150121 OTC MONOGRAPH NOT FINAL part352 aromatica co. TITANIUM DIOXIDE .1175 1/50mL N 20181231 69533-102_91f3f9ab-8138-4cfd-ad36-9121bb1c3166 69533-102 HUMAN OTC DRUG Calendula Non-nano UV Protection Unscented SPF30PA Zinc Oxide,Titanium Dioxide CREAM TOPICAL 20150722 OTC MONOGRAPH NOT FINAL part352 aromatica co. ZINC OXIDE; TITANIUM DIOXIDE .18; .025 1/50g; 1/50g N 20181231 69533-110_53c2735b-f9c5-42c6-ba38-a5be76c0e389 69533-110 HUMAN OTC DRUG NATURAL TINTED SUN SPF30 Titanium Dioxide CREAM TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part352 aromatica co. TITANIUM DIOXIDE .1175 1/50mL N 20181231 69533-111_9184613b-eb2b-407c-a62b-3c6897052a8f 69533-111 HUMAN OTC DRUG CALENDULA NON-NANO UV PROTECTION UNSCENTED SPF30 Zinc Oxide,Titanium Dioxide CREAM TOPICAL 20151204 OTC MONOGRAPH NOT FINAL part352 aromatica co. ZINC OXIDE; TITANIUM DIOXIDE .18; .025 1/50g; 1/50g N 20181231 69533-112_61d045bd-06ce-406a-b8e7-563e490afe9c 69533-112 HUMAN OTC DRUG NATURAL TINTED SUN COVER CUSHION - LIGHT BEIGE Titanium Dioxide LIQUID TOPICAL 20160902 OTC MONOGRAPH NOT FINAL part352 aromatica co. TITANIUM DIOXIDE 1.98 g/17g N 20181231 69533-113_f710cbd7-b7a8-4b41-b4d3-85a0ff56aca8 69533-113 HUMAN OTC DRUG NATURAL TINTED SUN COVER CUSHION - NATURAL BEIGE Titanium Dioxide LIQUID TOPICAL 20160902 OTC MONOGRAPH NOT FINAL part352 aromatica co. TITANIUM DIOXIDE 1.98 g/17g N 20181231 69533-114_867c9af9-f565-45de-920a-2478aeac82e8 69533-114 HUMAN OTC DRUG JERRYS BABY NON-NANO SUN CUSHION ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20170306 OTC MONOGRAPH NOT FINAL part352 aromatica co. ZINC OXIDE; TITANIUM DIOXIDE 2.7; .37 g/15g; g/15g N 20181231 69533-115_3e6fe48f-a56d-4219-a1ef-c70c0e74df47 69533-115 HUMAN OTC DRUG NATURAL TINTED SUN SPF30 TITANIUM DIOXIDE CREAM TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 aromatica co. TITANIUM DIOXIDE 5.85 g/50mL N 20181231 69533-116_ee2ffcb1-c5a3-4d5b-b9a5-4d916a7bea69 69533-116 HUMAN OTC DRUG CALENDULA NON-NANO UV PROTECTION UNSCENTED SPF30 Zinc Oxide,Titanium Dioxide CREAM TOPICAL 20170328 OTC MONOGRAPH NOT FINAL part352 aromatica co. ZINC OXIDE; TITANIUM DIOXIDE 12.6; 1.806 g/70g; g/70g N 20181231 69534-001_4e0c76f8-693f-4dff-808f-3ab92643f915 69534-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20150101 UNAPPROVED MEDICAL GAS Northern Illinois Home Medical Supply OXYGEN 99 L/100L E 20171231 69535-002_6145267e-9ae6-23ed-e053-2991aa0a9593 69535-002 HUMAN OTC DRUG me4kidz Antiseptic Towlette BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20150115 OTC MONOGRAPH NOT FINAL part333A ME4KIDZ, LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 69535-413_3bf94dae-47b4-4745-a4bb-8f4a3800d151 69535-413 HUMAN OTC DRUG BZK benzalkonium chloride LIQUID TOPICAL 20150121 OTC MONOGRAPH NOT FINAL part333E Me4Kids BENZALKONIUM CHLORIDE .0013 g/g N 20181231 69536-025_86972f05-cf76-458a-bfc2-35c75610c3be 69536-025 HUMAN OTC DRUG Neo-Synephrine Cold and Sinus Mild Strength Phenylephrine hydrochloride SPRAY NASAL 20140715 OTC MONOGRAPH FINAL part341 Foundation Consumer Healthcare LLC PHENYLEPHRINE HYDROCHLORIDE .25 g/100mL N 20181231 69536-050_a930b2e2-51cf-4288-a246-6162856cc303 69536-050 HUMAN OTC DRUG Neo-Synephrine Cold and Sinus Regular Strength Phenylephrine hydrochloride SPRAY NASAL 20140715 OTC MONOGRAPH FINAL part341 Foundation Consumer Healthcare LLC PHENYLEPHRINE HYDROCHLORIDE .5 g/100mL N 20181231 69536-100_d30b729d-dfcc-4970-a4b9-66fedd7fba03 69536-100 HUMAN OTC DRUG Neo-Synephrine Cold and Sinus Extra Strength Phenylephrine hydrochloride SPRAY NASAL 20140715 OTC MONOGRAPH FINAL part341 Foundation Consumer Healthcare LLC PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 69536-108_71aa6616-a4c9-4dc1-bdf5-760ed965b983 69536-108 HUMAN OTC DRUG Campho-Phenique Cold Sore Treatment CAMPHOR (SYNTHETIC) and PHENOL GEL TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part348 Foundation Consumer Healthcare LLC CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 g/100g; g/100g N 20181231 69536-109_f5dee990-4d19-4bd8-862b-74cc666e48c4 69536-109 HUMAN OTC DRUG Campho-Phenique Antiseptic CAMPHOR (SYNTHETIC) and PHENOL GEL TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Foundation Consumer Healthcare LLC CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 g/100g; g/100g N 20181231 69536-110_f8f78e3d-5696-43cf-b5d4-e65eca4aa29e 69536-110 HUMAN OTC DRUG Campho-Phenique Antiseptic CAMPHOR (SYNTHETIC) and PHENOL LIQUID TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Foundation Consumer Healthcare LLC CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 mg/100mL; mg/100mL N 20181231 69536-125_e2ad8161-e886-4a27-93e2-313cca782764 69536-125 HUMAN OTC DRUG Neo-Synephrine Mild Strength Phenylephrine hydrochloride SPRAY NASAL 20170630 OTC MONOGRAPH FINAL part341 Foundation Consumer Healthcare LLC PHENYLEPHRINE HYDROCHLORIDE .25 g/100mL N 20181231 69536-150_eb9bfe23-0420-491c-af76-c10b9c28cde3 69536-150 HUMAN OTC DRUG Neo-Synephrine Regular Strength Phenylephrine hydrochloride SPRAY NASAL 20170630 OTC MONOGRAPH FINAL part341 Foundation Consumer Healthcare LLC PHENYLEPHRINE HYDROCHLORIDE .5 g/100mL N 20181231 69536-175_9fc6db3a-d023-4704-8cfe-a90fb23033e7 69536-175 HUMAN OTC DRUG Neo-Synephrine Extra Strength Phenylephrine hydrochloride SPRAY NASAL 20170630 OTC MONOGRAPH FINAL part341 Foundation Consumer Healthcare LLC PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 69536-181_caa4bcf3-2876-4899-8285-eec4e3569ec9 69536-181 HUMAN OTC DRUG St. Joseph Low Dose Aspirin Aspirin TABLET, FILM COATED ORAL 20140530 OTC MONOGRAPH NOT FINAL part343 Foundation Consumer Healthcare ASPIRIN 81 mg/1 N 20181231 69536-281_b8b91b8f-f689-453b-b81c-53c22cdf79e1 69536-281 HUMAN OTC DRUG St. Joseph Chewable Low Dose Aspirin ASPIRIN TABLET, CHEWABLE ORAL 20120305 OTC MONOGRAPH NOT FINAL part343 Foundation Consumer Healthcare LLC ASPIRIN 81 mg/1 N 20181231 69536-425_4528a201-937a-4c81-be74-d8fc89733243 69536-425 HUMAN OTC DRUG Bronkaid Dual Action Formula EPHEDRINE SULFATE and GUAIFENESIN TABLET, COATED ORAL 20060101 OTC MONOGRAPH FINAL part341 Foundation Consumer Healthcare LLC EPHEDRINE SULFATE; GUAIFENESIN 25; 400 mg/1; mg/1 N 20181231 69538-100_af61a280-7cbb-4a87-af5b-1cf8667b6b50 69538-100 HUMAN OTC DRUG Wipe n Go Benzalkonium Chloride SWAB TOPICAL 20150821 OTC MONOGRAPH NOT FINAL part333A CANADIA USA CORPORATION BENZALKONIUM CHLORIDE .13 g/100g E 20171231 69538-200_62f8e696-98ae-4ed1-b059-fc0fe710cab4 69538-200 HUMAN OTC DRUG Wipe n Go Benzalkonium Chloride SWAB TOPICAL 20150824 OTC MONOGRAPH NOT FINAL part333A CANADIA USA CORPORATION BENZALKONIUM CHLORIDE .13 g/100g E 20171231 69539-006_377ddc7e-ebd1-4b86-a523-73566438f64f 69539-006 HUMAN PRESCRIPTION DRUG Moxifloxacin Hydrochloride Tablets, 400 mg Moxifloxacin Hydrochloride Tablets, 400 mg TABLET, FILM COATED ORAL 20170922 ANDA ANDA208682 MSN LABORATORIES PRIVATE LIMITED MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 69539-007_5b8b1b70-5ea0-4421-8431-60a5dab98b8d 69539-007 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20171122 ANDA ANDA208898 MSN LABORATORIES PRIVATE LIMITED ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69539-008_5b8b1b70-5ea0-4421-8431-60a5dab98b8d 69539-008 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20171122 ANDA ANDA208898 MSN LABORATORIES PRIVATE LIMITED ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69539-009_5b8b1b70-5ea0-4421-8431-60a5dab98b8d 69539-009 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20171122 ANDA ANDA208898 MSN LABORATORIES PRIVATE LIMITED ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69539-010_5b8b1b70-5ea0-4421-8431-60a5dab98b8d 69539-010 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20171122 ANDA ANDA208898 MSN LABORATORIES PRIVATE LIMITED ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 69540-0009_1394fb38-1262-4631-9f08-edb6ab6d2721 69540-0009 HUMAN OTC DRUG Clorox Lemon Dish Chloroxylenol SOAP TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part333E Brand Buzz CHLOROXYLENOL .003 g/mL E 20171231 69540-0012_16339ea4-29c8-42f3-9b5e-251d708a45bf 69540-0012 HUMAN OTC DRUG Clorox Citrus and Sage Dish Chloroxylenol SOAP TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part333E Brand Buzz CHLOROXYLENOL .003 g/mL E 20171231 69540-0018_11329479-5583-4a2b-91c4-3c93bbcc5513 69540-0018 HUMAN OTC DRUG Clorox Oxi Dish Oxi Magic Chloroxylenol SOAP TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part333E Brand Buzz CHLOROXYLENOL .003 g/mL E 20171231 69540-0074_f9e06da5-aebf-47cf-9095-847c7e3ddacf 69540-0074 HUMAN OTC DRUG Clorox Antibacterial Hand - Coconut Water Chloroxylenol SOAP TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part333E Brand Buzz CHLOROXYLENOL .003 g/mL E 20171231 69540-0075_fc2aaceb-3b93-41b1-af24-5c42c6b47909 69540-0075 HUMAN OTC DRUG Clorox Antibacterial Hand - Wild Lavender and Vanilla Chloroxylenol SOAP TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part333E Brand Buzz CHLOROXYLENOL .003 g/mL E 20171231 69540-0076_39f32a22-206e-42ed-bb7f-50d13f9e6105 69540-0076 HUMAN OTC DRUG Clorox Antibacterial Hand - Cherry and Magnolia Blossom Chloroxylenol SOAP TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part333E Brand Buzz CHLOROXYLENOL .003 g/mL E 20171231 69540-0078_57056486-30a3-4c79-a8ad-fa1bca678fe6 69540-0078 HUMAN OTC DRUG Clorox Antibacterial Hand - Citrus Blossom Chloroxylenol SOAP TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part333E Brand Buzz CHLOROXYLENOL .003 g/mL E 20171231 69541-001_96353da4-58df-4423-b37b-e4a8150dd349 69541-001 HUMAN OTC DRUG ASD 3-in-1 salicylic acid GEL TOPICAL 20150123 OTC MONOGRAPH FINAL part333D Almen Cosmetic Group AB SALICYLIC ACID 2 g/100g E 20171231 69542-555_4807fb60-8d25-6e61-e054-00144ff8d46c 69542-555 HUMAN OTC DRUG Kay Medic Menthol Pain Relief MENTHOL CREAM TOPICAL 20150121 OTC MONOGRAPH NOT FINAL part348 Kay Medic LLC MENTHOL 30 mg/mL N 20181231 69543-101_8af23f5a-28e8-4149-b683-38d597a381f2 69543-101 HUMAN PRESCRIPTION DRUG Cephalexin cephalexin CAPSULE ORAL 20150602 ANDA ANDA062713 Virtus Pharmaceuticals CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] E 20171231 69543-102_8af23f5a-28e8-4149-b683-38d597a381f2 69543-102 HUMAN PRESCRIPTION DRUG Cephalexin cephalexin CAPSULE ORAL 20150602 ANDA ANDA062713 Virtus Pharmaceuticals CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 69543-107_1fa717a4-02be-4732-afe1-06aad59afa6a 69543-107 HUMAN PRESCRIPTION DRUG Desloratadine Desloratadine TABLET ORAL 20150612 ANDA ANDA078355 Virtus Pharmaceuticals DESLORATADINE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 69543-120_947e3973-c1bd-4495-bce6-d377a4f99a00 69543-120 HUMAN PRESCRIPTION DRUG acarbose acarbose TABLET ORAL 20150201 ANDA ANDA091343 Virtus Pharmaceuticals LLC ACARBOSE 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 69543-121_947e3973-c1bd-4495-bce6-d377a4f99a00 69543-121 HUMAN PRESCRIPTION DRUG acarbose acarbose TABLET ORAL 20150201 ANDA ANDA091343 Virtus Pharmaceuticals LLC ACARBOSE 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 69543-122_947e3973-c1bd-4495-bce6-d377a4f99a00 69543-122 HUMAN PRESCRIPTION DRUG acarbose acarbose TABLET ORAL 20150201 ANDA ANDA091343 Virtus Pharmaceuticals LLC ACARBOSE 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] N 20181231 69543-123_8144b28c-de1a-4371-8187-da2d77c52730 69543-123 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20150714 ANDA ANDA202112 Virtus Pharmaceuticals GLIMEPIRIDE 1 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 69543-124_8144b28c-de1a-4371-8187-da2d77c52730 69543-124 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20150714 ANDA ANDA202112 Virtus Pharmaceuticals GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 69543-125_8144b28c-de1a-4371-8187-da2d77c52730 69543-125 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20150714 ANDA ANDA202112 Virtus Pharmaceuticals GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 69543-130_3db54f06-4f05-40ad-bff3-0bac4a4ab3cf 69543-130 HUMAN PRESCRIPTION DRUG Alendronate ALENDRONATE SODIUM TABLET ORAL 20150930 ANDA ANDA090258 Virtus Pharmaceuticals ALENDRONATE SODIUM 35 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 69543-131_3db54f06-4f05-40ad-bff3-0bac4a4ab3cf 69543-131 HUMAN PRESCRIPTION DRUG Alendronate ALENDRONATE SODIUM TABLET ORAL 20150930 ANDA ANDA090258 Virtus Pharmaceuticals ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 69543-134_eb0e6196-125e-4357-9f18-7779bc553565 69543-134 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20150713 ANDA ANDA200958 Virtus Pharmaceuticals METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 69543-135_eb0e6196-125e-4357-9f18-7779bc553565 69543-135 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20150713 ANDA ANDA200958 Virtus Pharmaceuticals METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 69543-136_982b4377-986d-4b74-8be4-9fea9f1ccaeb 69543-136 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE Tramadol hydrochloride TABLET ORAL 20150522 ANDA ANDA091498 Virtus Pharmaceuticals TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 69543-140_48269e03-eee6-4941-8d9e-f6b76ad3af5b 69543-140 HUMAN PRESCRIPTION DRUG Losartan Losartan Potassium TABLET, FILM COATED ORAL 20150714 ANDA ANDA090382 Virtus Pharmaceuticals LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 69543-141_48269e03-eee6-4941-8d9e-f6b76ad3af5b 69543-141 HUMAN PRESCRIPTION DRUG Losartan Losartan Potassium TABLET, FILM COATED ORAL 20150714 ANDA ANDA090382 Virtus Pharmaceuticals LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 69543-142_48269e03-eee6-4941-8d9e-f6b76ad3af5b 69543-142 HUMAN PRESCRIPTION DRUG Losartan Losartan Potassium TABLET, FILM COATED ORAL 20150714 ANDA ANDA090382 Virtus Pharmaceuticals LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 69543-150_4cefaf77-53ad-4a92-95c6-20ae61c25117 69543-150 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20160601 ANDA ANDA204074 Virtus Pharmaceuticals DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 69543-151_4cefaf77-53ad-4a92-95c6-20ae61c25117 69543-151 HUMAN PRESCRIPTION DRUG Dapsone Dapsone TABLET ORAL 20160601 ANDA ANDA204074 Virtus Pharmaceuticals DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 69543-217_29dc153a-084a-4046-ba0c-7f45b4000d87 69543-217 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20150908 OTC MONOGRAPH FINAL part331 Virtus Pharmaceuticals MAGNESIUM OXIDE 400 mg/1 N 20181231 69543-252_5f8953e2-3144-4e9a-8a50-c296003fb82b 69543-252 HUMAN OTC DRUG Virtussin A/C Codeine phosphate and Guaifenesin LIQUID ORAL 20150707 OTC MONOGRAPH FINAL part341 Virtus Pharmaceuticals CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV N 20181231 69543-253_af5db79b-cb25-4bf4-ad93-461516c05bd0 69543-253 HUMAN OTC DRUG Virtussin DAC Codeine phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride LIQUID ORAL 20150825 OTC MONOGRAPH FINAL part341 Virtus Pharmaceuticals CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 100; 30 mg/5mL; mg/5mL; mg/5mL CV N 20181231 69543-276_069e4225-31b7-4cd1-86f1-7aaceea44810 69543-276 HUMAN OTC DRUG Codeine Phosphate and Guaifenesin Codeine Phosphate and Guaifenesin LIQUID ORAL 20171023 OTC MONOGRAPH FINAL part341 Virtus Pharmaceuticals LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV N 20181231 69543-372_de1e405b-1c2c-4db3-a72b-e4f0c4b52979 69543-372 HUMAN PRESCRIPTION DRUG Prometrium Progesterone CAPSULE ORAL 20160715 NDA NDA019781 Virtus Pharmaceuticals PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 69543-373_de1e405b-1c2c-4db3-a72b-e4f0c4b52979 69543-373 HUMAN PRESCRIPTION DRUG Prometrium Progesterone CAPSULE ORAL 20160715 NDA NDA019781 Virtus Pharmaceuticals PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 69543-374_7c12a4ed-d63e-4173-a309-518424f12e17 69543-374 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20160713 NDA NDA019781 Virtus Pharmaceuticals PROGESTERONE 100 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 69543-375_7c12a4ed-d63e-4173-a309-518424f12e17 69543-375 HUMAN PRESCRIPTION DRUG Progesterone Progesterone CAPSULE ORAL 20160713 NDA NDA019781 Virtus Pharmaceuticals PROGESTERONE 200 mg/1 Progesterone [Chemical/Ingredient],Progesterone [EPC] N 20181231 69543-376_854942e7-57aa-43ed-82b8-5b32d514f322 69543-376 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20170213 ANDA ANDA202755 Virtus Pharmaceuticals, LLC TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 69543-379_8ab5d386-06ce-459d-96a6-8bb3a3ae7198 69543-379 HUMAN PRESCRIPTION DRUG Potassium Chloride for Oral Solution Potassium Chloride POWDER, FOR SOLUTION ORAL 20170109 NDA NDA208019 Virtus Pharmaceuticals POTASSIUM CHLORIDE 1.5 g/1.58g Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 69543-380_08693674-1935-4fb5-b439-9f4a98e78355 69543-380 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20180119 ANDA ANDA204319 Virtus Pharmaceuticals, LLC OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20191231 69543-381_08693674-1935-4fb5-b439-9f4a98e78355 69543-381 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20180119 ANDA ANDA204319 Virtus Pharmaceuticals, LLC OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20191231 69543-382_08693674-1935-4fb5-b439-9f4a98e78355 69543-382 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20180119 ANDA ANDA204319 Virtus Pharmaceuticals, LLC OLANZAPINE 7.5 mg/1 Atypical Antipsychotic [EPC] N 20191231 69543-383_08693674-1935-4fb5-b439-9f4a98e78355 69543-383 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20180119 ANDA ANDA204319 Virtus Pharmaceuticals, LLC OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20191231 69543-384_08693674-1935-4fb5-b439-9f4a98e78355 69543-384 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20180119 ANDA ANDA204319 Virtus Pharmaceuticals, LLC OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20191231 69543-385_08693674-1935-4fb5-b439-9f4a98e78355 69543-385 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20180119 ANDA ANDA204319 Virtus Pharmaceuticals, LLC OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20191231 69543-386_8f2010fa-38fd-44e4-80d7-2e418206fc41 69543-386 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170915 ANDA ANDA209900 Virtus Pharmaceuticals, LLC KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 69544-152_48bcef3e-6eaa-3f84-e054-00144ff88e88 69544-152 HUMAN OTC DRUG ALGOMEND Pain Relief MENTHOL CREAM TOPICAL 20150121 OTC MONOGRAPH NOT FINAL part348 Cytosome LLC MENTHOL 20 mg/mL N 20181231 69546-311_a1136221-fe82-4942-a87a-96332cbec41c 69546-311 HUMAN OTC DRUG Presage Moisturizer SPF 15 Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 ASA Universal Inc. dba: Sonage ZINC OXIDE; TITANIUM DIOXIDE 5; 2.5 g/100g; g/100g N 20181231 69546-312_ece3cfaf-149c-4b4b-bc1c-80e77e0b9c6f 69546-312 HUMAN OTC DRUG PROTEC Plus NATURAL SPF 30 Zinc Oxide CREAM TOPICAL 20160415 OTC MONOGRAPH NOT FINAL part352 ASA Universal Inc. dba: SONAGE ZINC OXIDE 13.5 g/100g N 20191231 69547-212_609f6b16-c8b2-4d68-94ff-172d547d94b5 69547-212 HUMAN PRESCRIPTION DRUG Narcan naloxone hydrochloride SPRAY NASAL 20170124 NDA NDA208411 Adapt Pharma Inc NALOXONE HYDROCHLORIDE 2 mg/.1mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 69547-353_609f6b16-c8b2-4d68-94ff-172d547d94b5 69547-353 HUMAN PRESCRIPTION DRUG Narcan Naloxone Hydrochloride SPRAY NASAL 20170124 NDA NDA208411 Adapt Pharma Inc NALOXONE HYDROCHLORIDE 4 mg/.1mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 69549-001_40e77de7-50df-4017-bc44-d026ff39f2a0 69549-001 HUMAN OTC DRUG Blurred Lines CC Creme Broad Spectrum SPF 20 Shade 01 Light Octinoxate, Octocrylene, Zinc Oxide, Avobenzone, Titanium Dioxide CREAM TOPICAL 20150117 OTC MONOGRAPH NOT FINAL part352 Color Prevails LLC OCTINOXATE; OCTOCRYLENE; ZINC OXIDE; AVOBENZONE; TITANIUM DIOXIDE 75; 50; 30; 30; 15 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 69549-002_e182d2e3-b06b-4442-87ed-bd6cc5bbea3d 69549-002 HUMAN OTC DRUG Blurred Lines CC Creme Broad Spectrum SPF 20 Shade 02 Medium Octinoxate, Octocrylene, Zinc Oxide, Avobenzone, Titanium Dioxide CREAM TOPICAL 20150117 OTC MONOGRAPH NOT FINAL part352 Color Prevails LLC OCTINOXATE; OCTOCRYLENE; ZINC OXIDE; AVOBENZONE; TITANIUM DIOXIDE 75; 50; 30; 30; 15 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 69549-003_1ebbfeca-1b07-41ba-ab5e-df9a230ae236 69549-003 HUMAN OTC DRUG Blurred Lines CC Creme Broad Spectrum SPF 20 Shade 03 Medium/Dark Octinoxate, Octocrylene, Zinc Oxide, Avobenzone, Titanium Dioxide CREAM TOPICAL 20150120 OTC MONOGRAPH NOT FINAL part352 Color Prevails LLC OCTINOXATE; OCTOCRYLENE; ZINC OXIDE; AVOBENZONE; TITANIUM DIOXIDE 75; 50; 30; 30; 15 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 69550-324_1a3d7f0a-8558-45c5-e054-00144ff88e88 69550-324 HUMAN OTC DRUG Assist II Anorectal (Hemorrhoidal) Benzocaine LIQUID TOPICAL 20150706 OTC MONOGRAPH FINAL part346 Texas Electrolysis Supply BENZOCAINE 20 g/100mL E 20171231 69554-524_c07015a3-ac43-4b2d-8f79-de7c528a362b 69554-524 HUMAN OTC DRUG GENERATIONS ANTIMICROBIAL CHLOROXYLENOL SOAP TOPICAL 20150126 OTC MONOGRAPH NOT FINAL part333E Cole Papers CHLOROXYLENOL 3 g/1000mL E 20171231 69555-020_18066519-f0f8-355b-e054-00144ff88e88 69555-020 HUMAN OTC DRUG Stream2Sea Broad Spectrum 20 Titanium Dioxide LOTION TOPICAL 20150701 OTC MONOGRAPH FINAL part352 Stream2Sea, Inc. TITANIUM DIOXIDE 1 g/66mL E 20171231 69555-030_18066519-f0f8-355b-e054-00144ff88e88 69555-030 HUMAN OTC DRUG Stream2Sea Broad Spectrum 30 Titanium Dioxide LOTION TOPICAL 20150701 OTC MONOGRAPH FINAL part352 Stream2Sea, Inc. TITANIUM DIOXIDE 1 g/88mL E 20171231 69556-001_2bf11a5d-fa88-6a1e-e054-00144ff88e88 69556-001 HUMAN OTC DRUG Hand Sanitizer with Aloe Vera ETHYL ALCOHOL GEL TOPICAL 20160217 OTC MONOGRAPH NOT FINAL part333E Kentron Healthcare, Inc. ALCOHOL 62 mL/100mL N 20181231 69556-002_50c00a56-85b4-2d13-e054-00144ff88e88 69556-002 HUMAN OTC DRUG Instant Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20170504 OTC MONOGRAPH NOT FINAL part333E Kentron Healthcare, Inc. CHLOROXYLENOL 5 mg/mL N 20181231 69556-650_1abd06e0-0559-405c-bd52-39e4dc9d1901 69556-650 HUMAN OTC DRUG Alcohol Prep Pad Medium ISOPROPYL ALCOHOL LIQUID TOPICAL 20150122 OTC MONOGRAPH NOT FINAL part333A Kentron HealthCare, Inc. ISOPROPYL ALCOHOL 70 g/100g N 20181231 69558-001_6158d472-db6d-0e01-e053-2991aa0a9310 69558-001 HUMAN OTC DRUG Antimicrobial Alcohol Hand wipes ALCOHOL LIQUID TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333E GERI GENTILE CORP ALCOHOL 65.9 g/100g N 20181231 69559-3921_19e6f005-58b1-416b-a6ab-7e0340cb9e20 69559-3921 HUMAN OTC DRUG MOMR Rumaian Herbal Bandage L-Menthol, Methyl Salicylate PATCH TOPICAL 20141223 OTC MONOGRAPH NOT FINAL part348 MARYHELEN ORIENTAL MEDICINE RESEARCH LEVOMENTHOL; METHYL SALICYLATE .09; .3 g/1; g/1 E 20171231 69561-463_89072c07-9695-4c5e-83fc-81eaa488b929 69561-463 HUMAN OTC DRUG Lidothal Relief Menthol, Lidocaine PATCH TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part348 Henan Kangdi Medical Devices Co. Ltd. MENTHOL; LIDOCAINE 1; 4 g/100g; g/100g N 20181231 69562-022_85d11e40-f0bc-45b9-94dc-e84456191eda 69562-022 HUMAN OTC DRUG Dr. Spensers Natural Herbal Pain Relief MENTHOL CREAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part356 LTC Health Corp MENTHOL, UNSPECIFIED FORM 2.625 g/75g E 20171231 69565-550_47f4dfd4-b871-4c18-e054-00144ff88e88 69565-550 HUMAN OTC DRUG LOP Homeopathic Hair Conditioning for Eliminating Lice and Nits Natrum Muriaticum LOTION TOPICAL 20150127 UNAPPROVED HOMEOPATHIC Mannel USA, LLC SODIUM CHLORIDE 12 [hp_X]/mL N 20181231 69567-001_c409af60-2beb-4bcb-b1d8-ddcadc34ea56 69567-001 HUMAN OTC DRUG Extra Strength Acetaminophen 500 mg Acetaminophen TABLET ORAL 20160102 OTC MONOGRAPH NOT FINAL part343 Laboratorios Induquimica S.A. ACETAMINOPHEN 500 mg/1 N 20181231 69568-1001_d96d69ad-8726-49aa-ae9b-039034c3ffcb 69568-1001 HUMAN OTC DRUG V.S. Power / Vacsu Power (Dynamic and Powerful 99 year life) Ginseng Concentrated Extracts LIQUID ORAL 20150128 UNAPPROVED DRUG OTHER Mercylignt ASIAN GINSENG .5 g/20mL E 20171231 69568-2001_1973636c-668d-69b7-e054-00144ff88e88 69568-2001 HUMAN OTC DRUG Baek Su Hee (joy 99 year life) (20ml) Ginseng Concentrated Extracts LIQUID ORAL 20150626 UNAPPROVED DRUG OTHER Mercylight ASIAN GINSENG .5 g/20mL E 20171231 69569-001_4532f13b-61c4-727a-e054-00144ff88e88 69569-001 HUMAN OTC DRUG Bioven Naja Naja STRIP ORAL 20150215 UNAPPROVED HOMEOPATHIC Red Mountain, Inc. NAJA NAJA VENOM 10 [hp_X]/1 N 20181231 69570-102_1c30d89e-c1e0-431c-b5ee-f3680e556268 69570-102 HUMAN OTC DRUG HAND AND SKIN SHIELD DIMETHICONE GEL TOPICAL 20150408 OTC MONOGRAPH FINAL part347 DCG Vision Marketing & Sales International Ltd. DIMETHICONE; MINERAL OIL 1; .2 g/100mL; g/100mL N 20181231 69571-001_4b93bfc5-81a1-4d12-bfaf-5fab86eedb05 69571-001 HUMAN OTC DRUG Assured LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20150128 OTC MONOGRAPH NOT FINAL part348 Anhui NHU Pharmaceutical Co., Ltd. LIDOCAINE HYDROCHLORIDE 2.5 g/100g E 20171231 69571-002_4bcbeede-2e42-4b73-ad7a-cba9b7048e32 69571-002 HUMAN OTC DRUG Assured LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20151226 OTC MONOGRAPH NOT FINAL part348 Anhui NHU Pharmaceutical Co., Ltd. LIDOCAINE HYDROCHLORIDE 2.5 g/100g N 20181231 69571-003_6ab86e3f-3a20-4c3b-be50-4bca443cd163 69571-003 HUMAN OTC DRUG Family wellness BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE OINTMENT TOPICAL 20170222 OTC MONOGRAPH FINAL part333B FRONT PHARMACEUTICAL PLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE .41; .0035; .52 g/100g; g/100g; g/100g N 20181231 69571-004_4044ce22-4c7a-433f-8a7a-2e3f24526f66 69571-004 HUMAN OTC DRUG Family Wellness GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUM CREAM TOPICAL 20170314 OTC MONOGRAPH FINAL part346 FRONT PHARMACEUTICAL PLC GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g N 20181231 69571-005_2df0b439-9a31-4d26-99ab-f6dc7e90f696 69571-005 HUMAN OTC DRUG Family Wellness DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE CREAM TOPICAL 20170329 OTC MONOGRAPH NOT FINAL part348 FRONT PHARMACEUTICAL PLC DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 2; .1 g/100g; g/100g N 20181231 69571-006_4015347b-a7f1-4919-814c-527fbd1c1ab9 69571-006 HUMAN OTC DRUG Family wellness Mineral oil, Petrolatum, Phenylephrine HCl OINTMENT TOPICAL 20170330 OTC MONOGRAPH FINAL part346 FRONT PHARMACEUTICAL PLC MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 69571-007_2c03d7cd-b1df-4fb1-9638-b2238c1ffa0f 69571-007 HUMAN OTC DRUG Family Wellness Antiseptic and Pain Relief BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE OINTMENT TOPICAL 20170613 OTC MONOGRAPH FINAL part333B FRONT PHARMACEUTICAL PLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE .51; .0035; 1; .01 g/100g; g/100g; g/100g; g/100g N 20181231 69571-008_46c0e6b7-6aea-4c14-bf07-19764126bba5 69571-008 HUMAN OTC DRUG Family Wellness BACITRACIN ZINC OINTMENT TOPICAL 20170613 OTC MONOGRAPH FINAL part333B FRONT PHARMACEUTICAL PLC BACITRACIN ZINC .51 g/100g N 20181231 69571-009_4f0f40b8-2c5d-48a8-83a6-e1aa6c102923 69571-009 HUMAN OTC DRUG Family Wellness HYDROCORTISONE 1% CREAM TOPICAL 20170618 OTC MONOGRAPH NOT FINAL part348 FRONT PHARMACEUTICAL PLC HYDROCORTISONE 1 g/100g N 20181231 69573-888_10162a50-f00b-4426-e054-00144ff88e88 69573-888 HUMAN OTC DRUG Chitoprex 101 38 Biotech Laboratory LLC CAPSULE DENTAL; INTRAOCULAR; INTRATUMOR; INTRAVENOUS; IRRIGATION; NASAL; ORAL; PERIODONTAL; RECTAL; SUBLINGUAL; TOPICAL; TRANSDERMAL; URETERAL; VAGINAL 20150227 UNAPPROVED HOMEOPATHIC 38 Biotech Laboratory LLC CHITOSAN OLIGOSACCHARIDE 250 mg/250mg E 20171231 69574-005_177bbcf8-cd80-506c-e054-00144ff88e88 69574-005 HUMAN OTC DRUG Novum APR Menthol SPRAY TOPICAL 20150519 OTC MONOGRAPH NOT FINAL part348 Novum Solutions Inc MENTHOL .5 g/100mL N 20181231 69578-466_a76170c6-a407-45d4-b461-424bf04b5736 69578-466 HUMAN OTC DRUG CurX Antimicrobial Gel BENZALKONIUM CHLORIDE GEL TOPICAL 20151028 OTC MONOGRAPH NOT FINAL part333A Global Health Solutions, LLC BENZALKONIUM CHLORIDE .13 g/100g E 20171231 69578-466_de59e4bd-ddf4-4364-ae57-f1be831a3f81 69578-466 HUMAN OTC DRUG CurX Antimicrobial Gel benzalkonium chloride GEL TOPICAL 20151028 OTC MONOGRAPH NOT FINAL part333A Global Health Solutions, LLC BENZALKONIUM CHLORIDE .13 g/100g E 20171231 69579-101_caf0d216-4795-4328-852b-f1a047a6b293 69579-101 HUMAN OTC DRUG P1P Mela Care Niacinamide, Panthenol LIQUID TOPICAL 20150126 UNAPPROVED DRUG OTHER Phytos Co., Ltd. NIACINAMIDE; PANTHENOL .025; .01 1/30mL; 1/30mL E 20171231 69579-102_7262f731-9222-48eb-9d26-1a381091e82d 69579-102 HUMAN OTC DRUG P1P Chitosan V-mask Niacinamide, Adenosine PATCH TOPICAL 20150126 UNAPPROVED DRUG OTHER Phytos Co., Ltd. NIACINAMIDE; ADENOSINE; PANTHENOL .025; .0004; .006 1/25mL; 1/25mL; 1/25mL E 20171231 69579-103_42a365db-1d93-435c-b585-41a0783a8e31 69579-103 HUMAN OTC DRUG P1P Skin Rebirth Cream Dimethicone, Adenosine CREAM TOPICAL 20150126 UNAPPROVED DRUG OTHER Phytos Co., Ltd. DIMETHICONE; ADENOSINE .01; .004 1/30mL; 1/30mL E 20171231 69579-104_b8299e0c-82e3-4512-a057-c23ee6fe4421 69579-104 HUMAN OTC DRUG P1P Magic Whitening Antiaging Niacinamide, Panthenol, Adenosine LIQUID TOPICAL 20150126 UNAPPROVED DRUG OTHER Phytos Co., Ltd. NIACINAMIDE; PANTHENOL; ADENOSINE .025; .01; .0004 1/5mL; 1/5mL; 1/5mL E 20171231 69579-105_910682c9-8cd1-4673-a0fe-7cc0bc80aef7 69579-105 HUMAN OTC DRUG P1P Magic Whitening Antiaging Niacinamide, Panthenol, Adenosine LIQUID TOPICAL 20150126 UNAPPROVED DRUG OTHER Phytos Co., Ltd. NIACINAMIDE; PANTHENOL; ADENOSINE .025; .01; .0004 1/30mL; 1/30mL; 1/30mL E 20171231 69579-106_0049b31f-7dc5-4374-9fbd-6ca21dacd174 69579-106 HUMAN OTC DRUG Phytopecia Hair Tonic Panthenol, Niacinamide, Salicylic Acid LIQUID TOPICAL 20151218 UNAPPROVED DRUG OTHER Phytos Co., Ltd. PANTHENOL; NIACINAMIDE; BIOTIN .01; .005; .0001 1/60mL; 1/60mL; 1/60mL E 20171231 69579-107_bf06bab3-2ae5-4173-9703-c6e61c201dc3 69579-107 HUMAN OTC DRUG Phytopecia Hair Boosting Panthenol, Niacinamide SHAMPOO TOPICAL 20151218 UNAPPROVED DRUG OTHER Phytos Co., Ltd. PANTHENOL; NIACINAMIDE .005; .0001 1/250mL; 1/250mL E 20171231 69579-108_140fe2da-993e-4805-a43a-4945459cdd0d 69579-108 HUMAN OTC DRUG P1P AC Repair Ampoule Niacinamide, Salicylic acid,Phytosphingosine LIQUID TOPICAL 20160107 UNAPPROVED DRUG OTHER Phytos Co., Ltd. NIACINAMIDE; SALICYLIC ACID; PHYTOSPHINGOSINE .02; .003; .001 1/30mL; 1/30mL; 1/30mL E 20171231 69580-060_2ecc0d68-4a96-2c44-e054-00144ff88e88 69580-060 HUMAN OTC DRUG Organic Lavender Hand Sanitizer Alcohol Gel LIQUID TOPICAL 20150130 OTC MONOGRAPH NOT FINAL part333A Royal Labs Natural Cosmetics, Inc ALCOHOL 60 mL/100mL E 20171231 69582-590_616f96b9-4390-f9d4-e053-2a91aa0a998f 69582-590 HUMAN OTC DRUG Aurorae Healing Pain Relieving Roll-On MENTHOL SOLUTION TOPICAL 20150204 OTC MONOGRAPH NOT FINAL part348 Ingui Design, LLC MENTHOL 100 mg/mL N 20181231 69583-002_25733a96-bfee-106d-e054-00144ff88e88 69583-002 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20151112 OTC MONOGRAPH NOT FINAL part333E Fun Zone, Inc. ALCOHOL 62 mL/100mL N 20181231 69583-003_48da4daf-a60b-2c5d-e054-00144ff88e88 69583-003 HUMAN OTC DRUG Anti-Bacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20151112 OTC MONOGRAPH NOT FINAL part333E Fun Zone, Inc. ALCOHOL 63 mL/100mL N 20181231 69584-012_308997af-d4b9-49ad-8f12-66903434e3a8 69584-012 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20180125 OTC MONOGRAPH NOT FINAL part343 Oxford Pharmaceuticals, LLC ACETAMINOPHEN 500 mg/1 N 20191231 69584-148_d87716a8-936d-4319-b54f-f36e1e103037 69584-148 HUMAN PRESCRIPTION DRUG Cyclobenzaprine HCl Cyclobenzaprine HCl TABLET, FILM COATED ORAL 20180125 ANDA ANDA077209 Oxford Pharmaceuticals, LLC CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 69584-149_d87716a8-936d-4319-b54f-f36e1e103037 69584-149 HUMAN PRESCRIPTION DRUG Cyclobenzaprine HCl Cyclobenzaprine HCl TABLET, FILM COATED ORAL 20180125 ANDA ANDA077209 Oxford Pharmaceuticals, LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 69587-001_0ec2d4d1-b296-18dc-e054-00144ff88e88 69587-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20150228 ANDA ANDA204472 MIPS Cyclotron & Radiochemistry Facility FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 69592-001_4fef7bc1-f035-46bd-b46f-b4d305f614e7 69592-001 HUMAN PRESCRIPTION DRUG Soothee Patch LIDOCAINE, MENTHOL, CAPSAICIN, METHYL SALICYLATE PATCH TOPICAL 20140316 UNAPPROVED DRUG OTHER Better Pain Solutions, LLC LIDOCAINE; MENTHOL; CAPSAICIN; METHYL SALICYLATE .5; 5; .0375; 2 mg/10g; mg/10g; g/10g; g/10g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 69594-001_990d6070-e695-4011-8e1f-c4857db460ee 69594-001 HUMAN OTC DRUG Out Back Pain Relief Eucalyptus Oil and Tea Tree Oil OIL TOPICAL 20150216 UNAPPROVED DRUG OTHER Ultra Mix (Aust) Pty Ltd EUCALYPTUS OIL; TEA TREE OIL 38.6; 42.5 mg/mL; mg/mL N 20181231 69594-002_46ac3eda-81c1-49e8-82c1-d01c9b6a09c8 69594-002 HUMAN OTC DRUG Elmore Oil Eucalyptus Oil and Tea Tree Oil OIL TOPICAL 20150216 UNAPPROVED DRUG OTHER Ultra Mix (Aust) Pty Ltd EUCALYPTUS OIL; TEA TREE OIL 38.6; 42.5 mg/mL; mg/mL N 20181231 69594-003_a426dd55-6c88-40c1-87cb-e98c9cc3cc53 69594-003 HUMAN OTC DRUG Muscle and Joint Heat Cream Eucalyptus Oil and Tea Tree Oil CREAM TOPICAL 20150216 UNAPPROVED DRUG OTHER Ultra Mix (Aust) Pty Ltd EUCALYPTUS OIL; TEA TREE OIL; METHYL SALICYLATE 38.6; 42.5; 50 mg/g; mg/g; mg/g N 20181231 69594-004_412d447f-56dc-4f62-8e5d-e4ce38bd0de8 69594-004 HUMAN PRESCRIPTION DRUG Original Pain Relief Cream Eucalyptus Oil and Tea Tree Oil CREAM TOPICAL 20150216 UNAPPROVED DRUG OTHER Ultra Mix (Aust) Pty Ltd EUCALYPTUS OIL; TEA TREE OIL 38.6; 42.5 mg/g; mg/g N 20181231 69594-005_f7473b9a-663a-4b24-b603-69f765faa818 69594-005 HUMAN OTC DRUG Outback 2 in 1 Protection OCTINOXATE,AVOBENZONE and ZINC OXIDE CREAM TOPICAL 20150216 OTC MONOGRAPH FINAL part352 Ultra Mix (Aust) Pty Ltd OCTINOXATE; AVOBENZONE; ZINC OXIDE 75; 13; 95 mg/mL; mg/mL; mg/mL N 20181231 69602-1001_e42dab41-1bb0-4de1-bbc0-79a800d7f9ba 69602-1001 HUMAN OTC DRUG CAMELIA BODY GLYCERIN LOTION TOPICAL 20150308 OTC MONOGRAPH FINAL part347 Saebyuck Corp. GLYCERIN 2 g/100mL E 20171231 69602-2001_f108eab3-ecc1-4772-94d8-921bf6ab630b 69602-2001 HUMAN OTC DRUG KOREAN CYPRESS HAIR GLYCERIN SHAMPOO TOPICAL 20150308 OTC MONOGRAPH FINAL part347 Saebyuck Corp. GLYCERIN 4 g/100mL E 20171231 69603-0101_6054b043-2b82-4e8f-b1a7-662eeac60b3d 69603-0101 HUMAN OTC DRUG SELLA CLASSIC NATURAL CLEANSING BAR GLYCERIN SOAP TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Sella Natural Cosmetics Co.,Ltd. GLYCERIN .5 g/100g E 20171231 69603-0201_d5ed8cab-384f-4eb3-ac51-d6824325950f 69603-0201 HUMAN OTC DRUG SELLA CLASSIC NATURAL GOLD SERUM GLYCERIN LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Sella Natural Cosmetics Co.,Ltd. GLYCERIN 4 g/100mL E 20171231 69603-0301_4d294234-5d83-42ba-9561-ad3dfaa27a35 69603-0301 HUMAN OTC DRUG SELLA CLASSIC NATURAL FACIAL ESSENCE ALLANTOIN CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Sella Natural Cosmetics Co.,Ltd. ALLANTOIN .2 g/100mL E 20171231 69603-0401_d24e7c81-e8e4-4feb-88de-6a456064fb4e 69603-0401 HUMAN OTC DRUG SELLA PREMIUM NATURAL CLEANSING BAR GLYCERIN SOAP TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Sella Natural Cosmetics Co.,Ltd. GLYCERIN .4 g/100g E 20171231 69603-0501_08944443-29e7-4e46-9d80-2e94303a3898 69603-0501 HUMAN OTC DRUG SELLA PREMIUM NATURAL GOLD SERUM ALLANTOIN LIQUID TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Sella Natural Cosmetics Co.,Ltd. ALLANTOIN .02 g/100mL E 20171231 69603-0601_a9a54f4b-e7a2-430b-af29-783ea8628c93 69603-0601 HUMAN OTC DRUG SELLA PREMIUM NATURAL FACIAL ESSENCE ALLANTOIN CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Sella Natural Cosmetics Co.,Ltd. ALLANTOIN .02 g/100mL E 20171231 69603-0701_686519d4-222e-4583-a0ec-c735fc00e628 69603-0701 HUMAN OTC DRUG SELLA NATURAL BABY GLYCERIN SOAP TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Sella Natural Cosmetics Co.,Ltd. GLYCERIN .5 g/100g E 20171231 69603-0801_36f1cee4-1fa7-48aa-9a31-b2000ecd59e8 69603-0801 HUMAN OTC DRUG SELLA NATURAL BABY GLYCERIN LOTION TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Sella Natural Cosmetics Co.,Ltd. GLYCERIN .4 g/100mL E 20171231 69603-0901_31181741-a145-49f8-a4fb-8e412576137f 69603-0901 HUMAN OTC DRUG SELLA NATURAL BABY GLYCERIN CREAM TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Sella Natural Cosmetics Co.,Ltd. GLYCERIN 6 g/100mL E 20171231 69603-1001_834a8dc4-6eb7-4a40-b4c7-e9d0f06cebdb 69603-1001 HUMAN OTC DRUG SELLA NATURAL BODY GLYCERIN SOAP TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Sella Natural Cosmetics Co.,Ltd. GLYCERIN .4 g/100g E 20171231 69603-1101_260a55e0-1693-4fe7-acdd-f32b6b0cbdda 69603-1101 HUMAN OTC DRUG SELLA NATURAL BODY ALLANTOIN EMULSION TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Sella Natural Cosmetics Co.,Ltd. ALLANTOIN .02 g/100mL E 20171231 69603-1201_65434457-5894-4411-b6ae-e442f5411bba 69603-1201 HUMAN OTC DRUG SELLA NATURAL HAIR GLYCERIN SOAP TOPICAL 20141201 OTC MONOGRAPH FINAL part347 Sella Natural Cosmetics Co.,Ltd. GLYCERIN .4 g/100g E 20171231 69603-1301_a18434ad-141c-4b85-8637-080bbc7f5ee6 69603-1301 HUMAN OTC DRUG SELLA NATURAL VOLCANIC ASH MUD MASK SILANOL POWDER TOPICAL 20150211 UNAPPROVED DRUG OTHER Sella Natural Cosmetics Co.,Ltd. SILANOL 34.1 g/100g E 20171231 69603-1401_3b208ff4-a566-41a0-8010-cf888a08170f 69603-1401 HUMAN OTC DRUG SELLA NATURAL MENTHOL PASTE, DENTIFRICE TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part356 Sella Natural Cosmetics Co.,Ltd. MENTHOL .2 g/100g E 20171231 69604-204_6ff70900-99e5-11e6-bdf4-0800200c9a66 69604-204 HUMAN PRESCRIPTION DRUG Anthim obiltoxaximab SOLUTION INTRAVENOUS 20160318 BLA BLA125509 Elusys Therapeutics, Inc. OBILTOXAXIMAB 100 mg/mL Anthrax Protective Antigen-directed Antibody [EPC],Anthrax Protective Antigen-directed Antibody Interactions [MoA] N 20181231 69607-0001_f3c885e6-71c5-45e6-82cf-e1ff2799a9e4 69607-0001 HUMAN OTC DRUG Acne Anthracinum, Antimonium crudum, Hydrocotyle asiatica, Juglans regia, Kali bromatum, Ledum palustre, Natrum sulphuratum, Pyrogenium, Radium bromatum, Sanguinaria canadensis, Sulphur iodatum, Thuja occidentalis, Uritica urens SPRAY ORAL 20150707 UNAPPROVED HOMEOPATHIC Biovea BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ANTIMONY TRISULFIDE; CENTELLA ASIATICA; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; POTASSIUM BROMIDE; LEDUM PALUSTRE TWIG; SODIUM SULFIDE NONAHYDRATE; RANCID BEEF; RADIUM BROMIDE; SANGUINARIA CANADENSIS ROOT; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 200; 30; 30; 6; 6; 30; 6; 200; 30; 200; 3; 200; 200; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 69607-0002_845d752f-023a-421a-b5f9-80416d8c2c08 69607-0002 HUMAN OTC DRUG Insomnia Aquilegia Vulgaris, Avena Sativa, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Humulus Lupulus, Hypericum Perforatum, Kali Phosphoricum, Melatonin, Melissa Officinalis, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis LIQUID ORAL 20150702 UNAPPROVED HOMEOPATHIC Biovea AQUILEGIA VULGARIS; AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HOPS; HYPERICUM PERFORATUM; POTASSIUM PHOSPHATE, DIBASIC; MELATONIN; MELISSA OFFICINALIS; SODIUM CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 2; 2; 2; 6; 3; 3; 6; 12; 6; 3; 30; 2; 2 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69607-0003_08964948-e5ea-44c3-9ec9-ac9ace1e0426 69607-0003 HUMAN OTC DRUG Hemorrhoid Relief Aesculus hippocastanum, Arnica montana, Calcarea fluorica, Carduus marianus, Collinsonia canadensis, Hamamelis virginiana, Muriaticum acidum, Ratanhia, SPRAY ORAL 20150708 UNAPPROVED HOMEOPATHIC Biovea HORSE CHESTNUT; ARNICA MONTANA; CALCIUM FLUORIDE; MILK THISTLE; COLLINSONIA CANADENSIS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROCHLORIC ACID; KRAMERIA LAPPACEA ROOT 1; 3; 9; 1; 3; 3; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69607-0004_cd62d46f-df7e-4099-873d-8d3d9e664901 69607-0004 HUMAN OTC DRUG Tension Heacache Aconitum napellus, Carduus marianus, Coffea cruda, Dioscorea villosa, Gelsemium sempervirens, Gnaphalium polycephalum, Iris versicolor, Passiflora incarnata, Stellaria media, Verbascum thapsus SPRAY ORAL 20150707 UNAPPROVED HOMEOPATHIC Biovea ACONITUM NAPELLUS; MILK THISTLE; ARABICA COFFEE BEAN; DIOSCOREA VILLOSA TUBER; GELSEMIUM SEMPERVIRENS ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; IRIS VERSICOLOR ROOT; PASSIFLORA INCARNATA FLOWERING TOP; STELLARIA MEDIA; VERBASCUM THAPSUS 200; 3; 200; 3; 3; 3; 3; 2; 3; 3 [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69607-0005_3bdd46e4-53b2-4b22-94b9-9931690066d8 69607-0005 HUMAN OTC DRUG Back and Neck Pain Aconitum Napellus, Arnica Montana, Belladonna, Cimicifuga Racemosa, Euphorbium Officinarum, Gelsemium Sempervirens, Gnaphalium Polycephalum, Hypericum Perforatum, Magnesia Phosphorica, Phytolacca Decandra, Ranunculus Bulbosus, Rhus Tox SPRAY ORAL 20150701 UNAPPROVED HOMEOPATHIC Biovea ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BLACK COHOSH; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RANUNCULUS BULBOSUS; TOXICODENDRON PUBESCENS LEAF 200; 200; 6; 6; 6; 6; 30; 200; 10; 3; 30; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 69607-0006_e25368d2-cc81-45fd-bdb5-c9f33bc55029 69607-0006 HUMAN OTC DRUG Anxiety Agnus Castus, Avena Sativa, Cinchona Officinalis, Humulus Lupulus, Hyoscyamus Niger, Ignatia Amara, Passiflora Incarnata, Valeriana Officinalis SPRAY ORAL 20150701 UNAPPROVED HOMEOPATHIC Biovea CHASTE TREE; AVENA SATIVA FLOWERING TOP; CINCHONA OFFICINALIS BARK; HOPS; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN 6; 1; 6; 2; 200; 200; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69607-0007_44cc4d6d-a358-41cd-b9fb-425a470aa699 69607-0007 HUMAN OTC DRUG Sinus Pain Antimonium Tartaricum, Arsenicum Iodatum, Asafoetida, Baptisia Tinctoria, Echinacea (Angustifolia), Eupatorium Perfoliatum, Euphorbia Pilulifera, Hepar Sulphuris Calcareum, Kali Bichromicum, Kreosotum, Lachesis Mutus, Mercurius Iodatus Ruber, Pyrogenium, Silicea, Teucrium Marum SPRAY ORAL 20150819 UNAPPROVED HOMEOPATHIC Biovea ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIIODIDE; ASAFETIDA; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHORBIA HIRTA FLOWERING TOP; CALCIUM SULFIDE; POTASSIUM DICHROMATE; WOOD CREOSOTE; LACHESIS MUTA VENOM; MERCURIC IODIDE; RANCID BEEF; SILICON DIOXIDE; TEUCRIUM MARUM 6; 200; 30; 3; 3; 3; 3; 30; 30; 30; 200; 10; 200; 30; 3 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 69607-0008_306d91ad-a7b6-4590-a00f-d2ef5d797181 69607-0008 HUMAN OTC DRUG Cough and Congestion Antimonium Tartaricum, Arsenicum Album, Arsenicum Iodatum, Arum Triphyllum, Baptisia Tinctoria, Bryonia (Alba), Drosera (Rotundifolia), Echinacea Angustifolia, Eupatorium Perfoliatum, Kali Bromatum, Lung Suis, Mercurius Corrosivus, Sticta Pulmonaria, Sulphur Iodatum, Urtica Urens SPRAY ORAL 20150702 UNAPPROVED HOMEOPATHIC Biovea ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; ARISAEMA TRIPHYLLUM ROOT; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; POTASSIUM BROMIDE; SUS SCROFA LUNG; MERCURIC CHLORIDE; LOBARIA PULMONARIA; SULFUR IODIDE; URTICA URENS 200; 200; 200; 30; 3; 200; 30; 3; 200; 6; 6; 200; 200; 200; 200 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 69607-0009_158d4848-de08-4c94-8b5b-58b223c7fe43 69607-0009 HUMAN OTC DRUG Menopause Agnus Castus, Angelica Sinensis Radix, Apis Mellifica, Aralia Quinquefolia, Arnica Montana, Cimicifuga Racemosa, Galium Aparine, Glycyrrhiza Glabra, Oophorinum Suis, Sepia, Thuja Occidentalis, Viscum Album SPRAY ORAL 20150702 UNAPPROVED HOMEOPATHIC Biovea CHASTE TREE; ANGELICA SINENSIS ROOT; APIS MELLIFERA; AMERICAN GINSENG; ARNICA MONTANA; BLACK COHOSH; GALIUM APARINE; GLYCYRRHIZA GLABRA; SUS SCROFA OVARY; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; VISCUM ALBUM FRUITING TOP 3; 3; 6; 3; 6; 3; 3; 3; 30; 30; 6; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69607-0010_4e5b5dac-f652-46c1-9c31-17b4a36b5d03 69607-0010 HUMAN OTC DRUG Stomach Ache Arsenicum Album, Calcarea Phosphorica, Carbo Animalis, Carbo Vegetabilis, Cinchona Officinalis, Nux Vomica, Ornithogalum Umbellatum, Pyrogenium, Silicea SPRAY ORAL 20150824 UNAPPROVED HOMEOPATHIC Biovea ARSENIC TRIOXIDE; CALCIUM SULFATE ANHYDROUS; CARBO ANIMALIS; ACTIVATED CHARCOAL; CINCHONA OFFICINALIS BARK; STRYCHNOS NUX-VOMICA SEED; ORNITHOGALUM UMBELLATUM; RANCID BEEF; SILICON DIOXIDE 200; 200; 12; 12; 200; 200; 12; 200; 12 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 69607-0011_51c2ae2a-3fcb-4cb1-932b-729796c34d72 69607-0011 HUMAN OTC DRUG Stress and Insomnia Avena Sativa, Chamomilla , Humulus Lupulus, Passiflora Incarnata TABLET ORAL 20150706 UNAPPROVED HOMEOPATHIC Biovea AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; HOPS; PASSIFLORA INCARNATA FLOWERING TOP 3; 3; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69607-0012_ca7aa73e-b9d2-448d-b4bd-ad15dbce592e 69607-0012 HUMAN OTC DRUG Acne Anthracinum, Antimonium Crudum, Hydrocotyle Asiatica, Juglans Regia, Kali Bromatum, Ledum Palustre, Natrum Sulphuricum, Pyrogenium, Radium Bromatum, Sanguinaria Canadensis, Sulphur Iodatum, Thuja Occidentalis, Urtica Urens SPRAY ORAL 20150813 UNAPPROVED HOMEOPATHIC Biovea BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; ANTIMONY TRISULFIDE; CENTELLA ASIATICA; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; POTASSIUM BROMIDE; LEDUM PALUSTRE TWIG; SODIUM SULFATE; RANCID BEEF; RADIUM BROMIDE; SANGUINARIA CANADENSIS ROOT; SULFUR IODIDE; THUJA OCCIDENTALIS LEAFY TWIG; URTICA URENS 200; 30; 30; 6; 6; 30; 6; 200; 30; 200; 3; 200; 200; 3 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 69612-622_4d7393c5-a7b5-4618-e054-00144ff88e88 69612-622 HUMAN OTC DRUG Hydrogen Peroxide 3 Topical HYDROGEN PEROXIDE LIQUID TOPICAL 20170418 OTC MONOGRAPH NOT FINAL part333A RW Consumer Products Ltd HYDROGEN PEROXIDE 30 mg/mL N 20181231 69612-623_4d7393c5-a7cc-4618-e054-00144ff88e88 69612-623 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 70 ISOPROPYL ALCOHOL LIQUID TOPICAL 20170418 OTC MONOGRAPH NOT FINAL part333A RW Consumer Products Ltd ISOPROPYL ALCOHOL 30 mg/mL N 20181231 69614-370_47f4d4c4-fb57-5e0e-e054-00144ff8d46c 69614-370 HUMAN OTC DRUG ENDURE Male Genital Desensitizing LIDOCAINE HYDROCHLORIDE SPRAY TOPICAL 20150218 OTC MONOGRAPH FINAL part348 Endure Holdings, LLC LIDOCAINE 10 mg/100mL N 20181231 69615-001_6199ad50-40b6-4fee-e053-2991aa0aaf5e 69615-001 HUMAN OTC DRUG Clean Energy Patch caffeine patch PATCH TOPICAL 20150213 UNAPPROVED HOMEOPATHIC XEP, Inc. CAFFEINE; PAULLINIA CUPANA SEED; COCOA 1; 1; 1 [hp_X]/1.5g; [hp_X]/1.5g; [hp_X]/1.5g N 20181231 69618-010_25626b46-78f9-7226-e054-00144ff8d46c 69618-010 HUMAN OTC DRUG ACETAMINOPHEN 325 MG ACETAMINOPHEN TABLET ORAL 20151101 OTC MONOGRAPH NOT FINAL part343 Reliable 1 Laboratories LLC ACETAMINOPHEN 325 mg/1 N 20181231 69618-011_2651bf11-4d67-43ba-e054-00144ff88e88 69618-011 HUMAN OTC DRUG ACETAMINOPHEN 500 MG ACETAMINOPHEN TABLET ORAL 20151101 OTC MONOGRAPH NOT FINAL part343 Reliable 1 Laboratories LLC ACETAMINOPHEN 500 mg/1 N 20181231 69618-012_2707806f-8de5-4a2c-e054-00144ff8d46c 69618-012 HUMAN OTC DRUG ACETAMINOPHEN 80 MG FRUIT CHEW ACETAMINOPHEN TABLET ORAL 20151101 OTC MONOGRAPH NOT FINAL part343 Reliable 1 Laboratories LLC ACETAMINOPHEN 80 mg/1 N 20181231 69618-013_2a6a0775-b2c6-5385-e054-00144ff88e88 69618-013 HUMAN OTC DRUG ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG ACETAMINOPHEN / DIPHENHYDRAMINE TABLET ORAL 20151101 OTC MONOGRAPH NOT FINAL part343 Reliable 1 Laboratories LLC DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN 25; 500 mg/1; mg/1 N 20181231 69618-014_2e3095a3-99fc-183f-e054-00144ff88e88 69618-014 HUMAN OTC DRUG Aspirin 81 mg Aspirin TABLET, CHEWABLE ORAL 20151101 OTC MONOGRAPH FINAL part343 Reliable 1 Laboratories LLC ASPIRIN 81 mg/1 N 20181231 69618-015_2ab8564f-f959-7512-e054-00144ff88e88 69618-015 HUMAN OTC DRUG ASPIRIN 325 MG EC ASPIRIN TABLET ORAL 20151101 OTC MONOGRAPH FINAL part343 Reliable 1 Laboratories LLC ASPIRIN 325 mg/1 N 20181231 69618-016_2ab9c1a6-e0b4-1098-e054-00144ff8d46c 69618-016 HUMAN OTC DRUG ASPIRIN 325 MG ASPIRIN TABLET ORAL 20151101 OTC MONOGRAPH NOT FINAL part343 Reliable 1 Laboratories LLC ASPIRIN 325 mg/1 N 20181231 69618-017_2c75dadc-a7d4-0b6a-e054-00144ff8d46c 69618-017 HUMAN OTC DRUG Aspirin 81 mg Enteric Coated Aspirin TABLET ORAL 20151101 OTC MONOGRAPH FINAL part343 Reliable 1 Laboratories LLC ASPIRIN 81 mg/1 N 20181231 69618-020_322f1b54-abea-11a7-e054-00144ff8d46c 69618-020 HUMAN OTC DRUG Calcium Carbonate 500 mg Calcium Carbonate TABLET, CHEWABLE ORAL 20151101 OTC MONOGRAPH FINAL part331 Reliable 1 Laboratories LLC CALCIUM CARBONATE 500 mg/1 N 20181231 69618-021_32bc07dc-7a95-63ed-e054-00144ff8d46c 69618-021 HUMAN OTC DRUG Calsium Carbonate 10 gr Calcium Carbonate TABLET ORAL 20151101 OTC MONOGRAPH FINAL part331 Reliable 1 Laboratories LLC CALCIUM CARBONATE 648 mg/1 N 20181231 69618-022_31dec627-f2e5-6dbe-e054-00144ff8d46c 69618-022 HUMAN OTC DRUG Chlorpheniramine Maleate 4 mg Chlorpheniramine Maleate TABLET ORAL 20151101 OTC MONOGRAPH FINAL part341 Reliable 1 Laboratories LLC CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 69618-024_32fa40ad-fed6-586f-e054-00144ff88e88 69618-024 HUMAN OTC DRUG Diphenhydramine HCl 25 mg Diphenhydramine HCl CAPSULE ORAL 20151101 OTC MONOGRAPH FINAL part341 Reliable 1 Laboratories LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69618-025_32fab4b2-31a4-6c31-e054-00144ff88e88 69618-025 HUMAN OTC DRUG Diphenhydramine HCL 25 mg Diphenhydramine HCL TABLET ORAL 20151101 OTC MONOGRAPH FINAL part341 Reliable 1 Laboratories LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69618-027_32832b0f-0b39-27ce-e054-00144ff8d46c 69618-027 HUMAN OTC DRUG Meclizine HCL 12.5 mg Meclizine HCL 12.5 mg TABLET ORAL 20151101 OTC MONOGRAPH FINAL part336 Reliable 1 Laboratories LLC MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20181231 69618-028_32bdd802-16b1-184d-e054-00144ff88e88 69618-028 HUMAN OTC DRUG Meclizine HCL 25 mg Meclizine HCL TABLET ORAL 20151101 OTC MONOGRAPH FINAL part336 Reliable 1 Laboratories LLC MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 69618-029_2e40ffd8-1afb-43af-e054-00144ff8d46c 69618-029 HUMAN OTC DRUG Bismuth Subsalicylate 262 mg Bismuth Subsalicylate TABLET, CHEWABLE ORAL 20151101 OTC MONOGRAPH FINAL part335 Reliable 1 Laboratories LLC BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 69618-030_2fabd7ec-2290-1565-e054-00144ff88e88 69618-030 HUMAN OTC DRUG Calcium Polycarbophil 625 mg Calcium Polycarbophil 625 mg TABLET ORAL 20151101 OTC MONOGRAPH NOT FINAL part334 Reliable 1 Laboratories LLC CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 69618-032_330aed4b-710a-09b8-e054-00144ff8d46c 69618-032 HUMAN OTC DRUG Simethicone 125 mg Simethicone TABLET, CHEWABLE ORAL 20151101 OTC MONOGRAPH FINAL part332 Reliable 1 Laboratires LLC DIMETHICONE 125 mg/1 N 20181231 69618-033_32fb242b-7052-072c-e054-00144ff88e88 69618-033 HUMAN OTC DRUG Simethicone 80 mg Simethicone TABLET, CHEWABLE ORAL 20151101 OTC MONOGRAPH FINAL part332 Reliable 1 Laboratories LLC DIMETHICONE 80 mg/1 N 20181231 69618-034_321a772c-c44d-3d4e-e054-00144ff8d46c 69618-034 HUMAN OTC DRUG Sodium Bicarbonate 10 gr Sodium Bicarbonate TABLET ORAL 20151101 OTC MONOGRAPH NOT FINAL part334 Reliable 1 Laboratories LLC SODIUM BICARBONATE 648 mg/1 N 20181231 69618-035_31e090e9-5422-4b45-e054-00144ff8d46c 69618-035 HUMAN OTC DRUG Sodium Bicarbonate 5 gr Sodium Bicarbonate TABLET ORAL 20151101 OTC MONOGRAPH NOT FINAL part334 Reliable 1 Laboratories LLC SODIUM BICARBONATE 324 mg/1 N 20181231 69618-043_383ce892-de64-62e8-e054-00144ff88e88 69618-043 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20160401 OTC MONOGRAPH NOT FINAL part334 Reliable 1 Laboratories LLC DOCUSATE SODIUM 100 mg/1 N 20181231 69618-044_597bab7a-3b63-1083-e053-2a91aa0a9d48 69618-044 HUMAN OTC DRUG Docusate Sodium Docusate Sodium CAPSULE ORAL 20170301 OTC MONOGRAPH NOT FINAL part334 Reliable-1 Laboratories LLC DOCUSATE SODIUM 100 mg/1 N 20181231 69618-045_78fed69f-82c1-48d2-a323-0c0144246e20 69618-045 HUMAN OTC DRUG Ultra Strength Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20170713 OTC MONOGRAPH FINAL part332 RELIABLE 1 LABORATORIES LLC DIMETHICONE 180 mg/1 N 20181231 69618-047_5bfea5f5-898f-4ddb-e053-2a91aa0af2f4 69618-047 HUMAN OTC DRUG Omeprazole Omeprazole CAPSULE ORAL 20170816 ANDA ANDA078878 Reliable 1 Laboratories LLC OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 69619-303_f81e17ac-17ff-4313-b7fa-88bba0d02367 69619-303 HUMAN OTC DRUG Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI CAPSULE, LIQUID FILLED ORAL 20160324 OTC MONOGRAPH FINAL part341 A&Z Holistic Products, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 69621-090_ac948f39-89b1-49d3-9706-30df30a5782f 69621-090 HUMAN PRESCRIPTION DRUG Folixapure Folic Acid, Vitamin D3 TABLET ORAL 20160513 UNAPPROVED DRUG OTHER Shoreline Pharmaceuticals, Inc. FOLIC ACID; VITAMIN D 1; 125 mg/1; ug/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20181231 69621-093_2381f1a9-cb94-44bf-8897-393e2756eb90 69621-093 HUMAN PRESCRIPTION DRUG Xenaflamm diclofenac sodium, capsaicin KIT 20160517 ANDA ANDA075185 Shoreline Pharmaceuticals, Inc. N 20181231 69621-300_2db8f138-1910-179e-e054-00144ff8d46c 69621-300 HUMAN PRESCRIPTION DRUG Diclofenac Sodium 3% Diclofenac Spray AEROSOL, METERED TOPICAL 20160107 UNAPPROVED DRUG OTHER Shoreline Pharmaceuticals, Inc. DICLOFENAC SODIUM 30 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 69621-343_4a55f7b2-dec1-416d-8fe0-ea25c1f64b30 69621-343 HUMAN PRESCRIPTION DRUG Xelitral diclofenac sodium, capsaicin KIT 20160510 ANDA ANDA202769 Shoreline Pharmaceuticals, Inc. N 20181231 69621-365_054ab420-32ab-4237-b640-abada8896e9c 69621-365 HUMAN PRESCRIPTION DRUG Lexixryl Diclofenac Sodium KIT 20161108 ANDA ANDA202769 Shoreline Pharmaceuticals, Inc. N 20181231 69621-371_7738c318-f5f9-4d7f-8fa3-4211071dabc1 69621-371 HUMAN PRESCRIPTION DRUG Lidocaine HCl 3.88% Lidocaine Hydrochloride CREAM TOPICAL 20170803 UNAPPROVED DRUG OTHER Shoreline Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE 38.8 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 69621-392_5cb42291-1786-4b26-a292-acd985fa4a4a 69621-392 HUMAN PRESCRIPTION DRUG Ticaspray Fluticasone Propionate KIT 20160510 ANDA ANDA077538 Shoreline Pharmaceuticals, Inc. N 20181231 69621-393_aaa793a8-a6b4-4759-918f-3664c4213fc5 69621-393 HUMAN PRESCRIPTION DRUG Dermazone Triamcinolone Acetonide KIT 20160420 ANDA ANDA088042 Shoreline Pharmaceuticals, Inc. N 20181231 69621-394_c0071046-e93b-40b2-b7ba-6cce7b1f34de 69621-394 HUMAN PRESCRIPTION DRUG Tri-Sila Triamcinolone Acetonide, Dimethicone KIT 20160511 ANDA ANDA088042 Shoreline Pharmaceuticals, Inc. N 20181231 69621-707_23a932ee-9371-4242-a3be-ac6207141d9f 69621-707 HUMAN PRESCRIPTION DRUG TriXylitral Diclofenac Sodium, Lidocaine Hydrochloride KIT 20180115 ANDA ANDA202769 Shoreline Pharmaceuticals N 20191231 69621-810_f070e3bb-63ae-4221-b780-15b42502b00b 69621-810 HUMAN PRESCRIPTION DRUG Prikaan Lite lidocaine and prilocaine KIT 20160914 NDA AUTHORIZED GENERIC NDA019941 Shoreline Pharmaceuticals, Inc. N 20181231 69621-811_3d1d46cc-7a96-1e5d-e054-00144ff8d46c 69621-811 HUMAN PRESCRIPTION DRUG Lidotrans 5 Pak Lidocaine KIT TOPICAL 20160916 ANDA ANDA205318 Shoreline Pharmaceuticals, Inc. N 20181231 69621-812_46027a67-5cfa-4caf-9f46-75b074662d61 69621-812 HUMAN PRESCRIPTION DRUG Ticalast azelastine hydrochloride and fluticasone propionate KIT 20160928 NDA NDA202236 Shoreline Pharmaceuticals, Inc. N 20181231 69621-813_3d0ea4e5-d01a-1da7-e054-00144ff8d46c 69621-813 HUMAN PRESCRIPTION DRUG Diclo Gel 1% Pak diclofenac sodium, isopropyl alcohol KIT 20160920 NDA NDA022122 Shoreline Pharmaceuticals, Inc. N 20181231 69621-814_0ff2f995-1482-4d82-bb02-e7b9c83f4c05 69621-814 HUMAN PRESCRIPTION DRUG Diclo Gel 1% with Xrylix Sheets diclofenac sodium KIT 20160922 NDA NDA022122 Shoreline Pharmaceuticals, Inc. N 20181231 69621-821_dfa240db-ef4b-4d10-8196-ac578e47ce15 69621-821 HUMAN PRESCRIPTION DRUG Zeyocaine lidocaine, isopropyl alcohol KIT TOPICAL 20160930 ANDA ANDA205318 Shoreline Pharmaceuticals, Inc. N 20181231 69621-828_3531dd4f-a009-47bd-b3d5-12c786136a54 69621-828 HUMAN PRESCRIPTION DRUG Prikaan lidocaine and prilocaine KIT 20160908 NDA AUTHORIZED GENERIC NDA019941 Shoreline Pharmaceuticals, Inc. N 20181231 69621-841_50cd763d-3bc9-4a75-828a-c57cba101c73 69621-841 HUMAN PRESCRIPTION DRUG SilaLite Pak triamcinolone acetonide KIT 20161205 ANDA ANDA205373 Shoreline Pharmaceuticals, Inc. N 20181231 69621-846_9db9f00e-236f-4198-882f-412c8016ad24 69621-846 HUMAN PRESCRIPTION DRUG Yaliira Pak triamcinolone acetonide, dimethicone KIT 20161229 ANDA ANDA205373 Shoreline Pharmaceuticals, Inc. N 20181231 69621-873_3ce24b80-017f-0fdb-e054-00144ff88e88 69621-873 HUMAN PRESCRIPTION DRUG DermacinRx Prikaan lidocaine and prilocaine KIT 20160701 NDA AUTHORIZED GENERIC NDA019941 Shoreline Pharmaceuticals, Inc. N 20181231 69625-018_89b60a36-2018-4884-8956-a63dfbe60281 69625-018 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Body Broad Spectrum SPF 50 Ultra Light Sunscreen Titanium Dioxide LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Cosmetique Active Production TITANIUM DIOXIDE 110 mg/mL N 20181231 69625-899_35b668b3-b7c0-443c-8301-bc1ac3952d38 69625-899 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50 Titanium Dioxide LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Cosmetique Active Production TITANIUM DIOXIDE 110 mg/mL N 20181231 69625-907_dfb96d31-8c17-42b1-97d4-172406998a5b 69625-907 HUMAN OTC DRUG La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Sunscreen Face Broad Spectrum SPF 50 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part352 Cosmetique Active Production TITANIUM DIOXIDE; ZINC OXIDE 60; 50 mg/mL; mg/mL N 20181231 69626-0047_5f21694c-d1ca-0e64-e053-2a91aa0a0ff0 69626-0047 HUMAN OTC DRUG NICE SORE THROAT Cherry Phenol SPRAY ORAL 20140307 OTC MONOGRAPH NOT FINAL part356 Leosons Overseas Corp PHENOL 1.4 g/100mL N 20181231 69626-0048_5fc68f04-ec16-11c0-e053-2a91aa0a1952 69626-0048 HUMAN OTC DRUG NICE SORE THROAT Spearmint Phenol SPRAY ORAL 20140307 OTC MONOGRAPH NOT FINAL part356 Leosons Overseas Corp PHENOL 1.4 g/177mL N 20181231 69626-0064_4f002b66-f7b7-4959-832f-7c2af4d9629c 69626-0064 HUMAN OTC DRUG Clear Mist Sodium Chloride LIQUID NASAL 20160101 OTC MONOGRAPH FINAL part349 Leosons Overseas Corp SODIUM CHLORIDE 6.5 mg/mL N 20181231 69626-0077_601aea98-e6ac-de6f-e053-2a91aa0a824a 69626-0077 HUMAN OTC DRUG NICE SORE THROAT Honey Lemon Phenol SPRAY ORAL 20140307 OTC MONOGRAPH NOT FINAL part356 Leosons Overseas Corp PHENOL 1.4 g/177mL N 20181231 69626-0084_ef8aaa38-408b-4cc8-8258-4b269f18a7ca 69626-0084 HUMAN OTC DRUG RELIEF SODIUM PHOSPHATE, MONOBASIC and SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE ENEMA RECTAL 20150209 OTC MONOGRAPH NOT FINAL part334 Leosons Overseas Corp SODIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 19; 7 g/133mL; g/133mL N 20181231 69626-5200_6a09a620-44ac-4e43-94ff-710cdd8def62 69626-5200 HUMAN OTC DRUG Gas-Aid Drops for infants simethicone EMULSION ORAL 20150808 OTC MONOGRAPH FINAL part332 Leosons DIMETHICONE 20 mg/.3mL N 20181231 69626-7197_eaccf211-de2c-44e7-8b47-5197a983cbcb 69626-7197 HUMAN OTC DRUG Gas-Aid simethicone TABLET, CHEWABLE ORAL 20150808 OTC MONOGRAPH FINAL part332 Leosons Overseas Corp DIMETHICONE 125 mg/1 N 20181231 69627-112_d11cde63-2276-4fc7-ad87-e696d3aa7a22 69627-112 HUMAN OTC DRUG Ocean Seas Dermatology Acne Treatment Cleanser Benzoyl Peroxide SOLUTION TOPICAL 20160329 OTC MONOGRAPH FINAL part333D Coastal Carolinas Integrated Medicine BENZOYL PEROXIDE 2.5 g/100mL E 20171231 69628-010_54018826-f130-4f8e-9f67-56b850647e8f 69628-010 HUMAN OTC DRUG TENSION NO. 5 WITCH HAZEL CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 Maywell Co., Ltd. WITCH HAZEL .0001 mg/50mL N 20181231 69629-010_30a677f5-a7b7-47b0-962b-24b15369fc54 69629-010 HUMAN OTC DRUG Pure Whitenol Serum Tranexamic Acid CREAM TOPICAL 20150201 UNAPPROVED DRUG OTHER SKIN M.D. KOREA TRANEXAMIC ACID .05 mg/50mL E 20171231 69630-001_5973fb6f-10df-4b7b-9d62-fc7ea4ffb845 69630-001 HUMAN OTC DRUG Soleil Broad Spectrum SPF-15 Octinoxate, Octisalate, Zinc Oxide SPRAY TOPICAL 20150213 OTC MONOGRAPH FINAL part352 The Soleil Group, LLC OCTINOXATE; OCTISALATE; ZINC OXIDE 5; 3; 2.5 mg/mL; mg/mL; mg/mL E 20171231 69630-002_1eab416b-4a69-40c7-a4ac-4be0038572f5 69630-002 HUMAN OTC DRUG Soleil Broad Spectrum SPF-30 Octinoxate, Octisalate, Zinc Oxide SPRAY TOPICAL 20150213 OTC MONOGRAPH FINAL part352 The Soleil Group, LLC OCTINOXATE; OCTISALATE; ZINC OXIDE; AVOBENZONE 7.4; 4; 1.7; 1 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 69630-003_2f80bdd5-a876-401c-8115-516a085a3a3a 69630-003 HUMAN OTC DRUG Soleil Broad Spectrum SPF-50 Octinoxate, Octisalate, Zinc Oxide SPRAY TOPICAL 20150213 OTC MONOGRAPH FINAL part352 The Soleil Group, LLC OCTINOXATE; OCTISALATE; ZINC OXIDE; AVOBENZONE 7.5; 6; 3; 3 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 69630-639_47f5441d-e6d2-0485-e054-00144ff8d46c 69630-639 HUMAN OTC DRUG Soleil Broad Spectrum SPF 30 Sunscreen Body Creme OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150325 OTC MONOGRAPH FINAL part352 Soleil Group, LLC OCTINOXATE; TITANIUM DIOXIDE 75; 35 mg/mL; mg/mL N 20181231 69631-0001_5e15748d-a92f-4ea0-a21f-a58e2424b1ac 69631-0001 HUMAN OTC DRUG Harmony Slumber Avena sativa, Chamomilla, Cypripedium pubescens, Daphne indica, Humulus lupulus, Hyoscyamus niger, kali bromatum, Kali phosphoricum, Lithium muriaticum, Passiflora incarnata, Scutellaria lateriflora, Stramonium, Succinum, Sumbul, Valeriana officinalis, Xanthoxylum fraxineum, Ferrum phosphoricum, Lecithin, Manganum phosphoricum, Arsenicum album, Coffea cruda, Ignatia amara, Nux moschata, agaricus muscarius, Belladonna, Cocculus indicus, Helleborus niger, Jequirity, Melissa officinalis, Viburnum opulus LIQUID ORAL 20151008 UNAPPROVED HOMEOPATHIC Life Harmony Energies, LLC. AVENA SATIVA FLOWERING TOP; MATRICARIA RECUTITA; CYPRIPEDIUM PARVIFOLUM ROOT; DAPHNE ODORA BARK; HOPS; HYOSCYAMUS NIGER; POTASSIUM BROMIDE; POTASSIUM PHOSPHATE, DIBASIC; LITHIUM CHLORIDE; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA; DATURA STRAMONIUM; AMBER; FERULA SUMBUL ROOT; VALERIAN; ZANTHOXYLUM AMERICANUM BARK; FERROSOFERRIC PHOSPHATE; EGG PHOSPHOLIPIDS; MANGANESE PHOSPHATE, DIBASIC; ARSENIC TRIOXIDE; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; NUTMEG; AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; ANAMIRTA COCCULUS SEED; HELLEBORUS NIGER ROOT; ABRUS PRECATORIUS SEED; MELISSA OFFICINALIS; VIBURNUM OPULUS BARK 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 30; 30; 30; 4; 6; 6; 6; 6; 6; 6; 6 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL N 20181231 69633-111_96e6fee5-f4d3-4ed6-8cbf-3341ebcc87ae 69633-111 HUMAN OTC DRUG Medi-Quik First Aid Antiseptic benzalkonium chloride, lidocaine hydrochloride SPRAY, METERED TOPICAL 20140930 OTC MONOGRAPH NOT FINAL part333A Quantum Pharmaceuticals Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE ANHYDROUS .0013; .025 g/g; g/g E 20171231 69634-020_6dbee61d-be1c-4c85-89e2-903c9672c9f2 69634-020 HUMAN OTC DRUG Health-Tec Topical Anesthetic Benzocaine GEL DENTAL 20150401 OTC MONOGRAPH NOT FINAL part356 Dental Health Products, Inc. BENZOCAINE 200 mg/g N 20181231 69634-021_95b2e3ef-36e0-4204-bc45-0d1b764a33db 69634-021 HUMAN OTC DRUG Health-Tec Topical Anesthetic Benzocaine GEL DENTAL 20150401 OTC MONOGRAPH NOT FINAL part356 Dental Health Products, Inc. BENZOCAINE 200 mg/g N 20181231 69634-022_b73bdc7c-49c3-4b95-9410-8524b74f07f2 69634-022 HUMAN OTC DRUG Health-Tec Topical Anesthetic Benzocaine GEL DENTAL 20150401 OTC MONOGRAPH NOT FINAL part356 Dental Health Products, Inc. BENZOCAINE 200 mg/g N 20181231 69634-023_0ce6304c-965b-4f74-ab03-8399ad41f7cb 69634-023 HUMAN OTC DRUG Health-Tec Topical Anesthetic Benzocaine GEL DENTAL 20150401 OTC MONOGRAPH NOT FINAL part356 Dental Health Products, Inc. BENZOCAINE 200 mg/g N 20181231 69634-024_8aabffc1-ea6a-4d36-8d2c-03b987bb598f 69634-024 HUMAN OTC DRUG Health-Tec Topical Anesthetic Benzocaine GEL DENTAL 20150401 OTC MONOGRAPH NOT FINAL part356 Dental Health Products, Inc. BENZOCAINE 200 mg/g N 20181231 69634-025_dde3b2f1-4b9a-4354-a4a5-b50d0a8dc693 69634-025 HUMAN OTC DRUG Health-Tec Topical Anesthetic Benzocaine GEL DENTAL 20150401 OTC MONOGRAPH NOT FINAL part356 Dental Health Products, Inc. BENZOCAINE 200 mg/g N 20181231 69634-026_e8059133-b1ed-4aab-96ea-93183cecd540 69634-026 HUMAN OTC DRUG Health-Tec Topical Anesthetic Benzocaine GEL DENTAL 20150401 OTC MONOGRAPH NOT FINAL part356 Dental Health Products, Inc. BENZOCAINE 200 mg/g N 20181231 69636-3025_2fae7dd2-1d16-0459-e054-00144ff88e88 69636-3025 HUMAN OTC DRUG Lincoln Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate OINTMENT TOPICAL 20130517 OTC MONOGRAPH FINAL part333B Lincoln Pharmaceutical Ltd. POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC 5000; 3.5; 400 [USP'U]/g; mg/g; [USP'U]/g E 20171231 69636-3035_2fb062c7-d75f-4c42-e054-00144ff88e88 69636-3035 HUMAN OTC DRUG Lincoln Bacitracin Zinc OINTMENT TOPICAL 20130530 OTC MONOGRAPH FINAL part333B Lincoln Pharmaceuticals Ltd. BACITRACIN ZINC 500 [USP'U]/g E 20171231 69636-3045_45c37f14-ce77-523c-e054-00144ff88e88 69636-3045 HUMAN OTC DRUG Lincoln white petrolatum OINTMENT TOPICAL 20170110 OTC MONOGRAPH FINAL part347 Lincoln Pharmaceuticals Ltd. PETROLATUM 76 g/100g N 20181231 69636-3050_2fbe9ae0-52d8-298a-e054-00144ff8d46c 69636-3050 HUMAN OTC DRUG Lincoln Hydrocortisone Acetate CREAM TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part348 Lincoln Pharmaceuticals Ltd. HYDROCORTISONE ACETATE .01 g/g E 20171231 69636-3066_45c4d71e-99f9-18ce-e054-00144ff8d46c 69636-3066 HUMAN OTC DRUG Lincoln ZINC OXIDE CREAM TOPICAL 20170110 OTC MONOGRAPH FINAL part347 Lincoln Pharmaceuticals Ltd. ZINC OXIDE 3.8 g/100g N 20181231 69636-8020_3e1f9d2e-c25a-4c42-e054-00144ff88e88 69636-8020 HUMAN OTC DRUG LincoShield Zinc Oxide OINTMENT TOPICAL 20161006 OTC MONOGRAPH FINAL part347 Lincoln Pharmaceuticals Ltd. ZINC OXIDE 3.8 g/100g E 20171231 69636-8050_3e20d989-cc34-2e15-e054-00144ff8d46c 69636-8050 HUMAN OTC DRUG LincoFix Lanolin OINTMENT TOPICAL 20161006 OTC MONOGRAPH FINAL part347 Lincoln Pharmaceuticals Ltd. LANOLIN 22 g/100g E 20171231 69638-050_8a2b6cf1-ef6f-4f41-b88c-34e7f5614cd9 69638-050 HUMAN PRESCRIPTION DRUG Scotts Select APF Sodium Fluoride GEL DENTAL 20131201 UNAPPROVED DRUG OTHER Scott's Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69638-051_6ec56150-080e-441d-847c-e04f673e9490 69638-051 HUMAN PRESCRIPTION DRUG Scotts Select APF Sodium Fluoride GEL DENTAL 20131201 UNAPPROVED DRUG OTHER Scott's Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69638-052_72439182-a891-4820-bef3-9961db65ed5f 69638-052 HUMAN PRESCRIPTION DRUG Scotts Select APF Sodium Fluoride GEL DENTAL 20131201 UNAPPROVED DRUG OTHER Scott's Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69638-053_a6d1e9c3-49d3-4e7a-8d68-ed79151dacfc 69638-053 HUMAN PRESCRIPTION DRUG Scotts Select APF Sodium Fluoride GEL DENTAL 20131201 UNAPPROVED DRUG OTHER Scott's Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69638-054_c26bb714-c56b-4060-ba9b-96f3983495e0 69638-054 HUMAN PRESCRIPTION DRUG Scotts Select APF Sodium Fluoride GEL DENTAL 20131201 UNAPPROVED DRUG OTHER Scott's Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69638-055_f4a4dad1-76e2-484f-b806-66b12fcb7b9c 69638-055 HUMAN PRESCRIPTION DRUG Scotts Select APF Sodium Fluoride GEL DENTAL 20131201 UNAPPROVED DRUG OTHER Scott's Dental Supply, LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69638-056_cac19a20-6f8b-4a5a-9d54-f68d0d927f12 69638-056 HUMAN OTC DRUG Scotts Select Stannous Fluoride GEL DENTAL 20130601 OTC MONOGRAPH FINAL part355 Scott's Dental Supply, LLC STANNOUS FLUORIDE .116 g/120g N 20181231 69638-057_b1b95f15-4fcd-4fad-bd45-6e48a20ebb8f 69638-057 HUMAN PRESCRIPTION DRUG Scotts Neutral pH Sodium Fluoride GEL DENTAL 20141101 UNAPPROVED DRUG OTHER Scott's Dental Supply, LLC SODIUM FLUORIDE 4.086 g/454g N 20181231 69638-058_4ad87715-1c82-4693-bbe1-719b00b995ec 69638-058 HUMAN PRESCRIPTION DRUG Scotts Select Homecare Sodium Fluoride GEL DENTAL 20130601 UNAPPROVED DRUG OTHER Scott's Dental Supply, LLC SODIUM FLUORIDE .597 g/120g E 20171231 69638-059_1426d543-ee44-4f2e-89a4-ab73c7006bf1 69638-059 HUMAN PRESCRIPTION DRUG Scotts Select NEPHRO-stat Aluminum Chloride SOLUTION DENTAL 20130301 UNAPPROVED DRUG OTHER Scott's Dental Supply, LLC ALUMINUM CHLORIDE 7500 mg/30mL N 20181231 69639-101_b92142f8-32ea-428d-8a2e-ce59482b8bd6 69639-101 HUMAN PRESCRIPTION DRUG AKYNZEO Netupitant and Palonosetron CAPSULE ORAL 20141013 NDA NDA205718 Helsinn Therapeutics (U.S.), Inc. NETUPITANT; PALONOSETRON 300; .5 mg/1; mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 69640-1001_c1adf870-0eb9-4e4b-a9bf-c065bd18bde8 69640-1001 HUMAN OTC DRUG DONGINBI RED GINSENG RADIANCE CUSHION BB 21 TITANIUM DIOXIDE POWDER TOPICAL 20150308 OTC MONOGRAPH FINAL part352 KGC Life&Gin Co., Ltd. TITANIUM DIOXIDE 7 g/100g E 20171231 69640-2001_dafa3668-75a1-45a6-9497-b8480d5c0b73 69640-2001 HUMAN OTC DRUG DONGINBI RED GINSENG RADIANCE CUSHION BB 23 TITANIUM DIOXIDE POWDER TOPICAL 20150308 OTC MONOGRAPH FINAL part352 KGC Life&Gin Co., Ltd. TITANIUM DIOXIDE 7 g/100g E 20171231 69640-3001_bae81614-bbbb-420b-9cb3-4873cb395817 69640-3001 HUMAN OTC DRUG DONGINBI Red Ginseng Perfect Sun TITANIUM DIOXIDE CREAM TOPICAL 20150308 OTC MONOGRAPH FINAL part352 KGC Life&Gin Co., Ltd. TITANIUM DIOXIDE 2.905 g/100mL E 20171231 69640-4001_7a1d09d3-7e2d-4434-a00f-fc7eb29cd0ca 69640-4001 HUMAN OTC DRUG DONGINBI Red Ginseng Perfect Sun Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20150308 OTC MONOGRAPH NOT FINAL part352 KGC LIFE&GIN OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 3.75; 2.5; 2.45; 1.45 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 69640-5001_76831efd-72cb-49a1-8449-7ed74c218dc6 69640-5001 HUMAN OTC DRUG DONGINBI RED GINSENG RADIANCE CUSHION BB 21 Octinoxate, Titanium Dioxide, Octisalate POWDER TOPICAL 20150308 OTC MONOGRAPH NOT FINAL part352 KGC LIFE&GIN OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 1.05; .75; 1.88 g/15g; g/15g; g/15g N 20181231 69640-6001_d468472d-0e8c-4cf6-826f-17c8768340f6 69640-6001 HUMAN OTC DRUG DONGINBI RED GINSENG RADIANCE CUSHION BB 23 Octinoxate, Titanium Dioxide, Octisalate POWDER TOPICAL 20150308 OTC MONOGRAPH NOT FINAL part352 KGC LIFE&GIN OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 1.05; .75; 1.88 g/15g; g/15g; g/15g N 20181231 69642-1100_093e1436-8570-41f7-bb03-124a9fc1dc51 69642-1100 HUMAN OTC DRUG PINE SALT 170g SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 20150201 OTC MONOGRAPH FINAL part355 HANUL TRADING CO., LTD. SODIUM FLUORIDE .374 g/170g N 20181231 69642-1200_d316c2c4-7b1c-4f4b-a55c-4633e27bb366 69642-1200 HUMAN OTC DRUG PINE SALT 140g SODIUM FLUORIDE PASTE, DENTIFRICE ORAL 20150201 OTC MONOGRAPH FINAL part355 HANUL TRADING CO., LTD. SODIUM FLUORIDE .308 g/140g N 20181231 69642-1300_59931787-286d-4bb8-a96b-dbc916366521 69642-1300 HUMAN OTC DRUG Antiphlamine Pain Relieving Flurbiprofen PATCH TOPICAL 20150901 UNAPPROVED DRUG OTHER HANUL TRADING CO., LTD. FLURBIPROFEN 33 mg/51 N 20181231 69642-1400_52c1413e-2814-367b-e054-00144ff88e88 69642-1400 HUMAN OTC DRUG Bamboo Salt 160g Sodium Lauryl Sulfate PASTE, DENTIFRICE ORAL 20150319 OTC MONOGRAPH NOT FINAL part356 Hanul Trading Co., Ltd. SODIUM LAURYL SULFATE 1.21 g/160g N 20181231 69642-1600_b7b9a4a2-c08f-4db0-bf2e-2e5a2ab09c4f 69642-1600 HUMAN OTC DRUG Antiphlamine Coin Plaster Methyl salicylate(KP) 5.541mg, L-menthol(KP), 2.769mg, dl-camphor(KP), 1.108mg, Mentha Oil(KP) 0.693mg, Tocopherol Acetate(KP) 0.308mg, Diphenhydramine(KP) 0.246mg, Vanillyl nonylamide(In-house) 0.046mg PATCH TOPICAL 20161010 UNAPPROVED DRUG OTHER Hanul Trading Co., Ltd. LEVOMENTHOL; CAMPHOR (SYNTHETIC); DIPHENHYDRAMINE; .ALPHA.-TOCOPHEROL, DL-; METHYL SALICYLATE; PEPPERMINT OIL; NONIVAMIDE 2.769; 1.108; .246; .308; 5.541; .693; .046 mg/.2832g; mg/.2832g; mg/.2832g; mg/.2832g; mg/.2832g; mg/.2832g; mg/.2832g N 20181231 69643-101_3b6d85e0-ea4b-4b96-b73a-bbcdae142a3f 69643-101 HUMAN OTC DRUG ONEBACK MENTHOL GEL TOPICAL 20150303 OTC MONOGRAPH NOT FINAL part348 WORLD WIDE MEDICAL SERVICES, INC. MENTHOL 3.9 g/100mL E 20171231 69646-704_3a562304-950e-4c81-a443-50113fe796d4 69646-704 HUMAN PRESCRIPTION DRUG Novacort hydrocortisone acetate and pramoxine hydrochloride GEL TOPICAL 20150301 UNAPPROVED DRUG OTHER Novum Pharma, LLC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 20; 10 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69646-705_cc159615-d371-4f5a-8f2b-4386747709d3 69646-705 HUMAN PRESCRIPTION DRUG ALCORTIN A iodoquinol, hydrocortisone acetate and aloe vera leaf GEL TOPICAL 20150301 UNAPPROVED DRUG OTHER Novum Pharma, LLC IODOQUINOL; HYDROCORTISONE ACETATE; ALOE VERA LEAF 10; 20; 10 mg/g; mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69646-706_e7f56ef2-d3eb-4747-923b-3f48cff5ee4b 69646-706 HUMAN PRESCRIPTION DRUG Aloquin iodoquinol and aloe vera leaf GEL TOPICAL 20150301 UNAPPROVED DRUG OTHER Novum Pharma, LLC IODOQUINOL; ALOE VERA LEAF 12.5; 10 mg/g; mg/g N 20181231 69646-716_13eca446-3cdf-48c0-8ef9-1799c0cfa3da 69646-716 HUMAN PRESCRIPTION DRUG QUINJA Iodoquinol and Aloe Polysaccharide GEL TOPICAL 20170720 UNAPPROVED DRUG OTHER Novum Pharma, LLC IODOQUINOL; ALOE VERA LEAF 12.5; 10 mg/g; mg/g N 20181231 69647-001_440d4522-cc3b-4757-8204-df6e81b96f74 69647-001 HUMAN OTC DRUG Odynia-R Regular LIDOCAINE, MENTHOL PATCH TOPICAL 20150312 OTC MONOGRAPH NOT FINAL part348 Ursh Pharmaceutical Inc. LIDOCAINE; MENTHOL 4; 1 g/100g; g/100g E 20171231 69647-002_606ad625-93aa-4bd5-b292-1d81365bb878 69647-002 HUMAN OTC DRUG Odynia-UUltra Patch Ultra Patch LIDOCAINE, CAPSICUM PATCH TOPICAL 20150312 OTC MONOGRAPH NOT FINAL part348 Ursh Pharmaceutical Inc. LIDOCAINE; CAPSICUM 4; .03 g/100g; g/100g E 20171231 69647-003_874fcddd-1ceb-49a1-9487-fe199923f046 69647-003 HUMAN OTC DRUG Odynia-U LIDOCAINE, CAPSICUM PATCH TOPICAL 20150312 OTC MONOGRAPH NOT FINAL part348 Ursh Pharmaceutical Inc. LIDOCAINE; CAPSICUM 4; .03 g/100g; g/100g E 20171231 69650-001_11e7755e-9533-4eda-9feb-45ded7705dd7 69650-001 HUMAN OTC DRUG Capment Menthol, Capsaicin PATCH TOPICAL 20150324 UNAPPROVED DRUG OTHER Original Patch Company Inc MENTHOL; CAPSAICIN .04; .00375 1/100g; 1/100g E 20171231 69651-000_a98db59f-0494-4828-bc76-44e3676100eb 69651-000 HUMAN OTC DRUG Unicowipes Benzethonium Chloride CLOTH TOPICAL 20150319 OTC MONOGRAPH NOT FINAL part333A Unicoadds Corp. BENZETHONIUM CHLORIDE .001 mg/1 E 20171231 69652-000_eec8e4a2-768b-48db-bc96-1f67869e74cf 69652-000 HUMAN OTC DRUG Unicowipes Benzethonium Chloride CLOTH TOPICAL 20150319 OTC MONOGRAPH NOT FINAL part333A Sabah Gida Saglik Temizlik Urunleri Dolum Ve Ambalaj Sana BENZETHONIUM CHLORIDE .001 mg/1 E 20171231 69653-010_b8a54e1d-8d26-4976-b516-0657b8fa1459 69653-010 HUMAN OTC DRUG Far Infra Silver Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20150201 OTC MONOGRAPH FINAL part355 Jewoo Medical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 69653-020_69eebcb9-87cb-4831-a867-963b1f4edd9b 69653-020 HUMAN OTC DRUG Finefra Silver Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20150301 OTC MONOGRAPH FINAL part355 Jewoo Medical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 69654-239_23a44b91-1f72-4304-89e3-d68626736fae 69654-239 HUMAN PRESCRIPTION DRUG Natesto testosterone GEL NASAL 20170901 NDA NDA205488 Aytu BioScience, Inc. TESTOSTERONE 5.5 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] CIII N 20181231 69656-101_4eb04a15-e09b-458d-b0ba-950f4ae17fc3 69656-101 HUMAN PRESCRIPTION DRUG Varubi rolapitant TABLET ORAL 20151007 NDA NDA206500 Tesaro, Inc. ROLAPITANT HYDROCHLORIDE 90 mg/1 Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 69656-102_4eb04a15-e09b-458d-b0ba-950f4ae17fc3 69656-102 HUMAN PRESCRIPTION DRUG Varubi rolapitant INJECTION, EMULSION INTRAVENOUS 20171025 NDA NDA208399 Tesaro, Inc. ROLAPITANT 1.8 mg/mL Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 69656-103_a4dd3f45-ffef-4e65-a9c5-14773f43b778 69656-103 HUMAN PRESCRIPTION DRUG ZEJULA niraparib CAPSULE ORAL 20170327 NDA NDA208447 TESARO, Inc. NIRAPARIB 100 mg/1 Poly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA] N 20191231 69658-101_ebd62e51-1667-4483-8e9e-4da8ed8e1de5 69658-101 HUMAN OTC DRUG MOEMO CERACOS Black Salicylic Acid SHAMPOO TOPICAL 20150311 UNAPPROVED DRUG OTHER MOEMO CO. SALICYLIC ACID .2 1/300g E 20171231 69660-201_acb1cfd2-6ab1-4051-921c-225718e1f10f 69660-201 HUMAN PRESCRIPTION DRUG Rubraca rucaparib TABLET, FILM COATED ORAL 20161219 NDA NDA209115 Clovis Oncology, Inc. RUCAPARIB CAMSYLATE 200 mg/1 Poly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA] N 20181231 69660-202_acb1cfd2-6ab1-4051-921c-225718e1f10f 69660-202 HUMAN PRESCRIPTION DRUG Rubraca rucaparib TABLET, FILM COATED ORAL 20170501 NDA NDA209115 Clovis Oncology, Inc. RUCAPARIB CAMSYLATE 250 mg/1 Poly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA] N 20181231 69660-203_acb1cfd2-6ab1-4051-921c-225718e1f10f 69660-203 HUMAN PRESCRIPTION DRUG Rubraca rucaparib TABLET, FILM COATED ORAL 20161219 NDA NDA209115 Clovis Oncology, Inc. RUCAPARIB CAMSYLATE 300 mg/1 Poly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA] N 20181231 69661-101_dee6aed3-a52e-4ca2-a2d3-1482c9b26731 69661-101 HUMAN OTC DRUG Dr Su Secret Perfume EUTREMA JAPONICUM WHOLE LIQUID TOPICAL 20150318 UNAPPROVED DRUG OTHER SOUL Co., Ltd. EUTREMA JAPONICUM WHOLE .1 1/5mL E 20171231 69662-111_c0bfc878-a301-4957-a6f6-58b77a3358eb 69662-111 HUMAN OTC DRUG Refresher alcohol LIQUID TOPICAL 20160330 OTC MONOGRAPH NOT FINAL part333E Jao Limited ALCOHOL 65 mL/100mL E 20171231 69663-1001_88b0ddc2-491f-474a-b4eb-b5438b1c20f6 69663-1001 HUMAN OTC DRUG SUN KILLING GRAPEFRUIT GLYCERIN GEL TOPICAL 20150308 OTC MONOGRAPH FINAL part347 SA Cosmetic GLYCERIN 5 g/100mL E 20171231 69663-2001_1adc88e9-2754-4998-9c00-dc7ed66b0ed5 69663-2001 HUMAN OTC DRUG YEAST ULTRA DEEP CLEANSING WHIP FOAM GLYCERIN LIQUID TOPICAL 20150308 OTC MONOGRAPH FINAL part347 SA Cosmetic GLYCERIN 16 g/100mL E 20171231 69664-001_86313d2d-b200-4a00-b71c-c9fbc838d04c 69664-001 HUMAN OTC DRUG Dynamo Delay Lidocaine SPRAY TOPICAL 20150513 OTC MONOGRAPH FINAL part348 Momentum Management LIDOCAINE 10 mg/.08mL E 20171231 69665-210_1f09850e-f4b2-48ef-96b6-8d313c9cfeec 69665-210 HUMAN PRESCRIPTION DRUG medPREDkit Plus Methylprednisolone Tablets KIT 20180124 NDA AUTHORIZED GENERIC NDA011153 MedArbor LLC N 20191231 69665-215_0fd35dfb-a85f-4f98-9436-186fd1557936 69665-215 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20170701 ANDA ANDA204922 Medarbor Llc OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 69665-216_32789375-e811-41e0-ba87-0d79ff43ed14 69665-216 HUMAN PRESCRIPTION DRUG Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate CAPSULE ORAL 20170701 ANDA ANDA204922 Medarbor Llc OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 69665-610_9bdde497-3965-473a-a5e1-e111f8abd00b 69665-610 HUMAN PRESCRIPTION DRUG LiProZonePak lidocaine and prilocaine CREAM TOPICAL 20161206 ANDA ANDA076290 MedArbor LLC LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 69665-828_81e93ac8-edfd-43b4-9536-0f5f4971829c 69665-828 HUMAN PRESCRIPTION DRUG Medolor Pak Lidocaine and Prilocaine Cream Kit Lidocaine and Prilocaine KIT 20160809 ANDA ANDA076290 MedArbor LLC N 20181231 69666-252_5d1de191-6433-935b-e053-2991aa0a35d2 69666-252 HUMAN OTC DRUG Manteca Maslac Camphor,Menthol, methyl salicylate OINTMENT TOPICAL 20150317 OTC MONOGRAPH NOT FINAL part348 Genuine Drugs MENTHOL; CAMPHOR (NATURAL); METHYL SALICYLATE 1.25; 5; 10 g/100g; g/100g; g/100g N 20181231 69666-368_1185224d-afeb-723c-e054-00144ff88e88 69666-368 HUMAN OTC DRUG Blue Ice Pain Relieving Menthol GEL TOPICAL 20150317 OTC MONOGRAPH NOT FINAL part348 Genuine Drugs MENTHOL; CAPSAICIN .05; .00025 g/g; g/g E 20171231 69666-831_5d1de191-6415-935b-e053-2991aa0a35d2 69666-831 HUMAN OTC DRUG Bengama Antifungal Tolnaftate SOLUTION TOPICAL 20150420 OTC MONOGRAPH FINAL part333C Genuine Drugs TOLNAFTATE 1 mg/100mL N 20181231 69666-871_5d1d134b-71bd-5104-e053-2991aa0a4836 69666-871 HUMAN OTC DRUG Boraqua Eye Wash water SOLUTION OPHTHALMIC 20150420 OTC MONOGRAPH FINAL part349 Genuine Drugs WATER 99.05 mL/100mL N 20181231 69666-962_5d1de191-6424-935b-e053-2991aa0a35d2 69666-962 HUMAN OTC DRUG Balsang Pain Relief Camphor,Menthol, methyl salicylate SOLUTION TOPICAL 20150420 OTC MONOGRAPH NOT FINAL part348 Genuine Drugs MENTHOL, (+)-; METHYL SALICYLATE; CAMPHOR, (-)- 1.5; 5; 1.5 mg/100mL; mg/100mL; mg/100mL N 20181231 69668-120_5d69215d-3754-782f-e053-2a91aa0a2d82 69668-120 HUMAN PRESCRIPTION DRUG Deltasone Prednisone TABLET ORAL 20090803 ANDA ANDA083677 Oculus Innovative Sciences PREDNISONE 20 mg/20mg N 20181231 69668-431_1ec7dd0d-c02d-33db-e054-00144ff8d46c 69668-431 HUMAN PRESCRIPTION DRUG Mondoxyne Doxycycline CAPSULE ORAL 20150528 ANDA ANDA204446 Oculus Innovative Sciences DOXYCYCLINE 50 mg/50mg N 20181231 69668-432_1f803c2c-35b4-71b8-e054-00144ff88e88 69668-432 HUMAN PRESCRIPTION DRUG Mondoxyne Doxycycline CAPSULE ORAL 20150528 ANDA ANDA204446 Oculus Innovative Scicences DOXYCYCLINE 75 mg/75mg N 20181231 69668-433_1f80aef4-3caa-42ec-e054-00144ff8d46c 69668-433 HUMAN PRESCRIPTION DRUG Mondoxyne NL 100mg Doxycycline CAPSULE ORAL 20150528 ANDA ANDA204446 Oculus Innovative Sciences DOXYCYCLINE 100 mg/100mg N 20181231 69670-900_44ea546c-d277-526e-e054-00144ff88e88 69670-900 HUMAN OTC DRUG Stefano Stick Aluminium Chlorohydrate STICK TOPICAL 20150518 OTC MONOGRAPH FINAL part350 Impulsora Sahuayo, S.A. de C.V ALUMINUM CHLOROHYDRATE 25 g/100mL E 20171231 69673-635_482d946f-62a7-0db3-e054-00144ff8d46c 69673-635 HUMAN OTC DRUG Cape Cod Sunscreen Plus SPF 30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20150314 OTC MONOGRAPH NOT FINAL part352 Cape Cod All Natural, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 69674-100_30c68860-c800-5dbb-e054-00144ff8d46c 69674-100 HUMAN OTC DRUG Hand Sanitizer Ethanol LIQUID TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part333E Saraya Healthcare ALCOHOL 62 mL/100mL N 20181231 69674-110_30c6ff5a-fbee-45c4-e054-00144ff88e88 69674-110 HUMAN OTC DRUG Healthcare Personnel Handwash Ethanol, Benzalkonium Chloride LIQUID TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part333E Saraya Healthcare BENZALKONIUM CHLORIDE; ALCOHOL .1; 65.9 mg/100mL; mL/100mL N 20181231 69674-210_3075e40b-41c4-56c6-e054-00144ff88e88 69674-210 HUMAN OTC DRUG Antimicrobial Foaming Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20160414 OTC MONOGRAPH NOT FINAL part333E Saraya Healthcare BENZALKONIUM CHLORIDE .12 mg/100mL N 20181231 69675-3273_153b54a7-4476-35bd-e054-00144ff88e88 69675-3273 HUMAN OTC DRUG THE ECZEMA FUCUS VESICULOSUS, CENTELLA ASIATICA, ALOE, MELISSA OFFICINALIS SOAP TOPICAL 20150501 UNAPPROVED HOMEOPATHIC Naples Soap Company FUCUS VESICULOSUS; CENTELLA ASIATICA; MELISSA OFFICINALIS; ALOE 1; 1; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 69676-0012_5ccc4c0f-5d19-0937-e053-2991aa0a107a 69676-0012 HUMAN OTC DRUG Sleepology Alfalfa, Avena sativa, Chamomilla, Eschscholtzia californica, Gelsemium sempervirens, Nux moschata, Passiflora incarnata, Piper methysticum, Valeriana officinalis TABLET, CHEWABLE ORAL 20160321 UNAPPROVED HOMEOPATHIC Genexa LLC ALFALFA; AVENA SATIVA FLOWERING TOP; ESCHSCHOLZIA CALIFORNICA; PASSIFLORA INCARNATA FLOWERING TOP; NUTMEG; VALERIAN; PIPER METHYSTICUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA CHAMOMILLA WHOLE 6; 6; 6; 6; 9; 6; 6; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69676-0014_4c712aa4-43cf-37dd-e054-00144ff8d46c 69676-0014 HUMAN OTC DRUG Leg Cramp Rx Angustura vera, Belladonna, Berberis vulgaris, Colchicum autumnale, Colocynthis, Ignatia amara, Jatropha curcas, Lycopodium clavatum, Nux moshchata, Rhus toxicodendron, Secale cornutum, Veratrum album TABLET, CHEWABLE ORAL 20160321 UNAPPROVED HOMEOPATHIC Genexa LLC ATROPA BELLADONNA WHOLE; ANGOSTURA BARK; BERBERIS VULGARIS ROOT BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; STRYCHNOS IGNATII SEED; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; NUTMEG; TOXICODENDRON PUBESCENS LEAF; CLAVICEPS PURPUREA SCLEROTIUM; VERATRUM ALBUM ROOT; COLCHICUM AUTUMNALE BULB 12; 12; 6; 12; 12; 12; 6; 6; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69676-0021_4c7124a0-9ac0-398e-e054-00144ff8d46c 69676-0021 HUMAN OTC DRUG Jet Lag Rx Arnica montana, Cinchona officinalis, Cocculus indicus, Coffea cruda, Tabacum TABLET, CHEWABLE ORAL 20160321 UNAPPROVED HOMEOPATHIC Genexa LLC ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; TOBACCO LEAF; CINCHONA OFFICINALIS BARK; ARNICA MONTANA 12; 6; 6; 12; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69676-0022_5cccc071-9a7f-2995-e053-2991aa0a7f9a 69676-0022 HUMAN OTC DRUG Stress Relief Aconitum napellus, Calcarea carbonica, Gelsemium sempervirens, Lycopodium clavatum, Nux vomica, Passiflora incarnata, Valeriana officinalis TABLET, CHEWABLE ORAL 20160321 UNAPPROVED HOMEOPATHIC Genexa LLC ACONITUM NAPELLUS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LYCOPODIUM CLAVATUM SPORE; PASSIFLORA INCARNATA FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS NUX-VOMICA SEED; VALERIAN 12; 6; 12; 3; 12; 12; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69676-0024_5ccc4c0f-5d2a-0937-e053-2991aa0a107a 69676-0024 HUMAN OTC DRUG Cold Crush Adult Allium Cepa, Belladonna, Bryonia alba, Euphrasia officinalis, Gelsemium sempervirens, Nux vomica, Pulsatilla nigrans, Rhus toxicodendron, Sabadilla TABLET, CHEWABLE ORAL 20160321 UNAPPROVED HOMEOPATHIC Genexa LLC GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA PRATENSIS; ONION; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPHRASIA STRICTA; TOXICODENDRON PUBESCENS SHOOT; STRYCHNOS NUX-VOMICA SEED; SCHOENOCAULON OFFICINALE SEED 12; 6; 6; 12; 12; 6; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69676-0025_4c7124a0-9af0-398e-e054-00144ff8d46c 69676-0025 HUMAN OTC DRUG Flu Fix Aconitum napellus, Allium cepa, Anis barbariae, Bryonia alba, Echinacea angustifolia, Eupatorium perfollatum, Gelsemium sempervirens, Ipecacauanha, Nux vomica, Pulsatilla, Rhus toxicodendron TABLET, CHEWABLE ORAL 20160321 UNAPPROVED HOMEOPATHIC Genexa LLC STRYCHNOS NUX-VOMICA SEED; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; PULSATILLA PRATENSIS; TOXICODENDRON PUBESCENS SHOOT; ONION; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; ACONITUM NAPELLUS; EUPHRASIA STRICTA; CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE; IPECAC 12; 6; 12; 9; 12; 6; 9; 6; 12; 6; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69676-0026_4c7124a0-9b01-398e-e054-00144ff8d46c 69676-0026 HUMAN OTC DRUG Allergy D Childrens Allium cepa, Dulcamara, Euphrasia officinalis, Nux vomica, Pulsatilla, Rosa damascena, Sabidilla, Sinapis nigra, Wyethia helenoides TABLET, CHEWABLE ORAL 20160321 UNAPPROVED HOMEOPATHIC Genexa LLC EUPHRASIA STRICTA; PULSATILLA PRATENSIS; SCHOENOCAULON OFFICINALE SEED; SOLANUM DULCAMARA STEM; ONION; STRYCHNOS NUX-VOMICA SEED; ROSA DAMASCENA FLOWERING TOP; BLACK MUSTARD SEED; WYETHIA HELENIOIDES ROOT 12; 12; 12; 12; 12; 12; 6; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69676-0027_4c6c2afd-17ae-2615-e054-00144ff8d46c 69676-0027 HUMAN OTC DRUG Calm Keeper Aconitum napellus, Calcarea phosphorica, Chamomilla, Gelsemium sepervirens, Ignatia amara, Kali carbonicum, Passiflora incarnata, Valeriana officinalis TABLET, CHEWABLE ORAL 20161114 UNAPPROVED HOMEOPATHIC Genexa LLC TRIBASIC CALCIUM PHOSPHATE; MATRICARIA CHAMOMILLA WHOLE; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; VALERIAN; PASSIFLORA INCARNATA FLOWERING TOP; ACONITUM NAPELLUS 6; 6; 12; 12; 6; 3; 3; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69676-0031_4c712aa4-4403-37dd-e054-00144ff8d46c 69676-0031 HUMAN OTC DRUG Arnica Advantage Arnica montana, Calendula officinalis, Ledum palustre, Rhus toxicodendron, Ruta graveolens TABLET, CHEWABLE ORAL 20160321 UNAPPROVED HOMEOPATHIC Genexa LLC TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP 12; 30; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69676-0051_4c712aa4-4414-37dd-e054-00144ff8d46c 69676-0051 HUMAN OTC DRUG Cold Crush Childrens Allium cepa, Belladonna, Bryonia alba, Chamomilla, Echinacea angustifolia, Euphrasia officinalis, Gelsemium sempervirens, Ipecacuanha, Pulsatilla, Sambucus nigra TABLET, CHEWABLE ORAL 20160321 UNAPPROVED HOMEOPATHIC Genexa LLC ONION; ATROPA BELLADONNA WHOLE; BRYONIA ALBA ROOT; MATRICARIA CHAMOMILLA WHOLE; ECHINACEA ANGUSTIFOLIA; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; PULSATILLA PRATENSIS; SAMBUCUS NIGRA FLOWER 6; 12; 9; 6; 6; 6; 12; 12; 9; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69676-0071_4c712aa4-4425-37dd-e054-00144ff8d46c 69676-0071 HUMAN OTC DRUG Allergy D Allium cepa, Ambrosia artemisiifolia, Arundo mauritanica, Dulcamara, Euphrasia officinalis, Nux vomica, Pulsatilla, Ranunculus bulbosus, Sabadilla, Sinapis nigra, Sticta pulmonaria, Wyethia helenoides TABLET, CHEWABLE ORAL 20160321 UNAPPROVED HOMEOPATHIC Genexa LLC AMBROSIA ARTEMISIIFOLIA; STRYCHNOS NUX-VOMICA SEED; BLACK MUSTARD SEED; LOBARIA PULMONARIA; ARUNDO PLINIANA ROOT; RANUNCULUS BULBOSUS; PULSATILLA PRATENSIS; SCHOENOCAULON OFFICINALE SEED; SOLANUM DULCAMARA STEM; EUPHRASIA STRICTA; WYETHIA HELENIOIDES ROOT; ONION 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 69677-010_e8d56ba8-1a13-4b50-b14b-8c97a185063a 69677-010 HUMAN OTC DRUG VitaCin methyl salicylate, menthol, capsaicin CREAM TOPICAL 20150708 OTC MONOGRAPH NOT FINAL part348 MAS Management Group Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 5; .0375 g/100g; g/100g; g/100g N 20181231 69677-011_3b4d9084-612c-1049-e054-00144ff8d46c 69677-011 HUMAN OTC DRUG Menthol, Capsaicin Vitacin PATCH TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part348 MAS Management Group Inc. CAPSAICIN; MENTHOL .375; 50 mg/g; mg/g N 20181231 69677-020_4809d1a1-f59d-4f8e-a3f1-80e07af046c5 69677-020 HUMAN OTC DRUG AvaDerm lidocaine hcl, menthol CREAM TOPICAL 20150708 OTC MONOGRAPH NOT FINAL part348 MAS Management Group Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g N 20181231 69677-030_90c465fd-6e89-4af1-9814-966c29e073a9 69677-030 HUMAN PRESCRIPTION DRUG Rx-Specimen Collection Kit specimen collection kit KIT 20150723 ANDA ANDA078010 MAS Management Group Inc. N 20181231 69677-040_570d7ec9-e80e-0ae9-e054-00144ff88e88 69677-040 HUMAN PRESCRIPTION DRUG Capxib Celecoxib, Menthol, Capsaicin KIT ORAL; TOPICAL 20160408 UNAPPROVED DRUG OTHER MAS Management Group N 20181231 69677-050_8645401e-d409-4137-be11-ad9b1e05b36f 69677-050 HUMAN PRESCRIPTION DRUG Vita-Rx Diabetic Vitamin Vitamin C, Vitamin D, Vitamin E, Thiamine, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Biotin, Pantothenic Acid, Chromium CAPSULE, GELATIN COATED ORAL 20150811 UNAPPROVED DRUG OTHER MAS Management Group Inc. ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; CHROMIUM PICOLINATE; ALPHA LIPOIC ACID; UBIDECARENONE 120; .0625; 10; 1.5; 1.7; 20; 12.5; .8; .0025; 2.5; 10; .465; 150; 50 mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] E 20171231 69677-060_59b9d247-4ea1-54a3-e053-2a91aa0a1ad1 69677-060 HUMAN PRESCRIPTION DRUG LidoXib Celecoxib, Lidocaine, Menthol KIT ORAL 20150603 UNAPPROVED DRUG OTHER MAS Management Group N 20181231 69677-063_570d4f33-52e8-0654-e054-00144ff88e88 69677-063 HUMAN PRESCRIPTION DRUG SmartRx Gaba Kit GABAPENTIN, LIDOCAINE HCL, MENTHOL KIT ORAL; TOPICAL 20160401 UNAPPROVED DRUG OTHER MAS Management Group Inc. N 20181231 69677-064_33c5c6ca-3bbd-38a1-e054-00144ff8d46c 69677-064 HUMAN PRESCRIPTION DRUG MLD marcaine, lidocaine, dextrose KIT EPIDURAL; INFILTRATION; INTRAVENOUS 20160701 NDA NDA016964 MAS Management Group E 20171231 69677-069_56f9812f-cef8-7264-e054-00144ff88e88 69677-069 HUMAN PRESCRIPTION DRUG SmartRx Gaba-V Kit Gabapentin, Methyl Salicylate, Menthol, Capsaicin KIT 20090316 UNAPPROVED DRUG OTHER MAS Management Group Inc N 20181231 69677-071_5d6b905f-ed32-1ab7-e053-2a91aa0a816b 69677-071 HUMAN PRESCRIPTION DRUG MAS CARE-PAK DEXAMETHASONE Dexamethasone Sodium Phosphate KIT INTRAMUSCULAR; INTRAVENOUS; TOPICAL 20171101 ANDA ANDA040491 MAS Management Group Inc. N 20181231 69677-154_56d1e6f1-7b5a-3d73-e054-00144ff8d46c 69677-154 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 Mas Management Group, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69677-180_570ea921-8090-3559-e054-00144ff8d46c 69677-180 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Mas Management Group, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 69677-204_59bb2ba0-842d-63fc-e053-2a91aa0ade7f 69677-204 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Mas Management Group, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 69677-208_56f97583-5609-186b-e054-00144ff8d46c 69677-208 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Mas Management Group, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 69677-225_57ec3a3f-b5ad-3a97-e053-2a91aa0a788f 69677-225 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 Mas Management Group, Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 69677-293_58263978-0b93-5c86-e053-2a91aa0aa5e1 69677-293 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20110308 ANDA ANDA200272 Mas Management Group, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 69677-316_5b3602f4-54f1-9461-e053-2a91aa0a99b9 69677-316 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170701 NDA NDA022370 Mas Management Group, Inc. TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 69678-101_c3b7cf84-100a-4902-8e2a-faa762aba10f 69678-101 HUMAN OTC DRUG eez-away RELIEF Menthol SPRAY TOPICAL 20150319 OTC MONOGRAPH NOT FINAL part348 EEZAWAY RELIEF INC MENTHOL 1.25 g/100mL N 20181231 69679-000_b09cf7d7-e31f-4244-922e-6a3430990b5d 69679-000 HUMAN OTC DRUG Red Serum Witch Hazel GEL TOPICAL 20150318 OTC MONOGRAPH FINAL part347 ES Pure Vine, Inc. WITCH HAZEL 2.5 g/100g N 20181231 69679-020_2c86fca0-ee31-3ee1-e054-00144ff8d46c 69679-020 HUMAN OTC DRUG DR. COLOR EFFECT RED Niacinamide CREAM TOPICAL 20160223 UNAPPROVED DRUG OTHER ES PURE VINE INC. NIACINAMIDE 1 g/50mL N 20181231 69680-120_ff0011c6-a954-4993-9129-8a7dcc459f45 69680-120 HUMAN PRESCRIPTION DRUG LIDOCAINE LIDOCAINE OINTMENT TOPICAL 20171115 ANDA ANDA208822 VITRUVIAS THERAPEUTICS LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 69681-432_036fa5d4-a566-486a-aa26-c9a3f01fbcfe 69681-432 HUMAN OTC DRUG Preboost benzocaine LIQUID TOPICAL 20150330 OTC MONOGRAPH NOT FINAL part348 The Female Health Company d/b/a Veru Healthcare BENZOCAINE 4 g/100mL N 20181231 69683-101_174c2156-c64c-4497-9eb5-48710d24ff47 69683-101 HUMAN OTC DRUG DERMOSCRIBE ICHYBUM HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE CREAM TOPICAL 20150323 OTC MONOGRAPH NOT FINAL part348 XLMA PTY LTD HYDROCORTISONE; CLIOQUINOL 1; 1 g/100g; g/100g E 20171231 69683-201_e85c45f0-2cdc-45bf-a7c4-11ea39a150d0 69683-201 HUMAN OTC DRUG DERMOSCRIBE PSORIASIS LIQUOR CARBONIS DETERGENS, SALICYLIC ACID CREAM TOPICAL 20160221 OTC MONOGRAPH FINAL part358H DERMOSCRIBE PTY LTD COAL TAR; SALICYLIC ACID 5; 3 g/100g; g/100g E 20171231 69683-202_bd427c73-c412-449e-9bd6-bd1326ad7f8e 69683-202 HUMAN OTC DRUG DERMOSCRIBE SEBORRHEIC DERMATITIS SULFUR, SALICYLIC ACID, HYDROCORTISONE CREAM TOPICAL 20150323 OTC MONOGRAPH NOT FINAL part348 DERMOSCRIBE PTY LTD SULFUR; SALICYLIC ACID; HYDROCORTISONE 3; 3; 1 g/100g; g/100g; g/100g E 20171231 69684-200_01827bb1-d810-4d19-8f7f-b6b970fbc945 69684-200 HUMAN OTC DRUG SECRETIPSS SCALP HAIR ESSENTIAL BOOSTER INTENSE CARE FOR DAMAGED SCALPS AND HAIRS Allantoin SOLUTION TOPICAL 20150201 OTC MONOGRAPH FINAL part347 SECRETIPSS CO., LTD. ALLANTOIN .48 mg/80mL E 20171231 69684-210_2a17500f-f05d-4c67-addc-09b1e2082c6e 69684-210 HUMAN OTC DRUG SECRETIPSS SCALP HAIR ESSENTIAL TONIC PLUS HAIR REGROWTH TREATMENT WITH NATURAL INGREDIENTS AND VITAMIN COMPLEX Allantoin SOLUTION TOPICAL 20150201 OTC MONOGRAPH FINAL part347 SECRETIPSS CO., LTD. ALLANTOIN .48 mg/80mL E 20171231 69684-300_26cbfd51-da8c-4c39-83f6-cb51596d93db 69684-300 HUMAN OTC DRUG HAIRFILL SCALP HAIR ESSENTIAL TONIC PLUS Allantoin LIQUID TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SECRETIPSS CO., LTD. ALLANTOIN .54 mg/90mL E 20171231 69684-310_e2b8ebc0-42bb-4347-927f-68936710f7ac 69684-310 HUMAN OTC DRUG HAIRFILL SCALP HAIR ESSENTIAL BOOSTER Allantoin LIQUID TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SECRETIPSS CO., LTD. ALLANTOIN .54 mg/90mL E 20171231 69684-320_cebef84a-13c9-4c2c-b983-96e6af40a333 69684-320 HUMAN OTC DRUG HAIRFILL SCALP HAIR ESSENTIAL Dimethicone SHAMPOO TOPICAL 20150301 OTC MONOGRAPH FINAL part347 SECRETIPSS CO., LTD. DIMETHICONE 2.4 mg/240mL E 20171231 69685-101_46f4b21c-e77d-1c75-e054-00144ff8d46c 69685-101 HUMAN OTC DRUG StellaLife VEGA Oral Care Spray SPRAY DENTAL; SUBLINGUAL 20161210 UNAPPROVED HOMEOPATHIC StellaLife, Inc. HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; ACONITUM NAPELLUS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; CALCIUM SULFIDE; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA; MATRICARIA RECUTITA; ECHINACEA PURPUREA; GELSEMIUM SEMPERVIRENS ROOT; MERCURY 10; 30; 3; 3; 3; 8; 12; 18; 5; 3; 30; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69685-102_46f4b21c-e77d-1c75-e054-00144ff8d46c 69685-102 HUMAN OTC DRUG StellaLife VEGA Oral Care Gel Gel GEL DENTAL; TOPICAL 20161210 UNAPPROVED HOMEOPATHIC StellaLife, Inc. ACONITUM NAPELLUS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; MERCURY; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA; MATRICARIA RECUTITA; ECHINACEA PURPUREA; GELSEMIUM SEMPERVIRENS ROOT; CALCIUM SULFIDE 3; 3; 3; 10; 30; 10; 12; 18; 5; 3; 30; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69685-103_46f4b21c-e77d-1c75-e054-00144ff8d46c 69685-103 HUMAN OTC DRUG StellaLife VEGA Oral Care Rinse Rinse RINSE DENTAL 20161210 UNAPPROVED HOMEOPATHIC StellaLife, Inc. AZADIRACHTA INDICA BARK; CALENDULA OFFICINALIS FLOWER; ECHINACEA PURPUREA; PLANTAGO MAJOR 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69685-104_62978d57-4cac-8280-e053-2a91aa0ac9db 69685-104 HUMAN OTC DRUG StellaLife VEGA Oral Care Oral Hydration Mist Oral Hydration Mist SPRAY DENTAL 20180118 UNAPPROVED HOMEOPATHIC StellaLife, Inc. CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; AZADIRACHTA INDICA BARK; ECHINACEA PURPUREA 1; 1; 1; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 69685-105_46f4b21c-e77d-1c75-e054-00144ff8d46c 69685-105 HUMAN OTC DRUG StellaLife VEGA Oral Care Recovery Kit KIT DENTAL; SUBLINGUAL; TOPICAL 20161210 UNAPPROVED HOMEOPATHIC StellaLife, Inc. N 20181231 69688-001_cb105143-719c-4667-8c5e-7d86ca11c7f6 69688-001 HUMAN OTC DRUG dignity health medspa antibacterial Triclosan SOAP TOPICAL 20150609 OTC MONOGRAPH NOT FINAL part333E Jiangsu Xinheyuan Plastic Daily Chemical Co., Ltd. TRICLOSAN .3 g/100g N 20181231 69688-002_c8b2989c-4853-4731-a8f5-d3e2ad679866 69688-002 HUMAN OTC DRUG medspa antibacterial bar Triclosan SOAP TOPICAL 20150609 OTC MONOGRAPH NOT FINAL part333E Jiangsu Xinheyuan Plastic Daily Chemical Co., Ltd. TRICLOSAN .3 g/100g N 20181231 69688-104_33b07934-0be0-4341-8773-db7285034738 69688-104 HUMAN OTC DRUG bobbarker antibacterial bar Triclosan SOAP TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part333E Jiangsu Xinheyuan Plastic Daily Chemical Co., Ltd. TRICLOSAN .16 g/100g N 20181231 69689-7290_53a97f2a-26ec-4831-809e-1c85830f1130 69689-7290 HUMAN OTC DRUG Sport Sunscreen LiquidShade Avobenzone 2.00% Homosalate 12.00% Octisalate 5.00% Octocrylene 1.80% Oxybenzone 3.50% GEL TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 Phoebus Group, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 12; 5; 1.8; 3.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69691-150_11f7a728-c7bf-11a2-e054-00144ff88e88 69691-150 HUMAN OTC DRUG Glacierix capsaicin-menthol PATCH TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part348 Pharmaco Technology LLC CAPSAICIN; MENTHOL .0375; 5 g/100g; g/100g E 20171231 69693-410_61304306-da09-5c75-e053-2a91aa0a7c6b 69693-410 HUMAN OTC DRUG ABSORBINE JR MENTHOL CREAM TOPICAL 20150815 OTC MONOGRAPH NOT FINAL part348 Clarion Brands, LLC MENTHOL 2.5 g/100g N 20181231 69693-411_603e695d-1940-2442-e053-2a91aa0ab7f0 69693-411 HUMAN OTC DRUG Absorbine Jr. Plus Menthol LIQUID TOPICAL 20100624 OTC MONOGRAPH NOT FINAL part348 Clarion Brands, LLC MENTHOL 4 g/100mL N 20181231 69693-413_a6b602fc-24cc-4066-8a77-100d074e1967 69693-413 HUMAN OTC DRUG ABSORBINE JR PLUS ULTRA STRENGTH PAIN MENTHOL PATCH TOPICAL 20150815 OTC MONOGRAPH NOT FINAL part348 Clarion Brands, LLC MENTHOL 6500 mg/h N 20181231 69693-414_4dc1ce90-e14d-4a87-c922-12b8c3dd97e0 69693-414 HUMAN OTC DRUG Absorbine jr. Lidocaine Lidocaine PATCH TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part348 Clarion Brands, LLC LIDOCAINE 246 mg/1 N 20181231 69693-512_e5954380-c50b-4413-46a5-5edef5f3a133 69693-512 HUMAN OTC DRUG Cystex Plus methenamine, sodium salicylate TABLET ORAL 20151101 UNAPPROVED DRUG OTHER Clarion Brands, LLC METHENAMINE; SODIUM SALICYLATE 162; 162.5 mg/1; mg/1 N 20181231 69693-715_4a10a320-3104-44f4-a5e9-cb96f8dbe108 69693-715 HUMAN OTC DRUG CERTAIN DRI ROLL-ON Aluminum Chloride LIQUID TOPICAL 20151101 OTC MONOGRAPH FINAL part350 Clarion Brands, LLC ALUMINUM CHLORIDE .12 mg/mL N 20191231 69693-716_c2b7709a-6123-4fb6-ab3c-a87f02460315 69693-716 HUMAN OTC DRUG CERTAIN DRI SOLID Aluminum Sesquichlorohydrate STICK TOPICAL 20151101 OTC MONOGRAPH FINAL part350 Clarion Brands, LLC ALUMINUM SESQUICHLOROHYDRATE .25 g/g N 20181231 69693-717_ab7fdfc0-0a4a-85d8-a8f3-6c7a885d8e24 69693-717 HUMAN OTC DRUG CERTAIN DRI AM SOLID Aluminum Zirconium Trichlorohydrex Glycine STICK TOPICAL 20150616 OTC MONOGRAPH FINAL part350 Clarion Brands, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69693-718_868cda31-d034-a83b-c46c-35a8c05707d0 69693-718 HUMAN OTC DRUG CERTAIN DRI AM ROLL-ON Aluminum zirconium tetrachlorohydrex glycine LIQUID TOPICAL 20150616 OTC MONOGRAPH FINAL part350 Clarion Brands, LLC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100mL N 20181231 69693-719_e6c418d7-dafa-d288-d4bd-d1e8733c6c19 69693-719 HUMAN OTC DRUG Certain Dri Everyday Strength Clinical SOLID Aluminum Zirconium Trichlorohydrex Glycine STICK TOPICAL 20150616 OTC MONOGRAPH FINAL part350 Clarion Brands, LLC ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69693-815_6b983620-8c90-4f5e-883d-f5af98b54a02 69693-815 HUMAN OTC DRUG BABY ANTI MONKEY BUTT DIAPER RASH ZINC OXIDE, FERRIC OXIDE RED POWDER TOPICAL 20160101 OTC MONOGRAPH FINAL part347 Clarion Brands, LLC ZINC OXIDE; FERRIC OXIDE RED .076; .004 g/g; g/g N 20181231 69693-818_2363ca61-8bf1-4d0f-8104-8ba9316488fe 69693-818 HUMAN OTC DRUG BABY ANTI MONKEY BUTT DIAPER RASH ZINC OXIDE, CALAMINE CREAM TOPICAL 20160301 OTC MONOGRAPH FINAL part347 Clarion Brands, LLC ZINC OXIDE; FERRIC OXIDE RED .12; .02 g/g; g/g N 20181231 69694-010_fcc8ab2d-0e7e-482b-bf2c-ebf6a389e3ed 69694-010 HUMAN OTC DRUG PHYTON THERAPY CLEANSING BAR Allantoin SOAP TOPICAL 20150301 OTC MONOGRAPH FINAL part347 Nature In ALLANTOIN 1.3 g/100g E 20171231 69695-1974_2448c701-124c-0634-e054-00144ff88e88 69695-1974 HUMAN OTC DRUG Flexin Menthol and Capsaicin PATCH TOPICAL 20150713 OTC MONOGRAPH NOT FINAL part348 Whyteman Labs LLC CAPSAICIN; MENTHOL .000375; .05 1/1; 1/1 E 20171231 69696-636_48063228-ea23-498c-e054-00144ff88e88 69696-636 HUMAN OTC DRUG Come In The Sun SPF 30 OCTINOXATE, OXYBENZONE CREAM TOPICAL 20150314 OTC MONOGRAPH NOT FINAL part352 Daddy Wank LLC OCTINOXATE; OXYBENZONE .075; .05 g/g; g/g N 20181231 69697-976_d94a4508-d4bc-4ff8-a829-a9149e847047 69697-976 HUMAN PRESCRIPTION DRUG KIMVENT ORAL CARE Q4 Kit WITH CHG Chlorhexidine Gluconate and Hydrogen Peroxide KIT 19960507 ANDA ANDA074356 Halyard Health N 20181231 69697-980_35c5837d-d3e0-49ea-bbdd-9f3c031a3a67 69697-980 HUMAN OTC DRUG Kimvent Oral Care Toothbrush pack Cetylpyridinium Chloride KIT 20080313 OTC MONOGRAPH NOT FINAL part356 Halyard Health N 20181231 69697-982_35c8ebed-889e-4732-bd81-af8999553bf5 69697-982 HUMAN PRESCRIPTION DRUG Q2 Oral Care Kit with CHG Hydrogen peroxide and Chlorhexidine Gluconate KIT 19960507 ANDA ANDA074356 Halyard Health N 20181231 69697-983_78261de9-4192-4e88-a4e4-77dd7f829358 69697-983 HUMAN OTC DRUG Q2 Oral Care Kit Hydrogen peroxide KIT 20080826 OTC MONOGRAPH NOT FINAL part356 Halyard Health N 20181231 69697-986_4ea2da50-ef91-4105-b068-d94dfed088a9 69697-986 HUMAN OTC DRUG Oral Care Q4 Kit Hydrogen peroxide KIT 20080313 OTC MONOGRAPH NOT FINAL part356 Halyard Health N 20181231 69697-990_2112902a-e23d-4f97-a6a3-b2a668add68b 69697-990 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide LIQUID ORAL 20080826 OTC MONOGRAPH NOT FINAL part356 Halyard Health HYDROGEN PEROXIDE .015 mg/mL N 20181231 69697-993_2112902a-e23d-4f97-a6a3-b2a668add68b 69697-993 HUMAN OTC DRUG Kimvent Oral Care Suction Swab pack Hydrogen Peroxide KIT 20080826 OTC MONOGRAPH NOT FINAL part356 Halyard Health N 20181231 69698-1001_11fbde33-0185-13d5-e054-00144ff8d46c 69698-1001 HUMAN OTC DRUG PYUNG GANG ATO SOON Mineral Oil CREAM TOPICAL 20150402 UNAPPROVED DRUG OTHER Pyung Gang Oriental Medical Clinic MINERAL OIL .45 g/45g N 20181231 69698-2001_5866cd9f-4dd8-e9e3-e053-2a91aa0ade41 69698-2001 HUMAN OTC DRUG PYUNG GANG ATO SOON Mineral Oil CREAM TOPICAL 20150402 UNAPPROVED DRUG OTHER Pyung Gang Oriental Medical Clinic MINERAL OIL .45 g/45mL N 20181231 69701-8623_7ca528a0-360c-4a35-83ae-bede315712ef 69701-8623 HUMAN OTC DRUG Neuro Max Pain and Muscle Relief Gel Methyl Salicylate LOTION TOPICAL 20150409 OTC MONOGRAPH NOT FINAL part348 Starman Consulting LLC METHYL SALICYLATE 20 g/100g E 20171231 69704-100_63861869-1dcc-40a7-b379-28e2112768d8 69704-100 HUMAN OTC DRUG Co2 Polymer Mask Pack Glycerin KIT 20150327 OTC MONOGRAPH FINAL part347 BUKWANG Co.,Ltd E 20171231 69706-0203_67b34aa9-c584-4578-83d3-de9ea61d72d5 69706-0203 HUMAN OTC DRUG FAST RELIEF ARTROSAMIN Menthol, Methyl Salicylate CREAM TOPICAL 20131111 OTC MONOGRAPH NOT FINAL part348 Interfarma Corp MENTHOL; METHYL SALICYLATE 2.5; 15 g/100g; g/100g E 20171231 69706-0204_cf00f47d-d986-450a-a43c-f2f1871c395a 69706-0204 HUMAN OTC DRUG FAST RELIEF REUMACETIN Menthol, Methyl Salicylate CREAM TOPICAL 20131111 OTC MONOGRAPH NOT FINAL part348 Interfarma Corp MENTHOL; METHYL SALICYLATE 2.5; 15 g/100g; g/100g E 20171231 69708-101_f839392f-6de8-43b5-9fc1-dcef9dd23c99 69708-101 HUMAN OTC DRUG Wasabia Secret Perfume - Shamar EUTREMA JAPONICUM WHOLE LIQUID TOPICAL 20150320 UNAPPROVED DRUG OTHER Peniel World co., ltd. EUTREMA JAPONICUM WHOLE .1 1/5mL E 20171231 69709-101_dd902138-2fb0-4d2b-b293-3dcd9d85d186 69709-101 HUMAN OTC DRUG Premium Notamo Pathenol, Salicylic Acid SHAMPOO TOPICAL 20150330 UNAPPROVED HOMEOPATHIC HELLO INTERNATIONAL PANTHENOL; SALICYLIC ACID .2; .25 1/400mL; 1/400mL E 20171231 69709-102_b5946464-bebc-47b5-8bbc-bd5be154c5f5 69709-102 HUMAN OTC DRUG Notamo Hair Tonic Salicylic Acid, Panthenol LIQUID TOPICAL 20150408 UNAPPROVED DRUG OTHER HELLO INTERNATIONAL DEXPANTHENOL; SALICYLIC ACID .2; .25 1/120mL; 1/120mL E 20171231 69709-103_7b612640-35a2-4e14-b031-1aa2ae8d6a79 69709-103 HUMAN OTC DRUG Premium Notamo Pnathenol, Salicylic Acid SHAMPOO TOPICAL 20160229 UNAPPROVED DRUG OTHER HELLO INTERNATIONAL PANTHENOL; SALICYLIC ACID .002; .0025 1/400mL; 1/400mL E 20171231 69709-104_a22deebe-8580-4055-b1da-52befb7120d5 69709-104 HUMAN OTC DRUG Notamo Hair Tonic Salicylic Acid, Niacinamide LIQUID TOPICAL 20160229 UNAPPROVED DRUG OTHER HELLO INTERNATIONAL SALICYLIC ACID; NIACINAMIDE .005; .003 1/120mL; 1/120mL E 20171231 69709-105_07e1b88e-bd4f-4a13-9b56-8c1f11a59e85 69709-105 HUMAN OTC DRUG New Premium Notamo Panthenol, Niacinamide, Menthol, Salicylic Acid SHAMPOO TOPICAL 20160427 UNAPPROVED DRUG OTHER HELLO INTERNATIONAL PANTHENOL; NIACINAMIDE; MENTHOL; SALICYLIC ACID .005; .003; .0007; .0004 1/500mL; 1/500mL; 1/500mL; 1/500mL E 20171231 69709-106_3cc4ef4a-4911-4d84-952b-79d804ce5aee 69709-106 HUMAN OTC DRUG New Premium Notamo Tonic Panthenol, Niacinamide, Menthol, Salicylic Acid LIQUID TOPICAL 20160427 UNAPPROVED DRUG OTHER HELLO INTERNATIONAL PANTHENOL; NIACINAMIDE; MENTHOL; SALICYLIC ACID .002; .0001; .003; .0025 1/120mL; 1/120mL; 1/120mL; 1/120mL E 20171231 69711-003_18d3a20f-d7cc-3449-e054-00144ff88e88 69711-003 HUMAN OTC DRUG ACNE PRONE Salicylic Acid 1.5% GEL TOPICAL 20150618 OTC MONOGRAPH FINAL part333D Biological Health Group Corporation SALICYLIC ACID 1.5 g/100mL N 20181231 69711-004_1923aca8-4e80-4c7e-e054-00144ff88e88 69711-004 HUMAN OTC DRUG ACNE PRONE Salicylic Acid 2% GEL TOPICAL 20150618 OTC MONOGRAPH FINAL part333D Biological Health Group Corporation SALICYLIC ACID 2 g/100mL N 20181231 69711-005_18d4f5f7-a4ce-7425-e054-00144ff88e88 69711-005 HUMAN OTC DRUG ALL PURPOSE Colloidal Oatmeal 1.5% CREAM TOPICAL 20150618 OTC MONOGRAPH FINAL part347 Biological Health Group Corporation OATMEAL 1.5 g/100mL N 20181231 69711-006_18d71c9f-0296-45c0-e054-00144ff8d46c 69711-006 HUMAN OTC DRUG FORMULA A Camphor 0.5% CREAM TOPICAL 20150618 OTC MONOGRAPH NOT FINAL part348 Biological Health Group Corporation CAMPHOR (NATURAL) .5 g/100mL N 20181231 69711-007_18e6fa9a-444e-3da9-e054-00144ff88e88 69711-007 HUMAN OTC DRUG FORMULA H Glycerin 25% CREAM RECTAL; TOPICAL 20150618 OTC MONOGRAPH FINAL part346 Biological Health Group Corporation GLYCERIN 25 g/100mL N 20181231 69711-008_150d4a1a-2a3d-054f-e054-00144ff88e88 69711-008 HUMAN OTC DRUG MOBILITY Topical Analgesic Menthol 1.5% CREAM TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part348 Biological Health Group Corporation MENTHOL 1.5 g/100mL N 20181231 69711-009_1923d661-9396-655b-e054-00144ff8d46c 69711-009 HUMAN OTC DRUG BABY Specialty Cream ZINC OXIDE 12% CREAM TOPICAL 20150618 OTC MONOGRAPH FINAL part347 Biological Health Group Corporation ZINC OXIDE 12 g/100mL N 20181231 69711-010_54dbdbc2-cdaf-17cf-e054-00144ff8d46c 69711-010 HUMAN OTC DRUG Deserving Health Baby Specialty Cream ZINC OXIDE 1.25% CREAM TOPICAL 20170721 OTC MONOGRAPH FINAL part347 Deserving Health International Corp ZINC OXIDE 12 g/100mL N 20181231 69711-105_3c56b732-9a3f-72a3-e054-00144ff8d46c 69711-105 HUMAN OTC DRUG SYMBIO ASPER DROPS Aspergillus niger LIQUID ORAL 20160825 UNAPPROVED HOMEOPATHIC Symbiopathic ASPERGILLUS NIGER VAR. NIGER 4 [hp_X]/mL N 20181231 69711-115_3c56d039-1bce-717c-e054-00144ff88e88 69711-115 HUMAN OTC DRUG SYMBIO PARA DROPS Candida parapsilosis LIQUID ORAL 20160825 UNAPPROVED HOMEOPATHIC Symbiopathic CANDIDA PARAPSILOSIS 4 [hp_X]/mL N 20181231 69711-125_3c57a53e-baec-141e-e054-00144ff88e88 69711-125 HUMAN OTC DRUG SYMBIO MUC EYE DROPS Mucor racemosus LIQUID OPHTHALMIC 20160825 UNAPPROVED HOMEOPATHIC Symbiopathic MUCOR RACEMOSUS 5 [hp_X]/mL N 20181231 69711-135_3c56b732-9a69-72a3-e054-00144ff8d46c 69711-135 HUMAN OTC DRUG SYMBIO MUC DROPS Mucor racemosus LIQUID ORAL 20160825 UNAPPROVED HOMEOPATHIC Symbiopathic MUCOR RACEMOSUS 4 [hp_X]/mL N 20181231 69711-145_3c56d039-1bf9-717c-e054-00144ff88e88 69711-145 HUMAN OTC DRUG SYMBIO MUC/ASPERGILLUS DROPS Mucor racemosus, Aspergillus niger LIQUID ORAL 20160825 UNAPPROVED HOMEOPATHIC Symbiopathic MUCOR RACEMOSUS; ASPERGILLUS NIGER VAR. NIGER 4; 4 [hp_X]/mL; [hp_X]/mL N 20181231 69711-152_5514545e-34df-4500-e054-00144ff88e88 69711-152 HUMAN OTC DRUG Derma Soleil Natural Sunblock SPF 15 Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part352 Derma Soleil OCTISALATE; OXYBENZONE; OCTINOXATE; OCTOCRYLENE 3; 4; 6; 3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69711-155_3c55c444-2460-547b-e054-00144ff88e88 69711-155 HUMAN OTC DRUG SYMBIO NOT DROPS Penicillium notatum LIQUID ORAL 20160825 UNAPPROVED HOMEOPATHIC Symbiopathic PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 4 [hp_X]/mL N 20181231 69711-165_3c56e7f3-731f-0657-e054-00144ff8d46c 69711-165 HUMAN OTC DRUG SYMBIO PARA/ROQUEFORTI DROPS Candida parapsilosis, Penicillium roqueforti LIQUID ORAL 20160825 UNAPPROVED HOMEOPATHIC Symbiopathic PENICILLIUM ROQUEFORTI; CANDIDA PARAPSILOSIS 4; 4 [hp_X]/mL; [hp_X]/mL N 20181231 69711-175_3c574708-24d8-0465-e054-00144ff88e88 69711-175 HUMAN OTC DRUG SYMBIO QUENT DROPS Penicillium frequentans LIQUID ORAL 20160825 UNAPPROVED HOMEOPATHIC Symbiopathic PENICILLIUM GLABRUM 4 [hp_X]/mL N 20181231 69711-185_3c56d039-1bf1-717c-e054-00144ff88e88 69711-185 HUMAN OTC DRUG SYMBIO FORTI DROPS Penicillium roqueforti LIQUID ORAL 20160825 UNAPPROVED HOMEOPATHIC Symbiopathic PENICILLIUM ROQUEFORTI 4 [hp_X]/mL N 20181231 69711-205_3c57705c-287d-131f-e054-00144ff8d46c 69711-205 HUMAN OTC DRUG SYMBIO CERE DROPS Bacillus cereus LIQUID ORAL 20160825 UNAPPROVED HOMEOPATHIC Symbiopathic BACILLUS CEREUS 6 [hp_X]/mL N 20181231 69711-215_3c57705c-2891-131f-e054-00144ff8d46c 69711-215 HUMAN OTC DRUG SYMBIO FIRM DROPS Bacillus firmus LIQUID ORAL 20160825 UNAPPROVED HOMEOPATHIC Symbiopathic BACILLUS FIRMUS 6 [hp_X]/mL N 20181231 69711-235_3c57705c-28a6-131f-e054-00144ff8d46c 69711-235 HUMAN OTC DRUG SYMBIO TILIS DROPS Bacillus subtilis LIQUID ORAL 20160825 UNAPPROVED HOMEOPATHIC Symbiopathic BACILLUS SUBTILIS 6 [hp_X]/mL N 20181231 69711-300_54d6503d-e6ab-4c2c-e054-00144ff88e88 69711-300 HUMAN OTC DRUG Deserving Health Natural Age-Free Facial Sunblock Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part352 Deserving Health International Corp OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 7.5; 4; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69711-301_54d5fc04-55a8-491b-e054-00144ff8d46c 69711-301 HUMAN OTC DRUG Deserving Health Natural Sunblock Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part352 Deserving Health International Corp OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 7.5; 4; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69711-305_5514545e-34e1-4500-e054-00144ff88e88 69711-305 HUMAN OTC DRUG Derma Soleil Natural Sunblock SPF 30 Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part352 Derma Soleil OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 7.5; 4; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69711-307_5512778c-1e09-4545-e054-00144ff8d46c 69711-307 HUMAN OTC DRUG Derma Soleil Kids Natural Sunblock SPF 30 Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part352 Derma Soleil OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 7.5; 4; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69711-308_55135e2c-52e9-3e36-e054-00144ff8d46c 69711-308 HUMAN OTC DRUG Derma Soleil Dry Sport SPF 30 Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part352 Derma Soleil OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 7.5; 4; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69711-310_55116052-48e2-555b-e054-00144ff8d46c 69711-310 HUMAN OTC DRUG Derma Soleil Natural Age-Free Facial Sunblock SPF 30 Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part352 Derma Soleil OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 7.5; 4; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69711-451_54d5fc04-55b2-491b-e054-00144ff8d46c 69711-451 HUMAN OTC DRUG Deserving Health Natural Sunblock Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part352 Deserving Health International Corp OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 7.5; 5; 6; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69711-457_5512bc12-fe9e-1398-e054-00144ff88e88 69711-457 HUMAN OTC DRUG Derma Soleil Kids Natural Sunblock SPF 45 Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part352 Derma Soleil OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 7.5; 5; 6; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69711-458_55140bff-58df-3ae2-e054-00144ff88e88 69711-458 HUMAN OTC DRUG Derma Soleil Natural Sunblock SPF 45 Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part352 Derma Soleil OCTINOXATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE 7.5; 5; 6; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69712-010_3bde65db-e204-4deb-917e-c78c2d4237ca 69712-010 HUMAN OTC DRUG OROCHE DERMA REJUVENATOR Witch Hazel CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 OROCHE WITCH HAZEL .001 mg/12mL E 20171231 69713-020_f0617707-b966-4585-bdee-46898d6a804f 69713-020 HUMAN OTC DRUG Vincent Longo Ultra Light Canvas Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Shade 1 OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20150320 OTC MONOGRAPH NOT FINAL part352 Zaimu Holdings LLC DBA Vincent Longo Cosmetics OCTINOXATE; OCTOCRYLENE; AVOBENZONE 70; 40; 25 mg/mL; mg/mL; mg/mL E 20171231 69713-021_00b17472-bea4-4ce0-9582-275274a801c9 69713-021 HUMAN OTC DRUG Vincent Longo Ultra Light Canvas Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Shade 2 OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20150320 OTC MONOGRAPH NOT FINAL part352 Zaimu Holdings LLC DBA Vincent Longo Cosmetics OCTINOXATE; OCTOCRYLENE; AVOBENZONE 70; 40; 25 mg/mL; mg/mL; mg/mL E 20171231 69713-022_24295c0d-2dad-465e-b7af-092f590bb0bb 69713-022 HUMAN OTC DRUG Vincent Longo Ultra Light Canvas Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Shade 3 OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20150320 OTC MONOGRAPH NOT FINAL part352 Zaimu Holdings LLC DBA Vincent Longo Cosmetics OCTINOXATE; OCTOCRYLENE; AVOBENZONE 70; 40; 25 mg/mL; mg/mL; mg/mL E 20171231 69713-023_c52ede1f-9d3f-4383-b833-62b734544b61 69713-023 HUMAN OTC DRUG Vincent Longo Ultra Light Canvas Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Shade 4 OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20150320 OTC MONOGRAPH NOT FINAL part352 Zaimu Holdings LLC DBA Vincent Longo Cosmetics OCTINOXATE; OCTOCRYLENE; AVOBENZONE 70; 40; 25 mg/mL; mg/mL; mg/mL E 20171231 69713-024_2beeaa52-05bf-4d0f-ac0b-c9e374a5f8d7 69713-024 HUMAN OTC DRUG Vincent Longo Ultra Light Canvas Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Shade 5 OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20150320 OTC MONOGRAPH NOT FINAL part352 Zaimu Holdings LLC DBA Vincent Longo Cosmetics OCTINOXATE; OCTOCRYLENE; AVOBENZONE 70; 40; 25 mg/mL; mg/mL; mg/mL E 20171231 69713-025_71c6b53f-43c7-4ac7-a446-68b2d5234c46 69713-025 HUMAN OTC DRUG Vincent Longo Ultra Light Canvas Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Shade 6 OCTINOXATE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20150320 OTC MONOGRAPH NOT FINAL part352 Zaimu Holdings LLC DBA Vincent Longo Cosmetics OCTINOXATE; OCTOCRYLENE; AVOBENZONE 70; 40; 25 mg/mL; mg/mL; mg/mL E 20171231 69715-100_2dcc7201-1db1-419a-8c07-d01433b1ce83 69715-100 HUMAN OTC DRUG Pedi-Derm Bum Zinc Oxide PASTE TOPICAL 20151005 OTC MONOGRAPH FINAL part347 Elixir Solutions, Inc. ZINC OXIDE 25 g/100g N 20191231 69716-010_684c48ad-80cf-4458-b0f1-924bec19ad11 69716-010 HUMAN OTC DRUG 28 Remedy Balancing Day Moisturizer Dimethicone CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 NoTS Co.,Ltd DIMETHICONE .45 mg/45mL N 20191231 69716-020_224f9b3f-6773-4638-8661-1a9c039ee9ef 69716-020 HUMAN OTC DRUG 28 Remedy Radiance Night Moisturizer Witch Hazel CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 NoTS Co Ltd WITCH HAZEL .00004 mg/45mL N 20181231 69716-030_58d7094e-fb56-4726-bb85-378aeae37f0d 69716-030 HUMAN OTC DRUG 28 Remedy Balancing Toner Witch Hazel CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 NoTS Co Ltd WITCH HAZEL 1 mg/100mL N 20181231 69716-040_7cce976c-cd3d-4637-a21a-34699287f654 69716-040 HUMAN OTC DRUG 28 Remedy Intensive Serum Witch Hazel CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 NoTS Co Ltd WITCH HAZEL .0003 mg/35mL N 20181231 69716-050_44ca8b69-a0e7-455a-b396-f37373bb0fb8 69716-050 HUMAN OTC DRUG 28 Remedy Eye Repair Concentrate Witch Hazel CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 NoTS Co Ltd WITCH HAZEL .00001 g/15g N 20181231 69716-060_22136294-7b6e-4d4e-8d05-386c15b3cecd 69716-060 HUMAN OTC DRUG 28 Remedy Repair Dimethicone CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 NoTS Co Ltd DIMETHICONE .3 g/30g N 20181231 69716-070_822221d3-5183-4afe-8e88-cea6cd130f83 69716-070 HUMAN OTC DRUG 28 Remedy Balancing Toner 10mL Salicylic Acid CREAM TOPICAL 20150901 UNAPPROVED DRUG OTHER NoTS Co Ltd SALICYLIC ACID .001 mg/10mL N 20181231 69716-080_f22b443d-5a29-448f-a793-484be1309478 69716-080 HUMAN OTC DRUG 28 Remedy Acne Pore Deep Cleanser Salicylic Acid GEL TOPICAL 20160102 OTC MONOGRAPH FINAL part333D NoTS Co.,Ltd SALICYLIC ACID .6 g/120mL N 20191231 69716-090_6d375cd9-4aa7-4e3f-88d8-e507233cb7b3 69716-090 HUMAN OTC DRUG 28 Remedy Aqua Brightening Peeling Allantoin GEL TOPICAL 20160102 UNAPPROVED DRUG OTHER NoTS Co.,Ltd ALLANTOIN .05 g/100mL N 20191231 69716-100_42bbb548-3047-4156-b157-8954c85256fa 69716-100 HUMAN OTC DRUG 28 Remedy Balancing Toner 100mL Witch Hazel CREAM TOPICAL 20160102 OTC MONOGRAPH FINAL part347 NoTS Co.,Ltd WITCH HAZEL 1 g/100mL N 20191231 69716-110_b5ab595a-7142-4fad-9429-70fa2a7e78f1 69716-110 HUMAN OTC DRUG 28 Remedy Repair 30g Dimethicone CREAM TOPICAL 20160102 OTC MONOGRAPH FINAL part347 NoTS Co.,Ltd DIMETHICONE .3 g/30g N 20191231 69716-120_7cc6e59e-2d08-4689-b3c7-cdf5b5b3d458 69716-120 HUMAN OTC DRUG AQUA BARRIER HYDRO SOFTENER Witch Hazel LIQUID TOPICAL 20160102 OTC MONOGRAPH FINAL part347 NoTS Co.,Ltd WITCH HAZEL .15 g/150mL N 20191231 69716-130_167fe7e6-4b67-443e-a9ee-2dabb844f1cb 69716-130 HUMAN OTC DRUG AQUA BARRIER LEVEL UP Witch Hazel CREAM TOPICAL 20160102 OTC MONOGRAPH FINAL part347 NoTS Co.,Ltd WITCH HAZEL .05 g/50g N 20191231 69716-140_29a5e69f-f218-45f0-9d3e-f4d8c33f22c2 69716-140 HUMAN OTC DRUG AQUA BARRIER LOTUS ESSENCE MIST Witch Hazel SPRAY TOPICAL 20160102 OTC MONOGRAPH FINAL part347 NoTS Co.,Ltd WITCH HAZEL .6 g/60mL N 20181231 69716-150_2d4c5bb0-4b02-4e04-ae4e-4f1c7b9182a3 69716-150 HUMAN OTC DRUG NOTS COMFORT CLEANSING Witch Hazel OIL TOPICAL 20160102 OTC MONOGRAPH FINAL part347 NoTS Co.,Ltd WITCH HAZEL .02 g/210mL N 20181231 69716-160_7fac46dc-3bc5-4382-9bfa-f07f856eb381 69716-160 HUMAN OTC DRUG NoTS LIP BALM Dimethicone STICK TOPICAL 20160201 OTC MONOGRAPH FINAL part347 NoTS Co.,Ltd DIMETHICONE .03 g/3.2g N 20181231 69716-170_cf434c9d-4d33-4447-b88b-cc0eeeaa46a5 69716-170 HUMAN OTC DRUG NoTS UV PROTECTION SUN OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, OCTISALATE CREAM TOPICAL 20160102 OTC MONOGRAPH NOT FINAL part352 NoTS Co.,Ltd OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE; OCTISALATE 4.76; 3.96; 3.5; 3.15 g/70g; g/70g; g/70g; g/70g N 20191231 69716-180_e8d0e9ee-43a4-4638-b004-5846950e9dfd 69716-180 HUMAN OTC DRUG NoTS 28 Remedy Acne Pore Deep Cleanser Salicylic Acid GEL TOPICAL 20160102 OTC MONOGRAPH FINAL part333D NoTS Co.,Ltd SALICYLIC ACID .1 g/20mL N 20181231 69716-190_f0e13e32-9d65-4417-80c1-4401345dcdb4 69716-190 HUMAN OTC DRUG NoTS Special Collagen Real Skin Mask Glycerin, Adenosine PATCH TOPICAL 20160701 UNAPPROVED DRUG OTHER NoTS Co.,Ltd GLYCERIN; ADENOSINE 1.12; .01 g/28g; g/28g N 20181231 69716-200_858c08a1-d020-421d-8c41-c10925a2f448 69716-200 HUMAN OTC DRUG NoTS Soothing Multi Ge l Mask Allantoin PATCH TOPICAL 20160701 UNAPPROVED DRUG OTHER NoTS Co.,Ltd ALLANTOIN .028 g/28g N 20181231 69716-210_713db3db-c0c7-4894-8590-1f01ed55df04 69716-210 HUMAN OTC DRUG NoTS Lavender Relax Daily Mask WITCH HAZEL PATCH TOPICAL 20160701 OTC MONOGRAPH FINAL part347 NoTS Co.,Ltd WITCH HAZEL .003 g/30g N 20181231 69716-220_8dbd2d0c-477f-4673-8fa4-795782328407 69716-220 HUMAN OTC DRUG NoTS Deep Water Wrapping Mask WITCH HAZEL PATCH TOPICAL 20160701 OTC MONOGRAPH FINAL part347 NoTS Co.,Ltd WITCH HAZEL .002 g/22g N 20181231 69716-230_6935b128-a713-462a-b2de-d5e87c7e80eb 69716-230 HUMAN OTC DRUG NoTS Li p Shimmer Gloss ADENOSINE LIPSTICK TOPICAL 20160701 UNAPPROVED DRUG OTHER NoTS Co.,Ltd ADENOSINE .001 g/3.5g N 20191231 69716-240_731a6083-9fab-4c58-9f1b-87db6936e05d 69716-240 HUMAN OTC DRUG Mel B DIMETHICONE CREAM TOPICAL 20161201 OTC MONOGRAPH FINAL part347 NoTS Co.,Ltd DIMETHICONE 1.5 g/50g N 20191231 69716-250_3fe3869e-13dd-48e7-9255-0adb3f1e6446 69716-250 HUMAN OTC DRUG Centella Scar Ylang Ylang Asiaticoside, Madecassic Acid, Asiatic Acid OINTMENT TOPICAL 20161201 UNAPPROVED DRUG OTHER NoTS Co.,Ltd ASIATICOSIDE; MADECASSIC ACID; ASIATIC ACID .06; .045; .045 g/15g; g/15g; g/15g N 20191231 69716-260_cce856ba-46cc-419a-85e1-331781ed3740 69716-260 HUMAN OTC DRUG NoTS Crystal CC Cushion No 21 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 NoTS Co.,Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.96; 1.05; .7 g/14g; g/14g; g/14g N 20191231 69716-270_e27d2614-351b-4683-b063-9e2fa936c5c5 69716-270 HUMAN OTC DRUG NoTS Crystal CC Cushion No 23 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 NoTS Co.,Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.96; 1.05; .7 g/14g; g/14g; g/14g N 20191231 69716-280_c34b05ea-6a32-43e0-aef1-0295fca2076a 69716-280 HUMAN OTC DRUG 28 Remedy Juvenile Sun BB Light Beige Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 NoTS Co.,Ltd OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 3.15; 3.06; 2.79 g/45mL; g/45mL; g/45mL N 20191231 69716-290_006eda76-6848-4075-bbec-00e855b4a660 69716-290 HUMAN OTC DRUG 28 Remedy Juvenile Sun BB Natural Beige Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 NoTS Co.,Ltd OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 3.15; 3.06; 2.79 g/45mL; g/45mL; g/45mL N 20191231 69716-300_7efdeff7-c434-4fc9-86dd-1c172cd64d4d 69716-300 HUMAN OTC DRUG NoTS Brightening Milk Mask Dimethicone PATCH TOPICAL 20161201 OTC MONOGRAPH FINAL part347 NoTS Co.,Ltd DIMETHICONE .5 g/20g N 20181231 69716-310_5dec8264-b6bf-4846-912f-4a0de9f53087 69716-310 HUMAN OTC DRUG Once Finishing OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 NoTS Co.,Ltd OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE .48; .32; .16; .15 g/8mL; g/8mL; g/8mL; g/8mL N 20181231 69718-154_dec3d93a-7a5a-4f5a-8e94-f55cce16f501 69718-154 HUMAN OTC DRUG Post peel Protectant Vitality Institute Hydrocortisone CREAM TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part348 Vitality Institute Medical Products HYDROCORTISONE 7.5 g/100mL N 20181231 69718-155_b9a1d098-9d70-40fd-a3ec-cac0522330db 69718-155 HUMAN OTC DRUG Sunscreen Broad Spectrum SPF 50 Vitality Institute Zinc Oxide, Octinoxate CREAM TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Vitality Institute Medical Products ZINC OXIDE; OCTINOXATE 10; 7.5 g/17.5mL; g/17.5mL N 20181231 69719-0001_013e1619-17bf-4e7f-8e49-a9d30ffa1320 69719-0001 HUMAN OTC DRUG Ultra Advantage Abrotanum (Artemisia Abrotanum), Anacardium Orientale, Baryta Muriatica, Calcarea Carbonica, Calcarea Phosphorica, Fucus Vesiculosus, Graphites, Helleborus Niger, Hypothalamus (Suis), Ignatia Amara, Lycopodium Clavatum, Magnesia Phosphorica, Secale Cornutum, Silicea, Thymus Serpyllum, Thyroidinum (Suis), Solidago Virgaurea LIQUID ORAL 20150428 UNAPPROVED HOMEOPATHIC Soza Weight Loss LLC ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; FUCUS VESICULOSUS; GRAPHITE; HELLEBORUS NIGER ROOT; SUS SCROFA HYPOTHALAMUS; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; THYMUS SERPYLLUM; SUS SCROFA THYROID; SOLIDAGO VIRGAUREA FLOWERING TOP 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69720-1001_12b1c712-fa09-31c0-e054-00144ff8d46c 69720-1001 HUMAN OTC DRUG SINGISO Red Ginseng TABLET ORAL 20150401 UNAPPROVED DRUG OTHER Sae In Dang Co., Ltd. ASIAN GINSENG .125 g/.8g N 20181231 69720-2001_36f2e13a-360a-582a-e054-00144ff88e88 69720-2001 HUMAN OTC DRUG SINGISO (0.8g) Red Ginseng TABLET ORAL 20160706 UNAPPROVED DRUG OTHER Sae In Dang Co., Ltd. ASIAN GINSENG 17.19 g/100g N 20181231 69720-3001_3b7fdf98-f3a7-1273-e054-00144ff88e88 69720-3001 HUMAN OTC DRUG SINGISO 101 (0.8g) Red Ginseng TABLET ORAL 20160831 UNAPPROVED DRUG OTHER Sae In Dang Co., Ltd. ASIAN GINSENG 17.19 g/100g N 20181231 69720-4001_3b7fdf98-f3b6-1273-e054-00144ff88e88 69720-4001 HUMAN OTC DRUG SINGISO 102 (0.8g) Red Ginseng TABLET ORAL 20160831 UNAPPROVED DRUG OTHER Sae In Dang Co., Ltd. ASIAN GINSENG 17.19 g/100g N 20181231 69721-001_07dcc7b4-c6c4-4d66-b84e-5eaf408acc84 69721-001 HUMAN OTC DRUG Somnapure Clinical Strength Diphenhydramine Hydrochloride TABLET, COATED ORAL 20150409 OTC MONOGRAPH FINAL part338 NutraClick, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 69721-002_0d8b8441-d5ef-4883-ac8c-680cdfa0cedd 69721-002 HUMAN OTC DRUG Somnapure Clinical Strength Diphenhydramine Hydrochloride TABLET, COATED ORAL 20150526 OTC MONOGRAPH FINAL part338 NutraClick, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 69722-733_1958a8a1-0047-5366-e054-00144ff8d46c 69722-733 HUMAN OTC DRUG So Fresh So Clean Mild Acne Treatment Salicylic Acid CLOTH TOPICAL 20150625 OTC MONOGRAPH FINAL part333D Global Beauty Care, Inc. SALICYLIC ACID .5 g/100g E 20171231 69722-734_1958a8a1-0046-5366-e054-00144ff8d46c 69722-734 HUMAN OTC DRUG Moderate Acne Treatment Salicylic Acid CLOTH TOPICAL 20150625 OTC MONOGRAPH FINAL part333D Global Beauty Care, Inc. SALICYLIC ACID 1 g/100g E 20171231 69722-735_195910e2-af2b-4127-e054-00144ff8d46c 69722-735 HUMAN OTC DRUG So Fresh So Clean Maximum Acne Treatment Salicylic Acid CLOTH TOPICAL 20150625 OTC MONOGRAPH FINAL part333D Global Beauty Care, Inc. SALICYLIC ACID 2 g/100g E 20171231 69724-112_1449ae1c-e938-4c96-b761-06b2f40191f4 69724-112 HUMAN PRESCRIPTION DRUG Sotalol hydrochloride Sotalol hydrochloride INJECTION INTRAVENOUS 20151015 NDA NDA022306 ALTATHERA Pharmaceuticals, LLC SOTALOL HYDROCHLORIDE 15 mg/mL Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 69725-001_1c60a5b3-c8fd-4d79-88e1-a7b111d7c85c 69725-001 HUMAN OTC DRUG Ultra Waterfall Cream Niacinamide, Adenosine CREAM TOPICAL 20150410 UNAPPROVED DRUG OTHER Lisz Kei NIACINAMIDE 1 mg/50mL E 20171231 69727-0001_8651504a-fb7d-43ab-8d95-bf04badcbb3f 69727-0001 HUMAN OTC DRUG SWL ULTRA ADVANTAGE Abrotanum, Anacardium orientale, Baryta carbonica, Calcarea carbonica, Calcarea phosphorica, Cinchona officinalis, Fucus vesiculosus, Glandula suprarenalis suis, Graphites, Helleborus niger, Hepar suis, Hypothalamus, Lycopodium clavatum, Magnesia phosphorica, Nicotinamidum, Pancreas suis, Solidago virgaurea, Thymolum, Thymus serpyllum, Thyroidinum LIQUID ORAL 20150515 UNAPPROVED HOMEOPATHIC ELTTAC Inc DBA SWL ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; CINCHONA OFFICINALIS BARK; FUCUS VESICULOSUS; SUS SCROFA ADRENAL GLAND; GRAPHITE; HELLEBORUS NIGER ROOT; PORK LIVER; BOS TAURUS HYPOTHALAMUS; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; NIACINAMIDE; SUS SCROFA PANCREAS; SOLIDAGO VIRGAUREA FLOWERING TOP; THYMOL; THYMUS SERPYLLUM; THYROID, UNSPECIFIED 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 8; 8; 8 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 69728-0001_11ac9e26-dd8c-5321-e054-00144ff8d46c 69728-0001 HUMAN OTC DRUG BICARUVAS ANTACID POWDER, FOR SOLUTION ORAL 20130423 OTC MONOGRAPH FINAL part331 PROSANA DISTRIBUCIONES, S.A. DE C.V. TARTARIC ACID; CALCIUM CARBONATE; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 2; 1; 15; 19 g/944mL; g/944mL; g/944mL; g/944mL E 20171231 69728-0002_2033b69b-6a37-233c-e054-00144ff88e88 69728-0002 HUMAN OTC DRUG BICARUVAS ANTACID POWDER, FOR SOLUTION ORAL 20130423 OTC MONOGRAPH FINAL part331 PROSANA DISTRIBUCIONES, S.A. DE C.V. TARTARIC ACID; CALCIUM CARBONATE; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 220; 50; 1827; 2452 mg/118mL; mg/118mL; mg/118mL; mg/118mL E 20171231 69728-0003_352f2b40-57e9-4379-e054-00144ff88e88 69728-0003 HUMAN OTC DRUG BICARUVAS ANTACID POWDER, FOR SOLUTION ORAL 20130423 OTC MONOGRAPH FINAL part331 PROSANA DISTRIBUCIONES, S.A. DE C.V. TARTARIC ACID; CALCIUM CARBONATE; CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 2; 1; 15; 19 g/944mL; g/944mL; g/944mL; g/944mL E 20171231 69728-0020_4c6e475a-5a5e-1ed4-e054-00144ff8d46c 69728-0020 HUMAN OTC DRUG VAPOUR RUB VAPOR RUB OINTMENT TOPICAL 20170405 OTC MONOGRAPH FINAL part341 PROSANA DISTRIBUCIONES, S.A. DE C.V. EUCALYPTUS OIL; CAMPHOR (SYNTHETIC); MENTHOL .6; 2.4; 1.3 g/50g; g/50g; g/50g N 20181231 69728-0030_4e7a2f36-ac25-248f-e054-00144ff88e88 69728-0030 HUMAN OTC DRUG VAPOUR RUB VAPOR RUB OINTMENT TOPICAL 20170405 OTC MONOGRAPH FINAL part341 PROSANA DISTRIBUCIONES, S.A. DE C.V. EUCALYPTUS OIL; CAMPHOR (SYNTHETIC); MENTHOL 1.2; 4.8; 2.6 g/100g; g/100g; g/100g N 20181231 69729-064_19ed56cd-e952-57b6-e054-00144ff8d46c 69729-064 HUMAN OTC DRUG Lakesia Clotrimazole CREAM TOPICAL 20150702 OTC MONOGRAPH FINAL part333C OPMX LLC CLOTRIMAZOLE 1 g/100g E 20171231 69729-080_2045df84-49db-7261-e054-00144ff8d46c 69729-080 HUMAN OTC DRUG Pentrexcilina Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, Polymyxin B OINTMENT TOPICAL 20120801 OTC MONOGRAPH FINAL part333B OPMX LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g E 20171231 69729-130_af7cf303-4bfa-4142-bfad-61f0b5f64ea7 69729-130 HUMAN OTC DRUG Buscapina Acetaminophen, Caffeine, Pyrilamine Maleate TABLET, COATED ORAL 20180105 OTC MONOGRAPH NOT FINAL part343 OPMX LLC ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20191231 69729-142_2636ca79-2810-4cfa-a5c7-724d5d652438 69729-142 HUMAN OTC DRUG COLDTAC ULTRA Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg TABLET ORAL 20180105 OTC MONOGRAPH FINAL part341 OPMX LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; 1/1 N 20191231 69729-143_0b906ca8-dca4-49de-ac47-75fb44449b3b 69729-143 HUMAN OTC DRUG COLDTAC Plus Acetaminophen, Phenylephrin Hydrochloride, Dextromethorphan Hydrobromide TABLET ORAL 20180105 OTC MONOGRAPH FINAL part341 OPMX LLC ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 325; 5; 15 mg/1; mg/1; mg/1 N 20191231 69729-253_487030a4-7b9a-2c4b-e054-00144ff88e88 69729-253 HUMAN OTC DRUG Hairklyn Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20101028 OTC MONOGRAPH FINAL part358G OPMX LLC PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 69730-301_8bcd403a-acbe-4cf9-90e0-2ed8062c6dd7 69730-301 HUMAN OTC DRUG RUBBING ALCOHOL 50 PERCENT ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A SAGE OIL LLC ISOPROPYL ALCOHOL 50 mL/100mL E 20171231 69730-302_3f2760b5-9c8c-4bd5-9626-63060a7a1396 69730-302 HUMAN OTC DRUG RUBBING ALCOHOL 50 PERCENT with Wintergreen ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A SAGE OIL, LLC ISOPROPYL ALCOHOL 50 mL/100mL E 20171231 69730-303_affbb70c-3c34-4897-a1e8-b1bb6874809e 69730-303 HUMAN OTC DRUG RUBBING ALCOHOL 70 PERCENT ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A SAGE OIL LLC ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 69730-304_3934c5de-6c07-4676-b992-f30c840a90a0 69730-304 HUMAN OTC DRUG RUBBING ALCOHOL 70 PERCENT with Wintergreen ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A SAGE OIL, LLC ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 69731-010_5bab63f4-e599-badc-e053-2a91aa0a1ef5 69731-010 HUMAN OTC DRUG Ultimate Topical Pain Relief Patch CAPSAICIN and MENTHOL, UNSPECIFIED FORM PATCH TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part348 G&N Enterprise,LLC MENTHOL, UNSPECIFIED FORM; CAPSAICIN 5; .0375 g/100g; g/100g N 20181231 69731-020_5bab6127-ce5e-1aed-e053-2a91aa0aaf65 69731-020 HUMAN OTC DRUG Ultimate Lidocaine Pain Relief Patch LIDOCAINE and MENTHOL, UNSPECIFIED FORM PATCH TOPICAL 20161001 OTC MONOGRAPH NOT FINAL part348 G&N Enterprise,LLC LIDOCAINE; MENTHOL, UNSPECIFIED FORM 4; 1 g/100g; g/100g N 20181231 69733-558_9168a381-ddef-4459-a994-4cc2e449dc83 69733-558 HUMAN OTC DRUG Antibacterial Moist Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part333E JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD BENZALKONIUM CHLORIDE .1 g/100g E 20171231 69733-566_20f735c6-7950-069b-e054-00144ff8d46c 69733-566 HUMAN OTC DRUG Acne Wipes SALICYLIC ACID SWAB TOPICAL 20150930 OTC MONOGRAPH FINAL part333D JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD SALICYLIC ACID 5 mg/1000mg E 20171231 69735-637_4934a7a8-4398-727a-e054-00144ff88e88 69735-637 HUMAN OTC DRUG Botanic Skincare Acne Defense Treatment SALICYLIC ACID LOTION TOPICAL 20150319 OTC MONOGRAPH FINAL part333D ElleGreen Health & Beauty Shop LLC SALICYLIC ACID 20 mg/mL N 20181231 69739-010_e4ce46e6-8f07-48e9-b599-d970ccf746ea 69739-010 HUMAN OTC DRUG SHIKATRI CLASS Pyrithione zinc SHAMPOO TOPICAL 20150301 OTC MONOGRAPH FINAL part358H 1004LABORATORY PYRITHIONE ZINC 3 mg/300mL E 20171231 69739-020_8f5d8bb6-0b80-4416-be12-44517001e965 69739-020 HUMAN OTC DRUG LONG WEAR GET OVER BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 1004LABORATORY TITANIUM DIOXIDE; ZINC OXIDE 3.37; 1.47 mg/30mL; mg/30mL E 20171231 69739-030_6d2853b7-c152-4d6f-b70c-69250f23e2b7 69739-030 HUMAN OTC DRUG ATOBOS Allantoin LOTION TOPICAL 20150301 OTC MONOGRAPH FINAL part347 1004LABORATORY ALLANTOIN .8 mg/160mL E 20171231 69739-040_9af64761-595e-4b34-8806-d186dc32c329 69739-040 HUMAN OTC DRUG ATOBOS Allantoin CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part347 1004LABORATORY ALLANTOIN .8 mg/160mL E 20171231 69739-050_0a6a78c9-3605-4af0-8623-ae6607e6495c 69739-050 HUMAN OTC DRUG ATOBOS WASH Allantoin SHAMPOO TOPICAL 20150301 OTC MONOGRAPH FINAL part347 1004LABORATORY ALLANTOIN 1.5 mg/300mL E 20171231 69739-060_b2851401-f27b-4251-822d-07aa318061f8 69739-060 HUMAN OTC DRUG ATOBOS BABY SUN Titanium Dioxide, Zinc oxide CREAM TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 1004LABORATORY TITANIUM DIOXIDE; ZINC OXIDE 5.62; 2.37 mg/50mL; mg/50mL E 20171231 69739-070_e3b51108-c762-4360-b88c-dc6e5464711d 69739-070 HUMAN OTC DRUG ATOBOS BABY AQUA SOOTHING Allantoin GEL TOPICAL 20150701 OTC MONOGRAPH FINAL part347 1004LABORATORY ALLANTOIN .8 mg/160mL E 20171231 69739-080_82da8324-5c14-415d-a85b-81c1ed4bf8a0 69739-080 HUMAN OTC DRUG ATOBOS CENTELLA BABY Allantoin LOTION TOPICAL 20150701 OTC MONOGRAPH FINAL part347 1004LABORATORY ALLANTOIN .8 mg/160mL E 20171231 69739-090_5962b7e1-e8b6-4e3b-80c9-1ab7aff97aaa 69739-090 HUMAN OTC DRUG ATOBOS CENTELLA BABY Allantoin CREAM TOPICAL 20150701 OTC MONOGRAPH FINAL part347 1004LABORATORY ALLANTOIN .8 mg/160mL E 20171231 69739-100_dfefefed-8549-42c3-ba17-252019848498 69739-100 HUMAN OTC DRUG ATOBOS CENTELLA BABY AQUA SOOTHING Allantoin GEL TOPICAL 20150701 OTC MONOGRAPH FINAL part347 1004LABORATORY ALLANTOIN .8 mg/160mL E 20171231 69739-110_2d119ad7-f975-497e-8183-0cabda2abb47 69739-110 HUMAN OTC DRUG ATOBOS CENTELLA AND WASH Allantoin SHAMPOO TOPICAL 20150701 OTC MONOGRAPH FINAL part347 1004LABORATORY ALLANTOIN 1.5 mg/300mL E 20171231 69739-120_f7880bce-ad38-4710-9cbf-336b8c9b2a2d 69739-120 HUMAN OTC DRUG ATOBOS CENTELLA BABY SUN Titanium Dioxide, Zinc oxide CREAM TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 1004LABORATORY TITANIUM DIOXIDE; ZINC OXIDE 5.62; 2.37 mg/50mL; mg/50mL E 20171231 69740-212_bccd9337-11f5-45f6-b714-842b8ca36731 69740-212 HUMAN OTC DRUG I.V. Prep Antiseptic Wipe ISOPROPYL ALCOHOL SOLUTION TOPICAL 19991001 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew, Medical Ltd ISOPROPYL ALCOHOL .57 1/1 N 20181231 69740-302_668b1f3c-6012-4e1d-99ba-88841dd9afaf 69740-302 HUMAN OTC DRUG Secura Total Body Foam Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew Medical Ltd. BENZETHONIUM CHLORIDE .013 1/mL N 20181231 69740-303_668b1f3c-6012-4e1d-99ba-88841dd9afaf 69740-303 HUMAN OTC DRUG Secura Total Body Foam Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew Medical Ltd. BENZETHONIUM CHLORIDE .013 1/mL N 20181231 69740-304_3d7f873d-7604-4e2f-9621-109ca2160279 69740-304 HUMAN OTC DRUG Secura Personal Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew Medical Ltd BENZETHONIUM CHLORIDE 1.3 mg/mL N 20191231 69740-305_3d7f873d-7604-4e2f-9621-109ca2160279 69740-305 HUMAN OTC DRUG Secura Personal Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew Medical Ltd BENZETHONIUM CHLORIDE 1.3 mg/mL N 20191231 69740-308_741d5f32-12ec-4170-8ac4-34159856590b 69740-308 HUMAN OTC DRUG Secura Moisturizing Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew Medical Ltd BENZETHONIUM CHLORIDE 1.3 ug/mL N 20181231 69740-309_741d5f32-12ec-4170-8ac4-34159856590b 69740-309 HUMAN OTC DRUG Secura Moisturizing Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 20030801 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew Medical Ltd BENZETHONIUM CHLORIDE 1.3 ug/mL N 20181231 69740-311_aa278fb5-248f-4c91-8b05-1a8a075ec67c 69740-311 HUMAN OTC DRUG Secura Protective ZINC OXIDE CREAM TOPICAL 20030801 OTC MONOGRAPH FINAL part347 Smith & Nephew Medical Ltd ZINC OXIDE 100 mg/g N 20181231 69740-312_aa278fb5-248f-4c91-8b05-1a8a075ec67c 69740-312 HUMAN OTC DRUG Secura Protective ZINC OXIDE CREAM TOPICAL 20030801 OTC MONOGRAPH FINAL part347 Smith & Nephew Medical Ltd ZINC OXIDE 100 mg/g N 20181231 69740-315_9bf6901e-68fb-45e3-a2bd-6b9fb1b3c340 69740-315 HUMAN OTC DRUG Secura Protective petrolatum OINTMENT TOPICAL 20030801 OTC MONOGRAPH FINAL part347 Smith & Nephew Medical Ltd PETROLATUM 987.89 mg/g N 20181231 69740-315_cf7145c4-74e2-4c0f-8f92-c3bb6952e299 69740-315 HUMAN OTC DRUG Secura Protective petrolatum OINTMENT TOPICAL 20030801 OTC MONOGRAPH FINAL part347 Smith & Nephew Medical Ltd PETROLATUM 987.89 mg/g N 20181231 69740-316_9bf6901e-68fb-45e3-a2bd-6b9fb1b3c340 69740-316 HUMAN OTC DRUG Secura Protective petrolatum OINTMENT TOPICAL 20030801 OTC MONOGRAPH FINAL part347 Smith & Nephew Medical Ltd PETROLATUM 987.89 mg/g N 20181231 69740-322_23f89cb2-a43f-4a98-a679-49bf19cba451 69740-322 HUMAN OTC DRUG Secura Dimethicone Protectant DIMETHICONE CREAM TOPICAL 20050801 OTC MONOGRAPH FINAL part347 Smith & Nephew Medical Ltd DIMETHICONE 50 mg/g N 20181231 69740-324_faa8dafb-02c6-4c93-bf00-8576f5db75b9 69740-324 HUMAN OTC DRUG Secura Extra Protective ZINC OXIDE CREAM TOPICAL 20030801 OTC MONOGRAPH FINAL part347 Smith & Nephew Medical Ltd ZINC OXIDE 306.1 mg/g N 20181231 69740-325_faa8dafb-02c6-4c93-bf00-8576f5db75b9 69740-325 HUMAN OTC DRUG Secura Extra Protective Cream ZINC OXIDE CREAM TOPICAL 20030801 OTC MONOGRAPH FINAL part347 Smith & Nephew Medical Ltd ZINC OXIDE 306.1 mg/g N 20181231 69740-328_04879b8a-e281-44e2-8b9b-96b51c4919e1 69740-328 HUMAN OTC DRUG Secura Antifungal Greaseless MICONAZOLE NITRATE CREAM TOPICAL 20030801 OTC MONOGRAPH FINAL part333C Smith & Nephew Medical Ltd MICONAZOLE NITRATE 20 mg/g N 20181231 69740-329_04879b8a-e281-44e2-8b9b-96b51c4919e1 69740-329 HUMAN OTC DRUG Secura Antifungal Extra Thick MICONAZOLE NITRATE CREAM TOPICAL 20030801 OTC MONOGRAPH FINAL part333C Smith & Nephew Medical Ltd MICONAZOLE NITRATE 20 mg/g N 20181231 69740-341_604d4385-1cb4-4316-e053-2a91aa0ae702 69740-341 HUMAN OTC DRUG Secura EPC Skin Care Starter Kit ZINC OXIDE, BENZETHONIUM CHLORIDE KIT 20030801 OTC MONOGRAPH FINAL part347 Smith & Nephew Medical Ltd N 20181231 69740-342_604d4385-1ccd-4316-e053-2a91aa0ae702 69740-342 HUMAN OTC DRUG Secura Starter Kit BENZETHONIUM CHLORIDE,PETROLATUM KIT 20030801 OTC MONOGRAPH FINAL part347 Smith & Nephew Medical Ltd N 20181231 69740-343_604d4385-1c7c-4316-e053-2a91aa0ae702 69740-343 HUMAN OTC DRUG Secura Personal Skin Care Kit BENZETHONIUM CHLORIDE,PETROLATUM KIT 20030801 OTC MONOGRAPH FINAL part347 Smith & Nephew Medical Ltd N 20181231 69740-344_604d4385-1c99-4316-e053-2a91aa0ae702 69740-344 HUMAN OTC DRUG Secura Two Step Kit benzethonium chloride and zinc oxide cream KIT TOPICAL 20030801 OTC MONOGRAPH FINAL part347 Smith & Nephew, Medical Ltd. N 20181231 69740-490_8814334f-33aa-4190-be4b-4a48853aca12 69740-490 HUMAN OTC DRUG Dermal Wound Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 19940401 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew Medical Ltd. BENZETHONIUM CHLORIDE 1.3 g/981mL N 20181231 69740-492_8814334f-33aa-4190-be4b-4a48853aca12 69740-492 HUMAN OTC DRUG Dermal Wound Cleanser BENZETHONIUM CHLORIDE SPRAY TOPICAL 19910401 OTC MONOGRAPH NOT FINAL part333A Smith & Nephew Medical Ltd. BENZETHONIUM CHLORIDE 1.3 g/981mL N 20181231 69741-1001_13d11ae7-65b5-09f8-e054-00144ff8d46c 69741-1001 HUMAN OTC DRUG Nature and Health Beauty (Moisturizing Cream, Whitening Cream) Mineral Oil and Glycerin CREAM TOPICAL 20150416 UNAPPROVED DRUG OTHER Nature and Health Beauty Co., Ltd. MINERAL OIL; GLYCERIN 1.2; 1.2 g/120g; g/120g E 20171231 69741-2001_765eca20-c4d2-457e-9d8a-1fc5e5a5ad54 69741-2001 HUMAN OTC DRUG Nature and Health Beauty (Moisturizing Cream, Whitening Cream) (Mineral Oil and Glycerin) mineral oil CREAM TOPICAL 20160313 UNAPPROVED DRUG OTHER Nature and Health Beauty Co., Ltd. MINERAL OIL; GLYCERIN 1.2; 1.2 g/120g; g/120g E 20171231 69741-3001_2ea9b21c-18e7-0a8a-e054-00144ff8d46c 69741-3001 HUMAN OTC DRUG Nature and Health Beauty (Moisturizing Cream, Whitening Cream) (Mineral Oil and Glycerin) mineral oil CREAM TOPICAL 20160323 UNAPPROVED DRUG OTHER Nature and Health Beauty Co., Ltd. MINERAL OIL; GLYCERIN 1; 1 g/100mL; g/100mL E 20171231 69743-513_07962bd1-ef61-1505-e054-00144ff8d46c 69743-513 HUMAN OTC DRUG RHEMU RHEMU ANALGESIC CREAM TOPICAL 20141215 OTC MONOGRAPH NOT FINAL part348 Galxee, Inc. MENTHOL; METHYL SALICYLATE .07; .1 g/g; g/g N 20181231 69744-0201_13ded300-ebf4-520c-e054-00144ff8d46c 69744-0201 HUMAN OTC DRUG TOUCH Sanitizing Germ Block, Unscented, 1oz (28.35g) benzalkonium chloride AEROSOL, SPRAY TOPICAL 20150801 20200415 OTC MONOGRAPH NOT FINAL part333A Relevo, Inc. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 69744-0202_13ded300-ebf4-520c-e054-00144ff8d46c 69744-0202 HUMAN OTC DRUG TOUCH Sanitizing Germ Block, Mint Green Tea Aloe, 1oz (28.35g) benzalkonium chloride AEROSOL, SPRAY TOPICAL 20150801 20200415 OTC MONOGRAPH NOT FINAL part333A Relevo, Inc. BENZALKONIUM CHLORIDE .13 g/100g E 20171231 69744-0203_13ded300-ebf4-520c-e054-00144ff8d46c 69744-0203 HUMAN OTC DRUG TOUCH Sanitizing Germ Block, Tropical Breeze, 1oz (28.35g) benzalkonium chloride AEROSOL, SPRAY TOPICAL 20150801 20200415 OTC MONOGRAPH NOT FINAL part333A Relevo, Inc. BENZALKONIUM CHLORIDE .13 g/100g E 20171231 69744-0204_13ded300-ebf4-520c-e054-00144ff8d46c 69744-0204 HUMAN OTC DRUG TOUCH Sanitizing Germ Block, Ocean Mist, 1oz (28.35g) benzalkonium chloride AEROSOL, SPRAY TOPICAL 20150801 20200415 OTC MONOGRAPH NOT FINAL part333A Relevo, Inc. BENZALKONIUM CHLORIDE .13 g/100g E 20171231 69745-010_2e3958f9-cc06-472e-b7e0-ee623a2330e9 69745-010 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride GEL DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69745-011_4ce652d7-6a64-42ca-97ef-f31599f1e2fd 69745-011 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride GEL DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69745-012_1299bddf-675c-4427-a9b3-76541615b916 69745-012 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride GEL DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69745-013_e3ac35fd-d9de-4415-a6aa-e44bc06445f5 69745-013 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride GEL DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69745-014_19d59643-9565-42af-ba66-4dc708a89212 69745-014 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride GEL DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69745-015_abb91ec0-98f8-427d-8534-d58f734145e4 69745-015 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride GEL DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69745-016_f3541c4c-8c92-4851-93c0-58d16c92bd52 69745-016 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride GEL DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69745-017_a44ffd4a-2878-4d6d-8263-1333ea46f6f7 69745-017 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride GEL DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69745-018_c369840b-38cb-4337-bd5e-303db0dcba56 69745-018 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride GEL DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69745-019_6ef8bae0-84eb-46a1-a37d-27eea99ae736 69745-019 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride GEL DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 5.6 g/454g N 20181231 69745-030_fecf231b-b02b-44c2-8030-26290b08ef5d 69745-030 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride AEROSOL, FOAM DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 1.5375 g/125g E 20171231 69745-031_10d10ea0-151a-4820-a649-559bdc70ed66 69745-031 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride AEROSOL, FOAM DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 1.5375 g/125g E 20171231 69745-032_740d4dc6-1cdd-4dc0-bfa4-ffdfef17df5c 69745-032 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride AEROSOL, FOAM DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 1.5375 g/125g E 20171231 69745-033_57e94ee4-2071-4b36-972b-93ff43ca74cd 69745-033 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride AEROSOL, FOAM DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 1.5375 g/125g E 20171231 69745-034_9159f70a-c43c-4819-a9f7-85863da9bad1 69745-034 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride AEROSOL, FOAM DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 1.5375 g/125g E 20171231 69745-035_3ec24528-87fe-4802-82e2-7dcfbdda68dd 69745-035 HUMAN PRESCRIPTION DRUG MS APF Sodium Fluoride AEROSOL, FOAM DENTAL 20141001 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 1.5375 g/125g E 20171231 69745-040_a17477b7-e88d-42c0-9098-cd67ef5ad564 69745-040 HUMAN PRESCRIPTION DRUG MS Neutral pH Sodium Fluoride GEL DENTAL 20150401 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC SODIUM FLUORIDE 4.086 g/454g N 20181231 69745-050_cfec08d6-f950-4f58-b90d-4e9c3fff69a6 69745-050 HUMAN PRESCRIPTION DRUG MS HEMOSTATIC Aluminum Chloride SOLUTION DENTAL 20140901 UNAPPROVED DRUG OTHER M&S Dental Supply Co., LLC ALUMINUM CHLORIDE 7500 mg/30mL N 20181231 69745-060_60c6771b-512f-47ec-88ce-2c8ff5e3ccc8 69745-060 HUMAN OTC DRUG MS Topical Anesthetic Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 M&S Dental Supply Co., LLC BENZOCAINE 200 mg/g N 20181231 69745-061_e89061ad-1498-4838-b50c-49aa877009ab 69745-061 HUMAN OTC DRUG MS Topical Anesthetic Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 M&S Dental Supply Co., LLC BENZOCAINE 200 mg/g N 20181231 69745-062_033e81d6-df92-4544-9cb6-82b2e1028fd7 69745-062 HUMAN OTC DRUG MS Topical Anesthetic Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 M&S Dental Supply Co., LLC BENZOCAINE 200 mg/g N 20181231 69745-063_860a9e1c-85f8-4a0e-8a17-ddeb64ff0b21 69745-063 HUMAN OTC DRUG MS Topical Anesthetic Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 M&S Dental Supply Co., LLC BENZOCAINE 200 mg/g N 20181231 69745-064_fbf998a5-2ca9-4d0f-a1d9-c0a0a1cc7bfd 69745-064 HUMAN OTC DRUG MS Topical Anesthetic Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 M&S Dental Supply Co., LLC BENZOCAINE 200 mg/g N 20181231 69745-065_b79fbac8-2a90-4c2f-b67e-538ea5ea3456 69745-065 HUMAN OTC DRUG MS Topical Anesthetic Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 M&S Dental Supply Co., LLC BENZOCAINE 200 mg/g N 20181231 69745-066_e80b9077-40c7-4f92-a091-3cbca5765527 69745-066 HUMAN OTC DRUG MS Topical Anesthetic Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 M&S Dental Supply Co., LLC BENZOCAINE 200 mg/g N 20181231 69747-040_63118834-3d0d-795f-e053-2a91aa0ad67d 69747-040 HUMAN OTC DRUG Greencaine Blast Lidocaine GEL TOPICAL 20180118 OTC MONOGRAPH NOT FINAL part348 ALMA Laboratories, Inc. LIDOCAINE 40 mg/g N 20191231 69748-641_48a9d13b-d078-00c8-e054-00144ff8d46c 69748-641 HUMAN OTC DRUG NeutraCure Restore Benzoyl Peroxide CREAM TOPICAL 20150410 OTC MONOGRAPH FINAL part333D Neutracure BENZOYL PEROXIDE 50 mg/mL N 20181231 69749-640_482e2384-ef1a-01c7-e054-00144ff88e88 69749-640 HUMAN OTC DRUG Vasseur Skincare Day Matte SPF30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150407 OTC MONOGRAPH NOT FINAL part352 Vasseur International Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/g; mg/g N 20181231 69750-001_1f3f851c-0c92-4ef2-968e-c39caa3b3f6e 69750-001 HUMAN OTC DRUG Vertra Elemental Resistance Water Resistant Sunscreen Octyl Methoxycinnamate, Oxybenzone, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20150518 OTC MONOGRAPH NOT FINAL part352 Vertra (Aust) Pty Ltd OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 4.8; 4; 5; 7.9 g/80g; g/80g; g/80g; g/80g N 20181231 69752-100_326aadc1-6944-3f49-e054-00144ff88e88 69752-100 HUMAN OTC DRUG Soft and Dri Soft Glide Solid Aluminum Zirconium Tricholrohydrex STICK TOPICAL 20151113 OTC MONOGRAPH FINAL part350 The Village Company ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 200 mg/g E 20171231 69752-101_321df736-5ce0-5e6e-e054-00144ff8d46c 69752-101 HUMAN OTC DRUG Soft and Dri Soft Scent Aluminum Chlorohydrate AEROSOL TOPICAL 20151113 OTC MONOGRAPH FINAL part350 The Village Company ALUMINUM CHLOROHYDRATE 200 mg/g N 20181231 69752-102_326eb64f-6cb1-4d0a-e054-00144ff88e88 69752-102 HUMAN OTC DRUG Soft and Dri drigel Aluminum Zirconium Octocholrohydrex STICK TOPICAL 20151113 OTC MONOGRAPH FINAL part350 The Village Company ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY 164 mg/g E 20171231 69752-103_321df736-5ce0-5e6e-e054-00144ff8d46c 69752-103 HUMAN OTC DRUG Soft and Dri Cool and Clean Aluminum Chlorohydrate AEROSOL TOPICAL 20151113 OTC MONOGRAPH FINAL part350 The Village Company ALUMINUM CHLOROHYDRATE 250 mg/g N 20181231 69752-121_31e156cb-63aa-036d-e054-00144ff8d46c 69752-121 HUMAN OTC DRUG Tegrin PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20150701 OTC MONOGRAPH FINAL part358H The Village Company PYRITHIONE ZINC 1.2 g/mL E 20171231 69753-002_b87c6ee4-360c-4315-97e9-d3b17b7cec38 69753-002 HUMAN OTC DRUG Element 47 Face and Body Acne Treatment Salicylic Acid SPRAY TOPICAL 20150410 OTC MONOGRAPH FINAL part333D Worldceuticals, LLC SALICYLIC ACID 5 mg/mL N 20181231 69756-001_e34a0038-eec5-4823-88bf-21e6e32a033a 69756-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20150401 UNAPPROVED MEDICAL GAS California O2 Services Inc OXYGEN 99 L/100L E 20171231 69757-101_63cf318c-ad19-4c3f-81eb-e2e694f2e0eb 69757-101 HUMAN OTC DRUG SCENTLOK TECHNOLOGIES ANTIPERSPIRANT ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY GEL TOPICAL 20150502 OTC MONOGRAPH FINAL part350 ALS ENTERPRISES INC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 15 g/100g E 20171231 69758-322_fb99a908-2ab5-44f8-81ab-ca776c651358 69758-322 HUMAN OTC DRUG HemoTreat white petrolatum, lanolin, hard fat, camphor CREAM TOPICAL 20150515 OTC MONOGRAPH FINAL part346 Global Treat srl PETROLATUM; LANOLIN; FAT, HARD; CAMPHOR (SYNTHETIC) .213; .212; .426; .025 g/g; g/g; g/g; g/g E 20171231 69758-325_30cfc083-ecf0-45d7-a37f-8d41143f9ead 69758-325 HUMAN OTC DRUG HemoTreat white petrolatum, lanolin, hard fat, camphor CREAM TOPICAL 20151220 OTC MONOGRAPH FINAL part346 Global Treat srl PETROLATUM; LANOLIN; FAT, HARD; CAMPHOR (SYNTHETIC) .213; .212; .426; .025 g/mL; g/mL; g/mL; g/mL E 20171231 69758-328_4cd4c898-fedb-721f-e054-00144ff88e88 69758-328 HUMAN OTC DRUG HemoTreat camphor SUPPOSITORY RECTAL 20161031 OTC MONOGRAPH FINAL part346 Global Treat srl CAMPHOR (SYNTHETIC) .025 g/g N 20181231 69760-0001_59446839-50fc-46a1-8a3e-b18297451457 69760-0001 HUMAN OTC DRUG GoutFlex Gout Symptom Formula Ammonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, Urtica urens LIQUID ORAL 20150928 UNAPPROVED HOMEOPATHIC Nutra Vista Health LLC. AMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR BARK; FRAXINUS EXCELSIOR LEAF; LEDUM PALUSTRE TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 69761-006_5f86eff2-9604-67e6-e053-2991aa0a559c 69761-006 HUMAN PRESCRIPTION DRUG Estradiol estradiol PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC ESTRADIOL 6 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 69761-010_559cc5e9-0110-4e6d-a343-156f6046b3b5 69761-010 HUMAN PRESCRIPTION DRUG Estradiol estradiol PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC ESTRADIOL 10 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 69761-012_63769634-2bb8-4ee0-bc39-5ed7878c1ac6 69761-012 HUMAN PRESCRIPTION DRUG Estradiol estradiol PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC ESTRADIOL 12.5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 69761-015_49372cf6-fa76-4aac-974c-eb0e353b1712 69761-015 HUMAN PRESCRIPTION DRUG Estradiol estradiol PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC ESTRADIOL 15 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 69761-018_5e95ab24-d9b9-482a-bfe5-86ea5ffc7d78 69761-018 HUMAN PRESCRIPTION DRUG Estradiol estradiol PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC ESTRADIOL 18 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 69761-020_b6bd3dc1-6fa5-4305-bfb6-78c8d565ef3a 69761-020 HUMAN PRESCRIPTION DRUG Estradiol estradiol PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC ESTRADIOL 20 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 69761-022_f39ab225-e0f3-4361-a2fb-87e7ddb85449 69761-022 HUMAN PRESCRIPTION DRUG Estradiol estradiol PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC ESTRADIOL 22 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 69761-025_8e0e45d9-56f2-48b3-b8d8-f876209cac49 69761-025 HUMAN PRESCRIPTION DRUG Estradiol estradiol PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC ESTRADIOL 25 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 69761-110_d746791f-9e2f-4ef5-9776-d28e3ae617b9 69761-110 HUMAN PRESCRIPTION DRUG Testosterone testosterone PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC TESTOSTERONE 100 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 69761-120_bd0529c5-e20f-4ea3-bbcd-483242cf0ddd 69761-120 HUMAN PRESCRIPTION DRUG Testosterone testosterone PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC TESTOSTERONE 200 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 69761-125_e669ead0-34c1-4a2e-99fb-c1eafeb8c9ed 69761-125 HUMAN PRESCRIPTION DRUG Testosterone testosterone PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC TESTOSTERONE 25 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 69761-137_11a9e215-d4da-4cf6-85cd-ba5a5de909a5 69761-137 HUMAN PRESCRIPTION DRUG Testosterone testosterone PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC TESTOSTERONE 37.5 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 69761-150_14ed436a-46da-47df-9aa7-24b47e937425 69761-150 HUMAN PRESCRIPTION DRUG Testosterone testosterone PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC TESTOSTERONE 50 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 69761-187_412a021a-943d-4f73-b7c1-3632f4a1ab35 69761-187 HUMAN PRESCRIPTION DRUG Testosterone testosterone PELLET ORAL 20150901 UNAPPROVED DRUG OTHER Qualgen LLC TESTOSTERONE 87.5 mg/1 Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient] N 20181231 69761-222_5df9393e-b51f-1a8e-e053-2a91aa0a0907 69761-222 HUMAN PRESCRIPTION DRUG Testosterone / Anastrozole Testosterone / Anastrozole PELLET ORAL 20171114 UNAPPROVED DRUG OTHER Qualgen LLC (1,2,6,7-3H)TESTOSTERONE; ANASTROZOLE 200; 20 mg/1; mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 69764-001_d2cfcb60-ddfd-447b-9fed-c6b20538a9f2 69764-001 HUMAN OTC DRUG Gene 16 Whitening Factor Allantoin TABLET, SOLUBLE TOPICAL 20140925 OTC MONOGRAPH FINAL part347 Shanghai Liang Liang International Inc ALLANTOIN .5 mg/100mg E 20171231 69767-101_b7e71848-c35b-40d0-b15a-c880f4367e6c 69767-101 HUMAN OTC DRUG Clerian Anti-Hairloss Salicylic Acid, Niacinamide LIQUID TOPICAL 20150410 UNAPPROVED DRUG OTHER CLERIAN, INC. SALICYLIC ACID; NIACINAMIDE .5; .3 1/5mL; 1/5mL E 20171231 69767-102_b75f2ebf-1b9c-4a5e-9254-90187444cd74 69767-102 HUMAN OTC DRUG Clerian H Salicylic Acid, Niacinamide LIQUID TOPICAL 20150420 UNAPPROVED DRUG OTHER CLERIAN, INC. SALICYLIC ACID; NIACINAMIDE .2; .3 1/5mL; 1/5mL E 20171231 69767-103_29fa21bf-4671-4665-a7b0-d98c3bc41bda 69767-103 HUMAN OTC DRUG Clerian Salicylic Acid, Niacinamide SHAMPOO TOPICAL 20150420 UNAPPROVED DRUG OTHER CLERIAN, INC. NIACINAMIDE; SALICYLIC ACID .2; .1 1/100mL; 1/100mL E 20171231 69768-001_84308edf-c37e-47d2-ad44-5e2b55eb5fcc 69768-001 HUMAN OTC DRUG Edge GAMBIR, MUCUNA PRURIENS SEED, ERYTHROXYLUM CATUABA BARK, EPIMEDIUM GRANDIFLORUM TOP, TURNERA DIFFUSA LEAF, GINKGO, ELEUTHERO, PANAX NOTOGINSENG ROOT,TRIBULUS TERRESTRIS FRUIT GEL TOPICAL 20150401 UNAPPROVED DRUG OTHER Sensuous Pty Ltd GAMBIR; MUCUNA PRURIENS SEED; ERYTHROXYLUM CATUABA BARK; EPIMEDIUM GRANDIFLORUM TOP; TURNERA DIFFUSA LEAF; GINKGO; ELEUTHERO; PANAX NOTOGINSENG ROOT; TRIBULUS TERRESTRIS FRUIT 2; .025; .025; .012; .124; .124; .124; .018; .124 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g; mg/g; mg/g; mg/g E 20171231 69769-101_14798d58-d3e9-0272-e054-00144ff8d46c 69769-101 HUMAN OTC DRUG SOLEIL FORTE MULTI OCTINOXATE, OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE LOTION TOPICAL 20150424 OTC MONOGRAPH NOT FINAL part352 LINEX HEALTH & BEAUTY HOMOSALATE; OCTINOXATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 5; 7.5; 5; 3; 2.75 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 69769-102_147b174d-c3fe-3ca7-e054-00144ff88e88 69769-102 HUMAN OTC DRUG DD TZ FORTE TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20150429 OTC MONOGRAPH FINAL part352 LINEX HEALTH & BEAUTY TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE 2; 8; 7.5; 5 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 69771-001_5e8582e0-f856-4301-897d-c6e5d35348d8 69771-001 HUMAN OTC DRUG GeriGentle Hand Wipes Alcohol GEL TOPICAL 20150616 OTC MONOGRAPH NOT FINAL part333E Geri-Gentle Corporation ALCOHOL 69.5 g/100g N 20181231 69771-002_6401b218-b7ca-2e2d-e053-2991aa0ae9c1 69771-002 HUMAN OTC DRUG Antimicrobial Alcohol Hand ALCOHOL PATCH TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part333E Geri-Gentle Corporation ALCOHOL 65.9 g/100g N 20191231 69771-003_6401da8a-8cf4-72f6-e053-2991aa0ad5e0 69771-003 HUMAN OTC DRUG Alcohol Prep ISOPROPYL ALCOHOL PATCH TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part333A Geri-Gentle Corporation ISOPROPYL ALCOHOL 70 g/100g N 20191231 69771-105_da048f94-f03b-4722-a719-d7429be90687 69771-105 HUMAN OTC DRUG Gerigentle-Vitamins A and D Petrolatum OINTMENT TOPICAL 20150115 OTC MONOGRAPH FINAL part347 Geri-Gentle Corporation PETROLATUM .93 g/g N 20191231 69771-106_b3708696-ff3f-495d-85e0-ab18ab8297ac 69771-106 HUMAN OTC DRUG Gerigentle-Bacitracin zinc Bacitracin Zinc OINTMENT TOPICAL 20150115 OTC MONOGRAPH FINAL part333B Geri-Gentle Corporation BACITRACIN ZINC 500 [USP'U]/g N 20191231 69771-107_f10a159f-6434-48cf-b67d-684b9a67b370 69771-107 HUMAN OTC DRUG Gerigentle-Good morning Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20150115 OTC MONOGRAPH FINAL part355 Geri-Gentle Corporation SODIUM MONOFLUOROPHOSPHATE .1 g/100g N 20191231 69771-108_e78720ac-90b4-4ff0-aba4-8c4e8d0cc88a 69771-108 HUMAN OTC DRUG Gerigard-Skin Protectant Zinc Oxide OINTMENT TOPICAL 20090115 OTC MONOGRAPH FINAL part347 Geri-Gentle Corporation ZINC OXIDE 1.8 g/100g N 20191231 69772-019_47a64219-8df3-21e8-e054-00144ff88e88 69772-019 HUMAN OTC DRUG Vitacilina Neomycin OINTMENT TOPICAL 20150515 OTC MONOGRAPH FINAL part333B Teresa Cecena DBA Genesis NEOMYCIN SULFATE 3.5 mg/g N 20181231 69772-020_178ee670-cf68-5c8f-e054-00144ff88e88 69772-020 HUMAN OTC DRUG Stefano Spazio Aluminum Chlorohydrate LIQUID TOPICAL 20150602 OTC MONOGRAPH FINAL part350 Teresa Cecena DBA Genesis ALUMINUM CHLOROHYDRATE 25 g/100mL E 20171231 69772-030_17916c37-b0ae-4fd9-e054-00144ff8d46c 69772-030 HUMAN OTC DRUG Stefano Midnight Aluminum Chlorohydrate LIQUID TOPICAL 20150602 OTC MONOGRAPH FINAL part350 Teresa Cecena DBA Genesis ALUMINUM CHLOROHYDRATE 50 g/100mL E 20171231 69772-040_17919888-6131-46d2-e054-00144ff88e88 69772-040 HUMAN OTC DRUG Stefano Gladius Roll-on Aluminum Chlorohydrate LIQUID TOPICAL 20150602 OTC MONOGRAPH FINAL part350 Teresa Cecena DBA Genesis ALUMINUM CHLOROHYDRATE 25 g/100mL E 20171231 69772-050_2a8271c8-48eb-09a4-e054-00144ff8d46c 69772-050 HUMAN OTC DRUG STEFANO ROYAL ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20160129 OTC MONOGRAPH FINAL part350 TERESA CECENA DBA GENESIS ALUMINUM CHLOROHYDRATE 25 g/50mL E 20171231 69772-102_18a909f2-c5d1-2c42-e054-00144ff88e88 69772-102 HUMAN OTC DRUG HEAD AND SHOULDER MEN OLD SPICE PYRITHIONE ZINC LOTION/SHAMPOO TOPICAL 20150616 OTC MONOGRAPH FINAL part358H Teresa Cecena DBA Genesis PYRITHIONE ZINC .01 g/mL E 20171231 69772-105_4d648add-ae3a-3716-e054-00144ff88e88 69772-105 HUMAN OTC DRUG COLGATE TRILPLE ACCION SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20170417 OTC MONOGRAPH FINAL part355 GENESIS IMPORTS & EXPORTS LLC SODIUM FLUORIDE .32 mg/mL N 20181231 69772-110_616b5f96-23f5-0c9a-e053-2a91aa0ae17f 69772-110 HUMAN OTC DRUG Nieva Satin ALUMINUM CHLOROHYDRATE LIQUID TOPICAL 20161102 OTC MONOGRAPH FINAL part350 Genesis Imports & Exports LLC ALUMINUM CHLOROHYDRATE 12.5 g/100mL N 20181231 69772-125_1686d03c-efbb-6d6e-e054-00144ff88e88 69772-125 HUMAN OTC DRUG DERMAN ANTIFUNGAL ZINC UNDECYLENATE CREAM TOPICAL 20150514 OTC MONOGRAPH FINAL part333C Teresa Cecena DBA Genesis UNDECYLENIC ACID; ZINC UNDECYLENATE 5; 18 g/100g; g/100g E 20171231 69772-130_4c0b52af-ac62-54d7-e054-00144ff88e88 69772-130 HUMAN OTC DRUG CREST ANTI-CAVITY SODIUM FLUORIDE PASTE, DENTIFRICE DENTAL 20170331 OTC MONOGRAPH FINAL part355 GENESIS IMPORTS & EXPORTS LLC SODIUM FLUORIDE 1.45 g/100mL N 20181231 69772-139_4d785380-befc-6f54-e054-00144ff8d46c 69772-139 HUMAN OTC DRUG HEAD AND SHOULDERS Pyrithione zinc LOTION/SHAMPOO TOPICAL 20150423 OTC MONOGRAPH FINAL part358H Teresa Cecena DBA Genesis PYRITHIONE ZINC .01 g/mL N 20181231 69772-141_15e90836-ae24-3979-e054-00144ff88e88 69772-141 HUMAN OTC DRUG HEAD AND SHOULDERS BREAKEGE PREVENTION PYRITHIONE ZINC 1% LOTION/SHAMPOO TOPICAL 20150512 OTC MONOGRAPH FINAL part358H TERESA CECENA DBA GENESIS PYRITHIONE ZINC .01 g/mL E 20171231 69772-200_616b57f0-5634-7772-e053-2a91aa0affd1 69772-200 HUMAN OTC DRUG CANESTEN V CLOTRIMAZOL CREAM VAGINAL 20160517 NDA NDA021143 GENESIS IMPORTS & EXPORTS LLC CLOTRIMAZOLE 2 g/100g N 20181231 69772-324_4d8aeaba-ddb8-6f74-e054-00144ff88e88 69772-324 HUMAN OTC DRUG Head And Shoulders 2 in 1 Smooth and silky Pyrithionr Zinc LOTION/SHAMPOO TOPICAL 20150513 OTC MONOGRAPH FINAL part358H Teresa Cecena DBA Genesis PYRITHIONE ZINC 1 g/mL N 20181231 69772-390_616b0caa-c2b8-0024-e053-2991aa0a51a9 69772-390 HUMAN OTC DRUG Vicks Vaporub camphor, eucalyptus oil, and menthol oilment OINTMENT TOPICAL 20161124 OTC MONOGRAPH FINAL part341 Genesis Imports & Exports EUCALYPTUS OIL; CAMPHOR (SYNTHETIC); MENTHOL .012; .048; .026 g/g; g/g; g/g N 20181231 69772-440_1cbb8491-6ef8-45af-e054-00144ff88e88 69772-440 HUMAN OTC DRUG XL3 XTRA acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled CAPSULE, LIQUID FILLED ORAL 20150807 OTC MONOGRAPH FINAL part341 Teresa Cecena DBA Genesis DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 10; 5; 250; 2 mg/mg; mg/mg; mg/mg; mg/mg E 20171231 69772-500_1703aab5-f83b-0d3b-e054-00144ff8d46c 69772-500 HUMAN OTC DRUG Manzanilla Sophia Matricaria recutita LIQUID OPHTHALMIC 20150527 UNAPPROVED HOMEOPATHIC Teresa Cecena DBA Genesis MATRICARIA RECUTITA 3 [hp_X]/mL E 20171231 69772-615_1702805f-9a79-3204-e054-00144ff8d46c 69772-615 HUMAN OTC DRUG Ponds Clarant B3 AVOBENZONE CREAM TOPICAL 20150526 OTC MONOGRAPH FINAL part352 Teresa Cecena DBA Genesis AVOBENZONE 100 g/3g E 20171231 69772-819_19214ba6-0d86-639a-e054-00144ff8d46c 69772-819 HUMAN OTC DRUG Crest Complete Deep Clean Sodium Fluoride PASTE, DENTIFRICE DENTAL 20150622 OTC MONOGRAPH FINAL part355 Teresa Cecena DBA Genesis SODIUM FLUORIDE 2.43 mg/100mL E 20171231 69772-820_2a6bf243-b168-484d-e054-00144ff8d46c 69772-820 HUMAN OTC DRUG Crest Expressions Scope sodium fluoride PASTE, DENTIFRICE ORAL 20160128 OTC MONOGRAPH FINAL part355 Teresa Cecena DBA Genesis Imports SODIUM FLUORIDE 243 mg/g E 20171231 69772-900_165dfeb4-8192-4e5a-e054-00144ff88e88 69772-900 HUMAN OTC DRUG Stefano Stick Aluminium Chlorohydrate STICK TOPICAL 20150518 OTC MONOGRAPH FINAL part350 Teresa Cecena DBA Genesis ALUMINUM CHLOROHYDRATE 25 g/100mL E 20171231 69772-980_1663d00b-77e2-56fc-e054-00144ff8d46c 69772-980 HUMAN OTC DRUG Stefano Fire Aluminum Chlorohydrate LIQUID TOPICAL 20150518 OTC MONOGRAPH FINAL part350 Teresa Cecena DBA Genesis ALUMINUM CHLOROHYDRATE 25 g/100mL E 20171231 69773-010_d00a6191-c6a3-4947-b888-0a1b76fc345d 69773-010 HUMAN OTC DRUG Hair Green Mugungseang Dimethicone SHAMPOO TOPICAL 20150401 OTC MONOGRAPH FINAL part347 HAIRGREEN DIMETHICONE 4 mg/400mL E 20171231 69773-020_47087d07-bb32-4cb9-8887-a266a923b653 69773-020 HUMAN OTC DRUG Hair Green Mugungjin Tonic Salicylic Acid SOLUTION TOPICAL 20150801 OTC MONOGRAPH FINAL part358H HAIRGREEN SALICYLIC ACID 1 mg/200mL E 20171231 69774-008_14d4043a-a792-3fba-e054-00144ff88e88 69774-008 HUMAN OTC DRUG VMV HYPOALLERGENICS ARMADA SPORT 50 AVOBENZONE, HOMOSALATE, OCTISALATE CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part352 SKIN SCIENCES LABORATORY INC. AVOBENZONE; HOMOSALATE; OCTISALATE 3; 15; 5 g/85g; g/85g; g/85g E 20171231 69774-103_1fc52f3b-3a63-3fa5-e054-00144ff8d46c 69774-103 HUMAN OTC DRUG VMV HYPOALLERGENICS ARMADA BABY 50 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part352 SKIN SCIENCES LABORATORY INC. TITANIUM DIOXIDE; ZINC OXIDE 13.2; 15 g/50g; g/50g E 20171231 69774-163_1fc12db9-6564-509b-e054-00144ff88e88 69774-163 HUMAN OTC DRUG VMV HYPOALLERGENICS ARMADA POST PROCEDURE 50 PLUS TITANIUM DIOXIDE, ZINC OXIDE, CREAM TOPICAL 20150101 OTC MONOGRAPH FINAL part352 SKIN SCIENCES LABORATORY INC. TITANIUM DIOXIDE; ZINC OXIDE 13.2; 15 g/30g; g/30g E 20171231 69774-536_14ebd3fc-e74c-226f-e054-00144ff8d46c 69774-536 HUMAN OTC DRUG VMV HYPOALLERGENICS ARMADA 30 ENSULIZOLE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 SKIN SCIENCES LABORATORY INC. TITANIUM DIOXIDE; OCTISALATE; ENSULIZOLE; ZINC OXIDE .6; 3; 4; 23 g/85g; g/85g; g/85g; g/85g E 20171231 69774-551_4a1faf2b-bf8d-3249-e054-00144ff8d46c 69774-551 HUMAN OTC DRUG VMV HYPOALLERGENICS ID SKIN-BUFFING CLEANSING SCRUB SALICYLIC ACID EMULSION TOPICAL 20170515 OTC MONOGRAPH FINAL part333D SKIN SCIENCES LABORATORY INC. SALICYLIC ACID 1.2 g/120mL N 20181231 69774-552_4ddf653c-2dfd-28bd-e054-00144ff8d46c 69774-552 HUMAN OTC DRUG ID Anti-Acne Toner Clarifying Face Plus Body Treatment Salicylic Acid LIQUID TOPICAL 20170415 OTC MONOGRAPH FINAL part333D SKIN SCIENCES LABORATORY INC. SALICYLIC ACID 1.2 g/120mL N 20181231 69774-553_4ddf653c-2e01-28bd-e054-00144ff8d46c 69774-553 HUMAN OTC DRUG ID ANTI ACNE Salicylic Acid LOTION TOPICAL 20170415 OTC MONOGRAPH FINAL part333D SKIN SCIENCES LABORATORY INC. SALICYLIC ACID 2.15 g/110mL N 20181231 69774-554_4df74fe3-c6d9-03d3-e054-00144ff8d46c 69774-554 HUMAN OTC DRUG ID CLARIFYING BODY Salicylic Acid SOAP TOPICAL 20170415 OTC MONOGRAPH FINAL part333D SKIN SCIENCES LABORATORY INC. SALICYLIC ACID 1.35 g/135g N 20181231 69774-751_4aa71dc9-39fe-63a2-e054-00144ff88e88 69774-751 HUMAN OTC DRUG ESSENCE SKIN-SAVING ANTIPERSPIRANT ALUMINUM CHLOROHYDRATE SPRAY TOPICAL 20170401 OTC MONOGRAPH FINAL part350 SKIN SCIENCES LABORATORY INC. ALUMINUM CHLOROHYDRATE 30 g/150mL N 20181231 69774-944_50b46e65-4188-557a-e054-00144ff88e88 69774-944 HUMAN OTC DRUG RED BETTER SPOT CORRECTOR non-drying acne balm Salicylic Acid, Sulfur CREAM TOPICAL 20170530 OTC MONOGRAPH FINAL part333D SKIN SCIENCES LABORATORY INC. SULFUR; SALICYLIC ACID .08; .16 g/8g; g/8g N 20181231 69777-010_f8861297-55ca-4647-843c-14e4eb8eccb6 69777-010 HUMAN OTC DRUG MAY NEWYORK SUPER SUN Octinoxate, Zinc Oxide, Titanium Dioxide STICK TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part352 NATURE & NATURE CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 1.4; .98; .83 g/20g; g/20g; g/20g N 20181231 69777-020_58be964c-df6e-4044-a0d2-53827f83981b 69777-020 HUMAN OTC DRUG MAY NEWYORK SUPER SUN 10G Octinoxate, Zinc oxide, Titanium dioxide STICK TOPICAL 20150301 OTC MONOGRAPH NOT FINAL part352 NATURE & NATURE CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE .7; .49; .41 g/10g; g/10g; g/10g N 20181231 69777-030_fdf70b37-9215-4f9b-90ed-5f6f57344165 69777-030 HUMAN OTC DRUG May New York Super Clear Sun 21g Octinoxate, Homosalate, Octisalate, Octocrylene STICK TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 NATURE & NATURE CO., LTD. OCTINOXATE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.47; 1.05; .94; .42 g/21g; g/21g; g/21g; g/21g N 20181231 69777-040_f8d310ce-1ad7-4a31-b1cb-a9c1227bd083 69777-040 HUMAN OTC DRUG May New York Super Clear Sun 16g Octinoxate, Homosalate, Octisalate, Octocrylene STICK TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 NATURE & NATURE CO., LTD. OCTINOXATE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 1.12; .8; .72; .32 g/16g; g/16g; g/16g; g/16g N 20181231 69777-070_caa9a1da-2ec6-4a47-9c32-2c3d71411381 69777-070 HUMAN OTC DRUG DoctorsLab Returning Platinum Mask Niacinamide, Adenosine PATCH TOPICAL 20161201 UNAPPROVED DRUG OTHER NATURE & NATURE CO., LTD NIACINAMIDE; ADENOSINE .6; .01 g/30mL; g/30mL N 20181231 69777-080_a0d110fc-0dfb-4efd-a745-3ba9e986de4a 69777-080 HUMAN OTC DRUG DoctorsLab Derma Cover Tattoo Foundation No.21 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170302 OTC MONOGRAPH NOT FINAL part352 NATURE & NATURE CO., LTD TITANIUM DIOXIDE; ZINC OXIDE 3.47; .21 g/15mL; g/15mL N 20181231 69777-090_1550da0d-d4c7-4e59-b6b4-5d4597f4270b 69777-090 HUMAN OTC DRUG DoctorsLab Derma Cover Tattoo Foundation No.23 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170302 OTC MONOGRAPH NOT FINAL part352 NATURE & NATURE CO., LTD TITANIUM DIOXIDE; ZINC OXIDE 3.47; .21 g/15mL; g/15mL N 20181231 69777-100_969a19da-6601-407d-85ac-cb755e992087 69777-100 HUMAN OTC DRUG MAY NEW YORK SUPER CLEAR PURE SUN 22g Octinoxate, Octisalate, Octocrylene STICK TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 NATURE & NATURE CO., LTD OCTINOXATE; OCTISALATE; OCTOCRYLENE 1.54; .99; .44 g/22g; g/22g; g/22g N 20181231 69777-110_8b5d5ea2-f88f-45bb-872b-5fc995506a7d 69777-110 HUMAN OTC DRUG MAY NEW YORK SUPER CLEAR PURE SUN 17g Octinoxate, Octisalate, Octocrylene STICK TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 NATURE & NATURE CO., LTD OCTINOXATE; OCTISALATE; OCTOCRYLENE 1.19; .76; .34 g/17g; g/17g; g/17g N 20181231 69777-120_614d9c34-37ff-47f7-9112-580c87ceb108 69777-120 HUMAN OTC DRUG DoctorsLab Derma Skin Aura Pearl Base Titanium Dioxide CREAM TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 NATURE & NATURE CO., LTD TITANIUM DIOXIDE 1.38 g/50mL N 20181231 69777-130_c5ec2535-559a-45e9-aac8-1e2548181249 69777-130 HUMAN OTC DRUG DoctorsLab Returning Platinum Neck Niacinamide, Adenosine PATCH TOPICAL 20170501 UNAPPROVED DRUG OTHER NATURE & NATURE CO., LTD NIACINAMIDE; ADENOSINE .3; .006 g/15mL; g/15mL N 20181231 69777-160_82d4dbfc-7a69-4fdf-9de8-c4c763e41730 69777-160 HUMAN OTC DRUG ORGAPLUS ULTRA PURE SUN 22g Octinoxate, Octisalate, Octocrylene STICK TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE & NATURE CO., LTD OCTINOXATE; OCTISALATE; OCTOCRYLENE 1.54; .99; .44 g/22g; g/22g; g/22g N 20181231 69777-170_dfc199e6-fce0-415f-880a-142980d5722d 69777-170 HUMAN OTC DRUG ORGAPLUS ULTRA PURE SUN 15g Octinoxate, Octisalate, Octocrylene STICK TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 NATURE & NATURE CO., LTD OCTINOXATE; OCTISALATE; OCTOCRYLENE 1.05; .67; .3 g/15g; g/15g; g/15g N 20181231 69777-180_91d76267-19a1-41fd-b1bb-c212c33fa582 69777-180 HUMAN OTC DRUG OrgaPlus Super Care Balm for combination and oi ly skin type 14g SUNFLOWER STICK TOPICAL 20171101 UNAPPROVED DRUG OTHER NATURE & NATURE CO.,LTD. SUNFLOWER OIL 7.92 g/14g N 20181231 69777-190_22054f73-b662-410f-b79d-ad6837379a76 69777-190 HUMAN OTC DRUG OrgaPlus Super Care Balm for combination and oi ly skin type 20g SUNFLOWER STICK TOPICAL 20171101 UNAPPROVED DRUG OTHER NATURE & NATURE CO.,LTD. SUNFLOWER OIL 11.31 g/20g N 20181231 69778-930_5f2379e6-9041-4de6-83a2-f63fa36db0d9 69778-930 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101015 ANDA ANDA065152 Pharma-C, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 69778-931_5f2379e6-9041-4de6-83a2-f63fa36db0d9 69778-931 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20101015 ANDA ANDA065152 Pharma-C, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 69779-001_36df6c78-28ac-4319-8ab8-411982c786bf 69779-001 HUMAN OTC DRUG blood sugar Calc Phos, Carpinus betulus, flos, Ferrum Phos, Kali Phos, Nat Mur, Nat Sulph, Olea europaea, flos, Silicea, Sinapis arvensis, flos SPRAY ORAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences, LLC TRIBASIC CALCIUM PHOSPHATE; CARPINUS BETULUS FLOWER; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM SULFATE; OLEA EUROPAEA FLOWER; SILICON DIOXIDE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP 12; 12; 12; 6; 6; 6; 5; 12; 5 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-002_cdf17efd-0f5c-4add-9170-b03427397a3b 69779-002 HUMAN OTC DRUG digest Aesculus hippocastanum, bud, Cal Phos, Carpinus betulus, flos, Kali Phos, Mag Phos, Nat Mur, Nat Sulph, Ulmus procera, flos SPRAY ORAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC HORSE CHESTNUT; TRIBASIC CALCIUM PHOSPHATE; CARPINUS BETULUS FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; ULMUS PROCERA FLOWERING TWIG 5; 12; 5; 6; 12; 6; 5 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-003_8eb11304-bd89-4c1d-8c48-274cbd9051c5 69779-003 HUMAN OTC DRUG emotional detox Calc Phos, Calc Sulph, Castanea sativa, flos, Ilex aquifolium, flos, Kali Phos, Nat Mur, Nat Phos, Nat Sulph, Olea europaea, flos, Ornithogalum umbellatum, flos SPRAY ORAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; CASTANEA SATIVA FLOWER; ILEX AQUIFOLIUM FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP 12; 6; 5; 5; 6; 6; 6; 6; 5; 5 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-004_0730fa39-d1f2-45ae-b517-f2f6ee10d9d1 69779-004 HUMAN OTC DRUG female balance Calc Phos, Cichorium intybus, flos, Ferrum Phos, Juglans regia, flos, Kali Phos, Lachesis, Mag Phos, Sepia, Sinapis arvensis, flos SPRAY ORAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC TRIBASIC CALCIUM PHOSPHATE; CICHORIUM INTYBUS FLOWER; FERROSOFERRIC PHOSPHATE; JUGLANS REGIA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; SINAPIS ARVENSIS FLOWERING/FRUITING TOP 12; 5; 12; 5; 6; 6; 12; 6; 5 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL N 20181231 69779-005_64dd41a3-a7f6-45bf-8122-6520114b9554 69779-005 HUMAN OTC DRUG healthy hair Certostigma willmottianum, flos, Kali Sulph, Larix decidua, flos, Mimulus guttatus, flos, Nat Mur, Nat Phos, Silicea SPRAY TOPICAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC CERATOSTIGMA WILLMOTTIANUM FLOWER; POTASSIUM SULFATE; LARIX DECIDUA FLOWERING TOP; MIMULUS GUTTATUS FLOWERING TOP; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE 5; 6; 5; 5; 6; 6; 12 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-006_a4aff06c-8eda-4e81-8b93-db566f5c2885 69779-006 HUMAN OTC DRUG hearing Aesculus hippocastanum, flos, Calc Sulp, Calluna vulgaris, flos, Clematis vitalba, flos, Fer Phos, Kali Mur, Kali Sulph SPRAY ORAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC AESCULUS HIPPOCASTANUM FLOWER; CALCIUM SULFATE ANHYDROUS; CALLUNA VULGARIS FLOWERING TOP; CLEMATIS VITALBA FLOWER; FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM SULFATE 5; 6; 5; 5; 12; 6; 6 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-007_3f387b75-419b-43c8-8560-aeb4a40906f2 69779-007 HUMAN OTC DRUG lung and sinus Calc Phos, Ferrum Phos, Gentianella amarella, flos, Kali Mur, Kali Phos, Kali Sulph, Rock water, Rose canina, flos SPRAY ORAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; GENTIANELLA AMARELLA FLOWER; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; WATER; ROSA CANINA FLOWER 12; 12; 5; 6; 6; 6; 5; 5 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-008_34025a93-c885-443c-aac5-552a633c3df9 69779-008 HUMAN OTC DRUG male balance Centarium umbellatum, flos, Ceratostigma willmottianum, flos, Kali Phos, Larix decidua, flos, Lycopodium, Nat Mur, Nat Phos, Silicea SPRAY ORAL 20150506 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC CENTAURIUM ERYTHRAEA FLOWER; CERATOSTIGMA WILLMOTTIANUM FLOWER; POTASSIUM PHOSPHATE, DIBASIC; LARIX DECIDUA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SILICON DIOXIDE 5; 5; 6; 5; 6; 6; 6; 12 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-009_2bb796e1-8f66-4cd2-9f6c-a5f8031e3d90 69779-009 HUMAN OTC DRUG muscles and joints Calc Fluor, Calc Phos, Carpinus betulus, flos, Ilex aquifolium, flos, Kali Sulph, Mag Phos, Nat Phos, Quercus robur, flos, Silicea SPRAY ORAL; TOPICAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CARPINUS BETULUS FLOWERING TOP; ILEX AQUIFOLIUM FLOWERING TOP; POTASSIUM SULFATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; QUERCUS ROBUR FLOWER; SILICON DIOXIDE 12; 12; 5; 5; 6; 12; 6; 6; 5; 12 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-010_93c916f4-0d57-4689-a94d-136d4d9d4569 69779-010 HUMAN OTC DRUG sight Aesculus hippocastanum, bud, Bromus ramosus, flos, Calc Fluorica, Calc Phos, Calc Sulph, Clematis vitalba, flos, Ferrum Phos, Mag Phos, Nat Mur, Silicea SPRAY ORAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC HORSE CHESTNUT; BROMUS RAMOSUS FLOWER; CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; CLEMATIS VITALBA FLOWER; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SILICON DIOXIDE 5; 5; 12; 12; 6; 5; 12; 12; 6; 12 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-011_6825b762-8558-48a7-8717-a644d5027d5b 69779-011 HUMAN OTC DRUG throat and voice Ceratostigma willmottianum, flos, Ferrum Phos, Hottonia palustris, flos, Kali Mur, Kali Phos, Mag Phos, Mimulus guttatus, flos, Nat Mur, Nat Sulph, Silicea SPRAY ORAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC CERATOSTIGMA WILLMOTTIANUM FLOWER; FERROSOFERRIC PHOSPHATE; HOTTONIA PALUSTRIS FLOWER; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MIMULUS GUTTATUS FLOWERING TOP; SODIUM CHLORIDE; SODIUM SULFATE; SILICON DIOXIDE 5; 12; 5; 6; 6; 12; 5; 6; 6; 12 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-012_afe0e6c8-fcc4-4c4c-9a01-7bac5dd04a2f 69779-012 HUMAN OTC DRUG sleep Aesculus hippocastanum, flos, Ferrum Phos, Kali Carb, Kali Phos, Mag Phos, Nat Mur, Populus termula, flos, Prunus cerasifera, flos SPRAY ORAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC AESCULUS HIPPOCASTANUM FLOWER; FERROSOFERRIC PHOSPHATE; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; POPULUS TREMULA FLOWERING TOP; PRUNUS CERASIFERA FLOWER 5; 12; 6; 6; 12; 6; 5; 5 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-013_912b930c-ce71-42b5-b081-5e37d79ff0a0 69779-013 HUMAN OTC DRUG stress relief Aesculus hippocastanum, flos, Calc Phos, Fagus sylvatica, flos, Impatiens glandulifera, flos, Kali Phos, Mag Phos, Prunus cerasifera, flos SPRAY ORAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC AESCULUS HIPPOCASTANUM FLOWER; TRIBASIC CALCIUM PHOSPHATE; FAGUS SYLVATICA FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PRUNUS CERASIFERA FLOWER 5; 12; 5; 5; 6; 12; 5 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-014_0593efec-2149-495a-98c3-2d5f7afb2de9 69779-014 HUMAN OTC DRUG teeth and gums Calc Fluorica, Calc Phos, Ferrum Phos, Kali Phos, Mag Phos, Malus pumila, flos, Rock water, Ulex europaeus, flos SPRAY ORAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MALUS DOMESTICA FLOWER; WATER; ULEX EUROPAEUS FLOWER 12; 12; 12; 6; 12; 5; 5; 5 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-015_9d5b38be-cdf4-491b-a3b7-df153bf78317 69779-015 HUMAN OTC DRUG youthful skin Aesculus hippocastanum, bud, Agrimonia eupatoria, flos, Calc Fluorica, Calc Sulph, Ferrum Phos, Kali Sulph, Malus pumila, flos, Nat Mur, Silicea SPRAY TOPICAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC HORSE CHESTNUT; AGRIMONIA EUPATORIA FLOWER; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERROSOFERRIC PHOSPHATE; POTASSIUM SULFATE; MALUS DOMESTICA FLOWER; SODIUM CHLORIDE; SILICON DIOXIDE 5; 5; 12; 6; 12; 6; 5; 6; 12 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-016_4c788e7b-169e-428f-93ed-53f72153b59a 69779-016 HUMAN OTC DRUG happy heart Bromus ramosus, flos, Calc Fluor, Centaurium umbellatum, flos, Fer Phos, Ilex aquifolium, flos, Kali Phos, Mag Phos, Nat Mur SPRAY ORAL 20150506 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC BROMUS RAMOSUS FLOWER; CALCIUM FLUORIDE; CENTAURIUM ERYTHRAEA FLOWER; FERROSOFERRIC PHOSPHATE; ILEX AQUIFOLIUM FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE 5; 12; 5; 12; 5; 6; 12; 6 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-017_79be1016-3f8e-4733-bb8f-3323287d02bd 69779-017 HUMAN OTC DRUG attention and focus Aesculus hippocastanum, bud, Baryta Carb, Calc Carb, Calc Phos, Clematis vitalba, flos, Gentianella amarella, flos, Impatiens glandulifera, flos, Kali Phos, Mag Phos SPRAY ORAL; TOPICAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC HORSE CHESTNUT; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; CLEMATIS VITALBA FLOWER; GENTIANELLA AMARELLA FLOWER; IMPATIENS GLANDULIFERA FLOWER; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 5; 9; 6; 12; 5; 5; 5; 6; 12 [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-018_39a1310c-9819-44dc-8a4b-c9e4306ea8ff 69779-018 HUMAN OTC DRUG soothe and sleep Aesculus hippocastanum, flos, Chamomilla, Ferr Phos, Helianthemum nummularium, flos, mimulus guttatus, flos, Nat Mur, Nat Phos, Nat Sulph, Phosphorus, Verbena officinalis, flos SPRAY ORAL; TOPICAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC AESCULUS HIPPOCASTANUM FLOWER; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; HELIANTHEMUM NUMMULARIUM FLOWER; MIMULUS GUTTATUS FLOWERING TOP; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; PHOSPHORUS; VERBENA OFFICINALIS FLOWERING TOP 5; 6; 12; 5; 5; 6; 6; 6; 6; 5 [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL N 20181231 69779-019_37963afe-6513-4886-a04b-b2c5ba844b54 69779-019 HUMAN OTC DRUG stress relief Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Calc Phos, Chamomilla, Helianthemum nummularium, flos, Kali Phos, Mag Phos, Nat Mur, Populus tremuloides, flos SPRAY ORAL; TOPICAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC AESCULUS HIPPOCASTANUM FLOWER; AGRIMONIA EUPATORIA FLOWER; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; HELIANTHEMUM NUMMULARIUM FLOWER; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; POPULUS TREMULA FLOWERING TOP 5; 5; 12; 6; 5; 6; 12; 6; 5 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20181231 69779-020_c9f57504-8fe0-4894-b037-1b88d49cd795 69779-020 HUMAN OTC DRUG temper tamer Fagus sylvatica, flos, Ilex aquifolium, flos, Impatiens glandulifera, flos, Kali Phos, Lycopodium, Nat Mur, Nux Vomica, Prunus cerasifera, flos, Silicea, Tarent SPRAY ORAL; TOPICAL 20150409 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC FAGUS SYLVATICA FLOWERING TOP; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PRUNUS CERASIFERA FLOWER; SILICON DIOXIDE; LYCOSA TARANTULA 5; 5; 5; 6; 6; 6; 6; 5; 12; 9 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL N 20181231 69779-025_c6e8f338-2d69-45f5-910a-993039dc8c1b 69779-025 HUMAN OTC DRUG mind and memory Aesculus hippocastanum flos, Calc Phos, Calc Sulph, Clematis vitalba flos, Kali Phos, Mag Phos, Nat Mur, Scleranthus annuus flow, Silicea SPRAY ORAL 20180116 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC HORSE CHESTNUT; TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; CLEMATIS VITALBA FLOWER; DIBASIC POTASSIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SCLERANTHUS ANNUUS FLOWERING TOP; SILICON DIOXIDE 5; 12; 6; 5; 6; 12; 6; 5; 12 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20191231 69779-026_8b9b4472-a56f-4123-b711-b6e15563a113 69779-026 HUMAN OTC DRUG grief and loss Calc Phos, Calc Sulph, Castanea sativa flos, Ignatia Amara, Juglans regia flos, Kali Phos, Nat Mur, Nat Sulph, Ornitholagum umbellatum flos, Phos Acid SPRAY ORAL 20180116 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; CASTANEA SATIVA FLOWER; STRYCHNOS IGNATII SEED; JUGLANS REGIA FLOWERING TOP; DIBASIC POTASSIUM PHOSPHATE; SODIUM CHLORIDE; SODIUM SULFATE; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PHOSPHORIC ACID 12; 6; 5; 6; 5; 6; 6; 6; 5; 6 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL N 20191231 69779-027_061e6294-3dc7-4df6-bc81-df4fca3977a1 69779-027 HUMAN OTC DRUG mood and patience Calc Phos, Calc Sulph, Carpinus betulus flos, Fer Phos, Ilex aquifolium flos, Impatiens glandulifera flos, Kali Phos, Mag Phos, Nat Mur, Nat Sulph SPRAY ORAL 20180116 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC TRIBASIC CALCIUM PHOSPHATE; CALCIUM SULFATE ANHYDROUS; CARPINUS BETULUS FLOWERING TOP; FERROSOFERRIC PHOSPHATE; ILEX AQUIFOLIUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; DIBASIC POTASSIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM SULFATE 12; 6; 5; 12; 5; 5; 6; 12; 6; 6 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL N 20191231 69779-028_8c0cbe30-9fd8-4b4a-aedc-dd5f4288594c 69779-028 HUMAN OTC DRUG energy and motivation Calc Sulph, Gentiana amarella flos, Kali Phos, Nat Mur, Nat Phos, Nat Sulph, Olea europea flos, Phos Acid, Ulex europaeus flos SPRAY ORAL 20180116 UNAPPROVED HOMEOPATHIC Siddha Flower Essences LLC CALCIUM SULFATE ANHYDROUS; GENTIANELLA AMARELLA FLOWER; DIBASIC POTASSIUM PHOSPHATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; OLEA EUROPAEA FLOWER; PHOSPHORIC ACID; ULEX EUROPAEUS FLOWER 6; 5; 6; 6; 6; 6; 5; 6; 5 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_C]/29.6mL; [hp_X]/29.6mL N 20191231 69780-0001_34eaa270-2819-4436-8138-0ea55e83c521 69780-0001 HUMAN OTC DRUG Fat Loss Activation Complex Fucus vesiculosus, Kali Carbonicum, Phytolacca decandra, Agave americana, Capsicum annuum, Aurum metallicum, Calcarea carbonica, Ferrum metallicum, Graphites, LIQUID ORAL 20150701 UNAPPROVED HOMEOPATHIC True Weight Loss Solutions FUCUS VESICULOSUS; POTASSIUM CARBONATE; PHYTOLACCA AMERICANA ROOT; AGAVE AMERICANA LEAF; CAPSICUM; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IRON; GRAPHITE 2; 2; 2; 3; 4; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69780-0002_f48a33bb-2d84-4471-a9d8-7b2deaf46287 69780-0002 HUMAN OTC DRUG Detox Complex Carduus Marianus, Cynara Scolymus, Solidago Virgaurea, Taraxacum Officinale, Benzoicum Acidum, Berberis Vulgaris, Bryonia (Alba), Cantharis, Carduus Benedictus, Ceanothus Americanus, Dioscorea Villosa, Dolichos Pruriens, Iris Versicolor, Juniperus Communis, Nux Vomica, Ptelea Trifoliata, Uricum Acidum LIQUID ORAL 20160229 UNAPPROVED HOMEOPATHIC True Weight Loss Solutions MILK THISTLE; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; URIC ACID 3; 3; 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69780-0003_f132ae26-9691-4fbb-839b-8cd1339f8c76 69780-0003 HUMAN OTC DRUG Energy Complex Echinacea (Angustifolia), Lappa Major, Solidago Virgaurea, Taraxacum Officinale, Adrenalinum, Aloe, Arsenicum Album, Baptisia Tinctoria, Berberis Aquifolium, Berberis Vulgaris, Bryonia (Alba), Chelidonium Majus, Crotalus Horridus, Digitalis Purpurea, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Iodium, Iris Versicolor, Lachesis Mutus, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Ruta Graveolens, Thuja Occidentalis, Thyroidinum (Bovine) LIQUID ORAL 20160229 UNAPPROVED HOMEOPATHIC True Weight Loss Solutions ECHINACEA ANGUSTIFOLIA; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; EPINEPHRINE; ALOE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, BOVINE 3; 3; 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69780-0004_7e2e1f8e-117a-42ac-b9aa-c24c55dc5905 69780-0004 HUMAN OTC DRUG Appetite Control Chamomilla, Passiflora Incarnata, Valeriana Officinalis, Chamomilla, Passiflora Incarnata, Valeriana Officinalis, Anacardium Orientale, Antimonium Crudum, Argentum Nitricum, Berberis Vulgaris, Bryonia (Alba), Chelidonium Majus, Digitalis Purpurea, Graphites, Humulus Lupulus, Iris Versicolor, Kali Carbonicum, Lycopodium Clavatum, Natrum Carbonicum, Natrum Sulphuricum, Nux Vomica, Pulsatilla (Pratensis), Rhus Tox, Scutellaria Lateriflora, Sepia, Stramonium LIQUID ORAL 20160229 UNAPPROVED HOMEOPATHIC True Weight Loss Solutions MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; ANEMONE PRATENSIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM 3; 3; 3; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69780-0005_bc951f9b-acc7-4fe5-9247-397c648c8bf1 69780-0005 HUMAN OTC DRUG Fat Loss Activation Complex Fucus Vesiculosus, Kali Carbonicum, Phytolacca Decandra, Agave Americana, Capsicum Annuum, Aurum Metallicum, Calcarea Carbonica, Ferrum Metallicum, Graphites LIQUID ORAL 20170728 UNAPPROVED HOMEOPATHIC True Weight Loss Solutions FUCUS VESICULOSUS; POTASSIUM CARBONATE; PHYTOLACCA AMERICANA ROOT; AGAVE AMERICANA LEAF; CAPSICUM; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IRON; GRAPHITE 2; 2; 2; 4; 4; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69780-0011_17a286f7-c580-52dd-e054-00144ff8d46c 69780-0011 HUMAN PRESCRIPTION DRUG Detox Complex BENZOICUM ACIDUM, BERBERIS VULG., BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DIOSCOREA, DOLICHOS, IRIS VERSICOLOR, JUNIPERUS COM., NUX VOM., PTELEA, TARAXACUM, URICUM ACIDUM, CARDUUS MAR., CYNARA SCOLYMUS, SOLIDAGO LIQUID ORAL 20150615 UNAPPROVED HOMEOPATHIC True Weight Loss Solutions BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; TARAXACUM OFFICINALE; URIC ACID; SILYBUM MARIANUM SEED; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 69780-0012_1aef3339-f551-3c25-e054-00144ff8d46c 69780-0012 HUMAN PRESCRIPTION DRUG Energy Complex Adrenalinum, Aloe socotrina, Arsenicum album, Baptisia tinctoris, Berberis acquifolium, Berberis vulgaris, Bryonia, Chelidonium majus, Crotalus horridus, Digitalis purpurea, Ferrum metallicum, Glonoinum, Glycyrrhiza glabra, Hydrocotyle asiatica, Iodium, Iris versicolor, Lachesis mutus, Lycoodium clavatum, Natrum muriaticum, Nux vomica, Rhus toxicodendron, Ruta graveolens, Thuja occidentalis, Thyroidinum, Echinacea, Lappa major, Solidago virgaurea, Taraxacum officinale LIQUID ORAL 20150615 UNAPPROVED HOMEOPATHIC True Weight Loss Solutions EPINEPHRINE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; ALOE; TARAXACUM OFFICINALE; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 15; 15; 15; 15; 3; 3; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient] N 20181231 69780-0013_1b021cdc-d5db-15d5-e054-00144ff8d46c 69780-0013 HUMAN PRESCRIPTION DRUG Appetite Control Anacardium orientale, Antimon. crud., Arg. nit., Berber. vulg., Bryonia, Chelidonium majus, Digitalis, Graphites, Humulus, Iris versicolor, Kali carb., Lycopodium, Nat. carb. , Nat. sulphuricum, Nux vom., Pulsatilla, Rhus toxicodendron, Scutellaria lateriflora, Sepia, Stramonium, Chamomilla, Passiflora, Valeriana LIQUID ORAL 20150615 UNAPPROVED HOMEOPATHIC True Weight Loss Solutions LYCOPODIUM CLAVATUM SPORE; SODIUM CARBONATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCUTELLARIA LATERIFLORA; SEPIA OFFICINALIS JUICE; DATURA STRAMONIUM; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER NITRATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; DIGITALIS; GRAPHITE; HOPS; IRIS VERSICOLOR ROOT; POTASSIUM CARBONATE 20; 20; 20; 20; 20; 20; 20; 20; 20; 8; 8; 8; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 69783-010_148efa2b-c09c-4c13-a98c-9be96ee9d602 69783-010 HUMAN OTC DRUG StemCell TeN 10 Revolutionary skin theraphy CENTELLA ASIATICA CREAM TOPICAL 20150401 UNAPPROVED DRUG OTHER Dr.Gene Co.,Ltd CENTELLA ASIATICA .3 mg/31 E 20171231 69783-020_5dd9a71c-b26f-4141-9aaa-9dbf92132921 69783-020 HUMAN OTC DRUG Dr Cellinme Mask Sheet Niacinamide PATCH TOPICAL 20150601 UNAPPROVED DRUG OTHER Dr.Gene Co.,Ltd NIACINAMIDE .6 mg/51 E 20171231 69783-030_d7021eb3-7c92-4b3c-a559-873f55c536d5 69783-030 HUMAN OTC DRUG Dr Cellinme Skin Care Ampoule Niacinamide SOLUTION TOPICAL 20150601 UNAPPROVED DRUG OTHER Dr.Gene Co.,Ltd NIACINAMIDE .1 mg/201 E 20171231 69784-102_1a50505c-619f-4727-bf0b-670519c3d44e 69784-102 HUMAN OTC DRUG Triprolidine Hydrochloride TRIPROLIDINE HYDROCHLORIDE LIQUID ORAL 20161010 OTC MONOGRAPH FINAL part341 Woodward Pharma Services LLC TRIPROLIDINE HYDROCHLORIDE .625 mg/mL N 20181231 69784-200_a3c1b417-3ebe-4470-a03c-7d0f2459d173 69784-200 HUMAN PRESCRIPTION DRUG CROMOLYN SODIUM CROMOLYN SODIUM SOLUTION, CONCENTRATE ORAL 20171016 ANDA ANDA209264 Woodward Pharma Services LLC CROMOLYN SODIUM 100 mg/5mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 69784-205_4fa6c5e0-7445-4cb3-be76-0d3e6285e334 69784-205 HUMAN PRESCRIPTION DRUG Cromolyn Sodium Cromolyn Sodium SOLUTION INTRABRONCHIAL 20171016 ANDA ANDA209453 Woodward Pharma Services LLC CROMOLYN SODIUM 20 mg/2mL Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC] N 20181231 69784-905_60b2e28d-8356-60dd-e053-2a91aa0a3c5a 69784-905 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET, EXTENDED RELEASE ORAL 20170526 ANDA ANDA040249 Woodward Pharma Services LLC ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 69785-010_5cfa51c6-4bbe-4fcf-b801-eed412a20d63 69785-010 HUMAN OTC DRUG Bien Vita Multi UV Primer Plus Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part352 CODEL INTERNATIONAL TITANIUM DIOXIDE; ZINC OXIDE 4.29; 1.7 mg/50mL; mg/50mL N 20181231 69788-000_2fbf3727-b36d-5236-e054-00144ff88e88 69788-000 HUMAN OTC DRUG Natural Sunscreen Zinc Oxide CREAM TOPICAL 20150507 OTC MONOGRAPH FINAL part352 MooGoo USA LLC ZINC OXIDE 24.96 g/100g N 20181231 69788-001_2fbf4c64-dfe8-4af8-e054-00144ff88e88 69788-001 HUMAN OTC DRUG Eczema colloidal oatmeal CREAM TOPICAL 20160405 OTC MONOGRAPH FINAL part347 MooGoo USA LLC OATMEAL 2.5 g/100g N 20181231 69788-002_a48df2fc-074d-49dd-8cfc-5525fd5631df 69788-002 HUMAN OTC DRUG A Bit Hippy colloidal oatmeal CREAM TOPICAL 20150512 OTC MONOGRAPH FINAL part347 MooGoo USA LLC OATMEAL 2.5 g/100g N 20181231 69789-104_161047ff-4c21-20fc-e054-00144ff88e88 69789-104 HUMAN OTC DRUG ISOPROPYL ALCOHOL PREP PAD STERILE ISOPROPYL ALCOHOL SWAB TOPICAL 20150514 OTC MONOGRAPH NOT FINAL part333A LSL Industries Inc ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 69790-279_6aaf0f5e-c267-4818-bf45-d905f0b063d0 69790-279 HUMAN OTC DRUG Antibacterial Benzalkonium chloride 0.13% SOAP TOPICAL 20150119 OTC MONOGRAPH NOT FINAL part333A Uline BENZALKONIUM CHLORIDE 1.3 g/mL N 20181231 69790-466_af1f4417-3b0a-416d-9344-eb8580d2c946 69790-466 HUMAN OTC DRUG Hand Wash Benzalkonium chloride SOAP TOPICAL 20160217 OTC MONOGRAPH NOT FINAL part333A ULINE BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 69790-641_561cbd6c-24eb-4eba-ba37-3b46b578f85c 69790-641 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20150106 OTC MONOGRAPH NOT FINAL part333A ULINE BENZALKONIUM CHLORIDE .999 mg/mL N 20181231 69790-770_d6aef3b3-0226-4099-ad4b-aafe9722af77 69790-770 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160328 OTC MONOGRAPH NOT FINAL part333A Uline ALCOHOL 70 mL/100mL N 20181231 69792-000_e4177075-5f1b-4e26-aea8-9e4f6b76adf8 69792-000 HUMAN OTC DRUG VIRx-H naja naja TABLET ORAL 20150513 UNAPPROVED HOMEOPATHIC Medforce Solutions Inc. NAJA NAJA VENOM 10 [hp_X]/1 E 20171231 69792-001_fd45d40d-42c9-4bfb-88a3-7d80a718f118 69792-001 HUMAN OTC DRUG VIRx-RA naja naja TABLET ORAL 20150513 UNAPPROVED HOMEOPATHIC Medforce Solutions Inc. NAJA NAJA VENOM 10 [hp_X]/1 E 20171231 69794-001_cf02ad78-c2d9-4804-b353-07d7379baa82 69794-001 HUMAN PRESCRIPTION DRUG MEPSEVII vestronidase alfa INJECTION INTRAVENOUS 20171115 BLA BLA761047 Ultragenyx Pharmaceutical Inc. VESTRONIDASE ALFA 2 mg/mL N 20181231 69795-000_fc23452d-50d2-486f-a50d-ab39d35bc6ad 69795-000 HUMAN OTC DRUG Berry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Jinxiong Technology Co ., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 69795-001_0c743f12-9356-4b2c-ac3e-9aaf69ff2173 69795-001 HUMAN OTC DRUG Strawberry Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Jinxiong Technology Co ., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 69795-002_4c5348ed-195f-430a-9e52-0c770b4930c0 69795-002 HUMAN OTC DRUG Mixed Berries Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Jinxiong Technology Co ., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 69795-003_0753b5db-0e79-4fc6-8d4e-512e2691db39 69795-003 HUMAN OTC DRUG Fruit Punch Scented Hand Sanitizer Benzalkonium Chloride GEL TOPICAL 20140604 OTC MONOGRAPH NOT FINAL part333E Foshan Jinxiong Technology Co ., Ltd. BENZALKONIUM CHLORIDE 1 g/59g N 20181231 69795-004_33113d9f-d1b3-332e-e054-00144ff88e88 69795-004 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-005_33113d9f-d1ba-332e-e054-00144ff88e88 69795-005 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-006_331157f4-5644-3e8e-e054-00144ff88e88 69795-006 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-007_33113d9f-d1c6-332e-e054-00144ff88e88 69795-007 HUMAN OTC DRUG Blueberry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-008_33128e92-5eed-7480-e054-00144ff8d46c 69795-008 HUMAN OTC DRUG Bubblegum Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-009_3311e130-7353-5a42-e054-00144ff88e88 69795-009 HUMAN OTC DRUG Bubblegum Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-010_33128e92-5efc-7480-e054-00144ff8d46c 69795-010 HUMAN OTC DRUG Cherry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-011_331156e8-52ca-4af8-e054-00144ff8d46c 69795-011 HUMAN OTC DRUG Cherry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-012_33128e92-5f0a-7480-e054-00144ff8d46c 69795-012 HUMAN OTC DRUG Cherry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-013_331224cd-4469-4a82-e054-00144ff8d46c 69795-013 HUMAN OTC DRUG Bubblegum Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-014_331224cd-4474-4a82-e054-00144ff8d46c 69795-014 HUMAN OTC DRUG Grape Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-015_33133874-2c46-4f92-e054-00144ff88e88 69795-015 HUMAN OTC DRUG Lemon Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-016_33113d9f-d1c2-332e-e054-00144ff88e88 69795-016 HUMAN OTC DRUG Fruit Punch Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-017_33133874-2c4b-4f92-e054-00144ff88e88 69795-017 HUMAN OTC DRUG Strawberry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-018_331224cd-445c-4a82-e054-00144ff8d46c 69795-018 HUMAN OTC DRUG Watermelon Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20160516 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-019_51876934-0db3-03a4-e054-00144ff8d46c 69795-019 HUMAN OTC DRUG 3 Pack Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20170103 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-020_51782097-138b-739e-e054-00144ff8d46c 69795-020 HUMAN OTC DRUG Cotton Candy Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20170609 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-021_51898e43-6c5a-13a8-e054-00144ff88e88 69795-021 HUMAN OTC DRUG Cotton Candy Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20170609 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-023_518a32f4-6294-216f-e054-00144ff8d46c 69795-023 HUMAN OTC DRUG Patriotic Berry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20170609 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-024_518ba63e-ad23-51f3-e054-00144ff88e88 69795-024 HUMAN OTC DRUG Wall Climbing Cherry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20170609 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-025_518b5a48-1341-4a51-e054-00144ff88e88 69795-025 HUMAN OTC DRUG Raspberry Scented Hand Sanitizer benzalkonium chloride GEL TOPICAL 20170609 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co., Ltd BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69795-026_575c22c6-4abf-c4dd-e053-2991aa0a11ad 69795-026 HUMAN OTC DRUG My Little Pony Cotton Candy Scented Benzalkonium Chloride GEL TOPICAL 20170822 OTC MONOGRAPH NOT FINAL part333A Foshan Jinxiong Technology Co ., Ltd. BENZALKONIUM CHLORIDE .1 g/100g N 20181231 69797-100_5e33cfd3-5c9a-1a87-e053-2a91aa0ad7a3 69797-100 HUMAN OTC DRUG Liquid Sex Lidocaine SPRAY, METERED TOPICAL 20171117 OTC MONOGRAPH FINAL part348 WSM Investment LLC. Topco Sales LIDOCAINE 10 mg/100mL N 20181231 69797-101_60528224-b0ff-6b38-e053-2a91aa0a18d2 69797-101 HUMAN OTC DRUG Liquid Sex Lidocaine GEL TOPICAL 20171214 OTC MONOGRAPH FINAL part346 WSM Investment LLC. Topco Sales LIDOCAINE 2.36 g/118mL N 20181231 69797-103_606958bb-33e9-6a69-e053-2991aa0ab0e4 69797-103 HUMAN OTC DRUG Bottoms Up Lidocaine LIQUID TOPICAL 20171215 OTC MONOGRAPH FINAL part346 WSM Investment LLC dba Topco Sales LIDOCAINE 3.4 g/68mL N 20181231 69797-104_60b7577d-53aa-4f6f-e053-2991aa0a4480 69797-104 HUMAN OTC DRUG Prolong Plus Benzocaine CREAM TOPICAL 20171219 OTC MONOGRAPH FINAL part348 WSM Investment LL. Topco Sales BENZOCAINE 4.2 g/56g N 20181231 69798-001_563cf998-d5c1-4128-b32b-679db590e839 69798-001 HUMAN OTC DRUG ODEUR Senior Premium Cleanser Menthol GEL TOPICAL 20150511 UNAPPROVED DRUG OTHER SJ Bio Co., Ltd. MENTHOL .63 g/632.19g E 20171231 69798-002_27503171-06f9-42eb-9c97-0f1e872949b6 69798-002 HUMAN OTC DRUG Odeur Premium Body Cleanser Menthol GEL TOPICAL 20151215 UNAPPROVED DRUG OTHER SJ Bio Co., Ltd. MENTHOL, UNSPECIFIED FORM .33 mg/660mL E 20171231 69802-025_53f7aeff-0fb1-4b4a-8c18-06f0a77e12aa 69802-025 HUMAN OTC DRUG Skindurance Dimethicone STICK TOPICAL 20150501 OTC MONOGRAPH FINAL part347 Skindure, LLC DIMETHICONE 1 mg/100mg N 20181231 69803-100_3b390196-e066-2a2d-e054-00144ff88e88 69803-100 HUMAN PRESCRIPTION DRUG Kovanaze tetracaine hydrochloride and oxymetazoline hydrochloride SPRAY NASAL 20160901 NDA NDA208032 St. Renatus TETRACAINE HYDROCHLORIDE; OXYMETAZOLINE HYDROCHLORIDE 30; .5 mg/mL; mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE],Vasoconstrictor [EPC],Vasoconstriction [PE],Increased Sympathetic Activity [PE],Imidazolines [Chemical/Ingredient] N 20181231 69804-001_5da8fc5e-8514-2b66-e053-2991aa0aca92 69804-001 HUMAN OTC DRUG Extra Strength PreTAT lidocaine LIQUID TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-002_5da95864-47f2-2f34-e053-2991aa0a9c3f 69804-002 HUMAN OTC DRUG Extra Strength PreTAT Lidocaine HCL CREAM TOPICAL 20150608 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-003_1ec9a16b-d695-1d4e-e054-00144ff88e88 69804-003 HUMAN OTC DRUG Extra Strength AfterTAT lidocaine HCL CREAM TOPICAL 20150907 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 20 mg/1000mg N 20181231 69804-004_1eca3776-0aa5-3e05-e054-00144ff8d46c 69804-004 HUMAN OTC DRUG Yowch for minor burns by Pain Balm lidocaine hcl CREAM TOPICAL 20150907 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 20 mg/1000mg E 20171231 69804-005_1ecb86ad-ebb0-634f-e054-00144ff88e88 69804-005 HUMAN OTC DRUG Yowch for insect bites and stings by Pain Balm lidocaine hcl CREAM TOPICAL 20150907 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 20 mg/1000mg E 20171231 69804-006_24fefc91-ea23-2f9a-e054-00144ff8d46c 69804-006 HUMAN OTC DRUG Yowch Extra Strength for minor burns Lidocaine HCL CREAM TOPICAL 20151130 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg E 20171231 69804-007_2500b265-fb35-167f-e054-00144ff88e88 69804-007 HUMAN OTC DRUG Yowch extra strength for insect bites and stings lidocaine hcl CREAM TOPICAL 20151130 OTC MONOGRAPH NOT FINAL part348 ridge properties llc LIDOCAINE HYDROCHLORIDE 40 mg/1000mg E 20171231 69804-008_2ebdfffc-c9ce-31df-e054-00144ff88e88 69804-008 HUMAN OTC DRUG Naturally HL Extra Strength Bedsore Numbing Lidocaine HCL CREAM TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg E 20171231 69804-009_2ebdfffc-c9be-31df-e054-00144ff88e88 69804-009 HUMAN OTC DRUG Naturally HL Extra Strength Bedsore Numbing lidocaine LIQUID TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg E 20171231 69804-010_2ebeee6e-bc68-43ee-e054-00144ff8d46c 69804-010 HUMAN OTC DRUG Naturally HL Extra Strength Burn Numbing Lidocaine HCL CREAM TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg E 20171231 69804-011_2ebeee6e-bc58-43ee-e054-00144ff8d46c 69804-011 HUMAN OTC DRUG Naturally HL Extra Strength Burn Numbing lidocaine LIQUID TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg E 20171231 69804-012_2ebf89d1-eda7-698f-e054-00144ff8d46c 69804-012 HUMAN OTC DRUG Naturally HL Extra Strength Numbing Lidocaine HCL CREAM TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg E 20171231 69804-013_2ebf89d1-ed97-698f-e054-00144ff8d46c 69804-013 HUMAN OTC DRUG Naturally HL Extra Strength Numbing lidocaine LIQUID TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg E 20171231 69804-014_2ebfa680-5d55-6d5e-e054-00144ff8d46c 69804-014 HUMAN OTC DRUG Naturally HL Extra Strength Hemorrhoid Numbing Lidocaine HCL CREAM TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg E 20171231 69804-015_2ebf89d1-ed99-698f-e054-00144ff8d46c 69804-015 HUMAN OTC DRUG Naturally HL Extra Strength Hemorrhoid Numbing lidocaine LIQUID TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg E 20171231 69804-016_2ec01016-d7d4-0b90-e054-00144ff88e88 69804-016 HUMAN OTC DRUG Naturally HL Extra Strength Insect Bite Numbing Lidocaine HCL CREAM TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg E 20171231 69804-017_2ebfa680-5d48-6d5e-e054-00144ff8d46c 69804-017 HUMAN OTC DRUG Naturally HL Extra Strength Insect Bite Numbing lidocaine LIQUID TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg E 20171231 69804-018_5daa3e1f-da15-c4d0-e053-2a91aa0a55dc 69804-018 HUMAN OTC DRUG Extra Strength PreTAT Lidocaine HCL GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-019_5de411bf-26d1-cda6-e053-2a91aa0a0e92 69804-019 HUMAN OTC DRUG Extra Strength PreTAT Lidocaine HCL GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-020_4575ee30-eb63-5dc9-e054-00144ff88e88 69804-020 HUMAN OTC DRUG Extra Strength AfterTAT Slime Lidocaine HCLt GEL TOPICAL 20170113 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-021_45ae0ceb-a13d-362f-e054-00144ff8d46c 69804-021 HUMAN OTC DRUG Extra Strength Numbing Gel Lidocaine HCL GEL TOPICAL 20170113 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-022_45ae4eaa-db0f-5483-e054-00144ff88e88 69804-022 HUMAN OTC DRUG Extra Strength Liquid Numbing Gel Lidocaine HCL GEL TOPICAL 20170113 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-023_45aebead-6455-58a7-e054-00144ff8d46c 69804-023 HUMAN OTC DRUG Extra Strength Liquid Bedsore Relief Gel Lidocaine HCL GEL TOPICAL 20170113 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-024_45af14e2-153d-6f05-e054-00144ff88e88 69804-024 HUMAN OTC DRUG Extra Strength Liquid Hemorrhoid Relief Gel Lidocaine HCL GEL TOPICAL 20170113 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-025_45af8201-c069-0763-e054-00144ff88e88 69804-025 HUMAN OTC DRUG Extra Strength Liquid Insect Bite Relief Gel Lidocaine HCL GEL TOPICAL 20170113 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-026_45afe10a-671d-12cd-e054-00144ff88e88 69804-026 HUMAN OTC DRUG Extra Strength Liquid Burn Relief Gel lidocaine hcl GEL TOPICAL 20170113 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-027_46640e6f-9165-0b17-e054-00144ff8d46c 69804-027 HUMAN OTC DRUG Extra Strength Naturally HL Foot Care lidocaine hcl CREAM TOPICAL 20170120 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-028_46647f8a-53be-11c1-e054-00144ff88e88 69804-028 HUMAN OTC DRUG extra strength naturally hl foot care lidocaine hcl LIQUID TOPICAL 20170120 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-029_4664c594-8143-2e4b-e054-00144ff8d46c 69804-029 HUMAN OTC DRUG extra strength foot care liquid gel lidocaine hcl GEL TOPICAL 20170120 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-030_46cb8329-886f-4593-e054-00144ff88e88 69804-030 HUMAN OTC DRUG Naturally HL Extra Strength Hand Care lidocaine hcl CREAM TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-031_46db3452-2352-5981-e054-00144ff88e88 69804-031 HUMAN OTC DRUG extra strength naturally hl hand care lidocaine hcl SPRAY TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-032_46dcd61a-ca9b-703a-e054-00144ff8d46c 69804-032 HUMAN OTC DRUG extra strength naturally hl hand care lidocaine hcl GEL TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-033_476a6775-798f-1076-e054-00144ff88e88 69804-033 HUMAN OTC DRUG extra strength naturally hl itch relief lidocaine hcl CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-034_47a4ebc2-a4a6-741f-e054-00144ff88e88 69804-034 HUMAN OTC DRUG extra strength naturally hl itch relief lidocaine hcl SPRAY TOPICAL 20170203 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-035_47a5f944-3cdd-5825-e054-00144ff8d46c 69804-035 HUMAN OTC DRUG extra strength naturally hl itch relief lidocaine hcl GEL TOPICAL 20170203 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-036_47f59fa0-026e-6116-e054-00144ff88e88 69804-036 HUMAN OTC DRUG Extra Strength Naturally HL Warming Ice lidocaine hcl CREAM TOPICAL 20170209 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-038_47f655d4-e40c-3988-e054-00144ff8d46c 69804-038 HUMAN OTC DRUG extra strength naturally hl warming ice lidocaine hcl GEL TOPICAL 20170209 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-039_4820e1ed-e9ba-0ad7-e054-00144ff88e88 69804-039 HUMAN OTC DRUG extra strength sunburn relief lidocaine hcl CREAM TOPICAL 20170210 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-040_4821f59f-4f9e-155d-e054-00144ff8d46c 69804-040 HUMAN OTC DRUG extra strength naturally hl sunburn relief lidocaine hcl LIQUID TOPICAL 20170210 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-041_48226591-e8e4-29b4-e054-00144ff8d46c 69804-041 HUMAN OTC DRUG extra strength naturally hl sunburn relief lidocaine hcl GEL TOPICAL 20170210 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-042_4c0b52af-ac66-54d7-e054-00144ff88e88 69804-042 HUMAN OTC DRUG extra strength postpartum relief lidocaine hcl CREAM TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-043_4c0bf2ff-1d75-6589-e054-00144ff88e88 69804-043 HUMAN OTC DRUG extra strength postpartum relief lidocaine hcl SPRAY TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 ridge properteis LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-044_4c0d490d-421e-6547-e054-00144ff8d46c 69804-044 HUMAN OTC DRUG Extra Strength Postpartum Relief lidocaine hcl GEL TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-045_4c0d9919-cc43-2508-e054-00144ff88e88 69804-045 HUMAN OTC DRUG Extra Strength Pruritis Care lidocaine hcl CREAM TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-046_4c0e6871-1e82-26b1-e054-00144ff8d46c 69804-046 HUMAN OTC DRUG Extra Strength Pruritis Relief lidocaine hcl SPRAY TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-047_4c0eea91-171f-4038-e054-00144ff8d46c 69804-047 HUMAN OTC DRUG Extra Strength Pruritis Relief lidocaine hcl GEL TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-048_4c0f172e-260b-539a-e054-00144ff88e88 69804-048 HUMAN OTC DRUG Extra Strength Skin Repair lidocaine hcl CREAM TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-049_4c0fceba-d854-641f-e054-00144ff88e88 69804-049 HUMAN OTC DRUG Extra Strength Skin Repair lidocaine hcl SPRAY TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-050_4c0ff804-b6bf-07a2-e054-00144ff8d46c 69804-050 HUMAN OTC DRUG Extra Strength Skin repair lidocaine hcl GEL TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-051_4d019a4f-6f0f-6961-e054-00144ff88e88 69804-051 HUMAN OTC DRUG Extra Strength Skin Repair lidocaine hcl CREAM TOPICAL 20170414 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-052_4d106348-89d3-649f-e054-00144ff88e88 69804-052 HUMAN OTC DRUG Extra Strength First Aid lidocaine hcl CREAM TOPICAL 20170414 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-053_4d106348-89ec-649f-e054-00144ff88e88 69804-053 HUMAN OTC DRUG Extra Strength First Aid lidocaine hcl GEL TOPICAL 20170414 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-054_4e2e7072-cfbf-437b-e054-00144ff88e88 69804-054 HUMAN OTC DRUG Extra Strength Wound Care lidocaine hcl CREAM TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 Ridge Proeprties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-055_4e2e7072-cfd3-437b-e054-00144ff88e88 69804-055 HUMAN OTC DRUG Extra Strength Wound Care lidocaine hcl SPRAY TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-056_4e2dd8bb-9321-6178-e054-00144ff8d46c 69804-056 HUMAN OTC DRUG Extra Strength Wound Care lidocaine hcl GEL TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-057_4e3d1eac-4f9a-6a8d-e054-00144ff8d46c 69804-057 HUMAN OTC DRUG Extra Strength Postherpetic Neuralgia Care Lidocaine HCL CREAM TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-058_4e3d8b7b-56fa-0dbd-e054-00144ff8d46c 69804-058 HUMAN OTC DRUG Extra Strength Postherpetic Neuralgia lidocaine HCL SPRAY TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-059_4e3e6450-3691-043a-e054-00144ff88e88 69804-059 HUMAN OTC DRUG Extra Strength Postherpetic Neuralgia Relief Lidocaine HCL GEL TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-060_4e3f0f1d-68c3-5313-e054-00144ff8d46c 69804-060 HUMAN OTC DRUG Extra Strength Shingle Chickenpox Relief Lidocaine HCL CREAM TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-061_4e3f5ab9-0413-21ac-e054-00144ff88e88 69804-061 HUMAN OTC DRUG Extra Strength Shingles Chickenpox Relief Lidocaine HCL SPRAY TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 Ridge Properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-062_4e400aef-05bf-2aea-e054-00144ff88e88 69804-062 HUMAN OTC DRUG Extra Strength Shingles Chickenpox Relief Lidocaine HCL GEL TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-063_4e409317-cef5-3e19-e054-00144ff88e88 69804-063 HUMAN OTC DRUG Extra Strength Scar Prevention Lidocaine HCL CREAM TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-064_4e40e9e8-d5b6-508f-e054-00144ff88e88 69804-064 HUMAN OTC DRUG Extra Strength Scar Prevention Lidocaine HCL SPRAY TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-065_4e413764-ec0e-5c4b-e054-00144ff88e88 69804-065 HUMAN OTC DRUG Extra Strength Scar Prevention Lidocaine HCL GEL TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-066_5a976364-35e1-6c29-e053-2a91aa0a00cc 69804-066 HUMAN OTC DRUG Numbify Tropical Gold Lidocaine HCL CREAM TOPICAL 20170529 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-067_5a97f68c-74a9-6aa8-e053-2991aa0a406d 69804-067 HUMAN OTC DRUG Numbify Tropical Gold Lidocaine HCL SPRAY TOPICAL 20170529 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-068_5a97f2c7-7e40-7a7d-e053-2991aa0ab96b 69804-068 HUMAN OTC DRUG Numbify Tropical Gold Lidocaine HCL GEL TOPICAL 20170529 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-069_5a983881-1a42-fe23-e053-2a91aa0a12dc 69804-069 HUMAN OTC DRUG Numbify Tropical Gold Lidocaine HCL GEL TOPICAL 20170529 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-070_5de4df6d-385d-7209-e053-2a91aa0a83a9 69804-070 HUMAN OTC DRUG Superior pain and itch relief lidocaine hcl CREAM TOPICAL 20171127 OTC MONOGRAPH NOT FINAL part348 ridge properties llc LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-071_5de53e2c-a092-2182-e053-2991aa0af9c6 69804-071 HUMAN OTC DRUG Superior pain and itch relief lidocaine hcl LIQUID TOPICAL 20171127 OTC MONOGRAPH NOT FINAL part348 ridge properties llc LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-072_5de5c4be-9615-5911-e053-2991aa0a33fe 69804-072 HUMAN OTC DRUG superior pain and itch relief lidocaine hcl GEL TOPICAL 20171127 OTC MONOGRAPH NOT FINAL part348 ridge properties llc LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-073_5de634c9-3e71-3bbf-e053-2991aa0a0f93 69804-073 HUMAN OTC DRUG Superior pain and itch relief lidocaine hcl GEL TOPICAL 20171127 OTC MONOGRAPH NOT FINAL part348 ridge properties llc LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-074_5de6d210-7c1d-a255-e053-2991aa0a322f 69804-074 HUMAN OTC DRUG Sore Relief lidocaine hcl CREAM TOPICAL 20171127 OTC MONOGRAPH NOT FINAL part348 ridge properties llc LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-075_5df6ff37-a4f1-d666-e053-2991aa0a9786 69804-075 HUMAN OTC DRUG Sore relief lidocaine hcl LIQUID TOPICAL 20171127 OTC MONOGRAPH NOT FINAL part348 ridge properties llc LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-076_5df7c687-ca1d-7f2a-e053-2a91aa0a85f4 69804-076 HUMAN OTC DRUG sore relief lidocaine hcl GEL TOPICAL 20171127 OTC MONOGRAPH NOT FINAL part348 ridge properties llc LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-077_5df7d5a9-e4ce-1b8e-e053-2a91aa0a4ffa 69804-077 HUMAN OTC DRUG Sore Relief lidocaine hcl GEL TOPICAL 20171127 OTC MONOGRAPH NOT FINAL part348 ridge properties llc LIDOCAINE HYDROCHLORIDE 40 mg/1000mg N 20181231 69804-078_60cb9cd7-9879-cadb-e053-2991aa0aaa9e 69804-078 HUMAN OTC DRUG Extra Strength Numbify Anorectal lidocaine hcl CREAM TOPICAL 20171231 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 50 mg/1000mg N 20181231 69804-079_60cccf15-9e42-5a59-e053-2a91aa0a2a19 69804-079 HUMAN OTC DRUG Extra Strength Numbify Anorectal lidocaine hcl SPRAY TOPICAL 20171231 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 50 mg/1000mg N 20181231 69804-081_60cd5a90-2587-2a84-e053-2991aa0a7c7a 69804-081 HUMAN OTC DRUG Extra Strength Numbify Anorectal lidocaine hcl GEL TOPICAL 20171231 OTC MONOGRAPH NOT FINAL part348 ridge properties LIDOCAINE HYDROCHLORIDE 50 mg/1000mg N 20181231 69805-786_2881e205-7b02-4e57-98a7-c33ef671a26f 69805-786 HUMAN OTC DRUG Zensa Lidocaine CREAM TOPICAL 20160104 OTC MONOGRAPH FINAL part346 Alera Skin Care Products Inc. LIDOCAINE 5 g/100g N 20181231 69808-1001_64c2f6b2-a002-438f-87c2-da453953f910 69808-1001 HUMAN OTC DRUG REVAGAIN Hair and Scalp revitalizing PYRITHIONE ZINC SHAMPOO TOPICAL 20150507 OTC MONOGRAPH FINAL part358H AFFINITY GROUP L.L.C. PYRITHIONE ZINC 2.1 g/100mL E 20171231 69808-2001_4eac257f-ecdc-49e0-8450-0a778b9899f8 69808-2001 HUMAN OTC DRUG REVAGAIN Scalp Tonic ALLANTOIN LIQUID TOPICAL 20150507 OTC MONOGRAPH FINAL part347 AFFINITY GROUP L.L.C. ALLANTOIN .3 g/100mL E 20171231 69809-0126_4745070e-5c09-3ccd-daf8-74df1b553946 69809-0126 HUMAN PRESCRIPTION DRUG Clozaril clozapine TABLET ORAL 20160506 NDA NDA019758 HLS Therapeutics (USA), Inc. CLOZAPINE 25 mg/1 Atypical Antipsychotic [EPC] N 20191231 69809-0127_4745070e-5c09-3ccd-daf8-74df1b553946 69809-0127 HUMAN PRESCRIPTION DRUG Clozaril clozapine TABLET ORAL 20160506 NDA NDA019758 HLS Therapeutics (USA), Inc. CLOZAPINE 100 mg/1 Atypical Antipsychotic [EPC] N 20191231 69811-101_aa61b02a-6e1f-47a1-9563-4574310ce56e 69811-101 HUMAN OTC DRUG DAILY TOUCH PETROLEUM Petrolatum JELLY TOPICAL 20150505 OTC MONOGRAPH FINAL part347 D.J.H. INC PETROLATUM 100 g/100g E 20171231 69811-102_45e9660f-52dd-4896-a255-91347a61c529 69811-102 HUMAN OTC DRUG DAILY TOUCH PETROLEUM WITH ALOE VERA Petrolatum JELLY TOPICAL 20150505 OTC MONOGRAPH FINAL part347 D.J.H. INC PETROLATUM 99 g/100g E 20171231 69811-103_1d37ae9c-b4cb-4e8d-8ecd-5892816ea454 69811-103 HUMAN OTC DRUG DAILY TOUCH PETROLEUM WITH COCOA BUTTER Petrolatum JELLY TOPICAL 20150505 OTC MONOGRAPH FINAL part347 D.J.H. INC PETROLATUM 99 g/100g E 20171231 69811-201_1d76e1d6-d3af-41cf-ab55-c0606e8655b8 69811-201 HUMAN OTC DRUG MORE SAVINGS RUBBING ALCOHOL 50 PERCENT ISOPROPYL ALCOHOL LIQUID TOPICAL 20150505 OTC MONOGRAPH NOT FINAL part333A D.J.H. INC ISOPROPYL ALCOHOL 50 mL/100mL E 20171231 69811-202_72bbee4a-a48e-4245-bd67-659ac9254280 69811-202 HUMAN OTC DRUG MORE SAVINGS 50 PERCENT ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL LIQUID TOPICAL 20150505 OTC MONOGRAPH NOT FINAL part333A D.J.H. INC ISOPROPYL ALCOHOL 50 mL/100mL E 20171231 69812-0001_91dfb151-847e-49c1-877e-3e80b6d56471 69812-0001 HUMAN OTC DRUG Trauma Formula Symphytum Officinale, Bellis Perennis, Hypericum Perforatum, Magnesia Phosphorica, Ruta Graveolens, Arnica Montana LIQUID ORAL 20150901 UNAPPROVED HOMEOPATHIC Beaute Therapies, Inc. COMFREY ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA 3; 12; 12; 30; 30; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69815-754_db117a28-f553-4c60-b531-79a3498b62f1 69815-754 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20150408 ANDA ANDA208679 Memorial Sloan Kettering Cancer Center FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 69817-0201_552a998c-bfa3-0288-e054-00144ff88e88 69817-0201 HUMAN PRESCRIPTION DRUG AlloPAX Levocetirizine dihydrochloride 5%, Loratadine 5% KIT 20150630 UNAPPROVED DRUG OTHER PharmaGenetico LLC N 20181231 69820-001_824a4454-fab4-4f45-a70b-4de15ce094be 69820-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20150427 UNAPPROVED MEDICAL GAS Motor City Hospital & Surgical Supply OXYGEN 99 L/100L E 20171231 69821-001_50e3961d-8266-31be-e054-00144ff8d46c 69821-001 HUMAN OTC DRUG Antibacterial Wet Wipes benzalkonium chloride SWAB TOPICAL 20150506 OTC MONOGRAPH NOT FINAL part333A Zhejiang Qimei Commodity Co.,Ltd. BENZALKONIUM CHLORIDE .13 g/100g N 20181231 69822-100_80511a9d-56e5-43a6-abf0-c71068389f29 69822-100 HUMAN OTC DRUG Ice Quake Menthol GEL TOPICAL 20120823 OTC MONOGRAPH NOT FINAL part348 Southern Sales & Service, Inc. MENTHOL 16.95 g/113g N 20181231 69822-101_123a99fb-ae66-4c70-b1fc-5c0c622f39d7 69822-101 HUMAN OTC DRUG Ice Quake Plus Methyl Salicylate, Menthol, Camphor CREAM TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Southern Sales & Service, Inc. MENTHOL; METHYL SALICYLATE; CAMPHOR (SYNTHETIC) 10; 10; 3.1 g/100g; g/100g; g/100g N 20181231 69822-102_56500d99-4e66-49cb-9c84-6cce9d04fe58 69822-102 HUMAN OTC DRUG Ice Quake Roll On MENTHOL CAMPHOR (NATURAL) GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part348 Southern Sales & Service, Inc. MENTHOL; CAMPHOR (NATURAL) 3.5; .2 g/100mL; g/100mL N 20181231 69822-103_964d33e9-2d07-4ca6-882d-a2c0303b4f7d 69822-103 HUMAN OTC DRUG ICE MUSCLE RUB Leon M.C Menthol GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Southern Sales & Service, Inc. MENTHOL 2 g/100g N 20191231 69822-104_ca98f08c-d020-443b-9cea-98df303b1e49 69822-104 HUMAN OTC DRUG ICE QUAKE MUSCLE RUB Blue Menthol GEL TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part348 Southern Sales & Service, Inc. MENTHOL 2 g/100g N 20181231 69822-200_4d6fade3-09cc-4dba-b3cf-4ccdc4434e18 69822-200 HUMAN OTC DRUG AKIN GUAIFENESIN SOLUTION ORAL 20150101 OTC MONOGRAPH FINAL part341 Southern Sales & Service, Inc. GUAIFENESIN 100 mg/5mL N 20181231 69822-201_96983bd8-a669-4e01-8c5d-d27b95acf742 69822-201 HUMAN OTC DRUG Akin DM DEXTROMETHORPHAN GUAIFENESIN LIQUID ORAL 20140104 OTC MONOGRAPH FINAL part341 Southern Sales & Service, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 69822-300_4f4ef4ba-863e-4428-9fc6-6c31918e8f88 69822-300 HUMAN OTC DRUG ICE QUAKE Analgesic Cream White Methyl Salicylate and Menthol CREAM TOPICAL 20161001 OTC MONOGRAPH NOT FINAL part348 Southern Sales & Service, Inc. METHYL SALICYLATE; MENTHOL 8; 2 1/1; 1/1 N 20181231 69825-001_85e6cf14-8fd5-44d5-a8ae-b9460ff6eab8 69825-001 HUMAN OTC DRUG Osteodin-Z Dulcamara, Amica Montana, Ruta gravelolens, Rhus toxicodendron, Actaea racemosa, Formica rufa LIQUID ORAL 20150518 UNAPPROVED HOMEOPATHIC Adven Biotech Private Limited SOLANUM DULCAMARA TOP; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; FORMICA RUFA; ACTAEA RACEMOSA WHOLE; ARNICA MONTANA 3; 4; 4; 4; 4; 3 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL E 20171231 69825-002_30894917-1cf2-1200-e054-00144ff88e88 69825-002 HUMAN OTC DRUG folli plus Acidum Fluoricum, Acidum Phosphoricum, Natrum Muriaticum, Calcarea Phosphate, Badiaga TABLET ORAL 20160328 UNAPPROVED HOMEOPATHIC Adven Biotech Private Limited PHOSPHORIC ACID; HYDROFLUORIC ACID; CALCIUM PHOSPHATE; SPONGILLA LACUSTRIS; SODIUM CHLORIDE 3; 6; 3; 3; 3 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg E 20171231 69825-003_2ae64e09-670f-6f7f-e054-00144ff8d46c 69825-003 HUMAN OTC DRUG osteodin-z Rhus toxicondendron, hypericum perforatum, ruta graveolens, bellis perrnnis, methyl salicylate, menthol OINTMENT TOPICAL 20160208 UNAPPROVED HOMEOPATHIC Adven Biotech Private Limited HYPERICUM PERFORATUM; RUTA GRAVEOLENS WHOLE; BELLIS PERENNIS; TOXICODENDRON PUBESCENS LEAF; MENTHOL .36; .36; .36; 2.25; .18 g/30g; g/30g; g/30g; g/30g; g/30g E 20171231 69825-005_2efb2514-e162-09f2-e054-00144ff8d46c 69825-005 HUMAN OTC DRUG d-acne berberis aquifolium, thuja occidentalis, calendula officinalis OINTMENT TOPICAL 20160328 UNAPPROVED HOMEOPATHIC Adven Biotech Private Limited THUJA OCCIDENTALIS ROOT; MAHONIA AQUIFOLIUM ROOT; CALENDULA OFFICINALIS FLOWER 1; 1; 1 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g E 20171231 69825-006_2f3d404d-d020-0466-e054-00144ff8d46c 69825-006 HUMAN OTC DRUG laxease Phenolphthalein, Senna, Sulphur TABLET ORAL 20160330 UNAPPROVED HOMEOPATHIC Adven Biotech Private Limited PHENOLPHTHALEIN; SENNA LEAF; SULFUR 81.6; 9.2; 9.2 g/100g; g/100g; g/100g E 20171231 69825-007_2f74679b-c611-229f-e054-00144ff88e88 69825-007 HUMAN OTC DRUG rolfia Crataegus Oxy, Passiflore Inc, Rauwolfia Ser, Kali Brom TABLET ORAL 20160330 UNAPPROVED HOMEOPATHIC Adven Biotech Private Limited POTASSIUM BROMIDE; CRATAEGUS MONOGYNA LEAF; PASSIFLORA INCARNATA ROOT; RAUWOLFIA SERPENTINA 3; 2; 2; 2 [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g E 20171231 69831-0001_161c467e-ba2f-5404-e054-00144ff8d46c 69831-0001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20150515 OTC MONOGRAPH NOT FINAL part333E Laser Graphics Inc. ALCOHOL 62 mL/100mL N 20181231 69833-011_41a21ee8-6884-447d-893d-1c44f4aaba33 69833-011 HUMAN OTC DRUG Solmara Menthol, Unspecified Form and Lidocaine PATCH TOPICAL 20150720 OTC MONOGRAPH NOT FINAL part348 Spring Hill Therapeutics LLC MENTHOL, UNSPECIFIED FORM; LIDOCAINE 5; 4 g/1; g/1 E 20171231 69836-1001_0fdba3d6-8d40-4d35-b41a-4f0e47e3f030 69836-1001 HUMAN OTC DRUG Oriental Fermented GLYCERIN SOAP TOPICAL 20150617 OTC MONOGRAPH FINAL part347 International Nature Soap Institute GLYCERIN 8 g/100g N 20181231 69836-2001_68add368-55df-4a23-a0f3-b71b3da7f4b7 69836-2001 HUMAN OTC DRUG Illite Whitening GLYCERIN SOAP TOPICAL 20150617 OTC MONOGRAPH FINAL part347 International Nature Soap Institute GLYCERIN 8 g/100g N 20181231 69836-3001_d1aa27ed-6766-4ac0-b415-b63266546b1f 69836-3001 HUMAN OTC DRUG Olive 75% Marseille GLYCERIN SOAP TOPICAL 20150617 OTC MONOGRAPH FINAL part347 International Nature Soap Institute GLYCERIN 12 g/100g N 20181231 69836-4001_30e4ce56-7ffa-1093-e054-00144ff88e88 69836-4001 HUMAN OTC DRUG 75% Olive Oil Marseille GLYCERIN SOAP TOPICAL 20150617 OTC MONOGRAPH FINAL part347 International Nature Soap Institute GLYCERIN 15 g/100g N 20181231 69836-5001_3f1f8aa1-8100-2aac-e054-00144ff8d46c 69836-5001 HUMAN OTC DRUG INIbebe Organic Soapberry Wash GLYCERIN LIQUID TOPICAL 20151019 OTC MONOGRAPH FINAL part347 International Nature Soap Institute GLYCERIN 15 g/100mL N 20181231 69837-003_4004c502-a197-48c0-aa12-15781fa07007 69837-003 HUMAN PRESCRIPTION DRUG Sure ResultTAC Pak TRIAMCINOLONE ACETONIDE, DIMETHICONE KIT 20160202 ANDA ANDA088042 International Brand Management, LLC E 20171231 69837-010_25383117-5f5a-4ecb-bd6b-98e7cd1b6218 69837-010 HUMAN PRESCRIPTION DRUG Home PapKit HYDROCORTISONE CREAM TOPICAL 20160915 ANDA ANDA085027 International Brand Management, LLC HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 69837-019_6b074006-0212-4147-a5fa-2b1b85b1fb1f 69837-019 HUMAN OTC DRUG AMPlify Relief MM METHYL SALICYLATE, MENTHOL CREAM TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part348 International Brand Management, LLC METHYL SALICYLATE; MENTHOL 3; 1 g/10g; g/10g N 20181231 69837-100_2f67c1a5-08b9-4c52-a0a9-44ce5e3e8942 69837-100 HUMAN PRESCRIPTION DRUG PainGo KFT PRILOCAINE, LIDOCAINE, METHYL SALICYLATE, MENTHOL KIT 20170126 ANDA ANDA076453 International Brand Management, LLC N 20181231 69837-170_6fe820c3-0ed6-4fc9-a64e-35f6e0c85fce 69837-170 HUMAN PRESCRIPTION DRUG OMEGA-3-ACID ETHYL ESTERS OMEGA-3-ACID ETHYL ESTERS CAPSULE ORAL 20160409 ANDA ANDA090973 International Brand Management Inc OMEGA-3-ACID ETHYL ESTERS 1 g/g Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 69837-210_6a8ca084-49e3-4518-bf2c-4480fb6c2fe2 69837-210 HUMAN OTC DRUG Sure Relief SR Relief CAPSAICIN CREAM TOPICAL 20160310 OTC MONOGRAPH NOT FINAL part348 International Brand Management, LLC CAPSAICIN .025 mg/.001g E 20171231 69837-310_8b911631-65c0-4f92-8e0d-eae041ac595c 69837-310 HUMAN OTC DRUG SR Renew DIMETHICONE CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part347 International Brand Management, LLC DIMETHICONE 50 mg/mL E 20171231 69837-399_64428c78-3a2b-4e81-a1a2-b411c485ebe3 69837-399 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION TOPICAL 20160204 ANDA ANDA202027 International Brand Management, LLC DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 69837-410_42185d03-a597-4d90-806e-91c311461cb3 69837-410 HUMAN OTC DRUG Sure Result SR Renew DIMETHICONE CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part347 International Brand Management, LLC DIMETHICONE 50 mg/mL N 20181231 69837-500_8477df57-624b-42cf-847d-ea9bfa296fbd 69837-500 HUMAN PRESCRIPTION DRUG Sure Result DSS Premium Pak DICLOFENAC SODIUM, CAPSAICIN KIT 20160210 ANDA ANDA202027 International Brand Management, LLC E 20171231 69837-510_843515b8-434a-4c37-a54c-da0dc912afa4 69837-510 HUMAN OTC DRUG Sure Result SR Relief CAPSAICIN CREAM TOPICAL 20160310 OTC MONOGRAPH NOT FINAL part348 International Brand Management, LLC CAPSAICIN .025 mg/.001g N 20181231 69837-700_8dc0e6fb-fd78-4e95-adb1-91e64de5a3da 69837-700 HUMAN PRESCRIPTION DRUG Sure Result O3D3 System OMEGA-3-ACID ETHYL ESTERS KIT 20160305 ANDA ANDA090973 International Brand Management, LLC E 20171231 69838-001_5606f799-b62d-4e62-87c8-5f88558734e8 69838-001 HUMAN OTC DRUG haircop hairDANBI NATURAL PANTHENOL, SALICYLIC ACID SHAMPOO TOPICAL 20150519 UNAPPROVED DRUG OTHER The Nature Co., Ltd. PANTHENOL; SALICYLIC ACID .5; .5 g/500g; g/500g E 20171231 69840-001_8541bad4-5831-479e-bc3c-ac4fcc886a80 69840-001 HUMAN OTC DRUG Blemish Clearing Facial Wipes Salicylic Acid CLOTH TOPICAL 20150520 OTC MONOGRAPH FINAL part358H Yes To Inc. SALICYLIC ACID 10 mg/1 N 20181231 69840-002_d0642d47-9262-4475-b31f-4771fae01ae7 69840-002 HUMAN OTC DRUG Yes To Coconut Eczema Relief Hydrocortisone CREAM TOPICAL 20150609 OTC MONOGRAPH NOT FINAL part348 Yes To Incorporated HYDROCORTISONE 10 mg/mL E 20171231 69840-003_d7f725b6-643b-45bb-aa1e-fcf84fed01c1 69840-003 HUMAN OTC DRUG Yes To Tomatoes Detoxifying Charcoal Cleanser Salicylic Acid CREAM TOPICAL 20150609 OTC MONOGRAPH FINAL part358H Yes To Incorporated SALICYLIC ACID 10 mg/mL N 20181231 69840-004_d8b6a22c-a0e1-4a2a-a3b3-6d94b405e8ca 69840-004 HUMAN OTC DRUG Yes To Tomatoes Acne Clearing Facial Toner Salicylic Acid LIQUID TOPICAL 20150611 OTC MONOGRAPH FINAL part358H Yes To Incorporated SALICYLIC ACID 5 mg/mL N 20181231 69840-005_d1dc7325-37c8-453b-8c82-7ff6b75d31da 69840-005 HUMAN OTC DRUG Yes To Tomatoes Detoxifying Charcoal Mud Mask Salicylic Acid CREAM TOPICAL 20150611 OTC MONOGRAPH FINAL part358H Yes To Incorporated SALICYLIC ACID 5 mg/mL N 20181231 69840-006_6cd08a56-74a5-4805-9554-d2ae216286a8 69840-006 HUMAN OTC DRUG Yes to Natural Man Broad Spectrum SPF 15 Face Zinc Oxide and Titanium Dioxide CREAM TOPICAL 20151201 OTC MONOGRAPH FINAL part352 Yes To Inc. ZINC OXIDE; TITANIUM DIOXIDE 32; 29 mg/mL; mg/mL E 20171231 69840-007_23e8001e-4aeb-468e-988c-58df90403de1 69840-007 HUMAN OTC DRUG Yes To Tomatoes Acne Fighting Paper Mask Salicylic Acid CLOTH TOPICAL 20160601 OTC MONOGRAPH FINAL part358H Yes To Incorporated SALICYLIC ACID 5 mg/mL N 20181231 69840-008_7a9b4438-33bf-42db-ade1-1a24d2cc9256 69840-008 HUMAN OTC DRUG Yes To Tomatoes Detoxifying Charcoal Sleeping Mask Salicylic Acid CREAM TOPICAL 20170615 OTC MONOGRAPH FINAL part358H Yes To Incorporated SALICYLIC ACID 5 mg/mL N 20181231 69840-009_5b970d62-3124-49a4-9035-5700c401507b 69840-009 HUMAN OTC DRUG Yes To Tomatoes Micellar Cleansing Water Salicylic Acid LOTION TOPICAL 20170615 OTC MONOGRAPH FINAL part358H Yes To Incorporated SALICYLIC ACID 5 mg/mL N 20181231 69841-030_15fdc18a-1272-3fef-e054-00144ff8d46c 69841-030 HUMAN OTC DRUG Stream2Sea Broad Spectrum 30 Titanium Dioxide LOTION TOPICAL 20150701 OTC MONOGRAPH FINAL part352 Debut Development, LLC TITANIUM DIOXIDE 1 g/.88mL E 20171231 69842-000_bea9a732-4994-1343-5fb5-57c0bbdeed1a 69842-000 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160725 ANDA ANDA208150 CVS Pharmacy FLUTICASONE PROPIONATE 50 ug/1 N 20181231 69842-001_32faa020-8072-bf6e-5bbf-7281320c1d5b 69842-001 HUMAN OTC DRUG Budesonide Budesonide SPRAY, METERED NASAL 20160409 ANDA ANDA078949 CVS Pharmacy BUDESONIDE 32 ug/1 N 20181231 69842-002_c0aa2a31-97d4-45ba-9d87-feef09f0057b 69842-002 HUMAN OTC DRUG Daytime and Nighttime Pain Relief Acetaminophen, Diphenhydramine HCl KIT 20151209 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy, Inc. N 20181231 69842-005_e7d598f7-a6f3-4b27-ad47-bb900c6a584c 69842-005 HUMAN OTC DRUG STOMACH RELIEF MAXIMUM STRENGTH Bismuth Subsalicylate LIQUID ORAL 20160120 OTC MONOGRAPH FINAL part335 CVS Pharmacy, Inc. BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 69842-006_3b20f86b-f0a5-4980-b1cd-31bbf3d8ff2f 69842-006 HUMAN OTC DRUG CVS - Childrens Mucus Relief Cough, Cold and Sore Throat Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine hydrochloride SOLUTION ORAL 20160503 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL N 20181231 69842-008_04a09e91-8c07-4043-95d4-053af7fdc0a4 69842-008 HUMAN OTC DRUG Sore Mouth Cleanser Hydrogen Peroxide MOUTHWASH TOPICAL 20120203 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc HYDROGEN PEROXIDE 1588 mg/mL N 20181231 69842-009_174a02b3-ad34-42b5-9115-309641dd6185 69842-009 HUMAN OTC DRUG Daytime and Nighttime Cough Relief Dextromethorphan HBr, Guaifenesin, Dextromethorphan HBr, Doxylamine Succinate KIT 20160502 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. N 20181231 69842-010_373dd4f6-ef87-4b67-896f-308fa77f5fdd 69842-010 HUMAN OTC DRUG naproxen sodium Naproxen Sodium TABLET, FILM COATED ORAL 20160315 ANDA ANDA074661 CVS Pharmacy NAPROXEN SODIUM 220 mg/1 N 20181231 69842-011_71821d56-3b49-49bd-8a73-a866c24056aa 69842-011 HUMAN OTC DRUG Body Menthol POWDER TOPICAL 20131203 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc MENTHOL 1.5 mg/g N 20181231 69842-012_77dd3c49-ed7c-438e-b458-862bde17d19d 69842-012 HUMAN OTC DRUG Cold and Cough Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170413 OTC MONOGRAPH FINAL part341 CVS PHARMACY, INC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 10; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 69842-014_6991b8a3-8ab7-4169-905f-9d7437beadf7 69842-014 HUMAN OTC DRUG Chest Congestion and Cough HBP Dextromethorphan hydrobromide, Guaifenesin CAPSULE, LIQUID FILLED ORAL 20170413 OTC MONOGRAPH FINAL part341 CVS PHARMACY, INC. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 N 20181231 69842-015_5dec7bb7-ac4f-43d4-b815-f48f0a612b8b 69842-015 HUMAN OTC DRUG Childrens Antacid Extra Strength Calcium carbonate TABLET, CHEWABLE ORAL 20160509 OTC MONOGRAPH FINAL part331 CVS Pharmacy,Inc CALCIUM CARBONATE 750 mg/1 N 20181231 69842-017_e6e972a9-298c-488a-b9fc-2bcce75c289b 69842-017 HUMAN OTC DRUG Allergy Relief Chlorpheniramine Maleate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100615 ANDA ANDA040829 CVS Pharmacy CHLORPHENIRAMINE MALEATE 12 mg/1 N 20181231 69842-018_2711c46c-71ef-4989-9423-f3a204aded16 69842-018 HUMAN OTC DRUG Daytime Congestion Pressure and Pain acetaminophen, phenylephrine hydrochloride CAPSULE, LIQUID FILLED ORAL 20170413 OTC MONOGRAPH FINAL part341 CVS PHARMACY, INC. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 69842-020_bd875b9c-46e9-fd4c-eb59-241795d549c1 69842-020 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160915 ANDA ANDA208150 CVS Pharmacy FLUTICASONE PROPIONATE 50 ug/1 N 20181231 69842-021_869054ce-7c49-458f-95b0-7a042ed0adbb 69842-021 HUMAN OTC DRUG SkinPharmacy Advanced Sun Therapy Broad Spectrum SPF 50 Face homosalate, oxybenzone, octisalate, avobenzone, octocrylene LIQUID TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 CVS Health HOMOSALATE; OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 100; 60; 50; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-022_60a54a3a-98ed-4ece-999a-75df89236947 69842-022 HUMAN OTC DRUG SkinPharmacy Advanced Anti-Aging Therapy Retinol Day Moisturizer SPF 30 homosalate, octisalate, avobenzone, octocrylene, oxybenzone LIQUID TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 CVS Health HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE; OXYBENZONE 100; 50; 20; 15; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-023_7792c247-8fcd-4031-9940-c226c9c79dff 69842-023 HUMAN OTC DRUG SkinPharmacy Advanced Acne Therapy Spot Treatment benzoyl peroxide LIQUID TOPICAL 20140601 OTC MONOGRAPH FINAL part333D CVS Health BENZOYL PEROXIDE 50 mg/mL N 20181231 69842-027_551ec593-ac51-6833-fd26-0570cc60539a 69842-027 HUMAN OTC DRUG Omeprazole Magnesium Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20111101 ANDA ANDA078878 CVS Health Corp. OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 69842-030_5140ca7f-2651-4e67-9f2e-f141749b5720 69842-030 HUMAN OTC DRUG ADV 3N1 EXFOL CVS Benzoyl Peroxide 5.00% CREAM TOPICAL 20131216 OTC MONOGRAPH FINAL part333D CVS BENZOYL PEROXIDE 5 g/100g N 20181231 69842-031_9fe8c303-765e-4887-b1eb-403cdfe27c92 69842-031 HUMAN OTC DRUG CRMY ACNE WASH CVS Benzoyl Peroxide 4.00% CREAM TOPICAL 20141126 OTC MONOGRAPH FINAL part333D CVS BENZOYL PEROXIDE 4 g/100g N 20181231 69842-032_e5fb1d65-41d2-4c8c-80cd-a0c13a28633a 69842-032 HUMAN OTC DRUG FT CRM MENTHL CVS Menthol 10.00% CREAM TOPICAL 20130815 OTC MONOGRAPH NOT FINAL part348 CVS MENTHOL 10 g/100g N 20181231 69842-033_4a78b5f1-a6bb-4dd2-b689-2991718fd1e2 69842-033 HUMAN OTC DRUG LIP BALM MINT CVS Avobenzone 2.00% Homosalate 15.00% Octisalate 5.00% Octinoxate 7.50% STICK TOPICAL 20141218 OTC MONOGRAPH FINAL part352 CVS AVOBENZONE; HOMOSALATE; OCTISALATE; OCTINOXATE 2; 15; 5; 7.5 g/100g; g/100g; 1/100g; g/100g N 20181231 69842-034_da5a20c7-56bd-4afd-bae4-5aad58898762 69842-034 HUMAN OTC DRUG LIP BALM SPF30 CVS Avobenzone 2.00% Homosalate 15.00% Octisalate 5.00% Octinoxate 7.50% STICK TOPICAL 20140217 OTC MONOGRAPH FINAL part352 CVS AVOBENZONE; HOMOSALATE; OCTISALATE; OCTINOXATE 2; 15; 5; 7.5 g/100g; g/100g; g/100g; g/100g N 20181231 69842-035_6157a96d-d019-1742-e053-2991aa0ae2f9 69842-035 HUMAN OTC DRUG ACNE FM WSH MX CVS Benzoyl Peroxide 10% CREAM TOPICAL 20120615 OTC MONOGRAPH FINAL part333D CVS BENZOYL PEROXIDE 10 g/100g N 20181231 69842-036_4ebf0c74-7975-4de7-849a-5073fa0b2dd3 69842-036 HUMAN OTC DRUG ZINC SPF30 LTN CVS Titanium Dioxide 3.67% Zinc Oxide 3.50% LOTION TOPICAL 20140314 OTC MONOGRAPH FINAL part352 CVS TITANIUM DIOXIDE; ZINC OXIDE 3.67; 3.5 g/100mL; g/100mL N 20181231 69842-038_047a7a0f-e340-4230-9929-90ddfdf64491 69842-038 HUMAN OTC DRUG ITCH RELIF CVS Diphenhydramine HYDROCHLORIDE GEL TOPICAL 20140214 OTC MONOGRAPH NOT FINAL part348 CVS DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100mL N 20181231 69842-039_5e49a43a-a39c-44e1-a373-187d52d26d10 69842-039 HUMAN OTC DRUG EAR WAX RMVL CVS Carbamide Peroxide 6.5% LIQUID AURICULAR (OTIC) 20141224 OTC MONOGRAPH FINAL part344 CVS CARBAMIDE PEROXIDE 6.5 g/100mL N 20181231 69842-041_0dc97168-281b-4187-a54a-67eab90d5e3b 69842-041 HUMAN OTC DRUG EARWAX REM CVS Carbamide Peroxide 6.50% KIT 20100514 OTC MONOGRAPH FINAL part344 CVS N 20181231 69842-042_07b0bb01-eb45-4646-a599-0df2b73aabd7 69842-042 HUMAN OTC DRUG CVS EARWAX REM CVS Carbamide Peroxide 6.50% KIT 20141112 OTC MONOGRAPH FINAL part344 CVS N 20181231 69842-044_d4415c86-661b-49c2-8d96-bf4ba60329c2 69842-044 HUMAN OTC DRUG Oil Free Acne Scrub CVS Salicylic Acid 2.00% LOTION TOPICAL 20100115 OTC MONOGRAPH FINAL part333D CVS SALICYLIC ACID 2 g/100mL N 20181231 69842-045_a31c91d0-7472-41d4-bdb8-c784c6fc07ba 69842-045 HUMAN OTC DRUG Retinol Day SPF 30 CVS Avobenzone 3.00% Octinoxate 7.50% Octisalate 5.00% Octocrylene 2.70% Oxybenzone 4.00% CREAM TOPICAL 20141226 OTC MONOGRAPH NOT FINAL part352 CVS AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69842-046_889fd417-dc1f-472b-84a7-3c01fbd1f42d 69842-046 HUMAN OTC DRUG Acne Treatment maximum strength CVS Resorcinol 2.00% Sulfur 8.00% CREAM TOPICAL 20141226 OTC MONOGRAPH FINAL part333D CVS RESORCINOL; SULFUR 2; 8 g/100g; g/100g N 20181231 69842-047_43e6f421-b205-4159-9155-4ffa24b835f9 69842-047 HUMAN OTC DRUG Triple Antibiotic CVS Bacitracin, Neomycin, Polymyxin OINTMENT TOPICAL 20140214 OTC MONOGRAPH FINAL part333B CVS NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN 3.5; 500; 400 mg/g; U/g; U/g N 20181231 69842-048_00b0c0f0-0fb3-4bcc-898a-c4827845bf39 69842-048 HUMAN OTC DRUG Vanishing Acne CVS 10% Benzoyl Peroxide acne medication CREAM TOPICAL 20131213 OTC MONOGRAPH FINAL part333D CVS BENZOYL PEROXIDE 10 g/100g N 20181231 69842-049_fd586fb6-df2e-4c92-98e1-b5aa7f963433 69842-049 HUMAN OTC DRUG Pain Relief CVS Lidocaine 4% LIQUID TOPICAL 20170131 OTC MONOGRAPH NOT FINAL part348 CVS LIDOCAINE 4 g/100mL N 20181231 69842-050_f356763d-3c6a-46d2-885c-c5de13a02764 69842-050 HUMAN OTC DRUG Burn Relief CVS Lidocaine 4% LIQUID TOPICAL 20170216 OTC MONOGRAPH NOT FINAL part348 CVS LIDOCAINE 4 g/100mL N 20181231 69842-051_61455eae-bcb2-3851-e053-2a91aa0a6d37 69842-051 HUMAN OTC DRUG Hydrating Protection Sunscreen SPF 50 CVS Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 6.00% Oxybenzone 5.00% LOTION TOPICAL 20170216 OTC MONOGRAPH FINAL part352 CVS AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 6; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69842-052_80a61daa-f32f-bf30-9e49-511c9f8ecc4d 69842-052 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine hydrochloride TABLET ORAL 20110401 ANDA ANDA076502 CVS Health Corp. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 69842-053_3987b3d5-61b7-484e-b5cb-64321a5bc35e 69842-053 HUMAN OTC DRUG Pain Relief CVS Lidocaine HCI LIQUID TOPICAL 20170131 OTC MONOGRAPH NOT FINAL part348 CVS LIDOCAINE HYDROCHLORIDE 4 g/100mL N 20181231 69842-054_2a7620c4-d556-40be-b1c3-f76598a1eb31 69842-054 HUMAN OTC DRUG Hydrating Protection Sunscreen CVS Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0% Oxybenzone 6.0% LOTION TOPICAL 20170216 OTC MONOGRAPH FINAL part352 CVS AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69842-055_14eae8b8-5f47-4fd1-bd34-68c65bdf1f84 69842-055 HUMAN OTC DRUG Hydrating Protection Sunscreen SPF 30 CVS Avobenzone 3.00% Homosalate 8.00% Octisalate 4.00% Octocrylene 4.00% Oxybenzone 5.00% LOTION TOPICAL 20170216 OTC MONOGRAPH FINAL part352 CVS AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 8; 4; 4; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69842-057_c60e2501-0c15-4cb0-8373-da32f0972d09 69842-057 HUMAN OTC DRUG Mucus DM Extended Release Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 CVS Pharmacy, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 600; 30 mg/1; mg/1 N 20191231 69842-058_dba58892-fd3f-44a7-ade6-17333844b05f 69842-058 HUMAN OTC DRUG CVS Health Diaper Rash Zinc Oxide OINTMENT TOPICAL 20100331 OTC MONOGRAPH FINAL part347 CVS Health ZINC OXIDE 400 mg/g N 20181231 69842-059_028c245d-fd84-4687-aaa5-de7df20d1b52 69842-059 HUMAN OTC DRUG Maximum Strength Mucus DM Extended Release Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 CVS Pharmacy, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20191231 69842-060_540899f4-cc24-4b11-895b-addff93ccb7c 69842-060 HUMAN OTC DRUG Antacid Extra Strength Wintergreen Calcium carbonate TABLET, CHEWABLE ORAL 20150401 OTC MONOGRAPH FINAL part331 CVS CALCIUM CARBONATE 750 mg/1 N 20181231 69842-064_7e7500ac-ddbd-4f11-bdea-5a0ba5f34096 69842-064 HUMAN OTC DRUG SKIN PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSER salicylic acid LIQUID TOPICAL 20140701 OTC MONOGRAPH FINAL part333D CVS Health SALICYLIC ACID 20 mg/mL N 20181231 69842-065_8381d820-c27a-48ef-9d01-e9540c49362e 69842-065 HUMAN OTC DRUG CVS Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20140530 OTC MONOGRAPH FINAL part347 CVS Health ZINC OXIDE 200 mg/g N 20181231 69842-066_aca57bce-04c3-47ee-ad55-0c0957e12453 69842-066 HUMAN OTC DRUG SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID salicylic acid LIQUID TOPICAL 20140501 OTC MONOGRAPH FINAL part333D CVS Health SALICYLIC ACID 20 mg/mL N 20181231 69842-067_c6218db0-9871-4176-a9a8-f22485d60ee7 69842-067 HUMAN OTC DRUG Age Renewal Firming and Hydrating Moisturizer SPF 30 octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide LOTION TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 CVS Health OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 60; 50; 40; 39; 20 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69842-068_baf4d896-375c-41e3-926f-739f09d72d84 69842-068 HUMAN OTC DRUG Maximum Strength Gas Relief Simethicone CAPSULE, LIQUID FILLED ORAL 20161213 OTC MONOGRAPH FINAL part332 CVS PHARMACY, INC. DIMETHICONE 250 mg/1 N 20181231 69842-069_c9679e78-94c3-4c67-9b27-0b9ce723deec 69842-069 HUMAN OTC DRUG DAY Cold and Flu Plus and NIGHTTIME Cold and Flu Plus acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride KIT 20161213 OTC MONOGRAPH FINAL part341 CVS PHARMACY, INC. N 20181231 69842-070_f9e89cf8-2f31-404d-bf8f-dd781ff30bfc 69842-070 HUMAN OTC DRUG CVS Daytime COLD and FLU RELIEF and Nighttime COLD and FLU RELIEF acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride KIT 20161213 OTC MONOGRAPH FINAL part341 CVS PHARMACY, INC. N 20181231 69842-071_cf195dcc-7557-4b4e-bd8d-140ad35ffbe0 69842-071 HUMAN OTC DRUG Maximum Strength Nighttime Cold/Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCI CAPSULE, LIQUID FILLED ORAL 20161214 OTC MONOGRAPH FINAL part341 CVS PHARMACY, INC. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 69842-072_a12012be-3025-4fd5-b026-2d20b3101ca2 69842-072 HUMAN OTC DRUG STOOL SOFTENER DOCUSATE SODIUM 50 MG DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20161214 OTC MONOGRAPH NOT FINAL part334 CVS PHARMACY, INC. DOCUSATE SODIUM 50 mg/1 N 20181231 69842-073_dafb5382-decc-49fd-9401-8cce60784086 69842-073 HUMAN OTC DRUG Pain Relief Extra Strength ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20161214 OTC MONOGRAPH NOT FINAL part343 CVS PHARMACY, INC. ACETAMINOPHEN 500 mg/1 N 20181231 69842-074_3bc10c76-25b5-4c13-85c4-15cbd2a68829 69842-074 HUMAN OTC DRUG Daytime Sinus Relief and Nighttime Sinus Relief acetaminophen, doxylamine succinate, phenylephrine hydrochloride KIT 20161214 OTC MONOGRAPH FINAL part341 CVS PHARMACY, INC. N 20181231 69842-075_b3525ec6-13b1-485e-ae7f-4cba6730771d 69842-075 HUMAN OTC DRUG Regular Strength Pain Relief ACETAMINOPHEN CAPSULE, LIQUID FILLED ORAL 20161229 OTC MONOGRAPH NOT FINAL part343 CVS PHARMACY, INC. ACETAMINOPHEN 325 mg/1 N 20181231 69842-076_cfadec28-3acb-4c75-8489-1e3e3e798353 69842-076 HUMAN OTC DRUG SkinPharmacy Advanced Acne Therapy Active Clearing benzoyl peroxide LIQUID TOPICAL 20140601 OTC MONOGRAPH FINAL part333D CVS Health BENZOYL PEROXIDE 25 mg/mL N 20181231 69842-077_94fc9904-3118-4e9f-8e1f-a640f2cfbfa8 69842-077 HUMAN OTC DRUG SKINPHARMACY ADVANCED ACNE THERAPY PORE REFINING FACIAL MASK salicylic acid LIQUID TOPICAL 20160701 OTC MONOGRAPH FINAL part333D CVS Health SALICYLIC ACID 5 mg/mL N 20181231 69842-078_76fd610d-0991-40ee-8492-2a00eb555223 69842-078 HUMAN OTC DRUG Skin Pharmacy Advanced Sun Therapy Broad Spectrum SPF 30 Sun Homosalate, Octisalate, Avobenzone, Oxybenzone, Octocrylene LIQUID TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 CVS Health HOMOSALATE; OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE 40; 40; 30; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-079_551d728f-ceca-4e0f-a46c-5055e1090b2b 69842-079 HUMAN OTC DRUG SkinPharmacy Advanced Anti-Aging Therapy Glycolic Day Moisturizer SPF 30 homosalate, octisalate, avobenzone, octocrylene, oxybenzone LOTION TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 CVS Health HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE; OXYBENZONE 100; 50; 30; 20; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-080_16872f78-fbf7-4de9-b9f3-6f5361bd3dfd 69842-080 HUMAN OTC DRUG Beauty 360 Accelerated Wrinkle Repair Moisturizer homosalate, octisalate, avobenzone, octocrylene LIQUID TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 CVS Health HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 40; 40; 20; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-081_d00668ab-878f-41cf-b6b4-22adeb50e99b 69842-081 HUMAN OTC DRUG SkinPharmacy Advanced Acne Therapy Targeted Treatment Wipes benzoyl peroxide SWAB TOPICAL 20140501 OTC MONOGRAPH FINAL part333D CVS Health BENZOYL PEROXIDE 25 mg/mL N 20181231 69842-082_80cecb53-6a09-4802-95fd-8d4130be8aa7 69842-082 HUMAN OTC DRUG SkinPharmacy Advanced Acne Therapy Kit salicylic acid, benzoyl peroxide KIT TOPICAL 20141001 OTC MONOGRAPH FINAL part333D CVS Health N 20181231 69842-083_51e197be-8f55-40e7-ba69-f81ba388c08e 69842-083 HUMAN OTC DRUG Sport Sunstick SPF 30 Sunscreen avobenzone, octinoxate, octisalate STICK TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 CVS Health AVOBENZONE; OCTINOXATE; OCTISALATE 20; 75; 30 mg/g; mg/g; mg/g N 20181231 69842-090_ddee4aa7-ca96-4f63-b99c-3ea1e9f44e89 69842-090 HUMAN OTC DRUG ARNICA CVS Arnica montana GEL TOPICAL 20170301 UNAPPROVED HOMEOPATHIC CVS Health ARNICA MONTANA 1 [hp_X]/g N 20181231 69842-098_603d4383-3f97-4214-e053-2a91aa0ad2c1 69842-098 HUMAN OTC DRUG CVS Ear Drops for Swimmers Isopropyl Alcohol LIQUID AURICULAR (OTIC) 20080101 OTC MONOGRAPH FINAL part344 CVS Pharmacy ISOPROPYL ALCOHOL 950 mg/mL N 20181231 69842-100_6f98718d-1334-43f3-8d58-0accd4c3072b 69842-100 HUMAN OTC DRUG Nighttime Cold and Flu Relief Alcohol Free Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr LIQUID ORAL 20160705 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 650; 4; 30 mg/30mL; mg/30mL; mg/30mL N 20181231 69842-101_47f7d794-7301-0fe5-e054-00144ff8d46c 69842-101 HUMAN OTC DRUG CVS Health Ultra Protection SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170109 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 70; 50; 130; 30; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-102_481b822d-23e0-4ea5-e054-00144ff88e88 69842-102 HUMAN OTC DRUG CVS Health Ultra Protection SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20170109 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE 50; 100; 30; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-103_47f7fa25-3e0a-1614-e054-00144ff8d46c 69842-103 HUMAN OTC DRUG CVS Health Sport SPF 50 Sun Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170110 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 130; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-104_33a3b243-4326-431c-8b28-b59fb04f00a2 69842-104 HUMAN OTC DRUG CVS Health Sport SPF 30 Clear Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170425 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 20; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-105_0e69cb3f-dfa9-4595-984b-36508b68f4c7 69842-105 HUMAN OTC DRUG CVS Health SPF 15 Clear Avobenzone, Homosalate, Octisalate, Oxybenzone AEROSOL, SPRAY TOPICAL 20170426 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 20; 100; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-106_68f5a4a7-8524-4bfe-8d20-414718f38613 69842-106 HUMAN OTC DRUG CVS Health Sport SPF 15 Clear Avobenzone, Homosalate, Octisalate, Oxybenzone AEROSOL, SPRAY TOPICAL 20170426 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 20; 100; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-107_45eac440-fb42-3509-e054-00144ff8d46c 69842-107 HUMAN OTC DRUG CVS Health Aftersun Aloe Vera Cooling Lidocaine GEL TOPICAL 20170112 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy LIDOCAINE 5 mg/g N 20181231 69842-108_456024c7-52a4-4f7a-ac20-e55f5cfd9eb4 69842-108 HUMAN OTC DRUG CVS Pharmacy Kids SPF 50 Clear Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170427 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-109_576eeff7-5f07-ca85-e053-2a91aa0a01ae 69842-109 HUMAN OTC DRUG CVS Health Baby SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170131 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; OXYBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE 30; 40; 130; 20; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69842-110_1e013960-ed27-4aa3-9e2f-ad4aff5bdc86 69842-110 HUMAN OTC DRUG CVS Health SPF 50 Clear Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170428 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-111_122502c0-caa2-47f2-8a41-02f7af9b3734 69842-111 HUMAN OTC DRUG CVS Health SPF 30 Clear Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170428 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 20; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-112_480f3b72-8f6f-1080-e054-00144ff88e88 69842-112 HUMAN OTC DRUG CVS Health SPF 55 Ultra Sheer Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170112 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 70; 30; 100; 30; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-113_48121458-3e84-2282-e054-00144ff8d46c 69842-113 HUMAN OTC DRUG CVS Health SPF 30 Oil Free Sun Avobenzone, Homosalate, Octinoxate, Octisalate STICK TOPICAL 20170112 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; HOMOSALATE; AVOBENZONE; OCTISALATE 75; 150; 20; 50 mg/g; mg/g; mg/g; mg/g N 20181231 69842-114_48135083-8063-06af-e054-00144ff8d46c 69842-114 HUMAN OTC DRUG CVS Health Sport SPF 50 Face Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170119 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 130; 50; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-115_4ea52119-aa69-185e-e054-00144ff8d46c 69842-115 HUMAN OTC DRUG CVS Health SPF 70 Sheer Mist Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170503 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 300; 1500; 500; 400; 600 mg/10g; mg/10g; mg/10g; mg/10g; mg/10g N 20181231 69842-116_5f24cb09-7d9f-485e-b242-255b2011af7f 69842-116 HUMAN OTC DRUG CVS Health Sport SPF 50 Clear Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170306 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-117_4822216a-f5b5-2048-e054-00144ff8d46c 69842-117 HUMAN OTC DRUG CVS Health SPF 50 Sun Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170123 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTISALATE; AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 50; 20; 90; 75; 15; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-118_46d9dd37-a8ce-4c01-e054-00144ff8d46c 69842-118 HUMAN OTC DRUG CVS Health SPF 30 Ultra Sheer Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20170124 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 75; 50; 70; 20; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-119_4822633a-5ef1-469f-e054-00144ff88e88 69842-119 HUMAN OTC DRUG CVS Health Age Defense SPF 70 Face Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170125 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 70; 30; 100; 30; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-120_4eb9b3dd-7377-5e3a-e054-00144ff8d46c 69842-120 HUMAN OTC DRUG CVS Health SPF 45 Sheer Mist Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170503 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 300; 1500; 500; 235; 600 mg/10g; mg/10g; mg/10g; mg/10g; mg/10g N 20181231 69842-121_4823e1e1-f8c3-4ab3-e054-00144ff8d46c 69842-121 HUMAN OTC DRUG CVS Health Acne Fighting Moisturizer Salicylic Acid LOTION TOPICAL 20170201 OTC MONOGRAPH FINAL part333D CVS Pharmacy SALICYLIC ACID 5 mg/mL N 20181231 69842-122_477b7c3b-a0e2-04c7-e054-00144ff88e88 69842-122 HUMAN OTC DRUG CVS Health SPF 45 Ultra Sheer Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 28; 50; 100; 30; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-123_576f4522-4b62-2c03-e053-2a91aa0a8cf9 69842-123 HUMAN OTC DRUG CVS Health 60 Plus Sensitive Skin Sun Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy TITANIUM DIOXIDE; ZINC OXIDE 49.39; 47.145 mg/mL; mg/mL N 20181231 69842-124_4eb824a6-66ad-01f8-e054-00144ff8d46c 69842-124 HUMAN OTC DRUG CVS Pharmacy Kids SPF 70 Clear Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170504 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-125_4783e94d-fe37-20ea-e054-00144ff88e88 69842-125 HUMAN OTC DRUG CVS Health SPF 100 Ultra Sheer Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170223 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 100; 50; 150; 30; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-126_5850b0ce-7891-4570-b417-aead1efd4e9b 69842-126 HUMAN OTC DRUG Chocolate Flavored Senna standardized senna concentrate TABLET, CHEWABLE ORAL 20150821 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy,Inc. SENNOSIDES 8.6 mg/1 N 20181231 69842-127_4eb75945-9d56-55b4-e054-00144ff88e88 69842-127 HUMAN OTC DRUG CVS Health SPF 70 Clear Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170504 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-128_34beab35-65b7-4419-851d-792daeee5801 69842-128 HUMAN OTC DRUG CVS Health Maximum Strength Feminine Pramoxine Hydrochloride CLOTH TOPICAL 20170126 OTC MONOGRAPH NOT FINAL part347 CVS Pharmacy PRAMOXINE HYDROCHLORIDE 1 mg/1 N 20181231 69842-129_4ec4d877-6e88-1c6b-e054-00144ff88e88 69842-129 HUMAN OTC DRUG CVS Health Sport SPF 70 Clear Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170505 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-130_4ec61e58-a89a-4a10-e054-00144ff88e88 69842-130 HUMAN OTC DRUG CVS Health Sport SPF 100 Plus Clear Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170505 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-131_4ec605b3-fe35-5c9c-e054-00144ff8d46c 69842-131 HUMAN OTC DRUG CVS Health SPF 100 Clear Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170505 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTINOXATE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 30; 150; 50; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-132_63f0cf27-9347-097d-e053-2a91aa0a3c50 69842-132 HUMAN OTC DRUG CVS Health Ultra Protection SPF 100 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 100; 50; 150; 30; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 69842-133_479055e4-ccff-534a-e054-00144ff8d46c 69842-133 HUMAN OTC DRUG CVS Pharmacy Beauty 360 SPF 15 7-in-1 Complete Daily Moisturizer Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20170511 OTC MONOGRAPH FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE 30; 50; 26; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-134_4790faf1-010c-6f4e-e054-00144ff8d46c 69842-134 HUMAN OTC DRUG CVS Health Childrens SPF 70 Plus Wet and Dry Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20191231 69842-135_6414a97c-6632-4c58-e053-2991aa0a704b 69842-135 HUMAN OTC DRUG CVS Pharmacy SPF 30 Wet and Dry Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 80; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20191231 69842-136_64154273-558e-0083-e053-2a91aa0a2777 69842-136 HUMAN OTC DRUG CVS Health SPF 85 Wet and Dry Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20191231 69842-137_540f8d6c-4476-2864-e054-00144ff88e88 69842-137 HUMAN OTC DRUG CVS Acne Cleansing Bar Benzoyl Peroxide SOAP TOPICAL 20160101 OTC MONOGRAPH FINAL part333D CVS BENZOYL PEROXIDE 100 mg/g N 20181231 69842-138_4832f02d-2897-2fe6-e054-00144ff8d46c 69842-138 HUMAN OTC DRUG CVS Health Baby SPF 50 Sun Octinoxate, Octisalate, Zinc Oxide LOTION TOPICAL 20170210 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTISALATE; OCTINOXATE; ZINC OXIDE 50; 75; 145 mg/mL; mg/mL; mg/mL N 20181231 69842-139_486dc178-0285-4ed1-e054-00144ff88e88 69842-139 HUMAN OTC DRUG CVS Health AM Moisturizing Facial Homosalate, Octinoxate, Zinc Oxide, Octocrylene LOTION TOPICAL 20170203 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; ZINC OXIDE; OCTINOXATE; HOMOSALATE 20; 34.125; 75; 120 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-140_4ec61e58-a8aa-4a10-e054-00144ff88e88 69842-140 HUMAN OTC DRUG CVS Health Sport SPF 50 Clear Avobenzone, Homosalate, Octisalate, Octocrylene, AEROSOL, SPRAY TOPICAL 20170505 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-141_4ec6b50b-5227-6f5b-e054-00144ff8d46c 69842-141 HUMAN OTC DRUG CVS Health Sport SPF 30 Clear Avobenzone, Homosalate, Octocrylene, AEROSOL, SPRAY TOPICAL 20170505 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTOCRYLENE 20; 70; 50 mg/mL; mg/mL; mg/mL N 20181231 69842-142_578631b9-9285-8c6e-e053-2a91aa0a79fd 69842-142 HUMAN OTC DRUG CVS Health SPF 50 Vanishing Zinc Sun Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20170203 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy ZINC OXIDE; TITANIUM DIOXIDE 48.3; 50.6 mg/g; mg/g N 20181231 69842-143_57867cd1-6df4-dbe8-e053-2a91aa0a3df8 69842-143 HUMAN OTC DRUG CVS Health SPF 50 Vanishing Zinc Sun Face Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20170203 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy ZINC OXIDE; TITANIUM DIOXIDE 48.3; 50.6 mg/g; mg/g N 20181231 69842-144_4ec72879-71f9-1d05-e054-00144ff8d46c 69842-144 HUMAN OTC DRUG CVS Pharmacy SPF 30 Beach Guard Clear Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170505 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 300; 800; 400; 200; 500 mg/10g; mg/10g; mg/10g; mg/10g; mg/10g N 20181231 69842-145_4ec7ab2d-277f-0337-e054-00144ff88e88 69842-145 HUMAN OTC DRUG CVS Pharmacy SPF 70 Beach Guard Clear Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170505 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 300; 1500; 500; 400; 600 mg/10g; mg/10g; mg/10g; mg/10g; mg/10g N 20181231 69842-146_4adbd2d6-8a14-36b4-e054-00144ff88e88 69842-146 HUMAN OTC DRUG CVS Pharmacy SPF 30 Beach Guard Sun Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170316 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 35; 50; 80; 27; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-147_4825d00e-5290-483e-e054-00144ff8d46c 69842-147 HUMAN OTC DRUG CVS Health Sport SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20170202 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE 50; 100; 30; 100 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-148_4adbd66a-6b39-046d-e054-00144ff8d46c 69842-148 HUMAN OTC DRUG CVS Health SPF 70 Beach Guard Sun Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20170316 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 45; 50; 100; 30; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-149_48272a2c-6451-2992-e054-00144ff8d46c 69842-149 HUMAN OTC DRUG CVS Pharmacy SPF 50 Beach Guard Sun Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20170203 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OXYBENZONE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE 30; 100; 150; 30; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69842-150_46c941d2-d52a-50c3-e054-00144ff8d46c 69842-150 HUMAN OTC DRUG CVS Oil-free Acne Cleansing Towelettes salicylic acid CLOTH TOPICAL 20170101 OTC MONOGRAPH FINAL part333D CVS pharmacy SALICYLIC ACID 20 mg/mL N 20181231 69842-151_4eb96bd1-98cf-2097-e054-00144ff88e88 69842-151 HUMAN OTC DRUG CVS Health SPF 30 Sheer Mist Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170504 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 300; 800; 400; 235; 500 mg/10g; mg/10g; mg/10g; mg/10g; mg/10g N 20181231 69842-152_4ec81e1c-f0e8-4529-e054-00144ff8d46c 69842-152 HUMAN OTC DRUG CVS Health SPF 30 Coconut Scented Clear Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170505 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 20; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-153_4ec87524-074e-5507-e054-00144ff8d46c 69842-153 HUMAN OTC DRUG CVS Health SPF 50 Coconut Scented Clear Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone AEROSOL, SPRAY TOPICAL 20170505 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 40; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69842-154_a8d9edb1-e28b-412e-9fc0-939b0d58c26f 69842-154 HUMAN OTC DRUG Athletes Foot tolnaftate SPRAY TOPICAL 20161111 OTC MONOGRAPH FINAL part333C CVS Pharmacy TOLNAFTATE 1 g/100g N 20181231 69842-155_f2d069a5-01ea-4533-bdf2-0c6c8cfd01a7 69842-155 HUMAN OTC DRUG CVS Health Hydrocortisone Anti Itch Hydrocortisone CREAM TOPICAL 20170428 OTC MONOGRAPH NOT FINAL part348 CVS Health HYDROCORTISONE 10 mg/g N 20181231 69842-156_a62bb946-8174-4a0e-9b34-ae5950d82aff 69842-156 HUMAN OTC DRUG Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20180205 OTC MONOGRAPH FINAL part338 CVS PHARMACY, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 69842-157_478eacb7-afc6-6203-e054-00144ff8d46c 69842-157 HUMAN OTC DRUG CVS Health Ultra Protection SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20180125 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 100; 50; 150; 30; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 69842-159_aabd3dea-bc1e-46fd-800b-35b559dc6f91 69842-159 HUMAN OTC DRUG CVS A and D All-Purpose Skin Protectant All-Purpose Skin Protectant OINTMENT TOPICAL 20110211 OTC MONOGRAPH FINAL part347 CVS Health PETROLATUM; LANOLIN 534; 155 mg/g; mg/g N 20181231 69842-160_3738d35c-1e83-40df-9292-c54e6b2c8353 69842-160 HUMAN OTC DRUG Childrens Pain Relief Acetaminophen TABLET, CHEWABLE ORAL 20171101 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy,Inc. ACETAMINOPHEN 160 mg/1 N 20181231 69842-161_5cc951e4-45bd-4c40-9d78-95f8233e7002 69842-161 HUMAN OTC DRUG CVS Health Triple Antibiotic with Pain Relief Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate and Pramoxine HCL OINTMENT TOPICAL 20170428 OTC MONOGRAPH FINAL part333B CVS Health BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE 500; 10000; 3.5; 10 [USP'U]/g; [USP'U]/g; mg/g; mg/g N 20181231 69842-162_7cf7e6a3-9aac-45ce-8e26-3ab9bb349aee 69842-162 HUMAN OTC DRUG CVS Health Triple Antibiotic Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate OINTMENT TOPICAL 20170428 OTC MONOGRAPH FINAL part333B CVS Health BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE 400; 5000; 3.5 [USP'U]/g; [USP'U]/g; mg/g N 20181231 69842-163_2295c6b6-1473-4b34-82c6-f069d1bd6aaf 69842-163 HUMAN OTC DRUG CVS Health Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20170428 OTC MONOGRAPH FINAL part333B CVS Health BACITRACIN ZINC 500 [USP'U]/g N 20181231 69842-164_63b420ba-ac5b-5670-e053-2a91aa0a864b 69842-164 HUMAN OTC DRUG CVS Health SPF 70 Sun Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part352 CVS Pharmacy OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE; OXYBENZONE 100; 50; 150; 30; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 69842-165_4b70706b-f348-463b-960e-b1259f8c37bb 69842-165 HUMAN OTC DRUG Ibuprofen PM IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED ORAL 20160930 ANDA ANDA090397 CVS Pharmacy IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE 200; 25 mg/1; mg/1 N 20191231 69842-167_603daf45-4029-350a-e053-2991aa0ac98c 69842-167 HUMAN OTC DRUG CVS Itch Relief and Repellent Benzocaine LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part348 CVS Pharmacy BENZOCAINE 50 mg/mL N 20181231 69842-171_ce8cfb77-e2d9-42a6-985c-534591993edb 69842-171 HUMAN OTC DRUG Ultra Strength Antacid Calcium Antacid TABLET, CHEWABLE ORAL 20111209 OTC MONOGRAPH FINAL part331 CVS CALCIUM CARBONATE 1000 mg/1 N 20181231 69842-172_16c744c8-fe46-4bb4-b272-1a51095acda0 69842-172 HUMAN OTC DRUG Stomach relief Bismuth subsalicylate TABLET ORAL 20110808 OTC MONOGRAPH FINAL part335 CVS BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 69842-173_e974ee4d-e008-4907-b46a-b088fa6f153a 69842-173 HUMAN OTC DRUG Extra Strength Smooth Antacid Assorted Fruit Calcium antacid TABLET, CHEWABLE ORAL 20141103 OTC MONOGRAPH FINAL part331 CVS CALCIUM CARBONATE 750 mg/1 N 20181231 69842-179_0bc335f1-1d13-4d54-9505-c7cb243d41c6 69842-179 HUMAN OTC DRUG After Dinner Antacid Calcium Carbonate,Magnesium hydroxide and Simethicone TABLET, CHEWABLE ORAL 20170315 OTC MONOGRAPH FINAL part331 CVS Pharmacy,Inc. CALCIUM CARBONATE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 270; 80 mg/1; mg/1; mg/1 N 20181231 69842-180_024f5a5f-60ed-4fde-a929-7f6d2080f308 69842-180 HUMAN OTC DRUG Sour Stomach Relief Antacid TABLET, CHEWABLE ORAL 20170616 OTC MONOGRAPH FINAL part331 CVS Pharmacy,Inc. CALCIUM CARBONATE 1000 mg/1 N 20181231 69842-184_3052bc73-94ed-4b29-9672-65a48a393d6e 69842-184 HUMAN OTC DRUG Antacid Extra Strength Assorted Berry Calcium carbonate TABLET, CHEWABLE ORAL 20150401 OTC MONOGRAPH FINAL part331 CVS CALCIUM CARBONATE 750 mg/1 N 20181231 69842-189_9299fe0a-3cd2-407d-aae0-f5295926a05a 69842-189 HUMAN OTC DRUG nasal decongestant Pseudoephedrine hydrochloride CAPSULE, GELATIN COATED ORAL 20170209 OTC MONOGRAPH FINAL part341 CVS Pharmacy PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 69842-193_624651a7-caf6-cf5d-e053-2a91aa0a5f3b 69842-193 HUMAN OTC DRUG Daily Fiber Psyllium Husks POWDER, FOR SOLUTION ORAL 20120913 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy, Inc. PSYLLIUM HUSK 3.4 g/5.8g N 20191231 69842-199_c2891ed8-80eb-46ac-96cb-f901894a7f8e 69842-199 HUMAN OTC DRUG Antibiotic bacitracin zinc, neomycin, polymyxin B OINTMENT TOPICAL 20160804 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 69842-200_46615295-ab26-5e73-e054-00144ff8d46c 69842-200 HUMAN OTC DRUG CVS First Aid Kit diphenhydramine hydrochloride, aspirin, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, benzalkonium chloride, ammonia, lidocaine, acetaminophen, ibuprofen, KIT TOPICAL 20161228 OTC MONOGRAPH NOT FINAL part333A CVS N 20181231 69842-207_60633036-b356-6696-e053-2991aa0ae09c 69842-207 HUMAN OTC DRUG CVS Decolorized Iodine Alcohol LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy ALCOHOL .48 mL/mL N 20181231 69842-209_5b1e83c8-e3b2-8793-e053-2991aa0ac79e 69842-209 HUMAN OTC DRUG CVS Eyewash Purified Water KIT TOPICAL 20171009 OTC MONOGRAPH FINAL part349 CVS N 20181231 69842-213_603df544-ca66-9c90-e053-2a91aa0acab2 69842-213 HUMAN OTC DRUG CVS Iodine Iodine, Sodium Iodide and Alcohol LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy IODINE; SODIUM IODIDE; ALCOHOL 20; 20.4; 470 mg/mL; mg/mL; mg/mL N 20181231 69842-219_93f5baf1-f7c3-4e9c-ae90-cb470e3a1c51 69842-219 HUMAN OTC DRUG Natural Daily Fiber Psyllium Husk CAPSULE ORAL 20170614 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy,Inc. PSYLLIUM HUSK .52 g/1 N 20181231 69842-219_bb4fcb37-baec-4663-9ae8-6b7aeaba6374 69842-219 HUMAN OTC DRUG Natural Daily Fiber Psyllium Husk CAPSULE ORAL 20170614 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy,Inc. PSYLLIUM HUSK .52 g/1 N 20181231 69842-222_9fb1abb0-1382-4d5d-a514-9ca5177d8ae6 69842-222 HUMAN OTC DRUG Pain Relief CVS Lidocaine HCI CREAM TOPICAL 20160315 OTC MONOGRAPH NOT FINAL part348 CVS LIDOCAINE HYDROCHLORIDE 4 g/100g N 20181231 69842-223_b86a2235-db99-4705-b604-085834cf0bd9 69842-223 HUMAN OTC DRUG Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170405 ANDA ANDA075077 CVS Pharmacy ACETAMINOPHEN 650 mg/1 N 20181231 69842-232_7fdc2f3e-fbf0-4fbe-aa8c-21bb7b4c4420 69842-232 HUMAN OTC DRUG Anticavity Fluoride Sodium Fluoride MOUTHWASH ORAL 20170130 OTC MONOGRAPH FINAL part355 CVS Pharmacy SODIUM FLUORIDE .1 mg/mL N 20181231 69842-233_b8d880e0-487c-4589-8835-1b6e83ed784c 69842-233 HUMAN OTC DRUG Cold and Flu Plus Acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate KIT 20170721 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 69842-241_6444c6df-111c-07d5-e053-2991aa0ac219 69842-241 HUMAN OTC DRUG CVS Health Alcohol Swabsticks Isopropyl alcohol SWAB TOPICAL 20180202 OTC MONOGRAPH FINAL part344 CVS Pharmacy ISOPROPYL ALCOHOL 70 mL/100mL N 20191231 69842-250_49da5655-28ac-09cf-e054-00144ff8d46c 69842-250 HUMAN OTC DRUG CVS Health Lice Killing Piperonyl butoxide, Pyrethrum extract SHAMPOO TOPICAL 20101028 OTC MONOGRAPH FINAL part358G CVS PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL N 20181231 69842-251_c6f41188-1b60-413e-87c1-cd3c7a10d1c8 69842-251 HUMAN OTC DRUG CVS Pharmacy Restore and Defend Fluoride PASTE, DENTIFRICE DENTAL 20141001 OTC MONOGRAPH FINAL part355 CVS Pharmacy STANNOUS FLUORIDE .454 g/100g N 20181231 69842-253_ca4fd1e7-6716-4da6-aad7-2b50d61b9fab 69842-253 HUMAN OTC DRUG CVS Pharmacy Dry Mouth Fluoride PASTE, DENTIFRICE DENTAL 20151001 OTC MONOGRAPH FINAL part355 CVS Pharmacy SODIUM FLUORIDE .243 g/100g N 20181231 69842-255_49cd21fc-282f-103b-e054-00144ff88e88 69842-255 HUMAN OTC DRUG CVS 3 Step Lice Solution Piperonyl butoxide, Pyrethrum extract KIT TOPICAL 20101028 OTC MONOGRAPH FINAL part358 CVS N 20181231 69842-256_49da2c40-afc6-5770-e054-00144ff88e88 69842-256 HUMAN OTC DRUG CVS Vapor Steam camphor (synthetic) LIQUID RESPIRATORY (INHALATION) 20111102 OTC MONOGRAPH FINAL part341 CVS CAMPHOR (SYNTHETIC) .623 g/10mL N 20181231 69842-264_8f44491f-f9cd-4ec7-b6e5-5850ee35818f 69842-264 HUMAN OTC DRUG Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20160819 OTC MONOGRAPH FINAL part341 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69842-271_4843cda5-1e50-4369-84fd-25d0fdc0a475 69842-271 HUMAN OTC DRUG Ultra Strength Antacid Assorted Berries Calcium carbonate TABLET, CHEWABLE ORAL 20111209 OTC MONOGRAPH FINAL part331 CVS CALCIUM CARBONATE 1000 mg/1 N 20181231 69842-272_47e4be23-c1f0-4b12-a3a1-9ff04f64352d 69842-272 HUMAN OTC DRUG CVS Pharmacy Always White Fluoride PASTE, DENTIFRICE DENTAL 20161001 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy SODIUM FLUORIDE; POTASSIUM NITRATE .25; 5 g/100g; g/100g N 20181231 69842-278_5f9a8c9d-0773-1398-e053-2a91aa0a07d5 69842-278 HUMAN OTC DRUG MILK OF MAGNESIA magnesium hydroxide LIQUID ORAL 20150701 OTC MONOGRAPH NOT FINAL part334 CVS MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 69842-281_9e26a0fb-cf8e-4523-b541-23164153ae5c 69842-281 HUMAN OTC DRUG CVS Pharmacy Strong White Fluoride PASTE, DENTIFRICE DENTAL 20180101 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy SODIUM FLUORIDE; POTASSIUM NITRATE .25; 5 g/100g; g/100g N 20191231 69842-286_5f880b43-2978-7a2d-e053-2991aa0a024d 69842-286 HUMAN OTC DRUG REGULAR STRENGTH ANTACID aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20150601 OTC MONOGRAPH FINAL part331 CVS ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 69842-296_3ce054f3-2954-5f7d-e054-00144ff8d46c 69842-296 HUMAN OTC DRUG MAXIMUM STRENGTH ANTACID MINT aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20150601 OTC MONOGRAPH FINAL part331 CVS ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 69842-300_490dddc6-05a2-2726-e054-00144ff8d46c 69842-300 HUMAN OTC DRUG CVS All Purpose First Aid Kit aspirin, diphenhydramine hydrochloride, aspirin, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, benzalkonium chloride, ammonia, lidocaine, acetaminophen, ibuprofen, KIT TOPICAL 20161228 OTC MONOGRAPH NOT FINAL part333A CVS N 20181231 69842-301_374e7c96-103f-4cb5-8def-ca5d2889804b 69842-301 HUMAN OTC DRUG CVS Arthritis Pain Relief Arthritis Pain Relief CREAM TOPICAL 20160530 OTC MONOGRAPH NOT FINAL part348 CVS Health HISTAMINE DIHYDROCHLORIDE .025 g/100g N 20181231 69842-302_49c5bd9a-c45e-72d7-e054-00144ff88e88 69842-302 HUMAN OTC DRUG Acetaminophen Acetaminophen CAPSULE ORAL 20151102 OTC MONOGRAPH NOT FINAL part343 CVS PHARMACY, INC ACETAMINOPHEN 500 mg/1 N 20181231 69842-303_5bffd877-8097-5fc5-e053-2a91aa0a8ead 69842-303 HUMAN OTC DRUG Acetaminophen Dextromethorphan HBr Doxylamine succinate Phenylephrine HCl Acetaminophen Dextromethorphan HBr Doxylamine succinate Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20171130 OTC MONOGRAPH FINAL part341 CVS PHARMACY, INC DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE 10; 325; 5; 6.25 mg/1; mg/1; mg/1; mg/1 N 20181231 69842-304_5bd761be-9e27-6aa7-e053-2991aa0ab380 69842-304 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20170818 OTC MONOGRAPH FINAL part338 CVS PHARMACY, INC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69842-305_54ae55e0-1f4a-072e-e054-00144ff88e88 69842-305 HUMAN OTC DRUG Acetaminophen Dextromethorphan HBr Doxylamine succinate Phenylephrine HCl Acetaminophen Dextromethorphan HBr Doxylamine Succinate Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20170707 OTC MONOGRAPH FINAL part341 CVS PHARMACY,INC DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 10; 325; 6.25; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 69842-310_46e66d2c-5703-404a-8ce2-b5513da0967e 69842-310 HUMAN OTC DRUG SENNA-S DOCUSATE SODIUM and SENNOSIDES CAPSULE, GELATIN COATED ORAL 20170210 OTC MONOGRAPH NOT FINAL part334 CVS DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 69842-311_c96a7fe0-994d-49cf-8e58-2971679870ad 69842-311 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, FILM COATED ORAL 20171222 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 N 20191231 69842-314_63eabc79-dc71-4e07-b61b-b933ad507e39 69842-314 HUMAN OTC DRUG CVS Antibacterial Plus Urinary Pain Relief METHENAMINE, SODIUM SALICYLATE TABLET ORAL 20170222 UNAPPROVED DRUG OTHER CVS Pharmacy, Inc METHENAMINE; SODIUM SALICYLATE 162; 162.5 mg/1; mg/1 N 20181231 69842-318_5f9ac9d9-fe87-1e38-e053-2991aa0aa2a6 69842-318 HUMAN OTC DRUG MILK OF MAGNESIA CHERRY magnesium hydroxide LIQUID ORAL 20150701 OTC MONOGRAPH NOT FINAL part334 CVS MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 69842-323_3b066e4e-2170-4d3b-ae9f-6a1e23212abf 69842-323 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20160413 ANDA ANDA074937 CVS Pharmacy IBUPROFEN 100 mg/5mL N 20191231 69842-325_603e1291-97f3-b907-e053-2a91aa0a6d22 69842-325 HUMAN OTC DRUG CVS Povidone-Iodine Povidone Iodine LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy POVIDONE-IODINE 100 mg/mL N 20181231 69842-332_5f9a57f1-bb5a-c9b4-e053-2a91aa0a4608 69842-332 HUMAN OTC DRUG MILK OF MAGNESIA CHERRY magnesium hydroxide LIQUID ORAL 20150701 OTC MONOGRAPH NOT FINAL part334 CVS MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 69842-340_fe8b8eae-d323-47d6-afc9-60e927bd9609 69842-340 HUMAN OTC DRUG Antacid aluminum hydroxide, magnesium hydroxide, simethicone SUSPENSION ORAL 20160612 OTC MONOGRAPH FINAL part331 CVS Pharmacy ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 800; 800; 80 mg/10mL; mg/10mL; mg/10mL N 20181231 69842-342_35431983-aef3-07ba-e054-00144ff88e88 69842-342 HUMAN OTC DRUG ADVANCED ACNE THERAPY Salicylic Acid SOAP TOPICAL 20160610 OTC MONOGRAPH FINAL part333D CVS Pharmacy, Inc. SALICYLIC ACID 2 g/100g N 20181231 69842-343_35446d0a-1f90-3a03-e054-00144ff88e88 69842-343 HUMAN OTC DRUG ADVANCED SEBORRHEIC DERMATITIS THERAPY Pyrithione Zinc SOAP TOPICAL 20160610 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc. PYRITHIONE ZINC 2 g/1000g N 20181231 69842-344_34f293ea-9b17-2f29-e054-00144ff88e88 69842-344 HUMAN OTC DRUG ADVANCED PSORIASIS THERAPY Coal Tar SOAP TOPICAL 20160610 OTC MONOGRAPH FINAL part358H CVS Pharmacy, Inc. COAL TAR 5 g/1000g N 20181231 69842-345_3543a40d-055b-158b-e054-00144ff8d46c 69842-345 HUMAN OTC DRUG ADVANCED ANTI-ITCH THERAPY Hydrocortisone SOAP TOPICAL 20160610 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc. HYDROCORTISONE ACETATE 1 g/100g N 20181231 69842-347_1fdc5bb8-1a0d-41a5-949d-0ad1667801fa 69842-347 HUMAN OTC DRUG Laxative Regular Strength Sennosides TABLET, SUGAR COATED ORAL 20031208 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy SENNOSIDES 15 mg/1 N 20181231 69842-348_ac846ac4-8d56-4eb6-b36a-dae36422e534 69842-348 HUMAN OTC DRUG CVS Pharmacy Toothache reliever Benzocaine GEL, DENTIFRICE DENTAL 20121001 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy BENZOCAINE; BENZALKONIUM CHLORIDE 20; .1 g/100g; g/100g N 20181231 69842-350_960e6c92-fb27-4eee-96d1-65beeb5d6587 69842-350 HUMAN OTC DRUG CVS Pharmacy Toothache and Gum Reliever Benzocaine GEL, DENTIFRICE DENTAL 20161101 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy BENZOCAINE; BENZALKONIUM CHLORIDE; MENTHOL 20; .1; .25 g/100g; g/100g; g/100g N 20181231 69842-351_8fc56c32-9060-4dd8-a22a-78695c176cbe 69842-351 HUMAN OTC DRUG CVS Pharmacy Toothache and Gum Reliever Benzocaine GEL, DENTIFRICE DENTAL 20161101 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy BENZOCAINE; BENZALKONIUM CHLORIDE; MENTHOL 20; .1; .5 g/100g; g/100g; g/100g N 20181231 69842-352_fbee707f-a5d0-4fe7-b094-c0523e0f1f60 69842-352 HUMAN OTC DRUG CVS Health Antibiotic Free Wound and Pain Relief Benzalkonium Chloride, Lidocaine Hydrochloride GEL TOPICAL 20170321 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE .13; 2 g/100mL; g/100mL N 20181231 69842-355_3cdfa932-6a21-2a82-e054-00144ff88e88 69842-355 HUMAN OTC DRUG REGULAR STRENGTH ANTACID MINT aluminum hydroxide, magnesium hydroxide, dimethicone LIQUID ORAL 20150601 OTC MONOGRAPH FINAL part331 CVS ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 69842-358_e54810b6-b5b6-4f61-8daa-38d2e4dc9f8b 69842-358 HUMAN OTC DRUG CVS Pharmacy Mouth Sore Benzocaine GEL, DENTIFRICE DENTAL 20121101 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy BENZOCAINE; BENZALKONIUM CHLORIDE; ZINC CHLORIDE 20; .02; .1 g/100g; g/100g; g/100g N 20181231 69842-360_4a527608-b4d5-57c0-e054-00144ff88e88 69842-360 HUMAN OTC DRUG Antacid Fruit Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20170105 OTC MONOGRAPH FINAL part331 CVS Pharmacy CALCIUM CARBONATE 750 mg/1 N 20181231 69842-361_4a6451d7-b3a0-37ac-e054-00144ff8d46c 69842-361 HUMAN OTC DRUG Antacid Fruit Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20170131 OTC MONOGRAPH FINAL part331 CVS Pharmacy CALCIUM CARBONATE 1000 mg/1 N 20181231 69842-362_4a656a9f-8f35-69b7-e054-00144ff8d46c 69842-362 HUMAN OTC DRUG Heartburn and gas fruit chews Calcium Carbonate TABLET, CHEWABLE ORAL 20170105 OTC MONOGRAPH FINAL part331 CVS Pharmacy CALCIUM CARBONATE; DIMETHICONE 750; 80 mg/1; mg/1 N 20181231 69842-363_4a67f0d0-788c-433b-e054-00144ff88e88 69842-363 HUMAN OTC DRUG Orange Antacid Soft Chew Calcium Carbonate TABLET, CHEWABLE ORAL 20170203 OTC MONOGRAPH FINAL part331 CVS Pharmacy CALCIUM CARBONATE 1177 mg/1 N 20181231 69842-364_4ab4c460-f43f-0b29-e054-00144ff8d46c 69842-364 HUMAN OTC DRUG Throat relief pops pectin LOZENGE ORAL 20170303 OTC MONOGRAPH NOT FINAL part356 CVS Pharmacy PECTIN 10 mg/1 N 20181231 69842-365_4b2d92e8-5647-1c21-e054-00144ff8d46c 69842-365 HUMAN OTC DRUG Wintermint Cough Drops Menthol LOZENGE ORAL 20170320 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 5.5 mg/1 N 20181231 69842-366_4b2e8ad7-88b7-4a0c-e054-00144ff8d46c 69842-366 HUMAN OTC DRUG Pumpkin Spice Cough Drops Menthol LOZENGE ORAL 20170320 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 2 mg/1 N 20181231 69842-367_61e03e5f-933d-773f-e053-2991aa0a3dfb 69842-367 HUMAN OTC DRUG Green Apple Cough Drops Menthol LOZENGE ORAL 20180103 OTC MONOGRAPH FINAL part341 CVS Pharmacy MENTHOL 2.6 mg/1 N 20191231 69842-368_61e4e83c-ee99-579d-e053-2991aa0ab099 69842-368 HUMAN OTC DRUG Cherry Antacid Soft Chews Calcium Carbonate TABLET, CHEWABLE ORAL 20180103 OTC MONOGRAPH FINAL part331 CVS Pharmacy CALCIUM CARBONATE 1177 mg/1 N 20191231 69842-371_499e4dc9-c79d-42f9-b47e-f1d1fcb20ce1 69842-371 HUMAN OTC DRUG Ultra Strength Antacid Tropical fruit Calcium antacid TABLET, CHEWABLE ORAL 20111209 OTC MONOGRAPH FINAL part331 CVS CALCIUM CARBONATE 1000 mg/1 N 20181231 69842-374_355237bf-d146-4a91-93b3-e68d89d2761c 69842-374 HUMAN OTC DRUG CVS Maximum Strength Cold and Hot Pain Relief Topical Analgesic Menthol, Unspecified Form LIQUID TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part348 CVS Health MENTHOL, UNSPECIFIED FORM 160 mg/mL N 20181231 69842-380_983cc655-cadd-4984-8d0a-f653d24be033 69842-380 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20110923 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy Inc MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 69842-388_6c9779d4-56b8-479b-ab0c-8f1bc84537e3 69842-388 HUMAN OTC DRUG CVS Eczema Relief Skin Protectant Oatmeal CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part347 CVS Health OATMEAL 10 mg/g N 20181231 69842-390_8e71c727-66ab-497b-ad8e-0230b43f9a1d 69842-390 HUMAN OTC DRUG Extra Strength Acetaminophen Acetaminophen TABLET, FILM COATED ORAL 20171109 OTC MONOGRAPH NOT FINAL part343 CVS PHARMACY, INC. ACETAMINOPHEN 500 mg/1 N 20181231 69842-391_71d1d56e-b34c-430b-a083-f305487ebfe6 69842-391 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20171109 ANDA ANDA079174 CVS PHARMACY, INC. IBUPROFEN 200 mg/1 N 20181231 69842-392_f89506a0-1322-4d0c-9392-6384eaaaf54b 69842-392 HUMAN OTC DRUG MAXIMUM STRENGTH Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20170925 OTC MONOGRAPH FINAL part338 CVS PHARMACY, INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 69842-393_1143cd81-0ebb-42fe-b2d4-324ded9fa21c 69842-393 HUMAN OTC DRUG Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20170925 OTC MONOGRAPH FINAL part338 CVS PHARMACY, INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69842-394_77bb30e0-35b0-40c8-a07e-98dfa91c1ce9 69842-394 HUMAN OTC DRUG Stomach Relief Bismuth subsalicylate TABLET, CHEWABLE ORAL 20171128 OTC MONOGRAPH FINAL part335 CVS PHARMACY, INC. BISMUTH SUBSALICYLATE 262 mg/1 N 20181231 69842-395_05742d9a-1a56-4982-b872-366f86091bbb 69842-395 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET, CHEWABLE ORAL 20171128 OTC MONOGRAPH FINAL part336 CVS PHARMACY, INC. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 69842-396_60ea7f8f-808e-403f-a349-474a3247b2c5 69842-396 HUMAN OTC DRUG Extra Strength Antacid Calcium Carbonate TABLET, CHEWABLE ORAL 20171213 OTC MONOGRAPH FINAL part331 CVS PHARMACY, INC. CALCIUM CARBONATE 750 mg/1 N 20181231 69842-400_603db11f-2dc1-49ea-e053-2a91aa0ad176 69842-400 HUMAN OTC DRUG CVS Itch Relief Pramoxine Hydrochloride and Zinc Acetate LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 CVS Pharmacy PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 10; 1 mg/mL; mg/mL N 20181231 69842-401_44b9b575-b999-60a8-e054-00144ff8d46c 69842-401 HUMAN OTC DRUG Wound and Burn Care Refill Pack Benzalkonium Chloride, Lidocaine HCL KIT TOPICAL 20161201 OTC MONOGRAPH FINAL part333A CVS N 20181231 69842-402_44aabf2a-0c1f-5f42-e054-00144ff8d46c 69842-402 HUMAN OTC DRUG CVS Cuts and Scrapes Refill Pack Benzalkonium Chloride, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate KIT TOPICAL 20161201 OTC MONOGRAPH FINAL part333A CVS N 20181231 69842-403_3ec07c56-74cf-436f-922c-fb830082e0f1 69842-403 HUMAN OTC DRUG Motion Sickness Less Drowsy Formula Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 CVS Pharmacy MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 69842-404_4664c90e-276f-0f6e-e054-00144ff88e88 69842-404 HUMAN OTC DRUG CVS Health Medication and Topical Refill Pouch aspirin, diphenhydramine hydrochloride, aspirin, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, acetaminophen KIT TOPICAL 20161228 OTC MONOGRAPH NOT FINAL part333A CVS N 20181231 69842-405_44aa37e6-e6a9-022a-e054-00144ff88e88 69842-405 HUMAN OTC DRUG CVS Pet Wound Care Prep-Pack Benzalkonium Chloride KIT TOPICAL 20161201 OTC MONOGRAPH FINAL part333A CVS N 20181231 69842-406_44a89313-dc89-570a-e054-00144ff8d46c 69842-406 HUMAN OTC DRUG CVS Blister Relief Refill Pack Benzalkonium Chloride KIT TOPICAL 20161201 OTC MONOGRAPH FINAL part333A CVS N 20181231 69842-407_4688ec6d-cf23-4e28-e054-00144ff8d46c 69842-407 HUMAN OTC DRUG CVS Health First Aid Outdoor Prep-Pack Ammonia KIT TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part348 CVS N 20181231 69842-411_6a97f765-3c22-422e-9cde-7d894145e222 69842-411 HUMAN OTC DRUG CVS Baby Nighttime Cold and Cough Matricaria Recutita, Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodide LIQUID ORAL 20170210 UNAPPROVED HOMEOPATHIC CVS Pharmacy MATRICARIA RECUTITA; EUPATORIUM PERFOLIATUM FLOWERING TOP; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; POTASSIUM IODIDE 6; 6; 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 69842-420_603dccb2-4208-68bc-e053-2a91aa0aaca8 69842-420 HUMAN OTC DRUG CVS Calamine Plus zinc oxide LOTION TOPICAL 20080101 OTC MONOGRAPH FINAL part347 CVS Pharmacy ZINC OXIDE; PRAMOXINE HYDROCHLORIDE 80; 10 mg/mL; mg/mL N 20181231 69842-421_4ac63cf7-f065-30a1-e054-00144ff88e88 69842-421 HUMAN OTC DRUG CVS Health Antacid and Pain Reliever Aspirin, Citric Acid, Sodium Bicarbonate TABLET, EFFERVESCENT ORAL 20061201 OTC MONOGRAPH FINAL part343 CVS Pharmacy ASPIRIN; SODIUM BICARBONATE; CITRIC ACID MONOHYDRATE 325; 1916; 1000 mg/1; mg/1; mg/1 N 20181231 69842-429_76c1af8f-8836-4bfe-9755-4c27964b6841 69842-429 HUMAN OTC DRUG Anticavity Fluoride Sodium Fluoride MOUTHWASH ORAL 20170130 OTC MONOGRAPH FINAL part355 CVS Pharmacy SODIUM FLUORIDE .1 mg/mL N 20181231 69842-439_d5b063d6-a6b1-4e42-a278-61f65e7fa376 69842-439 HUMAN OTC DRUG nighttime sleep aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20180115 OTC MONOGRAPH FINAL part338 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20191231 69842-449_b670b3d1-f5df-45b4-9e1f-530b598117c1 69842-449 HUMAN OTC DRUG Pain Relief childrens Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/1 N 20191231 69842-450_c822ee49-60e2-4f75-ab0f-1350a6140ec2 69842-450 HUMAN OTC DRUG Pain Relief childrens Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/1 N 20191231 69842-453_84a9f1d5-87f2-4041-adb4-0ad7d10e0051 69842-453 HUMAN OTC DRUG CVS Sodium Chloride, Sodium Bicarbonate KIT 20170424 UNAPPROVED DRUG OTHER CVS Pharmacy N 20181231 69842-454_5b547d5b-7671-410e-ae65-4f88ff5150be 69842-454 HUMAN OTC DRUG Artificial Tears Lubricant Eye Drops glycerin, propylene glycol SOLUTION/ DROPS OPHTHALMIC 20100901 OTC MONOGRAPH FINAL part349 CVS Pharmacy GLYCERIN; PROPYLENE GLYCOL 3; 10 mg/mL; mg/mL N 20181231 69842-456_3e4161c3-91b1-4c81-8e04-4b6d2722c5db 69842-456 HUMAN OTC DRUG CVS Oil Free Acne Facial Cleanser-Pink Grapefruit Acne Treatment Salicylic Acid LOTION TOPICAL 20140101 OTC MONOGRAPH FINAL part333D CVS Health SALICYLIC ACID 20 mg/mL N 20181231 69842-457_26852d94-5090-41c5-99ef-434b7383e684 69842-457 HUMAN OTC DRUG CVS Clarifying Acne Body Wash-Pink Grapefruit Acne Treatment Salicylic Acid LOTION TOPICAL 20140101 OTC MONOGRAPH FINAL part333D CVS Health SALICYLIC ACID 20 mg/mL N 20181231 69842-463_f262b10f-66af-40a9-a126-fb04fd9f52f8 69842-463 HUMAN OTC DRUG Clear Skin Salicylic acid LIQUID TOPICAL 20160916 OTC MONOGRAPH FINAL part333D CVS Pharmacy, Inc SALICYLIC ACID 3.57 mg/mL N 20181231 69842-480_44a8cdf2-f1fc-45ca-9efa-bd973160bfba 69842-480 HUMAN OTC DRUG CVS Health Blackhead Clearing Scrub Acne Medication Salicylic Acid CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part333D CVS Health SALICYLIC ACID 20 mg/g N 20181231 69842-486_e0779b5d-57a8-4203-9c00-46efdd33479b 69842-486 HUMAN OTC DRUG stool softener Docusate sodium CAPSULE, LIQUID FILLED ORAL 20160602 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 N 20181231 69842-490_60b6942c-2362-4c90-b04d-bd1ce2f54c28 69842-490 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Powder Miconazole Nitrate Talc Free POWDER TOPICAL 20170904 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 1.42 g/71g N 20181231 69842-501_1ec70787-86e4-45e3-becc-1e6359783fcc 69842-501 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Powder Miconazole Nitrate Talc Free POWDER TOPICAL 20170403 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 1.42 g/71g N 20181231 69842-502_a2913f10-1bef-42ce-b201-5a10231ad31a 69842-502 HUMAN OTC DRUG Miconazole Nitrate Jock Itch Spray AEROSOL, SPRAY TOPICAL 20170610 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 1.3 g/130g N 20181231 69842-503_fb1c7419-f9f8-4140-af0e-e62fcfd360e5 69842-503 HUMAN OTC DRUG Severe Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050804 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 69842-504_e59847d4-7588-4c53-bdcc-bc7acacebdcc 69842-504 HUMAN OTC DRUG Salicylic Acid Wart Remover Liquid Foot Care LIQUID TOPICAL 20170510 OTC MONOGRAPH FINAL part358B CVS Pharmacy SALICYLIC ACID .17 mg/15mL N 20181231 69842-507_992a8f95-475c-4e57-90cc-9839c8678427 69842-507 HUMAN OTC DRUG Lansoprazole Lansoprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 20171202 NDA NDA208025 CVS Pharmacy LANSOPRAZOLE 15 mg/1 N 20181231 69842-508_3557256e-e823-4bb3-85db-ca11abbea728 69842-508 HUMAN OTC DRUG Antacid Aluminum Hydroxide, Magnesium Hydroxide and Simethicone SUSPENSION ORAL 20110309 OTC MONOGRAPH FINAL part332 CVS ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 400; 400; 40 mg/5mL; mg/5mL; mg/5mL N 20181231 69842-511_de5a18ea-dd0b-40f8-826a-c44583ef11ba 69842-511 HUMAN OTC DRUG Miconazole Nitrate Athletes Foot Powder Spray Talc Free AEROSOL, POWDER TOPICAL 20170522 OTC MONOGRAPH FINAL part333C CVS Pharmacy MICONAZOLE NITRATE 2.6 g/130g N 20181231 69842-512_0a04d2d4-80b0-4b19-ae0b-19e26fb78999 69842-512 HUMAN OTC DRUG Tolnafate Tolnaftate Powder Spray AEROSOL, SPRAY TOPICAL 20170522 OTC MONOGRAPH FINAL part333C CVS Pharmacy TOLNAFTATE 1.3 g/130g N 20181231 69842-514_23e38940-c0fb-42a4-a0f2-e68e3b333cc7 69842-514 HUMAN OTC DRUG Salicylic Acid Corn Removers Salicylic Acid STRIP TOPICAL 20160101 OTC MONOGRAPH FINAL part358B CVS Pharmacy SALICYLIC ACID 40 mg/1 N 20181231 69842-525_092b6fbc-0479-4386-832f-e41bb43b55ac 69842-525 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET ORAL 20171231 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20191231 69842-527_6cf49a02-536a-47f0-8b83-8149744b7c91 69842-527 HUMAN OTC DRUG Stomach Relief Bismuth Subsalicylate LIQUID ORAL 20080908 OTC MONOGRAPH FINAL part335 CVS BISMUTH SUBSALICYLATE 262 mg/30mL N 20181231 69842-528_6e37d3f7-9589-427c-ae57-03b39833caf9 69842-528 HUMAN OTC DRUG Maximum strength Stomach Relief Bismuth Subsalicylate LIQUID ORAL 20080908 OTC MONOGRAPH FINAL part335 CVS BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 69842-530_4761bf4a-4a65-fe1f-e6d2-20db9630c55e 69842-530 HUMAN OTC DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20160229 ANDA ANDA208150 CVS Pharmacy FLUTICASONE PROPIONATE 50 ug/1 N 20181231 69842-531_e504d3de-1aa0-417d-b065-f7378f9001b1 69842-531 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET, FILM COATED ORAL 20051211 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/1 N 20181231 69842-535_5e079d68-d863-485e-b46f-d9a6c4fbface 69842-535 HUMAN OTC DRUG Childrens Allergy Loratadine SOLUTION ORAL 20161212 ANDA ANDA201865 CVS Pharmacy LORATADINE 5 mg/5mL N 20181231 69842-540_047304ed-07c9-4711-b694-5bf7c3809ca2 69842-540 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 CVS Pharmacy LORATADINE 5 mg/5mL N 20181231 69842-544_5ec1c10a-6a33-48f0-9e70-6c69fcc62c90 69842-544 HUMAN OTC DRUG 8HR Arthritis Pain Relief Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20000531 ANDA ANDA075077 CVS Pharmacy ACETAMINOPHEN 650 mg/1 N 20181231 69842-546_6cb1d08b-e544-4084-b9ed-1e0d99a709c8 69842-546 HUMAN OTC DRUG SEVERE COLD PLUS FLU DAYTIME NIGHTTIME Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride, and Doxylamine succinate KIT 20170714 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. N 20181231 69842-550_113f496e-09ae-4200-b2be-10e792f1eeec 69842-550 HUMAN OTC DRUG CVS Health Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part352 CVS OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g N 20181231 69842-550_abf31287-04a8-4795-ba7e-3957241f08d7 69842-550 HUMAN OTC DRUG CVS Health Moisture SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part352 CVS OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 40.7 mg/g; mg/g; mg/g N 20181231 69842-551_84a621fe-890e-4c88-9f26-f013c32b52b7 69842-551 HUMAN OTC DRUG CVS Health Cherry SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part352 CVS OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 44 mg/g; mg/g; mg/g N 20181231 69842-551_bfbf0241-51a6-4d9d-bee1-741d1645037d 69842-551 HUMAN OTC DRUG CVS Health Cherry SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part352 CVS OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 44 mg/g; mg/g; mg/g N 20181231 69842-552_6d58a18c-62ba-4cee-b3cc-51db746ba50e 69842-552 HUMAN OTC DRUG CVS Health Original SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part352 CVS OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 44 mg/g; mg/g; mg/g N 20181231 69842-552_e49680bd-bd61-40cf-abc8-51a1c8808726 69842-552 HUMAN OTC DRUG CVS Health Original SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum STICK TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part352 CVS OCTINOXATE; OXYBENZONE; PETROLATUM 7.5; 3.5; 44 mg/g; mg/g; mg/g N 20181231 69842-553_771c6e76-2a28-4b00-bfaf-ec1f6696c5b9 69842-553 HUMAN OTC DRUG CVS Camphor Phenol Gel Camphor, Phenol GEL TOPICAL 20150504 OTC MONOGRAPH NOT FINAL part348 CVS CAMPHOR (SYNTHETIC); PHENOL 10.8; 4.7 mg/g; mg/g N 20181231 69842-554_49c6ba74-c0db-430a-9f7d-dc0c758b8c88 69842-554 HUMAN OTC DRUG CVS Hand Sanitizer Alcohol GEL TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part333A CVS ALCOHOL 58.1 mg/g N 20181231 69842-555_11ff8e06-6e2d-463a-88cb-9c87ff859c8a 69842-555 HUMAN OTC DRUG CVS Hand Sanitizer Alcohol GEL TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part333A CVS ALCOHOL 58.1 mg/g N 20181231 69842-556_06defef6-dbf8-46ee-b829-df390b3135f3 69842-556 HUMAN OTC DRUG CVS Hand Sanitizer Alcohol GEL TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part333A CVS ALCOHOL 58.1 mg/g N 20181231 69842-557_d0081c50-c0d2-436a-ba83-5d1982ae64b7 69842-557 HUMAN OTC DRUG CVS Hand Sanitizer Alcohol SPRAY TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part333A CVS ALCOHOL 56 mg/g N 20181231 69842-558_4590c6ec-dadc-4278-bc44-c949396828a5 69842-558 HUMAN OTC DRUG CVS Hand Sanitizer Alcohol GEL TOPICAL 20170103 OTC MONOGRAPH NOT FINAL part333A CVS ALCOHOL 58.1 mg/g N 20181231 69842-559_051793ba-1ef0-41a1-bea1-0320100216a9 69842-559 HUMAN OTC DRUG CVS Hand Sanitizer Alcohol GEL TOPICAL 20170103 OTC MONOGRAPH NOT FINAL part333A CVS ALCOHOL 58.1 mg/g N 20181231 69842-560_0b0ad95b-7c90-417e-8d81-978433ee48b6 69842-560 HUMAN OTC DRUG CVS Hand Sanitizer Alcohol GEL TOPICAL 20170103 OTC MONOGRAPH NOT FINAL part333A CVS ALCOHOL 58.1 mg/g N 20181231 69842-561_3f11cb12-fcf2-431a-e054-00144ff88e88 69842-561 HUMAN OTC DRUG germfree 24 Hand Sanitizer benzalkonium chloride SOLUTION TOPICAL 20161017 OTC MONOGRAPH NOT FINAL part333E CVS BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 69842-571_e6e21571-12d2-4241-a64e-8b13508c9cad 69842-571 HUMAN OTC DRUG CVS Health Acne Control Cleanser Acne Medication Benzoyl Peroxide LOTION TOPICAL 20140101 OTC MONOGRAPH FINAL part333D CVS Health BENZOYL PEROXIDE 100 mg/g N 20181231 69842-578_8316fc95-5e17-4e70-b4c5-dd641ea27ac4 69842-578 HUMAN OTC DRUG Stool Softener Laxative DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170831 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 N 20181231 69842-579_d53efdfd-35d9-465b-90d4-2863994e8c50 69842-579 HUMAN OTC DRUG Stool Softener Laxative DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170831 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 N 20181231 69842-580_387867e7-c844-4bb7-8230-96b27804e38c 69842-580 HUMAN OTC DRUG CVS Oil Free Acne Cleanser Acne Treatment Salicylic Acid CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part333D CVS Health SALICYLIC ACID 20 mg/mL N 20181231 69842-581_b4cb70a0-d000-40a1-aeda-8f7321a95508 69842-581 HUMAN OTC DRUG Anticavity Sodium fluoride MOUTHWASH ORAL 20170124 OTC MONOGRAPH FINAL part355 CVS Pharmacy SODIUM FLUORIDE .2 mg/mL N 20181231 69842-582_e8afa076-71f5-4cdf-8d32-e5bf872c615b 69842-582 HUMAN OTC DRUG Daily Acne CVS Salicylic Acid 2.00% LOTION TOPICAL 20170117 OTC MONOGRAPH FINAL part333D CVS SALICYLIC ACID 2 g/100mL N 20181231 69842-583_bb681350-8367-4fe3-8617-0ec1d8f53a97 69842-583 HUMAN OTC DRUG CVS Clarifying Body Wash Acne Treatment Salicylic Acid LOTION TOPICAL 20140101 OTC MONOGRAPH FINAL part333D CVS Health SALICYLIC ACID 20 mg/mL N 20181231 69842-584_61b01837-50bf-41af-8750-98410ff5757a 69842-584 HUMAN OTC DRUG CVS Foaming Hand Sanitizer Antibacterial Benzalkonium Chloride LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333E CVS Health BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 69842-596_58a95702-364a-4c19-afd8-51973b79ea85 69842-596 HUMAN OTC DRUG SALICYLIC ACID WART REMOVER Salicylic Acid STRIP TOPICAL 20160101 OTC MONOGRAPH FINAL part358H CVS Pharmacy SALICYLIC ACID 40 mg/1 N 20181231 69842-599_b64b3bfb-ed0a-4f28-83c7-163b0b63fe20 69842-599 HUMAN OTC DRUG hair regrowth treatment Minoxidil AEROSOL, FOAM TOPICAL 20170307 ANDA ANDA091344 CVS Pharmacy MINOXIDIL 50 mg/g N 20181231 69842-602_503486dd-b930-4845-a29f-968d4574cb82 69842-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL 19980715 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 69842-603_7097706d-8a02-4d5e-b67e-2a59fe9f6e8b 69842-603 HUMAN OTC DRUG CVS Oil Free Acne Foaming Scrub-Pink Grapefruit Acne Medication Salicylic Acid LOTION TOPICAL 20140101 OTC MONOGRAPH FINAL part333D CVS Health SALICYLIC ACID 20 mg/mL N 20181231 69842-604_8ed8a66f-54c7-46f1-be27-9330d595e836 69842-604 HUMAN OTC DRUG CVS Baby Diaper Rash and Skin Protectant Skin Protectant Lanolin and Petrolatum OINTMENT TOPICAL 20140101 OTC MONOGRAPH FINAL part347 CVS Health LANOLIN; PETROLATUM 155; 535 mg/g; mg/g N 20181231 69842-610_45d5e475-0982-038e-e054-00144ff88e88 69842-610 HUMAN OTC DRUG CVS Triple Antibiotic Bacitracin, Neomycin, Polymyxin B OINTMENT TOPICAL 20081101 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 69842-611_7be20e6c-f451-45cb-b542-0f35272b0245 69842-611 HUMAN OTC DRUG CVS Astringent Eye Tetrahydrozoline HCl, Zinc sulfate SOLUTION/ DROPS OPHTHALMIC 20071101 OTC MONOGRAPH FINAL part349 CVS Pharmacy, Inc. TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE 50; 250 mg/100mL; mg/100mL N 20181231 69842-613_4d46007b-b845-4ceb-b830-21262e219369 69842-613 HUMAN OTC DRUG Tussin 12 HR dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20170622 ANDA ANDA091135 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 69842-615_45d91c02-243a-6ebe-e054-00144ff88e88 69842-615 HUMAN OTC DRUG CVS Pain Relieving First Aid Antiseptic Lidocaine Hydrochloride, Benzalkonium Chloride SPRAY TOPICAL 20140415 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE .025; .0013 g/g; g/g N 20181231 69842-618_cecb753d-400f-4b7f-aee7-dc5b551bcc01 69842-618 HUMAN OTC DRUG CVS Pinworm Treatment PYRANTEL PAMOATE SUSPENSION ORAL 20161215 OTC MONOGRAPH FINAL part357B CVS PHARMACY INC PYRANTEL PAMOATE 144 mg/mL N 20181231 69842-628_53fc0cf8-5d9a-41f9-e054-00144ff8d46c 69842-628 HUMAN OTC DRUG EXTRA STRENGTH HEARTBURN RELIEF aluminum hydroxide and magnesium carbonate SUSPENSION ORAL 20170201 OTC MONOGRAPH FINAL part331 CVS PHARMACY,INC. ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 254; 237.5 mg/5mL; mg/5mL N 20181231 69842-637_d4d34404-3c2a-46a2-b77d-cd1a68f508bf 69842-637 HUMAN OTC DRUG CVS Health Maximum Strength Acne Treatment Acne Medication Benzoyl Peroxide GEL TOPICAL 20140101 OTC MONOGRAPH FINAL part333D CVS Health BENZOYL PEROXIDE 100 mg/mL N 20181231 69842-638_45d94180-4436-7298-e054-00144ff88e88 69842-638 HUMAN OTC DRUG CVS Pharmacy Sensitive Medicated Cream Benzocaine, Benzalkonium Chloride CREAM TOPICAL 20050501 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy BENZOCAINE; BENZALKONIUM CHLORIDE .05; .0013 g/g; g/g N 20181231 69842-650_cdb92ef7-8ff7-4bc9-9d83-b514a613e1ea 69842-650 HUMAN OTC DRUG CVS Health Antibiotic Free Wound Benzalkonium Chloride GEL TOPICAL 20170321 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 69842-653_c310da4f-9139-42bf-b740-521d2c838f0b 69842-653 HUMAN OTC DRUG Flu, Cough and Sore Throat Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl LIQUID ORAL 20160930 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/30mL; mg/30mL; mg/30mL N 20181231 69842-658_79e45f5e-4af4-4946-9155-af55a4eb3ac5 69842-658 HUMAN OTC DRUG Sleep-Aid Nighttime Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20180115 OTC MONOGRAPH FINAL part338 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69842-669_ea872217-d1d0-4da3-b59b-3f02ce537c29 69842-669 HUMAN OTC DRUG Antibiotic, Pain and Scar Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl OINTMENT TOPICAL 20170220 OTC MONOGRAPH FINAL part333B CVS Pharmacy BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 69842-672_6e93bb77-510d-4e38-aeec-4f83746861e5 69842-672 HUMAN OTC DRUG Sleep-Aid Nighttime diphenhydramine HCl TABLET, FILM COATED ORAL 20150724 OTC MONOGRAPH FINAL part338 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69842-678_5e710573-bc51-41fc-8406-b607e4153bef 69842-678 HUMAN OTC DRUG Pain Relief Regular Strength Acetaminophen TABLET ORAL 20150724 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 325 mg/1 N 20181231 69842-682_eaac4a49-9ec7-4508-af68-fa6596464824 69842-682 HUMAN OTC DRUG Sleep- Aid Nighttime Diphenhydramine HCl CAPSULE ORAL 20160731 OTC MONOGRAPH FINAL part338 CVS Pharmacy DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69842-684_5c1d0302-37fc-4eff-85ed-741b830032ae 69842-684 HUMAN OTC DRUG Stool Softener Laxative DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170831 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy DOCUSATE SODIUM 100 mg/1 N 20181231 69842-686_6cdb55fd-eb61-45a6-8b6c-87407f238800 69842-686 HUMAN OTC DRUG LORATADINE LORATADINE CAPSULE, LIQUID FILLED ORAL 20170131 ANDA ANDA206214 CVS HEALTH CORP LORATADINE 10 mg/1 N 20181231 69842-689_ce1445ca-2549-4348-8288-0f1c102957aa 69842-689 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr TABLET, FILM COATED ORAL 20170331 OTC MONOGRAPH FINAL part341 CVS Pharmacy CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 69842-692_c2d32458-fd71-4450-b097-e15b3d0948ff 69842-692 HUMAN OTC DRUG Cold and Flu HBP Acetaminophen, Chlorpheniramine maleate TABLET, FILM COATED ORAL 20170716 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 325; 2 mg/1; mg/1 N 20181231 69842-694_09494128-cf8a-4d18-b6c0-dd4a974b7180 69842-694 HUMAN OTC DRUG Severe Cold, Cold and Flu Maximum Strength, Daytime, Nightime acetaminophen, dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl KIT 20170701 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 69842-700_d6eab1d6-be4b-47fc-be21-e8464e7fb748 69842-700 HUMAN OTC DRUG MULTI SYMPTOM SEVERE COLD Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20160914 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 25; 10 mg/1; mg/1; mg/1 N 20181231 69842-701_c92677b3-941a-4797-b2ce-eae2db83477d 69842-701 HUMAN OTC DRUG ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20171222 ANDA ANDA203599 CVS Pharmacy IBUPROFEN 200 mg/1 N 20191231 69842-704_ce6fd7f6-7be1-405b-aafa-563e3cb256ae 69842-704 HUMAN OTC DRUG Allergy Relief Fexofenadine HCl TABLET, COATED ORAL 20171031 ANDA ANDA079112 CVS Pharmacy FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 69842-712_45d99cac-2d16-0806-e054-00144ff88e88 69842-712 HUMAN OTC DRUG CVS Sore Muscle Rub Vanishing Scent Menthol CREAM TOPICAL 20080601 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy MENTHOL .025 g/g N 20181231 69842-716_2c9624ef-c015-4ae6-b341-8968a375832d 69842-716 HUMAN OTC DRUG Extra Strength Smooth Antacid Calcium carbonate TABLET, CHEWABLE ORAL 20151103 OTC MONOGRAPH FINAL part331 CVS CALCIUM CARBONATE 750 mg/1 N 20181231 69842-718_45d9c7f6-bb6a-11cd-e054-00144ff88e88 69842-718 HUMAN OTC DRUG CVS Pharmacy Maximum Strength Antifungal Liquid with Aloe and Vitamin E Undecylenic acid LIQUID TOPICAL 20100501 OTC MONOGRAPH FINAL part333C CVS Pharmacy UNDECYLENIC ACID .25 g/L N 20181231 69842-727_b751a4d2-6029-423c-9725-1b940a6fc8d8 69842-727 HUMAN OTC DRUG Daytime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20170721 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 69842-733_e8fd21a5-d690-474e-946d-18c5fad3fa97 69842-733 HUMAN OTC DRUG Daytime Nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT 20160623 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 69842-749_603e0f64-0983-b731-e053-2a91aa0abf1c 69842-749 HUMAN OTC DRUG CVS Merthiolate Benzalkonium Chloride LIQUID TOPICAL 20080101 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 69842-751_4fb2636e-15da-4d6f-8d35-68cff348821a 69842-751 HUMAN OTC DRUG Tussin 12 HR dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20170622 ANDA ANDA091135 CVS Pharmacy DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 69842-753_03f521f4-d35f-4f66-b3ad-7e58a244eb93 69842-753 HUMAN OTC DRUG CVS Health Nighttime Sleep Aid DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20171011 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 69842-768_60dd2041-3f91-0f0e-e053-2991aa0ae41d 69842-768 HUMAN OTC DRUG Effervescent Cold Relief Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20151029 OTC MONOGRAPH FINAL part341 CVS Pharmacy ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE 325; 7.8; 2 mg/1; mg/1; mg/1 N 20181231 69842-775_c7c5f730-327c-4b23-9e3d-cc0413f6be36 69842-775 HUMAN OTC DRUG Salicylic Acid Astringent LIQUID TOPICAL 20090605 OTC MONOGRAPH FINAL part333D CVS Pharmacy, Inc SALICYLIC ACID 5 mg/mL N 20181231 69842-777_b047e108-0165-47db-a892-823dfe732d58 69842-777 HUMAN OTC DRUG Arthritis Hand CVS Trolamine Salicylate CREAM TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part348 CVS TROLAMINE SALICYLATE 10 g/100g N 20181231 69842-778_dbdec53d-0c97-46a7-83c7-4a78646b4ad9 69842-778 HUMAN OTC DRUG Sunscreen SPF 50 Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0% SPRAY TOPICAL 20160315 OTC MONOGRAPH NOT FINAL part352 CVS AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 10 1/100mL; 1/100mL; 1/100mL; 1/100mL N 20181231 69842-784_d5d8527d-d26d-45c5-a07b-9577518d98c2 69842-784 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol SPRAY TOPICAL 20170222 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy, Inc ALCOHOL .63 mL/mL N 20181231 69842-800_0c16a940-4702-4371-842a-020c7271cce0 69842-800 HUMAN OTC DRUG Nighttime Severe Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl SOLUTION ORAL 20160623 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 69842-801_4663a201-42a7-692b-e054-00144ff88e88 69842-801 HUMAN OTC DRUG Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen LOTION TOPICAL 20170118 OTC MONOGRAPH FINAL part352 CVS Pharmacy, Inc OCTINOXATE; TITANIUM DIOXIDE 7.5; 10 g/100g; g/100g N 20181231 69842-820_e6578d5d-867d-49bc-b986-c6d13dfde41b 69842-820 HUMAN OTC DRUG Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI, Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI KIT 20170228 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 69842-835_cdca16a9-3c61-4715-911b-9dfaef5979a3 69842-835 HUMAN OTC DRUG CVS Ibuprofen Sodium Ibuprofen TABLET, FILM COATED ORAL 20170110 ANDA ANDA206581 CVS Pharmacy IBUPROFEN SODIUM 256 mg/1 N 20181231 69842-839_63789548-fe35-435f-82a9-1b4aa2ecc974 69842-839 HUMAN OTC DRUG Advanced 3 in 1 Exfoliating Cleanser Benzoyl Peroxide 5.0% CREAM TOPICAL 20170615 OTC MONOGRAPH FINAL part333D CVS BENZOYL PEROXIDE 5 g/100mL N 20181231 69842-840_149bfd2d-6d8a-4c40-a919-186997efe216 69842-840 HUMAN OTC DRUG Sunburn Pain Reliever CVS Lidocaine Hydrochloride 0.5% GEL TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part348 CVS LIDOCAINE HYDROCHLORIDE .5 g/100g N 20181231 69842-841_01daf019-101f-4b8b-8f18-b7162e6f2043 69842-841 HUMAN OTC DRUG Sheer Sunscreen SPF 30 CVS Health Avobenzone 2% Homosalate 5.5% Octisalate 4.5% Octocrylene 4% LOTION TOPICAL 20170315 OTC MONOGRAPH NOT FINAL part352 CVS AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 5.5; 4.5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69842-842_ee0481a3-7cd0-488d-88c5-1654fbad4869 69842-842 HUMAN OTC DRUG Itch Relief Medicated Pads CVS Pramoxine HCl, Zinc Acetate LIQUID TOPICAL 20170315 OTC MONOGRAPH FINAL part347 CVS PRAMOXINE HYDROCHLORIDE; ZINC ACETATE 1; .1 g/100g; g/100g N 20181231 69842-843_9d2d24fa-144b-46fa-bb73-260958b5bf9f 69842-843 HUMAN OTC DRUG CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL PHENYLEPHRINE HYDROCHLORIDE and WITCH HAZEL GEL RECTAL 20040101 OTC MONOGRAPH FINAL part346 CVS PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 2.5; 500 mg/g; mg/g N 20181231 69842-845_5f89b9f3-7a29-3109-e053-2991aa0a3a2f 69842-845 HUMAN OTC DRUG ITCH REL SPR CVS Diphenhydramine HCl 2% Zinc Acetate 0.1% SPRAY TOPICAL 20140214 OTC MONOGRAPH NOT FINAL part348 CVS DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE ANHYDROUS 2; .1 g/100mL; g/100mL N 20181231 69842-849_5f9c6db8-ee69-7de3-e053-2a91aa0ad1d6 69842-849 HUMAN OTC DRUG Cracked Heel Balm CVS Dimethicone 1.00% STICK TOPICAL 20141112 OTC MONOGRAPH FINAL part347 CVS DIMETHICONE 1 g/100g N 20181231 69842-850_5fc5791f-e28c-7de7-e053-2991aa0a2a41 69842-850 HUMAN OTC DRUG Daily Face Wash CVS Salicylic Acid CREAM TOPICAL 20141222 OTC MONOGRAPH FINAL part333D CVS SALICYLIC ACID 2 g/100mL N 20181231 69842-854_22c7ee82-2641-48d6-868c-a605b5a43965 69842-854 HUMAN OTC DRUG Antiseptic Medicated CVS Benzalkonium Chloride 0.10% Benzocaine 20.00% LIQUID TOPICAL 20170315 OTC MONOGRAPH NOT FINAL part348 CVS BENZALKONIUM CHLORIDE; BENZOCAINE .1; 20 g/100g; g/100g N 20181231 69842-855_eb27a460-00ce-4998-afc0-84e3c4949800 69842-855 HUMAN OTC DRUG Bite and Sting Medicated Relief Pads CVS Benzocaine - 5.00% LIQUID TOPICAL 20170415 OTC MONOGRAPH NOT FINAL part348 CVS BENZOCAINE 5 g/100g N 20181231 69842-865_5e5b50a1-9785-40ab-a406-2e4c12c0815b 69842-865 HUMAN OTC DRUG Body Menthol POWDER TOPICAL 20160708 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy, Inc MENTHOL 10 mg/g N 20181231 69842-866_3f2cf141-bc0c-4049-abbb-eed9850476c5 69842-866 HUMAN OTC DRUG CVS Clotrimazole Maximum Strength CLOTRIMAZOLE SOLUTION TOPICAL 20020201 OTC MONOGRAPH FINAL part333C CVS Pharmacy CLOTRIMAZOLE 10 mg/mL N 20181231 69842-867_d45ab13d-14fe-13f2-c0a5-76536ac24526 69842-867 HUMAN OTC DRUG Allergy Relief Cetirizine Hydrochloride Tablets TABLET, FILM COATED ORAL 20111201 ANDA ANDA078343 CVS Health Corp. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 69842-869_7cd094d1-2de0-6450-8245-5ee3f2de1338 69842-869 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, COATED ORAL 20100501 ANDA ANDA078192 CVS HEALTH CORP RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 69842-871_e0354733-3f66-e566-b929-27928563837d 69842-871 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET ORAL 20090701 ANDA ANDA075294 CVS HEALTH CORP RANITIDINE HYDROCHLORIDE 75 mg/1 N 20181231 69842-872_c6d1b9dd-1728-4006-bafb-3a4364c6dc72 69842-872 HUMAN OTC DRUG CVS Pharmacy Pro Defense Fluoride PASTE, DENTIFRICE DENTAL 20170601 OTC MONOGRAPH FINAL part355 CVS Pharmacy STANNOUS FLUORIDE .454 g/100g N 20181231 69842-875_5c8c2735-d9fc-80e2-e053-2a91aa0a134f 69842-875 HUMAN OTC DRUG Effervescent Orange Cold Relief Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate TABLET, EFFERVESCENT ORAL 20170310 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. PHENYLEPHRINE BITARTRATE; ASPIRIN; CHLORPHENIRAMINE MALEATE 7.8; 325; 2 mg/1; mg/1; mg/1 N 20181231 69842-882_c0f33792-df66-4212-94ab-87634ba14fb5 69842-882 HUMAN OTC DRUG Sinus Relief Daytime, Nighttime, Maximum Strength Acetaminophen, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl KIT 20170701 OTC MONOGRAPH FINAL part341 CVS Pharmacy N 20181231 69842-885_bd23a737-578a-4156-83a5-b91b418a2c46 69842-885 HUMAN OTC DRUG DAYTIME SEVERE COLD and COUGH NIGHTTIME SEVERE COLD and COUGH Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl KIT 20151209 OTC MONOGRAPH FINAL part341 CVS Pharmacy,Inc. N 20181231 69842-889_0b76c87a-44af-4e7e-a6eb-3e6b75897ce5 69842-889 HUMAN OTC DRUG Nighttime Sleep Aid Softgels Diphenhydramine Hydrochloride CAPSULE, GELATIN COATED ORAL 20151117 OTC MONOGRAPH FINAL part338 CVS Pharmacy,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69842-889_1260e27f-0337-4bb9-81db-3b2bdcc369e8 69842-889 HUMAN OTC DRUG Nighttime Sleep Aid Softgels Diphenhydramine Hydrochloride CAPSULE, GELATIN COATED ORAL 20150924 OTC MONOGRAPH FINAL part338 CVS Pharmacy,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69842-889_610c1c4d-ce25-4aff-aa75-aae7662dcc51 69842-889 HUMAN OTC DRUG Nighttime Sleep Aid Softgels Diphenhydramine Hydrochloride CAPSULE, GELATIN COATED ORAL 20150714 OTC MONOGRAPH FINAL part338 CVS Pharmacy,Inc. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 69842-898_6f1d75c1-3c0d-41c2-a625-1ee1bf642c32 69842-898 HUMAN OTC DRUG esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170925 ANDA ANDA207193 CVS Pharmacy ESOMEPRAZOLE 20 mg/1 N 20181231 69842-900_cf2e16be-0126-412e-9ddd-013f97a7a742 69842-900 HUMAN OTC DRUG Fluticasone Propionate Nasal Fluticasone propionate SPRAY, METERED NASAL 20161217 ANDA ANDA207957 CVS Pharmacy FLUTICASONE PROPIONATE 50 ug/1 N 20181231 69842-902_f722e7ce-6cca-4850-a230-7510c7ca7754 69842-902 HUMAN OTC DRUG CVS Health Extra Strength Sugar Free Antacid Antacid TABLET, CHEWABLE ORAL 20170207 OTC MONOGRAPH FINAL part331 CVS Pharmacy,Inc. CALCIUM CARBONATE 750 mg/1 N 20181231 69842-907_0095c36b-4ed3-4b2f-85e2-f08369d9a6a4 69842-907 HUMAN OTC DRUG nighttime cold and flu relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20170622 OTC MONOGRAPH FINAL part341 CVS Pharmacy ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 69842-910_d66fae74-eb75-413b-ae38-c8937ed14f3d 69842-910 HUMAN OTC DRUG Charcoal Blackhead Clearing Scrub Salicylic Acid CREAM TOPICAL 20160301 OTC MONOGRAPH FINAL part333D CVS Pharmacy, Inc. SALICYLIC ACID 20.6 mg/mL N 20181231 69842-911_d353dad3-1e70-4fe1-8fc2-ccfb4f9fe6a1 69842-911 HUMAN OTC DRUG ALLERGY RELIEF Cetirizine Hydrochloride CAPSULE ORAL 20180206 NDA NDA022429 CVS Pharmacy CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20191231 69842-925_53ac017a-eccc-3b24-e054-00144ff88e88 69842-925 HUMAN OTC DRUG CVS Health Antiseptic Wound Wash Lidocaine Hydrochloride, Benzalkonium Chloride RINSE TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part348 CVS Pharmacy LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE .025; .0013 g/g; g/g N 20181231 69842-936_647b193f-f663-27ff-e053-2a91aa0ac610 69842-936 HUMAN OTC DRUG CVS Health Povidone Iodine Swabstick Povidone Iodine SWAB TOPICAL 20180205 OTC MONOGRAPH NOT FINAL part333A CVS Pharmacy Inc POVIDONE-IODINE 10 mg/mL N 20191231 69842-945_c93d8c93-7ae4-4ff4-986f-056279cbce89 69842-945 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen LIQUID ORAL 20180115 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 500 mg/15mL N 20181231 69842-950_02e48e12-a4e5-4d00-802f-96225b2c80cb 69842-950 HUMAN OTC DRUG Miconazole 3 Miconazole nitrate KIT TOPICAL; VAGINAL 19960416 NDA NDA020670 CVS Pharmacy N 20181231 69842-955_12590adf-18e1-450c-95d3-87040f0d1a64 69842-955 HUMAN OTC DRUG Medicated Cornstarch Baby Powder Active Corn Starch, Zinc Oxide, Kaolin POWDER TOPICAL 20170110 OTC MONOGRAPH FINAL part347 CVS STARCH, CORN; ZINC OXIDE; KAOLIN 89.27; 16.95; 4.52 g/113g; g/113g; g/113g N 20181231 69842-959_fac408f0-ebb6-4c72-88ee-2ba85867859c 69842-959 HUMAN OTC DRUG childrens pain and fever Acetaminophen SUSPENSION ORAL 20170627 OTC MONOGRAPH NOT FINAL part343 CVS Pharmacy ACETAMINOPHEN 160 mg/5mL N 20181231 69842-960_60ab2769-4e69-43da-8244-501e35bda6cf 69842-960 HUMAN OTC DRUG Fresh Scent Protective Powder Talc and Zinc Oxide POWDER TOPICAL 20170111 OTC MONOGRAPH NOT FINAL part347 CVS TALC; ZINC OXIDE 115; 21.3 g/142g; g/142g N 20181231 69842-970_55a31f73-da0e-4b77-e054-00144ff88e88 69842-970 HUMAN OTC DRUG UltraCare Alcohol Free Sodium Fluoride MOUTHWASH ORAL 20151119 20180831 OTC MONOGRAPH FINAL part355 CVS Pharmacy SODIUM FLUORIDE .001 g/10mL N 20181231 69842-971_55b37125-b90e-0092-e054-00144ff88e88 69842-971 HUMAN OTC DRUG CVS Complete Health Premium Sodium Fluoride MOUTHWASH ORAL 20151218 20180420 OTC MONOGRAPH FINAL part355 CVS Pharmacy SODIUM FLUORIDE .001 g/10mL N 20181231 69842-975_c7c3752a-2bea-4a79-9695-046c43fc9276 69842-975 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium CAPSULE, LIQUID FILLED ORAL 20180206 NDA NDA021920 CVS Pharmacy NAPROXEN SODIUM 220 mg/1 N 20191231 69842-978_d78039a9-98ff-4c45-8da6-ac217bc033fa 69842-978 HUMAN OTC DRUG Castor Oil Castor Oil LIQUID ORAL 20090520 OTC MONOGRAPH NOT FINAL part334 CVS Pharmacy CASTOR OIL 1 mg/mL N 20181231 69842-985_53abfe0f-8e57-05b7-e054-00144ff8d46c 69842-985 HUMAN OTC DRUG HemAway Lidocane and Phenylephrine HCL CREAM TOPICAL 20101213 OTC MONOGRAPH FINAL part346 CVS Pharmacy, Inc LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE 50; 2.5 mg/g; mg/g N 20181231 69842-986_974d7545-ca2b-4f94-a9ca-cde7d891dcbf 69842-986 HUMAN OTC DRUG Athletes Foot Butenafine Hydrochloride CREAM TOPICAL 20171117 ANDA ANDA205181 CVS Pharmacy BUTENAFINE HYDROCHLORIDE 10 mg/g N 20181231 69842-987_dfe0df34-0d26-4ca4-a73f-c01383424a52 69842-987 HUMAN OTC DRUG Severe Congestion and Cough, Cold and Flu Daytime, Nighttime Acetaminophen, Dextromethorphan HBr, Diphenhydramine HCl, Guaifenesin, Phenylephrine HCl KIT 20170701 OTC MONOGRAPH NOT FINAL part341 CVS Pharmacy N 20181231 69842-995_efca92d7-ff95-4238-8ec6-66d68c37d3e4 69842-995 HUMAN OTC DRUG CVS HEALTH Chest Congestion Relief Guaifenesin TABLET ORAL 20120801 OTC MONOGRAPH FINAL part341 CVS PHARMACY INC GUAIFENESIN 400 mg/1 N 20181231 69842-996_262c8fe2-3f3f-4cde-96fb-7c464d8b9dc2 69842-996 HUMAN OTC DRUG CVS Chest Congestion Relief DM Dextromethorphan Hydrobromide / Guaifenesin TABLET ORAL 20091207 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 69842-997_9c9470a8-3bee-4892-a825-fc4e0b00695c 69842-997 HUMAN OTC DRUG CVS Health Chest Congestion Relief PE Guaifenesin/phenylephrine TABLET ORAL 20060605 OTC MONOGRAPH FINAL part341 CVS Pharmacy, Inc. GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 69846-000_9c2026f1-793c-4f80-a72b-717692d5811a 69846-000 HUMAN OTC DRUG Equalactin Laxative Calcium polycarbophil TABLET ORAL 19861121 OTC MONOGRAPH NOT FINAL part334 NUMARK BRANDS, INC CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 69846-020_e698255f-1cdd-e4b6-a76b-c90e77607159 69846-020 HUMAN OTC DRUG 5 Day Aluminum zirconium tetrachlorohydrex glycine LIQUID TOPICAL 19370410 OTC MONOGRAPH FINAL part350 NUMARK BRANDS, INC ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 20 g/100mL N 20181231 69846-100_b63db6fd-ed7e-e5a5-43f8-7a2da56586ca 69846-100 HUMAN OTC DRUG Agoral Sennocides LIQUID ORAL 19420505 OTC MONOGRAPH NOT FINAL part334 NUMARK BRANDS, INC SENNOSIDES A AND B 8.3 mg/5mL N 20181231 69846-110_582b4be0-b918-634c-eee0-10a32483b7c9 69846-110 HUMAN OTC DRUG 5 Day Aluminum chlorohydrate LIQUID TOPICAL 19370410 OTC MONOGRAPH FINAL part350 NUMARK BRANDS, INC ALUMINUM CHLOROHYDRATE .25 g/1 N 20181231 69846-140_c650cafd-602d-24a1-3e05-82a84f084a25 69846-140 HUMAN OTC DRUG Alophen Bisacodyl TABLET, COATED ORAL 19070415 OTC MONOGRAPH NOT FINAL part334 NUMARK BRANDS, INC BISACODYL 5 mg/1 N 20181231 69846-860_c65b5e0a-80f6-d25b-95f4-e27a60969bd4 69846-860 HUMAN OTC DRUG S.T.37 Hexylresorcinol SOLUTION ORAL; TOPICAL 19291120 UNAPPROVED DRUG OTHER NUMARK BRANDS, INC HEXYLRESORCINOL 1.1 mg/mL N 20181231 69846-911_84532891-5651-639b-c228-00c94d607bdc 69846-911 HUMAN OTC DRUG Adult Acnomel Resorcinol, Sulfur CREAM TOPICAL 19461008 OTC MONOGRAPH NOT FINAL part348 NUMARK BRANDS, INC RESORCINOL; SULFUR 20; 80 mg/g; mg/g N 20181231 69847-001_58896bf6-3e94-448f-8b04-11c9e593a995 69847-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20170401 NDA NDA205865 Respiratory Care Partners, Inc OXYGEN 99 L/100L N 20191231 69851-101_791a8ab3-28c4-43a9-9912-e76b2750da53 69851-101 HUMAN OTC DRUG THERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON MENTHOL GEL TOPICAL 20150515 OTC MONOGRAPH NOT FINAL part348 APEX-CAREX HEATHCARE PRODUCTS MENTHOL 3.9 g/100mL E 20171231 69851-102_2f6bb626-09d0-4190-8d8b-0b15f2161196 69851-102 HUMAN OTC DRUG THERAPEUTIC ICY COLD COOLING PAIN RELIEF MENTHOL SPRAY TOPICAL 20150515 OTC MONOGRAPH NOT FINAL part348 APEX-CAREX HEATHCARE PRODUCTS MENTHOL 6 g/100mL E 20171231 69851-103_2d7c5542-aa01-41a1-9bd6-484d1ee6aa87 69851-103 HUMAN OTC DRUG THERAPEUTIC ICY COLD COOLING PAIN RELIEF MENTHOL GEL TOPICAL 20150515 OTC MONOGRAPH NOT FINAL part348 APEX-CAREX HEATHCARE PRODUCTS MENTHOL 3.9 g/100mL E 20171231 69853-0201_5e825dd0-d74c-4826-9235-a3bf5d07db42 69853-0201 HUMAN PRESCRIPTION DRUG BEVYXXA betrixaban CAPSULE, GELATIN COATED ORAL 20170707 NDA NDA208383 Portola Pharmaceuticals, Inc. BETRIXABAN 80 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] N 20181231 69853-0202_5e825dd0-d74c-4826-9235-a3bf5d07db42 69853-0202 HUMAN PRESCRIPTION DRUG BEVYXXA betrixaban CAPSULE, GELATIN COATED ORAL 20170707 NDA NDA208383 Portola Pharmaceuticals, Inc. BETRIXABAN 40 mg/1 Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC] N 20181231 69856-101_f2c91314-6cbb-4f60-81a1-520ccd866e77 69856-101 HUMAN OTC DRUG Ecosom SALICYLIC ACID, PYRITHIONE ZINC SHAMPOO TOPICAL 20150518 UNAPPROVED DRUG OTHER ECOSOM.Co.,Ltd. SALICYLIC ACID; PYRITHIONE ZINC .2; .6 1/300mL; 1/300mL E 20171231 69856-102_faaa5d5f-9431-4bb8-8f2f-1f995d6dc8b6 69856-102 HUMAN OTC DRUG Ecosom Tonic SALICYLIC ACID, NIACINAMIDE LIQUID TOPICAL 20150520 UNAPPROVED DRUG OTHER ECOSOM.Co.,Ltd. NIACINAMIDE; SALICYLIC ACID .3; .5 1/100g; 1/100g E 20171231 69859-001_28aeb078-b1ff-4de7-9377-f2dfaf645944 69859-001 HUMAN OTC DRUG Chest Rub Menthol, Camphor, Eucalyptus Oil OINTMENT TOPICAL 20150523 OTC MONOGRAPH FINAL part341 JT Cosmetics and Chemicals MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL); EUCALYPTUS OIL 1; 4.7; 1 g/100g; g/100g; g/100g N 20181231 69859-002_a181e8f7-f2e9-4e0c-97c2-727857098437 69859-002 HUMAN OTC DRUG BLUE ICE Menthol GEL TOPICAL 20150523 OTC MONOGRAPH NOT FINAL part348 JT Cosmetics and Chemicals MENTHOL, UNSPECIFIED FORM 2 g/100g N 20181231 69859-003_fec2378f-d00d-47cd-9c96-b39680eff56d 69859-003 HUMAN OTC DRUG A 50% ISOPROPYL Rubbing Alcohol Isopropyl Alcohol LIQUID TOPICAL 20151218 OTC MONOGRAPH NOT FINAL part333A JT Cosmetics and Chemicals ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 69862-001_bbb73081-3e16-409b-9c87-a5db9e438292 69862-001 HUMAN OTC DRUG BIOVITA BACILLUS SUBTILIS, THIAMINE MONONITRATE, Riboflavin, Ascorbic Acid, NIACINAMIDE, CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE GRANULE ORAL 20150603 UNAPPROVED DRUG OTHER ILDONG PHARMACEUTICAL Co., Ltd. BACILLUS SUBTILIS; CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE; THIAMINE MONONITRATE; RIBOFLAVIN; ASCORBIC ACID; NIACINAMIDE 3; 20; .3; .2; 5; .1 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69863-101_99f8dd9f-b9d2-4169-abe8-71850527fab1 69863-101 HUMAN OTC DRUG SMOOTHING MINERAL PRIMER SPF-15 TITANIUM DIOXIDE LOTION TOPICAL 20150618 OTC MONOGRAPH FINAL part352 HATCHBEAUTY PRODUCTS LLC TITANIUM DIOXIDE 6.9 g/100mL E 20171231 69863-102_19889dd4-43a9-4be7-9666-0d2a7eff8744 69863-102 HUMAN OTC DRUG TINTED MOISTURIZER SPF-20 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20150618 OTC MONOGRAPH FINAL part352 HATCHBEAUTY PRODUCTS LLC TITANIUM DIOXIDE; ZINC OXIDE 6.3; 5.9 g/100mL; g/100mL E 20171231 69863-103_903fb17e-baed-43e4-8763-4678ceacccc2 69863-103 HUMAN OTC DRUG EX-GLOW-SION SPF-20 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20151216 OTC MONOGRAPH FINAL part352 HATCHBEAUTY PRODUCTS LLC TITANIUM DIOXIDE; ZINC OXIDE 5.75; 3.7 g/100mL; g/100mL E 20171231 69863-201_897f96e4-cb8a-42a3-97dc-c999b9a48fe5 69863-201 HUMAN OTC DRUG ANTI-BLEMISH CONCEALER SALICYLIC ACID STICK TOPICAL 20150618 OTC MONOGRAPH FINAL part333D HATCHBEAUTY PRODUCTS LLC SALICYLIC ACID 2 g/100g E 20171231 69864-001_5e6ff858-068f-3683-e053-2a91aa0ab199 69864-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION, SOLUTION INTRAVENOUS 20120423 ANDA ANDA203904 The Methodist Hospital Research Institute FLUDEOXYGLUCOSE F-18 .3 Ci/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 69865-210_274e3e2d-6cdf-42a6-aa41-2c51fe5e3e4b 69865-210 HUMAN PRESCRIPTION DRUG Nucynta tapentadol hydrochloride TABLET, FILM COATED ORAL 20170616 NDA NDA022304 Depo NF Sub, LLC TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 69865-220_274e3e2d-6cdf-42a6-aa41-2c51fe5e3e4b 69865-220 HUMAN PRESCRIPTION DRUG Nucynta tapentadol hydrochloride TABLET, FILM COATED ORAL 20170616 NDA NDA022304 Depo NF Sub, LLC TAPENTADOL HYDROCHLORIDE 75 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 69865-230_274e3e2d-6cdf-42a6-aa41-2c51fe5e3e4b 69865-230 HUMAN PRESCRIPTION DRUG Nucynta tapentadol hydrochloride TABLET, FILM COATED ORAL 20170616 NDA NDA022304 Depo NF Sub, LLC TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 69865-240_b833c056-1b5f-490d-9012-76e070f458e0 69865-240 HUMAN PRESCRIPTION DRUG Nucynta ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170616 NDA NDA200533 Depo NF Sub, LLC TAPENTADOL HYDROCHLORIDE 50 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 69865-245_b833c056-1b5f-490d-9012-76e070f458e0 69865-245 HUMAN PRESCRIPTION DRUG Nucynta ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170616 NDA NDA200533 Depo NF Sub, LLC TAPENTADOL HYDROCHLORIDE 100 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 69865-250_b833c056-1b5f-490d-9012-76e070f458e0 69865-250 HUMAN PRESCRIPTION DRUG Nucynta ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170616 NDA NDA200533 Depo NF Sub, LLC TAPENTADOL HYDROCHLORIDE 150 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 69865-260_b833c056-1b5f-490d-9012-76e070f458e0 69865-260 HUMAN PRESCRIPTION DRUG Nucynta ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170616 NDA NDA200533 Depo NF Sub, LLC TAPENTADOL HYDROCHLORIDE 200 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 69865-265_b833c056-1b5f-490d-9012-76e070f458e0 69865-265 HUMAN PRESCRIPTION DRUG Nucynta ER tapentadol hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170616 NDA NDA200533 Depo NF Sub, LLC TAPENTADOL HYDROCHLORIDE 250 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 69866-1025_45501f23-533e-4c7a-9203-2974d40c8a26 69866-1025 HUMAN PRESCRIPTION DRUG CARTICEL autologous cultured chondrocytes IMPLANT INTRA-ARTICULAR 19050619 BLA BLA103661 Vericel Corporation AUTOLOGOUS CULTURED CHONDROCYTES 12000000 1/1 Autologous Cultured Cell [EPC],Cells, Cultured, Autologous [Chemical/Ingredient],Chondrocytes [Chemical/Ingredient] N 20181231 69866-1030_a6afee99-4a95-4488-84d8-7bdea7e9bbe3 69866-1030 CELLULAR THERAPY MACI autologous cultured chondrocytes IMPLANT INTRA-ARTICULAR 20170111 BLA BLA125603 Vericel Corporation AUTOLOGOUS CULTURED CHONDROCYTES; PORK COLLAGEN 15000000; 15 1/1; cm2/1 Autologous Cultured Cell [EPC],Cells, Cultured, Autologous [Chemical/Ingredient],Chondrocytes [Chemical/Ingredient] N 20181231 69871-001_3da1b5ca-81df-4c77-9ba7-d1f33a13752d 69871-001 HUMAN OTC DRUG Jinhwagwangsu Bubble Stearic Acid SOAP TOPICAL 20150601 UNAPPROVED DRUG OTHER CPbio Co., Ltd STEARIC ACID 120 mg/g E 20171231 69871-002_10d187d5-9406-43b9-8c07-e362a52eff0a 69871-002 HUMAN OTC DRUG Obeo Baby Bubble Stearic Acid SOAP TOPICAL 20150529 UNAPPROVED DRUG OTHER CPbio Co., Ltd STEARIC ACID 120 mg/g E 20171231 69871-003_69200821-247e-49a9-b071-45da086721ed 69871-003 HUMAN OTC DRUG Obeo 7way Moisture GLYCERIN LOTION TOPICAL 20160125 UNAPPROVED DRUG OTHER CPbio Co., Ltd GLYCERIN 16 mg/200mL E 20171231 69871-004_1d5fcfa0-4522-4ab4-accc-d40e1e7f99b9 69871-004 HUMAN OTC DRUG Jinhwagwangsu Hair STEARIC ACID SOAP TOPICAL 20160125 UNAPPROVED DRUG OTHER CPbio Co., Ltd STEARIC ACID 12 g/100g E 20171231 69871-005_3e60a23f-1871-47f3-93e5-6d9eddfe619a 69871-005 HUMAN OTC DRUG Obeo The Mee Plus Hair Color Cream Dark Brown P-PHENYLENEDIAMINE CREAM TOPICAL 20160302 UNAPPROVED DRUG OTHER CPbio Co., Ltd P-PHENYLENEDIAMINE 2.39 mg/150g E 20171231 69871-006_f6c2628c-8cd4-4111-9bfa-8f955531beec 69871-006 HUMAN OTC DRUG Obeo The Mee Plus Hair Color Cream Natural Brown P-PHENYLENEDIAMINE CREAM TOPICAL 20160302 UNAPPROVED DRUG OTHER CPbio Co., Ltd P-PHENYLENEDIAMINE 1.2 mg/150g E 20171231 69871-007_aae54416-2e83-4cf7-a86c-5810457ae924 69871-007 HUMAN OTC DRUG Obeo Hair SALICYLIC ACID SHAMPOO TOPICAL 20170515 OTC MONOGRAPH FINAL part358H CPbio Co., Ltd SALICYLIC ACID 9 mg/500g N 20181231 69874-322_21d4ffeb-1411-4e97-81d9-ce62ccbab464 69874-322 HUMAN PRESCRIPTION DRUG QUAZEPAM Quazepam TABLET ORAL 20160412 NDA NDA018708 Thompson Medical Solutions LLC QUAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 69874-422_695e19d0-b09e-4d68-8466-19e1a0a644c0 69874-422 HUMAN PRESCRIPTION DRUG Elavil 25 mg AMITRIPTYLINE HYDROCHLORIDE TABLET ORAL 19970911 ANDA ANDA040218 Thompson Medical Solutions Llc AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 69874-992_b16cb744-b0d8-4f1a-a32e-43b20fe074be 69874-992 HUMAN PRESCRIPTION DRUG Tofranil Imipramine hydrochloride TABLET, SUGAR COATED ORAL 20161223 ANDA ANDA087844 Thompson Medical Solutions LLC IMIPRAMINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] E 20171231 69877-017_491facd5-ead0-3a7f-e054-00144ff8d46c 69877-017 HUMAN PRESCRIPTION DRUG Ascorbic Acid Ascorbic Acid INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20150702 UNAPPROVED DRUG OTHER Raw Materials International Overseas LLC ASCORBIC ACID 500 mg/mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20181231 69877-026_2834fad0-c4c2-48f4-e054-00144ff8d46c 69877-026 HUMAN PRESCRIPTION DRUG Vitamin B Complex thiamine hydrochloride, riboflavin 5 phosphate sodium, pyridoxine hydrochloride, dexpanthenol and niacinamide INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20150706 UNAPPROVED DRUG OTHER Raw Materials International Overseas LLC RIBOFLAVIN 5'-PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; NIACINAMIDE; THIAMINE HYDROCHLORIDE 2; 2; 2; 100; 100 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 69877-031_2834fad0-c4c1-48f4-e054-00144ff8d46c 69877-031 HUMAN PRESCRIPTION DRUG Dehydrated Alcohol Dehydrated Alcohol Injection SOLUTION INTRASPINAL 20150812 UNAPPROVED DRUG OTHER Raw Materials International Overseas LLC ALCOHOL .98 mL/mL E 20171231 69878-001_2368d318-9e15-4a6f-893b-f39eb9efd495 69878-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20150602 NDA NDA205840 Gases Equipment Tools and Supplies Inc OXYGEN 992 mL/L N 20181231 69879-101_6c21dac9-e74d-4adc-9916-2cd1939f975b 69879-101 HUMAN OTC DRUG Cover-Expert Sunscreen Broad Spectrum SPF 15 No.1 Fair Beige TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part352 Luxe Art Beaute SAS TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL N 20181231 69879-102_32d0a792-8fa8-44c9-977f-d3b56354a9fe 69879-102 HUMAN OTC DRUG Cover-Expert Sunscreen Broad Spectrum SPF 15 No.2 Neutral Beige TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part352 Luxe Art Beaute SAS TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL N 20181231 69879-103_e8d553da-9b9d-48ac-bfbb-17748d6eeb6d 69879-103 HUMAN OTC DRUG Cover-Expert Sunscreen Broad Spectrum SPF 15 No.3 Cream Beige TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part352 Luxe Art Beaute SAS TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL N 20181231 69879-104_6d2d09cf-467c-454f-ab24-460ef902541d 69879-104 HUMAN OTC DRUG Cover-Expert Sunscreen Broad Spectrum SPF 15 No.4 Rosy Beige TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part352 Luxe Art Beaute SAS TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL N 20181231 69879-105_e7bd22e5-1584-41ee-a157-abb66a75b605 69879-105 HUMAN OTC DRUG Cover-Expert Sunscreen Broad Spectrum SPF 15 No.5 Peach Beige TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part352 Luxe Art Beaute SAS TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL N 20181231 69879-107_ff4e8e11-e882-493f-abab-816622bf5d73 69879-107 HUMAN OTC DRUG Cover-Expert Sunscreen Broad Spectrum SPF 15 No.7 Vanilla Beige TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part352 Luxe Art Beaute SAS TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL N 20181231 69879-108_3e091c44-9942-422b-9431-b2fa140745a2 69879-108 HUMAN OTC DRUG Luxe Art Beaute SAS (69879-108-35) Cover-Expert Sunscreen Broad Spectrum SPF 15 No.8 Intense Beige, 35ml TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part352 Luxe Art Beaute SAS TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL N 20181231 69879-109_2ff16d4c-1685-474c-b66f-bd58d63e2d6b 69879-109 HUMAN OTC DRUG Cover-Expert Sunscreen Broad Spectrum SPF 15 No.9 Honey Beige TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part352 Luxe Art Beaute SAS TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL N 20181231 69879-111_ee46925f-8f20-4bcb-a995-c3e034f39890 69879-111 HUMAN OTC DRUG Cover-Expert Sunscreen Broad Spectrum SPF 15 No.11 Amber Brown TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part352 Luxe Art Beaute SAS TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL N 20181231 69879-112_3a32374d-212b-45eb-a60f-fdf8348fc604 69879-112 HUMAN OTC DRUG Cover-Expert Sunscreen Broad Spectrum SPF 15 No.12 Warm Copper TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150731 OTC MONOGRAPH NOT FINAL part352 Luxe Art Beaute SAS TITANIUM DIOXIDE; ZINC OXIDE 51; 28 mg/mL; mg/mL N 20181231 69881-003_321a10c7-1ed8-70fa-e054-00144ff8d46c 69881-003 HUMAN OTC DRUG Benchmarks Derma Shield Dimethicone AEROSOL TOPICAL 20160323 OTC MONOGRAPH FINAL part347 Fillcare Limited DIMETHICONE 2.7 g/100g N 20181231 69881-003_321a772c-c44e-3d4e-e054-00144ff8d46c 69881-003 HUMAN OTC DRUG Benchmarks Derma Shield Dimethicone AEROSOL TOPICAL 20160323 OTC MONOGRAPH FINAL part347 Fillcare Limited DIMETHICONE 2.7 g/100g N 20181231 69881-003_321b2266-cbd5-61fb-e054-00144ff8d46c 69881-003 HUMAN OTC DRUG Benchmarks Derma Shield Dimethicone AEROSOL TOPICAL 20160323 OTC MONOGRAPH FINAL part347 Fillcare Limited DIMETHICONE 2.7 g/100g N 20181231 69881-920_6153d401-4321-5837-e053-2991aa0a5fe4 69881-920 HUMAN OTC DRUG ARRID Dry invigorate Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151009 OTC MONOGRAPH FINAL part350 Fillcare Limited ALUMINUM CHLOROHYDRATE .194 g/g N 20181231 69881-921_6153d401-4321-5837-e053-2991aa0a5fe4 69881-921 HUMAN OTC DRUG ARRID Dry Renew Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151009 OTC MONOGRAPH FINAL part350 Fillcare Limited ALUMINUM CHLOROHYDRATE .194 g/g N 20181231 69881-922_6153cd89-4257-93ed-e053-2991aa0a8085 69881-922 HUMAN OTC DRUG ULTRA MAX Dry CONFIDENCE Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151009 OTC MONOGRAPH FINAL part350 Fillcare Limited ALUMINUM CHLOROHYDRATE .194 g/g N 20181231 69881-923_6153cd89-4257-93ed-e053-2991aa0a8085 69881-923 HUMAN OTC DRUG ULTRA MAX Dry PEAK PERFORMANCE Aluminum Chlorohydrate AEROSOL, SPRAY TOPICAL 20151009 OTC MONOGRAPH FINAL part350 Fillcare Limited ALUMINUM CHLOROHYDRATE .194 g/g N 20181231 69882-023_48bc8512-f8fd-451b-e054-00144ff8d46c 69882-023 HUMAN OTC DRUG Apex Crown Anti Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20150529 OTC MONOGRAPH FINAL part358H Restoration Rockstar LLC PYRITHIONE ZINC 20 mg/mL N 20181231 69882-025_618470c1-de2a-9868-e053-2a91aa0a6a8d 69882-025 HUMAN OTC DRUG Wick Storm Tea Tree Antifungal Foot Body Wash TOLNAFTATE LIQUID TOPICAL 20150710 OTC MONOGRAPH FINAL part333C Restoration Rockstar LLC TOLNAFTATE 10 mg/mL N 20181231 69882-726_6184451a-738a-4af3-e053-2a91aa0a4051 69882-726 HUMAN OTC DRUG Signature Black Bottle Tea Tree Antifungal Foot and Body Wash TOLNAFTATE LOTION TOPICAL 20160210 OTC MONOGRAPH FINAL part333C Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle) TOLNAFTATE 10 mg/mL N 20181231 69883-001_dbfa536f-e0d6-48d2-b7a2-9f6da3c013bb 69883-001 HUMAN OTC DRUG Biovem Naja Naja STRIP ORAL 20150215 UNAPPROVED HOMEOPATHIC Biovem NAJA NAJA VENOM 10 [hp_X]/1 E 20171231 69884-703_2c51618c-0626-5d19-e054-00144ff88e88 69884-703 HUMAN OTC DRUG San-X E3 Ethanol LIQUID TOPICAL 20160212 OTC MONOGRAPH NOT FINAL part333E Amerisan, LLC ALCOHOL 62 mL/100mL N 20181231 69884-707_2c51de8f-36dc-6e82-e054-00144ff8d46c 69884-707 HUMAN OTC DRUG San-X E2 Benzalkonium chloride LIQUID TOPICAL 20160219 OTC MONOGRAPH NOT FINAL part333E Amerisan, LLC BENZALKONIUM CHLORIDE .12 mg/100mL N 20181231 69885-610_178f648e-953c-71b9-e054-00144ff8d46c 69885-610 HUMAN OTC DRUG DNA Care Natural SPF 30 Zinc Oxide CREAM TOPICAL 20140115 OTC MONOGRAPH FINAL part352 Tecniche LLC ZINC OXIDE .135 mg/g E 20171231 69886-110_36926090-ed35-4258-e054-00144ff88e88 69886-110 HUMAN OTC DRUG PC HanSan Ethanol LIQUID TOPICAL 20150817 OTC MONOGRAPH NOT FINAL part333E Packers Chemical, Inc. ALCOHOL .71 L/L N 20181231 69888-101_a779a459-9b03-4233-9cf2-4c2c72df8edf 69888-101 HUMAN OTC DRUG PRIMEROSE SNAIL Adenosine CREAM TOPICAL 20150604 UNAPPROVED DRUG OTHER Royal Springs Cosmetics USA, LLC ADENOSINE .0004 1/100mL E 20171231 69888-102_5dd04ed9-93ae-4c94-8006-76744e2b4c1b 69888-102 HUMAN OTC DRUG PRIMEROSE EGF Niacinamide, Dimethicone, Adenosine CREAM TOPICAL 20150608 UNAPPROVED DRUG OTHER Royal Springs Cosmetics USA, LLC NIACINAMIDE; DIMETHICONE; ADENOSINE .02; .015; .0004 1/100mL; 1/100mL; 1/100mL E 20171231 69888-103_640642c4-885a-4582-aa34-f2c7074f8d56 69888-103 HUMAN OTC DRUG PRIMEROSE WHITE MILKY CB Dimethicone, Niacinamide, Panthenol, Adenosine CREAM TOPICAL 20150622 UNAPPROVED DRUG OTHER Royal Springs Cosmetics USA, LLC DIMETHICONE; NIACINAMIDE; PANTHENOL; ADENOSINE .025; .02; .005; .0004 1/80mL; 1/80mL; 1/80mL; 1/80mL E 20171231 69888-104_6353db0b-741e-426b-86b2-86f619b08334 69888-104 HUMAN OTC DRUG PRIMEROSE SNAIL HYDRO ESSENCE Niacinamide GEL TOPICAL 20150625 UNAPPROVED DRUG OTHER Royal Springs Cosmetics USA, LLC NIACINAMIDE .02 1/120mL E 20171231 69888-105_7391acfb-517c-4af9-ba1b-5375993b5638 69888-105 HUMAN OTC DRUG PRIMEROSE DOUBLE EFFECT EYE NIACINAMIDE, ADENOSINE CREAM TOPICAL 20160315 UNAPPROVED DRUG OTHER Royal Springs Cosmetics USA, LLC NIACINAMIDE; ADENOSINE .02; .0004 1/30mL; 1/30mL E 20171231 69889-026_4830e546-7d98-3fb5-e054-00144ff8d46c 69889-026 HUMAN OTC DRUG MTX Topical Pain LIDOCAINE HYDROCHLORIDE, MENTHOL PATCH TOPICAL 20160915 OTC MONOGRAPH NOT FINAL part348 Unik Pharmaceuticals, Inc. LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g N 20181231 69889-027_4830f52a-e9b8-6a41-e054-00144ff88e88 69889-027 HUMAN OTC DRUG CMX Topical Pain MENTHOL, CAPSAICIN PATCH TOPICAL 20160915 OTC MONOGRAPH NOT FINAL part348 Unik Pharmaceuticals, Inc MENTHOL; CAPSAICIN 5; .0375 g/100g; g/100g N 20181231 69890-010_fdc7b831-f053-41f5-b013-3b5bee4444e6 69890-010 HUMAN OTC DRUG AMHEALER Sodium Fluoride SPRAY ORAL 20150501 OTC MONOGRAPH FINAL part355 HEALINGAM CO., LTD SODIUM FLUORIDE .007 mg/35mL E 20171231 69893-001_55a021d7-4937-4b18-8697-88d48379167e 69893-001 HUMAN OTC DRUG Silkriller 3D Gold Pure Rich Gel Glycerin GEL TOPICAL 20140401 OTC MONOGRAPH FINAL part347 Eaudeleman Cosmetic GLYCERIN 13.8 mg/100mL E 20171231 69893-101_42ddc6f6-0e01-4814-845e-015c55f0fc53 69893-101 HUMAN OTC DRUG Silkriller 3D Silver Pure Rich Gel Glycerin GEL TOPICAL 20140401 OTC MONOGRAPH FINAL part347 Eaudleman Cosmetic Co Ltd GLYCERIN 13.8 mg/100mL E 20171231 69893-201_1be9822e-877a-4ea1-8e2b-9c6e8cbd09c5 69893-201 HUMAN OTC DRUG Moisture Cream Glycerin CREAM TOPICAL 20140401 OTC MONOGRAPH FINAL part347 Eaudeleman Cosmetic Co Ltd GLYCERIN 4.2 g/100g E 20171231 69893-301_edf28c63-4c50-44a4-8682-d852dbe6b5a0 69893-301 HUMAN OTC DRUG Eaudeleman Cosmetic UV Liquid Titanium Dioxide LOTION TOPICAL 20140401 OTC MONOGRAPH FINAL part352 Eaudeleman Cosmetic Co Ltd TITANIUM DIOXIDE 5 g/100g E 20171231 69894-040_1f271b0d-4dfa-44fd-af88-bcda39cfd533 69894-040 HUMAN OTC DRUG W HONEY BEAM CUSHION 21 Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 WOW VENTURES TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 69894-050_965b0bee-d41d-44c2-8723-f36cfdcdfafb 69894-050 HUMAN OTC DRUG W HONEY BEAM CUSHION 23 Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 WOW VENTURES TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 69894-060_fba7b3be-26f5-4891-9627-d11104485ca7 69894-060 HUMAN OTC DRUG White Holic 50mL Titanium Dioxide CREAM TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 WOW VENTURES TITANIUM DIOXIDE 1.02 mg/50mL N 20181231 69894-070_7496d56a-bc04-4b59-9fdf-e8c9a1e8d94f 69894-070 HUMAN OTC DRUG White Holic 100mL Titanium Dioxide CREAM TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 WOW VENTURES TITANIUM DIOXIDE 2.05 mg/100mL N 20181231 69894-100_32495787-4fc4-40e9-8729-ff4c52eeafce 69894-100 HUMAN OTC DRUG LIGHT CARE AQUA SUN Octinoxate, Octocrylene, Octisalate, Avobenzone GEL TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 WOW VENTURES OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 3.5; 2.5; 2.25; 2 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 69894-290_92d72973-416e-48a3-b3b6-b654ab0960bc 69894-290 HUMAN OTC DRUG HD WATERFUL BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 WOW VENTURES TITANIUM DIOXIDE; ZINC OXIDE 5.22; .72 mg/50mL; mg/50mL N 20181231 69894-310_a61342ff-6a0f-4604-8e4c-143a8d574313 69894-310 HUMAN OTC DRUG TONE UP WHITE SUN Zinc Oxide, Titanium Dioxide, Octinoxate, Octisalate CREAM TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 WOW VENTURES ZINC OXIDE; TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 3.6; 2.07; 2; 2 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 69894-330_89d17078-821a-4bd7-8d76-37d4935f7671 69894-330 HUMAN OTC DRUG Silky Eye Primer Titanium Dioxide CREAM TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 WOW VENTURES TITANIUM DIOXIDE .04 g/5.5g N 20181231 69894-460_1a40ddbb-7550-4ffd-be66-bf5168484915 69894-460 HUMAN OTC DRUG W Lab BLOSSOM WHITE CUSHION 13 Blossom White Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20161010 OTC MONOGRAPH NOT FINAL part352 WOW VENTURES TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.65; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 69894-470_9e8f05dc-0327-42bc-b7a4-230655f5070b 69894-470 HUMAN OTC DRUG W Lab BLOSSOM WHITE CUSHION 21 Blossom Light Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20161010 OTC MONOGRAPH NOT FINAL part352 WOW VENTURES TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.65; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 69894-480_d6de6f3b-9985-48e7-99f4-0d1c877133d5 69894-480 HUMAN OTC DRUG W Lab BLOSSOM WHITE CUSHION 23 Blossom Beige Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20161010 OTC MONOGRAPH NOT FINAL part352 WOW VENTURES TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.65; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 69896-020_4807ddbe-16d2-6111-e054-00144ff8d46c 69896-020 HUMAN OTC DRUG Goose Grease Menthol CREAM TOPICAL 20150528 OTC MONOGRAPH NOT FINAL part348 ANC Products LLC MENTHOL 12.5 mg/g N 20181231 69896-728_4807ddbe-16e0-6111-e054-00144ff8d46c 69896-728 HUMAN OTC DRUG Goose Grease Recovery and Pain Relief MENTHOL CREAM TOPICAL 20160216 OTC MONOGRAPH NOT FINAL part348 ANC Products LLC MENTHOL 12.5 mg/mL N 20181231 69898-003_62969057-f940-ab40-e053-2991aa0a2844 69898-003 HUMAN OTC DRUG Swiss Navy EnduranceRx LIDOCAINE SPRAY TOPICAL 20170804 OTC MONOGRAPH FINAL part348 MD Science Lab, LLC LIDOCAINE 10 mg/mL N 20191231 69901-522_aa2f26ae-e278-4eca-86b4-b26562b352be 69901-522 HUMAN OTC DRUG Vicks VapoSteam Camphor (synthetic) LIQUID RESPIRATORY (INHALATION) 19950228 OTC MONOGRAPH FINAL part341 Kaz USA, Inc CAMPHOR (SYNTHETIC) .062 g/mL E 20171231 69903-001_3bf5271b-3218-4720-aac2-71c8be2e9205 69903-001 HUMAN OTC DRUG Dr. Numb Lidocaine CREAM TOPICAL 20160701 OTC MONOGRAPH FINAL part346 Shinpharma Inc LIDOCAINE 1.5 g/30g N 20181231 69903-002_646342cb-701a-4a5c-ac24-d0e36f09e117 69903-002 HUMAN OTC DRUG Dr. Numb Lidocaine and Benzethonium Chloride Cream CREAM TOPICAL 20170912 OTC MONOGRAPH NOT FINAL part348 Shinpharma Inc LIDOCAINE; BENZETHONIUM CHLORIDE 4; .25 mg/50g; mg/50g N 20181231 69903-003_4d6b59ec-6bc0-4ee0-98b9-ad4860e0f4ee 69903-003 HUMAN OTC DRUG Dr. Numb Lidocaine CREAM TOPICAL 20171012 OTC MONOGRAPH FINAL part346 Shinpharma Inc LIDOCAINE 1.2 g/30g N 20181231 69904-0001_1a4b714f-2853-2b8a-e054-00144ff8d46c 69904-0001 HUMAN OTC DRUG Arnica Pain Relief Menthol CREAM TOPICAL 20150619 OTC MONOGRAPH NOT FINAL part348 Accupack Midwest MENTHOL 3.7 g/100g N 20181231 69906-022_48a9c577-65a3-541a-e054-00144ff8d46c 69906-022 HUMAN OTC DRUG plantogen Protective Moisturizer Broad Spectrum SPF Octinoxate, Zinc Oxide, Octyl Salicylate CREAM TOPICAL 20150528 OTC MONOGRAPH NOT FINAL part352 Ollie Pippa International Inc. OCTINOXATE; ZINC OXIDE; OCTISALATE 50; 25; 20 mg/mL; mg/mL; mg/mL N 20181231 69909-001_183935e8-6179-545b-e054-00144ff8d46c 69909-001 HUMAN OTC DRUG anti-bacterial hand gel ETHYL ALCOHOL GEL TOPICAL 20150611 OTC MONOGRAPH NOT FINAL part333E GASSER, MOHAMED ALCOHOL 62 mL/100mL N 20181231 69911-474_caf84084-b71d-483b-a0be-24e66a6a21bc 69911-474 PLASMA DERIVATIVE AFSTYLA Antihemophilic Factor (Recombinant), Single Chain ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT KIT 20160525 BLA BLA125591 CSL Behring Recombinant facility AG N 20181231 69911-475_caf84084-b71d-483b-a0be-24e66a6a21bc 69911-475 PLASMA DERIVATIVE AFSTYLA Antihemophilic Factor (Recombinant), Single Chain ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT KIT 20160525 BLA BLA125591 CSL Behring Recombinant facility AG N 20181231 69911-476_caf84084-b71d-483b-a0be-24e66a6a21bc 69911-476 PLASMA DERIVATIVE AFSTYLA Antihemophilic Factor (Recombinant), Single Chain ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT KIT 20160525 BLA BLA125591 CSL Behring Recombinant facility AG N 20181231 69911-477_caf84084-b71d-483b-a0be-24e66a6a21bc 69911-477 PLASMA DERIVATIVE AFSTYLA Antihemophilic Factor (Recombinant), Single Chain ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT KIT 20160525 BLA BLA125591 CSL Behring Recombinant facility AG N 20181231 69911-478_caf84084-b71d-483b-a0be-24e66a6a21bc 69911-478 PLASMA DERIVATIVE AFSTYLA Antihemophilic Factor (Recombinant), Single Chain ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT KIT 20160525 BLA BLA125591 CSL Behring Recombinant facility AG N 20181231 69911-480_caf84084-b71d-483b-a0be-24e66a6a21bc 69911-480 PLASMA DERIVATIVE AFSTYLA Antihemophilic Factor (Recombinant), Single Chain ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT KIT 20170328 BLA BLA125591 CSL Behring Recombinant facility AG N 20181231 69911-481_caf84084-b71d-483b-a0be-24e66a6a21bc 69911-481 PLASMA DERIVATIVE AFSTYLA Antihemophilic Factor (Recombinant), Single Chain ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT KIT 20170328 BLA BLA125591 CSL Behring Recombinant facility AG N 20181231 69911-864_eb16658d-1ea5-474b-b720-e64b1e61307e 69911-864 PLASMA DERIVATIVE IDELVION Coagulation Factor IX Recombinant Human KIT 20160304 BLA BLA125582 CSL Behring Recombinant Facility AG N 20181231 69911-865_eb16658d-1ea5-474b-b720-e64b1e61307e 69911-865 PLASMA DERIVATIVE IDELVION Coagulation Factor IX Recombinant Human KIT 20160304 BLA BLA125582 CSL Behring Recombinant Facility AG N 20181231 69911-866_eb16658d-1ea5-474b-b720-e64b1e61307e 69911-866 PLASMA DERIVATIVE IDELVION Coagulation Factor IX Recombinant Human KIT 20160304 BLA BLA125582 CSL Behring Recombinant Facility AG N 20181231 69911-867_eb16658d-1ea5-474b-b720-e64b1e61307e 69911-867 PLASMA DERIVATIVE IDELVION Coagulation Factor IX Recombinant Human KIT 20160304 BLA BLA125582 CSL Behring Recombinant Facility AG N 20181231 69913-350_3cdf1975-2622-14f5-e054-00144ff8d46c 69913-350 HUMAN PRESCRIPTION DRUG Ruconest c1 esterase inhibitor recombinant INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160919 BLA BLA125495 Tjoapack Netherlands BV CONESTAT ALFA 2100 U/1 N 20181231 69915-001_06e59e9c-1ece-4ae4-bab2-5f2547134257 69915-001 HUMAN OTC DRUG Active Clear Facial Wash Salicylic Acid LIQUID TOPICAL 20150612 OTC MONOGRAPH FINAL part333D Seacret Spa LLC SALICYLIC ACID 20 mg/mL N 20181231 69915-002_2163cc02-5d79-4858-be3c-51a113f5c3a2 69915-002 HUMAN OTC DRUG Seacret CC Cream Color Corrector OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150713 OTC MONOGRAPH NOT FINAL part352 SEACRET SPA LLC OCTINOXATE; TITANIUM DIOXIDE 4; 1.84 g/40g; g/40g N 20181231 69915-003_21940adf-c437-4a84-842e-14dfe33a351e 69915-003 HUMAN OTC DRUG Seacret Clear Active Clear Facial Wash SALICYLIC ACID LIQUID TOPICAL 20150713 OTC MONOGRAPH FINAL part333D SEACRET SPA LLC SALICYLIC ACID 2 g/100mL N 20181231 69915-004_4e9e24bf-58f0-4572-b379-90e48df0193c 69915-004 HUMAN OTC DRUG Seacret CC Cream Color Corrector Broad Spectrum SPF 15 Light OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150713 OTC MONOGRAPH NOT FINAL part352 SEACRET SPA LLC OCTINOXATE; TITANIUM DIOXIDE 4; 1.84 g/40g; g/40g N 20181231 69915-005_255ae7c1-0bd7-4e52-b49b-0339ea1506c8 69915-005 HUMAN OTC DRUG Seacret CC Cream Color Corrector Broad Spectrum SPF 15 - Medium OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150713 OTC MONOGRAPH NOT FINAL part352 SEACRET SPA LLC OCTINOXATE; TITANIUM DIOXIDE 4; 1.84 g/40g; g/40g N 20181231 69915-006_848cc5a8-b0c8-4000-99bb-378f84cc5195 69915-006 HUMAN OTC DRUG Seacret CC Cream Color Corrector Broad Spectrum SPF 15 - Dark OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20150713 OTC MONOGRAPH NOT FINAL part352 SEACRET SPA LLC OCTINOXATE; TITANIUM DIOXIDE 4; 1.84 g/40g; g/40g N 20181231 69916-035_31112335-e6c0-4c10-b5db-8cf4c4c74d65 69916-035 HUMAN PRESCRIPTION DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20150730 NDA NDA022418 Tribute Pharmaceuticals US, Inc. FENOFIBRIC ACID 35 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] E 20171231 69916-105_31112335-e6c0-4c10-b5db-8cf4c4c74d65 69916-105 HUMAN PRESCRIPTION DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20150730 NDA NDA022418 Tribute Pharmaceuticals US, Inc. FENOFIBRIC ACID 105 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] E 20171231 69918-101_b539b1b0-5551-4abc-9ea6-2ebe9a67db68 69918-101 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20080505 NDA NDA019955 Amring Pharmaceuticals Inc. DESMOPRESSIN ACETATE .1 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 69918-201_b539b1b0-5551-4abc-9ea6-2ebe9a67db68 69918-201 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate TABLET ORAL 20080505 NDA NDA019955 Amring Pharmaceuticals Inc. DESMOPRESSIN ACETATE .2 mg/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 69918-301_c520a9a4-7764-40b7-b261-9070216870c1 69918-301 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid TABLET ORAL 20160301 NDA AUTHORIZED GENERIC NDA022430 Amring Pharmaceuticals, Inc. TRANEXAMIC ACID 650 mg/1 Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 69918-501_e904b7bc-16c7-4597-91b6-c25ad890cfe1 69918-501 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate SPRAY NASAL 20160301 NDA AUTHORIZED GENERIC NDA017922 Amring Pharmaceuticals, Inc. DESMOPRESSIN ACETATE 10 ug/.1mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 69918-899_e9be4ef2-067c-4c01-b1cc-7bb6f464c0ba 69918-899 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate SOLUTION INTRAVENOUS 19991026 NDA NDA018938 Amring Pharmaceuticals Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 69918-901_e9be4ef2-067c-4c01-b1cc-7bb6f464c0ba 69918-901 HUMAN PRESCRIPTION DRUG Desmopressin Acetate Desmopressin Acetate SOLUTION INTRAVENOUS 19991026 NDA NDA018938 Amring Pharmaceuticals Inc. DESMOPRESSIN ACETATE 4 ug/mL Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20181231 69919-021_4807fb60-8d17-6e61-e054-00144ff8d46c 69919-021 HUMAN OTC DRUG humane acne wash Benzoly Peroxide CREAM TOPICAL 20150528 OTC MONOGRAPH FINAL part333D Humane Consumer, LLC BENZOYL PEROXIDE 100 mg/mL N 20181231 69921-024_47f4d4c4-fb3a-5e0e-e054-00144ff8d46c 69921-024 HUMAN OTC DRUG Dr. Carrasco Pain Relief MENTHOL CREAM TOPICAL 20150621 OTC MONOGRAPH NOT FINAL part348 Carrasco Enterprises, Inc. MENTHOL 40 mg/mL N 20181231 69922-001_1ab05763-cf07-4719-98c2-58114a98c093 69922-001 HUMAN OTC DRUG Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35 Octinoxate and Oxybenzone CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part352 Groupe Marcelle Inc. OCTINOXATE; OXYBENZONE 2.25; .9 g/30mL; g/30mL N 20181231 69922-002_04dd2716-13b0-4f52-ab1a-74fbfd6692fb 69922-002 HUMAN OTC DRUG Marcelle City Tinted Cream SPF 25 Octinoxate Sunscreen Octinoxate CREAM TOPICAL 20170605 OTC MONOGRAPH NOT FINAL part352 Groupe Marcelle Inc. OCTINOXATE 2.25 g/30mL N 20181231 69924-006_6084d2ba-5ccc-1ab5-e053-2a91aa0a158e 69924-006 HUMAN OTC DRUG NEOGEN DERMALOGY Day-Light Protection Sun Screen SPF50 TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20171214 OTC MONOGRAPH NOT FINAL part352 OUTIN FUTURES CORP. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.51; .42; 1.31 g/46.78g; g/46.78g; g/46.78g N 20181231 69924-025_5e7a674c-1001-20a9-e053-2991aa0ac1a5 69924-025 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK AGE CURE AMPOULE 1 GLYCERIN LIQUID TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. GLYCERIN 1.01 mg/2.8mL N 20181231 69924-026_5e7a674c-1001-20a9-e053-2991aa0ac1a5 69924-026 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK AGE CURE AMPOULE 2 GLYCERIN LIQUID TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. GLYCERIN .58 mg/2.8mL N 20181231 69924-027_5e7a674c-1001-20a9-e053-2991aa0ac1a5 69924-027 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK AGE CURE MASK GLYCERIN PATCH TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. GLYCERIN 5.56 mg/27mL N 20181231 69924-028_5e7a674c-100d-20a9-e053-2991aa0ac1a5 69924-028 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK HYDRO LIFT AMPOULE 1 DIMETHICONE LIQUID TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. DIMETHICONE .03 mg/2.8mL N 20181231 69924-029_5e7a674c-100d-20a9-e053-2991aa0ac1a5 69924-029 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK HYDRO LIFT AMPOULE 2 GLYCERIN LIQUID TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. GLYCERIN .58 mg/2.8mL N 20181231 69924-030_5e7a674c-100d-20a9-e053-2991aa0ac1a5 69924-030 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK HYDRO LIFT MASK GLYCERIN PATCH TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. GLYCERIN 5.56 mg/27mL N 20181231 69924-031_5e7b118a-04f9-f932-e053-2991aa0a0514 69924-031 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK ILLUMINATION AMPOULE 1 GLYCERIN LIQUID TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. GLYCERIN .57 mg/2.8mL N 20181231 69924-032_5e7b118a-04f9-f932-e053-2991aa0a0514 69924-032 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK ILLUMINATION AMPOULE 2 GLYCERIN LIQUID TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. GLYCERIN .58 mg/2.8mL N 20181231 69924-033_5e7b118a-04f9-f932-e053-2991aa0a0514 69924-033 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK ILLUMINATION MASK GLYCERIN PATCH TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. GLYCERIN 5.56 mg/27mL N 20181231 69924-034_5e7a674c-1019-20a9-e053-2991aa0ac1a5 69924-034 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK INTENSIVE WHITE AMPOULE 1 DIMETHICONE LIQUID TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. DIMETHICONE .03 mg/2.8mL N 20181231 69924-035_5e7a674c-1019-20a9-e053-2991aa0ac1a5 69924-035 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK INTENSIVE WHITE AMPOULE 2 GLYCERIN LIQUID TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. GLYCERIN .58 mg/2.8mL N 20181231 69924-036_5e7a674c-1019-20a9-e053-2991aa0ac1a5 69924-036 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK INTENSIVE WHITE MASK GLYCERIN PATCH TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. GLYCERIN 5.55 mg/27mL N 20181231 69924-037_5e7ae00a-5491-6727-e053-2991aa0a883c 69924-037 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK NUTRIENT AMPOULE 1 DIMETHICONE LIQUID TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. DIMETHICONE .03 mg/2.8mL N 20181231 69924-038_5e7ae00a-5491-6727-e053-2991aa0a883c 69924-038 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK NUTRIENT AMPOULE 2 GLYCERIN LIQUID TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. GLYCERIN .58 mg/2.8mL N 20181231 69924-039_5e7ae00a-5491-6727-e053-2991aa0a883c 69924-039 HUMAN OTC DRUG OOZOO FACE IN-SHOT MASK NUTRIENT MASK GLYCERIN PATCH TOPICAL 20160906 OTC MONOGRAPH FINAL part347 OUTIN FUTURES CORP. GLYCERIN 5.56 mg/27mL N 20181231 69924-043_014145ca-3909-492e-8cc7-f0f9435ddc3e 69924-043 HUMAN OTC DRUG NEOGEN DERMALOGY DAY LIGHT PROTECTION SUN SCREEN SPF50 Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20171214 OTC MONOGRAPH NOT FINAL part352 OUTIN FUTURES CORP. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .04; .37; .14 g/5mL; g/5mL; g/5mL N 20181231 69926-001_cbb0f401-ee2f-45fe-81dd-f252a17922eb 69926-001 HUMAN OTC DRUG Too Cool For School DINO PLATZ CINEMA CITY (CC Highlighter) Octinoxate, Octisalate, Titanium Dioxide, and Zinc Oxide KIT 20150901 OTC MONOGRAPH NOT FINAL part352 Too Cool For School USA, Inc E 20171231 69926-002_43ed2ad1-f08f-4f3e-b2ad-6dad6b16699f 69926-002 HUMAN OTC DRUG Too Cool For School DINO PLATZ CINEMA CITY (CC CHEEK) Octinoxate, Octisalate, Titanium Dioxide, and Zinc Oxide KIT 20150901 OTC MONOGRAPH NOT FINAL part352 Too Cool For School USA, Inc E 20171231 69926-003_6ef5d0cc-0517-4a54-99a4-274a142b0950 69926-003 HUMAN OTC DRUG Too Cool For School DINO PLATZ CINEMA CITY (CC CONCEALER) Octinoxate, Octisalate, Titanium Dioxide, and Zinc Oxide KIT 20150901 OTC MONOGRAPH NOT FINAL part352 Too Cool For School USA, Inc E 20171231 69926-004_cb60cba0-5acf-434c-bb15-17178dfab49d 69926-004 HUMAN OTC DRUG Too Cool For School DINOPLATZ LOOSE and SILLY No. 1 Definition Octinoxate, Octisalate, and Zinc Oxide POWDER TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 Too Cool For School USA, Inc OCTINOXATE; OCTISALATE; ZINC OXIDE 3.75; 2.5; 4.8 g/100g; g/100g; g/100g E 20171231 69926-005_a7800bf4-d863-47ad-863f-bf82af70fdd6 69926-005 HUMAN OTC DRUG Too Cool For School DINOPLATZ LOOSE and SILLY No. 2 Illusion Octinoxate, Octisalate, Titanium Dioxide, and Zinc Oxide POWDER TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 Too Cool For School USA, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 2.5; 7.8; 4.8 g/100g; g/100g; g/100g; g/100g E 20171231 69926-008_b007c7aa-a57c-443a-b556-9252181fa7ca 69926-008 HUMAN OTC DRUG Too Cool For School DINOPLATZ La Ola Viento No.21 ENSULIZOLE, OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE KIT 20150901 OTC MONOGRAPH NOT FINAL part352 Too Cool For School USA, Inc E 20171231 69926-009_b007c7aa-a57c-443a-b556-9252181fa7ca 69926-009 HUMAN OTC DRUG Too Cool For School DINOPLATZ La Ola Noche No.23 ENSULIZOLE, OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE KIT 20150901 OTC MONOGRAPH NOT FINAL part352 Too Cool For School USA, Inc E 20171231 69927-001_48173f3e-8435-4f75-9f9c-649192633cad 69927-001 HUMAN OTC DRUG Balmers Cooling Zone 31 PYRITHIONE ZINC SHAMPOO TOPICAL 20150720 OTC MONOGRAPH FINAL part358H Tae Eul Bi Co., Ltd. PYRITHIONE ZINC 1.05 g/100mL E 20171231 69927-002_d2c75c52-ac86-43fc-bee1-999adc2258a1 69927-002 HUMAN OTC DRUG Balmers Hanryeoncho W COCAMIDOPROPYL BETAINE SHAMPOO TOPICAL 20150720 UNAPPROVED DRUG OTHER Tae Eul Bi Co., Ltd. COCAMIDOPROPYL BETAINE 24 g/100mL E 20171231 69927-003_fdb5529d-da0c-4084-8096-15afef8bcc4d 69927-003 HUMAN OTC DRUG Balmers Hanryeoncho Scalp Scooling mud pack GLYCERIN LIQUID TOPICAL 20150720 OTC MONOGRAPH FINAL part347 Tae Eul Bi Co., Ltd. GLYCERIN 2.5 g/100g E 20171231 69927-004_c94a8247-a819-4b46-b63b-97a344189ee9 69927-004 HUMAN OTC DRUG Balmers Hanryeoncho SuSeungHwa FALLOPIA MULTIFLORA ROOT PILL TOPICAL 20150720 UNAPPROVED DRUG OTHER Tae Eul Bi Co., Ltd. FALLOPIA MULTIFLORA ROOT 18 g/100g E 20171231 69932-001_47e9e921-3792-4c77-93a6-853577414c32 69932-001 HUMAN PRESCRIPTION DRUG Axumin Fluciclovine F-18 INJECTION, SOLUTION INTRAVENOUS 20160527 NDA NDA208054 Blue Earth Diagnostics FLUCICLOVINE F-18 221 mCi/mL Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA] N 20181231 69933-101_953d694a-84d7-456d-b197-e5a231e9f0b8 69933-101 HUMAN OTC DRUG RUE Beaute Grapefruit Hand Sanitizer ALCOHOL LIQUID TOPICAL 20150803 OTC MONOGRAPH NOT FINAL part333E Pearl World INC. ALCOHOL 62 mL/100mL E 20171231 69933-102_19d30ad3-eada-4a77-8d18-5184121c21f9 69933-102 HUMAN OTC DRUG RUE Beaute Strawberry Hand Sanitizer ALCOHOL LIQUID TOPICAL 20150803 OTC MONOGRAPH NOT FINAL part333E Pearl World INC. ALCOHOL 62 mL/100mL E 20171231 69933-103_1db5a98a-0183-4b83-8b98-5afe57cacb9e 69933-103 HUMAN OTC DRUG RUE Beaute Cherry Hand Sanitizer ALCOHOL LIQUID TOPICAL 20150803 OTC MONOGRAPH NOT FINAL part333E Pearl World INC. ALCOHOL 62 mL/100mL E 20171231 69933-104_5e789f23-bc1f-4a78-973f-7ea36638b72d 69933-104 HUMAN OTC DRUG RUE Beaute Vanilla Cupcake Hand Sanitizer ALCOHOL LIQUID TOPICAL 20150803 OTC MONOGRAPH NOT FINAL part333E Pearl World INC. ALCOHOL 62 mL/100mL E 20171231 69934-001_4af0fa10-d5d8-472a-bbab-14e81f731c12 69934-001 HUMAN OTC DRUG XJOW Menthol GEL TOPICAL 20170115 OTC MONOGRAPH NOT FINAL part348 Omom Pharmaceuticals, Inc. MENTHOL, UNSPECIFIED FORM 1.25 g/100g N 20181231 69937-001_2f19a887-5b09-44ca-9588-3a7d138b468b 69937-001 HUMAN OTC DRUG SUSANNE KAUFMANN SUNCARE BODY BROAD SPECTRUM PROTECTION SUNSCREEN SPF 25 UVB UVA AVOBENZONE, ENSULIZOLE, OCTOCRYLENE LOTION TOPICAL 20150727 OTC MONOGRAPH NOT FINAL part352 Susanne Kaufmann Kosmetik GmbH OCTOCRYLENE; AVOBENZONE; ENSULIZOLE 4; 3; 2.5 mg/100mL; mg/100mL; mg/100mL N 20181231 69937-002_bf57b01d-2b94-41de-9e2c-d7fadb68000d 69937-002 HUMAN OTC DRUG SUSANNE KAUFMANN SUNCARE FACE BROAD SPECTRUM PROTECTION SUNSCREEN SPF 30 UVB UVA ZINC OXIDE LOTION TOPICAL 20170601 OTC MONOGRAPH FINAL part352 Susanne Kaufmann Kosmetik GmbH ZINC OXIDE 30 mg/mL N 20181231 69938-151_26a20bc3-01f0-4ed7-e054-00144ff88e88 69938-151 HUMAN PRESCRIPTION DRUG Medicated DNA Collection Kit lidocaine hydrochloride, glycerin SOLUTION ORAL; TOPICAL 20151204 ANDA ANDA040014 TrueFit RX LLC LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 69938-153_2b5e3cf2-89b7-071d-e054-00144ff88e88 69938-153 HUMAN PRESCRIPTION DRUG Disposable Convenience Kit (Single Shot Epidural) lidocaine hydrochloride, sodium chloride, proidone iodine, Bupivacaine KIT 20160204 UNAPPROVED DRUG OTHER True Fit RX LLC E 20171231 69939-051_e6c5d052-96f1-425f-bb6d-317d3b7edf80 69939-051 HUMAN OTC DRUG Careline Skin Guard SPF 30 OXYBENZONE,HOMOSALATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE GEL TOPICAL 20150902 OTC MONOGRAPH NOT FINAL part352 COSMOPHARM LTD. OXYBENZONE; HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 4; 10; 5; 15; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 69939-129_9321ffab-85c1-4d45-a713-8c5e7ac85f6d 69939-129 HUMAN OTC DRUG Orbitol Whitening Sodium Fluoride MOUTHWASH ORAL 20160413 OTC MONOGRAPH FINAL part355 COSMOPHARM LTD SODIUM FLUORIDE .15 g/100g E 20171231 69939-165_c51548fa-9eff-4293-a3da-9fc20edef7db 69939-165 HUMAN OTC DRUG Careline Anti-Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20150903 OTC MONOGRAPH FINAL part358H COSMOPHARM LTD. PYRITHIONE ZINC 1 g/100g N 20181231 69939-291_a8b918d2-79ce-4210-af64-e2be7b95d03c 69939-291 HUMAN OTC DRUG Tayadent With Fluoride Sodium Monofluorophosphate LIQUID DENTAL 20160204 OTC MONOGRAPH FINAL part355 COSMOPHARM LTD. SODIUM MONOFLUOROPHOSPHATE .4 g/100g N 20181231 69939-306_b5aef592-dbfe-45e8-be09-5938221b77fe 69939-306 HUMAN OTC DRUG Orbitol SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20160630 OTC MONOGRAPH FINAL part355 COSMOPHARM LTD. SODIUM MONOFLUOROPHOSPHATE .8 g/100g E 20171231 69939-309_ae2207ab-1b17-4572-81ba-faee3ee0deb9 69939-309 HUMAN OTC DRUG Orbitol SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20160630 OTC MONOGRAPH FINAL part355 COSMOPHARM LTD. SODIUM MONOFLUOROPHOSPHATE .8 g/100g E 20171231 69939-310_a9156cb0-d2f4-47e4-9bec-5e61cc3af5ae 69939-310 HUMAN OTC DRUG Orbitol SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20160706 OTC MONOGRAPH FINAL part355 COSMOPHARM LTD. SODIUM MONOFLUOROPHOSPHATE .8 g/100g E 20171231 69939-311_d0e58f8e-6606-490a-bd97-cf8e811aec8e 69939-311 HUMAN OTC DRUG Orbitol SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20160706 OTC MONOGRAPH FINAL part355 COSMOPHARM LTD. SODIUM MONOFLUOROPHOSPHATE .8 g/100g E 20171231 69939-313_570e32bb-8665-441b-9395-dae3eaee4722 69939-313 HUMAN OTC DRUG Orbitol Sodium Monofluorophosphate PASTE DENTAL 20161205 OTC MONOGRAPH FINAL part355 COSMOPHARM LTD. SODIUM MONOFLUOROPHOSPHATE .4 g/100g E 20171231 69939-323_40c5a555-8a66-4b98-9091-4a0ae921b9b9 69939-323 HUMAN OTC DRUG Orbitol Sodium Monofluorophosphate PASTE TOPICAL 20160208 OTC MONOGRAPH FINAL part355 COSMOPHARM LTD. SODIUM MONOFLUOROPHOSPHATE .74 g/100g N 20181231 69939-408_538ac009-41bc-4d26-b49e-655b91aa0cee 69939-408 HUMAN OTC DRUG Careline Revival Plus OCTINOXATE,OCTISALATE,AVOBENZONE CREAM TOPICAL 20150917 OTC MONOGRAPH NOT FINAL part352 COSMOPHARM LTD. OCTINOXATE; OCTISALATE; AVOBENZONE 7.5; 4; 2 g/100g; g/100g; g/100g N 20181231 69939-625_ab5882b0-7e33-4487-94d7-d16ec01e8ff0 69939-625 HUMAN OTC DRUG Careline Skin Guard Invisible SPF 50 HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE,OXYBENZONE SPRAY TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part352 COSMOPHARM LTD. HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; OXYBENZONE 10; 10; 5; 5; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 69939-626_1cc41bb1-3d67-49a9-9831-bfbd903fd272 69939-626 HUMAN OTC DRUG Careline Skin Guard Kids Invisible SPF 50 HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE,OXYBENZONE SPRAY TOPICAL 20150930 OTC MONOGRAPH NOT FINAL part352 COSMOPHARM LTD. HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; OXYBENZONE 10; 10; 5; 5; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 69939-643_fa2756b2-a4c9-4ff8-b6d3-393abcf6a488 69939-643 HUMAN OTC DRUG Careline Antigravity OCTOCRYLENE,AVOBENZONE,ALLANTOIN CREAM TOPICAL 20150917 OTC MONOGRAPH NOT FINAL part352 COSMOPHARM LTD. OCTOCRYLENE; AVOBENZONE; ALLANTOIN 10; 3.15; .2 g/100g; g/100g; g/100g N 20181231 69939-645_8f815219-7ff5-4246-83b4-888a6cedc4d8 69939-645 HUMAN OTC DRUG Careline Perfect Care BB TITANIUM DIOXIDE,OCTINOXATE,ALLANTOIN,TALC,CAFFEINE CREAM TOPICAL 20150917 OTC MONOGRAPH NOT FINAL part352 COSMOPHARM LTD. TITANIUM DIOXIDE; OCTINOXATE; ALLANTOIN; TALC; CAFFEINE 2.5; 4; .2; 2.5; .2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 69939-690_33e39a2e-9179-4cc1-9602-3d0730880708 69939-690 HUMAN OTC DRUG Careline Perfect Care BB TITANIUM DIOXIDE,OCTINOXATE,ALLANTOIN,TALC,CAFFEINE CREAM TOPICAL 20150917 OTC MONOGRAPH NOT FINAL part352 COSMOPHARM LTD. TITANIUM DIOXIDE; OCTINOXATE; ALLANTOIN; TALC; CAFFEINE 5; 4; .2; 2.5; .2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 69942-015_566bed56-2c60-58e8-e054-00144ff8d46c 69942-015 HUMAN OTC DRUG Moroccan oil Sun Oil Avobenzone, Octinoxate, Octisalate, Octocrylene SPRAY TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 Moroccanoil, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 6.993; 3; 7; 3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69942-030_56696421-fa94-5107-e054-00144ff8d46c 69942-030 HUMAN OTC DRUG Moroccanoil Sun Oil Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 Moroccanoil, Inc. HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 12; 5; 6; 2.5; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69942-050_567cd2db-d189-4fc3-e054-00144ff88e88 69942-050 HUMAN OTC DRUG Moroccanoil Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 Moroccanoil, Inc. HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE 15; 5; 2.7; 6; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 69945-010_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-010 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 1 Ci/1 N 20181231 69945-015_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-015 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 1.5 Ci/1 N 20181231 69945-020_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-020 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 2 Ci/1 N 20181231 69945-025_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-025 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 2.5 Ci/1 N 20181231 69945-030_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-030 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 3 Ci/1 N 20181231 69945-035_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-035 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 3.5 Ci/1 N 20181231 69945-050_59985f96-e0f2-4447-b81e-722cd908c328 69945-050 HUMAN PRESCRIPTION DRUG OCTREOSCAN Indium In -111 Pentetreotide KIT 20151014 NDA NDA020314 MALLINCKRODT NUCLEAR MEDICINE LLC N 20181231 69945-051_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-051 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 5 Ci/1 N 20181231 69945-060_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-060 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 6 Ci/1 N 20181231 69945-068_0e664843-e0c5-4d16-a345-40f40dac2378 69945-068 HUMAN PRESCRIPTION DRUG Ultratag RBC Technetium Tc 99m-Labeled Red Blood Cells KIT 19910610 NDA NDA019981 MALLINCKRODT NUCLEAR MEDICINE LLC N 20181231 69945-075_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-075 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 7.5 Ci/1 N 20181231 69945-091_f103f510-098a-48bc-b005-5c645b34d0d0 69945-091 HUMAN PRESCRIPTION DRUG Technescan HDP Technetium Tc 99m Oxidronate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20151013 NDA NDA018321 MALLINCKRODT NUCLEAR MEDICINE LLC OXIDRONATE DISODIUM 3.15 mg/1 N 20181231 69945-092_c4c9366f-0da2-4079-84a9-185fd7e49e26 69945-092 HUMAN PRESCRIPTION DRUG Technetium Tc 99m Sestamibi Technetium Tc 99m Sestamibi INJECTION INTRAVENOUS 20111031 ANDA ANDA078098 MALLINCKRODT NUCLEAR MEDICINE LLC TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/mL N 20181231 69945-094_9e311168-5cf3-481a-8412-ae5879d4694c 69945-094 HUMAN PRESCRIPTION DRUG Technescan PYP Technetium Tc 99m Pyrophosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20151014 NDA NDA017538 MALLINCKRODT NUCLEAR MEDICINE LLC SODIUM PYROPHOSPHATE; STANNOUS CHLORIDE 11.9; 3.2 mg/10mL; mg/10mL N 20181231 69945-096_38eab466-50aa-4f39-90d0-62f80a49f1d5 69945-096 HUMAN PRESCRIPTION DRUG Technescan MAG3 Technescan Tc 99m Mertiatide INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 19900615 NDA NDA019882 MALLINCKRODT NUCLEAR MEDICINE LLC BETIATIDE 1 mg/1 N 20181231 69945-097_a2947596-d8a8-43ac-84ed-e2ec339e3b59 69945-097 HUMAN PRESCRIPTION DRUG Xenon, Xe-133 Xenon GAS RESPIRATORY (INHALATION) 20160330 NDA NDA018327 MALLINCKRODT NUCLEAR MEDICINE LLC XENON XE-133 5 mCi/mL Inhalation Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 69945-098_a2947596-d8a8-43ac-84ed-e2ec339e3b59 69945-098 HUMAN PRESCRIPTION DRUG Xenon, Xe-133 Xenon GAS RESPIRATORY (INHALATION) 20160330 NDA NDA018327 MALLINCKRODT NUCLEAR MEDICINE LLC XENON XE-133 10 mCi/mL Inhalation Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 69945-110_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-110 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 11 Ci/1 N 20181231 69945-120_efe0ad90-2dab-4606-b17e-41e2ff8e56bf 69945-120 HUMAN PRESCRIPTION DRUG THALLOUS CHLORIDE Tl 201 thallous chloride, Tl 201 INJECTION, SOLUTION INTRAVENOUS 20151104 NDA NDA018150 MALLINCKRODT NUCLEAR MEDICINE LLC THALLOUS CHLORIDE TL-201 1 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 69945-132_23d2a122-df38-4b00-b783-af0ff2e88543 69945-132 HUMAN PRESCRIPTION DRUG INDIUM IN 111 CHLORIDE indium in 111 chloride SOLUTION INTRAVENOUS 20071207 NDA NDA019841 MALLINCKRODT NUCLEAR MEDICINE LLC INDIUM CHLORIDE IN-111 10 mCi/mL N 20181231 69945-140_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-140 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 14 Ci/1 N 20181231 69945-160_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-160 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 16 Ci/1 N 20181231 69945-180_75bc49b1-a7ef-4937-b5ec-180d4e9fc954 69945-180 HUMAN PRESCRIPTION DRUG GALLIUM CITRATE GA-67 gallium citrate ga-67 INJECTION, SOLUTION INTRAVENOUS 20080221 NDA NDA018058 MALLINCKRODT NUCLEAR MEDICINE LLC GALLIUM CHLORIDE GA-67 2 mCi/mL N 20181231 69945-190_563a0d66-f658-4cf2-be49-bfcac6a28be7 69945-190 HUMAN PRESCRIPTION DRUG Ultra-Technekow V4 Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20140610 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 19 Ci/1 N 20181231 69945-450_d70c5437-3152-4393-830b-53c61acfc87c 69945-450 HUMAN PRESCRIPTION DRUG Sodium Iodide I-131 Therapeutic sodium iodide, i-131 SOLUTION ORAL 20151027 NDA NDA016515 MALLINCKRODT NUCLEAR MEDICINE LLC SODIUM IODIDE I-131 5 mCi/mL Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 69945-451_d70c5437-3152-4393-830b-53c61acfc87c 69945-451 HUMAN PRESCRIPTION DRUG Sodium Iodide I-131 Therapeutic sodium iodide, i-131 SOLUTION ORAL 20151027 NDA NDA016515 MALLINCKRODT NUCLEAR MEDICINE LLC SODIUM IODIDE I-131 25 mCi/mL Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 69945-452_63bb1be3-a538-4ac8-8908-880231980efb 69945-452 HUMAN PRESCRIPTION DRUG SODIUM IODIDE I 131 sodium iodide i 131 CAPSULE, GELATIN COATED ORAL 20151027 NDA NDA016517 MALLINCKRODT NUCLEAR MEDICINE LLC SODIUM IODIDE I-131 1 mCi/mL Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 69945-601_6b26fa17-b31e-418f-8d61-44ba97cc513b 69945-601 HUMAN PRESCRIPTION DRUG SODIUM IODIDE I 123 sodium iodide i 123 CAPSULE, GELATIN COATED ORAL 20151104 ANDA ANDA071909 MALLINCKRODT NUCLEAR MEDICINE LLC SODIUM IODIDE I-123 100 uCi/1 N 20181231 69945-602_6b26fa17-b31e-418f-8d61-44ba97cc513b 69945-602 HUMAN PRESCRIPTION DRUG SODIUM IODIDE I 123 sodium iodide i 123 CAPSULE, GELATIN COATED ORAL 20070411 ANDA ANDA071910 MALLINCKRODT NUCLEAR MEDICINE LLC SODIUM IODIDE I-123 200 uCi/1 N 20181231 69945-883_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-883 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 1 Ci/1 N 20181231 69945-884_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-884 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 1.5 Ci/1 N 20181231 69945-885_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-885 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 2 Ci/1 N 20181231 69945-886_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-886 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 2.5 Ci/1 N 20181231 69945-887_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-887 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 3 Ci/1 N 20181231 69945-888_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-888 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 3.5 Ci/1 N 20181231 69945-889_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-889 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 5 Ci/1 N 20181231 69945-890_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-890 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 6 Ci/1 N 20181231 69945-891_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-891 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 7.5 Ci/1 N 20181231 69945-892_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-892 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 11 Ci/1 N 20181231 69945-893_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-893 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 14 Ci/1 N 20181231 69945-894_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-894 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 16 Ci/1 N 20181231 69945-895_c529f390-ac1b-42c2-8b21-8b46089b6b84 69945-895 HUMAN PRESCRIPTION DRUG Ultra-TechneKow DTE Technetium Tc-99m INJECTION, SOLUTION INTRAVENOUS 20151207 NDA NDA017243 MALLINCKRODT NUCLEAR MEDICINE LLC TECHNETIUM TC-99M SODIUM PERTECHNETATE 19 Ci/1 N 20181231 69946-010_dbe462d8-a592-4c72-b340-8d6b1251d2b7 69946-010 HUMAN OTC DRUG BK Cell 5DAYS OF SECRET MYSTIC CLEANSING Glycerin PATCH TOPICAL 20150601 UNAPPROVED DRUG OTHER BNK CO., LTD. GLYCERIN .6 g/20g E 20171231 69946-020_ba430a2a-aefb-41e7-830b-16a759624197 69946-020 HUMAN OTC DRUG BK Cell 5DAYS OF SECRET AQUA MOISTURIZING Glycerin PATCH TOPICAL 20150601 UNAPPROVED DRUG OTHER BNK CO., LTD. GLYCERIN 1.92 mg/32mL E 20171231 69946-030_9d9dd07a-2387-4036-8c81-19556b426ea6 69946-030 HUMAN OTC DRUG BK Cell 5DAYS OF SECRET SNOW WHITENING Niacinamide PATCH TOPICAL 20150601 UNAPPROVED DRUG OTHER BNK CO., LTD. NIACINAMIDE .5 mg/25mL E 20171231 69946-040_227d130f-381c-49da-ab81-2b120468cb83 69946-040 HUMAN OTC DRUG BK Cell 5DAYS OF SECRET PURITY WRINKLE LIFTING Glycerin PATCH TOPICAL 20150601 UNAPPROVED DRUG OTHER BNK CO., LTD. GLYCERIN 1.8 mg/30mL E 20171231 69946-050_d2c06492-10b5-4cf5-aaff-1bc3458b91c2 69946-050 HUMAN OTC DRUG BK Cell 5DAYS OF SECRET LOVE TOTAL ANTI AGING Dimethicone PATCH TOPICAL 20150601 OTC MONOGRAPH FINAL part347 BNK CO., LTD. DIMETHICONE .96 mg/32mL E 20171231 69946-060_a6b1ac3a-fb7f-49ba-b0f7-d4e27471ab6b 69946-060 HUMAN OTC DRUG BK Cell AQUA PERFECT SNAIL Dimethicone CREAM TOPICAL 20150601 OTC MONOGRAPH FINAL part347 BNK CO., LTD. DIMETHICONE .5 g/50g E 20171231 69946-070_4657d922-9b4e-42e1-a1d7-3467915475f8 69946-070 HUMAN OTC DRUG BK Cell 2STEP AQUA TOKTOK MASK Allantoin PATCH TOPICAL 20150801 UNAPPROVED DRUG OTHER BNK CO., LTD. ALLANTOIN .004 g/2.4g E 20171231 69947-120_1edd1548-92e3-0fcc-e054-00144ff88e88 69947-120 HUMAN OTC DRUG Hand Sanitizer Ethanol LIQUID TOPICAL 20150903 OTC MONOGRAPH NOT FINAL part333E Alsco Inc. ALCOHOL 71 mL/100mL N 20181231 69949-293_7b92065f-26a2-401f-b986-d27f5b129bdf 69949-293 HUMAN OTC DRUG Suntegrity Lip CPR Lipstick Sable Shade SPF30 Zinc OXide LIPSTICK TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Synchronicity Spa, Inc dba Suntegrity ZINC OXIDE 18 g/100g N 20181231 69949-294_46d5e285-1777-4e20-ad11-00dfc41e07ec 69949-294 HUMAN OTC DRUG Suntegrity Lip CPR Lipstick Sunburst Pink SPF30 Zinc OXide LIPSTICK TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Synchronicity Spa, Inc dba Suntegrity ZINC OXIDE 18 g/100g N 20181231 69949-295_d31660e6-d6a4-4337-b26c-c99fabf96a6b 69949-295 HUMAN OTC DRUG Suntegrity Lip CPR Lipstick Plum Eclipse SPF30 Zinc OXide LIPSTICK TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Synchronicity Spa, Inc dba Suntegrity ZINC OXIDE 18 g/100g N 20181231 69949-296_73f9664b-894e-4941-bfbf-cc25c4cc9e2f 69949-296 HUMAN OTC DRUG Suntegrity Lip CPR Lipstick Sunset Coral SPF30 Zinc Oxide LIPSTICK TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Synchronicity Spa, Inc dba Suntegrity ZINC OXIDE 18 g/100g N 20181231 69949-297_6f01e20e-4352-4c38-a6a0-67ff19896916 69949-297 HUMAN OTC DRUG Suntegrity Lip CPR Lipstick Sunburst Pink SPF30 Zinc OXide LIPSTICK TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Synchronicity Spa, Inc dba Suntegrity ZINC OXIDE 18 g/100g N 20181231 69949-298_98480f36-b9af-4e41-9c9e-6017fb36a58a 69949-298 HUMAN OTC DRUG Suntegrity Lip CPR Lipstick Fuchsia Flare SPF30 Zinc OXide LIPSTICK TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Synchronicity Spa, Inc dba Suntegrity ZINC OXIDE 18 g/100g N 20181231 69949-299_55cac1b0-4fc3-49b0-9afe-aa94afdc7838 69949-299 HUMAN OTC DRUG Suntegrity Lip CPR Lipstick Sunny Blush SPF30 Zinc OXide LIPSTICK TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Synchronicity Spa, Inc dba Suntegrity ZINC OXIDE 18 g/100g N 20181231 69949-300_66a194d7-62b0-49a7-8db1-96c9fdadba14 69949-300 HUMAN OTC DRUG Suntegrity Lip CPR Lipstick Sunrise Peach SPF30 Zinc OXide LIPSTICK TOPICAL 20151215 OTC MONOGRAPH NOT FINAL part352 Synchronicity Spa, Inc dba Suntegrity ZINC OXIDE 18 g/100g N 20181231 69949-331_39993baf-4dd0-49e6-bf20-6d0438fd2fec 69949-331 HUMAN OTC DRUG Suntegrity Lip CPR Lipstick Stargazer Bloom SPF30 Zinc Oxide LIPSTICK TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Synchronicity Spa, Inc dba Suntegrity ZINC OXIDE 18 g/100g N 20181231 69949-338_190d4f0a-6dbf-4e94-a5f0-f67d26c6acfc 69949-338 HUMAN OTC DRUG Suntegrity Lip CPR Lipstick Moonlight Merlot SPF30 Zinc OXide LIPSTICK TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Synchronicity Spa, Inc dba Suntegrity ZINC OXIDE 18 g/100g N 20181231 69950-001_7ebf32d6-3115-46f4-9b5b-0674b224b1fc 69950-001 HUMAN OTC DRUG maxim 70% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID TOPICAL 20150720 OTC MONOGRAPH NOT FINAL part333A OSTL, INC. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 69950-001_850e7819-ae42-4a90-b761-175de6e18f71 69950-001 HUMAN OTC DRUG maxim 70% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID TOPICAL 20160517 OTC MONOGRAPH NOT FINAL part333A OSTL, INC. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 69950-002_f048b0c0-3a95-49cb-9330-21c6162fdeba 69950-002 HUMAN OTC DRUG maxim 70% ISOPROPYL RUBBING ALCOHOL With Wintergreen ISOPROPYL ALCOHOL LIQUID TOPICAL 20150720 OTC MONOGRAPH NOT FINAL part333A OSTL, INC. ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 69950-003_16378eee-be45-4147-84bf-b9145b60e97b 69950-003 HUMAN OTC DRUG maxim 50% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID TOPICAL 20150720 OTC MONOGRAPH NOT FINAL part333A OSTL, INC. ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 69950-003_9bee1c3b-1fe9-4d1d-9612-2c27f903e07a 69950-003 HUMAN OTC DRUG maxim 50% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID TOPICAL 20160517 OTC MONOGRAPH NOT FINAL part333A OSTL, INC. ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 69950-004_9bcd66d0-a268-4756-a43d-570ddf8fa7e8 69950-004 HUMAN OTC DRUG maxim 50% ISOPROPYL RUBBING ALCOHOL With Wintergreen ISOPROPYL ALCOHOL LIQUID TOPICAL 20150720 OTC MONOGRAPH NOT FINAL part333A OSTL, INC. ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 69950-005_8e64279b-e16d-40d6-9cdd-bf59aebcce6e 69950-005 HUMAN OTC DRUG maxim Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part333A Ostl, Inc. HYDROGEN PEROXIDE 30 mg/mL N 20181231 69950-005_cf365a61-6e9c-4ee5-af82-41eb0e218f3c 69950-005 HUMAN OTC DRUG maxim Hydrogen Peroxide Hydrogen Peroxide LIQUID TOPICAL 20160517 OTC MONOGRAPH NOT FINAL part333A Ostl, Inc. HYDROGEN PEROXIDE 30 mg/mL N 20181231 69950-010_a25e11f6-bbc4-418d-99a2-dcf3a0347d8e 69950-010 HUMAN OTC DRUG adriana Gold Antibacterial Hand Soap Chloroxylenol LIQUID TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part333E OSTL, INC. CHLOROXYLENOL .3 g/100mL N 20191231 69950-020_647143e0-2437-9ce2-e053-2991aa0a3aac 69950-020 HUMAN OTC DRUG ADRIANA CLIP ON HAND SANITIZER ALCOHOL GEL TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part333E OSTL, INC. ALCOHOL 62 mL/100mL N 20191231 69950-021_6483c082-59ab-594d-e053-2991aa0a5161 69950-021 HUMAN OTC DRUG ADRIANA 8OZ HAND SANITIZER -ORIGINAL ALCOHOL GEL TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part333E OSTL, INC. ALCOHOL 62 mL/100mL N 20191231 69950-022_6483de44-cf9e-80d5-e053-2a91aa0a78f0 69950-022 HUMAN OTC DRUG ADRIANA 8OZ HAND SANITIZER - ALOE VERA ALCOHOL GEL TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part333E OSTL, INC. ALCOHOL 62 mL/100mL N 20191231 69950-023_64842c5a-54fa-857e-e053-2a91aa0af2f1 69950-023 HUMAN OTC DRUG ADRIANA 12OZ HAND SANITIZER ALCOHOL GEL TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part333E OSTL, INC. ALCOHOL 62 mL/100mL N 20191231 69951-001_1ec9ed1c-bcb7-3a0a-e054-00144ff8d46c 69951-001 HUMAN OTC DRUG Prevention Oncology Mouth Rinse Glycerin LIQUID ORAL 20150902 OTC MONOGRAPH NOT FINAL part356 Prevention Health Sciences, Inc. GLYCERIN 4.5 mg/100mL N 20181231 69953-514_3711f772-720a-5e29-e054-00144ff8d46c 69953-514 HUMAN OTC DRUG Morning After Levonorgestrel TABLET ORAL 20160821 ANDA ANDA202334 Rapha Pharmaceuticals, Inc. LEVONORGESTREL 1.5 mg/1.5mg N 20181231 69958-010_a3da8b31-9fca-4422-8d03-cd9c0a1779e7 69958-010 HUMAN OTC DRUG FOUNDATION NUDE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE LIQUID TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 J2D INTERNATIONAL TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.9; 1.85; .37 g/37g; g/37g; g/37g N 20181231 69958-020_e02c71c5-9103-4651-a1b5-2c62651b3d0e 69958-020 HUMAN OTC DRUG FOUNDATION SWEET ALMOND TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE LIQUID TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 J2D INTERNATIONAL TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.9; 1.85; .37 g/37g; g/37g; g/37g N 20181231 69958-030_aecb306d-e594-4732-95cb-f33dbde4c282 69958-030 HUMAN OTC DRUG FOUNDATION CARAMEL TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE LIQUID TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 J2D INTERNATIONAL TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.9; 1.85; .37 g/37g; g/37g; g/37g N 20181231 69958-040_1790d6d4-c236-420f-9dbb-7a03219fbc57 69958-040 HUMAN OTC DRUG FOUNDATION SOFT COCOA TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE LIQUID TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 J2D INTERNATIONAL TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.9; 1.85; .37 g/37g; g/37g; g/37g N 20181231 69958-050_dd1967e9-7459-4140-ad30-83f2d7881662 69958-050 HUMAN OTC DRUG CAMOUFLAGE CONCEALER NUDE Titanium Dioxide POWDER TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 J2D INTERNATIONAL TITANIUM DIOXIDE .98 g/5g N 20181231 69958-060_d62ea755-aaab-426c-9466-4e5f3fa186a8 69958-060 HUMAN OTC DRUG CAMOUFLAGE CONCEALER SWEET ALMOND Titanium Dioxide POWDER TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 J2D INTERNATIONAL TITANIUM DIOXIDE .67 g/5g N 20181231 69958-070_449f6da4-0f38-480f-8292-36c7f60c8bde 69958-070 HUMAN OTC DRUG CAMOUFLAGE CONCEALER CARAMEL Titanium Dioxide POWDER TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 J2D INTERNATIONAL TITANIUM DIOXIDE .89 g/5g N 20181231 69958-080_5f16c09d-994d-4834-aed7-830191d30058 69958-080 HUMAN OTC DRUG CAMOUFLAGE CONCEALER SOFT COCOA Titanium Dioxide POWDER TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 J2D INTERNATIONAL TITANIUM DIOXIDE .55 g/5g N 20181231 69958-090_eee79c49-a582-4ecd-b66b-7c8b87fd4eda 69958-090 HUMAN OTC DRUG CAMOUFLAGE CONCEALER WARM MOCHA Titanium Dioxide POWDER TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 J2D INTERNATIONAL TITANIUM DIOXIDE .28 g/5g N 20181231 69958-100_4cb15edd-d2f8-4a9a-8757-825b750d8839 69958-100 HUMAN OTC DRUG PERFECT SKIN PACT SWEET ALMOND Titanium Dioxide POWDER TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 J2D INTERNATIONAL TITANIUM DIOXIDE 2.06 g/12g N 20181231 69958-110_644dc914-e012-42f5-a2f2-fbe49bd4ff3b 69958-110 HUMAN OTC DRUG PERFECT SKIN PACT CARAMEL Titanium Dioxide POWDER TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 J2D INTERNATIONAL TITANIUM DIOXIDE 2.06 g/12g N 20181231 69958-120_7e0a7eaa-efb6-41b6-9080-aa00d57511a7 69958-120 HUMAN OTC DRUG CRE AM2ATE Queen Snow Lotus Niacinamide, Adenosine CREAM TOPICAL 20170901 UNAPPROVED DRUG OTHER J2D INTERNATIONAL NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 69958-130_43f14f5e-aa40-44c9-9149-71776e64ea29 69958-130 HUMAN OTC DRUG CRE AM2ATE Knight Seahorse Niacinamide, Adenosine CREAM TOPICAL 20170901 UNAPPROVED DRUG OTHER J2D INTERNATIONAL NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 69961-010_b89832ed-96ac-46ca-bc87-a31bdb43a38f 69961-010 HUMAN OTC DRUG BARAMO STYPHNOLOBIUM JAPONICUM FLOWER BUD SHAMPOO TOPICAL 20150601 UNAPPROVED DRUG OTHER Mentor Lab STYPHNOLOBIUM JAPONICUM FLOWER BUD .3 mg/300mL N 20181231 69961-020_4603c1ef-bf2f-42e8-9b25-92c1abdfe0f5 69961-020 HUMAN OTC DRUG BARAMO SCALP SERUM STYPHNOLOBIUM JAPONICUM FLOWER BUD SOLUTION TOPICAL 20150601 UNAPPROVED DRUG OTHER Mentor Lab STYPHNOLOBIUM JAPONICUM FLOWER BUD .07 mg/70mL N 20181231 69961-030_52584327-5849-44bb-bfaf-d4ad0bbaa68c 69961-030 HUMAN OTC DRUG BARAMO for Normal Scalp STYPHNOLOBIUM JAPONICUM FLOWER BUD SHAMPOO TOPICAL 20161001 UNAPPROVED DRUG OTHER Mentor Lab STYPHNOLOBIUM JAPONICUM FLOWER BUD .1 g/300mL N 20181231 69961-040_29b34f15-4374-4517-871e-c356dc79578e 69961-040 HUMAN OTC DRUG BARAMO for O ily Scalp STYPHNOLOBIUM JAPONICUM FLOWER BUD SHAMPOO TOPICAL 20161001 UNAPPROVED DRUG OTHER Mentor Lab STYPHNOLOBIUM JAPONICUM FLOWER BUD .1 g/300mL N 20181231 69961-050_60781048-361e-45e5-b085-454d94975927 69961-050 HUMAN OTC DRUG BARAMO Scalp Serum for Normal Scalp STYPHNOLOBIUM JAPONICUM FLOWER BUD SOLUTION TOPICAL 20161001 UNAPPROVED DRUG OTHER Mentor Lab STYPHNOLOBIUM JAPONICUM FLOWER BUD .03 g/70mL N 20181231 69961-060_32a9977c-1c8a-4fd4-a43d-b9b715d87f95 69961-060 HUMAN OTC DRUG BARAMO Scalp Serum for O ily Scalp STYPHNOLOBIUM JAPONICUM FLOWER BUD SOLUTION TOPICAL 20161001 UNAPPROVED DRUG OTHER Mentor Lab STYPHNOLOBIUM JAPONICUM FLOWER BUD .03 g/70mL N 20181231 69962-010_fa44f6ec-64a7-420d-8d0b-c5ca91c17b9c 69962-010 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride GEL DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69962-011_dc56f43f-df61-4ffb-afa6-4a17d274116f 69962-011 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride GEL DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69962-012_2caa85bd-0498-4d0d-86da-bda146cb55aa 69962-012 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride GEL DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69962-013_53bab103-70c6-43db-bbf1-4dd6636feefc 69962-013 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride GEL DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69962-014_61eee3de-2569-40e0-bab8-33e9e1994dcd 69962-014 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride GEL DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69962-015_0a0ef141-fe6c-4dc1-aaf8-8b7a9879b783 69962-015 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride GEL DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69962-016_5c32cb59-2166-410c-9fe7-72d67e29e978 69962-016 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride GEL DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69962-017_ad8150cf-968e-4948-980c-d28249fd000a 69962-017 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride GEL DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69962-018_7ca2d3e0-6656-427a-99bc-484fe1e4087e 69962-018 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride GEL DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69962-019_0bdf75d2-8342-401f-8714-21f1ded4896a 69962-019 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride GEL DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 5.6 g/454g N 20181231 69962-020_30c61365-3693-4c64-9eec-a38bba83bdaa 69962-020 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 1.5375 g/125g E 20171231 69962-021_53267cd3-7420-48ca-84e2-2da318fde96e 69962-021 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 1.5375 g/125g E 20171231 69962-022_f3b02267-7ad6-4365-a36e-ccd1cff1fb74 69962-022 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 1.5375 g/125g E 20171231 69962-023_8182acc1-472c-43bd-bb07-8f5c33893e24 69962-023 HUMAN PRESCRIPTION DRUG FIDELIS APF Sodium Fluoride AEROSOL, FOAM DENTAL 20140101 UNAPPROVED DRUG OTHER Webco Dental & Medical Supplies, Inc. SODIUM FLUORIDE 1.5375 g/125g E 20171231 69962-024_b3e09635-359f-4270-bde1-4ffde543b9a7 69962-024 HUMAN OTC DRUG FIDELIS Topical Anesthetic Benzocaine GEL DENTAL 20140101 OTC MONOGRAPH NOT FINAL part356 Webco Dental & Medical Supplies, Inc. BENZOCAINE 200 mg/g N 20181231 69962-025_0cbbc44f-2150-4d19-8e2c-e12fad3619ee 69962-025 HUMAN OTC DRUG FIDELIS Topical Anesthetic Benzocaine GEL DENTAL 20140101 OTC MONOGRAPH NOT FINAL part356 Webco Dental & Medical Supplies, Inc. BENZOCAINE 200 mg/g N 20181231 69962-026_dca1c629-9149-4b39-aa1d-eb65ae25a768 69962-026 HUMAN OTC DRUG FIDELIS Topical Anesthetic Benzocaine GEL DENTAL 20140101 OTC MONOGRAPH NOT FINAL part356 Webco Dental & Medical Supplies, Inc. BENZOCAINE 200 mg/g N 20181231 69962-027_e52129c4-fcea-4a08-b24d-62881233f827 69962-027 HUMAN OTC DRUG FIDELIS Topical Anesthetic Benzocaine GEL DENTAL 20140101 OTC MONOGRAPH NOT FINAL part356 Webco Dental & Medical Supplies, Inc. BENZOCAINE 200 mg/g N 20181231 69962-028_03a15371-4c7b-435d-818b-fbd276a21798 69962-028 HUMAN OTC DRUG FIDELIS Topical Anesthetic Benzocaine GEL DENTAL 20140101 OTC MONOGRAPH NOT FINAL part356 Webco Dental & Medical Supplies, Inc. BENZOCAINE 200 mg/g N 20181231 69962-029_f5136fce-9bb8-4214-8f07-9ef7174508d6 69962-029 HUMAN OTC DRUG FIDELIS Topical Anesthetic Benzocaine GEL DENTAL 20140101 OTC MONOGRAPH NOT FINAL part356 Webco Dental & Medical Supplies, Inc. BENZOCAINE 200 mg/g N 20181231 69962-030_16f52c73-ef75-403f-970f-cc0035ea0895 69962-030 HUMAN OTC DRUG FIDELIS Topical Anesthetic Benzocaine GEL DENTAL 20140101 OTC MONOGRAPH NOT FINAL part356 Webco Dental & Medical Supplies, Inc. BENZOCAINE 200 mg/g N 20181231 69962-031_63ade290-31f6-42b5-9441-501ce68c7684 69962-031 HUMAN OTC DRUG FIDELIS Topical Anesthetic Benzocaine GEL DENTAL 20140101 OTC MONOGRAPH NOT FINAL part356 Webco Dental & Medical Supplies, Inc. BENZOCAINE 200 mg/g N 20181231 69962-032_cff4135b-84ec-4ae4-8ca9-97e8465d6c86 69962-032 HUMAN OTC DRUG FIDELIS Topical Anesthetic Benzocaine GEL DENTAL 20140101 OTC MONOGRAPH NOT FINAL part356 Webco Dental & Medical Supplies, Inc. BENZOCAINE 200 mg/g N 20181231 69963-001_62180579-6f87-6a2c-e053-2a91aa0aa2ec 69963-001 HUMAN OTC DRUG pain relief patch Menthol,Capsaicin,Menthyl salicylate PATCH TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part348 Hangzhou Jujiu Science & Biotechnology Co.,Ltd. MENTHOL; MENTHYL SALICYLATE, (+/-)-; CAPSAICIN 5; 5; .025 g/100g; g/100g; g/100g N 20191231 69965-8111_a4f26983-930e-4ce3-af32-d549dec73151 69965-8111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20150710 OTC MONOGRAPH NOT FINAL part333E Air Techniques ALCOHOL 700 mg/1000mL N 20181231 69967-002_a4c87469-ea20-4440-8810-be5a7bbac747 69967-002 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20150911 OTC MONOGRAPH NOT FINAL part333A ARISE PHARMACEUTICALS LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 69968-0001_33f11f3f-0411-44bc-bece-a768679046b5 69968-0001 HUMAN OTC DRUG Aveeno Skin Relief Gentle Scent Soothing Oat and Chamomile Dimethicone LOTION TOPICAL 20150801 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 13 mg/mL N 20181231 69968-0002_2db8c885-18b3-407d-983b-fb706ff0559c 69968-0002 HUMAN OTC DRUG Aveeno Skin Relief Gentle Scent Nourishing Coconut Dimethicone LOTION TOPICAL 20150801 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 13 mg/mL N 20181231 69968-0003_34e0e18d-122a-4efa-9bf1-eaabfbe6da76 69968-0003 HUMAN OTC DRUG Aveeno Active Naturals Daily Moisturizing Dimethicone LOTION TOPICAL 20040201 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 12 mg/mL N 20181231 69968-0006_968e9528-024d-4fc8-8eb2-d2b84f7ef9fa 69968-0006 HUMAN OTC DRUG Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27; 80; 50; 35; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0007_4daba84f-c580-447f-b29e-b5e5d3627198 69968-0007 HUMAN OTC DRUG Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 45; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0008_edf7f617-b6ea-4c23-b29a-88b3840f431f 69968-0008 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0009_5d17114d-a35e-4755-aae8-0a4c18fe404f 69968-0009 HUMAN OTC DRUG Neutrogena Clear Face Break Out Free Sunscreen Broad Spectrum SPF55 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27; 40; 45; 60; 45 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0010_ddaa53da-9d51-415b-acfe-893b8c1c2935 69968-0010 HUMAN OTC DRUG Neutrogena Clear Face Break Out Free Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20110901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 25; 50; 40; 30; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0011_83a343dd-9b0d-428b-9629-f7551660e0c1 69968-0011 HUMAN OTC DRUG Clean and Clear acne triple clear cleanser Salicylic Acid GEL TOPICAL 20161015 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/g N 20181231 69968-0012_1b739b1a-8e9e-472b-b65c-e84bc1e0c341 69968-0012 HUMAN OTC DRUG Clean and Clear acne triple clear bubble foam cleanser Salicylic Acid SOLUTION TOPICAL 20161101 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0013_286ce77b-fa93-44e4-ac7f-acd9f50d9ce3 69968-0013 HUMAN OTC DRUG Clean and Clear acne triple clear exfoliating scrub Salicylic Acid GEL TOPICAL 20161101 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/g N 20181231 69968-0017_0f27c1d2-c351-4e86-b7d4-833fb3122af7 69968-0017 HUMAN OTC DRUG Neutrogena Rapid Wrinkle Repair Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120613 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0018_0f2b13ce-581a-41da-86ef-81f5ad646fe5 69968-0018 HUMAN OTC DRUG Neutrogena Rapid Tone Repair Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0019_126cab54-0a59-48be-8d11-25ca1a5aec42 69968-0019 HUMAN OTC DRUG Neutrogena naturals Brightening Daily Moisturizer Broad Spectrum SPF 25 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20160601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE; ZINC OXIDE 41; 3 mg/mL; mg/mL N 20181231 69968-0020_bb56ecf2-1ec4-4206-b708-88378a829922 69968-0020 HUMAN OTC DRUG Aveeno Baby Eczema Therapy Nighttime Balm Oatmeal CREAM TOPICAL 20160601 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 10 mg/g N 20181231 69968-0021_cf867718-ad5b-4959-af53-fa8ee7e65bc8 69968-0021 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20070205 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 23.5; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0022_7d4ba42f-efed-4058-9eda-356c45d53f90 69968-0022 HUMAN OTC DRUG Bengay Greaseless Pain Relieving Menthol, Unspecified Form and Methyl Salicylate CREAM TOPICAL 20131215 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 100; 150 mg/g; mg/g N 20181231 69968-0023_4b4e5d8a-fefe-4141-bb05-734eeb2d042a 69968-0023 HUMAN OTC DRUG Visine ALL DAY COMFORT DRY EYE Relief Glycerin, Hypromelloses, and Polyethylene Glycol 400 SOLUTION/ DROPS OPHTHALMIC 20151201 OTC MONOGRAPH FINAL part349 Johnson & Johnson Consumer Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 3.6; 10 mg/mL; mg/mL; mg/mL N 20181231 69968-0024_08ca5c87-c347-45df-8188-b13974fde3c6 69968-0024 HUMAN OTC DRUG Visine Tired Eye Dry Eye Relief Glycerin, Hypromelloses, and Polyethylene Glycol 400 SOLUTION/ DROPS OPHTHALMIC 20160205 OTC MONOGRAPH FINAL part349 Johnson & Johnson Consumer Inc. GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400 2; 3.6; 10 mg/mL; mg/mL; mg/mL N 20181231 69968-0026_8aae0c5a-51cf-4d58-bcfc-8e16d2518b81 69968-0026 HUMAN OTC DRUG Neutrogena Clear Pore Cleanser Mask Benzoyl Peroxide GEL TOPICAL 20160401 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 35 mg/mL N 20181231 69968-0027_ade58bb3-0501-43d1-885b-07159edab50e 69968-0027 HUMAN OTC DRUG Neutrogena Clear Pore Daily Scrub Benzoyl Peroxide SUSPENSION TOPICAL 20151207 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 37 mg/mL N 20181231 69968-0029_9e428fe2-7022-4929-9caf-41c3d55e6d53 69968-0029 HUMAN OTC DRUG Neutrogena Hydro Boost Water Sunscreen Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, and Octocrylene GEL TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2; 4; 4; 2 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0030_4619d0e3-0c5f-4fbe-928a-7fcebfa97aa2 69968-0030 HUMAN OTC DRUG Womens Rogaine Unscented Minoxidil AEROSOL, FOAM TOPICAL 20110401 NDA NDA021812 Johnson & Johnson Consumer Inc. MINOXIDIL 50 mg/g N 20181231 69968-0031_ab36b844-19de-4340-b32b-5e3abdaa5895 69968-0031 HUMAN OTC DRUG Mens rogaine Minoxidil - Unscented Formula Minoxidil AEROSOL, FOAM TOPICAL 20101001 NDA NDA021812 Johnson & Johnson Consumer Inc. MINOXIDIL 50 mg/g N 20181231 69968-0032_68c6f328-5894-415d-aed0-f002fea7a7e1 69968-0032 HUMAN OTC DRUG Clean and Clear Advantage Fast Acting Treatment Benzoyl Peroxide GEL TOPICAL 20151001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 25 mg/g N 20181231 69968-0033_8cc85e67-90f8-4c0c-969f-c33e3dbf37e2 69968-0033 HUMAN OTC DRUG Clean and Clear Advantage Acne Control Cleanser Benzoyl Peroxide CREAM TOPICAL 20151001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 50 mg/g N 20181231 69968-0034_039da4d4-540d-4c80-b3f4-bfe28225d772 69968-0034 HUMAN OTC DRUG Clean and Clear Advantage Acne Control Benzoyl Peroxide KIT 20151105 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. N 20181231 69968-0035_4c944687-cb35-4b62-b31f-019d597ed685 69968-0035 HUMAN OTC DRUG Aveeno Active Naturals Eczema Therapy Itch Relief Balm Oatmeal CREAM TOPICAL 20160901 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 10 mg/g N 20181231 69968-0036_7c426bc1-6f68-433c-abf6-5fd0cf6bcbaf 69968-0036 HUMAN OTC DRUG Aveeno Baby Eczema Therapy Moisturizing Oatmeal CREAM TOPICAL 20100601 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 10 mg/g N 20181231 69968-0038_6b512e10-b684-4c20-8f70-d42c43c2dac7 69968-0038 HUMAN OTC DRUG Aveeno Baby Calming Comfort Dimethicone LOTION TOPICAL 20020601 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 12 mg/mL N 20181231 69968-0039_f9b3a2d8-e97f-45ce-a865-d6f8c983caa1 69968-0039 HUMAN OTC DRUG Aveeno Baby Daily Moisture Dimethicone LOTION TOPICAL 20010801 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 12 mg/mL N 20181231 69968-0041_b4dc24df-8fc4-44dd-9bc6-7e812b6f8d42 69968-0041 HUMAN OTC DRUG Aveeno Absolutely Ageless Daily Moisturizer Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0042_463b1170-3f9d-4cbb-8876-0a8ca8ae0f37 69968-0042 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Pink Grapefruit Facial Cleanser Salicylic Acid LIQUID TOPICAL 20080601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0043_f89c00e0-5567-4f77-8665-944d44c042ed 69968-0043 HUMAN OTC DRUG Neutrogena Rapid Clear Stubborn Acne Spot Benzoyl Peroxide GEL TOPICAL 20140905 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 100 mg/g N 20181231 69968-0044_3d64733f-aeb6-416e-93ca-3cf9bd41f422 69968-0044 HUMAN OTC DRUG Clean and Clear Daily Skincare Essentials Salicylic Acid KIT 20150920 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. N 20181231 69968-0045_79bde53f-7b36-4d68-a2a1-668a31ea39c2 69968-0045 HUMAN OTC DRUG Neutrogena Oil Free Acne Correct and Cover Pink Grapefruit Moisturizer Fair to Light Salicylic Acid LOTION TOPICAL 20151001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 69968-0046_b1ac63ee-cfa8-4a55-835c-6ec8500ada59 69968-0046 HUMAN OTC DRUG Neutrogena Oil Free Acne Correct and Cover Pink Grapefruit Moisturizer Medium to Tan Salicylic Acid LOTION TOPICAL 20151001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 69968-0047_fc37d28b-eef8-4ef2-a5e4-8bb550401dfa 69968-0047 HUMAN OTC DRUG Aveeno ACTIVE NATURALS protect Plus hydrate sunscreen BROAD SPECTRUM SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20151207 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0048_3d2af867-e3ea-4719-aef7-a65e3da1d12e 69968-0048 HUMAN OTC DRUG Aveeno Active Naturals Protect Plus Hydrate Sunscreen Broad Spectrum SPF50 for face Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20120912 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 60; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0049_493b8544-02b5-4a88-ac3c-90483deecb40 69968-0049 HUMAN OTC DRUG Aveeno Active Naturals Protect Plus Hydrate Sunscreen Broad Spectrum SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20120901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0055_1a6f5834-24ed-4043-b516-51a7d1b79931 69968-0055 HUMAN OTC DRUG Neosporin Plus Pain Relief First Aid Antibiotic/Pain Relieving Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride CREAM TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g N 20181231 69968-0057_377165ba-a685-4976-acba-5a32458beb04 69968-0057 HUMAN OTC DRUG Neosporin Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/g N 20181231 69968-0058_72c5f9ab-89d2-4689-a3a1-5ee2171d67fd 69968-0058 HUMAN OTC DRUG Bengay Cold Therapy Menthol, Unspecified Form GEL TOPICAL 20101025 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. MENTHOL, UNSPECIFIED FORM 50 mg/g N 20181231 69968-0060_da57b288-188b-43bc-a3b9-e80a98cd6f61 69968-0060 HUMAN OTC DRUG Polysporin First Aid Antibiotic Bacitracin Zinc and Polymyxin B Sulfate OINTMENT TOPICAL 20130709 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Inc. BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 69968-0061_0256e9eb-8f5a-43f3-869b-e920a16b4999 69968-0061 HUMAN OTC DRUG Desitin Maximum Strength Diaper Rash Zinc Oxide PASTE TOPICAL 20151116 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. ZINC OXIDE 400 mg/g N 20191231 69968-0063_11baf4ee-a88f-46ff-8749-40f6f858475c 69968-0063 HUMAN OTC DRUG Visine A Multi-Action Eye Allergy Relief Naphazoline Hydrochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20101215 NDA NDA020485 Johnson & Johnson Consumer Inc. NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL N 20181231 69968-0065_ac76aeb8-173c-4c62-b356-73567a5973ad 69968-0065 HUMAN OTC DRUG Aveeno Active Naturals Eczema Therapy Moisturizing Oatmeal CREAM TOPICAL 20130401 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 10 mg/g N 20181231 69968-0066_e721086e-9049-4e8d-9a66-e709db0fa102 69968-0066 HUMAN OTC DRUG Aveeno Active Naturals Eczema Therapy Hand Oatmeal CREAM TOPICAL 20140501 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 10 mg/g N 20181231 69968-0068_c357c71b-7e20-4e5e-8039-0fd13b9064bd 69968-0068 HUMAN OTC DRUG Neutrogena CoolDry Sport Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0069_820a2603-45c7-4e82-a84f-2edd5fc22060 69968-0069 HUMAN OTC DRUG Neutrogena CoolDry Sport Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0070_52325556-28c9-4b8c-8bb9-4bb0a84002c5 69968-0070 HUMAN OTC DRUG Neutrogena CoolDry Sport Sunscreen Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27; 90; 45; 60; 45 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0071_63107e6d-aeb3-48fa-b112-d2728c3c05fd 69968-0071 HUMAN OTC DRUG Neutrogena Body Clear Body Wash - Pink Grapefruit Salicylic Acid SUSPENSION TOPICAL 20151013 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0073_a0079951-e37a-4c1f-bad9-14fff67d1bd0 69968-0073 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control Power Clear Scrub Salicylic Acid GEL TOPICAL 20161101 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0074_14d6ef35-daaa-4813-858f-2a20ea7ed235 69968-0074 HUMAN OTC DRUG Neutrogena Complete Acne Therapy Solution Salicylic Acid, Avobenzone, Octisalate, Octocrylene, Oxybenzone, and Benzoyl Peroxide KIT 20161001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. N 20181231 69968-0075_c3a162e5-d5ad-44bd-9d81-3d6b7a1683fb 69968-0075 HUMAN OTC DRUG Neutrogena Oil-Free Acne Wash Daily Scrub Salicylic acid GEL TOPICAL 20160601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0076_25c0a161-2995-4086-88fc-bfedae3d03ea 69968-0076 HUMAN OTC DRUG Neutrogena Healthy Skin Anti-Aging Perfector Sunscreen Broad Spectrum SPF 20 Ivory to Fair 10 Octinoxate and Octisalate LOTION TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OCTISALATE 70; 30 mg/mL; mg/mL N 20181231 69968-0077_25c0a161-2995-4086-88fc-bfedae3d03ea 69968-0077 HUMAN OTC DRUG Neutrogena Healthy Skin Anti-Aging Perfector Sunscreen Broad Spectrum SPF 20 Fair to Light 20 Octinoxate and Octisalate LOTION TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OCTISALATE 70; 30 mg/mL; mg/mL N 20181231 69968-0078_25c0a161-2995-4086-88fc-bfedae3d03ea 69968-0078 HUMAN OTC DRUG Neutrogena Healthy Skin Anti-Aging Perfector Sunscreen Broad Spectrum SPF 20 Light to Neutral 30 Octinoxate and Octisalate LOTION TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OCTISALATE 70; 30 mg/mL; mg/mL N 20181231 69968-0079_25c0a161-2995-4086-88fc-bfedae3d03ea 69968-0079 HUMAN OTC DRUG Neutrogena Healthy Skin Anti-Aging Perfector Sunscreen Broad Spectrum SPF 20 Neutral to Tan 40 Octinoxate and Octisalate LOTION TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OCTISALATE 70; 30 mg/mL; mg/mL N 20181231 69968-0080_25c0a161-2995-4086-88fc-bfedae3d03ea 69968-0080 HUMAN OTC DRUG Neutrogena Healthy Skin Anti-Aging Perfector Sunscreen Broad Spectrum SPF 20 Tan to Medium 50 Octinoxate and Octisalate LOTION TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OCTISALATE 70; 30 mg/mL; mg/mL N 20181231 69968-0081_25c0a161-2995-4086-88fc-bfedae3d03ea 69968-0081 HUMAN OTC DRUG Neutrogena Healthy Skin Anti-Aging Perfector Sunscreen Broad Spectrum SPF 20 Medium to Deep 60 Octinoxate and Octisalate LOTION TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OCTISALATE 70; 30 mg/mL; mg/mL N 20181231 69968-0082_3a697d0d-70fd-46e3-a67a-fdfd943f77c5 69968-0082 HUMAN OTC DRUG Neutrogena Healthy Skin Glow Sheers Illuminating Tinted Moisturizer - Light to Medium 30 Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LIQUID TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 75; 50; 40; 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0083_3a697d0d-70fd-46e3-a67a-fdfd943f77c5 69968-0083 HUMAN OTC DRUG Neutrogena Healthy Skin Glow Sheers Illuminating Tinted Moisturizer - Fair to Light 20 Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LIQUID TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 75; 50; 40; 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0085_f1126ba0-d9fe-4742-ab15-5858ea19dcab 69968-0085 HUMAN OTC DRUG Neutrogena Healthy Skin 3 in 1 Concealer for Eyes Sunscreen Broad Spectrum SPF20 - Buff Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 95 mg/g N 20181231 69968-0086_f1126ba0-d9fe-4742-ab15-5858ea19dcab 69968-0086 HUMAN OTC DRUG Neutrogena Healthy Skin 3 in 1 Concealer for Eyes Sunscreen Broad Spectrum SPF20 - Medium Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 95 mg/g N 20181231 69968-0087_f1126ba0-d9fe-4742-ab15-5858ea19dcab 69968-0087 HUMAN OTC DRUG Neutrogena Healthy Skin 3 in 1 Concealer for Eyes Sunscreen Broad Spectrum SPF20 - Light Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 95 mg/g N 20181231 69968-0088_f1126ba0-d9fe-4742-ab15-5858ea19dcab 69968-0088 HUMAN OTC DRUG Neutrogena Healthy Skin 3 in 1 Concealer for Eyes Sunscreen Broad Spectrum SPF20 - Fair Titanium Dioxide CREAM TOPICAL 20130524 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 95 mg/g N 20181231 69968-0089_9b07805f-cec0-4c9d-92ce-499b25f89c0f 69968-0089 HUMAN OTC DRUG Mens Rogaine Extra Strength Unscented Minoxidil SOLUTION TOPICAL 20100716 NDA NDA020834 Johnson & Johnson Consumer Inc. MINOXIDIL 50 mg/mL N 20181231 69968-0090_9474298e-9c69-490e-98a5-46b0f4e69b83 69968-0090 HUMAN OTC DRUG Womens Rogaine Unscented Minoxidil SOLUTION TOPICAL 20100801 NDA NDA019501 Johnson & Johnson Consumer Inc. MINOXIDIL 20 mg/mL N 20181231 69968-0091_90993803-9391-4b60-8197-4d48387f3f3b 69968-0091 HUMAN OTC DRUG Neutrogena Wet Skin Kids Sunscreen Broad Spectrum SPF70 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0092_fb1e8563-1ab7-4687-8d0b-151cb522e3f3 69968-0092 HUMAN OTC DRUG Neutrogena All in 1 Acne Control Daily Scrub Salicylic Acid LIQUID TOPICAL 20160601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0093_4cbf6aec-e961-4f5d-99cd-bd2ca6f0ccda 69968-0093 HUMAN OTC DRUG Neosporin Pain Itch Scar Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride OINTMENT TOPICAL 20160115 OTC MONOGRAPH FINAL part333B Johnson & Johnson Consumer Inc. BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 10000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 69968-0094_3a697d0d-70fd-46e3-a67a-fdfd943f77c5 69968-0094 HUMAN OTC DRUG Neutrogena Healthy Skin Glow Sheers Illuminating Tinted Moisturizer - Ivory to Fair 10 Sunscreen Broad Spectrum SPF30 Homosalate, Octinoxate, Octisalate, Oxybenzone, and Titanium Dioxide LIQUID TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 50; 75; 50; 40; 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0096_e62a8b91-1e78-46e7-a62a-1a3a4caf6c79 69968-0096 HUMAN OTC DRUG Aveeno Baby Bathtime Solutions Baby and Mommy Gift Set Dimethicone KIT 20151118 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. N 20181231 69968-0097_123bc229-2871-478c-b9ff-0dc8cfce47ea 69968-0097 HUMAN OTC DRUG Listerine SmartRinse Anticavity Rinse Disney Princess Fab BubbleGum Sodium Fluoride MOUTHWASH ORAL 20151130 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 69968-0098_12225236-0ffa-4c01-b2a9-d75cffe1850b 69968-0098 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 50; 40; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0099_1b68cc0f-47e1-4ea1-b1eb-f6f75992e0e7 69968-0099 HUMAN OTC DRUG Neutrogena Oil-Free Acne Wash Pink Grapefruit Foaming Scrub Salicylic acid SUSPENSION TOPICAL 20151207 20180601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0101_bd85c4ef-eeaf-414b-834a-cd8e61ae017e 69968-0101 HUMAN OTC DRUG Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY TOPICAL 20161001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 30; 40; 20; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0103_bb08f41c-0cc3-4a07-b06c-63ba3ca0d47c 69968-0103 HUMAN OTC DRUG Neutrogena Healthy Skin Anti-Wrinkle System Avobenzone, Octisalate, Octocrylene, and Oxybenzone KIT 20150916 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. N 20181231 69968-0104_21411b4c-a64d-47e6-827f-da6cea8014b6 69968-0104 HUMAN OTC DRUG RoC Retinol Correxion Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20071101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 30; 50 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0105_834f523f-d62b-4df7-bce5-a51434c237a7 69968-0105 HUMAN OTC DRUG Neutrogena SkinClearing complexion perfector Fair 10 Salicylic acid LOTION TOPICAL 20151201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 69968-0106_834f523f-d62b-4df7-bce5-a51434c237a7 69968-0106 HUMAN OTC DRUG Neutrogena SkinClearing complexion perfector Light 20 Salicylic acid LOTION TOPICAL 20151201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 69968-0107_834f523f-d62b-4df7-bce5-a51434c237a7 69968-0107 HUMAN OTC DRUG Neutrogena SkinClearing complexion perfector Light to Medium 30 Salicylic acid LOTION TOPICAL 20151201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 69968-0108_834f523f-d62b-4df7-bce5-a51434c237a7 69968-0108 HUMAN OTC DRUG Neutrogena SkinClearing complexion perfector Medium 40 Salicylic acid LOTION TOPICAL 20151201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 69968-0110_e576e5a9-83a2-44db-923d-19918eb8a2c8 69968-0110 HUMAN OTC DRUG Neutrogena Acne Proofing cleanser Salicylic Acid GEL TOPICAL 20171001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/g N 20181231 69968-0112_693caf40-6bd6-4abc-85f0-a98fa3262569 69968-0112 HUMAN OTC DRUG Neutrogena Acne Proofing daily scrub Salicylic Acid GEL TOPICAL 20171001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/g N 20181231 69968-0113_7b1bf796-b9b1-48c9-973d-773e9a8f8137 69968-0113 HUMAN OTC DRUG Aveeno Baby continuous Protection sensitive skin Face Sunscreen Broad Spectrum SPF50 Titanium Dioxide and Zinc Oxide STICK TOPICAL 20130901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE; ZINC OXIDE 81; 68 mg/g; mg/g N 20181231 69968-0122_c0136555-9d55-48cc-845b-abb23e3d06b3 69968-0122 HUMAN OTC DRUG Neutrogena nourishing LONG WEAR makeup sunscreen broad spectrum SPF 20 honey 85 Titanium Dioxide LOTION TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 28 mg/mL N 20181231 69968-0123_c0136555-9d55-48cc-845b-abb23e3d06b3 69968-0123 HUMAN OTC DRUG Neutrogena nourishing LONG WEAR makeup sunscreen broad spectrum SPF 20 cocoa 115 Titanium Dioxide LOTION TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 28 mg/mL N 20181231 69968-0124_c0136555-9d55-48cc-845b-abb23e3d06b3 69968-0124 HUMAN OTC DRUG Neutrogena nourishing LONG WEAR makeup sunscreen broad spectrum SPF 20 chestnut 135 Titanium Dioxide LOTION TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 28 mg/mL N 20181231 69968-0125_cf287246-e2ed-46be-bfaa-6ee1b68fa5da 69968-0125 HUMAN OTC DRUG Aveeno Active Naturals Daily Moisturizing Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20071201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0127_5d89b403-ec40-47a5-872f-73c361324c93 69968-0127 HUMAN OTC DRUG Aveeno Active naturals Clear Complexion Cleanser Salicylic Acid CREAM TOPICAL 20161101 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/g N 20181231 69968-0128_a7fcc60e-3009-415e-9ba8-f8720cdc821d 69968-0128 HUMAN OTC DRUG Neutrogena Rapid Clear Foaming Scrub Salicylic Acid GEL TOPICAL 20161001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0131_a4721257-3afe-42f5-9b5a-7e37b38f0b56 69968-0131 HUMAN OTC DRUG Neutrogena Rapid Clear Acne Defense Face Salicylic Acid LOTION TOPICAL 20090101 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0132_a5765b73-4086-4738-97a9-cf8d0205e661 69968-0132 HUMAN OTC DRUG Neutrogena Healthy Skin Firming Sunscreen Broad Spectrum SPF15 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20101002 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0133_3fa33163-dba6-4595-8bef-4a31e987bb2b 69968-0133 HUMAN OTC DRUG Neutrogena Deep Moisture Day with Sunscreen Broad Spectrum SPF20 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/g; mg/g; mg/g; mg/g N 20181231 69968-0134_a0e24453-9b68-4c16-b9ba-378b3fbe7701 69968-0134 HUMAN OTC DRUG Neutrogena Men Age Fighter Face Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20140901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 15; 50; 30; 40 mg/g; mg/g; mg/g; mg/g N 20181231 69968-0135_e34b8aac-2f5c-4b78-bb3c-3a7cc5a8a6c2 69968-0135 HUMAN OTC DRUG Neutrogena Men Triple Protect Face Broad Spectrum SPF20 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0136_d2941d71-f715-41d6-8f73-38f816298e70 69968-0136 HUMAN OTC DRUG Neutrogena Ageless Intensives Anti Wrinkle Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF20 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20070201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 70; 40; 15; 20 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0137_c9e9a9b0-9515-4c8d-8963-8d0acaf3e3ab 69968-0137 HUMAN OTC DRUG Neutrogena Blackhead Eliminating Daily Scrub Salicylic Acid GEL TOPICAL 20160601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0139_e9471fdc-4fd1-4a4d-b4ef-68bec96c52bd 69968-0139 HUMAN OTC DRUG Aveeno Baby Calming comfort bath plus set Dimethicone KIT 20161101 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. N 20181231 69968-0140_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0140 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Classic Ivory 10 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0141_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0141 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Natural Ivory 20 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0142_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0142 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Buff 30 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0143_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0143 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Nude 40 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0144_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0144 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Soft Beige 50 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0145_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0145 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Natural Beige 60 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0146_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0146 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Fresh Beige 70 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0147_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0147 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Medium Beige 80 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0148_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0148 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Warm Beige 90 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0149_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0149 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Natural Tan 100 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0150_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0150 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Honey 85 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0151_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0151 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Caramel 105 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0152_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0152 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Cocoa 115 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0153_9b7b10db-461a-4b31-8f8c-4c7be502e537 69968-0153 HUMAN OTC DRUG Neutrogena Healthy Skin Makeup Sunscreen Broad Spectrum SPF20 - Chestnut 135 Titanium Dioxide LIQUID TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 24 mg/mL N 20181231 69968-0155_22c4fbe9-17e8-411b-b37d-f10af478bd31 69968-0155 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Cleanser Salicylic Acid CREAM TOPICAL 20110215 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0156_0ff522a0-4443-4b55-9bc7-309fc9d8ab6b 69968-0156 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Redness Soothing Cream Cleanser Salicylic Acid LOTION TOPICAL 20090501 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0157_b7f55873-5381-4ffe-997c-40bedf318193 69968-0157 HUMAN OTC DRUG Aveeno Soothing Bath Treatment Colloidal oatmeal POWDER TOPICAL 20000101 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 1000 mg/g N 20181231 69968-0158_05e0e853-4298-4f7f-93ba-80ea09ea4043 69968-0158 HUMAN OTC DRUG Neutrogena Rapid Clear 2 in 1 Fight and Fade Toner Salicylic Acid SOLUTION TOPICAL 20091001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0159_389516d4-81cb-4a79-8e40-b7a9a5344f48 69968-0159 HUMAN OTC DRUG Neutrogena Blackhead Eliminating Cleanser Mask Salicylic Acid LOTION TOPICAL 20111101 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0162_e3d9a45d-29c6-44af-b324-10d3d62d5ccf 69968-0162 HUMAN OTC DRUG Neutrogena Ultra Sheer SPF 55 and SPF 70 Suncare Kit Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone KIT 20160202 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. N 20181231 69968-0163_db5eba29-114a-4a67-91d7-e800a9151010 69968-0163 HUMAN OTC DRUG Aveeno favorites from clear complexion Salicylic acid KIT 20151202 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. N 20181231 69968-0164_edc4510a-67d1-44ae-b939-287fc1e1254b 69968-0164 HUMAN OTC DRUG Neutrogena On-the-Spot Acne Treatment Vanishing Formula Benzoyl Peroxide CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 25 mg/g N 20181231 69968-0165_8abcf217-e360-4550-934d-0050adee202b 69968-0165 HUMAN OTC DRUG Aveeno Baby Essential Daily Care Baby and Mommy Gift Set Dimethicone, Avobenzone, Octinoxate, and Octisalate KIT 20160201 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. N 20181231 69968-0166_196a91fc-35fe-432c-a2fa-eee20cee59de 69968-0166 HUMAN OTC DRUG Aveeno Baby Mommy and Me Gift Set Dimethicone KIT 20160210 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. N 20181231 69968-0167_1af0b568-18a3-46c8-9e52-b866eb10bee7 69968-0167 HUMAN OTC DRUG Neutrogena Oil Free Acne Wash Salicylic Acid GEL TOPICAL 20090201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0168_c7604f0e-4c29-4af3-9515-e72fa4f4616b 69968-0168 HUMAN OTC DRUG Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20070101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 28; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0169_6aa67e1a-58ea-468a-a5b4-0dbdd814c3d3 69968-0169 HUMAN OTC DRUG Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120605 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0170_7545c273-1db2-4ebc-8f2f-101d41b2f6a9 69968-0170 HUMAN OTC DRUG Neutrogena Healthy Skin Anti Wrinkle with sunscreen Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20140510 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 15; 50; 30; 40 mg/g; mg/g; mg/g; mg/g N 20181231 69968-0171_50b945ed-14b4-454d-b2e7-b8b6582bbbfb 69968-0171 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20071005 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0173_55015f74-f260-4c2c-93f6-22bcfbb15e3e 69968-0173 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20070211 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 23.5; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0174_ac26fc7b-2018-40a3-8e34-b5be863289ab 69968-0174 HUMAN OTC DRUG Aveeno Active Naturals Hydrosport Sunscreen Broad spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20120524 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 80; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0175_d53a7973-9bdf-4e30-824e-6930e3fb1301 69968-0175 HUMAN OTC DRUG Neutrogena Wet Skin Swim Humidity Sweat Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 80; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0176_7587c718-f56f-4087-9d25-2b5ff161ed91 69968-0176 HUMAN OTC DRUG Neutrogena Wet Skin Swim Humidity Sweat Sunscreen Broad Spectrum SPF85 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101016 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0177_cf8a870d-8019-4bb1-b06e-36c32c927bda 69968-0177 HUMAN OTC DRUG Neutrogena Wet Skin Swim Humidity Sweat Sunscreen Broad Spectrum SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20101001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 100; 50; 100; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0178_9bff54ee-4753-44cb-af2d-294269146951 69968-0178 HUMAN OTC DRUG Listerine Total Care Fresh Mint Anticavity Sodium Fluoride MOUTHWASH ORAL 20091101 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 69968-0179_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0179 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Buff 30 Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0180_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0180 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Natural Beige 60 Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0181_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0181 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Natural Tan 100 Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0182_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0182 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Warm Beige 90 Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0183_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0183 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Medium Beige 80 Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0184_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0184 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Fresh Beige 70 Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0185_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0185 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Soft Beige 50 Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0186_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0186 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Nude 40 Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0187_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0187 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Natural Ivory 20 Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0188_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0188 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - Classic Ivory 10 Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0189_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0189 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - 85 Honey Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0190_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0190 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - 105 Caramel Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0191_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0191 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - 115 Cocoa Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0192_dea2483e-6d4b-4a9a-a195-2b682cc8be83 69968-0192 HUMAN OTC DRUG Neutrogena SkinClearing Oil Free Makeup - 135 Chestnut Salicylic Acid LIQUID TOPICAL 20150901 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 50 mg/mL N 20181231 69968-0193_5adba953-2294-4875-8d7a-9543ce558a26 69968-0193 HUMAN OTC DRUG Neutrogena Oil Free Acne Moisturizer Pink Grapefruit Salicylic Acid LOTION TOPICAL 20150303 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 69968-0194_3a40e227-127a-4ad8-8628-92265a4c738f 69968-0194 HUMAN OTC DRUG Listerine Total Care Zero Alcohol Anticavity Fresh Mint Sodium Fluoride MOUTHWASH ORAL 20120725 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 69968-0195_1cd1a6ea-2e8d-41ba-a141-71d0b4a4583a 69968-0195 HUMAN OTC DRUG Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20141201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 40; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0196_c6e33d99-e9d3-449f-acd9-3c474bee8640 69968-0196 HUMAN OTC DRUG Neutrogena CoolDry Sport Sunscreen SPF 50 with Micromesh Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27; 90; 45; 60; 45 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0198_81705bc2-4120-443c-a77f-a053cd82170a 69968-0198 HUMAN OTC DRUG Aveeno Baby Soothing Relief Moisturizing Dimethicone CREAM TOPICAL 20151022 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 125 mg/g N 20181231 69968-0199_ae390f8a-fdf1-4711-9943-e1a46e2ef0e8 69968-0199 HUMAN OTC DRUG Aveeno Baby Eczema Therapy Soothing Bath Treatment Oatmeal POWDER TOPICAL 20120101 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 430 mg/g N 20181231 69968-0200_e7253993-aa06-4c7a-9f2e-d71bb7b02b41 69968-0200 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup with sunscreen broad spectrum SPF Nude 40 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0201_e7253993-aa06-4c7a-9f2e-d71bb7b02b41 69968-0201 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup with sunscreen broad spectrum SPF 55 Warm Beige 90 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0202_e7253993-aa06-4c7a-9f2e-d71bb7b02b41 69968-0202 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup with sunscreen broad spectrum SPF55 Fresh Beige 70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0203_e7253993-aa06-4c7a-9f2e-d71bb7b02b41 69968-0203 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup with sunscreen broad spectrum SPF 55 Natural Beige 60 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0204_e7253993-aa06-4c7a-9f2e-d71bb7b02b41 69968-0204 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup with sunscreen broad spectrum SPF55 Soft Beige 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0205_e7253993-aa06-4c7a-9f2e-d71bb7b02b41 69968-0205 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup with sunscreen broad spectrum SPF 55 Classic Ivory 10 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0206_e7253993-aa06-4c7a-9f2e-d71bb7b02b41 69968-0206 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup with sunscreen broad spectrum SPF55 Natural Ivory 20 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0207_e7253993-aa06-4c7a-9f2e-d71bb7b02b41 69968-0207 HUMAN OTC DRUG Neutrogena Healthy Skin Compact Makeup with sunscreen broad spectrum SPF 55 Buff 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 28; 80; 40; 90; 40 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0208_d62123cc-1e68-416b-a83f-483308522586 69968-0208 HUMAN OTC DRUG Neosporin Lip Health Overnight Renewal Therapy Petrolatum OINTMENT TOPICAL 20090603 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. PETROLATUM 774 mg/g N 20181231 69968-0209_73e91a76-a8f5-4f4f-8e9f-dc29249fb1bd 69968-0209 HUMAN OTC DRUG Clean and Clear Essentials Deep Cleaning Astringent Salicylic Acid LIQUID TOPICAL 20120430 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0210_84a13156-5eaa-432b-83c2-36b6f4af205f 69968-0210 HUMAN OTC DRUG Clean and Clear Essentials Deep Cleansing Toner Sensitive Skin Salicylic Acid LIQUID TOPICAL 20120427 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 69968-0211_f7d15eb7-92ca-4a8d-aad3-f03bd9acf89a 69968-0211 HUMAN OTC DRUG Clean and Clear Advantage 3 in 1 Exfoliating Benzoyl Peroxide CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 50 mg/g N 20181231 69968-0212_7408f3eb-6d1b-47ee-8d59-2569fd730dd7 69968-0212 HUMAN OTC DRUG Clean and Clear Persa-Gel 10 Benzoyl Peroxide GEL TOPICAL 20091101 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 100 mg/g N 20181231 69968-0213_054c351f-f66c-4c84-ae8b-4ffd46b6e174 69968-0213 HUMAN OTC DRUG Aveeno Active Naturals Clear Complexion Foaming Cleanser Salicylic Acid LIQUID TOPICAL 20080201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL N 20181231 69968-0214_af693cf6-56d1-4587-b683-8c9d2ca526e9 69968-0214 HUMAN OTC DRUG Aveeno Active Naturals Smart Essentials Daily Nourishing Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0215_ea35fa01-f76c-402b-9a16-88e44d4ba580 69968-0215 HUMAN OTC DRUG RoC Multi Correxion 5 in 1 Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0216_1f007a37-e11f-4401-8290-128655371c14 69968-0216 HUMAN OTC DRUG Aveeno Active naturals Clear Complexion Daily Cleansing pads Salicylic Acid CLOTH TOPICAL 20160301 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 6 mg/1 N 20181231 69968-0217_ac0095b4-024b-4cb4-84c7-f6ec6747cd02 69968-0217 HUMAN OTC DRUG Rembrandt Whitening Mint Intense Sodium Fluoride PASTE, DENTIFRICE ORAL 20151201 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE 1.5 mg/g N 20181231 69968-0218_7ace39bf-61eb-4bfe-b4fb-71dc65b6bb74 69968-0218 HUMAN OTC DRUG Neutrogena Oil Free Acne Stress Control Triple Action Toner Salicylic Acid LIQUID TOPICAL 20080501 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0219_9d02c8e7-50a6-469d-90b1-8e3cecbddad9 69968-0219 HUMAN OTC DRUG Desitin Rapid Relief Diaper Rash Zinc Oxide CREAM TOPICAL 20151020 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. ZINC OXIDE 130 mg/g N 20181231 69968-0220_de7639bb-ba44-4b56-b116-b7c28e232da8 69968-0220 HUMAN OTC DRUG Neosporin First AID Antiseptic Foaming for Kids Benzalkonium Chloride LIQUID TOPICAL 20090601 OTC MONOGRAPH NOT FINAL part333A Johnson & Johnson Consumer Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 69968-0221_65895fdd-5f45-4226-b2f6-6c229e3f8060 69968-0221 HUMAN OTC DRUG Band-Aid Brand Hurt-Free Antiseptic Pain Relieving Benzalkonium Chloride and Lidocaine Hydrochloride LIQUID TOPICAL 20111214 OTC MONOGRAPH NOT FINAL part333A Johnson & Johnson Consumer Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 20 mg/mL; mg/mL N 20181231 69968-0222_550e9d2f-9e67-4100-a0f1-456123ac26fc 69968-0222 HUMAN OTC DRUG Aveeno favorites from Positively radiant Avobenzone, Octinoxate, and Octisalate KIT 20160422 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. N 20181231 69968-0223_720ba0f3-3eb1-44d6-ad0d-2f574a895d75 69968-0223 HUMAN OTC DRUG Benadryl Extra Strength Itch Stopping Diphenhydramine Hydrochloride and Zinc Acetate CREAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 69968-0224_3192839c-9104-4c89-81fa-7e7803a2c22f 69968-0224 HUMAN OTC DRUG RoC Multi Correxion 5 in 1 Chest, Neck and Face Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene CREAM TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 20; 40; 40; 20 mg/g; mg/g; mg/g; mg/g N 20181231 69968-0232_ecd92253-337d-43b7-a864-3f996af3dde4 69968-0232 HUMAN OTC DRUG Neutrogena deep clean cooling scrub Salicylic Acid GEL TOPICAL 20171001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0233_a36a0d30-421c-469c-8348-ae73b32a2d5d 69968-0233 HUMAN OTC DRUG Neutrogena deep clean purifying clay cleanser/mask Salicylic Acid CREAM TOPICAL 20171001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0234_767b682c-1912-49df-94d7-a7f55093e100 69968-0234 HUMAN OTC DRUG Clean and Clear blackhead eraser scrub Salicylic Acid CREAM TOPICAL 20160601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/g N 20181231 69968-0240_cee66a65-333c-457a-8a54-8d02e77f6e99 69968-0240 HUMAN OTC DRUG Bengay Vanishing Scent Pain Relieving MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20091130 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. MENTHOL, UNSPECIFIED FORM 25 mg/g N 20181231 69968-0241_3d3e7272-9808-4355-a361-35104633f797 69968-0241 HUMAN OTC DRUG Childrens Benadryl Itch Cooling CAMPHOR (SYNTHETIC) GEL TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. CAMPHOR (SYNTHETIC) 4.5 mg/g N 20181231 69968-0242_e89718a7-039d-43de-803e-0ee6937e9866 69968-0242 HUMAN OTC DRUG Benadryl Extra Strength Itch Stopping Diphenhydramine Hydrochloride GEL TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part348 Johnson & Johnson Consumer Inc. DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/mL N 20181231 69968-0243_0e211f2d-00a8-4b84-9981-7c95354db5de 69968-0243 HUMAN OTC DRUG Neosporin Eczema Essentials Daily Moisturizing Oatmeal CREAM TOPICAL 20111015 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 10 mg/g N 20181231 69968-0246_90e85396-c346-4258-98d2-9a58047a259e 69968-0246 HUMAN OTC DRUG Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF70 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone STICK TOPICAL 20131005 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 30 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0247_f6550a89-d935-438e-9a0d-24f765937507 69968-0247 HUMAN OTC DRUG Neutrogena Oil-Free Acne Wash Pink Grapefruit Foaming Scrub Salicylic acid GEL TOPICAL 20160601 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0251_5c44180d-9553-459a-a631-38c2c8cc1bc1 69968-0251 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Sheeer Shimmer 10 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g N 20181231 69968-0252_5c44180d-9553-459a-a631-38c2c8cc1bc1 69968-0252 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Soft Caramel 50 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g N 20181231 69968-0253_5c44180d-9553-459a-a631-38c2c8cc1bc1 69968-0253 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Healthy Blush 20 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g N 20181231 69968-0254_5c44180d-9553-459a-a631-38c2c8cc1bc1 69968-0254 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Petal Glow 40 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g N 20181231 69968-0255_5c44180d-9553-459a-a631-38c2c8cc1bc1 69968-0255 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Sunny Berry 30 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g N 20181231 69968-0256_5c44180d-9553-459a-a631-38c2c8cc1bc1 69968-0256 HUMAN OTC DRUG Neutrogena Revitalizing Lip Balm SPF 20 - Fresh Plum 60 Octinoxate and Oxybenzone LIPSTICK TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. OCTINOXATE; OXYBENZONE 75; 50 mg/g; mg/g N 20181231 69968-0260_303f4179-fbe1-4bbb-b3c0-9376ff28de6c 69968-0260 HUMAN OTC DRUG Neutrogena Healthy Skin Brightening Eye Perfector Sunscreen Broad Spectrum SPF25 - Medium 15 Titanium Dioxide CREAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 18.8 mg/g N 20181231 69968-0261_303f4179-fbe1-4bbb-b3c0-9376ff28de6c 69968-0261 HUMAN OTC DRUG Neutrogena Healthy Skin Brightening Eye Perfector Sunscreen Broad Spectrum SPF25 - Light 10 Titanium Dioxide CREAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 18.8 mg/g N 20181231 69968-0262_303f4179-fbe1-4bbb-b3c0-9376ff28de6c 69968-0262 HUMAN OTC DRUG Neutrogena Healthy Skin Brightening Eye Perfector Sunscreen Broad Spectrum SPF25 - Buff 09 Titanium Dioxide CREAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 18.8 mg/g N 20181231 69968-0263_303f4179-fbe1-4bbb-b3c0-9376ff28de6c 69968-0263 HUMAN OTC DRUG Neutrogena Healthy Skin Brightening Eye Perfector Sunscreen Broad Spectrum SPF25 - Fair 05 Titanium Dioxide CREAM TOPICAL 20091101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE 18.8 mg/g N 20181231 69968-0264_155d34da-9422-4c97-b422-0c7f55e6afee 69968-0264 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Honey Beige Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0265_155d34da-9422-4c97-b422-0c7f55e6afee 69968-0265 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Soft Beige Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0266_155d34da-9422-4c97-b422-0c7f55e6afee 69968-0266 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Nude Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0267_155d34da-9422-4c97-b422-0c7f55e6afee 69968-0267 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Buff Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0268_155d34da-9422-4c97-b422-0c7f55e6afee 69968-0268 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Natural Ivory Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0272_69f2d6fd-b82c-4a28-b531-7ae889017fd5 69968-0272 HUMAN OTC DRUG Neutrogena Sheer Zinc DRY-TOUCH Sunscreen Broad Spectrum SPF30 Zinc Oxide LOTION TOPICAL 20161001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. ZINC OXIDE 182.4 mg/mL N 20181231 69968-0274_8859a0a2-f5ff-4d09-9a6d-a75b02b77c90 69968-0274 HUMAN OTC DRUG Neutrogena Sheer Zinc DRY-TOUCH Sunscreen Broad Spectrum SPF50 Zinc Oxide LOTION TOPICAL 20161001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. ZINC OXIDE 216 mg/mL N 20181231 69968-0275_fc6300ed-dfe7-4bde-89d0-d39836dcdd53 69968-0275 HUMAN OTC DRUG Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50 Zinc Oxide LOTION TOPICAL 20161001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. ZINC OXIDE 216 mg/mL N 20181231 69968-0276_ef9ef689-0eba-4f1b-8759-e0c7f3eb8191 69968-0276 HUMAN OTC DRUG Listerine Smart Rinse Anticavity Rinse - Frozen Bubble Blast sodium fluoride MOUTHWASH ORAL 20110101 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 69968-0291_60c28741-c326-4374-b44d-b61fba7c0695 69968-0291 HUMAN OTC DRUG Neutrogena Rapid Clear Stubborn Acne Cleanser Benzoyl Peroxide LOTION TOPICAL 20141201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. BENZOYL PEROXIDE 100 mg/mL N 20181231 69968-0299_aca31fd2-3c6d-4248-85f5-8982ddaa6cba 69968-0299 HUMAN OTC DRUG Neutrogena Healthy Skin Face Sunscreen Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 15; 50; 30; 40 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0300_53711eaf-3427-43f2-8c1f-81461325173b 69968-0300 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 100 Plus Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20091001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 100; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0301_b79acd72-63e5-4437-bbe8-598988c13ef1 69968-0301 HUMAN OTC DRUG Neutrogena Acne Proofing whipped foam cleanser Salicylic Acid AEROSOL, FOAM TOPICAL 20171001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/g N 20181231 69968-0303_adf957d9-69bb-4136-86ba-12db0d19d20b 69968-0303 HUMAN OTC DRUG Aveeno ultra-calming daily moisturizer Broad Spectrum SPF 30 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE; ZINC OXIDE 43; 3 mg/mL; mg/mL N 20181231 69968-0304_6aba385a-4582-4857-9843-b23ee471db04 69968-0304 HUMAN OTC DRUG Aveeno Baby continuous protection sensitive skin Sunscreen Broad Spectrum SPF50 Zinc Oxide LOTION TOPICAL 20161001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. ZINC OXIDE 216 mg/mL N 20181231 69968-0305_db68297a-6060-475f-a728-8252f9877711 69968-0305 HUMAN OTC DRUG Lubriderm Daily Moisture with Sunscreen Broad Spectrum SPF15 Avobenzone, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20100701 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 40; 30; 22 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0307_85f5784b-eba5-4594-93e5-b74f51f8fd80 69968-0307 HUMAN OTC DRUG Aveeno ACTIVE NATURALS positively radiant sheer daily moisturizer Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 15; 5; 4; 6 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0308_d38745b6-e6cf-4f86-9905-10ada01657b8 69968-0308 HUMAN OTC DRUG Aveeno ACTIVE NATURALS absolutely ageless leave-on day mask Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 15; 5; 4; 6 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0309_155d34da-9422-4c97-b422-0c7f55e6afee 69968-0309 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Classic Ivory Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0310_155d34da-9422-4c97-b422-0c7f55e6afee 69968-0310 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Natural Beige Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0311_155d34da-9422-4c97-b422-0c7f55e6afee 69968-0311 HUMAN OTC DRUG Neutrogena SkinClearing Mineral - Tan Salicylic Acid POWDER TOPICAL 20091130 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0315_4cca2198-5a6e-4b9a-a5d4-0aa25d5167c1 69968-0315 HUMAN OTC DRUG Neutrogena HydroBoost Water Gel Sunscreen Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 27; 90; 50; 90; 45 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0316_7ca4736c-9f7c-455c-b797-1e95899a6111 69968-0316 HUMAN OTC DRUG Neutrogena HydroBoost Water Gel Sunscreen Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 15; 50; 40; 60 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0320_5a6ef8f5-725c-4550-bba5-ac3ec66d2591 69968-0320 HUMAN OTC DRUG Neutrogena Skin Polishing Acne Cleanser Salicylic Acid CREAM TOPICAL 20161201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 20 mg/mL N 20181231 69968-0322_efa8fff3-d571-498f-8107-560e21965118 69968-0322 HUMAN OTC DRUG Listerine Naturals Anticavity - Herbal Mint Sodium Fluoride MOUTHWASH ORAL 20131220 OTC MONOGRAPH FINAL part355 Johnson & Johnson Consumer Inc. SODIUM FLUORIDE .1 mg/mL N 20181231 69968-0323_32271d0f-cd95-4cde-9020-fcb8d13847c4 69968-0323 HUMAN OTC DRUG Aveeno ACTIVE NATURALS skin relief diabetics dry skin moisturizing Dimethicone LOTION TOPICAL 20171001 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. DIMETHICONE 12 mg/mL N 20181231 69968-0327_9056489e-880a-4b60-bbfd-5613bce72caf 69968-0327 HUMAN OTC DRUG Petite Planet Multi purpose Healing balm Petrolatum CREAM TOPICAL 20171201 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. PETROLATUM 69 mg/g N 20181231 69968-0334_33482933-71c1-48e7-9809-07ae7e783e63 69968-0334 HUMAN OTC DRUG Neutrogena sensitive skin face Liquid Sunscreen Broad Spectrum SPF50 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20101101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. TITANIUM DIOXIDE; ZINC OXIDE 49; 29 mg/mL; mg/mL N 20181231 69968-0336_b1a68258-5512-4e29-bd6f-93ebe7dac46a 69968-0336 HUMAN OTC DRUG Neutrogena deep clean purifying whipped foam cleanser Salicylic Acid AEROSOL, FOAM TOPICAL 20171001 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0338_085a14b0-2745-4cdc-b0d9-20cd4525eea0 69968-0338 HUMAN OTC DRUG Neutrogena Skin Clearing Blemish Concealer - Deep 20 Salicylic Acid LIQUID TOPICAL 20171002 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0339_b7673291-9bac-4e7d-87a1-ee5bbce9c121 69968-0339 HUMAN OTC DRUG Neutrogena SkinClearing Mineral Powder - honey 85 Salicylic Acid CREAM TOPICAL 20171002 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0340_b7673291-9bac-4e7d-87a1-ee5bbce9c121 69968-0340 HUMAN OTC DRUG Neutrogena SkinClearing Mineral Powder - Chestnut 135 Salicylic Acid CREAM TOPICAL 20171002 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/g N 20181231 69968-0341_2d6e1d44-2381-4c5f-9ca3-cd338e262079 69968-0341 HUMAN OTC DRUG Aveeno positively radiant targeted dark spot corrector Broad Spectrum SPF 15 Avobenzone, Octinoxate, and Octisalate CREAM TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; OCTINOXATE; OCTISALATE 3; 75; 2 mg/mL; mg/mL; mg/mL N 20181231 69968-0342_bc7a2a64-4a2a-42c8-beda-40290b47d483 69968-0342 HUMAN OTC DRUG Neutrogena Oil-Free Moisture Sunscreen Broad Spectrum SPF 35 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION TOPICAL 20100601 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 120; 50; 23.5; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 69968-0344_b37a72c3-d8ce-4f96-a1f3-c59307a863d9 69968-0344 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 150; 50; 23.5; 60 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0345_668e2aea-a265-4eda-9c4b-ef36d6e51a65 69968-0345 HUMAN OTC DRUG Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Johnson & Johnson Consumer Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 80; 40; 23.5; 50 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 69968-0354_58bf0c66-ce8b-4281-a556-e777fdaa72bd 69968-0354 HUMAN OTC DRUG Johnsons Bath Discovery baby Gift Set Zinc Oxide KIT 20160707 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. N 20181231 69968-0369_a168a457-0e2c-42de-b382-f5399436c506 69968-0369 HUMAN OTC DRUG Aveeno Baby Eczema Therapy Nighttime Balm Oatmeal CREAM TOPICAL 20171201 OTC MONOGRAPH FINAL part347 Johnson & Johnson Consumer Inc. OATMEAL 10 mg/g N 20181231 69968-1019_834f523f-d62b-4df7-bce5-a51434c237a7 69968-1019 HUMAN OTC DRUG Neutrogena SkinClearing complexion perfector Deep 50 Salicylic acid LOTION TOPICAL 20151201 OTC MONOGRAPH FINAL part333D Johnson & Johnson Consumer Inc. SALICYLIC ACID 5 mg/mL E 20171231 69969-001_dcf99d70-bfaa-43b5-8699-36bd8192f2ee 69969-001 HUMAN OTC DRUG Natural Ginseng Toner ALLANTOIN LIQUID TOPICAL 20150705 OTC MONOGRAPH FINAL part347 CORPORATION SORISO ALLANTOIN .1 g/100mL E 20171231 69969-002_43ca55b4-5697-4de9-859c-db57b58f6ba7 69969-002 HUMAN OTC DRUG Natural Ginseng Emulsion ALLANTOIN LIQUID TOPICAL 20150705 OTC MONOGRAPH FINAL part347 CORPORATION SORISO ALLANTOIN .01 g/100mL E 20171231 69969-003_76d68529-ed72-4b7b-9f39-504bc11ba227 69969-003 HUMAN OTC DRUG Natural Ginseng Serum ALLANTOIN LIQUID TOPICAL 20150705 OTC MONOGRAPH FINAL part347 CORPORATION SORISO ALLANTOIN .1 g/100mL E 20171231 69969-004_8779dbc1-213b-43f7-a0a3-d7e3b49839e5 69969-004 HUMAN OTC DRUG Mulberry Toner ALLANTOIN LIQUID TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO ALLANTOIN .1 g/100mL E 20171231 69969-005_7375e21c-85cf-4466-a6ad-20468306d403 69969-005 HUMAN OTC DRUG Mulberry Emulsion ALLANTOIN LIQUID TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO ALLANTOIN .1 g/100mL E 20171231 69969-006_10ae37f7-7019-4382-b081-75cc664b9011 69969-006 HUMAN OTC DRUG Mulberry Serum ALLANTOIN LIQUID TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO ALLANTOIN .1 g/100mL E 20171231 69969-007_edce2a9a-4abd-46ea-8db6-03f7ebce05cf 69969-007 HUMAN OTC DRUG Soriso bright aqua Moisture GLYCERIN CREAM TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO GLYCERIN 2 g/100mL E 20171231 69969-008_f89414c9-caf5-47d5-8f1d-8f24f8c80ffb 69969-008 HUMAN OTC DRUG Soriso Bright Aqua Pack GLYCERIN CREAM TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO GLYCERIN 6 g/100mL E 20171231 69969-009_89d255a4-0af2-4f83-acd9-84882692dbbb 69969-009 HUMAN OTC DRUG Rg1 ALLANTOIN LOTION TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO ALLANTOIN .1 g/100mL E 20171231 69969-010_abc09c53-f844-4230-ba9c-83f968207ca1 69969-010 HUMAN OTC DRUG Ginsenoside Rg1 Rejuvenating Moisturizing GLYCERIN CREAM TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO GLYCERIN .1 g/100mL E 20171231 69969-011_da783c28-4c41-4178-a117-56f1e648636a 69969-011 HUMAN OTC DRUG Deer Velvet Ampoule GLYCERIN LIQUID TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO GLYCERIN 6 g/100mL E 20171231 69969-012_179bc67a-67c2-44c7-b282-9d3e2206b113 69969-012 HUMAN OTC DRUG GMDANSU Ampoule GLYCERIN LIQUID TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO GLYCERIN 6 g/100mL E 20171231 69969-013_689d4219-0be5-40dc-84de-5b59e5887e42 69969-013 HUMAN OTC DRUG GMDANSU Snail Blemish Balm ALLANTOIN CREAM TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO ALLANTOIN .1 g/100mL E 20171231 69969-014_63ec4213-5656-40b1-8b75-056b19d59316 69969-014 HUMAN OTC DRUG GMDANSU Herbal Mask Sheet ALLANTOIN LIQUID TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO ALLANTOIN .19 g/100g E 20171231 69969-015_b7e3225a-4466-4155-90bf-d7f76616af68 69969-015 HUMAN OTC DRUG GMDANSU Skin ALLANTOIN LOTION TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO ALLANTOIN .5 g/100mL E 20171231 69969-016_b670b5fc-8397-4290-abe0-7e607f29bb90 69969-016 HUMAN OTC DRUG GMDANSU Eye Serum ALLANTOIN LIQUID TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO ALLANTOIN .1 g/100mL E 20171231 69969-017_989eb10c-eccf-466c-98a9-6a2b9d6abea0 69969-017 HUMAN OTC DRUG GMDANSU Eye Serum ALLANTOIN LIQUID TOPICAL 20150710 OTC MONOGRAPH FINAL part347 CORPORATION SORISO ALLANTOIN .19 g/100g E 20171231 69969-018_d43aebfb-ea28-412d-9fc1-1454668927c5 69969-018 HUMAN OTC DRUG Green Wheatgrass Facial Cleansing GLYCERIN CREAM TOPICAL 20151223 OTC MONOGRAPH FINAL part347 CORPORATION SORISO GLYCERIN 10 g/100g E 20171231 69969-019_ecd5e1ba-613c-479c-a575-17f6d11c6b5b 69969-019 HUMAN OTC DRUG Pink Sweet Potato Facial Cleansing GLYCERIN CREAM TOPICAL 20151223 OTC MONOGRAPH FINAL part347 CORPORATION SORISO GLYCERIN 10 g/100g E 20171231 69969-020_5505d010-5ed2-4e8b-ba26-497408f312c0 69969-020 HUMAN OTC DRUG Mint Blue Facial Mask GLYCERIN LIQUID TOPICAL 20151223 OTC MONOGRAPH FINAL part347 CORPORATION SORISO GLYCERIN 10 g/100g E 20171231 69969-021_6148772c-e7ab-4cef-8015-4b6f96e93d2c 69969-021 HUMAN OTC DRUG Natural Cocktail Pack GLYCERIN SOLUTION TOPICAL 20151223 OTC MONOGRAPH FINAL part347 CORPORATION SORISO GLYCERIN 6 g/100mL E 20171231 69973-035_f38c3067-3e3f-45fe-9dd2-814bc7bd3210 69973-035 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid TABLET ORAL 20150730 NDA NDA022418 Halton Laboratories FENOFIBRIC ACID 35 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 69973-105_f38c3067-3e3f-45fe-9dd2-814bc7bd3210 69973-105 HUMAN PRESCRIPTION DRUG Fenofibric Acid Fenofibric Acid TABLET ORAL 20150730 NDA NDA022418 Halton Laboratories FENOFIBRIC ACID 105 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 69975-750_024105d7-d4a4-4370-acfe-854032e043f5 69975-750 HUMAN OTC DRUG Colistat DOCUSATE SODIUM TABLET, FILM COATED ORAL 20150716 OTC MONOGRAPH NOT FINAL part334 Amvilab LLC DOCUSATE SODIUM 100 mg/1 E 20171231 69975-850_660a615d-acb0-4763-ab9b-cd0b6300d24e 69975-850 HUMAN OTC DRUG Colistat Plus DOCUSATE SODIUM,SENNOSIDES TABLET, FILM COATED ORAL 20150716 OTC MONOGRAPH NOT FINAL part334 Amvilab LLC DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 E 20171231 69975-870_998ce6dd-0c91-407a-8d3d-992f3f688165 69975-870 HUMAN OTC DRUG Blonil Simethicone TABLET, CHEWABLE ORAL 20150716 OTC MONOGRAPH FINAL part347 Amvilab LLC DIMETHICONE 80 mg/1 E 20171231 69976-001_2f43b62b-1b39-4068-807a-28e70b5c309a 69976-001 HUMAN OTC DRUG Infant Diaper Cream Anne Geddes Zinc Oxide CREAM TOPICAL 20150710 OTC MONOGRAPH FINAL part346 HR Pharma LLC ZINC OXIDE 10 g/100g E 20171231 69976-002_7732c705-dc57-4a05-aff5-54a9d46b4581 69976-002 HUMAN OTC DRUG Infant Nasal Anne Geddes Sodium Chloride LIQUID NASAL 20150713 OTC MONOGRAPH FINAL part349 HR Pharma LLC SODIUM CHLORIDE .65 g/100mL E 20171231 69976-003_6d549392-373e-42e4-8154-66724fe19f6a 69976-003 HUMAN OTC DRUG Anne Geddes Infant Anti-Gas Drops Simethicone LIQUID ORAL 20150922 OTC MONOGRAPH FINAL part332 HR Pharma LLC DIMETHICONE 21 mg/100mL E 20171231 69977-010_0ee3b24e-7e20-4268-ab9b-159732c8ae7b 69977-010 HUMAN OTC DRUG CLAPIEL DETOC PACK SUPER LIFTING PACK THIOREDOXIN SOLUTION TOPICAL 20150501 UNAPPROVED DRUG OTHER AUS KOREA CO., LTD. THIOREDOXIN .48 mg/101 E 20171231 69977-020_989c9f37-8168-4bf5-b0a1-e8065fdb41d2 69977-020 HUMAN OTC DRUG Clapiel Hyalon Serum HYALURONATE SODIUM, NIACINAMIDE CREAM TOPICAL 20150501 UNAPPROVED DRUG OTHER AUS KOREA CO., LTD. NIACINAMIDE; HYALURONATE SODIUM .6; 10.5 mg/30mL; mg/30mL E 20171231 69977-030_a8c9dd1d-7307-414e-87c8-cad3cde0ee4f 69977-030 HUMAN OTC DRUG Clapiel Mineral CC Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 AUS KOREA CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.5; .1 mg/50mL; mg/50mL E 20171231 69977-040_adfd7f1c-08da-4038-a450-6639ff56a5bc 69977-040 HUMAN OTC DRUG Clapiel Revital Serum Dimethicone CREAM TOPICAL 20150501 OTC MONOGRAPH FINAL part347 AUS KOREA CO., LTD. DIMETHICONE 6 mg/30mL E 20171231 69977-050_3173e183-37cc-49ae-a61b-09165c24d6b0 69977-050 HUMAN OTC DRUG Clapiel Defense Sunblock OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 AUS KOREA CO., LTD. OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE 3.4; 2.5; 2.25; 2 mg/50mL; mg/50mL; mg/50mL; mg/50mL E 20171231 69977-060_d46bc82d-ef2b-45f8-8b7c-2f704d679af2 69977-060 HUMAN OTC DRUG Clapiel Vita C Serum Glycerin CREAM TOPICAL 20150501 UNAPPROVED DRUG OTHER AUS KOREA CO., LTD. GLYCERIN 1.5 mg/30mL E 20171231 69978-001_f6ad262d-69fb-47ff-9371-382e5fd810cb 69978-001 HUMAN OTC DRUG SHINMO SAENGBALEUM HAIR PANTHENOL SHAMPOO TOPICAL 20150716 UNAPPROVED DRUG OTHER ATEC&CO INC. PANTHENOL .95 g/958.5g E 20171231 69978-002_a3d9b832-0e66-417c-80e2-c14dae83123c 69978-002 HUMAN OTC DRUG SHINMO SAENGBALEUM TREATMENT PANTHENOL GEL TOPICAL 20150720 UNAPPROVED DRUG OTHER ATEC&CO INC. PANTHENOL .95 g/958.5g E 20171231 69981-712_618470c1-de3f-9868-e053-2a91aa0a6a8d 69981-712 HUMAN OTC DRUG CUREFINI PETROLATUM, COD LIVER OINTMENT TOPICAL 20130117 OTC MONOGRAPH FINAL part347 Rev Pharma Corp. PETROLATUM; COD LIVER OIL 300; 100 mg/mL; mg/mL N 20181231 69981-729_48063228-ea36-498c-e054-00144ff88e88 69981-729 HUMAN OTC DRUG Curefini Dermal PETROLATUM CREAM TOPICAL 20160311 OTC MONOGRAPH FINAL part347 Rev Pharma Corp. PETROLATUM 300 mg/mL N 20181231 69981-754_482e2384-efb7-01c7-e054-00144ff88e88 69981-754 HUMAN OTC DRUG Curefini Dermal PETROLATUM, COD LIVER OINTMENT TOPICAL 20160802 OTC MONOGRAPH FINAL part347 Rev Pharma Corp PETROLATUM; COD LIVER OIL 300; 100 mg/mL; mg/mL N 20181231 69983-026_4934a7a8-43a3-727a-e054-00144ff88e88 69983-026 HUMAN OTC DRUG FungaBlend 10 TOLNAFTATE LIQUID TOPICAL 20150709 OTC MONOGRAPH FINAL part333C Happy Foot Shop, LLC TOLNAFTATE 10 mg/mL N 20181231 69990-100_5bac6947-e1f9-33ab-e053-2a91aa0a1930 69990-100 HUMAN OTC DRUG DURADRY PM Aluminum Chloride Hexahydrate GEL TOPICAL 20150101 OTC MONOGRAPH FINAL part350 Novadore USA, Inc. ALUMINUM CHLORIDE 150 mg/mL N 20181231 69990-200_5bac7bdc-a0a9-241a-e053-2991aa0a0bc0 69990-200 HUMAN OTC DRUG DURADRY AM Aluminum Zirconium Trichlorohydrex Glycine STICK TOPICAL 20150101 OTC MONOGRAPH FINAL part350 Novadore USA, Inc. ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY 20 g/100g N 20181231 69993-100_44db02db-4f46-4bc9-9f20-faac39fc89b4 69993-100 HUMAN OTC DRUG Maximum Strength Blue Emu Pain Relief Blu Emu Trolamine Salicylate SPRAY TOPICAL 20120604 OTC MONOGRAPH NOT FINAL part348 NFI Consumer Products TROLAMINE SALICYLATE 10 g/100mL N 20181231 69993-150_5baf85c0-6dc9-c37d-e053-2991aa0acae6 69993-150 HUMAN OTC DRUG Blue-Emu Anti-Itch Cream Hydrocortisone 1% CREAM TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part348 NFI Consumer Products HYDROCORTISONE 1 g/100g N 20181231 69993-250_5baf71e1-246d-293d-e053-2a91aa0ab65a 69993-250 HUMAN OTC DRUG Blue-Emu Maximum Arthritis Pain Relief Cream Trolamine Salicylate 10% CREAM TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part348 NFI Consumer Products TROLAMINE SALICYLATE 100 mg/g N 20181231 69993-350_592811f2-e21d-6a58-e053-2991aa0a69a9 69993-350 HUMAN OTC DRUG Blue-Emu Lidocaine Pain Relief Cream lidocaine cream 4% CREAM TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part348 NFI Consumer Products LIDOCAINE HYDROCHLORIDE 40 mg/1 N 20181231 69993-400_416ebf5a-2efc-6d0b-e054-00144ff88e88 69993-400 HUMAN OTC DRUG Lidocare 03 4% Lidocaine Patch PATCH TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part348 NFI Consumer Products LIDOCAINE 4 g/1 N 20181231 69993-450_5baf303b-de83-d39c-e053-2a91aa0aaef5 69993-450 HUMAN OTC DRUG Lidocare Arm, Neck, Leg 4% Lidocaine Patch PATCH TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part348 NFI Consumer Products LIDOCAINE 11 mg/1 N 20181231 69994-001_96c60497-1326-4cf4-a63f-60b28164948d 69994-001 HUMAN OTC DRUG Biolle Tears Carboxymethylcellulose Sodium, Unspecified Form SOLUTION/ DROPS OPHTHALMIC 20150601 OTC MONOGRAPH FINAL part349 SAGE Ethnographic Research, dba Biollé CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 5 mg/mL E 20171231 69994-002_14537a40-713b-4076-a858-1c5039e720ed 69994-002 HUMAN OTC DRUG Biolle Gel Tears Carboxymethylcellulose Sodium, Unspecified Form SOLUTION/ DROPS OPHTHALMIC 20150601 OTC MONOGRAPH FINAL part349 SAGE Ethnographic Research, dba Biollé CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 10 mg/mL E 20171231 69995-8915_c04e00c6-fac3-4127-94bb-af1510e46365 69995-8915 HUMAN PRESCRIPTION DRUG Oxygen Compressed Oxygen Gas GAS RESPIRATORY (INHALATION) 20150716 NDA NDA205840 A + OXYGEN & D.M.E. OXYGEN 992 mL/100mL N 20191231 69996-010_bde4f321-5dbb-4b05-828d-748a27b43ec5 69996-010 HUMAN OTC DRUG EASTER SCALP Pyrithione Zinc SOLUTION TOPICAL 20150601 OTC MONOGRAPH FINAL part358H WECOSMETICS Co. PYRITHIONE ZINC 2.4 mg/500mL N 20181231 69996-020_89fb44cc-95d0-4189-b401-f4bcdd68a73e 69996-020 HUMAN OTC DRUG EASTER SCALP TONIC Menthol, Salicylic Acid, Panthenol SPRAY TOPICAL 20150601 UNAPPROVED DRUG OTHER WECOSMETICS Co. MENTHOL; SALICYLIC ACID; PANTHENOL .3; .25; .2 mg/100mL; mg/100mL; mg/100mL N 20181231 69996-030_61fd41ed-4214-42f4-bfe4-10950019cf1e 69996-030 HUMAN OTC DRUG EASTER STEM CELL HAIR PERFECTION 22 Dimethicone SOLUTION TOPICAL 20150601 OTC MONOGRAPH FINAL part347 WECOSMETICS Co. DIMETHICONE 12 mg/200mL N 20181231 69997-010_29ad0de3-98e2-4676-b00b-79b4be2b6511 69997-010 HUMAN OTC DRUG Purlisse BB Tinted Moist Octinoxate, Titanium Dioxide, Zinc oxide CREAM TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.6; 1.69; 1.4 mg/40mL; mg/40mL; mg/40mL N 20181231 69997-020_8b3c70f3-a87d-42dc-8382-b8988953aa8a 69997-020 HUMAN OTC DRUG Purlisse BB Tinted Moist Light OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.6; 1.69; 1.4 g/40mL; g/40mL; g/40mL N 20181231 69997-030_fb41df9e-599c-4d16-a003-f908e427d6ca 69997-030 HUMAN OTC DRUG Purlisse BB Tinted Moist SPF30 Deep Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.6; 1.69; 1.4 g/40mL; g/40mL; g/40mL N 20181231 69997-040_81d203e4-b54b-465b-bf4a-a563aa27ae9f 69997-040 HUMAN OTC DRUG Purlisse BB Tinted Moist SPF30 Light Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.6; 1.69; 1.4 g/40mL; g/40mL; g/40mL N 20181231 69997-050_c36e41d9-aba9-4f3f-8d12-80bb8f09465a 69997-050 HUMAN OTC DRUG Purlisse BB Tinted Moist SPF30 Medium Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.6; 1.69; 1.4 g/40mL; g/40mL; g/40mL N 20181231 69997-060_e9fd090d-fc6e-43dc-a37c-422a124192e8 69997-060 HUMAN OTC DRUG touch in SOL Dark Out Long Lasting Primer Base FRESH GREEN Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 1.25; 1.22; .52 g/25mL; g/25mL; g/25mL N 20181231 69997-070_47ab72ee-0c22-4f4f-8ade-af3cb00e3b03 69997-070 HUMAN OTC DRUG touch in SOL Dark Long Lasting Primer Base BRIGHT PURPLE Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 1.25; 1.22; .52 g/25mL; g/25mL; g/25mL N 20181231 69997-080_15ff86d6-4e25-405d-a32f-4ebf1a7613b1 69997-080 HUMAN OTC DRUG touch in SOL Dark Long Lasting Primer Base PURE PEACH Octinoxate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 1.25; 1.22; .52 g/25mL; g/25mL; g/25mL N 20181231 69997-090_4f64d02b-8681-452c-97e9-d5e8ef6d7eb8 69997-090 HUMAN OTC DRUG touch in SOL Pang Pang Sun Cutting Titanium Dioxide, Zinc Oxide, Octinoxate POWDER TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 1.39; .29; .2 g/10g; g/10g; g/10g N 20181231 69997-100_af738854-928c-42a5-9ea0-ffe362b281d4 69997-100 HUMAN OTC DRUG touch in SOL Advanced Real Moisture Li quid Foundation 21 Nude Beige Titanium Dioxide, Octinoxate, Zinc Oxide LIQUID TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.83; 1.2; .29 g/30mL; g/30mL; g/30mL N 20181231 69997-110_bc8c356a-dd65-4a05-9106-26a5a0850c44 69997-110 HUMAN OTC DRUG touch in SOL Advanced Real Moisture Li quid Foundation 23 Natural Beige Titanium Dioxide, Octinoxate, Zinc Oxide LIQUID TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.83; 1.2; .29 g/30mL; g/30mL; g/30mL N 20181231 69997-120_15a3b744-0adf-4a0f-9016-31c49499e06e 69997-120 HUMAN OTC DRUG Purlisse BB Tinted Moist SPF30 Fair Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.6; 1.69; 1.4 g/40mL; g/40mL; g/40mL N 20181231 69997-130_a6e1163c-f70b-47b2-a585-7d0485af4f49 69997-130 HUMAN OTC DRUG Purlisse BB Tinted Moist SPF30 Medium Deep Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 BONNE CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 2.6; 1.69; 1.4 g/40mL; g/40mL; g/40mL N 20181231 69997-140_f60a26d4-bc60-473d-a233-5fb4db315213 69997-140 HUMAN OTC DRUG Forestheal Vitamin C Serum NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170801 UNAPPROVED DRUG OTHER BONNE CO., LTD. NIACINAMIDE; ADENOSINE 1.2; .02 g/60mL; g/60mL N 20181231 69997-150_96904d68-c8b2-4a8c-90ff-34fa823d7ca4 69997-150 HUMAN OTC DRUG Forestheal Vitamin C Moisturizer NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170801 UNAPPROVED DRUG OTHER BONNE CO., LTD. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 69997-160_4a16493e-fce5-4963-84fa-ea6add8e8d04 69997-160 HUMAN OTC DRUG Forestheal Eye NIACINAMIDE, ADENOSINE GEL TOPICAL 20170801 UNAPPROVED DRUG OTHER BONNE CO., LTD. NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 69998-010_9172a7e5-201e-4536-8b69-5d9653073b75 69998-010 HUMAN OTC DRUG SNAIL BEE HIGH CONTENT ESSENCE Glycerin CREAM TOPICAL 20150701 UNAPPROVED DRUG OTHER BENTON KOREA GLYCERIN 1.69 mg/60mL E 20171231 69998-020_213eafc5-2cb2-4fc5-a560-32afe999bf21 69998-020 HUMAN OTC DRUG SNAIL BEE HIGH CONTENT Glycerin LOTION TOPICAL 20150701 UNAPPROVED DRUG OTHER BENTON KOREA GLYCERIN 7.5 g/150mL E 20171231 69998-030_94168b70-2ab7-4b70-8fbd-7f21500b2bf1 69998-030 HUMAN OTC DRUG SNAIL BEE HIGH CONTENT MASK PACK Glycerin PATCH TOPICAL 20150701 UNAPPROVED DRUG OTHER BENTON KOREA GLYCERIN .8 g/101 E 20171231 69998-040_56ae3035-fd04-4cd3-af59-12d875401d2f 69998-040 HUMAN OTC DRUG SNAIL BEE HIGH CONTENT SKIN Glycerin LIQUID TOPICAL 20150701 UNAPPROVED DRUG OTHER BENTON KOREA GLYCERIN 5.92 g/150mL E 20171231 69998-050_92dda944-50d5-4bf2-a4e1-214369d139b2 69998-050 HUMAN OTC DRUG SNAIL BEE HIGH CONTENT STEAM Glycerin CREAM TOPICAL 20150701 UNAPPROVED DRUG OTHER BENTON KOREA GLYCERIN 3.3 g/50g E 20171231 69998-060_c54cbc5a-970f-4e77-8caf-8ba1adb4c465 69998-060 HUMAN OTC DRUG BENTON FERMENTATION EYE Glycerin CREAM TOPICAL 20160302 UNAPPROVED DRUG OTHER BENTON KOREA GLYCERIN .9 g/30g E 20171231 69998-070_f9124304-72f6-47c1-a854-ea5b6b9d0cfa 69998-070 HUMAN OTC DRUG BENTON FERMENTATION ESSENCE Glycerin CREAM TOPICAL 20160302 UNAPPROVED DRUG OTHER BENTON KOREA GLYCERIN 1 g/100mL E 20171231 69998-080_595ab192-faef-4891-8727-a7cdb333f858 69998-080 HUMAN OTC DRUG SNAIL BEE HIGH CONTENT 120mL Glycerin LOTION TOPICAL 20160501 UNAPPROVED DRUG OTHER BENTON KOREA GLYCERIN 6 g/120mL E 20171231 69998-090_13f6887b-84b7-4b20-ac39-2e9b7f1afba4 69998-090 HUMAN OTC DRUG ALOE BHA SKIN TONER Glycerin LIQUID TOPICAL 20160701 UNAPPROVED DRUG OTHER BENTON KOREA GLYCERIN 5.2 g/200mL E 20171231 69998-100_ae37e123-4ca3-4cc2-9ec9-c1d37950cd92 69998-100 HUMAN OTC DRUG ALOE PROPOLIS SOOTHING Allantoin GEL TOPICAL 20160701 OTC MONOGRAPH FINAL part347 BENTON KOREA ALLANTOIN .5 g/100mL E 20171231 69998-110_88470ddc-a3ea-40bd-b472-2c20a49b35c0 69998-110 HUMAN OTC DRUG HONEST CLEANSING FOA M Glycerin GEL TOPICAL 20160701 UNAPPROVED DRUG OTHER BENTON KOREA GLYCERIN 15 g/150g E 20171231 69998-120_1f29a709-6454-4040-aaa8-c40c9f3f4b28 69998-120 HUMAN OTC DRUG HONEST TT MIST Glycerin SPRAY TOPICAL 20160701 UNAPPROVED DRUG OTHER BENTON KOREA GLYCERIN .4 g/40mL E 20171231 69998-130_858f8c3a-be1c-48ac-aad0-bf47726d2210 69998-130 HUMAN OTC DRUG BENTON FERMENTATION EYE 10g Adenosine CREAM TOPICAL 20160801 UNAPPROVED DRUG OTHER BENTON KOREA ADENOSINE .004 g/10g E 20171231 69998-140_d47322c8-fe18-4b96-bdc9-1f9a825e85c2 69998-140 HUMAN OTC DRUG ALOE PROPOLIS SOOTHING 30mL Allantoin GEL TOPICAL 20160901 OTC MONOGRAPH FINAL part347 BENTON KOREA ALLANTOIN .15 g/30mL E 20171231 69998-150_8e184bfc-09d6-4ca7-abf6-3483a71a0ee1 69998-150 HUMAN OTC DRUG ALOE BHA SKIN TONER Salicylic Acid LIQUID TOPICAL 20161201 OTC MONOGRAPH FINAL part333D Benton Inc. SALICYLIC ACID 1 g/200mL N 20181231 69998-160_8092a66e-6449-4ae8-a4fe-dc41ab693821 69998-160 HUMAN OTC DRUG ALOE PROPOLIS SOOTHING GE L Allantoin GEL TOPICAL 20161201 OTC MONOGRAPH FINAL part347 Benton Inc. ALLANTOIN .5 g/100mL N 20181231 69998-170_b707c1bd-c285-411f-935d-5f5b90dfd5a0 69998-170 HUMAN OTC DRUG ALOE PROPOLIS SOOTHING Allantoin GEL TOPICAL 20160901 OTC MONOGRAPH FINAL part347 Benton Inc. ALLANTOIN .15 g/30mL N 20181231 70000-0100_7a6f992a-895f-4d02-a4a6-1e013c0ab047 70000-0100 HUMAN OTC DRUG Childrens Aller-Ease Fexofenadine Hydrochloride Fexofenadine Hydrochloride SUSPENSION ORAL 20160624 ANDA ANDA203330 Cardinal Health, Inc. FEXOFENADINE HYDROCHLORIDE 30 mg/5mL N 20181231 70000-0101_8019d1db-69e1-4938-8c9b-4f4253d04cf1 70000-0101 HUMAN OTC DRUG Leader Sterile Ultra Lubricating Eye Polyethylene glycol 400, and Propylene glycol SOLUTION/ DROPS OPHTHALMIC 20160318 OTC MONOGRAPH FINAL part349 Cardinal Health POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 400; 3 mg/mL; mg/mL N 20181231 70000-0102_377af80f-1a25-214f-e054-00144ff88e88 70000-0102 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 20160815 OTC MONOGRAPH NOT FINAL part343 Cardinal Health, Inc. ASPIRIN 81 mg/1 N 20181231 70000-0103_49bccd33-b46c-49f9-e054-00144ff88e88 70000-0103 HUMAN OTC DRUG Aspirin Aspirin TABLET, CHEWABLE ORAL 20160815 OTC MONOGRAPH NOT FINAL part343 Cardinal Health, Inc. ASPIRIN 81 mg/1 N 20181231 70000-0104_2541cdb1-bbbb-63d4-e054-00144ff88e88 70000-0104 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20160815 OTC MONOGRAPH NOT FINAL part343 Cardinal Health, Inc. ACETAMINOPHEN 325 mg/1 N 20181231 70000-0105_2544c05f-bc27-7121-e054-00144ff88e88 70000-0105 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 20160815 OTC MONOGRAPH FINAL part343 Cardinal Health, Inc. ASPIRIN 81 mg/1 N 20181231 70000-0106_256a3e24-0d6d-22c2-e054-00144ff88e88 70000-0106 HUMAN OTC DRUG Guaifenesin Guaifenesin TABLET ORAL 20160815 OTC MONOGRAPH FINAL part341 Cardinal Health, Inc. GUAIFENESIN 400 mg/1 N 20181231 70000-0107_25581be0-23f8-4767-e054-00144ff88e88 70000-0107 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 20160815 OTC MONOGRAPH FINAL part343 Cardinal Health, Inc. ASPIRIN 325 mg/1 N 20181231 70000-0108_54956c1e-dd36-4f26-9b34-88f70deb0e6b 70000-0108 HUMAN OTC DRUG Leader Ready to Use Saline Laxative Sodium Phosphate, Dibasic and Sodium Phosphate, Monobasic, Unspecified Form ENEMA RECTAL 20130219 OTC MONOGRAPH NOT FINAL part334 Cardinal Health SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 7; 19 g/118mL; g/118mL N 20181231 70000-0109_273e58f9-2394-4b72-806e-96dad96d8c4b 70000-0109 HUMAN OTC DRUG Leader Ready to Use Mineral Oil Laxative mineral oil ENEMA RECTAL 20130219 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MINERAL OIL 118 g/118mL N 20181231 70000-0110_c328c99e-7258-493a-bca3-167defce97e3 70000-0110 HUMAN OTC DRUG leader allergy relief nasal Fluticasone propionate SPRAY, METERED NASAL 20160527 ANDA ANDA207957 Cardinal Health FLUTICASONE PROPIONATE 50 ug/1 N 20191231 70000-0111_7dd7f6f3-4d4b-4418-9485-2b3672b8b53b 70000-0111 HUMAN OTC DRUG Leader First Aid Antibiotic Bacitracin Zinc, and Polymyxin B Sulfate OINTMENT TOPICAL 20160309 OTC MONOGRAPH FINAL part333B Cardinal Health BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 70000-0112_3e717cee-5c3c-4946-b25a-8d9ffa9a650c 70000-0112 HUMAN OTC DRUG Alcohol Prep isopropyl alcohol SWAB TOPICAL 20160621 OTC MONOGRAPH NOT FINAL part333A Cardinal Health ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 70000-0113_394e65a9-b206-25ad-0877-bcc0b3c0f62a 70000-0113 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 3 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20160331 NDA NDA020076 Cardinal Health NICOTINE 7 mg/24h N 20181231 70000-0114_394e65a9-b206-25ad-0877-bcc0b3c0f62a 70000-0114 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 2 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20160331 NDA NDA020076 Cardinal Health NICOTINE 14 mg/24h N 20181231 70000-0115_394e65a9-b206-25ad-0877-bcc0b3c0f62a 70000-0115 HUMAN OTC DRUG NICOTINE TRANSDERMAL SYSTEM STEP 1 NICOTINE PATCH, EXTENDED RELEASE TRANSDERMAL 20160331 NDA NDA020076 Cardinal Health NICOTINE 21 mg/24h N 20181231 70000-0116_30942732-2089-4f49-8854-fff84df7626a 70000-0116 HUMAN OTC DRUG leader nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170329 ANDA ANDA076775 Cardinal Health NICOTINE 2 mg/1 N 20181231 70000-0117_49871743-6a6d-4f76-972d-a272baaeae65 70000-0117 HUMAN OTC DRUG Leader Nicotine Nicotine Polacrilex LOZENGE ORAL 20160920 ANDA ANDA203690 Cardinal Health NICOTINE 2 mg/1 N 20181231 70000-0120_c899e35d-93ec-47a2-bfd7-82df3af6c42f 70000-0120 HUMAN OTC DRUG leader nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170329 ANDA ANDA076789 Cardinal Health NICOTINE 4 mg/1 N 20181231 70000-0121_f028c625-aa4c-4458-86df-373b9808e23e 70000-0121 HUMAN OTC DRUG Leader Nicotine Nicotine Polacrilex LOZENGE ORAL 20160927 ANDA ANDA203690 Cardinal Health NICOTINE 4 mg/1 N 20181231 70000-0122_d178414c-f81d-4cee-8d27-21a1f67289c6 70000-0122 HUMAN OTC DRUG Leader Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170323 ANDA ANDA076777 Cardinal Health NICOTINE 2 mg/1 N 20181231 70000-0123_8293664a-d4ad-49d6-aad4-b0f502334184 70000-0123 HUMAN OTC DRUG Leader Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20170321 ANDA ANDA076779 Cardinal Health NICOTINE 4 mg/1 N 20181231 70000-0124_19affc45-4242-4f81-aad9-ffcd39cd5c5c 70000-0124 HUMAN OTC DRUG Eye Itch Relief Ketotifen Fumarate SOLUTION/ DROPS OPHTHALMIC 20170118 ANDA ANDA077958 Cardinal Health KETOTIFEN FUMARATE .35 mg/mL N 20181231 70000-0125_be50bd8b-9b30-43c1-9069-c7e18e31e147 70000-0125 HUMAN OTC DRUG Loratadine Loratadine SOLUTION ORAL 20040820 ANDA ANDA076805 Cardinal Health LORATADINE 5 mg/5mL N 20181231 70000-0126_d452bd5e-3a6a-441d-a554-7a8b82020776 70000-0126 HUMAN OTC DRUG Nasal Decongestant PE Maximum Strength Phenylephrine HCl TABLET, COATED ORAL 20050114 OTC MONOGRAPH FINAL part341 Cardinal Health PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 70000-0127_0d9f6c17-c699-4df1-97af-05fee881c24f 70000-0127 HUMAN OTC DRUG Back and Body Extra Strength Aspirin, Caffeine TABLET, FILM COATED ORAL 20040412 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ASPIRIN; CAFFEINE 500; 32.5 mg/1; mg/1 N 20181231 70000-0128_6c133d12-773e-466e-aaea-d165a7d1df81 70000-0128 HUMAN OTC DRUG Nighttime Severe Cough and Cold ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE POWDER, FOR SOLUTION ORAL 20170303 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 25; 10 mg/1; mg/1; mg/1 N 20181231 70000-0129_33e4464b-a87e-4f5f-9883-58a689bcfdea 70000-0129 HUMAN OTC DRUG Maximum Strength Mucus Relief DM Dextromethorphan hydrobromide and Guaifenesin SOLUTION ORAL 20170306 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/20mL; mg/20mL N 20181231 70000-0130_9a45bf4a-435e-419f-b9b7-340d52857230 70000-0130 HUMAN OTC DRUG Zinc Cold Remedy ZINC ACETATE ANHYDROUS and ZINC GLUCONATE TABLET ORAL 20170515 UNAPPROVED HOMEOPATHIC CARDINAL HEALTH ZINC ACETATE ANHYDROUS; ZINC GLUCONATE 2; 1 [hp_X]/1; [hp_X]/1 N 20181231 70000-0131_b582a6d9-c7b9-4329-a31a-9bdd4921980c 70000-0131 HUMAN OTC DRUG Childrens Mucus and Cough Relief DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN LIQUID ORAL 20170505 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 70000-0132_0d8a009c-30b5-4f12-90bd-f8aa1110243f 70000-0132 HUMAN OTC DRUG Extra Strength Sinus Relief Nasal Decongestant Phenylephrine Hydrochloride SPRAY NASAL 20170606 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL N 20181231 70000-0133_c0c67124-dfa0-4c7d-b1d9-fc83677b99e0 70000-0133 HUMAN OTC DRUG Tussin Multi Symptom Cold CF Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI LIQUID ORAL 20170131 OTC MONOGRAPH FINAL part341 Cardinal Health (Leader) 70000 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 70000-0134_99a3475d-4cd1-4c2c-8a4e-e928706c7b67 70000-0134 HUMAN OTC DRUG Cold and Flu Nighttime Multi-symptom Acetaminophen, Dextromethorphan HBr, Doxylamine succinate CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 70000-0135_fd6a235b-151e-49e0-85eb-4fe6656120f4 70000-0135 HUMAN OTC DRUG Nasal Decongestant Maximum Strength Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 Cardinal Health PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 70000-0136_2ffbdbf2-e9be-467d-a8df-ad1a5ec5eb17 70000-0136 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET, COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70000-0137_325b5082-4a09-451f-881a-5ff6a928e6b5 70000-0137 HUMAN OTC DRUG pain reliever extra strength Acetaminophen CAPSULE, LIQUID FILLED ORAL 20161031 OTC MONOGRAPH NOT FINAL part343 Cardinal Health (Leader) 70000 ACETAMINOPHEN 500 mg/1 N 20181231 70000-0138_932fa93c-0182-471f-9931-d426118494f7 70000-0138 HUMAN OTC DRUG Flu HBP Maximum Strength Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr TABLET, FILM COATED ORAL 20050601 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 500; 2; 15 mg/1; mg/1; mg/1 N 20191231 70000-0139_8b4d3fe6-49a8-497c-9d7b-8dee280e4237 70000-0139 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine Maleate, Dextromethorphan HBr TABLET, COATED ORAL 20030503 20201031 OTC MONOGRAPH FINAL part341 Cardinal Health CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 70000-0141_82b9bdb7-b565-4a65-85b1-d7021c0b2108 70000-0141 HUMAN OTC DRUG Mucus Relief PE Sinus Congestion Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20060415 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 400; 10 mg/1; mg/1 N 20181231 70000-0142_f263595f-7303-4b60-a630-3f4e8f23b681 70000-0142 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20191231 70000-0143_ff5feea1-2c14-4128-9f42-7b0654807e1b 70000-0143 HUMAN OTC DRUG Infants Pain and Fever Acetaminophen SUSPENSION ORAL 20161031 OTC MONOGRAPH NOT FINAL part343 Cardinal Health (Leader) 70000 ACETAMINOPHEN 160 mg/5mL N 20181231 70000-0144_56d014d0-d010-4cd4-8d43-fc818953640c 70000-0144 HUMAN OTC DRUG Allergy Relief Dye-Free Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70000-0145_519b685c-a627-4c2a-bfe5-4e69e854d733 70000-0145 HUMAN OTC DRUG Menstrual Relief Maximum Strength Multi Symptom Acetaminophen, Pamabrom, Pyrilamine maleate TABLET, FILM COATED ORAL 20150113 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 70000-0146_55a961d4-0ae7-4764-a792-1dfe09d23e3e 70000-0146 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20080313 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 70000-0147_1d8286c4-d300-4d69-b1f6-7190c1902570 70000-0147 HUMAN OTC DRUG Buffered Aspirin Aspirin TABLET, FILM COATED ORAL 19900330 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ASPIRIN 325 mg/1 N 20181231 70000-0148_e9091c0b-63ef-4f69-abeb-5115efbf2a02 70000-0148 HUMAN OTC DRUG Allergy Relief All Day Cetirizine HCl TABLET ORAL 20160930 ANDA ANDA078780 Cardinal Health (Leader) 70000 CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 70000-0149_46efae21-c499-6a3e-e054-00144ff8d46c 70000-0149 HUMAN OTC DRUG Extra Strength Acetaminophen PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 20161122 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 70000-0150_463a6f4a-c852-2e89-e054-00144ff8d46c 70000-0150 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20161117 OTC MONOGRAPH NOT FINAL part343 Cardinal Health, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 70000-0151_4f0317b2-fe4f-41a2-e054-00144ff8d46c 70000-0151 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20161117 OTC MONOGRAPH NOT FINAL part343 Cardinal Health, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 70000-0152_4793aa0b-ebd8-0e5f-e054-00144ff8d46c 70000-0152 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20161128 OTC MONOGRAPH NOT FINAL part343 Cardinal Health, Inc. ACETAMINOPHEN 325 mg/1 N 20181231 70000-0153_4183148f-d75a-5d59-e054-00144ff8d46c 70000-0153 HUMAN OTC DRUG ACETAMINOPHEN ACETAMINOPHEN TABLET ORAL 20161117 OTC MONOGRAPH NOT FINAL part343 Cardinal Health, Inc. ACETAMINOPHEN 500 mg/1 N 20181231 70000-0154_66a62904-63ab-4edc-b239-5a6924e0955d 70000-0154 HUMAN OTC DRUG Alertness Aid Caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 Cardinal Health CAFFEINE 200 mg/1 N 20181231 70000-0156_dabcf451-56d7-4579-b01a-f28d4d1d6c3a 70000-0156 HUMAN OTC DRUG Leader multi symptom flu and severe cold Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl POWDER, FOR SOLUTION ORAL 20170131 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 500; 20; 10 mg/1; mg/1; mg/1 N 20181231 70000-0157_8641a71e-2889-4bd8-ab93-83da019c4c3a 70000-0157 HUMAN OTC DRUG Leader Ibuprofen PM diphenhydramine citrate, ibuprofen TABLET, FILM COATED ORAL 20161123 ANDA ANDA079113 Cardinal Health DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 70000-0158_a303396c-cc83-48e4-89f7-9c54e9889fd1 70000-0158 HUMAN OTC DRUG Leader Mucus DM Dextromethorphan HBr, Guaifenesin TABLET, EXTENDED RELEASE ORAL 20161117 ANDA ANDA091070 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 60; 1200 mg/1; mg/1 N 20181231 70000-0159_4b9b67c3-d295-47e2-b049-897da1430059 70000-0159 HUMAN OTC DRUG Tension Headache Acetaminophen, Caffeine TABLET, FILM COATED ORAL 20070117 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN; CAFFEINE 500; 65 mg/1; mg/1 N 20181231 70000-0160_d14367d8-3a1f-45dc-b82a-1b513687154d 70000-0160 HUMAN OTC DRUG Allergy Relief 4 Hour Chlorpheniramine maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 Cardinal Health CHLORPHENIRAMINE MALEATE 4 mg/1 N 20191231 70000-0161_f6348dab-d466-4335-a744-036439c96807 70000-0161 HUMAN OTC DRUG Sinus Pressure and Pain Maximum Strength Acetaminophen, Phenylephrine HCl TABLET ORAL 20050623 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 70000-0162_f1bcd2aa-e8cd-4364-87b4-c544537cdb50 70000-0162 HUMAN OTC DRUG Leader Allergy Relief D-24 Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170215 ANDA ANDA076557 Cardinal Health LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 70000-0163_6a57686b-577f-4582-8ea4-9a533db38733 70000-0163 HUMAN OTC DRUG Allergy relief-D Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170502 ANDA ANDA090922 Cardinal Health CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5; 120 mg/1; mg/1 N 20181231 70000-0164_23bb3b5b-7e45-4725-891c-7263bcadf73b 70000-0164 HUMAN OTC DRUG Pseudoephedrine Hydrochloride Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170215 ANDA ANDA075153 Cardinal Health PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1 N 20181231 70000-0167_9bf9890d-9f62-46d9-9a6c-80312a3fb0d3 70000-0167 HUMAN OTC DRUG Leader Mucus ER Max Guaifenesin TABLET, EXTENDED RELEASE ORAL 20161117 ANDA ANDA091009 Cardinal Health GUAIFENESIN 1200 mg/1 N 20181231 70000-0168_86e644c1-cf0f-4735-8d96-2e03ef6de3b8 70000-0168 HUMAN OTC DRUG Leader Cold Relief Acetaminophen, Dextromethorphan hbr, Phenylephrine hcl TABLET, FILM COATED ORAL 20161207 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 70000-0169_00621755-47b4-4291-9f88-5a386ca4e3d8 70000-0169 HUMAN OTC DRUG Leader Maximum Strength Pain Relieving Analgesic Trolamine Salicylate CREAM TOPICAL 20170831 OTC MONOGRAPH NOT FINAL part348 Cardinal Health TROLAMINE SALICYLATE 100 mg/g N 20181231 70000-0170_bddfae14-5a96-4d71-bd53-08619bff24d9 70000-0170 HUMAN OTC DRUG Leader Aspirin Aspirin TABLET, CHEWABLE ORAL 20161221 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ASPIRIN 81 mg/1 N 20181231 70000-0171_60707013-1270-4382-a891-f8928822a6fb 70000-0171 HUMAN OTC DRUG Leader All Day Pain Relief Naproxen Sodium TABLET ORAL 20161129 ANDA ANDA074661 Cardinal Health NAPROXEN SODIUM 220 mg/1 N 20181231 70000-0172_fef902ee-9088-40cf-bb60-59d880047514 70000-0172 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20161130 ANDA ANDA078682 Cardinal Health (Leader) 70000 IBUPROFEN 200 mg/1 N 20181231 70000-0173_12781171-2d59-4146-9de8-da59eb250744 70000-0173 HUMAN OTC DRUG Pain and Fever Relief Childrens Acetaminophen SUSPENSION ORAL 20161031 OTC MONOGRAPH NOT FINAL part343 Cardinal Health (Leader) 70000 ACETAMINOPHEN 160 mg/5mL N 20181231 70000-0174_6fe34d05-84a4-4254-aea6-77b52122ea18 70000-0174 HUMAN OTC DRUG LEADER Nighttime Sleep-Aid DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20170313 OTC MONOGRAPH FINAL part338 CARDINAL HEALTH DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 70000-0174_d0c5e5cb-c5ee-4bd5-aa47-846c51f121fe 70000-0174 HUMAN OTC DRUG LEADER Nighttime Sleep-Aid DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20170117 OTC MONOGRAPH FINAL part338 CARDINAL HEALTH DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 70000-0175_80db8198-9886-459f-9735-b48716245b5f 70000-0175 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20161130 ANDA ANDA072096 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 70000-0176_9f324e87-e7aa-4a57-9099-a67e7d98fc23 70000-0176 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen TABLET, COATED ORAL 20161130 ANDA ANDA072096 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 70000-0178_f9a174d3-914d-4f46-8435-e500a8bd0dc4 70000-0178 HUMAN OTC DRUG Aspirin Adult, Regimen Aspirin TABLET, FILM COATED ORAL 20110501 OTC MONOGRAPH FINAL part343 Cardinal Health ASPIRIN 81 mg/1 N 20181231 70000-0180_ef8de67d-2f05-4e3f-9ef4-abfa7889efc1 70000-0180 HUMAN OTC DRUG Leader 8HR Arthritis Pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170117 ANDA ANDA075077 Cardinal Health ACETAMINOPHEN 650 mg/1 N 20181231 70000-0181_ea6c8052-e75c-4701-ac95-8a5b8a9f94dd 70000-0181 HUMAN OTC DRUG Leader Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20161104 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL N 20181231 70000-0182_fc0631ef-413d-40db-a6e6-b00e3ba569da 70000-0182 HUMAN OTC DRUG Leader Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20161115 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 70000-0183_e7ad8d2d-01fd-40d9-a972-b2ca14cc97fb 70000-0183 HUMAN OTC DRUG Leader Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20161116 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 70000-0184_9b1a5dbe-39dd-4dbb-800c-0cef422ae7c5 70000-0184 HUMAN OTC DRUG Leader Nighttime Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20161115 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 70000-0185_616c62cd-86ab-7995-e053-2991aa0a14cf 70000-0185 HUMAN OTC DRUG Leader Ultra Strength Pain Relieving Menthol PATCH TOPICAL 20161128 OTC MONOGRAPH NOT FINAL part348 Cardinal Health, Inc. MENTHOL 50 mg/1 N 20181231 70000-0186_47947178-34b3-4515-a4f9-e274292dfb4c 70000-0186 HUMAN OTC DRUG Leader Childrens All Day Allergy cetirizine Hydrochloride SOLUTION ORAL 20170213 ANDA ANDA090254 Cardinal Health CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 70000-0187_4c99b5e3-cd79-4c54-ae37-3673c836e668 70000-0187 HUMAN OTC DRUG Leader Cough DM dextromethorphan polistirex SUSPENSION ORAL 20161205 ANDA ANDA091135 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 70000-0188_33ddf01d-fafb-487d-8827-244e57829570 70000-0188 HUMAN OTC DRUG Leader Childrens Cold and Allergy phenylephrine hcl, brompheniramine maleate SOLUTION ORAL 20161115 OTC MONOGRAPH FINAL part341 Cardinal Health PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 5; 2 mg/10mL; mg/10mL N 20181231 70000-0189_819e1bc1-4b1b-402c-8dc7-d45dd7b9c752 70000-0189 HUMAN OTC DRUG Leader Childrens Cold and Cough Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl SOLUTION ORAL 20161121 OTC MONOGRAPH FINAL part341 Cardinal Health BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/10mL; mg/10mL; mg/10mL N 20181231 70000-0190_b0dca193-ec1f-4d4b-99b4-4435cf59db8c 70000-0190 HUMAN OTC DRUG Leader Tussin dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20161129 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 70000-0191_b345152b-1074-425c-b88e-fffee79707d1 70000-0191 HUMAN OTC DRUG Leader Daytime Cold and Flu acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20161214 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 70000-0192_d38537c6-9553-4e93-a83e-11ed48c955ab 70000-0192 HUMAN OTC DRUG Leader Daytime Severe Cold and Flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SOLUTION ORAL 20161123 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL N 20181231 70000-0193_5d3772a1-4e5d-4621-bf50-0fa0acb13081 70000-0193 HUMAN OTC DRUG Leader Nighttime Cough Dextromethorphan HBr, Doxylamine succinate SOLUTION ORAL 20161129 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 30; 12.5 mg/30mL; mg/30mL N 20181231 70000-0194_8fee5c68-e6d6-4811-a49a-0c8d50772ebd 70000-0194 HUMAN OTC DRUG Leader Nighttime Severe Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl SOLUTION ORAL 20161201 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 70000-0195_3a468feb-da54-4a2c-bfce-bfe99f77efc3 70000-0195 HUMAN OTC DRUG leader childrens cough dm dextromethorphan polistirex SUSPENSION ORAL 20161115 ANDA ANDA091135 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 70000-0196_3f9bc92b-d30f-436b-a6ea-9614123440d1 70000-0196 HUMAN OTC DRUG Sinus Congestion and Pain Severe Daytime,Non-Drowsy Acetaminophen, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20050806 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20191231 70000-0197_6a9d77fa-0a0f-4a23-8184-bed003db801d 70000-0197 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, LIQUID FILLED ORAL 20161130 ANDA ANDA078682 Cardinal Health (Leader) 70000 IBUPROFEN 200 mg/1 N 20181231 70000-0200_76d82beb-c13a-4db1-9849-7a3318e66282 70000-0200 HUMAN OTC DRUG Leader Acetaminophen Acetaminophen CAPSULE, COATED ORAL 20161212 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 500 mg/1 N 20181231 70000-0201_496c2300-b971-41f6-80dd-18f30a9c3d17 70000-0201 HUMAN OTC DRUG Leader All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 20161207 ANDA ANDA074661 Cardinal Health NAPROXEN SODIUM 220 mg/1 N 20181231 70000-0202_a4fbb5a3-9ee5-41c2-b227-3073a75a4fc3 70000-0202 HUMAN OTC DRUG LOW DOSE ASPIRIN ASPIRIN TABLET, COATED ORAL 20170106 OTC MONOGRAPH NOT FINAL part343 CARDINAL HEALTH ASPIRIN 81 mg/1 N 20181231 70000-0203_063c6632-e20a-43a6-bc7e-60f34d5e33ec 70000-0203 HUMAN OTC DRUG Low Dose Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20100811 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 81 mg/1 N 20181231 70000-0204_63a2f336-3e10-4a3a-98a3-1993a8ead979 70000-0204 HUMAN OTC DRUG Leader Nasal Allergy Triamcinolone acetonide SPRAY, METERED NASAL 20161215 ANDA ANDA078104 Cardinal Health TRIAMCINOLONE ACETONIDE 55 ug/1 N 20181231 70000-0205_89fa1df8-12bc-4e40-a014-1ff7c3395b3f 70000-0205 HUMAN OTC DRUG Pain and Fever Relief Children Acetaminophen SUSPENSION ORAL 20161031 OTC MONOGRAPH NOT FINAL part343 Cardinal Health (Leader) 70000 ACETAMINOPHEN 160 mg/5mL N 20181231 70000-0206_cc6a3900-b69b-4b6c-9956-3a84649aaa1c 70000-0206 HUMAN OTC DRUG Leader Medicated Relief Patch CAMPHOR (SYNTHETIC) LEVOMENTHOL SALICYLIC ACID PATCH TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part348 CARDINAL HEALTH, INC CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 1.2; 5.7; 6.3 1/1; 1/1; 1/1 E 20171231 70000-0207_602bbb7e-37a0-52b1-e053-2991aa0a5fe1 70000-0207 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20170113 OTC MONOGRAPH FINAL part341 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70000-0208_149bdc66-cc75-4f31-a2cb-c3cdbbe18225 70000-0208 HUMAN OTC DRUG Leader Ultra Strength Muscle Rub Topical Analgesic Camphor (Synthetic), Menthol, Unspecified Form, and Methyl Salicylate CREAM TOPICAL 20170524 OTC MONOGRAPH NOT FINAL part348 Cardinal Health CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g N 20181231 70000-0211_1e969783-9e66-47f4-9d11-6c1d048bed19 70000-0211 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl TABLET, FILM COATED ORAL 20050628 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 N 20191231 70000-0212_aed13b8e-3627-4b99-8592-2a4c32088c68 70000-0212 HUMAN OTC DRUG Leader Allergy Relief fexofenadine hcl TABLET, FILM COATED ORAL 20161227 ANDA ANDA076447 Cardinal Health FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 70000-0213_8da4b2bd-34b5-4f8c-8383-ed4fa70bd9ab 70000-0213 HUMAN OTC DRUG Leader Allergy Relief Loratadine TABLET ORAL 20161209 ANDA ANDA076301 Cardinal Health LORATADINE 10 mg/1 N 20181231 70000-0214_b11080bf-5916-497d-966a-eb13191a6b87 70000-0214 HUMAN OTC DRUG Leader Childrens All Day Allergy Cetirizine HCl SOLUTION ORAL 20170228 ANDA ANDA204226 Cardinal Health CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 70000-0215_6e69ba49-a487-445b-b5f3-5e468d86ac44 70000-0215 HUMAN OTC DRUG Leader Childrens all day allergy Cetirizine HCl SOLUTION ORAL 20170210 ANDA ANDA204226 Cardinal Health CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 70000-0216_7c007611-7b9f-4229-9761-f28a3c733bdc 70000-0216 HUMAN OTC DRUG Leader Allerhist Clemastine fumarate TABLET ORAL 20170111 ANDA ANDA074512 Cardinal Health CLEMASTINE FUMARATE 1.34 mg/1 N 20181231 70000-0217_6e55f408-2c1d-47bc-a8f9-62763bdc411b 70000-0217 HUMAN OTC DRUG LORATADINE LORATADINE CAPSULE, LIQUID FILLED ORAL 20170119 ANDA ANDA206214 Cardinal Health LORATADINE 10 mg/1 N 20181231 70000-0218_230eb365-70bc-47c0-bbc1-a292b1d5195b 70000-0218 HUMAN OTC DRUG Adult Aspirin Regimen Low Dose Aspirin TABLET, COATED ORAL 20140725 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ASPIRIN 81 mg/1 N 20181231 70000-0221_2f42629f-de65-44a9-aace-4d3bb710e991 70000-0221 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET, COATED ORAL 20020325 OTC MONOGRAPH NOT FINAL part334 Cardinal Health BISACODYL 5 mg/1 N 20191231 70000-0223_c4814524-0f4c-4351-a431-5b4b6431fd28 70000-0223 HUMAN OTC DRUG Leader Hemorrhoidal cocoa butter, phenylephrine HCl SUPPOSITORY RECTAL 20170117 OTC MONOGRAPH FINAL part346 Cardinal Health COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 2211; 6.5 mg/1; mg/1 N 20181231 70000-0224_78f0d543-3ce4-4cc8-868e-6ef3b84855cc 70000-0224 HUMAN OTC DRUG Leader Anti Diarrheal loperamide HCl SUSPENSION ORAL 20170119 ANDA ANDA091292 Cardinal Health LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL N 20181231 70000-0225_9079a59b-a158-4e77-a104-547959f7ba78 70000-0225 HUMAN OTC DRUG Leader Anti Diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20170117 ANDA ANDA075232 Cardinal Health LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 70000-0228_0641793c-ebaf-4496-addd-5077426db9be 70000-0228 HUMAN OTC DRUG STIMULANT LAXATIVE BISACODYL TABLET, DELAYED RELEASE ORAL 20170124 OTC MONOGRAPH NOT FINAL part334 CARDINAL HEALTH BISACODYL 5 mg/1 N 20181231 70000-0229_946025c1-c760-4f6a-9ef7-85d43269e655 70000-0229 HUMAN OTC DRUG DOCUSATE SODIUM - SENNOSIDES DOCUSATE SODIUM - SENNOSIDES TABLET, FILM COATED ORAL 20170127 OTC MONOGRAPH NOT FINAL part334 CARDINAL HEALTH DOCUSATE SODIUM; SENNOSIDES 50; 8.6 mg/1; mg/1 N 20181231 70000-0230_dc81f62b-4533-4ade-8ad6-47fc66ad0aa1 70000-0230 HUMAN OTC DRUG Anti-Diarrheal Loperamide HCl CAPSULE, LIQUID FILLED ORAL 20170131 NDA NDA021855 Cardinal Health (Leader) 70000 LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 70000-0232_a300ec55-4989-704b-413a-0339ac503430 70000-0232 HUMAN OTC DRUG Acid Reducer Omeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20170307 ANDA ANDA078878 Cardinal Health OMEPRAZOLE MAGNESIUM 20 mg/1 N 20181231 70000-0237_124ab544-a5ea-4c7f-b1a6-09d6ca68c85b 70000-0237 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength Aspirin TABLET, DELAYED RELEASE ORAL 20170221 OTC MONOGRAPH FINAL part343 CARDINAL HEALTH ASPIRIN 325 mg/3251 N 20181231 70000-0238_8c45e3c3-e610-4b56-9d81-e5e8758477fd 70000-0238 HUMAN OTC DRUG Leader Ultra Strength Muscle Rub Camphor, Menthol, and Methyl Salicylate CREAM TOPICAL 20170816 OTC MONOGRAPH NOT FINAL part348 Cardinal Health, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 40; 100; 300 mg/g; mg/g; mg/g N 20181231 70000-0239_5975c324-2906-4e71-9b88-2e772d9fbfde 70000-0239 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20170421 ANDA ANDA076359 Cardinal Health IBUPROFEN 100 mg/1 N 20181231 70000-0240_bc52ecd3-818e-4cca-8241-d53981e9d382 70000-0240 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen TABLET, CHEWABLE ORAL 20170420 ANDA ANDA076359 Cardinal Health IBUPROFEN 100 mg/1 N 20181231 70000-0241_16326945-97af-4f03-ab90-67614ed345a8 70000-0241 HUMAN OTC DRUG Leader Maximum Strength Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20170201 UNAPPROVED DRUG OTHER Cardinal Health PHENAZOPYRIDINE HYDROCHLORIDE 97.5 mg/1 N 20181231 70000-0242_af84c11f-b49a-49b3-a2b8-5d6e84b048fe 70000-0242 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70000-0243_bfbd317e-86db-4067-b979-8e1d75eb14e2 70000-0243 HUMAN OTC DRUG Leader Urinary Pain Relief PHENAZOPYRIDINE HYDROCHLORIDE TABLET ORAL 20130701 UNAPPROVED DRUG OTHER Cardinal Health PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1 N 20181231 70000-0244_6a9fcc92-bae6-41db-8071-8c8dfb4c7dd8 70000-0244 HUMAN OTC DRUG Sleep Aid Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70000-0245_ad696962-5e46-4133-92ae-27453965819f 70000-0245 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine hydrochloride SOLUTION ORAL 20170504 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 70000-0245_ed10dcf2-dac3-4902-b8fb-f157618f9d90 70000-0245 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine hydrochloride SOLUTION ORAL 20170502 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 70000-0246_eb990749-9405-432d-a370-90d8353a8648 70000-0246 HUMAN OTC DRUG Childrens Dye Free Allergy Relief Diphenhydramine hydrochloride SOLUTION ORAL 20170502 OTC MONOGRAPH FINAL part341 CARDINAL HEALTH DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 70000-0247_b74a8baa-c7a2-4eed-8202-888d8ba829b9 70000-0247 HUMAN OTC DRUG Leader Migraine Relief Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 20170216 ANDA ANDA075794 Cardinal Health ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 70000-0248_c6ec9e60-e7fe-4bdd-8834-b84538177b81 70000-0248 HUMAN OTC DRUG Leader Ibuprofen PM Diphenhydramine citrate, Ibuprofen TABLET, COATED ORAL 20170322 ANDA ANDA079113 Cardinal Health DIPHENHYDRAMINE CITRATE; IBUPROFEN 38; 200 mg/1; mg/1 N 20181231 70000-0249_374b2cc8-dd2f-4286-8a7f-61fc0889b368 70000-0249 HUMAN OTC DRUG Sleep Aid Nighttime Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 Cardinal Health DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 70000-0250_ae587536-733e-4b50-a9a9-cb15ae8f0d6f 70000-0250 HUMAN OTC DRUG Motion Sickness Relief Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 Cardinal Health DIMENHYDRINATE 50 mg/1 N 20181231 70000-0251_280e0b67-092b-41c6-830a-9009992a993e 70000-0251 HUMAN OTC DRUG Mucus Relief Chest Congestion Guaifenesin TABLET ORAL 20091005 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 200 mg/1 N 20181231 70000-0252_b7c1c7fe-bfb1-43f2-9e62-386605512797 70000-0252 HUMAN OTC DRUG Childrens Loratadine Sugar Free Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 Cardinal Health LORATADINE 5 mg/5mL N 20181231 70000-0253_ec28aba0-e7e3-4a78-a660-ca8f46c025b2 70000-0253 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 19960210 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ASPIRIN 325 mg/1 N 20181231 70000-0255_8d7d9685-bf05-4096-8ea1-3fc2c0c24bbe 70000-0255 HUMAN OTC DRUG Leader Heartburn Treatment Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170829 ANDA ANDA207193 Cardinal Health ESOMEPRAZOLE 20 mg/1 N 20181231 70000-0258_f6550cb9-6b4a-438a-ad28-ab3246b4e7b1 70000-0258 HUMAN OTC DRUG Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine TABLET, FILM COATED ORAL 19921117 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 70000-0259_237915bb-a3d0-45fc-ae41-966e187ecd64 70000-0259 HUMAN OTC DRUG Ibuprofen Childrens Ibuprofen SUSPENSION ORAL 20170915 ANDA ANDA074916 Cardinal Health, Inc. IBUPROFEN 100 mg/5mL N 20181231 70000-0260_22fd39f2-1320-429e-bc7d-195a61fda27d 70000-0260 HUMAN OTC DRUG Leader Ice Blue Analgesic Menthol, Unspecified Form GEL TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part348 Cardinal Health MENTHOL, UNSPECIFIED FORM 20 mg/g N 20181231 70000-0261_359f70d5-d3f3-4e0e-a507-5443efa5faf7 70000-0261 HUMAN OTC DRUG Leader Childrens Mucus Relief dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20170322 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 70000-0262_53d5276f-d73d-4510-9142-b10a56e32d19 70000-0262 HUMAN OTC DRUG Leader Ibuprofen Ibuprofen SUSPENSION ORAL 20170501 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL N 20181231 70000-0263_1ef9c06e-4a66-48ec-8619-b4f092212ef7 70000-0263 HUMAN OTC DRUG LEADER CHILDRENS IBUPROFEN Ibuprofen SUSPENSION ORAL 20170328 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL N 20181231 70000-0264_187f6ad2-920d-423f-ae5e-c8f344367499 70000-0264 HUMAN OTC DRUG leader Ibuprofen Ibuprofen SUSPENSION ORAL 20170405 ANDA ANDA074937 Cardinal Health IBUPROFEN 100 mg/5mL N 20181231 70000-0265_4a4d2363-1f05-18a4-e054-00144ff88e88 70000-0265 HUMAN OTC DRUG Cherry Cough Drop Menthol LOZENGE ORAL 20170307 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 5.8 mg/1 N 20181231 70000-0266_4a4d76a2-8c48-0f3a-e054-00144ff88e88 70000-0266 HUMAN OTC DRUG Honey Lemon Cough Drop Menthol LOZENGE ORAL 20170307 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 7.5 mg/1 N 20181231 70000-0267_4a4f3257-38fa-6364-e054-00144ff88e88 70000-0267 HUMAN OTC DRUG SF Honey Lemon Cough Drop Menthol LOZENGE ORAL 20170307 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 7.5 mg/1 N 20181231 70000-0268_4a3d9f5c-520d-5a32-e054-00144ff8d46c 70000-0268 HUMAN OTC DRUG Menthol Cough Drop Menthol LOZENGE ORAL 20170307 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 5.4 mg/1 N 20181231 70000-0269_4a4e5287-a8d3-2b5b-e054-00144ff8d46c 70000-0269 HUMAN OTC DRUG SF Menthol Cough Drop Menthol LOZENGE ORAL 20170307 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 5.8 mg/1 N 20181231 70000-0270_612c4393-c088-4238-a80e-2c1939643feb 70000-0270 HUMAN OTC DRUG Leader Sinus Wash Saline Refills SODIUM BICARBONATE, SODIUM CHLORIDE POWDER, FOR SOLUTION NASAL 20130401 UNAPPROVED DRUG OTHER Cardinal Health 414, LLC SODIUM BICARBONATE; SODIUM CHLORIDE 22.2; 77.8 mg/100mg; mg/100mg N 20181231 70000-0275_beaff5b1-6a9a-4c28-be44-2f6d6e9e5390 70000-0275 HUMAN OTC DRUG Medicated Chest Rub JELLY TOPICAL 20170401 OTC MONOGRAPH FINAL part341 Cardinal Health CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 kg/g; kg/g; kg/g N 20181231 70000-0277_e73c072b-617e-45a0-a684-f71173839d91 70000-0277 HUMAN OTC DRUG Sore Throat Relief Cherry Phenol SPRAY ORAL 20170331 OTC MONOGRAPH NOT FINAL part356 Cardinal Health (Leader) 70000 PHENOL 1.4 g/100mL N 20181231 70000-0278_a158575e-225b-4049-8592-9952d52f1817 70000-0278 HUMAN OTC DRUG Mucus Relief DM Cough Maximum Strength Dextromethorphan HBr and Guaifenesin TABLET, FILM COATED ORAL 20051231 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 N 20181231 70000-0281_520771f6-b644-437f-a437-b64e90264818 70000-0281 HUMAN OTC DRUG Leader Sinus and Cold-D Naproxen sodium, Pseudoephedrine HCl TABLET, FILM COATED ORAL 20170607 ANDA ANDA076518 Cardinal Health NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 220; 120 mg/1; mg/1 N 20181231 70000-0282_8bc389eb-4c3b-4785-bcaa-1f12032633fa 70000-0282 HUMAN OTC DRUG Leader Mucus Relief Sever Cold Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20170628 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 70000-0283_a1b6da08-b8b0-4132-9ba5-8d8145f4ec93 70000-0283 HUMAN OTC DRUG Leader severe cold and flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20170603 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 70000-0284_8db10497-19bf-4372-82c3-9362e036af48 70000-0284 HUMAN OTC DRUG Leader Mucus Relief Cold Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20170706 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 70000-0285_c8925791-4426-4695-bf21-cfd24374b2ce 70000-0285 HUMAN OTC DRUG Leader sinus relief Acetaminophen, guaifenesin, phenylephrine HCl TABLET, FILM COATED ORAL 20170603 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 70000-0286_0d4ad62b-ec28-41d0-82a4-3ba142f7b4fa 70000-0286 HUMAN OTC DRUG Leader mucus relief cold and sinus Acetaminophen, guaifenesin, phenylephrine HCl TABLET, COATED ORAL 20170811 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 70000-0287_e61577cb-1b5d-43de-b0dd-b2c564bd7504 70000-0287 HUMAN OTC DRUG Leader Flu and Severe Cold and Cough Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride POWDER, FOR SOLUTION ORAL 20170412 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 10 mg/1; mg/1; mg/1 N 20181231 70000-0288_ed88bd38-cd7a-4e89-8121-04ac96104222 70000-0288 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 70000-0289_b1860787-1a0e-4ee2-8893-a9832db04509 70000-0289 HUMAN OTC DRUG Severe Cold and Flu Maximum Strength, Daytime, Non-Drowsy Acetaminophen. Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED ORAL 20140227 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1 N 20181231 70000-0290_4a4e9bab-e00d-39ff-e054-00144ff88e88 70000-0290 HUMAN OTC DRUG SF Cherry Cough Drop Menthol LOZENGE ORAL 20170307 OTC MONOGRAPH FINAL part341 Cardinal Health MENTHOL 5.8 mg/1 N 20181231 70000-0291_538e31a9-ef74-4419-8e29-871a5425bdb9 70000-0291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 70000-0292_a1e9ba45-3f6e-4a34-86a8-dbf1931e6c3d 70000-0292 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 19990301 ANDA ANDA075139 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 70000-0298_e565d01f-04c7-4ff1-a40c-746b54583460 70000-0298 HUMAN OTC DRUG leader infants ibuprofen Ibuprofen SUSPENSION/ DROPS ORAL 20170607 ANDA ANDA075217 Cardinal Health IBUPROFEN 50 mg/1.25mL N 20181231 70000-0299_2aee0c28-9678-42ca-9b60-37fc23b8412a 70000-0299 HUMAN OTC DRUG Leader Tussin Guaifenesin SOLUTION ORAL 20170606 OTC MONOGRAPH FINAL part341 Cardinal Health GUAIFENESIN 200 mg/10mL N 20181231 70000-0300_a100c762-5e88-4c67-9d99-58a204e91bde 70000-0300 HUMAN OTC DRUG leader tussin dm Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20170607 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 70000-0301_327c5321-f28f-4034-8d8c-44e2fa2396d9 70000-0301 HUMAN OTC DRUG leader tussin dm Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20170721 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 70000-0302_a07b70d0-3842-4ea6-abb4-95b4638d5e55 70000-0302 HUMAN OTC DRUG Leader Cough DM dextromethorphan polistirex SUSPENSION, EXTENDED RELEASE ORAL 20170606 ANDA ANDA091135 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL N 20181231 70000-0303_a51524fd-5229-4529-955e-a762fb6cc4a7 70000-0303 HUMAN OTC DRUG Leader Headache Relief PM Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED ORAL 20170509 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 70000-0304_e0921622-f3b3-4a65-ba64-0fef82c36b9b 70000-0304 HUMAN OTC DRUG Leader Cold and Flu Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20170424 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 70000-0305_e829b626-b428-4597-8b0a-dc45b9f83867 70000-0305 HUMAN OTC DRUG Pain and Fever Relief Childrens Acetaminophen SUSPENSION ORAL 20170430 OTC MONOGRAPH NOT FINAL part343 Cardinal Health (Leader) 70000 ACETAMINOPHEN 160 mg/5mL N 20181231 70000-0306_cf6e226f-459d-458d-b8cf-2051e7d8a52c 70000-0306 HUMAN OTC DRUG Leader 8 HR Muscle Aches and Pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170505 ANDA ANDA075077 Cardinal Health ACETAMINOPHEN 650 mg/1 N 20181231 70000-0307_b8ef9934-4877-4de2-9c28-1cf96c48cb8c 70000-0307 HUMAN OTC DRUG leader ibuprofen ibuprofen SUSPENSION ORAL 20170601 ANDA ANDA075217 Cardinal Health IBUPROFEN 50 mg/1.25mL N 20181231 70000-0308_5b67c2eb-2145-418a-9418-f8ac915704eb 70000-0308 HUMAN OTC DRUG leader ibuprofen Ibuprofen TABLET, COATED ORAL 20170601 ANDA ANDA077349 Cardinal Health IBUPROFEN 200 mg/1 N 20181231 70000-0309_0e52c1a6-8d5a-475c-8b79-43b0ecf45ff6 70000-0309 HUMAN OTC DRUG Chewable Acetaminophen Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050128 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/1 N 20181231 70000-0310_d3ee3485-945f-4f40-bdfd-b65474216c5d 70000-0310 HUMAN OTC DRUG Chewable Acetaminophen Childrens Acetaminophen TABLET, CHEWABLE ORAL 20050225 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 160 mg/1 N 20181231 70000-0311_86f3e0c9-c332-4756-aa76-fd346bdeff29 70000-0311 HUMAN OTC DRUG Leader Sleep Aid Diphenhydramine HCl SOLUTION ORAL 20170804 OTC MONOGRAPH FINAL part338 Cardinal Health DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20181231 70000-0312_051eab9d-61b1-4c15-a3f2-939a1cc44daf 70000-0312 HUMAN OTC DRUG Acetaminophen Extra Strength Acetaminophen TABLET ORAL 20040510 OTC MONOGRAPH NOT FINAL part343 Cardinal Health ACETAMINOPHEN 500 mg/1 N 20181231 70000-0313_fc1e5e59-d547-4a35-8d11-0018d0c1a449 70000-0313 HUMAN OTC DRUG Leader Tussin CF Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl SOLUTION ORAL 20170605 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 70000-0314_81382f90-43db-4ca6-ba30-2f993e9a1ff8 70000-0314 HUMAN OTC DRUG Sinus and Headache Daytime, Non-Drowsy Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20050726 OTC MONOGRAPH FINAL part341 Cardinal Health ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 70000-0315_a1052836-49d1-47f2-988f-f91cec0d794e 70000-0315 HUMAN OTC DRUG Leader Miconazole 1 Miconazole nitrate KIT 20170712 ANDA ANDA079114 Cardinal Health N 20181231 70000-0317_e56cfb63-efb7-92b1-e956-802ab849f343 70000-0317 HUMAN OTC DRUG LORATADINE Loratadine TABLET ORAL 20160622 ANDA ANDA076471 Cardinal Health LORATADINE 10 mg/1 N 20181231 70000-0318_2b3d87c6-3342-4ff0-9282-18d5713c4eae 70000-0318 HUMAN OTC DRUG Magnesium Citrate Magnesium citrate LIQUID ORAL 19890621 OTC MONOGRAPH NOT FINAL part334 Cardinal Health MAGNESIUM CITRATE 1.745 g/29.6mL N 20181231 70000-0319_b43c37aa-f249-40e3-9a59-6f6e53dc19a9 70000-0319 HUMAN OTC DRUG Leader Tussin DM Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20171101 OTC MONOGRAPH FINAL part341 Cardinal Health DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 70000-0321_ea7670fb-4c37-47c3-bb1f-eb7342eb9acd 70000-0321 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Powder Miconazole Nitrate Talc Free POWDER TOPICAL 20171020 OTC MONOGRAPH FINAL part333C Cardinal Health MICONAZOLE NITRATE 2.6 g/130g N 20181231 70000-0322_6c75af87-a157-4705-ba65-d802dea49921 70000-0322 HUMAN OTC DRUG Tolnafate Tolnaftate Powder Spray - Talc Free AEROSOL, SPRAY TOPICAL 20171020 OTC MONOGRAPH FINAL part333C Cardinal Health TOLNAFTATE 1.3 g/130g N 20181231 70000-0323_8adcf955-15ef-4074-99a1-d7a605fa14a2 70000-0323 HUMAN OTC DRUG Miconazole Nitrate Anti-fungal Powder Miconazole Nitrate Talc Free POWDER TOPICAL 20171020 OTC MONOGRAPH FINAL part333C Cardinal Health MICONAZOLE NITRATE 1.42 g/71g N 20181231 70000-0324_2ce7607a-3c8b-4132-b3c2-79d703799b3f 70000-0324 HUMAN OTC DRUG Cough and Cold HBP Chlorpheniramine maleate, Dextromethorphan HBr TABLET, FILM COATED ORAL 20170515 OTC MONOGRAPH FINAL part341 Cardinal Health CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 N 20181231 70000-0354_b07b97c4-8c38-4718-b272-e83b1f32f86c 70000-0354 HUMAN OTC DRUG Leader stomach relief Bismuth subsalicylate SUSPENSION ORAL 20180205 OTC MONOGRAPH FINAL part335 Cardinal Health BISMUTH SUBSALICYLATE 1050 mg/30mL N 20191231 70000-0355_a2e3b8cc-8c9e-4aaa-9f51-573be27899af 70000-0355 HUMAN OTC DRUG Leader Stomach Relief Bismuth subsalicylate SUSPENSION ORAL 20180202 OTC MONOGRAPH FINAL part335 Cardinal Health BISMUTH SUBSALICYLATE 525 mg/30mL N 20191231 70003-300_7978f03e-fa98-4550-b72b-393be98fbad8 70003-300 HUMAN PRESCRIPTION DRUG NITROGLYCERIN LINGUAL Nitroglycerin SPRAY ORAL 20160301 NDA NDA018705 Jacksonville Pharmaceuticals, Inc. NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 70005-001_44f9f277-7a42-4b14-850e-a88627a64126 70005-001 HUMAN OTC DRUG Allergy Relief Diphenhydramine HCl TABLET ORAL 20160111 OTC MONOGRAPH FINAL part341 We Care Distributor Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70005-002_e1f74469-b387-4845-b2bb-49dc302632d4 70005-002 HUMAN OTC DRUG Chronic Pain/Fever Relief Aspirin Delayed Release Tablets, 81 mg TABLET ORAL 20160209 OTC MONOGRAPH FINAL part343 We Care Distributor Inc. ASPIRIN 81 mg/1 N 20181231 70005-003_364c0bbe-0588-4ef9-933e-3bee49517e42 70005-003 HUMAN OTC DRUG DAYTIME COLD AND FLU Acetaminophen, Dextromethorphan HBr and Phenylephrine HCl 325 mg, 10 mg and 5 mg CAPSULE, LIQUID FILLED ORAL 20160215 OTC MONOGRAPH FINAL part341 We Care Distributor Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 70005-004_6f3ac469-ec4b-4c97-99b8-f192ca526847 70005-004 HUMAN OTC DRUG Headache Relief Acetaminophen, Aspirin, and Caffeine TABLET ORAL 20160209 OTC MONOGRAPH NOT FINAL part343 We Care Distributor Inc. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 70005-005_abbdacdc-1646-45bf-99ed-9e3fd94b78b6 70005-005 HUMAN OTC DRUG NIGHTTIME COLD AND FLU Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate 325 mg, 15 mg and 6.25 mg CAPSULE, LIQUID FILLED ORAL 20160217 OTC MONOGRAPH FINAL part341 We Care Distributor Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 70005-006_af3f90ed-b08c-450e-80e0-2a477a5ca095 70005-006 HUMAN OTC DRUG Acetaminophen Tablets, 500 mg Extra Strength Acetaminophen TABLET ORAL 20160208 OTC MONOGRAPH NOT FINAL part343 We Care Distributors Inc. ACETAMINOPHEN 500 mg/1 N 20181231 70005-007_3cb38802-81a3-427a-8b50-54c4290cb6d8 70005-007 HUMAN OTC DRUG Pain Relief PM Acetaminophen and Diphenhydramine Hydrochloride TABLET ORAL 20160209 OTC MONOGRAPH NOT FINAL part343 We Care Distributor Inc. ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 70005-008_b3b4bb86-ef6b-4377-984c-583fd64e7536 70005-008 HUMAN OTC DRUG All Day Pain Relief Naproxen Sodium Tablets, 220 mg TABLET ORAL 20110930 ANDA ANDA091353 We Care Distributor Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 70005-009_0a2f27ca-98e4-44f5-b812-b3803f61f762 70005-009 HUMAN OTC DRUG Fast Pain Relief Ibuprofen TABLET, COATED ORAL 20151202 OTC MONOGRAPH NOT FINAL part343 We Care Distributor Inc. IBUPROFEN 200 mg/1 N 20181231 70005-011_d27b1667-a611-4189-adc1-cc0c6ed91a1d 70005-011 HUMAN OTC DRUG Menstrual Relief Acetaminophen, Caffeine and Pyrilamine Maleate 500 mg, 60 mg and 15 mg TABLET ORAL 20160215 OTC MONOGRAPH NOT FINAL part343 We Care Distributor Inc. ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 15; 60 mg/1; mg/1; mg/1 N 20181231 70005-012_19ee0db7-17c4-4ca6-b07d-e337a5837032 70005-012 HUMAN OTC DRUG SINUS CONGESTION AND PAIN RELIEF Acetaminophen, Guaifenesin and Phenylephrine HCl 325 mg, 200 mg and 5 mg TABLET, COATED ORAL 20160215 OTC MONOGRAPH NOT FINAL part343 We Care Distributor Inc. ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 N 20181231 70005-014_75aaf9f0-4abc-4321-9e6f-0838c362f794 70005-014 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine HCl TABLET ORAL 20160204 OTC MONOGRAPH FINAL part341 We Care Distributor Inc DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70005-015_5d23093e-30d7-488d-8df2-0ec78055321b 70005-015 HUMAN OTC DRUG STOOL SOFTENER Docusate Sodium 100 mg CAPSULE, LIQUID FILLED ORAL 20160307 OTC MONOGRAPH NOT FINAL part334 We Care Distributor Inc. DOCUSATE SODIUM 200 mg/1 N 20181231 70005-016_b2b627ad-deee-4e8e-b2b2-686d97323782 70005-016 HUMAN OTC DRUG SENNA-S Senna and Docusate Sodium Tablets, 8.6 mg TABLET, COATED ORAL 20160307 OTC MONOGRAPH NOT FINAL part334 We Care Distributor Inc. SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20181231 70005-019_7bd332d3-ce1c-43a8-b913-b7f978501515 70005-019 HUMAN OTC DRUG Gas Relief Simethicone 180 mg CAPSULE, LIQUID FILLED ORAL 20091001 OTC MONOGRAPH FINAL part332 We Care Distributor Inc. DIMETHICONE 180 mg/1 N 20181231 70005-020_cc191c28-7fdf-41b0-8c30-46e358af0caa 70005-020 HUMAN OTC DRUG ALERTNESS AID Caffeine Tablets, 200 mg TABLET, COATED ORAL 20160307 OTC MONOGRAPH FINAL part340 We Care Distributor Inc. CAFFEINE 200 mg/1 N 20181231 70005-034_e04513ed-8659-4749-9ca7-12c4459c3316 70005-034 HUMAN OTC DRUG Ear Relief Ear Drops Chamomilla, Mercurius Solubilis, and Sulphur SOLUTION AURICULAR (OTIC) 20160923 UNAPPROVED HOMEOPATHIC We Care Distributor Inc. CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR 10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL N 20181231 70005-035_35dbe896-ac5e-4810-9597-80f5e284d001 70005-035 HUMAN OTC DRUG Sore Throat Phenol SPRAY ORAL 20160923 OTC MONOGRAPH NOT FINAL part356 We Care Distributor Inc. PHENOL 1.4 g/100mL N 20181231 70005-036_6b19bc87-765d-4821-86a3-c42c4faea4f1 70005-036 HUMAN OTC DRUG Allergy Childrens Diphenhydramine Hydrochloride LIQUID ORAL 20160621 OTC MONOGRAPH FINAL part341 We Care Distributors Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 70005-038_f19d2b1b-74ac-43b3-9a83-56dba094c7d3 70005-038 HUMAN OTC DRUG Nasal Oxymetazoline Hydrochloride SPRAY NASAL 20160823 OTC MONOGRAPH FINAL part341 We Care Distributor Inc. OXYMETAZOLINE HYDROCHLORIDE 5 g/100mL N 20181231 70005-040_4d3f87a4-cd9e-49a4-8b0b-464cbcc7673e 70005-040 HUMAN OTC DRUG Childrens Acetaminophen Oral Suspension Grape Flavor Acetaminophen SUSPENSION ORAL 20160926 OTC MONOGRAPH NOT FINAL part343 We Care Distributor Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 70005-041_813fae05-a5b9-40a6-83fa-5146a2625445 70005-041 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen SUSPENSION ORAL 20160817 OTC MONOGRAPH NOT FINAL part343 We Care Distributors Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 70005-044_dc3abb69-1bf1-4b3e-8160-05b0cf619290 70005-044 HUMAN OTC DRUG Cough Suppressant and Expectorant DM Tussin DM LIQUID ORAL 20160629 OTC MONOGRAPH FINAL part341 We Care Distributor Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL N 20181231 70005-045_04f521a6-ac30-4eb5-8d9c-5ce15fbb98dc 70005-045 HUMAN OTC DRUG Day Time Cold and Flu cold and flu multi symptom relief acetaminophen, dextromethorphan Hbr, Phenylephrine HCl SOLUTION ORAL 20160630 OTC MONOGRAPH FINAL part341 We Care Distributor Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 70005-046_ca4692d7-87cd-43a9-ab0e-d065739b7ace 70005-046 HUMAN OTC DRUG nite time cold flu relief acetaminophen,dextromethorphan HBr, doxylamine succinate LIQUID ORAL 20160810 OTC MONOGRAPH FINAL part341 We Care Distributor Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 70005-047_74ba1350-728d-4035-9502-c823df2be69e 70005-047 HUMAN OTC DRUG Pink Bismuth Bismuth subsalicylate LIQUID ORAL 20161025 OTC MONOGRAPH FINAL part335 We Care Distributor Inc. BISMUTH SUBSALICYLATE 262 mg/15mL N 20181231 70005-048_40bc5371-feeb-4620-8e7d-5c8e165d5257 70005-048 HUMAN OTC DRUG Childrens Acetaminophen Liquid Acetaminophen LIQUID ORAL 20161011 OTC MONOGRAPH NOT FINAL part343 We Care Distributor Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 70005-049_4f1786d3-3dc7-4e27-90c6-7b543e81c131 70005-049 HUMAN OTC DRUG Childrens Acetaminophen Acetaminophen ELIXIR ORAL 20161013 OTC MONOGRAPH NOT FINAL part343 We Care Distributor Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 70006-500_903ff975-f5ff-4cd3-9f0c-43d786bf397e 70006-500 HUMAN OTC DRUG VIAMED Alcohol Prep Pad ALCOHOL SWAB TOPICAL 20150910 OTC MONOGRAPH NOT FINAL part333E Rece International Corp ALCOHOL 70 g/100g N 20181231 70007-300_b20938e1-e87f-4bf6-8770-2649ef261371 70007-300 HUMAN PRESCRIPTION DRUG NITROLINGUAL Nitroglycerin SPRAY ORAL 20160301 NDA NDA018705 Espero Pharmaceuticals, Inc. NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 70007-400_0d5ca128-aec5-41d3-9b2e-bf1c98a76f40 70007-400 HUMAN PRESCRIPTION DRUG GONITRO nitroglycerin POWDER SUBLINGUAL 20160701 NDA NDA208424 Espero Pharmaceuticals, Inc. NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 70012-101_11bc82f1-1002-4cab-bdd9-ee3f1d2329ad 70012-101 HUMAN OTC DRUG 1st Date antibacterial Deodorant (White) Triclocarban SOAP TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part333E Guilin Share Friend Daily Use Chemical Co.,Ltd TRICLOCARBAN .3 g/100g E 20171231 70012-102_3555ee80-2a8e-45c7-9585-af4373473ded 70012-102 HUMAN OTC DRUG 1st Date antibacterial Deodorant (Gold) Triclocarban SOAP TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part333E Guilin Share Friend Daily Use Chemical Co.,Ltd TRICLOCARBAN .3 g/100g E 20171231 70012-103_ce9b21bf-dfe8-455b-80c9-5b76fe585bd5 70012-103 HUMAN OTC DRUG 1st Date antibacterial Deodorant (Green) Triclocarban SOAP TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part333E Guilin Share Friend Daily Use Chemical Co.,Ltd TRICLOCARBAN .3 g/100g E 20171231 70013-302_2c9edc9c-3592-0cf6-e054-00144ff88e88 70013-302 HUMAN OTC DRUG Bevoline benzoyl peroxide LOTION TOPICAL 20160222 OTC MONOGRAPH FINAL part333D Skin Divine Inc. BENZOYL PEROXIDE 2.5 g/100mL E 20171231 70014-0703_211fc36c-ca85-4caa-e054-00144ff8d46c 70014-0703 HUMAN OTC DRUG Beam Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20151105 OTC MONOGRAPH FINAL part355 Beam SODIUM FLUORIDE 1.1 mg/g N 20181231 70015-645_48a91b6c-d99e-4a92-e054-00144ff8d46c 70015-645 HUMAN OTC DRUG Oxy Rub Pain Relief MENTHOL CREAM TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Healthy Directions MENTHOL 12.5 mg/g N 20181231 70015-650_b8d79ecd-b1c0-461d-829b-2913dc48446f 70015-650 HUMAN OTC DRUG OxyRub Max Pain Relief Cream, 2oz Menthol, Methyl Salicylate CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Healthy Directions, LLC MENTHOL; METHYL SALICYLATE 25; 100 mg/g; mg/g N 20181231 70015-655_d417edfb-86ce-4554-b1ce-ce126af62abb 70015-655 HUMAN OTC DRUG OxyRub Pro Pain Relief Cream, 4oz Menthol, Methyl Salicylate CREAM TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part348 Healthy Directions, LLC MENTHOL; METHYL SALICYLATE 25; 100 mg/g; mg/g N 20181231 70017-020_59ffc4af-c714-4852-9fae-849e69ae9ef1 70017-020 HUMAN OTC DRUG Cluederm LIFTING Glycerin PATCH TOPICAL 20180130 OTC MONOGRAPH FINAL part347 CLASSYS INC. GLYCERIN 2.1 g/101 N 20191231 70018-010_ec76fa73-3967-4ae1-8e95-0f5e00d0c8e4 70018-010 HUMAN OTC DRUG Hyaluronic Acid Micro HYALURONATE SODIUM PATCH TOPICAL 20150701 UNAPPROVED DRUG OTHER JUNMOK INTERNATIONAL,INC HYALURONATE SODIUM 1.14 g/41 E 20171231 70019-100_9adde184-b4c5-4dfd-b2e0-a30ee8caff08 70019-100 HUMAN OTC DRUG Zzip Cold Sore Treatment ALLANTOIN, DIMETHICONE, MENTHOL SOLUTION TOPICAL 20150730 OTC MONOGRAPH NOT FINAL part348 Zzip AG ALLANTOIN; DIMETHICONE; MENTHOL 5; 10; 1 mg/mL; mg/mL; mg/mL E 20171231 70020-1910_63228840-387a-b4eb-e053-2a91aa0ab3d4 70020-1910 HUMAN PRESCRIPTION DRUG IXEMPRA ixabepilone KIT 20071016 NDA NDA022065 R-Pharm US Operating, LLC N 20191231 70020-1911_63228840-387a-b4eb-e053-2a91aa0ab3d4 70020-1911 HUMAN PRESCRIPTION DRUG IXEMPRA ixabepilone KIT INTRAVENOUS 20071016 NDA NDA022065 R-Pharm US Operating, LLC N 20191231 70026-001_5c4bd01a-d923-4fa4-a88c-593a2ef50ea7 70026-001 HUMAN OTC DRUG Yonis Bliss Chamomilla, Natrum Muriaticum GEL TOPICAL 20151023 UNAPPROVED HOMEOPATHIC Brookhaus Essentials LLC MATRICARIA RECUTITA; SODIUM CHLORIDE 6; 6 [hp_C]/g; [hp_C]/g N 20181231 70028-002_4228b14d-910c-7073-e054-00144ff88e88 70028-002 HUMAN OTC DRUG Proandre Benzalkonium Chloride LIQUID TOPICAL 20150820 OTC MONOGRAPH NOT FINAL part333E PROANDRE, SL BENZALKONIUM CHLORIDE .1 mg/mL E 20171231 70028-003_526213f2-af27-1393-e054-00144ff88e88 70028-003 HUMAN OTC DRUG Proandre Alcohol Denat AEROSOL, FOAM TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part333A Proandre SL ALCOHOL 40 mg/mL N 20181231 70031-001_62180579-6f7e-6a2c-e053-2a91aa0aa2ec 70031-001 HUMAN OTC DRUG Antibacterial Wipes benzethonium chloride SWAB TOPICAL 20150805 OTC MONOGRAPH NOT FINAL part333A TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY BENZETHONIUM CHLORIDE .3 g/100g N 20191231 70031-002_827a39c0-4324-4725-8787-b29cee24a575 70031-002 HUMAN OTC DRUG Assured BENZALKONIUM CHLORIDE LOTION TOPICAL 20160831 OTC MONOGRAPH NOT FINAL part333A TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY BENZALKONIUM CHLORIDE .1 g/100g E 20171231 70031-003_62180579-6f75-6a2c-e053-2a91aa0aa2ec 70031-003 HUMAN OTC DRUG Antibacterial Wet Wipes benzethonium chloride SWAB TOPICAL 20160310 OTC MONOGRAPH NOT FINAL part333A TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY BENZETHONIUM CHLORIDE .115 g/100g N 20191231 70034-001_16714dac-df60-4a15-b59a-733febac091a 70034-001 HUMAN OTC DRUG Tabakfre Equal amounts of each HPUS ingredient in 30C, 200C, 1M, LM1, LM2, LM3, LM4, and LM5 potencies SOLUTION ORAL 20150910 UNAPPROVED HOMEOPATHIC Primal Earth LLC ACONITUM NAPELLUS; .ALPHA.-LIPOIC ACID, (+/-)-; AGRIMONIA EUPATORIA FLOWER; AMMONIA; AMMONIUM CARBONATE; ANTIMONY ARSENATE; ANTIMONY POTASSIUM TARTRATE; ANTIMONY TRISULFIDE; ARABICA COFFEE BEAN; ARSENIC TRIIODIDE; ARSENIC TRIOXIDE; ASARUM EUROPAEUM; ASPIDOSPERMA QUEBRACHO-BLANCO BARK; ATROPA BELLADONNA; AVENA SATIVA FLOWERING TOP; BOS TAURUS HYPOTHALAMUS; BROMINE; CALCIUM IODIDE; CAPSICUM; CARBON DISULFIDE; CARBON MONOXIDE; CHELIDONIUM MAJUS; CHLORINE; CHLOROFORM; CINCHONA OFFICINALIS BARK; COENZYME A; CONIUM MACULATUM FLOWERING TOP; CORTICOTROPIN; DAPHNE ODORA BARK; DATURA STRAMONIUM; DELPHINIUM STAPHISAGRIA SEED; DIEFFENBACHIA SEGUINE; ECHINACEA PURPUREA; EPINEPHRINE; ESCHSCHOLZIA CALIFORNICA; FORMALDEHYDE; GLYCYRRHIZA GLABRA; GOLDENSEAL; HELIANTHUS ANNUUS FLOWERING TOP; HERRING SPERM DNA; HOPS; HORSE CHESTNUT; HYPERICUM PERFORATUM; JUGLANS REGIA FLOWERING TOP; JUNIPERUS COMMUNIS WHOLE; LEAD; LIQUID PETROLEUM; LOBARIA PULMONARIA; LOBELIA INFLATA; LONICERA PERICLYMENUM FLOWERING TWIG; LYCOPODIUM CLAVATUM SPORE; MATRICARIA RECUTITA; MERCURY; NICOTINE; OXOGLURIC ACID; PASSIFLORA INCARNATA FLOWERING TOP; PHENOL; PHYTOLACCA AMERICANA ROOT; PICEA MARIANA RESIN; PLANTAGO MAJOR; POTASSIUM CARBONATE; POTASSIUM CHLORIDE; POTASSIUM DICHROMATE; POTASSIUM IODIDE; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA PRATENSIS; RICINUS COMMUNIS SEED; SCROPHULARIA NODOSA; SEMECARPUS ANACARDIUM JUICE; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; SUCROSE; SULFUR IODIDE; SULFURIC ACID; SUS SCROFA PITUITARY GLAND; SYZYGIUM JAMBOS SEED; TARAXACUM OFFICINALE; THUJA OCCIDENTALIS LEAFY TWIG; TIN; TOBACCO LEAF; TRIBASIC CALCIUM PHOSPHATE 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; [hp_C]/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; [hp_C]/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL; 1/60mL E 20171231 70038-010_dcb551ea-d69d-4d18-aa36-4aee1172711c 70038-010 HUMAN OTC DRUG REVITAL PERFECTING DUAL AMPOULE Niacinamide SOLUTION TOPICAL 20150710 UNAPPROVED DRUG OTHER RAONBIO CORP NIACINAMIDE .4 mg/20mL E 20171231 70039-200_42f2ac23-0c15-249c-e054-00144ff8d46c 70039-200 HUMAN OTC DRUG Professional Therapy MuscleCare Extra Strength Menthol, Camphor GEL CUTANEOUS; TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part348 Active and Innovative Inc. MENTHOL; CAMPHOR (SYNTHETIC) 100; 40 mg/g; mg/g N 20181231 70039-201_42f1e14a-3ac7-01c1-e054-00144ff8d46c 70039-201 HUMAN OTC DRUG Professional Therapy MuscleCare Turbo Menthol, Camphor GEL CUTANEOUS; TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part348 Active and Innovative Inc. MENTHOL; CAMPHOR (SYNTHETIC) 140; 100 mg/g; mg/g N 20181231 70039-283_39bd979f-91a1-0554-e054-00144ff8d46c 70039-283 HUMAN OTC DRUG Professional Therapy MuscleCare pain relieving gel Extra Strength Camphor, Menthol GEL CUTANEOUS; TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part348 Active and Innovative Inc. CAMPHOR (SYNTHETIC); MENTHOL 40; 100 mg/g; mg/g N 20181231 70039-298_39cf0152-0f2a-1077-e054-00144ff8d46c 70039-298 HUMAN OTC DRUG Professional Therapy MuscleCare Camphor, Menthol CREAM CUTANEOUS; TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part348 Active and Innovative Inc. CAMPHOR (SYNTHETIC); MENTHOL 40; 40 mg/g; mg/g N 20181231 70039-300_42f1abeb-f6d8-01c3-e054-00144ff88e88 70039-300 HUMAN OTC DRUG Professional Therapy MuscleCare Pain Relieving Menthol, Camphor OINTMENT CUTANEOUS; TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part348 Active and Innovative Inc. MENTHOL; CAMPHOR (SYNTHETIC) 40; 40 mg/g; mg/g N 20181231 70041-1001_78e9ee1b-f216-4856-b83a-d535fac1d176 70041-1001 HUMAN OTC DRUG Swallow Nest White Ginseng DIMETHICONE CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part347 NATURES Co., Ltd. DIMETHICONE .5 g/100g E 20171231 70042-0001_643580b9-a697-5afc-e053-2991aa0a367e 70042-0001 HUMAN OTC DRUG ZENOL POWERFULX RECOVERYCREAM Stearic Acid CREAM TOPICAL 20180202 UNAPPROVED DRUG OTHER Flexpoweraws STEARIC ACID 1.5 g/100mL N 20191231 70042-1001_f824041f-9845-45e9-a6f9-7cad732568a2 70042-1001 HUMAN OTC DRUG Flexpower Recovery Glycerin CREAM TOPICAL 20150811 OTC MONOGRAPH FINAL part347 Flexpoweraws GLYCERIN 2 g/100mL N 20181231 70042-2001_b358132d-51b1-458a-861c-b2429b9599c7 70042-2001 HUMAN OTC DRUG Flexpower Sun Block DIMETHICONE GEL TOPICAL 20150811 OTC MONOGRAPH FINAL part347 Flexpoweraws DIMETHICONE 2 g/100mL N 20181231 70042-3001_bb6ff7fc-307f-4e7e-a349-38e2ef565c28 70042-3001 HUMAN OTC DRUG Flexpower Recovery DIMETHICONE CREAM TOPICAL 20151109 OTC MONOGRAPH FINAL part347 Flexpoweraws DIMETHICONE 1 g/100mL N 20181231 70042-4001_28e20b0e-51fd-417c-a06f-8079afa6b712 70042-4001 HUMAN OTC DRUG Flexpower Recovery Youth DIMETHICONE CREAM TOPICAL 20151109 OTC MONOGRAPH FINAL part347 Flexpoweraws DIMETHICONE 1 g/100mL N 20181231 70042-5001_44c258e6-9c84-56f2-e054-00144ff8d46c 70042-5001 HUMAN OTC DRUG Flex-Power Recovery DIMETHICONE CREAM TOPICAL 20161229 OTC MONOGRAPH FINAL part347 Flexpoweraws DIMETHICONE 1 g/100mL N 20181231 70042-6001_6265f723-b616-c255-e053-2991aa0a5232 70042-6001 HUMAN OTC DRUG Doctor Plus Stearic Acid CREAM TOPICAL 20180109 UNAPPROVED DRUG OTHER Flexpoweraws STEARIC ACID 1.5 g/100mL N 20191231 70043-390_817e487e-fe10-46a2-ac08-b324856690f1 70043-390 HUMAN OTC DRUG Sterile Antibacterial Wound Wash Benzalkonium Chloride SPRAY TOPICAL 20160623 OTC MONOGRAPH NOT FINAL part333A Ascot Pharmaceuticals, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 70046-0001_1bcb5bc5-4890-45b5-b149-a58644365469 70046-0001 HUMAN OTC DRUG BIO SKIN Crystal Bio-Cellulose Mask GLYCERIN LIQUID TOPICAL 20150923 OTC MONOGRAPH FINAL part347 Bonitacoco GLYCERIN 5 g/100mL E 20171231 70047-0001_f50aab33-2afe-411f-a6b3-4882679e203f 70047-0001 HUMAN OTC DRUG BL Vital ALLANTOIN CREAM TOPICAL 20150831 OTC MONOGRAPH FINAL part347 RECELL U KOREA ALLANTOIN .1 g/100mL E 20171231 70047-0002_52c57859-6ff6-401b-a3de-7715f6d02b6e 70047-0002 HUMAN OTC DRUG BL Vital ALLANTOIN EMULSION TOPICAL 20150831 OTC MONOGRAPH FINAL part347 RECELL U KOREA ALLANTOIN .1 g/100mL E 20171231 70047-0003_a85f6f87-e569-4650-8844-346baa2d43a2 70047-0003 HUMAN OTC DRUG BL Vital Essence ALLANTOIN LIQUID TOPICAL 20150831 OTC MONOGRAPH FINAL part347 RECELL U KOREA ALLANTOIN .1 g/100mL E 20171231 70047-0004_efd3655f-34ff-4b62-b04c-7edb291423c4 70047-0004 HUMAN OTC DRUG BL Vital Serum ALLANTOIN LIQUID TOPICAL 20150831 OTC MONOGRAPH FINAL part347 RECELL U KOREA ALLANTOIN .1 g/100mL E 20171231 70047-0005_4b0c94fc-99ea-414f-8d1a-ca56b8816b84 70047-0005 HUMAN OTC DRUG BL Vital Skin ALLANTOIN LIQUID TOPICAL 20150831 OTC MONOGRAPH FINAL part347 RECELL U KOREA ALLANTOIN .1 g/100mL E 20171231 70047-0006_668774ec-b218-47d6-9de0-ac37aaba2468 70047-0006 HUMAN OTC DRUG CP Bebe GLYCERIN LOTION TOPICAL 20150831 OTC MONOGRAPH FINAL part347 RECELL U KOREA GLYCERIN 3 g/100mL E 20171231 70047-0007_b21d7e16-992c-4cd4-9146-23d7bd621705 70047-0007 HUMAN OTC DRUG CP Bebe wash GLYCERIN SHAMPOO TOPICAL 20150831 OTC MONOGRAPH FINAL part347 RECELL U KOREA GLYCERIN .001 g/100mL E 20171231 70047-0008_d76e097f-6cdb-4901-aeee-119c39561d22 70047-0008 HUMAN OTC DRUG CP Medi GLYCERIN CREAM TOPICAL 20150831 OTC MONOGRAPH FINAL part347 RECELL U KOREA GLYCERIN 6 g/100mL E 20171231 70047-0009_5423e45c-1ae0-4520-8b00-c5fd94f7494e 70047-0009 HUMAN OTC DRUG CP Medi GLYCERIN EMULSION TOPICAL 20150831 OTC MONOGRAPH FINAL part347 RECELL U KOREA GLYCERIN 10 g/100mL E 20171231 70047-0010_5cc2ddba-5e4c-413b-971e-6e332d1b0961 70047-0010 HUMAN OTC DRUG CP Medi theraphy GLYCERIN GEL TOPICAL 20150831 OTC MONOGRAPH FINAL part347 RECELL U KOREA GLYCERIN .2 g/100mL E 20171231 70047-0011_62573dba-a5bb-4b06-a606-19a3b240ca60 70047-0011 HUMAN OTC DRUG Premium natural BL hydrogel mask pack GLYCERIN GEL TOPICAL 20150831 OTC MONOGRAPH FINAL part347 RECELL U KOREA GLYCERIN 9 g/100mL E 20171231 70048-001_82c53d42-4efc-4588-b634-07fd661bb755 70048-001 HUMAN OTC DRUG Anti-Aging Day Protect SPF 22 Octinoxate, Octisalate, and Avobenzone LOTION TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Swiss Botany OCTINOXATE; OCTISALATE; AVOBENZONE 75; 50; 20 mg/g; mg/g; mg/g E 20171231 70052-001_2a533709-0af0-1f29-e054-00144ff8d46c 70052-001 HUMAN OTC DRUG Subsidium Naja Naja STRIP ORAL 20151001 UNAPPROVED HOMEOPATHIC Subsidium, LLC NAJA NAJA VENOM 10 [hp_X]/1 E 20171231 70053-010_7dc87b3f-74dc-41b4-8591-c610ae345349 70053-010 HUMAN OTC DRUG Chevance Pyrithione Zinc SHAMPOO TOPICAL 20150701 OTC MONOGRAPH FINAL part358H Yes Miracle Ltd PYRITHIONE ZINC 5.8 mg/290mL N 20181231 70058-001_e64c669a-ac38-491b-9f86-b7f8500cabb3 70058-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20150824 UNAPPROVED MEDICAL GAS Central Medical Supply OXYGEN 99 L/100L E 20171231 70060-1501_1d9b26a7-7178-1039-e054-00144ff8d46c 70060-1501 HUMAN OTC DRUG Replenishing Sunscreen SPF 36 Sunscreen CREAM TOPICAL 20150818 OTC MONOGRAPH NOT FINAL part352 CosMedical Technologies, LLC OCTINOXATE; OXYBENZONE; ZINC OXIDE; OCTISALATE 7.5; 6; 5; 5 g/50mL; g/50mL; g/50mL; g/50mL E 20171231 70060-1502_1daa1441-c71f-064f-e054-00144ff8d46c 70060-1502 HUMAN OTC DRUG Daily Replenishing SPF 30 Sunscreen CREAM TOPICAL 20150818 OTC MONOGRAPH NOT FINAL part352 CosMedical Technologies, LLC ZINC OXIDE; TITANIUM DIOXIDE 7.5; 4 g/60mL; g/60mL E 20171231 70060-1503_2d9e06f7-f9f5-6fc2-e054-00144ff88e88 70060-1503 HUMAN OTC DRUG Salicylic Face and Body Wash Salicylic Acid Soap LIQUID TOPICAL 20151104 OTC MONOGRAPH FINAL part333D CosMedical Technologies SALICYLIC ACID .02 mg/mL N 20181231 70060-1504_23b87395-44b9-391a-e054-00144ff8d46c 70060-1504 HUMAN OTC DRUG 5% BP Face and Body Wash Acne Treatment LIQUID TOPICAL 20151104 OTC MONOGRAPH FINAL part333D CosMedical Technologies BENZOYL PEROXIDE 50 mg/mL N 20181231 70060-1505_23bd8842-5239-4131-e054-00144ff8d46c 70060-1505 HUMAN OTC DRUG Acne Spot Treatment Salicylic Acid Acne Treatment LIQUID TOPICAL 20151104 OTC MONOGRAPH FINAL part333D CosMedical Technologies SALICYLIC ACID .02 mg/mL N 20181231 70060-1506_23bde802-d84b-1ecc-e054-00144ff88e88 70060-1506 HUMAN OTC DRUG Overnight Spot Treatment Acne Treatment LIQUID TOPICAL 20151104 OTC MONOGRAPH FINAL part333D CosMedical Technologies SULFUR 10 g/mL N 20181231 70064-001_26903b19-39dd-4ff2-8537-be8e7aad0c06 70064-001 HUMAN OTC DRUG nosudamas Carrying Kit Aluminum Zirconium Tetrachlorohydrex GLY CREAM TOPICAL 20150904 OTC MONOGRAPH FINAL part350 Geylanni International cosmetic developments LTD ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 80 mg/mL E 20171231 70064-002_1dad45fd-2ef0-45a7-aa70-63e1440320d1 70064-002 HUMAN OTC DRUG nosudamas for MEN Aluminum Zirconium Tetrachlorohydrex GLY CREAM TOPICAL 20150903 OTC MONOGRAPH FINAL part350 Geylanni International cosmetic developments LTD ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 80 mg/mL E 20171231 70064-003_7f216d11-5349-4bb1-8918-ac9e8950774c 70064-003 HUMAN OTC DRUG nosudamas for Normal to Dry Skin Aluminum Zirconium Tetrachlorohydrex GLY CREAM TOPICAL 20150904 OTC MONOGRAPH FINAL part350 Geylanni International cosmetic developments LTD ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 80 mg/mL E 20171231 70064-004_75018f87-aaa8-435c-8810-6fb4aba3eb72 70064-004 HUMAN OTC DRUG nosudamas for for Normal to Fat Skin Aluminum Zirconium Tetrachlorohydrex GLY CREAM TOPICAL 20150830 OTC MONOGRAPH FINAL part350 Geylanni International cosmetic developments LTD ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY 80 mg/mL E 20171231 70065-213_8647161a-c776-45f2-968e-7bef1ab0e1cf 70065-213 HUMAN OTC DRUG BAMA Freeze MENTHOL LINIMENT TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part348 Jonathan International, Inc. MENTHOL 3.7 g/100mL E 20171231 70066-1001_bdfbdb88-ee04-4804-a80c-2096ed1c88b8 70066-1001 HUMAN OTC DRUG Remember Hydrosol Double Effect GLYCERIN CREAM TOPICAL 20150903 OTC MONOGRAPH FINAL part347 DR.Haskin Co.,Ltd GLYCERIN 5 g/100mL E 20171231 70066-2001_6acd4813-4bbc-41c9-98b5-3a098e003b43 70066-2001 HUMAN OTC DRUG Miracle Ato Moisture Body Wash GLYCERIN LIQUID TOPICAL 20150903 OTC MONOGRAPH FINAL part347 DR.Haskin Co.,Ltd GLYCERIN 5 g/100mL E 20171231 70067-1001_44fc2509-7fb8-43fb-9ee9-be281048e833 70067-1001 HUMAN OTC DRUG PRO RADIANCE RENASCENT AN INFINITE ENERGIZER GLYCERIN EMULSION TOPICAL 20150903 OTC MONOGRAPH FINAL part347 Shine&Shine Co.,Ltd GLYCERIN 6 g/100mL E 20171231 70067-2001_8f458ba6-6c44-49f3-9adb-4af86b54dd99 70067-2001 HUMAN OTC DRUG PRO RADIANCE RENASCENT AN INFINITE ENERGIZER MOISTURIZER GLYCERIN LIQUID TOPICAL 20150903 OTC MONOGRAPH FINAL part347 Shine&Shine Co.,Ltd GLYCERIN 4 g/100mL E 20171231 70067-3001_33e1ea8b-ded2-47eb-91a0-d948d5756cb3 70067-3001 HUMAN OTC DRUG PRO RADIANCE RENASCENT AN INFINITE ENERGIZER GLYCERIN CREAM TOPICAL 20150903 OTC MONOGRAPH FINAL part347 Shine&Shine Co.,Ltd GLYCERIN 7 g/100mL E 20171231 70068-001_5b720973-1df0-2409-e053-2a91aa0a01f8 70068-001 HUMAN OTC DRUG DAY Daily Anti-Aging Moisturizing Face Broad Spectrum SPF 20 Sunscreen ZINC OXIDE, OCTINOXATE CREAM TOPICAL 20150826 OTC MONOGRAPH NOT FINAL part352 IDLife, LLC ZINC OXIDE; OCTINOXATE 50; 75 mg/mL; mg/mL N 20181231 70069-005_efb22b79-b14b-46a4-9eba-fd629154694d 70069-005 HUMAN PRESCRIPTION DRUG cyanocobalamin cyanocobalamin INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20160616 ANDA ANDA206503 Somerset Therapeutics, LLC CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 70069-007_f70f4372-fa89-4514-9763-8a2b7027756a 70069-007 HUMAN PRESCRIPTION DRUG OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 20160629 ANDA ANDA206306 Somerset Therapeutics, LLC OLOPATADINE HYDROCHLORIDE 1.11 mg/mL Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 70069-008_42e3df84-3ae4-4391-b747-bff68554a568 70069-008 HUMAN PRESCRIPTION DRUG EPINASTINE HYDROCHLORIDE EPINASTINE HYDROCHLORIDE SOLUTION/ DROPS OPHTHALMIC 20160914 ANDA ANDA090951 Somerset Therapeutics, LLC EPINASTINE HYDROCHLORIDE .5 mg/mL Adrenergic Agonists [MoA],Adrenergic Receptor Agonist [EPC],Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC] N 20181231 70069-011_cc8c6cb3-a99c-497a-85d6-70a06a70293d 70069-011 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20170626 ANDA ANDA207639 Somerset Therapeutics, LLC GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70069-012_cc8c6cb3-a99c-497a-85d6-70a06a70293d 70069-012 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20170626 ANDA ANDA207639 Somerset Therapeutics, LLC GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70069-013_cc8c6cb3-a99c-497a-85d6-70a06a70293d 70069-013 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20170626 ANDA ANDA207639 Somerset Therapeutics, LLC GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70069-014_cc8c6cb3-a99c-497a-85d6-70a06a70293d 70069-014 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20170626 ANDA ANDA207639 Somerset Therapeutics, LLC GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70069-071_d8b851af-3f2a-495e-85d6-61167e3b288b 70069-071 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20170810 ANDA ANDA207633 Somerset Therapeutics, LLC NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 70069-072_5579c4dd-08fd-49a6-96f4-84ab047ad5a1 70069-072 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20170803 ANDA ANDA207634 Somerset Therapeutics, LLC NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 70069-101_28a7029b-a34a-42de-9157-20ad6b53bb78 70069-101 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol INJECTION INTRAMUSCULAR; INTRAVENOUS 20170810 ANDA ANDA207522 Somerset Therapeutics, LLC METHOCARBAMOL 100 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70069-131_3e04e8b2-4691-48d4-869b-f1c8b6dbbc55 70069-131 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC 20170705 ANDA ANDA207444 Somerset Therapeutics, LLC TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 70069-172_efb22b79-b14b-46a4-9eba-fd629154694d 70069-172 HUMAN PRESCRIPTION DRUG cyanocobalamin cyanocobalamin INJECTION INTRAMUSCULAR; SUBCUTANEOUS 20170704 ANDA ANDA206503 Somerset Therapeutics, LLC CYANOCOBALAMIN 1000 ug/mL Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 70072-001_47eb787c-cffe-4f00-979c-2e8789974824 70072-001 HUMAN OTC DRUG Cocobath Waterless BENZALKONIUM CHLORIDE SHAMPOO TOPICAL 20150905 UNAPPROVED DRUG OTHER giod Co. BENZALKONIUM CHLORIDE .19 g/191.64g E 20171231 70072-002_41c6741e-22e1-4e66-9934-abc0715bf650 70072-002 HUMAN OTC DRUG ELF Color P-PHENYLENEDIAMINE CREAM TOPICAL 20150905 UNAPPROVED DRUG OTHER giod Co. P-PHENYLENEDIAMINE 9.58 g/479.39g E 20171231 70072-003_3dc369ae-605a-4e67-9757-09bcb97fc6c5 70072-003 HUMAN OTC DRUG ELF Perm PANTHENOL CREAM TOPICAL 20150905 UNAPPROVED DRUG OTHER giod Co. PANTHENOL .47 g/479.39g E 20171231 70073-001_e47533ff-d61b-46c0-a109-6fc02d9251c5 70073-001 HUMAN OTC DRUG lorpur CAMPHOR, MENTHOL OIL TOPICAL 20151025 OTC MONOGRAPH NOT FINAL part348 A. G. INDUSTRIES CAMPHOR (SYNTHETIC); MENTHOL 1; 2 g/100mL; g/100mL E 20171231 70074-802_456d9751-abe7-301c-e054-00144ff88e88 70074-802 HUMAN OTC DRUG Hello Kitty by Sanrio Hand Sanitizer ETHYL ALCOHOL SOLUTION TOPICAL 20150821 OTC MONOGRAPH NOT FINAL part333E 4e Brands Northamerica LLC ALCOHOL 65 mL/100mL N 20181231 70076-101_453893b0-bfe4-5b4b-e054-00144ff8d46c 70076-101 HUMAN OTC DRUG InstaNatural Acne Cleanser Salicylic Acid GEL TOPICAL 20160129 OTC MONOGRAPH FINAL part358H InstaNatural SALICYLIC ACID 2 mg/2mL N 20181231 70076-201_45389641-b703-5bc9-e054-00144ff8d46c 70076-201 HUMAN OTC DRUG InstaNatural Acne Moisturizer Salicylic Acid CREAM TOPICAL 20160105 OTC MONOGRAPH FINAL part358H InstaNatural SALICYLIC ACID .5 mg/.5mL N 20181231 70076-301_45389641-b6fa-5bc9-e054-00144ff8d46c 70076-301 HUMAN OTC DRUG InstaNatural Pain Relief Gel Menthol GEL TOPICAL 20160129 OTC MONOGRAPH FINAL part341 InstaNatural MENTHOL 5 mg/5mL N 20181231 70076-401_4e8f2029-3d5d-118e-e054-00144ff8d46c 70076-401 HUMAN OTC DRUG InstaNatural Vitamin C Moisturizer SPF30 Zinc Oxide, Titanium Dioxide, Octisalate CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part352 InstaNatural ZINC OXIDE; TITANIUM DIOXIDE; OCTISALATE 2.5; 1.5; 2.5 g/50g; g/50g; g/50g N 20181231 70076-501_4e901a2b-23cf-4118-e054-00144ff8d46c 70076-501 HUMAN OTC DRUG InstaNatural Eczema Cream Colloidal Oatmeal CREAM TOPICAL 20170615 OTC MONOGRAPH FINAL part347 InstaNatural OATMEAL 1.2 g/120g N 20181231 70079-101_8befe6fa-37c0-4b7b-97c7-83d338690a89 70079-101 HUMAN OTC DRUG Purehold Antiseptic Instant Hand Sanitizer Ethyl alcohol, Isopropyl alcohol GEL TOPICAL 20150803 OTC MONOGRAPH NOT FINAL part333A Pure Hold Ltd ALCOHOL; ISOPROPYL ALCOHOL 75; 4 mL/100mL; mL/100mL N 20181231 70080-001_626a2104-092a-4e89-8298-9a88ff08bdfd 70080-001 HUMAN OTC DRUG Thermalab Daily Body SPF30 Broad Spectrum Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20150815 OTC MONOGRAPH NOT FINAL part352 Market Group New York LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 4.5; 15; 7.5; 6; 6 g/150g; g/150g; g/150g; g/150g; g/150g N 20181231 70081-001_92e73269-f2db-4281-8506-485b991595f0 70081-001 HUMAN OTC DRUG SUN PROTECTIVE DAY CLEANSER SUNSCREEN AVOBENZONE, OCTINOXATE AND OCTOCRYLENE CREAM TOPICAL 20151026 OTC MONOGRAPH NOT FINAL part352 Dr Russo Skincare Ltd AVOBENZONE; OCTINOXATE; OCTOCRYLENE 2.75; 7.2; 7.04 g/100mL; g/100mL; g/100mL N 20181231 70081-002_39dd88a7-86de-4eaa-a58d-59ec1d489b3f 70081-002 HUMAN OTC DRUG SUN PROTECTIVE DAY MOISTURIZER SUNSCREEN AVOBENZONE, OCTINOXATE, OCTOCRYLENE AND OXYBENZONE CREAM TOPICAL 20151024 OTC MONOGRAPH NOT FINAL part352 Dr Russo Skincare Ltd AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 10; 6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 70082-002_f72331e4-3501-4314-ac65-c418a0bd65e9 70082-002 HUMAN OTC DRUG Alcohol Alcohol SWAB TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part333A Dealmed Medical Supplies LLC ISOPROPYL ALCOHOL .7 mL/mL N 20181231 70083-001_1fef81da-dab2-5684-e054-00144ff88e88 70083-001 HUMAN OTC DRUG TOUCHLAND kub2go Hand Sanitizer Mint ALCOHOL LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Distribuciones Touchland S.L. ISOPROPYL ALCOHOL .7 mL/mL E 20171231 70083-002_1ff16b85-b5ac-413d-e054-00144ff88e88 70083-002 HUMAN OTC DRUG TOUCHLAND kub2go Hand Sanitizer Aloe Vera ALCOHOL LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Distribuciones Touchland S.L. ISOPROPYL ALCOHOL .7 mL/mL E 20171231 70083-003_203ea15e-e8b9-0885-e054-00144ff8d46c 70083-003 HUMAN OTC DRUG TOUCHLAND kub2go Hand Sanitizer Strawberry ALCOHOL LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Distribuciones Touchland S.L. ISOPROPYL ALCOHOL .7 mL/mL E 20171231 70083-005_203f155c-f094-4116-e054-00144ff88e88 70083-005 HUMAN OTC DRUG TOUCHLAND kub2go Hand Sanitizer Citrus ALCOHOL LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Distribuciones Touchland S.L. ISOPROPYL ALCOHOL .7 mL/mL E 20171231 70083-006_203ea858-3479-2790-e054-00144ff8d46c 70083-006 HUMAN OTC DRUG TOUCHLAND kub2go Hand Sanitizer Lavender ALCOHOL LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Distribuciones Touchland S.L. ISOPROPYL ALCOHOL .7 mL/mL E 20171231 70083-007_1fedc0c2-498d-407e-e054-00144ff8d46c 70083-007 HUMAN OTC DRUG TOUCHLAND kub2go Hand Sanitizer Neutral ALCOHOL LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Distribuciones Touchland S.L. ISOPROPYL ALCOHOL .7 mL/mL E 20171231 70083-008_20400cc1-d9b5-5adb-e054-00144ff8d46c 70083-008 HUMAN OTC DRUG TOUCHLAND kub2go Hand Sanitizer Vanilla ALCOHOL LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Distribuciones Touchland S.L. ISOPROPYL ALCOHOL .7 mL/mL E 20171231 70083-101_20400cc1-d9c7-5adb-e054-00144ff8d46c 70083-101 HUMAN OTC DRUG TOUCHLAND Refeel KUB cartridge ALCOHOL LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Distribuciones Touchland S.L. ISOPROPYL ALCOHOL .7 mL/mL E 20171231 70084-210_cd85bbbd-89eb-47d0-b555-abb0ebaabfc2 70084-210 HUMAN OTC DRUG Lip Clear Lysine Plus Coldstick Octinoxate and Oxybenzone LIPSTICK TOPICAL 19970106 OTC MONOGRAPH FINAL part352 Quantum, Inc. OCTINOXATE; OXYBENZONE 70; 50 mg/g; mg/g N 20181231 70084-220_4058f52f-39e1-41cd-80d1-0d9213952fc0 70084-220 HUMAN OTC DRUG Super Lysine Plus Coldstick Octinoxate and Oxybenzone LIPSTICK TOPICAL 19970106 OTC MONOGRAPH FINAL part352 Quantum, Inc. OCTINOXATE; OXYBENZONE 70; 50 mg/g; mg/g N 20181231 70084-230_365093a3-47db-4c60-b976-45d421114d4b 70084-230 HUMAN OTC DRUG Super Lysine Plus Tangerine Lip Treatment Octinoxate and Oxybenzone LIPSTICK TOPICAL 20010402 OTC MONOGRAPH FINAL part352 Quantum, Inc. OCTINOXATE; OXYBENZONE 70; 50 mg/g; mg/g N 20181231 70084-240_5597234c-c19e-4911-a0ce-94c824c304a7 70084-240 HUMAN OTC DRUG Super Lysine Plus Strawberry Lip Treatment Octinoxate and Oxybenzone LIPSTICK TOPICAL 20010402 OTC MONOGRAPH FINAL part352 Quantum, Inc. OCTINOXATE; OXYBENZONE 70; 50 mg/g; mg/g N 20181231 70084-320_238c8d4b-3a58-4877-a200-6d6d24783487 70084-320 HUMAN OTC DRUG Lip Clear Lysine Plus Menthol, Unspecified Form OINTMENT TOPICAL 19841001 OTC MONOGRAPH FINAL part341 Quantum, Inc. MENTHOL, UNSPECIFIED FORM 1 mg/g N 20181231 70084-420_e9a1c66f-4f34-4b75-8eb3-1b374e164eee 70084-420 HUMAN OTC DRUG Super Lysine plus Menthol, Unspecified Form OINTMENT TOPICAL 19841001 OTC MONOGRAPH FINAL part341 Quantum, Inc. MENTHOL, UNSPECIFIED FORM 1 mg/g N 20181231 70084-500_97d1fdec-5290-41e8-8532-6d4079a91ee8 70084-500 HUMAN OTC DRUG Canker Care Plus Menthol, Unspecified Form LIQUID TOPICAL 20030401 OTC MONOGRAPH NOT FINAL part356 Quantum, Inc. MENTHOL, UNSPECIFIED FORM 5 mg/mL N 20181231 70084-510_36750ffe-cb86-4193-8538-8effc0efd1e6 70084-510 HUMAN OTC DRUG Athletes Foot Tolnaftate CREAM TOPICAL 20051205 OTC MONOGRAPH FINAL part333C Quantum, Inc. TOLNAFTATE 10 mg/g N 20181231 70084-605_aaf7343b-9f7c-413b-b1b8-169d985d13b6 70084-605 HUMAN OTC DRUG Quantum Health Meyer Lemon and Honey Flavor Menthol, Unspecified Form LOZENGE ORAL 20170501 OTC MONOGRAPH FINAL part341 Quantum, Inc. MENTHOL, UNSPECIFIED FORM 5 mg/1 N 20181231 70084-610_bad205c6-e7db-43f7-a8ed-0b0eeb1c6164 70084-610 HUMAN OTC DRUG Quantum Health Bing Cherry Flavor Menthol, Unspecified Form LOZENGE ORAL 20170501 OTC MONOGRAPH FINAL part341 Quantum, Inc. MENTHOL, UNSPECIFIED FORM 5 mg/1 N 20181231 70087-010_cbe6d2d9-0307-4dd4-8a0c-ab6bca9f7477 70087-010 HUMAN OTC DRUG TEN TEN CELL Glycerin SOLUTION TOPICAL 20150801 UNAPPROVED DRUG OTHER MARIA BIOTECH CO., LTD. GLYCERIN .12 mg/101 E 20171231 70089-100_1f82d7ca-4e2a-4550-bc7d-8803fd5c7745 70089-100 HUMAN OTC DRUG ScarScreen Zinc Oxide LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 Natural Crest Laboratories Inc. ZINC OXIDE .75 g/5mL E 20171231 70091-1001_a0a7c3d5-9382-4511-b15e-da65491cf01e 70091-1001 HUMAN OTC DRUG ALA-C Cell clinic solution GLYCERIN CREAM TOPICAL 20150903 OTC MONOGRAPH FINAL part347 DAOOMCOSTECH.co.Ltd. GLYCERIN 5 g/100mL E 20171231 70091-2001_5e84785e-9d43-4ba6-b47a-e3c9e30ecd91 70091-2001 HUMAN OTC DRUG ALA-C Snail Cell Reparing Essence NIACINAMIDE LIQUID TOPICAL 20150903 UNAPPROVED DRUG OTHER DAOOMCOSTECH.co.Ltd. NIACINAMIDE 2 g/100mL E 20171231 70096-001_603827b3-d1fa-ea82-e053-2a91aa0af47a 70096-001 HUMAN OTC DRUG Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part333E Hot Focus, Inc. BENZALKONIUM CHLORIDE .13 g/mL N 20181231 70097-001_f32f924d-458d-4d98-9a7c-485d6d62c66e 70097-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20040101 NDA NDA205712 Precision Oxygen & Supply OXYGEN 990 mL/L N 20181231 70097-002_7d4d6edf-db76-44c6-97d2-618d7fa43ab8 70097-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20040101 NDA NDA205766 Precision Oxygen & Supply NITROGEN 990 mL/L N 20181231 70098-0001_2e94bc0d-6530-4df6-9f66-e1909a90c06a 70098-0001 HUMAN OTC DRUG SISEUNDEUSI BLESS BODY ALLANTOIN LOTION TOPICAL 20150831 OTC MONOGRAPH FINAL part347 GK COSMETIC CO., LTD. ALLANTOIN .1 g/100g N 20181231 70098-0002_a3cf7962-2f7f-4978-a1e4-7c6accf86d0f 70098-0002 HUMAN OTC DRUG LUMINANT UMBRELLA MASK PACK ALLANTOIN LIQUID TOPICAL 20160101 OTC MONOGRAPH FINAL part347 GK COSMETIC CO., LTD. ALLANTOIN .1 g/100mL N 20181231 70098-0003_419d82b7-0c0d-6a03-e054-00144ff8d46c 70098-0003 HUMAN OTC DRUG ATO STOP SISEUNDEUSI Aloe Barbadensis Leaf Water LOTION TOPICAL 20161118 UNAPPROVED DRUG OTHER GK COSMETIC CO., LTD. ALOE VERA LEAF 63.52 g/100g N 20181231 70098-0004_419eb66b-49ad-24bc-e054-00144ff8d46c 70098-0004 HUMAN OTC DRUG ATO STOP SISEUNDEUSI Aloe Barbadensis Leaf Water CREAM TOPICAL 20161118 UNAPPROVED DRUG OTHER GK COSMETIC CO., LTD. ALOE VERA LEAF 46.27 g/100g N 20181231 70098-0005_47e6b593-845e-4f78-e054-00144ff8d46c 70098-0005 HUMAN OTC DRUG SISEUNDEUSI LUMINANT SKIN TONER Niacinamide, Adenosine LIQUID TOPICAL 20170206 UNAPPROVED DRUG OTHER GK COSMETIC CO., LTD. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 70098-0006_47e773c8-8700-14ab-e054-00144ff8d46c 70098-0006 HUMAN OTC DRUG SISEUNDEUSI LUMINANT Niacinamide, Adenosine EMULSION TOPICAL 20170206 UNAPPROVED DRUG OTHER GK COSMETIC CO., LTD. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 70098-0007_4a427a02-d39b-5813-e054-00144ff8d46c 70098-0007 HUMAN OTC DRUG SISEUNDEUSI BLESS BATHANDSHAMPOO Glycerin GEL TOPICAL 20170309 OTC MONOGRAPH NOT FINAL part347 GK COSMETIC CO., LTD. GLYCERIN 2.661 g/100mL N 20181231 70098-0008_4a43560a-3619-076a-e054-00144ff8d46c 70098-0008 HUMAN OTC DRUG SISEUNDEUSI LUMINANT PACK CLEANSER Glycerin GEL TOPICAL 20170309 OTC MONOGRAPH NOT FINAL part347 GK COSMETIC CO., LTD. GLYCERIN .02 g/100mL N 20181231 70098-0009_4a43560a-3622-076a-e054-00144ff8d46c 70098-0009 HUMAN OTC DRUG SISEUNDEUSI LUMINANT Niacinamide CREAM TOPICAL 20170309 UNAPPROVED DRUG OTHER GK COSMETIC CO., LTD. NIACINAMIDE 2 g/100g N 20181231 70098-0010_4a43a0aa-8844-1608-e054-00144ff8d46c 70098-0010 HUMAN OTC DRUG SISEUNDEUSI LUMINANT MASK PACK STEP2(WHITENING) Niacinamide CREAM TOPICAL 20170309 UNAPPROVED DRUG OTHER GK COSMETIC CO., LTD. NIACINAMIDE 2 g/100mL N 20181231 70098-0011_51bdd15d-48a4-310d-e054-00144ff8d46c 70098-0011 HUMAN OTC DRUG SISEUNDEUSI LUMINANT ESSENCE Niacinamide, Adenosine LIQUID TOPICAL 20170501 UNAPPROVED DRUG OTHER GK COSMETIC CO., LTD. NIACINAMIDE; ADENOSINE 2.1; .045 g/100mL; g/100mL N 20181231 70098-0012_577ab34f-edfe-0d90-e053-2991aa0a07b0 70098-0012 HUMAN OTC DRUG SISEUNDEUSI ULTRA SPOT glycerin CREAM TOPICAL 20170824 OTC MONOGRAPH NOT FINAL part347 GK COSMETIC CO., LTD. GLYCERIN 5.05 g/100g N 20181231 70098-0013_5a1336de-1944-27c5-e053-2991aa0a1ca8 70098-0013 HUMAN OTC DRUG SISEUNDEUSI SCALP ESSENCE glycerin LIQUID TOPICAL 20170926 OTC MONOGRAPH NOT FINAL part347 GK COSMETIC CO., LTD. GLYCERIN .1 g/100mL N 20181231 70099-0002_0c52864c-f1cd-4549-a3bd-304ff722f288 70099-0002 HUMAN OTC DRUG Richway Amethyst Hydrogel Face Mask GLYCERIN LIQUID TOPICAL 20150831 OTC MONOGRAPH FINAL part347 R&L Co., Ltd. GLYCERIN 15 g/100g N 20181231 70099-0003_edcc0d55-e072-42d7-b2ef-a79a0bf5290a 70099-0003 HUMAN OTC DRUG Pure C Serum ALLANTOIN LIQUID TOPICAL 20151215 OTC MONOGRAPH FINAL part347 R&L Co., Ltd. ALLANTOIN 2 g/100mL N 20181231 70099-0004_44c258e6-9c6b-56f2-e054-00144ff8d46c 70099-0004 HUMAN OTC DRUG Pure C Serum Niacinamide, Adenosine LIQUID TOPICAL 20161229 UNAPPROVED DRUG OTHER R&L Co., Ltd. ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 70100-424_aca6fdea-5bda-4de8-a396-67e0504dce04 70100-424 HUMAN PRESCRIPTION DRUG Indocyanine Green Indocyanine Green and Water KIT 20080101 ANDA ANDA040811 Diagnostic Green GmbH N 20181231 70101-001_83e78466-27e5-41a0-8304-162aad98730a 70101-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20130401 NDA NDA205712 Gas and Supply OXYGEN 995 mL/L N 20181231 70101-002_6ac09705-a4e7-406a-a0c4-195cdba43fe9 70101-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20130401 NDA NDA205713 Gas and Supply NITROGEN 995 mL/L N 20181231 70104-110_253e0d06-8a37-5175-e054-00144ff8d46c 70104-110 HUMAN PRESCRIPTION DRUG B-Combo B-Combo INJECTION INTRAMUSCULAR 20151123 UNAPPROVED DRUG OTHER Perdido Key Health and Wellness Inc METHYLCOBALAMIN; RIBOFLAVIN; NIACINAMIDE; DEXPANTHENOL; PYRIDOXINE; THIAMINE 1; 1; 1; 1; 1; 1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70104-128_253ea822-c2e4-688b-e054-00144ff8d46c 70104-128 HUMAN PRESCRIPTION DRUG Lipovite Lipovite INJECTION INTRAMUSCULAR 20151123 UNAPPROVED DRUG OTHER Perdido Key Health and Wellness Inc LIDOCAINE; CITRULLINE; L-METHIONINE-S,R-SULFOXIMINE; CHOLINE; INOSITOL; THIAMINE; PYRIDOXINE; RIBOFLAVIN; NIACINAMIDE; METHYLCOBALAMIN; DEXPANTHENOL; CHROMIUM; LEVOCARNITINE 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Carnitine [Chemical/Ingredient],Carnitine Analog [EPC] E 20171231 70104-806_253ca66e-3c26-0483-e054-00144ff8d46c 70104-806 HUMAN PRESCRIPTION DRUG MIC B12 MIC B12 INJECTION INTRAMUSCULAR 20151123 UNAPPROVED DRUG OTHER Perdido Key Health and Wellness Inc INOSITOL; CHOLINE C-11; METHYLCOBALAMIN; L-METHIONINE-S,R-SULFOXIMINE 1; 1; 1; 1 mg/mL; mg/mL; mg/mL; mg/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 70104-825_24fe3c10-caeb-2c2b-e054-00144ff88e88 70104-825 HUMAN PRESCRIPTION DRUG Cyanocobalamin Cyanocobalamin INJECTION INTRAMUSCULAR 20151120 UNAPPROVED DRUG OTHER Perdido Key Health and Wellness Inc 8-EPI-CYANOCOBALAMIN 1 mg/mL E 20171231 70104-826_24fd5ca6-b69f-3542-e054-00144ff88e88 70104-826 HUMAN PRESCRIPTION DRUG Methylcobalamin Methylcobalamin INJECTION INTRAMUSCULAR 20151120 UNAPPROVED DRUG OTHER Perdido Key Health and Wellness Inc METHYLCOBALAMIN 1 mg/mL E 20171231 70105-001_5cb92286-7a65-4574-a6bc-d2831595fe0c 70105-001 HUMAN OTC DRUG Natural Relief Patch for MOTION SICKNESS Calendula Officinalis, Chamomilla, Sepia, Tabacum, Cocculus Indicus, Nux Vomica PATCH TOPICAL 20151214 UNAPPROVED HOMEOPATHIC Centered Enterprises, LLC CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; SEPIA OFFICINALIS JUICE; TOBACCO LEAF; ANAMIRTA COCCULUS SEED; STRYCHNOS NUX-VOMICA SEED 3; 3; 3; 6; 15; 15 [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 70105-002_5e7f90c9-4a8d-46cb-b64d-50ea654cb888 70105-002 HUMAN OTC DRUG Natural Relief Patch for MENSTRUAL CRAMPS Belladonna, Calendula Officinalis, Chamomilla, Colocynthis, Magnesia Phosphorica, Nux Vomica, Pulsatilla. PATCH TOPICAL 20151214 UNAPPROVED HOMEOPATHIC Centered Enterprises, LLC ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CITRULLUS COLOCYNTHIS FRUIT PULP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS 15; 3; 3; 15; 15; 6; 6 [hp_C]/1; [hp_X]/1; [hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 70107-302_c38030a1-faaf-432d-ae2a-ab6a26e53978 70107-302 HUMAN OTC DRUG STAMA PRO LIDOCAINE SPRAY TOPICAL 20170111 OTC MONOGRAPH FINAL part348 Cerno Pharmaceuticals LIDOCAINE 96 mg/mL N 20181231 70108-001_5c8a84b8-4b5d-752c-e053-2a91aa0a53ce 70108-001 HUMAN OTC DRUG Shopkins hand sanitizer Ethyl Alcohol GEL TOPICAL 20151020 OTC MONOGRAPH NOT FINAL part333E Ashtel Studios Inc. ALCOHOL 62 g/100g N 20181231 70108-002_330c6578-56fd-0479-e054-00144ff88e88 70108-002 HUMAN OTC DRUG Shopkins 3D Hand Sanitizer DLish Donut ethyl alcohol GEL TOPICAL 20160517 OTC MONOGRAPH NOT FINAL part333E Ashtel Studios, Inc. dba Brush Buddies ALCOHOL 62 g/100g N 20181231 70108-003_330f2d9c-28d0-597e-e054-00144ff88e88 70108-003 HUMAN OTC DRUG Shopkins 3D Hand Sanitizer Lippy Lips ethyl alcohol GEL TOPICAL 20160517 OTC MONOGRAPH NOT FINAL part333E Ashtel Studios, Inc. dba Brush Buddies ALCOHOL 62 g/100g N 20181231 70108-004_34cae02c-836f-46cd-e054-00144ff8d46c 70108-004 HUMAN OTC DRUG Kung Fu Panda Hand Sanitizer Chloroxylenol GEL TOPICAL 20160608 OTC MONOGRAPH NOT FINAL part333E Ashtel Studios Inc. CHLOROXYLENOL .05 g/59g N 20181231 70108-005_383b6995-6200-61a2-e054-00144ff8d46c 70108-005 HUMAN OTC DRUG Shopkins Brush Buddies Sodium Fluoride PASTE DENTAL 20160722 OTC MONOGRAPH FINAL part355 Ashtel Studios Inc. SODIUM FLUORIDE 2.4 mg/100g N 20181231 70108-006_3dbbb52d-eb38-1049-e054-00144ff8d46c 70108-006 HUMAN OTC DRUG Shopkins 3D Hand Sanitizer 6 pack Ethyl Alcohol 62% GEL TOPICAL 20160812 OTC MONOGRAPH NOT FINAL part333E Ashtel Studios Inc. ALCOHOL 62 g/59g N 20181231 70108-007_3a5f1d2d-f4e3-60b7-e054-00144ff8d46c 70108-007 HUMAN OTC DRUG Trolls Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160817 OTC MONOGRAPH NOT FINAL part333E Ashtel Studios, Inc. ALCOHOL 62 g/29mL N 20181231 70108-008_3e370570-32f7-3466-e054-00144ff8d46c 70108-008 HUMAN OTC DRUG Shopkins Mouth wash Sodium Fluoride LIQUID DENTAL 20161006 OTC MONOGRAPH FINAL part355 Ashtel Studios Inc. SODIUM FLUORIDE .05 mg/100g N 20181231 70108-009_208ef5e2-f32c-45cb-8e93-e68a15cd26cf 70108-009 HUMAN OTC DRUG THOMAS AND FRIENDS HAND SANITIZER CHLOROXYLENOL LIQUID TOPICAL 20170606 OTC MONOGRAPH NOT FINAL part333A Ashtel Studios, Inc CHLOROXYLENOL .05 g/100mL N 20181231 70108-010_b30e0def-0040-4d37-9ea6-d35b37ae12ec 70108-010 HUMAN OTC DRUG Shopkins HAND SANITIZER CHLOROXYLENOL LIQUID TOPICAL 20171116 OTC MONOGRAPH NOT FINAL part333A Ashtel Studios, Inc. CHLOROXYLENOL .05 g/100mL N 20181231 70108-100_566faaaf-2ef0-3d54-e054-00144ff88e88 70108-100 HUMAN OTC DRUG ANTISEPTIC WIPE benzalkonium chloride CLOTH TOPICAL 20170803 OTC MONOGRAPH NOT FINAL part333A Ashtel Studios Inc. BENZALKONIUM CHLORIDE .133 g/100g N 20181231 70108-501_a79b8c3d-2a7f-49d9-9a81-50ffc4e86c15 70108-501 HUMAN OTC DRUG Brushbuddies Shopkins Anticavity Tooth SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20161128 OTC MONOGRAPH FINAL part355 Ashtel Studio Inc SODIUM MONOFLUOROPHOSPHATE .066 g/100g N 20181231 70108-502_70f288f2-434d-4b2d-8372-ebb12a05b905 70108-502 HUMAN OTC DRUG Brushbuddies Shopkins Anticavity Fluoride SODIUM FLUORIDE MOUTHWASH ORAL 20161128 OTC MONOGRAPH FINAL part355 Ashtel Studio Inc SODIUM FLUORIDE .0225 g/100g N 20181231 70112-150_505c6f72-1b25-6236-e054-00144ff8d46c 70112-150 HUMAN OTC DRUG LevigoLT lidocaine/menthol cream CREAM TOPICAL 20170509 OTC MONOGRAPH NOT FINAL part348 Topicare Management, LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 4; 1 g/100g; g/100g N 20181231 70113-011_bdcec1f9-775f-4d98-8783-14340445fd98 70113-011 HUMAN OTC DRUG Abdominal Cream Bellis perennis, Calendula Officinalis CREAM TOPICAL 20160101 UNAPPROVED HOMEOPATHIC Homeopathic Services Inc. BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP 12; 12 [hp_X]/g; [hp_X]/g N 20181231 70113-021_83d25bc3-5401-4337-91f2-f841e0951938 70113-021 HUMAN OTC DRUG Muscle Gel 155-250 Arnica Montana, Magnesium Sulphuricum, Rhus Toxicodendron GEL TOPICAL 20160101 UNAPPROVED HOMEOPATHIC Homeopathic Services Inc. ARNICA MONTANA; MAGNESIUM SULFATE HEPTAHYDRATE; TOXICODENDRON PUBESCENS LEAF 12; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g N 20181231 70113-031_560c5327-ec87-48bd-8bb4-f27323f11d3b 70113-031 HUMAN OTC DRUG Knee Gel Rebound Manganum carbonicum, Ruta graveolens, Baryta carbonica, Rhus toxicodendron, Calcarea fluorica GEL TOPICAL 20160101 UNAPPROVED HOMEOPATHIC Homeopathic Services Inc. MANGANESE CARBONATE; RUTA GRAVEOLENS FLOWERING TOP; BARIUM CARBONATE; TOXICODENDRON PUBESCENS LEAF; CALCIUM FLUORIDE 30; 12; 12; 12; 12 [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g N 20181231 70116-001_fb6fde91-0a11-4eaf-b2d6-55a01d1d2ae1 70116-001 HUMAN OTC DRUG Eezy Sun SPF 30 Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20171214 OTC MONOGRAPH NOT FINAL part352 BIO EARTH MANUFACTURING (PTY) LTD MERADIMATE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 30; 75; 40; 50; 90 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 70116-002_fb6fde91-0a11-4eaf-b2d6-55a01d1d2ae1 70116-002 HUMAN OTC DRUG Eezy Sun SPF 50 Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20171214 OTC MONOGRAPH NOT FINAL part352 BIO EARTH MANUFACTURING (PTY) LTD MERADIMATE; OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 50; 75; 80; 70; 110 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 70117-001_a9df4a5e-3c87-4a4d-9af7-2561324bd4ff 70117-001 HUMAN OTC DRUG MAKEUP SUN PRIMER OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20151208 OTC MONOGRAPH NOT FINAL part352 STW ENTERPRISE INC. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 3.5; 2.47; 2.06 mg/50mL; mg/50mL; mg/50mL E 20171231 70118-001_2046706f-7b5d-1198-e054-00144ff8d46c 70118-001 HUMAN OTC DRUG PainKoolers Topical Analgesic Patch menthol and capsaicin PATCH TOPICAL 20150921 OTC MONOGRAPH NOT FINAL part348 GA Health and Beauty (FOSHAN) Co., Ltd MENTHOL; CAPSAICIN 5; .05 g/g; g/g E 20171231 70118-002_25c58c92-0362-0e8e-e054-00144ff8d46c 70118-002 HUMAN OTC DRUG PainKoolers Topical Analgesic MENTHOL, UNSPECIFIED FORM, CAPSAICIN GEL TOPICAL 20151121 OTC MONOGRAPH NOT FINAL part348 GA Health and Beauty (FOSHAN) Co., Ltd MENTHOL, UNSPECIFIED FORM; CAPSAICIN 5; .05 g/100g; g/100g E 20171231 70121-1000_0bc3c4b7-4d68-4632-b72c-d219ed006c48 70121-1000 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate Methylprednisolone INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161111 ANDA ANDA207549 Amneal Biosciences METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70121-1001_0bc3c4b7-4d68-4632-b72c-d219ed006c48 70121-1001 HUMAN PRESCRIPTION DRUG Methylprednisolone Sodium Succinate Methylprednisolone INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161111 ANDA ANDA207549 Amneal Biosciences METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/2mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70121-1002_8870ef60-feaa-4a33-84e6-1b630b1ecbdf 70121-1002 HUMAN PRESCRIPTION DRUG Eptifibatide Eptifibatide INJECTION INTRAVENOUS 20161208 ANDA ANDA205581 Amneal Biosciences EPTIFIBATIDE 2 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 70121-1003_8870ef60-feaa-4a33-84e6-1b630b1ecbdf 70121-1003 HUMAN PRESCRIPTION DRUG Eptifibatide Eptifibatide INJECTION INTRAVENOUS 20161208 ANDA ANDA205581 Amneal Biosciences EPTIFIBATIDE .75 mg/mL Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 70121-1033_02fc2875-d0e4-4ec3-9149-c0b79c1ed89d 70121-1033 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION INTRAVENOUS 20170309 ANDA ANDA206699 Amneal Biosciences PARICALCITOL 2 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 70121-1034_02fc2875-d0e4-4ec3-9149-c0b79c1ed89d 70121-1034 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION INTRAVENOUS 20170309 ANDA ANDA206699 Amneal Biosciences PARICALCITOL 5 ug/mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 70121-1035_02fc2875-d0e4-4ec3-9149-c0b79c1ed89d 70121-1035 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION INTRAVENOUS 20170309 ANDA ANDA206699 Amneal Biosciences PARICALCITOL 10 ug/2mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 70121-1036_02fc2875-d0e4-4ec3-9149-c0b79c1ed89d 70121-1036 HUMAN PRESCRIPTION DRUG Paricalcitol Paricalcitol INJECTION INTRAVENOUS 20170309 ANDA ANDA206699 Amneal Biosciences PARICALCITOL 10 ug/2mL Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20181231 70121-1037_0d38a4b8-5c5d-45b1-80ea-c5dc31faf5fc 70121-1037 HUMAN PRESCRIPTION DRUG Argatroban Argatroban INJECTION, SOLUTION INTRAVENOUS 20180126 ANDA ANDA206698 Amneal Biosciences LLC ARGATROBAN 100 mg/mL Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA] N 20191231 70121-1049_d029d07c-b851-417f-903b-3dd9ba26e7eb 70121-1049 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20171211 ANDA ANDA207550 Amneal Biosciences LLC TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70121-1076_6a57e904-0f67-4cb4-8afc-e0d408e8dbde 70121-1076 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAMUSCULAR; INTRAVENOUS 20160725 ANDA ANDA207552 Amneal Biosciences FUROSEMIDE 100 mg/10mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70121-1099_ec496297-5657-4dd1-a9fe-7044365eb6b5 70121-1099 HUMAN PRESCRIPTION DRUG Levoleucovorin Levoleucovorin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170213 ANDA ANDA207547 Amneal Biosciences LEVOLEUCOVORIN CALCIUM 50 mg/1 N 20181231 70121-1163_6a57e904-0f67-4cb4-8afc-e0d408e8dbde 70121-1163 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAMUSCULAR; INTRAVENOUS 20160725 ANDA ANDA207552 Amneal Biosciences FUROSEMIDE 20 mg/2mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70121-1164_6a57e904-0f67-4cb4-8afc-e0d408e8dbde 70121-1164 HUMAN PRESCRIPTION DRUG Furosemide Furosemide INJECTION INTRAMUSCULAR; INTRAVENOUS 20160725 ANDA ANDA207552 Amneal Biosciences FUROSEMIDE 40 mg/4mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70121-1168_d029d07c-b851-417f-903b-3dd9ba26e7eb 70121-1168 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20171211 ANDA ANDA207550 Amneal Biosciences LLC TRIAMCINOLONE ACETONIDE 200 mg/5mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70121-1169_d029d07c-b851-417f-903b-3dd9ba26e7eb 70121-1169 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20171211 ANDA ANDA207550 Amneal Biosciences LLC TRIAMCINOLONE ACETONIDE 400 mg/10mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70121-1189_8bf58b10-f68b-45ed-bdcc-1cbdf28da84b 70121-1189 HUMAN PRESCRIPTION DRUG Sodium nitroprusside Sodium nitroprusside INJECTION INTRAVENOUS 20171107 ANDA ANDA209493 Amneal Biosciences LLC SODIUM NITROPRUSSIDE 25 mg/mL Vasodilation [PE],Vasodilator [EPC] N 20181231 70121-1218_f7aba497-daea-4b5d-bc2d-687ea6f20243 70121-1218 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170217 ANDA ANDA208888 Amneal Biosciences DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 70121-1219_f7aba497-daea-4b5d-bc2d-687ea6f20243 70121-1219 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride Doxorubicin Hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170217 ANDA ANDA208888 Amneal Biosciences DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 70121-1221_7ec065b3-0085-4ffe-a31e-d44ed692047b 70121-1221 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION INTRAVENOUS 20180119 ANDA ANDA209640 Amneal Biosciences LLC DOCETAXEL ANHYDROUS 20 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20191231 70121-1222_7ec065b3-0085-4ffe-a31e-d44ed692047b 70121-1222 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION INTRAVENOUS 20180119 ANDA ANDA209640 Amneal Biosciences LLC DOCETAXEL ANHYDROUS 80 mg/4mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20191231 70121-1223_7ec065b3-0085-4ffe-a31e-d44ed692047b 70121-1223 HUMAN PRESCRIPTION DRUG Docetaxel Docetaxel INJECTION INTRAVENOUS 20180119 ANDA ANDA209640 Amneal Biosciences LLC DOCETAXEL ANHYDROUS 160 mg/8mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20191231 70121-1236_03fa52bc-9691-4d08-9fc3-252bb19f8607 70121-1236 HUMAN PRESCRIPTION DRUG Clofarabine Clofarabine INJECTION INTRAVENOUS 20171106 ANDA ANDA208857 Amneal Biosciences LLC CLOFARABINE 1 mg/mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20181231 70121-1244_f47ceb4b-5cf6-44ea-8079-cbcb42b531f1 70121-1244 HUMAN PRESCRIPTION DRUG Busulfan Busulfan INJECTION INTRAVENOUS 20171218 ANDA ANDA209580 Amneal Biosciences LLC BUSULFAN 6 mg/mL Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 70121-1381_7854667f-dc23-4499-b5cf-895e2eb4251e 70121-1381 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin INJECTION INTRAMUSCULAR; INTRAVENOUS 20160725 ANDA ANDA078476 Amneal Biosciences FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 70121-1390_7854667f-dc23-4499-b5cf-895e2eb4251e 70121-1390 HUMAN PRESCRIPTION DRUG Fosphenytoin Sodium Fosphenytoin INJECTION INTRAMUSCULAR; INTRAVENOUS 20160725 ANDA ANDA078476 Amneal Biosciences FOSPHENYTOIN SODIUM 50 mg/mL Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 70121-1392_036fc5e5-a78b-44f2-bcb4-b72f4d7ddd69 70121-1392 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol INJECTION, SOLUTION INTRAVENOUS 20170524 ANDA ANDA208974 Amneal Biosciences DOXERCALCIFEROL 4 ug/2mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 70121-1393_036fc5e5-a78b-44f2-bcb4-b72f4d7ddd69 70121-1393 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol INJECTION, SOLUTION INTRAVENOUS 20170524 ANDA ANDA208974 Amneal Biosciences DOXERCALCIFEROL 2 ug/mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 70121-1394_b734c440-5971-4294-8620-7c9284b476c6 70121-1394 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20170615 ANDA ANDA208973 Amneal Biosciences GLYCOPYRROLATE .2 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70121-1395_b734c440-5971-4294-8620-7c9284b476c6 70121-1395 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20170615 ANDA ANDA208973 Amneal Biosciences GLYCOPYRROLATE .4 mg/2mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70121-1396_b734c440-5971-4294-8620-7c9284b476c6 70121-1396 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20170615 ANDA ANDA208973 Amneal Biosciences GLYCOPYRROLATE 1 mg/5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70121-1397_b734c440-5971-4294-8620-7c9284b476c6 70121-1397 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate INJECTION INTRAMUSCULAR; INTRAVENOUS 20170615 ANDA ANDA208973 Amneal Biosciences GLYCOPYRROLATE 4 mg/20mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70121-1398_c1c8c5f2-cad3-458d-bc00-3df3cfe122b9 70121-1398 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20170228 ANDA ANDA208840 Amneal Biosciences TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 70121-1408_5ee3e070-8212-4c9b-8d45-3c3ddee52d3e 70121-1408 HUMAN PRESCRIPTION DRUG Doxercalciferol Doxercalciferol INJECTION, SOLUTION INTRAVENOUS 20170524 ANDA ANDA208975 Amneal Biosciences DOXERCALCIFEROL 4 ug/2mL Ergocalciferols [Chemical/Ingredient],Vitamin D2 Analog [EPC] N 20181231 70121-1453_5efff9a6-0ae5-447a-9c38-5fb7d9dfe7a5 70121-1453 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160509 ANDA ANDA205883 Amneal Biosciences LLC MEROPENEM 1 g/30mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 70121-1454_5efff9a6-0ae5-447a-9c38-5fb7d9dfe7a5 70121-1454 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20160509 ANDA ANDA205883 Amneal Biosciences LLC MEROPENEM 500 mg/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 70121-1567_12921a48-db2b-4520-a2d6-1dacade3002e 70121-1567 HUMAN PRESCRIPTION DRUG Bleomycin Bleomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRA-ARTERIAL; INTRAMUSCULAR; INTRAVENOUS 20160620 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Amneal Biosciences BLEOMYCIN SULFATE 15000 [iU]/1 Cytoprotective Agent [EPC] N 20181231 70121-1572_702f5f81-ea63-4a0f-bb93-46ccd94d0e80 70121-1572 HUMAN PRESCRIPTION DRUG Levoleucovorin Calcium Levoleucovorin INJECTION, SOLUTION INTRAVENOUS 20170908 ANDA ANDA207548 Amneal Biosciences LEVOLEUCOVORIN CALCIUM 10 mg/mL N 20181231 70121-1630_5780d136-25f0-2988-e053-2a91aa0a2ac1 70121-1630 HUMAN PRESCRIPTION DRUG TEPADINA THIOTEPA INJECTION, POWDER, FOR SOLUTION INTRACAVITARY; INTRAVENOUS; INTRAVESICAL 20170815 NDA NDA208264 Amneal Biosciences LLC THIOTEPA 15 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 70121-1631_5780d136-25f0-2988-e053-2a91aa0a2ac1 70121-1631 HUMAN PRESCRIPTION DRUG TEPADINA THIOTEPA INJECTION, POWDER, FOR SOLUTION INTRACAVITARY; INTRAVENOUS; INTRAVESICAL 20170815 NDA NDA208264 Amneal Biosciences LLC THIOTEPA 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 70123-001_56e04db0-a4e6-322b-e054-00144ff88e88 70123-001 HUMAN OTC DRUG DeVita Natural Skincare Solar Body Moisturizer Broad Spectrum SPF30 Mineral Sunscreen ZINC OXIDE CREAM TOPICAL 20151016 20190201 OTC MONOGRAPH NOT FINAL part352 DeVita Int'l Inc. ZINC OXIDE 190 mg/mL N 20181231 70123-101_56e04db0-a4e7-322b-e054-00144ff88e88 70123-101 HUMAN OTC DRUG Devita Natural Skin Care Solar Protective Moisturizer Broad Spectrum SPF 30 Mineral Sunscreen ZINC OXIDE CREAM TOPICAL 20151117 20190501 OTC MONOGRAPH NOT FINAL part352 Devita International Inc ZINC OXIDE 190 mg/mL N 20181231 70124-110_225371d6-5a66-6fac-e054-00144ff88e88 70124-110 HUMAN OTC DRUG Hand Sanitizer Ethanol LIQUID TOPICAL 20150720 OTC MONOGRAPH NOT FINAL part333E Sloan Valve Company ALCOHOL 71 mL/100mL N 20181231 70129-001_e0ddec7d-b2c6-44ee-95af-0e76fb73cc83 70129-001 HUMAN OTC DRUG BEAUTY FOX ATOCLINIC DIMETHICONE CREAM TOPICAL 20150930 OTC MONOGRAPH FINAL part347 Beauty Fox Co., Ltd. DIMETHICONE 1.6 g/160g E 20171231 70129-002_af27dc85-4d3d-40f6-b9d8-f1590bddade0 70129-002 HUMAN OTC DRUG BEAUTY FOX ATOCLINIC ALLANTOIN LOTION TOPICAL 20150930 UNAPPROVED DRUG OTHER Beauty Fox Co., Ltd. ALLANTOIN .25 g/250g E 20171231 70130-001_04055c9b-f806-4af4-b7e5-d1fbfe5dbf6e 70130-001 HUMAN OTC DRUG Kimchi Lactic Acid 1000 Lactobacillus Plantarum GRANULE ORAL 20151014 UNAPPROVED DRUG OTHER Biogenicskorea Co., LTD LACTOBACILLUS PLANTARUM .101 g/1.5g E 20171231 70130-002_bcdaeca2-f68e-4e21-b115-6cb41ada3a84 70130-002 HUMAN OTC DRUG Kimchi Lactobacillus 1000 Lactobacillus Plantarum GRANULE ORAL 20151111 UNAPPROVED DRUG OTHER Biogenicskorea Co., LTD LACTOBACILLUS PLANTARUM .04 g/1.5g E 20171231 70130-003_b5eb22e8-7ca2-469a-a255-8c0519915825 70130-003 HUMAN OTC DRUG Kimchi Lactobacillus 2000 Lactobacillus Plantarum GRANULE ORAL 20151111 UNAPPROVED DRUG OTHER Biogenicskorea Co., LTD LACTOBACILLUS PLANTARUM .08 g/1.5g E 20171231 70133-001_f353a8c9-c909-458b-9e5c-da24ef3f620a 70133-001 HUMAN OTC DRUG NIVEOLA 3D ANIMAL CAT MASK PACK Adenosine CREAM TOPICAL 20151008 UNAPPROVED DRUG OTHER Unisource International Co., Ltd. ADENOSINE .01 g/27g E 20171231 70133-002_1793833a-3035-442b-9c53-bfc38dd1c2c7 70133-002 HUMAN OTC DRUG NIVEOLA 3D ANIMAL DOG MASK PACK Adenosine CREAM TOPICAL 20151008 UNAPPROVED DRUG OTHER Unisource International Co., Ltd. ADENOSINE .01 g/27g E 20171231 70133-003_2de28f08-cbf6-4614-8c6a-7868ed83faa5 70133-003 HUMAN OTC DRUG NIVEOLA P.H.C 3D FESTIVAL MASK PACK Niacinamide CREAM TOPICAL 20151008 UNAPPROVED DRUG OTHER Unisource International Co., Ltd. NIACINAMIDE .54 g/27g E 20171231 70133-004_1d9c6873-73e8-4008-8eca-8627c8c35a3c 70133-004 HUMAN OTC DRUG NIVEOLA WHITE TIGER 3D ANIMAL MASK PACK Niacinamide CREAM TOPICAL 20151008 UNAPPROVED DRUG OTHER Unisource International Co., Ltd. NIACINAMIDE .54 g/27g E 20171231 70136-101_5e944230-9ddd-439f-959e-0ce12fbc409c 70136-101 HUMAN OTC DRUG Calfarme FOAM CARE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20151006 OTC MONOGRAPH NOT FINAL part333A Calfarme (singapore) Pte.Ltd BENZALKONIUM CHLORIDE 20 g/L E 20171231 70140-001_5b34aa4c-7262-4756-e053-2a91aa0a27d9 70140-001 HUMAN OTC DRUG Wet Wipes Benzalkonium chloride SWAB TOPICAL 20160606 OTC MONOGRAPH NOT FINAL part333A GULSAH URETIM PAZARLAMA - HUSEY IN KAYA BENZALKONIUM CHLORIDE .1 g/1 N 20181231 70141-010_b6a1fcd9-6d25-49d8-9cc4-97720d742b2b 70141-010 HUMAN OTC DRUG AT Alpha Glycerin CREAM TOPICAL 20150901 UNAPPROVED DRUG OTHER SALOJE Inc GLYCERIN 5 mg/50mL N 20181231 70141-020_4a07e442-12fe-4edf-9a06-b8aacffaecec 70141-020 HUMAN OTC DRUG AT Alpha Plus Glycerin CREAM TOPICAL 20150901 UNAPPROVED DRUG OTHER SALOJE Inc GLYCERIN 4 mg/40mL N 20181231 70141-030_2618761b-a1f5-4450-a507-d4df2ec91485 70141-030 HUMAN OTC DRUG Peptide Easter Glycerin EMULSION TOPICAL 20150901 UNAPPROVED DRUG OTHER SALOJE Inc GLYCERIN 3.5 mg/35mL N 20181231 70142-001_ffda612c-342e-4cd0-a1c4-caaee83a2a0b 70142-001 HUMAN OTC DRUG SNP Animal Panda Luminous Cover Cushion TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20161016 OTC MONOGRAPH NOT FINAL part352 SD BIOTECHNOLOGIES CO., LTD TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.0752; .84; .36 g/12g; g/12g; g/12g E 20171231 70142-002_3306996d-b0dd-4d88-a4db-64395fec233c 70142-002 HUMAN OTC DRUG SNP Animal Tiger Long-lasting Cover Cushion TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20161016 OTC MONOGRAPH NOT FINAL part352 SD BIOTECHNOLOGIES CO., LTD TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.4592; .84; .36 g/12g; g/12g; g/12g E 20171231 70143-1000_2f654db2-2866-12c6-e054-00144ff88e88 70143-1000 HUMAN OTC DRUG Sanitizer Alcohol SPRAY TOPICAL 20151208 OTC MONOGRAPH NOT FINAL part333A Gandang Kalikasan USA Inc. ALCOHOL 60 mL/100mL N 20181231 70143-1001_2f689d69-0e5d-20d4-e054-00144ff88e88 70143-1001 HUMAN OTC DRUG Sanitizer Alcohol SPRAY TOPICAL 20151208 OTC MONOGRAPH NOT FINAL part333A Gandang Kalikasan USA Inc. ALCOHOL 60 mL/100mL N 20181231 70143-1002_2f68b55f-bfa7-2b64-e054-00144ff8d46c 70143-1002 HUMAN OTC DRUG Sanitizer Alcohol SPRAY TOPICAL 20151208 OTC MONOGRAPH NOT FINAL part333A Gandang Kalikasan USA Inc. ALCOHOL 60 mL/100mL N 20181231 70143-1003_2f68280f-7e2c-0e66-e054-00144ff88e88 70143-1003 HUMAN OTC DRUG Sanitizer Alcohol SPRAY TOPICAL 20151208 OTC MONOGRAPH NOT FINAL part333A Gandang Kalikasan USA Inc. ALCOHOL 60 mL/100mL N 20181231 70146-000_29b87313-50f8-182a-e054-00144ff8d46c 70146-000 HUMAN OTC DRUG Relief Balm camphor, eucalyptus oil, menthol, methyl salicylate CREAM TOPICAL 20151015 OTC MONOGRAPH NOT FINAL part348 Dr.Sankunni's Ayurvedic Research Foundation Private Limited CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 11; 10; 10; 10 g/100g; g/100g; g/100g; g/100g N 20181231 70146-001_29b84b94-bd9a-62b2-e054-00144ff88e88 70146-001 HUMAN OTC DRUG Womens Relief Balm camphor, eucalyptus oil, menthol, methyl salicylate CREAM TOPICAL 20151015 OTC MONOGRAPH NOT FINAL part348 Dr.Sankunni's Ayurvedic Research Foundation Private Limited CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 11; 10; 10; 10 g/100g; g/100g; g/100g; g/100g N 20181231 70146-002_29b8cfb7-4ce1-03d0-e054-00144ff88e88 70146-002 HUMAN OTC DRUG Sports Balm camphor, eucalyptus oil, menthol, methyl salicylate CREAM TOPICAL 20151015 OTC MONOGRAPH NOT FINAL part348 Dr.Sankunni's Ayurvedic Research Foundation Private Limited CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 11; 10; 10; 10 g/100g; g/100g; g/100g; g/100g N 20181231 70146-003_29b8e3ae-3005-3a96-e054-00144ff8d46c 70146-003 HUMAN OTC DRUG Womens Sports Balm camphor, eucalyptus oil, menthol, methyl salicylate CREAM TOPICAL 20151015 OTC MONOGRAPH NOT FINAL part348 Dr.Sankunni's Ayurvedic Research Foundation Private Limited CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 11; 10; 10; 10 g/100g; g/100g; g/100g; g/100g N 20181231 70146-004_3cf8e55a-8409-2f5f-e054-00144ff88e88 70146-004 HUMAN OTC DRUG Relief Balm camphor, eucalyptus oil, menthol CREAM TOPICAL 20160721 OTC MONOGRAPH NOT FINAL part348 Dr.Sankunni's Ayurvedic Research Foundation Private Limited CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 11; 10; 8 g/100g; g/100g; g/100g N 20181231 70146-005_3cf8e55a-8412-2f5f-e054-00144ff88e88 70146-005 HUMAN OTC DRUG Sports Balm camphor, eucalyptus oil, menthol CREAM TOPICAL 20160721 OTC MONOGRAPH NOT FINAL part348 Dr.Sankunni's Ayurvedic Research Foundation Private Limited CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 11; 10; 8 g/100g; g/100g; g/100g N 20181231 70146-006_3cf915fb-3709-1a34-e054-00144ff8d46c 70146-006 HUMAN OTC DRUG Womens Relief Balm camphor, eucalyptus oil, menthol CREAM TOPICAL 20160721 OTC MONOGRAPH NOT FINAL part348 Dr.Sankunni's Ayurvedic Research Foundation Private Limited CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 11; 10; 8 g/100g; g/100g; g/100g N 20181231 70146-007_3cf8e55a-841b-2f5f-e054-00144ff88e88 70146-007 HUMAN OTC DRUG Womens Sports Balm camphor, eucalyptus oil, menthol CREAM TOPICAL 20160721 OTC MONOGRAPH NOT FINAL part348 Dr.Sankunni's Ayurvedic Research Foundation Private Limited CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 11; 10; 8 g/100g; g/100g; g/100g N 20181231 70146-008_3fb880cc-d192-3cec-e054-00144ff88e88 70146-008 HUMAN OTC DRUG Relief Balm camphor, eucalyptus oil, menthol, methyl salicylate CREAM TOPICAL 20161025 OTC MONOGRAPH NOT FINAL part348 Dr.Sankunni's Ayurvedic Research Foundation Private Limited CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 11; 10; 8; 10 g/100g; g/100g; g/100g; g/100g N 20181231 70146-009_3fb8923d-bfc0-3cc7-e054-00144ff88e88 70146-009 HUMAN OTC DRUG Sports Balm camphor, eucalyptus oil, menthol, methyl salicylate CREAM TOPICAL 20161025 OTC MONOGRAPH NOT FINAL part348 Dr.Sankunni's Ayurvedic Research Foundation Private Limited CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 11; 10; 8; 10 g/100g; g/100g; g/100g; g/100g N 20181231 70146-010_3fb925e5-44cc-446b-e054-00144ff8d46c 70146-010 HUMAN OTC DRUG Womens Relief Balm camphor, eucalyptus oil, menthol, methyl salicylate CREAM TOPICAL 20161025 OTC MONOGRAPH NOT FINAL part348 Dr.Sankunni's Ayurvedic Research Foundation Private Limited CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 11; 10; 8; 10 g/100g; g/100g; g/100g; g/100g N 20181231 70146-011_3fb925e5-44db-446b-e054-00144ff8d46c 70146-011 HUMAN OTC DRUG Womens Sports Balm camphor, eucalyptus oil, menthol, methyl salicylate CREAM TOPICAL 20161025 OTC MONOGRAPH NOT FINAL part348 Dr.Sankunni's Ayurvedic Research Foundation Private Limited CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL; METHYL SALICYLATE 11; 10; 8; 10 g/100g; g/100g; g/100g; g/100g N 20181231 70147-222_8a488a0b-e95e-4f4c-9e49-9282ad17ce9e 70147-222 HUMAN OTC DRUG Glenmax PEB PHENYLEPHRINE HYDROCHLORIDE and BROMPHENIRAMINE MALEATE SYRUP ORAL 20151205 OTC MONOGRAPH FINAL part341 Glendale Inc PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 10; 4 mg/5mL; mg/5mL E 20171231 70147-223_a072f9ee-7b72-4c8f-81db-9f0b2e022a67 70147-223 HUMAN OTC DRUG Glenmax PEB DM FORTE DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and BROMPHENIRAMINE MALEATE SYRUP ORAL 20151205 OTC MONOGRAPH FINAL part341 Glendale Inc DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 20; 10; 4 mg/5mL; mg/5mL; mg/5mL E 20171231 70147-224_00300957-6051-4c1f-b806-c62368dbe1f1 70147-224 HUMAN OTC DRUG Glen PE PHENYLEPHRINE HYDROCHLORIDE and PYRILAMINE MALEATE SYRUP ORAL 20151205 OTC MONOGRAPH FINAL part341 Glendale Inc PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE 15; 16 mg/5mL; mg/5mL E 20171231 70147-230_7fe86587-1b8a-46c4-bb15-0882d3cf141c 70147-230 HUMAN OTC DRUG Glenmax PEB DM DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, and BROMPHENIRAMINE MALEATE SYRUP ORAL 20151205 OTC MONOGRAPH FINAL part341 Glendale Inc DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE 10; 5; 2 mg/5mL; mg/5mL; mg/5mL E 20171231 70147-233_f23182eb-a618-4556-a265-3de318cc7ae5 70147-233 HUMAN OTC DRUG Glentuss DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DOXYLAMINE SUCCINATE SYRUP ORAL 20151205 OTC MONOGRAPH FINAL part341 Glendale Inc DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE 15; 30; 6.25 mg/5mL; mg/5mL; mg/5mL E 20171231 70147-313_875023fe-56af-4434-83d2-a614461955b3 70147-313 HUMAN OTC DRUG Coditussin AC CODEINE PHOSPHATE and GUAIFENESIN SYRUP ORAL 20160501 OTC MONOGRAPH FINAL part341 Glendale Inc CODEINE PHOSPHATE; GUAIFENESIN 10; 200 mg/5mL; mg/5mL E 20171231 70147-414_5a3c4507-724c-4145-8d32-be791e9c6fa4 70147-414 HUMAN OTC DRUG Coditussin DAC CODEINE PHOSPHATE, GUAIFENESIN, and PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP ORAL 20160501 OTC MONOGRAPH FINAL part341 Glendale Inc CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 10; 200; 30 mg/5mL; mg/5mL; mg/5mL E 20171231 70148-001_cffca71e-589d-4880-8e9d-07185164ab6b 70148-001 HUMAN PRESCRIPTION DRUG Sky-Living Water MT Activition Liquid IODINE LIQUID ORAL 20151015 UNAPPROVED DRUG OTHER WINGS BIOMEDICAL TECHNOLOGY CO., LTD. IODINE 2.5 g/100mL E 20171231 70149-699_47f4f989-fac4-6576-e054-00144ff8d46c 70149-699 HUMAN OTC DRUG Deter Outdoor Skin Protection Natural Mineral Sunscreen SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20151003 OTC MONOGRAPH NOT FINAL part352 Mariner Biomedical Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 70151-001_97c989b4-ff55-45a0-8782-f8c8b6e520be 70151-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20151115 NDA NDA205712 Central Welding Supply Company OXYGEN 990 mL/L N 20181231 70151-003_60ad0ffa-ee7d-4215-e053-2a91aa0ab4ca 70151-003 HUMAN PRESCRIPTION DRUG Air Air GAS RESPIRATORY (INHALATION) 20151115 NDA NDA205712 Central Welding Supply Company OXYGEN 210 mL/L N 20181231 70151-004_ac627d45-610a-44be-bb15-e78d4e8446bb 70151-004 HUMAN PRESCRIPTION DRUG Nitrous Oxide Nitrous Oxide GAS RESPIRATORY (INHALATION) 20160301 NDA NDA205704 Central Welding Supply Company NITROUS OXIDE 990 mL/L N 20181231 70151-021_0424d2b3-97cd-4733-9e24-d354bd720f69 70151-021 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20151115 NDA NDA205713 Central Welding Supply Company NITROGEN 990 mL/L N 20181231 70156-107_0c6d3a8d-4346-430d-91c8-01728da8aafd 70156-107 HUMAN PRESCRIPTION DRUG Sodium Sulfacetamide 10% and Sulfur 5% Cleanser Sulfacetamide Sodium and Sulfur RINSE TOPICAL 20171211 UNAPPROVED DRUG OTHER Noble Pharmaceuticals, LLC SULFACETAMIDE SODIUM; SULFUR 10; 5 mg/g; mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 70156-111_b438fa69-fe3e-45bb-939b-cb10f805f23e 70156-111 HUMAN PRESCRIPTION DRUG Selenium Sulfide Selenium Sulfide SHAMPOO TOPICAL 20170509 UNAPPROVED DRUG OTHER Noble Pharmaceuticals, LLC SELENIUM SULFIDE 22.5 mg/mL N 20181231 70156-112_1e68f319-8711-4815-bc10-875f8f4a1213 70156-112 HUMAN OTC DRUG Codeine Phosphate and Guaifenesin codeine phosphate and guaifenesin LIQUID ORAL 20170117 OTC MONOGRAPH FINAL part341 Noble Pharmaceuticals, LLC CODEINE PHOSPHATE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL CV N 20181231 70157-002_c5428a19-eb07-4b41-9e88-c3dcbf5aece8 70157-002 HUMAN OTC DRUG City Sunscreen serum Broad Spectrum SPF 30 Supergoop Homosalate, Octisalate, Avobenzene, Octocrylene CREAM TOPICAL 20101207 OTC MONOGRAPH FINAL part352 Baxter Laboratories Pty. Ltd. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 8; 4; 3; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 70157-003_17fac339-3f06-477a-9e4b-d5ec51cd1722 70157-003 HUMAN OTC DRUG City Sunscreen serum Broad Spectrum SPF 30 Supergoop Homosalate, Octisalate, Avobenzene, Octocrylene CREAM TOPICAL 20101207 OTC MONOGRAPH FINAL part352 Baxter Laboratories HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 8; 4; 3; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 70157-004_16a60e46-531a-4e98-9c97-100a7ed6a78e 70157-004 HUMAN OTC DRUG City Sunscreen serum Broad Spectrum SPF 30 Supergoop Homosalate, Octisalate, Avobenzene, Octocrylene CREAM TOPICAL 20101207 OTC MONOGRAPH FINAL part352 Baxter Laboratories Pty. Ltd. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 8; 4; 3; 2 g/100kg; g/100kg; g/100kg; g/100kg N 20181231 70157-005_3201fb67-97e5-4c02-b7ff-a05527160704 70157-005 HUMAN OTC DRUG Soft Focus City Suncreen Serum Broad Spectrum SPF 30 Supergoop Avobenzone, Homosalate, Octisalate, Octocrylene LIQUID TOPICAL 20141230 OTC MONOGRAPH FINAL part352 Baxter Laboratories Pty. Ltd. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 8; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 70157-006_5f2d2652-b68e-421d-addb-bf891cd310b7 70157-006 HUMAN OTC DRUG Premium Natural Sunscreen Loition Baby Bum Zinc Oxide CREAM TOPICAL 20150427 OTC MONOGRAPH FINAL part352 Baxter Laboratories ZINC OXIDE 20 g/100mL N 20181231 70157-007_9840b7f2-5152-4d38-a01d-f261e3352991 70157-007 HUMAN OTC DRUG Premium Natural Sunscreen Broad Spectrum SPF 30 Baby Bum Zinc Oxide STICK TOPICAL 20150427 OTC MONOGRAPH FINAL part352 Baxter Laberatories ZINC OXIDE 20 g/100g N 20181231 70163-0001_d20e3d00-d16f-46e6-8bd2-b00fb71e5c58 70163-0001 HUMAN OTC DRUG Insomnia HP Arsenicum Album, Avena Sativa, Coffea Cruda, Kali Carbonicum, Magnesia Carbonica, Nux Vomica, Passiflora Incarnata, Sepia, Valeriana Officinalis LIQUID ORAL 20151123 UNAPPROVED HOMEOPATHIC Grato Holdings, Inc. ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; SEPIA OFFICINALIS JUICE; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 70164-010_6c90c4e2-3558-433b-bc87-79af911db9f2 70164-010 HUMAN OTC DRUG Clear QQ Sodium Fluoride PASTE, DENTIFRICE ORAL 20150901 OTC MONOGRAPH FINAL part355 YOURMG. CO. LTD SODIUM FLUORIDE .75 g/150g E 20171231 70165-003_4df2eebc-45bf-49a3-ae42-56b4c77905e5 70165-003 HUMAN PRESCRIPTION DRUG Adzenys ER Amphetamine SUSPENSION, EXTENDED RELEASE ORAL 20170916 NDA NDA204325 Neos Therapeutics, LP AMPHETAMINE 1.25 mg/mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 70165-005_5ef6ae53-6504-44b5-864c-3dd20edf60f1 70165-005 HUMAN PRESCRIPTION DRUG Adzenys XR-ODT Amphetamine TABLET, ORALLY DISINTEGRATING ORAL 20160216 NDA NDA204326 Neos Therapeutics, LP AMPHETAMINE 3.1 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 70165-010_5ef6ae53-6504-44b5-864c-3dd20edf60f1 70165-010 HUMAN PRESCRIPTION DRUG Adzenys XR-ODT Amphetamine TABLET, ORALLY DISINTEGRATING ORAL 20160216 NDA NDA204326 Neos Therapeutics, LP AMPHETAMINE 6.3 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 70165-015_5ef6ae53-6504-44b5-864c-3dd20edf60f1 70165-015 HUMAN PRESCRIPTION DRUG Adzenys XR-ODT Amphetamine TABLET, ORALLY DISINTEGRATING ORAL 20160216 NDA NDA204326 Neos Therapeutics, LP AMPHETAMINE 9.4 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 70165-020_5ef6ae53-6504-44b5-864c-3dd20edf60f1 70165-020 HUMAN PRESCRIPTION DRUG Adzenys XR-ODT Amphetamine TABLET, ORALLY DISINTEGRATING ORAL 20160216 NDA NDA204326 Neos Therapeutics, LP AMPHETAMINE 12.5 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 70165-025_5ef6ae53-6504-44b5-864c-3dd20edf60f1 70165-025 HUMAN PRESCRIPTION DRUG Adzenys XR-ODT Amphetamine TABLET, ORALLY DISINTEGRATING ORAL 20160216 NDA NDA204326 Neos Therapeutics, LP AMPHETAMINE 15.7 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 70165-030_5ef6ae53-6504-44b5-864c-3dd20edf60f1 70165-030 HUMAN PRESCRIPTION DRUG Adzenys XR-ODT Amphetamine TABLET, ORALLY DISINTEGRATING ORAL 20160216 NDA NDA204326 Neos Therapeutics, LP AMPHETAMINE 18.8 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 70165-100_8dfc75eb-b2cc-4187-8205-76f0e9a52a8b 70165-100 HUMAN PRESCRIPTION DRUG Cotempla XR-ODT Methylphenidate TABLET, ORALLY DISINTEGRATING ORAL 20160620 NDA NDA205489 Neos Therapeutics, LP METHYLPHENIDATE 8.6 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 70165-200_8dfc75eb-b2cc-4187-8205-76f0e9a52a8b 70165-200 HUMAN PRESCRIPTION DRUG Cotempla XR-ODT Methylphenidate TABLET, ORALLY DISINTEGRATING ORAL 20160620 NDA NDA205489 Neos Therapeutics, LP METHYLPHENIDATE 17.3 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 70165-300_8dfc75eb-b2cc-4187-8205-76f0e9a52a8b 70165-300 HUMAN PRESCRIPTION DRUG Cotempla XR-ODT Methylphenidate TABLET, ORALLY DISINTEGRATING ORAL 20160620 NDA NDA205489 Neos Therapeutics, LP METHYLPHENIDATE 25.9 mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 70166-492_615dce0a-f783-5067-e053-2a91aa0aca6e 70166-492 HUMAN PRESCRIPTION DRUG Oxycodone Hydrochloride Oxycodone Hydrochloride SOLUTION ORAL 20171227 ANDA ANDA204092 Lohxa OXYCODONE HYDROCHLORIDE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 70169-701_47f4f989-fb14-6576-e054-00144ff8d46c 70169-701 HUMAN OTC DRUG Formula45 Arthritis Blend METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM CREAM TOPICAL 20151016 OTC MONOGRAPH NOT FINAL part348 Shift Consulting Group, Inc. METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM 200; 100 mg/g; mg/g N 20181231 70170-0001_62bff8d1-59cf-46bc-9bde-8a6c4e9cd473 70170-0001 HUMAN OTC DRUG eos lip balm sunscreen broad spectrum spf 15 Avobenzone, Homosalate and Octocrylene STICK TOPICAL 20100831 OTC MONOGRAPH FINAL part352 eos Products LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE .21; .56; .2 g/7g; g/7g; g/7g E 20171231 70170-0002_62bff8d1-59cf-46bc-9bde-8a6c4e9cd473 70170-0002 HUMAN OTC DRUG eos lip balm sunscreen broad spectrum spf 15 Avobenzone, Homosalate and Octocrylene STICK TOPICAL 20100831 OTC MONOGRAPH FINAL part352 eos Products LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE .21; .56; .2 g/7g; g/7g; g/7g E 20171231 70170-0003_c1d62007-a05c-4b74-8e55-785550ca99e0 70170-0003 HUMAN OTC DRUG eos Medicated Pain Relieving Lip Balm Phenol STICK TOPICAL 20110831 OTC MONOGRAPH NOT FINAL part348 eos Products LLC PHENOL .68 g/7g E 20171231 70170-0004_c1d62007-a05c-4b74-8e55-785550ca99e0 70170-0004 HUMAN OTC DRUG eos Medicated Pain Relieving Lip Balm Phenol STICK TOPICAL 20110831 OTC MONOGRAPH NOT FINAL part348 eos Products LLC PHENOL .68 g/7g E 20171231 70170-0007_095196ed-e9cc-40bf-897f-23a02a91bb66 70170-0007 HUMAN OTC DRUG eos active protection lemon twist sunscreen lip balm broad spectrum spf 15 Avobenzone, Homosalate and Octocrylene STICK TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 eos Products LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE .21; .56; .35 g/7g; g/7g; g/7g N 20181231 70170-0008_095196ed-e9cc-40bf-897f-23a02a91bb66 70170-0008 HUMAN OTC DRUG eos active protection lemon twist sunscreen lip balm broad spectrum spf 15 Avobenzone, Homosalate and Octocrylene STICK TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 eos Products LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE .21; .56; .35 g/7g; g/7g; g/7g N 20181231 70170-0009_49b7ff4f-2092-4ee3-b409-4f8dea89fe71 70170-0009 HUMAN OTC DRUG eos active protection fresh grapefruit sunscreen lip balm broad spectrum spf 30 Avobenzone, Homosalate and Octocrylene STICK TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 eos Products LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE .21; .7; .7 g/7g; g/7g; g/7g N 20181231 70170-0010_49b7ff4f-2092-4ee3-b409-4f8dea89fe71 70170-0010 HUMAN OTC DRUG eos active protection fresh grapefruit sunscreen lip balm broad spectrum spf 30 Avobenzone, Homosalate and Octocrylene STICK TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 eos Products LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE .21; .7; .7 g/7g; g/7g; g/7g N 20181231 70172-001_62080932-0843-34fc-e053-2a91aa0a401b 70172-001 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Alabaster OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-002_62085e80-c932-18e5-e053-2a91aa0afba0 70172-002 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Porcelain OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-003_6208cc65-769d-7766-e053-2a91aa0a9039 70172-003 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Warm Ivory OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-004_6208ece6-7ec0-fd36-e053-2991aa0a603c 70172-004 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Almond Beige OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-005_62090f65-6598-ed89-e053-2a91aa0a7362 70172-005 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Cool Beige OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-006_6208ece6-7ecf-fd36-e053-2991aa0a603c 70172-006 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Warm Beige OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-007_62091dff-3e46-fd38-e053-2991aa0aee11 70172-007 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Ivory OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-008_62091dff-3e55-fd38-e053-2991aa0aee11 70172-008 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Cream OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-009_62091dff-3e64-fd38-e053-2991aa0aee11 70172-009 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Soft Sand OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-010_6208fec9-75ac-b5f6-e053-2a91aa0af899 70172-010 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Golden Beige OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-011_62092361-69a6-4320-e053-2991aa0a3642 70172-011 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen True Beige OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-012_6208fec9-75bb-b5f6-e053-2a91aa0af899 70172-012 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Honey OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP TITANIUM DIOXIDE; OCTINOXATE 16; 36 mg/mL; mg/mL N 20191231 70172-013_62437353-9987-cc8c-e053-2991aa0aa63a 70172-013 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Olive OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-014_62437353-9996-cc8c-e053-2991aa0aa63a 70172-014 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Caramel OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-015_62437353-99a5-cc8c-e053-2991aa0aa63a 70172-015 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Rose Beige OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-016_62438c87-ad7c-7a12-e053-2a91aa0a8efe 70172-016 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Amber OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-017_6243938a-4c56-321a-e053-2991aa0a2770 70172-017 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Topaz OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-018_62437353-99b4-cc8c-e053-2991aa0aa63a 70172-018 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Nougat OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-019_62437353-99c3-cc8c-e053-2991aa0aa63a 70172-019 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Chestnut OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70172-020_62437353-99d2-cc8c-e053-2991aa0aa63a 70172-020 HUMAN OTC DRUG All-Day Liquid Foundation SPF 15 sunscreen Ebony OCTINOXATE, TITANIUM DIOXIDE EMULSION TOPICAL 20160726 20190301 OTC MONOGRAPH NOT FINAL part352 H and M Hennes and Mauritz LP OCTINOXATE; TITANIUM DIOXIDE 36; 16 mg/mL; mg/mL N 20191231 70176-100_64ff8db4-4f08-4120-9c24-fac053c11d08 70176-100 HUMAN OTC DRUG Nasal Spa Natural Sea Salt SODIUM CHLORIDE SPRAY NASAL 20151029 UNAPPROVED DRUG OTHER NACUR HEALTHCARE LTD SODIUM CHLORIDE 9.5 mg/mL N 20181231 70183-125_bc19dd6b-f00d-4ea4-b92b-68fc2836c1eb 70183-125 HUMAN PRESCRIPTION DRUG Xermelo telotristat ethyl TABLET ORAL 20170301 NDA NDA208794 Lexicon Pharmaceuticals, Inc. TELOTRISTAT ETHYL 250 mg/1 Tryptophan Hydroxylase Inhibitor [EPC],Tryptophan Hydroxylase Inhibitors [MoA] N 20181231 70186-564_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-564 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-566_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-566 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-567_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-567 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-568_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-568 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-569_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-569 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-570_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-570 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-571_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-571 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-572_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-572 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-573_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-573 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-574_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-574 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-575_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-575 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-576_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-576 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-577_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-577 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-578_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-578 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70186-579_332ffc1f-1b0d-47c6-825f-6b86c0495b13 70186-579 HUMAN OTC DRUG Magic Foundation Flawless Long-Lasting Coverage Sunscreen Broad Spectrum SPF 15 Titanium Dioxide and Zinc Oxide SUSPENSION TOPICAL 20160222 OTC MONOGRAPH FINAL part352 Charlotte Tilbury Beauty Ltd. TITANIUM DIOXIDE; ZINC OXIDE .957; .282 g/30mL; g/30mL N 20181231 70188-001_6e0b564b-1a29-4666-98e4-104523ceaeba 70188-001 HUMAN OTC DRUG DermaNumb Tattoo Anesthetic Lidocaine HCL GEL TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part348 A.T.S. Laboratories, LLC LIDOCAINE HYDROCHLORIDE 40 mg/g N 20191231 70188-002_906ff0b1-8f99-4cb5-bcac-b412629cb259 70188-002 HUMAN OTC DRUG DermaNumb Tattoo Anesthetic Gel Lidocaine HCL GEL TOPICAL 20150701 OTC MONOGRAPH NOT FINAL part348 A.T.S. Laboratories, LLC LIDOCAINE HYDROCHLORIDE 40 mg/g N 20191231 70190-100_6b57af16-09af-452e-85c6-5dbd7cc7248e 70190-100 HUMAN OTC DRUG John Deere Instant Hand Sanitizer ALCOHOL GEL TOPICAL 20151101 OTC MONOGRAPH NOT FINAL part333E TIG Distributing, Inc. ALCOHOL 600 mL/1000mL E 20171231 70194-003_ca278606-3ce4-4745-9879-26992a45c910 70194-003 HUMAN PRESCRIPTION DRUG Trulance Immediate release Plecanatide TABLET ORAL 20170221 NDA NDA208745 Synergy Pharmaceuticals Inc. PLECANATIDE 3 mg/1 Guanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA] N 20181231 70196-1333_22c3f4dd-3554-37d1-e054-00144ff8d46c 70196-1333 HUMAN OTC DRUG Smartchoices Lanolin Plus 0 Lanolin CREAM TOPICAL 20101001 OTC MONOGRAPH FINAL part347 Florri Feme Pharmaceuticals Ltd LANOLIN 1 mg/50mg E 20171231 70197-103_bf5f58f9-ebda-4610-82ad-422cddcf9feb 70197-103 HUMAN OTC DRUG EAD Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20151029 OTC MONOGRAPH NOT FINAL part352 Arion Perfume & Beauty, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.4; 14.4; 6; 2.4; 2.4 g/120mL; g/120mL; g/120mL; g/120mL; g/120mL N 20181231 70198-101_a5c5336b-2ef6-4484-8e56-cb2f15a01479 70198-101 HUMAN OTC DRUG IDENEL Light R Tox Daily Niacinamide, Panthenol, Dimethicone CREAM TOPICAL 20151112 UNAPPROVED DRUG OTHER SR biotek Inc. NIACINAMIDE; PANTHENOL; DIMETHICONE .02; .01; .01 1/50mL; 1/50mL; 1/50mL E 20171231 70198-102_3bad92e5-836d-4ce5-87e6-37b290456a75 70198-102 HUMAN OTC DRUG IDENEL Revitalizing Eye Niacinamide, Panthenol, Dimethicone CREAM TOPICAL 20151114 UNAPPROVED DRUG OTHER SR biotek Inc. NIACINAMIDE; PANTHENOL; DIMETHICONE .02; .02; .01 1/30mL; 1/30mL; 1/30mL E 20171231 70199-006_00af0dea-ac7b-43f2-9f51-2a9f9e7f7d21 70199-006 HUMAN PRESCRIPTION DRUG Furadantin Nitrofurantoin SUSPENSION ORAL 20180122 NDA NDA009175 Casper Pharma LLC NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20191231 70199-010_27b51a77-a690-42ca-ad60-6f657202a198 70199-010 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B sulfates, Bacitracin zinc Neomycin and Polymyxin B sulfates, Bacitracin zinc OINTMENT OPHTHALMIC 20170407 NDA NDA050417 Casper Pharma LLC NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 10000; 400 mg/g; [USP'U]/g; [USP'U]/g Decreased Cell Wall Synthesis & Repair [PE],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 70199-013_d3a4d928-d6a6-4e3f-a26d-e10211f33180 70199-013 HUMAN PRESCRIPTION DRUG TRIGLIDE FENOFIBRATE TABLET ORAL 20170201 NDA NDA021350 Casper Pharma LLC FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 70201-001_23bbacc3-c6e0-500c-e054-00144ff88e88 70201-001 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50% Isopropyl Alcohol LIQUID TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part333A North & South Wholesalers LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 70201-002_23b91af3-afe3-53dd-e054-00144ff8d46c 70201-002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol 50% with Wintergreen and Glycerin Isopropyl Alcohol LIQUID TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part333A North & South Wholesalers LLC ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 70201-003_241fd9f0-9016-4299-e054-00144ff8d46c 70201-003 HUMAN OTC DRUG Ice Cold Analgesic MENTHOL,CAMPHOR GEL TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part348 North & South Wholesalers LLC MENTHOL; CAMPHOR (SYNTHETIC) 1; .5 g/100g; g/100g N 20181231 70201-004_23b91af3-afd1-53dd-e054-00144ff8d46c 70201-004 HUMAN OTC DRUG Chest Rub Vaporizing Menthol and Camphor and Eucalyptus Oil GEL TOPICAL 20151103 OTC MONOGRAPH NOT FINAL part348 North & South Wholesalers LLC CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 4.7; 1; 1 g/100g; g/100g; g/100g N 20181231 70202-0001_2ad79c23-a2d0-50c8-e054-00144ff8d46c 70202-0001 HUMAN OTC DRUG Abelia collagen amplifying mask DIPROPYLENE GLYCOL LIQUID TOPICAL 20160128 UNAPPROVED DRUG OTHER TERRASUN CO., LTD. DIPROPYLENE GLYCOL 1 g/100g N 20181231 70202-0002_2a73f871-728f-312c-e054-00144ff88e88 70202-0002 HUMAN OTC DRUG Abelia green tea energy mask DIPROPYLENE GLYCOL LIQUID TOPICAL 20160128 UNAPPROVED DRUG OTHER TERRASUN CO., LTD. DIPROPYLENE GLYCOL 1 g/100g N 20181231 70202-0003_2a7620d3-0f5a-1740-e054-00144ff8d46c 70202-0003 HUMAN OTC DRUG Abelia royal jelly nutrition mask DIPROPYLENE GLYCOL LIQUID TOPICAL 20160128 UNAPPROVED DRUG OTHER TERRASUN CO., LTD. DIPROPYLENE GLYCOL 1 g/100g N 20181231 70202-0004_2ad79c23-a2d2-50c8-e054-00144ff8d46c 70202-0004 HUMAN OTC DRUG Abelia aloe vera moisturizing mask DIPROPYLENE GLYCOL LIQUID TOPICAL 20160128 UNAPPROVED DRUG OTHER TERRASUN CO., LTD. DIPROPYLENE GLYCOL 1 g/100g N 20181231 70202-0005_2a7620d3-0f74-1740-e054-00144ff8d46c 70202-0005 HUMAN OTC DRUG Abelia cucumber soothing mask DIPROPYLENE GLYCOL LIQUID TOPICAL 20160128 UNAPPROVED DRUG OTHER TERRASUN CO., LTD. DIPROPYLENE GLYCOL 1 g/100g N 20181231 70202-0006_2a7620d3-0f82-1740-e054-00144ff8d46c 70202-0006 HUMAN OTC DRUG Abelia pomegranate bounce up mask DIPROPYLENE GLYCOL LIQUID TOPICAL 20160128 UNAPPROVED DRUG OTHER TERRASUN CO., LTD. DIPROPYLENE GLYCOL 1 g/100g N 20181231 70202-0007_2a7620d3-0f90-1740-e054-00144ff8d46c 70202-0007 HUMAN OTC DRUG Abelia lemon brightening mask DIPROPYLENE GLYCOL LIQUID TOPICAL 20160128 UNAPPROVED DRUG OTHER TERRASUN CO., LTD. DIPROPYLENE GLYCOL 1 g/100g N 20181231 70202-0008_2a76f959-97a8-00cc-e054-00144ff88e88 70202-0008 HUMAN OTC DRUG Abelia seaweed refining mask DIPROPYLENE GLYCOL LIQUID TOPICAL 20160128 UNAPPROVED DRUG OTHER TERRASUN CO., LTD. DIPROPYLENE GLYCOL 1 g/100g N 20181231 70202-0009_2a73eb51-8f65-2e8c-e054-00144ff88e88 70202-0009 HUMAN OTC DRUG NOBLESSE MANZ GROOMING SO CLEAN CARE ALLANTOIN LIQUID TOPICAL 20160129 OTC MONOGRAPH FINAL part347 TERRASUN CO., LTD. ALLANTOIN .08 g/100mL N 20181231 70202-0010_2a7380c3-f017-6fdd-e054-00144ff88e88 70202-0010 HUMAN OTC DRUG NOBLESSE HOMME REFRESH TONER GLYCERIN LIQUID TOPICAL 20160129 OTC MONOGRAPH FINAL part347 TERRASUN CO., LTD. GLYCERIN 10 g/100mL N 20181231 70202-0011_2a73f871-726e-312c-e054-00144ff88e88 70202-0011 HUMAN OTC DRUG NOBLESSE HOMME REFRESH GLYCERIN EMULSION TOPICAL 20160129 OTC MONOGRAPH FINAL part347 TERRASUN CO., LTD. GLYCERIN .8 g/100mL N 20181231 70204-100_60de803c-cf82-c7d7-e053-2a91aa0a1345 70204-100 HUMAN OTC DRUG Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160524 OTC MONOGRAPH NOT FINAL part333E Hit Promotional Products ALCOHOL 620 mg/mL N 20181231 70205-544_2aa02f68-91d9-4e13-ae9b-7075132f5c91 70205-544 HUMAN OTC DRUG Gold Antiseptic CHLOROXYLENOL SOAP TOPICAL 20151012 OTC MONOGRAPH NOT FINAL part333E Stigler Supply CHLOROXYLENOL 3 mg/mL N 20181231 70209-001_13283ebf-cebf-4d45-8dc3-5ebc227bed67 70209-001 HUMAN OTC DRUG SKEDERM ULTIMATE EYE NIACINAMIDE CREAM TOPICAL 20180126 UNAPPROVED DRUG OTHER Skederm Inc. NIACINAMIDE .3 mg/15mL N 20191231 70209-003_8a20900e-8248-4724-9d19-570b55276c9c 70209-003 HUMAN OTC DRUG SKEDERM VITAMIN C X30 POWER SERUM DIMETHICONE CREAM TOPICAL 20180126 UNAPPROVED DRUG OTHER Skederm Inc. GLYCERIN 1.33 mg/30mL N 20191231 70209-004_b8a40759-affe-4501-a43c-0b142858cd0a 70209-004 HUMAN OTC DRUG SKEDERM LIFTING GLYCERIN PATCH TOPICAL 20180130 OTC MONOGRAPH FINAL part347 Skederm Inc. GLYCERIN 2.1 g/7g N 20191231 70209-005_ed7d6148-e344-4873-bc12-bcfe0e675008 70209-005 HUMAN OTC DRUG SKEDERM SMART NECK DIMETHICONE CREAM TOPICAL 20170629 OTC MONOGRAPH FINAL part347 Skederm Inc. DIMETHICONE 1.04 mg/50mL N 20181231 70211-702_23939910-3d5a-5ffb-e054-00144ff8d46c 70211-702 HUMAN OTC DRUG COATS ALOE ALLANTOIN LOTION TOPICAL 20151102 OTC MONOGRAPH FINAL part347 TYCHASIS CORPORATION ALLANTOIN .5 g/100mL N 20181231 70211-703_2390d20f-58c5-084e-e054-00144ff88e88 70211-703 HUMAN OTC DRUG COATS ALOE ALLANTOIN CREAM TOPICAL 20151102 OTC MONOGRAPH FINAL part347 TYCHASIS CORPORATION ALLANTOIN .5 mg/100g N 20181231 70211-704_2392751d-4026-3a1d-e054-00144ff88e88 70211-704 HUMAN OTC DRUG COATS ALOE ANALGESIC METHYL SALICYLATE LOTION TOPICAL 20151102 OTC MONOGRAPH NOT FINAL part348 TYCHASIS CORPORATION METHYL SALICYLATE 10 g/100mL N 20181231 70211-705_2393ef7e-c7db-07b4-e054-00144ff88e88 70211-705 HUMAN OTC DRUG COATS ALOE ALLANTOIN JELLY TOPICAL 20151102 OTC MONOGRAPH FINAL part347 TYCHASIS CORPORATION ALLANTOIN .5 g/100mL N 20181231 70218-010_df713ea8-4ef3-4335-80e9-56b3fba9afec 70218-010 HUMAN OTC DRUG SRB 3 Lighting White Nutri Glycerin CREAM TOPICAL 20151001 UNAPPROVED DRUG OTHER CASINBIO CO., LTD. GLYCERIN 5.6 g/50g E 20171231 70218-020_9d328a75-d0ba-420f-960d-db94c3ce05aa 70218-020 HUMAN OTC DRUG SRB 3 Lighting White BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 CASINBIO CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 3.8; 2.01 g/35g; g/35g E 20171231 70218-030_92231cb6-d5fa-496b-be4c-b1ae462906d5 70218-030 HUMAN OTC DRUG SRB 3 Lighting White Sun OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part352 CASINBIO CO., LTD. OCTINOXATE; OCTISALATE; AVOBENZONE 3.75; 2.5; 1.5 mg/50mL; mg/50mL; mg/50mL E 20171231 70220-010_1a35326d-85a1-42d9-a28f-43d3108c06ab 70220-010 HUMAN OTC DRUG Inner Beauty Clean WITCH HAZEL GEL VAGINAL 20151101 OTC MONOGRAPH FINAL part347 AMINI WITCH HAZEL .68 mg/80mL E 20171231 70220-020_a53ea205-e715-4613-b0f1-ce91b9c67929 70220-020 HUMAN OTC DRUG Inner Beauty Cleansing Tissue GLYCERIN SOLUTION VAGINAL 20151101 UNAPPROVED DRUG OTHER AMINI GLYCERIN 6 g/100g E 20171231 70221-010_89ed6206-4735-4b55-b95f-847c2d1ca399 70221-010 HUMAN OTC DRUG Elikin Aqua MaskPack Glycerin PATCH TOPICAL 20151001 UNAPPROVED DRUG OTHER WOORITECH CO., LTD GLYCERIN 1.75 mg/101 E 20171231 70221-020_995e72be-ae27-4098-9169-bda522798cf3 70221-020 HUMAN OTC DRUG Elikin Anti Wrinkle MaskPack Glycerin PATCH TOPICAL 20151001 UNAPPROVED DRUG OTHER WOORITECH CO., LTD GLYCERIN 1.75 mg/101 E 20171231 70221-030_d6c07729-917f-4a62-8d92-b7c14c745df6 70221-030 HUMAN OTC DRUG Elikin Collagen MaskPack Glycerin PATCH TOPICAL 20151001 UNAPPROVED DRUG OTHER WOORITECH CO., LTD GLYCERIN 1.75 mg/101 E 20171231 70221-040_e7755bf2-15a2-40f5-bf51-b9adc939fbe8 70221-040 HUMAN OTC DRUG Elikin Collagen MaskPack Glycerin PATCH TOPICAL 20151001 UNAPPROVED DRUG OTHER WOORITECH CO., LTD GLYCERIN 1.75 mg/101 E 20171231 70221-050_4eaa6b57-80a1-436f-8088-f37f8cccb1f1 70221-050 HUMAN OTC DRUG Elikin Whitening MaskPack Glycerin PATCH TOPICAL 20151001 UNAPPROVED DRUG OTHER WOORITECH CO., LTD GLYCERIN 1.75 mg/101 E 20171231 70223-001_24a80a2a-7953-004d-e054-00144ff8d46c 70223-001 HUMAN OTC DRUG Elroselabs Conzerol CREAM TOPICAL 20151210 UNAPPROVED HOMEOPATHIC Elroselabs Inc. POTASSIUM CHLORIDE; SULFUR; POTASSIUM BROMIDE; SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE 6; 3; 6; 6; 6; 6 [hp_X]/30g; [hp_X]/30g; [hp_X]/30g; [hp_C]/30g; [hp_C]/30g; [hp_X]/30g N 20181231 70223-001_9032434c-247f-4875-bc69-44a7cde91528 70223-001 HUMAN OTC DRUG Elrose Labs Conzerol CREAM TOPICAL 20151116 UNAPPROVED HOMEOPATHIC Elroselabs Inc. SILICON DIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM BROMIDE 6; 6; 6; 6; 6 mg/28.3mg; mg/28.3mg; [hp_X]/28.3mg; mg/28.3mg; mg/28.3mg N 20181231 70224-010_560b4d3b-0ac0-4f3c-89be-bb3be9cd7902 70224-010 HUMAN OTC DRUG Li om FERMENTATION FORM ELASTIC CARE SECRET SERUM Glycerin SOLUTION TOPICAL 20151001 UNAPPROVED DRUG OTHER KOREAMEDICOS GLYCERIN 1.94 mg/60mL E 20171231 70227-001_2575f3b6-ebca-1395-e054-00144ff8d46c 70227-001 HUMAN OTC DRUG Super CC Color Correction Care Primer Stick SPF 30 Octinoxate, Octocrylene, Oxybenzone,Titanium Dioxide, Zinc Oxide STICK TOPICAL 20151123 OTC MONOGRAPH FINAL part352 Grand Metro Cosmetics Company OXYBENZONE; ZINC OXIDE; OCTOCRYLENE; OCTINOXATE; TITANIUM DIOXIDE 5.1; 4; 4.2; 5.6; 5.2 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 70230-1001_31983126-5db2-0162-e054-00144ff88e88 70230-1001 HUMAN OTC DRUG Medi All 4 Cleanser (NIACINAMIDE) NIACINAMIDE LIQUID TOPICAL 20150401 UNAPPROVED DRUG OTHER Katecosmetics. Co., Ltd, (KISD) PANTHENOL; NIACINAMIDE .05; .2 mg/100mL; mg/100mL E 20171231 70233-001_164aaaa7-c185-452a-b266-b73ec20b5aa1 70233-001 HUMAN OTC DRUG Infant Diaper Cream Anne Geddes Zinc Oxide CREAM TOPICAL 20150710 OTC MONOGRAPH FINAL part346 Fleet Laboratories LTD ZINC OXIDE 10 g/100g E 20171231 70233-002_ae1ef62d-9201-4ddc-a1f3-4b5fb9b1407f 70233-002 HUMAN OTC DRUG Anne Geddes Infant Anti-Gas Drops Simethicone LIQUID ORAL 20150922 OTC MONOGRAPH FINAL part332 Fleet Laboratories LTD DIMETHICONE 21 mg/100mL E 20171231 70233-003_a620a134-fea6-4e79-a48c-875e656af9b4 70233-003 HUMAN OTC DRUG Infant Nasal Anne Geddes Sodium Chloride LIQUID NASAL 20150713 OTC MONOGRAPH FINAL part349 FLEET LABORATORIES LTD SODIUM CHLORIDE .65 g/100mL E 20171231 70233-004_59a818fa-5c09-45ee-919a-afcd4d017764 70233-004 HUMAN OTC DRUG Premjact Male Desensitizer Pound International Lidocaine SPRAY, METERED TOPICAL 20130509 OTC MONOGRAPH NOT FINAL part348 FLEET LABORATORIES LTD LIDOCAINE 9.6 g/100mL N 20181231 70233-005_b133ccce-7c20-40ba-ba1b-c98a2e410330 70233-005 HUMAN OTC DRUG Male Genital Desensitizer Stud 100 Lidocane SPRAY, METERED TOPICAL 20130313 OTC MONOGRAPH FINAL part348 FLEET LABORATORIES LTD LIDOCAINE 9.6 mg/100mL N 20181231 70236-100_629e7692-3331-066e-e053-2a91aa0a1d07 70236-100 HUMAN OTC DRUG C-Patch Menthol, Camphor PATCH TOPICAL 20180112 OTC MONOGRAPH NOT FINAL part348 NeoBiotech Global Corporation CAMPHOR (SYNTHETIC); MENTHOL .045; .225 g/9g; g/9g N 20191231 70236-101_62b1ccdf-e788-cee5-e053-2991aa0adc43 70236-101 HUMAN OTC DRUG C-Patch Grande Menthol, Camphor PATCH TOPICAL 20180113 OTC MONOGRAPH NOT FINAL part348 NeoBiotech Global Corporation MENTHOL; CAMPHOR (SYNTHETIC) .7; .14 g/28g; g/28g N 20191231 70238-702_48a814e7-bfe5-5437-e054-00144ff88e88 70238-702 HUMAN OTC DRUG PEAK Sunscreen 100 Natural SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20151110 OTC MONOGRAPH NOT FINAL part352 Peak Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 70239-703_47f5441d-e6f4-0485-e054-00144ff8d46c 70239-703 HUMAN OTC DRUG Sparkle Screen Broad Spectrum 30 Glittering Gold Kiwi-Pear Scented TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20151110 OTC MONOGRAPH NOT FINAL part352 GlitterTots LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/g; mg/g N 20181231 70239-705_48078234-d8fd-546e-e054-00144ff8d46c 70239-705 HUMAN OTC DRUG Super Sparkle Screen Broad Spectrum 30 Sunkissed Gold Glitter Tangerine Scented OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20151110 OTC MONOGRAPH NOT FINAL part352 Glitter Tots, LLC OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 30; 30 mg/g; mg/g; mg/g N 20181231 70239-706_4807a2bb-48aa-0325-e054-00144ff88e88 70239-706 HUMAN OTC DRUG Super Sparkle Screen Broad Spectrum 30 Sunkissed Pink Glitter Strawberry Scented OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20151110 OTC MONOGRAPH NOT FINAL part352 Glitter Tots, LLC OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 30; 30 mg/g; mg/g; mg/g N 20181231 70242-100_7d252cf1-7163-46ee-a456-b7460e82c153 70242-100 HUMAN OTC DRUG Broncomar Expectorant SF Guaifenesin LIQUID ORAL 20011001 OTC MONOGRAPH FINAL part341 Dannso Corp./d.b.a. Essential Products GUAIFENESIN 100 mg/5mL E 20171231 70242-101_7d4a968f-85fe-4681-992a-f5136767d753 70242-101 HUMAN OTC DRUG Broncomar DM Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20011001 OTC MONOGRAPH FINAL part341 Dannso Corp./d.b.a. Essential Products DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 70242-102_80680d23-1f67-44f4-8372-b790847375e4 70242-102 HUMAN OTC DRUG Broncomar EXPECTORANT Acetaminofen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl LIQUID ORAL 20011001 OTC MONOGRAPH FINAL part341 Dannso Corp./d.b.a. Essential Products ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 250; 13.33; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL E 20171231 70242-103_9af2579f-9e78-47bb-84f0-a9fef9227fe9 70242-103 HUMAN OTC DRUG Broncomar Maximun Cough Relief Dextromethorphan HBr, Guaifenesin LIQUID ORAL 20011001 OTC MONOGRAPH FINAL part341 Dannso Corp./d.b.a. Essential Products DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 30; 200 mg/10mL; mg/10mL N 20181231 70242-104_fdad33d5-9435-4117-a52b-bf6ed67894af 70242-104 HUMAN OTC DRUG FUNGISOLVE TOLNAFTATE ANTIFUNGAL TOLNAFTATE SPRAY TOPICAL 20110316 OTC MONOGRAPH FINAL part333C Dannso Corp./d.b.a. Essential Products TOLNAFTATE 10 mg/mL E 20171231 70242-106_b87d7401-f831-4e29-8207-988ed17061c6 70242-106 HUMAN OTC DRUG FUNGISOLVE TOLNAFTATE ANTIFUNGAL TOLNAFTATE LIQUID TOPICAL 20110316 OTC MONOGRAPH FINAL part333C Dannso Corp./d.b.a. Essential Products TOLNAFTATE 10 mg/mL E 20171231 70242-107_b9b55d82-4364-4828-97e6-ba72953fa845 70242-107 HUMAN OTC DRUG FUNGISOLVE TOLNAFTATE ANTIFUNGAL TOLNAFTATE CREAM TOPICAL 20110316 OTC MONOGRAPH FINAL part333C Dannso Corp./d.b.a. Essential Products TOLNAFTATE 1 g/100g E 20171231 70242-108_d4144fcc-20aa-446d-ad87-65104294be02 70242-108 HUMAN OTC DRUG FUNGISOLVE TOLNAFTATE ANTIFUNGAL TOLNAFTATE CREAM TOPICAL 20110316 OTC MONOGRAPH FINAL part333C Dannso Corp./d.b.a. Essential Products TOLNAFTATE 1 g/100g E 20171231 70242-109_d17a1371-3259-4aa6-974b-76cbae816111 70242-109 HUMAN OTC DRUG Iodine Tincture White Iodine tincture SOLUTION/ DROPS TOPICAL 20150808 OTC MONOGRAPH NOT FINAL part333A Dannso Corp./d.b.a. Essential Products IODINE 20 mg/mL E 20171231 70242-110_9cf89584-bb8e-4cd6-8c64-288912836f5b 70242-110 HUMAN OTC DRUG Iodine Tincture Rojo Iodine tincture SOLUTION/ DROPS TOPICAL 20150808 OTC MONOGRAPH NOT FINAL part333A Dannso Corp./d.b.a. Essential Products IODINE 20 mg/mL E 20171231 70242-125_d1735d0b-8317-490d-8eb5-173461966008 70242-125 HUMAN OTC DRUG Veneno de Abeja Aceite De Vibora Brand Methyl Salicylate OINTMENT TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part346 Dannso Corp./d.b.a. Essential Products METHYL SALICYLATE 15.75 g/150g E 20171231 70242-127_ef753092-74fa-48b6-93e1-e3c772f87211 70242-127 HUMAN OTC DRUG Miel Rosada SODIUM BORATE, GLYCERIN SOLUTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part356 Dannso Corp./d.b.a. Essential Products SODIUM BORATE; GLYCERIN .1; .4 mg/mL; mg/mL E 20171231 70242-128_612d8092-7f64-463f-9d87-c47a12c343c0 70242-128 HUMAN OTC DRUG Tintuta de Mentiolate/Menthiolate Tincture Benzalkonium Chloride SOLUTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Dannso Corp./d.b.a. Essential Products BENZALKONIUM CHLORIDE .13 g/mL E 20171231 70242-129_0d8886b3-f624-4a7a-842a-561aeec71b65 70242-129 HUMAN OTC DRUG Tintura de Arnica Isopropyl Alcohol and Arnica Extract SOLUTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Dannso Corp./d.b.a. Essential Products ISOPROPYL ALCOHOL .13 g/mL E 20171231 70242-130_d8b25ab0-8a7f-4405-a949-d09a4a138acf 70242-130 HUMAN OTC DRUG Mercurochrome Benzalkonium Chloride SOLUTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A Dannso Corp./d.b.a. Essential Products BENZALKONIUM CHLORIDE .13 g/mL E 20171231 70242-131_17197886-8f32-41a8-afa9-6f2c53a83bd1 70242-131 HUMAN OTC DRUG SODIUM BICARBONATE ANTACID SODIUM BICARBONATE POWDER ORAL 20130925 OTC MONOGRAPH FINAL part331 Dannso Corp./d.b.a. Essential Products SODIUM BICARBONATE 2.6 g/2.6g E 20171231 70242-134_fd610cf1-30a4-450f-b60f-b34e3e011ab2 70242-134 HUMAN OTC DRUG Parasitexx PYRANTEL PAMOATE SUSPENSION ORAL 20170501 OTC MONOGRAPH FINAL part357B Dannso Corp./d.b.a. Essential Products PYRANTEL PAMOATE 144 mg/mL N 20181231 70248-708_480818b5-84bd-4386-e054-00144ff8d46c 70248-708 HUMAN OTC DRUG Genorthix Pain Relieving Roll On METHYL SALICYLATE, MENTHOL, CAPSAICIN SOLUTION TOPICAL 20151111 OTC MONOGRAPH NOT FINAL part348 Genorthix CAPSAICIN; METHYL SALICYLATE; MENTHOL .25; 100; 14 mg/g; mg/g; mg/g N 20181231 70249-707_47f4f989-faf0-6576-e054-00144ff8d46c 70249-707 HUMAN OTC DRUG Daily Defense Antioxidant Day Broad Spectrum SPF 30 OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20151111 OTC MONOGRAPH NOT FINAL part352 Skin Actives Scientific, LLC OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 40; 25 mg/mL; mg/mL; mg/mL N 20181231 70252-348_0cc5b8d5-3b02-48b8-96ce-21abc239c01d 70252-348 HUMAN OTC DRUG Divercalm Arsenicum Alb, Nat Phos, Nux Vom, Veratrum Alb, Bacillus No. 7, Gaertner Bach, Intestinum Crassum, Sycotic Co LIQUID ORAL 20151112 UNAPPROVED HOMEOPATHIC Paula Tipton-Healy ARSENIC TRIOXIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; VERATRUM ALBUM ROOT; ENTEROBACTER CLOACAE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS; SUS SCROFA COLON; ENTEROCOCCUS FAECALIS 6; 6; 9; 9; 18; 15; 15; 18 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 70253-016_20f0c950-4d46-41e3-be22-e71b6481ad94 70253-016 HUMAN OTC DRUG Our Family Triple Antibiotic Bacitracin zinc, Neomycin sulfate, and Polymyxin B sulfate OINTMENT TOPICAL 19951214 OTC MONOGRAPH FINAL part333B Nash-Finch Company BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 70253-019_1f5b0719-4346-4dcf-9748-ba4560bddb9a 70253-019 HUMAN OTC DRUG Heartburn Relief 24 hour Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20130327 ANDA ANDA202727 OUR FAMILY (Nash Finch Company) LANSOPRAZOLE 15 mg/1 N 20181231 70253-022_db1c765e-4b2e-454c-8b3c-0705db682bb4 70253-022 HUMAN OTC DRUG Our Family Athletes Foot Clotrimazole CREAM TOPICAL 19930831 OTC MONOGRAPH FINAL part333C Nash Finch Company CLOTRIMAZOLE 10 mg/g N 20181231 70253-059_55c7ef73-d31e-46df-9130-3fafdbe4cd9e 70253-059 HUMAN OTC DRUG Our Family Hydrocortisone with Aloe Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Nash-Finch Company HYDROCORTISONE 1 g/100g N 20181231 70253-069_27080afc-4411-48b0-abaf-88d3c1c2f7e7 70253-069 HUMAN OTC DRUG Petroleum Skin Protectant White Petrolatum JELLY TOPICAL 19900115 OTC MONOGRAPH FINAL part347 Nash Finch Company PETROLATUM 1 g/g N 20181231 70253-104_f350b177-e7df-4874-b880-9a7c2b41bfd5 70253-104 HUMAN OTC DRUG Pain Reliever Acetaminophen TABLET ORAL 19900713 20190126 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN 325 mg/1 E 20171231 70253-106_8266106e-e387-40b2-8dc0-251a3335b54f 70253-106 HUMAN OTC DRUG Our Family Childrens Cetirizine Cetirizine Hydrochloride SOLUTION ORAL 20110520 ANDA ANDA201546 Nash Finch Company CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 70253-128_5af0651f-ab83-4792-b462-4793f4d0c643 70253-128 HUMAN OTC DRUG Famotidine Famotidine TABLET ORAL 20131015 ANDA ANDA077146 OUR FAMILY (Nash Finch Company) FAMOTIDINE 10 mg/1 N 20181231 70253-129_cfb58d0b-4e30-40d2-b808-cefb41f96af8 70253-129 HUMAN OTC DRUG All Day Allergy Relief 24 Hour Cetirizine HCl TABLET ORAL 20130315 ANDA ANDA078780 OUR FAMILY (NASH FINCH COMPANY) CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 70253-153_b02e567e-1cba-4c16-a1b3-7dba95881bd8 70253-153 HUMAN OTC DRUG Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 19980605 OTC MONOGRAPH FINAL part358 Nash Finch Company PYRITHIONE ZINC 1 kg/100kg N 20181231 70253-159_d256425b-b697-40ce-bf9d-e0b6e21d6e00 70253-159 HUMAN OTC DRUG Headache Relief Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 19921117 20190126 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 E 20171231 70253-175_d3debf7f-1246-4d23-88fe-9fca1765e0e2 70253-175 HUMAN OTC DRUG Pain Reliever Acetaminophen TABLET ORAL 19930402 20180402 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN 500 mg/1 E 20171231 70253-190_dbbe0ffa-c216-4383-bd5f-ae1cf833cf98 70253-190 HUMAN OTC DRUG Allergy Complete Relief Diphenhydramine HCl CAPSULE ORAL 19900315 20180402 OTC MONOGRAPH FINAL part336 NASH-FINCH COMPANY DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 70253-199_19a6fe87-33b9-4815-9ca7-98e251dc9b7a 70253-199 HUMAN OTC DRUG Ibuprofen IBUPROFEN CAPSULE, LIQUID FILLED ORAL 20130430 ANDA ANDA078682 OUR FAMILY (Nash Finch Company) IBUPROFEN 200 mg/1 N 20181231 70253-225_e91cc306-fb7b-4d45-9512-3b11cc4bf6b7 70253-225 HUMAN OTC DRUG Nighttime Sleep Aid Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED ORAL 20131130 OTC MONOGRAPH FINAL part338 OUR FAMILY (Nash Finch Company) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70253-226_df5d4555-1065-42e4-b4ff-b3dde5312451 70253-226 HUMAN OTC DRUG Stay Awake Caffeine TABLET ORAL 19921121 20180402 OTC MONOGRAPH FINAL part340 NASH-FINCH COMPANY CAFFEINE 200 mg/1 E 20171231 70253-229_fcd5ab97-c87c-4e21-9f0e-1f08c1745670 70253-229 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl TABLET, COATED ORAL 20130331 OTC MONOGRAPH FINAL part338 OUR FAMILY (Nash Finch Company) ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 70253-233_c6330b6e-5f87-4ac4-bcca-d933b19200c2 70253-233 HUMAN OTC DRUG Mucus Relief Cold, Flu and Sore Throat Maximum Strength Mucinex Fast Max Cold, Flu and Sore Throat Maximum Strength LIQUID ORAL 20131121 20181111 OTC MONOGRAPH FINAL part341 Nash Finch Company GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 400; 20; 650; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 70253-235_b7f917a5-3583-463a-857a-a272f30324ec 70253-235 HUMAN OTC DRUG Pain Reliever PM Acetaminophen and Diphenhydramine HCl TABLET, FILM COATED ORAL 19940515 20180713 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 70253-236_4e224d76-dbbe-4599-9edf-2f7c1974d22e 70253-236 HUMAN OTC DRUG Nighttime Sleep Aid Maximum Strength Diphenhydramine HCl CAPSULE ORAL 20140201 OTC MONOGRAPH FINAL part341 OUR FAMILY (Nash Finch Company) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 70253-242_516e2677-54cf-4699-ba9d-5ad9b74a2230 70253-242 HUMAN OTC DRUG Gas Relief Extra Strength SIMETHICONE CAPSULE, LIQUID FILLED ORAL 20130930 OTC MONOGRAPH FINAL part347 OUR FAMILY (Nash Finch Company) DIMETHICONE 125 mg/1 N 20181231 70253-291_dbc5e779-f7b5-4da2-bed7-0a8002ac4d60 70253-291 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 19880524 20180909 ANDA ANDA075010 NASH-FINCH COMPANY IBUPROFEN 200 mg/1 E 20171231 70253-292_2a5d9752-cad6-4ee8-9908-195d1bc7d82c 70253-292 HUMAN OTC DRUG Ibuprofen Ibuprofen CAPSULE, COATED ORAL 19880524 20180402 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY IBUPROFEN 200 mg/1 E 20171231 70253-299_eb4bf870-c4ca-4af2-b1b2-8d708374f329 70253-299 HUMAN OTC DRUG Allergy Complete Relief Diphenhydramine HCl CAPSULE, LIQUID FILLED ORAL 20010913 20180727 OTC MONOGRAPH FINAL part336 NASH-FINCH COMPANY DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 70253-326_9b444816-513a-4084-92ee-4e58cfd178cc 70253-326 HUMAN OTC DRUG Womens Laxative Bisacodyl TABLET, COATED ORAL 20050212 20180402 OTC MONOGRAPH NOT FINAL part334 NASH-FINCH COMPANY BISACODYL 5 mg/1 E 20171231 70253-327_aa329d94-d60c-4a9b-aebd-d707ba6bedb1 70253-327 HUMAN OTC DRUG Gentle Laxative Bisacodyl TABLET ORAL 20020325 20180402 OTC MONOGRAPH NOT FINAL part334 NASH-FINCH COMPANY BISACODYL 5 mg/1 E 20171231 70253-329_a2bd344e-e5af-4a2d-8144-0f297c4463d6 70253-329 HUMAN OTC DRUG Allergy Complete Relief Diphenhydramine HCl TABLET ORAL 19900302 20180402 OTC MONOGRAPH FINAL part341 NASH-FINCH COMPANY DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 70253-348_7bc06a63-4b47-4fbd-8507-ee63e859d930 70253-348 HUMAN OTC DRUG Maximum Strength Laxative Sennosides TABLET, COATED ORAL 20030104 20180402 OTC MONOGRAPH NOT FINAL part334 NASH-FINCH COMPANY SENNOSIDES 25 mg/1 E 20171231 70253-367_63896e36-37de-4257-8007-2f57f36610c7 70253-367 HUMAN OTC DRUG Rest Simply Diphenhydramine HCl TABLET, FILM COATED ORAL 20000610 20180402 OTC MONOGRAPH FINAL part338 NASH-FINCH COMPANY DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 70253-375_c468be11-5571-421e-b033-84abe984e23c 70253-375 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl CAPSULE ORAL 20050503 20180402 ANDA ANDA076497 NASH-FINCH COMPANY LOPERAMIDE HYDROCHLORIDE 2 mg/1 E 20171231 70253-392_e964bc7e-c786-454a-9523-74b3c770f4dd 70253-392 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20020330 20180402 ANDA ANDA075139 NASH-FINCH COMPANY IBUPROFEN 200 mg/1 E 20171231 70253-397_64f59d3c-35b7-457d-8d3a-d4aaf681b320 70253-397 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET, CHEWABLE ORAL 20010904 20180402 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ASPIRIN 81 mg/1 E 20171231 70253-403_539f312e-be45-47fb-bcff-58737b9f7303 70253-403 HUMAN OTC DRUG Motion Sickness Relief Meclizine HCl TABLET ORAL 20020624 20180402 OTC MONOGRAPH FINAL part336 NASH-FINCH COMPANY MECLIZINE HYDROCHLORIDE 25 mg/1 E 20171231 70253-453_cd6ec58d-c089-4ae7-a8da-3f64c0bba2d7 70253-453 HUMAN OTC DRUG Suphedrine PE Phenylephrine HCl TABLET, FILM COATED ORAL 20041206 20180402 OTC MONOGRAPH FINAL part341 NASH-FINCH COMPANY PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 E 20171231 70253-455_f144c75d-a84d-4d75-9740-b5f6019d1c08 70253-455 HUMAN OTC DRUG Allergy Multi-Symptom Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET ORAL 20050628 20180713 OTC MONOGRAPH FINAL part341 NASH-FINCH COMPANY ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 2; 5 mg/1; mg/1; mg/1 E 20171231 70253-470_6bda14af-c402-4114-a7af-12e3a917a2a8 70253-470 HUMAN OTC DRUG Day Time Cold/Flu Relief ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED ORAL 20130531 OTC MONOGRAPH FINAL part341 OUR FAMILY (Nash Finch Company) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 70253-519_df364f37-8878-4dea-8372-9b7c7204741f 70253-519 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen CAPSULE, LIQUID FILLED ORAL 20040510 20180402 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN 500 mg/1 E 20171231 70253-527_ad506102-3ef3-45da-af60-a1a36d782783 70253-527 HUMAN OTC DRUG Sinus Congestion and Pain Severe Acetaminophen, Guaifenesin and Phenylephrine HCl TABLET, COATED ORAL 20050806 20180402 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 325; 200; 5 mg/1; mg/1; mg/1 E 20171231 70253-531_ccf3711b-6085-4340-a47a-fa1183d1b0fb 70253-531 HUMAN OTC DRUG Extra Strength Pain Reliever Acetaminophen TABLET ORAL 20051211 20180713 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN 500 mg/1 E 20171231 70253-532_7196fe97-fca0-42b4-ad6e-8c9b30264b8a 70253-532 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET, FILM COATED ORAL 20051222 20180402 OTC MONOGRAPH FINAL part341 NASH-FINCH COMPANY GUAIFENESIN 400 mg/1 E 20171231 70253-533_4b7d0aa6-f0f2-49df-8bfe-3fa0479b5482 70253-533 HUMAN OTC DRUG Mucus Relief DM Dextromethorphan HBr and Guiafenesin TABLET, FILM COATED ORAL 20051231 20180402 OTC MONOGRAPH FINAL part341 NASH-FINCH COMPANY DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 E 20171231 70253-556_59300b3a-f476-4d7a-9406-b3272d7dd918 70253-556 HUMAN OTC DRUG Pain Reliever PM Extra Strength Acetaminophen, Diphenhydramine HCl CAPSULE ORAL 20071217 20180402 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 E 20171231 70253-558_e5955dad-e31e-4c00-a193-c8ab0abef7a4 70253-558 HUMAN OTC DRUG Sinus Congestion and Pain Daytime Acetaminophen and Phenylephrine HCl CAPSULE ORAL 20080317 20180402 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 E 20171231 70253-600_105217c2-26e5-4852-9d6c-890dfd67a554 70253-600 HUMAN OTC DRUG Enteric Coated Aspirin Aspirin TABLET ORAL 20080212 20180610 OTC MONOGRAPH NOT FINAL part343 NASH-FINCH COMPANY ASPIRIN 81 mg/1 E 20171231 70253-620_46539a4a-b112-4a52-abf6-6338b614f681 70253-620 HUMAN OTC DRUG Acid Reducer Ranitidine TABLET, FILM COATED ORAL 20130615 20180715 ANDA ANDA200536 NASH-FINCH COMPANY RANITIDINE HYDROCHLORIDE 150 mg/1 E 20171231 70257-560_3a37aef1-3786-4107-9437-47eb2ad1855d 70257-560 HUMAN PRESCRIPTION DRUG Lioresal (baclofen) baclofen INJECTION INTRATHECAL 20170705 NDA NDA020075 Saol Therapeutics Inc. BACLOFEN 10 mg/20mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 70257-561_3a37aef1-3786-4107-9437-47eb2ad1855d 70257-561 HUMAN PRESCRIPTION DRUG Lioresal (baclofen) baclofen INJECTION INTRATHECAL 20170705 NDA NDA020075 Saol Therapeutics Inc. BACLOFEN 10 mg/5mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 70257-562_3a37aef1-3786-4107-9437-47eb2ad1855d 70257-562 HUMAN PRESCRIPTION DRUG Lioresal (baclofen) baclofen INJECTION INTRATHECAL 20170705 NDA NDA020075 Saol Therapeutics Inc. BACLOFEN .05 mg/mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 70257-563_3a37aef1-3786-4107-9437-47eb2ad1855d 70257-563 HUMAN PRESCRIPTION DRUG Lioresal (baclofen) baclofen INJECTION INTRATHECAL 20170705 NDA NDA020075 Saol Therapeutics Inc. BACLOFEN 40 mg/20mL GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 70258-320_013cfb88-34ac-4187-814d-8f9c128352a6 70258-320 HUMAN OTC DRUG VASOPRO EPHEDRINE EPHEDRINE HYDROCHLORIDE, GUAIFENESIN TABLET ORAL 20151123 OTC MONOGRAPH FINAL part341 Optimal Research Inc EPHEDRINE HYDROCHLORIDE; GUAIFENESIN 25; 200 mg/1; mg/1 E 20171231 70260-426_ab8667c9-61ef-4c1b-ac09-3a05d07b78cd 70260-426 HUMAN PRESCRIPTION DRUG Pyrimethamine Leucovorin Pyrimethamine Leucovorin CAPSULE ORAL 20151125 UNAPPROVED DRUG OTHER South Coast Specialty Compounding, Inc. d/b/a Park Compounding PYRIMETHAMINE; LEUCOVORIN CALCIUM 25; 5 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70260-427_79f7c57b-5dbb-4751-8612-75460ab1b0ff 70260-427 HUMAN PRESCRIPTION DRUG Pyrimethamine Leucovorin Pyrimethamine Leucovorin CAPSULE ORAL 20151125 UNAPPROVED DRUG OTHER South Coast Specialty Compounding, Inc. d/b/a Park Compounding PYRIMETHAMINE; LEUCOVORIN CALCIUM 25; 10 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70260-428_1fff0272-4a60-47fe-a0d9-2985758345a6 70260-428 HUMAN PRESCRIPTION DRUG Pyrimethamine Leucovorin Pyrimethamine Leucovorin CAPSULE ORAL 20151125 UNAPPROVED DRUG OTHER South Coast Specialty Compounding, Inc. d/b/a Park Compounding PYRIMETHAMINE; LEUCOVORIN CALCIUM 50; 10 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70260-429_f7cc6b06-85dc-45b8-96a2-895495696805 70260-429 HUMAN PRESCRIPTION DRUG Pyrimethamine Leucovorin Pyrimethamine Leucovorin CAPSULE ORAL 20151125 UNAPPROVED DRUG OTHER South Coast Specialty Compounding, Inc. d/b/a Park Compounding PYRIMETHAMINE; LEUCOVORIN CALCIUM 50; 20 mg/1; min/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70260-430_dd697b04-0387-4387-a063-6b16b50d6931 70260-430 HUMAN PRESCRIPTION DRUG Pyrimethamine Leucovorin Pyrimethamine Leucovorin CAPSULE ORAL 20151125 UNAPPROVED DRUG OTHER South Coast Specialty Compounding, Inc. d/b/a Park Compounding PYRIMETHAMINE; LEUCOVORIN CALCIUM 12.5; 2.5 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70260-480_681ce3d4-2635-4586-abdd-14655ba7734d 70260-480 HUMAN PRESCRIPTION DRUG Pyrimethamine Leucovorin Pyrimethamine Leucovorin CAPSULE ORAL 20151130 UNAPPROVED DRUG OTHER South Coast Specialty Compounding, Inc. d/b/a Park Compounding PYRIMETHAMINE; LEUCOVORIN CALCIUM 50; 25 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70262-301_356994dc-ff3f-4c87-80f4-a6a493078fe3 70262-301 HUMAN OTC DRUG Aleve Caplets NAPROXEN SODIUM TABLET ORAL 20160315 NDA NDA020204 Your Safety Company NAPROXEN SODIUM 220 mg/1 E 20171231 70262-302_8408340e-4031-48c4-8ab3-2da800734105 70262-302 HUMAN OTC DRUG Bayer Genuine Aspirin Aspirin TABLET ORAL 20160315 OTC MONOGRAPH NOT FINAL part343 Your Safety Company ASPIRIN 325 mg/1 E 20171231 70262-303_f5b775ae-2ec7-46f4-a097-d2cf4c55ac2f 70262-303 HUMAN OTC DRUG Midol Complete ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE TABLET ORAL 20160315 OTC MONOGRAPH NOT FINAL part343 Your Safety Company ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 E 20171231 70262-304_9704c708-d2a5-4266-8ecf-d00949e3afc6 70262-304 HUMAN OTC DRUG Alka-Seltzer Original ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20160315 OTC MONOGRAPH NOT FINAL part343 Your Safety Company ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 325; 1916 mg/1; mg/1; mg/1 E 20171231 70263-333_5f32f291-0ef9-4b0e-bc46-5641fc67cfaf 70263-333 HUMAN PRESCRIPTION DRUG Oxiconazole Nitrate Cream 1% Oxiconazole Nitrate CREAM TOPICAL 20160801 ANDA ANDA205076 Welgo, Llc OXICONAZOLE NITRATE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 70263-555_6e678989-3074-403b-b54d-3abad82b134a 70263-555 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin CREAM TOPICAL 20180123 ANDA ANDA201587 Welgo, Llc MUPIROCIN CALCIUM 2 g/100g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20191231 70264-011_6bbdc84a-e5d3-406f-969e-4b8715858e19 70264-011 HUMAN OTC DRUG Aleve NAPROXEN SODIUM TABLET ORAL 20140226 NDA NDA020204 R J General Corporation NAPROXEN SODIUM 220 mg/1 E 20171231 70264-012_66f921c1-0386-467c-ad59-777e6c4c0b02 70264-012 HUMAN OTC DRUG MIDOL COMPLETE ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE TABLET ORAL 20140210 OTC MONOGRAPH NOT FINAL part343 R J General Corporation ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 E 20171231 70264-013_5344545f-8d3e-467b-a646-15cb55c275d7 70264-013 HUMAN OTC DRUG Bayer Genuine Aspirin Aspirin TABLET ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 R J General Corporation ASPIRIN 325 mg/1 E 20171231 70264-014_8b923633-fc82-4509-9494-fa5789372673 70264-014 HUMAN OTC DRUG Alka-Seltzer Original ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE TABLET, EFFERVESCENT ORAL 20100302 OTC MONOGRAPH NOT FINAL part343 R J General Corporation ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE 1000; 325; 1916 mg/1; mg/1; mg/1 E 20171231 70264-015_3fcd8fdd-cea7-4ad4-8933-6152e2348b65 70264-015 HUMAN OTC DRUG Alka-Seltzer Plus Cold Medicine Sparkling Original ASPIRIN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE BITARTRATE TABLET, EFFERVESCENT ORAL 20080410 OTC MONOGRAPH NOT FINAL part343 R J General Corporation ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE 325; 2; 7.8 mg/1; mg/1; mg/1 E 20171231 70265-010_6accb6e4-5409-4bbb-b11f-bb6e95ebebb7 70265-010 HUMAN OTC DRUG ALWAYS BRIGHT LIGHTENING OXY PEEL Glycerin SOLUTION TOPICAL 20160201 UNAPPROVED DRUG OTHER DMS INTERNATIONAL CO., LTD. GLYCERIN 6.22 g/100mL N 20181231 70265-020_f2a25950-bcae-4c4e-8918-ff9838ecc028 70265-020 HUMAN OTC DRUG ALWAYS PURE BETA PEEL Witch Hazel SOLUTION TOPICAL 20160201 OTC MONOGRAPH FINAL part347 DMS INTERNATIONAL CO., LTD. WITCH HAZEL .08 g/100mL N 20181231 70265-030_17c43697-f4fa-4902-9582-755d934c21b0 70265-030 HUMAN OTC DRUG ALWAYS BRIGHT EXTRA BRIGHTENING Glycerin CREAM TOPICAL 20160201 UNAPPROVED DRUG OTHER DMS INTERNATIONAL CO., LTD. GLYCERIN 2.85 g/50g N 20181231 70265-040_78ede224-fcbc-42d7-bf1e-74cceeb8e6f4 70265-040 HUMAN OTC DRUG DERMOESSENTIAL POST LNC MIST Glycerin SPRAY TOPICAL 20160201 UNAPPROVED DRUG OTHER DMS INTERNATIONAL CO., LTD. GLYCERIN .13 g/100mL N 20181231 70265-050_e1ca076a-a6eb-4441-9561-57398d0806eb 70265-050 HUMAN OTC DRUG DERMOESSENTIAL POST LNC Glycerin CREAM TOPICAL 20160201 UNAPPROVED DRUG OTHER DMS INTERNATIONAL CO., LTD. GLYCERIN 1.77 g/50g N 20181231 70265-060_dbce0d6c-86c1-46bd-ad3c-3e2df9a80783 70265-060 HUMAN OTC DRUG DERMOESSENTIAL POST LNC SERUM Glycerin CREAM TOPICAL 20160201 UNAPPROVED DRUG OTHER DMS INTERNATIONAL CO., LTD. GLYCERIN 1.9 g/30g N 20181231 70265-070_9f1880c8-28a7-45c0-8dc6-65234d517f23 70265-070 HUMAN OTC DRUG DERMOESSENTIAL SUPER ENZYME Allantoin POWDER TOPICAL 20160201 UNAPPROVED DRUG OTHER DMS INTERNATIONAL CO., LTD. ALLANTOIN .02 g/50g N 20181231 70265-080_373e7a71-d0ff-49f8-a329-3c2a47bc63cc 70265-080 HUMAN OTC DRUG DERMOESSENTIAL SUN RESCUE OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 DMS INTERNATIONAL CO., LTD. OCTINOXATE; OCTISALATE; AVOBENZONE 3.6; 2.4; 1.5 g/50g; g/50g; g/50g N 20181231 70265-090_be031d1b-51c3-4edc-809a-4f76feddd27a 70265-090 HUMAN OTC DRUG DERMOESSENTIAL SUN MIST OCTINOXATE, OCTISALATE, Homosalate, Octocrylene SPRAY TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 DMS INTERNATIONAL CO., LTD. OCTINOXATE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 4.9; 3.5; 3.5; 2.1 g/70mL; g/70mL; g/70mL; g/70mL N 20181231 70265-100_aa65d071-35ee-4a72-8ca1-de072234279e 70265-100 HUMAN OTC DRUG DERMOESSENTIAL REVIVAL BALM Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 DMS INTERNATIONAL CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 5.22; .72 g/50g; g/50g N 20181231 70265-110_e99ab71f-4620-4749-a638-72b334a0c59b 70265-110 HUMAN OTC DRUG ALWAYS PURE FIRST AID TONER Glycerin LIQUID TOPICAL 20160201 UNAPPROVED DRUG OTHER DMS INTERNATIONAL CO., LTD. GLYCERIN 4.5 g/150mL N 20181231 70265-120_d7e33ad9-aa49-4154-b86f-b7b3393b2b7a 70265-120 HUMAN OTC DRUG ALWAYS PURE FIRST AID Glycerin CREAM TOPICAL 20160201 UNAPPROVED DRUG OTHER DMS INTERNATIONAL CO., LTD. GLYCERIN 1.8 g/60mL N 20181231 70265-130_b0bff441-d6d1-47a1-8c3a-99c7d75e63b5 70265-130 HUMAN OTC DRUG ALWAYS PURE SPOT FOR NIGHT Salicylic Acid CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part333D DMS INTERNATIONAL CO., LTD. SALICYLIC ACID .08 g/20mL N 20181231 70265-140_0ea3cf3f-9870-486a-92dc-8a2a93307d91 70265-140 HUMAN OTC DRUG ALWAYS DECONGEST RELIEF AMPLE Glycerin CREAM TOPICAL 20160201 UNAPPROVED DRUG OTHER DMS INTERNATIONAL CO., LTD. GLYCERIN 10 g/100mL N 20181231 70265-150_beaf70c4-eca4-4390-85a2-08439aa5e71e 70265-150 HUMAN OTC DRUG MOISTURE RX RECHARGING Dimethicone CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part347 DMS INTERNATIONAL CO., LTD. DIMETHICONE 7.5 g/150mL N 20181231 70265-160_3b9ad6e9-806d-4a24-9159-88c66083f579 70265-160 HUMAN OTC DRUG ALWAYS SMOOTH REVOLUTION AMPLE Dimethicone CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part347 DMS INTERNATIONAL CO., LTD. DIMETHICONE 2.1 g/100mL N 20181231 70265-170_47900b26-2199-44cd-8131-0f381642a0b9 70265-170 HUMAN OTC DRUG ALWAYS BRIGHT SPOT LUMEDIC Glycerin, Niacinamide CREAM TOPICAL 20160201 UNAPPROVED DRUG OTHER DMS INTERNATIONAL CO., LTD. GLYCERIN; NIACINAMIDE 12.8; 2 g/100mL; g/100mL N 20181231 70265-180_a324dad2-b2df-433b-a865-81b77704809e 70265-180 HUMAN OTC DRUG ALWAYS DECONGEST SOOTHING MASK Glycerin PATCH TOPICAL 20160201 UNAPPROVED DRUG OTHER DMS INTERNATIONAL CO., LTD. GLYCERIN 1.3 g/26mL N 20181231 70266-123_60c72b2c-db5c-764a-e053-2a91aa0a0820 70266-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030515 UNAPPROVED MEDICAL GAS Littleton Homecare Supply, Inc. OXYGEN 99 L/100L N 20181231 70267-001_2d1288fb-61ff-5b9e-e054-00144ff88e88 70267-001 HUMAN OTC DRUG Lidopatch lidocaine, menthol PATCH TOPICAL 20160302 OTC MONOGRAPH NOT FINAL part348 Wuhan Bingbing Pharmaceutical Co., Ltd LIDOCAINE; MENTHOL .036; .0125 mg/1; mg/1 E 20171231 70271-426_926ec8fb-4382-4740-9302-c0d457915248 70271-426 HUMAN PRESCRIPTION DRUG Pyrimethamine Leucovorin Pyrimethamine Leucovorin CAPSULE ORAL 20151127 UNAPPROVED DRUG OTHER ImprimisRx PA, Inc. d/b/a ImprimisRx PYRIMETHAMINE; LEUCOVORIN CALCIUM 25; 5 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70271-427_7c870ebb-789e-4832-a799-c0df4a5094ad 70271-427 HUMAN PRESCRIPTION DRUG Pyrimethamine Leucovorin Pyrimethamine Leucovorin CAPSULE ORAL 20151127 UNAPPROVED DRUG OTHER ImprimisRx PA, Inc. d/b/a ImprimisRx PYRIMETHAMINE; LEUCOVORIN CALCIUM 25; 10 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70271-428_72083fe0-591d-43b7-ac90-146a5b985d2a 70271-428 HUMAN PRESCRIPTION DRUG Pyrimethamine Leucovorin Pyrimethamine Leucovorin CAPSULE ORAL 20151127 UNAPPROVED DRUG OTHER ImprimisRx PA, Inc. d/b/a ImprimisRx PYRIMETHAMINE; LEUCOVORIN CALCIUM 50; 10 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70271-429_1f89552d-6994-4601-9f6b-43b3c7994d4b 70271-429 HUMAN PRESCRIPTION DRUG Pyrimethamine Leucovorin Pyrimethamine Leucovorin CAPSULE ORAL 20151127 UNAPPROVED DRUG OTHER ImprimisRx PA, Inc. d/b/a ImprimisRx PYRIMETHAMINE; LEUCOVORIN CALCIUM 50; 20 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70271-430_02f3ee8d-9861-4519-8041-70d3687199e7 70271-430 HUMAN PRESCRIPTION DRUG Pyrimethamine Leucovorin Pyrimethamine Leucovorin CAPSULE ORAL 20151127 UNAPPROVED DRUG OTHER ImprimisRx PA, Inc. d/b/a ImprimisRx PYRIMETHAMINE; LEUCOVORIN CALCIUM 12.5; 2.5 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70271-480_9616a262-93aa-466e-97c6-5f7e177848e2 70271-480 HUMAN PRESCRIPTION DRUG Pyrimethamine Leucovorin Pyrimethamine Leucovorin CAPSULE ORAL 20151127 UNAPPROVED DRUG OTHER ImprimisRx PA, Inc. d/b/a ImprimisRx PYRIMETHAMINE; LEUCOVORIN CALCIUM 50; 25 mg/1; mg/1 Dihydrofolate Reductase Inhibitor Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Folate Analog [EPC],Folic Acid [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] E 20171231 70273-001_9a727eaf-8e71-4fcf-8208-9df73b055a5e 70273-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS RESPIRATORY (INHALATION) 19920630 NDA NDA205767 A & E Mill & Welding Supply Company OXYGEN 990 mL/L N 20181231 70275-406_617e61a9-0196-0d4e-e053-2a91aa0a3d09 70275-406 HUMAN OTC DRUG SalivaCAINE Benzocaine POWDER, FOR SOLUTION ORAL 20170224 OTC MONOGRAPH NOT FINAL part356 Forward Science Technologies LLC BENZOCAINE 150 mg/3000mg N 20181231 70278-103_93198797-1b1a-44dc-ae21-159a850fbb6c 70278-103 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20161008 ANDA ANDA204854 Daewoong America Inc. MEROPENEM 500 mg/20mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 70278-104_93198797-1b1a-44dc-ae21-159a850fbb6c 70278-104 HUMAN PRESCRIPTION DRUG Meropenem Meropenem INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20161008 ANDA ANDA204854 Daewoong America Inc. MEROPENEM 1 g/30mL Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC] N 20181231 70279-221_b9532b7a-8034-4126-baf2-a9418a76d4d6 70279-221 HUMAN OTC DRUG ECLAIR NATURALS (FRENCH LAVENDER) HAND SANITIZER Ethanol SPRAY TOPICAL 20151229 OTC MONOGRAPH NOT FINAL part333A Dm Natural Products, Inc ALCOHOL 62 mL/100mL E 20171231 70279-235_5e58c06a-1530-48d9-b7fd-95d230eeb27b 70279-235 HUMAN OTC DRUG ECLAIR NATURALS (VANILLA PEPPERMINT) HAND SANITIZER Ethanol SPRAY TOPICAL 20151229 OTC MONOGRAPH NOT FINAL part333A Dm Natural Products, Inc ALCOHOL 62 mL/100mL E 20171231 70279-293_2efc4809-d21c-4756-b03b-d0b8763b09fe 70279-293 HUMAN OTC DRUG HUGO Naturals FRENCH LAVENDER HAND SANITIZER ETHANOL SPRAY TOPICAL 20151229 OTC MONOGRAPH NOT FINAL part333A Dm Natural Products, Inc. ALCOHOL 62 mL/100mL N 20181231 70279-610_5468b804-3364-49e1-ab2b-ed52e997cd2a 70279-610 HUMAN OTC DRUG HUGO Naturals VANILLA PEPPERMINT HAND SANITIZER ETHANOL SPRAY TOPICAL 20151229 OTC MONOGRAPH NOT FINAL part333A Dm Natural Products, Inc. ALCOHOL 62 mL/100mL N 20181231 70281-100_e10a7dd1-0d3c-4fb3-b6e9-d5a1a4750efa 70281-100 HUMAN OTC DRUG NO-AD SPF 8 Tanning octinoxate, octisalate LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC OCTINOXATE; OCTISALATE 4.5; 5 g/100g; g/100g N 20181231 70281-101_966e634f-17e5-4ffb-b7cc-7846e9b29e49 70281-101 HUMAN OTC DRUG NO-AD SPF30 LTN 16OZ Avobenzone, Homosalate, Octisalate and Oxybenzone LOTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2; 10; 5; 3 g/100g; g/100g; g/100g; g/100g N 20181231 70281-102_2dd31504-24e4-4e8c-bcd0-20d5b5f781af 70281-102 HUMAN OTC DRUG NO-AD 45 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-104_5fceafdc-0c40-441d-895d-bececae1a395 70281-104 HUMAN OTC DRUG NO-AD 60 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2.5; 10; 5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-110_ad644ead-acd8-4675-8ab3-b2ad4bcf4bed 70281-110 HUMAN OTC DRUG NO-AD 15 Sunscreen avobenzone, homosalate, octisalate LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE 1.2; 7.5; 5 g/100g; g/100g; g/100g N 20181231 70281-113_66122846-b6d3-49da-b467-72c9f8480a2b 70281-113 HUMAN OTC DRUG NO-AD Kids 50 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-123_0679544f-4c60-4c6b-8033-4164b2ad4a57 70281-123 HUMAN OTC DRUG NO-AD Sport 50 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-134_8d737af2-ef42-4970-91ac-cd444b827961 70281-134 HUMAN OTC DRUG NO-AD SunCare Ltn SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-134_b1bf9484-bee6-4035-b3a0-e50687626ae5 70281-134 HUMAN OTC DRUG NO-AD Suncare Ltn SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone LOTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-174_1349477b-991b-4e57-8877-8a340b6d91e8 70281-174 HUMAN OTC DRUG NO-AD FACE SPF 30 6OZ Avobenzone, Homosalate, Octisalate and Oxybenzone LOTION TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 2; 10; 5; 3 g/100g; g/100g; g/100g; g/100g N 20181231 70281-202_8288b343-d0b7-4840-b561-afbe6a904d7b 70281-202 HUMAN OTC DRUG OP spf45 Lip Potion Clear Zinc Avobenzone, Octyl Salicylate, Octocrylene, Oxybenzone, Octinoxate STICK TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE; OCTINOXATE 2; 5; 5; 5; 7 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-203_a93ca926-e9b7-4d5d-9cea-df5d3d974dd0 70281-203 HUMAN OTC DRUG OP spf45 Face Clear Zinc Potion Octinoxate, Zinc Oxide, Oxybenzone, Octisalate, Octocrylene CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC OCTINOXATE; ZINC OXIDE; OXYBENZONE; OCTISALATE; OCTOCRYLENE 7.5; 7; 5; 5; 2 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-204_9707d04b-c6b6-4beb-815c-3b7afcb5213a 70281-204 HUMAN OTC DRUG Face Potion Avobenzone, homosalate, octisalate, octocrylene LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 g/100g; g/100g; g/100g; g/100g N 20181231 70281-205_8852a8b1-667c-4556-8f16-25a19b574ed9 70281-205 HUMAN OTC DRUG OP spf15 Anti Aging Sunscreen Avobenzone, Homosalate, Octisalate CREAM TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE 1.2; 7.5; 5 g/100g; g/100g; g/100g N 20181231 70281-206_3a4dabc3-99b5-4b62-8bae-0fc23dfd41ed 70281-206 HUMAN OTC DRUG OP spf15 Anti Aging Sunscreen Avobenzone, Homosalate, Octisalate CREAM TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE 1.2; 7.5; 5 g/100g; g/100g; g/100g N 20181231 70281-207_df9e6585-49cd-4f37-9f2d-22e5b3f15fc4 70281-207 HUMAN OTC DRUG OP Sport Sunscreen spf30 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 12; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 70281-208_72c0bd8e-792d-4c81-850d-3ff9755d2afd 70281-208 HUMAN OTC DRUG OP Protect and Nourish SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20170915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 12; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 70281-209_b88388aa-4866-4c76-8c5e-27b77bcf4635 70281-209 HUMAN OTC DRUG OP Sport Sunscreen spf30 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20170915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 12; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 70281-210_33a18f71-4b2d-4a82-8ae2-cc0f3717e8ed 70281-210 HUMAN OTC DRUG OP Protect and Nourish SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20160915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 12; 5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 70281-211_f83cbe7a-fa35-4213-aa54-52a4f7c8abef 70281-211 HUMAN OTC DRUG OP Protect and Renew Face SPF 35 Avobenzone, Homosalate, Octocrylene, Octyl Salicylate LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE 3; 15; 2.7; 5 g/100g; g/100g; g/100g; g/100g N 20181231 70281-212_7a1634d2-0b22-4a67-b230-c6f6d0d400f7 70281-212 HUMAN OTC DRUG OP Protect and Renew Body SPF 45 Avobenzone, Homosalate, Octocrylene, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 3; 15; 2.35; 5; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-214_f327bb59-ffab-4b0e-ad04-0f2162f77077 70281-214 HUMAN OTC DRUG OP Protect and Nourish Kids SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 g/100g; g/100g; g/100g; g/100g N 20181231 70281-215_554d7f9d-7cff-4f88-8b6e-f3f99fc8716a 70281-215 HUMAN OTC DRUG OP Protect and Nourish Babies and Sensitive SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 g/100g; g/100g; g/100g; g/100g N 20181231 70281-216_b4ada4bf-1b90-4a93-b09b-45acc68332df 70281-216 HUMAN OTC DRUG OP Protect and Nourish Kids SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 g/100g; g/100g; g/100g; g/100g N 20181231 70281-217_4fe7d31d-7a1b-4342-9cc7-d365e843058b 70281-217 HUMAN OTC DRUG OP spf50 and Sport Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 g/100g; g/100g; g/100g; g/100g N 20181231 70281-218_1add8094-49f0-4097-8aa9-db94ce94744d 70281-218 HUMAN OTC DRUG OP Protect and Nourish SPF 50 Sunscreen Avobenzone, Homosalate, Octocrylene, Octyl Salicylate, Oxybenzone LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 g/100g; g/100g; g/100g; g/100g N 20181231 70281-219_32a79057-7720-4d3e-bddb-845b885ddc7d 70281-219 HUMAN OTC DRUG OP Protect and Nourish SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene LOTION TOPICAL 20170915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 7 g/100g; g/100g; g/100g; g/100g N 20181231 70281-220_b49ee367-afad-40ef-b5e7-13125202ae4f 70281-220 HUMAN OTC DRUG OP SPF 70 Anti Aging Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 15; 5; 2; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-221_de007ff7-18c5-4791-a32e-7a940a12d789 70281-221 HUMAN OTC DRUG OP SPF 70 Anti Aging Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone LOTION TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 2; 15; 2; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-311_6faa9e01-ada3-4ca1-9dbc-46effd78f0e0 70281-311 HUMAN OTC DRUG BULLFROG DEET FREE Mosquito Coast Sunscreen with Insect Repellent SPF 30 Octinoxate, Octisalate, Octocrylene and Oxybenzone SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 10; 6 g/100g; g/100g; g/100g; g/100g N 20181231 70281-312_78b4f6a9-077b-4065-bfd2-a1c46898e80e 70281-312 HUMAN OTC DRUG BULLFROG DEET FREE Mosquito Coast Sunscreen with Insect Repellent SPF 30 Octinoxate, homosalate, octisalate, octocrylene SPRAY TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC OCTINOXATE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 5; 7.5; 10; 6 g/100g; g/100g; g/100g; g/100g N 20181231 70281-323_0ca948d1-a8e6-41c4-88da-469b145f7e58 70281-323 HUMAN OTC DRUG BullFrog SPF50 Water Sport C-Spray Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-333_b523347e-aa1d-4717-886b-b1e2e14a7453 70281-333 HUMAN OTC DRUG BullFrog SPF50 Land Sport C-Spray Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone SPRAY TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 2; 5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70281-337_c12abd99-95fa-42cc-a956-413eb1b88f27 70281-337 HUMAN OTC DRUG BullFrog Land Sport SPF 50 Quik homosalate, octinoxate, octisalate, octocrylene, zinc oxide STICK TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 6; 7.5; 5; 5; 10 mg/100mg; mg/100mg; mg/100mg; mg/100mg; mg/100mg N 20181231 70281-338_c8328da7-bd73-4c1f-91b8-d9e8437e7147 70281-338 HUMAN OTC DRUG BullFrog SPF50 Land Sport Quik avobenzone, homosalate, octisalate, octocrylene, oxybenzone GEL TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 5; 10; 6 mg/100mg; mg/100mg; mg/100mg; mg/100mg; mg/100mg N 20181231 70281-339_ec345c44-c3af-4a95-bf7d-5d0eee3d8687 70281-339 HUMAN OTC DRUG BullFrog Land Sport SPF 50 Lip Balm AVOBENZONE, OCTISALATE, OCTOCRYLENE and OXYBENZONE STICK TOPICAL 20150915 OTC MONOGRAPH NOT FINAL part352 SolSkyn Personal Care LLC AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 4; 10; 6 g/100g; g/100g; g/100g; g/100g N 20181231 70287-716_482e2384-ef08-01c7-e054-00144ff88e88 70287-716 HUMAN OTC DRUG Velatrin Pain Relief METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM CREAM TOPICAL 20151125 OTC MONOGRAPH NOT FINAL part348 Quality Nature, Inc. METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM 15; 10 mg/g; mg/g N 20181231 70288-714_48a71929-e88f-5972-e054-00144ff8d46c 70288-714 HUMAN OTC DRUG Ana Cool Rapid Soothing Cooling Formula HYDROCORTISONE CREAM TOPICAL 20151125 OTC MONOGRAPH NOT FINAL part348 Ana-Cool, LLC HYDROCORTISONE 10 mg/g N 20181231 70291-1000_2c87c66c-2512-1fa6-e054-00144ff88e88 70291-1000 HUMAN PRESCRIPTION DRUG Focus Medical Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20151101 UNAPPROVED MEDICAL GAS Focus Medical Gases LLC OXYGEN 1 L/L N 20181231 70295-123_25d933f6-09c7-5d03-e054-00144ff8d46c 70295-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030515 UNAPPROVED MEDICAL GAS American Home Medical Services OXYGEN 99 L/100L E 20171231 70299-001_2616f770-6743-53f7-e054-00144ff88e88 70299-001 HUMAN OTC DRUG Vytis Shield Aloe Vera Foam Hand Sanitizer BENZALKONIUM CHLORIDE SPRAY TOPICAL 20151203 OTC MONOGRAPH NOT FINAL part333E Vytis Shield, Llc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 70300-001_5e44788a-21f9-4885-e053-2a91aa0a5bd0 70300-001 HUMAN PRESCRIPTION DRUG oxygen oxygen GAS NASAL; RESPIRATORY (INHALATION) 20150101 UNAPPROVED MEDICAL GAS Brainerd Medical Supply, Inc. OXYGEN 1 L/L N 20181231 70301-1001_19d54886-06cf-4b85-85f3-db5257c9379a 70301-1001 HUMAN PRESCRIPTION DRUG Rayaldee calcifediol CAPSULE, EXTENDED RELEASE ORAL 20161025 NDA NDA208010 OPKO Pharmaceuticals LLC CALCIFEDIOL 30 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20191231 70303-123_25d9728f-6a57-65ab-e054-00144ff8d46c 70303-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20030515 UNAPPROVED MEDICAL GAS Merced Medical Supplies OXYGEN 99 L/100L E 20171231 70305-000_24c29d34-fa24-18d2-e054-00144ff8d46c 70305-000 HUMAN PRESCRIPTION DRUG Oxygen, Refrigerated Liquid Oxygen GAS RESPIRATORY (INHALATION) 20100416 UNAPPROVED MEDICAL GAS Connecticut Support Services Holdings, LLC OXYGEN 1 L/L E 20171231 70306-1851_2690d745-43f6-69e1-e054-00144ff88e88 70306-1851 HUMAN OTC DRUG diaper rash cream Zinc Oxide CREAM TOPICAL 20160301 OTC MONOGRAPH FINAL part347 giggle ZINC OXIDE 19 g/100mL E 20171231 70306-5357_25db0c84-8b91-5637-e054-00144ff88e88 70306-5357 HUMAN OTC DRUG sunscreen zinc oxide, titanium dioxide LOTION TOPICAL 20160315 OTC MONOGRAPH NOT FINAL part352 giggle ZINC OXIDE; TITANIUM DIOXIDE 9; 7 g/100mL; g/100mL E 20171231 70306-9804_2b73aa6c-4c38-3b66-e054-00144ff88e88 70306-9804 HUMAN OTC DRUG body care gift set Zinc Oxide KIT 20160301 OTC MONOGRAPH FINAL part347 giggle E 20171231 70309-080_2655e449-dee0-57d1-e054-00144ff88e88 70309-080 HUMAN OTC DRUG PinAway Pyrantel pamoate SUSPENSION ORAL 20151207 OTC MONOGRAPH FINAL part357B Cara, Incorporated PYRANTEL PAMOATE 144 mg/mL N 20181231 70314-201_decde447-5615-4c97-8c26-a323100476d0 70314-201 HUMAN OTC DRUG FACIAL WITH PLACENTA PROTEIN SPF-15 TITANIUM DIOXIDE OIL TOPICAL 20151201 OTC MONOGRAPH FINAL part352 BILL BEAUTY AND HEALTH PRODUCTS LTD TITANIUM DIOXIDE 5 g/100mL E 20171231 70315-000_32aa3772-8440-2d4a-e054-00144ff88e88 70315-000 HUMAN OTC DRUG Natural Sunscreen Zinc Oxide CREAM TOPICAL 20150507 OTC MONOGRAPH FINAL part352 A Bit Hippy ZINC OXIDE 24.96 g/100g N 20181231 70315-001_26f10bf1-230d-027c-e054-00144ff88e88 70315-001 HUMAN OTC DRUG A Bit Hippy Colloidal Oatmeal 2% CREAM TOPICAL 20151215 UNAPPROVED HOMEOPATHIC A Bit Hippy OATMEAL .2 g/1 N 20181231 70316-320_285e93ce-5fa7-2f7b-e054-00144ff8d46c 70316-320 HUMAN OTC DRUG Sno Swedish Arctic Gel Support camphor, menthol GEL TOPICAL 20160102 OTC MONOGRAPH NOT FINAL part348 Natumin Pharma AB CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM 2.8; 2.25 g/100g; g/100g N 20181231 70316-330_28973151-7560-6cd8-e054-00144ff88e88 70316-330 HUMAN OTC DRUG Sno Swedish Arctic Gel Relief camphor, menthol GEL TOPICAL 20160105 OTC MONOGRAPH NOT FINAL part348 Natumin Pharma AB CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM 2.2; 3.6 g/100g; g/100g N 20181231 70316-360_271a556c-2760-2d15-e054-00144ff88e88 70316-360 HUMAN OTC DRUG Sno Swedish Arctic Gel Recovery menthol GEL TOPICAL 20151218 OTC MONOGRAPH NOT FINAL part348 Natumin Pharma AB MENTHOL, UNSPECIFIED FORM 2.25 g/100g N 20181231 70319-005_8081a7bf-0d7a-4ea0-885b-4429ddc8a77f 70319-005 HUMAN OTC DRUG Aloe Soothing Suncream OCTINOXATE,TITANIUM DIOXIDE CREAM TOPICAL 20171218 OTC MONOGRAPH NOT FINAL part352 COSRX inc. OCTINOXATE; TITANIUM DIOXIDE 3.6; .74 mg/50mL; mg/50mL N 20181231 70319-012_b3844677-33aa-4bbe-ad82-6ca80dad3d78 70319-012 HUMAN OTC DRUG Salicylic Acid Daily Gentle Cleanser Salicylic Acid GEL TOPICAL 20170507 OTC MONOGRAPH FINAL part333D COSRX inc. SALICYLIC ACID .75 mg/150mL N 20181231 70321-0001_b3774d72-5888-44cc-880c-cabd4217713e 70321-0001 HUMAN OTC DRUG Energize Colchicum Autumnale, Conium Maculatum, Hydrastis Canadensis, Vaccinium Myrtillus, Podophyllum Peltatum, Ascorbic Acid, Galium Aparine, Nicotinamidum, Pyridoxinum Hydrochloricum, Riboflavinum, Sarcolacticum Acidum, Norepinephrine, Alpha-Lipoicum Acidum, Natrum Oxalaceticum, Sulphur, Acetylsalicylicum Acidum, Anthraquinone, Coenzyme A, Histaminum Hydrochloricum, Magnesium Gluconate, Nadidum, Naphthoquinone, Ubidecarenonum, Magnesium Phosphoricum, Hydroquinone, Morgan Gaertner LIQUID ORAL 20160310 20210323 UNAPPROVED HOMEOPATHIC Parasitology Center, Inc. COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; BILBERRY; PODOPHYLLUM; ASCORBIC ACID; GALIUM APARINE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; LACTIC ACID, L-; THIAMINE HYDROCHLORIDE; NOREPINEPHRINE; THIOCTIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; ASPIRIN; ADENOSINE TRIPHOSPHATE DISODIUM; ANTHRAQUINONE; COENZYME A; HISTAMINE DIHYDROCHLORIDE; MAGNESIUM GLUCONATE; NADIDE; 1,4-NAPHTHOQUINONE; UBIDECARENONE; MANGANESE PHOSPHATE, DIBASIC; HYDROQUINONE; PROTEUS MORGANII 4; 4; 4; 4; 5; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 70321-0002_c8b036c1-1366-4707-8f26-5778fc3335b7 70321-0002 HUMAN OTC DRUG Immuno-Boost Beta Vulgaris, Cysteinum, Natrum Oxalaceticum, Nicotinamidum, Pulsatilla (Vulgaris), Pyridoxinum Hydrochloricum, Riboflavinum, Thiaminum Hydrochloricum, Adrenalinum, Aconiticum Acidum, CIS-, Alpha-Ketoglutaricum Acidum, Alpha-Lipoicum Acidum, Cerium Oxalicum, Citricum Acidum, Coenzyme A, Fumaricum Acidum, Magnesium Orotate, Malic Acid, Nadidum, Natrum Pyruvicum, Succinicum Acidum, Adenosinum Triphosphoricum Acidum, Hepar Sulphuris Calcareum, Sulphur, Manganum Phosphoricum, Baryta Oxalsuccinicum, LIQUID ORAL 20160322 UNAPPROVED HOMEOPATHIC Parasitology Center, Inc. BETA VULGARIS; ASCORBIC ACID; CYSTEINE; SODIUM DIETHYL OXALACETATE; NIACINAMIDE; ANEMONE PULSATILLA; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; EPINEPHRINE; ACONITIC ACID; OXOGLURIC ACID; THIOCTIC ACID; CEROUS OXALATE NONAHYDRATE; ANHYDROUS CITRIC ACID; COENZYME A; FUMARIC ACID; MAGNESIUM OROTATE; MALIC ACID; NADIDE; SODIUM PYRUVATE; SUCCINIC ACID; ADENOSINE TRIPHOSPHATE DISODIUM; CALCIUM SULFIDE; SULFUR; MANGANESE PHOSPHATE, DIBASIC; BARIUM OXALOSUCCINATE; PROTEUS MORGANII 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 10; 10; 10; 16; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 70321-0003_a135565d-8c93-458b-ad68-3aab3acb954d 70321-0003 HUMAN OTC DRUG Energize Colchicum Autumnale, Conium Maculatum, Hydrastis Canadensis, Vaccinium Myrtillus, Podophyllum Peltatum, Ascorbic Acid, Galium Aparine, Nicotinamidum, Pyridoxinum Hydrochloricum, Riboflavinum, Sarcolacticum Acidum, Thiaminum Hydrochloricum, Norepinephrine, Alpha-Lipoicum Acidum, Natrum Oxalaceticum, Sulphur, Acetylsalicylicum Acidum, Adenosinum Triphosphoricum Dinatrum, Anthrachinonum, Histaminum Hydrochloricum, Magnesium Gluconicum Dihydricum, Nadidum, Naphthochinonum, Pantothenic Acid LIQUID ORAL 20160427 UNAPPROVED HOMEOPATHIC Parasitology Center Inc. COLCHICUM AUTUMNALE BULB; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; BILBERRY; PODOPHYLLUM; ASCORBIC ACID; GALIUM APARINE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; LACTIC ACID, L-; THIAMINE HYDROCHLORIDE; NOREPINEPHRINE; THIOCTIC ACID; SODIUM DIETHYL OXALACETATE; SULFUR; ASPIRIN; ADENOSINE TRIPHOSPHATE DISODIUM; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; HISTAMINE DIHYDROCHLORIDE; MAGNESIUM GLUCONATE; NADIDE; 1,4-NAPHTHOQUINONE; PANTOTHENIC ACID; UBIDECARENONE; MANGANESE PHOSPHATE, DIBASIC; HYDROQUININE; SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS 4; 4; 4; 4; 5; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 3; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 70323-123_60c70d70-aa02-7644-e053-2a91aa0a7cf6 70323-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20010301 UNAPPROVED MEDICAL GAS Inmon Respiratory Services Inc. OXYGEN 99 L/100L N 20181231 70325-3001_a08b00d9-d8d9-41b8-9a9b-b0ba0c5f8c08 70325-3001 HUMAN OTC DRUG bu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance Free OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE SPRAY TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 Bu Brands, LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 7.5; 7.5; 5; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 70325-3002_4be44fdc-8d49-43b4-9f1f-f0cc67d4f602 70325-3002 HUMAN OTC DRUG bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage Scent OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE SPRAY TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 Bu Brands, LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 7.5; 7.5; 5; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 70325-3003_4cffcafb-2cc5-4103-ac59-8528270df0d9 70325-3003 HUMAN OTC DRUG bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus Scent OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE SPRAY TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 Bu Brands, LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 7.5; 7.5; 5; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 70325-5001_3ed1c4fd-a281-439e-aac5-4c86658861ae 70325-5001 HUMAN OTC DRUG bu SPF 50 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance Free OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, and HOMOSALATE SPRAY TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 Bu Brands, LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE 7.5; 10; 5; 3; 7.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 70325-5002_d4c18d4c-9084-4316-ad6e-d6b37966ef6b 70325-5002 HUMAN OTC DRUG bu SPF 50 KIDS Broad Spectrum Alcohol-Free Performance Sunscreen - Fragrance Free OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, and HOMOSALATE SPRAY TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 Bu Brands, LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE 7.5; 10; 5; 3; 7.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 70325-5003_12cfb872-05c5-4612-9c04-e0db090746f1 70325-5003 HUMAN OTC DRUG bu SPF 50 S Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage Scent OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, and HOMOSALATE SPRAY TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 Bu Brands, LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE 7.5; 10; 5; 3; 7.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 70326-101_637c1170-1d65-4ff5-ad0e-9d108ea78b42 70326-101 HUMAN OTC DRUG Plalab Placenta Peeling JUGLANS REGIA SHELL GEL TOPICAL 20151222 UNAPPROVED DRUG OTHER RENOCELL Co., Ltd JUGLANS REGIA SHELL .005 1/80mL E 20171231 70326-102_81cd3bb0-b94e-4eb6-9233-425cc2605457 70326-102 HUMAN OTC DRUG Plalab Placenta Ample Essence NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20151223 UNAPPROVED DRUG OTHER RENOCELL Co., Ltd NIACINAMIDE; ADENOSINE .02; .0004 1/50mL; 1/50mL E 20171231 70326-103_c67f5f81-38fe-4709-a01a-459b00984bda 70326-103 HUMAN OTC DRUG Plalab Placenta R-20 NIACINAMIDE, ADENOSINE CREAM TOPICAL 20151223 UNAPPROVED DRUG OTHER RENOCELL Co., Ltd NIACINAMIDE; ADENOSINE .02; .0004 1/50mL; 1/50mL E 20171231 70326-104_a578a8cf-b315-4cb2-8b98-cf88487fb7dc 70326-104 HUMAN OTC DRUG Plalab Placenta Mask NIACINAMIDE, ADENOSINE PATCH TOPICAL 20151223 UNAPPROVED DRUG OTHER RENOCELL Co., Ltd NIACINAMIDE; ADENOSINE .02; .0004 1/25mL; 1/25mL E 20171231 70326-105_e71b23a4-4884-4a52-8697-fe382f16db3b 70326-105 HUMAN OTC DRUG Plalab Placenta Skin Booster NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20151223 UNAPPROVED DRUG OTHER RENOCELL Co., Ltd NIACINAMIDE; ADENOSINE .02; .0004 1/120mL; 1/120mL E 20171231 70327-0001_cb001fb8-4417-4835-9b69-c61e3186cfed 70327-0001 HUMAN OTC DRUG Natural Fit Kali Phosphoricum, Natrum Sulphuricum, Agnus Castus, Chelidonium Majus, Fucus Vesiculosus, Lycopodium Clavatum, Thuja Occidentalis, Capsicum Annuum, Carduus Marianus, Cysteinum, Gambogia, Hydrocotyle Asiatica, Kali Carbonicum, Nux Vomica, Phytolacca Decandra, Rosa Canina, Flos, Salix Alba, Thea Sinensis, Carbo Vegetabilis, Calcarea Carbonica, Graphites, Natrum Muriaticum, Natrum Phosphoricum, Glandula Suprarenalis Suis, Hepar Suis, Pancreas Suis, Pituitarum Posterium (Bovine), Placenta Totalis Suis LIQUID ORAL 20160121 UNAPPROVED HOMEOPATHIC Advanced Healthcare Solutions POTASSIUM PHOSPHATE, DIBASIC; SODIUM SULFATE; CHASTE TREE; CHELIDONIUM MAJUS; FUCUS VESICULOSUS; LYCOPODIUM CLAVATUM SPORE; THUJA OCCIDENTALIS LEAFY TWIG; CAPSICUM; MILK THISTLE; CYSTEINE; GAMBOGE; CENTELLA ASIATICA; POTASSIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; ROSA CANINA FLOWER; SALIX ALBA BARK; GREEN TEA LEAF; ACTIVATED CHARCOAL; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SUS SCROFA ADRENAL GLAND; PORK LIVER; SUS SCROFA PANCREAS; BOS TAURUS PITUITARY GLAND; SUS SCROFA PLACENTA; THYROID, BOVINE; WATER; GYMNEMA SYLVESTRE LEAF 3; 3; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 70329-717_482d946f-6265-0db3-e054-00144ff8d46c 70329-717 HUMAN OTC DRUG Teeter reNEW MUSCLES Pain Relieving METHYL SALICYLATE, MENTHOL CREAM TOPICAL 20151209 OTC MONOGRAPH NOT FINAL part348 STL International INC METHYL SALICYLATE; MENTHOL 10; 7 mg/g; mg/g N 20181231 70329-730_482d946f-6276-0db3-e054-00144ff8d46c 70329-730 HUMAN OTC DRUG Teeter Renew Muscles Pain Relieving METHYL SALICYLATE, MENTHOL CREAM TOPICAL 20160312 OTC MONOGRAPH NOT FINAL part348 STL International INC METHYL SALICYLATE; MENTHOL 100; 70 mg/mL; mg/mL N 20181231 70329-829_50d7863f-fbc2-7330-e054-00144ff8d46c 70329-829 HUMAN OTC DRUG Teeter ReNew Pain Relief METHYL SALICYLATE, MENTHOL CREAM TOPICAL 20170525 OTC MONOGRAPH NOT FINAL part348 STL International, Inc. METHYL SALICYLATE; MENTHOL 100; 70 mg/g; mg/g N 20181231 70332-101_c107b5b2-6eba-429b-a8de-d713b791d3fe 70332-101 HUMAN PRESCRIPTION DRUG KETOPHENE KETOPHENE KIT 20160101 UNAPPROVED DRUG OTHER California Pharmaceuticals, LLC N 20181231 70332-102_99221323-f45d-4d12-abe4-0114ea75c187 70332-102 HUMAN PRESCRIPTION DRUG CYCLOPHENE CYCLOPHENE KIT 20160101 UNAPPROVED DRUG OTHER California Pharmaceuticals LLC N 20181231 70332-103_28c7a185-4081-1448-e054-00144ff8d46c 70332-103 HUMAN PRESCRIPTION DRUG Dicopanol Diphenhydramine Hydrochloride KIT ORAL 20160101 UNAPPROVED DRUG OTHER California Pharmaceuticals LLC N 20181231 70332-105_28c7b43b-5ce4-60a0-e054-00144ff88e88 70332-105 HUMAN PRESCRIPTION DRUG Fanatrex Gabapentin KIT ORAL 20160101 UNAPPROVED DRUG OTHER California Pharmaceuticals, LLC N 20181231 70332-106_273003a5-23aa-21e4-e054-00144ff88e88 70332-106 HUMAN PRESCRIPTION DRUG Tabradol Cyclobenzaprine Hydrochloride KIT ORAL 20160101 UNAPPROVED DRUG OTHER California Pharmaceuticals, LLC N 20181231 70332-107_562db456-5b88-525d-e054-00144ff88e88 70332-107 HUMAN PRESCRIPTION DRUG SYNAPRYN TRAMADOL HYDROCHLORIDE KIT 20170501 UNAPPROVED DRUG OTHER California Pharmaceuticals, LLC N 20181231 70332-109_6209ffbb-d545-23e4-e053-2991aa0abfa3 70332-109 HUMAN PRESCRIPTION DRUG Ranitidine Hydrochloride Oral Suspension Kit RANITIDINE HYDROCHLORIDE KIT 20170102 UNAPPROVED DRUG OTHER California Pharmaceuticals, LLC N 20191231 70332-300_55eebe36-e733-5c58-e054-00144ff8d46c 70332-300 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE TABLET, DELAYED RELEASE ORAL 20170701 ANDA ANDA205119 California Pharmaceuticals LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 70332-301_61cf498c-d6b9-5e26-e053-2991aa0a59c7 70332-301 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20180102 ANDA ANDA078281 California Pharmaceutical, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 70332-310_5d135044-6049-180a-e053-2991aa0ab763 70332-310 HUMAN PRESCRIPTION DRUG OXAPROZIN OXAPROZIN TABLET, FILM COATED ORAL 20170701 ANDA ANDA075855 California Pharmaceuticals LLC OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70332-311_61cf2924-8dc1-7f5c-e053-2991aa0ac527 70332-311 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20180102 ANDA ANDA208633 California Pharmaceutical LLC OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 70332-320_5d135044-5ff9-180a-e053-2991aa0ab763 70332-320 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170803 ANDA ANDA091134 California Pharmaceuticals, LLC ETODOLAC 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70332-330_61ceb7b5-843b-1166-e053-2a91aa0a3982 70332-330 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20170804 ANDA ANDA204770 California Pharmaceuticals, LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20191231 70334-152_31512ece-cacb-2a9a-e054-00144ff88e88 70334-152 HUMAN OTC DRUG DIABETIC SKIN CARE FORMULA ZINC ACETATE SOAP TOPICAL 20160331 OTC MONOGRAPH NOT FINAL part348 K5 BRANDS, LLC ZINC ACETATE .0025 mg/mg E 20171231 70335-301_3c017550-f152-3087-e054-00144ff8d46c 70335-301 HUMAN OTC DRUG GERMISEPT Antibacterial Hand Sanitizing Wipes BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160906 OTC MONOGRAPH NOT FINAL part333E Innovent Inc. BENZALKONIUM CHLORIDE .12 g/100g N 20181231 70336-718_482d946f-6293-0db3-e054-00144ff8d46c 70336-718 HUMAN OTC DRUG Ted s Pain METHYL SALICYLATE CREAM TOPICAL 20151214 OTC MONOGRAPH NOT FINAL part348 Cersci Therepeutics, Inc. METHYL SALICYLATE 100 mg/g N 20181231 70341-010_6b5cca34-e8ed-4399-b9e0-6b8fadf8d471 70341-010 HUMAN OTC DRUG Mineral Homme White Niacinamide EMULSION TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 2.6 g/130mL N 20181231 70341-020_b656c719-4421-435c-8f56-365505ec6e86 70341-020 HUMAN OTC DRUG Mineral Homme White Toner Niacinamide LIQUID TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 2.6 g/130mL N 20181231 70341-030_ed93537c-55f9-47d8-99a5-49dc7180cb42 70341-030 HUMAN OTC DRUG Cell Renew Bio Micro Peel Soft Glycerin GEL TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. GLYCERIN .16 g/160mL N 20181231 70341-040_38a81ab9-a787-4630-9491-95dba2f3b909 70341-040 HUMAN OTC DRUG Cell Renew Bio Eye Special Set Dimethicone CREAM TOPICAL 20151201 OTC MONOGRAPH FINAL part347 The Saem International Co., Ltd. DIMETHICONE .75 g/30mL N 20181231 70341-050_4ad68a98-83a2-491a-98d3-0081e2dc764b 70341-050 HUMAN OTC DRUG Cell Renew Bio Niacinamide EMULSION TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 3 g/150mL N 20181231 70341-060_e05ec67e-4c25-43f2-a04f-3099900d4e79 70341-060 HUMAN OTC DRUG Cell Renew Bio Essence Special Set Dimethicone CREAM TOPICAL 20151201 OTC MONOGRAPH FINAL part347 The Saem International Co., Ltd. DIMETHICONE 1.2 g/60mL N 20181231 70341-070_08fa4b05-ada9-48de-85ef-de49aa9ddf24 70341-070 HUMAN OTC DRUG Cell Renew Bio Special Set Dimethicone CREAM TOPICAL 20151201 OTC MONOGRAPH FINAL part347 The Saem International Co., Ltd. DIMETHICONE 2.4 g/60mL N 20181231 70341-080_7ac709d8-8a1d-4c8c-8be3-dbaf7810a6c4 70341-080 HUMAN OTC DRUG Cell Renew Bio Toner Niacinamide LIQUID TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 3 g/150mL N 20181231 70341-090_52d57997-acd1-4141-8e26-be5f411c0ba2 70341-090 HUMAN OTC DRUG Power Ampoule Anti wrinkle GLYCERIN SOLUTION TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. GLYCERIN 2.37 g/40mL N 20181231 70341-100_eea892dd-e080-4695-9b4c-bfdd611f2e1d 70341-100 HUMAN OTC DRUG Snail Essential EX Wrinkle Mask Sheet GLYCERIN PATCH TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. GLYCERIN 1.96 g/28g N 20181231 70341-110_4aaefb58-522f-43fd-b4f2-2e2049785a70 70341-110 HUMAN OTC DRUG Snail Essential EX Wrinkle Sun OCTINOXATE, ZINC OXIDE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. OCTINOXATE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE 3.06; 2.25; 2.02; 1.8 g/45mL; g/45mL; g/45mL; g/45mL N 20181231 70341-120_185c0fa2-b842-4dca-b461-40e9d481f474 70341-120 HUMAN OTC DRUG Snail Essential EX Wrinkle Eye DIMETHICONE CREAM TOPICAL 20151201 OTC MONOGRAPH FINAL part347 The Saem International Co., Ltd. DIMETHICONE .6 g/30mL N 20181231 70341-130_9258fb6b-b940-4683-ba44-f28bb5414c99 70341-130 HUMAN OTC DRUG Snail Essential EX Wrinkle DIMETHICONE EMULSION TOPICAL 20151201 OTC MONOGRAPH FINAL part347 The Saem International Co., Ltd. DIMETHICONE 1.5 g/150mL N 20181231 70341-140_cad8b994-9a15-4311-a6db-e6979d2f76bc 70341-140 HUMAN OTC DRUG Snail Essential EX Wrinkle Essence NIACINAMIDE CREAM TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 1 g/50mL N 20181231 70341-150_55a53dcb-2d49-44b6-8d36-3c173960a341 70341-150 HUMAN OTC DRUG Snail Essential EX Wrinkle GLYCERIN CREAM TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. GLYCERIN 5.82 g/60mL N 20181231 70341-160_b2ec649e-51f7-4c6f-a1aa-1f6db5a3b00d 70341-160 HUMAN OTC DRUG Snail Essential EX Wrinkle Toner GLYCERIN LIQUID TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. GLYCERIN 13.5 g/150mL N 20181231 70341-170_e6735f94-f435-4578-9bb1-49584d09091a 70341-170 HUMAN OTC DRUG Eco Soul Luminous Original BB 01 Light Beige Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5.22; .72 g/50mL; g/50mL N 20181231 70341-180_136753ae-5771-4651-a56d-2157550578d5 70341-180 HUMAN OTC DRUG Eco Soul Luminous Original BB 02 Natural Beige Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 5.22; .72 g/50mL; g/50mL N 20181231 70341-190_43193168-c979-4de3-a7fd-0080356fe163 70341-190 HUMAN OTC DRUG Eco Soul Luminous Photoshop Pact 21 Light Beige Titanium Dioxide, Octinoxate, Zinc Oxide POWDER TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .68; .44; .21 g/11g; g/11g; g/11g N 20181231 70341-200_7b537f8c-e1d0-482e-a00e-e4d3acc07732 70341-200 HUMAN OTC DRUG Eco Soul Luminous Photoshop Pact 23 Natural Beige Titanium Dioxide, Octinoxate, Zinc Oxide POWDER TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .68; .44; .21 g/11g; g/11g; dL/11g N 20181231 70341-210_542ffe90-2b45-4051-b564-18ccf4a88320 70341-210 HUMAN OTC DRUG Eco Soul Spau BB Cake 01 Light Beige Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.62; 1.26; .86; .36; .36 g/18g; g/18g; g/18g; g/18g; g/18g N 20181231 70341-220_c44a2026-535f-4495-8b9a-bc1b941196d5 70341-220 HUMAN OTC DRUG Eco Soul Spau BB Cake 02 Natural Beige Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.62; 1.26; .86; .36; .36 g/18g; g/18g; g/18g; g/18g; g/18g N 20181231 70341-230_461f63e6-e5e0-472e-8fb1-d44bcafe4d7e 70341-230 HUMAN OTC DRUG Eco Soul Spau BB Cushion 01 Light Beige Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.17; .91; .62; .26; .26 g/13g; g/13g; g/13g; g/13g; g/13g N 20181231 70341-240_aa12134c-b3e2-4f26-ae05-38d5f828d29c 70341-240 HUMAN OTC DRUG Eco Soul Spau BB Cushion 02 Natural Beige Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.17; .91; .62; .26; .26 g/13g; g/13g; g/13g; g/13g; g/13g N 20181231 70341-250_1379f422-a0a7-4944-a4c1-740921f3ade1 70341-250 HUMAN OTC DRUG Eco Soul Spau BB 01 Light Beige Titanium Dioxide, Octinoxate, Octisalate GEL TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 3.26; 2.8; 1.2 g/40mL; g/40mL; g/40mL N 20181231 70341-260_4a699b4f-f55e-4a74-8b32-80453a559d35 70341-260 HUMAN OTC DRUG Eco Soul Spau BB 02 Natural Beige Titanium Dioxide, Octinoxate, Octisalate GEL TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 3.26; 2.8; 1.2 g/40mL; g/40mL; g/40mL N 20181231 70341-270_67a1d596-a840-44d8-af32-d6d7340ab0f4 70341-270 HUMAN OTC DRUG Eco Soul Power Proof Cooling BB Cushion 01 Aqua Beige Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide POWDER TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 1.17; .91; .62; .26 g/13g; g/13g; g/13g; g/13g N 20181231 70341-280_b66ffffa-8e98-4932-be8f-6a570a76f0cf 70341-280 HUMAN OTC DRUG Eco Soul Power Proof Cooling BB Cushion 02 Neutral Beige Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide POWDER TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 1.17; .91; .62; .26 g/13g; g/13g; g/13g; g/13g N 20181231 70341-290_7d0018a4-d652-45d5-a471-6b75e25d6026 70341-290 HUMAN OTC DRUG ECO EARTH POWER Light Sun Octinoxate, Octisalate, ENSULIZOLE, Octocrylene, AVOBENZONE CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. OCTINOXATE; OCTISALATE; ENSULIZOLE; OCTOCRYLENE; AVOBENZONE 3.75; 2.5; 1.5; 1; .5 g/50g; g/50g; g/50g; g/50g; g/50g N 20181231 70341-300_8c8de487-2ad9-48a0-93de-10a4c27f2e91 70341-300 HUMAN OTC DRUG ECO EARTH POWER Aqua Sun Octinoxate, Octocrylene, Octisalate GEL TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. OCTINOXATE; OCTOCRYLENE; OCTISALATE 4.2; 3; 2.7 g/60g; g/60g; g/60g N 20181231 70341-310_ba36a07b-1211-445a-af7a-de478c029d67 70341-310 HUMAN OTC DRUG Gem Miracle Black Pearl O2 Whitening Snow Serum Niacinamide CREAM TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 1 g/50mL N 20181231 70341-320_96fa269a-7ac9-46a1-95e3-ae9e0c93bbd2 70341-320 HUMAN OTC DRUG Gem Miracle Black Pearl O2 Whitening Niacinamide EMULSION TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 3 g/150mL N 20181231 70341-330_e509d284-d4c3-47a0-a829-f256afe873a2 70341-330 HUMAN OTC DRUG Gem Miracle Black Pearl O2 Whitening Niacinamide CREAM TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 1.2 g/60mL N 20181231 70341-340_365f5a7c-5b11-4839-ae54-9c4078a1c189 70341-340 HUMAN OTC DRUG Gem Miracle Black Pearl O2 Whitening Toner Niacinamide LIQUID TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 3 g/150mL N 20181231 70341-350_3f745e9f-cbd9-47e6-84cd-3a4af062aa18 70341-350 HUMAN OTC DRUG CHAGA Anti Wrinkle Serum with fermented chaga extract Dimethicone CREAM TOPICAL 20151201 OTC MONOGRAPH FINAL part347 The Saem International Co., Ltd. DIMETHICONE 3.9 g/65mL N 20181231 70341-360_221ef3e9-ded7-45b9-9727-de3a11fbeadf 70341-360 HUMAN OTC DRUG CHAGA Anti Wrinkle Skin with fermented chaga extract Niacinamide LIQUID TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 3.2 g/160mL N 20181231 70341-370_7f23964f-bd5f-43d1-a194-2c95a2ede430 70341-370 HUMAN OTC DRUG CHAGA Anti Wrinkle Eye with fermented chaga extract Niacinamide CREAM TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE .4 g/20mL N 20181231 70341-380_3a068beb-2322-4f05-af78-0a6d4b608189 70341-380 HUMAN OTC DRUG CHAGA Anti Wrinkle with fermented chaga extract Niacinamide EMULSION TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 2.8 g/140mL N 20181231 70341-390_603257d3-1046-4ab1-af80-b1176ea062d4 70341-390 HUMAN OTC DRUG CHAGA Anti Wrinkle with fermented chaga extract Dimethicone CREAM TOPICAL 20151201 OTC MONOGRAPH FINAL part347 The Saem International Co., Ltd. DIMETHICONE .6 g/60mL N 20181231 70341-400_304fa92e-5a65-477f-89ac-3c5d429fbb76 70341-400 HUMAN OTC DRUG COVER PERFECTION IDEAL CONCEALER DUO 01 CLEAR BEIGE Dimethicone STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part347 The Saem International Co., Ltd. DIMETHICONE .66 g/8.5g N 20181231 70341-410_58fce6e2-83a1-4eff-a033-99ceae1f5b88 70341-410 HUMAN OTC DRUG COVER PERFECTION IDEAL CONCEALER DUO 02 RICH BEIGE Dimethicone STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part347 The Saem International Co., Ltd. DIMETHICONE .66 g/8.5g N 20181231 70341-420_56bf4a13-1cae-4707-892e-fad40ba55545 70341-420 HUMAN OTC DRUG Cover Perfection Ideal Concealer Duo 1.5 Natural Beige Dimethicone STICK TOPICAL 20151201 OTC MONOGRAPH FINAL part347 The Saem International Co., Ltd. DIMETHICONE .66 g/8.5g N 20181231 70341-430_cf458de5-1dc3-4639-b5f2-e30afa8ec342 70341-430 HUMAN OTC DRUG Cover Perfection Tip Concealer 01 Clear Beige Titanium Dioxide CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE 1.52 g/6.5g N 20181231 70341-440_ab6648b6-6fc1-40c9-9acd-07050efb3476 70341-440 HUMAN OTC DRUG Cover Perfection Tip Concealer 02 Rich Beige Titanium Dioxide CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE 1.52 g/6.5g N 20181231 70341-450_402bc888-2fa4-4aa8-b83d-81be49d7b44c 70341-450 HUMAN OTC DRUG Cover Perfection Tip Concealer 1.5 Natural Beige Titanium Dioxide CREAM TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 The Saem International Co., Ltd. TITANIUM DIOXIDE 1.52 g/6.5g N 20181231 70341-460_cdaae4fb-b5da-4ac9-a35c-cf671f2f4e37 70341-460 HUMAN OTC DRUG Power Ampoule Whitening Dimethicone SOLUTION TOPICAL 20151201 OTC MONOGRAPH FINAL part347 The Saem International Co., Ltd. DIMETHICONE .72 g/40mL N 20181231 70341-470_bb781b6e-29c2-4f61-8bae-eadd46c26184 70341-470 HUMAN OTC DRUG Pure White Brightening Niacinamide EMULSION TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 2.8 g/140mL N 20181231 70341-480_930ace42-b51a-4b7c-9346-b0b685039bb5 70341-480 HUMAN OTC DRUG Pure White Brightening Essence Niacinamide CREAM TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 1.2 g/60mL N 20181231 70341-490_2eeeca77-d018-4358-ae22-777b500e732e 70341-490 HUMAN OTC DRUG Pure White Brightening Dimethicone CREAM TOPICAL 20151201 OTC MONOGRAPH FINAL part347 The Saem International Co., Ltd. DIMETHICONE 1.6 g/80mL N 20181231 70341-500_cb95f7f4-cdc6-44b1-981f-3478c9a8337b 70341-500 HUMAN OTC DRUG Pure White Brightening Toner Niacinamide LIQUID TOPICAL 20151201 UNAPPROVED DRUG OTHER The Saem International Co., Ltd. NIACINAMIDE 3.2 g/160mL N 20181231 70342-102_e99214c2-e15f-419c-92a5-cc21c90e0381 70342-102 HUMAN OTC DRUG SUN BATHE SUNSCREEN SPF 20 AVOBENZONE, OCTINOXATE, OCTOCRYLENE SOAP TOPICAL 20160523 OTC MONOGRAPH FINAL part352 BABY BUBBA ENTERPRISES INC AVOBENZONE; OCTINOXATE; OCTOCRYLENE 1.6; 5.2; 4.2 g/100g; g/100g; g/100g N 20181231 70344-001_d03a2040-5af8-4fc0-bbbe-825345c0782e 70344-001 HUMAN OTC DRUG Nixoderm Unguento salicylic acid OINTMENT TOPICAL 20160210 OTC MONOGRAPH FINAL part333D Laboratorios Incobra S.A. SALICYLIC ACID 2 g/100g E 20171231 70347-025_fab1df81-211f-444b-bddc-aa6f5fd5c94c 70347-025 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20180101 NDA NDA019962 Aralez Pharmaceuticals US Inc. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70347-035_8ddb7d22-8beb-4eba-81a5-814cfdecbfae 70347-035 HUMAN PRESCRIPTION DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20170805 NDA NDA022418 Aralez Pharmaceuticals US Inc. FENOFIBRIC ACID 35 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 70347-050_fab1df81-211f-444b-bddc-aa6f5fd5c94c 70347-050 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20180101 NDA NDA019962 Aralez Pharmaceuticals US Inc. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70347-081_40970d4a-a768-426a-8e8f-5f9b602acc52 70347-081 HUMAN PRESCRIPTION DRUG YOSPRALA Aspirin and Omeprazole TABLET, FILM COATED ORAL 20160914 NDA NDA205103 Aralez Pharmaceuticals Us Inc. ASPIRIN; OMEPRAZOLE 81; 40 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70347-100_fab1df81-211f-444b-bddc-aa6f5fd5c94c 70347-100 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20180101 NDA NDA019962 Aralez Pharmaceuticals US Inc. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70347-105_8ddb7d22-8beb-4eba-81a5-814cfdecbfae 70347-105 HUMAN PRESCRIPTION DRUG FIBRICOR Fenofibric Acid TABLET ORAL 20170805 NDA NDA022418 Aralez Pharmaceuticals US Inc. FENOFIBRIC ACID 105 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 70347-200_fab1df81-211f-444b-bddc-aa6f5fd5c94c 70347-200 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20180101 NDA NDA019962 Aralez Pharmaceuticals US Inc. METOPROLOL SUCCINATE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70347-208_708f0d47-bd22-483a-8925-c4795bd93f8b 70347-208 HUMAN PRESCRIPTION DRUG ZONTIVITY vorapaxar TABLET, FILM COATED ORAL 20140508 NDA NDA204886 Aralez Pharmaceuticals Us Inc. VORAPAXAR SULFATE 2.08 mg/1 Protease-activated Receptor-1 Antagonist [EPC],Protease-activated Receptor-1 Antagonists [MoA] N 20181231 70347-325_40970d4a-a768-426a-8e8f-5f9b602acc52 70347-325 HUMAN PRESCRIPTION DRUG YOSPRALA Aspirin and Omeprazole TABLET, FILM COATED ORAL 20160914 NDA NDA205103 Aralez Pharmaceuticals Us Inc. ASPIRIN; OMEPRAZOLE 325; 40 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70350-2600_b67f10b8-bc84-4d0c-9fd8-debb83c2b6c5 70350-2600 HUMAN PRESCRIPTION DRUG URE-K UREA CREAM TOPICAL 20160201 UNAPPROVED DRUG OTHER Solutech Pharmaceuticals LLC UREA 500 mg/g N 20181231 70350-2626_98fa3d4d-2079-4ff4-b43b-9848b8c87f23 70350-2626 HUMAN PRESCRIPTION DRUG RYNODERM UREA CREAM TOPICAL 20171027 UNAPPROVED DRUG OTHER SOLUTECH PHARMACEUTICALS LLC UREA 375 mg/g N 20181231 70350-5201_e8816c67-a9d7-4953-99e5-c2095aa10713 70350-5201 HUMAN PRESCRIPTION DRUG NOXIPAK FLUOCINOLONE ACETONIDE and UREA KIT 20171101 NDA AUTHORIZED GENERIC NDA015296 SOLUTECH PHARMACEUTICALS LLC N 20181231 70350-5218_1bdd2cf2-169b-4e44-a01b-122ee5661ae8 70350-5218 HUMAN PRESCRIPTION DRUG XILAPAK FLUOCINOLONE ACETONIDE KIT 20171101 NDA AUTHORIZED GENERIC NDA015296 SOLUTECH PHARMACEUTICALS LLC N 20181231 70351-101_3f8d518b-24a4-5d44-e054-00144ff8d46c 70351-101 HUMAN OTC DRUG ZYCAZIN Antiseptic Liquid Camphor, Phenol LIQUID TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part348 Axis Scientific LLC CAMPHOR (NATURAL); PHENOL 10.8; 4.7 mg/100mL; mg/100mL E 20171231 70353-0001_45ff8d4e-b7c6-4a54-95ef-53d5d638ef25 70353-0001 HUMAN OTC DRUG REBORNCELL AQUA RICH DIMETHICONE CREAM TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd DIMETHICONE .4 g/100mL E 20171231 70353-0002_5b53e487-71ab-44ef-9f41-54aebc762126 70353-0002 HUMAN OTC DRUG REBORNCELL AQUA RICH PURE SKIN ALLANTOIN LIQUID TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd ALLANTOIN 1 g/100mL E 20171231 70353-0003_3e5a3a0d-7da5-487f-88b4-231f6cc7bfec 70353-0003 HUMAN OTC DRUG REBORNCELL AQUA RICH SOFT ALLANTOIN LOTION TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd ALLANTOIN .1 g/100mL E 20171231 70353-0004_1f95628b-d0e6-422a-a1a6-84a06cdf8b75 70353-0004 HUMAN OTC DRUG REBORNCELL HAIR CLINIC DIMETHICONE SHAMPOO TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd DIMETHICONE 2 g/100mL E 20171231 70353-0005_f4680de0-f736-4b32-af49-f5655672ef4e 70353-0005 HUMAN OTC DRUG REBORNCELL M-CLINIC GLYCERIN SOAP TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd GLYCERIN 5 g/100g E 20171231 70353-0006_19b4ff8d-0e80-4ee7-9bae-fc5ab0c551df 70353-0006 HUMAN OTC DRUG REBORNCELL CLEANSING ALLANTOIN GEL TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd ALLANTOIN .05 g/100mL E 20171231 70353-0007_17586c98-3a1e-4e3c-9494-0f017389ae6f 70353-0007 HUMAN OTC DRUG Baby Creamy Sun Protector 100 DIMETHICONE CREAM TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd DIMETHICONE 3 g/100g E 20171231 70353-0008_2631855e-10ec-4235-8af0-12f20421a2b4 70353-0008 HUMAN OTC DRUG Baby Face and Body Creamy DIMETHICONE LOTION TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd DIMETHICONE .5 g/100mL E 20171231 70353-0009_ef4be18e-97ff-4d6d-8004-85ab5b78ef9b 70353-0009 HUMAN OTC DRUG Baby Head and Body Jelly Wash GLYCERIN LIQUID TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd GLYCERIN 10 g/100mL E 20171231 70353-0010_f339c574-150e-4557-a56d-899e4506800c 70353-0010 HUMAN OTC DRUG My Lovely Butts GLYCERIN LIQUID TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd GLYCERIN 2 g/100g E 20171231 70353-0011_14fbd120-5853-4dfb-a50e-1c98d5fb5377 70353-0011 HUMAN OTC DRUG Pororo Friends Moistful Mask Pack GLYCERIN LIQUID TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd GLYCERIN 7 g/100g E 20171231 70353-0012_bf238526-56f7-4b3a-b883-ac4919faffdb 70353-0012 HUMAN OTC DRUG Pororo Friends Tong Tong Firming Mask Pack GLYCERIN LIQUID TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd GLYCERIN 7 g/100g E 20171231 70353-0013_b0a902e4-687e-4277-905f-695011dd137b 70353-0013 HUMAN OTC DRUG Pororo Friends White Snow Mask Pack GLYCERIN LIQUID TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd GLYCERIN 7 g/100g E 20171231 70353-0014_24e23d3a-9db7-4588-b76f-8bce6d3b4188 70353-0014 HUMAN OTC DRUG Pororo Friends Smart Pore Guide Mask Pack GLYCERIN LIQUID TOPICAL 20151225 OTC MONOGRAPH FINAL part347 And Us Co., Ltd GLYCERIN 7 g/100g E 20171231 70354-0001_50d535aa-a615-4168-981c-4f7f351646c7 70354-0001 HUMAN OTC DRUG GYEOL DIMETHICONE SHAMPOO TOPICAL 20151218 OTC MONOGRAPH FINAL part347 MayimHayyim Bio Co., ltd. DIMETHICONE .6 g/100mL E 20171231 70355-001_28a46044-bdd1-581d-e054-00144ff8d46c 70355-001 HUMAN OTC DRUG PAIN RELIEF LIDOCAINE HYDROCHLORIDE,Menthol,METHYL SALICYLATE PATCH TOPICAL 20151230 OTC MONOGRAPH NOT FINAL part348 ZHEJIANG DONGYANG YINDA BIOLOGY CO., LTD LIDOCAINE; METHYL SALICYLATE; MENTHOL 4; 4; 5 g/100g; g/100g; g/100g E 20171231 70356-001_42b2fcc6-ec9f-543f-e054-00144ff8d46c 70356-001 HUMAN OTC DRUG Aftate Athlete Foot Cream Tolnaftate CREAM TOPICAL 20161201 OTC MONOGRAPH FINAL part333C Sabel Med LLC TOLNAFTATE 1 g/100g N 20181231 70356-050_306094fa-fbca-2b70-e054-00144ff88e88 70356-050 HUMAN OTC DRUG Athlete Foot Cream with Clotrimazole Clotrimazole CREAM TOPICAL 20160501 OTC MONOGRAPH FINAL part333C Sabel Med LLC CLOTRIMAZOLE 1 g/100g N 20181231 70356-051_2aa59dce-b108-006f-e054-00144ff88e88 70356-051 HUMAN OTC DRUG Jock Itch Cream with Clotrimazole Clotrimazole CREAM TOPICAL 20160501 OTC MONOGRAPH FINAL part333C Sabel Med LLC CLOTRIMAZOLE 1 g/100g N 20181231 70356-101_2f6e9a84-895d-492d-e054-00144ff8d46c 70356-101 HUMAN OTC DRUG Aftate Triple Antibiotic Triple Antibiotic Ointment OINTMENT TOPICAL 20160501 OTC MONOGRAPH FINAL part333B Sabel Med LLC POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC 5000; 3.5; 400 [iU]/g; mg/g; [iU]/g N 20181231 70356-125_2b390b06-cac4-4daa-e054-00144ff8d46c 70356-125 HUMAN OTC DRUG Aftate Bacitracin Zinc Bacitracin Zinc OINTMENT TOPICAL 20160501 OTC MONOGRAPH FINAL part333B Sabel Med LLC BACITRACIN ZINC 500 [iU]/g N 20181231 70356-201_2b390b06-cac6-4daa-e054-00144ff8d46c 70356-201 HUMAN OTC DRUG Aftate Hydrocortisone Cream Hydrocortisone Cream CREAM TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part348 Sabel Med LLC HYDROCORTISONE ACETATE 1 g/100g N 20181231 70356-326_2fd39d46-98e5-42a7-e054-00144ff88e88 70356-326 HUMAN OTC DRUG Aftate Zinc Oxide Zinc Oxide OINTMENT TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part348 Sabel Med LLC ZINC OXIDE .2 g/g N 20181231 70359-4101_43a42dcc-1c9f-3881-e054-00144ff8d46c 70359-4101 HUMAN OTC DRUG Buttiezzz Daily Zinc Oxide SPRAY TOPICAL 20160119 OTC MONOGRAPH FINAL part347 Fortunique B.V. ZINC OXIDE 4 g/100g E 20171231 70359-4102_43a476ab-fac9-4302-e054-00144ff8d46c 70359-4102 HUMAN OTC DRUG Buttiezzz Intense Zinc Oxide SPRAY TOPICAL 20160120 OTC MONOGRAPH FINAL part347 Fortunique B.V. ZINC OXIDE 10 g/100g E 20171231 70359-4106_43a40622-a711-2d7b-e054-00144ff8d46c 70359-4106 HUMAN OTC DRUG Poxiezzz Menthol, Zinc Oxide SPRAY TOPICAL 20160121 OTC MONOGRAPH FINAL part347 Fortunique B.V. MENTHOL, UNSPECIFIED FORM; ZINC OXIDE 1; 4 g/100g; g/100g E 20171231 70359-4107_43a476ab-fad8-4302-e054-00144ff8d46c 70359-4107 HUMAN OTC DRUG Breathiezzz Camphor,Menthol OIL TOPICAL 20160121 OTC MONOGRAPH FINAL part341 Fortunique B.V. CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM 5; 2.75 g/100g; g/100g E 20171231 70362-720_6270b2d8-ff42-0e32-e053-2a91aa0aadb2 70362-720 HUMAN PRESCRIPTION DRUG PANLOR Acetaminophen, Caffeine and Dihydrocodeine Bitartrate TABLET ORAL 20180109 ANDA ANDA204209 Skylar Laboratories, LLC ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 325; 30; 16 mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 70362-721_2acd3109-5c89-4869-e054-00144ff8d46c 70362-721 HUMAN PRESCRIPTION DRUG Butalbital And Acetaminophen butalbital and acetaminophen TABLET ORAL 20151204 ANDA ANDA203484 Skylar Laboratories, LLC BUTALBITAL; ACETAMINOPHEN 50; 325 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] E 20171231 70362-722_2acd3109-5c89-4869-e054-00144ff8d46c 70362-722 HUMAN PRESCRIPTION DRUG ALLZITAL butalbital and acetaminophen TABLET ORAL 20151204 ANDA ANDA203484 Skylar Laboratories, LLC BUTALBITAL; ACETAMINOPHEN 25; 325 mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient] E 20171231 70363-007_1ff2023b-b1c7-40e3-a71e-d5ca4b7d70bd 70363-007 HUMAN PRESCRIPTION DRUG Aktipak erythromycin and benzoyl peroxide GEL TOPICAL 20170410 NDA NDA050769 Cutanea Life Sciences, Inc. ERYTHROMYCIN; BENZOYL PEROXIDE 30; 50 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70365-001_eba3afd5-f152-45c8-a5a2-dc28593abd7e 70365-001 HUMAN OTC DRUG Aubio Life Sciences Lip Allantoin and Lidocaine CREAM TOPICAL 20160228 OTC MONOGRAPH FINAL part347 Aubio Life Sciences LLC ALLANTOIN; LIDOCAINE 5; 5 mg/g; mg/g E 20171231 70365-002_1079236a-c2c2-450f-bf61-7960780394c4 70365-002 HUMAN OTC DRUG Aubio Life Sciences Lip Homosalate, Avobenzone, Octisalate and Octocrylene LIPSTICK TOPICAL 20160228 OTC MONOGRAPH NOT FINAL part352 Aubio Life Sciences LLC HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 150; 30; 30; 27 mg/g; mg/g; mg/g; mg/g E 20171231 70370-1040_70542128-491f-41c9-8ec2-fd228ecfbc5c 70370-1040 HUMAN PRESCRIPTION DRUG INGREZZA Valbenazine CAPSULE ORAL 20170420 NDA NDA209241 Neurocrine Biosciences, Inc. VALBENAZINE 40 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20181231 70370-1080_70542128-491f-41c9-8ec2-fd228ecfbc5c 70370-1080 HUMAN PRESCRIPTION DRUG INGREZZA Valbenazine CAPSULE ORAL 20171004 NDA NDA209241 Neurocrine Biosciences, Inc. VALBENAZINE 80 mg/1 Vesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA] N 20181231 70372-722_47f4f989-fb3a-6576-e054-00144ff8d46c 70372-722 HUMAN OTC DRUG LidoSport Pain Relief LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20151225 OTC MONOGRAPH NOT FINAL part348 Centura Pharmaceuticals, Inc LIDOCAINE HYDROCHLORIDE 40 mg/mL N 20181231 70372-723_47f4f989-fb2a-6576-e054-00144ff8d46c 70372-723 HUMAN OTC DRUG LidoPlus Pain Relief LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20151225 OTC MONOGRAPH NOT FINAL part348 Centura Pharmaceuticals, Inc LIDOCAINE HYDROCHLORIDE 40 mg/mL N 20181231 70372-724_2eeaa595-5afb-589f-e054-00144ff8d46c 70372-724 HUMAN OTC DRUG LidoPlus Pain Relief Patch LIDOCAINE, MENTHOL PATCH TOPICAL 20160325 OTC MONOGRAPH NOT FINAL part348 CENTURA PHARMACEUTICALS INC LIDOCAINE; MENTHOL 600; 150 mg/1; mg/1 E 20171231 70372-725_2df6a492-d504-2435-e054-00144ff8d46c 70372-725 HUMAN OTC DRUG LidoSport Pain Relief Patch LIDOCAINE, MENTHOL PATCH TOPICAL 20160329 OTC MONOGRAPH NOT FINAL part348 CENTURA PHARMACEUTICALS INC MENTHOL; LIDOCAINE 150; 600 mg/1; mg/1 E 20171231 70372-726_34385375-1c3e-5ecd-e054-00144ff8d46c 70372-726 HUMAN OTC DRUG PerioRinse DYCLONINE RINSE DENTAL; ORAL; TOPICAL; TRANSMUCOSAL 20160616 OTC MONOGRAPH NOT FINAL part356 CENTURA PHARMACEUTICALS INC DYCLONINE HYDROCHLORIDE .1 g/100mL E 20171231 70372-727_3eea2171-850c-4045-e054-00144ff8d46c 70372-727 HUMAN OTC DRUG BLT 1 BENZOCAINE OINTMENT TOPICAL 20161015 OTC MONOGRAPH NOT FINAL part348 CENTURA PHARMACEUTICALS INC BENZOCAINE 20 g/100g N 20181231 70372-728_41dc85ec-d79c-0a32-e054-00144ff8d46c 70372-728 HUMAN OTC DRUG BLT 2 LIDOCAINE HCL OINTMENT TOPICAL 20161121 OTC MONOGRAPH NOT FINAL part348 CENTURA PHARMACEUTICALS INC LIDOCAINE HYDROCHLORIDE 4 g/100g N 20181231 70372-729_401a0d22-1182-02ac-e054-00144ff88e88 70372-729 HUMAN OTC DRUG BLT 3 TETRACAINE OINTMENT TOPICAL 20161030 OTC MONOGRAPH NOT FINAL part348 CENTURA PHARMACEUTICALS INC TETRACAINE 2 g/100g N 20181231 70373-0001_8e0b98ec-ab6a-42af-a71c-6cbfc9ac7544 70373-0001 HUMAN OTC DRUG HUCORD Anti-aging Babycell DIMETHICONE CREAM TOPICAL 20151229 OTC MONOGRAPH FINAL part347 Hucord Co., Ltd. DIMETHICONE .5 g/100g N 20181231 70373-0002_8cdf37ea-eef6-40ea-8313-c2e327659885 70373-0002 HUMAN OTC DRUG HUCORD Anti-aging Babycell Serum DIMETHICONE LIQUID TOPICAL 20151229 OTC MONOGRAPH FINAL part347 Hucord Co., Ltd. DIMETHICONE 3 g/100mL N 20181231 70373-0003_da58dc0b-735c-4461-831f-2b4f69f2e2cc 70373-0003 HUMAN OTC DRUG HUCORD HSCM-100 Ampoule INSULIN-LIKE GROWTH FACTOR-2 LIQUID TOPICAL 20151229 UNAPPROVED DRUG OTHER Hucord Co., Ltd. INSULIN-LIKE GROWTH FACTOR-2 .0000633 g/100mL N 20181231 70373-0004_371598a7-f72c-112c-e054-00144ff88e88 70373-0004 HUMAN OTC DRUG MORAN GLYCERIN GEL VAGINAL 20160701 UNAPPROVED DRUG OTHER Hucord Co., Ltd. GLYCERIN 4 g/100g N 20181231 70374-0001_34b72745-b225-463f-b9d8-e26ce1fda5db 70374-0001 HUMAN OTC DRUG Lavietox B Project Re Set Firming Essence GLYCERIN LIQUID TOPICAL 20151225 OTC MONOGRAPH FINAL part347 Aqualex GLYCERIN 2 g/100mL N 20181231 70374-0002_20a0c71e-76cc-498d-be53-2d966fe1760a 70374-0002 HUMAN OTC DRUG Lavietox D Project Re Set Purifying Softner DIMETHICONE LIQUID TOPICAL 20151225 OTC MONOGRAPH FINAL part347 Aqualex DIMETHICONE 5 g/100mL N 20181231 70376-001_36531b8b-8aa9-44d2-af55-a24aed00abec 70376-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20140304 NDA NDA205849 Metro Aire LTD OXYGEN 990 L/L N 20181231 70377-001_e2696f22-3e73-8d68-16fe-2e5bb7b9a111 70377-001 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20151217 ANDA ANDA078034 Biocon Pharma Inc, SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70377-002_e2696f22-3e73-8d68-16fe-2e5bb7b9a111 70377-002 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20151217 ANDA ANDA078034 Biocon Pharma Inc, SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70377-003_e2696f22-3e73-8d68-16fe-2e5bb7b9a111 70377-003 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20151217 ANDA ANDA078034 Biocon Pharma Inc, SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70377-004_e2696f22-3e73-8d68-16fe-2e5bb7b9a111 70377-004 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20151217 ANDA ANDA078034 Biocon Pharma Inc, SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70377-005_e2696f22-3e73-8d68-16fe-2e5bb7b9a111 70377-005 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20151217 ANDA ANDA078034 Biocon Pharma Inc, SIMVASTATIN 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70377-006_092e4f86-e204-a66c-9fa3-5237de993942 70377-006 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA207752 Biocon Pharma Inc ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70377-007_092e4f86-e204-a66c-9fa3-5237de993942 70377-007 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA207752 Biocon Pharma Inc ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70377-008_092e4f86-e204-a66c-9fa3-5237de993942 70377-008 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA207752 Biocon Pharma Inc ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70377-009_092e4f86-e204-a66c-9fa3-5237de993942 70377-009 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA207752 Biocon Pharma Inc ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70378-001_e8a3b54b-9957-46b5-8cf6-cbb85699cbd3 70378-001 HUMAN OTC DRUG Artemisia No Smoking WORMWOOD INHALANT TOPICAL 20160107 UNAPPROVED DRUG OTHER KOREA STOP Smoking science CO., LTD. WORMWOOD 1 g/g E 20171231 70378-004_4d7e5426-420d-3ed7-e054-00144ff88e88 70378-004 HUMAN OTC DRUG SSOOK GUN HYANG CHO(hazelnut) WORMWOOD INHALANT TOPICAL 20160107 UNAPPROVED DRUG OTHER KOREA STOP Smoking science CO., LTD. WORMWOOD 1 g/g N 20181231 70378-005_4d7e7c84-843d-16de-e054-00144ff8d46c 70378-005 HUMAN OTC DRUG SSOOK GUN HYANG CHO(peppermint) WORMWOOD INHALANT TOPICAL 20160107 UNAPPROVED DRUG OTHER KOREA STOP Smoking science CO., LTD. WORMWOOD 1 g/g N 20181231 70379-101_90e0128d-5b6e-4522-9d64-9b8a3cb5023f 70379-101 HUMAN OTC DRUG PUNCHGUNK MENTHOL LOTION TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part348 Punch Gunk MENTHOL 3 g/100mL E 20171231 70380-010_a0d76221-22d5-4b9d-bdb5-2b2501b27122 70380-010 HUMAN OTC DRUG EHP Cleansing Cyclomethicone OIL TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA CYCLOMETHICONE 15 g/150mL E 20171231 70380-020_f651f644-fc73-4eac-aa40-b5073fbd5bfa 70380-020 HUMAN OTC DRUG AC Clear Sheet Mask Glycerin PATCH TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 1.84 g/23mL E 20171231 70380-030_b0618f01-b011-4aa4-8262-e80e5d4fb55a 70380-030 HUMAN OTC DRUG Water Balance Sheet Mask Glycerin PATCH TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 2.3 g/23mL E 20171231 70380-040_30f78c28-b1a2-440e-8d26-c83f4522ef6d 70380-040 HUMAN OTC DRUG Wrinkle Repair Sheet Mask Glycerin PATCH TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 2.3 g/23mL E 20171231 70380-050_b88ba00d-8a11-4855-95cd-5f6d3d28bac2 70380-050 HUMAN OTC DRUG Daily Whitening Care Sheet Mask Niacinamide PATCH TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA NIACINAMIDE .46 g/23mL E 20171231 70380-060_653d0667-2291-468b-b16a-42950008268f 70380-060 HUMAN OTC DRUG Origin Horse Sheet Mask Glycerin PATCH TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 1.84 g/23mL E 20171231 70380-070_7898579a-57a4-45d2-9a52-127cd6a4f487 70380-070 HUMAN OTC DRUG AC Control Serum Allantoin CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA ALLANTOIN .1 g/50mL E 20171231 70380-080_2cda78b6-439f-4281-8d3c-a035c546c4a2 70380-080 HUMAN OTC DRUG Aloe Soothing Glycerin GEL TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 16 g/200mL E 20171231 70380-090_f7111da2-d297-4e97-a58d-a74acd346098 70380-090 HUMAN OTC DRUG Anti Wrinkle Effect Ample Glycerin SOLUTION TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 2.8 g/35mL E 20171231 70380-100_40a735ca-c009-476b-a953-9c00ecb0da5e 70380-100 HUMAN OTC DRUG Anti Wrinkle effect Glycerin CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 5 g/50mL E 20171231 70380-110_e6f146a2-055a-41a8-b2da-fd057160d804 70380-110 HUMAN OTC DRUG Anti Wrinkle Effect Eye Glycerin CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 1.2 g/20mL E 20171231 70380-120_e91ea7dc-c173-4c15-9ae5-a450951b0832 70380-120 HUMAN OTC DRUG Anti Wrinkle Hand Essence Glycerin CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 3 g/30mL E 20171231 70380-130_b89e4291-94d8-4335-879a-2a64a4ce304e 70380-130 HUMAN OTC DRUG Apple Bubble Glycerin INJECTABLE FOAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 12 g/120mL E 20171231 70380-140_a0b521a7-d2a5-4143-949a-1894d2d67252 70380-140 HUMAN OTC DRUG BP CYCLOMETHICONE 5 CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA CYCLOMETHICONE 5 3.6 g/30mL E 20171231 70380-150_602a1df3-62d8-43c7-82e1-0a8451ae3b9a 70380-150 HUMAN OTC DRUG Camelia Facial CAMELLIA JAPONICA SEED OIL TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA CAMELLIA JAPONICA SEED OIL 34.8 g/35mL E 20171231 70380-160_9882697b-8524-4c82-bfc7-563c9f2656a6 70380-160 HUMAN OTC DRUG Daily Care Sun Octinoxate, Titanium Dioxide CREAM TOPICAL 20160102 OTC MONOGRAPH NOT FINAL part352 MIGUHARA OCTINOXATE; TITANIUM DIOXIDE 2.5; .56 g/50mL; g/50mL E 20171231 70380-170_2db9af78-16fc-4e63-a2bf-8e2fd1b8a055 70380-170 HUMAN OTC DRUG Dead Skin Perfect Cleanser Glycerin LIQUID TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 26 g/200mL E 20171231 70380-180_d14531eb-b553-4b1b-947f-2453de243d45 70380-180 HUMAN OTC DRUG EGF Crystal 10 ppm Glycerin CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 1 g/25mL E 20171231 70380-190_bab531f0-6347-419d-b707-a00cf1cadcee 70380-190 HUMAN OTC DRUG Hyalucollagen Essence Glycerin CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 4 g/50mL E 20171231 70380-200_d62430db-fab7-4218-a2d0-3a08459ba965 70380-200 HUMAN OTC DRUG Hyalucollagen Moisture Glycerin EMULSION TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 12 g/120mL E 20171231 70380-210_142dce99-36db-4984-893b-17b6d7a7fb94 70380-210 HUMAN OTC DRUG Hyalucollagen Moisture Glycerin LOTION TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 10.5 g/150mL E 20171231 70380-220_8d4660fd-0014-4dea-97ff-49e63ec9922f 70380-220 HUMAN OTC DRUG Hyalucollagen Moisture Skin Glycerin SPRAY TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 12 g/150mL E 20171231 70380-230_e062410c-8793-4b5e-9f7d-2b3098f8eb68 70380-230 HUMAN OTC DRUG Hyalucollagen Moisture Toner Glycerin SPRAY TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 7.2 g/120mL E 20171231 70380-240_1c457a31-3d70-4ab6-b233-a70f5e2c8edc 70380-240 HUMAN OTC DRUG Hyalucollagen Moisturizer Normal and dry skin Glycerin CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 2.5 g/50mL E 20171231 70380-250_297c937e-74ef-4fb1-bf77-55ce663f8d32 70380-250 HUMAN OTC DRUG Hyalucollagen Moisturizer combination skin Glycerin CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 3.5 g/50mL E 20171231 70380-260_f2996777-b504-4e69-b34d-1c8cb55c1ff3 70380-260 HUMAN OTC DRUG Moisture Essence Mist Glycerin SPRAY TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 4.8 g/80mL E 20171231 70380-270_45bc48f0-ae10-443d-84bb-0f156c49df13 70380-270 HUMAN OTC DRUG Moisturizing Body Glycerin LOTION TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 15 g/300mL E 20171231 70380-280_a6282be3-92ec-4236-94cd-90736f0cf7da 70380-280 HUMAN OTC DRUG Pore Blackhead Clear Mask Witch Hazel PATCH TOPICAL 20160102 OTC MONOGRAPH FINAL part347 MIGUHARA WITCH HAZEL .02 g/101 E 20171231 70380-290_7a60c9f0-7d26-439b-a5c7-8870a720127d 70380-290 HUMAN OTC DRUG Pore Blackhead Tightening Mask Witch Hazel PATCH TOPICAL 20160102 OTC MONOGRAPH FINAL part347 MIGUHARA WITCH HAZEL .03 g/101 E 20171231 70380-300_cb037b5c-e2ac-4c04-9845-c881a5569e0b 70380-300 HUMAN OTC DRUG Refining Pore Clear Pack Glycerin GEL TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 15 g/150g E 20171231 70380-310_9ae59261-d5c7-452c-b292-2ccbd7a6a011 70380-310 HUMAN OTC DRUG Scar Serum Glycerin CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA GLYCERIN 2.5 g/50mL E 20171231 70380-320_356500b9-605e-4272-bcae-116d0b581114 70380-320 HUMAN OTC DRUG Ultra Whitening Ample Niacinamide CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA NIACINAMIDE .7 g/35mL E 20171231 70380-330_051a3b49-2bb3-487a-af2e-3eccdc94c42e 70380-330 HUMAN OTC DRUG Ultra Whitening First Essence Niacinamide CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA NIACINAMIDE 2.4 g/120mL E 20171231 70380-340_ab68ef0b-85b0-4c9d-882b-8edbd34efdb9 70380-340 HUMAN OTC DRUG Ultra Whitening Niacinamide CREAM TOPICAL 20160102 UNAPPROVED DRUG OTHER MIGUHARA NIACINAMIDE 1 g/50mL E 20171231 70381-001_618464e6-e070-859a-e053-2a91aa0ac930 70381-001 HUMAN OTC DRUG Oil Control Mattifier SPF 15 ENSULIZOLE, OCTINOXATE, OCTINOXATE CREAM TOPICAL 20151231 OTC MONOGRAPH NOT FINAL part352 Murad Inc ENSULIZOLE; OCTINOXATE; ZINC OXIDE 10; 75; 30 mg/mL; mg/mL; mg/mL N 20181231 70384-100_772b1bda-1b91-47c3-aead-b2d1d4a328f0 70384-100 HUMAN OTC DRUG Defend Hydrating Broad Spectrum SPF 15 SPF 15 Sunscreen CREAM TOPICAL 20160407 OTC MONOGRAPH FINAL part352 Profile 4 Men LLC HOMOSALATE; AVOBENZONE; OCTISALATE 6; 2.25; 3.75 mg/75mL; mg/75mL; mg/75mL E 20171231 70385-2003_4cc59056-a5a9-696d-e054-00144ff88e88 70385-2003 HUMAN PRESCRIPTION DRUG Ammonia Inhalants Ammonia Inhalants INHALANT RESPIRATORY (INHALATION) 19760214 UNAPPROVED DRUG OTHER Sina Health Inc AMMONIA .045 g/.3mL N 20181231 70385-2005_2d5393e3-335f-6133-e054-00144ff88e88 70385-2005 HUMAN OTC DRUG Aspirin Aspirin TABLET, FILM COATED ORAL 20110725 OTC MONOGRAPH FINAL part343 Sina Health Inc ASPIRIN 325 mg/1 N 20181231 70385-2007_2d51aae4-d1db-22bc-e054-00144ff88e88 70385-2007 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 19721127 ANDA ANDA080817 Sina Health Inc DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 70385-2008_2d524e06-907d-400a-e054-00144ff88e88 70385-2008 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20050908 UNAPPROVED DRUG OTHER Sina Health Inc EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 70385-2009_2d4165c3-16e9-5af8-e054-00144ff8d46c 70385-2009 HUMAN PRESCRIPTION DRUG epinephrine epinephrine INJECTION SUBCUTANEOUS 20100401 NDA AUTHORIZED GENERIC NDA020800 Sina Health Inc EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 70385-2013_2d53f70f-3c6e-6934-e054-00144ff88e88 70385-2013 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride NALOXONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 19870107 ANDA ANDA070256 Sina Health Inc NALOXONE HYDROCHLORIDE .4 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 70385-2014_2d4165c3-169e-5af8-e054-00144ff8d46c 70385-2014 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20000501 NDA NDA021134 Sina Health Inc NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 70385-2016_4cc6480c-df7e-0a78-e054-00144ff88e88 70385-2016 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 19590402 NDA NDA011856 Sina Health Inc METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70385-2017_4cc59056-a5af-696d-e054-00144ff88e88 70385-2017 HUMAN PRESCRIPTION DRUG epinephrine epinephrine INJECTION SUBCUTANEOUS 20100401 NDA AUTHORIZED GENERIC NDA020800 Sina Health Inc EPINEPHRINE .15 mg/.15mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 70385-2018_4cc7cc3d-aa2d-49c4-e054-00144ff8d46c 70385-2018 HUMAN PRESCRIPTION DRUG NITROGLYCERIN nitroglycerin TABLET, ORALLY DISINTEGRATING SUBLINGUAL 20160826 NDA AUTHORIZED GENERIC NDA021134 Sina Health Inc NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 70385-2021_4cc7f2af-1ebb-3d01-e054-00144ff88e88 70385-2021 HUMAN PRESCRIPTION DRUG Flumazenil flumazenil INJECTION, SOLUTION INTRAVENOUS 20070101 ANDA ANDA078527 Sina Health Inc FLUMAZENIL .1 mg/mL Benzodiazepine Antagonist [EPC] N 20181231 70391-233_588bf311-b6e0-d6f1-e053-2a91aa0ae0f8 70391-233 HUMAN OTC DRUG Guaifenesin Extended-Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170906 ANDA ANDA209215 Guardian Pharmaceuticals, LLC GUAIFENESIN 600 mg/1 N 20181231 70391-234_588bf311-b6e0-d6f1-e053-2a91aa0ae0f8 70391-234 HUMAN OTC DRUG Guaifenesin Extended-Release Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170906 ANDA ANDA209215 Guardian Pharmaceuticals, LLC GUAIFENESIN 1200 mg/1 N 20181231 70392-010_2963dbcd-09dc-6c51-e054-00144ff8d46c 70392-010 HUMAN OTC DRUG SPF 30 Stay Put Sunscreen HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20160115 OTC MONOGRAPH NOT FINAL part352 Sawyer Products HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 100; 75; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 70392-011_2963dbcd-09c7-6c51-e054-00144ff8d46c 70392-011 HUMAN OTC DRUG SPF 30 Stay Put Sunscreen HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20160115 OTC MONOGRAPH NOT FINAL part352 Sawyer Products HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 100; 75; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 70392-012_2963dbcd-09f1-6c51-e054-00144ff8d46c 70392-012 HUMAN OTC DRUG SPF 30 Stay Put Sunscreen HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part352 Sawyer Products HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE 100; 75; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 70392-013_2963dbcd-09b8-6c51-e054-00144ff8d46c 70392-013 HUMAN OTC DRUG SPF 50 Stay Put Sunscreen OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20160115 OTC MONOGRAPH NOT FINAL part352 Sawyer Products OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 50; 60; 26 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 70392-014_2963172a-1d8b-20e5-e054-00144ff88e88 70392-014 HUMAN OTC DRUG SPF 50 Stay Put Sunscreen OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20160114 OTC MONOGRAPH NOT FINAL part352 Sawyer Products OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 50; 60; 26 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 70392-015_2963dbcd-09a9-6c51-e054-00144ff8d46c 70392-015 HUMAN OTC DRUG SPF 50 Stay Put Sunscreen OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20160115 OTC MONOGRAPH NOT FINAL part352 Sawyer Products OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 50; 60; 26 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 70393-400_c1415d91-6175-47fc-ac22-09a56256ca59 70393-400 HUMAN OTC DRUG CareTouch Alcohol Prep Pad isopropyl alcohol SWAB TOPICAL 20160108 OTC MONOGRAPH NOT FINAL part333A Future Diagnostics Llc ISOPROPYL ALCOHOL .7 mL/1 N 20181231 70393-415_5da843ae-3e5b-4c00-abce-bb1b979562fc 70393-415 HUMAN OTC DRUG CareTouch Ethyl alcohol CLOTH TOPICAL 20170523 OTC MONOGRAPH NOT FINAL part333A Future Diagnostics Llc ALCOHOL .62 mL/mL N 20181231 70397-2016_289542c1-1348-3b43-e054-00144ff8d46c 70397-2016 HUMAN OTC DRUG Zebs broad spectrum sunscreen Zinc Oxide LOTION TOPICAL 20160208 OTC MONOGRAPH NOT FINAL part352 New Era Naturals LLC ZINC OXIDE 8 g/100g E 20171231 70399-102_260324cf-7851-4d90-ab35-5f71bc5104b0 70399-102 HUMAN PRESCRIPTION DRUG DILAUDID Hydromorphone Hydrochloride TABLET ORAL 20170820 ANDA ANDA076723 V1 Pharma Llc HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 70401-150_38c316ec-0b8d-4f6f-8b24-bc9901508b13 70401-150 HUMAN OTC DRUG Zoom Wipes Benzalkonium chloride SWAB TOPICAL 20160520 OTC MONOGRAPH NOT FINAL part333A ZOOM PRODUCTS LLC BENZALKONIUM CHLORIDE .13 g/100g N 20181231 70402-004_6191106d-2f5a-26c0-e053-2a91aa0a5e78 70402-004 HUMAN OTC DRUG International First Amenity Kit ETHYL ALCOHOL, sodium fluoride KIT 20160201 20201231 OTC MONOGRAPH NOT FINAL part333E BUZZ PRODUCTS (HK) CO. LIMITED N 20191231 70402-005_6190fb11-887f-24c2-e053-2991aa0a44ed 70402-005 HUMAN OTC DRUG International Business Amenity Kit Sodium Fluoride PASTE, DENTIFRICE DENTAL 20160201 OTC MONOGRAPH FINAL part355 BUZZ PRODUCTS (HK) CO. LIMITED SODIUM FLUORIDE 1.5 mg/g N 20181231 70402-006_61911866-728a-8cf2-e053-2a91aa0a637d 70402-006 HUMAN OTC DRUG Transcon First Amenity Kit Sodium Fluoride PASTE, DENTIFRICE DENTAL 20160201 OTC MONOGRAPH FINAL part355 BUZZ PRODUCTS (HK) CO. LIMITED SODIUM FLUORIDE 1.5 mg/g N 20181231 70403-921_62ca51d8-3367-43b3-be0d-64f04c8474c6 70403-921 HUMAN OTC DRUG ARTIFICIAL TEARS Carboxymethylcellulose Sodium SOLUTION/ DROPS OPHTHALMIC 20180122 OTC MONOGRAPH FINAL part349 Aru Pharma Inc. CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 10 mg/mL N 20191231 70403-922_27f42a07-0493-4f19-ac01-6cb48d91c210 70403-922 HUMAN OTC DRUG HYDROCORTISONE MAXIMUM STRENGTH Hydrocortisone OINTMENT TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part348 Aru Pharma Inc. HYDROCORTISONE 10 mg/g N 20191231 70403-923_504a71a7-bb69-437d-9578-bc3fa997dff4 70403-923 HUMAN OTC DRUG HYDROCORTISONE MAXIMUM STRENGTH Hydrocortisone CREAM TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part348 Aru Pharma Inc. HYDROCORTISONE 10 mg/g N 20191231 70403-924_7f5fa6b8-2f1d-4c30-806e-19483465c2af 70403-924 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM TOPICAL 20180101 OTC MONOGRAPH FINAL part333C Aru Pharma Inc. MICONAZOLE NITRATE 20 mg/g N 20191231 70403-925_645746e2-ecb9-403c-a5ee-8fc8cf604d62 70403-925 HUMAN OTC DRUG CLOTRIMAZOLE ANTIFUNGAL Clotrimazole CREAM TOPICAL 20180101 OTC MONOGRAPH FINAL part333C Aru Pharma Inc. CLOTRIMAZOLE 10 mg/g N 20191231 70406-010_7eb40ff3-ee72-4d3f-bd69-f3d5f30cf10c 70406-010 HUMAN OTC DRUG ALEGRIA Sodium Monofluorophosphate PASTE, DENTIFRICE ORAL 20160102 OTC MONOGRAPH FINAL part355 Seowangmo corporation SODIUM MONOFLUOROPHOSPHATE .98 g/130g E 20171231 70406-020_94922bb3-ae80-4c43-aadf-8aaee21bd67b 70406-020 HUMAN OTC DRUG Alegria Neo SILICON DIOXIDE, Allantoin PASTE, DENTIFRICE TOPICAL 20171001 UNAPPROVED DRUG OTHER Seowangmo Corporation SILICON DIOXIDE; ALLANTOIN 2.8; .008 g/20g; g/20g N 20181231 70408-141_67019eb5-1f26-417d-817f-586331f13231 70408-141 HUMAN PRESCRIPTION DRUG RANITIDINE RANITIDINE SYRUP ORAL 20111003 ANDA ANDA091091 Nostrum Laboratories, Inc. RANITIDINE HYDROCHLORIDE 15 mg/mL Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70408-146_c6c7a979-42b6-4805-a90a-6120f7656f00 70408-146 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SOLUTION ORAL 20090313 ANDA ANDA040891 Nostrum Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70408-185_46909f94-e911-4d35-9e60-d52dcd7fdcd1 70408-185 HUMAN PRESCRIPTION DRUG promethazine hydrochloride and codeine phosphate promethazine hydrochloride and codeine phosphate SOLUTION ORAL 20100317 ANDA ANDA090180 Nostrum Laboratories, Inc. PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE 6.25; 10 mg/5mL; mg/5mL Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CV N 20181231 70408-239_0de14d99-1089-4685-b13c-a6abd3a2ec9f 70408-239 HUMAN PRESCRIPTION DRUG NITROFURANTOIN NITROFURANTOIN SUSPENSION ORAL 20120304 ANDA ANDA201355 Nostrum Laboratories, Inc. NITROFURANTOIN 25 mg/5mL Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 70408-358_8a1db324-0993-43fb-9a30-ad59d191dce8 70408-358 HUMAN PRESCRIPTION DRUG Morphine Sulfate Oral Solution Morphine Sulfate Oral Solution SOLUTION ORAL 20140205 ANDA ANDA201011 Nostrum Laboratories, Inc. MORPHINE SULFATE 10 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 70408-359_8a1db324-0993-43fb-9a30-ad59d191dce8 70408-359 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate SOLUTION ORAL 20140205 ANDA ANDA201011 Nostrum Laboratories, Inc. MORPHINE SULFATE 20 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 70408-368_eff96619-e06a-4fe4-8982-1e0826155f67 70408-368 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20160106 ANDA ANDA201466 Nostrum Laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 10 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 70408-369_eff96619-e06a-4fe4-8982-1e0826155f67 70408-369 HUMAN PRESCRIPTION DRUG Methylphenidate Hydrochloride Methylphenidate Hydrochloride SOLUTION ORAL 20160106 ANDA ANDA201466 Nostrum Laboratories, Inc. METHYLPHENIDATE HYDROCHLORIDE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 70408-644_290d1a63-e9a4-4d97-9d20-2f9c937d8661 70408-644 HUMAN PRESCRIPTION DRUG ELIXOPHYLLIN THEOPHYLLINE ANHYDROUS LIQUID ORAL 20091001 ANDA ANDA085186 Nostrum Laboratories, Inc. THEOPHYLLINE ANHYDROUS 80 mg/15mL Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20181231 70408-746_638661fd-c068-4c88-bfd6-594e37e5e709 70408-746 HUMAN PRESCRIPTION DRUG Morphine Sulfate Oral Solution CII Morphine Sulfate SOLUTION ORAL 20161006 ANDA ANDA204053 Nostrum Laboratories, Inc. MORPHINE SULFATE 100 mg/5mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 70410-001_2ae4d1b9-8a58-08cd-e054-00144ff88e88 70410-001 HUMAN OTC DRUG Natural Epsom Salt magnesium sulfate POWDER TOPICAL 20160126 OTC MONOGRAPH NOT FINAL part334 Point Guard Marketing Inc. MAGNESIUM SULFATE 10 g/10g E 20171231 70410-002_2a46e6fc-c78a-4a1e-e054-00144ff8d46c 70410-002 HUMAN OTC DRUG Natural Epsom Salt Lavender magnesium sulfate POWDER TOPICAL 20160126 OTC MONOGRAPH NOT FINAL part334 Point Guard Marketing Inc. MAGNESIUM SULFATE 10 g/10g E 20171231 70410-003_2a471d7a-d6cf-5773-e054-00144ff8d46c 70410-003 HUMAN OTC DRUG Eucalyptus Scented Natural Epsom Salt magnesium sulfate POWDER TOPICAL 20160126 OTC MONOGRAPH NOT FINAL part334 Point Guard Marketing Inc. MAGNESIUM SULFATE 10 g/10g E 20171231 70410-004_2ae3e554-00fb-628c-e054-00144ff88e88 70410-004 HUMAN OTC DRUG Green Tea Chamomile Natural Epsom Salt magnesium sulfate POWDER TOPICAL 20160126 OTC MONOGRAPH NOT FINAL part334 Point Guard Marketing Inc. MAGNESIUM SULFATE 10 g/10g E 20171231 70410-005_2a819216-e760-14a6-e054-00144ff88e88 70410-005 HUMAN OTC DRUG Spearmint and Menthol scented Natural Epsom Salt magnesium sulfate POWDER TOPICAL 20160127 OTC MONOGRAPH NOT FINAL part334 Point Guard Marketing Inc. MAGNESIUM SULFATE 10 g/10g E 20171231 70410-006_2a52e001-c1be-004a-e054-00144ff8d46c 70410-006 HUMAN OTC DRUG Natural Epsom Salt magnesium sulfate POWDER TOPICAL 20160127 OTC MONOGRAPH NOT FINAL part334 Point Guard Marketing Inc. MAGNESIUM SULFATE 10 g/10g E 20171231 70411-100_3b131a54-310a-4cce-bce6-e129a36f7c35 70411-100 HUMAN OTC DRUG Blue Green Foam Benzalkonium Chloride LIQUID TOPICAL 20160215 OTC MONOGRAPH NOT FINAL part333A H2Ocean, LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 70411-101_baa4eacb-54fc-4f8f-93ca-5b0002961bae 70411-101 HUMAN OTC DRUG Nothing Benzalkonium chloride, Lidocaine LIQUID TOPICAL 20160215 OTC MONOGRAPH NOT FINAL part333A H2Ocean, LLC BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE ANHYDROUS .13; 5 g/100mL; g/100mL N 20181231 70412-110_60de7a0f-f81f-535d-e053-2991aa0a7044 70412-110 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160119 OTC MONOGRAPH NOT FINAL part333E Zhejiang Ayan Biotech Co.,Ltd. ALCOHOL 620 mg/mL N 20181231 70412-111_60de7c68-a254-c3a5-e053-2a91aa0a4fb5 70412-111 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part333E Zhejiang Ayan Biotech Co.,Ltd. ALCOHOL 620 mg/mL N 20181231 70412-112_60de707b-5a92-3c62-e053-2991aa0a0b4b 70412-112 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part333E Zhejiang Ayan Biotech Co.,Ltd. ALCOHOL 620 mg/mL N 20181231 70412-114_60de803c-cf5d-c7d7-e053-2a91aa0a1345 70412-114 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part333E Zhejiang Ayan Biotech Co.,Ltd. ALCOHOL 620 mg/mL N 20181231 70412-119_60de8097-e0c7-6049-e053-2991aa0a32f4 70412-119 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL SPRAY TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part333E Zhejiang Ayan Biotech Co.,Ltd. ALCOHOL 620 mg/mL N 20181231 70412-120_60de707b-5a9f-3c62-e053-2991aa0a0b4b 70412-120 HUMAN OTC DRUG Alcohol Free Hand Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part333E Zhejiang Ayan Biotech Co.,Ltd. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 70412-190_60dea2de-e4d6-0f7a-e053-2991aa0a99c6 70412-190 HUMAN OTC DRUG Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20160927 OTC MONOGRAPH NOT FINAL part333E Zhejiang Ayan Biotech Co.,Ltd. ALCOHOL 620 mg/mL N 20181231 70412-210_29c94ea5-1fd9-2de5-e054-00144ff88e88 70412-210 HUMAN OTC DRUG Sunscreen OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, BENZOPHENONE-3, BUTYL METHOXYDIBENZOYLMETHANE STICK TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Zhejiang Ayan Biotech Co.,Ltd. OCTOCRYLENE; OCTINOXATE; OXYBENZONE; AVOBENZONE 80; 75; 30; 15 mg/g; mg/g; mg/g; mg/g N 20181231 70412-210_3711b3c0-1f83-466c-e054-00144ff8d46c 70412-210 HUMAN OTC DRUG Sunscreen octocrylene, ethylhexyl methoxycinnamate, benzophenone-3, butyl methoxydibenzoylmethane STICK TOPICAL 20160707 OTC MONOGRAPH NOT FINAL part352 Zhejiang Ayan Biotech Co.,Ltd. OCTOCRYLENE; OCTINOXATE; OXYBENZONE; AVOBENZONE 80; 75; 30; 15 mg/g; mg/g; mg/g; mg/g N 20181231 70412-230_60de8097-e0dd-6049-e053-2991aa0a32f4 70412-230 HUMAN OTC DRUG Sunscreen OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20160124 OTC MONOGRAPH NOT FINAL part352 Zhejiang Ayan Biotech Co.,Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 25 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 70412-239_2a555b67-c70c-0c8f-e054-00144ff8d46c 70412-239 HUMAN OTC DRUG Sunscreen OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE SPRAY TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Zhejiang Ayan Biotech Co.,Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 25 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 70412-239_60de803c-cf70-c7d7-e053-2a91aa0a1345 70412-239 HUMAN OTC DRUG SPF 30 Sunscreen OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE SPRAY TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part352 Zhejiang Ayan Biotech Co.,Ltd. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 25 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 70412-315_29c6fbf5-6877-4826-e054-00144ff8d46c 70412-315 HUMAN OTC DRUG Lip Balm SPF15 ETHYLHEXYL METHOXYCINNAMATE, BENZOPHENONE-3 STICK TOPICAL 20160118 OTC MONOGRAPH NOT FINAL part352 Zhejiang Ayan Biotech Co.,Ltd. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g N 20181231 70412-315_60de707b-5a81-3c62-e053-2991aa0a0b4b 70412-315 HUMAN OTC DRUG LIP BALM SPF15 ethylhexyl methoxycinnamate, benzophenone-3 STICK TOPICAL 20160707 OTC MONOGRAPH NOT FINAL part352 Zhejiang Ayan Biotech Co.,Ltd. OCTINOXATE; OXYBENZONE 75; 30 mg/g; mg/g N 20181231 70412-815_60de4d5f-8177-70cf-e053-2a91aa0af043 70412-815 HUMAN OTC DRUG Lip Balm SPF15 Sunscreen SPF30 Combo OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, BENZOPHENONE-3, BUTYL METHOXYDIBENZOYLMETHANE KIT 20160117 OTC MONOGRAPH NOT FINAL part352 Zhejiang Ayan Biotech Co.,Ltd. N 20181231 70414-101_9a9ec471-a51a-4b5a-af87-d44c372b7340 70414-101 HUMAN OTC DRUG OMNIBIOCIDE BENZALKONIUM CHLORIDE GEL TOPICAL 20160223 OTC MONOGRAPH NOT FINAL part333E DR MARC'S MANUFACTURING AND SALES BENZALKONIUM CHLORIDE .13 g/100g N 20181231 70414-102_45fdf79b-8221-49fe-b35e-a77258af521b 70414-102 HUMAN OTC DRUG BLUEGESIC TROLAMINE SALICYLATE SPRAY TOPICAL 20160223 OTC MONOGRAPH NOT FINAL part348 DR MARC'S MANUFACTURING AND SALES TROLAMINE SALICYLATE 10 g/100mL N 20181231 70414-103_ae6ec9f5-127b-47a4-a799-af3d2954c53e 70414-103 HUMAN OTC DRUG OMNIBIOCIDE BENZALKONIUM CHLORIDE SPRAY TOPICAL 20160323 OTC MONOGRAPH NOT FINAL part333E DR MARC'S MANUFACTURING AND SALES BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 70414-104_92ce3827-7245-419f-95dd-dba6f4c0d257 70414-104 HUMAN PRESCRIPTION DRUG CYCLO-DERM CYCLOSPORINE-A LIQUID TOPICAL 20160223 UNAPPROVED DRUG OTHER DR MARC'S MANUFACTURING AND SALES CYCLOSPORINE .25 g/100mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70414-105_81ba8953-1a74-4256-826a-c525ccb00697 70414-105 HUMAN PRESCRIPTION DRUG NAIL CYCLOSPORIN-A CYCLOSPORINE-A LIQUID TOPICAL 20160223 UNAPPROVED DRUG OTHER DR MARC'S MANUFACTURING AND SALES CYCLOSPORINE .25 g/100mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70414-106_ea8a1704-64a2-4096-b86a-1b2afec3e2e1 70414-106 HUMAN PRESCRIPTION DRUG TOPICAL NERVE PAIN KETAMINE, NEUROTIN, VALIUM, VOLTARIN CREAM TOPICAL 20160223 UNAPPROVED DRUG OTHER DR MARC'S MANUFACTURING AND SALES KETAMINE; GABAPENTIN; DIAZEPAM; DICLOFENAC SODIUM .1; .1; .1; .1 g/100mL; g/100mL; g/100mL; g/100mL General Anesthesia [PE],General Anesthetic [EPC],Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70414-107_43e518ad-0b6a-4ea3-bb6e-2bfe5c7f2f95 70414-107 HUMAN PRESCRIPTION DRUG TOPICAL PAIN VICODIN, VALIUM, IBUPROFEN, TRAMADOL CREAM TOPICAL 20160223 UNAPPROVED DRUG OTHER DR MARC'S MANUFACTURING AND SALES HYDROCODONE; DIAZEPAM; IBUPROFEN; TRAMADOL .1; .1; .1; .1 g/100mL; g/100mL; g/100mL; g/100mL Opioid Agonist [EPC],Opioid Agonists [MoA],Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Full Opioid Agonists [MoA],Opioid Agonist [EPC] N 20181231 70414-108_17622002-a8fd-4528-bc44-145f6403b8e6 70414-108 HUMAN OTC DRUG OMNISPORIN BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMIXIN B GEL TOPICAL 20170908 OTC MONOGRAPH FINAL part333B DR MARC'S MANUFACTURING AND SALES BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g N 20181231 70414-109_6c8d4945-38b6-46ef-a512-6a8ea0aacd51 70414-109 HUMAN PRESCRIPTION DRUG CICLOPIROX CICLOPIROX SOLUTION TOPICAL 20180130 UNAPPROVED DRUG OTHER DR MARC'S MANUFACTURING AND SALES CICLOPIROX 8 g/100mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20191231 70414-110_f1c2ba2a-90b5-4ed5-86d0-5a21791843bc 70414-110 HUMAN PRESCRIPTION DRUG TERBINAFINE HCL CHLORTIMAZOLE AND TOLNAFTATE TERBINAFINE HCL, CLOTRIMAZOLE, TOLNAFTATE SOLUTION TOPICAL 20180130 UNAPPROVED DRUG OTHER DR MARC'S MANUFACTURING AND SALES TERBINAFINE HYDROCHLORIDE; CLOTRIMAZOLE; TOLNAFTATE 1; 1; 1 g/100mL; g/100mL; g/100mL Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC],Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20191231 70414-111_2dbe6948-4c91-414f-8210-e1e841dc76a6 70414-111 HUMAN PRESCRIPTION DRUG TERBINAFINE HCL CICLOPIROX TERBINAFINE HCL, CICLOPIROX SOLUTION TOPICAL 20180130 UNAPPROVED DRUG OTHER DR MARC'S MANUFACTURING AND SALES TERBINAFINE HYDROCHLORIDE; CICLOPIROX 4; 4 g/100mL; g/100mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA],Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20191231 70414-201_9ef7c890-1d1d-4946-8688-3d8b1461c0ff 70414-201 HUMAN PRESCRIPTION DRUG AQUA-STASIS CYCLOSPORINE-A LIQUID OPHTHALMIC 20160223 UNAPPROVED DRUG OTHER DR MARC'S MANUFACTURING AND SALES CYCLOSPORINE .0005 g/100mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70414-202_70a72278-b4cd-47a8-a500-9ead71a02474 70414-202 HUMAN PRESCRIPTION DRUG HYDRO-STASIS CYCLOSPORINE-A LIQUID OPHTHALMIC 20160223 UNAPPROVED DRUG OTHER DR MARC'S MANUFACTURING AND SALES CYCLOSPORINE .0005 g/100mL Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70415-001_0f438b2a-9e1c-41e5-96f6-4c75c8827914 70415-001 HUMAN OTC DRUG Sierra Soft Antibacterial Wash CHLOROXYLENOL LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. CHLOROXYLENOL 5 g/L N 20181231 70415-002_d73c59f9-848e-471d-8c23-429f0d15c7a3 70415-002 HUMAN OTC DRUG Sierra Soft Alcohol Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. ALCOHOL 700 g/L E 20171231 70415-100_703d93d8-f890-4145-b6d6-1d93448c2bcd 70415-100 HUMAN OTC DRUG Sierra Soft Alcohol Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. ALCOHOL 700 mg/mL N 20181231 70415-101_b96c5282-61d2-4131-a3d2-3bdfbf021845 70415-101 HUMAN OTC DRUG Sierra Soft Antibacterial Wash CHLOROXYLENOL LIQUID TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. CHLOROXYLENOL 5 mg/mL N 20181231 70415-102_10fcdaf0-eb09-4451-8ff6-11a86d2cba72 70415-102 HUMAN OTC DRUG Sierra Soft Alcohol Foam Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. ALCOHOL 1 g/100mL N 20181231 70415-103_e1649ae2-6462-4765-81c9-cf5997f4b541 70415-103 HUMAN OTC DRUG Sierra Soft Non-Alcohol Foam Sanitizer BENZALKONIUM CHLORIDE GEL TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 70415-104_b2cdcf2c-e4b5-4a33-b83f-06061d74794a 70415-104 HUMAN OTC DRUG Sierra Soft Non-Alcohol Hand Sanitizer Foam BENZETHONIUM CHLORIDE LIQUID TOPICAL 20161213 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. BENZETHONIUM CHLORIDE 2.5 g/L N 20181231 70415-106_f1a90e27-a9f1-4b27-9edc-01cc01f0c3c7 70415-106 HUMAN OTC DRUG Sierra Soft Non-Alcohol Foam Hand Sanitizer BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 70415-201_6dfbadb1-8194-42d8-9e4c-99ddc69dd224 70415-201 HUMAN OTC DRUG Royal Antibacterial Foam Hand Wash CHLOROXYLENOL SOLUTION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. CHLOROXYLENOL .5 g/100mL N 20181231 70415-202_5d879b01-459e-4255-8b3b-f61c1e599622 70415-202 HUMAN OTC DRUG Royal 70-percent Alcohol Foam Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. ALCOHOL 70 mL/100mL N 20181231 70415-205_14a646fc-c369-4fc5-a4ca-3e85f4732a4d 70415-205 HUMAN OTC DRUG Royal Non-Alcohol Foam Hand Sanitizer Benzalkonium Chloride SOLUTION TOPICAL 20170322 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 70415-301_c4e09650-3435-4ef3-a34e-18f1ff82abf2 70415-301 HUMAN OTC DRUG PIONEER ECLIPSE TOUCHE FOAMING ANTIBACTERIAL GREEN CHLOROXYLENOL LIQUID TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. CHLOROXYLENOL .5 g/100mL N 20181231 70415-302_a1dd506c-91d6-4c2f-b7a4-b86584fc4969 70415-302 HUMAN OTC DRUG PIONEER ECLIPSE TOUCHE FOAMING HAND SANITIZER ETHYL ALCOHOL LIQUID TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. ALCOHOL 70 mL/100mL N 20181231 70415-305_8860299b-a8db-4158-9a7b-9489f9e0369b 70415-305 HUMAN OTC DRUG Pioneer Eclipse Touche Foaming Non-Alcohol Hand Sanitizer Benzalkonium Chloride SOLUTION TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 70415-401_7b9f18aa-72f9-4b91-b4b6-3318d076d012 70415-401 HUMAN OTC DRUG Puro Antibacterial Wash Foam CHLOROXYLENOL SOLUTION TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. CHLOROXYLENOL .5 g/100mL N 20181231 70415-402_cf842972-32c1-4d0f-9dd0-3520fa391d5d 70415-402 HUMAN OTC DRUG Puro 70 Percent Alcohol Foaming Hand Sanitizer ETHYL ALCOHOL SOLUTION TOPICAL 20170804 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. ALCOHOL 70 mL/100mL N 20181231 70415-405_8c86b434-59d9-41e0-8d2a-e4b13659594e 70415-405 HUMAN OTC DRUG Puro Non-Alcohol Foam Hand Sanitizer Benzalkonium Chloride SOLUTION TOPICAL 20170322 OTC MONOGRAPH NOT FINAL part333E CWGC LA Inc. BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 70416-0001_2a473aa0-6362-022e-e054-00144ff88e88 70416-0001 HUMAN OTC DRUG YEJIMIIN Feminine Wash Jeju Herb GLYCERIN LIQUID VAGINAL 20151225 OTC MONOGRAPH FINAL part347 Welcron Healthcare Company Limited GLYCERIN .5 g/100mL E 20171231 70416-0002_2a4acf3e-cb60-11d5-e054-00144ff8d46c 70416-0002 HUMAN OTC DRUG YEJIMIIN Feminine Wash Herb PANAX GINSENG ROOT LIQUID VAGINAL 20151226 UNAPPROVED DRUG OTHER Welcron Healthcare Company Limited PANAX GINSENG ROOT OIL .97 g/100mL E 20171231 70417-001_f6e97c6c-a3a0-4054-822c-4c02a1d6e4e6 70417-001 HUMAN OTC DRUG Olidental Gargle Sodium Fluoride LIQUID ORAL 20160120 OTC MONOGRAPH FINAL part355 AJU PHARM CO., LTD. SODIUM FLUORIDE .06 mg/300mL E 20171231 70417-002_469d48d0-49d5-0447-e054-00144ff8d46c 70417-002 HUMAN OTC DRUG Olea Olidental SILICON DIOXIDE PASTE ORAL 20170117 UNAPPROVED DRUG OTHER AJU PHARM CO., LTD. SILICON DIOXIDE 170 mg/g N 20181231 70418-001_334f0c80-bbdd-0e2b-e054-00144ff8d46c 70418-001 HUMAN PRESCRIPTION DRUG 20Lighter Crave Control 20L-A Peptides 20L-B Peptides Acetyl coenzyme A adenosinum triphosphoricum dinatrum adrenal cotex suis agnus castus aldosterone anacardium orientale androsterone antimonium crudum apiol argentum nitricum ATP bacopa speciosa berberis vulgaris bryonia cedron chamomilla chininum sulphuricum cholesterinum cimicifugaracemosa cina LIQUID ORAL 20160219 UNAPPROVED HOMEOPATHIC 20Lighter Health & Wellness, LLC ESTRONE; FOLLITROPIN; GAMBOGE; CHAMAELIRIUM LUTEUM ROOT; HUMULUS LUPULUS POLLEN; STRYCHNOS IGNATII SEED; IODINE; LACHESIS MUTA WHOLE; LEDUM PALUSTRE TWIG; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; MENTHA PIPERITA; SULFUR; ACETYL COENZYME A; .ALPHA.-TOCOPHEROL; CHASTE TREE; ALDOSTERONE; SEMECARPUS ANACARDIUM JUICE; ANDROSTERONE; SILVER NITRATE; ARTEMISIA CINA FLOWER; EQUOL, (+)-; HYDRASTIS CANADENSIS WHOLE; ADENOSINE TRIPHOSPHATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; SIMABA CEDRON SEED; QUININE SULFATE; CHOLESTEROL; CINCHONA OFFICINALIS BARK; CINNAMOMUM CAMPHORA WHOLE; CONVALLARIA MAJALIS; CORTISONE ACETATE; CROCUS SATIVUS FLOWER; CYCLAMEN PURPURASCENS TUBER; PRASTERONE; MATRICARIA CHAMOMILLA FLOWERING TOP OIL; BLACK COHOSH; GRAPHITE; NAJA NAJA VENOM; ALCALIGENES FAECALIS; ANTIMONY TRISULFIDE; HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA OVARY; TIN; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; TESTOSTERONE; THYROID, UNSPECIFIED; VALERIAN; VIOLA ODORATA; APIOLE (PARSLEY); PHOSPHORUS; PROGESTERONE; ANEMONE PATENS; RHODIOLA KIRILOWII WHOLE; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SENNA LEAF; SEPIA OFFICINALIS JUICE 8; 12; 6; 3; 15; 4; 6; 12; 3; 4; 6; 3; 4; 6; 6; 4; 12; 15; 12; 15; 3; 6; 3; 6; 15; 6; 4; 6; 6; 3; 12; 3; 12; 3; 3; 6; 3; 3; 15; 12; 30; 15; 12; 15; 15; 8; 12; 4; 15; 8; 6; 3; 3; 6; 6; 8; 15; 6; 15; 3; 3; 4 [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL Gonadotropin [EPC],Gonadotropins [Chemical/Ingredient],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [Chemical/Ingredient],Allergens [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient],Antimalarial [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Progesterone [Chemical/Ingredient],Progesterone [EPC] E 20171231 70418-002_35526e20-6d1d-1757-e054-00144ff88e88 70418-002 HUMAN PRESCRIPTION DRUG 20 Lighter Fat Burner 20L-A PEPTIDES LIQUID ORAL 20160304 UNAPPROVED HOMEOPATHIC 20Lighter Health & Wellness, LLC SEMECARPUS ANACARDIUM JUICE; .ALPHA.-LIPOIC ACID; BELLADONNA LEAF; EQUOL, (+)-; SUS SCROFA ESOPHAGUS; FORMIC ACID; SUS SCROFA GALLBLADDER; INSULIN ARGINE; SULFUR; HUMAN THYMUS; SUS SCROFA URINARY BLADDER; VERATRUM ALBUM ROOT; CYNANCHUM VINCETOXICUM ROOT; PORK LIVER; CARAPICHEA IPECACUANHA WHOLE; LYCOPODIUM CLAVATUM WHOLE; MENADIONE; METHYLCOBALAMIN; MOMORDICA BALSAMINA WHOLE; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA ORAL MUCOSA; SUS SCROFA PANCREAS; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SUS SCROFA DUODENUM; HYDRASTIS CANADENSIS WHOLE; GELSEMIUM SEMPERVIRENS ROOT; CEANOTHUS AMERICANUS LEAF; SUS SCROFA ILEUM; LACHESIS MUTA VENOM; SUS SCROFA LUNG; SUS SCROFA NASAL MUCOSA; PULSATILLA VULGARIS; LACTIC ACID, L-; ADENOSINE TRIPHOSPHATE; AVENA SATIVA FLOWERING TOP; MILK THISTLE; CHELIDONIUM MAJUS; CHOLESTEROL; GLUCAGON; SILVER NITRATE; MARSDENIA CUNDURANGO WHOLE; CYNARA SCOLYMUS LEAF; YEAST MANNAN; SUS SCROFA CEREBRUM; SHIGELLA DYSENTERIAE; ECHINACEA ANGUSTIFOLIA; SUS SCROFA EYE; SUS SCROFA HYPOTHALAMUS; PORK INTESTINE; SUS SCROFA JEJUNUM; MANDRAGORA OFFICINARUM ROOT; PROTEUS INCONSTANS; PORK KIDNEY; SUS SCROFA STOMACH; GAMBOGE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TARAXACUM OFFICINALE; WOOD CREOSOTE; SUS SCROFA BILE DUCT; GRAPHITE; GLYOXAL; CINCHONA OFFICINALIS BARK; SUS SCROFA COLON; .ALPHA.-KETOGLUTARIC ACID 8; 6; 10; 8; 8; 10; 8; 30; 13; 8; 6; 4; 6; 8; 8; 4; 6; 8; 8; 60; 8; 8; 8; 60; 6; 4; 60; 4; 8; 10; 10; 8; 6; 30; 30; 6; 3; 4; 10; 30; 6; 6; 6; 10; 8; 30; 8; 8; 6; 8; 8; 10; 30; 8; 8; 12; 12; 4; 10; 8; 60; 10; 4; 8; 10 [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_C]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL; [hp_X]/60mL Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Seed Storage Proteins [Chemical/Ingredient],Antihypoglycemic Agent [EPC],Gastrointestinal Motility Inhibitor [EPC],Increased Gluconeogenesis [PE],Increased Glycogenolysis [PE],Decreased GI Smooth Muscle Tone [PE],Decreased GI Motility [PE],Decreased Glycolysis [PE] E 20171231 70423-001_2ab81436-9ede-685f-e054-00144ff88e88 70423-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20160201 NDA NDA205849 DANI Inc OXYGEN 990 mL/L E 20171231 70423-001_2c5e1235-d1d0-1f14-e054-00144ff88e88 70423-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20160222 NDA NDA205849 DANI Inc OXYGEN 990 mL/L E 20171231 70423-001_2c5e9c23-12ac-3ddb-e054-00144ff88e88 70423-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20160222 NDA NDA205849 DANI Inc OXYGEN 990 mL/L E 20171231 70423-001_2d037d75-f212-04d7-e054-00144ff8d46c 70423-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20160302 NDA NDA205849 DANI Inc OXYGEN 990 mL/L E 20171231 70424-001_29e3968b-6055-28ae-e054-00144ff8d46c 70424-001 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20160122 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 62 mL/100mL N 20181231 70424-001_2aebc14d-9725-1a87-e054-00144ff88e88 70424-001 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20160122 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 62 mL/100mL N 20181231 70424-001_35520fcb-07ec-0d17-e054-00144ff88e88 70424-001 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20160615 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 62 mL/100mL N 20181231 70424-001_35ac47ee-ea42-7360-e054-00144ff8d46c 70424-001 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20160615 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 62 mL/100mL N 20181231 70424-002_48d9d9c2-ccc4-17dc-e054-00144ff8d46c 70424-002 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20160615 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 63 mL/100mL N 20181231 70424-002_48da4daf-a605-2c5d-e054-00144ff88e88 70424-002 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20160615 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 63 mL/100mL N 20181231 70424-002_48da4daf-a607-2c5d-e054-00144ff88e88 70424-002 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20160122 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 63 mL/100mL N 20181231 70424-002_48da5ad7-e294-3a4e-e054-00144ff8d46c 70424-002 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20160122 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 63 mL/100mL N 20181231 70424-003_50ce0b45-b61d-3a89-e054-00144ff88e88 70424-003 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 63 mL/100mL N 20181231 70424-003_50ce500c-4967-2a1e-e054-00144ff8d46c 70424-003 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 63 mL/100mL N 20181231 70424-003_50cec588-9c2a-2088-e054-00144ff88e88 70424-003 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 63 mL/100mL N 20181231 70424-003_50cec588-9c3a-2088-e054-00144ff88e88 70424-003 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 63 mL/100mL N 20181231 70424-003_50d1c5e9-d4bb-3ddd-e054-00144ff88e88 70424-003 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 63 mL/100mL N 20181231 70424-003_50d28886-3cf9-7080-e054-00144ff88e88 70424-003 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 63 mL/100mL N 20181231 70424-003_50d28886-3d09-7080-e054-00144ff88e88 70424-003 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 63 mL/100mL N 20181231 70424-003_50d2b56a-c65f-02ef-e054-00144ff88e88 70424-003 HUMAN OTC DRUG Hand Sanitizer with Aloe ETHYL ALCOHOL GEL TOPICAL 20170531 OTC MONOGRAPH NOT FINAL part333E Evergreen Research and Marketing, LLC ALCOHOL 63 mL/100mL N 20181231 70425-101_31b3b630-b316-4397-8104-a72bb0f8e387 70425-101 HUMAN OTC DRUG NERD ACNE TREATMENT SULFUR LOTION TOPICAL 20160301 OTC MONOGRAPH FINAL part333D Panco Cosmetics Corp. SULFUR .9 g/30mL N 20181231 70430-001_5fdba3dd-6603-dc7a-e053-2a91aa0aff72 70430-001 HUMAN OTC DRUG Alcohol Pad ISOPROPYL ALCOHOL PATCH TOPICAL 20170427 OTC MONOGRAPH NOT FINAL part333A LaMi Products INC. ISOPROPYL ALCOHOL 70 g/100g N 20181231 70430-010_60efb374-c926-7f99-e053-2a91aa0adf09 70430-010 HUMAN OTC DRUG First Aid Kit alcohol KIT 20170106 OTC MONOGRAPH NOT FINAL part333E Lami Products, Inc. N 20181231 70434-101_ec25ff67-b492-4a16-9064-8b058bba041f 70434-101 HUMAN OTC DRUG EDP HENNA LAWSONIA INERMIS LEAF POWDER TOPICAL 20160201 UNAPPROVED DRUG OTHER EDP Inc. LAWSONIA INERMIS LEAF .999 1/100g N 20181231 70434-102_3a5e67b1-1cc0-46de-bc0b-58c8e7d0f3fd 70434-102 HUMAN OTC DRUG EDP INDIGO Indigofera Tinctoria Leaf POWDER TOPICAL 20160201 UNAPPROVED DRUG OTHER EDP Inc. INDIGOFERA TINCTORIA LEAF .999 1/100g N 20181231 70434-103_c83ec03f-b979-4b45-be33-204a04f4c647 70434-103 HUMAN OTC DRUG EDP BROWN INDIGOFERA TINCTORIA LEAF POWDER TOPICAL 20160201 UNAPPROVED DRUG OTHER EDP Inc. INDIGOFERA TINCTORIA LEAF .6 1/100g N 20181231 70436-004_56e24492-3a3e-67c5-e054-00144ff8d46c 70436-004 HUMAN PRESCRIPTION DRUG Galantamine galantamine TABLET, FILM COATED ORAL 20170802 ANDA ANDA077604 Slate Run Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 4 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 70436-005_56e24492-3a3e-67c5-e054-00144ff8d46c 70436-005 HUMAN PRESCRIPTION DRUG Galantamine galantamine TABLET, FILM COATED ORAL 20170802 ANDA ANDA077604 Slate Run Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 8 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 70436-006_56e24492-3a3e-67c5-e054-00144ff8d46c 70436-006 HUMAN PRESCRIPTION DRUG Galantamine galantamine TABLET, FILM COATED ORAL 20170802 ANDA ANDA077604 Slate Run Pharmaceuticals, LLC GALANTAMINE HYDROBROMIDE 12 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 70436-050_b036e172-9bd4-4430-814a-aa12cf1a67be 70436-050 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20180101 ANDA ANDA077208 Slate Run Pharmaceuticals CILOSTAZOL 50 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20191231 70436-051_b036e172-9bd4-4430-814a-aa12cf1a67be 70436-051 HUMAN PRESCRIPTION DRUG Cilostazol Cilostazol TABLET ORAL 20180101 ANDA ANDA077208 Slate Run Pharmaceuticals CILOSTAZOL 100 mg/1 Phosphodiesterase 3 Inhibitor [EPC],Phosphodiesterase 3 Inhibitors [MoA] N 20191231 70437-240_20dd2a2c-5534-4bca-91eb-90ae9692bc3d 70437-240 HUMAN PRESCRIPTION DRUG Nerlynx neratinib TABLET ORAL 20170717 NDA NDA208051 Puma Biotechnology, Inc. NERATINIB MALEATE 40 mg/1 Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70441-0001_2d7fc7f6-1e8c-116c-e054-00144ff8d46c 70441-0001 HUMAN OTC DRUG BENJAMIN BUTTON TIME REVERSE WRINKLE FILL UP DIMETHICONE CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part347 Pioom Cosmetic Co.,ltd DIMETHICONE 2 g/100mL N 20181231 70441-0002_2da8489d-e2e4-4ecb-e054-00144ff88e88 70441-0002 HUMAN OTC DRUG Skin Barista Rice Bran Cleansing Foam ALLANTOIN LIQUID TOPICAL 20160204 OTC MONOGRAPH FINAL part347 Pioom Cosmetic Co.,ltd ALLANTOIN .3 g/100mL N 20181231 70441-0003_2d7fc20c-31a8-195b-e054-00144ff88e88 70441-0003 HUMAN OTC DRUG Skin Barista 2in1 White Body Perfection DIMETHICONE CREAM TOPICAL 20160307 OTC MONOGRAPH FINAL part347 Pioom Cosmetic Co.,ltd DIMETHICONE 1.5 g/100mL N 20181231 70441-0004_34e79668-0711-5753-e054-00144ff88e88 70441-0004 HUMAN OTC DRUG ARGAN AIR WATER BANG ESSENCE DIMETHICONE CREAM TOPICAL 20160608 OTC MONOGRAPH FINAL part347 Pioom Cosmetic Co.,ltd DIMETHICONE .01 g/100mL N 20181231 70441-0005_50b7db48-7b56-6df4-e054-00144ff88e88 70441-0005 HUMAN OTC DRUG FIND BICHON CLEANSING MASK GLYCERIN LIQUID TOPICAL 20170501 UNAPPROVED DRUG OTHER Pioom Cosmetic Co.,ltd GLYCERIN 1 g/100g N 20181231 70445-156_3f259fdb-c69e-0135-e054-00144ff8d46c 70445-156 HUMAN OTC DRUG Sun Screen Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE 4; 7; 4; 3 g/100g; g/100g; g/100g; g/100g E 20171231 70445-157_3f259fdb-c6a7-0135-e054-00144ff8d46c 70445-157 HUMAN OTC DRUG Sun Screen Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE 4; 7; 4; 3 g/100g; g/100g; g/100g; g/100g E 20171231 70445-158_3f27e51d-3860-11f2-e054-00144ff8d46c 70445-158 HUMAN OTC DRUG Sun Screen Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE 4; 7; 4; 3 g/100g; g/100g; g/100g; g/100g E 20171231 70445-159_3f3b6227-4c6a-35ae-e054-00144ff8d46c 70445-159 HUMAN OTC DRUG SSLT2 Sun Screen Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE 4; 7; 4; 3 g/100g; g/100g; g/100g; g/100g E 20171231 70445-165_4a1262d4-5db0-17b1-e054-00144ff88e88 70445-165 HUMAN OTC DRUG Lip Balm Vanilla Flavored SPF 30 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions HOMOSALATE; OCTINOXATE; OXYBENZONE; MERADIMATE 6; 7.5; 6; 4 g/100g; g/100g; g/100g; g/100g N 20181231 70445-222_49119f8f-38e0-6800-e054-00144ff8d46c 70445-222 HUMAN OTC DRUG Lip Balm Blueberry Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-223_4984df21-c363-1769-e054-00144ff88e88 70445-223 HUMAN OTC DRUG Lip Balm Bacon Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-224_498a1fce-c97f-27aa-e054-00144ff8d46c 70445-224 HUMAN OTC DRUG Lip Balm Peppermint Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-225_499c61bd-8ced-48cd-e054-00144ff8d46c 70445-225 HUMAN OTC DRUG Lip Balm Unflavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-226_498a2cc2-40b0-29b5-e054-00144ff8d46c 70445-226 HUMAN OTC DRUG Lip Balm Watermelon Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-227_498a2cc2-40be-29b5-e054-00144ff8d46c 70445-227 HUMAN OTC DRUG Lip Balm Peppermint Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-228_498a34d2-26a1-2b9c-e054-00144ff8d46c 70445-228 HUMAN OTC DRUG Lip Balm Vanilla Mint Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-229_498a34d2-26b0-2b9c-e054-00144ff8d46c 70445-229 HUMAN OTC DRUG Lip Balm Vanilla Coffee Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-230_49979756-45ed-25eb-e054-00144ff88e88 70445-230 HUMAN OTC DRUG Lip Balm Vanilla Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-231_499c61bd-8cea-48cd-e054-00144ff8d46c 70445-231 HUMAN OTC DRUG Lip Balm Tropical Punch Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-232_499c61bd-8d03-48cd-e054-00144ff8d46c 70445-232 HUMAN OTC DRUG Lip Balm Tangerine Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-233_499c2627-204a-3ddb-e054-00144ff88e88 70445-233 HUMAN OTC DRUG Lip Balm Strawberry Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-234_499d366a-a7d9-6070-e054-00144ff88e88 70445-234 HUMAN OTC DRUG Lip Balm Spearmint Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-235_49af3aa9-91ca-0e10-e054-00144ff8d46c 70445-235 HUMAN OTC DRUG Lip Balm Root Beer Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-236_49af5adf-dadd-60a0-e054-00144ff88e88 70445-236 HUMAN OTC DRUG Lip Balm Raspberry Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-237_49af3aa9-91ce-0e10-e054-00144ff8d46c 70445-237 HUMAN OTC DRUG Lip Balm Popcorn Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-238_49ae89d7-489d-5432-e054-00144ff8d46c 70445-238 HUMAN OTC DRUG Lip Balm Pomegranate Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-239_49af0ef8-399a-14c4-e054-00144ff8d46c 70445-239 HUMAN OTC DRUG Lip Balm Pink Grapefruit Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-240_49af8aa7-1c91-2c0f-e054-00144ff8d46c 70445-240 HUMAN OTC DRUG Lip Balm Pina Colada Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-241_49d8e1f7-d53f-2d58-e054-00144ff88e88 70445-241 HUMAN OTC DRUG Lip Balm Peach Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-242_49d8d39f-4286-31bf-e054-00144ff8d46c 70445-242 HUMAN OTC DRUG Lip Balm Orange Crush Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-243_49b0ad80-3cac-6de0-e054-00144ff8d46c 70445-243 HUMAN OTC DRUG Lip Balm Mint Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-244_49b0ad80-3cb0-6de0-e054-00144ff8d46c 70445-244 HUMAN OTC DRUG Lip Balm Margarita Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-245_49b03df2-40be-4e5c-e054-00144ff8d46c 70445-245 HUMAN OTC DRUG Lip Balm Mango Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-246_49b0e674-f4c6-6c4a-e054-00144ff8d46c 70445-246 HUMAN OTC DRUG Lip Balm Lime Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-247_49b0ed96-a715-05cf-e054-00144ff8d46c 70445-247 HUMAN OTC DRUG Lip Balm Lemonade Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-248_49b12d66-2660-263d-e054-00144ff88e88 70445-248 HUMAN OTC DRUG Lip Balm Lemon Lime Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-249_49b0c9af-ab74-72c7-e054-00144ff8d46c 70445-249 HUMAN OTC DRUG Lip Balm Green Tea Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-250_49b1b006-b840-354e-e054-00144ff88e88 70445-250 HUMAN OTC DRUG Lip Balm Green Apple Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-251_49b19c1b-9279-25ec-e054-00144ff8d46c 70445-251 HUMAN OTC DRUG Lip Balm Grape Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-253_49b0ece6-5875-7133-e054-00144ff8d46c 70445-253 HUMAN OTC DRUG Lip Balm Cotton Candy Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-254_49b25e9e-1d38-4a10-e054-00144ff8d46c 70445-254 HUMAN OTC DRUG Lip Balm Cola Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-255_49b25e9e-1d46-4a10-e054-00144ff8d46c 70445-255 HUMAN OTC DRUG Lip Balm Coffee Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-256_49b25e9e-1d54-4a10-e054-00144ff8d46c 70445-256 HUMAN OTC DRUG Lip Balm Coconut Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-257_49b25e9e-1d6c-4a10-e054-00144ff8d46c 70445-257 HUMAN OTC DRUG Lip Balm Citrus Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-258_49b29dce-18ab-48c6-e054-00144ff8d46c 70445-258 HUMAN OTC DRUG Lip Balm Cinnamon Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-259_49b29dce-18ef-48c6-e054-00144ff8d46c 70445-259 HUMAN OTC DRUG Lip Balm Chocolate Peppermint Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-260_49b2a270-c64a-4e67-e054-00144ff8d46c 70445-260 HUMAN OTC DRUG Lip Balm Chocolate Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-261_49bf8a17-d9e8-2876-e054-00144ff88e88 70445-261 HUMAN OTC DRUG Lip Balm Cherry Cola Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-262_49c024ae-d8e5-1fc8-e054-00144ff8d46c 70445-262 HUMAN OTC DRUG Lip Balm Cherry Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-263_49bf8a17-da17-2876-e054-00144ff88e88 70445-263 HUMAN OTC DRUG Lip Balm Caramel Apple Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-264_49c024ae-d8f0-1fc8-e054-00144ff8d46c 70445-264 HUMAN OTC DRUG Lip Balm Campfire Smores Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-265_49c4b182-4317-11cb-e054-00144ff8d46c 70445-265 HUMAN OTC DRUG Lip Balm Cafe Latte Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-266_49c4ad75-bc4f-0d12-e054-00144ff8d46c 70445-266 HUMAN OTC DRUG Lip Balm Bubble Gum Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-267_49c4b365-5a85-1281-e054-00144ff8d46c 70445-267 HUMAN OTC DRUG Lip Balm Bourbon Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-268_49c4ad75-bc50-0d12-e054-00144ff8d46c 70445-268 HUMAN OTC DRUG Lip Balm Blue Raspberry Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-269_49c623c6-d960-10e9-e054-00144ff88e88 70445-269 HUMAN OTC DRUG Lip Balm Berry Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-270_49c65f9f-0b6e-601b-e054-00144ff8d46c 70445-270 HUMAN OTC DRUG Lip Balm Beer Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-271_49c623c6-d9c9-10e9-e054-00144ff88e88 70445-271 HUMAN OTC DRUG Lip Balm Banana Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-272_49c65f9f-0b80-601b-e054-00144ff8d46c 70445-272 HUMAN OTC DRUG Lip Balm Asian Pear Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-273_49c6b048-1671-71bc-e054-00144ff8d46c 70445-273 HUMAN OTC DRUG Lip Balm Apple Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-274_49c6d880-445e-047b-e054-00144ff8d46c 70445-274 HUMAN OTC DRUG Lip Balm Pineapple Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70445-275_49c6d880-4465-047b-e054-00144ff8d46c 70445-275 HUMAN OTC DRUG Lip Balm Chocolate Strawberry Flavored SPF 15 LIPSTICK TOPICAL 20090101 OTC MONOGRAPH FINAL part352 Webb Business Promotions OCTINOXATE; OCTISALATE; OXYBENZONE 3.6; 2.5; 1.5 g/g; g/g; g/g N 20181231 70446-640_e15eaab1-ffdc-4308-bb6f-757f758acb29 70446-640 HUMAN OTC DRUG Tea Tree Oil Antiseptic Melaleuca Alternifolia (Tea Tree) Leaf Oil OIL TOPICAL 20160816 UNAPPROVED DRUG OTHER Integria Healthcare (Australia) Pty. Ltd. TEA TREE OIL 15 mL/15mL N 20181231 70446-643_6f436e0e-1a6f-4b0e-9719-84c02855b6f9 70446-643 HUMAN OTC DRUG Tea Tree Antiseptic Cream Melaleuca Alternifolia (Tea Tree) Leaf Oil CREAM TOPICAL 20160618 UNAPPROVED DRUG OTHER Integria Healthcare (Australia) Pty. Ltd. TEA TREE OIL 5 g/100g N 20181231 70449-1000_50ad63a5-f3e9-116b-e054-00144ff8d46c 70449-1000 HUMAN OTC DRUG Cold Bee Gone Kali Bichromicum 6X, Sabadilla 6X, Luffa Operculata 6X LIQUID NASAL 20131101 UNAPPROVED HOMEOPATHIC Buzzagogo, LLC POTASSIUM DICHROMATE; SCHOENOCAULON OFFICINALE SEED; LUFFA OPERCULATA FRUIT 6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 70452-010_c5fa3bd5-254e-4d21-8b8b-b11edc38c87e 70452-010 HUMAN OTC DRUG Nlihome Dental Care HYDRATED SILICA, SODIUM PYROPHOSPHATE, .ALPHA.-TOCOPHEROL ACETATE, D- PASTE, DENTIFRICE ORAL 20160102 UNAPPROVED DRUG OTHER Kumho Dental Pharm. Co., Ltd. HYDRATED SILICA; SODIUM PYROPHOSPHATE; .ALPHA.-TOCOPHEROL ACETATE, D- 30; 1; .18 g/200g; g/200g; g/200g E 20171231 70453-001_2af27f1c-7008-27bf-e054-00144ff8d46c 70453-001 HUMAN OTC DRUG Protect and Prime Broad Spectrum SPF30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20160203 OTC MONOGRAPH NOT FINAL part352 Emma Hardie Ltd AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 30; 75; 100; 60 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 70458-101_617acb8f-c519-445a-bc34-c6bf50f910f4 70458-101 HUMAN OTC DRUG Procicept L Lidocaine 4% Lidocaine and Menthol LIQUID TOPICAL 20170201 20191231 OTC MONOGRAPH NOT FINAL part348 Nocicept Technologies, Inc. LIDOCAINE; MENTHOL .04; .01 g/g; g/g N 20191231 70458-102_cbcc5847-ca42-4d9c-a1b2-d483a4488419 70458-102 HUMAN OTC DRUG Procicept B Benzocaine 20% Benzocaine and Menthol LIQUID TOPICAL 20171101 20191231 OTC MONOGRAPH NOT FINAL part348 Nocicept Technologies, Inc. BENZOCAINE; MENTHOL .2; .01 g/g; g/g N 20191231 70458-500_2ac48aff-82b5-4c99-bd4d-8b6bed6f3f0b 70458-500 HUMAN OTC DRUG Topical Edge Menthol LOTION TOPICAL 20170304 20190304 OTC MONOGRAPH NOT FINAL part348 AmperSand Biopharma MENTHOL .5 g/100g N 20181231 70458-500_5815d5b2-5fc0-780a-e053-2a91aa0ae946 70458-500 HUMAN OTC DRUG Topical Edge Menthol LOTION TOPICAL 20170925 OTC MONOGRAPH NOT FINAL part348 AmperSand Biopharma MENTHOL .5 g/100g N 20181231 70460-001_4e6555d7-29b5-43e5-8b3c-90c8e0b4f046 70460-001 VACCINE Vaxchora Cholera Vaccine, Live, Oral KIT 20161003 BLA BLA125597 Paxvax, Inc. N 20181231 70461-002_8846ea55-4e1f-41fc-909b-84c612ab5b87 70461-002 VACCINE FLUAD A/Singapore/GP1908/2015 IVR-180 (H1N1) (an A/Michigan/45/2015 (H1N1)pdm09-like virus), A/Hong Kong/4801/2014, NYMC X-263B (H3N2) (an A/Hong Kong/4801/2014-like virus), and B/Brisbane/60/2008, wild type (a B/Brisbane/60/2008-like virus) INJECTION, SUSPENSION INTRAMUSCULAR 20170701 20180630 BLA BLA125510 Seqirus Inc. INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL N 20181231 70461-120_b483a28e-2233-4285-b755-267b9f166dc9 70461-120 VACCINE Fluvirin A/Singapore/GP1908/2015 IVR-180 (an A/Michigan/45/2015 (H1N1)pdm09-like virus, A/Hong Kong/4801/2014, NYMC X-263B (H3N2) (an A/Hong Kong/4801/2014-like virus), and B/Brisbane/60/2008, wild type (a B/Brisbane/60/2008-like virus) INJECTION, SUSPENSION INTRAMUSCULAR 20170701 20180630 BLA BLA103837 Seqirus Inc. INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED) 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL Inactivated Influenza B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Influenza Vaccines [Chemical/Ingredient] N 20181231 70461-201_b1eda076-5bf4-4fd9-8a66-c106b99633ad 70461-201 VACCINE FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE) A/Singapore/GP1908/2015 IVR-180 (H1N1) (an A/Michigan/45/2015-like virus), A/Singapore/GP2050/2015 (H3N2) (an A/Hong Kong/4801/2014 - like virus), B/Utah/9/2014 (a B/Phuket/3073/2013-like virus), B/Hong Kong/259/2010 (a B/Brisbane/60/08-like virus) INJECTION, SUSPENSION INTRAMUSCULAR 20170701 20180630 BLA BLA125408 Seqirus, Inc. INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/HONG KONG/259/2010 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL N 20181231 70461-301_b1eda076-5bf4-4fd9-8a66-c106b99633ad 70461-301 VACCINE FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) A/Singapore/GP1908/2015 IVR-180 (H1N1) (an A/Michigan/45/2015-like virus), A/Singapore/GP2050/2015 (H3N2) (an A/Hong Kong/4801/2014 - like virus), B/Utah/9/2014 (a B/Phuket/3073/2013-like virus), B/Hong Kong/259/2010 (a B/Brisbane/60/08-like virus) INJECTION, SUSPENSION INTRAMUSCULAR 20170701 20180630 BLA BLA125408 Seqirus, Inc. INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/UTAH/9/2014 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/HONG KONG/259/2010 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15; 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL N 20181231 70463-725_60dffd9a-5c08-03c9-e053-2991aa0a0382 70463-725 HUMAN OTC DRUG SOMXL Homeopathic Wart Remover THUJA OCCIDENTALIS LEAFY TWIG CREAM TOPICAL 20160205 UNAPPROVED HOMEOPATHIC WR Group Skin Care Ltd THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/15g N 20181231 70465-0001_2aff7640-2203-6daf-e054-00144ff8d46c 70465-0001 HUMAN OTC DRUG Ramosu Aloe Vera Leaf Extract 100 ALOE BARBADENSIS LEAF LIQUID TOPICAL 20160204 UNAPPROVED DRUG OTHER RaMoSu ALOE VERA LEAF 100 g/100mL N 20181231 70465-0002_2aff7640-21bf-6daf-e054-00144ff8d46c 70465-0002 HUMAN OTC DRUG Ramosu Collagen Ampoule 200 Collagen LIQUID TOPICAL 20160204 UNAPPROVED DRUG OTHER RaMoSu FISH SKIN COLLAGEN, SOLUBLE 100 g/100mL N 20181231 70465-0003_2afdb515-3366-3555-e054-00144ff88e88 70465-0003 HUMAN OTC DRUG Ramosu Hyaluronic Acid Solution 100 HYALURONATE SODIUM LIQUID TOPICAL 20160204 UNAPPROVED DRUG OTHER RaMoSu HYALURONATE SODIUM 100 g/100mL N 20181231 70465-0004_2aff7640-21ce-6daf-e054-00144ff8d46c 70465-0004 HUMAN OTC DRUG Ramosu Propolis Extract 100 PROPOLIS LIQUID TOPICAL 20160204 UNAPPROVED DRUG OTHER RaMoSu PROPOLIS WAX 100 g/100mL N 20181231 70465-0005_2b00baa5-9bdb-26c2-e054-00144ff8d46c 70465-0005 HUMAN OTC DRUG Ramosu Snail Mucin Filtrate 100 snail secretion filtrate LIQUID TOPICAL 20160204 UNAPPROVED DRUG OTHER RaMoSu SNAIL, UNSPECIFIED 100 g/100mL N 20181231 70465-0006_2c54d6d7-71e0-0403-e054-00144ff8d46c 70465-0006 HUMAN OTC DRUG Ramosu Recovery Oil Drop Serum DIMETHICONE LIQUID TOPICAL 20160204 OTC MONOGRAPH FINAL part347 RaMoSu DIMETHICONE 53.1 g/100mL N 20181231 70465-0007_2d6fc62e-09ab-52b9-e054-00144ff8d46c 70465-0007 HUMAN OTC DRUG Ramosu Regenerating Spot Face DIMETHICONE CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part347 RaMoSu DIMETHICONE .3 g/100mL N 20181231 70465-0008_2c54d6d7-71df-0403-e054-00144ff8d46c 70465-0008 HUMAN OTC DRUG Ramosu Kindal Butter Balm GLYCERIN CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part347 RaMoSu GLYCERIN .05 g/100g N 20181231 70465-0009_2d6fc62e-09ac-52b9-e054-00144ff8d46c 70465-0009 HUMAN OTC DRUG Ramosu The Star Mild Sunscreen ZINC OXIDE CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part347 RaMoSu ZINC OXIDE 4.9 g/100mL N 20181231 70465-0010_2c6861b2-d008-4883-e054-00144ff88e88 70465-0010 HUMAN OTC DRUG Ramosu The Witches Cream Pack Gold allantoin LIQUID TOPICAL 20160204 OTC MONOGRAPH FINAL part347 RaMoSu ALLANTOIN .1 g/100g N 20181231 70466-001_2b486b8a-1b8e-3f01-e054-00144ff88e88 70466-001 HUMAN OTC DRUG Bed Bug Instant Bite Relief LIDOCAINE GEL TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part348 P.F. Harris Mfg. Co. LLC LIDOCAINE 40 mg/g N 20181231 70467-168_e5f60b74-2afa-4d92-afac-9fea3d84efba 70467-168 HUMAN OTC DRUG MERIDIAN BALM Camphor, Menthol OINTMENT TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part348 6c23, Llc CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM 3; 1 g/100g; g/100g E 20171231 70467-812_1bfaf5a7-6101-47bb-bd2e-b06a367dcf91 70467-812 HUMAN OTC DRUG KUNG FU PAIN RELIEF Menthol, Methyl Salicylate PATCH TOPICAL 20170309 OTC MONOGRAPH NOT FINAL part348 6c23, Llc MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE 2; .5 g/100g; g/100g N 20181231 70470-1001_3f9f6bd4-58c0-4b49-e054-00144ff88e88 70470-1001 HUMAN OTC DRUG Rosatra Synergy for treatment of Acne Rosacea Rosatra OIL TOPICAL 20160229 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. EUCALYPTOL .7 g/50g N 20181231 70470-1002_3fa059c8-0711-65a7-e054-00144ff8d46c 70470-1002 HUMAN OTC DRUG Acne Vanish Synergy for treatment of Acnes Acne Vanish OIL TOPICAL 20160229 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. THYMOL .7 g/50g N 20181231 70470-1006_3f9e08c9-f2af-1fee-e054-00144ff88e88 70470-1006 HUMAN OTC DRUG Cellulitica Synergy Cellulitica OIL TOPICAL 20160229 OTC MONOGRAPH FINAL part341 PHYTOPIA CO., LTD. MENTHOL 1.5 g/50g N 20181231 70470-1008_3fa33885-531c-23c4-e054-00144ff8d46c 70470-1008 HUMAN OTC DRUG Dermatitica Synergy for treatment of Dermatitis Dermatitica OIL TOPICAL 20160401 OTC MONOGRAPH FINAL part346 PHYTOPIA CO., LTD. COCOA BUTTER 3.2 mg/50mL N 20181231 70470-1011_2c010c2e-d877-4a72-e054-00144ff88e88 70470-1011 HUMAN OTC DRUG menthol Cellulitica OIL TOPICAL 20160229 OTC MONOGRAPH FINAL part341 PHYTOPIA CO., LTD. MENTHOL .5 mg/50mL CV N 20181231 70470-1013_3fa2fa6c-1954-48d5-e054-00144ff88e88 70470-1013 HUMAN OTC DRUG Atopic Healer Synergy Atopic Healer OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part347 PHYTOPIA CO., LTD. BALSAM PERU OIL; COCOA BUTTER 3.6; 4.9 mg/50mL; mg/50mL N 20181231 70470-1020_3fa1a19a-4a83-1fad-e054-00144ff88e88 70470-1020 HUMAN OTC DRUG Keloid Healer Synergy for treatment of keloids Keloid Healer OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part347 PHYTOPIA CO., LTD. EUCALYPTOL; BALSAM PERU OIL 1.3; 1.2 mg/50mg; mg/50mg N 20181231 70470-1118_321a7972-a099-66d8-e054-00144ff8d46c 70470-1118 HUMAN OTC DRUG PainAway with natural peppermint and Balsam Peru PainAway OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part347 PHYTOPIA CO., LTD. MENTHOL; BALSAM PERU OIL 1.3; 1.2 mg/50mg; mg/50mg N 20181231 70470-1123_41575b52-9162-1671-e054-00144ff8d46c 70470-1123 HUMAN OTC DRUG Osteoarthritica Synergy for treatment of Osteoarthritis Osteoarthritica OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. MENTHOL 7 mg/50mL N 20181231 70470-1130_3fa2163d-90de-5a1f-e054-00144ff8d46c 70470-1130 HUMAN OTC DRUG Rheumatica Synergy for treatment of Rheumatitis Rheumatica OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. MENTHOL 7 mg/50mL N 20181231 70470-1139_3fa14788-b953-176e-e054-00144ff88e88 70470-1139 HUMAN OTC DRUG Tendinitica Synergy for treatment of Tendinitis Tendinitica OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. MENTHOL 1.3 mg/50mg N 20181231 70470-1204_3fa1f249-827d-4487-e054-00144ff8d46c 70470-1204 HUMAN OTC DRUG ADHD Care Synergy ADHD Care OIL TOPICAL 20160229 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. SAGE OIL 8 mg/50mL N 20181231 70470-1401_3fa259dd-1713-677d-e054-00144ff8d46c 70470-1401 HUMAN OTC DRUG Asthma Aide Synergy Asthma Aide OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. MENTHOL; BALSAM PERU OIL 4.3; 4 mg/50mL; mg/50mL N 20181231 70470-1402_3fa259dd-1705-677d-e054-00144ff8d46c 70470-1402 HUMAN OTC DRUG Acute Bronchitis Synergy Acute Bronchitis OIL TOPICAL 20160229 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. THYMOL 1.5 g/50g N 20181231 70470-1403_3fa26d8a-d068-6ca4-e054-00144ff8d46c 70470-1403 HUMAN OTC DRUG Chronic Bronchitis Synergy Chronic Bronchitis OIL TOPICAL 20160229 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. THYMOL .5 g/50g N 20181231 70470-1405_3fa2c0ea-1b14-08ac-e054-00144ff8d46c 70470-1405 HUMAN OTC DRUG Common Colds Synergy Common Colds OIL TOPICAL 20160229 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. THYMOL 1.5 g/50g N 20181231 70470-1408_3fa2fb17-e2ad-4bb6-e054-00144ff88e88 70470-1408 HUMAN OTC DRUG Influenza Care Synergy Influenza Care OIL TOPICAL 20160229 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. THYMOL 1.7 g/50g N 20181231 70470-1610_4e877497-a3f0-5a52-e054-00144ff88e88 70470-1610 HUMAN OTC DRUG GLP-1 Balance Synergy GLP-1 Balance OIL TOPICAL; TRANSDERMAL 20160401 OTC MONOGRAPH NOT FINAL part356 Phytopia Co., Ltd. EUCALYPTUS OIL; SAGE OIL 60; 40 mg/50mL; mg/50mL N 20181231 70470-1805_614a5e5a-54c2-488f-e053-2a91aa0a38a0 70470-1805 HUMAN OTC DRUG Menstrual Pain Synergy for treatment of Menstrual Pain Menstrual Pain OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. MENTHOL 6 mg/50mL N 20181231 70470-1809_3fa409d4-600b-4d5b-e054-00144ff8d46c 70470-1809 HUMAN OTC DRUG Menopause Care Synergy Menopause Care OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. SAGE OIL 3 mg/50mL N 20181231 70470-1813_62d272e2-2730-da97-e053-2a91aa0a9eb5 70470-1813 HUMAN OTC DRUG Storks Synergy for balance of uterus Storks Synergy OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. SAGE OIL .8 mg/50mL N 20191231 70470-1818_322c1d85-5961-23a8-e054-00144ff8d46c 70470-1818 HUMAN OTC DRUG Stretch Marks Remover Stretch Marks Remover cocoa butter OIL TOPICAL 20160401 OTC MONOGRAPH FINAL part346 PHYTOPIA CO., LTD. COCOA BUTTER 3.2 mg/50mL N 20181231 70470-8001_3219fdc1-0d92-261a-e054-00144ff88e88 70470-8001 HUMAN OTC DRUG Shaping without workout menthol OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. EUCALYPTOL; SAGE OIL 4.3; 3 mg/50mL; mg/50mL N 20181231 70470-8002_3219fdc1-0d93-261a-e054-00144ff88e88 70470-8002 HUMAN OTC DRUG Shaping with workout - loose skin revitalizer menthol OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. EUCALYPTOL; MENTHOL 7.3; .8 mg/50mL; mg/50mL N 20181231 70470-8003_31c5d8fa-6dbf-5060-e054-00144ff8d46c 70470-8003 HUMAN OTC DRUG Swelling Solution - improving lymphatic drainage peppermint OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. PEPPERMINT; SAGE OIL 13; 5.3 mg/50mL; mg/50mL N 20181231 70470-8004_3fa3bbf7-542e-6172-e054-00144ff88e88 70470-8004 HUMAN OTC DRUG Lactic Acid Free M Synergy for male Lactic Acid Free Male OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. MENTHOL .8 mg/50mL N 20181231 70470-8005_491cfed1-0102-2c58-e054-00144ff8d46c 70470-8005 HUMAN OTC DRUG Lactic Acid Free for sportswoman Synergy for female Lactic Acid Free Female OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. MENTHOL .8 mg/50mL N 20181231 70470-9013_30813eb1-9ed4-0f55-e054-00144ff8d46c 70470-9013 HUMAN OTC DRUG Slim Booster with natural slimming activators sage oil OIL TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part356 PHYTOPIA CO., LTD. SAGE OIL; EUCALYPTOL 4.3; 13 mg/50mL; mg/50mL N 20181231 70470-9901_46db88d4-4079-2fa5-e054-00144ff8d46c 70470-9901 HUMAN OTC DRUG Stress Relief Honzo Seika Chinese Herbal Aroma Oil Stress Relief OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER Phytopia Co., Ltd. ASIAN GINSENG 7 mg/100mL N 20181231 70470-9902_47f23135-e6bc-49e3-e054-00144ff8d46c 70470-9902 HUMAN OTC DRUG Lung Care Honzo Seika Chinese Herbal Aroma Oil Lung Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER Phytopia Co., Ltd. ANGELICA DAHURICA ROOT 33 mg/100mL N 20181231 70470-9903_47f23135-e6c6-49e3-e054-00144ff8d46c 70470-9903 HUMAN OTC DRUG Blood Care Honzo Seika Chinese Herbal Aroma Oil Blood Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER Phytopia Co., Ltd. ASIAN GINSENG; ANGELICA SINENSIS ROOT 8.5; 3 mg/100mL; mg/100mL N 20181231 70470-9904_47f0f54b-b4c0-45ef-e054-00144ff88e88 70470-9904 HUMAN OTC DRUG Slim Care Honzo Seika Chinese Herbal Aroma Oil Slim Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER Phytopia Co., Ltd. SCUTELLARIA LATERIFLORA 18 mg/100mL N 20181231 70470-9905_47f2325e-7bc7-66f1-e054-00144ff88e88 70470-9905 HUMAN OTC DRUG Breast Care Honzo Seika Chinese Herbal Aroma Oil Breast Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER Phytopia Co., Ltd. ANGELICA SINENSIS ROOT 12.5 mg/100mL N 20181231 70470-9906_47f23135-e6ee-49e3-e054-00144ff8d46c 70470-9906 HUMAN OTC DRUG Digestive Care Honzo Seika Chinese Herbal Aroma Oil Digestive Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER Phytopia Co., Ltd. PEPPERMINT 28 mg/100mL N 20181231 70470-9912_47f2b6b3-9ad2-03c2-e054-00144ff88e88 70470-9912 HUMAN OTC DRUG Female Care Honzo Seika Chinese Herbal Aroma Oil Female Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER Phytopia Co., Ltd. SALVIA MILTIORRHIZA ROOT 6 mg/100mL N 20181231 70470-9915_47f2ec96-3c9a-74f4-e054-00144ff88e88 70470-9915 HUMAN OTC DRUG Pain Relief Honzo Seika Chinese Herbal Aroma Oil Pain Relief OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER Phytopia Co., Ltd. GINGER 28 mg/100mL N 20181231 70470-9917_47f2ec96-3ca2-74f4-e054-00144ff88e88 70470-9917 HUMAN OTC DRUG Anti-Cellulite Honzo Seika Chinese Herbal Aroma Oil Anti-Cellulite OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER Phytopia Co., Ltd. ATRACTYLODES LANCEA ROOT OIL 15 mg/100mL N 20181231 70470-9931_47f3544a-6f92-0bd3-e054-00144ff8d46c 70470-9931 HUMAN OTC DRUG Liver Care Honzo Seika Chinese Herbal Aroma Oil Liver Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER Phytopia Co., Ltd. ASIAN GINSENG 46 mg/100mL N 20181231 70470-9951_4da49d31-5c20-71f7-e054-00144ff8d46c 70470-9951 HUMAN OTC DRUG BEAUTIFUL CONTRACT - Slimming contract Hui Ju Sheng Enterprise Corporation Ltd. BEAUTIFUL CONTRACT - Slimming contract CAPSULE, GELATIN COATED ORAL 20160401 UNAPPROVED HOMEOPATHIC Phytopia Co., Ltd. LEVOCARNITINE; LECITHIN, SOYBEAN 210; 36 mg/600mg; mg/600mg N 20181231 70470-9952_4da480c5-b2b7-65d7-e054-00144ff8d46c 70470-9952 HUMAN OTC DRUG BEAUTIFUL CONTRACT - Deep V Breast contract Hui Ju Sheng Enterprise Corporation Ltd. BEAUTIFUL CONTRACT - Deep V Breast contract CAPSULE, GELATIN COATED ORAL 20160401 UNAPPROVED HOMEOPATHIC Phytopia Co., Ltd. PAPAIN 35 mg/500mg N 20181231 70472-101_619a3982-a37f-7c26-e053-2991aa0a57ec 70472-101 HUMAN OTC DRUG TRISEPTIN ALCOHOL LOTION TOPICAL 20170915 OTC MONOGRAPH NOT FINAL part333E DFB Technology Ltd ALCOHOL .7 mL/mL N 20181231 70472-102_5902cc80-0f0c-95b8-e053-2991aa0a4862 70472-102 HUMAN OTC DRUG TRISEPTIN WATER AIDED ALCOHOL LOTION TOPICAL 20170825 OTC MONOGRAPH NOT FINAL part333E DFB Technology Ltd ALCOHOL .7 mL/mL N 20181231 70474-101_131ff8e6-55fa-4097-a65e-e87d368cf4fd 70474-101 HUMAN OTC DRUG DETOX AND PROTECT FOUNDATION SPF-15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20160407 OTC MONOGRAPH FINAL part352 ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS) OCTINOXATE; TITANIUM DIOXIDE .9; 12.2 g/100mL; g/100mL N 20181231 70474-102_38d4fc74-841d-4b06-a109-259d6821d0db 70474-102 HUMAN OTC DRUG MATTIFYING EXTREME WEAR FOUNDATION SPF-15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20160407 OTC MONOGRAPH FINAL part352 ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS) OCTINOXATE; TITANIUM DIOXIDE .9; 12.2 g/100mL; g/100mL N 20181231 70474-103_d4addbe0-a528-4fee-a15e-6738a8cc12b3 70474-103 HUMAN OTC DRUG REJUVENATING FOUNDATION SPF-15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20160407 OTC MONOGRAPH FINAL part352 ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS) OCTINOXATE; TITANIUM DIOXIDE .9; 12.2 g/100mL; g/100mL N 20181231 70474-104_b1458142-694d-48e4-b11f-cce040f6bae0 70474-104 HUMAN OTC DRUG LUMINOUS MOISTURIZING FOUNDATION SPF-15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20160407 OTC MONOGRAPH FINAL part352 ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS) OCTINOXATE; TITANIUM DIOXIDE .9; 12.2 g/100mL; g/100mL N 20181231 70474-110_85738471-94d0-4d11-bc15-8a1dabdc6ef9 70474-110 HUMAN OTC DRUG SUNGLOW FOUNDATION SPF-15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20160407 OTC MONOGRAPH FINAL part352 ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS) OCTINOXATE; TITANIUM DIOXIDE .9; 12.2 g/100mL; g/100mL N 20181231 70474-120_ea690de5-1c47-4e38-bb53-df4c3ac76579 70474-120 HUMAN OTC DRUG MINERAL FOUNDATION SPF-15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20160407 OTC MONOGRAPH FINAL part352 ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS) OCTINOXATE; TITANIUM DIOXIDE .9; 12.2 g/100mL; g/100mL N 20181231 70474-130_e28611fc-eb9c-42a8-97c2-b79c96fe746e 70474-130 HUMAN OTC DRUG BB SPF-15 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20160407 OTC MONOGRAPH FINAL part352 ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS) OCTINOXATE; TITANIUM DIOXIDE .9; 12.2 g/100mL; g/100mL N 20181231 70474-610_f1836195-3c02-481a-b49a-768689475def 70474-610 HUMAN OTC DRUG MINERAL CONCEALER SPF-15 OCTINOXATE, TITANIUM DIOXIDE LOTION TOPICAL 20160407 OTC MONOGRAPH FINAL part352 ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS) OCTINOXATE; TITANIUM DIOXIDE .9; 12.2 g/100mL; g/100mL N 20181231 70474-910_dd9f3ae3-b430-4330-adf2-d557f49d48e5 70474-910 HUMAN OTC DRUG BB CONCEALER SPF-15 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20160407 OTC MONOGRAPH FINAL part352 ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS) OCTINOXATE; TITANIUM DIOXIDE .9; 12.2 g/100mL; g/100mL N 20181231 70476-0002_e5c550dc-4e59-4583-922a-c88d7d101caf 70476-0002 HUMAN OTC DRUG Happy Happy Lithium Carbonicum, Aurum Metallicum, Serotonin (Hydrochloride) LIQUID ORAL 20180115 UNAPPROVED HOMEOPATHIC Holistic Haven LITHIUM CARBONATE; GOLD; SEROTONIN HYDROCHLORIDE 6; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 70476-0005_028e877b-5171-4735-8a80-10d1d07d6f07 70476-0005 HUMAN OTC DRUG Stay Well Echinacea Purpurea, Argentum Nitricum, Baptisia Tinctoria, Galium Aparine, Pulsatilla (Vulgaris), Thuja Occidentalis, Phosphorus, Thymus Serpyllum, Echinacea (Angustifolia), Sulphur LIQUID ORAL 20180119 UNAPPROVED HOMEOPATHIC Holistic Haven ECHINACEA PURPUREA; SILVER NITRATE; BAPTISIA TINCTORIA ROOT; GALIUM APARINE; ANEMONE PULSATILLA; THUJA OCCIDENTALIS LEAFY TWIG; PHOSPHORUS; THYMUS SERPYLLUM; ECHINACEA ANGUSTIFOLIA; SULFUR 3; 6; 6; 6; 6; 6; 6; 6; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 70476-0006_b0a4afe4-7f0d-4f2f-b2a2-5320d35c2a85 70476-0006 HUMAN OTC DRUG Stomach Relief Arsenicum Album, Carbo Vegetabilis, Nux Vomica, Robinia Pseudoacacia LIQUID ORAL 20180118 UNAPPROVED HOMEOPATHIC Holistic Haven ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; STRYCHNOS NUX-VOMICA SEED; ROBINIA PSEUDOACACIA BARK 30; 30; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20191231 70477-101_2adce835-2eb2-458c-8347-03ed93a85c48 70477-101 HUMAN OTC DRUG Therapytion Hair Tonic Salicylic Acid, Dexpanthenol LIQUID TOPICAL 20160229 UNAPPROVED DRUG OTHER 360 Perspective SALICYLIC ACID; DEXPANTHENOL .0025; .002 1/120mL; 1/120mL E 20171231 70477-102_d06f79db-deed-4fe3-96ec-389e281caf0f 70477-102 HUMAN OTC DRUG Theraphytion Nokmosu Panthenol, Salicylic Acid SHAMPOO TOPICAL 20160302 UNAPPROVED DRUG OTHER 360 Perspective PANTHENOL; SALICYLIC ACID .002; .0025 1/530g; 1/530g E 20171231 70477-103_0ea7e1e9-0b19-4243-8de4-100b017d6dff 70477-103 HUMAN OTC DRUG Therapytion Natural Relaxing Panthenol, Salicylic Acid, Niacinamide, Menthol SHAMPOO TOPICAL 20160420 UNAPPROVED DRUG OTHER 360 Perspective PANTHENOL; SALICYLIC ACID; NIACINAMIDE; MENTHOL .002; .002; .001; .001 1/500mL; 1/500mL; 1/500mL; 1/500mL E 20171231 70477-104_a14bbb7c-5803-440f-a1e2-7e2ea73235b4 70477-104 HUMAN OTC DRUG Therapytion Natural Deep Clean Panthenol, Salicylic Acid, Niacinamide, Menthol SHAMPOO TOPICAL 20160420 UNAPPROVED DRUG OTHER 360 Perspective PANTHENOL; SALICYLIC ACID; NIACINAMIDE; MENTHOL .002; .002; .001; .002 1/500mL; 1/500mL; 1/500mL; 1/500mL E 20171231 70481-001_382699c1-78a5-57fa-e054-00144ff88e88 70481-001 HUMAN OTC DRUG All Day Hand Sanitizer Benzalkonium chloride LIQUID TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part333E General Resources LLC BENZALKONIUM CHLORIDE .13 g/mL N 20181231 70481-011_382c0be9-b706-32fc-e054-00144ff88e88 70481-011 HUMAN OTC DRUG All Day Antimicrobial Cleansing Facial Foam and Mousse Benzalkonium chloride LIQUID TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part333E General Resources LLC BENZALKONIUM CHLORIDE .13 g/mL N 20181231 70481-021_382c4002-6354-2e85-e054-00144ff88e88 70481-021 HUMAN OTC DRUG All Day Antimicrobial Foot Cleanser Benzalkonium chloride LIQUID TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part333E General Resources LLC BENZALKONIUM CHLORIDE .13 g/mL N 20181231 70481-111_3ae520ab-ba47-09c2-e054-00144ff8d46c 70481-111 HUMAN OTC DRUG All Day Hand Sanitizer Ultra Ethanol LIQUID TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333E General Resources LLC ALCOHOL 720 g/L N 20181231 70482-085_fc8ae634-62f8-4ef2-b01b-4f6ff25b59b5 70482-085 HUMAN PRESCRIPTION DRUG GOCOVRI AMANTADINE CAPSULE, COATED PELLETS ORAL 20170824 NDA NDA208944 Adamas Pharma, LLC AMANTADINE 68.5 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 70482-170_fc8ae634-62f8-4ef2-b01b-4f6ff25b59b5 70482-170 HUMAN PRESCRIPTION DRUG GOCOVRI AMANTADINE CAPSULE, COATED PELLETS ORAL 20170824 NDA NDA208944 Adamas Pharma, LLC AMANTADINE 137 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 70483-001_337d9598-5d5c-3bb0-e054-00144ff8d46c 70483-001 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part333E Jean Pierre Inc. ALCOHOL 62 mL/100mL N 20181231 70483-001_33baa936-182e-620b-e054-00144ff88e88 70483-001 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part333E Jean Pierre Inc. ALCOHOL 62 mL/100mL N 20181231 70483-001_33baa936-1833-620b-e054-00144ff88e88 70483-001 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part333E Jean Pierre Inc. ALCOHOL 62 mL/100mL N 20181231 70483-001_33baa936-1839-620b-e054-00144ff88e88 70483-001 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part333E Jean Pierre Inc. ALCOHOL 62 mL/100mL N 20181231 70483-001_33bbfde8-902d-1ada-e054-00144ff8d46c 70483-001 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part333E Jean Pierre Inc. ALCOHOL 62 mL/100mL N 20181231 70483-001_33bbfde8-9034-1ada-e054-00144ff8d46c 70483-001 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part333E Jean Pierre Inc. ALCOHOL 62 mL/100mL N 20181231 70483-001_33d2a924-5c44-648b-e054-00144ff8d46c 70483-001 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part333E Jean Pierre Inc. ALCOHOL 62 mL/100mL N 20181231 70483-001_33d3abb1-1473-2f5b-e054-00144ff8d46c 70483-001 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part333E Jean Pierre Inc. ALCOHOL 62 mL/100mL N 20181231 70483-001_33d3abb1-1482-2f5b-e054-00144ff8d46c 70483-001 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part333E Jean Pierre Inc. ALCOHOL 62 mL/100mL N 20181231 70483-001_33d40a60-359c-4207-e054-00144ff8d46c 70483-001 HUMAN OTC DRUG Anti-Bacterial Hand Gel ETHYL ALCOHOL GEL TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part333E Jean Pierre Inc. ALCOHOL 62 mL/100mL N 20181231 70484-001_5e48a6a5-93f2-426e-8e7b-b141d57ba375 70484-001 HUMAN OTC DRUG Post peel Protectant Vitality Institute Hydrocortisone CREAM TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part348 Vi Medical Products Inc. HYDROCORTISONE 7.5 g/100mL N 20181231 70484-003_d98dc511-af44-460d-a06f-c0166a584482 70484-003 HUMAN OTC DRUG HQ Plus Brightening Cream VI Derm Hydroquinone CREAM TOPICAL 20160705 OTC MONOGRAPH NOT FINAL part358A Vi Medical Products Inc. HYDROQUINONE 2 g/50mL N 20181231 70484-004_e4421ac2-5daf-4afe-83c3-fc0e77ce2230 70484-004 HUMAN OTC DRUG HQ Plus Brightening Cream VI Derm Hydroquinone CREAM TOPICAL 20160705 OTC MONOGRAPH NOT FINAL part358A Vi Medical Products Inc. HYDROQUINONE 1 g/50mL N 20181231 70484-005_aba966b8-75ef-4f5d-a1e1-e4413571b739 70484-005 HUMAN OTC DRUG Sunscreen Broad Spectrum SPF 50 Vi Aesthetics Zinc Oxide, Octinoxate CREAM TOPICAL 20150326 OTC MONOGRAPH FINAL part352 Vi Medical Products, INC ZINC OXIDE; OCTINOXATE 10; 7.5 g/100mL; g/100mL N 20181231 70484-006_1383cc7f-239e-4ef0-8015-cce390318d8f 70484-006 HUMAN OTC DRUG Post peel Protectant Vitality Institute Hydrocortisone CREAM TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part348 Vi Medical Products Inc. HYDROCORTISONE 7.5 g/100mL N 20181231 70486-001_feae76b4-f590-46a4-9629-c1df7c2b40bf 70486-001 HUMAN PRESCRIPTION DRUG Chi-Myst Topical Chitosan ketorolac bupivacaine suspension SPRAY, METERED TOPICAL 20160819 UNAPPROVED DRUG OTHER Prescription Care LLC BUPIVACAINE HYDROCHLORIDE; KETOROLAC TROMETHAMINE; CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) .3; .3; .1 g/100mL; g/100mL; g/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 70486-003_2dd6b462-eb83-4761-92bc-1f1842427613 70486-003 HUMAN PRESCRIPTION DRUG Chi-Myst Topical Chitosan ketorolac bupivacaine suspension SPRAY, METERED TOPICAL 20160819 UNAPPROVED DRUG OTHER Prescription Care LLC BUPIVACAINE HYDROCHLORIDE; KETOROLAC TROMETHAMINE; CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) .09; .09; .03 g/30mL; g/30mL; g/30mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 70486-011_01be57c5-897d-45f5-982f-37518a4965a1 70486-011 HUMAN PRESCRIPTION DRUG Chi-Myst Resolve Topical Chitosan ketorolac bupivacaine lidocaine suspension SPRAY, METERED TOPICAL 20160601 UNAPPROVED DRUG OTHER Prescription Care LLC BUPIVACAINE HYDROCHLORIDE; KETOROLAC TROMETHAMINE; CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S); LIDOCAINE HYDROCHLORIDE .3; .3; .1; 5 g/100mL; g/100mL; g/100mL; g/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 70486-013_c4275aa2-f59e-4db2-b47a-8c68de1e3f55 70486-013 HUMAN PRESCRIPTION DRUG Chi-Myst Resolve Topical Chitosan ketorolac bupivacaine lidocaine suspension SPRAY, METERED TOPICAL 20160601 UNAPPROVED DRUG OTHER Prescription Care LLC BUPIVACAINE HYDROCHLORIDE; KETOROLAC TROMETHAMINE; CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S); LIDOCAINE HYDROCHLORIDE .09; .09; .03; 50 g/30mL; g/30mL; g/30mL; g/30mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 70486-030_8fb041d8-37dd-492d-93c1-36ac6ecf35fa 70486-030 HUMAN PRESCRIPTION DRUG Chi-Myst Synergy Topical Chitosan ketorolac bupivacaine lidocaine suspension SPRAY, METERED TOPICAL 20160601 UNAPPROVED DRUG OTHER Prescription Care LLC BUPIVACAINE HYDROCHLORIDE; KETOROLAC TROMETHAMINE; CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S); LIDOCAINE HYDROCHLORIDE .09; .45; .03; 1.5 g/30mL; g/30mL; g/30mL; g/30mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 70486-100_3587b10c-78be-4a41-8afa-c5faf59385fd 70486-100 HUMAN PRESCRIPTION DRUG Chi-Myst Synergy Topical Chitosan ketorolac bupivacaine lidocaine suspension SPRAY, METERED TOPICAL 20160601 UNAPPROVED DRUG OTHER Prescription Care LLC BUPIVACAINE HYDROCHLORIDE; KETOROLAC TROMETHAMINE; CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S); LIDOCAINE HYDROCHLORIDE .3; 1.5; .1; 5 g/100mL; g/100mL; g/100mL; g/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 70488-0001_451322d0-0f17-63b3-e054-00144ff8d46c 70488-0001 HUMAN OTC DRUG J9 ULTRA ADVANCED EYEBROW SERUM MENTHOL LIQUID TOPICAL 20160222 UNAPPROVED DRUG OTHER MUSEE Cosmetic Co.,Ltd. MENTHOL .1 g/100mL N 20181231 70488-0002_4513dfa4-89ed-2fec-e054-00144ff8d46c 70488-0002 HUMAN OTC DRUG J9 ULTRA ADVANCED INTENSIVE RECOVERY SERUM GLYCERIN LIQUID TOPICAL 20160222 OTC MONOGRAPH FINAL part347 MUSEE Cosmetic Co.,Ltd. GLYCERIN 2 g/100mL N 20181231 70488-0003_4513e1b6-8bad-2cfa-e054-00144ff8d46c 70488-0003 HUMAN OTC DRUG J9 ULTRA ADVANCED INTENSIVE RECOVERY DIMETHICONE SHAMPOO TOPICAL 20160222 OTC MONOGRAPH FINAL part347 MUSEE Cosmetic Co.,Ltd. DIMETHICONE 1 g/100mL N 20181231 70488-0004_4513dfa4-89f7-2fec-e054-00144ff8d46c 70488-0004 HUMAN OTC DRUG J9 ULTRA ADVANCED INTENSIVE SCALP SERUM MENTHOL LIQUID TOPICAL 20160222 UNAPPROVED DRUG OTHER MUSEE Cosmetic Co.,Ltd. MENTHOL .1 g/100mL N 20181231 70488-0005_4513dfa4-8a01-2fec-e054-00144ff8d46c 70488-0005 HUMAN OTC DRUG J9 ULTRA ADVANCED INTENSIVE SCALP Dimethicone SHAMPOO TOPICAL 20160222 OTC MONOGRAPH FINAL part347 MUSEE Cosmetic Co.,Ltd. DIMETHICONE 1.666667 g/100mL N 20181231 70488-0006_4513dfa4-8a0b-2fec-e054-00144ff8d46c 70488-0006 HUMAN OTC DRUG J9 ULTRA ADVANCED INTENSIVE SCALP TREATMENT Dimethicone LIQUID TOPICAL 20160222 OTC MONOGRAPH FINAL part347 MUSEE Cosmetic Co.,Ltd. DIMETHICONE 1 g/100mL N 20181231 70493-520_2c7c8d54-28c2-0179-e054-00144ff8d46c 70493-520 HUMAN OTC DRUG ETHYLHEXYL METHOXYCINNAMATE Cream Detoxifying Day Cream Regular CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 inspira: cosmeticsGmbH OCTINOXATE 2 g/50mL E 20171231 70493-521_2c7c5574-fc3f-5a4f-e054-00144ff8d46c 70493-521 HUMAN OTC DRUG Ethylhexyl Methoxycinnamate cream Detoxifying Day Cream Rich CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 inspira:cosmetics GmbH OCTINOXATE 2 g/50mL E 20171231 70493-560_2cb3e7f9-5c34-2c81-e054-00144ff8d46c 70493-560 HUMAN OTC DRUG ETHYLHEXYL METHOXYCINNAMATE Cream Beautiful Eyes Cream CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part352 inspira: cosmetics GmbH OCTINOXATE .6 g/15mL E 20171231 70495-021_630d9a3b-3a06-5c6e-e053-2991aa0a61bc 70495-021 HUMAN OTC DRUG Primer Broad Spectrum Sunscreen AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20160309 20180801 OTC MONOGRAPH NOT FINAL part352 Black Up sas AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 20; 45; 30; 40 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 70498-1100_320bb0bc-98bf-1028-e054-00144ff8d46c 70498-1100 HUMAN OTC DRUG Lil Goats Petite Chevre Fragrance free zinc oxide and kaolin OINTMENT TOPICAL 20160523 OTC MONOGRAPH FINAL part347 Produits De Soins Pour La Peau Au Lait De Chevre Canus Inc ZINC OXIDE; KAOLIN 250; 145 mg/g; mg/g N 20181231 70498-1150_320bb0bc-98bf-1028-e054-00144ff8d46c 70498-1150 HUMAN OTC DRUG Lil Goats Petite Chevre Original zinc oxide and kaolin OINTMENT TOPICAL 20160523 OTC MONOGRAPH FINAL part347 Produits De Soins Pour La Peau Au Lait De Chevre Canus Inc KAOLIN; ZINC OXIDE 145; 250 mg/g; mg/g N 20181231 70504-0051_3c1dd633-2fa9-45c3-ba7a-8771d5c3b5f1 70504-0051 HUMAN PRESCRIPTION DRUG HepaGam B Hepatitis B Immune Globulin (Human) INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160701 BLA BLA125035 Aptevo BioTherapeutics LLC HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU]/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] N 20181231 70504-0052_3c1dd633-2fa9-45c3-ba7a-8771d5c3b5f1 70504-0052 HUMAN PRESCRIPTION DRUG HepaGam B Hepatitis B Immune Globulin (Human) INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20160701 BLA BLA125035 Aptevo BioTherapeutics LLC HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU]/mL Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] N 20181231 70504-0126_097e23f2-3e24-41cd-b2f8-410b2db147b4 70504-0126 HUMAN PRESCRIPTION DRUG VARIZIG Varicella Zoster Immune Globulin (Human) SOLUTION INTRAMUSCULAR 20160701 BLA BLA125430 Aptevo BioTherapeutics LLC HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN 125 [iU]/1 N 20181231 70504-0282_b77eca7a-ff73-4c6f-a664-8145c640515d 70504-0282 HUMAN PRESCRIPTION DRUG Ixinity coagulation factor IX (recombinant) KIT 20170512 BLA BLA125426 Aptevo BioTherapeutics LLC N 20181231 70504-0283_b77eca7a-ff73-4c6f-a664-8145c640515d 70504-0283 HUMAN PRESCRIPTION DRUG Ixinity coagulation factor IX (recombinant) KIT 20170512 BLA BLA125426 Aptevo BioTherapeutics LLC N 20181231 70504-0284_b77eca7a-ff73-4c6f-a664-8145c640515d 70504-0284 HUMAN PRESCRIPTION DRUG Ixinity coagulation factor IX (recombinant) KIT 20170512 BLA BLA125426 Aptevo BioTherapeutics LLC N 20181231 70504-0285_b77eca7a-ff73-4c6f-a664-8145c640515d 70504-0285 HUMAN PRESCRIPTION DRUG Ixinity coagulation factor IX (recombinant) KIT 20170512 BLA BLA125426 Aptevo BioTherapeutics LLC N 20181231 70504-0286_b77eca7a-ff73-4c6f-a664-8145c640515d 70504-0286 HUMAN PRESCRIPTION DRUG Ixinity coagulation factor IX (recombinant) KIT 20170512 BLA BLA125426 Aptevo BioTherapeutics LLC N 20181231 70504-0287_b77eca7a-ff73-4c6f-a664-8145c640515d 70504-0287 HUMAN PRESCRIPTION DRUG Ixinity coagulation factor IX (recombinant) KIT 20170512 BLA BLA125426 Aptevo BioTherapeutics LLC N 20181231 70504-0288_b77eca7a-ff73-4c6f-a664-8145c640515d 70504-0288 HUMAN PRESCRIPTION DRUG Ixinity coagulation factor IX (recombinant) KIT 20170512 BLA BLA125426 Aptevo BioTherapeutics LLC N 20181231 70504-0289_b77eca7a-ff73-4c6f-a664-8145c640515d 70504-0289 HUMAN PRESCRIPTION DRUG Ixinity coagulation factor IX (recombinant) KIT 20170512 BLA BLA125426 Aptevo BioTherapeutics LLC N 20181231 70504-3000_b95c6817-f514-45f0-9092-24a7462355b4 70504-3000 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20160701 BLA BLA103649 Aptevo BioTherapeutics LLC HUMAN IMMUNOGLOBULIN G 15000 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 70504-3100_b95c6817-f514-45f0-9092-24a7462355b4 70504-3100 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20160701 BLA BLA103649 Aptevo BioTherapeutics LLC HUMAN IMMUNOGLOBULIN G 5000 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 70504-3300_b95c6817-f514-45f0-9092-24a7462355b4 70504-3300 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20160701 BLA BLA103649 Aptevo BioTherapeutics LLC HUMAN IMMUNOGLOBULIN G 1500 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 70504-3500_b95c6817-f514-45f0-9092-24a7462355b4 70504-3500 HUMAN PRESCRIPTION DRUG WINRHO rho (d) immune globulin LIQUID INTRAMUSCULAR; INTRAVENOUS 20160701 BLA BLA103649 Aptevo BioTherapeutics LLC HUMAN IMMUNOGLOBULIN G 2500 [iU]/mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 70506-010_8ed13f7e-30d3-4980-b0b4-d5795d03bc5b 70506-010 HUMAN OTC DRUG Cellpium Shinyline Glycerin CREAM TOPICAL 20160201 UNAPPROVED DRUG OTHER MEDIPOST Co.,Ltd. GLYCERIN 12.9 g/150mL N 20181231 70506-020_3bac4e08-0492-4412-8d00-7c2199c4bc27 70506-020 HUMAN OTC DRUG CELLPIUM REAL MASK PACK Niacinamide PATCH TOPICAL 20160201 UNAPPROVED DRUG OTHER MEDIPOST Co.,Ltd. NIACINAMIDE .46 g/31 N 20181231 70506-030_f3eebb85-fe84-4b28-87c2-a56d3595fdf8 70506-030 HUMAN OTC DRUG Cellpium vampire cleansing mask Allantoin PATCH TOPICAL 20160201 UNAPPROVED DRUG OTHER MEDIPOST Co.,Ltd. ALLANTOIN .06 g/51 N 20181231 70506-040_684f35e4-ae02-49aa-b5bc-554d87e455c4 70506-040 HUMAN OTC DRUG Cellpium rich body Dimethicone CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part347 MEDIPOST Co.,Ltd. DIMETHICONE 10.04 g/200mL N 20181231 70506-050_81fea68e-e2bb-48d7-b45a-4f5506490cfc 70506-050 HUMAN OTC DRUG Cellpium rich body GLYCERIN LOTION TOPICAL 20160201 UNAPPROVED DRUG OTHER MEDIPOST Co.,Ltd. GLYCERIN 32.12 g/400mL N 20181231 70506-060_540c47e8-d9ab-41ea-b18c-89c955af42de 70506-060 HUMAN OTC DRUG Cellpium blossom hand SHEA BUTTER CREAM TOPICAL 20160201 UNAPPROVED DRUG OTHER MEDIPOST Co.,Ltd. SHEA BUTTER 10.01 g/50mL N 20181231 70506-070_3d4be8ba-1356-4351-ab34-1707e0508126 70506-070 HUMAN OTC DRUG Cellpium super ultra DIMETHICONE CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part347 MEDIPOST Co.,Ltd. DIMETHICONE 2.3 g/50mL N 20181231 70506-080_73cc2bc1-4a76-4277-897c-8189acf2a632 70506-080 HUMAN OTC DRUG Cellpium double essence toner NIACINAMIDE LIQUID TOPICAL 20160201 UNAPPROVED DRUG OTHER MEDIPOST Co.,Ltd. NIACINAMIDE 2.6 g/130mL N 20181231 70506-090_fb0ad2d5-bd80-45ac-8319-039e63572cc1 70506-090 HUMAN OTC DRUG Cellpium super richness ampoule NIACINAMIDE GEL TOPICAL 20160201 UNAPPROVED DRUG OTHER MEDIPOST Co.,Ltd. NIACINAMIDE .3 g/21 N 20181231 70506-100_b1ba6447-547d-4e4a-88a5-e12c0c7d4e1d 70506-100 HUMAN OTC DRUG Cellpium super anti wrinkle serum DIMETHICONE CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part347 MEDIPOST Co.,Ltd. DIMETHICONE .9 g/30mL N 20181231 70506-110_0727c5b6-39e6-4aec-89c8-369c1f95bf5c 70506-110 HUMAN OTC DRUG Cellpium shield sun bb TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20160201 OTC MONOGRAPH NOT FINAL part352 MEDIPOST Co.,Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 5.5; 3.25; 2; 1.95 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 70506-120_0634ead6-fed6-45cb-9146-4e5771459c4b 70506-120 HUMAN OTC DRUG Celonia CM NIACINAMIDE SOLUTION TOPICAL 20160201 UNAPPROVED DRUG OTHER MEDIPOST Co.,Ltd. NIACINAMIDE .05 g/51 N 20181231 70506-130_49de873c-614f-4288-bdf7-2ac55334904f 70506-130 HUMAN OTC DRUG Cellpium premiumEX hybrid essence NIACINAMIDE CREAM TOPICAL 20160201 UNAPPROVED DRUG OTHER MEDIPOST Co.,Ltd. NIACINAMIDE 1 g/50mL N 20181231 70506-140_07104405-8365-4015-9981-450d143a659c 70506-140 HUMAN OTC DRUG Cellpium premiumEX hybrid toner NIACINAMIDE LIQUID TOPICAL 20160201 UNAPPROVED DRUG OTHER MEDIPOST Co.,Ltd. NIACINAMIDE 2.4 g/120mL N 20181231 70506-150_13a613fe-44b3-4ad4-8744-9201b9d50d7a 70506-150 HUMAN OTC DRUG Cellpium preamiumEX hybrid eye contour DIMETHICONE CREAM TOPICAL 20160102 OTC MONOGRAPH FINAL part347 MEDIPOST Co.,Ltd. DIMETHICONE .9 g/35mL N 20181231 70506-160_f49f9244-4317-4ccd-bd91-e985510f8aef 70506-160 HUMAN OTC DRUG Cellpium premiumEX hybrid yoon DIMETHICONE CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part347 MEDIPOST Co.,Ltd. DIMETHICONE 1.14 g/55mL N 20181231 70507-001_0792b523-589f-4ee7-9577-c01f35ebf204 70507-001 HUMAN OTC DRUG Full Hair Solution Salicylic Acid LIQUID TOPICAL 20160516 OTC MONOGRAPH FINAL part358H Sheen Lung Skin Care & Cosmetics Co.; Ltd SALICYLIC ACID .2 g/100mL E 20171231 70508-1601_30da41fb-5dd5-5899-e054-00144ff88e88 70508-1601 HUMAN OTC DRUG NasoxinSpray sodium chloride spray SPRAY NASAL 20160404 OTC MONOGRAPH FINAL part349 FRIANA LLC SODIUM CHLORIDE 1.2 mg/10mL E 20171231 70510-2171_3ec9b66c-7b4f-4909-9617-a741a2753ad8 70510-2171 HUMAN PRESCRIPTION DRUG RADICAVA edaravone INJECTION INTRAVENOUS 20170505 NDA NDA209176 Mitsubishi Tanabe Pharma America, Inc. EDARAVONE 30 mg/100mL N 20181231 70511-101_35351089-b792-4444-942f-9ab0852831ea 70511-101 HUMAN PRESCRIPTION DRUG SODIUM PHENYLACETATE AND SODIUM BENZOATE sodium phenylacetate and sodium benzoate INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20170522 ANDA ANDA208521 MAIA PHARMACEUTICALS, INC SODIUM PHENYLACETATE; SODIUM BENZOATE 100; 100 mg/mL; mg/mL Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 70512-025_5e1f20e0-4744-fc3c-e053-2991aa0aa7ad 70512-025 HUMAN PRESCRIPTION DRUG Diclofenac Sodium 1.5% Diclofenac Sodium Topical Solution SOLUTION TOPICAL 20171120 ANDA ANDA202769 KBS Solutions LLC DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70512-026_5e1ebcbf-3274-79bf-e053-2991aa0a7829 70512-026 HUMAN PRESCRIPTION DRUG Lidocaine 5% Lidocaine 5% cream OINTMENT TOPICAL 20171116 ANDA ANDA205318 KBS Solutions, LLC LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 70513-001_8be6216c-6329-4da4-903e-398ca13d69f4 70513-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20151227 NDA NDA205767 MedCare Equipment Company, LLC OXYGEN 990 mL/L N 20181231 70514-0001_5f2e1a9c-6798-02ef-e053-2a91aa0ab806 70514-0001 HUMAN OTC DRUG Pearl ReWhite Transfusion DNA Kit Glycerin LIQUID TOPICAL 20171129 OTC MONOGRAPH NOT FINAL part347 Karatica Co., Ltd GLYCERIN 5 g/100mL N 20181231 70514-0002_5f2e1a9c-67a5-02ef-e053-2a91aa0ab806 70514-0002 HUMAN OTC DRUG Saphire ReHydro Transfusion DNA Kit Glycerin LIQUID TOPICAL 20171129 OTC MONOGRAPH NOT FINAL part347 Karatica Co., Ltd GLYCERIN 4 g/100mL N 20181231 70514-0003_5fa4db80-455e-48f5-e053-2a91aa0aae17 70514-0003 HUMAN OTC DRUG Amethyst ReElastic Transfusion DNA Kit Glycerin LIQUID TOPICAL 20171205 OTC MONOGRAPH NOT FINAL part347 Karatica Co., Ltd GLYCERIN 5 g/100mL N 20181231 70514-0004_5fa52bbd-f340-2501-e053-2a91aa0a3f94 70514-0004 HUMAN OTC DRUG Ruby ReBorn Transfusion DNA Kit Glycerin LIQUID TOPICAL 20171129 OTC MONOGRAPH NOT FINAL part347 Karatica Co., Ltd GLYCERIN 7 g/100mL N 20181231 70514-0005_5fa52bbd-f345-2501-e053-2a91aa0a3f94 70514-0005 HUMAN OTC DRUG Tourmaline Relief Transfusion DNA Kit Glycerin LIQUID TOPICAL 20171205 OTC MONOGRAPH NOT FINAL part347 Karatica Co., Ltd GLYCERIN 7 g/100mL N 20181231 70514-0006_5fc9e431-a54f-d5ef-e053-2a91aa0a6ea4 70514-0006 HUMAN OTC DRUG Bio DNA Serum Glycerin LIQUID TOPICAL 20171129 OTC MONOGRAPH NOT FINAL part347 Karatica Co., Ltd GLYCERIN 10.82 g/100mL N 20181231 70514-0007_5fcaad2f-300d-058e-e053-2991aa0aa0ea 70514-0007 HUMAN OTC DRUG GOLD DUCKS EGG GDII Glycerin CREAM TOPICAL 20171129 OTC MONOGRAPH NOT FINAL part347 Karatica Co., Ltd GLYCERIN 10.20052486 g/100g N 20181231 70514-0008_5fcab6cf-0cf8-13df-e053-2991aa0afa02 70514-0008 HUMAN OTC DRUG DUCKS EGG GDII FOIL MASK Glycerin LIQUID TOPICAL 20171129 OTC MONOGRAPH NOT FINAL part347 Karatica Co., Ltd GLYCERIN 10 g/100mL N 20181231 70514-0009_5fcb9d13-4ef4-2b56-e053-2a91aa0a5f39 70514-0009 HUMAN OTC DRUG Im Fill Hyaluronic Acid PATCH TOPICAL 20171129 UNAPPROVED DRUG OTHER Karatica Co., Ltd HYALURONATE SODIUM 99.97 g/100g N 20181231 70514-0010_5fcc38b0-69f3-2919-e053-2991aa0ac673 70514-0010 HUMAN OTC DRUG DNA COUPLE MASK Glycerin LIQUID TOPICAL 20171129 OTC MONOGRAPH NOT FINAL part347 Karatica Co., Ltd GLYCERIN 10.01 g/100mL N 20181231 70515-105_afce2787-8899-4098-87c8-f1e8dd19e6dd 70515-105 HUMAN PRESCRIPTION DRUG BETAPACE sotalol hydrochloride TABLET ORAL 20160901 NDA NDA019865 Covis Pharma SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 70515-106_afce2787-8899-4098-87c8-f1e8dd19e6dd 70515-106 HUMAN PRESCRIPTION DRUG BETAPACE sotalol hydrochloride TABLET ORAL 20160901 NDA NDA019865 Covis Pharma SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 70515-109_afce2787-8899-4098-87c8-f1e8dd19e6dd 70515-109 HUMAN PRESCRIPTION DRUG BETAPACE sotalol hydrochloride TABLET ORAL 20160901 NDA NDA019865 Covis Pharma SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 70515-115_afce2787-8899-4098-87c8-f1e8dd19e6dd 70515-115 HUMAN PRESCRIPTION DRUG BETAPACE AF sotalol hydrochloride TABLET ORAL 20160901 NDA NDA021151 Covis Pharma SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 70515-116_afce2787-8899-4098-87c8-f1e8dd19e6dd 70515-116 HUMAN PRESCRIPTION DRUG BETAPACE AF sotalol hydrochloride TABLET ORAL 20160901 NDA NDA021151 Covis Pharma SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 70515-119_afce2787-8899-4098-87c8-f1e8dd19e6dd 70515-119 HUMAN PRESCRIPTION DRUG BETAPACE AF sotalol hydrochloride TABLET ORAL 20160901 NDA NDA021151 Covis Pharma SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 70515-260_9ec84cac-6ecc-43dc-8006-6ccc029e2707 70515-260 HUMAN PRESCRIPTION DRUG LANOXIN digoxin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170915 NDA NDA009330 Covis Pharma DIGOXIN 250 ug/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 70515-262_9ec84cac-6ecc-43dc-8006-6ccc029e2707 70515-262 HUMAN PRESCRIPTION DRUG LANOXIN digoxin INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170915 NDA NDA009330 Covis Pharma DIGOXIN 100 ug/mL Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 70515-500_c5bb62b8-1488-4330-a4b2-5d8d569f8d6a 70515-500 HUMAN PRESCRIPTION DRUG Sular nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170203 NDA NDA020356 Covis Pharma NISOLDIPINE 8.5 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 70515-501_c5bb62b8-1488-4330-a4b2-5d8d569f8d6a 70515-501 HUMAN PRESCRIPTION DRUG Sular nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170203 NDA NDA020356 Covis Pharma NISOLDIPINE 17 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 70515-503_c5bb62b8-1488-4330-a4b2-5d8d569f8d6a 70515-503 HUMAN PRESCRIPTION DRUG Sular nisoldipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170203 NDA NDA020356 Covis Pharma NISOLDIPINE 34 mg/1 Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Calcium Channel Antagonists [MoA],Decreased Blood Pressure [PE] N 20181231 70515-610_b6761f84-53ac-4745-a8c8-1e5427d7e179 70515-610 HUMAN PRESCRIPTION DRUG Prilosec omeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20170825 NDA NDA022056 Covis Pharma OMEPRAZOLE MAGNESIUM 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70515-625_b6761f84-53ac-4745-a8c8-1e5427d7e179 70515-625 HUMAN PRESCRIPTION DRUG Prilosec omeprazole magnesium GRANULE, DELAYED RELEASE ORAL 20170825 NDA NDA022056 Covis Pharma OMEPRAZOLE MAGNESIUM 2.5 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70515-628_76641b31-733a-4513-828b-22b520666b08 70515-628 HUMAN PRESCRIPTION DRUG Altoprev lovastatin TABLET, EXTENDED RELEASE ORAL 20160501 NDA NDA021316 Covis Pharma LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70515-629_76641b31-733a-4513-828b-22b520666b08 70515-629 HUMAN PRESCRIPTION DRUG Altoprev lovastatin TABLET, EXTENDED RELEASE ORAL 20160501 NDA NDA021316 Covis Pharma LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70515-630_76641b31-733a-4513-828b-22b520666b08 70515-630 HUMAN PRESCRIPTION DRUG Altoprev lovastatin TABLET, EXTENDED RELEASE ORAL 20160501 NDA NDA021316 Covis Pharma LOVASTATIN 60 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70515-700_6ddc26d7-a6fe-46dd-8b49-c55aa111f83e 70515-700 HUMAN PRESCRIPTION DRUG Rilutek riluzole TABLET ORAL 20160801 NDA NDA020599 Covis Pharma RILUZOLE 50 mg/1 Benzothiazole [EPC],Benzothiazoles [Chemical/Ingredient] N 20181231 70518-0000_3556a62b-4828-3f25-e054-00144ff88e88 70518-0000 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20160609 ANDA ANDA074112 REMEDYREPACK INC. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 70518-0001_50731060-d3e0-3c5c-e054-00144ff8d46c 70518-0001 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20161012 ANDA ANDA077783 REMEDYREPACK INC. LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 70518-0002_5ae9edbe-c59a-425d-e053-2991aa0a0112 70518-0002 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20161116 ANDA ANDA079170 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0003_5ae9edbe-c5d5-425d-e053-2991aa0a0112 70518-0003 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20161123 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0004_61e61460-ec0a-9a92-e053-2a91aa0a76aa 70518-0004 HUMAN PRESCRIPTION DRUG Ranitidine Immediate release Ranitidine TABLET ORAL 20161123 ANDA ANDA205512 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 70518-0005_4f1dfa5f-f3c0-4ae2-e054-00144ff8d46c 70518-0005 HUMAN PRESCRIPTION DRUG IBUPROFEN IBUPROFEN TABLET, FILM COATED ORAL 20161117 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0006_41db1bf8-96fd-3f76-e054-00144ff8d46c 70518-0006 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20161117 ANDA ANDA040903 REMEDYREPACK INC. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] E 20171231 70518-0007_5ae9edbe-c688-425d-e053-2991aa0a0112 70518-0007 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20161123 ANDA ANDA078423 REMEDYREPACK INC. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 70518-0008_47e6b593-844e-4f78-e054-00144ff8d46c 70518-0008 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20161118 ANDA ANDA040682 REMEDYREPACK INC. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 70518-0009_5aec2601-bd88-74bb-e053-2a91aa0adfba 70518-0009 HUMAN PRESCRIPTION DRUG isosorbide mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20161129 ANDA ANDA075155 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 70518-0010_49c65fea-994b-0eef-e054-00144ff88e88 70518-0010 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20161121 ANDA ANDA076639 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 70518-0011_41daf24d-4a93-0f9d-e054-00144ff8d46c 70518-0011 HUMAN OTC DRUG Guaifenesin and pseudoephedrine hydrochloride Extended Release Guaifenesin, pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE ORAL 20161121 ANDA ANDA091071 REMEDYREPACK INC. GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 E 20171231 70518-0012_575ece10-b445-68ad-e053-2a91aa0a2276 70518-0012 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20161122 ANDA ANDA090074 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 70518-0013_5aec2601-bda9-74bb-e053-2a91aa0adfba 70518-0013 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20161125 ANDA ANDA070027 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 70518-0014_5aec2601-bddb-74bb-e053-2a91aa0adfba 70518-0014 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20161130 ANDA ANDA071322 REMEDYREPACK INC. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0015_42a2192b-1083-0f9d-e054-00144ff8d46c 70518-0015 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20161123 ANDA ANDA084769 REMEDYREPACK INC. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 70518-0016_5aec2601-be08-74bb-e053-2a91aa0adfba 70518-0016 HUMAN PRESCRIPTION DRUG Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride TABLET, SUGAR COATED ORAL 20161128 ANDA ANDA084113 REMEDYREPACK INC. CHLORPROMAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0017_55a5f82f-cc9f-41f6-e054-00144ff88e88 70518-0017 HUMAN PRESCRIPTION DRUG Ranitidine Immediate release Ranitidine TABLET ORAL 20161125 ANDA ANDA205512 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70518-0018_42659400-c3f7-1b29-e054-00144ff8d46c 70518-0018 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20161128 ANDA ANDA204314 REMEDYREPACK INC. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 70518-0019_4264b751-856b-5461-e054-00144ff88e88 70518-0019 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20161128 ANDA ANDA074388 REMEDYREPACK INC. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 70518-0020_62d941be-0f68-980c-e053-2a91aa0a624a 70518-0020 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20161129 ANDA ANDA090617 REMEDYREPACK INC. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 70518-0021_4303b1e1-ef93-5773-e054-00144ff8d46c 70518-0021 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON TABLET, FILM COATED ORAL 20161129 ANDA ANDA077851 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 70518-0022_5aec2601-be50-74bb-e053-2a91aa0adfba 70518-0022 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20161208 ANDA ANDA070217 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0023_42a0d12f-4843-4cbf-e054-00144ff8d46c 70518-0023 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20161130 ANDA ANDA070278 REMEDYREPACK INC. HALOPERIDOL 10 mg/1 Typical Antipsychotic [EPC] E 20171231 70518-0024_42a0d12f-4816-4cbf-e054-00144ff8d46c 70518-0024 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20161130 ANDA ANDA040489 REMEDYREPACK INC. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 70518-0025_5b279cb7-1366-6a47-e053-2991aa0acd53 70518-0025 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20161205 ANDA ANDA076900 REMEDYREPACK INC. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0026_5b279cb7-139c-6a47-e053-2991aa0acd53 70518-0026 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET ORAL 20161205 ANDA ANDA091038 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0027_42a02b2a-b518-25a4-e054-00144ff88e88 70518-0027 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride labetalol hydrochloride TABLET ORAL 20161130 NDA NDA018716 REMEDYREPACK INC. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 70518-0028_42a0d12f-48c7-4cbf-e054-00144ff8d46c 70518-0028 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20161201 ANDA ANDA075483 REMEDYREPACK INC. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 70518-0029_4f1dccbe-f6fb-0563-e054-00144ff88e88 70518-0029 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20161201 ANDA ANDA074305 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0030_42a0d12f-480a-4cbf-e054-00144ff8d46c 70518-0030 HUMAN OTC DRUG ASPIRIN ASPIRIN TABLET, COATED ORAL 20161201 OTC MONOGRAPH NOT FINAL part343 REMEDYREPACK INC. ASPIRIN 325 mg/1 E 20171231 70518-0031_5b27dad8-ace9-3b26-e053-2a91aa0ae798 70518-0031 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20161208 ANDA ANDA077927 REMEDYREPACK INC. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0032_5b284733-61d3-d2c1-e053-2991aa0abdc8 70518-0032 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20161202 ANDA ANDA204597 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0033_43048cc4-fc6b-114a-e054-00144ff8d46c 70518-0033 HUMAN PRESCRIPTION DRUG ALENDRONATE SODIUM Alendronate sodium TABLET ORAL 20161201 ANDA ANDA076768 REMEDYREPACK INC. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] E 20171231 70518-0034_4304d154-6f77-6dad-e054-00144ff88e88 70518-0034 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20161202 ANDA ANDA075967 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 70518-0035_5c420075-429d-05ce-e053-2991aa0a7884 70518-0035 HUMAN PRESCRIPTION DRUG Haloperidol HALOPERIDOL LACTATE INJECTION, SOLUTION INTRAMUSCULAR 20161208 ANDA ANDA075689 REMEDYREPACK INC. HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20181231 70518-0036_5c67e199-8029-da16-e053-2a91aa0ac052 70518-0036 HUMAN PRESCRIPTION DRUG Lipitor atorvastatin calcium TABLET, FILM COATED ORAL 20161205 NDA NDA020702 REMEDYREPACK INC. ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0037_5ccdbf96-b4e6-6b04-e053-2a91aa0ac79c 70518-0037 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20161205 ANDA ANDA077863 REMEDYREPACK INC. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0038_5c68494f-722b-4682-e053-2a91aa0af951 70518-0038 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET ORAL 20161205 ANDA ANDA091605 REMEDYREPACK INC. DOXYCYCLINE 100 mg/1 N 20181231 70518-0039_5c7ac3e7-a6af-e8da-e053-2a91aa0a0e87 70518-0039 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20161207 ANDA ANDA077927 REMEDYREPACK INC. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0040_5c7addde-9b4e-de7c-e053-2991aa0a946d 70518-0040 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20161209 ANDA ANDA074185 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70518-0041_61e5f282-77a1-63e9-e053-2a91aa0a14b2 70518-0041 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan Succinate TABLET ORAL 20161207 ANDA ANDA078327 REMEDYREPACK INC. SUMATRIPTAN SUCCINATE 50 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20191231 70518-0042_5cddbfb3-f069-1c02-e053-2991aa0a7cd4 70518-0042 HUMAN PRESCRIPTION DRUG ondansetron ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20161206 ANDA ANDA077557 REMEDYREPACK INC. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 70518-0043_43048cc4-fc25-114a-e054-00144ff8d46c 70518-0043 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20161206 ANDA ANDA040749 REMEDYREPACK INC. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 70518-0044_5037eddb-ebd9-5956-e054-00144ff88e88 70518-0044 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE ORAL 20161207 ANDA ANDA203636 REMEDYREPACK INC. ESOMEPRAZOLE MAGNESIUM 40 1/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0045_432f5caa-4d5d-6eeb-e054-00144ff8d46c 70518-0045 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20161207 ANDA ANDA075657 REMEDYREPACK INC. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 70518-0046_432f5caa-4d24-6eeb-e054-00144ff8d46c 70518-0046 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20161208 ANDA ANDA075483 REMEDYREPACK INC. ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] E 20171231 70518-0047_5c7b4967-9298-1f7a-e053-2a91aa0a7a90 70518-0047 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20161230 ANDA ANDA202554 REMEDYREPACK INC. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0048_575f659c-29cb-f216-e053-2991aa0a2bba 70518-0048 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20161209 ANDA ANDA074754 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 70518-0049_43458af1-ffbd-3f4a-e054-00144ff88e88 70518-0049 HUMAN PRESCRIPTION DRUG LAMICTAL lamotrigine TABLET ORAL 20161209 NDA NDA020241 REMEDYREPACK INC. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 70518-0050_4780d2d6-8efb-0ba0-e054-00144ff8d46c 70518-0050 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20161212 ANDA ANDA077293 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70518-0051_437cc2e3-e65a-0447-e054-00144ff8d46c 70518-0051 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20161212 ANDA ANDA065028 REMEDYREPACK INC. RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] E 20171231 70518-0052_6272aa69-9526-0a28-e053-2a91aa0a22cc 70518-0052 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20161212 ANDA ANDA073192 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20191231 70518-0053_5c8ed986-ffe4-49f2-e053-2a91aa0a2ae9 70518-0053 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20161214 ANDA ANDA090858 REMEDYREPACK INC. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0054_5424fab4-e4e3-4649-e054-00144ff88e88 70518-0054 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20161212 ANDA ANDA076003 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 70518-0055_439252c1-3c5f-37bb-e054-00144ff8d46c 70518-0055 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20161212 ANDA ANDA063181 REMEDYREPACK INC. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] E 20171231 70518-0056_530c29e4-4674-7039-e054-00144ff88e88 70518-0056 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20161213 ANDA ANDA075576 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0057_43923620-9899-0486-e054-00144ff88e88 70518-0057 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20161213 NDA NDA019123 REMEDYREPACK INC. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 70518-0058_51e2b7b6-8d4d-421c-e054-00144ff8d46c 70518-0058 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20161213 ANDA ANDA203458 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 70518-0059_43a619f3-89a4-0cfc-e054-00144ff88e88 70518-0059 HUMAN PRESCRIPTION DRUG Caziant Triphasic Regimen Desogestrel and Ethinyl Estradiol KIT 20161213 ANDA ANDA076455 REMEDYREPACK INC. N 20181231 70518-0060_45744e86-ed25-6c61-e054-00144ff8d46c 70518-0060 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20161213 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0061_4435ae12-50ce-0c47-e054-00144ff88e88 70518-0061 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20161213 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 70518-0062_43923620-986e-0486-e054-00144ff88e88 70518-0062 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20161213 ANDA ANDA089686 REMEDYREPACK INC. PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 70518-0063_43a60039-1c38-10de-e054-00144ff8d46c 70518-0063 HUMAN PRESCRIPTION DRUG Isosorbide Dinitrate Isosorbide Dinitrate TABLET ORAL 20161214 ANDA ANDA086223 REMEDYREPACK INC. ISOSORBIDE DINITRATE 10 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 70518-0064_46cbd5ae-efd4-5e2d-e054-00144ff8d46c 70518-0064 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20161214 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0065_44bef09e-63f9-4a51-e054-00144ff88e88 70518-0065 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20161214 ANDA ANDA074556 REMEDYREPACK INC. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 70518-0066_4f5e7c28-6eba-1511-e054-00144ff88e88 70518-0066 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20161214 ANDA ANDA076899 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 70518-0068_616d6c88-844a-6621-e053-2a91aa0ad407 70518-0068 HUMAN OTC DRUG Biofreeze Roll-On MENTHOL GEL TOPICAL 20161215 OTC MONOGRAPH NOT FINAL part348 REMEDYREPACK INC. MENTHOL 40 mg/mL N 20181231 70518-0069_5c8ef38e-77b0-f831-e053-2a91aa0a3841 70518-0069 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20161216 ANDA ANDA202223 REMEDYREPACK INC. VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0070_4bea46c7-0514-5709-e054-00144ff88e88 70518-0070 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20161216 ANDA ANDA078216 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0071_5ac5274b-8bd7-0730-e053-2a91aa0aae64 70518-0071 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20161219 ANDA ANDA090564 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0072_45740bf0-f64f-41fa-e054-00144ff8d46c 70518-0072 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride Loperamide Hydrochloride CAPSULE ORAL 20161219 ANDA ANDA073192 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 70518-0073_4952b3fb-e8db-1dcd-e054-00144ff8d46c 70518-0073 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20161220 ANDA ANDA085162 REMEDYREPACK INC. PREDNISONE 10 mg/1 N 20181231 70518-0074_4432fc60-e53a-3162-e054-00144ff88e88 70518-0074 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20161221 ANDA ANDA075317 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 70518-0075_44d411ab-2cbd-3345-e054-00144ff88e88 70518-0075 HUMAN PRESCRIPTION DRUG KENALOG-40 TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20161221 NDA NDA014901 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] E 20171231 70518-0076_5c8f87a2-0aac-193e-e053-2a91aa0a5911 70518-0076 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20161222 ANDA ANDA076048 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0077_5c8f66b9-28f1-7282-e053-2a91aa0a3584 70518-0077 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20161228 ANDA ANDA070218 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0078_445b14a5-4414-3d1a-e054-00144ff88e88 70518-0078 HUMAN PRESCRIPTION DRUG Xylocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20161222 NDA NDA006488 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] E 20171231 70518-0079_5c924282-5a10-5f6b-e053-2991aa0a67af 70518-0079 HUMAN PRESCRIPTION DRUG Valproic Acid Valproic Acid CAPSULE, LIQUID FILLED ORAL 20161229 ANDA ANDA073484 REMEDYREPACK INC. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 70518-0080_4a165fa1-41d4-5437-e054-00144ff8d46c 70518-0080 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20161223 ANDA ANDA075576 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0081_445b6d9f-4fb3-420c-e054-00144ff8d46c 70518-0081 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20161223 ANDA ANDA076265 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 70518-0082_5657a947-54dc-66c4-e054-00144ff8d46c 70518-0082 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20161223 ANDA ANDA090478 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70518-0083_445a130f-6155-2534-e054-00144ff88e88 70518-0083 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20161223 ANDA ANDA076958 REMEDYREPACK INC. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 70518-0084_44ad979c-92fb-6ffd-e054-00144ff88e88 70518-0084 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20161227 ANDA ANDA070177 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 70518-0085_44adc67f-2b36-0302-e054-00144ff8d46c 70518-0085 HUMAN PRESCRIPTION DRUG Pyrazinamide Pyrazinamide TABLET ORAL 20161227 ANDA ANDA080157 REMEDYREPACK INC. PYRAZINAMIDE 500 mg/1 Antimycobacterial [EPC] E 20171231 70518-0086_5ccd86c2-a110-49a8-e053-2a91aa0a68fb 70518-0086 HUMAN PRESCRIPTION DRUG UROCIT-K potassium citrate TABLET, EXTENDED RELEASE ORAL 20161228 NDA NDA019071 REMEDYREPACK INC. POTASSIUM CITRATE 10 meq/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 70518-0087_44e80fc5-b8a9-042a-e054-00144ff88e88 70518-0087 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20161228 ANDA ANDA090467 REMEDYREPACK INC. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 70518-0088_47814e58-9044-379b-e054-00144ff88e88 70518-0088 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20161228 ANDA ANDA203458 REMEDYREPACK INC. METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 70518-0089_5ccdbf96-b241-6b04-e053-2a91aa0ac79c 70518-0089 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 20170104 NDA AUTHORIZED GENERIC NDA050784 REMEDYREPACK INC. AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0090_5cce205b-f4c3-818d-e053-2991aa0a260b 70518-0090 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20170104 ANDA ANDA070027 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 70518-0091_4a18877a-3511-4568-e054-00144ff8d46c 70518-0091 HUMAN PRESCRIPTION DRUG Kaletra Lopinavir and Ritonavir TABLET, FILM COATED ORAL 20170105 NDA NDA021906 REMEDYREPACK INC. LOPINAVIR; RITONAVIR 200; 50 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],UDP Glucuronosyltransferases Inducers [MoA],HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA] N 20181231 70518-0092_44d411ab-2c8a-3345-e054-00144ff88e88 70518-0092 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20161229 ANDA ANDA076796 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 70518-0093_4faeb92d-9859-3833-e054-00144ff8d46c 70518-0093 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20161229 ANDA ANDA077824 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70518-0094_4a177fa5-fee7-1711-e054-00144ff8d46c 70518-0094 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20161229 ANDA ANDA077397 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0095_463c87b2-686e-53e2-e054-00144ff88e88 70518-0095 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20161229 ANDA ANDA078251 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70518-0096_4539840b-c173-1118-e054-00144ff8d46c 70518-0096 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20161230 ANDA ANDA080936 REMEDYREPACK INC. ISONIAZID 100 mg/1 Antimycobacterial [EPC] N 20181231 70518-0097_4df08b5d-63d2-5b08-e054-00144ff88e88 70518-0097 HUMAN PRESCRIPTION DRUG Truvada emtricitabine and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20170103 NDA NDA021752 REMEDYREPACK INC. EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 200; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0098_453a3dbc-2c3b-6bb9-e054-00144ff88e88 70518-0098 HUMAN PRESCRIPTION DRUG ibuprofen ibuprofen TABLET ORAL 20170103 ANDA ANDA090796 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0100_502297e7-8e95-3315-e054-00144ff8d46c 70518-0100 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20170109 ANDA ANDA085223 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70518-0101_50dc7e61-01ae-5dee-e054-00144ff8d46c 70518-0101 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20170109 ANDA ANDA076312 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 N 20181231 70518-0102_50dbf0ab-8d48-3ffb-e054-00144ff88e88 70518-0102 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20170109 ANDA ANDA076122 REMEDYREPACK INC. MIRTAZAPINE 30 mg/1 N 20181231 70518-0103_4faef3cb-211d-444c-e054-00144ff8d46c 70518-0103 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20170105 NDA NDA016620 REMEDYREPACK INC. NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 70518-0104_5cce78c2-d222-0c31-e053-2991aa0add43 70518-0104 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20170109 ANDA ANDA075795 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0105_5cde421e-13ef-5419-e053-2a91aa0a0089 70518-0105 HUMAN PRESCRIPTION DRUG Nitrostat nitroglycerin TABLET SUBLINGUAL 20170110 NDA NDA021134 REMEDYREPACK INC. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 70518-0106_45740bf0-f5de-41fa-e054-00144ff8d46c 70518-0106 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride diphenhydramine hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20170106 ANDA ANDA080817 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 70518-0107_5cdfdcb3-ea31-63b9-e053-2a91aa0ae17f 70518-0107 HUMAN PRESCRIPTION DRUG Phenytoin Sodium Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20170113 ANDA ANDA040684 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 70518-0108_45eccb4e-67ff-44ad-e054-00144ff88e88 70518-0108 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20170106 ANDA ANDA065211 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0109_45b3621f-0a08-5e1e-e054-00144ff8d46c 70518-0109 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20170109 ANDA ANDA074185 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70518-0110_5d066ba2-3d05-b3eb-e053-2991aa0aa1b2 70518-0110 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20170117 ANDA ANDA076255 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0111_4a177fa5-fea3-1711-e054-00144ff8d46c 70518-0111 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET ORAL 20170110 ANDA ANDA077795 REMEDYREPACK INC. OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0112_45c432a5-3929-5f04-e054-00144ff88e88 70518-0112 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20170110 ANDA ANDA090528 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 12.5; 50 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0113_5d19aeca-3f52-3b11-e053-2a91aa0a8a11 70518-0113 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20170110 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0114_5d06984f-5ff8-4caf-e053-2a91aa0a2fa7 70518-0114 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170112 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0115_4f1e34e4-0891-5b7c-e054-00144ff8d46c 70518-0115 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20170111 ANDA ANDA074550 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0116_4a6b2384-3d6d-2876-e054-00144ff88e88 70518-0116 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride glipizide and metformin hydrochloride TABLET, FILM COATED ORAL 20170112 ANDA ANDA078083 REMEDYREPACK INC. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0117_471d2f62-0248-08b8-e054-00144ff88e88 70518-0117 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20170112 ANDA ANDA076180 REMEDYREPACK INC. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0118_5877a822-3561-0f4d-e053-2a91aa0aa851 70518-0118 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, COATED ORAL 20170112 ANDA ANDA076003 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 70518-0119_46cc910f-70b3-6b5d-e054-00144ff8d46c 70518-0119 HUMAN OTC DRUG SudoGest Pseudoephedrine Hydrochloride TABLET, FILM COATED ORAL 20170113 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg/1 N 20181231 70518-0120_463caab6-9861-1cfe-e054-00144ff8d46c 70518-0120 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20170113 NDA NDA018487 REMEDYREPACK INC. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70518-0121_5d07274f-e821-6c60-e053-2991aa0a40d8 70518-0121 HUMAN OTC DRUG SudoGest Pseudoephedrine HCl TABLET, FILM COATED ORAL 20170117 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 70518-0122_4ea954d7-e4a7-6e9a-e054-00144ff88e88 70518-0122 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20170113 ANDA ANDA203088 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0123_582703b8-ad9e-a3ae-e053-2a91aa0ad84f 70518-0123 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20170113 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70518-0124_5d0827e2-5d35-9c8e-e053-2a91aa0ac7ec 70518-0124 HUMAN PRESCRIPTION DRUG Carbamazepine carbamazepine CAPSULE, EXTENDED RELEASE ORAL 20170116 NDA AUTHORIZED GENERIC NDA020712 REMEDYREPACK INC. CARBAMAZEPINE 300 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 70518-0125_4a172655-5c28-36f0-e054-00144ff88e88 70518-0125 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20170116 ANDA ANDA077319 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0126_4a1712df-f706-03cd-e054-00144ff8d46c 70518-0126 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20170116 ANDA ANDA077319 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0127_4650c945-8e07-5ad9-e054-00144ff8d46c 70518-0127 HUMAN PRESCRIPTION DRUG Imipramine Hydrochloride Imipramine Hydrochloride TABLET, FILM COATED ORAL 20170116 ANDA ANDA040903 REMEDYREPACK INC. IMIPRAMINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70518-0128_46511630-fc45-67ac-e054-00144ff8d46c 70518-0128 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20170117 ANDA ANDA075693 REMEDYREPACK INC. IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70518-0129_46511630-fccc-67ac-e054-00144ff8d46c 70518-0129 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20170117 ANDA ANDA040715 REMEDYREPACK INC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 70518-0130_517ba7d1-5345-2f3c-e054-00144ff88e88 70518-0130 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20170119 ANDA ANDA070217 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0131_465162dc-4527-4e79-e054-00144ff88e88 70518-0131 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20170117 ANDA ANDA075090 REMEDYREPACK INC. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 70518-0132_465169b9-d536-4d9c-e054-00144ff88e88 70518-0132 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20170117 ANDA ANDA040742 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 70518-0133_5801161c-de31-152b-e053-2991aa0afaf5 70518-0133 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20170117 ANDA ANDA076286 REMEDYREPACK INC. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70518-0134_5de5d8ba-6995-b881-e053-2991aa0aaf46 70518-0134 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20170117 ANDA ANDA076164 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0135_5a46464f-fd9c-c078-e053-2a91aa0a8286 70518-0135 HUMAN OTC DRUG Loratadine antihistamine Loratadine TABLET ORAL 20170117 ANDA ANDA076301 REMEDYREPACK INC. LORATADINE 10 mg/1 N 20181231 70518-0136_4652e805-1c5f-49bd-e054-00144ff8d46c 70518-0136 HUMAN PRESCRIPTION DRUG triamcinolone acetonide triamcinolone acetonide CREAM TOPICAL 20170117 ANDA ANDA085692 REMEDYREPACK INC. TRIAMCINOLONE ACETONIDE 5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0137_4666d1f0-ffb4-5f61-e054-00144ff88e88 70518-0137 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20170118 ANDA ANDA077570 REMEDYREPACK INC. FLUTICASONE PROPIONATE 50 ug/.1g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0138_4666d1f0-ff9f-5f61-e054-00144ff88e88 70518-0138 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20170118 ANDA ANDA064030 REMEDYREPACK INC. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0139_4a414b2e-363f-2138-e054-00144ff8d46c 70518-0139 HUMAN PRESCRIPTION DRUG Lisinopril and hydrochlorothiazide Lisinopril and hydrochlorothiazide TABLET ORAL 20170118 ANDA ANDA076194 REMEDYREPACK INC. LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0140_5d6ac947-3475-7722-e053-2a91aa0a5d62 70518-0140 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20170125 ANDA ANDA077662 REMEDYREPACK INC. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0141_46cbd5ae-efc3-5e2d-e054-00144ff8d46c 70518-0141 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20170123 ANDA ANDA091179 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0142_4666b032-042c-594a-e054-00144ff88e88 70518-0142 HUMAN OTC DRUG Tolnaftate Antifungal Tolnaftate CREAM TOPICAL 20170118 OTC MONOGRAPH FINAL part333C REMEDYREPACK INC. TOLNAFTATE 1 g/100g N 20181231 70518-0143_469041e7-ef03-6c5c-e054-00144ff8d46c 70518-0143 HUMAN PRESCRIPTION DRUG Hydrocortisone Hydrocortisone CREAM TOPICAL 20170119 ANDA ANDA089682 REMEDYREPACK INC. HYDROCORTISONE 25 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0144_5d1a0d37-af98-d56e-e053-2991aa0a97d5 70518-0144 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20170123 ANDA ANDA203044 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0145_5d1a0eee-9d0a-6442-e053-2a91aa0ab9e3 70518-0145 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20170123 ANDA ANDA203044 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0146_62ebcdd4-d4b9-a4b7-e053-2991aa0aaee3 70518-0146 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170120 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 70518-0147_468efe04-1af7-3919-e054-00144ff88e88 70518-0147 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20170119 ANDA ANDA074056 REMEDYREPACK INC. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0148_5d1a4ba1-4018-13d2-e053-2991aa0af7da 70518-0148 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20170123 ANDA ANDA203044 REMEDYREPACK INC. OLANZAPINE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0149_5d1a8aa2-4926-a63b-e053-2991aa0a86c6 70518-0149 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, ORALLY DISINTEGRATING ORAL 20170123 ANDA ANDA203044 REMEDYREPACK INC. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0150_5d1a6795-5037-acfe-e053-2a91aa0a1b06 70518-0150 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET ORAL 20170123 NDA NDA018558 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 70518-0151_5d1ad045-f9e4-26c6-e053-2a91aa0aafd6 70518-0151 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170123 ANDA ANDA091625 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0152_468f631d-19a4-465c-e054-00144ff88e88 70518-0152 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20170119 ANDA ANDA074726 REMEDYREPACK INC. POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 70518-0153_5d1aeef8-4f46-77f2-e053-2a91aa0ad34d 70518-0153 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20170123 ANDA ANDA077670 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0154_469041e7-eeb5-6c5c-e054-00144ff8d46c 70518-0154 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20170119 ANDA ANDA074979 REMEDYREPACK INC. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0155_469041e7-ee9e-6c5c-e054-00144ff8d46c 70518-0155 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20170119 ANDA ANDA077657 REMEDYREPACK INC. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0156_469041e7-ee71-6c5c-e054-00144ff8d46c 70518-0156 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20170119 ANDA ANDA077657 REMEDYREPACK INC. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0157_469041e7-ee88-6c5c-e054-00144ff8d46c 70518-0157 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE ORAL 20170119 ANDA ANDA084769 REMEDYREPACK INC. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0158_5d1b45f6-95a2-5814-e053-2991aa0a34bf 70518-0158 HUMAN PRESCRIPTION DRUG oxybutynin chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20170119 ANDA ANDA207138 REMEDYREPACK INC. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 70518-0159_5d1b45f6-95d7-5814-e053-2991aa0a34bf 70518-0159 HUMAN PRESCRIPTION DRUG RISPERDAL risperidone TABLET ORAL 20170123 NDA NDA020272 REMEDYREPACK INC. RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0160_5d1be431-b68b-1cf6-e053-2a91aa0a4f9b 70518-0160 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20170123 ANDA ANDA072193 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 70518-0161_5d1be431-b6d8-1cf6-e053-2a91aa0a4f9b 70518-0161 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20170123 ANDA ANDA076578 REMEDYREPACK INC. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20181231 70518-0162_5d1c7bd2-5194-8c7f-e053-2991aa0a161b 70518-0162 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20170123 ANDA ANDA071322 REMEDYREPACK INC. DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0163_47a70dc4-c9d7-44dc-e054-00144ff88e88 70518-0163 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20170120 ANDA ANDA075511 REMEDYREPACK INC. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70518-0164_468daf0d-b679-59f1-e054-00144ff8d46c 70518-0164 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20170120 ANDA ANDA070177 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0165_4cec406c-876e-281e-e054-00144ff8d46c 70518-0165 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20170120 ANDA ANDA091179 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0167_5d1e7505-4dca-54dc-e053-2991aa0aab1d 70518-0167 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin calcium TABLET ORAL 20170201 ANDA ANDA079167 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0168_468e7df1-fa46-5f64-e054-00144ff8d46c 70518-0168 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170120 ANDA ANDA065169 REMEDYREPACK INC. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 70518-0169_4f1dfa5f-f3c8-4ae2-e054-00144ff8d46c 70518-0169 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20170123 ANDA ANDA078332 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70518-0170_4a178bd5-d5dd-0e2f-e054-00144ff8d46c 70518-0170 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20170123 ANDA ANDA075049 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0171_4a172655-5b78-36f0-e054-00144ff88e88 70518-0171 HUMAN PRESCRIPTION DRUG MELOXICAM meloxicam TABLET ORAL 20170123 ANDA ANDA077929 REMEDYREPACK INC. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0172_5b37ad88-ff87-4d29-e053-2991aa0aed65 70518-0172 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20170123 ANDA ANDA202717 REMEDYREPACK INC. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 70518-0173_47a6ea98-2317-3c0e-e054-00144ff88e88 70518-0173 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170123 ANDA ANDA065169 REMEDYREPACK INC. CEFTRIAXONE SODIUM 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 70518-0174_4f1dccbe-f730-0563-e054-00144ff88e88 70518-0174 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20170123 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 25; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0175_47074717-c758-5065-e054-00144ff88e88 70518-0175 HUMAN PRESCRIPTION DRUG Mometasone Furoate mometasone furoate OINTMENT TOPICAL 20170125 ANDA ANDA077061 REMEDYREPACK INC. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0176_4cef513d-0383-6fa8-e054-00144ff88e88 70518-0176 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170125 ANDA ANDA091625 REMEDYREPACK INC. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0177_4707ae1e-81d9-6153-e054-00144ff88e88 70518-0177 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20170125 ANDA ANDA080704 REMEDYREPACK INC. ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 70518-0178_4d261927-2fb3-4074-e054-00144ff88e88 70518-0178 HUMAN PRESCRIPTION DRUG Naproxen sodium Naproxen sodium TABLET, FILM COATED ORAL 20170125 ANDA ANDA078486 REMEDYREPACK INC. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0179_47812326-6a15-1d36-e054-00144ff8d46c 70518-0179 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20170126 ANDA ANDA202433 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70518-0180_4706fe96-cd0c-6a85-e054-00144ff8d46c 70518-0180 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20170126 ANDA ANDA076921 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 N 20181231 70518-0181_471c713f-d98a-66b9-e054-00144ff88e88 70518-0181 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET, EXTENDED RELEASE ORAL 20170127 ANDA ANDA078115 REMEDYREPACK INC. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 70518-0182_518fa7ba-779e-5b22-e054-00144ff88e88 70518-0182 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20170127 ANDA ANDA077829 REMEDYREPACK INC. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 70518-0184_471c8f96-4be0-6e8e-e054-00144ff8d46c 70518-0184 HUMAN PRESCRIPTION DRUG Doxazosin Mesylate Doxazosin Mesylate TABLET ORAL 20170127 ANDA ANDA076161 REMEDYREPACK INC. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70518-0185_476a6775-7994-1076-e054-00144ff88e88 70518-0185 HUMAN PRESCRIPTION DRUG Sulfasalazine Sulfasalazine TABLET ORAL 20170130 ANDA ANDA085828 REMEDYREPACK INC. SULFASALAZINE 500 mg/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 70518-0186_48115229-73f2-024b-e054-00144ff8d46c 70518-0186 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170131 ANDA ANDA090548 REMEDYREPACK INC. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0187_4cec147c-cee6-10b5-e054-00144ff88e88 70518-0187 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20170131 ANDA ANDA065055 REMEDYREPACK INC. DOXYCYCLINE 100 mg/1 N 20181231 70518-0188_58730b28-a91a-5e0d-e053-2991aa0a6541 70518-0188 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20170905 ANDA ANDA076900 REMEDYREPACK INC. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0189_47a6ea98-23a3-3c0e-e054-00144ff88e88 70518-0189 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20170131 ANDA ANDA090467 REMEDYREPACK INC. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0190_5d5d299e-8873-fc76-e053-2991aa0ad5b4 70518-0190 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20170320 ANDA ANDA075798 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 70518-0191_5876cd01-6746-6e4e-e053-2a91aa0abb55 70518-0191 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20170202 ANDA ANDA078048 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70518-0192_479376b5-91c5-01f9-e054-00144ff8d46c 70518-0192 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20170202 ANDA ANDA076407 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 70518-0193_47a6ea98-22e2-3c0e-e054-00144ff88e88 70518-0193 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20170202 ANDA ANDA065211 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0194_5ac31997-62e4-467b-e053-2a91aa0af3c3 70518-0194 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20170202 ANDA ANDA075991 REMEDYREPACK INC. LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0195_50229268-694d-4e90-e054-00144ff8d46c 70518-0195 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET ORAL 20170203 ANDA ANDA090844 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 70518-0196_4df09bdf-e2d6-25ce-e054-00144ff8d46c 70518-0196 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20170203 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0197_5d5d617d-8a3f-b932-e053-2a91aa0a12a4 70518-0197 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20170208 ANDA ANDA090843 REMEDYREPACK INC. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0198_5d5d7fd3-b3f4-2fd1-e053-2991aa0a15c3 70518-0198 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20170208 ANDA ANDA091226 REMEDYREPACK INC. ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0199_47e610f5-ab80-3c7d-e054-00144ff8d46c 70518-0199 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20170206 ANDA ANDA091672 REMEDYREPACK INC. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0200_5b37a119-397a-f749-e053-2a91aa0aba9a 70518-0200 HUMAN PRESCRIPTION DRUG MELOXICAM meloxicam TABLET ORAL 20170206 ANDA ANDA077929 REMEDYREPACK INC. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0201_5d6ab3d1-0bd4-5cc9-e053-2a91aa0a716f 70518-0201 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20170207 ANDA ANDA077670 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0202_4da0bac8-49e2-6491-e054-00144ff88e88 70518-0202 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20170206 ANDA ANDA074625 REMEDYREPACK INC. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 70518-0203_480ee4ba-a8a6-07ee-e054-00144ff8d46c 70518-0203 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20170207 ANDA ANDA076008 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 70518-0204_5ae7768c-af44-2e2c-e053-2a91aa0a0572 70518-0204 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20170207 ANDA ANDA065489 REMEDYREPACK INC. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70518-0205_480e73ed-b7a1-6ada-e054-00144ff88e88 70518-0205 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20170208 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 N 20181231 70518-0206_5d6b273d-7708-635f-e053-2991aa0acd8d 70518-0206 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20170213 ANDA ANDA075828 REMEDYREPACK INC. LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0207_480e73ed-b786-6ada-e054-00144ff88e88 70518-0207 HUMAN OTC DRUG Major Clotrimazole CLOTRIMAZOLE CREAM TOPICAL 20170208 OTC MONOGRAPH FINAL part333C REMEDYREPACK INC. CLOTRIMAZOLE 10 mg/g N 20181231 70518-0208_481fddb0-cf6f-6073-e054-00144ff88e88 70518-0208 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20170209 ANDA ANDA078250 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0209_4d6421c5-0aaa-5419-e054-00144ff8d46c 70518-0209 HUMAN PRESCRIPTION DRUG hydroxyzine pamoate hydroxyzine pamoate CAPSULE ORAL 20170209 ANDA ANDA087479 REMEDYREPACK INC. HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 70518-0210_4faccb64-e2b2-5617-e054-00144ff8d46c 70518-0210 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20170209 ANDA ANDA202556 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0211_4a6b0ef3-6ece-2fc3-e054-00144ff88e88 70518-0211 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET ORAL 20170209 ANDA ANDA090478 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70518-0212_5d6b4575-90bb-1d63-e053-2a91aa0a9a6e 70518-0212 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170214 ANDA ANDA088628 REMEDYREPACK INC. ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20181231 70518-0213_62101b84-df0e-7996-e053-2a91aa0a6376 70518-0213 HUMAN PRESCRIPTION DRUG DOXYCYCLINE DOXYCYCLINE CAPSULE ORAL 20170210 ANDA ANDA204234 REMEDYREPACK INC. DOXYCYCLINE 100 mg/1 N 20191231 70518-0214_48846dec-56e6-52b1-e054-00144ff8d46c 70518-0214 HUMAN PRESCRIPTION DRUG ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET ORAL 20170210 ANDA ANDA075395 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 70518-0215_5d6b6792-dd84-3051-e053-2a91aa0ab25c 70518-0215 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20170214 ANDA ANDA077156 REMEDYREPACK INC. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 70518-0216_615a2a8d-7bc8-4882-e053-2a91aa0a735f 70518-0216 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET ORAL 20170216 ANDA ANDA076820 REMEDYREPACK INC. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70518-0217_5d6bdc17-5c3c-7dec-e053-2991aa0aa450 70518-0217 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20170215 ANDA ANDA091672 REMEDYREPACK INC. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0218_4c99f8f4-f72c-3b33-e054-00144ff88e88 70518-0218 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20170214 UNAPPROVED DRUG OTHER REMEDYREPACK INC. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 70518-0219_4884c245-3e14-61a4-e054-00144ff8d46c 70518-0219 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION/ DROPS OPHTHALMIC 20170214 ANDA ANDA064096 REMEDYREPACK INC. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 70518-0220_5d6c668a-8079-de18-e053-2991aa0a38fb 70518-0220 HUMAN PRESCRIPTION DRUG K-Tab Potassium Chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170215 NDA NDA018279 REMEDYREPACK INC. POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 70518-0221_5d6c668a-809c-de18-e053-2991aa0a38fb 70518-0221 HUMAN PRESCRIPTION DRUG Doxycycline doxycycline CAPSULE ORAL 20170215 ANDA ANDA065055 REMEDYREPACK INC. DOXYCYCLINE 100 mg/1 N 20181231 70518-0222_49b19c1b-927b-25ec-e054-00144ff8d46c 70518-0222 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20170215 ANDA ANDA077824 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70518-0223_49525f5d-9fd8-0c61-e054-00144ff8d46c 70518-0223 HUMAN PRESCRIPTION DRUG METHOTREXATE METHOTREXATE TABLET ORAL 20170215 NDA NDA008085 REMEDYREPACK INC. METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 70518-0224_4929c254-adf8-5be7-e054-00144ff8d46c 70518-0224 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170215 ANDA ANDA090548 REMEDYREPACK INC. ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0225_4f1ceb2a-dfba-1cdf-e054-00144ff8d46c 70518-0225 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20170216 ANDA ANDA065193 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0226_5e84b3f5-b35d-2d73-e053-2a91aa0accfb 70518-0226 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20170215 ANDA ANDA090074 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 70518-0227_5d6ca99c-48b9-6288-e053-2a91aa0ae884 70518-0227 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170220 ANDA ANDA077285 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 70518-0228_49b22812-771f-435a-e054-00144ff88e88 70518-0228 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170216 NDA NDA021282 REMEDYREPACK INC. GUAIFENESIN 600 mg/1 N 20181231 70518-0229_4cef94c8-d725-065c-e054-00144ff88e88 70518-0229 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20170216 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0230_5d6ecdbc-ecf5-fd2c-e053-2991aa0a3832 70518-0230 HUMAN PRESCRIPTION DRUG DESCOVY emtricitabine and tenofovir alafenamide fumarate TABLET ORAL 20170220 NDA NDA208215 REMEDYREPACK INC. EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 200; 25 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0231_63f13d96-3bed-437f-e053-2a91aa0aafcc 70518-0231 HUMAN PRESCRIPTION DRUG Extended Phenytoin Sodium Phenytoin Sodium CAPSULE ORAL 20170220 ANDA ANDA040765 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20191231 70518-0232_49265b22-0f95-35d9-e054-00144ff8d46c 70518-0232 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20170216 NDA NDA019962 REMEDYREPACK INC. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0233_5d6f5b3e-60f8-105b-e053-2a91aa0af7c0 70518-0233 HUMAN PRESCRIPTION DRUG topiramate topiramate TABLET, FILM COATED ORAL 20170220 ANDA ANDA078235 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0234_4925fbf0-5b0b-230d-e054-00144ff88e88 70518-0234 HUMAN PRESCRIPTION DRUG TOPROL XL Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20170216 NDA NDA019962 REMEDYREPACK INC. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0235_4a18ab9e-3c2f-589e-e054-00144ff8d46c 70518-0235 HUMAN PRESCRIPTION DRUG ondansetron ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20170217 ANDA ANDA077557 REMEDYREPACK INC. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 70518-0236_4b350a20-7e0b-6599-e054-00144ff88e88 70518-0236 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 20170217 ANDA ANDA040317 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70518-0237_49253411-2066-6ebf-e054-00144ff8d46c 70518-0237 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20170217 ANDA ANDA075967 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0238_4da0bac8-49b8-6491-e054-00144ff88e88 70518-0238 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20170220 ANDA ANDA063029 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 70518-0239_4a6b0ef3-6e80-2fc3-e054-00144ff88e88 70518-0239 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20170220 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0240_4c9c3c5a-22f3-4b90-e054-00144ff8d46c 70518-0240 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20170220 ANDA ANDA077670 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0241_49250416-5f55-65ef-e054-00144ff8d46c 70518-0241 HUMAN PRESCRIPTION DRUG Prazosin Hydrochloride prazosin hydrochloride CAPSULE ORAL 20170220 ANDA ANDA072575 REMEDYREPACK INC. PRAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70518-0242_62d80793-ad6b-70c3-e053-2a91aa0acc85 70518-0242 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20170220 ANDA ANDA040362 REMEDYREPACK INC. PREDNISONE 20 mg/1 N 20191231 70518-0243_5d6fbe4d-9f28-97ac-e053-2a91aa0aaa0e 70518-0243 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20170221 ANDA ANDA088299 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 70518-0244_4af2f9ce-71be-2ec3-e054-00144ff8d46c 70518-0244 HUMAN PRESCRIPTION DRUG PROAIR HFA Albuterol Sulfate AEROSOL, METERED RESPIRATORY (INHALATION) 20170221 NDA NDA021457 REMEDYREPACK INC. ALBUTEROL SULFATE 90 ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 70518-0245_49256e44-4de7-133f-e054-00144ff88e88 70518-0245 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20170221 ANDA ANDA090083 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0246_4faefb1a-96bd-441d-e054-00144ff8d46c 70518-0246 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170221 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0247_5d718239-59bf-a3fa-e053-2a91aa0a190b 70518-0247 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20170227 ANDA ANDA065062 REMEDYREPACK INC. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 70518-0248_4d121cec-a922-25ea-e054-00144ff88e88 70518-0248 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20170222 ANDA ANDA200981 REMEDYREPACK INC. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0249_5d718239-59d9-a3fa-e053-2a91aa0a190b 70518-0249 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate TABLET, FILM COATED ORAL 20170222 NDA NDA050711 REMEDYREPACK INC. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0250_517ba7d1-5313-2f3c-e054-00144ff88e88 70518-0250 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20170223 ANDA ANDA040622 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0251_4faeb92d-986c-3833-e054-00144ff8d46c 70518-0251 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20170222 ANDA ANDA077293 REMEDYREPACK INC. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70518-0252_4928009d-5ef0-5950-e054-00144ff88e88 70518-0252 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20170222 ANDA ANDA076118 REMEDYREPACK INC. BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70518-0253_4db3118b-7c78-61e1-e054-00144ff8d46c 70518-0253 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20170223 ANDA ANDA040616 REMEDYREPACK INC. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70518-0254_493d29e2-4c0f-4451-e054-00144ff8d46c 70518-0254 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20170223 ANDA ANDA091276 REMEDYREPACK INC. INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0255_5d71eb7c-6a35-0583-e053-2a91aa0a73ac 70518-0255 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20170228 ANDA ANDA040616 REMEDYREPACK INC. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70518-0256_4cef513d-03ac-6fa8-e054-00144ff88e88 70518-0256 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20170223 ANDA ANDA065062 REMEDYREPACK INC. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 70518-0257_5d80e6a5-d99b-c5b2-e053-2a91aa0a3343 70518-0257 HUMAN PRESCRIPTION DRUG Vimpat lacosamide TABLET, FILM COATED ORAL 20170301 NDA NDA022253 REMEDYREPACK INC. LACOSAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] CV N 20181231 70518-0258_5d80d8b1-f11e-b3e0-e053-2a91aa0aeee7 70518-0258 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20170228 ANDA ANDA075964 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 70518-0259_493bbdfa-7d53-64fc-e054-00144ff88e88 70518-0259 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20170223 ANDA ANDA074979 REMEDYREPACK INC. CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0260_5d82734f-b367-c09e-e053-2a91aa0a6c38 70518-0260 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20170228 ANDA ANDA040616 REMEDYREPACK INC. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70518-0261_5d851387-8737-6117-e053-2a91aa0a5deb 70518-0261 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20170301 ANDA ANDA040616 REMEDYREPACK INC. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70518-0262_5d855582-f0a9-0864-e053-2a91aa0a0a36 70518-0262 HUMAN PRESCRIPTION DRUG FLUOXETINE FLUOXETINE CAPSULE ORAL 20170228 ANDA ANDA204597 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0263_4b8463e4-6f51-1732-e054-00144ff8d46c 70518-0263 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20170227 ANDA ANDA077824 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70518-0264_49b1b006-b842-354e-e054-00144ff88e88 70518-0264 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20170227 ANDA ANDA076008 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 70518-0265_4d260edc-255f-0e3b-e054-00144ff8d46c 70518-0265 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20170228 NDA NDA020064 REMEDYREPACK INC. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 70518-0266_5d851387-8782-6117-e053-2a91aa0a5deb 70518-0266 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20170302 ANDA ANDA040616 REMEDYREPACK INC. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70518-0267_59b8c6cb-6459-92a5-e053-2a91aa0a56a1 70518-0267 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170301 ANDA ANDA075350 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0268_5d8644d6-2f96-2f72-e053-2a91aa0a6422 70518-0268 HUMAN PRESCRIPTION DRUG Guanfacine guanfacine Hydrochloride TABLET ORAL 20170517 ANDA ANDA074796 REMEDYREPACK INC. GUANFACINE HYDROCHLORIDE 1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70518-0269_4eb81165-b9c7-736d-e054-00144ff8d46c 70518-0269 HUMAN PRESCRIPTION DRUG alendronate sodium alendronate sodium TABLET ORAL 20170303 ANDA ANDA076984 REMEDYREPACK INC. ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 70518-0270_6210d572-6204-4445-e053-2991aa0a360d 70518-0270 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20170303 ANDA ANDA077839 REMEDYREPACK INC. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 70518-0271_49c5d027-d223-4616-e054-00144ff8d46c 70518-0271 HUMAN PRESCRIPTION DRUG Polymyxin B Sulfate and Trimethoprim Polymyxin B Sulfate and Trimethoprim Sulfate SOLUTION/ DROPS OPHTHALMIC 20170302 ANDA ANDA064120 REMEDYREPACK INC. POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10000; 1 [USP'U]/mL; mg/mL Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 70518-0272_4f5eaaa3-4b1c-6caa-e054-00144ff8d46c 70518-0272 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION OPHTHALMIC 20170302 ANDA ANDA078559 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 70518-0273_4af87197-0709-1c73-e054-00144ff88e88 70518-0273 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20170302 ANDA ANDA040616 REMEDYREPACK INC. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70518-0274_4b350a20-7e40-6599-e054-00144ff88e88 70518-0274 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20170302 ANDA ANDA077073 REMEDYREPACK INC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70518-0275_49c61dec-bd98-5301-e054-00144ff8d46c 70518-0275 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20170302 ANDA ANDA078203 REMEDYREPACK INC. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0276_49c623c6-d963-10e9-e054-00144ff88e88 70518-0276 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20170302 ANDA ANDA077666 REMEDYREPACK INC. MIRTAZAPINE 30 mg/1 N 20181231 70518-0277_518fa7ba-778d-5b22-e054-00144ff88e88 70518-0277 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20170302 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70518-0278_4a6b0ef3-6ef9-2fc3-e054-00144ff88e88 70518-0278 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20170302 ANDA ANDA077662 REMEDYREPACK INC. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0279_5d984e1a-8589-711f-e053-2991aa0a25bf 70518-0279 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20170308 ANDA ANDA040616 REMEDYREPACK INC. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70518-0280_5d9978f7-d61e-42da-e053-2a91aa0ac19a 70518-0280 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20170309 ANDA ANDA040616 REMEDYREPACK INC. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70518-0281_49d9e42a-313e-4afa-e054-00144ff88e88 70518-0281 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20170303 ANDA ANDA205087 REMEDYREPACK INC. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 70518-0282_49d9dad2-571d-56b3-e054-00144ff8d46c 70518-0282 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20170303 ANDA ANDA079163 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 70518-0283_4a177fa5-ffb6-1711-e054-00144ff8d46c 70518-0283 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20170306 ANDA ANDA072205 REMEDYREPACK INC. LOXAPINE SUCCINATE 10 mg/1 N 20181231 70518-0284_49da9c6a-fd9d-09cd-e054-00144ff8d46c 70518-0284 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170303 ANDA ANDA074802 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 70518-0285_642e91b2-a46d-ed83-e053-2991aa0ab975 70518-0285 HUMAN OTC DRUG Banophen Diphenhydramine HCl TABLET ORAL 20170306 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 70518-0286_4a172655-5b3c-36f0-e054-00144ff88e88 70518-0286 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20170306 ANDA ANDA090074 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 70518-0287_4a1802b9-3e77-33f0-e054-00144ff8d46c 70518-0287 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20170306 ANDA ANDA070176 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0288_5dab3a7c-f06d-6191-e053-2a91aa0a2756 70518-0288 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170307 ANDA ANDA076467 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0289_5dab3a7c-f097-6191-e053-2a91aa0a2756 70518-0289 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20170314 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0290_50378981-7958-481e-e054-00144ff88e88 70518-0290 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 20170309 ANDA ANDA062396 REMEDYREPACK INC. DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 70518-0291_4af9857d-9dae-4299-e054-00144ff88e88 70518-0291 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20170308 ANDA ANDA078050 REMEDYREPACK INC. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 70518-0292_5dad3643-417e-7da3-e053-2991aa0a4c53 70518-0292 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20170317 ANDA ANDA090480 REMEDYREPACK INC. MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 70518-0293_54b6dd62-3a60-3b3c-e054-00144ff88e88 70518-0293 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170308 ANDA ANDA090858 REMEDYREPACK INC. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0294_5dad7704-65cb-7348-e053-2a91aa0aa6ea 70518-0294 HUMAN PRESCRIPTION DRUG MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET, COATED ORAL 20170308 ANDA ANDA203432 REMEDYREPACK INC. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 70518-0296_4ea93c7c-2661-2a35-e054-00144ff8d46c 70518-0296 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20170308 ANDA ANDA078181 REMEDYREPACK INC. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0297_4df08b5d-6398-5b08-e054-00144ff88e88 70518-0297 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20170308 ANDA ANDA077073 REMEDYREPACK INC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70518-0298_5de6d210-7be2-a255-e053-2991aa0a322f 70518-0298 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20170321 NDA AUTHORIZED GENERIC NDA020405 REMEDYREPACK INC. DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 70518-0299_5de7ce44-b933-8e4c-e053-2991aa0a02ba 70518-0299 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20170309 ANDA ANDA040616 REMEDYREPACK INC. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70518-0300_4a52c0c2-85ef-2819-e054-00144ff8d46c 70518-0300 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20170309 ANDA ANDA200981 REMEDYREPACK INC. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0301_4d123293-4822-3391-e054-00144ff8d46c 70518-0301 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20170309 ANDA ANDA071611 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70518-0302_4a6ada6e-9711-1435-e054-00144ff8d46c 70518-0302 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20170309 ANDA ANDA085082 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70518-0303_5de7ce44-b974-8e4c-e053-2991aa0a02ba 70518-0303 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 20170315 NDA NDA018140 REMEDYREPACK INC. LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0304_4a69971a-a7f4-4b13-e054-00144ff8d46c 70518-0304 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20170310 ANDA ANDA077987 REMEDYREPACK INC. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0305_5de7d14b-36e4-f5e3-e053-2a91aa0ae9b1 70518-0305 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20170313 ANDA ANDA040256 REMEDYREPACK INC. PREDNISONE 5 mg/1 N 20181231 70518-0306_4faeb3a0-0712-476e-e054-00144ff88e88 70518-0306 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20170310 ANDA ANDA084283 REMEDYREPACK INC. PREDNISONE 50 mg/1 N 20181231 70518-0307_5de7d14b-3728-f5e3-e053-2a91aa0ae9b1 70518-0307 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20170313 ANDA ANDA040256 REMEDYREPACK INC. PREDNISONE 10 mg/1 N 20181231 70518-0308_4a6ada6e-9744-1435-e054-00144ff8d46c 70518-0308 HUMAN PRESCRIPTION DRUG Ofloxacin Ofloxacin SOLUTION/ DROPS OPHTHALMIC 20170310 ANDA ANDA076407 REMEDYREPACK INC. OFLOXACIN 3 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 70518-0309_4a6b2384-3d3b-2876-e054-00144ff88e88 70518-0309 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20170310 ANDA ANDA070175 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0310_5de8bc86-4a21-47ec-e053-2a91aa0a475a 70518-0310 HUMAN PRESCRIPTION DRUG FLOVENT HFA fluticasone propionate AEROSOL, METERED RESPIRATORY (INHALATION) 20170314 NDA NDA021433 REMEDYREPACK INC. FLUTICASONE PROPIONATE 220 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0312_5de9e74d-ea75-a9b9-e053-2991aa0a23b8 70518-0312 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20170322 ANDA ANDA090161 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 70518-0313_59b85435-d5ef-7092-e053-2a91aa0a4a07 70518-0313 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20170313 ANDA ANDA072741 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 70518-0314_5e212948-67d2-bdf2-e053-2991aa0a649f 70518-0314 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20170317 ANDA ANDA090798 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0315_5e212948-6843-bdf2-e053-2991aa0a649f 70518-0315 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20170317 ANDA ANDA075677 REMEDYREPACK INC. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 70518-0316_4adff0d5-c39f-5908-e054-00144ff8d46c 70518-0316 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20170314 ANDA ANDA076921 REMEDYREPACK INC. MIRTAZAPINE 30 mg/1 N 20181231 70518-0317_4adff0d5-c409-5908-e054-00144ff8d46c 70518-0317 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20170315 ANDA ANDA075317 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70518-0318_5e1fc297-6437-b975-e053-2a91aa0ad548 70518-0318 HUMAN PRESCRIPTION DRUG Fluphenazine Hydrochloride Fluphenazine Hydrochloride TABLET, FILM COATED ORAL 20170327 ANDA ANDA089743 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0319_5e218764-e6c0-85b3-e053-2a91aa0a871c 70518-0319 HUMAN PRESCRIPTION DRUG Tobramycin Tobramycin SOLUTION OPHTHALMIC 20170317 ANDA ANDA064052 REMEDYREPACK INC. TOBRAMYCIN 3 mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 70518-0320_4ae01398-b1a5-2918-e054-00144ff88e88 70518-0320 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20170315 ANDA ANDA203854 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0321_4adfa75f-d0c0-48d1-e054-00144ff8d46c 70518-0321 HUMAN OTC DRUG Leader migraine formula Acetaminophen, Aspirin, Caffeine TABLET ORAL 20170316 ANDA ANDA075794 REMEDYREPACK INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 70518-0323_4adfa72a-ab0e-34db-e054-00144ff88e88 70518-0323 HUMAN PRESCRIPTION DRUG Valacyclovir Valacyclovir TABLET, FILM COATED ORAL 20170316 ANDA ANDA076588 REMEDYREPACK INC. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 70518-0324_4adff0d5-c4d4-5908-e054-00144ff8d46c 70518-0324 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20170316 ANDA ANDA070027 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 70518-0325_5919c913-09d4-a4d4-e053-2991aa0a7789 70518-0325 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20170316 ANDA ANDA075209 REMEDYREPACK INC. LORATADINE 10 mg/1 N 20181231 70518-0326_4ae09dd0-a7de-022d-e054-00144ff8d46c 70518-0326 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20170316 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. DOCUSATE SODIUM 100 mg/1 N 20181231 70518-0327_5b6659fd-2d34-5a80-e053-2a91aa0a9ac7 70518-0327 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 20170317 ANDA ANDA084285 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70518-0328_4f0e8ccc-9f9e-1a2e-e054-00144ff8d46c 70518-0328 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20170320 ANDA ANDA203245 REMEDYREPACK INC. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70518-0329_5e21a45c-1635-4541-e053-2991aa0ade40 70518-0329 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170320 ANDA ANDA203145 REMEDYREPACK INC. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0331_5e218569-54df-fe64-e053-2991aa0a36c5 70518-0331 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20170320 ANDA ANDA202717 REMEDYREPACK INC. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 70518-0332_4cef513d-032e-6fa8-e054-00144ff88e88 70518-0332 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170317 ANDA ANDA075350 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0333_5e230175-54d2-2f30-e053-2a91aa0af832 70518-0333 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20170330 ANDA ANDA076343 REMEDYREPACK INC. TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0334_4be6e524-70ac-6eb8-e054-00144ff88e88 70518-0334 HUMAN PRESCRIPTION DRUG SOLU-MEDROL methylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170317 NDA NDA011856 REMEDYREPACK INC. METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0335_50c3a7ee-0546-363b-e054-00144ff88e88 70518-0335 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20170317 ANDA ANDA090510 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0336_5e223963-2b20-524c-e053-2a91aa0aff84 70518-0336 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate TABLET, FILM COATED ORAL 20170320 NDA NDA050784 REMEDYREPACK INC. AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0337_5e23382d-7883-14e8-e053-2a91aa0a4e3b 70518-0337 HUMAN PRESCRIPTION DRUG Tegretol XR carbamazepine TABLET, EXTENDED RELEASE ORAL 20170330 NDA NDA020234 REMEDYREPACK INC. CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 70518-0338_5e2556bd-08d2-602b-e053-2a91aa0a8db1 70518-0338 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20170329 NDA AUTHORIZED GENERIC NDA020405 REMEDYREPACK INC. DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 70518-0339_4b350a20-7d85-6599-e054-00144ff88e88 70518-0339 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20170320 ANDA ANDA075502 REMEDYREPACK INC. CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0340_4b35514f-e9c0-26b3-e054-00144ff8d46c 70518-0340 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20170320 ANDA ANDA077689 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 70518-0341_6181e6d5-fca7-ce10-e053-2a91aa0a09e2 70518-0341 HUMAN PRESCRIPTION DRUG Atripla efavirenz, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20170329 NDA NDA021937 REMEDYREPACK INC. EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 600; 200; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0342_4b35514f-e8ea-26b3-e054-00144ff8d46c 70518-0342 HUMAN PRESCRIPTION DRUG Terazosin Terazosin Hydrochloride CAPSULE ORAL 20170320 ANDA ANDA075317 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70518-0343_4c9a9225-473f-6b06-e054-00144ff8d46c 70518-0343 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20170320 ANDA ANDA203088 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0344_5e26c6c8-45dd-5a60-e053-2a91aa0a766e 70518-0344 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20170330 ANDA ANDA076343 REMEDYREPACK INC. TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0345_5e3686bf-be0b-828d-e053-2a91aa0a6a90 70518-0345 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20170322 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0346_4b6c71e1-e20c-62e7-e054-00144ff8d46c 70518-0346 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20170321 ANDA ANDA072204 REMEDYREPACK INC. LOXAPINE SUCCINATE 5 mg/1 N 20181231 70518-0347_4b6bae78-ab5d-1b8a-e054-00144ff88e88 70518-0347 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20170321 ANDA ANDA072206 REMEDYREPACK INC. LOXAPINE SUCCINATE 25 mg/1 N 20181231 70518-0348_4b499502-f1c9-2d5f-e054-00144ff8d46c 70518-0348 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20170321 ANDA ANDA076368 REMEDYREPACK INC. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 70518-0349_4c9cc9ab-43be-69fd-e054-00144ff8d46c 70518-0349 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170322 ANDA ANDA077415 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 70518-0350_5645316b-cdbf-3d05-e054-00144ff8d46c 70518-0350 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20170322 ANDA ANDA078895 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70518-0351_4c9ab038-4621-717f-e054-00144ff88e88 70518-0351 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20170322 ANDA ANDA073025 REMEDYREPACK INC. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0353_592c66cc-5ccf-b1b5-e053-2991aa0a335a 70518-0353 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20170323 ANDA ANDA065153 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0354_4b6ce7f1-4a43-0c24-e054-00144ff8d46c 70518-0354 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET ORAL 20170323 ANDA ANDA090528 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM 25; 100 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0355_5205decb-5ad4-6d13-e054-00144ff88e88 70518-0355 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20170323 ANDA ANDA090564 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0356_5bc41b5e-d9a9-9f86-e053-2a91aa0aaadf 70518-0356 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20170323 ANDA ANDA077614 REMEDYREPACK INC. CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70518-0357_517d4a13-6c25-64e5-e054-00144ff88e88 70518-0357 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride trihexyphenidyl hydrochloride TABLET ORAL 20170324 ANDA ANDA040254 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 5 mg/1 N 20181231 70518-0358_5c7d6e1d-d87b-533d-e053-2a91aa0a3cca 70518-0358 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20170323 ANDA ANDA074305 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0359_50d89500-8b85-518f-e054-00144ff88e88 70518-0359 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride TABLET, FILM COATED ORAL 20170424 ANDA ANDA065436 REMEDYREPACK INC. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 70518-0360_4b84b8e9-18e5-2355-e054-00144ff8d46c 70518-0360 HUMAN PRESCRIPTION DRUG Lithium Carbonate lithium carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170324 ANDA ANDA202288 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 70518-0361_4b8463e4-6f2e-1732-e054-00144ff8d46c 70518-0361 HUMAN OTC DRUG Rugby Travel Sickness Meclizine HCl, 25 mg Each (Antiemetic) Meclizine HCl TABLET, CHEWABLE ORAL 20170324 OTC MONOGRAPH FINAL part336 REMEDYREPACK INC. MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 70518-0362_4fe64728-34f1-11ec-e054-00144ff88e88 70518-0362 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20170324 ANDA ANDA078220 REMEDYREPACK INC. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 70518-0363_4b8463e4-6ec1-1732-e054-00144ff8d46c 70518-0363 HUMAN PRESCRIPTION DRUG Duloxetine hydrochloride Duloxetin hydrochloride CAPSULE, DELAYED RELEASE ORAL 20170324 ANDA ANDA090774 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0364_5e384457-352c-3702-e053-2991aa0a7072 70518-0364 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20170405 ANDA ANDA201003 REMEDYREPACK INC. RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0365_4be6e524-6fe1-6eb8-e054-00144ff88e88 70518-0365 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20170327 ANDA ANDA078106 REMEDYREPACK INC. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0366_4be6e524-6fce-6eb8-e054-00144ff88e88 70518-0366 HUMAN PRESCRIPTION DRUG Silver Sulfadiazine Silver Sulfadiazine CREAM TOPICAL 20170328 NDA NDA018810 REMEDYREPACK INC. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 70518-0367_4c99de71-8491-4de0-e054-00144ff8d46c 70518-0367 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20170328 ANDA ANDA077073 REMEDYREPACK INC. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70518-0368_5f11e01d-c062-1c24-e053-2991aa0af5cd 70518-0368 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20170329 ANDA ANDA076639 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 70518-0369_5e386a38-5394-3b0f-e053-2991aa0a85ee 70518-0369 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20170404 ANDA ANDA078619 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0370_5e386a38-53f5-3b0f-e053-2991aa0a85ee 70518-0370 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20170407 ANDA ANDA076343 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0371_4d03bb2c-972f-533d-e054-00144ff8d46c 70518-0371 HUMAN OTC DRUG Loratadine and Pseudoephedrine Sulfate Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170329 ANDA ANDA076557 REMEDYREPACK INC. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 70518-0372_50dbf0ab-8d2d-3ffb-e054-00144ff88e88 70518-0372 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20170403 ANDA ANDA090564 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0373_4cebed0e-526f-1b09-e054-00144ff8d46c 70518-0373 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20170403 ANDA ANDA077270 REMEDYREPACK INC. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0374_5e39fe28-d205-644b-e053-2a91aa0a8e1d 70518-0374 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20170519 ANDA ANDA078597 REMEDYREPACK INC. DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 70518-0375_5140b785-6ac2-1c80-e054-00144ff8d46c 70518-0375 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20170403 ANDA ANDA206434 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0376_4c99497d-16b8-4641-e054-00144ff88e88 70518-0376 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20170403 ANDA ANDA203245 REMEDYREPACK INC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70518-0377_4c89fc8a-f25c-3632-e054-00144ff8d46c 70518-0377 HUMAN PRESCRIPTION DRUG Lithium Carbonate lithium carbonate TABLET, EXTENDED RELEASE ORAL 20170331 ANDA ANDA202219 REMEDYREPACK INC. LITHIUM CARBONATE 450 mg/1 Mood Stabilizer [EPC] N 20181231 70518-0378_4c9cc359-793e-4fb2-e054-00144ff8d46c 70518-0378 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20170331 ANDA ANDA077670 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0379_6044c441-bde4-09af-e053-2a91aa0a1dfe 70518-0379 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20170331 ANDA ANDA074056 REMEDYREPACK INC. ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0380_4c89fc8a-f1b9-3632-e054-00144ff8d46c 70518-0380 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20170403 ANDA ANDA078888 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 70518-0381_52f73987-d7f4-1c88-e054-00144ff88e88 70518-0381 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20170403 ANDA ANDA076704 REMEDYREPACK INC. METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0382_5c3ef272-bbad-7c2b-e053-2a91aa0acb3b 70518-0382 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20170403 ANDA ANDA077912 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0383_5e7113aa-e5f6-08c8-e053-2991aa0aa564 70518-0383 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20170406 ANDA ANDA091650 REMEDYREPACK INC. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0384_4c7412be-2fa1-40a2-e054-00144ff88e88 70518-0384 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170403 ANDA ANDA065342 REMEDYREPACK INC. CEFTRIAXONE SODIUM 1 g/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 70518-0386_5e7125ad-5975-326b-e053-2a91aa0a821c 70518-0386 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20170413 ANDA ANDA071669 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70518-0387_4c7412be-2fdd-40a2-e054-00144ff88e88 70518-0387 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20170404 ANDA ANDA200839 REMEDYREPACK INC. LEVOFLOXACIN 500 mg/1 N 20181231 70518-0389_5e7125ad-5987-326b-e053-2a91aa0a821c 70518-0389 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170404 ANDA ANDA076159 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0390_4c74e241-a5f4-0b3f-e054-00144ff8d46c 70518-0390 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20170404 ANDA ANDA090478 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70518-0391_4d123293-4843-3391-e054-00144ff8d46c 70518-0391 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20170404 ANDA ANDA090617 REMEDYREPACK INC. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0392_4c76b0b5-b212-55a1-e054-00144ff8d46c 70518-0392 HUMAN PRESCRIPTION DRUG erythromycin erythromycin OINTMENT OPHTHALMIC 20170404 ANDA ANDA062447 REMEDYREPACK INC. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0393_4c89abba-eeb3-13f5-e054-00144ff8d46c 70518-0393 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170404 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0394_54b19980-c046-289c-e054-00144ff8d46c 70518-0394 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20170404 ANDA ANDA077927 REMEDYREPACK INC. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0395_5e712978-32c9-5495-e053-2a91aa0a6f0d 70518-0395 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20170406 ANDA ANDA077056 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 70518-0396_4f1e34e4-085f-5b7c-e054-00144ff8d46c 70518-0396 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20170404 ANDA ANDA090564 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0397_4ceb64ac-f697-6f92-e054-00144ff88e88 70518-0397 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20170404 ANDA ANDA090121 REMEDYREPACK INC. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 70518-0398_4c860e9d-727b-359d-e054-00144ff88e88 70518-0398 HUMAN PRESCRIPTION DRUG Doxazosin mesylate doxazosin mesylate TABLET ORAL 20170404 NDA NDA019668 REMEDYREPACK INC. DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70518-0399_4cef94c8-d6d0-065c-e054-00144ff88e88 70518-0399 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20170404 ANDA ANDA074056 REMEDYREPACK INC. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0400_4d261927-2fe7-4074-e054-00144ff88e88 70518-0400 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET ORAL 20170405 ANDA ANDA202928 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 70518-0401_4c89abba-eee9-13f5-e054-00144ff8d46c 70518-0401 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20170405 ANDA ANDA076008 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 70518-0402_5e714917-ee59-61ab-e053-2a91aa0ac87e 70518-0402 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20170406 ANDA ANDA076071 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0403_4c890190-594e-0512-e054-00144ff88e88 70518-0403 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20170405 ANDA ANDA203270 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0404_514292bf-6aee-0d33-e054-00144ff88e88 70518-0404 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20170406 ANDA ANDA206434 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0405_5e84dd17-573c-62f9-e053-2a91aa0aff98 70518-0405 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20170406 ANDA ANDA078181 REMEDYREPACK INC. GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0406_5e734493-9e6b-4895-e053-2991aa0a7c23 70518-0406 HUMAN PRESCRIPTION DRUG Captopril captopril TABLET ORAL 20170406 ANDA ANDA074434 REMEDYREPACK INC. CAPTOPRIL 25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0407_4c7412be-2edf-40a2-e054-00144ff88e88 70518-0407 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20170405 ANDA ANDA078558 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0408_5179a651-843b-675c-e054-00144ff88e88 70518-0408 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20170406 ANDA ANDA201991 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0409_50ebc53e-1429-34d2-e054-00144ff88e88 70518-0409 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20170407 ANDA ANDA078314 REMEDYREPACK INC. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0410_4c88aa3b-9f0e-0e6a-e054-00144ff88e88 70518-0410 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate SOLUTION/ DROPS OPHTHALMIC 20170406 ANDA ANDA040069 REMEDYREPACK INC. DEXAMETHASONE SODIUM PHOSPHATE 1 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0411_4d7712c7-3f25-3578-e054-00144ff8d46c 70518-0411 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20170407 ANDA ANDA072235 REMEDYREPACK INC. BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 70518-0412_4c965849-a4fb-1b7c-e054-00144ff8d46c 70518-0412 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170407 ANDA ANDA207068 REMEDYREPACK INC. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0413_5037bdfc-a360-533a-e054-00144ff88e88 70518-0413 HUMAN PRESCRIPTION DRUG EPIPEN epinephrine INJECTION INTRAMUSCULAR 20170407 NDA NDA019430 REMEDYREPACK INC. EPINEPHRINE .3 mg/.3mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 70518-0414_6301aa49-bab8-2724-e053-2991aa0a0eb8 70518-0414 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170420 ANDA ANDA075932 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 70518-0415_4cdb2405-04c9-4949-e054-00144ff88e88 70518-0415 HUMAN OTC DRUG Major Regular Strength Assorted Flavors Antacid Tablets TABLET, CHEWABLE ORAL 20170410 OTC MONOGRAPH FINAL part331 REMEDYREPACK INC. CALCIUM CARBONATE 500 mg/1 N 20181231 70518-0416_4cdb95ff-7704-5345-e054-00144ff8d46c 70518-0416 HUMAN PRESCRIPTION DRUG Loxapine Loxapine CAPSULE ORAL 20170410 ANDA ANDA072062 REMEDYREPACK INC. LOXAPINE SUCCINATE 50 mg/1 N 20181231 70518-0417_4da00cd5-953d-512d-e054-00144ff88e88 70518-0417 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20170410 ANDA ANDA078619 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0418_513e911a-e13b-336c-e054-00144ff8d46c 70518-0418 HUMAN PRESCRIPTION DRUG PROMETHAZINE DM Dextromethorphan Hydrobromide and Promethazine Hydrochloride SOLUTION ORAL 20170411 ANDA ANDA040649 REMEDYREPACK INC. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15; 6.25 mg/5mL; mg/5mL Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0419_50d89500-8bab-518f-e054-00144ff88e88 70518-0419 HUMAN PRESCRIPTION DRUG Losartan potassium losartan potassium TABLET, FILM COATED ORAL 20170424 ANDA ANDA077424 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0420_5178fbd7-ac18-43d9-e054-00144ff88e88 70518-0420 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20170425 ANDA ANDA076343 REMEDYREPACK INC. TOPIRAMATE 200 1/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0421_4cfeb88c-84b9-4699-e054-00144ff8d46c 70518-0421 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20170412 ANDA ANDA200294 REMEDYREPACK INC. MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 70518-0422_4cfe7c2c-b791-0106-e054-00144ff88e88 70518-0422 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20170412 ANDA ANDA200294 REMEDYREPACK INC. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 70518-0423_4cfe6210-22c7-36a7-e054-00144ff8d46c 70518-0423 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20170412 ANDA ANDA077987 REMEDYREPACK INC. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0424_5b25f8d5-0226-93f1-e053-2a91aa0af70a 70518-0424 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20170412 ANDA ANDA065061 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 70518-0425_4d9f525d-a63d-64aa-e054-00144ff8d46c 70518-0425 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20170414 ANDA ANDA204279 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 70518-0426_4df046e2-b393-1d0f-e054-00144ff8d46c 70518-0426 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20170417 ANDA ANDA077614 REMEDYREPACK INC. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70518-0427_52929d98-f01d-5351-e054-00144ff88e88 70518-0427 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20170417 ANDA ANDA077309 REMEDYREPACK INC. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 70518-0428_4d64d08d-fa77-7524-e054-00144ff8d46c 70518-0428 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride TABLET ORAL 20170417 ANDA ANDA076690 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0429_4d64d08d-fa5d-7524-e054-00144ff8d46c 70518-0429 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20170417 NDA NDA018877 REMEDYREPACK INC. ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 70518-0430_5e74de46-7766-5b5f-e053-2a91aa0a4215 70518-0430 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20170419 ANDA ANDA076919 REMEDYREPACK INC. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0431_5e750a62-7393-0868-e053-2a91aa0a97d2 70518-0431 HUMAN PRESCRIPTION DRUG Methocarbamol methocarbamol TABLET ORAL 20170419 ANDA ANDA040489 REMEDYREPACK INC. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70518-0432_5fc68935-f06d-c067-e053-2991aa0a2ad6 70518-0432 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20170419 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0433_4d643e74-ddaa-6593-e054-00144ff8d46c 70518-0433 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20170417 ANDA ANDA076000 REMEDYREPACK INC. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0434_4d771c80-7374-34b1-e054-00144ff8d46c 70518-0434 HUMAN PRESCRIPTION DRUG CEFTRIAXONE CEFTRIAXONE INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170418 ANDA ANDA065125 REMEDYREPACK INC. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 70518-0435_4d78d44c-4eaf-71f7-e054-00144ff88e88 70518-0435 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20170418 ANDA ANDA075967 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0436_54b14632-e0d9-0d6e-e054-00144ff8d46c 70518-0436 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20170418 ANDA ANDA206556 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 70518-0437_4d9f9fe4-ed70-4418-e054-00144ff88e88 70518-0437 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20170419 ANDA ANDA090702 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 70518-0438_4da034b2-e7ab-16e5-e054-00144ff8d46c 70518-0438 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20170419 ANDA ANDA203814 REMEDYREPACK INC. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 70518-0439_4d9f9e35-0447-43f2-e054-00144ff88e88 70518-0439 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20170419 ANDA ANDA090939 REMEDYREPACK INC. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0440_4d9f6f02-ffb2-6aa3-e054-00144ff8d46c 70518-0440 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20170419 ANDA ANDA203277 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0441_4d9f6f02-ffa4-6aa3-e054-00144ff8d46c 70518-0441 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20170419 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70518-0442_62ef3743-787c-0d47-e053-2a91aa0a431e 70518-0442 HUMAN PRESCRIPTION DRUG buprenorphine hydrochloride buprenorphine hydrochloride TABLET SUBLINGUAL 20170420 ANDA ANDA090622 REMEDYREPACK INC. BUPRENORPHINE HYDROCHLORIDE 8 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 70518-0443_5e85017c-867a-ae23-e053-2991aa0a231f 70518-0443 HUMAN PRESCRIPTION DRUG medroxyprogesterone acetate medroxyprogesterone acetate TABLET ORAL 20170424 NDA AUTHORIZED GENERIC NDA011839 REMEDYREPACK INC. MEDROXYPROGESTERONE ACETATE 10 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 70518-0444_5e85017c-86c3-ae23-e053-2991aa0a231f 70518-0444 HUMAN OTC DRUG Plus Pharma Pain Reliever,Fever Reducer ACETAMINOPHEN TABLET ORAL 20170424 OTC MONOGRAPH NOT FINAL part343 REMEDYREPACK INC. ACETAMINOPHEN 325 mg/1 N 20181231 70518-0445_4d9f6f02-ff8f-6aa3-e054-00144ff8d46c 70518-0445 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20170420 ANDA ANDA078203 REMEDYREPACK INC. LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0446_4da03f4b-c7f1-5749-e054-00144ff88e88 70518-0446 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20170420 ANDA ANDA203245 REMEDYREPACK INC. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70518-0447_4da05f26-1e16-25c5-e054-00144ff8d46c 70518-0447 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20170420 ANDA ANDA040659 REMEDYREPACK INC. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 70518-0448_4db28298-2947-47dd-e054-00144ff8d46c 70518-0448 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170421 ANDA ANDA075350 REMEDYREPACK INC. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0449_50c3a7ee-04db-363b-e054-00144ff88e88 70518-0449 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20170421 ANDA ANDA077042 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0450_4db2cf57-ee90-55b1-e054-00144ff8d46c 70518-0450 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20170421 ANDA ANDA077438 REMEDYREPACK INC. LEVOFLOXACIN 750 mg/1 N 20181231 70518-0451_4db2cf57-eef1-55b1-e054-00144ff8d46c 70518-0451 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20170421 ANDA ANDA203154 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 70518-0452_4db2cf57-ef0b-55b1-e054-00144ff8d46c 70518-0452 HUMAN PRESCRIPTION DRUG donepezil hydrochloride donepezil hydrochloride TABLET, FILM COATED ORAL 20170421 ANDA ANDA200292 REMEDYREPACK INC. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 70518-0453_5e85033c-35f7-672b-e053-2a91aa0a3a60 70518-0453 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20170424 ANDA ANDA076710 REMEDYREPACK INC. LEVOFLOXACIN 500 mg/1 N 20181231 70518-0454_4defa9ad-2c44-740b-e054-00144ff8d46c 70518-0454 HUMAN PRESCRIPTION DRUG EPINEPHRINE epinephrine INJECTION, SOLUTION INTRAMUSCULAR; SUBCUTANEOUS 20170421 UNAPPROVED DRUG OTHER REMEDYREPACK INC. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 70518-0455_4def7059-7178-369f-e054-00144ff88e88 70518-0455 HUMAN PRESCRIPTION DRUG Spironolactone Spironolactone TABLET ORAL 20170424 ANDA ANDA091426 REMEDYREPACK INC. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 70518-0456_5e855354-4f9e-3d21-e053-2991aa0a20d9 70518-0456 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170424 ANDA ANDA076467 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0457_4def66e0-4cba-6451-e054-00144ff8d46c 70518-0457 HUMAN PRESCRIPTION DRUG Fluphenazine hydrochloride Fluphenazine hydrochloride TABLET, FILM COATED ORAL 20170424 ANDA ANDA089804 REMEDYREPACK INC. FLUPHENAZINE HYDROCHLORIDE 5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0458_4def932d-1c3b-7068-e054-00144ff8d46c 70518-0458 HUMAN PRESCRIPTION DRUG Perphenazine perphenazine TABLET, FILM COATED ORAL 20170424 ANDA ANDA040226 REMEDYREPACK INC. PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0459_5e856a05-81ef-5a6c-e053-2991aa0a218e 70518-0459 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20170509 NDA AUTHORIZED GENERIC NDA016320 REMEDYREPACK INC. ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] N 20181231 70518-0460_4e92cc27-1e22-4472-e054-00144ff8d46c 70518-0460 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20170425 ANDA ANDA075511 REMEDYREPACK INC. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70518-0461_4e956d27-8c46-3f22-e054-00144ff88e88 70518-0461 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20170425 ANDA ANDA075805 REMEDYREPACK INC. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70518-0462_4e92dca7-7ece-7064-e054-00144ff88e88 70518-0462 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20170425 ANDA ANDA091226 REMEDYREPACK INC. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0463_5df654b7-01ad-4e5a-e053-2a91aa0a8063 70518-0463 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20171114 ANDA ANDA078597 REMEDYREPACK INC. DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 70518-0464_4facb266-8b3b-3995-e054-00144ff8d46c 70518-0464 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20170425 ANDA ANDA076639 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 70518-0465_4e92cc27-1d73-4472-e054-00144ff8d46c 70518-0465 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 20170426 ANDA ANDA064067 REMEDYREPACK INC. ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0466_4f0c1ed0-f165-1e61-e054-00144ff88e88 70518-0466 HUMAN OTC DRUG Mucinex Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170427 NDA NDA021282 REMEDYREPACK INC. GUAIFENESIN 600 mg/1 N 20181231 70518-0467_4e958417-5775-46c5-e054-00144ff88e88 70518-0467 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20170427 ANDA ANDA090939 REMEDYREPACK INC. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0468_5e862383-e1d9-7677-e053-2a91aa0ac59e 70518-0468 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170502 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0469_5e869547-4459-8bab-e053-2a91aa0a652c 70518-0469 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20170509 NDA NDA021567 REMEDYREPACK INC. ATAZANAVIR SULFATE 300 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 70518-0470_5df586c9-b944-3724-e053-2991aa0a3122 70518-0470 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20171114 OTC MONOGRAPH NOT FINAL part343 REMEDYREPACK INC. ACETAMINOPHEN 325 mg/1 N 20181231 70518-0471_4ea91219-a699-5bf2-e054-00144ff8d46c 70518-0471 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel bisulphate TABLET, FILM COATED ORAL 20170428 ANDA ANDA202925 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 70518-0472_4ea8f322-ef8a-6109-e054-00144ff88e88 70518-0472 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20170428 ANDA ANDA090939 REMEDYREPACK INC. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0473_4ea90440-ccf7-5c7e-e054-00144ff8d46c 70518-0473 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20170428 ANDA ANDA088832 REMEDYREPACK INC. PREDNISONE 10 mg/1 N 20181231 70518-0475_5e99ffe7-68b5-6a6c-e053-2a91aa0ad8e5 70518-0475 HUMAN OTC DRUG Opcon-A Naphazoline hydrochloride and Pheniramine maleate SOLUTION/ DROPS OPHTHALMIC 20170502 NDA NDA020065 REMEDYREPACK INC. NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .2675; 3.15 mg/mL; mg/mL N 20181231 70518-0476_5e87d151-6a99-8a52-e053-2a91aa0a4a8c 70518-0476 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20170512 ANDA ANDA075798 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 70518-0477_4e92dca7-7e4b-7064-e054-00144ff88e88 70518-0477 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20170502 ANDA ANDA076000 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0478_4ea93c7c-260c-2a35-e054-00144ff8d46c 70518-0478 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170502 ANDA ANDA090174 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0479_5e996a1c-4733-b75a-e053-2a91aa0a3440 70518-0479 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20170516 ANDA ANDA086242 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 70518-0480_4ea8a9a8-dc05-4d7c-e054-00144ff8d46c 70518-0480 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20170503 ANDA ANDA077851 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 70518-0481_575ed830-1b82-7b74-e053-2a91aa0a4a79 70518-0481 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20170503 ANDA ANDA078895 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70518-0482_5e8765e6-c9ac-d552-e053-2991aa0ae9fa 70518-0482 HUMAN PRESCRIPTION DRUG SUSTIVA efavirenz TABLET, FILM COATED ORAL 20170522 NDA NDA021360 REMEDYREPACK INC. EFAVIRENZ 600 mg/1 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [Chemical/Ingredient],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA] N 20181231 70518-0483_616d8fc3-3d43-d56a-e053-2991aa0a4bcd 70518-0483 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20170505 ANDA ANDA202764 REMEDYREPACK INC. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0484_4f0c1ed0-f177-1e61-e054-00144ff88e88 70518-0484 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20170505 ANDA ANDA206434 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0485_5f8f8f79-d159-5d4e-e053-2991aa0ad74e 70518-0485 HUMAN OTC DRUG Biofreeze Roll-On MENTHOL GEL TOPICAL 20170505 OTC MONOGRAPH NOT FINAL part348 REMEDYREPACK INC. MENTHOL 40 mg/mL N 20181231 70518-0486_4f0ba85e-b779-124d-e054-00144ff88e88 70518-0486 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20170508 ANDA ANDA078203 REMEDYREPACK INC. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0487_4f0bbc32-c2dc-0fd9-e054-00144ff88e88 70518-0487 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20170508 ANDA ANDA204279 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 70518-0488_5ae78160-1ab2-f827-e053-2991aa0aa575 70518-0488 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20170508 ANDA ANDA204279 REMEDYREPACK INC. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 70518-0489_5e88776b-1c60-09a9-e053-2991aa0a07e9 70518-0489 HUMAN PRESCRIPTION DRUG Lamotrigine Extended Release lamotrigine extended release TABLET ORAL 20170510 ANDA ANDA201791 REMEDYREPACK INC. LAMOTRIGINE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 70518-0490_5e121e8a-c104-7f86-e053-2a91aa0ac84e 70518-0490 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20171115 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0491_4f0bbc32-c22d-0fd9-e054-00144ff88e88 70518-0491 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20170508 ANDA ANDA090745 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0492_5e884c0d-9598-4615-e053-2991aa0af217 70518-0492 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170510 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0493_4f0b9163-c322-7483-e054-00144ff8d46c 70518-0493 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170508 ANDA ANDA202446 REMEDYREPACK INC. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70518-0494_5e1196aa-19c4-2d6e-e053-2a91aa0ac258 70518-0494 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20171115 ANDA ANDA091624 REMEDYREPACK INC. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0496_5e0f6bf6-adcc-757b-e053-2a91aa0ad5cb 70518-0496 HUMAN PRESCRIPTION DRUG Chlorzoxazone Chlorzoxazone TABLET ORAL 20171115 ANDA ANDA089859 REMEDYREPACK INC. CHLORZOXAZONE 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70518-0498_5e0f6bf6-adbb-757b-e053-2a91aa0ad5cb 70518-0498 HUMAN OTC DRUG mytab For gas Simethicone TABLET, CHEWABLE ORAL 20171115 OTC MONOGRAPH FINAL part332 REMEDYREPACK INC. DIMETHICONE 80 mg/1 N 20181231 70518-0499_5ec12ff6-6f9a-8d58-e053-2a91aa0aefff 70518-0499 HUMAN PRESCRIPTION DRUG Bupivacaine Hydrochloride Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INTRACAUDAL 20170509 ANDA ANDA203895 REMEDYREPACK INC. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 70518-0500_5df38e39-a32d-8519-e053-2991aa0ad6c2 70518-0500 HUMAN PRESCRIPTION DRUG Vistaril hydroxyzine pamoate CAPSULE ORAL 20171114 NDA NDA011459 REMEDYREPACK INC. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 70518-0501_4f235fdf-a25e-5f63-e054-00144ff8d46c 70518-0501 HUMAN PRESCRIPTION DRUG Levaquin levofloxacin TABLET, FILM COATED ORAL 20170509 NDA NDA020634 REMEDYREPACK INC. LEVOFLOXACIN 750 mg/1 N 20181231 70518-0502_5e88776b-1ca1-09a9-e053-2991aa0a07e9 70518-0502 HUMAN PRESCRIPTION DRUG Prevacid lansoprazole CAPSULE, DELAYED RELEASE ORAL 20170512 NDA NDA020406 REMEDYREPACK INC. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 70518-0504_5826842d-1411-0e9f-e053-2991aa0a6b4a 70518-0504 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION INTRAMUSCULAR; INTRAVENOUS 20170509 ANDA ANDA076209 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 70518-0505_592c5ffe-ebd2-4c55-e053-2a91aa0adef3 70518-0505 HUMAN PRESCRIPTION DRUG Zithromax azithromycin dihydrate TABLET, FILM COATED ORAL 20170509 NDA NDA050711 REMEDYREPACK INC. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0506_4f231065-fce6-5617-e054-00144ff8d46c 70518-0506 HUMAN PRESCRIPTION DRUG Betamethasone Sodium Phosphate and Betamethasone Acetate Betamethasone Sodium Phosphate and Betamethasone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR 20170509 ANDA ANDA090747 REMEDYREPACK INC. BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE 3; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0507_4f5f96a5-d2a5-3755-e054-00144ff8d46c 70518-0507 HUMAN PRESCRIPTION DRUG Bacteriostatic Water WATER SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20170509 NDA NDA018802 REMEDYREPACK INC. WATER 1 mL/mL N 20181231 70518-0508_4f231065-fca2-5617-e054-00144ff8d46c 70518-0508 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20170509 NDA NDA021077 REMEDYREPACK INC. SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 500 ug/1; ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 70518-0509_4f5bf1cd-e6d0-405c-e054-00144ff88e88 70518-0509 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate rizatriptan benzoate TABLET ORAL 20170509 ANDA ANDA201993 REMEDYREPACK INC. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 70518-0510_5e892509-eba8-0c8f-e053-2991aa0a038e 70518-0510 HUMAN PRESCRIPTION DRUG Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE ORAL 20170512 ANDA ANDA076546 REMEDYREPACK INC. TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20181231 70518-0511_4faccb64-e2f6-5617-e054-00144ff8d46c 70518-0511 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION INFILTRATION; PERINEURAL 20170509 ANDA ANDA088586 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 70518-0512_5916bdd5-9766-e6f5-e053-2991aa0af32c 70518-0512 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170913 ANDA ANDA078321 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0513_5d962500-6632-3c28-e053-2a91aa0af1b9 70518-0513 HUMAN PRESCRIPTION DRUG Lamivudine lamivudine TABLET, FILM COATED ORAL 20170509 ANDA ANDA204528 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0514_4f4b2ad9-4912-002e-e054-00144ff88e88 70518-0514 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20170510 NDA NDA021077 REMEDYREPACK INC. SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 100 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0515_4f4b2ad9-48ee-002e-e054-00144ff88e88 70518-0515 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20170510 ANDA ANDA201807 REMEDYREPACK INC. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0516_4f4b2ad9-48a5-002e-e054-00144ff88e88 70518-0516 HUMAN PRESCRIPTION DRUG Depo-Medrol methylprednisolone acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20170510 NDA NDA011757 REMEDYREPACK INC. METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0517_4f5bb475-e73f-3a3b-e054-00144ff88e88 70518-0517 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20170510 ANDA ANDA079162 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0518_592c354e-4f0e-0ff7-e053-2a91aa0a41ca 70518-0518 HUMAN PRESCRIPTION DRUG Flomax tamsulosin hydrochloride CAPSULE ORAL 20170515 NDA NDA020579 REMEDYREPACK INC. TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70518-0519_592c354e-4ef6-0ff7-e053-2a91aa0a41ca 70518-0519 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET ORAL 20170515 ANDA ANDA040712 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0520_5f2b7afc-a335-763c-e053-2991aa0ad839 70518-0520 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20170510 NDA AUTHORIZED GENERIC NDA018998 REMEDYREPACK INC. ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70518-0521_5e8a7d4a-9fdf-467f-e053-2991aa0a8362 70518-0521 HUMAN PRESCRIPTION DRUG Xylocaine MPF LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL 20170512 NDA NDA006488 REMEDYREPACK INC. LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 70518-0522_4f4ad93a-6957-5d54-e054-00144ff8d46c 70518-0522 HUMAN PRESCRIPTION DRUG Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS TOPICAL 20170511 ANDA ANDA077689 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 3.5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 70518-0523_4f4872a4-2a54-232b-e054-00144ff88e88 70518-0523 HUMAN OTC DRUG Mucinex D Guaifenesin and Pseudoephedrine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20170511 NDA NDA021585 REMEDYREPACK INC. GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE 600; 60 mg/1; mg/1 N 20181231 70518-0524_589edd23-c4d6-de1d-e053-2991aa0a5e99 70518-0524 HUMAN OTC DRUG Ear Drops Major Carbamide Peroxide 6.5% LIQUID AURICULAR (OTIC) 20170511 OTC MONOGRAPH FINAL part344 REMEDYREPACK INC. CARBAMIDE PEROXIDE 6.5 g/100mL N 20181231 70518-0525_4f4872a4-2a67-232b-e054-00144ff88e88 70518-0525 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20170511 OTC MONOGRAPH FINAL part341 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 70518-0526_504be875-0594-5871-e054-00144ff88e88 70518-0526 HUMAN PRESCRIPTION DRUG levalbuterol hydrochloride levalbuterol hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170512 ANDA ANDA077756 REMEDYREPACK INC. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20191231 70518-0527_4f5ba9d1-a474-6b99-e054-00144ff8d46c 70518-0527 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20170512 ANDA ANDA204239 REMEDYREPACK INC. LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 70518-0528_5e8aa565-0f1a-2ba0-e053-2a91aa0a65aa 70518-0528 HUMAN PRESCRIPTION DRUG Epinephrine EPINEPHRINE INJECTION, SOLUTION ENDOTRACHEAL; INTRACARDIAC; INTRAVENOUS 20170512 UNAPPROVED DRUG OTHER REMEDYREPACK INC. EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 70518-0529_5e8aa565-0f28-2ba0-e053-2a91aa0a65aa 70518-0529 HUMAN PRESCRIPTION DRUG ATROPINE SULFATE ATROPINE SULFATE INJECTION, SOLUTION INTRAVENOUS 20170512 NDA NDA021146 REMEDYREPACK INC. ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 70518-0530_50c380e7-3441-2a6a-e054-00144ff8d46c 70518-0530 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20170512 ANDA ANDA076180 REMEDYREPACK INC. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0531_4f9a560a-6e18-7303-e054-00144ff8d46c 70518-0531 HUMAN PRESCRIPTION DRUG Mometasone Furoate Mometasone Furoate OINTMENT TOPICAL 20170512 ANDA ANDA077401 REMEDYREPACK INC. MOMETASONE FUROATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0532_5c5152a6-fb8f-4015-e053-2a91aa0a9dc9 70518-0532 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION INTRAMUSCULAR; INTRAVENOUS 20170515 ANDA ANDA087702 REMEDYREPACK INC. DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0533_4f99cbd9-ff40-02a0-e054-00144ff88e88 70518-0533 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20170515 ANDA ANDA074806 REMEDYREPACK INC. PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] N 20181231 70518-0534_4f9a560a-6dec-7303-e054-00144ff8d46c 70518-0534 HUMAN PRESCRIPTION DRUG Labetalol HCl Labetalol HCl TABLET, FILM COATED ORAL 20170515 ANDA ANDA075113 REMEDYREPACK INC. LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0535_55a7039a-10d0-219b-e054-00144ff8d46c 70518-0535 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20170515 ANDA ANDA078558 REMEDYREPACK INC. IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0536_4f998068-e00a-4dd6-e054-00144ff8d46c 70518-0536 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20170515 ANDA ANDA090200 REMEDYREPACK INC. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70518-0537_4f99e001-5e59-5f6d-e054-00144ff8d46c 70518-0537 HUMAN OTC DRUG omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20170515 NDA NDA022032 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 N 20181231 70518-0538_4f9a3bc4-a30c-6e2c-e054-00144ff8d46c 70518-0538 HUMAN PRESCRIPTION DRUG ADVAIR DISKUS fluticasone propionate and salmeterol POWDER RESPIRATORY (INHALATION) 20170515 NDA NDA021077 REMEDYREPACK INC. SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE 50; 250 ug/1; ug/1 Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0539_5e8b9ff6-4efc-49ff-e053-2991aa0aa1d6 70518-0539 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole GEL VAGINAL 20170515 ANDA ANDA077264 REMEDYREPACK INC. METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 70518-0540_4f9a1458-457d-0713-e054-00144ff88e88 70518-0540 HUMAN PRESCRIPTION DRUG Lamivudine lamivudine TABLET, FILM COATED ORAL 20170515 ANDA ANDA204528 REMEDYREPACK INC. LAMIVUDINE 300 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0541_4f9a1458-45ec-0713-e054-00144ff88e88 70518-0541 HUMAN PRESCRIPTION DRUG Valacyclovir Hydrochloride valacyclovir hydrochloride TABLET, FILM COATED ORAL 20170515 ANDA ANDA078518 REMEDYREPACK INC. VALACYCLOVIR HYDROCHLORIDE 1 g/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 70518-0542_4fe64728-34c1-11ec-e054-00144ff88e88 70518-0542 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20170517 ANDA ANDA078216 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0544_5e8bc71c-90de-95dc-e053-2a91aa0aba0f 70518-0544 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170519 ANDA ANDA077321 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0545_58992307-a897-7940-e053-2991aa0a8daa 70518-0545 HUMAN PRESCRIPTION DRUG Nitroglycerin Nitroglycerin TABLET SUBLINGUAL 20170907 ANDA ANDA208191 REMEDYREPACK INC. NITROGLYCERIN .4 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 70518-0546_4fd455b2-031b-049f-e054-00144ff8d46c 70518-0546 HUMAN PRESCRIPTION DRUG Viread TENOFOVIR DISOPROXIL FUMARATE TABLET, COATED ORAL 20170518 NDA NDA021356 REMEDYREPACK INC. TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0547_529664de-3912-4ce9-e054-00144ff88e88 70518-0547 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20170518 ANDA ANDA072234 REMEDYREPACK INC. BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 70518-0548_4fe64728-34a9-11ec-e054-00144ff88e88 70518-0548 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20170519 ANDA ANDA090200 REMEDYREPACK INC. METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70518-0549_4fe64728-3468-11ec-e054-00144ff88e88 70518-0549 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170519 ANDA ANDA076341 REMEDYREPACK INC. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0550_504c0f1c-b03c-4aae-e054-00144ff8d46c 70518-0550 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20170522 ANDA ANDA203854 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0551_505fc5e3-2ce3-5170-e054-00144ff88e88 70518-0551 HUMAN PRESCRIPTION DRUG ZYLOPRIM allopurinol TABLET ORAL 20170525 NDA NDA016084 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 70518-0552_5898d0fa-c3ca-06c9-e053-2991aa0a6017 70518-0552 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20170907 ANDA ANDA075795 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0553_505ff11d-e044-1f90-e054-00144ff8d46c 70518-0553 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20170525 ANDA ANDA077511 REMEDYREPACK INC. TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 70518-0554_505fc5e3-2cbc-5170-e054-00144ff88e88 70518-0554 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20170525 ANDA ANDA090515 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0555_505fc5e3-2ca4-5170-e054-00144ff88e88 70518-0555 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20170525 NDA NDA018832 REMEDYREPACK INC. ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 70518-0556_50600f86-5eb9-51c4-e054-00144ff88e88 70518-0556 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20170525 ANDA ANDA201190 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0557_588470ae-81a9-d52d-e053-2a91aa0ae837 70518-0557 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20170906 ANDA ANDA078243 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0558_50c37e0d-6087-319f-e054-00144ff88e88 70518-0558 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170530 ANDA ANDA090174 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0559_50ebc53e-1458-34d2-e054-00144ff88e88 70518-0559 HUMAN PRESCRIPTION DRUG Abacavir Abacavir TABLET, FILM COATED ORAL 20170530 ANDA ANDA077844 REMEDYREPACK INC. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0560_5ae79885-1724-364b-e053-2a91aa0afcc6 70518-0560 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20170601 ANDA ANDA077731 REMEDYREPACK INC. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 70518-0561_50ebadea-184d-316b-e054-00144ff88e88 70518-0561 HUMAN PRESCRIPTION DRUG Citalopram citalopram TABLET, FILM COATED ORAL 20170601 ANDA ANDA077042 REMEDYREPACK INC. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0562_510340c5-ed7b-2dfb-e054-00144ff8d46c 70518-0562 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20170601 ANDA ANDA078423 REMEDYREPACK INC. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 70518-0563_5101fced-e197-0ac2-e054-00144ff8d46c 70518-0563 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170602 ANDA ANDA089424 REMEDYREPACK INC. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 70518-0564_513f4490-7bd7-4cda-e054-00144ff88e88 70518-0564 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20170605 ANDA ANDA078384 REMEDYREPACK INC. CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70518-0565_513f4490-7bb5-4cda-e054-00144ff88e88 70518-0565 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20170605 ANDA ANDA206553 REMEDYREPACK INC. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 70518-0567_5178fbd7-ac1b-43d9-e054-00144ff88e88 70518-0567 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20170606 ANDA ANDA091226 REMEDYREPACK INC. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0568_5e99c787-c5bf-173f-e053-2991aa0a54bf 70518-0568 HUMAN PRESCRIPTION DRUG Genvoya elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide TABLET ORAL 20170607 NDA NDA207561 REMEDYREPACK INC. ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 150; 150; 200; 10 mg/1; mg/1; mg/1; mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0569_51787086-0c6c-2905-e054-00144ff88e88 70518-0569 HUMAN PRESCRIPTION DRUG Trihexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride TABLET ORAL 20170606 ANDA ANDA091630 REMEDYREPACK INC. TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg/1 N 20181231 70518-0570_5da8d632-d5b7-b082-e053-2a91aa0a7fe3 70518-0570 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20170906 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0571_5168ee5d-6c50-1930-e054-00144ff88e88 70518-0571 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20170607 ANDA ANDA071523 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 70518-0572_51c8da9c-5f07-2ed3-e054-00144ff88e88 70518-0572 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium SOLUTION TOPICAL 20170612 ANDA ANDA202027 REMEDYREPACK INC. DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0573_5e99c787-c65e-173f-e053-2991aa0a54bf 70518-0573 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20170612 ANDA ANDA076286 REMEDYREPACK INC. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70518-0574_5b25f8d5-01f1-93f1-e053-2a91aa0af70a 70518-0574 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20170614 ANDA ANDA074550 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0575_5e99ffe7-68cb-6a6c-e053-2a91aa0ad8e5 70518-0575 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20170615 ANDA ANDA076071 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0576_51f1cd9d-43e4-6186-e054-00144ff8d46c 70518-0576 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170614 ANDA ANDA202519 REMEDYREPACK INC. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0577_528112d9-8334-63c4-e054-00144ff88e88 70518-0577 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20170619 ANDA ANDA090168 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 70518-0578_52811025-42e5-5a99-e054-00144ff88e88 70518-0578 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20170619 ANDA ANDA090168 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 70518-0579_526b7521-c6ce-6f4b-e054-00144ff88e88 70518-0579 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20170620 ANDA ANDA075795 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0580_526b8a1c-55a2-71f6-e054-00144ff88e88 70518-0580 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 20170620 NDA NDA018487 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70518-0581_526b3052-2ecc-6569-e054-00144ff88e88 70518-0581 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20170620 ANDA ANDA077293 REMEDYREPACK INC. FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70518-0582_52812f43-d42c-053a-e054-00144ff8d46c 70518-0582 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20170621 ANDA ANDA077614 REMEDYREPACK INC. CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70518-0583_52811025-42a9-5a99-e054-00144ff88e88 70518-0583 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20170621 ANDA ANDA078155 REMEDYREPACK INC. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0584_52811025-4286-5a99-e054-00144ff88e88 70518-0584 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20170621 NDA NDA018569 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70518-0585_5424fab4-e4d1-4649-e054-00144ff88e88 70518-0585 HUMAN OTC DRUG Stool Softener Docusate Sodium DOCUSATE SODIUM CAPSULE, GELATIN COATED ORAL 20170629 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. DOCUSATE SODIUM 100 mg/1 N 20181231 70518-0586_52a69ccc-6a38-30f7-e054-00144ff8d46c 70518-0586 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20170623 ANDA ANDA090467 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0587_52f6c9ad-e72a-2123-e054-00144ff8d46c 70518-0587 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20170626 ANDA ANDA202801 REMEDYREPACK INC. LEVOFLOXACIN 500 mg/1 N 20181231 70518-0588_5c7d6e1d-d8b0-533d-e053-2a91aa0a3cca 70518-0588 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20170627 ANDA ANDA090467 REMEDYREPACK INC. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0589_52f7160e-8f27-4425-e054-00144ff8d46c 70518-0589 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20170627 ANDA ANDA074578 REMEDYREPACK INC. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 70518-0590_530c0158-14f1-112c-e054-00144ff8d46c 70518-0590 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170627 ANDA ANDA075743 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0591_52fcbaa4-0a87-5479-e054-00144ff88e88 70518-0591 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20170627 ANDA ANDA075927 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0592_52fc3fd2-7d1d-4493-e054-00144ff8d46c 70518-0592 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20170627 ANDA ANDA075480 REMEDYREPACK INC. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70518-0593_52fc5fbd-81be-4f34-e054-00144ff8d46c 70518-0593 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 20170627 ANDA ANDA078391 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0594_52fcbaa4-0a35-5479-e054-00144ff88e88 70518-0594 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20170627 ANDA ANDA201190 REMEDYREPACK INC. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0595_52fbac33-2a55-2d6b-e054-00144ff8d46c 70518-0595 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 20170627 ANDA ANDA080937 REMEDYREPACK INC. ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20181231 70518-0596_52fc3fd2-7d09-4493-e054-00144ff8d46c 70518-0596 HUMAN PRESCRIPTION DRUG naproxen naproxen TABLET ORAL 20170627 ANDA ANDA091305 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0597_530b25a6-270b-543e-e054-00144ff88e88 70518-0597 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20170628 ANDA ANDA083177 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0598_53fe0ed6-636e-513a-e054-00144ff8d46c 70518-0598 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20170628 ANDA ANDA065243 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 70518-0599_5e0f1e69-318b-18f8-e053-2a91aa0acd5e 70518-0599 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20170628 ANDA ANDA065223 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0600_531f7f3b-160f-128e-e054-00144ff8d46c 70518-0600 HUMAN PRESCRIPTION DRUG Procardia XL nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170628 NDA NDA019684 REMEDYREPACK INC. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70518-0601_531f7f3b-15e9-128e-e054-00144ff8d46c 70518-0601 HUMAN PRESCRIPTION DRUG Ceftriaxone Ceftriaxone INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170629 ANDA ANDA065230 REMEDYREPACK INC. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 70518-0602_531f4afb-4a66-071d-e054-00144ff8d46c 70518-0602 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170629 ANDA ANDA077157 REMEDYREPACK INC. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0603_531f5f49-ab9b-2007-e054-00144ff88e88 70518-0603 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170629 ANDA ANDA203253 REMEDYREPACK INC. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 70518-0604_536f6de8-5970-040e-e054-00144ff8d46c 70518-0604 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20170630 ANDA ANDA076262 REMEDYREPACK INC. LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0605_536f6de8-593e-040e-e054-00144ff8d46c 70518-0605 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170703 ANDA ANDA090700 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70518-0606_539681cc-add7-00bc-e054-00144ff8d46c 70518-0606 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20170705 ANDA ANDA075967 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0607_53b161d4-eae9-3494-e054-00144ff8d46c 70518-0607 HUMAN PRESCRIPTION DRUG VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20170706 ANDA ANDA206083 REMEDYREPACK INC. VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0608_53b1c6e2-ec9e-4a02-e054-00144ff8d46c 70518-0608 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate TABLET, EXTENDED RELEASE ORAL 20170706 ANDA ANDA204779 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 70518-0609_60316b2b-db3a-2707-e053-2a91aa0a09c4 70518-0609 HUMAN PRESCRIPTION DRUG FOLIC ACID folic acid TABLET ORAL 20170706 ANDA ANDA204418 REMEDYREPACK INC. FOLIC ACID 1 mg/1 N 20181231 70518-0610_53b15358-8c0e-31be-e054-00144ff8d46c 70518-0610 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine KETOROLAC TROMETHAMINE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170706 ANDA ANDA074802 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 70518-0611_53fd6860-3657-2c30-e054-00144ff8d46c 70518-0611 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170707 ANDA ANDA077298 REMEDYREPACK INC. METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0613_5424c65b-e809-3de2-e054-00144ff88e88 70518-0613 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, EXTENDED RELEASE ORAL 20170712 ANDA ANDA090070 REMEDYREPACK INC. DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 70518-0614_542462c0-1572-40f2-e054-00144ff8d46c 70518-0614 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20170712 ANDA ANDA075280 REMEDYREPACK INC. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0615_549dcd7e-c95c-07a7-e054-00144ff88e88 70518-0615 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20170712 ANDA ANDA076255 REMEDYREPACK INC. OLANZAPINE 2.5 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0616_549de40f-043e-0b08-e054-00144ff88e88 70518-0616 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20170712 ANDA ANDA076133 REMEDYREPACK INC. OLANZAPINE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0617_549d9cc4-13b8-57ad-e054-00144ff8d46c 70518-0617 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20170712 ANDA ANDA070581 REMEDYREPACK INC. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 70518-0618_543d59cd-da34-412a-e054-00144ff88e88 70518-0618 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20170713 NDA NDA021446 REMEDYREPACK INC. PREGABALIN 200 mg/1 N 20181231 70518-0619_5bc4529a-581e-710c-e053-2991aa0abb0b 70518-0619 HUMAN PRESCRIPTION DRUG Lyrica PREGABALIN CAPSULE ORAL 20170713 NDA NDA021446 REMEDYREPACK INC. PREGABALIN 75 mg/1 N 20181231 70518-0621_549d6c01-4d0b-4e25-e054-00144ff8d46c 70518-0621 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170717 ANDA ANDA084916 REMEDYREPACK INC. DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0622_5bc463ad-e0c4-6c14-e053-2a91aa0a3871 70518-0622 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20170717 ANDA ANDA077824 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70518-0623_549dcd7e-c8fd-07a7-e054-00144ff88e88 70518-0623 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 20170717 ANDA ANDA075480 REMEDYREPACK INC. ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70518-0624_549d9c2c-0473-4f47-e054-00144ff8d46c 70518-0624 HUMAN PRESCRIPTION DRUG Vasotec Enalapril Maleate TABLET ORAL 20170717 NDA NDA018998 REMEDYREPACK INC. ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70518-0625_566a3315-d361-0d51-e054-00144ff88e88 70518-0625 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20170810 ANDA ANDA076343 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0626_549d6c01-4cd7-4e25-e054-00144ff8d46c 70518-0626 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20170718 ANDA ANDA076958 REMEDYREPACK INC. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0627_5c428dbe-1b69-c72b-e053-2991aa0a3d91 70518-0627 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20170718 ANDA ANDA075185 REMEDYREPACK INC. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0629_5518f5d1-a850-379e-e054-00144ff8d46c 70518-0629 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate Extended-Release Tablet TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170719 NDA AUTHORIZED GENERIC NDA018027 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 70518-0630_551856ee-8671-56fc-e054-00144ff88e88 70518-0630 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170720 ANDA ANDA203512 REMEDYREPACK INC. SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 70518-0631_5517aa54-1388-7400-e054-00144ff8d46c 70518-0631 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20170721 ANDA ANDA077537 REMEDYREPACK INC. GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0632_5517aa54-13a4-7400-e054-00144ff8d46c 70518-0632 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20170721 ANDA ANDA040362 REMEDYREPACK INC. PREDNISONE 5 mg/1 N 20181231 70518-0633_55179cfc-9de7-6e85-e054-00144ff8d46c 70518-0633 HUMAN PRESCRIPTION DRUG Gentak Gentamicin Sulfate OINTMENT OPHTHALMIC 20170724 ANDA ANDA064093 REMEDYREPACK INC. GENTAMICIN SULFATE 3 mg/g Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 70518-0635_63139afe-511c-ae4a-e053-2991aa0a48f0 70518-0635 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20170725 ANDA ANDA090478 REMEDYREPACK INC. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 70518-0636_5c7d6e1d-d809-533d-e053-2a91aa0a3cca 70518-0636 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20170725 ANDA ANDA078250 REMEDYREPACK INC. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0637_552b806d-97d8-364d-e054-00144ff8d46c 70518-0637 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20170725 ANDA ANDA088467 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 70518-0638_552b806d-97f4-364d-e054-00144ff8d46c 70518-0638 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20170725 ANDA ANDA202674 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0639_552b806d-979a-364d-e054-00144ff8d46c 70518-0639 HUMAN PRESCRIPTION DRUG WELLBUTRIN SR bupropion hydrochloride TABLET, FILM COATED ORAL 20170725 NDA NDA020358 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 70518-0640_553e9f30-3e80-4d21-e054-00144ff8d46c 70518-0640 HUMAN PRESCRIPTION DRUG Abacavir Sulfate Abacavir Sulfate TABLET, FILM COATED ORAL 20170726 ANDA ANDA201570 REMEDYREPACK INC. ABACAVIR SULFATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0641_55a3641a-a41e-0a0e-e054-00144ff8d46c 70518-0641 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20170728 ANDA ANDA076008 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20181231 70518-0642_55a2e78a-7fe8-6be7-e054-00144ff8d46c 70518-0642 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20170728 ANDA ANDA075049 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0643_55a313bd-fdb9-483f-e054-00144ff88e88 70518-0643 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20170728 ANDA ANDA076008 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 70518-0644_55a41a36-93e9-2921-e054-00144ff8d46c 70518-0644 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20170728 ANDA ANDA075150 REMEDYREPACK INC. CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0645_55a5a95a-eeb4-6eb9-e054-00144ff8d46c 70518-0645 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20170728 ANDA ANDA201504 REMEDYREPACK INC. QUETIAPINE FUMARATE 50 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0646_55a5a95a-eeb1-6eb9-e054-00144ff8d46c 70518-0646 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Extended Release Quetiapine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170728 NDA AUTHORIZED GENERIC NDA022047 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0647_55a41a36-9455-2921-e054-00144ff8d46c 70518-0647 HUMAN PRESCRIPTION DRUG temazepam temazepam CAPSULE ORAL 20170728 ANDA ANDA071456 REMEDYREPACK INC. TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0648_55a40688-761c-6e7b-e054-00144ff88e88 70518-0648 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, EXTENDED RELEASE ORAL 20170728 ANDA ANDA091399 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0649_55a31f73-da12-4b77-e054-00144ff88e88 70518-0649 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20170728 ANDA ANDA090168 REMEDYREPACK INC. BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 70518-0650_55cb1489-8bf1-4b50-e054-00144ff88e88 70518-0650 HUMAN OTC DRUG Regular Strength Pain Relief Acetaminophen TABLET ORAL 20170728 OTC MONOGRAPH NOT FINAL part343 REMEDYREPACK INC. ACETAMINOPHEN 325 mg/1 N 20181231 70518-0651_63296cc5-9ea9-ede9-e053-2991aa0a3cb7 70518-0651 HUMAN OTC DRUG Aspir Low Aspirin TABLET ORAL 20170728 OTC MONOGRAPH FINAL part343 REMEDYREPACK INC. ASPIRIN 81 mg/1 N 20191231 70518-0652_5fdaa308-63cd-2f85-e053-2a91aa0a032a 70518-0652 HUMAN PRESCRIPTION DRUG Buprenorphine Hydrochloride Sublingual buprenorphine hydrochloride sublingual TABLET SUBLINGUAL 20170731 ANDA ANDA201066 REMEDYREPACK INC. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 70518-0653_55a2ff2e-bbe4-6e8f-e054-00144ff8d46c 70518-0653 HUMAN OTC DRUG Loratadine and Pseudoephedrine loratadine and pseudoephedrine TABLET, EXTENDED RELEASE ORAL 20170731 ANDA ANDA076557 REMEDYREPACK INC. LORATADINE; PSEUDOEPHEDRINE SULFATE 10; 240 mg/1; mg/1 N 20181231 70518-0654_566bfc71-cd5f-4035-e054-00144ff88e88 70518-0654 HUMAN PRESCRIPTION DRUG Ondansetron ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170731 ANDA ANDA077548 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 70518-0655_55b716f2-1f04-18ea-e054-00144ff88e88 70518-0655 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170801 ANDA ANDA076862 REMEDYREPACK INC. METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0656_55b716f2-1eb4-18ea-e054-00144ff88e88 70518-0656 HUMAN PRESCRIPTION DRUG RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20170801 ANDA ANDA078964 REMEDYREPACK INC. RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 70518-0657_55ca7ef4-9ba9-27dc-e054-00144ff88e88 70518-0657 HUMAN OTC DRUG MILK OF MAGNESIA MINT magnesium hydroxide LIQUID ORAL 20170801 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 70518-0658_55b6f694-0996-5dfd-e054-00144ff8d46c 70518-0658 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20170801 ANDA ANDA203145 REMEDYREPACK INC. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0659_55cb1c14-44bf-48e8-e054-00144ff8d46c 70518-0659 HUMAN PRESCRIPTION DRUG Ceftriaxone Sodium Ceftriaxone Sodium INJECTION, POWDER, FOR SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170802 ANDA ANDA065169 REMEDYREPACK INC. CEFTRIAXONE SODIUM 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 70518-0661_55cb0f83-6038-3d00-e054-00144ff8d46c 70518-0661 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20170802 ANDA ANDA076059 REMEDYREPACK INC. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0662_56448881-decd-3cbe-e054-00144ff88e88 70518-0662 HUMAN OTC DRUG Bisacodyl Enteric Coated Bisacodyl TABLET, COATED ORAL 20170803 OTC MONOGRAPH NOT FINAL part334 REMEDYREPACK INC. BISACODYL 5 mg/1 N 20191231 70518-0663_56448881-deba-3cbe-e054-00144ff88e88 70518-0663 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride Chlordiazepoxide Hydrochloride CAPSULE, GELATIN COATED ORAL 20170803 ANDA ANDA085475 REMEDYREPACK INC. CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70518-0664_589f12ed-f756-c819-e053-2a91aa0acd82 70518-0664 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20170808 ANDA ANDA077946 REMEDYREPACK INC. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 70518-0665_5657a947-5491-66c4-e054-00144ff8d46c 70518-0665 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170809 ANDA ANDA203253 REMEDYREPACK INC. SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20181231 70518-0666_566c03fe-40a9-4228-e054-00144ff88e88 70518-0666 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20170810 ANDA ANDA086242 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 70518-0667_566c03fe-4086-4228-e054-00144ff88e88 70518-0667 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20170810 ANDA ANDA075640 REMEDYREPACK INC. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0668_566bfc71-cdc6-4035-e054-00144ff88e88 70518-0668 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20170810 ANDA ANDA079139 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 70518-0669_574970ca-d00f-76d8-e053-2991aa0ac146 70518-0669 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20170814 ANDA ANDA070184 REMEDYREPACK INC. METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 70518-0670_574b6d78-3293-a23d-e053-2a91aa0a6f06 70518-0670 HUMAN OTC DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride CREAM TOPICAL 20170816 ANDA ANDA077511 REMEDYREPACK INC. TERBINAFINE HYDROCHLORIDE 1 g/100g N 20181231 70518-0671_574b2f7d-5665-9d6f-e053-2a91aa0a9317 70518-0671 HUMAN PRESCRIPTION DRUG Flunisolide Flunisolide SOLUTION NASAL 20170816 ANDA ANDA074805 REMEDYREPACK INC. FLUNISOLIDE .25 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0672_574ab457-3460-092a-e053-2a91aa0a96ab 70518-0672 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20170816 ANDA ANDA091184 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0673_574ab457-341f-092a-e053-2a91aa0a96ab 70518-0673 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170816 ANDA ANDA205064 REMEDYREPACK INC. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0674_574bd82c-5704-516d-e053-2a91aa0af4f6 70518-0674 HUMAN PRESCRIPTION DRUG Stribild elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20170816 NDA NDA203100 REMEDYREPACK INC. ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE 150; 150; 200; 300 mg/1; mg/1; mg/1; mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0675_574a592d-d4fe-25fe-e053-2a91aa0a1fd1 70518-0675 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170816 ANDA ANDA206383 REMEDYREPACK INC. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0676_5749d42e-1ff3-7e07-e053-2a91aa0ad5e9 70518-0676 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170816 ANDA ANDA205064 REMEDYREPACK INC. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0677_574bd82c-565e-516d-e053-2a91aa0af4f6 70518-0677 HUMAN PRESCRIPTION DRUG COMPLERA emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate TABLET, FILM COATED ORAL 20170816 NDA NDA202123 REMEDYREPACK INC. EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE 200; 25; 300 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [Chemical/Ingredient],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0678_57498223-cd34-2487-e053-2a91aa0ac74f 70518-0678 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170816 ANDA ANDA078608 REMEDYREPACK INC. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0679_574bd82c-561f-516d-e053-2a91aa0af4f6 70518-0679 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20170816 ANDA ANDA077206 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0680_5749cb89-28dc-8896-e053-2a91aa0abf01 70518-0680 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20170816 ANDA ANDA202330 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 70518-0681_574f48d8-fd4f-553f-e053-2a91aa0a2a7d 70518-0681 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride buspirone hydrochloride TABLET ORAL 20170816 ANDA ANDA076008 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 70518-0682_574bd82c-55d3-516d-e053-2a91aa0af4f6 70518-0682 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20170816 ANDA ANDA202330 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 70518-0683_574d30de-2361-7bf7-e053-2a91aa0ab244 70518-0683 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20170816 ANDA ANDA205064 REMEDYREPACK INC. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0684_574bd82c-559c-516d-e053-2a91aa0af4f6 70518-0684 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20170816 ANDA ANDA078605 REMEDYREPACK INC. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 70518-0685_574c7882-58a4-961f-e053-2a91aa0a2f07 70518-0685 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20170816 ANDA ANDA090778 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0686_574c4d15-4865-c4a0-e053-2991aa0ae0f1 70518-0686 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20170816 ANDA ANDA202045 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0687_574bd82c-579d-516d-e053-2a91aa0af4f6 70518-0687 HUMAN PRESCRIPTION DRUG Lopid gemfibrozil TABLET, FILM COATED ORAL 20170816 NDA NDA018422 REMEDYREPACK INC. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 70518-0688_574b7d34-e027-caaa-e053-2a91aa0ade43 70518-0688 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20170817 NDA NDA021567 REMEDYREPACK INC. ATAZANAVIR SULFATE 150 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 70518-0689_574f81fc-3c20-8b2a-e053-2991aa0a8c20 70518-0689 HUMAN PRESCRIPTION DRUG PREZISTA darunavir TABLET, FILM COATED ORAL 20170817 NDA NDA021976 REMEDYREPACK INC. DARUNAVIR ETHANOLATE 600 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] N 20181231 70518-0690_574bd82c-5570-516d-e053-2a91aa0af4f6 70518-0690 HUMAN PRESCRIPTION DRUG Lamivudine Lamivudine TABLET, FILM COATED ORAL 20170817 ANDA ANDA202032 REMEDYREPACK INC. LAMIVUDINE 150 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0691_574f48d8-fd97-553f-e053-2a91aa0a2a7d 70518-0691 HUMAN PRESCRIPTION DRUG EPZICOM abacavir sulfate and lamivudine TABLET, FILM COATED ORAL 20170817 NDA NDA021652 REMEDYREPACK INC. ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0692_574f711f-737c-ff27-e053-2a91aa0a0708 70518-0692 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20170817 ANDA ANDA076765 REMEDYREPACK INC. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0693_574f81fc-3cad-8b2a-e053-2991aa0a8c20 70518-0693 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20170817 ANDA ANDA075593 REMEDYREPACK INC. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 70518-0694_575e5230-99a9-b3ff-e053-2a91aa0a49b4 70518-0694 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20170817 ANDA ANDA203126 REMEDYREPACK INC. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70518-0695_575e629d-c8d8-1a63-e053-2991aa0ae40b 70518-0695 HUMAN PRESCRIPTION DRUG ODEFSEY emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide TABLET ORAL 20170817 NDA NDA208351 REMEDYREPACK INC. EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE 200; 25; 25 mg/1; mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [Chemical/Ingredient],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0696_575e629d-c8be-1a63-e053-2991aa0ae40b 70518-0696 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20170818 ANDA ANDA077839 REMEDYREPACK INC. ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 70518-0697_575e629d-c88e-1a63-e053-2991aa0ae40b 70518-0697 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20170818 ANDA ANDA079081 REMEDYREPACK INC. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0698_575e2630-eac3-8e56-e053-2a91aa0a9a35 70518-0698 HUMAN PRESCRIPTION DRUG Nabumetone Nabumentone TABLET ORAL 20170818 ANDA ANDA075280 REMEDYREPACK INC. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0699_63141c5d-15c9-649b-e053-2a91aa0adf06 70518-0699 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 20170818 OTC MONOGRAPH NOT FINAL part343 REMEDYREPACK INC. ASPIRIN 81 mg/1 N 20191231 70518-0700_575e2630-ea5f-8e56-e053-2a91aa0a9a35 70518-0700 HUMAN PRESCRIPTION DRUG Fenofibrate Fenofibrate TABLET ORAL 20170818 ANDA ANDA204019 REMEDYREPACK INC. FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 70518-0701_5b37ad88-ff4a-4d29-e053-2991aa0aed65 70518-0701 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20170818 ANDA ANDA076164 REMEDYREPACK INC. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0702_575dfe71-9998-8d50-e053-2a91aa0a93c9 70518-0702 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20170818 ANDA ANDA075520 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70518-0703_574f81fc-3cfb-8b2a-e053-2991aa0a8c20 70518-0703 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170818 ANDA ANDA077118 REMEDYREPACK INC. METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0704_574970ca-d03c-76d8-e053-2991aa0ac146 70518-0704 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20170821 ANDA ANDA040245 REMEDYREPACK INC. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20181231 70518-0705_57495d67-18af-fe33-e053-2a91aa0a101f 70518-0705 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Extended Release Oxybutynin Chloride TABLET, EXTENDED RELEASE ORAL 20170821 ANDA ANDA206121 REMEDYREPACK INC. OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 70518-0706_5cccc071-9a90-2995-e053-2991aa0a7f9a 70518-0706 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20170821 ANDA ANDA078296 REMEDYREPACK INC. LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0707_575dd4bf-72e6-371e-e053-2991aa0a2f2a 70518-0707 HUMAN PRESCRIPTION DRUG pravastatin sodium pravastatin sodium TABLET ORAL 20170822 ANDA ANDA077751 REMEDYREPACK INC. PRAVASTATIN SODIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0708_575dd4bf-72b7-371e-e053-2991aa0a2f2a 70518-0708 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20170822 ANDA ANDA075520 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70518-0709_575dd4bf-7258-371e-e053-2991aa0a2f2a 70518-0709 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20170822 ANDA ANDA076890 REMEDYREPACK INC. LEVOFLOXACIN 750 mg/1 N 20181231 70518-0710_5777da7f-9757-3a3a-e053-2a91aa0a4264 70518-0710 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20170823 ANDA ANDA207582 REMEDYREPACK INC. PERPHENAZINE 4 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0711_5da86e0b-c520-3343-e053-2a91aa0aa8f2 70518-0711 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine TABLET SUBLINGUAL 20170824 ANDA ANDA201760 REMEDYREPACK INC. BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20181231 70518-0712_5c67e199-7ff0-da16-e053-2a91aa0ac052 70518-0712 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20170825 ANDA ANDA065211 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0713_57d659cd-768d-7b3e-e053-2991aa0a162d 70518-0713 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20170825 ANDA ANDA065218 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 600 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0714_57d659cd-7602-7b3e-e053-2991aa0a162d 70518-0714 HUMAN PRESCRIPTION DRUG PREZCOBIX DARUNAVIR ETHANOLATE and COBICISTAT TABLET, FILM COATED ORAL 20170828 NDA NDA205395 REMEDYREPACK INC. DARUNAVIR ETHANOLATE; COBICISTAT 800; 150 mg/1; mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] N 20181231 70518-0715_57d5fa8d-359a-9e2c-e053-2a91aa0a0b23 70518-0715 HUMAN PRESCRIPTION DRUG Abacavir and Lamivudine Abacavir and Lamivudine TABLET, FILM COATED ORAL 20170828 ANDA ANDA204990 REMEDYREPACK INC. ABACAVIR SULFATE; LAMIVUDINE 600; 300 mg/1; mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0716_5811d3b1-4edf-ff75-e053-2991aa0afbf8 70518-0716 HUMAN PRESCRIPTION DRUG Duloxetine Hydrochloride Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20170829 ANDA ANDA202045 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0717_58123f3e-2bc4-c6e0-e053-2991aa0a0aa7 70518-0717 HUMAN PRESCRIPTION DRUG Clopidogrel bisulfate Clopidogrel bisulfate TABLET, FILM COATED ORAL 20170829 ANDA ANDA076273 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 70518-0718_581238b5-0f67-1ffa-e053-2991aa0a3c15 70518-0718 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20170830 ANDA ANDA090083 REMEDYREPACK INC. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0719_581238b5-0f9a-1ffa-e053-2991aa0a3c15 70518-0719 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20170830 ANDA ANDA202801 REMEDYREPACK INC. LEVOFLOXACIN 250 mg/1 N 20181231 70518-0720_5812838a-3f00-4b66-e053-2991aa0a3b8c 70518-0720 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20170831 ANDA ANDA090168 REMEDYREPACK INC. BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 70518-0721_5812838a-3f0f-4b66-e053-2991aa0a3b8c 70518-0721 HUMAN PRESCRIPTION DRUG Betamethasone Valerate betamethasone valerate CREAM TOPICAL 20170831 NDA NDA018861 REMEDYREPACK INC. BETAMETHASONE VALERATE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0722_581238b5-0ffc-1ffa-e053-2991aa0a3c15 70518-0722 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20170831 UNAPPROVED DRUG OTHER REMEDYREPACK INC. PHENOBARBITAL 97.2 mg/1 CIV N 20181231 70518-0723_5812a533-9085-6e6d-e053-2a91aa0afc0c 70518-0723 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20170831 ANDA ANDA202674 REMEDYREPACK INC. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0724_5876cd01-6727-6e4e-e053-2a91aa0abb55 70518-0724 HUMAN PRESCRIPTION DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20170905 ANDA ANDA078432 REMEDYREPACK INC. NAPROXEN SODIUM 550 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0725_5876e61c-12d5-2313-e053-2a91aa0ab75a 70518-0725 HUMAN PRESCRIPTION DRUG REYATAZ ATAZANAVIR CAPSULE, GELATIN COATED ORAL 20170905 NDA NDA021567 REMEDYREPACK INC. ATAZANAVIR SULFATE 200 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 70518-0726_589f12ed-f707-c819-e053-2a91aa0acd82 70518-0726 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20170907 ANDA ANDA076071 REMEDYREPACK INC. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0727_58f1db3d-9255-6bdc-e053-2a91aa0a4e73 70518-0727 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20170911 ANDA ANDA040616 REMEDYREPACK INC. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70518-0728_58f21099-cf98-2e15-e053-2991aa0a6b80 70518-0728 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20170911 ANDA ANDA070278 REMEDYREPACK INC. HALOPERIDOL 2 mg/1 Typical Antipsychotic [EPC] N 20181231 70518-0729_5e98f9e6-714f-63a4-e053-2991aa0a8cb7 70518-0729 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20170911 ANDA ANDA040627 REMEDYREPACK INC. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 70518-0730_58f2610b-8791-dbd5-e053-2991aa0afa68 70518-0730 HUMAN PRESCRIPTION DRUG valproic acid valproic acid CAPSULE ORAL 20170911 ANDA ANDA073229 REMEDYREPACK INC. VALPROIC ACID 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 70518-0731_5903a773-7f07-3223-e053-2991aa0ac983 70518-0731 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20170912 ANDA ANDA207582 REMEDYREPACK INC. PERPHENAZINE 16 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0732_5a983881-1a29-fe23-e053-2a91aa0a12dc 70518-0732 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20170912 ANDA ANDA065061 REMEDYREPACK INC. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 70518-0733_628ab4ea-262b-738f-e053-2a91aa0a61a7 70518-0733 HUMAN PRESCRIPTION DRUG adenosine adenosine INJECTION INTRAVENOUS 20170914 ANDA ANDA077283 REMEDYREPACK INC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20191231 70518-0734_592b8f2b-9951-95b6-e053-2991aa0a4a65 70518-0734 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20170914 ANDA ANDA065507 REMEDYREPACK INC. AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0735_628ab4ea-2608-738f-e053-2a91aa0a61a7 70518-0735 HUMAN PRESCRIPTION DRUG adenosine adenosine INJECTION INTRAVENOUS 20170914 ANDA ANDA077283 REMEDYREPACK INC. ADENOSINE 3 mg/mL Adenosine Receptor Agonist [EPC],Adenosine Receptor Agonists [MoA] N 20191231 70518-0736_638c16fe-8d93-21b4-e053-2991aa0a47a0 70518-0736 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20170914 ANDA ANDA065398 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20191231 70518-0737_5c7d6e1d-d83b-533d-e053-2a91aa0a3cca 70518-0737 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20170918 ANDA ANDA202557 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20181231 70518-0739_5990cbba-b489-3b0a-e053-2991aa0a17be 70518-0739 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20170919 ANDA ANDA077584 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0740_5990c4e0-364b-24d3-e053-2991aa0a4d67 70518-0740 HUMAN PRESCRIPTION DRUG CHLORTHALIDONE CHLORTHALIDONE TABLET ORAL 20170919 ANDA ANDA206904 REMEDYREPACK INC. CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 70518-0741_59b8c6cb-64ba-92a5-e053-2a91aa0a56a1 70518-0741 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20170919 ANDA ANDA075520 REMEDYREPACK INC. NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70518-0742_59a513b0-8f58-2fa6-e053-2991aa0a2b65 70518-0742 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170920 ANDA ANDA090174 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0743_59a513b0-8f07-2fa6-e053-2991aa0a2b65 70518-0743 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20170920 ANDA ANDA204375 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0744_59b8c6cb-6495-92a5-e053-2a91aa0a56a1 70518-0744 HUMAN PRESCRIPTION DRUG Tropicamide Tropicamide SOLUTION/ DROPS OPHTHALMIC 20170920 ANDA ANDA040315 REMEDYREPACK INC. TROPICAMIDE 10 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70518-0745_5c67e199-7fcb-da16-e053-2a91aa0ac052 70518-0745 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20170922 NDA NDA018569 REMEDYREPACK INC. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70518-0746_5a09c199-939a-0a42-e053-2991aa0a91ee 70518-0746 HUMAN OTC DRUG Fexofenadine Hydrochloride fexofenadine TABLET, FILM COATED ORAL 20170925 ANDA ANDA077081 REMEDYREPACK INC. FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 70518-0747_5a1d0e90-0a68-2422-e053-2991aa0a6091 70518-0747 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170925 ANDA ANDA201071 REMEDYREPACK INC. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70518-0748_63291c22-b6c6-0395-e053-2a91aa0a2955 70518-0748 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20170926 ANDA ANDA065271 REMEDYREPACK INC. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 70518-0750_5a462797-3ce1-c2fe-e053-2991aa0a0791 70518-0750 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel bisulphate TABLET, FILM COATED ORAL 20170927 ANDA ANDA202925 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 70518-0751_5a46464f-fd86-c078-e053-2a91aa0a8286 70518-0751 HUMAN PRESCRIPTION DRUG Ethambutol Hydrochloride Ethambutol Hydrochloride TABLET, FILM COATED ORAL 20170927 ANDA ANDA076057 REMEDYREPACK INC. ETHAMBUTOL HYDROCHLORIDE 400 mg/1 Antimycobacterial [EPC] N 20181231 70518-0752_5a59ae2a-523b-6be8-e053-2a91aa0af992 70518-0752 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20170929 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0753_5a59766d-cf96-8fc4-e053-2991aa0a875b 70518-0753 HUMAN PRESCRIPTION DRUG quetiapine fumarate quetiapine fumarate TABLET, FILM COATED ORAL 20170929 ANDA ANDA090960 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0754_5a98397e-f4b9-c0bb-e053-2991aa0a9674 70518-0754 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20171002 ANDA ANDA075576 REMEDYREPACK INC. OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0755_5a97f2c7-7e4a-7a7d-e053-2991aa0ab96b 70518-0755 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20171002 ANDA ANDA040230 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70518-0756_5ac14a16-5b6d-de47-e053-2991aa0a18f8 70518-0756 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20171004 ANDA ANDA075185 REMEDYREPACK INC. DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0757_5ac31997-6296-467b-e053-2a91aa0af3c3 70518-0757 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20171004 ANDA ANDA204375 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0758_5ad21860-f852-4625-e053-2991aa0a9433 70518-0758 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20171005 ANDA ANDA202389 REMEDYREPACK INC. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0759_5ad29b79-2ab7-02a1-e053-2991aa0aced6 70518-0759 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20171005 ANDA ANDA203908 REMEDYREPACK INC. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0760_5ad3d1fd-43ef-3977-e053-2a91aa0a18dd 70518-0760 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20171005 ANDA ANDA076958 REMEDYREPACK INC. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0761_5b272410-142a-6fc3-e053-2a91aa0a9389 70518-0761 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20171006 ANDA ANDA091625 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0763_5ae6fba5-3aa8-6716-e053-2991aa0a5d09 70518-0763 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS AURICULAR (OTIC) 20171006 ANDA ANDA064053 REMEDYREPACK INC. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0764_5ae6fba5-3a75-6716-e053-2991aa0a5d09 70518-0764 HUMAN PRESCRIPTION DRUG OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE ORAL 20171006 ANDA ANDA208578 REMEDYREPACK INC. OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 70518-0765_5ae7480d-2b6b-5564-e053-2a91aa0a0464 70518-0765 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20171006 ANDA ANDA205064 REMEDYREPACK INC. ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0766_5b2577c8-850c-7ff8-e053-2991aa0a5d12 70518-0766 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20171009 ANDA ANDA075743 REMEDYREPACK INC. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70518-0767_5b24a25e-c91d-68b1-e053-2a91aa0a5e90 70518-0767 HUMAN PRESCRIPTION DRUG Quetiapine fumarate Quetiapine fumarate TABLET, FILM COATED ORAL 20171009 ANDA ANDA201190 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0768_5b2577c8-8463-7ff8-e053-2991aa0a5d12 70518-0768 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 20171009 ANDA ANDA040185 REMEDYREPACK INC. PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0769_5b2577c8-8490-7ff8-e053-2991aa0a5d12 70518-0769 HUMAN PRESCRIPTION DRUG Fluoxetine Hydrochloride Fluoxetine Hydrochloride CAPSULE ORAL 20171009 ANDA ANDA075049 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0770_5bc422e7-6942-2317-e053-2a91aa0a095a 70518-0770 HUMAN PRESCRIPTION DRUG Thioridazine Hydrochloride thioridazine hydrochloride TABLET, FILM COATED ORAL 20171009 ANDA ANDA088004 REMEDYREPACK INC. THIORIDAZINE HYDROCHLORIDE 50 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0771_5b2577c8-84f3-7ff8-e053-2991aa0a5d12 70518-0771 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20171009 ANDA ANDA204770 REMEDYREPACK INC. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 70518-0772_5b25f8d5-01a8-93f1-e053-2a91aa0af70a 70518-0772 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20171009 ANDA ANDA202127 REMEDYREPACK INC. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 70518-0773_5b25f8d5-01cd-93f1-e053-2a91aa0af70a 70518-0773 HUMAN PRESCRIPTION DRUG Sevelamer Carbonate Sevelamer Carbonate TABLET, FILM COATED ORAL 20171009 ANDA ANDA207179 REMEDYREPACK INC. SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 70518-0774_5da81d40-d1f6-4a66-e053-2a91aa0a8ddd 70518-0774 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20171010 ANDA ANDA076533 REMEDYREPACK INC. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70518-0775_5c3e709e-224a-1a66-e053-2a91aa0a8dba 70518-0775 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20171010 ANDA ANDA070848 REMEDYREPACK INC. SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 70518-0776_5b372385-d288-725e-e053-2a91aa0a3a29 70518-0776 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol lactate INJECTION INTRAMUSCULAR 20171010 ANDA ANDA075858 REMEDYREPACK INC. HALOPERIDOL LACTATE 5 mg/mL Typical Antipsychotic [EPC] N 20181231 70518-0777_5b36f2ed-afac-2c3c-e053-2991aa0abb15 70518-0777 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20171010 ANDA ANDA077946 REMEDYREPACK INC. CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 70518-0778_5b3775e2-79e8-c9fe-e053-2a91aa0abe96 70518-0778 HUMAN PRESCRIPTION DRUG PROMETHAZINE HYDROCHLORIDE promethazine hydrochloride TABLET ORAL 20171010 ANDA ANDA040712 REMEDYREPACK INC. PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0779_62d7e2d4-a142-5faf-e053-2a91aa0a8e58 70518-0779 HUMAN OTC DRUG anti diarrheal Loperamide Hydrochloride TABLET, FILM COATED ORAL 20171011 ANDA ANDA075232 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20191231 70518-0780_5c511064-e143-098f-e053-2a91aa0a0f1e 70518-0780 HUMAN OTC DRUG allergy Loratadine TABLET ORAL 20171011 ANDA ANDA076301 REMEDYREPACK INC. LORATADINE 10 mg/1 N 20181231 70518-0781_5b6659fd-2cfb-5a80-e053-2a91aa0a9ac7 70518-0781 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20171011 ANDA ANDA202764 REMEDYREPACK INC. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0782_5b5fd17a-2511-c937-e053-2a91aa0a1391 70518-0782 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20171011 ANDA ANDA204375 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0783_5b5fd906-c614-d0ca-e053-2a91aa0a04d2 70518-0783 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET ORAL 20171011 NDA AUTHORIZED GENERIC NDA018602 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70518-0784_5b5fddb5-b761-ff07-e053-2991aa0aa89a 70518-0784 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20171012 ANDA ANDA065225 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0785_5b5fd906-c5ce-d0ca-e053-2a91aa0a04d2 70518-0785 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride Verapamil Hydrochloride TABLET, FILM COATED ORAL 20171012 ANDA ANDA070995 REMEDYREPACK INC. VERAPAMIL HYDROCHLORIDE 80 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70518-0786_5bc3c224-1554-0f01-e053-2991aa0adcf3 70518-0786 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20171013 ANDA ANDA091617 REMEDYREPACK INC. LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0787_5bc3d8d0-ff4b-6745-e053-2a91aa0a0084 70518-0787 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20171013 ANDA ANDA204375 REMEDYREPACK INC. ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0788_5bc3ac3d-a402-a65b-e053-2991aa0acf27 70518-0788 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride bupropion hydrochloride TABLET, FILM COATED ORAL 20171013 ANDA ANDA075491 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 70518-0789_5bc3dc7c-5edb-4de7-e053-2a91aa0a813b 70518-0789 HUMAN PRESCRIPTION DRUG Losartan potassium losartan potassium TABLET, FILM COATED ORAL 20171013 ANDA ANDA077424 REMEDYREPACK INC. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0790_5bc3dc7c-5f11-4de7-e053-2a91aa0a813b 70518-0790 HUMAN PRESCRIPTION DRUG Guanfacine guanfacine Hydrochloride TABLET ORAL 20171013 ANDA ANDA074796 REMEDYREPACK INC. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70518-0791_5bc441cc-ae63-29cf-e053-2a91aa0a0d62 70518-0791 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20171017 ANDA ANDA090939 REMEDYREPACK INC. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70518-0792_5bc4529a-57ec-710c-e053-2991aa0abb0b 70518-0792 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171017 ANDA ANDA077127 REMEDYREPACK INC. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70518-0793_5bc403c9-f121-60d8-e053-2a91aa0aa656 70518-0793 HUMAN PRESCRIPTION DRUG Guanfacine Hydrochloride Guanfacine TABLET ORAL 20171017 ANDA ANDA075109 REMEDYREPACK INC. GUANFACINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70518-0794_5c3e9b18-30f4-6b61-e053-2a91aa0a4c84 70518-0794 HUMAN OTC DRUG LEADER ANTIFUNGAL TOLNAFTATE TOLNAFTATE CREAM TOPICAL 20171018 OTC MONOGRAPH FINAL part333C REMEDYREPACK INC. TOLNAFTATE 10 mg/g N 20181231 70518-0795_60cc3b2c-11bf-978b-e053-2a91aa0aa356 70518-0795 HUMAN OTC DRUG Anecream Lidocaine 4% CREAM TOPICAL 20171019 OTC MONOGRAPH NOT FINAL part348 REMEDYREPACK INC. LIDOCAINE 4 g/100g N 20181231 70518-0796_5c515c84-cbfa-513e-e053-2991aa0aaaeb 70518-0796 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 20171018 ANDA ANDA072076 REMEDYREPACK INC. NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 70518-0797_5c3e83a0-bcbc-e3d2-e053-2991aa0a46d3 70518-0797 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20171018 ANDA ANDA203458 REMEDYREPACK INC. METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 70518-0798_5c3e9b18-3102-6b61-e053-2a91aa0a4c84 70518-0798 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20171018 ANDA ANDA074556 REMEDYREPACK INC. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 70518-0799_5c529e0a-2222-76e6-e053-2991aa0af952 70518-0799 HUMAN PRESCRIPTION DRUG Nitrofurantoin (monohydrate/macrocrystals) Nitrofurantoin monohydrate/macrocrystals CAPSULE ORAL 20171019 ANDA ANDA207372 REMEDYREPACK INC. NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 70518-0800_5c3e9b18-314e-6b61-e053-2a91aa0a4c84 70518-0800 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20171019 ANDA ANDA083677 REMEDYREPACK INC. PREDNISONE 20 mg/1 N 20181231 70518-0801_5c420075-4256-05ce-e053-2991aa0a7884 70518-0801 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20171020 ANDA ANDA078542 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70518-0802_5c3ef272-bb3e-7c2b-e053-2a91aa0acb3b 70518-0802 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20171020 ANDA ANDA090686 REMEDYREPACK INC. DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 70518-0803_5c3ef272-bb71-7c2b-e053-2a91aa0acb3b 70518-0803 HUMAN PRESCRIPTION DRUG azithromycin monohydrate azithromycin monohydrate TABLET ORAL 20171023 ANDA ANDA065398 REMEDYREPACK INC. AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70518-0804_5c7e7baf-4564-9ae1-e053-2991aa0a7865 70518-0804 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20171026 UNAPPROVED DRUG OTHER REMEDYREPACK INC. PHENOBARBITAL 64.8 mg/1 CIV N 20181231 70518-0805_5c7e7baf-45c7-9ae1-e053-2991aa0a7865 70518-0805 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20171026 ANDA ANDA091576 REMEDYREPACK INC. MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 70518-0806_5c7e7baf-457e-9ae1-e053-2991aa0a7865 70518-0806 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20171026 ANDA ANDA201445 REMEDYREPACK INC. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 70518-0807_5c8ed986-ffbd-49f2-e053-2a91aa0a2ae9 70518-0807 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20171027 ANDA ANDA078250 REMEDYREPACK INC. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0808_5c8ed986-ff6f-49f2-e053-2a91aa0a2ae9 70518-0808 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20171027 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0809_5c8ed986-ff60-49f2-e053-2a91aa0a2ae9 70518-0809 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20171027 NDA NDA018823 REMEDYREPACK INC. FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70518-0810_6366cb91-b96b-31d8-e053-2991aa0ab9e9 70518-0810 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN TABLET, FILM COATED ORAL 20171030 ANDA ANDA203244 REMEDYREPACK INC. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 70518-0811_5cdd8540-6ae0-82d1-e053-2a91aa0a5a3a 70518-0811 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM VAGINAL 20171031 ANDA ANDA074366 REMEDYREPACK INC. MICONAZOLE NITRATE 20 mg/g N 20181231 70518-0812_5d066ba2-3ccf-b3eb-e053-2991aa0aa1b2 70518-0812 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20171101 ANDA ANDA078414 REMEDYREPACK INC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70518-0813_5d0646f6-9bcf-56c1-e053-2991aa0ac332 70518-0813 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20171101 ANDA ANDA205300 REMEDYREPACK INC. ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0815_5d060412-185b-6f49-e053-2991aa0ad476 70518-0815 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, COATED ORAL 20171102 ANDA ANDA091024 REMEDYREPACK INC. ESZOPICLONE 3 mg/1 CIV N 20181231 70518-0816_5d05eb0b-f003-f247-e053-2a91aa0ac63b 70518-0816 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, COATED ORAL 20171102 ANDA ANDA091024 REMEDYREPACK INC. ESZOPICLONE 2 mg/1 CIV N 20181231 70518-0817_5d05eb0b-eff0-f247-e053-2a91aa0ac63b 70518-0817 HUMAN OTC DRUG Visine A Multi-Action Eye Allergy Relief Naphazoline Hydrochloride and Pheniramine Maleate SOLUTION/ DROPS OPHTHALMIC 20171102 NDA NDA020485 REMEDYREPACK INC. NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE .25; 3 mg/mL; mg/mL N 20181231 70518-0818_5d05cd48-0bee-d4a3-e053-2a91aa0a7839 70518-0818 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20171102 ANDA ANDA203695 REMEDYREPACK INC. METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 70518-0819_5d1a54e1-a6a9-9a68-e053-2a91aa0a795e 70518-0819 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine TABLET ORAL 20171103 UNAPPROVED DRUG OTHER REMEDYREPACK INC. PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 70518-0820_5d593590-30f3-4aac-e053-2991aa0acfbf 70518-0820 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET, FILM COATED ORAL 20171106 ANDA ANDA074185 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70518-0821_5d59b6ec-8f07-ab91-e053-2991aa0adadd 70518-0821 HUMAN PRESCRIPTION DRUG Terazosin Hydrochloride Terazosin Hydrochloride CAPSULE ORAL 20171106 ANDA ANDA074823 REMEDYREPACK INC. TERAZOSIN HYDROCHLORIDE 5 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70518-0822_5d593590-310d-4aac-e053-2991aa0acfbf 70518-0822 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20171106 UNAPPROVED DRUG OTHER REMEDYREPACK INC. PHENOBARBITAL 60 mg/1 CIV N 20181231 70518-0825_5d6ae19d-8454-4779-e053-2991aa0a2774 70518-0825 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20171107 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0827_5d957668-6b4f-3b33-e053-2991aa0ac02e 70518-0827 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171108 ANDA ANDA076467 REMEDYREPACK INC. GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0828_61e63c8a-0f4c-e0f1-e053-2a91aa0ac748 70518-0828 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20171108 ANDA ANDA078050 REMEDYREPACK INC. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 70518-0829_6210d572-6254-4445-e053-2991aa0a360d 70518-0829 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20171108 ANDA ANDA090469 REMEDYREPACK INC. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 70518-0830_5d966e42-2085-24ab-e053-2991aa0ab6c8 70518-0830 HUMAN PRESCRIPTION DRUG Thiothixene thiothixene CAPSULE ORAL 20171109 ANDA ANDA071093 REMEDYREPACK INC. THIOTHIXENE 1 mg/1 Typical Antipsychotic [EPC] N 20181231 70518-0831_5d961530-fa6d-492f-e053-2a91aa0a6fee 70518-0831 HUMAN PRESCRIPTION DRUG Haloperidol Haloperidol TABLET ORAL 20171109 ANDA ANDA077580 REMEDYREPACK INC. HALOPERIDOL 20 mg/1 Typical Antipsychotic [EPC] N 20181231 70518-0832_5d96ee49-a0d1-de97-e053-2991aa0ab57d 70518-0832 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20171109 ANDA ANDA086242 REMEDYREPACK INC. HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 70518-0833_5d96ee49-a0aa-de97-e053-2991aa0ab57d 70518-0833 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 20171109 ANDA ANDA070178 REMEDYREPACK INC. PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0834_5d96ee49-a0e6-de97-e053-2991aa0ab57d 70518-0834 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20171109 ANDA ANDA040197 REMEDYREPACK INC. ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 70518-0835_5da80ca3-413f-32be-e053-2a91aa0a55cd 70518-0835 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20171110 ANDA ANDA077073 REMEDYREPACK INC. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70518-0836_61d23fac-023d-7cc5-e053-2991aa0a554d 70518-0836 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20171110 NDA NDA018823 REMEDYREPACK INC. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 70518-0837_5da7f09b-cfed-6e51-e053-2a91aa0a67b3 70518-0837 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE, LIQUID FILLED ORAL 20171110 ANDA ANDA040682 REMEDYREPACK INC. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 70518-0839_5da7aefb-543c-1586-e053-2a91aa0a89e9 70518-0839 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin Mesylate TABLET ORAL 20171110 ANDA ANDA075536 REMEDYREPACK INC. DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70518-0840_5da7b877-daee-d9af-e053-2a91aa0aa7a0 70518-0840 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20171110 ANDA ANDA077614 REMEDYREPACK INC. CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70518-0841_5da7b16f-325a-34eb-e053-2991aa0a7046 70518-0841 HUMAN PRESCRIPTION DRUG Phenytoin Phenytoin TABLET, CHEWABLE ORAL 20171110 ANDA ANDA200565 REMEDYREPACK INC. PHENYTOIN 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20181231 70518-0843_5da75359-dd74-6223-e053-2991aa0a64cc 70518-0843 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 20171110 ANDA ANDA088238 REMEDYREPACK INC. DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0844_5da9d1ef-5d1a-5f36-e053-2a91aa0a1a6c 70518-0844 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20171110 ANDA ANDA078321 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0845_6288ea9d-bce5-8e11-e053-2991aa0afc2a 70518-0845 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20171113 ANDA ANDA076164 REMEDYREPACK INC. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 70518-0846_5de624c6-511a-0781-e053-2991aa0a7d90 70518-0846 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20171113 ANDA ANDA201043 REMEDYREPACK INC. LEVOFLOXACIN 750 mg/1 N 20181231 70518-0847_5de5c4be-961e-5911-e053-2991aa0a33fe 70518-0847 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20171113 ANDA ANDA071524 REMEDYREPACK INC. TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 70518-0848_5e121e8a-c134-7f86-e053-2a91aa0ac84e 70518-0848 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20171114 NDA AUTHORIZED GENERIC NDA020405 REMEDYREPACK INC. DIGOXIN .25 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 70518-0849_6276a13e-5165-3090-e053-2991aa0a7fef 70518-0849 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20171127 ANDA ANDA205519 REMEDYREPACK INC. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 70518-0850_5e0f1e69-310c-18f8-e053-2a91aa0acd5e 70518-0850 HUMAN PRESCRIPTION DRUG Paliperidone paliperidone TABLET, EXTENDED RELEASE ORAL 20171115 NDA NDA021999 REMEDYREPACK INC. PALIPERIDONE 9 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0851_5e0f0cca-20c5-382d-e053-2991aa0a5b17 70518-0851 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium GEL TOPICAL 20171115 ANDA ANDA200936 REMEDYREPACK INC. DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0852_5e1f8916-05bf-6990-e053-2a91aa0a96da 70518-0852 HUMAN OTC DRUG Pain Reliever Plus Acetaminophen, Aspirin and caffeine TABLET, FILM COATED ORAL 20171116 OTC MONOGRAPH NOT FINAL part343 REMEDYREPACK INC. ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 70518-0853_5e36b814-c097-68c1-e053-2991aa0ac9c1 70518-0853 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20171117 ANDA ANDA090256 REMEDYREPACK INC. FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0855_5e3686bf-bde9-828d-e053-2a91aa0a6a90 70518-0855 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 20171117 ANDA ANDA040911 REMEDYREPACK INC. LIDOCAINE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 70518-0856_61e635d8-91a8-8b49-e053-2a91aa0a2f6b 70518-0856 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 20171117 ANDA ANDA075079 REMEDYREPACK INC. OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 70518-0857_5e34ce06-6a7b-7122-e053-2a91aa0a61bb 70518-0857 HUMAN PRESCRIPTION DRUG Losartan potassium losartan potassium TABLET, FILM COATED ORAL 20171117 ANDA ANDA077424 REMEDYREPACK INC. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0858_5e710c4d-0e92-2d4c-e053-2a91aa0a810a 70518-0858 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 20171120 ANDA ANDA040317 REMEDYREPACK INC. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70518-0859_5f3f684e-2c9a-324a-e053-2a91aa0afcaa 70518-0859 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20171120 ANDA ANDA090693 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 70518-0860_5e70be25-aa61-fafa-e053-2991aa0a32f0 70518-0860 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20171120 ANDA ANDA202038 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 70518-0861_5e995c68-6a70-a787-e053-2a91aa0afe81 70518-0861 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20171122 OTC MONOGRAPH FINAL part336 REMEDYREPACK INC. DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 70518-0862_5e9924be-4d79-324a-e053-2a91aa0a8ec1 70518-0862 HUMAN PRESCRIPTION DRUG Losatan Potassium Losatan Potassium TABLET, FILM COATED ORAL 20171122 ANDA ANDA090428 REMEDYREPACK INC. LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70518-0863_60193597-9ed5-c6c1-e053-2991aa0a9d3c 70518-0863 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20171124 ANDA ANDA090624 REMEDYREPACK INC. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 70518-0864_5ec0e299-23b4-4bef-e053-2991aa0af791 70518-0864 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 20171124 ANDA ANDA064065 REMEDYREPACK INC. HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 70518-0865_5ec0e299-239c-4bef-e053-2991aa0af791 70518-0865 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CREAM TOPICAL 20171124 NDA AUTHORIZED GENERIC NDA020126 REMEDYREPACK INC. DOXEPIN HYDROCHLORIDE 50 mg/g Tricyclic Antidepressant [EPC] N 20181231 70518-0866_5eff9509-2769-6782-e053-2a91aa0a0f2f 70518-0866 HUMAN PRESCRIPTION DRUG FOLIC ACID folic acid TABLET ORAL 20171124 ANDA ANDA204418 REMEDYREPACK INC. FOLIC ACID 1 mg/1 N 20181231 70518-0868_5f001519-d071-4bab-e053-2a91aa0aa46f 70518-0868 HUMAN PRESCRIPTION DRUG Metoprolol metoprolol tartrate INJECTION INTRAVENOUS 20171127 ANDA ANDA078950 REMEDYREPACK INC. METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0869_5eff9509-2795-6782-e053-2a91aa0a0f2f 70518-0869 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride INJECTION INTRAVENOUS 20171127 ANDA ANDA078538 REMEDYREPACK INC. DILTIAZEM HYDROCHLORIDE 5 mg/mL Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70518-0870_5eff783b-10cf-4d29-e053-2a91aa0a0999 70518-0870 HUMAN PRESCRIPTION DRUG Quelicin Succinylcholine Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171127 NDA NDA008845 REMEDYREPACK INC. SUCCINYLCHOLINE CHLORIDE 20 mg/mL Depolarizing Neuromuscular Blocker [EPC],Neuromuscular Depolarizing Blockade [PE] N 20181231 70518-0871_5efdf9f2-009a-1c2d-e053-2a91aa0a6501 70518-0871 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac SOLUTION TOPICAL 20171127 ANDA ANDA206116 REMEDYREPACK INC. DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0872_5f11c756-56a0-5c29-e053-2a91aa0a723c 70518-0872 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171128 ANDA ANDA084916 REMEDYREPACK INC. DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0873_5f2bf38f-73db-e0f7-e053-2a91aa0a178f 70518-0873 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20171129 ANDA ANDA077824 REMEDYREPACK INC. RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70518-0875_5f2b7afc-a3e7-763c-e053-2991aa0ad839 70518-0875 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20171129 ANDA ANDA071251 REMEDYREPACK INC. TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70518-0876_616d73b6-8707-af5f-e053-2991aa0ad70f 70518-0876 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20171129 ANDA ANDA076341 REMEDYREPACK INC. PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0877_5f2b7afc-a2d2-763c-e053-2991aa0ad839 70518-0877 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20171129 ANDA ANDA076704 REMEDYREPACK INC. METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0878_5f2b7afc-a347-763c-e053-2991aa0ad839 70518-0878 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20171129 ANDA ANDA091624 REMEDYREPACK INC. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70518-0879_5f3f6197-8622-5170-e053-2991aa0a2534 70518-0879 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20171130 ANDA ANDA204216 REMEDYREPACK INC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 70518-0880_5f8b0592-f770-4a8c-e053-2a91aa0a2de2 70518-0880 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate SPRAY, METERED NASAL 20171130 ANDA ANDA076504 REMEDYREPACK INC. FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70518-0881_5f3f152f-efb2-6a35-e053-2991aa0a93c7 70518-0881 HUMAN PRESCRIPTION DRUG Benztropine Mesylate benztropine mesylate TABLET ORAL 20171130 ANDA ANDA204713 REMEDYREPACK INC. BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 70518-0882_5f3f4334-b165-0c83-e053-2991aa0a8442 70518-0882 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20171130 ANDA ANDA074056 REMEDYREPACK INC. ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70518-0883_5f3f152f-f00a-6a35-e053-2991aa0a93c7 70518-0883 HUMAN PRESCRIPTION DRUG Hydroxyzine Pamoate Hydroxyzine Pamoate CAPSULE ORAL 20171130 ANDA ANDA040156 REMEDYREPACK INC. HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 70518-0884_5f3f152f-efc8-6a35-e053-2991aa0a93c7 70518-0884 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20171130 ANDA ANDA206383 REMEDYREPACK INC. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0886_5f8a422a-3d43-d84a-e053-2a91aa0a4a24 70518-0886 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20171204 ANDA ANDA200503 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 70518-0887_5f907271-bc30-0083-e053-2a91aa0a09d8 70518-0887 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20171204 ANDA ANDA090278 REMEDYREPACK INC. TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0888_5f9e4cba-3ec3-54b4-e053-2a91aa0a6e7c 70518-0888 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20171205 ANDA ANDA091166 REMEDYREPACK INC. ESZOPICLONE 3 mg/1 CIV N 20181231 70518-0889_5fc68f04-ec18-11c0-e053-2a91aa0a1952 70518-0889 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20171207 ANDA ANDA202152 REMEDYREPACK INC. QUETIAPINE FUMARATE 25 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0890_5fdaa495-cac4-ffce-e053-2991aa0a0b75 70518-0890 HUMAN PRESCRIPTION DRUG Potassium Chloride potassium chloride TABLET, EXTENDED RELEASE ORAL 20171208 ANDA ANDA076368 REMEDYREPACK INC. POTASSIUM CHLORIDE 20 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 70518-0891_647dadae-f32e-8399-e053-2991aa0aedb3 70518-0891 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20171212 ANDA ANDA075964 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20191231 70518-0892_602c50fc-7761-745e-e053-2a91aa0afa39 70518-0892 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20171212 ANDA ANDA077851 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 70518-0893_602bc903-1ae7-bc59-e053-2a91aa0a767c 70518-0893 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20171212 ANDA ANDA072741 REMEDYREPACK INC. LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] N 20181231 70518-0894_602bccf1-4061-c08f-e053-2991aa0a3a3e 70518-0894 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20171212 ANDA ANDA078069 REMEDYREPACK INC. OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70518-0895_625f253d-c6fc-913e-e053-2a91aa0a3758 70518-0895 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20171212 ANDA ANDA065271 REMEDYREPACK INC. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 70518-0896_602ca10d-488e-c90c-e053-2991aa0a3850 70518-0896 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20171212 ANDA ANDA204838 REMEDYREPACK INC. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0897_602cb0ae-4309-7ac2-e053-2a91aa0a60b6 70518-0897 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20171212 ANDA ANDA090693 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 70518-0898_6043d837-2c53-674a-e053-2a91aa0a05fd 70518-0898 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20171212 ANDA ANDA070974 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70518-0899_60444c9e-2963-bb42-e053-2a91aa0a40f1 70518-0899 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE EXTENDED RELEASE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20171212 ANDA ANDA090295 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0900_6044c441-bd97-09af-e053-2a91aa0a1dfe 70518-0900 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20171212 ANDA ANDA090693 REMEDYREPACK INC. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 70518-0901_6041d900-97e3-f2b5-e053-2a91aa0ae080 70518-0901 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20171212 ANDA ANDA076119 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 N 20181231 70518-0902_6041c81e-60b2-ee79-e053-2a91aa0af9ab 70518-0902 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20171212 ANDA ANDA077272 REMEDYREPACK INC. CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 70518-0903_604157f5-f843-4a01-e053-2991aa0a18bf 70518-0903 HUMAN PRESCRIPTION DRUG REMERON MIRTAZAPINE TABLET, FILM COATED ORAL 20171212 NDA NDA020415 REMEDYREPACK INC. MIRTAZAPINE 15 mg/1 N 20181231 70518-0904_60412a47-d2e2-7cc0-e053-2991aa0a35bf 70518-0904 HUMAN PRESCRIPTION DRUG Lithium Carbonate lithium carbonate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171212 ANDA ANDA202288 REMEDYREPACK INC. LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20181231 70518-0905_6040df93-29f2-30fc-e053-2a91aa0a5c88 70518-0905 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20171212 ANDA ANDA075757 REMEDYREPACK INC. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70518-0907_6040571a-9319-af86-e053-2991aa0a39e6 70518-0907 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20171213 ANDA ANDA077911 REMEDYREPACK INC. GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70518-0908_6159e6e0-6c21-3e90-e053-2a91aa0a72cb 70518-0908 HUMAN PRESCRIPTION DRUG Glipizide and Metformin Hydrochloride Glipizide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20171213 ANDA ANDA078905 REMEDYREPACK INC. GLIPIZIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70518-0909_6053d479-9d68-0ae9-e053-2991aa0a5dd1 70518-0909 HUMAN PRESCRIPTION DRUG Sevelamer carbonate SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20171214 ANDA ANDA203860 REMEDYREPACK INC. SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 70518-0911_6053abc4-06a9-5dcd-e053-2991aa0ac318 70518-0911 HUMAN PRESCRIPTION DRUG Phenobarbital phenobarbital TABLET ORAL 20171214 UNAPPROVED DRUG OTHER REMEDYREPACK INC. PHENOBARBITAL 16.2 mg/1 CIV N 20181231 70518-0912_606775e1-5599-a155-e053-2991aa0a8dec 70518-0912 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20171215 ANDA ANDA065248 REMEDYREPACK INC. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 70518-0913_60cb962b-0e31-105a-e053-2a91aa0a040e 70518-0913 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20171220 NDA AUTHORIZED GENERIC NDA020405 REMEDYREPACK INC. DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 70518-0914_60cc11ec-9f88-5aad-e053-2a91aa0a8914 70518-0914 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20171220 ANDA ANDA077863 REMEDYREPACK INC. DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70518-0915_60cbed13-cdce-5ac6-e053-2991aa0ada08 70518-0915 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 20171220 ANDA ANDA075319 REMEDYREPACK INC. KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70518-0916_60cd209b-49f5-4fd9-e053-2a91aa0a4c7d 70518-0916 HUMAN PRESCRIPTION DRUG Hydroxyurea Hydroxyurea CAPSULE ORAL 20171220 ANDA ANDA075340 REMEDYREPACK INC. HYDROXYUREA 500 mg/1 Antimetabolite [EPC],Urea [Chemical/Ingredient] N 20181231 70518-0917_60e06d1c-7058-2b2e-e053-2991aa0a4ecb 70518-0917 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20171221 ANDA ANDA207582 REMEDYREPACK INC. PERPHENAZINE 8 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 70518-0918_60e06d1c-7085-2b2e-e053-2991aa0a4ecb 70518-0918 HUMAN PRESCRIPTION DRUG Tenofovir Disoproxil Fumarate Tenofovir Disoproxil Fumarate TABLET, FILM COATED ORAL 20171221 ANDA ANDA091612 REMEDYREPACK INC. TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70518-0919_60e0636f-1aab-a4d5-e053-2a91aa0ae3fe 70518-0919 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20171221 ANDA ANDA085762 REMEDYREPACK INC. DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV N 20181231 70518-0920_6144f181-745b-51df-e053-2991aa0aef62 70518-0920 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 20171222 ANDA ANDA040197 REMEDYREPACK INC. ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 70518-0921_614560f9-9ca6-f46f-e053-2991aa0a9c23 70518-0921 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20171226 ANDA ANDA202862 REMEDYREPACK INC. OLANZAPINE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 70518-0922_615a0c9a-bb6f-5cc0-e053-2a91aa0a9385 70518-0922 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20171226 ANDA ANDA202330 REMEDYREPACK INC. BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 70518-0923_616ddc6b-7292-bcaf-e053-2a91aa0a5702 70518-0923 HUMAN OTC DRUG HEALTH SENSE ASPIRIN 81 Aspirin TABLET, COATED ORAL 20171228 OTC MONOGRAPH FINAL part343 REMEDYREPACK INC. ASPIRIN 81 mg/1 N 20181231 70518-0925_6181887b-a0d5-6d93-e053-2991aa0a14e2 70518-0925 HUMAN PRESCRIPTION DRUG VALSARTAN AND HYDROCHLOROTHIAZIDE valsartan and hydrochlorothiazide TABLET, FILM COATED ORAL 20171229 ANDA ANDA206083 REMEDYREPACK INC. VALSARTAN; HYDROCHLOROTHIAZIDE 320; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 70518-0926_61e3270e-8e35-7cb3-e053-2991aa0a5f45 70518-0926 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine PATCH TOPICAL 20180103 ANDA ANDA200675 REMEDYREPACK INC. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 70518-0927_61f9f9d9-056d-24a8-e053-2991aa0a2bcf 70518-0927 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20180104 ANDA ANDA090564 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 70518-0929_63296cc5-9eb9-ede9-e053-2991aa0a3cb7 70518-0929 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20180104 ANDA ANDA065271 REMEDYREPACK INC. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 70518-0930_62109330-81b4-e5af-e053-2a91aa0a031d 70518-0930 HUMAN PRESCRIPTION DRUG benzonatate benzonatate CAPSULE ORAL 20180105 ANDA ANDA040627 REMEDYREPACK INC. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 70518-0931_621060f6-e144-c797-e053-2a91aa0add41 70518-0931 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20180105 ANDA ANDA091264 REMEDYREPACK INC. LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 70518-0932_621060f6-e0de-c797-e053-2a91aa0add41 70518-0932 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20180105 ANDA ANDA076710 REMEDYREPACK INC. LEVOFLOXACIN 750 mg/1 N 20191231 70518-0933_620fa9c8-fd7d-7a96-e053-2991aa0a7c34 70518-0933 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20180105 ANDA ANDA079171 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 70518-0934_620f5d9e-f30e-8e5a-e053-2991aa0a7fff 70518-0934 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20180105 ANDA ANDA078671 REMEDYREPACK INC. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 70518-0935_6213af67-2e34-5e56-e053-2a91aa0a414a 70518-0935 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20180105 ANDA ANDA202862 REMEDYREPACK INC. OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20191231 70518-0936_6213dafa-c073-3366-e053-2991aa0abfb7 70518-0936 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20180105 ANDA ANDA077987 REMEDYREPACK INC. PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 70518-0937_6213af67-2dd2-5e56-e053-2a91aa0a414a 70518-0937 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20180105 ANDA ANDA090778 REMEDYREPACK INC. DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 70518-0938_6213dafa-c030-3366-e053-2991aa0abfb7 70518-0938 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20180105 ANDA ANDA077670 REMEDYREPACK INC. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 70518-0939_6213dafa-bfe2-3366-e053-2991aa0abfb7 70518-0939 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20180105 ANDA ANDA077987 REMEDYREPACK INC. PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 70518-0940_624c4dc4-4502-4970-e053-2a91aa0a6d93 70518-0940 HUMAN PRESCRIPTION DRUG Perphenazine Perphenazine TABLET, FILM COATED ORAL 20180108 ANDA ANDA207582 REMEDYREPACK INC. PERPHENAZINE 2 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 70518-0942_625e8ccf-67b8-0bf9-e053-2a91aa0a5870 70518-0942 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20180109 ANDA ANDA200503 REMEDYREPACK INC. TRAMADOL HYDROCHLORIDE 100 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20191231 70518-0943_625e8ccf-674e-0bf9-e053-2a91aa0a5870 70518-0943 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20180109 ANDA ANDA078106 REMEDYREPACK INC. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 70518-0945_6272b046-9b73-0ac7-e053-2a91aa0a8f9a 70518-0945 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir phosphate CAPSULE ORAL 20180110 ANDA ANDA202595 REMEDYREPACK INC. OSELTAMIVIR PHOSPHATE 75 mg/1 N 20191231 70518-0946_62727d79-c39c-3e84-e053-2a91aa0a45f1 70518-0946 HUMAN PRESCRIPTION DRUG Atazanavir Sulfate Atazanavir Sulfate CAPSULE ORAL 20180110 ANDA ANDA091673 REMEDYREPACK INC. ATAZANAVIR SULFATE 300 mg/1 HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20191231 70518-0947_6272aa69-9501-0a28-e053-2a91aa0a22cc 70518-0947 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20180110 ANDA ANDA090515 REMEDYREPACK INC. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 70518-0948_6272b046-9bb3-0ac7-e053-2a91aa0a8f9a 70518-0948 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20180110 ANDA ANDA040362 REMEDYREPACK INC. PREDNISONE 20 mg/1 N 20191231 70518-0950_6286e9f4-fd74-7a02-e053-2991aa0a3ef6 70518-0950 HUMAN PRESCRIPTION DRUG Magnesium Sulfate MAGNESIUM SULFATE HEPTAHYDRATE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20180111 NDA NDA019316 REMEDYREPACK INC. MAGNESIUM SULFATE HEPTAHYDRATE 500 mg/mL Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 70518-0951_628721e9-283f-7698-e053-2a91aa0a1a6c 70518-0951 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20180111 NDA NDA205029 REMEDYREPACK INC. EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20191231 70518-0952_6286e5ca-7c70-1ed4-e053-2a91aa0aec43 70518-0952 HUMAN PRESCRIPTION DRUG FUROSEMIDE furosemide INJECTION, SOLUTION INTRAVENOUS 20180111 ANDA ANDA202747 REMEDYREPACK INC. FUROSEMIDE 10 mg/mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 70518-0953_629b333e-843a-0753-e053-2991aa0a1dd2 70518-0953 HUMAN PRESCRIPTION DRUG Viagra sildenafil citrate TABLET, FILM COATED ORAL 20180112 NDA NDA020895 REMEDYREPACK INC. SILDENAFIL CITRATE 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 70518-0954_629b168d-cb25-0d97-e053-2a91aa0a5f95 70518-0954 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20180112 ANDA ANDA078103 REMEDYREPACK INC. SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 70518-0955_62d6dbe9-6ace-fe23-e053-2a91aa0a4baf 70518-0955 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION INTRAVENOUS 20180112 ANDA ANDA203449 REMEDYREPACK INC. SODIUM BICARBONATE 84 mg/mL N 20191231 70518-0956_629b06c5-67e5-3cea-e053-2991aa0a37db 70518-0956 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron INJECTION INTRAMUSCULAR; INTRAVENOUS 20180112 ANDA ANDA077541 REMEDYREPACK INC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 70518-0957_637c0160-065c-8934-e053-2a91aa0af34a 70518-0957 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20180112 ANDA ANDA065248 REMEDYREPACK INC. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 70518-0958_62d6dbe9-6a34-fe23-e053-2a91aa0a4baf 70518-0958 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20180115 ANDA ANDA205528 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 70518-0959_62d9ae6c-ac95-1f0e-e053-2a91aa0a52b0 70518-0959 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20180115 ANDA ANDA090083 REMEDYREPACK INC. LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 70518-0960_62d941be-0f33-980c-e053-2a91aa0a624a 70518-0960 HUMAN PRESCRIPTION DRUG Nifedipine nifedipine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20180115 ANDA ANDA090649 REMEDYREPACK INC. NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 70518-0962_62fffc99-7621-4360-e053-2a91aa0a5e75 70518-0962 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20180117 ANDA ANDA078281 REMEDYREPACK INC. PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 70518-0963_63000f30-1bec-4ae9-e053-2a91aa0a72f1 70518-0963 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20180117 ANDA ANDA079171 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 70518-0964_62fffc99-753f-4360-e053-2a91aa0a5e75 70518-0964 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20180117 ANDA ANDA075356 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE ANHYDROUS 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 70518-0965_63138e4a-bc94-48d8-e053-2a91aa0aaf20 70518-0965 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20180118 ANDA ANDA076644 REMEDYREPACK INC. OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20191231 70518-0966_63139afe-50e6-ae4a-e053-2991aa0a48f0 70518-0966 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20180118 ANDA ANDA074174 REMEDYREPACK INC. ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 70518-0967_63279283-3646-f0ef-e053-2991aa0a4a3a 70518-0967 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20180119 ANDA ANDA076710 REMEDYREPACK INC. LEVOFLOXACIN 250 mg/1 N 20191231 70518-0968_6364d12e-03db-ff65-e053-2a91aa0a7fb3 70518-0968 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20180122 ANDA ANDA202801 REMEDYREPACK INC. LEVOFLOXACIN 750 mg/1 N 20191231 70518-0969_6378a96b-56ad-2889-e053-2991aa0a6b7a 70518-0969 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20180122 ANDA ANDA075682 REMEDYREPACK INC. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 70518-0970_637851c6-ff74-8bbc-e053-2991aa0a963c 70518-0970 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20180122 ANDA ANDA204838 REMEDYREPACK INC. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20191231 70518-0971_63666e3e-992b-be45-e053-2a91aa0a3dc0 70518-0971 HUMAN PRESCRIPTION DRUG Fluoxetine fluoxetine TABLET, FILM COATED ORAL 20180122 ANDA ANDA075755 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 70518-0972_63666e3e-9895-be45-e053-2a91aa0a3dc0 70518-0972 HUMAN PRESCRIPTION DRUG Escitalopram Oxalate escitalopram TABLET, FILM COATED ORAL 20180122 NDA NDA021323 REMEDYREPACK INC. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 70518-0973_63786902-3ed2-e847-e053-2991aa0a0463 70518-0973 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20180122 ANDA ANDA203755 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 70518-0974_63663257-5b66-5b57-e053-2a91aa0ae4b6 70518-0974 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20180122 ANDA ANDA201504 REMEDYREPACK INC. QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] N 20191231 70518-0975_636975d7-6088-9fad-e053-2991aa0a8eec 70518-0975 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET ORAL 20180122 ANDA ANDA201504 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20191231 70518-0976_6364e152-bdb9-526b-e053-2a91aa0a7a01 70518-0976 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20180122 ANDA ANDA204838 REMEDYREPACK INC. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20191231 70518-0977_63663257-5b07-5b57-e053-2a91aa0ae4b6 70518-0977 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20180122 ANDA ANDA076119 REMEDYREPACK INC. MIRTAZAPINE 30 mg/1 N 20191231 70518-0978_63653dca-127f-3462-e053-2a91aa0ae6ce 70518-0978 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20180122 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20191231 70518-0979_63653636-4337-6410-e053-2991aa0a4941 70518-0979 HUMAN PRESCRIPTION DRUG risperidone risperidone TABLET, FILM COATED ORAL 20180122 ANDA ANDA078040 REMEDYREPACK INC. RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] N 20191231 70518-0980_63651522-9c55-2cda-e053-2991aa0ac6da 70518-0980 HUMAN PRESCRIPTION DRUG Dilantin Phenytoin Sodium CAPSULE, EXTENDED RELEASE ORAL 20180122 ANDA ANDA084349 REMEDYREPACK INC. PHENYTOIN SODIUM 30 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20191231 70518-0981_6364bb4a-2a1c-c230-e053-2991aa0a6540 70518-0981 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20180122 ANDA ANDA040621 REMEDYREPACK INC. PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20191231 70518-0982_6364d12e-0471-ff65-e053-2a91aa0a7fb3 70518-0982 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20180122 ANDA ANDA200834 REMEDYREPACK INC. VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 70518-0983_6364d12e-0389-ff65-e053-2a91aa0a7fb3 70518-0983 HUMAN OTC DRUG Pain and Fever ACETAMINOPHEN TABLET ORAL 20180122 OTC MONOGRAPH NOT FINAL part343 REMEDYREPACK INC. ACETAMINOPHEN 325 mg/1 N 20191231 70518-0984_6364d12e-043b-ff65-e053-2a91aa0a7fb3 70518-0984 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20180122 ANDA ANDA076900 REMEDYREPACK INC. ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 70518-0986_63662ddc-5a6c-4b1e-e053-2a91aa0a8c64 70518-0986 HUMAN PRESCRIPTION DRUG Rosuvastatin Rosuvastatin TABLET, FILM COATED ORAL 20180122 ANDA ANDA207616 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 70518-0987_63b452b3-5a55-d996-e053-2991aa0aa1a2 70518-0987 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20180125 ANDA ANDA079170 REMEDYREPACK INC. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 70518-0989_63a4de60-9c59-0547-e053-2a91aa0a982a 70518-0989 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20180125 ANDA ANDA202674 REMEDYREPACK INC. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20191231 70518-0990_63b452b3-5a96-d996-e053-2991aa0aa1a2 70518-0990 HUMAN PRESCRIPTION DRUG Clopidogrel Bisulfate Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20180125 ANDA ANDA090494 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20191231 70518-0991_63a49b3f-de45-5397-e053-2991aa0a7a06 70518-0991 HUMAN PRESCRIPTION DRUG clopidogrel clopidogrel TABLET, FILM COATED ORAL 20180125 ANDA ANDA204165 REMEDYREPACK INC. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20191231 70518-0992_63b4595a-2c6f-1db8-e053-2991aa0a0d6e 70518-0992 HUMAN OTC DRUG Mi-Acid Gas Relief Simethicone TABLET, CHEWABLE ORAL 20180126 OTC MONOGRAPH FINAL part332 REMEDYREPACK INC. DIMETHICONE 80 mg/1 N 20191231 70518-0993_63f14d1c-3d5f-48df-e053-2a91aa0a7d88 70518-0993 HUMAN PRESCRIPTION DRUG PAROXETINE paroxetine hydrochloride TABLET, FILM COATED ORAL 20180129 ANDA ANDA075356 REMEDYREPACK INC. PAROXETINE HYDROCHLORIDE ANHYDROUS 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 70518-0994_63f16732-d37d-5913-e053-2991aa0aafdc 70518-0994 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20180129 ANDA ANDA075967 REMEDYREPACK INC. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 70518-0995_63f14d1c-3d36-48df-e053-2a91aa0a7d88 70518-0995 HUMAN PRESCRIPTION DRUG Loxapine loxapine CAPSULE ORAL 20180129 ANDA ANDA076762 REMEDYREPACK INC. LOXAPINE SUCCINATE 10 mg/1 N 20191231 70518-0996_64051583-0253-4de8-e053-2a91aa0ae08c 70518-0996 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20180130 ANDA ANDA064076 REMEDYREPACK INC. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 70518-0997_642ce780-d8e4-db8c-e053-2991aa0ab898 70518-0997 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine Hydrochloride CAPSULE ORAL 20180201 ANDA ANDA204597 REMEDYREPACK INC. FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 70518-0998_642f9411-017b-0469-e053-2a91aa0a8899 70518-0998 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20180201 ANDA ANDA074223 REMEDYREPACK INC. GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 70518-1000_64417158-eccc-bbb2-e053-2991aa0a3126 70518-1000 HUMAN PRESCRIPTION DRUG clonidine hydrochloride Clonidine Hydrochloride TABLET ORAL 20180202 ANDA ANDA091368 REMEDYREPACK INC. CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 70518-1001_6441a5fc-b3b8-6220-e053-2a91aa0aef84 70518-1001 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20180202 ANDA ANDA075805 REMEDYREPACK INC. FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 70518-1002_64452b23-5cce-389a-e053-2991aa0a0170 70518-1002 HUMAN PRESCRIPTION DRUG TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate TABLET ORAL 20180202 ANDA ANDA090742 REMEDYREPACK INC. TENOFOVIR DISOPROXIL FUMARATE 300 mg/1 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 70518-1003_6491f76a-592f-639f-e053-2991aa0a1196 70518-1003 HUMAN PRESCRIPTION DRUG Etomidate etomidate INJECTION, SOLUTION INTRAVENOUS 20180206 ANDA ANDA209058 REMEDYREPACK INC. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20191231 70519-001_5ad27514-9b8c-4526-8426-35cbca2d0a67 70519-001 HUMAN OTC DRUG Prestige Caviar Essential Barrier Eye Cream DIMETHICONE CREAM TOPICAL 20170627 OTC MONOGRAPH FINAL part347 FW1 R&D_Branch DIMETHICONE 1.5 mg/30mL N 20181231 70519-002_e49ee302-13a8-4cf3-a0e0-fa1c6584e782 70519-002 HUMAN OTC DRUG Prestige Caviar Full Intensive Vitality Toner NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170627 UNAPPROVED DRUG OTHER FW1 R&D_Branch NIACINAMIDE; ADENOSINE 2.6; .052 mg/130mL; mg/130mL N 20181231 70519-003_6d89eb4e-9249-4376-ab0a-c2289a6d8387 70519-003 HUMAN OTC DRUG Prestige Caviar Full Moisturizing Emulsion DIMETHICONE EMULSION TOPICAL 20170627 OTC MONOGRAPH FINAL part347 FW1 R&D_Branch DIMETHICONE 2.6 mg/130mL N 20181231 70519-004_9196c80c-2fd3-4dce-928f-905f8edb6937 70519-004 HUMAN OTC DRUG Prestige Caviar Nourishing Daily Cream GLYCERIN, DIMETHICONE CREAM TOPICAL 20170627 OTC MONOGRAPH FINAL part347 FW1 R&D_Branch GLYCERIN; DIMETHICONE 13.7; 1 mg/50mL; mg/50mL N 20181231 70519-005_f8214ce0-2c44-4fa2-8a17-2054d944f95c 70519-005 HUMAN OTC DRUG Prestige Caviar Super Aqua Serum NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170627 UNAPPROVED DRUG OTHER FW1 R&D_Branch NIACINAMIDE; ADENOSINE 1; .02 mg/50mL; mg/50mL N 20181231 70520-0001_2d6b4236-8581-3dbd-e054-00144ff8d46c 70520-0001 HUMAN OTC DRUG Beaute de Cell Lifting-Up Multi Cream SPF 30 PA Zinc Oxide CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part347 Dracell Cosmetics Co., Ltd ZINC OXIDE 1.92 g/100mL N 20181231 70520-0002_2d6ab779-a5b6-5d97-e054-00144ff88e88 70520-0002 HUMAN OTC DRUG Beaute de Cell Perfect Sun-Shield SPF 50 PA Titanium dioxide CREAM TOPICAL 20160204 UNAPPROVED DRUG OTHER Dracell Cosmetics Co., Ltd TITANIUM DIOXIDE 3.85 g/100mL N 20181231 70520-0003_2d6ab779-a5b7-5d97-e054-00144ff88e88 70520-0003 HUMAN OTC DRUG Beaute de Cell Homme Perfect Sun-Shield SPF 50 PA Zinc Oxide CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part347 Dracell Cosmetics Co., Ltd ZINC OXIDE 5.0016 g/100mL N 20181231 70522-001_6067f927-ac01-500b-e053-2a91aa0ae1cf 70522-001 HUMAN OTC DRUG DT Collagen Octocrylene CREAM TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 DT Collagen, Inc. HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; AVOBENZONE 10; 10; 7.5; 5; 3.5 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 70527-001_322f78b1-3a38-12f4-e054-00144ff8d46c 70527-001 HUMAN OTC DRUG Sabiway, Hair Re-Growth Rosemary (Rosmarinus officinalis) leaf extract SHAMPOO TOPICAL 20160309 UNAPPROVED HOMEOPATHIC Navarrete Estacio Fernando ROSEMARY 1 [hp_X]/10mL E 20171231 70528-018_971e664f-278b-42de-b15c-a86cee7c44a3 70528-018 HUMAN OTC DRUG ZRII NEW DAY BROAD SPECTRUM SPF-30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20160705 OTC MONOGRAPH FINAL part352 ZRII, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 3; 5; 5; 2.7; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 70529-061_bb0cd799-020b-40bf-b009-5c12f8586404 70529-061 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20160726 ANDA ANDA077293 IT3 Medical LLC FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 70529-136_44655042-b3b8-4ba1-acb6-8d80a110d9ae 70529-136 HUMAN PRESCRIPTION DRUG Amphenol-40 Sodium Chloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20170301 NDA AUTHORIZED GENERIC NDA018803 IT3 Medical LLC SODIUM CHLORIDE 9 mg/mL Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20181231 70529-254_c71add54-934f-48fd-9022-d0b70f0fce71 70529-254 HUMAN PRESCRIPTION DRUG Venipuncture Px1 Lidocaine Hydrochloride KIT 20160501 ANDA ANDA040433 IT3 Medical LLC N 20191231 70529-290_6b4d6646-29c6-416a-846d-65c428106e1b 70529-290 HUMAN PRESCRIPTION DRUG Vitamin Deficiency Injectable System - B12 Cyanocobalamin KIT 20160501 ANDA ANDA080515 IT3 Medical LLC N 20191231 70529-441_6a9cab10-e1ee-4d8f-9c51-af85dc2af450 70529-441 HUMAN PRESCRIPTION DRUG DX1 OraGenomic Medicated DNA Collection Screen Lidocaine Hydrochloride KIT 20160501 ANDA ANDA040014 IT3 Medical LLC N 20191231 70529-442_815ee386-5744-445a-b883-3ae7331a19cc 70529-442 HUMAN PRESCRIPTION DRUG DX2 OraGenomic Medicated DNA Collection Screen Lidocaine Hydrochloride KIT 20160501 ANDA ANDA040014 IT3 Medical LLC N 20191231 70529-549_526c46f4-1491-478c-a944-4d7f08570d46 70529-549 HUMAN PRESCRIPTION DRUG TOXYCOLOGY Medicated Collection System Furosemide KIT 20160727 ANDA ANDA077293 IT3 Medical LLC N 20191231 70529-550_e69a1faa-ce50-4abf-be3a-74fdf56b58d9 70529-550 HUMAN PRESCRIPTION DRUG Diascreen 12-Panel Medicated Collection System Furosemide KIT 20160727 ANDA ANDA077293 IT3 Medical LLC N 20191231 70529-941_c8ec893b-793f-425c-b0d1-7b341e5d2ccc 70529-941 HUMAN PRESCRIPTION DRUG Sx1 Medicated Post-Operative System Lidocaine Hydrochloride KIT 20160501 ANDA ANDA040433 IT3 Medical LLC N 20191231 70532-001_3035b119-79da-61a1-e054-00144ff8d46c 70532-001 HUMAN OTC DRUG Elixir FINE Sunscreen Broad Spectrum SPF 15 AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 IXXI S.A.S. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 30; 75; 75 mg/mL; mg/mL; mg/mL E 20171231 70532-002_2fade6d6-e059-62e8-e054-00144ff88e88 70532-002 HUMAN OTC DRUG Inixial Perfection MATT BALANCING CARE Salicylic Acid 2% Acne Treatment SALICYLIC ACID CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part333D IXXI S.A.S. SALICYLIC ACID 20 mg/mL E 20171231 70532-003_2fadeab1-768e-62ee-e054-00144ff88e88 70532-003 HUMAN OTC DRUG Inixial Perfection PURITY Salicylic Acid 0.5% Acne Treatment SALICYLIC ACID LIQUID TOPICAL 20160401 OTC MONOGRAPH FINAL part333D IXXI S.A.S. SALICYLIC ACID 5 mg/mL E 20171231 70532-004_2faded42-9896-0316-e054-00144ff8d46c 70532-004 HUMAN OTC DRUG Inixial Perfection STOP BLEMISHES Salicylic Acid 2% Acne Treatment SALICYLIC ACID CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part333D IXXI S.A.S SALICYLIC ACID 20 mg/mL E 20171231 70532-005_2fadeab1-769b-62ee-e054-00144ff88e88 70532-005 HUMAN OTC DRUG Pearlixime ILLUMINATING PERFECTING Sunscreen Broad Spectrum SPF 15 AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 IXXI S.A.S. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 30; 75; 100 mg/mL; mg/mL; mg/mL E 20171231 70533-001_2fab0ad2-7453-53fc-e054-00144ff8d46c 70533-001 HUMAN OTC DRUG Daily Face Broad Spectrum ZINC OXIDE LOTION TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Harry's, Inc. ZINC OXIDE 66 mg/mL N 20181231 70533-002_2fab0ad2-7443-53fc-e054-00144ff8d46c 70533-002 HUMAN OTC DRUG Lip Balm SPF OCTINOXATE, ZINC OXIDE STICK TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Harry's, Inc. OCTINOXATE; ZINC OXIDE 75; 60 mg/g; mg/g E 20171231 70537-001_2fa99cd4-9520-433c-b2c3-2abb19ebab8e 70537-001 HUMAN OTC DRUG Red Oil Menthol and Camphor OIL TOPICAL 20160404 OTC MONOGRAPH FINAL part341 The Red Oil Company MENTHOL; CAMPHOR (SYNTHETIC) 10; 10 mg/mL; mg/mL E 20171231 70539-001_15395e7c-def6-4993-be31-7a3e238808ed 70539-001 HUMAN PRESCRIPTION DRUG Tymlos abaloparatide INJECTION, SOLUTION SUBCUTANEOUS 20170501 NDA NDA208743 Radius Health, Inc. ABALOPARATIDE 2000 ug/mL Parathyroid Hormone-Related Peptide Analog [EPC],Parathyroid Hormone-Related Protein [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 70540-010_0cbd73f2-6294-42d8-8fd9-80c78395d518 70540-010 HUMAN OTC DRUG MEDECEAN SEBORRHEA PYRITHIONE ZINC SHAMPOO TOPICAL 20160201 OTC MONOGRAPH FINAL part358H INNOGENE CO.,LTD PYRITHIONE ZINC 3 g/300g N 20181231 70540-020_cad7017a-d9c2-4799-a488-0356d7774356 70540-020 HUMAN OTC DRUG BALLVIC SEBO PYRITHIONE ZINC SHAMPOO TOPICAL 20160201 OTC MONOGRAPH FINAL part358H INNOGENE CO.,LTD PYRITHIONE ZINC 2.3 g/230g N 20181231 70540-030_245220e7-cc83-4f8f-a01b-acf72e6c59c1 70540-030 HUMAN OTC DRUG HYUNDAE MEDITECH BIO HAIR SOLU TION ERUA DO Allantoin SOLUTION TOPICAL 20160820 OTC MONOGRAPH FINAL part347 INNOGENE CO.,LTD ALLANTOIN .04 g/5g N 20181231 70540-040_fd020cf0-9004-446e-add0-54131a7b4893 70540-040 HUMAN OTC DRUG Dr MEDECEAN Rising Sun Cover Octinoxate, Titanium Dioxide, Octisalate CREAM TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part352 INNOGENE CO.,LTD OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 4; 1.5; 1 g/50g; g/50g; g/50g N 20181231 70540-050_ca1487c0-bc10-4581-9dd5-a1c91856dcfe 70540-050 HUMAN OTC DRUG Dr MEDECEAN Return Whitening Essence Dimethicone, Allantoin LIQUID TOPICAL 20170901 OTC MONOGRAPH FINAL part347 INNOGENE CO.,LTD DIMETHICONE; ALLANTOIN 1.2; .2 g/40g; g/40g N 20181231 70541-010_536c2f2e-eb3d-42f1-b15f-0ee6f19337df 70541-010 HUMAN OTC DRUG Madeca Derma Mask Glycerin, Niacinamide PATCH TOPICAL 20160201 UNAPPROVED DRUG OTHER Dongkook Pharmaceutical Co., Ltd. GLYCERIN; NIACINAMIDE 10; 4 g/101; g/101 N 20181231 70541-020_1c0e801b-99c9-498f-b8fb-0c12b4398d96 70541-020 HUMAN OTC DRUG Madeca Glycerin, Niacinamide CREAM TOPICAL 20160201 UNAPPROVED DRUG OTHER Dongkook Pharmaceutical Co., Ltd. GLYCERIN; NIACINAMIDE 1; 1 g/50mL; g/50mL N 20181231 70541-030_71faec87-676d-4f5d-9275-015acd6199ab 70541-030 HUMAN OTC DRUG Madeca Derma Mask II Glycerin, Niacinamide PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER Dongkook Pharmaceutical Co., Ltd. GLYCERIN; NIACINAMIDE 1.25; .5 g/25mL; g/25mL N 20181231 70541-040_fcdcebd9-e5ab-41e6-b3b5-26c8b84c59bf 70541-040 HUMAN OTC DRUG Madeca Derma Intensive Vital DIMETHICONE CREAM TOPICAL 20171001 OTC MONOGRAPH FINAL part347 Dongkook Pharmaceutical Co., Ltd. DIMETHICONE .58 g/50mL N 20181231 70541-050_6bba1c4d-5733-418d-995b-edc7baa51e13 70541-050 HUMAN OTC DRUG Madeca Derma Ultra Moisture Hydroge l Mask Niacinamide, Adenosine PATCH TOPICAL 20171001 UNAPPROVED DRUG OTHER Dongkook Pharmaceutical Co., Ltd. NIACINAMIDE; ADENOSINE .6; .01 g/30g; g/30g N 20181231 70541-060_8472b735-3208-4e05-81ba-f11e223c6b0c 70541-060 HUMAN OTC DRUG Madeca Derma Time Reverse Vitalizing Night Mask DIMETHICONE CREAM TOPICAL 20171001 OTC MONOGRAPH FINAL part347 Dongkook Pharmaceutical Co., Ltd. DIMETHICONE 1.02 g/50mL N 20181231 70542-301_46c9fa02-a0c8-72c1-e054-00144ff8d46c 70542-301 HUMAN OTC DRUG Maxim PCMX, Hand Soap SOAP TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A Midlab Incorporated CHLOROXYLENOL .1 g/L N 20181231 70542-302_46ca97c9-cb6f-2ca9-e054-00144ff88e88 70542-302 HUMAN OTC DRUG Puro Azul Awapuhi PCMX, Hand Soap SOAP TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A Midlab Incorporated CHLOROXYLENOL .1 g/L N 20181231 70542-303_46cb74a5-defd-34c9-e054-00144ff8d46c 70542-303 HUMAN OTC DRUG Bright Solutions antiseptic PCMX, Hand Soap SOAP TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A Midlab Incorporated CHLOROXYLENOL .1 g/L N 20181231 70542-304_46cbc151-30bc-4ad4-e054-00144ff88e88 70542-304 HUMAN OTC DRUG Victoria Bay PCMX Hand Soap SOAP TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A Midlab Incorporated CHLOROXYLENOL .1 g/L N 20181231 70542-305_46d82fd0-4246-252d-e054-00144ff88e88 70542-305 HUMAN OTC DRUG Fivestar PCMX Hand Soap SOAP TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A Midlab Incorporated CHLOROXYLENOL .1 g/L N 20181231 70542-306_46d87af7-dbcf-2e52-e054-00144ff88e88 70542-306 HUMAN OTC DRUG Mline PCMX Hand Soap SOAP TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A Midlab Incorporated CHLOROXYLENOL .1 g/L N 20181231 70542-307_46d8d0d7-0de9-09cd-e054-00144ff8d46c 70542-307 HUMAN OTC DRUG Radiance PCMX Hand Soap SOAP TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A Midlab Incorporated CHLOROXYLENOL .1 g/L N 20181231 70542-501_54d50747-7749-59f0-e054-00144ff8d46c 70542-501 HUMAN OTC DRUG Maxim Instant Foam Hand Sanitizer Benzalkonium Chloride SOAP TOPICAL 20170711 OTC MONOGRAPH NOT FINAL part333A Midlab Incoporated BENZALKONIUM CHLORIDE .1 mg/mL N 20181231 70542-701_45c37f14-ce7d-523c-e054-00144ff88e88 70542-701 HUMAN OTC DRUG Maxim Assure PCMX, Dishwashing and Hand Soap SOAP TOPICAL 20170112 OTC MONOGRAPH NOT FINAL part333A Midlab Incorporated CHLOROXYLENOL .1 g/L N 20181231 70542-702_45b09d7f-5e6b-29f7-e054-00144ff88e88 70542-702 HUMAN OTC DRUG Compliance PCMX, Dishwashing and Hand Soap SOAP TOPICAL 20170112 OTC MONOGRAPH NOT FINAL part333A Midlab Incorporated CHLOROXYLENOL .1 g/L N 20181231 70542-703_45c4089f-e8c9-65ea-e054-00144ff8d46c 70542-703 HUMAN OTC DRUG RoyaLab Germ Away PCMX, Dishwashing and Hand Soap SOAP TOPICAL 20170112 OTC MONOGRAPH NOT FINAL part333A Midlab Incorporated CHLOROXYLENOL .1 g/L N 20181231 70542-704_562c9cab-b770-2e11-e054-00144ff88e88 70542-704 HUMAN OTC DRUG Soft Touch PCMX, Dishwashing and Hand Soap SOAP TOPICAL 20170807 OTC MONOGRAPH NOT FINAL part333A Midlab Incorporated CHLOROXYLENOL .1 g/L N 20181231 70544-001_314e438a-5706-5f39-e054-00144ff8d46c 70544-001 HUMAN OTC DRUG PHQUIROGEL CAMPHOR, MENTHOL GEL TOPICAL 20160404 OTC MONOGRAPH NOT FINAL part348 Issislen Laboratori S.L. CAMPHOR (SYNTHETIC); MENTHOL 30.1; 21 mg/mL; mg/mL E 20171231 70545-010_6276e1ff-ba70-41c9-88a9-e868a0a278c3 70545-010 HUMAN OTC DRUG Dr VITA Mask Pack C Whitening Effect Witch Hazel PATCH TOPICAL 20160201 OTC MONOGRAPH FINAL part347 DAYCELL COSMETICS CO., LTD. WITCH HAZEL .07 g/101 E 20171231 70545-020_42adf2a6-a30f-4785-809d-0b2f447e3b40 70545-020 HUMAN OTC DRUG Dr VITA Premium Vitamin C DIMETHICONE CREAM TOPICAL 20160201 OTC MONOGRAPH FINAL part347 DAYCELL COSMETICS CO., LTD. DIMETHICONE .9 g/30g E 20171231 70549-123_332e40fb-70a4-2e4f-e054-00144ff8d46c 70549-123 HUMAN OTC DRUG ANTIDANDRUFF PYRITHIONE ZINC SHAMPOO TOPICAL 20160601 OTC MONOGRAPH FINAL part358H BBCOS S.R.L. PYRITHIONE ZINC 10 mg/1000mg E 20171231 70550-000_46db88c8-bbbd-0f9e-e054-00144ff88e88 70550-000 HUMAN OTC DRUG Recapture Day Plus IR Defense AVOBENZONE, OCTOCRYLENE, and OCTINOXATE CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part352 Atlantic Coast Media Group, LLC. AVOBENZONE; OCTOCRYLENE; OCTINOXATE 30; 42; 75 mg/mL; mg/mL; mg/mL N 20181231 70550-001_46dbccd8-54a4-3c4a-e054-00144ff8d46c 70550-001 HUMAN OTC DRUG Recapture 360 Day plus IR Defense AVOBENZONE, OCTOCRYLENE, and OCTINOXATE CREAM TOPICAL 20150301 OTC MONOGRAPH FINAL part352 Atlantic Coast Media Group, LLC. AVOBENZONE; OCTOCRYLENE; OCTINOXATE 30; 42; 75 mg/mL; mg/mL; mg/mL N 20181231 70551-001_339bba66-0f7b-2e86-e054-00144ff8d46c 70551-001 HUMAN OTC DRUG KGS Zhitong Gao Medicated Plaster Extra Strength Methyl Salicylate Menthol Camphor PATCH TOPICAL 20160314 OTC MONOGRAPH NOT FINAL part348 Huangshi Likang Pharmaceutical Co.,Ltd. METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 13; 9; 11 g/1; g/1; g/1 N 20181231 70551-002_33d56a0a-b024-73bb-e054-00144ff8d46c 70551-002 HUMAN OTC DRUG KGS Bao Zhen Gao Medicated Plaster Extra Strength Methyl Salicylate Menthol Camphor PATCH TOPICAL 20160509 OTC MONOGRAPH NOT FINAL part348 Huangshi Likang Pharmaceutical Co.,Ltd. METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 14; 7; 7 g/1; g/1; g/1 N 20181231 70553-731_47f4dfd4-b817-4c18-e054-00144ff88e88 70553-731 HUMAN OTC DRUG Ocean Friendly Sunscreen SPF30 Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20160315 OTC MONOGRAPH NOT FINAL part352 Lemongrass Spa Products LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 70554-732_4830e6dc-df6f-3e62-e054-00144ff8d46c 70554-732 HUMAN OTC DRUG You Relief Muscle and Joint Rub MENTHOL CREAM TOPICAL 20160316 OTC MONOGRAPH NOT FINAL part348 The Feel Good Lab, LLC MENTHOL 12.5 mg/mL N 20181231 70554-846_5a050880-e3c3-4d54-e053-2991aa0a6da6 70554-846 HUMAN OTC DRUG FEEL GOOD YOU PLUS Relief, Pain Relief MENTHOL CREAM TOPICAL 20170923 OTC MONOGRAPH NOT FINAL part348 Feel Good Lab, LLC MENTHOL 12.5 mg/mL N 20181231 70554-848_5ab96d5d-755f-77ff-e053-2991aa0a1684 70554-848 HUMAN OTC DRUG You Plus Relief Pain Relieving MENTHOL CREAM TOPICAL 20171004 OTC MONOGRAPH NOT FINAL part348 The Feel Good Lab LLC MENTHOL 12.5 mg/mL N 20181231 70555-007_99d41f79-d0fc-4d94-bfa1-5c17f7e2a4d4 70555-007 HUMAN OTC DRUG Youth for Life SPF 30 Octinoxate and Avobenzone LOTION TOPICAL 20160324 OTC MONOGRAPH FINAL part352 Youth for Life OCTINOXATE; AVOBENZONE 40; 25 mg/g; mg/g E 20171231 70557-002_318be153-c512-5b85-e054-00144ff8d46c 70557-002 HUMAN OTC DRUG Benchmarks Derma Shield Dimethicone AEROSOL TOPICAL 20160427 OTC MONOGRAPH FINAL part347 Delta Kits Inc DIMETHICONE 2.7 g/100g N 20181231 70557-002_38b3b743-bded-26a1-e054-00144ff88e88 70557-002 HUMAN OTC DRUG Benchmarks Derma Shield Dimethicone AEROSOL TOPICAL 20160427 OTC MONOGRAPH FINAL part347 Delta Kits Inc DIMETHICONE 2.7 g/100g N 20181231 70557-002_38b3b743-bdee-26a1-e054-00144ff88e88 70557-002 HUMAN OTC DRUG Benchmarks Derma Shield Dimethicone AEROSOL TOPICAL 20160427 OTC MONOGRAPH FINAL part347 Delta Kits Inc DIMETHICONE 2.7 g/100g N 20181231 70558-0001_1d7051a1-850b-4d1c-b0e6-b93edaa4e5de 70558-0001 HUMAN OTC DRUG Weight Management Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Brain (Suis), Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), AACG-A, AACG-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-KETO-DHEA (3- Acetyl-Oxo-Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (Suis), Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20160413 UNAPPROVED HOMEOPATHIC Pro Weight Loss Inc. CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; SUS SCROFA CEREBRUM; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 70558-0002_fee4bf98-1d59-4dec-a436-5bb1837ab210 70558-0002 HUMAN OTC DRUG Detox Beta Vulgaris, Boldo, Chelidonium Majus, Sarsaparilla (Smilax Regelii), Gelsemium Sempervirens, Veratrum Album, Ferrum Metallicum, Iodium, Lycopodium Clavatum, Nux Vomica, Pulsatilla (Vulgaris), Selenium Metallicum, Thuja Occidentalis, Zincum Metallicum LIQUID ORAL 20160414 UNAPPROVED HOMEOPATHIC Pro Weight Loss Inc. BETA VULGARIS; CHELIDONIUM MAJUS; SMILAX REGELII ROOT; GELSEMIUM SEMPERVIRENS ROOT; VERATRUM ALBUM ROOT; IRON; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SELENIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 3; 3; 6; 7; 7; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 70564-802_1f132951-84d1-4e66-b647-675befa443e6 70564-802 HUMAN PRESCRIPTION DRUG MYTESI Crofelemer TABLET, COATED ORAL 20160801 NDA NDA202292 Napo Pharmaceuticals, Inc. CROFELEMER 125 mg/1 Antidiarrheal [EPC] E 20171231 70565-580_3e0b2017-5e0d-44a4-9431-afd15bcb7822 70565-580 HUMAN OTC DRUG Sal de Uvas Picot Citric Acid monohydrate and Sodium bicarbonate GRANULE, EFFERVESCENT ORAL 20160331 OTC MONOGRAPH FINAL part331 Reckitt Benckiser Mexico, S.A. de C.V. CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE 1.9485; 2.485 g/1; g/1 N 20181231 70566-010_82f20648-6cb7-485c-bfd3-2ea23280fbc9 70566-010 HUMAN OTC DRUG AC Control Daily Mask Glycerin SOLUTION TOPICAL 20160201 UNAPPROVED DRUG OTHER MODECOS CO., LTD. GLYCERIN 1.8 g/101 E 20171231 70566-020_04646f3e-0686-4fa8-bf89-f40e9d8d4d2f 70566-020 HUMAN OTC DRUG Water Full Daily Mask Witch Hazel SOLUTION TOPICAL 20160201 OTC MONOGRAPH FINAL part347 MODECOS CO., LTD. WITCH HAZEL .03 g/101 E 20171231 70566-030_568b33a3-bf77-40dd-a498-6de6d12190ff 70566-030 HUMAN OTC DRUG Collagen Plus Daily Mask Witch Hazel SOLUTION TOPICAL 20160201 OTC MONOGRAPH FINAL part347 MODECOS CO., LTD. WITCH HAZEL .03 g/101 E 20171231 70566-040_4d688ad3-a134-4e2f-8dd5-bd1e3d76ab77 70566-040 HUMAN OTC DRUG ALL IN ONE DUAL MASK Glycerin PATCH TOPICAL 20160201 OTC MONOGRAPH FINAL part347 MODECOS CO., LTD. GLYCERIN 3 g/101 E 20171231 70567-010_e8f1f2be-1bbf-49a4-8a07-50f494c3e357 70567-010 HUMAN OTC DRUG Pibubab Prestige Grain Ampule SESAME SOLUTION TOPICAL 20160302 UNAPPROVED DRUG OTHER KHLEEKOREA SESAME OIL 8.75 g/25mL N 20181231 70567-020_b23537b3-6d94-400c-a4d1-d667837939b5 70567-020 HUMAN OTC DRUG Pibubab gold Grain Pack SESAME SEED POWDER TOPICAL 20160302 UNAPPROVED DRUG OTHER KHLEEKOREA SESAME SEED 1.2 g/10g N 20181231 70567-030_72ad9ff4-8843-40b1-b8a0-af93f31d40d4 70567-030 HUMAN OTC DRUG Pibubab Grain Total Wrinkle Brake Dimethicone CREAM TOPICAL 20160302 OTC MONOGRAPH FINAL part347 KHLEEKOREA DIMETHICONE 1 g/20mL N 20181231 70567-040_f9b118bf-ab59-4679-852e-d85b4cfe419f 70567-040 HUMAN OTC DRUG Grain Vita Fermented Dimethicone CREAM TOPICAL 20160302 OTC MONOGRAPH FINAL part347 KHLEEKOREA DIMETHICONE 1 g/50mL N 20181231 70567-050_a3edb2df-2890-44f1-a227-db03e924c2a5 70567-050 HUMAN OTC DRUG Grain Timeless Gold Placenta Dimethicone CREAM TOPICAL 20160302 UNAPPROVED DRUG OTHER KHLEEKOREA DIMETHICONE .2 g/50mL N 20181231 70567-060_a907efeb-4a74-47d5-9b51-5f8a4f70be2b 70567-060 HUMAN OTC DRUG Grain Timeless Perfection Dimethicone CREAM TOPICAL 20160302 OTC MONOGRAPH FINAL part347 KHLEEKOREA DIMETHICONE 2 g/50mL N 20181231 70567-070_20576766-9240-44cb-9b47-d5b8080de278 70567-070 HUMAN OTC DRUG Grain Timeless Perfection Essence Dimethicone CREAM TOPICAL 20160302 UNAPPROVED DRUG OTHER KHLEEKOREA DIMETHICONE .2 g/40mL N 20181231 70567-080_0dd69773-afe9-4366-b517-c689ca636e83 70567-080 HUMAN OTC DRUG Grain Timeless Perfection Glycerin SOLUTION TOPICAL 20160302 UNAPPROVED DRUG OTHER KHLEEKOREA GLYCERIN 8.7 g/145mL N 20181231 70569-840_321e94ba-4baa-4392-e054-00144ff88e88 70569-840 HUMAN PRESCRIPTION DRUG GIALAX Polyethylene Glycol 3350 KIT ORAL 20111001 ANDA ANDA076652 Phlight Pharma, LLC N 20181231 70570-0197_6e5fa317-ffd2-46fd-b14a-f5871e814d29 70570-0197 HUMAN OTC DRUG Gas Relief Drops Dimethicone LIQUID ORAL 20150201 OTC MONOGRAPH FINAL part332 Arymar Inc. DIMETHICONE 20 mg/.3mL E 20171231 70570-0198_4273d448-3011-4e38-81a4-a17145544216 70570-0198 HUMAN OTC DRUG Micocilen Undecylenic Acid CREAM TOPICAL 20150201 OTC MONOGRAPH FINAL part333C Arymar Inc. UNDECYLENIC ACID 150 mg/mL E 20171231 70570-0199_f7eead7f-d04d-439c-b7bb-5e54e99756b8 70570-0199 HUMAN OTC DRUG Micocilen Antifungal Undecylenic Acid LIQUID TOPICAL 20140301 OTC MONOGRAPH FINAL part333C Arymar Inc. UNDECYLENIC ACID 250 mg/mL E 20171231 70574-0001_30f6379e-23ef-5a3b-e054-00144ff88e88 70574-0001 HUMAN OTC DRUG ACCOJE SUNSCREEN (SPF50 Broad Spectrum) ZINC OXIDE CREAM TOPICAL 20160204 OTC MONOGRAPH FINAL part347 Ucl Co., Ltd. ZINC OXIDE 4.97 g/100mL E 20171231 70576-001_2faf7119-4075-497d-e054-00144ff8d46c 70576-001 HUMAN OTC DRUG Pain Relief Cream Camphor CREAM TOPICAL 20160330 OTC MONOGRAPH NOT FINAL part348 Health Town Inc CAMPHOR (NATURAL) 1 g/100g E 20171231 70580-101_09f6669e-c1f0-4ffd-a306-d8b546cf0648 70580-101 HUMAN OTC DRUG Broad Spectrum Face and Body Sunscreen Stick SPF 30 Zinc oxide STICK TOPICAL 20160405 OTC MONOGRAPH NOT FINAL part352 Ct Organics Llc ZINC OXIDE 20 g/100g E 20171231 70582-999_5cca8178-9e13-7022-e053-2991aa0aea8f 70582-999 HUMAN OTC DRUG BonaDur lidocaine SPRAY TOPICAL 20150724 OTC MONOGRAPH NOT FINAL part348 WebRx Pharmacy Palace LIDOCAINE HYDROCHLORIDE 10 mg/mg N 20181231 70583-733_47f4f989-fafe-6576-e054-00144ff8d46c 70583-733 HUMAN OTC DRUG Dr. Harveys Herbal Motion Pain Formula CAPSAICIN CREAM TOPICAL 20160329 OTC MONOGRAPH NOT FINAL part348 Herbal Motion LLC CAPSAICIN .27 mg/g N 20181231 70584-734_47f4d4c4-fb47-5e0e-e054-00144ff8d46c 70584-734 HUMAN OTC DRUG Neurolatore Power Formula Pain Relief METHYL SALICYLATE, MENTHOL CREAM TOPICAL 20160329 OTC MONOGRAPH NOT FINAL part348 Miracle Breakthrough Labs Corporation METHYL SALICYLATE; MENTHOL 185; 90 mg/g; mg/g N 20181231 70585-111_7e9f41bc-f38d-4c1a-baad-b06883188ef0 70585-111 HUMAN OTC DRUG PROZERO MENTHOL GEL TOPICAL 20160809 OTC MONOGRAPH NOT FINAL part348 RLABS, LLC MENTHOL 5 g/100mL E 20171231 70589-100_60ce0e85-bf81-099f-e053-2991aa0a9989 70589-100 HUMAN OTC DRUG HER LH2473 Vanilla Scented Hand Sanitizer Kit Alcohol KIT 20160930 OTC MONOGRAPH NOT FINAL part333E HER ACCESSORIES N 20181231 70589-102_60ce0e85-bf76-099f-e053-2991aa0a9989 70589-102 HUMAN OTC DRUG HER LH2475 Vanilla Scented Hand Sanitizer Kit Alcohol KIT 20160930 OTC MONOGRAPH NOT FINAL part333E HER ACCESSORIES N 20181231 70589-104_60ce49e6-e55f-94aa-e053-2a91aa0ab8ec 70589-104 HUMAN OTC DRUG HER LH2476 Citrus Scented Hand Sanitizer Kit Alcohol KIT 20160930 OTC MONOGRAPH NOT FINAL part333E HER ACCESSORIES N 20181231 70589-106_60ce6601-a303-4c34-e053-2991aa0adaff 70589-106 HUMAN OTC DRUG HER LH2484 Strawberry Scented Hand Sanitizer Kit Alcohol KIT 20160930 OTC MONOGRAPH NOT FINAL part333E HER ACCESSORIES N 20181231 70589-108_60ce6601-a30d-4c34-e053-2991aa0adaff 70589-108 HUMAN OTC DRUG HER LT279 Vanilla Limited Too Hand Sanitizer Kit Alcohol KIT 20160930 OTC MONOGRAPH NOT FINAL part333E HER ACCESSORIES N 20181231 70589-110_60ce5a78-156c-ae74-e053-2a91aa0ad116 70589-110 HUMAN OTC DRUG HER LT288 Citrus Limited Too Hand Sanitizer Kit Alcohol KIT 20160930 OTC MONOGRAPH NOT FINAL part333E HER ACCESSORIES N 20181231 70589-112_60ce6601-a317-4c34-e053-2991aa0adaff 70589-112 HUMAN OTC DRUG HER LT289 Vanilla Limited Too Hand Sanitizer Kit Alcohol KIT 20160930 OTC MONOGRAPH NOT FINAL part333E HER ACCESSORIES N 20181231 70589-114_60ce6f0e-1dcc-54db-e053-2991aa0aabc6 70589-114 HUMAN OTC DRUG HER LT297 Strawberry Limited Too Sanitizer Kit Alcohol KIT 20160930 OTC MONOGRAPH NOT FINAL part333E HER ACCESSORIES N 20181231 70591-010_b230d2d1-f2ea-417f-9b33-4d77c8f12f8c 70591-010 HUMAN OTC DRUG ANYPACK GOLD SEASON SECOND SKIN HYDRO FACE MASK Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 2.7 g/27g N 20181231 70591-020_0d585623-3c53-482e-b9bd-d117ae9742bc 70591-020 HUMAN OTC DRUG ANYPACK CRYSTA L SEASON SECOND SKIN HYDRO FACE MASK Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 1.89 g/27g N 20181231 70591-030_ce7a36e4-7a0d-436b-b7b3-c19f9cc61d44 70591-030 HUMAN OTC DRUG ANYPACK POMEGRANATE SHEET MASK Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 1.65 g/22mL N 20181231 70591-040_410727de-b8f4-4ef5-8865-f484fb326eec 70591-040 HUMAN OTC DRUG ANYPACK POMEGRANATE TENCEL MASK Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 1.65 g/22mL N 20181231 70591-050_7a803e13-3961-4281-adc3-3de25ae9d010 70591-050 HUMAN OTC DRUG ANYPACK ALOE VERA SHEET MASK Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 1.65 g/22mL N 20181231 70591-060_07d57ad5-8967-4871-9ea3-1ec98b4e420c 70591-060 HUMAN OTC DRUG ANYPACK ALOE VERA TENCEL MASK Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 1.65 g/22mL N 20181231 70591-070_4eae4f7b-6058-468f-a9d4-a35faa0ef703 70591-070 HUMAN OTC DRUG ANYPACK ROYAL JEL LY SHEET MASK Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 1.65 g/22mL N 20181231 70591-080_2d2069dd-b19b-4205-8fac-f1b36e6e6f5f 70591-080 HUMAN OTC DRUG ANYPACK ROYAL JEL LY TENCEL MASK Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 1.65 g/22mL N 20181231 70591-090_b62c6e07-5e2f-4e84-b00e-7781ebf3a099 70591-090 HUMAN OTC DRUG ANYPACK PEARL SHEET MASK Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 1.65 g/22mL N 20181231 70591-100_b025b1ba-ffa2-4244-9cff-cf83f9680348 70591-100 HUMAN OTC DRUG ANYPACK PEARL TENCEL MASK Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 1.65 g/22mL N 20181231 70591-110_6e266447-1709-4ccc-9f51-354a88bfa830 70591-110 HUMAN OTC DRUG BeauBeaute Collagen Hydroge l Essence Beauty Mask Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 1.75 g/25g N 20181231 70591-120_26ba717c-3a12-403d-bd26-0521a390151e 70591-120 HUMAN OTC DRUG BeauBeaute Placenta Hydroge l Essence Beauty Mask Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 1.75 g/25g N 20181231 70591-130_e5b16001-a568-455e-b83a-a273543c4a40 70591-130 HUMAN OTC DRUG ANYPACK Multi Active hydroge l Eye Glycerin PATCH TOPICAL 20160302 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 7 g/100g N 20181231 70591-140_7048f7e2-a0cf-4d69-989d-5346f4059ee0 70591-140 HUMAN OTC DRUG COMPLETE DERMASK Glycerin PATCH TOPICAL 20160815 UNAPPROVED DRUG OTHER JINCOSTECH CO.,LTD GLYCERIN 1.75 g/25g N 20181231 70592-010_362ca40f-ac01-4b06-97f1-6b9f0ad863dd 70592-010 HUMAN OTC DRUG FREEZE 24 7 RADIANCE BRIGHTENING FACE MASK Witch Hazel PATCH TOPICAL 20160302 OTC MONOGRAPH FINAL part347 Summit C&T LLC WITCH HAZEL .03 g/30mL E 20171231 70592-020_65af6684-efe0-4713-86b5-a92d151af842 70592-020 HUMAN OTC DRUG Freeze 24 7 Intense Hydrating Face Mask Witch Hazel PATCH TOPICAL 20160302 OTC MONOGRAPH FINAL part347 Summit C&T LLC WITCH HAZEL .03 g/30mL E 20171231 70592-030_c299583c-fab5-47ff-bd4b-741a3c40298d 70592-030 HUMAN OTC DRUG Freeze 24 7 Anti Gravity Lifting Face Mask Witch Hazel PATCH TOPICAL 20160302 OTC MONOGRAPH FINAL part347 Summit C&T LLC WITCH HAZEL .03 g/30mL E 20171231 70597-117_50ecfbe1-503d-0d71-e054-00144ff8d46c 70597-117 HUMAN OTC DRUG Skin Therapy Calm Thayers Colloidal Oatmeal 1 % CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part347 Harmony Herbal OATMEAL 1 g/100g N 20181231 70598-001_bbc9d8c6-6b15-41fd-84f0-cb61f2d7e028 70598-001 HUMAN OTC DRUG TetraNext Tetracycline Hydrochloride OINTMENT TOPICAL 20160801 OTC MONOGRAPH FINAL part333B Saxet Pharmaceuticals TETRACYCLINE HYDROCHLORIDE 30 mg/mL N 20181231 70599-424_06c018a4-293e-42b5-b77a-bb121501cb16 70599-424 HUMAN PRESCRIPTION DRUG ICG Indocyanine Green and Water KIT 20160601 ANDA ANDA040811 KARL STORZ Endoscopy-America, Inc. N 20181231 70602-001_ab2e010d-4eb8-4cb9-82e8-10d3d4d7bf34 70602-001 HUMAN OTC DRUG Exoden Powder CETYLPYRIDINIUM CHLORIDE, DOMIPHEN BROMIDE POWDER TOPICAL 20160407 UNAPPROVED DRUG OTHER LIFEON Corp. DOMIPHEN BROMIDE; CETYLPYRIDINIUM CHLORIDE .3; .084 1/70g; g/70g E 20171231 70602-002_91364930-1e82-4a72-b6ea-5654407d07a0 70602-002 HUMAN OTC DRUG Exoden White Tooth DOMIPHEN BROMIDE PASTE TOPICAL 20160407 UNAPPROVED DRUG OTHER LIFEON Corp. AMINOCAPROIC ACID; SILICON DIOXIDE .3; 7.5 g/150g; g/150g E 20171231 70603-010_a9a627f8-8f49-4ace-95da-a868ef6cd1dd 70603-010 HUMAN OTC DRUG Haishen 80 Sea Cucumber Nutritive Fresh DIMETHICONE CREAM TOPICAL 20160302 OTC MONOGRAPH FINAL part347 JUNGLEFOOD CO., LTD. DIMETHICONE .8 g/80g E 20171231 70603-020_62da1cea-099d-4833-8f3f-4a3f6a5e6bcf 70603-020 HUMAN OTC DRUG Haishen 80 Sea Cucumber Nutritive Fresh Mask WITCH HAZEL PATCH TOPICAL 20160302 OTC MONOGRAPH FINAL part347 JUNGLEFOOD CO., LTD. WITCH HAZEL .02 g/27g E 20171231 70603-030_5a60596b-5fb3-4afa-a405-ca3220079242 70603-030 HUMAN OTC DRUG Mari Huana real nature hemp seed NIACINAMIDE CREAM TOPICAL 20160302 UNAPPROVED DRUG OTHER JUNGLEFOOD CO., LTD. NIACINAMIDE 1.4 g/70g E 20171231 70603-040_07f1a005-74f4-433a-8500-14d685ceecc3 70603-040 HUMAN OTC DRUG Mari Huana Real Natural Sparkle Essence NIACINAMIDE CREAM TOPICAL 20160402 UNAPPROVED DRUG OTHER JUNGLEFOOD CO., LTD. NIACINAMIDE 2.8 g/140mL E 20171231 70604-010_5793b80a-b24d-47fb-b0de-08747308db71 70604-010 HUMAN OTC DRUG HydraTint Pro Mineral Broad Spectrum Sunscreen SPF 36 Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20170101 OTC MONOGRAPH FINAL part352 Alastin Skincare, Inc. TITANIUM DIOXIDE; ZINC OXIDE .089; .034 g/g; g/g N 20181231 70605-003_daf0cd71-fcea-476a-a59e-77bb00950ff1 70605-003 HUMAN OTC DRUG Meaningful Beauty Cindy Crawford Maintenance 1plus Daily Moisture SPF 20 UVA/UVB OCTISALATE, OXYBENZONE, OCTINOXATE, and ZINC OXIDE LOTION TOPICAL 20160430 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTISALATE; OXYBENZONE; OCTINOXATE; ZINC OXIDE 5; 5; 5; 3 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 70605-004_a69b81c6-c6c4-4032-9a74-d1442609aa88 70605-004 HUMAN OTC DRUG Meaningful Beauty Cindy Crawford Antioxidant SPF 20 UVA/UVB AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20160430 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 70605-006_601c1b73-bb78-4133-a2b3-5edec13fb739 70605-006 HUMAN OTC DRUG Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20160430 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 3; 7.5; 5; 5 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 70605-007_df63807c-19a2-435b-821e-1ce4205ea08e 70605-007 HUMAN OTC DRUG Meaningful Beauty Dark Spot Correcting Treatment HYDROQUINONE LOTION TOPICAL 20160430 OTC MONOGRAPH NOT FINAL part358A Guthy-Renker LLC HYDROQUINONE 2 g/100mL N 20181231 70605-008_60a6a31e-5eb3-4f75-a8a9-1944ab0917a2 70605-008 HUMAN OTC DRUG Meaningful Beauty BB Broad Spectrum SPF 15 (Light, Medium, Dark) OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20160430 OTC MONOGRAPH FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 mg/100mL; mg/100mL; mg/100mL N 20181231 70605-014_3690fb4c-45fe-40b3-8dfe-ecc92db88ca7 70605-014 HUMAN OTC DRUG Principal Secret Reclaim Sunscreen For Face and Body SPF 30 Meradimate, Octinoxate, Oxybenzone, and Zinc Oxide CREAM TOPICAL 20171130 OTC MONOGRAPH FINAL part352 Guthy-Renker LLC MERADIMATE; OCTINOXATE; OXYBENZONE; ZINC OXIDE 3.5; 7.5; 2; 3 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 70605-015_00f87d1d-cf2a-4d36-abff-1ac60794c6a1 70605-015 HUMAN OTC DRUG Meaningful Beauty Blemish Treatment Benzoyl Peroxide GEL TOPICAL 20160430 OTC MONOGRAPH FINAL part333D Guthy-Renker LLC BENZOYL PEROXIDE 5 g/100g N 20181231 70605-017_c71e9e1e-4200-4095-8821-50a193ae3f52 70605-017 HUMAN OTC DRUG Principal Secret Advanced with Hydrospheres Continuous Moisture SPF8 Octinoxate and Octisalate CREAM TOPICAL 20171231 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE 7.5; 1 g/100g; g/100g N 20181231 70605-018_ed52cc70-237e-42df-93c0-5cc62676df84 70605-018 HUMAN OTC DRUG Blemish Buster Solution Acne Treatment SULFUR CREAM TOPICAL 20171231 OTC MONOGRAPH FINAL part358H Guthy-Renker LLC SULFUR 10 mg/100mL N 20181231 70605-019_37a52869-ce9f-4364-b661-a4e96e223807 70605-019 HUMAN OTC DRUG Meaningful Beauty Cindy Crawford Maintenance 1 Daily Moisture SPF 8 OCTINOXATE and AVOBENZONE LOTION TOPICAL 20160430 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; AVOBENZONE 5; 3 mg/100mL; mg/100mL N 20181231 70605-024_5b705e7e-d60f-42a1-9ca1-310caeea75c5 70605-024 HUMAN OTC DRUG Sheer Cover Nourishing Moisturizer SPF 15 OCTINOXATE, OCTISALATE, and OXYBENZONE LOTION TOPICAL 20160531 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 mg/100mL; mg/100mL; mg/100mL N 20181231 70605-026_1f29bd4c-ee79-40ab-8630-1617aa9ec98a 70605-026 HUMAN OTC DRUG Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAs Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM TOPICAL 20171230 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker,LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 10; 5; 1.3; 4 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 70605-028_e9c8b1cd-fc6f-4e57-ada4-a616d4157393 70605-028 HUMAN OTC DRUG Principal Secret Reclaim Oil Control hydrator SPF-8 Titanium Dioxide CREAM TOPICAL 20171231 OTC MONOGRAPH FINAL part352 Guthy-Renker LLC TITANIUM DIOXIDE 4 mg/100mL N 20181231 70605-029_726b48a9-d7bd-47b0-827d-61a36ece1e9b 70605-029 HUMAN OTC DRUG Principal Secret Reclaim Botanical (with SP) Radiant Recovery Day Broad Spectrum SPF 15 Octinoxate, Octisalate, and Zinc Oxide CREAM TOPICAL 20160430 OTC MONOGRAPH FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 3 g/100g; g/100g; g/100g N 20181231 70605-041_2e473c7b-acee-4be1-9e22-d5eed3c50776 70605-041 HUMAN OTC DRUG LUMIPEARL PERFECT AND PROTECT DAY BROAD SPECTRUM SPF 25 SUNSCREEN Homosalate, Octisalate, Oxybenzone, Avobenzone, and Octocrylene CREAM TOPICAL 20160531 OTC MONOGRAPH FINAL part352 Guthy-Renker LLC HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 8; 5; 3; 3; 2.7 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL E 20171231 70605-042_3bbc33f3-3ccd-45d2-8f5f-bc25d8e9658e 70605-042 HUMAN OTC DRUG Reclaim Revolutionary Anti-Aging Day SPF15 Octinoxate, Octisalate, and Oxybenzone CREAM TOPICAL 20171230 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC OCTINOXATE; OCTISALATE; OXYBENZONE 7.5; 5; 3 g/100g; g/100g; g/100g N 20181231 70605-043_9bfd662c-ca1c-446b-8826-dc9377775e95 70605-043 HUMAN OTC DRUG Meaningful Beauty Cindy Crawford Environmental Protecting Moisturizer Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, and OXYBENZONE CREAM TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part352 Guthy-Renker LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE 3; 10; 5; 5 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 70605-055_b29e3aa4-6154-4d2e-be56-4210b649db37 70605-055 HUMAN OTC DRUG Lumipearl Dark Mark Corrector Hydroquinone CREAM TOPICAL 20171230 OTC MONOGRAPH NOT FINAL part358A Guthy-Renker LLC HYDROQUINONE 2 mg/100mL N 20181231 70606-107_30008cdc-f0bc-4cab-9875-be48e57075f7 70606-107 HUMAN OTC DRUG Dr. Greengoods Lice Killer LICE TREATMENT Lecithin SPRAY TOPICAL 20160707 UNAPPROVED HOMEOPATHIC Applied Science Labs, Inc. EGG PHOSPHOLIPIDS 1 [hp_X]/mL E 20171231 70608-001_33af9350-95e4-384e-e054-00144ff88e88 70608-001 HUMAN OTC DRUG Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And Primer ZINC OXIDE CREAM TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part352 Kypris Beauty LLC ZINC OXIDE 200 mg/mL N 20181231 70610-101_5c85ceed-d08b-4ef0-ac48-d65ca5cdd387 70610-101 HUMAN OTC DRUG Greenfish, Cleaning-S POTASSIUM CARBONATE LIQUID TOPICAL 20160328 UNAPPROVED DRUG OTHER KOTUKU INC. POTASSIUM CARBONATE .001 1/450mL E 20171231 70610-102_810ec626-d2d7-4acd-a80e-168a9bbc44e1 70610-102 HUMAN OTC DRUG Greenfish, Body-S POTASSIUM CARBONATE LIQUID TOPICAL 20160407 UNAPPROVED DRUG OTHER KOTUKU INC. POTASSIUM CARBONATE .001 1/80mL E 20171231 70610-103_a5f92c79-9965-4461-87b2-3e48826552ca 70610-103 HUMAN OTC DRUG Greenfish, Food-S POTASSIUM CARBONATE LIQUID TOPICAL 20160418 UNAPPROVED DRUG OTHER KOTUKU INC. POTASSIUM CARBONATE .001 1/450mL E 20171231 70611-001_2fd24cc7-5006-1117-e054-00144ff88e88 70611-001 HUMAN OTC DRUG TROPICAL PINEAPPLE JUMBO LIP BALM OXYBENZONE, OCTINOXATE, HOMOSALATE LIPSTICK TOPICAL 20160406 OTC MONOGRAPH NOT FINAL part352 Yoyo Lip Gloss Inc. OXYBENZONE; OCTINOXATE; HOMOSALATE 10; 10; 10 g/100g; g/100g; g/100g E 20171231 70611-002_302debaf-0b8f-650a-e054-00144ff8d46c 70611-002 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160411 OTC MONOGRAPH NOT FINAL part333E Yoyo Lip Gloss Inc. ALCOHOL 77 mL/100mL N 20181231 70611-002_30c11612-d036-4e5b-e054-00144ff88e88 70611-002 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160411 OTC MONOGRAPH NOT FINAL part333E Yoyo Lip Gloss Inc. ALCOHOL 77 mL/100mL N 20181231 70611-002_3200d8f3-abcb-0db3-e054-00144ff88e88 70611-002 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part333E Yoyo Lip Gloss Inc. ALCOHOL 77 mL/100mL N 20181231 70611-002_3201bcd9-0188-0fba-e054-00144ff8d46c 70611-002 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160504 OTC MONOGRAPH NOT FINAL part333E Yoyo Lip Gloss Inc. ALCOHOL 77 mL/100mL N 20181231 70611-003_37f149ee-0357-6b66-e054-00144ff88e88 70611-003 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160718 OTC MONOGRAPH NOT FINAL part333E Yoyo Lip Gloss Inc. ALCOHOL 63 mL/100mL N 20181231 70611-003_37f16545-4bc0-4cd7-e054-00144ff8d46c 70611-003 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160718 OTC MONOGRAPH NOT FINAL part333E Yoyo Lip Gloss Inc. ALCOHOL 63 mL/100mL N 20181231 70611-003_37f1a9b2-eb6a-6b64-e054-00144ff88e88 70611-003 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160718 OTC MONOGRAPH NOT FINAL part333E Yoyo Lip Gloss Inc. ALCOHOL 63 mL/100mL N 20181231 70611-004_3a681ffc-df41-3df1-e054-00144ff8d46c 70611-004 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160819 OTC MONOGRAPH NOT FINAL part333E Yoyo Lip Gloss Inc. ALCOHOL 77 mL/100mL N 20181231 70612-010_3a3614d6-ca20-4556-b768-6e1598e6aa0b 70612-010 HUMAN OTC DRUG BIOCOOL Tube Type Menthol GEL TOPICAL 20160302 OTC MONOGRAPH NOT FINAL part348 JJindustry.Co.Ltd MENTHOL 4 g/100mL N 20181231 70612-020_e42f8396-a01b-4156-9134-96245cbffa05 70612-020 HUMAN OTC DRUG BIOCOOL ROLL TYPE Menthol GEL TOPICAL 20160302 OTC MONOGRAPH NOT FINAL part348 JJindustry.Co.Ltd MENTHOL 4 g/100mL N 20181231 70616-743_6361da95-6817-4936-a15e-b42f0bcd5dc4 70616-743 HUMAN OTC DRUG Hand Wash Benzalkonium chloride LIQUID TOPICAL 20160512 OTC MONOGRAPH NOT FINAL part333A Permatex BENZALKONIUM CHLORIDE 1.3091 mg/mL N 20181231 70617-305_f3eb4956-ab84-42a6-bcbc-c706036043f1 70617-305 HUMAN OTC DRUG THE GREEN SCISSOR 99 PERCENT ISOPROPYL ALCOHOL LIQUID TOPICAL 20160403 OTC MONOGRAPH NOT FINAL part333A WHOLESALE HARVEST SUPPLY INC ISOPROPYL ALCOHOL 99 mL/100mL E 20171231 70618-001_3deec6f6-5cbd-4d7d-984d-71ba2f6fcc30 70618-001 HUMAN OTC DRUG Be Beautiful Luminous CC Cream OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20160408 OTC MONOGRAPH NOT FINAL part352 THANK YOU FARMER CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 2.4; 1.89; 1.2 mg/40mL; g/40mL; g/40mL N 20181231 70618-002_5cfac641-07ac-5aaf-e053-2991aa0ae848 70618-002 HUMAN OTC DRUG Be Beautiful Natural BB Cream TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20160408 OTC MONOGRAPH NOT FINAL part352 THANK YOU FARMER CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 2.56; 2.4; .8; .77 mg/40mL; mg/40mL; mg/40mL; mg/40mL N 20181231 70618-003_5cfac641-07b6-5aaf-e053-2991aa0ae848 70618-003 HUMAN OTC DRUG Be Beautiful Makeup Base OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20160408 OTC MONOGRAPH NOT FINAL part352 THANK YOU FARMER CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE 2.4; 1.61; .8; .77 mg/40mL; mg/40mL; mg/40mL; mg/40mL N 20181231 70618-004_5cfadc1b-53a9-d7c7-e053-2a91aa0ad45d 70618-004 HUMAN OTC DRUG Sun Project Shimmer Sun Essence OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20160408 OTC MONOGRAPH NOT FINAL part352 THANK YOU FARMER CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 2.4; 1.2; .49 mg/40mL; mg/40mL; mg/40mL N 20181231 70618-005_5cfadc1b-5411-d7c7-e053-2a91aa0ad45d 70618-005 HUMAN OTC DRUG Sun Project Light Sun Essence OCTINOXATE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20160408 OTC MONOGRAPH NOT FINAL part352 THANK YOU FARMER CO., LTD. OCTINOXATE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 2.72; 2.4; 1; .49 mg/40mL; mg/40mL; mg/40mL; mg/40mL N 20181231 70618-006_5cfadc1b-541b-d7c7-e053-2a91aa0ad45d 70618-006 HUMAN OTC DRUG Sun Project Water Sun Cream SPF50 OCTINOXATE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE CREAM TOPICAL 20160408 OTC MONOGRAPH NOT FINAL part352 THANK YOU FARMER CO., LTD. OCTINOXATE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 3.4; 3; 2.25; 1.25; .7 mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20181231 70619-010_365b21dd-d803-463a-b0dc-f8fd81e0bb5d 70619-010 HUMAN OTC DRUG BR Waterfull BB BLEMISH BALM BRIGHT Titanium Dioxide, Octinoxate CREAM TOPICAL 20160302 OTC MONOGRAPH NOT FINAL part352 BR TITANIUM DIOXIDE; OCTINOXATE 2.8; .6 g/40g; g/40g N 20181231 70619-020_e1c04610-b179-4238-ab2c-3a9cf5f9f8dc 70619-020 HUMAN OTC DRUG BR Waterfull BB BLEMISH BALM NATURAL Titanium Dioxide, Octinoxate CREAM TOPICAL 20160302 OTC MONOGRAPH NOT FINAL part352 BR TITANIUM DIOXIDE; OCTINOXATE 2.8; .6 g/40g; g/40g N 20181231 70621-101_06c09242-ddf3-4ea2-b2e2-e7a6ca753df3 70621-101 HUMAN PRESCRIPTION DRUG AMELUZ aminolevulinic acid hydrochloride GEL TOPICAL 20160826 NDA NDA208081 Biofrontera Inc. AMINOLEVULINIC ACID HYDROCHLORIDE 100 mg/g Porphyrin Precursor [EPC],Porphyrinogens [Chemical/Ingredient] N 20181231 70624-001_60c724f5-dc42-9ff7-e053-2991aa0a9d32 70624-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20160301 UNAPPROVED MEDICAL GAS Mobile Oxygen Services Inc OXYGEN 99 L/100L N 20181231 70626-101_045527bc-6644-4b47-a412-4d8173499955 70626-101 HUMAN OTC DRUG SO TOTALLY CLEAN ANTI-BLEMISH PADS SALICYLIC ACID LIQUID TOPICAL 20160502 OTC MONOGRAPH FINAL part333D ASPIRE BRANDS INC SALICYLIC ACID 20 mg/1 N 20181231 70626-103_8bc3d860-3453-48b6-9777-b3e77ba2332a 70626-103 HUMAN OTC DRUG RESCUE ME ACNE BLEMISH TREATMENT ORIGINAL FORMULA SALICYLIC ACID GEL TOPICAL 20170517 OTC MONOGRAPH FINAL part333D ASPIRE BRANDS INC SALICYLIC ACID 2 g/100mL N 20181231 70626-104_87219bb1-f46a-4ff8-af80-863bba6c6933 70626-104 HUMAN OTC DRUG SO TOTALLY CLEAN DEEP PORE CLEANSER SALICYLIC ACID LIQUID TOPICAL 20160502 OTC MONOGRAPH FINAL part333D ASPIRE BRANDS INC SALICYLIC ACID .5 g/100mL N 20181231 70626-201_0fd4cca9-e95b-4253-86f9-aceb0b494e48 70626-201 HUMAN OTC DRUG PICTURE PERFECT DAY DAILY MOISTURIZER AVOBENZONE, OCTOCRYLENE, OCTISALATE LOTION TOPICAL 20160502 OTC MONOGRAPH FINAL part352 ASPIRE BRANDS INC AVOBENZONE; OCTOCRYLENE; OCTISALATE 2; 6; 3 g/100mL; g/100mL; g/100mL N 20181231 70626-504_eb27e144-7e8b-4b84-9322-ca1281021130 70626-504 HUMAN OTC DRUG CLEAN GETAWAY BAG SALICYLIC ACID KIT 20170518 OTC MONOGRAPH FINAL part333D ASPIRE BRANDS INC N 20181231 70630-1601_3035a5d8-3f40-33ed-e054-00144ff88e88 70630-1601 HUMAN OTC DRUG Bali Body SPF Tanning and Body Oil Octinoxate, Octocrylene Cream OIL TOPICAL 20160411 OTC MONOGRAPH FINAL part352 Bali Body Pty Ltd OCTOCRYLENE; OCTINOXATE 2.5; 2.5 mg/100mL; mg/100mL N 20181231 70630-1602_304a627f-34c0-1277-e054-00144ff88e88 70630-1602 HUMAN OTC DRUG Bali Body SPF Cacao Tanning Oil Octinoxate, Octocrylene Cream OIL TOPICAL 20160411 OTC MONOGRAPH FINAL part352 Bali Body Pty Ltd OCTOCRYLENE; OCTINOXATE 2.5; 2.5 mg/100mL; mg/100mL N 20181231 70630-1603_3070b408-df08-4273-e054-00144ff8d46c 70630-1603 HUMAN OTC DRUG Watermelon Tanning Oil Octinoxate, Octocrylene Cream OIL TOPICAL 20160411 OTC MONOGRAPH FINAL part352 Bali Body Pty Ltd OCTOCRYLENE; OCTINOXATE 2.5; 2.5 mg/100mL; mg/100mL N 20181231 70630-1604_30edad22-af62-4b32-e054-00144ff8d46c 70630-1604 HUMAN OTC DRUG Moisturizing Sunscreen SPF Zinc Oxide and Titanium Oxide Cream CREAM TOPICAL 20160420 OTC MONOGRAPH FINAL part352 Bali Body Pty Ltd TITANIUM DIOXIDE; ZINC OXIDE 4; 24.6 mg/100mL; mg/100mL N 20181231 70630-1605_34c4850a-28c4-67cd-e054-00144ff8d46c 70630-1605 HUMAN OTC DRUG Bali Body BB Cream SPF 15 Octinoxate, Octocrylene, Ocybenzone, Avobenzone Cream CREAM TOPICAL 20160608 OTC MONOGRAPH FINAL part352 Bali Body Pty Ltd OCTOCRYLENE; OCTINOXATE; OXYBENZONE; AVOBENZONE 2.7; 4; 3; 4 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 70630-1701_5d7a113a-2562-3b94-e053-2a91aa0affa8 70630-1701 HUMAN OTC DRUG Bali Body Coconut Lip Balm SPF 15 Octinoxate, Octocrylene, Ocybenzone, Avobenzone Cream CREAM TOPICAL 20160608 OTC MONOGRAPH FINAL part352 Bali Body Pty Ltd OCTOCRYLENE; HOMOSALATE; OCTISALATE; AVOBENZONE 2.8; 2.8; 2.8; 2 mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 70631-034_5a20abbf-796c-8a65-e053-2991aa0a0ef3 70631-034 HUMAN OTC DRUG Lavaderm After Sun For Pain and Itching Menthol SPRAY TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part348 Young Living Essential Oils, LC MENTHOL, UNSPECIFIED FORM .005 g/g N 20181231 70635-0001_34e47c88-a0ea-2285-e054-00144ff8d46c 70635-0001 HUMAN OTC DRUG Lutooth Tooth Whitening Kit Carbamide Peroxide GEL, DENTIFRICE DENTAL 20160101 OTC MONOGRAPH NOT FINAL part356 Dent-White Co LTD CARBAMIDE PEROXIDE 8.3 g/100mL N 20181231 70635-0003_34e50510-e3c5-3c6d-e054-00144ff88e88 70635-0003 HUMAN OTC DRUG Lutooth Tooth Whitening Kit Carbamide Peroxide GEL, DENTIFRICE DENTAL 20160101 OTC MONOGRAPH NOT FINAL part356 Dent-White Co LTD CARBAMIDE PEROXIDE 15 g/100mL N 20181231 70637-123_60c70d70-a9fa-7644-e053-2a91aa0a7cf6 70637-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20160301 UNAPPROVED MEDICAL GAS My Oxygen Company, Inc. OXYGEN 99 L/100L N 20181231 70640-101_9b313978-1eda-468a-89fa-9ad35c7fbb1b 70640-101 HUMAN OTC DRUG SUN DMC SPF-30 ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20160413 OTC MONOGRAPH FINAL part352 LET IT BLOCK LLC ZINC OXIDE; TITANIUM DIOXIDE 5; 3 g/100mL; g/100mL E 20171231 70640-102_9e2d1c43-ddb3-49bf-bd5c-a915a39869d8 70640-102 HUMAN OTC DRUG GOTH BLOCK SPF-50 ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20160413 OTC MONOGRAPH FINAL part352 LET IT BLOCK LLC ZINC OXIDE; TITANIUM DIOXIDE 5.5; 11 g/100mL; g/100mL E 20171231 70640-103_78122391-01a1-4764-a1f0-8f6489069dfe 70640-103 HUMAN OTC DRUG LET IT BLOCK SPF-30 ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20160413 OTC MONOGRAPH FINAL part352 LET IT BLOCK LLC ZINC OXIDE; TITANIUM DIOXIDE 5; 3 g/100mL; g/100mL E 20171231 70641-111_463e8172-8235-21b4-e054-00144ff88e88 70641-111 HUMAN OTC DRUG White Girl Sunscreen Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20160606 OTC MONOGRAPH NOT FINAL part352 White Girl, LLC OCTINOXATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE 7; 2.5; 6; 3 g/100g; g/100g; g/100g; g/100g N 20181231 70644-899_29d69d6a-ab70-4222-b06e-2a26a2ca1e85 70644-899 HUMAN PRESCRIPTION DRUG Tobramycin Inhalation Solution Pak Tobramycin SOLUTION RESPIRATORY (INHALATION) 20160711 NDA AUTHORIZED GENERIC NDA205433 Genericus, Inc. TOBRAMYCIN 300 mg/5mL Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient] N 20181231 70645-123_aa8a1fde-7003-46c2-af9c-8289ab50bbc7 70645-123 HUMAN PRESCRIPTION DRUG ZINGO lidocaine hydrochloride monohydrate POWDER INTRADERMAL 20160601 NDA NDA022114 7T Pharma LLC LIDOCAINE HYDROCHLORIDE .5 mg/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 70645-212_83654edc-883f-466e-b627-36e10b96c0fa 70645-212 HUMAN PRESCRIPTION DRUG Ambator Diclofenac Patch DICLOFENAC SODIUM PATCH TOPICAL 20171215 UNAPPROVED DRUG OTHER 7T Pharma LLC DICLOFENAC SODIUM 1 g/10mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70645-415_4097f5b3-f20e-47d9-84c4-883d457fddf6 70645-415 HUMAN PRESCRIPTION DRUG Ambator Lidocaine Patch LIDOCAINE HCL PATCH TOPICAL 20171215 UNAPPROVED DRUG OTHER 7T Pharma LLC LIDOCAINE HYDROCHLORIDE 1 g/10g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 70648-000_5d68363d-bdb9-608b-e053-2991aa0aa85d 70648-000 HUMAN OTC DRUG OLP MUSCLE RUB MENTHOL, UNSPECIFIED FORM GEL TOPICAL 20161016 OTC MONOGRAPH NOT FINAL part348 OHIO LAB PHARMA LLC. MENTHOL, UNSPECIFIED FORM 25 mg/g N 20181231 70648-002_5d67ede3-d6a4-2a02-e053-2a91aa0a15e3 70648-002 HUMAN OTC DRUG OLP Hydrocortisone 1% Hydrocortisone 1% CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part348 OHIO LAB PHARMA HYDROCORTISONE 10 mg/g N 20181231 70648-005_5d67733d-dda5-7bac-e053-2991aa0ae496 70648-005 HUMAN OTC DRUG OLP PAIN-X MENTHOL GEL TOPICAL 20160920 OTC MONOGRAPH NOT FINAL part348 ohio lab pharma MENTHOL, UNSPECIFIED FORM 25 mg/g N 20181231 70648-009_5d67813e-5f40-4bc6-e053-2991aa0ac19d 70648-009 HUMAN OTC DRUG OLP HEMORRHOIDAL COOLING phenylephrine HCL, witch hazel GEL TOPICAL 20170201 OTC MONOGRAPH FINAL part346 OHIO LAB PHARMA PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL 25; 500 mg/g; mg/g N 20181231 70648-103_5d67f484-ff9e-f662-e053-2a91aa0a579c 70648-103 HUMAN OTC DRUG ANTI-ITCH FEMININE CARE HYDROCORTISONE 0.5% CREAM TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part348 OHIO LAB PHARMA HYDROCORTISONE 5 mg/g N 20181231 70648-300_5d67929e-9002-5baa-e053-2a91aa0a71bb 70648-300 HUMAN OTC DRUG OLP ACNE CLEAR SALICYLIC ACID GEL TOPICAL 20170201 OTC MONOGRAPH FINAL part333D OHIO LAB PHARMA SALICYLIC ACID 5 mg/g N 20181231 70648-500_5d67eb89-9c37-e27d-e053-2991aa0af1fd 70648-500 HUMAN OTC DRUG OLP CLOTRIMAZOLE CLOTRIMAZOLE CREAM TOPICAL 20170201 OTC MONOGRAPH FINAL part333C OHIO LAB PHARMA CLOTRIMAZOLE 10 mg/g N 20181231 70651-001_ec78f8ef-25d3-40cd-82ed-32d49570708d 70651-001 HUMAN PRESCRIPTION DRUG Pentetate calcium trisodium pentetate calcium trisodium INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS; RESPIRATORY (INHALATION) 20040811 NDA NDA021749 hameln pharma plus gmbh PENTETATE CALCIUM TRISODIUM 1000 mg/5mL Lead Chelating Activity [MoA],Lead Chelator [EPC] N 20181231 70651-002_c2cb9945-6286-4857-96b0-382ae962b537 70651-002 HUMAN PRESCRIPTION DRUG Pentetate zinc trisodium Pentetate zinc trisodium INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS; RESPIRATORY (INHALATION) 20040811 NDA NDA021751 hameln pharma plus gmbh PENTETATE ZINC TRISODIUM 1000 mg/5mL Lead Chelating Activity [MoA],Lead Chelator [EPC] N 20181231 70652-0001_316f56f2-e853-44b3-e054-00144ff8d46c 70652-0001 HUMAN OTC DRUG Roothouse EnCore Salicylic Acid, Dexpanthenol, L-Menthol SHAMPOO TOPICAL 20160330 UNAPPROVED DRUG OTHER Roothouse SALICYLIC ACID .25 g/100mL E 20171231 70653-010_fcde9f23-1b38-4db4-a53c-f868cbf8f7ff 70653-010 HUMAN OTC DRUG Bling Magic Speedy Brightening Moisturizer Dimethicone CREAM TOPICAL 20160302 OTC MONOGRAPH FINAL part347 GRU INTERNATIONAL DIMETHICONE .15 g/15mL E 20171231 70654-010_6bd2ff51-f4ae-432b-9ca4-8e51a311324b 70654-010 HUMAN OTC DRUG Double S Essence Clean Glycerin GEL TOPICAL 20160401 OTC MONOGRAPH FINAL part347 EINS CORPORATION GLYCERIN 3.75 g/15g N 20181231 70654-020_7198c158-5406-4c48-95ec-281627741ee8 70654-020 HUMAN OTC DRUG Double S Essence Clean 2g 5ea Glycerin GEL TOPICAL 20160401 OTC MONOGRAPH FINAL part347 EINS CORPORATION GLYCERIN .5 g/2g N 20181231 70655-071_b02c8d96-21e1-4d39-8e6e-785c7d26f28e 70655-071 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol INJECTION INTRAMUSCULAR; INTRAVENOUS 20170119 ANDA ANDA208116 Renaissance SSA, LLC METHOCARBAMOL 100 mg/mL Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70656-739_47f4f989-faa6-6576-e054-00144ff8d46c 70656-739 HUMAN OTC DRUG DuSel Psoriasis Dead Sea Salt Therapy SALICYLIC ACID CREAM TOPICAL 20160426 OTC MONOGRAPH FINAL part358H Nanovita One LLC SALICYLIC ACID 20 mg/g N 20181231 70656-740_47f4d4c4-fb0d-5e0e-e054-00144ff8d46c 70656-740 HUMAN OTC DRUG DuSel Psoriasis Dead Sea Salt Therapy SALICYLIC ACID CREAM TOPICAL 20160426 OTC MONOGRAPH FINAL part358H Nanovita One LLC SALICYLIC ACID 20 mg/mL N 20181231 70656-741_48a72afa-7da4-369b-e054-00144ff88e88 70656-741 HUMAN OTC DRUG Dusel Warm Arthritis Dead Sea Salt Therapy CAPSAICIN CREAM TOPICAL 20160426 OTC MONOGRAPH NOT FINAL part348 Nanovita One LLC CAPSAICIN .25 mg/mL N 20181231 70656-742_48a7a01e-3447-45bf-e054-00144ff88e88 70656-742 HUMAN OTC DRUG Dusel Warm Arthritis Dead Sea Salt Therapy CAPSAICIN CREAM TOPICAL 20160426 OTC MONOGRAPH NOT FINAL part348 Nanovita One LLC CAPSAICIN .25 mg/g N 20181231 70656-743_48a72afa-7db3-369b-e054-00144ff88e88 70656-743 HUMAN OTC DRUG Dusel Cool Arthritis Dead Sea Salt Therapy MENTHOL CREAM TOPICAL 20160426 OTC MONOGRAPH NOT FINAL part348 Nanovita One LLC MENTHOL 50 mg/g N 20181231 70656-744_48a7a01e-3454-45bf-e054-00144ff88e88 70656-744 HUMAN OTC DRUG Dusel Cool Arthritis Dead Sea Salt Therapy MENTHOL CREAM TOPICAL 20160426 OTC MONOGRAPH NOT FINAL part348 Nanovita One LLC MENTHOL 50 mg/mL N 20181231 70663-001_3178d496-2d9b-470d-e054-00144ff88e88 70663-001 HUMAN OTC DRUG Hyaluronic Acid Gel Sodium Hyaluronate GEL TOPICAL 20160415 UNAPPROVED DRUG OTHER Meso System S.A. HYALURONATE SODIUM 3.5 mg/mL N 20181231 70663-002_3a347b9a-6e15-269f-e054-00144ff88e88 70663-002 HUMAN OTC DRUG Vitamin C Liquid Allantoin LIQUID TOPICAL 20160816 OTC MONOGRAPH FINAL part347 MESO SYSTEM S A ALLANTOIN .1 mg/mL N 20181231 70663-003_3e26cdbe-a3e0-3ddb-e054-00144ff8d46c 70663-003 HUMAN OTC DRUG Mandelic 2 Peel Gel Allantoin GEL TOPICAL 20161005 OTC MONOGRAPH FINAL part347 MESO SYSTEM S.A. ALLANTOIN .1 mg/mL N 20181231 70663-004_5cff9b67-5bc6-3b99-e053-2991aa0a229e 70663-004 HUMAN OTC DRUG Vitamin C Liquid Allantoin LIQUID TOPICAL 20160816 OTC MONOGRAPH FINAL part347 MESO SYSTEM S A ALLANTOIN .1 mg/mL N 20181231 70663-005_43a6b8e3-49f9-2ac7-e054-00144ff88e88 70663-005 HUMAN OTC DRUG Hyaluronic Acid Gel Sodium Hyaluronate GEL TOPICAL 20161214 UNAPPROVED DRUG OTHER Meso System S.A. HYALURONATE SODIUM 3.5 mg/mL N 20181231 70663-006_43a6a597-51c0-3eec-e054-00144ff8d46c 70663-006 HUMAN OTC DRUG Mandelic 2 Peel Gel Allantoin GEL TOPICAL 20161214 OTC MONOGRAPH FINAL part347 MESO SYSTEM S.A. ALLANTOIN .1 mg/mL N 20181231 70663-007_43e51c3c-adc6-3f98-e054-00144ff88e88 70663-007 HUMAN OTC DRUG Melano Out Cream Allantoin, Glycerin CREAM TOPICAL 20161217 OTC MONOGRAPH FINAL part347 MESO SYSTEM S.A. ALLANTOIN; GLYCERIN .1; .25 mg/mL; mg/mL N 20181231 70663-008_43e51c3c-add3-3f98-e054-00144ff88e88 70663-008 HUMAN OTC DRUG XR CELLULAR MAGIC Sodium Hyaluronate GEL TOPICAL 20161217 UNAPPROVED DRUG OTHER MESO SYSTEM S.A. HYALURONATE SODIUM .1 mg/mL N 20181231 70663-009_43e5ce0a-bfaf-7207-e054-00144ff88e88 70663-009 HUMAN OTC DRUG Hydraface Glycerin, dimethicone CREAM TOPICAL 20161217 OTC MONOGRAPH FINAL part347 MESO SYSTEM S A GLYCERIN; DIMETHICONE 2; .1 mg/mL; mg/mL N 20181231 70663-010_43ec9a62-83f6-722d-e054-00144ff8d46c 70663-010 HUMAN OTC DRUG Melano Out Mask Glycerin, Mineral Oil, Allantoin CREAM TOPICAL 20161218 OTC MONOGRAPH FINAL part347 MESO SYSTEM S.A. GLYCERIN; ALLANTOIN; MINERAL OIL 8; 2; 2 mg/mL; mg/mL; mg/mL N 20181231 70663-012_5d54ecda-b140-7895-e053-2991aa0ad1d5 70663-012 HUMAN OTC DRUG Salicylic 2 Peel Gel Allantoin GEL TOPICAL 20171220 OTC MONOGRAPH FINAL part347 MESO SYSTEM S.A. ALLANTOIN .1 mg/mL N 20181231 70667-745_48a74e28-1c41-61a5-e054-00144ff8d46c 70667-745 HUMAN OTC DRUG bright guard SPF-30 SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20160427 OTC MONOGRAPH NOT FINAL part352 Bright Guard, LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 70667-784_477b067c-e4be-4110-e054-00144ff8d46c 70667-784 HUMAN OTC DRUG Bright Guard Water-Resistant SPF-30 Sunscreen HOMOSALATE,OCTINOXATE,OCTISALATE,AVOBENZONE LOTION TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Bright Guard, LLC HOMOSALATE; OCTINOXATE; OCTISALATE; AVOBENZONE 100; 70; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 70668-746_61844a4e-1113-56c5-e053-2a91aa0a46f4 70668-746 HUMAN OTC DRUG Sunshine on the Go Natural SPF 30plus Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20160427 OTC MONOGRAPH NOT FINAL part352 Products on the Go LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 70668-826_4fa7b7f9-ecec-4d99-e054-00144ff88e88 70668-826 HUMAN OTC DRUG Sunglitter Princess TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170510 OTC MONOGRAPH NOT FINAL part352 Products On The Go, LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 70668-827_4fa7948f-507d-3aa6-e054-00144ff8d46c 70668-827 HUMAN OTC DRUG Natural Diaper Rash ZINC OXIDE CREAM TOPICAL 20170510 OTC MONOGRAPH FINAL part347 Products On The Go, LLC ZINC OXIDE 120 mg/mL N 20181231 70668-828_4fa81cb5-0d92-5a1e-e054-00144ff88e88 70668-828 HUMAN OTC DRUG Natural Blend SPF 30 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170510 OTC MONOGRAPH NOT FINAL part352 Products On The Go, LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 70671-404_ab4fbb0b-9e99-4969-8b3f-a32255c9d4d5 70671-404 HUMAN OTC DRUG HandWorks E2 Foam Hand Cleaner BENZALKONIUM CHLORIDE SOLUTION TOPICAL 20160428 OTC MONOGRAPH NOT FINAL part333A Applied Maintenance Supplies and Solutions BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 70672-123_60c70d70-a9fc-7644-e053-2a91aa0a7cf6 70672-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20160301 UNAPPROVED MEDICAL GAS Dade Medical, Inc. OXYGEN 99 L/100L N 20181231 70673-747_47f5441d-e6e5-0485-e054-00144ff8d46c 70673-747 HUMAN OTC DRUG Smooth Gator Fungus Eliminator CLOTRIMAZOLE LIQUID TOPICAL 20160429 OTC MONOGRAPH FINAL part333C Smooth Gator, LLC CLOTRIMAZOLE 10 mg/mL N 20181231 70674-001_3867d52f-6186-44ad-8292-49514cf6ba93 70674-001 HUMAN OTC DRUG Arnica Ice Cooling CAMPHOR MENTHOL GEL TOPICAL 20160523 OTC MONOGRAPH NOT FINAL part348 Kyron Laboratories (pty) Ltd CAMPHOR (NATURAL); MENTHOL 6; 1 mg/100mg; mg/100mg E 20171231 70675-958_161c6c81-b1ad-4067-ae8f-26c598aee610 70675-958 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20160512 OTC MONOGRAPH NOT FINAL part333A Deqing Jiarou Daily Chemical Co., Ltd ALCOHOL 62 mL/100mL N 20181231 70675-958_2b08f5e6-1286-4242-8ed3-8ea13dc66439 70675-958 HUMAN OTC DRUG HAND SANITIZER ALCOHOL LIQUID TOPICAL 20170116 OTC MONOGRAPH NOT FINAL part333A Deqing Jiarou Daily Chemical Co., Ltd ALCOHOL 62 mL/100mL N 20181231 70677-0002_adbf275b-00f8-4497-93f9-fdbc006f9613 70677-0002 HUMAN OTC DRUG allergy relief Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70677-0003_1f924930-b103-4811-9040-037b3e59089e 70677-0003 HUMAN OTC DRUG allergy relief Diphenhydramine HCl TABLET, COATED ORAL 19900302 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70677-0004_1ed0ec5a-2ca1-480a-94b5-ba6282be9cc5 70677-0004 HUMAN OTC DRUG allergy Chlorpheniramine maleate TABLET ORAL 19921219 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 70677-0005_2e2f3407-aee3-4c9e-adc3-4cf9a810fd0b 70677-0005 HUMAN OTC DRUG nasal decongestant Maximum Strength Pseudoephedrine HCl TABLET ORAL 19810825 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 N 20181231 70677-0006_8e6155da-0742-4840-b15a-4037fc6e3842 70677-0006 HUMAN OTC DRUG all day allergy Cetirizine HCl TABLET ORAL 20150805 ANDA ANDA090760 McKESSON Corporation CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 70677-0007_ab3a5d33-b2bb-4c39-bb97-a8e96bf14de1 70677-0007 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20161012 ANDA ANDA202039 MCKESSON FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20181231 70677-0008_ab3a5d33-b2bb-4c39-bb97-a8e96bf14de1 70677-0008 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20161012 ANDA ANDA202039 MCKESSON FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 70677-0009_a73713d3-5fb8-4d42-80e8-8d8feceb3b8c 70677-0009 HUMAN OTC DRUG Allergy Diphenhydramine Hydrochloride TABLET ORAL 20161125 OTC MONOGRAPH FINAL part341 Mckesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70677-0010_4cc94678-3221-40f1-b068-d133fd59eb5b 70677-0010 HUMAN OTC DRUG Allergy Diphenhydramine Hydrochloride CAPSULE ORAL 20161125 OTC MONOGRAPH FINAL part341 Mckesson DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70677-0011_3fc61a23-87f4-430f-8d08-62e288119c45 70677-0011 HUMAN OTC DRUG DayTime Cold and Flu Acetaminophen,Dextromethorphan,Phenylephrine CAPSULE, LIQUID FILLED ORAL 20161125 OTC MONOGRAPH FINAL part341 Mckesson ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 E 20171231 70677-0012_aa8e63bc-bdf8-4e91-9d13-a6b9a8f52c2d 70677-0012 HUMAN OTC DRUG Chest Congestion Relief Guaifenesin and Dextromethorphan HBr TABLET ORAL 20161125 OTC MONOGRAPH FINAL part341 Mckesson GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 70677-0013_2713bc83-7e9c-4285-afd4-b9456f88b9a7 70677-0013 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20151215 OTC MONOGRAPH FINAL part333B McKesson BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 70677-0014_e2fed582-c378-431f-9cda-b24cb9e6e4e1 70677-0014 HUMAN OTC DRUG Sunmark childrens all day allergy Cetirizine HCl SOLUTION ORAL 20161031 ANDA ANDA204226 Mckesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 70677-0015_5d22032a-252d-45e6-ac03-5b9169e1e876 70677-0015 HUMAN OTC DRUG Sunmark childrens all day allergy Cetirizine HCl SOLUTION ORAL 20161031 ANDA ANDA204226 Mckesson CETIRIZINE HYDROCHLORIDE 5 mg/5mL N 20181231 70677-0016_b493a8e9-98d3-4883-986f-467ead6b6892 70677-0016 HUMAN OTC DRUG sunmark esomeprazole magnesium Esomeprazole CAPSULE, DELAYED RELEASE ORAL 20170924 ANDA ANDA207193 McKesson ESOMEPRAZOLE 20 mg/1 N 20181231 70677-0017_b8b5fcb7-4179-46ff-b28b-2b3af5f062e7 70677-0017 HUMAN OTC DRUG Sunmark pain reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170530 ANDA ANDA075077 McKesson ACETAMINOPHEN 650 mg/1 N 20181231 70677-0018_704bff95-1295-47af-a89e-880223499978 70677-0018 HUMAN OTC DRUG Sunmark Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170526 ANDA ANDA075077 McKesson ACETAMINOPHEN 650 mg/1 N 20181231 70677-0019_2fbbde7b-4e28-4b7a-bd97-e9efeaa228d9 70677-0019 HUMAN OTC DRUG sunmark arthritis pain reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170526 ANDA ANDA075077 Mckesson ACETAMINOPHEN 650 mg/1 N 20181231 70677-0021_241de862-93d6-43e8-b6d7-577385ec1dc9 70677-0021 HUMAN OTC DRUG stay awake caffeine TABLET ORAL 19961121 OTC MONOGRAPH FINAL part340 McKesson (Sunmark) CAFFEINE 200 mg/1 N 20181231 70677-0022_4bc63c99-b039-4e1b-aa95-a4fd6d9feaa3 70677-0022 HUMAN OTC DRUG motion sickness Dimenhydrinate TABLET ORAL 19921201 OTC MONOGRAPH FINAL part336 McKesson (Sunmark) DIMENHYDRINATE 50 mg/1 N 20181231 70677-0024_22836506-2445-4268-9109-5ff69c689d63 70677-0024 HUMAN OTC DRUG nighttime sleep aid diphenydramine HCl TABLET, FILM COATED ORAL 20000610 OTC MONOGRAPH FINAL part338 McKesson (Sunmark) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 70677-0025_76550c2f-c9ce-4711-beb4-8364bdd5d306 70677-0025 HUMAN OTC DRUG Sleep Aid Doxylamine succinate TABLET ORAL 20020411 ANDA ANDA040564 McKesson (Sunmark) DOXYLAMINE SUCCINATE 25 mg/1 N 20181231 70677-0026_aa64ed94-3f97-4b62-ace3-fab6c5612277 70677-0026 HUMAN OTC DRUG motion sickness Meclizine HCl TABLET ORAL 20020624 OTC MONOGRAPH FINAL part336 McKesson (Sunmark) MECLIZINE HYDROCHLORIDE 25 mg/1 N 20181231 70677-0027_71b5e8a9-a2c3-4fab-9706-1a118bd694e1 70677-0027 HUMAN OTC DRUG Stool Softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20170331 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) DOCUSATE CALCIUM 240 mg/1 N 20181231 70677-0028_e1772626-acb5-4db7-8aba-b7349d76aada 70677-0028 HUMAN OTC DRUG Mucus Guaifenesin TABLET, EXTENDED RELEASE ORAL 20171015 NDA NDA021282 MCKESSON CORPORATION GUAIFENESIN 600 mg/1 N 20181231 70677-0029_63d8b221-7446-4bed-a39b-a981040d0c66 70677-0029 HUMAN OTC DRUG SUNMARK CHILDRENS LORATADINE SRP SF GRAPE Loratadine SOLUTION ORAL 20170317 ANDA ANDA076805 McKesson LORATADINE 5 mg/5mL N 20181231 70677-0030_6c857957-47b4-7a25-197b-282884618788 70677-0030 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 20170703 ANDA ANDA074612 McKesson (Sunmark) NICOTINE 7 mg/24h N 20181231 70677-0031_6c857957-47b4-7a25-197b-282884618788 70677-0031 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 20170703 ANDA ANDA074612 McKesson (Sunmark) NICOTINE 14 mg/24h N 20181231 70677-0032_6c857957-47b4-7a25-197b-282884618788 70677-0032 HUMAN OTC DRUG Nicotine Nicotine PATCH TRANSDERMAL 20170703 ANDA ANDA074612 McKesson (Sunmark) NICOTINE 21 mg/24h N 20181231 70677-0034_68a543ab-ec43-4220-abf3-59d8b4bc0cd2 70677-0034 HUMAN OTC DRUG Stool Softener Laxative DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20170831 OTC MONOGRAPH NOT FINAL part334 McKesson (Sunmark) DOCUSATE SODIUM 100 mg/1 N 20181231 70677-0035_e1e810ce-ec1a-4fba-a890-1055e9a8d1fe 70677-0035 HUMAN OTC DRUG sunmark mucus er Guaifenesin TABLET, EXTENDED RELEASE ORAL 20170907 ANDA ANDA091009 McKesson GUAIFENESIN 1200 mg/1 N 20181231 70677-0037_b23a6fc6-1c21-43ca-82ec-73ba3be62d0d 70677-0037 HUMAN OTC DRUG daytime liquid caps Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20150301 OTC MONOGRAPH FINAL part341 McKesson (Sunmark) ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 70678-001_30ec5342-bff8-1ad1-e054-00144ff8d46c 70678-001 HUMAN OTC DRUG COCOSKIN Pramoxine CREAM TOPICAL 20160401 OTC MONOGRAPH FINAL part333B Net Source, LLC PRAMOXINE HYDROCHLORIDE 1.18 mg/mL E 20171231 70680-300_3219237d-b637-030a-e054-00144ff88e88 70680-300 HUMAN OTC DRUG Raw Elements Eco Formula 30 Broad Spectrum SPF 30 ZINC OXIDE CREAM TOPICAL 20160502 OTC MONOGRAPH NOT FINAL part352 Raw Elements LLC ZINC OXIDE 230 mg/mL N 20181231 70680-301_3218f5ea-2209-45c0-e054-00144ff8d46c 70680-301 HUMAN OTC DRUG Raw Elements Lip Rescue 30 Broad Spectrum SPF 30 ZINC OXIDE CREAM TOPICAL 20160503 OTC MONOGRAPH NOT FINAL part352 Raw Elements LLC ZINC OXIDE 227.5 mg/g N 20181231 70680-302_3218f5ea-21f9-45c0-e054-00144ff8d46c 70680-302 HUMAN OTC DRUG Raw Elements Eco 30 Broad Spectrum SPF 30 ZINC OXIDE STICK TOPICAL 20160503 OTC MONOGRAPH NOT FINAL part352 Raw Elements LLC ZINC OXIDE 227.5 mg/g N 20181231 70680-303_3218f5ea-21e9-45c0-e054-00144ff8d46c 70680-303 HUMAN OTC DRUG Raw Elements Tint 30 Broad Spectrum SPF 30 ZINC OXIDE STICK TOPICAL 20160503 OTC MONOGRAPH NOT FINAL part352 Raw Elements LLC ZINC OXIDE 227.5 mg/g N 20181231 70680-304_3218f5ea-2219-45c0-e054-00144ff8d46c 70680-304 HUMAN OTC DRUG Raw Elements Facial Moisturizer Tint Formula 30 SPF 30 Broad Spectrum ZINC OXIDE CREAM TOPICAL 20160503 OTC MONOGRAPH NOT FINAL part352 Raw Elements LLC ZINC OXIDE 230 mg/mL N 20181231 70682-941_a23d0e47-01c6-4bcc-90ef-2365d0fbfc11 70682-941 HUMAN OTC DRUG 357 Super Magnum Caffeine 200mg TABLET, MULTILAYER ORAL 20160519 OTC MONOGRAPH FINAL part340 King Richard Promotions dba DBI CAFFEINE 200 1/1 N 20181231 70683-0703_326b290a-9bd4-468e-e054-00144ff8d46c 70683-0703 HUMAN OTC DRUG Dentisse Sodium Fluoride PASTE, DENTIFRICE DENTAL; ORAL 20140213 OTC MONOGRAPH FINAL part355 Dentisse, Inc. SODIUM FLUORIDE 1.1 mg/g N 20181231 70686-101_277d29fc-0ffc-4a03-a218-e33b3bfa69c8 70686-101 HUMAN OTC DRUG PIXI SUN MIST SPF 30 AMILOXATE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE SPRAY TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part352 PIXI, INC AMILOXATE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 7; 3; 1.9 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 70686-102_6887556b-1e77-4b26-a8bc-649c5fb9aaf8 70686-102 HUMAN OTC DRUG PIXI SUN SERUM SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE CREAM TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part352 PIXI, INC AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE 1; 7.5; 5; 6 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 70687-001_9a833e05-dc34-417e-8e29-667b68f8b24f 70687-001 HUMAN OTC DRUG IM SORRY FOR MY SKIN MASK - BRIGHTENING GLYCERIN CREAM TOPICAL 20160517 OTC MONOGRAPH FINAL part347 IMINELABS GLYCERIN 1.67 mg/33mL E 20171231 70687-002_42ae0327-c0f6-4154-812b-ff25305ceed6 70687-002 HUMAN OTC DRUG IM SORRY FOR MY SKIN MASK - REVITALIZING GLYCERIN CREAM TOPICAL 20160510 OTC MONOGRAPH FINAL part347 IMINELABS GLYCERIN .66 mg/33mL E 20171231 70688-0502_900bb03a-deb5-4522-8dc1-755994b073b6 70688-0502 HUMAN PRESCRIPTION DRUG Kynamro MIPOMERSEN SODIUM INJECTION, SOLUTION SUBCUTANEOUS 20160502 NDA NDA203568 Kastle Therapeutics, LLC MIPOMERSEN SODIUM 200 mg/mL Apolipoprotein B-100 Synthesis Inhibitor [EPC],Decreased Protein Synthesis [PE],Antisense Oligonucleotide [EPC],Oligonucleotides, Antisense [Chemical/Ingredient] N 20181231 70694-0013_601d5f06-b73a-0960-e053-2991aa0a57ab 70694-0013 HUMAN OTC DRUG CLAON (TOOTHPASTE) XYLITOL PASTE, DENTIFRICE DENTAL 20170711 20180711 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) XYLITOL .07 g/100g N 20181231 70694-0090_601d3113-143f-d190-e053-2991aa0aea65 70694-0090 HUMAN OTC DRUG Medi Hydro DP Vita C Ampoule Niacinamide,Adenosine LIQUID TOPICAL 20170815 20180815 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) NIACINAMIDE; ADENOSINE .02; .004 mg/100mL; mg/100mL N 20181231 70694-0645_601a3b70-b582-c48f-e053-2a91aa0ac1b4 70694-0645 HUMAN OTC DRUG CLAON HOCL (500mL) Benzalkonium chloride LIQUID TOPICAL 20170515 20180515 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) BENZALKONIUM CHLORIDE 3 mg/100mL N 20181231 70694-0740_601d6b6f-11bb-1a88-e053-2991aa0ac379 70694-0740 HUMAN OTC DRUG Medi Hydro DP Cream Niacinamide,Adenosine CREAM TOPICAL 20170815 20180815 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) NIACINAMIDE; ADENOSINE .02; .004 g/100g; g/100g N 20181231 70694-0850_601d3113-1430-d190-e053-2991aa0aea65 70694-0850 HUMAN OTC DRUG Medi Hydro DP Stem C Ampoule Niacinamide,Adenosine LIQUID TOPICAL 20170808 20180808 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) NIACINAMIDE; ADENOSINE .02; .001 mg/100mL; mg/100mL N 20181231 70694-1002_601d5f06-b74a-0960-e053-2991aa0a57ab 70694-1002 HUMAN OTC DRUG CLAON ALL 4 CLEANSER NIACINAMIDE LIQUID TOPICAL 20170706 20180706 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) PANTHENOL; NIACINAMIDE .05; .2 mg/100mL; mg/100mL N 20181231 70694-1504_601d6b6f-11d3-1a88-e053-2991aa0ac379 70694-1504 HUMAN OTC DRUG CLAON Soap, Jojoba Oil, Glycerin SOAP TOPICAL 20170815 20180815 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) JOJOBA OIL; GLYCERIN .05; .02 g/100g; g/100g N 20181231 70694-1538_601c38f8-13f1-24cd-e053-2a91aa0ac4ac 70694-1538 HUMAN OTC DRUG Medi Hydro DP Toner Niacinamide,Adenosine LIQUID TOPICAL 20170808 20180808 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) NIACINAMIDE; ADENOSINE .02; .004 mg/100mL; mg/100mL N 20181231 70694-2340_601d10e7-6946-a6c3-e053-2a91aa0a8a51 70694-2340 HUMAN OTC DRUG Medi Hydro DP BB Cream STEARIC ACID,NIACINAMIDE,ALUMINUM HYDROXIDE,ADENOSINE,TITANIUM DIOXIDE CREAM TOPICAL 20170808 20180808 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) STEARIC ACID; NIACINAMIDE; ADENOSINE; TITANIUM DIOXIDE; ALUMINUM HYDROXIDE .05; .02; .00004; .05; .07 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL N 20181231 70694-3687_601ded18-5c14-d5b7-e053-2991aa0ae911 70694-3687 HUMAN OTC DRUG Medi SM 24K Gold Hydrogel Peptide Mask Pack Glycerin,Niacinamide,Chondrus Crispus,Potassium Chloride,Polysorbate 60,Polysorbate 20,Chlorphenesin,Butylene Glycol,Glycyrrhiza glabra,Propolis wax,Xanthan gum,Adenosine,Potassium hydroxide,Titanium dioxide,Gold EMULSION TOPICAL 20171107 20181107 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) POLYSORBATE 20; CHLORPHENESIN; BUTYLENE GLYCOL; GLYCYRRHIZA GLABRA; PROPOLIS WAX; NIACINAMIDE; GLYCERIN; POTASSIUM CHLORIDE; POLYSORBATE 60; CHONDRUS CRISPUS; XANTHAN GUM; ADENOSINE; TITANIUM DIOXIDE; GOLD .01; .01; .01; .01; .01; .02; .05; .02; .02; .02; .01; .01; .01; .01 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70694-3851_601d43c2-e11e-d0a4-e053-2a91aa0a3de5 70694-3851 HUMAN OTC DRUG DISTILPURE MSM Cystine,Cysteine,Methionine,Thiamin,Biotin POWDER TOPICAL 20170916 20180916 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) BIOTIN; CYSTINE; CYSTEINE; METHIONINE; THIAMINE .02; .05; .02; .02; .02 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70694-5370_601d5f06-b72a-0960-e053-2991aa0a57ab 70694-5370 HUMAN OTC DRUG Medi Hydro DP B Tox Ampoule Niacinamide,Adenosine LIQUID TOPICAL 20170808 20180808 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) NIACINAMIDE; ADENOSINE .02; .004 mg/100mL; mg/100mL N 20181231 70694-6641_601ded18-5c24-d5b7-e053-2991aa0ae911 70694-6641 HUMAN OTC DRUG Medi Sun Soothing Aloe vera leaf,Green tea leaf CREAM TOPICAL 20171211 20181220 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) ALOE VERA LEAF; GREEN TEA LEAF .15; .15 mg/100mL; mg/100mL N 20181231 70694-7160_601d3113-141f-d190-e053-2991aa0aea65 70694-7160 HUMAN OTC DRUG Medi Hydro DP Emulsion Niacinamide,Adenosine LIQUID TOPICAL 20170808 20180808 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) ADENOSINE; NIACINAMIDE .004; .02 mg/100mL; mg/100mL N 20181231 70694-7502_645811fb-f758-81c5-e053-2991aa0a279a 70694-7502 HUMAN OTC DRUG M-Frumax22 Asorbic Acid TABLET, CHEWABLE ORAL 20180202 20190202 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) PARASORBIC ACID .086 g/100g N 20191231 70694-7503_645c888f-deb8-94e2-e053-2a91aa0aa893 70694-7503 HUMAN OTC DRUG M-Vegmax22 Vitamin E, d-alpha tocopheryl succinate TABLET, CHEWABLE ORAL 20180202 20190202 UNAPPROVED DRUG OTHER MBG Inc (Korea Institute of Science Development) .ALPHA.-TOCOPHEROL SUCCINATE, D- .033 g/100g N 20191231 70698-001_85f844e6-12a0-47d6-863c-12b4941e5827 70698-001 HUMAN OTC DRUG SPF 30 Broad Spectrum Suncreen Epione Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160502 OTC MONOGRAPH FINAL part352 Epione Medical Corporation TITANIUM DIOXIDE; ZINC OXIDE 5; 10 g/100mL; g/100mL N 20181231 70698-002_c3387d32-2dbd-4a8e-9251-40886d88e170 70698-002 HUMAN OTC DRUG Restoration Serum Epione Hydroquinone CREAM TOPICAL 20170523 OTC MONOGRAPH NOT FINAL part358A Epione Medical Corporation HYDROQUINONE 2 g/100mL N 20181231 70700-262_d9deacd0-2d4e-a9d4-b303-c401c9fde166 70700-262 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20170419 ANDA ANDA203203 Xiromed LLC LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 70700-263_d9deacd0-2d4e-a9d4-b303-c401c9fde166 70700-263 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20170419 ANDA ANDA203203 Xiromed LLC LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 70704-212_5cf14886-80c2-684c-e053-2991aa0a389f 70704-212 HUMAN OTC DRUG Burn Solution Cream Tetracaine cream CREAM TOPICAL 20160823 OTC MONOGRAPH NOT FINAL part348 Burn Solution Foundations TETRACAINE 10 mg/mL N 20181231 70706-1002_62c720f0-d5cb-5c1e-e053-2991aa0a9527 70706-1002 HUMAN OTC DRUG Solmeet Rosin POWDER, DENTIFRICE DENTAL 20160512 UNAPPROVED DRUG OTHER SOLM Co., Ltd. ROSIN .332 1/100g N 20191231 70706-1003_62c722ef-0861-4e8a-e053-2991aa0afcff 70706-1003 HUMAN OTC DRUG UNIWELL 8575 SALT Rosin POWDER, DENTIFRICE DENTAL 20160512 UNAPPROVED DRUG OTHER SOLM Co., Ltd. ROSIN .332 1/100g N 20191231 70706-1004_62c720f0-d5c1-5c1e-e053-2991aa0a9527 70706-1004 HUMAN OTC DRUG Solmeet CALCIUM CARBONATE PASTE, DENTIFRICE DENTAL 20160512 UNAPPROVED DRUG OTHER SOLM Co., Ltd. CALCIUM CARBONATE 15.85 g/100g N 20191231 70707-101_454983d2-4b01-6268-e054-00144ff8d46c 70707-101 HUMAN OTC DRUG Acne Face and Body BENZOYL PEROXIDE SHAMPOO, SUSPENSION TOPICAL 20161230 OTC MONOGRAPH FINAL part333D Face Reality Skin Care, LLC BENZOYL PEROXIDE 25 mg/mL N 20181231 70707-101_45740af0-ec6d-209a-e054-00144ff88e88 70707-101 HUMAN OTC DRUG Acne Face and Body Scrub 2.5% Benzoyl Peroxide SHAMPOO, SUSPENSION TOPICAL 20110915 OTC MONOGRAPH FINAL part333D Face Reality Skin Care, LLC BENZOYL PEROXIDE .025 g/g N 20181231 70707-200_61684d37-22f5-0d1f-e053-2a91aa0a6b20 70707-200 HUMAN OTC DRUG Acne Med BENZOYL PEROXIDE GEL TOPICAL 20161230 OTC MONOGRAPH FINAL part333D Face Reality Skin Care, Llc BENZOYL PEROXIDE 25 mg/mL N 20181231 70707-211_6168726a-2bf6-458f-e053-2991aa0a561c 70707-211 HUMAN OTC DRUG Acne Med BENZOYL PEROXIDE GEL TOPICAL 20161230 OTC MONOGRAPH FINAL part333D Face Reality Skin Care, Llc BENZOYL PEROXIDE 25 mg/mL N 20181231 70707-212_6168726a-2c05-458f-e053-2991aa0a561c 70707-212 HUMAN OTC DRUG Acne Med BENZOYL PEROXIDE GEL TOPICAL 20161230 OTC MONOGRAPH FINAL part333D Face Reality Skin Care, Llc BENZOYL PEROXIDE 25 mg/mL N 20181231 70707-711_454983d2-4aed-6268-e054-00144ff8d46c 70707-711 HUMAN OTC DRUG Acne Face and Body Wash BENZOYL PEROXIDE SHAMPOO, SUSPENSION TOPICAL 20161231 OTC MONOGRAPH FINAL part333D Face Reality Skin Care, LLC BENZOYL PEROXIDE 25 mg/mL N 20181231 70708-786_324d7d0c-4267-5574-e054-00144ff8d46c 70708-786 HUMAN OTC DRUG YETI POT- SCHNOZ WASH NASAL CLEANING SALT GRANULE, FOR SOLUTION NASAL 20160501 UNAPPROVED DRUG OTHER HEALTHLAND LLC SODIUM BICARBONATE; SODIUM CHLORIDE 515; 1685 mg/mg; mg/mg E 20171231 70709-000_759533f6-e30f-4b1d-a17f-9d0f681d671c 70709-000 HUMAN PRESCRIPTION DRUG NITYR Nitisinone TABLET ORAL 20170726 NDA NDA209449 Cycle Pharmaceuticals Ltd. NITISINONE 10 mg/1 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 70709-002_759533f6-e30f-4b1d-a17f-9d0f681d671c 70709-002 HUMAN PRESCRIPTION DRUG NITYR Nitisinone TABLET ORAL 20170726 NDA NDA209449 Cycle Pharmaceuticals Ltd. NITISINONE 2 mg/1 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 70709-005_759533f6-e30f-4b1d-a17f-9d0f681d671c 70709-005 HUMAN PRESCRIPTION DRUG NITYR Nitisinone TABLET ORAL 20170726 NDA NDA209449 Cycle Pharmaceuticals Ltd. NITISINONE 5 mg/1 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 70710-1008_97e3dc96-b2ed-41f5-ba65-124febe5349d 70710-1008 HUMAN PRESCRIPTION DRUG OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE ORAL 20170224 ANDA ANDA208578 Zydus Pharmaceuticals (USA) Inc. OSELTAMIVIR PHOSPHATE 30 mg/1 N 20181231 70710-1009_97e3dc96-b2ed-41f5-ba65-124febe5349d 70710-1009 HUMAN PRESCRIPTION DRUG OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE ORAL 20170224 ANDA ANDA208578 Zydus Pharmaceuticals (USA) Inc. OSELTAMIVIR PHOSPHATE 45 mg/1 N 20181231 70710-1010_97e3dc96-b2ed-41f5-ba65-124febe5349d 70710-1010 HUMAN PRESCRIPTION DRUG OSELTAMIVIR PHOSPHATE OSELTAMIVIR PHOSPHATE CAPSULE ORAL 20170224 ANDA ANDA208578 Zydus Pharmaceuticals (USA) Inc. OSELTAMIVIR PHOSPHATE 75 mg/1 N 20181231 70710-1053_f732e7e8-2486-42d9-9792-ebd37b040d94 70710-1053 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20170815 ANDA ANDA208970 Zydus Pharmaceuticals (USA) Inc. FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70710-1054_f732e7e8-2486-42d9-9792-ebd37b040d94 70710-1054 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20170815 ANDA ANDA208970 Zydus Pharmaceuticals (USA) Inc. FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70710-1063_54edc749-372f-497a-80da-0be7b37f2f9a 70710-1063 HUMAN PRESCRIPTION DRUG Pindolol Pindolol TABLET ORAL 20171107 ANDA ANDA209866 Zydus Pharmaceuticals (USA) Inc. PINDOLOL 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70710-1064_54edc749-372f-497a-80da-0be7b37f2f9a 70710-1064 HUMAN PRESCRIPTION DRUG Pindolol Pindolol TABLET ORAL 20171107 ANDA ANDA209866 Zydus Pharmaceuticals (USA) Inc. PINDOLOL 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70710-1072_3cf01722-3fed-4829-a95f-3822782b6d8d 70710-1072 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20180104 ANDA ANDA209966 Zydus Pharmaceuticals (USA) Inc. MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 70710-1073_3cf01722-3fed-4829-a95f-3822782b6d8d 70710-1073 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20180104 ANDA ANDA209966 Zydus Pharmaceuticals (USA) Inc. MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 70710-1110_62391eed-a284-4c9c-90db-8e1ddb28b3ff 70710-1110 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20170720 ANDA ANDA208938 Zydus Pharmaceuticals (USA) Inc. CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 70710-1111_c80b5990-b2a4-41b9-ab7e-581a539321e3 70710-1111 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE ORAL 20170427 ANDA ANDA208622 Zydus Pharmaceuticals (USA) Inc. TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70710-1112_c80b5990-b2a4-41b9-ab7e-581a539321e3 70710-1112 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE ORAL 20170427 ANDA ANDA208622 Zydus Pharmaceuticals (USA) Inc. TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70710-1113_c80b5990-b2a4-41b9-ab7e-581a539321e3 70710-1113 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE ORAL 20170427 ANDA ANDA208622 Zydus Pharmaceuticals (USA) Inc. TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70710-1121_2b07fbee-9e24-4d39-ba15-8e631c8678e6 70710-1121 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20180111 ANDA ANDA209582 Zydus Pharmaceuticals (USA) Inc. DOXYCYCLINE 50 mg/1 N 20181231 70710-1122_2b07fbee-9e24-4d39-ba15-8e631c8678e6 70710-1122 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20180111 ANDA ANDA209582 Zydus Pharmaceuticals (USA) Inc. DOXYCYCLINE 75 mg/1 N 20181231 70710-1123_2b07fbee-9e24-4d39-ba15-8e631c8678e6 70710-1123 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20180111 ANDA ANDA209582 Zydus Pharmaceuticals (USA) Inc. DOXYCYCLINE 100 mg/1 N 20181231 70710-1124_2b07fbee-9e24-4d39-ba15-8e631c8678e6 70710-1124 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20180111 ANDA ANDA209582 Zydus Pharmaceuticals (USA) Inc. DOXYCYCLINE 150 mg/1 N 20181231 70710-1137_cf526e6e-4734-43e8-b5bb-39d49aefd13d 70710-1137 HUMAN PRESCRIPTION DRUG fluconazole fluconazole TABLET ORAL 20170406 ANDA ANDA208963 Zydus Pharmaceuticals (USA) Inc. FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 70710-1138_cf526e6e-4734-43e8-b5bb-39d49aefd13d 70710-1138 HUMAN PRESCRIPTION DRUG fluconazole fluconazole TABLET ORAL 20170406 ANDA ANDA208963 Zydus Pharmaceuticals (USA) Inc. FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 70710-1139_cf526e6e-4734-43e8-b5bb-39d49aefd13d 70710-1139 HUMAN PRESCRIPTION DRUG fluconazole fluconazole TABLET ORAL 20170406 ANDA ANDA208963 Zydus Pharmaceuticals (USA) Inc. FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 70710-1140_cf526e6e-4734-43e8-b5bb-39d49aefd13d 70710-1140 HUMAN PRESCRIPTION DRUG fluconazole fluconazole TABLET ORAL 20170406 ANDA ANDA208963 Zydus Pharmaceuticals (USA) Inc. FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 70710-1165_2ee59c2e-c3c0-4ef8-b6a9-53d1a6c8c69e 70710-1165 HUMAN PRESCRIPTION DRUG Oseltamivir Phosphate Oseltamivir Phosphate FOR SUSPENSION ORAL 20170914 ANDA ANDA209113 Zydus Pharmaceuticals (USA) Inc. OSELTAMIVIR PHOSPHATE 6 mg/mL N 20181231 70710-1225_fe1b1fa1-e5a7-40fe-96e6-9985475bfd89 70710-1225 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20171226 ANDA ANDA210086 Zydus Pharmaceuticals (USA) Inc. AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70710-1226_fe1b1fa1-e5a7-40fe-96e6-9985475bfd89 70710-1226 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20171226 ANDA ANDA210086 Zydus Pharmaceuticals (USA) Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70710-1227_fe1b1fa1-e5a7-40fe-96e6-9985475bfd89 70710-1227 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20171226 ANDA ANDA210086 Zydus Pharmaceuticals (USA) Inc. AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70710-1228_fe1b1fa1-e5a7-40fe-96e6-9985475bfd89 70710-1228 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20171226 ANDA ANDA210086 Zydus Pharmaceuticals (USA) Inc. AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70710-1229_fe1b1fa1-e5a7-40fe-96e6-9985475bfd89 70710-1229 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20171226 ANDA ANDA210086 Zydus Pharmaceuticals (USA) Inc. AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70710-1230_fe1b1fa1-e5a7-40fe-96e6-9985475bfd89 70710-1230 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20171226 ANDA ANDA210086 Zydus Pharmaceuticals (USA) Inc. AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70710-1327_2bf278f1-020b-44e2-b889-09f15b13af6a 70710-1327 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20171228 ANDA ANDA210079 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 70710-1328_2bf278f1-020b-44e2-b889-09f15b13af6a 70710-1328 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20171228 ANDA ANDA210079 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 70710-1329_2bf278f1-020b-44e2-b889-09f15b13af6a 70710-1329 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20171228 ANDA ANDA210079 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 70710-1330_2bf278f1-020b-44e2-b889-09f15b13af6a 70710-1330 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20171228 ANDA ANDA210079 Zydus Pharmaceuticals (USA) Inc. OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 70710-1417_2c518063-d729-4d61-ba7b-9f04c5e19c93 70710-1417 HUMAN PRESCRIPTION DRUG clopidogrel clopidogrel TABLET, FILM COATED ORAL 20170208 ANDA ANDA201686 Zydus Pharmaceuticals (USA) Inc. CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 70712-101_0c47d981-af90-49b4-920b-d848e1dfdd80 70712-101 HUMAN OTC DRUG ADVANCED PROTECTION SUNSCREEN SPF-30 OCTINOXATE, OCTISALATE, ZINC OXIDE LOTION TOPICAL 20170807 OTC MONOGRAPH NOT FINAL part352 BOTANICAL SCIENCE, INC. OCTINOXATE; OCTISALATE; ZINC OXIDE 7.5; 5; 7 1/100mL; 1/100mL; 1/100mL N 20181231 70718-001_3a5836df-a5e7-2ed1-e054-00144ff88e88 70718-001 HUMAN OTC DRUG Alcohol Swab Isopropyl Alcohol SWAB TOPICAL 20160818 OTC MONOGRAPH FINAL part344 YANTAI DAIMYUNG BABYCARE SUPPLIES CO.,LTD. ISOPROPYL ALCOHOL .7 mL/1 E 20171231 70719-0001_9b938f6b-f052-4abb-aa38-374f3123ba45 70719-0001 HUMAN OTC DRUG Heilen Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Cerebrum Suis, Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), AACG-A, AACG-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto (3-Acetyl-7-Oxo-Dehydroepiandrosterone), Adenosinum Triphosphoricum Dinatrum, Glucagon, Insulinum (Suis), Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20160621 20210707 UNAPPROVED HOMEOPATHIC Heilen CYNANCHUM VINCETOXICUM ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; SUS SCROFA CEREBRUM; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 70719-0002_66d65d7a-15b1-44c5-9b07-7c54f20dd6f2 70719-0002 HUMAN OTC DRUG Heilen Asclepias Vincetoxicum, Echinacea (Angustifolia), Hypothalamus (Suis), Cerebrum Suis, Hepar Suis, Kidney (Suis), Methylcobalamin, Pancreas Suis, Stomach (Suis), AACG-A, AACG-B, Calcarea Carbonica, Gambogia, Gelsemium Sempervirens, Graphites, Nux Vomica, Phytolacca Decandra, 7-Keto (3-Acetyl-7-Oxo-Dehydroepiandrosterone), Adenosinum Triphosphoricum, Dinatrum, Glucagon, Insulinum (Suis), Sarcolacticum Acidum, Proteus (Vulgaris) LIQUID ORAL 20170328 UNAPPROVED HOMEOPATHIC Heilen VINCETOXICUM HIRUNDINARIA ROOT; ECHINACEA ANGUSTIFOLIA; SUS SCROFA HYPOTHALAMUS; SUS SCROFA CEREBRUM; PORK LIVER; PORK KIDNEY; METHYLCOBALAMIN; SUS SCROFA PANCREAS; SUS SCROFA STOMACH; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL N 20181231 70720-120_dabfe558-c0f1-458c-8a4d-6114eb907296 70720-120 HUMAN PRESCRIPTION DRUG Ergomar Sublingual Ergotamine Tartrate TABLET ORAL 20160920 ANDA ANDA087693 TerSera Therapeutics, LLC ERGOTAMINE TARTRATE 2 mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient] N 20181231 70720-951_921f48c8-1d9d-402a-85c2-6b626133b5e9 70720-951 HUMAN PRESCRIPTION DRUG ZOLADEX goserelin acetate IMPLANT SUBCUTANEOUS 20180126 NDA NDA020578 TerSera Therapeutics LLC GOSERELIN ACETATE 10.8 mg/1 Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] N 20191231 70721-001_fcb79981-1237-4ec9-9452-02209868c87d 70721-001 HUMAN OTC DRUG Defend Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 Mydent International BENZOCAINE 200 mg/g N 20181231 70721-002_dcb06ec2-b3c2-43da-9051-90f0884e33de 70721-002 HUMAN OTC DRUG Defend Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 Mydent International BENZOCAINE 200 mg/g N 20181231 70721-003_03023210-90a3-4c65-a217-80780129c0c0 70721-003 HUMAN OTC DRUG Defend Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 Mydent International BENZOCAINE 200 mg/g N 20181231 70721-004_164448c2-f006-489e-a39d-e042fe386448 70721-004 HUMAN OTC DRUG Defend Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 Mydent International BENZOCAINE 200 mg/g N 20181231 70721-005_a230dc4d-5447-49fa-8d0e-9707cf536b13 70721-005 HUMAN OTC DRUG Defend Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 Mydent International BENZOCAINE 200 mg/g N 20181231 70721-006_7ef82223-69bd-4e7b-b3b4-a6e766fe007d 70721-006 HUMAN OTC DRUG Defend Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 Mydent International BENZOCAINE 200 mg/g N 20181231 70721-007_798ae191-5b9d-4c8f-babd-cc95604e02be 70721-007 HUMAN OTC DRUG Defend Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 Mydent International BENZOCAINE 200 mg/g N 20181231 70721-008_641bc7af-8aca-42a4-a549-3bba5db1f6d3 70721-008 HUMAN OTC DRUG Defend Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 Mydent International BENZOCAINE 200 mg/g N 20181231 70721-009_644a7a09-531b-4758-82aa-2b58064fd2ba 70721-009 HUMAN OTC DRUG Defend Benzocaine GEL DENTAL 20141101 OTC MONOGRAPH NOT FINAL part356 Mydent International BENZOCAINE 200 mg/g N 20181231 70722-203_3da9a721-0ac7-559d-e054-00144ff8d46c 70722-203 HUMAN OTC DRUG Aching Head Rub camphor, menthol OINTMENT TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL) 2.55; 3.09 g/100g; g/100g N 20181231 70722-203_3e29e8c3-5bc5-6727-e054-00144ff8d46c 70722-203 HUMAN OTC DRUG Aching Head Rub Camphor, menthol OINTMENT TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL) 2.55; 3.09 g/100g; g/100g N 20181231 70722-208_3dae4fe0-dd0f-671e-e054-00144ff88e88 70722-208 HUMAN OTC DRUG Ass Kisser Camphor, Menthol CREAM TOPICAL 20160929 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL) 2.86; 1.35 g/100g; g/100g N 20181231 70722-208_3e295cbc-37c8-4e25-e054-00144ff8d46c 70722-208 HUMAN OTC DRUG Ass Kisser Camphor, Menthol CREAM TOPICAL 20160929 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM 1.35; 2.86 g/100g; g/100g N 20181231 70722-216_3dc3549e-9e30-7472-e054-00144ff88e88 70722-216 HUMAN OTC DRUG Asana Kisser Camphor, Menthol CREAM TOPICAL 20160930 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL) 2.86; 1.35 g/100g; g/100g N 20181231 70722-216_3e2a7e28-e11e-1082-e054-00144ff8d46c 70722-216 HUMAN OTC DRUG Asana Kisser Camphor, Menthol CREAM TOPICAL 20160930 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM 1.35; 2.86 g/100g; g/100g N 20181231 70722-229_3dcee02a-711a-1d82-e054-00144ff88e88 70722-229 HUMAN OTC DRUG Vital Vapor Camphor, Menthol OINTMENT TOPICAL 20161002 OTC MONOGRAPH NOT FINAL part348 Little Moon essentials CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM .6; 5.2 g/100g; g/100g N 20181231 70722-229_3dd18577-8c65-66b7-e054-00144ff88e88 70722-229 HUMAN OTC DRUG Vital Vapor Camphor, Menthol OINTMENT TOPICAL 20161002 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL) 5.2; .6 g/100g; g/100g N 20181231 70722-229_3e2a7e28-e168-1082-e054-00144ff8d46c 70722-229 HUMAN OTC DRUG Vital Vapor Camphor, Menthol OINTMENT TOPICAL 20161002 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL) 5.2; .6 g/100g; g/100g N 20181231 70722-232_3dfeb1d0-f814-2eaa-e054-00144ff88e88 70722-232 HUMAN OTC DRUG Dream Cream Camphor, Menthol CREAM TOPICAL 20161004 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM .45; 5 g/100g; g/100g N 20181231 70722-232_3e2765bc-783a-597d-e054-00144ff88e88 70722-232 HUMAN OTC DRUG Dream Cream Camphor, Menthol CREAM TOPICAL 20161005 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM .45; 5 g/100g; g/100g N 20181231 70722-246_3d726fd6-ed06-1c12-e054-00144ff88e88 70722-246 HUMAN OTC DRUG Magical Muscle Oil Camphor, Menthol OIL TOPICAL 20160926 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM 1.95; 3.75 g/100g; g/100g N 20181231 70722-246_3da9b4f5-fb05-5d5f-e054-00144ff8d46c 70722-246 HUMAN OTC DRUG Magical Muscle Oil Camphor, Menthol OIL TOPICAL 20160927 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials MENTHOL; CAMPHOR (NATURAL) 3.75; 1.95 g/100g; g/100g N 20181231 70722-260_3d9aeba4-5c4c-38fb-e054-00144ff88e88 70722-260 HUMAN OTC DRUG Crampy Belly Rub Camphor OIL TOPICAL 20160928 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials CAMPHOR (NATURAL) 1.1 g/100g N 20181231 70722-260_3d9d0307-f58f-3077-e054-00144ff8d46c 70722-260 HUMAN OTC DRUG Crampy Belly Rub Camphor OIL TOPICAL 20160928 OTC MONOGRAPH NOT FINAL part348 Little Moon Essentials CAMPHOR (NATURAL) 1.1 g/100g N 20181231 70724-748_48a71929-e8a3-5972-e054-00144ff8d46c 70724-748 HUMAN OTC DRUG Abee Med MENTHOL, HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20160525 OTC MONOGRAPH NOT FINAL part348 Crossover Telecom Llc MENTHOL; HISTAMINE DIHYDROCHLORIDE 15; .5 mg/g; mg/g N 20181231 70724-844_58ec7226-fd01-5aff-e053-2991aa0a365b 70724-844 HUMAN OTC DRUG SANATIVA DRY SKIN RELIEF PETROLATUM, DIMETHICONE CREAM TOPICAL 20170907 OTC MONOGRAPH FINAL part347 Crossover Telecom, LLC PETROLATUM; DIMETHICONE 300; 30 mg/mL; mg/mL N 20181231 70727-497_2aec3db7-90a4-4a20-95ac-04173e60538c 70727-497 HUMAN PRESCRIPTION DRUG Rhopressa netarsudil SOLUTION/ DROPS OPHTHALMIC; TOPICAL 20171218 NDA NDA208254 Aerie Pharmaceuticals Inc. NETARSUDIL MESYLATE .285 mg/mL N 20181231 70728-104_480d6a8f-ae73-30ec-e054-00144ff8d46c 70728-104 HUMAN OTC DRUG Area Foundy Cover octyl methocycinnamate, titanium dioxide, zinc oxide LOTION TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Flow Fushi Inc ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 56; 200; 2084 mg/20g; mg/20g; mg/20g N 20181231 70728-106_480d9f47-78c9-4d81-e054-00144ff88e88 70728-106 HUMAN OTC DRUG Area Foundy Natural octyl methocycinnamate, titanium dioxide, zinc oxide LOTION TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Flow Fushi Inc ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 76; 450; 2110 mg/20g; mg/20g; mg/20g N 20181231 70728-204_480dda5c-ad50-4f99-e054-00144ff8d46c 70728-204 HUMAN OTC DRUG Ion de Cushion Cover Light Beige ICCLB octyl methocycinnamate, titanium dioxide, zinc oxide LOTION TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Flow Fushi Inc ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 460; 400; 2136 mg/20g; mg/20g; mg/20g N 20181231 70728-206_480dc24e-87f7-55db-e054-00144ff88e88 70728-206 HUMAN OTC DRUG Ion de Cushion Cover Beige ICCB octyl methocycinnamate, titanium dioxide, zinc oxide LOTION TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Flow Fushi Inc ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 460; 400; 2104 mg/20g; mg/20g; mg/20g N 20181231 70728-208_480aa1a7-877d-0cef-e054-00144ff8d46c 70728-208 HUMAN OTC DRUG Ion de Cushion Natural Light Beige ICNLB octyl methocycinnamate, titanium dioxide, zinc oxide LOTION TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Flow Fushi Inc ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 844; 800; 1372 mg/20g; mg/20g; mg/20g N 20181231 70728-210_47e34337-093f-269b-e054-00144ff8d46c 70728-210 HUMAN OTC DRUG Ion de Cushion Natural Beige ICNB octyl methocycinnamate, titanium dioxide, zinc oxide LOTION TOPICAL 20160712 OTC MONOGRAPH FINAL part352 Flow Fushi Inc ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 844; 800; 1344 mg/20g; mg/20g; mg/20g N 20181231 70729-000_d16e6b2d-f6d2-49c0-a5f5-95174554818d 70729-000 HUMAN OTC DRUG Ibuprofen Softgels ibuprofen CAPSULE ORAL 20180201 ANDA ANDA206568 Breeden Brothers, LLC IBUPROFEN 200 mg/1 N 20181231 70729-001_7a5189e5-26f5-4db0-8e35-e2b1255a3467 70729-001 HUMAN OTC DRUG Acetaminophen Caplets Acetaminophen TABLET ORAL 20170501 OTC MONOGRAPH NOT FINAL part343 Breeden Brothers, LLC ACETAMINOPHEN 500 mg/1 N 20181231 70729-002_e7bbd188-5e3e-4f1c-96d8-53f6de4b3120 70729-002 HUMAN OTC DRUG Dye Free Ibuprofen Ibuprofen TABLET ORAL 19990301 ANDA ANDA075139 Breeden Brothers, LLC IBUPROFEN 200 mg/1 N 20181231 70729-003_d8959e17-0c78-4619-90ae-9510e6c9d0e2 70729-003 HUMAN OTC DRUG Naproxen Sodium Caplets Naproxen sodium TABLET ORAL 20170201 ANDA ANDA204872 Breeden Brothers, LLC NAPROXEN SODIUM 220 mg/1 N 20181231 70734-001_4184b2a9-6672-4441-9584-d954a677adc8 70734-001 HUMAN OTC DRUG DEAR KLAIRS Illuminating Supple Blemish Cream Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20171218 OTC MONOGRAPH NOT FINAL part352 WISHCOMPANY INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3; 1.6; .32 mg/40mL; mg/40mL; mg/40mL N 20181231 70734-002_135a57e0-704b-4960-82c3-b22c6e99e8a2 70734-002 HUMAN OTC DRUG Dear Klairs Mochi BB Cushion Pact Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20171218 OTC MONOGRAPH NOT FINAL part352 WISHCOMPANY INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 44; 8 mg/g; mg/g; mg/g N 20181231 70734-003_81446dd7-0169-4b20-acd5-a6298b610e71 70734-003 HUMAN OTC DRUG Dear Klairs Midday Blue Sunlotion Octinoxate, Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20171218 OTC MONOGRAPH NOT FINAL part352 WISHCOMPANY INC. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.75; 2; .5 mg/50mL; mg/50mL; mg/50mL N 20181231 70738-001_f4f07fd9-66f9-400a-bd67-9655cf28952a 70738-001 HUMAN OTC DRUG Lagom Cellus Sun Gel OCTINOXATE, OCTOCRYLENE, OCTISALATE GEL TOPICAL 20180108 OTC MONOGRAPH NOT FINAL part352 SKINMED International Co., Ltd. OCTINOXATE; OCTOCRYLENE; OCTISALATE 3.5; 2.5; 2 mg/50mL; mg/50mL; mg/50mL N 20191231 70738-002_fc1b72b1-14cd-4b71-bc6d-580f5b131ba6 70738-002 HUMAN OTC DRUG Lagom Cellus White Moisture Cream DIMETHICONE CREAM TOPICAL 20171206 OTC MONOGRAPH FINAL part347 SKINMED International Co., Ltd. DIMETHICONE .75 mg/50mL N 20181231 70738-003_862476cf-3f2f-4519-936e-11f27cb80c7a 70738-003 HUMAN OTC DRUG Lagom CF Cushion 10 Titanium Dioxide, Octinoxate, Octisalate CREAM TOPICAL 20171130 OTC MONOGRAPH NOT FINAL part352 SKINMED International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE .1462; .067; .04 g/g; g/g; g/g N 20181231 70738-004_214e33b8-f698-4dfb-a6f4-c6215c922b9d 70738-004 HUMAN OTC DRUG Lagom CF Cushion 20 Titanium Dioxide, Octinoxate, Octisalate CREAM TOPICAL 20171130 OTC MONOGRAPH NOT FINAL part352 SKINMED International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE .1462; .067; .04 g/g; g/g; g/g N 20181231 70738-005_4fbdf1c8-3de7-4cd2-b2b1-b027137de297 70738-005 HUMAN OTC DRUG Lagom CF Cushion 30 Titanium Dioxide, Octinoxate, Octisalate CREAM TOPICAL 20171130 OTC MONOGRAPH NOT FINAL part352 SKINMED International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE .1462; .067; .04 g/g; g/g; g/g N 20181231 70741-003_1c310019-9073-40ff-a16f-22e38b03d0ba 70741-003 HUMAN OTC DRUG Mist Alcohol SPRAY TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 62 mL/100mL N 20181231 70741-003_3a51617b-c484-4f26-9edb-08ecb562f592 70741-003 HUMAN OTC DRUG Mist Alcohol SPRAY TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 62 mL/100mL N 20181231 70741-003_d62d3236-662f-4bbe-a9ab-62e0902a688f 70741-003 HUMAN OTC DRUG Mist Alcohol SPRAY TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 62 mL/100mL N 20181231 70741-003_de5eea73-28c4-4372-9c73-106d5fb4f678 70741-003 HUMAN OTC DRUG Mist Alcohol SPRAY TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 62 mL/100mL N 20181231 70741-003_f0ba7aab-52e8-4da6-9403-f17f61f4b88c 70741-003 HUMAN OTC DRUG Mist Alcohol SPRAY TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 62 mL/100mL N 20181231 70741-003_f86982f2-0398-42d3-b283-843b71c78155 70741-003 HUMAN OTC DRUG Mist Alcohol SPRAY TOPICAL 20160824 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 62 mL/100mL N 20181231 70741-004_1269bfc2-2916-4d64-96d5-a6bde05491e1 70741-004 HUMAN OTC DRUG Hygiene Alcohol SPRAY TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-004_42e01f8d-1c59-4d0d-ab57-d9ff2641c0ec 70741-004 HUMAN OTC DRUG Hygiene Alcohol SPRAY TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-004_785b9d55-d3dd-4fc2-ac4d-4b17e014ea6b 70741-004 HUMAN OTC DRUG Hygiene Alcohol SPRAY TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-004_8f83420a-f7d5-4c46-9c52-0c013f5b3f2e 70741-004 HUMAN OTC DRUG Hygiene Alcohol SPRAY TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-004_d6899d7d-ebce-4afe-b791-6a660c36502c 70741-004 HUMAN OTC DRUG Hygiene Alcohol SPRAY TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-004_e6b4f52f-878f-4ccd-84c5-e78eac23c7e2 70741-004 HUMAN OTC DRUG Hygiene Alcohol SPRAY TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-005_07cc565b-a582-4ece-8fef-ba1cf851f684 70741-005 HUMAN OTC DRUG Body Lotion LOTION TOPICAL 20160907 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 62 mL/100mL N 20181231 70741-005_24c86c84-7fec-4b42-a32e-418a79b813f5 70741-005 HUMAN OTC DRUG Body Lotion LOTION TOPICAL 20160907 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 62 mL/100mL N 20181231 70741-005_7b7ee9f4-bc7b-4f53-b667-1a9711ed2975 70741-005 HUMAN OTC DRUG Body Lotion LOTION TOPICAL 20160907 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 62 mL/100mL N 20181231 70741-005_9b139bd3-37b4-4dfe-b28c-1fc5f00481a2 70741-005 HUMAN OTC DRUG Body Lotion LOTION TOPICAL 20160907 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 62 mL/100mL N 20181231 70741-005_9e9ac9f7-4983-45f1-bc03-9357b09acb37 70741-005 HUMAN OTC DRUG Body Lotion LOTION TOPICAL 20160907 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 62 mL/100mL N 20181231 70741-005_b9d9dd56-d327-484d-a386-2ff8e3762a65 70741-005 HUMAN OTC DRUG Body Lotion LOTION TOPICAL 20160907 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 62 mL/100mL N 20181231 70741-006_244dc452-34e8-418f-ab3e-3f71747d030d 70741-006 HUMAN OTC DRUG Hand Lotion LOTION TOPICAL 20160914 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-006_26bd27f8-7496-4c79-aac7-d79ae9f3f194 70741-006 HUMAN OTC DRUG Hand Lotion LOTION TOPICAL 20160831 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-006_36062b36-697f-4cb1-a5e4-76e9c1ebe806 70741-006 HUMAN OTC DRUG Hand Lotion LOTION TOPICAL 20160914 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-006_4bf3ddb6-f3cb-4bac-b79a-75e57e6579aa 70741-006 HUMAN OTC DRUG Hand Lotion LOTION TOPICAL 20160914 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-006_69507b4b-12b5-48bd-9237-fba9e25bf790 70741-006 HUMAN OTC DRUG Hand Lotion LOTION TOPICAL 20160914 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-006_cf105f7a-fcc1-4bc7-9778-ac5baccb248b 70741-006 HUMAN OTC DRUG Hand Lotion LOTION TOPICAL 20160831 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-007_07f41e05-a117-443f-a25b-8f045c0b4cbe 70741-007 HUMAN OTC DRUG Hand Recovery Alcohol LOTION TOPICAL 20170106 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-007_18484b3f-a5de-4cda-a521-68f3ba57973a 70741-007 HUMAN OTC DRUG Hand Recovery Alcohol LOTION TOPICAL 20170106 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-007_a4714a93-4bf9-4545-97d4-fe3217ed4327 70741-007 HUMAN OTC DRUG Hand Recovery Alcohol LOTION TOPICAL 20170106 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-007_cef4cfb3-428b-4066-aedf-d054fd1c8c41 70741-007 HUMAN OTC DRUG Hand Recovery Alcohol LOTION TOPICAL 20170106 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-007_dc4bbb3a-8337-44ff-a1da-d1a946edf7f7 70741-007 HUMAN OTC DRUG Hand Recovery Alcohol LOTION TOPICAL 20170106 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70741-007_edd07c76-6cf1-4847-8375-6a1786278daa 70741-007 HUMAN OTC DRUG Hand Recovery Alcohol LOTION TOPICAL 20170106 OTC MONOGRAPH NOT FINAL part333A Derma Glove ALCOHOL 70 mL/100mL N 20181231 70742-001_bb7ca186-baad-4d2b-9edb-0b206abfde57 70742-001 HUMAN OTC DRUG EZ ACCESS BENZOCAINE LIQUID TOPICAL 20160615 OTC MONOGRAPH FINAL part348 Product Max Group Inc BENZOCAINE 1417 mg/30mL E 20171231 70742-048_99d902a0-4a3b-4391-9712-578c972b6d34 70742-048 HUMAN OTC DRUG STAY HARD BENZOCAINE GEL TOPICAL 20160615 OTC MONOGRAPH FINAL part348 Product Max Group Inc BENZOCAINE 2833 mg/60mL E 20171231 70742-072_21889d96-e832-468b-8568-69d1839a0c42 70742-072 HUMAN OTC DRUG endless Love FOR MEN BENZOCAINE GEL TOPICAL 20160615 OTC MONOGRAPH FINAL part348 Product Max Group Inc BENZOCAINE 2410 mg/50mL E 20171231 70742-088_08d6435d-dad7-4245-b954-a0a075ef6869 70742-088 HUMAN OTC DRUG Magic STAMINA BENZOCAINE LIQUID TOPICAL 20160615 OTC MONOGRAPH FINAL part348 Product Max Group Inc BENZOCAINE 1417 mg/30mL E 20171231 70742-089_0e144306-e60f-4de8-a6cb-70882bd85db8 70742-089 HUMAN OTC DRUG PROLONG BENZOCAINE GEL TOPICAL 20160615 OTC MONOGRAPH FINAL part348 Product Max Group Inc BENZOCAINE 2833 mg/60mL E 20171231 70742-092_bd0dd8a9-3d50-4b11-bed0-28e5efc99fb7 70742-092 HUMAN OTC DRUG anal GLIDE BENZOCAINE GEL TOPICAL 20160615 OTC MONOGRAPH FINAL part348 Product Max Group Inc BENZOCAINE 2833 mg/60mL E 20171231 70742-360_5e75a407-bad8-fdfc-e053-2a91aa0af957 70742-360 HUMAN OTC DRUG Endless Love For Men BENZOCAINE GEL TOPICAL 20171118 OTC MONOGRAPH FINAL part348 Body Action Products, Inc BENZOCAINE 50 mg/mL N 20181231 70744-516_b5f83006-4dd3-4bad-b163-b8293d27c8e5 70744-516 HUMAN OTC DRUG Biotemper Menthol, Camphor LIQUID TOPICAL 20160701 OTC MONOGRAPH NOT FINAL part348 Biotemper MENTHOL; CAMPHOR (SYNTHETIC) 10; 2 g/100mL; g/100mL E 20171231 70745-749_47f504d5-3eb8-5227-e054-00144ff88e88 70745-749 HUMAN OTC DRUG Nopiate Topical Pain Relief MENTHOL, CAPSAICIN CREAM TOPICAL 20160528 OTC MONOGRAPH NOT FINAL part348 Ezra Laboratories, Llc MENTHOL; CAPSAICIN 50; .275 mg/mL; mg/mL N 20181231 70746-000_3cde6734-8bf5-66e2-e054-00144ff8d46c 70746-000 HUMAN OTC DRUG Emergency First Aid Eyewash Purified Water WATER LIQUID TOPICAL 20160919 OTC MONOGRAPH FINAL part349 Longbow first aid products manufactory WATER .991 mL/mL N 20181231 70746-001_43287217-d092-3229-e054-00144ff88e88 70746-001 HUMAN OTC DRUG Emergency First Aid Eyewash Purified Water WATER LIQUID IRRIGATION 20161207 OTC MONOGRAPH FINAL part349 Longbow First Aid Products Manufactory WATER 999.1 mg/mL N 20181231 70749-010_f4074dbf-58f5-4a42-817e-08f631f67fcb 70749-010 HUMAN OTC DRUG ZNSP Ampoule GLYCERIN SOLUTION TOPICAL 20160501 UNAPPROVED DRUG OTHER Z-TON ES BIO CO., LTD. GLYCERIN .25 g/5mL N 20181231 70749-020_e740a820-0096-4cb2-ab65-68a2ab858c4d 70749-020 HUMAN OTC DRUG ZNSP Repair GLYCERIN CREAM TOPICAL 20160501 UNAPPROVED DRUG OTHER Z-TON ES BIO CO., LTD. GLYCERIN .16 g/8g N 20181231 70753-0201_620a6164-2899-4c0f-abdb-cd30b2f0a3f4 70753-0201 HUMAN OTC DRUG GlySal Clear Acne Treatment Serum Salicylic Acid SOLUTION TOPICAL 20160601 OTC MONOGRAPH FINAL part333D Edge Systems LLC SALICYLIC ACID 15 mg/mL E 20171231 70756-806_b90fb88e-3cd3-4ec7-8f83-6598c78a42bf 70756-806 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20170911 ANDA ANDA205868 Lifestar Pharma LLC. LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 70756-807_b90fb88e-3cd3-4ec7-8f83-6598c78a42bf 70756-807 HUMAN PRESCRIPTION DRUG Lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20170911 ANDA ANDA205868 Lifestar Pharma LLC. LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 70756-811_69a088e1-1309-4def-b5c0-439b0a614fff 70756-811 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide OINTMENT TOPICAL 20170714 ANDA ANDA207741 Lifestar Pharma LLC NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70758-010_40b772dd-cf90-45dc-94fa-617673af916b 70758-010 HUMAN OTC DRUG REPIEL SMART FOOT MASK ULTRA RICH Glycerin PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER THE COSRISE CO.,LTD GLYCERIN .8 g/16mL N 20181231 70758-020_054e73d1-8f50-4cc2-acad-31dab90e87e0 70758-020 HUMAN OTC DRUG REPIEL SMART NAIL PACK MIRACLE BUTTER Glycerin PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER THE COSRISE CO.,LTD GLYCERIN .33 g/3mL N 20181231 70758-030_f9169ab1-a33a-4075-a1eb-c93b1fa52a24 70758-030 HUMAN OTC DRUG REPIEL SMART HAND MASK MILKY MOISTURE Glycerin PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER THE COSRISE CO.,LTD GLYCERIN .56 g/14mL N 20181231 70758-040_a0fc1f5e-2460-4ae2-9a05-43a25a724d2c 70758-040 HUMAN OTC DRUG REPIEL SMART HAIR MASK MAGIC STEAM Dimethicone PATCH TOPICAL 20160501 OTC MONOGRAPH FINAL part347 THE COSRISE CO.,LTD DIMETHICONE .6 g/30mL N 20181231 70758-050_aa4f8bee-ee5d-4e37-9744-05bd7ad0ad73 70758-050 HUMAN OTC DRUG REPIEL SMART FOOT PEELING PERFECT CARE Salicylic Acid PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER THE COSRISE CO.,LTD SALICYLIC ACID .04 g/40mL N 20181231 70758-060_79aad8b8-8d67-49ed-8b4d-e83e36287a39 70758-060 HUMAN OTC DRUG REPIEL TIMELESS AQUA SHOT BIO MASK Glycerin PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER THE COSRISE CO.,LTD GLYCERIN 2 g/25mL N 20181231 70758-070_51d0be02-bda4-4af1-a749-06769f66e0bd 70758-070 HUMAN OTC DRUG REPIEL TIMELESS REDNESS SHOT BIO MASK Glycerin PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER THE COSRISE CO.,LTD GLYCERIN 2 g/25mL N 20181231 70758-080_ad97231e-1f70-45de-b28d-c2bdbb3a1203 70758-080 HUMAN OTC DRUG REPIEL TIMELESS LINE SHOT BIO MASK Glycerin PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER THE COSRISE CO.,LTD GLYCERIN 2 g/25mL N 20181231 70758-090_8129a227-f35f-4e95-9374-a5a83bdaaffd 70758-090 HUMAN OTC DRUG REPIEL TIMELESS MELA SHOT BIO MASK Glycerin PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER THE COSRISE CO.,LTD GLYCERIN 2 g/25mL N 20181231 70758-100_6f8b7f0c-54ba-4544-a97e-30f041ff818d 70758-100 HUMAN OTC DRUG REPIEL PERFECT FIT MASK FIRMING Glycerin PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER THE COSRISE CO.,LTD GLYCERIN 2 g/25mL N 20181231 70758-110_e9d9fcc5-2a2d-44ff-b9b9-3ab3abe0696e 70758-110 HUMAN OTC DRUG REPIEL PERFECT FIT MASK SOOTHING Glycerin PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER THE COSRISE CO.,LTD GLYCERIN 2 g/25mL N 20181231 70758-120_52c1e904-f20a-47ca-a5e3-ae76cd7c9138 70758-120 HUMAN OTC DRUG REPIEL PERFECT FIT MASK MOISTURIZING Glycerin PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER THE COSRISE CO.,LTD GLYCERIN 2 g/25mL N 20181231 70758-130_00943c49-0ce3-40c9-9d53-6f49ed32d4be 70758-130 HUMAN OTC DRUG REPIEL PERFECT FIT MASK LIGHTENING Glycerin PATCH TOPICAL 20160501 UNAPPROVED DRUG OTHER THE COSRISE CO.,LTD GLYCERIN 2 g/25mL N 20181231 70759-0001_35ec093b-60c0-12c9-e054-00144ff88e88 70759-0001 HUMAN OTC DRUG AQUACOOL BLUE 120 MENTHOL GEL TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part348 Pharmanuco MENTHOL 3.2 g/100mL N 20181231 70759-0002_35ec23ab-43aa-1923-e054-00144ff8d46c 70759-0002 HUMAN OTC DRUG AQUACOOL BLUE 500 MENTHOL GEL TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part348 Pharmanuco MENTHOL 3.2 g/100mL N 20181231 70759-0003_35ec23ab-43b7-1923-e054-00144ff8d46c 70759-0003 HUMAN OTC DRUG AQUACOOL BLUE ROLL MENTHOL GEL TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part348 Pharmanuco MENTHOL 3.2 g/100mL N 20181231 70759-0004_39b011f9-01ff-40c3-e054-00144ff88e88 70759-0004 HUMAN OTC DRUG AQUACOOL MENTHOL SPRAY TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part348 Pharmanuco MENTHOL 5 g/100mL N 20181231 70759-0005_35fc9fe5-d765-0848-e054-00144ff8d46c 70759-0005 HUMAN OTC DRUG AQUACOOL RED ROLL MENTHOL LIQUID TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part348 Pharmanuco MENTHOL 3 g/100mL N 20181231 70759-0006_35fc9fe5-d771-0848-e054-00144ff8d46c 70759-0006 HUMAN OTC DRUG AQUACOOL RED 120 MENTHOL GEL TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part348 Pharmanuco MENTHOL 3 g/100mL N 20181231 70759-0007_363dbb18-7e84-0255-e054-00144ff8d46c 70759-0007 HUMAN OTC DRUG AQUACOOL RED 500 MENTHOL GEL TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part348 Pharmanuco MENTHOL 3 g/100mL N 20181231 70759-0008_35ec093b-60d0-12c9-e054-00144ff88e88 70759-0008 HUMAN OTC DRUG AQUACOOL AIR MENTHOL SPRAY TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part348 Pharmanuco MENTHOL 10 g/100mL N 20181231 70759-0009_35fc786c-9b05-697d-e054-00144ff88e88 70759-0009 HUMAN OTC DRUG AQUACOOL SHOWER MENTHOL GEL TOPICAL 20160204 OTC MONOGRAPH NOT FINAL part348 Pharmanuco MENTHOL 2.5 g/100mL N 20181231 70759-0010_60d116e1-d0e9-297a-e053-2a91aa0a1a4c 70759-0010 HUMAN OTC DRUG AQUACOOL MULTI ROLL MENTHOL GEL TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part348 Pharmanuco MENTHOL 3 g/100mL N 20181231 70759-0011_60d16462-e81f-77f2-e053-2a91aa0adae5 70759-0011 HUMAN OTC DRUG AQUACOOL MULTI 120 MENTHOL GEL TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part348 Pharmanuco MENTHOL 3 g/100mL N 20181231 70759-0012_60d16dbe-4dd6-a9f5-e053-2991aa0a4629 70759-0012 HUMAN OTC DRUG AQUACOOL MULTI 500 MENTHOL GEL TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part348 Pharmanuco MENTHOL 3 g/100mL N 20181231 70764-101_9eb41382-34b1-4081-b328-33e21f4a95cf 70764-101 HUMAN OTC DRUG MEDICATED PUMICE WASH BENZOYL PEROXIDE LOTION TOPICAL 20160607 OTC MONOGRAPH FINAL part333D CONTROL CORRECTIVE SKINCARE INC BENZOYL PEROXIDE 2.5 g/100mL N 20181231 70764-102_d5451c47-70a7-4834-8bea-ab80532ce899 70764-102 HUMAN OTC DRUG SALICYLIC WASH SALICYLIC ACID LOTION TOPICAL 20160609 OTC MONOGRAPH FINAL part333D CONTROL CORRECTIVE SKINCARE INC SALICYLIC ACID 2 g/100mL E 20171231 70764-201_14e9618f-b695-47ad-a55a-e9be0ab2ad24 70764-201 HUMAN OTC DRUG BOTANICAL SOOTHING SPF-30 OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20160608 OTC MONOGRAPH FINAL part352 CONTROL CORRECTIVE SKINCARE INC OCTINOXATE; OCTISALATE; ZINC OXIDE 6.9; 3; 4 g/100mL; g/100mL; g/100mL N 20181231 70765-750_47f4f989-fa98-6576-e054-00144ff8d46c 70765-750 HUMAN OTC DRUG do naturals SPF 32 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20160607 OTC MONOGRAPH NOT FINAL part352 Dolphin Organics LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 70766-001_35df9d0a-1f4a-5de8-e054-00144ff8d46c 70766-001 HUMAN OTC DRUG Amerfresh Sodium Fluoride PASTE DENTAL 20160301 OTC MONOGRAPH NOT FINAL part356 Yangzhou SION Commodity Co.,Ltd SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 70766-002_5c6453b0-b6f8-4959-e053-2a91aa0a3eb7 70766-002 HUMAN OTC DRUG Amerfresh Sodium Fluoride PASTE DENTAL 20160301 OTC MONOGRAPH NOT FINAL part356 Yangzhou SION Commodity Co.,Ltd SODIUM FLUORIDE .22 g/100g N 20181231 70766-003_60b8c5bc-4b94-406e-e053-2a91aa0a8c0c 70766-003 HUMAN OTC DRUG Amerfresh Sodium Fluoride PASTE TOPICAL 20160301 OTC MONOGRAPH NOT FINAL part356 Yangzhou SION Commodity Co.,Ltd SODIUM MONOFLUOROPHOSPHATE .22 g/100g N 20181231 70767-010_0f8bbb03-00ff-4581-8a0e-18181c16346a 70767-010 HUMAN OTC DRUG Nosk EX Sleep Menthol LIQUID TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part348 DreamAir Co., MENTHOL .2 g/10mL E 20171231 70768-010_73fef23b-5f3c-4239-aed6-155971e45f7d 70768-010 HUMAN OTC DRUG BLACK CAVIDIOL MASK Allantoin PATCH TOPICAL 20160501 OTC MONOGRAPH FINAL part347 ZEMNA COMPANY CO., Ltd ALLANTOIN .2 g/40g N 20181231 70768-020_a94b3f5e-f2f8-4548-a86d-c899c8b46acb 70768-020 HUMAN OTC DRUG Black Paint Rubar Glycerin GEL TOPICAL 20160601 OTC MONOGRAPH FINAL part347 ZEMNA COMPANY CO., Ltd GLYCERIN 13.5 g/45g N 20181231 70768-030_9c410bb1-2330-46a4-a660-81f2d11c3182 70768-030 HUMAN OTC DRUG Aqua Bab Modeling Mask Glycerin, Niacinamide, Allantoin GEL TOPICAL 20160601 UNAPPROVED DRUG OTHER ZEMNA COMPANY CO., Ltd GLYCERIN; NIACINAMIDE; ALLANTOIN 10; 2.2; .04 g/220g; g/220g; g/220g N 20181231 70769-101_0c8866c0-cb24-42d8-aa3b-e3b52ffc7a17 70769-101 HUMAN OTC DRUG CaineTips BENZOCAINE LIQUID ORAL 20160606 OTC MONOGRAPH NOT FINAL part348 J MORITA USA INC BENZOCAINE 20 g/100mL E 20171231 70771-1004_4a0c7174-ea2d-47cf-b143-f869e0a9f9f1 70771-1004 HUMAN PRESCRIPTION DRUG indomethacin indomethacin CAPSULE ORAL 20160721 ANDA ANDA090403 Cadila Healthcare Limited INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70771-1005_4a0c7174-ea2d-47cf-b143-f869e0a9f9f1 70771-1005 HUMAN PRESCRIPTION DRUG indomethacin indomethacin CAPSULE ORAL 20160721 ANDA ANDA090403 Cadila Healthcare Limited INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70771-1006_6bbf7773-24fb-4e24-8c05-4f0a545fbe7c 70771-1006 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20180111 ANDA ANDA209582 Cadila Healthcare Limited DOXYCYCLINE 50 mg/1 N 20181231 70771-1007_6bbf7773-24fb-4e24-8c05-4f0a545fbe7c 70771-1007 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20180111 ANDA ANDA209582 Cadila Healthcare Limited DOXYCYCLINE 75 mg/1 N 20181231 70771-1008_6bbf7773-24fb-4e24-8c05-4f0a545fbe7c 70771-1008 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20180111 ANDA ANDA209582 Cadila Healthcare Limited DOXYCYCLINE 100 mg/1 N 20181231 70771-1009_6bbf7773-24fb-4e24-8c05-4f0a545fbe7c 70771-1009 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline TABLET, FILM COATED ORAL 20180111 ANDA ANDA209582 Cadila Healthcare Limited DOXYCYCLINE 150 mg/1 N 20181231 70771-1015_45c244f1-ec36-4acb-aa3b-9cb513a49733 70771-1015 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, FILM COATED ORAL 20161027 ANDA ANDA205248 Cadila Healthcare Limited NATEGLINIDE 60 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 70771-1016_45c244f1-ec36-4acb-aa3b-9cb513a49733 70771-1016 HUMAN PRESCRIPTION DRUG Nateglinide Nateglinide TABLET, FILM COATED ORAL 20161027 ANDA ANDA205248 Cadila Healthcare Limited NATEGLINIDE 120 mg/1 Glinide [EPC],Potassium Channel Antagonists [MoA] N 20181231 70771-1019_bd9a8518-51f1-413a-adb0-71eba9928387 70771-1019 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20170810 ANDA ANDA206745 Cadila Healthcare Limited ENTECAVIR .5 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70771-1020_bd9a8518-51f1-413a-adb0-71eba9928387 70771-1020 HUMAN PRESCRIPTION DRUG Entecavir Entecavir TABLET, FILM COATED ORAL 20170810 ANDA ANDA206745 Cadila Healthcare Limited ENTECAVIR 1 mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 70771-1021_dcf8aaba-0099-467e-a342-0b22a7e68de0 70771-1021 HUMAN PRESCRIPTION DRUG pioglitazone pioglitazone TABLET ORAL 20161116 ANDA ANDA202456 Cadila Healthcare Limited PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 70771-1022_dcf8aaba-0099-467e-a342-0b22a7e68de0 70771-1022 HUMAN PRESCRIPTION DRUG pioglitazone pioglitazone TABLET ORAL 20161116 ANDA ANDA202456 Cadila Healthcare Limited PIOGLITAZONE HYDROCHLORIDE 30 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 70771-1023_dcf8aaba-0099-467e-a342-0b22a7e68de0 70771-1023 HUMAN PRESCRIPTION DRUG pioglitazone pioglitazone TABLET ORAL 20161116 ANDA ANDA202456 Cadila Healthcare Limited PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20191231 70771-1030_988969e4-5ff8-411a-9ad2-14e860c4e914 70771-1030 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170928 ANDA ANDA206534 Cadila Healthcare Limited DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70771-1031_988969e4-5ff8-411a-9ad2-14e860c4e914 70771-1031 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170928 ANDA ANDA206534 Cadila Healthcare Limited DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70771-1032_988969e4-5ff8-411a-9ad2-14e860c4e914 70771-1032 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170928 ANDA ANDA206534 Cadila Healthcare Limited DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70771-1033_988969e4-5ff8-411a-9ad2-14e860c4e914 70771-1033 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170928 ANDA ANDA206534 Cadila Healthcare Limited DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70771-1034_988969e4-5ff8-411a-9ad2-14e860c4e914 70771-1034 HUMAN PRESCRIPTION DRUG diltiazem hydrochloride diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20170928 ANDA ANDA206534 Cadila Healthcare Limited DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70771-1035_48ac947f-4a90-4d6d-8b1e-83fae56545c3 70771-1035 HUMAN PRESCRIPTION DRUG TIADYLT ER diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA206641 Cadila Healthcare Limited DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70771-1036_48ac947f-4a90-4d6d-8b1e-83fae56545c3 70771-1036 HUMAN PRESCRIPTION DRUG TIADYLT ER diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA206641 Cadila Healthcare Limited DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70771-1037_48ac947f-4a90-4d6d-8b1e-83fae56545c3 70771-1037 HUMAN PRESCRIPTION DRUG TIADYLT ER diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA206641 Cadila Healthcare Limited DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70771-1038_48ac947f-4a90-4d6d-8b1e-83fae56545c3 70771-1038 HUMAN PRESCRIPTION DRUG TIADYLT ER diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA206641 Cadila Healthcare Limited DILTIAZEM HYDROCHLORIDE 300 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70771-1039_48ac947f-4a90-4d6d-8b1e-83fae56545c3 70771-1039 HUMAN PRESCRIPTION DRUG TIADYLT ER diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA206641 Cadila Healthcare Limited DILTIAZEM HYDROCHLORIDE 360 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70771-1040_48ac947f-4a90-4d6d-8b1e-83fae56545c3 70771-1040 HUMAN PRESCRIPTION DRUG TIADYLT ER diltiazem hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20171108 ANDA ANDA206641 Cadila Healthcare Limited DILTIAZEM HYDROCHLORIDE 420 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70771-1045_fb092797-d6a7-4ecf-bc1f-40abf08156cb 70771-1045 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET ORAL 20170119 ANDA ANDA206560 Cadila Healthcare Limited METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 70771-1046_fb092797-d6a7-4ecf-bc1f-40abf08156cb 70771-1046 HUMAN PRESCRIPTION DRUG METRONIDAZOLE METRONIDAZOLE TABLET ORAL 20170119 ANDA ANDA206560 Cadila Healthcare Limited METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 70771-1051_b5ea9560-7195-403b-85bd-dd17d4467383 70771-1051 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20180104 ANDA ANDA209966 Cadila Healthcare Limited MODAFINIL 100 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 70771-1052_b5ea9560-7195-403b-85bd-dd17d4467383 70771-1052 HUMAN PRESCRIPTION DRUG Modafinil Modafinil TABLET ORAL 20180104 ANDA ANDA209966 Cadila Healthcare Limited MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20181231 70771-1057_7e5f02ce-f964-4059-ae7e-a862e17bfe9e 70771-1057 HUMAN PRESCRIPTION DRUG acamprosate calcium acamprosate calcium TABLET, DELAYED RELEASE ORAL 20170601 ANDA ANDA205995 Cadila Healthcare Limited ACAMPROSATE CALCIUM 333 mg/1 N 20181231 70771-1058_3add9f96-1e15-4c3e-88e0-03948601765e 70771-1058 HUMAN PRESCRIPTION DRUG Methotrexate Methotrexate TABLET ORAL 20170209 ANDA ANDA207812 Cadila Healthcare Limited METHOTREXATE 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 70771-1059_38017893-85e5-44b2-906e-87f78cd4dea0 70771-1059 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA205192 Cadila Healthcare Limited OLMESARTAN MEDOXOMIL 5 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70771-1060_38017893-85e5-44b2-906e-87f78cd4dea0 70771-1060 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA205192 Cadila Healthcare Limited OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70771-1061_38017893-85e5-44b2-906e-87f78cd4dea0 70771-1061 HUMAN PRESCRIPTION DRUG olmesartan medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA205192 Cadila Healthcare Limited OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70771-1062_1d16d60d-ffd3-4f23-a372-d5990ac7d2db 70771-1062 HUMAN PRESCRIPTION DRUG clopidogrel clopidogrel TABLET, FILM COATED ORAL 20170208 ANDA ANDA201686 Cadila Healthcare Limited CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 70771-1063_e606d412-439c-4286-9c2a-39f33f8bd30c 70771-1063 HUMAN PRESCRIPTION DRUG fluconazole fluconazole TABLET ORAL 20170406 ANDA ANDA208963 Cadila Healthcare Limited FLUCONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 70771-1064_e606d412-439c-4286-9c2a-39f33f8bd30c 70771-1064 HUMAN PRESCRIPTION DRUG fluconazole fluconazole TABLET ORAL 20170406 ANDA ANDA208963 Cadila Healthcare Limited FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 70771-1065_e606d412-439c-4286-9c2a-39f33f8bd30c 70771-1065 HUMAN PRESCRIPTION DRUG fluconazole fluconazole TABLET ORAL 20170406 ANDA ANDA208963 Cadila Healthcare Limited FLUCONAZOLE 150 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 70771-1066_e606d412-439c-4286-9c2a-39f33f8bd30c 70771-1066 HUMAN PRESCRIPTION DRUG fluconazole fluconazole TABLET ORAL 20170406 ANDA ANDA208963 Cadila Healthcare Limited FLUCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20191231 70771-1067_37e21893-594f-4b96-83ca-f1103d2e6369 70771-1067 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE ORAL 20170427 ANDA ANDA208622 Cadila Healthcare Limited TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70771-1068_37e21893-594f-4b96-83ca-f1103d2e6369 70771-1068 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE ORAL 20170427 ANDA ANDA208622 Cadila Healthcare Limited TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70771-1069_37e21893-594f-4b96-83ca-f1103d2e6369 70771-1069 HUMAN PRESCRIPTION DRUG tizanidine hydrochloride tizanidine hydrochloride CAPSULE ORAL 20170427 ANDA ANDA208622 Cadila Healthcare Limited TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70771-1070_f2fc77b5-4ac9-469a-b2c2-4ba2c8b05a3b 70771-1070 HUMAN PRESCRIPTION DRUG CHOLESTYRAMINE CHOLESTYRAMINE POWDER, FOR SUSPENSION ORAL 20170608 ANDA ANDA202902 Cadila Healthcare Limited CHOLESTYRAMINE 4 g/5.5g Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA] N 20181231 70771-1071_5a06e666-c9c3-47fa-b83b-265caf8cf8e4 70771-1071 HUMAN PRESCRIPTION DRUG mesalamine mesalamine TABLET, DELAYED RELEASE ORAL 20170619 ANDA ANDA091640 Cadila Healthcare Limited MESALAMINE 1.2 g/1 Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] N 20181231 70771-1072_07c44ac6-7807-480d-ad44-447e3e3a3000 70771-1072 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20170720 ANDA ANDA205798 Cadila Healthcare Limited MIRTAZAPINE 15 mg/1 N 20181231 70771-1073_07c44ac6-7807-480d-ad44-447e3e3a3000 70771-1073 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20170720 ANDA ANDA205798 Cadila Healthcare Limited MIRTAZAPINE 30 mg/1 N 20181231 70771-1074_07c44ac6-7807-480d-ad44-447e3e3a3000 70771-1074 HUMAN PRESCRIPTION DRUG mirtazapine mirtazapine TABLET, ORALLY DISINTEGRATING ORAL 20170720 ANDA ANDA205798 Cadila Healthcare Limited MIRTAZAPINE 45 mg/1 N 20181231 70771-1075_384a4692-076b-4664-a5fb-f9bfd0b6741b 70771-1075 HUMAN PRESCRIPTION DRUG budesonide budesonide CAPSULE, COATED PELLETS ORAL 20170608 ANDA ANDA206134 Cadila Healthcare Limited BUDESONIDE 3 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70771-1076_6565ce65-02ad-47a6-9188-3c6bcee34f18 70771-1076 HUMAN PRESCRIPTION DRUG CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE TABLET ORAL 20170720 ANDA ANDA208938 Cadila Healthcare Limited CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20181231 70771-1077_54e4d1c3-cf8c-4fff-8280-8edcb484c76e 70771-1077 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20170815 ANDA ANDA208970 Cadila Healthcare Limited FELBAMATE 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70771-1078_54e4d1c3-cf8c-4fff-8280-8edcb484c76e 70771-1078 HUMAN PRESCRIPTION DRUG Felbamate Felbamate TABLET ORAL 20170815 ANDA ANDA208970 Cadila Healthcare Limited FELBAMATE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70771-1079_c7747215-0f1a-4ff6-9771-0c3ee67e7913 70771-1079 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin INJECTION, SOLUTION INTRAVENOUS 20170801 ANDA ANDA205968 Cadila Healthcare Limited LEVOFLOXACIN 25 mg/mL N 20181231 70771-1080_50fa82b3-b909-4a6a-a8c3-0dcd6be9a758 70771-1080 HUMAN PRESCRIPTION DRUG clobetasol propionate clobetasol propionate SPRAY TOPICAL 20170712 ANDA ANDA206378 Cadila Healthcare Limited CLOBETASOL PROPIONATE .05 g/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70771-1081_eed2fb08-0ba5-4293-9d0e-d72ee271cc1b 70771-1081 HUMAN PRESCRIPTION DRUG acyclovir ACYCLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170817 ANDA ANDA206606 Cadila Healthcare Limited ACYCLOVIR SODIUM 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 70771-1082_eed2fb08-0ba5-4293-9d0e-d72ee271cc1b 70771-1082 HUMAN PRESCRIPTION DRUG acyclovir ACYCLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170817 ANDA ANDA206606 Cadila Healthcare Limited ACYCLOVIR SODIUM 1000 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 70771-1083_aa36dffd-e56d-43a9-ab2e-c2a6005c8b2b 70771-1083 HUMAN PRESCRIPTION DRUG Diflunisal Diflunisal TABLET ORAL 20170914 ANDA ANDA203547 Cadila Healthcare Limited DIFLUNISAL 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70771-1084_f53d29cf-87b2-49b2-8050-b4a4223a8273 70771-1084 HUMAN PRESCRIPTION DRUG Mycophenolate Mofetil Mycophenolate Mofetil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170922 ANDA ANDA204473 Cadila Healthcare Limited MYCOPHENOLATE MOFETIL 500 mg/20mL Antimetabolite Immunosuppressant [EPC] N 20181231 70771-1085_fc49d140-4b1e-40c0-871b-783cdb0e81fa 70771-1085 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION INTRAVENOUS 20171004 ANDA ANDA205228 Cadila Healthcare Limited TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 70771-1086_1b7e1703-67fb-4d5e-945a-1b6e23861522 70771-1086 HUMAN PRESCRIPTION DRUG oxybutynin oxybutynin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170810 ANDA ANDA202332 Cadila Healthcare Limited OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 70771-1087_1b7e1703-67fb-4d5e-945a-1b6e23861522 70771-1087 HUMAN PRESCRIPTION DRUG oxybutynin oxybutynin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170810 ANDA ANDA202332 Cadila Healthcare Limited OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 70771-1088_1b7e1703-67fb-4d5e-945a-1b6e23861522 70771-1088 HUMAN PRESCRIPTION DRUG oxybutynin oxybutynin TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170810 ANDA ANDA202332 Cadila Healthcare Limited OXYBUTYNIN CHLORIDE 15 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 70771-1089_a8d6ae8b-d94a-46a9-89a8-867e1c9e65a2 70771-1089 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20170808 ANDA ANDA207761 Cadila Healthcare Limited NADOLOL 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70771-1090_a8d6ae8b-d94a-46a9-89a8-867e1c9e65a2 70771-1090 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20170808 ANDA ANDA207761 Cadila Healthcare Limited NADOLOL 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70771-1091_a8d6ae8b-d94a-46a9-89a8-867e1c9e65a2 70771-1091 HUMAN PRESCRIPTION DRUG Nadolol Nadolol TABLET ORAL 20170808 ANDA ANDA207761 Cadila Healthcare Limited NADOLOL 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70771-1092_fb26db15-6b7c-4012-b28c-a9cbfd52abe0 70771-1092 HUMAN PRESCRIPTION DRUG temozolomide temozolomide CAPSULE ORAL 20171026 ANDA ANDA206750 Cadila Healthcare Limited TEMOZOLOMIDE 5 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 70771-1093_fb26db15-6b7c-4012-b28c-a9cbfd52abe0 70771-1093 HUMAN PRESCRIPTION DRUG temozolomide temozolomide CAPSULE ORAL 20171026 ANDA ANDA206750 Cadila Healthcare Limited TEMOZOLOMIDE 20 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 70771-1094_fb26db15-6b7c-4012-b28c-a9cbfd52abe0 70771-1094 HUMAN PRESCRIPTION DRUG temozolomide temozolomide CAPSULE ORAL 20171026 ANDA ANDA206750 Cadila Healthcare Limited TEMOZOLOMIDE 100 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 70771-1095_fb26db15-6b7c-4012-b28c-a9cbfd52abe0 70771-1095 HUMAN PRESCRIPTION DRUG temozolomide temozolomide CAPSULE ORAL 20171026 ANDA ANDA206750 Cadila Healthcare Limited TEMOZOLOMIDE 140 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 70771-1096_fb26db15-6b7c-4012-b28c-a9cbfd52abe0 70771-1096 HUMAN PRESCRIPTION DRUG temozolomide temozolomide CAPSULE ORAL 20171026 ANDA ANDA206750 Cadila Healthcare Limited TEMOZOLOMIDE 180 1/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 70771-1097_fb26db15-6b7c-4012-b28c-a9cbfd52abe0 70771-1097 HUMAN PRESCRIPTION DRUG temozolomide temozolomide CAPSULE ORAL 20171026 ANDA ANDA206750 Cadila Healthcare Limited TEMOZOLOMIDE 250 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 70771-1106_cb822566-2cef-4232-afe6-d42e84d43bd7 70771-1106 HUMAN PRESCRIPTION DRUG Ethacrynate Sodium Ethacrynate Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20180124 ANDA ANDA207758 Cadila Healthcare Limited ETHACRYNATE SODIUM 50 mg/50mL Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70771-1107_8cbfff26-bdf1-425c-a96c-e32c82c0934f 70771-1107 HUMAN PRESCRIPTION DRUG Eletriptan hydrobromide Eletriptan hydrobromide TABLET, FILM COATED ORAL 20170712 ANDA ANDA206409 Cadila Healthcare Limited ELETRIPTAN HYDROBROMIDE 20 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 70771-1108_8cbfff26-bdf1-425c-a96c-e32c82c0934f 70771-1108 HUMAN PRESCRIPTION DRUG Eletriptan hydrobromide Eletriptan hydrobromide TABLET, FILM COATED ORAL 20170712 ANDA ANDA206409 Cadila Healthcare Limited ELETRIPTAN HYDROBROMIDE 40 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 70771-1109_91868a02-7c53-40e3-96e1-75fe16f5e271 70771-1109 HUMAN PRESCRIPTION DRUG ezetimibe ezetimibe TABLET ORAL 20170809 ANDA ANDA204331 Cadila Healthcare Limited EZETIMIBE 10 mg/1 Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] N 20181231 70771-1111_788ab73f-d0ff-4f99-b04b-ef7700abdaa8 70771-1111 HUMAN PRESCRIPTION DRUG Linezolid Linezolid TABLET, FILM COATED ORAL 20170809 ANDA ANDA206097 Cadila Healthcare Limited LINEZOLID 600 mg/1 Oxazolidinone Antibacterial [EPC],Oxazolidinones [Chemical/Ingredient] N 20181231 70771-1112_ffdedf13-4b6d-489c-87e0-2e24385a6295 70771-1112 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20170831 ANDA ANDA208719 Cadila Healthcare Limited DOXAZOSIN MESYLATE 1 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70771-1113_ffdedf13-4b6d-489c-87e0-2e24385a6295 70771-1113 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20170831 ANDA ANDA208719 Cadila Healthcare Limited DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70771-1114_ffdedf13-4b6d-489c-87e0-2e24385a6295 70771-1114 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20170831 ANDA ANDA208719 Cadila Healthcare Limited DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70771-1115_ffdedf13-4b6d-489c-87e0-2e24385a6295 70771-1115 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20170831 ANDA ANDA208719 Cadila Healthcare Limited DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70771-1119_929b9f15-a6b5-44ba-b615-6f26d3600e20 70771-1119 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20170928 ANDA ANDA090961 Cadila Healthcare Limited MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 70771-1120_929b9f15-a6b5-44ba-b615-6f26d3600e20 70771-1120 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET, FILM COATED ORAL 20170928 ANDA ANDA090961 Cadila Healthcare Limited MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 70771-1121_8049ec7f-3874-4527-8688-e3957ba917e8 70771-1121 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20180201 ANDA ANDA207757 Cadila Healthcare Limited DOXYCYCLINE HYCLATE 100 mg/10mL N 20181231 70771-1122_8049ec7f-3874-4527-8688-e3957ba917e8 70771-1122 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20180201 ANDA ANDA207757 Cadila Healthcare Limited DOXYCYCLINE HYCLATE 200 mg/20mL N 20181231 70771-1123_d4460402-1bfe-4301-b07d-04eda802a256 70771-1123 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20171012 ANDA ANDA204221 Cadila Healthcare Limited TELMISARTAN; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70771-1124_d4460402-1bfe-4301-b07d-04eda802a256 70771-1124 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20171012 ANDA ANDA204221 Cadila Healthcare Limited TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70771-1125_d4460402-1bfe-4301-b07d-04eda802a256 70771-1125 HUMAN PRESCRIPTION DRUG Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide TABLET ORAL 20171012 ANDA ANDA204221 Cadila Healthcare Limited TELMISARTAN; HYDROCHLOROTHIAZIDE 80; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 70771-1128_3bef84c2-df2a-4ff2-be54-875cf1016885 70771-1128 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20171211 ANDA ANDA205253 Cadila Healthcare Limited TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 70771-1129_3bef84c2-df2a-4ff2-be54-875cf1016885 70771-1129 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20171211 ANDA ANDA205253 Cadila Healthcare Limited TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 70771-1130_3bef84c2-df2a-4ff2-be54-875cf1016885 70771-1130 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20171211 ANDA ANDA205253 Cadila Healthcare Limited TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 70771-1131_3bef84c2-df2a-4ff2-be54-875cf1016885 70771-1131 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20171211 ANDA ANDA205253 Cadila Healthcare Limited TRAZODONE HYDROCHLORIDE 300 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20181231 70771-1134_d4078b63-30ad-435b-a081-4d90562962b5 70771-1134 HUMAN PRESCRIPTION DRUG Pindolol Pindolol TABLET ORAL 20171107 ANDA ANDA209866 Cadila Healthcare Limited PINDOLOL 5 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70771-1135_d4078b63-30ad-435b-a081-4d90562962b5 70771-1135 HUMAN PRESCRIPTION DRUG Pindolol Pindolol TABLET ORAL 20171107 ANDA ANDA209866 Cadila Healthcare Limited PINDOLOL 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70771-1136_f74cc72d-a7c3-4549-9c2b-a5ce262457b6 70771-1136 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE, GELATIN COATED ORAL 20171117 ANDA ANDA065217 Cadila Healthcare Limited CLINDAMYCIN HYDROCHLORIDE 75 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 70771-1137_f74cc72d-a7c3-4549-9c2b-a5ce262457b6 70771-1137 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE, GELATIN COATED ORAL 20171123 ANDA ANDA065217 Cadila Healthcare Limited CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 70771-1139_1c8f4341-8000-4a4c-8cdd-4643062c117d 70771-1139 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20171202 ANDA ANDA077621 Cadila Healthcare Limited AZATHIOPRINE 25 1/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 70771-1140_1c8f4341-8000-4a4c-8cdd-4643062c117d 70771-1140 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20171202 ANDA ANDA077621 Cadila Healthcare Limited AZATHIOPRINE 75 1/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 70771-1141_1c8f4341-8000-4a4c-8cdd-4643062c117d 70771-1141 HUMAN PRESCRIPTION DRUG Azathioprine Azathioprine TABLET ORAL 20171202 ANDA ANDA077621 Cadila Healthcare Limited AZATHIOPRINE 100 1/1 Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Analog [Chemical/Ingredient],Purine Antimetabolite [EPC],Purines [Chemical/Ingredient] N 20181231 70771-1142_a959d5ad-a725-4405-b65b-ce5421c8717d 70771-1142 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20171122 ANDA ANDA077625 Cadila Healthcare Limited ZONISAMIDE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70771-1143_a959d5ad-a725-4405-b65b-ce5421c8717d 70771-1143 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20171122 ANDA ANDA077625 Cadila Healthcare Limited ZONISAMIDE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70771-1144_a959d5ad-a725-4405-b65b-ce5421c8717d 70771-1144 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20171122 ANDA ANDA077625 Cadila Healthcare Limited ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70771-1145_456dcee0-a3e2-4cbc-9a33-91463a0d0430 70771-1145 HUMAN PRESCRIPTION DRUG escitalopram escitalopram TABLET, FILM COATED ORAL 20171207 ANDA ANDA077734 Cadila Healthcare Limited ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70771-1146_456dcee0-a3e2-4cbc-9a33-91463a0d0430 70771-1146 HUMAN PRESCRIPTION DRUG escitalopram escitalopram TABLET, FILM COATED ORAL 20171207 ANDA ANDA077734 Cadila Healthcare Limited ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70771-1147_456dcee0-a3e2-4cbc-9a33-91463a0d0430 70771-1147 HUMAN PRESCRIPTION DRUG escitalopram escitalopram TABLET, FILM COATED ORAL 20171207 ANDA ANDA077734 Cadila Healthcare Limited ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70771-1148_826816f2-cee8-4e49-b5ee-774d439fe99c 70771-1148 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride Benazepril hydrochloride TABLET, FILM COATED ORAL 20171113 ANDA ANDA078848 Cadila Healthcare Limited BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70771-1149_826816f2-cee8-4e49-b5ee-774d439fe99c 70771-1149 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride Benazepril hydrochloride TABLET, FILM COATED ORAL 20171113 ANDA ANDA078848 Cadila Healthcare Limited BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70771-1150_826816f2-cee8-4e49-b5ee-774d439fe99c 70771-1150 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride Benazepril hydrochloride TABLET, FILM COATED ORAL 20171113 ANDA ANDA078848 Cadila Healthcare Limited BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70771-1151_826816f2-cee8-4e49-b5ee-774d439fe99c 70771-1151 HUMAN PRESCRIPTION DRUG Benazepril hydrochloride Benazepril hydrochloride TABLET, FILM COATED ORAL 20171113 ANDA ANDA078848 Cadila Healthcare Limited BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70771-1152_bf5555f6-9f8a-48cc-b1c9-25b24d93f9f8 70771-1152 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20171205 ANDA ANDA078900 Cadila Healthcare Limited FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 70771-1159_5393cfec-9289-43cf-8edd-c4a3cbf710f6 70771-1159 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20171208 ANDA ANDA079213 Cadila Healthcare Limited IRBESARTAN 75 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70771-1160_5393cfec-9289-43cf-8edd-c4a3cbf710f6 70771-1160 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20171208 ANDA ANDA079213 Cadila Healthcare Limited IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70771-1161_5393cfec-9289-43cf-8edd-c4a3cbf710f6 70771-1161 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20171208 ANDA ANDA079213 Cadila Healthcare Limited IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70771-1163_f318552f-6743-4a2e-91b2-093473166bed 70771-1163 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 ANDA ANDA207743 Cadila Healthcare Limited LABETALOL HYDROCHLORIDE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70771-1164_f318552f-6743-4a2e-91b2-093473166bed 70771-1164 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 ANDA ANDA207743 Cadila Healthcare Limited LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70771-1165_f318552f-6743-4a2e-91b2-093473166bed 70771-1165 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 ANDA ANDA207743 Cadila Healthcare Limited LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70771-1166_486a3e3d-47da-4083-899b-817b05ae2fcb 70771-1166 HUMAN PRESCRIPTION DRUG desoximetasone desoximetasone OINTMENT TOPICAL 20171205 ANDA ANDA205206 Cadila Healthcare Limited DESOXIMETASONE 2.5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70771-1168_9b26e45d-eef8-463b-9773-9ce326ecb333 70771-1168 HUMAN PRESCRIPTION DRUG fesoterodine fumarate fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171207 ANDA ANDA204946 Cadila Healthcare Limited FESOTERODINE FUMARATE 4 mg/1 N 20181231 70771-1169_9b26e45d-eef8-463b-9773-9ce326ecb333 70771-1169 HUMAN PRESCRIPTION DRUG fesoterodine fumarate fesoterodine fumarate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171207 ANDA ANDA204946 Cadila Healthcare Limited FESOTERODINE FUMARATE 8 mg/1 N 20181231 70771-1172_6ca12cd8-bec1-4212-91c8-e2fdf7df1f40 70771-1172 HUMAN PRESCRIPTION DRUG aspirin-dipyridamole aspirin-dipyridamole CAPSULE ORAL 20180104 ANDA ANDA206753 Cadila Healthcare Limited ASPIRIN; DIPYRIDAMOLE 25; 200 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC] N 20181231 70771-1173_5bb1eda3-7788-4492-8d77-ac799a826946 70771-1173 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20171226 ANDA ANDA210086 Cadila Healthcare Limited AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70771-1174_5bb1eda3-7788-4492-8d77-ac799a826946 70771-1174 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20171226 ANDA ANDA210086 Cadila Healthcare Limited AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70771-1175_5bb1eda3-7788-4492-8d77-ac799a826946 70771-1175 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20171226 ANDA ANDA210086 Cadila Healthcare Limited AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70771-1176_5bb1eda3-7788-4492-8d77-ac799a826946 70771-1176 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20171226 ANDA ANDA210086 Cadila Healthcare Limited AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70771-1177_5bb1eda3-7788-4492-8d77-ac799a826946 70771-1177 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20171226 ANDA ANDA210086 Cadila Healthcare Limited AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70771-1178_5bb1eda3-7788-4492-8d77-ac799a826946 70771-1178 HUMAN PRESCRIPTION DRUG Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED ORAL 20171226 ANDA ANDA210086 Cadila Healthcare Limited AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20181231 70771-1179_6dcd8648-664c-4144-8f1a-85d49799e23c 70771-1179 HUMAN PRESCRIPTION DRUG Ziprasidone Ziprasidone CAPSULE ORAL 20171228 ANDA ANDA208988 Cadila Healthcare Limited ZIPRASIDONE HYDROCHLORIDE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 70771-1180_6dcd8648-664c-4144-8f1a-85d49799e23c 70771-1180 HUMAN PRESCRIPTION DRUG Ziprasidone Ziprasidone CAPSULE ORAL 20171228 ANDA ANDA208988 Cadila Healthcare Limited ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 70771-1181_6dcd8648-664c-4144-8f1a-85d49799e23c 70771-1181 HUMAN PRESCRIPTION DRUG Ziprasidone Ziprasidone CAPSULE ORAL 20171228 ANDA ANDA208988 Cadila Healthcare Limited ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 70771-1182_6dcd8648-664c-4144-8f1a-85d49799e23c 70771-1182 HUMAN PRESCRIPTION DRUG Ziprasidone Ziprasidone CAPSULE ORAL 20171228 ANDA ANDA208988 Cadila Healthcare Limited ZIPRASIDONE HYDROCHLORIDE 40 mg/1 Atypical Antipsychotic [EPC] N 20181231 70771-1183_f74cc72d-a7c3-4549-9c2b-a5ce262457b6 70771-1183 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE, GELATIN COATED ORAL 20171123 ANDA ANDA065217 Cadila Healthcare Limited CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 70771-1184_0cc21728-8fb0-43e5-ac53-4433e8ae1ea1 70771-1184 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20180103 ANDA ANDA206694 Cadila Healthcare Limited TAMOXIFEN CITRATE 10 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 70771-1185_0cc21728-8fb0-43e5-ac53-4433e8ae1ea1 70771-1185 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20180103 ANDA ANDA206694 Cadila Healthcare Limited TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 70771-1186_74e94f88-63a4-4048-a32b-ee97ac7137cc 70771-1186 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil TABLET, FILM COATED ORAL 20180104 ANDA ANDA207771 Cadila Healthcare Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70771-1187_74e94f88-63a4-4048-a32b-ee97ac7137cc 70771-1187 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil TABLET, FILM COATED ORAL 20180104 ANDA ANDA207771 Cadila Healthcare Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 20 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70771-1188_74e94f88-63a4-4048-a32b-ee97ac7137cc 70771-1188 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil TABLET, FILM COATED ORAL 20180104 ANDA ANDA207771 Cadila Healthcare Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 5; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70771-1189_74e94f88-63a4-4048-a32b-ee97ac7137cc 70771-1189 HUMAN PRESCRIPTION DRUG Amlodipine and olmesartan medoxomil Amlodipine and olmesartan medoxomil TABLET, FILM COATED ORAL 20180104 ANDA ANDA207771 Cadila Healthcare Limited AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL 10; 40 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70771-1190_b51ac8c1-c4ae-4b12-b80f-f0b07316418f 70771-1190 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20180202 ANDA ANDA210012 Cadila Healthcare Limited NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70771-1191_b51ac8c1-c4ae-4b12-b80f-f0b07316418f 70771-1191 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20180202 ANDA ANDA210012 Cadila Healthcare Limited NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70771-1192_b51ac8c1-c4ae-4b12-b80f-f0b07316418f 70771-1192 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20180202 ANDA ANDA210012 Cadila Healthcare Limited NIFEDIPINE 90 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70771-1193_60891932-67aa-4a46-a2d4-721859c77e17 70771-1193 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride INJECTION, SOLUTION EPIDURAL 20180131 ANDA ANDA202601 Cadila Healthcare Limited CLONIDINE HYDROCHLORIDE .1 mg/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70771-1194_60891932-67aa-4a46-a2d4-721859c77e17 70771-1194 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride INJECTION, SOLUTION EPIDURAL 20180131 ANDA ANDA202601 Cadila Healthcare Limited CLONIDINE HYDROCHLORIDE .5 mg/mL Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70773-100_6157d00e-9894-6038-e053-2a91aa0ab6e6 70773-100 HUMAN OTC DRUG Tonsin Allium cepa, Pulsatilla Pratensis, Sambucus nigra, Ferrum Phosphoricum, Hepar Sulphuris, Kali Muriaticum, Natrum Muriaticum, Kali Bichromicum, Mercurius Solubis TABLET ORAL 20171225 UNAPPROVED HOMEOPATHIC PRIVATE LABEL BRANDS CC SAMBUCUS NIGRA FLOWERING TOP; FERRUM PHOSPHORICUM; SODIUM CHLORIDE; POTASSIUM DICHROMATE; ALLIUM CEPA WHOLE; PULSATILLA PRATENSIS; CALCIUM SULFIDE; POTASSIUM CHLORIDE; MERCURIUS SOLUBILIS 3; 6; 6; 6; 3; 3; 6; 6; 10 [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X] N 20181231 70773-101_615538f6-2cb1-2df5-e053-2a91aa0a342d 70773-101 HUMAN OTC DRUG RSQ Five Aconitum napellus, Arnica montana, Chamomilla, Gelsemium sempervirens, Ignatia amara, Melissa officinalis, Phosphoricum acidum TABLET ORAL 20171225 UNAPPROVED HOMEOPATHIC Private Label Brands CC MELISSA OFFICINALIS; PHOSPHORIC ACID; ORNITHOGALUM UMBELLATUM FLOWERING TOP; MATRICARIA CHAMOMILLA; GELSEMIUM SEMPERVIRENS WHOLE; PRUNUS CERASIFERA FLOWER; CLEMATIS VITALBA FLOWER; ACONITUM NAPELLUS; ARNICA MONTANA; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER 3; 60; 5; 6; 60; 5; 5; 60; 60; 12; 5; 5 [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X] N 20181231 70773-102_61482eb0-bd24-3bb5-e053-2a91aa0a1529 70773-102 HUMAN OTC DRUG RSQ Five Junior ACONITUM NAPELLUS, Arnica montana, Chamomilla, Gelsemium sempervirens, Ignatia amara, Melissa officinalis, Phosphoricum acidum, Clematis Vitalba Flower, Helianthemum nummularium, Impatiens glandulifera flower, Ornithogalum umbellatum flower, Prunus cerasifera flower, TABLET ORAL 20171225 UNAPPROVED HOMEOPATHIC Private Label Brands CC ACONITUM NAPELLUS; ARNICA MONTANA; MATRICARIA CHAMOMILLA; STRYCHNOS IGNATII SEED; MELISSA OFFICINALIS; PHOSPHORIC ACID; GELSEMIUM SEMPERVIRENS WHOLE 60; 60; 6; 12; 3; 60; 60 [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X] N 20181231 70773-103_61566222-27b8-32d2-e053-2a91aa0a11b0 70773-103 HUMAN OTC DRUG RSQ FIVE Aconitum napellus, Arnica montana, Chamomilla, Gelsemium sempervirens, Ignatia amara, Melissa officinalis, Phosphoricum acidum, Clematis vitalba, Helianthemum nummularium, Impatiens glandulifera, Ornithogalum umbellatum, Prunus cerasifera LIQUID ORAL 20171225 UNAPPROVED HOMEOPATHIC PRIVATE LABEL BRANDS CC PHOSPHORIC ACID; ACONITUM NAPELLUS; MATRICARIA CHAMOMILLA; ORNITHOGALUM UMBELLATUM FLOWERING TOP; IMPATIENS GLANDULIFERA FLOWER; ARNICA MONTANA; MELISSA OFFICINALIS; PRUNUS CERASIFERA FLOWER; GELSEMIUM SEMPERVIRENS WHOLE; STRYCHNOS IGNATII SEED; HELIANTHEMUM NUMMULARIUM FLOWER; CLEMATIS VITALBA FLOWER 60; 60; 6; 5; 5; 60; 3; 5; 60; 12; 5; 5 [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X]; [hp_X]/100[hp_X] N 20181231 70774-201_3fdc9b6f-7835-3148-e054-00144ff88e88 70774-201 HUMAN PRESCRIPTION DRUG Metaxalone metaxalone TABLET ORAL 20161021 ANDA ANDA203399 Solis Generic Pharmaceuticals LLC METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20181231 70778-0002_3549697e-4632-448b-e054-00144ff8d46c 70778-0002 HUMAN OTC DRUG DONG SUNG MONELYN Zinc Pyrithione Suspension, Panthenol, Niacinamide, Biotin SHAMPOO TOPICAL 20160330 UNAPPROVED DRUG OTHER Daolcosmetic Co.,ltd PANTHENOL; PYRITHIONE ZINC; NIACINAMIDE; BIOTIN .5; 2.1; .3; .06 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 70780-103_32bc3903-4c2d-4196-ba83-c602bab0ee3d 70780-103 HUMAN OTC DRUG MyTerra Food Handler Wash Foam Benzalkonium Chloride SOAP TOPICAL 20171030 OTC MONOGRAPH NOT FINAL part333E PortionPac Chemical Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 70780-151_3a6973f4-a512-427e-8c11-94b429ce31f3 70780-151 HUMAN OTC DRUG MyTerra Hand Sanitizer Foam NA Benzalkonium Chloride SOAP TOPICAL 20171030 OTC MONOGRAPH NOT FINAL part333E PortionPac Chemical Corporation BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 70780-152_0e6af3d2-ad41-4388-8bad-2bb536596f02 70780-152 HUMAN OTC DRUG MyTerra Hand Sanitizer Foam Alcohol SOAP TOPICAL 20171030 OTC MONOGRAPH NOT FINAL part333E PortionPac Chemical Corporation ALCOHOL 650 mL/L N 20181231 70781-001_35f37080-59eb-1782-e054-00144ff8d46c 70781-001 HUMAN OTC DRUG BlanX White Shock SODIUM MONOFLUOROPHOSPHATE HYDROXYAPATITE CETRARIA ISLANDICA PASTE ORAL 20160614 OTC MONOGRAPH FINAL part355 Coswell Spa SODIUM MONOFLUOROPHOSPHATE .82 g/100g N 20181231 70781-002_589aebc1-3774-26a4-e053-2991aa0a3cc2 70781-002 HUMAN OTC DRUG BlanX White Shock SODIUM MONOFLUOROPHOSPHATE HYDROXYAPATITE CETRARIA ISLANDICA PASTE ORAL 20160614 OTC MONOGRAPH FINAL part355 Coswell Spa SODIUM MONOFLUOROPHOSPHATE .82 g/100g N 20181231 70781-003_589b532f-b7f3-be6f-e053-2991aa0a2eb9 70781-003 HUMAN OTC DRUG BlanX Intensive Stain Removal Sodium Monofluorophosphate, Sodium Fluoride PASTE ORAL 20170426 OTC MONOGRAPH FINAL part355 Coswell Spa SODIUM FLUORIDE; SODIUM MONOFLUOROPHOSPHATE .002; .01 g/100g; g/100g N 20181231 70781-004_589bb0b0-53ed-426e-e053-2a91aa0a6666 70781-004 HUMAN OTC DRUG BlanX Advanced Whitening Sodium Monofluorophosphate, Sodium Fluoride PASTE ORAL 20170426 OTC MONOGRAPH FINAL part355 Coswell Spa SODIUM FLUORIDE; SODIUM MONOFLUOROPHOSPHATE .08; .4 g/100g; g/100g N 20181231 70781-005_589c4217-3e7d-4dac-e053-2a91aa0aa3ac 70781-005 HUMAN OTC DRUG BlanX White Shock White and Protect Sodium Monofluorophosphate PASTE ORAL 20170426 OTC MONOGRAPH FINAL part355 Coswell Spa SODIUM MONOFLUOROPHOSPHATE .4 g/100g N 20181231 70781-006_51da281d-bfe4-7482-e054-00144ff8d46c 70781-006 HUMAN OTC DRUG Biorepair Sensitive Teeth Dicalcium Phosphate Dihydrate PASTE ORAL 20170602 UNAPPROVED DRUG OTHER Coswell Spa DIBASIC CALCIUM PHOSPHATE DIHYDRATE 18.6 g/100g N 20181231 70781-007_51db2e9a-bb67-23f2-e054-00144ff88e88 70781-007 HUMAN OTC DRUG Biorepair Total Protection Dicalcium Phosphate Dihydrate PASTE ORAL 20170604 UNAPPROVED DRUG OTHER Coswell Spa DIBASIC CALCIUM PHOSPHATE DIHYDRATE 15.11 g/100g N 20181231 70784-001_744d287f-9ab5-4bdb-8328-d5c3d2d2134a 70784-001 HUMAN OTC DRUG Biellee Pollen Whitening Wrinkle Time Repair Ampoule GLYCERIN CREAM TOPICAL 20160621 UNAPPROVED DRUG OTHER NSB CO., LTD. GLYCERIN 1.2 mg/10mL N 20181231 70784-002_6f83dee5-c777-416b-90c6-689740b9377d 70784-002 HUMAN OTC DRUG Biellee Pollen Whitening Wrinkle Time Repair Cream DIMETHICONE CREAM TOPICAL 20160621 OTC MONOGRAPH FINAL part347 NSB CO., LTD. DIMETHICONE .5 mg/50mL N 20181231 70784-003_38da8f0e-80bb-450e-b612-6daba06030eb 70784-003 HUMAN OTC DRUG Biellee Pollen Whitening Wrinkle Time Repair Serum DIMETHICONE CREAM TOPICAL 20160622 OTC MONOGRAPH FINAL part347 NSB CO., LTD. DIMETHICONE 1.02 mg/40mL N 20181231 70784-004_fdf6b3ea-61fd-4800-945a-cbf199781b14 70784-004 HUMAN OTC DRUG Biellee Pollen Hydra Pure Brightening Cream DIMETHICONE CREAM TOPICAL 20160621 UNAPPROVED DRUG OTHER NSB CO., LTD. DIMETHICONE .4 mg/50mL N 20181231 70784-005_97b4ef17-0baf-4d19-82b9-3788e0ca5085 70784-005 HUMAN OTC DRUG Ato Pollen Glycerin CREAM TOPICAL 20160922 OTC MONOGRAPH FINAL part347 NSB Co., Ltd. GLYCERIN 10 g/50mL N 20181231 70784-006_44723737-f3ee-4b9b-b05c-9c115a60fa7c 70784-006 HUMAN OTC DRUG Pollen UV Perfect Daily Sunscreen Titanium Dioxide, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20160922 OTC MONOGRAPH NOT FINAL part352 NSB Co., Ltd. OCTINOXATE; OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE 3.5; 2.5; 1.5; 1 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 70785-011_676689a5-5d70-44f8-9017-3643f88129d8 70785-011 HUMAN PRESCRIPTION DRUG Zurampic lesinurad TABLET, FILM COATED ORAL 20171003 NDA NDA207988 Ironwood Pharmaceuticals, Inc. LESINURAD 200 mg/1 Urate Transporter 1 Inhibitor [EPC],Urate Transporter 1 Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA] N 20191231 70785-021_35f2ecf5-77ab-4183-9583-cf9a6808c71a 70785-021 HUMAN PRESCRIPTION DRUG Duzallo lesinurad and allopurinol TABLET, FILM COATED ORAL 20171003 NDA NDA209203 Ironwood Pharmaceuticals, Inc. LESINURAD; ALLOPURINOL 200; 200 mg/1; mg/1 Urate Transporter 1 Inhibitor [EPC],Urate Transporter 1 Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 70785-022_35f2ecf5-77ab-4183-9583-cf9a6808c71a 70785-022 HUMAN PRESCRIPTION DRUG Duzallo lesinurad and allopurinol TABLET, FILM COATED ORAL 20171003 NDA NDA209203 Ironwood Pharmaceuticals, Inc. LESINURAD; ALLOPURINOL 200; 300 mg/1; mg/1 Urate Transporter 1 Inhibitor [EPC],Urate Transporter 1 Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 70786-0001_d943d620-d7ee-4455-aa8c-9f8d82ede406 70786-0001 HUMAN PRESCRIPTION DRUG Methylprednisolone Methylprednisolone TABLET ORAL 19971031 ANDA ANDA040189 Unit Dose Services METHYLPREDNISOLONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70786-0002_86db4daa-e95e-43a2-9cea-7bbe6b7d399c 70786-0002 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 Unit Dose Services FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70786-0003_7ef7ae9e-608f-489a-ae05-5c194b58965c 70786-0003 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Unit Dose Services GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70786-0004_45b211a7-7b07-4a38-b141-f6240a884d15 70786-0004 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-0005_45b211a7-7b07-4a38-b141-f6240a884d15 70786-0005 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-0006_45b211a7-7b07-4a38-b141-f6240a884d15 70786-0006 HUMAN PRESCRIPTION DRUG simvastatin simvastatin TABLET, FILM COATED ORAL 20080226 ANDA ANDA078155 Unit Dose Services SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-0017_a1de67e9-5943-4b24-95fa-d57f5fb7e280 70786-0017 HUMAN PRESCRIPTION DRUG levofloxacin levofloxacin TABLET, FILM COATED ORAL 20121110 ANDA ANDA077652 Unit Dose Services LEVOFLOXACIN 750 mg/1 N 20181231 70786-0022_05df513f-83ca-403d-8b1b-1de77a223cca 70786-0022 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Unit Dose Services LEVOFLOXACIN 500 mg/1 N 20181231 70786-0027_3e49ad84-68a3-43ce-8fed-4b415e283f2b 70786-0027 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA201146 Unit Dose Services DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 70786-0028_3e49ad84-68a3-43ce-8fed-4b415e283f2b 70786-0028 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA201146 Unit Dose Services DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 70786-0029_66a0fc72-2bd8-46e8-8b98-45cfe393a270 70786-0029 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20051109 ANDA ANDA065256 Unit Dose Services AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 70786-0031_ff672dbc-63b3-445f-b0bc-736debc85be9 70786-0031 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Unit Dose Services AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 70786-0060_3abff4b7-841e-4f9b-9c45-9aac10141419 70786-0060 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET ORAL 20121016 ANDA ANDA202928 Unit Dose Services CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 70786-0072_0940cbcb-0060-45a0-a2b4-1a3d6ab2f8fb 70786-0072 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20011217 ANDA ANDA075636 Unit Dose Services LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-0090_5e66b6a9-6d56-4b5a-980d-4030b68da05b 70786-0090 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20100528 ANDA ANDA090121 Unit Dose Services FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 70786-0099_844f3598-c966-4163-834a-34f440fbe387 70786-0099 HUMAN PRESCRIPTION DRUG ketoconazole ketoconazole CREAM TOPICAL 20040428 ANDA ANDA076294 Unit Dose Services KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70786-0100_feb734c8-253d-4b74-87d8-e92b08d335af 70786-0100 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Unit Dose Services METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70786-0102_9d7ed9d2-2c98-40d1-a6c7-e9f3f77befce 70786-0102 HUMAN PRESCRIPTION DRUG Cephalexin cephalexin CAPSULE ORAL 20150602 ANDA ANDA062713 Unit Dose Services CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 70786-0104_19d528af-f482-4566-8f08-279014d8112d 70786-0104 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Unit Dose Services METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70786-0115_37814f51-b1cb-43d5-ae89-56d7b7e8cc7b 70786-0115 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Unit Dose Services LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70786-0116_4dfcbaa9-7513-40c1-aa88-17a5da56f553 70786-0116 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Unit Dose Services FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70786-0117_4dfcbaa9-7513-40c1-aa88-17a5da56f553 70786-0117 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Unit Dose Services FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70786-0120_fbb057fc-d3be-452d-9506-950b6c61a10f 70786-0120 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20151015 NDA AUTHORIZED GENERIC NDA018225 Unit Dose Services BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70786-0121_24615720-dedb-4fa1-8fae-6ad8e00bcc51 70786-0121 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20010416 ANDA ANDA075805 Unit Dose Services FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70786-0123_f1f08485-bf61-4d36-8e2c-72d8599a0449 70786-0123 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20120717 ANDA ANDA091650 Unit Dose Services ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-0124_5c37db01-a6b2-4d79-9d0a-27a3549fbc4e 70786-0124 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Unit Dose Services MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70786-0125_41644fde-b8a8-4a50-939c-101a1f664c76 70786-0125 HUMAN PRESCRIPTION DRUG meloxicam meloxicam TABLET ORAL 20070307 ANDA ANDA077927 Unit Dose Services MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70786-0126_5d2a705d-baa2-4b90-ba92-e98494500cec 70786-0126 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Unit Dose Services GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70786-0127_8d498d31-eba5-4b26-a3fd-1eaf5259f54b 70786-0127 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Unit Dose Services AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70786-0128_8d498d31-eba5-4b26-a3fd-1eaf5259f54b 70786-0128 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Unit Dose Services AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70786-0129_c6d23837-7e81-44e3-aaf7-71ebeb957eb1 70786-0129 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 Unit Dose Services BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70786-0130_c6d23837-7e81-44e3-aaf7-71ebeb957eb1 70786-0130 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 19961121 ANDA ANDA074700 Unit Dose Services BUMETANIDE 2 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70786-0135_b984d596-e21b-4480-bbc3-069e5d5c5dbe 70786-0135 HUMAN PRESCRIPTION DRUG Losortan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20101004 ANDA ANDA078243 Unit Dose Services LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70786-0136_e6b1c067-246d-4112-b8f3-5075701e0502 70786-0136 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Unit Dose Services CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70786-0137_e6b1c067-246d-4112-b8f3-5075701e0502 70786-0137 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Unit Dose Services CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70786-0141_a2d2e710-53ef-4319-8c69-afcafaf326d0 70786-0141 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Unit Dose Services LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-0142_c5a8fe0d-f5d5-416d-a06b-795fe22f0671 70786-0142 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Unit Dose Services CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70786-0144_c5a8fe0d-f5d5-416d-a06b-795fe22f0671 70786-0144 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Unit Dose Services CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70786-0145_c5a8fe0d-f5d5-416d-a06b-795fe22f0671 70786-0145 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Unit Dose Services CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70786-0146_e8747a94-1ad7-4295-9de1-583acfd9f12b 70786-0146 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA076048 Unit Dose Services OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70786-0156_e115d85e-d294-45a0-8361-e733e78cb982 70786-0156 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19870109 ANDA ANDA071450 Unit Dose Services ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 70786-0160_d9c7787d-8d63-4f50-9a02-9dc2d902afa0 70786-0160 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20100715 ANDA ANDA090931 Unit Dose Services TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70786-0168_2502c0f6-bb0d-4c08-87e8-c421a345379f 70786-0168 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Unit Dose Services ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-0169_2502c0f6-bb0d-4c08-87e8-c421a345379f 70786-0169 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Unit Dose Services ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-0170_2502c0f6-bb0d-4c08-87e8-c421a345379f 70786-0170 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Unit Dose Services ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-0172_2a54a82a-d665-4456-aff0-3ebde6156ec7 70786-0172 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Unit Dose Services PREDNISONE 5 mg/1 N 20181231 70786-0180_4a1ee22f-69f5-477c-98aa-3e47dcb28315 70786-0180 HUMAN PRESCRIPTION DRUG Mupirocin Mupirocin OINTMENT TOPICAL 20110608 ANDA ANDA090480 Unit Dose Services MUPIROCIN 20 mg/g RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA] N 20181231 70786-0190_0c9cdb34-f5ef-4445-b545-90ee7ea26c66 70786-0190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Unit Dose Services NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70786-0201_10e08d6f-6b7b-4e4d-9920-02dfc7c8f089 70786-0201 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Unit Dose Services DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70786-0208_e26dddad-43dc-40b9-9d01-d1d57409137a 70786-0208 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110101 ANDA ANDA077534 Unit Dose Services CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 70786-0212_b06d5686-3c30-458d-b5e6-48891d6a7eb2 70786-0212 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150429 ANDA ANDA202824 Unit Dose Services DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70786-0213_b06d5686-3c30-458d-b5e6-48891d6a7eb2 70786-0213 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150422 ANDA ANDA202824 Unit Dose Services DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70786-0214_b06d5686-3c30-458d-b5e6-48891d6a7eb2 70786-0214 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150422 ANDA ANDA202824 Unit Dose Services DOXAZOSIN MESYLATE 8 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 70786-0222_495c61ab-73cc-40bd-aff9-5430c6e30650 70786-0222 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20100517 ANDA ANDA090705 Unit Dose Services GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70786-0224_1af6773b-6bc7-48f0-9df8-11ee2e17afbd 70786-0224 HUMAN PRESCRIPTION DRUG ALENDRONATE SODIUM Alendronate sodium TABLET ORAL 20080804 ANDA ANDA076768 Unit Dose Services ALENDRONATE SODIUM 70 mg/1 Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient] N 20181231 70786-0231_2666f0e2-f5f1-4a33-8522-7f6e4450dfe2 70786-0231 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 20180801 ANDA ANDA091672 Unit Dose Services OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70786-0241_1b90ee20-14ee-4ba8-b696-42cf12012afe 70786-0241 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20140303 ANDA ANDA203245 Unit Dose Services AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70786-0248_2cd13ae4-ecdb-4288-b4ab-881a63f99b6e 70786-0248 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Unit Dose Services RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70786-0255_8eff82a0-44f8-4c2e-909e-254f788ce914 70786-0255 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Unit Dose Services CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70786-0256_8eff82a0-44f8-4c2e-909e-254f788ce914 70786-0256 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20100601 ANDA ANDA078384 Unit Dose Services CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 70786-0258_56794289-6cca-45d8-9645-683b17e72d1e 70786-0258 HUMAN PRESCRIPTION DRUG Clotrimazole and Betamethasone Dipropionate Clotrimazole and Betamethasone Dipropionate CREAM TOPICAL 20010605 ANDA ANDA075502 Unit Dose Services CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE 10; .5 mg/g; mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70786-0272_07a3bfe5-1487-42d8-8af5-bf2be3afb897 70786-0272 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100913 ANDA ANDA076899 Unit Dose Services SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 70786-0321_d485e15c-5613-4f66-a684-612ef4b7e7ac 70786-0321 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20151221 ANDA ANDA091625 Unit Dose Services IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70786-0337_c26ad3e7-b300-4596-a320-c7739240f3ca 70786-0337 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Unit Dose Services BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70786-0338_c26ad3e7-b300-4596-a320-c7739240f3ca 70786-0338 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Unit Dose Services BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70786-0351_e18a04d1-b36b-4512-a507-f1f588c00ce3 70786-0351 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Unit Dose Services LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70786-0360_92a74231-2534-4e5a-8c4f-260cbd13ccd7 70786-0360 HUMAN PRESCRIPTION DRUG losartan potassium Losartan Potassium TABLET, FILM COATED ORAL 20110601 ANDA ANDA091497 Unit Dose Services LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 70786-0376_3dcd1b17-1ed0-4d16-9df9-1ce51589d89c 70786-0376 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160602 ANDA ANDA202554 Unit Dose Services LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70786-0396_beb79d7c-684f-48c9-a30f-db2d03c29647 70786-0396 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Unit Dose Services OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70786-0411_8874ef3b-a92a-4c85-9878-bb217558540c 70786-0411 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Unit Dose Services CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 70786-0435_2919983f-4508-4bce-886b-0f686444fa98 70786-0435 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20020129 ANDA ANDA075967 Unit Dose Services METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70786-0437_3114c8d3-c453-4174-82cc-f1a03f9c5a72 70786-0437 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20150217 ANDA ANDA076363 Unit Dose Services DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 70786-0441_3114c8d3-c453-4174-82cc-f1a03f9c5a72 70786-0441 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20150217 ANDA ANDA076363 Unit Dose Services DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 70786-0467_3ac7de01-947c-4126-b79a-eceff011df95 70786-0467 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Unit Dose Services LOVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-0468_3ac7de01-947c-4126-b79a-eceff011df95 70786-0468 HUMAN PRESCRIPTION DRUG Lovastatin lovastatin TABLET ORAL 20071101 ANDA ANDA078296 Unit Dose Services LOVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-0511_66c16411-5bb2-44d4-bac3-65df585af410 70786-0511 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Unit Dose Services FENOFIBRATE 67 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 70786-0514_e27bedc2-3089-415a-bc2b-452f140cf18d 70786-0514 HUMAN PRESCRIPTION DRUG DIGOXIN DIGOXIN TABLET ORAL 20140114 NDA AUTHORIZED GENERIC NDA020405 Unit Dose Services DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 70786-0515_87689e4d-294b-41b5-b754-dce237316d86 70786-0515 HUMAN PRESCRIPTION DRUG Ciprofloxacin Ciprofloxacin TABLET, FILM COATED ORAL 20040609 ANDA ANDA076794 Unit Dose Services CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 70786-0522_66c16411-5bb2-44d4-bac3-65df585af410 70786-0522 HUMAN PRESCRIPTION DRUG Fenofibrate FENOFIBRATE CAPSULE ORAL 20100201 ANDA ANDA075868 Unit Dose Services FENOFIBRATE 134 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 70786-0555_b91eae9b-6c10-4e67-b0bc-cb6aa5cd35e7 70786-0555 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 Unit Dose Services GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70786-0682_33f4acbf-727f-444d-bf54-24d7abdb3678 70786-0682 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Unit Dose Services IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70786-0684_f868b405-c3ac-44b0-bf6e-5de6260a3192 70786-0684 HUMAN PRESCRIPTION DRUG IBU Ibuprofen TABLET ORAL 20081120 ANDA ANDA075682 Unit Dose Services IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70786-0752_832981c4-6251-4320-a5bc-428bef787c8e 70786-0752 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19950222 ANDA ANDA074056 Unit Dose Services ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70786-0787_832981c4-6251-4320-a5bc-428bef787c8e 70786-0787 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20041116 ANDA ANDA074056 Unit Dose Services ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70786-0813_1bb3240f-c13b-4a39-a95f-acf3c8d4eb55 70786-0813 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Unit Dose Services GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70786-0814_1bb3240f-c13b-4a39-a95f-acf3c8d4eb55 70786-0814 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Unit Dose Services GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 70786-0831_43fac48b-9049-4d92-8b74-3c76613b3743 70786-0831 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Unit Dose Services DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 70786-0900_150f4879-347f-4d52-9d02-0b5886eb6457 70786-0900 HUMAN PRESCRIPTION DRUG Glipizide ER Glipizide TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060403 ANDA ANDA076467 Unit Dose Services GLIPIZIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70786-0923_99fbcf8a-f3b7-46aa-b76b-371f58e09fc6 70786-0923 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70786-0924_99fbcf8a-f3b7-46aa-b76b-371f58e09fc6 70786-0924 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70786-0925_99fbcf8a-f3b7-46aa-b76b-371f58e09fc6 70786-0925 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70786-0926_99fbcf8a-f3b7-46aa-b76b-371f58e09fc6 70786-0926 HUMAN PRESCRIPTION DRUG ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET ORAL 20091211 ANDA ANDA075483 Unit Dose Services ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20181231 70786-1000_86db4daa-e95e-43a2-9cea-7bbe6b7d399c 70786-1000 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 Unit Dose Services FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 70786-1001_63c05fa9-507a-4a4b-a1dc-3d2b6d2d2280 70786-1001 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021121 ANDA ANDA065093 Unit Dose Services AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 70786-1002_63c05fa9-507a-4a4b-a1dc-3d2b6d2d2280 70786-1002 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021127 ANDA ANDA065117 Unit Dose Services AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 70786-1298_fad24e1d-92f8-426b-854c-95c74ba6c71c 70786-1298 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 Unit Dose Services KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 70786-1496_876bdd36-f4ca-468e-9891-63efb05f80ac 70786-1496 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051114 ANDA ANDA065211 Unit Dose Services AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70786-1507_e80bc47d-5b63-40e3-9d73-cafe9156e806 70786-1507 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19910917 ANDA ANDA073026 Unit Dose Services ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70786-1712_16048329-3688-4a9f-b61a-873660a403f2 70786-1712 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20151019 ANDA ANDA040616 Unit Dose Services WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70786-1713_16048329-3688-4a9f-b61a-873660a403f2 70786-1713 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150505 ANDA ANDA040616 Unit Dose Services WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70786-1714_16048329-3688-4a9f-b61a-873660a403f2 70786-1714 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150407 ANDA ANDA040616 Unit Dose Services WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70786-1715_16048329-3688-4a9f-b61a-873660a403f2 70786-1715 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150714 ANDA ANDA040616 Unit Dose Services WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70786-1716_16048329-3688-4a9f-b61a-873660a403f2 70786-1716 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150609 ANDA ANDA040616 Unit Dose Services WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70786-1718_16048329-3688-4a9f-b61a-873660a403f2 70786-1718 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150722 ANDA ANDA040616 Unit Dose Services WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70786-1721_16048329-3688-4a9f-b61a-873660a403f2 70786-1721 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150407 ANDA ANDA040616 Unit Dose Services WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 70786-2115_f8e0fa9d-db9b-4774-9aa7-9a6a2adeb646 70786-2115 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Unit Dose Services ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 70786-2116_f8e0fa9d-db9b-4774-9aa7-9a6a2adeb646 70786-2116 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20030627 ANDA ANDA075798 Unit Dose Services ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 70786-2550_79339a0c-16d9-44ec-b022-e05b4f425833 70786-2550 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19960326 ANDA ANDA074514 Unit Dose Services DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70786-2578_e6efd6dc-a49b-4008-ab6c-c6d5ece84d61 70786-2578 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Unit Dose Services ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-2579_e6efd6dc-a49b-4008-ab6c-c6d5ece84d61 70786-2579 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Unit Dose Services ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-2580_e6efd6dc-a49b-4008-ab6c-c6d5ece84d61 70786-2580 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Unit Dose Services ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-2640_8b5a59e6-6dd0-4201-bb47-d37580bda2dc 70786-2640 HUMAN PRESCRIPTION DRUG Fluticasone Fluticasone Propionate SPRAY, METERED NASAL 20120109 ANDA ANDA078492 Unit Dose Services FLUTICASONE PROPIONATE 50 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70786-2671_e6efd6dc-a49b-4008-ab6c-c6d5ece84d61 70786-2671 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Unit Dose Services ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70786-3142_eca4977e-caaa-4cc2-b5e2-203e9c24e505 70786-3142 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE, GELATIN COATED ORAL 19840507 ANDA ANDA062396 Unit Dose Services DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 70786-3523_e6b1c067-246d-4112-b8f3-5075701e0502 70786-3523 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Unit Dose Services CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 70786-3797_476816d9-1a87-40c1-ba38-7983c101570a 70786-3797 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION INTRABRONCHIAL 20101104 ANDA ANDA077839 Unit Dose Services ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 70786-3798_cc776109-a8bc-410c-a1a1-cdec98b63879 70786-3798 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110301 ANDA ANDA075693 Unit Dose Services IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 70786-3841_75bbc01d-2f84-4dbd-a19c-a86d1ef83625 70786-3841 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Unit Dose Services FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70786-4096_7b2d7339-348c-4e68-b448-7db6d57121fd 70786-4096 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072234 Unit Dose Services BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 70786-4097_7b2d7339-348c-4e68-b448-7db6d57121fd 70786-4097 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 19880721 ANDA ANDA072235 Unit Dose Services BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20181231 70786-5522_49fb29ba-a99d-4ed0-837d-db2e432f92ab 70786-5522 HUMAN PRESCRIPTION DRUG FENOFIBRATE FENOFIBRATE TABLET ORAL 20100201 ANDA ANDA076509 Unit Dose Services FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 70786-6624_8d498d31-eba5-4b26-a3fd-1eaf5259f54b 70786-6624 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Unit Dose Services AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 70786-7073_7ef7ae9e-608f-489a-ae05-5c194b58965c 70786-7073 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Unit Dose Services GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 70786-7376_c7b5d12e-1af3-485d-bc52-bf51253100f9 70786-7376 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Unit Dose Services HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 70786-9055_19d528af-f482-4566-8f08-279014d8112d 70786-9055 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Unit Dose Services METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70786-9056_19d528af-f482-4566-8f08-279014d8112d 70786-9056 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Unit Dose Services METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70788-579_0622cd54-1f64-4193-88db-eae3f84658b9 70788-579 HUMAN OTC DRUG Follinique Minoxidil SOLUTION TOPICAL 20161027 ANDA ANDA078176 Premium Distribution, LLC MINOXIDIL 20 mg/mL N 20181231 70788-580_ab7844b9-fc1f-40da-9992-2c6eda824ee3 70788-580 HUMAN OTC DRUG Regen 5% Minoxidil Topical Solution SOLUTION TOPICAL 20161201 ANDA ANDA076239 Premium Distribution, LLC MINOXIDIL 50 mg/mL N 20181231 70791-001_43e7c84c-87d2-4116-a233-1eb9a882cc50 70791-001 HUMAN OTC DRUG Lqd ACNE BLEMISH TREATMENT control Salicylic acid LOTION TOPICAL 20160801 OTC MONOGRAPH FINAL part333D AMAC ENTERPRISES PROPRIETARY LIMITED SALICYLIC ACID 2 g/100mL N 20181231 70794-207_3a3b5f8f-9684-4005-a0c0-83e5c4e449b5 70794-207 HUMAN OTC DRUG DermaER Psoriasis Therapeutic Salicylic Acid OINTMENT TOPICAL 20160629 OTC MONOGRAPH FINAL part358B Chen Cohen Industries Inc. SALICYLIC ACID 20 mg/g N 20191231 70795-1010_de57873f-56ea-4a7a-ab3a-fbdf4739b1d6 70795-1010 HUMAN OTC DRUG LAXATIVE BISACODYL SUPPOSITORY RECTAL 20170329 OTC MONOGRAPH NOT FINAL part334 GRAXCELL PHARMACEUTICAL, LLC BISACODYL 10 mg/1 N 20181231 70795-1021_c6fcf2aa-3b37-432c-ba35-a4f239d3c897 70795-1021 HUMAN OTC DRUG Hemorrhoidal COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY RECTAL 20170329 OTC MONOGRAPH FINAL part346 GRAXCELL PHARMACEUTICAL, LLC COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE 1768.8; 5 mg/1; mg/1 N 20181231 70795-1120_eaf2c803-9232-478c-ad31-743bb8ea99ba 70795-1120 HUMAN OTC DRUG Normal Salt Sodium Chloride TABLET ORAL 20171002 OTC MONOGRAPH FINAL part349 GRAXCELL PHARMACEUTICAL, LLC SODIUM CHLORIDE 1 g/1 N 20181231 70795-1130_b795d58e-5923-431d-b84b-57df70ebb550 70795-1130 HUMAN OTC DRUG Sodium Bicarbonate 5 gr Sodium Bicarbonate TABLET ORAL 20171002 OTC MONOGRAPH NOT FINAL part334 GRAXCELL PHARMACEUTICAL, LLC SODIUM BICARBONATE 325 mg/1 N 20181231 70795-1140_e03e633b-92e5-41df-b619-180245dd58c4 70795-1140 HUMAN OTC DRUG Sodium Bicarbonate 10 gr Sodium Bicarbonate TABLET ORAL 20171002 OTC MONOGRAPH NOT FINAL part334 GRAXCELL PHARMACEUTICAL, LLC SODIUM BICARBONATE 650 mg/1 N 20181231 70795-1160_5bd46f87-5e00-2d23-e053-2a91aa0a8959 70795-1160 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20171018 ANDA ANDA090564 GRAXCELL PHARMACEUTICAL, LLC. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70795-1170_5bd46f87-5e00-2d23-e053-2a91aa0a8959 70795-1170 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, FILM COATED ORAL 20171018 ANDA ANDA090564 GRAXCELL PHARMACEUTICAL, LLC. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70795-2412_5bc37545-ab6f-dcc7-e053-2a91aa0a8eae 70795-2412 HUMAN PRESCRIPTION DRUG HYDROCORTISONE ACETATE Hydrocortisone acetate SUPPOSITORY RECTAL 20171018 UNAPPROVED DRUG OTHER GRAXCELL PHARMACEUTICAL, LLC. HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 70795-8014_af53ecde-7581-49a0-bd0c-b1d3422acd37 70795-8014 HUMAN OTC DRUG NASAL SALINE SODIUM CHLORIDE LIQUID NASAL 20170701 UNAPPROVED DRUG OTHER GRAXCELL PHARMACEUTICAL, LLC SODIUM CHLORIDE 6.5 mg/mL N 20181231 70795-8020_5fb4ac52-e3ef-0ce9-e053-2991aa0a49fc 70795-8020 HUMAN OTC DRUG CLOTRIMAZOLE CLOTRIMAZOLE SOLUTION TOPICAL 20171208 OTC MONOGRAPH FINAL part333C GRAXCELL PHARMACEUTICAL, LLC. CLOTRIMAZOLE 1 g/mL N 20181231 70796-001_c7bd7ca2-ad86-43f8-ad90-cf39256536a9 70796-001 HUMAN OTC DRUG Puriton EYE RELIEF DROPS HOMEOPATHIC Alumina, Calcarea Fluorica, Ferrum Metallicum, Ferrum Phosphoricum, Natrum Muriaticum, Phosphorous, Sulphur, Titanium Metallicum, Zincum Metallicum SOLUTION/ DROPS OPHTHALMIC 20161001 UNAPPROVED HOMEOPATHIC Kadesh, Inc. ALUMINUM OXIDE; CALCIUM FLUORIDE; IRON; FERROSOFERRIC PHOSPHATE; SODIUM CHLORIDE; PHOSPHORUS; SULFUR; TITANIUM; ZINC 5; 6; 7; 7; 4; 6; 4; 7; 8 [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL N 20181231 70796-002_3b4a8763-1e6e-4f62-8bde-851478f26856 70796-002 HUMAN OTC DRUG Puriton SKIN PROTECTANT HOMEOPATHIC Alumina, Calcarea Fluorica, Calcarea Silicata, Magnesia Sulphurica, Silicea, Sulphur, Titanium Metallicum, Zincum Metallicum SPRAY TOPICAL 20161001 UNAPPROVED HOMEOPATHIC Kadesh, Inc. ALUMINUM OXIDE; CALCIUM FLUORIDE; CALCIUM SILICATE; MAGNESIUM SULFATE HEPTAHYDRATE; SILICON DIOXIDE; SULFUR; TITANIUM; ZINC 7; 6; 5; 7; 4; 4; 7; 8 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL N 20181231 70796-003_d2f1e75f-0a90-49c4-8450-e8d8f0cbab97 70796-003 HUMAN OTC DRUG Puriton FACIAL SKIN PROTECTANT AND ACNE TREATMENT HOMEOPATHIC Alumina, Calcarea Silicata, Ferrum Metallicum, Magnesia Sulphurica, Phosphorous, Sulphur, Titanium Metallicum, Zincum Metallicum SOLUTION TOPICAL 20161001 UNAPPROVED HOMEOPATHIC Kadesh, Inc. ALUMINUM OXIDE; CALCIUM SILICATE; IRON; MAGNESIUM SULFATE HEPTAHYDRATE; PHOSPHORUS; SULFUR; TITANIUM; ZINC 7; 5; 7; 7; 6; 4; 7; 8 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL N 20181231 70796-004_5ee6e2db-f7f8-4596-9426-c14928bd024c 70796-004 HUMAN OTC DRUG Puriton FIRST AID ANTISEPTIC AND ANTIBIOTIC Solution Silicea, Sulphur, Phosphorus, Calcarea Silicata, Natrum Nitricum, Ferrum Muriaticum, Kali Silicatum SPRAY TOPICAL 20170101 UNAPPROVED HOMEOPATHIC Kadesh, Inc. SILICON DIOXIDE; SULFUR; PHOSPHORUS; CALCIUM SILICATE; SODIUM NITRATE; FERRIC CHLORIDE HEXAHYDRATE; POTASSIUM SILICATE 4; 4; 6; 5; 4; 7; 6 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 70796-005_8622a0f0-e80e-454e-bb8f-d69f33cb6b0f 70796-005 HUMAN OTC DRUG NASAL MIST Calcarea Silicata, Silicea, Sulphur, Natrum Muriaticum, Ferrum Metallicum, Ferrum Phosphoricum, Phosphorus, Ferrum Muriaticum, Titanium Metallicum SPRAY NASAL 20180201 UNAPPROVED HOMEOPATHIC Kadesh, Inc. CALCIUM SILICATE; SILICON DIOXIDE; SULFUR; SODIUM CHLORIDE; IRON; FERROSOFERRIC PHOSPHATE; PHOSPHORUS; FERRIC CHLORIDE HEXAHYDRATE; TITANIUM 5; 4; 4; 4; 7; 7; 6; 7; 7 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20191231 70797-230_365e0605-b636-226e-e054-00144ff88e88 70797-230 HUMAN OTC DRUG Nuby Teething Gel Teething Gel GEL TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part356 Talbot’s Pharmaceuticals Family Products, LLC. EUGENOL 13 mg/g E 20171231 70797-230_427ae0ef-0d4c-025e-e054-00144ff8d46c 70797-230 HUMAN OTC DRUG Nuby Teething Gel Teething Gel GEL TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part356 Talbot’s Pharmaceuticals Family Products, LLC. EUGENOL 13 mg/g E 20171231 70797-231_4bf87172-0be8-45bd-e054-00144ff8d46c 70797-231 HUMAN OTC DRUG Nuby Teething Gel Teething Gel GEL TOPICAL 20170622 OTC MONOGRAPH NOT FINAL part356 Talbot’s Pharmaceuticals Family Products, LLC. EUGENOL 8 mg/g N 20181231 70798-415_32aa75a5-49b4-35ab-e054-00144ff88e88 70798-415 HUMAN OTC DRUG zinc oxide, titanium dioxide zinc oxide, titanium dioxide CREAM TOPICAL 20160711 OTC MONOGRAPH FINAL part352 MATCHCo Inc. TITANIUM DIOXIDE; ZINC OXIDE 4.9; 5.9 mg/g; mg/g E 20171231 70800-100_f0426748-c5ce-4098-9d3b-98ca9c63864b 70800-100 HUMAN OTC DRUG Magnolia Serum Magnolia Kobus Flower LIQUID TOPICAL 20160601 UNAPPROVED DRUG OTHER Salon de Savon MAGNOLIA KOBUS FLOWERING TOP 4.36 g/30mL N 20181231 70801-003_5b34354d-aa46-6bea-e053-2a91aa0addff 70801-003 HUMAN PRESCRIPTION DRUG Zilretta triamcinolone acetonide extended-release injectable suspension KIT INTRA-ARTICULAR 20171006 NDA NDA208845 Flexion Therapeutics, Inc. N 20181231 70803-023_429aea0b-bd79-4fef-e054-00144ff88e88 70803-023 HUMAN OTC DRUG ACTIVE ARGAN 02.3(TM) PLASMA PRO 50 FEATHERWEIGHT DAY BROAD SPECTRUM SPF 20 WITH PROPRIETARY A.P.I. and ACTIVATED ARGAN COMPLEX(TM) ZINC OXIDE CREAM TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 SIBORG ZINC OXIDE 140 mg/mL E 20171231 70803-300_3fb6648b-d5b5-7276-e054-00144ff88e88 70803-300 HUMAN OTC DRUG SIROT 24-Hour Hand Care Transformative Glass Technology Age-Fighting Protection Day and Night OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20160705 OTC MONOGRAPH NOT FINAL part352 SIBORG OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 60; 25; 2.2; 29 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 70803-400_36f7d97c-0e7b-035e-e054-00144ff88e88 70803-400 HUMAN OTC DRUG SIROT The Complete Beauty Experience Transformative Glass Technology The First Steps to Younger Looking Skin OCTOCRYLENE, ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE KIT 20160630 OTC MONOGRAPH NOT FINAL part352 SIBORG, LLC N 20181231 70803-410_4299d178-4aa4-5e22-e054-00144ff8d46c 70803-410 HUMAN OTC DRUG SIROT Essential Day Transformative Glass Technology Anti-Aging Sunscreen Broad Spectrum SPF 20 OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20160705 OTC MONOGRAPH NOT FINAL part352 SIBORG OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 60; 25; 7; 38 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 70803-420_62d272e2-2743-da97-e053-2a91aa0a9eb5 70803-420 HUMAN OTC DRUG SIROT DAYTIME HAND PERFECTION TRANSFORMATIVE GLASS TECHNOLOGY MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 20 OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20160705 OTC MONOGRAPH NOT FINAL part352 SIBORG OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 60; 25; 2.2; 29 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 70803-450_3fa1d69c-97f7-2762-e054-00144ff88e88 70803-450 HUMAN OTC DRUG Sirot Hand and Body Trio Transformative glass Technology Complete Age Resistance Day and Night Octinoxate, Octocrylene, Titanium dioxide, Zinc Oxide CREAM TOPICAL 20161014 OTC MONOGRAPH NOT FINAL part352 SIBORG OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 60; 25; 2.2; 29 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 70803-500_62d30e4c-97cc-3d60-e053-2a91aa0a8adf 70803-500 HUMAN OTC DRUG Sachet Active Argan 02.3 Plasma Pro 50 Featherweight Day Broad Spectrum SPF 20 With Proprietary A.P.I. and Activated Argan Complex ZINC OXIDE CREAM TOPICAL 20161208 OTC MONOGRAPH NOT FINAL part352 Siborg ZINC OXIDE 140 mg/mL N 20191231 70803-550_4d9c80a2-9bbf-5948-e054-00144ff88e88 70803-550 HUMAN OTC DRUG Sirot complete Hand Care Collection Transformative Glass Technology Hydrate Restore Protect OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE KIT 20170412 OTC MONOGRAPH NOT FINAL part352 Siborg LLC N 20181231 70804-112_42b09a53-7f5d-461b-e054-00144ff88e88 70804-112 HUMAN PRESCRIPTION DRUG MONSEL FERRIC, SUBSULTATE PASTE TOPICAL 20170127 UNAPPROVED DRUG OTHER PURTEX FERRIC SUBSULFATE 1 g/1 Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] E 20171231 70805-001_36e7ab2c-d7f2-5d76-e054-00144ff8d46c 70805-001 HUMAN OTC DRUG Brompton and Langley Moisturizing Hand Sanitizer Market Strawberry Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Cita International Limited ALCOHOL .26 g/26g E 20171231 70805-002_377210c0-c480-6127-e054-00144ff88e88 70805-002 HUMAN OTC DRUG Brompton and Langley Moisturizing Candy and Apple Swirl scented Hand Sanitizer Candy and Apple Swirl Benzalkonium Chloride GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Cita International Limited ALCOHOL .26 g/26g E 20171231 70805-003_3771c177-35e1-57c4-e054-00144ff88e88 70805-003 HUMAN OTC DRUG Brompton and Langley Coconut Water and Habiscus Hand Sanitizer Coconut Water and Habiscus Alcohol Denat GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Cita International Limited ALCOHOL .26 g/26g E 20171231 70805-004_377462f3-c213-6955-e054-00144ff8d46c 70805-004 HUMAN OTC DRUG Brompton and Langley Ginger Lily and Lime Moisturizing Hand Sanitizer ginger lily and lime Alcohol Denat. GEL TOPICAL 20160712 OTC MONOGRAPH NOT FINAL part333E Cita International Limited ALCOHOL .26 g/26g E 20171231 70805-005_377268a8-67d7-03be-e054-00144ff8d46c 70805-005 HUMAN OTC DRUG Brompton and Langley Green Apple Hand Sanitizer Green Apple Alcohol Denat GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Cita International Limited ALCOHOL .26 g/26g E 20171231 70805-006_378640e0-f4e1-35e7-e054-00144ff88e88 70805-006 HUMAN OTC DRUG Brompton and Langley Lavender Vanilla Hand Sanitizer Lavender Vanilla Alcohol Denat GEL TOPICAL 20160603 OTC MONOGRAPH NOT FINAL part333E Cita International Limited ALCOHOL .26 g/26g E 20171231 70805-007_37886b50-79ba-1613-e054-00144ff8d46c 70805-007 HUMAN OTC DRUG Brompton and Langley Vanilla Marshmallow Hand Sanitizer Vanilla Marshmallow Alcohol Denat GEL TOPICAL 20160713 OTC MONOGRAPH NOT FINAL part333E Cita International Limited ALCOHOL .26 g/26g E 20171231 70805-008_37887791-2052-1793-e054-00144ff8d46c 70805-008 HUMAN OTC DRUG Brompton and Langley Zesty Lemon Hand Sanitizer Zesty Lemon Alcohol Denat GEL TOPICAL 20160713 OTC MONOGRAPH NOT FINAL part333E Cita International Limited ALCOHOL .26 g/26g E 20171231 70809-1601_386fefdc-a3ff-1131-e054-00144ff8d46c 70809-1601 HUMAN OTC DRUG Active Daily Defense zinc oxide cream CREAM TOPICAL 20160725 OTC MONOGRAPH FINAL part352 Urban Skin Solutions ZINC OXIDE 12 mg/100mL N 20181231 70809-1602_386eeffc-36bc-4e24-e054-00144ff8d46c 70809-1602 HUMAN OTC DRUG Age Defying Mineral Moisturizer zinc oxide, octinoxate cream CREAM TOPICAL 20160725 OTC MONOGRAPH FINAL part352 Urban Skin Solutions ZINC OXIDE; OCTINOXATE 9; 9 mg/100mL; mg/100mL N 20181231 70809-1603_3876aa00-66eb-3ad4-e054-00144ff8d46c 70809-1603 HUMAN OTC DRUG Clarifying Complexion Protection zinc oxide cream CREAM TOPICAL 20160725 OTC MONOGRAPH FINAL part352 Urban Skin Solutions ZINC OXIDE 20 mg/100mL N 20181231 70809-1604_387a2035-0fa3-27ff-e054-00144ff88e88 70809-1604 HUMAN OTC DRUG Skin Lightening Cream hydroquinone cream CREAM TOPICAL 20160725 OTC MONOGRAPH NOT FINAL part358A Urban Skin Solutions HYDROQUINONE 2 mg/100mL N 20181231 70810-001_680f8bfa-22a1-4650-bbd7-6bbde08388d6 70810-001 HUMAN OTC DRUG Pro Brighten Tooth whitening Gel Hydrogen Peroxide GEL ORAL 20160706 OTC MONOGRAPH NOT FINAL part356 Sangleaf Pharm., Co Ltd HYDROGEN PEROXIDE 3 g/100g E 20171231 70811-001_441eb19f-4281-01b7-e054-00144ff8d46c 70811-001 HUMAN OTC DRUG Korium Wound care Calendula officinalis 1X HPUS SPRAY TOPICAL 20161220 UNAPPROVED HOMEOPATHIC GR8BIO LLC CALENDULA OFFICINALIS WHOLE 1 [hp_X]/20mL N 20181231 70812-001_db50480b-79b4-4b89-8ace-1935b25d8c3f 70812-001 HUMAN OTC DRUG White Labs Hydrogen Peroxide LIQUID ORAL 20160707 OTC MONOGRAPH NOT FINAL part356 BIO STECH CO., LTD. HYDROGEN PEROXIDE .42 g/15g E 20171231 70815-001_1c08672a-8118-4f1c-819b-4c638c1b61bb 70815-001 HUMAN OTC DRUG Balm Stick Camphor, Menthol, Methyl Salicylate STICK TOPICAL 20160731 OTC MONOGRAPH NOT FINAL part348 Indo Abadi Sari Makmur, PT METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 7; 13; 12 g/100g; g/100g; g/100g E 20171231 70818-001_55bf9c1f-9c66-7021-e054-00144ff88e88 70818-001 HUMAN OTC DRUG isLeaf Cushion Concealer 21 titanium dioxide LIQUID TOPICAL 20170808 OTC MONOGRAPH FINAL part347 C3 Co., Ltd. ZINC OXIDE 1.6 g/100g N 20181231 70818-002_5636b9e0-7ee8-6cea-e054-00144ff88e88 70818-002 HUMAN OTC DRUG isLeaf Cushion Concealer 23 titanium dioxide LIQUID TOPICAL 20170808 OTC MONOGRAPH FINAL part347 C3 Co., Ltd. ZINC OXIDE 1.6 g/100g N 20181231 70818-003_5636b9e0-7eea-6cea-e054-00144ff88e88 70818-003 HUMAN OTC DRUG isLeaf Long Lasting Waterproof Eyeliner Black methylparaben LIQUID TOPICAL 20170808 UNAPPROVED DRUG OTHER C3 Co., Ltd. METHYLPARABEN .3 g/100g N 20181231 70818-004_5636f97e-88d4-6c64-e054-00144ff8d46c 70818-004 HUMAN OTC DRUG isLeaf Satin Lip and Cheek Duo Berry Red dimethicone LIQUID TOPICAL 20170808 OTC MONOGRAPH FINAL part347 C3 Co., Ltd. DIMETHICONE .15 g/100g N 20181231 70818-005_56393d37-51dc-507b-e054-00144ff8d46c 70818-005 HUMAN OTC DRUG isLeaf Satin Lip and Cheek Duo Coral Orange dimethicone LIQUID TOPICAL 20170808 OTC MONOGRAPH FINAL part347 C3 Co., Ltd. DIMETHICONE .15 g/100g N 20181231 70818-006_56393d37-51ec-507b-e054-00144ff8d46c 70818-006 HUMAN OTC DRUG isLeaf Satin Lip and Cheek Duo Sweet Pink dimethicone LIQUID TOPICAL 20170808 OTC MONOGRAPH FINAL part347 C3 Co., Ltd. DIMETHICONE .15 g/100g N 20181231 70818-007_5637541b-a6c4-0a47-e054-00144ff88e88 70818-007 HUMAN OTC DRUG isLeaf Tattoo Eyebrow Brown methylparaben GEL TOPICAL 20170808 UNAPPROVED DRUG OTHER C3 Co., Ltd. METHYLPARABEN .3 g/100g N 20181231 70818-008_57b3e831-94b0-0db8-e053-2a91aa0a1418 70818-008 HUMAN OTC DRUG isLeaf Long Lasting Waterproof Eyeliner Brown methylparaben GEL TOPICAL 20170808 UNAPPROVED DRUG OTHER C3 Co., Ltd. METHYLPARABEN .3 g/100g N 20181231 70818-010_57c9c06f-d40b-2851-e053-2a91aa0aa09e 70818-010 HUMAN OTC DRUG isLeaf Shine Smooth Lip Glaze Soft Pink mineral oil LIQUID TOPICAL 20170808 OTC MONOGRAPH FINAL part347 C3 Co., Ltd. MINERAL OIL 8 g/100mL N 20181231 70818-011_57c90ac7-aec1-2049-e053-2991aa0a18ee 70818-011 HUMAN OTC DRUG isLeaf Shine Smooth Lip Glaze Red mineral oil LIQUID TOPICAL 20170808 OTC MONOGRAPH FINAL part347 C3 Co., Ltd. MINERAL OIL 8 g/100mL N 20181231 70818-012_57c99383-a241-97d7-e053-2991aa0a6ab1 70818-012 HUMAN OTC DRUG isLeaf Shine Smooth Lip Glaze Orange mineral oil LIQUID TOPICAL 20170808 OTC MONOGRAPH FINAL part347 C3 Co., Ltd. MINERAL OIL 8 g/100mL N 20181231 70818-013_57c99383-a24e-97d7-e053-2991aa0a6ab1 70818-013 HUMAN OTC DRUG isLeaf Shine Smooth Lip Glaze Pearl Red mineral oil LIQUID TOPICAL 20170808 OTC MONOGRAPH FINAL part347 C3 Co., Ltd. MINERAL OIL 8 g/100mL N 20181231 70818-014_57ca4c0b-1d0c-13bd-e053-2991aa0a6d8d 70818-014 HUMAN OTC DRUG isLeaf Energy Water glycerin CREAM TOPICAL 20170808 OTC MONOGRAPH NOT FINAL part347 C3 Co., Ltd. GLYCERIN 8 g/100g N 20181231 70818-015_57ca4c0b-1d06-13bd-e053-2991aa0a6d8d 70818-015 HUMAN OTC DRUG isLeaf Botanic Shield Deep Pore Cleasing Foam glycerin LIQUID TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part347 C3 Co., Ltd. GLYCERIN 11 g/100g N 20181231 70818-017_57cb82e7-e58d-4812-e053-2a91aa0a1c0d 70818-017 HUMAN OTC DRUG isLeaf Botanic Shield Facial Barrier GelCream glycerin CREAM TOPICAL 20170808 OTC MONOGRAPH NOT FINAL part347 C3 Co., Ltd. GLYCERIN 10 g/100g N 20181231 70818-018_57cb82e7-e59b-4812-e053-2a91aa0a1c0d 70818-018 HUMAN OTC DRUG isLeaf Botanic Shield Pollutant Defending Mask glycerin LIQUID TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part347 C3 Co., Ltd. GLYCERIN 9 g/100g N 20181231 70818-019_57cc108c-9950-35e7-e053-2991aa0aef0d 70818-019 HUMAN OTC DRUG isLeaf Botanic Shield Shieldig Mist glycerin LIQUID TOPICAL 20170828 OTC MONOGRAPH NOT FINAL part347 C3 Co., Ltd. GLYCERIN 7 g/100g N 20181231 70818-020_57cc42b7-1fa4-7fa4-e053-2a91aa0ac565 70818-020 HUMAN OTC DRUG isLeaf Clinic Lime Cleansing Foam glycerin LIQUID TOPICAL 20170808 OTC MONOGRAPH NOT FINAL part347 C3 Co., Ltd. GLYCERIN 8 g/100g N 20181231 70820-751_480628ca-cfa0-001b-e054-00144ff8d46c 70820-751 HUMAN OTC DRUG Cyantific Protecting Daily Broad Spectrum SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, HOMOSALATE, OCTOCRYLENE CREAM TOPICAL 20160708 OTC MONOGRAPH NOT FINAL part352 Beagle Bioproducts Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; HOMOSALATE; OCTOCRYLENE 20; 10; 40; 70; 70 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 70821-000_62e72690-489a-7825-e053-2a91aa0af8f7 70821-000 HUMAN OTC DRUG TENSOGEL Antiseptic Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20180110 OTC MONOGRAPH NOT FINAL part333E Biolimpieza de Centroamerica, S.A. ALCOHOL 650 mg/mL N 20191231 70821-001_62e72690-48ab-7825-e053-2a91aa0af8f7 70821-001 HUMAN OTC DRUG TENSOGEL Antiseptic Handwash Triclosan GEL TOPICAL 20180110 OTC MONOGRAPH NOT FINAL part333E Biolimpieza de Centroamerica, S. A. TRICLOSAN 1 mg/mL N 20191231 70823-101_66989f80-e8b6-4af5-997c-5546ea4cc3d6 70823-101 HUMAN OTC DRUG Masterbalm Camphor LOTION TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part348 Biomaster-agro Kereskedelmi Es Szolgaltato Korlatolt Felelossegu Tarsasag CAMPHOR (NATURAL) .7 g/100mL E 20171231 70825-0001_37552a5c-65da-34fb-e054-00144ff88e88 70825-0001 HUMAN OTC DRUG SNOW WHITE NIACINAMIDE CREAM TOPICAL 20150705 UNAPPROVED DRUG OTHER Zenpia NIACINAMIDE 2 g/100g N 20181231 70825-0002_375686b7-65ea-719c-e054-00144ff88e88 70825-0002 HUMAN OTC DRUG SNOW WHITE ESSENCE NIACINAMIDE LIQUID TOPICAL 20150705 UNAPPROVED DRUG OTHER Zenpia NIACINAMIDE 2 g/100mL N 20181231 70825-0003_37552c86-346f-38bb-e054-00144ff88e88 70825-0003 HUMAN OTC DRUG SNOW WHITE CLEANSING FOAM NIACINAMIDE CREAM TOPICAL 20150705 UNAPPROVED DRUG OTHER Zenpia NIACINAMIDE .1 g/100g N 20181231 70825-0004_3755cd2f-0aa4-00a5-e054-00144ff8d46c 70825-0004 HUMAN OTC DRUG SNOW WHITE MILKY NIACINAMIDE LOTION TOPICAL 20150705 UNAPPROVED DRUG OTHER Zenpia NIACINAMIDE 2 g/100g N 20181231 70825-0005_37e1b1e1-a73b-24aa-e054-00144ff8d46c 70825-0005 HUMAN OTC DRUG Prestige Snail Repairing Booster NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20150705 UNAPPROVED DRUG OTHER Zenpia NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 70825-0006_37e1b1e1-a74c-24aa-e054-00144ff8d46c 70825-0006 HUMAN OTC DRUG Prestige Snail Repairing Ampoule NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20150705 UNAPPROVED DRUG OTHER Zenpia NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 70825-0007_37e314fc-d8a0-5c84-e054-00144ff88e88 70825-0007 HUMAN OTC DRUG Prestige Snail Repairing NIACINAMIDE, ADENOSINE CREAM TOPICAL 20150705 UNAPPROVED DRUG OTHER Zenpia NIACINAMIDE; ADENOSINE 2; .04 g/100g; g/100g N 20181231 70825-0008_383ce892-de5d-62e8-e054-00144ff88e88 70825-0008 HUMAN OTC DRUG SNOW WHITE MILKY PACK NIACINAMIDE CREAM TOPICAL 20150705 UNAPPROVED DRUG OTHER Zenpia NIACINAMIDE 2 g/100g N 20181231 70825-0009_383a88ba-c1ff-021c-e054-00144ff88e88 70825-0009 HUMAN OTC DRUG SNOW WHITE SPOT NIACINAMIDE GEL TOPICAL 20150705 UNAPPROVED DRUG OTHER Zenpia NIACINAMIDE 2 g/100g N 20181231 70825-0010_3b7e9eb6-6ec8-01d4-e054-00144ff88e88 70825-0010 HUMAN OTC DRUG SECRET KEY NATURAL CC CUSHION SPF50 PLUS / 01 LIGHT CC TITANIUM DIOXIDE, ETHYLHEXYL METHOXYCINNAMETE, ETHYLHEXYL SALICYLATE, 4-METHYLBENZYLIDENE CAMPHOR LIQUID TOPICAL 20150705 UNAPPROVED DRUG OTHER Zenpia OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ENZACAMENE 7; 3; 12; 3 g/100g; g/100g; g/100g; g/100g N 20181231 70825-0012_3b80502e-9a22-2fe3-e054-00144ff88e88 70825-0012 HUMAN OTC DRUG SECRET KEY NATURAL CC CUSHION SPF50 PLUS / 02 NATURAL CC TITANIUM DIOXIDE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, 4-METHYLBENZYLIDENE CAMPHOR LIQUID TOPICAL 20150705 UNAPPROVED DRUG OTHER Zenpia OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ENZACAMENE 7; 3; 12; 3 g/100g; g/100g; g/100g; g/100g N 20181231 70825-0013_3d757a28-7882-5197-e054-00144ff8d46c 70825-0013 HUMAN OTC DRUG SECRET KEY TATTOO COVER CUSHION SPF50 PLUS (21 LIGHT BEIGE) TITANIUM DIOXIDE, CYCLOPENTASILOXANE, ETHYLHEXYL METHOXYCINNAMATE, PROPYLENE GLYCOL, PHENYL TRIMETHICONE LIQUID TOPICAL 20160927 UNAPPROVED DRUG OTHER Zenpia TITANIUM DIOXIDE; CYCLOMETHICONE 5; OCTINOXATE; PROPYLENE GLYCOL; PHENYL TRIMETHICONE 12; 8; 7; 5; 3.5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70825-0014_3d87fdc4-6ae4-1d73-e054-00144ff8d46c 70825-0014 HUMAN OTC DRUG SECRET KEY TATTOO COVER CUSHION SPF50 PLUS (23 NATURAL BEIGE) TITANIUM DIOXIDE, CYCLOPENTASILOXANE, ETHYLHEXYL METHOXYCINNAMATE, PROPYLENE GLYCOL, PHENYL TRIMETHICONE LIQUID TOPICAL 20160927 UNAPPROVED DRUG OTHER Zenpia TITANIUM DIOXIDE; CYCLOMETHICONE 5; OCTINOXATE; PROPYLENE GLYCOL; PHENYL TRIMETHICONE 12; 8; 7; 5; 3.5 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70825-0015_52d797c0-72fb-3f3d-e054-00144ff88e88 70825-0015 HUMAN OTC DRUG Secret Key Thanakha Aqua SunLotion SPF35 PA PLUS PLUS PLUS ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part352 Zenpia OCTISALATE; OCTINOXATE; AVOBENZONE 4.4; 6.1; 2.7 g/100g; g/100g; g/100g N 20181231 70825-0016_52e6ccef-561b-49e2-e054-00144ff88e88 70825-0016 HUMAN OTC DRUG Secret Key Thanakha Mild SunCream SPF47 PA PLUS PLUS PLUS TITANIUM DIOXIDE, ZINC OXIDE, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170601 UNAPPROVED DRUG OTHER Zenpia ZINC OXIDE; NIACINAMIDE; TITANIUM DIOXIDE; ADENOSINE 11.12; 2; 2.83; .04 g/100g; g/100g; g/100g; g/100g N 20181231 70826-576_ce767775-e3b9-46bd-b7ee-390cbfc7ce50 70826-576 HUMAN OTC DRUG HONGOSAN DSP Tolnaftate KIT 20160709 OTC MONOGRAPH FINAL part333C Dsp Skin Care Products E 20171231 70827-001_37feef39-9879-5779-e054-00144ff8d46c 70827-001 HUMAN OTC DRUG Antibacterial Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20160718 OTC MONOGRAPH NOT FINAL part333E Top Trenz ALCOHOL 62 mL/100mL N 20181231 70833-758_483061a1-d070-24b9-e054-00144ff8d46c 70833-758 HUMAN OTC DRUG Le Lou Collagen Day SPF 30 OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20160816 OTC MONOGRAPH NOT FINAL part352 Dougoud Cosmetics, LLC OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 30; 30 mg/g; mg/g; mg/g N 20181231 70834-101_4ed7e69d-3ca4-45f8-a725-c91ed5a5e954 70834-101 HUMAN OTC DRUG MD CELL Scalp Pyrithione zinc, Panthenol, Niacinamide, Menthol, Salicylic Acid SHAMPOO TOPICAL 20160718 UNAPPROVED DRUG OTHER A Joint-stock Corporation GMC Holdings PYRITHIONE ZINC; PANTHENOL; NIACINAMIDE; MENTHOL; SALICYLIC ACID 2.7; 1.5; .9; .21; .03 g/300mL; g/300mL; g/300mL; g/300mL; g/300mL E 20171231 70834-102_4b16bd52-27f3-4f56-9aec-0148ddf62b5c 70834-102 HUMAN OTC DRUG MD CELL Solution Niacinamide, Panthenol, Salicylic Acid SPRAY TOPICAL 20160722 UNAPPROVED DRUG OTHER A Joint-stock Corporation GMC Holdings NIACINAMIDE; PANTHENOL; SALICYLIC ACID .003; .002; .00001 1/100mL; 1/100mL; 1/100mL E 20171231 70834-103_ef57e71a-310f-4834-995d-43214d2adf4d 70834-103 HUMAN OTC DRUG MD CELL Menthol, Salicylic Acid SHAMPOO TOPICAL 20160722 UNAPPROVED DRUG OTHER A Joint-stock Corporation GMC Holdings MENTHOL; SALICYLIC ACID .0015; .00001 1/100mL; 1/100mL E 20171231 70836-001_d86006b1-31d6-453a-b2fa-e36fe27f177d 70836-001 HUMAN OTC DRUG SINCERE PAIN RELIEF MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20130501 OTC MONOGRAPH NOT FINAL part348 Jiangsu Jiangsu Sincere Pharmaceutical Co., Ltd MENTHOL; METHYL SALICYLATE 2; 2 g/100g; g/100g E 20171231 70837-001_ae117200-8ffb-4af3-8cc0-05eaae87c7bc 70837-001 HUMAN OTC DRUG FOOT DETOX ZINC OXIDE PATCH TOPICAL 20160509 OTC MONOGRAPH FINAL part347 Sichuan Fragrant Plant Biotechnology Co, Ltd ZINC OXIDE 8.3 g/100g E 20171231 70839-112_d6df62fa-065d-465d-aa7c-f8810b520a0e 70839-112 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20080801 NDA NDA022107 Noden Pharma USA, Inc. ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 150; 12.5 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 70839-125_d6df62fa-065d-465d-aa7c-f8810b520a0e 70839-125 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20080801 NDA NDA022107 Noden Pharma USA, Inc. ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 150; 25 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 70839-150_8a4ad8d9-6bf2-41aa-84bc-3d6bdf421cdd 70839-150 HUMAN PRESCRIPTION DRUG Tekturna aliskiren hemifumarate TABLET, FILM COATED ORAL 20070305 NDA NDA021985 Noden Pharma USA, Inc. ALISKIREN HEMIFUMARATE 150 mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA] N 20191231 70839-300_8a4ad8d9-6bf2-41aa-84bc-3d6bdf421cdd 70839-300 HUMAN PRESCRIPTION DRUG Tekturna aliskiren hemifumarate TABLET, FILM COATED ORAL 20070305 NDA NDA021985 Noden Pharma USA, Inc. ALISKIREN HEMIFUMARATE 300 mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA] N 20191231 70839-312_d6df62fa-065d-465d-aa7c-f8810b520a0e 70839-312 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20080801 NDA NDA022107 Noden Pharma USA, Inc. ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 300; 12.5 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 70839-325_d6df62fa-065d-465d-aa7c-f8810b520a0e 70839-325 HUMAN PRESCRIPTION DRUG Tekturna HCT aliskiren hemifumarate and hydrochlorothiazide TABLET, FILM COATED ORAL 20080801 NDA NDA022107 Noden Pharma USA, Inc. ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE 300; 25 mg/1; mg/1 Renin Inhibitor [EPC],Renin Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 70840-001_47e93fa1-f12c-6ecd-e054-00144ff8d46c 70840-001 HUMAN OTC DRUG White and Elm Everyday SPF 15 Zinc Oxide LOTION TOPICAL 20170209 OTC MONOGRAPH FINAL part352 White & Elm LLC ZINC OXIDE 146 mg/mL N 20181231 70842-101_597ed98e-272e-4003-88f3-57c6a9481af3 70842-101 HUMAN PRESCRIPTION DRUG Baxdela delafloxacin meglumine TABLET ORAL 20170619 NDA NDA208610 Melinta Therapeutics, Inc DELAFLOXACIN MEGLUMINE 450 mg/1 Fluoroquinolone Antibacterial [EPC],Fluoroquinolones [Chemical/Ingredient] N 20181231 70842-102_597ed98e-272e-4003-88f3-57c6a9481af3 70842-102 HUMAN PRESCRIPTION DRUG Baxdela delafloxacin meglumine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170619 NDA NDA208611 Melinta Therapeutics, Inc DELAFLOXACIN MEGLUMINE 300 mg/10.5mL Fluoroquinolone Antibacterial [EPC],Fluoroquinolones [Chemical/Ingredient] N 20181231 70843-101_0c3dab82-f543-4693-85eb-c2b737939ab8 70843-101 HUMAN OTC DRUG Powerbooster original Hydrogenated lecithin, Caffeine CREAM TOPICAL 20160719 UNAPPROVED DRUG OTHER Peterpanlab HYDROGENATED SOYBEAN LECITHIN; CAFFEINE .1; .05 g/100mL; g/100mL N 20181231 70845-0010_386db1d4-3da0-223b-e054-00144ff8d46c 70845-0010 HUMAN OTC DRUG UNDA HAIR MOISTURIZING Bambusa Vulgaris Extract, Shea Butter, Eucalyptus Globulus Leaf Oil CREAM TOPICAL 20160724 UNAPPROVED DRUG OTHER UNDA EUCALYPTUS GLOBULUS LEAF; BAMBUSA VULGARIS TOP; SHEA BUTTER .05; 52.51; 1 g/100mL; g/100mL; g/100mL E 20171231 70845-0011_386db1d4-3da6-223b-e054-00144ff8d46c 70845-0011 HUMAN OTC DRUG UNDA MOSITURIZING Salicylic Acid, Bambusa Vulgaris Extract, Eucalyptus Globulus Leaf Oil SHAMPOO TOPICAL 20160701 UNAPPROVED DRUG OTHER UNDA SALICYLIC ACID; EUCALYPTUS GLOBULUS LEAF; BAMBUSA VULGARIS TOP .001; .1; 53.13 g/100mL; g/100mL; g/100mL E 20171231 70848-410_3ae64b5a-7aef-6239-e054-00144ff88e88 70848-410 HUMAN OTC DRUG Acqua Aroma Hand Sanitizer Gel Alcohol GEL TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part333A Smell It Industria e Comercio Ltda ALCOHOL 21.024 mL/30mL E 20171231 70848-413_3ae64b5a-7aef-6239-e054-00144ff88e88 70848-413 HUMAN OTC DRUG Acqua Aroma Hand Sanitizer Gel Alcohol GEL TOPICAL 20160901 OTC MONOGRAPH NOT FINAL part333A Smell It Industria e Comercio Ltda ALCOHOL 266.304 mL/380mL E 20171231 70849-200_3d19523d-7cb5-2f2f-e054-00144ff88e88 70849-200 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE STRONTIUM esomeprazole strontium CAPSULE, DELAYED RELEASE ORAL 20160915 NDA NDA202342 R2 Pharma, LLC ESOMEPRAZOLE STRONTIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70849-400_3d19523d-7cb5-2f2f-e054-00144ff88e88 70849-400 HUMAN PRESCRIPTION DRUG ESOMEPRAZOLE STRONTIUM esomeprazole strontium CAPSULE, DELAYED RELEASE ORAL 20160915 NDA NDA202342 R2 Pharma, LLC ESOMEPRAZOLE STRONTIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 70851-0001_6862110d-922b-4b72-849e-5c0e29c9aba7 70851-0001 HUMAN OTC DRUG Clear Sinuses apis mellifica, baptisia tinctoria, colocynthis, hepar sulphuris calcareum, histaminum hydrochloricum, hydrastis canadensis, ignatia amara, kali bichromicum, lemna minor, mercurius vivus, pulsatilla, rhus toxicodenron, sabadilla, thuja occidentalis LIQUID ORAL 20160901 UNAPPROVED HOMEOPATHIC Ella Care, LLC APIS MELLIFERA; BAPTISIA TINCTORIA ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CALCIUM SULFIDE; HISTAMINE DIHYDROCHLORIDE; GOLDENSEAL; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; LEMNA MINOR; MERCURY; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SCHOENOCAULON OFFICINALE SEED; THUJA OCCIDENTALIS LEAFY TWIG 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 70854-0001_381c3611-7a2c-4300-e054-00144ff88e88 70854-0001 HUMAN OTC DRUG NATURAL PURE BALANCING HAIR SALICYLIC ACID SHAMPOO TOPICAL 20160721 OTC MONOGRAPH FINAL part358H PRULANT SALICYLIC ACID .01 g/100mL E 20171231 70856-3434_5f26fb54-0f5d-0107-e053-2a91aa0a359a 70856-3434 HUMAN OTC DRUG Defense Antifungal Medicated Bar Tolnaftate SOAP TOPICAL 20160801 OTC MONOGRAPH FINAL part333C Defense Soap LLC TOLNAFTATE 1 g/100g N 20181231 70857-001_e5caa494-62e4-491f-a968-1c72f75fff24 70857-001 HUMAN OTC DRUG Traulevium Arnica Montana Radix, Calendula Officinalis, Hamamelis Virginiana, Echinacea, Echinacea Purpurea, Chamomilla, Symphytum Officinale, Bellis Perennis, Hypericum Perforatum, Millefolium, Aconitum Napellus, Belladonna, Mercurius Solubilis, Hepar Sulphuris Calcareum. OINTMENT TOPICAL 20161012 UNAPPROVED HOMEOPATHIC Medical Technology Products, Inc. ARNICA MONTANA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; MATRICARIA RECUTITA; COMFREY ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ATROPA BELLADONNA; MERCURIUS SOLUBILIS; CALCIUM SULFIDE 3; 225; 225; 75; 75; 75; 6; 50; 6; 45; 4; 1; 6; 6 [hp_X]/50g; mg/50g; mg/50g; mg/50g; mg/50g; mg/50g; [hp_X]/50g; mg/50g; [hp_X]/50g; mg/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g N 20181231 70857-002_a4fee32e-3ddd-4ff5-a110-3a65ad2d59a2 70857-002 HUMAN OTC DRUG Traulevium Belladonna, Arnica Montana Radix, Aconitum Napellus, Chamomilla, Symphytum Officinale, Calendula Officinalis, Hamamelis Virginiana, Millefolium, Hepar Sulphuris Calcareum, Mercurius Solubilis, Hypericum Perforatum, Bellis Perennis, Echinacea Angustifolia, Echinacea Purpurea. TABLET, CHEWABLE ORAL 20161003 UNAPPROVED HOMEOPATHIC Medical Technology Products, Inc. ATROPA BELLADONNA; ARNICA MONTANA; ACONITUM NAPELLUS; MATRICARIA RECUTITA; COMFREY ROOT; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ACHILLEA MILLEFOLIUM; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; HYPERICUM PERFORATUM; BELLIS PERENNIS; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA 4; 3; 3; 3; 8; 2; 2; 3; 8; 8; 3; 2; 2; 2 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 70857-003_24f2fa4e-38f2-4c99-bec9-565e373d9072 70857-003 HUMAN OTC DRUG TRAULEVIUM Pain Relief Drops Arnica Rad, Aconitum Nap, Chamomilla, Belladonna, Symphytum, Bellis, Calendula, Echinacea, Echinacea Purp, Hamamelis, Hypericum, Millefolium, Hepar Sulph Calc, Merc Solub. LIQUID ORAL 20161011 UNAPPROVED HOMEOPATHIC Medical Technology Products, Inc. ARNICA MONTANA ROOT; ACONITUM NAPELLUS; MATRICARIA RECUTITA; ATROPA BELLADONNA; COMFREY ROOT; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; CALCIUM SULFIDE; MERCURIUS SOLUBILIS 3; 3; 3; 4; 8; 2; 2; 2; 2; 2; 3; 3; 8; 8 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 70857-004_efec3645-53d5-43d2-ad31-4c7a1b033ea3 70857-004 HUMAN OTC DRUG Traulevium Pain Relief Gel Arnica Montana, Calendula Officinalis, Hamamelis Virginiana, Echinacea, Echinacea Purpurea, Chamomilla, Symphytum Officinale, Bellis Perennis, Hypericum Perforatum, Millefolium, Aconitum Napellus, Belladonna, Mercurius Solubilis, Hepar Sulphuris Calcareum. GEL TOPICAL 20160919 UNAPPROVED HOMEOPATHIC Medical Technology Products, Inc. ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; MATRICARIA RECUTITA; COMFREY ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ATROPA BELLADONNA; MERCURIUS SOLUBILIS; CALCIUM SULFIDE 3; .45; .45; .15; .15; .15; 6; .1; 6; .09; 4; 1; 6; 6 [hp_X]/100g; g/100g; g/100g; g/100g; g/100g; g/100g; [hp_X]/100g; g/100g; [hp_X]/100g; g/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g; [hp_X]/100g N 20181231 70859-001_3c04e42a-0b84-0567-e054-00144ff8d46c 70859-001 HUMAN PRESCRIPTION DRUG NuSurgePak Surgical Prep/CarePak chlorhexidine gluconate, mupirocin, dimethicone KIT 20160729 ANDA ANDA090480 Nucare Pharmaceuticals Inc N 20181231 70859-002_612bf0ce-6809-5c00-e053-2a91aa0a9d8f 70859-002 HUMAN PRESCRIPTION DRUG NuTriaRX CreamPak TRIAMCINOLONE ACETONIDE, dimethicone KIT 20160729 ANDA ANDA088042 Nucare Pharmaceuticals Inc N 20181231 70859-003_3a5b2cd8-5179-169c-e054-00144ff8d46c 70859-003 HUMAN PRESCRIPTION DRUG NuDiclo SoluPak diclofenac sodium, capsaicin KIT 20160729 ANDA ANDA202769 Nucare Pharmaceuticals Inc N 20181231 70859-004_3a5c742f-08cd-524c-e054-00144ff8d46c 70859-004 HUMAN PRESCRIPTION DRUG NuDiclo TabPak DICLOFENAC SODIUM, Capsaicin KIT 20160726 ANDA ANDA074514 Nucare Pharmaceuticals Inc N 20181231 70859-015_4f4416b3-36bb-157e-e054-00144ff88e88 70859-015 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20140103 ANDA ANDA203814 NuCare Pharmaceuticals, Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 70859-020_52911215-d561-1adb-e054-00144ff88e88 70859-020 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 19811019 NDA NDA018569 NuCare Pharmaceuticals, Inc. FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 70859-028_5e75e73e-0613-489d-e053-2a91aa0aa797 70859-028 HUMAN OTC DRUG NuDroxicin pain relief Roll-On METHYL SALICYLATE, MENTHOL, CAPSAICIN LIQUID TOPICAL 20171118 OTC MONOGRAPH NOT FINAL part348 NuCare Pharmaceuticals Inc METHYL SALICYLATE; MENTHOL; CAPSAICIN 250; 60; .25 mg/mL; mg/mL; mg/mL N 20181231 70860-100_5869f2b3-2c5c-4711-8c04-9ad054b938f8 70860-100 HUMAN PRESCRIPTION DRUG Azithromycin azithromycin monohydrate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170101 ANDA ANDA065501 Athenex Pharmaceutical Division, LLC. AZITHROMYCIN MONOHYDRATE 500 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70860-103_64391500-65a5-4d71-9abd-a916f7d7a12d 70860-103 HUMAN PRESCRIPTION DRUG Polymyxin B polymyxin B sulfate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC 20170101 ANDA ANDA207322 Athenex Pharmaceutical Division, LLC. POLYMYXIN B SULFATE 500000 [iU]/1 Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 70860-104_90771c08-6648-49d2-b3cd-514cc2a9d778 70860-104 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170101 ANDA ANDA205694 Athenex Pharmaceutical Division, LLC. VANCOMYCIN HYDROCHLORIDE 500 mg/10mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 70860-105_90771c08-6648-49d2-b3cd-514cc2a9d778 70860-105 HUMAN PRESCRIPTION DRUG Vancomycin Hydrochloride vancomycin hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170101 ANDA ANDA205694 Athenex Pharmaceutical Division, LLC. VANCOMYCIN HYDROCHLORIDE 1 g/20mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] N 20181231 70860-106_a17f552e-fa3c-412a-b294-3fd310eee452 70860-106 HUMAN PRESCRIPTION DRUG Caspofungin Acetate caspofungin acetate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171004 ANDA ANDA207092 Athenex Pharmaceutical Division, LLC. CASPOFUNGIN ACETATE 50 mg/10.8mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 70860-107_a17f552e-fa3c-412a-b294-3fd310eee452 70860-107 HUMAN PRESCRIPTION DRUG Caspofungin Acetate caspofungin acetate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20171004 ANDA ANDA207092 Athenex Pharmaceutical Division, LLC. CASPOFUNGIN ACETATE 70 mg/10.8mL Echinocandin Antifungal [EPC],Lipopeptides [Chemical/Ingredient] N 20181231 70860-200_235721cb-397d-4e44-8299-4373cd9d2497 70860-200 HUMAN PRESCRIPTION DRUG Paclitaxel paclitaxel INJECTION, SOLUTION INTRAVENOUS 20170324 ANDA ANDA207326 Athenex Pharmaceutical Division, LLC. PACLITAXEL 6 mg/mL Microtubule Inhibition [PE],Microtubule Inhibitor [EPC] N 20181231 70860-201_6819e9e1-e1b2-4367-88c0-6e0a8253bd85 70860-201 HUMAN PRESCRIPTION DRUG Oxaliplatin oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20170315 ANDA ANDA207325 Athenex Pharmaceutical Division, LLC. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 70860-204_89fb3bc4-54ab-4c5b-b823-a3c13fa3f601 70860-204 HUMAN PRESCRIPTION DRUG Gemcitabine gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170731 ANDA ANDA204520 Athenex Pharmaceutical Division, LLC. GEMCITABINE HYDROCHLORIDE 200 mg/5mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 70860-205_89fb3bc4-54ab-4c5b-b823-a3c13fa3f601 70860-205 HUMAN PRESCRIPTION DRUG Gemcitabine gemcitabine hydrochloride INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170731 ANDA ANDA204520 Athenex Pharmaceutical Division, LLC. GEMCITABINE HYDROCHLORIDE 1 g/25mL Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] N 20191231 70860-206_a441523a-d500-4e5f-b14f-344d139cbb29 70860-206 HUMAN PRESCRIPTION DRUG Cisplatin cisplatin INJECTION, SOLUTION INTRAVENOUS 20170612 ANDA ANDA207323 Athenex Pharmaceutical Division, LLC. CISPLATIN 1 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 70860-208_93ce419e-e621-46a8-9e35-b818a569a18a 70860-208 HUMAN PRESCRIPTION DRUG Doxorubicin Hydrochloride doxorubicin hydrochloride INJECTION, SOLUTION INTRAVENOUS 20171020 ANDA ANDA209825 Athenex Pharmaceutical Division, LLC. DOXORUBICIN HYDROCHLORIDE 2 mg/mL Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhibitors [MoA] N 20181231 70860-300_e30703b7-a6b3-423d-85e3-36fccc854f5b 70860-300 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate INJECTION, SOLUTION INTRAVENOUS 20170101 ANDA ANDA204205 Athenex Pharmaceutical Division, LLC. METOPROLOL TARTRATE 5 mg/5mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70860-400_e1d19f4b-f03f-4b74-a5d6-2c7223005d30 70860-400 HUMAN PRESCRIPTION DRUG Tranexamic Acid tranexamic acid INJECTION, SOLUTION INTRAVENOUS 20170327 ANDA ANDA207239 Athenex Pharmaceutical Division, LLC. TRANEXAMIC ACID 100 mg/mL Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE] N 20181231 70860-600_35d73dbf-b88b-4d72-8225-3fcbeeb66a06 70860-600 HUMAN PRESCRIPTION DRUG Midazolam midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161214 ANDA ANDA090696 Athenex Pharmaceutical Division, LLC. MIDAZOLAM HYDROCHLORIDE 2 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70860-601_0526cb6a-1ee8-4211-8b03-61b0cf88292f 70860-601 HUMAN PRESCRIPTION DRUG Midazolam midazolam hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20161214 ANDA ANDA090850 Athenex Pharmaceutical Division, LLC. MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 70860-652_f9779a3b-e36c-4e0d-9066-20bb1efd04dc 70860-652 HUMAN PRESCRIPTION DRUG Etomidate etomidate INJECTION, SOLUTION INTRAVENOUS 20170801 ANDA ANDA209058 Athenex Pharmaceutical Division, LLC. ETOMIDATE 2 mg/mL General Anesthesia [PE],General Anesthetic [EPC] N 20181231 70860-700_200c9018-b612-499f-bab4-6ee316101563 70860-700 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170115 ANDA ANDA204216 Athenex Pharmaceutical Division, LLC. KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 70860-701_200c9018-b612-499f-bab4-6ee316101563 70860-701 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine ketorolac tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170115 ANDA ANDA204216 Athenex Pharmaceutical Division, LLC. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 70860-776_f47bc446-25d8-4970-a2af-e14f6ad5e566 70860-776 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170101 ANDA ANDA079224 Athenex Pharmaceutical Division, LLC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 70860-777_f47bc446-25d8-4970-a2af-e14f6ad5e566 70860-777 HUMAN PRESCRIPTION DRUG Ondansetron ondansetron hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20170101 ANDA ANDA090648 Athenex Pharmaceutical Division, LLC. ONDANSETRON HYDROCHLORIDE 2 mg/mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 70860-801_e7b13fa5-b6a9-4ae3-b14b-991ae431e117 70860-801 HUMAN PRESCRIPTION DRUG Terbutaline Sulfate terbutaline sulfate INJECTION, SOLUTION SUBCUTANEOUS 20170222 ANDA ANDA200122 Athenex Pharmaceutical Division, LLC. TERBUTALINE SULFATE 1 mg/mL N 20181231 70867-101_53e8cd39-e710-4287-907c-0411284494fe 70867-101 HUMAN OTC DRUG SPF 30 Body Sunscreen Avobenzone,Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20151103 OTC MONOGRAPH FINAL part352 OJAS, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75; 50; 15; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 70867-102_89765ac8-a3c6-462e-9385-b7533df12a85 70867-102 HUMAN OTC DRUG SPF 15 Lip Conditioner Avobenzone, Homosalate, Octinoxate, Octocrylene CREAM TOPICAL 20151117 OTC MONOGRAPH FINAL part352 OJAS, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 30; 50; 50; 27.5 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 70867-103_0fe4ba03-684e-45a5-96c4-88cfb45d9cb6 70867-103 HUMAN OTC DRUG SPF 30 Body Sunscreen Fragrance Free Avobenzone,Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20151103 OTC MONOGRAPH FINAL part352 OJAS, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75; 50; 15; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 70867-104_a12592de-cb2a-4c52-9d90-aa131bec7833 70867-104 HUMAN OTC DRUG SPF 30 MINERAL SUNSCREEN FACE NECK ZINC OXIDE CREAM TOPICAL 20160726 OTC MONOGRAPH FINAL part352 OJAS, LLC AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 20; 75; 50; 15; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL E 20171231 70868-013_bb1592ee-eeda-434e-b2b8-7f0fde66c46e 70868-013 HUMAN PRESCRIPTION DRUG Triglide fenofibrate TABLET ORAL 20171211 NDA NDA021350 Key Therapeutics, LLC FENOFIBRATE 160 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 70868-120_368e270e-a448-4f75-9d6b-be396eb0ee9b 70868-120 HUMAN PRESCRIPTION DRUG TRIMPEX trimethoprim hydrochloride TRIMETHOPRIM HYDROCHLORIDE SOLUTION ORAL 20171002 NDA NDA074973 Key Therapeutics, LLC TRIMETHOPRIM HYDROCHLORIDE 50 mg/5mL Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 70868-150_948a3a0f-8972-4f07-b6e4-b74261ac6c62 70868-150 HUMAN PRESCRIPTION DRUG Triklo OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED ORAL 20170808 ANDA ANDA204940 Key Therapeutics, LLC OMEGA-3-ACID ETHYL ESTERS 1 g/1 Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 70868-200_ee815be2-8c61-41de-8397-72a0d1908be5 70868-200 HUMAN PRESCRIPTION DRUG Naproxen Naproxen SUSPENSION ORAL 20161111 NDA NDA018965 Key Therapeutics, LLC NAPROXEN 125 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70869-010_7c01b3bc-3bf5-43c6-abfc-15d07ba3018b 70869-010 HUMAN OTC DRUG Secret No 1 ALOE VERA LEAF STICK TOPICAL 20160701 UNAPPROVED DRUG OTHER KJ TRADING, JK GLOBAL(TRADE) ALOE VERA LEAF 2.62 g/35g E 20171231 70873-001_38af9f78-6778-6363-e054-00144ff8d46c 70873-001 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20160728 OTC MONOGRAPH NOT FINAL part333E Simply Clean,LLC ALCOHOL 62 mL/100mL N 20181231 70873-001_38b321ac-0dd9-0df3-e054-00144ff88e88 70873-001 HUMAN OTC DRUG anti-bacterial hand sanitizer ETHYL ALCOHOL GEL TOPICAL 20160728 OTC MONOGRAPH NOT FINAL part333E Simply Clean,LLC ALCOHOL 62 mL/100mL N 20181231 70874-0001_3adfd40f-c41c-14aa-e054-00144ff8d46c 70874-0001 HUMAN OTC DRUG CLBiO Cleansing Pack COCONUT, GRAPE SEED, APRICOT KERNEL, AVOCADO, SCHISANDRA CHINENSIS FRUIT, CASTOR SOAP TOPICAL 20160825 UNAPPROVED DRUG OTHER CLBiO Co., LTD. COCONUT OIL; GRAPE SEED OIL; APRICOT KERNEL OIL; AVOCADO OIL; SCHISANDRA CHINENSIS FRUIT; CASTOR OIL 91.9; .3; .3; .3; .3; .3 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 70874-0002_3adfd40f-c434-14aa-e054-00144ff8d46c 70874-0002 HUMAN OTC DRUG CLBiO Cleansing Pack COCONUT, GRAPE SEED, APRICOT KERNEL, AVOCADO, SCHISANDRA CHINENSIS FRUIT, CASTOR SOAP TOPICAL 20160825 UNAPPROVED DRUG OTHER CLBiO Co., LTD. COCONUT OIL; GRAPE SEED OIL; APRICOT KERNEL OIL; AVOCADO OIL; SCHISANDRA CHINENSIS FRUIT; CASTOR OIL 91.9; .3; .3; .3; .3; .3 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 70874-0003_3aef7416-3d24-388f-e054-00144ff8d46c 70874-0003 HUMAN OTC DRUG CLBiO Cleansing Pack COCONUT, GRAPE SEED, APRICOT KERNEL, AVOCADO, SCHISANDRA CHINENSIS FRUIT, CASTOR SOAP TOPICAL 20160825 UNAPPROVED DRUG OTHER CLBiO Co., LTD. COCONUT OIL; GRAPE SEED OIL; APRICOT KERNEL OIL; AVOCADO OIL; SCHISANDRA CHINENSIS FRUIT; CASTOR OIL 91.9; .3; .3; .3; .3; .3 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 70874-0004_3adfd40f-c43b-14aa-e054-00144ff8d46c 70874-0004 HUMAN OTC DRUG CLBiO Cleansing Pack COCONUT, GRAPE SEED, APRICOT KERNEL, AVOCADO, SCHISANDRA CHINENSIS FRUIT, CASTOR SOAP TOPICAL 20160825 UNAPPROVED DRUG OTHER CLBiO Co., LTD. COCONUT OIL; GRAPE SEED OIL; APRICOT KERNEL OIL; AVOCADO OIL; SCHISANDRA CHINENSIS FRUIT; CASTOR OIL 91.9; .3; .3; .3; .3; .3 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 70875-500_83bd4a15-98b6-444a-a2ea-f64b8bcde8ab 70875-500 HUMAN OTC DRUG SP Pharma ACETAMINOPHEN TABLET ORAL 20160801 OTC MONOGRAPH NOT FINAL part343 Simpor Pharma Sdn Bhd ACETAMINOPHEN 500 mg/583mg N 20181231 70876-001_62171feb-db24-db67-e053-2a91aa0aad8e 70876-001 HUMAN OTC DRUG Tea Tree Oil Tea Tree Oil LIQUID TOPICAL 20160818 UNAPPROVED DRUG OTHER Fujian Meigulin Bio-Technique Co., Ltd. MELALEUCA ALTERNIFOLIA LEAF 1 g/g N 20191231 70876-002_62171feb-db1b-db67-e053-2a91aa0aad8e 70876-002 HUMAN OTC DRUG Tea Tree Oil Tea Tree Oil LIQUID TOPICAL 20160818 UNAPPROVED DRUG OTHER Fujian Meigulin Bio-Technique Co., Ltd. MELALEUCA ALTERNIFOLIA LEAF .95 g/g N 20191231 70877-2324_b7782caf-e5db-4587-97f3-7a5f928f2701 70877-2324 HUMAN PRESCRIPTION DRUG Tranzarel Lidocaine GEL TOPICAL 20170101 UNAPPROVED DRUG OTHER Taleos Pharma LIDOCAINE 4 g/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 70877-5555_e6059e5e-8dee-4b22-af27-9fe11f486899 70877-5555 HUMAN PRESCRIPTION DRUG Dolotranz Lidocaine and Prilocaine KIT 20170101 NDA AUTHORIZED GENERIC NDA019941 Taleos Pharma N 20181231 70878-001_42b09a53-7f78-461b-e054-00144ff88e88 70878-001 HUMAN OTC DRUG Regrowz Homeopathic Scalp Stimulant Allium Cepa Tulsi Tellicherry Bark Methi Seeds and Leaves SYRUP TOPICAL 20160728 UNAPPROVED HOMEOPATHIC Regrowz Ltd ALLIUM CEPA WHOLE; FENUGREEK LEAF; HOLY BASIL LEAF; HOLARRHENA PUBESCENS BARK .1; .1; .1; .1 [hp_X]/25mg; [hp_X]/25mg; [hp_X]/25mg; [hp_X]/25mg N 20181231 70878-002_60dd6068-393e-6b1f-e053-2991aa0a4e01 70878-002 HUMAN OTC DRUG Regrowz Homothetic Restoration Serum Men/women Allium Cepa Tulsi Tellicherry Bark Methi Seeds and Leaves SYRUP TOPICAL 20170413 UNAPPROVED HOMEOPATHIC Regrowz Ltd ALLIUM CEPA WHOLE; FENUGREEK LEAF; HOLY BASIL LEAF; HOLARRHENA PUBESCENS BARK .1; .1; .1; .1 [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL; [hp_X]/25mL N 20181231 70879-752_4807f842-0961-0320-e054-00144ff88e88 70879-752 HUMAN OTC DRUG Geneva Naturals Advanced Anti-Aging with Sunscreen SPF 20 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20160731 OTC MONOGRAPH NOT FINAL part352 Geneva Naturals USA, Llc AVOBENZONE; OCTINOXATE; OCTISALATE 30; 50; 30 mg/mL; mg/mL; mg/mL N 20181231 70879-753_4807fb60-8cdf-6e61-e054-00144ff8d46c 70879-753 HUMAN OTC DRUG Geneva Naturals Advanced Anti-Aging with Sunscreen SPF 20 Unscented AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20160731 OTC MONOGRAPH NOT FINAL part352 Geneva Naturals USA, Llc AVOBENZONE; OCTINOXATE; OCTISALATE 30; 50; 30 mg/mL; mg/mL; mg/mL N 20181231 70879-824_4ea12b96-d0c6-641c-e054-00144ff88e88 70879-824 HUMAN OTC DRUG Advanced Anti Aging Unscented with sunscreen SPF 20 AVOBENZONE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20170503 OTC MONOGRAPH NOT FINAL part352 Geneva Naturals USA, LLC AVOBENZONE; OCTINOXATE; OCTISALATE 30; 50; 30 mg/g; mg/g; mg/g N 20181231 70880-112_489301eb-95b6-468e-a00f-5a92189cb5f4 70880-112 HUMAN PRESCRIPTION DRUG Monsels Solution Ferric Subsulfate SOLUTION TOPICAL 20160801 UNAPPROVED DRUG OTHER MedGyn Products, Inc. FERRIC SUBSULFATE 20 g/100mL Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] E 20171231 70881-100_fed2a655-dafe-434a-9685-5c840469e84e 70881-100 HUMAN OTC DRUG Sit Clean Benzalkonium Chloride CLOTH TOPICAL 20160823 OTC MONOGRAPH NOT FINAL part333A Sit Clean BENZALKONIUM CHLORIDE .13 g/g N 20181231 70882-101_c00168f4-381d-4429-9fa1-2c0c4c57c604 70882-101 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate TABLET, FILM COATED ORAL 19840911 ANDA ANDA062505 Cambridge Therapeutics Technologies, LLC DOXYCYCLINE HYCLATE 100 mg/1 N 20181231 70882-102_00bf7b50-9eb0-4956-8c4e-e90abd4d65b3 70882-102 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120529 ANDA ANDA077575 Cambridge Therapeutics Technologies, LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70882-103_84eceb98-cd51-4392-b808-371bb0bc420d 70882-103 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150523 ANDA ANDA075994 Cambridge Therapeutics Technologies, LLC LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70882-104_84eceb98-cd51-4392-b808-371bb0bc420d 70882-104 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20150523 ANDA ANDA075994 Cambridge Therapeutics Technologies, LLC LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70882-105_e083276f-e247-4e50-a279-5b9f2923df71 70882-105 HUMAN PRESCRIPTION DRUG Pioglitazone and metformin Pioglitazone and metformin TABLET, FILM COATED ORAL 20130502 ANDA ANDA091273 Cambridge Therapeutics Technologies, LLC PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE 15; 500 mg/1; mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70882-106_00bf7b50-9eb0-4956-8c4e-e90abd4d65b3 70882-106 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium atorvastatin calcium TABLET, FILM COATED ORAL 20120529 ANDA ANDA077575 Cambridge Therapeutics Technologies, LLC ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70882-107_361cff1c-8f35-4130-9fca-7b0cc791b6eb 70882-107 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110718 ANDA ANDA065507 Cambridge Therapeutics Technologies, LLC AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70882-109_fa29e781-e2ee-4788-ae48-d1f8fbba115b 70882-109 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Cambridge Therapeutics Technologies, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70882-110_84eceb98-cd51-4392-b808-371bb0bc420d 70882-110 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20150523 ANDA ANDA075994 Cambridge Therapeutics Technologies, LLC LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 70882-111_f0063b1e-af9e-474d-96b9-0b3aa1a37ea2 70882-111 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20050823 ANDA ANDA065189 Cambridge Therapeutics Technologies, LLC AMOXICILLIN; CLAVULANATE POTASSIUM 250; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 70882-112_d63937ce-2eb3-4ae2-8a4d-40a2e935d06f 70882-112 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium amoxicillin and clavulanate potassium TABLET, FILM COATED ORAL 20021127 ANDA ANDA065117 Cambridge Therapeutics Technologies, LLC AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20181231 70882-113_af0ae6a3-1435-40dd-a62a-ce533791a28c 70882-113 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Cambridge Therapeutics Technologies, LLC AMOXICILLIN 250 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 70882-114_af0ae6a3-1435-40dd-a62a-ce533791a28c 70882-114 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Cambridge Therapeutics Technologies, LLC AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 70882-115_2463e68f-4f8c-4334-a45e-8204a53d9f83 70882-115 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19951130 ANDA ANDA074394 Cambridge Therapeutics Technologies, LLC DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70882-116_782ff485-7564-4446-8a45-4b121c59287c 70882-116 HUMAN PRESCRIPTION DRUG Clopidogrel clopidogrel bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA076274 Cambridge Therapeutics Technologies, LLC CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 70882-117_886eec2f-5b6d-4fce-bc0d-a10e445f041f 70882-117 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Cambridge Therapeutics Technologies, LLC PREDNISONE 5 mg/1 N 20181231 70882-118_361cff1c-8f35-4130-9fca-7b0cc791b6eb 70882-118 HUMAN PRESCRIPTION DRUG Azithromycin Dihydrate azithromycin TABLET, FILM COATED ORAL 20110718 ANDA ANDA065509 Cambridge Therapeutics Technologies, LLC AZITHROMYCIN DIHYDRATE 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 70882-119_fa29e781-e2ee-4788-ae48-d1f8fbba115b 70882-119 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Cambridge Therapeutics Technologies, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70882-120_fa29e781-e2ee-4788-ae48-d1f8fbba115b 70882-120 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Cambridge Therapeutics Technologies, LLC ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 70882-122_2efeb138-afcf-4c6b-a872-8522c492deb4 70882-122 HUMAN OTC DRUG AspirinLow Dose Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 Cambridge Therapeutics Technologies, LLC ASPIRIN 81 mg/1 N 20181231 70882-123_126c5279-0ac1-4ed8-8c0f-b9084e3d7bb2 70882-123 HUMAN PRESCRIPTION DRUG Clopidogrel Kit Clopidogrel Kit KIT 20170701 ANDA ANDA076274 Cambridge Therapeutics Technologies, LLC N 20181231 70882-124_2254915d-44f2-4c8c-9bc9-5929b99eda7f 70882-124 HUMAN PRESCRIPTION DRUG Metformin HCl Metformin HCl TABLET ORAL 20170206 ANDA ANDA090564 Cambridge Therapeutics Technologies, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70882-125_61b6dfd4-ea72-40f3-b4cd-0a51e8a810a6 70882-125 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20110131 ANDA ANDA091184 Cambridge Therapeutics Technologies, LLC METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70882-126_7805423f-2b01-4c26-b082-b9ccda3f3659 70882-126 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Cambridge Therapeutics Technologies, LLC METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70882-127_7805423f-2b01-4c26-b082-b9ccda3f3659 70882-127 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Cambridge Therapeutics Technologies, LLC METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70882-128_b30b3f90-b9d8-4110-b0a8-5c18b8969832 70882-128 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Cambridge Therapeutics Technologies, LLC DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70882-129_79f328f1-ce1a-435e-9540-6e14374989d6 70882-129 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20160201 ANDA ANDA206827 Cambridge Therapeutics Technologies, LLC CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70882-130_0aa5cb55-934d-4eb1-9c3c-b986053a97da 70882-130 HUMAN PRESCRIPTION DRUG Metronidazole250 mg 250 mg Metronidazole TABLET, FILM COATED ORAL 20160613 ANDA ANDA070040 Cambridge Therapeutics Technologies, LLC METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 70882-131_1835a76b-e6ee-4e9a-b35d-9c39c6cfcbf3 70882-131 HUMAN PRESCRIPTION DRUG Metronidazole500 mg 500 mg Metronidazole TABLET, FILM COATED ORAL 20160613 ANDA ANDA070039 Cambridge Therapeutics Technologies, LLC METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 70882-132_6478f769-c2cc-403a-ba3a-17fd73ac84c6 70882-132 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Cambridge Therapeutics Technologies, LLC METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70882-133_6478f769-c2cc-403a-ba3a-17fd73ac84c6 70882-133 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Cambridge Therapeutics Technologies, LLC METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 70884-101_132b48fc-b3c3-4cd3-8b8c-89b1dff3992f 70884-101 HUMAN OTC DRUG TROPICSURF EXTREME PROTECTION SPF30-ULTRA TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20160803 OTC MONOGRAPH FINAL part352 PALMER SURF LLC (DBA X3EMBRANDS) TITANIUM DIOXIDE; ZINC OXIDE 4.5; 8.7 g/100mL; g/100mL N 20181231 70884-102_7d9cd804-b429-4a20-b4cd-be3b07900e4e 70884-102 HUMAN OTC DRUG TROPICSURF EXTREME PROTECTION SPF50 OCTOCRYLENE, ZINC OXIDE LOTION TOPICAL 20160804 OTC MONOGRAPH FINAL part352 PALMER SURF LLC (DBA X3EMBRANDS) OCTOCRYLENE; ZINC OXIDE 7.5; 10.5 g/100mL; g/100mL N 20181231 70888-001_62171feb-db12-db67-e053-2a91aa0aad8e 70888-001 HUMAN OTC DRUG Antibacterial Wet Wipes benzalkonium chloride SWAB TOPICAL 20150806 OTC MONOGRAPH NOT FINAL part333A SHAOXING BAIXUN HYGIENE PRODUCTS CO.,LTD BENZALKONIUM CHLORIDE .13 g/100g N 20191231 70889-100_40d299c7-153c-08c1-e054-00144ff88e88 70889-100 HUMAN OTC DRUG Edge Cutimal Cat Whitening Mask Niacinamide Face Mask PATCH TOPICAL 20161101 UNAPPROVED DRUG OTHER Oneskin Cosmetics Co., Ltd. NIACINAMIDE .5 g/25g N 20181231 70889-200_40d3b09a-1521-373f-e054-00144ff8d46c 70889-200 HUMAN OTC DRUG Edge Cutimal Tiger Anti-Wrinkle Mask Adenosine Face Mask PATCH TOPICAL 20161101 UNAPPROVED DRUG OTHER Oneskin Cosmetics Co., Ltd. ADENOSINE .01 g/25g N 20181231 70891-201_5e86319a-5064-167d-e053-2991aa0a0087 70891-201 HUMAN OTC DRUG Escozine HP RHOPALURUS PRINCEPS VENOM, Bryonia Alba,Echinacea purpurea LIQUID ORAL 20160930 UNAPPROVED HOMEOPATHIC Medolife Corporation ECHINACEA PURPUREA; BRYONIA ALBA ROOT; RHOPALURUS PRINCEPS VENOM 10; 30; 3 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL N 20181231 70893-0011_39d07486-99b8-5c06-e054-00144ff8d46c 70893-0011 HUMAN OTC DRUG Creomulsion Cough Medicine Adult Formula DEXTROMETHORPHAN HYDROBROMIDE SYRUP ORAL 20160811 OTC MONOGRAPH FINAL part341 Socius Care, LLC DEXTROMETHORPHAN HYDROBROMIDE 20 mg/15mL N 20181231 70893-0012_39d0e96c-1cc4-4961-e054-00144ff88e88 70893-0012 HUMAN OTC DRUG Creomulsion For Children DEXTROMETHORPHAN HYDROBROMIDE SYRUP ORAL 20160811 OTC MONOGRAPH FINAL part341 Socius Care, LLC DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL N 20181231 70894-010_8c40d4d9-c3a6-48d3-81c8-b7c01927864a 70894-010 HUMAN OTC DRUG The All Medicare V PLA Synergy Moisturizing Mask Glycerin PATCH TOPICAL 20160701 UNAPPROVED DRUG OTHER TAENAM MEDICOS CO., LTD GLYCERIN 1.84 g/23mL E 20171231 70894-020_573d47b3-4169-4f92-8561-5078743acdd4 70894-020 HUMAN OTC DRUG The All Medicare V PLA Synergy Whitening Mask Glycerin, Niacinamide PATCH TOPICAL 20160701 UNAPPROVED DRUG OTHER TAENAM MEDICOS CO., LTD GLYCERIN; NIACINAMIDE 1.85; .46 g/23mL; g/23mL E 20171231 70894-030_1f465097-395e-45f8-9a12-9fe50f598b0f 70894-030 HUMAN OTC DRUG The All Medicare V PLA Synergy Anti Wrinkle Face And Neck Mask Glycerin, Adenosine PATCH TOPICAL 20160701 UNAPPROVED DRUG OTHER TAENAM MEDICOS CO., LTD GLYCERIN; ADENOSINE 2.18; .01 g/27mL; g/27mL E 20171231 70894-040_0c10023d-d254-47d0-b284-77c36693e9f4 70894-040 HUMAN OTC DRUG TAMHADA Synergy Moisturizing Mask Glycerin PATCH TOPICAL 20161001 UNAPPROVED DRUG OTHER TAENAM MEDICOS CO., LTD GLYCERIN 1.84 g/23g E 20171231 70894-050_0198e532-7421-4781-b216-5b52f6847b9f 70894-050 HUMAN OTC DRUG TAMHADA Synergy Whitening Mask Glycerin, Niacinamide PATCH TOPICAL 20161001 UNAPPROVED DRUG OTHER TAENAM MEDICOS CO., LTD GLYCERIN; NIACINAMIDE 1.85; .46 g/23g; g/23g E 20171231 70894-060_fd71eb7d-9871-474b-b57a-a50714d8161c 70894-060 HUMAN OTC DRUG TAMHADA Synergy Anti Wrinkle Face And Neck Mask Glycerin, Adenosine PATCH TOPICAL 20161001 UNAPPROVED DRUG OTHER TAENAM MEDICOS CO., LTD GLYCERIN; ADENOSINE 2.18; .01 g/27g; g/27g E 20171231 70897-001_64285695-6b43-f721-e053-2a91aa0a8c5c 70897-001 HUMAN OTC DRUG First Aid Burn Cream Lidocaine CREAM TOPICAL 20160809 OTC MONOGRAPH NOT FINAL part348 Davemed Healthcare Co., Ltd LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE .5; .13 g/100g; g/100g N 20191231 70897-002_64285695-6b4e-f721-e053-2a91aa0a8c5c 70897-002 HUMAN OTC DRUG Eye Wash Saline water sodium chloride SOLUTION OPHTHALMIC 20160809 OTC MONOGRAPH FINAL part349 Davemed Healthcare Co., Ltd. SODIUM CHLORIDE; WATER .9; 99.01 mg/100mL; mg/100mL N 20191231 70897-003_39d34a43-a673-6e9c-e054-00144ff8d46c 70897-003 HUMAN OTC DRUG Triple Antiobiotic Triple Antibiotic Ointment OINTMENT TOPICAL 20160811 OTC MONOGRAPH FINAL part333B Davemed Healthcare Co., Ltd. POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC 5000; 5; 400 [iU]/g; mg/g; [iU]/g E 20171231 70899-755_47f5441d-e704-0485-e054-00144ff8d46c 70899-755 HUMAN OTC DRUG DolFrost Cool and Soothing Roll-On MENTHOL LIQUID TOPICAL 20160914 OTC MONOGRAPH NOT FINAL part348 Dermatech Laboratories LLC MENTHOL 20 mg/mL N 20181231 70900-202_124d4a13-6c8d-4d66-9284-33d7946c7c0f 70900-202 HUMAN OTC DRUG SUNSHIELD SPF-30 OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20160804 OTC MONOGRAPH FINAL part352 CLINICAL CARE SKIN SOLUTIONS, INC OCTINOXATE; OCTISALATE; ZINC OXIDE 6.9; 3; 4 g/100mL; g/100mL; g/100mL N 20181231 70903-100_12b7d1ac-6853-4d8b-bdce-7b7a3448fa34 70903-100 HUMAN OTC DRUG Ear Drying Isopropyl alcohol, Glycerin LIQUID AURICULAR (OTIC) 20161001 OTC MONOGRAPH FINAL part344 Starkey Hearing Technologies ISOPROPYL ALCOHOL 95 g/100mL N 20181231 70903-200_55c594df-cdee-47fb-ada5-62a74368f6b1 70903-200 HUMAN OTC DRUG Ear Wax Removal Carbamide Peroxide LIQUID AURICULAR (OTIC) 20161001 OTC MONOGRAPH FINAL part344 Starkey Hearing Technologies CARBAMIDE PEROXIDE 6.5 g/100mL N 20181231 70903-200_d249b1a6-a353-41a5-b83f-29f7268e0dba 70903-200 HUMAN OTC DRUG Ear Wax Removal Carbamide Peroxide LIQUID AURICULAR (OTIC) 20161001 OTC MONOGRAPH FINAL part344 Starkey Hearing Technologies CARBAMIDE PEROXIDE 6.5 g/100mL N 20181231 70903-300_973195be-2ad9-4958-99ed-be341174fe4e 70903-300 HUMAN OTC DRUG EarAche BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, and SULFUR LIQUID AURICULAR (OTIC) 20161001 UNAPPROVED DRUG OTHER Starkey Hearing Technologies BELLADONNA LEAF; CALCIUM CARBONATE; CHAMOMILE; LYCOPODIUM CLAVATUM SPORE; ANEMONE PATENS; SULFUR 30; 30; 30; 30; 30; 30 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 70904-756_48301d78-e812-5c28-e054-00144ff8d46c 70904-756 HUMAN OTC DRUG Cajun Hot Ice Muscle and Joint Pain Rub MENTHOL, CAMPHOR, CAPSAICIN GEL TOPICAL 20160812 OTC MONOGRAPH NOT FINAL part348 Cajun Therapeutics, LLC CAMPHOR (NATURAL); MENTHOL; CAPSAICIN 30; 90; .25 mg/g; mg/g; mg/g N 20181231 70905-0001_39d7a5d2-678d-4c08-e054-00144ff8d46c 70905-0001 HUMAN OTC DRUG DR.ALTHEA WATER GLOW AQUA PROPOLIS WAX CREAM TOPICAL 20160811 UNAPPROVED DRUG OTHER Dr. Althea PROPOLIS WAX .1 g/100mL N 20181231 70905-0002_39d7a5d2-6797-4c08-e054-00144ff8d46c 70905-0002 HUMAN OTC DRUG DR.ALTHEA POWER WHITENING GLUTATHIONE NIACINAMIDE CREAM TOPICAL 20160811 UNAPPROVED DRUG OTHER Dr. Althea NIACINAMIDE 2 g/100mL N 20181231 70905-0003_39d7a5d2-67a1-4c08-e054-00144ff8d46c 70905-0003 HUMAN OTC DRUG DR.ALTHEA HYDRATION BOOSTING SERUM DIMETHICONE CREAM TOPICAL 20160811 OTC MONOGRAPH FINAL part347 Dr. Althea DIMETHICONE 2 g/100mL N 20181231 70905-0004_39d50822-8e8f-6146-e054-00144ff88e88 70905-0004 HUMAN OTC DRUG Premium Dr. Althea Essential Skin Conditioner Silk Mask Glycerin LIQUID TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part347 Dr. Althea GLYCERIN 5 g/100g N 20181231 70905-0005_39d8667a-dfb3-076e-e054-00144ff8d46c 70905-0005 HUMAN OTC DRUG Premium Dr. Althea Squalane Silk Mask Glycerin LIQUID TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part347 Dr. Althea GLYCERIN 5 g/100g N 20181231 70905-0006_39d89040-4e4c-0eb5-e054-00144ff8d46c 70905-0006 HUMAN OTC DRUG Premium Dr. Althea Water Glow Skin Renewal Hydrogel Mask Adenosine, Niacinamide LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER Dr. Althea NIACINAMIDE; ADENOSINE 2; .04 g/100g; g/100g N 20181231 70905-0007_39da1074-8fe9-5711-e054-00144ff8d46c 70905-0007 HUMAN OTC DRUG Premium Dr. Althea Power Whitening Glutathione Mask Adenosine, Niacinamide LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER Dr. Althea NIACINAMIDE; ADENOSINE 2; .04 g/100g; g/100g N 20181231 70905-0008_3c46e2e4-92ca-35f8-e054-00144ff88e88 70905-0008 HUMAN OTC DRUG Dr. Althea Foaming Cleanser and Bubble O2 Mask Glycerin GEL TOPICAL 20160912 UNAPPROVED DRUG OTHER Dr. Althea GLYCERIN .57 g/100mL N 20181231 70905-0009_3c456191-aec6-4cae-e054-00144ff88e88 70905-0009 HUMAN OTC DRUG Dr.Althea Herb Therapy Velvet Mask Glycerin LIQUID TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part347 Dr. Althea GLYCERIN 2.53045 g/100g N 20181231 70905-0010_3e911ad6-52b1-5cd3-e054-00144ff88e88 70905-0010 HUMAN OTC DRUG Dr.Althea To Be Eyeconic Eye Serum DIMETHICONE CREAM TOPICAL 20160811 OTC MONOGRAPH FINAL part347 Dr. Althea DIMETHICONE 6.0192 g/100mL N 20181231 70905-0011_449b501c-ccba-7339-e054-00144ff88e88 70905-0011 HUMAN OTC DRUG Dr. Althea Water Glow Aqua Ampoule Mask Adenosine LIQUID TOPICAL 20161201 UNAPPROVED DRUG OTHER Dr. Althea ADENOSINE .04 g/100g N 20181231 70905-0012_449e09ce-cfc1-5656-e054-00144ff8d46c 70905-0012 HUMAN OTC DRUG Dr. Althea Pore-Control Charcoal Mask Adenosine LIQUID TOPICAL 20161201 UNAPPROVED DRUG OTHER Dr. Althea ADENOSINE .04 g/100g N 20181231 70905-0013_4c0089fb-b78f-5edb-e054-00144ff88e88 70905-0013 HUMAN OTC DRUG DR.ALTHEA DRINK UP ESSENTIAL MIST GLYCERIN LIQUID TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part347 Dr. Althea GLYCERIN 10 g/100mL N 20181231 70905-0014_4c3ae1b2-ada8-5899-e054-00144ff88e88 70905-0014 HUMAN OTC DRUG DR.ALTHEA CITRUS AND HONEY DEEPLY CLEANSING BALM CITRUS JUNOS FRUIT, HONEY CREAM TOPICAL 20170301 UNAPPROVED DRUG OTHER Dr. Althea CITRUS JUNOS FRUIT; HONEY .01; .01 g/100mL; g/100mL N 20181231 70905-0015_4c3a0ff2-8c9d-5a83-e054-00144ff8d46c 70905-0015 HUMAN OTC DRUG DR.ALTHEA AURORA COVER CUSHION 21 TITANIUM DIOXIDE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE, ZINC OXIDE, NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170403 UNAPPROVED DRUG OTHER Dr. Althea OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; ADENOSINE; NIACINAMIDE; OCTOCRYLENE; ZINC OXIDE 7; 9.00552; 4.8; .04; 2; 2; 2 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70905-0016_4d1a3793-5a97-4aec-e054-00144ff8d46c 70905-0016 HUMAN OTC DRUG MIDNIGHT CINEMA LA BELLE IN ROUGE 01. DANCING IN MONACO DIMETHICONE LIPSTICK TOPICAL 20170401 UNAPPROVED DRUG OTHER Dr. Althea DIMETHICONE 7.4 g/100g N 20181231 70907-001_42c2e779-694e-4506-8fc9-7eb30a87cc64 70907-001 HUMAN OTC DRUG Numb Skin Lidocaine Cream CREAM TOPICAL 20160901 OTC MONOGRAPH FINAL part346 Seenext Venture Ltd LIDOCAINE 5 mg/30g N 20181231 70907-002_704bee34-3d52-4259-9496-2cd27214f4c3 70907-002 HUMAN OTC DRUG Numb Skin Lidocaine and Benzethonium Chloride Cream CREAM TOPICAL 20170911 OTC MONOGRAPH NOT FINAL part348 Seenext Venture Ltd LIDOCAINE; BENZETHONIUM CHLORIDE 4; .25 mg/50g; mg/50g N 20181231 70908-010_a37d7e0f-4484-4d64-ae85-7535dc6d1b25 70908-010 HUMAN OTC DRUG WHITE FLOWER CHEOLLASOO FOI L MASK SHEET Glycerin PATCH TOPICAL 20161101 UNAPPROVED DRUG OTHER MeFactory Co., Ltd. GLYCERIN 1.57 g/35g N 20181231 70908-020_5f23c69a-302d-490f-902f-4611c2cc73e4 70908-020 HUMAN OTC DRUG WHITE FLOWER MUNG BEAN FOI L MASK SHEET Glycerin PATCH TOPICAL 20161101 UNAPPROVED DRUG OTHER MeFactory Co., Ltd. GLYCERIN 1.57 g/35g N 20181231 70908-030_4d782114-1ed8-456c-a9fc-77dfb7d6b971 70908-030 HUMAN OTC DRUG WHITE FLOWER PIG COLLAGEN FOI L MASK SHEET Glycerin PATCH TOPICAL 20161101 UNAPPROVED DRUG OTHER MeFactory Co., Ltd. GLYCERIN 1.57 g/35g N 20181231 70908-040_bb9a5186-a864-4390-a50f-11458f8fb7ed 70908-040 HUMAN OTC DRUG MEFACTORY PIG COLLAGEN 1STEP PIGGY NOSE PACK Kaolin PATCH TOPICAL 20161201 UNAPPROVED DRUG OTHER MeFactory Co., Ltd. KAOLIN .002 g/.2g N 20181231 70908-050_9657e2e6-8e08-4856-83f7-74c04073ca3a 70908-050 HUMAN OTC DRUG MEFACTORY 3STEP PIGGY NOSE PACK STEP 01 PORE HEATING SHEET Glycerin PATCH TOPICAL 20161201 UNAPPROVED DRUG OTHER MeFactory Co., Ltd. GLYCERIN .13 g/3g N 20181231 70908-060_7f1e6e32-3034-4acc-b5f5-e1353174bc82 70908-060 HUMAN OTC DRUG MEFACTORY 3STEP PIGGY NOSE PACK STEP 02 BLACKHEAD CLEAR SHEET Witch Hazel PATCH TOPICAL 20161201 OTC MONOGRAPH FINAL part347 MeFactory Co., Ltd. WITCH HAZEL .016 g/2g N 20181231 70908-070_5fe8f7a8-3f54-4631-8f6c-e9d624f532b1 70908-070 HUMAN OTC DRUG MEFACTORY 3STEP PIGGY NOSE PACK STEP 03 PORE TIGHTENING SHEET Witch Hazel PATCH TOPICAL 20161201 OTC MONOGRAPH FINAL part347 MeFactory Co., Ltd. WITCH HAZEL .09 g/3g N 20181231 70908-080_abafa715-24cd-4ff1-abc4-3d4ddf5c1148 70908-080 HUMAN OTC DRUG Mefactory 3Step Piggy Nose Pore Strip Step 01 Pore Opening Sheet Adenosine PATCH TOPICAL 20170201 UNAPPROVED DRUG OTHER MeFactory Co., Ltd. ADENOSINE .6 mg/3g N 20181231 70908-090_9451c712-4554-4fb4-94ec-5d9037afa457 70908-090 HUMAN OTC DRUG Mefactory 3Step Piggy Nose Pore Strip Step 02 Blackhead Clearing Sheet Witch Hazel PATCH TOPICAL 20170201 OTC MONOGRAPH FINAL part347 MeFactory Co., Ltd. WITCH HAZEL .02 mg/.2g N 20181231 70908-100_1c97eb44-2652-4e09-ae26-11027e85686a 70908-100 HUMAN OTC DRUG Mefactory 3Step Piggy Nose Pore Strip Step 03 Pore Tightening Sheet Witch Hazel PATCH TOPICAL 20170201 OTC MONOGRAPH FINAL part347 MeFactory Co., Ltd. WITCH HAZEL .3 mg/3g N 20181231 70908-110_f5b0b409-1def-4265-be86-cffa44b1927c 70908-110 HUMAN OTC DRUG BODYHOLIC RED POTION HAIR AND BODY MIST Glycerin SPRAY TOPICAL 20170401 UNAPPROVED DRUG OTHER MeFactory Co., Ltd. GLYCERIN .5 g/50mL N 20181231 70908-120_884e3a0c-c552-4e6f-bf2c-8c876278a302 70908-120 HUMAN OTC DRUG BODYHOLIC SKY POTION HAIR AND BODY MIST Glycerin SPRAY TOPICAL 20170401 UNAPPROVED DRUG OTHER MeFactory Co., Ltd. GLYCERIN .5 g/50mL N 20181231 70908-130_6b21ea7b-c81a-4095-929b-d46d5a83440b 70908-130 HUMAN OTC DRUG BODYHOLIC YELLOW POTION HAIR AND BODY MIST Glycerin SPRAY TOPICAL 20170401 UNAPPROVED DRUG OTHER MeFactory Co., Ltd. GLYCERIN .5 g/50mL N 20181231 70908-140_16a78d98-c28c-4108-8f1a-52a7a5860d0b 70908-140 HUMAN OTC DRUG Mefactory Piggy Nose Pore Strip Witch Hazel PATCH TOPICAL 20170701 OTC MONOGRAPH FINAL part347 MeFactory Co., Ltd. WITCH HAZEL .02 mg/.2g N 20181231 70908-150_3efcca35-e86e-49b6-9f6f-d375ca6af31e 70908-150 HUMAN OTC DRUG Mefactory Piggy Peeling Pad Glycerin PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER MeFactory Co., Ltd. GLYCERIN .14 g/7g N 20181231 70908-160_7abee1b2-b0d5-4e0b-8855-c01825fa4e63 70908-160 HUMAN OTC DRUG Mefactory Cement Peel off Pack Glycerin GEL TOPICAL 20170701 UNAPPROVED DRUG OTHER MeFactory Co., Ltd. GLYCERIN 4.8 g/120mL N 20181231 70908-180_bce401c1-d87a-4997-81b5-736a4987b861 70908-180 HUMAN OTC DRUG Mefactory Super Light Cleansing Witch Hazel OIL TOPICAL 20171201 OTC MONOGRAPH FINAL part347 MeFactory Co., Ltd. WITCH HAZEL .002 g/200mL N 20181231 70908-190_55b249fb-4aae-49c8-b1eb-97241aa8faf4 70908-190 HUMAN OTC DRUG Mefactory Super Clear Lip And Eye Remover CYCLOMETHICONE 5 LIQUID TOPICAL 20171201 UNAPPROVED DRUG OTHER MeFactory Co., Ltd. CYCLOMETHICONE 5 80 g/200mL N 20181231 70908-200_d18f8736-a106-4e7f-a303-790e5bdbede2 70908-200 HUMAN OTC DRUG Mefactory Super Deep Cleansing Foa m Witch Hazel CREAM TOPICAL 20171201 OTC MONOGRAPH FINAL part347 MeFactory Co., Ltd. WITCH HAZEL .001 g/120g N 20191231 70909-757_49854957-97dc-19fb-e054-00144ff8d46c 70909-757 HUMAN OTC DRUG SE Sport Endurance Pain Freeze Recovery MENTHOL GEL TOPICAL 20160813 OTC MONOGRAPH NOT FINAL part348 Sport Endurance, Inc MENTHOL 140 mg/mL N 20181231 70911-110_1b38242c-6a8c-473c-aae7-41592033f4cd 70911-110 HUMAN OTC DRUG REFINE Complexion Clearing Pads salicylic acid SWAB TOPICAL 20170101 OTC MONOGRAPH FINAL part333D SCHWEIGER DERMATOLOGY GROUP SALICYLIC ACID 20 mg/mL E 20171231 70911-112_6ef35a75-9c1c-4318-9656-17bec16f68ca 70911-112 HUMAN OTC DRUG REFORM BENZOYL PEROXIDE CREAM TOPICAL 20170101 OTC MONOGRAPH FINAL part333D SCHWEIGER DERMATOLOGY GROUP BENZOYL PEROXIDE 52.5 mg/mL E 20171231 70911-114_8779717b-65a2-4d1e-a288-e53c2add7993 70911-114 HUMAN OTC DRUG CLARIFY BOTANICAL CLARIFYING WASH SALICYLIC ACID GEL TOPICAL 20170101 OTC MONOGRAPH FINAL part333D SCHWEIGER DERMATOLOGY GROUP SALICYLIC ACID 20 mg/mL E 20171231 70912-100_3c609ab8-c2eb-3e5f-e054-00144ff88e88 70912-100 HUMAN OTC DRUG White Lie Niacinamide, Adenosine Cream CREAM TOPICAL 20160913 UNAPPROVED DRUG OTHER Samsung Cosmetics Co., LTD. ADENOSINE; NIACINAMIDE .02; 1 g/50g; g/50g N 20181231 70913-001_58087366-a017-4d52-8389-90a99525509e 70913-001 HUMAN OTC DRUG CODE BROWN ISOPROPYL ALCOHOL LIQUID TOPICAL 20160625 OTC MONOGRAPH NOT FINAL part333A Ladidah Essentials, Llc ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 70914-000_fb74b13b-94b7-475e-b45b-7065f29e9a1f 70914-000 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20170601 ANDA ANDA077336 Hudson Scientific LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70914-002_27deaa4d-72b2-4852-b857-69a056ad383b 70914-002 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040616 ANDA ANDA076172 Hudson Scientific LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 70914-006_b30d8e97-f602-4b5a-97aa-1e132d3560f4 70914-006 HUMAN PRESCRIPTION DRUG DM2 Metformin Hydrochloride KIT 20170616 ANDA ANDA077336 Hudson Scientific LLC N 20181231 70914-011_a9c5e7c5-04e9-498e-ae3d-fc07bf4797a5 70914-011 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine TABLET, FILM COATED ORAL 20170104 ANDA ANDA090478 Hudson Scientific LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70914-012_fb01bfe0-ebbb-4d77-a9f3-a446cef6a9fd 70914-012 HUMAN PRESCRIPTION DRUG CycloTENS Starter Pak Cyclobenzaprine KIT 20170123 ANDA ANDA090478 Hudson Scientific LLC N 20181231 70914-013_afaf346c-87af-4b77-a600-9733ca33568c 70914-013 HUMAN PRESCRIPTION DRUG CycloTENS Refill Pak Cyclobenzaprine KIT 20170123 ANDA ANDA090478 Hudson Scientific LLC N 20181231 70919-001_98c8ed4d-2427-4e2e-8462-ae2c7ac792fb 70919-001 HUMAN OTC DRUG Ultra Shade Sunscreen SPF 30 Taheri MD Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20160817 OTC MONOGRAPH FINAL part352 LA LASER CENTE, PC, CALIFORNIA PROFESSIONAL MEDICAL CORP TITANIUM DIOXIDE; ZINC OXIDE 5; 10 g/100mL; g/100mL N 20181231 70920-010_64ee7891-3cd3-4179-87ea-14392f2faa07 70920-010 HUMAN OTC DRUG Jayjun Baby Pure Shining Mask Step1 Blooming Essence Glycerin LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. GLYCERIN .1 g/1.5mL N 20181231 70920-020_97c87227-e084-4cec-a28b-f07caba0f60f 70920-020 HUMAN OTC DRUG Jayjun Baby Pure Shining Mask Step2 Baby Pure Shining Mask Glycerin, Niacinamide, Allantoin PATCH TOPICAL 20160801 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. GLYCERIN; NIACINAMIDE; ALLANTOIN 1.2; .5; .02 g/25mL; g/25mL; g/25mL N 20181231 70920-030_76eb9ba2-e164-40dd-9dfa-92421163ac20 70920-030 HUMAN OTC DRUG Jayjun Baby Pure Shining Mask Step3 Hydro Eye Glycerin CREAM TOPICAL 20160801 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. GLYCERIN .06 g/1.5mL N 20181231 70920-040_ab1d1302-605a-4106-9a39-bc373d751261 70920-040 HUMAN OTC DRUG Jayjun Real Water Brightening Black Mask Step1 Real Water Cleansing Foa m Glycerin LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. GLYCERIN .2 g/1.5mL N 20181231 70920-050_8ca84c94-08d7-464a-b327-36243e9f95d4 70920-050 HUMAN OTC DRUG Jayjun Real Water Brightening Black Mask Step2 Jayjun Vita Snow Essence Glycerin, Niacinamide, Allantoin, Adenosine LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. GLYCERIN; NIACINAMIDE; ALLANTOIN; ADENOSINE .06; .03; .001; .0006 g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL N 20181231 70920-060_5ba7e19c-bc11-4f32-ade1-b1b3d2d078a1 70920-060 HUMAN OTC DRUG Jayjun Real Water Brightening Black Mask Step3 Real Water Brightening Black Mask Glycerin, Niacinamide, Allantoin, Adenosine PATCH TOPICAL 20160801 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. GLYCERIN; NIACINAMIDE; ALLANTOIN; ADENOSINE .76; .5; .02; .01 g/25mL; g/25mL; g/25mL; g/25mL N 20181231 70920-070_f4db472d-3b82-41e4-b3c7-ceb796b5a83b 70920-070 HUMAN OTC DRUG JAYJUN BIOCELLULOSE MASK Glycerin PATCH TOPICAL 20170901 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. GLYCERIN 1.61 g/30mL N 20181231 70920-080_71b59423-bae6-48d3-a0c6-4467410cc875 70920-080 HUMAN OTC DRUG JAYJUN COLLAGEN SKIN FIT MASK STEP 01 HYALURONIC ACID ESSENCE Niacinamide, Adenosine LIQUID TOPICAL 20170901 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE .03; .0006 g/1.5mL; g/1.5mL N 20181231 70920-090_86b479f9-2bef-4aef-93f6-c186556085a2 70920-090 HUMAN OTC DRUG JAYJUN COLLAGEN SKIN FIT MASK STEP 02 PLANT STEM CELL MASK Niacinamide, Adenosine PATCH TOPICAL 20170901 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. NIACINAMIDE; ADENOSINE .5; .01 g/25mL; g/25mL N 20181231 70920-100_9ec0b45b-c5fb-4b6a-9aa8-2cdf3c26a930 70920-100 HUMAN OTC DRUG JAYJUN ROSE BLOSSOM MASK Glycerin PATCH TOPICAL 20170901 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. GLYCERIN 1 g/25mL N 20181231 70920-110_a7c3c9a2-ee01-4e37-9219-eb54ad103c55 70920-110 HUMAN OTC DRUG JAYJUN ALL IN ONE MULTI CLEANSING MASK Step 01 COTTON SW AB LIP AND EYE REMOVER Glycerin SWAB TOPICAL 20171101 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. GLYCERIN .25 g/2.5mL N 20181231 70920-120_4eafd699-2ed4-4a07-bf0f-c8ac1a1c2f45 70920-120 HUMAN OTC DRUG JAYJUN ALL IN ONE MULTI CLEANSING MASK Step 02 BUBBLE CLEANSING MASK Glycerin PATCH TOPICAL 20171101 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. GLYCERIN 2.5 g/25mL N 20181231 70920-130_2cdcac80-fe3e-45f7-a484-114ca4217ee9 70920-130 HUMAN OTC DRUG JAYJUN ANTI DUST BRIGHTENING MASK 01 JAYJUN ANTI DUST LUMINOUS MASK Niacinamide PATCH TOPICAL 20171101 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. NIACINAMIDE .54 g/27mL N 20181231 70920-140_b90e286d-6bb3-44a9-935f-61fa301febc6 70920-140 HUMAN OTC DRUG JAYJUN ANTI DUST BRIGHTENING MASK 02 JAYJUN ANTI DUST LUSTER AMPLE Niacinamide LIQUID TOPICAL 20171101 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. NIACINAMIDE .03 g/1.5mL N 20181231 70920-150_a851f418-29cc-4ba7-b2ed-985c684caf37 70920-150 HUMAN OTC DRUG JAYJUN ANTI DUST BRIGHTENING MASK 03 JAYJUN ANTI DUST EYES UNDER CORRECTOR Dimethicone LIQUID TOPICAL 20171101 OTC MONOGRAPH FINAL part347 JAYJUN COSMETIC Co.,Ltd. DIMETHICONE .06 g/1.5mL N 20181231 70920-160_22a43baf-6981-4bfe-864f-0db4a0e11244 70920-160 HUMAN OTC DRUG JAYJUN ANTI DUST THERAPY MASK STEP 01 JAYJUN ANTI DUST FRESH FO AM CLEANSER Glycerin LIQUID TOPICAL 20171101 OTC MONOGRAPH FINAL part347 JAYJUN COSMETIC Co.,Ltd. GLYCERIN .3 g/1.5mL N 20181231 70920-170_0d8c8f86-bfbc-42f3-99b2-4e2832317d01 70920-170 HUMAN OTC DRUG JAYJUN ANTI DUST THERAPY MASK STEP 02 JAYJUN ANTI DUST THERAPY MASK Glycerin PATCH TOPICAL 20171101 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. GLYCERIN 1.08 g/27mL N 20181231 70920-180_026f4c21-7ee8-46f3-b5c7-217d6a741efe 70920-180 HUMAN OTC DRUG JAYJUN ANTI DUST THERAPY MASK STEP 03 JAYJUN ANTI DUST INTENSIVE Dimethicone CREAM TOPICAL 20171101 OTC MONOGRAPH FINAL part347 JAYJUN COSMETIC Co.,Ltd. DIMETHICONE .04 g/1.5mL N 20181231 70920-190_db7560f6-79d5-4f89-967c-a0869c2e380f 70920-190 HUMAN OTC DRUG JAYJUN BLACK PEARL FIRST REPAIR SERUM Dimethicone CREAM TOPICAL 20171101 OTC MONOGRAPH FINAL part347 JAYJUN COSMETIC Co.,Ltd. DIMETHICONE .75 g/50mL N 20181231 70920-200_bdb5ec1b-9a74-42fa-bc25-a7cd87f38739 70920-200 HUMAN OTC DRUG JAYJUN GOLD SNOW BLACK MASK Niacinamide PATCH TOPICAL 20171101 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. NIACINAMIDE .5 g/25mL N 20181231 70920-210_db6b8957-db7d-40a5-915f-a550693a14ad 70920-210 HUMAN OTC DRUG JAYJUN MULTI VITA TONE UP MASK Niacinamide PATCH TOPICAL 20171101 UNAPPROVED DRUG OTHER JAYJUN COSMETIC Co.,Ltd. NIACINAMIDE .002 g/25mL N 20181231 70924-001_c1c0481b-1d9f-47e3-b89a-253267ad0d77 70924-001 HUMAN OTC DRUG Touchpoint Wipes Sanitizing Wipes Benzalkonium Chloride CLOTH CUTANEOUS 20160909 OTC MONOGRAPH NOT FINAL part333E Innocore Sales & Marketing Inc BENZALKONIUM CHLORIDE 1.3 mg/1 N 20181231 70924-002_a0c9c120-7a43-4507-844f-931af123c3d3 70924-002 HUMAN OTC DRUG Touchpoint Wipes Fragrance Free Sanitizing Wipes Benzalkonium Chloride CLOTH CUTANEOUS 20160909 OTC MONOGRAPH NOT FINAL part333E Innocore Sales & Marketing Inc BENZALKONIUM CHLORIDE 1.3 mg/1 N 20181231 70925-001_4179faf7-880b-409c-8822-6b1e2076355e 70925-001 HUMAN OTC DRUG Humana Pharmacy All Day Allergy Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20161221 ANDA ANDA078336 Humana Pharmacy, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 70925-029_900263e1-dea9-410e-8cbf-e79f84faad9d 70925-029 HUMAN OTC DRUG Humana Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20161221 ANDA ANDA076775 Humana Pharmacy, Inc. NICOTINE 2 mg/1 N 20181231 70925-094_096a07fe-4b64-49a8-8e8b-8116f15567ce 70925-094 HUMAN OTC DRUG Humana Pharmacy Nasal Decongestant PE Phenylephrine Hydrochloride TABLET, FILM COATED ORAL 20161221 OTC MONOGRAPH FINAL part341 Humana Pharmacy, Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 N 20181231 70925-170_38b2833f-ac43-4e8d-9104-fd22089c407e 70925-170 HUMAN OTC DRUG Humana Pharmacy Nicotine Nicotine Polacrilex GUM, CHEWING ORAL 20161221 ANDA ANDA076789 Humana Pharmacy, Inc. NICOTINE 4 mg/1 N 20181231 70925-188_5960d311-3e89-49a3-bac0-ebfcda575653 70925-188 HUMAN OTC DRUG Humana Pharmacy Hemorrhoidal mineral oil, petrolatum, phenylephrine HCl OINTMENT RECTAL 20170124 OTC MONOGRAPH FINAL part346 Humana Pharmacy, Inc. MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE 14; 74.9; .25 g/100g; g/100g; g/100g N 20181231 70925-194_6e9cb258-cf43-42d8-b5c4-4282c73f9b9c 70925-194 HUMAN OTC DRUG Humana Pharmacy Acid Reducer Famotidine TABLET ORAL 20161221 ANDA ANDA077351 Humana Pharmacy, Inc. FAMOTIDINE 20 mg/1 N 20181231 70925-272_22ac974b-2480-4691-9101-917d1371c87c 70925-272 HUMAN OTC DRUG Humana Pharmacy Sinus Relief Acetaminophen, Phenylephrine HCl TABLET, FILM COATED ORAL 20161221 OTC MONOGRAPH FINAL part341 Humana Pharmacy, Inc. ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE 325; 5 mg/1; mg/1 N 20181231 70925-306_6ac9fd2b-8365-49a5-bb7b-f5c989e54d26 70925-306 HUMAN OTC DRUG Humana Pharmacy Clear Laxative Polyethylene Glycol 3350 POWDER, FOR SOLUTION ORAL 20161221 ANDA ANDA090685 Humana Pharmacy, Inc. POLYETHYLENE GLYCOL 3350 17 g/17g N 20191231 70925-368_5e5049d3-1788-47a1-b419-95d429759f2a 70925-368 HUMAN OTC DRUG Humana Pharmacy All Day Pain Relief Naproxen Sodium TABLET, FILM COATED ORAL 20161221 ANDA ANDA074661 Humana Pharmacy, Inc. NAPROXEN SODIUM 220 mg/1 N 20181231 70925-516_0ecf3a56-388e-48be-8eef-d7e580ec4a11 70925-516 HUMAN OTC DRUG Humana Pharmacy Tussin Multi Symptom Cold Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride SOLUTION ORAL 20161221 OTC MONOGRAPH FINAL part341 Humana Pharmacy, Inc. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 200; 10 mg/10mL; mg/10mL; mg/10mL N 20181231 70925-604_26b44c32-5a29-42df-bdc3-8b3ac64a97ac 70925-604 HUMAN OTC DRUG Humana Pharmacy Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20161221 ANDA ANDA072096 Humana Pharmacy, Inc. IBUPROFEN 200 mg/1 N 20181231 70925-612_ab89dce1-2eb6-4cf4-bbf9-c982ac5e6e4f 70925-612 HUMAN OTC DRUG Humana Pharmacy Allergy Relief Loratadine TABLET ORAL 20161221 ANDA ANDA076301 Humana Pharmacy, Inc. LORATADINE 10 mg/1 N 20181231 70925-897_067e7a81-9e80-438d-b15d-ad624533c46e 70925-897 HUMAN OTC DRUG Humana Pharmacy Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20161221 ANDA ANDA074937 Humana Pharmacy, Inc. IBUPROFEN 100 mg/5mL N 20181231 70925-915_e1da8e04-147c-4b9e-9be4-c799e2906d96 70925-915 HUMAN OTC DRUG Humana Pharmacy Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20161221 NDA NDA022032 Humana Pharmacy, Inc. OMEPRAZOLE 20 mg/1 N 20181231 70925-994_88c3cbd8-4630-41c2-8be2-acb09a0e76b6 70925-994 HUMAN OTC DRUG Humana Pharmacy Daytime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl CAPSULE, LIQUID FILLED ORAL 20161221 OTC MONOGRAPH FINAL part341 Humana Pharmacy, Inc. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 70927-001_61841d96-301f-0a7a-e053-2991aa0a5986 70927-001 HUMAN OTC DRUG EXTERNAL ANALGESIC camphor, capsicum, menthol PATCH TOPICAL 20160825 OTC MONOGRAPH NOT FINAL part348 Hmong 21 CAMPHOR (SYNTHETIC); CAPSAICIN; MENTHOL 96; .5; 78 mg/g; mg/g; mg/g N 20181231 70929-0001_3ab2baf1-237e-3c98-e054-00144ff8d46c 70929-0001 HUMAN OTC DRUG Antibe Super Hydrating Moisturizing Cream Adenosine CREAM TOPICAL 20150701 UNAPPROVED DRUG OTHER Modongee Co., Ltd. ADENOSINE .04 g/100mL E 20171231 70929-0002_3ab4793c-6c92-2957-e054-00144ff8d46c 70929-0002 HUMAN OTC DRUG Antibe Beausenne Special Ampoule Niacinamide, Adenosine GEL TOPICAL 20150701 UNAPPROVED DRUG OTHER Modongee Co., Ltd. ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL E 20171231 70930-010_1280342d-d6ec-45df-80ae-900b76c8595c 70930-010 HUMAN OTC DRUG Cell Acher Sports Body Massage VANILLYL BUTYL ETHER CREAM TOPICAL 20160801 UNAPPROVED DRUG OTHER Natuzen Co., Ltd VANILLYL BUTYL ETHER 1.53 g/153g N 20181231 70930-020_965298da-87b4-4c10-a555-4efc7606a3f2 70930-020 HUMAN OTC DRUG 88 Tong Tong varcia Sports Body Massage VANILLYL BUTYL ETHER CREAM TOPICAL 20160801 UNAPPROVED DRUG OTHER Natuzen Co., Ltd VANILLYL BUTYL ETHER 1.53 g/153g N 20181231 70931-0001_3bbcb812-fee8-3b00-e054-00144ff88e88 70931-0001 HUMAN OTC DRUG D-ONE BY TAMDOAN SUNSCREEN 50 Titanium dioxide, Zinc Oxide, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Adenosine, Arbutin CREAM TOPICAL 20160223 UNAPPROVED DRUG OTHER DRAN CO.,LTD TITANIUM DIOXIDE; ZINC OXIDE; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; ADENOSINE; ARBUTIN 2.54; 5.99; 2; 1; 7; 5; .04; 2 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70931-0003_3bbcb812-ff00-3b00-e054-00144ff88e88 70931-0003 HUMAN OTC DRUG D-ONE BY TAMDOAN BB MEDIUM Titanium dioxide, Zinc Oxide, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Adenosine, Arbutin CREAM TOPICAL 20160223 UNAPPROVED DRUG OTHER DRAN CO.,LTD TITANIUM DIOXIDE; ZINC OXIDE; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; ADENOSINE; ARBUTIN 2.54; 5.99; 2; 1; 7; 5; .04; 2 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70931-0005_5f1b0b79-6a67-47ae-e053-2991aa0a02ba 70931-0005 HUMAN OTC DRUG Wonder Intensive BBCream 21 (Light) Titanium dioxide, Zinc Oxide, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Adenosine, Arbutin CREAM TOPICAL 20160223 UNAPPROVED DRUG OTHER DRAN CO.,LTD TITANIUM DIOXIDE; ZINC OXIDE; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; ADENOSINE; ARBUTIN 2.54; 5.99; 2; 1; 7; 5; .04; 2 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 70933-010_a24a467b-4755-4e07-8225-f1d4e020d694 70933-010 HUMAN OTC DRUG Vitabrid C12 Hair Allantoin POWDER TOPICAL 20160901 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. ALLANTOIN .2 mg/2g N 20181231 70933-020_6b9352aa-30a7-4508-91a2-ac0be304db7b 70933-020 HUMAN OTC DRUG Vitabrid C12 Hair Tonic Salicylic acid LIQUID TOPICAL 20160901 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. SALICYLIC ACID .25 g/100mL N 20181231 70933-030_4ce49890-15ca-4073-8ff7-47a764e99bec 70933-030 HUMAN OTC DRUG Vitabrid C12 FACE BRIGHTENING Niacinamide, Adenosine, Allantoin POWDER TOPICAL 20160901 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. NIACINAMIDE; ADENOSINE; ALLANTOIN .15; .12; .007 g/3g; g/3g; g/3g N 20181231 70933-040_1d90ecb9-181e-4d27-97f8-f1f1195f0df8 70933-040 HUMAN OTC DRUG Vitabrid C12 SENSITIVE Spot Pow der Serum Niacinamide, Adenosine POWDER TOPICAL 20161010 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. NIACINAMIDE; ADENOSINE .1; .002 g/5g; g/5g N 20181231 70933-050_567c95b4-4c12-438f-95fb-410ed60052ae 70933-050 HUMAN OTC DRUG Thanks 12 Rich Caviar Mask Glycerin, Niacinamide, Allantoin, Adenosine PATCH TOPICAL 20161010 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. GLYCERIN; NIACINAMIDE; ALLANTOIN; ADENOSINE 1.27; .5; .07; .01 g/25mL; g/25mL; g/25mL; g/25mL N 20181231 70933-060_7b9d4451-874f-4ad1-8ab5-0c7f4ef125d5 70933-060 HUMAN OTC DRUG Thanks 12 Rich Caviar Mist Niacinamide, Allantoin, Adenosine SPRAY TOPICAL 20161010 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. NIACINAMIDE; ALLANTOIN; ADENOSINE .25; .05; .005 g/50mL; g/50mL; g/50mL N 20181231 70933-070_df1737b1-b5a0-4b1e-958c-3af9fe78698f 70933-070 HUMAN OTC DRUG Thanks 12 Rich Caviar Fo am Cleanser Glycerin INJECTABLE FOAM TOPICAL 20161010 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. GLYCERIN 16.5 g/150mL N 20181231 70933-080_93799b6c-e966-4fcc-b8a8-ed62772597db 70933-080 HUMAN OTC DRUG Thanks 12 Aqua Water Toner Glycerin LIQUID TOPICAL 20161010 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. GLYCERIN 6 g/200mL N 20181231 70933-090_f4aff860-7376-4230-8099-204d66c79c41 70933-090 HUMAN OTC DRUG Vitabrid C12 Face Sensitive Allantoin POWDER TOPICAL 20161101 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. ALLANTOIN .003 g/3g N 20181231 70933-100_aaacd35e-ecce-449e-aa3d-1174aee6ddec 70933-100 HUMAN OTC DRUG Vitabrid C12 Face Sensitive Anti Blemish Essence Witch Hazel CREAM TOPICAL 20161101 OTC MONOGRAPH FINAL part347 HYUNDAI IBT CO., LTD. WITCH HAZEL .25 g/50mL N 20181231 70933-110_15d122a3-5e68-4650-bfc1-d68dc17d78e9 70933-110 HUMAN OTC DRUG Vitabrid SCALP CARE Propylene Glycol SHAMPOO TOPICAL 20161101 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. PROPYLENE GLYCOL 10 g/500mL N 20181231 70933-120_34f03ff2-6a52-47d4-ac8f-615412d9cb11 70933-120 HUMAN OTC DRUG Vitabrid C12 ATOSIS Allantoin POWDER TOPICAL 20161101 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. ALLANTOIN .3 mg/3g N 20181231 70933-130_83c83e06-c2bb-4ec0-a594-882bf6d95756 70933-130 HUMAN OTC DRUG Vitabrid C12 ATOSIS Glycerin, Allantoin CREAM TOPICAL 20161101 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. GLYCERIN; ALLANTOIN .1; .01 g/100mL; g/100mL N 20181231 70933-140_3d1f0ba6-f25d-427e-83c9-bc3efe420d9b 70933-140 HUMAN OTC DRUG ATOSIS Mist Glycerin SPRAY TOPICAL 20161101 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. GLYCERIN .075 g/75mL N 20181231 70933-150_e0e569fb-8d25-4692-9033-f7a15dc6fc87 70933-150 HUMAN OTC DRUG Vitabrid C12 FACE 3g Zinc Oxide POWDER TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 HYUNDAI IBT CO., LTD. ZINC OXIDE .69 g/3g N 20181231 70933-160_e1711ace-afe6-4748-b7cf-26aeffcc428e 70933-160 HUMAN OTC DRUG Vitabrid C12 FACE 4g Allantoin, Adenosine, Niacinamide POWDER TOPICAL 20161201 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. ALLANTOIN; ADENOSINE; NIACINAMIDE .2; .04; .04 g/4g; g/4g; g/4g N 20181231 70933-170_18fd5d97-c9cb-49a3-b7cc-8773264b1020 70933-170 HUMAN OTC DRUG Vitabrid C12 FACE Pow der 2g Allantoin, Niacinamide, Adenosine POWDER TOPICAL 20161201 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. ALLANTOIN; NIACINAMIDE; ADENOSINE .2; .1; .02 g/2g; g/2g; g/2g N 20181231 70933-180_6372f4f7-e173-4c7c-b40c-d6eec73d02aa 70933-180 HUMAN OTC DRUG Vitabrid C12 FACE Pow der 3g Allantoin, Arbutin, Adenosine POWDER TOPICAL 20161201 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. ALLANTOIN; ARBUTIN; ADENOSINE .6; .27; .06 g/3g; g/3g; g/3g N 20181231 70933-190_7463fd17-baaf-44a1-803a-a07ce5a06113 70933-190 HUMAN OTC DRUG Vitabrid C12 FACE 12H VITAMIN C Zinc Oxide POWDER TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 HYUNDAI IBT CO., LTD. ZINC OXIDE .69 g/3g N 20181231 70933-200_1aba651a-bf71-42b0-bfe1-4fa2d67ca52e 70933-200 HUMAN OTC DRUG Vitabrid C12 HAIR POW DER PROFESSIONAL Allantoin POWDER TOPICAL 20161201 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. ALLANTOIN .2 mg/2g N 20181231 70933-210_867308e2-8699-4dea-b2da-8d2cb0db54f1 70933-210 HUMAN OTC DRUG Vitabrid C12 HAIR TONIC PROFESSIONAL Salicylic acid LIQUID TOPICAL 20161201 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. SALICYLIC ACID .15 g/100mL N 20181231 70933-300_52aad275-ca71-2137-e054-00144ff88e88 70933-300 HUMAN OTC DRUG Vitabrid C12 DOCTOR Sensitive Face Powder zinc oxide POWDER TOPICAL 20170624 OTC MONOGRAPH FINAL part347 HYUNDAI IBT CO., LTD. ZINC OXIDE; ALLANTOIN 25; .3 g/100g; g/100g N 20181231 70933-301_53d571a8-eff5-1335-e054-00144ff8d46c 70933-301 HUMAN OTC DRUG Vitabrid C12 Face Brightening zinc oxide POWDER TOPICAL 20170709 OTC MONOGRAPH FINAL part347 HYUNDAI IBT CO., LTD. ZINC OXIDE; ALLANTOIN 25; .25 g/100g; g/100g N 20181231 70933-302_53d89f4c-2fa5-3513-e054-00144ff88e88 70933-302 HUMAN OTC DRUG Vitabrid Scalp menthol SHAMPOO TOPICAL 20170709 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. MENTHOL; PANTHENOL .3; .2 g/100mL; g/100mL N 20181231 70933-303_53d93d08-1fe5-6958-e054-00144ff8d46c 70933-303 HUMAN OTC DRUG Vitabrid C12 Hair Powder Scalp Relief zinc oxide POWDER TOPICAL 20170709 OTC MONOGRAPH FINAL part347 HYUNDAI IBT CO., LTD. ZINC OXIDE; ALLANTOIN 27.81; .01 g/100g; g/100g N 20181231 70933-304_545119e6-34ee-25c4-e054-00144ff88e88 70933-304 HUMAN OTC DRUG Vitabrid C12 Hair Tonic Scalp Relief menthol LIQUID TOPICAL 20170715 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. MENTHOL; PANTHENOL .3; .2 g/100mL; g/100mL N 20181231 70933-305_54034006-4581-5ba5-e054-00144ff88e88 70933-305 HUMAN OTC DRUG Vitabrid C12 Hair Powder Professional zinc oxide POWDER TOPICAL 20170709 OTC MONOGRAPH FINAL part347 HYUNDAI IBT CO., LTD. ZINC OXIDE; ALLANTOIN 24.6; .01 g/100g; g/100g N 20181231 70933-306_53da581a-cc82-6d1e-e054-00144ff88e88 70933-306 HUMAN OTC DRUG Vitabrid C12 Hair Tonic Professional menthol LIQUID TOPICAL 20170709 UNAPPROVED DRUG OTHER HYUNDAI IBT CO., LTD. PANTHENOL; MENTHOL .2; .3 g/100mL; g/100mL N 20181231 70933-311_55421010-d80b-4ca4-e054-00144ff88e88 70933-311 HUMAN OTC DRUG Vitabrid C12 Spot Acne Ampoule salicylic acid LIQUID TOPICAL 20170715 OTC MONOGRAPH FINAL part333D HYUNDAI IBT CO., LTD. SALICYLIC ACID .5 g/100mL N 20181231 70934-014_648e9841-3f88-0f04-e053-2a91aa0a1326 70934-014 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20180103 ANDA ANDA091672 Denton Pharma, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 70934-026_4af70eae-7179-65f2-e054-00144ff88e88 70934-026 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20170316 ANDA ANDA204197 Denton Pharma, Inc. CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70934-027_4b309d36-21af-35ce-e054-00144ff8d46c 70934-027 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170317 ANDA ANDA076201 Denton Pharma, Inc. DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70934-029_4af70eae-71cb-65f2-e054-00144ff88e88 70934-029 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 20170317 ANDA ANDA074754 Denton Pharma, Inc. KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 70934-030_4cfae413-87db-091b-e054-00144ff88e88 70934-030 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20170327 ANDA ANDA077918 Denton Pharma, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70934-031_4aa335d1-1f23-72c8-e054-00144ff8d46c 70934-031 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE, EXTENDED RELEASE ORAL 20170313 ANDA ANDA201807 Denton Pharma, Inc. INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70934-032_4cfa6682-6a1b-6f42-e054-00144ff88e88 70934-032 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170404 ANDA ANDA091625 Denton Pharma, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 70934-033_5dde41dd-b6d9-c94a-e053-2991aa0a129b 70934-033 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20170629 ANDA ANDA065271 Denton Pharma, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 70934-034_5dde291e-05c8-841e-e053-2991aa0a8eec 70934-034 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20170727 ANDA ANDA065248 Denton Pharma, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 70934-035_5ddedd5b-2130-5a18-e053-2a91aa0affbe 70934-035 HUMAN PRESCRIPTION DRUG Penicillin V Potassium Penicillin V Potassium TABLET, FILM COATED ORAL 20170629 ANDA ANDA065435 Denton Pharma, Inc. PENICILLIN V POTASSIUM 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 70934-037_5ddf32f9-9a93-4a31-e053-2a91aa0a8e61 70934-037 HUMAN PRESCRIPTION DRUG cephalexin cephalexin CAPSULE ORAL 20171031 ANDA ANDA065248 Denton Pharma, Inc. CEPHALEXIN 250 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 70934-038_643c5333-8ee2-75db-e053-2991aa0ab2b8 70934-038 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20171023 ANDA ANDA065256 Denton Pharma, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 70934-039_61cfb334-ebae-6290-e053-2a91aa0aea0d 70934-039 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20171023 ANDA ANDA091568 Denton Pharma, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 875; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 70934-040_5d8113e5-50c4-c4ce-e053-2a91aa0ac026 70934-040 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20171030 ANDA ANDA090836 Denton Pharma, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 70934-041_5fb10c65-169e-6a22-e053-2a91aa0a70d2 70934-041 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20171030 ANDA ANDA065062 Denton Pharma, Inc. MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 70934-042_5fb10c65-169e-6a22-e053-2a91aa0a70d2 70934-042 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20171030 ANDA ANDA065062 Denton Pharma, Inc. MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 70934-043_5f0c1ea9-3175-3643-e053-2a91aa0a2d5c 70934-043 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20171030 ANDA ANDA071017 Denton Pharma, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 70934-044_5f0cc4ae-0e7a-4946-e053-2a91aa0a29e1 70934-044 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20171114 ANDA ANDA065434 Denton Pharma, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 70934-045_5fd60635-4b69-15e3-e053-2991aa0ab23a 70934-045 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20171121 ANDA ANDA076639 Denton Pharma, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 70934-046_643c7ad0-b78d-d825-e053-2991aa0acb59 70934-046 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 20171121 ANDA ANDA062500 Denton Pharma, Inc. DOXYCYCLINE HYCLATE 100 mg/1 N 20191231 70934-047_5fd5e21b-98fc-e886-e053-2991aa0a5124 70934-047 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20171121 NDA NDA020064 Denton Pharma, Inc. NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 70934-048_5fd5aac8-d223-9960-e053-2991aa0abeea 70934-048 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20171124 ANDA ANDA065061 Denton Pharma, Inc. CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 70934-049_61cf1613-ba12-5fc1-e053-2991aa0aaa74 70934-049 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20171205 ANDA ANDA090624 Denton Pharma, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20191231 70934-050_61d0830f-05fc-542b-e053-2991aa0a0aff 70934-050 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20171205 ANDA ANDA202801 Denton Pharma, Inc. LEVOFLOXACIN 500 mg/1 N 20191231 70934-052_615509f5-44fb-2a6e-e053-2991aa0a8f27 70934-052 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20171218 ANDA ANDA065061 Denton Pharma, Inc. CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20181231 70934-053_64415982-987c-4515-e053-2a91aa0a907d 70934-053 HUMAN PRESCRIPTION DRUG Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20171220 ANDA ANDA091569 Denton Pharma, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 70934-054_643c7ad0-b7fe-d825-e053-2991aa0acb59 70934-054 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20171220 ANDA ANDA064076 Denton Pharma, Inc. AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 70934-055_643ca3b8-8f9a-27ca-e053-2a91aa0a4666 70934-055 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20171227 ANDA ANDA202765 Denton Pharma, Inc. BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 70934-056_643cf901-5f51-6af1-e053-2991aa0a876b 70934-056 HUMAN PRESCRIPTION DRUG Cefadroxil Cefadroxil CAPSULE ORAL 20171228 ANDA ANDA065352 Denton Pharma, Inc. CEFADROXIL 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 70934-057_643d3a2d-374e-b0c1-e053-2991aa0aae0b 70934-057 HUMAN PRESCRIPTION DRUG AMOXICILLIN AND CLAVULANATE POTASSIUM Amoxicillin and Clavulanate Potassium TABLET, FILM COATED ORAL 20171229 ANDA ANDA205707 Denton Pharma, Inc. AMOXICILLIN; CLAVULANATE POTASSIUM 500; 125 mg/1; mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA] N 20191231 70934-058_643d8398-6856-0f90-e053-2a91aa0af1ee 70934-058 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20180102 ANDA ANDA040597 Denton Pharma, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20191231 70934-059_643d9208-f087-15da-e053-2a91aa0ac100 70934-059 HUMAN PRESCRIPTION DRUG Ampicillin Ampicillin CAPSULE ORAL 20180102 ANDA ANDA064082 Denton Pharma, Inc. AMPICILLIN TRIHYDRATE 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 70934-060_643e5275-9697-3745-e053-2991aa0aacea 70934-060 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20180104 ANDA ANDA090939 Denton Pharma, Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 70934-061_643de9a3-e28b-3521-e053-2991aa0a7140 70934-061 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20180104 ANDA ANDA076164 Denton Pharma, Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 70934-062_643e29d8-d671-3923-e053-2a91aa0a3eb9 70934-062 HUMAN PRESCRIPTION DRUG Cefdinir Cefdinir CAPSULE ORAL 20180108 ANDA ANDA065434 Denton Pharma, Inc. CEFDINIR 300 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 70934-063_643c7ad0-b7fd-d825-e053-2991aa0acb59 70934-063 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20180115 ANDA ANDA077797 Denton Pharma, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 70934-064_644006ba-3adc-554b-e053-2991aa0a1ce2 70934-064 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin TABLET, FILM COATED ORAL 20180115 ANDA ANDA065256 Denton Pharma, Inc. AMOXICILLIN 875 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20191231 70934-065_6440351e-0660-59da-e053-2a91aa0aa4c5 70934-065 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20180118 ANDA ANDA065229 Denton Pharma, Inc. CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20191231 70934-066_6440960f-9b8e-021c-e053-2a91aa0a3eed 70934-066 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20180123 ANDA ANDA077095 Denton Pharma, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 70934-067_6440befe-43ef-4a66-e053-2a91aa0a117a 70934-067 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20180125 ANDA ANDA077073 Denton Pharma, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 70934-068_6440a079-a145-4ca9-e053-2991aa0a3421 70934-068 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20180124 ANDA ANDA076639 Denton Pharma, Inc. CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 70934-069_6440edee-7122-78f2-e053-2991aa0a604e 70934-069 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20180125 ANDA ANDA091624 Denton Pharma, Inc. ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 70934-070_6440edee-7122-78f2-e053-2991aa0a604e 70934-070 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20180125 ANDA ANDA091624 Denton Pharma, Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 70934-071_647d1ec0-1b5b-3f09-e053-2a91aa0a9ccb 70934-071 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20180125 ANDA ANDA202446 Denton Pharma, Inc. AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 70936-105_5b1ef4d0-9480-4e11-bb58-e4063450e554 70936-105 HUMAN OTC DRUG AVANCE CURE INCONTINENCE ALLANTOIN, DIMETHICONE CREAM TOPICAL 20160823 OTC MONOGRAPH FINAL part347 SMART CHOICE MEDICAL INC. ALLANTOIN; DIMETHICONE 1.5; 2 g/100g; g/100g N 20181231 70936-106_611d48e0-3ce7-484c-93eb-ebd61c343102 70936-106 HUMAN OTC DRUG AVANCE CURE BARRIER ALLANTOIN, DIMETHICONE, MENTHOL CREAM TOPICAL 20160822 OTC MONOGRAPH FINAL part347 SMART CHOICE MEDICAL INC. ALLANTOIN; DIMETHICONE; MENTHOL .5; 2; .45 g/100g; g/100g; g/100g N 20181231 70936-107_e82923c9-386e-470f-bf72-ff004d9e8fb1 70936-107 HUMAN OTC DRUG AVANCE CURE ANTI-BACTERIAL PERINEAL BENZALKONIUM CHLORIDE SPRAY TOPICAL 20160822 OTC MONOGRAPH NOT FINAL part333E SMART CHOICE MEDICAL INC. BENZALKONIUM CHLORIDE .3 g/100mL N 20181231 70937-100_f72eb056-4721-45be-88d1-0de1594382be 70937-100 HUMAN OTC DRUG EH Hair Plus Regeneration Hair Care Panthenol, Niacinamide, Menthol, Salicylic Acid KIT 20160825 UNAPPROVED DRUG OTHER ECOBIO Medical Institute, Inc. E 20171231 70937-104_c0290d66-fb24-4027-9bd9-481b07a761e6 70937-104 HUMAN OTC DRUG EH Plus H2CO3 Cool Panthenol, Menthol KIT 20161017 UNAPPROVED DRUG OTHER ECOBIO Medical Institute, Inc. E 20171231 70938-001_49ab0958-1921-299f-e054-00144ff88e88 70938-001 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120724 ANDA ANDA040788 1 Veterans Health HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 70938-003_49ac3053-8784-6c69-e054-00144ff8d46c 70938-003 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 1 Veterans Health CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 70939-001_63c17712-8ee0-2235-e053-2991aa0a9a18 70939-001 HUMAN OTC DRUG Hand sanitizer Alcohol SWAB TOPICAL 20160831 OTC MONOGRAPH NOT FINAL part333E Dongguang Shuoguo Silicone Products Co., Ltd. ALCOHOL 63 mL/100mL N 20191231 70939-002_4ac3bdcd-f52e-08c0-e054-00144ff8d46c 70939-002 HUMAN OTC DRUG Hand sanitizer Alcohol SWAB TOPICAL 20160831 OTC MONOGRAPH NOT FINAL part333E Dongguang Shuoguo Silicone Products Co., Ltd. ALCOHOL 65 mL/100mL N 20181231 70942-010_3a822820-a10a-445d-8469-93de034c8333 70942-010 HUMAN OTC DRUG Hemorrhoid and Fissure Dr. Butler Lidocaine 4.00 Phenylephrine Hydrochloride 0.25 OINTMENT TOPICAL 20070828 OTC MONOGRAPH FINAL part346 Beyond Health P.A. LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE 4; .25 g/100g; g/100g N 20181231 70945-100_0bb9ed06-551f-4d53-9100-4a9755cac059 70945-100 HUMAN OTC DRUG Tolcylen Antifungal Solution Tolnaftate SOLUTION TOPICAL 20161216 OTC MONOGRAPH FINAL part333C Marlinz Pharma, LLC TOLNAFTATE 1 mg/100mL N 20181231 70945-200_f9ee4b99-50d1-41a5-9a98-7981c45325e3 70945-200 HUMAN OTC DRUG Tolcylen Antifungal Cream Tolnaftate CREAM TOPICAL 20161216 OTC MONOGRAPH FINAL part333C Marlinz Pharma, LLC TOLNAFTATE .2 mg/20mg N 20181231 70946-010_b4138288-fdb2-4430-b582-64e800a2179e 70946-010 HUMAN OTC DRUG Sanoba Lidocaine SPRAY TOPICAL 20160715 OTC MONOGRAPH NOT FINAL part348 Myungmoon Pharm. Co.,Ltd LIDOCAINE 1.1 g/12g N 20181231 70949-100_7bd7d6e0-0be8-480a-9c2f-d69852141e1c 70949-100 HUMAN OTC DRUG Bellido Hydro Secret Ampoule Dimethicone, Panthenol LIQUID TOPICAL 20160906 OTC MONOGRAPH FINAL part347 C MAX Korea Co., Ltd DIMETHICONE 2.5 g/50mL E 20171231 70951-123_60c70d70-a9f8-7644-e053-2a91aa0a7cf6 70951-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20160830 UNAPPROVED MEDICAL GAS Laurel Medical Supplies, Inc. dba Laurel Medical Solutions OXYGEN 99 L/100L N 20181231 70953-001_3bdbb536-aec0-0b9c-e054-00144ff88e88 70953-001 HUMAN OTC DRUG BioArmor Alcohol Free Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20160906 OTC MONOGRAPH NOT FINAL part333E BioArmor, LLC BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 70954-005_3b1f5585-9b33-4a96-bf33-8e6bab14bf0c 70954-005 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 20171115 ANDA ANDA209823 Novitium Pharma LLC OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 70954-135_57a47368-d1f6-4d61-a2ee-c5f1fe7ff690 70954-135 HUMAN PRESCRIPTION DRUG DAPSONE Dapsone TABLET ORAL 20180115 ANDA ANDA206505 Novitium Pharma LLC DAPSONE 25 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 70954-136_57a47368-d1f6-4d61-a2ee-c5f1fe7ff690 70954-136 HUMAN PRESCRIPTION DRUG DAPSONE Dapsone TABLET ORAL 20180115 ANDA ANDA206505 Novitium Pharma LLC DAPSONE 100 mg/1 Sulfone [EPC],Sulfones [Chemical/Ingredient] N 20181231 70955-886_81632fa7-96bd-4df4-a056-c82303a5cdcf 70955-886 HUMAN OTC DRUG Dynamiclear ORO CAMPHOR (NATURAL) SWAB TOPICAL 20160905 OTC MONOGRAPH NOT FINAL part348 Dynamiclear Partners LLC CAMPHOR (NATURAL) .15 mg/g E 20171231 70957-0016_3c6575e1-36df-7368-e054-00144ff88e88 70957-0016 HUMAN OTC DRUG Vitiligo Organics Cullen corylifolium whole plant, Berberis vulgaris root bark, Nigella sativa seed, Organic coconut oil OINTMENT TOPICAL 20160907 UNAPPROVED HOMEOPATHIC Organic Care Australia Pty LTD BERBERIS VULGARIS ROOT BARK; CULLEN CORYLIFOLIUM WHOLE; NIGELLA SATIVA SEED; COCONUT OIL 83; 83; 83; 752 mg/125mL; mg/125mL; mg/125mL; mg/125mL E 20171231 70959-0001_3c5a737d-685b-6cba-e054-00144ff8d46c 70959-0001 HUMAN OTC DRUG HELLO CARE MOISTURIZING AMPOULE MASK Adenosine, Niacinamide PATCH TOPICAL 20160801 UNAPPROVED DRUG OTHER WORLD PACK CO., LTD. NIACINAMIDE; ADENOSINE 2; .04 g/100g; g/100g E 20171231 70959-0002_3c5a737d-6868-6cba-e054-00144ff8d46c 70959-0002 HUMAN OTC DRUG HELLO CARE PORE AND SEBUM AMPOULE MASK Adenosine, Niacinamide PATCH TOPICAL 20160801 UNAPPROVED DRUG OTHER WORLD PACK CO., LTD. NIACINAMIDE; ADENOSINE 2; .04 g/100g; g/100g E 20171231 70959-0003_3cb40f45-2dc6-16ea-e054-00144ff88e88 70959-0003 HUMAN OTC DRUG HELLO CARE WHITENING AMPOULE MASK ADENOSINE, NIACINAMIDE PATCH TOPICAL 20160913 UNAPPROVED DRUG OTHER WORLD PACK CO., LTD. ADENOSINE; NIACINAMIDE .04; 2 g/100g; g/100g E 20171231 70959-0004_3cb40f45-2dcf-16ea-e054-00144ff88e88 70959-0004 HUMAN OTC DRUG HELLO CARE ANTI-WRINKLE AMPOULE MASK ADENOSINE, NIACINAMIDE PATCH TOPICAL 20160913 UNAPPROVED DRUG OTHER WORLD PACK CO., LTD. ADENOSINE; NIACINAMIDE .04; 2 g/100g; g/100g E 20171231 70960-682_4830e546-7dab-3fb5-e054-00144ff8d46c 70960-682 HUMAN OTC DRUG PHACE BIOACTIVE SOOTHING DAY Plus PRIMER BROAD-SPECTRUM SPF 46 OCTINOXATE, ZINC OXIDE LOTION TOPICAL 20140319 OTC MONOGRAPH NOT FINAL part352 Vara International Inc. OCTINOXATE; ZINC OXIDE 75; 90 mg/mL; mg/mL N 20181231 70960-683_4830e546-7dbb-3fb5-e054-00144ff8d46c 70960-683 HUMAN OTC DRUG PHACE BIOACTIVE CLARIFYING SERUM SALICYLIC ACID CREAM TOPICAL 20160913 OTC MONOGRAPH FINAL part333D Vara International Inc. SALICYLIC ACID 15 mg/mL N 20181231 70961-0001_3cc80bdc-214c-3d1b-e054-00144ff88e88 70961-0001 HUMAN OTC DRUG DEEPAIR MICRO INTENSIVE MAGIC Sodium Hyaluronate, Acetyl Octapeptide-3, Madecassoside PATCH TOPICAL 20160801 UNAPPROVED DRUG OTHER Acosmetic. Co.ltd HYALURONATE SODIUM 6.1 g/100mg N 20181231 70961-0002_3cc9fddb-d1f7-463f-e054-00144ff8d46c 70961-0002 HUMAN OTC DRUG DEEPAIR MICRO INTENSIVE MAGIC Adenosine CREAM TOPICAL 20160801 UNAPPROVED DRUG OTHER Acosmetic. Co.ltd ADENOSINE .04 g/100mL N 20181231 70963-001_3e9ecbb5-64c8-4811-e054-00144ff88e88 70963-001 HUMAN OTC DRUG FLUIDBASE MAX Glycerin CREAM TOPICAL 20161011 OTC MONOGRAPH FINAL part347 LABORATORIO GENOVE S.A. GLYCERIN 10.5 mg/mL E 20171231 70963-002_3956632c-c6b0-2a0f-e054-00144ff8d46c 70963-002 HUMAN OTC DRUG FLUIDBASE AHA 10 Glyceryl Stearate LOTION TOPICAL 20160805 UNAPPROVED DRUG OTHER LABORATORIO GENOVE S.A. GLYCERYL STEARATE SE .45 mg/mL E 20171231 70963-003_3f528124-27f3-426a-e054-00144ff8d46c 70963-003 HUMAN OTC DRUG FLUIDBASE RETINOL VIT C Dimethicone LOTION TOPICAL 20161022 OTC MONOGRAPH FINAL part347 LABORATORIO GENOVE S.A. DIMETHICONE .5 mg/mL E 20171231 70964-0001_c72eece0-8505-409e-b9de-62cc63519975 70964-0001 HUMAN OTC DRUG Advance Plus Carduus Marianus, Cynara Scolymus, Solidago Virgaurea, Taraxacum Officinale, Benzoicum Acidum, Berberis Vulgaris, Bryonia (Alba), Cantharis, Carduus Benedictus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Cinchona Officinalis, Dioscorea Villosa, Dolichos Pruriens, Iris Versicolor, Juniperus Communis, Nux Vomica, Ptelea Trifoliata, Uricum Acidum SPRAY ORAL 20161208 UNAPPROVED HOMEOPATHIC VitaminMed, LLC MILK THISTLE; CYNARA SCOLYMUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CENTAUREA BENEDICTA; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DIOSCOREA VILLOSA TUBER; MUCUNA PRURIENS FRUIT TRICHOME; IRIS VERSICOLOR ROOT; JUNIPER BERRY; STRYCHNOS NUX-VOMICA SEED; PTELEA TRIFOLIATA BARK; URIC ACID 3; 3; 3; 3; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 70965-001_15aa8f4f-c91d-4d7a-80b2-c6feea80ba2f 70965-001 HUMAN OTC DRUG Mens PLATINUM Calcarea carbonica, Capsicum annuum, Ferrum metallicum, Glandula suprarenalis, Graphites, Hepar suis, Hypothalamus, Kali carbonicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Pancreatinum, Phytolacca decandra, Orchitinum. LIQUID ORAL 20161010 UNAPPROVED HOMEOPATHIC Breakthrough M2 Inc OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; IRON; SUS SCROFA ADRENAL GLAND; GRAPHITE; PORK LIVER; BOS TAURUS HYPOTHALAMUS; POTASSIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PANCRELIPASE; PHYTOLACCA AMERICANA ROOT; SUS SCROFA TESTICLE 12; 6; 12; 8; 12; 10; 18; 6; 12; 12; 30; 12; 12; 8 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 70965-002_745e6463-aac2-407c-8cf2-5627eed597a3 70965-002 HUMAN OTC DRUG Womens PLATINUM Calcarea carbonica, Capsicum annuum, Ferrum metallicum, Glandula suprarenalis, Graphites, Hepar suis, Hypothalamus, Iodium, Kali carbonicum, Oophorinum, Pancreatinum, Phytolacca decandra, Pulsatilla, Sepia. LIQUID ORAL 20161010 UNAPPROVED HOMEOPATHIC Breakthrough M2 Inc OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; IRON; SUS SCROFA ADRENAL GLAND; GRAPHITE; PORK LIVER; BOS TAURUS HYPOTHALAMUS; IODINE; POTASSIUM CARBONATE; SUS SCROFA OVARY; PANCRELIPASE; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE 12; 6; 12; 8; 12; 10; 18; 6; 6; 8; 12; 12; 30; 30 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 70969-100_9e6ff4ee-8378-47d6-9a56-8fa78eddd01e 70969-100 HUMAN OTC DRUG Ginseng Niacinamide, Adenosine CREAM TOPICAL 20160914 UNAPPROVED DRUG OTHER Synbio Co., Ltd. NIACINAMIDE; ADENOSINE 1.5; .03 g/75g; g/75g E 20171231 70969-101_4e0201e0-d32f-473b-9ae9-a71d43f2fb1f 70969-101 HUMAN OTC DRUG Ginseng Whitening Niacinamide CREAM TOPICAL 20160919 UNAPPROVED DRUG OTHER Synbio Co., Ltd. NIACINAMIDE 2 g/50g E 20171231 70970-100_32460e24-386c-4b03-9a6a-9118cc66fdb4 70970-100 HUMAN OTC DRUG OHTrust Nano Ion Water Potassium hydroxide LIQUID TOPICAL 20160926 UNAPPROVED DRUG OTHER Nanoplus Limited (Cayman) Taiwan Branch POTASSIUM HYDROXIDE .2 g/100mL E 20171231 70971-3456_5c158d17-a9e9-a486-e053-2a91aa0ace20 70971-3456 HUMAN OTC DRUG PureOxyWash Hydrogen Peroxide 3% Baking Soda KIT DENTAL 20130324 UNAPPROVED DRUG OTHER PureOxyWash Inc N 20181231 70972-1200_546915c5-c845-49b9-91b6-693052ee576d 70972-1200 HUMAN OTC DRUG Sanitizing Wipes Benzalkonium chloride SWAB TOPICAL 20170404 OTC MONOGRAPH NOT FINAL part333A Wipes LLC BENZALKONIUM CHLORIDE .13 g/100g N 20181231 70975-001_295b503c-aa51-463e-b62d-09cc1092d99a 70975-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20160816 NDA NDA205865 Earlbeck Welding Supplies OXYGEN 995 mL/L N 20181231 70975-002_b3fc5d35-ac32-4f71-ac40-5a680d6bf352 70975-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20160816 NDA NDA205866 Earlbeck Welding Supplies NITROGEN 995 mL/L N 20181231 70976-001_3da11977-a2d2-74ae-e054-00144ff8d46c 70976-001 HUMAN OTC DRUG KLAVUU RED PEARLSATION UV Protection City Defencer SPF50 OCTINOXATE, HOMOSALATE, OCTISALATE CREAM TOPICAL 20160917 OTC MONOGRAPH NOT FINAL part352 Bekeikorea OCTINOXATE; HOMOSALATE; OCTISALATE 3.5; 3; 2.25 mg/50mL; mg/50mL; mg/50mL N 20181231 70976-002_3da127b9-90be-094f-e054-00144ff8d46c 70976-002 HUMAN OTC DRUG KLAVUU WHITE PEARLSATION Ideal Actress Backstage Cream SPF30 OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20160917 OTC MONOGRAPH NOT FINAL part352 Bekeikorea OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 2.01; 1.06; .075 mg/30mL; mg/30mL; mg/30mL N 20181231 70976-003_4392d593-ea37-1ce4-e054-00144ff88e88 70976-003 HUMAN OTC DRUG KLAVUU BLUEPEARLSATION High Coverage Marine Collagen Aqua Cushion 21 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE CREAM TOPICAL 20161212 OTC MONOGRAPH NOT FINAL part352 Bekeikorea TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE; OCTISALATE 1.06; .84; .59; .54 g/12g; g/12g; g/12g; g/12g N 20181231 70976-004_4393505f-2104-6c8d-e054-00144ff8d46c 70976-004 HUMAN OTC DRUG KLAVUU BLUEPEARLSATION High Coverage Marine Collagen Aqua Cushion 23 TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE CREAM TOPICAL 20161212 OTC MONOGRAPH NOT FINAL part352 Bekeikorea TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE; OCTISALATE 1.06; .84; .59; .54 g/12g; g/12g; g/12g; g/12g N 20181231 70976-005_57d4b372-3201-850b-e053-2991aa0a50f3 70976-005 HUMAN OTC DRUG KLAVUU CITY DEFENSE TONE CHANGE SUN CUSHION Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170824 OTC MONOGRAPH NOT FINAL part352 Bekeikorea ZINC OXIDE; TITANIUM DIOXIDE 1.164; .714 g/12g; g/12g N 20181231 70976-006_596aa9b3-0169-90fd-e053-2991aa0ab92a 70976-006 HUMAN OTC DRUG KLAVUU GREEN PEARLSATION TEATREE CARE SPOT CORRECTOR Salicylic Acid CREAM TOPICAL 20170913 OTC MONOGRAPH FINAL part333D Bekeikorea SALICYLIC ACID .025 mg/5mL N 20181231 70977-001_fd2f6f5c-4ab5-4408-9b66-b2d39b9da2e3 70977-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20161003 NDA NDA205865 Geer Gas Corporation OXYGEN 990 mL/L N 20181231 70977-002_d2ad1b12-ec51-4859-b30e-2ab795d8f821 70977-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20161003 NDA NDA205866 Geer Gas Corporation NITROGEN 99 L/L N 20181231 70983-001_c2a9d235-6cba-4fac-b55d-094446c9a43d 70983-001 HUMAN OTC DRUG Chest Comfort Menthol SALVE TOPICAL 20161016 OTC MONOGRAPH FINAL part341 Saje Natural Business Inc. MENTHOL 27.6 mg/g N 20181231 70983-002_429b3d98-ac84-4d02-bf84-9e7de68abdf3 70983-002 HUMAN OTC DRUG Fortify Menthol OIL TOPICAL 20161016 OTC MONOGRAPH FINAL part341 Saje Natural Business Inc. MENTHOL 24 mg/mL N 20181231 70983-003_3420d197-354b-4143-a0b4-150bee6d867f 70983-003 HUMAN OTC DRUG Sweet Comfort Menthol OIL TOPICAL 20161016 OTC MONOGRAPH FINAL part341 Saje Natural Business Inc. MENTHOL 24.56 mg/mL N 20181231 70983-004_2842feb5-d818-412b-9233-e53ddd49db72 70983-004 HUMAN OTC DRUG Pain Release Menthol GRANULE TOPICAL 20161016 OTC MONOGRAPH NOT FINAL part348 Saje Natural Business Inc. MENTHOL 1.6 mg/g N 20181231 70983-005_6b9c043e-680b-4c0d-94e0-0ce9eb9bf294 70983-005 HUMAN OTC DRUG Pain Release Menthol LIQUID TOPICAL 20161016 OTC MONOGRAPH NOT FINAL part348 Saje Natural Business Inc. MENTHOL 2.23 mg/mL N 20181231 70983-006_6061fbed-f571-4c2d-aa3f-42b52dd3ca0e 70983-006 HUMAN OTC DRUG Pain Release Menthol OIL TOPICAL 20161016 OTC MONOGRAPH NOT FINAL part348 Saje Natural Business Inc. MENTHOL 17.62 mg/mL N 20181231 70983-007_bb86b933-93b9-4237-b159-1a6035acf817 70983-007 HUMAN OTC DRUG Pain Release Menthol OIL TOPICAL 20161016 OTC MONOGRAPH NOT FINAL part348 Saje Natural Business Inc. MENTHOL 12.18 mg/mL N 20181231 70983-008_2e933d8b-a0cf-4e5e-8688-0237bd1425e1 70983-008 HUMAN OTC DRUG Recovery Menthol OINTMENT TOPICAL 20161016 OTC MONOGRAPH NOT FINAL part348 Saje Natural Business Inc. MENTHOL 12.7 mg/g N 20181231 70983-009_89a30e7f-07ee-4e67-8f12-93dd5a8700ef 70983-009 HUMAN OTC DRUG Trauma Less Menthol OINTMENT TOPICAL 20161016 OTC MONOGRAPH NOT FINAL part348 Saje Natural Business Inc. MENTHOL 12.7 mg/g N 20181231 70983-010_02e217f8-ea35-4da2-b42f-62d5c4dcc935 70983-010 HUMAN OTC DRUG Pain Release Menthol KIT 20161016 OTC MONOGRAPH NOT FINAL part348 Saje Natural Business Inc. N 20181231 70983-012_9e59ea08-f367-4140-93ab-0faa19d1a054 70983-012 HUMAN OTC DRUG Home Farmacy Menthol KIT 20161016 OTC MONOGRAPH FINAL part341 Saje Natural Business Inc. N 20181231 70983-013_1be016b8-50c7-498a-bd5d-18e3ce4dca6f 70983-013 HUMAN OTC DRUG Pocket Farmacy Menthol KIT 20161016 OTC MONOGRAPH FINAL part341 Saje Natural Business Inc. N 20181231 70983-014_6b2294d6-c267-4a78-845a-719d7d1297d7 70983-014 HUMAN OTC DRUG Pocket Farmacy Menthol KIT 20161016 OTC MONOGRAPH FINAL part341 Saje Natural Business Inc. N 20181231 70983-015_9ebd27ba-28d2-42c6-806f-9bac6c90b5e2 70983-015 HUMAN OTC DRUG Rolling Farmacy Menthol KIT 20161016 OTC MONOGRAPH FINAL part341 Saje Natural Business Inc. N 20181231 70983-016_0d5fdd1a-36c8-4103-89b3-0db0b55c9bb3 70983-016 HUMAN OTC DRUG Comfort and Ease Menthol KIT 20161016 OTC MONOGRAPH FINAL part341 Saje Natural Business Inc. N 20181231 70983-017_0cf78c45-128b-4144-a1a5-902c632a1d2e 70983-017 HUMAN OTC DRUG Road to Wellness Menthol KIT 20161016 OTC MONOGRAPH NOT FINAL part348 Saje Natural Business Inc. N 20181231 70983-018_c8b051ee-7758-4fd5-a887-34675a218304 70983-018 HUMAN OTC DRUG Complete Fortify Menthol KIT 20170101 OTC MONOGRAPH FINAL part341 Saje Natural Business Inc. N 20181231 70983-020_5b7120b6-f36a-757f-e053-2a91aa0a2eea 70983-020 HUMAN OTC DRUG Traveling Farmacy Menthol KIT TOPICAL 20171101 OTC MONOGRAPH FINAL part341,part348 Saje Natural Business Inc. N 20181231 70983-022_62ea02eb-3340-9289-e053-2a91aa0a778f 70983-022 HUMAN OTC DRUG Restoral Menthol OINTMENT TOPICAL 20180201 OTC MONOGRAPH NOT FINAL part348 Saje Natural Business Inc. MENTHOL .2 g/100g N 20191231 70984-001_b88fb921-dd26-4b22-88be-a7c0d5577636 70984-001 HUMAN OTC DRUG Raging Kakapo Pain Relieve capsaisin and histamine dihydrochloride CREAM TOPICAL 20171025 OTC MONOGRAPH NOT FINAL part348 EffiHealth LLC CAPSAICIN; HISTAMINE DIHYDROCHLORIDE .25; .75 mg/g; mg/g N 20181231 70985-001_2da57941-32fa-4c4a-ba69-2fddd379e4d5 70985-001 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20161108 ANDA ANDA077829 Drug Ocean LLC CETIRIZINE HYDROCHLORIDE 5 mg/1 N 20181231 70985-002_46a7f920-784a-4d14-92f4-51dd6674d364 70985-002 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20161108 ANDA ANDA077829 Drug Ocean LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 70990-001_60f8e51d-8874-4698-9d8d-f3ca74d01785 70990-001 HUMAN OTC DRUG Bathscriptions Daily Moisturizing Dimethicone LOTION TOPICAL 20161012 OTC MONOGRAPH FINAL part347 Donegal Bay Ltd DIMETHICONE 2 g/100mL E 20171231 70990-002_f64728fc-302c-4e7f-9df7-5448cd7fa67f 70990-002 HUMAN OTC DRUG Footscriptions Foot Repair MENTHOL CREAM TOPICAL 20161012 OTC MONOGRAPH NOT FINAL part348 Donegal Bay Ltd MENTHOL .1 g/100mL E 20171231 70990-003_b8f0144e-5986-41b0-a283-3384bbc4117e 70990-003 HUMAN OTC DRUG Ethereal Skin Calming Moisturizing Cream DIMETHICONE CREAM TOPICAL 20161019 OTC MONOGRAPH FINAL part347 Donegal Bay Ltd DIMETHICONE 2 g/100mL E 20171231 70990-004_2e9e8f7a-c70b-433f-b958-37ea2c2ec374 70990-004 HUMAN OTC DRUG Hydra Bond Maximum Skin Therapy Cream DIMETHICONE CREAM TOPICAL 20161019 OTC MONOGRAPH FINAL part347 Donegal Bay Ltd DIMETHICONE 2 g/100mL E 20171231 70991-010_72ebf59b-447e-4932-8509-b3f8c75cdb7a 70991-010 HUMAN OTC DRUG Fascy Moisture Bomb Hand Cre am Grapefruit Dimethicone CREAM TOPICAL 20160801 OTC MONOGRAPH FINAL part347 FASCY Co,.LTD. DIMETHICONE .8 g/80mL N 20181231 70991-020_909ee639-fbc7-42ae-b629-ccc7e513aff7 70991-020 HUMAN OTC DRUG Fascy Moisture Bomb Hand Cre am Peach Dimethicone CREAM TOPICAL 20160801 OTC MONOGRAPH FINAL part347 FASCY Co,.LTD. DIMETHICONE .8 g/80mL N 20181231 70991-030_5be4a704-b85a-44ef-adc3-0608106f2d4b 70991-030 HUMAN OTC DRUG Fascy Moisture Bomb Hand Cre am Strawberry Dimethicone CREAM TOPICAL 20160801 OTC MONOGRAPH FINAL part347 FASCY Co,.LTD. DIMETHICONE .8 g/80mL N 20181231 70991-040_1001dc9c-2b8c-42a5-a5dd-021dac3199ad 70991-040 HUMAN OTC DRUG Fascy Moisture Bomb Hand Cre am Milk Dimethicone CREAM TOPICAL 20160801 OTC MONOGRAPH FINAL part347 FASCY Co,.LTD. DIMETHICONE .8 g/80mL N 20181231 70991-050_e6993a1d-a9df-4c7e-9137-3e2b5830a759 70991-050 HUMAN OTC DRUG Fascy Moisture Bomb Hand Cre am Violet Dimethicone CREAM TOPICAL 20160801 OTC MONOGRAPH FINAL part347 FASCY Co,.LTD. DIMETHICONE .8 g/80mL N 20181231 70991-060_0839a565-e577-4527-a146-4363380536a9 70991-060 HUMAN OTC DRUG Fascy Moisture Bomb Hand Violet 40mL Dimethicone CREAM TOPICAL 20170201 OTC MONOGRAPH FINAL part347 FASCY Co,.LTD. DIMETHICONE .4 g/40mL N 20181231 70991-070_00a93be3-d16e-45a0-91d4-b2746753f0f2 70991-070 HUMAN OTC DRUG Fascy Moisture Bomb Hand Milk 40mL Dimethicone CREAM TOPICAL 20170201 OTC MONOGRAPH FINAL part347 FASCY Co,.LTD. DIMETHICONE .4 g/40mL N 20181231 70991-080_2afbf1df-cc7a-4471-ac84-2b0247b7934c 70991-080 HUMAN OTC DRUG Fascy Moisture Bomb Hand Strawberry 40mL Dimethicone CREAM TOPICAL 20170201 OTC MONOGRAPH FINAL part347 FASCY Co,.LTD. DIMETHICONE .4 g/40mL N 20181231 70991-090_8ea794c7-556f-4e7f-8a8b-54dfdbc3266f 70991-090 HUMAN OTC DRUG Fascy Moisture Bomb Hand Peach 40mL Dimethicone CREAM TOPICAL 20170201 OTC MONOGRAPH FINAL part347 FASCY Co,.LTD. DIMETHICONE .4 g/40mL N 20181231 70991-100_c45cf077-5254-4d41-b573-8139fd0e1c87 70991-100 HUMAN OTC DRUG Fascy Moisture Bomb Hand Grapefruit 40mL Dimethicone CREAM TOPICAL 20170201 OTC MONOGRAPH FINAL part347 FASCY Co,.LTD. DIMETHICONE .4 g/40mL N 20181231 70992-101_47a1dd4f-9fe4-4fcb-b369-b9a2e01ae08c 70992-101 HUMAN OTC DRUG POWERFUL PAIN RELIEF ARNICA MONTANA CREAM TOPICAL 20160921 UNAPPROVED HOMEOPATHIC BACK TO NORMAL, LLC ARNICA MONTANA 1 [hp_X]/100g E 20171231 70993-0001_3ea2edd4-6a8b-0d97-e054-00144ff8d46c 70993-0001 HUMAN OTC DRUG ATONO2 Oxygen Mothers Cream Niacinamide , Adenosine CREAM TOPICAL 20141101 UNAPPROVED DRUG OTHER LAORGANIC Co., Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL E 20171231 70993-0002_3eb58772-56e7-09a5-e054-00144ff8d46c 70993-0002 HUMAN OTC DRUG ATONO2 BABY AROMA Helianthus Annuus (Sunflower) Seed Oil, Macadamia Ternifolia seed Oil OIL TOPICAL 20141101 UNAPPROVED DRUG OTHER LAORGANIC Co., Ltd. SUNFLOWER OIL; MACADAMIA OIL 14; 11 g/100mL; g/100mL E 20171231 70993-0003_3eb6d0de-cea9-3db8-e054-00144ff8d46c 70993-0003 HUMAN OTC DRUG ATONO2 Baby Sun Cream Ethylhexyl Methoxycinnamate, Titanium Dioxide CREAM TOPICAL 20160901 OTC MONOGRAPH FINAL part352 LAORGANIC Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE 2.97; 7 g/100g; g/100g E 20171231 70993-0004_3eb7793f-53e6-3aec-e054-00144ff88e88 70993-0004 HUMAN OTC DRUG ATONO2 Oxygen Bubble Foam Glycerin LIQUID TOPICAL 20141101 UNAPPROVED DRUG OTHER LAORGANIC Co., Ltd. GLYCERIN 3.075 g/100mL E 20171231 70993-0005_3eb9693f-5bd1-4c3c-e054-00144ff8d46c 70993-0005 HUMAN OTC DRUG ATONO2 Oxygen Baby Betaine LOTION TOPICAL 20150901 UNAPPROVED DRUG OTHER LAORGANIC Co., Ltd. BETAINE .2 g/100g E 20171231 70993-0006_3eba374a-e04c-7525-e054-00144ff8d46c 70993-0006 HUMAN OTC DRUG ATONO2 Oxygen Baby Bath and Glycerin SHAMPOO TOPICAL 20150901 UNAPPROVED DRUG OTHER LAORGANIC Co., Ltd. GLYCERIN 3.075 g/100g E 20171231 70993-0009_3ec9d5b9-ebbe-4e0c-e054-00144ff88e88 70993-0009 HUMAN OTC DRUG ATONO2 Oxygen Pure Bath and Glycerin SHAMPOO TOPICAL 20150901 UNAPPROVED DRUG OTHER LAORGANIC Co., Ltd. GLYCERIN 3.845 g/100g E 20171231 70993-0010_3eca6476-eb76-6e71-e054-00144ff8d46c 70993-0010 HUMAN OTC DRUG ATONO2 Oxygen Baby Soothing Gel Glycerin GEL TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part347 LAORGANIC Co., Ltd. GLYCERIN 11.985 g/100g E 20171231 70993-0011_3ec99831-f146-4691-e054-00144ff8d46c 70993-0011 HUMAN OTC DRUG ATONO2 Oxygen Baby Cream Glycerin CREAM TOPICAL 20151001 OTC MONOGRAPH NOT FINAL part347 LAORGANIC Co., Ltd. GLYCERIN 8.06 g/100g E 20171231 70994-101_480bd260-3894-56e6-e054-00144ff8d46c 70994-101 HUMAN OTC DRUG First Aid Calendula officials, Stellaria media, St. Johns Wort, Rosemary Oil, Plantago major, Commiphora Myrrha, Comfrey Leaf, Salvia officinalis, Sunflower Oil SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF 1; 1; 1; 1; 1; 1; 1; 1 [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g N 20181231 70994-102_480d6a8f-ae72-30ec-e054-00144ff8d46c 70994-102 HUMAN OTC DRUG Pain Relief Arnica, Menthol Crystals, Cinnamon, Peppermint, Ginger, Rosemary SALVE TOPICAL 20160331 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC ARNICA MONTANA FLOWER 1 [hp_X]/17g N 20181231 70994-103_48329ee2-d8e0-2179-e054-00144ff8d46c 70994-103 HUMAN OTC DRUG Dry Skin Care Calendula officials Flowers, Chamollia Recutita Flowers, Viola Tricolor Leaf, Sambucus Nigra Flowers, Trifolium Pratense Flowers, Archillea Millefolium SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC CALENDULA OFFICINALIS FLOWER; CHAMOMILE; VIOLA TRICOLOR; TRIFOLIUM PRATENSE FLOWER; SAMBUCUS NIGRA FLOWER; ACHILLEA MILLEFOLIUM 1; 1; 1; 1; 1; 1 [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g N 20181231 70994-105_408119cb-6866-0b1b-e054-00144ff88e88 70994-105 HUMAN OTC DRUG Cold Sore Relief Stellaria media, Salvia officinalis, Calendula officials, St. Johns Wort, Rosemary Oil, Plantago major, Commiphora Myrrha, Comfrey Leaf, Salvia officinalis, Sunflower Oil SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF 1; 1; 1; 1; 1; 1; 1; 1 [hp_X]/19.8g; [hp_X]/19.8g; [hp_X]/19.8g; [hp_X]/19.8g; [hp_X]/19.8g; [hp_X]/19.8g; [hp_X]/19.8g; [hp_X]/19.8g N 20181231 70994-106_4833e5fb-d6f4-653c-e054-00144ff8d46c 70994-106 HUMAN OTC DRUG Solar Goo Zinc Oxide, Calendula Officinalis SALVE TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Sierra Sage Herbs LLC ZINC OXIDE; CALENDULA OFFICINALIS FLOWER 18; 1 g/113.4g; [hp_X]/113.4g N 20181231 70994-107_480ecd72-3917-0962-e054-00144ff8d46c 70994-107 HUMAN OTC DRUG Tattoo Care Calendula officials, Stellaria media, St. Johns Wort, Rosemary Oil, Plantago major, Commiphora Myrrha, Comfrey Leaf, Salvia officinalis, Sunflower Oil SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF 1; 1; 1; 1; 1; 1; 1; 1 [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g N 20181231 70994-201_45ee174c-939a-6f8f-e054-00144ff88e88 70994-201 HUMAN OTC DRUG Golf Goo Arnica, Menthol Crystals, Cinnamon, Peppermint, Ginger, Rosemary SALVE TOPICAL 20160331 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC ARNICA MONTANA FLOWER 1 [hp_X]/17g N 20181231 70994-202_480e32e4-42d2-606c-e054-00144ff8d46c 70994-202 HUMAN OTC DRUG Foot Care Calendula officials, Stellaria media, St. Johns Wort, Rosemary Oil, Plantago major, Commiphora Myrrha, Comfrey Leaf, Salvia officinalis, Sunflower Oil SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF 1; 1; 1; 1; 1; 1; 1; 1 [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g N 20181231 70994-203_480e32e4-42e0-606c-e054-00144ff8d46c 70994-203 HUMAN OTC DRUG Hand Goo Calendula officials, Stellaria media, St. Johns Wort, Rosemary Oil, Plantago major, Commiphora Myrrha, Comfrey Leaf, Salvia officinalis, Sunflower Oil SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF 1; 1; 1; 1; 1; 1; 1; 1 [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g N 20181231 70994-204_480ee4ba-a92d-07ee-e054-00144ff8d46c 70994-204 HUMAN OTC DRUG Poison Ivy Care Calendula officials, Stellaria media, St. Johns Wort, Rosemary Oil, Plantago major, Commiphora Myrrha, Comfrey Leaf, Salvia officinalis, Sunflower Oil SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF 1; 1; 1; 1; 1; 1; 1; 1 [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g N 20181231 70994-301_48878bce-cdf2-70db-e054-00144ff8d46c 70994-301 HUMAN OTC DRUG Animal First Aid Calendula officials, Stellaria media, St. Johns Wort, Rosemary Oil, Plantago major, Commiphora Myrrha, Comfrey Leaf, Salvia officinalis, Sunflower Oil SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF 1; 1; 1; 1; 1; 1; 1; 1 [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g N 20181231 70994-401_48c1c11d-296c-5e48-e054-00144ff8d46c 70994-401 HUMAN OTC DRUG Sweet Honey Lip Balm Zinc Oxide, Calendula officials flowers SALVE TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Sierra Sage Herbs LLC CALENDULA OFFICINALIS FLOWER; ZINC OXIDE 1; 3.6 [hp_X]/51.7g; g/51.7g N 20181231 70994-402_48c0b109-1e81-28e5-e054-00144ff8d46c 70994-402 HUMAN OTC DRUG Citrus Zest Lip Balm Calendula officials flowers SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC CALENDULA OFFICINALIS FLOWER 1 [hp_X]/51.7g N 20181231 70994-403_48c18663-cf64-576b-e054-00144ff88e88 70994-403 HUMAN OTC DRUG Cool Mint Lip Balm Calendula officials flowers SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC CALENDULA OFFICINALIS FLOWER 1 [hp_X]/51.7g N 20181231 70994-404_48c1c11d-292f-5e48-e054-00144ff8d46c 70994-404 HUMAN OTC DRUG Kiss-on Lip Balm Calendula officials flowers SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC CALENDULA OFFICINALIS FLOWER 1 [hp_X]/51.7g N 20181231 70994-501_48313e43-2460-5257-e054-00144ff8d46c 70994-501 HUMAN OTC DRUG Baby Balm Calendula officinalis, Chamomilla recutita, Archillea millefolium, Symphytum officinalis, Helianthus annuus SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC CALENDULA OFFICINALIS FLOWER; SYMPHYTUM OFFICINALE WHOLE; CHAMOMILE; ACHILLEA MILLEFOLIUM FLOWER 1; 1; 1; 1 [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g N 20181231 70994-503_4832b2c4-fc6c-26d6-e054-00144ff8d46c 70994-503 HUMAN OTC DRUG Nursing Cream Calendula officinalis, Chamomilla recutita, Althaea officinalis SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC ALTHAEA OFFICINALIS ROOT; CALENDULA OFFICINALIS FLOWER; CHAMOMILE 1; 1; 1 [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g N 20181231 70994-504_480e73ed-b79f-6ada-e054-00144ff88e88 70994-504 HUMAN OTC DRUG Childrens First Aid Calendula officials, Stellaria media, St. Johns Wort, Rosemary Oil, Plantago major, Commiphora Myrrha, Comfrey Leaf, Salvia officinalis, Sunflower Oil SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF 1; 1; 1; 1; 1; 1; 1; 1 [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g; [hp_X]/51.7g N 20181231 70994-605_460fc669-f2b8-3dc2-e054-00144ff88e88 70994-605 HUMAN OTC DRUG Sportsman Goo Calendula officials, Stellaria media, St. Johns Wort, Rosemary Oil, Plantago major, Commiphora Myrrha, Comfrey Leaf, Salvia officinalis, Sunflower Oil SALVE TOPICAL 20160401 UNAPPROVED HOMEOPATHIC Sierra Sage Herbs LLC ACHILLEA MILLEFOLIUM FLOWER; ST. JOHN'S WORT; STELLARIA MEDIA; CALENDULA OFFICINALIS FLOWER; PLANTAGO MAJOR; COMMIPHORA MYRRHA WHOLE; SALVIA OFFICINALIS WHOLE; COMFREY LEAF 1; 1; 1; 1; 1; 1; 1; 1 [hp_X]/17g; [hp_X]/17g; [hp_X]/17g; [hp_X]/17g; [hp_X]/17g; [hp_X]/17g; [hp_X]/17g; [hp_X]/17g N 20181231 70996-001_3f2a9499-986e-2b76-e054-00144ff88e88 70996-001 HUMAN OTC DRUG Blister Balm MENTHOL SALVE TOPICAL 20161018 OTC MONOGRAPH NOT FINAL part348 Floratech Botanicals, LLC MENTHOL 1.1 g/100g N 20181231 70996-003_442e8dd5-0c61-4cba-e054-00144ff8d46c 70996-003 HUMAN OTC DRUG Blister Balm MENTHOL 1% SALVE TOPICAL 20161221 OTC MONOGRAPH NOT FINAL part348 Floratech Botanicals, LLC MENTHOL 1 g/100g N 20181231 70996-004_8eed9d2b-718e-4ae5-a69d-f35c67f7714b 70996-004 HUMAN OTC DRUG Blister Balm Protective Lip Treatment Glycerin LIQUID TOPICAL 20170217 OTC MONOGRAPH FINAL part347 Floratech Botanicals, LLC GLYCERIN 25 g/100mL N 20181231 71003-001_ec8baea0-4012-4619-bb68-91cc10cd2fda 71003-001 HUMAN OTC DRUG Hemorrhoidal Anesthetic Glycerin, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, and Petrolatum CREAM TOPICAL 20161020 OTC MONOGRAPH FINAL part346 Purity Products GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM 144; 2.5; 10; 150 mg/g; mg/g; mg/g; mg/g N 20181231 71006-010_96b7b2bb-d7cf-4cc2-875f-671e50a70f00 71006-010 HUMAN OTC DRUG Rubelli Beauty Face Dimethicone, Witch Hazel PATCH TOPICAL 20160901 OTC MONOGRAPH FINAL part347 RUBELLI CO.,LTD DIMETHICONE; WITCH HAZEL .28; .1 g/20mL; g/20mL N 20181231 71006-020_22a4c65f-a7a3-4be7-812b-12c81ea4c6f9 71006-020 HUMAN OTC DRUG Rubelli Wine Hand Packs Glycerin PATCH TOPICAL 20160901 UNAPPROVED DRUG OTHER RUBELLI CO.,LTD GLYCERIN 1.5 g/50g N 20181231 71006-030_f538d9ed-c575-45c2-81c8-b1e5aa14f3f5 71006-030 HUMAN OTC DRUG Rubelli Wine Foot Packs Glycerin PATCH TOPICAL 20160901 UNAPPROVED DRUG OTHER RUBELLI CO.,LTD GLYCERIN 1.5 g/50g N 20181231 71006-040_f8c24de4-84d0-4f17-af07-8b2eb7d6632c 71006-040 HUMAN OTC DRUG RUBELLI Black Pearl Mask Niacinamide, Adenosine PATCH TOPICAL 20170601 UNAPPROVED DRUG OTHER RUBELLI CO.,LTD NIACINAMIDE; ADENOSINE .5; .01 g/25mL; g/25mL N 20181231 71006-050_c1dd7282-4da3-412a-831d-444ebe59f74b 71006-050 HUMAN OTC DRUG Rubelli Water Glow Sun Octinoxate, Octisalate, Titanium Dioxide CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 RUBELLI CO.,LTD OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 2; 1.6 g/40mL; g/40mL; g/40mL N 20181231 71006-060_ed0a5d50-f67a-40bf-a845-37a211e52f3c 71006-060 HUMAN OTC DRUG RUBELLI WATER GLOW ESSENCE Niacinamide, Adenosine SPRAY TOPICAL 20170901 UNAPPROVED DRUG OTHER RUBELLI CO.,LTD NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71011-001_621702a3-9d58-4663-e053-2991aa0a5f38 71011-001 HUMAN OTC DRUG HAND SANITIZER ALCOHOL GEL TOPICAL 20160929 OTC MONOGRAPH NOT FINAL part333A NingBo Huize Commodity Co.,Ltd. ALCOHOL 62 mL/100mL N 20191231 71011-002_621702a3-9d4f-4663-e053-2991aa0a5f38 71011-002 HUMAN OTC DRUG sunscreen lip balm PADIMATE O,OCTINOXATE STICK TOPICAL 20161008 OTC MONOGRAPH NOT FINAL part352 NingBo Huize Commodity Co.,Ltd. OCTINOXATE; PADIMATE O 4; 7.5 g/100g; g/100g N 20191231 71011-003_621702a3-9d46-4663-e053-2991aa0a5f38 71011-003 HUMAN OTC DRUG HAND SANITIZER ALCOHOL GEL TOPICAL 20160609 OTC MONOGRAPH NOT FINAL part333A NingBo Huize Commodity Co.,Ltd. ALCOHOL 62 mL/100mL N 20191231 71012-111_437ae79b-69a3-1985-e054-00144ff8d46c 71012-111 HUMAN OTC DRUG ActiveClean Ethanol SDA 3C 200 AEROSOL, SPRAY TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part333A CleanSpot, Inc. ALCOHOL 62 mL/mL E 20171231 71014-001_d408f71f-a000-41ac-8ad4-8bb212f4962a 71014-001 HUMAN OTC DRUG Elemental Resestance Broad Spectrum SPF 50 Vertra Octyl Methoxycinnamate, Oxybenzone, Titanium Dioxide, Zince Oxide CREAM TOPICAL 20161007 OTC MONOGRAPH FINAL part352 Eai-Jr286, Inc. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 6; 5; 6.3; 9.9 g/100g; g/100g; g/100g; g/100g N 20181231 71014-002_9d4c30db-faf0-4f4a-bc67-55a866562735 71014-002 HUMAN OTC DRUG Sunscreen Face SPF 28 Vertra Elemental Resistance Octinioxate, Octocrylene, Titanium Dioxide STICK TOPICAL 20161007 OTC MONOGRAPH FINAL part352 Eai-Jr286, Inc OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE 5; 5; 3 g/100g; g/100g; g/100g N 20181231 71014-003_cefc8e89-b83a-4f85-89e8-4519f6543ec6 71014-003 HUMAN OTC DRUG Foundation Broad Spectrum SPF 35 Natural Beige Vertra Titanium Dioxide STICK TOPICAL 20161007 OTC MONOGRAPH FINAL part352 Eai-Jr286, Inc. TITANIUM DIOXIDE 24.15 g/100g N 20181231 71014-004_1660da5e-ea68-4bbf-8e5e-5b331202a75e 71014-004 HUMAN OTC DRUG Foundation Sunscreen Face Broad Spectrum SPF 38 Vertra Elemental Resistance Titanium Dioxide STICK TOPICAL 20161007 OTC MONOGRAPH FINAL part352 Eai-jr 286, Inc TITANIUM DIOXIDE 24.15 g/100g N 20181231 71014-005_5acf9026-ade1-4492-8ea1-68b9ac1cdc12 71014-005 HUMAN OTC DRUG Translucent Broad Spectrum Foundation SPF 50 Vertra Padimate O, Titanium Dioxide STICK TOPICAL 20161007 OTC MONOGRAPH FINAL part352 Eai-Jr286, Inc. PADIMATE O; TITANIUM DIOXIDE 7; 17.45 g/100g; g/100g N 20181231 71014-006_d19dbab2-010b-4cf0-b1eb-8147000e7e07 71014-006 HUMAN OTC DRUG Elemental Resistance Broad Spectrum SPF 50 Vertra Octyl Methoxycinnamate, Oxybenzone, Titanium Dioxide, Zince Oxide CREAM TOPICAL 20161027 OTC MONOGRAPH FINAL part352 Eai-Jr286, Inc. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 6; 5; 6.3; 9.9 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 71014-007_506595ba-2eab-4fc7-bf21-676245e94df1 71014-007 HUMAN OTC DRUG Spearmint Lip Balm Broad Spectrum Vertra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20161122 OTC MONOGRAPH FINAL part352 Eai-Jr286, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 71014-008_5bb3066b-d719-484c-903d-cbc024c14336 71014-008 HUMAN OTC DRUG Beeswax Lip Balm SPF 30 Vertra Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone STICK TOPICAL 20161122 OTC MONOGRAPH FINAL part352 Eai-jr 286, Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 7.5; 5; 2.5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 71016-001_4d10287d-6bf2-37f3-e054-00144ff8d46c 71016-001 HUMAN OTC DRUG Doloran Menthol, Camphor, Methyl Salicylate OINTMENT TOPICAL 20161024 OTC MONOGRAPH NOT FINAL part348 Hector Rivera Garzon y Compania. S. en C. MENTHOL; CAMPHOR, (-)-; METHYL SALICYLATE .08; .08; .02 g/g; g/g; g/g N 20181231 71017-010_fc01060a-f412-4c00-8990-496a8e752d4d 71017-010 HUMAN OTC DRUG Frudia Blueberry Hydrating Dimethicone CREAM TOPICAL 20161001 OTC MONOGRAPH FINAL part347 WELCOS CO.,LTD. DIMETHICONE 1.39 g/55g N 20181231 71017-020_6e5ca01b-bf95-4e09-a6b9-96ad5276e190 71017-020 HUMAN OTC DRUG Frudia Green Grape Pore Control WINE GRAPE CREAM TOPICAL 20161001 UNAPPROVED DRUG OTHER WELCOS CO.,LTD. WINE GRAPE 44.75 g/55g N 20181231 71017-030_cedb8957-e959-4fba-8fcb-f8c1e29b851c 71017-030 HUMAN OTC DRUG Frudia Pomegranate Nutri Moisturizing Dimethicone CREAM TOPICAL 20161001 OTC MONOGRAPH FINAL part347 WELCOS CO.,LTD. DIMETHICONE 1.54 g/55g N 20181231 71017-040_190577e2-b031-4c62-827c-864646db2ccb 71017-040 HUMAN OTC DRUG Frudia Citrus Brightening TANGERINE PEEL, Niacinamide CREAM TOPICAL 20161001 UNAPPROVED DRUG OTHER WELCOS CO.,LTD. TANGERINE PEEL; NIACINAMIDE 33.69; 1.1 g/55g; g/55g N 20181231 71017-050_e8daf0ef-cbd6-464d-afea-f6c003c4068c 71017-050 HUMAN OTC DRUG Frudia Blueberry Hydrating Mask LOWBUSH BLUEBERRY PATCH TOPICAL 20161010 UNAPPROVED DRUG OTHER WELCOS CO.,LTD. LOWBUSH BLUEBERRY 14.9 g/27mL N 20181231 71017-060_8b2deaa4-6ea8-4b84-adfb-3aa0fb9897f2 71017-060 HUMAN OTC DRUG Frudia Citrus Brightening Mask TANGERINE PEEL, NIACINAMIDE PATCH TOPICAL 20161010 UNAPPROVED DRUG OTHER WELCOS CO.,LTD. TANGERINE PEEL; NIACINAMIDE 12.57; .54 g/27mL; g/27mL N 20181231 71017-070_e90e7ce8-7307-4a2e-a075-33c0c39a2a55 71017-070 HUMAN OTC DRUG Frudia Green Grape Pore Control Mask WINE GRAPE PATCH TOPICAL 20161010 UNAPPROVED DRUG OTHER WELCOS CO.,LTD. WINE GRAPE 16.23 g/27mL N 20181231 71017-080_6f17867e-9aa7-4827-a772-93e698c0a4e4 71017-080 HUMAN OTC DRUG Frudia Pomegranate Nutri Moisturizing Mask POMEGRANATE, ADENOSINE PATCH TOPICAL 20161010 UNAPPROVED DRUG OTHER WELCOS CO.,LTD. POMEGRANATE; ADENOSINE 12.57; .01 g/27mL; g/27mL N 20181231 71017-090_e76ec6e1-b285-4c66-ae44-db0203b5271b 71017-090 HUMAN OTC DRUG Frudia Citrus Brightening Toner TANGERINE PEEL, NIACINAMIDE LIQUID TOPICAL 20161010 UNAPPROVED DRUG OTHER WELCOS CO.,LTD. TANGERINE PEEL; NIACINAMIDE 168.5; 3.9 g/195mL; g/195mL N 20181231 71017-100_d31b979b-ee43-452b-be52-edf56c18e6e9 71017-100 HUMAN OTC DRUG Frudia Pomegranate Nutri Moisturizing Toner POMEGRANATE, ADENOSINE LIQUID TOPICAL 20161010 UNAPPROVED DRUG OTHER WELCOS CO.,LTD. POMEGRANATE; ADENOSINE 170.7; .07 g/195mL; g/195mL N 20181231 71017-110_a6ca210a-cf6c-4859-b363-ca098a89890d 71017-110 HUMAN OTC DRUG Frudia Green Grape Pore Control Toner WINE GRAPE LIQUID TOPICAL 20161010 UNAPPROVED DRUG OTHER WELCOS CO.,LTD. WINE GRAPE 174.1 g/195mL N 20181231 71017-120_23083bb5-e694-4cd8-9252-37940b63838e 71017-120 HUMAN OTC DRUG Frudia Blueberry Hydrating Serum LOWBUSH BLUEBERRY CREAM TOPICAL 20161010 UNAPPROVED DRUG OTHER WELCOS CO.,LTD. LOWBUSH BLUEBERRY 35.92 g/50g N 20181231 71017-130_8a658e20-fe77-4e13-8413-7c722a4358b5 71017-130 HUMAN OTC DRUG Frudia Citrus Brightening Serum Dimethicone CREAM TOPICAL 20161010 OTC MONOGRAPH FINAL part347 WELCOS CO.,LTD. DIMETHICONE 1.88 g/50g N 20181231 71017-140_d23b9842-e7d6-4118-b767-a7ea23f2f2d6 71017-140 HUMAN OTC DRUG Frudia Pomegranate Nutri Moisturizing Serum POMEGRANATE, ADENOSINE CREAM TOPICAL 20161010 UNAPPROVED DRUG OTHER WELCOS CO.,LTD. POMEGRANATE; ADENOSINE 31.99; .02 g/50g; g/50g N 20181231 71017-150_696a1e4a-5c54-4d96-a45f-98c846956ea5 71017-150 HUMAN OTC DRUG Frudia Green Grape Pore Control Serum Dimethicone CREAM TOPICAL 20161010 OTC MONOGRAPH FINAL part347 WELCOS CO.,LTD. DIMETHICONE .71 g/50g N 20181231 71017-160_29a94294-dfb5-4e7c-a4f2-1f8f49828e25 71017-160 HUMAN OTC DRUG Frudia Blueberry Hydrating Toner LOWBUSH BLUEBERRY LIQUID TOPICAL 20161010 UNAPPROVED DRUG OTHER WELCOS CO.,LTD. LOWBUSH BLUEBERRY 171.67 g/195mL N 20181231 71017-170_f7fda2e9-2da3-4890-8565-072de18a1c40 71017-170 HUMAN OTC DRUG Frudia Blueberry Hydrating Intensive Dimethicone CREAM TOPICAL 20161001 OTC MONOGRAPH FINAL part347 WELCOS CO.,LTD. DIMETHICONE 2.64 g/55g N 20181231 71018-002_f1e319ac-6fc5-4a60-a499-4205571e944e 71018-002 HUMAN OTC DRUG TH-101 Calc carb, Carbo veg, Chelidonium maj, CoQ10, Fucus, Graphites, Homeopathic glycoprotein complex, Hypothalamus, Kali phos, Lycopodium, Mag phos, Nat mur, Nat phos, Nux vom, Ornithogalum, Phytolacca, Pituitarum, Placenta, Sinapis arv flos, Quercus gland sp, Quercus rob LIQUID ORAL 20170508 UNAPPROVED HOMEOPATHIC Temple Health Nutrition, LLC OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; UBIDECARENONE; FUCUS VESICULOSUS; GRAPHITE; BOS TAURUS HYPOTHALAMUS; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRYCHNOS NUX-VOMICA SEED; ORNITHOGALUM UMBELLATUM; PHYTOLACCA AMERICANA ROOT; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; SINAPIS ARVENSIS FLOWERING/FRUITING TOP; QUERCUS ROBUR NUT; QUERCUS ROBUR TWIG BARK; SUCROSE; ARGININE; CYSTEINE; LEUCINE; PROLINE; SERINE; THREONINE; VALINE 12; 4; 6; 12; 4; 6; 12; 6; 6; 6; 6; 12; 6; 6; 6; 12; 12; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 71020-001_64043b8c-8278-680b-e053-2991aa0afec8 71020-001 HUMAN OTC DRUG Antibacterial Benzalkonium Chloride LIQUID TOPICAL 20161008 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 71020-002_3e5c387e-7e1e-5998-e054-00144ff88e88 71020-002 HUMAN OTC DRUG Antibacterial Benzalkonium Chloride LIQUID TOPICAL 20161008 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 71020-003_64044131-6cbe-5ab3-e053-2a91aa0a6499 71020-003 HUMAN OTC DRUG Antibacterial Benzalkonium Chloride LIQUID TOPICAL 20161008 OTC MONOGRAPH NOT FINAL part333A Sante Manufcaturing Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 71020-004_6404677b-88b5-ca86-e053-2991aa0a021d 71020-004 HUMAN OTC DRUG Antibacterial Benzalkonium Chloride LIQUID TOPICAL 20161008 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 71020-005_64043b8c-8283-680b-e053-2991aa0afec8 71020-005 HUMAN OTC DRUG Antibacterial 2X Benzalkonium Chloride LIQUID TOPICAL 20161008 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 71020-006_3f3828e5-bb39-7207-e054-00144ff88e88 71020-006 HUMAN OTC DRUG Antibacterial Triclosan LIQUID TOPICAL 20161019 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc TRICLOSAN 1.15 mg/mL E 20171231 71020-007_3f3918f5-78af-73b7-e054-00144ff88e88 71020-007 HUMAN OTC DRUG Antibacterial Triclosan LIQUID TOPICAL 20161019 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc TRICLOSAN 1.15 mg/mL E 20171231 71020-008_3fc568c2-05bf-283e-e054-00144ff8d46c 71020-008 HUMAN OTC DRUG Antibacterial Triclosan LIQUID TOPICAL 20161019 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc TRICLOSAN 1.15 mg/mL E 20171231 71020-009_3f4582db-1c3c-4e81-e054-00144ff88e88 71020-009 HUMAN OTC DRUG Antibacterial 2X Triclosan LIQUID TOPICAL 20161019 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc TRICLOSAN 1.15 mg/mL E 20171231 71020-010_4a6d6d3e-5498-0d28-e054-00144ff8d46c 71020-010 HUMAN OTC DRUG Aloe Touch Hand Sanitizer LIQUID TOPICAL 20170310 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc ALCOHOL 700 mL/1000mL N 20181231 71020-011_4a6ef6ff-d508-3d47-e054-00144ff88e88 71020-011 HUMAN OTC DRUG Unscented Hand Sanitizer LIQUID TOPICAL 20170311 OTC MONOGRAPH NOT FINAL part333A Sante Maufacturing Inc ALCOHOL 700 mL/1000mL N 20181231 71020-012_4a6e5fd0-7f28-3908-e054-00144ff8d46c 71020-012 HUMAN OTC DRUG Lavender Hand Sanitizer LIQUID TOPICAL 20170311 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc ALCOHOL 700 mL/1000mL N 20181231 71020-013_4a6fee31-dd6f-6ad6-e054-00144ff8d46c 71020-013 HUMAN OTC DRUG Unscented Hand Sanitizer LIQUID TOPICAL 20170311 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc ALCOHOL 700 mL/1000mL N 20181231 71020-014_4a702a6e-08a9-55f9-e054-00144ff88e88 71020-014 HUMAN OTC DRUG Unscented Refill Hand Sanitizer LIQUID TOPICAL 20170311 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc ALCOHOL 700 mL/1000mL N 20181231 71020-015_4a77f5e6-7269-0cdb-e054-00144ff8d46c 71020-015 HUMAN OTC DRUG SpaSoap Hand Sanitizer LIQUID TOPICAL 20170311 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc ALCOHOL 700 mL/1000mL N 20181231 71020-016_6404695c-2ca0-97f7-e053-2a91aa0af1a5 71020-016 HUMAN OTC DRUG Antibacterial 2X Benzalkonium Chloride LIQUID TOPICAL 20180130 OTC MONOGRAPH NOT FINAL part333A Sante Manufacturing Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 71023-445_3ed57316-5721-00cf-e054-00144ff88e88 71023-445 HUMAN OTC DRUG Afia Alcohol-Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE SOAP TOPICAL 20161024 OTC MONOGRAPH NOT FINAL part333A National Chemical Laboratories, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 71023-446_3ed2bd59-213c-116d-e054-00144ff88e88 71023-446 HUMAN OTC DRUG Afia Foaming Anti-Bacterial Hand Cleaner CHLOROXYLENOL SOAP TOPICAL 20161024 OTC MONOGRAPH NOT FINAL part333A National Chemical Laboratories, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 71023-448_466478c7-ea22-0f6c-e054-00144ff88e88 71023-448 HUMAN OTC DRUG Afia Foaming E2 Sanitizing Hand Cleaner BENZALKONIUM CHLORIDE SOAP TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part333A National Chemical Laboratories, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 71026-001_66bda694-2e4b-4b6f-912c-9e948c69860b 71026-001 HUMAN OTC DRUG YADAH OH MY SUN BLOCK OCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 YADAH Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; OCTOCRYLENE; AVOBENZONE 3.75; 1.065; 1; .6 mg/50mL; mg/50mL; mg/50mL; mg/50mL N 20191231 71026-002_752c2e76-82af-4f60-8060-2fb77d5adeab 71026-002 HUMAN OTC DRUG YADAH SILKY FIT CONCEALER BB POWER BRIGHTENING OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part352 YADAH Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 89; 75; 50; 19.6 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71026-003_52033549-e872-5f22-e054-00144ff8d46c 71026-003 HUMAN OTC DRUG Yadah Anti Trouble Bubble Cleanser Salicylic Acid GEL TOPICAL 20170613 OTC MONOGRAPH FINAL part333D YADAH Co., Ltd. SALICYLIC ACID .75 mg/150mL N 20181231 71026-004_566eacac-f189-2955-e054-00144ff88e88 71026-004 HUMAN OTC DRUG YADAH OH MY SUN SLUSH HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20170802 OTC MONOGRAPH NOT FINAL part352 YADAH Co., Ltd. HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 95; 50; 45; 30 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71026-005_566eacac-f193-2955-e054-00144ff88e88 71026-005 HUMAN OTC DRUG YADAH TWIN ANGEL BB TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20170802 OTC MONOGRAPH NOT FINAL part352 YADAH Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 95.4; 48.6; 28.6 mg/mL; mg/mL; mg/mL N 20181231 71026-006_566ebc98-0e3d-726c-e054-00144ff8d46c 71026-006 HUMAN OTC DRUG YADAH AIRPOWDER PACT 19 LIGHT BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20170802 OTC MONOGRAPH NOT FINAL part352 YADAH Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 85.4; 60; 29.4 mg/g; mg/g; mg/g N 20181231 71026-007_566eacac-f19d-2955-e054-00144ff88e88 71026-007 HUMAN OTC DRUG YADAH AIRPOWDER PACT 21 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20170802 OTC MONOGRAPH NOT FINAL part352 YADAH Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 85.4; 60; 29.4 mg/g; mg/g; mg/g N 20181231 71026-008_566eacac-f1a7-2955-e054-00144ff88e88 71026-008 HUMAN OTC DRUG YADAH BE MY CUSHION 21 LIGHT BEIGE TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE CREAM TOPICAL 20170802 OTC MONOGRAPH NOT FINAL part352 YADAH Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 90; 70; 48; 20; 20 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 71026-009_566eacac-f1b2-2955-e054-00144ff88e88 71026-009 HUMAN OTC DRUG YADAH BE MY CUSHION 23 NATURAL BEIGE TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE CREAM TOPICAL 20170802 OTC MONOGRAPH NOT FINAL part352 YADAH Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 90; 70; 48; 20; 20 mg/g; mg/g; mg/g; mg/g; mg/g N 20181231 71027-019_097e4c7b-b447-4728-b012-49d6562f3373 71027-019 HUMAN OTC DRUG Rapid Max Maximum Strength Cool and Clear - Cold, Flu and Sore throat Rapid Max Maximum Strength Cool and Clear - Cold, Flu and Sore throat LIQUID ORAL 20170301 OTC MONOGRAPH FINAL part341 KINGSTON PHARMA LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL N 20181231 71027-020_23c16cf9-b0c9-475c-8014-fca9a843ff56 71027-020 HUMAN OTC DRUG Rapid Max Maximum Strength Cool and Clear - Cold, Severe Congestion and Cough Rapid Max Maximum Strength Cool and Clear - Cold, Severe Congestion and Cough LIQUID ORAL 20170301 OTC MONOGRAPH FINAL part341 KINGSTON PHARMA LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 20; 400; 10 mg/20mL; mg/20mL; mg/20mL N 20181231 71027-032_79bd8e8f-7f05-4de4-8bbb-4b379df78957 71027-032 HUMAN OTC DRUG Childrens Tussin DM Childrens Tussin DM LIQUID ORAL 20170301 OTC MONOGRAPH FINAL part341 KINGSTON PHARMA LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 5; 100 mg/5mL; mg/5mL N 20181231 71027-040_5f7ad8db-c9f9-4462-99a7-eee24bd0cb62 71027-040 HUMAN OTC DRUG Daytime Cough Daytime Cough LIQUID ORAL 20170301 OTC MONOGRAPH FINAL part341 KINGSTON PHARMA LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 71027-041_de9c6c1d-ff69-49c2-8c18-2a556d229836 71027-041 HUMAN OTC DRUG NITETIME COUGH NITETIME COUGH LIQUID ORAL 20170301 OTC MONOGRAPH FINAL part341 KINGSTON PHARMA LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/15mL; mg/15mL; mg/15mL N 20181231 71027-047_df3e9800-72c8-4f3a-a25c-89971684ed99 71027-047 HUMAN OTC DRUG Childrens Cough and Cold Childrens Cough and Cold LIQUID ORAL 20170301 OTC MONOGRAPH FINAL part341 KINGSTON PHARMA LLC BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL N 20181231 71028-1000_64303ea8-c1b8-136d-e053-2991aa0accf9 71028-1000 HUMAN OTC DRUG Double Care Magic Serum Dimethicone LIQUID TOPICAL 20180129 OTC MONOGRAPH FINAL part347 SUNJIN BEAUTY SCIENCE CO.,LTD. DIMETHICONE 1.5 g/30mL N 20191231 71028-1001_64304fdd-bec0-ee1f-e053-2991aa0a874c 71028-1001 HUMAN OTC DRUG Triple Care Sports Milk Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate CREAM TOPICAL 20180129 OTC MONOGRAPH NOT FINAL part352 SUNJIN BEAUTY SCIENCE CO.,LTD. OCTINOXATE; OCTISALATE 1.95; 1.2 g/30mL; g/30mL N 20191231 71029-390_58d5f2b6-6625-4f43-9328-781a83edc1e3 71029-390 HUMAN OTC DRUG Sterile Antibacterial Wound Wash Benzethonium Chloride SPRAY TOPICAL 20170509 OTC MONOGRAPH NOT FINAL part333A Cosrich Group, Inc. BENZETHONIUM CHLORIDE 1.3 mg/mL N 20181231 71033-002_1af633a1-4cd6-478e-a4f3-9d3206cfe65d 71033-002 HUMAN OTC DRUG METABOLIC Adeps suillus, Adrenocorticotrophin, Agrimonia eupatoria flos, Ammonium bromatum, Anacardium orientale, Antimonium crudum, Calcarea carbonica, Coenzyme A, Cortisone aceticum, Fucus vesiculosus, Hypothalamus, Kali bichromicum, Oleander, Pituitarum posterium, RNA, Sabadilla, Staphysagria, Thyroidinum LIQUID ORAL 20161110 UNAPPROVED HOMEOPATHIC MEDICAL WEIGHT LOSS INSTITUTE LARD; CORTICOTROPIN; AGRIMONIA EUPATORIA FLOWER; AMMONIUM BROMIDE; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COENZYME A; CORTISONE ACETATE; FUCUS VESICULOSUS; BOS TAURUS HYPOTHALAMUS; POTASSIUM DICHROMATE; NERIUM OLEANDER LEAF; SUS SCROFA PITUITARY GLAND; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL E 20171231 71034-001_5bcc9272-c12e-3244-e053-2a91aa0a830b 71034-001 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET, EXTENDED RELEASE ORAL 20171201 ANDA ANDA209757 Xiamen LP Pharmaceutical Co., Ltd. CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 71035-200_62175f7d-6bea-2fb8-e053-2991aa0adb4b 71035-200 HUMAN OTC DRUG Charm Tex Fluoride SODIUM FLUORIDE PASTE DENTAL 20161020 OTC MONOGRAPH FINAL part355 Yangzhou Hongshengding Chemical Co.,Ltd. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20191231 71035-300_62175f7d-6bcf-2fb8-e053-2991aa0adb4b 71035-300 HUMAN OTC DRUG MintBlast Anti Cavity Fluoride Sodium Fluoride PASTE DENTAL 20160211 OTC MONOGRAPH NOT FINAL part356 Yangzhou Hongshengding Chemical Co.,Ltd. SODIUM FLUORIDE .243 g/100g N 20191231 71035-400_62175f7d-6bd8-2fb8-e053-2991aa0adb4b 71035-400 HUMAN OTC DRUG Fluoride Gel Sodium Fluoride PASTE DENTAL 20150501 OTC MONOGRAPH NOT FINAL part356 Yangzhou Hongshengding Chemical Co.,Ltd. SODIUM FLUORIDE .22 g/100g N 20191231 71035-500_62175f7d-6be1-2fb8-e053-2991aa0adb4b 71035-500 HUMAN OTC DRUG toothpowder Sodium Fluoride POWDER DENTAL 20160904 OTC MONOGRAPH NOT FINAL part356 Yangzhou Hongshengding Chemical Co.,Ltd. SODIUM FLUORIDE .24 g/100g N 20191231 71035-600_62175f7d-6bbd-2fb8-e053-2991aa0adb4b 71035-600 HUMAN OTC DRUG Plak Smacker Anti Cavity Fluoride Sodium Fluoride PASTE DENTAL 20160211 OTC MONOGRAPH NOT FINAL part356 Yangzhou Hongshengding Chemical Co.,Ltd. SODIUM FLUORIDE .24 g/100g N 20191231 71035-700_62175f7d-6bc6-2fb8-e053-2991aa0adb4b 71035-700 HUMAN OTC DRUG Plak Smacker Anti Cavity Fluoride Sodium Fluoride PASTE DENTAL 20160211 OTC MONOGRAPH NOT FINAL part356 Yangzhou Hongshengding Chemical Co.,Ltd. SODIUM FLUORIDE .24 g/100g N 20191231 71035-800_5250b063-8d76-2a8e-e054-00144ff8d46c 71035-800 HUMAN OTC DRUG Western Dental Sodium Fluoride PASTE DENTAL 20160211 OTC MONOGRAPH NOT FINAL part356 Yangzhou Hongshengding Chemical Co.,Ltd. SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 71038-101_612dc3bb-1258-06ad-e053-2991aa0a5ef0 71038-101 HUMAN OTC DRUG Family Care Cold and Flu Multi Symptom Relief SGC Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20171223 OTC MONOGRAPH FINAL part341 PHIL Inter Pharma Co., Ltd. ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 71039-0001_3f9465db-1beb-0517-e054-00144ff8d46c 71039-0001 HUMAN OTC DRUG CARIONE RG Zinc Pyrithione, Panthenol, Niacinamide, Biotin SHAMPOO TOPICAL 20160731 UNAPPROVED DRUG OTHER Cell Activation Research Institute Co., Ltd NIACINAMIDE; PANTHENOL; PYRITHIONE ZINC; BIOTIN .3; .5; 2.1; .06 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 71039-0002_3f9465db-1bf6-0517-e054-00144ff8d46c 71039-0002 HUMAN OTC DRUG CARIONE RG TONER Salicylic Acid LIQUID TOPICAL 20160731 OTC MONOGRAPH FINAL part358H Cell Activation Research Institute Co., Ltd MENTHOL; SALICYLIC ACID .3; .25 g/100mL; g/100mL E 20171231 71041-1601_5bc174ed-3c62-dd45-e053-2a91aa0a8846 71041-1601 HUMAN OTC DRUG Viscose Wipes Allium Cepa CLOTH TOPICAL 20161017 UNAPPROVED HOMEOPATHIC SIMPLE iDEAS, Inc. ONION 8 [hp_X]/1 N 20181231 71042-001_60c827c3-691f-d276-e053-2991aa0a11b3 71042-001 HUMAN OTC DRUG Curoxen Olive Extract, Calendula OINTMENT TOPICAL 20161021 UNAPPROVED HOMEOPATHIC OrganiCare Nature's Science, LLC OLEA EUROPAEA FRUIT VOLATILE OIL; CALENDULA OFFICINALIS FLOWERING TOP 2; 3 [hp_X]/14g; [hp_X]/14g N 20181231 71042-002_46d95e33-b3c1-3221-e054-00144ff8d46c 71042-002 HUMAN OTC DRUG Curoxen Pain Relief Olive Extract, Calendula, Arnica Montana OINTMENT TOPICAL 20170124 UNAPPROVED HOMEOPATHIC OrganiCare Nature's Science, LLC ARNICA MONTANA; OLEA EUROPAEA FRUIT VOLATILE OIL; CALENDULA OFFICINALIS FLOWERING TOP 3; 2; 3 [hp_X]/14g; [hp_X]/14g; [hp_X]/14g N 20181231 71042-003_60c87a44-2e27-5aae-e053-2991aa0a3548 71042-003 HUMAN OTC DRUG Curoxen with Vitamin D for Kids Olive Extract, Calendula, Cholecalciferol OINTMENT TOPICAL 20171220 UNAPPROVED HOMEOPATHIC OrganiCare Nature's Science, LLC CHOLECALCIFEROL; OLEA EUROPAEA FRUIT VOLATILE OIL; CALENDULA OFFICINALIS FLOWERING TOP 3; 2; 3 [hp_X]/14g; [hp_X]/14g; [hp_X]/14g N 20181231 71042-004_60cc114f-f63c-60f6-e053-2a91aa0acd53 71042-004 HUMAN OTC DRUG Curoxen Oral Care Olive Extract, Calendula, Clove Oil OINTMENT TOPICAL 20171220 UNAPPROVED HOMEOPATHIC OrganiCare Nature's Science, LLC CLOVE OIL; OLEA EUROPAEA FRUIT VOLATILE OIL; CALENDULA OFFICINALIS FLOWERING TOP 1; 2; 3 [hp_X]/12g; [hp_X]/12g; [hp_X]/12g N 20181231 71042-005_60cccf41-3524-3cfb-e053-2991aa0a1e04 71042-005 HUMAN OTC DRUG FemiClear 2 Day Olive Extract, Calendula, Melaleuca OINTMENT VAGINAL 20171220 UNAPPROVED HOMEOPATHIC OrganiCare Nature's Science, LLC MELALEUCA CAJUPUTI LEAF OIL; OLEA EUROPAEA FRUIT VOLATILE OIL; CALENDULA OFFICINALIS FLOWERING TOP 3; 2; 3 [hp_X]/28g; [hp_X]/28g; [hp_X]/28g N 20181231 71043-010_a15f1715-e109-4901-80c5-8b5189f5d17e 71043-010 HUMAN OTC DRUG O Sha mpoo Premium GLYCERIN SHAMPOO TOPICAL 20161001 UNAPPROVED DRUG OTHER Herbearth GLYCERIN 7.5 g/300g E 20171231 71044-010_b8a1af1e-1d6d-460b-90db-b897e81c7f50 71044-010 HUMAN OTC DRUG Costem cell 5 N Niacinamide SOLUTION TOPICAL 20161101 UNAPPROVED DRUG OTHER COSTEMCELL.LTD.CO NIACINAMIDE .1 g/5mL N 20181231 71046-001_403f3c70-0b06-0ca9-e054-00144ff8d46c 71046-001 HUMAN OTC DRUG ARTHO PHARMA PAIN RELIEF CAMPHOR (SYNTHETIC) GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part348 Jajy Ventures, LLC CAMPHOR (SYNTHETIC) 30 mg/mL N 20181231 71048-100_40e1d655-611d-2207-e054-00144ff88e88 71048-100 HUMAN OTC DRUG Pamela Metamorphosis Sunscreen SPF 30 OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20161109 OTC MONOGRAPH NOT FINAL part352 Pamela Metamorphisis, Inc. OCTINOXATE; ZINC OXIDE 75; 50 mg/mL; mg/mL N 20181231 71049-101_81af8abc-85c7-4977-9c19-024d608c1291 71049-101 HUMAN OTC DRUG TRIPLE ACTION ARTHRITIS METHYL SALICYLATE, MENTHOL, CAPSAICIN CREAM TOPICAL 20161022 OTC MONOGRAPH NOT FINAL part348 WONG CHARKKEN BILL METHYL SALICYLATE; MENTHOL; CAPSAICIN 28; 10; .025 g/100g; g/100g; g/100g E 20171231 71051-101_8657ca1d-09dd-4891-89ae-da053ae78210 71051-101 HUMAN OTC DRUG EBBE Colloidal Oatmeal GEL TOPICAL 20161105 OTC MONOGRAPH FINAL part347 BLUE SEA LABORATORIES SL. OATMEAL 2 g/100mL E 20171231 71055-100_66c079c4-9a7a-4309-a682-1fbda8fab658 71055-100 HUMAN OTC DRUG ICE SUN BC AIR PUFF Titanium Dioxide, OCTINOXATE, Zinc Oxide, OCTISALATE LIQUID TOPICAL 20161021 OTC MONOGRAPH NOT FINAL part352 POPCO CO.,LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.8; 1.6 g/100mL; g/100mL E 20171231 71056-100_6d3f63a4-6e04-4680-a7a1-ee02295a9b80 71056-100 HUMAN OTC DRUG bdr Re-move PH pure harmony cleanser Salicylic Acid LIQUID TOPICAL 20161024 OTC MONOGRAPH FINAL part333D Hanaim International Llc SALICYLIC ACID 2.1 g/100mL N 20181231 71056-101_ad2e61d8-e9c2-441e-86d4-abda9d42f85c 71056-101 HUMAN OTC DRUG bdr Re-action tonic professional multi active booster Niacinamide, Salicylic Acid LIQUID TOPICAL 20161026 UNAPPROVED DRUG OTHER Hanaim International Llc NIACINAMIDE; SALICYLIC ACID 1; .5 g/100mL; g/100mL N 20181231 71056-102_c7b4d1ca-a15e-4349-8b4d-ce5faa3b43f0 71056-102 HUMAN OTC DRUG bdr Re-action natural low base skin refiner exfoliation essence CITRIC ACID MONOHYDRATE LIQUID TOPICAL 20161114 UNAPPROVED DRUG OTHER Hanaim International Llc CITRIC ACID MONOHYDRATE 1.5 g/30mL N 20181231 71056-103_2f95ebed-526e-4b39-94aa-394a815abbd5 71056-103 HUMAN OTC DRUG bdr Re-action deep low base skin refiner exfoliation essence GLYCOLIC ACID LIQUID TOPICAL 20161114 UNAPPROVED DRUG OTHER Hanaim International Llc GLYCOLIC ACID 3 g/30mL N 20181231 71056-104_5104efc9-d68a-42a9-a0a8-d6c290a8a883 71056-104 HUMAN OTC DRUG bdr Re-charge contour push up serum high-potential moisturizer Panthenol, Niacinamide LIQUID TOPICAL 20161115 UNAPPROVED DRUG OTHER Hanaim International Llc PANTHENOL; NIACINAMIDE .75; .005 g/50mL; g/50mL N 20181231 71056-105_b238ca38-0efd-43a6-8f06-7597db7ab8af 71056-105 HUMAN OTC DRUG bdr Re-charge N hydro serum maximum skin energizer Panthenol LIQUID TOPICAL 20161115 UNAPPROVED DRUG OTHER Hanaim International Llc PANTHENOL .45 g/30mL N 20181231 71056-106_fec7f93f-4625-4182-aa84-87d4ca48911e 71056-106 HUMAN OTC DRUG bdr Re-lax 3 multiple level serum highly-potential youth Panthenol, Allantoin ELIXIR TOPICAL 20161116 UNAPPROVED DRUG OTHER Hanaim International Llc PANTHENOL; ALLANTOIN .33; .15 g/30mL; g/30mL N 20181231 71056-107_63fd72c5-a83f-4c85-b5b7-5606d8ce57c4 71056-107 HUMAN OTC DRUG bdr Re-set 4D age-repair code Panthenol LIQUID TOPICAL 20161116 UNAPPROVED DRUG OTHER Hanaim International Llc PANTHENOL .003 g/5mL N 20181231 71056-108_682efb79-7edc-42d2-b3ed-9ec759c0125f 71056-108 HUMAN OTC DRUG bdr Re-vital PH pure harmony care soothing skin optimizer Panthenol LIQUID TOPICAL 20161117 UNAPPROVED DRUG OTHER Hanaim International Llc PANTHENOL .375 1/50mL N 20181231 71056-109_04be4827-e47f-481e-8eba-fb7feb6295c2 71056-109 HUMAN OTC DRUG bdr Re-construct enriched nourishing formula Niacinamide CREAM TOPICAL 20161118 UNAPPROVED DRUG OTHER Hanaim International Llc NIACINAMIDE .02 g/55mL N 20181231 71056-110_ecaf5fda-ce53-40d9-945e-7516b23d49b7 71056-110 HUMAN OTC DRUG bdr Re-fine pore minimizing fluid complex Panthenol LOTION TOPICAL 20161118 UNAPPROVED DRUG OTHER Hanaim International Llc PANTHENOL .09 g/12mL N 20181231 71056-111_b923ac47-e289-414d-81a4-ae0d2513dc6d 71056-111 HUMAN OTC DRUG bdr Re-vital balance care intense age control Panthenol LOTION TOPICAL 20161118 UNAPPROVED DRUG OTHER Hanaim International Llc PANTHENOL .375 g/50mL N 20181231 71056-112_b6778fbc-bbec-4717-a247-a06f2fc8fce3 71056-112 HUMAN OTC DRUG bdr Re-fresh gel mask face Allantoin PATCH TOPICAL 20161118 UNAPPROVED DRUG OTHER Hanaim International Llc ALLANTOIN .12 g/60g N 20181231 71056-113_97ec054a-2822-4bd9-ad83-eeafa9b442b5 71056-113 HUMAN OTC DRUG bdr Bio cell mask Honey, Hyaluronic Acid PATCH TOPICAL 20161121 UNAPPROVED DRUG OTHER Hanaim International Llc HONEY; HYALURONIC ACID .56; .14 g/28g; g/28g N 20181231 71056-114_ce0a8c1e-7aac-45bc-99b3-9305d99784a5 71056-114 HUMAN OTC DRUG bdr Stretch lift mask CALENDULA OFFICINALIS WHOLE, HYALURONIC ACID PATCH TOPICAL 20161121 UNAPPROVED DRUG OTHER Hanaim International Llc CALENDULA OFFICINALIS WHOLE; HYALURONIC ACID .28; .14 g/28g; 1/28g N 20181231 71056-115_4a65f751-be04-4c02-a1b7-31ebb6918d27 71056-115 HUMAN OTC DRUG bdr Laser Effect Peptide Complex Face Mask Hyaluronic Acid, Tocopherol PATCH TOPICAL 20161122 UNAPPROVED DRUG OTHER Hanaim International Llc HYALURONIC ACID; TOCOPHEROL .51; .105 g/30g; g/30g N 20181231 71058-001_65f69424-c75d-43f7-9a55-f7fad06ecae5 71058-001 HUMAN OTC DRUG BODYWORX Adeps suillus, Adrenocorticotrophin, Agrimonia eupatoria flos, Ammonium bromatum, Anacardium orientale, Antimonium crudum, Calcarea carbonica, Coenzyme A, Cortisone aceticum, Fucus vesiculosus, Hypothalamus, Kali bichromicum, Oleander, Pituitarum posterium, RNA, Sabadilla, Staphysagria, Thyroidinum LIQUID ORAL 20161110 UNAPPROVED HOMEOPATHIC BodywoRX Medical Weight Loss Program, LLC LARD; CORTICOTROPIN; AGRIMONIA EUPATORIA FLOWER; AMMONIUM BROMIDE; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; COENZYME A; CORTISONE ACETATE; FUCUS VESICULOSUS; BOS TAURUS HYPOTHALAMUS; POTASSIUM DICHROMATE; NERIUM OLEANDER LEAF; SUS SCROFA PITUITARY GLAND; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; THYROID, UNSPECIFIED 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL; [hp_X]/118mL N 20181231 71059-010_180439d4-e607-4e41-a9d0-65d7814bb034 71059-010 HUMAN OTC DRUG Foot Clean Gold PROPOLIS WAX POWDER TOPICAL 20161101 UNAPPROVED DRUG OTHER KONEL PROPOLIS WAX 3.6 g/30g N 20181231 71060-010_e681fd4b-132a-4c15-ba06-d55a1f8dce7d 71060-010 HUMAN OTC DRUG Be Awesome Today All That 20s Brilliant Mask Dimethicone CREAM TOPICAL 20161010 OTC MONOGRAPH FINAL part347 ONA DIMETHICONE 1 g/50g N 20181231 71060-020_4c5c6bb3-489e-46ce-821f-d333cafafa8f 71060-020 HUMAN OTC DRUG Plustem UV Perfect Block Essence Octinoxate, Titanium Dioxide CREAM TOPICAL 20161010 OTC MONOGRAPH NOT FINAL part352 ONA OCTINOXATE; TITANIUM DIOXIDE 3.6; 2.2 g/50g; g/50g N 20181231 71061-763_40f8b8d1-a20c-54b0-e054-00144ff88e88 71061-763 HUMAN OTC DRUG Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20161110 OTC MONOGRAPH NOT FINAL part348 CMI Therapy Solutions MENTHOL; HISTAMINE DIHYDROCHLORIDE 30; 1 mg/mL; mg/mL N 20181231 71061-764_40f92e71-fe30-16f4-e054-00144ff8d46c 71061-764 HUMAN OTC DRUG Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20161110 OTC MONOGRAPH NOT FINAL part348 CMI Therapy Solutions MENTHOL; HISTAMINE DIHYDROCHLORIDE 30; 1 mg/mL; mg/mL N 20181231 71061-765_40f93076-1f69-58e6-e054-00144ff88e88 71061-765 HUMAN OTC DRUG Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20161110 OTC MONOGRAPH NOT FINAL part348 CMI Therapy Solutions MENTHOL; HISTAMINE DIHYDROCHLORIDE 30; 1 mg/mL; mg/mL N 20181231 71061-766_40f9622e-27c6-6a5d-e054-00144ff88e88 71061-766 HUMAN OTC DRUG Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20161110 OTC MONOGRAPH NOT FINAL part348 CMI Therapy Solutions MENTHOL; HISTAMINE DIHYDROCHLORIDE 30; 1 mg/mL; mg/mL N 20181231 71062-010_63112a0d-1368-e1b9-e053-2a91aa0a8e07 71062-010 HUMAN OTC DRUG COUGH DROP HONEY LEMON Menthol LOZENGE ORAL 20170101 OTC MONOGRAPH FINAL part341 Jahnke Süßwaren GmbH MENTHOL 7.2 mg/7.2mg N 20191231 71063-001_403dc1ab-6a4d-0e26-e054-00144ff88e88 71063-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333E Aiyaya Cloud-Commerce Tech Co., Ltd ALCOHOL 62 mL/100mL N 20181231 71063-001_40479e2f-b94f-64ca-e054-00144ff88e88 71063-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333E Aiyaya Cloud-Commerce Tech Co., Ltd ALCOHOL 62 mL/100mL N 20181231 71063-001_4047e366-943d-6d4c-e054-00144ff88e88 71063-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333E Aiyaya Cloud-Commerce Tech Co., Ltd ALCOHOL 62 mL/100mL N 20181231 71063-001_404b9b6c-5f42-4039-e054-00144ff8d46c 71063-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333E Aiyaya Cloud-Commerce Tech Co., Ltd ALCOHOL 62 mL/100mL N 20181231 71063-001_404b9b6c-5f51-4039-e054-00144ff8d46c 71063-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333E Aiyaya Cloud-Commerce Tech Co., Ltd ALCOHOL 62 mL/100mL N 20181231 71063-001_404b9b6c-5f60-4039-e054-00144ff8d46c 71063-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part333E Aiyaya Cloud-Commerce Tech Co., Ltd ALCOHOL 62 mL/100mL N 20181231 71066-0001_41280d2a-9232-5800-e054-00144ff88e88 71066-0001 HUMAN OTC DRUG PROTOXIN Clostridium botulinum Toxin Type A GEL TOPICAL 20161110 UNAPPROVED DRUG OTHER PROTOX Inc. CLOSTRIDIUM BOTULINUM 10 g/10mL E 20171231 71066-0002_4152de40-e1cc-653d-e054-00144ff88e88 71066-0002 HUMAN OTC DRUG PRO PH Filler Hyaluronic acid GEL TOPICAL 20161110 UNAPPROVED DRUG OTHER PROTOX Inc. HYALURONIC ACID 1000 g/20mL E 20171231 71067-767_41975214-a26d-41f4-e054-00144ff8d46c 71067-767 HUMAN OTC DRUG PONOS NATURAL PAIN RELIEF MENTHOL, HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20161118 OTC MONOGRAPH NOT FINAL part348 Dr. Mike's Vitamins, LLC MENTHOL; HISTAMINE DIHYDROCHLORIDE 30; .5 mg/g; mg/g N 20181231 71070-768_41975214-a27a-41f4-e054-00144ff8d46c 71070-768 HUMAN OTC DRUG JACKET SPF 50 ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE CREAM TOPICAL 20161118 OTC MONOGRAPH NOT FINAL part352 Balshi MD Dermaceuticals ZINC OXIDE; OCTINOXATE; OCTISALATE; OXYBENZONE 75; 75; 50; 50 mg/g; mg/g; mg/g; mg/g N 20181231 71074-108_2a2ab8c6-0fcc-401b-9cf9-8fca9e3899e2 71074-108 HUMAN OTC DRUG Bright Smiles Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20160515 OTC MONOGRAPH FINAL part355 Brooke Supplies SODIUM MONOFLUOROPHOSPHATE .1 g/100g N 20181231 71074-109_399ab9a0-bbcc-49be-9af8-c7e7c2b5c4f0 71074-109 HUMAN OTC DRUG Bright Smiles Sodium Fluoride GEL, DENTIFRICE DENTAL 20160515 OTC MONOGRAPH FINAL part355 Brooke Supplies SODIUM FLUORIDE .1 g/100g N 20181231 71076-0001_414f78a2-77fd-0d28-e054-00144ff88e88 71076-0001 HUMAN OTC DRUG Truezyme Baby Face and Body Glycerin LOTION TOPICAL 20161001 OTC MONOGRAPH NOT FINAL part347 Truezyme Co., Ltd. GLYCERIN .008 g/100mL E 20171231 71076-0002_41652c38-1460-062b-e054-00144ff8d46c 71076-0002 HUMAN OTC DRUG Truezyme Baby ShampooAndBody Wash Glycerin LIQUID TOPICAL 20161001 UNAPPROVED DRUG OTHER Truezyme Co., Ltd. GLYCERIN 3.5 g/100mL E 20171231 71076-0003_417468df-53be-484b-e054-00144ff88e88 71076-0003 HUMAN OTC DRUG Truezyme Water Lock Body Wash Glycerin LIQUID TOPICAL 20161001 UNAPPROVED DRUG OTHER Truezyme Co., Ltd. GLYCERIN 3.5 g/100mL E 20171231 71076-0004_4175d994-e01c-09dc-e054-00144ff88e88 71076-0004 HUMAN OTC DRUG Truezyme Active Enzyme Scalp and Hair Glycerin SHAMPOO TOPICAL 20161001 UNAPPROVED DRUG OTHER Truezyme Co., Ltd. GLYCERIN 2.5 g/100mL E 20171231 71076-0005_449e408e-6d1b-5e5b-e054-00144ff8d46c 71076-0005 HUMAN OTC DRUG Truezyme Healing Scalp Tonic Glycerin LIQUID TOPICAL 20161227 UNAPPROVED DRUG OTHER Truezyme Co., Ltd. GLYCERIN 5 g/100mL E 20171231 71076-0006_449e408e-6d36-5e5b-e054-00144ff8d46c 71076-0006 HUMAN OTC DRUG Truezyme Healing Multi Tonic Glycerin LIQUID TOPICAL 20161227 UNAPPROVED DRUG OTHER Truezyme Co., Ltd. GLYCERIN 5 g/100mL E 20171231 71077-0001_40c0958a-2bd5-5bab-e054-00144ff88e88 71077-0001 HUMAN OTC DRUG Camellia Wrinkle Free Eye NIACINAMIDE, ADENOSINE SOLUTION TOPICAL 20160928 UNAPPROVED DRUG OTHER TOV Co., ltd NIACINAMIDE; ADENOSINE 2; .04 g/100g; g/100g N 20181231 71077-0002_40c11547-930c-41fb-e054-00144ff8d46c 71077-0002 HUMAN OTC DRUG Camellia Vital Dual Serum NIACINAMIDE, ADENOSINE SOLUTION TOPICAL 20160927 UNAPPROVED DRUG OTHER TOV Co., ltd NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71077-0003_40c1dd07-5720-0597-e054-00144ff88e88 71077-0003 HUMAN OTC DRUG Camellia Cleansing Balm MINERAL SALVE TOPICAL 20161107 UNAPPROVED DRUG OTHER TOV Co., ltd MINERAL OIL 54.0999 g/100mL N 20181231 71077-0004_40c48211-6614-571c-e054-00144ff88e88 71077-0004 HUMAN OTC DRUG Lip And Hand Shea Butter NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161108 UNAPPROVED DRUG OTHER TOV Co., ltd NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71077-0005_40c48211-6616-571c-e054-00144ff88e88 71077-0005 HUMAN OTC DRUG Lip And Hand Camellia NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161108 UNAPPROVED DRUG OTHER TOV Co., ltd NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71077-0006_40c48211-662a-571c-e054-00144ff88e88 71077-0006 HUMAN OTC DRUG Lip And Hand Wild Rose NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161108 UNAPPROVED DRUG OTHER TOV Co., ltd NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71077-0007_40c2bc31-5005-093e-e054-00144ff8d46c 71077-0007 HUMAN OTC DRUG Camellia CC Cream 21 SPF45 PA TITANIUM DIOXIDE, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161108 UNAPPROVED DRUG OTHER TOV Co., ltd TITANIUM DIOXIDE; NIACINAMIDE; ADENOSINE 9.015; 2; .04 g/100g; g/100g; g/100g N 20181231 71077-0008_40c2bc31-5017-093e-e054-00144ff8d46c 71077-0008 HUMAN OTC DRUG Camellia CC Cream 22 SPF45 PA TITANIUM DIOXIDE, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161108 UNAPPROVED DRUG OTHER TOV Co., ltd TITANIUM DIOXIDE; NIACINAMIDE; ADENOSINE 9.015; 2; .04 g/100g; g/100g; g/100g N 20181231 71077-0009_40c38513-cb30-3b74-e054-00144ff88e88 71077-0009 HUMAN OTC DRUG Camellia Air Cushion 21 SPF50 PA TITANIUM DIOXIDE, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161108 UNAPPROVED DRUG OTHER TOV Co., ltd TITANIUM DIOXIDE; NIACINAMIDE; ADENOSINE 12.775; 2; .04 g/100g; g/100g; g/100g N 20181231 71077-0010_40c2bc31-5048-093e-e054-00144ff8d46c 71077-0010 HUMAN OTC DRUG Camellia Air Cushion 22 SPF50 PA TITANIUM DIOXIDE, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161108 UNAPPROVED DRUG OTHER TOV Co., ltd TITANIUM DIOXIDE; NIACINAMIDE; ADENOSINE 12.775; 2; .04 g/100g; g/100g; g/100g N 20181231 71077-0011_40c3e158-cdee-5a6b-e054-00144ff8d46c 71077-0011 HUMAN OTC DRUG Camellia Cooling CC 21 SPF50 PA TITANIUM DIOXIDE, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161108 UNAPPROVED DRUG OTHER TOV Co., ltd TITANIUM DIOXIDE; NIACINAMIDE; ADENOSINE 9.8525; 2; .04 g/100mL; g/100mL; g/100mL N 20181231 71077-0012_40c2bc31-504b-093e-e054-00144ff8d46c 71077-0012 HUMAN OTC DRUG Camellia Cooling CC 22 SPF50 PA TITANIUM DIOXIDE, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161108 UNAPPROVED DRUG OTHER TOV Co., ltd TITANIUM DIOXIDE; NIACINAMIDE; ADENOSINE 9.8525; 2; .04 g/100mL; g/100mL; g/100mL N 20181231 71078-0001_5c7f39d9-ffa7-7baa-e053-2a91aa0adae1 71078-0001 HUMAN OTC DRUG Chunzam Silk Amino Acid Tooth SILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATE, TOCOPHEROL ACETATE PASTE, DENTIFRICE DENTAL 20161111 UNAPPROVED DRUG OTHER CHUNZAM BIO CO LTD .ALPHA.-TOCOPHEROL ACETATE; SILICON DIOXIDE; SODIUM MONOFLUOROPHOSPHATE .1; 4; .33 g/100g; g/100g; g/100g N 20181231 71079-0001_418c6f7c-ec44-1c39-e054-00144ff88e88 71079-0001 HUMAN OTC DRUG APLIN SPOT ALL KILL NIACINAMIDE CREAM TOPICAL 20151001 UNAPPROVED DRUG OTHER Newizcompany NIACINAMIDE 2 g/100mL E 20171231 71079-0002_418c6f7c-ec55-1c39-e054-00144ff88e88 71079-0002 HUMAN OTC DRUG APLIN SPOT REMOVER NIACINAMIDE CREAM TOPICAL 20151001 UNAPPROVED DRUG OTHER Newizcompany NIACINAMIDE 2 g/100mL E 20171231 71080-0002_c118599c-d98e-469f-94e3-714296f04e6d 71080-0002 HUMAN OTC DRUG LeBody Fit Body Massager ILEX PARAGUARIENSIS LEAF CREAM TOPICAL 20171001 UNAPPROVED DRUG OTHER GTG Wellness Co., Ltd. ILEX PARAGUARIENSIS LEAF 3 g/150mL N 20181231 71080-0003_f7c499e8-bc46-4452-b010-b5245713ba17 71080-0003 HUMAN OTC DRUG LEBODY BU W RENEWAL UP Niacinamide, Adenosine CREAM TOPICAL 20171201 UNAPPROVED DRUG OTHER GTG Wellness Co., Ltd. NIACINAMIDE; ADENOSINE 1.6; .03 g/80mL; g/80mL N 20181231 71080-0004_841e4bbe-3add-4db5-9691-116056aae3bb 71080-0004 HUMAN OTC DRUG LEBODY FACE RENEWAL Glycerin GEL TOPICAL 20171201 UNAPPROVED DRUG OTHER GTG Wellness Co., Ltd. GLYCERIN 15 g/150mL N 20181231 71081-010_8075776d-64d4-4fd6-949f-d190e4230e15 71081-010 HUMAN OTC DRUG F X Fantacell Ampoule Witch Hazel SOLUTION TOPICAL 20161001 OTC MONOGRAPH FINAL part347 GLHKOREA WITCH HAZEL .8 mg/8mL N 20181231 71084-001_46881f19-442b-1afd-e054-00144ff8d46c 71084-001 HUMAN OTC DRUG Alkmene Anti Spot pad Green Tea LIQUID TOPICAL 20170116 UNAPPROVED DRUG OTHER Mann & Schroeder GmbH TEA TREE OIL 48 g/100g N 20181231 71085-001_60dd8389-807d-d8a9-e053-2a91aa0a0a2b 71085-001 HUMAN PRESCRIPTION DRUG Lidocaine LIDOCAINE OINTMENT TOPICAL 20161115 ANDA ANDA086724 IPG Pharmaceuticals, Inc. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 71085-002_5c5cf697-115b-4bf5-9c2c-2fbbf0c6a52e 71085-002 HUMAN PRESCRIPTION DRUG Diclofenac sodium diclofenac sodium SOLUTION TOPICAL 20141126 ANDA ANDA203818 IPG PHARMACEUTICALS, INC. DICLOFENAC SODIUM 16.05 mg/mL Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 71085-003_c4f130b9-1e58-4e59-a01d-65cd423645a3 71085-003 HUMAN PRESCRIPTION DRUG Diclofenac sodium diclofenac sodium GEL TOPICAL 20160428 ANDA ANDA206298 IPG PHARMACEUTICALS, INC. DICLOFENAC SODIUM 30 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 71085-004_4df7d200-5fec-4f32-b32c-06bded188628 71085-004 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20140714 ANDA ANDA200734 IPG PHARMACEUTICALS, INC. FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 71085-005_f4aac2fa-12c4-4711-8219-27db349a8ab2 71085-005 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 20161027 ANDA ANDA071500 IPG PHARMACEUTICALS, INC. FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 71085-006_2e9c677b-6737-4198-8b4b-94919ff8754d 71085-006 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide SOLUTION TOPICAL 19961231 ANDA ANDA074799 IPG PHARMACEUTICALS, INC. FLUOCINONIDE .5 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 71085-007_6e3c6277-56fb-479f-b5c6-58952bb5410f 71085-007 HUMAN PRESCRIPTION DRUG Clobetasol Propionate clobetasol propionate CREAM TOPICAL 19960708 ANDA ANDA074249 IPG PHARMACEUTICALS, INC. CLOBETASOL PROPIONATE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 71085-008_ea618ceb-2b37-4885-a3da-16bbf0fa429a 71085-008 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole CREAM TOPICAL 20021218 ANDA ANDA075638 IPG PHARMACEUTICALS, INC. KETOCONAZOLE 20 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 71085-009_b6eaa871-a050-4ee4-99d2-baefe246546f 71085-009 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364 IPG PHARMACEUTICALS, INC. NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 mg/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 71085-010_f7821fc7-c11b-465e-9d33-a399e09926ae 71085-010 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20170801 ANDA ANDA078722 IPG PHARMACEUTICALS, INC. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 71085-011_a2dbb08e-bfe3-4ed9-a1bc-c00a1e8912e2 71085-011 HUMAN PRESCRIPTION DRUG Lidocaine Lidocaine OINTMENT TOPICAL 19810817 ANDA ANDA086724 IPG PHARMACEUTICALS, INC. LIDOCAINE 50 mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 71086-000_41955de8-03c5-17b9-e054-00144ff88e88 71086-000 HUMAN OTC DRUG Sun Natural Sunscreen ZINC OXIDE CREAM TOPICAL 20161116 OTC MONOGRAPH NOT FINAL part352 Sun Naturals Inc ZINC OXIDE 220 mg/g E 20171231 71087-001_27b39c20-3690-4060-84db-b0682df2cfcf 71087-001 HUMAN OTC DRUG Hand Sanitizer ALCOHOL GEL TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part333A CASAD Company, Inc ALCOHOL 53.5 g/100mL N 20181231 71087-002_27b39c20-3690-4060-84db-b0682df2cfcf 71087-002 HUMAN OTC DRUG Hand Sanitizer ALCOHOL LIQUID TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part333A CASAD Company, Inc ALCOHOL 53.3 g/100mL N 20181231 71089-001_f261e8cb-b6e7-49a0-b102-54063c85b59d 71089-001 HUMAN OTC DRUG Germ Free Zone Sanitizing Wipe Alcohol CLOTH TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part333E Germ Guards Incorporated ALCOHOL .7 mL/mL N 20181231 71089-002_50e66bbc-a4b3-501d-e054-00144ff8d46c 71089-002 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20170509 OTC MONOGRAPH NOT FINAL part333E Germ Guards Incorporated ALCOHOL 62 mL/100mL N 20181231 71089-003_57718ee8-c2b8-60e0-e053-2a91aa0a8271 71089-003 HUMAN OTC DRUG Sanitizing Wipes ETHYL ALCOHOL CLOTH TOPICAL 20170823 OTC MONOGRAPH NOT FINAL part333E Germ Guards Incorporated ALCOHOL .7 mL/.7mL N 20181231 71090-001_8f5b2baf-b828-4731-a9d3-88a800649e38 71090-001 HUMAN PRESCRIPTION DRUG Keveyis Dichlorphenamide TABLET ORAL 20150807 NDA NDA011366 Strongbridge US Inc. DICHLORPHENAMIDE 50 mg/1 Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [Chemical/Ingredient] N 20181231 71093-111_4c2a81f8-c43b-44d1-ba47-ff0dc01de88b 71093-111 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN TABLET, FILM COATED ORAL 20140111 ANDA ANDA203244 ACI Healthcare USA, Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71093-112_4c2a81f8-c43b-44d1-ba47-ff0dc01de88b 71093-112 HUMAN PRESCRIPTION DRUG Gabapentin GABAPENTIN TABLET, FILM COATED ORAL 20140111 ANDA ANDA203244 ACI Healthcare USA, Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71093-132_ea2fa0a2-75bf-47f8-b0e6-5034d1af8283 71093-132 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20180115 ANDA ANDA203769 ACI Healthcare USA, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 71093-133_ea2fa0a2-75bf-47f8-b0e6-5034d1af8283 71093-133 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20180115 ANDA ANDA203769 ACI Healthcare USA, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 71093-134_ea2fa0a2-75bf-47f8-b0e6-5034d1af8283 71093-134 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET ORAL 20180115 ANDA ANDA203769 ACI Healthcare USA, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 71093-136_51dbd06c-f90e-4c7d-9335-ccdd4ee20ec8 71093-136 HUMAN PRESCRIPTION DRUG Quetiapine Extended Release Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA209635 ACI Healthcare USA, Inc. QUETIAPINE FUMARATE 150 mg/1 Atypical Antipsychotic [EPC] N 20191231 71093-137_51dbd06c-f90e-4c7d-9335-ccdd4ee20ec8 71093-137 HUMAN PRESCRIPTION DRUG Quetiapine Extended Release Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA209635 ACI Healthcare USA, Inc. QUETIAPINE FUMARATE 200 mg/1 Atypical Antipsychotic [EPC] N 20191231 71093-138_51dbd06c-f90e-4c7d-9335-ccdd4ee20ec8 71093-138 HUMAN PRESCRIPTION DRUG Quetiapine Extended Release Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA209635 ACI Healthcare USA, Inc. QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20191231 71093-139_51dbd06c-f90e-4c7d-9335-ccdd4ee20ec8 71093-139 HUMAN PRESCRIPTION DRUG Quetiapine Extended Release Quetiapine TABLET, FILM COATED, EXTENDED RELEASE ORAL 20171129 ANDA ANDA209635 ACI Healthcare USA, Inc. QUETIAPINE FUMARATE 400 mg/1 Atypical Antipsychotic [EPC] N 20191231 71094-0001_ce0797a6-6848-4329-9ced-2b24165f584a 71094-0001 HUMAN OTC DRUG Tinnistop Causticum, Cocculus Indicus, Conium Maculatum TABLET ORAL 20170117 UNAPPROVED HOMEOPATHIC Peerless Homeopathic CAUSTICUM; ANAMIRTA COCCULUS SEED; CONIUM MACULATUM FLOWERING TOP 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 71094-0002_41303cb2-51b9-4877-a1e0-a215707a7355 71094-0002 HUMAN OTC DRUG DriNites Causticum, Equisetum Hyemale, Sepia TABLET ORAL 20170913 UNAPPROVED HOMEOPATHIC Peerless Homeopathic CAUSTICUM; EQUISETUM HYEMALE; SEPIA OFFICINALIS JUICE 6; 6; 6 [hp_C]/1; [hp_C]/1; [hp_C]/1 N 20181231 71095-000_4a2984a1-4b76-4020-e054-00144ff8d46c 71095-000 HUMAN OTC DRUG Moisturizing Day with Sunscreen and Dead Sea Mineral Broad Spectrum SPF 15 OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE CREAM TOPICAL 20170307 OTC MONOGRAPH NOT FINAL part352 CrystalLine Health & Beauty from the Dead Sea LTD OCTISALATE; OXYBENZONE; OCTOCRYLENE; AVOBENZONE 50; 40; 30; 15 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71098-010_9cbc4165-acc8-46ed-8a5a-95d68b3555a2 71098-010 HUMAN OTC DRUG Applicell Advanced Dimethicone LOTION TOPICAL 20161010 OTC MONOGRAPH FINAL part347 Anc HnB Inc. DIMETHICONE 4.55 g/130mL E 20171231 71098-020_574c0d3b-10b4-4d40-83c9-df53226e0c5d 71098-020 HUMAN OTC DRUG Applicell Essential Toner Adenosine LIQUID TOPICAL 20161010 UNAPPROVED DRUG OTHER Anc HnB Inc. ADENOSINE .05 g/130mL E 20171231 71098-030_91013225-e021-4e75-91d6-de10ac897e74 71098-030 HUMAN OTC DRUG Applicell Intensive Serum Adenosine CREAM TOPICAL 20161010 UNAPPROVED DRUG OTHER Anc HnB Inc. ADENOSINE .01 g/45mL E 20171231 71098-040_5d7398a4-021a-4f32-aa29-e7713a61d037 71098-040 HUMAN OTC DRUG Applicell Miracle Adenosine CREAM TOPICAL 20161010 UNAPPROVED DRUG OTHER Anc HnB Inc. ADENOSINE .02 g/50mL E 20171231 71098-050_ae64797c-dbf0-4299-8aea-6b8810f0d217 71098-050 HUMAN OTC DRUG Applicell Perfect Eye Adenosine CREAM TOPICAL 20161010 UNAPPROVED DRUG OTHER Anc HnB Inc. ADENOSINE .01 g/30mL E 20171231 71098-060_4acc33f3-de7d-4125-a324-b978cd960d6c 71098-060 HUMAN OTC DRUG Applicell Timeless Ampoule Adenosine SOLUTION TOPICAL 20161010 UNAPPROVED DRUG OTHER Anc HnB Inc. ADENOSINE 1.2 mg/3mL E 20171231 71099-100_6b9065a5-6139-415d-962e-2a26d1b1582a 71099-100 HUMAN OTC DRUG The Barafu Intensive Serum Panthenol, Allantoin, Adenosine LIQUID TOPICAL 20161205 UNAPPROVED DRUG OTHER Bioresource Co., Ltd PANTHENOL; ALLANTOIN; ADENOSINE .15; .06; .012 g/30mL; g/30mL; g/30mL E 20171231 71100-001_b4e2c44e-3027-45d1-969c-bd3e6596fcd5 71100-001 HUMAN OTC DRUG Stout Daily SPF for Men Sunscreen LIQUID TOPICAL 20170301 OTC MONOGRAPH FINAL part352 Stout Face Care Inc. ZINC OXIDE 8.82 g/90mL N 20181231 71101-904_fc498e13-a2f4-43e0-859d-201b62697d87 71101-904 HUMAN OTC DRUG 2-Count HEAT PATCHES CAPSAICIN PATCH TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Veridian Healthcare CAPSAICIN 4 g/100g N 20181231 71101-907_09440228-2315-4dd0-ba9e-e2cddfd703a8 71101-907 HUMAN OTC DRUG Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Veridian Healthcare CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 3.1; 6; 10 g/100g; g/100g; g/100g N 20181231 71101-911_d78ab90a-30ae-459e-bd26-acd0c13018be 71101-911 HUMAN OTC DRUG THERA CARE PAIN THERAPY LIDOCAINE PATCH TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Veridian Healthcare LIDOCAINE 4 g/100g N 20181231 71102-100_571a9956-d1fa-488a-9390-dcffcc39631e 71102-100 HUMAN OTC DRUG Wizyoung Vitamin Collagen Essence Mask Pack BETAINE, SCUTELLARIA BAICALENSIS ROOT PATCH TOPICAL 20161128 UNAPPROVED DRUG OTHER WIZYOUNG CO., LTD BETAINE; SCUTELLARIA BAICALENSIS ROOT .75; .0025 g/25g; g/25g N 20181231 71102-101_0a8992e5-1994-4db0-8d80-f223aa7dc537 71102-101 HUMAN OTC DRUG Wizyoung Diamond Collagen Essence Mask Pack BETAINE, SCUTELLARIA BAICALENSIS ROOT PATCH TOPICAL 20161128 UNAPPROVED DRUG OTHER WIZYOUNG CO., LTD BETAINE; SCUTELLARIA BAICALENSIS ROOT .75; .0025 g/25g; g/25g N 20181231 71104-801_e5180433-5af4-4f9c-84fc-185b86c80422 71104-801 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Bioverativ Therapeutics Inc. N 20191231 71104-802_e5180433-5af4-4f9c-84fc-185b86c80422 71104-802 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Bioverativ Therapeutics Inc. N 20191231 71104-803_e5180433-5af4-4f9c-84fc-185b86c80422 71104-803 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Bioverativ Therapeutics Inc. N 20191231 71104-804_e5180433-5af4-4f9c-84fc-185b86c80422 71104-804 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Bioverativ Therapeutics Inc. N 20191231 71104-805_e5180433-5af4-4f9c-84fc-185b86c80422 71104-805 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Bioverativ Therapeutics Inc. N 20191231 71104-806_e5180433-5af4-4f9c-84fc-185b86c80422 71104-806 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Bioverativ Therapeutics Inc. N 20191231 71104-807_e5180433-5af4-4f9c-84fc-185b86c80422 71104-807 PLASMA DERIVATIVE ELOCTATE Antihemophilic Factor (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140714 BLA BLA125487 Bioverativ Therapeutics Inc. N 20191231 71104-911_51e15819-c046-4275-baf7-33529e6544d1 71104-911 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140505 BLA BLA125444 Bioverativ Therapeutics Inc. N 20181231 71104-922_51e15819-c046-4275-baf7-33529e6544d1 71104-922 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140505 BLA BLA125444 Bioverativ Therapeutics Inc. N 20181231 71104-933_51e15819-c046-4275-baf7-33529e6544d1 71104-933 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140505 BLA BLA125444 Bioverativ Therapeutics Inc. N 20181231 71104-944_51e15819-c046-4275-baf7-33529e6544d1 71104-944 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20140505 BLA BLA125444 Bioverativ Therapeutics Inc. N 20181231 71104-966_51e15819-c046-4275-baf7-33529e6544d1 71104-966 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20160218 BLA BLA125444 Bioverativ Therapeutics Inc. N 20181231 71104-977_51e15819-c046-4275-baf7-33529e6544d1 71104-977 PLASMA DERIVATIVE ALPROLIX Coagulation Factor IX (Recombinant), Fc Fusion Protein KIT INTRAVENOUS 20161028 BLA BLA125444 Bioverativ Therapeutics Inc. N 20181231 71105-000_5df33082-7ef2-825c-e053-2a91aa0adf57 71105-000 HUMAN OTC DRUG Redicare Emergency First Aid Eyewash Emergency First Aid Eyewash IRRIGANT IRRIGATION; OPHTHALMIC 20171110 OTC MONOGRAPH FINAL part349 Redicare LLC WATER 98.3 mL/100mL N 20181231 71105-056_41821099-f218-3204-e054-00144ff8d46c 71105-056 HUMAN OTC DRUG RediCleanse Instant Hand Sanitizer Instant Hand Sanitizer GEL TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part333A Redicare LLC ALCOHOL 62.5 mL/100mL N 20181231 71105-096_5bad29b3-7070-e787-e053-2a91aa0a8ea8 71105-096 HUMAN OTC DRUG Rediburn Burn Gel Skin Protectant Burn Gel GEL TOPICAL 20170415 OTC MONOGRAPH FINAL part346 Redicare LLC LIDOCAINE 1 g/100g N 20181231 71105-106_47e07fe1-cd83-6336-e054-00144ff88e88 71105-106 HUMAN OTC DRUG Cold and Sinus Pain Relief Cold and Sinus Pain Relief TABLET ORAL 20170201 OTC MONOGRAPH FINAL part341 Redicare LLC PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN 5; 200; 325 mg/1; mg/1; mg/1 N 20181231 71105-111_53ba9c47-5096-0e76-e054-00144ff8d46c 71105-111 HUMAN OTC DRUG Alcohol Pad Alcohol Prep Pad SWAB TOPICAL 20170331 OTC MONOGRAPH NOT FINAL part333A Redicare LLC ISOPROPYL ALCOHOL 70 g/100g N 20181231 71105-210_47e01739-bff4-51ef-e054-00144ff88e88 71105-210 HUMAN OTC DRUG Non-Aspirin Acetaminophen Non-Aspirin Acetaminophen TABLET ORAL 20170201 OTC MONOGRAPH NOT FINAL part343 Redicare LLC ACETAMINOPHEN 500 mg/1 N 20181231 71105-242_47df5786-b919-3a3e-e054-00144ff88e88 71105-242 HUMAN OTC DRUG Extra Strength Pain Reliever Extra Strength Pain Reliever TABLET ORAL 20171001 OTC MONOGRAPH NOT FINAL part343 Redicare LLC ASPIRIN; ACETAMINOPHEN; SALICYLAMIDE; CAFFEINE 162; 110; 152; 32.4 mg/1; mg/1; mg/1; mg/1 N 20181231 71105-303_47e03042-d4b3-0ae4-e054-00144ff8d46c 71105-303 HUMAN OTC DRUG Mint Flavored Antacid Mint Flavored Antacid TABLET, CHEWABLE ORAL 20170201 OTC MONOGRAPH FINAL part331 Redicare LLC CALCIUM CARBONATE 420 mg/1 N 20181231 71105-323_554d6303-a8f9-70b7-e054-00144ff8d46c 71105-323 HUMAN OTC DRUG Rediwipes Antiseptic Cleaning Towelettes BZK Antiseptic Wipes SWAB TOPICAL 20170331 OTC MONOGRAPH NOT FINAL part333A Redicare LLC BENZALKONIUM CHLORIDE .13 g/100g N 20181231 71105-333_47e0830f-31e5-5ff0-e054-00144ff88e88 71105-333 HUMAN OTC DRUG Nasal and Sinus Decongestant Nasal and Sinus Decongestant TABLET ORAL 20170201 OTC MONOGRAPH FINAL part341 Redicare LLC PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 N 20181231 71105-700_47e05711-cab2-5ee7-e054-00144ff88e88 71105-700 HUMAN OTC DRUG Cramp Tabs Cramp Tablets TABLET ORAL 20170201 OTC MONOGRAPH NOT FINAL part343 Redicare LLC PAMABROM; ACETAMINOPHEN 25; 325 mg/1; mg/1 N 20181231 71105-750_45eb33f0-71e3-11d5-e054-00144ff88e88 71105-750 HUMAN OTC DRUG Redicare Ibuprofen Ibuprofen 200mg TABLET, FILM COATED ORAL 20170201 ANDA ANDA079129 Redicare LLC IBUPROFEN 200 1/2001 N 20181231 71106-001_45ec8674-1f6e-1475-e054-00144ff8d46c 71106-001 HUMAN OTC DRUG Shopkins Bubble gum Mouth wash Sodium Fluoride LIQUID DENTAL 20170111 OTC MONOGRAPH FINAL part355 Foshan Nanhai Jiachun Biology Engineering Co., Ltd SODIUM FLUORIDE .05 mg/100g N 20181231 71106-002_45ec8db2-c37a-3d15-e054-00144ff88e88 71106-002 HUMAN OTC DRUG Shopkins Brush Buddies Sodium Fluoride PASTE DENTAL 20170111 OTC MONOGRAPH FINAL part355 Foshan Nanhai JiaChun Biology Engeneering Co., Ltd SODIUM FLUORIDE 2.4 mg/100g N 20181231 71108-001_44c0af2e-0ed1-4da3-a40c-71e5a409ad7f 71108-001 HUMAN OTC DRUG Vision Clarity Eye Drop Glycerin SOLUTION OPHTHALMIC 20170306 OTC MONOGRAPH FINAL part346 Dr Vitamins, Llc GLYCERIN 1 g/100g N 20191231 71109-010_8b8b5e64-13e6-4957-82a8-4c6954e80054 71109-010 HUMAN OTC DRUG ORIPAN GOLD SALICYLIC ACID SOAP TOPICAL 20161101 OTC MONOGRAPH FINAL part333D ORIPAN CORPORATION. KOREA SALICYLIC ACID .27 g/55g N 20181231 71109-020_6915586f-ac9e-455c-baba-dc3ef6d37900 71109-020 HUMAN OTC DRUG ORIPAN GOLD 80g SALICYLIC ACID SOAP TOPICAL 20161101 OTC MONOGRAPH FINAL part333D ORIPAN CORPORATION. KOREA SALICYLIC ACID .4 g/80g N 20181231 71109-030_266ffda8-8e4a-442f-ae4e-bc2e10e72238 71109-030 HUMAN OTC DRUG ORIPAN GOLD 100g SALICYLIC ACID SOAP TOPICAL 20161101 OTC MONOGRAPH FINAL part333D ORIPAN CORPORATION. KOREA SALICYLIC ACID .5 g/100g N 20181231 71112-101_c78209ee-748b-495f-ad83-062fa0ea877f 71112-101 HUMAN OTC DRUG WHITE IS BLACK SODIUM MONOFLUOROPHOSPHATE GEL, DENTIFRICE DENTAL 20170129 UNAPPROVED DRUG OTHER CURADEN AG SODIUM MONOFLUOROPHOSPHATE .095 mg/mg N 20181231 71112-102_689159d5-beb8-497d-8952-bdd3b68df257 71112-102 HUMAN OTC DRUG BLACK IS WHITE SODIUM MONOFLUOROPHOSPHATE GEL, DENTIFRICE DENTAL 20170129 UNAPPROVED DRUG OTHER CURADEN AG SODIUM MONOFLUOROPHOSPHATE .095 mg/mg N 20181231 71118-0001_43207277-3a18-6ba4-e054-00144ff8d46c 71118-0001 HUMAN OTC DRUG Shieldlife Collagen Ion Mask ADENOSINE PATCH TOPICAL 20160913 UNAPPROVED DRUG OTHER Orion Electronics Inc. ADENOSINE 1 g/100g E 20171231 71118-0002_4331d988-99ee-666b-e054-00144ff8d46c 71118-0002 HUMAN OTC DRUG Shieldlife Ceramide Ion Mask Glycerin PATCH TOPICAL 20160913 OTC MONOGRAPH NOT FINAL part347 Orion Electronics Inc. GLYCERIN 6 g/100g E 20171231 71118-0003_4331eaa1-ba61-2b85-e054-00144ff88e88 71118-0003 HUMAN OTC DRUG Shieldlife Whitening Ion Mask Niacinamide PATCH TOPICAL 20160913 UNAPPROVED DRUG OTHER Orion Electronics Inc. NIACINAMIDE 2.1 g/100g E 20171231 71119-0001_3b455419-4480-5e78-e054-00144ff8d46c 71119-0001 HUMAN OTC DRUG Alcohol Pad Alcohol Pad SWAB TOPICAL 20161227 OTC MONOGRAPH NOT FINAL part333A Suzhou Shunjie Sanitary Materials Co., Ltd. ISOPROPYL ALCOHOL .7 1/1 E 20171231 71120-611_93180c32-63d9-4fcb-b072-c66d96e3382b 71120-611 HUMAN OTC DRUG Durisan Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333E Sanit Technologies LLC BENZALKONIUM CHLORIDE 2.5 mg/250mL N 20191231 71120-612_48513e52-12bd-4aab-aab1-fea20e46d198 71120-612 HUMAN OTC DRUG Durisan Antimicrobial BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333E Sanit Technologies LLC BENZALKONIUM CHLORIDE 2.5 mg/250mL N 20191231 71121-010_a768c233-9ed8-4865-bd1a-7fc516f9ff5d 71121-010 HUMAN OTC DRUG DOCTORCOS Snow White Water GLOW MASK Dimethicone CREAM TOPICAL 20161101 OTC MONOGRAPH FINAL part347 DOCTORCOS CO., LTD DIMETHICONE 5.5 g/110mL N 20181231 71123-001_468c9e14-9aa9-5588-e054-00144ff88e88 71123-001 HUMAN OTC DRUG PhytoRelief CC HERBAL Menthol LOZENGE ORAL 20170104 OTC MONOGRAPH FINAL part341 Gelnova Laboratories (India) Private Limited MENTHOL 7 mg/1 N 20181231 71125-010_fe6b6c5f-0d9e-46f2-ac18-a676e2da96db 71125-010 HUMAN OTC DRUG IMU LACTOBACILLUS HELVETICUS, RICE BRAN AEROSOL, FOAM TOPICAL 20161201 UNAPPROVED DRUG OTHER RAPHAGEN CO. LTD LACTOBACILLUS HELVETICUS; RICE BRAN 1.5; 1.5 g/150mL; g/150mL N 20181231 71125-100_e64695bd-c0bc-43df-ae05-4f4dcaed16fc 71125-100 HUMAN OTC DRUG RAPHAGEN POWDE R Allantoin POWDER TOPICAL 20171001 OTC MONOGRAPH FINAL part347 RAPHAGEN CO. LTD ALLANTOIN .007 g/.7g N 20181231 71128-010_a14d30dc-38bd-465c-9c81-ffc4ab79cfb3 71128-010 HUMAN OTC DRUG CIZAR Aqua Sun Homosalate, Octocrylene, Octisalate, Avobenzone CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Kolon Wellcare Co.,Ltd. HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 4.27; 2.25; 2.02; 1.35 g/45mL; g/45mL; g/45mL; g/45mL N 20181231 71128-020_ec7b9081-06de-4e4a-bae7-5c3687efba42 71128-020 HUMAN OTC DRUG CIZAR First Calming Serum Niacinamide, Adenosine LIQUID TOPICAL 20170601 UNAPPROVED DRUG OTHER Kolon Wellcare Co.,Ltd. NIACINAMIDE; ADENOSINE .6; .012 g/30mL; g/30mL N 20181231 71128-030_1149974c-0f29-4136-a122-bfc1cbc9a845 71128-030 HUMAN OTC DRUG CIZAR First Calming Glycerin CREAM TOPICAL 20170601 UNAPPROVED DRUG OTHER Kolon Wellcare Co.,Ltd. GLYCERIN 4 g/50mL N 20181231 71128-040_6d9944f3-ba9e-4b99-b1ed-5f9d64c566be 71128-040 HUMAN OTC DRUG CIZAR First Calming Toner Glycerin LIQUID TOPICAL 20170601 UNAPPROVED DRUG OTHER Kolon Wellcare Co.,Ltd. GLYCERIN 4.8 g/120mL N 20181231 71128-050_0925b44b-0b10-43cb-8e22-d76bae1ad5c8 71128-050 HUMAN OTC DRUG WISDERMA MOST MOIST BIO AMPOULE Niacinamide, Adenosine SOLUTION TOPICAL 20170601 UNAPPROVED DRUG OTHER Kolon Wellcare Co.,Ltd. NIACINAMIDE; ADENOSINE .14; .002 g/7mL; g/7mL N 20181231 71129-772_441c3fab-5f7b-0de3-e054-00144ff88e88 71129-772 HUMAN OTC DRUG Villimed Antifungal TOLNAFTATE LIQUID TOPICAL 20161220 OTC MONOGRAPH FINAL part333C Extremity Healthcare Inc TOLNAFTATE 10 mg/mL N 20181231 71130-773_441c6b9e-db81-12f8-e054-00144ff88e88 71130-773 HUMAN OTC DRUG Miami Beach Burn Relief LIDOCAINE HYDROCHLORIDE GEL TOPICAL 20161220 OTC MONOGRAPH NOT FINAL part348 Miami Beach Brands Corporation LIDOCAINE HYDROCHLORIDE 10 mg/mL N 20181231 71130-814_4a295db5-a230-3377-e054-00144ff88e88 71130-814 HUMAN OTC DRUG Miami Beach White Gold SPF-30 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20170307 OTC MONOGRAPH NOT FINAL part352 Miami Beach Brands Corp TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71131-050_5d07f8c1-1087-4659-e053-2991aa0a399d 71131-050 HUMAN OTC DRUG Uber Numb LIDOCAINE HYDROCHLORIDE LIQUID TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part348 UBERScientific, LLC LIDOCAINE HYDROCHLORIDE 50 mg/mL N 20181231 71131-051_5d07f8c1-107b-4659-e053-2991aa0a399d 71131-051 HUMAN OTC DRUG Uber Numb LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part348 UBERScientific, LLC LIDOCAINE HYDROCHLORIDE 50 mg/g N 20181231 71131-774_441c802f-a362-1530-e054-00144ff88e88 71131-774 HUMAN OTC DRUG Uber Numb Topical Anesthetic LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20161220 OTC MONOGRAPH FINAL part346 UberScientific, LLC LIDOCAINE HYDROCHLORIDE 50 mg/g N 20181231 71131-797_4939a547-c94c-3350-e054-00144ff88e88 71131-797 HUMAN OTC DRUG Uber Numb Topical Anesthetic LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20170223 OTC MONOGRAPH FINAL part346 UberScientific, LLC LIDOCAINE HYDROCHLORIDE 50 mg/mL N 20181231 71134-010_855d195c-9ed6-4c07-a003-75edb6bcf622 71134-010 HUMAN OTC DRUG ACROPASS TROUBLE CURE HYALURONIC ACID, NIACINAMIDE PATCH TOPICAL 20161101 UNAPPROVED DRUG OTHER RAPHAS CO.,LTD HYALURONIC ACID; NIACINAMIDE .53; .03 mg/.58mg; mg/.58mg N 20181231 71135-100_4a487490-8c80-420a-a319-e91f41f1bb7d 71135-100 HUMAN OTC DRUG GIN-III Alpha and Omega GIN Sun ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20161212 OTC MONOGRAPH NOT FINAL part352 Hanwool Life Sciences. Co., Ltd ZINC OXIDE; TITANIUM DIOXIDE 2; .8 g/50mL; g/50mL N 20181231 71136-770_43b66656-f126-0288-e054-00144ff88e88 71136-770 HUMAN OTC DRUG ARTHRIT-EASE MENTHOL CREAM TOPICAL 20161215 OTC MONOGRAPH NOT FINAL part348 Atlantic Horizon International Inc. MENTHOL 50 mg/g N 20181231 71137-771_43b7a5c0-b8f9-3270-e054-00144ff88e88 71137-771 HUMAN OTC DRUG SkinTek Skin Tag Remover THUJA OCCIDENTALIS LEAFY TWIG LIQUID TOPICAL 20161215 UNAPPROVED HOMEOPATHIC Venom Advertising, LLC THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X]/15mL N 20181231 71140-0212_410ed01b-d722-097c-e054-00144ff8d46c 71140-0212 HUMAN OTC DRUG Perfectly Posh THROWING SHADE SPF30 Broad Spectrum Facial Sunscreen ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 Perfectly Posh, LLC ZINC OXIDE; TITANIUM DIOXIDE 6; 4.6 g/100g; g/100g E 20171231 71140-0332_48a1289d-a9d4-51ae-e054-00144ff8d46c 71140-0332 HUMAN OTC DRUG Perfectly Posh THROWING SHADE SPF30 Broad Spectrum Facial Sunscreen ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20170215 OTC MONOGRAPH NOT FINAL part352 Perfectly Posh, LLC ZINC OXIDE; TITANIUM DIOXIDE 6; 4.6 g/100g; g/100g N 20181231 71141-000_6e5f1aae-9905-412b-a356-69d89bbcc97f 71141-000 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET, FILM COATED ORAL 20170518 ANDA ANDA078336 Lidl US LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 71141-001_48b4c2ce-d8c8-4519-860a-dfe871fc437d 71141-001 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl TABLET, FILM COATED ORAL 20170315 ANDA ANDA075232 Lidl US LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20191231 71141-002_dc87989d-de22-485d-a569-0483137de7e2 71141-002 HUMAN OTC DRUG cough cold Dextromethorphan HBr, Guaifenesin SOLUTION ORAL 20170518 OTC MONOGRAPH FINAL part341 Lidl US LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/10mL; mg/10mL N 20181231 71141-003_93812e00-6cc0-46e6-bb7d-b5cde4ce1c72 71141-003 HUMAN OTC DRUG Allergy Relief Diphenhydramine Hydrochloride TABLET ORAL 20170320 OTC MONOGRAPH FINAL part341 Lidl US LLC DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 71141-004_075d49cf-d2bf-4e98-927c-eb4ec2a0a441 71141-004 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20170320 OTC MONOGRAPH NOT FINAL part343 Lidl US LLC ACETAMINOPHEN 500 mg/1 N 20181231 71141-005_5c9fe6ad-2379-4f61-b66b-36b2f64a9698 71141-005 HUMAN OTC DRUG Chewable Aspirin Aspirin TABLET, CHEWABLE ORAL 20170518 OTC MONOGRAPH NOT FINAL part343 Lidl US LLC ASPIRIN 81 mg/1 N 20181231 71141-006_73885649-baa0-468f-b005-47df3468d992 71141-006 HUMAN OTC DRUG Childrens Allergy Relief Diphenhydramine HCl SOLUTION ORAL 20170518 OTC MONOGRAPH FINAL part341 Lidl US LLC DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 71141-007_3568f818-3f9e-4200-a413-57acfc5e343b 71141-007 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20170315 ANDA ANDA072096 Lidl US LLC IBUPROFEN 200 mg/1 N 20181231 71141-008_aa6e701b-4c59-4d6d-855d-62265d74ba36 71141-008 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET, FILM COATED ORAL 20170320 ANDA ANDA074661 Lidl US LLC NAPROXEN SODIUM 220 mg/1 N 20181231 71141-009_6b250394-f3fb-482c-8b33-e6ec4ebc6899 71141-009 HUMAN OTC DRUG Omeprazole Omeprazole TABLET, DELAYED RELEASE ORAL 20170518 NDA NDA022032 Lidl US LLC OMEPRAZOLE 20 mg/1 N 20181231 71141-010_401e79b9-64a5-46ea-a13e-03c654ac962f 71141-010 HUMAN OTC DRUG sleep time Diphenhydramine HCl SOLUTION ORAL 20170518 OTC MONOGRAPH FINAL part338 Lidl US LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL N 20191231 71141-011_43ca74e7-7496-441b-b310-43647ba541dd 71141-011 HUMAN OTC DRUG Ibuprofen Ibuprofen SUSPENSION ORAL 20170320 ANDA ANDA074937 Lidl US LLC IBUPROFEN 100 mg/5mL N 20181231 71141-012_a6dd202a-8255-43b7-9835-e63f5ddf7cfe 71141-012 HUMAN OTC DRUG Nasal Fluticasone propionate SPRAY, METERED NASAL 20170518 ANDA ANDA207957 Lidl US LLC FLUTICASONE PROPIONATE 50 ug/1 N 20191231 71141-013_7e4cd198-88be-4176-bb28-82d6a2160edd 71141-013 HUMAN OTC DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20171002 ANDA ANDA091429 Lidl US LLC RANITIDINE HYDROCHLORIDE 150 mg/1 N 20181231 71141-020_2711836d-2fed-4f53-8672-4ea5db42b18d 71141-020 HUMAN OTC DRUG Diaper Rash Zinc oxide PASTE TOPICAL 20170605 OTC MONOGRAPH FINAL part347 Ldl US, LLC ZINC OXIDE 532 mg/g N 20181231 71141-110_4ad9398f-7489-6eaf-e054-00144ff8d46c 71141-110 HUMAN OTC DRUG Cough Drops Honey Lemon with Sugar Menthol TABLET ORAL 20170501 20180516 OTC MONOGRAPH FINAL part341 Lidl US LLC MENTHOL 7.5 mg/7.5mg N 20181231 71141-111_4ad9398f-7489-6eaf-e054-00144ff8d46c 71141-111 HUMAN OTC DRUG Cough Drops Cherry with Sugar Menthol TABLET ORAL 20170501 20180515 OTC MONOGRAPH FINAL part341 Lidl US LLC MENTHOL 5.8 mg/5.8mg N 20181231 71141-112_4ad9398f-7489-6eaf-e054-00144ff8d46c 71141-112 HUMAN OTC DRUG Cough Drops Menthol Sugar Free Menthol TABLET ORAL 20170501 20180517 OTC MONOGRAPH FINAL part341 Lidl US LLC MENTHOL 5.8 mg/5.8mg N 20181231 71141-113_8de07c4c-93b5-4fe3-919c-f9406ee1b639 71141-113 HUMAN OTC DRUG DENTALUX COMPLEX 5 SODIUM FLUORIDE PASTE DENTAL 20170308 OTC MONOGRAPH FINAL part355 LIDL US, LLC SODIUM FLUORIDE .243 g/100g N 20181231 71141-132_059bf46f-8a79-486a-995f-5f4e986ea178 71141-132 HUMAN OTC DRUG Loratadine Allergy Relief Loratadine TABLET ORAL 20170901 ANDA ANDA076134 LIDL US, LLC LORATADINE 10 mg/1 N 20191231 71141-133_4cf9e5b8-0be6-4a8b-9ee3-7e7272864279 71141-133 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20170901 ANDA ANDA077498 LIDL US, LLC CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20191231 71141-134_ca2e89be-a6a3-49d0-8016-0433ea8a3548 71141-134 HUMAN OTC DRUG Triple Antibiotic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20151215 OTC MONOGRAPH FINAL part333B Lidl US, LLC BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 71141-135_593f641c-b875-4a75-9ebe-4a6e496ced1c 71141-135 HUMAN OTC DRUG Mucus Relief Guaifenesin TABLET ORAL 20170228 OTC MONOGRAPH FINAL part341 Lidl US, LLC GUAIFENESIN 400 mg/1 N 20181231 71141-136_1c4fbeaf-0fc3-4be6-b9be-08391ed2f929 71141-136 HUMAN OTC DRUG Mucus Relief DM Guaifenesin, Dextromethorphan HBr TABLET ORAL 20170228 OTC MONOGRAPH FINAL part341 Lidl US, LLC GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 400; 20 mg/1; mg/1 N 20181231 71141-137_3b164d8b-f1bc-4036-be13-5ff8bbeff81e 71141-137 HUMAN OTC DRUG Daytime Cold and Flu Multi symptom relief Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID ORAL 20170228 OTC MONOGRAPH FINAL part341 Lidl US, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/15mL; mg/15mL; mg/15mL N 20181231 71141-138_e1ef52bd-eaf7-4d80-9944-b1035eed88ab 71141-138 HUMAN OTC DRUG Cold and Flu Nighttime Relief Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID ORAL 20170228 OTC MONOGRAPH FINAL part341 Lidl US, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL N 20181231 71141-139_634f95ef-738e-4da0-a1ee-5202bd49ce55 71141-139 HUMAN OTC DRUG Allergy Relief Fexofenadine HCl TABLET ORAL 20170228 ANDA ANDA079112 Lidl US, LLC FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 71141-140_17880d4e-ac55-40e4-abbb-5576ec736fc3 71141-140 HUMAN OTC DRUG Osmotic Laxative Polyethylene Glycol POWDER ORAL 20170331 ANDA ANDA091077 Lidl US, LLC POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 71141-149_d417cb28-c9ad-414a-ae30-6b127a923f0c 71141-149 HUMAN OTC DRUG Cold and Hot Medicated Menthol PATCH TOPICAL 20170619 OTC MONOGRAPH NOT FINAL part348 Lidl US, LLC MENTHOL, UNSPECIFIED FORM 500 mg/1 N 20181231 71141-150_573203ba-d691-485a-9be3-d797efbbe42e 71141-150 HUMAN OTC DRUG Lidl Ultra Lubricant Eye Polyethylene Glycol 400, and Propylene Glycol SOLUTION/ DROPS OPHTHALMIC 20170310 OTC MONOGRAPH FINAL part349 Lidl US, LLC POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL 4; 3 mg/mL; mg/mL N 20181231 71141-151_ab1655fa-629e-4d1c-8a1c-c6e7902e1f2a 71141-151 HUMAN OTC DRUG Lidl Redness Relief Glycerin, and Naphazoline HCI SOLUTION/ DROPS OPHTHALMIC 20170310 OTC MONOGRAPH FINAL part349 Lidl US, LLC GLYCERIN; NAPHAZOLINE HYDROCHLORIDE 2.5; 1.12 mg/mL; mg/mL N 20181231 71141-152_9d561606-23e4-459e-b9fa-1ff7758f02ad 71141-152 HUMAN OTC DRUG Oil Free Acne Wash Salicylic acid 2% LOTION TOPICAL 20170210 OTC MONOGRAPH FINAL part333D Lidl US, LLC SALICYLIC ACID 20.6 mg/mL N 20181231 71141-153_634c4933-2abc-40e6-b91e-69130ce8efef 71141-153 HUMAN OTC DRUG Hand Sanitizer Ethyl alcohol GEL TOPICAL 20170227 OTC MONOGRAPH NOT FINAL part333A Lidl US, LLC ALCOHOL 700 mg/mL N 20181231 71141-155_d242fa18-332d-4d46-9a16-24a8633b0b56 71141-155 HUMAN OTC DRUG Antiseptic Mouthrinse Eucalyptol, Menthol, Methyl salicylate, Thymol MOUTHWASH ORAL 20170209 OTC MONOGRAPH NOT FINAL part348 Lidl US, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71141-156_20846006-a45e-4a1c-a1cc-429fb14b49ca 71141-156 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20170209 OTC MONOGRAPH NOT FINAL part356 Lidl US, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71141-157_72af1759-fb24-459a-bc9e-557baa90e476 71141-157 HUMAN OTC DRUG Antiseptic Mouth Rinse Eucalyptol, Menthol, Methyl Salicylate, Thymol MOUTHWASH ORAL 20170209 OTC MONOGRAPH NOT FINAL part356 Lidl US, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71141-159_c738920d-5b9d-4d11-881a-e774489207fe 71141-159 HUMAN OTC DRUG Anticavity Fluoride Rinse Sodium Fluoride MOUTHWASH ORAL 20170209 OTC MONOGRAPH FINAL part355 Lidl US, LLC SODIUM FLUORIDE .1 mg/mL N 20181231 71141-160_11ca17e7-c092-4e07-8e8d-94ee69aa6b6e 71141-160 HUMAN OTC DRUG Tartar control plus Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20170209 OTC MONOGRAPH NOT FINAL part356 Lidl US, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71143-375_c79bbb9f-e483-4093-8c92-ea978e7bf278 71143-375 HUMAN PRESCRIPTION DRUG XHANCE fluticasone propionate SPRAY, METERED NASAL 20171003 NDA NDA209022 OptiNose US, Inc. FLUTICASONE PROPIONATE 93 ug/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 71144-0001_a98201e7-4e31-432f-92b0-327334a684e1 71144-0001 HUMAN OTC DRUG Cold and Flu Relief Baptisia Tinctoria, Calcarea Sulphurica, Allium Cepa, Calcarea Carbonica, Calcarea Phosphorica, Ferrum Phosphoricum, Kali Muriaticum, Kali Sulphuricum, Silicea, Spongia Tosta, Aconitum Napellus, Arsenicum Album, Dulcamara, Euphrasia Officinalis, Eupatorium Perfoliatum, Gelsemium Sempervirens SPRAY ORAL 20170119 UNAPPROVED HOMEOPATHIC Attuned Matrix, LLC BAPTISIA TINCTORIA ROOT; CALCIUM SULFATE ANHYDROUS; ONION; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; FERRUM PHOSPHORICUM; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SILICON DIOXIDE; SPONGIA OFFICINALIS SKELETON, ROASTED; ACONITUM NAPELLUS; ARSENIC TRIOXIDE; SOLANUM DULCAMARA TOP; EUPHRASIA STRICTA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT 3; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71146-0001_440d29b3-83a7-4337-e054-00144ff8d46c 71146-0001 HUMAN OTC DRUG Dr. Pepti CENTELLA TONER Niacinamide, Adenosine LIQUID TOPICAL 20161201 UNAPPROVED DRUG OTHER J&COCEU Co Ltd NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71146-0002_4438a2a0-ec84-5c14-e054-00144ff88e88 71146-0002 HUMAN OTC DRUG Dr. Pepti INTENSIVE Niacinamide, Adenosine CREAM TOPICAL 20161201 UNAPPROVED DRUG OTHER J&COCEU Co Ltd NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71146-0003_5761d76b-7371-59fa-e053-2a91aa0aea53 71146-0003 HUMAN OTC DRUG PEPTIDE VOLUME ESSENCE PREMIUM Niacinamide, Adenosine CREAM TOPICAL 20170823 UNAPPROVED DRUG OTHER J&COCEU Co Ltd NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71148-101_149e4f7a-c081-4cb4-a436-9e37367c885c 71148-101 HUMAN OTC DRUG VANTELIN COOL PAIN RELIEVING Gel Patch menthol, methyl salicylate PATCH TOPICAL 20170309 OTC MONOGRAPH NOT FINAL part348 Kowa Health Care America, Inc. MENTHOL; METHYL SALICYLATE 5; 10 1/1001; 1/1001 N 20181231 71148-102_f83b8a70-d452-4ce7-bb80-a3fc4e40ee8a 71148-102 HUMAN OTC DRUG VANTELIN COOL PAIN RELIEVING Gel Patch Large menthol, methyl salicylate PATCH TOPICAL 20170309 OTC MONOGRAPH NOT FINAL part348 Kowa Health Care America, Inc. MENTHOL; METHYL SALICYLATE 5; 10 1/1001; 1/1001 N 20181231 71148-103_f93134db-6646-4f11-a9f3-e9103c67e6b0 71148-103 HUMAN OTC DRUG VANTELIN HOT PAIN RELIEVING Gel Patch capsaicin, methyl salicylate PATCH TOPICAL 20170309 OTC MONOGRAPH NOT FINAL part348 Kowa Health Care America, Inc. CAPSAICIN; METHYL SALICYLATE .04; 10 1/1001; 1/1001 N 20181231 71148-104_dc35ea50-2215-4513-9c71-7b120e44f182 71148-104 HUMAN OTC DRUG VANTELIN HOT PAIN RELIEVING Gel Patch Large capsaicin, methyl salicylate PATCH TOPICAL 20170309 OTC MONOGRAPH NOT FINAL part348 Kowa Health Care America, Inc. CAPSAICIN; METHYL SALICYLATE .04; 10 1/1001; 1/1001 N 20181231 71148-105_a08ed8ac-21d3-440a-90a3-9e64813bfa52 71148-105 HUMAN OTC DRUG VANTELIN ODORLESS PAIN RELIEVING Trolamine Salicylate LIQUID TOPICAL 20170524 OTC MONOGRAPH NOT FINAL part348 Kowa Health Care America, Inc. TROLAMINE SALICYLATE 100 mg/mL N 20181231 71148-106_c810f9d7-4641-4130-831b-0b19905292e0 71148-106 HUMAN OTC DRUG VANTELIN COOL PAIN RELIEVING Camphor, Menthol, Methyl Salicylate GEL TOPICAL 20170524 OTC MONOGRAPH NOT FINAL part348 Kowa Health Care America, Inc. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 2.4; 7.2; 18 g/60g; g/60g; g/60g N 20181231 71148-107_0baee4e1-bf7d-4b5b-96f7-f7e514532eee 71148-107 HUMAN OTC DRUG VANTELIN ODORLESS PAIN RELIEVING Trolamine salicylate CREAM TOPICAL 20170524 OTC MONOGRAPH NOT FINAL part348 Kowa Health Care America, Inc. TROLAMINE SALICYLATE 10 g/100g N 20181231 71149-0001_44b29200-8561-0405-e054-00144ff8d46c 71149-0001 HUMAN OTC DRUG Mousturizing Gloves and Socks Butyrospermum Parkii(Shea Butter), Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis Leaf Extract LIQUID TOPICAL 20161201 UNAPPROVED DRUG OTHER Clean Sense JOJOBA OIL; ALOE VERA LEAF; SHEA BUTTER .01; 1; 3.5 g/100g; g/100g; g/100g E 20171231 71152-201_fdd828e3-1583-48b5-8b57-bdae587f2beb 71152-201 HUMAN PRESCRIPTION DRUG Ipratropium Bromide and Albuterol Sulfate Ipratropium Bromide and Albuterol Sulfate INHALANT RESPIRATORY (INHALATION) 20170901 ANDA ANDA076749 Medical Supply Distribution, Llc. IPRATROPIUM BROMIDE; ALBUTEROL SULFATE .5; 3 mg/3mL; mg/3mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 71153-2000_444a04b9-c143-2c14-e054-00144ff8d46c 71153-2000 HUMAN OTC DRUG gp sunscreen Avobenzone,Homosalate,Octisalate,Octocrylene LOTION TOPICAL 20161223 OTC MONOGRAPH FINAL part352 Cross-Brands Manufacturing, LLC AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 15; 5; 5 g/mL; g/mL; g/mL; g/mL E 20171231 71153-2001_444ad962-dd6d-07c8-e054-00144ff88e88 71153-2001 HUMAN OTC DRUG General Protection Avobenzone,Octisalate,Homosalate,Octocrylene,Octinoxate LOTION TOPICAL 20161223 OTC MONOGRAPH FINAL part352 Cross-Brands Manufacturing, LLC OCTISALATE; OCTOCRYLENE; OCTINOXATE; AVOBENZONE; HOMOSALATE 5; 5; 7.5; 3; 10 g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 71153-2002_444b2f9d-8635-1111-e054-00144ff88e88 71153-2002 HUMAN OTC DRUG General Protection Avobenzone,Octocrylene,Octisalate,Homosalate,Octinoxate LOTION TOPICAL 20161223 OTC MONOGRAPH FINAL part352 Cross-Brand Manufacturing, LLC OCTINOXATE; OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE 7.5; 5; 8; 15; 3 g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 71153-2004_444ad962-dd73-07c8-e054-00144ff88e88 71153-2004 HUMAN OTC DRUG General Protection Avobenzone,Octocrylene,Octisalate,Homosalate,Octinoxate LOTION TOPICAL 20161223 OTC MONOGRAPH FINAL part352 Cross-Brands Manufacturing, LLC AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 10; 7.5; 5; 5 g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 71153-2005_444c1a61-41f1-2e9e-e054-00144ff88e88 71153-2005 HUMAN OTC DRUG General Protection Avobenzone,Octisalate,Homosalate,Octocrylene,Octinoxate LOTION TOPICAL 20161223 OTC MONOGRAPH FINAL part352 Cross-Brand Manufacturing, LLC AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE; OCTINOXATE 3; 5; 10; 5; 7.5 g/mL; g/mL; g/mL; g/mL; g/mL E 20171231 71153-2006_45507079-c5a0-6a2b-e054-00144ff8d46c 71153-2006 HUMAN OTC DRUG General Protection Avobenzone,Octisalate,Homosalate AEROSOL, SPRAY TOPICAL 20170104 OTC MONOGRAPH FINAL part352 Cross-Brand Manufacturing OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE 5; 5; 3; 15 g/g; g/g; g/g; g/g N 20181231 71153-2007_45502b91-65a8-7261-e054-00144ff88e88 71153-2007 HUMAN OTC DRUG General Protection Avobenzone,Homosalate,Octisalate,Octinoxate,Octocrylene AEROSOL, SPRAY TOPICAL 20170104 OTC MONOGRAPH FINAL part352 Cross-Brands Manufacturing LLC OCTISALATE; HOMOSALATE; OCTOCRYLENE; OCTINOXATE; AVOBENZONE 5; 10; 5; 7.5; 3 g/g; g/g; g/g; g/g; g/g N 20181231 71153-2008_455004c4-9602-584d-e054-00144ff8d46c 71153-2008 HUMAN OTC DRUG General Protection Avobenzone,Octisalate,Octocrylene,Homosalate AEROSOL, SPRAY TOPICAL 20170104 OTC MONOGRAPH FINAL part352 Cross-Brands Manufacturing LLC AVOBENZONE; OCTISALATE; OCTINOXATE; OCTOCRYLENE; HOMOSALATE 3; 5; 7.5; 8; 15 g/g; g/g; g/g; g/g; g/g N 20181231 71153-2009_45513963-20e8-165d-e054-00144ff8d46c 71153-2009 HUMAN OTC DRUG General Protection Avobenzone,Homosalate,Octisalate,Octocrylene,Octinoxate AEROSOL, SPRAY TOPICAL 20170104 OTC MONOGRAPH FINAL part352 Cross-Brands Manufacturing LLC HOMOSALATE; AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OCTISALATE 10; 3; 7.5; 5; 5 g/g; g/g; g/g; g/g; g/g N 20181231 71153-2010_4550d552-0a11-4fb6-e054-00144ff8d46c 71153-2010 HUMAN OTC DRUG General Protection Avobenzone,Homosalate,Octisalate,Octocrylene,Octinoxate AEROSOL, SPRAY TOPICAL 20170104 OTC MONOGRAPH FINAL part352 Cross-Brands Manufacturing LLC HOMOSALATE; OCTINOXATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 15; 7.5; 3; 5; 8 g/g; g/g; g/g; g/g; g/g N 20181231 71153-2012_4973dd32-3c36-3a78-e054-00144ff88e88 71153-2012 HUMAN OTC DRUG General Protection Avobenzone,Octinoxate,Octisalate,Octocrylene GEL TOPICAL 20170201 OTC MONOGRAPH FINAL part352 Cross-Brands Manufacturing LLC OCTISALATE; OCTINOXATE; AVOBENZONE; OCTOCRYLENE 3; 7.5; 3; 2 g/mL; g/mL; g/mL; g/mL N 20181231 71153-2013_49738e31-67ed-0aba-e054-00144ff8d46c 71153-2013 HUMAN OTC DRUG General Protection Avobenzone,Homosalate,Octinoxate,Octisalate,Octocrylene LOTION TOPICAL 20170201 OTC MONOGRAPH FINAL part352 Cross-Brands Manufacturing LLC HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 10; 7.5; 5; 5; 3 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 71153-2014_51b42037-a0b3-5646-e054-00144ff8d46c 71153-2014 HUMAN OTC DRUG SPF 15 Avobenzone, Octisalate, Homosalate AEROSOL, SPRAY TOPICAL 20170618 OTC MONOGRAPH FINAL part352 Cross-Brands Manufacturing, LLC HOMOSALATE; AVOBENZONE; OCTISALATE 7.5; 3; 5 g/mL; g/mL; g/mL N 20181231 71154-001_44689ee0-5222-0689-e054-00144ff88e88 71154-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20161224 OTC MONOGRAPH NOT FINAL part333E Atara Holdings Inc ALCOHOL 62 mL/100mL N 20181231 71154-001_447d56ec-a776-5ae0-e054-00144ff8d46c 71154-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20161224 OTC MONOGRAPH NOT FINAL part333E Atara Holdings Inc ALCOHOL 62 mL/100mL N 20181231 71157-0017_43b92d37-1562-003b-e054-00144ff88e88 71157-0017 HUMAN OTC DRUG Achy menthol cream CREAM TOPICAL 20161219 OTC MONOGRAPH NOT FINAL part348 Kelada Creative Group LLC DBA SALVE MENTHOL 28 g/90mL N 20181231 71157-0018_5ba9ea67-9ea7-f0b7-e053-2991aa0a634b 71157-0018 HUMAN OTC DRUG Itchy Bitten Eucalyptus peppermint oil GEL TOPICAL 20170109 UNAPPROVED HOMEOPATHIC Kelada Creative Group PEPPERMINT OIL; CORYMBIA CITRIODORA LEAF OIL 3; 3 g/90mL; g/90mL N 20181231 71157-0019_616dd410-afbc-1241-e053-2a91aa0a76cd 71157-0019 HUMAN OTC DRUG Breathe Deeply menthol rub CREAM TOPICAL 20170109 OTC MONOGRAPH FINAL part341 Kelada Creative Group MENTHOL 170 g/90mL N 20181231 71157-0020_5ba9e482-8fa6-8267-e053-2a91aa0a80d3 71157-0020 HUMAN OTC DRUG Rough Dry zinc oxide, salicylic acid cream CREAM TOPICAL 20170109 OTC MONOGRAPH FINAL part347 Kelada Creative Group LLC DBA SALVE ZINC OXIDE 8 g/90mL N 20181231 71157-0021_5ba9cdb3-f4d9-7c98-e053-2a91aa0abec0 71157-0021 HUMAN OTC DRUG Scratched tea tree oil OIL TOPICAL 20170109 UNAPPROVED HOMEOPATHIC Kelada Creative Group TEA TREE OIL 1089 g/90mL N 20181231 71157-0022_5ba9e482-8f9d-8267-e053-2a91aa0a80d3 71157-0022 HUMAN OTC DRUG Perfect Skin Face Salve zinc oxide, salicylic acid cream CREAM TOPICAL 20170109 OTC MONOGRAPH FINAL part347 Kelada Creative Group ZINC OXIDE 2.4 g/.259mL N 20181231 71159-001_3fe76db1-7d41-4b6b-8c0c-dec1a127fde8 71159-001 HUMAN OTC DRUG Caftan Polygonum Foot Cream Allantoin CREAM TOPICAL 20170621 OTC MONOGRAPH FINAL part347 Moraz Medical Herbs (1989) Limited ALLANTOIN 2 g/100g N 20181231 71159-002_1834af44-cc17-4307-99d0-9a570a048f26 71159-002 HUMAN OTC DRUG Hair Zinc Pyrithione SHAMPOO TOPICAL 20170621 OTC MONOGRAPH FINAL part358H Moraz Medical Herbs (1989) Limited PYRITHIONE ZINC 2.5 g/250g N 20181231 71159-003_a2a18045-d124-48c6-b6a7-4e3bc5005e6f 71159-003 HUMAN OTC DRUG Herbaliste Zinc Pyrithione SHAMPOO TOPICAL 20170330 OTC MONOGRAPH FINAL part358H Moraz Medical Herbs (1989) Limited PYRITHIONE ZINC 5 g/500g N 20181231 71160-010_5d6e99da-4e10-25f0-e053-2a91aa0aa6f4 71160-010 HUMAN OTC DRUG SPF 30 Sunscreen with Soybean OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE SPRAY, SUSPENSION TOPICAL 20170722 OTC MONOGRAPH NOT FINAL part352 Tekweld Solutions, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 50; 20; 25 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71160-011_5d6e8fd5-4629-252c-e053-2991aa0a38cc 71160-011 HUMAN OTC DRUG SPF 30 Sunscreen OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE SPRAY, SUSPENSION TOPICAL 20170722 OTC MONOGRAPH NOT FINAL part352 Tekweld Solutions, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 50; 20; 25 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71160-012_5d6e8fd5-4639-252c-e053-2991aa0a38cc 71160-012 HUMAN OTC DRUG SPF 30 Sunscreen OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20170722 OTC MONOGRAPH NOT FINAL part352 Tekweld Solutions, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 25 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71160-013_5d6e8fd5-4649-252c-e053-2991aa0a38cc 71160-013 HUMAN OTC DRUG SPF 30 Sunscreen OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20170722 OTC MONOGRAPH NOT FINAL part352 Tekweld Solutions, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 25 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71160-014_5d6e8fd5-4659-252c-e053-2991aa0a38cc 71160-014 HUMAN OTC DRUG SPF 30 SUNSCREEN OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION TOPICAL 20170722 OTC MONOGRAPH NOT FINAL part352 Tekweld Solutions, Inc. OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 25 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71160-180_60de9fc3-fbcf-e380-e053-2a91aa0a804d 71160-180 HUMAN OTC DRUG Antibacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170109 OTC MONOGRAPH NOT FINAL part333E TEKWELD SOLUTIONS, INC. ALCOHOL 620 mg/mL N 20181231 71160-189_60de9d02-18cb-04f3-e053-2991aa0aa1a4 71160-189 HUMAN OTC DRUG Antibacterial Hand Sanitizer ALCOHOL SPRAY TOPICAL 20170109 OTC MONOGRAPH NOT FINAL part333E TEKWELD SOLUTIONS, INC. ALCOHOL 620 mg/mL N 20181231 71164-010_2bcce254-d50b-4dfa-9ec2-b8c2cdfa2fff 71164-010 HUMAN OTC DRUG MU LAB YECO SOLU TION BP Refresh EX SALICYLIC ACID SOLUTION TOPICAL 20161201 OTC MONOGRAPH FINAL part333D MU-Biz.co,.Ltd SALICYLIC ACID .1 g/25mL E 20171231 71164-020_9b76b111-58e5-439f-9a1a-a79f28b153a3 71164-020 HUMAN OTC DRUG MU LAB TURN AROUND 2W Refresh Ex NIACINAMIDE, ADENOSINE CREAM TOPICAL 20161201 UNAPPROVED DRUG OTHER MU-Biz.co,.Ltd NIACINAMIDE; ADENOSINE .4; .008 g/20mL; g/20mL E 20171231 71166-0001_020ab834-2d52-451e-98f2-30ae63160cd9 71166-0001 HUMAN OTC DRUG Pain Freedom Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii) SPRAY TOPICAL 20170228 UNAPPROVED HOMEOPATHIC Amore Energia, LLC CALENDULA OFFICINALIS FLOWERING TOP; CROTON TIGLIUM SEED; SODIUM CHLORIDE; PLANTAGO MAJOR; TOXICODENDRON PUBESCENS LEAF; SMILAX REGELII ROOT 12; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71166-0002_b336fd24-7b8a-4531-8fa1-721b79d43601 71166-0002 HUMAN OTC DRUG Pain Suppress for Women Arnica Montana, Berberis Vulgaris, Chamomilla, Hypericum Perforatum, Natrum Muriaticum, Oophorinum (Suis), Plantago Major, Rhododendron Chrysanthum, Sarsaparilla (Smilax Regelii), Sepia, Sulphur, Veratrum Album LIQUID ORAL 20180118 UNAPPROVED HOMEOPATHIC Amore Energia, LLC ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; MATRICARIA CHAMOMILLA; HYPERICUM PERFORATUM; SODIUM CHLORIDE; SUS SCROFA OVARY; PLANTAGO MAJOR; RHODODENDRON AUREUM LEAF; SMILAX ORNATA ROOT; SEPIA OFFICINALIS JUICE; SULFUR; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 71166-0003_c5e5a86d-910f-40a4-bf06-9ba91cbb1211 71166-0003 HUMAN OTC DRUG Pain Suppress for Men Arnica Montana, Berberis Vulgaris, Chamomilla, Hypericum Perforatum, Natrum Muriaticum, Nux Vomica, Orchitinum (Bovine), Plantago Major, Rhododendron Chrysanthum, Sarsaparilla (Smilax Regelii), Sulphur, Veratrum Album LIQUID ORAL 20180118 UNAPPROVED HOMEOPATHIC Amore Energia, LLC ARNICA MONTANA; BERBERIS VULGARIS ROOT BARK; MATRICARIA CHAMOMILLA; HYPERICUM PERFORATUM; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; BOS TAURUS TESTICLE; PLANTAGO MAJOR; RHODODENDRON AUREUM LEAF; SMILAX ORNATA ROOT; SULFUR; VERATRUM ALBUM ROOT 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20191231 71167-001_4605c90a-37d8-6a50-e054-00144ff8d46c 71167-001 HUMAN OTC DRUG AdoptaPlatoon SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20160710 OTC MONOGRAPH FINAL part355 HUAIAN ZONGHENG BIO-TECH CO., LTD SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 71167-002_4b50f74b-d1d5-2827-e054-00144ff8d46c 71167-002 HUMAN OTC DRUG White-Glo 2in1 with mouthwash SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20160710 OTC MONOGRAPH FINAL part355 HUAIAN ZONGHENG BIO-TECH CO., LTD SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 71167-003_4b52b9e2-17d7-71b7-e054-00144ff88e88 71167-003 HUMAN OTC DRUG White-Glo professional choice SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20160710 OTC MONOGRAPH FINAL part355 HUAIAN ZONGHENG BIO-TECH CO., LTD SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 71167-004_64384dff-e2c5-2f96-e053-2a91aa0a9a5d 71167-004 HUMAN OTC DRUG White-Glo whiting tooth SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20180202 OTC MONOGRAPH FINAL part355 HUAIAN ZONGHENG BIO-TECH CO., LTD SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20191231 71168-3040_58eec6dd-be0f-bafc-e053-2a91aa0a97cf 71168-3040 HUMAN OTC DRUG CMC ZINC OXIDE ZINC OXIDE OINTMENT TOPICAL 20170901 OTC MONOGRAPH FINAL part347 SKYLARK CMC PRIVATE LIMITED ZINC OXIDE 20 g/100g N 20181231 71168-3066_58fffc68-579f-0dfc-e053-2991aa0afb27 71168-3066 HUMAN OTC DRUG CMC SHIELD SKIN PROTECTANT ZINC OXIDE CREAM TOPICAL 20170901 OTC MONOGRAPH FINAL part347 SKYLARK CMC PRIVATE LIMITED ZINC OXIDE 3.8 g/100g N 20181231 71168-8020_58b2f3c7-a6c3-1bc4-e053-2a91aa0aba14 71168-8020 HUMAN OTC DRUG SKYLARK ZINC OXIDE OINTMENT TOPICAL 20170801 OTC MONOGRAPH FINAL part347 Skylark CMC ZINC OXIDE 3.8 g/100g N 20181231 71171-778_45c4567d-7875-6459-e054-00144ff88e88 71171-778 HUMAN OTC DRUG ELON Dual Defense Anti Fungal Formula UNDECYLENIC ACID LIQUID TOPICAL 20170102 OTC MONOGRAPH FINAL part333C Little Giant Holdings LLC UNDECYLENIC ACID 250 mg/mL N 20181231 71173-1000_464988ad-557f-13f5-e054-00144ff8d46c 71173-1000 HUMAN OTC DRUG BUDDATE INONOTUS OBLIQUUS WATER BRILLIANCE MASK Butylene Glycol, Glycerin, Inonotus Obliquus (Mushroom) Extract LIQUID TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part347 BUDDATE Co Ltd BUTYLENE GLYCOL; INONOTUS OBLIQUUS FRUITING BODY; GLYCERIN 6.03; .1; 4 g/100g; g/100g; g/100g N 20181231 71173-2000_46499995-8b14-3e5c-e054-00144ff88e88 71173-2000 HUMAN OTC DRUG BUDDATE LOTUS MOISTURE ESSENCE Glycerin, Niacinamide, Nelumbo Nucifera Flower Extract, Portulaca Oleracea Extract LIQUID TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part347 BUDDATE Co Ltd PURSLANE; NIACINAMIDE; GLYCERIN; NELUMBO NUCIFERA FLOWER .5; 2; 5.93; 1.35 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 71173-3000_46495321-fb15-3479-e054-00144ff88e88 71173-3000 HUMAN OTC DRUG BUDDATE REGES INTENSIVE TREATMENT Butylene Glycol, Hydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7 CREAM TOPICAL 20170101 UNAPPROVED DRUG OTHER BUDDATE Co Ltd PALMITOYL TETRAPEPTIDE-7; SHEA BUTTER; PALMITOYL TRIPEPTIDE-1; BUTYLENE GLYCOL; HYDROGENATED COCONUT OIL .000006; 3; .000006; 5.57; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 71174-100_9950683a-271a-4be3-b6c6-3466cebe79af 71174-100 HUMAN OTC DRUG Dr Song Acne BENZOYL PEROXIDE GEL TOPICAL 20151201 OTC MONOGRAPH FINAL part333D Secret By Nature LLC BENZOYL PEROXIDE 25 mg/g N 20181231 71174-200_9950683a-271a-4be3-b6c6-3466cebe79af 71174-200 HUMAN OTC DRUG Dr Song Acne BENZOYL PEROXIDE GEL TOPICAL 20151201 OTC MONOGRAPH FINAL part333D Secret By Nature LLC BENZOYL PEROXIDE 100 mg/g N 20181231 71175-0001_45cb4131-8464-06dc-e054-00144ff88e88 71175-0001 HUMAN OTC DRUG SCALP SCALING Biotin, Niacinamide, Panthenol, Zinc Pyrithione SHAMPOO TOPICAL 20170110 UNAPPROVED DRUG OTHER zaol BIOTIN; NIACINAMIDE; PANTHENOL; PYRITHIONE ZINC .06; .3; .5; 1.008 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 71175-0002_45cc7006-5e29-3013-e054-00144ff88e88 71175-0002 HUMAN OTC DRUG SYNERGY BOOSTER Panthenol, Salicylic Acid, Menthol LIQUID TOPICAL 20170110 UNAPPROVED DRUG OTHER zaol SALICYLIC ACID; PANTHENOL; MENTHOL .25; .2; .3 g/100mL; g/100mL; g/100mL N 20181231 71176-781_4779865e-8ccc-2d96-e054-00144ff88e88 71176-781 HUMAN OTC DRUG Capillus Hair Regrowth Treatment MINOXIDIL LIQUID TOPICAL 20170124 ANDA ANDA076239 Capillus, Llc MINOXIDIL 50 mg/mL N 20181231 71177-002_488509f7-0adc-0a75-e054-00144ff88e88 71177-002 HUMAN OTC DRUG Nutrastim Hair Regrowth Treatment For Women Minoxidil SOLUTION TOPICAL 20170214 ANDA ANDA075598 Pulsaderm Llc MINOXIDIL 20 mg/mL N 20181231 71177-005_488509f7-0ae0-0a75-e054-00144ff88e88 71177-005 HUMAN OTC DRUG Nutrastim Hair Regrowth Treatment Unscented For Men Minoxidil SOLUTION TOPICAL 20170214 ANDA ANDA075598 Pulsaderm Llc MINOXIDIL 50 mg/mL N 20181231 71178-775_45c4536a-8635-749f-e054-00144ff8d46c 71178-775 HUMAN OTC DRUG FYZICAL SPORTS Pain Relief 1-COOL MENTHOL, CAPSAICIN CREAM TOPICAL 20170103 OTC MONOGRAPH NOT FINAL part348 S.P.O.R.T.S., LLC MENTHOL; CAPSAICIN 40; .35 mg/mL; mg/mL N 20181231 71178-776_45c4567d-786b-6459-e054-00144ff88e88 71178-776 HUMAN OTC DRUG FYZICAL SPORTS Pain Relief 2 MILD CAPSAICIN CREAM TOPICAL 20170104 OTC MONOGRAPH NOT FINAL part348 Pensivy Sports Products LLC CAPSAICIN .35 mg/mL N 20181231 71178-777_45c41bbf-4681-69ee-e054-00144ff8d46c 71178-777 HUMAN OTC DRUG FYZICAL SPORTS Pain Relief CAPSAICIN CREAM TOPICAL 20170104 OTC MONOGRAPH NOT FINAL part348 S.P.O.R.T.S., LLC CAPSAICIN .75 mg/mL N 20181231 71180-001_e3307245-229e-4c41-ae79-669a1aea05f4 71180-001 HUMAN PRESCRIPTION DRUG Eskata hydrogen peroxide SOLUTION TOPICAL 20171215 NDA NDA209305 Aclaris Therapeutics, Inc. HYDROGEN PEROXIDE 40 mg/100mg N 20181231 71180-002_e3307245-229e-4c41-ae79-669a1aea05f4 71180-002 HUMAN PRESCRIPTION DRUG Eskata hydrogen peroxide SOLUTION TOPICAL 20171215 NDA NDA209305 Aclaris Therapeutics, Inc. HYDROGEN PEROXIDE 40 mg/100mg N 20181231 71181-100_af2218a1-b2ff-48b0-8b2b-8a1d002641cd 71181-100 HUMAN OTC DRUG Venodol cobra venom anagesic LOTION TOPICAL 20170630 UNAPPROVED HOMEOPATHIC Caretta Therapeutics NAJA NAJA VENOM 4 [hp_X]/mL N 20181231 71183-002_530e42a3-a5da-1c49-e054-00144ff88e88 71183-002 HUMAN OTC DRUG HOT PAIN RELIEF Capsaicin Patch PATCH TOPICAL 20170628 OTC MONOGRAPH NOT FINAL part348 Suzhou Vastech Medical Technology Co., Ltd CAPSAICIN 1.2 mg/1000mg N 20181231 71183-029_6173acd0-e5ed-79b2-e053-2a91aa0a7b46 71183-029 HUMAN OTC DRUG MEDICATED NO MESS APPLICATOR menthol LIQUID TOPICAL 20170830 OTC MONOGRAPH NOT FINAL part348 Essentials Biotech Co, Ltd MENTHOL .16 g/mL N 20181231 71183-063_6172ef17-f56e-185b-e053-2991aa0a4ba3 71183-063 HUMAN OTC DRUG Ultra Strength Pain Relief Balm camphor, menthol OINTMENT TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part348 Essentials Biotech Co, Ltd CAMPHOR (SYNTHETIC); MENTHOL .11; .11 g/g; g/g N 20181231 71183-135_6172ef17-f580-185b-e053-2991aa0a4ba3 71183-135 HUMAN OTC DRUG ULTRA STRENGTH PAIN RELIEF capsaicin LIQUID TOPICAL 20170831 OTC MONOGRAPH NOT FINAL part348 Essentials Biotech Co, Ltd. CAPSAICIN .0015 g/mL N 20181231 71183-320_4a2aff23-e5a7-668f-e054-00144ff88e88 71183-320 HUMAN OTC DRUG ULTRA STRENGTH PAIN RELIEF BALM Camphor Menthol Ointment OINTMENT TOPICAL 20170320 OTC MONOGRAPH NOT FINAL part348 Suzhou Vastech Medical Technology Co., Ltd MENTHOL; CAMPHOR (SYNTHETIC) 11; 11 g/100g; g/100g N 20181231 71186-000_19f5ac10-e623-4153-8071-dfe8ac62b3ac 71186-000 HUMAN PRESCRIPTION DRUG Vilevev MB METHENAMINE, PHENYL SALICYLATE, SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS, METHYLENE BLUE ANHYDROUS, and HYOSCYAMINE SULFATE TABLET ORAL 20110501 UNAPPROVED DRUG OTHER Vilvet Pharmaceuticals Inc METHENAMINE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; METHYLENE BLUE ANHYDROUS; HYOSCYAMINE SULFATE 81; 32.4; 40.8; 10.8; .12 mg/1; mg/1; mg/1; mg/1; mg/1 Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 71186-002_5030a8a9-40fa-4a39-87c4-5516c0afef91 71186-002 HUMAN PRESCRIPTION DRUG Vilamit MB METHENAMINE, PHENYL SALICYLATE, SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS, METHYLENE BLUE ANHYDROUS, and HYOSCYAMINE SULFATE CAPSULE ORAL 20110501 UNAPPROVED DRUG OTHER Vilvet Pharmaceuticals Inc METHENAMINE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; METHYLENE BLUE ANHYDROUS; HYOSCYAMINE SULFATE 118; 36; 40.8; 10; .12 mg/1; mg/1; mg/1; mg/1; mg/1 Oxidation-Reduction Agent [EPC],Oxidation-Reduction Activity [MoA] N 20181231 71186-003_63b3b491-6a37-4be9-983e-6533d9e60fd8 71186-003 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, FILM COATED ORAL 20110501 UNAPPROVED DRUG OTHER Vilvet Pharmaceuticals Inc PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 71186-004_63b3b491-6a37-4be9-983e-6533d9e60fd8 71186-004 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, FILM COATED ORAL 20110501 UNAPPROVED DRUG OTHER Vilvet Pharmaceuticals Inc PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 71186-007_0aad0f77-7f4a-4bc8-bcc0-0e858716fe01 71186-007 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING ORAL 20110501 UNAPPROVED DRUG OTHER Vilvet Pharmaceuticals Inc HYOSCYAMINE SULFATE .125 mg/1 N 20181231 71186-008_8227d145-bccf-404d-a844-657a8dd9f78d 71186-008 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate HYOSCYAMINE SULFATE TABLET ORAL 20110501 UNAPPROVED DRUG OTHER Vilvet Pharmaceuticals Inc HYOSCYAMINE SULFATE .125 mg/1 N 20181231 71186-009_e1849c3f-68b0-4cd0-8fa9-55311262776b 71186-009 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate HYOSCYAMINE SULFATE TABLET SUBLINGUAL 20110501 UNAPPROVED DRUG OTHER Vilvet Pharmaceuticals Inc HYOSCYAMINE SULFATE .125 mg/1 N 20181231 71190-6487_63c252ed-90b7-4fa6-9201-cb654bd55a74 71190-6487 HUMAN OTC DRUG CC Cushion Compact SunScreen - light / medium Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part352 Skin Pi LLC TITANIUM DIOXIDE; ZINC OXIDE 22.4; .5 g/100g; g/100g N 20181231 71190-7312_702cc3a0-bb4a-4afb-8c46-3fd2950af7db 71190-7312 HUMAN OTC DRUG CC Cushion Compact SunScreen - Fair / light Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part352 Skin Pi LLC TITANIUM DIOXIDE; ZINC OXIDE 22.4; .5 g/100g; g/100g N 20181231 71190-9387_da63084a-81f7-421e-a45f-61a59a586f4b 71190-9387 HUMAN OTC DRUG CC Cushion Compact SunScreen - Medium / Deep Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170118 OTC MONOGRAPH NOT FINAL part352 Skin Pi LLC TITANIUM DIOXIDE; ZINC OXIDE 22.4; .5 g/100g; g/100g N 20181231 71192-010_2b2adee9-609a-4a00-bc33-b492b42a803f 71192-010 HUMAN OTC DRUG WKND UNDERWATER SUN SCREEN 40mL OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 SURFCODE OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3; 2; 1.4 g/40mL; g/40mL; g/40mL N 20181231 71192-020_e3af7122-0cb3-4b1f-8442-77ff89291f21 71192-020 HUMAN OTC DRUG WKND UNDERWATER SUN SCREEN 80ML OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20161201 OTC MONOGRAPH NOT FINAL part352 SURFCODE OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 6; 4; 2.8 g/80mL; g/80mL; g/80mL N 20181231 71192-030_e44a0162-6102-40df-a9bf-00c738c21ba8 71192-030 HUMAN OTC DRUG WKND UNDERWATER SUN WHITE Titanium Dioxide, Octocrylene, Homosalate, Octisalate, Avobenzone STICK TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part352 SURFCODE TITANIUM DIOXIDE; OCTOCRYLENE; HOMOSALATE; OCTISALATE; AVOBENZONE 4.36; 1.8; 1.8; .9; .54 g/18g; g/18g; g/18g; g/18g; g/18g N 20191231 71192-040_7cff366d-73cd-4d9d-a60e-8640779b1a27 71192-040 HUMAN OTC DRUG WKND UNDERWATER SUN TAN Titanium Dioxide, Octocrylene, Homosalate, Octisalate, Avobenzone STICK TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part352 SURFCODE TITANIUM DIOXIDE; OCTOCRYLENE; HOMOSALATE; OCTISALATE; AVOBENZONE 2.61; 1.8; 1.8; .9; .54 g/18g; g/18g; g/18g; g/18g; g/18g N 20191231 71193-010_895c6940-e1a5-45a9-9026-7890a5d080e8 71193-010 HUMAN OTC DRUG SEEONE BODY RELAX VANILLYL BUTYL ETHER, PEPPERMINT CREAM TOPICAL 20161201 UNAPPROVED DRUG OTHER Rainbow Beauty Cosmetic VANILLYL BUTYL ETHER; PEPPERMINT OIL .48; .09 g/120mL; g/120mL N 20181231 71194-010_e89a53c8-2c3e-4d1e-ac56-822b02b0477e 71194-010 HUMAN OTC DRUG MOJELIM Dr PYRITHIONE ZINC SHAMPOO TOPICAL 20170201 OTC MONOGRAPH FINAL part358H MOJELIM COSMEDI CO., LTD PYRITHIONE ZINC 10 g/500mL N 20181231 71195-010_8dac01f0-c2de-4327-ac83-fa7d94499c12 71195-010 HUMAN OTC DRUG YENAAN JINAEK EYE Niacinamide, Adenosine CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER YENAAN COSMETICS NIACINAMIDE; ADENOSINE .6; .012 g/30g; g/30g N 20181231 71195-020_c6af0be8-e5d9-4470-89b8-2812e898f8b5 71195-020 HUMAN OTC DRUG YENAAN JINAEK Niacinamide, Adenosine CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER YENAAN COSMETICS NIACINAMIDE; ADENOSINE 1; .02 g/50g; g/50g N 20181231 71195-030_f1d9a1a5-5520-45a7-9473-efc351060309 71195-030 HUMAN OTC DRUG YENAAN JINAEK ESSENCE Niacinamide, Adenosine LIQUID TOPICAL 20170302 UNAPPROVED DRUG OTHER YENAAN COSMETICS NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 71195-040_fdbf5ccd-a9c7-429c-b2f5-174931edeac1 71195-040 HUMAN OTC DRUG YENAAN JINAEK Adenosine EMULSION TOPICAL 20170302 UNAPPROVED DRUG OTHER YENAAN COSMETICS ADENOSINE .06 g/150mL N 20181231 71195-050_e52aa9a5-52db-4c37-aaa1-3e4450b7c8b2 71195-050 HUMAN OTC DRUG YENAAN JINAEK TONER Adenosine LIQUID TOPICAL 20170302 UNAPPROVED DRUG OTHER YENAAN COSMETICS ADENOSINE .06 g/150mL N 20181231 71197-779_46761892-ada8-2370-e054-00144ff88e88 71197-779 HUMAN OTC DRUG Life Extension Shade Factor SPF30 TITANIUM DIOXIDE LOTION TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part352 Quality Supplements and Vitamins, Inc. TITANIUM DIOXIDE 60 mg/mL N 20181231 71197-780_46762967-8243-6e21-e054-00144ff8d46c 71197-780 HUMAN OTC DRUG Life Extension Shade Factor SPF30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIQUID TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part352 Quality Supplements and Vitamins, Inc. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 30; 100; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71198-001_486a175c-9f73-4f66-e054-00144ff8d46c 71198-001 HUMAN OTC DRUG Wet Wipes BENZALKONIUM CHLORIDE SWAB TOPICAL 20170213 OTC MONOGRAPH NOT FINAL part333A HANGZHOU BRIGHT DAILY CHEMICAL CO.,LTD BENZALKONIUM CHLORIDE .1 g/100g N 20181231 71200-405_586b77dc-9f7e-4424-abc5-84e05fbfbe1d 71200-405 HUMAN OTC DRUG Topical Analgesic Gel Menthol, Camphor GEL TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part348 Supadelixir Co Ltd MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL) 40; 5 mg/mL; mg/mL N 20181231 71200-605_526df5f0-6bf3-4aef-ae4e-34a82c0ca9a9 71200-605 HUMAN OTC DRUG AdipoWin Glycerin, Dimethicone CREAM TOPICAL 20170102 OTC MONOGRAPH FINAL part347 Supadelixir Co Ltd GLYCERIN; DIMETHICONE 60; 5 mg/mL; mg/mL N 20181231 71200-805_3d989726-c444-4aec-9aed-87a30be70f45 71200-805 HUMAN OTC DRUG Sunburn Soothing Glycerin, Dimethicone CREAM TOPICAL 20170102 OTC MONOGRAPH FINAL part347 Supadelixir Co Ltd GLYCERIN; DIMETHICONE 60; 5 mg/mL; mg/mL N 20181231 71203-006_2b82a096-4378-1e5a-e054-00144ff8d46c 71203-006 HUMAN OTC DRUG maxxam dermaCare Pre-Shampoo Scalp Treatment pyrithione zinc shampoo SHAMPOO TOPICAL 20180119 OTC MONOGRAPH FINAL part358H EI GLOBAL GROUP LLC PYRITHIONE ZINC 1.8 g/100mL N 20191231 71209-001_c677b35c-0432-4ee5-af57-1f95449c48b6 71209-001 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN TABLET, FILM COATED ORAL 20151229 ANDA ANDA091656 Cadila Pharmaceuticals Limited OFLOXACIN 200 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 71209-002_c677b35c-0432-4ee5-af57-1f95449c48b6 71209-002 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN TABLET, FILM COATED ORAL 20151229 ANDA ANDA091656 Cadila Pharmaceuticals Limited OFLOXACIN 300 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 71209-003_c677b35c-0432-4ee5-af57-1f95449c48b6 71209-003 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN TABLET, FILM COATED ORAL 20151229 ANDA ANDA091656 Cadila Pharmaceuticals Limited OFLOXACIN 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20181231 71209-004_dbaf4bf5-57e3-4770-a9b2-d47649e54c1b 71209-004 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20151229 ANDA ANDA201445 Cadila Pharmaceuticals Limited ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 71209-005_acef88f4-6456-4092-993f-27e1496097c7 71209-005 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20170323 ANDA ANDA202168 Cadila Pharmaceuticals Limited ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 71209-006_acef88f4-6456-4092-993f-27e1496097c7 71209-006 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20170323 ANDA ANDA202168 Cadila Pharmaceuticals Limited ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 71209-007_103c2cdd-5822-48ba-b62a-e2b11aa444ef 71209-007 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20170324 ANDA ANDA202437 Cadila Pharmaceuticals Limited FOLIC ACID 1 mg/1 N 20181231 71209-008_0b50849a-66b6-4e8f-9f45-5425a875d366 71209-008 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20160617 ANDA ANDA203266 Cadila Pharmaceuticals Limited GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 71209-012_e7e641fe-39bd-4681-a430-6dedeb6d6af5 71209-012 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20140211 ANDA ANDA203844 Cadila Pharmaceuticals Limited RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 71209-013_e7e641fe-39bd-4681-a430-6dedeb6d6af5 71209-013 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20140211 ANDA ANDA203844 Cadila Pharmaceuticals Limited RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 71209-014_e7e641fe-39bd-4681-a430-6dedeb6d6af5 71209-014 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20140211 ANDA ANDA203844 Cadila Pharmaceuticals Limited RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 71209-015_e7e641fe-39bd-4681-a430-6dedeb6d6af5 71209-015 HUMAN PRESCRIPTION DRUG Rivastigmine Tartrate Rivastigmine Tartrate CAPSULE ORAL 20140211 ANDA ANDA203844 Cadila Pharmaceuticals Limited RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 71209-016_3a7562a8-2f67-4411-ac4a-ab7924193e82 71209-016 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET ORAL 20151229 ANDA ANDA203845 Cadila Pharmaceuticals Limited HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 71209-017_3a7562a8-2f67-4411-ac4a-ab7924193e82 71209-017 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET ORAL 20151229 ANDA ANDA203845 Cadila Pharmaceuticals Limited HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 71209-018_3a7562a8-2f67-4411-ac4a-ab7924193e82 71209-018 HUMAN PRESCRIPTION DRUG HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride TABLET ORAL 20151229 ANDA ANDA203845 Cadila Pharmaceuticals Limited HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 71209-019_b4c07b57-1c0a-40a2-9353-d10296327c7d 71209-019 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET, FILM COATED ORAL 20170130 ANDA ANDA204609 Cadila Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 71209-020_b4c07b57-1c0a-40a2-9353-d10296327c7d 71209-020 HUMAN PRESCRIPTION DRUG DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET, FILM COATED ORAL 20170130 ANDA ANDA204609 Cadila Pharmaceuticals Limited DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 71209-043_46f1d57b-b0a2-4b66-953a-eca98b41499e 71209-043 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20170324 ANDA ANDA207453 Cadila Pharmaceuticals Limited ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 71209-044_46f1d57b-b0a2-4b66-953a-eca98b41499e 71209-044 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20170324 ANDA ANDA207453 Cadila Pharmaceuticals Limited ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 71209-045_46f1d57b-b0a2-4b66-953a-eca98b41499e 71209-045 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20170324 ANDA ANDA207453 Cadila Pharmaceuticals Limited ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 71209-046_46f1d57b-b0a2-4b66-953a-eca98b41499e 71209-046 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20170324 ANDA ANDA207453 Cadila Pharmaceuticals Limited ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 71209-047_43d5ff61-8788-4a90-a1ed-c562ed3051c5 71209-047 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE verapamil hydrochloride TABLET, EXTENDED RELEASE ORAL 20170527 ANDA ANDA206173 Cadila Pharmaceuticals Limited VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 71209-048_43d5ff61-8788-4a90-a1ed-c562ed3051c5 71209-048 HUMAN PRESCRIPTION DRUG VERAPAMIL HYDROCHLORIDE verapamil hydrochloride TABLET, EXTENDED RELEASE ORAL 20170527 ANDA ANDA206173 Cadila Pharmaceuticals Limited VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 71209-049_0a871ca5-ee32-4af6-90e1-5ca22a63ab93 71209-049 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20150205 ANDA ANDA208605 Cadila Pharmaceuticals Limited TELMISARTAN 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 71209-050_0a871ca5-ee32-4af6-90e1-5ca22a63ab93 71209-050 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20150205 ANDA ANDA208605 Cadila Pharmaceuticals Limited TELMISARTAN 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 71209-051_0a871ca5-ee32-4af6-90e1-5ca22a63ab93 71209-051 HUMAN PRESCRIPTION DRUG Telmisartan Telmisartan TABLET ORAL 20150205 ANDA ANDA208605 Cadila Pharmaceuticals Limited TELMISARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 71209-062_54f66845-fa5a-4976-bb94-8361e8070016 71209-062 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20171229 ANDA ANDA209794 Cadila Pharmaceuticals Limited METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 71209-063_54f66845-fa5a-4976-bb94-8361e8070016 71209-063 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20171229 ANDA ANDA209794 Cadila Pharmaceuticals Limited METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 71211-001_4787fda6-ded2-0ac1-e054-00144ff8d46c 71211-001 HUMAN OTC DRUG Natoral Korean Ginseng MENTHOL MOUTHWASH ORAL 20170129 OTC MONOGRAPH NOT FINAL part356 Natoral Limited MENTHOL, UNSPECIFIED FORM .3 mg/mL N 20181231 71212-100_4a37ef06-b73f-1ed1-e054-00144ff8d46c 71212-100 HUMAN OTC DRUG ChemStation E3 Hand Sanitizer Ethanol LIQUID TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part333E Chemstation ALCOHOL 710 g/L N 20181231 71212-101_4a39ce0a-5a27-6f30-e054-00144ff8d46c 71212-101 HUMAN OTC DRUG Chemstation HACCP Q E2 Benzalkonium Chloride LIQUID TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part333E ChemStation BENZALKONIUM CHLORIDE 1.2 g/L N 20181231 71212-102_4a3e2d2b-2cc7-7427-e054-00144ff8d46c 71212-102 HUMAN OTC DRUG Chemstation Q E2 Benzalkonium Chloride LIQUID TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part333E Chemstation BENZALKONIUM CHLORIDE 1.2 g/L N 20181231 71212-103_4a3febd5-8cf6-5306-e054-00144ff8d46c 71212-103 HUMAN OTC DRUG Chemstation E2 Chloroxylenol SOAP TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part333E Chemstation CHLOROXYLENOL 15 g/L N 20181231 71217-0001_4823c969-a4e3-585f-e054-00144ff88e88 71217-0001 HUMAN OTC DRUG HYDRA BALANCING ROSE MIST Glycerin LIQUID TOPICAL 20170208 OTC MONOGRAPH NOT FINAL part347 In This Morning GLYCERIN 2.00008 g/100mL N 20181231 71217-0002_4825fb90-c441-573a-e054-00144ff8d46c 71217-0002 HUMAN OTC DRUG HYDRA BALANCING ROSE MIST Glycerin LIQUID TOPICAL 20170208 OTC MONOGRAPH NOT FINAL part347 In This Morning GLYCERIN 2.00008 g/100mL N 20181231 71217-0003_48268e37-5cf5-0c48-e054-00144ff8d46c 71217-0003 HUMAN OTC DRUG HYDRA TREATMENT TONER Glycerin LIQUID TOPICAL 20170208 OTC MONOGRAPH NOT FINAL part347 In This Morning GLYCERIN 5.740794 g/100mL N 20181231 71217-0004_48ffdad3-1e90-6480-e054-00144ff88e88 71217-0004 HUMAN OTC DRUG Hydra Extra ConcentrateSerum NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170208 UNAPPROVED DRUG OTHER In This Morning ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71217-0005_4901479e-7519-743d-e054-00144ff8d46c 71217-0005 HUMAN OTC DRUG HYDRA MOISTURE DAY AND NIGHT NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170208 UNAPPROVED DRUG OTHER In This Morning ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71217-0006_48ffdad3-1e95-6480-e054-00144ff88e88 71217-0006 HUMAN OTC DRUG HYDRA LUXURIOUS ROSE Glycerin OIL TOPICAL 20170208 UNAPPROVED DRUG OTHER In This Morning JOJOBA OIL 10 g/100mL N 20181231 71217-0007_4901479e-753d-743d-e054-00144ff8d46c 71217-0007 HUMAN OTC DRUG Whitening ConcentrateTreatment Mask NIACINAMIDE LIQUID TOPICAL 20170208 UNAPPROVED DRUG OTHER In This Morning NIACINAMIDE 3 g/100mL N 20181231 71217-0008_4901b6a2-a8e4-24a8-e054-00144ff8d46c 71217-0008 HUMAN OTC DRUG PURIFYING SKIN BALANCING ADENOSINE CREAM TOPICAL 20170208 UNAPPROVED DRUG OTHER In This Morning ADENOSINE .04 g/100mL N 20181231 71217-0009_489d4f5d-aca2-5df8-e054-00144ff88e88 71217-0009 HUMAN OTC DRUG IDEAL TONE UP GLOW BB Titanium Dioxide, Zinc Oxide, Niacinamide, Adenosine CREAM TOPICAL 20170216 UNAPPROVED DRUG OTHER In This Morning NIACINAMIDE; TITANIUM DIOXIDE; ZINC OXIDE; ADENOSINE 2; 9.692336; 2.939265; .04 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 71217-0010_4862d7ad-7b42-20ce-e054-00144ff8d46c 71217-0010 HUMAN OTC DRUG PROTECTIVE BASE SUN FOR DRY SKIN ZINC OXIDE, TITANIUM DIOXIDE, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170208 UNAPPROVED DRUG OTHER In This Morning NIACINAMIDE; ZINC OXIDE; TITANIUM DIOXIDE; ADENOSINE 2; 4.9; 2.905; .04 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 71217-0011_4824ddee-3b33-26b4-e054-00144ff8d46c 71217-0011 HUMAN OTC DRUG PROTECTIVE BASE SUN FOR OILY SKIN ZINC OXIDE, TITANIUM DIOXIDE, NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170208 UNAPPROVED DRUG OTHER In This Morning NIACINAMIDE; ZINC OXIDE; TITANIUM DIOXIDE; ADENOSINE 2; 4.32; 3.24; .04 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 71217-0012_48753081-9a38-22a5-e054-00144ff8d46c 71217-0012 HUMAN OTC DRUG MOMMY TO BE TUMMY Glycerin CREAM TOPICAL 20170208 OTC MONOGRAPH NOT FINAL part347 In This Morning GLYCERIN 2.005 g/100mL N 20181231 71217-0013_4876ef4b-9922-0e0f-e054-00144ff8d46c 71217-0013 HUMAN OTC DRUG MOMMY TO BE LUXURIOUS FIRMING BODY Citrus Aurantium Bergamia Fruit Oil OIL TOPICAL 20170208 UNAPPROVED DRUG OTHER In This Morning BERGAMOT OIL .0606 g/100mL N 20181231 71217-0014_489da72e-df06-0d17-e054-00144ff8d46c 71217-0014 HUMAN OTC DRUG LUCID COLOR LIP LOCQUER SCARLET RED Dimethicone LIPSTICK TOPICAL 20170216 UNAPPROVED DRUG OTHER In This Morning DIMETHICONE 6 g/100g N 20181231 71217-0015_489e03d9-5363-1dd5-e054-00144ff8d46c 71217-0015 HUMAN OTC DRUG LUCID COLOR LIP LOCQUER NEOCLASSIC NUDE Dimethicone LIPSTICK TOPICAL 20170216 UNAPPROVED DRUG OTHER In This Morning DIMETHICONE 6 g/100g N 20181231 71217-0017_52c0a5be-e1d1-3f98-e054-00144ff8d46c 71217-0017 HUMAN OTC DRUG MAY MORNING CUSHION 21 dimethicone CREAM TOPICAL 20170624 UNAPPROVED DRUG OTHER In This Morning DIMETHICONE .1 g/100g N 20181231 71217-0018_52c0a506-1133-264a-e054-00144ff88e88 71217-0018 HUMAN OTC DRUG MAY MORNING CUSHION 21 dimethicone CREAM TOPICAL 20170624 UNAPPROVED DRUG OTHER In This Morning DIMETHICONE .1 g/100g N 20181231 71219-782_4897eb9a-ce4c-1f80-e054-00144ff88e88 71219-782 HUMAN OTC DRUG Rejuvaflex Natural Pain Relieving MENTHOL, CAMPHOR GEL TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part348 KT Marketing Group Inc. MENTHOL; CAMPHOR (NATURAL) 100; 30 mg/mL; mg/mL N 20181231 71220-001_986270f0-9ebb-4e8a-b4de-879e3dcb5cc4 71220-001 HUMAN OTC DRUG blemish care with bija seed oil Salicylic Acid LOTION TOPICAL 20170303 OTC MONOGRAPH FINAL part333D Innisfree SALICYLIC ACID 2 g/40mL N 20181231 71220-002_c9d5733b-a131-44f3-873b-131f3b4bc6fa 71220-002 HUMAN OTC DRUG blemish care mask with bija seed Salicylic Acid LOTION TOPICAL 20170303 OTC MONOGRAPH FINAL part333D Innisfree SALICYLIC ACID 2 g/120mL N 20181231 71220-003_0cba66c2-fd77-4049-a805-85ac99581f30 71220-003 HUMAN OTC DRUG blemish care spot serum with bija seed oil Salicylic Acid LOTION TOPICAL 20170513 OTC MONOGRAPH FINAL part333D Innisfree Corporation SALICYLIC ACID 1.5 g/15mL N 20181231 71220-004_5642d790-d586-457e-b4f5-024d583bd645 71220-004 HUMAN OTC DRUG blemish care toner with bija seed Salicylic Acid LOTION TOPICAL 20170513 OTC MONOGRAPH FINAL part333D Innisfree Corporation SALICYLIC ACID .6 g/200mL N 20181231 71220-005_b95d2c20-23ec-4ed4-ba7c-a247ccd5e146 71220-005 HUMAN OTC DRUG blemish care with bija seed Salicylic Acid LOTION TOPICAL 20170513 OTC MONOGRAPH FINAL part333D Innisfree Corporation SALICYLIC ACID .6 g/100mL N 20181231 71220-007_dc1fa12c-6dfc-4f65-805c-f15942395da3 71220-007 HUMAN OTC DRUG balancing emulsion with green tea AVOBENZONE, HOMOSALATE, and OCTOCRYLENE LOTION TOPICAL 20170513 OTC MONOGRAPH FINAL part352 Innisfree Corporation AVOBENZONE; HOMOSALATE; OCTOCRYLENE 2.5; 3; 8 g/100mL; g/100mL; g/100mL N 20181231 71220-008_f4be261e-7b54-441b-ac0e-1739cd9803a2 71220-008 HUMAN OTC DRUG youth-enriched with orchid Avobenzone, Homosalate, and Octocrylene LOTION TOPICAL 20170513 OTC MONOGRAPH FINAL part352 Innisfree Corporation AVOBENZONE; HOMOSALATE; OCTOCRYLENE 2.5; 3; 8 g/100mL; g/100mL; g/100mL N 20181231 71220-009_8cdb796b-18b4-486f-bc00-9f97edbdb4c7 71220-009 HUMAN OTC DRUG daily UV protection cream mild AVOBENZONE, Homosalate, and OCTISALATE LOTION TOPICAL 20170513 OTC MONOGRAPH FINAL part352 Innisfree Corporation AVOBENZONE; HOMOSALATE; OCTISALATE 2.5; 7; 4.3 g/50mL; g/50mL; g/50mL N 20181231 71220-010_b5b23d63-8523-4f0a-a29c-edb577b571a2 71220-010 HUMAN OTC DRUG daily UV protection cream sebum care ZINC OXIDE and TITANIUM DIOXIDE LOTION TOPICAL 20170513 OTC MONOGRAPH FINAL part352 Innisfree Corporation ZINC OXIDE; TITANIUM DIOXIDE 11.0116; 6.0009 g/50mL; g/50mL N 20181231 71220-011_9333ab7a-6079-42ac-8ec2-b364431d1d5f 71220-011 HUMAN OTC DRUG intense UV protection cream ZINC OXIDE, OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE LOTION TOPICAL 20170513 OTC MONOGRAPH FINAL part352 Innisfree Corporation ZINC OXIDE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 12.6616; 6.8; 4.5; 4.0006 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 71220-012_f10a7b3d-7c11-4a3f-9ed5-87c1f3156391 71220-012 HUMAN OTC DRUG intense UV protection emulsion HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE LOTION TOPICAL 20171201 OTC MONOGRAPH FINAL part352 Innisfree Corporation HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 4.5; 3.4; 2.5; 2.25; 1.45 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL N 20181231 71220-013_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-013 HUMAN OTC DRUG fine finish pressed powder C13 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-014_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-014 HUMAN OTC DRUG fine finish pressed powder C21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-015_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-015 HUMAN OTC DRUG fine finish pressed powder N21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-016_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-016 HUMAN OTC DRUG fine finish pressed powder W21 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-017_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-017 HUMAN OTC DRUG fine finish pressed powder N23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-018_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-018 HUMAN OTC DRUG fine finish pressed powder W23 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-019_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-019 HUMAN OTC DRUG fine finish pressed powder C27 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-020_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-020 HUMAN OTC DRUG fine finish pressed powder N27 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-021_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-021 HUMAN OTC DRUG fine finish pressed powder N31 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-022_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-022 HUMAN OTC DRUG fine finish pressed powder W31 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-023_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-023 HUMAN OTC DRUG fine finish pressed powder N33 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-024_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-024 HUMAN OTC DRUG fine finish pressed powder W35 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-025_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-025 HUMAN OTC DRUG fine finish pressed powder W37 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-026_b8f6c2b5-68b3-442b-b3d3-bd8d99a88252 71220-026 HUMAN OTC DRUG fine finish pressed powder C43 OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION TOPICAL 20170623 OTC MONOGRAPH FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.19776; 4.268; 1.96 g/13g; g/13g; g/13g N 20181231 71220-027_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-027 HUMAN OTC DRUG aqua fit cushion C11 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-028_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-028 HUMAN OTC DRUG aqua fit cushion C13 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-029_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-029 HUMAN OTC DRUG aqua fit cushion C21 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-030_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-030 HUMAN OTC DRUG aqua fit cushion N21 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-031_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-031 HUMAN OTC DRUG aqua fit cushion W21 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-032_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-032 HUMAN OTC DRUG aqua fit cushion N23 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-033_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-033 HUMAN OTC DRUG aqua fit cushion W23 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-034_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-034 HUMAN OTC DRUG aqua fit cushion N27 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-035_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-035 HUMAN OTC DRUG aqua fit cushion N31 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-036_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-036 HUMAN OTC DRUG aqua fit cushion W33 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-037_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-037 HUMAN OTC DRUG aqua fit cushion W34 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-038_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-038 HUMAN OTC DRUG aqua fit cushion W35 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-039_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-039 HUMAN OTC DRUG aqua fit cushion W37 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-040_8dc502ac-6ef9-4e4f-a8c5-6978e4f8a67b 71220-040 HUMAN OTC DRUG aqua fit cushion C43 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 1.66; 1.96 g/14g; g/14g; g/14g N 20181231 71220-041_1f9a6537-45f9-4918-b037-f44c9c0a9565 71220-041 HUMAN OTC DRUG matte full cover cushion C11 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC 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71220-048_1f9a6537-45f9-4918-b037-f44c9c0a9565 71220-048 HUMAN OTC DRUG matte full cover cushion N27 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.32; 7.84 g/14g; g/14g; g/14g N 20181231 71220-049_1f9a6537-45f9-4918-b037-f44c9c0a9565 71220-049 HUMAN OTC DRUG matte full cover cushion N31 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.32; 7.84 g/14g; g/14g; g/14g N 20181231 71220-050_1f9a6537-45f9-4918-b037-f44c9c0a9565 71220-050 HUMAN OTC DRUG matte full cover cushion W33 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.32; 7.84 g/14g; g/14g; g/14g N 20181231 71220-051_1f9a6537-45f9-4918-b037-f44c9c0a9565 71220-051 HUMAN OTC DRUG matte full cover cushion W34 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.32; 7.84 g/14g; g/14g; g/14g N 20181231 71220-052_1f9a6537-45f9-4918-b037-f44c9c0a9565 71220-052 HUMAN OTC DRUG matte full cover cushion W35 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.32; 7.84 g/14g; g/14g; g/14g N 20181231 71220-053_1f9a6537-45f9-4918-b037-f44c9c0a9565 71220-053 HUMAN OTC DRUG matte full cover cushion W37 OCTINOXATE, Titanium Dioxide, and Zinc Oxide LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7; 3.32; 7.84 g/14g; g/14g; g/14g N 20181231 71220-054_1f9a6537-45f9-4918-b037-f44c9c0a9565 71220-054 HUMAN OTC DRUG matte full cover cushion C43 OCTINOXATE, Titanium Dioxide, and 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FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-059_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-059 HUMAN OTC DRUG matte full cover foundation W21 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-060_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-060 HUMAN OTC DRUG matte full cover foundation N23 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-061_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-061 HUMAN OTC DRUG matte full cover foundation W23 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-062_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-062 HUMAN OTC DRUG matte full cover foundation C27 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-063_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-063 HUMAN OTC DRUG matte full cover foundation N27 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-064_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-064 HUMAN OTC DRUG matte full cover foundation W27 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-065_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-065 HUMAN OTC DRUG matte full cover foundation C31 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-066_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-066 HUMAN OTC DRUG matte full cover foundation N31 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-067_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-067 HUMAN OTC DRUG matte full cover foundation W31 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-068_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-068 HUMAN OTC DRUG matte full cover foundation N33 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-069_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-069 HUMAN OTC DRUG matte full cover foundation W33 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-070_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-070 HUMAN OTC DRUG matte full cover foundation C35 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-071_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-071 HUMAN OTC DRUG matte full cover foundation N35 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-072_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-072 HUMAN OTC DRUG matte full cover foundation W35 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-073_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-073 HUMAN OTC DRUG matte full cover foundation W37 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-074_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-074 HUMAN OTC DRUG matte full cover foundation N41 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71220-075_d19ff006-5088-4307-b4fd-23b19ffd0374 71220-075 HUMAN OTC DRUG matte full cover foundation C43 OCTINOXATE LOTION TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part352 Innisfree Corporation OCTINOXATE 3 g/30g N 20181231 71221-783_477b067c-e486-4110-e054-00144ff8d46c 71221-783 HUMAN OTC DRUG Coral Safe Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170102 OTC MONOGRAPH NOT FINAL part352 Elements Brands Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71221-790_4925a3ad-6370-108a-e054-00144ff8d46c 71221-790 HUMAN OTC DRUG Coral Safe SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170221 OTC MONOGRAPH NOT FINAL part352 Elements Brands, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71221-791_4925a507-8642-1088-e054-00144ff8d46c 71221-791 HUMAN OTC DRUG Coral Safe SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170221 OTC MONOGRAPH NOT FINAL part352 Elements Brands, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71221-792_4925a3ad-637d-108a-e054-00144ff8d46c 71221-792 HUMAN OTC DRUG Coral Safe SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170221 OTC MONOGRAPH NOT FINAL part352 Elements Brands, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71221-793_4935c617-579e-2f3d-e054-00144ff88e88 71221-793 HUMAN OTC DRUG Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut) TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170222 OTC MONOGRAPH NOT FINAL part352 Elements Brands, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71221-794_493551d0-10a4-3d78-e054-00144ff8d46c 71221-794 HUMAN OTC DRUG Tropical Sands, SPF-50 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170222 OTC MONOGRAPH NOT FINAL part352 Elements Brands, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71221-795_49363fb7-b406-5f1d-e054-00144ff8d46c 71221-795 HUMAN OTC DRUG Tropical Sands SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170221 OTC MONOGRAPH NOT FINAL part352 Elements Brands, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71221-796_494a7886-d679-1648-e054-00144ff8d46c 71221-796 HUMAN OTC DRUG Tropical Sands SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170224 OTC MONOGRAPH NOT FINAL part352 Elements Brands, Inc. TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71222-001_48f6f612-65eb-35d3-e054-00144ff88e88 71222-001 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20130520 OTC MONOGRAPH NOT FINAL part333A Tongzhou Deqi Medical Products Factory ISOPROPYL ALCOHOL .7 mL/1 N 20181231 71222-002_4902601f-da31-3849-e054-00144ff8d46c 71222-002 HUMAN OTC DRUG STING RELIEF MEDICATED PAD Benzocaine SWAB TOPICAL 20130520 OTC MONOGRAPH FINAL part333B Tongzhou Deqi Medical Products Factory BENZOCAINE .06 mg/1 N 20181231 71222-003_495242cd-f098-0792-e054-00144ff8d46c 71222-003 HUMAN OTC DRUG Povidone-Iodine Prep Pad Povidone-Iodine SWAB PERCUTANEOUS 20130520 OTC MONOGRAPH FINAL part333C Tongzhou Deqi Medical Products Factory POVIDONE-IODINE 10 mg/1 N 20181231 71222-004_4855806d-695a-72ee-e054-00144ff8d46c 71222-004 HUMAN OTC DRUG Benzalkonium Chloride Antiseptic benzalkonium chloride SWAB TOPICAL 20170120 OTC MONOGRAPH NOT FINAL part333A Tongzhou Deqi Medical Products Factory BENZALKONIUM CHLORIDE .0013 mg/1 N 20181231 71222-005_49525f5d-9fd7-0c61-e054-00144ff8d46c 71222-005 HUMAN OTC DRUG Cleansing Towelette benzalkonium chloride SWAB TOPICAL 20140411 OTC MONOGRAPH NOT FINAL part333A Tongzhou Deqi Medical Products Factory BENZALKONIUM CHLORIDE .13 mg/1 N 20181231 71222-006_50e33053-55f4-29f8-e054-00144ff8d46c 71222-006 HUMAN OTC DRUG Sterile Saline Eyewash water SOLUTION OPHTHALMIC 20140520 OTC MONOGRAPH FINAL part349 Tongzhou Deqi Medical Products Factory WATER .987 mL/mL N 20181231 71223-001_5f516e6e-3079-7cd0-e053-2991aa0a2e0b 71223-001 HUMAN OTC DRUG Amosan Oral Wound Cleanser SODIUM PERBORATE MONOHYDRATE POWDER, FOR SOLUTION TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part356 Vintage Brands Limited SODIUM PERBORATE MONOHYDRATE 1.2 g/1.7g N 20181231 71224-0001_47eaf4e6-fc65-64c1-e054-00144ff88e88 71224-0001 HUMAN OTC DRUG Perfect V Lifting Premium Mask ADENOSINE LIQUID TOPICAL 20170101 UNAPPROVED DRUG OTHER AVAJAR CO LTD ADENOSINE .04 g/100g N 20181231 71224-0002_6266d9ec-f170-be73-e053-2a91aa0a53f8 71224-0002 HUMAN OTC DRUG Perfect V Lifting Premium Mask GLYCERIN LIQUID TOPICAL 20180101 OTC MONOGRAPH FINAL part347 AVAJAR CO LTD GLYCERIN 30 g/100g N 20191231 71224-0003_62764270-0f90-269e-e053-2991aa0ad2c6 71224-0003 HUMAN OTC DRUG Perfect V Lifting Premium Black Mask GLYCERIN LIQUID TOPICAL 20180101 OTC MONOGRAPH FINAL part347 AVAJAR CO LTD GLYCERIN 30 g/100g N 20191231 71224-0004_627676ce-3ead-6c56-e053-2a91aa0a4d5d 71224-0004 HUMAN OTC DRUG Perfect V Lifting Premium Black Mask GLYCERIN LIQUID TOPICAL 20180101 OTC MONOGRAPH FINAL part347 AVAJAR CO LTD GLYCERIN 30 g/100g N 20191231 71224-0005_62778a3c-0ed4-2d0d-e053-2a91aa0a09c9 71224-0005 HUMAN OTC DRUG Perfect V Lifting Premium Eye Mask GLYCERIN LIQUID TOPICAL 20180101 OTC MONOGRAPH FINAL part347 AVAJAR CO LTD GLYCERIN 30 g/100g N 20191231 71224-0006_62790979-d6a6-3bc9-e053-2a91aa0a3fd4 71224-0006 HUMAN OTC DRUG QUICK CLEANSING DRY TISSUE GLYCERIN LIQUID TOPICAL 20180101 OTC MONOGRAPH FINAL part347 AVAJAR CO LTD GLYCERIN .8 g/100g N 20191231 71226-001_f8dc6d39-77d2-4555-b0c7-b20e64dfa967 71226-001 HUMAN OTC DRUG PainBloc24 Capsaicin 0.25% SOLUTION TOPICAL 20170321 OTC MONOGRAPH NOT FINAL part348 Vizuri Health Sciences LLC CAPSAICIN 2.5 mg/mL N 20181231 71230-001_48aa162a-5478-1ce0-e054-00144ff88e88 71230-001 HUMAN OTC DRUG Sodium Bicarbonate Antacid SODIUM BICARBONATE POWDER ORAL 20170216 OTC MONOGRAPH FINAL part331 Compania Farmaceutica, S.A. de C.V. SODIUM BICARBONATE 1 g/g N 20181231 71233-001_53c9dc20-1392-450f-98cb-cbc986c25abd 71233-001 HUMAN OTC DRUG Detox Beta vulg, Boldo, Chelidonium maj, Sarsaparilla, Gelsemium, Veratrum alb, Ferrum met, Iodium, Lycopodium, Nux vom, Pulsatilla, Selenium, Thuja occ, Zinc met LIQUID ORAL 20170403 UNAPPROVED HOMEOPATHIC Compass Fat Loss of Glastonbury LLC BETA VULGARIS; PEUMUS BOLDUS LEAF; CHELIDONIUM MAJUS; SMILAX ORNATA ROOT; GELSEMIUM SEMPERVIRENS ROOT; VERATRUM ALBUM ROOT; IRON; IODINE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; SELENIUM; THUJA OCCIDENTALIS LEAFY TWIG; ZINC 3; 3; 3; 6; 7; 7; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 71233-002_95d3eac5-f39d-4744-a371-2b0bc1a134b3 71233-002 HUMAN OTC DRUG Weight Management Asclepias vinc, Echinacea, Hypothalamus, Cerebrum suis, Hepar suis, Kidney, Methylcobalamin, Pancreas suis, Stomach suis, AACG-A, AACG-B, Calc carb, Gambogia, Gelsemium, Graphites, Nat mur, Nux vom, Phytolacca, 3-acetyl-7-oxo-dehydroepiandrosterone, ATP, Glucagon, Insulinum, Sarcolacticum ac, Proteus LIQUID ORAL 20170403 UNAPPROVED HOMEOPATHIC Compass Fat Loss of Glastonbury LLC CYNANCHUM VINCETOXICUM ROOT; ECHINACEA, UNSPECIFIED; SUS SCROFA CEREBRUM; PORK LIVER; EUTROCHIUM PURPUREUM WHOLE; METHYLCOBALAMIN; SUS SCROFA PANCREAS; TRIPE; APC-356433; APC-356434; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GAMBOGE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; 7-KETO-DEHYDROEPIANDROSTERONE; ADENOSINE TRIPHOSPHATE DISODIUM; GLUCAGON; INSULIN PORK; LACTIC ACID, L-; PROTEUS VULGARIS 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_C]/59mL N 20181231 71235-001_477dd4f0-d698-5d3b-e054-00144ff8d46c 71235-001 HUMAN OTC DRUG Megaplast Feet Wart Removal SALICYLIC ACID PLASTER TOPICAL 20170714 OTC MONOGRAPH FINAL part358B EUROSIREL SPA SALICYLIC ACID 5.51 mg/1 N 20181231 71235-002_477e0732-6840-6617-e054-00144ff8d46c 71235-002 HUMAN OTC DRUG Megaplast - Feet Corn Removal Plaster SALICYLIC ACID PLASTER TOPICAL 20170714 OTC MONOGRAPH FINAL part358F EUROSIREL SPA SALICYLIC ACID 3.175 mg/1 N 20181231 71235-003_477e0732-6843-6617-e054-00144ff8d46c 71235-003 HUMAN OTC DRUG Megaplast - Feet Corn Protective Plasters SALICYLIC ACID PLASTER TOPICAL 20170714 OTC MONOGRAPH FINAL part358F EUROSIREL SPA SALICYLIC ACID 2.068 mg/1 N 20181231 71235-004_477e0732-6845-6617-e054-00144ff8d46c 71235-004 HUMAN OTC DRUG Megaplast - Clarifying Acne Patches SALICYLIC ACID PATCH TOPICAL 20170714 OTC MONOGRAPH FINAL part333D EUROSIREL SPA SALICYLIC ACID .056 mg/1 N 20181231 71237-001_47d49880-1111-5484-e054-00144ff8d46c 71237-001 HUMAN OTC DRUG KAEWOON GLYCERIN, ALLANTOIN GEL TOPICAL 20170202 UNAPPROVED DRUG OTHER rnkorea.co.ltd GLYCERIN; ALLANTOIN 30; 2 mg/mL; mg/mL N 20181231 71237-002_548ca7ec-68c1-2e7c-e054-00144ff88e88 71237-002 HUMAN OTC DRUG KAEWOON Menthol SHAMPOO TOPICAL 20170713 UNAPPROVED DRUG OTHER rnkorea.co.ltd MENTHOL, UNSPECIFIED FORM 1 mg/mL N 20181231 71238-785_47f6ab9e-fa49-496a-e054-00144ff8d46c 71238-785 HUMAN OTC DRUG LBri Pure nNatural Oil Free Moisturizer OCTINOXATE, AVOBENZONE, OCTISALATE CREAM TOPICAL 20170207 OTC MONOGRAPH NOT FINAL part352 L'Bri Health & Beauty OCTINOXATE; AVOBENZONE; OCTISALATE 75; 30; 30 mg/mL; mg/mL; mg/mL N 20181231 71238-847_5aa7289a-999f-47be-e053-2991aa0ad7b0 71238-847 HUMAN OTC DRUG LBri Super Aloe Stop The Pain METHYL SALICYLATE, MENTHOL, CAPSAICIN CREAM TOPICAL 20171003 OTC MONOGRAPH NOT FINAL part348 L'Bris, Pure 'N Natural METHYL SALICYLATE; MENTHOL; CAPSAICIN 100; 30; .3 mg/mL; mg/mL; mg/mL N 20181231 71238-857_5b5a74a5-b522-0776-e053-2991aa0ab5b2 71238-857 HUMAN OTC DRUG LBri Pure N Natural Diaper ZINC OXIDE CREAM TOPICAL 20171012 OTC MONOGRAPH FINAL part347 L'Bri Health and Beauty ZINC OXIDE 200 mg/mL N 20181231 71239-786_47f6ab9e-fa77-496a-e054-00144ff8d46c 71239-786 HUMAN OTC DRUG Dr. Mercola Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170207 OTC MONOGRAPH NOT FINAL part352 Nature's Health Partner, LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 225 mg/mL; mg/mL N 20181231 71239-787_47f6f349-88f5-19d2-e054-00144ff88e88 71239-787 HUMAN OTC DRUG Dr. Mercola Broad Spectrum ZINC OXIDE CREAM TOPICAL 20170207 OTC MONOGRAPH NOT FINAL part352 Nature's Health Partner, LLC ZINC OXIDE 200 mg/mL N 20181231 71239-788_47f6ec0a-1159-55dd-e054-00144ff8d46c 71239-788 HUMAN OTC DRUG Dr Mercola Broad Spectrum SPF15 ZINC OXIDE CREAM TOPICAL 20170207 OTC MONOGRAPH NOT FINAL part352 Nature's Health Partner, LLC ZINC OXIDE 95 mg/mL N 20181231 71240-231_52a82e47-a2fe-48dc-e054-00144ff88e88 71240-231 HUMAN OTC DRUG Nuby Teething Gel Teething Gel GEL TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part356 Ningbo Longwell Baby Products Co Ltd EUGENOL 8 mg/g N 20181231 71241-001_5f3b48d0-58ea-3827-e053-2991aa0a7bdd 71241-001 HUMAN OTC DRUG BIOCORNEUM PLUS SPF 30 ADVANCED SCAR TREATMENT Octinoxate Octisalate Octocrylene Oxybenzone GEL TOPICAL 20160309 OTC MONOGRAPH FINAL part352 SIENTRA, INC. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 10; 6 g/100g; g/100g; g/100g; g/100g N 20181231 71241-001_5f3b5e21-38fb-59d5-e053-2991aa0adc61 71241-001 HUMAN OTC DRUG BIOCORNEUM PLUS SPF 30 ADVANCED SCAR TREATMENT Octinoxate Octisalate Octocrylene Oxybenzone GEL TOPICAL 20171201 OTC MONOGRAPH FINAL part352 SIENTRA, INC. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 10; 6 g/100g; g/100g; g/100g; g/100g N 20181231 71241-001_5f3bc292-f67e-998a-e053-2a91aa0a1782 71241-001 HUMAN OTC DRUG BIOCORNEUM PLUS SPF 30 ADVANCED SCAR TREATMENT Octinoxate Octisalate Octocrylene Oxybenzone GEL TOPICAL 20160309 OTC MONOGRAPH FINAL part352 SIENTRA, INC. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 10; 6 g/100g; g/100g; g/100g; g/100g N 20181231 71241-001_5f3bc292-f692-998a-e053-2a91aa0a1782 71241-001 HUMAN OTC DRUG BIOCORNEUM PLUS SPF 30 ADVANCED SCAR TREATMENT Octinoxate Octisalate Octocrylene Oxybenzone GEL TOPICAL 20160309 OTC MONOGRAPH FINAL part352 SIENTRA, INC. OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 7.5; 5; 10; 6 g/100g; g/100g; g/100g; g/100g N 20181231 71245-102_48878bce-cdf4-70db-e054-00144ff8d46c 71245-102 HUMAN OTC DRUG Candy Doll Bright Pure Base titanium dioxide, zinc oxide LOTION TOPICAL 20170213 OTC MONOGRAPH FINAL part352 T-Garden Inc ZINC OXIDE; TITANIUM DIOXIDE 1.59; 1.86 g/30g; g/30g N 20181231 71245-104_4898a0ca-0f92-3da0-e054-00144ff8d46c 71245-104 HUMAN OTC DRUG Candy Doll White Pure Powder Normal titanium dioxide, zinc oxide POWDER TOPICAL 20170213 OTC MONOGRAPH FINAL part352 T-Garden Inc ZINC OXIDE; TITANIUM DIOXIDE .194; .7 g/10g; g/10g N 20181231 71245-106_489979ef-1ac5-4caa-e054-00144ff88e88 71245-106 HUMAN OTC DRUG Candy Doll White Pure Powder Shiny titanium dioxide, zinc oxide POWDER TOPICAL 20170213 OTC MONOGRAPH FINAL part352 T-Garden Inc ZINC OXIDE; TITANIUM DIOXIDE .194; .672 g/10g; g/10g N 20181231 71245-108_4b2d0a17-3109-73bf-e054-00144ff8d46c 71245-108 HUMAN OTC DRUG Candy Doll Liquid Foundation titanium dioxide, ethlyhexyl methoxycinnamate LIQUID TOPICAL 20170320 OTC MONOGRAPH FINAL part352 T-Garden Inc TITANIUM DIOXIDE; OCTINOXATE 2.43; .9 g/30g; g/30g N 20181231 71245-110_597eec6d-7cfe-d0ef-e053-2991aa0a0181 71245-110 HUMAN OTC DRUG Candy Doll Basic Bright Pure Base Mint Green titanium dioxide, zinc oxide LOTION TOPICAL 20170918 OTC MONOGRAPH FINAL part352 T-Garden Inc ZINC OXIDE; TITANIUM DIOXIDE 1.59; 1.86 g/30g; g/30g N 20181231 71246-3001_9562765b-ee04-4780-bed7-43a4f21da2c1 71246-3001 HUMAN OTC DRUG Hand Sanitizer BlowPop Cherry Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71246-3002_a06ad05d-b128-45fd-b955-914351ef8f0a 71246-3002 HUMAN OTC DRUG Hand Sanitizer Razz Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71246-3003_a9eaa2f2-433d-45f6-89d4-f8e36311d0cb 71246-3003 HUMAN OTC DRUG Hand Sanitizer Sour Apple Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71246-3004_41972d59-05c7-448e-9978-76828e3b941b 71246-3004 HUMAN OTC DRUG Hand Sanitizer Watermellon Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71246-3005_0f67f0e8-fff8-4738-82a0-65318de2b01a 71246-3005 HUMAN OTC DRUG Hand Sanitizer Lemon Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71246-3006_fe363be4-34fb-458e-9dd9-5643ffcfdad2 71246-3006 HUMAN OTC DRUG Hand Sanitizer Lime Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71246-3007_2a8befbf-a8a6-439b-a47f-c4e47197eee8 71246-3007 HUMAN OTC DRUG Hand Sanitizer Strawberry Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71246-3008_e70c0d45-77f5-499f-80d0-93ecba91ccda 71246-3008 HUMAN OTC DRUG Hand Sanitizer Pink Lemonade Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71246-3009_158595ba-5c4f-451d-926f-1b6ae4d1b063 71246-3009 HUMAN OTC DRUG Hand Sanitizer Bubble Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71246-3010_2e50ee8c-1eb4-45f9-9a22-7fd109aec05f 71246-3010 HUMAN OTC DRUG Hand Sanitizer Grape Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71246-3011_dedf4beb-31ac-4326-8d32-cbfc5e48e09d 71246-3011 HUMAN OTC DRUG Hand Sanitizer Raspberry Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71246-3012_dabd2c17-3908-45ea-8935-b6db0332de02 71246-3012 HUMAN OTC DRUG Hand Sanitizer Chocolate Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71246-3013_c9e0460a-6973-4806-8103-7832d08f3bad 71246-3013 HUMAN OTC DRUG Hand Sanitizer Orange Alcohol SWAB TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part333A JFL ENTERPRISES, INC ALCOHOL 65 mL/100mL N 20181231 71248-001_3d984d4a-4176-4dda-94fd-017f57e8c228 71248-001 HUMAN PRESCRIPTION DRUG Anodyne LPT lidocaine and prilocaine KIT TOPICAL 20170322 NDA AUTHORIZED GENERIC NDA019941 Fortus Pharma, LLC N 20181231 71248-002_862590b2-26a2-45e0-8f30-f686d427a11c 71248-002 HUMAN PRESCRIPTION DRUG ANODYNE ILE ANODYNE ILE KIT 20171016 ANDA ANDA076925 Fortus Pharma, LLC N 20181231 71248-003_a37aea35-7444-4826-8543-25d66d84898a 71248-003 HUMAN PRESCRIPTION DRUG DiThol diclofenac sodium/menthol KIT 20171222 ANDA ANDA203818 Fortus Pharma, LLC N 20181231 71250-002_a98f3fa6-855b-4cbb-ba33-90bdd7e521b1 71250-002 HUMAN OTC DRUG Dermacline Tetracycline Hydrochloride OINTMENT TOPICAL 20161108 OTC MONOGRAPH FINAL part333B Inventus, LLC TETRACYCLINE HYDROCHLORIDE 30 mg/mL N 20181231 71251-0001_5e137769-2ac2-cf79-e053-2a91aa0a7573 71251-0001 HUMAN OTC DRUG BIGGREEN EVERYDAY SUN Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170220 OTC MONOGRAPH FINAL part352 BIGGREEN INC. TITANIUM DIOXIDE; ZINC OXIDE 11.25; 4.85 g/100g; g/100g N 20181231 71252-010_13431018-2e21-4ae4-a251-5c9119b04d1f 71252-010 HUMAN OTC DRUG QUEENS ROSE RECOVERY TONER Niacinamide, Adenosine LIQUID TOPICAL 20170302 UNAPPROVED DRUG OTHER Cdpharmtec Co.,ltd NIACINAMIDE; ADENOSINE 2.4; .048 g/120mL; g/120mL N 20181231 71252-020_0ea539aa-4908-44e2-9f35-ede1e46b5a09 71252-020 HUMAN OTC DRUG QUEENS ROSE RECOVERY Niacinamide, Adenosine EMULSION TOPICAL 20170302 UNAPPROVED DRUG OTHER Cdpharmtec Co.,ltd NIACINAMIDE; ADENOSINE 2.2; .044 g/110mL; g/110mL N 20181231 71252-030_6b1cdd03-d3ba-49f3-993e-71366a6735e9 71252-030 HUMAN OTC DRUG QUEENS ROSE RECOVERY SERUM Dimethicone LIQUID TOPICAL 20170302 OTC MONOGRAPH FINAL part347 Cdpharmtec Co.,ltd DIMETHICONE .9 g/45mL N 20181231 71252-040_3da196f1-6503-4e5d-b448-29fba54c274c 71252-040 HUMAN OTC DRUG QUEENS ROSE RECOVERY EYE Niacinamide, Adenosine CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER Cdpharmtec Co.,ltd NIACINAMIDE; ADENOSINE .6; .012 g/30mL; g/30mL N 20181231 71252-050_1c8c8a77-7946-4c3e-a986-49736b92f617 71252-050 HUMAN OTC DRUG QUEENS ROSE RECOVERY Niacinamide, Adenosine CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER Cdpharmtec Co.,ltd NIACINAMIDE; ADENOSINE 1.2; .024 g/60g; g/60g N 20181231 71252-060_d9fd7270-e289-44b7-8cb6-5d84dfe4b291 71252-060 HUMAN OTC DRUG QUEENS ROSE RECOVERY SHEET MASK ROSA CENTIFOLIA FLOWER WATER PATCH TOPICAL 20170302 UNAPPROVED DRUG OTHER Cdpharmtec Co.,ltd ROSA CENTIFOLIA FLOWER OIL 1.5 g/25mL N 20181231 71252-070_9430fe66-ecf7-488d-9318-7d8eec9cef87 71252-070 HUMAN OTC DRUG QUEENS ROSE ELYSEE ESSENCE EYE Dimethicone CREAM TOPICAL 20170302 OTC MONOGRAPH FINAL part347 Cdpharmtec Co.,ltd DIMETHICONE 1.25 g/50g N 20181231 71252-080_1b33137c-9659-459c-b525-8d4469bc7305 71252-080 HUMAN OTC DRUG QUEENS ROSE ELYSEE Dimethicone CREAM TOPICAL 20170302 OTC MONOGRAPH FINAL part347 Cdpharmtec Co.,ltd DIMETHICONE 5.41 g/50g N 20181231 71252-090_7440975a-d1f4-4f8c-98e8-c5b2543015e5 71252-090 HUMAN OTC DRUG QUEENS ROSE ELYSEE CONCEN TRATE DUAL AMPOULE Glycerin LIQUID TOPICAL 20170302 UNAPPROVED DRUG OTHER Cdpharmtec Co.,ltd GLYCERIN .19 g/8g N 20181231 71252-100_369b723e-4450-4812-8a06-b92773bd7558 71252-100 HUMAN OTC DRUG QUEENS ROSE WHOLE IN ONE SUNBLOCK OCTINOXATE, OCTISALATE, ENSULIZOLE, AVOBENZONE CREAM TOPICAL 20170302 OTC MONOGRAPH NOT FINAL part352 Cdpharmtec Co.,ltd OCTINOXATE; OCTISALATE; ENSULIZOLE; AVOBENZONE 2.75; 2.5; 2; 1.5 g/50g; g/50g; g/50g; g/50g N 20181231 71252-110_8eac3200-690a-4321-99f7-6a9ba8e163e0 71252-110 HUMAN OTC DRUG QUEENS ROSE ROSE SKIN PERFECTION BB Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170302 OTC MONOGRAPH NOT FINAL part352 Cdpharmtec Co.,ltd TITANIUM DIOXIDE; ZINC OXIDE 6.69; .72 g/50g; g/50g N 20181231 71252-120_6d1e15ad-fc4f-47a2-a26f-cfc9c555f1b1 71252-120 HUMAN OTC DRUG QUEENS ROSE PERFECTION COVER CUSHION PACT Titanium Dioxide, Octinoxate, Zinc Oxide, Octisalate POWDER TOPICAL 20170302 OTC MONOGRAPH NOT FINAL part352 Cdpharmtec Co.,ltd TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE; OCTISALATE 1.15; .84; .58; .54 g/12g; g/12g; g/12g; g/12g N 20181231 71253-010_69f2456c-695c-4a5a-b64b-c82690e20db7 71253-010 HUMAN OTC DRUG Honesi exofila Niacinamide, Adenosine CREAM TOPICAL 20170201 UNAPPROVED DRUG OTHER Originway Co., Ltd. NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 71261-001_2f575967-a0fc-4de6-97c0-f055f176ee09 71261-001 HUMAN OTC DRUG JUNGSAEMMOOL Essential Skin Nuder Cushion Light TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20171218 OTC MONOGRAPH NOT FINAL part352 Jungsaemmool Beauty Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 131.9; 67; 40 mg/g; mg/g; mg/g N 20181231 71261-002_6744ad29-e4fa-4d89-9e00-29de14dd6002 71261-002 HUMAN OTC DRUG JUNGSAEMMOOL Essential Skin Nuder Cushion Medium TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20171218 OTC MONOGRAPH NOT FINAL part352 Jungsaemmool Beauty Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 131.9; 67; 40 mg/g; mg/g; mg/g N 20181231 71261-003_4b66407f-4c7a-442a-9010-07f2f0fa2d01 71261-003 HUMAN OTC DRUG JUNGSAEMMOOL Essential Skin Nuder Cushion Medium Deep TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE CREAM TOPICAL 20171218 OTC MONOGRAPH NOT FINAL part352 Jungsaemmool Beauty Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 131.9; 67; 40 mg/g; mg/g; mg/g N 20181231 71261-004_01821972-f104-45bb-aabd-69a828fbc828 71261-004 HUMAN OTC DRUG JUNGSAEMMOOL Essential Star cealer Foundation Light TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20171205 OTC MONOGRAPH NOT FINAL part352 Jungsaemmool Beauty Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 128; 40; 9.8 mg/g; mg/g; mg/g N 20181231 71261-005_f084e3f0-9af1-4d58-9a1c-4537718603d7 71261-005 HUMAN OTC DRUG JUNGSAEMMOOL Essential Star cealer Foundation Medium Deep TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20171206 OTC MONOGRAPH NOT FINAL part352 Jungsaemmool Beauty Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 126.3; 40; 9.3 mg/g; mg/g; mg/g N 20181231 71261-006_78e9d6a1-c6a2-4a82-ae9d-63e6c443f177 71261-006 HUMAN OTC DRUG JUNGSAEMMOOL Essential Star cealer Foundation Medium TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20171206 OTC MONOGRAPH NOT FINAL part352 Jungsaemmool Beauty Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 128; 40; 9.8 mg/g; mg/g; mg/g N 20181231 71261-007_e025f6b7-a4ac-4774-8c48-8c52a19f602a 71261-007 HUMAN OTC DRUG JUNGSAEMMOOL Essential Star cealer Foundation Fair Light TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20171020 OTC MONOGRAPH NOT FINAL part352 Jungsaemmool Beauty Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 128; 40; 9.8 mg/g; mg/g; mg/g N 20181231 71262-002_dfe8b3bd-37a7-446d-a652-efe1d415a398 71262-002 HUMAN OTC DRUG VitaStem Tetracycline Hydrochloride OINTMENT TOPICAL 20161108 OTC MONOGRAPH FINAL part333B BIOGENX INC TETRACYCLINE HYDROCHLORIDE 30 mg/mL N 20181231 71263-9901_4a3ac598-6e03-1c75-e054-00144ff88e88 71263-9901 HUMAN OTC DRUG Stress Relief Honzo Seika Chinese Herbal Aroma Oil Stress Relief OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER NIC CO., LTD. ASIAN GINSENG 7 mg/100mL N 20181231 71263-9902_4a3abb31-bf84-42ed-e054-00144ff8d46c 71263-9902 HUMAN OTC DRUG Lung Care Honzo Seika Chinese Herbal Aroma Oil Lung Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER NIC CO., LTD. ANGELICA DAHURICA ROOT 33 mg/100mL N 20181231 71263-9903_4a3abb31-bf90-42ed-e054-00144ff8d46c 71263-9903 HUMAN OTC DRUG Blood Care Honzo Seika Chinese Herbal Aroma Oil Blood Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER NIC CO., LTD. ASIAN GINSENG; ANGELICA SINENSIS ROOT 8.5; 3 mg/100mL; mg/100mL N 20181231 71263-9904_4a4e80d3-1e0d-41c5-e054-00144ff88e88 71263-9904 HUMAN OTC DRUG Slim Care Honzo Seika Chinese Herbal Aroma Oil Slim Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER NIC CO., LTD. SCUTELLARIA LATERIFLORA 18 mg/100mL N 20181231 71263-9905_4a4e80d3-1e79-41c5-e054-00144ff88e88 71263-9905 HUMAN OTC DRUG Breast Care Honzo Seika Chinese Herbal Aroma Oil Breast Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER NIC CO., LTD. ANGELICA SINENSIS ROOT 12.5 mg/100mL N 20181231 71263-9906_4a4e80d3-1e85-41c5-e054-00144ff88e88 71263-9906 HUMAN OTC DRUG Digestive Care Honzo Seika Chinese Herbal Aroma Oil Digestive Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER NIC CO., LTD. PEPPERMINT 28 mg/100mL N 20181231 71263-9912_4a4eeef6-4cfc-5b93-e054-00144ff8d46c 71263-9912 HUMAN OTC DRUG Female Care Honzo Seika Chinese Herbal Aroma Oil Female Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER NIC CO., LTD. SALVIA MILTIORRHIZA ROOT 6 mg/100mL N 20181231 71263-9915_4a4e80d3-1e9d-41c5-e054-00144ff88e88 71263-9915 HUMAN OTC DRUG Pain Relief Honzo Seika Chinese Herbal Aroma Oil Pain Relief OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER NIC CO., LTD. GINGER 28 mg/100mL N 20181231 71263-9917_4a3abb31-bf77-42ed-e054-00144ff8d46c 71263-9917 HUMAN OTC DRUG Anti-Cellulite Honzo Seika Chinese Herbal Aroma Oil Anti-Cellulite OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER NIC CO., LTD. ATRACTYLODES LANCEA ROOT OIL 15 mg/100mL N 20181231 71263-9931_4a4e80d3-1eac-41c5-e054-00144ff88e88 71263-9931 HUMAN OTC DRUG Liver Care Honzo Seika Chinese Herbal Aroma Oil Liver Care OIL TOPICAL 20160401 UNAPPROVED DRUG OTHER NIC CO., LTD. ASIAN GINSENG 46 mg/100mL N 20181231 71264-101_2e91de54-d8f1-4acd-8011-5632b21e3f27 71264-101 HUMAN OTC DRUG HYDRATING FACIAL SPF-30 AVOBENZONE, MERADIMATE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20160907 OTC MONOGRAPH NOT FINAL part352 VU SKIN SYSTEM, INC. AVOBENZONE; MERADIMATE; OCTINOXATE; OCTISALATE 3; 5; 7.5; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 71265-001_49c230fb-544d-0a1a-e054-00144ff88e88 71265-001 HUMAN OTC DRUG Yours Pure Petroleum White Petrolatum JELLY TOPICAL 20170302 OTC MONOGRAPH FINAL part347 TRANSWORLD INTERNATIONAL TRADING CORP. PETROLATUM 100 g/100g N 20181231 71265-002_49c2496f-87b3-1607-e054-00144ff8d46c 71265-002 HUMAN OTC DRUG Yours Baby Fresh Scent Petroleum White Petrolatum JELLY TOPICAL 20170302 OTC MONOGRAPH FINAL part347 TRANSWORLD INTERNATIONAL TRADING CORP. PETROLATUM 99.9 g/100g N 20181231 71270-150_c8549dc7-ec86-41d3-9a58-534f18706647 71270-150 HUMAN OTC DRUG TRADER JOE S MINERAL SUNSCREEN Zinc Oxide STICK TOPICAL 20170225 OTC MONOGRAPH NOT FINAL part352 Trader Joe's Company ZINC OXIDE 22 g/100g N 20181231 71270-581_647dadae-f37b-8399-e053-2991aa0aedb3 71270-581 HUMAN OTC DRUG Honey Lemon Cough Drops MENTHOL LOZENGE ORAL 20180101 OTC MONOGRAPH FINAL part341 Trader Joe's Company MENTHOL 6 mg/1 N 20191231 71270-612_8f4d73b9-276f-49f7-9476-3de3c9a50dcb 71270-612 HUMAN OTC DRUG LIP TREATMENT DUO LIP SCRUB AND LIP BALM SUNSCREEN SPF 15 Octinoxate, Oxybenzone KIT 20170808 OTC MONOGRAPH NOT FINAL part352 Trader Joe's Company N 20181231 71271-100_03e127f6-575c-4b15-a59b-2ac1eaecbf9f 71271-100 HUMAN OTC DRUG Eyewash PURIFIED WATER LIQUID TOPICAL 20170703 OTC MONOGRAPH FINAL part349 Reliance Medical Ltd WATER .991 mL/mL N 20191231 71271-100_1872b6d4-b171-4c2f-ad60-a1e7e21872d3 71271-100 HUMAN OTC DRUG Eyewash PURIFIED WATER LIQUID TOPICAL 20170703 OTC MONOGRAPH FINAL part349 Reliance Medical Ltd WATER .991 mL/mL N 20191231 71272-811_499d366a-a7f5-6070-e054-00144ff88e88 71272-811 HUMAN OTC DRUG Sunstation All-Natural SPF 30 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20170228 OTC MONOGRAPH NOT FINAL part352 Sunstation USA, LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/g; mg/g N 20181231 71273-001_49845881-b0df-5867-e054-00144ff8d46c 71273-001 HUMAN OTC DRUG EVOTE WHITE CARBON COMPLEXTM DAY ANTI AGING PROTECT AND ILLUMINATE BROAD SPECTRUM SPF 25 ZINC OXIDE CREAM TOPICAL 20170225 OTC MONOGRAPH NOT FINAL part352 JSB4, LLC ZINC OXIDE 168 mg/mL N 20181231 71273-002_617df787-d20b-674e-e053-2a91aa0ac7d4 71273-002 HUMAN OTC DRUG EVOTE WHITE CARBON COMPLEXTM DAY EYE ANTI-AGING PROTECT,FIRM,BRIGHTEN BROAD SPECTRUM SPF 15 SERUM ZINC OXIDE CREAM TOPICAL 20170226 OTC MONOGRAPH NOT FINAL part352 JSB4, LLC ZINC OXIDE 101 mg/mL N 20181231 71273-015_4f905beb-c812-6758-e054-00144ff8d46c 71273-015 HUMAN OTC DRUG EVOTE WHITE CARBON COMPLEXTM DAY EYE SERUM ANTI-AGING PROTECT,FIRM,BRIGHTEN BROAD SPECTRUM SPF 15 ZINC OXIDE CREAM TOPICAL 20170506 OTC MONOGRAPH NOT FINAL part352 Jsb4, LLC ZINC OXIDE 101 mg/mL N 20181231 71275-001_53bbe10e-3a11-106d-e054-00144ff88e88 71275-001 HUMAN OTC DRUG BURST Wonderfully Whitening Anti Cavity Sodium fluoride PASTE, DENTIFRICE DENTAL 20170220 OTC MONOGRAPH FINAL part355 BURST.USA.Inc SODIUM FLUORIDE .243 mg/g N 20181231 71276-010_7eadf012-142c-4823-93e8-2c9819cff02f 71276-010 HUMAN OTC DRUG VITALISING TONIC GLYCERIN LOTION TOPICAL 20170302 UNAPPROVED DRUG OTHER ULAB GLYCERIN 8.28 g/180mL N 20181231 71276-020_c2021fc0-a345-4cf5-b2b5-2b9382b1d720 71276-020 HUMAN OTC DRUG NATURAL SAVON 4IN1 PLUS GLYCERIN CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER ULAB GLYCERIN 8.6 g/200mL N 20181231 71276-030_96554491-7942-40b2-9fda-9b0c9c28fa5a 71276-030 HUMAN OTC DRUG NYMPHSYN FACE MASK GLYCERIN CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER ULAB GLYCERIN 1.4 g/50mL N 20181231 71276-040_cb5d971b-751f-466d-975e-fddf9126a128 71276-040 HUMAN OTC DRUG NYMPHSYN EYE GLYCERIN CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER ULAB GLYCERIN .29 g/30mL N 20181231 71276-050_d498810f-39f2-4b88-9b00-80c7df2d8e0e 71276-050 HUMAN OTC DRUG NYMPHSYN INTENSIVE SERUM GLYCERIN CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER ULAB GLYCERIN 1.97 g/30mL N 20181231 71276-060_10da585a-3e5b-4a0a-b958-43e26013c018 71276-060 HUMAN OTC DRUG NYMPHSYN MAXIMIZER GLYCERIN CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER ULAB GLYCERIN 3.14 g/50mL N 20181231 71276-070_f89a76b1-1135-45d8-a905-6ec5fe3f8659 71276-070 HUMAN OTC DRUG OXY STEM M SERUM DIMETHICONE CREAM TOPICAL 20170302 OTC MONOGRAPH FINAL part347 ULAB DIMETHICONE 1 g/50mL N 20181231 71276-080_8712c4a5-f1fb-46c7-aa29-44bd1a8d0ab1 71276-080 HUMAN OTC DRUG OXY STEM M DIMETHICONE CREAM TOPICAL 20170302 OTC MONOGRAPH FINAL part347 ULAB DIMETHICONE 7.06 g/50mL N 20181231 71276-090_08a33e6f-915f-4f1c-8cfc-91cba2d1352d 71276-090 HUMAN OTC DRUG ULTRA REPAIR SHEA BUTTER CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER ULAB SHEA BUTTER 2.4 g/60mL N 20181231 71276-100_f8a723fb-dfb4-49ad-b52d-0f812825214e 71276-100 HUMAN OTC DRUG HYDRA C3 TRIPLE RESET WITCH HAZEL CREAM TOPICAL 20170302 OTC MONOGRAPH FINAL part347 ULAB WITCH HAZEL 3 g/60mL N 20181231 71276-110_ccc2b756-774e-4afe-903e-ad27a1607459 71276-110 HUMAN OTC DRUG G3S AMPOULE GLYCERIN LIQUID TOPICAL 20170302 UNAPPROVED DRUG OTHER ULAB GLYCERIN .02 g/2mL N 20181231 71276-120_ba2089ba-60d7-4b38-8792-abcc76c65337 71276-120 HUMAN OTC DRUG ULTRA REJUVE 7S AMPOULE GLYCERIN LIQUID TOPICAL 20170302 UNAPPROVED DRUG OTHER ULAB GLYCERIN .04 g/5mL N 20181231 71276-130_22faf207-754a-4672-9b45-46583e05bf78 71276-130 HUMAN OTC DRUG PEPTICOL 5S AMPOULE GLYCERIN LIQUID TOPICAL 20170302 UNAPPROVED DRUG OTHER ULAB GLYCERIN .29 g/5mL N 20181231 71276-140_3343cda2-e52d-4013-afed-601459a29267 71276-140 HUMAN OTC DRUG HYALURON 3S SERUM HYALURONIC ACID CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER ULAB HYALURONIC ACID .15 g/50mL N 20181231 71276-150_641841f0-f907-4fe0-ac77-5eeff620fc42 71276-150 HUMAN OTC DRUG RESURFACE MASK GLYCERIN CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER ULAB GLYCERIN 2.04 g/30mL N 20181231 71278-005_61428f45-2509-4392-e053-2a91aa0a2656 71278-005 HUMAN OTC DRUG Perfect Legs Skin Protector SPF 30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE CREAM TOPICAL 20170513 OTC MONOGRAPH NOT FINAL part352 THIS WORKS PRODUCTS LIMITED AVOBENZONE; OCTINOXATE; OCTOCRYLENE 16; 16; 8 mg/mL; mg/mL; mg/mL N 20181231 71278-006_6142873b-4523-10c0-e053-2991aa0a4aac 71278-006 HUMAN OTC DRUG In Transit Skin Defence AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20170517 OTC MONOGRAPH NOT FINAL part352 THIS WORKS PRODUCTS LIMITED AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 30; 70; 95; 60 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71282-001_54ae6f4b-cf3c-09e4-e054-00144ff88e88 71282-001 HUMAN OTC DRUG 4Jointz eucalyptus oil, tannic acid, allantoin CREAM TOPICAL 20170131 OTC MONOGRAPH NOT FINAL part348 ARP(USA) Pty Ltd TANNIC ACID; ALLANTOIN; EUCALYPTUS OIL 5; .025; 4 g/100g; g/100g; g/100g N 20181231 71282-011_40d20a6c-2e63-4ee3-a98d-b185b9ff7901 71282-011 HUMAN OTC DRUG 4Jointz Menthol CREAM TOPICAL 20170131 OTC MONOGRAPH NOT FINAL part348 ARP(USA) Pty Ltd MENTHOL 1.5 g/100g N 20191231 71287-119_51bfd1c5-cbb2-48a1-a390-472955fefe1a 71287-119 CELLULAR THERAPY YESCARTA axicabtagene ciloleucel SUSPENSION INTRAVENOUS 20171018 BLA BLA125643 Kite Pharma, Inc. AXICABTAGENE CILOLEUCEL 2000000 1/68mL N 20181231 71288-100_ab05ebc8-a799-4913-b8a5-10c73a101db7 71288-100 HUMAN PRESCRIPTION DRUG Carboplatin Carboplatin INJECTION, SOLUTION INTRAVENOUS 20170619 ANDA ANDA077096 Meitheal Pharmaceuticals Inc. CARBOPLATIN 10 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 71288-101_cb1f3bfc-6a80-4a0f-8859-e0260ecf1050 71288-101 HUMAN PRESCRIPTION DRUG Oxaliplatin Oxaliplatin INJECTION, SOLUTION INTRAVENOUS 20171001 ANDA ANDA207325 Meitheal Pharmaceuticals Inc. OXALIPLATIN 5 mg/mL Platinum-based Drug [EPC],Platinum-containing Compounds [Chemical/Ingredient] N 20181231 71289-100_48eea620-019b-4137-a581-58090a28b389 71289-100 HUMAN OTC DRUG Skin Shield Lanolin LOTION TOPICAL 20170315 OTC MONOGRAPH FINAL part347 4sport D.o.o. LANOLIN 40 g/100mL N 20181231 71290-813_4a116d5a-332b-68b6-e054-00144ff88e88 71290-813 HUMAN OTC DRUG Regenpure Precision MINOXIDIL LIQUID TOPICAL 20170304 ANDA ANDA076239 Salonceuticals, Inc. MINOXIDIL 50 mg/mL N 20181231 71291-0001_4a476852-0951-3269-e054-00144ff88e88 71291-0001 HUMAN OTC DRUG Wild Cultivated Ginseng Purified Pharmacopuncture Wild Cultivated Ginseng LIQUID TOPICAL 20170201 UNAPPROVED DRUG OTHER GEOLIM Pharmaceutical CO., Ltd. (Busan Branch) ASIAN GINSENG 1 g/100mL N 20181231 71293-020_06709b19-7ff6-4775-97d7-9cd72011c2a3 71293-020 HUMAN OTC DRUG Antibacterial Wipes Benzalkonium chloride SWAB TOPICAL 20170316 OTC MONOGRAPH NOT FINAL part333A ERC Wiping Products Inc BENZALKONIUM CHLORIDE .13 g/100g N 20181231 71294-100_14649491-1e29-4ca3-a43c-4da16f2703ea 71294-100 HUMAN OTC DRUG VITA VOLU VOLUME BOOSTER Niacinamide, Adenosine LIQUID TOPICAL 20170302 UNAPPROVED DRUG OTHER B&P COSMETIC, INC. NIACINAMIDE; ADENOSINE 3.6; .07 g/180mL; g/180mL N 20181231 71294-101_5768a2bd-5eac-48fb-88ee-9b749631e734 71294-101 HUMAN OTC DRUG VITA VOLU 101 ESSENCE Niacinamide, Panthenol, Adenosine LIQUID TOPICAL 20170302 UNAPPROVED DRUG OTHER B&P COSMETIC, INC. NIACINAMIDE; PANTHENOL; ADENOSINE 2.4; .12; .04 g/120mL; g/120mL; g/120mL N 20181231 71295-101_65aefa13-820c-4060-80e8-de6aee1b6975 71295-101 HUMAN OTC DRUG DUAL-SHAVE 2 IN 1 BENZOYL PEROXIDE LOTION TOPICAL 20170306 OTC MONOGRAPH FINAL part333D Lamden, Nisan BENZOYL PEROXIDE 5 g/100g N 20181231 71297-500_9342b462-0983-4c9f-9b0e-e998b1061b31 71297-500 HUMAN PRESCRIPTION DRUG PrimSol TRIMETHOPRIM HYDROCHLORIDE SOLUTION ORAL 20170504 NDA NDA074973 Allegis Holdings, LLC TRIMETHOPRIM HYDROCHLORIDE 50 mg/5mL Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 71301-001_638b0628-be39-1c28-e053-2a91aa0aebc3 71301-001 HUMAN OTC DRUG Hot and Cold with Lidocaine Pain Relieving Lidocaine HCl and Menthol CREAM TOPICAL 20170302 OTC MONOGRAPH NOT FINAL part348 Yash Pharmaceuticals LIDOCAINE; MENTHOL .4; .1 g/g; g/g N 20191231 71301-002_4aee9b2d-c66c-4712-e054-00144ff8d46c 71301-002 HUMAN OTC DRUG Lidocaine Pain Relieving Creme Lidocaine Hydrochloride CREAM TOPICAL 20170303 OTC MONOGRAPH NOT FINAL part348 Yash Pharmaceuticals LIDOCAINE HYDROCHLORIDE 4 g/100g N 20181231 71301-003_505b4f4f-ba6e-339d-e054-00144ff88e88 71301-003 HUMAN OTC DRUG Hot and Cold with Lidocaine-RA Pain Relieving Lidocaine HCl and Menthol CREAM TOPICAL 20170525 OTC MONOGRAPH NOT FINAL part348 Yash Pharmaceuticals LIDOCAINE; MENTHOL .4; .1 1/g; 1/g N 20181231 71301-004_51550fa6-2b41-2fd2-e054-00144ff8d46c 71301-004 HUMAN OTC DRUG Pain Relieving Arthritis HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20170526 OTC MONOGRAPH NOT FINAL part348 Yash Pharmceuticals HISTAMINE DIHYDROCHLORIDE .025 g/100g N 20181231 71301-005_5928e978-4e50-55a4-e053-2991aa0afd69 71301-005 HUMAN OTC DRUG Hot and Cold with Lidocaine-Careone Pain Relieving Lidocaine HCl and Menthol CREAM TOPICAL 20170525 OTC MONOGRAPH NOT FINAL part348 Yash Pharmaceuticals LIDOCAINE; MENTHOL .4; .1 1/g; 1/g N 20181231 71301-006_5929523a-a740-d20b-e053-2a91aa0a395f 71301-006 HUMAN OTC DRUG Lidocaine Pain Relieving Creme Lidocaine Hydrochloride CREAM TOPICAL 20170303 OTC MONOGRAPH NOT FINAL part348 Yash Pharmaceuticals LIDOCAINE HYDROCHLORIDE 4 g/100g N 20181231 71303-000_4a2d3b2a-fd4a-0e88-e054-00144ff8d46c 71303-000 HUMAN OTC DRUG Foaming Instant Hand Sanitizer Foaming Instant Hand Sanitizer SOLUTION TOPICAL 20170307 OTC MONOGRAPH NOT FINAL part333A RJ Schinner BENZETHONIUM CHLORIDE 7.56 g/100mL N 20181231 71303-001_4a6a62e5-45a7-64da-e054-00144ff8d46c 71303-001 HUMAN OTC DRUG ezFoam Foaming Alcohol Hand Sanitizer Foaming Hand Sanitizer SOLUTION TOPICAL 20170310 OTC MONOGRAPH NOT FINAL part333A RJ Schinner ALCOHOL 62 mL/100mL N 20181231 71303-002_4999b1e5-a621-4182-e054-00144ff8d46c 71303-002 HUMAN OTC DRUG Foaming E2 Sanitizing Hand benzalkonium chloride SOAP TOPICAL 20170310 OTC MONOGRAPH NOT FINAL part333E RJ Schinner BENZALKONIUM CHLORIDE .003 mg/mL N 20181231 71304-001_60e21b93-f95a-1fdb-e053-2991aa0ac877 71304-001 HUMAN OTC DRUG CU Pain Away Pain Relief MENTHOL CREAM TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part348 Canadian Unique Health Ltd. MENTHOL 12.5 mg/g N 20181231 71305-100_575e5862-5f20-4fec-98eb-658c4538ba66 71305-100 HUMAN OTC DRUG Balanced Satin Finish Foundation SPF 15 Titanium dioxide, Ethylhexyl methoxycinnamate LOTION TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part352 Modern Basic Distributors Ltd TITANIUM DIOXIDE; OCTINOXATE 10; 2.5 g/100mL; g/100mL N 20181231 71305-200_82d61f01-a693-495c-9782-1c65229b3ca8 71305-200 HUMAN OTC DRUG STUDIO BLEND COVER FOUNDATION SPF15 TITANIUM DIOXIDE, ETHYLHEXYL METHOXYCINNAMATE LOTION TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part352 Modern Basic Distributors Ltd TITANIUM DIOXIDE; OCTINOXATE 6.7; 2 mg/mL; mg/mL N 20181231 71310-001_56d07fcb-f24b-6b14-e054-00144ff8d46c 71310-001 HUMAN OTC DRUG Sterile Alcohol Prep Pad Isopropyl alcohol SWAB TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part333A Taizhou Kangping Medical Science And Technology Co., Ltd ISOPROPYL ALCOHOL 70 g/100g N 20181231 71310-002_570fefbb-7860-54d3-e054-00144ff88e88 71310-002 HUMAN OTC DRUG Antiseptic Towelette benzalkonium chloride CLOTH TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part333A Taizhou Kangping Medical Science And Technology Co., Ltd BENZALKONIUM CHLORIDE .13 g/100g N 20181231 71310-100_55ddf0fe-94e2-5fbd-e054-00144ff8d46c 71310-100 HUMAN OTC DRUG ANTISEPTIC WIPE benzalkonium chloride CLOTH TOPICAL 20170803 OTC MONOGRAPH NOT FINAL part333A Taizhou Kangping Medical Science And Technology Co., Ltd BENZALKONIUM CHLORIDE .133 g/100g N 20181231 71310-151_544fafba-1ff6-34d2-e054-00144ff8d46c 71310-151 HUMAN OTC DRUG STERILE ALCOHOL PREP PADS isopropyl alcohol swab SWAB TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part333A Taizhou Kangping Medical Science And Technology Co., Ltd ISOPROPYL ALCOHOL .7 mL/mL N 20181231 71310-152_544fafba-2046-34d2-e054-00144ff8d46c 71310-152 HUMAN OTC DRUG STERILE ALCOHOL PREP PADS isopropyl alcohol swab SWAB TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part333A Taizhou Kangping Medical Science And Technology Co., Ltd ISOPROPYL ALCOHOL .7 mL/mL N 20181231 71310-153_51910777-d00c-063a-e054-00144ff88e88 71310-153 HUMAN OTC DRUG STERILE ALCOHOL PREP PADS Isopropyl alcohol swab SWAB TOPICAL 20170609 OTC MONOGRAPH NOT FINAL part333A Taizhou Kangping Medical Science And Technology Co., Ltd ISOPROPYL ALCOHOL .7 mL/mL N 20181231 71310-170_4da0f791-ebe0-4476-e054-00144ff8d46c 71310-170 HUMAN OTC DRUG Isopropyl alcohol swab PARA-AID STERILE ALCOHOL PREP PADS SWAB TOPICAL 20170420 OTC MONOGRAPH NOT FINAL part333A Taizhou Kangping Medical Science And Technology Co., Ltd ISOPROPYL ALCOHOL 70 g/100g N 20181231 71310-202_6479cba9-cdfd-769c-e053-2a91aa0a6e0c 71310-202 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol PATCH TOPICAL 20180130 OTC MONOGRAPH NOT FINAL part333A Taizhou Kangping Medical Science And Technology Co., Ltd. ISOPROPYL ALCOHOL 70 g/100g N 20191231 71310-345_4a40e307-8c36-675f-e054-00144ff88e88 71310-345 HUMAN OTC DRUG MEDICAL BZK ANTISEPTIC WIPES Benzalkonium chloride cloth PATCH TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part333A Taizhou Kangping Medical Science And Technology Co., Ltd BENZALKONIUM CHLORIDE .13 g/100g N 20181231 71310-555_551a0cf3-0c25-16b6-e054-00144ff88e88 71310-555 HUMAN OTC DRUG STERILE ALCOHOL PREP PADS Isopropyl alcohol swab SWAB TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part333A Taizhou Kangping Medical Science And Technology Co., Ltd ISOPROPYL ALCOHOL .7 mL/mL N 20181231 71310-556_55191547-afe9-5e87-e054-00144ff88e88 71310-556 HUMAN OTC DRUG ANTISEPTIC HAND WIPE benzalkonium chloride PATCH TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part333A Taizhou Kangping Medical Science And Technology Co., Ltd BENZALKONIUM CHLORIDE .13 g/100g N 20181231 71310-980_4a3dae8a-2dcf-5da3-e054-00144ff8d46c 71310-980 HUMAN OTC DRUG STERILE ALCOHOL Isopropyl alcohol swab PATCH TOPICAL 20170308 OTC MONOGRAPH NOT FINAL part333A Taizhou Kangping Medical Science And Technology Co., Ltd ISOPROPYL ALCOHOL .7 mL/mL N 20181231 71315-100_511260a9-4bf7-1ad0-e054-00144ff88e88 71315-100 HUMAN OTC DRUG Aplaus Hand and Skin Sanitizer Benzalkonium chloride SPRAY TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part333A Katan Technologies USA, LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 71315-200_5115c3a5-4a78-65ce-e054-00144ff88e88 71315-200 HUMAN OTC DRUG Biospada Plus Hand and Skin Sanitizer Benzalkonium chloride SPRAY TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part333A Katan Technologies USA, LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 71315-300_516b7a9e-0eb0-21d9-e054-00144ff8d46c 71315-300 HUMAN OTC DRUG Ovation Hand and Skin Sanitizer Benzalkonium chloride SPRAY TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part333A Katan Technologies USA, LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 71315-600_516b8c3e-2b77-6669-e054-00144ff88e88 71315-600 HUMAN OTC DRUG Arridus Hand and Skin Sanitizer Benzalkonium chloride SPRAY TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part333A Katan Technologies USA, LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 71317-815_4a9d2992-071a-0f20-e054-00144ff88e88 71317-815 HUMAN OTC DRUG Goldies Pain Off CAMPHOR CREAM TOPICAL 20170311 OTC MONOGRAPH NOT FINAL part348 Goldie's Biohealth, LLC CAMPHOR (SYNTHETIC) 50 mg/mL N 20181231 71318-001_5296b5d8-0200-5ce0-e054-00144ff88e88 71318-001 HUMAN OTC DRUG Hot and Cold Lidocaine with Menthol Patch Pain Relief lidocaine and menthol PATCH TOPICAL 20170303 OTC MONOGRAPH NOT FINAL part348 DR SABHARWAL'S WOUND CARE LIDOCAINE; MENTHOL 40; 10 mg/1; mg/1 N 20181231 71318-002_529693d8-b5c5-57c6-e054-00144ff88e88 71318-002 HUMAN OTC DRUG Maximum strength Lidocaine Patch Lidocaine PATCH TOPICAL 20170622 OTC MONOGRAPH NOT FINAL part348 DR SABHARWAL'S WOUND CARE LIDOCAINE 40 mg/1 N 20181231 71319-009_f9e88f4d-40aa-4f06-8d01-0a87ce3d7b75 71319-009 HUMAN OTC DRUG Perfect Purity Oil Free Acne Wash Salicyclic Acid RINSE TOPICAL 20170313 OTC MONOGRAPH FINAL part358H 9338-9641 Quebec Inc SALICYLIC ACID 2 g/100g N 20181231 71321-100_6c682180-108d-498d-b8b2-7d505138d358 71321-100 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20170726 OTC MONOGRAPH NOT FINAL part343 Brandywine Pharmaceuticals, LLC ACETAMINOPHEN 325 mg/1 N 20181231 71322-010_6ef0cc3c-64df-45ae-a860-04dc34c5d38d 71322-010 HUMAN OTC DRUG SONATURAL FOR MEN STAY YOUNG ALL IN ONE FLUID Dimethicone CREAM TOPICAL 20170302 OTC MONOGRAPH FINAL part347 Sonatural Global Co.,Ltd DIMETHICONE 5 g/100mL N 20181231 71322-020_8a39577c-e8ae-4a1a-838b-a6c1ab7d7c08 71322-020 HUMAN OTC DRUG SONATURAL FACIAL DESIGN PINK MUD MASK KAOLIN PATCH TOPICAL 20170302 UNAPPROVED DRUG OTHER Sonatural Global Co.,Ltd KAOLIN 2.8 g/14g N 20181231 71322-030_67eb0b91-5b2c-4768-b8aa-73ba06f95c4b 71322-030 HUMAN OTC DRUG SONATURAL DEEP MOISTURE CERAFOCUS ESSENTIAL FIRST ESSENCE Dimethicone LIQUID TOPICAL 20170302 OTC MONOGRAPH FINAL part347 Sonatural Global Co.,Ltd DIMETHICONE 5.4 g/135mL N 20181231 71322-040_309930d3-71b5-46d8-b0b2-12890906571d 71322-040 HUMAN OTC DRUG SONATURAL HIGH WATER DRAW SUPER HYDRA BALM Dimethicone CREAM TOPICAL 20170302 OTC MONOGRAPH FINAL part347 Sonatural Global Co.,Ltd DIMETHICONE 1.5 g/75mL N 20181231 71322-050_0af76599-7865-4b9a-b6f7-61876a5a4f07 71322-050 HUMAN OTC DRUG SONATURAL POW DER4ROOM MAKEUP HOLDING FINISH POW DER FIXER BRIGHT PINK Dimethicone POWDER TOPICAL 20170302 OTC MONOGRAPH FINAL part347 Sonatural Global Co.,Ltd DIMETHICONE .12 g/6g N 20181231 71322-060_55608bfc-b371-40d0-884e-5453d6b2cd9a 71322-060 HUMAN OTC DRUG SONATURAL POW DER4ROOM MAKEUP HOLDING FINISH POW DER FIXER NATURAL YELLOW Dimethicone POWDER TOPICAL 20170302 OTC MONOGRAPH FINAL part347 Sonatural Global Co.,Ltd DIMETHICONE .06 g/6g N 20181231 71322-070_8eef6531-c961-44f1-852b-e50772e9c08e 71322-070 HUMAN OTC DRUG SONATURAL POW DER4ROOM SMUDGING ZERO REMOVER Dimethicone STICK TOPICAL 20170302 OTC MONOGRAPH FINAL part347 Sonatural Global Co.,Ltd DIMETHICONE .18 g/1.5g N 20181231 71322-080_01be7f50-6de2-4823-a626-9b1c0ad7ca22 71322-080 HUMAN OTC DRUG SONATURAL CENTELLA FACIAL THIN MASK Niacinamide PATCH TOPICAL 20170302 UNAPPROVED DRUG OTHER Sonatural Global Co.,Ltd NIACINAMIDE .46 g/23mL N 20181231 71322-090_34b81c19-dd38-416b-af86-54bcc3194c68 71322-090 HUMAN OTC DRUG SONATURAL DEEP MOISTURE CERAFOCUS ENHANCE CERAMIDE Ceramide 3 CREAM TOPICAL 20170302 UNAPPROVED DRUG OTHER Sonatural Global Co.,Ltd CERAMIDE 3 1.5 g/50mL N 20181231 71322-100_73053335-ccf8-4c35-8805-ba0a35bcfa6e 71322-100 HUMAN OTC DRUG SONATURAL POW DER4ROOM COVER FIXING CUSHION 21.5 Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20170302 OTC MONOGRAPH NOT FINAL part352 Sonatural Global Co.,Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 71322-110_7fcda679-b7fa-4c17-ae3d-028d2841d4c6 71322-110 HUMAN OTC DRUG SONATURAL POW DER4ROOM COVER FIXING CUSHION 23.5 Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20170302 OTC MONOGRAPH NOT FINAL part352 Sonatural Global Co.,Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 71322-120_ff56f8a1-aed0-4ce5-bf22-f9df2ec398d4 71322-120 HUMAN OTC DRUG SONATURAL POW DER4ROOM FIXING IT FULL COVER NEUTRAL BEIGE Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170302 OTC MONOGRAPH NOT FINAL part352 Sonatural Global Co.,Ltd TITANIUM DIOXIDE; ZINC OXIDE 9.04; 2.83 g/45g; g/45g N 20181231 71322-130_01d78c71-afe0-42a5-9e98-62c7b87cc1c2 71322-130 HUMAN OTC DRUG SONATURAL POW DER4ROOM FIXING IT FULL COVER VANILLA BEIGE Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170302 OTC MONOGRAPH NOT FINAL part352 Sonatural Global Co.,Ltd TITANIUM DIOXIDE; ZINC OXIDE 9.04; 2.83 g/45g; g/45g N 20181231 71322-140_ee3937d7-4b54-4177-9720-62fbbc89ae84 71322-140 HUMAN OTC DRUG SONATURAL FACIAL DESIGN DEEP BLACK CLAY MASK Kaolin PATCH TOPICAL 20171001 UNAPPROVED DRUG OTHER Sonatural Global Co.,Ltd KAOLIN 3.5 g/14g N 20181231 71322-150_aa98387d-e12b-4fb5-ab24-7081701e4feb 71322-150 HUMAN OTC DRUG SONATURAL THE PURE PORE TENSING CARBONIC BUBBLE POP CLAY MASK Kaolin CREAM TOPICAL 20171001 UNAPPROVED DRUG OTHER Sonatural Global Co.,Ltd KAOLIN 45.5 g/130g N 20181231 71322-160_4e9c3d0e-3a54-466d-a518-3b241ba62019 71322-160 HUMAN OTC DRUG SONATURAL ALL KILL BLACKHEAD CLEAR Silica STICK TOPICAL 20171001 UNAPPROVED DRUG OTHER Sonatural Global Co.,Ltd SILICON DIOXIDE .88 g/11g N 20181231 71323-101_7a9eefa7-6163-46ef-88c3-871c1ba7d2ac 71323-101 HUMAN OTC DRUG ICY COLD COOL PAIN RELIEVING MENTHOL, CAMPHOR GEL TOPICAL 20170322 OTC MONOGRAPH NOT FINAL part348 COMPASS HEALTH BRANDS CORP. MENTHOL; CAMPHOR (SYNTHETIC) 3.9; .4 g/100mL; g/100mL N 20181231 71324-0015_4bb170a3-5b73-4905-e054-00144ff88e88 71324-0015 HUMAN OTC DRUG HERBAL IRON BRILLIANT PERFORMANCE FOR BRIGHTENING AND WRINKLE FREE Ginsenosides, Adenosine KIT TOPICAL 20170327 UNAPPROVED DRUG OTHER BTGIN CO.,LTD N 20181231 71325-0001_4b1305eb-2107-0af9-e054-00144ff8d46c 71325-0001 HUMAN OTC DRUG MYSTIC FOREST TOOTH SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20170201 OTC MONOGRAPH FINAL part355 RUCIPELLOKOREA INC. SODIUM MONOFLUOROPHOSPHATE .4 g/100g N 20181231 71325-0002_578fe0a3-b534-6dfb-e053-2a91aa0a3934 71325-0002 HUMAN OTC DRUG MITNTY OCEAN SALT TOOTH SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20170825 OTC MONOGRAPH FINAL part355 RUCIPELLOKOREA INC. SODIUM MONOFLUOROPHOSPHATE .45 g/100g N 20181231 71325-0003_579cf875-56c9-7917-e053-2991aa0a4eba 71325-0003 HUMAN OTC DRUG TROPICAL OCEAN TOOTH SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20170825 OTC MONOGRAPH FINAL part355 RUCIPELLOKOREA INC. SODIUM MONOFLUOROPHOSPHATE .4 g/100g N 20181231 71325-0004_5c7e6a13-c50d-ae49-e053-2a91aa0a342b 71325-0004 HUMAN OTC DRUG ROOISLAND TOOTH hydrated silica PASTE, DENTIFRICE DENTAL 20171027 UNAPPROVED DRUG OTHER RUCIPELLOKOREA INC. HYDRATED SILICA 6.11 g/100g N 20181231 71326-101_f64a0928-eeb7-4c4e-a6f8-10d9a677895b 71326-101 HUMAN OTC DRUG RHINO LONG POWER MENTHOL, PANAX GINSENG, GINKGO BILOBA CREAM TOPICAL 20170406 UNAPPROVED HOMEOPATHIC HOT PRODUCTIONS AND VERTRIEBS GMBH MENTHOL; ASIAN GINSENG; GINKGO 1; 1; 1 g/100mL; g/100mL; g/100mL N 20191231 71326-201_60f7c96d-9440-4e60-8d4c-38c6561963f1 71326-201 HUMAN OTC DRUG RHINO LONG POWER MENTHOL, GINKGO BILOBA SPRAY TOPICAL 20170406 UNAPPROVED HOMEOPATHIC HOT PRODUCTIONS AND VERTRIEBS GMBH MENTHOL; GINKGO 1; 1 g/100mL; g/100mL N 20191231 71327-001_c5430840-9681-4ad0-8f58-8a72fd92d03b 71327-001 HUMAN OTC DRUG AC7 ACNE SERUM GEL TOPICAL 20170320 UNAPPROVED DRUG OTHER MICELL KOREA CO.,LTD SALICYLIC ACID .000001 g/10mL N 20181231 71327-002_358c231f-ce40-4637-9256-dd0cde49d223 71327-002 HUMAN OTC DRUG Cell Power Boosting Essence Allantoin CREAM TOPICAL 20170320 UNAPPROVED DRUG OTHER MICELL KOREA CO.,LTD ALLANTOIN; PYRIDOXINE HYDROCHLORIDE .000021; .0000021 g/210mL; g/210mL N 20181231 71327-003_8199b568-5529-4e42-aad9-6f41b3d9bef4 71327-003 HUMAN OTC DRUG Energy Booster Essence Allantoin CREAM TOPICAL 20170320 UNAPPROVED DRUG OTHER MICELL KOREA CO.,LTD ALLANTOIN; PYRIDOXINE HYDROCHLORIDE .000005; .0000005 g/50mL; g/50mL N 20181231 71327-004_8e646b4b-e7e4-4a0f-8259-a040cdf55e78 71327-004 HUMAN OTC DRUG Medi Wrinkle Cream Dimethicone CREAM TOPICAL 20170320 UNAPPROVED DRUG OTHER MICELL KOREA CO.,LTD DIMETHICONE; ALLANTOIN .0021; .000021 g/210mL; g/210mL N 20181231 71327-005_664358a4-8ed9-4068-bd74-1a52582f4e0a 71327-005 HUMAN OTC DRUG Medi Wrinkle Serum Allantoin serum CREAM TOPICAL 20170320 UNAPPROVED DRUG OTHER MICELL KOREA CO.,LTD ALLANTOIN; PYRIDOXINE HYDROCHLORIDE .000021; .0000021 g/210mL; g/210mL N 20181231 71327-006_99e0673a-2a84-42de-989f-217c8c762e70 71327-006 HUMAN OTC DRUG Perfect Wrinkle Serum Allantoin Serum CREAM TOPICAL 20170320 UNAPPROVED DRUG OTHER MICELL KOREA CO.,LTD ALLANTOIN; PYRIDOXINE HYDROCHLORIDE .000005; .0000005 g/50mL; g/50mL N 20181231 71327-007_372dfe81-40e6-4708-ab5a-38afb7f7b0ea 71327-007 HUMAN OTC DRUG Snow White Ampoule Allantoin CREAM TOPICAL 20170320 UNAPPROVED DRUG OTHER MICELL KOREA CO.,LTD ALLANTOIN; PYRIDOXINE HYDROCHLORIDE .000004; .0000004 g/40mL; g/40mL N 20181231 71327-008_b84ea3c8-4372-4fe3-b408-db771650787b 71327-008 HUMAN OTC DRUG T2 SERUM Allantoin CREAM TOPICAL 20170320 UNAPPROVED DRUG OTHER MICELL KOREA CO.,LTD ALLANTOIN .000003 g/30mL N 20181231 71328-817_4acb3808-254d-16d0-e054-00144ff8d46c 71328-817 HUMAN OTC DRUG CliXit Acne Eraser SULFUR LOTION TOPICAL 20170315 OTC MONOGRAPH FINAL part333D Clixit, LLC SULFUR 100 mg/mL N 20181231 71330-101_6217d57e-e510-47bc-9df7-b35624a42eea 71330-101 HUMAN OTC DRUG Whole Body Organic Sunscreen Zinc Oxide LOTION TOPICAL 20170401 OTC MONOGRAPH FINAL part352 ALTEYA ORGANICS OOD ZINC OXIDE 20 g/100mL N 20181231 71330-102_8efcf6e6-774e-4ed1-b484-f6d37518a293 71330-102 HUMAN OTC DRUG KIDS AND BABY ORGANIC SUNSCREEN Zinc Oxide LOTION TOPICAL 20170401 OTC MONOGRAPH FINAL part352 ALTEYA ORGANICS OOD ZINC OXIDE 20 g/100mL N 20181231 71330-103_4d6ab4c3-c1e4-4767-b93c-e8e41e79e567 71330-103 HUMAN OTC DRUG ORGANIC ROSE FACE SUNSCREEN Zinc Oxide LOTION TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 ALTEYA ORGANICS OOD ZINC OXIDE 20 g/100mL N 20181231 71330-104_a20d2853-edc0-45f0-8191-b9cf300b08f5 71330-104 HUMAN OTC DRUG BIO DAMASCENA ROSE OTTO FACE SUNSCREEN Zinc Oxide LOTION TOPICAL 20170401 OTC MONOGRAPH FINAL part352 ALTEYA ORGANICS OOD ZINC OXIDE 18 g/100mL N 20181231 71330-105_9ac8f9ea-287c-4aaf-9757-09214a832574 71330-105 HUMAN OTC DRUG ORGANIC ROSE LIP BALM SUNSCREEN Zinc Oxide LIPSTICK TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 ALTEYA ORGANICS OOD ZINC OXIDE 10 g/100g N 20181231 71330-201_4ddb21bf-6c1e-4358-b952-06796bf58d1c 71330-201 HUMAN OTC DRUG Organic Diaper Rash Cream Zinc Oxide CREAM TOPICAL 20170916 OTC MONOGRAPH FINAL part347 ALTEYA ORGANICS OOD ZINC OXIDE 17 g/100mL N 20181231 71331-101_4a64dc7e-543c-51c7-e054-00144ff8d46c 71331-101 HUMAN OTC DRUG Salicylic Acid Salicylic Acid SHAMPOO TOPICAL 20170601 UNAPPROVED DRUG OTHER Orange Lab SALICYLIC ACID 2 g/100g N 20181231 71335-0001_f6cd2bd7-3666-492d-8dd1-e3f3bce0a03a 71335-0001 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 19970829 ANDA ANDA074979 Bryant Ranch Prepack CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 71335-0002_d651e773-3a3d-456a-80c6-e0a66d0e2101 71335-0002 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20110714 ANDA ANDA075580 Bryant Ranch Prepack DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 71335-0003_09fc853d-6ae2-4f0f-9aaf-320f9fb64020 71335-0003 HUMAN PRESCRIPTION DRUG tizanidine tizanidine TABLET ORAL 20040116 ANDA ANDA076533 Bryant Ranch Prepack TIZANIDINE HYDROCHLORIDE 2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20181231 71335-0004_bfd00cba-e8cc-4817-b1d5-0078e331befc 71335-0004 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Bryant Ranch Prepack ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 71335-0005_c476c9b7-fb15-420a-b09f-c9c303f1d69e 71335-0005 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 Bryant Ranch Prepack ESZOPICLONE 1 mg/1 CIV N 20191231 71335-0006_6fd9ec85-475c-4530-99d4-e6a3f7b627ce 71335-0006 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE (SR) Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160725 ANDA ANDA206674 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 71335-0007_3f08e758-023c-483f-9da3-7e11421228a4 71335-0007 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161215 ANDA ANDA202557 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20181231 71335-0008_94438b89-3a73-4b77-b6c8-900bd30e0db2 71335-0008 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111001 ANDA ANDA079163 Bryant Ranch Prepack DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20181231 71335-0009_e635be73-dc27-44ad-86c8-aa849617e328 71335-0009 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended-Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 20151001 ANDA ANDA074984 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 71335-0010_01a44a30-d474-4b16-b1e6-ca29b2284155 71335-0010 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Bryant Ranch Prepack LAMOTRIGINE 200 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 71335-0011_d620d857-0e73-459f-b236-80ed5ab8d378 71335-0011 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 71335-0012_73e9790c-0c0d-44e8-8328-e129d5086dcd 71335-0012 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 71335-0013_f2cdac9a-393f-462b-a0fa-7028008c04ac 71335-0013 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 71335-0014_b0b57162-11f5-4654-a45b-42164674295c 71335-0014 HUMAN PRESCRIPTION DRUG Naltrexone Hydrochloride Naltrexone Hydrochloride TABLET, FILM COATED ORAL 20120118 ANDA ANDA091205 Bryant Ranch Prepack NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 71335-0015_60890d53-7f42-4bc0-90ad-ea9d47906fce 71335-0015 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 Bryant Ranch Prepack LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 71335-0016_d51f1840-17e3-48b5-a75f-89d5ec246ad5 71335-0016 HUMAN PRESCRIPTION DRUG Bumetanide Bumetanide TABLET ORAL 20151015 NDA AUTHORIZED GENERIC NDA018225 Bryant Ranch Prepack BUMETANIDE 1 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20181231 71335-0017_61cee413-9f12-4c50-9d36-259262e52568 71335-0017 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20120725 ANDA ANDA065489 Bryant Ranch Prepack CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 71335-0018_793c7684-4a23-4bae-982c-93d4a48d5f69 71335-0018 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil Olmesartan Medoxomil TABLET, FILM COATED ORAL 20170424 ANDA ANDA091079 Bryant Ranch Prepack OLMESARTAN MEDOXOMIL 20 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 71335-0019_5fb9fc2e-16f2-4c49-8e38-98d3f2a373ef 71335-0019 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20031125 ANDA ANDA075932 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 71335-0020_ec00df7a-ba2e-46d4-9b65-03906a9cd6bb 71335-0020 HUMAN PRESCRIPTION DRUG Glycopyrrolate Glycopyrrolate TABLET ORAL 20160318 ANDA ANDA090195 Bryant Ranch Prepack GLYCOPYRROLATE 2 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 71335-0021_688f8359-fe64-433a-8490-028c9231d3c0 71335-0021 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20100524 ANDA ANDA077135 Bryant Ranch Prepack VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 71335-0022_5d3fb114-5e0e-4d2d-92c7-432194ab4fba 71335-0022 HUMAN PRESCRIPTION DRUG Clonazepam clonazepam TABLET ORAL 20110603 ANDA ANDA077147 Bryant Ranch Prepack CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 71335-0023_7ba4e0bd-19c3-4f8d-b6d4-d0d69022236f 71335-0023 HUMAN PRESCRIPTION DRUG Anastrozole Anastrozole TABLET, FILM COATED ORAL 20120531 ANDA ANDA200654 Bryant Ranch Prepack ANASTROZOLE 1 mg/1 Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA] N 20181231 71335-0024_66ee56c7-6808-441f-9f98-5368eec81156 71335-0024 HUMAN PRESCRIPTION DRUG Nitrofurantion Nitrofurantion CAPSULE ORAL 20160415 ANDA ANDA201722 Bryant Ranch Prepack NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 71335-0025_6fd9ec85-475c-4530-99d4-e6a3f7b627ce 71335-0025 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE (SR) Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20160725 ANDA ANDA206674 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 71335-0026_b49839f6-bdb5-47b4-87db-8cc74e32ff96 71335-0026 HUMAN OTC DRUG SENNA LAXATIVE Sennosides TABLET ORAL 20160201 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack SENNOSIDES 8.6 mg/1 N 20181231 71335-0027_eb993e50-3240-42af-8eb0-8a1a228cf812 71335-0027 HUMAN PRESCRIPTION DRUG RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA078964 Bryant Ranch Prepack RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 71335-0028_60c1bbfd-c630-419b-b297-d76a2e6d4e81 71335-0028 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20071227 ANDA ANDA077946 Bryant Ranch Prepack CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20181231 71335-0029_bb50e9e5-b146-4eb2-9438-5c8c954b777d 71335-0029 HUMAN PRESCRIPTION DRUG Verapamil Hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140407 ANDA ANDA074587 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 71335-0030_2de6c8cd-c1d8-40ce-b35e-b4cec163957f 71335-0030 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120217 ANDA ANDA202248 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 71335-0031_b81aecb5-f674-4ce9-8d16-0daf4101b568 71335-0031 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20150810 ANDA ANDA202765 Bryant Ranch Prepack BENZONATATE 200 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 71335-0032_2f735555-d358-4a9c-8bfe-76019ef81ef5 71335-0032 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20141118 ANDA ANDA040148 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20181231 71335-0033_9f21156e-8ddc-49e2-aa22-9187554ee9b4 71335-0033 HUMAN PRESCRIPTION DRUG MONTELUKAST SODIUM MONTELUKAST SODIUM TABLET, CHEWABLE ORAL 20150813 ANDA ANDA203328 Bryant Ranch Prepack MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 71335-0034_84feb30f-fe0e-4a23-b370-2796d943f38f 71335-0034 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Bryant Ranch Prepack CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 71335-0035_dc2519b1-9430-4708-be7c-05e146d4f796 71335-0035 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071258 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 71335-0036_c321df31-9181-4387-a1c7-4f6fd47e8541 71335-0036 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 Bryant Ranch Prepack GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 71335-0037_df86c376-a5ae-4404-a44c-ddeec30c8904 71335-0037 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100607 ANDA ANDA075522 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 71335-0038_3b5d41a2-c5a4-42b6-b42a-65b39aa1c69e 71335-0038 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Bryant Ranch Prepack OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0039_c321df31-9181-4387-a1c7-4f6fd47e8541 71335-0039 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20110718 ANDA ANDA074550 Bryant Ranch Prepack GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 71335-0040_d85f76b2-1b4b-4e13-a660-89dcc495215b 71335-0040 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 100 mg/1 Tricyclic Antidepressant [EPC] N 20191231 71335-0041_d0cb32ba-6cd0-42a4-ac80-ada2b5802b13 71335-0041 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 71335-0042_2238b362-057c-4698-9225-344e1d2e9b9f 71335-0042 HUMAN PRESCRIPTION DRUG Ranitidine Immediate release Ranitidine TABLET ORAL 20160829 ANDA ANDA205512 Bryant Ranch Prepack RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 71335-0043_0376b25d-021a-4148-baa9-9bec22d578b1 71335-0043 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 Bryant Ranch Prepack LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 71335-0044_01a44a30-d474-4b16-b1e6-ca29b2284155 71335-0044 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Bryant Ranch Prepack LAMOTRIGINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 71335-0045_1e82e3e7-b968-4d20-8bcf-319affb2409f 71335-0045 HUMAN PRESCRIPTION DRUG Lovastatin Lovastatin TABLET ORAL 20021125 ANDA ANDA075991 Bryant Ranch Prepack LOVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 71335-0046_2dd14886-7dc7-4504-8e46-82335679e8bc 71335-0046 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20150402 ANDA ANDA065062 Bryant Ranch Prepack MINOCYCLINE HYDROCHLORIDE 100 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 71335-0047_2b83ac9d-fd3e-4e1c-85b4-510650a25764 71335-0047 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Bryant Ranch Prepack TOPIRAMATE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0048_a9f6bde2-54db-49bd-909c-c522bd667d1d 71335-0048 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20130531 ANDA ANDA090843 Bryant Ranch Prepack LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71335-0049_0483398e-50d7-49a7-a938-372448f0ef9b 71335-0049 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride ER Diethylpropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20111024 ANDA ANDA091680 Bryant Ranch Prepack DIETHYLPROPION HYDROCHLORIDE 75 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 71335-0050_e3dd5b69-5c0f-488c-97ae-981c8dc71d2a 71335-0050 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Bryant Ranch Prepack CLONIDINE HYDROCHLORIDE .3 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 71335-0051_e88dd8f5-d397-4d12-b8fb-a8261342b7de 71335-0051 HUMAN PRESCRIPTION DRUG GEMFIBROZIL GEMFIBROZIL TABLET ORAL 20170323 ANDA ANDA078012 Bryant Ranch Prepack GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 71335-0053_ad282a60-6c8a-4a86-9982-8df78d9489ff 71335-0053 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170602 ANDA ANDA203512 Bryant Ranch Prepack SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20191231 71335-0054_930c45c1-a7d3-4eef-809d-7537c1e7945d 71335-0054 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20150601 ANDA ANDA081297 Bryant Ranch Prepack BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 71335-0055_e87ee19c-bc64-46a2-8727-8edd349d047b 71335-0055 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 19851224 NDA AUTHORIZED GENERIC NDA018998 Bryant Ranch Prepack ENALAPRIL MALEATE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 71335-0056_e9d1604b-0bdf-43b6-8566-244e2300d3d7 71335-0056 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170216 ANDA ANDA207068 Bryant Ranch Prepack PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 71335-0057_01a44a30-d474-4b16-b1e6-ca29b2284155 71335-0057 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Bryant Ranch Prepack LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 71335-0058_a71d85f8-8963-4712-99f8-bc31fe4fa32c 71335-0058 HUMAN PRESCRIPTION DRUG Lansoprazole lansoprazole CAPSULE, DELAYED RELEASE ORAL 20101015 ANDA ANDA091269 Bryant Ranch Prepack LANSOPRAZOLE 15 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20181231 71335-0059_e9d1604b-0bdf-43b6-8566-244e2300d3d7 71335-0059 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170216 ANDA ANDA207068 Bryant Ranch Prepack PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 71335-0060_007257de-6232-4ccb-943f-59e81c164a61 71335-0060 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA076194 Bryant Ranch Prepack LISINOPRIL; HYDROCHLOROTHIAZIDE 10; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 71335-0061_62e81f50-a93d-4058-9c2d-5b1eb15a6c37 71335-0061 HUMAN OTC DRUG Allergy Time Chlorpheniramine Maleate TABLET ORAL 20110208 OTC MONOGRAPH FINAL part341 Bryant Ranch Prepack CHLORPHENIRAMINE MALEATE 4 mg/1 N 20181231 71335-0062_f9edc3b5-7db6-49a1-b6bf-0c19b499a02f 71335-0062 HUMAN PRESCRIPTION DRUG Ergocalciferol Ergocalciferol CAPSULE, LIQUID FILLED ORAL 20160615 ANDA ANDA080704 Bryant Ranch Prepack ERGOCALCIFEROL 1.25 mg/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20181231 71335-0063_390c1980-1096-4b7b-bf07-8cf6a320cbd7 71335-0063 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 71335-0064_2bded2bf-20bd-470e-8e02-a688cdba0e85 71335-0064 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 71335-0065_0e1a38e0-44a7-4c89-9941-bbb7c2897144 71335-0065 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 19950405 ANDA ANDA074132 Bryant Ranch Prepack NORTRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20181231 71335-0066_10dfd97d-dc31-4824-b537-39379137b3d2 71335-0066 HUMAN PRESCRIPTION DRUG Tetracycline Hydrochloride Tetracycline Hydrochloride CAPSULE ORAL 19880812 ANDA ANDA062752 Bryant Ranch Prepack TETRACYCLINE HYDROCHLORIDE 500 mg/1 Tetracycline-class Antimicrobial [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 71335-0067_b463956c-33f9-4a03-958d-d4359a2c3096 71335-0067 HUMAN PRESCRIPTION DRUG hydrochlorothiazide hydrochlorothiazide CAPSULE ORAL 20100315 ANDA ANDA090510 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 71335-0068_aaac0c9b-e4f9-4610-b741-09b72494d3c7 71335-0068 HUMAN PRESCRIPTION DRUG Rosuvastatin Calcium Rosuvastatin Calcium TABLET, FILM COATED ORAL 20160719 ANDA ANDA079170 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 71335-0069_ed3e19f5-01dd-4e31-b64e-ef4e589190f9 71335-0069 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Bryant Ranch Prepack GLYBURIDE 2.5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 71335-0070_cd36b0f9-5d42-47de-9821-fb07027f2ccb 71335-0070 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Bryant Ranch Prepack CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 71335-0071_93bf0840-70e8-4647-9595-c80e15f9edfe 71335-0071 HUMAN PRESCRIPTION DRUG Irbesartan Irbesartan TABLET ORAL 20160613 ANDA ANDA203071 Bryant Ranch Prepack IRBESARTAN 300 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 71335-0072_5c8dc261-1564-49f4-892e-39df977c102a 71335-0072 HUMAN PRESCRIPTION DRUG Doxepin Hydrochloride Doxepin Hydrochloride CAPSULE ORAL 20170628 ANDA ANDA207482 Bryant Ranch Prepack DOXEPIN HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20181231 71335-0073_82a03360-4484-49e0-8340-06835cf78d97 71335-0073 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20160629 ANDA ANDA090705 Bryant Ranch Prepack GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71335-0074_0d45b028-186a-4a07-91cd-3b0cee592ec4 71335-0074 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 Bryant Ranch Prepack PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20191231 71335-0075_60890d53-7f42-4bc0-90ad-ea9d47906fce 71335-0075 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 Bryant Ranch Prepack LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 71335-0076_824d4630-c311-467a-9847-0a6e3ebddd96 71335-0076 HUMAN OTC DRUG Good Sense Fiber Laxative Calcium polycarbophil TABLET, FILM COATED ORAL 19970801 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack CALCIUM POLYCARBOPHIL 625 mg/1 N 20181231 71335-0077_296918ad-9c34-4ee2-8fdf-669d57d5b06a 71335-0077 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088160 Bryant Ranch Prepack DEXAMETHASONE .75 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 71335-0078_d620d857-0e73-459f-b236-80ed5ab8d378 71335-0078 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 71335-0079_3ab48670-fc13-47a3-b5b9-04e87c4f2e23 71335-0079 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20101014 ANDA ANDA078179 Bryant Ranch Prepack ZOLPIDEM TARTRATE 6.25 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20191231 71335-0080_86aaa353-bebf-4d31-b01e-cefbc0eeb1dc 71335-0080 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel Bisulfate TABLET, FILM COATED ORAL 20120517 ANDA ANDA090540 Bryant Ranch Prepack CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 71335-0081_ee4d7ce5-9fc1-4e5d-934e-9f15f097e489 71335-0081 HUMAN OTC DRUG Banophen diphenhydramine hcl CAPSULE ORAL 20091102 OTC MONOGRAPH NOT FINAL part348 Bryant Ranch Prepack DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 71335-0082_dd3463e1-7d31-41ea-ab76-ebc29bd6ccd1 71335-0082 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070218 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 20 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 71335-0083_201efa65-c7b2-4b79-bf30-7256ec49a528 71335-0083 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Bryant Ranch Prepack NORTRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 71335-0084_f6f8b042-4d86-4099-a6c2-3fbd39042a58 71335-0084 HUMAN OTC DRUG Bisacodyl Enteric Coated Bisacodyl TABLET, COATED ORAL 20081024 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack BISACODYL 5 mg/1 N 20181231 71335-0085_090aae59-c8c6-4c99-b026-ff662df19189 71335-0085 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 71335-0086_c7bca691-6637-4330-b837-9d3a7d3dfbfa 71335-0086 HUMAN PRESCRIPTION DRUG Nizatidine Nizatidine CAPSULE ORAL 20110715 ANDA ANDA090618 Bryant Ranch Prepack NIZATIDINE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 71335-0088_9eb3b1ea-da83-4f85-9b42-76ff4ade6a80 71335-0088 HUMAN PRESCRIPTION DRUG Pioglitazone Pioglitazone TABLET ORAL 20130214 ANDA ANDA202467 Bryant Ranch Prepack PIOGLITAZONE HYDROCHLORIDE 45 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [Chemical/Ingredient],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient] N 20181231 71335-0089_ecff2413-0721-4be3-9980-c2e817796356 71335-0089 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Bryant Ranch Prepack ESZOPICLONE 2 mg/1 CIV N 20191231 71335-0090_77f3a75c-5943-48ea-af4f-ea9ffbc4b800 71335-0090 HUMAN PRESCRIPTION DRUG OXCARBAZEPINE OXCARBAZEPINE TABLET, FILM COATED ORAL 20080111 ANDA ANDA078069 Bryant Ranch Prepack OXCARBAZEPINE 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71335-0091_c8fe9520-15dd-422f-9b26-bd7bda4997e3 71335-0091 HUMAN PRESCRIPTION DRUG Benzonatate Benzonatate CAPSULE ORAL 20070409 ANDA ANDA040597 Bryant Ranch Prepack BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] N 20181231 71335-0092_e64b4eaf-48d3-4f18-a427-20d235f9849b 71335-0092 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20090909 ANDA ANDA075009 Bryant Ranch Prepack ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 71335-0093_a9f6bde2-54db-49bd-909c-c522bd667d1d 71335-0093 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20130523 ANDA ANDA090843 Bryant Ranch Prepack LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71335-0094_e87aacac-be91-40c2-9c41-0f6c99ce8850 71335-0094 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED ORAL 20040401 ANDA ANDA076604 Bryant Ranch Prepack HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20191231 71335-0095_b0729b37-2637-4f01-a755-6d5f18f24e42 71335-0095 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Bryant Ranch Prepack NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0096_b990f4ac-1f0a-4057-bc98-ec39ce62b08a 71335-0096 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20150325 ANDA ANDA078722 Bryant Ranch Prepack CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 71335-0097_72e698db-a042-44c1-a2ca-f3bc0110b80e 71335-0097 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160829 ANDA ANDA202696 Bryant Ranch Prepack VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 71335-0098_5b1429b4-7448-4f22-beb2-497ae9a8e298 71335-0098 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931001 ANDA ANDA074342 Bryant Ranch Prepack ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 71335-0099_63bc37cd-20a9-4a26-996b-611d69b31ebe 71335-0099 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20170831 ANDA ANDA207466 Bryant Ranch Prepack METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20191231 71335-0100_5b5ecc37-0269-4569-9b55-00165c323883 71335-0100 HUMAN OTC DRUG Loratadine Allergy Relief Loratadine TABLET ORAL 20030828 ANDA ANDA076134 Bryant Ranch Prepack LORATADINE 10 mg/1 N 20191231 71335-0101_d9d88000-dd87-45b7-a62d-28e931e33b4d 71335-0101 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20070511 ANDA ANDA077987 Bryant Ranch Prepack PRAVASTATIN SODIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 71335-0102_bfd00cba-e8cc-4817-b1d5-0078e331befc 71335-0102 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Bryant Ranch Prepack ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 71335-0103_584b66fe-ccc9-4cbc-bf4c-31c21d831c60 71335-0103 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20051201 ANDA ANDA077241 Bryant Ranch Prepack BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20191231 71335-0104_311a9e2b-5474-41e3-a0af-8454783ac875 71335-0104 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Ibuprofen Hydrocodone Bitartrate and Ibuprofen TABLET ORAL 20100218 ANDA ANDA076642 Bryant Ranch Prepack HYDROCODONE BITARTRATE; IBUPROFEN 7.5; 200 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] CII N 20191231 71335-0105_f2278c22-43aa-4ac3-b543-42b49c3181ba 71335-0105 HUMAN PRESCRIPTION DRUG lansoprazole lansoprazole CAPSULE, DELAYED RELEASE PELLETS ORAL 20130823 ANDA ANDA202366 Bryant Ranch Prepack LANSOPRAZOLE 30 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE] N 20191231 71335-0106_227169d0-d369-4030-82b6-2639222024ee 71335-0106 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20160419 ANDA ANDA202036 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0107_3b6e5e83-6046-43cc-b733-a38b7f6ed702 71335-0107 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Bryant Ranch Prepack INDOMETHACIN 50 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0108_630fcfaa-59a0-402b-832d-e02d81677a58 71335-0108 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20120411 ANDA ANDA201013 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 71335-0109_1caf88e4-c95e-40d8-9642-d31e3535a506 71335-0109 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20090127 ANDA ANDA040863 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 71335-0110_98aeb7de-8659-4e65-9f37-c0dce28e63b9 71335-0110 HUMAN PRESCRIPTION DRUG phendimetrazine tartrate phendimetrazine tartrate TABLET ORAL 20000406 ANDA ANDA089452 Bryant Ranch Prepack PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20191231 71335-0111_4156e208-6f89-485e-be6c-b3d7d21d0bdc 71335-0111 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET ORAL 20091217 ANDA ANDA090485 Bryant Ranch Prepack TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 71335-0112_5efb7f86-c57f-47c8-93ab-381e68ef9a11 71335-0112 HUMAN PRESCRIPTION DRUG Allopurinol ALLOPURINOL TABLET ORAL 20150429 ANDA ANDA203154 Bryant Ranch Prepack ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20191231 71335-0114_6f493263-0197-4b07-b708-c714fbb53c2b 71335-0114 HUMAN PRESCRIPTION DRUG glyburide and metformin hydrochloride glyburide and metformin hydrochloride TABLET ORAL 20160407 ANDA ANDA206748 Bryant Ranch Prepack GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 71335-0115_edd0d72e-be65-4d64-95f1-9da07434dfc7 71335-0115 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 5 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0116_ecff2413-0721-4be3-9980-c2e817796356 71335-0116 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Bryant Ranch Prepack ESZOPICLONE 3 mg/1 CIV N 20191231 71335-0117_399716e1-8e76-4b59-8147-3dd17abef413 71335-0117 HUMAN PRESCRIPTION DRUG Orphenadrine Citrate Orphenadrine Citrate TABLET ORAL 20000215 ANDA ANDA040327 Bryant Ranch Prepack ORPHENADRINE CITRATE 100 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 71335-0118_544d800a-57d9-493d-9da3-4f677271870b 71335-0118 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride labetalol hydrochloride TABLET ORAL 20141201 NDA NDA018716 Bryant Ranch Prepack LABETALOL HYDROCHLORIDE 300 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0119_e66b90d5-3f27-4ac4-8494-9f8d98e95a29 71335-0119 HUMAN PRESCRIPTION DRUG METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE TABLET ORAL 19470813 NDA NDA006134 Bryant Ranch Prepack METHADONE HYDROCHLORIDE 10 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0120_1bde8a39-b387-4d86-aff1-429eaa7b402d 71335-0120 HUMAN PRESCRIPTION DRUG Lithium Carbonate Lithium Carbonate CAPSULE ORAL 20091215 ANDA ANDA090702 Bryant Ranch Prepack LITHIUM CARBONATE 300 mg/1 Mood Stabilizer [EPC] N 20191231 71335-0121_e3dd5b69-5c0f-488c-97ae-981c8dc71d2a 71335-0121 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Bryant Ranch Prepack CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 71335-0122_3b9f1a5f-2237-4410-8f4d-9bfac28d0ff4 71335-0122 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Bryant Ranch Prepack MIRTAZAPINE 15 mg/1 N 20191231 71335-0123_688f8359-fe64-433a-8490-028c9231d3c0 71335-0123 HUMAN PRESCRIPTION DRUG Valacyclovir hydrochloride Valacyclovir hydrochloride TABLET ORAL 20100524 ANDA ANDA077135 Bryant Ranch Prepack VALACYCLOVIR HYDROCHLORIDE 1000 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 71335-0125_6ff5be4c-1870-4b35-8028-83cecd5afcd3 71335-0125 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060130 ANDA ANDA077651 Bryant Ranch Prepack ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 71335-0126_08b78480-8667-4a5d-a227-50f4022ae7e0 71335-0126 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20030501 ANDA ANDA076004 Bryant Ranch Prepack ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0127_6f493263-0197-4b07-b708-c714fbb53c2b 71335-0127 HUMAN PRESCRIPTION DRUG glyburide and metformin hydrochloride glyburide and metformin hydrochloride TABLET ORAL 20160407 ANDA ANDA206748 Bryant Ranch Prepack GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 71335-0128_2b413821-bc97-492c-a455-d288afd24418 71335-0128 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 Bryant Ranch Prepack CYCLOBENZAPRINE HYDROCHLORIDE 5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 71335-0129_887cd453-bb44-48f6-9e4f-0bbc7c73227f 71335-0129 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Bryant Ranch Prepack FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 71335-0130_a425835e-f3e5-4a1a-b78b-2a002a3d89a1 71335-0130 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140328 ANDA ANDA201003 Bryant Ranch Prepack RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20191231 71335-0131_eaeebe75-77bc-4b0b-bf82-f398760b64d9 71335-0131 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20150601 ANDA ANDA205085 Bryant Ranch Prepack CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20191231 71335-0132_d4aeee90-bf79-4474-bf55-056e74269b1f 71335-0132 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070727 ANDA ANDA077851 Bryant Ranch Prepack ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 71335-0133_2a2141db-ebf9-472e-875d-c6f80325498c 71335-0133 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 Bryant Ranch Prepack LEVOFLOXACIN 750 mg/1 N 20191231 71335-0134_3ab48670-fc13-47a3-b5b9-04e87c4f2e23 71335-0134 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110606 ANDA ANDA078179 Bryant Ranch Prepack ZOLPIDEM TARTRATE 12.5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20191231 71335-0135_d9af608c-2682-4ff8-83bd-8b38d3876c9b 71335-0135 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090324 ANDA ANDA079095 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 71335-0136_0258c538-7511-4143-ab1a-f6446dde8c9b 71335-0136 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20090601 ANDA ANDA040796 Bryant Ranch Prepack FOLIC ACID 1 mg/1 N 20191231 71335-0137_35c0bd3f-4ce6-4558-a157-e6831f479551 71335-0137 HUMAN PRESCRIPTION DRUG Indomethacin extended-release Indomethacin extended-release CAPSULE ORAL 20151005 ANDA ANDA202706 Bryant Ranch Prepack INDOMETHACIN 75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0138_1c5f6ce8-8729-4f38-ba0e-5869f9ad1ef5 71335-0138 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19951130 ANDA ANDA074394 Bryant Ranch Prepack DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0139_c16ed5bf-5624-46fe-93a1-fad0db637fd5 71335-0139 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20090115 ANDA ANDA078993 Bryant Ranch Prepack LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 71335-0140_e1586a8a-5adf-43b8-b2bb-25b8bbbe17c5 71335-0140 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 750 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 71335-0141_40aa1975-efa9-41f5-9980-ed70587f1682 71335-0141 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET ORAL 20150513 ANDA ANDA079128 Bryant Ranch Prepack LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20191231 71335-0142_529b1e30-0725-404e-b6cf-3b6c86b09103 71335-0142 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071136 Bryant Ranch Prepack DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 71335-0143_5e1cd739-a21d-4535-9c70-cacdb88ed0f0 71335-0143 HUMAN OTC DRUG Meclizine HCl 25 mg Meclizine Hydrochloride TABLET, CHEWABLE ORAL 20151015 OTC MONOGRAPH FINAL part336 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 25 mg/1 N 20191231 71335-0144_e538dea2-0592-4031-8ab5-dd82a5f75229 71335-0144 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Bryant Ranch Prepack OXCARBAZEPINE 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 71335-0145_71ba933a-033b-42f5-906a-4caf267def50 71335-0145 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 71335-0146_ed439a7e-3f72-4abd-85cc-d99e4a4a7a59 71335-0146 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120117 ANDA ANDA202677 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0147_d0cb32ba-6cd0-42a4-ac80-ada2b5802b13 71335-0147 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090917 ANDA ANDA078906 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 71335-0148_c476c9b7-fb15-420a-b09f-c9c303f1d69e 71335-0148 HUMAN PRESCRIPTION DRUG ESZOPICLONE ESZOPICLONE TABLET, FILM COATED ORAL 20140925 ANDA ANDA091113 Bryant Ranch Prepack ESZOPICLONE 2 mg/1 CIV N 20191231 71335-0149_12bc6f60-3df0-4f1e-8f20-254a08cecbfd 71335-0149 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Bryant Ranch Prepack METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0150_ed3e19f5-01dd-4e31-b64e-ef4e589190f9 71335-0150 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20101005 ANDA ANDA090937 Bryant Ranch Prepack GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 71335-0151_62cdff01-3c35-4611-9622-930e08cdbfc3 71335-0151 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED ORAL 20051216 ANDA ANDA077184 Bryant Ranch Prepack TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN 37.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20191231 71335-0152_abf2641e-a4c8-433f-932a-b5003df172b1 71335-0152 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Bryant Ranch Prepack LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 50; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 71335-0153_b2c6d160-e95d-4024-9e51-8daef4313bfa 71335-0153 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 20100604 ANDA ANDA040659 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20191231 71335-0154_dba387b2-e50b-4d2d-9840-b0d30d7c37d5 71335-0154 HUMAN PRESCRIPTION DRUG ZOLPIDEM TARTRATE zolpidem tartrate TABLET ORAL 20070905 ANDA ANDA077903 Bryant Ranch Prepack ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20191231 71335-0155_201efa65-c7b2-4b79-bf30-7256ec49a528 71335-0155 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Bryant Ranch Prepack NORTRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 71335-0156_66861174-c916-45cb-8061-3ba559bfc376 71335-0156 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 125 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 71335-0157_67935af3-3417-4703-b958-02d51762394c 71335-0157 HUMAN OTC DRUG Enteric Coated Aspirin Regular Strength Aspirin TABLET, DELAYED RELEASE ORAL 20110104 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ASPIRIN 325 mg/3251 CIV N 20191231 71335-0158_12bc6f60-3df0-4f1e-8f20-254a08cecbfd 71335-0158 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 Bryant Ranch Prepack METOPROLOL SUCCINATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0159_7fecc5ac-fa18-4aad-a3f9-89e58e0b997e 71335-0159 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Bryant Ranch Prepack DIGOXIN 250 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20191231 71335-0160_fd06fcce-18b1-44e7-950f-78bea965c0b5 71335-0160 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride TABLET ORAL 19991103 ANDA ANDA040317 Bryant Ranch Prepack DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 71335-0161_08b207d8-aeb2-4128-9035-a879b9f9121a 71335-0161 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20110308 ANDA ANDA200272 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20191231 71335-0162_c779f3b8-1b40-4921-af2a-3d2fbeb860d0 71335-0162 HUMAN PRESCRIPTION DRUG Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride TABLET ORAL 20150213 ANDA ANDA203027 Bryant Ranch Prepack LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20191231 71335-0163_7ef56836-1a86-4ddb-a8c6-5c0a34aa34d2 71335-0163 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 Bryant Ranch Prepack ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 71335-0164_dc2519b1-9430-4708-be7c-05e146d4f796 71335-0164 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 150 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 71335-0165_59fe3074-6643-49a8-9e4f-0842017a6219 71335-0165 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 20 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0166_9680f8f6-1c4c-4543-a4a2-15108666745d 71335-0166 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20121203 ANDA ANDA200295 Bryant Ranch Prepack LIOTHYRONINE SODIUM 25 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20191231 71335-0167_c04a22ea-38c9-47a3-af3e-1064e91c2558 71335-0167 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA078889 Bryant Ranch Prepack METOPROLOL SUCCINATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0168_4a2cc62f-2a62-47c8-977b-638b6c4505fe 71335-0168 HUMAN PRESCRIPTION DRUG Doxycycline Doxycycline CAPSULE ORAL 20160429 ANDA ANDA204446 Bryant Ranch Prepack DOXYCYCLINE 100 mg/1 N 20191231 71335-0169_bfd00cba-e8cc-4817-b1d5-0078e331befc 71335-0169 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET, FILM COATED ORAL 20130405 ANDA ANDA091624 Bryant Ranch Prepack ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 71335-0170_1aee9670-5654-48f4-a1bd-339501b0ddd9 71335-0170 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20021106 ANDA ANDA076201 Bryant Ranch Prepack DICLOFENAC SODIUM 100 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0171_bc6e387e-90cc-469e-9bff-12203d343967 71335-0171 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Bryant Ranch Prepack DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 2.5; 2.5; 2.5; 2.5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 71335-0172_5c0cc290-ae0e-4dd8-9172-657d2c5536e5 71335-0172 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20080226 ANDA ANDA077728 Bryant Ranch Prepack CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20191231 71335-0173_d85f76b2-1b4b-4e13-a660-89dcc495215b 71335-0173 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141226 ANDA ANDA202446 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 75 mg/1 Tricyclic Antidepressant [EPC] N 20191231 71335-0174_edd0d72e-be65-4d64-95f1-9da07434dfc7 71335-0174 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0175_8412d0cc-05c0-4af2-985f-63b7361652f0 71335-0175 HUMAN PRESCRIPTION DRUG Diethylpropion Hydrochloride Diethylpropion Hydrochloride TABLET ORAL 20110718 ANDA ANDA200177 Bryant Ranch Prepack DIETHYLPROPION HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20191231 71335-0176_60890d53-7f42-4bc0-90ad-ea9d47906fce 71335-0176 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Bryant Ranch Prepack LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 71335-0177_296918ad-9c34-4ee2-8fdf-669d57d5b06a 71335-0177 HUMAN PRESCRIPTION DRUG Dexamethasone dexamethasone TABLET ORAL 19830428 ANDA ANDA088238 Bryant Ranch Prepack DEXAMETHASONE 4 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 71335-0178_6b97e3aa-8cb6-402b-a433-8405b7587c2a 71335-0178 HUMAN PRESCRIPTION DRUG Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET ORAL 20070509 ANDA ANDA040444 Bryant Ranch Prepack DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 71335-0179_1593914a-7909-43e8-8ac6-1315ab5cc5ce 71335-0179 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Bryant Ranch Prepack GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 71335-0180_cffaa472-3232-461f-be41-0397617657d0 71335-0180 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Bryant Ranch Prepack GLIMEPIRIDE 4 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 71335-0181_d645cb12-9757-4a46-a613-b6922dec3be9 71335-0181 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Bryant Ranch Prepack LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 71335-0182_f2cdac9a-393f-462b-a0fa-7028008c04ac 71335-0182 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20060117 ANDA ANDA076143 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 71335-0183_446a1118-0800-40d7-831f-87a422d5b6d9 71335-0183 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED, EXTENDED RELEASE ORAL 20140215 ANDA ANDA091134 Bryant Ranch Prepack ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0184_7e151fe8-d793-4e67-8ff8-40b1417906a9 71335-0184 HUMAN PRESCRIPTION DRUG venlafaxine hydrochloride venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20110601 ANDA ANDA090174 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0185_227169d0-d369-4030-82b6-2639222024ee 71335-0185 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20160419 ANDA ANDA202036 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0186_414dc9b7-b728-4e31-9aa8-31ab2b8dd411 71335-0186 HUMAN PRESCRIPTION DRUG Metaxalone Metaxalone TABLET ORAL 20130531 ANDA ANDA203399 Bryant Ranch Prepack METAXALONE 800 mg/1 Centrally-mediated Muscle Relaxation [PE] N 20191231 71335-0187_59aeb65d-ad2d-463c-a9e8-3561623c5c63 71335-0187 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril TABLET ORAL 20160616 ANDA ANDA077222 Bryant Ranch Prepack FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 71335-0188_494e0dec-4d3c-4003-9e7a-54dfdddfbd7f 71335-0188 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, COATED ORAL 20110802 UNAPPROVED DRUG OTHER Bryant Ranch Prepack PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20191231 71335-0189_d31b133c-f2f5-4954-a722-dca52d46f58d 71335-0189 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride Meclizine Hydrochloride TABLET ORAL 20120430 ANDA ANDA200294 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 12.5 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20191231 71335-0190_0bf4bdaa-8647-442d-9596-9eb9efef54b9 71335-0190 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Extended Release Diltiazem Hydrochloride CAPSULE, COATED, EXTENDED RELEASE ORAL 19991220 ANDA ANDA074984 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 240 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 71335-0191_c8d2db92-9391-4d2d-a417-cc722b68967d 71335-0191 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/ Macrocrystalline Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110525 NDA NDA020064 Bryant Ranch Prepack NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20191231 71335-0192_544a350d-b83b-4d1f-bf32-decc8364d513 71335-0192 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Bryant Ranch Prepack METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0193_bc5e22d1-2045-437e-bfe4-ca0032253c9a 71335-0193 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20071127 ANDA ANDA040777 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0194_afda3448-fb2b-4fc1-bf3b-c1fc9cd1c780 71335-0194 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Butalbital, Acetaminophen, Caffeine and Codeine Phosphate CAPSULE ORAL 20040701 ANDA ANDA076560 Bryant Ranch Prepack BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE 50; 325; 40; 30 mg/1; mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 71335-0195_3ba72c7d-951d-4dfd-b53c-d46251e1e2c1 71335-0195 HUMAN OTC DRUG Aspirin aspirin TABLET, COATED ORAL 20140114 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ASPIRIN 81 mg/1 CIV N 20191231 71335-0196_3c873ba9-6b14-4d78-bce4-a688fd33b67a 71335-0196 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20110608 ANDA ANDA091604 Bryant Ranch Prepack RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 71335-0197_6f7cdd92-a390-497d-86fa-19c3d39fe23a 71335-0197 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil olmesartan medoxomil TABLET, FILM COATED ORAL 20161026 NDA NDA021286 Bryant Ranch Prepack OLMESARTAN MEDOXOMIL 40 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 71335-0198_bc6e387e-90cc-469e-9bff-12203d343967 71335-0198 HUMAN PRESCRIPTION DRUG Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate Dextroamphetamine saccharate, Amphetamine aspartate, Dextroamphetamine sulfate, and Amphetamine sulfate TABLET ORAL 20030909 ANDA ANDA040480 Bryant Ranch Prepack DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE 5; 5; 5; 5 mg/1; mg/1; mg/1; mg/1 Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20191231 71335-0199_73e9790c-0c0d-44e8-8328-e129d5086dcd 71335-0199 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110303 ANDA ANDA091179 Bryant Ranch Prepack PROMETHAZINE HYDROCHLORIDE 12.5 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20191231 71335-0200_06a25472-4161-4551-868d-1cc18bc77dfd 71335-0200 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Bryant Ranch Prepack CLINDAMYCIN HYDROCHLORIDE 150 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 71335-0201_8be07ae6-bc0c-4685-a91c-d085c17a4d01 71335-0201 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Bryant Ranch Prepack ESTRADIOL 2 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20191231 71335-0202_afc0d9c8-4eec-4eeb-82f8-4ba2f2be89d7 71335-0202 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20100101 ANDA ANDA040901 Bryant Ranch Prepack HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20191231 71335-0203_780b94bb-742f-43ac-bb16-1b244e519415 71335-0203 HUMAN PRESCRIPTION DRUG Olmesartan Medoxomil and Hydrochlorothiazide olmesartan medoxomil-hydrochlorothiazide TABLET, FILM COATED ORAL 20161026 NDA NDA021532 Bryant Ranch Prepack OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE 40; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 71335-0205_2fb36ad9-acbe-4bcd-897c-765bf691580e 71335-0205 HUMAN PRESCRIPTION DRUG Ondansetron Hydrochloride Ondansetron Hydrochloride TABLET, FILM COATED ORAL 20070731 ANDA ANDA078539 Bryant Ranch Prepack ONDANSETRON HYDROCHLORIDE 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 71335-0206_7acbac5d-d8a8-4f11-bb7b-9f28057d5212 71335-0206 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20110101 ANDA ANDA078504 Bryant Ranch Prepack BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20191231 71335-0209_edd0d72e-be65-4d64-95f1-9da07434dfc7 71335-0209 HUMAN PRESCRIPTION DRUG OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET ORAL 20121226 ANDA ANDA077290 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0210_4182d3c1-2fa3-4f73-b47f-c607be4999a1 71335-0210 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0211_94df1f36-4c78-41ea-9508-4ef66db0200d 71335-0211 HUMAN PRESCRIPTION DRUG Cyproheptadine Hydrochloride Cyproheptadine Hydrochloride TABLET ORAL 20170117 ANDA ANDA206553 Bryant Ranch Prepack CYPROHEPTADINE HYDROCHLORIDE 4 mg/1 N 20191231 71335-0212_98a03cb5-a185-4acc-991c-31a531027278 71335-0212 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 Bryant Ranch Prepack PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 71335-0213_642f9332-a47c-46fb-99c0-733f358376e5 71335-0213 HUMAN OTC DRUG SENNA-S Sennosides and Docusate Sodium TABLET, FILM COATED ORAL 20160201 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack SENNOSIDES; DOCUSATE SODIUM 8.6; 50 mg/1; mg/1 N 20191231 71335-0214_1c5d7a8f-9329-456c-937e-ce71be65256e 71335-0214 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Bryant Ranch Prepack GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 71335-0215_7ef56836-1a86-4ddb-a8c6-5c0a34aa34d2 71335-0215 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 Bryant Ranch Prepack ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 71335-0216_ed439a7e-3f72-4abd-85cc-d99e4a4a7a59 71335-0216 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20160309 ANDA ANDA202677 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0217_b0729b37-2637-4f01-a755-6d5f18f24e42 71335-0217 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20070701 ANDA ANDA078250 Bryant Ranch Prepack NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0218_73223924-2463-4a43-b71d-3c4013405d7e 71335-0218 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Bryant Ranch Prepack AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 71335-0219_933e0579-c9a5-45be-962a-d50982c0d80a 71335-0219 HUMAN OTC DRUG Sunmark Arthritis 8 Hour Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Bryant Ranch Prepack ACETAMINOPHEN 650 mg/1 N 20191231 71335-0220_1c5d7a8f-9329-456c-937e-ce71be65256e 71335-0220 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20091124 ANDA ANDA078428 Bryant Ranch Prepack GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 71335-0221_ef7e851d-c5ad-45e3-a562-de692b83ddbe 71335-0221 HUMAN PRESCRIPTION DRUG oxycodone and acetaminophen oxycodone and acetaminophen TABLET ORAL 20151102 ANDA ANDA090535 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0222_cf0c55bd-4a3b-4aa8-8881-1f73ede9619e 71335-0222 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 10 mg/1 N 20191231 71335-0223_ad9ffea8-0cf2-431b-8a12-5537af972ffb 71335-0223 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET ORAL 20160301 ANDA ANDA091239 Bryant Ranch Prepack IBUPROFEN 200 mg/1 N 20191231 71335-0224_556a04c9-64e6-4325-bb18-6fc55e4f0077 71335-0224 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 Bryant Ranch Prepack HYDROXYZINE PAMOATE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20191231 71335-0225_e7dd4072-4a91-45ca-8a34-3409efa11c1f 71335-0225 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Bryant Ranch Prepack ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 71335-0226_be439e50-b9de-4228-9369-e02dc9f92711 71335-0226 HUMAN PRESCRIPTION DRUG ESTRADIOL ESTRADIOL TABLET ORAL 20170410 ANDA ANDA040275 Bryant Ranch Prepack ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20191231 71335-0227_a05a9ff0-34ea-452e-850e-00f873b5392e 71335-0227 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 Bryant Ranch Prepack VALSARTAN; HYDROCHLOROTHIAZIDE 160; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 71335-0229_6f7824b6-bfd8-4b26-b127-70a2d8dee63a 71335-0229 HUMAN PRESCRIPTION DRUG HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET ORAL 20090514 ANDA ANDA076855 Bryant Ranch Prepack HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0230_19e3a69d-d144-4a1e-8a95-7d126a057607 71335-0230 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020702 ANDA ANDA076262 Bryant Ranch Prepack LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 71335-0231_fcc7f8af-586e-40ac-8a93-f21b68ca712d 71335-0231 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 Bryant Ranch Prepack FAMOTIDINE 40 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 71335-0232_d28f77ec-aeb1-4230-8526-331997ebf8fc 71335-0232 HUMAN PRESCRIPTION DRUG PHENYTOIN SODIUM PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE ORAL 20061212 ANDA ANDA040621 Bryant Ranch Prepack PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] N 20191231 71335-0233_587b5b5f-ee10-4f96-870d-e2846c2e8008 71335-0233 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA077471 Bryant Ranch Prepack HYDROMORPHONE HYDROCHLORIDE 8 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0234_c209d964-e08a-4124-bd65-6188adbc1b82 71335-0234 HUMAN PRESCRIPTION DRUG propranolol hydrochloride propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20130311 ANDA ANDA078703 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 60 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0235_8ee578f3-e0a4-4499-b42d-89516f0bde97 71335-0235 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20131108 ANDA ANDA091643 Bryant Ranch Prepack FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20191231 71335-0236_6a2943f8-528e-4157-9abc-02b2cb3fd169 71335-0236 HUMAN PRESCRIPTION DRUG zaleplon zaleplon CAPSULE ORAL 20090505 ANDA ANDA078989 Bryant Ranch Prepack ZALEPLON 5 mg/1 gamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE] CIV N 20191231 71335-0237_cede3118-9a54-4434-80dc-8210dadbf0f8 71335-0237 HUMAN PRESCRIPTION DRUG Tamoxifen Citrate Tamoxifen Citrate TABLET, FILM COATED ORAL 20160803 ANDA ANDA074858 Bryant Ranch Prepack TAMOXIFEN CITRATE 20 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20191231 71335-0238_e8604628-04ab-4b06-88fb-290fee879e23 71335-0238 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0239_934d081b-dc42-4c26-8012-a0a5452b1536 71335-0239 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151026 ANDA ANDA203849 Bryant Ranch Prepack MORPHINE SULFATE 15 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0240_300ffbf5-9682-404f-b4f5-d14458590bbe 71335-0240 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE 6.25; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0241_ce1b0848-ee39-4216-8956-1dfe7317e23c 71335-0241 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Bryant Ranch Prepack METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0242_51792606-d70e-4d9f-8402-3f51cb29352b 71335-0242 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Bryant Ranch Prepack AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 40 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 71335-0243_7f26916b-2d3d-4335-aadd-9c3b3989ee87 71335-0243 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150407 ANDA ANDA040616 Bryant Ranch Prepack WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 71335-0244_96b83560-e3c5-4bec-ba81-b7af78a58bdf 71335-0244 HUMAN PRESCRIPTION DRUG Rabeprazole Sodium Rabeprazole Sodium TABLET, DELAYED RELEASE ORAL 20131108 ANDA ANDA090678 Bryant Ranch Prepack RABEPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 71335-0245_8a620cf7-e1e6-4955-9a47-c6146282bf0d 71335-0245 HUMAN PRESCRIPTION DRUG Naproxen delayed release Naproxen TABLET ORAL 20120123 ANDA ANDA091432 Bryant Ranch Prepack NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0246_d16c43d5-4ca5-4234-804c-ffe6344b0463 71335-0246 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20121022 ANDA ANDA088619 Bryant Ranch Prepack HYDROXYZINE HYDROCHLORIDE 50 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20191231 71335-0247_7ef56836-1a86-4ddb-a8c6-5c0a34aa34d2 71335-0247 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 Bryant Ranch Prepack ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 71335-0249_d645cb12-9757-4a46-a613-b6922dec3be9 71335-0249 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Bryant Ranch Prepack LOSARTAN POTASSIUM 25 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 71335-0250_090aae59-c8c6-4c99-b026-ff662df19189 71335-0250 HUMAN PRESCRIPTION DRUG Metformin hydrochloride Metformin hydrochloride TABLET ORAL 20100422 ANDA ANDA090564 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 71335-0251_72a3dd3d-e444-4cad-8f18-aff9d1844cbf 71335-0251 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET ORAL 20130320 ANDA ANDA090200 Bryant Ranch Prepack METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 71335-0252_5b1429b4-7448-4f22-beb2-497ae9a8e298 71335-0252 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931001 ANDA ANDA074342 Bryant Ranch Prepack ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 71335-0253_5fe414e3-8baa-48ef-a9a4-1ec8db227b60 71335-0253 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20020228 ANDA ANDA075022 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20191231 71335-0254_8f9c41f3-637d-4cd5-b593-567f5935cba2 71335-0254 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20060401 ANDA ANDA077662 Bryant Ranch Prepack GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 71335-0255_f51fcdc0-7359-4c7c-9a8d-429fe5acaf7b 71335-0255 HUMAN PRESCRIPTION DRUG NAPROXEN NAPROXEN TABLET ORAL 20160706 ANDA ANDA091416 Bryant Ranch Prepack NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0256_5e6e54b7-43e5-4de4-8d1e-5cbe2a05ceb8 71335-0256 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170105 ANDA ANDA202800 Bryant Ranch Prepack ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 71335-0257_a768a4e2-31ba-4f43-939b-91760f7abf50 71335-0257 HUMAN PRESCRIPTION DRUG Terbinafine Hydrochloride Terbinafine Hydrochloride TABLET ORAL 20140813 ANDA ANDA077137 Bryant Ranch Prepack TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20191231 71335-0258_494e0dec-4d3c-4003-9e7a-54dfdddfbd7f 71335-0258 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET, COATED ORAL 20110802 UNAPPROVED DRUG OTHER Bryant Ranch Prepack PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20191231 71335-0259_ff552957-cec4-442e-81a3-c25f9f11f40d 71335-0259 HUMAN PRESCRIPTION DRUG Modafinil modafinil TABLET ORAL 20140203 ANDA ANDA077667 Bryant Ranch Prepack MODAFINIL 200 mg/1 Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC] CIV N 20191231 71335-0260_508cd35e-6eda-4ce2-b860-eca847bb7959 71335-0260 HUMAN PRESCRIPTION DRUG Sotalol Hydrochloride Sotalol Hydrochloride TABLET ORAL 20030201 ANDA ANDA076140 Bryant Ranch Prepack SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20191231 71335-0261_46c4ba94-2277-47d0-b861-e8c18560edc6 71335-0261 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20160427 ANDA ANDA202554 Bryant Ranch Prepack LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 71335-0262_9b79d53d-e3d8-45b8-96c6-8a48edb51b38 71335-0262 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan potassium TABLET, FILM COATED ORAL 20140730 ANDA ANDA091497 Bryant Ranch Prepack LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 71335-0263_87ea459f-b3ad-484f-b7f6-629814f0fa41 71335-0263 HUMAN PRESCRIPTION DRUG ziprasidone hydrochloride ziprasidone hydrochloride CAPSULE ORAL 20130213 ANDA ANDA077562 Bryant Ranch Prepack ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20191231 71335-0264_0eb2f2ab-a7f1-4f7b-b5f0-4f7c97a6dbf6 71335-0264 HUMAN PRESCRIPTION DRUG fluvoxamine maleate Fluvoxamine maleate TABLET, COATED ORAL 20110809 NDA AUTHORIZED GENERIC NDA021519 Bryant Ranch Prepack FLUVOXAMINE MALEATE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0265_587b5b5f-ee10-4f96-870d-e2846c2e8008 71335-0265 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA077471 Bryant Ranch Prepack HYDROMORPHONE HYDROCHLORIDE 2 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0266_725396b8-c977-4220-a154-1865a933cd85 71335-0266 HUMAN PRESCRIPTION DRUG DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20010730 ANDA ANDA074943 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 180 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 71335-0267_d620d857-0e73-459f-b236-80ed5ab8d378 71335-0267 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 71335-0268_829d4409-2774-46d1-930a-fdb12f454027 71335-0268 HUMAN PRESCRIPTION DRUG Hydroxyzine hydrochloride Hydroxyzine hydrochloride TABLET ORAL 20120324 ANDA ANDA204279 Bryant Ranch Prepack HYDROXYZINE HYDROCHLORIDE 10 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20191231 71335-0269_71ba933a-033b-42f5-906a-4caf267def50 71335-0269 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20130410 ANDA ANDA202556 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 71335-0270_7f26916b-2d3d-4335-aadd-9c3b3989ee87 71335-0270 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20151019 ANDA ANDA040616 Bryant Ranch Prepack WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 71335-0271_d0cb32ba-6cd0-42a4-ac80-ada2b5802b13 71335-0271 HUMAN PRESCRIPTION DRUG verapamil hydrochloride verapamil hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110805 ANDA ANDA090700 Bryant Ranch Prepack VERAPAMIL HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 71335-0272_cf0c55bd-4a3b-4aa8-8881-1f73ede9619e 71335-0272 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 15 mg/1 N 20191231 71335-0273_84feb30f-fe0e-4a23-b370-2796d943f38f 71335-0273 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Bryant Ranch Prepack CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 71335-0274_393ee40c-0b01-452e-94f5-63ff8b204ddf 71335-0274 HUMAN OTC DRUG Naproxen Sodium Naproxen Sodium TABLET ORAL 20120501 ANDA ANDA090545 Bryant Ranch Prepack NAPROXEN SODIUM 220 mg/1 N 20191231 71335-0275_8e360a68-75fe-4222-b595-ca163063ef12 71335-0275 HUMAN PRESCRIPTION DRUG Isoniazid Isoniazid TABLET ORAL 19720901 ANDA ANDA080937 Bryant Ranch Prepack ISONIAZID 300 mg/1 Antimycobacterial [EPC] N 20191231 71335-0276_01a44a30-d474-4b16-b1e6-ca29b2284155 71335-0276 HUMAN PRESCRIPTION DRUG LAMOTRIGINE Lamotrigine TABLET ORAL 20101101 ANDA ANDA077783 Bryant Ranch Prepack LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 71335-0278_24177b30-0667-429c-8598-f1dfccfec0a8 71335-0278 HUMAN PRESCRIPTION DRUG VITAMIN D ergocalciferol CAPSULE ORAL 20140516 ANDA ANDA090455 Bryant Ranch Prepack ERGOCALCIFEROL 1.25 1/1 Ergocalciferols [Chemical/Ingredient],Provitamin D2 Compound [EPC] N 20191231 71335-0279_314470e5-8090-4b35-9f71-3b0c22dfffdc 71335-0279 HUMAN PRESCRIPTION DRUG Amantadine HCl AMANTADINE HYDROCHLORIDE CAPSULE, LIQUID FILLED ORAL 20160815 ANDA ANDA078720 Bryant Ranch Prepack AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20191231 71335-0280_8313c983-98e4-4530-a4a7-9d1b3373c948 71335-0280 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20150201 ANDA ANDA075090 Bryant Ranch Prepack ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 71335-0281_8e382cee-0f81-4f8b-bcd6-335f24babe42 71335-0281 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20140920 ANDA ANDA203687 Bryant Ranch Prepack FINASTERIDE 1 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20191231 71335-0282_7fecc5ac-fa18-4aad-a3f9-89e58e0b997e 71335-0282 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20020726 ANDA ANDA076268 Bryant Ranch Prepack DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20191231 71335-0283_d3f75f35-97b1-4237-bcf3-060c24a56b75 71335-0283 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20070423 ANDA ANDA076410 Bryant Ranch Prepack ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV N 20191231 71335-0284_676c2b7b-2838-4e62-be81-9e7572b0f1d2 71335-0284 HUMAN PRESCRIPTION DRUG Lisinopril with Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020708 ANDA ANDA076265 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 20 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 71335-0285_f82289ab-f8f7-46aa-9233-fed03c443a33 71335-0285 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate DOXYCYCLINE HYCLATE CAPSULE ORAL 19840911 ANDA ANDA062500 Bryant Ranch Prepack DOXYCYCLINE HYCLATE 100 mg/1 N 20191231 71335-0286_e1d37f7d-0d49-4031-8345-61e7210c54b9 71335-0286 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20040422 ANDA ANDA076541 Bryant Ranch Prepack MIRTAZAPINE 15 mg/1 N 20191231 71335-0287_acbac224-599e-48c9-8c11-68c1038fe316 71335-0287 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 19900930 ANDA ANDA071523 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 71335-0288_1590ea3d-4be0-4f96-b994-0b76902e0ba0 71335-0288 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20130531 ANDA ANDA078380 Bryant Ranch Prepack SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 71335-0289_fd1c66be-86a3-46fc-93b2-b49d3dfdf789 71335-0289 HUMAN PRESCRIPTION DRUG Potassium Chloride Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20020410 ANDA ANDA075604 Bryant Ranch Prepack POTASSIUM CHLORIDE 10 meq/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] N 20191231 71335-0290_29930eca-8126-4dcf-845c-dcb8ee8c0318 71335-0290 HUMAN OTC DRUG Fexofenadine Hydrochloride Fexofenadine HCl TABLET, FILM COATED ORAL 20110808 ANDA ANDA076447 Bryant Ranch Prepack FEXOFENADINE HYDROCHLORIDE 60 mg/1 N 20191231 71335-0291_1857d379-d88b-4d3d-9d4d-d1e07cb8696e 71335-0291 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole TABLET, DELAYED RELEASE ORAL 20160620 ANDA ANDA205119 Bryant Ranch Prepack PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 71335-0292_2b9f3d76-cbc6-4d20-bb25-ec05e976948a 71335-0292 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 Bryant Ranch Prepack CELECOXIB 100 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0293_1c164e89-e803-4712-9d23-775bbbac352f 71335-0293 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE EXTENDED RELEASE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20160512 ANDA ANDA090295 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 71335-0294_d0815b37-38dc-4683-84d7-bf0c884be692 71335-0294 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20000101 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack DOCUSATE SODIUM 100 mg/1 N 20191231 71335-0295_f3f691d1-b99b-415c-9272-2f8af27bc515 71335-0295 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Bryant Ranch Prepack ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 71335-0296_e9d1604b-0bdf-43b6-8566-244e2300d3d7 71335-0296 HUMAN PRESCRIPTION DRUG PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET ORAL 20170216 ANDA ANDA207068 Bryant Ranch Prepack PRAVASTATIN SODIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 71335-0297_e1fd9ec9-30e3-498d-a73a-a2f936b4020e 71335-0297 HUMAN PRESCRIPTION DRUG Torsemide Torsemide TABLET ORAL 20071017 ANDA ANDA078249 Bryant Ranch Prepack TORSEMIDE 10 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 71335-0298_66861174-c916-45cb-8061-3ba559bfc376 71335-0298 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 150 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 71335-0299_ef6413fe-7657-4851-aca9-38dab60123be 71335-0299 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Bryant Ranch Prepack OMEPRAZOLE 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0300_e37ae24d-62ff-465b-bedf-851003088ad8 71335-0300 HUMAN OTC DRUG Cetirizine Hydrochloride Cetirizine Hydrochloride TABLET ORAL 20091001 ANDA ANDA077829 Bryant Ranch Prepack CETIRIZINE HYDROCHLORIDE 10 mg/1 N 20191231 71335-0301_73eda5e0-cbe3-452c-bda4-78ba0bcc2365 71335-0301 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA090984 Bryant Ranch Prepack MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 71335-0302_e18cf0ea-f913-412e-9f9d-018b2c056a22 71335-0302 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA206434 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 71335-0303_587b5b5f-ee10-4f96-870d-e2846c2e8008 71335-0303 HUMAN PRESCRIPTION DRUG Hydromorphone Hydrochloride Hydromorphone Hydrochloride TABLET ORAL 20091209 ANDA ANDA077471 Bryant Ranch Prepack HYDROMORPHONE HYDROCHLORIDE 4 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0304_ad282a60-6c8a-4a86-9982-8df78d9489ff 71335-0304 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170602 ANDA ANDA203512 Bryant Ranch Prepack SPIRONOLACTONE 100 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20191231 71335-0305_e87ee19c-bc64-46a2-8727-8edd349d047b 71335-0305 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 19851224 NDA AUTHORIZED GENERIC NDA018998 Bryant Ranch Prepack ENALAPRIL MALEATE 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 71335-0306_d85f76b2-1b4b-4e13-a660-89dcc495215b 71335-0306 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 25 mg/1 Tricyclic Antidepressant [EPC] N 20191231 71335-0307_4ada4558-632a-43e3-9f61-5a41e39705bc 71335-0307 HUMAN PRESCRIPTION DRUG Fenoprofen Calcium fenoprofen calcium CAPSULE ORAL 20160519 NDA AUTHORIZED GENERIC NDA017604 Bryant Ranch Prepack FENOPROFEN CALCIUM 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0309_c8191156-62da-472b-8a69-0bafeb29dc01 71335-0309 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20170614 ANDA ANDA202824 Bryant Ranch Prepack DOXAZOSIN MESYLATE 2 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 71335-0310_7223daef-4ba1-46db-8c4c-9930d4e097de 71335-0310 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20120928 ANDA ANDA202038 Bryant Ranch Prepack PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 71335-0311_b1b2e4b2-e55f-4ffe-95f0-c428fa837699 71335-0311 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20170707 ANDA ANDA086727 Bryant Ranch Prepack DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CII N 20191231 71335-0312_51792606-d70e-4d9f-8402-3f51cb29352b 71335-0312 HUMAN PRESCRIPTION DRUG Amlodipine and Benazepril Hydrochloride Amlodipine and Benazepril Hydrochloride CAPSULE ORAL 20120905 ANDA ANDA202239 Bryant Ranch Prepack AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE 5; 10 mg/1; mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 71335-0313_c93ef494-4410-4ab7-afb0-583d95861aed 71335-0313 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20160829 ANDA ANDA206556 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 71335-0314_d9af608c-2682-4ff8-83bd-8b38d3876c9b 71335-0314 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride SR bupropion hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090324 ANDA ANDA079095 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 100 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 71335-0316_ed439a7e-3f72-4abd-85cc-d99e4a4a7a59 71335-0316 HUMAN PRESCRIPTION DRUG Oxycodone and Acetaminophen Oxycodone and Acetaminophen TABLET ORAL 20120117 ANDA ANDA202677 Bryant Ranch Prepack OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0317_1e8b03d7-275c-4522-9d8a-77007eaf772a 71335-0317 HUMAN PRESCRIPTION DRUG Tizanidine Hydrochloride Tizanidine Hydrochloride CAPSULE, GELATIN COATED ORAL 20120206 ANDA ANDA078868 Bryant Ranch Prepack TIZANIDINE HYDROCHLORIDE 6 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 71335-0318_76f09eaf-b675-4e36-a479-398101544b4b 71335-0318 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET, DELAYED RELEASE ORAL 20160705 ANDA ANDA091432 Bryant Ranch Prepack NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0319_e7dd4072-4a91-45ca-8a34-3409efa11c1f 71335-0319 HUMAN PRESCRIPTION DRUG acyclovir acyclovir TABLET ORAL 20140910 ANDA ANDA204314 Bryant Ranch Prepack ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 71335-0320_06a25472-4161-4551-868d-1cc18bc77dfd 71335-0320 HUMAN PRESCRIPTION DRUG Clindamycin hydrochloride Clindamycin hydrochloride CAPSULE ORAL 20010323 ANDA ANDA065061 Bryant Ranch Prepack CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 71335-0321_a8e25583-9d68-44a1-81e0-e953b9751b99 71335-0321 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE HEMIHYDRATE 30 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0322_2891ab1b-9c62-4259-bab1-c7815bdc3f00 71335-0322 HUMAN PRESCRIPTION DRUG escitalopram oxalate escitalopram oxalate TABLET ORAL 20120911 ANDA ANDA090939 Bryant Ranch Prepack ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0323_8c578838-95da-4c76-a510-1e58445a9aca 71335-0323 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20131129 ANDA ANDA203834 Bryant Ranch Prepack ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20191231 71335-0324_0d45b028-186a-4a07-91cd-3b0cee592ec4 71335-0324 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 Bryant Ranch Prepack PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20191231 71335-0325_5a5b273f-165c-45ef-9426-5ae84a65ba4f 71335-0325 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 Bryant Ranch Prepack TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0326_7238d622-4323-4427-b6cd-cccee21f04b7 71335-0326 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20090921 ANDA ANDA071251 Bryant Ranch Prepack TRIAMTERENE; HYDROCHLOROTHIAZIDE 75; 50 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 71335-0327_d4ff3199-e990-41c3-afbb-bbcd0ad47bfb 71335-0327 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Bryant Ranch Prepack LEVOFLOXACIN 250 mg/1 N 20191231 71335-0328_1bf06dd3-e3a6-4646-8db5-99ed9c5f29bc 71335-0328 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20160721 ANDA ANDA077397 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0331_0df91aba-a9d8-495b-94a8-8a5185eba48d 71335-0331 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20150217 ANDA ANDA077285 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20191231 71335-0332_776fe97f-f28e-4669-87bc-83b45a21d6fc 71335-0332 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20090121 ANDA ANDA075576 Bryant Ranch Prepack OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0336_5e6e54b7-43e5-4de4-8d1e-5cbe2a05ceb8 71335-0336 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20170105 ANDA ANDA202800 Bryant Ranch Prepack ACETAMINOPHEN; CODEINE PHOSPHATE 300; 60 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 71335-0337_2b83ac9d-fd3e-4e1c-85b4-510650a25764 71335-0337 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Bryant Ranch Prepack TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0338_263f570e-2376-45f6-9aa6-b6d06cb9d5d3 71335-0338 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20121001 ANDA ANDA091022 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 120 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20191231 71335-0339_cd36b0f9-5d42-47de-9821-fb07027f2ccb 71335-0339 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Bryant Ranch Prepack CIPROFLOXACIN HYDROCHLORIDE 750 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 71335-0340_3847fb41-d7d5-402f-b5d7-0b6f9a2d020a 71335-0340 HUMAN OTC DRUG Low Dose Aspirin Aspirin TABLET ORAL 20091103 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ASPIRIN 81 mg/1 CIV N 20191231 71335-0341_9680f8f6-1c4c-4543-a4a2-15108666745d 71335-0341 HUMAN PRESCRIPTION DRUG Liothyronine Sodium Liothyronine Sodium TABLET ORAL 20121203 ANDA ANDA200295 Bryant Ranch Prepack LIOTHYRONINE SODIUM 5 ug/1 l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20191231 71335-0342_f9ab369c-017f-4fe7-803b-eb3bd29af07b 71335-0342 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Bryant Ranch Prepack RANITIDINE HYDROCHLORIDE 300 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 71335-0343_dc2519b1-9430-4708-be7c-05e146d4f796 71335-0343 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20081117 ANDA ANDA071196 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 71335-0344_584b66fe-ccc9-4cbc-bf4c-31c21d831c60 71335-0344 HUMAN PRESCRIPTION DRUG Baclofen baclofen TABLET ORAL 20070701 ANDA ANDA078220 Bryant Ranch Prepack BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] N 20191231 71335-0345_c77d636b-763f-4c0d-a870-1af1f491fb96 71335-0345 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Bryant Ranch Prepack NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0346_57e8996a-f52b-4c91-bcf3-17a2b4df90ee 71335-0346 HUMAN PRESCRIPTION DRUG Memantine Hydrochloride Memantine Hydrochloride TABLET ORAL 20150827 ANDA ANDA206528 Bryant Ranch Prepack MEMANTINE HYDROCHLORIDE 5 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20191231 71335-0347_b23736d2-51d2-49a1-871c-3d9ff1f742ee 71335-0347 HUMAN PRESCRIPTION DRUG butalbital, acetaminophen and caffeine butalbital, acetaminophen and caffeine TABLET ORAL 19870121 ANDA ANDA089175 Bryant Ranch Prepack BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20191231 71335-0348_7f26916b-2d3d-4335-aadd-9c3b3989ee87 71335-0348 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150407 ANDA ANDA040616 Bryant Ranch Prepack WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 71335-0349_c8191156-62da-472b-8a69-0bafeb29dc01 71335-0349 HUMAN PRESCRIPTION DRUG Doxazosin Doxazosin TABLET ORAL 20150422 ANDA ANDA202824 Bryant Ranch Prepack DOXAZOSIN MESYLATE 4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 71335-0350_51d68f7c-6460-4413-9703-191c1cdfee2f 71335-0350 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20130812 ANDA ANDA040526 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20191231 71335-0351_9e2b1fce-2b6d-48dc-a866-b6cf574cb009 71335-0351 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140403 ANDA ANDA075350 Bryant Ranch Prepack GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 71335-0352_e3e03a68-ea65-4e47-9c84-0cd59b413326 71335-0352 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH NOT FINAL part348 Bryant Ranch Prepack DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 71335-0353_787d7ead-2639-41bd-9444-f5b8e17e83b7 71335-0353 HUMAN PRESCRIPTION DRUG Buprenorphine Buprenorphine TABLET SUBLINGUAL 20150219 ANDA ANDA090819 Bryant Ranch Prepack BUPRENORPHINE HYDROCHLORIDE 2 mg/1 Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] CIII N 20191231 71335-0354_60890d53-7f42-4bc0-90ad-ea9d47906fce 71335-0354 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076164 Bryant Ranch Prepack LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 71335-0355_3b6e5e83-6046-43cc-b733-a38b7f6ed702 71335-0355 HUMAN PRESCRIPTION DRUG Indomethacin Indomethacin CAPSULE ORAL 20101222 ANDA ANDA091276 Bryant Ranch Prepack INDOMETHACIN 25 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0356_7238d622-4323-4427-b6cd-cccee21f04b7 71335-0356 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide TABLET ORAL 20090921 ANDA ANDA071251 Bryant Ranch Prepack TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 71335-0357_a5f7b979-c943-482e-9b2c-2d9e78970b19 71335-0357 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Bryant Ranch Prepack DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0358_7fe89a68-94f6-4334-88c6-0bf12ceaac78 71335-0358 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET, FILM COATED ORAL 20140601 ANDA ANDA203458 Bryant Ranch Prepack METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20191231 71335-0359_2b83ac9d-fd3e-4e1c-85b4-510650a25764 71335-0359 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Bryant Ranch Prepack TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0360_1593914a-7909-43e8-8ac6-1315ab5cc5ce 71335-0360 HUMAN PRESCRIPTION DRUG Glyburide and Metformin Hydrochloride Glyburide and Metformin Hydrochloride TABLET, FILM COATED ORAL 20071114 ANDA ANDA077870 Bryant Ranch Prepack GLYBURIDE; METFORMIN HYDROCHLORIDE 5; 500 mg/1; mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20191231 71335-0361_2b9f3d76-cbc6-4d20-bb25-ec05e976948a 71335-0361 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150603 ANDA ANDA204197 Bryant Ranch Prepack CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0362_af1839e6-a5bd-4bff-833c-0ef2747a0061 71335-0362 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 19900930 ANDA ANDA070184 Bryant Ranch Prepack METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20191231 71335-0363_f9ab369c-017f-4fe7-803b-eb3bd29af07b 71335-0363 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20081119 ANDA ANDA078542 Bryant Ranch Prepack RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 71335-0365_11f6aa9f-a544-4000-b376-cec16c299abc 71335-0365 HUMAN PRESCRIPTION DRUG Butalbital, Acetaminophen, and Caffeine Butalbital, Acetaminophen, and Caffeine TABLET ORAL 20120913 ANDA ANDA200243 Bryant Ranch Prepack BUTALBITAL; ACETAMINOPHEN; CAFFEINE 50; 325; 40 mg/1; mg/1; mg/1 Barbiturate [EPC],Barbiturates [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] CIII N 20191231 71335-0366_d85f76b2-1b4b-4e13-a660-89dcc495215b 71335-0366 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 50 mg/1 Tricyclic Antidepressant [EPC] N 20191231 71335-0367_fe99d219-4cba-4545-8417-95b0c7c5b12a 71335-0367 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE ORAL 20131211 ANDA ANDA090778 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0368_84feb30f-fe0e-4a23-b370-2796d943f38f 71335-0368 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Bryant Ranch Prepack CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 71335-0372_3b9f1a5f-2237-4410-8f4d-9bfac28d0ff4 71335-0372 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Bryant Ranch Prepack MIRTAZAPINE 30 mg/1 N 20191231 71335-0374_73eda5e0-cbe3-452c-bda4-78ba0bcc2365 71335-0374 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET ORAL 20120803 ANDA ANDA201515 Bryant Ranch Prepack MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 71335-0377_e8604628-04ab-4b06-88fb-290fee879e23 71335-0377 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0379_053c55e6-6c79-4fcc-b4aa-458cca414b39 71335-0379 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Bryant Ranch Prepack RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] N 20191231 71335-0380_d4ff3199-e990-41c3-afbb-bbcd0ad47bfb 71335-0380 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Bryant Ranch Prepack LEVOFLOXACIN 500 mg/1 N 20191231 71335-0381_59aeb65d-ad2d-463c-a9e8-3561623c5c63 71335-0381 HUMAN PRESCRIPTION DRUG Fosinopril Sodium Fosinopril TABLET ORAL 20160616 ANDA ANDA077222 Bryant Ranch Prepack FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 71335-0383_227169d0-d369-4030-82b6-2639222024ee 71335-0383 HUMAN PRESCRIPTION DRUG Venlafaxine Venlafaxine Hydrochloride TABLET ORAL 20160419 ANDA ANDA202036 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 37.5 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0384_887cd453-bb44-48f6-9e4f-0bbc7c73227f 71335-0384 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20060201 ANDA ANDA077293 Bryant Ranch Prepack FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 71335-0385_390c1980-1096-4b7b-bf07-8cf6a320cbd7 71335-0385 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20090330 ANDA ANDA090118 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 71335-0390_e18cf0ea-f913-412e-9f9d-018b2c056a22 71335-0390 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA206434 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 71335-0391_2a2141db-ebf9-472e-875d-c6f80325498c 71335-0391 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 Bryant Ranch Prepack LEVOFLOXACIN 500 mg/1 N 20191231 71335-0392_59fe3074-6643-49a8-9e4f-0842017a6219 71335-0392 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 30 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0393_c9f27654-c926-4a7e-b4fa-685ed58ea778 71335-0393 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET, FILM COATED ORAL 20010131 ANDA ANDA075855 Bryant Ranch Prepack OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0394_f8121b32-962a-43ff-886a-014a31135adc 71335-0394 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET ORAL 20091216 ANDA ANDA077824 Bryant Ranch Prepack RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 71335-0395_d85f76b2-1b4b-4e13-a660-89dcc495215b 71335-0395 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141205 ANDA ANDA202446 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20191231 71335-0397_02664c90-3a5b-48cf-b5a5-a967414af14f 71335-0397 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19810827 NDA NDA018487 Bryant Ranch Prepack FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 71335-0398_0e3f1449-2209-4067-839f-9fd57bff5997 71335-0398 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride Tamsulosin Hydrochloride CAPSULE ORAL 20130430 ANDA ANDA202433 Bryant Ranch Prepack TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20191231 71335-0399_08b78480-8667-4a5d-a227-50f4022ae7e0 71335-0399 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, FILM COATED ORAL 20030501 ANDA ANDA076004 Bryant Ranch Prepack ETODOLAC 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0400_ee52212a-9d58-46f2-85d7-1e298575207b 71335-0400 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET, FILM COATED ORAL 20100530 ANDA ANDA072193 Bryant Ranch Prepack TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] N 20191231 71335-0401_ad282a60-6c8a-4a86-9982-8df78d9489ff 71335-0401 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20170602 ANDA ANDA203512 Bryant Ranch Prepack SPIRONOLACTONE 50 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] N 20191231 71335-0402_47e4ca7f-766d-4e5c-8f19-1fee4ea57b05 71335-0402 HUMAN PRESCRIPTION DRUG Duloxetine Duloxetine CAPSULE, DELAYED RELEASE ORAL 20170316 ANDA ANDA208706 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0403_4182d3c1-2fa3-4f73-b47f-c607be4999a1 71335-0403 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET, FILM COATED ORAL 20070206 ANDA ANDA077206 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0404_711e134c-7dcf-4c24-b482-1d8889d25080 71335-0404 HUMAN PRESCRIPTION DRUG Sertraline Sertraline TABLET, FILM COATED ORAL 20070206 ANDA ANDA077670 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0405_48b2d2be-8ea6-4f57-bca5-df802f8e97f5 71335-0405 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071976 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0407_8e682253-7e8c-417b-8520-10a6f7854fc8 71335-0407 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20070227 ANDA ANDA040755 Bryant Ranch Prepack CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20191231 71335-0408_cd36b0f9-5d42-47de-9821-fb07027f2ccb 71335-0408 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20040910 ANDA ANDA076639 Bryant Ranch Prepack CIPROFLOXACIN HYDROCHLORIDE 250 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 71335-0409_fcc7f8af-586e-40ac-8a93-f21b68ca712d 71335-0409 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET ORAL 20160129 ANDA ANDA078916 Bryant Ranch Prepack FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20191231 71335-0410_e538dea2-0592-4031-8ab5-dd82a5f75229 71335-0410 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077802 Bryant Ranch Prepack OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 71335-0411_abf2641e-a4c8-433f-932a-b5003df172b1 71335-0411 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Bryant Ranch Prepack LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 71335-0412_1234065b-a08c-4b69-8fde-8baee58eeac7 71335-0412 HUMAN PRESCRIPTION DRUG aripiprazole aripiprazole TABLET ORAL 20150428 ANDA ANDA201519 Bryant Ranch Prepack ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 71335-0413_4e73028b-e437-4de3-9a90-210e104b3a4e 71335-0413 HUMAN PRESCRIPTION DRUG SULINDAC sulindac TABLET ORAL 20090904 ANDA ANDA072051 Bryant Ranch Prepack SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0414_bc1b2aab-e62a-42fd-b18c-b19b64391bbe 71335-0414 HUMAN PRESCRIPTION DRUG NP Thyroid 60 LEVOTHYROXINE, LIOTHYRONINE TABLET ORAL 20101111 UNAPPROVED DRUG OTHER Bryant Ranch Prepack LEVOTHYROXINE; LIOTHYRONINE 38; 9 ug/1; ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient],l-Triiodothyronine [EPC],Triiodothyronine [Chemical/Ingredient] N 20181231 71335-0415_4bcab184-7766-41b9-9041-a2d943e75fc0 71335-0415 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170209 ANDA ANDA202825 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 71335-0416_0445448a-7d07-4b56-a794-e49dcde4c7ee 71335-0416 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20120817 ANDA ANDA201146 Bryant Ranch Prepack DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 71335-0417_585281ec-8360-4554-b6fc-5eb059556f81 71335-0417 HUMAN OTC DRUG Regular Strength Pain Relief Acetaminophen TABLET ORAL 19890101 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ACETAMINOPHEN 325 mg/1 N 20181231 71335-0418_2846d6d5-337a-47cd-9f21-413238968e09 71335-0418 HUMAN PRESCRIPTION DRUG LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED ORAL 20160111 ANDA ANDA205564 Bryant Ranch Prepack LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg/1 Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 71335-0419_2de6c8cd-c1d8-40ce-b35e-b4cec163957f 71335-0419 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120217 ANDA ANDA202248 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 15 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 71335-0420_ce1b0848-ee39-4216-8956-1dfe7317e23c 71335-0420 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Bryant Ranch Prepack METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0421_66861174-c916-45cb-8061-3ba559bfc376 71335-0421 HUMAN PRESCRIPTION DRUG Levothyroxine sodium Levothyroxine sodium TABLET ORAL 20020301 NDA AUTHORIZED GENERIC NDA021342 Bryant Ranch Prepack LEVOTHYROXINE SODIUM 50 ug/1 l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient] N 20191231 71335-0422_5b1429b4-7448-4f22-beb2-497ae9a8e298 71335-0422 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 19931001 ANDA ANDA074342 Bryant Ranch Prepack ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 71335-0423_83a1aff5-7cd9-4951-afa4-73d884e47d85 71335-0423 HUMAN PRESCRIPTION DRUG IRBESARTAN IRBESARTAN TABLET ORAL 20160701 ANDA ANDA091236 Bryant Ranch Prepack IRBESARTAN 150 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 71335-0425_1e4708a9-23d5-4166-81e8-cf0dc5063f1e 71335-0425 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 19990226 ANDA ANDA040230 Bryant Ranch Prepack DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 71335-0426_201efa65-c7b2-4b79-bf30-7256ec49a528 71335-0426 HUMAN PRESCRIPTION DRUG Nortriptyline Hydrochloride Nortriptyline Hydrochloride CAPSULE ORAL 20000508 ANDA ANDA075520 Bryant Ranch Prepack NORTRIPTYLINE HYDROCHLORIDE 10 mg/1 Tricyclic Antidepressant [EPC] N 20191231 71335-0430_8be07ae6-bc0c-4685-a91c-d085c17a4d01 71335-0430 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Bryant Ranch Prepack ESTRADIOL .5 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20191231 71335-0431_9295dcaa-f35a-4f73-82bd-da3fb6ea773e 71335-0431 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100811 ANDA ANDA090598 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20191231 71335-0432_1288bf5c-a586-405a-96a0-f306daa8e956 71335-0432 HUMAN PRESCRIPTION DRUG Quetiapine Quetiapine TABLET, FILM COATED ORAL 20120328 ANDA ANDA202152 Bryant Ranch Prepack QUETIAPINE FUMARATE 300 mg/1 Atypical Antipsychotic [EPC] N 20191231 71335-0433_898e105c-4f59-43dd-981d-16a8d3b72026 71335-0433 HUMAN PRESCRIPTION DRUG Finasteride finasteride TABLET, FILM COATED ORAL 20100528 ANDA ANDA090121 Bryant Ranch Prepack FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20191231 71335-0434_b33a40c8-6801-48a7-85cc-5ee7e7fad321 71335-0434 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150109 ANDA ANDA202801 Bryant Ranch Prepack LEVOFLOXACIN 500 mg/1 N 20191231 71335-0435_c68e6cc4-8f25-4ab1-bd13-3e205b36bf67 71335-0435 HUMAN OTC DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride CAPSULE ORAL 20090102 OTC MONOGRAPH NOT FINAL part348 Bryant Ranch Prepack DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20191231 71335-0436_f2f7f6db-6652-402a-b31b-16a54e10dbad 71335-0436 HUMAN PRESCRIPTION DRUG doxycycline doxycycline CAPSULE ORAL 20160314 ANDA ANDA205115 Bryant Ranch Prepack DOXYCYCLINE 100 mg/1 N 20191231 71335-0437_7cbcfd2d-c803-436d-a3ba-0edffae5160f 71335-0437 HUMAN PRESCRIPTION DRUG Celecoxib celecoxib CAPSULE ORAL 20150415 ANDA ANDA078857 Bryant Ranch Prepack CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0438_556a04c9-64e6-4325-bb18-6fc55e4f0077 71335-0438 HUMAN PRESCRIPTION DRUG HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE CAPSULE ORAL 20101117 ANDA ANDA201507 Bryant Ranch Prepack HYDROXYZINE PAMOATE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20191231 71335-0439_2d416bf9-8bfa-4d9f-b42b-085ec3f09141 71335-0439 HUMAN PRESCRIPTION DRUG Ketoconazole Ketoconazole TABLET ORAL 19990615 ANDA ANDA075319 Bryant Ranch Prepack KETOCONAZOLE 200 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20191231 71335-0440_fcfef74e-df78-446d-a10d-f497e2eba0b7 71335-0440 HUMAN PRESCRIPTION DRUG PNV Prenatal Plus Multivitamin VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, and CUPRIC OXIDE TABLET ORAL 20130401 UNAPPROVED DRUG OTHER Bryant Ranch Prepack VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE 2000; 2000; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2 [iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC] N 20191231 71335-0441_e1d37f7d-0d49-4031-8345-61e7210c54b9 71335-0441 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20040422 ANDA ANDA076541 Bryant Ranch Prepack MIRTAZAPINE 30 mg/1 N 20191231 71335-0442_d645cb12-9757-4a46-a613-b6922dec3be9 71335-0442 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Bryant Ranch Prepack LOSARTAN POTASSIUM 100 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 71335-0443_86beccba-2748-4bb7-841d-b6e85819c377 71335-0443 HUMAN PRESCRIPTION DRUG Calcitriol Calcitriol CAPSULE, LIQUID FILLED ORAL 20130529 ANDA ANDA091174 Bryant Ranch Prepack CALCITRIOL .25 ug/1 Cholecalciferol [Chemical/Ingredient],Vitamin D3 Analog [EPC] N 20191231 71335-0444_5a4682ae-9a5f-4056-80c0-fa409bdd5ff0 71335-0444 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 19861210 ANDA ANDA071322 Bryant Ranch Prepack DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 71335-0445_8be07ae6-bc0c-4685-a91c-d085c17a4d01 71335-0445 HUMAN PRESCRIPTION DRUG Estradiol Estradiol TABLET ORAL 19971028 ANDA ANDA040197 Bryant Ranch Prepack ESTRADIOL 1 mg/1 Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20191231 71335-0447_2bded2bf-20bd-470e-8e02-a688cdba0e85 71335-0447 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE 1 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 71335-0448_7ef56836-1a86-4ddb-a8c6-5c0a34aa34d2 71335-0448 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20151001 ANDA ANDA200739 Bryant Ranch Prepack ALPRAZOLAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 71335-0449_2eb6efd9-f515-4c4e-9ddc-42406909b71f 71335-0449 HUMAN PRESCRIPTION DRUG venlafaxine venlafaxine TABLET ORAL 20151001 ANDA ANDA078932 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 100 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0450_6793a756-1df6-46da-8d2f-1abe4ec734a4 71335-0450 HUMAN PRESCRIPTION DRUG CELECOXIB CELECOXIB CAPSULE ORAL 20150923 ANDA ANDA207446 Bryant Ranch Prepack CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0451_7bb214e0-3071-4b87-90b9-f462dbf12329 71335-0451 HUMAN PRESCRIPTION DRUG BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET ORAL 20100721 ANDA ANDA090968 Bryant Ranch Prepack BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20191231 71335-0452_7f26916b-2d3d-4335-aadd-9c3b3989ee87 71335-0452 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150609 ANDA ANDA040616 Bryant Ranch Prepack WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 71335-0453_3ee14de5-5123-4bab-9ecf-7a604c449043 71335-0453 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20050812 ANDA ANDA065243 Bryant Ranch Prepack CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 71335-0454_8536d770-6485-4dfc-a37a-ad8c8f4eca13 71335-0454 HUMAN PRESCRIPTION DRUG Clindamycin Hydrochloride Clindamycin Hydrochloride CAPSULE ORAL 20160314 ANDA ANDA063029 Bryant Ranch Prepack CLINDAMYCIN HYDROCHLORIDE 300 mg/1 Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient] N 20191231 71335-0456_26af25b7-3a74-4ce4-9e36-e023dca7429a 71335-0456 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 20080819 ANDA ANDA077863 Bryant Ranch Prepack DICLOFENAC SODIUM 75 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0457_d620d857-0e73-459f-b236-80ed5ab8d378 71335-0457 HUMAN PRESCRIPTION DRUG Benazepril Hydrochloride Benazepril Hydrochloride TABLET, COATED ORAL 20140101 ANDA ANDA076118 Bryant Ranch Prepack BENAZEPRIL HYDROCHLORIDE 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 71335-0458_be3f95b1-5184-4fd2-a51a-0c9bee2dda3d 71335-0458 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Bryant Ranch Prepack IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0459_a425835e-f3e5-4a1a-b78b-2a002a3d89a1 71335-0459 HUMAN PRESCRIPTION DRUG RISPERIDONE RISPERIDONE TABLET ORAL 20140328 ANDA ANDA201003 Bryant Ranch Prepack RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] N 20191231 71335-0460_0727d6be-cf18-4e5f-8e64-025e6f07580e 71335-0460 HUMAN PRESCRIPTION DRUG Misoprostol Misoprostol TABLET ORAL 20120725 ANDA ANDA091667 Bryant Ranch Prepack MISOPROSTOL 200 ug/1 Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] N 20181231 71335-0461_c068edb4-8688-4f97-9273-e3d910d90d52 71335-0461 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 19961003 ANDA ANDA074649 Bryant Ranch Prepack CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 71335-0462_9a99627c-b585-4022-aa9a-75dd9fb10c8f 71335-0462 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET ORAL 20091023 ANDA ANDA077272 Bryant Ranch Prepack CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] N 20181231 71335-0463_48b2d2be-8ea6-4f57-bca5-df802f8e97f5 71335-0463 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride Propranolol Hydrochloride TABLET ORAL 19900930 ANDA ANDA071972 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0464_8cb0f932-4251-4444-a59b-a76eebd3bd01 71335-0464 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20090803 ANDA ANDA088832 Bryant Ranch Prepack PREDNISONE 10 mg/1 N 20181231 71335-0466_d6891623-2425-45a9-bc2f-fc9abadfd766 71335-0466 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate and Acetaminophen TABLET ORAL 20160630 ANDA ANDA040746 Bryant Ranch Prepack HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII N 20191231 71335-0467_5efb7f86-c57f-47c8-93ab-381e68ef9a11 71335-0467 HUMAN PRESCRIPTION DRUG Allopurinol allopurinol TABLET ORAL 20150429 ANDA ANDA203154 Bryant Ranch Prepack ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20191231 71335-0468_c2cd45f4-ad1d-44a1-a11f-0917d367d4aa 71335-0468 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, FILM COATED ORAL 20000207 ANDA ANDA075584 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 75 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 71335-0469_30403801-703f-4b06-af33-fe7f8cc8f581 71335-0469 HUMAN PRESCRIPTION DRUG amantadine hydrochloride amantadine hydrochloride CAPSULE ORAL 20160804 ANDA ANDA208278 Bryant Ranch Prepack AMANTADINE HYDROCHLORIDE 100 mg/1 Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] N 20181231 71335-0470_d3a7b380-0583-4b8e-b2d2-e01e117c8a11 71335-0470 HUMAN PRESCRIPTION DRUG ACYCLOVIR ACYCLOVIR CAPSULE ORAL 20060320 ANDA ANDA075677 Bryant Ranch Prepack ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 71335-0471_1e4708a9-23d5-4166-81e8-cf0dc5063f1e 71335-0471 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride CAPSULE ORAL 19740930 ANDA ANDA084285 Bryant Ranch Prepack DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 71335-0472_dd3463e1-7d31-41ea-ab76-ebc29bd6ccd1 71335-0472 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070219 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 40 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 71335-0473_73223924-2463-4a43-b71d-3c4013405d7e 71335-0473 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Bryant Ranch Prepack AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 71335-0474_97251d21-c09a-4c63-a5e9-7b2194eaae65 71335-0474 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20071201 ANDA ANDA087022 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 71335-0475_fe8f5f92-0b54-42ef-a7b4-05e7ea591e7d 71335-0475 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20150831 ANDA ANDA204821 Bryant Ranch Prepack VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 71335-0476_98a03cb5-a185-4acc-991c-31a531027278 71335-0476 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20110120 ANDA ANDA090074 Bryant Ranch Prepack PANTOPRAZOLE SODIUM 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20191231 71335-0477_9e2b1fce-2b6d-48dc-a866-b6cf574cb009 71335-0477 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140423 ANDA ANDA075350 Bryant Ranch Prepack GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20191231 71335-0478_e87ee19c-bc64-46a2-8727-8edd349d047b 71335-0478 HUMAN PRESCRIPTION DRUG Enalapril Maleate Enalapril Maleate TABLET ORAL 19851224 NDA AUTHORIZED GENERIC NDA018998 Bryant Ranch Prepack ENALAPRIL MALEATE 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE] N 20191231 71335-0479_6f06b0e5-b97e-4f11-a8f9-3a603f1dd98a 71335-0479 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20061004 ANDA ANDA077912 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; LISINOPRIL 12.5; 10 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 71335-0480_e8604628-04ab-4b06-88fb-290fee879e23 71335-0480 HUMAN PRESCRIPTION DRUG Citalopram Hydrobromide Citalopram Hydrobromide TABLET ORAL 20071018 ANDA ANDA078216 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0481_a5f7b979-c943-482e-9b2c-2d9e78970b19 71335-0481 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Delayed Release Diclofenac Sodium TABLET, DELAYED RELEASE ORAL 19981113 ANDA ANDA075185 Bryant Ranch Prepack DICLOFENAC SODIUM 50 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0482_ca4af360-a90f-4842-b3f6-bdf614fe552a 71335-0482 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Bryant Ranch Prepack HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 71335-0483_fa18efa2-bc7e-4851-b791-2f10d214f592 71335-0483 HUMAN OTC DRUG Fexofenadine hydrochloride Fexofenadine hydrochloride TABLET, FILM COATED ORAL 20150115 ANDA ANDA202039 Bryant Ranch Prepack FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 71335-0484_cffaa472-3232-461f-be41-0397617657d0 71335-0484 HUMAN PRESCRIPTION DRUG Glimepiride Glimepiride TABLET ORAL 20070823 ANDA ANDA078181 Bryant Ranch Prepack GLIMEPIRIDE 2 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 71335-0485_053c55e6-6c79-4fcc-b4aa-458cca414b39 71335-0485 HUMAN PRESCRIPTION DRUG Risperidone Risperidone TABLET ORAL 20090101 ANDA ANDA079088 Bryant Ranch Prepack RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] N 20191231 71335-0486_cfe8da03-5112-4c48-ae89-99df47736823 71335-0486 HUMAN PRESCRIPTION DRUG zonisamide zonisamide CAPSULE ORAL 20160713 ANDA ANDA077869 Bryant Ranch Prepack ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 71335-0487_5a5b273f-165c-45ef-9426-5ae84a65ba4f 71335-0487 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20141215 ANDA ANDA090278 Bryant Ranch Prepack TOPIRAMATE 50 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0488_72e698db-a042-44c1-a2ca-f3bc0110b80e 71335-0488 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160829 ANDA ANDA202696 Bryant Ranch Prepack VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 71335-0489_324bba50-8dc5-4e25-98f4-6e55b1b9a26a 71335-0489 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 Bryant Ranch Prepack NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 71335-0490_ef6413fe-7657-4851-aca9-38dab60123be 71335-0490 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Bryant Ranch Prepack OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0491_1db31014-01e8-4b11-8c54-c6ca39e6a3b8 71335-0491 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20070831 ANDA ANDA078050 Bryant Ranch Prepack ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20191231 71335-0492_3b5d41a2-c5a4-42b6-b42a-65b39aa1c69e 71335-0492 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20141031 ANDA ANDA091672 Bryant Ranch Prepack OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0494_f1d6bdd1-70d2-41d0-b172-e56810266389 71335-0494 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Bryant Ranch Prepack TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0495_529b1e30-0725-404e-b6cf-3b6c86b09103 71335-0495 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071135 Bryant Ranch Prepack DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 71335-0496_501ee56d-f804-4ddc-9409-c451f475adc5 71335-0496 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, ORALLY DISINTEGRATING ORAL 20100412 ANDA ANDA090469 Bryant Ranch Prepack ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 71335-0497_324bba50-8dc5-4e25-98f4-6e55b1b9a26a 71335-0497 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20141101 ANDA ANDA203126 Bryant Ranch Prepack NIFEDIPINE 30 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 71335-0498_60890d53-7f42-4bc0-90ad-ea9d47906fce 71335-0498 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Bryant Ranch Prepack LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 71335-0499_2b83ac9d-fd3e-4e1c-85b4-510650a25764 71335-0499 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET ORAL 20140612 ANDA ANDA076343 Bryant Ranch Prepack TOPIRAMATE 25 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0500_97fe097a-1ed5-40cb-8311-85c87733530a 71335-0500 HUMAN PRESCRIPTION DRUG Nitrofurantion Macrocrystals Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Bryant Ranch Prepack NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 71335-0501_ed34dd49-6611-4e7f-98e9-7292f10c1c3a 71335-0501 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20170218 ANDA ANDA204375 Bryant Ranch Prepack ZIPRASIDONE HYDROCHLORIDE 80 mg/1 Atypical Antipsychotic [EPC] N 20181231 71335-0502_5fb9fc2e-16f2-4c49-8e38-98d3f2a373ef 71335-0502 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20050622 ANDA ANDA075932 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 200 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 71335-0503_b2c6d160-e95d-4024-9e51-8daef4313bfa 71335-0503 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride TABLET ORAL 20100604 ANDA ANDA040659 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] N 20191231 71335-0504_07eca100-1a28-436d-81c2-820e85423dd1 71335-0504 HUMAN PRESCRIPTION DRUG Triamterene and Hydrochlorothiazide Triamterene and Hydrochlorothiazide CAPSULE ORAL 20111212 ANDA ANDA201407 Bryant Ranch Prepack TRIAMTERENE; HYDROCHLOROTHIAZIDE 37.5; 25 mg/1; mg/1 Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 71335-0505_717568b5-21c2-4e79-89f0-b0a67608660b 71335-0505 HUMAN PRESCRIPTION DRUG Oxcarbazepine Oxcarbazepine TABLET, FILM COATED ORAL 20071009 ANDA ANDA077794 Bryant Ranch Prepack OXCARBAZEPINE 150 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71335-0506_7d40e2cc-8a3b-4a37-99f1-a3f1e6dc8a73 71335-0506 HUMAN OTC DRUG Fexofenadine HCl Fexofenadine HCl TABLET, FILM COATED ORAL 20150916 ANDA ANDA204507 Bryant Ranch Prepack FEXOFENADINE HYDROCHLORIDE 180 mg/1 N 20181231 71335-0507_fc8310a4-901b-4b63-8a35-6bed1d0df1ce 71335-0507 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride TABLET, FILM COATED ORAL 20151216 ANDA ANDA090346 Bryant Ranch Prepack BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 71335-0508_26c7dece-1be2-496f-a056-d0a3a2db172f 71335-0508 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Bryant Ranch Prepack PREDNISONE 5 mg/1 N 20191231 71335-0509_59fe3074-6643-49a8-9e4f-0842017a6219 71335-0509 HUMAN PRESCRIPTION DRUG DULOXETINE DELAYED-RELEASE DULOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS ORAL 20140611 ANDA ANDA203088 Bryant Ranch Prepack DULOXETINE HYDROCHLORIDE 60 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0510_4bcab184-7766-41b9-9041-a2d943e75fc0 71335-0510 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20170209 ANDA ANDA202825 Bryant Ranch Prepack SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 71335-0511_73223924-2463-4a43-b71d-3c4013405d7e 71335-0511 HUMAN PRESCRIPTION DRUG AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET ORAL 20070926 ANDA ANDA077073 Bryant Ranch Prepack AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 71335-0512_086767d2-8612-43a7-be10-163d9f9c0523 71335-0512 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140415 ANDA ANDA091166 Bryant Ranch Prepack ESZOPICLONE 2 mg/1 CIV N 20181231 71335-0513_651bc49d-eebe-41b4-843d-a6bf2e25be26 71335-0513 HUMAN OTC DRUG Regular Strength Enteric coated aspirin Aspirin TABLET, COATED ORAL 20000701 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ASPIRIN 325 mg/1 CIV N 20181231 71335-0514_bea7bdce-4257-4b76-8bce-317b5c0d27d0 71335-0514 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20130411 ANDA ANDA202717 Bryant Ranch Prepack MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 71335-0515_65bd9718-c0be-4259-bb05-e6af5ed199e9 71335-0515 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20161013 ANDA ANDA077836 Bryant Ranch Prepack GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 71335-0516_fd69b448-02df-481b-b7e1-0b54d3cc03bc 71335-0516 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 20100701 ANDA ANDA040823 Bryant Ranch Prepack CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV N 20191231 71335-0517_ce1b0848-ee39-4216-8956-1dfe7317e23c 71335-0517 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Bryant Ranch Prepack METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0519_7c13e295-bb67-47ea-86c4-1f255bc86f50 71335-0519 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride Oxybutynin Chloride TABLET ORAL 19900930 ANDA ANDA071655 Bryant Ranch Prepack OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 71335-0521_c3612266-69a1-44bd-830b-f7ed0e77c5c5 71335-0521 HUMAN PRESCRIPTION DRUG tramadol hydrochloride tramadol hydrochloride TABLET ORAL 20020622 ANDA ANDA075964 Bryant Ranch Prepack TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 71335-0522_d6c9f60d-d9cf-4640-9219-616e21bfd953 71335-0522 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA071250 Bryant Ranch Prepack METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 71335-0523_d104ba5f-43f3-4197-9d31-6c9761b850cc 71335-0523 HUMAN PRESCRIPTION DRUG Metoprolol Succinate Metoprolol Succinate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090804 ANDA ANDA076862 Bryant Ranch Prepack METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 71335-0524_e8e70485-1ca6-4133-b221-c6d547f881fe 71335-0524 HUMAN OTC DRUG Arthritis Pain Reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20020430 ANDA ANDA076200 Bryant Ranch Prepack ACETAMINOPHEN 650 mg/1 N 20181231 71335-0525_2a2141db-ebf9-472e-875d-c6f80325498c 71335-0525 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET ORAL 20120330 ANDA ANDA076890 Bryant Ranch Prepack LEVOFLOXACIN 250 mg/1 N 20191231 71335-0526_4aab93bd-6ca4-4e6e-987a-f0bd2cd92968 71335-0526 HUMAN OTC DRUG Diphenhydramine HCL Diphenhydramine HCL CAPSULE ORAL 20100127 OTC MONOGRAPH NOT FINAL part348 Bryant Ranch Prepack DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 N 20181231 71335-0527_cca28053-1122-4f1c-aa63-10ce6bd68678 71335-0527 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 19900930 ANDA ANDA071620 Bryant Ranch Prepack TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 71335-0528_d6c9f60d-d9cf-4640-9219-616e21bfd953 71335-0528 HUMAN PRESCRIPTION DRUG Metoclopramide Hydrochloride Metoclopramide Hydrochloride TABLET ORAL 20110822 ANDA ANDA072750 Bryant Ranch Prepack METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 71335-0529_f2634e69-fea9-49b1-bb98-f8bf37220a74 71335-0529 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20160726 ANDA ANDA203135 Bryant Ranch Prepack CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 71335-0530_544a350d-b83b-4d1f-bf32-decc8364d513 71335-0530 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Bryant Ranch Prepack METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0531_74028344-cf8d-4e77-82db-b4ec37950132 71335-0531 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20080301 ANDA ANDA078671 Bryant Ranch Prepack NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 71335-0532_e1d37f7d-0d49-4031-8345-61e7210c54b9 71335-0532 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20040422 ANDA ANDA076541 Bryant Ranch Prepack MIRTAZAPINE 45 mg/1 N 20191231 71335-0534_29fe7ed2-aaf9-47d7-bda3-b4af6e9f1f97 71335-0534 HUMAN PRESCRIPTION DRUG Olanzapine Olanzapine TABLET, FILM COATED ORAL 20140822 ANDA ANDA202862 Bryant Ranch Prepack OLANZAPINE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 71335-0535_8054db5c-8692-4ad4-a7f6-c1457a163abb 71335-0535 HUMAN PRESCRIPTION DRUG SULINDAC SULINDAC TABLET ORAL 20100125 ANDA ANDA072711 Bryant Ranch Prepack SULINDAC 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 71335-0536_60890d53-7f42-4bc0-90ad-ea9d47906fce 71335-0536 HUMAN PRESCRIPTION DRUG LISINOPRIL Lisinopril TABLET ORAL 20111101 ANDA ANDA076180 Bryant Ranch Prepack LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20191231 71335-0537_7b2249a6-d565-47ec-95f3-c2bfb9e434ed 71335-0537 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020701 ANDA ANDA076262 Bryant Ranch Prepack LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 25 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 71335-0538_f1d6bdd1-70d2-41d0-b172-e56810266389 71335-0538 HUMAN PRESCRIPTION DRUG Topiramate Topiramate TABLET, FILM COATED ORAL 20090327 ANDA ANDA077627 Bryant Ranch Prepack TOPIRAMATE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20191231 71335-0539_e3dd5b69-5c0f-488c-97ae-981c8dc71d2a 71335-0539 HUMAN PRESCRIPTION DRUG clonidine hydrochloride clonidine hydrochloride TABLET ORAL 20090921 ANDA ANDA078895 Bryant Ranch Prepack CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] N 20191231 71335-0540_e70ce242-4c83-44e5-9ef0-cd7feb0ae5bb 71335-0540 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20051008 ANDA ANDA076900 Bryant Ranch Prepack ATENOLOL 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 71335-0541_bf6d3701-f242-42af-afbf-9013e927a21d 71335-0541 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20160722 ANDA ANDA077534 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 71335-0542_3b9f1a5f-2237-4410-8f4d-9bfac28d0ff4 71335-0542 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET, FILM COATED ORAL 20070822 ANDA ANDA077666 Bryant Ranch Prepack MIRTAZAPINE 45 mg/1 N 20191231 71335-0543_91437425-4e72-48e8-9983-731ab0d67083 71335-0543 HUMAN PRESCRIPTION DRUG Prochlorperazine Maleate prochlorperazine maleate TABLET, FILM COATED ORAL 19961118 ANDA ANDA040185 Bryant Ranch Prepack PROCHLORPERAZINE MALEATE 10 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] N 20181231 71335-0544_a8e25583-9d68-44a1-81e0-e953b9751b99 71335-0544 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine TABLET, FILM COATED ORAL 20070413 ANDA ANDA077584 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71335-0545_7fff54ce-bc63-4507-96ba-64af0760fcec 71335-0545 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Acetaminophen and Codeine TABLET ORAL 20080529 ANDA ANDA040779 Bryant Ranch Prepack ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII N 20191231 71335-0547_a05a9ff0-34ea-452e-850e-00f873b5392e 71335-0547 HUMAN PRESCRIPTION DRUG Valsartan and Hydrochlorothiazide Valsartan and Hydrochlorothiazide TABLET, FILM COATED ORAL 20130419 ANDA ANDA203145 Bryant Ranch Prepack VALSARTAN; HYDROCHLOROTHIAZIDE 320; 25 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 71335-0550_aa01fa9a-7ca4-44f8-b250-6ee67422ab38 71335-0550 HUMAN OTC DRUG DOK DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20150228 OTC MONOGRAPH NOT FINAL part334 Bryant Ranch Prepack DOCUSATE SODIUM 250 mg/1 N 20181231 71335-0551_af94f0a5-e21c-46d1-9989-6137902e8420 71335-0551 HUMAN PRESCRIPTION DRUG PANTOPRAZOLE SODIUM PANTOPRAZOLE TABLET, DELAYED RELEASE ORAL 20140910 ANDA ANDA202882 Bryant Ranch Prepack PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 71335-0552_cf0c55bd-4a3b-4aa8-8881-1f73ede9619e 71335-0552 HUMAN PRESCRIPTION DRUG Buspirone hydrochloride Buspirone hydrochloride TABLET ORAL 20140503 ANDA ANDA078888 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 30 mg/1 N 20191231 71335-0553_8ece88b2-f6e5-4c30-894f-71bc7cc7ad6f 71335-0553 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA090642 Bryant Ranch Prepack VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 71335-0554_dd3463e1-7d31-41ea-ab76-ebc29bd6ccd1 71335-0554 HUMAN PRESCRIPTION DRUG Propranolol Hydrochloride propranolol hydrochloride TABLET ORAL 20100621 ANDA ANDA070217 Bryant Ranch Prepack PROPRANOLOL HYDROCHLORIDE 10 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 71335-0555_72e698db-a042-44c1-a2ca-f3bc0110b80e 71335-0555 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20160829 ANDA ANDA202696 Bryant Ranch Prepack VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20191231 71335-0556_3bff2db9-ce41-4418-8328-42f80b16e383 71335-0556 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20070820 ANDA ANDA077062 Bryant Ranch Prepack FENTANYL 50 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 71335-0557_8c4358bd-8a6f-46fa-833f-88d214280fdc 71335-0557 HUMAN PRESCRIPTION DRUG Fluconazole Fluconazole TABLET ORAL 20060125 ANDA ANDA077253 Bryant Ranch Prepack FLUCONAZOLE 100 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] N 20181231 71335-0558_abf2641e-a4c8-433f-932a-b5003df172b1 71335-0558 HUMAN PRESCRIPTION DRUG Losartan Potassium and Hydrochlorothiazide Losartan Potassium and Hydrochlorothiazide TABLET, FILM COATED ORAL 20101006 ANDA ANDA091629 Bryant Ranch Prepack LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE 100; 12.5 mg/1; mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20191231 71335-0559_2dcca0ed-3335-4d37-ac64-d81843d9beb5 71335-0559 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20030128 ANDA ANDA075757 Bryant Ranch Prepack OMEPRAZOLE 10 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 71335-0560_2bded2bf-20bd-470e-8e02-a688cdba0e85 71335-0560 HUMAN PRESCRIPTION DRUG ropinirole ropinirole TABLET, FILM COATED ORAL 20100225 ANDA ANDA090135 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20191231 71335-0561_84feb30f-fe0e-4a23-b370-2796d943f38f 71335-0561 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20070905 ANDA ANDA078332 Bryant Ranch Prepack CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20191231 71335-0562_3f08e758-023c-483f-9da3-7e11421228a4 71335-0562 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20161215 ANDA ANDA202557 Bryant Ranch Prepack BUSPIRONE HYDROCHLORIDE 5 mg/1 N 20181231 71335-0563_86546998-d1d7-4c14-a1a0-dc144d1a58bf 71335-0563 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20100701 ANDA ANDA076565 Bryant Ranch Prepack VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 71335-0564_730c2c63-a01f-4031-99f5-008ed94ef4e7 71335-0564 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride CAPSULE ORAL 20120807 ANDA ANDA040875 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 71335-0565_b063f778-2cdf-4587-8fb9-40697a3f0342 71335-0565 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20160129 ANDA ANDA090223 Bryant Ranch Prepack FLUOXETINE HYDROCHLORIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 71335-0566_d85f76b2-1b4b-4e13-a660-89dcc495215b 71335-0566 HUMAN PRESCRIPTION DRUG AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20141226 ANDA ANDA202446 Bryant Ranch Prepack AMITRIPTYLINE HYDROCHLORIDE 150 mg/1 Tricyclic Antidepressant [EPC] N 20191231 71335-0567_fe8f5f92-0b54-42ef-a7b4-05e7ea591e7d 71335-0567 HUMAN PRESCRIPTION DRUG Valsartan valsartan TABLET ORAL 20150831 ANDA ANDA204821 Bryant Ranch Prepack VALSARTAN 80 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 71335-0568_4f603708-6237-4f17-bf69-b53dd78fdede 71335-0568 HUMAN OTC DRUG Regular Strength Aspirin EC Aspirin TABLET, DELAYED RELEASE ORAL 20110909 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ASPIRIN 325 mg/1 N 20181231 71335-0569_1fe052c7-e212-4912-8fe4-90175dd6ea23 71335-0569 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20031111 ANDA ANDA076048 Bryant Ranch Prepack OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 71335-0570_2dd14886-7dc7-4504-8e46-82335679e8bc 71335-0570 HUMAN PRESCRIPTION DRUG Minocycline Hydrochloride Minocycline Hydrochloride CAPSULE ORAL 20150402 ANDA ANDA065062 Bryant Ranch Prepack MINOCYCLINE HYDROCHLORIDE 50 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20191231 71335-0572_2ef84434-e0df-42e3-93cf-8b05a2b5adb5 71335-0572 HUMAN PRESCRIPTION DRUG PAXIL CR paroxetine hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110101 NDA NDA020936 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE HEMIHYDRATE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 71335-0573_745e5efa-3d17-4978-8eff-01b0cc8c1f7f 71335-0573 HUMAN PRESCRIPTION DRUG Citalopram Citalopram Hydrobromide TABLET, FILM COATED ORAL 20041028 ANDA ANDA077031 Bryant Ranch Prepack CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 71335-0575_e4b28b72-9a8c-45d1-aa3a-8a559a6ac5e4 71335-0575 HUMAN OTC DRUG lansoprazole Lansoprazole CAPSULE, DELAYED RELEASE ORAL 20120807 ANDA ANDA202319 Bryant Ranch Prepack LANSOPRAZOLE 15 mg/1 N 20181231 71335-0576_7b2249a6-d565-47ec-95f3-c2bfb9e434ed 71335-0576 HUMAN PRESCRIPTION DRUG Lisinopril and Hydrochlorothiazide Lisinopril and Hydrochlorothiazide TABLET ORAL 20020702 ANDA ANDA076262 Bryant Ranch Prepack LISINOPRIL; HYDROCHLOROTHIAZIDE 20; 12.5 mg/1; mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 71335-0577_c34db5d7-775b-4733-bbbf-91a73314d6e0 71335-0577 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride phentermine hydrochloride CAPSULE ORAL 20150602 ANDA ANDA205019 Bryant Ranch Prepack PHENTERMINE HYDROCHLORIDE 30 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV N 20181231 71335-0578_bdcff5fb-9bc8-4b21-8167-db0f6fcfe252 71335-0578 HUMAN PRESCRIPTION DRUG fenofibrate fenofibrate TABLET ORAL 20140813 ANDA ANDA090715 Bryant Ranch Prepack FENOFIBRATE 48 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20181231 71335-0579_605ee03a-8916-4560-a82d-97e5c9011611 71335-0579 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride Diltiazem Hydrochloride TABLET ORAL 20101225 NDA AUTHORIZED GENERIC NDA018602 Bryant Ranch Prepack DILTIAZEM HYDROCHLORIDE 90 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] N 20181231 71335-0580_7f26916b-2d3d-4335-aadd-9c3b3989ee87 71335-0580 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin Sodium TABLET ORAL 20150714 ANDA ANDA040616 Bryant Ranch Prepack WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20191231 71335-0581_9fb9aa8a-f2ed-4678-acb0-fab0a44c9a70 71335-0581 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET ORAL 20121016 ANDA ANDA202928 Bryant Ranch Prepack CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 71335-0582_cb68c7b4-a287-407c-b53f-1e3fb56f387b 71335-0582 HUMAN PRESCRIPTION DRUG Donepezil Hydrochloride Donepezil Hydrochloride TABLET, FILM COATED ORAL 20110528 ANDA ANDA090686 Bryant Ranch Prepack DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 71335-0583_a7d7248c-8a78-42d9-bae2-e02dbb18fc9e 71335-0583 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20171116 ANDA ANDA205519 Bryant Ranch Prepack ATORVASTATIN CALCIUM 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 71335-0584_59100cf9-0aa2-4b8b-ba7f-48282094d46b 71335-0584 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET ORAL 20101008 ANDA ANDA090865 Bryant Ranch Prepack PRAMIPEXOLE DIHYDROCHLORIDE .5 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 71335-0585_ed34dd49-6611-4e7f-98e9-7292f10c1c3a 71335-0585 HUMAN PRESCRIPTION DRUG Ziprasidone Hydrochloride Ziprasidone Hydrochloride CAPSULE ORAL 20170218 ANDA ANDA204375 Bryant Ranch Prepack ZIPRASIDONE HYDROCHLORIDE 60 mg/1 Atypical Antipsychotic [EPC] N 20181231 71335-0587_75ae6b81-a46c-46ec-afa6-2718169b9ff7 71335-0587 HUMAN PRESCRIPTION DRUG ropinirole hydrochloride ropinirole hydrochloride TABLET, FILM COATED ORAL 20110920 ANDA ANDA078110 Bryant Ranch Prepack ROPINIROLE HYDROCHLORIDE .25 mg/1 Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] N 20181231 71335-0588_fd06fcce-18b1-44e7-950f-78bea965c0b5 71335-0588 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride dicyclomine hydrochloride CAPSULE ORAL 19991103 ANDA ANDA040319 Bryant Ranch Prepack DICYCLOMINE HYDROCHLORIDE 10 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20191231 71335-0590_4d5fabea-74ad-41d3-9ae0-014b13d83d03 71335-0590 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 Bryant Ranch Prepack GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20181231 71335-0591_be3f95b1-5184-4fd2-a51a-0c9bee2dda3d 71335-0591 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20091123 ANDA ANDA078558 Bryant Ranch Prepack IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0592_e96e7cbc-1c4b-4ef2-87dc-35a1826e5c0e 71335-0592 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET ORAL 20020129 ANDA ANDA075967 Bryant Ranch Prepack METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 71335-0593_b33a40c8-6801-48a7-85cc-5ee7e7fad321 71335-0593 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20150109 ANDA ANDA202801 Bryant Ranch Prepack LEVOFLOXACIN 750 mg/1 N 20191231 71335-0594_ca4af360-a90f-4842-b3f6-bdf614fe552a 71335-0594 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET, FILM COATED ORAL 20070406 ANDA ANDA086242 Bryant Ranch Prepack HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 71335-0595_300ffbf5-9682-404f-b4f5-d14458590bbe 71335-0595 HUMAN PRESCRIPTION DRUG bisoprolol fumarate and hydrochlorothiazide bisoprolol fumarate and hydrochlorothiazide TABLET ORAL 20101012 ANDA ANDA079106 Bryant Ranch Prepack HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE 6.25; 5 mg/1; mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0596_9d12772f-a6f7-4269-8253-9db5b04544be 71335-0596 HUMAN OTC DRUG Magnesium Oxide Magnesium Oxide TABLET ORAL 20150908 OTC MONOGRAPH FINAL part331 Bryant Ranch Prepack MAGNESIUM OXIDE 400 mg/1 N 20181231 71335-0597_7b5fa1a4-358d-4c9a-b575-61f2bdda5ca4 71335-0597 HUMAN PRESCRIPTION DRUG Celecoxib Celecoxib CAPSULE ORAL 20150312 ANDA ANDA200562 Bryant Ranch Prepack CELECOXIB 200 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 71335-0598_ecff2413-0721-4be3-9980-c2e817796356 71335-0598 HUMAN PRESCRIPTION DRUG Eszopiclone Eszopiclone TABLET, FILM COATED ORAL 20140425 ANDA ANDA202929 Bryant Ranch Prepack ESZOPICLONE 1 mg/1 CIV N 20191231 71335-0599_2fbf1174-1b16-4aac-a5d5-22165477fc1c 71335-0599 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 19870109 ANDA ANDA071450 Bryant Ranch Prepack ALLOPURINOL 300 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] N 20181231 71335-0600_8ece88b2-f6e5-4c30-894f-71bc7cc7ad6f 71335-0600 HUMAN PRESCRIPTION DRUG Valsartan Valsartan TABLET, FILM COATED ORAL 20150105 ANDA ANDA090642 Bryant Ranch Prepack VALSARTAN 320 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 71335-0601_02664c90-3a5b-48cf-b5a5-a967414af14f 71335-0601 HUMAN PRESCRIPTION DRUG Furosemide furosemide TABLET ORAL 19810827 NDA NDA018487 Bryant Ranch Prepack FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] N 20191231 71335-0602_f8bc5c60-45f4-4fa1-a7ca-dc6c3a90677d 71335-0602 HUMAN PRESCRIPTION DRUG Etodolac Etodolac TABLET, COATED ORAL 20150420 ANDA ANDA074903 Bryant Ranch Prepack ETODOLAC 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 71335-0603_539a7333-72f1-485b-90f2-715a48db308e 71335-0603 HUMAN PRESCRIPTION DRUG Paroxetine paroxetine hydrochloride hemihydrate TABLET, FILM COATED ORAL 20141101 ANDA ANDA203854 Bryant Ranch Prepack PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 71335-0604_3bff2db9-ce41-4418-8328-42f80b16e383 71335-0604 HUMAN PRESCRIPTION DRUG Fentanyl Fentanyl PATCH TRANSDERMAL 20070820 ANDA ANDA077062 Bryant Ranch Prepack FENTANYL 100 ug/h Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 71335-0605_934d081b-dc42-4c26-8012-a0a5452b1536 71335-0605 HUMAN PRESCRIPTION DRUG Morphine sulfate Morphine sulfate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20151026 ANDA ANDA203849 Bryant Ranch Prepack MORPHINE SULFATE 30 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20191231 71335-0606_e18cf0ea-f913-412e-9f9d-018b2c056a22 71335-0606 HUMAN PRESCRIPTION DRUG Rosuvastatin calcium Rosuvastatin calcium TABLET, FILM COATED ORAL 20161031 ANDA ANDA206434 Bryant Ranch Prepack ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 71335-0607_544a350d-b83b-4d1f-bf32-decc8364d513 71335-0607 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol Tartrate TABLET, FILM COATED ORAL 20070911 ANDA ANDA077739 Bryant Ranch Prepack METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20191231 71335-0608_46b15ff4-5196-46a4-9739-eeced620beba 71335-0608 HUMAN OTC DRUG Aspirin Low Dose Safety Coated Aspirin TABLET, COATED ORAL 20130315 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ASPIRIN 81 mg/1 N 20181231 71335-0609_afee7a20-e7de-4773-b5d6-fbefe63cb4f7 71335-0609 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20160620 ANDA ANDA204838 Bryant Ranch Prepack ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 71335-0610_1e6a996d-3967-43d6-80df-bd6615afc0d7 71335-0610 HUMAN PRESCRIPTION DRUG oxybutynin chloride oxybutynin chloride TABLET, EXTENDED RELEASE ORAL 20161220 ANDA ANDA207138 Bryant Ranch Prepack OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 71335-0611_ab9d3bbd-f6e9-48ed-b829-0672c8845bc8 71335-0611 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA078723 Bryant Ranch Prepack MONTELUKAST SODIUM 5 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20181231 71335-0612_5fb9fc2e-16f2-4c49-8e38-98d3f2a373ef 71335-0612 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride Bupropion Hydrochloride TABLET, EXTENDED RELEASE ORAL 20040322 ANDA ANDA075932 Bryant Ranch Prepack BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 71335-0613_5907c4e9-b330-4aac-b819-10ad90e678b8 71335-0613 HUMAN PRESCRIPTION DRUG FOLIC ACID folic acid TABLET ORAL 20150804 ANDA ANDA204418 Bryant Ranch Prepack FOLIC ACID 1 mg/1 N 20181231 71335-0614_ad3e799c-4bf9-4f1a-92d2-f996a865cfe3 71335-0614 HUMAN OTC DRUG mapap arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20060216 ANDA ANDA075077 Bryant Ranch Prepack ACETAMINOPHEN 650 mg/1 N 20181231 71335-0615_f00609d6-41d3-4132-96f5-96a2dfeaa6f3 71335-0615 HUMAN OTC DRUG Meclizine HCL 12.5 mg Meclizine HCL 12.5 mg TABLET ORAL 20151101 OTC MONOGRAPH FINAL part336 Bryant Ranch Prepack MECLIZINE HYDROCHLORIDE 12.5 mg/1 N 20191231 71335-0616_529b1e30-0725-404e-b6cf-3b6c86b09103 71335-0616 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20160803 ANDA ANDA071134 Bryant Ranch Prepack DIAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20191231 71335-0617_dc956621-1599-44aa-8000-26575ebdd70b 71335-0617 HUMAN PRESCRIPTION DRUG Oxaprozin Oxaprozin TABLET ORAL 20170504 ANDA ANDA208633 Bryant Ranch Prepack OXAPROZIN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71335-0618_dc02f761-7274-4988-8f04-2694689cedc5 71335-0618 HUMAN PRESCRIPTION DRUG Glipizide Glipizide TABLET ORAL 20020925 ANDA ANDA075795 Bryant Ranch Prepack GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] N 20191231 71335-0619_23a89d1b-624a-4ca1-8824-fabb83f56b38 71335-0619 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride and Acetaminophen Tramadol Hydrochloride and Acetaminophen TABLET, FILM COATED ORAL 20121015 ANDA ANDA090460 Bryant Ranch Prepack ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325; 37.5 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 71335-0620_73eda5e0-cbe3-452c-bda4-78ba0bcc2365 71335-0620 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, CHEWABLE ORAL 20120803 ANDA ANDA090984 Bryant Ranch Prepack MONTELUKAST SODIUM 4 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 71335-0621_32547eae-be4d-4604-acb0-a7a6c4707b8b 71335-0621 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20141008 ANDA ANDA201658 Bryant Ranch Prepack CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 71335-0622_2d80908c-867c-4dc3-a680-40ad1e91132f 71335-0622 HUMAN OTC DRUG Aspirin Low Dose Aspirin TABLET, COATED ORAL 20110501 OTC MONOGRAPH NOT FINAL part343 Bryant Ranch Prepack ASPIRIN 81 mg/1 N 20181231 71335-0623_26c7dece-1be2-496f-a056-d0a3a2db172f 71335-0623 HUMAN PRESCRIPTION DRUG Prednisone Prednisone TABLET ORAL 20010829 ANDA ANDA040362 Bryant Ranch Prepack PREDNISONE 20 mg/1 N 20191231 71335-0624_cb9f7d00-9711-45b2-9d28-33066c259d5c 71335-0624 HUMAN PRESCRIPTION DRUG CHLORTHALIDONE CHLORTHALIDONE TABLET ORAL 20170517 ANDA ANDA206904 Bryant Ranch Prepack CHLORTHALIDONE 25 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 71335-0625_6e116ede-5bfe-4368-bd5d-baf21895668c 71335-0625 HUMAN OTC DRUG Sunmark pain reliever Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20170530 ANDA ANDA075077 Bryant Ranch Prepack ACETAMINOPHEN 650 mg/1 N 20181231 71338-119_4c70dcea-3d8b-5b31-e054-00144ff88e88 71338-119 HUMAN OTC DRUG ECOLAB Eye Wash Purified Water LIQUID OPHTHALMIC 20170329 OTC MONOGRAPH FINAL part349 ECOLAB Food Safety Specialties, Inc. WATER .983 mg/mL N 20181231 71338-121_4aef8f98-db77-07f2-e054-00144ff8d46c 71338-121 HUMAN OTC DRUG Ecolab Triple Antibiotic Bacitracin, Neomycin Sulfate, Polymyxin B Sulfate OINTMENT TOPICAL 20170320 OTC MONOGRAPH FINAL part333B Ecolabs Food Safety Specialties, Inc. NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC 3.5; 5000; 400 mg/g; [USP'U]/g; [USP'U]/g N 20181231 71338-122_4c982e7b-248a-151f-e054-00144ff88e88 71338-122 HUMAN OTC DRUG ECOLAB Antiseptic Benzalkonium Chloride 0.13% SPRAY TOPICAL 20170407 OTC MONOGRAPH NOT FINAL part333A ECOLAB Food Safety and Specialties, Inc. BENZALKONIUM CHLORIDE 1.3 g/L N 20181231 71338-123_4b2a7da9-c0ea-61c5-e054-00144ff8d46c 71338-123 HUMAN OTC DRUG ECOLAB Burn Cream Benzaalkonium chloride, Lidocaine HCl CREAM TOPICAL 20170320 OTC MONOGRAPH NOT FINAL part333A ECOLAB Food Safety Specialties, Inc. BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 5 mg/g; mg/g N 20181231 71338-124_4c430aff-7f89-5529-e054-00144ff8d46c 71338-124 HUMAN OTC DRUG ECOLAB Hand Sanitizer Ethyl Alcohol 66.5% GEL TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part333E ECOLAB Food Safety Specialties, Inc. ALCOHOL 540.26 g/L N 20181231 71338-125_4c45c2e7-e4b6-0a93-e054-00144ff8d46c 71338-125 HUMAN OTC DRUG ECOLAB Antiseptic Benzalkonium Chloride 0.13% LIQUID TOPICAL 20170403 OTC MONOGRAPH NOT FINAL part333E ECOLAB Food Safety Specialties, Inc. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 71338-137_4bcc2415-2409-6f29-e054-00144ff8d46c 71338-137 HUMAN OTC DRUG ECOLAB Blood Clotting Bezethonium Chloride, Lidocaine AEROSOL, SPRAY TOPICAL 20170328 OTC MONOGRAPH NOT FINAL part348 ECOLAB Food Safety Specialties, Inc. LIDOCAINE; BENZETHONIUM CHLORIDE 3400; 170 mg/85g; mg/85g N 20181231 71338-138_4b6addc3-1616-1e33-e054-00144ff8d46c 71338-138 HUMAN OTC DRUG ECOLAB Burn Lidocaine HCl 2.0% SPRAY TOPICAL 20170323 OTC MONOGRAPH NOT FINAL part348 ECOLAB Food Safety Specialists, Inc. LIDOCAINE HYDROCHLORIDE 20 mg/mL N 20181231 71338-140_4b663e5a-a472-269a-e054-00144ff8d46c 71338-140 HUMAN OTC DRUG ECOLAB Isopropyl Alcohol Isopropyl Alcohol SPRAY TOPICAL 20170323 OTC MONOGRAPH NOT FINAL part333A ECOLAB Food Safety Specialties, Inc. ISOPROPYL ALCOHOL 700 mL/L N 20181231 71338-141_4b681c29-c0a0-0649-e054-00144ff8d46c 71338-141 HUMAN OTC DRUG ECOLAB Hydrogen Peroxide Hydrogen Peroxide 3.0% SPRAY TOPICAL 20170323 OTC MONOGRAPH NOT FINAL part333A ECOLAB Food Safety Specialties, Inc. HYDROGEN PEROXIDE 30 mL/L N 20181231 71338-144_4b2f903a-6690-353a-e054-00144ff88e88 71338-144 HUMAN OTC DRUG ECOLAB Hydrocortisone Cream Hydrocortisone 1.0% CREAM TOPICAL 20170320 OTC MONOGRAPH NOT FINAL part348 ECOLAB Food Safety Specialties, Inc. HYDROCORTISONE 10 mg/g N 20181231 71339-010_dc4e23ba-9b28-4e94-9fab-c3fb0ad552b8 71339-010 HUMAN OTC DRUG JENACELL SUPERCELL SERUM GLYCERIN, ALLANTOIN, HYDROXYETHYL CELLULOSE LIQUID TOPICAL 20170301 UNAPPROVED DRUG OTHER Functionfive Inc. GLYCERIN; ALLANTOIN; HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) .14; .006; .018 g/2mL; g/2mL; g/2mL N 20181231 71342-0001_4b5c57de-3502-3639-e054-00144ff88e88 71342-0001 HUMAN OTC DRUG DR. GLODERM TIME TO LIFTUP MASK Niacinamide, Adenosine LIQUID TOPICAL 20170301 UNAPPROVED DRUG OTHER DR.GLODERM ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71342-0002_4b5f3e21-e590-6f76-e054-00144ff8d46c 71342-0002 HUMAN OTC DRUG DR. GLODERM TIME TO MOISTURE MASK GLYCERIN LIQUID TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 5.006 g/100mL N 20181231 71342-0003_4b5dd7b0-0ebe-7076-e054-00144ff88e88 71342-0003 HUMAN OTC DRUG DR. GLODERM TIME TO WHITENING MASK Niacinamide LIQUID TOPICAL 20170301 UNAPPROVED DRUG OTHER DR.GLODERM NIACINAMIDE 2 g/100mL N 20181231 71342-0004_4b5f3e21-e5b4-6f76-e054-00144ff8d46c 71342-0004 HUMAN OTC DRUG DR. GLODERM TIME TO WRINKLETOX MASK Adenosine LIQUID TOPICAL 20170301 UNAPPROVED DRUG OTHER DR.GLODERM ADENOSINE .04 g/100mL N 20181231 71342-0005_4c000bd1-0b8d-52ad-e054-00144ff8d46c 71342-0005 HUMAN OTC DRUG DR. GLODERM TABRX MOISTURE MASK Glycerin KIT TOPICAL 20170327 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM N 20181231 71342-0006_4baf87c4-cf80-0fc9-e054-00144ff88e88 71342-0006 HUMAN OTC DRUG DR. GLODERM TABRX LIFTUP MASK Niacinamide, Adenosine KIT TOPICAL 20170327 UNAPPROVED DRUG OTHER DR.GLODERM N 20181231 71342-0007_4bae1606-67c8-443b-e054-00144ff88e88 71342-0007 HUMAN OTC DRUG DR. GLODERM TABRX WHITENING MASK Niacinamide KIT TOPICAL 20170323 UNAPPROVED DRUG OTHER DR.GLODERM N 20181231 71342-0008_4bae1606-67dd-443b-e054-00144ff88e88 71342-0008 HUMAN OTC DRUG DR. GLODERM TABRX WRINKLETOX MASK Adenosine KIT TOPICAL 20170323 UNAPPROVED DRUG OTHER DR.GLODERM N 20181231 71342-0010_4bc38f3f-1ac0-48d5-e054-00144ff8d46c 71342-0010 HUMAN OTC DRUG DR. GLODERM TABRX LIFTUP Niacinamide, Adenosine CREAM TOPICAL 20170301 UNAPPROVED DRUG OTHER DR.GLODERM ADENOSINE; NIACINAMIDE .04; 2.14 g/100g; g/100g N 20181231 71342-0012_4bc34412-6fc1-3d8f-e054-00144ff8d46c 71342-0012 HUMAN OTC DRUG DR. GLODERM TABRX WHITENING Niacinamide CREAM TOPICAL 20170301 UNAPPROVED DRUG OTHER DR.GLODERM NIACINAMIDE 2.14 g/100g N 20181231 71342-0013_4bc38f3f-1ad3-48d5-e054-00144ff8d46c 71342-0013 HUMAN OTC DRUG DR. GLODERM TABRX WRINKLETOX Adenosine CREAM TOPICAL 20170301 UNAPPROVED DRUG OTHER DR.GLODERM ADENOSINE .0428 g/100g N 20181231 71342-0014_4c000bd1-0b8f-52ad-e054-00144ff8d46c 71342-0014 HUMAN OTC DRUG DR. GLODERM TABRX MOISTURE Glycerin CREAM TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 1.729 g/100g N 20181231 71342-0015_624bd489-3a4f-3220-e053-2a91aa0a6371 71342-0015 HUMAN OTC DRUG OERBEUA NOURISHING MASK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 4.975 g/100mL N 20191231 71342-0016_624d6439-9ebc-2614-e053-2a91aa0aa606 71342-0016 HUMAN OTC DRUG OERBEUA RADIANT MASK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 4.975 g/100mL N 20191231 71342-0017_624df6f1-292c-c7af-e053-2a91aa0a105c 71342-0017 HUMAN OTC DRUG OERBEUA MOISTURE MASK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 4.975 g/100mL N 20191231 71342-0018_624e2a34-35a7-5cf8-e053-2a91aa0af748 71342-0018 HUMAN OTC DRUG OERBEUA CALMING MASK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 4.975 g/100mL N 20191231 71342-0019_624e2a34-35b1-5cf8-e053-2a91aa0af748 71342-0019 HUMAN OTC DRUG OERBEUA CLEARING MASK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 4.975 g/100mL N 20191231 71342-0020_624e8883-4d32-5005-e053-2991aa0aaafb 71342-0020 HUMAN OTC DRUG OERBEUA FIRMING MASK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 4.975 g/100mL N 20191231 71342-0021_624f2db1-b86d-6536-e053-2991aa0adb49 71342-0021 HUMAN OTC DRUG OERBEUA MATTIFYING MASK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 4.975 g/100mL N 20191231 71342-0022_625036b4-1c2a-1b39-e053-2991aa0ae5e2 71342-0022 HUMAN OTC DRUG OERBEUA SHINING MASK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 4.975 g/100mL N 20191231 71342-0023_625036b4-1c38-1b39-e053-2991aa0ae5e2 71342-0023 HUMAN OTC DRUG OERBEUA SOOTHING MASK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 4.975 g/100mL N 20191231 71342-0024_6250d0c6-d990-1753-e053-2a91aa0a23a2 71342-0024 HUMAN OTC DRUG OERBEUA SMOOTHING MASK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 4.975 g/100mL N 20191231 71342-0025_625111fa-08ae-a2be-e053-2a91aa0adbf3 71342-0025 HUMAN OTC DRUG OERBEUA ENERGIZING MASK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 4.975 g/100mL N 20191231 71342-0026_6252e095-9563-8ae2-e053-2a91aa0af44b 71342-0026 HUMAN OTC DRUG OERBEUA HYDRATING MASK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 4.975 g/100mL N 20191231 71342-0027_626a0288-ba73-e55e-e053-2a91aa0ab9f8 71342-0027 HUMAN OTC DRUG OERBEUA PURIFYING CLEANSER FOAM Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 19.91 g/100g N 20191231 71342-0028_626a0288-ba79-e55e-e053-2a91aa0ab9f8 71342-0028 HUMAN OTC DRUG OERBEUA HEATING PORE CRAY PACK Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 DR.GLODERM GLYCERIN 10.5 g/100g N 20191231 71344-002_4c6ea86f-adb1-3dc7-e054-00144ff8d46c 71344-002 HUMAN OTC DRUG Cold-Fix Affinity Purified Antibodies to Human Gamma Interferon TABLET ORAL 20170327 UNAPPROVED HOMEOPATHIC Seme USA Inc INTERFERON-.GAMMA. 12 [hp_C]/1 N 20181231 71344-003_4c6e5c07-bb24-6f0a-e054-00144ff88e88 71344-003 HUMAN OTC DRUG Cold-Fix (for Children) Affinity Purified Antibodies to Human Gamma Interferon TABLET ORAL 20170327 UNAPPROVED HOMEOPATHIC Seme USA Inc INTERFERON-.GAMMA. 12 [hp_C]/1 N 20181231 71346-010_dfbb9058-80ef-4d9e-934b-879fe45e1545 71346-010 HUMAN OTC DRUG THE OOZOO FACE GOLD FOILAYER MASK Adenosine PATCH TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd ADENOSINE .01 g/25mL N 20181231 71346-020_ba412880-83ea-4ff7-86e0-13677e6a44d6 71346-020 HUMAN OTC DRUG THE OOZOO FACE SILVER FOILAYER MASK Adenosine PATCH TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd ADENOSINE .01 g/25mL N 20181231 71346-030_7a6cdb72-bd39-478c-82bf-1df2d6f1eeb1 71346-030 HUMAN OTC DRUG THE OOZOO OOZOO BEAR AURORA ILLUMINATING AMPOULE Adenosine LIQUID TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd ADENOSINE .001 g/3mL N 20181231 71346-040_9a39014d-22e8-4c7f-b29f-3865710799e1 71346-040 HUMAN OTC DRUG THE OOZOO OOZOO BEAR AURORA ILLUMINATING MASK Adenosine PATCH TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd ADENOSINE .009 g/24mL N 20181231 71346-050_6247964d-c235-4440-aa03-1a74f1b3fe19 71346-050 HUMAN OTC DRUG THE OOZOO OOZOO BEAR WATER BANG HYDRATING AMPOULE Adenosine LIQUID TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd ADENOSINE .001 g/3mL N 20181231 71346-060_4bd5f130-d211-4b0d-9074-87b7d9d49baa 71346-060 HUMAN OTC DRUG THE OOZOO OOZOO BEAR WATER BANG HYDRATING MASK Adenosine PATCH TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd ADENOSINE .008 g/20mL N 20181231 71346-070_1991b1d3-b7f9-4357-858b-52e43c835bb6 71346-070 HUMAN OTC DRUG THE OOZOO OOZOO BEAR BLACK SPACE PORE CARING AMPOULE Adenosine LIQUID TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd ADENOSINE .001 g/3mL N 20181231 71346-080_6a50d782-79c1-4ae1-b16c-f0b40da61c88 71346-080 HUMAN OTC DRUG THE OOZOO OOZOO BEAR BLACK SPACE PORE CARING MASK Adenosine PATCH TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd ADENOSINE .009 g/24mL N 20181231 71346-090_06fdda06-78ab-4cb5-80dd-e688c7efebf8 71346-090 HUMAN OTC DRUG THE OOZOO RECOVERY CAP SULE ACTIVATOR Adenosine LIQUID TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd ADENOSINE .001 g/4mL N 20181231 71346-100_7b5b6704-9357-4c7f-bfe6-0799947b0f27 71346-100 HUMAN OTC DRUG THE OOZOO RECOVERY MASK Adenosine PATCH TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd ADENOSINE .008 g/20mL N 20181231 71346-110_522d4232-c5f6-4d7e-9a73-ee6a53253143 71346-110 HUMAN OTC DRUG THE OOZOO LIGHTENING CAP SULE ACTIVATOR Adenosine LIQUID TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd ADENOSINE .001 g/4mL N 20181231 71346-120_c7883c07-a60f-482e-8209-c5eb7a36928f 71346-120 HUMAN OTC DRUG THE OOZOO LIGHTENING MASK Adenosine PATCH TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd ADENOSINE .008 g/20mL N 20181231 71346-130_cafd7f5f-60b7-4342-b785-9191ddea992f 71346-130 HUMAN OTC DRUG THE OOZOO FACE ENERGY SHOT PREMIUM BLACK AMPOULE1 Niacinamide, Adenosine LIQUID TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd NIACINAMIDE; ADENOSINE .006; .0001 g/.3mL; g/.3mL N 20181231 71346-140_6ac3c446-a53f-4913-a22d-6b28e462f3a2 71346-140 HUMAN OTC DRUG THE OOZOO FACE ENERGY SHOT PREMIUM BLACK AMPOULE2 Niacinamide, Adenosine LIQUID TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd NIACINAMIDE; ADENOSINE .054; .001 g/2.7mL; g/2.7mL N 20181231 71346-150_170d1d9d-2a66-428f-bc47-16dec47588bf 71346-150 HUMAN OTC DRUG THE OOZOO FACE ENERGY SHOT PREMIUM BLACK MASK Niacinamide, Adenosine PATCH TOPICAL 20170315 UNAPPROVED DRUG OTHER THE OOZOO Co. Ltd NIACINAMIDE; ADENOSINE .6; .012 g/30mL; g/30mL N 20181231 71347-100_0c5520d9-baeb-4813-8491-9f39c54a6e9f 71347-100 HUMAN OTC DRUG Advance Topical Anesthetic Gel Benzocaine GEL DENTAL 20170301 OTC MONOGRAPH NOT FINAL part356 The Atlanta Dental Supply Company DBA Advanced Dental Products BENZOCAINE 200 mg/g N 20181231 71347-101_71bca2ce-6476-491e-8ac1-7fccfa74c87c 71347-101 HUMAN OTC DRUG Advance Topical Anesthetic Gel Benzocaine GEL DENTAL 20170301 OTC MONOGRAPH NOT FINAL part356 The Atlanta Dental Supply Company DBA Advanced Dental Products BENZOCAINE 200 mg/g N 20181231 71347-102_e43caa89-027f-4d5b-ab06-4bfc90c586af 71347-102 HUMAN OTC DRUG Advance Topical Anesthetic Gel Benzocaine GEL DENTAL 20170301 OTC MONOGRAPH NOT FINAL part356 The Atlanta Dental Supply Company DBA Advanced Dental Products BENZOCAINE 200 mg/g N 20181231 71347-103_a30b5c44-f1ea-4ee0-b761-d6223f7de879 71347-103 HUMAN OTC DRUG Advance Topical Anesthetic Gel Benzocaine GEL DENTAL 20170301 OTC MONOGRAPH NOT FINAL part356 The Atlanta Dental Supply Company DBA Advanced Dental Products BENZOCAINE 200 mg/g N 20181231 71347-104_b8122ebf-0930-492f-b267-f58d52c6fc3c 71347-104 HUMAN OTC DRUG Advance Topical Anesthetic Gel Benzocaine GEL DENTAL 20170301 OTC MONOGRAPH NOT FINAL part356 The Atlanta Dental Supply Company DBA Advanced Dental Products BENZOCAINE 200 mg/g N 20181231 71347-105_adc36c7e-31f4-48d4-8f95-705db6ee555e 71347-105 HUMAN OTC DRUG Advance Topical Anesthetic Gel Benzocaine GEL DENTAL 20170301 OTC MONOGRAPH NOT FINAL part356 The Atlanta Dental Supply Company DBA Advanced Dental Products BENZOCAINE 200 mg/g N 20181231 71352-0101_4b656531-408a-285c-e054-00144ff88e88 71352-0101 HUMAN OTC DRUG Kinkly Personal Lubricant Personal Lubricant OIL CUTANEOUS; EXTRACORPOREAL; VAGINAL 20170323 UNAPPROVED DRUG OTHER Shenzhen Beston E-Commerce Co., Ltd. BUTYLENE GLYCOL 48 g/240mL N 20191231 71352-0101_5f7f1885-0bf0-08bc-e053-2991aa0af06a 71352-0101 HUMAN OTC DRUG Kinkly Personal Lubricant Personal Lubricant OIL CUTANEOUS; EXTRACORPOREAL; VAGINAL 20171204 UNAPPROVED DRUG OTHER Shenzhen Beston E-Commerce Co., Ltd. BUTYLENE GLYCOL 60 g/300mL N 20191231 71352-0101_635b288e-937a-67ea-e053-2a91aa0afc0f 71352-0101 HUMAN OTC DRUG Kinkly Personal Lubricant Personal Lubricant OIL CUTANEOUS; EXTRACORPOREAL; VAGINAL 20180123 UNAPPROVED DRUG OTHER Shenzhen Beston E-Commerce Co., Ltd. BUTYLENE GLYCOL 5 g/25mL N 20191231 71353-0001_4bd62945-d976-082b-e054-00144ff8d46c 71353-0001 HUMAN OTC DRUG ADD MORE HAIR SALICYLIC ACID, PANTHENOL, ZINC PYRITHIONE SHAMPOO TOPICAL 20170301 UNAPPROVED DRUG OTHER Myung Sung Co., Ltd. SALICYLIC ACID; PANTHENOL; PYRITHIONE ZINC .2; .5; .29 g/100mL; g/100mL; g/100mL N 20181231 71355-819_4bccc017-2670-11ce-e054-00144ff8d46c 71355-819 HUMAN OTC DRUG Pure Haven Essentials TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170328 OTC MONOGRAPH NOT FINAL part352 Pure Haven LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71356-818_4bccc017-264f-11ce-e054-00144ff8d46c 71356-818 HUMAN OTC DRUG Human Science Muscle Pain Relief METHYL SALICYLATE, MENTHOL CREAM TOPICAL 20170328 OTC MONOGRAPH NOT FINAL part348 Human Science, LLC METHYL SALICYLATE; MENTHOL 100; 100 mg/mL; mg/mL N 20181231 71358-011_56191aba-7e86-220a-e054-00144ff88e88 71358-011 HUMAN OTC DRUG Viniferamine Renewal Moisturizer Dimethicone CREAM TOPICAL 20140123 OTC MONOGRAPH FINAL part347 McCord Research DIMETHICONE 15 mg/g N 20181231 71358-012_56191aba-7e86-220a-e054-00144ff88e88 71358-012 HUMAN OTC DRUG Viniferamine SkinMineralZ Zinc Oxide PASTE TOPICAL 20140123 OTC MONOGRAPH FINAL part347 McCord Research ZINC OXIDE 125 mg/g N 20181231 71358-014_56191aba-7e86-220a-e054-00144ff88e88 71358-014 HUMAN OTC DRUG Viniferamine Clean N Moist Dimethicone LOTION TOPICAL 20140123 OTC MONOGRAPH FINAL part347 McCord Research DIMETHICONE 15 mg/mL N 20181231 71358-015_56191aba-7e86-220a-e054-00144ff88e88 71358-015 HUMAN OTC DRUG Viniferamine Antiseptic Cleanser Benzalkonium Chloride SPRAY TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part333A McCord Research BENZALKONIUM CHLORIDE 1.2 mg/mL N 20181231 71358-066_56191aba-7e86-220a-e054-00144ff88e88 71358-066 HUMAN OTC DRUG Viniferamine Silicone Barrier Dimethicone CREAM TOPICAL 20140123 OTC MONOGRAPH FINAL part347 McCord Research DIMETHICONE 25 mg/g N 20181231 71358-077_56191aba-7e86-220a-e054-00144ff88e88 71358-077 HUMAN OTC DRUG Viniferamine Antifungal Cream Miconazole Nitrate CREAM TOPICAL 20140123 OTC MONOGRAPH FINAL part333C McCord Research MICONAZOLE NITRATE 20 mg/g N 20181231 71358-080_56191aba-7e86-220a-e054-00144ff88e88 71358-080 HUMAN OTC DRUG Viniferamine Hydrocortisone Cream Hydrocortisone CREAM TOPICAL 20140123 OTC MONOGRAPH NOT FINAL part348 McCord Research HYDROCORTISONE 10 mg/g N 20181231 71363-100_20071470-44e5-43d8-9367-447737232dc0 71363-100 HUMAN OTC DRUG Astra-dent Topical Anesthetic Gel Benzocaine GEL DENTAL 20160701 OTC MONOGRAPH NOT FINAL part356 Zag Usa Inc BENZOCAINE 200 mg/g N 20181231 71363-101_7e24d0ab-c217-4ae3-90c2-074467ebba99 71363-101 HUMAN OTC DRUG Astra-dent Topical Anesthetic Gel Benzocaine GEL DENTAL 20160701 OTC MONOGRAPH NOT FINAL part356 Zag Usa Inc BENZOCAINE 200 mg/g N 20181231 71363-102_1d9fa9df-b627-4a91-8f30-e642f878d2da 71363-102 HUMAN OTC DRUG Astra-dent Topical Anesthetic Gel Benzocaine GEL DENTAL 20160701 OTC MONOGRAPH NOT FINAL part356 Zag Usa Inc BENZOCAINE 200 mg/g N 20181231 71363-103_1ac9ee05-e87f-4357-8dd4-2fa6fbbbb1c8 71363-103 HUMAN OTC DRUG Astra-dent Topical Anesthetic Gel Benzocaine GEL DENTAL 20160701 OTC MONOGRAPH NOT FINAL part356 Zag Usa Inc BENZOCAINE 200 mg/g N 20181231 71363-104_628f481d-625e-44c8-9e3a-f9d87029c96a 71363-104 HUMAN OTC DRUG Astra-dent Topical Anesthetic Gel Benzocaine GEL DENTAL 20160701 OTC MONOGRAPH NOT FINAL part356 Zag Usa Inc BENZOCAINE 200 mg/g N 20181231 71363-105_364bc68d-b828-464c-bd72-2d88064bd7dc 71363-105 HUMAN OTC DRUG Astra-dent Topical Anesthetic Gel Benzocaine GEL DENTAL 20160701 OTC MONOGRAPH NOT FINAL part356 Zag Usa Inc BENZOCAINE 200 mg/g N 20181231 71363-106_98a427c0-6d72-4906-a0af-c5cf823c4aa2 71363-106 HUMAN OTC DRUG Astra-dent Topical Anesthetic Gel Benzocaine GEL DENTAL 20160701 OTC MONOGRAPH NOT FINAL part356 Zag Usa Inc BENZOCAINE 200 mg/g N 20181231 71363-107_5e00b3d8-bad1-439a-a733-d9a19dac89d6 71363-107 HUMAN OTC DRUG Astra-dent Topical Anesthetic Gel Benzocaine GEL DENTAL 20160701 OTC MONOGRAPH NOT FINAL part356 Zag Usa Inc BENZOCAINE 200 mg/g N 20181231 71367-010_6725b42b-e620-442f-b2cc-a1dd6e4b2eb6 71367-010 HUMAN OTC DRUG Dr LeE UV ICE SHIELD Titanium Dioxide, Octinoxate, Zinc Oxide, Octisalate CREAM TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 DRLEECOSMETIC TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE; OCTISALATE 2.85; 2.14; 1.61; 1.43 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 71370-100_5008b888-f784-356e-e054-00144ff88e88 71370-100 HUMAN OTC DRUG PH Simply Hand and Skin Sanitizer Benzalkonium chloride SPRAY TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part333A Paris Honore, LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 71371-001_95808b21-d104-46ed-8585-08e8d54bf478 71371-001 HUMAN OTC DRUG Organic Sunscreen Zinc Oxide CREAM TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part352 NATURE'S NATURAL PRODUCTS, INC ZINC OXIDE 20 g/100mL N 20181231 71372-001_4c6c2afd-17c3-2615-e054-00144ff8d46c 71372-001 HUMAN OTC DRUG Coconut Anti Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part333E B2 Fashions Inc. ALCOHOL 620 mg/mL N 20181231 71372-002_4c6c1a2a-ceeb-280e-e054-00144ff8d46c 71372-002 HUMAN OTC DRUG Apple Anti Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part333E B2 Fashions Inc. ALCOHOL 620 mg/mL N 20181231 71372-003_4c6c1a2a-cf01-280e-e054-00144ff8d46c 71372-003 HUMAN OTC DRUG Mix Berries Anti Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part333E B2 Fashions Inc. ALCOHOL 620 mg/mL N 20181231 71372-004_4c6c7b25-b8a1-483a-e054-00144ff8d46c 71372-004 HUMAN OTC DRUG Watermelon Anti Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part333E B2 Fashions Inc. ALCOHOL 620 mg/mL N 20181231 71372-005_4c6c7b25-b8b0-483a-e054-00144ff8d46c 71372-005 HUMAN OTC DRUG Regular Anti Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20170405 OTC MONOGRAPH NOT FINAL part333E B2 Fashions Inc. ALCOHOL 620 mg/mL N 20181231 71375-101_5e48cb13-69f2-410a-8523-926af6d8fd01 71375-101 HUMAN OTC DRUG CLEARX 3 BLEMISH CREME BENZOYL PEROXIDE CREAM TOPICAL 20170930 OTC MONOGRAPH FINAL part333D CRDG ENTERPRISES INC BENZOYL PEROXIDE 10 g/100mL N 20181231 71377-0001_0853670a-0b2f-430d-8297-db3cadb1f27f 71377-0001 HUMAN OTC DRUG Psorent Psoriasis Coal Tar LIQUID TOPICAL 20170815 OTC MONOGRAPH FINAL part358H TriStrata, Inc. COAL TAR 23 mg/mL N 20181231 71379-010_d4223326-1cb0-44f7-b104-86369b21f23d 71379-010 HUMAN OTC DRUG LAPCOS Fresh Daily Sun Octinoxate, Octisalate CREAM TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 LAP CO.,LTD OCTINOXATE; OCTISALATE 3.5; 2.25 g/50mL; g/50mL N 20181231 71379-020_1c7f8092-e26b-4664-bb1e-25c82fa00786 71379-020 HUMAN OTC DRUG LAPCOS Lasting Waterproof Sun Octinoxate, Octisalate, Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 LAP CO.,LTD OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 3.5; 2.5; 2.4; 1.45 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 71379-030_fac78e0e-4020-48cc-b470-a3e7fc2214d9 71379-030 HUMAN OTC DRUG LAPCOS Doublet Cover Cushion 01 Rosy Ivory Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 LAP CO.,LTD TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.64; .8; .48 g/12g; g/12g; g/12g N 20181231 71379-040_49551729-6e33-4632-b35f-bfe714ee91af 71379-040 HUMAN OTC DRUG LAPCOS Doublet Cover Cushion 02 Neutral Beige Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 LAP CO.,LTD TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.64; .8; .48 g/12g; g/12g; g/12g N 20181231 71379-050_d7d5fc24-b26f-4006-a526-fdc1c8ea30d6 71379-050 HUMAN OTC DRUG LAPCOS Stay With Me Cushion 01 Rosy Ivory Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 LAP CO.,LTD TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.52; .8; .48 g/12g; g/12g; g/12g N 20181231 71379-060_1b9507ad-1f1a-4754-9654-7a553d1743a4 71379-060 HUMAN OTC DRUG LAPCOS Stay With Me Cushion 02 Neutral Beige Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part352 LAP CO.,LTD TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.52; .8; .48 g/12g; g/12g; g/12g N 20181231 71380-0001_4cf2b530-73aa-7471-e054-00144ff8d46c 71380-0001 HUMAN OTC DRUG Brucke Keep Cooling Foilgel Lifting Mask Adenosine LIQUID TOPICAL 20170412 UNAPPROVED DRUG OTHER Nature4 co., Ltd. ADENOSINE .04 g/100g N 20181231 71380-0002_4d071937-8fca-3110-e054-00144ff88e88 71380-0002 HUMAN OTC DRUG Brucke Keep Cooling Hydrogel Soothing Mask Niacinamide, Adenosine LIQUID TOPICAL 20170412 UNAPPROVED DRUG OTHER Nature4 co., Ltd. ADENOSINE; NIACINAMIDE .04; 2 g/100g; g/100g N 20181231 71380-0003_4f996dff-cf07-4bd0-e054-00144ff8d46c 71380-0003 HUMAN OTC DRUG Brucke A.C.C. Calming Mist GLYCERIN LIQUID TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part347 Nature4 co., Ltd. GLYCERIN 2 g/100mL N 20181231 71380-0004_4f9a9d09-10f5-1c74-e054-00144ff88e88 71380-0004 HUMAN OTC DRUG Brucke A.C.C. Cure Ampoule Adenosine, Niacinamide GEL TOPICAL 20170515 UNAPPROVED DRUG OTHER Nature4 co., Ltd. ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71380-0005_4fb313bd-b6be-6065-e054-00144ff88e88 71380-0005 HUMAN OTC DRUG INTEGRAL B Keep Calming Mist GLYCERIN LIQUID TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part347 Nature4 co., Ltd. GLYCERIN 2 g/100mL N 20181231 71380-0006_55330d7b-bd0d-5ca5-e054-00144ff8d46c 71380-0006 HUMAN OTC DRUG A.C.C Fresh and Cooling Scalp Mist Menthol LIQUID TOPICAL 20170726 UNAPPROVED DRUG OTHER Nature4 co., Ltd. MENTHOL .3 g/100mL N 20181231 71383-014_577a6fed-7e6a-47c6-af44-bcfbc4675126 71383-014 HUMAN OTC DRUG Deeveeant Numb Lidocaine CREAM TOPICAL 20170430 OTC MONOGRAPH FINAL part348 Valekista Limited LIDOCAINE 40 mg/g N 20181231 71383-024_906c3414-a2c8-4038-9d38-0fd0fbbfdf94 71383-024 HUMAN OTC DRUG MediNumb Lidocaine CREAM TOPICAL 20170430 OTC MONOGRAPH FINAL part348 Valekista Limited LIDOCAINE 40 mg/g N 20181231 71384-502_6389e970-c7dd-958e-e053-2a91aa0acb11 71384-502 HUMAN PRESCRIPTION DRUG Pred-Gati Prednisolone Acetate-Gatifloxacin SUSPENSION/ DROPS OPHTHALMIC 20180105 UNAPPROVED DRUG OTHER Imprimis NJOF, LLC GATIFLOXACIN; PREDNISOLONE ACETATE 5; 10 mg/mL; mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 71384-503_638a351f-2b10-fd17-e053-2991aa0ae9a5 71384-503 HUMAN PRESCRIPTION DRUG Pred-Gati-Brom Prednisolone Acetate-Gatifloxacin-Bromfenac SUSPENSION/ DROPS OPHTHALMIC 20180112 UNAPPROVED DRUG OTHER Imprimis NJOF, LLC BROMFENAC SODIUM; PREDNISOLONE ACETATE; GATIFLOXACIN .75; 10; 5 mg/mL; mg/mL; mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 71384-504_638a1f49-53eb-7a69-e053-2991aa0a82bc 71384-504 HUMAN PRESCRIPTION DRUG Pred-Gati-Brom Prednisolone Acetate-Gatifloxacin-Bromfenac SUSPENSION/ DROPS OPHTHALMIC 20180105 UNAPPROVED DRUG OTHER Imprims NJOF, LLC BROMFENAC; GATIFLOXACIN; PREDNISOLONE ACETATE .75; 5; 10 mg/mL; mg/mL; mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 71384-505_632b3f47-ae7c-3e64-e053-2991aa0a59f9 71384-505 HUMAN PRESCRIPTION DRUG Pred-Brom Prednisolone Acetate-Bromfenac SUSPENSION/ DROPS OPHTHALMIC 20180105 UNAPPROVED DRUG OTHER Imprimis NJOF, LLC PREDNISOLONE ACETATE; BROMFENAC SODIUM 10; .75 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71384-506_638a1f49-53e8-7a69-e053-2991aa0a82bc 71384-506 HUMAN PRESCRIPTION DRUG Gati-Dex Gatifloxacin-Dexamethasone Phosphate SOLUTION/ DROPS OPHTHALMIC 20180105 UNAPPROVED DRUG OTHER Imprimis NJOF, LLC DEXAMETHASONE SODIUM PHOSPHATE; GATIFLOXACIN 1; 5 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 71384-510_638a4320-9c17-4122-e053-2991aa0af758 71384-510 HUMAN PRESCRIPTION DRUG Triamcinolone-Moxifloxacin PF Triamcinolone-Moxifloxacin PF INJECTION, SUSPENSION OPHTHALMIC 20180105 UNAPPROVED DRUG OTHER Imprimis NJOF, LLC TRIAMCINOLONE ACETONIDE; MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 15; 1 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 71384-511_638f29bd-4f5a-d09a-e053-2a91aa0a017b 71384-511 HUMAN PRESCRIPTION DRUG Moxifloxacin PF Moxifloxacin PF INJECTION, SOLUTION OPHTHALMIC 20180105 UNAPPROVED DRUG OTHER Imprimis NJOF, LLC MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 5 mg/mL Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 71384-512_638a4320-9c27-4122-e053-2991aa0af758 71384-512 HUMAN PRESCRIPTION DRUG Dex-Moxi Dexamethasone Phosphate - Moxifloxacin INJECTION, SOLUTION OPHTHALMIC 20180105 UNAPPROVED DRUG OTHER Imprimis NJOF, LLC DEXAMETHASONE SODIUM PHOSPHATE; MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 1; 5 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] N 20191231 71384-513_638a4320-9c22-4122-e053-2991aa0af758 71384-513 HUMAN PRESCRIPTION DRUG Dex-Moxi-Ketor Dexamethasone Phosphate - Moxifloxacin - Ketorolac Tromethamine INJECTION, SOLUTION OPHTHALMIC 20180105 UNAPPROVED DRUG OTHER Imprimis NJOF, LLC DEXAMETHASONE SODIUM PHOSPHATE; MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE; KETOROLAC TROMETHAMINE 1; .5; .4 mg/mL; mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20191231 71387-820_4cfb6824-6320-1f9d-e054-00144ff8d46c 71387-820 HUMAN OTC DRUG Direct Naturals Fungus Clear UNDECYLENIC ACID LIQUID TOPICAL 20170412 OTC MONOGRAPH FINAL part333C Active Health Solutions UNDECYLENIC ACID 100 mg/mL N 20181231 71388-001_4d257210-2039-3283-e054-00144ff88e88 71388-001 HUMAN OTC DRUG BB Care Ultra Light Sunscreen Broad Spectrum SPF 50 Plus TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170414 OTC MONOGRAPH NOT FINAL part352 Beauty Be Co., Ltd TITANIUM DIOXIDE; ZINC OXIDE 78.2; 9.6 mg/g; mg/g N 20181231 71389-001_5393c5bd-e575-63c1-e054-00144ff8d46c 71389-001 HUMAN OTC DRUG CHLORA-CLEANZE chlorhexidine gluconate and isopropyl alcohol SWAB TOPICAL 20170418 OTC MONOGRAPH NOT FINAL part333A Biotronix Healthcare Industries, Inc. ISOPROPYL ALCOHOL; CHLORHEXIDINE GLUCONATE .7; 20 mL/mL; mg/mL N 20181231 71389-001_5446e6c8-bbc0-5475-e054-00144ff8d46c 71389-001 HUMAN OTC DRUG CHLORA-CLEANZE chlorhexidine gluconate and isopropyl alcohol SWAB TOPICAL 20170418 OTC MONOGRAPH NOT FINAL part333A Biotronix Healthcare Industries, Inc. ISOPROPYL ALCOHOL; CHLORHEXIDINE GLUCONATE .7; 20 mL/mL; mg/mL N 20181231 71389-001_54484bc3-ec17-4ae0-e054-00144ff88e88 71389-001 HUMAN OTC DRUG CHLORA-CLEANZE chlorhexidine gluconate and isopropyl alcohol SWAB TOPICAL 20170418 OTC MONOGRAPH NOT FINAL part333A Biotronix Healthcare Industries, Inc. CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 20; .7 mg/mL; mL/mL N 20181231 71389-001_54488be4-6181-5795-e054-00144ff88e88 71389-001 HUMAN OTC DRUG CHLORA-CLEANZE chlorhexidine gluconate and isopropyl alcohol SWAB TOPICAL 20170418 OTC MONOGRAPH NOT FINAL part333A Biotronix Healthcare Industries, Inc. ISOPROPYL ALCOHOL; CHLORHEXIDINE GLUCONATE .7; 20 mL/mL; mg/mL N 20181231 71392-010_2ed30af5-2c25-437c-9d76-742bf1df5a06 71392-010 HUMAN OTC DRUG FRESH MANDARIN AROMATHERAPY MASK Niacinamide PATCH TOPICAL 20170401 UNAPPROVED DRUG OTHER AROMA YONG NIACINAMIDE .44 g/22g N 20181231 71392-020_8c346a35-1963-45ba-97f9-f9b9d28e868d 71392-020 HUMAN OTC DRUG COOL MINT AROMATHERAPY MASK Glycerin PATCH TOPICAL 20170401 UNAPPROVED DRUG OTHER AROMA YONG GLYCERIN .22 g/22g N 20181231 71392-040_67ab60f2-6d28-45c5-91c7-f8a4fe1b41e6 71392-040 HUMAN OTC DRUG LOVELY GERANIUM AROMATHERAPY MASK Adenosine PATCH TOPICAL 20170501 UNAPPROVED DRUG OTHER AROMA YONG ADENOSINE .01 g/25g N 20181231 71393-001_4ce57287-184b-4b5b-e054-00144ff8d46c 71393-001 HUMAN OTC DRUG Skinprint ClearTone with 2% Hydroquinone Skinprint ClearTone with 2% Hydroquinone LIQUID TOPICAL 20131202 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. HYDROQUINONE .02 g/g N 20181231 71393-002_4f30259e-691c-0eed-e054-00144ff8d46c 71393-002 HUMAN PRESCRIPTION DRUG Skinprint ClearTone with 8% Hydroquinone Skinprint ClearTone with 8% Hydroquinone LIQUID TOPICAL 20131209 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. HYDROQUINONE .08 g/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 71393-003_4fd2fd45-e593-291a-e054-00144ff88e88 71393-003 HUMAN OTC DRUG Skinprint Recover Lightening Complex with 2% Hydroquinone Skinprint Recover Lightening Complex Complex with 2% Hydroquinone LOTION TOPICAL 20110216 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. HYDROQUINONE .02 g/g N 20181231 71393-004_5048b657-38e7-22f7-e054-00144ff8d46c 71393-004 HUMAN PRESCRIPTION DRUG Recover Lightening Complex with 4% Hydroquinone Recover Lightening Complex with 4% Hydroquinone LOTION TOPICAL 20110216 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. HYDROQUINONE .04 g/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 71393-005_51c7d6d4-3652-0a53-e054-00144ff88e88 71393-005 HUMAN OTC DRUG LumaSilk Emulsion Level 02 LumaSilk Emulsion Level 02 EMULSION TOPICAL 20170701 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. HYDROQUINONE .02 g/g N 20181231 71393-006_51ca5b57-f48c-716d-e054-00144ff8d46c 71393-006 HUMAN PRESCRIPTION DRUG LumaSilk Emulsion Level 03 LumaSilk Emulsion Level 03 EMULSION TOPICAL 20170701 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. HYDROQUINONE .04 g/g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 71393-007_5f1262c9-cbcb-9b31-e053-2a91aa0af7dc 71393-007 HUMAN OTC DRUG Skinprint Blemish Control Cleanser Skinprint Blemish Control Cleanserr LIQUID TOPICAL 20150508 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. SALICYLIC ACID .2 g/g N 20181231 71393-008_5f12690b-9e20-0108-e053-2991aa0a16ca 71393-008 HUMAN OTC DRUG Skinprint Blemish Control Toner Skinprint Blemish Control Toner LIQUID TOPICAL 20061108 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. SALICYLIC ACID .2 g/g N 20181231 71393-009_59b8db2c-dbc5-d6d7-e053-2991aa0a07dd 71393-009 HUMAN OTC DRUG Skinprint Acne Release Skinprint Acne Release LOTION TOPICAL 20090806 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. BENZOYL PEROXIDE 2.5 g/100g N 20181231 71393-010_5cedc020-4f9a-5f08-e053-2991aa0a1659 71393-010 HUMAN OTC DRUG Skinprint Spot-On Skinprint Spot-On LOTION TOPICAL 20121008 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. BENZOYL PEROXIDE 5 g/100g N 20181231 71393-011_5cf2536d-33fe-6d0e-e053-2991aa0ae486 71393-011 HUMAN OTC DRUG Skinprint Ultra Sheer SPF 20 Skinprint Ultra Sheer SPF 20 LOTION TOPICAL 20090806 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. OCTINOXATE; AVOBENZONE; OCTOCRYLENE; ENSULIZOLE 6; 1.5; 1.2; 3 g/100g; g/100g; g/100g; g/100g N 20181231 71393-012_5f0df3d2-dc93-1113-e053-2991aa0a2b7d 71393-012 HUMAN OTC DRUG Skinprint Ultra Sheer SPF 20 Skinprint Ultra Sheer SPF 20 LOTION TOPICAL 20101006 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. HOMOSALATE; OXYBENZONE; OCTISALATE; ENSULIZOLE; OCTOCRYLENE; AVOBENZONE 15; 5; 5; 4; 2.7; 3 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 71393-013_5f10cc6b-8bc0-0b20-e053-2991aa0ac19d 71393-013 HUMAN PRESCRIPTION DRUG Sebaceous Hyperplasia Treatment Sebaceous Hyperplasia Treatment GEL TOPICAL 20130327 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. SALICYLIC ACID 8 g/100g N 20181231 71393-014_5f3a4946-9205-3ccf-e053-2a91aa0a1b39 71393-014 HUMAN PRESCRIPTION DRUG Skinprint 3D Bio Peel Skinprint 3D Bio Peel LIQUID TOPICAL 20130221 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. SALICYLIC ACID 4 g/100g N 20181231 71393-015_6025cb71-f0ea-04cb-e053-2a91aa0a8948 71393-015 HUMAN PRESCRIPTION DRUG Skinprint 3D Clear Peel Skinprint 3D Clear Peel LIQUID TOPICAL 20130516 UNAPPROVED DRUG OTHER The Skin Atelier, Inc. HYDROQUINONE 8 g/100g Depigmenting Activity [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA] N 20181231 71394-415_512ef6fb-1997-4fcb-b817-9b0a8c47147a 71394-415 HUMAN PRESCRIPTION DRUG LUXTURNA voretigene neparvovec-rzyl KIT 20171219 BLA BLA125610 Spark Therapeutics, Inc. N 20191231 71397-821_4dec259d-1ff9-44f2-e054-00144ff8d46c 71397-821 HUMAN OTC DRUG ACNE SPOT REPAIR BENZOYL PEROXIDE LOTION TOPICAL 20170420 OTC MONOGRAPH FINAL part333D menScience Androceuticals, LLC BENZOYL PEROXIDE 100 mg/g N 20181231 71397-822_4dec259d-200f-44f2-e054-00144ff8d46c 71397-822 HUMAN OTC DRUG ACNE THERAPY BENZOYL PEROXIDE LOTION TOPICAL 20170420 OTC MONOGRAPH FINAL part333D menScience Androceuticals, LLC BENZOYL PEROXIDE 30 mg/g N 20181231 71398-001_ddd7e3c9-9948-48a8-a4d3-f45004e308cb 71398-001 HUMAN OTC DRUG Pollution Shield SPF 46 Broad Spectrum Sunscreen Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20170615 OTC MONOGRAPH FINAL part352 SENTÉ, Inc. TITANIUM DIOXIDE; ZINC OXIDE 53; 145 mg/g; mg/g N 20181231 71399-0500_d8c170fe-835b-4bf3-af40-f9e25847bb07 71399-0500 HUMAN OTC DRUG Clotrimazole Clotrimazole SOLUTION TOPICAL 20170515 OTC MONOGRAPH FINAL part333C Akron Pharma Inc CLOTRIMAZOLE 1 g/mL N 20181231 71399-0510_716757b1-bc2b-419e-bda8-e79bc1710473 71399-0510 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170519 ANDA ANDA205519 Akron Pharma Inc ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 71399-0520_716757b1-bc2b-419e-bda8-e79bc1710473 71399-0520 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170519 ANDA ANDA205519 Akron Pharma Inc ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 71399-0540_716757b1-bc2b-419e-bda8-e79bc1710473 71399-0540 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170519 ANDA ANDA205519 Akron Pharma Inc ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 71399-0551_cdcbb173-74f8-4a0d-87f9-5383cc4f9af0 71399-0551 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170511 ANDA ANDA204989 Akron Pharma Inc GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71399-0553_cdcbb173-74f8-4a0d-87f9-5383cc4f9af0 71399-0553 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170511 ANDA ANDA204989 Akron Pharma Inc GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71399-0554_cdcbb173-74f8-4a0d-87f9-5383cc4f9af0 71399-0554 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20170511 ANDA ANDA204989 Akron Pharma Inc GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71399-0556_778f8787-08d2-457a-844a-d13c867cfad1 71399-0556 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20170512 ANDA ANDA205101 Akron Pharma Inc GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71399-0558_778f8787-08d2-457a-844a-d13c867cfad1 71399-0558 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET ORAL 20170512 ANDA ANDA205101 Akron Pharma Inc GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71399-2420_5295c2f0-e108-4ab4-be86-7947c1a6958c 71399-2420 HUMAN PRESCRIPTION DRUG omeprazole sodium bicarbonate omeprazole sodium bicarbonate CAPSULE ORAL 20170512 ANDA ANDA207476 Akron Pharma Inc OMEPRAZOLE; SODIUM BICARBONATE 20; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 71399-2440_5295c2f0-e108-4ab4-be86-7947c1a6958c 71399-2440 HUMAN PRESCRIPTION DRUG omeprazole sodium bicarbonate omeprazole sodium bicarbonate CAPSULE ORAL 20170512 ANDA ANDA207476 Akron Pharma Inc OMEPRAZOLE; SODIUM BICARBONATE 40; 1100 mg/1; mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 71401-0007_1442bcf2-3fd6-4e8b-ad9e-4773449fca39 71401-0007 HUMAN OTC DRUG 2080 K Original Sodium Fluoride PASTE DENTAL 20170102 OTC MONOGRAPH FINAL part355 AK AMERICA SODIUM FLUORIDE .12 g/120g N 20181231 71403-020_d8cc65db-860d-46c4-97bb-6b218fa7f69d 71403-020 HUMAN PRESCRIPTION DRUG Umecta Mousse Urea Urea Foam AEROSOL, FOAM TOPICAL 20070901 UNAPPROVED DRUG OTHER EPI Health, Inc UREA 400 mg/g N 20181231 71403-049_e75725b7-5d70-4196-8c40-57081fc631b0 71403-049 HUMAN PRESCRIPTION DRUG Sitavig Acyclovir TABLET, DELAYED RELEASE BUCCAL 20140320 NDA NDA203791 EPI Health, Inc ACYCLOVIR 50 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 71405-823_4e76fd19-8f00-683a-e054-00144ff8d46c 71405-823 HUMAN OTC DRUG FUNGWAY Fungus Clearing UNDECYLENIC ACID LIQUID TOPICAL 20170429 OTC MONOGRAPH FINAL part333C Rs Ads, LLC UNDECYLENIC ACID 100 mg/mL N 20181231 71407-001_bbd76a91-039f-41f3-98f8-e7467af6cefe 71407-001 HUMAN OTC DRUG gesgep ONE DROP PERFECTION LIGHT Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20170503 OTC MONOGRAPH NOT FINAL part352 Daesik and Taeyoon Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 6.438; 2.1; .9; .873 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 71407-002_222fad19-130b-4dab-be7a-030864b2a0a2 71407-002 HUMAN OTC DRUG gesgep ONE DROP PERFECTION TRUE Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part352 Daesik and Taeyoon Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 6.438; 2.1; .9; .873 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 71407-003_5f0338a3-1f1a-4f3c-9b04-4526ca27bd82 71407-003 HUMAN OTC DRUG gesgep ONE DROP PERFECTION HEALTHY Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part352 Daesik and Taeyoon Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 6.438; 2.1; .9; .873 mg/30mL; mg/30mL; mg/30mL; mg/30mL N 20181231 71409-303_620dcdca-94e1-2bb0-e053-2991aa0a54f2 71409-303 HUMAN OTC DRUG COLD and FLU RELIEF COLD and FLU RELIEF PELLET ORAL; SUBLINGUAL 20170714 UNAPPROVED HOMEOPATHIC Clineva Management Services, LLC ALLIUM CEPA WHOLE; ACONITUM NAPELLUS; ARNICA MONTANA; SOLANUM DULCAMARA WHOLE; ATROPA BELLADONNA; GELSEMIUM SEMPERVIRENS ROOT; EUPATORIUM CANNABINUM WHOLE 8; 14; 8; 8; 8; 18; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20191231 71409-311_620e0d1d-b067-2a86-e053-2a91aa0a9bef 71409-311 HUMAN OTC DRUG Sore Throat Relief Sore Throat Relief PELLET ORAL; SUBLINGUAL 20170718 UNAPPROVED HOMEOPATHIC Clineva Urgent Care APIS MELLIFERA; ATROPA BELLADONNA; ACONITUM NAPELLUS; PHYTOLACCA AMERICANA ROOT; MERCURIUS SOLUBILIS; SOLANUM DULCAMARA WHOLE 10; 10; 10; 8; 10; 8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20191231 71412-110_4e3fe418-d1da-3024-e054-00144ff88e88 71412-110 HUMAN OTC DRUG Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20170526 OTC MONOGRAPH FINAL part344 Ramon Canela Inc ISOPROPYL ALCOHOL .7 mL/1 N 20181231 71413-200_5b3733ad-8f1d-966f-e053-2991aa0a7970 71413-200 HUMAN OTC DRUG The Healthy Foundation SPF 20 Octinoxate CREAM TOPICAL 20171010 OTC MONOGRAPH NOT FINAL part352 Baja Fur, S.A. de C.V. OCTINOXATE 3 g/100mL N 20181231 71414-115_531e585f-55e3-6f37-e054-00144ff88e88 71414-115 HUMAN PRESCRIPTION DRUG ASCORBIC ACID ASCORBIC ACID INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20170401 UNAPPROVED DRUG OTHER FLON LABORATORIES LLC ASCORBIC ACID 500 mg/mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20181231 71414-225_5a586436-6def-46bf-e053-2991aa0a89a0 71414-225 HUMAN PRESCRIPTION DRUG VITAMIN B COMPLEX VITAMIN B COMPLEX INJECTION INTRAMUSCULAR; INTRAVENOUS 20170401 UNAPPROVED DRUG OTHER FLON LABORATORIES LLC THIAMINE HYDROCHLORIDE; DEXPANTHENOL; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM 100; 2; 100; 2; 2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 71414-301_5b34494b-7341-7bd4-e053-2a91aa0ad4cf 71414-301 HUMAN PRESCRIPTION DRUG DEHYDRATED ALCOHOL DEHYDRATED ALCOHOL INJECTION INTRASPINAL 20170401 UNAPPROVED DRUG OTHER FLON LABORATORIES LLC ALCOHOL .98 mL/mL N 20181231 71414-305_5a448eff-ac0a-2b36-e053-2a91aa0ac4fc 71414-305 HUMAN PRESCRIPTION DRUG DEHYDRATED ALCOHOL DEHYDRATED ALCOHOL INJECTION INTRASPINAL 20170401 UNAPPROVED DRUG OTHER FLON LABORATORIES LLC ALCOHOL .98 mL/mL N 20181231 71415-001_516166b4-2b31-140d-e054-00144ff8d46c 71415-001 HUMAN OTC DRUG Reme-D Arnica Arnica montana TABLET, CHEWABLE ORAL; SUBLINGUAL 20170601 UNAPPROVED HOMEOPATHIC Ilume Technologies, LLC ARNICA MONTANA FLOWER 30 [hp_C]/1 N 20181231 71416-001_60e2fd68-905b-db6a-e053-2a91aa0acb70 71416-001 HUMAN OTC DRUG Protocoxil BENZYL ALCOHOL GEL TOPICAL 20170509 OTC MONOGRAPH NOT FINAL part348 Bio Ekuiliber LLC BENZYL ALCOHOL 100 mg/g N 20181231 71416-002_60e2f712-4a7a-33bb-e053-2991aa0a1bec 71416-002 HUMAN OTC DRUG Protocoxil BENZYL ALCOHOL GEL TOPICAL 20170509 OTC MONOGRAPH NOT FINAL part348 Bio Ekuiliber LLC BENZYL ALCOHOL 100 mg/g N 20181231 71419-001_55a43d3c-ffc2-4d57-8bfc-5d8c45ccdd4f 71419-001 HUMAN OTC DRUG Magic For Pain Relief Camphor, Methyl Salicylate, Menthol SPRAY TOPICAL 20111201 OTC MONOGRAPH NOT FINAL part348 Zhuhai Aofute Medical Technology Co, Ltd CAMPHOR (SYNTHETIC); METHYL SALICYLATE; MENTHOL 10; 30; 16 g/100mL; g/100mL; g/100mL N 20181231 71421-101_bc76ec30-9fa4-4ebb-9a4c-19bc47de728e 71421-101 HUMAN OTC DRUG O SKIN ACNE MODERATE BENZOYL PEROXIDE CREAM TOPICAL 20170501 OTC MONOGRAPH FINAL part333D O SKIN CARE LLC BENZOYL PEROXIDE 5 g/100mL N 20181231 71421-102_7bf480f1-cd3d-4ec7-8825-06d3ec045ccf 71421-102 HUMAN OTC DRUG O SKIN ACNE BENZOYL WASH BENZOYL PEROXIDE LOTION TOPICAL 20170501 OTC MONOGRAPH FINAL part333D O SKIN CARE LLC BENZOYL PEROXIDE 2.5 g/100mL N 20181231 71423-825_4f2ed5d4-d9d5-405d-e054-00144ff8d46c 71423-825 HUMAN OTC DRUG Instant Therapy CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM CREAM TOPICAL 20170509 OTC MONOGRAPH NOT FINAL part348 Hampshire Laboratories Inc CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM 31; 13 mg/mL; mg/mL N 20181231 71424-1001_60560818-fd78-aaad-e053-2991aa0ac710 71424-1001 HUMAN OTC DRUG Shelo NABEL Crema Baba de Caracol Allantoin CREAM TOPICAL 20170519 OTC MONOGRAPH FINAL part347 Corporativo Serysi S de R L de C V ALLANTOIN 10 mg/g N 20181231 71424-1050_6055b48d-abcd-7023-e053-2a91aa0a5d6b 71424-1050 HUMAN OTC DRUG Shelo NABEL Anti Caspa Pyrithione Zinc SHAMPOO TOPICAL 20170518 OTC MONOGRAPH FINAL part358H Corporativo Serysi S de R L de C V PYRITHIONE ZINC 10 mg/g N 20181231 71424-1058_60299bd3-f31a-6dbd-e053-2991aa0af8c7 71424-1058 HUMAN OTC DRUG Shelo NABEL Arnica Gel Menthol GEL TOPICAL 20170518 OTC MONOGRAPH NOT FINAL part348 Corporativo Serysi S de R L de C V MENTHOL 12.5 mg/g N 20181231 71424-1059_602927da-382b-1ec5-e053-2991aa0a3d17 71424-1059 HUMAN OTC DRUG Shelo NABEL Pomada Arnica Menthol GEL TOPICAL 20170518 OTC MONOGRAPH NOT FINAL part348 Corporativo Serysi S de R L de C V MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC) 20; 30 mg/g; mg/g N 20181231 71424-1060_6029afb4-9a05-6f1c-e053-2991aa0a21a9 71424-1060 HUMAN OTC DRUG Shelo NABEL Hielo Mineral Menthol SPRAY TOPICAL 20170518 OTC MONOGRAPH NOT FINAL part348 Corporativo Serysi S de R L de C V CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM 2; 12.5 mg/g; mg/g N 20181231 71424-1061_6028bda6-6260-3597-e053-2991aa0aa09f 71424-1061 HUMAN OTC DRUG Shelo NABEL TherapyGel Menthol GEL TOPICAL 20170518 OTC MONOGRAPH NOT FINAL part348 Corporativo Serysi S de R L de C V MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC) 26; 20 mg/g; mg/g N 20181231 71424-1070_6055c0b6-a49f-de39-e053-2991aa0a19f4 71424-1070 HUMAN OTC DRUG Shelo NABEL Vibora de Cascabel Topical Analgesic Gel 250 ml menthol GEL TOPICAL 20170518 OTC MONOGRAPH NOT FINAL part348 Corporativo Serysi S de R L de C V MENTHOL, UNSPECIFIED FORM 2.6 mg/100g N 20181231 71424-1145_6055d474-e608-4fa3-e053-2991aa0a2cc7 71424-1145 HUMAN OTC DRUG Shelo NABEL D B T Cream Allantoin CREAM TOPICAL 20170518 OTC MONOGRAPH FINAL part347 Corporativo Serysi S de R L de C V ALLANTOIN 5 mg/g N 20181231 71424-1146_6055f828-c650-2e68-e053-2a91aa0a665d 71424-1146 HUMAN OTC DRUG Shelo NABEL CACAO Skin Protectan Allantoin CREAM TOPICAL 20170518 OTC MONOGRAPH FINAL part347 Corporativo Serysi S de R L de C V ALLANTOIN 5 mg/g N 20181231 71424-1156_6055b48d-abdc-7023-e053-2a91aa0a5d6b 71424-1156 HUMAN OTC DRUG Shelo NABEL Baba de Caracol Locion Corporal Allantoin CREAM TOPICAL 20170519 OTC MONOGRAPH FINAL part347 Corporativo Serysi S de R L de C V ALLANTOIN 10 mg/g N 20181231 71424-1161_5037bdfc-a3b0-533a-e054-00144ff88e88 71424-1161 HUMAN OTC DRUG Shelo NABEL Jabon Baba Car Allantoin SOAP CUTANEOUS 20170518 OTC MONOGRAPH FINAL part347 Corporativo Serysi S de R L de C V ALLANTOIN 5 mg/g N 20181231 71424-1222_6029ca11-a9b3-6f26-e053-2991aa0a9c9f 71424-1222 HUMAN OTC DRUG Shelo NABEL Baba de Caracol Allantoin CREAM TOPICAL 20170519 OTC MONOGRAPH FINAL part347 Corporativo Serysi S de R L de C V ALLANTOIN 5 mg/g N 20181231 71424-1347_60293d19-31b0-a852-e053-2a91aa0aade8 71424-1347 HUMAN OTC DRUG Shelo NABEL Gel para Golpes Menthol GEL TOPICAL 20170518 OTC MONOGRAPH NOT FINAL part348 Corporativo Serysi S de R L de C V MENTHOL, UNSPECIFIED FORM 12.6 mg/g N 20181231 71424-7713_5aac259f-a51c-4f2e-e053-2991aa0af709 71424-7713 HUMAN OTC DRUG Jabon Shelo Nabel Con Alantoina Baba de Caracol Allantoin SOAP CUTANEOUS; TOPICAL 20171002 OTC MONOGRAPH FINAL part347 Corporativo Serysi S de R L de C V ALLANTOIN 5 mg/g N 20181231 71425-010_4f18356d-a83b-2fa9-e054-00144ff88e88 71425-010 HUMAN OTC DRUG Glossier Invisible Shield Daily Sunscreen Broad Spectrum SPF 35 Glossier Invisible Shield Daily Sunscreen Broad Spectrum SPF 35 LOTION TOPICAL 20170509 OTC MONOGRAPH FINAL part352 Glossier Inc. AVOBENZONE; HOMOSALATE; OCTISALATE 3; 6; 5 g/100g; g/100g; g/100g N 20181231 71425-020_5cd93804-fd4c-5f8b-e053-2991aa0a7989 71425-020 HUMAN OTC DRUG Glossier solution exfoliating skin perfector Glossier solution exfoliating skin perfector LIQUID TOPICAL 20171130 OTC MONOGRAPH FINAL part333D Glossier Inc. SALICYLIC ACID .5 g/100g N 20181231 71427-213_4f18b7b6-ff38-2cf3-e054-00144ff8d46c 71427-213 HUMAN OTC DRUG Kong HandiPOD ALCOHOL GEL TOPICAL 20170509 OTC MONOGRAPH NOT FINAL part333E HANDIPOD LIMITED ALCOHOL 700 mg/mL N 20181231 71430-100_390b8201-5ee9-4b96-9464-3fae4bbb9c79 71430-100 HUMAN OTC DRUG HemRid MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOE witch hazel cloth SWAB TOPICAL 20170501 OTC MONOGRAPH FINAL part346 BELLIGADRIA SOLLUTIONS LLC WITCH HAZEL .5 g/g N 20181231 71433-123_60c70d70-a9f2-7644-e053-2a91aa0a7cf6 71433-123 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20170509 UNAPPROVED MEDICAL GAS Oxygen Rich, LLC OXYGEN 99 L/100L N 20181231 71435-8202_033c8c6a-18e8-4197-a2b0-61339bd0bddc 71435-8202 HUMAN OTC DRUG Milani Prime Protect SPF 30 Face Primer Avobenzone, Octinoxate, Octocrylene, and Oxybenzone CREAM TOPICAL 20171125 OTC MONOGRAPH NOT FINAL part352 The Milani Group, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 30; 73; 30; 20 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71436-0024_0dbc1594-d0ff-4e73-b1bb-81b49221f892 71436-0024 HUMAN OTC DRUG FOOT HANGOVER Lidocaine HCL LIQUID TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part348 Ari Brands, Llc LIDOCAINE HYDROCHLORIDE 4 g/100mL N 20191231 71437-425_415ef797-04c0-444e-8b74-7fcc0e042f4b 71437-425 HUMAN PRESCRIPTION DRUG LidoPR diclofenac gel, METHYL SALICYLATE, MENTHOL cream KIT 20170201 ANDA ANDA208077 19 And Pacific, Llc N 20181231 71437-463_4566aa43-ea37-4d48-a82c-55a61f81df05 71437-463 HUMAN OTC DRUG Lidothal Relief Menthol, Lidocaine PATCH TOPICAL 20170731 OTC MONOGRAPH NOT FINAL part348 19 And Pacific, Llc MENTHOL; LIDOCAINE 1; 4 g/100g; g/100g N 20181231 71437-525_8a15b540-62c0-4024-8d47-084c59a69aa0 71437-525 HUMAN PRESCRIPTION DRUG DicloPR diclofenac gel, METHYL SALICYLATE, MENTHOL cream KIT 20170201 ANDA ANDA208077 19 And Pacific, Llc N 20181231 71438-010_5cd95af9-1cfc-2df8-e053-2a91aa0a8505 71438-010 HUMAN OTC DRUG Oribe Serene Scalp Anti Dandruff Oribe Serene Scalp Anti Dandruff LOTION TOPICAL 20171120 OTC MONOGRAPH FINAL part358H Oribe Hair Care LLC SALICYLIC ACID 2 g/100g N 20181231 71439-040_5876e61c-12d7-2313-e053-2a91aa0ab75a 71439-040 HUMAN OTC DRUG made of Diaper Rash Cream ZINC OXIDE CREAM TOPICAL 20170905 OTC MONOGRAPH NOT FINAL part352 MADEOF, LLC ZINC OXIDE 14 g/100mL N 20181231 71439-050_5877736b-2956-56ce-e053-2991aa0a456e 71439-050 HUMAN OTC DRUG made of Broad Spectrum SPF 30 Non-Nano Zinc Oxide Sunscreen ZINC OXIDE LOTION TOPICAL 20170905 OTC MONOGRAPH NOT FINAL part352 MADEOF, LLC ZINC OXIDE 20 g/100mL N 20181231 71441-180_4ad98338-8e8d-402c-b5de-b0a8dfba52b0 71441-180 HUMAN OTC DRUG ONID Wipe Ethanol SWAB TOPICAL 20170628 OTC MONOGRAPH NOT FINAL part333E ONID Technology Corp ALCOHOL 75 mL/100mL N 20181231 71443-001_987aa9cc-4f7e-442b-b901-a60597a5ad32 71443-001 HUMAN OTC DRUG QUALITY CHOICE SINGLE SALINE LAXATIVE SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM ENEMA RECTAL 20170705 OTC MONOGRAPH NOT FINAL part334 Alcyon Health, LLC. SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 7; 19 g/118mL; g/118mL N 20181231 71446-001_1ba7ad27-8e95-4081-8ca3-aaef576761bd 71446-001 HUMAN OTC DRUG Dr Tans Arthritis Formula 3 day Patch Menthol PATCH TOPICAL 20170523 OTC MONOGRAPH NOT FINAL part348 Great Loong LLC MENTHOL .5 g/g N 20181231 71446-002_a4befb14-835d-4494-8787-808560069edc 71446-002 HUMAN OTC DRUG Dr Tans Pain Releiving 3 day Herabl Patch PEPPERMINT PATCH TOPICAL 20170525 OTC MONOGRAPH NOT FINAL part356 Great Loong LLC PEPPERMINT OIL .3 g/g N 20181231 71447-002_51362275-b803-5d78-e054-00144ff8d46c 71447-002 HUMAN OTC DRUG NELLY DEVUYST ORGANIC SUNSCREEN NATURAL PROTECTION BROAD SPECTRUM SPF30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170612 OTC MONOGRAPH FINAL part352 LABORATOIRES DRUIDE INC TITANIUM DIOXIDE; ZINC OXIDE 65; 63 g/g; g/g N 20181231 71450-0001_50530ac7-0d33-1485-e054-00144ff8d46c 71450-0001 HUMAN OTC DRUG CELLBN DAMAGE OVERNIGHT RECOVERY Arbutin, Adenosine CREAM TOPICAL 20170526 UNAPPROVED DRUG OTHER WORLDCOSTEC.CO.,LTD ARBUTIN; ADENOSINE 2; .05 g/100mL; g/100mL N 20181231 71450-0002_509f8084-6e75-39c1-e054-00144ff88e88 71450-0002 HUMAN OTC DRUG CELLBN DAMAGE ANTI-AGING EYE REVIVER Arbutin, Adenosine CREAM TOPICAL 20170526 UNAPPROVED DRUG OTHER WORLDCOSTEC.CO.,LTD ARBUTIN; ADENOSINE 2; .05 g/100mL; g/100mL N 20181231 71450-0003_50a0340e-2af0-6776-e054-00144ff88e88 71450-0003 HUMAN OTC DRUG CELLBN DAMAGE DEEP MOISTURE Arbutin, Adenosine CREAM TOPICAL 20170526 UNAPPROVED DRUG OTHER WORLDCOSTEC.CO.,LTD ARBUTIN; ADENOSINE 2; .05 g/100mL; g/100mL N 20181231 71450-0004_50a0340e-2b06-6776-e054-00144ff88e88 71450-0004 HUMAN OTC DRUG CELLBN DAMAGE MULTI ACTION TONER Arbutin, Adenosine LIQUID TOPICAL 20170526 UNAPPROVED DRUG OTHER WORLDCOSTEC.CO.,LTD ARBUTIN; ADENOSINE 1; .05 g/100mL; g/100mL N 20181231 71450-0005_50a0340e-2b14-6776-e054-00144ff88e88 71450-0005 HUMAN OTC DRUG CELLBN DAMAGE PRECIOUS SERUM Arbutin, Adenosine GEL TOPICAL 20170526 UNAPPROVED DRUG OTHER WORLDCOSTEC.CO.,LTD ARBUTIN; ADENOSINE 1; .05 g/100mL; g/100mL N 20181231 71450-0006_50a3670a-008d-09c9-e054-00144ff8d46c 71450-0006 HUMAN OTC DRUG CELLBN FIRST CARE CLEANSER Stearic Acid CREAM TOPICAL 20170526 UNAPPROVED DRUG OTHER WORLDCOSTEC.CO.,LTD STEARIC ACID 16 g/100mL N 20181231 71450-0007_50a3670a-008f-09c9-e054-00144ff8d46c 71450-0007 HUMAN OTC DRUG CELLBN MEGA PLUS Menthol SHAMPOO TOPICAL 20170526 UNAPPROVED DRUG OTHER WORLDCOSTEC.CO.,LTD MENTHOL .3 g/100mL N 20181231 71450-0008_50cbcdb9-b3ae-64fc-e054-00144ff88e88 71450-0008 HUMAN OTC DRUG CELLBN SP HIGH MULTI SERUM Arbutin, Adenosine GEL TOPICAL 20170526 UNAPPROVED DRUG OTHER WORLDCOSTEC.CO.,LTD ARBUTIN; ADENOSINE 2; .05 g/100mL; g/100mL N 20181231 71450-0010_50a3e5c4-a9f8-3f9c-e054-00144ff8d46c 71450-0010 HUMAN OTC DRUG CELLXV REAL KELP FACIAL MASK Arbutin, Adenosine LIQUID TOPICAL 20170526 UNAPPROVED DRUG OTHER WORLDCOSTEC.CO.,LTD ADENOSINE; ARBUTIN .03; 1 g/100mL; g/100mL N 20181231 71450-0011_50c8ccf6-d7d8-64f6-e054-00144ff88e88 71450-0011 HUMAN OTC DRUG CELLBN SP LIFTING CONCENTRATEAMPOULE Arbutin, Adenosine GEL TOPICAL 20170526 UNAPPROVED DRUG OTHER WORLDCOSTEC.CO.,LTD ARBUTIN; ADENOSINE 2; .05 g/100mL; g/100mL N 20181231 71451-001_dc3d1fb9-2926-43fc-b39a-2248e8ce0451 71451-001 HUMAN OTC DRUG Pro-Enema Single Saline Laxative Sodium Phosphate, Dibasic and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM ENEMA RECTAL 20170606 OTC MONOGRAPH NOT FINAL part334 Propharma Medical Supplies SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 7; 19 g/118mL; g/118mL N 20181231 71453-211_e69b731a-d0fb-4c85-8902-94f49128807b 71453-211 HUMAN OTC DRUG Cool Comfort ORGANIC WITCH HAZEL SWAB TOPICAL 20171129 OTC MONOGRAPH FINAL part346 Naticura Inc WITCH HAZEL 60 g/100g N 20181231 71454-3645_543eed82-c93a-01c1-e054-00144ff88e88 71454-3645 HUMAN OTC DRUG BATURE UV PROTECT SUNSCREEN zinc oxide, titanium dioxide CREAM TOPICAL 20170815 20190922 OTC MONOGRAPH NOT FINAL part352 GC US CORPORATION ZINC OXIDE; TITANIUM DIOXIDE 5.56; 1.42 g/50g; g/50g N 20181231 71454-3646_5003dfaf-cf8c-0dd5-e054-00144ff88e88 71454-3646 HUMAN OTC DRUG MIUNORI NATURAL BABY SUNSCREEN zinc oxide, titanium dioxide CREAM TOPICAL 20170701 20190922 OTC MONOGRAPH NOT FINAL part352 GC US CORPORATION ZINC OXIDE; TITANIUM DIOXIDE 5.56; 1.42 g/50g; g/50g N 20181231 71456-001_be0d4e4e-00f7-4a0b-982b-459b56e3cef1 71456-001 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate sodium bicarbonate INJECTION, SOLUTION INTRAVENOUS 20170524 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Phebra Pty Ltd SODIUM BICARBONATE 84 mg/mL N 20181231 71461-0001_525c5c45-759a-58d4-e054-00144ff88e88 71461-0001 HUMAN OTC DRUG VOLVIAN GOLDEN SILKWORM WATER BOMB GLYCERIN CREAM TOPICAL 20170501 UNAPPROVED DRUG OTHER ph5 GLYCERIN 4 g/100g N 20181231 71464-0001_5324ea46-8f2c-5c97-e054-00144ff88e88 71464-0001 HUMAN OTC DRUG Limulus Deep Sea Moisture NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170501 UNAPPROVED DRUG OTHER Skin R&D ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71464-0002_53639a00-0bec-32b8-e054-00144ff88e88 71464-0002 HUMAN OTC DRUG Limulus Nourishing ADENOSINE CREAM TOPICAL 20170501 UNAPPROVED DRUG OTHER Skin R&D ADENOSINE .04 g/100mL N 20181231 71464-0003_5363efd1-6521-0682-e054-00144ff8d46c 71464-0003 HUMAN OTC DRUG Limulus The 1 and Only NIACINAMIDE, ADENOSINE LOTION TOPICAL 20170501 UNAPPROVED DRUG OTHER Skin R&D ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71464-0004_52fd13ae-b261-702f-e054-00144ff8d46c 71464-0004 HUMAN OTC DRUG Limulus Bio Cellulose Mask Glycerin, Niacinamide, Adenosine KIT 20170628 UNAPPROVED DRUG OTHER Skin R&D N 20181231 71466-001_5f0c36b0-bb6a-836a-e053-2991aa0ad40f 71466-001 HUMAN OTC DRUG Bambo Nature Sunny Day Titanium Dioxide CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part352 Abena North America, Inc. TITANIUM DIOXIDE 8.46 g/100g N 20181231 71471-269_610897df-2781-a1c7-e053-2991aa0ae350 71471-269 HUMAN OTC DRUG Aqua Plus Acne Treatment System SALICYLIC ACID KIT 20170901 OTC MONOGRAPH FINAL part333D Totally Clear Products, Inc N 20181231 71472-010_d507210f-35c5-4b26-aadf-4ca69e210ded 71472-010 HUMAN OTC DRUG SIERO TURNOVER 21 CREA M PACK Dimethicone CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE 2 g/50mL N 20181231 71472-020_cdd404cd-027f-4cae-977c-597b623383dc 71472-020 HUMAN OTC DRUG SIERO DU KIND CLEANSING SHERBET MINERAL OI L CREAM TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. MINERAL OIL 49.46 g/90mL N 20181231 71472-030_ef58d680-72cb-4b61-bef3-126d51bb3a1b 71472-030 HUMAN OTC DRUG SIERO CO AQUA CUSHION FOUNDATION 13 LIGHT BEIGE Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 JNG KOREA CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 71472-040_55f71b6a-b544-4a2e-ab59-598b86f78694 71472-040 HUMAN OTC DRUG SIERO CO AQUA CUSHION FOUNDATION 21 NATURAL BEIGE Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 JNG KOREA CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 71472-050_335b3953-c318-46e3-8eee-a2d3b6796e9a 71472-050 HUMAN OTC DRUG SIERO CO AQUA CUSHION FOUNDATION 23 ROSY BEIGE Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 JNG KOREA CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 71472-060_db5230b0-7eb6-48a0-960d-374afe149ac3 71472-060 HUMAN OTC DRUG SIERO DOUBLE CO AQUA CC CUSHION 13 LIGHT BEIGE Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 JNG KOREA CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 71472-070_ef0b7271-8f62-4910-ab8d-13ba736fd1b7 71472-070 HUMAN OTC DRUG SIERO DOUBLE CO AQUA CC CUSHION 21 NATURAL BEIGE Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 JNG KOREA CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 71472-080_c9ccb2b6-ceca-4b59-a62d-5a4b095f9bcb 71472-080 HUMAN OTC DRUG SIERO DOUBLE CO AQUA CC CUSHION 23 ROSY BEIGE Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 JNG KOREA CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 71472-090_58408233-9ea3-44aa-af0b-3d49e9fec173 71472-090 HUMAN OTC DRUG SIERO TYRIAN RED CUSHION 13 LIGHT BEIGE Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 JNG KOREA CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 71472-100_0e25eee6-8ea8-473d-b8e4-deae78e8e981 71472-100 HUMAN OTC DRUG SIERO TYRIAN RED CUSHION 21 NATURAL BEIGE Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 JNG KOREA CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 71472-110_15c4d5f2-307f-410c-8db7-c16b868ef032 71472-110 HUMAN OTC DRUG SIERO TYRIAN RED CUSHION 23 ROSY BEIGE Titanium Dioxide, Octinoxate, Octisalate, Octocrylene, Zinc Oxide POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 JNG KOREA CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE 1.35; 1.05; .72; .3; .3 g/15g; g/15g; g/15g; g/15g; g/15g N 20181231 71472-120_06f42bab-0b3e-42fe-972e-76ca35d6619f 71472-120 HUMAN OTC DRUG SIERO LABBRA SATIN PINK TASSEL DIMETHICONE GEL TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE 2.1 g/7.5mL N 20181231 71472-130_775e621b-aba9-4c55-800a-20c3824b044e 71472-130 HUMAN OTC DRUG SIERO LABBRA SATIN PINK PEONY DIMETHICONE GEL TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE 2.1 g/7.5mL N 20181231 71472-140_be259f46-4f94-4efb-b740-df26b24bb86b 71472-140 HUMAN OTC DRUG SIERO LABBRA SATIN MERMAID KISS DIMETHICONE GEL TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE 2.1 g/7.5mL N 20181231 71472-150_30d945e5-260b-4555-b256-23b69dbcb512 71472-150 HUMAN OTC DRUG SIERO LABBRA SATIN BRITISH ORANGE DIMETHICONE GEL TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE 2.1 g/7.5mL N 20181231 71472-160_f216e0e8-9f77-4a35-95ce-277abc242b19 71472-160 HUMAN OTC DRUG SIERO LABBRA SATIN MODERN LOVE DIMETHICONE GEL TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE 2.1 g/7.5mL N 20181231 71472-170_d1cb57dd-5fc0-4fbd-badd-233b745db5aa 71472-170 HUMAN OTC DRUG SIERO LABBRA SATIN RUSSIAN RED DIMETHICONE GEL TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE 2.1 g/7.5mL N 20181231 71472-180_49b4aaab-a29d-4f38-88a6-b0187237d1b2 71472-180 HUMAN OTC DRUG SIERO LABBRA SATIN CELOSIA RED DIMETHICONE GEL TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE 2.1 g/7.5mL N 20181231 71472-190_eb90b742-d3ea-434b-bcca-07f288671f3e 71472-190 HUMAN OTC DRUG SIERO LABBRA SATIN POPPY RED DIMETHICONE GEL TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE 2.1 g/7.5mL N 20181231 71472-200_80146f46-17cb-4217-b2b7-e9e2eca7fde0 71472-200 HUMAN OTC DRUG SIERO MO MORE ILLUMINATOR ROSY PINK TITANIUM DIOXIDE STICK TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 JNG KOREA CO.,LTD. TITANIUM DIOXIDE .6 g/9g N 20181231 71472-210_eab760c7-13f3-4153-b369-abc9f958a7c6 71472-210 HUMAN OTC DRUG SIERO MO MORE ILLUMINATOR SPARKLING GOLD TITANIUM DIOXIDE STICK TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 JNG KOREA CO.,LTD. TITANIUM DIOXIDE .55 g/9g N 20181231 71472-220_19d26afe-ff8f-44c4-9adc-b6ba4859d9e6 71472-220 HUMAN OTC DRUG SIERO CHEE CHEEK SUNNY ORANGE DIMETHICONE POWDER TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE .08 g/4.5g N 20181231 71472-230_f5390d02-53a7-47c0-9ca0-7da9384ab4b1 71472-230 HUMAN OTC DRUG SIERO CHEE CHEEK HUSHED PINK DIMETHICONE POWDER TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE .08 g/4.5g N 20181231 71472-240_9d4df999-cced-41dd-82a7-4eda9716ba10 71472-240 HUMAN OTC DRUG SIERO CHEE CHEEK CORAL DIMETHICONE POWDER TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE .07 g/4.5g N 20181231 71472-250_59623d62-672a-428a-a7a2-d236a7a03060 71472-250 HUMAN OTC DRUG SIERO CHEE CHEEK CLASSY PINK DIMETHICONE POWDER TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE .08 g/4.5g N 20181231 71472-260_7f79f095-e8df-453a-b845-f6bfde79a9aa 71472-260 HUMAN OTC DRUG SIERO VANISH OI L POWDE R PACT DIMETHICONE POWDER TOPICAL 20170601 OTC MONOGRAPH FINAL part347 JNG KOREA CO.,LTD. DIMETHICONE 1.05 g/10g N 20181231 71473-067_1132d567-9f15-4c1a-9013-194d872d7ca4 71473-067 HUMAN OTC DRUG Max-Relief with Boswellia and Aloe Vera Menthol, Unspecified Form and Camphor (Synthetic) GEL TOPICAL 20170530 OTC MONOGRAPH NOT FINAL part348 USConsultancy for Applied Research MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC) 7; 6 g/100g; g/100g N 20181231 71476-101_5510ee23-0789-3beb-e054-00144ff8d46c 71476-101 HUMAN OTC DRUG Dr Pausins Low Dose Chewable Aspirin Cherry Flavor Aspirin TABLET, CHEWABLE ORAL 20171010 OTC MONOGRAPH FINAL part343 Achlis Laboratories ASPIRIN 81 mg/1 N 20181231 71476-102_5510ee23-0789-3beb-e054-00144ff8d46c 71476-102 HUMAN OTC DRUG Dr Pausins Low Dose Chewable Aspirin Orange Flavor Aspirin TABLET, CHEWABLE ORAL 20171010 OTC MONOGRAPH FINAL part343 Achlis Laboratories ASPIRIN 81 mg/1 N 20181231 71476-103_5510ee23-0789-3beb-e054-00144ff8d46c 71476-103 HUMAN OTC DRUG Dr Pausins Low Dose Aspirin Aspirin TABLET, COATED ORAL 20171010 OTC MONOGRAPH FINAL part343 Achlis Laboratories ASPIRIN 81 mg/1 N 20181231 71476-104_5510ee23-0789-3beb-e054-00144ff8d46c 71476-104 HUMAN OTC DRUG Dr Pausins Aspirin Aspirin TABLET, COATED ORAL 20171010 OTC MONOGRAPH FINAL part343 Achlis Laboratories ASPIRIN 325 mg/1 N 20181231 71477-010_b732ba4b-6daf-42ef-9e05-894a595e0e61 71477-010 HUMAN OTC DRUG Anti aging ample Adenosine LIQUID TOPICAL 20170601 UNAPPROVED DRUG OTHER Get Beauty ADENOSINE .012 g/30mL N 20181231 71477-020_f4ef4e5c-722a-4afc-bed7-f5f4f6fbbda6 71477-020 HUMAN OTC DRUG Anti aging Adenosine CREAM TOPICAL 20170601 UNAPPROVED DRUG OTHER Get Beauty ADENOSINE .012 g/30mL N 20181231 71480-831_518828aa-6f64-5656-e054-00144ff88e88 71480-831 HUMAN OTC DRUG Frankie Avalons Zero Pain Roll On CAPSAICIN CREAM TOPICAL 20170608 OTC MONOGRAPH NOT FINAL part348 Frankie Avalon's Venus Ltd. CAPSAICIN .25 mg/mL N 20181231 71481-100_52684dc0-ae16-743a-e054-00144ff88e88 71481-100 HUMAN OTC DRUG Rugby Cooling Pain MENTHOL GEL TOPICAL 20170610 OTC MONOGRAPH NOT FINAL part348 Bio V Pharma Inc. MENTHOL 40 mg/mL N 20181231 71483-0001_60e74fb5-d4b9-79a0-e053-2a91aa0a4eed 71483-0001 HUMAN OTC DRUG TERADIA THE LIQUIDDIAMOND SUNSCREEN SPF50 Ethylhexyl Methoxycinnamate, Homosalate, Ethylhexyl Salicylate CREAM TOPICAL 20171220 OTC MONOGRAPH FINAL part352 NanoDia Lab Co Ltd OCTINOXATE; HOMOSALATE; OCTISALATE 7; 6; 4.5 g/100mL; g/100mL; g/100mL N 20181231 71483-0002_60d3f3b0-b1df-629a-e053-2991aa0aec24 71483-0002 HUMAN OTC DRUG TERADIA DIAMOND INTENSIVE HYDROGEL EYE Niacinamide, Adenosine PATCH TOPICAL 20171220 UNAPPROVED DRUG OTHER NanoDia Lab Co Ltd ADENOSINE; NIACINAMIDE .04; 3 g/100g; g/100g N 20181231 71483-0003_60e7a680-b350-7380-e053-2a91aa0a412f 71483-0003 HUMAN OTC DRUG TERADIA DIAMOND WATER MASK Niacinamide, Adenosine LIQUID TOPICAL 20171220 UNAPPROVED DRUG OTHER NanoDia Lab Co Ltd ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71483-0004_60e7781a-4859-f173-e053-2991aa0aca3a 71483-0004 HUMAN OTC DRUG TERADIA MILK SKIN CREAMPAD Niacinamide, Adenosine CREAM TOPICAL 20171220 UNAPPROVED DRUG OTHER NanoDia Lab Co Ltd ADENOSINE; NIACINAMIDE .04; 2 g/100g; g/100g N 20181231 71484-0001_520eb908-5f1e-4426-e054-00144ff8d46c 71484-0001 HUMAN OTC DRUG MIRACLE SOS BLACK Moringa Oleifera Leaf Extract, Bamboo Charcoal Powder, SOAP TOPICAL 20170501 UNAPPROVED DRUG OTHER Ddoruroo Co., Ltd. MORINGA OLEIFERA LEAF; ACTIVATED CHARCOAL 33.8; .7 g/100g; g/100g N 20181231 71484-0002_525c5c45-757b-58d4-e054-00144ff88e88 71484-0002 HUMAN OTC DRUG MIRACLE SOS GOLD Moringa Oleifera Leaf Extract SOAP TOPICAL 20170501 UNAPPROVED DRUG OTHER Ddoruroo Co., Ltd. MORINGA OLEIFERA LEAF 33.8 g/100g N 20181231 71484-0003_60a8918a-296b-b54c-e053-2a91aa0ab206 71484-0003 HUMAN OTC DRUG Dr. A Anti Pollution Pollustop Ato glycerin CREAM TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part347 Ddoruroo Co., Ltd. GLYCERIN 5 g/100mL N 20181231 71484-0005_60a90fbb-412e-43ba-e053-2a91aa0a1ee0 71484-0005 HUMAN OTC DRUG Miracle SOS Green glycerin SOAP TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part347 Ddoruroo Co., Ltd. GLYCERIN 1 g/100g N 20181231 71484-0006_60bf843a-d9cc-3504-e053-2a91aa0ae2c6 71484-0006 HUMAN OTC DRUG Dr. B Anti Pollution Bubble Mask glycerin LIQUID TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part347 Ddoruroo Co., Ltd. GLYCERIN 4 g/100mL N 20181231 71484-0007_60a95baf-6931-46f2-e053-2991aa0a81d2 71484-0007 HUMAN OTC DRUG Fall in Rub (Love) Hand glycerin CREAM TOPICAL 20171219 OTC MONOGRAPH NOT FINAL part347 Ddoruroo Co., Ltd. GLYCERIN 5 g/100g N 20181231 71487-101_2b0c8939-b0ad-4ef6-99e2-fafe341ec0ed 71487-101 HUMAN OTC DRUG SG Plus Repellent Aroma Mist Icaridin LIQUID TOPICAL 20170627 UNAPPROVED DRUG OTHER HANKOOK SAMGONG CO.,LTD ICARIDIN 2.1 g/30mL N 20181231 71489-001_8c2bb4cb-3a5e-4247-88c7-36bd9bf4566a 71489-001 HUMAN OTC DRUG Safe Hands Hand Sanitizer with Alcohol ALCOHOL GEL CUTANEOUS 20170615 OTC MONOGRAPH NOT FINAL part333E Celeste Industries Corporation ALCOHOL .625 mL/mL N 20181231 71489-002_fd33da5c-36f5-4b7e-a9d7-51d2dae68bf4 71489-002 HUMAN OTC DRUG Safe Hands Foaming Hand Sanitizer Alcohol Free BENZALKONIUM CHLORIDE LIQUID CUTANEOUS 20170626 OTC MONOGRAPH NOT FINAL part333E Celeste Industries Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 71489-003_06c34aae-57ff-443a-a98b-aff1960ae941 71489-003 HUMAN OTC DRUG Safe Hands Hand Sanitizer Alcohol Free BENZALKONIUM CHLORIDE GEL CUTANEOUS 20170705 OTC MONOGRAPH NOT FINAL part333E Celeste Industries Corporation BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 71489-004_e1bf5765-7ff2-4ebf-838e-dae12aacbcae 71489-004 HUMAN OTC DRUG Safe Hands Antibacterial Liquid Hand TRICLOSAN SOAP CUTANEOUS 20170703 20180930 OTC MONOGRAPH NOT FINAL part333E Celeste Industries Corporation TRICLOSAN 2 mg/mL N 20181231 71489-005_c51d5392-3985-4f10-a87c-5ce86716ab42 71489-005 HUMAN OTC DRUG Sani-Com Pre-Moistened, Multi-Purpose Cleaning Towel Benzalkonium Chloride CLOTH CUTANEOUS 20170721 OTC MONOGRAPH NOT FINAL part333E Celeste Industries Corporation BENZALKONIUM CHLORIDE 1 mg/1 N 20181231 71490-001_0da3c877-7e88-46ef-8246-4f9febda6e3f 71490-001 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Lemon Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-002_28eb1220-7054-4533-a212-3522559e1e25 71490-002 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Kiwi Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-003_b6141d3c-cee6-429b-be77-e38f24ee3572 71490-003 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Red Fruits Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-004_47ac0527-80c5-4203-b950-c696c896d315 71490-004 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Papaya Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-005_741d9f82-084e-429c-b6ed-7434f7572bbd 71490-005 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Marine Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-006_2baae3b9-96af-48ca-8aa1-98cb2e5418e6 71490-006 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Damask Rose Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-007_63cfae31-f7c2-4cb8-ab3a-a342613ec751 71490-007 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Jasmine Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-008_6d999c9e-e439-499e-9dad-7da19ef286e1 71490-008 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Green Tea and Cucumber Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-009_fc5f0930-f5b9-4cc7-99e9-44a9285f5d12 71490-009 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Oud Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-010_58047c97-9a46-4896-a940-46f9311c3be8 71490-010 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Blue Flowers Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-011_efc341f5-a1c7-4bbd-9d83-365ba7c356ce 71490-011 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Passion Flower Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-012_d0da7143-ab52-4ffa-b578-24eb8ec8dd37 71490-012 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Fragrance Free Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-013_3a3a9c5a-ede6-45a7-b04d-cea93176b24e 71490-013 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Wild Berry Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-014_24820f46-351c-4009-aca1-4fe3c0f2d602 71490-014 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Together in love Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-015_262f89ed-4a45-4c6b-b971-188692795f46 71490-015 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Lemon With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-016_6155522d-5f83-4ec7-ad53-67e5a484036a 71490-016 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Kiwi With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-017_ff17c268-65b4-4dc2-85e1-c47e05cbbb2c 71490-017 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Red Fruits With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-018_1eaa9920-2c8e-4ec2-8299-5e4c9594caa4 71490-018 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Papaya with Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-019_0474f83d-7d56-4011-966d-2b2f53b5691b 71490-019 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Marine With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-020_9bae1ffe-6634-4f42-a47e-eccb2770e8d7 71490-020 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Damask Rose With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-021_0d0c0ce2-88e1-4594-80c3-5779c28dca36 71490-021 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Jasmine With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-022_2ea82a37-5152-4534-9c7b-23fd9b0f423c 71490-022 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Green Tea and Cucumber With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-023_afaf0460-9d3f-4cd6-9795-29ea407c8f33 71490-023 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Oud With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-024_3f75e134-5fe0-4e2b-a28d-7cb9e74f441b 71490-024 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Blue Flowers With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-025_455815b2-0a5c-404b-8f48-c1643d47af8d 71490-025 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Passion Flower With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-026_955ff9b3-926e-4143-9416-4f0db923c038 71490-026 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Fragrance Free With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-027_888e0059-ef6e-4723-aa0c-e536022a7d8a 71490-027 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Wild Berry With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-028_0c27c626-6091-42df-b9c2-3e2afbc70fc6 71490-028 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel With Vitamin Beads Together in love With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-029_abf26a59-15ff-40e9-8e11-7e7c234c6289 71490-029 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Gold Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-030_9af2bc1e-0dbc-475c-a23d-ba617331a50f 71490-030 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads Gold With Silicon Holder Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-031_684af570-e751-45f4-86d4-275592fe32e1 71490-031 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults Dooh Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-032_f03ff2ec-9ec2-45c4-b395-6c2b5809c762 71490-032 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults FiLo Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-033_5d4e0956-9ba1-470d-9969-9cc01e3566f7 71490-033 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults Bitty and Mitty Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-034_c9180a3a-307d-4c6f-b7e5-b8a4ac1929af 71490-034 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults BiBo Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-035_5f3e6289-ca7b-4d5e-b515-bb77a0e8d3a4 71490-035 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults MiDo Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-036_d7574d04-4daa-4ced-8e9b-a379332624cc 71490-036 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults Gito Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-037_d9654543-490e-4ecf-8046-b3af72d6bbbf 71490-037 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults NiNo Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-038_a0e5706e-66c1-41e6-ac3c-6813af7b0e78 71490-038 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel with Vitamin Beads For Kids and Adults Kitty Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-039_95423749-879c-4971-b617-e9e26c7830e3 71490-039 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel LEMON VERBENA FRAGRANCE Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-040_13ac5b14-3f30-4d86-a0d1-b3ecbd208c6a 71490-040 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel FRESH MARACUJA FRAGRANCE Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-041_962f5204-3295-4786-92b0-55e369851c5d 71490-041 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel FRESH LEMON FRAGRANCE Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71490-042_c56333c5-679f-42e0-ae21-03b3ff42babe 71490-042 HUMAN OTC DRUG HiGeen Antiseptic Hand Sanitizer Gel Fragrance Free Ethyl alcohol GEL TOPICAL 20170918 OTC MONOGRAPH NOT FINAL part333A SUKHTIAN-HTM ( HOUSEHOLDS & TOILETRIES MFG.CO) ALCOHOL 70 mL/100mL N 20181231 71491-100_5780c9e4-5dd6-270c-e053-2a91aa0a36ba 71491-100 HUMAN OTC DRUG Viabecline TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20170614 OTC MONOGRAPH FINAL part333B Accuria, LLC TETRACYCLINE HYDROCHLORIDE 30 mg/mL N 20181231 71496-0001_5389c38c-3091-602e-e054-00144ff8d46c 71496-0001 HUMAN OTC DRUG Moisture Bound Tremella Fuciformis Whole, Niacinamide, Adenosine, Ceramide CREAM TOPICAL 20170705 UNAPPROVED DRUG OTHER ARI&J Inc ADENOSINE; TREMELLA FUCIFORMIS WHOLE; CERAMIDE NP; NIACINAMIDE .04; .1; .01; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 71496-0002_538a6075-6d26-095d-e054-00144ff8d46c 71496-0002 HUMAN OTC DRUG Energy Boosting Toner Tremella Fuciformis Whole, Adenosine, Ceramide LIQUID TOPICAL 20170705 UNAPPROVED DRUG OTHER ARI&J Inc ADENOSINE; TREMELLA FUCIFORMIS WHOLE; CERAMIDE NP .04; .1; .01 g/100mL; g/100mL; g/100mL N 20181231 71496-0003_5326ae14-eb98-1351-e054-00144ff8d46c 71496-0003 HUMAN OTC DRUG Waterful Sun Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane GEL TOPICAL 20170630 OTC MONOGRAPH NOT FINAL part352 ARI&J Inc OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 7; 5; 4.5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 71497-010_15c89c14-9ee4-4941-bf36-b0ebb8690ab0 71497-010 HUMAN OTC DRUG LabNo 4SP Safe Tone Up Sun Titanium Dioxide CREAM TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 KB Lab Co., Ltd. TITANIUM DIOXIDE 1.26 g/50mL N 20181231 71497-020_7b2a7624-82e6-4eda-af8b-32bcde6533d4 71497-020 HUMAN OTC DRUG LabNo 4SP Safe Natural Tone BB Cushion TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 KB Lab Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 1.6; .26 g/14g; g/14g N 20181231 71497-030_a8cebdbb-e97a-4418-943d-3befcbc2df2b 71497-030 HUMAN OTC DRUG LabNo 4SP Safe Bright Tone BB Cushion TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 KB Lab Co., Ltd. TITANIUM DIOXIDE; ZINC OXIDE 1.6; .26 g/14g; g/14g N 20181231 71498-010_40b668af-fed3-43d2-ac89-c01fb038f831 71498-010 HUMAN OTC DRUG SOROCI Morning Calming Adenosine CREAM TOPICAL 20170601 UNAPPROVED DRUG OTHER Onsaemiro Co., Ltd. ADENOSINE .002 g/10g N 20181231 71498-020_d6b60895-d84c-44e3-92b0-1ba1e3642997 71498-020 HUMAN OTC DRUG SOROCI Morning Drizzle Bucket Mist Witch Hazel SPRAY TOPICAL 20171201 OTC MONOGRAPH FINAL part347 Onsaemiro Co.,Ltd. WITCH HAZEL 73.9 g/150mL N 20181231 71498-030_45c4e311-801f-4e56-99cc-888ec1f6147e 71498-030 HUMAN OTC DRUG SOROCI Morning Drizzle Calming Adenosine CREAM TOPICAL 20171201 UNAPPROVED DRUG OTHER Onsaemiro Co.,Ltd. ADENOSINE .01 g/50g N 20181231 71498-040_2c66183d-8c22-4d79-9ecf-3066ea1d2a49 71498-040 HUMAN OTC DRUG SOROCI Calming Essence Propolis LIQUID TOPICAL 20171201 UNAPPROVED DRUG OTHER Onsaemiro Co.,Ltd. PROPOLIS WAX .03 g/30mL N 20181231 71498-050_1d3827d2-5294-4b24-9bb7-abd75c0d0647 71498-050 HUMAN OTC DRUG SOROCI NMF Serum Lecithin CREAM TOPICAL 20171201 UNAPPROVED DRUG OTHER Onsaemiro Co.,Ltd. LECITHIN, SOYBEAN .06 g/30mL N 20181231 71502-001_7156cc2a-ca84-42d9-8e30-e6815403edba 71502-001 HUMAN OTC DRUG UNIWELL AQUA SUNCREAM Octinoxate, Octisalate CREAM TOPICAL 20170612 OTC MONOGRAPH NOT FINAL part352 uniwell LTD OCTINOXATE; OCTISALATE 3.5; 2.25 mg/50mL; mg/50mL N 20181231 71502-002_cfdcb8e6-9a69-4480-8587-28ad3b3ce5a8 71502-002 HUMAN OTC DRUG UNIWELL NATURAL ESSENCE DIMETHICONE EMULSION TOPICAL 20170612 OTC MONOGRAPH FINAL part347 uniwell LTD DIMETHICONE .937 mg/50mL N 20181231 71502-003_51e5fd7c-db4b-7367-e054-00144ff8d46c 71502-003 HUMAN OTC DRUG UNIWELL NATURAL Niacinamide, Adenosine CREAM TOPICAL 20170613 UNAPPROVED DRUG OTHER uniwell LTD NIACINAMIDE; ADENOSINE 1; .02 mg/50mL; mg/50mL N 20181231 71502-004_51e6003f-8ebb-23e5-e054-00144ff88e88 71502-004 HUMAN OTC DRUG UNIWELL NATURAL TONER Niacinamide, Adenosine LIQUID TOPICAL 20170613 UNAPPROVED DRUG OTHER uniwell LTD NIACINAMIDE; ADENOSINE 2.4; .048 mg/120mL; mg/120mL N 20181231 71503-001_22f48b77-9bfa-4bd6-9a8c-07525e386874 71503-001 HUMAN OTC DRUG Plu Refresh Peeling Facial Scrub Glycerin Scrub LOTION TOPICAL 20170626 UNAPPROVED DRUG OTHER Zivon Cosmetic Co., Ltd. GLYCERIN; ALLANTOIN 2; .1 g/100mL; g/100mL N 20181231 71503-002_0aa1a5ec-5f46-43bc-8848-51b857a28259 71503-002 HUMAN OTC DRUG Plu Moisture Honey Sugar Facial Scrub Glycerin Dimethicone Facial Scrub LOTION TOPICAL 20170713 UNAPPROVED DRUG OTHER Zivon Cosmetic Co., Ltd. GLYCERIN; DIMETHICONE 49.84; 1 g/100mL; g/100mL N 20181231 71503-003_2e1915ab-5a56-400b-a49e-bd1f7f796894 71503-003 HUMAN OTC DRUG Plu Body Scrub Berry Mix Glycerin Body Scrub LOTION TOPICAL 20170713 UNAPPROVED DRUG OTHER Zivon Cosmetic Co., Ltd. GLYCERIN .5 g/200mL N 20181231 71503-004_f61f0e0c-b5b9-481f-9381-ebd164582fe9 71503-004 HUMAN OTC DRUG Plu Body Scrub Coconut Glycerin Body Scrub LOTION TOPICAL 20170713 UNAPPROVED DRUG OTHER Zivon Cosmetic Co., Ltd. GLYCERIN 3.38 g/200mL N 20181231 71503-005_e213db29-6236-4e67-8892-a833232b17ed 71503-005 HUMAN OTC DRUG Plu Body Scrub Prestige Silk Edition Glycerin Body Scrub LOTION TOPICAL 20170713 UNAPPROVED DRUG OTHER Zivon Cosmetic Co., Ltd. GLYCERIN 6.84 g/180mL N 20181231 71503-006_4f5e81e1-3f3a-4901-bfe0-4ed39a0035df 71503-006 HUMAN OTC DRUG Plu Body Scrub Hazelnut Glycerin Body Scrub LOTION TOPICAL 20170713 UNAPPROVED DRUG OTHER Zivon Cosmetic Co., Ltd. GLYCERIN 1.22 g/200mL N 20181231 71503-007_4db483a9-bd85-4365-a281-9a8462de653c 71503-007 HUMAN OTC DRUG Plu Soft Peeling Facial Scrub Glycerin Facial Scrub LOTION TOPICAL 20170713 UNAPPROVED DRUG OTHER Zivon Cosmetic Co., Ltd. GLYCERIN; ALLANTOIN 2; .1 g/100mL; g/100mL N 20181231 71504-659_70a31910-e2a9-4ac0-82cf-212739be00b0 71504-659 HUMAN OTC DRUG BEARICAID ANTISEPTIC SKIN SANITIZING WIPES Ethyl alcohol CLOTH TOPICAL 20170614 OTC MONOGRAPH NOT FINAL part333E Knet Systems Corp. ALCOHOL 65.9 mL/100mL N 20181231 71509-000_531eca67-8a91-0448-e054-00144ff88e88 71509-000 HUMAN OTC DRUG Sting Relief Pad Benzocaine,ISOPROPYL ALCOHOL SWAB TOPICAL 20170621 OTC MONOGRAPH NOT FINAL part348 Hubei Chenteng Healthcare Co.,Ltd. BENZOCAINE; ISOPROPYL ALCOHOL 60; 600 mg/1; mg/1 N 20181231 71509-001_52a235a6-5048-663f-e054-00144ff88e88 71509-001 HUMAN OTC DRUG Povidone-Iodine Prep Pad POVIDONE-IODINE SWAB TOPICAL 20170622 OTC MONOGRAPH NOT FINAL part333A Hubei Chenteng Healthcare Co.,Ltd. POVIDONE-IODINE 100 mg/1 N 20181231 71509-002_52932ed6-c857-6564-e054-00144ff88e88 71509-002 HUMAN OTC DRUG Antiseptic Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20170622 OTC MONOGRAPH NOT FINAL part333A Hubei Chenteng Healthcare Co.,Ltd. BENZALKONIUM CHLORIDE 1 mg/1 N 20181231 71509-003_529224e8-bb5a-4398-e054-00144ff88e88 71509-003 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20170622 OTC MONOGRAPH NOT FINAL part333A Hubei Chenteng Healthcare Co.,Ltd. ISOPROPYL ALCOHOL 700 mg/1 N 20181231 71510-040_53a6cb96-07e9-0031-e054-00144ff88e88 71510-040 HUMAN OTC DRUG Whitening Anticavity Fluoride Tooth SODIUM MONOFLUOROPHOSPHATE CREAM DENTAL 20170705 OTC MONOGRAPH FINAL part355 Yangzhou Seeyes Fine Chemicals Co.,Ltd SODIUM MONOFLUOROPHOSPHATE 76 mg/181g N 20181231 71511-701_c154991b-7522-4d35-9ad7-1eede668c7b2 71511-701 HUMAN PRESCRIPTION DRUG Naprosyn Naproxen SUSPENSION ORAL 20180101 NDA NDA018965 Athena Bioscience NAPROXEN 125 mg/5mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20191231 71513-059_60eee7b0-780f-7c59-e053-2991aa0a08fe 71513-059 HUMAN OTC DRUG PL-0591 Flexi Hand Sanitizer GEL TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part333A Broder Bros Co., ALCOHOL 62 mL/62mL N 20181231 71513-100_60dc5066-f434-76b6-e053-2a91aa0a93e4 71513-100 HUMAN OTC DRUG PL-1807 TEE Sanitizer Spray . GEL TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part333A Broder Bros Co., ALCOHOL 62 mL/62mL N 20181231 71513-101_60dc5066-f434-76b6-e053-2a91aa0a93e4 71513-101 HUMAN OTC DRUG PL-1808 TEE Sanitizer Spray . GEL TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part333A Broder Bros Co., ALCOHOL 62 mL/62mL N 20181231 71513-180_60c989fe-2e7b-1325-e053-2a91aa0a0239 71513-180 HUMAN OTC DRUG Pouch Wipes Pouch Wipes SWAB TOPICAL 20170703 OTC MONOGRAPH NOT FINAL part333A Broder Bros Co., BENZALKONIUM CHLORIDE .13 g/100g N 20181231 71513-414_60eec9fd-5590-485b-e053-2991aa0a3f08 71513-414 HUMAN OTC DRUG PL-0591 Flexi Hand Sanitizer GEL TOPICAL 20170620 OTC MONOGRAPH NOT FINAL part333A Broder Bros Co., ALCOHOL 62 mL/62mL N 20181231 71513-849_60eece35-7708-4cf2-e053-2991aa0af6a8 71513-849 HUMAN OTC DRUG PL-1849 Collapsible Sunscreen CREAM TOPICAL 20170620 OTC MONOGRAPH FINAL part352 Broder Bros Co., OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; OXYBENZONE 7; 4; 4; 4 g/100g; g/100g; g/100g; g/100g N 20181231 71515-403_54367b35-c09e-6f3b-e054-00144ff8d46c 71515-403 HUMAN OTC DRUG DERMACED Deep Therapy Eczema OATMEAL CREAM TOPICAL 20170713 OTC MONOGRAPH FINAL part347 Dermaced LLC OATMEAL 10 mg/mL N 20181231 71515-832_531ff07b-f26a-293d-e054-00144ff8d46c 71515-832 HUMAN OTC DRUG Dermaced Maximum Strength Anti-Fungal UNDECYLENIC ACID LIQUID TOPICAL 20170629 OTC MONOGRAPH FINAL part333C Dermaced, LLC UNDECYLENIC ACID 250 mg/mL N 20181231 71516-001_51dde4fa-88d8-19cd-e054-00144ff88e88 71516-001 HUMAN OTC DRUG Hydrocortisone Hydrocortisone SHAMPOO TOPICAL 20170614 UNAPPROVED DRUG OTHER Dr Marder Skincare LLC HYDROCORTISONE 1 g/100mL N 20181231 71516-002_51de2258-2a2c-222b-e054-00144ff88e88 71516-002 HUMAN OTC DRUG Zinc Pyrithione Zinc Pyrithione SHAMPOO TOPICAL 20170614 UNAPPROVED DRUG OTHER Dr Marder Skincare LLC PYRITHIONE ZINC 1 g/100mL N 20181231 71517-001_53f8af30-7069-4a5b-e054-00144ff88e88 71517-001 HUMAN OTC DRUG minoxidil solution minoxidil solution SOLUTION TOPICAL 20170629 ANDA ANDA075598 Nutrastim Hair LLC MINOXIDIL 20 g/mL N 20181231 71520-002_5f3a4946-91fb-3ccf-e053-2a91aa0a1b39 71520-002 HUMAN OTC DRUG BELLAVIE ARNICORE Arnica Montana TABLET, CHEWABLE ORAL 20170614 UNAPPROVED HOMEOPATHIC NYC Medical Practice PC ARNICA MONTANA 30 [hp_C]/1 N 20181231 71521-678_5fb6cd53-765f-0f2e-e053-2a91aa0a621b 71521-678 HUMAN OTC DRUG XZM CARE Colloidal oatmeal CREAM TOPICAL 20170721 OTC MONOGRAPH FINAL part347 Lavior Inc. OATMEAL 1 g/100g N 20181231 71521-777_5fb6cd53-766e-0f2e-e053-2a91aa0a621b 71521-777 HUMAN OTC DRUG D-Care Allantoin GEL TOPICAL 20170801 OTC MONOGRAPH FINAL part347 Lavior Inc. ALLANTOIN .5 g/100g N 20181231 71521-876_5fb6da96-b663-6010-e053-2991aa0ac377 71521-876 HUMAN OTC DRUG W-Care Allantoin GEL TOPICAL 20170731 OTC MONOGRAPH FINAL part347 Lavior Inc. ALLANTOIN .5 g/100g N 20181231 71522-834_531fbc08-98bb-2a8f-e054-00144ff88e88 71522-834 HUMAN OTC DRUG Amazonic Natural Sunscreen SPF 30 Broad Spectrum UVA/UVB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170628 OTC MONOGRAPH NOT FINAL part352 Amazonic Products TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/g; mg/g N 20181231 71523-833_531eb1db-2e8f-3e76-e054-00144ff8d46c 71523-833 HUMAN OTC DRUG Debbies Down and Dirty Deep Tissue Joint and Muscle MENTHOL CREAM TOPICAL 20170628 OTC MONOGRAPH NOT FINAL part348 DD&D Manufacturing Co., Ltd MENTHOL 100 mg/mL N 20181231 71524-101_9192ff69-a7c2-4fb6-a427-85a0dad2f1bf 71524-101 HUMAN OTC DRUG CONSIOUS SUNSCREEN, PROTECT-RESPECT SPF-40 ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20170725 OTC MONOGRAPH NOT FINAL part352 SOLID SUN LOGISTICS ZINC OXIDE; TITANIUM DIOXIDE 7; 5 g/100mL; g/100mL N 20181231 71524-102_925a8e46-8d85-4eef-8233-95e2816f15a1 71524-102 HUMAN OTC DRUG CONSIOUS SUNSCREEN, PROTECT-RESPECT, FACE SPF-40 ZINC OXIDE, TITANIUM DIOXIDE STICK TOPICAL 20170725 OTC MONOGRAPH NOT FINAL part352 SOLID SUN LOGISTICS ZINC OXIDE; TITANIUM DIOXIDE 17; 3 g/100mL; g/100mL N 20181231 71527-3492_5e84a8cb-2920-1f8f-e053-2a91aa0ad717 71527-3492 HUMAN OTC DRUG Trulyclear The One-Step Acne Solution Salicylic Acid SOAP TOPICAL 20170626 OTC MONOGRAPH FINAL part333D RK RESPONSE INC. SALICYLIC ACID 1 g/100g N 20181231 71529-835_531ff07b-f247-293d-e054-00144ff8d46c 71529-835 HUMAN OTC DRUG Christina Moss Naturals Natural Sunscreen SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20170629 OTC MONOGRAPH NOT FINAL part352 Christina Moss Naturals, LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71530-024_60a4bb34-d0e4-6b7a-e053-2a91aa0ae567 71530-024 HUMAN OTC DRUG Nano Pure Benzalkonium Chloride LIQUID TOPICAL 20170626 OTC MONOGRAPH NOT FINAL part333A Nano Global BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 71537-001_62e208c2-8745-47bf-bacc-8f64d67f8d0d 71537-001 HUMAN OTC DRUG Acne Treatment Pads SALICYLIC ACID PATCH TOPICAL 20170623 OTC MONOGRAPH FINAL part333D Huijing (Shanghai) Bio-tech Co., Ltd SALICYLIC ACID 2 g/100mL N 20181231 71537-002_853d3db2-b928-4915-a6a3-5f2363e11e24 71537-002 HUMAN OTC DRUG Cupcake ethyl alcohol LIQUID TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part333A Huijing (Shanghai) Bio-tech Co., Ltd ALCOHOL 65 mL/100mL N 20181231 71537-003_2743b8f9-4a84-4614-8d6f-8f2e2f851020 71537-003 HUMAN OTC DRUG Cotton Candy ethyl alcohol LIQUID TOPICAL 20170623 OTC MONOGRAPH NOT FINAL part333A Huijing (Shanghai) Bio-tech Co., Ltd ALCOHOL 65 mL/100mL N 20181231 71537-004_84f1caba-9642-4c81-aeb7-c2254163c766 71537-004 HUMAN OTC DRUG very vanilla Ethyl Alcohol GEL TOPICAL 20170626 OTC MONOGRAPH NOT FINAL part333A Huijing (Shanghai) Bio-tech Co., Ltd ALCOHOL 65 mL/100mL N 20181231 71537-005_88460839-2a41-4c5d-8349-3ac83ecde2dd 71537-005 HUMAN OTC DRUG Assured Bug Bite Relief SODIUM BICARBONATE LIQUID TOPICAL 20170801 OTC MONOGRAPH FINAL part347 Huijing (Shanghai) Bio-tech Co., Ltd SODIUM BICARBONATE 5 g/100mL N 20181231 71538-001_1f589534-6b9f-46cd-bffa-07ef1bcc9055 71538-001 HUMAN OTC DRUG Herbal Skin Toner Glycerin Toner SOLUTION TOPICAL 20170717 UNAPPROVED DRUG OTHER NANONATURE GLYCERIN 15.96 g/120mL N 20181231 71538-002_325c81ea-5037-4b9b-99ab-5aef8474bf4e 71538-002 HUMAN OTC DRUG Ultra Moisturizing Essence Glycerin Essence SOLUTION TOPICAL 20170717 UNAPPROVED DRUG OTHER NANONATURE GLYCERIN 12.3 g/100mL N 20181231 71538-003_ed1552cb-6687-4f43-8d70-fea174e7ee24 71538-003 HUMAN OTC DRUG Renewal Serum Glycerin Serum SOLUTION TOPICAL 20170717 UNAPPROVED DRUG OTHER NANONATURE GLYCERIN 2.6 g/40mL N 20181231 71538-004_254d05e5-d70a-41f8-9644-8d91c4b17649 71538-004 HUMAN OTC DRUG Anti Wrinkle Eye Serum Glycerin Serum SOLUTION TOPICAL 20170717 UNAPPROVED DRUG OTHER NANONATURE GLYCERIN 1.65 g/120mL N 20181231 71538-005_9e4e36f3-9d02-4977-b3f9-b02370ca8cfe 71538-005 HUMAN OTC DRUG Baby Essence Glycerin Essence SOLUTION TOPICAL 20170717 UNAPPROVED DRUG OTHER NANONATURE GLYCERIN 9.5 g/100mL N 20181231 71538-006_35a84d11-cc31-4125-8685-9f5e8ba8b0e7 71538-006 HUMAN OTC DRUG Baby Oil Glycerin Oil SOLUTION TOPICAL 20170717 UNAPPROVED DRUG OTHER NANONATURE GLYCERIN 11 g/100mL N 20181231 71538-007_d0052173-c684-44a2-b63b-ff2488c4f76d 71538-007 HUMAN OTC DRUG Body Hair Moisturizing Oil Glycerin Oil SOLUTION TOPICAL 20170717 UNAPPROVED DRUG OTHER NANONATURE GLYCERIN 19.6 g/200mL N 20181231 71540-0001_52fc5fbd-81b0-4f34-e054-00144ff8d46c 71540-0001 HUMAN OTC DRUG DR.SERSE Serum GLYCERIN GEL TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part347 TS INTERNATIONAL GLYCERIN 1 g/100mL N 20181231 71547-101_543b279d-09c9-0b90-e054-00144ff8d46c 71547-101 HUMAN OTC DRUG Green Toner Panthenol, Niacinamide LIQUID TOPICAL 20170713 UNAPPROVED DRUG OTHER Iruri Nature Handmade Soap & Cosmetic Inc NIACINAMIDE; PANTHENOL .9; .3 g/30mL; g/30mL N 20181231 71547-102_543b6f9c-35ee-19da-e054-00144ff8d46c 71547-102 HUMAN OTC DRUG EM Shea Butter Cream Shea Butter CREAM TOPICAL 20170713 UNAPPROVED DRUG OTHER Iruri Nature Handmade Soap & Cosmetic Inc SHEA BUTTER 5.14 g/20mL N 20181231 71547-103_543bcd07-7ea2-0e74-e054-00144ff88e88 71547-103 HUMAN OTC DRUG Green Allantoin LOTION TOPICAL 20170713 UNAPPROVED DRUG OTHER Iruri Nature Handmade Soap & Cosmetic Inc ALLANTOIN .4 g/20mL N 20181231 71547-104_54c69554-0b0b-27e7-e054-00144ff8d46c 71547-104 HUMAN OTC DRUG Green Sunblock Zinc oxide CREAM TOPICAL 20170720 OTC MONOGRAPH NOT FINAL part352 Iruri Nature Handmade Soap & Cosmetic Inc ZINC OXIDE 1.6 g/20mL N 20181231 71547-105_55170e26-0978-6455-e054-00144ff8d46c 71547-105 HUMAN OTC DRUG Yellow Toner Royal Jelly LIQUID TOPICAL 20170724 UNAPPROVED DRUG OTHER Iruri Nature Handmade Soap & Cosmetic Inc ROYAL JELLY .15 g/30mL N 20181231 71547-107_5516b784-23bf-2582-e054-00144ff88e88 71547-107 HUMAN OTC DRUG Yellow Sunblock Zinc oxide CREAM TOPICAL 20170724 OTC MONOGRAPH NOT FINAL part352 Iruri Nature Handmade Soap & Cosmetic Inc ZINC OXIDE 1.6 g/20mL N 20181231 71547-108_55171085-0c55-620b-e054-00144ff8d46c 71547-108 HUMAN OTC DRUG Purple Toner Panthenol, Niacinamide LIQUID TOPICAL 20170724 UNAPPROVED DRUG OTHER Iruri Nature Handmade Soap & Cosmetic Inc PANTHENOL .3 g/30mL N 20181231 71547-109_552a0785-6f38-658b-e054-00144ff88e88 71547-109 HUMAN OTC DRUG Purple Allantoin LOTION TOPICAL 20170725 UNAPPROVED DRUG OTHER Iruri Nature Handmade Soap & Cosmetic Inc ALLANTOIN .4 g/20mL N 20181231 71547-110_552b1532-4a4f-2984-e054-00144ff8d46c 71547-110 HUMAN OTC DRUG Yellow Shea Butter, Allantoin LOTION TOPICAL 20170724 UNAPPROVED DRUG OTHER Iruri Nature Handmade Soap & Cosmetic Inc ALLANTOIN; SHEA BUTTER .4; 2.2 g/20mL; g/20mL N 20181231 71547-111_552ad082-747c-1b97-e054-00144ff8d46c 71547-111 HUMAN OTC DRUG Purple Sunblock Zinc oxide CREAM TOPICAL 20170725 OTC MONOGRAPH NOT FINAL part352 Iruri Nature Handmade Soap & Cosmetic Inc ZINC OXIDE 1.6 g/20mL N 20181231 71551-0001_52fb9365-5c25-264a-e054-00144ff88e88 71551-0001 HUMAN OTC DRUG SOLLUME ESTHE REPAIR SERUM NIACINAMIDE, ADENOSINE GEL TOPICAL 20170501 UNAPPROVED DRUG OTHER G&J Co., Ltd. ADENOSINE; NIACINAMIDE .04; 5 g/100mL; g/100mL N 20181231 71552-231_52a6d991-fefc-3df2-e054-00144ff8d46c 71552-231 HUMAN OTC DRUG Nuby Teething Gel Teething Gel GEL TOPICAL 20170628 OTC MONOGRAPH NOT FINAL part356 Europharma Concepts limited EUGENOL 8 mg/g N 20181231 71553-010_03f36f87-b82d-48a6-9fef-536501aa87e6 71553-010 HUMAN OTC DRUG PLUS153 Toothpast e Sodium monofluorophosphate PASTE, DENTIFRICE TOPICAL 20170601 OTC MONOGRAPH FINAL part355 SGS Inc. SODIUM MONOFLUOROPHOSPHATE .29 g/40g N 20181231 71555-002_5f30b29f-914b-496c-e053-2991aa0a5d4e 71555-002 HUMAN OTC DRUG Ez Massager 2 Original Menthol GEL TOPICAL 20170831 OTC MONOGRAPH NOT FINAL part348 BlackPort Distribution MENTHOL 2 g/100mL N 20181231 71555-004_5f30b29f-913f-496c-e053-2991aa0a5d4e 71555-004 HUMAN OTC DRUG Ez Massager 4 Extra Strength Menthol GEL TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part348 BlackPort Distribution MENTHOL 4 g/100mL N 20181231 71556-100_7c7d2d4c-0d59-43bc-913d-bbdc6bf96d4d 71556-100 HUMAN OTC DRUG Daily Protezione Broad Spectrum SPF30 Sunscreen Zinc oxide LOTION TOPICAL 20170710 OTC MONOGRAPH NOT FINAL part352 Pure on Purpose, LLC ZINC OXIDE 17.5 g/100g N 20181231 71556-200_f28f044a-8f26-4f10-91bf-79be9cc752a7 71556-200 HUMAN OTC DRUG Serum Crema Broad Spectrum SPF20 Sunscreen Zinc oxide LOTION TOPICAL 20170710 OTC MONOGRAPH NOT FINAL part352 Pure on Purpose, LLC ZINC OXIDE 13.5 g/100g N 20181231 71559-201_da428258-9402-4237-b3e5-7c455db51404 71559-201 HUMAN OTC DRUG Texas Knows Allergy Relief Allium Cepa, Ambrosia Artemisiaefolia, Aralia Racemosa, Cineraria Maritima, Histaminum Hydrochloricum, Luffa Operculata, Naphthalinum, Populus Candicans, Quercus Glandium Spiritus, Salix Nigra, Sambucus Nigra, Thuja Occidentalis, Ulmus Procera, Flos, Uritca Urens, Anthoxanthum, Candida Albicans. LIQUID ORAL 20170731 UNAPPROVED HOMEOPATHIC NaturoDRJ Enterprises ONION; AMBROSIA ARTEMISIIFOLIA; ARALIA RACEMOSA ROOT; JACOBAEA MARITIMA; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; NAPHTHALENE; POPULUS BALSAMIFERA LEAF BUD; QUERCUS ROBUR NUT; SALIX NIGRA BARK; SAMBUCUS NIGRA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; ULMUS MINOR FLOWERING TWIG; URTICA URENS; ANTHOXANTHUM ODORATUM; CANDIDA ALBICANS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 15 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 71559-202_152d0e5d-b450-4f29-ab56-bb459eb5e3db 71559-202 HUMAN OTC DRUG Texas Knows Allergy Relief For Kids Allium Cepa, Ambrosia Artemisiaefolia, Aralia Racemosa, Cineraria Maritima, Histaminum Hydrochloricum, Luffa Operculata, Naphthalinum, Populus Candicans, Quercus Glandium Spiritus, Salix Nigra, Sambucus Nigra, Thuja Occidentalis, Ulmus Procera Flos, Urtica Urens, Anthoxanthum, Candida Albicans. LIQUID ORAL 20170731 UNAPPROVED HOMEOPATHIC NaturoDRJ Enterprises ONION; AMBROSIA ARTEMISIIFOLIA; ARALIA RACEMOSA ROOT; JACOBAEA MARITIMA; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; NAPHTHALENE; POPULUS BALSAMIFERA LEAF BUD; QUERCUS ROBUR NUT; SALIX NIGRA BARK; SAMBUCUS NIGRA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; ULMUS PROCERA FLOWERING TWIG; URTICA URENS; ANTHOXANTHUM ODORATUM; CANDIDA ALBICANS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 15 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 71559-301_58990631-b2a0-45b0-bf84-00dac9d987a9 71559-301 HUMAN OTC DRUG Nature Knows Allergy Relief Allium Cepa, Ambrosia Artemisiaefolia, Aralia Racemosa, Cineraria Maritima, Histaminum Hydrochloricum, Luffa Operculata, Naphthalinum, Populus Candicans, Quercus Glandium Spiritus, Salix Nigra, Sambucus Nigra, Thuja Occidentalis, Ulmus Procera Flos, Urtica Urens, Anthoxanthum, Candida Albicans. LIQUID ORAL 20170731 UNAPPROVED HOMEOPATHIC NaturoDRJ Enterprises ONION; AMBROSIA ARTEMISIIFOLIA; ARALIA RACEMOSA ROOT; JACOBAEA MARITIMA; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; NAPHTHALENE; POPULUS BALSAMIFERA LEAF BUD; QUERCUS ROBUR NUT; SALIX NIGRA BARK; SAMBUCUS NIGRA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; ULMUS MINOR FLOWERING TWIG; URTICA URENS; ANTHOXANTHUM ODORATUM; CANDIDA ALBICANS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 15 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 71559-302_ab27b75a-155f-4a30-868c-44bf39703454 71559-302 HUMAN OTC DRUG Nature Knows Allergy Relief For Kids Allium Cepa, Ambrosia Artemisiaefolia, Aralia Racemosa, Cineraria Maritima, Histaminum Hydrochloricum, Luffa Operculata, Naphthalinum, Populus Candicans, Quercus Glandium Spiritus, Salix Nigra, Sambucus Nigra, Thuja Occidentalis, Ulmus Procera Flos, Urtica Urens, Anthoxanthum, Candida Albicans. LIQUID ORAL 20170731 UNAPPROVED HOMEOPATHIC NaturoDRJ Enterprises ONION; AMBROSIA ARTEMISIIFOLIA; ARALIA RACEMOSA ROOT; JACOBAEA MARITIMA; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; NAPHTHALENE; POPULUS BALSAMIFERA LEAF BUD; QUERCUS ROBUR NUT; SALIX NIGRA BARK; SAMBUCUS NIGRA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; ULMUS MINOR FLOWERING TWIG; URTICA URENS; ANTHOXANTHUM ODORATUM; CANDIDA ALBICANS 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 15; 15 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL N 20181231 71563-0400_5437ccae-587b-6be4-e054-00144ff88e88 71563-0400 HUMAN OTC DRUG AB Skincare Acne Spot Treatment Benzoyl Peroxide CREAM TOPICAL 20171009 OTC MONOGRAPH FINAL part333D Norris Ltd BENZOYL PEROXIDE 28.3 g/100g N 20181231 71566-100_355dbbd9-1802-4ecc-8116-b17f48954279 71566-100 HUMAN OTC DRUG Happy Cappy pyrithione zinc SHAMPOO TOPICAL 20171207 OTC MONOGRAPH FINAL part358H Pediatric Solutions, LLC PYRITHIONE ZINC .0095 g/mL N 20181231 71567-0001_53b161d4-eae6-3494-e054-00144ff8d46c 71567-0001 HUMAN OTC DRUG AQUATO BABY Dimethicone CREAM TOPICAL 20170705 OTC MONOGRAPH FINAL part347 ItoB Co.,Ltd DIMETHICONE 1 g/100mL N 20181231 71567-0002_53b32b17-26df-3953-e054-00144ff88e88 71567-0002 HUMAN OTC DRUG AQUATO BABY Glycerin LOTION TOPICAL 20170705 OTC MONOGRAPH NOT FINAL part347 ItoB Co.,Ltd GLYCERIN 6 g/100mL N 20181231 71567-0003_5dd4ea73-e637-7dc0-e053-2a91aa0a0e82 71567-0003 HUMAN OTC DRUG AQUATO PLUS MOISTURE Glycerin LOTION TOPICAL 20171113 OTC MONOGRAPH NOT FINAL part347 ItoB Co.,Ltd GLYCERIN 13 g/100mL N 20181231 71567-0004_5dd4ea73-e636-7dc0-e053-2a91aa0a0e82 71567-0004 HUMAN OTC DRUG AQUATO PLUS VITAL Glycerin CREAM TOPICAL 20171113 OTC MONOGRAPH NOT FINAL part347 ItoB Co.,Ltd GLYCERIN 11 g/100mL N 20181231 71567-0005_5dd673fb-118c-6e50-e053-2a91aa0afef0 71567-0005 HUMAN OTC DRUG AQUATO PLUS WATER BLOSSOM TOP TO TOE WASH Glycerin LIQUID TOPICAL 20171113 OTC MONOGRAPH NOT FINAL part347 ItoB Co.,Ltd GLYCERIN 3 g/100mL N 20181231 71568-0001_53888110-9708-2123-e054-00144ff8d46c 71568-0001 HUMAN OTC DRUG OR Serum GLYCERIN GEL TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part347 Korea Longrich International GLYCERIN 1 g/100mL N 20181231 71569-370_86a151a8-97ef-4a41-b4a2-0a76741d4310 71569-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20170711 OTC MONOGRAPH NOT FINAL part333A Jubilant, LLC ALCOHOL 70 mL/100mL N 20181231 71569-602_c081cb02-326b-48c3-8002-35fc0391ef69 71569-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part334 Jubilant, LLC MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 71569-664_bfdbfd7b-e684-43c8-9686-55b2ed58d5f9 71569-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 20170403 OTC MONOGRAPH NOT FINAL part356 Jubilant, LLC EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71573-102_f15b2ab1-dbb6-4cf7-a4b2-8bba45077be1 71573-102 HUMAN OTC DRUG Prosoria Psoriasis Treatment Salicylic Acid GEL TOPICAL 20171122 OTC MONOGRAPH FINAL part358H Nuvothera, Inc. SALICYLIC ACID 1.77 g/59mL N 20181231 71574-300_566917f5-1ff3-5861-e054-00144ff88e88 71574-300 HUMAN OTC DRUG Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOL GEL TOPICAL 20170722 OTC MONOGRAPH NOT FINAL part348 Village Pharma, LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 40; 10 mg/mL; mg/mL N 20181231 71574-400_55c53f81-9419-33e1-e054-00144ff8d46c 71574-400 HUMAN OTC DRUG Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOL PATCH TOPICAL 20170729 OTC MONOGRAPH NOT FINAL part348 Village Pharma, LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 40; 10 mg/g; mg/g N 20181231 71577-111_b084dd3f-d59b-4e03-8ab5-4edc8b7d3e80 71577-111 HUMAN OTC DRUG ACTIV O2 ACNE TREATMENT CLEANSING BAR Salicylic acid SOAP TOPICAL 20170928 OTC MONOGRAPH FINAL part333D Activ Ozone (pty) Ltd SALICYLIC ACID 2 g/100g N 20181231 71577-222_0fd1b938-1faf-424e-ac82-c8814ca5cdd4 71577-222 HUMAN OTC DRUG Activ O2 Acne Treatment Cream Sulfur CREAM TOPICAL 20170927 OTC MONOGRAPH FINAL part333D Activ Ozone (pty) Ltd SULFUR 10 g/100mL N 20181231 71577-333_a87aca13-e786-4f69-9f12-784e8cced06e 71577-333 HUMAN OTC DRUG Activ O2 Acne Treatment Salicylic acid LOTION TOPICAL 20170922 OTC MONOGRAPH FINAL part333D Activ Ozone (pty) Ltd SALICYLIC ACID 2 g/100mL N 20181231 71578-001_5556f698-44cb-38d8-e054-00144ff8d46c 71578-001 HUMAN OTC DRUG HAIR REGENERATOR Glycerin SOLUTION TOPICAL 20170727 OTC MONOGRAPH FINAL part347 NUGGELA & SULE SL GLYCERIN 4 mg/mL N 20181231 71578-002_5589d55f-ad96-6b80-e054-00144ff88e88 71578-002 HUMAN OTC DRUG HAIR REGENERATOR Glycerin SOLUTION TOPICAL 20170727 OTC MONOGRAPH FINAL part347 NUGGELA & SULE SL GLYCERIN 4 mg/mL N 20181231 71578-003_5589d55f-ada6-6b80-e054-00144ff88e88 71578-003 HUMAN OTC DRUG Effective Hair Strengthen Glycerin SOLUTION TOPICAL 20170727 OTC MONOGRAPH FINAL part347 NUGGELA & SULE SL GLYCERIN 4.97 mg/mL N 20181231 71578-004_559044e1-cf43-7112-e054-00144ff88e88 71578-004 HUMAN OTC DRUG Effective Hair Strengthen Glycerin SOLUTION TOPICAL 20170727 OTC MONOGRAPH FINAL part347 NUGGELA & SULE SL GLYCERIN 4.97 mg/mL N 20181231 71578-006_55920970-7aeb-4df8-e054-00144ff8d46c 71578-006 HUMAN OTC DRUG HAIR TREATMENT PREMIUM Glycerin SHAMPOO TOPICAL 20170727 OTC MONOGRAPH FINAL part347 NUGGELA & SULE SL GLYCERIN 3.88 mg/mL N 20181231 71580-0001_54180d10-b412-5932-e054-00144ff88e88 71580-0001 HUMAN OTC DRUG APRILSKIN MAGIC SNOW FIXING FOUNDATION 22 PINK BEIGE TITANIUM DIOXIDE, NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 APRILSKIN Co., Ltd. TITANIUM DIOXIDE; ADENOSINE; NIACINAMIDE 12.00736; .04; 2 g/100g; g/100g; g/100g N 20181231 71580-0002_542c2176-4947-467a-e054-00144ff88e88 71580-0002 HUMAN OTC DRUG APRILSKIN MAGIC SNOW FIXING FOUNDATION 23 NATURAL BEIGE TITANIUM DIOXIDE, NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170501 OTC MONOGRAPH NOT FINAL part352 APRILSKIN Co., Ltd. TITANIUM DIOXIDE; ADENOSINE; NIACINAMIDE 12.00736; .04; 2 g/100g; g/100g; g/100g N 20181231 71581-0001_54a4af1c-b05b-3d50-e054-00144ff8d46c 71581-0001 HUMAN OTC DRUG CASO SKIN VITA Artemisia Montana Pampan Extract LIQUID TOPICAL 20170501 UNAPPROVED DRUG OTHER CASO Dom Ltd. WORMWOOD 96.6 g/100mL N 20181231 71581-0002_54a56d3b-7d40-0f60-e054-00144ff88e88 71581-0002 HUMAN OTC DRUG CASO CANDIQ. PLUS Artemisia Montana Pampan Extract LIQUID TOPICAL 20170501 UNAPPROVED DRUG OTHER CASO Dom Ltd. WORMWOOD 96.6 g/100mL N 20181231 71581-0003_54a5fd04-1ddc-2c49-e054-00144ff88e88 71581-0003 HUMAN OTC DRUG CASO HAIR VITA Artemisia Montana Pampan Extract LIQUID TOPICAL 20170501 UNAPPROVED DRUG OTHER CASO Dom Ltd. WORMWOOD 96.6 g/100mL N 20181231 71582-001_34f79a14-5852-4d4d-97c9-5346193dd372 71582-001 HUMAN OTC DRUG Anti Fungal Coltrimazole LIQUID TOPICAL 20170922 OTC MONOGRAPH FINAL part333C Guangzhou Ertiantang Pharmaceutical Co.,Ltd CLOTRIMAZOLE 1 g/100mL N 20181231 71583-0001_54b8f2d0-5108-155b-e054-00144ff88e88 71583-0001 HUMAN OTC DRUG Carahen scalp revitalizing serum mist Salicylic Acid LIQUID TOPICAL 20170720 UNAPPROVED DRUG OTHER B.N.Trinity Co.,Ltd SALICYLIC ACID .2 g/100mL N 20181231 71583-0002_54b9d276-5002-2cc2-e054-00144ff8d46c 71583-0002 HUMAN OTC DRUG Carahen hair-loss recovery Salicylic Acid SHAMPOO TOPICAL 20170720 UNAPPROVED DRUG OTHER B.N.Trinity Co.,Ltd SALICYLIC ACID .3 g/100mL N 20181231 71584-0101_547cef39-3b73-64f1-e054-00144ff88e88 71584-0101 HUMAN OTC DRUG Alcohol Prep Pad isopropyl alcohol SWAB TOPICAL 20170717 OTC MONOGRAPH NOT FINAL part333A Guangdong Comfort Medical Products Co., Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 71584-0102_5480fdb0-a52b-0123-e054-00144ff88e88 71584-0102 HUMAN OTC DRUG PHARMACIST CHOICE ALCOHOL PREP PADS isopropyl alcohol SWAB TOPICAL 20170717 OTC MONOGRAPH NOT FINAL part333A Guangdong Comfort Medical Products Co., Ltd. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 71584-0103_548cc932-c4eb-3360-e054-00144ff88e88 71584-0103 HUMAN OTC DRUG BZK antiseptic towelette benzalkonium chloride SWAB TOPICAL 20170717 OTC MONOGRAPH NOT FINAL part333A Guangdong Comfort Medical Products Co., Ltd. BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 71584-0104_548cc932-c4f7-3360-e054-00144ff88e88 71584-0104 HUMAN OTC DRUG Povidone-iodine prep pad povidone-iodine SWAB TOPICAL 20170717 OTC MONOGRAPH FINAL part333C Guangdong Comfort Medical Products Co., Ltd. POVIDONE-IODINE 9.43 g/100g N 20181231 71584-0106_548d8155-946b-4e8c-e054-00144ff8d46c 71584-0106 HUMAN OTC DRUG Antiseptic Cleansing Wipes chlorhexidine gluconate SWAB TOPICAL 20170717 UNAPPROVED DRUG OTHER Guangdong Comfort Medical Products Co., Ltd. CHLORHEXIDINE GLUCONATE .0002 mg/mg N 20181231 71584-0107_548d9fb4-bd58-74c1-e054-00144ff8d46c 71584-0107 HUMAN OTC DRUG EYE WASH EYE WASH LIQUID OPHTHALMIC 20170717 OTC MONOGRAPH FINAL part349 Guangdong Comfort Medical Products Co., Ltd. WATER 99.1 mL/100mL N 20181231 71585-101_3603a51d-e595-4ca6-9ea2-be599617652c 71585-101 HUMAN OTC DRUG PREMIUM SUNSCREEN FACE SPF-50 ZINC OXIDE, OCTINOXATE STICK TOPICAL 20170829 OTC MONOGRAPH NOT FINAL part352 SALT AND STONE ZINC OXIDE; OCTINOXATE 15; 3 g/100g; g/100g N 20181231 71585-102_df99b96f-d7f4-4df0-83d0-2a44937c4bc9 71585-102 HUMAN OTC DRUG PREMIUM SUNSCREEN SPF-30 ZINC OXIDE, OCTINOXATE LOTION TOPICAL 20170829 OTC MONOGRAPH NOT FINAL part352 SALT AND STONE ZINC OXIDE; OCTINOXATE 10; 7 g/100mL; g/100mL N 20181231 71587-0001_551ee025-415a-24b5-e054-00144ff8d46c 71587-0001 HUMAN OTC DRUG Disinfectant Deodorant (Waterfos) oystershell, nano silver LIQUID TOPICAL 20170601 UNAPPROVED DRUG OTHER World Sung Ri Co., Ltd OSTREA EDULIS SHELL; SILVER 20; .01 g/100mL; g/100mL N 20181231 71587-0002_55573685-46f7-3ca8-e054-00144ff8d46c 71587-0002 HUMAN OTC DRUG Disinfectant Deodorant (Waterfos) oystershell, nano silver LIQUID TOPICAL 20170601 UNAPPROVED DRUG OTHER World Sung Ri Co., Ltd SILVER; OSTREA EDULIS SHELL .01; 20 g/100mL; g/100mL N 20181231 71588-0006_56ffc0e0-2694-3c90-e054-00144ff88e88 71588-0006 HUMAN OTC DRUG Vela Contour Neck and chin toning firming serum glycerin LIQUID TOPICAL 20170817 OTC MONOGRAPH NOT FINAL part347 EZEKIELCOSMETIC CO., LTD GLYCERIN 2 g/100mL N 20181231 71588-0007_57000702-2688-5a22-e054-00144ff8d46c 71588-0007 HUMAN OTC DRUG Vela Shape Resculpting Body firming toning tightening glycerin GEL TOPICAL 20170817 OTC MONOGRAPH FINAL part347 EZEKIELCOSMETIC CO., LTD GLYCERIN 15 g/100mL N 20181231 71588-0008_57002112-3162-496e-e054-00144ff88e88 71588-0008 HUMAN OTC DRUG Vela Shape Reaffirming Body firming toning tightening glycerin LIQUID TOPICAL 20170817 OTC MONOGRAPH FINAL part347 EZEKIELCOSMETIC CO., LTD GLYCERIN 15 g/100mL N 20181231 71588-0009_57002112-3164-496e-e054-00144ff88e88 71588-0009 HUMAN OTC DRUG Vela Shape ACTIV Body firming toning tightening glycerin CREAM TOPICAL 20170817 OTC MONOGRAPH NOT FINAL part347 EZEKIELCOSMETIC CO., LTD GLYCERIN 8 g/100mL N 20181231 71588-0011_578be57e-cee3-6ec6-e053-2991aa0aba1a 71588-0011 HUMAN OTC DRUG K Oxiderm OP Post Procedure skin care bruise Magnesium Ascorbyl Phosphate CREAM TOPICAL 20170817 UNAPPROVED DRUG OTHER EZEKIELCOSMETIC CO., LTD MAGNESIUM ASCORBYL PHOSPHATE .5 g/100mL N 20181231 71592-001_6148c5e0-d631-4d8d-8972-123bedffff66 71592-001 HUMAN OTC DRUG Antiperspirant Wipe for Women Aluminum Chlorohydrate SWAB TOPICAL 20170718 OTC MONOGRAPH FINAL part350 FlawlessWipes, LLC ALUMINUM CHLOROHYDRATE 15 g/100g N 20181231 71593-101_53122528-9a9b-4265-873e-dec8f1ee698a 71593-101 HUMAN OTC DRUG NERIUM SKINCARE NIGHT TREATMENT DIMETHICONE CREAM TOPICAL 20171206 OTC MONOGRAPH FINAL part347 ARG LABS DIMETHICONE 1.5 g/100mL N 20181231 71596-001_a5474014-caf4-4f63-921d-a8591ef20940 71596-001 HUMAN OTC DRUG BOTANIC HEAL boH IDEAL FOR MEN ALL DEFENSE MULTI CUSHION Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Cj Olivenetworks Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1; .8; .48 g/12g; g/12g; g/12g N 20181231 71596-002_75456225-3cfe-4572-a974-7a2e95e8f861 71596-002 HUMAN OTC DRUG Round Around Super Hydrating Dimethicone CREAM TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Cj Olivenetworks Co., Ltd DIMETHICONE .54 g/50mL N 20181231 71596-003_e547d789-ac94-4af2-b502-6dc4971e0c5d 71596-003 HUMAN OTC DRUG Round Around Essential Boosting Hydrator Dimethicone CREAM TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Cj Olivenetworks Co., Ltd DIMETHICONE 2.49 g/120mL N 20181231 71596-004_41312437-1edc-4ca8-8727-88913d672a70 71596-004 HUMAN OTC DRUG Round Around Comfort Hydrating Water GLYCERIN LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd GLYCERIN 4 g/200mL N 20181231 71596-005_ccc2ae63-df9b-47bc-96d3-ee4d0b9137b0 71596-005 HUMAN OTC DRUG ARE YOU THE REAL BRANCH MASK ADENOSINE PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd ADENOSINE .01 g/25g N 20181231 71596-006_0c563b9c-0495-4233-af55-dc1561403cab 71596-006 HUMAN OTC DRUG ARE YOU THE REAL SHREK MASK ADENOSINE PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd ADENOSINE .01 g/25g N 20181231 71596-007_68b50ae3-24d9-4d7c-97af-e487bf05cb94 71596-007 HUMAN OTC DRUG ARE YOU THE REAL CAT MASK ADENOSINE PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd ADENOSINE .01 g/25g N 20181231 71596-008_e997b9a9-8e00-4434-bf7c-d53be5e0e7e4 71596-008 HUMAN OTC DRUG ARE YOU THE REAL KUNG FU PANDA MASK NIACINAMIDE PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd NIACINAMIDE .5 g/25g N 20181231 71596-009_7bcb5b51-0ddd-4abf-b36a-c15e8cecdaad 71596-009 HUMAN OTC DRUG ARE YOU THE REAL POPPY MASK NIACINAMIDE PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd NIACINAMIDE .5 g/25g N 20181231 71596-010_cebf9fc7-ee3d-4dbe-b90b-94a9bca2e1c8 71596-010 HUMAN OTC DRUG WAKEMAKE LIP COASTER M03 RED ROCKET DIMETHICONE LIPSTICK TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Cj Olivenetworks Co., Ltd DIMETHICONE .91 g/4.5g N 20181231 71596-011_a0907b6b-2c1f-4866-afb6-187a8779c70d 71596-011 HUMAN OTC DRUG WAKEMAKE LIP COASTER M04 ORANGE RIDING DIMETHICONE LIPSTICK TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Cj Olivenetworks Co., Ltd DIMETHICONE .91 g/4.5g N 20181231 71596-012_d065727e-fa40-4edd-8dd5-49d06dddbb48 71596-012 HUMAN OTC DRUG WAKEMAKE LIP COASTER M05 DRAGON PINK DIMETHICONE LIPSTICK TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Cj Olivenetworks Co., Ltd DIMETHICONE .91 g/4.5g N 20181231 71596-013_576f8277-0d44-4abd-a99a-30347d5213e0 71596-013 HUMAN OTC DRUG WAKEMAKE LIP COASTER M08 SALMON TWIST DIMETHICONE LIPSTICK TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Cj Olivenetworks Co., Ltd DIMETHICONE .91 g/4.5g N 20181231 71596-014_628067af-30b3-44ee-ad7d-14412e6e1216 71596-014 HUMAN OTC DRUG WAKEMAKE LIP COASTER S01 GIANT BROWN OCTYLDODECANOL LIPSTICK TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd OCTYLDODECANOL .28 g/3.5g N 20181231 71596-015_53394a65-4141-4bfe-b081-b80db4a7bbee 71596-015 HUMAN OTC DRUG WAKEMAKE LIP COASTER S03 RED COASTER OCTYLDODECANOL LIPSTICK TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd OCTYLDODECANOL .28 g/3.5g N 20181231 71596-016_e86753db-7615-4807-8a8a-03919a0734ba 71596-016 HUMAN OTC DRUG WAKEMAKE LIP COASTER S06 GYRO PINK OCTYLDODECANOL LIPSTICK TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd OCTYLDODECANOL .28 g/3.5g N 20181231 71596-017_7126fb98-c5a7-4180-85c6-95c572fc73aa 71596-017 HUMAN OTC DRUG WAKEMAKE Whipping Tok Tint 01 Cherry Whip DIMETHICONE LIQUID TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Cj Olivenetworks Co., Ltd DIMETHICONE 3.77 g/7g N 20181231 71596-018_bc186eec-8d82-4781-a355-cae740a0d25c 71596-018 HUMAN OTC DRUG WAKEMAKE Whipping Tok Tint 02 Grapefruit Whip DIMETHICONE LIQUID TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Cj Olivenetworks Co., Ltd DIMETHICONE 3.77 g/7g N 20181231 71596-019_03318bf2-6db9-44ba-af28-5b2789d51629 71596-019 HUMAN OTC DRUG WAKEMAKE Whipping Tok Tint 03 Peach Whip DIMETHICONE LIQUID TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Cj Olivenetworks Co., Ltd DIMETHICONE 3.77 g/7g N 20181231 71596-020_a7520ed3-856a-4bcb-b9b5-1e1d9d46aa16 71596-020 HUMAN OTC DRUG WAKEMAKE Whipping Tok Tint 04 Rose Whip DIMETHICONE LIQUID TOPICAL 20170701 OTC MONOGRAPH FINAL part347 Cj Olivenetworks Co., Ltd DIMETHICONE 3.77 g/7g N 20181231 71596-021_7b6f5ee2-38fc-48d4-a94b-d80208d3d313 71596-021 HUMAN OTC DRUG WAKEMAKE WATERY TOK TINT 01 RED WATER DIMETHICONE LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd DIMETHICONE .05 g/7g N 20181231 71596-022_00f0e21d-04d9-4cc3-adb9-05cae79d4bbb 71596-022 HUMAN OTC DRUG WAKEMAKE WATERY TOK TINT 02 GRAPEFRUIT WATER DIMETHICONE LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd DIMETHICONE .05 g/7g N 20181231 71596-023_7e322ab2-e740-4474-84c5-06bcb7dd8b61 71596-023 HUMAN OTC DRUG WAKEMAKE WATERY TOK TINT 06 CHERRY WATER DIMETHICONE LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd DIMETHICONE .05 g/7g N 20181231 71596-024_a18ea1e3-7168-4676-aeb4-f47a3c087362 71596-024 HUMAN OTC DRUG WAKEMAKE WATERY TOK TINT 07 PEACH WATER DIMETHICONE LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd DIMETHICONE .05 g/7g N 20181231 71596-025_c168d2e8-f588-4322-bb57-6e12f19aea1a 71596-025 HUMAN OTC DRUG BOTANIC HEAL boH 360 Lifting Solu tion NIACINAMIDE, ADENOSINE PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 71596-026_8a628d09-9c6f-4256-827a-34f18fd58ca9 71596-026 HUMAN OTC DRUG BOTANIC HEAL boH Gauze Hydra Solu tion NIACINAMIDE, ADENOSINE PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd NIACINAMIDE; ADENOSINE .5; .01 g/25mL; g/25mL N 20181231 71596-027_c7d6c544-9d62-4d9c-a0a8-96237d4d64a3 71596-027 HUMAN OTC DRUG BOTANIC HEAL boH Derma Defense All In One Essence NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd NIACINAMIDE; ADENOSINE 2.6; .05 g/130mL; g/130mL N 20181231 71596-028_a23fc9e4-ab49-4861-b933-537a3131b459 71596-028 HUMAN OTC DRUG BOTANIC HEAL boH Derma Defense Wave Cushion 01 Natural Ivory Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Cj Olivenetworks Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.41; .67; .4 g/10g; g/10g; g/10g N 20181231 71596-029_9a895821-7858-43df-9b79-7f001c8cbbd8 71596-029 HUMAN OTC DRUG BOTANIC HEAL boH Derma Defense Wave Cushion 02 Natural Beige Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Cj Olivenetworks Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.41; .67; .4 g/10g; g/10g; g/10g N 20181231 71596-030_66e1d66b-fed0-4176-a52b-c3c3e11386a6 71596-030 HUMAN OTC DRUG BOTANIC HEAL boH Derma Water Ceramide Ampoule Cushion 01 Natural Ivory Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Cj Olivenetworks Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.22; .67; .4 g/10g; g/10g; g/10g N 20181231 71596-031_c58ef534-503f-4112-b0e4-1afc49d9b3c9 71596-031 HUMAN OTC DRUG BOTANIC HEAL boH Derma Water Ceramide Ampoule Cushion 02 Natural Beige Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Cj Olivenetworks Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.34; .73; .44 g/11g; g/11g; g/11g N 20181231 71596-032_bba1bd41-185e-47a2-a354-ae7cd1c99d8f 71596-032 HUMAN OTC DRUG BOTANIC HEAL boH Derma Water Ceramide ADENOSINE EMULSION TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd ADENOSINE .06 g/150mL N 20181231 71596-033_f0b75334-2b6f-4abe-881e-883119e25339 71596-033 HUMAN OTC DRUG BOTANIC HEAL boH Derma Water Ceramide Ge l ADENOSINE CREAM TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd ADENOSINE .03 g/95g N 20181231 71596-034_3afa188f-ba5d-470a-8979-ce94bbed51c3 71596-034 HUMAN OTC DRUG BOTANIC HEAL boH Derma Water Ceramide Toner ADENOSINE LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd ADENOSINE .06 g/150mL N 20181231 71596-035_937fc5dc-37a1-4957-ae4f-d3c9297230d4 71596-035 HUMAN OTC DRUG BOTANIC HEAL boH Derma Intensive Energy Essence NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71596-036_887bb424-34ce-4fdc-9827-24283d43dd59 71596-036 HUMAN OTC DRUG BOTANIC HEAL boH Derma Intensive Panthenol NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 71596-037_093667e6-f0ea-4eac-b739-ac1c50928381 71596-037 HUMAN OTC DRUG BOTANIC HEAL boH Acne Sensitive Fo am Cleanser SALICYLIC ACID GEL TOPICAL 20170701 OTC MONOGRAPH FINAL part333D Cj Olivenetworks Co., Ltd SALICYLIC ACID 1.25 g/250mL N 20181231 71596-038_d14c940e-6e52-45a4-8b98-7fe1ebe8227a 71596-038 HUMAN OTC DRUG BOTANIC HEAL boH Smart Tone Up Sun Octinoxate, Titanium Dioxide, Avobenzone, Octisalate, Octocrylene CREAM TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Cj Olivenetworks Co., Ltd OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 2.25; 1.71; .75; .6; .6 g/30mL; g/30mL; g/30mL; g/30mL; g/30mL N 20181231 71596-039_355ceb93-5ac2-42a1-9fce-ff591fcf973e 71596-039 HUMAN OTC DRUG BOTANIC HEAL boH Air Jet Daily Mask Madecassoside GLYCERIN PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd GLYCERIN .5 g/25mL N 20181231 71596-040_63260d28-de4b-4d43-bd15-62dad5cea3d9 71596-040 HUMAN OTC DRUG BOTANIC HEAL boH Air Jet Daily Mask Collagen ADENOSINE PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd ADENOSINE .01 g/25mL N 20181231 71596-041_5fcdb392-7dfc-40d3-bfe6-0fb947b80581 71596-041 HUMAN OTC DRUG BOTANIC HEAL boH Air Jet Daily Mask Panthenol ADENOSINE PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd NIACINAMIDE; ADENOSINE .5; .01 g/25mL; g/25mL N 20181231 71596-042_5649dd12-cbc9-49ac-9059-44b039fdee16 71596-042 HUMAN OTC DRUG BOTANIC HEAL boH Air Jet Daily Mask Hyaluronic Acid GLYCERIN PATCH TOPICAL 20170701 UNAPPROVED DRUG OTHER Cj Olivenetworks Co., Ltd GLYCERIN .5 g/25mL N 20181231 71596-043_b5d79e7b-39b1-411d-9270-3c51e5782442 71596-043 HUMAN OTC DRUG BOTANIC HEAL boH Dual Primer Sun No 1 OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE STICK TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Cj Olivenetworks Co., Ltd OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .99; .77; .49; .32 g/11g; g/11g; g/11g; g/11g N 20181231 71596-044_df6a46cc-b3ec-4228-979e-16f00d1ed1ee 71596-044 HUMAN OTC DRUG BOTANIC HEAL boH Dual Primer Sun No 2 OCTOCRYLENE, OCTINOXATE, OCTISALATE STICK TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 Cj Olivenetworks Co., Ltd OCTOCRYLENE; OCTINOXATE; OCTISALATE .99; .77; .49 g/11g; g/11g; g/11g N 20181231 71597-010_6182ae0a-2afa-46ad-bca4-b01f0a84b0ca 71597-010 HUMAN OTC DRUG ACWELL SENSITIVE SOLU TION SUN CONTROL Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 BNHCOSMETICS CO.,LTD. ZINC OXIDE; TITANIUM DIOXIDE 6.96; 3.99 g/50mL; g/50mL N 20181231 71597-020_5cb39d46-7d79-4acc-aab2-d78c17718b3e 71597-020 HUMAN OTC DRUG ACWELL DAILY SUN CONTROL Octinoxate, Titanium Dioxide, Avobenzone, Octisalate, Octocrylene EMULSION TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 BNHCOSMETICS CO.,LTD. OCTINOXATE; TITANIUM DIOXIDE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 3.75; 2.12; 1.25; 1; 1 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL N 20181231 71597-030_f9b55d7e-5770-48eb-bf2b-fae20e5fe07d 71597-030 HUMAN OTC DRUG ACWELL AQUA CAP SULE SUN CONTROL Octinoxate, Octisalate, Avobenzone GEL TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 BNHCOSMETICS CO.,LTD. OCTINOXATE; AVOBENZONE; OCTISALATE 3.5; 1.5; 2.25 g/50mL; g/50mL; g/50mL N 20181231 71600-001_55aa322c-8357-2586-e054-00144ff8d46c 71600-001 HUMAN OTC DRUG PUREFORET Skin balancing glycerin LOTION TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 ECOCATION Co., Ltd. GLYCERIN 4 g/100mL N 20181231 71600-002_55aa2ed4-8df8-30e8-e054-00144ff8d46c 71600-002 HUMAN OTC DRUG PUREFORET Skin Balancing glycerin CREAM TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 ECOCATION Co., Ltd. GLYCERIN 1 g/100mL N 20181231 71600-003_55aadf54-1843-3fea-e054-00144ff8d46c 71600-003 HUMAN OTC DRUG PUREFORET Hydrating Toner glycerin LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 ECOCATION Co., Ltd. GLYCERIN 2 g/100mL N 20181231 71600-004_55ab03c7-3f3f-175b-e054-00144ff88e88 71600-004 HUMAN OTC DRUG PUREFORET Hydrating glycerin LOTION TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 ECOCATION Co., Ltd. GLYCERIN 4 g/100mL N 20181231 71600-005_55ab359b-d09c-5412-e054-00144ff8d46c 71600-005 HUMAN OTC DRUG PUREFORET Hydrating glycerin CREAM TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 ECOCATION Co., Ltd. GLYCERIN 1 g/100mL N 20181231 71600-006_55ab68d0-c469-2f41-e054-00144ff88e88 71600-006 HUMAN OTC DRUG PUREFORET Brightening Toner glycerin LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 ECOCATION Co., Ltd. GLYCERIN 4 g/100mL N 20181231 71600-007_55ab68d0-c496-2f41-e054-00144ff88e88 71600-007 HUMAN OTC DRUG PUREFORET BRIGHTENING glycerin LOTION TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 ECOCATION Co., Ltd. GLYCERIN 4 g/100mL N 20181231 71600-008_55ab68d0-c4a9-2f41-e054-00144ff88e88 71600-008 HUMAN OTC DRUG PUREFORET Brightening glycerin CREAM TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 ECOCATION Co., Ltd. GLYCERIN 1 g/100mL N 20181231 71600-009_55abc1a9-7151-6dae-e054-00144ff8d46c 71600-009 HUMAN OTC DRUG PUREFORET Soothing Toner glycerin LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 ECOCATION Co., Ltd. GLYCERIN 2 g/100mL N 20181231 71600-010_555c35f1-f400-54a3-e054-00144ff8d46c 71600-010 HUMAN OTC DRUG PUREFORET Skin balancing Toner allantoin LIQUID TOPICAL 20170728 UNAPPROVED DRUG OTHER ECOCATION Co., Ltd. ALLANTOIN .2 g/100mL N 20181231 71600-011_55abc1a9-7157-6dae-e054-00144ff8d46c 71600-011 HUMAN OTC DRUG PUREFORET SOOTHING glycerin LOTION TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 ECOCATION Co., Ltd. GLYCERIN 4 g/100mL N 20181231 71600-012_55abc1a9-7168-6dae-e054-00144ff8d46c 71600-012 HUMAN OTC DRUG PUREFORET Soothing glycerin CREAM TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 ECOCATION Co., Ltd. GLYCERIN 1 g/100mL N 20181231 71603-1700_544b9ca2-f66f-526a-e054-00144ff88e88 71603-1700 HUMAN OTC DRUG CleanAFNaturalAnticavityToothpaste sodium fluroide paste, dentrifice PASTE DENTAL 20170717 OTC MONOGRAPH FINAL part355 CLEANAF GLOBAL LIMITED LIABILITY COMPANY SODIUM FLUORIDE .22 g/100g N 20181231 71605-000_48e7b70c-97f4-410d-a299-36ca109a9d71 71605-000 HUMAN OTC DRUG HairSanity Step 1 HYDROCORTISONE ACETATE SHAMPOO TOPICAL 20170810 OTC MONOGRAPH NOT FINAL part348 H Plus Holdings HYDROCORTISONE ACETATE 5 mg/mL N 20181231 71605-100_5a5c56d0-8fa3-4ed1-acc0-eab94e88c91e 71605-100 HUMAN OTC DRUG HairSanity Step 2 Salicylic Acid LOTION/SHAMPOO TOPICAL 20170810 OTC MONOGRAPH FINAL part358H H Plus Holdings SALICYLIC ACID 18.5 mg/mL N 20181231 71607-100_2cc9e321-5158-419f-83e2-75f1bde53440 71607-100 HUMAN OTC DRUG SYMBA Skin Lightening Hydroquinone CREAM TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part358A Craig Doura LLC HYDROQUINONE 19 mg/g N 20181231 71607-200_14c1edd5-03b9-423e-a184-179f2eba3523 71607-200 HUMAN OTC DRUG SYMBA Skin Lightening Hydroquinone CREAM TOPICAL 20171012 OTC MONOGRAPH NOT FINAL part358A Craig Doura LLC HYDROQUINONE 19 mg/g N 20181231 71607-300_0855ea57-fd18-44a0-94e6-3b7df3f7401f 71607-300 HUMAN OTC DRUG SYMBA Skin Lightening HYDROQUINONE CREAM TOPICAL 20171221 OTC MONOGRAPH NOT FINAL part358A Craig Doura LLC HYDROQUINONE 19 mg/g N 20181231 71608-0001_61c3305e-a45a-1ad9-e053-2a91aa0a6b63 71608-0001 HUMAN OTC DRUG Rurina Sulfate, Potassium Ion, Chloride Ion LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER NANO BIO TECH CO.,Ltd SULFATE ION; POTASSIUM CATION; CHLORIDE ION 3.6; .25; .11 g/L; g/L; g/L N 20191231 71609-0001_56207c92-1b29-4350-e054-00144ff8d46c 71609-0001 HUMAN OTC DRUG MOISTIE TOK PLUS Niacinamide, Adenosine CREAM TOPICAL 20170601 UNAPPROVED DRUG OTHER Purecell Korea Co., Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71609-0002_5622229a-fe67-4ef8-e054-00144ff88e88 71609-0002 HUMAN OTC DRUG MOISTIE FILL PLUS Niacinamide, Adenosine CREAM TOPICAL 20170601 UNAPPROVED DRUG OTHER Purecell Korea Co., Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71609-0003_563605cb-a2ca-5408-e054-00144ff88e88 71609-0003 HUMAN OTC DRUG MOISTIE CELL PLUS Niacinamide, Adenosine CREAM TOPICAL 20170601 UNAPPROVED DRUG OTHER Purecell Korea Co., Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71609-0004_562312c8-ce74-5722-e054-00144ff88e88 71609-0004 HUMAN OTC DRUG MOISTIE PURE ESSENCE Niacinamide LIQUID TOPICAL 20170601 UNAPPROVED DRUG OTHER Purecell Korea Co., Ltd. NIACINAMIDE 2 g/100mL N 20181231 71609-0005_562312c8-ce88-5722-e054-00144ff88e88 71609-0005 HUMAN OTC DRUG QUEEN PURECELL WHITENING 3-STEP MASK NIACINAMIDE, ADENOSINE KIT 20170601 UNAPPROVED DRUG OTHER Purecell Korea Co., Ltd. N 20181231 71609-0009_56375b26-8b45-74c8-e054-00144ff88e88 71609-0009 HUMAN OTC DRUG PREMIUM ULTRA UV PURE SUN Octocrylene, Ethylhexyl Methoxycinnamate, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Ethylhexyl Salicylate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine STICK TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part352 Purecell Korea Co., Ltd. OCTINOXATE; DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE; OCTISALATE; BEMOTRIZINOL; OCTOCRYLENE 7; 7; 5; 2; 8 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 71610-001_47c4bc9b-3508-4d2f-9119-2419b59c5b59 71610-001 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20170302 ANDA ANDA065211 Aphena Pharma Solutions - Tennessee, LLC AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 71610-002_e4f274aa-87d9-48e3-bc4b-1dda996a8b60 71610-002 HUMAN PRESCRIPTION DRUG Tolterodine Tartrate Tolterodine Tartrate CAPSULE, EXTENDED RELEASE ORAL 20160721 ANDA ANDA201486 Aphena Pharma Solutions - Tennessee, LLC TOLTERODINE TARTRATE 2 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 71610-003_6573bf6d-6f0f-44e5-b8db-18717f3c16d7 71610-003 HUMAN PRESCRIPTION DRUG Pantoprazole Sodium Pantoprazole Sodium TABLET, DELAYED RELEASE ORAL 20150501 ANDA ANDA202038 Aphena Pharma Solutions - Tennessee, LLC PANTOPRAZOLE SODIUM 40 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA] N 20181231 71610-004_0c60ebf6-62a7-4b19-ae8f-60fa3e3a06e6 71610-004 HUMAN PRESCRIPTION DRUG TEMAZEPAM temazepam CAPSULE ORAL 20100223 NDA NDA018163 Aphena Pharma Solutions - Tennessee, LLC TEMAZEPAM 7.5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 71610-005_f9d0e5b7-7ea4-42cf-979a-74c174def047 71610-005 HUMAN PRESCRIPTION DRUG Primidone primidone TABLET ORAL 20050224 ANDA ANDA040586 Aphena Pharma Solutions - Tennessee, LLC PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 71610-006_b956bad0-6e9d-41a2-8a21-a9c7697564ec 71610-006 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET, FILM COATED ORAL 20170824 ANDA ANDA075977 Aphena Pharma Solutions - Tennessee, LLC TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 71610-008_a952aee3-c9bb-44b8-b7fa-be75b4602794 71610-008 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 20091009 ANDA ANDA078203 Aphena Pharma Solutions - Tennessee, LLC LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 71610-009_fbcee942-26fd-4f5d-b804-7aede580010c 71610-009 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20170309 ANDA ANDA076958 Aphena Pharma Solutions - Tennessee, LLC LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 71610-011_f384e3d8-d9fd-481c-b924-4bf98dfb5bdf 71610-011 HUMAN PRESCRIPTION DRUG memantine hydrochloride memantine hydrochloride TABLET ORAL 20150401 NDA NDA021487 Aphena Pharma Solutions - Tennessee, LLC MEMANTINE HYDROCHLORIDE 10 mg/1 NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC] N 20181231 71610-012_ff264398-65e4-413a-8240-3c7173fcf937 71610-012 HUMAN PRESCRIPTION DRUG Nifedipine Nifedipine TABLET, EXTENDED RELEASE ORAL 20001204 ANDA ANDA075269 Aphena Pharma Solutions - Tennessee, LLC NIFEDIPINE 60 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 71610-013_002501e0-f91c-48c2-b42c-4a32037d9de2 71610-013 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110602 NDA AUTHORIZED GENERIC NDA020699 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 150 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 71610-014_5f614438-c196-4ccd-8764-b358a5a1bbf4 71610-014 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20170608 ANDA ANDA083177 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 71610-015_5f614438-c196-4ccd-8764-b358a5a1bbf4 71610-015 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20170608 ANDA ANDA083177 Aphena Pharma Solutions - Tennessee, LLC HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 71610-016_4c65037d-c8be-43f5-bc39-60a2bd7a8a65 71610-016 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20140731 ANDA ANDA078048 Aphena Pharma Solutions - Tennessee, LLC CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 71610-017_73d70384-b8e1-4078-937f-fbc3d47dd4d6 71610-017 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20170925 NDA AUTHORIZED GENERIC NDA018333 Aphena Pharma Solutions - Tennessee, LLC SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] N 20181231 71610-018_002501e0-f91c-48c2-b42c-4a32037d9de2 71610-018 HUMAN PRESCRIPTION DRUG Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE ORAL 20110602 NDA AUTHORIZED GENERIC NDA020699 Aphena Pharma Solutions - Tennessee, LLC VENLAFAXINE HYDROCHLORIDE 75 mg/1 Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 71610-019_ed9d86db-9dd5-4e5e-bcb9-3a5d10ab8216 71610-019 HUMAN PRESCRIPTION DRUG LANOXIN digoxin TABLET ORAL 20120930 NDA NDA020405 Aphena Pharma Solutions - Tennessee, LLC DIGOXIN .125 mg/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] N 20181231 71610-020_16602e29-1aa5-4422-9e3c-213e4adc2c47 71610-020 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, EXTENDED RELEASE ORAL 20091202 ANDA ANDA078596 Aphena Pharma Solutions - Tennessee, LLC METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 71610-021_6d839289-f4c6-44d7-a6f5-a4c178766fb2 71610-021 HUMAN PRESCRIPTION DRUG Chlorthalidone Chlorthalidone TABLET ORAL 20160212 ANDA ANDA089286 Aphena Pharma Solutions - Tennessee, LLC CHLORTHALIDONE 50 mg/1 Increased Diuresis [PE],Thiazide-like Diuretic [EPC] N 20181231 71610-022_5f117176-0905-45c0-800d-0b2463605a8d 71610-022 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20120529 ANDA ANDA090548 Aphena Pharma Solutions - Tennessee, LLC ATORVASTATIN CALCIUM 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20191231 71610-023_3a3a025d-218c-4bf5-91f2-ca7078dc218e 71610-023 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20131018 ANDA ANDA074869 Aphena Pharma Solutions - Tennessee, LLC CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 71610-024_48981023-2380-4c2e-9250-d7693ce3242a 71610-024 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20170814 ANDA ANDA076001 Aphena Pharma Solutions - Tennessee, LLC FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20191231 71610-026_604d0a85-7588-4626-892d-666975658f33 71610-026 HUMAN PRESCRIPTION DRUG Montelukast Sodium Montelukast Sodium TABLET, FILM COATED ORAL 20120803 ANDA ANDA202096 Aphena Pharma Solutions - Tennessee, LLC MONTELUKAST SODIUM 10 mg/1 Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] N 20191231 71610-027_84b62471-43ba-4761-92cf-17865209c8e2 71610-027 HUMAN PRESCRIPTION DRUG fenofibrate fenofibrate TABLET ORAL 20140813 ANDA ANDA090715 Aphena Pharma Solutions - Tennessee, LLC FENOFIBRATE 145 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC] N 20191231 71611-001_575e1d73-5ba0-69b6-e053-2991aa0a469f 71611-001 HUMAN OTC DRUG Wish Care Petrolatum CREAM TOPICAL 20170721 OTC MONOGRAPH FINAL part347 Click Products LLC PETROLATUM 99.7 g/100g N 20181231 71611-004_5799925b-aca6-a901-e053-2991aa0a6480 71611-004 HUMAN OTC DRUG Wish Care Original Petrolatum CREAM TOPICAL 20170721 OTC MONOGRAPH FINAL part347 Click Products LLC PETROLATUM 99.7 g/100g N 20181231 71611-005_579b8d96-db15-64d8-e053-2a91aa0a6fd8 71611-005 HUMAN OTC DRUG Wish Care COCOA BUTTER Petrolatum CREAM TOPICAL 20170721 OTC MONOGRAPH FINAL part347 Click Products LLC PETROLATUM 99.7 g/100g N 20181231 71611-006_579c72d4-30b1-505d-e053-2a91aa0a6245 71611-006 HUMAN OTC DRUG Wish Care BABY Petrolatum CREAM TOPICAL 20170721 OTC MONOGRAPH FINAL part347 Click Products LLC PETROLATUM 99.7 g/100g N 20181231 71611-007_579cefbc-fac6-82b8-e053-2a91aa0a5a3b 71611-007 HUMAN OTC DRUG Wish Care Aloe Petrolatum CREAM TOPICAL 20170721 OTC MONOGRAPH FINAL part347 Click Products LLC PETROLATUM 99.7 g/100g N 20181231 71611-008_579d8e2f-70a6-4970-e053-2a91aa0a635d 71611-008 HUMAN OTC DRUG Wish Care Lavender Petrolatum CREAM TOPICAL 20170721 OTC MONOGRAPH FINAL part347 Click Products LLC PETROLATUM 99.7 g/100g N 20181231 71611-009_5b4a7dba-6747-bcb4-e053-2a91aa0a1f1a 71611-009 HUMAN OTC DRUG Epsom Salt Wish care MAGNESIUM SULFATE, UNSPECIFIED GRANULE ORAL; TOPICAL 20171009 OTC MONOGRAPH NOT FINAL part334 Click Products LLC MAGNESIUM SULFATE, UNSPECIFIED 100 g/100g N 20181231 71611-010_5beb2c85-4ffa-b5c0-e053-2991aa0a367b 71611-010 HUMAN OTC DRUG Epsom Salt Baby Beauty MAGNESIUM SULFATE, UNSPECIFIED GRANULE ORAL; TOPICAL 20171019 OTC MONOGRAPH NOT FINAL part334 Click Products LLC MAGNESIUM SULFATE, UNSPECIFIED 100 g/100g N 20181231 71611-011_5bebea3f-895d-41d5-e053-2991aa0a81c7 71611-011 HUMAN OTC DRUG Advanced Hand Sanitizer Vitamin E Ethyl Alcohol GEL TOPICAL 20171018 OTC MONOGRAPH NOT FINAL part333E Click Products LLC ALCOHOL 62 g/53mL N 20181231 71611-012_5bec2454-627d-c772-e053-2a91aa0a5f12 71611-012 HUMAN OTC DRUG Advanced Hand Sanitizer Natural Aloe Ethyl Alcohol GEL TOPICAL 20171018 OTC MONOGRAPH NOT FINAL part333E Click Products LLC ALCOHOL 62 g/53mL N 20181231 71611-013_5bec9e6f-9e63-6144-e053-2a91aa0a0bab 71611-013 HUMAN OTC DRUG Advanced Hand Sanitizer Lavender Ethyl Alcohol GEL TOPICAL 20171018 OTC MONOGRAPH NOT FINAL part333E Click Products LLC ALCOHOL 62 g/53mL N 20181231 71611-014_5beba486-b8b5-6969-e053-2991aa0aa5b1 71611-014 HUMAN OTC DRUG Advanced Hand Sanitizer Berries Ethyl Alcohol GEL TOPICAL 20171019 OTC MONOGRAPH NOT FINAL part333E Click Products LLC ALCOHOL 62 g/53mL N 20181231 71611-015_63af0769-6980-15b2-e053-2991aa0a6f62 71611-015 HUMAN OTC DRUG Wish Care Menthol, Camphor, Eucalyptus Oil CREAM TOPICAL 20180126 OTC MONOGRAPH FINAL part341 Click Products LLC CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 2.6; 1.2 g/100g; g/100g; g/100g N 20191231 71611-016_63b20a8c-c521-1949-e053-2a91aa0a4ca4 71611-016 HUMAN OTC DRUG Wish Care Menthol, Camphor CREAM TOPICAL 20180126 OTC MONOGRAPH FINAL part341 Click Products LLC CAMPHOR (NATURAL); MENTHOL .5; 1 g/100g; g/100g N 20191231 71613-001_7239c6fd-f68a-4f74-ad7c-368f90e3cb4f 71613-001 HUMAN OTC DRUG Cleansing Wipes Salicylic Acid SWAB TOPICAL 20170728 OTC MONOGRAPH FINAL part333D Nextcell Medical SALICYLIC ACID 2 g/100mL N 20181231 71614-001_5554a894-065e-7070-e054-00144ff88e88 71614-001 HUMAN OTC DRUG Macoma Senior Premium Cleanser ALLANTOIN GEL TOPICAL 20170725 OTC MONOGRAPH FINAL part347 PARMA KOREA.CO.LTD ALLANTOIN 10 mg/mL N 20181231 71614-002_5554a894-0668-7070-e054-00144ff88e88 71614-002 HUMAN OTC DRUG Parma Anus Skin Premium Cleanser ALLANTOIN GEL TOPICAL 20170725 UNAPPROVED DRUG OTHER PARMA KOREA.CO.LTD ALLANTOIN 3 mg/mL N 20181231 71617-100_2f67ca70-c46e-4974-ae0a-70280d68d6f4 71617-100 HUMAN OTC DRUG CLEARSYNERGY SALICYLIC ACID LIQUID TOPICAL 20170907 OTC MONOGRAPH FINAL part333D SRL ENTERPRISES LLC SALICYLIC ACID .25 g/50mL N 20181231 71619-010_46e66d7d-f634-4d30-bd83-4394e0efa9f9 71619-010 HUMAN OTC DRUG MIRACLETOX Time Rewind Advanced Lifting Ampoule NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .24; .004 g/12mL; g/12mL N 20181231 71619-020_37230f21-f268-433c-a5a4-8b15df7dc6ee 71619-020 HUMAN OTC DRUG MIRACLETOX Time Rewind Advanced Mask NIACINAMIDE, ADENOSINE PATCH TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .6; .012 g/30g; g/30g N 20181231 71619-030_c975c750-5753-4e57-85ac-8f7ea9a0b9d6 71619-030 HUMAN OTC DRUG MIRACLETOX Time Rewind Advanced Meso Tox NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .04; .0008 g/2g; g/2g N 20181231 71619-040_40a6b944-5e63-4971-8ee9-d81595a7007c 71619-040 HUMAN OTC DRUG MIRACLETOX Time Rewind Advanced Essential Toner NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .3; .006 g/15mL; g/15mL N 20181231 71619-050_059a1a59-e120-4cd3-9a73-1a38fb3b19d1 71619-050 HUMAN OTC DRUG MIRACLETOX Time Rewind Advanced TOX Ampoule NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .04; .0008 g/2g; g/2g N 20181231 71619-060_d249b0d7-90d0-4433-9761-65278a774033 71619-060 HUMAN OTC DRUG MIRACLETOX Time Rewind Advanced Facial Cleanser Witch Hazel LIQUID TOPICAL 20170801 OTC MONOGRAPH FINAL part347 Beauren Korea Inc. WITCH HAZEL .01 g/15mL N 20181231 71619-070_1e7fe656-59ed-448f-8b67-fb8e95f6a114 71619-070 HUMAN OTC DRUG MIRACLETOX Time Rewind Advanced Feel NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE 1; .02 g/50g; g/50g N 20181231 71619-080_5c23cdc7-9e06-4c98-9070-fced50d9bbff 71619-080 HUMAN OTC DRUG MIRACLETOX Time Rewind Advanced Feel NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .3; .006 g/15g; g/15g N 20181231 71619-090_4635c7c1-beba-4080-8fbe-a8464d6403b6 71619-090 HUMAN OTC DRUG CELLSTORY Plus Cell Cleanser GLYCERIN LIQUID TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. GLYCERIN .05 g/mL N 20181231 71619-100_87f7b66f-be7a-4fa4-ae04-38c537a6fb44 71619-100 HUMAN OTC DRUG CELLSTORY Plus Cell Fluid NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .02; .0004 g/mL; 1/mL N 20181231 71619-110_21923d0c-d8c8-47cd-8392-d2e578cdc382 71619-110 HUMAN OTC DRUG CELLSTORY Plus Cell Awake Essence NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .02; .0004 g/mL; 1/mL N 20181231 71619-120_4af9f218-c037-4851-98df-4305df37ec7e 71619-120 HUMAN OTC DRUG CELLSTORY Plus Cell Activator Ampoule NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .04; .0008 g/2mL; 1/2mL N 20181231 71619-130_db9b357e-2174-4ffd-81fa-63e6ad0d575b 71619-130 HUMAN OTC DRUG CELLSTORY Plus Cellplant Meso Care NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .03; .0006 g/1.5g; 1/1.5g N 20181231 71619-140_5657f210-5a97-4702-98ee-eba0c3598017 71619-140 HUMAN OTC DRUG CELLSTORY Plus Cell Ultra NIACINAMIDE, ADENOSINE GEL TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .08; .0016 g/4g; 1/4g N 20181231 71619-160_3ec1dc91-8460-43b9-b405-9d4fd325c7c0 71619-160 HUMAN OTC DRUG CELLSTORY Plus Cell Recovery NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .02; .0004 g/g; g/g N 20181231 71619-170_0dd2193d-d6d9-47d5-b6f0-836d386075f0 71619-170 HUMAN OTC DRUG CELLSTORY Plus Cell Calming Mask NIACINAMIDE, ADENOSINE PATCH TOPICAL 20170801 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .6; .012 g/30g; g/30g N 20181231 71619-180_f7bc14de-baa4-49ca-ac2c-4c6d1f554d5a 71619-180 HUMAN OTC DRUG MIRACLETOX Time Rewind Advanced Lifting Ampoule 40mL NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20171101 UNAPPROVED DRUG OTHER Beauren Korea Inc. NIACINAMIDE; ADENOSINE .8; .016 g/40mL; g/40mL N 20181231 71621-0002_55bbd324-c1d7-4e64-e054-00144ff88e88 71621-0002 HUMAN OTC DRUG Black Food Recipe MGgel Mask GLYCERIN LIQUID TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part347 C&TECH CORPORATION GLYCERIN 8.13 g/100g N 20181231 71621-0003_55bbd324-c1fa-4e64-e054-00144ff88e88 71621-0003 HUMAN OTC DRUG Purederm Black Food MGgel Eye Zone Mask GLYCERIN LIQUID TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part347 C&TECH CORPORATION GLYCERIN 8.13 g/100g N 20181231 71621-0004_55be3be7-e07e-1147-e054-00144ff8d46c 71621-0004 HUMAN OTC DRUG Black Food MGgel Lip Zone Mask GLYCERIN LIQUID TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part347 C&TECH CORPORATION GLYCERIN 8.13 g/100g N 20181231 71621-0005_55be44bf-52e4-3797-e054-00144ff88e88 71621-0005 HUMAN OTC DRUG Black Food MGgel Under Eye Mask GLYCERIN LIQUID TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part347 C&TECH CORPORATION GLYCERIN 8.13 g/100g N 20181231 71621-0006_55be44bf-52f1-3797-e054-00144ff88e88 71621-0006 HUMAN OTC DRUG Magic Glow Pure Gel Mask GLYCERIN LIQUID TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part347 C&TECH CORPORATION GLYCERIN 8.7675 g/100g N 20181231 71621-0007_55d2f2c7-78a8-5b08-e054-00144ff88e88 71621-0007 HUMAN OTC DRUG NMF Water Barrier MGgel Mask GLYCERIN LIQUID TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part347 C&TECH CORPORATION GLYCERIN 8.75 g/100g N 20181231 71621-0008_55c0409c-8705-238d-e054-00144ff88e88 71621-0008 HUMAN OTC DRUG VITA10 Brightening CapsuleMask Glycerin KIT TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part347 C&TECH CORPORATION N 20181231 71622-001_616d73b6-86fb-af5f-e053-2991aa0ad70f 71622-001 HUMAN OTC DRUG Antiseptic BENZALKONIUM CHLORIDE SWAB TOPICAL 20170725 OTC MONOGRAPH NOT FINAL part333A MCL Enterprises BENZALKONIUM CHLORIDE 1.3 mg/g N 20181231 71622-002_616d30d0-feec-22db-e053-2991aa0aa5b1 71622-002 HUMAN OTC DRUG Sting Relief BENZOCAINE, ISOPROPYL ALCOHOL PATCH TOPICAL 20170725 OTC MONOGRAPH NOT FINAL part333A MCL Enterprises BENZOCAINE; ISOPROPYL ALCOHOL 60; 600 mg/g; mg/g N 20181231 71622-003_616db97b-6da1-21c0-e053-2991aa0ab688 71622-003 HUMAN OTC DRUG Povidone Iodine Prep POVIDONE-IODINE PATCH TOPICAL 20170725 OTC MONOGRAPH NOT FINAL part333E MCL Enterprises POVIDONE-IODINE 100 mg/g N 20181231 71622-004_554c065f-e145-5b9c-e054-00144ff8d46c 71622-004 HUMAN OTC DRUG Alcohol ISOPROPYL ALCOHOL PATCH TOPICAL 20170725 OTC MONOGRAPH NOT FINAL part333A MCL Enterprises ISOPROPYL ALCOHOL 700 mg/g N 20181231 71623-100_553dd6db-30c2-3520-e054-00144ff88e88 71623-100 HUMAN OTC DRUG Natural Friend White Day Soft Cream Niacinamide, Dimethicone CREAM TOPICAL 20170726 UNAPPROVED DRUG OTHER Asia Nano Teck Corporation NIACINAMIDE; DIMETHICONE 1; .52 g/50g; g/50g N 20181231 71624-100_eca27d6d-39b7-4088-a969-e5696058f5e9 71624-100 HUMAN OTC DRUG Ugly Duck Miracle Multi Shield Sun Gel Octinoxate, Octisalate, Titanium Dioxide, GEL TOPICAL 20170726 OTC MONOGRAPH NOT FINAL part352 EREPH CO., LTD OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 4.2; 1.8; .8964 g/60mL; g/60mL; g/60mL N 20181231 71627-116_f973b43e-461f-4362-970e-dbc26c973e68 71627-116 HUMAN OTC DRUG Sunscreen with Aloe Vera SPF 30 Octinoxate, Octisalate, and Oxybenzone LOTION TOPICAL 20171002 OTC MONOGRAPH FINAL part352 Fore Supply, Inc OCTINOXATE; OCTISALATE; OXYBENZONE 75; 50; 60 mg/mL; mg/mL; mg/mL N 20181231 71627-128_513f5a66-9688-461d-b4be-849f9e429c85 71627-128 HUMAN OTC DRUG Antiseptic Blue Mint Mouthwash Methyl Salicylate, MENTHOL, UNSPECIFIED FORM, Eucalyptol, and Thymol LIQUID ORAL 20170605 OTC MONOGRAPH NOT FINAL part356 Fore Supply, Inc METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; EUCALYPTOL; THYMOL .6; .42; .92; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71630-132_5e345fde-35d8-d3d2-e053-2a91aa0ac227 71630-132 HUMAN OTC DRUG On Guard Sanitizing Mist Alcohol SPRAY TOPICAL 20171117 OTC MONOGRAPH NOT FINAL part333A doTERRA International, LLC ALCOHOL 70 mL/100mL N 20181231 71630-395_55ef3bca-ccaa-22b7-e054-00144ff88e88 71630-395 HUMAN OTC DRUG On Guard Sanitizing Mist Alcohol SPRAY TOPICAL 20170911 OTC MONOGRAPH NOT FINAL part333A doTERRA International, LLC ALCOHOL 64 mL/100mL N 20181231 71631-0001_564c402d-cce8-232f-e054-00144ff8d46c 71631-0001 HUMAN OTC DRUG 37.4 WATER LIQUID ORAL 20170809 UNAPPROVED DRUG OTHER Jesus Glory Bio Co.,Ltd. WATER 99.9974 g/100mL N 20181231 71631-0002_56b06c65-d5df-43af-e054-00144ff8d46c 71631-0002 HUMAN OTC DRUG 37.4 WATER LIQUID ORAL 20170809 UNAPPROVED DRUG OTHER Jesus Glory Bio Co.,Ltd. WATER 99.9974 g/100L N 20181231 71635-010_eadebf85-029f-4945-bca6-592717e127b5 71635-010 HUMAN OTC DRUG MULBIT Firming Mask Pack Niacinamide, Adenosine PATCH TOPICAL 20171001 UNAPPROVED DRUG OTHER First Cosmetic Co., Ltd NIACINAMIDE; ADENOSINE .02; .002 g/23g; g/23g N 20181231 71635-020_95497bea-3986-420b-a488-08776f3992e9 71635-020 HUMAN OTC DRUG MULBIT Aqua Mask Pack Niacinamide, Adenosine PATCH TOPICAL 20171001 UNAPPROVED DRUG OTHER First Cosmetic Co., Ltd NIACINAMIDE; ADENOSINE .02; .002 g/23g; g/23g N 20181231 71635-030_8a45562c-53e0-4499-aff1-5135d5b5f115 71635-030 HUMAN OTC DRUG MULBIT Collagen Mask Pack Niacinamide, Adenosine PATCH TOPICAL 20171001 UNAPPROVED DRUG OTHER First Cosmetic Co., Ltd NIACINAMIDE; ADENOSINE .02; .002 g/23g; g/23g N 20181231 71635-040_4f2e89ce-b658-4bfd-b51d-81bb85e70d78 71635-040 HUMAN OTC DRUG MULBIT Donkey Milk Moisturizing Niacinamide, Adenosine CREAM TOPICAL 20171001 UNAPPROVED DRUG OTHER First Cosmetic Co., Ltd NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 71635-050_fe98a261-12e1-44f1-969d-f7a5dc81d282 71635-050 HUMAN OTC DRUG MULBIT Donkey Milk Mask Niacinamide, Adenosine PATCH TOPICAL 20171001 UNAPPROVED DRUG OTHER First Cosmetic Co., Ltd NIACINAMIDE; ADENOSINE .54; .01 g/27g; g/27g N 20181231 71635-060_81966fbb-b55a-4d03-8c94-dcd3f902ba32 71635-060 HUMAN OTC DRUG Man Power Pack Glycerin PATCH TOPICAL 20171001 UNAPPROVED DRUG OTHER First Cosmetic Co., Ltd GLYCERIN .34 g/17g N 20181231 71635-080_8a5d32fb-1d71-4336-8d5a-811019fff6a8 71635-080 HUMAN OTC DRUG MULBIT Hydro Special Ample Niacinamide, Adenosine LIQUID TOPICAL 20171001 UNAPPROVED DRUG OTHER First Cosmetic Co., Ltd NIACINAMIDE; ADENOSINE .54; .01 g/27mL; g/27mL N 20181231 71635-090_c80886da-e72a-4714-86f3-5d7c5759d363 71635-090 HUMAN OTC DRUG MULBIT MEDIST Niacinamide, Adenosine LIQUID TOPICAL 20171001 UNAPPROVED DRUG OTHER First Cosmetic Co., Ltd NIACINAMIDE; ADENOSINE .08; .008 g/81g; g/81g N 20181231 71635-100_f6de3f6f-68d0-41c8-9181-496433e26048 71635-100 HUMAN OTC DRUG MULBIT ME FIRMING SLEEPING PACK Niacinamide, Adenosine CREAM TOPICAL 20171001 UNAPPROVED DRUG OTHER First Cosmetic Co., Ltd NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 71636-841_55dd314c-b9fa-255e-e054-00144ff88e88 71636-841 HUMAN OTC DRUG SkinProtect SPF 50 SHEER ROLLER SUNSCREEN HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE LOTION TOPICAL 20170803 OTC MONOGRAPH NOT FINAL part352 Mitchell Group USA, LLC HOMOSALATE; OCTINOXATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 100; 75; 75; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71638-0001_58543c2d-9fec-2ba9-e053-2991aa0a96ab 71638-0001 HUMAN OTC DRUG Biotoc Regen Ampoule Adenosine LIQUID TOPICAL 20170904 UNAPPROVED DRUG OTHER Dermafirm INC. ADENOSINE .04 g/100mL N 20181231 71638-0002_58543c2d-a001-2ba9-e053-2991aa0a96ab 71638-0002 HUMAN OTC DRUG Biotoc Regen Serum Adenosine GEL TOPICAL 20170904 UNAPPROVED DRUG OTHER Dermafirm INC. ADENOSINE .04 g/100g N 20181231 71638-0004_58554a7e-90ce-f2da-e053-2991aa0af4dc 71638-0004 HUMAN OTC DRUG Biotoc Regen Peel Adenosine GEL TOPICAL 20170904 UNAPPROVED DRUG OTHER Dermafirm INC. ADENOSINE .04 g/100g N 20181231 71638-0005_585624bf-bb8e-33ae-e053-2a91aa0abc51 71638-0005 HUMAN OTC DRUG Pick Me Pad Make-up Remover Glycerin LIQUID TOPICAL 20170904 OTC MONOGRAPH NOT FINAL part347 Dermafirm INC. GLYCERIN 3.055 g/100g N 20181231 71638-0006_585624bf-bba3-33ae-e053-2a91aa0abc51 71638-0006 HUMAN OTC DRUG Pick Me Pad Azulene Moisture Glycerin LIQUID TOPICAL 20170904 OTC MONOGRAPH NOT FINAL part347 Dermafirm INC. GLYCERIN 2.145 g/100g N 20181231 71638-0007_585624bf-bba5-33ae-e053-2a91aa0abc51 71638-0007 HUMAN OTC DRUG Pick Me Pad Oil Control Glycerin LIQUID TOPICAL 20170904 OTC MONOGRAPH NOT FINAL part347 Dermafirm INC. GLYCERIN 3.005 g/100g N 20181231 71638-0008_58569429-5db3-3bcb-e053-2a91aa0abb87 71638-0008 HUMAN OTC DRUG Ultra Soothing Toner Allantoin LIQUID TOPICAL 20170904 OTC MONOGRAPH FINAL part347 Dermafirm INC. ALLANTOIN .5 g/100mL N 20181231 71638-0010_58574c76-fcae-1590-e053-2991aa0a2caa 71638-0010 HUMAN OTC DRUG Ultra Soothing Mask 1pc Glycerin LIQUID TOPICAL 20170904 OTC MONOGRAPH NOT FINAL part347 Dermafirm INC. GLYCERIN 1.005 g/100g N 20181231 71642-016_5d55e918-98ba-4989-e053-2a91aa0a9ad7 71642-016 HUMAN OTC DRUG SPF30 SUNSCREEN OCTISALATE, OCTISALATE, OXYBENZONE LOTION TOPICAL 20171106 OTC MONOGRAPH NOT FINAL part352 Shanghai Mengna Personal Care Co., Ltd OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 20; 40; 25 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71647-001_1af92f46-ef15-4b08-a75b-7206f752d1e4 71647-001 HUMAN PRESCRIPTION DRUG ROTOP - DMSA Kit for the Preparation of Technetium Tc99m Succimer Injection INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20170808 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE ROTOP Pharmaka GmbH 2,3-DIMERCAPTOSUCCINIC ACID 1 mg/1 N 20181231 71649-3776_83601fbd-2c88-44ef-a569-2a554bcae75e 71649-3776 HUMAN OTC DRUG XlentSkin Lanolin, Petrolatum OINTMENT TOPICAL 20170423 OTC MONOGRAPH FINAL part347 Jiangsu Jiang Shi Biological Technology Co., Ltd. LANOLIN; PETROLATUM 15.5; 30 g/100g; g/100g N 20181231 71654-001_217c86a2-d9b8-42fa-a5a7-2ebc7506eb2e 71654-001 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20170830 NDA NDA205766 SOUTHERN GAS AND SUPPLY, INC. dba Gas and Supply NITROGEN 99.5 L/L N 20181231 71654-002_a9b5696a-55cc-48a8-9423-913f3a477187 71654-002 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20170830 NDA NDA205767 SOUTHERN GAS AND SUPPLY, INC. dba Gas and Supply OXYGEN 99.5 L/L N 20181231 71657-0001_56fd134d-9991-6770-e054-00144ff88e88 71657-0001 HUMAN OTC DRUG Neutral handmade Blue honey SOAP TOPICAL 20170817 UNAPPROVED DRUG OTHER BNS Industry Co., Ltd. HONEY 8 g/110g N 20181231 71657-0002_56ff4b98-b531-39cb-e054-00144ff8d46c 71657-0002 HUMAN OTC DRUG Neutral handmade Purple honey SOAP TOPICAL 20170817 UNAPPROVED DRUG OTHER BNS Industry Co., Ltd. HONEY 9 g/110g N 20181231 71659-842_566b7e0d-3e30-3298-e054-00144ff88e88 71659-842 HUMAN OTC DRUG Guardania Pain CAPSAICIN CREAM TOPICAL 20170810 OTC MONOGRAPH NOT FINAL part348 LHP Pharma, Inc CAPSAICIN .25 mg/mL N 20181231 71662-000_6e1d665b-3ee6-4338-bcae-1849ecbda014 71662-000 HUMAN OTC DRUG Re-Lieved Lidocaine Patch Lidocaine Patch 4% PATCH TOPICAL 20170906 OTC MONOGRAPH NOT FINAL part348 Transfer Technology LIDOCAINE 18 mg/116cm2 N 20181231 71667-200_2c866b18-7837-425a-8ede-c18b3fa224e1 71667-200 HUMAN OTC DRUG EverGlam BB Natural Beige TITANIUM DIOXIDE, Octinoxate, and ZINC OXIDE CREAM TOPICAL 20170915 OTC MONOGRAPH FINAL part352 Glamcos L.L.C. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 79.2; 29.9; 19 mg/mL; mg/mL; mg/mL N 20181231 71672-010_d41ca22f-cf74-4e66-9ca7-85f845f63ecd 71672-010 HUMAN OTC DRUG ECO FACE 9 Allantoin SHAMPOO TOPICAL 20170801 OTC MONOGRAPH FINAL part347 Eco Face Shop ALLANTOIN 6 g/300mL N 20181231 71672-020_3bc99ec1-cd37-4742-8b75-116f6e8be426 71672-020 HUMAN OTC DRUG HAHALADY Allantoin SOAP TOPICAL 20170801 OTC MONOGRAPH FINAL part347 Eco Face Shop ALLANTOIN 2 g/100g N 20181231 71673-0001_56ff4b98-b530-39cb-e054-00144ff8d46c 71673-0001 HUMAN OTC DRUG DPC Aura Booster Mask NIACINAMIDE LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER MSCO NIACINAMIDE 2 g/100g N 20181231 71673-0002_57652f9d-72d0-f14a-e053-2991aa0a49a6 71673-0002 HUMAN OTC DRUG DPC COLLAGEN BOOSTER MASK ADENOSINE LIQUID TOPICAL 20170823 UNAPPROVED DRUG OTHER MSCO ADENOSINE .04 g/100g N 20181231 71673-0003_5700e699-8792-03ed-e054-00144ff8d46c 71673-0003 HUMAN OTC DRUG DPC Whitening Booster Mask NIACINAMIDE LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER MSCO NIACINAMIDE 2 g/100g N 20181231 71673-0004_57002112-3182-496e-e054-00144ff88e88 71673-0004 HUMAN OTC DRUG DPC Noblesse Suta Eye NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170701 UNAPPROVED DRUG OTHER MSCO ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71673-0005_576516ae-0e6b-c4e2-e053-2a91aa0a2e43 71673-0005 HUMAN OTC DRUG DPC Dual Master Vitamin C NIACINAMIDE, ADENOSINE LIQUID TOPICAL 20170823 UNAPPROVED DRUG OTHER MSCO ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71673-0006_57652f9d-72ed-f14a-e053-2991aa0a49a6 71673-0006 HUMAN OTC DRUG DPC Skin Up Perfection NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170823 UNAPPROVED DRUG OTHER MSCO ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71673-0007_577aea49-609b-3ede-e053-2991aa0a0283 71673-0007 HUMAN OTC DRUG DPC PINK AURA CUSHION NO.21 Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Isoamyl p-Methoxycinnamate, Niacinamide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Adenosine LIQUID TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 MSCO OCTINOXATE; AMILOXATE; OCTISALATE; BEMOTRIZINOL; TITANIUM DIOXIDE 7; 3; 3; 1.5; 13.3 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 71673-0008_577ab34f-ee07-0d90-e053-2991aa0a07b0 71673-0008 HUMAN OTC DRUG DPC PINK AURA CUSHION NO.23 Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Isoamyl p-Methoxycinnamate, Niacinamide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Adenosine LIQUID TOPICAL 20170701 OTC MONOGRAPH NOT FINAL part352 MSCO OCTINOXATE; AMILOXATE; OCTISALATE; BEMOTRIZINOL; TITANIUM DIOXIDE 7; 3; 3; 1.5; 12.7 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 71680-001_39046fba-f8b4-419f-a1a6-e9f71243cf92 71680-001 HUMAN OTC DRUG Dakota Muscle Relief MENTHOL, UNSPECIFIED FORM SPRAY TOPICAL 20080701 OTC MONOGRAPH NOT FINAL part348 LaShe Naturals, LLC MENTHOL, UNSPECIFIED FORM 60 mg/mL N 20181231 71680-002_9a1c7638-26c1-4eb6-8de8-36aafefc9e06 71680-002 HUMAN OTC DRUG Dakota Muscle Relief Roll-On MENTHOL, UNSPECIFIED FORM SOLUTION TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part348 LaShe Naturals, LLC MENTHOL, UNSPECIFIED FORM 60 mg/mL N 20181231 71682-0001_57ca4c0b-1cea-13bd-e053-2991aa0a6d8d 71682-0001 HUMAN OTC DRUG MOGUT Lactobacillus fermentum, Lactobacillus sakei, Leuconostoc holzapfelii, Leuconostoc mesenteroides, Enterococcus faecium LIQUID ORAL 20170801 UNAPPROVED DRUG OTHER COENBIO CO., LTD. LACTOBACILLUS REUTERI; ENTEROCOCCUS FAECIUM 20; 20 g/100mL; g/100mL N 20181231 71687-0005_609f9137-0b07-6c76-e053-2a91aa0affd5 71687-0005 HUMAN OTC DRUG Zapzyt Pore Cleaning Scrub Salicylic Acid GEL TOPICAL 20171216 OTC MONOGRAPH FINAL part333D Focus Consumer Healthcare, LLC SALICYLIC ACID 2 g/100g N 20181231 71687-0007_6078c812-9480-3be0-e053-2a91aa0aafb0 71687-0007 HUMAN OTC DRUG Zapzyt Acne Wash Cleanser Salicylic Acid GEL TOPICAL 20171216 OTC MONOGRAPH FINAL part333D Focus Consumer Healthcare, LLC SALICYLIC ACID 2 g/100g N 20181231 71687-0011_609f6380-1809-6343-e053-2991aa0a47be 71687-0011 HUMAN OTC DRUG Zapzyt Acne Treatment Gel Benzoyl Peroxide GEL TOPICAL 20171216 OTC MONOGRAPH FINAL part333D Focus Consumer Healthcare, LLC BENZOYL PEROXIDE 10 g/100g N 20181231 71687-1053_5fdcb871-d389-6352-e053-2991aa0a09da 71687-1053 HUMAN OTC DRUG Benzodent Benzocaine CREAM TOPICAL 20171208 OTC MONOGRAPH NOT FINAL part356 Focus Consumer Healthcare, LLC BENZOCAINE .2 g/g N 20181231 71687-2010_6077c4c1-a3b8-7a7a-e053-2a91aa0a8a67 71687-2010 HUMAN OTC DRUG Blue Star Medicated camphor OINTMENT TOPICAL 20171013 OTC MONOGRAPH NOT FINAL part348 Focus Consumer Healthcare, LLC CAMPHOR (SYNTHETIC) 12.4 mg/100g N 20181231 71687-3003_60b3286d-5699-df50-e053-2991aa0afbe2 71687-3003 HUMAN OTC DRUG Pamprin Multi-Symptom Maximum Strength Acetaminophen, Pamabrom, Pyrilamine maleate TABLET ORAL 20160601 OTC MONOGRAPH NOT FINAL part343 Focus Consumer Healthcare, LLC PYRILAMINE MALEATE; PAMABROM; ACETAMINOPHEN 15; 25; 500 mg/1; mg/1; mg/1 N 20181231 71687-3006_603bb0ba-9ea0-4d2a-e053-2991aa0ab229 71687-3006 HUMAN OTC DRUG Pamprin Max Menstrual Pain Relief Acetaminophen and Aspirin and Caffeine TABLET ORAL 20171018 OTC MONOGRAPH NOT FINAL part343 Focus Consumer Healthcare, LLC ACETAMINOPHEN; ASPIRIN; CAFFEINE 250; 250; 65 mg/1; mg/1; mg/1 N 20181231 71687-3102_5bd96c05-bf94-ce70-e053-2a91aa0a95ec 71687-3102 HUMAN OTC DRUG Premsyn pms Premenstrual Pain Relief Acetaminophen and Pamabrom and Pyrilamine maleate PILL ORAL 20171013 OTC MONOGRAPH NOT FINAL part343 Focus Consumer Healthcare, LLC ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 71687-7773_60dce1ad-1297-396d-e053-2a91aa0a670f 71687-7773 HUMAN OTC DRUG Herpecin L Dimethicone and Meradimate and Octinoxate and Octisalate and Oxybenzone STICK TOPICAL 20171013 OTC MONOGRAPH NOT FINAL part352 Focus Consumer Healthcare, LLC DIMETHICONE; MERADIMATE; OCTINOXATE; OCTISALATE; OXYBENZONE 1; 5; 7.5; 5; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 71690-201_3fa98c98-03ae-4c00-beb7-3b0b49f46a78 71690-201 HUMAN OTC DRUG Aegis Daily Facial SPF 25 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, and OCTOCRYLENE LOTION TOPICAL 20171020 OTC MONOGRAPH FINAL part352 JNTLee Inc. dba Panacea AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 29; 90; 68; 45; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71692-001_58eb2d50-679c-50f1-e053-2a91aa0aec36 71692-001 HUMAN OTC DRUG Tinted Moisturizer SPF 30 SPF 30 Octinoxate, Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20170908 OTC MONOGRAPH FINAL part352 Regi U.S. Inc ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE 3; 7.5; 3.5 g/100g; g/100g; g/100g N 20181231 71693-100_57d86ff8-2ad0-80f1-e053-2a91aa0a83ae 71693-100 HUMAN OTC DRUG Gentle Therapy Zinc pyrithione, Panthenol, Niacinamide, Biotin SHAMPOO TOPICAL 20170828 UNAPPROVED DRUG OTHER SOLEO PYRITHIONE ZINC; PANTHENOL; NIACINAMIDE; BIOTIN 15.75; 3.75; 2.25; .45 g/750mL; g/750mL; g/750mL; g/750mL N 20181231 71693-101_57dae7c8-cc2d-1c65-e053-2991aa0ac58a 71693-101 HUMAN OTC DRUG Gentle Therapy Treatment Panthenol LIQUID TOPICAL 20170828 UNAPPROVED DRUG OTHER SOLEO PANTHENOL 3.75 g/750mL N 20181231 71694-0001_57de50d3-c9f7-5576-e053-2a91aa0a7937 71694-0001 HUMAN OTC DRUG PORE CARE Lotus Mask Allantoin LIQUID TOPICAL 20170801 UNAPPROVED DRUG OTHER Feelxo ALLANTOIN .1 g/100mL N 20181231 71694-0002_57f069a2-a080-792a-e053-2a91aa0af1c6 71694-0002 HUMAN OTC DRUG GLOWING Marigold Mask Glycerin LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 Feelxo GLYCERIN 5 g/100mL N 20181231 71694-0003_57f056a2-898a-2db5-e053-2991aa0a3831 71694-0003 HUMAN OTC DRUG FIRMING Camellia Mask Glycerin LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 Feelxo GLYCERIN 5 g/100mL N 20181231 71694-0004_57f069a2-a08d-792a-e053-2a91aa0af1c6 71694-0004 HUMAN OTC DRUG HYDRA Rose Mask Glycerin LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part347 Feelxo GLYCERIN 6 g/100mL N 20181231 71694-0005_57e40141-1fa6-ca3b-e053-2a91aa0a52dd 71694-0005 HUMAN OTC DRUG Charcoal Nose Mask Blackhead Remover Witch Hazel LIQUID TOPICAL 20170801 OTC MONOGRAPH FINAL part347 Feelxo WITCH HAZEL .01 g/100g N 20181231 71695-200_580e6171-3975-f9a9-e053-2a91aa0af04b 71695-200 HUMAN OTC DRUG SOFTCIDE CHLOROXYLENOL SOAP TOPICAL 20170410 OTC MONOGRAPH NOT FINAL part333A VWR International CHLOROXYLENOL .001 mg/100mL N 20181231 71696-001_57ea2aff-682e-c6f6-e053-2991aa0a9732 71696-001 HUMAN OTC DRUG SHILLS ACNE Purifying Peel Off Black Mask PYRITHIONE ZINC SOLUTION TOPICAL 20170828 OTC MONOGRAPH FINAL part358H Lin Quan Enterprises Co., Ltd. PYRITHIONE ZINC .95 g/100mL N 20181231 71698-100_61507a3d-ec88-45fa-e053-2a91aa0aaea5 71698-100 HUMAN OTC DRUG ISTINA Intense Revitalizing Serum Niacinamide GEL TOPICAL 20171031 UNAPPROVED DRUG OTHER NBM INC. NIACINAMIDE 2 g/mL N 20181231 71698-101_61508222-0a01-c8ca-e053-2a91aa0a6ef8 71698-101 HUMAN OTC DRUG ISTINA Nourishing Age-defying Hydration Cream Niacinamide CREAM TOPICAL 20171031 UNAPPROVED DRUG OTHER NBM INC. NIACINAMIDE 2 g/mL N 20181231 71698-102_61509674-ddff-7ecf-e053-2991aa0a733e 71698-102 HUMAN OTC DRUG ISTINA Radiating Anti-Wrinkle Eye Serum Niacinamide GEL TOPICAL 20171031 UNAPPROVED DRUG OTHER NBM INC. NIACINAMIDE 2 g/mL N 20181231 71700-112_61986adc-0d5c-ed88-e053-2991aa0ac90a 71700-112 HUMAN OTC DRUG GETTIK Hair Regrowth Treatment MINOXIDIL 5% LIQUID TOPICAL 20171001 ANDA ANDA074588 GETTIK International LLC MINOXIDIL 50 mg/mL N 20181231 71702-010_135597f2-0b90-45af-9a4a-fee4d371837c 71702-010 HUMAN OTC DRUG CLEMATIS BASE CUSHION Octinoxate, Titanium Dioxide, Octisalate, Zinc Oxide POWDER TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Coshub Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE .97; .78; .65; .25 g/13g; g/13g; g/13g; g/13g N 20181231 71702-020_5f11da62-b8bb-4031-9ccf-e4424da130d7 71702-020 HUMAN OTC DRUG CLEMATIS Fluffy Matte Cushion 21 Light Beige Titanium Dioxide, Octinoxate, Zinc Oxide POWDER TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Coshub Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .98; .91; .12 g/13g; g/13g; g/13g N 20181231 71702-030_b1be8451-0d29-475b-ae70-4f1279b80a7c 71702-030 HUMAN OTC DRUG CLEMATIS Fluffy Matte Cushion 23 Natural Beige Titanium Dioxide, Octinoxate, Zinc Oxide POWDER TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Coshub Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .98; .91; .12 g/13g; g/13g; g/13g N 20181231 71702-040_e5ab19c9-1ea3-42df-9926-73f17eebd5fe 71702-040 HUMAN OTC DRUG CLEMATIS FLUFFY MATTE CUSHION 25 Soft Beige Titanium Dioxide, Octinoxate, Zinc Oxide POWDER TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Coshub Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .98; .91; .12 g/13g; g/13g; g/13g N 20181231 71702-050_8d932fe5-85b1-4288-acea-04e4c8c4d9db 71702-050 HUMAN OTC DRUG CLEMATIS FLUFFY MATTE CUSHION 27 Beige Titanium Dioxide, Octinoxate, Zinc Oxide POWDER TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Coshub Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE .98; .91; .12 g/13g; g/13g; g/13g N 20181231 71702-060_8f3094f9-6b4a-4a21-8515-4de704d60a1c 71702-060 HUMAN OTC DRUG CLEMATIS HYDRO PROTECTIVE UV SUN ESSENCE Octinoxate, Homosalate, Octisalate GEL TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Coshub Co., Ltd. OCTINOXATE; HOMOSALATE; OCTISALATE 3.5; 3; 2.25 g/50mL; g/50mL; g/50mL N 20181231 71702-070_63747906-31fe-4c7c-a647-72abec8e0279 71702-070 HUMAN OTC DRUG CLEMATIS Melting Fluffy sti ck foundation 21 Light Beige Titanium Dioxide STICK TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Coshub Co., Ltd. TITANIUM DIOXIDE 1.31 g/8g N 20181231 71702-080_1e0d35af-fd75-4dda-9786-7557e9685e34 71702-080 HUMAN OTC DRUG CLEMATIS Melting Fluffy sti ck foundation 23 Natural Beige Titanium Dioxide STICK TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Coshub Co., Ltd. TITANIUM DIOXIDE 1.31 g/8g N 20181231 71702-090_e3f5ad72-c2d3-4b7c-975d-3b2047b9a6cd 71702-090 HUMAN OTC DRUG CLEMATIS Morning dew BB 21 Light Beige Titanium Dioxide CREAM TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Coshub Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.06; 3.5; 2 g/50mL; g/50mL; g/50mL N 20181231 71702-100_b8a4f38d-1443-4c0f-b4f3-6099018c1e84 71702-100 HUMAN OTC DRUG CLEMATIS Morning dew BB 23 Natural Beige Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Coshub Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 4.06; 3.5; 2 g/50mL; g/50mL; g/50mL N 20181231 71702-110_9d2c27ed-d394-4764-86fd-a3d2293a68e8 71702-110 HUMAN OTC DRUG CLEMATIS Morning Dew CC Octinoxate, Titanium Dioxide, Octisalate, Homosalate CREAM TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Coshub Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; HOMOSALATE 3.5; 1.69; 1.5; 1.5 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 71703-0001_57db85ca-f2ab-62dc-e053-2a91aa0aa476 71703-0001 HUMAN OTC DRUG JEUNESSENG EYE BAG REMOVAL ADENOSINE CREAM TOPICAL 20170829 UNAPPROVED DRUG OTHER Frontier EDU ADENOSINE .04 g/100mL N 20181231 71704-001_58ad4ae2-6142-0eea-e053-2a91aa0aac60 71704-001 HUMAN OTC DRUG House Living Sodium Monofluorophosphate PASTE DENTAL 20170913 OTC MONOGRAPH NOT FINAL part356 Guangzhou Beauty Cosmetic Co., Ltd SODIUM MONOFLUOROPHOSPHATE .76 g/100g N 20181231 71704-002_591356ba-34c6-dd3f-e053-2991aa0a40f6 71704-002 HUMAN OTC DRUG House Living SODIUM FLUORIDE,Potassium Nitrate PASTE DENTAL 20160710 OTC MONOGRAPH NOT FINAL part356 Guangzhou Beauty Cosmetic Co., Ltd POTASSIUM NITRATE; SODIUM FLUORIDE 5; .15 g/100g; g/100g N 20181231 71706-060_8f5c6b59-2b8b-4c3a-b249-40a08df88702 71706-060 HUMAN OTC DRUG Benson Bottom Paint Zinc Oxide CREAM TOPICAL 20171001 OTC MONOGRAPH FINAL part346 Benson's Bottom Paint , Inc ZINC OXIDE 220 mg/g N 20181231 71707-001_1e28722d-be7b-42cf-ba5b-00f0dae65d1a 71707-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20171101 NDA NDA205865 TULSA GAS & GEAR, LLC OXYGEN 99 L/L N 20181231 71707-002_c52021f3-226d-4f2a-bdde-31fe833f48f7 71707-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20171026 NDA NDA205866 TULSA GAS & GEAR, LLC NITROGEN 99.1 L/L N 20181231 71709-110_5df6adc9-79fe-66ef-e053-2991aa0a75ce 71709-110 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20171114 ANDA ANDA090564 Metcure Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 71709-111_5df6adc9-79fe-66ef-e053-2991aa0a75ce 71709-111 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20171114 ANDA ANDA090564 Metcure Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 850 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 71709-112_5df6adc9-79fe-66ef-e053-2991aa0a75ce 71709-112 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20171114 ANDA ANDA090564 Metcure Pharmaceuticals, Inc. METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 71710-0001_587f3612-373e-7341-e053-2a91aa0aff89 71710-0001 HUMAN OTC DRUG Purigo Silicon Oxide, Potassium, Borax, Calcium Carbonate LIQUID TOPICAL 20170801 UNAPPROVED DRUG OTHER Sun Jin Yu Ji Co POTASSIUM; SILICON DIOXIDE; CALCIUM CARBONATE 9.3; 31; 18 g/100mL; g/100mL; g/100mL N 20181231 71711-0001_5908477d-87fb-b126-e053-2991aa0a5748 71711-0001 HUMAN OTC DRUG Super Amazing Revolution For Eye NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170801 UNAPPROVED DRUG OTHER Aimeeskinlab Co., Ltd. ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71711-0002_590b4895-c5d3-4e8c-e053-2991aa0a6f64 71711-0002 HUMAN OTC DRUG Super Amazing Revolution For Face NIACINAMIDE, ADENOSINE CREAM TOPICAL 20170801 UNAPPROVED DRUG OTHER Aimeeskinlab Co., Ltd. ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71711-0003_591ffd18-fbd9-9087-e053-2991aa0ab340 71711-0003 HUMAN OTC DRUG Super Amazing Revolution For MultiLotion ADENOSINE LOTION TOPICAL 20170801 UNAPPROVED DRUG OTHER Aimeeskinlab Co., Ltd. ADENOSINE .05 g/100mL N 20181231 71711-0004_59201330-297e-f684-e053-2a91aa0a3b13 71711-0004 HUMAN OTC DRUG Super Amazing Revolution For Secret ADENOSINE CREAM TOPICAL 20170801 UNAPPROVED DRUG OTHER Aimeeskinlab Co., Ltd. ADENOSINE .05 g/100mL N 20181231 71712-001_57ea4bd2-d45f-4394-e053-2991aa0a2bb4 71712-001 HUMAN OTC DRUG Clean Fresh Sunblock Sunscreen SPF 30 Continuous HOMOSALATE SPRAY TOPICAL 20170829 OTC MONOGRAPH NOT FINAL part352 Wuxi Huoban Daily-use Chemical Science and Technology Co., Ltd. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 5; 7; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 71713-095_6195d34f-48d8-8190-e053-2a91aa0a8638 71713-095 HUMAN OTC DRUG Keeps Minoxidil 5% LIQUID TOPICAL 20171115 ANDA ANDA074588 Thirty Madison Inc MINOXIDIL 50 mg/mL N 20181231 71714-020_6e5aada8-d463-42c5-b063-ad45b8a3ba01 71714-020 HUMAN OTC DRUG Tiege Hanley AM Morning Facial Moisturizer with SPF20 octinoxate, Avobenzone, and octocrylene LOTION TOPICAL 20170930 OTC MONOGRAPH FINAL part352 Tiege hanley OCTINOXATE; AVOBENZONE; OCTOCRYLENE 55; 25; 20 mg/mL; mg/mL; mg/mL N 20181231 71717-101_621db55b-f37c-1a98-e053-2991aa0a15a9 71717-101 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET ORAL 20171201 ANDA ANDA204359 Megalith Pharmaceuticals Inc CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20191231 71717-104_6155d624-967f-d876-e053-2991aa0a4120 71717-104 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, COATED ORAL 20171218 ANDA ANDA205096 Megalith Pharmaceuticals Inc METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 71717-106_6155d624-967f-d876-e053-2991aa0a4120 71717-106 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, COATED ORAL 20171218 ANDA ANDA205096 Megalith Pharmaceuticals Inc METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 71718-001_b8d4fd14-20bf-40d1-a053-b3098cd0eec4 71718-001 HUMAN OTC DRUG Bare 20 Urea GEL TOPICAL 20170801 UNAPPROVED DRUG OTHER Scientific Solutions Global, LLC UREA 20 g/100g N 20191231 71718-002_957a0302-16f4-4345-b1f2-dfca1c5799de 71718-002 HUMAN OTC DRUG Bare 40 UREA GEL TOPICAL 20170801 UNAPPROVED DRUG OTHER Scientific Solutions Global, LLC UREA 40 g/100g N 20191231 71718-003_ac403f80-7a1e-4413-afa8-c6ba368f75e3 71718-003 HUMAN OTC DRUG Bare 40 SA Urea GEL TOPICAL 20170801 UNAPPROVED DRUG OTHER Scientific Solutions Global, LLC UREA 40 g/100g N 20191231 71718-004_8d79f348-ac4f-4f7b-8b80-2a65f742cf27 71718-004 HUMAN OTC DRUG Bare 40 HA Urea GEL TOPICAL 20170801 UNAPPROVED DRUG OTHER Scientific Solutions Global, LLC UREA 40 g/100g N 20191231 71718-111_dfdb31d9-c2d2-46e5-a0dd-eebea4b15ca4 71718-111 HUMAN OTC DRUG BioTemper Menthol LIQUID TOPICAL 20170803 OTC MONOGRAPH NOT FINAL part348 Scientific Solutions Global Llc MENTHOL, UNSPECIFIED FORM 10 g/100mL N 20181231 71725-010_3aa710e9-7f02-4d81-93e3-e811dea4a29e 71725-010 HUMAN OTC DRUG PRPL dual cover cushion No 21 cre am ivory Cushion Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Derma&lab Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.31; .67; .4 g/10g; g/10g; g/10g N 20181231 71725-020_8eed9f15-788c-43c2-affe-3cec99cd7f4f 71725-020 HUMAN OTC DRUG PRPL dual cover cushion No 21 cre am ivory Conceal Balm Titanium Dioxide POWDER TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Derma&lab Co., Ltd. TITANIUM DIOXIDE 1.43 g/6g N 20181231 71725-030_0013790b-1fa4-4f50-a302-0d7fbcf4d882 71725-030 HUMAN OTC DRUG PRPL dual cover cushion No 23 vanilla beige Cushion Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Derma&lab Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.31; .67; .4 g/10g; g/10g; g/10g N 20181231 71725-040_76d3b54c-7e86-4fe8-bb70-6e4b65d18ae5 71725-040 HUMAN OTC DRUG PRPL dual cover cushion No 23 vanilla beige Conceal Balm Titanium Dioxide POWDER TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Derma&lab Co., Ltd. TITANIUM DIOXIDE 1.43 g/6g N 20181231 71727-100_59d00c0b-8f4f-46df-e053-2a91aa0a47e0 71727-100 HUMAN OTC DRUG EMP COLLAGEN BOOST Niacinamide, Allantoin PATCH TOPICAL 20170922 UNAPPROVED DRUG OTHER iMode Korea, Inc. NIACINAMIDE; ALLANTOIN 1.75; .075 g/25mL; g/25mL N 20181231 71727-101_5a0f4448-ecae-1e36-e053-2a91aa0a0df3 71727-101 HUMAN OTC DRUG MICRO DUST DETOX Panthenol, Allantoin PATCH TOPICAL 20170925 UNAPPROVED DRUG OTHER iMode Korea, Inc. PANTHENOL; ALLANTOIN .162; .081 g/27mL; g/27mL N 20181231 71727-102_61eb9b86-40d7-ac21-e053-2a91aa0a18da 71727-102 HUMAN OTC DRUG MARINE PURIFYING Panthenol, Allantoin PATCH TOPICAL 20180103 UNAPPROVED DRUG OTHER iMode Korea, Inc. PANTHENOL; ALLANTOIN .162; .081 mg/27mL; mg/27mL N 20191231 71730-042_619619ab-05ce-c750-e053-2a91aa0aa152 71730-042 HUMAN OTC DRUG hims Minoxidil 5% LIQUID TOPICAL 20171101 ANDA ANDA075518 Clubroom, Inc. MINOXIDIL 50 mg/mL N 20181231 71732-010_de5b76b0-e802-4a13-8ff7-ff17b6eebc62 71732-010 HUMAN OTC DRUG PurpleU BAOBAB FIRMING Dimethicone CREAM TOPICAL 20171001 OTC MONOGRAPH FINAL part347 Recipe Co., Ltd. DIMETHICONE .5 g/50mL N 20181231 71732-020_cb43d080-b0fe-49be-91ae-5e933e162c17 71732-020 HUMAN OTC DRUG PurpleU BAOBAB FACE LEVOMENOL OIL TOPICAL 20171001 UNAPPROVED DRUG OTHER Recipe Co., Ltd. LEVOMENOL .07 g/15mL N 20181231 71734-201_972b3dde-977d-4b7f-8a01-03797f92087a 71734-201 HUMAN OTC DRUG Freeman Packaging Hand Sanitizer ALCOHOL LIQUID TOPICAL 20171009 OTC MONOGRAPH NOT FINAL part333E JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. ALCOHOL 62 mL/100mL N 20181231 71734-202_5fc8221b-7d69-45b2-a720-f12ea913f840 71734-202 HUMAN OTC DRUG Alcohol Wipes Alcohol CLOTH TOPICAL 20171009 OTC MONOGRAPH NOT FINAL part333E JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. ALCOHOL .31 mL/mL N 20181231 71734-203_d3c4da95-60fe-451e-8566-5b87b24c44c9 71734-203 HUMAN OTC DRUG Hand Wipes Chlorhexidine Digluconate and BENZETHONIUM CHLORIDE CLOTH TOPICAL 20171009 OTC MONOGRAPH NOT FINAL part333A JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. CHLORHEXIDINE GLUCONATE; BENZETHONIUM CHLORIDE .1; .08 g/g; g/g N 20181231 71734-204_7b66fbd8-0469-4370-b7d0-126ab69d4d49 71734-204 HUMAN OTC DRUG KidzStuff Hand Sanitizer ALCOHOL LIQUID TOPICAL 20180117 OTC MONOGRAPH NOT FINAL part333E JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. ALCOHOL 62 g/100g N 20191231 71738-0001_590c19a2-5880-04ce-e053-2991aa0a7631 71738-0001 HUMAN OTC DRUG LOHASYS 2 SHIELD SUN BLOCK PRIMER Titanium dioxide CREAM TOPICAL 20170913 OTC MONOGRAPH FINAL part352 Netcos Co., Ltd. TITANIUM DIOXIDE 5.35 g/100mL N 20181231 71738-0002_591b4d18-ee03-c5bf-e053-2a91aa0a70a4 71738-0002 HUMAN OTC DRUG LOHASYS MAYU ULTRA MOISTURE CARE glycerin CREAM TOPICAL 20170913 OTC MONOGRAPH NOT FINAL part347 Netcos Co., Ltd. GLYCERIN; ADENOSINE 5; .04 g/100mL; g/100mL N 20181231 71738-0003_591b47ab-5b49-acf7-e053-2991aa0adebf 71738-0003 HUMAN OTC DRUG LOHASYS MAYU ULTRA MOISTURE CARE HAND glycerin CREAM TOPICAL 20170913 OTC MONOGRAPH NOT FINAL part347 Netcos Co., Ltd. GLYCERIN; ADENOSINE 30; .04 g/100mL; g/100mL N 20181231 71738-0004_591bcd4b-97ba-6487-e053-2991aa0a6620 71738-0004 HUMAN OTC DRUG LOHASYS MAYU ULTRA MOISTURE CARE TONER glycerin LIQUID TOPICAL 20170913 OTC MONOGRAPH NOT FINAL part347 Netcos Co., Ltd. GLYCERIN; ADENOSINE 3; .04 g/100mL; g/100mL N 20181231 71738-0005_591bcd4b-97c9-6487-e053-2991aa0a6620 71738-0005 HUMAN OTC DRUG LOHASYS MAYU ULTRA MOISTURE glycerin EMULSION TOPICAL 20170913 OTC MONOGRAPH NOT FINAL part347 Netcos Co., Ltd. GLYCERIN; ADENOSINE 8; .04 g/100mL; g/100mL N 20181231 71740-112_994b9ce3-f39a-48b1-b6dd-619e8d3336e0 71740-112 HUMAN PRESCRIPTION DRUG SSKI Potassium Iodide SOLUTION ORAL 20171113 UNAPPROVED DRUG OTHER Avondale Pharmaceuticals, LLC POTASSIUM IODIDE 1 g/mL N 20181231 71740-201_103c9776-f102-476a-9588-36f146d529f0 71740-201 HUMAN PRESCRIPTION DRUG Niacor niacin TABLET ORAL 20000503 ANDA ANDA040378 Avondale Pharmaceuticals, LLC NIACIN 500 mg/1 Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient] N 20181231 71742-0001_33bf81ec-4693-464f-ab65-61cce5756124 71742-0001 HUMAN OTC DRUG Neuro-Pro T007 Gaba, L-Dopa, Norepinephrine, Serotonin, Adrenocorticotrophin, Anacardium Orientale, Arsenicum Album, Baryta Carbonica, Calcarea Carbonica, Calcarea Phosphorica, Hyoscyamus Niger, Lycopodium Clavatum, Stramonium LIQUID ORAL 20171018 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd .GAMMA.-AMINOBUTYRIC ACID; LEVODOPA; NOREPINEPHRINE; SEROTONIN HYDROCHLORIDE; CORTICOTROPIN; ANACARDIUM OCCIDENTALE FRUIT; ARSENIC TRIOXIDE; BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; HYOSCYAMUS NIGER; LYCOPODIUM CLAVATUM SPORE; DATURA STRAMONIUM 6; 6; 6; 6; 8; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 71742-0002_8344df86-e3cf-425b-b13d-0e1619dced1e 71742-0002 HUMAN OTC DRUG Arthri-Joint T008 Apis Mellifica, Bryonia (Alba), Causticum, Colchicum Autumnale, Kali Carbonicum, Kalmia Latifolia, Ledum Palustre, Pulsatilla (Vulgaris), Rhododendron Chrysanthum, Rhus Tox LIQUID ORAL 20171019 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd APIS MELLIFERA; BRYONIA ALBA ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; POTASSIUM CARBONATE; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; PULSATILLA VULGARIS; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF 30; 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71742-0003_07ceb79a-af82-4cc1-89cf-8263c9dea39d 71742-0003 HUMAN OTC DRUG Vascu-Pro T009 Cactus Grandiflorus, Hamamelis Virginiana, Valeriana Officinalis, Arteria Suis, Heart (Suis), Arnica Montana, Aurum Metallicum, Baryta Muriatica, Cholesterinum, Lecithin, Magnesia Muriatica, Oxalicum Acidum, Phosphorus LIQUID ORAL 20171019 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd SELENICEREUS GRANDIFLORUS STEM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; VALERIAN; SUS SCROFA ARTERY; PORK HEART; ARNICA MONTANA; GOLD; BARIUM CHLORIDE DIHYDRATE; CHOLESTEROL; LECITHIN, SOYBEAN; MAGNESIUM CHLORIDE; OXALIC ACID; PHOSPHORUS 3; 3; 3; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71742-0004_e568062e-50f9-4442-904a-72e7f33da401 71742-0004 HUMAN OTC DRUG Female Vitality T010 Cimicifuga Racemosa, Fucus Vesiculosus, Oophorinum (Suis), Hypophysis Suis, Thyroidinum (Suis), Graphites, Lachesis Mutus, Natrum Muriaticum, Pulsatilla (Pratensis), Sepia LIQUID ORAL 20171020 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd BLACK COHOSH; FUCUS VESICULOSUS; SUS SCROFA OVARY; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; GRAPHITE; LACHESIS MUTA VENOM; SODIUM CHLORIDE; ANEMONE PRATENSIS; SEPIA OFFICINALIS JUICE 3; 3; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71742-0006_76adb01c-5f32-4d49-abfc-adfbd560d699 71742-0006 HUMAN OTC DRUG Sleep Well T012 Arsenicum Album, Avena Sativa, Coffea Cruda, Kali Carbonicum, Magnesia Carbonica, Nux Vomica, Passiflora Incarnata, Sepia, Valeriana Officinalis LIQUID ORAL 20171024 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; POTASSIUM CARBONATE; MAGNESIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; SEPIA OFFICINALIS JUICE; VALERIAN 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71742-0007_34c0d43a-5dbe-437c-8ff4-be9c0508e68b 71742-0007 HUMAN PRESCRIPTION DRUG Lymph Detox T013 Geranium Robertianum, Nasturtium Aquaticum, Aloe, Myosotis Arvensis, Scrophularia Nodosa, Teucrium Scorodonia, Apis Mellifica, Equisetum Hyemale, Fumaria Officinalis, Natrum Sulphuricum, Phytolacca Decandra, Pinus Sylvestris, Veronica Officinalis, Gentiana Lutea, Juglans Regia, Sarsaparilla (Smilax Regelii) Baryta Carbonica, Hepar Sulphuris Calcareum, Mercurius Cyanatus, Ferrum Iodatum, Aranea Diadema, Calcarea Phosphorica, Parathyroid Gland (Bovine), Thymus (Suis), Thyroidinum (Suis) LIQUID ORAL 20171024 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd GERANIUM ROBERTIANUM; NASTURTIUM OFFICINALE; ALOE; MYOSOTIS ARVENSIS; SCROPHULARIA NODOSA; TEUCRIUM SCORODONIA FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE; FUMARIA OFFICINALIS FLOWERING TOP; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; VERONICA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; JUGLANS REGIA FRUIT RIND, IMMATURE; JUGLANS REGIA LEAF; SMILAX REGELII ROOT; BARIUM CARBONATE; CALCIUM SULFIDE; MERCURIC CYANIDE; FERROUS IODIDE; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; BOS TAURUS PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID 3; 3; 3; 3; 3; 4; 4; 4; 4; 4; 4; 4; 5; 5; 5; 5; 6; 8; 8; 8; 8; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],Bee Venoms [Chemical/Ingredient],Standardized Insect Venom Allergenic Extract [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 71742-0008_55ca2805-9a48-4673-8185-173cddb70edb 71742-0008 HUMAN OTC DRUG Heavy Metal Detox T014 Allium Sativum, Avena Sativa, Berberis Vulgaris, Lappa Major, Phytolacca Decandra, Solidago Virgaurea, Lycopodium Clavatum, Nux Vomica, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum LIQUID ORAL 20171026 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd GARLIC; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; ALUMINUM; ANTIMONY TRISULFIDE; SILVER; ARSENIC TRIOXIDE; GOLD; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; GADOLINIUM; GERMANIUM SESQUIOXIDE; HOLMIUM; INDIUM; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; OSMIUM; PALLADIUM; PLATINUM; LEAD; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; TIN; STRONTIUM CARBONATE; TERBIUM; THALLIUM; URANYL NITRATE HEXAHYDRATE; VANADIUM; YTTERBIUM OXIDE; ZINC; LANTHANUM; NIOBIUM; TANTALUM 3; 3; 3; 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 14; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 71742-0009_5e65d625-8b6c-48af-84c6-f91fdf8cf01d 71742-0009 HUMAN OTC DRUG Glucose Control T015 Syzygium Jambolanum, Glandula Suprarenalis Suis, Hydrastis Canadensis, Hypophysis Suis, Pancreas Suis, Phaseolus, Aceticum Acidum, Lacticum Acidum, Phosphoricum Acidum, Phosphorus, Uranium Nitricum LIQUID ORAL 20171026 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd SYZYGIUM CUMINI SEED; SUS SCROFA ADRENAL GLAND; GOLDENSEAL; SUS SCROFA PITUITARY GLAND; SUS SCROFA PANCREAS; KIDNEY BEAN; ACETIC ACID; LACTIC ACID; PHOSPHORIC ACID; PHOSPHORUS; URANYL NITRATE HEXAHYDRATE 3; 6; 6; 6; 6; 9; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71742-0010_d950f4c8-16f9-4ea0-9535-884e0c2d7816 71742-0010 HUMAN OTC DRUG Respiro-Pro T016 Ammonium Muriaticum, Antimonium Tartaricum, Arsenicum Album, Bryonia (Alba), Calcarea Carbonica, Lobelia Inflata, Natrum Sulphuricum, Phosphorus, Spongia Tosta LIQUID ORAL 20171026 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd AMMONIUM CHLORIDE; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; LOBELIA INFLATA; SODIUM SULFATE; PHOSPHORUS; SPONGIA OFFICINALIS SKELETON, ROASTED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71742-0011_503bf725-9e85-417d-97f3-03a7b836910c 71742-0011 HUMAN OTC DRUG Kidney-Pro T017 Berberis Vulgaris, Petroselinum Sativum, Sabal Serrulata, Uva Ursi, Cantharis, Lithium Carbonicum, Mercurius Corrosivus, Pareira Brava, Sarsaparilla (Smilax Regelii), Solidago Virgaurea LIQUID ORAL 20171026 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd BERBERIS VULGARIS ROOT BARK; PETROSELINUM CRISPUM; SAW PALMETTO; ARCTOSTAPHYLOS UVA-URSI LEAF; LYTTA VESICATORIA; LITHIUM CARBONATE; MERCURIC CHLORIDE; CHONDRODENDRON TOMENTOSUM ROOT; SMILAX REGELII ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP 3; 3; 3; 3; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71742-0012_53f1621b-b6d5-4b35-baf3-1657e67cd5c1 71742-0012 HUMAN OTC DRUG Spleen-Pro T018 Spleen (Suis), Arsenicum Album, Carbo Vegetabilis, Ceanothus Americanus, Chininum Sulphuricum, Ignatia Amara, Iodium, Natrum Muriaticum, Nitricum Acidum, Phosphoricum Acidum, Phosphorus LIQUID ORAL 20171026 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd SUS SCROFA SPLEEN; ARSENIC TRIOXIDE; ACTIVATED CHARCOAL; CEANOTHUS AMERICANUS LEAF; QUININE SULFATE; STRYCHNOS IGNATII SEED; IODINE; SODIUM CHLORIDE; NITRIC ACID; PHOSPHORIC ACID; PHOSPHORUS 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71742-0013_7cc99dd9-f722-44e6-a224-a3a40d47af5a 71742-0013 HUMAN OTC DRUG Thyro-Pro T019 Fucus Vesiculosus, Spongia Tosta, Glandula Suprarenalis Suis, Hypophysis Suis, Thyroidinum (Suis), Bromium, Calcarea Carbonica, Iodium, Lachesis Mutus, Pulsatilla (Vulgaris) LIQUID ORAL 20171026 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd FUCUS VESICULOSUS; SPONGIA OFFICINALIS SKELETON, ROASTED; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; SUS SCROFA THYROID; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; IODINE; LACHESIS MUTA VENOM; PULSATILLA VULGARIS 3; 3; 6; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71742-0014_a7260dff-03f1-4824-bdff-1359f37b58f2 71742-0014 HUMAN OTC DRUG HGH-Pro T020 Human Growth Hormone, Hypophysis Suis, Hepar Suis LIQUID ORAL 20171031 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd SOMATROPIN; SUS SCROFA PITUITARY GLAND; PORK LIVER 30; 30; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71742-0015_3f1726fb-6da0-4aac-99c3-bb88968a3ef3 71742-0015 HUMAN OTC DRUG Male Vitality T021 Damiana, Korean Ginseng, Populus Tremuloides, Nuphar Luteum, Arnica Montana, Carduus Marianus, Galium Aparine, Lactuca Virosa, Caladium Seguinum, Hepar Suis, Orchitinum (Suis), Thymus (Suis), Glandula Suprarenalis Suis, Hypophysis Suis, Thyroidinum (Suis), Testosterone, Phosphoricum Acidum, Thuja Occidentalis LIQUID ORAL 20171031 UNAPPROVED HOMEOPATHIC Guangzhou Renuma Medical Systems Co., Ltd TURNERA DIFFUSA LEAFY TWIG; ASIAN GINSENG; POPULUS TREMULOIDES BARK; NUPHAR LUTEUM ROOT; ARNICA MONTANA; MILK THISTLE; GALIUM APARINE; LACTUCA VIROSA; DIEFFENBACHIA SEGUINE; PORK LIVER; SUS SCROFA TESTICLE; SUS SCROFA THYMUS; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; THYROID, PORCINE; TESTOSTERONE; PHOSPHORIC ACID; THUJA OCCIDENTALIS LEAFY TWIG 1; 1; 1; 2; 3; 3; 3; 3; 6; 6; 6; 6; 12; 12; 12; 30; 200; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 71745-001_829ba22b-5e0e-48f4-b7b4-7a61c2c0d654 71745-001 HUMAN OTC DRUG Fragrance Free Sanitizing Wipes Benzalkonium Chloride CLOTH CUTANEOUS 20170925 OTC MONOGRAPH NOT FINAL part333E GoodEarth Distribution Llc BENZALKONIUM CHLORIDE 1.3 mg/1 N 20181231 71746-010_fa77277b-e2a2-4a05-a88c-f64c6b54eeda 71746-010 HUMAN OTC DRUG YUMAKI ORIGINAL MINT TOOTH XYLITOL, GREEN TEA LEAF, ASCORBIC ACID, LEVOMENTHOL, PEPPERMINT, AMINOCAPROIC ACID, WATER PASTE, DENTIFRICE TOPICAL 20171101 UNAPPROVED DRUG OTHER Jeno And Company XYLITOL; GREEN TEA LEAF; ASCORBIC ACID; LEVOMENTHOL; PEPPERMINT OIL; AMINOCAPROIC ACID; WATER .1; .1; .005; .1; .05; .05; 45.15 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 71748-101_6bdbc0d3-1b32-4196-be56-80e28fefe72b 71748-101 HUMAN OTC DRUG JON ARES ACNE CONTROL STEP 1 BENZOYL PEROXIDE CREAM TOPICAL 20170930 OTC MONOGRAPH FINAL part333D DADASHIE ACNE SYSTEM INC BENZOYL PEROXIDE 5 g/100mL N 20181231 71748-102_f076ff26-3551-4af3-82f8-d6c4a9bc3fab 71748-102 HUMAN OTC DRUG JON ARES ACNE CONTROL STEP 2 BENZOYL PEROXIDE CREAM TOPICAL 20170930 OTC MONOGRAPH FINAL part333D DADASHIE ACNE SYSTEM INC BENZOYL PEROXIDE 10 g/100mL N 20181231 71748-103_00e6a450-99fa-4c25-bfae-bf4d6d28b718 71748-103 HUMAN OTC DRUG JON ARES ACNE CONTROL MILD RESORCINIL, SULFUR CREAM TOPICAL 20170930 OTC MONOGRAPH FINAL part333D DADASHIE ACNE SYSTEM INC RESORCINOL; SULFUR 2; 6 g/100mL; g/100mL N 20181231 71749-300_d0b25057-2d45-42b5-97b6-fb4b056e94bf 71749-300 HUMAN OTC DRUG Medt Pad Isopropyl Alcohol SWAB TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part333A Carelife (USA) Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20191231 71750-000_6286e9c4-0798-4e6a-e053-2991aa0a7b9a 71750-000 HUMAN OTC DRUG Eupepsia Thin PAULINIA CUPANA H.B ET K STRIP ORAL 20180111 UNAPPROVED HOMEOPATHIC Aavishkar Oral Strips Pvt. Ltd. PAULLINIA CUPANA SEED 1 [hp_X]/1 N 20191231 71750-001_629787a5-5c2b-8dba-e053-2a91aa0abf93 71750-001 HUMAN OTC DRUG TBX-Free Laburnum anagyroides STRIP ORAL 20180111 UNAPPROVED HOMEOPATHIC Aavishkar Oral Strips Pvt. Ltd. LABURNUM ANAGYROIDES POLLEN 1 [hp_X]/1 N 20191231 71753-1050_adc5da38-5f95-41ee-b009-120920d74c58 71753-1050 HUMAN OTC DRUG Influenzinum Influenzinum (2017-2018) SPRAY ORAL 20171003 UNAPPROVED HOMEOPATHIC Ratis, LLC INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED) 9; 9; 9 [hp_C]/mL; [hp_C]/mL; [hp_C]/mL N 20181231 71753-1052_60c17036-3893-4545-9d60-7d7dd5031dda 71753-1052 HUMAN OTC DRUG Thymuline Thymuline LIQUID ORAL 20171003 UNAPPROVED HOMEOPATHIC Ratis, LLC NONATHYMULIN 9 [hp_C]/mL N 20181231 71753-1054_6f9a3690-88ab-4ee6-a965-cf88dd961b5e 71753-1054 HUMAN OTC DRUG Coxiflu CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE LIQUID ORAL 20171004 UNAPPROVED HOMEOPATHIC Ratis, LLC CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C]/mL N 20181231 71756-8010_59a609e7-4da4-525b-e053-2991aa0a90e2 71756-8010 HUMAN OTC DRUG Tempo Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20100308 OTC MONOGRAPH NOT FINAL part333A Tempo Medical Products ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 71756-8050_59a609e7-4da4-525b-e053-2991aa0a90e2 71756-8050 HUMAN OTC DRUG Tempo BZK Towelette Benzalkonium Chloride CLOTH TOPICAL 20121227 OTC MONOGRAPH NOT FINAL part333A Tempo Medical Products BENZALKONIUM CHLORIDE .13 mg/100mg N 20181231 71756-8090_59a609e7-4da4-525b-e053-2991aa0a90e2 71756-8090 HUMAN OTC DRUG Tempo Sting Relief Pad Benzocaine, Isopropyl Alcohol SWAB TOPICAL 20160930 OTC MONOGRAPH NOT FINAL part348 Tempo Medical Products BENZOCAINE; ISOPROPYL ALCOHOL 6; 70 mg/100mg; mg/100mg N 20181231 71758-106_7835a5ff-93c7-418a-a693-8da3382bd823 71758-106 HUMAN PRESCRIPTION DRUG Noctiva desmopressin acetate SPRAY, METERED NASAL 20171208 NDA NDA201656 Avadel Specialty Pharmaceuticals, LLC DESMOPRESSIN ACETATE .83 ug/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20191231 71758-107_7835a5ff-93c7-418a-a693-8da3382bd823 71758-107 HUMAN PRESCRIPTION DRUG Noctiva desmopressin acetate SPRAY, METERED NASAL 20171208 NDA NDA201656 Avadel Specialty Pharmaceuticals, LLC DESMOPRESSIN ACETATE 1.66 ug/1 Factor VIII Activator [EPC],Increased Coagulation Factor VIII Activity [PE],Increased Coagulation Factor VIII Concentration [PE],Vasopressin Analog [EPC],Vasopressins [Chemical/Ingredient] N 20191231 71759-010_c526b6ec-7ef0-4140-9769-05db336f2c7a 71759-010 HUMAN OTC DRUG NEWSTEM Rx Ceramide Dimethicone, Allantoin CREAM TOPICAL 20170901 OTC MONOGRAPH FINAL part347 Yj Lab Co., Ltd. DIMETHICONE; ALLANTOIN 1; .5 g/100mL; g/100mL N 20181231 71759-020_29a22862-0f30-448f-ad33-1e0b2a723d56 71759-020 HUMAN OTC DRUG NEWSTEM Rx Ceramide Dimethicone, Allantoin LOTION TOPICAL 20170901 OTC MONOGRAPH FINAL part347 Yj Lab Co., Ltd. DIMETHICONE; ALLANTOIN 4; 1 g/200mL; g/200mL N 20181231 71759-030_85e70c1c-f744-4563-b41b-9a435e3a9946 71759-030 HUMAN OTC DRUG NEWSTEM Rx Fractional Dimethicone, Allantoin CREAM TOPICAL 20170901 OTC MONOGRAPH FINAL part347 Yj Lab Co., Ltd. DIMETHICONE; ALLANTOIN 3; .5 g/100mL; g/100mL N 20181231 71759-040_9c2cfb2b-12b0-4dba-afb2-be54ed4970e1 71759-040 HUMAN OTC DRUG NEWSTEM Rx Intensive Allantoin CREAM TOPICAL 20170901 OTC MONOGRAPH FINAL part347 Yj Lab Co., Ltd. ALLANTOIN .075 g/15mL N 20181231 71760-010_6209f631-5ee2-4e33-a499-c939a0bd56f0 71760-010 HUMAN OTC DRUG RED GINSENG VITALIZING HYDROG EL MASK Niacinamide, Adenosine PATCH TOPICAL 20171201 UNAPPROVED DRUG OTHER ENKOREA, Inc. NIACINAMIDE; ADENOSINE .8; .016 g/40g; g/40g N 20191231 71760-020_b043193c-a171-46c1-a3c5-ee80a0e6dc32 71760-020 HUMAN OTC DRUG RED GINSENG BRIGHTENING MASK PACK Niacinamide, Adenosine PATCH TOPICAL 20171201 UNAPPROVED DRUG OTHER ENKOREA, Inc. NIACINAMIDE; ADENOSINE .5; .01 g/25g; g/25g N 20191231 71763-101_3af2c2b3-7293-411a-a44b-e175377fd212 71763-101 HUMAN OTC DRUG Mrs. Meyers Clean Day Hand Sanitizer Basil Scent Alcohol SOLUTION TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part333A The Caldrea Company ALCOHOL .62 mL/mL N 20181231 71763-201_115f300c-311e-407a-974c-2334020412c8 71763-201 HUMAN OTC DRUG Mrs. Meyers Clean Day Hand Sanitizer Lavender Scent Alcohol SOLUTION TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part333A The Caldrea Company ALCOHOL .62 mL/mL N 20181231 71764-100_1eb7bd27-ef41-493c-8fd0-875e72f830cd 71764-100 HUMAN OTC DRUG OPRECARE 07 Sodium Monofluorophosphate PASTE DENTAL 20171012 OTC MONOGRAPH FINAL part355 O'PRECARE SODIUM MONOFLUOROPHOSPHATE .36 g/60g N 20181231 71764-101_ff17f570-3a11-4bea-8566-fab4352f95d2 71764-101 HUMAN OTC DRUG OPRECARE 12 Silicon Dioxide GEL DENTAL 20171012 UNAPPROVED DRUG OTHER O'PRECARE SILICON DIOXIDE 1.71 g/60g N 20181231 71764-102_f12beeb6-783a-4e3a-a566-ac0f855111a3 71764-102 HUMAN OTC DRUG OPRECARE 21 Sodium Monofluorophosphate GEL DENTAL 20171012 OTC MONOGRAPH FINAL part355 O'PRECARE SODIUM MONOFLUOROPHOSPHATE .36 g/60g N 20181231 71764-103_50089863-2c5c-458d-9cad-4426eccf967f 71764-103 HUMAN OTC DRUG OPRECARE 24 Silicon Dioxide GEL DENTAL 20171012 UNAPPROVED DRUG OTHER O'PRECARE SILICON DIOXIDE 1.425 g/50g N 20181231 71764-104_fca63307-fa15-4f20-b6f1-1e9ce6904567 71764-104 HUMAN OTC DRUG OPRECARE 3SET (07,12,21) Sodium Monofluorophosphate, Silicon Dioxide KIT 20171012 UNAPPROVED DRUG OTHER O'PRECARE N 20181231 71766-001_5c08c5c0-cb95-fdfc-e053-2a91aa0a62e5 71766-001 HUMAN OTC DRUG HAND SANITIZER WIPES BENZALKONIUM CHLORIDE GEL TOPICAL 20171010 OTC MONOGRAPH NOT FINAL part333A Hangzhou Linkwell Daily Chemical Co.,Ltd BENZALKONIUM CHLORIDE .13 g/100g N 20181231 71771-001_5a41534d-e77e-e4ac-e053-2a91aa0afa8a 71771-001 HUMAN OTC DRUG Genesis Sensitive Fresh Mint POTASSIUM NITRATE, SODIUM FLUORIDE PASTE DENTAL 20170928 OTC MONOGRAPH NOT FINAL part356 Dr Bobs Inc POTASSIUM NITRATE; SODIUM FLUORIDE 50; 1.5 mg/g; mg/g N 20181231 71772-115_62582a26-8381-0ec4-e053-2991aa0a7a75 71772-115 HUMAN PRESCRIPTION DRUG ASCORBIC ACID ASCORBIC ACID INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20171006 UNAPPROVED DRUG OTHER Fisiopharma SRL ASCORBIC ACID 500 mg/mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20191231 71772-225_618fc2ce-4f75-c571-e053-2a91aa0a1317 71772-225 HUMAN PRESCRIPTION DRUG Vitamin B Complex 100 VITAMIN B COMPLEX INJECTION INTRAMUSCULAR; INTRAVENOUS 20171228 UNAPPROVED DRUG OTHER Fisiopharma SRL THIAMINE HYDROCHLORIDE; DEXPANTHENOL; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM 100; 2; 100; 2; 2 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20181231 71772-301_618fc7f8-21b5-fc7e-e053-2991aa0a827d 71772-301 HUMAN PRESCRIPTION DRUG Dehydrated ALCOHOL SOLUTION INTRASPINAL 20171229 UNAPPROVED DRUG OTHER Fisiopharma SRL ALCOHOL 9.8 mg/mL N 20181231 71772-305_618fc2ce-4f80-c571-e053-2a91aa0a1317 71772-305 HUMAN PRESCRIPTION DRUG Dehydrated ALCOHOL SOLUTION INTRASPINAL 20171229 UNAPPROVED DRUG OTHER Fisiopharma SRL ALCOHOL 9.8 mg/mL N 20181231 71772-486_6280b919-6b05-365e-e053-2991aa0a0b9c 71772-486 HUMAN PRESCRIPTION DRUG Ascorbic Acid ASCORBIC ACID INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20171006 UNAPPROVED DRUG OTHER Fisiopharma SRL ASCORBIC ACID 500 mg/mL Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20191231 71774-0001_5b295a4c-937e-2f40-e053-2991aa0af4f4 71774-0001 HUMAN OTC DRUG PEPTIDE UP VOLUME ESSENCE Niacinamide, Adenosine CREAM TOPICAL 20171010 UNAPPROVED DRUG OTHER FINEPLUS Co.,Ltd. NIACINAMIDE; ADENOSINE 2; .04 g/100mL; g/100mL N 20181231 71780-020_59a68d8b-420f-dfa7-e053-2991aa0a877a 71780-020 HUMAN OTC DRUG LaSpa Mineral Zinc Oxide Sunscreen, 80ml Zinc Oxide CREAM TOPICAL 20171120 OTC MONOGRAPH NOT FINAL part352 The Green Cricket inc ZINC OXIDE 16.96 mg/80mL N 20181231 71781-0001_abc6ac3d-e222-4c98-a9cf-1b6dbce52f4a 71781-0001 HUMAN OTC DRUG Homeoplex A Aralia Quinquefolia, Avena Sativa, Glandula Suprarenalis Suis, Arsenicum Iodatum, Ignatia Amara, Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Zincum Metallicum LIQUID ORAL 20171031 UNAPPROVED HOMEOPATHIC Supplement Clinic, LLC. AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; ARSENIC TRIIODIDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; ZINC 3; 3; 6; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71781-0002_9f23592b-5e83-47ee-b2b5-b2b255938bc1 71781-0002 HUMAN OTC DRUG Homeoplex B Arsenicum Album, Calcarea Carbonica , Ignatia Amara, Kali Carbonicum, Lachesis Mutus, Natrum Muriaticum, Phosphorus, Pulsatilla, Staphysagria LIQUID ORAL 20171031 UNAPPROVED HOMEOPATHIC Supplement Clinic, LLC. ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; SODIUM CHLORIDE; PHOSPHORUS; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED 30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71781-0003_b4f1a644-707b-4b5f-b9ae-355e323183b8 71781-0003 HUMAN OTC DRUG Homeoplex D Glycerinum, Phytolacca Decandra, Taraxacum Officinale, Arsenicum Album, Nitricum Acidum, Nux Vomica, Petroleum, Phosphoricum Acidum, Phosphorus, Acetylsalicylicum Acidum, Glonoinum, Insulinum (Suis), Lithium Carbonicum, Thyroidinum (Suis), Salicylicum Acidum, Adrenocorticotrophin, Cortisone Aceticum, Eugenol, Stearyl Alcohol, Xylitol, Folliculinum, Benzoicum Acidum, Chlorinum, Potassium Sorbate, Sorbitol, Resorcinum, Benzyl Alcohol, Lacticum Acidum, Isopropyl Palmitate, Boricum Acidum, Aceticum Acidum, LIQUID ORAL 20171101 UNAPPROVED HOMEOPATHIC Supplement Clinic, LLC. GLYCERIN; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; ARSENIC TRIOXIDE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORIC ACID; PHOSPHORUS; ASPIRIN; NITROGLYCERIN; INSULIN PORK; LITHIUM CARBONATE; SUS SCROFA THYROID; SALICYLIC ACID; CORTICOTROPIN; CORTISONE ACETATE; EUGENOL; STEARYL ALCOHOL; XYLITOL; ESTRONE; BENZOIC ACID; CHLORINE; POTASSIUM SORBATE; SORBITOL; RESORCINOL; BENZYL ALCOHOL; LACTIC ACID, DL-; ISOPROPYL PALMITATE; BORIC ACID; ACETIC ACID; PHENYLBUTAZONE; PETROLATUM; LEAD 3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71781-0004_51931414-344f-4ad1-856f-72ba06f03102 71781-0004 HUMAN OTC DRUG Homeoplex F Echinacea (Angustifolia), Phytolacca Decandra, Lymph Node (Suis), Conium Maculatum, Ferrum Iodatum, Hepar Sulphuris Calcareum, Kali Muriaticum, Lachesis Mutus, Silicea LIQUID ORAL 20171101 UNAPPROVED HOMEOPATHIC Supplement Clinic, LLC. ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; SUS SCROFA LYMPH; CONIUM MACULATUM FLOWERING TOP; FERROUS IODIDE; CALCIUM SULFIDE; POTASSIUM CHLORIDE; LACHESIS MUTA VENOM; SILICON DIOXIDE 3; 3; 6; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71781-0005_1c6495b2-b51b-4b59-866c-f7dd2feee6db 71781-0005 HUMAN OTC DRUG Homeoplex G Gentiana Lutea, Arsenicum Album, Cinchona Officinalis, Colocynthis, Nux Vomica, Phosphorus, Small Intestine (Suis) LIQUID ORAL 20171101 UNAPPROVED HOMEOPATHIC Supplement Clinic, LLC. GENTIANA LUTEA ROOT; ARSENIC TRIOXIDE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PORK INTESTINE 3; 12; 12; 12; 12; 12; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71781-0006_d33b08fa-aa3b-445d-bd7b-02509835bbec 71781-0006 HUMAN OTC DRUG Homeoplex L Beta Vulgaris, Carduus Marianus, Taraxacum Officinale, Cholesterinum, Fel Tauri, Chelidonium Majus, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus LIQUID ORAL 20171101 UNAPPROVED HOMEOPATHIC Supplement Clinic, LLC. BETA VULGARIS; MILK THISTLE; TARAXACUM OFFICINALE; CHOLESTEROL; BOS TAURUS BILE; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS 3; 3; 3; 6; 6; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71781-0007_8b496fa9-1dd4-4606-becd-4f4414fbd727 71781-0007 HUMAN OTC DRUG Homeoplex P Astragalus Membranaceus, Echinacea (Angustifolia), Scrophularia Nodosa, Tabebuia Impetiginosa, Thyroidinum (Suis), Formicum Acidum, Phosphorus, Silicea, Sulphur, Thuja Occidentalis, Aurum Metallicum LIQUID ORAL 20171101 UNAPPROVED HOMEOPATHIC Supplement Clinic, LLC. ASTRAGALUS PROPINQUUS ROOT; ECHINACEA ANGUSTIFOLIA; SCROPHULARIA NODOSA; TABEBUIA IMPETIGINOSA BARK; SUS SCROFA THYROID; FORMIC ACID; PHOSPHORUS; SILICON DIOXIDE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; GOLD 3; 3; 3; 3; 8; 10; 10; 10; 10; 10; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71782-015_8caf93ba-b91d-4f9e-8fd7-b14e589d52db 71782-015 HUMAN OTC DRUG CANNON BALM OCTINOXATE, OXYBENZONE STICK TOPICAL 20170930 OTC MONOGRAPH FINAL part352 DUKE CANNON SUPPLY CO. OCTINOXATE; OXYBENZONE 1.28; .51 g/17g; g/17g N 20181231 71782-140_26f6a5fa-26d7-4450-8ce9-90334800348d 71782-140 HUMAN OTC DRUG CANNON BALM 140 OCTINOXATE, AVOBENZONE, OCTISALATE, OXYBENZONE STICK TOPICAL 20170930 OTC MONOGRAPH FINAL part352 DUKE CANNON SUPPLY CO. OCTINOXATE; AVOBENZONE; OCTISALATE; OXYBENZONE 1.28; .17; .85; .68 g/17g; g/17g; g/17g; g/17g N 20181231 71786-010_1bc3b06e-91a7-4bea-91e9-7ef9d04260fc 71786-010 HUMAN OTC DRUG Multi Protection UV Bouncer Octinoxate, Octocrylene, Octisalate CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Codecosme International Co., Ltd. OCTINOXATE; OCTOCRYLENE; OCTISALATE 3.5; 2.5; 2.25 g/50mL; g/50mL; g/50mL N 20181231 71786-020_c7838c80-4aee-49c6-a2bc-e9ad3b3bfac0 71786-020 HUMAN OTC DRUG Microfit Cushion 101 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Codecosme International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.15; .8; .48 g/12g; g/12g; g/12g N 20181231 71786-030_41987545-0239-4995-9f18-70877d8b7d2d 71786-030 HUMAN OTC DRUG Microfit Cushion 201 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Codecosme International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.15; .8; .48 g/12g; g/12g; g/12g N 20181231 71786-040_01ced52b-cb17-4b25-84ce-a46c0f7a0688 71786-040 HUMAN OTC DRUG Microfit Cushion 301 Titanium Dioxide, Octinoxate, Octisalate POWDER TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Codecosme International Co., Ltd. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.15; .8; .48 g/12g; g/12g; g/12g N 20181231 71786-050_fb2ee071-a928-4767-bcb3-a145e19bde1e 71786-050 HUMAN OTC DRUG Moonflash Cushion Octinoxate, Titanium Dioxide, Zinc Oxide, Octisalate POWDER TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Codecosme International Co., Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE; OCTISALATE .84; .71; .58; .54 g/12g; g/12g; g/12g; g/12g N 20181231 71788-123_5c3c319f-7eae-6e4a-e053-2a91aa0a7676 71788-123 HUMAN OTC DRUG Protect U Guard 62% Foaming Hand Sanitizer ethyl alcohol LIQUID TOPICAL 20171106 OTC MONOGRAPH NOT FINAL part333E Protect U Guard, LLC ALCOHOL 62 mL/100mL N 20181231 71788-234_5d2cc1f9-3b3e-7385-e053-2a91aa0a1279 71788-234 HUMAN OTC DRUG Protect U Guard Foaming Hand Sanitizer Alcohol Free Benzalkonium Chloride LIQUID TOPICAL 20171106 OTC MONOGRAPH NOT FINAL part333A Protect U Guard, LLC BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 71788-345_5d46f12d-d096-44ac-e053-2a91aa0a0386 71788-345 HUMAN OTC DRUG Protect U Guard Antibacterial Foaming Benzalkonium Chloride LIQUID TOPICAL 20171106 OTC MONOGRAPH NOT FINAL part333A Protect U Guard, LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 71789-400_f38fc920-34e8-47aa-8888-2bdf755381ca 71789-400 HUMAN OTC DRUG MONOGRAM Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170415 OTC MONOGRAPH NOT FINAL part333E US Foods, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 71790-001_5a963df3-4c45-71ce-e053-2a91aa0a1501 71790-001 HUMAN OTC DRUG G9 SKIN White In Creamy Cushion SPF50 PA titanium dioxide POWDER TOPICAL 20170930 OTC MONOGRAPH FINAL part352 COSMELAB Co., Ltd. TITANIUM DIOXIDE 1.96 g/100g N 20181231 71792-101_31b3c3bf-94ed-4e89-90ca-9867a823da62 71792-101 HUMAN OTC DRUG BENZOIL 12HR ACNE TREATMENT BENZOYL PEROXIDE LOTION TOPICAL 20171012 OTC MONOGRAPH FINAL part333D THE SKINCARE COMPANY, INC. BENZOYL PEROXIDE 3 g/100mL N 20181231 71800-003_192a66e4-d73f-42d7-876e-b4ff731c5d02 71800-003 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride TABLET, FILM COATED ORAL 20180116 ANDA ANDA078722 Innovida Pharmaceutique Corporation CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20191231 71800-156_635937aa-4aea-4598-a4fc-a7e440f1d21f 71800-156 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide AEROSOL, SPRAY TOPICAL 20180115 NDA NDA012104 Innovida Pharmaceutique Corporation TRIAMCINOLONE ACETONIDE .147 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20191231 71800-631_60324e6f-72e5-40a1-b534-f28a25e3b518 71800-631 HUMAN PRESCRIPTION DRUG Lidocaine and Tetracaine Lidocaine and Tetracaine CREAM TOPICAL 20170503 NDA AUTHORIZED GENERIC NDA021717 Innovida Pharmaceutique Corporation LIDOCAINE; TETRACAINE 70; 70 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 71801-541_5c4230af-280f-2b73-e053-2991aa0aa4a9 71801-541 HUMAN OTC DRUG OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE CREAM TOPICAL 20170901 OTC MONOGRAPH NOT FINAL part352 PROKPIL SAS OCTISALATE; OCTOCRYLENE; ENSULIZOLE; AVOBENZONE; OCTINOXATE; TITANIUM DIOXIDE 4.5; 2; 2; 2; 6; 2.4 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 71802-856_5b5dffce-d285-c9f7-e053-2a91aa0ae522 71802-856 HUMAN OTC DRUG Evenly Plus Psoriasis care SALICYLIC ACID CREAM TOPICAL 20171012 OTC MONOGRAPH FINAL part358H Evenly Plus, Inc SALICYLIC ACID 20 mg/mL N 20181231 71804-850_5b5a63a3-44bb-55f5-e053-2a91aa0ab15c 71804-850 HUMAN OTC DRUG MD ACNE Customized Hydrating Cleanser SALICYLIC ACID CREAM TOPICAL 20171012 OTC MONOGRAPH FINAL part333D MDalgorithms Inc SALICYLIC ACID 20 mg/mL N 20181231 71804-851_5b5a58c0-a53c-7cd0-e053-2991aa0adff5 71804-851 HUMAN OTC DRUG MD ACNE Customized Hydrating Cleanser SALICYLIC ACID CREAM TOPICAL 20171012 OTC MONOGRAPH FINAL part333D MDalgorithms Inc SALICYLIC ACID 5 mg/mL N 20181231 71804-852_5b5a74a5-b52f-0776-e053-2991aa0ab5b2 71804-852 HUMAN OTC DRUG MD ACNE Customized treatment BENZOYL PEROXIDE CREAM TOPICAL 20171012 OTC MONOGRAPH FINAL part333D MDalgorithms Inc BENZOYL PEROXIDE 50 mg/mL N 20181231 71804-853_5b5a63a3-44c7-55f5-e053-2a91aa0ab15c 71804-853 HUMAN OTC DRUG MD ACNE Customized treatment BENZOYL PEROXIDE CREAM TOPICAL 20171012 OTC MONOGRAPH FINAL part333D MDalgorithms Inc BENZOYL PEROXIDE 25 mg/mL N 20181231 71804-854_5b5a74a5-b53a-0776-e053-2991aa0ab5b2 71804-854 HUMAN OTC DRUG MD ACNE Customized Treatment SALICYLIC ACID CREAM TOPICAL 20171012 OTC MONOGRAPH FINAL part333D MDalgorithms Inc SALICYLIC ACID 20 mg/mL N 20181231 71805-855_5b5dfe5a-a255-06d8-e053-2a91aa0a14bc 71805-855 HUMAN OTC DRUG TerraFreeze Pain Relief MENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20171012 OTC MONOGRAPH NOT FINAL part348 Beyond Derma, LLC MENTHOL; METHYL SALICYLATE; HISTAMINE DIHYDROCHLORIDE 100; 100; .5 mg/g; mg/g; mg/g N 20181231 71810-101_39417963-54c2-4aed-85ff-e1094f2b7eac 71810-101 HUMAN OTC DRUG WORKMANS FRIEND SUPERIOR BARRIER SKIN DIMETHICONE CREAM TOPICAL 20171130 OTC MONOGRAPH FINAL part347 PACKAGING SERVICE CO., INC. DIMETHICONE 1 g/100mL N 20181231 71813-003_60deed9a-5ef6-a854-e053-2991aa0a7eb9 71813-003 HUMAN OTC DRUG ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 03 OCTINOXATE LIQUID TOPICAL 20171024 OTC MONOGRAPH NOT FINAL part352 Make Up For Ever S.A OCTINOXATE; TITANIUM DIOXIDE 67.4; 22.8 mg/mL; mg/mL N 20181231 71813-004_60deed9a-5f05-a854-e053-2991aa0a7eb9 71813-004 HUMAN OTC DRUG ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 04 OCTINOXATE LIQUID TOPICAL 20171024 OTC MONOGRAPH NOT FINAL part352 Make Up For Ever S.A OCTINOXATE; TITANIUM DIOXIDE 67.4; 22.8 mg/mL; mg/mL N 20181231 71813-005_60deed9a-5f14-a854-e053-2991aa0a7eb9 71813-005 HUMAN OTC DRUG ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 05 OCTINOXATE LIQUID TOPICAL 20171024 OTC MONOGRAPH NOT FINAL part352 Make Up For Ever S.A OCTINOXATE; TITANIUM DIOXIDE 67.4; 22.8 mg/mL; mg/mL N 20181231 71813-006_60deed9a-5f23-a854-e053-2991aa0a7eb9 71813-006 HUMAN OTC DRUG ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 06 OCTINOXATE LIQUID TOPICAL 20171024 OTC MONOGRAPH NOT FINAL part352 Make Up For Ever S.A OCTINOXATE; TITANIUM DIOXIDE 67.4; 22.8 mg/mL; mg/mL N 20181231 71813-007_60deed9a-5f32-a854-e053-2991aa0a7eb9 71813-007 HUMAN OTC DRUG ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 07 OCTINOXATE LIQUID TOPICAL 20171024 OTC MONOGRAPH NOT FINAL part352 Make Up For Ever S.A OCTINOXATE; TITANIUM DIOXIDE 67.4; 22.8 mg/mL; mg/mL N 20181231 71813-008_60df03a9-25f0-d5d0-e053-2991aa0a0be0 71813-008 HUMAN OTC DRUG ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 08 OCTINOXATE LIQUID TOPICAL 20171024 OTC MONOGRAPH NOT FINAL part352 Make Up For Ever S.A OCTINOXATE; TITANIUM DIOXIDE 67.4; 22.8 mg/mL; mg/mL N 20181231 71813-009_60df03a9-25ff-d5d0-e053-2991aa0a0be0 71813-009 HUMAN OTC DRUG ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 09 OCTINOXATE LIQUID TOPICAL 20171024 OTC MONOGRAPH NOT FINAL part352 Make Up For Ever S.A OCTINOXATE; TITANIUM DIOXIDE 67.4; 22.8 mg/mL; mg/mL N 20181231 71813-010_60df0f08-6604-6cb5-e053-2a91aa0a7760 71813-010 HUMAN OTC DRUG ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 10 OCTINOXATE LIQUID TOPICAL 20171024 OTC MONOGRAPH NOT FINAL part352 Make Up For Ever S.A OCTINOXATE; TITANIUM DIOXIDE 67.4; 22.8 mg/mL; mg/mL N 20181231 71813-011_60df00a1-4ab9-5cd6-e053-2a91aa0a7f31 71813-011 HUMAN OTC DRUG ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 11 OCTINOXATE LIQUID TOPICAL 20171024 OTC MONOGRAPH NOT FINAL part352 Make Up For Ever S.A OCTINOXATE; TITANIUM DIOXIDE 67.4; 22.8 mg/mL; mg/mL N 20181231 71813-012_60df00a1-4acb-5cd6-e053-2a91aa0a7f31 71813-012 HUMAN OTC DRUG ULTRA HD PERFECTOR BLURRING SKIN TINT WITH SUNSCREEN BROAD SPECTRUM SPF 25 12 OCTINOXATE LIQUID TOPICAL 20171024 OTC MONOGRAPH NOT FINAL part352 Make Up For Ever S.A OCTINOXATE; TITANIUM DIOXIDE 67.4; 22.8 mg/mL; mg/mL N 20181231 71814-410_79c51ea7-91c4-4ffa-be7c-6961d8958fa0 71814-410 HUMAN OTC DRUG Aftertest Pain Relief Benzocaine STICK TOPICAL 20170128 OTC MONOGRAPH FINAL part348 Diabetic Supply of Suncoast, Inc. BENZOCAINE 100 mg/mL N 20181231 71816-0001_5c42f15b-d624-bede-e053-2991aa0a0084 71816-0001 HUMAN OTC DRUG DAYCLING magnesium stearate TABLET VAGINAL 20171024 UNAPPROVED DRUG OTHER ISTK3 MAGNESIUM STEARATE 5 mg/1 N 20181231 71817-858_5c50858a-5f8f-266c-e053-2991aa0af181 71817-858 HUMAN OTC DRUG Cleargenix Advanced Acne Treatment BENZOYL PEROXIDE CREAM TOPICAL 20171024 OTC MONOGRAPH FINAL part333D Push Interactive, LLC BENZOYL PEROXIDE 50 mg/mL N 20181231 71819-007_63ed3699-b3aa-2914-e053-2a91aa0adf6a 71819-007 HUMAN OTC DRUG Zinc Therapy Pyrithione Zinc LIQUID TOPICAL 20180123 OTC MONOGRAPH FINAL part358H D3 Development, Inc. PYRITHIONE ZINC 2 g/100mL N 20191231 71820-0001_5c055e35-2126-65e5-e053-2991aa0ae926 71820-0001 HUMAN OTC DRUG Anti aging hydrogel mask pack glycerin LIQUID TOPICAL 20171021 OTC MONOGRAPH FINAL part347 Mask Factory GLYCERIN 25 g/100g N 20181231 71820-0002_5c324b2e-9d5b-7ece-e053-2991aa0af93f 71820-0002 HUMAN OTC DRUG Moisture hydrogel mask pack glycerin LIQUID TOPICAL 20171021 OTC MONOGRAPH FINAL part347 Mask Factory GLYCERIN 25 g/100g N 20181231 71823-101_e2220990-3d66-4181-a23b-09400ab57b07 71823-101 HUMAN OTC DRUG BLUMINGO ANTI-AGING AM SPF-30 SUNSCREEN HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, OXYBENZONE CREAM TOPICAL 20180113 OTC MONOGRAPH NOT FINAL part352 BLUMINGO LLC HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; OXYBENZONE 15; 10; 5; 3; 1.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20191231 71828-001_5ce721cf-47b9-3cac-e053-2a91aa0adf13 71828-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part333E WAG LABS, INC. ALCOHOL 62 mL/100mL N 20181231 71829-0002_5e766544-48e0-050d-e053-2991aa0aafa7 71829-0002 HUMAN OTC DRUG SpaGelpatch 42degrees celsius CORSET CAPSICUM ANNUUM WHOLE PATCH TOPICAL 20171021 UNAPPROVED DRUG OTHER SENNY STUDIO Co., Ltd CAPSICUM ANNUUM WHOLE .05 g/100g N 20181231 71832-3103_5c08c5c0-cb94-fdfc-e053-2a91aa0a62e5 71832-3103 HUMAN OTC DRUG Human Body Lubricant R170009 Personal Lubricant OIL CUTANEOUS; EXTRACORPOREAL; TOPICAL; VAGINAL 20171021 UNAPPROVED DRUG OTHER ANFEI TECHNOLOGY CO., LTD BUTYLENE GLYCOL 60 g/300mL N 20181231 71838-0001_5be17e26-4eb8-7259-e053-2a91aa0acee2 71838-0001 HUMAN OTC DRUG DOCTOR LEAD M salicylic acid LIQUID TOPICAL 20171024 OTC MONOGRAPH FINAL part358H Kwang Duk Sin Yak Co., Ltd. SALICYLIC ACID 25 g/100mL N 20181231 71838-0003_63b389b9-3f4c-d715-e053-2a91aa0ad08e 71838-0003 HUMAN OTC DRUG DOCTOR LEAD M salicylic acid SHAMPOO TOPICAL 20180126 OTC MONOGRAPH FINAL part358H Kwang Duk Sin Yak Co., Ltd. SALICYLIC ACID .25 g/100mL N 20191231 71847-2215_5cac4425-2fb0-ebfb-e053-2991aa0aba04 71847-2215 HUMAN OTC DRUG Water-based Personal Lubricant, ACVIOO 001 Personal Lubricant OIL CUTANEOUS; EXTRACORPOREAL; TOPICAL; VAGINAL 20171030 UNAPPROVED DRUG OTHER Shenzhen Dikailong Technology Ltd BUTYLENE GLYCOL 48 g/240mL N 20181231 71852-060_5d07f8c1-10cb-4659-e053-2991aa0a399d 71852-060 HUMAN OTC DRUG No BS SPF20 Moisturizer OCTINOXATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part352 Product Management LLC OCTINOXATE; AVOBENZONE; OCTOCRYLENE 55; 30; 20 mg/mL; mg/mL; mg/mL N 20181231 71853-001_5d1f6b57-0878-dd1a-e053-2a91aa0a88fa 71853-001 HUMAN OTC DRUG ElimiShield Clinical Hand Santizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20171102 OTC MONOGRAPH NOT FINAL part333E Bryson Industries Inc. BENZALKONIUM CHLORIDE 13 mg/mL N 20181231 71853-002_60debdc6-0ff4-0da2-e053-2a91aa0a0542 71853-002 HUMAN OTC DRUG ElimiShield Sport Body Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20171102 OTC MONOGRAPH NOT FINAL part333E Bryson Industries Inc. BENZALKONIUM CHLORIDE 13 mg/mL N 20181231 71853-003_6386a9d7-f09a-1b4f-e053-2a91aa0a46f5 71853-003 HUMAN OTC DRUG Weber Rinse Free Skin Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20180122 OTC MONOGRAPH NOT FINAL part333E Bryson Industries Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 71853-004_63868014-c456-3455-e053-2991aa0a7a11 71853-004 HUMAN OTC DRUG ElimiShield Clinical Care Technology Alcohol-Free Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20180122 OTC MONOGRAPH NOT FINAL part333E Bryson Industries Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 71853-005_6386b58a-8bcb-a965-e053-2a91aa0a55f4 71853-005 HUMAN OTC DRUG ElimiShield Sport Alcohol-Free Full Body Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20180122 OTC MONOGRAPH NOT FINAL part333E Bryson Industries Inc BENZALKONIUM CHLORIDE 1.3 mg/mL N 20191231 71856-070_5d07f8c1-10da-4659-e053-2991aa0a399d 71856-070 HUMAN OTC DRUG Arctic Blast Pain Drops MENTHOL CAMPHOR (NATURAL) LIQUID TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part348 Biostar Nutrition Pte. Ltd. MENTHOL; CAMPHOR (NATURAL) 100; 30 mg/mL; mg/mL N 20181231 71857-0001_5dfa41e9-8bed-4b95-e053-2991aa0a9be9 71857-0001 HUMAN OTC DRUG DIAPIA 24K Gold Snail FirmingGel Mask glycerin LIQUID TOPICAL 20171027 OTC MONOGRAPH FINAL part347 BSG H & B Co., Ltd. GLYCERIN 20 g/100g N 20181231 71857-0003_5df90888-1e83-f923-e053-2991aa0ac085 71857-0003 HUMAN OTC DRUG DIAPIA Collagen Goat Milk Ampoule Mask glycerin LIQUID TOPICAL 20171027 OTC MONOGRAPH FINAL part347 BSG H & B Co., Ltd. GLYCERIN 6 g/100g N 20181231 71857-0004_5df75425-20aa-0307-e053-2a91aa0ac706 71857-0004 HUMAN OTC DRUG DIAPIA HA Aqua Shining Mask glycerin LIQUID TOPICAL 20171027 OTC MONOGRAPH FINAL part347 BSG H & B Co., Ltd. GLYCERIN 5 g/100mL N 20181231 71857-0005_5dfacc4f-1175-805b-e053-2991aa0a30a7 71857-0005 HUMAN OTC DRUG DIAPIA 24K Gold SnailGel Eye Patch glycerin LIQUID TOPICAL 20171027 OTC MONOGRAPH FINAL part347 BSG H & B Co., Ltd. GLYCERIN 20 g/100g N 20181231 71862-003_afb49f27-73c5-413b-a7b8-1aff7536a903 71862-003 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20171201 ANDA ANDA202413 Landmark Supply Inc. IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 71862-007_afb49f27-73c5-413b-a7b8-1aff7536a903 71862-007 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20171201 ANDA ANDA202413 Landmark Supply Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 71864-0001_b9198ea8-69ca-4331-8e75-7111d49950ec 71864-0001 HUMAN OTC DRUG Metabolic Support Fucus Vesiculosus, Agnus Castus, Chelidonium Majus, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Phytolacca Decandra, Kali Phosphoricum, Magnesia Phosphorica, Carbo Vegetabilis, Graphites, Calcarea Carbonica, Natrum Phosphoricum, Hypothalamus (Suis), Hypophysis Suis, Placenta Totalis Suis, Thyroidinum (Suis) LIQUID ORAL 20171211 UNAPPROVED HOMEOPATHIC Doctors Studio FUCUS VESICULOSUS; CHASTE TREE; CHELIDONIUM MAJUS; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; DIBASIC POTASSIUM PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ACTIVATED CHARCOAL; GRAPHITE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; BOS TAURUS HYPOTHALAMUS; SUS SCROFA PITUITARY GLAND; SUS SCROFA PLACENTA; THYROID, PORCINE 4; 6; 6; 6; 6; 6; 6; 8; 8; 10; 10; 12; 12; 12; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL N 20181231 71865-0001_5d82945c-72be-3457-e053-2a91aa0a2331 71865-0001 HUMAN OTC DRUG EMMUNE FLOBE EFFECT CUSHION Titanium Dioxide, Zinc Oxide, Ethylhexyl Methoxycinnamate CREAM TOPICAL 20171108 OTC MONOGRAPH NOT FINAL part352 EROM CO., Ltd. TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE 9.7238692; 7.5496; 7 g/100g; g/100g; g/100g N 20181231 71865-0002_60a964f5-a33e-41aa-e053-2991aa0aa4a5 71865-0002 HUMAN OTC DRUG EMMUNE REPAIR Niacinamide, Adenosine CREAM TOPICAL 20171108 UNAPPROVED DRUG OTHER EROM CO., Ltd. ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71865-0003_60aa4a89-2767-4c81-e053-2a91aa0a304f 71865-0003 HUMAN OTC DRUG EMMUNE PERFECT Niacinamide, Adenosine SOLUTION TOPICAL 20171108 UNAPPROVED DRUG OTHER EROM CO., Ltd. ADENOSINE; NIACINAMIDE .04; 2 g/100mL; g/100mL N 20181231 71867-0001_5d678568-6624-0d1b-e053-2991aa0a7335 71867-0001 HUMAN OTC DRUG Rurina Sulfate, Potassium Ion, Chloride Ion LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER TELOM-X GENE Co., Ltd. SULFATE ION; POTASSIUM CATION; CHLORIDE ION 3.6; .25; .11 g/L; g/L; g/L N 20181231 71867-0002_5d67ed46-2614-d5fc-e053-2991aa0acb50 71867-0002 HUMAN OTC DRUG TELOM-X-GENE Sulfate, Potassium Ion, Chloride Ion LIQUID TOPICAL 20170701 UNAPPROVED DRUG OTHER TELOM-X GENE Co., Ltd. SULFATE ION; POTASSIUM CATION; CHLORIDE ION 3.6; .25; .11 g/L; g/L; g/L N 20181231 71868-080_5d58ba36-39e0-418f-e053-2a91aa0a7417 71868-080 HUMAN OTC DRUG Activate Joint and Muscle Relief LIDOCAINE HYDROCHLORIDE, MENTHOL CREAM TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part348 Liberty Health Supply, LLC LIDOCAINE HYDROCHLORIDE; MENTHOL 40; 10 mg/mL; mg/mL N 20181231 71870-001_5efca53c-c4a4-3b8c-e053-2a91aa0a5d75 71870-001 HUMAN OTC DRUG Isopropyl Alcohol 70% 3x3 ISOPROPYL ALCOHOL SWAB TOPICAL 20171116 OTC MONOGRAPH NOT FINAL part333A Winner Medical Co., Ltd. ISOPROPYL ALCOHOL 700 mg/g N 20181231 71870-002_5efcf896-2c76-19bc-e053-2a91aa0ad02b 71870-002 HUMAN OTC DRUG Isopropyl Alcohol 70% 4x4 ISOPROPYL ALCOHOL SWAB TOPICAL 20171116 OTC MONOGRAPH NOT FINAL part333A Winner Medical Co., Ltd. ISOPROPYL ALCOHOL 700 mg/g N 20181231 71874-080_2530d5c6-2e93-4473-987d-70dbc5fc5753 71874-080 HUMAN OTC DRUG DAYCON Antibacterial Foaming Hand So ap Chloroxylenol LIQUID TOPICAL 20110228 OTC MONOGRAPH NOT FINAL part333E Daycon Products Company, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 71875-080_286570db-06d3-4ca1-89cb-4f4770b08e9d 71875-080 HUMAN OTC DRUG EXTENDED CARE Foaming Antimicrobial Handwash Chloroxylenol LIQUID TOPICAL 20080730 OTC MONOGRAPH NOT FINAL part333E TRIPLE A SUPPLIES, INC. CHLOROXYLENOL .003 mg/mL N 20181231 71875-400_d5f94742-ab3f-438f-b25c-cd544512b1e3 71875-400 HUMAN OTC DRUG EXTENDED CARE Antimicrobial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E TRIPLE A SUPPLIES, INC. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 71875-800_2c549ee4-20e0-44f2-885b-fc285a9fd558 71875-800 HUMAN OTC DRUG EXTENDED CARE Foaming Hand Sanitizer ALCOHOL LIQUID TOPICAL 20140515 OTC MONOGRAPH NOT FINAL part333E TRIPLE A SUPPLIES, INC. ALCOHOL .7 mL/mL N 20181231 71876-002_ca842961-ac4d-4447-9f83-21b18e3a47f3 71876-002 HUMAN OTC DRUG Dynamic Broad Spectrum OCTINOXATE and ZINC OXIDE LOTION TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Prescriber's Choice Inc. OCTINOXATE; ZINC OXIDE 75; 48 mg/mL; mg/mL N 20181231 71878-010_c2f4c584-02d9-4f84-a424-c5e307172d54 71878-010 HUMAN OTC DRUG ARMIYOU HYDROGEN TONER Adenosine LIQUID TOPICAL 20171001 UNAPPROVED DRUG OTHER Armiyou ADENOSINE .04 g/120mL N 20181231 71878-020_2711a1b6-1786-4c06-83d7-1deb838de109 71878-020 HUMAN OTC DRUG ARMIYOU HYDROGEN SERUM Adenosine CREAM TOPICAL 20171001 UNAPPROVED DRUG OTHER Armiyou ADENOSINE .01 g/50mL N 20181231 71878-030_44ece81b-29e3-4541-b2fc-cd8eebb2f2a5 71878-030 HUMAN OTC DRUG ARMIYOU HYDROGEN Adenosine EMULSION TOPICAL 20171001 UNAPPROVED DRUG OTHER Armiyou ADENOSINE .04 g/120mL N 20181231 71878-040_e4c1671b-b7d9-4007-9969-a546a6062417 71878-040 HUMAN OTC DRUG ARMIYOU HYDROGEN Niacinamide, Adenosine CREAM TOPICAL 20171001 UNAPPROVED DRUG OTHER Armiyou NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20181231 71882-010_675c2207-faff-43a2-98a9-47a91c6af305 71882-010 HUMAN OTC DRUG EVERYDAY UV PROTECTOR SUN SCREEN Homosalate, Octisalate, Avobenzone, Octocrylene CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Dermal Korea Co., Ltd HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 1.05; .67; .45; .15 g/15g; g/15g; g/15g; g/15g N 20181231 71882-020_494034af-4cff-47c9-a5c5-12d383f28bb3 71882-020 HUMAN OTC DRUG PERFECT 6 in one BB Light Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Dermal Korea Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.21; 1.05; .14 g/15g; g/15g; g/15g N 20181231 71882-030_cd07cd09-767c-4d62-a7ca-901573af5ef5 71882-030 HUMAN OTC DRUG PERFECT 6 in one BB Natural Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Dermal Korea Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.14; 1.05; .14 g/15g; g/15g; g/15g N 20181231 71882-040_a9907b19-5c69-4f2a-afcf-01d57cf3455c 71882-040 HUMAN OTC DRUG PERFECT BB FOR MEN Titanium Dioxide, Octinoxate, Octisalate CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 Dermal Korea Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE 1.38; .75; .3 g/15g; g/15g; g/15g N 20181231 71883-001_ab112d3b-a01d-4270-ac9c-82d419ee577a 71883-001 HUMAN OTC DRUG 21STAY A Thera Sun Block Octinoxate, Zinc Oxide, Titanium Dioxide, Octisalate, Homosalate CREAM TOPICAL 20171121 OTC MONOGRAPH NOT FINAL part352 Oracle Cosmetic Co., Ltd. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE; OCTISALATE; HOMOSALATE 60; 58.2; 54.6; 40; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71884-001_60debb08-ce5e-0da0-e053-2a91aa0ae178 71884-001 HUMAN OTC DRUG My-Shield Topical Antiseptic BENZALKONIUM CHLORIDE LIQUID TOPICAL 20171115 OTC MONOGRAPH NOT FINAL part333A Enviro Specialty Chemicals Inc BENZALKONIUM CHLORIDE 13 mg/mL N 20181231 71884-002_60debdc6-1010-0da2-e053-2a91aa0a0542 71884-002 HUMAN OTC DRUG My-Shield Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20171102 OTC MONOGRAPH NOT FINAL part333E Enviro Specialty Chemicals Inc BENZALKONIUM CHLORIDE 13 mg/mL N 20181231 71885-2103_5e6c1efb-8518-f930-e053-2991aa0af453 71885-2103 HUMAN OTC DRUG Miaojun Medical Cold Paster Cold Paster TAPE CUTANEOUS; EXTRACORPOREAL 20171120 UNAPPROVED DRUG OTHER Ningbo Jigongtang Medicine Technology Co., Ltd. BUTYLENE GLYCOL 48 g/240mL N 20181231 71885-5103_5e804e17-b669-cdd9-e053-2991aa0a285e 71885-5103 HUMAN OTC DRUG Miaojun Heat Paster Heat Paster TAPE CUTANEOUS; EXTRACORPOREAL 20171120 UNAPPROVED DRUG OTHER Ningbo Jigongtang Medicine Technology Co., Ltd. BUTYLENE GLYCOL 48 g/240mL N 20181231 71887-272_61334e9a-50fe-27fa-e053-2a91aa0a1037 71887-272 HUMAN OTC DRUG MIUS Ethyl Alcohol SPRAY TOPICAL 20180117 OTC MONOGRAPH NOT FINAL part333E MIUS Industries Corp ALCOHOL .7 mL/mL N 20181231 71887-272_61490ad7-143e-8c77-e053-2991aa0a1521 71887-272 HUMAN OTC DRUG MIUS Ethyl Alcohol SPRAY TOPICAL 20180117 OTC MONOGRAPH NOT FINAL part333E MIUS Industries Corp. ALCOHOL .7 mL/mL N 20181231 71888-101_60cafbaf-8ec7-46a5-e053-2a91aa0af11f 71888-101 HUMAN OTC DRUG Benzocaine Benzocaine GEL TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Bellus Medical, LLC BENZOCAINE 200 mg/mL N 20181231 71888-102_60cb89f6-e327-0773-e053-2a91aa0a33dd 71888-102 HUMAN OTC DRUG Lidocaine Lidocaine GEL TOPICAL 20170601 OTC MONOGRAPH FINAL part348 Bellus Medical, LLC LIDOCAINE 4 g/100mL N 20181231 71888-103_60cabb5f-606c-7a74-e053-2a91aa0ac024 71888-103 HUMAN OTC DRUG Tetracaine Tetracaine GEL TOPICAL 20170601 OTC MONOGRAPH NOT FINAL part348 Bellus Medical, LLC TETRACAINE HYDROCHLORIDE 20 mg/1000mL N 20181231 71888-104_60530049-b2b9-3ad6-e053-2991aa0aff80 71888-104 HUMAN OTC DRUG Shield Zinc Oxide CREAM TOPICAL 20150501 OTC MONOGRAPH FINAL part352 Bellus Medical, LLC ZINC OXIDE 21 g/100mL N 20181231 71889-350_5e759ff1-82af-f49d-e053-2a91aa0a10ba 71889-350 HUMAN OTC DRUG koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20171118 OTC MONOGRAPH NOT FINAL part352 Kapa'ihi, Inc TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71890-310_5e73baed-6da7-ee96-e053-2991aa0af68c 71890-310 HUMAN OTC DRUG lidoForte Hemorrhoidal LIDOCAINE MINERAL PHENYLEPHRINE HYDROCHLORIDE PETROLATUM CREAM TOPICAL 20171118 OTC MONOGRAPH FINAL part346 Satius Pharmaceuticals, LLC LIDOCAINE; MINERAL OIL; PHENYLEPHRINE HYDROCHLORIDE; PETROLATUM 50; 170; 25; 390 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 71890-320_63eac4a3-37aa-d797-e053-2a91aa0aaa67 71890-320 HUMAN OTC DRUG BET-R-PREP Magnesium Citrate Oral MAGNESIUM CITRATE SOLUTION TOPICAL 20171118 OTC MONOGRAPH NOT FINAL part334 Satius Pharmaceuticals, LLC MAGNESIUM CITRATE 1.745 g/mL N 20191231 71890-330_616803d5-2d92-6558-e053-2a91aa0aa507 71890-330 HUMAN OTC DRUG BET-R-PREP Bisacodyl BISACODYL TABLET TOPICAL 20171118 OTC MONOGRAPH NOT FINAL part334 Satius Pharmaceuticals, LLC BISACODYL 5 mg/1 N 20191231 71891-340_6184042c-45eb-4caa-e053-2a91aa0aee69 71891-340 HUMAN OTC DRUG Source Vital apothecary sunshade SPF 30 TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20171118 OTC MONOGRAPH NOT FINAL part352 Source Vital, LLC TITANIUM DIOXIDE; ZINC OXIDE 60; 60 mg/mL; mg/mL N 20181231 71895-001_bbc031c0-8a40-4ebe-87aa-94c45fd4e260 71895-001 HUMAN OTC DRUG Satohap Pads dl-camphor, l-menthol, methyl salicylate PATCH TOPICAL 19891108 OTC MONOGRAPH NOT FINAL part348 Fuji Seal, Inc. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 5; 4; 8 mg/1; mg/1; mg/1 N 20181231 71895-002_e5e2a5f8-7cb2-4b49-8f5e-7658780dde5e 71895-002 HUMAN OTC DRUG Satogesic dl-camphor, l-menthol, methyl salicylate PATCH TOPICAL 19901203 OTC MONOGRAPH NOT FINAL part348 Fuji Seal, Inc. CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE 5; 4; 8 mg/1; mg/1; mg/1 N 20181231 71895-003_e05b38ff-0640-4cbd-b214-f99da8692dc8 71895-003 HUMAN OTC DRUG Satogesic Hot capsaicin PATCH TOPICAL 20061122 OTC MONOGRAPH NOT FINAL part348 Fuji Seal, Inc. CAPSAICIN .25 mg/1 N 20181231 71896-051_5e062bff-a04e-47fe-b7a5-f4eaf1f50019 71896-051 HUMAN OTC DRUG RENOWN Antimicrobial So ap Chloroxylenol LIQUID TOPICAL 20120801 OTC MONOGRAPH NOT FINAL part333E Interline Brands, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 71896-080_c435f847-92ff-4505-ab1a-2d09755d46dc 71896-080 HUMAN OTC DRUG RENOWN Antibacterial Foam So ap Chloroxylenol LIQUID TOPICAL 20120630 OTC MONOGRAPH NOT FINAL part333E Interline Brands, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 71896-081_921f416f-29cf-470e-9029-82b0fa8cfa4f 71896-081 HUMAN OTC DRUG RENOWN Antibacterial Foam Cleanser Chloroxylenol LIQUID TOPICAL 20120731 OTC MONOGRAPH NOT FINAL part333E Interline Brands, Inc. CHLOROXYLENOL .003 mg/mL N 20181231 71896-400_d25d8865-925d-483f-ade7-5bbe489f6c71 71896-400 HUMAN OTC DRUG RENOWN Antibacterial Plum Handwash Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Interline Brands, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 71897-051_4d4ba8a6-64a0-426e-a185-139b4ad51f4e 71897-051 HUMAN OTC DRUG Reliable Gold Antimicrobial Ltion So ap Chloroxylenol LIQUID TOPICAL 20030131 OTC MONOGRAPH NOT FINAL part333E Veritiv Operating Company CHLOROXYLENOL .003 mg/mL N 20181231 71897-080_4e188b42-6a11-4e63-bb61-9a0342434c8e 71897-080 HUMAN OTC DRUG Reliable Luxury Foam Antimicrobial Handwash Fresh Fruit Scent Chloroxylenol LIQUID TOPICAL 20030115 OTC MONOGRAPH NOT FINAL part333E Veritiv Operating Company CHLOROXYLENOL .003 mg/mL N 20181231 71897-081_d0b65159-c7ad-49b8-a39e-4430e0b0aaec 71897-081 HUMAN OTC DRUG UNISOURCE Foaming Antimicrobial So ap Chloroxylenol LIQUID TOPICAL 20060215 OTC MONOGRAPH NOT FINAL part333E Veritiv Operating Company CHLOROXYLENOL .003 mg/mL N 20181231 71897-082_6bfe8d70-6e00-490c-adeb-13f284dde446 71897-082 HUMAN OTC DRUG UNISOURCE Peach Antimicrobial Foam Chloroxylenol LIQUID TOPICAL 20060630 OTC MONOGRAPH NOT FINAL part333E Veritiv Operating Company CHLOROXYLENOL .003 mg/mL N 20181231 71897-211_61567c51-39cf-4d60-b2a0-e815098098f9 71897-211 HUMAN OTC DRUG UNISOURCE Septophene Antibacterial Ltion Cleanser Chloroxylenol LIQUID TOPICAL 20121130 OTC MONOGRAPH NOT FINAL part333E Veritiv Operating Company CHLOROXYLENOL .003 mg/mL N 20181231 71897-400_5d49f611-9474-4b78-a7dd-54a3dd26084c 71897-400 HUMAN OTC DRUG UNISOURCE Antibacterial Foam Handwash Plum Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Veritiv Operating Company BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 71897-401_86f6a9a3-c227-44f4-aa75-2abf20d933cd 71897-401 HUMAN OTC DRUG Reliable Luxury Foam Antimicrobial Handwash Citrus Floral Scent Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Veritiv Operating Company BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 71897-565_24eb4f8c-1503-4356-abfb-e1d723a31354 71897-565 HUMAN OTC DRUG Reliable E2 Luxury Foam Handwash Chloroxylenol LIQUID TOPICAL 20070630 OTC MONOGRAPH NOT FINAL part333E Veritiv Operating Company CHLOROXYLENOL .01 mg/mL N 20181231 71902-100_bedca3e4-3a46-4d7b-ada3-d9d95fb34848 71902-100 HUMAN OTC DRUG somease Melatonin SPRAY, METERED ORAL 20180115 UNAPPROVED HOMEOPATHIC Biotico Health Canada Limited MELATONIN 1 mg/.2mL N 20181231 71906-051_bee1d31e-e565-4303-b04d-5fd482fc933c 71906-051 HUMAN OTC DRUG BOARDWALK Antibacterial Ltion So ap Chloroxylenol LIQUID TOPICAL 20030315 OTC MONOGRAPH NOT FINAL part333E Essendant Co. CHLOROXYLENOL .003 mg/mL N 20181231 71906-080_e8ed51ab-9d72-47ed-8b92-1441b10aa88a 71906-080 HUMAN OTC DRUG BOARDWALK Antibacterial Foam Handwash Chloroxylenol LIQUID TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part333E Essendant Co. CHLOROXYLENOL .003 mg/mL N 20181231 71906-700_a2b1d7db-9394-4cb0-92ef-accc05a46f24 71906-700 HUMAN OTC DRUG BOARDWALK Hand Sanitizer alcohol GEL TOPICAL 20150830 OTC MONOGRAPH NOT FINAL part333E Essendant Co. ALCOHOL .7 mL/mL N 20181231 71907-051_09730070-a33f-4432-bb72-9c76744079d1 71907-051 HUMAN OTC DRUG SOMERSET Anti-Bac Hand So ap Chloroxylenol LIQUID TOPICAL 20040815 OTC MONOGRAPH NOT FINAL part333E Dade Paper & Bag, LLC CHLOROXYLENOL .003 mg/mL N 20181231 71907-400_669fb5ba-fd1e-4cb1-a3e2-cf18587ce150 71907-400 HUMAN OTC DRUG Victoria Bay Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Dade Paper & Bag, LLC BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 71908-400_3e002b2e-5f1b-410d-821c-6d85cde46966 71908-400 HUMAN OTC DRUG SMART Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Southeastern Paper Group, Inc. BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 71909-0735_5fa65b22-6fec-28f6-e053-2a91aa0a9eec 71909-0735 HUMAN OTC DRUG LOVLUV Vivacity Bright Cushion 21g Titanium Dioxide, OCTINOXATE, ZINC OXIDE, OCTISALATE LIQUID TOPICAL 20180131 20181231 OTC MONOGRAPH NOT FINAL part352 Cnt Dream. Co., Ltd TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE 1.47; .84; 1.05; .273 g/21g; g/21g; g/21g; g/21g N 20181231 71909-0773_5fa19621-8b84-5301-e053-2991aa0aee8f 71909-0773 HUMAN OTC DRUG LOVLUV Vivacity Bright BB Cream Titanium Dioxide, OCTINOXATE, ZINC OXIDE, OCTISALATE CREAM TOPICAL 20180131 20181231 OTC MONOGRAPH NOT FINAL part352 Cnt Dream. Co., Ltd TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE 3.5; 2; 2.5; .65 g/50g; g/50g; g/50g; g/50g N 20181231 71909-0780_5f8d08bd-1407-5416-e053-2a91aa0a3a35 71909-0780 HUMAN OTC DRUG Lovluv Vivacity Bright BB Cream Titanium Dioxide, OCTINOXATE, ZINC OXIDE, OCTISALATE CREAM TOPICAL 20180131 20181231 OTC MONOGRAPH NOT FINAL part352 Cnt Dream. Co., Ltd TITANIUM DIOXIDE; ZINC OXIDE; OCTISALATE; OCTINOXATE 3.5; 2; .65; 2.5 g/50g; g/50g; g/50g; g/50g N 20181231 71909-0797_5fa55646-fe37-6180-e053-2a91aa0a3815 71909-0797 HUMAN OTC DRUG LovLuv Vivacity Bright CC Cream Titanium Dioxide, OCTINOXATE, ZINC OXIDE, OCTISALATE CREAM TOPICAL 20180131 20181231 OTC MONOGRAPH NOT FINAL part352 Cnt Dream. Co., Ltd TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE 3.5; 2; 2.5; .65 g/50g; g/50g; g/50g; g/50g N 20181231 71909-1114_5fb6cd53-766b-0f2e-e053-2a91aa0a621b 71909-1114 HUMAN OTC DRUG LOVLUV Vivacity Bright Cushion 13g Titanium Dioxide, OCTINOXATE, ZINC OXIDE, OCTISALATE LIQUID TOPICAL 20180131 20181231 OTC MONOGRAPH NOT FINAL part352 Cnt Dream. Co., Ltd ZINC OXIDE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .52; .65; .169; .91 g/13g; g/13g; g/13g; g/13g N 20181231 71909-1220_5f7a9b43-c780-3822-e053-2a91aa0a042b 71909-1220 HUMAN OTC DRUG LovLuv M Suit Sun Block TITANIUM DIOXIDE, OCTINOXATE,ZINC OXIDE, OCTISALATE CREAM TOPICAL 20180131 20181231 OTC MONOGRAPH NOT FINAL part352 Cnt Dream. Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 2.5; 2; 2; 1 g/50g; g/50g; g/50g; g/50g N 20181231 71909-1237_5fcb023f-e11b-7483-e053-2991aa0a4745 71909-1237 HUMAN OTC DRUG M Suit Cushion Titanium Dioxide, OCTINOXATE, ZINC OXIDE, OCTISALATE LIQUID TOPICAL 20180131 20181231 OTC MONOGRAPH NOT FINAL part352 Cnt Dream. Co., Ltd OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 1.05; .273; .84; 1.47 g/21g; g/21g; g/21g; g/21g N 20181231 71910-010_595e3b62-56b5-4a6d-b030-cdf1f3a5c15f 71910-010 HUMAN OTC DRUG CELLEANSER Secret Mist Alcohol SPRAY TOPICAL 20171101 OTC MONOGRAPH NOT FINAL part333E Hansol Bio Co.,Ltd ALCOHOL 1.42 g/30mL N 20181231 71911-010_eb9da2c3-8cea-4716-acf3-893070c321dc 71911-010 HUMAN OTC DRUG SPOMETICS GREEN NATURAL SUN Octocrylene, Octinoxate, Octisalate STICK TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part352 Spometics Inc. OCTOCRYLENE; OCTINOXATE; OCTISALATE 1.84; 1.61; 1.03 g/23g; g/23g; g/23g N 20181231 71912-521_36616925-5cd8-4e75-8df7-b78c210c10fa 71912-521 HUMAN OTC DRUG ADVANTAGE CHEMICAL Premium Antibacterial Foaming Hand So ap CHLOROXYLENOL LIQUID TOPICAL 20150415 OTC MONOGRAPH NOT FINAL part333E Advantage Chemical, Inc. CHLOROXYLENOL .005 mg/mL N 20181231 71913-080_85840520-cb75-4e8b-bf2d-9850912cfc5f 71913-080 HUMAN OTC DRUG NICHOLS Luxury Antimicrobial Foam So ap Chloroxylenol LIQUID TOPICAL 20060915 OTC MONOGRAPH NOT FINAL part333E NICHOLS CHLOROXYLENOL .003 mg/mL N 20181231 71915-0001_5f57e8cd-e818-71c4-e053-2991aa0a1803 71915-0001 HUMAN OTC DRUG MEDISKIN INTENSIVE MOISTURE CALMING MASK PACK glycerin LIQUID TOPICAL 20171201 OTC MONOGRAPH FINAL part347 KOCORIUM GLYCERIN 5 g/100g N 20181231 71915-0002_5f5aba85-3f64-4938-e053-2a91aa0acd5f 71915-0002 HUMAN OTC DRUG MEDISKIN INTENSIVE BRIGHTENING MASK PACK glycerin LIQUID TOPICAL 20171201 OTC MONOGRAPH FINAL part347 KOCORIUM GLYCERIN 5 g/100g N 20181231 71915-0003_5f5ac704-57f3-7a41-e053-2a91aa0abab8 71915-0003 HUMAN OTC DRUG MEDISKIN INTENSIVE FIRMING MASK PACK glycerin LIQUID TOPICAL 20171201 OTC MONOGRAPH FINAL part347 KOCORIUM GLYCERIN 5 g/100g N 20181231 71917-001_d60993ab-eae6-4307-9318-69c3449f3a53 71917-001 HUMAN OTC DRUG Cirlutone Camphor OINTMENT TOPICAL 20171206 OTC MONOGRAPH NOT FINAL part348 Herbal Health LLC CAMPHOR (SYNTHETIC) .6 g/100g N 20181231 71919-001_1cf7df8a-7f7a-46ef-aba6-cff5b957b2fd 71919-001 HUMAN OTC DRUG Abies canadensis TSUGA CANADENSIS FLOWER BUD LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TSUGA CANADENSIS FLOWER BUD 30 [hp_C]/mL N 20181231 71919-002_dff72de4-7397-4783-9292-1818d7b5e3c2 71919-002 HUMAN OTC DRUG Abies nigra PICEA MARIANA RESIN LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PICEA MARIANA RESIN 30 [hp_C]/mL N 20181231 71919-004_93443c2a-fbd7-4959-93b0-97edc2ef96d1 71919-004 HUMAN OTC DRUG Absinthium WORMWOOD LIQUID ORAL 20101228 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products WORMWOOD 30 [hp_C]/mL N 20181231 71919-005_463d87e1-f321-4c74-994a-524dc5b47750 71919-005 HUMAN OTC DRUG Acetanilidum ACETANILIDE LIQUID ORAL 20120831 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACETANILIDE 30 [hp_C]/mL N 20181231 71919-006_cb0aad40-15a1-49da-ba57-d9588d5e5ecb 71919-006 HUMAN OTC DRUG Aceticum acidum ACETIC ACID LIQUID ORAL 20091009 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACETIC ACID 30 [hp_C]/mL N 20181231 71919-007_66599db6-af2c-45a8-81df-845ff2cb1274 71919-007 HUMAN OTC DRUG Aconitum ferox ACONITUM FEROX ROOT LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM FEROX ROOT 30 [hp_C]/mL N 20181231 71919-008_0101e72d-ad40-4d20-ae7f-61c662667e1e 71919-008 HUMAN OTC DRUG Aconitum lycoctonum ACONITUM LYCOCTONUM LIQUID ORAL 20111011 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM LYCOCTONUM 30 [hp_C]/mL N 20181231 71919-009_c0d0a805-db69-475d-995a-e5b6f2870ab9 71919-009 HUMAN OTC DRUG Aconitum napellus ACONITUM NAPELLUS LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homepathic Products ACONITUM NAPELLUS 30 [hp_C]/mL N 20181231 71919-010_67ae17f4-1670-4f11-b71c-ed9a29f7a420 71919-010 HUMAN OTC DRUG Aconitum radix ACONITUM NAPELLUS ROOT LIQUID ORAL 20130708 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACONITUM NAPELLUS ROOT 30 [hp_C]/mL N 20181231 71919-011_d9c9de9d-f39c-4de9-b184-b65fc8f3c4e6 71919-011 HUMAN OTC DRUG Actaea spicata ACTAEA SPICATA ROOT LIQUID ORAL 20110129 UNAPPROVED HOMEOPATHIC Washington Homepathic Products ACTAEA SPICATA ROOT 30 [hp_C]/mL N 20181231 71919-012_dbc750fd-14f3-427f-92b6-2f1464a48248 71919-012 HUMAN OTC DRUG Adamas DIAMOND LIQUID ORAL 20140220 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIAMOND 30 [hp_C]/mL N 20181231 71919-013_41fed2ef-14cb-46e5-849f-539d482c6df2 71919-013 HUMAN OTC DRUG Adonis vernalis ADONIS VERNALIS LIQUID ORAL 20111205 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ADONIS VERNALIS 30 [hp_C]/mL N 20181231 71919-014_8a9d0257-784d-49ac-b266-f1432cabd94f 71919-014 HUMAN OTC DRUG Adrenalinum EPINEPHRINE LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EPINEPHRINE 30 [hp_C]/mL N 20181231 71919-015_608ba752-5365-4223-a614-c2551d71db3a 71919-015 HUMAN OTC DRUG Adrenocorticotrophin CORTICOTROPIN LIQUID ORAL 20110102 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CORTICOTROPIN 30 [hp_C]/mL N 20181231 71919-016_fd2fe0bd-e531-4e63-bced-2fcad04dd7c8 71919-016 HUMAN OTC DRUG Aesculus glabra AESCULUS GLABRA NUT LIQUID ORAL 20111205 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AESCULUS GLABRA NUT 30 [hp_C]/mL N 20181231 71919-017_5f0445d5-82a6-4da6-9911-19905ac427a2 71919-017 HUMAN OTC DRUG Aesculus hippocastanum HORSE CHESTNUT LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homepathic Products HORSE CHESTNUT 30 [hp_C]/mL N 20181231 71919-018_7743d703-6f1a-4c8e-b318-262d68996b26 71919-018 HUMAN OTC DRUG Aethusa cynapium AETHUSA CYNAPIUM LIQUID ORAL 20091127 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AETHUSA CYNAPIUM 30 [hp_C]/mL N 20181231 71919-019_f1959492-936c-4be9-9e2a-9b651fe1e555 71919-019 HUMAN OTC DRUG Agaricus muscarius AMANITA MUSCARIA FRUITING BODY LIQUID ORAL 20091022 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMANITA MUSCARIA FRUITING BODY 30 [hp_C]/mL N 20181231 71919-020_8984ad21-1dc3-42a8-968a-e50c11f6b30b 71919-020 HUMAN OTC DRUG Agaricus phalloides AMANITA PHALLOIDES LIQUID ORAL 20110329 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMANITA PHALLOIDES 30 [hp_C]/mL N 20181231 71919-021_cf47b17e-a70c-4309-a492-ece24966dcac 71919-021 HUMAN OTC DRUG Agave americana AGAVE AMERICANA LEAF LIQUID ORAL 20140103 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AGAVE AMERICANA LEAF 30 [hp_C]/mL N 20181231 71919-022_30421536-2a6a-423c-a453-5e6339e2c539 71919-022 HUMAN OTC DRUG Agnus castus CHASTE TREE LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHASTE TREE 30 [hp_C]/mL N 20181231 71919-023_f486d288-6d16-48e3-ad23-8fe344338495 71919-023 HUMAN OTC DRUG Agraphis nutans HYACINTHOIDES NON-SCRIPTA LIQUID ORAL 20120418 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HYACINTHOIDES NON-SCRIPTA 30 [hp_C]/mL N 20181231 71919-024_ea5e5363-6058-4fd4-9140-3f881831a019 71919-024 HUMAN OTC DRUG Agrimonia eupatoria AGRIMONIA EUPATORIA LIQUID ORAL 20150710 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AGRIMONIA EUPATORIA 30 [hp_C]/mL N 20181231 71919-026_51ed154c-e7ca-436d-a39d-7c9708e9b5f5 71919-026 HUMAN OTC DRUG Aletris farinosa ALETRIS FARINOSA ROOT LIQUID ORAL 20100212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALETRIS FARINOSA ROOT 30 [hp_C]/mL N 20181231 71919-027_9fd37a3f-da5e-4390-be59-4166f3d6e5c4 71919-027 HUMAN OTC DRUG Alfalfa ALFALFA LIQUID ORAL 20110517 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALFALFA 30 [hp_C]/mL N 20181231 71919-028_2fcf4e2c-ab52-4a75-821b-83c3801032a7 71919-028 HUMAN OTC DRUG Allium cepa ONION LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ONION 30 [hp_C]/mL N 20181231 71919-029_7b851d2b-76f0-47f0-aaa6-14c343dbb097 71919-029 HUMAN OTC DRUG Allium sativum GARLIC LIQUID ORAL 20100908 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GARLIC 30 [hp_C]/mL N 20181231 71919-030_0fed35ca-4979-446e-ba1c-688e7ab9b41b 71919-030 HUMAN OTC DRUG Alloxanum ALLOXAN LIQUID ORAL 20150804 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALLOXAN 30 [hp_C]/mL N 20181231 71919-031_069b5cb8-0753-45e5-b55a-54d5c9be3e49 71919-031 HUMAN OTC DRUG Aloe socotrina ALOE LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALOE 30 [hp_C]/mL N 20181231 71919-032_596de86b-02d9-4085-aa20-6eb2dd9237a4 71919-032 HUMAN OTC DRUG Althaea officinalis ALTHAEA OFFICINALIS ROOT LIQUID ORAL 20090914 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALTHAEA OFFICINALIS ROOT 30 [hp_C]/mL N 20181231 71919-034_ecf7b735-9258-4039-82d3-ee1ae9c5ba9f 71919-034 HUMAN OTC DRUG Alumina ALUMINUM OXIDE LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALUMINUM OXIDE 30 [hp_C]/mL N 20181231 71919-035_a02c35bc-b6c9-4b76-9088-dc43174845b5 71919-035 HUMAN OTC DRUG Alumina silicata KAOLIN LIQUID ORAL 20120106 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products KAOLIN 30 [hp_C]/mL N 20181231 71919-036_08e269a6-b9be-4895-a45c-41e3e734942e 71919-036 HUMAN OTC DRUG Aluminum metallicum ALUMINUM LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALUMINUM 30 [hp_C]/mL N 20181231 71919-037_97064c44-ef0e-4a4f-95c8-a4627d792752 71919-037 HUMAN OTC DRUG Ambra grisea AMBERGRIS LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMBERGRIS 30 [hp_C]/mL N 20181231 71919-038_70c97c0d-ef74-4a9c-891d-b50c5b45b998 71919-038 HUMAN OTC DRUG Ambrosia artemisiaefolia AMBROSIA ARTEMISIIFOLIA LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMBROSIA ARTEMISIIFOLIA 30 [hp_C]/mL N 20181231 71919-039_4923f2f2-7a5a-466b-ae2d-5aacaf96a90a 71919-039 HUMAN OTC DRUG Ammi visnaga VISNAGA DAUCOIDES FRUIT LIQUID ORAL 20130614 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products VISNAGA DAUCOIDES FRUIT 30 [hp_C]/mL N 20181231 71919-040_aacb3b72-4fd0-40c2-a351-7cc602935493 71919-040 HUMAN OTC DRUG Ammonium benzoicum AMMONIUM BENZOATE LIQUID ORAL 20120926 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM BENZOATE 30 [hp_C]/mL N 20181231 71919-041_a5ad3f1e-3366-4877-9076-d0db597b9619 71919-041 HUMAN OTC DRUG Ammonium bromatum AMMONIUM BROMIDE LIQUID ORAL 20120926 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM BROMIDE 30 [hp_C]/mL N 20181231 71919-042_03e606ca-a392-4667-95af-0dbb050b9e20 71919-042 HUMAN OTC DRUG Ammonium causticum AMMONIA LIQUID ORAL 20110421 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIA 30 [hp_C]/mL N 20181231 71919-043_57388402-cdbf-49ef-bffa-6503bbdea050 71919-043 HUMAN OTC DRUG Ammoniacum gummi AMMONIAC LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIAC 30 [hp_C]/mL N 20181231 71919-044_5b5adfe2-e8b8-4888-9f9f-348aa6db9a8c 71919-044 HUMAN OTC DRUG Ammonium carbonicum AMMONIUM CARBONATE LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM CARBONATE 30 [hp_C]/mL N 20181231 71919-045_4dc0f834-cb40-45a9-8924-583587a16f41 71919-045 HUMAN OTC DRUG Ammonium muriaticum AMMONIUM CHLORIDE LIQUID ORAL 20101122 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM CHLORIDE 30 [hp_C]/mL N 20181231 71919-046_3590dd05-2760-4fd3-a869-cf7fc1df46fe 71919-046 HUMAN OTC DRUG Ammonium phosphoricum AMMONIUM PHOSPHATE, DIBASIC LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM PHOSPHATE, DIBASIC 30 [hp_C]/mL N 20181231 71919-047_c0f02804-0f4b-4972-9bb8-c66cbdfcf062 71919-047 HUMAN OTC DRUG Ammonium picricum AMMONIUM PICRATE LIQUID ORAL 20120404 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM PICRATE 30 [hp_C]/mL N 20181231 71919-048_a92bbdf8-562a-4152-958b-e6597d111d61 71919-048 HUMAN OTC DRUG Ammonium valerianicum AMMONIUM VALERATE LIQUID ORAL 20121129 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMMONIUM VALERATE 30 [hp_C]/mL N 20181231 71919-049_3377bdb3-0521-432c-90f6-18b992875ca5 71919-049 HUMAN OTC DRUG Ampelopsis quinquefolia ADONIS VERNALIS LIQUID ORAL 20131031 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ADONIS VERNALIS 30 [hp_C]/mL N 20181231 71919-050_85266dcb-7da4-434c-9ab7-0aade5ef28bc 71919-050 HUMAN OTC DRUG Amygdalus persica PRUNUS PERSICA FLOWER LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PRUNUS PERSICA FLOWER 30 [hp_C]/mL N 20181231 71919-051_30337440-8d6e-4849-8ef8-4b1c098800a1 71919-051 HUMAN OTC DRUG Amyl nitrosum AMYL NITRITE LIQUID ORAL 20090908 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AMYL NITRITE 30 [hp_C]/mL N 20181231 71919-052_3a126a1c-3682-4288-a819-91ca29a7bcac 71919-052 HUMAN OTC DRUG Anacardium occidentale ANACARDIUM OCCIDENTALE FRUIT LIQUID ORAL 20100312 UNAPPROVED 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Washington Homeopathic Products CHRYSOPOGON ZIZANIOIDES ROOT 30 [hp_C]/mL N 20181231 71919-059_4590cd5b-11f9-4807-83c1-d8ec9a65476a 71919-059 HUMAN OTC DRUG Angustura vera ANGOSTURA BARK LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANGOSTURA BARK 30 [hp_C]/mL N 20181231 71919-060_dfe3efa5-abe2-47fe-b19d-3773621af77a 71919-060 HUMAN OTC DRUG Anthoxanthum odoratum ANTHOXANTHUM ODORATUM LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTHOXANTHUM ODORATUM 30 [hp_C]/mL N 20181231 71919-061_6b3b96f9-3f84-407e-ad95-e5f166917347 71919-061 HUMAN OTC DRUG Anthracinum BACILLUS ANTHRACIS IMMUNOSERUM RABBIT LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 30 [hp_C]/mL N 20181231 71919-062_bff0625a-3bec-4551-a118-0c3416c4ff67 71919-062 HUMAN OTC DRUG Antimonium iodatum ANTIMONY TRIIODIDE LIQUID ORAL 20120518 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANTIMONY 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71919-067_2ef29334-a8fb-4b3b-a826-f3c7a0118e9e 71919-067 HUMAN OTC DRUG Apis venenum purum APIS MELLIFERA VENOM LIQUID ORAL 20100611 UNAPPROVED HOMEOPATHIC Washington Homepathic Products APIS MELLIFERA VENOM 30 [hp_C]/mL N 20181231 71919-068_31f64b67-258e-45e8-9991-6e568b6cb3ff 71919-068 HUMAN OTC DRUG Apium graveolens CELERY SEED LIQUID ORAL 20100708 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CELERY SEED 30 [hp_C]/mL N 20181231 71919-069_b68f956d-8d11-4a0e-aed1-08afe1537a0b 71919-069 HUMAN OTC DRUG Apocynum cannabinum APOCYNUM CANNABINUM ROOT LIQUID ORAL 20101004 UNAPPROVED HOMEOPATHIC Washington Homepathic Products APOCYNUM CANNABINUM ROOT 30 [hp_C]/mL N 20181231 71919-070_f9bb1c18-07e3-4111-a33d-523d49e7684a 71919-070 HUMAN OTC DRUG Aqua marina SODIUM CHLORIDE LIQUID ORAL 20110707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM CHLORIDE 30 [hp_C]/mL N 20181231 71919-071_975be547-337b-4ec3-afbf-ad23fb29de81 71919-071 HUMAN OTC DRUG Aquilegia vulgaris 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71919-081_e7e5f342-b8f0-48bc-8012-117db0c34f9c 71919-081 HUMAN OTC DRUG Arnica montana ARNICA MONTANA LIQUID ORAL 20090828 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARNICA MONTANA 30 [hp_C]/mL N 20181231 71919-082_4e81066b-525a-4a6c-8522-92be2a0f05b8 71919-082 HUMAN OTC DRUG Arnica montana, radix ARNICA MONTANA ROOT LIQUID ORAL 20101011 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARNICA MONTANA ROOT 30 [hp_C]/mL N 20181231 71919-083_9d8283f0-521a-463b-8cce-1748ac9c805d 71919-083 HUMAN OTC DRUG Arsenicum album ARSENIC TRIOXIDE LIQUID ORAL 20090831 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIOXIDE 30 [hp_C]/mL N 20181231 71919-084_0b342ec8-14f4-4534-9f3b-6da01fb6f12d 71919-084 HUMAN OTC DRUG Arsenicum bromatum ARSENIC TRIBROMIDE LIQUID ORAL 20100202 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIBROMIDE 30 [hp_C]/mL N 20181231 71919-085_ce672509-c80c-4f47-a178-831b9fe1cf52 71919-085 HUMAN OTC DRUG Arsenicum iodatum ARSENIC TRIIODIDE LIQUID ORAL 20090102 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRIIODIDE 30 [hp_C]/mL N 20181231 71919-086_be72b316-0145-4247-9e08-4cac701b8c17 71919-086 HUMAN OTC DRUG Arsenicum metallicum ARSENIC LIQUID ORAL 20131205 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC 30 [hp_C]/mL N 20181231 71919-087_9e6b98f8-4598-402d-a6c1-028183f87214 71919-087 HUMAN OTC DRUG Arsenicum sulphuratum flavum ARSENIC TRISULFIDE LIQUID ORAL 20101214 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARSENIC TRISULFIDE 30 [hp_C]/mL N 20181231 71919-088_fa2ab86e-4b33-4d3a-9f08-6e44172aa364 71919-088 HUMAN OTC DRUG Artemisia vulgaris ARTEMISIA VULGARIS ROOT LIQUID ORAL 20110406 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARTEMISIA VULGARIS ROOT 30 [hp_C]/mL N 20181231 71919-089_7fb696c7-f1b4-4fc2-934f-0de7b963bd76 71919-089 HUMAN OTC DRUG Arum triphyllum ARISAEMA TRIPHYLLUM ROOT LIQUID ORAL 20100614 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARISAEMA TRIPHYLLUM ROOT 30 [hp_C]/mL N 20181231 71919-090_47f7ccf2-0064-431a-b01d-9457f0b5f5ec 71919-090 HUMAN OTC DRUG Arundo mauritanica ARUNDO PLINIANA ROOT LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARUNDO PLINIANA ROOT 30 [hp_C]/mL N 20181231 71919-091_5fd95aa7-d20f-4165-aa29-4f017d8317c3 71919-091 HUMAN OTC DRUG Asafoetida FERULA ASSA-FOETIDA RESIN LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERULA ASSA-FOETIDA RESIN 30 [hp_C]/mL N 20181231 71919-092_8f35b82c-1b2b-42ac-8980-b09efcfe7d14 71919-092 HUMAN OTC DRUG Asarum europaeum ASARUM EUROPAEUM LIQUID ORAL 20091120 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASARUM EUROPAEUM 30 [hp_C]/mL N 20181231 71919-093_9d9bce9b-f05e-44a8-a33d-8a9f17865a91 71919-093 HUMAN OTC DRUG Asclepias tuberosa ASCLEPIAS TUBEROSA ROOT LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASCLEPIAS TUBEROSA ROOT 30 [hp_C]/mL N 20181231 71919-094_b7f82d76-f374-41a6-96e7-c14855b57e08 71919-094 HUMAN OTC DRUG Asparagus officinalis ASPARAGUS LIQUID ORAL 20100810 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASPARAGUS 30 [hp_C]/mL N 20181231 71919-096_252f6472-dc02-45ae-9f83-c44c52247bbc 71919-096 HUMAN OTC DRUG Asterias rubens ASTERIAS RUBENS LIQUID ORAL 20100621 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASTERIAS RUBENS 30 [hp_C]/mL N 20181231 71919-097_bce647e1-5911-46f0-bfef-495d55388029 71919-097 HUMAN OTC DRUG Astragalus menziesii ASTRAGALUS NUTTALLII LEAF LIQUID ORAL 20140618 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASTRAGALUS NUTTALLII LEAF 30 [hp_C]/mL N 20181231 71919-098_fd0886b2-041d-4906-9973-9acd2d3081c3 71919-098 HUMAN OTC DRUG Atropinum ATROPINE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ATROPINE 30 [hp_C]/mL N 20181231 71919-099_0a1a66c2-f009-4a38-90a9-b2ef23e0960f 71919-099 HUMAN OTC DRUG Aurum bromatum GOLD TRIBROMIDE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homepathic Products GOLD TRIBROMIDE 30 [hp_C]/mL N 20181231 71919-100_acbcb7c5-d6b6-419d-beb7-ddd9b266f8bd 71919-100 HUMAN OTC DRUG Aurum iodatum GOLD MONOIODIDE LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GOLD MONOIODIDE 30 [hp_C]/mL N 20181231 71919-101_4b14ce09-b251-4120-aec6-794ea5ed4c68 71919-101 HUMAN OTC DRUG Aurum metallicum GOLD LIQUID ORAL 20100212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GOLD 30 [hp_C]/mL N 20181231 71919-102_b571d21b-5361-4740-ae08-0e80ba96b4c9 71919-102 HUMAN OTC DRUG Aurum muriaticum GOLD TRICHLORIDE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GOLD TRICHLORIDE 30 [hp_C]/mL N 20181231 71919-103_982b8c6c-ae6a-4268-9c08-73594bf25190 71919-103 HUMAN OTC DRUG Aurum muriaticum natronatum SODIUM TETRACHLOROAURATE LIQUID ORAL 20100621 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM TETRACHLOROAURATE 30 [hp_C]/mL N 20181231 71919-104_873767f4-27c6-48d5-97b4-8469f18a01d9 71919-104 HUMAN OTC DRUG Aurum sulphuratum GOLD MONOSULFIDE LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GOLD MONOSULFIDE 30 [hp_C]/mL N 20181231 71919-106_84577e19-1cfb-4e80-bb9c-a4399024dc60 71919-106 HUMAN OTC DRUG Azadirachta indica AZADIRACHTA INDICA BARK LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AZADIRACHTA INDICA BARK 30 [hp_C]/mL N 20181231 71919-107_d9a8846f-b85e-444e-bf10-53bf0dbe04db 71919-107 HUMAN OTC DRUG Badiaga SPONGILLA LACUSTRIS LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SPONGILLA LACUSTRIS 30 [hp_C]/mL N 20181231 71919-108_97e53516-1671-4c7b-bb4a-455312389693 71919-108 HUMAN OTC DRUG Balsamum peruvianum BALSAM PERU LIQUID ORAL 20110421 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BALSAM PERU 30 [hp_C]/mL N 20181231 71919-109_acbfb41b-9b84-40ce-b540-2eebcfcc1046 71919-109 HUMAN OTC DRUG Baptisia tinctoria BAPTISIA 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ATROPA BELLADONNA 30 [hp_C]/mL N 20181231 71919-116_90a73437-6ee1-4552-b67e-073e6da85b10 71919-116 HUMAN OTC DRUG Benzinum BENZENE LIQUID ORAL 20100412 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BENZENE 30 [hp_C]/mL N 20181231 71919-117_37616204-bb14-485b-a93c-79a4489a5a42 71919-117 HUMAN OTC DRUG Benzoicum acidum BENZOIC ACID LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BENZOIC ACID 30 [hp_C]/mL N 20181231 71919-118_7983da9f-3af5-42bb-948f-6e12875f476a 71919-118 HUMAN OTC DRUG Benzoinum STYRAX BENZOIN RESIN LIQUID ORAL 20101213 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STYRAX BENZOIN RESIN 30 [hp_C]/mL N 20181231 71919-119_d200be0a-7b88-4f24-8f32-5cd2a23a3810 71919-119 HUMAN OTC DRUG Berberis aquifolium BERBERIS AQUIFOLIUM ROOT BARK LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BERBERIS AQUIFOLIUM ROOT BARK 30 [hp_C]/mL N 20181231 71919-120_b4a99865-bc24-4bd5-9999-c07cb14073ae 71919-120 HUMAN OTC DRUG Berberis vulgaris BERBERIS VULGARIS ROOT BARK LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BERBERIS VULGARIS ROOT BARK 30 [hp_C]/mL N 20181231 71919-121_7a7e04a9-b920-44cd-a9e4-0c7ca5ed1cb0 71919-121 HUMAN OTC DRUG Beryllium metallicum BERYLLIUM LIQUID ORAL 20120611 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BERYLLIUM 30 [hp_C]/mL N 20181231 71919-122_ed214f50-6cb2-4a83-aba0-f41d92d6452a 71919-122 HUMAN OTC DRUG Betula pendula, cortex BETULA PENDULA BARK LIQUID ORAL 20121127 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BETULA PENDULA BARK 30 [hp_C]/mL N 20181231 71919-123_de44081f-c2b2-40c8-b2f2-db01f9b4aea6 71919-123 HUMAN OTC DRUG Bismuthum subnitricum BISMUTH SUBNITRATE LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BISMUTH SUBNITRATE 30 [hp_C]/mL N 20181231 71919-124_2374bf3d-cbbb-4252-b861-3310a5fdc120 71919-124 HUMAN OTC DRUG Bismuthum metallicum BISMUTH LIQUID ORAL 20110126 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BISMUTH 30 [hp_C]/mL N 20181231 71919-125_734f5395-cc03-449d-b7d6-368a96401b8f 71919-125 HUMAN OTC DRUG Blatta orientalis BLATTA ORIENTALIS LIQUID ORAL 20101230 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLATTA ORIENTALIS 30 [hp_C]/mL N 20181231 71919-126_a7156052-13ed-43ce-9389-4853fd32369c 71919-126 HUMAN OTC DRUG Boldo PEUMUS BOLDUS LEAF LIQUID ORAL 20100429 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PEUMUS BOLDUS LEAF 30 [hp_C]/mL N 20181231 71919-127_a40e9115-eae3-4143-b5fc-756b8c609fd9 71919-127 HUMAN OTC DRUG Borax SODIUM BORATE LIQUID ORAL 20100513 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SODIUM BORATE 30 [hp_C]/mL N 20181231 71919-129_17e997ea-066f-4cce-91ab-0a350d843881 71919-129 HUMAN OTC DRUG Bovista LYCOPERDON UTRIFORME FRUITING BODY LIQUID ORAL 20091123 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYCOPERDON UTRIFORME FRUITING BODY 30 [hp_C]/mL N 20181231 71919-130_77b4f32a-6478-4bf1-be81-adee108cbbb3 71919-130 HUMAN OTC DRUG Brassica napus BRASSICA NAPUS SUBSP. NAPUS LIQUID ORAL 20150710 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BRASSICA NAPUS SUBSP. 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ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SELENICEREUS GRANDIFLORUS STEM 30 [hp_C]/mL N 20181231 71919-136_06911d18-d5e6-48f6-8995-a8e73d607958 71919-136 HUMAN OTC DRUG Cadmium bromatum CADMIUM BROMIDE LIQUID ORAL 20150807 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CADMIUM BROMIDE 30 [hp_C]/mL N 20181231 71919-137_e9c3047d-b471-4113-955b-99be62b438d4 71919-137 HUMAN OTC DRUG Cadmium iodatum CADMIUM IODIDE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CADMIUM IODIDE 30 [hp_C]/mL N 20181231 71919-138_ab9ba993-a74c-4ccd-9c35-d653c9a3bf50 71919-138 HUMAN OTC DRUG Cadmium metallicum CADMIUM LIQUID ORAL 20110404 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CADMIUM 30 [hp_C]/mL N 20181231 71919-139_980fe40b-9deb-4039-8881-5b49fb9bf808 71919-139 HUMAN OTC DRUG Cadmium sulphuratum CADMIUM SULFIDE LIQUID ORAL 20100615 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CADMIUM SULFIDE 30 [hp_C]/mL N 20181231 71919-140_db6450a4-a65a-4e86-88be-b4fce3331428 71919-140 HUMAN OTC DRUG Cadmium sulphuricum CADMIUM SULFATE LIQUID ORAL 20101028 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CADMIUM SULFATE 30 [hp_C]/mL N 20181231 71919-141_362c7e08-0b06-42e9-866c-163af7216636 71919-141 HUMAN OTC DRUG Caladium seguinum DIEFFENBACHIA SEGUINE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIEFFENBACHIA SEGUINE 30 [hp_C]/mL N 20181231 71919-142_3def8d64-99c8-4d0a-98bb-0d28d2e050cf 71919-142 HUMAN OTC DRUG Calcarea acetica CALCIUM ACETATE LIQUID ORAL 20140521 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM ACETATE 30 [hp_C]/mL N 20181231 71919-143_28aaf4e6-8339-419a-b33d-7148d6f7a993 71919-143 HUMAN OTC DRUG Calcarea arsenicica CALCIUM ARSENATE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM ARSENATE 30 [hp_C]/mL N 20181231 71919-144_161698a8-258a-4270-8cc2-d3dc9eb5dc32 71919-144 HUMAN OTC DRUG Calcarea carbonica OYSTER SHELL CALCIUM CARBONATE, CRUDE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C]/mL N 20181231 71919-145_b07e4153-6e4d-44a0-87c8-c9a6bc287063 71919-145 HUMAN OTC DRUG Calcarea caustica CALCIUM HYDROXIDE LIQUID ORAL 20100729 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM HYDROXIDE 30 [hp_C]/mL N 20181231 71919-146_9bb583c9-df78-49ee-94d6-1f2e1b0fcee3 71919-146 HUMAN OTC DRUG Calcarea fluorica CALCIUM FLUORIDE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM FLUORIDE 30 [hp_C]/mL N 20181231 71919-147_871ff2ff-46c4-40cc-a222-1cd346d0e077 71919-147 HUMAN OTC DRUG Calcarea hypophosphorosa CALCIUM HYPOPHOSPHITE LIQUID ORAL 20110121 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM HYPOPHOSPHITE 30 [hp_C]/mL N 20181231 71919-148_c8fd9f6d-a316-449d-b466-c8abe9ed1971 71919-148 HUMAN OTC DRUG Calcarea iodata CALCIUM IODIDE LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM IODIDE 30 [hp_C]/mL N 20181231 71919-149_7d7f5f0e-de0e-400a-8578-613527bc39f3 71919-149 HUMAN OTC DRUG Calcarea phosphorica TRIBASIC CALCIUM PHOSPHATE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TRIBASIC CALCIUM PHOSPHATE 30 [hp_C]/mL N 20181231 71919-150_b0ee6f51-b2aa-4b5d-9bac-cb4f736ef0b1 71919-150 HUMAN OTC DRUG Calcarea sulphurica CALCIUM SULFATE ANHYDROUS LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM SULFATE ANHYDROUS 30 [hp_C]/mL N 20181231 71919-151_fd6e10ae-cd87-48b1-804b-b7d42708d3d2 71919-151 HUMAN OTC DRUG Calcarea muriatica CALCIUM CHLORIDE LIQUID ORAL 20120125 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM CHLORIDE 30 [hp_C]/mL N 20181231 71919-152_4f9f1d17-3f76-4e51-adcb-1bd57a50f2a2 71919-152 HUMAN OTC DRUG Calcarea silicata CALCIUM SILICATE LIQUID ORAL 20120713 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM SILICATE 30 [hp_C]/mL N 20181231 71919-154_0ef76391-6823-40e3-9f4b-10c24401d339 71919-154 HUMAN OTC DRUG Calotropis gigantea CALOTROPIS GIGANTEA ROOT LIQUID ORAL 20100324 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALOTROPIS GIGANTEA ROOT 30 [hp_C]/mL N 20181231 71919-155_5ea795f8-cc4a-4094-a312-da8b0a5dea3f 71919-155 HUMAN OTC DRUG Camphora CAMPHOR (NATURAL) LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAMPHOR (NATURAL) 30 [hp_C]/mL N 20181231 71919-156_aca8bf1d-8333-4abc-b090-d22193ac0f51 71919-156 HUMAN OTC DRUG Candida albicans CANDIDA ALBICANS LIQUID ORAL 20100204 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CANDIDA ALBICANS 30 [hp_C]/mL N 20181231 71919-157_3cb9275b-9f31-4d36-971e-c67d79c7295c 71919-157 HUMAN OTC DRUG Candida parapsilosis CANDIDA PARAPSILOSIS LIQUID ORAL 20100204 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CANDIDA PARAPSILOSIS 30 [hp_C]/mL N 20181231 71919-158_eef12bc1-2af4-4369-8ea2-d061d20dfff1 71919-158 HUMAN OTC DRUG Cantharis LYTTA VESICATORIA LIQUID ORAL 20100202 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LYTTA VESICATORIA 30 [hp_C]/mL N 20181231 71919-159_cd8a1490-0e76-4e22-928b-dfbc3caebb6c 71919-159 HUMAN OTC DRUG Capsicum annuum CAPSICUM LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAPSICUM 30 [hp_C]/mL N 20181231 71919-160_543f1a94-daeb-4d1e-98a7-59d3eb093039 71919-160 HUMAN OTC DRUG Carbolicum acidum PHENOL LIQUID ORAL 20100401 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHENOL 30 [hp_C]/mL N 20181231 71919-162_6ecc93bf-259b-4f3a-84c2-8d5aa98f504e 71919-162 HUMAN OTC DRUG Carboneum sulphuratum CARBON DISULFIDE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CARBON DISULFIDE 30 [hp_C]/mL N 20181231 71919-163_ab0d1f5b-7ee4-4e24-a6de-83b94ca1f690 71919-163 HUMAN OTC DRUG Carbo vegetabilis ACTIVATED CHARCOAL LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ACTIVATED CHARCOAL 30 [hp_C]/mL N 20181231 71919-165_e5121758-9dad-41cc-8983-886b838b3b36 71919-165 HUMAN OTC DRUG Carduus benedictus CENTAUREA BENEDICTA LIQUID ORAL 20121121 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CENTAUREA BENEDICTA 30 [hp_C]/mL N 20181231 71919-166_1ca36308-2949-422d-bd01-c315f0dda4b2 71919-166 HUMAN OTC DRUG Carduus marianus MILK THISTLE LIQUID ORAL 20100226 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MILK THISTLE 30 [hp_C]/mL N 20181231 71919-167_e7948d8c-f8a2-45d6-bda3-ce3f8c5167ec 71919-167 HUMAN OTC DRUG Cascarilla CROTON ELUTERIA BARK LIQUID ORAL 20101203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CROTON ELUTERIA BARK 30 [hp_C]/mL N 20181231 71919-168_d25a8b63-3d58-41b7-81af-f40f9f5ae779 71919-168 HUMAN OTC DRUG Castor equi EQUUS CABALLUS LEG CALLOUS LIQUID ORAL 20100514 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EQUUS CABALLUS LEG CALLOUS 30 [hp_C]/mL N 20181231 71919-169_947f38ad-f890-40b5-b0bf-e5197bb6d1f8 71919-169 HUMAN OTC DRUG Castoreum CASTOR FIBER SCENT GLAND SECRETION LIQUID ORAL 20120323 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CASTOR FIBER SCENT GLAND SECRETION 30 [hp_C]/mL N 20181231 71919-170_e231265a-9ec3-47f1-8c2c-158685407158 71919-170 HUMAN OTC DRUG Caulophyllum thalictroides CAULOPHYLLUM THALICTROIDES ROOT LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAULOPHYLLUM THALICTROIDES ROOT 30 [hp_C]/mL N 20181231 71919-171_6d5d31d6-67b6-42e1-9418-35da599d4fcb 71919-171 HUMAN OTC DRUG Causticum CAUSTICUM LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CAUSTICUM 30 [hp_C]/mL N 20181231 71919-172_bd6b8caf-8699-41f7-83f9-92d44050b568 71919-172 HUMAN OTC DRUG Ceanothus americanus CEANOTHUS AMERICANUS LEAF LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CEANOTHUS AMERICANUS LEAF 30 [hp_C]/mL N 20181231 71919-173_befe1552-60e9-4edd-b3ff-e645170b3bbf 71919-173 HUMAN OTC DRUG Cedron SIMABA CEDRON SEED LIQUID ORAL 20100415 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SIMABA CEDRON SEED 30 [hp_C]/mL N 20181231 71919-174_06919c44-861f-485c-a88e-b19a34c0336b 71919-174 HUMAN OTC DRUG Cenchris contortrix AGKISTRODON CONTORTRIX VENOM LIQUID ORAL 20101021 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AGKISTRODON CONTORTRIX VENOM 30 [hp_C]/mL N 20181231 71919-175_c626cfd9-699d-416f-9a68-a39267c71faa 71919-175 HUMAN OTC DRUG Cephalanthus occidentalis CEPHALANTHUS OCCIDENTALIS BARK LIQUID ORAL 20131212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CEPHALANTHUS OCCIDENTALIS BARK 30 [hp_C]/mL N 20181231 71919-176_32187a0c-a09f-4d70-9bc2-69c93a9a47a2 71919-176 HUMAN OTC DRUG Cereus bonplandii HARRISIA POMANENSIS STEM LIQUID ORAL 20101215 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HARRISIA POMANENSIS STEM 30 [hp_C]/mL N 20181231 71919-177_4d4549c2-e8c1-4b02-a29e-0222d505d9a1 71919-177 HUMAN OTC DRUG Chamomilla MATRICARIA CHAMOMILLA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MATRICARIA CHAMOMILLA 30 [hp_C]/mL N 20181231 71919-180_0a392a47-bb1c-42f8-942f-090cac5efcca 71919-180 HUMAN OTC DRUG Chelone glabra CHELONE GLABRA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHELONE GLABRA 30 [hp_C]/mL N 20181231 71919-182_2c853ba3-2a53-4918-93a2-8c955fd9d9b1 71919-182 HUMAN OTC DRUG Chenopodium anthelminticum DYSPHANIA AMBROSIOIDES LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DYSPHANIA AMBROSIOIDES 30 [hp_C]/mL N 20181231 71919-183_5d40f3b3-5e32-45de-9fe7-9955ef44e043 71919-183 HUMAN OTC DRUG Chenopodium vulvaria CHENOPODIUM VULVARIA LIQUID ORAL 20120221 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHENOPODIUM VULVARIA 30 [hp_C]/mL N 20181231 71919-184_c44c6d81-1ba3-4c88-a3e1-a265d1d52a83 71919-184 HUMAN OTC DRUG Chimaphila umbellata CHIMAPHILA UMBELLATA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHIMAPHILA UMBELLATA 30 [hp_C]/mL N 20181231 71919-185_7a407aa2-dd3a-4527-b89e-1de0308734cf 71919-185 HUMAN OTC DRUG Chininum arsenicicum QUININE ARSENATE LIQUID ORAL 20100503 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUININE ARSENATE 30 [hp_C]/mL N 20181231 71919-186_4b90b2e6-13fe-4808-8871-a04aea38c8fe 71919-186 HUMAN OTC DRUG Chininum arsenicosum QUININE ARSENITE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUININE ARSENITE 30 [hp_C]/mL N 20181231 71919-187_93ea8049-1344-42d9-be1c-e6cb9b50443c 71919-187 HUMAN OTC DRUG Chininum purum QUININE LIQUID ORAL 20100204 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUININE 30 [hp_C]/mL N 20181231 71919-188_54e5ef49-41c4-4272-ab41-e1d911abd8aa 71919-188 HUMAN OTC DRUG Chininum salicylicum QUININE SALICYLATE LIQUID ORAL 20100212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUININE SALICYLATE 30 [hp_C]/mL N 20181231 71919-189_fb1c7d85-fee3-4561-a6e4-2819471977cd 71919-189 HUMAN OTC DRUG Chininum sulphuricum QUININE SULFATE LIQUID ORAL 20100302 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUININE SULFATE 30 [hp_C]/mL N 20181231 71919-190_5123a76f-ccef-4c81-99cb-9e1ef1303cc3 71919-190 HUMAN OTC DRUG Chionanthus virginica CHIONANTHUS VIRGINICUS BARK LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHIONANTHUS VIRGINICUS BARK 30 [hp_C]/mL N 20181231 71919-191_d3ed3fe5-8d9f-4beb-832c-dd1319793b4f 71919-191 HUMAN OTC DRUG Chlorinum CHLORINE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHLORINE 30 [hp_C]/mL N 20181231 71919-192_dd99a143-dd26-4480-80df-fdd540457b45 71919-192 HUMAN OTC DRUG Chloroformum CHLOROFORM LIQUID ORAL 20110103 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHLOROFORM 30 [hp_C]/mL N 20181231 71919-193_65daa3ba-40ec-4755-8b38-2f170c7caf62 71919-193 HUMAN OTC DRUG Chlorpromazinum CHLORPROMAZINE LIQUID ORAL 20101007 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHLORPROMAZINE 30 [hp_C]/mL N 20181231 71919-194_b20637e7-250b-4878-a318-1d97a13b52c6 71919-194 HUMAN OTC DRUG Cholesterinum CHOLESTEROL LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHOLESTEROL 30 [hp_C]/mL N 20181231 71919-195_22dceacd-b3cd-40b7-bd4d-f5e0bdb35ba9 71919-195 HUMAN OTC DRUG Chromium oxydatum CHROMIC OXIDE LIQUID ORAL 20110727 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHROMIC OXIDE 30 [hp_C]/mL N 20181231 71919-196_eb531e0a-3b3d-4f24-b96b-abb92f0dd075 71919-196 HUMAN OTC DRUG Chromium sulphuricum CHROMIC SULFATE PENTADECAHYDRATE LIQUID ORAL 20160202 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHROMIC SULFATE PENTADECAHYDRATE 30 [hp_C]/mL N 20181231 71919-197_cff6e0cf-deef-443e-8870-a48458169769 71919-197 HUMAN OTC DRUG Chrysarobinum CHRYSAROBIN LIQUID ORAL 20110307 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHRYSAROBIN 30 [hp_C]/mL N 20181231 71919-198_a5e0941d-f80d-41fb-a5a1-daf819148b54 71919-198 HUMAN OTC DRUG Cicuta virosa CICUTA VIROSA ROOT LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CICUTA VIROSA ROOT 30 [hp_C]/mL N 20181231 71919-199_aeda8a73-641a-4666-bfdf-b98176ff32c2 71919-199 HUMAN OTC DRUG Cimex lectularius CIMEX LECTULARIUS LIQUID ORAL 20130201 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CIMEX LECTULARIUS 30 [hp_C]/mL N 20181231 71919-200_28e5d491-10e5-4dc8-8f9f-e8c3fae3bc3f 71919-200 HUMAN OTC DRUG Cimicifuga racemosa BLACK COHOSH LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLACK COHOSH 30 [hp_C]/mL N 20181231 71919-202_beb5899b-a912-416e-a041-7c1cc6185771 71919-202 HUMAN OTC DRUG Cinchona officinalis CINCHONA OFFICINALIS BARK LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CINCHONA OFFICINALIS BARK 30 [hp_C]/mL N 20181231 71919-203_bbd485b3-903c-4aa7-af24-7098e445d78d 71919-203 HUMAN OTC DRUG Cineraria maritima JACOBAEA MARITIMA LIQUID ORAL 20110207 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products JACOBAEA MARITIMA 30 [hp_C]/mL N 20181231 71919-204_09624ff8-5ffc-4917-8661-ce813e6c9f17 71919-204 HUMAN OTC DRUG Cinnamomum CINNAMON LIQUID ORAL 20110318 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CINNAMON 30 [hp_C]/mL N 20181231 71919-205_1104722c-4927-4da8-ba91-8db711477448 71919-205 HUMAN OTC DRUG Cistus canadensis HELIANTHEMUM CANADENSE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HELIANTHEMUM CANADENSE 30 [hp_C]/mL N 20181231 71919-206_eafb5ace-0f2d-499a-893d-1b5f70c2189b 71919-206 HUMAN OTC DRUG Citrus vulgaris CITRUS AURANTIUM FRUIT RIND LIQUID ORAL 20100322 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CITRUS AURANTIUM FRUIT RIND 30 [hp_C]/mL N 20181231 71919-209_b4207211-a825-4b41-b09e-5566c02783e7 71919-209 HUMAN OTC DRUG Cobaltum metallicum COBALT LIQUID ORAL 20100803 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COBALT 30 [hp_C]/mL N 20181231 71919-210_36857ad7-272a-47f8-9932-b8e586f0ce22 71919-210 HUMAN OTC DRUG Cobaltum nitricum COBALTOUS NITRATE HEXAHYDRATE LIQUID ORAL 20111221 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COBALTOUS NITRATE HEXAHYDRATE 30 [hp_C]/mL N 20181231 71919-211_d8bb28bf-c37b-463a-8971-df1b71cdffae 71919-211 HUMAN OTC DRUG Coccinella septempunctata COCCINELLA SEPTEMPUNCTATA LIQUID ORAL 20100623 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COCCINELLA SEPTEMPUNCTATA 30 [hp_C]/mL N 20181231 71919-212_791f7ad9-b556-46a6-adcc-9c060655420b 71919-212 HUMAN OTC DRUG Cocculus indicus ANAMIRTA COCCULUS SEED LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANAMIRTA COCCULUS SEED 30 [hp_C]/mL N 20181231 71919-213_7f8fc7e5-46b2-4dc7-a34b-337fd480ab90 71919-213 HUMAN OTC DRUG Coccus cacti PROTORTONIA CACTI LIQUID ORAL 20100324 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PROTORTONIA CACTI 30 [hp_C]/mL N 20181231 71919-214_618e41bf-8491-4973-90bf-371a7833bf86 71919-214 HUMAN OTC DRUG Cochlearia armoracia HORSERADISH LIQUID ORAL 20130627 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HORSERADISH 30 [hp_C]/mL N 20181231 71919-216_ed0954ad-2a5d-4bb3-bec5-463af9ab9ec3 71919-216 HUMAN OTC DRUG Coffea cruda ARABICA COFFEE BEAN LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARABICA COFFEE BEAN 30 [hp_C]/mL N 20181231 71919-217_8aaf7446-7466-4635-badf-e7f5fa3d70c6 71919-217 HUMAN OTC DRUG Coffea tosta COFFEA ARABICA SEED, ROASTED LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COFFEA ARABICA SEED, ROASTED 30 [hp_C]/mL N 20181231 71919-218_b190a3c0-4797-4b8f-bc55-99acee719699 71919-218 HUMAN OTC DRUG Colchicum autumnale COLCHICUM AUTUMNALE BULB LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COLCHICUM AUTUMNALE BULB 30 [hp_C]/mL N 20181231 71919-219_804cd1c6-e0cb-4ed2-8aec-37398634187f 71919-219 HUMAN OTC DRUG Colibacillinum cum natrum muriaticum ESCHERICHIA COLI LIQUID ORAL 20121026 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ESCHERICHIA COLI 30 [hp_C]/mL N 20181231 71919-220_5a29e0f4-09bb-42c4-8fbb-1e21c97e3f2d 71919-220 HUMAN OTC DRUG Collinsonia canadensis COLLINSONIA CANADENSIS ROOT LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COLLINSONIA CANADENSIS ROOT 30 [hp_C]/mL N 20181231 71919-221_59a1b6f3-c06d-4d0e-b37f-ba8bf371c21f 71919-221 HUMAN OTC DRUG Colocynthis CITRULLUS COLOCYNTHIS FRUIT PULP LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CITRULLUS COLOCYNTHIS FRUIT PULP 30 [hp_C]/mL N 20181231 71919-224_9046ff09-44c7-44bd-9f5d-757cea492a8a 71919-224 HUMAN OTC DRUG Condurango MARSDENIA CONDURANGO BARK LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MARSDENIA CONDURANGO BARK 30 [hp_C]/mL N 20181231 71919-226_cffbb2e7-52ca-4a2a-8195-7e590c503fca 71919-226 HUMAN OTC DRUG Convallaria majalis 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20150730 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CORIARIA RUSCIFOLIA FRUIT 30 [hp_C]/mL N 20181231 71919-231_a1ede634-4162-4511-9339-49853de3513a 71919-231 HUMAN OTC DRUG Cornus florida CORNUS FLORIDA BARK LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CORNUS FLORIDA BARK 30 [hp_C]/mL N 20181231 71919-232_991eb869-b92d-4028-9980-c71759f44191 71919-232 HUMAN OTC DRUG Cortisone aceticum CORTISONE ACETATE LIQUID ORAL 20100513 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CORTISONE ACETATE 30 [hp_C]/mL N 20181231 71919-233_a2eebeee-bcb4-4ef9-b1e9-0fb721bf9bfd 71919-233 HUMAN OTC DRUG Crocus sativus SAFFRON LIQUID ORAL 20100806 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SAFFRON 30 [hp_C]/mL N 20181231 71919-234_fbba6893-86de-431f-ae33-a20e0a62bf54 71919-234 HUMAN OTC DRUG Crotalus cascavella CROTALUS DURISSUS TERRIFICUS VENOM LIQUID ORAL 20130605 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CROTALUS DURISSUS 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Cupressus lawsoniana CHAMAECYPARIS LAWSONIANA FRUITING TWIG LIQUID ORAL 20120625 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHAMAECYPARIS LAWSONIANA FRUITING TWIG 30 [hp_C]/mL N 20181231 71919-241_75943ac1-0ef7-459b-bcdf-9ca34e0396cd 71919-241 HUMAN OTC DRUG Cuprum aceticum CUPRIC ACETATE LIQUID ORAL 20120904 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CUPRIC ACETATE 30 [hp_C]/mL N 20181231 71919-242_8a5c89a1-d8a2-4988-83ba-3a29cf85fe47 71919-242 HUMAN OTC DRUG Cuprum arsenicosum CUPRIC ARSENITE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CUPRIC ARSENITE 30 [hp_C]/mL N 20181231 71919-243_273cb4ed-86fe-4e13-acc5-70653e7c910a 71919-243 HUMAN OTC DRUG Cuprum metallicum COPPER LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products COPPER 30 [hp_C]/mL N 20181231 71919-244_4835c31c-b4ab-471e-832c-c4cf2ff50373 71919-244 HUMAN OTC DRUG Cuprum oxydatum nigrum CUPRIC OXIDE LIQUID ORAL 20101202 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CUPRIC OXIDE 30 [hp_C]/mL N 20181231 71919-245_1c16e141-eb5e-44a9-a8e2-bbe158a99664 71919-245 HUMAN OTC DRUG Cuprum sulphuricum CUPRIC SULFATE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CUPRIC SULFATE 30 [hp_C]/mL N 20181231 71919-246_f737c3b5-7ab8-4b0d-8e9d-2cf530598578 71919-246 HUMAN OTC DRUG Curare TUBOCURARINE CHLORIDE LIQUID ORAL 20100513 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TUBOCURARINE CHLORIDE 30 [hp_C]/mL N 20181231 71919-247_78c982dc-0b68-4467-aad7-c3827135e2ca 71919-247 HUMAN OTC DRUG Cyclamen europaeum CYCLAMEN PURPURASCENS TUBER LIQUID ORAL 20100419 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CYCLAMEN PURPURASCENS TUBER 30 [hp_C]/mL N 20181231 71919-248_2da69cf0-8576-41f5-92bc-f658dccd6b78 71919-248 HUMAN OTC DRUG Cynara scolymus CYNARA SCOLYMUS LEAF LIQUID ORAL 20160308 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CYNARA SCOLYMUS LEAF 30 [hp_C]/mL N 20181231 71919-249_55e2e1f0-f3a2-493b-adea-44003c6a534c 71919-249 HUMAN OTC DRUG Cypripedium pubescens CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT 30 [hp_C]/mL N 20181231 71919-251_c73a2b17-964c-4f34-a5b5-a1f2de47b2db 71919-251 HUMAN OTC DRUG Damiana TURNERA DIFFUSA LEAFY TWIG LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TURNERA DIFFUSA LEAFY TWIG 30 [hp_C]/mL N 20181231 71919-252_2f2608e7-791e-41f0-9a91-4a84558b475c 71919-252 HUMAN OTC DRUG Daphne indica DAPHNE ODORA BARK LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DAPHNE ODORA BARK 30 [hp_C]/mL N 20181231 71919-253_99d64951-1fcf-4e13-8a05-530c2608cbbd 71919-253 HUMAN OTC DRUG Derris pinnata DALBERGIA PINNATA ROOT LIQUID ORAL 20130523 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DALBERGIA PINNATA ROOT 30 [hp_C]/mL N 20181231 71919-256_658c0c49-6ebe-4421-b682-c75e0d80fec4 71919-256 HUMAN OTC DRUG Digitalis purpurea DIGITALIS LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIGITALIS 30 [hp_C]/mL N 20181231 71919-257_6f343c9b-f7ea-4b84-83c4-194985e6a768 71919-257 HUMAN OTC DRUG Dioscorea villosa DIOSCOREA VILLOSA TUBER LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIOSCOREA VILLOSA TUBER 30 [hp_C]/mL N 20181231 71919-258_cb06e8b6-8e78-496f-85ee-6a15ccaeb49b 71919-258 HUMAN OTC DRUG Dolichos pruriens MUCUNA PRURIENS FRUIT TRICHOME LIQUID ORAL 20110624 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MUCUNA PRURIENS FRUIT TRICHOME 30 [hp_C]/mL N 20181231 71919-259_9ff000e7-a12b-4687-9b4e-d9e7da769a85 71919-259 HUMAN OTC DRUG Drosera rotundifolia DROSERA ROTUNDIFOLIA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DROSERA ROTUNDIFOLIA 30 [hp_C]/mL N 20181231 71919-260_d85a1de5-1c01-4c10-94ad-d6f80b272d39 71919-260 HUMAN OTC DRUG Duboisia myoporoides DUBOISIA MYOPOROIDES LEAF LIQUID ORAL 20150908 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DUBOISIA MYOPOROIDES LEAF 30 [hp_C]/mL N 20181231 71919-261_0797841a-0436-4698-bd48-1c939fff903e 71919-261 HUMAN OTC DRUG Dulcamara SOLANUM DULCAMARA TOP LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SOLANUM DULCAMARA TOP 30 [hp_C]/mL N 20181231 71919-262_5964fa60-b45c-4b37-8018-6f899f1404a4 71919-262 HUMAN OTC DRUG Echinacea angustifolia ECHINACEA ANGUSTIFOLIA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ECHINACEA ANGUSTIFOLIA 30 [hp_C]/mL N 20181231 71919-263_f938da81-0cb4-452a-a2cc-f736a9a297b4 71919-263 HUMAN OTC DRUG Echinacea purpurea ECHINACEA PURPUREA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ECHINACEA PURPUREA 30 [hp_C]/mL N 20181231 71919-264_8530d614-8efc-46d2-8471-192a6b8359be 71919-264 HUMAN OTC DRUG Elaps corallinus MICRURUS CORALLINUS VENOM LIQUID ORAL 20101019 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MICRURUS CORALLINUS VENOM 30 [hp_C]/mL N 20181231 71919-266_9e71417f-c6bf-462e-a1ed-5f5b9fcc4e2d 71919-266 HUMAN OTC DRUG Epigaea repens EPIGAEA REPENS LIQUID ORAL 20100204 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EPIGAEA REPENS 30 [hp_C]/mL N 20181231 71919-267_c4d5790f-0bf9-437b-8e5f-8bd25de79f51 71919-267 HUMAN OTC DRUG Epiphegus virginiana EPIFAGUS VIRGINIANA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EPIFAGUS VIRGINIANA 30 [hp_C]/mL N 20181231 71919-268_a8ed7e75-57bd-4424-afa2-acce352bcf51 71919-268 HUMAN OTC DRUG Equisetum arvense EQUISETUM ARVENSE TOP LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EQUISETUM ARVENSE TOP 30 [hp_C]/mL N 20181231 71919-269_028b7a73-2f4b-4e24-bd0d-5e533ce26bb5 71919-269 HUMAN OTC DRUG Equisetum hyemale EQUISETUM HYEMALE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EQUISETUM HYEMALE 30 [hp_C]/mL N 20181231 71919-270_084a1d87-8293-4ce9-9871-d6ffc431b802 71919-270 HUMAN OTC DRUG Erechtites hieracifolia ERECHTITES HIERACIIFOLIUS LIQUID ORAL 20140122 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ERECHTITES HIERACIIFOLIUS 30 [hp_C]/mL N 20181231 71919-271_3f3c2505-f250-4eb7-844c-1e6aa8cabe93 71919-271 HUMAN OTC DRUG Erigeron canandensis ERIGERON CANADENSIS LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ERIGERON CANADENSIS 30 [hp_C]/mL N 20181231 71919-272_f41a8a76-fec1-4147-8d6c-624838f84030 71919-272 HUMAN OTC DRUG Eriodictyon californicum ERIODICTYON CALIFORNICUM LEAF LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ERIODICTYON CALIFORNICUM LEAF 30 [hp_C]/mL N 20181231 71919-273_e1419f7d-0047-4c2b-b8eb-90ac41c34236 71919-273 HUMAN OTC DRUG Eryngium aquaticum ERYNGIUM YUCCIFOLIUM ROOT LIQUID ORAL 20101029 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ERYNGIUM YUCCIFOLIUM ROOT 30 [hp_C]/mL N 20181231 71919-274_0f144aa7-1c30-4f7a-b830-7f921b304197 71919-274 HUMAN OTC DRUG Eschscholtzia californica ESCHSCHOLZIA CALIFORNICA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ESCHSCHOLZIA CALIFORNICA 30 [hp_C]/mL N 20181231 71919-275_0ab082a6-ac8b-4af8-b116-06f4ad65f1ff 71919-275 HUMAN OTC DRUG Eucalyptus globulus EUCALYPTUS GLOBULUS LEAF LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUCALYPTUS GLOBULUS LEAF 30 [hp_C]/mL N 20181231 71919-276_86203ad7-046c-4721-adbf-0dc1129a7c38 71919-276 HUMAN OTC DRUG Eugenia jambosa SYZYGIUM JAMBOS SEED LIQUID ORAL 20101207 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SYZYGIUM JAMBOS SEED 30 [hp_C]/mL N 20181231 71919-277_5851c78e-61f3-49dc-a938-40e6a0a51fe5 71919-277 HUMAN OTC DRUG Euonymus atropurpureus EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK LIQUID ORAL 20100816 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUONYMUS ATROPURPUREUS BRANCH BARK/ROOT BARK 30 [hp_C]/mL N 20181231 71919-279_1eb1bf7d-52b9-42d3-857c-e50717b9af34 71919-279 HUMAN OTC DRUG Eupatorium purpureum EUTROCHIUM PURPUREUM ROOT LIQUID ORAL 20111025 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUTROCHIUM PURPUREUM ROOT 30 [hp_C]/mL N 20181231 71919-281_5a0713c5-ac01-41ac-b968-b492bc5c2cd4 71919-281 HUMAN OTC DRUG Euphorbium officinarum EUPHORBIA RESINIFERA RESIN LIQUID ORAL 20100517 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPHORBIA RESINIFERA RESIN 30 [hp_C]/mL N 20181231 71919-282_202cc5e4-9aa3-4655-818d-efe60863fe5b 71919-282 HUMAN OTC DRUG Euphrasia officinalis EUPHRASIA STRICTA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products EUPHRASIA STRICTA 30 [hp_C]/mL N 20181231 71919-283_97562634-75c9-4d3d-a2ef-03ca4f61a0ea 71919-283 HUMAN OTC DRUG Fagopyrum esculentum FAGOPYRUM ESCULENTUM LIQUID ORAL 20101029 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FAGOPYRUM ESCULENTUM 30 [hp_C]/mL N 20191231 71919-284_480dc682-b4a8-4cc9-9721-a8ab5b1cf89d 71919-284 HUMAN OTC DRUG Fagus sylvatica FAGUS SYLVATICA NUT LIQUID ORAL 20131212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FAGUS SYLVATICA NUT 30 [hp_C]/mL N 20191231 71919-285_30611030-5e66-47f4-9809-aaa048747bcf 71919-285 HUMAN OTC DRUG Fel tauri BOS TAURUS BILE LIQUID ORAL 20100629 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BOS TAURUS BILE 30 [hp_C]/mL N 20191231 71919-286_5a1a3c7e-f6bb-4d69-a0ca-7656e8e1dbe5 71919-286 HUMAN OTC DRUG Ferrum arsenicicum FERROUS ARSENATE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERROUS ARSENATE 30 [hp_C]/mL N 20191231 71919-287_3bd37d47-fd78-4d0b-9f9e-6cf1cbc6abaf 71919-287 HUMAN OTC DRUG Ferrum carbonicum FERROUS CARBONATE LIQUID ORAL 20110511 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERROUS CARBONATE 30 [hp_C]/mL N 20191231 71919-288_c7df4ff4-daed-490b-9477-7410ed60b821 71919-288 HUMAN OTC DRUG Ferrum iodatum FERROUS IODIDE LIQUID ORAL 20100729 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERROUS IODIDE 30 [hp_C]/mL N 20191231 71919-289_b3595ae5-5206-4640-b29c-9502593a57cf 71919-289 HUMAN OTC DRUG Ferrum metallicum IRON LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IRON 30 [hp_C]/mL N 20191231 71919-290_023095b0-fa8f-476a-95e6-278e5227466f 71919-290 HUMAN OTC DRUG Ferrum muriaticum FERRIC CHLORIDE HEXAHYDRATE LIQUID ORAL 20100419 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERRIC CHLORIDE HEXAHYDRATE 30 [hp_C]/mL N 20191231 71919-291_60a3cb2d-eba2-4a37-affb-ed8921679427 71919-291 HUMAN OTC DRUG Ferrum phosphoricum FERROSOFERRIC PHOSPHATE LIQUID ORAL 20100319 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERROSOFERRIC PHOSPHATE 30 [hp_C]/mL N 20191231 71919-292_1395e556-0777-4b38-a7a2-fe20153580b7 71919-292 HUMAN OTC DRUG Ferrum picricum FERRIC PICRATE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERRIC PICRATE 30 [hp_C]/mL N 20191231 71919-293_a6047e03-e836-4fcf-9bd3-cace629f7e45 71919-293 HUMAN OTC DRUG Ferrum sulphuricum FERROUS SULFATE LIQUID ORAL 20110614 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FERROUS SULFATE 30 [hp_C]/mL N 20191231 71919-294_aef6bd6a-a84f-46ce-9d87-f65a2523c20f 71919-294 HUMAN OTC DRUG Ficus religiosa FICUS RELIGIOSA LEAFY TWIG LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FICUS RELIGIOSA LEAFY TWIG 30 [hp_C]/mL N 20191231 71919-295_b83a5c62-5f64-4bd8-aaa5-b77d0b4f5445 71919-295 HUMAN OTC DRUG Filix mas DRYOPTERIS FILIX-MAS ROOT LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DRYOPTERIS FILIX-MAS ROOT 30 [hp_C]/mL N 20191231 71919-296_b5caec2d-2b76-4cb6-86b2-2bfa773e1a8d 71919-296 HUMAN OTC DRUG Foeniculum vulgare FENNEL SEED LIQUID ORAL 20131212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FENNEL SEED 30 [hp_C]/mL N 20191231 71919-297_f00b92aa-e028-48a2-a142-a46af4803b32 71919-297 HUMAN OTC DRUG Folliculinum ESTRONE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ESTRONE 30 [hp_C]/mL N 20191231 71919-298_12d8ae2f-de63-4760-a342-19ecf373b877 71919-298 HUMAN OTC DRUG Formalinum FORMALDEHYDE LIQUID ORAL 20101208 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FORMALDEHYDE 30 [hp_C]/mL N 20191231 71919-299_17fdfc76-0fd3-4010-85bd-3b978337ed03 71919-299 HUMAN OTC DRUG Formica rufa FORMICA RUFA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FORMICA RUFA 30 [hp_C]/mL N 20191231 71919-300_6e0d5caf-5824-48a0-b822-a7ce9c036346 71919-300 HUMAN OTC DRUG Formicum acidum FORMIC ACID LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FORMIC ACID 30 [hp_C]/mL N 20191231 71919-301_242924e0-da7a-4749-853b-7f71c18b606e 71919-301 HUMAN OTC DRUG Fragaria vesca ALPINE STRAWBERRY LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ALPINE STRAWBERRY 30 [hp_C]/mL N 20191231 71919-302_bdb884fc-26ec-4e8a-901c-ee96453757ec 71919-302 HUMAN OTC DRUG Franciscea uniflora BRUNFELSIA UNIFLORA ROOT LIQUID ORAL 20160208 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BRUNFELSIA UNIFLORA ROOT 30 [hp_C]/mL N 20191231 71919-303_9845ed56-88f0-4dad-ac1f-724c8b1fa1d4 71919-303 HUMAN OTC DRUG Fraxinus americana FRAXINUS AMERICANA BARK LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FRAXINUS AMERICANA BARK 30 [hp_C]/mL N 20191231 71919-304_a662b17c-a9af-4806-932d-c8db7455630f 71919-304 HUMAN OTC DRUG Fucus vesiculosus FUCUS VESICULOSUS LIQUID ORAL 20130925 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FUCUS VESICULOSUS 30 [hp_C]/mL N 20191231 71919-305_7cc936cd-a810-4e64-adad-aa594ae0bb16 71919-305 HUMAN OTC DRUG Galanthus nivalis GALANTHUS NIVALIS LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GALANTHUS NIVALIS 30 [hp_C]/mL N 20191231 71919-306_90560c28-1b85-4238-a95a-81cbc6985b62 71919-306 HUMAN OTC DRUG Galega officinalis GALEGA OFFICINALIS LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GALEGA OFFICINALIS 30 [hp_C]/mL N 20191231 71919-307_aa85ed43-087d-4d8f-b272-28b34cde26cb 71919-307 HUMAN OTC DRUG Galium aparine GALIUM APARINE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GALIUM APARINE 30 [hp_C]/mL N 20191231 71919-308_680f7a1b-d1b4-4f0a-966d-d608c5383b53 71919-308 HUMAN OTC DRUG Gallicum acidum GALLIC ACID MONOHYDRATE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GALLIC ACID MONOHYDRATE 30 [hp_C]/mL N 20191231 71919-310_eed9d42c-fb68-4feb-bede-4f9c79386bb5 71919-310 HUMAN OTC DRUG Gambogia GAMBOGE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GAMBOGE 30 [hp_C]/mL N 20191231 71919-311_9a9d730d-e077-4d17-9e8f-41a58d5999d7 71919-311 HUMAN OTC DRUG Gaultheria procumbens GAULTHERIA PROCUMBENS TOP LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products GAULTHERIA PROCUMBENS TOP 30 [hp_C]/mL N 20191231 71919-313_18ee0dec-bcff-4bf9-8355-df4ed3c91f50 71919-313 HUMAN OTC DRUG Gentiana cruciata GENTIANA CRUCIATA ROOT LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic 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71919-336_bf36633d-aad7-4152-8604-d1d9c0ce23ce 71919-336 HUMAN OTC DRUG Helix tosta ESCARGOT SHELL, COOKED LIQUID ORAL 20121129 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ESCARGOT SHELL, COOKED 30 [hp_C]/mL N 20191231 71919-337_8317d4d4-6625-45c2-b62e-099e1e6ce28b 71919-337 HUMAN OTC DRUG Helleborus niger HELLEBORUS NIGER ROOT LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HELLEBORUS NIGER ROOT 30 [hp_C]/mL N 20191231 71919-338_e1df6e46-11bb-490f-a70e-4e93ca6dcf9e 71919-338 HUMAN OTC DRUG Heloderma HELODERMA HORRIDUM VENOM LIQUID ORAL 20111116 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HELODERMA HORRIDUM VENOM 30 [hp_C]/mL N 20191231 71919-339_bb19b777-bb8f-4949-b254-9ddbbf828883 71919-339 HUMAN OTC DRUG Helonias dioica CHAMAELIRIUM LUTEUM ROOT LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CHAMAELIRIUM LUTEUM ROOT 30 [hp_C]/mL N 20191231 71919-341_8246a660-cc12-4c27-a591-a380cc9abb9c 71919-341 HUMAN OTC 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OBTUSA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANEMONE HEPATICA VAR. 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71919-357_55a65b2d-19d4-4c42-b708-5ef2e68acadc 71919-357 HUMAN OTC DRUG Ignatia amara STRYCHNOS IGNATII SEED LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STRYCHNOS IGNATII SEED 30 [hp_C]/mL N 20191231 71919-358_0807dfcb-e8ef-4839-a77e-cb7c2335bafd 71919-358 HUMAN OTC DRUG Ilex aquifolium ILEX AQUIFOLIUM FRUITING TOP LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ILEX AQUIFOLIUM FRUITING TOP 30 [hp_C]/mL N 20191231 71919-359_3b8cc981-9d19-468f-87e4-2df834eacc16 71919-359 HUMAN OTC DRUG Ilex paraguariensis ILEX PARAGUARIENSIS LEAF LIQUID ORAL 20140127 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ILEX PARAGUARIENSIS LEAF 30 [hp_C]/mL N 20191231 71919-360_ad83fc80-2a53-4a6e-b866-d4a38b7abbdc 71919-360 HUMAN OTC DRUG Illicium anisatum STAR ANISE LIQUID ORAL 20100204 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STAR ANISE 30 [hp_C]/mL N 20191231 71919-361_545259cb-4d88-4bfa-bd22-48a799e9705f 71919-361 HUMAN OTC 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71919-367_85f45b65-2a52-497b-ae39-dfe033999e77 71919-367 HUMAN OTC DRUG Iridium metallicum IRIDIUM LIQUID ORAL 20100326 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IRIDIUM 30 [hp_C]/mL N 20191231 71919-368_6e7f476c-219c-4204-81c0-d14363b1c3ff 71919-368 HUMAN OTC DRUG Iris tenax IRIS TENAX LIQUID ORAL 20140320 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IRIS TENAX 30 [hp_C]/mL N 20191231 71919-369_5ac4c385-9862-44f1-8016-e201a87e6dfc 71919-369 HUMAN OTC DRUG Iris versicolor IRIS VERSICOLOR ROOT LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products IRIS VERSICOLOR ROOT 30 [hp_C]/mL N 20191231 71919-370_93cf95d3-30b6-4946-83be-954f216eb6a3 71919-370 HUMAN OTC DRUG Jacaranda caroba JACARANDA CAROBA FLOWER LIQUID ORAL 20150529 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products JACARANDA CAROBA FLOWER 30 [hp_C]/mL N 20191231 71919-371_630500d5-fc63-42e3-b860-7cc26e2b1cd6 71919-371 HUMAN OTC DRUG Jalapa IPOMOEA PURGA ROOT LIQUID ORAL 20150527 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[hp_C]/mL N 20191231 71919-380_870981bb-5c9a-4282-94fc-be761e0ae423 71919-380 HUMAN OTC DRUG Kali carbonicum POTASSIUM CARBONATE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM CARBONATE 30 [hp_C]/mL N 20191231 71919-381_3226a948-3ed0-4cc2-be55-40bc94ef54a6 71919-381 HUMAN OTC DRUG Kali chlor POTASSIUM CHLORATE LIQUID ORAL 20101021 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM CHLORATE 30 [hp_C]/mL N 20191231 71919-382_a625d47e-604a-4652-ac33-a6497621bd6e 71919-382 HUMAN OTC DRUG Kali cyanatum POTASSIUM CYANIDE LIQUID ORAL 20150725 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM CYANIDE 30 [hp_C]/mL N 20191231 71919-383_a62f01fb-6f6f-44b3-bf79-276fc29f85f7 71919-383 HUMAN OTC DRUG Kali iodatum POTASSIUM IODIDE LIQUID ORAL 20101021 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM IODIDE 30 [hp_C]/mL N 20191231 71919-384_b850d1a5-08a6-4ed7-9eaa-1cccf954e19a 71919-384 HUMAN OTC DRUG Kali muriaticum POTASSIUM CHLORIDE LIQUID ORAL 20101021 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM CHLORIDE 30 [hp_C]/mL N 20191231 71919-385_13241513-a171-4fb9-a00a-921d93cc69b3 71919-385 HUMAN OTC DRUG Kali nitricum POTASSIUM NITRATE LIQUID ORAL 20101029 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM NITRATE 30 [hp_C]/mL N 20191231 71919-386_2154ce85-3938-4c4e-b782-f621f7ea6c72 71919-386 HUMAN OTC DRUG Kali permanganicum POTASSIUM PERMANGANATE LIQUID ORAL 20150727 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POTASSIUM PERMANGANATE 30 [hp_C]/mL N 20191231 71919-387_d18fcebb-eda9-4648-9900-1125a361dfb1 71919-387 HUMAN OTC DRUG Kali phosphoricum DIBASIC POTASSIUM PHOSPHATE LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DIBASIC POTASSIUM PHOSPHATE 30 [hp_C]/mL N 20191231 71919-388_bb478532-fb7e-492b-b180-569b6f44fa77 71919-388 HUMAN OTC DRUG Kali silicatum POTASSIUM SILICATE LIQUID ORAL 20150727 UNAPPROVED HOMEOPATHIC 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71919-393_2a3a887e-03ad-455d-9658-2abe28645e01 71919-393 HUMAN OTC DRUG Kousso HAGENIA ABYSSINICA FLOWER LIQUID ORAL 20100315 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products HAGENIA ABYSSINICA FLOWER 30 [hp_C]/mL N 20191231 71919-394_aba88429-77d4-4c97-a714-f44d8c1c4d5c 71919-394 HUMAN OTC DRUG Kreosotum WOOD CREOSOTE LIQUID ORAL 20100212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products WOOD CREOSOTE 30 [hp_C]/mL N 20191231 71919-396_5f8eeb7a-8213-4282-abf0-ebba2c78a6d0 71919-396 HUMAN OTC DRUG Lac caninum CANIS LUPUS FAMILIARIS MILK LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CANIS LUPUS FAMILIARIS MILK 30 [hp_C]/mL N 20191231 71919-397_65b518bc-8b18-4dfa-a163-e35c8f8b8f81 71919-397 HUMAN OTC DRUG Lac defloratum SKIM MILK LIQUID ORAL 20101202 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SKIM MILK 30 [hp_C]/mL N 20191231 71919-398_06356a3b-93de-4204-aef6-5b78f2e03259 71919-398 HUMAN OTC DRUG Lac felinum FELIS CATUS MILK LIQUID ORAL 20110707 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FELIS CATUS MILK 30 [hp_C]/mL N 20191231 71919-399_2a7de268-80a3-40fb-b7b4-fcdcb6a5c4d7 71919-399 HUMAN OTC DRUG Lachesis mutus LACHESIS MUTA VENOM LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACHESIS MUTA VENOM 30 [hp_C]/mL N 20191231 71919-400_4a92b9bf-c250-4e92-a784-d2b023640322 71919-400 HUMAN OTC DRUG Lachnanthes tinctoria LACHNANTHES CAROLINIANA LIQUID ORAL 20100803 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACHNANTHES CAROLINIANA 30 [hp_C]/mL N 20191231 71919-401_05b4957b-0612-4acd-9c69-c5fd3fce9997 71919-401 HUMAN OTC DRUG Lacticum acidum LACTIC ACID, DL- LIQUID ORAL 20100324 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACTIC ACID, DL- 30 [hp_C]/mL N 20191231 71919-402_f60b6c8c-969c-4542-8656-58084372b090 71919-402 HUMAN OTC DRUG Lactuca virosa LACTUCA VIROSA LIQUID ORAL 20100521 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LACTUCA VIROSA 30 [hp_C]/mL N 20191231 71919-403_d016099f-383c-4186-b4a2-8690bf82ad9c 71919-403 HUMAN OTC DRUG Lapis albus CALCIUM HEXAFLUOROSILICATE LIQUID ORAL 20100514 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CALCIUM HEXAFLUOROSILICATE 30 [hp_C]/mL N 20191231 71919-404_2353d130-48b5-4500-a8ff-3912bc93f4e1 71919-404 HUMAN OTC DRUG Lappa major ARCTIUM LAPPA ROOT LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ARCTIUM LAPPA ROOT 30 [hp_C]/mL N 20191231 71919-405_cbeb53b3-b4ea-4b3d-b425-28e15b392720 71919-405 HUMAN OTC DRUG Lathyrus sativas LATHYRUS SATIVAS SEED LIQUID ORAL 20101119 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LATHYRUS SATIVAS SEED 30 [hp_C]/mL N 20191231 71919-406_d0b3a20a-81f0-478d-9c18-b11f8a2497f6 71919-406 HUMAN OTC DRUG Latrodectus mactans LATRODECTUS MACTANS LIQUID ORAL 20100412 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LATRODECTUS MACTANS 30 [hp_C]/mL N 20191231 71919-407_fe34f46e-1618-4fbb-a4fe-f4c9985de470 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N 20191231 71919-443_f6b99acd-c2a6-410c-98c0-f74f80fba96a 71919-443 HUMAN OTC DRUG Mangifera indica MANGIFERA INDICA BARK LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MANGIFERA INDICA BARK 30 [hp_C]/mL N 20191231 71919-444_f4feeac7-7f4f-47ee-800f-7312a0853291 71919-444 HUMAN OTC DRUG Marrubium vulgare MARRUBIUM VULGARE LIQUID ORAL 20140221 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MARRUBIUM VULGARE 30 [hp_C]/mL N 20191231 71919-445_143d9e1b-5a58-45cb-859c-51087ffe8db9 71919-445 HUMAN OTC DRUG Medusa PHYSALIA PHYSALIS LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHYSALIA PHYSALIS 30 [hp_C]/mL N 20191231 71919-446_88843957-6927-45f6-959e-50ee3f11faa1 71919-446 HUMAN OTC DRUG Melilotus alba MELILOTUS ALBUS TOP LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MELILOTUS ALBUS TOP 30 [hp_C]/mL N 20191231 71919-447_10d9b676-3f10-4639-bfb5-420033c64b4f 71919-447 HUMAN OTC DRUG Melilotus officinalis MELILOTUS OFFICINALIS TOP LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MELILOTUS OFFICINALIS TOP 30 [hp_C]/mL N 20191231 71919-448_28f91b31-ab41-4877-90ab-2930d1828b4e 71919-448 HUMAN OTC DRUG Melissa officinalis MELISSA OFFICINALIS LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MELISSA OFFICINALIS 30 [hp_C]/mL N 20191231 71919-449_59ca41de-986f-40ec-a966-69a48de896a2 71919-449 HUMAN OTC DRUG Mentha piperita MENTHA PIPERITA LIQUID ORAL 20110302 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MENTHA PIPERITA 30 [hp_C]/mL N 20191231 71919-450_f3a75f8f-9bb9-4668-89e6-bdebd4d804de 71919-450 HUMAN OTC DRUG Mentha viridis MENTHA SPICATA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products MENTHA SPICATA 30 [hp_C]/mL N 20191231 71919-451_a64ae41e-eae7-4d44-86fa-cb1deba3021e 71919-451 HUMAN OTC DRUG Mentholum MENTHOL, UNSPECIFIED FORM LIQUID ORAL 20110802 UNAPPROVED HOMEOPATHIC Washington 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71919-491_2032d164-ac6c-49df-a1de-3b56879b321f 71919-491 HUMAN OTC DRUG Nicotinum NICOTINE LIQUID ORAL 20100324 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NICOTINE 30 [hp_C]/mL N 20191231 71919-492_adcd4a43-b4f7-4148-bfb8-0629747a912f 71919-492 HUMAN OTC DRUG Nitricum acidum NITRIC ACID LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NITRIC ACID 30 [hp_C]/mL N 20191231 71919-493_3a98caac-0348-4e3e-ac9a-adb66a537575 71919-493 HUMAN OTC DRUG Nitrogenum oxygenatum NITROUS OXIDE LIQUID ORAL 20110524 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products NITROUS OXIDE 30 [hp_C]/mL N 20191231 71919-494_996ba0d5-0bf7-48e4-b5ed-9134d7420b16 71919-494 HUMAN OTC DRUG Nitromuriaticum acidum AQUA REGIA LIQUID ORAL 20100921 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products AQUA REGIA 30 [hp_C]/mL N 20191231 71919-495_db87e801-fdba-4219-8c41-4ef810328b84 71919-495 HUMAN OTC DRUG Nuphar luteum NUPHAR LUTEA ROOT LIQUID ORAL 20100514 UNAPPROVED HOMEOPATHIC 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CAPITIS LIQUID ORAL 20121121 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PEDICULUS HUMANUS VAR. 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Petroselinum sativum PETROSELINUM CRISPUM LIQUID ORAL 20090325 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PETROSELINUM CRISPUM 30 [hp_C]/mL N 20191231 71919-530_5974856d-4c39-4970-b3bc-5b2cf4cd50b0 71919-530 HUMAN OTC DRUG Phosphoricum acidum PHOSPHORIC ACID LIQUID ORAL 20100112 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHOSPHORIC ACID 30 [hp_C]/mL N 20191231 71919-531_a077d107-0b5d-4f6a-9060-4aa102429cbd 71919-531 HUMAN OTC DRUG Phosphorus PHOSPHORUS LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHOSPHORUS 30 [hp_C]/mL N 20191231 71919-532_67bca8ff-7133-463e-a27b-397126c1f246 71919-532 HUMAN OTC DRUG Physostigma venenosum PHYSOSTIGMA VENENOSUM SEED LIQUID ORAL 20100316 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PHYSOSTIGMA VENENOSUM SEED 30 [hp_C]/mL N 20191231 71919-533_9086f3fa-5a64-4bc1-a334-6595097bc0dd 71919-533 HUMAN OTC DRUG Phytolacca decandra PHYTOLACCA AMERICANA ROOT LIQUID ORAL 20100203 UNAPPROVED 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muriaticum PLATINIC CHLORIDE HEXAHYDRATE LIQUID ORAL 20090505 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PLATINIC CHLORIDE HEXAHYDRATE 30 [hp_C]/mL N 20191231 71919-547_226d6828-19b2-4177-9ca0-7092a703cdd5 71919-547 HUMAN OTC DRUG Plumbum aceticum LEAD ACETATE ANHYDROUS LIQUID ORAL 20100826 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEAD ACETATE ANHYDROUS 30 [hp_C]/mL N 20191231 71919-548_fec5fe2d-5b1c-4b76-956b-cfb8f76c107d 71919-548 HUMAN OTC DRUG Plumbum iodatum LEAD IODIDE LIQUID ORAL 20101011 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEAD IODIDE 30 [hp_C]/mL N 20191231 71919-549_53d73219-490c-46f8-bc5f-92b532ff859d 71919-549 HUMAN OTC DRUG Plumbum metallicum LEAD LIQUID ORAL 20100226 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LEAD 30 [hp_C]/mL N 20191231 71919-550_8039977a-505f-4381-a4a4-6715fff0c5b4 71919-550 HUMAN OTC DRUG Podophyllinum PODOPHYLLUM RESIN LIQUID ORAL 20100324 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PODOPHYLLUM RESIN 30 [hp_C]/mL N 20191231 71919-551_3c7f17e6-6586-4535-bcf8-1f4fd5777b44 71919-551 HUMAN OTC DRUG Podophyllum peltatum PODOPHYLLUM LIQUID ORAL 20100630 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PODOPHYLLUM 30 [hp_C]/mL N 20191231 71919-552_867ad869-3bd3-4a1f-99fd-0a77a4b68f79 71919-552 HUMAN OTC DRUG Polyporus officinalis LARICIFOMES OFFICINALIS FRUITING BODY LIQUID ORAL 20110325 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products LARICIFOMES OFFICINALIS FRUITING BODY 30 [hp_C]/mL N 20191231 71919-553_ffa48020-0eea-4794-9edd-d2fa72d98234 71919-553 HUMAN OTC DRUG Polyporus pinicola FOMITOPSIS PINICOLA FRUITING BODY LIQUID ORAL 20091006 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FOMITOPSIS PINICOLA FRUITING BODY 30 [hp_C]/mL N 20191231 71919-554_cd468e4b-dd84-41f1-b86a-6f61f25dd434 71919-554 HUMAN OTC DRUG Populus candicans POPULUS BALSAMIFERA LEAF BUD LIQUID ORAL 20100317 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POPULUS 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71919-559_f0d7a9c4-50bd-4ae5-90f2-241d82e2028f 71919-559 HUMAN OTC DRUG Prunus virginiana PRUNUS SEROTINA BARK LIQUID ORAL 20101019 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PRUNUS SEROTINA BARK 30 [hp_C]/mL N 20191231 71919-560_9cb51a61-ea57-4458-a46c-b23cda2c19af 71919-560 HUMAN OTC DRUG Ptelea trifoliata PTELEA TRIFOLIATA BARK LIQUID ORAL 20090929 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PTELEA TRIFOLIATA BARK 30 [hp_C]/mL N 20191231 71919-561_167ac65a-1670-4727-bc38-0503f87317eb 71919-561 HUMAN OTC DRUG Pulex irritans PULEX IRRITANS LIQUID ORAL 20100303 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PULEX IRRITANS 30 [hp_C]/mL N 20191231 71919-562_2331fed8-2855-4f8e-82da-742254eede9a 71919-562 HUMAN OTC DRUG Pulsatilla ANEMONE PULSATILLA LIQUID ORAL 20091110 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANEMONE PULSATILLA 30 [hp_C]/mL N 20191231 71919-563_fd738e5c-9c0b-4e0a-8052-a848b42f69a6 71919-563 HUMAN OTC DRUG Pulsatilla nuttalliana ANEMONE PATENS LIQUID ORAL 20101208 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANEMONE PATENS 30 [hp_C]/mL N 20191231 71919-564_25ad5971-a001-4c91-9183-df58cb29efbf 71919-564 HUMAN OTC DRUG Pyrethrum parthenium TANACETUM PARTHENIUM LIQUID ORAL 20091106 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TANACETUM PARTHENIUM 30 [hp_C]/mL N 20191231 71919-565_68d72a36-8918-4b00-ac74-8918f94f83e9 71919-565 HUMAN OTC DRUG Pyrogenium RANCID BEEF LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RANCID BEEF 30 [hp_C]/mL N 20191231 71919-566_199189d7-dfa5-4480-91f1-f228d5313562 71919-566 HUMAN OTC DRUG Quassia amara QUASSIA AMARA WOOD LIQUID ORAL 20090225 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUASSIA AMARA WOOD 30 [hp_C]/mL N 20191231 71919-567_ab2709de-8a28-4e40-be38-804679309099 71919-567 HUMAN OTC DRUG Quebracho ASPIDOSPERMA QUEBRACHO-BLANCO BARK LIQUID ORAL 20091008 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ASPIDOSPERMA QUEBRACHO-BLANCO BARK 30 [hp_C]/mL N 20191231 71919-568_8675e086-7091-4618-a4d6-a6049afad9ed 71919-568 HUMAN OTC DRUG Quercus glandium spiritus QUERCUS ROBUR NUT LIQUID ORAL 20091008 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUERCUS ROBUR NUT 30 [hp_C]/mL N 20191231 71919-569_f9574b3e-8a94-4437-a550-aff0b4a3c644 71919-569 HUMAN OTC DRUG Quercus robur QUERCUS ROBUR TWIG BARK LIQUID ORAL 20091106 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUERCUS ROBUR TWIG BARK 30 [hp_C]/mL N 20191231 71919-570_3e3e1ca5-631e-4ac8-9b0c-055935f30aba 71919-570 HUMAN OTC DRUG Quillaja saponaria QUILLAJA SAPONARIA BARK LIQUID ORAL 20090731 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products QUILLAJA SAPONARIA BARK 30 [hp_C]/mL N 20191231 71919-571_b7867853-4341-4f03-bf47-7e78964fa1ae 71919-571 HUMAN OTC DRUG Radium bromatum RADIUM BROMIDE LIQUID ORAL 20091117 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RADIUM BROMIDE 30 [hp_C]/mL N 20191231 71919-572_5d3bdb35-6495-47be-8a35-51f88d5cf863 71919-572 HUMAN OTC DRUG Ranunculus bulbosus RANUNCULUS BULBOSUS LIQUID ORAL 20090929 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RANUNCULUS BULBOSUS 30 [hp_C]/mL N 20191231 71919-573_8ad758b9-bbf0-4a32-a013-d096d7d7b968 71919-573 HUMAN OTC DRUG Ranunculus sceleratus RANUNCULUS SCELERATUS LIQUID ORAL 20091208 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RANUNCULUS SCELERATUS 30 [hp_C]/mL N 20191231 71919-574_bfe968b9-a9bb-416e-ac60-0e6de4ec50ae 71919-574 HUMAN OTC DRUG Raphanus sativus RADISH LIQUID ORAL 20091013 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RADISH 30 [hp_C]/mL N 20191231 71919-575_fa67cef3-ce04-4b27-905c-0d56d2ff783d 71919-575 HUMAN OTC DRUG Ratanhia KRAMERIA LAPPACEA ROOT LIQUID ORAL 20091028 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products KRAMERIA LAPPACEA ROOT 30 [hp_C]/mL N 20191231 71919-576_600671fe-779f-4e00-848e-759958468ec3 71919-576 HUMAN OTC DRUG Rauwolfia serpentina 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TOXICODENDRON PUBESCENS LEAF 30 [hp_C]/mL N 20191231 71919-585_dd220426-0e36-4278-87e8-fed539cbab20 71919-585 HUMAN OTC DRUG Rhus venenata TOXICODENDRON VERNIX LEAFY TWIG LIQUID ORAL 20100305 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TOXICODENDRON VERNIX LEAFY TWIG 30 [hp_C]/mL N 20191231 71919-586_a64fcc63-34ee-4963-b318-83878ca0f222 71919-586 HUMAN OTC DRUG Ricinus communis RICINUS COMMUNIS SEED LIQUID ORAL 20110211 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RICINUS COMMUNIS SEED 30 [hp_C]/mL N 20191231 71919-587_211f2bd6-df3b-4ea2-8338-103256513c0b 71919-587 HUMAN OTC DRUG Robinia pseudoacacia ROBINIA PSEUDOACACIA BARK LIQUID ORAL 20100120 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ROBINIA PSEUDOACACIA BARK 30 [hp_C]/mL N 20191231 71919-588_8c3926af-9615-4101-b8a2-461e7e7d4c44 71919-588 HUMAN OTC DRUG Rosa canina ROSA CANINA FRUIT LIQUID ORAL 20140722 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ROSA CANINA FRUIT 30 [hp_C]/mL N 20191231 71919-591_a191c2b1-f0df-45ae-927f-67d62ab05e26 71919-591 HUMAN OTC DRUG Rubia tinctorum RUBIA TINCTORUM ROOT LIQUID ORAL 20090114 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RUBIA TINCTORUM ROOT 30 [hp_C]/mL N 20191231 71919-592_f371544a-9b6d-4815-96a8-1e95e688f4b4 71919-592 HUMAN OTC DRUG Rumex acetosa RUMEX ACETOSA LEAF LIQUID ORAL 20110218 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RUMEX ACETOSA LEAF 30 [hp_C]/mL N 20191231 71919-593_e7755d9f-50ab-400c-bb44-26ec63f8901f 71919-593 HUMAN OTC DRUG Rumex crispus RUMEX CRISPUS ROOT LIQUID ORAL 20100514 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RUMEX CRISPUS ROOT 30 [hp_C]/mL N 20191231 71919-594_00576048-1e0b-4516-a996-fd6e83283d06 71919-594 HUMAN OTC DRUG Rumex obtusifolius RUMEX OBTUSIFOLIUS ROOT LIQUID ORAL 20111006 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products RUMEX OBTUSIFOLIUS ROOT 30 [hp_C]/mL N 20191231 71919-596_0acbe15c-5af6-4ba3-99ac-fd4f69fc2ca0 71919-596 HUMAN OTC DRUG Sabadilla 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Santoninum SANTONIN LIQUID ORAL 20100316 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SANTONIN 30 [hp_C]/mL N 20191231 71919-610_e1b7fdd5-191d-45b3-ab06-73a015813a27 71919-610 HUMAN OTC DRUG Saponaria officinalis SAPONARIA OFFICINALIS ROOT LIQUID ORAL 20100316 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SAPONARIA OFFICINALIS ROOT 30 [hp_C]/mL N 20191231 71919-612_452fa54b-175a-4e4c-8b1d-6f9ade3d2a7b 71919-612 HUMAN OTC DRUG Sarracenia purpurea SARRACENIA PURPUREA LIQUID ORAL 20091106 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SARRACENIA PURPUREA 30 [hp_C]/mL N 20191231 71919-613_735a066e-b4b5-4e3c-954b-5a7fd9d75d8b 71919-613 HUMAN OTC DRUG Sarsaparilla SMILAX ORNATA ROOT LIQUID ORAL 20100504 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SMILAX ORNATA ROOT 30 [hp_C]/mL N 20191231 71919-614_7220898d-c136-4366-84d2-d01e06bd3227 71919-614 HUMAN OTC DRUG Scilla maritima DRIMIA MARITIMA BULB LIQUID ORAL 20090408 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DRIMIA MARITIMA BULB 30 [hp_C]/mL N 20191231 71919-615_6f39c4f8-7f7a-427e-9baf-4dafe231d104 71919-615 HUMAN OTC DRUG Scolopendra SCOLOPENDRA SUBSPINIPES LIQUID ORAL 20101019 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SCOLOPENDRA SUBSPINIPES 30 [hp_C]/mL N 20191231 71919-616_d1b770cd-b652-4d8f-9f0f-0b3393aeb9da 71919-616 HUMAN OTC DRUG Scrophularia nodosa SCROPHULARIA NODOSA LIQUID ORAL 20091231 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SCROPHULARIA NODOSA 30 [hp_C]/mL N 20191231 71919-617_fff6427d-8a1e-4de4-9653-12a59321c1e6 71919-617 HUMAN OTC DRUG Scutellaria lateriflora SCUTELLARIA LATERIFLORA LIQUID ORAL 20100401 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SCUTELLARIA LATERIFLORA 30 [hp_C]/mL N 20191231 71919-618_e7f74039-fcce-4e02-9e98-582e891b8225 71919-618 HUMAN OTC DRUG Secale cornutum CLAVICEPS PURPUREA SCLEROTIUM LIQUID ORAL 20091210 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products CLAVICEPS PURPUREA SCLEROTIUM 30 [hp_C]/mL N 20191231 71919-619_3cfcfa22-047e-4a18-98bc-a13c7f08e387 71919-619 HUMAN OTC DRUG Sedum acre SEDUM ACRE LIQUID ORAL 20091210 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SEDUM ACRE 30 [hp_C]/mL N 20191231 71919-620_50763b0e-ab3e-4c84-b54d-99f3f5a3b9d6 71919-620 HUMAN OTC DRUG Selenium metallicum SELENIUM LIQUID ORAL 20100409 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SELENIUM 30 [hp_C]/mL N 20191231 71919-622_dd667f97-92b3-4d51-bb34-ce9a63ac88a8 71919-622 HUMAN OTC DRUG Sempervivum tectorum SEMPERVIVUM TECTORUM LEAF LIQUID ORAL 20090603 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SEMPERVIVUM TECTORUM LEAF 30 [hp_C]/mL N 20191231 71919-623_f7b72fad-5612-41ca-b784-e48d6a407c07 71919-623 HUMAN OTC DRUG Senecio aureus PACKERA AUREA LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products PACKERA AUREA 30 [hp_C]/mL N 20191231 71919-624_1d1ddfac-41ae-45d5-8dff-ca47132cc745 71919-624 HUMAN OTC DRUG Senega officinalis POLYGALA SENEGA ROOT LIQUID ORAL 20100312 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products POLYGALA SENEGA ROOT 30 [hp_C]/mL N 20191231 71919-625_b96fb7ee-9b2d-4382-901c-e78e1ca2ea2f 71919-625 HUMAN OTC DRUG Senna SENNA LEAF LIQUID ORAL 20100203 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SENNA LEAF 30 [hp_C]/mL N 20191231 71919-626_eb175c10-da62-41f3-b3f8-82ebd07e92d4 71919-626 HUMAN OTC DRUG Sepia SEPIA OFFICINALIS JUICE LIQUID ORAL 20091112 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SEPIA OFFICINALIS JUICE 30 [hp_C]/mL N 20191231 71919-627_0100a357-3a47-43f1-a3cd-f44b194e0a0f 71919-627 HUMAN OTC DRUG Serum anguillae ANGUILLA ROSTRATA BLOOD SERUM LIQUID ORAL 20091021 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products ANGUILLA ROSTRATA BLOOD SERUM 30 [hp_C]/mL N 20191231 71919-629_79b53b5d-bf73-4f3f-bf0a-51d80c014aca 71919-629 HUMAN OTC DRUG Silicea SILICON DIOXIDE LIQUID ORAL 20100114 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SILICON DIOXIDE 30 [hp_C]/mL N 20191231 71919-631_507a937e-9bf8-40b8-8e7c-b6d5b42761fc 71919-631 HUMAN OTC DRUG Sinapis nigra BLACK MUSTARD SEED LIQUID ORAL 20091028 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products BLACK MUSTARD SEED 30 [hp_C]/mL N 20191231 71919-633_319978ff-5ca4-40bf-9eca-0020a59a1891 71919-633 HUMAN OTC DRUG Solanum nigrum SOLANUM NIGRUM WHOLE LIQUID ORAL 20090612 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SOLANUM NIGRUM WHOLE 30 [hp_C]/mL N 20191231 71919-634_99af3b33-9b88-457b-82a3-1f354dd0a7b4 71919-634 HUMAN OTC DRUG Solanum tuberosum SOLANUM TUBEROSUM LIQUID ORAL 20090512 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SOLANUM TUBEROSUM 30 [hp_C]/mL N 20191231 71919-637_93c8f413-06a7-418e-a2a0-83abd5942cf1 71919-637 HUMAN OTC DRUG Spiraea ulmaria FILIPENDULA ULMARIA ROOT LIQUID ORAL 20100621 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products FILIPENDULA ULMARIA ROOT 30 [hp_C]/mL N 20191231 71919-638_661b8afa-df5c-4348-868d-79cf9cee61c8 71919-638 HUMAN OTC DRUG Spiranthes autumnalis SPIRANTHES SPIRALIS ROOT LIQUID ORAL 20090105 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SPIRANTHES SPIRALIS ROOT 30 [hp_C]/mL N 20191231 71919-639_d9e69439-23ae-4401-b546-e64392c774c0 71919-639 HUMAN OTC DRUG Spongia tosta SPONGIA OFFICINALIS SKELETON, ROASTED LIQUID ORAL 20091120 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_C]/mL N 20191231 71919-640_118b623e-7c13-4a0e-9674-fae3562fef3f 71919-640 HUMAN OTC DRUG Stannum iodatum STANNOUS IODIDE LIQUID ORAL 20100212 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products STANNOUS IODIDE 30 [hp_C]/mL N 20191231 71919-641_fa672a2e-5ca6-4b00-bc7d-0d4bff2dfec4 71919-641 HUMAN OTC DRUG Stannum metallicum TIN LIQUID ORAL 20100615 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products TIN 30 [hp_C]/mL N 20191231 71919-642_72484377-94e6-4f69-acd2-d1864209e642 71919-642 HUMAN OTC DRUG Staphysagria DELPHINIUM STAPHISAGRIA SEED LIQUID ORAL 20091016 UNAPPROVED HOMEOPATHIC Washington Homeopathic Products DELPHINIUM STAPHISAGRIA SEED 30 [hp_C]/mL N 20191231 71922-100_25c2bd34-6be3-4433-b4f6-d49e7de8be3c 71922-100 HUMAN OTC DRUG Candee Caine Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 American Medical & Hospital Supply Co., Inc. BENZOCAINE 200 mg/g N 20181231 71922-101_40efa07c-fa57-4b7b-946a-0c06d1129426 71922-101 HUMAN OTC DRUG Candee Caine Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 American Medical & Hospital Supply Co., Inc. BENZOCAINE 200 mg/g N 20181231 71922-102_2676986b-dfac-40fb-90bf-4adce652a311 71922-102 HUMAN OTC DRUG Candee Caine Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 American Medical & Hospital Supply Co., Inc. BENZOCAINE 200 mg/g N 20181231 71922-103_59178876-8d36-44b2-b32e-2c3f3fab886b 71922-103 HUMAN OTC DRUG Candee Caine Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 American Medical & Hospital Supply Co., Inc. BENZOCAINE 200 mg/g N 20181231 71922-104_c6ae7310-05c5-4253-bd4b-8a2031fb7d6c 71922-104 HUMAN OTC DRUG Candee Caine Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 American Medical & Hospital Supply Co., Inc. BENZOCAINE 200 mg/g N 20181231 71922-105_69f0aeba-b90e-409a-8534-301c31a520cf 71922-105 HUMAN OTC DRUG Candee Caine Topical Anesthetic Benzocaine GEL DENTAL 20130701 OTC MONOGRAPH NOT FINAL part356 American Medical & Hospital Supply Co., Inc. BENZOCAINE 200 mg/g N 20181231 71925-400_fabf16dd-a6fd-4c7a-aa37-9d6bff1eefb5 71925-400 HUMAN OTC DRUG RADIANCE Antibacterial Plum Foam Handwash Benzalkonium Chloride LIQUID TOPICAL 20170430 OTC MONOGRAPH NOT FINAL part333E Pollock Investments Incorporated BENZALKONIUM CHLORIDE .005 mg/mL N 20181231 71927-001_600b618b-183b-18f6-e053-2a91aa0ae7ff 71927-001 HUMAN OTC DRUG Hand Sanitizer ETHYL ALCOHOL GEL TOPICAL 20171211 OTC MONOGRAPH NOT FINAL part333E Orazen Inc ALCOHOL 62 mL/100mL N 20181231 71928-7011_60139664-3eb8-47fd-e053-2991aa0ad073 71928-7011 HUMAN OTC DRUG Wet Naps Antibacterial Hand Wipes Antibacterial Hand Wipes SWAB TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part333A Westrock Rkt Company BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 71928-7012_60642333-58c4-0b95-e053-2a91aa0a719e 71928-7012 HUMAN OTC DRUG Wet Naps Antibacterial Hand Wipes Antibacterial Hand Wipes CLOTH TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part333A Westrock Rkt Company BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 71933-0001_60bd4e9a-e08d-a533-e053-2991aa0a7983 71933-0001 HUMAN OTC DRUG ANCEE DNA EYE Glycerin CREAM TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part347 SPARKJD Inc. GLYCERIN 8.006 g/100mL N 20181231 71933-0002_60be6095-6195-40e4-e053-2a91aa0aea4e 71933-0002 HUMAN OTC DRUG ANCEE DNA EYE Glycerin CREAM TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part347 SPARKJD Inc. GLYCERIN 8.006 g/100mL N 20181231 71933-0003_60bf95ff-8051-fe22-e053-2a91aa0ab81b 71933-0003 HUMAN OTC DRUG INTENSIVE HYDRATING CLEANSE PREMIUM DNA MASK PACK Glycerin KIT TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part347 SPARKJD Inc. N 20181231 71946-010_f8184a5c-4b55-48bd-b819-a960c8e86289 71946-010 HUMAN OTC DRUG Hair Loss and Scalp Moisturizing PALM, COCONUT SOAP TOPICAL 20171201 UNAPPROVED DRUG OTHER Selenia PALM OIL; COCONUT OIL 61; 24.9 g/105g; g/105g N 20191231 71946-020_ba0d3e9d-0603-4cd7-8d76-eba189a65b52 71946-020 HUMAN OTC DRUG SULFUR Niacinamide, Adenosine CREAM TOPICAL 20171201 UNAPPROVED DRUG OTHER Selenia NIACINAMIDE; ADENOSINE 1.4; .02 g/70mL; g/70mL N 20191231 71947-010_ae99495a-5a15-4dcc-8847-c8a16d264d36 71947-010 HUMAN OTC DRUG Snow Milk Sheet Mask Normal Niacinamide, Adenosine PATCH TOPICAL 20171201 UNAPPROVED DRUG OTHER Information Solution & Commerce Co., Ltd. NIACINAMIDE; ADENOSINE .5; .01 g/25mL; g/25mL N 20191231 71947-020_b85197da-ea7f-48bd-b5c0-85d8edb3c19e 71947-020 HUMAN OTC DRUG Snow Milk Sheet Mask Light Niacinamide, Adenosine PATCH TOPICAL 20171201 UNAPPROVED DRUG OTHER Information Solution & Commerce Co., Ltd. NIACINAMIDE; ADENOSINE .5; .01 g/25mL; g/25mL N 20191231 71947-030_a364608b-58a8-43dd-a916-815a3b8a9ec6 71947-030 HUMAN OTC DRUG Snow Milk Sheet Mask Rich Niacinamide, Adenosine PATCH TOPICAL 20171201 UNAPPROVED DRUG OTHER Information Solution & Commerce Co., Ltd. NIACINAMIDE; ADENOSINE .5; .01 g/25mL; g/25mL N 20191231 71948-101_2a300779-8adc-4113-834f-bcf43277a6f2 71948-101 HUMAN OTC DRUG THE BLACK Patch Menthol PATCH TOPICAL 20171230 OTC MONOGRAPH NOT FINAL part348 Carbon Innovation, Inc. MENTHOL 4 g/100g N 20191231 71955-100_6182bea6-1607-c6f9-e053-2a91aa0a5f51 71955-100 HUMAN OTC DRUG Ageranium Patch Capsaicin PATCH TOPICAL 20171229 OTC MONOGRAPH NOT FINAL part348 Entom Co., Ltd. CAPSAICIN .228 mg/99.13mg N 20181231 71957-0001_61c20cf5-538d-be22-e053-2a91aa0abbf7 71957-0001 HUMAN OTC DRUG CLEANING-S POTASSIUM CARBONATE LIQUID TOPICAL 20180102 UNAPPROVED DRUG OTHER NARO, INC. POTASSIUM CARBONATE .1 g/100mL N 20191231 71957-0002_628afb5f-46e1-11ec-e053-2991aa0ad4e2 71957-0002 HUMAN OTC DRUG FOOD-S POTASSIUM CARBONATE LIQUID ORAL; TOPICAL 20180102 UNAPPROVED DRUG OTHER NARO, INC. POTASSIUM CARBONATE .1 g/100mL N 20191231 71957-0003_61c3305e-a44f-1ad9-e053-2a91aa0a6b63 71957-0003 HUMAN OTC DRUG FACE-BODY-S POTASSIUM CARBONATE LIQUID TOPICAL 20180102 UNAPPROVED DRUG OTHER NARO, INC. POTASSIUM CARBONATE .1 g/100mL N 20191231 71960-0002_628b8594-9e42-374c-e053-2991aa0ab00d 71960-0002 HUMAN OTC DRUG GREEN GEMSTONE peppermint PILL TOPICAL 20171129 UNAPPROVED DRUG OTHER Myeong SA PEPPERMINT 20 g/100g N 20191231 71962-0001_623ef02e-86bc-3a18-e053-2991aa0ad2c6 71962-0001 HUMAN OTC DRUG Beaurangcell Quercus Acutissima Sap PATCH TOPICAL 20171129 UNAPPROVED DRUG OTHER Modoo plan QUERCUS ACUTISSIMA WHOLE 10 g/100mL N 20191231 71965-351_4b3374e5-bf89-4a80-b8bd-e3e3e5035773 71965-351 HUMAN OTC DRUG Gentle Mineneral Sunscreen SPF30 Zinc Oxide LOTION TOPICAL 20171212 OTC MONOGRAPH NOT FINAL part352 Jakks Pacific, Inc ZINC OXIDE 19 g/100mL N 20181231 71967-0001_60df178b-6e9c-9233-e053-2991aa0a8086 71967-0001 HUMAN OTC DRUG Natural Oriental Herb Care butylene glycol SHAMPOO TOPICAL 20171219 UNAPPROVED DRUG OTHER Wonilbio Inc BUTYLENE GLYCOL 1 g/100g N 20181231 71971-9060_4984c6c8-d066-4c93-972d-5b6d341aa6a8 71971-9060 HUMAN OTC DRUG Kids Relief Teething Oral Liquid chamomilla, arnica montana, borax, hypericum perforatum liquid LIQUID ORAL 20170303 UNAPPROVED HOMEOPATHIC Homeolab International (Canada) inc MATRICARIA RECUTITA; ARNICA MONTANA; SODIUM BORATE; HYPERICUM PERFORATUM 5; 5; 5; 5 [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL; [hp_C]/25mL N 20181231 71972-010_4d89a623-c2ed-479a-a63c-ee8d27f6f0b5 71972-010 HUMAN OTC DRUG TROIAREUKE ACSEN UV PROTECTOR ESSENCE Octinoxate, Homosalate, Octisalate, Titanium Dioxide CREAM TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part352 Mk Universal Inc. OCTINOXATE; HOMOSALATE; OCTISALATE; TITANIUM DIOXIDE 3.5; 1.5; 1.5; .74 g/50mL; g/50mL; g/50mL; g/50mL N 20191231 71974-010_7561dd63-ba07-40a2-9124-b88df771b87e 71974-010 HUMAN OTC DRUG SKINMD LABORATORIES REVIGE L Dimethicone GEL TOPICAL 20171201 OTC MONOGRAPH FINAL part347 Reviresco Co., Ltd. DIMETHICONE 1.61 g/50mL N 20181231 71974-020_a761e30a-d18d-4219-864e-8470c170637e 71974-020 HUMAN OTC DRUG SKINMD LABORATORIES PURE WHITENOL INTENSIVE Tranexamic acid, Adenosine CREAM TOPICAL 20171201 UNAPPROVED DRUG OTHER Reviresco Co., Ltd. TRANEXAMIC ACID; ADENOSINE .02; .004 g/10mL; g/10mL N 20181231 71974-030_74ec3ee6-af0f-4f64-bbf7-d0749bd9643e 71974-030 HUMAN OTC DRUG SKINMD LABORATORIES PURE WHITENOL SERUM Tranexamic acid CREAM TOPICAL 20171201 UNAPPROVED DRUG OTHER Reviresco Co., Ltd. TRANEXAMIC ACID .05 g/50mL N 20181231 71974-040_7c0cf498-c3bf-468d-b517-03ffbc14db0f 71974-040 HUMAN OTC DRUG SKINMD LABORATORIES ReviTox blue Adenosine, Tranexamic acid LIQUID TOPICAL 20171201 UNAPPROVED DRUG OTHER Reviresco Co., Ltd. ADENOSINE; TRANEXAMIC ACID .004; .001 g/10mL; g/10mL N 20181231 71975-010_a41192b5-437d-424b-9549-13b3c7c1bf82 71975-010 HUMAN OTC DRUG Ultra V RENEWDERM PLUS Dimethicone CREAM TOPICAL 20180102 OTC MONOGRAPH FINAL part347 Ultra V Co., Ltd DIMETHICONE 3.81 g/50mL N 20191231 71975-020_6aa6bcac-dcfe-4f30-a903-8771b8f4211f 71975-020 HUMAN OTC DRUG Ultra V IDEBENONE AMPOULE Niacinamide, Adenosine LIQUID TOPICAL 20180102 UNAPPROVED DRUG OTHER Ultra V Co., Ltd NIACINAMIDE; ADENOSINE .12; .002 g/6mL; g/6mL N 20191231 71975-030_ac8b0edc-878d-41ec-a8e5-1186c532a072 71975-030 HUMAN OTC DRUG Ultra V IDEBENONE NUTRITIONAL Niacinamide, Adenosine CREAM TOPICAL 20180102 UNAPPROVED DRUG OTHER Ultra V Co., Ltd NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20191231 71975-040_54dd8513-7aef-4ece-9f16-5704008bba3c 71975-040 HUMAN OTC DRUG Ultra V IDEBANONE Niacinamide, Adenosine CREAM TOPICAL 20180102 UNAPPROVED DRUG OTHER Ultra V Co., Ltd NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20191231 71975-050_280f0618-596a-49e1-98f3-d4f26edfdeb8 71975-050 HUMAN OTC DRUG Ultra V AQUA SHINE MASK Niacinamide PATCH TOPICAL 20180102 UNAPPROVED DRUG OTHER Ultra V Co., Ltd NIACINAMIDE .5 g/25mL N 20191231 71975-060_3e7a3b08-a763-400f-bad8-8b0a2d9d7d7a 71975-060 HUMAN OTC DRUG Ultra V IDEBENONE SKINFIT CUSHION Titanium Dioxide, Octinoxate, Zinc Oxide POWDER TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Ultra V Co., Ltd TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 1.4; .7; .27 g/14g; g/14g; g/14g N 20191231 71975-070_e95cb01d-82c4-49da-be4a-165bc5d8a029 71975-070 HUMAN OTC DRUG Ultra V IDEBENONE SUNBLOCK Homosalate, AVOBENZONE, ENSULIZOLE CREAM TOPICAL 20180102 OTC MONOGRAPH NOT FINAL part352 Ultra V Co., Ltd HOMOSALATE; AVOBENZONE; ENSULIZOLE 5; 1.75; 1.75 g/50mL; g/50mL; g/50mL N 20191231 71976-101_61e1497d-40f1-0c87-e053-2991aa0a2943 71976-101 HUMAN OTC DRUG Butt Butter Zinc Oxide OINTMENT TOPICAL 20180108 OTC MONOGRAPH FINAL part347 Littles Skin Care, Incorporated ZINC OXIDE 10 g/100g N 20191231 71976-301_62446e7e-fd85-9ae8-e053-2a91aa0a9d1b 71976-301 HUMAN OTC DRUG Eczema Relief oatmeal OINTMENT TOPICAL 20180118 OTC MONOGRAPH FINAL part347 Littles Skin Care, Inc ALLANTOIN; OATMEAL 1; 1 g/100g; g/100g N 20191231 71976-501_62e35819-c7ce-1ac4-e053-2a91aa0aab14 71976-501 HUMAN OTC DRUG Littles Vapor Rub Camphor, Eucalyptus oil, Menthol OINTMENT TOPICAL 20180126 OTC MONOGRAPH FINAL part341 Littles Skin Care, Inc CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL 4.8; 1.2; 2.6 g/100g; g/100g; g/100g N 20191231 71976-602_62e82676-1451-90f5-e053-2991aa0a4a88 71976-602 HUMAN OTC DRUG Littles All Natural Arthritic Pain Relief Capsacin OINTMENT TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part348 Littles Skin Care, Inc. CAPSAICIN; MENTHOL .1; 10 g/100g; g/100g N 20191231 71977-125_6154d28a-3bd9-c7fc-e053-2991aa0a8826 71977-125 HUMAN OTC DRUG BRAZILIAN MENTHOL Pain Relieving Roll On MENTHOL CREAM TOPICAL 20171227 OTC MONOGRAPH NOT FINAL part348 DDR Product, LLC MENTHOL 100 mg/mL N 20181231 71977-126_6154b58e-d1dc-9114-e053-2991aa0a38ae 71977-126 HUMAN OTC DRUG BRAZILIAN MENTHOL Pain Relieving MENTHOL CREAM TOPICAL 20171227 OTC MONOGRAPH NOT FINAL part348 DDR Product, LLC MENTHOL 100 mg/mL N 20181231 71982-010_9f56cf81-d319-4c6e-81a1-7e1207ea4269 71982-010 HUMAN OTC DRUG ECO BARRIER NON CHEMICAL SUN Zinc Oxide, Titanium Dioxide CREAM TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part352 JEIL H&B INC. ZINC OXIDE; TITANIUM DIOXIDE 5; 4 g/50mL; g/50mL N 20191231 71987-000_6299f17b-5876-2514-e053-2991aa0a5a12 71987-000 HUMAN OTC DRUG Complexion Protection Titanium Dioxide CREAM TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part352 Hale Comeceuticals TITANIUM DIOXIDE 75 mg/mL N 20191231 71987-001_629a3407-13b8-36f3-e053-2991aa0a6e39 71987-001 HUMAN OTC DRUG Complexion Protection Moisturizing Sunscreen Titanium Dioxide CREAM TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part352 Hale Comeceuticals TITANIUM DIOXIDE 75 mg/mL N 20191231 71987-002_629a3407-13ff-36f3-e053-2991aa0a6e39 71987-002 HUMAN OTC DRUG Complexion Perfection BB Titanium Dioxide CREAM TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part352 Hale Comeceuticals TITANIUM DIOXIDE 50 mg/mL N 20191231 71990-001_288bb3c0-3267-4c55-a616-4961f9ac4350 71990-001 HUMAN OTC DRUG Witch Hazel Witch Hazel LIQUID TOPICAL 20120315 OTC MONOGRAPH FINAL part347 Arcadia Beauty Labs LLC WITCH HAZEL 86 mg/100mL N 20191231 71995-020_4a8ed82d-b636-48c5-83c4-6e136d02a6c1 71995-020 HUMAN OTC DRUG 2XL Mega Rolls Sanitizing Wipes Benzalkonium chloride SWAB TOPICAL 20170316 OTC MONOGRAPH NOT FINAL part333A 2xl Corporation BENZALKONIUM CHLORIDE .13 g/100g N 20191231 72001-0001_62792284-91d2-16bd-e053-2991aa0a3d61 72001-0001 HUMAN OTC DRUG Bano White Jade InjectionMask Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 Banobagi Co., Ltd. GLYCERIN 10 g/100g N 20191231 72001-0002_6279eef3-766c-bedd-e053-2991aa0ad9b1 72001-0002 HUMAN OTC DRUG Bano Baby Face InjectionMask Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 Banobagi Co., Ltd. GLYCERIN 2.5 g/100g N 20191231 72001-0003_6279eef3-7679-bedd-e053-2991aa0ad9b1 72001-0003 HUMAN OTC DRUG Bano Anti-Oxidant InjectionMask Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 Banobagi Co., Ltd. GLYCERIN 2.5 g/100g N 20191231 72001-0004_6279eef3-7689-bedd-e053-2991aa0ad9b1 72001-0004 HUMAN OTC DRUG Bano Water Glow InjectionMask Glycerin LIQUID TOPICAL 20180109 OTC MONOGRAPH NOT FINAL part347 Banobagi Co., Ltd. GLYCERIN 10 g/100g N 20191231 72016-140_6280edbe-55a9-5f4e-e053-2991aa0ac7b5 72016-140 HUMAN OTC DRUG Pure InflaMedix Natural Pain Relief MENTHOL CREAM TOPICAL 20180110 OTC MONOGRAPH NOT FINAL part348 Nutragen Health Innovations, Inc. MENTHOL 30 mg/mL N 20191231 72019-0001_61d06b61-529a-2627-e053-2991aa0a70ed 72019-0001 HUMAN OTC DRUG Riversol Lightweight Broad Spectrum Sunscreen Spf 30 Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20180125 OTC MONOGRAPH NOT FINAL part352 Riversol Skincare Solutions Inc ZINC OXIDE; TITANIUM DIOXIDE 100; .09883 mg/mL; g/mL N 20191231 72024-770_578aba86-7cc2-4b89-9c8d-607f558f8252 72024-770 HUMAN OTC DRUG Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20180103 OTC MONOGRAPH NOT FINAL part333A Fastenal ALCOHOL 70 mL/100mL N 20191231 72025-001_635f77cf-00a3-5b21-e053-2991aa0a010d 72025-001 HUMAN OTC DRUG AquaWhite Cavity FightingTooth SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20161128 OTC MONOGRAPH FINAL part355 JHS SVENDGAARD LABORATORIES LIMITED SODIUM MONOFLUOROPHOSPHATE .1 g/100g N 20191231 72025-002_62e85fcc-0701-17a9-e053-2991aa0ac526 72025-002 HUMAN OTC DRUG AquaWhite Blue Gel Cavity FightingTooth SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20180116 OTC MONOGRAPH FINAL part355 JHS SVENDGAARD LABORATORIES LIMITED SODIUM MONOFLUOROPHOSPHATE .1 g/100g N 20191231 72025-003_62e88bbf-b2c1-50fa-e053-2991aa0a70e2 72025-003 HUMAN OTC DRUG AquaWhite Red Gel Cavity FightingTooth SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ORAL 20180116 OTC MONOGRAPH FINAL part355 JHS SVENDGAARD LABORATORIES LIMITED SODIUM MONOFLUOROPHOSPHATE .1 g/100g N 20191231 72026-881_a9d1dc04-cf2f-4b17-8a62-61e2243fb6af 72026-881 HUMAN OTC DRUG Quali Patch (Cold) Methyl Salicylate, Menthol, Camphor PATCH TOPICAL 20131010 20331010 OTC MONOGRAPH NOT FINAL part348 Finemost Corporation METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 2; 1; .5 g/100g; g/100g; g/100g N 20191231 72026-882_9dc15f32-715e-479d-a39a-1492d8b13c06 72026-882 HUMAN OTC DRUG Quali Patch Warm MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20131010 20331010 OTC MONOGRAPH NOT FINAL part348 Finemost Corporation MENTHOL; METHYL SALICYLATE 3; .8 g/100g; g/100g N 20191231 72026-883_b3a6d2fb-c3c9-4c02-85c7-e3992257bf15 72026-883 HUMAN OTC DRUG Quali Patch Herbal Soultice MENTHOL, METHYL SALICYLATE PATCH TOPICAL 20131010 20331010 OTC MONOGRAPH NOT FINAL part348 Finemost Corporation MENTHOL; METHYL SALICYLATE 10; .5 g/100g; g/100g N 20191231 72030-001_c397db61-3e12-40d6-8d94-60a756edb2ec 72030-001 HUMAN OTC DRUG YINCHIAO ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE TABLET, COATED ORAL 20180118 OTC MONOGRAPH FINAL part341 ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 60; .667 mg/1; mg/1 N 20191231 72033-000_63ef7aa1-7e8e-17b9-e053-2a91aa0a5799 72033-000 HUMAN OTC DRUG KUB Cartridge Refill Antiseptic Hand Sanitizer Unscented ALCOHOL LIQUID TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part333E Touchland LLC ALCOHOL 670 mg/mL N 20191231 72033-001_63ef627d-bfdb-6435-e053-2a91aa0adbba 72033-001 HUMAN OTC DRUG Touchland Power Mist Moisturizing Hand Sanitizer Aloe Vera Scented ALCOHOL LIQUID TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part333E Touchland LLC ALCOHOL 670 mg/mL N 20191231 72033-002_63ef94ab-aa61-5bc8-e053-2991aa0ae083 72033-002 HUMAN OTC DRUG Touchland Power Mist Moisturizing Hand Sanitizer Citrus Scented ALCOHOL LIQUID TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part333E Touchland LLC ALCOHOL 670 mg/mL N 20191231 72033-003_63ef94ab-aa63-5bc8-e053-2991aa0ae083 72033-003 HUMAN OTC DRUG Touchland Power Mist Moisturizing Hand Sanitizer Forest Berry Scented ALCOHOL LIQUID TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part333E Touchland LLC ALCOHOL 670 mg/mL N 20191231 72033-004_63ef7aa1-7f50-17b9-e053-2a91aa0a5799 72033-004 HUMAN OTC DRUG Touchland Power Mist Moisturizing Hand Sanitizer Lavender Scented ALCOHOL LIQUID TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part333E Touchland LLC ALCOHOL 670 mg/mL N 20191231 72033-005_63efa093-a47b-51c4-e053-2a91aa0a618e 72033-005 HUMAN OTC DRUG Touchland Power Mist Moisturizing Hand Sanitizer Mint Scented ALCOHOL LIQUID TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part333E Touchland LLC ALCOHOL 670 mg/mL N 20191231 72033-006_63efa093-a48b-51c4-e053-2a91aa0a618e 72033-006 HUMAN OTC DRUG Touchland Power Mist Moisturizing Hand Sanitizer Neutral Scented ALCOHOL LIQUID TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part333E Touchland LLC ALCOHOL 670 mg/mL N 20191231 72033-007_63efa3c5-cb1a-6a9c-e053-2991aa0a7605 72033-007 HUMAN OTC DRUG Touchland Power Mist Moisturizing Hand Sanitizer Vanilla Cinnamon Scented ALCOHOL LIQUID TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part333E Touchland LLC ALCOHOL 670 mg/mL N 20191231 72033-008_63efa093-a4ab-51c4-e053-2a91aa0a618e 72033-008 HUMAN OTC DRUG Touchland Power Mist Moisturizing Hand Sanitizer Watermelon Scented ALCOHOL LIQUID TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part333E Touchland LLC ALCOHOL 670 mg/mL N 20191231 72036-001_7f644a42-809c-4364-a86f-81cc6706397f 72036-001 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20110301 OTC MONOGRAPH FINAL part355 Harris Teeter SODIUM FLUORIDE 1 mg/mL N 20181231 72036-005_ff7a2f95-dc60-4f80-bcba-ed41826e80fd 72036-005 HUMAN OTC DRUG Milk of Magnesia Magnesium Hydroxide LIQUID ORAL 20160128 OTC MONOGRAPH NOT FINAL part334 Harris Teeter MAGNESIUM HYDROXIDE 1200 mg/15mL N 20181231 72036-006_7f7f0b49-2298-492a-b1d0-42abdc25b777 72036-006 HUMAN OTC DRUG STOMACH RELIEF Bismuth Subsalicylate LIQUID ORAL 20170401 OTC MONOGRAPH FINAL part335 Harris Teeter BISMUTH SUBSALICYLATE 525 mg/30mL N 20181231 72036-007_3f9efbb6-61e7-41cc-a122-83e15354ae88 72036-007 HUMAN OTC DRUG Maximum Strength Stomach Relief Bismuth Subsalicylate LIQUID ORAL 20170401 OTC MONOGRAPH FINAL part335 Harris Teeter BISMUTH SUBSALICYLATE 1050 mg/30mL N 20181231 72036-026_bc548297-7646-4dbf-bfc5-65f2bc629676 72036-026 HUMAN OTC DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20160426 ANDA ANDA206531 Harris Teeter FAMOTIDINE 20 mg/1 N 20181231 72036-030_49244ec4-ae52-6631-e054-00144ff88e88 72036-030 HUMAN OTC DRUG menthol cough drop menthol LOZENGE ORAL 20130408 OTC MONOGRAPH FINAL part341 Harris Teeter MENTHOL 5.4 mg/1 N 20181231 72036-031_4b3eff5f-5726-3b12-e054-00144ff88e88 72036-031 HUMAN OTC DRUG cherry cough drops menthol LOZENGE ORAL 20150911 OTC MONOGRAPH FINAL part341 Harris Teeter MENTHOL 5.8 mg/1 N 20181231 72036-032_4b3fbdec-ff31-638c-e054-00144ff88e88 72036-032 HUMAN OTC DRUG honey lemon cough drops menthol LOZENGE ORAL 20130408 OTC MONOGRAPH FINAL part341 Harris Teeter MENTHOL 7.5 mg/1 N 20181231 72036-033_4b40ca57-45cc-14d5-e054-00144ff88e88 72036-033 HUMAN OTC DRUG sugar free menthol cough drops menthol LOZENGE ORAL 20130408 OTC MONOGRAPH FINAL part341 Harris Teeter MENTHOL 5.8 mg/1 N 20181231 72036-034_603f182b-e4bc-8b56-e053-2a91aa0a257b 72036-034 HUMAN OTC DRUG menthol cough drops Menthol LOZENGE ORAL 20171213 OTC MONOGRAPH FINAL part341 Harris Teeter MENTHOL 5.4 mg/1 N 20181231 72036-035_6040939d-61d9-8a2d-e053-2991aa0a3690 72036-035 HUMAN OTC DRUG cherry cough drops Menthol LOZENGE ORAL 20171213 OTC MONOGRAPH FINAL part341 Harris Teeter MENTHOL 5.8 mg/1 N 20181231 72036-036_604e2884-b174-68d9-e053-2991aa0a6838 72036-036 HUMAN OTC DRUG honey lemon cough drops Menthol LOZENGE ORAL 20171214 OTC MONOGRAPH FINAL part341 Harris Teeter MENTHOL 7.5 mg/1 N 20181231 72036-055_2a21a223-dc90-42e9-baf9-cb1f42bfd847 72036-055 HUMAN OTC DRUG yourhome fresh scent Benzalkonium chloride CLOTH TOPICAL 20130527 OTC MONOGRAPH NOT FINAL part333A Harris Teeter BENZALKONIUM CHLORIDE .115 g/1 N 20181231 72036-069_6c69f311-c66b-4694-b2ee-ca828f3058ac 72036-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 20090209 OTC MONOGRAPH FINAL part347 Harris Teeter PETROLATUM 1 g/g N 20181231 72036-153_652849ce-4a17-40ff-8b18-6c1aab50396a 72036-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione Zinc SHAMPOO TOPICAL 19950215 OTC MONOGRAPH FINAL part358H Harris Teeter PYRITHIONE ZINC 1 mg/mL N 20181231 72036-163_6401cd2f-5966-414f-b4c7-f1dc5f224b39 72036-163 HUMAN OTC DRUG ANTIBACTERIAL FOAMING PEAR SCENT TRICLOSAN SOAP TOPICAL 20101115 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER TRICLOSAN .46 mL/100mL N 20181231 72036-168_344ffb50-e024-4fcc-877a-7aedcd6ecc91 72036-168 HUMAN OTC DRUG Harris Teeter Foaming TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter TRICLOSAN .6 mL/100mL N 20181231 72036-168_5975f954-f4cc-45a1-8d51-339b583dbdb3 72036-168 HUMAN OTC DRUG Harris Teeter Foaming TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter TRICLOSAN .6 mL/100mL N 20181231 72036-177_78639d39-dee1-4bc8-9610-f74a1d2ea7e5 72036-177 HUMAN OTC DRUG ANTIBACTERIAL FOAMING TRICLOSAN LIQUID TOPICAL 20110322 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER TRICLOSAN .46 mL/100mL N 20181231 72036-220_1bd6a5c9-612b-4072-b8a2-9c5a1fc5afeb 72036-220 HUMAN OTC DRUG Harris Teeter Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER TRICLOSAN .15 mL/100mL N 20181231 72036-220_1cf9ad82-fc49-4c08-b777-45ac2792aa3d 72036-220 HUMAN OTC DRUG Harris Teeter Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER TRICLOSAN .15 mL/100mL N 20181231 72036-220_ca72f631-774d-46db-a6fc-375aa549f321 72036-220 HUMAN OTC DRUG Harris Teeter Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER TRICLOSAN .15 mL/100mL N 20181231 72036-223_687c4a1e-0aef-494f-8019-24c4040ed147 72036-223 HUMAN OTC DRUG Harris Teeter Hand Sanitizer With Vitamin E and Aloe Alcohol GEL TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter ALCOHOL 62 mL/100mL N 20181231 72036-223_6e1b868b-4d3d-44cd-9033-e9d872a81815 72036-223 HUMAN OTC DRUG Harris Teeter Hand Sanitizer With Vitamin E and Aloe Alcohol GEL TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter ALCOHOL 62 mL/100mL N 20181231 72036-227_109051a4-c6b2-49b3-a5c2-489506e2aa7b 72036-227 HUMAN OTC DRUG Harris Teeter Hand Sanitizer With Vitamin E Alcohol GEL TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter ALCOHOL 62 mL/100mL N 20181231 72036-227_5b1cc4bd-c951-4d6a-a890-a2b45dac5610 72036-227 HUMAN OTC DRUG HARRIS TEETER HAND SANITIZER WITH VITAMIN E ALCOHOL GEL TOPICAL 20110126 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER ALCOHOL 62 mL/100mL N 20181231 72036-227_f3830943-bcea-4ddb-b5bd-fe989800cb3d 72036-227 HUMAN OTC DRUG Harris Teeter Hand Sanitizer With Vitamin E Alcohol GEL TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter ALCOHOL 62 mL/100mL N 20181231 72036-230_7fa5e510-38ef-4062-901d-c0a36d65bc2e 72036-230 HUMAN OTC DRUG INSTANT HAND SANITIZER WITH VITAMIN E ETHYL ALCOHOL GEL TOPICAL 20111025 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER ALCOHOL 62 mL/100mL N 20181231 72036-240_5b1e92d6-be03-4c12-a958-e6fa010b544d 72036-240 HUMAN OTC DRUG FOAMING HAND SANITIZER WITH ALOE BENZALKONIUM CHLORIDE LIQUID TOPICAL 20101116 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER BENZALKONIUM CHLORIDE .1 mL/100mL N 20181231 72036-294_e9480321-a0ab-4422-aa30-b7edf95ea224 72036-294 HUMAN OTC DRUG HARRIS TEETER ANTIBACTERIAL TRICLOSAN LIQUID TOPICAL 20120802 OTC MONOGRAPH NOT FINAL part333E HARRIS TEETER TRICLOSAN .15 mg/100mL N 20181231 72036-311_17ad571f-180a-4c8e-959b-2fb8254c8c38 72036-311 HUMAN OTC DRUG Dandruff pyrithione zinc LOTION/SHAMPOO TOPICAL 20040518 OTC MONOGRAPH FINAL part358H Harris Teeter PYRITHIONE ZINC 10 mg/mL N 20181231 72036-370_e207d5c4-03de-4626-b097-96b1b6aeb090 72036-370 HUMAN OTC DRUG Hand Sanitizer Alcohol GEL TOPICAL 20140717 OTC MONOGRAPH NOT FINAL part333A Harris Teeter, LLC ALCOHOL 70 mL/100mL N 20181231 72036-400_1e658cc8-d647-49f1-a909-24f068f020db 72036-400 HUMAN OTC DRUG Harris Teeter Triple Antibioitic Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate OINTMENT TOPICAL 20170418 OTC MONOGRAPH FINAL part333B Harris Teeter BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 72036-401_617abc95-5372-4504-a80e-2fd51fa22e1d 72036-401 HUMAN OTC DRUG Harris Teeter Triple Antibiotic Plus Pain Relief Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate, and Pramoxine hydrochloride OINTMENT TOPICAL 20170418 OTC MONOGRAPH FINAL part333B Harris Teeter BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 500; 3.5; 1000; 10 [iU]/g; mg/g; [iU]/g; mg/g N 20181231 72036-402_926407d4-32c1-4de7-85fc-85076a247ec3 72036-402 HUMAN OTC DRUG Harris Teeter Anti-Itch Diphenhydramine hydrochloride, and Zinc acetate CREAM TOPICAL 20170421 OTC MONOGRAPH NOT FINAL part348 Harris Teeter DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE 20; 1 mg/g; mg/g N 20181231 72036-403_fec3b215-343a-40c2-9002-6afe475c9dfc 72036-403 HUMAN OTC DRUG Harris Teeter Triple Antibiotic Plus Pain Relief Neomycin, Polymyxin B, and Pramoxine HCL CREAM TOPICAL 20170420 OTC MONOGRAPH NOT FINAL part348 Harris Teeter NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE 3.5; 10000; 10 mg/g; [USP'U]/g; mg/g N 20181231 72036-404_2fde37ba-4b10-4603-85de-6ed97fbede53 72036-404 HUMAN OTC DRUG Harris Teeter Anti-Itch Intensive Healing Hydrocortisone CREAM TOPICAL 20170420 OTC MONOGRAPH NOT FINAL part348 Harris Teeter HYDROCORTISONE 1 g/100g N 20181231 72036-405_4b78e5cc-5b1d-4909-a85e-9a06ebdfca2a 72036-405 HUMAN OTC DRUG Harris Teeter Anti-Itch Hydrocortisone CREAM TOPICAL 20170420 OTC MONOGRAPH NOT FINAL part348 Harris Teeter HYDROCORTISONE 1 g/100g N 20181231 72036-406_22947e37-84ad-4f67-bc04-75baf9435e8b 72036-406 HUMAN OTC DRUG Harris Teeter Maximum Strength Anti-Itch Hydrocortisone OINTMENT TOPICAL 20170417 OTC MONOGRAPH NOT FINAL part348 Harris Teeter HYDROCORTISONE 10 mg/g N 20181231 72036-407_2b90d9a3-ebb1-4aee-8a9c-6601618b7738 72036-407 HUMAN OTC DRUG Harris Teeter Anti-Itch with Aloe Hydrocortisone CREAM TOPICAL 20170419 OTC MONOGRAPH NOT FINAL part348 Harris Teeter HYDROCORTISONE 10 mg/g N 20181231 72036-408_2e4955f1-b5bd-4c23-9f78-82da5a63bc61 72036-408 HUMAN OTC DRUG Harris Teeter Anti-Itch Cooling Relief Hydrocortisone GEL TOPICAL 20170419 OTC MONOGRAPH NOT FINAL part348 Harris Teeter HYDROCORTISONE 10 mg/g N 20181231 72036-409_810b7bf5-9919-495a-8ab7-58673b0f9a62 72036-409 HUMAN OTC DRUG Harris Teeter Poly Antibiotic Bacitracin Zinc, and Polymyxin B Sulfate OINTMENT TOPICAL 20170418 OTC MONOGRAPH FINAL part333B Harris Teeter BACITRACIN ZINC; POLYMYXIN B SULFATE 500; 10000 [USP'U]/g; [USP'U]/g N 20181231 72036-439_e282a683-81b9-44c3-bcf0-5c91cf5e4f9a 72036-439 HUMAN OTC DRUG Advanced Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20140718 OTC MONOGRAPH NOT FINAL part333A Harris Teeter ALCOHOL 700 mg/mL N 20181231 72036-686_2a97dce0-c965-4275-a1ac-31dc9111dcbe 72036-686 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20170503 OTC MONOGRAPH NOT FINAL part334 Harris Teeter, LLC MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 72036-720_663da610-5cd4-41aa-924b-658b1b171ae7 72036-720 HUMAN OTC DRUG Harris Teeter Antibacterial TRICLOSAN SOAP TOPICAL 20101007 OTC MONOGRAPH NOT FINAL part333E Harris Teeter TRICLOSAN .115 mL/100mL N 20181231 72036-800_38b79d0d-d99e-4011-8a14-a56a3f75d8c3 72036-800 HUMAN OTC DRUG Esomeprazole Magnesium Esomeprazole Magnesium CAPSULE, DELAYED RELEASE ORAL 20171016 ANDA ANDA209339 Harris Teeter ESOMEPRAZOLE MAGNESIUM DIHYDRATE 20 mg/1 N 20181231 72036-980_826d9c3c-7535-48bb-906e-d75e2ec670db 72036-980 HUMAN OTC DRUG Mucus Relief DM Guaifenesin and Dextromethorphan HBr TABLET, EXTENDED RELEASE ORAL 20170317 ANDA ANDA206941 Harris Teeter GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE 1200; 60 mg/1; mg/1 N 20181231 72041-000_6327f079-17cc-ecb1-e053-2a91aa0a4f7e 72041-000 HUMAN OTC DRUG Eupepsia Thin PAULINIA CUPANA H.B ET K STRIP ORAL 20180111 UNAPPROVED HOMEOPATHIC Dalian Holyone Bio-Technologyco Ltd PAULLINIA CUPANA SEED 1 [hp_X]/1 N 20191231 72041-001_632863d8-756c-44a1-e053-2a91aa0a4586 72041-001 HUMAN OTC DRUG TBX-Free Laburnum anagyroides STRIP ORAL 20180111 UNAPPROVED HOMEOPATHIC Dalian Holyone Bio-Technologyco Ltd LABURNUM ANAGYROIDES POLLEN 1 [hp_X]/1 N 20191231 72045-000_6406bd06-f7f4-6502-e053-2991aa0aba54 72045-000 HUMAN OTC DRUG The Skateboarding Pain Relieving Liniment MENTHOL CREAM TOPICAL 20180117 OTC MONOGRAPH NOT FINAL part348 The Cream Skateboarding Liniment Pty Ltd MENTHOL 130 mg/g N 20191231 72047-010_9445c4dc-3e6d-4250-aac7-06a826046e71 72047-010 HUMAN OTC DRUG DoctorTibletKereale Sodium Fluoride PASTE, DENTIFRICE TOPICAL 20180102 OTC MONOGRAPH FINAL part355 TRAUM TRADERS SODIUM FLUORIDE .001 g/.7g N 20191231 72048-010_854a2157-5273-4546-8f03-2639561b5323 72048-010 HUMAN OTC DRUG LACSISN perfect all care SILICON DIOXIDE, ALCLOXA PASTE, DENTIFRICE TOPICAL 20180102 UNAPPROVED DRUG OTHER Team J F&B Co., Ltd. SILICON DIOXIDE; ALCLOXA 18; .19 g/120g; g/120g N 20191231 72049-010_839944d2-d592-46c0-b91d-1d7b8c14c27a 72049-010 HUMAN OTC DRUG CellStin Ampoule Black Niacinamide, Adenosine LIQUID TOPICAL 20180102 UNAPPROVED DRUG OTHER Woojin DMC Co.,Ltd. NIACINAMIDE; ADENOSINE .2; .004 g/10mL; g/10mL N 20191231 72049-020_840789ab-42f0-4014-b3e4-41481a1bceb6 72049-020 HUMAN OTC DRUG CellStin Micro Ampoule White Niacinamide, Adenosine LIQUID TOPICAL 20180102 UNAPPROVED DRUG OTHER Woojin DMC Co.,Ltd. NIACINAMIDE; ADENOSINE .2; .004 g/10mL; g/10mL N 20191231 72050-600_63af0769-6982-15b2-e053-2991aa0a6f62 72050-600 HUMAN OTC DRUG honey IM ON STAYCATION TONIGHT DIY FACE MASK ACNE TREATMENT SALICYLIC ACID KIT 20180125 OTC MONOGRAPH FINAL part333D HONEYPOP, LLC N 20191231 72053-000_647918a1-f4a0-ef01-e053-2a91aa0a11fb 72053-000 HUMAN OTC DRUG Tetracycline 3 percent a First Aid Antibiotic TETRACYCLINE HYDROCHLORIDE OINTMENT TOPICAL 20180202 OTC MONOGRAPH FINAL part333B Patient Focused Tele-Health, LLC TETRACYCLINE HYDROCHLORIDE 30 mg/g N 20191231 72058-010_ea608cbf-7668-4bb4-a631-bd8bcccb79ed 72058-010 HUMAN OTC DRUG do good Perfecting Aqua Ge l Moisturizer Niacinamide, Adenosine GEL TOPICAL 20180102 UNAPPROVED DRUG OTHER WOOREE Colourone Co.,Ltd NIACINAMIDE; ADENOSINE 1; .02 g/50mL; g/50mL N 20191231 72058-020_0bd25bb9-be9c-4061-b606-166fc09aeaac 72058-020 HUMAN OTC DRUG do good Perfecting Aqua Mask Niacinamide, Adenosine PATCH TOPICAL 20180102 UNAPPROVED DRUG OTHER WOOREE Colourone Co.,Ltd NIACINAMIDE; ADENOSINE .5; .01 g/25g; g/25g N 20191231 72058-030_4acb9c5c-d529-4f06-973a-5b9186dc9705 72058-030 HUMAN OTC DRUG do good Perfecting Aqua Mask 5ea Niacinamide, Adenosine PATCH TOPICAL 20180102 UNAPPROVED DRUG OTHER WOOREE Colourone Co.,Ltd NIACINAMIDE; ADENOSINE .5; .01 g/25g; g/25g N 20191231 72059-001_6428123f-895e-bc9e-e053-2991aa0a4f7d 72059-001 HUMAN OTC DRUG STING RELIEF MEDICATED PAD Benzocaine SWAB TOPICAL 20180201 OTC MONOGRAPH FINAL part333B Nantong Sirius Packing Products Co., Ltd. BENZOCAINE .06 mg/1 N 20191231 72059-002_6428a664-9e20-83c5-e053-2991aa0a4098 72059-002 HUMAN OTC DRUG Povidone-Iodine Prep Pad Povidone-Iodine SWAB PERCUTANEOUS 20180201 OTC MONOGRAPH FINAL part333C Nantong Sirius Packing Products Co., Ltd. POVIDONE-IODINE 10 mg/1 N 20191231 72059-003_6428febe-2b9f-27d2-e053-2991aa0ae40f 72059-003 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20180201 OTC MONOGRAPH NOT FINAL part333A Nantong Sirius Packing Products Co., Ltd. ISOPROPYL ALCOHOL .7 mL/1 N 20191231 72059-004_6428f7a5-bc12-5f4c-e053-2a91aa0a3c9d 72059-004 HUMAN OTC DRUG Benzalkonium Chloride Antiseptic benzalkonium chloride SWAB TOPICAL 20180201 OTC MONOGRAPH NOT FINAL part333A Nantong Sirius Packing Products Co., Ltd. BENZALKONIUM CHLORIDE .0013 mg/1 N 20191231 72059-005_64291ccf-9806-dbbb-e053-2991aa0adbc8 72059-005 HUMAN OTC DRUG Cleansing Towelette benzalkonium chloride SWAB TOPICAL 20180201 OTC MONOGRAPH NOT FINAL part333A Nantong Sirius Packing Products Co., Ltd. BENZALKONIUM CHLORIDE .13 mg/1 N 20191231 72068-0001_64210cdc-75c5-2536-e053-2991aa0abd64 72068-0001 HUMAN OTC DRUG INNER SAVE Feminine Cleansing Mist Adenosine LIQUID VAGINAL 20180101 UNAPPROVED DRUG OTHER ST Life Co.,Ltd. ADENOSINE 15 g/100mL N 20191231 72072-0001_641fbbe5-dd67-31e2-e053-2991aa0af804 72072-0001 HUMAN OTC DRUG SHYNOMORE LUBRICANT Centella Asiatica Extract GEL VAGINAL 20180101 UNAPPROVED DRUG OTHER Bluette Co., Ltd. CENTELLA ASIATICA 15 g/100mL N 20191231 72073-001_184423c1-164e-4a3f-8ad1-a7ccff959ab5 72073-001 HUMAN OTC DRUG RENARDBLANC MULTILAYER SUN BLOCK Octonoxate, Octisalate, Avobenzone, Homosalate CREAM TOPICAL 20180205 OTC MONOGRAPH NOT FINAL part352 Diamonie Seoul Cosmetic Co Ltd OCTINOXATE; OCTISALATE; AVOBENZONE; HOMOSALATE 3.6; 2.7; 1.5; 1.2 mg/60mL; mg/60mL; mg/60mL; mg/60mL N 20191231 72081-001_6469c4e0-af7c-2ab1-e053-2991aa0a85f3 72081-001 HUMAN OTC DRUG CopperGel Camphor, Menthol GEL TOPICAL 20180205 OTC MONOGRAPH NOT FINAL part348 CopperRelief, LLC MENTHOL; CAMPHOR (SYNTHETIC) 3.5; 3.5 g/100g; g/100g N 20191231 75826-114_534cce8f-801d-4357-8a5f-261675760996 75826-114 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20151223 UNAPPROVED DRUG OTHER Winder Laboratories, LLC PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1 N 20181231 75826-115_534cce8f-801d-4357-8a5f-261675760996 75826-115 HUMAN PRESCRIPTION DRUG Phenazopyridine Hydrochloride Phenazopyridine Hydrochloride TABLET ORAL 20151123 UNAPPROVED DRUG OTHER Winder Laboratories, LLC PHENAZOPYRIDINE HYDROCHLORIDE 200 mg/1 N 20181231 75826-118_a879806f-4c37-4e55-8e8e-89090a2c1214 75826-118 HUMAN PRESCRIPTION DRUG Phenohytro PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE TABLET ORAL 20160229 UNAPPROVED DRUG OTHER Winder Laboratories, LLC PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE 16.2; .1037; .0194; .0065 mg/1; mg/1; mg/1; mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 75830-002_457f63fc-0430-451f-aa12-7d401924d22f 75830-002 HUMAN OTC DRUG KGP Flush Berberis Vulgaris, Nux Vomica LIQUID ORAL 20111101 UNAPPROVED HOMEOPATHIC Baseline Nutritionals Inc. BERBERIS VULGARIS ROOT BARK; STRYCHNOS NUX-VOMICA SEED 6; 6 [hp_X]/118mL; [hp_X]/118mL N 20181231 75831-7732_1fbf1947-3e30-430e-9dd9-f41f35026597 75831-7732 HUMAN OTC DRUG DoctorRelief Menthol, Methyl Salicylate GEL TOPICAL 20091204 OTC MONOGRAPH FINAL part348 KPC Products Inc. MENTHOL; METHYL SALICYLATE; CAMPHOR (SYNTHETIC) 75; 38; 23 mg/g; mg/g; mg/g E 20171231 75834-040_908b202b-0135-41cd-97c1-dc6bd39f7204 75834-040 HUMAN OTC DRUG Nivanex DMX GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE TABLET ORAL 20141124 OTC MONOGRAPH FINAL part341 Nivagen Pharmaceuticals, Inc. GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 380; 15; 10 mg/1; mg/1; mg/1 E 20171231 75834-060_a3ec1e40-ffc2-4180-8c31-c3f398c1b849 75834-060 HUMAN OTC DRUG Niva-Hist DM BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE LIQUID ORAL 20141124 OTC MONOGRAPH FINAL part341 Nivagen Pharmaceuticals, Inc. BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 4; 7.5; 15 mg/5mL; mg/5mL; mg/5mL E 20171231 75834-100_103b4cf1-4b5d-44b3-89e2-a393ef4f2276 75834-100 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride TABLET ORAL 20160115 ANDA ANDA040747 Nivagen Pharmaceuticals, Inc. BENZPHETAMINE HYDROCHLORIDE 25 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 75834-101_140f2f13-0223-4de4-a779-02a4bc91afe0 75834-101 HUMAN OTC DRUG Psoriatar (Coal Tar) Coal Tar AEROSOL, FOAM TOPICAL 20160515 OTC MONOGRAPH FINAL part358H Nivagen Pharmaceuticals, Inc. COAL TAR 20 mg/g E 20171231 75834-102_103b4cf1-4b5d-44b3-89e2-a393ef4f2276 75834-102 HUMAN PRESCRIPTION DRUG Benzphetamine Hydrochloride Benzphetamine Hydrochloride TABLET ORAL 20160115 ANDA ANDA040747 Nivagen Pharmaceuticals, Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 75834-103_40fe06c1-469c-4662-8555-c84e708d91d5 75834-103 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20161219 ANDA ANDA207938 Nivagen Pharmaceuticals, Inc PIROXICAM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 75834-104_40fe06c1-469c-4662-8555-c84e708d91d5 75834-104 HUMAN PRESCRIPTION DRUG Piroxicam Piroxicam CAPSULE ORAL 20161219 ANDA ANDA207938 Nivagen Pharmaceuticals, Inc PIROXICAM 20 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 75834-107_2154c800-0d1a-4b6e-9beb-d01a8aff26c8 75834-107 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20161017 ANDA ANDA207309 Nivagen Pharmaceuticals, Inc METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 75834-108_2154c800-0d1a-4b6e-9beb-d01a8aff26c8 75834-108 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 20161017 ANDA ANDA207309 Nivagen Pharmaceuticals, Inc METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 75834-112_3be056df-d42a-4c7e-bdca-8c0ac43f6bab 75834-112 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN TABLET, COATED ORAL 20160715 ANDA ANDA091656 Nivagen Pharmaceuticals, Inc. OFLOXACIN 400 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 75834-113_385945af-2042-4312-8918-b04df4bb2df1 75834-113 HUMAN OTC DRUG Lidocaine Lidocaine CREAM TOPICAL 20161215 OTC MONOGRAPH FINAL part346 Nivagen Pharmaceuticals, Inc. LIDOCAINE 50 mg/g E 20171231 75834-115_7ef448bd-1974-4520-9fb0-551f0cd8a541 75834-115 HUMAN PRESCRIPTION DRUG Drospirenone and Ethinyl Estradiol Drospirenone and Ethinyl Estradiol KIT 20171101 ANDA ANDA202015 Nivagen Pharmaceuticals, Inc. N 20181231 75834-116_c3c34de7-6248-45bd-9d70-301e2d5df392 75834-116 HUMAN PRESCRIPTION DRUG Drospirenone and ethinyl estradiol Drospirenone and ethinyl estradiol KIT 20170815 ANDA ANDA202016 Nivagen Pharmaceuticals, Inc. N 20181231 75834-119_3be056df-d42a-4c7e-bdca-8c0ac43f6bab 75834-119 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN TABLET, COATED ORAL 20160715 ANDA ANDA091656 Nivagen Pharmaceuticals, Inc. OFLOXACIN 300 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 75834-120_3be056df-d42a-4c7e-bdca-8c0ac43f6bab 75834-120 HUMAN PRESCRIPTION DRUG OFLOXACIN OFLOXACIN TABLET, COATED ORAL 20160715 ANDA ANDA091656 Nivagen Pharmaceuticals, Inc. OFLOXACIN 200 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 75834-122_903fca8c-4f93-40e4-b92d-d7b66dbf955e 75834-122 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20161015 ANDA ANDA202168 Nivagen Pharmaceuticals, Inc. ACYCLOVIR 400 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 75834-123_903fca8c-4f93-40e4-b92d-d7b66dbf955e 75834-123 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir TABLET ORAL 20161015 ANDA ANDA202168 Nivagen Pharmaceuticals, Inc. ACYCLOVIR 800 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] N 20181231 75834-124_7182581c-d8b6-4248-9484-b769a75d1e2b 75834-124 HUMAN PRESCRIPTION DRUG Acyclovir Acyclovir CAPSULE ORAL 20161015 ANDA ANDA201445 Nivagen Pharmaceuticals, Inc. ACYCLOVIR 200 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 75834-126_cb49f9a0-a6bd-4277-9787-325a3c8fb2e3 75834-126 HUMAN PRESCRIPTION DRUG Hydralazine HYDRALAZINE HYDROCHLORIDE TABLET ORAL 20170215 ANDA ANDA203845 Nivagen Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 75834-127_cb49f9a0-a6bd-4277-9787-325a3c8fb2e3 75834-127 HUMAN PRESCRIPTION DRUG Hydralazine HYDRALAZINE HYDROCHLORIDE TABLET ORAL 20170215 ANDA ANDA203845 Nivagen Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 75834-128_cb49f9a0-a6bd-4277-9787-325a3c8fb2e3 75834-128 HUMAN PRESCRIPTION DRUG Hydralazine HYDRALAZINE HYDROCHLORIDE TABLET ORAL 20170215 ANDA ANDA203845 Nivagen Pharmaceuticals, Inc. HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 75834-129_2a5bf7b7-2dad-4e30-8934-3a9af468b630 75834-129 HUMAN PRESCRIPTION DRUG Norethindrone Acetate and Ethinyl Estradiol Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20161125 ANDA ANDA203435 Nivagen Pharmaceuticals, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL .5; .0025 mg/1; mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 75834-130_2a5bf7b7-2dad-4e30-8934-3a9af468b630 75834-130 HUMAN PRESCRIPTION DRUG Norethindrone Acetate and Ethinyl Estradiol Norethindrone Acetate and Ethinyl Estradiol TABLET ORAL 20161125 ANDA ANDA203435 Nivagen Pharmaceuticals, Inc. NORETHINDRONE ACETATE; ETHINYL ESTRADIOL 1; .005 mg/1; mg/1 Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 75834-131_51d09426-284d-4fa9-be2b-851f9348ef34 75834-131 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET ORAL 20170215 ANDA ANDA203266 Nivagen Pharmaceuticals, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 75834-133_1fcff583-3008-4d25-8fb4-c09454797304 75834-133 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20170904 ANDA ANDA203844 Nivagen Pharmaceuticals, Inc. RIVASTIGMINE TARTRATE 1.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 75834-134_1fcff583-3008-4d25-8fb4-c09454797304 75834-134 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20170904 ANDA ANDA203844 Nivagen Pharmaceuticals, Inc. RIVASTIGMINE TARTRATE 3 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 75834-135_1fcff583-3008-4d25-8fb4-c09454797304 75834-135 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20170904 ANDA ANDA203844 Nivagen Pharmaceuticals, Inc. RIVASTIGMINE TARTRATE 4.5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 75834-136_1fcff583-3008-4d25-8fb4-c09454797304 75834-136 HUMAN PRESCRIPTION DRUG RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE ORAL 20170904 ANDA ANDA203844 Nivagen Pharmaceuticals, Inc. RIVASTIGMINE TARTRATE 6 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 75834-141_d9f32fcc-c274-42a1-8737-f05cd391150d 75834-141 HUMAN OTC DRUG Lidocaine Lidocaine CREAM TOPICAL 20161215 OTC MONOGRAPH FINAL part346 Nivagen Pharmaceuticals, Inc. LIDOCAINE 50 mg/g N 20181231 75834-148_2fd3c2dc-b991-454e-aa15-2f9cc1b1da9d 75834-148 HUMAN PRESCRIPTION DRUG Fluoxetine FLUOXETINE HYDROCHLORIDE TABLET ORAL 20171211 ANDA ANDA209695 Nivagen Pharmaceuticals, Inc. FLUOXETINE HYDROCHLORIDE 60 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 75834-500_d01b63e6-70e5-4679-b377-1e0fb78a87b5 75834-500 HUMAN PRESCRIPTION DRUG Metformin hydrochloride ER Metformin hydrochloride TABLET, EXTENDED RELEASE ORAL 20131101 ANDA ANDA201991 Nivagen Pharmaceuticals Inc METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 75840-093_9dd6b162-d299-4403-a262-f5554162f046 75840-093 HUMAN PRESCRIPTION DRUG SanaDermRx SKin Repair Triamcinolone Acetonide Cream Kit KIT 20151001 ANDA ANDA040671 GenPak Solutions, LLC N 20181231 75840-094_ef2630bb-f9b6-4570-8bf0-4d4add128f9b 75840-094 HUMAN PRESCRIPTION DRUG PrevidolRx Analgesic Pak DICLOFENAC SODIUM KIT 20151215 ANDA ANDA077863 GenPak Solutions, LLC N 20181231 75840-095_b0e3b0cb-0024-4aa3-a275-fe0982d6f9e7 75840-095 HUMAN PRESCRIPTION DRUG PrevidolRx Plus Analgesic Pak DICLOFENAC SODIUM KIT 20151215 ANDA ANDA077863 GenPak Solutions, LLC N 20181231 75840-111_72b163e6-9f58-44a0-bc51-a804036b7da1 75840-111 HUMAN PRESCRIPTION DRUG METHOTREXATE SODIUM METHOTREXATE SODIUM TABLET ORAL 20121001 NDA NDA008085 GenPak Solutions LLC METHOTREXATE SODIUM 2.5 mg/1 Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] N 20181231 75847-1001_5c6847fd-3b32-40e6-abb5-f1f3e11d89ac 75847-1001 HUMAN OTC DRUG IASO A5 Super Brightening Formula adenosine CREAM TOPICAL 20101221 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 mL/mL E 20171231 75847-1101_bd15c5eb-39c0-4979-b7e6-d7dd9ab9ffb3 75847-1101 HUMAN OTC DRUG IASO Triple Protection BB SPF 30 PA adenosine CREAM TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 g/g E 20171231 75847-1201_ed11f3a1-8584-4e43-b79d-17dc6429e883 75847-1201 HUMAN OTC DRUG IASO White Science EX arbutin CREAM TOPICAL 20110117 UNAPPROVED DRUG OTHER IASO Inc ARBUTIN .02 g/g E 20171231 75847-1301_9720729f-47e0-479b-ad55-08c1366e4369 75847-1301 HUMAN OTC DRUG IASO White Science EX Emulsion arbutin CREAM TOPICAL 20110117 UNAPPROVED DRUG OTHER IASO Inc ARBUTIN .02 mL/mL E 20171231 75847-1401_ed75ab89-aa3c-4c75-bf9e-159a1857846f 75847-1401 HUMAN OTC DRUG IASO White Science EX Serum LEVOMENOL LIQUID TOPICAL 20110205 UNAPPROVED DRUG OTHER IASO Inc LEVOMENOL .02 mL/mL E 20171231 75847-1501_006b6bec-4fb2-4188-9fd2-8c54db8aa352 75847-1501 HUMAN OTC DRUG IASO White Science EX Toner LEVOMENOL LIQUID TOPICAL 20110201 UNAPPROVED DRUG OTHER IASO Inc LEVOMENOL .02 mL/mL E 20171231 75847-1601_79edf130-0387-43e8-88cc-37279ce90346 75847-1601 HUMAN OTC DRUG DR. IASO OCTINOXATE CREAM TOPICAL 20120617 UNAPPROVED DRUG OTHER IASO Inc OCTINOXATE 7.5 mL/100mL E 20171231 75847-1701_6ab320ac-2c9c-4a16-9315-80681ed28a92 75847-1701 HUMAN OTC DRUG IASO FOR MEN WHITE EX AFTER SHAVE SUPREME GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .01 g/mL E 20171231 75847-1702_9edb2caa-4c8f-44f5-b101-4ad20c913198 75847-1702 HUMAN OTC DRUG IASO FOR MEN WHITE EX SUPREME GLYCERIN EMULSION TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .034 g/mL E 20171231 75847-1703_30b297ec-0c15-421f-98cf-2293feb9e526 75847-1703 HUMAN OTC DRUG IASO FOR MEN WHITE EX 2-IN-1 FLUID SUPREME GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .0001 g/mL E 20171231 75847-1704_e2abcffc-1fde-41fe-8b5d-9847fbe5ba35 75847-1704 HUMAN OTC DRUG DR.ISAO VITA WHITE SERUM GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .0125 g/mL E 20171231 75847-1705_71969c3b-0b4f-4c23-9b56-75f1a1a1608e 75847-1705 HUMAN OTC DRUG DR. IASO VITA WHITE GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .04 g/mL E 20171231 75847-1706_f19ab15f-f0e4-4fdb-bd0a-8c096c3e1c60 75847-1706 HUMAN OTC DRUG IASO PROGRESSIVE AGE CARE GLYCERIN EMULSION TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .02 g/mL E 20171231 75847-1707_2056a221-1ca5-47e1-8bb9-e600f5b71d6a 75847-1707 HUMAN OTC DRUG IASO INTENSIVE CLEAR CONDITIONER GLYCERIN LIQUID TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .04 g/mL E 20171231 75847-1708_fae69e61-0191-46cc-a5f9-778caa7b872d 75847-1708 HUMAN OTC DRUG DR. IASO UV TOTAL BASE SPF 46 PA GLYCERIN CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc GLYCERIN .05 g/mL E 20171231 75847-1709_5b2ceff6-9a86-49f2-b625-792877a965c2 75847-1709 HUMAN OTC DRUG IASO SMART POWDER PACT 23 ZINC OXIDE POWDER TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc ZINC OXIDE .0291 g/g E 20171231 75847-1710_9b23a5b6-e517-4d48-ab01-f4ae9b303fe8 75847-1710 HUMAN OTC DRUG IASO COVER VEIL PACT 25 ZINC OXIDE POWDER TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc ZINC OXIDE .0192 g/g E 20171231 75847-1711_aa3ab49e-639f-489e-b81f-c5b47d4a550b 75847-1711 HUMAN OTC DRUG DR. IASO POWER 23 ZINC OXIDE POWDER TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc ZINC OXIDE .0192 g/g E 20171231 75847-1712_b5b5a81c-1281-465a-ae1a-99c765e3a3ee 75847-1712 HUMAN OTC DRUG IASO CONTROL MAKE UP BASE 60 ZINC OXIDE CREAM TOPICAL 20130801 OTC MONOGRAPH FINAL part347 IASO Inc ZINC OXIDE .03 g/mL E 20171231 75847-1713_404685fb-9b4b-1fe1-e054-00144ff8d46c 75847-1713 HUMAN OTC DRUG DR. IASO AC BOOSTER Salicylic acid LIQUID TOPICAL 20160801 UNAPPROVED DRUG OTHER IASO Inc SALICYLIC ACID .3 g/10mL N 20181231 75847-2001_c8ed08fe-de32-44c6-a686-eba3fc2e30a0 75847-2001 HUMAN OTC DRUG IASO progressive age care toner adenosine LIQUID TOPICAL 20110101 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 mL/mL E 20171231 75847-3001_e72531f1-c2e3-4596-b2c9-e31fd722660e 75847-3001 HUMAN OTC DRUG IASO progressive age care emulsion adenosine CREAM TOPICAL 20110101 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 mL/mL E 20171231 75847-4001_c98edb97-8e71-4dd1-b50e-4461b7a1fe06 75847-4001 HUMAN OTC DRUG IASO progressive age care serum adenosine CREAM TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 mL/mL E 20171231 75847-5001_31f2c9fe-815b-42f2-921e-dce31ec19494 75847-5001 HUMAN OTC DRUG IASO progressive age care adenosine CREAM TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 g/g E 20171231 75847-6001_0141eb71-343e-4160-88c3-a4a3f932bb4a 75847-6001 HUMAN OTC DRUG IASO Pregressive Age Care Eye adenosine CREAM TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc ADENOSINE .0004 g/g E 20171231 75847-7001_e980c0b9-df77-4852-858d-7b6fbe7ffe35 75847-7001 HUMAN OTC DRUG IASO Intensive Clear Booster SALICYLIC ACID LIQUID TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc SALICYLIC ACID .003 mL/mL E 20171231 75847-8001_3373c99e-1329-41c1-8fc4-2cad5888ed8e 75847-8001 HUMAN OTC DRUG IASO Intensive Clear Conditioner salicylic acid LIQUID TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc SALICYLIC ACID .0001 mL/mL E 20171231 75847-9001_2a06053b-f263-4dde-ba43-b3726d721eaa 75847-9001 HUMAN OTC DRUG UV Shield SPF 42 OCTINOXATE LIQUID TOPICAL 20110109 UNAPPROVED DRUG OTHER IASO Inc OCTINOXATE .075 mL/mL E 20171231 75849-100_8e47d845-a8ab-4e13-8b1d-f2b3638ca960 75849-100 HUMAN OTC DRUG Valtrum US Soothing Topical Analgesic CAMPHOR (SYNTHETIC), MENTHOL OINTMENT TOPICAL 20110309 OTC MONOGRAPH FINAL part348 Laboratorios Quantium LLC CAMPHOR (SYNTHETIC); MENTHOL 3; 3 g/100g; g/100g N 20181231 75849-200_60e24f24-8003-768a-e053-2a91aa0a7037 75849-200 HUMAN OTC DRUG Valtrum US Aerobic Sport IMMEDIATE ACTION CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE LIQUID TOPICAL 20130606 OTC MONOGRAPH NOT FINAL part348 Laboratorios Quantium LLC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 2.5; 2.5; 10 g/100g; g/100g; g/100g N 20181231 75849-300_60e24f24-7fcf-768a-e053-2a91aa0a7037 75849-300 HUMAN OTC DRUG Valtrum Soothing Topical Analgesic CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE OINTMENT TOPICAL 20151112 OTC MONOGRAPH NOT FINAL part348 Laboratorios Quantium LLC CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 25; 25; 100 mg/g; mg/g; mg/g N 20181231 75854-102_638891bb-bf84-a868-e053-2a91aa0ab2cf 75854-102 HUMAN PRESCRIPTION DRUG Ana-Lex hydrocortisone acetate and lidocaine hydrochloride CREAM TOPICAL 20080228 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE 20; 20 mg/g; mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20191231 75854-306_620b81eb-87c8-7acd-e053-2991aa0ac6e8 75854-306 HUMAN PRESCRIPTION DRUG Prenate Chewable calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry TABLET, CHEWABLE ORAL 20130116 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC CALCIUM CARBONATE; CHOLECALCIFEROL; MAGNESIUM OXIDE; BORON; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; BILBERRY 500; 300; 50; 250; 1; 10; 125; 280; 25 mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20191231 75854-307_620b16ea-7269-2c3c-e053-2a91aa0a61cf 75854-307 HUMAN PRESCRIPTION DRUG Prenate AM .pyridoxine hydrochloride, cyanocobalamin, calcium carbonate and folic acid TABLET, COATED ORAL 20130615 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM CARBONATE; FOLIC ACID 75; 12; 200; 1 mg/1; ug/1; mg/1; mg/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20191231 75854-308_620b81eb-87d6-7acd-e053-2991aa0ac6e8 75854-308 HUMAN PRESCRIPTION DRUG PRENATE Restore ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent CAPSULE, GELATIN COATED ORAL 20130917 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS FUMARATE; MAGNESIUM OXIDE; LACTIC ACID; DOCONEXENT 85; 1000; 10; 1; 25; 12; 500; 155; 27; 45; 10; 400 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 75854-309_620bb039-d242-a3fb-e053-2a91aa0acc84 75854-309 HUMAN PRESCRIPTION DRUG PRENATE Enhance ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent CAPSULE, GELATIN COATED ORAL 20130917 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT 85; 1000; 10; 1; 25; 12; 500; 155; 28; 150; 50; 400 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient] N 20191231 75854-312_620bb039-d220-a3fb-e053-2a91aa0acc84 75854-312 HUMAN PRESCRIPTION DRUG PRENATE DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium formate, ferrous asparto glycinate, magnesium oxide and doconexent CAPSULE, GELATIN COATED ORAL 20140605 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; MAGNESIUM OXIDE; DOCONEXENT 90; 400; 40; 1; 26; 25; 155; 18; 50; 300 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 75854-313_620bd91c-37d9-6b93-e053-2a91aa0ad872 75854-313 HUMAN PRESCRIPTION DRUG Prenate Essential ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent CAPSULE, GELATIN COATED ORAL 20140718 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; 5-METHYLTETRAHYDROFOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; ICOSAPENT 90; 220; 10; 26; 400; 600; 13; 280; 155; 18; 150; 50; 300; 40 mg/1; [iU]/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20191231 75854-314_620bb039-d233-a3fb-e053-2a91aa0acc84 75854-314 HUMAN PRESCRIPTION DRUG Prenate Elite .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, calcium formate, ferrous asparto glycinate, cyanocobalamin, biotin, potassium iodide, magnesium oxide, zinc oxide and cupric oxide TABLET, COATED ORAL 20140605 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; 5-METHYLTETRAHYDROFOLIC ACID; CALCIUM FORMATE; FERROUS ASPARTO GLYCINATE; CYANOCOBALAMIN; BIOTIN; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE 2600; 75; 600; 40; 3; 3.5; 21; 21; 400; 600; 155; 20; 13; 330; 150; 25; 15; 1.5 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] N 20191231 75854-315_620bdc84-5c5f-2c39-e053-2991aa0a099f 75854-315 HUMAN PRESCRIPTION DRUG Prenate Mini ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium carbonate, ferrous asparto glycinate, iron, potassium iodide, magnesium oxide, doconexent and lowbush blueberry CAPSULE, GELATIN COATED ORAL 20141118 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM CARBONATE; FERROUS ASPARTO GLYCINATE; IRON; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; LOWBUSH BLUEBERRY; LEVOMEFOLIC ACID 60; 1000; 10; 26; 400; 13; 280; 80; 9; 9; 150; 25; 350; 25; 600 mg/1; [iU]/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] N 20191231 75854-316_620bf195-e195-f008-e053-2991aa0ae7d6 75854-316 HUMAN PRESCRIPTION DRUG Prenate Pixie ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry TABLET, FILM COATED ORAL 20140814 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; FERROUS ASPARTO GLYCINATE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; DOCUSATE SODIUM; BLUEBERRY; LEVOMEFOLIC ACID 30; 75; 500; 13; 400; 10; 150; 5; 10; 200; 5; 600 mg/1; ug/1; [iU]/1; ug/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; ug/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] N 20191231 75854-319_672a6fa1-8671-4529-8a61-b5d9292f962d 75854-319 HUMAN PRESCRIPTION DRUG FeRiva FA ferrous bisglycinate, ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, biotin, cupric oxide and docusate sodium CAPSULE, GELATIN COATED ORAL 20141218 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC FERROUS BISGLYCINATE; FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; ASCORBIC ACID; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CUPRIC OXIDE; DOCUSATE SODIUM 36.7; 36.7; 36.7; 175; 1; 12; 300; 1.5; 50 mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 75854-320_ac374bcd-cbeb-4ad3-8d72-a75f72bd1cf4 75854-320 HUMAN PRESCRIPTION DRUG Chromagen ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, zinc, and intrinsic factor CAPSULE ORAL 20170123 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC FERROUS ASPARTO GLYCINATE; FERROUS FUMARATE; ASCORBIC ACID; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; ZINC; INTRINSIC FACTOR 25; 50; 60; 750; 250; 10; 12; 100 mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 75854-321_78267520-cb56-461e-9271-f1ffa21a8b26 75854-321 HUMAN PRESCRIPTION DRUG Niferex ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, succinic acid, and intrinsic factor TABLET ORAL 20170123 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC FERROUS ASPARTO GLYCINATE; IRON DEXTRAN; ASCORBIC ACID; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; ZINC; SUCCINIC ACID; INTRINSIC FACTOR 50; 100; 60; 750; 250; 25; 15; 50; 100 mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1 Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC] N 20181231 75854-322_832667a6-737c-40f8-b1f1-5ed7382562ac 75854-322 HUMAN PRESCRIPTION DRUG PrimaCare calcium ascorbate dihydrate, cholecalciferol, dl-A tocopheryl acetate, riboflavin, niacinamide, Folate, Biotin, calcium, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc bisglycinate chelate, Alpha linoleic acid, DHA, EPA PILL ORAL 20170123 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC CALCIUM ASCORBATE; CHOLECALCIFEROL; ALPHA-TOCOPHEROL ACETATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE; FOLIC ACID; BIOTIN; CALCIUM CARBONATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC; LINOLEIC ACID; OMEGA-3 FATTY ACIDS 25; 1000; 15; 1.5; 10; 50; 1; 1; 100; 150; 50; 15; 50; 420 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC] N 20181231 75854-601_ce17984c-e5d8-4966-a606-f8b7f44b14af 75854-601 HUMAN PRESCRIPTION DRUG Falessa Levonorgestrel and Ethinyl Estradiol KIT 20140217 UNAPPROVED DRUG OTHER Avion Pharmaceuticals, LLC E 20171231 75862-001_f353b745-3138-4002-be33-7349c31d418f 75862-001 HUMAN OTC DRUG HAND SANITIZING GREEN APPLE ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mL/100mL E 20171231 75862-002_90c44300-4eb7-4718-8255-e98ae56ded19 75862-002 HUMAN OTC DRUG HAND SANITIZING MANDARIN ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mg/100mL E 20171231 75862-003_17989b32-ecb8-49a4-a039-043f67ca1bf9 75862-003 HUMAN OTC DRUG HAND SANITIZING BLUEBERRY ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mg/100mL E 20171231 75862-004_14e3e0f4-67ee-416d-b7cc-a4effcc288b4 75862-004 HUMAN OTC DRUG HAND SANITIZING STRAWBERRY ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mL/100mL E 20171231 75862-005_52c97bfd-76fe-42d1-96cb-3d3a3055ed08 75862-005 HUMAN OTC DRUG HAND SANITIZING UNSCENTED ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mg/100mL E 20171231 75862-006_b2aaf77a-6927-4d65-b17d-8f7640bbb911 75862-006 HUMAN OTC DRUG HAND SANITIZING SPECIAL TEACHER GREEN APPLE ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mg/100mL E 20171231 75862-007_5ce9138b-6c0c-49af-8aa5-0893fe4b753c 75862-007 HUMAN OTC DRUG HAND SANITIZING TEACHERS RULE MANDARIN ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mg/mL E 20171231 75862-008_919344a2-c303-4edf-b161-340a0b5f8fcb 75862-008 HUMAN OTC DRUG HAND SANITIZING A PLUS TEACHER UNSCENTED ALCOHOL GEL TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC ALCOHOL 62 mg/100mL E 20171231 75862-009_3ebba235-a0a8-4f0d-bd1a-44529a6229bf 75862-009 HUMAN OTC DRUG BIRDS GARDEN LIP BALM CERULEAN WARBLER SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 7.5; 7; 5; 5 g/100g; g/100g; g/100g; g/100g E 20171231 75862-010_323ed60f-0a71-4cf6-b794-3b43ca8a74e4 75862-010 HUMAN OTC DRUG BIRDS GARDEN LIP BALM WESTERN TANAGER - SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 7.5; 7; 5; 5 g/100g; g/100g; g/100g; g/100g E 20171231 75862-011_dd48e273-44e3-48cd-b59d-ac34723d68e5 75862-011 HUMAN OTC DRUG BIRDS GARDEN LIP BALM DARK EYED JUNCO SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 7.5; 7; 5; 5 g/100g; g/100g; g/100g; g/100g E 20171231 75862-012_c0595792-471f-43c5-985b-8074f12a9c9f 75862-012 HUMAN OTC DRUG Lip Remedy Medicinal Lip Balm BLUE PETROLATUM STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part346 GANZ U.S.A., LLC PETROLATUM 32.3 g/100g E 20171231 75862-013_c0595792-471f-43c5-985b-8074f12a9c9f 75862-013 HUMAN OTC DRUG Lip Remedy Medicinal Lip Balm GREEN PETROLATUM STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part346 GANZ U.S.A., LLC PETROLATUM 32.3 g/100g E 20171231 75862-014_c0595792-471f-43c5-985b-8074f12a9c9f 75862-014 HUMAN OTC DRUG Lip Remedy Medicinal Lip Balm RED PETROLATUM STICK TOPICAL 20110201 OTC MONOGRAPH FINAL part346 GANZ U.S.A., LLC PETROLATUM 32.3 g/100g E 20171231 75862-015_7520e137-ca8e-4dcd-af38-79a2f74a6175 75862-015 HUMAN OTC DRUG Sun-Kissed Lip Balm Lemon Lime SPF30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 7.5; 7; 5; 5 g/100g; g/100g; g/100g; g/100g E 20171231 75862-016_7520e137-ca8e-4dcd-af38-79a2f74a6175 75862-016 HUMAN OTC DRUG Kiss and Shield Lip Balm Lemon Lime SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 7.5; 7; 5; 5 g/100g; g/100g; g/100g; g/100g E 20171231 75862-017_7520e137-ca8e-4dcd-af38-79a2f74a6175 75862-017 HUMAN OTC DRUG Inspired by Color Lemon Lime SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 7.5; 7; 5; 5 g/100g; g/100g; g/100g; g/100g E 20171231 75862-018_8eeb92ef-bf4c-436e-a70c-2538df88cb72 75862-018 HUMAN OTC DRUG FOR THE GARDENER LIP BALM SPF 30 OCTINOXATE, OCTOCRYLENE, OCTISALATE, and OXYBENZONE STICK TOPICAL 20110810 OTC MONOGRAPH NOT FINAL part352 GANZ U.S.A., LLC OCTINOXATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE 7.5; 7; 5; 5 g/100g; g/100g; g/100g; g/100g E 20171231 75862-019_fb6e2d48-8b3b-4062-b097-9fbea6ce07d5 75862-019 HUMAN OTC DRUG Gourmet Kitchen Regenerating Anti-Bacterial Fresh Picked Fig Benzalkonium Chloride LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 75862-020_f3f77dcc-d5d4-4f76-897e-3d3461ca3758 75862-020 HUMAN OTC DRUG Teacher Collection Anti Bacterial Country Apple Benzalkonium Chloride LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 75862-021_f3f77dcc-d5d4-4f76-897e-3d3461ca3758 75862-021 HUMAN OTC DRUG Teacher Collection Anti Bacterial Sweet Apple Benzalkonium Chloride LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 75862-022_f3f77dcc-d5d4-4f76-897e-3d3461ca3758 75862-022 HUMAN OTC DRUG Teacher Collection Anti Bacterial Delicious Apple Benzalkonium Chloride LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 75862-023_fb6e2d48-8b3b-4062-b097-9fbea6ce07d5 75862-023 HUMAN OTC DRUG Gourmet Kitchen Regenerating Anti-Bacterial Sweet Plum Benzalkonium Chloride LOTION TOPICAL 20111130 OTC MONOGRAPH NOT FINAL part333E GANZ U.S.A., LLC BENZALKONIUM CHLORIDE .1 g/100mL E 20171231 75863-1001_9b0f7b93-3696-4db4-b00c-96485c926739 75863-1001 HUMAN OTC DRUG Cheongin Samrakhwan lactic acid PELLET ORAL 20110217 UNAPPROVED DRUG OTHER Entechbio Co., Ltd LACTIC ACID .001 g/g E 20171231 75863-2001_8bc8211c-e3b9-4815-865d-3719847b1220 75863-2001 HUMAN OTC DRUG Cheongin Haejanghwan lactic acid PELLET ORAL 20110218 UNAPPROVED DRUG OTHER Entechbio Co., Ltd LACTIC ACID .001 g/g E 20171231 75863-3001_b9ee848e-2150-4024-8d9f-0c48744f8ffb 75863-3001 HUMAN OTC DRUG Cheongin Haewoohwan lactic acid PELLET ORAL 20110218 UNAPPROVED DRUG OTHER Entechbio Co., Ltd LACTIC ACID .001 g/g E 20171231 75866-001_c8d3457f-68cb-43ce-9a38-0a5bccae280f 75866-001 HUMAN OTC DRUG Antibacterial Hand Cleanser, Non-Alcohol BENZALKONIUM CHLORIDE GEL TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part333E Beacon Promotions BENZALKONIUM CHLORIDE 1 mg/mL E 20171231 75866-301_1f7524e4-1a47-4f7b-87f2-697ffc1edf8a 75866-301 HUMAN OTC DRUG Bubble Gum Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g E 20171231 75866-302_7fe3037a-97f1-4c59-bd0b-69a975db8ab3 75866-302 HUMAN OTC DRUG Coconut Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions, Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g E 20171231 75866-303_284ce01e-75d3-46b1-a932-a921c7b69d98 75866-303 HUMAN OTC DRUG Cotton Candy Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions, Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g E 20171231 75866-304_014af8a3-f126-435e-9b05-83bbdcec8c53 75866-304 HUMAN OTC DRUG Mint Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions, Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g E 20171231 75866-305_94cf85f0-6f27-4f43-8912-63b594cbb5d2 75866-305 HUMAN OTC DRUG Pineapple Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions, Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g E 20171231 75866-306_6e0e43bf-2b0a-49d6-aef1-4a7db3d07ae4 75866-306 HUMAN OTC DRUG Strawberry Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions, Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g E 20171231 75866-307_c2ffc690-8b5b-41d5-8587-47dae254ad9c 75866-307 HUMAN OTC DRUG Vanilla Sunscreen Lip Moisturizer OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20101229 OTC MONOGRAPH NOT FINAL part352 Beacon Promotions, Inc. OCTINOXATE; OXYBENZONE 7; 3 g/100g; g/100g E 20171231 75870-001_213c1e4e-5d9d-4b58-8bdf-f5813719ed4e 75870-001 HUMAN OTC DRUG LIFT THERAPY FORCE LIFT DAY 20 SPF OCTOCRYLENE, COTINOXATE, AVOBENZONE CREAM TOPICAL 20110115 OTC MONOGRAPH NOT FINAL part352 LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA OCTOCRYLENE; OCTINOXATE; AVOBENZONE 5; 3.75; 1.75 mL/50mL; mL/50mL; mL/50mL E 20171231 75870-002_debf540c-ac04-4732-8ea1-9b1f1c2793e4 75870-002 HUMAN OTC DRUG SOFT DERM INTENSIVE DEFENSE 8 SPF OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20070701 OTC MONOGRAPH NOT FINAL part352 LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA OCTINOXATE; TITANIUM DIOXIDE 10; 7.045 mL/50mL; mL/50mL E 20171231 75870-003_2d837941-c926-4706-b5c1-fe44ab27d103 75870-003 HUMAN OTC DRUG DESPIGMEN PROTECTIVE 25 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20070701 OTC MONOGRAPH NOT FINAL part352 LABORATORIOS DE COSMETICA SCIENTIFICA AT OCTINOXATE; TITANIUM DIOXIDE 3; .88 mL/50mL; mL/50mL E 20171231 75870-006_c2955e48-40cc-433b-ba15-3228a0c6fdc9 75870-006 HUMAN OTC DRUG SUN PREMIUM FACE 50 SPF OXYBENZONE, OCTINOXATE, AVOBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20070515 OTC MONOGRAPH NOT FINAL part352 LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA OXYBENZONE; OCTINOXATE; AVOBENZONE; TITANIUM DIOXIDE 3.75; 3.75; 1.5; 1.185 mL/75mL; mL/75mL; mL/75mL; mL/75mL E 20171231 75870-007_ec831854-bda7-467b-b309-ed1519b1ea7e 75870-007 HUMAN OTC DRUG Oily SK Specific Solutions SALICYLIC ACID GEL TOPICAL 20080715 OTC MONOGRAPH FINAL part333D LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SALICYLIC ACID .06 mL/15mL E 20171231 75870-008_dd76ce3c-1349-4357-912c-be7fca98c83d 75870-008 HUMAN OTC DRUG Oily SK Cleansing SALICYLIC ACID GEL TOPICAL 20080715 OTC MONOGRAPH FINAL part333D LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SALICYLIC ACID 1.15 mL/115mL E 20171231 75870-009_3d1c0612-3dc2-40b1-ac4c-18bbebac7b07 75870-009 HUMAN OTC DRUG Oily SK Balancing I SALICYLIC ACID CREAM TOPICAL 20070715 OTC MONOGRAPH FINAL part333D LABORATORIOS DE COSMETICA SCIENTIFI SALICYLIC ACID .5 mL/50mL E 20171231 75874-424_6e73b170-b84e-4e37-ac0f-7ba7f60c057f 75874-424 HUMAN PRESCRIPTION DRUG Indocyanine green Indocyanine green INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20111201 ANDA ANDA040811 Novadaq Technologies Inc. INDOCYANINE GREEN 25 mg/1 Diagnostic Dye [EPC],Dyes [MoA] E 20171231 75874-701_368890cf-c636-473b-9894-9982dcf6d49f 75874-701 HUMAN PRESCRIPTION DRUG IC-Green Indocyanine Green INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20130915 NDA NDA011525 Novadaq Technologies Inc. INDOCYANINE GREEN 25 mg/1 N 20181231 75874-820_6e73b170-b84e-4e37-ac0f-7ba7f60c057f 75874-820 HUMAN PRESCRIPTION DRUG Indocyanine green Indocyanine green KIT 19810720 ANDA ANDA040811 Novadaq Technologies Inc. E 20171231 75878-001_03212fb9-b67c-4098-8a76-8fd8c0d51e51 75878-001 HUMAN OTC DRUG Raggedy Ann and Andy Cotton Candy Triclosan SOAP TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part333E My Habitat Brands LLC TRICLOSAN .002 g/mL E 20171231 75878-002_8c997368-03bc-4552-bc8d-ea0c2f161141 75878-002 HUMAN OTC DRUG Raggedy Ann and Andy Tropical Breeze Triclosan SOAP TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part333E My Habitat Brands LLC TRICLOSAN .002 g/mL E 20171231 75878-003_5ea32d43-20f9-4459-80c3-5a5a42d9778f 75878-003 HUMAN OTC DRUG Raggedy Ann and Andy Foam Vanilla Bean Benzalkonium Chloride SOAP TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part333E My Habitat Brands LLC BENZALKONIUM CHLORIDE .0013 g/mL E 20171231 75878-004_9dde556e-a098-46da-a4b3-d60b3ea6c580 75878-004 HUMAN OTC DRUG Raggedy Ann and Andy Foam Wacky Watermelon Blast Benzalkonium Chloride SOAP TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part333E My Habitat Brands LLC BENZALKONIUM CHLORIDE .0013 g/mL E 20171231 75884-100_792e8ce2-1d3b-4edd-a6cb-7bd637db02be 75884-100 HUMAN OTC DRUG Halsa Pyrithione Zinc Dandruff PYRITHIONE ZINC SHAMPOO TOPICAL 20101215 OTC MONOGRAPH FINAL part358H Momentum Brands dba 99 Cents Only Stores PYRITHIONE ZINC 1 mL/100mL E 20171231 75884-200_497ba136-6387-4746-be75-a296501006a8 75884-200 HUMAN OTC DRUG Halsa Pyrithione Zinc Dandruff - Dry Scalp Care PYRITHIONE ZINC SHAMPOO TOPICAL 20110107 OTC MONOGRAPH FINAL part358H Momentum Brands dba 99 Cents Only Stores PYRITHIONE ZINC 1 mL/100mL E 20171231 75885-010_cd93b0ad-b8ec-455c-a530-9735905b1d51 75885-010 HUMAN OTC DRUG PUTTO ATO SECRET UV FACE SPF 6 ZINC OXIDE CREAM CUTANEOUS 20100401 OTC MONOGRAPH FINAL part352 AGABANG & COMPANY ZINC OXIDE; TITANIUM DIOXIDE 2.7; 1.34 mL/80mL; mL/80mL E 20171231 75885-020_2a90f358-5079-4c62-ba83-42712f2bc1b5 75885-020 HUMAN OTC DRUG Putto Secret Sun Screen TITANIUM DIOXIDE CREAM TOPICAL 20130713 OTC MONOGRAPH FINAL part352 AGABANG & COMPANY TITANIUM DIOXIDE 6 mg/100mL E 20171231 75885-030_cef50561-35f6-4582-a872-2a9fb67b5a29 75885-030 HUMAN OTC DRUG Putto Secret UV Face TITANIUM DIOXIDE CREAM TOPICAL 20130826 OTC MONOGRAPH FINAL part352 AGABANG & COMPANY TITANIUM DIOXIDE 2.6 mg/100mL E 20171231 75885-040_08b6098d-d9e0-4a06-ad4d-f312635ca155 75885-040 HUMAN OTC DRUG Putto Secret UV Face TITANIUM DIOXIDE CREAM TOPICAL 20130903 OTC MONOGRAPH FINAL part352 AGABANG & COMPANY TITANIUM DIOXIDE 2.96 mg/100mL E 20171231 75887-001_c434da1f-1978-4fb1-a3c2-6cfc97ceb191 75887-001 HUMAN OTC DRUG Hand Sanitizer Anticeptic ALCOHOL GEL TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part333A Aztex Enterprises ALCOHOL 5 mL/8mL E 20171231 75887-002_b04a8c62-4b69-43d1-8429-1531c35076df 75887-002 HUMAN OTC DRUG Lip Balm Unflavored Octinoxate, Octisalate, Oxybenzone STICK TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part352 Aztex Enterprises OCTINOXATE; OCTISALATE; OXYBENZONE .3; .08; .13 g/4.2g; g/4.2g; g/4.2g E 20171231 75887-003_1a05b791-a0ae-48b3-a951-b6928d0bfa44 75887-003 HUMAN OTC DRUG Sunscreen 30 SPF OCTINOXATE, OXYBENZONE LOTION TOPICAL 20110118 OTC MONOGRAPH NOT FINAL part352 Aztex Enterprises OCTINOXATE; OXYBENZONE 22; 16 mL/30mL; mL/30mL E 20171231 75892-001_34838ce0-e96d-495c-a0e3-2204b230ebd9 75892-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20101222 UNAPPROVED MEDICAL GAS Ohio Valley Acquisition Corp dba Ohio Valley Medical Gas & Supply, Inc. OXYGEN 99 L/100L E 20171231 75902-1001_a07e92c3-0b69-4290-bac0-61651c32ac86 75902-1001 HUMAN OTC DRUG Whitening Foaming Sodium fluoride MOUTHWASH DENTAL 20101217 UNAPPROVED DRUG OTHER Dio Corporation SODIUM FLUORIDE; ALLANTOIN .001; .0005 mL/mL; mL/mL N 20181231 75902-2001_96986790-e17a-494c-8008-e60e0702d743 75902-2001 HUMAN OTC DRUG Whitening Foaming-Toothpaste Sodium fluoride GEL, DENTIFRICE DENTAL 20111004 UNAPPROVED DRUG OTHER Dio Corporation SODIUM FLUORIDE; ALLANTOIN .001; .0005 mL/mL; mL/mL N 20181231 75902-3001_50e23c08-730f-6d1a-e054-00144ff8d46c 75902-3001 HUMAN OTC DRUG DIO PORORO KIDS FOAMING Sodium fluoride PASTE, DENTIFRICE DENTAL 20141104 UNAPPROVED DRUG OTHER Dio Corporation SODIUM FLUORIDE; ALLANTOIN .1; .05 g/100mL; g/100mL N 20181231 75902-4001_50e23c08-7305-6d1a-e054-00144ff8d46c 75902-4001 HUMAN OTC DRUG DIO WHITENING Sodium fluoride PASTE, DENTIFRICE DENTAL 20150122 UNAPPROVED DRUG OTHER Dio Corporation SILICON DIOXIDE; .ALPHA.-TOCOPHEROL ACETATE; HYDROGEN PEROXIDE 7; .2; 2.14 g/100g; g/100g; g/100g N 20181231 75902-6001_50e23c08-72fb-6d1a-e054-00144ff8d46c 75902-6001 HUMAN OTC DRUG DIO Enamel Coating Pen Pro Tooth Tricalcium Phosphate, Dental Type Silica, Tocopheryl Acetate PASTE, DENTIFRICE DENTAL 20160501 UNAPPROVED DRUG OTHER Dio Corporation TRICALCIUM PHOSPHATE; .ALPHA.-TOCOPHEROL ACETATE; SILICON DIOXIDE 20; .2; 6 g/100g; g/100g; g/100g N 20181231 75904-3246_5ba9ed70-fdbd-435c-ae6f-b6f14e573bca 75904-3246 HUMAN OTC DRUG CalmaFX Moisture Barrier MENTHOL, CALAMINE, ZINC OXIDE OINTMENT TOPICAL 20110228 OTC MONOGRAPH FINAL part347 First Choice Medical Supply MENTHOL; FERRIC OXIDE RED; ZINC OXIDE 4.5; 20; 180 mg/g; mg/g; mg/g E 20171231 75904-3343_7ea32c8e-f745-4325-a0c2-a891f0f7f55f 75904-3343 HUMAN OTC DRUG PrimaGuard Daily Care Skin Protectant LANOLIN OINTMENT TOPICAL 20110228 OTC MONOGRAPH FINAL part347 First Choice Medical Supply LANOLIN 300 mg/g E 20171231 75908-017_158c8d15-57e2-48e0-9263-f22ab1671533 75908-017 HUMAN OTC DRUG Periogel hydrogen peroxide GEL DENTAL 20110401 OTC MONOGRAPH NOT FINAL part356 QNT Anderson, LLC HYDROGEN PEROXIDE 17 mg/g N 20181231 75913-113_c0a2f539-8c7d-4570-8a92-b4b413e3f101 75913-113 HUMAN PRESCRIPTION DRUG Ammonia N 13 NH3N13 INJECTION INTRAVENOUS 20120320 ANDA ANDA204506 Washington University School of Medicine AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 75913-311_1c0a2b3e-a632-40b2-b87d-f8134ab37d85 75913-311 HUMAN PRESCRIPTION DRUG Choline C 11 Choline C-11 INJECTION INTRAVENOUS 20170110 ANDA ANDA208413 Washington University School of Medicine CHOLINE C-11 33.1 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 75913-647_e39657a5-93f1-40b7-b5b3-a9cdfedafc93 75913-647 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20110102 ANDA ANDA203935 Washington University School of Medicine FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 75916-0634_3a0493c9-c58d-4d92-9345-e0bc231b3763 75916-0634 HUMAN OTC DRUG SnowSkin Sunscreen Zinc OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 2.35; 4.2 g/100g; g/100g; g/100g E 20171231 75916-0635_0c1ac175-0b54-45de-822a-f1d803f53289 75916-0635 HUMAN OTC DRUG GolfersSkin Sunscreen Zinc OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 2.35; 4.2 g/100g; g/100g; g/100g E 20171231 75916-0636_94f4872f-0945-4c31-b37a-b786bffbbc94 75916-0636 HUMAN OTC DRUG SurfersSkin Sunscreen Zinc OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 2.35; 4.2 g/100g; g/100g; g/100g E 20171231 75916-0641_526a2a52-0b3b-4664-816e-537b0783946c 75916-0641 HUMAN OTC DRUG SnowSkin Face Sunscreen OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20110117 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 6; 3.3; 14.25 g/100g; g/100g; g/100g E 20171231 75916-0659_4921d750-f94a-4603-9f5d-15c32b0fe3ef 75916-0659 HUMAN OTC DRUG Snow Skin Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE STICK TOPICAL 20110117 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 2.5; 7.5; 5 g/100g; g/100g; g/100g E 20171231 75916-0660_6d887782-a098-40f7-b9b0-419be858a36a 75916-0660 HUMAN OTC DRUG Surfers Skin Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE STICK TOPICAL 20110117 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 2.5; 7.5; 5 g/100g; g/100g; g/100g E 20171231 75916-0664_6fa34154-3763-4ee4-89c0-49bea4fd9b7e 75916-0664 HUMAN OTC DRUG GolfersSkin Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE STICK TOPICAL 20110119 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 2.5; 7.5; 5 g/100g; g/100g; g/100g E 20171231 75916-3024_1038067f-2930-480b-9f46-a2a528261727 75916-3024 HUMAN OTC DRUG GolfersSkin Face Sunscreen OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 6; 3.3; 14.25 g/100g; g/100g; g/100g E 20171231 75916-3025_238f55ee-7fb7-4121-8260-1d515709712c 75916-3025 HUMAN OTC DRUG SurfersSkin Face Sunscreen OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE STICK TOPICAL 20110127 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE 6; 3.3; 14.25 g/100g; g/100g; g/100g E 20171231 75916-4018_27823bb3-6e22-4736-916c-f5fe060cc499 75916-4018 HUMAN OTC DRUG SnowSkin Sunscreen OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110105 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 3.45; 1; 1.95 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 75916-4019_1bcab3f2-a9fd-4f3a-8f34-528b3223b54c 75916-4019 HUMAN OTC DRUG Surfers Skin Sunscreen OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 7.5; 3.45; 1; 1.95 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 75916-4020_430fa1b2-bb36-4cc9-bc10-08d4e910e4ce 75916-4020 HUMAN OTC DRUG Golfers Skin Broad Spectrum SPF 30 Plus Sunscreen OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110131 OTC MONOGRAPH NOT FINAL part352 Skin Alive, Ltd. OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE 75; 34.5; 10; 19.5 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 75920-0464_527dd364-1f24-48c2-e054-00144ff8d46c 75920-0464 HUMAN OTC DRUG Blowfish Aspirin, Caffeine TABLET, EFFERVESCENT ORAL 20110723 OTC MONOGRAPH NOT FINAL part343 Rally Labs LLC ASPIRIN; CAFFEINE 500; 60 mg/1; mg/1 N 20181231 75921-011_2a7c7458-c134-448b-82c6-011889f2f1f3 75921-011 HUMAN PRESCRIPTION DRUG HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED ORAL 20120118 ANDA ANDA040787 Life Line Home Care Services, Inc. HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] E 20171231 75921-025_19a1ef21-8020-4246-a46c-e0549260f691 75921-025 HUMAN PRESCRIPTION DRUG Phentermine Hydrochloride Phentermine Hydrochloride TABLET ORAL 20080331 ANDA ANDA040876 Life Line Home Care Services, Inc. PHENTERMINE HYDROCHLORIDE 37.5 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIV E 20171231 75921-045_ace35603-63a6-41dc-9dca-a4c05776d2fa 75921-045 HUMAN PRESCRIPTION DRUG Phendimetrazine Tartrate Phendimetrazine Tartrate TABLET ORAL 20100915 ANDA ANDA091042 Life Line Home Care Services, Inc. PHENDIMETRAZINE TARTRATE 35 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII E 20171231 75921-119_3306f31a-bdf7-4ae3-a6e0-b8692b54cfb6 75921-119 HUMAN PRESCRIPTION DRUG Doxycycline Hyclate Doxycycline Hyclate CAPSULE ORAL 20120208 ANDA ANDA062676 Life Line Home Care Services, Inc. DOXYCYCLINE HYCLATE 100 mg/1 E 20171231 75921-121_7b333259-a3e0-4997-9c5b-cf3c7ccf2219 75921-121 HUMAN PRESCRIPTION DRUG MECLIZINE HYDROCHLORIDE Meclizine Hydrochloride TABLET ORAL 20100604 ANDA ANDA040659 Life Line Home Care Services, Inc. MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 75921-125_f55a66b0-c052-46e2-ab65-89a43f304aa5 75921-125 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20060807 ANDA ANDA077927 Life Line Home Care Services, Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 75921-130_8f681b23-29c3-4b42-98e2-71306ca9716d 75921-130 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE ORAL 20120208 ANDA ANDA090510 Life Line Home Care Services, Inc. HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 75921-133_c9134869-a1de-44e6-9843-f9d1c576846c 75921-133 HUMAN PRESCRIPTION DRUG BENZONATATE BENZONATATE CAPSULE ORAL 20120112 ANDA ANDA040587 Life Line Home Care Services, Inc. BENZONATATE 100 mg/1 Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC] E 20171231 75921-158_afb09fe8-8038-49ff-b492-d5780171df80 75921-158 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20120229 ANDA ANDA075576 Life Line Home Care Services, Inc. OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 75921-190_a6a104e3-e634-4f9d-bdfb-33b429b8de1b 75921-190 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20100218 ANDA ANDA075927 Life Line Home Care Services, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 75921-200_d0676c30-33fe-46f3-995b-9116c6cc106a 75921-200 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20061220 ANDA ANDA077752 Life Line Home Care Services, Inc. SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 75921-208_396aa302-3785-46a0-8369-256f458ebcd3 75921-208 HUMAN PRESCRIPTION DRUG VALACYCLOVIR HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE TABLET, COATED ORAL 20100524 ANDA ANDA077478 Life Line Home Care Services, Inc. VALACYCLOVIR HYDROCHLORIDE 500 mg/1 DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient] E 20171231 75921-241_11adb6a6-f550-4c38-96c4-4092bc84d956 75921-241 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam TABLET ORAL 19911031 ANDA ANDA072927 Life Line Home Care Services, Inc. LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 75921-397_7a705103-c019-47c8-b0b3-014fade00636 75921-397 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride metformin hydrochloride TABLET ORAL 20020130 ANDA ANDA075967 Life Line Home Care Services, Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 75921-402_b95a1e89-9d39-4267-af6f-3a8642043685 75921-402 HUMAN OTC DRUG Cetirizine Cetirizine Hydrochloride TABLET ORAL 20120203 ANDA ANDA077829 Life Line Home Care Services, Inc. CETIRIZINE HYDROCHLORIDE 10 mg/1 E 20171231 75921-409_355eb776-d27a-400f-a07c-073f581c69ee 75921-409 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET ORAL 20101006 ANDA ANDA090467 Life Line Home Care Services, Inc. LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 75921-412_17081ef1-c58a-47fc-9683-d9b6776234f8 75921-412 HUMAN PRESCRIPTION DRUG ciprofloxacin ciprofloxacin TABLET ORAL 20120206 ANDA ANDA076639 Life Line Home Care Services, Inc. CIPROFLOXACIN HYDROCHLORIDE 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 75921-438_c6ca168c-85f1-4654-9f6e-2f82f44ee87e 75921-438 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20060718 ANDA ANDA040622 Life Line Home Care Services, Inc. PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 75921-459_0e655e4b-acb1-4326-8204-44c406a0c4eb 75921-459 HUMAN PRESCRIPTION DRUG Ondansetron Ondansetron TABLET, FILM COATED ORAL 20070625 ANDA ANDA077851 Life Line Home Care Services, Inc. ONDANSETRON HYDROCHLORIDE 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] E 20171231 75921-466_52cab568-ce9d-4005-bcb0-b30bb539787e 75921-466 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20120213 ANDA ANDA078558 Life Line Home Care Services, Inc. IBUPROFEN 800 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 75921-469_eb620096-d9a7-47da-8b98-3568e35a3169 75921-469 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate zolpidem tartrate TABLET, FILM COATED ORAL 20081121 ANDA ANDA078616 Life Line Home Care Services, Inc. ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 75921-490_547fccd0-546e-4e62-812d-9585ae02721f 75921-490 HUMAN PRESCRIPTION DRUG SERTRALINE HYDROCHLORIDE sertraline hydrochloride TABLET, FILM COATED ORAL 19920211 NDA NDA019839 Life Line Home Care Services SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 75921-513_9ab6e359-74b7-4fb3-ac1c-4d59de089604 75921-513 HUMAN PRESCRIPTION DRUG CARISOPRODOL CARISOPRODOL TABLET ORAL 19871101 ANDA ANDA087499 Life Line Home Care Services, Inc CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] CIV E 20171231 75921-515_dc47be05-6e52-4233-90c4-a987cfcaaf8a 75921-515 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20100812 ANDA ANDA077321 Life Line Home Care Services, Inc. LISINOPRIL 20 mg/1 E 20171231 75921-578_71f91916-f638-4af0-8c6d-d0fc0a79b83f 75921-578 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20070125 ANDA ANDA078060 Life Line Home Care Services, Inc. SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 75921-627_d8c3b83b-3f99-41ed-83b4-3d20b19612dd 75921-627 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride TABLET ORAL 20110101 ANDA ANDA076003 Life Line Home Care Services, Inc. TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 75921-648_79f46038-1a1b-4150-8c2f-c0aa160c9846 75921-648 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20120116 ANDA ANDA076001 Life Line Home Care Services, Inc. FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 75921-795_1e266e28-ad46-45dd-9b2a-91d1edcd8b52 75921-795 HUMAN PRESCRIPTION DRUG Dicyclomine Hydrochloride Dicyclomine Hydrochloride TABLET ORAL 20120207 ANDA ANDA085223 Life Line Home Care Services, Inc. DICYCLOMINE HYDROCHLORIDE 20 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] E 20171231 75921-881_b653e3b2-984b-49d7-ae0f-7f120f5d9831 75921-881 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate And Acetaminophen Hydrocodone Bitartrate And Acetaminophen TABLET ORAL 19881202 ANDA ANDA089971 Life Line Home Care Services, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 75921-901_7529098f-5707-46ac-b7cd-bc9c24a728d0 75921-901 HUMAN PRESCRIPTION DRUG ALPRAZOLAM Alprazolam TABLET ORAL 20120126 ANDA ANDA074174 Life Line Home Care Services, Inc. ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 75921-962_56e7edc4-198d-4556-b1e3-28bef7b587cc 75921-962 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET ORAL 20111208 ANDA ANDA065136 Life Line Home Care Services, Inc. CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 75928-001_a5207872-6e00-42dc-8068-cfc8a2d91e4d 75928-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS Nor-Lea Hospital District dba Nor-Lea Home Medical OXYGEN 99 L/100L E 20171231 75930-001_0f530898-6355-44d0-a05a-a54a247e20cf 75930-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS S & G Home Care dba R & M Transfill OXYGEN 99 L/100L E 20171231 75932-1001_0ef868bb-d1b3-4e47-b33a-5844616e4150 75932-1001 HUMAN OTC DRUG MORISU HYALURONIC ACID SOLUTION TOPICAL 20110208 UNAPPROVED DRUG OTHER KIT Living Science of Kyungnam College University of Information & Technology HYALURONIC ACID .01 mL/100mL E 20171231 75932-1002_55fa2e5b-2db6-4549-8d90-33e116e697e2 75932-1002 HUMAN OTC DRUG MORISU HYALURONIC ACID SOLUTION TOPICAL 20110208 UNAPPROVED DRUG OTHER Kyungnam College of Information & Technology HYALURONIC ACID .01 g/100mL E 20171231 75933-1425_506650c0-1839-11e0-8305-0002a5d5c51b 75933-1425 HUMAN OTC DRUG Yuma OATMEAL SOAP TOPICAL 20110601 OTC MONOGRAPH FINAL part347 Yuma Outdoors LLC OATMEAL 1.205 g/1 E 20171231 75936-105_344ebfe9-7ead-48ac-8fbc-ec8c2ad6e98c 75936-105 HUMAN OTC DRUG Invincible Setting powder SPF 45 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20170113 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. TITANIUM DIOXIDE; ZINC OXIDE 15.7; 20 g/100g; g/100g N 20181231 75936-111_fab6558c-994f-48cb-8ddb-ab771efce435 75936-111 HUMAN OTC DRUG City Sunscreen serum Broad Spectrum SPF 30 Supergoop Homosalate, Octisalate, Avobenzene, Octocrylene CREAM TOPICAL 20101207 OTC MONOGRAPH FINAL part352 Taylor James, Ltd. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 8; 4; 3; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 75936-113_32786020-21f1-4551-a282-26c8e1857eb8 75936-113 HUMAN OTC DRUG Mint Fusion Lip Balm SPF 30 Supergoop Octinoxate, Octisalate, Avobenzone CREAM TOPICAL 20120831 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. OCTINOXATE; OCTISALATE; AVOBENZONE 1.11; .74; .44 g/15mL; g/15mL; g/15mL N 20181231 75936-118_1209f08a-9fea-412e-a89c-fc56eff01697 75936-118 HUMAN OTC DRUG Acaifusion Lip Balm Broad Spectrum SPF 30 Supergoop Avobenzone, Octinoxate, Octisalate OINTMENT TOPICAL 20120628 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; OCTINOXATE; OCTISALATE .44; 1.11; .74 g/15mL; g/15mL; g/15mL N 20181231 75936-120_8c562fdb-a0d6-4a94-a5a0-e227a3ab8e01 75936-120 HUMAN OTC DRUG Advanced Anti-Aging Eye Broad Spectrum SPF 37 Supergoop Octinoxate, Zinc Oxide CREAM TOPICAL 20130102 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. OCTINOXATE; ZINC OXIDE 75; 10.1 mg/mL; mg/mL N 20181231 75936-121_15646286-9615-48a2-b1a7-17e8e94c2daf 75936-121 HUMAN OTC DRUG CC Daily Correct Broad Spectrum SPF 35 Sunscreen Light to Medium Supergoop Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20130104 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. TITANIUM DIOXIDE; ZINC OXIDE 20; 200 mg/mL; mg/mL N 20181231 75936-122_d79ad87b-8bdb-4928-8546-b74193ab5adb 75936-122 HUMAN OTC DRUG CC Daily Correct Broad Spectrum SPF 35 Sunscreen Medium to Dark Supergoop Titanium DIoxide, Zinc Oxide CREAM TOPICAL 20130107 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. TITANIUM DIOXIDE; ZINC OXIDE 1.42; 20 g/100mL; g/100mL N 20181231 75936-123_2d005d28-c408-48c8-8980-e1e8e3c43429 75936-123 HUMAN OTC DRUG Sunscreen Mist Broad Spectrum SPF 30 Supergoop Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene SPRAY TOPICAL 20130107 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 10; 7.5; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 75936-124_a1d1b909-1192-416c-8a39-9ccf113612bd 75936-124 HUMAN OTC DRUG Sunscreen Mist Broad Spectrum SPF 50 Supergoop Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene SPRAY TOPICAL 20130129 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 10; 7.5; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 75936-125_7e06dedc-653e-451d-827e-19493e1a6967 75936-125 HUMAN OTC DRUG Sun-Defying Sunscreen Oil Broad Spectrum SPF 50 Supergoop Avobenzone, Homosalate, Octisalate, Octocrylene, Octinoxate OIL TOPICAL 20131203 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OCTINOXATE 3; 15; 5; 7; 7.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 75936-126_d8e23324-7c67-44f3-81c5-e560a7c75d89 75936-126 HUMAN OTC DRUG CC Cream Daily Correct Broad Spectrum SPF 40 Sunscreen Fair to Light Supergooop Titanium Dioxide, Zinc Oxide CREAM TOPICAL 20131204 OTC MONOGRAPH FINAL part352 Taylor James LTD TITANIUM DIOXIDE; ZINC OXIDE 2; 20 g/100mL; g/100mL N 20181231 75936-128_f9b39624-9f7e-4df1-bdc9-139d8c7c8969 75936-128 HUMAN OTC DRUG Forever Young Hand Broad Spectrum SPF 40 Supergoop Avobenzone, Homosalate, Octinoxate, Octocrylene CREAM TOPICAL 20140120 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE 3; 10; 7; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 75936-129_7f752c54-37f3-44eb-9e48-0fa2fa8b57c0 75936-129 HUMAN OTC DRUG Skin Soothing Mineral Sunscreen Broad Spectrum SPF 40 Supergoop Octinoxate, Zinc Oxide CREAM TOPICAL 20140122 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. OCTINOXATE; ZINC OXIDE 7.5; 10.1 g/100mL; g/100mL N 20181231 75936-132_22601586-eb56-406d-9ec7-276d832edf5a 75936-132 HUMAN OTC DRUG Soft Focus City Suncreen Serum Broad Spectrum SPF 30 Supergoop Avobenzone, Homosalate, Octisalate, Octocrylene LIQUID TOPICAL 20141230 OTC MONOGRAPH FINAL part352 Taylor James Ltd AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 8; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 75936-133_bb620cdd-d784-4a9b-b282-84c85d39618d 75936-133 HUMAN OTC DRUG Defense Refresh Settingh Mist Broad Spectrum Sunscreen SPF 50 Supergoop avobenzone, homosalate, Octinoxate, Octisalate LIQUID TOPICAL 20150109 OTC MONOGRAPH FINAL part352 Taylor James, LTD AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 3; 4; 6; 3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 75936-135_3bb571a8-4e7c-4431-ab8e-f797560be9f6 75936-135 HUMAN OTC DRUG Everyday Sunscreen SPF 50 Supergoop Avobenzone, Homosalate, Octinoxate, Octisalate LOTION TOPICAL 20150120 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 3; 10; 7.5; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 75936-139_c2089f1e-8ada-4ef1-8057-3f1b3e9f9afc 75936-139 HUMAN OTC DRUG Forever Young Body Butter Broad Spectrum Sunscreen SPF 40 Supergoop Avobenzone, Homosalate, Octinoxate, Octisalate CREAM TOPICAL 20150513 OTC MONOGRAPH FINAL part352 Taylor James Ltd AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 3; 7.5; 7.5; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 75936-141_0be442f4-34a8-4ab8-859d-059896c1d63d 75936-141 HUMAN OTC DRUG Shine On Lip Sunscreen Broad Spectrum SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate CREAM TOPICAL 20160105 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 3; 10; 7.5; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 75936-142_a6c5aa7a-b7ae-43d5-833b-b2fbc4450e15 75936-142 HUMAN OTC DRUG Unseen Sunscreen Broad Spectrum SPF 40 Avobenzone, Homosalate, Octinoxate, Octisalate CREAM TOPICAL 20171010 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 3; 8; 4.5; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 75936-143_61cfff7c-b501-fa11-e053-2991aa0ac15c 75936-143 HUMAN OTC DRUG Healthy Glow Sunless Tan Broad Spectrum SPF 40 Avobenzone, Homosalate, Octinoxate, Octisalate LOTION TOPICAL 20180102 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 2; 10; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL N 20191231 75936-144_638a9cc0-1073-aef5-e053-2991aa0a5da0 75936-144 HUMAN OTC DRUG Glow Stick Broad spectrum SPF 50 Avobenzone, Homosalate, Octinoxate, Octisalate STICK TOPICAL 20180103 OTC MONOGRAPH FINAL part352 Taylor James Ltd. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTINOXATE 10; 5; 3; 7.5 g/100g; g/100g; g/100g; g/100g N 20191231 75936-145_faf63abc-ef54-400e-8c94-0fdf29d75b9e 75936-145 HUMAN OTC DRUG Invincible Setting Powder SPF 45 Translucent Zinc Oxide POWDER TOPICAL 20180115 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. ZINC OXIDE 24.5 g/100g N 20191231 75936-146_3e05f511-490b-4972-a705-c3184b438ebc 75936-146 HUMAN OTC DRUG Invincible Setting Powder SPF 45 Light Zinc Oxide POWDER TOPICAL 20180115 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. ZINC OXIDE 24.5 g/100g N 20191231 75936-147_d791fe57-f850-4032-8e2d-0b5178eb7f52 75936-147 HUMAN OTC DRUG Invincible Setting Powder SPF 45 medium Zinc Oxide POWDER TOPICAL 20180115 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. ZINC OXIDE 24.5 g/100g N 20191231 75936-148_59b762a8-c265-4819-9803-6c1a4abb52a3 75936-148 HUMAN OTC DRUG Invincible Setting Powder SPF 45 Deep Zinc Oxide POWDER TOPICAL 20180115 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. ZINC OXIDE 24.5 g/100g N 20191231 75936-201_38b65965-8490-4899-bc40-22f5c2a64dc8 75936-201 HUMAN OTC DRUG Mint Condition Lip Shield SPF 30 Supergoop Avobenzone, Octisalate, Homosalate, Octinoxate STICK TOPICAL 20160808 OTC MONOGRAPH FINAL part352 T AYLO R JAMES, LT D. AVOBENZONE; OCTISALATE; HOMOSALATE; OCTINOXATE 2; 5; 15; 7.5 g/100g; g/100g; g/100g; g/100g N 20181231 75936-221_327a49ba-eeaf-482d-b946-b644d7e0d9a3 75936-221 HUMAN OTC DRUG City Sunscreen serum Broad Spectrum SPF 30 Supergoop Homosalate, Octisalate, Avobenzene, Octocrylene CREAM TOPICAL 20101207 OTC MONOGRAPH FINAL part352 Taylor James, Ltd. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 8; 4; 3; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 75936-222_e2fa1307-db7c-4248-b660-d61be7f90181 75936-222 HUMAN OTC DRUG City Sunscreen serum Broad Spectrum SPF 30 Supergoop Homosalate, Octisalate, Avobenzene, Octocrylene CREAM TOPICAL 20101207 OTC MONOGRAPH FINAL part352 Taylor James, Ltd. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 8; 4; 3; 2 g/100kg; g/100kg; g/100kg; g/100kg N 20181231 75936-500_831a8743-e6f8-443f-98d9-9f559e6dfd1e 75936-500 HUMAN OTC DRUG Perfect Day 2 in 1 Everywear SPF 50 and Mint Condition Lip Shield SPF 30 Supergoop Avobenzone, Homosalate, Octinoxate, Octisalate KIT 20160916 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. N 20181231 75936-503_a1115586-fb37-4c57-bddc-606dbf58a41c 75936-503 HUMAN OTC DRUG Lip and Cheek Treat Broad Spectrum SPF 40 Supergoop Avobenzone, Homosalate, Octinoxate, Octisalate STICK TOPICAL 20161104 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 3; 10; 7.5; 5 g/100g; g/100g; g/100g; g/100g N 20181231 75936-504_5b9aaca3-5615-4398-8221-9f764b2dbe28 75936-504 HUMAN OTC DRUG Super Power Sunscreen Mousse SPF 50 Supergoop Avobenzone, Homosalate, Octinoxate, Octisalate CREAM TOPICAL 20170113 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 3; 10; 7.5; 5 kg/100kg; kg/100kg; kg/100kg; kg/100kg N 20181231 75936-505_884751ea-4fcb-4e86-87b4-599aac0efb38 75936-505 HUMAN OTC DRUG Super Power Sunscreen Mousse SPF 50 Supergoop Avobenzone, Homosalate, Octinoxate, Octisalate CREAM TOPICAL 20170113 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 3; 10; 7.5; 5 kg/100mL; kg/100mL; kg/100mL; kg/100mL N 20181231 75936-510_8277b4ce-492b-431e-96ed-b24b6ac6ee19 75936-510 HUMAN OTC DRUG Mineral Sunscreen SPF 30 Zinc Oxide SPRAY TOPICAL 20170515 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. ZINC OXIDE 12 g/100mL N 20181231 75936-511_6bfc2110-0ef5-49ef-8396-6f33b4ec609f 75936-511 HUMAN OTC DRUG Mineral Sunscreen Stick SPF 50 Supergoop Zinc Oxide STICK TOPICAL 20170814 OTC MONOGRAPH FINAL part352 TAYLOR JAMES, LTD. ZINC OXIDE 17 g/100g N 20181231 75939-9876_410a54c1-cdb4-465b-83f6-9986185f2ff1 75939-9876 HUMAN OTC DRUG Liqufruta GUAIFENESIN SYRUP ORAL 20110101 OTC MONOGRAPH FINAL part341 Alston Garrard & Co GUAIFENESIN 50 mg/5mL E 20171231 75939-9876_ffde5fe1-c84d-4ccf-a417-36ff56b47790 75939-9876 HUMAN OTC DRUG Liqufruta GUAIFENESIN SYRUP ORAL 20110101 OTC MONOGRAPH FINAL part341 Alston Garrard & Co GUAIFENESIN 50 mg/5mL E 20171231 75940-111_a48d0d1f-9cd4-4170-91ea-c2270ce26e07 75940-111 HUMAN OTC DRUG Pasta de Lassar Andromaco Zinc Oxide CREAM TOPICAL 20140701 OTC MONOGRAPH FINAL part347 MarcasUSA LLC ZINC OXIDE 250 mg/g N 20181231 75940-121_daf1a114-98d1-4a1a-92de-7a6db9057ca7 75940-121 HUMAN OTC DRUG Conazol Miconazole Nitrate CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part333C MarcasUSA LLC MICONAZOLE NITRATE 20 mg/g N 20181231 75940-122_529386ad-ddbe-4eb3-a253-00d87f89b8d8 75940-122 HUMAN OTC DRUG CICLOFERON benzalkonium chloride and lidocaine hydrochloride GEL TOPICAL 20110801 OTC MONOGRAPH NOT FINAL part333A MarcasUSA LLC BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE 1.3; 20 mg/g; mg/g N 20181231 75940-126_3503ec7b-485e-4d1f-ac98-7c3fa98dba79 75940-126 HUMAN OTC DRUG Conazol antifungal Tolnaftate SOLUTION/ DROPS TOPICAL 20171029 OTC MONOGRAPH FINAL part333C MarcusUSA TOLNAFTATE 10 mg/mL N 20181231 75940-127_54c2ead1-8b2d-4024-ab16-ae6bd2644994 75940-127 HUMAN OTC DRUG Conazol Miconazole Nitrate SPRAY TOPICAL 20140625 OTC MONOGRAPH FINAL part333C MarcasUSA LLC MICONAZOLE NITRATE 20 mg/g N 20181231 75940-141_91f6e47e-186e-454d-8d55-62edafb1b9bc 75940-141 HUMAN OTC DRUG Syncol Acetaminophen, Pamabrom, Pyrilamine Maleate CAPSULE ORAL 20150701 OTC MONOGRAPH NOT FINAL part343 MarcasUSA LLC ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE 500; 25; 15 mg/1; mg/1; mg/1 N 20181231 75940-171_6c7c7bed-7527-44ce-9616-f155db2e4753 75940-171 HUMAN OTC DRUG Herklin Piperonyl butoxide and Pyrethrum extract SHAMPOO TOPICAL 20171029 OTC MONOGRAPH FINAL part358G MarcusUSA PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 40; .033 mg/mL; mg/mL N 20181231 75942-001_c0e15e03-c564-428a-b6c9-46d114062fd2 75942-001 HUMAN OTC DRUG Adult Low Dose Aspirin Enteric Safety Coated Aspirin TABLET, DELAYED RELEASE ORAL 20110118 OTC MONOGRAPH FINAL part343 Zandi LLC ASPIRIN 81 mg/1 N 20181231 75944-100_b1e56151-1121-47fa-9dfa-d59fbb0a6f5f 75944-100 HUMAN OTC DRUG SOL LEON Sunscreen SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20101215 OTC MONOGRAPH FINAL part352 Bottega di Lungavita Srl AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE 3; 8; 5; 8 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 75944-200_4c218401-e440-4a07-80da-5fbb6041a552 75944-200 HUMAN OTC DRUG SOL LEON Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OCTINOXATE CREAM TOPICAL 20101215 OTC MONOGRAPH FINAL part352 Bottega di Lungavita Srl AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OCTINOXATE 3; 8; 5; 8; 7.5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 75956-145_5023056c-49c6-4e78-819e-1d861d8b8302 75956-145 HUMAN OTC DRUG Male Desensitizer Pleasure Balm Benzocaine GEL TOPICAL 20110214 OTC MONOGRAPH FINAL part348 Kama Sutra BENZOCAINE 3 g/100mL E 20171231 75956-147_a06013fd-3e81-4672-b660-34c16255ca07 75956-147 HUMAN OTC DRUG Pleasure Balm Kama Sutra Benzocaine GEL TOPICAL 20130912 OTC MONOGRAPH FINAL part348 Kama Sutra BENZOCAINE 5 g/100mL E 20171231 75957-001_8c456365-71e6-47eb-85e1-f4c7bd793fbc 75957-001 HUMAN OTC DRUG Pampers Kandoo Benzalkonium Chloride SOLUTION CUTANEOUS 20110214 OTC MONOGRAPH NOT FINAL part333E Nehemiah Manufacturing BENZALKONIUM CHLORIDE 1.3 mg/mL E 20171231 75957-002_8c456365-71e6-47eb-85e1-f4c7bd793fbc 75957-002 HUMAN OTC DRUG Pampers Kandoo Benzalkonium Chloride SOLUTION CUTANEOUS 20110214 OTC MONOGRAPH NOT FINAL part333E Nehemiah Manufacturing BENZALKONIUM CHLORIDE 2.6 mg/2mL E 20171231 75958-1001_97670bb0-6eb8-4079-805c-41f093237c04 75958-1001 HUMAN OTC DRUG Insan Bamboosalt toothpaste CALCIUM CARBONATE PASTE, DENTIFRICE DENTAL 20110213 UNAPPROVED DRUG OTHER Insan Bamboo Salt Inc CALCIUM CARBONATE 31.25 g/100g E 20171231 75963-125_f413f3df-ff3e-4640-8f84-d13f951ab746 75963-125 HUMAN OTC DRUG Reactice Reactivating Ice Baume Menthol CREAM TOPICAL 20110721 OTC MONOGRAPH NOT FINAL part348 Rejuventus, Inc. MENTHOL 118.29 mL/100mL E 20171231 75963-126_e164cea7-2085-4617-a595-f90032c53ce3 75963-126 HUMAN OTC DRUG Reactheat Heat Baume Menthol, Capsicum Annum Extract CREAM TOPICAL 20110820 OTC MONOGRAPH FINAL part348 Rejuventus MENTHOL; BIRD PEPPER 5; .5 mL/100mL; mL/100mL E 20171231 75974-100_64fa5e20-6161-4ce5-9ef8-70b10f6939cc 75974-100 HUMAN OTC DRUG ANC Neverpain External Analgesic MENTHOL SPRAY TOPICAL 20110324 OTC MONOGRAPH NOT FINAL part348 ANC Amazon Natural Corp. MENTHOL 5 mL/100mL E 20171231 75974-200_d9734964-d70e-46b8-a88b-b046c730bac4 75974-200 HUMAN OTC DRUG Neverpain MENTHOL SPRAY TOPICAL 20160811 OTC MONOGRAPH NOT FINAL part348 ANC Amazon Natural Corp. MENTHOL, UNSPECIFIED FORM 5 g/100mL N 20181231 75978-3048_98fd25cc-3f88-4cb7-9b6a-819058a64e56 75978-3048 HUMAN OTC DRUG Thai Herbal Balm Lemon Grass Menthol and Camphor (synthetic) OINTMENT TOPICAL 20070109 OTC MONOGRAPH NOT FINAL part348 Thai Herb and Spa MENTHOL; METHYL SALICYLATE 5; 6 g/50g; g/50g E 20171231 75978-3049_a3d2b62f-d104-4e93-8711-d84cc5a5aade 75978-3049 HUMAN OTC DRUG Thai Herbal Balm Lavender Menthol and Camphor (synthetic) OINTMENT TOPICAL 20070109 OTC MONOGRAPH NOT FINAL part348 Thai Herb and Spa MENTHOL; CAMPHOR (SYNTHETIC) 2.5; 1.5 g/50g; g/50g E 20171231 75979-1146_31577dd2-d7ed-4239-a76c-52f1a5190c4c 75979-1146 HUMAN OTC DRUG Imbue Pain Relief menthol - methyl salicylate PATCH TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part356 Imbue Body LLC MENTHOL; METHYL SALICYLATE 51; 15 mg/1; mg/1 E 20171231 75979-1146_a8afe16c-2d30-4ace-a701-78f7a1856fa8 75979-1146 HUMAN OTC DRUG Imbue Pain Relief menthol - methyl salicylate PATCH TOPICAL 20110601 OTC MONOGRAPH NOT FINAL part356 Imbue Body LLC MENTHOL; METHYL SALICYLATE 51; 15 mg/1; mg/1 E 20171231 75981-002_5ae36394-b849-0c3d-e053-2a91aa0a2f02 75981-002 HUMAN OTC DRUG Menthol Cough Drops Menthol LOZENGE ORAL 20130315 OTC MONOGRAPH FINAL part341 Geiss, Destin & Dunn MENTHOL 5.4 mg/1 N 20181231 75981-003_5ae36394-b85b-0c3d-e053-2a91aa0a2f02 75981-003 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20160323 OTC MONOGRAPH FINAL part341 Geiss, Destin & Dunn MENTHOL 5.8 mg/1 N 20181231 75981-003_5ae3a701-3e05-388f-e053-2991aa0a7a60 75981-003 HUMAN OTC DRUG Cherry Cough Drops Menthol LOZENGE ORAL 20130315 OTC MONOGRAPH FINAL part341 Geiss, Destin & Dunn MENTHOL 5.8 mg/1 N 20181231 75981-004_be5e0db6-8ef6-43c8-9416-0af055f0c8ac 75981-004 HUMAN OTC DRUG GOODSENSE ANTIBACTERIAL MOISTURIZING BENZALKONIUM CHLORIDE FILM TOPICAL 20110221 OTC MONOGRAPH NOT FINAL part333A GEISS, DESTIN AND DUNN, INC. BENZALKONIUM CHLORIDE .115 g/1001 N 20181231 75981-005_41fdbe93-33ee-3120-e054-00144ff88e88 75981-005 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20160329 OTC MONOGRAPH FINAL part341 Geiss, Destin & Dunn MENTHOL 7.5 mg/1 N 20181231 75981-005_5ae398c9-10ec-8aa2-e053-2a91aa0a17eb 75981-005 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20130315 OTC MONOGRAPH FINAL part341 Geiss, Destin & Dunn MENTHOL 7.5 mg/1 N 20181231 75981-005_5ae41965-eca4-0fb4-e053-2991aa0a34f2 75981-005 HUMAN OTC DRUG Honey Lemon Cough Drops Menthol LOZENGE ORAL 20160323 OTC MONOGRAPH FINAL part341 Geiss, Destin & Dunn MENTHOL 7.5 mg/1 N 20181231 75981-006_5ae542e5-e0a6-1441-e053-2991aa0ad185 75981-006 HUMAN OTC DRUG sugar free cherry cough drops menthol LOZENGE ORAL 20120627 OTC MONOGRAPH FINAL part341 Geiss, Destin & Dunn MENTHOL 5.8 mg/1 N 20181231 75981-007_2cf927a5-aed6-4316-ae4c-71d810f4c6bc 75981-007 HUMAN OTC DRUG GOODSENSE MEDICATED PADS WITCH HAZEL SOLUTION RECTAL; TOPICAL 20110601 OTC MONOGRAPH FINAL part346 GEISS, DESTIN AND DUNN, INC. WITCH HAZEL .5 mL/mL N 20181231 75981-008_42613a34-1b2a-4172-e054-00144ff8d46c 75981-008 HUMAN OTC DRUG cherry sore throat lozenze benzocaine LOZENGE ORAL 20160329 OTC MONOGRAPH NOT FINAL part356 Geiss, Destin & Dunn BENZOCAINE; MENTHOL 15; 3.6 mg/1; mg/1 N 20181231 75981-009_4263eb91-3e30-36a9-e054-00144ff88e88 75981-009 HUMAN OTC DRUG mixed berry sore throat and cough lozenge benzocaine LOZENGE ORAL 20160329 OTC MONOGRAPH NOT FINAL part356 Geiss, Destin & Dunn BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE 7.5; 5 mg/1; mg/1 N 20181231 75981-010_44b9f997-87d8-1f0a-e054-00144ff88e88 75981-010 HUMAN OTC DRUG Cherry antacid soft chews calcium carbonate TABLET, CHEWABLE ORAL 20120604 OTC MONOGRAPH FINAL part331 Geiss, Destin, & Dunn CALCIUM CARBONATE 1177 mg/1 N 20181231 75981-063_5f09a3f8-b471-4562-9510-95b6ecd6faab 75981-063 HUMAN OTC DRUG Calamine FERRIC OXIDE RED LOTION TOPICAL 19920915 OTC MONOGRAPH FINAL part347 Geiss, Destin and Dunn, Inc FERRIC OXIDE RED; ZINC OXIDE 8; 8 g/mL; mg/mL N 20181231 75981-069_cde875fa-21cc-4b19-88d5-83d0e6e3ca30 75981-069 HUMAN OTC DRUG Petroleum White Petrolatum JELLY TOPICAL 19920615 OTC MONOGRAPH FINAL part347 Geiss, Destin and Dunn, Inc PETROLATUM 1 g/g N 20181231 75981-124_ecfe8535-bb84-4407-bfb6-fccf7325b649 75981-124 HUMAN OTC DRUG Goodsense Extra Strength Cold and Hot Medicated Menthol PATCH TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part348 Geiss, Destin and Dunn, Inc. MENTHOL 750 mg/1 N 20181231 75981-153_ebfb59d3-5808-4b68-b2ad-fa798ad034b9 75981-153 HUMAN OTC DRUG Everyday Clean Dandruff Pyrithione zinc SHAMPOO TOPICAL 20090518 OTC MONOGRAPH FINAL part358H Geiss, Destin + Dunn, Inc PYRITHIONE ZINC 1 g/100mL N 20181231 75981-210_e5a7d306-dcea-45ae-984a-ce6342917de0 75981-210 HUMAN OTC DRUG Antiseptic Mouth Rinse EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL MOUTHWASH ORAL 19930709 OTC MONOGRAPH NOT FINAL part348 Geiss, Destin + Dunn EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 75981-213_35497993-615b-4e57-87a8-da03214720ec 75981-213 HUMAN OTC DRUG Anticavity Fluoride Rinse SODIUM FLUORIDE MOUTHWASH ORAL 20070817 OTC MONOGRAPH FINAL part355 Geiss, Destin + Dunn, Inc SODIUM FLUORIDE .05 kg/100L N 20181231 75981-226_657a4902-7aa7-47b9-b1a1-34143e078518 75981-226 HUMAN OTC DRUG Creamy Diaper Rash Zinc Oxide OINTMENT TOPICAL 19931027 OTC MONOGRAPH FINAL part347 Geiss, Destin + Dunn, Inc ZINC OXIDE 13 kg/100kg N 20181231 75981-299_3780f82a-1779-4852-93e3-427719802972 75981-299 HUMAN OTC DRUG Antiseptic CETYLPYRIDINIUM CHLORIDE RINSE ORAL 19930920 OTC MONOGRAPH NOT FINAL part356 Geiss, Destin and Dunn, Inc CETYLPYRIDINIUM CHLORIDE .7 mg/mL N 20181231 75981-318_06eff263-2357-4626-a29b-6ae5b42cc3bf 75981-318 HUMAN OTC DRUG Antiseptic Eucayptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19900915 OTC MONOGRAPH NOT FINAL part356 Geiss, Destin + Dunmn, Inc EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .092; .042; .06; .064 kg/100L; kg/100L; kg/100L; kg/100L N 20181231 75981-370_160c1bec-33a8-4c3e-bd30-963f1d94d9c5 75981-370 HUMAN OTC DRUG Advanced Ethyl Alcohol GEL TOPICAL 20120920 OTC MONOGRAPH NOT FINAL part333A Geiss, Destin + Dunn, Inc ALCOHOL 70 kg/100L N 20181231 75981-602_d8affacb-70ca-4970-ac69-18e0f51d0d7c 75981-602 HUMAN OTC DRUG Epsom Salt Magnesium Sulfate GRANULE, FOR SOLUTION ORAL; TOPICAL 19920715 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin and Dunn, Inc MAGNESIUM SULFATE HEPTAHYDRATE 1 g/g N 20181231 75981-664_5df1eb70-56ac-4cf8-a9f8-94dd4b52739f 75981-664 HUMAN OTC DRUG Antispetic Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH ORAL 19921001 OTC MONOGRAPH NOT FINAL part356 Geiss, Destin + Dunn, Inc. EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL .92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 75981-667_372bc4ef-9189-443a-ae33-35f6e935481d 75981-667 HUMAN OTC DRUG Citroma Magnesium Citrate LIQUID ORAL 20090518 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 75981-686_c71b1bc6-168f-4608-9143-0325ca73224c 75981-686 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20090518 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 75981-693_6d1c9200-a777-489a-8700-b28534445827 75981-693 HUMAN OTC DRUG citroma Magesium Citrate LIQUID ORAL 20090518 OTC MONOGRAPH NOT FINAL part334 Geiss, Destin & Dunn, Inc. MAGNESIUM CITRATE 1.745 g/29.61mL N 20181231 75981-909_6d0a35f3-4f5c-486f-bbc3-ad6244ceb120 75981-909 HUMAN OTC DRUG Beauty Hydrating Octinoxate, Zinc Oxide LOTION TOPICAL 20061108 OTC MONOGRAPH NOT FINAL part352 Geiss, Destin + Dunn, Inc OCTINOXATE; ZINC OXIDE 61.2; 30.6 mg/mL; mg/mL N 20181231 75983-000_6c666de2-51d4-4a4f-bbc6-cfcda0e83c0e 75983-000 HUMAN OTC DRUG First Aid Antibiotic Bacitraycin Plus Bacitracin CREAM TOPICAL 20130630 OTC MONOGRAPH FINAL part333B First Aid Research Corp. BACITRACIN 500 [USP'U]/g N 20181231 75983-001_4880a518-798f-0960-e054-00144ff8d46c 75983-001 HUMAN OTC DRUG First Aid Antibiotic Bacitracin with Zinc Bacitracin Zinc OINTMENT TOPICAL 20170214 OTC MONOGRAPH FINAL part333B First Aid Research Corp. BACITRACIN ZINC 500 [USP'U]/g N 20181231 75983-002_61cd7804-a685-4a1f-e053-2991aa0a7c94 75983-002 HUMAN OTC DRUG First Aid Antifungal Medicated Tolnaftate CREAM TOPICAL 20180102 OTC MONOGRAPH FINAL part333C First Aid Research Corp. TOLNAFTATE 10 mg/g N 20191231 75983-003_52d94a83-9987-4724-a839-076ef6a9b5a3 75983-003 HUMAN OTC DRUG First Aid Original Bacitraycin Plus Bacitraycin OINTMENT TOPICAL 20140305 OTC MONOGRAPH FINAL part333B First Aid Research Corp. BACITRACIN 500 [USP'U]/g N 20181231 75983-420_bee322c0-c967-4080-8a21-c72afde0cd85 75983-420 HUMAN OTC DRUG First Aid Research Antifungal .5oz Clotrimazole CREAM TOPICAL 20141014 OTC MONOGRAPH FINAL part333C First Aid Research Corp. CLOTRIMAZOLE 10 mg/g N 20181231 75983-424_4f0b7c51-26f9-4bcc-a83f-228915effe04 75983-424 HUMAN OTC DRUG Natural Epsom Salts Magnesium Sulfate CRYSTAL ORAL; TOPICAL 20150515 OTC MONOGRAPH NOT FINAL part334 FIRST AID RESEARCH CORP. MAGNESIUM SULFATE 100 g/100g N 20181231 75983-464_fca0c59d-8a8f-405b-80ab-d70a31ad7fab 75983-464 HUMAN OTC DRUG First Aid Research Antifungal Cream 1oz Clotrimazole CREAM TOPICAL 20141014 OTC MONOGRAPH FINAL part333C First Aid Research Corp. CLOTRIMAZOLE 10 mg/g N 20181231 75983-495_76fbb85c-7155-4b52-858e-4e29e1922ff6 75983-495 HUMAN OTC DRUG First Aid Macimum Sterngth Bacitraycin Plus Bacitracin OINTMENT TOPICAL 20130630 OTC MONOGRAPH FINAL part333B First Aid Research Corp BACITRACIN; LIDOCAINE 500; 40 [USP'U]/g; mg/g N 20181231 75983-515_1b89ee06-bee4-4eff-a7ce-19895a877bb6 75983-515 HUMAN OTC DRUG First Aid Antifungal Medicated Cream 0.5 oz Tolnaftate CREAM TOPICAL 20141009 OTC MONOGRAPH FINAL part333C First Aid Reserach Corp TOLNAFTATE 10 mg/g N 20181231 75983-537_c7319ee5-9106-4f5c-b9e0-1d5cb5e0cc7b 75983-537 HUMAN OTC DRUG First Aid Antifungal Medicated Cream 1oz Tolnaftate CREAM TOPICAL 20141009 OTC MONOGRAPH FINAL part333C First Aid Reserach Corp TOLNAFTATE 10 mg/g N 20181231 75983-555_338e6827-3cab-4049-b312-78e7857cdeaa 75983-555 HUMAN OTC DRUG First Aid Research Bacitraycin Plus Maximum Vertical Bacitracin Lidocaine OINTMENT TOPICAL 20140306 OTC MONOGRAPH FINAL part333B First Aid Research Corp. BACITRACIN; LIDOCAINE 500; 40 [USP'U]/g; mg/g N 20181231 75983-738_b55dceb1-8133-4df6-b070-4810666a951f 75983-738 HUMAN OTC DRUG FIRST AID RESEARCH CHAFE AWAY MEDICATED HEALING MENTHOL AND ZINC OXIDE OINTMENT TOPICAL 20130101 OTC MONOGRAPH FINAL part347 FIRST AID RESEARCH CORP. MENTHOL; ZINC OXIDE .44; 20 g/100g; g/100g E 20171231 75984-001_e5506944-d50a-4086-8976-f6e608b87cf8 75984-001 HUMAN OTC DRUG NEW DOCTOR AG PLUS GOLD SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20100901 OTC MONOGRAPH FINAL part355 HANIL PHARMACEUTICAL CO., LTD. SODIUM MONOFLUOROPHOSPHATE .15 g/150g E 20171231 75987-010_74cc39f2-dea6-4f02-a0d5-8ec59538fcac 75987-010 HUMAN PRESCRIPTION DRUG DUEXIS Ibuprofen and Famotidine TABLET, COATED ORAL 20110429 NDA NDA022519 Horizon Pharma Inc. IBUPROFEN; FAMOTIDINE 800; 26.6 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] N 20181231 75987-020_1279d3aa-706d-4665-8f22-7f88bb090445 75987-020 HUMAN PRESCRIPTION DRUG RAYOS prednisone TABLET, DELAYED RELEASE ORAL 20120727 NDA NDA202020 Horizon Pharma Inc. PREDNISONE 1 mg/1 N 20181231 75987-021_1279d3aa-706d-4665-8f22-7f88bb090445 75987-021 HUMAN PRESCRIPTION DRUG RAYOS prednisone TABLET, DELAYED RELEASE ORAL 20120727 NDA NDA202020 Horizon Pharma Inc. PREDNISONE 2 mg/1 N 20181231 75987-022_1279d3aa-706d-4665-8f22-7f88bb090445 75987-022 HUMAN PRESCRIPTION DRUG RAYOS prednisone TABLET, DELAYED RELEASE ORAL 20120727 NDA NDA202020 Horizon Pharma Inc. PREDNISONE 5 mg/1 N 20181231 75987-030_01d394a4-2c7a-4aee-b741-807334538a30 75987-030 HUMAN PRESCRIPTION DRUG Vimovo Naproxen and Esomeprazole Magnesium TABLET, DELAYED RELEASE ORAL 20140101 NDA NDA022511 Horizon Pharma Inc. NAPROXEN; ESOMEPRAZOLE MAGNESIUM 500; 20 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 75987-031_01d394a4-2c7a-4aee-b741-807334538a30 75987-031 HUMAN PRESCRIPTION DRUG Vimovo Naproxen and Esomeprazole Magnesium TABLET, DELAYED RELEASE ORAL 20140101 NDA NDA022511 Horizon Pharma Inc. NAPROXEN; ESOMEPRAZOLE MAGNESIUM 375; 20 mg/1; mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 75987-040_d1c66e61-4c72-4e33-9561-40e06e2d274a 75987-040 HUMAN PRESCRIPTION DRUG Pennsaid diclofenac sodium SOLUTION TOPICAL 20150101 NDA NDA204623 Horizon Pharma Inc. DICLOFENAC SODIUM 20 mg/g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 75987-050_b11bc3e3-8cc3-4a3e-98ee-30a629af0eb2 75987-050 HUMAN PRESCRIPTION DRUG Ravicti glycerol phenylbutyrate LIQUID ORAL 20130228 NDA NDA203284 Horizon Therapeutics, LLC. GLYCEROL PHENYLBUTYRATE 1.1 g/mL N 20181231 75987-060_8b23789a-d8e5-4bdf-8a01-25b7ecd1d51d 75987-060 HUMAN PRESCRIPTION DRUG BUPHENYL sodium phenylbutyrate TABLET ORAL 19960513 NDA NDA020572 Horizon Pharma, Inc. SODIUM PHENYLBUTYRATE 500 mg/1 Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 75987-070_8b23789a-d8e5-4bdf-8a01-25b7ecd1d51d 75987-070 HUMAN PRESCRIPTION DRUG Buphenyl sodium phenylbutyrate POWDER ORAL 19960430 NDA NDA020573 Horizon Pharma, Inc. SODIUM PHENYLBUTYRATE .94 g/g Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC] N 20181231 75987-080_8c702d58-072e-4a01-8c8b-25b96794272c 75987-080 HUMAN PRESCRIPTION DRUG Krystexxa pegloticase INJECTION, SOLUTION INTRAVENOUS 20100914 BLA BLA125293 Horizon Pharma Inc. PEGLOTICASE 8 mg/mL Urate Oxidase [Chemical/Ingredient],Uric Acid-specific Enzyme [EPC] N 20181231 75987-090_eb79b0e8-07d8-478d-80a8-65bc9476e1b3 75987-090 HUMAN PRESCRIPTION DRUG Migergot ergotamine tartrate and caffeine SUPPOSITORY RECTAL 19831030 ANDA ANDA086557 Horizon Pharma Inc. ERGOTAMINE TARTRATE; CAFFEINE 2; 100 mg/1; mg/1 Ergotamine Derivative [EPC],Ergotamines [Chemical/Ingredient],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient] N 20191231 75987-100_0f915a4e-1963-4c85-91d1-2eb3958d6282 75987-100 HUMAN PRESCRIPTION DRUG PROCYSBI Cysteamine bitartrate CAPSULE, DELAYED RELEASE PELLETS ORAL 20130430 NDA NDA203389 Horizon Pharma Inc. CYSTEAMINE BITARTRATE 25 mg/1 Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] N 20191231 75987-101_0f915a4e-1963-4c85-91d1-2eb3958d6282 75987-101 HUMAN PRESCRIPTION DRUG PROCYSBI Cysteamine bitartrate CAPSULE, DELAYED RELEASE PELLETS ORAL 20130430 NDA NDA203389 Horizon Pharma Inc. CYSTEAMINE BITARTRATE 75 mg/1 Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA] N 20191231 75987-111_e155bd16-4e4b-4dbf-93e3-53f074295fc9 75987-111 HUMAN PRESCRIPTION DRUG ACTIMMUNE Interferon gamma-1b INJECTION, SOLUTION SUBCUTANEOUS 20131201 BLA BLA103836 Horizon Pharma Inc. INTERFERON GAMMA-1B 100 ug/.5mL Interferon gamma [EPC],Interferon-gamma [Chemical/Ingredient] N 20181231 75990-007_87ae6fae-62b6-42f3-9e18-394f2c039677 75990-007 HUMAN OTC DRUG Celox Ultra ALCOHOL LIQUID TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL .7 mL/mL N 20181231 75990-221_35324617-5ece-4d58-ade3-60838136be9e 75990-221 HUMAN OTC DRUG Celox Antiseptic ALCOHOL GEL TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL .7 mL/mL N 20181231 75990-300_25e7f9a9-a63b-4f71-8fa5-547e80d08c8a 75990-300 HUMAN OTC DRUG Purgo Ultra PC CHLOROXYLENOL SOAP TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. CHLOROXYLENOL 6 mg/mL N 20181231 75990-3018_8d98ed62-13c8-4cff-87cc-4420b14faf8a 75990-3018 HUMAN OTC DRUG Certus Alcohol Prep ISOPROPYL ALCOHOL SWAB TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333A Certus Medical, Inc. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 75990-3111_4953d7ab-9b9e-434e-9bdb-c04d0d4a0199 75990-3111 HUMAN OTC DRUG Certus Alcohol Prep ISOPROPYL ALCOHOL SWAB TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333A Certus Medical, Inc. ISOPROPYL ALCOHOL .7 mL/mL N 20181231 75990-365_01d51044-b305-4c8e-817b-4ad616583aa5 75990-365 HUMAN OTC DRUG Recens Ultra ALCOHOL LOTION TOPICAL 20110728 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL .7 mL/mL E 20171231 75990-370_31347013-37bc-4e41-a712-1067de8e1659 75990-370 HUMAN OTC DRUG Securo Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20170314 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 75990-4019_fc50a967-7f03-44c3-80e5-ebd469a9c979 75990-4019 HUMAN OTC DRUG Certus PVP-1 Prep Swabstick POVIDONE-IODINE SWAB TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. POVIDONE-IODINE .1 mL/mL N 20181231 75990-5008_e5e298f9-51c0-42ed-bc49-163b6a8a2c9a 75990-5008 HUMAN OTC DRUG Certus BZK Antiseptic Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333A Certus Medical, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL N 20181231 75990-5018_dbe9775a-2a9d-4317-aa96-92b0c9e61366 75990-5018 HUMAN OTC DRUG Certus Antiseptic Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333A Certus Medical, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL N 20181231 75990-5028_51a62225-1e11-45bd-9b56-8703e4e44253 75990-5028 HUMAN OTC DRUG Certus Wash Towelette BENZALKONIUM CHLORIDE SWAB TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333A Certus Medical, Inc. BENZALKONIUM CHLORIDE .0013 mL/mL N 20181231 75990-572_6da92fda-1e25-4b86-b7fa-b7404602e62f 75990-572 HUMAN OTC DRUG Purgo Ultra TRICLOSAN SOAP TOPICAL 20110429 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. TRICLOSAN 3 mg/mL E 20171231 75990-575_54c76a08-929f-420a-b316-977ab50e76d4 75990-575 HUMAN OTC DRUG Secure BENZETHONIUM CHLORIDE LIQUID TOPICAL 20130301 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 75990-576_66918764-8f63-46db-8d27-0e41cd1c86ea 75990-576 HUMAN OTC DRUG Purgo Ultra Foam TRICLOSAN SOAP TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. TRICLOSAN 3 mg/mL E 20171231 75990-605_c8b5c9ef-0ab3-4bb7-ab31-5294f28adb07 75990-605 HUMAN OTC DRUG Recens ALCOHOL GEL TOPICAL 20110519 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL .7 mL/mL N 20181231 75990-637_336e5e9a-5f3a-49ba-9017-f08fe20de8e1 75990-637 HUMAN OTC DRUG Certus Secure Hand Sanitizer BENZETHONIUM CHLORIDE LIQUID TOPICAL 20170327 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. BENZETHONIUM CHLORIDE 2 mg/mL N 20181231 75990-7008_ecba17ad-283a-422b-9d84-3a19cc9783c9 75990-7008 HUMAN OTC DRUG Certus Sting Relief Prep Pad BENZOCAINE SWAB TOPICAL 20110501 OTC MONOGRAPH FINAL part348 Certus Medical, Inc. BENZOCAINE .06 mL/mL N 20181231 75990-739_47805c9e-53ae-4704-bc29-785035b4e24a 75990-739 HUMAN OTC DRUG Palm CHLOROXYLENOL SOAP TOPICAL 20160819 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 75990-773_af64a9ac-a2cb-4f14-a187-5267d9730607 75990-773 HUMAN OTC DRUG Recens A ALCOHOL AEROSOL, FOAM TOPICAL 20110425 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL 620 mg/g N 20181231 75990-783_a192b620-ab5e-4cec-840c-94170240997f 75990-783 HUMAN OTC DRUG Recens Hand Sanitizer Wipes ALCOHOL CLOTH TOPICAL 20110923 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL 620 mg/g N 20181231 75990-793_b48fcfce-3dfb-451e-86cd-975688dd9aea 75990-793 HUMAN OTC DRUG Purgo Satin Foam TRICLOSAN SOAP TOPICAL 20171215 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. TRICLOSAN 3 mg/mL N 20181231 75990-959_5e1b2182-a1c9-480d-a262-04950a3f1d90 75990-959 HUMAN OTC DRUG Purgo Satin Foam TRICLOSAN SOAP TOPICAL 20131202 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. TRICLOSAN 3 mg/mL N 20181231 75990-968_8fdd46cf-4128-482f-81f2-0a87df1cb3b4 75990-968 HUMAN OTC DRUG Recens Foam ALCOHOL LIQUID TOPICAL 20110519 OTC MONOGRAPH NOT FINAL part333E Certus Medical, Inc. ALCOHOL .7 mL/mL N 20181231 75992-0004_bf218557-5d81-42ac-ba3c-20d75eccd9f4 75992-0004 HUMAN OTC DRUG Advantage Weight Loss and Hunger Control Natural Medicine LIQUID ORAL 20111207 UNAPPROVED HOMEOPATHIC Bouari Clinic ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; FUCUS VESICULOSUS; GRAPHITE; HELLEBORUS NIGER ROOT; BOS TAURUS HYPOTHALAMUS; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; THYROID, UNSPECIFIED; THYMUS SERPYLLUM 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 8; 8 [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL N 20181231 75997-011_5124e681-9799-49ef-b539-aba1c901e147 75997-011 HUMAN OTC DRUG Vanilla Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-012_30188485-116b-471b-a786-e23aae3a5a65 75997-012 HUMAN OTC DRUG Unscented Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-014_84bc30bc-8928-41e5-ba41-fde8c1d18a6e 75997-014 HUMAN OTC DRUG Raspberry Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-018_edcef76c-9b31-413f-aa7f-7ad9c3857d5e 75997-018 HUMAN OTC DRUG Vanilla Fig Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-019_a6218fc5-4437-4e87-b73c-d8a89e777bf5 75997-019 HUMAN OTC DRUG Pomegranate Rose Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-020_55a4d96b-9c52-4989-928d-4378119e14be 75997-020 HUMAN OTC DRUG Honeysuckle Ginger Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-021_9caf9ca3-3e12-4f84-b759-912bfb60249b 75997-021 HUMAN OTC DRUG Sunkissed Honeydew Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-022_f082cad4-665e-48cb-8e9f-6020d0fb595e 75997-022 HUMAN OTC DRUG Coconut Vanilla Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-023_de45a87c-9518-494a-9224-46475c880e54 75997-023 HUMAN OTC DRUG Aqua Sunset Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-024_5bba53fe-5954-4c79-9a46-04b7e11a1b57 75997-024 HUMAN OTC DRUG Lemon Lime Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-025_3a3c942c-5a75-4370-8795-9b85d9b25d15 75997-025 HUMAN OTC DRUG Strawberry Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-026_57ca0e0a-2d23-4ada-bf4a-e82e080a67d7 75997-026 HUMAN OTC DRUG Vanilla Hand Sanitizer with Vitamin E and Aloe ETHYL ALCOHOL LIQUID TOPICAL 20110202 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-027_47dfc2bd-f8d9-429e-aabb-39f7515448d3 75997-027 HUMAN OTC DRUG Gum Drop Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-028_c637b1c8-d2ae-45fa-aa71-a3fc73105c31 75997-028 HUMAN OTC DRUG Peppermint Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-029_9b154db6-3d76-446b-b25f-546869a62d55 75997-029 HUMAN OTC DRUG Frosted Berry Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110628 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. dba Noteworthy ALCOHOL 62 mL/100mL E 20171231 75997-030_ccfd5ae0-44a6-41bc-b0c8-8e0cccbb148d 75997-030 HUMAN OTC DRUG Hand Sanitizer Gift Set 3-pack ALCOHOL KIT 20110706 OTC MONOGRAPH NOT FINAL part333A Papermates, Inc. DBA Noteworthy E 20171231 76000-179_595445fb-4e15-443b-b3ed-73d2da14eedd 76000-179 HUMAN OTC DRUG St. Joseph Chewable Aspirin ASPIRIN TABLET, CHEWABLE ORAL 20120305 OTC MONOGRAPH NOT FINAL part343 Ilex Consumer Products Group, LLC ASPIRIN 81 mg/1 N 20181231 76000-231_eb2bcdef-55ff-4486-892f-15d2124d36ca 76000-231 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140530 OTC MONOGRAPH FINAL part343 Bedrock Brands, LLC (ST. JOSEPH) ASPIRIN 81 mg/1 N 20181231 76000-370_6d51f232-9a44-49f3-9f22-f0b3947c8daa 76000-370 HUMAN OTC DRUG Aspirin Aspirin TABLET, COATED ORAL 20120315 OTC MONOGRAPH FINAL part343 ILEX Consumer Products Group, LLC (ST. JOSEPH) ASPIRIN 325 mg/1 N 20181231 76000-375_de49316a-cd3e-4a21-9c7b-8ad17544c78b 76000-375 HUMAN OTC DRUG Anti Diarrheal Loperamide HCl TABLET ORAL 20050503 20190708 ANDA ANDA076497 Bedrock Brands, LLC LOPERAMIDE HYDROCHLORIDE 2 mg/1 E 20171231 76000-411_1b618184-d4d0-4cec-8e74-4cb18682168c 76000-411 HUMAN OTC DRUG Cough and Cold Relief HBP Chlorpheniramine maleate and Dextromethorphan HBr TABLET, SUGAR COATED ORAL 20030503 20190708 OTC MONOGRAPH FINAL part341 Bedrock Brands, LLC CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE 4; 30 mg/1; mg/1 E 20171231 76000-414_1ce9d337-cf7f-44ec-8edd-863260110482 76000-414 HUMAN OTC DRUG Adult Low Strength Aspirin Aspirin TABLET, COATED ORAL 20040114 20180527 OTC MONOGRAPH FINAL part343 Bedrock Brands, LLC ASPIRIN 81 mg/1 E 20171231 76000-460_6badd612-c101-41ce-a865-e6b0ccd1c12c 76000-460 HUMAN OTC DRUG High Blood Pressure Cold and Flu Acetaminophen and Chlorpheniramine Maleate TABLET, COATED ORAL 20050531 20180604 OTC MONOGRAPH NOT FINAL part343 Bedrock Brands, LLC ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE 325; 2 mg/1; mg/1 E 20171231 76000-461_c22b885c-93d1-4388-9647-051fb2366916 76000-461 HUMAN OTC DRUG Maximum Strength Flu HBP Acetaminophen, Dextromethorphan HBr, Chlorpheniramine maleate TABLET, FILM COATED ORAL 20050601 20190708 OTC MONOGRAPH FINAL part341 Bedrock Brands, LLC ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE 500; 15; 2 mg/1; mg/1; mg/1 E 20171231 76000-533_80971950-64a2-4e96-b2bf-56d415668629 76000-533 HUMAN OTC DRUG High Blood Pressure Chest Congestion and Cough Dextromethorphan HBr and Guaifenesin TABLET, FILM COATED ORAL 20051231 20190708 OTC MONOGRAPH FINAL part341 Bedrock Brands, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 400 mg/1; mg/1 E 20171231 76007-011_90411ee3-f9eb-463b-96d5-d2dc4b3e2dcd 76007-011 HUMAN OTC DRUG First Aid Pocket Pack - 40 Pieces BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE, ISOPROPYL ALCOHOL, BENZALKONIUM CHLORIDE KIT 20110204 OTC MONOGRAPH NOT FINAL part333A Ready America, Inc. E 20171231 76007-012_aeec6803-ea14-44db-8766-26dbc8185f69 76007-012 HUMAN OTC DRUG First Aid Value Pack - 77 Pieces BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE, ISOPROPYL ALCOHOL, BENZALKONIUM CHLORIDE KIT 20110204 OTC MONOGRAPH NOT FINAL part333A Ready America, Inc. E 20171231 76014-002_3e14fe43-ec4e-440b-afdc-8d1c74698664 76014-002 HUMAN PRESCRIPTION DRUG Bloxiverz Neostigmine Methylsulfate INJECTION INTRAVENOUS 20130724 NDA NDA204078 Avadel Legacy Pharmaceuticals, LLC NEOSTIGMINE METHYLSULFATE .5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 76014-003_3e14fe43-ec4e-440b-afdc-8d1c74698664 76014-003 HUMAN PRESCRIPTION DRUG Bloxiverz Neostigmine Methylsulfate INJECTION INTRAVENOUS 20130724 NDA NDA204078 Avadel Legacy Pharmaceuticals, LLC NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 76014-004_a5f393e5-0f07-462b-8878-8b3ac4b7aa21 76014-004 HUMAN PRESCRIPTION DRUG Vazculep Phenylephrine Hydrochloride INJECTION INTRAVENOUS 20140701 NDA NDA204300 Avadel Legacy Pharmaceuticals, LLC PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] N 20191231 76014-005_d7ea6982-e9ad-40f8-b2d6-a2d322a78359 76014-005 HUMAN PRESCRIPTION DRUG Akovaz ephedrine sulfate INJECTION INTRAVENOUS 20160801 NDA NDA208289 Avadel Legacy Pharmaceuticals, LLC EPHEDRINE SULFATE 50 mg/mL alpha-Adrenergic Agonist [EPC],Adrenergic alpha-Agonists [MoA],beta-Adrenergic Agonist [EPC],Adrenergic beta-Agonists [MoA],Norepinephrine Releasing Agent [EPC],Increased Norepinephrine Activity [PE] N 20181231 76014-902_0c9a078f-96c9-4f12-8eff-679ff10dcf3c 76014-902 HUMAN PRESCRIPTION DRUG Bloxiverz neostigmine methylsulfate INJECTION INTRAVENOUS 20130724 NDA NDA204078 Avadel Legacy Pharmaceuticals, LLC NEOSTIGMINE METHYLSULFATE .5 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 76014-903_0c9a078f-96c9-4f12-8eff-679ff10dcf3c 76014-903 HUMAN PRESCRIPTION DRUG Bloxiverz neostigmine methylsulfate INJECTION INTRAVENOUS 20130724 NDA NDA204078 Avadel Legacy Pharmaceuticals, LLC NEOSTIGMINE METHYLSULFATE 1 mg/mL Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] N 20181231 76015-110_3b771833-3f41-47d4-a408-c55d7ee8dd4f 76015-110 HUMAN OTC DRUG Dr Deep Deep Fresh GLYCERIN PASTE, DENTIFRICE DENTAL 20160812 OTC MONOGRAPH FINAL part347 MineralHouse Corporation GLYCERIN 7.68 g/120g E 20171231 76016-544_f6d5caf2-a745-4ac2-9c6b-6185578e7ee7 76016-544 HUMAN OTC DRUG Pure Kleen CHLOROXYLENOL SOAP TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333E Arrow-Magnolia International, Inc, CHLOROXYLENOL 3 mg/mL E 20171231 76017-100_480628ca-cffa-001b-e054-00144ff8d46c 76017-100 HUMAN OTC DRUG Australian Dream Pain Relieving Arthritis HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20110209 OTC MONOGRAPH NOT FINAL part348 Nature's Health Connection HISTAMINE DIHYDROCHLORIDE .025 g/100g N 20181231 76017-200_48bcfd05-5b0c-5c0b-e054-00144ff8d46c 76017-200 HUMAN OTC DRUG Australian Dream Back Pain HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20140710 OTC MONOGRAPH NOT FINAL part348 Nature's Health Connection HISTAMINE DIHYDROCHLORIDE .05 g/100g N 20181231 76017-769_433d86c2-c2cd-07fd-e054-00144ff88e88 76017-769 HUMAN OTC DRUG Australian Dream Carpal Tunnel Pain HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20161209 OTC MONOGRAPH NOT FINAL part348 Nature's Health Connection HISTAMINE DIHYDROCHLORIDE .025 g/100g N 20181231 76017-836_531ff07b-f21f-293d-e054-00144ff8d46c 76017-836 HUMAN OTC DRUG Australian Dream Hand and Wrist Pain HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20170628 OTC MONOGRAPH NOT FINAL part348 Nature’s Health Connection, Inc. HISTAMINE DIHYDROCHLORIDE .25 mg/g N 20181231 76018-100_48bc8512-f90b-451b-e054-00144ff8d46c 76018-100 HUMAN OTC DRUG Arth Arrest METHYL NICOTINATE, CAPSAICIN CREAM TOPICAL 20110211 OTC MONOGRAPH NOT FINAL part348 Key 2 Health, Inc. METHYL NICOTINATE; CAPSAICIN .5; .025 g/100g; g/100g N 20181231 76020-100_7a5e27d2-3c36-402e-ace4-cf2b6955e7ab 76020-100 HUMAN OTC DRUG HomeHealth Antifungal TOLNAFTATE LOTION TOPICAL 20110214 OTC MONOGRAPH FINAL part333C Home Health TOLNAFTATE 1 mL/100mL E 20171231 76020-200_4807f842-0970-0320-e054-00144ff88e88 76020-200 HUMAN OTC DRUG Home Health Everclean Antidandruff SALICYLIC ACID SHAMPOO TOPICAL 20110214 OTC MONOGRAPH FINAL part358H Home Health SALICYLIC ACID 1.8 g/100mL N 20181231 76020-300_4807fb60-8cee-6e61-e054-00144ff8d46c 76020-300 HUMAN OTC DRUG Home Health Psoriasis Medicated Scalp and Body Wash SALICYLIC ACID LIQUID TOPICAL 20110212 OTC MONOGRAPH FINAL part358H Home Health SALICYLIC ACID 2 g/100mL N 20181231 76020-400_48080129-a3ab-727f-e054-00144ff8d46c 76020-400 HUMAN OTC DRUG Home Health Psoriasis SALICYLIC ACID CREAM TOPICAL 20110213 OTC MONOGRAPH FINAL part358H Home Health SALICYLIC ACID 2 g/100g N 20181231 76026-200_172c35eb-36de-a788-1b1f-8bc5100b0f34 76026-200 HUMAN OTC DRUG puristics baby zinc oxide diaper rash zinc oxide CREAM TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part347 Scerene Healthcare, Inc. ZINC OXIDE 15 g/100g N 20181231 76026-204_60c21025-8be5-98d6-cf9a-bff672eb9224 76026-204 HUMAN OTC DRUG puristics totally ageless spf 15 daily anti-aging zinc oxide LOTION TOPICAL 20101220 OTC MONOGRAPH NOT FINAL part352 Scerene Healthcare, Inc. ZINC OXIDE 7.5 mL/100mL N 20181231 76026-304_5f4eb2f6-04e3-8103-88ea-bb3b615c8174 76026-304 HUMAN OTC DRUG puristics totallyageless spf 15 daily anti-aging octisalate, zinc oxide LOTION TOPICAL 20120101 OTC MONOGRAPH NOT FINAL part352 Scerene Healthcare, Inc. OCTISALATE; ZINC OXIDE 5; 3.75 mL/100mL; mL/100mL N 20181231 76029-001_6eb185c2-a897-4ae6-9c38-18f31e66ac60 76029-001 HUMAN OTC DRUG Pain Relief Ruta Graveolens CREAM TOPICAL 20110401 UNAPPROVED HOMEOPATHIC Active Release Techniques LLC RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/50g E 20171231 76029-002_9757bc14-c08d-41bb-a310-3d6c9fc11de7 76029-002 HUMAN OTC DRUG Nerve Pain Relief Capsicum CREAM TOPICAL 20110420 UNAPPROVED HOMEOPATHIC Active Release Techniques CAPSICUM 2 [hp_C]/50g E 20171231 76029-003_6b19cb05-d693-4975-abe9-25409fe02c9f 76029-003 HUMAN OTC DRUG Wound Healing Calendula Officinalis CREAM TOPICAL 20110420 UNAPPROVED HOMEOPATHIC Active Release Techniques CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_C]/35g E 20171231 76038-089_defa4f98-a2bd-4c36-84fd-23caf77f0020 76038-089 HUMAN OTC DRUG MEDITOWEL PAIN RELIEF MENTHOL CLOTH TOPICAL 20110101 OTC MONOGRAPH FINAL part348 MICRO CONNECTION ENTERPRISES INC MENTHOL .05 g/mL E 20171231 76038-090_cbfa3113-13e3-4a50-a02c-648266d4bbb3 76038-090 HUMAN OTC DRUG MEDITOWEL ILLUMINATING SKIN BRIGHTENING HYDROQUINONE CLOTH TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part358A MICRO CONNECTION ENTERPRISES INC HYDROQUINONE 2 g/100mL E 20171231 76038-091_c04c6bfd-96b5-4028-bd1a-b3f581b5931f 76038-091 HUMAN OTC DRUG MEDITOWEL ANTIBACTERIAL FIRST AID BENZOCAINE BENZALKONIUM CHLORIDE CLOTH TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part333B MICRO CONNECTION ENTERPRISES INC BENZOCAINE; BENZALKONIUM CHLORIDE 2; 2 mg/mL; mg/mL E 20171231 76045-001_41dff933-5a33-40a2-be6f-c2478438905d 76045-001 HUMAN PRESCRIPTION DRUG Midazolam Midazolam Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141003 ANDA ANDA203460 Fresenius Kabi USA, LLC MIDAZOLAM HYDROCHLORIDE 2 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 76045-002_41dff933-5a33-40a2-be6f-c2478438905d 76045-002 HUMAN PRESCRIPTION DRUG Midazolam Midazolam Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141003 ANDA ANDA203460 Fresenius Kabi USA, LLC MIDAZOLAM HYDROCHLORIDE 5 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 76045-003_41dff933-5a33-40a2-be6f-c2478438905d 76045-003 HUMAN PRESCRIPTION DRUG Midazolam Midazolam Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20141003 ANDA ANDA203460 Fresenius Kabi USA, LLC MIDAZOLAM HYDROCHLORIDE 10 mg/2mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV N 20181231 76045-004_e6f763a9-5c26-49fa-ab1e-09d9de9358cb 76045-004 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131030 NDA NDA204223 Fresenius Kabi, USA LLC MORPHINE SULFATE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 76045-005_e6f763a9-5c26-49fa-ab1e-09d9de9358cb 76045-005 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131030 NDA NDA204223 Fresenius Kabi, USA LLC MORPHINE SULFATE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 76045-006_e6f763a9-5c26-49fa-ab1e-09d9de9358cb 76045-006 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131030 NDA NDA204223 Fresenius Kabi, USA LLC MORPHINE SULFATE 5 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 76045-007_e6f763a9-5c26-49fa-ab1e-09d9de9358cb 76045-007 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131030 NDA NDA204223 Fresenius Kabi, USA LLC MORPHINE SULFATE 8 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 76045-008_e6f763a9-5c26-49fa-ab1e-09d9de9358cb 76045-008 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20131030 NDA NDA204223 Fresenius Kabi, USA LLC MORPHINE SULFATE 10 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 76045-009_bd31c2f1-653b-4369-95cb-f82c20ef2ba5 76045-009 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20161216 NDA NDA019034 Fresenius Kabi USA, LLC HYDROMORPHONE HYDROCHLORIDE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 76045-010_bd31c2f1-653b-4369-95cb-f82c20ef2ba5 76045-010 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20161216 NDA NDA019034 Fresenius Kabi USA, LLC HYDROMORPHONE HYDROCHLORIDE 2 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 76045-011_bd31c2f1-653b-4369-95cb-f82c20ef2ba5 76045-011 HUMAN PRESCRIPTION DRUG DILAUDID HYDROMORPHONE HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS 20161216 NDA NDA019034 Fresenius Kabi USA, LLC HYDROMORPHONE HYDROCHLORIDE 4 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 76045-101_41ebb054-9661-44ed-876c-39878e30ff70 76045-101 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130503 ANDA ANDA091392 Fresenius Kabi USA, LLC METOCLOPRAMIDE HYDROCHLORIDE 10 mg/2mL Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] N 20181231 76045-102_7c5017fe-18e0-4ba0-88c9-d636a8199f18 76045-102 HUMAN PRESCRIPTION DRUG Diphenhydramine Hydrochloride Diphenhydramine Hydrochloride INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20130326 ANDA ANDA091526 Fresenius Kabi USA, LLC DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] N 20181231 76045-103_f28e77c1-8e32-4f46-a0dd-f9bd0730ea27 76045-103 HUMAN PRESCRIPTION DRUG ONDANSETRON ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151210 ANDA ANDA202253 Fresenius Kabi USA, LLC ONDANSETRON HYDROCHLORIDE 4 mg/2mL Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 76045-104_ea33be62-684c-44e0-8cfe-f0287eb3025f 76045-104 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151102 ANDA ANDA203242 Fresenius Kabi USA, LLC KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 76045-105_ea33be62-684c-44e0-8cfe-f0287eb3025f 76045-105 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR 20151102 ANDA ANDA203242 Fresenius Kabi USA, LLC KETOROLAC TROMETHAMINE 60 mg/2mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 76045-106_56426d41-81ca-4b49-9a9d-07b74ec706a1 76045-106 HUMAN PRESCRIPTION DRUG Dexamethasone Sodium Phosphate Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE 20151030 ANDA ANDA203129 Fresenius Kabi USA, LLC DEXAMETHASONE SODIUM PHOSPHATE 4 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 76045-107_ea33be62-684c-44e0-8cfe-f0287eb3025f 76045-107 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20151102 ANDA ANDA203242 Fresenius Kabi USA, LLC KETOROLAC TROMETHAMINE 15 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 76045-108_2bc35680-f339-4630-b5b9-a89302496f95 76045-108 HUMAN PRESCRIPTION DRUG Heparin Sodium Heparin Sodium INJECTION, SOLUTION INTRAVENOUS; SUBCUTANEOUS 20160610 ANDA ANDA206552 Fresenius Kabi USA, LLC HEPARIN SODIUM 5000 [USP'U]/mL Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC] N 20181231 76049-121_89d9b005-7f25-436a-a976-38c75dab56b7 76049-121 HUMAN OTC DRUG jane Be Beautiful Multi-Benefit BB Broad Spectrum SPF 30 Dark OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20131031 OTC MONOGRAPH NOT FINAL part352 Stila Styles OCTINOXATE; ZINC OXIDE 50; 186 mg/mL; mg/mL N 20181231 76049-122_89d9b005-7f25-436a-a976-38c75dab56b7 76049-122 HUMAN OTC DRUG jane Be Beautiful Multi-Benefit BB Broad Spectrum SPF 30 Medium OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20131031 OTC MONOGRAPH NOT FINAL part352 Stila Styles OCTINOXATE; ZINC OXIDE 50; 186 mg/mL; mg/mL N 20181231 76049-123_89d9b005-7f25-436a-a976-38c75dab56b7 76049-123 HUMAN OTC DRUG jane Be Beautiful Multi-Benefit BB Broad Spectrum SPF 30 Light OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20131031 OTC MONOGRAPH NOT FINAL part352 Stila Styles OCTINOXATE; ZINC OXIDE 50; 186 mg/mL; mg/mL N 20181231 76049-554_0c87966d-a42a-45f3-9301-e38c61b37f7e 76049-554 HUMAN OTC DRUG stila bronzing tinted moisturizer oil-free SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20130831 OTC MONOGRAPH FINAL part347 Stila Styles, LLC TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 76049-555_cde70a36-38fa-44b4-9036-d6a5b1ea7a48 76049-555 HUMAN OTC DRUG Stila illuminating tinted moisturizer broad spectrum SPF 20 (All Shades) Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20130831 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 76049-556_2c27ca70-fb9b-4c9f-9c78-93f9a6dc7c03 76049-556 HUMAN OTC DRUG Stila Sheer color tinted moisturizer BS SPF20 (All Shades) Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20130831 OTC MONOGRAPH FINAL part347 Stila Styles, LLC TITANIUM DIOXIDE; ZINC OXIDE 50; 50 mg/mL; mg/mL N 20181231 76049-620_2b674434-a7bf-4d46-88b9-29cfbc5cfdf7 76049-620 HUMAN OTC DRUG stila illuminate and shine Octinoxate, Avobenzoate, and Octisalate KIT 20130831 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC E 20171231 76049-715_388fe1a5-c183-4bdd-a6ac-e491714c5161 76049-715 HUMAN OTC DRUG Stila Hydrating Primer Oil-Free SPF 30 (All Shades) Avobenzone, Octisalate, and Octinoxate LOTION TOPICAL 20130830 OTC MONOGRAPH FINAL part352 Stila Styles, LLC AVOBENZONE; OCTISALATE; OCTINOXATE 3; 5; 7.5 mg/mL; mg/mL; mg/mL N 20181231 76049-877_44d23dcb-2f83-4a53-b31c-a95ec6fc0c32 76049-877 HUMAN OTC DRUG Stila Stay All Day 10-in-1 HD Beauty Balm Broad Spectrum SPF 30 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20130831 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC OCTINOXATE; ZINC OXIDE 50; 186 mg/mL; mg/mL N 20181231 76049-879_41edcff8-9174-4870-9a70-dad66add9f83 76049-879 HUMAN OTC DRUG Stila Stay All Day 10-in-1 HD Illuminating Beauty Balm Broad Spectrum SPF 30 OCTINOXATE and ZINC OXIDE CREAM TOPICAL 20130831 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC OCTINOXATE; ZINC OXIDE 50; 186 mg/mL; mg/mL N 20181231 76049-899_e916e9be-077a-4f96-8bb9-ac6916f9d2ab 76049-899 HUMAN OTC DRUG Stila CC Color Correcting Broad-Spectrum SPF 20 (All Shades) Octocrylene, Octisalate, Avobenzone, and Octinoxate STICK TOPICAL 20130831 OTC MONOGRAPH FINAL part352 Stila Styles, LLC OCTOCRYLENE; OCTISALATE; AVOBENZONE; OCTINOXATE 40; 40; 15; 65 mg/g; mg/g; mg/g; mg/g E 20171231 76049-906_fd45043a-ca8a-4284-868d-f940b7b19f33 76049-906 HUMAN OTC DRUG Stila Color Correcting Broad Spectrum SPF 20 (All Shades) OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM TOPICAL 20130830 OTC MONOGRAPH NOT FINAL part352 Stila Styles, LLC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 75; 50; 10 mg/mL; mg/mL; mg/mL N 20181231 76053-001_6be7e206-e0d1-49a2-ad73-955dd8269be9 76053-001 HUMAN OTC DRUG Cargo Tinted Moisturizer SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20110412 OTC MONOGRAPH FINAL part352 Cargo Cosmetics Corp. TITANIUM DIOXIDE; ZINC OXIDE 2.5; 2.5 mL/mL; mL/mL N 20181231 76053-002_6be7e206-e0d1-49a2-ad73-955dd8269be9 76053-002 HUMAN OTC DRUG Cargo Tinted Moisturizer SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20110412 OTC MONOGRAPH FINAL part352 Cargo Cosmetics Corp. TITANIUM DIOXIDE; ZINC OXIDE 2.5; 2.5 mL/mL; mL/mL N 20181231 76053-003_6be7e206-e0d1-49a2-ad73-955dd8269be9 76053-003 HUMAN OTC DRUG Cargo Tinted Moisturizer SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20110412 OTC MONOGRAPH FINAL part352 Cargo Cosmetics Corp. TITANIUM DIOXIDE; ZINC OXIDE 2.5; 2.5 mL/mL; mL/mL N 20181231 76053-004_6be7e206-e0d1-49a2-ad73-955dd8269be9 76053-004 HUMAN OTC DRUG Cargo Tinted Moisturizer SPF 20 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20110412 OTC MONOGRAPH FINAL part352 Cargo Cosmetics Corp. TITANIUM DIOXIDE; ZINC OXIDE 2.5; 2.5 mL/mL; mL/mL N 20181231 76056-001_403da693-ab6f-4b45-ac4e-6c2fb3cb7a34 76056-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 19360101 UNAPPROVED MEDICAL GAS White's Inc. OXYGEN 99 L/100L E 20171231 76058-100_9ea6b4ad-4980-4f58-8d7d-1a2875fba5c9 76058-100 HUMAN OTC DRUG SIRINMEDI ONE SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110301 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 1460 mg/200g E 20171231 76058-101_a642700c-81e5-4575-8986-67e0925d8963 76058-101 HUMAN OTC DRUG Newchito Plus One SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110301 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 1452 mg/220g E 20171231 76058-102_57e835b1-883a-4da7-bf8d-206fe898166f 76058-102 HUMAN OTC DRUG Apatite SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110301 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 1380 mg/200g E 20171231 76058-103_af1e41b4-c82d-49c7-b516-5292ab890826 76058-103 HUMAN OTC DRUG Dental guardian SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110602 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 172 mg/25g E 20171231 76058-104_a6bab6a8-c93f-46ff-a1a4-64ed552d931a 76058-104 HUMAN OTC DRUG Cool Ice SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20010805 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 60 mg/120g E 20171231 76058-105_a8304627-38ab-4d59-9ef1-72c842c6b1fc 76058-105 HUMAN OTC DRUG Anti E-Sirin SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20111011 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 1460 mg/200g E 20171231 76058-106_22c417e4-da00-4acf-871f-9cbcd2a64f8c 76058-106 HUMAN OTC DRUG APATITE PROFESSIONAL CALCIUM CARBONATE PASTE DENTAL 20130314 UNAPPROVED DRUG OTHER Sungwon Pharmaceutical Co., Ltd. CALCIUM CARBONATE 36.4 g/130g E 20171231 76058-107_efd023ff-f0bd-4909-9efc-afd99ef57598 76058-107 HUMAN OTC DRUG ESIRIN X Sodium Monofluorophosphate PASTE DENTAL 20130331 OTC MONOGRAPH FINAL part355 Sungwon Pharmaceutical Co., Ltd. SODIUM MONOFLUOROPHOSPHATE 1.4 g/200g E 20171231 76063-738_fb0a4a4e-74e6-4d6d-ac52-ff2ea95e061b 76063-738 HUMAN OTC DRUG Handi-Sani ALCOHOL LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333E Chromate Industrial Corporation ALCOHOL .7 mL/mL E 20171231 76063-773_658bf66d-8bcd-4e13-89fa-514b7259ea1e 76063-773 HUMAN OTC DRUG Sani-Smooth ALCOHOL AEROSOL, FOAM TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333E Chromate Industrial Corporation ALCOHOL 620 mg/g E 20171231 76066-001_fdc5f262-151b-45ae-8e5c-c4ba982495a6 76066-001 HUMAN OTC DRUG EczeNil Colloidal Oatmeal CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part347 Healingsmith Institute Inc. OATMEAL 2.3 g/113.2g E 20171231 76066-002_c2fa9e06-b36b-4b7a-90d1-31628423a1b6 76066-002 HUMAN OTC DRUG PsoraCare Salicylic Acid CREAM TOPICAL 20120102 OTC MONOGRAPH FINAL part358H Healingsmith Institute Inc. SALICYLIC ACID 1.1 g/56.7g E 20171231 76069-100_48bcf889-139a-5557-e054-00144ff8d46c 76069-100 HUMAN OTC DRUG Arth RX Topical Analgesic METHYL NICOTINATE, CAPSAICIN LOTION TOPICAL 20110212 OTC MONOGRAPH NOT FINAL part348 HCD Sales METHYL NICOTINATE; CAPSAICIN .5; .025 g/100g; g/100g N 20181231 76070-100_0d3e268a-efe3-4641-894b-90a7d954a01c 76070-100 HUMAN OTC DRUG Bilboa Capri Sunscreen SPF 15 AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20110308 OTC MONOGRAPH FINAL part352 Cadey S.r.l. AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 5; 3; 2 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 76070-110_ecb642a6-8c81-48b9-96e2-aba76e934f31 76070-110 HUMAN OTC DRUG Bilboa Capri Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20110308 OTC MONOGRAPH FINAL part352 Cadey S.r.l. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 3; 2; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 76070-120_5659e368-7aa9-4e32-b43c-b5c9cec1e585 76070-120 HUMAN OTC DRUG Bilboa Capri Sunscreen SPF 50 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20110308 OTC MONOGRAPH FINAL part352 Cadey S.r.l. AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 13; 3; 2; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 76070-130_4bde1f2c-9b3f-4b8f-a43a-6902d4207a1f 76070-130 HUMAN OTC DRUG Bilboa Kids Sunscreen SPF 50 Plus HOMOSALATE, OCTISALATE, OXYBENZONE, ZINC OXIDE LOTION TOPICAL 20110308 OTC MONOGRAPH FINAL part352 Cadey S.r.l. HOMOSALATE; OCTISALATE; OXYBENZONE; ZINC OXIDE 13; 3; 6; 11.52 mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 76071-1001_b0d0e21d-fc62-4bd6-b94b-ed4b06d824d5 76071-1001 HUMAN OTC DRUG Stem Cell Renew adenosine CREAM TOPICAL 20110406 UNAPPROVED DRUG OTHER Medon Co., Ltd ADENOSINE .04 mL/mL E 20171231 76071-2001_423b475b-deff-44b4-9e3f-1b0df7d76666 76071-2001 HUMAN OTC DRUG Stem Cell Wrinkle Serum adenosine LIQUID TOPICAL 20110406 UNAPPROVED DRUG OTHER Medon Co., Ltd ADENOSINE .0004 mL/mL E 20171231 76071-3001_14cfdf50-cac6-4c94-83d8-ec7663ef920f 76071-3001 HUMAN OTC DRUG Stem Cell Whitening Serum NIACINAMIDE LIQUID TOPICAL 20110406 UNAPPROVED DRUG OTHER Medon Co., Ltd NIACINAMIDE .02 mL/mL E 20171231 76074-120_343e2c19-1c1f-4fa9-9d25-42e696869d67 76074-120 HUMAN OTC DRUG Topical Pain Relief Methyl Salicylate, Menthol, capsaicin CREAM TOPICAL 20110115 OTC MONOGRAPH NOT FINAL part348 Two Hip Consulting, LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 5; .0355 g/100g; g/100g; g/100g N 20181231 76074-122_dbc0dfeb-7813-4108-9e47-b36d0113fc69 76074-122 HUMAN OTC DRUG MEDI-SULTING TOPICAL PAIN RELIEF METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE CREAM TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part348 Two Hip Consulting, LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE 20; 5; .0355; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76074-123_945cd2df-841d-437e-8f18-8744522309fa 76074-123 HUMAN OTC DRUG MEDI-SULTING TOPICAL PAIN RELIEF METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE PATCH TOPICAL 20120818 OTC MONOGRAPH NOT FINAL part348 Two Hip Consulting, LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE 20; 5; .035; .5 g/100g; g/100g; g/100g; g/100g N 20181231 76074-135_ebea77d1-5dac-4cc0-b684-ed4ec92c476f 76074-135 HUMAN PRESCRIPTION DRUG LIDOCAINE LIDOCAINE OINTMENT TOPICAL 20160325 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC LIDOCAINE 5 g/100g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76074-151_35bc35b3-d6ae-4b75-8b7c-4e77c786238a 76074-151 HUMAN PRESCRIPTION DRUG MEDI-DERM RX METHYL SALICYLATE, MENTHOL AND CAPSAICIN CREAM TOPICAL 20120818 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 5; .035 g/100mL; g/100mL; g/100mL N 20181231 76074-152_1f008948-cec7-43af-ada8-edd357f72304 76074-152 HUMAN PRESCRIPTION DRUG MEDI-DERM / L WITH LIDOCAINE RX METHYL SALICYLATE MENTHOL CAPSAICIN LIDOCAINE CREAM TOPICAL 20120818 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE 20; 5; .0355; 4 g/100mL; g/100mL; g/100mL; g/100mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76074-153_8e8ddf61-2d9f-48b3-9b59-501c5e0a7d23 76074-153 HUMAN PRESCRIPTION DRUG MEDI-PATCH WITH LIDOCAINE RX CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE PATCH TOPICAL 20120818 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE 10; 2.5; .0175; .25 g/1; g/1; g/1; g/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76074-163_5eef63d6-6d5c-429d-9bad-0968b192bdc9 76074-163 HUMAN PRESCRIPTION DRUG MEDI-PATCH WITH LIDOCAINE RX CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE PATCH TOPICAL 20120818 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC METHYL SALICYLATE; MENTHOL; CAPSAICIN; LIDOCAINE 10; 2.5; .0175; .25 g/1; g/1; g/1; g/1 Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76074-501_28ef163a-9552-455e-99da-7076b810bd57 76074-501 HUMAN PRESCRIPTION DRUG Diclofenac Sodium Diclofenac Sodium GEL TOPICAL 20160325 UNAPPROVED DRUG OTHER Two Hip Consulting, LLC DICLOFENAC SODIUM 3 g/100g Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 76075-101_f5372352-a28d-407c-a986-2ee977eaadaa 76075-101 HUMAN PRESCRIPTION DRUG KYPROLIS carfilzomib INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20120720 NDA NDA202714 Onyx Pharmaceuticals, Inc. CARFILZOMIB 60 mg/30mL Proteasome Inhibitor [EPC],Proteasome Inhibitors [MoA] N 20191231 76075-102_f5372352-a28d-407c-a986-2ee977eaadaa 76075-102 HUMAN PRESCRIPTION DRUG KYPROLIS carfilzomib INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20160715 NDA NDA202714 Onyx Pharmaceuticals, Inc. CARFILZOMIB 30 mg/15mL Proteasome Inhibitor [EPC],Proteasome Inhibitors [MoA] N 20191231 76077-100_7889c1e5-b6bf-4e8f-bb70-a4f73ca9bbcc 76077-100 HUMAN OTC DRUG Novana Wash Perineal Skin Cleanser Benzethonium Chloride SOLUTION TOPICAL 20120404 OTC MONOGRAPH NOT FINAL part333E NOVANA MEDICAL LLC BENZETHONIUM CHLORIDE .001 mL/mL E 20171231 76077-200_041a4d30-30e6-4049-b74e-32e7a6529250 76077-200 HUMAN OTC DRUG Novana Moisturizing Dimethicone CREAM TOPICAL 20120404 OTC MONOGRAPH FINAL part347 NOVANA MEDICAL LLC DIMETHICONE .02 mL/mL E 20171231 76077-300_7dfb8b9c-ad7a-4ba9-bbc9-3e356fd002ae 76077-300 HUMAN OTC DRUG Novana Protect Barrier Zinc Oxide CREAM TOPICAL 20120404 OTC MONOGRAPH FINAL part352 NOVANA MEDICAL LLC ZINC OXIDE .12 mL/mL E 20171231 76077-400_34463f8e-014f-4ad5-80b3-ad5542a541bd 76077-400 HUMAN OTC DRUG Novana Antifungal Barrier with Miconazole Miconazole Nitrate CREAM TOPICAL 20120404 OTC MONOGRAPH FINAL part333C Novana Medical, LLC MICONAZOLE NITRATE .02 mL/mL E 20171231 76077-500_c0b20660-4e87-4171-9c70-b6192b224f2c 76077-500 HUMAN OTC DRUG Novana All-In-One One Step Perineal Dimethicone LOTION TOPICAL 20120404 OTC MONOGRAPH NOT FINAL part356 NOVANA MEDICAL LLC DIMETHICONE .02 mL/mL E 20171231 76079-001_eb06bf7a-9d16-4dc8-b541-2867adf0ad36 76079-001 HUMAN OTC DRUG Steiro BENZALKONIUM CHLORIDE LIQUID TOPICAL 20100101 OTC MONOGRAPH NOT FINAL part333A Bioblockade LLC BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 76081-010_18a4c3f0-c2d2-4cae-9389-444ad9c83393 76081-010 HUMAN OTC DRUG DAMOAE THERAPY PYRITHIONE ZINC SHAMPOO CUTANEOUS 20100801 OTC MONOGRAPH FINAL part358H DUALLIFE CO., LTD. PYRITHIONE ZINC 3 g/300g E 20171231 76081-020_ea25800d-87f4-4545-a28d-b9138f8b115e 76081-020 HUMAN OTC DRUG DAMOAE THERAPY TONIC SALICYLIC ACID SOLUTION TOPICAL 20110901 OTC MONOGRAPH FINAL part358H DUALLIFE CO., LTD. SALICYLIC ACID 2.4 mL/120mL E 20171231 76084-1001_0a3c59b4-be55-499e-a5f3-c755aa957ef2 76084-1001 HUMAN OTC DRUG Lancell hair loss prevention hair grower clean formula panthenol LIQUID TOPICAL 20110408 UNAPPROVED DRUG OTHER MICELLBio Co., Ltd PANTHENOL; PYRITHIONE ZINC; NIACINAMIDE; BIOTIN .005; .021; .003; .0006 mL/mL; mL/mL; mL/mL; mL/mL E 20171231 76084-2001_f6198b38-314f-438e-9df3-bcd74bf21080 76084-2001 HUMAN OTC DRUG Lancell hair loss prevention hair grower tonic SALICYLIC ACID LIQUID TOPICAL 20100408 UNAPPROVED DRUG OTHER MICELLBio Co., Ltd SALICYLIC ACID; NIACINAMIDE .005; .003 mL/mL; mL/mL E 20171231 76084-3001_ef3b1b6a-9976-4cc2-bdcf-c56e6798a988 76084-3001 HUMAN OTC DRUG Lancell Slimming lanthanum chloride GEL TOPICAL 20100819 UNAPPROVED DRUG OTHER MICELLBio Co., Ltd LANTHANUM; STYPOCAULON SCOPARIUM 2.5; 2 mL/100mL; mL/100mL E 20171231 76088-100_41ef7380-304d-4f30-b28a-38d35f3a4733 76088-100 HUMAN OTC DRUG Invisible Solid Xtreme Anti-Perspirant Deodorant ALUMINUM CHLOROHYDRATE STICK TOPICAL 20110302 OTC MONOGRAPH FINAL part350 King Import Warehouse ALUMINUM CHLOROHYDRATE 20 g/100g E 20171231 76088-101_4517f0e1-10ec-4025-bd6c-6ab894ce06a9 76088-101 HUMAN OTC DRUG Silky Smooth Anti-Perspirant Deodorant Invisible Solid ALUMINUM CHLOROHYDRATE STICK TOPICAL 20110302 OTC MONOGRAPH FINAL part350 King Import Warehouse ALUMINUM CHLOROHYDRATE 20 g/100g E 20171231 76088-200_70ea2053-c282-4798-9c44-b0250ef1e816 76088-200 HUMAN OTC DRUG Hand Antibacterial Premium TRICLOSAN SOAP TOPICAL 20110302 OTC MONOGRAPH NOT FINAL part333E King Import Warehouse TRICLOSAN .2 mL/100mL E 20171231 76088-300_c650de35-a75a-405e-baee-911b54a6581e 76088-300 HUMAN OTC DRUG Instant Hand Sanitizer Original ALCOHOL LIQUID TOPICAL 20110302 OTC MONOGRAPH NOT FINAL part333E King Import Warehouse ALCOHOL 62 mL/100mL E 20171231 76088-301_faaf8a92-a793-40ab-bde1-d45b4bd0f2de 76088-301 HUMAN OTC DRUG Instant Hand Sanitizer Original With Aloe Vera And Vitamin E ALCOHOL LIQUID TOPICAL 20110302 OTC MONOGRAPH NOT FINAL part333E King Import Warehouse ALCOHOL 62 mL/100mL E 20171231 76091-001_cfb1e46a-6a5a-40cd-ab80-0507876f5003 76091-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 20020101 UNAPPROVED MEDICAL GAS Isis Medical, Inc. OXYGEN 99 L/100L E 20171231 76092-101_fd8d9ad8-bfeb-49b9-90e7-37cf335a8cb5 76092-101 HUMAN OTC DRUG SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM Camphor, Menthol, Methyl Salicylate PATCH TOPICAL 20110701 OTC MONOGRAPH NOT FINAL part348 M J Winston International Ltd.. CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE 1.2; 5.7; 6.3 mg/1; mg/1; mg/1 N 20181231 76095-005_56f6be31-6fc4-092d-e054-00144ff8d46c 76095-005 HUMAN OTC DRUG Xpecto soothing relief Dextromethorphan HBr Guaifenesin Phenylephrine HCl SYRUP ORAL 20160509 OTC MONOGRAPH FINAL part341 MIDWAY IMPORTING INC GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 200; 10; 20 mg/10mL; mg/10mL; mg/10mL N 20181231 76095-010_649281d8-ea3b-3ca2-e053-2991aa0af6f7 76095-010 HUMAN OTC DRUG Cold Medicine XL3 FORTE Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride TABLET ORAL 20170801 OTC MONOGRAPH FINAL part341 MIDWAY IMPORTING INC. ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE 325; 4; 10 mg/1; mg/1; mg/1 N 20191231 76097-002_4e719a24-3424-4404-8416-852b7346d6ab 76097-002 HUMAN OTC DRUG Pollen Guard Grass Mix Grass Pollen Hay Fever Symptom Relief Anthoxanthum odaratum LIQUID ORAL 20111003 UNAPPROVED HOMEOPATHIC Western Allergy Services Ltd. ANTHOXANTHUM ODORATUM 1 [hp_X]/5mL E 20171231 76097-003_a57dc676-bf56-4bd3-a285-5d81c3366213 76097-003 HUMAN OTC DRUG Pollen Guard Ragweed Ragweed Hay Fever Symptom Relief Ambrosia Artemisiaefolia LIQUID ORAL 20111003 UNAPPROVED HOMEOPATHIC Western Allergy Services Ltd. AMBROSIA ARTEMISIIFOLIA 1 [hp_X]/5mL E 20171231 76097-004_a29d8b34-e132-4a33-8315-0c29c2882ffb 76097-004 HUMAN OTC DRUG Pollen Guard Weed Mix Weed Pollen Hay Fever Symptom Relief Plantago lanceolata LIQUID ORAL 20111003 UNAPPROVED HOMEOPATHIC Western Allergy Services Ltd. PLANTAGO LANCEOLATA POLLEN 1 [hp_X]/5mL E 20171231 76098-001_5669a828-7fe8-5d9b-e054-00144ff8d46c 76098-001 HUMAN OTC DRUG Sensitive Teeth Potassium nitrate PASTE ORAL 20170706 OTC MONOGRAPH NOT FINAL part356 The Green Beaver Company Ltd. POTASSIUM NITRATE 5 g/100mL N 20181231 76098-002_639da78b-4192-926b-e053-2a91aa0ab8bd 76098-002 HUMAN OTC DRUG The Green Beaver Company SPF 40 Kids Sunscreen sunscreen lotion LOTION TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part352 The Green Beaver Company ZINC OXIDE; TITANIUM DIOXIDE 8; 8 g/100g; g/100g N 20191231 76098-003_63a49b3f-de87-5397-e053-2991aa0a7a06 76098-003 HUMAN OTC DRUG The Green Beaver Company SPF 40 Kids Sunscreen sunscreen lotion LOTION TOPICAL 20180126 OTC MONOGRAPH NOT FINAL part352 The Green Beaver Company ZINC OXIDE; TITANIUM DIOXIDE 8; 8 g/100g; g/100g N 20191231 76102-100_480628ca-cfb0-001b-e054-00144ff8d46c 76102-100 HUMAN OTC DRUG Bakers Best Arthritis Pain Relief METHYL SALICYLATE, MENTHOL, LIDOCAINE HYDROCHLORIDE CREAM TOPICAL 20110210 OTC MONOGRAPH NOT FINAL part348 Baker's Best METHYL SALICYLATE; MENTHOL; LIDOCAINE HYDROCHLORIDE 4.5; 2.5; 1 g/100g; g/100g; g/100g N 20181231 76103-004_ba07fb8f-073f-4f5c-8961-3ba2877971a1 76103-004 HUMAN OTC DRUG Correct Dose Childrens Allergy Relief Diphenhydramine Hydrochloride LIQUID ORAL 20110615 OTC MONOGRAPH FINAL part341 BFS Pharma, Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL E 20171231 76105-479_b61ebcf6-dc18-493f-a569-492d30dbf4ca 76105-479 HUMAN OTC DRUG Eco SPF 30 Zinc Oxide LOTION TOPICAL 20110322 OTC MONOGRAPH FINAL part346 Eco Skin Care ZINC OXIDE 22 g/100g E 20171231 76105-525_61881ec0-07c6-4007-b445-1ed41851f5b5 76105-525 HUMAN OTC DRUG SPF 30 Face Zinc Oxide LOTION TOPICAL 20110322 OTC MONOGRAPH FINAL part346 Eco Skin Care ZINC OXIDE 20 g/100g E 20171231 76105-714_90b164dc-7c5b-4df1-9ca9-3d08569c7cf7 76105-714 HUMAN OTC DRUG All Natural Suncreen Zinc Oxide LOTION TOPICAL 20110322 OTC MONOGRAPH FINAL part346 Eco Skin Care ZINC OXIDE 22.5 g/100g E 20171231 76113-012_6123be18-1ee6-46bd-994e-f44b57b4cea4 76113-012 HUMAN OTC DRUG American Infection Control Antiseptic Hand Wipes Alcohol CLOTH TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E American Infection Control, Inc. ALCOHOL .62 mL/mL E 20171231 76113-012_f7f20fc3-e0d0-4954-ac59-208ea984d55f 76113-012 HUMAN OTC DRUG American Infection Control Antiseptic Hand Wipes Alcohol CLOTH TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E American Infection Control, Inc. ALCOHOL .62 mL/mL E 20171231 76113-112_d2a4d18d-8a38-498f-8cb9-f0bd8a76cd74 76113-112 HUMAN OTC DRUG American Infection Control Antiseptic Body Wipes Alcohol CLOTH TOPICAL 20120215 OTC MONOGRAPH NOT FINAL part333E American Infection Control, Inc. ALCOHOL .62 mL/mL E 20171231 76116-100_1d35322c-192f-4926-86d2-21720ec7b06a 76116-100 HUMAN OTC DRUG first depHense Alcohol-Free Antiseptic Foam Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110113 OTC MONOGRAPH FINAL part333E First Dephense, LLC BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 76117-001_a2362d50-4bb2-4ec9-864a-791a378618ad 76117-001 HUMAN OTC DRUG Rycontuss Cherry Flavor CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID ORAL 20110531 OTC MONOGRAPH FINAL part341 Okendpharma, Inc. CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 2; 10; 5 mg/5mL; mg/5mL; mg/5mL N 20181231 76118-0003_73fd8ca0-b938-4a92-8f6e-6df0279382ea 76118-0003 HUMAN OTC DRUG PURAX Aluminum Chloride Hexahydrate LIQUID TOPICAL 20140217 OTC MONOGRAPH FINAL part350 Purax International GmbH ALUMINUM CHLORIDE 15 mg/mL N 20181231 76119-1170_543156d2-2004-4809-9fda-72fa8979d1e4 76119-1170 HUMAN OTC DRUG mally Perfect Prep Poreless Primer Avobenzone, Octinoxate CREAM TOPICAL 20120329 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .6; 2.25 g/30mL; g/30mL N 20181231 76119-1211_e0928ce5-dca2-4604-b119-4cb78b6a9711 76119-1211 HUMAN OTC DRUG mally Poreless Perfection Glowing Foundation Fair OCTINOXATE, OXYBENZONE, ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20110317 OTC MONOGRAPH NOT FINAL part352 MallyGirl, LLC OCTINOXATE; OXYBENZONE; ZINC OXIDE; TITANIUM DIOXIDE 2.5; .8; 5; 7.5 g/100g; g/100g; g/100g; g/100g N 20181231 76119-1212_267f6706-d233-431e-984a-7f7b573d32b0 76119-1212 HUMAN OTC DRUG mally Poreless Perfection Glowing Foundation Light OCTINOXATE, OXYBENZONE, ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part352 MallyGirl, LLC OCTINOXATE; OXYBENZONE; ZINC OXIDE; TITANIUM DIOXIDE 2.5; .8; 5; 7.5 g/100g; g/100g; g/100g; g/100g N 20181231 76119-1213_f7d8acda-cd9a-4ef9-979c-0d860a87c841 76119-1213 HUMAN OTC DRUG mally Poreless Perfection Glowing Foundation Medium OCTINOXATE, OXYBENZONE, ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part352 MallyGirl, LLC OCTINOXATE; OXYBENZONE; ZINC OXIDE; TITANIUM DIOXIDE 2.5; .8; 5; 7.5 g/100g; g/100g; g/100g; g/100g N 20181231 76119-1214_0c6d3a63-0d87-4039-8d43-2f7afa1abf2e 76119-1214 HUMAN OTC DRUG mally Poreless Perfection Glowing Foundation Tan OCTINOXATE, OXYBENZONE, ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part352 MallyGirl, LLC OCTINOXATE; OXYBENZONE; ZINC OXIDE; TITANIUM DIOXIDE 2.5; .8; 5; 7.5 g/100g; g/100g; g/100g; g/100g N 20181231 76119-1215_65e35c36-a54f-4c33-9dfb-c5121c78f133 76119-1215 HUMAN OTC DRUG mally Poreless Perfection Glowing Foundation Rich OCTINOXATE, OXYBENZONE, ZINC OXIDE, TITANIUM DIOXIDE POWDER TOPICAL 20110323 OTC MONOGRAPH NOT FINAL part352 MallyGirl, LLC OCTINOXATE; OXYBENZONE; ZINC OXIDE; TITANIUM DIOXIDE 2.5; .8; 5; 7.5 g/100g; g/100g; g/100g; g/100g N 20181231 76119-1325_3014331a-7f13-41cf-9e3e-44113e5a2f47 76119-1325 HUMAN OTC DRUG mally Face Defender Foundation TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120329 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mL/53.2mL; mL/53.2mL N 20181231 76119-1326_2e9c2b9a-aee8-4e18-9ffe-afc1db4ca10b 76119-1326 HUMAN OTC DRUG mally Face Defender Foundation TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120329 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mL/53.2mL; mL/53.2mL N 20181231 76119-1327_6134846b-37d8-4411-a683-0ba9ca8698a1 76119-1327 HUMAN OTC DRUG mally Face Defender Foundation TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120329 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mL/53.2mL; mL/53.2mL N 20181231 76119-1328_9e518ddf-9ed6-49e0-94dd-d22e96f3c97f 76119-1328 HUMAN OTC DRUG mally Face Defender Foundation TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120329 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mL/53.2mL; mL/53.2mL N 20181231 76119-1329_cec26507-b11c-404c-b56b-ba4486090366 76119-1329 HUMAN OTC DRUG mally Face Defender Foundation TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20120329 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mL/53.2mL; mL/53.2mL N 20181231 76119-1440_debb8c13-91aa-4ed0-9c93-ce2bad2239ff 76119-1440 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL N 20181231 76119-1441_040b1272-ddd6-47fd-9a67-bf001c5635f0 76119-1441 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL N 20181231 76119-1442_6344cef0-4ce2-4343-86ce-beb371a77aab 76119-1442 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL N 20181231 76119-1443_f43df4fb-f834-4d53-af7c-50939b9a8dd3 76119-1443 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL N 20181231 76119-1444_20855b84-ad10-4599-aaa7-c3220e103d27 76119-1444 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL N 20181231 76119-1445_a65b3ae4-8b1c-4a87-b4cc-9529c1ea8d3f 76119-1445 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL N 20181231 76119-1446_b361e96a-6d3a-4673-9eaf-0f5f61426169 76119-1446 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL N 20181231 76119-1447_49b91377-dd77-4cd8-b09e-a055e74a8460 76119-1447 HUMAN OTC DRUG mally Face Defender Foundation BB TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20140203 OTC MONOGRAPH FINAL part352 MallyGirl, LLC TITANIUM DIOXIDE; ZINC OXIDE 2.39; 1.59 mg/53.2mL; mg/53.2mL N 20181231 76119-5305_e0107e7b-3575-471e-a011-5869c6a0d874 76119-5305 HUMAN OTC DRUG mally Lip Defender AVOBENZONE, OCTINOXATE GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .07; .245 g/3.5g; g/3.5g E 20171231 76119-5306_42aacbf3-7841-44f2-9d06-3601138aa376 76119-5306 HUMAN OTC DRUG mally Lip Defender AVOBENZONE, OCTINOXATE GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .07; .245 g/3.5g; g/3.5g E 20171231 76119-5307_edc9dc16-4785-4116-8c9e-061a0e0dbb17 76119-5307 HUMAN OTC DRUG mally Lip Defender AVOBENZONE, OCTINOXATE GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .07; .245 g/3.5g; g/3.5g E 20171231 76119-5308_f8f7e779-29ae-47f5-b3e9-9da1bfafac7b 76119-5308 HUMAN OTC DRUG mally Lip Defender AVOBENZONE, OCTINOXATE GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .07; .245 g/3.5g; g/3.5g E 20171231 76119-5309_9ae7fca0-2500-40f1-b5d9-0651c56176be 76119-5309 HUMAN OTC DRUG mally Lip Defender AVOBENZONE, OCTINOXATE GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .07; .245 g/3.5g; g/3.5g E 20171231 76119-5310_8fbc79be-ea92-486f-a37e-a5c52ed11b9f 76119-5310 HUMAN OTC DRUG mally Lip Defender AVOBENZONE, OCTINOXATE GEL TOPICAL 20120501 OTC MONOGRAPH FINAL part352 MallyGirl, LLC AVOBENZONE; OCTINOXATE .07; .245 g/3.5g; g/3.5g E 20171231 76123-120_7467de37-c515-4756-95c4-208e2619a0dc 76123-120 HUMAN OTC DRUG Alcohol Isopropyl Alcohol SWAB TOPICAL 20110405 OTC MONOGRAPH FINAL part344 School Health Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 76123-121_274e5756-531b-4605-8186-b659f30d747d 76123-121 HUMAN OTC DRUG School Health Sterile Alcohol Prep Pad Isopropyl Alcohol SWAB TOPICAL 20120503 OTC MONOGRAPH FINAL part344 School Health Corporation ISOPROPYL ALCOHOL .7 mL/mL N 20181231 76123-243_291e65e5-2e47-4a7f-8797-896c5c4001be 76123-243 HUMAN OTC DRUG BZK Cleansing Benzalkonium Chloride SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A School Health Corporation BENZALKONIUM CHLORIDE 1 mL/750mL N 20181231 76123-245_1032a9d1-e6f3-4722-845f-b011f451b0c7 76123-245 HUMAN OTC DRUG BZK Antiseptic Benzalkonium Chloride SWAB TOPICAL 20110405 OTC MONOGRAPH NOT FINAL part333A School Health Corporation BENZALKONIUM CHLORIDE 1 mL/750mL N 20181231 76125-150_eb48fe93-1631-4c28-8bbd-32117d88941c 76125-150 PLASMA DERIVATIVE KEDRAB HUMAN RABIES VIRUS IMMUNE GLOBULIN INJECTION, SOLUTION INTRAMUSCULAR 20171108 BLA BLA125613 Kedrion Biopharma Inc. HUMAN RABIES VIRUS IMMUNE GLOBULIN 150 [iU]/mL N 20181231 76125-250_9d91709d-2508-4708-9027-0377117e2320 76125-250 PLASMA DERIVATIVE Koate Antihemophilic Factor (Human) KIT 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC. N 20181231 76125-253_9d91709d-2508-4708-9027-0377117e2320 76125-253 PLASMA DERIVATIVE Koate Antihemophilic Factor (Human) KIT INTRAVENOUS 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC. N 20181231 76125-256_8ac87c28-3c44-4934-8d76-747f5df225ac 76125-256 PLASMA DERIVATIVE Koate ANTIHEMOPHILIC FACTOR (HUMAN) KIT INTRAVENOUS 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC. N 20181231 76125-257_8ac87c28-3c44-4934-8d76-747f5df225ac 76125-257 PLASMA DERIVATIVE Koate ANTIHEMOPHILIC FACTOR (HUMAN) KIT INTRAVENOUS 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC. N 20181231 76125-662_9d91709d-2508-4708-9027-0377117e2320 76125-662 PLASMA DERIVATIVE Koate Antihemophilic Factor (Human) KIT INTRAVENOUS 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC. N 20181231 76125-663_8ac87c28-3c44-4934-8d76-747f5df225ac 76125-663 PLASMA DERIVATIVE Koate ANTIHEMOPHILIC FACTOR (HUMAN) KIT INTRAVENOUS 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC. N 20181231 76125-667_9d91709d-2508-4708-9027-0377117e2320 76125-667 PLASMA DERIVATIVE Koate Antihemophilic Factor (Human) KIT 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC. N 20181231 76125-668_8ac87c28-3c44-4934-8d76-747f5df225ac 76125-668 PLASMA DERIVATIVE Koate ANTIHEMOPHILIC FACTOR (HUMAN) KIT INTRAVENOUS 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC. N 20181231 76125-672_9d91709d-2508-4708-9027-0377117e2320 76125-672 PLASMA DERIVATIVE Koate Antihemophilic Factor (Human) KIT 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC. N 20181231 76125-674_9d91709d-2508-4708-9027-0377117e2320 76125-674 PLASMA DERIVATIVE Koate Antihemophilic Factor (Human) KIT INTRAVENOUS 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC. N 20181231 76125-676_8ac87c28-3c44-4934-8d76-747f5df225ac 76125-676 PLASMA DERIVATIVE Koate ANTIHEMOPHILIC FACTOR (HUMAN) KIT INTRAVENOUS 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC. N 20181231 76125-678_8ac87c28-3c44-4934-8d76-747f5df225ac 76125-678 PLASMA DERIVATIVE Koate ANTIHEMOPHILIC FACTOR (HUMAN) KIT INTRAVENOUS 19990520 BLA BLA101130 KEDRION BIOPHARMA, INC. N 20181231 76125-783_958ccbfa-4a92-4fe0-8358-999100a820a1 76125-783 PLASMA DERIVATIVE Albuked Albumin (Human) SOLUTION INTRAVENOUS 19810728 BLA BLA101138 KEDRION BIOPHARMA, INC. ALBUMIN HUMAN 10 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 76125-784_6de8dbb3-0a40-4f04-9054-81444bac5830 76125-784 PLASMA DERIVATIVE Albuked Albumin (Human) SOLUTION INTRAVENOUS 19421021 BLA BLA101138 KEDRION BIOPHARMA, INC. ALBUMIN HUMAN 5 g/20mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 76125-785_eddd4478-99a9-4827-ba0b-17e04ba67454 76125-785 PLASMA DERIVATIVE Albuked Albumin (Human) SOLUTION INTRAVENOUS 19760826 BLA BLA101138 KEDRION BIOPHARMA, INC. ALBUMIN HUMAN .05 g/mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 76125-790_306ccbc6-6904-4ee3-90ae-394c131ca415 76125-790 PLASMA DERIVATIVE Albuked Albumin (Human) SOLUTION INTRAVENOUS 19760826 BLA BLA101138 KEDRION BIOPHARMA, INC. ALBUMIN HUMAN 2.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 76125-791_06223225-b68f-440c-8cb1-3038dca7f479 76125-791 PLASMA DERIVATIVE Albuked Albumin (Human) SOLUTION INTRAVENOUS 19810728 BLA BLA101138 KEDRION BIOPHARMA, INC. ALBUMIN HUMAN 10 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 76125-792_4581d1ac-0b92-4052-a527-ca9e3dc749f9 76125-792 PLASMA DERIVATIVE Albuked Albumin (Human) SOLUTION INTRAVENOUS 19421021 BLA BLA101138 KEDRION BIOPHARMA, INC. ALBUMIN HUMAN 5 g/20mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 76125-900_36a36d8e-a4ec-49f9-b587-6ed94954c7c3 76125-900 PLASMA DERIVATIVE GAMMAKED Immune Globulin (Human) INJECTION INTRAVENOUS; SUBCUTANEOUS 20101013 BLA BLA125046 KEDRION BIOPHARMA, INC. HUMAN IMMUNOGLOBULIN G 10 g/100mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 76125-918_f2d0d740-6f43-454c-9898-627be94f18e8 76125-918 PLASMA DERIVATIVE BIVIGAM HUMAN IMMUNOGLOBULIN G INJECTION, SOLUTION INTRAVENOUS 20130204 BLA BLA125389 KEDRION BIOPHARMA, INC. HUMAN IMMUNOGLOBULIN G 1 g/10mL Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] N 20181231 76126-072_9ef3da7e-bc38-46ee-b200-b317406495ba 76126-072 HUMAN PRESCRIPTION DRUG Sumatriptan Sumatriptan INJECTION SUBCUTANEOUS 20140415 ANDA ANDA203322 AGILA SPECIALTIES PRIVATE LIMITED SUMATRIPTAN SUCCINATE 6 mg/.5mL Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] E 20171231 76126-290_e729c612-2212-48c1-b510-359e3f5e0a84 76126-290 HUMAN PRESCRIPTION DRUG VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20110702 ANDA ANDA091469 AGILA SPECIALTIES PRIVATE LIMITED VANCOMYCIN HYDROCHLORIDE 10 g/100mL Glycopeptide Antibacterial [EPC],Glycopeptides [Chemical/Ingredient] E 20171231 76128-155_61516569-3359-4a2f-a791-8ad3ce03c979 76128-155 HUMAN PRESCRIPTION DRUG PHOTOFRIN porfimer sodium INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 19951227 NDA NDA020451 Pinnacle Biologics, Inc. PORFIMER SODIUM 75 mg/31.8mL Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE] E 20171231 76133-001_92609b03-2aea-4683-9d12-35558c7b46a6 76133-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20071001 NDA NDA205849 Praxair Distribution Mid-atlantic, Llc OXYGEN 990 mL/L E 20171231 76133-002_9134350b-43e2-4058-a529-cd2c393992be 76133-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20071001 UNAPPROVED MEDICAL GAS Praxair Distribution Mid-atlantic, Llc NITROGEN 990 mL/L E 20171231 76134-1111_76fa163e-73dd-4e91-8167-9cadf685d05c 76134-1111 HUMAN OTC DRUG Instant Hand Sanitizer alcohol GEL TOPICAL 20110518 OTC MONOGRAPH NOT FINAL part333E Stericycle, Inc. ALCOHOL 665 mL/L N 20181231 76138-001_1b91ac3e-2ded-413a-8293-0e1a1101ed36 76138-001 HUMAN OTC DRUG Antiseptic Hand Sanitizer Alcohol GEL TOPICAL 20110327 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties ALCOHOL 36.58 mL/59mL E 20171231 76138-101_ab0543ac-4b29-4c6e-94e6-265864c1d815 76138-101 HUMAN OTC DRUG Hand Sanitizer Alcohol SPRAY TOPICAL 20100505 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL E 20171231 76138-102_bf4238dc-fd42-446b-9f44-84f7f5a005e8 76138-102 HUMAN OTC DRUG Credit Card Shape Hand Sanitizer Alcohol SPRAY TOPICAL 20100505 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL E 20171231 76138-103_d81bea62-cd01-4dd7-bac4-4b16269186ec 76138-103 HUMAN OTC DRUG Compact Hand Sanitizer Alcohol GEL TOPICAL 20100505 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL E 20171231 76138-104_303a11ff-8301-49d3-87a7-d5c03932feec 76138-104 HUMAN OTC DRUG Hand Sanitizer w/Carabiner Alcohol GEL TOPICAL 20100505 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL E 20171231 76138-106_0acdc0af-86b0-47f1-854d-735f33eb18c9 76138-106 HUMAN OTC DRUG Compact Hand Sanitizer Alcohol GEL TOPICAL 20080505 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL E 20171231 76138-107_2f21302c-99ae-448b-ba10-53fe62cc1594 76138-107 HUMAN OTC DRUG Hand Sanitizer bottle with carabiner Alcohol LIQUID TOPICAL 20080505 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL E 20171231 76138-107_e142fcad-0cf3-48fb-92fd-a342fe55eec7 76138-107 HUMAN OTC DRUG Hand Sanitizer bottle with carabiner Alcohol LIQUID TOPICAL 20131015 OTC MONOGRAPH NOT FINAL part333A INNOVATION SPECIALTIES ALCOHOL 62 mL/100mL E 20171231 76138-111_9e970965-ca83-483a-a173-a000ff027637 76138-111 HUMAN OTC DRUG Antibacterial Hand Sanitizer Ethyl alcohol SPRAY TOPICAL 20140710 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties ALCOHOL 62 mL/100mL E 20171231 76138-111_d04669af-5e5c-444b-845b-70517ce382d8 76138-111 HUMAN OTC DRUG Antibacterial Hand Sanitizer Ethyl alcohol SPRAY TOPICAL 20140730 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties ALCOHOL 62 mL/100mL E 20171231 76138-112_3f988d0f-2616-407f-a2ec-d2342e966874 76138-112 HUMAN OTC DRUG Antibacterial Hand Sanitizer Ethyl alcohol SPRAY TOPICAL 20160102 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties Inc ALCOHOL 62 mL/100mL N 20191231 76138-112_94ec586d-5007-4aad-bbbe-06a80a2f4e61 76138-112 HUMAN OTC DRUG Antibacterial Hand Sanitizer Ethyl alcohol SPRAY TOPICAL 20160102 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties Inc ALCOHOL 62 mL/100mL N 20191231 76138-113_0c925083-58f7-409d-ba83-e9ab15c6f284 76138-113 HUMAN OTC DRUG Antiseptic Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160102 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties Inc ALCOHOL 62 mL/100mL N 20191231 76138-113_1efc31f6-ed73-4ae5-ae95-c9b77f2e5281 76138-113 HUMAN OTC DRUG Antiseptic Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160102 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties Inc ALCOHOL 62 mL/100mL N 20191231 76138-113_2d543ba6-96ef-45d3-8687-3051176debc2 76138-113 HUMAN OTC DRUG ANTISEPTIC HAND SANITIZER Ethyl Alcohol GEL TOPICAL 20160102 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties Inc ALCOHOL 62 mL/100mL N 20191231 76138-113_44912c16-d95f-42e6-9a5a-249f6757e433 76138-113 HUMAN OTC DRUG Antiseptic Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20160102 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties Inc ALCOHOL 62 mL/100mL N 20191231 76138-113_e9cf428f-2c2b-4edb-83f5-efc84b8debe3 76138-113 HUMAN OTC DRUG Antiseptic Hand Sanitizer Ethyl alcohol GEL TOPICAL 20160102 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties Inc ALCOHOL 62 mL/100mL N 20191231 76138-114_6a7d65dc-f6e5-4d49-8013-1a4fb0b945e3 76138-114 HUMAN OTC DRUG Hand Sanitizer Ethyl alcohol GEL TOPICAL 20160102 OTC MONOGRAPH NOT FINAL part333A Innovation Specialties Inc ALCOHOL 62 mL/100mL N 20191231 76138-115_2840371c-704a-44e5-ab9a-de5eee13bbd9 76138-115 HUMAN OTC DRUG 5247OP Hand Sanitizer Benzalkonium Chloride SPRAY TOPICAL 20180124 OTC MONOGRAPH NOT FINAL part333E Innovation Specialties Inc BENZALKONIUM CHLORIDE .1 g/100mL N 20191231 76138-201_aafeca9c-6b43-443e-b22c-26e2a6436407 76138-201 HUMAN OTC DRUG SPF 30 Sunscreen Tottle AVOBENZONE, OXYBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20091201 OTC MONOGRAPH NOT FINAL part352 INNOVATION SPECIALTIES AVOBENZONE; OXYBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 1; 3; 5; 7.5; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 76138-202_3ceedd56-d024-40d7-9df3-6398035dcc46 76138-202 HUMAN OTC DRUG SPF 30 Sunscreen Tottle w Carabiner AVOBENZONE, OXYBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE LOTION TOPICAL 20081201 OTC MONOGRAPH NOT FINAL part352 INNOVATION SPECIALTIES AVOBENZONE; OXYBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE 1; 3; 5; 7.5; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 76138-203_7a2b3590-021b-4796-9a8d-ad22703146cb 76138-203 HUMAN OTC DRUG SPF 30 Sunscreen OCTINOXATE, OXYBENZONE, OCTISALATE LOTION TOPICAL 20121001 OTC MONOGRAPH NOT FINAL part352 INNOVATION SPECIALTIES OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 1 g/100mL; g/100mL; g/100mL E 20171231 76138-204_43aa6fc2-8ea9-4795-8885-b3da02eee2bb 76138-204 HUMAN OTC DRUG SPF 30 Sunscreen Octinoxate, Oxybenzone, Octisalate, Titanium Dioxide LOTION TOPICAL 20130605 OTC MONOGRAPH NOT FINAL part352 INNOVATION SPECIALTIES OCTINOXATE; OXYBENZONE; OCTISALATE; TITANIUM DIOXIDE 7.5; 4; 2; 2.5 mg/mL; mg/mL; mg/mL; mg/mL E 20171231 76138-205_e940dc34-f5e5-472d-903f-0580ebe47165 76138-205 HUMAN OTC DRUG 5283 sunscreen Octinoxate, Octisalate, Oxybenzone, Titanium dioxide LOTION TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part352 Innovation Specialties OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 4; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76138-206_1f0dae9f-16ca-4ad9-a33c-50b62018468a 76138-206 HUMAN OTC DRUG 5298 sunscreen Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide LOTION TOPICAL 20170515 OTC MONOGRAPH NOT FINAL part352 Innovation Specialties OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 4; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76138-207_cb8c1781-c68d-4356-a06f-65bf8f905b4b 76138-207 HUMAN OTC DRUG 5281 sunscreen Octinoxate, Octisalate, Oxybenzone, Titanium dioxide LOTION TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Innovation Specialties OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7.5; 2; 4; 2.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76138-208_c4fd19af-02f4-4d88-ba6a-3ad42bf812d6 76138-208 HUMAN OTC DRUG 5281 sunscreen Octinoxate, Octisalate, Oxybenzone, Titanium dioxide LOTION TOPICAL 20170814 OTC MONOGRAPH NOT FINAL part352 Innovation Specialties OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7; 4; 3; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76138-209_6322c6f3-5b55-42ba-87db-5e65ae750fea 76138-209 HUMAN OTC DRUG 5407 sunscreen Octinoxate, Octisalate, Oxybenzone, Titanium dioxide LOTION TOPICAL 20170814 OTC MONOGRAPH NOT FINAL part352 Innovation Specialties OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7; 4; 3; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76138-210_86a876f8-e7de-4cfc-b65e-1ea96b5047cb 76138-210 HUMAN OTC DRUG 5298 sunscreen Octinoxate, Octisalate, Oxybenzone, Titanium dioxide LOTION TOPICAL 20170814 OTC MONOGRAPH NOT FINAL part352 Innovation Specialties OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7; 4; 3; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76138-211_0640f21e-5d5b-43f9-a790-11158696100c 76138-211 HUMAN OTC DRUG 5283 sunscreen Octinoxate, Octisalate, Oxybenzone, Titanium dioxide LOTION TOPICAL 20170814 OTC MONOGRAPH NOT FINAL part352 Innovation Specialties OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7; 4; 3; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76138-212_089006e8-c27c-47c1-9ba6-86d2f06a8bc5 76138-212 HUMAN OTC DRUG 5299 sunscreen Octinoxate,Octisalate,Oxybenzone,Titanium dioxide LOTION TOPICAL 20170916 OTC MONOGRAPH NOT FINAL part352 Innovation Specialties OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 7; 4; 3; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76140-105_c89c0e5d-c78a-41b2-84b6-33a32ffbb403 76140-105 HUMAN OTC DRUG Tussin CF Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride LIQUID ORAL 20130410 OTC MONOGRAPH FINAL part341 davAgen Pharmaceutical, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE 10; 100; 5 mg/5mL; mg/5mL; mg/5mL E 20171231 76140-106_0e6409bc-15a7-4d73-b4de-3952e31cb7f3 76140-106 HUMAN OTC DRUG Tussin DM Dextromethorphan Hydrobromide and Guaifenesin LIQUID ORAL 20130410 OTC MONOGRAPH FINAL part341 davAgen Pharmaceutical, LLC DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 100 mg/5mL; mg/5mL E 20171231 76144-000_60f0121e-81f0-5579-e053-2991aa0aa027 76144-000 HUMAN OTC DRUG PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE LOTION TOPICAL 20130411 OTC MONOGRAPH NOT FINAL part352 Paula's Choice, Inc TITANIUM DIOXIDE; ZINC OXIDE 23.2; 60 mg/mL; mg/mL N 20181231 76147-123_60f04f20-7a9a-c3c5-e053-2a91aa0a10a0 76147-123 HUMAN OTC DRUG StriVectin-SH NIA-114 UVA UVB Shields SPF 30 HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20110406 OTC MONOGRAPH FINAL part352 StriVectin Operating Company Inc. HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE; OXYBENZONE 75; 50; 30; 26; 20 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 76147-200_625bd205-4adb-52e1-e053-2991aa0ade0a 76147-200 HUMAN OTC DRUG Repair and Protect Moisturizer Broad Spectrum SPF30 AVOBENZONE, DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE CREAM TOPICAL 20150318 OTC MONOGRAPH NOT FINAL part352 Strivectin Operating Company, Inc. AVOBENZONE; DIMETHICONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 15; 50; 50; 27.9; 50 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 76147-210_6ec1d45c-aea3-4066-b02f-044144768fad 76147-210 HUMAN OTC DRUG StriVectin Clinical Corrector ADVANCED ANTI-AGING FACE TINT LIGHT OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20150323 OTC MONOGRAPH NOT FINAL part352 Strivectin Operating Company, Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 30; 80 mg/mL; mg/mL; mg/mL N 20181231 76147-211_8f112da9-6f57-4a29-86b7-8b096ad3bf29 76147-211 HUMAN OTC DRUG StriVectin Clinical Corrector ADVANCED ANTI-AGING FACE TINT MEDIUM OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20150325 OTC MONOGRAPH NOT FINAL part352 Strivectin Operating Company, Inc. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 75; 30; 80 mg/mL; mg/mL; mg/mL N 20181231 76147-220_61e39a80-e081-df89-e053-2991aa0aeae1 76147-220 HUMAN OTC DRUG StriVectin Clinical Corrector ANTI-AGING LIP TINT PINK Avobenzone, Octinoxate, Octocrylene CREAM TOPICAL 20150326 OTC MONOGRAPH NOT FINAL part352 Strivectin Operating Company, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 27; 30; 30 mg/mL; mg/mL; mg/mL N 20191231 76147-221_61e39a80-e08f-df89-e053-2991aa0aeae1 76147-221 HUMAN OTC DRUG StriVectin Clinical Corrector ANTI-AGING LIP TINT PLUM Avobenzone, Octinoxate, Octocrylene CREAM TOPICAL 20150326 OTC MONOGRAPH NOT FINAL part352 Strivectin Operating Company, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 27; 30; 30 mg/mL; mg/mL; mg/mL N 20191231 76147-230_625be3ed-9bb3-f65d-e053-2a91aa0adc6b 76147-230 HUMAN OTC DRUG StriVectin Advanced Retinol Day Moisturizer Broad Spectrum SPF30 Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone CREAM TOPICAL 20150407 OTC MONOGRAPH NOT FINAL part352 StriVectin Operating Company, Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 30; 75; 50; 27; 40 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL N 20191231 76150-111_56e50169-9416-0800-e054-00144ff8d46c 76150-111 HUMAN OTC DRUG Classic Body Plumeria SPF 30 Broad Spectrum Sunscreen LOTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories AVOBENZONE; OCTINOXATE 2; 2.25 g/100mL; g/100mL N 20181231 76150-112_56e42864-8626-5774-e054-00144ff8d46c 76150-112 HUMAN OTC DRUG Classic Moisturizing Body SPF 30 Broad Spectrum Sunscreen Unscented LOTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories AVOBENZONE; OCTINOXATE 2; 2.25 g/100mL; g/100mL N 20181231 76150-113_55deedc0-7f20-63c6-e054-00144ff88e88 76150-113 HUMAN OTC DRUG Fresh Cucumber Classic Face SPF 30 Broad Spectrum Sunscreen LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories OCTINOXATE; AVOBENZONE 2.1; 2 g/100mL; g/100mL N 20181231 76150-114_55f2e487-0e3c-15b1-e054-00144ff8d46c 76150-114 HUMAN OTC DRUG Unscented Classic Face SPF 30 Broad Spectrum Sunscreen LOTION TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories OCTINOXATE; AVOBENZONE 2.1; 2 g/100mL; g/100mL N 20181231 76150-117_50ebba5a-3c11-4e5e-e054-00144ff8d46c 76150-117 HUMAN OTC DRUG Unscented Body SPF 30 Broad Spectrum Classic Sunscreen SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. OCTOCRYLENE; OCTINOXATE; OCTISALATE; AVOBENZONE 7; 7.5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-118_45eb33f0-71e5-11d5-e054-00144ff88e88 76150-118 HUMAN OTC DRUG Citrus Mimosa Body SPF 30 Broad Spectrum Sunscreen Continuous Classic Sunscreen SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories OCTINOXATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 7.5; 2; 4; 7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-119_50eab20c-c3ec-1fa9-e054-00144ff8d46c 76150-119 HUMAN OTC DRUG Pina Colada Body SPF 30 Broad Spectrum Classic Sunscreen SPRAY TOPICAL 20130101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. OCTOCRYLENE; OCTISALATE; AVOBENZONE; OCTINOXATE 7; 4; 2; 7.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-120_5d69f494-f85b-ff75-e053-2a91aa0a8542 76150-120 HUMAN OTC DRUG Liplux Vanilla Peppermint SPF 15 Broad Spectrum Sunscreen LIPSTICK TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc OCTISALATE; AVOBENZONE 5; 3 g/100g; g/100g N 20181231 76150-121_5d6bcc7e-0363-6952-e053-2991aa0afe36 76150-121 HUMAN OTC DRUG LipLux Original SPF 30 Broad Spectrum Sunscreen LIPSTICK TOPICAL 20120401 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 7.25; 5; 2.8; 3 g/100g; g/100g; g/100g; g/100g N 20181231 76150-122_5bec6746-8978-1c22-e053-2a91aa0a797b 76150-122 HUMAN OTC DRUG Mineral Baby Unscented SPF 50 Broad Spectrum Sunscreen LOTION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc TITANIUM DIOXIDE; ZINC OXIDE 7.3; 4.3 g/100mL; g/100mL N 20181231 76150-123_5c391433-53e3-3f89-e053-2a91aa0a0659 76150-123 HUMAN OTC DRUG Mineral Face Rose Essence Tinted Moisturizer SPF 20 Broad Spectrum Sunscreen LOTION TOPICAL 20150501 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. TITANIUM DIOXIDE 4.2 g/100mL N 20181231 76150-125_5c3b1cce-f1dd-1ee0-e053-2a91aa0adfff 76150-125 HUMAN OTC DRUG Mineral Face Matte Cucumber SPF 30 Broad Spectrum Sunscreen LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. ZINC OXIDE; TITANIUM DIOXIDE 1.8; 3.2 g/100mL; g/100mL N 20181231 76150-126_5c3c4010-66f8-a554-e053-2991aa0ab992 76150-126 HUMAN OTC DRUG Mineral Face Matte Tint Unscented SPF 30 Broad Spectrum Sunscreen LOTION TOPICAL 20120601 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. TITANIUM DIOXIDE; ZINC OXIDE 3.2; 1.8 g/100mL; g/100mL N 20181231 76150-127_5be84f89-fb7b-80ea-e053-2991aa0a53a9 76150-127 HUMAN OTC DRUG Mineral Sport Citrus Mimosa SPF 30 Broad Spectrum Sunscreen LOTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc ZINC OXIDE; TITANIUM DIOXIDE 3.1; 4.8 g/100mL; g/100mL N 20181231 76150-133_19224370-5607-1c8c-e054-00144ff8d46c 76150-133 HUMAN OTC DRUG Kiss My Face Bare Naked Broad Spectrum SPF 30 Sunscreen AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories AVOBENZONE; OCTISALATE; OCTOCRYLENE; OCTINOXATE 2; 4; 7; 7.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-134_19308839-e376-42c0-e054-00144ff88e88 76150-134 HUMAN OTC DRUG Kiss My Face Cool Sport SPF 50 Broad Spectrum Sunscreen AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 10; 7.5; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-135_19327609-52b6-1621-e054-00144ff88e88 76150-135 HUMAN OTC DRUG Kiss My Face Kids Defense Broad Spectrum SPF 50 Sunscreen AEROSOL, SPRAY TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 3; 10; 7.5; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-136_1934aa81-a359-5bb4-e054-00144ff88e88 76150-136 HUMAN OTC DRUG Kiss My Face Babys First Kiss Mineral SPF 30 Broad Spectrum Sunscreen SPRAY, SUSPENSION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories TITANIUM DIOXIDE 7.8 g/100mL N 20181231 76150-137_19586871-dae8-4a57-e054-00144ff8d46c 76150-137 HUMAN OTC DRUG Kiss My Face Sport Mineral SPF 30 Broad Spectrum Sunscreen SPRAY, SUSPENSION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories TITANIUM DIOXIDE 7.8 g/100mL N 20181231 76150-138_1933fbea-5dd0-6c88-e054-00144ff8d46c 76150-138 HUMAN OTC DRUG Kiss My Face Kids Defense Mineral SPF 30 Broad Spectrum Sunscreen SPRAY, SUSPENSION TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories TITANIUM DIOXIDE 7.8 g/100mL N 20181231 76150-139_197000ce-433d-6499-e054-00144ff88e88 76150-139 HUMAN OTC DRUG Babys First Kiss SPF 50 Broad Spectrum Sunscreen LOTION TOPICAL 20150120 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories TITANIUM DIOXIDE 6 g/100mL N 20181231 76150-140_5c78017b-a86c-3388-e053-2a91aa0a468a 76150-140 HUMAN OTC DRUG Classic Sport Mango SPF 30 Broad Spectrum Sunscreen LOTION TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. OCTINOXATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE 4.7; 2.8; 4.9; 7.7 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-141_5c788c03-42fc-3af4-e053-2a91aa0a734a 76150-141 HUMAN OTC DRUG Classic Sport Unscented SPF 30 Broad Spectrum Sunscreen LOTION TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc OCTOCRYLENE; OCTINOXATE; AVOBENZONE; OCTISALATE 7.7; 4.7; 2.8; 4.9 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-142_33d5265e-b4fa-2d47-e054-00144ff88e88 76150-142 HUMAN OTC DRUG Sun Shield Clear SPF 30 Broad Spectrum Mineral Continuous Zinc Oxide SPF 30 Mineral SPRAY TOPICAL 20151201 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. ZINC OXIDE 12 g/100mL N 20181231 76150-143_33c532f4-c347-1c7c-e054-00144ff8d46c 76150-143 HUMAN OTC DRUG Sun Shield Clear SPF 50 Broad Spectrum Zinc Oxide Mineral SPF 50 STICK TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. ZINC OXIDE 17 g/100mL N 20181231 76150-148_2ea94e84-da46-1ab9-e054-00144ff88e88 76150-148 HUMAN OTC DRUG Tan Towel SPF 30 Bronzing Mist Broad Spectrum Sunscreen AEROSOL, SPRAY TOPICAL 20160321 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories OCTOCRYLENE; OCTINOXATE; OCTISALATE; AVOBENZONE 7; 7.5; 4; 2 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-149_2ebb2ada-1a05-017a-e054-00144ff8d46c 76150-149 HUMAN OTC DRUG Tan Towel SPF 30 Clear Broad Spectrum Sunscreen Spray AEROSOL, SPRAY TOPICAL 20160321 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories OCTISALATE; OCTOCRYLENE; AVOBENZONE; OCTINOXATE 3.9; 6.9; 1.9; 7.3 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-157_5b5f2880-da00-4362-e053-2991aa0a07db 76150-157 HUMAN OTC DRUG Classic Face Sport White Tea SPF 50 Broad Spectrum Sunscreen LOTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc OCTINOXATE; AVOBENZONE 6.25; 3 g/100mL; g/100mL N 20181231 76150-158_5c3d16dd-b0da-15aa-e053-2a91aa0a54e2 76150-158 HUMAN OTC DRUG Makeup Setting with Green Tea Aloe SPF 30 Broad Spectrum Sunscreen SPRAY TOPICAL 20150201 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc AVOBENZONE; HOMOSALATE; OCTISALATE 2.8; 3.5; 3.9 g/100mL; g/100mL; g/100mL N 20181231 76150-159_5bd51da9-429f-f670-e053-2a91aa0a95b3 76150-159 HUMAN OTC DRUG Rosilliance Medium/Dark SPF 30 Broad Spectrum Sunscreen LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc TITANIUM DIOXIDE 5.6 g/100mL N 20181231 76150-160_5b741036-5857-694d-e053-2991aa0a562e 76150-160 HUMAN OTC DRUG Rosillance Light/Medium SPF 30 Broad Spectrum Sunscreen LOTION TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc TITANIUM DIOXIDE 5.6 g/100mL N 20181231 76150-161_5bed2d4c-be8c-6d6f-e053-2a91aa0a7ac5 76150-161 HUMAN OTC DRUG Daydream Mineral Makeup Primer SPF 30 Broad Spectrum Sunscreen LOTION TOPICAL 20160501 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc TITANIUM DIOXIDE; ZINC OXIDE 2.5; 4 g/100mL; g/100mL N 20181231 76150-162_5c38acdb-b3df-020d-e053-2a91aa0a2466 76150-162 HUMAN OTC DRUG Classic Unscented SPF 15 Broad Spectrum Sunscreen AEROSOL TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc OCTOCRYLENE; AVOBENZONE; OCTINOXATE 6; 2; 4 g/100mL; g/100mL; g/100mL N 20181231 76150-163_5164a69f-ef39-088f-e054-00144ff88e88 76150-163 HUMAN OTC DRUG Classic Sport Unscented SPF 50 Broad Spectrum Classic Continuous SPRAY TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 3; 7.5; 10 g/100mL; g/100mL; g/100mL N 20181231 76150-164_50ec7ea0-58ae-4cb1-e054-00144ff88e88 76150-164 HUMAN OTC DRUG Guava Mango Sport SPF 30 Broad Spectrum Classic Sunscreen SPRAY TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE 3; 7.5; 10 g/100mL; g/100mL; g/100mL N 20181231 76150-165_516655cf-8761-01f2-e054-00144ff8d46c 76150-165 HUMAN OTC DRUG Fresh Cucumber Classic Body SPF 30 Broad Spectrum Sunscreen SPRAY TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. OCTOCRYLENE; AVOBENZONE; OCTISALATE; OCTINOXATE 7; 2; 4; 7.5 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-166_51668f07-4059-278c-e054-00144ff8d46c 76150-166 HUMAN OTC DRUG Tropical Coconut SPF 30 Broad Spectrum Classic Body Sunscreen SPRAY TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. AVOBENZONE; OCTOCRYLENE; OCTINOXATE; OCTISALATE 2; 7; 7.5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-180_5cc391be-ac82-4dca-e053-2a91aa0aedcc 76150-180 HUMAN OTC DRUG Mineral Lip Firecracker SPF 30 Broad Spectrum Sunscreen LIPSTICK TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. ZINC OXIDE; TITANIUM DIOXIDE 1.4; 2.8 g/100g; g/100g N 20181231 76150-181_5cc5c4ee-6da8-2da5-e053-2a91aa0aeb03 76150-181 HUMAN OTC DRUG Mineral Lip Nude Beach SPF 30 Broad Spectrum Sunscreen LIPSTICK TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. ZINC OXIDE; TITANIUM DIOXIDE 1.4; 3.8 g/100g; g/100g N 20181231 76150-182_5c8c8e61-f73f-2a8a-e053-2991aa0ad144 76150-182 HUMAN OTC DRUG Mineral Lip Tan Line SPF 30 Broad Spectrum Sunscreen LIPSTICK TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2.8; 1.4 g/100g; g/100g N 20181231 76150-183_5c8d6101-7f77-aa9a-e053-2a91aa0a99c5 76150-183 HUMAN OTC DRUG Mineral Lip Bonfire SPF 30 Broad Spectrum Sunscreen LIPSTICK TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. ZINC OXIDE; TITANIUM DIOXIDE 1.4; 2.8 g/100g; g/100g N 20181231 76150-184_5cc569d1-458b-10a7-e053-2a91aa0a9473 76150-184 HUMAN OTC DRUG Mineral Lip Skinny Dip SPF 30 Broad Spectrum Sunscreen LIPSTICK TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. ZINC OXIDE; TITANIUM DIOXIDE 1.4; 2.8 g/100g; g/100g N 20181231 76150-185_5cc7f065-d072-3117-e053-2991aa0a15f1 76150-185 HUMAN OTC DRUG Mineral Lip Summer Crush SPF 30 Broad Spectrum Sunscreen LIPSTICK TOPICAL 20160401 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. TITANIUM DIOXIDE; ZINC OXIDE 2.8; 1.4 g/100g; g/100g N 20181231 76150-203_5bd8cb5b-6613-5885-e053-2a91aa0a60d5 76150-203 HUMAN OTC DRUG Rosilliance Golden Tint SPF 30 Broad Spectrum Sunscreen LOTION TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc TITANIUM DIOXIDE 5.6 g/100mL N 20181231 76150-204_5c64e6cd-580c-2c32-e053-2991aa0a7d63 76150-204 HUMAN OTC DRUG Grapefruit SPF 30 Broad Spectrum Sunscreen AEROSOL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. OCTOCRYLENE; AVOBENZONE; OCTINOXATE; OCTISALATE 6.6; 1.9; 7.1; 3.9 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-205_5c656c6f-9be5-1c76-e053-2a91aa0a5999 76150-205 HUMAN OTC DRUG Pear SPF 30 Broad Spectrum Sunscreen AEROSOL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 7.1; 3.9; 6.6; 1.9 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-206_5c65bdc8-a94b-325c-e053-2991aa0a5dcd 76150-206 HUMAN OTC DRUG Pineapple SPF 30 Broad Spectrum Sunscreen AEROSOL TOPICAL 20161101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. OCTINOXATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 7.1; 3.9; 1.9; 6.6 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76150-207_5c008e11-ea31-6fbd-e053-2991aa0a951f 76150-207 HUMAN OTC DRUG Dawn Patrol Classic Makeup Primer SPF 30 Broad Spectrum Sunscreen LOTION TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc AVOBENZONE; OCTOCRYLENE; OCTISALATE 1.9; 7.6; 4 g/100mL; g/100mL; g/100mL N 20181231 76150-208_5cc873cc-1733-7a5d-e053-2a91aa0a4e08 76150-208 HUMAN OTC DRUG Mineral Sport Golden Tint SPF 50 Broad Spectrum Sunscreen STICK TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. ZINC OXIDE 20 g/100g N 20181231 76150-209_5cde5748-5223-c890-e053-2991aa0a71ef 76150-209 HUMAN OTC DRUG Mineral Sport Stick Untinted SPF 50 Broad Spectrum Sunscreen STICK TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. ZINC OXIDE 20 g/100g N 20181231 76150-210_5d069775-9806-06e3-e053-2991aa0a7ee4 76150-210 HUMAN OTC DRUG Mineral Baby SPF 50 Broad Spectrum Sunscreen STICK TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Bell International Laboratories, Inc. ZINC OXIDE 20 g/100g N 20181231 76151-105_60eef35a-1523-9408-e053-2a91aa0a888a 76151-105 HUMAN OTC DRUG Oil-Free Daily Hydration SPF 15 OCTINOXATE, AVOBENZONE CREAM TOPICAL 20110416 OTC MONOGRAPH FINAL part352 Boscia LLC OCTINOXATE; AVOBENZONE 50; 30 mg/mL; mg/mL N 20191231 76151-106_60ef2018-65de-c33c-e053-2a91aa0ad219 76151-106 HUMAN OTC DRUG Boscia Daily Hydration SPF 15 Broad Spectrum For Normal To Oily Skin AVOBENZONE, OCTINOXATE CREAM TOPICAL 20121108 OTC MONOGRAPH FINAL part352 Boscia LLC AVOBENZONE; OCTINOXATE 30; 60 mg/mL; mg/mL N 20181231 76151-207_60ef0018-b0c6-6131-e053-2a91aa0ab85e 76151-207 HUMAN OTC DRUG Restorative Day Moisture SPF 15 OCTINOXATE, AVOBENZONE CREAM TOPICAL 20110416 OTC MONOGRAPH FINAL part352 Boscia LLC OCTINOXATE; AVOBENZONE 50; 30 mg/mL; mg/mL N 20191231 76151-210_60ef2018-65f0-c33c-e053-2a91aa0ad219 76151-210 HUMAN OTC DRUG Boscia BB SPF 27 PA TITANIUM DIOXIDE CREAM TOPICAL 20110511 OTC MONOGRAPH FINAL part352 Boscia LLC TITANIUM DIOXIDE 6.4 g/100g N 20181231 76151-211_60ef147d-0071-c5c4-e053-2a91aa0ac419 76151-211 HUMAN OTC DRUG Boscia BB Broad Spectrum SPF 27 PA Self Adjusting Shade TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20121107 OTC MONOGRAPH FINAL part352 Boscia LLC TITANIUM DIOXIDE; ZINC OXIDE 10.02; .97 g/100g; g/100g N 20181231 76151-217_60eef35a-1511-9408-e053-2a91aa0a888a 76151-217 HUMAN OTC DRUG Boscia Restorative Day Moisture Broad Spectrum SPF 15 For Dry Skin AVOBENZONE, OCTINOXATE CREAM TOPICAL 20121116 OTC MONOGRAPH NOT FINAL part352 Boscia LLC AVOBENZONE; OCTINOXATE 30; 65 mg/mL; mg/mL N 20181231 76151-221_60ef147d-0092-c5c4-e053-2a91aa0ac419 76151-221 HUMAN OTC DRUG Boscia BB BRONZE Broad Spectrum SPF 27 PA Self-Adjusting Shade TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20121107 OTC MONOGRAPH FINAL part352 Boscia LLC TITANIUM DIOXIDE; ZINC OXIDE 7.55; .98 g/100g; g/100g N 20181231 76151-231_60ef0018-b0d8-6131-e053-2a91aa0ab85e 76151-231 HUMAN OTC DRUG Boscia B.B. LIGHT Broad Spectrum SPF 27 PA Self-Adjusting Shade TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20121106 OTC MONOGRAPH FINAL part352 Boscia LLC TITANIUM DIOXIDE; ZINC OXIDE 11.25; .98 g/100g; g/100g N 20181231 76151-241_60ef3722-014b-7177-e053-2991aa0a9f72 76151-241 HUMAN OTC DRUG Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PA OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20121107 OTC MONOGRAPH FINAL part352 Boscia LLC OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 7.25; 5.742; 4.75 g/100g; g/100g; g/100g N 20181231 76151-251_60ef3519-3f19-ee6a-e053-2a91aa0ab9e4 76151-251 HUMAN OTC DRUG Boscia Self-Defense Vital Antioxidant Moisture Broad Spectrum SPF 30 AVOBENZONE, OCTINOXATE CREAM TOPICAL 20121103 OTC MONOGRAPH FINAL part352 Boscia LLC AVOBENZONE; OCTINOXATE 30; 75 mg/mL; mg/mL N 20181231 76151-261_60ef3d14-a4e9-8188-e053-2991aa0a6df6 76151-261 HUMAN OTC DRUG Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20 TITANIUM DIOXIDE CREAM TOPICAL 20140410 OTC MONOGRAPH NOT FINAL part352 Boscia LLC TITANIUM DIOXIDE 6.45 g/100g N 20181231 76159-001_60ee8b00-dca6-f29d-e053-2991aa0a5c23 76159-001 HUMAN OTC DRUG 3LAB PERFECT BB SPF 40 Broad Spectrum 01 TITANIUM DIOXIDE CREAM TOPICAL 20130110 OTC MONOGRAPH FINAL part352 3LAB, Inc TITANIUM DIOXIDE 121.6 mg/mL N 20181231 76159-002_60ee479d-1127-8bf0-e053-2991aa0af5c5 76159-002 HUMAN OTC DRUG 3LAB PERFECT BB SPF 40 Broad Spectrum 02 TITANIUM DIOXIDE CREAM TOPICAL 20130110 OTC MONOGRAPH FINAL part352 3LAB, Inc TITANIUM DIOXIDE 121.6 mg/mL N 20181231 76159-003_60eebe40-8ef3-c8a3-e053-2991aa0aca9f 76159-003 HUMAN OTC DRUG 3LAB PERFECT BB SPF 40 Broad Spectrum 03 TITANIUM DIOXIDE CREAM TOPICAL 20130110 OTC MONOGRAPH FINAL part352 3LAB, Inc TITANIUM DIOXIDE 77.2 mg/mL N 20181231 76159-004_60ee8b00-dcb9-f29d-e053-2991aa0a5c23 76159-004 HUMAN OTC DRUG 3LAB Aqua BB SPF 40 BROAD SPECTRUM 01 TITANIUM DIOXIDE CREAM TOPICAL 20131118 OTC MONOGRAPH NOT FINAL part352 3LAB, Inc. TITANIUM DIOXIDE 78.6 mg/mL N 20181231 76159-005_60eebe40-8f04-c8a3-e053-2991aa0aca9f 76159-005 HUMAN OTC DRUG 3LAB Aqua BB SPF 40 BROAD SPECTRUM 02 TITANIUM DIOXIDE CREAM TOPICAL 20131118 OTC MONOGRAPH NOT FINAL part352 3LAB, Inc. TITANIUM DIOXIDE 78.6 mg/mL N 20181231 76159-006_60eec70e-cce4-31fa-e053-2a91aa0a28a1 76159-006 HUMAN OTC DRUG 3LAB Aqua BB SPF 40 BROAD SPECTRUM 03 TITANIUM DIOXIDE CREAM TOPICAL 20131118 OTC MONOGRAPH NOT FINAL part352 3LAB, Inc. TITANIUM DIOXIDE 78.6 mg/mL N 20181231 76159-124_60ee8b00-dc85-f29d-e053-2991aa0a5c23 76159-124 HUMAN OTC DRUG 3LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen OCTINOXATE, OCTISALATE, AVOBENZONE CREAM TOPICAL 20121015 OTC MONOGRAPH FINAL part352 3LAB, Inc OCTINOXATE; OCTISALATE; AVOBENZONE 75; 46; 2 mg/mL; mg/mL; mg/mL N 20181231 76159-204_60a5dc14-3f83-8414-e053-2991aa0ad34a 76159-204 HUMAN OTC DRUG 3LAB WW DAY SPF40 BROAD SPECTRUM Homosalate, Octisalate,Avobenzone,Octocrylene CREAM TOPICAL 20160527 OTC MONOGRAPH NOT FINAL part352 3LAB OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE 50; 30; 100; 26 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 76159-234_60ee8b00-dc96-f29d-e053-2991aa0a5c23 76159-234 HUMAN OTC DRUG 3LAB PERFECT Lite Sunscreen SPF 30 Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110415 OTC MONOGRAPH FINAL part352 3LAB, Inc TITANIUM DIOXIDE; ZINC OXIDE 24.8; 60 mg/mL; mg/mL N 20181231 76159-345_60eeaf53-188e-24b9-e053-2a91aa0ae135 76159-345 HUMAN OTC DRUG 3LAB PERFECT Sunscreen SPF 50 Plus Broad Spectrum HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20110421 OTC MONOGRAPH FINAL part352 3LAB, Inc HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 100; 50; 30; 26 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 76161-001_7e1fa295-a007-4597-a00c-58ab2f0f7e29 76161-001 HUMAN OTC DRUG Alcohol Prep ISOPROPYL ALCOHOL SWAB TOPICAL 20110420 OTC MONOGRAPH NOT FINAL part333A KYJ Medical Products Co.,Ltd. ISOPROPYL ALCOHOL .7 mL/1 E 20171231 76162-101_a9a4c1e7-d75b-4cda-b1f2-2fb3ae714095 76162-101 HUMAN OTC DRUG Antibacterial Antibacterial LIQUID TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333E Topco Associates LLC TRICLOSAN .476 mL/340mL E 20171231 76162-102_a9a4c1e7-d75b-4cda-b1f2-2fb3ae714095 76162-102 HUMAN OTC DRUG Antibacterial Antibacterial LIQUID TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333E Topco Associates LLC TRICLOSAN .476 mL/340mL E 20171231 76162-103_a9a4c1e7-d75b-4cda-b1f2-2fb3ae714095 76162-103 HUMAN OTC DRUG Antibacterial Antibacterial LIQUID TOPICAL 20060101 OTC MONOGRAPH NOT FINAL part333E Topco Associates LLC TRICLOSAN .476 mL/340mL E 20171231 76162-809_0a96632e-984d-4503-82c9-16b2db07403f 76162-809 HUMAN OTC DRUG Alcohol Prep Isopropyl Alcohol SWAB TOPICAL 20110713 OTC MONOGRAPH NOT FINAL part333A Topco Associates ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 76163-010_75e7420a-7f83-4fb4-b6a5-c242fecc0ba5 76163-010 HUMAN OTC DRUG DR.OH PATCH CAMPHOR (NATURAL) PATCH CUTANEOUS 20110201 OTC MONOGRAPH NOT FINAL part348 YEPHARM CAMPHOR (NATURAL); MENTHOL 28.4; 16 mg/2000mg; mg/2000mg E 20171231 76166-001_2b8b55cf-347b-4675-bf90-ce0e67071052 76166-001 HUMAN OTC DRUG ELF Personal Blend Foundation SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 Shanghai Justking Enterprise Co. Ltd. TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; g/100g E 20171231 76166-002_186327da-050b-4e68-ab44-e7ed34d29140 76166-002 HUMAN OTC DRUG ELF Mineral Moisturizing Lip Tint SPF 8 TITANIUM DIOXIDE POWDER TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 Shanghai Justking Enterprise Co. Ltd. TITANIUM DIOXIDE 4 g/100g E 20171231 76167-001_1148ea39-fe60-4c27-bd40-181fd492fabf 76167-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 FLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION INTRAVENOUS 20141112 ANDA ANDA204385 Children's Hospital of Michigan FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 76167-002_c849e41b-ab04-4c4b-a055-57e87ce42915 76167-002 HUMAN PRESCRIPTION DRUG Sodium FluorideF 18 F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20120612 UNAPPROVED DRUG OTHER Children's Hospital of Michigan SODIUM FLUORIDE F-18 200 mg/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 76167-003_248c7653-7014-48fd-98df-998225515102 76167-003 HUMAN PRESCRIPTION DRUG AmmoniaN 13 N 13 AMMONIA N-13 INJECTION INTRAVENOUS 20120130 UNAPPROVED DRUG OTHER Children's Hospital of Michigan AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 76168-009_5a83ea7c-214c-4a89-9e10-dede03f58db3 76168-009 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20110401 OTC MONOGRAPH NOT FINAL part343 Velocity Pharma ASPIRIN 81 mg/1 N 20181231 76168-010_b3795b58-f7b7-4a62-89c8-23d11e38f44c 76168-010 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET ORAL 20121205 OTC MONOGRAPH NOT FINAL part343 Velocity Pharma ACETAMINOPHEN 500 mg/1 N 20181231 76168-011_e0595668-bbee-4f87-92cb-2a987105d2c0 76168-011 HUMAN OTC DRUG Pain Relief PM Acetaminophen PM TABLET ORAL 20121205 OTC MONOGRAPH NOT FINAL part343 Velocity Pharma ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE 500; 25 mg/1; mg/1 N 20181231 76168-012_62377580-5148-43ee-936f-0624149301d7 76168-012 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, COATED ORAL 20120701 ANDA ANDA091239 Velocity Pharma IBUPROFEN 200 mg/1 N 20181231 76168-013_43b59cca-632b-5ff3-e054-00144ff88e88 76168-013 HUMAN OTC DRUG Allergy Diphenhydramine Hydrochloride TABLET ORAL 20120512 OTC MONOGRAPH FINAL part341 Velocity Pharma DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 76168-021_240453b0-189a-401e-9f2e-2bf977f7aaa6 76168-021 HUMAN OTC DRUG Pain Reliever Fever Reducer Acetaminophen,Dextromethorphan hydrobromide,Phenylephrine Hydrochloride,Chlorpheniramine Maleate TABLET, EFFERVESCENT ORAL 20140815 OTC MONOGRAPH FINAL part341 Velocity Pharma ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE 250; 10; 5; 2 mg/1; mg/1; mg/1; mg/1 N 20181231 76168-054_49d9e42a-312f-4afa-e054-00144ff88e88 76168-054 HUMAN OTC DRUG Lidocaine Pain Relieving Creme Lidocaine Hydrochloride CREAM TOPICAL 20170303 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC LIDOCAINE HYDROCHLORIDE 4 g/100g N 20181231 76168-055_b3bacaef-5dd7-4237-a327-ed4ee33274ee 76168-055 HUMAN OTC DRUG DayTime Cold and Flu Acetaminophen,Dextromethorphan,Phenylephrine CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH FINAL part341 Velocity Pharma ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE 325; 10; 5 mg/1; mg/1; mg/1 N 20181231 76168-056_58ee90a2-07a9-2253-e053-2a91aa0ad9cf 76168-056 HUMAN OTC DRUG NightTime Cold and Flu Acetaminophen,Dextromethorphan,Doxylamine CAPSULE, LIQUID FILLED ORAL 20140501 OTC MONOGRAPH FINAL part341 Velocity Pharma ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE 325; 15; 6.25 mg/1; mg/1; mg/1 N 20181231 76168-057_f905bb92-063f-4b40-882d-f2e4514d8d8b 76168-057 HUMAN OTC DRUG DAYTIME NIGHTTIME COLD/FLU acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl KIT ORAL 20140715 OTC MONOGRAPH FINAL part341 Velocity Pharma N 20181231 76168-060_ff9770f5-a51c-4488-9708-d50bd3e2fcfa 76168-060 HUMAN OTC DRUG Cough and Congestion DM Dextromethorphan and Guaifenesin CAPSULE, LIQUID FILLED ORAL 20151108 OTC MONOGRAPH FINAL part341 Velocity Pharma DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 10; 200 mg/1; mg/1 E 20171231 76168-064_1f5a9653-ad96-4723-8ec2-4e0815495c66 76168-064 HUMAN OTC DRUG Menstrual Relief Acetaminophen,Caffeine,Pyrilamine TABLET ORAL 20130501 OTC MONOGRAPH NOT FINAL part343 Velocity Pharma ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE 500; 60; 15 mg/1; mg/1; mg/1 N 20181231 76168-065_29c54705-6caf-4aef-afb9-7996d286e886 76168-065 HUMAN OTC DRUG Nightime Sleep Aid Diphenhydramine CAPSULE, LIQUID FILLED ORAL 20140331 OTC MONOGRAPH FINAL part341 Velocity Pharma DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1 E 20171231 76168-066_3699cb9c-31a9-43ef-981a-0a35c910a0e4 76168-066 HUMAN OTC DRUG ZzzSleep Diphenhydramine CAPSULE, LIQUID FILLED ORAL 20131015 OTC MONOGRAPH FINAL part341 Velocity Pharma DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 76168-067_4a16cbc7-24c4-6aa0-e054-00144ff8d46c 76168-067 HUMAN OTC DRUG Maximum strength Lidocaine Patch Lidocaine PATCH TOPICAL 20170306 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC LIDOCAINE 40 mg/1 N 20181231 76168-069_5d5cb3d5-4364-4980-93b0-c75f5c482601 76168-069 HUMAN OTC DRUG Stool Softener Docusate Sodium CAPSULE, LIQUID FILLED ORAL 20130401 OTC MONOGRAPH NOT FINAL part334 Velocity Pharma DOCUSATE SODIUM 100 mg/1 N 20181231 76168-099_49da2f87-9520-74e8-e054-00144ff8d46c 76168-099 HUMAN OTC DRUG Hot and Cold Lidocaine with Menthol Patch Pain Relief lidocaine and menthol PATCH TOPICAL 20170303 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC LIDOCAINE; MENTHOL 40; 10 mg/1; mg/1 N 20181231 76168-100_49c5bd9a-c418-72d7-e054-00144ff88e88 76168-100 HUMAN OTC DRUG Hot and Cold with Lidocaine Pain Relieving Lidocaine HCl and Menthol CREAM TOPICAL 20170302 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC LIDOCAINE; MENTHOL .4; .1 g/g; g/g N 20181231 76168-108_49b0ece6-584a-7133-e054-00144ff8d46c 76168-108 HUMAN OTC DRUG Pain Relieving Arthritis HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20170301 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC HISTAMINE DIHYDROCHLORIDE .025 g/100g N 20181231 76168-200_5928b81a-d868-8805-e053-2a91aa0acdfe 76168-200 HUMAN OTC DRUG Hot and Cold Cream with Lidocaine- RA Pain Relieving Lidocaine HCl and Menthol CREAM TOPICAL 20170914 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC LIDOCAINE; MENTHOL .4; .1 g/g; g/g N 20181231 76168-201_5928833c-a1bb-58bd-e053-2a91aa0a4c59 76168-201 HUMAN OTC DRUG Lidocaine Pain Relieving Creme Lidocaine Hydrochloride CREAM TOPICAL 20170914 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC LIDOCAINE HYDROCHLORIDE 4 g/100g N 20181231 76168-300_506e9e32-22d7-0c25-e054-00144ff88e88 76168-300 HUMAN OTC DRUG Pain Relieving Arthritis HISTAMINE DIHYDROCHLORIDE CREAM TOPICAL 20170526 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC HISTAMINE DIHYDROCHLORIDE .025 g/100g N 20181231 76168-301_5059b79b-2edb-51f7-e054-00144ff8d46c 76168-301 HUMAN OTC DRUG Hot and Cold Cream with Lidocaine- RA Pain Relieving Lidocaine HCl and Menthol CREAM TOPICAL 20170525 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC LIDOCAINE; MENTHOL .4; .1 g/g; g/g N 20181231 76168-302_505c6f72-1b27-6236-e054-00144ff8d46c 76168-302 HUMAN OTC DRUG Hot and Cold Lidocaine with Menthol Patch Pain Relief lidocaine and menthol PATCH TOPICAL 20170303 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC LIDOCAINE; MENTHOL 40; 10 mg/1; mg/1 N 20181231 76168-304_59a35d43-d368-10a3-e053-2991aa0a64de 76168-304 HUMAN OTC DRUG Hot and Cold Lidocaine with Menthol Patch Pain Relief lidocaine and menthol PATCH TOPICAL 20170303 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC LIDOCAINE; MENTHOL 40; 10 mg/1; mg/1 N 20181231 76168-305_59a35d43-d35b-10a3-e053-2991aa0a64de 76168-305 HUMAN OTC DRUG Maximum strength Lidocaine Patch Lidocaine PATCH TOPICAL 20170526 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC LIDOCAINE 40 mg/1 N 20181231 76168-400_6388bd05-0ed7-fc29-e053-2a91aa0a5c55 76168-400 HUMAN OTC DRUG Hot and Cold Cream with Lidocaine- RA Pain Relieving Lidocaine HCl and Menthol CREAM TOPICAL 20180122 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC LIDOCAINE; MENTHOL .4; .1 g/g; g/g N 20191231 76168-401_63884688-d735-a321-e053-2991aa0aff14 76168-401 HUMAN OTC DRUG Cold Zone Pain Relieving Gel- DG Health MENTHOL GEL TOPICAL 20180122 OTC MONOGRAPH NOT FINAL part348 Velocity Pharma LLC MENTHOL 40 mg/mL N 20191231 76169-101_241123ca-09c0-4e37-a685-38dde5f3639e 76169-101 HUMAN OTC DRUG Renewing Antioxidant Treatment SPF 6 GNLD International Octyl Methoxycinnamate, Avobenzone CREAM TOPICAL 20110422 OTC MONOGRAPH FINAL part352 GNLD International OCTINOXATE; AVOBENZONE 6; 1.7 g/100g; g/100g E 20171231 76169-102_cf904722-59f7-422d-89f0-8d64009585e1 76169-102 HUMAN OTC DRUG Renewing Antioxidant Treatment SPF 6 GNLD International Avobenzone, Octyl Methoxycinnamate CREAM TOPICAL 20140801 OTC MONOGRAPH FINAL part352 GNLD International OCTINOXATE; AVOBENZONE 6; 1.7 g/100g; g/100g N 20181231 76170-101_47fb2ea9-27da-2057-f277-834e1d982b01 76170-101 HUMAN OTC DRUG Dentree sodium fluoride GEL, DENTIFRICE DENTAL 20120401 OTC MONOGRAPH FINAL part355 e-soup Co., Ltd. SODIUM FLUORIDE .22 g/1000mL E 20171231 76170-102_ad16ca7f-43be-bcfb-2aa3-87bd5d7f5fdf 76170-102 HUMAN OTC DRUG Dentree sodium fluoride GEL, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 e-soup Co., Ltd. SODIUM FLUORIDE .22 g/100mL E 20171231 76170-103_1d0e5655-c373-06cd-d387-8a2e10d3a0fc 76170-103 HUMAN OTC DRUG Dentree sodium fluoride GEL, DENTIFRICE DENTAL 20121201 OTC MONOGRAPH FINAL part355 e-soup Co., Ltd. SODIUM FLUORIDE .22 g/100mL E 20171231 76173-1001_7c58d52c-941e-4806-8348-388e1b92c62f 76173-1001 HUMAN OTC DRUG Rendrevie Sun Screen SPF35 PA OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20110720 OTC MONOGRAPH NOT FINAL part352 Cellinbio Co Ltd OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 5.625; 3.89; 2.25 mL/75mL; mL/75mL; mL/75mL E 20171231 76173-1002_1aab8317-c273-439c-a159-f92e8f1d2f76 76173-1002 HUMAN OTC DRUG BONNOIR HAIR MEDI PYRITHIONE ZINC, PANTHENOL, NIACINAMIDE, BIOTIN SHAMPOO TOPICAL 20110727 UNAPPROVED DRUG OTHER Cellinbio Co Ltd PYRITHIONE ZINC; PANTHENOL; NIACINAMIDE; BIOTIN 7.35; 1.75; 1.05; .21 mL/350mL; mL/350mL; mL/350mL; mL/350mL E 20171231 76173-1003_3eaf2422-e6e7-45ed-afbd-8dd677ce8e7e 76173-1003 HUMAN OTC DRUG Vita Fresh SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110727 OTC MONOGRAPH FINAL part355 Cellinbio Co Ltd SODIUM MONOFLUOROPHOSPHATE 1.125 g/150g E 20171231 76173-1004_442dec39-3f85-4b5d-9fe9-fecc13372abb 76173-1004 HUMAN OTC DRUG The Cellin EOP B.B Cream TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE EMULSION TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part352 Cellinbio Co Ltd TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.556; 1.2; .768 mL/40mL; mL/40mL; mL/40mL E 20171231 76173-1005_fc97a0da-00cc-4efb-b6ec-7017df10d2d3 76173-1005 HUMAN OTC DRUG SUYAN CHUNGSOO ARBUTIN, GLYCERIN LIQUID TOPICAL 20111007 OTC MONOGRAPH FINAL part347 Cellinbio Co Ltd ARBUTIN; GLYCERIN .26; .26 mL/130mL; mL/130mL E 20171231 76173-1006_9c2a55f2-eeb5-4280-a063-470b625c8371 76173-1006 HUMAN OTC DRUG SUYAN CHUNGSYU ARBUTIN, GLYCERIN EMULSION TOPICAL 20111108 OTC MONOGRAPH FINAL part347 Cellinbio Co Ltd GLYCERIN; ARBUTIN 4.9; 2.6 mL/130mL; mL/130mL E 20171231 76173-1007_379cbc65-9c8a-4c51-80bc-f6458432c8ea 76173-1007 HUMAN OTC DRUG SUYAN JEONGBAEK GLYCERIN, ARBUTIN CREAM TOPICAL 20111109 OTC MONOGRAPH FINAL part347 Cellinbio Co Ltd GLYCERIN; ARBUTIN 4.8; 1 mL/50mL; mL/50mL E 20171231 76173-1008_87edc4e4-ccea-4fd2-a258-5b2e5bbbf108 76173-1008 HUMAN OTC DRUG SUYAN JEONGDAN TEA TREE OIL SOAP TOPICAL 20111212 UNAPPROVED DRUG OTHER Cellinbio Co Ltd TEA TREE OIL .5 g/100g E 20171231 76173-1100_568e8df7-60d0-4b07-966e-ec01a306507b 76173-1100 HUMAN OTC DRUG The Cellin SC BB Cream SPF 25 PA TITANIUM DIOXIDE CREAM TOPICAL 20130828 OTC MONOGRAPH NOT FINAL part352 Cellinbio Co Ltd TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 6.39; 3; 1.92 g/30g; g/30g; g/30g E 20171231 76173-1101_cc4a811c-1c63-47a8-80bb-3fd5d02b9c88 76173-1101 HUMAN OTC DRUG THE CELLIN SUN SCREEN SPF35 PA PLUS PLUS Octinoxate, Titanium Dioxide, Octisalate CREAM TOPICAL 20140801 OTC MONOGRAPH NOT FINAL part352 Cellinbio Co Ltd OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 5.62; 3.89; 2.25 mg/75mL; mg/75mL; mg/75mL E 20171231 76174-100_e903affc-b833-4294-ab5c-0d4b11d135ea 76174-100 HUMAN OTC DRUG Scape SPF 50 Athlete Sunblock AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20110422 OTC MONOGRAPH FINAL part352 Nupur Formulations Inc AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 6; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 76174-110_3f6fcaf8-0226-4391-b58c-200b79ff9cb1 76174-110 HUMAN OTC DRUG Scape SPF 30 Athlete Sunblock AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE LOTION TOPICAL 20110422 OTC MONOGRAPH FINAL part352 Nupur Formulations Inc AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 6; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 76174-120_b567e06e-965a-45c7-974c-10ff1c9b11e4 76174-120 HUMAN OTC DRUG 2X Sunblock SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE LIQUID TOPICAL 20110422 OTC MONOGRAPH FINAL part352 Nupur Formulations Inc AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OXYBENZONE 3; 15; 6; 6 mL/100mL; mL/100mL; mL/100mL; mL/100mL N 20181231 76174-130_c7b93248-4907-4add-887e-b606a0a0e217 76174-130 HUMAN OTC DRUG Scape SPF 50 Moisturizing Face AVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20110422 OTC MONOGRAPH FINAL part352 Nupur Formulations Inc AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 3; 10; 5; 6; 6 g/100g; g/100g; g/100g; g/100g; g/100g N 20181231 76174-140_518c5edb-652c-4695-9097-7524edcab3fd 76174-140 HUMAN OTC DRUG SCAPE SPF 30 LIP BALM AVOBENZONE, OCTINOXATE, OCTISALATE,OCTOCRYLENE, OXYBENZONE STICK TOPICAL 20110427 OTC MONOGRAPH FINAL part352 Nupur Formulations Inc AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE 2; 7.5; 5; 6; 5 g/100g; g/100g; g/100g; g/100g; g/100g E 20171231 76176-000_3297ca9d-9dff-25e1-e054-00144ff88e88 76176-000 HUMAN OTC DRUG Le Vital Japanese Cherry Blossom Ethyl Alcohol GEL TOPICAL 20160509 OTC MONOGRAPH NOT FINAL part333E Ningbo Liyuan Daily Chemical Products Co., Ltd. ALCOHOL 62 g/100g N 20181231 76176-001_32967da6-b695-0048-e054-00144ff88e88 76176-001 HUMAN OTC DRUG Le Vital Moon to Light ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Ningbo Liyuan Daily Chemical Products Co., Ltd. ALCOHOL 62 g/100g N 20181231 76176-003_582ae543-a5f2-4fad-9cee-765ef78d507a 76176-003 HUMAN OTC DRUG SANITAXE HAND SANITIZER LIQUID TOPICAL 20140731 OTC MONOGRAPH NOT FINAL part333A NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD ALCOHOL 62 mL/100mL N 20181231 76176-005_330bdc6c-0dda-3a96-e054-00144ff8d46c 76176-005 HUMAN OTC DRUG Le Vital Vanilla Heaven ethyl alcohol GEL TOPICAL 20160511 OTC MONOGRAPH NOT FINAL part333E Ningbo Liyuan Daily Chemical Products Co., Ltd. ALCOHOL 62 g/100g N 20181231 76176-017_b1b6f9cd-d97f-4788-a761-8bc0a9e2ccf6 76176-017 HUMAN OTC DRUG PHARMACYS PRESCRIPTION ANALGESIC GEL TOPICAL 20140101 OTC MONOGRAPH FINAL part346 NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD MENTHOL 1 g/100g N 20181231 76176-018_d26db1fe-d788-4175-b933-dc4cb597fb3c 76176-018 HUMAN OTC DRUG PHARMACYS PRESCRIPTION VAPOR RUB GEL TOPICAL 20140101 OTC MONOGRAPH FINAL part346 NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD MENTHOL 1 g/100g N 20181231 76176-031_605d26d2-ace6-0d33-e053-2a91aa0af154 76176-031 HUMAN OTC DRUG 2PK 2OZ HAND SANITIIZER-ALOE VERA 2OZ HAND SANITIZER LIQUID TOPICAL 20170401 OTC MONOGRAPH NOT FINAL part333A Ningbo Liyuan Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/1 N 20181231 76176-032_60c0bc37-83a2-3280-e053-2a91aa0ae7c9 76176-032 HUMAN OTC DRUG 8OZ HAND SANITIZER WITH PUMP 8OZ HAND SANITIZER GEL TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part333A Ningbo Liyuan Daily Chemical Products Co., Ltd. ALCOHOL 70 mL/1 N 20181231 76176-034_605dac00-9069-6c5e-e053-2991aa0a2c81 76176-034 HUMAN OTC DRUG QC 2OZ INSTANT HAND SANITIZER (ORIGINAL) ALCOHOL GEL TOPICAL 20171009 OTC MONOGRAPH NOT FINAL part333A Ningbo Liyuan Daily Chemical Products Co., Ltd. ALCOHOL 62 mL/100mL N 20181231 76176-050_64855372-7291-7e20-e053-2a91aa0afd43 76176-050 HUMAN OTC DRUG ADRIANA CLIP ON HAND SANITIZER ALCOHOL GEL TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part333E Ningbo Liyuan Daily Chemical Products Co.,Ltd. ALCOHOL 62 mL/100mL N 20191231 76176-051_64855372-72a3-7e20-e053-2a91aa0afd43 76176-051 HUMAN OTC DRUG ADRIANA 8OZ HAND SANITIZER -ORIGINAL ALCOHOL GEL TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part333E Ningbo Liyuan Daily Chemical Products Co.,Ltd. ALCOHOL 62 mL/100mL N 20191231 76176-052_64846eb3-a011-dfb3-e053-2991aa0aebd7 76176-052 HUMAN OTC DRUG ADRIANA 8OZ HAND SANITIZER - ALOE VERA ALCOHOL GEL TOPICAL 20180131 OTC MONOGRAPH NOT FINAL part333E Ningbo Liyuan Daily Chemical Products Co.,Ltd. ALCOHOL 62 mL/100mL N 20191231 76176-202_33101c62-fa70-2c69-e054-00144ff8d46c 76176-202 HUMAN OTC DRUG Le Vital Sweet Pea ethyl alcohol GEL TOPICAL 20150723 OTC MONOGRAPH NOT FINAL part333E Ningbo Liyuan Daily Chemical Products Co., Ltd. ALCOHOL 62 g/100g N 20181231 76176-301_83c850c5-8f3e-482c-895e-a5d52f95d5f2 76176-301 HUMAN OTC DRUG MELLOW HAND SANITIZER (ALOE AND VITAMIN E) ALCOHOL GEL TOPICAL 20170616 OTC MONOGRAPH NOT FINAL part333A Ningbo Liyuan Daily Chemical Products Co.,Ltd. ALCOHOL 62 mL/100mL N 20181231 76176-302_156258ed-f67d-4e27-b051-b6db62d86053 76176-302 HUMAN OTC DRUG MELLOW HAND SANITIZER (ORIGINAL) WITH MOISTURIZER AND VITAMIN E ALCOHOL GEL TOPICAL 20170616 OTC MONOGRAPH NOT FINAL part333A Ningbo Liyuan Daily Chemical Products Co.,Ltd. ALCOHOL 62 mL/100mL N 20181231 76179-025_de6ce48a-970a-d0ab-0a84-6ed7644735f2 76179-025 PLASMA DERIVATIVE KEDBUMIN Albumin (Human) INJECTION, SOLUTION INTRAVENOUS 20110915 BLA BLA125384 Kedrion S.p.A ALBUMIN (HUMAN) 12.5 g/50mL Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient] N 20181231 76181-002_4d5a136f-e923-4cc6-b92f-1b37d096c875 76181-002 HUMAN PRESCRIPTION DRUG dextroamphetamine sulfate dextroamphetamine sulfate SOLUTION ORAL 20140106 ANDA ANDA040776 Avadel Generics, LLC DEXTROAMPHETAMINE SULFATE 5 mg/5mL Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] CII N 20181231 76182-001_b3167729-0d12-4cfc-a8e2-9fb66ed7f287 76182-001 HUMAN OTC DRUG HUA TUO XIAN GAO CLOTRIMAZOLE OINTMENT TOPICAL 20110428 OTC MONOGRAPH FINAL part333C SHANGHAI SONGHUA PHARMACEUTICAL CO LTD CLOTRIMAZOLE 1 mg/100g N 20181231 76184-0100_aca2aab0-a625-4f2a-87d7-6d29fb53a4b8 76184-0100 HUMAN OTC DRUG DERMASIL ADVANCED DIMETHICONE LOTION TOPICAL 20170830 OTC MONOGRAPH FINAL part347 Fantasia Beauty LLC DIMETHICONE .01 g/mL N 20181231 76184-0101_2272a180-8aa3-4b29-b9c2-4529749b9041 76184-0101 HUMAN OTC DRUG DERMASIL DRYSKIN DIMETHICONE LOTION TOPICAL 20170830 OTC MONOGRAPH FINAL part347 Fantasia Beauty LLC DIMETHICONE .01 g/mL N 20181231 76184-0102_b33c2aab-53d5-44d7-b2ec-3ab8d314a370 76184-0102 HUMAN OTC DRUG DERMASIL SENSITIVE DIMETHICONE LOTION TOPICAL 20170830 OTC MONOGRAPH FINAL part347 Fantasia Beauty LLC DIMETHICONE .01 g/mL N 20181231 76184-1001_c5e69c83-8db5-4c95-8b84-0694e6da94b6 76184-1001 HUMAN OTC DRUG Icing Winterberry Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151115 OTC MONOGRAPH NOT FINAL part333A Fantasia Accessories, Ltd. ALCOHOL 21 g/30mL E 20171231 76184-1002_c5e69c83-8db5-4c95-8b84-0694e6da94b6 76184-1002 HUMAN OTC DRUG Icing Peppermint Candy Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151115 OTC MONOGRAPH NOT FINAL part333A Fantasia Accessories, Ltd. ALCOHOL 21 g/30mL E 20171231 76184-1003_c5e69c83-8db5-4c95-8b84-0694e6da94b6 76184-1003 HUMAN OTC DRUG Icing Iced Frosting Anti-Bacterial Hand Sanitizer ALCOHOL GEL TOPICAL 20151115 OTC MONOGRAPH NOT FINAL part333A Fantasia Accessories, Ltd. ALCOHOL 21 g/30mL E 20171231 76187-762_60ef9abf-5836-08cc-e053-2991aa0ae668 76187-762 HUMAN OTC DRUG Ageless Pain Relief METHYL SALICYLATE, MENTHOL CREAM TOPICAL 20110423 OTC MONOGRAPH NOT FINAL part348 Isagenix International, LLC METHYL SALICYLATE; MENTHOL 140; 70 mg/mL; mg/mL N 20191231 76187-850_60ef952f-30a5-5bbe-e053-2a91aa0adc10 76187-850 HUMAN OTC DRUG Isa SunGuard SPF 30 ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20110526 OTC MONOGRAPH FINAL part352 Isagenix International, LLC ZINC OXIDE; TITANIUM DIOXIDE 60; 23 mg/mL; mg/mL N 20191231 76187-860_60ef9d05-5599-6441-e053-2a91aa0ae023 76187-860 HUMAN OTC DRUG Rejuvity moisturizing day cream BROAD SPECTRUM SPF 15 SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20130523 OTC MONOGRAPH NOT FINAL part352 Isagenix International, LLC TITANIUM DIOXIDE; ZINC OXIDE 10; 65 mg/mL; mg/mL N 20181231 76189-113_d485ee73-d30f-4a14-ae43-474317f1643e 76189-113 HUMAN PRESCRIPTION DRUG Alunbrig Brigatinib TABLET, COATED ORAL 20170428 NDA NDA208772 ARIAD Pharmaceuticals Inc. BRIGATINIB 30 mg/1 Kinase Inhibitor [EPC],Tyrosine Kinase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA] N 20181231 76189-533_4d5f7837-cb1f-4f2c-8788-0f9b594fb748 76189-533 HUMAN PRESCRIPTION DRUG Iclusig ponatinib hydrochloride TABLET, FILM COATED ORAL 20150422 NDA NDA203469 ARIAD Pharmaceuticals, Inc. PONATINIB HYDROCHLORIDE 30 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 76189-534_4d5f7837-cb1f-4f2c-8788-0f9b594fb748 76189-534 HUMAN PRESCRIPTION DRUG Iclusig ponatinib hydrochloride TABLET, FILM COATED ORAL 20121214 NDA NDA203469 ARIAD Pharmaceuticals, Inc. PONATINIB HYDROCHLORIDE 45 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 76189-535_4d5f7837-cb1f-4f2c-8788-0f9b594fb748 76189-535 HUMAN PRESCRIPTION DRUG Iclusig ponatinib hydrochloride TABLET, FILM COATED ORAL 20121214 NDA NDA203469 ARIAD Pharmaceuticals, Inc. PONATINIB HYDROCHLORIDE 15 mg/1 Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] N 20181231 76204-002_f54c79f2-308f-4c04-8a6f-186fbc90bb8c 76204-002 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20121201 NDA AUTHORIZED GENERIC NDA020837 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 76204-003_f54c79f2-308f-4c04-8a6f-186fbc90bb8c 76204-003 HUMAN PRESCRIPTION DRUG Levalbuterol Hydrochloride Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20121201 NDA AUTHORIZED GENERIC NDA020837 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 76204-100_757ca397-242f-4db3-b7e3-474160446cf3 76204-100 HUMAN PRESCRIPTION DRUG Ipratropium Bromide Ipratropium Bromide SOLUTION RESPIRATORY (INHALATION) 20110201 ANDA ANDA075693 Ritedose Pharmaceuticals, LLC IPRATROPIUM BROMIDE .5 mg/2.5mL Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 76204-200_5fb07c03-37b0-5192-e053-2a91aa0a4775 76204-200 HUMAN PRESCRIPTION DRUG Albuterol Sulfate Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20111205 ANDA ANDA077839 Ritedose Pharmaceuticals, LLC ALBUTEROL SULFATE 2.5 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 76204-600_5fb18294-5eaf-ca69-e053-2991aa0a3e1d 76204-600 HUMAN PRESCRIPTION DRUG IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE Ipratropium Bromide and Albuterol Sulfate SOLUTION RESPIRATORY (INHALATION) 20121015 ANDA ANDA202496 Ritedose Pharmaceuticals, LLC ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 2.5; .5 mg/3mL; mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 76204-700_603f8a62-ce1b-1d78-e053-2a91aa0a42c5 76204-700 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20160322 ANDA ANDA203653 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 76204-800_603f8a62-ce1b-1d78-e053-2a91aa0a42c5 76204-800 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20160322 ANDA ANDA203653 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 76204-900_603f8a62-ce1b-1d78-e053-2a91aa0a42c5 76204-900 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20160322 ANDA ANDA203653 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC] N 20181231 76206-001_533bb57a-b5dc-4527-a92a-6644617e265d 76206-001 HUMAN OTC DRUG COUGH BE GONE Dextromethorphan Hydrobromide Guaifenesin LIQUID ORAL 20140130 OTC MONOGRAPH FINAL part341 RFX Pharmaceutical Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 76206-002_ae0d530f-6f9a-4fdd-81c9-d7e42d421cc1 76206-002 HUMAN OTC DRUG COUGH MEDICINE soothing relief Dextromethorphan LIQUID ORAL 20140130 OTC MONOGRAPH FINAL part341 RFX Pharmaceutical Co., Ltd. DEXTROMETHORPHAN HYDROBROMIDE 30 mg/10mL E 20171231 76206-301_aea20842-cf51-4167-bcf8-9575572654bb 76206-301 HUMAN OTC DRUG Lao Wei Wood Lock Oil Methyl Salicylate, Menthol OIL TOPICAL 20140615 OTC MONOGRAPH NOT FINAL part348 RFX Pharmaceutical Co Ltd METHYL SALICYLATE; MENTHOL 5; 16 g/100mL; g/100mL E 20171231 76209-123_60efcfbb-bb32-24b9-e053-2a91aa0a9645 76209-123 HUMAN OTC DRUG Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50 Plus HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM TOPICAL 20110503 OTC MONOGRAPH NOT FINAL part352 Market America HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE 100; 50; 30; 26 mg/mL; mg/mL; mg/mL; mg/mL N 20181231 76209-234_60eff1e9-f405-1fc4-e053-2991aa0abdf0 76209-234 HUMAN OTC DRUG De-Aging Moisturizing Day Creme With Sunscreen SPF 20 OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20110608 OTC MONOGRAPH FINAL part352 Market America OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE 75; 30; 30; 4 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 76214-001_b0ca328d-8f2d-4199-b45b-aa00c98fb956 76214-001 HUMAN OTC DRUG GOLD CAVIAR COLLAGEN SERUM FOR COSMECEUTICAL FOR WRINKLE CARE DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 1.8 mL/45mL N 20181231 76214-002_96fb05a2-9b64-4dc3-88c5-bfe2367980d0 76214-002 HUMAN OTC DRUG GOLDKIWI DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 3.69 g/55g N 20181231 76214-003_8d38537b-055d-47fb-8b5f-87570120411c 76214-003 HUMAN OTC DRUG AGAVE CACTUS SERUM DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .45 mL/45mL N 20181231 76214-004_5dedd490-d283-41f5-affc-840ff01ff889 76214-004 HUMAN OTC DRUG AGAVE CACTUS LIGHT DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .45 g/45g N 20181231 76214-005_698e7d93-c8a4-449c-964c-089f141a9c72 76214-005 HUMAN OTC DRUG TOMATO WHITENING SERUM DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .35 mL/35mL N 20181231 76214-006_51f56b56-9824-4309-ae05-76ef163267e5 76214-006 HUMAN OTC DRUG AGAVE CACTUS HYDRATING DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .9 g/45g N 20181231 76214-007_d8cbfe3f-0d83-436b-8995-e00bde49aac7 76214-007 HUMAN OTC DRUG OMIJA WHITENING DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 2 g/50g N 20181231 76214-008_765773c1-b9b9-45d0-afb4-09329e0797df 76214-008 HUMAN OTC DRUG PLATINUM GRAPE CELL EMULSION DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 1.8 mL/130mL N 20181231 76214-009_3a568818-3564-4540-8bb4-1e074db8feb0 76214-009 HUMAN OTC DRUG LEMON GINGER TEA DEODORANT ALUMINUM CHLOROHYDRATE SPRAY CUTANEOUS 20110301 OTC MONOGRAPH FINAL part350 SKINFOOD CO., LTD. ALUMINUM CHLOROHYDRATE 3 mL/100mL N 20181231 76214-010_4b26437a-7999-4ae7-99a7-5bbbc01e6300 76214-010 HUMAN OTC DRUG GOLD CAVIAR SERUM DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 3.51 mL/45mL N 20181231 76214-011_e833d5ab-51bd-4d3a-9661-2bbb5406f915 76214-011 HUMAN OTC DRUG ANCIENT RICE SERUM DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .51 mL/50mL N 20181231 76214-012_6209c189-d628-4727-8aac-a565a7424afb 76214-012 HUMAN OTC DRUG PEACH SAKE SUN SPF32 PA Plus Plus OCTINOXATE LOTION CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 5.25; 2.47 mL/75mL; mL/75mL N 20181231 76214-013_0dff75e2-4230-4392-ac26-8b16abcaeaa9 76214-013 HUMAN OTC DRUG GOLDKIWI SUN SPF50 Plus PA Plus Plus OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 3.75; 2.45; 1.45 g/50g; g/50g; g/50g N 20181231 76214-014_1413e5f0-f500-4104-b733-9512050efe31 76214-014 HUMAN OTC DRUG CARROT SUN SPF30 PA Plus Plus OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; AVOBENZONE 3; 2.5; 1.7; .75 g/50g; g/50g; g/50g; g/50g N 20181231 76214-015_783fcb21-2ce4-4843-bff3-52a4b600a6ed 76214-015 HUMAN OTC DRUG YAM DOUBLE CARE FLUID SPF17 PA Plus Plus OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; AVOBENZONE; ENSULIZOLE 5.6; 2.1; 1.4 mL/140mL; mL/140mL; mL/140mL N 20181231 76214-016_f16d6eda-1d77-4497-92a4-8fbdde3d1558 76214-016 HUMAN OTC DRUG PEACH SAKE PORE BB SPF20 PA Plus Number2 Natural Beige TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 2.32; .9 mL/30mL; mL/30mL N 20181231 76214-017_27141064-de15-4df1-8e62-5f706f46bd8d 76214-017 HUMAN OTC DRUG PEACH SAKE PORE BB SPF20 PA Plus Number1 Light Beige TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 2.32; .9 mL/30mL; mL/30mL N 20181231 76214-018_3d60ff48-3b2a-4ead-9122-980f52a42be1 76214-018 HUMAN OTC DRUG BROCCOLI SUN SPF42 PA PLUS PLUS PLUS OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 2.5; 2.5; 1.9; 1.44 mL/50mL; mL/50mL; mL/50mL; mL/50mL N 20181231 76214-019_cb4b69e6-01fe-4955-a69c-16ff4169822c 76214-019 HUMAN OTC DRUG ALOE SUN SPF28 PA PLUS PLUS OCTINOXATE SPRAY CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; ENSULIZOLE 7; 2 mL/100mL; mL/100mL N 20181231 76214-020_19a60948-95ea-47d6-9dd6-59f466310504 76214-020 HUMAN OTC DRUG WHITENING MILK AND GREEN TEA SERUM FOR MEN DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .35 mL/35mL N 20181231 76214-021_144835d7-0fee-4568-acfb-be5f8052fbbd 76214-021 HUMAN OTC DRUG FERMENTED SOY MILK WRINKLE CARE SLEEPING MASK DIMETHICONE PATCH CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 4 g/100g N 20181231 76214-022_6b4bd020-e7c3-47c6-ab29-a084d0670a47 76214-022 HUMAN OTC DRUG FERMENTED POMEGRANTE WHITENING SLEEPING MASK DIMETHICONE PATCH CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 4 g/100g N 20181231 76214-023_6dd3ec2f-f08d-44ba-a515-730cfd100d21 76214-023 HUMAN OTC DRUG FRESH JUICE C WHITENING CARE DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE .5 g/50g N 20181231 76214-024_ccf3634f-6479-4cf0-8a6e-67686c586b43 76214-024 HUMAN OTC DRUG FRESH JUICE E SERUM WRINKLE CARE DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 2.65 mL/50mL N 20181231 76214-025_e064fb1b-2a12-463b-9308-d3c7238d8652 76214-025 HUMAN OTC DRUG FRESH JUICE E WRINKLE CARE DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 2.25 g/50g N 20181231 76214-026_20289cb9-2840-4bc3-af59-b1521eb6e216 76214-026 HUMAN OTC DRUG BETULA ALBA JUICE WHITE GEL FOR MEN DIMETHICONE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. DIMETHICONE 2.72 g/50g N 20181231 76214-027_273ed941-47b6-4a11-98c9-ecc2a5f7bbba 76214-027 HUMAN OTC DRUG ALOE SUN BB SPF20 PA PLUS NUMBER1 RADIANT SKIN TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 3.86; 1.5 g/50g; g/50g N 20181231 76214-028_3bed856d-ed90-4ba5-be88-42bd5478f70d 76214-028 HUMAN OTC DRUG ALOE SUN BB SPF20 PA PLUS NUMBER1 NATURAL SKIN TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE; OCTINOXATE 3.86; 1.5 g/50g; g/50g N 20181231 76214-029_11caa614-8cf5-4bba-818e-0c210f3f93f4 76214-029 HUMAN OTC DRUG TOMATO WRINKLE SUN SPF36 PA PLUS PLUS OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 2.05; 1.43 mL/50mL; mL/50mL; mL/50mL N 20181231 76214-030_f4bd8668-f3a0-4e83-a124-bc272714dee9 76214-030 HUMAN OTC DRUG ALOE SUN ESSENCE SPF 27 PA PLUS PLUS OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 3.5; 1.24 mL/50mL; mL/50mL N 20181231 76214-031_4c5fa4ee-7698-43ef-bc32-8f277e86ffbb 76214-031 HUMAN OTC DRUG QUINCE WHITENING SUN SPF 34 PA PLUS PLUS OCTINOXATE LOTION CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 4.9; 3.5; .65 mL/70mL; mL/70mL; mL/70mL N 20181231 76214-032_b3caa79f-5693-4ea6-abe6-524971743799 76214-032 HUMAN OTC DRUG CACTUS WHITENING SUN SPF 34 PA PLUS PLUS FOR MEN OCTINOXATE LOTION CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 4.9; 3.5; .65 mL/70mL; mL/70mL; mL/70mL N 20181231 76214-033_d93f439a-dad7-4ad4-b856-ae5382b43383 76214-033 HUMAN OTC DRUG GOAT MILK AND LAVENDER SUN FOR BABY SPF 20 PA PLUS PLUS OCTINOXATE LOTION CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; OCTISALATE 4.9; 3.15 mL/70mL; mL/70mL N 20181231 76214-034_dfb9c43e-537a-4ea3-ada2-5ac2d7cc7b23 76214-034 HUMAN OTC DRUG GOLDKIWI SUN SPF 36 PA PLUS PLUS OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.5; 2.05; 1.42 g/50g; g/50g; g/50g N 20181231 76214-035_dda70e19-38b7-499a-8f60-f4dc0652e117 76214-035 HUMAN OTC DRUG TOMATO SUN SPF 36 PA PLUS PLUS OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE 3.25; 2.12; 1.75 mL/50mL; mL/50mL; mL/50mL N 20181231 76214-036_96c5bcb8-dabe-4cdd-a92c-42bee7aedf0d 76214-036 HUMAN OTC DRUG BETULA ALBA JUICE BB SPF 30 PA PLUS PLUS FOR MEN OCTINOXATE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE 3.75; 2 g/50g; g/50g N 20181231 76214-037_97613899-2dd5-470d-9a9e-4634f385e6c4 76214-037 HUMAN OTC DRUG RED ORANGE SUN PACT SPF 50 PLUS PA PLUS PLUS PLUS OCTINOXATE POWDER CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE .66; .29; .27 g/9.5g; g/9.5g; g/9.5g N 20181231 76214-038_3cb0defc-b395-41bd-ad8a-ec355965965b 76214-038 HUMAN OTC DRUG RED ORANGE SUN SPF 45 PA PLUS PLUS PLUS TITANIUM DIOXIDE POWDER CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE; ZINC OXIDE 2.79; .59 g/20g; g/20g N 20181231 76214-039_74f19ed5-a039-49c9-9b0d-d664fcb2e20d 76214-039 HUMAN OTC DRUG GOLDKIWI SUN SPF 50 PLUS PA PLUS PLUS PLUS OCTINOXATE STICK CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. OCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE 1.47; 1.03; .87 g/21g; g/21g; g/21g N 20181231 76214-040_4fab789a-1295-4326-ad61-9b41d2241fac 76214-040 HUMAN OTC DRUG SKINFOOD CACAO HAND BALM HIGH MOIST TYPE GLYCERIN CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. GLYCERIN 19.2 g/48g N 20181231 76214-041_9b6c2df3-1a6e-4844-8751-6a04cfe2ca89 76214-041 HUMAN OTC DRUG SKINFOOD HONEY MELON HAND BALM MOIST TYPE GLYCERIN CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part347 SKINFOOD CO., LTD. GLYCERIN 16.8 g/48g N 20181231 76214-042_8b8589a9-50a1-44b6-940d-5eb9450dcda0 76214-042 HUMAN OTC DRUG RED ORANGE JELLY BB SPF20 PA PLUS PLUS NO.1 TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE 2.32 g/25g N 20181231 76214-043_7b48f300-cd09-416e-9bef-aa46ad13ae4a 76214-043 HUMAN OTC DRUG RED ORANGE JELLY BB SPF20 PA PLUS PLUS NO.2 TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE 2.32 g/25g N 20181231 76214-044_5b5187bb-b88b-4477-b32a-c086b5e93bcd 76214-044 HUMAN OTC DRUG GOOD AFTERNOON BERRY BERRY TEA BB SPF35 PA PLUS PLUS NO.1 TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.9; 1.5; .88 g/30g; g/30g; g/30g N 20181231 76214-045_86563d4d-eab9-4e6b-aa2e-3147e8ad7bc0 76214-045 HUMAN OTC DRUG GOOD AFTERNOON BERRY BERRY TEA BB SPF35 PA PLUS PLUS NO.2 TITANIUM DIOXIDE CREAM CUTANEOUS 20110301 OTC MONOGRAPH FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.9; 1.5; .88 g/30g; g/30g; g/30g N 20181231 76214-046_47b3aadf-1f53-4275-853b-9681da318602 76214-046 HUMAN OTC DRUG ALOE SUN BB SPF50 PLUS PA PLUS PLUS PLUS ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO., LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 2.7; 2.5; 2.36; 1.75 g/50g; g/50g; g/50g; g/50g N 20181231 76214-047_89a3cb88-5d41-4740-ad8e-6593481248d3 76214-047 HUMAN OTC DRUG SKINFOOD ALOE SUN BB ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO., LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 2.7; 2.5; 2.36; 1.75 g/50g; g/50g; g/50g; g/50g N 20181231 76214-048_409ae570-45a5-4ad3-82bc-f19a53e4fc16 76214-048 HUMAN OTC DRUG VITA WATER DROP CC TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO., LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.15; 2.1; .29 g/30g; g/30g; g/30g N 20181231 76214-052_b983b07e-d564-4714-a92f-62c491f80045 76214-052 HUMAN OTC DRUG SKINFOOD MIRACLE FOOD 10 SOLU TION GLYCERIN, NIACINAMIDE, ADENOSINE EMULSION TOPICAL 20160401 UNAPPROVED DRUG OTHER SKINFOOD CO.,LTD. GLYCERIN; NIACINAMIDE; ADENOSINE 7.57; 3; .06 g/150mL; g/150mL; g/150mL N 20181231 76214-053_7e4dce7c-6376-4a31-b3d9-e12c81e35b99 76214-053 HUMAN OTC DRUG SKINFOOD MIRACLE FOOD 10 SOLU TION 1ML GLYCERIN, NIACINAMIDE, ADENOSINE EMULSION TOPICAL 20160401 UNAPPROVED DRUG OTHER SKINFOOD CO.,LTD. GLYCERIN; NIACINAMIDE; ADENOSINE 50.5; 20; .4 mg/mL; mg/mL; mg/mL N 20181231 76214-054_3b7d12e4-0d80-4b27-90ae-69743bc36725 76214-054 HUMAN OTC DRUG SKINFOOD ROYAL HONEY ESSENTIAL EYE ADENOSINE CREAM TOPICAL 20160401 UNAPPROVED DRUG OTHER SKINFOOD CO.,LTD. ADENOSINE .012 g/30mL N 20181231 76214-055_b2fef5cb-1dd0-41a9-aeaa-cf67cd65d78c 76214-055 HUMAN OTC DRUG SKINFOOD REAL TEA GE L MASK CHAMOMILE Glycerin, Niacinamide, Adenosine PATCH TOPICAL 20160401 UNAPPROVED DRUG OTHER SKINFOOD CO.,LTD. GLYCERIN; NIACINAMIDE; ADENOSINE 4.5; .6; .012 g/30g; g/30g; g/30g N 20181231 76214-056_b887bbaa-4ff0-4f6d-af46-494d57af606c 76214-056 HUMAN OTC DRUG SKINFOOD REAL TEA GE L MASK LAVENDER Glycerin, Niacinamide, Adenosine PATCH TOPICAL 20160401 UNAPPROVED DRUG OTHER SKINFOOD CO.,LTD. GLYCERIN; NIACINAMIDE; ADENOSINE 4.5; .6; .012 g/30g; g/30g; g/30g N 20181231 76214-057_a7f7e831-c953-4f2c-b8b9-d3d7da9e466b 76214-057 HUMAN OTC DRUG SKINFOOD REAL TEA GE L MASK ROSE Glycerin, Niacinamide, Adenosine PATCH TOPICAL 20160401 UNAPPROVED DRUG OTHER SKINFOOD CO.,LTD. GLYCERIN; NIACINAMIDE; ADENOSINE 4.5; .6; .012 g/30g; g/30g; g/30g N 20181231 76214-058_23ea491f-c6d0-4d21-a7a6-430b78215890 76214-058 HUMAN OTC DRUG SKINFOOD GOLD CAVIAR COLLAGEN SERUM ADENOSINE CREAM TOPICAL 20110301 UNAPPROVED DRUG OTHER SKINFOOD CO.,LTD. ADENOSINE .018 g/45mL N 20181231 76214-059_db48a7bd-ce58-4c35-9b0a-8b453dd57235 76214-059 HUMAN OTC DRUG SKINFOOD GOLD CAVIAR SERUM ADENOSINE CREAM TOPICAL 20110301 UNAPPROVED DRUG OTHER SKINFOOD CO.,LTD. ADENOSINE .018 g/45mL N 20181231 76214-060_e1db7b08-2388-4c7e-abef-f03923cb427c 76214-060 HUMAN OTC DRUG SKINFOOD ROYAL HONEY ESSENTIAL EYE INDIVIDUAL SAMPLE ADENOSINE CREAM TOPICAL 20160401 UNAPPROVED DRUG OTHER SKINFOOD CO.,LTD. ADENOSINE .4 mg/g N 20181231 76214-062_7b40721a-ebbb-4ad9-b93f-8155e767a0f3 76214-062 HUMAN OTC DRUG SKINFOOD ROYAL HONEY GOOD SUN OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE GEL TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO.,LTD. OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.5; 2.5; .4 g/50mL; g/50mL; g/50mL N 20181231 76214-063_c9b2a0fa-58f1-4fc6-9324-94c7e68cd78c 76214-063 HUMAN OTC DRUG SKINFOOD MIRACLE FOOD 10 SOLU TION SUN ESSENCE OCTINOXATE, OCTISALATE, ENSULIZOLE, TITANIUM DIOXIDE, ZINC OXIDE, AVOBENZONE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO.,LTD. OCTINOXATE; OCTISALATE; ENSULIZOLE; TITANIUM DIOXIDE; ZINC OXIDE; AVOBENZONE 3.5; 2.5; 1.5; .7; .7; .6 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL N 20181231 76214-064_225b00e3-aae0-44bf-81e5-2733d0bd5278 76214-064 HUMAN OTC DRUG SKINFOOD VITA WATER DROP CC TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 2.1; 2.1; .3 g/30g; g/30g; g/30g N 20181231 76214-065_8c448026-72c7-4a6b-aff9-0a21b3e58f3e 76214-065 HUMAN OTC DRUG SKINFOOD ALOE WATERY SUN WATERPROOF ZINC OXIDE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO.,LTD. ZINC OXIDE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 6.4; 3.5; 2.2; .8 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 76214-066_702ca450-50ee-42f1-8f1d-4975d85b04b4 76214-066 HUMAN OTC DRUG SKINFOOD ALOE SUN BB 01 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE 3.8; 1.5 g/50g; g/50g N 20181231 76214-067_a9bf6884-d780-4c95-b452-710bbbd28077 76214-067 HUMAN OTC DRUG SKINFOOD ALOE SUN BB 02 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20160801 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE 3.8; 1.5 g/50g; g/50g N 20181231 76214-068_43ee624b-6c00-41a7-a8e5-e90bca77e425 76214-068 HUMAN OTC DRUG SKINFOOD ALOE SUN BB 02 Natural Skin ZINC OXIDE, OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE CREAM TOPICAL 20160715 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO.,LTD. ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE 2.7; 2.5; 2.3; 1.7 g/50g; g/50g; g/50g; g/50g N 20181231 76214-069_b89a1063-c5bf-4770-86a9-2b2ab9ae2015 76214-069 HUMAN OTC DRUG SKINFOOD PEACH SAKE PORE BB 01 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20160715 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE 2.3; .9 g/30mL; g/30mL N 20181231 76214-070_b79c84c6-5076-48ec-b369-20dfeb0a4bdb 76214-070 HUMAN OTC DRUG SKINFOOD PEACH SAKE PORE BB 02 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20160715 OTC MONOGRAPH NOT FINAL part352 SKINFOOD CO.,LTD. TITANIUM DIOXIDE; OCTINOXATE 2.3; .9 g/30mL; g/30mL N 20181231 76224-101_08b50aa0-79e9-4d93-a3bc-bf61410f21d4 76224-101 HUMAN OTC DRUG SPF 15 Self Tanner OCTINOXATE,OXYBENZONE LOTION TOPICAL 20110525 OTC MONOGRAPH NOT FINAL part352 Whish Body Holdings Inc OCTINOXATE; OXYBENZONE 7.5; 5 mL/100mL; mL/100mL E 20171231 76229-123_60ef952f-30c4-5bbe-e053-2a91aa0adc10 76229-123 HUMAN OTC DRUG Likewise Hand Moisturizer - Sun Protectant SPF 50 OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20110620 OTC MONOGRAPH FINAL part352 Likewise Incorporated OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 111.6 mg/mL; mg/mL; mg/mL N 20191231 76229-234_60ef9bf0-edfd-643f-e053-2a91aa0a21f9 76229-234 HUMAN OTC DRUG Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily Skin TITANIUM DIOXIDE, ZINC OXIDE CREAM TOPICAL 20110620 OTC MONOGRAPH FINAL part352 Likewise Incorporated TITANIUM DIOXIDE; ZINC OXIDE 65; 66.5 mg/mL; mg/mL N 20191231 76229-345_6191d2ea-653a-e9f0-e053-2991aa0a5fa1 76229-345 HUMAN OTC DRUG Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Oily Skin OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20110620 OTC MONOGRAPH FINAL part352 Likewise Incorporated OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 111.6 mg/mL; mg/mL; mg/mL N 20191231 76229-456_60eec70e-ccf8-31fa-e053-2a91aa0a28a1 76229-456 HUMAN OTC DRUG Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Dry Skin OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20110514 OTC MONOGRAPH FINAL part352 Likewise Incorporated OCTINOXATE; OCTISALATE; ZINC OXIDE 75; 50; 111.6 mg/mL; mg/mL; mg/mL N 20191231 76230-727_60eece35-76fa-4cf2-e053-2991aa0af6a8 76230-727 HUMAN OTC DRUG Everyday Facial Moisturizer And Sunscreen SPF 20 ZINC OXIDE CREAM TOPICAL 20110609 OTC MONOGRAPH FINAL part352 714 Essentials LTD ZINC OXIDE 163.2 mg/mL N 20191231 76234-000_c5b3af32-3502-4828-8de2-cccb3f2a3994 76234-000 HUMAN PRESCRIPTION DRUG Aceon perindopril erbumine TABLET ORAL 19931230 NDA NDA020184 XOMA (US) LLC PERINDOPRIL ERBUMINE 2 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 76234-001_c5b3af32-3502-4828-8de2-cccb3f2a3994 76234-001 HUMAN PRESCRIPTION DRUG Aceon perindopril erbumine TABLET ORAL 19931230 NDA NDA020184 XOMA (US) LLC PERINDOPRIL ERBUMINE 4 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 76234-002_c5b3af32-3502-4828-8de2-cccb3f2a3994 76234-002 HUMAN PRESCRIPTION DRUG Aceon perindopril erbumine TABLET ORAL 19931230 NDA NDA020184 XOMA (US) LLC PERINDOPRIL ERBUMINE 8 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 76237-100_a205f605-59ea-4348-8587-93b538e41302 76237-100 HUMAN OTC DRUG Mapap ACETAMINOPHEN TABLET ORAL 20110829 UNAPPROVED DRUG OTHER McKesson Contract Packaging ACETAMINOPHEN 325 mg/1 E 20171231 76237-101_573be06c-e271-4443-b727-5e4506fa28e5 76237-101 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN CAPSULE ORAL 20111004 UNAPPROVED HOMEOPATHIC McKesson Contract Packaging ACETAMINOPHEN 500 mg/1 E 20171231 76237-102_3808efbf-a81b-4ce2-8db0-56fa676d736b 76237-102 HUMAN OTC DRUG Extra Strength Mapap ACETAMINOPHEN TABLET ORAL 20111220 UNAPPROVED DRUG OTHER McKesson Contract Packaging ACETAMINOPHEN 500 mg/1 E 20171231 76237-103_79fb3828-3b00-4b01-a135-b3ca456168ed 76237-103 HUMAN PRESCRIPTION DRUG Acetaminophen and Codeine Phosphate Acetaminophen and Codeine Phosphate TABLET ORAL 20111021 ANDA ANDA088628 McKesson Contract Packaging ACETAMINOPHEN; CODEINE PHOSPHATE 300; 30 mg/1; mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIII E 20171231 76237-104_c58b2502-67fa-4535-97a0-4c6b4043a38f 76237-104 HUMAN PRESCRIPTION DRUG Allopurinol Allopurinol TABLET ORAL 20111216 ANDA ANDA018659 McKesson Contract Packaging ALLOPURINOL 100 mg/1 Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA] E 20171231 76237-105_a0bc8740-7a93-444d-9d6e-d40faa1d58cc 76237-105 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20111024 ANDA ANDA074342 McKesson Contract Packaging ALPRAZOLAM .25 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-106_a0bc8740-7a93-444d-9d6e-d40faa1d58cc 76237-106 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20111017 ANDA ANDA074342 McKesson Contract Packaging ALPRAZOLAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-107_a0bc8740-7a93-444d-9d6e-d40faa1d58cc 76237-107 HUMAN PRESCRIPTION DRUG Alprazolam Alprazolam TABLET ORAL 20111017 ANDA ANDA074342 McKesson Contract Packaging ALPRAZOLAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-108_48f8c54d-0d7e-4469-86ca-93221d6c8f7d 76237-108 HUMAN PRESCRIPTION DRUG Amiodarone Hydrochloride Amiodarone Hydrochloride TABLET ORAL 20120103 ANDA ANDA075315 McKesson Contract Packaging AMIODARONE HYDROCHLORIDE 200 mg/1 Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] E 20171231 76237-109_48072673-1f7f-4fa8-aebb-00b4dba4a0ae 76237-109 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20110914 ANDA ANDA076418 McKesson Contract Packaging AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 76237-110_48072673-1f7f-4fa8-aebb-00b4dba4a0ae 76237-110 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20110914 ANDA ANDA076418 McKesson Contract Packaging AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 76237-111_48072673-1f7f-4fa8-aebb-00b4dba4a0ae 76237-111 HUMAN PRESCRIPTION DRUG Amlodipine Besylate amlodipine besylate TABLET ORAL 20110914 ANDA ANDA076418 McKesson Contract Packaging AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] E 20171231 76237-112_5f410e51-c1a4-4b1b-8d18-fef788bb5c04 76237-112 HUMAN OTC DRUG Micro-Coated Aspirin Micro-Coated Aspirin TABLET ORAL 20110930 UNAPPROVED DRUG OTHER McKesson Contract Packaging ASPIRIN 325 mg/1 E 20171231 76237-113_20e6238d-9c29-494a-82ab-ea45736dda07 76237-113 HUMAN OTC DRUG aspirin Aspirin TABLET, CHEWABLE ORAL 20111117 UNAPPROVED MEDICAL GAS McKesson Contract Packaging ASPIRIN 81 mg/1 E 20171231 76237-115_865ea555-ba24-4f2c-8791-cf681b76ad3f 76237-115 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 20111003 ANDA ANDA074052 McKesson Contract Packaging ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 76237-116_cad3d03b-4e1b-434f-90f1-cca2789e96ab 76237-116 HUMAN PRESCRIPTION DRUG Atenolol atenolol TABLET ORAL 20111228 ANDA ANDA073457 McKesson Contract Packaging ATENOLOL 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 76237-117_6dee51a6-9a37-4cb2-9266-b8a698402aa2 76237-117 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20111114 ANDA ANDA072234 McKesson Contract Packaging BACLOFEN 10 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 76237-118_6dee51a6-9a37-4cb2-9266-b8a698402aa2 76237-118 HUMAN PRESCRIPTION DRUG Baclofen Baclofen TABLET ORAL 20111212 ANDA ANDA072235 McKesson Contract Packaging BACLOFEN 20 mg/1 GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] E 20171231 76237-120_4e15d6e7-7f85-44a0-8169-aa1312a32f37 76237-120 HUMAN PRESCRIPTION DRUG Benztropine Mesylate Benztropine Mesylate TABLET ORAL 20111208 ANDA ANDA089059 McKesson Contract Packaging BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 76237-121_aca8b358-d172-43d6-95bb-8064b8ed680c 76237-121 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20111107 ANDA ANDA075022 McKesson Contract Packaging BUSPIRONE HYDROCHLORIDE 5 mg/1 E 20171231 76237-122_aca8b358-d172-43d6-95bb-8064b8ed680c 76237-122 HUMAN PRESCRIPTION DRUG Buspirone Hydrochloride Buspirone Hydrochloride TABLET ORAL 20111121 ANDA ANDA075022 McKesson Contract Packaging BUSPIRONE HYDROCHLORIDE 10 mg/1 E 20171231 76237-126_a3f9a1e3-133e-4a97-be1e-d92deef34ddc 76237-126 HUMAN PRESCRIPTION DRUG Carbamazepine Carbamazepine TABLET ORAL 20111007 ANDA ANDA070541 McKesson Contract Packaging CARBAMAZEPINE 200 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 76237-127_6fca30bd-28e5-4e32-b194-97c84966900d 76237-127 HUMAN PRESCRIPTION DRUG CARBAMAZEPINE CARBAMAZEPINE TABLET, CHEWABLE ORAL 20110901 ANDA ANDA075712 McKesson Contract Packaging CARBAMAZEPINE 100 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA] E 20171231 76237-129_d17e17d5-f73a-49c5-b1bd-2543cc486edf 76237-129 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20111011 ANDA ANDA074260 McKesson Contract Packaging CARBIDOPA; LEVODOPA 25; 100 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 76237-130_d17e17d5-f73a-49c5-b1bd-2543cc486edf 76237-130 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa Carbidopa and Levodopa TABLET ORAL 20111221 ANDA ANDA074260 McKesson Contract Packaging CARBIDOPA; LEVODOPA 25; 250 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 76237-131_577b23c1-bd6d-41a4-a7c5-ebe7b92e37bd 76237-131 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20110920 ANDA ANDA078227 McKesson Contract Packaging CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 76237-132_577b23c1-bd6d-41a4-a7c5-ebe7b92e37bd 76237-132 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20110922 ANDA ANDA078227 McKesson Contract Packaging CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 76237-133_577b23c1-bd6d-41a4-a7c5-ebe7b92e37bd 76237-133 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20110921 ANDA ANDA078227 McKesson Contract Packaging CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 76237-134_577b23c1-bd6d-41a4-a7c5-ebe7b92e37bd 76237-134 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20110921 ANDA ANDA078227 McKesson Contract Packaging CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] E 20171231 76237-135_9ce0e304-583e-4850-ba40-c3534cf1b068 76237-135 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110922 ANDA ANDA077048 McKesson Contract Packaging CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 76237-136_9ce0e304-583e-4850-ba40-c3534cf1b068 76237-136 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110901 ANDA ANDA077048 McKesson Contract Packaging CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 76237-137_9ce0e304-583e-4850-ba40-c3534cf1b068 76237-137 HUMAN PRESCRIPTION DRUG Citalopram Citalopram TABLET ORAL 20110922 ANDA ANDA077048 McKesson Contract Packaging CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 76237-138_5da72d49-de2b-4e23-bb78-9eb4d98b8974 76237-138 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20111011 ANDA ANDA074869 McKesson Contract Packaging CLONAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-139_5da72d49-de2b-4e23-bb78-9eb4d98b8974 76237-139 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20111012 ANDA ANDA074869 McKesson Contract Packaging CLONAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-140_5da72d49-de2b-4e23-bb78-9eb4d98b8974 76237-140 HUMAN PRESCRIPTION DRUG Clonazepam Clonazepam TABLET ORAL 20111018 ANDA ANDA074869 McKesson Contract Packaging CLONAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-141_835bb6d3-6437-499d-85e5-e012f17d356c 76237-141 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20120110 ANDA ANDA070974 McKesson Contract Packaging CLONIDINE HYDROCHLORIDE .1 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 76237-142_835bb6d3-6437-499d-85e5-e012f17d356c 76237-142 HUMAN PRESCRIPTION DRUG Clonidine Hydrochloride Clonidine Hydrochloride TABLET ORAL 20111003 ANDA ANDA070975 McKesson Contract Packaging CLONIDINE HYDROCHLORIDE .2 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 76237-143_19567e4e-2afe-41e7-b8d1-956843b75687 76237-143 HUMAN PRESCRIPTION DRUG Cyclobenzaprine Hydrochloride cyclobenzaprine hydrochloride TABLET, FILM COATED ORAL 20110929 ANDA ANDA077797 McKesson Contract Packaging CYCLOBENZAPRINE HYDROCHLORIDE 10 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 76237-144_facbab47-582b-4ad6-b18f-8ecf1d4bc8fb 76237-144 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20111013 ANDA ANDA071321 McKesson Contract Packaging DIAZEPAM 5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-145_facbab47-582b-4ad6-b18f-8ecf1d4bc8fb 76237-145 HUMAN PRESCRIPTION DRUG Diazepam Diazepam TABLET ORAL 20091109 ANDA ANDA071322 McKesson Contract Packaging DIAZEPAM 10 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-146_6873ef01-b305-4a94-89ff-89d93298920c 76237-146 HUMAN PRESCRIPTION DRUG Digoxin Digoxin TABLET ORAL 20111011 ANDA ANDA077002 McKesson Contract Packaging DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 76237-147_2ff06b26-430d-4710-99ee-1f060079cc58 76237-147 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20111104 ANDA ANDA072838 McKesson Contract Packaging DILTIAZEM HYDROCHLORIDE 30 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 76237-148_2ff06b26-430d-4710-99ee-1f060079cc58 76237-148 HUMAN PRESCRIPTION DRUG Diltiazem Hydrochloride diltiazem hydrochloride TABLET, FILM COATED ORAL 20110922 ANDA ANDA072838 McKesson Contract Packaging DILTIAZEM HYDROCHLORIDE 60 mg/1 Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC] E 20171231 76237-149_127adef8-5b73-4217-899c-31fbd95c6bdf 76237-149 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 20111107 ANDA ANDA085762 McKesson Contract Packaging DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE 2.5; .025 mg/1; mg/1 Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] CV E 20171231 76237-150_54f6e14f-7c38-4c4f-85fc-cf5b25589ba9 76237-150 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110103 ANDA ANDA078182 McKesson Contract Packaging DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 76237-151_54f6e14f-7c38-4c4f-85fc-cf5b25589ba9 76237-151 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20111017 ANDA ANDA078182 McKesson Contract Packaging DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 76237-152_54f6e14f-7c38-4c4f-85fc-cf5b25589ba9 76237-152 HUMAN PRESCRIPTION DRUG Divalproex Sodium Divalproex Sodium TABLET, DELAYED RELEASE ORAL 20110829 ANDA ANDA078182 McKesson Contract Packaging DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 76237-153_cf18a4c9-ba0b-4ac3-88b8-cc5889b0898f 76237-153 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120223 ANDA ANDA077567 McKesson Contract Packaging DIVALPROEX SODIUM 250 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 76237-154_cf18a4c9-ba0b-4ac3-88b8-cc5889b0898f 76237-154 HUMAN PRESCRIPTION DRUG Divalproex Sodium divalproex sodium TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111014 ANDA ANDA077567 McKesson Contract Packaging DIVALPROEX SODIUM 500 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 76237-155_c41abc6d-1918-4b35-80cc-2b3c019822d6 76237-155 HUMAN PRESCRIPTION DRUG Divalproex sodium Divalproex sodium CAPSULE ORAL 20111214 ANDA ANDA078979 McKesson Contract Packaging DIVALPROEX SODIUM 125 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 76237-157_a6355634-dab6-4995-b608-898988d14ad9 76237-157 HUMAN PRESCRIPTION DRUG Famotidine Famotidine TABLET, FILM COATED ORAL 20111025 ANDA ANDA075511 McKesson Contract Packaging FAMOTIDINE 20 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 76237-159_28d1233a-12b6-4b24-9ab6-079b005826ae 76237-159 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20111017 ANDA ANDA076001 McKesson Contract Packaging FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 76237-160_7bdfb785-2462-4b8e-bdaf-508f9b464526 76237-160 HUMAN PRESCRIPTION DRUG folic acid folic acid TABLET ORAL 20120305 ANDA ANDA080600 McKesson Contract Packaging FOLIC ACID 1 mg/1 E 20171231 76237-161_ede2dd16-2ab8-40c3-b490-8cc760c8278e 76237-161 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20111007 ANDA ANDA018413 McKesson Contract Packaging FUROSEMIDE 20 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 76237-162_ede2dd16-2ab8-40c3-b490-8cc760c8278e 76237-162 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20111011 ANDA ANDA018413 McKesson Contract Packaging FUROSEMIDE 40 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 76237-163_3a2c0f3a-7cdb-49b2-9215-e8efcc66e05f 76237-163 HUMAN PRESCRIPTION DRUG Furosemide Furosemide TABLET ORAL 20110829 ANDA ANDA018569 McKesson Contract Packaging FUROSEMIDE 80 mg/1 Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC] E 20171231 76237-164_78edc5af-9a37-45f7-893a-414eb890f07b 76237-164 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110829 ANDA ANDA075350 McKesson Contract Packaging GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76237-165_66e3f3fd-5e5e-4db6-a32e-40a88fef42fc 76237-165 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20110829 ANDA ANDA075350 McKesson Contract Packaging GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76237-166_78edc5af-9a37-45f7-893a-414eb890f07b 76237-166 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20111209 ANDA ANDA075350 McKesson Contract Packaging GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76237-167_8a300ebc-7f47-42e7-942b-921584eada3d 76237-167 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20111109 ANDA ANDA075694 McKesson Contract Packaging GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76237-168_694abc50-a512-423f-9bf0-f8d9ac99f030 76237-168 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20110919 ANDA ANDA074256 McKesson Contract Packaging GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] E 20171231 76237-169_a82e0444-5ea7-45e6-9cde-97af77eb9a8e 76237-169 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20111003 ANDA ANDA074226 McKesson Contract Packaging GLIPIZIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 76237-170_a82e0444-5ea7-45e6-9cde-97af77eb9a8e 76237-170 HUMAN PRESCRIPTION DRUG Glipizide glipizide TABLET ORAL 20111122 ANDA ANDA074226 McKesson Contract Packaging GLIPIZIDE 10 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 76237-171_4dc7d63c-a178-4d8a-bfb8-2bfb974021a2 76237-171 HUMAN PRESCRIPTION DRUG Glyburide Glyburide TABLET ORAL 20120109 ANDA ANDA074388 McKesson Contract Packaging GLYBURIDE 5 mg/1 Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] E 20171231 76237-172_6ce41f90-e721-4141-8ea6-8c89e64099dd 76237-172 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20111202 ANDA ANDA087836 McKesson Contract Packaging HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 76237-173_6ce41f90-e721-4141-8ea6-8c89e64099dd 76237-173 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20111025 ANDA ANDA086961 McKesson Contract Packaging HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 76237-174_6ce41f90-e721-4141-8ea6-8c89e64099dd 76237-174 HUMAN PRESCRIPTION DRUG Hydralazine Hydrochloride Hydralazine Hydrochloride TABLET ORAL 20111025 ANDA ANDA086962 McKesson Contract Packaging HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] E 20171231 76237-175_7048941e-b9b0-4d40-96bd-66f7a5b0bd5e 76237-175 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide CAPSULE, GELATIN COATED ORAL 19961227 NDA AUTHORIZED GENERIC NDA020504 McKesson Contract Packaging HYDROCHLOROTHIAZIDE 12.5 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 76237-176_329f0bd2-e285-4d97-b3c1-f710699a0f41 76237-176 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20111012 ANDA ANDA040412 McKesson Contract Packaging HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] E 20171231 76237-177_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-177 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111005 ANDA ANDA040400 McKesson Contract Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 76237-178_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-178 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111017 ANDA ANDA040201 McKesson Contract Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 76237-179_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-179 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111122 ANDA ANDA040084 McKesson Contract Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 650 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 76237-180_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-180 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111010 ANDA ANDA040409 McKesson Contract Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 76237-181_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-181 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111010 ANDA ANDA089160 McKesson Contract Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 76237-182_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-182 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111006 ANDA ANDA040405 McKesson Contract Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 76237-183_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-183 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111017 ANDA ANDA040201 McKesson Contract Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 500 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 76237-185_a6de48ff-3c76-451c-94f7-de8e8df694b2 76237-185 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111104 ANDA ANDA040084 McKesson Contract Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 750 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 76237-186_7e5df0ab-3d66-43c8-80a6-f1ad8a95b43c 76237-186 HUMAN PRESCRIPTION DRUG Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride TABLET, FILM COATED ORAL 20120123 ANDA ANDA040787 McKesson Contract Packaging HYDROXYZINE HYDROCHLORIDE 25 mg/1 Antihistamine [EPC],Histamine Receptor Antagonists [MoA] N 20181231 76237-187_85b6a65b-fde0-47bf-91a1-4acc6d7d5846 76237-187 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20120105 ANDA ANDA078558 McKesson Contract Packaging IBUPROFEN 400 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 76237-188_85b6a65b-fde0-47bf-91a1-4acc6d7d5846 76237-188 HUMAN PRESCRIPTION DRUG Ibuprofen Ibuprofen TABLET ORAL 20111222 ANDA ANDA078558 McKesson Contract Packaging IBUPROFEN 600 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 76237-189_778d36de-3d3b-4d56-9e33-3cc2a3178c7a 76237-189 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 20110922 ANDA ANDA086066 McKesson Contract Packaging ISOSORBIDE DINITRATE 10 mg/1 E 20171231 76237-190_778d36de-3d3b-4d56-9e33-3cc2a3178c7a 76237-190 HUMAN PRESCRIPTION DRUG Isosorbide Isosorbide Dinitrate TABLET ORAL 20111104 ANDA ANDA088088 McKesson Contract Packaging ISOSORBIDE DINITRATE 20 mg/1 E 20171231 76237-191_f160ab83-126f-4e99-845a-7b27622c377f 76237-191 HUMAN PRESCRIPTION DRUG Isosorbide mononitrate Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110913 ANDA ANDA076813 McKesson Contract Packaging ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 76237-192_f160ab83-126f-4e99-845a-7b27622c377f 76237-192 HUMAN PRESCRIPTION DRUG Isosorbide mononitrate Isosorbide mononitrate TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111128 ANDA ANDA076813 McKesson Contract Packaging ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 76237-193_c555224c-2d01-4dc7-b5de-6edf095d6313 76237-193 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20111205 ANDA ANDA074726 McKesson Contract Packaging POTASSIUM CHLORIDE 1500 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 76237-194_c555224c-2d01-4dc7-b5de-6edf095d6313 76237-194 HUMAN PRESCRIPTION DRUG Klor-Con M Potassium Chloride TABLET, EXTENDED RELEASE ORAL 20111207 ANDA ANDA074726 McKesson Contract Packaging POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 76237-195_234ea375-5df6-4e0e-b3bc-2a08fa5a0b11 76237-195 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20110901 ANDA ANDA078402 McKesson Contract Packaging LISINOPRIL 2.5 mg/1 E 20171231 76237-196_234ea375-5df6-4e0e-b3bc-2a08fa5a0b11 76237-196 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20110907 ANDA ANDA078402 McKesson Contract Packaging LISINOPRIL 5 mg/1 E 20171231 76237-197_234ea375-5df6-4e0e-b3bc-2a08fa5a0b11 76237-197 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20110908 ANDA ANDA078402 McKesson Contract Packaging LISINOPRIL 10 mg/1 E 20171231 76237-198_234ea375-5df6-4e0e-b3bc-2a08fa5a0b11 76237-198 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20110909 ANDA ANDA078402 McKesson Contract Packaging LISINOPRIL 20 mg/1 E 20171231 76237-199_234ea375-5df6-4e0e-b3bc-2a08fa5a0b11 76237-199 HUMAN PRESCRIPTION DRUG Lisinopril lisinopril TABLET ORAL 20110916 ANDA ANDA078402 McKesson Contract Packaging LISINOPRIL 40 mg/1 E 20171231 76237-200_39deeb78-f9c3-421e-8455-ff5ab6820718 76237-200 HUMAN PRESCRIPTION DRUG Loperamide Hydrochloride loperamide hydrochloride CAPSULE ORAL 20120126 ANDA ANDA072741 McKesson Contract Packaging LOPERAMIDE HYDROCHLORIDE 2 mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] E 20171231 76237-201_7145015c-8c81-4ca2-9a7d-e6b71d789707 76237-201 HUMAN OTC DRUG Loratadine Loratadine TABLET ORAL 20110926 ANDA ANDA075209 McKesson Contract Packaging LORATADINE 10 mg/1 E 20171231 76237-202_0d266c0d-167c-4a28-a6ef-924d5d117e50 76237-202 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20111223 ANDA ANDA077936 McKesson Contract Packaging MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 76237-205_9558e870-aa8b-4646-a701-1e9416c02f11 76237-205 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide Hydrochloride TABLET ORAL 20111004 ANDA ANDA072801 McKesson Contract Packaging METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 76237-206_201e71d6-6a69-4ca8-9eb6-9821f45f8d18 76237-206 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide hydrochloride TABLET ORAL 20110930 ANDA ANDA070581 McKesson Contract Packaging METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 76237-207_d2fbe47f-2f30-4442-857d-c6b517a2c5e4 76237-207 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate metoprolol tartrate TABLET, FILM COATED ORAL 20111006 ANDA ANDA076704 McKesson Contract Packaging METOPROLOL TARTRATE 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 76237-208_d0f4d3f2-af08-447a-848f-cfd7bddd2034 76237-208 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20111004 ANDA ANDA074644 McKesson Contract Packaging METOPROLOL TARTRATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 76237-209_d0f4d3f2-af08-447a-848f-cfd7bddd2034 76237-209 HUMAN PRESCRIPTION DRUG Metoprolol Tartrate Metoprolol tartrate TABLET ORAL 20111104 ANDA ANDA074644 McKesson Contract Packaging METOPROLOL TARTRATE 100 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 76237-210_d9578264-6ae5-44e3-90af-6ba61fe270a5 76237-210 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20111026 ANDA ANDA076122 McKesson Contract Packaging MIRTAZAPINE 15 mg/1 E 20171231 76237-211_d9578264-6ae5-44e3-90af-6ba61fe270a5 76237-211 HUMAN PRESCRIPTION DRUG Mirtazapine Mirtazapine TABLET ORAL 20120131 ANDA ANDA076122 McKesson Contract Packaging MIRTAZAPINE 30 mg/1 E 20171231 76237-214_b62dfe64-7212-48ae-b8cd-d426c7f178cd 76237-214 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20120125 ANDA ANDA074201 McKesson Contract Packaging NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] E 20171231 76237-215_25f60261-6c53-42ac-905b-48f7ee87589d 76237-215 HUMAN PRESCRIPTION DRUG Omeprazole Omeprazole CAPSULE, DELAYED RELEASE ORAL 20030128 ANDA ANDA075757 McKesson Contract Packaging OMEPRAZOLE 20 mg/1 Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA] E 20171231 76237-216_0c019ff6-ce85-4711-a9d1-39804ebfae56 76237-216 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET ORAL 20111223 ANDA ANDA075079 McKesson Contract Packaging OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 76237-217_e2d6e56e-43dc-4724-a158-0a690c644d97 76237-217 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20111012 ANDA ANDA076702 McKesson Contract Packaging OXYBUTYNIN CHLORIDE 5 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 76237-218_e2d6e56e-43dc-4724-a158-0a690c644d97 76237-218 HUMAN PRESCRIPTION DRUG Oxybutynin Chloride oxybutynin chloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20110919 ANDA ANDA076644 McKesson Contract Packaging OXYBUTYNIN CHLORIDE 10 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] E 20171231 76237-221_ea2e434b-c25a-4761-a81c-a4a1a0e0d579 76237-221 HUMAN PRESCRIPTION DRUG Paroxetine Paroxetine Hydrochloride TABLET, FILM COATED ORAL 20110916 ANDA ANDA077584 McKesson Contract Packaging PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 76237-222_4d2db83d-8df4-46de-bf04-91405a166b8d 76237-222 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20120220 UNAPPROVED DRUG OTHER McKesson Contract Packaging PHENOBARBITAL 15 mg/1 CIV E 20171231 76237-223_4d2db83d-8df4-46de-bf04-91405a166b8d 76237-223 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20111024 UNAPPROVED DRUG OTHER McKesson Contract Packaging PHENOBARBITAL 30 mg/1 CIV E 20171231 76237-224_4d2db83d-8df4-46de-bf04-91405a166b8d 76237-224 HUMAN PRESCRIPTION DRUG Phenobarbital Phenobarbital TABLET ORAL 20111114 UNAPPROVED DRUG OTHER McKesson Contract Packaging PHENOBARBITAL 60 mg/1 CIV E 20171231 76237-225_6b902d5e-1526-4f80-bb31-57c1b4e5a4f5 76237-225 HUMAN PRESCRIPTION DRUG Pentoxifylline Pentoxifylline TABLET, FILM COATED, EXTENDED RELEASE ORAL 20120130 ANDA ANDA074425 McKesson Contract Packaging PENTOXIFYLLINE 400 mg/1 Blood Viscosity Reducer [EPC],Hematologic Activity Alteration [PE] E 20171231 76237-226_c020c1e8-5d37-4e7e-a7c2-b7ded1b8a60b 76237-226 HUMAN PRESCRIPTION DRUG Phenytoin Sodium phenytoin sodium CAPSULE, EXTENDED RELEASE ORAL 20110919 ANDA ANDA040298 McKesson Contract Packaging PHENYTOIN SODIUM 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA] E 20171231 76237-227_f55cecd1-013d-4db5-9d62-e2cd53f253e4 76237-227 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20111012 ANDA ANDA080352 McKesson Contract Packaging PREDNISONE 5 mg/1 E 20171231 76237-228_f55cecd1-013d-4db5-9d62-e2cd53f253e4 76237-228 HUMAN PRESCRIPTION DRUG PredniSONE PredniSONE TABLET ORAL 20111220 ANDA ANDA084122 McKesson Contract Packaging PREDNISONE 10 mg/1 E 20171231 76237-229_4e6e3e52-a978-4550-be38-21e74bda5a6a 76237-229 HUMAN PRESCRIPTION DRUG Primidone Primidone TABLET ORAL 20111227 ANDA ANDA084903 McKesson Contract Packaging PRIMIDONE 50 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76237-230_0af133fc-a27d-4099-908a-0bdf7c64f22b 76237-230 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride Promethazine Hydrochloride TABLET ORAL 20110914 ANDA ANDA084234 McKesson Contract Packaging PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 76237-231_474075ad-691d-4d9b-8b4c-b661a48a76f0 76237-231 HUMAN PRESCRIPTION DRUG Ranitidine Ranitidine TABLET, FILM COATED ORAL 20111026 ANDA ANDA075165 McKesson Contract Packaging RANITIDINE HYDROCHLORIDE 150 mg/1 Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] E 20171231 76237-232_1b8dae50-1ae4-4cad-859d-feac54d06abc 76237-232 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20111013 ANDA ANDA076288 McKesson Contract Packaging RISPERIDONE .25 mg/1 Atypical Antipsychotic [EPC] E 20171231 76237-233_1b8dae50-1ae4-4cad-859d-feac54d06abc 76237-233 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20111013 ANDA ANDA076288 McKesson Contract Packaging RISPERIDONE .5 mg/1 Atypical Antipsychotic [EPC] E 20171231 76237-234_1b8dae50-1ae4-4cad-859d-feac54d06abc 76237-234 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20110922 ANDA ANDA072688 McKesson Contract Packaging RISPERIDONE 1 mg/1 Atypical Antipsychotic [EPC] E 20171231 76237-235_1b8dae50-1ae4-4cad-859d-feac54d06abc 76237-235 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20110914 ANDA ANDA072688 McKesson Contract Packaging RISPERIDONE 2 mg/1 Atypical Antipsychotic [EPC] E 20171231 76237-236_1b8dae50-1ae4-4cad-859d-feac54d06abc 76237-236 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20120103 ANDA ANDA072688 McKesson Contract Packaging RISPERIDONE 3 mg/1 Atypical Antipsychotic [EPC] E 20171231 76237-237_5ab88ada-8c6d-4cda-a8ef-8ab07cc53a9a 76237-237 HUMAN OTC DRUG Senna-Lax SENNOSIDES A AND B TABLET, FILM COATED ORAL 20110928 OTC MONOGRAPH NOT FINAL part334 McKesson Contract Packaging SENNOSIDES A AND B 8.6 mg/1 E 20171231 76237-239_22cb97e4-02b9-4e7b-8540-14659739dad4 76237-239 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110927 ANDA ANDA077397 McKesson Contract Packaging SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 76237-240_22cb97e4-02b9-4e7b-8540-14659739dad4 76237-240 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110927 ANDA ANDA077397 McKesson Contract Packaging SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 76237-241_22cb97e4-02b9-4e7b-8540-14659739dad4 76237-241 HUMAN PRESCRIPTION DRUG Sertraline Hydrochloride Sertraline Hydrochloride TABLET ORAL 20110927 ANDA ANDA077397 McKesson Contract Packaging SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 76237-242_dcd8802a-bf53-40da-8489-686f4a0610b3 76237-242 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111013 ANDA ANDA077752 McKesson Contract Packaging SIMVASTATIN 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 76237-243_dcd8802a-bf53-40da-8489-686f4a0610b3 76237-243 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20110818 ANDA ANDA077752 McKesson Contract Packaging SIMVASTATIN 20 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 76237-244_dcd8802a-bf53-40da-8489-686f4a0610b3 76237-244 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20111014 ANDA ANDA077752 McKesson Contract Packaging SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 76237-246_6ac04cc4-b044-45a3-ac41-a4dfc4969697 76237-246 HUMAN PRESCRIPTION DRUG Spironolactone spironolactone TABLET, FILM COATED ORAL 20111207 ANDA ANDA040424 McKesson Contract Packaging SPIRONOLACTONE 25 mg/1 Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA] E 20171231 76237-247_2bde09da-d053-447e-84e5-a3cc29abd91b 76237-247 HUMAN PRESCRIPTION DRUG Sucralfate Sucralfate TABLET ORAL 20111129 ANDA ANDA070848 McKesson Contract Packaging SUCRALFATE 1 g/1 Aluminum Complex [EPC],Organometallic Compounds [Chemical/Ingredient] E 20171231 76237-248_24b0946d-25dd-457b-b1bf-7fbc7521a84b 76237-248 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20110922 ANDA ANDA076899 McKesson Contract Packaging SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] E 20171231 76237-250_3a334e15-2b7f-4d75-8df4-d50f047ec831 76237-250 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20111206 ANDA ANDA071427 McKesson Contract Packaging TEMAZEPAM 15 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-251_3a334e15-2b7f-4d75-8df4-d50f047ec831 76237-251 HUMAN PRESCRIPTION DRUG Temazepam Temazepam CAPSULE ORAL 20111121 ANDA ANDA071428 McKesson Contract Packaging TEMAZEPAM 30 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-252_d0d913a9-cfe8-4a7e-b20d-ea51828a01a1 76237-252 HUMAN PRESCRIPTION DRUG Tizanidine Tizanidine TABLET ORAL 20120223 ANDA ANDA076286 McKesson Contract Packaging TIZANIDINE HYDROCHLORIDE 4 mg/1 Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC] E 20171231 76237-253_376c3363-2a07-4ddf-8b31-8c32fbe1e99a 76237-253 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride tramadol hydrochloride TABLET, FILM COATED ORAL 20111019 ANDA ANDA075986 McKesson Contract Packaging TRAMADOL HYDROCHLORIDE 50 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV E 20171231 76237-254_072c4627-897d-4659-bbb3-aa3777e161de 76237-254 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20111011 ANDA ANDA071523 McKesson Contract Packaging TRAZODONE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 76237-255_072c4627-897d-4659-bbb3-aa3777e161de 76237-255 HUMAN PRESCRIPTION DRUG Trazodone Hydrochloride Trazodone Hydrochloride TABLET ORAL 20120125 ANDA ANDA071524 McKesson Contract Packaging TRAZODONE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC] E 20171231 76237-257_d8e85f5e-381a-485b-9aba-78fa0837aab0 76237-257 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20111020 ANDA ANDA077322 McKesson Contract Packaging ZOLPIDEM TARTRATE 5 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 76237-258_d8e85f5e-381a-485b-9aba-78fa0837aab0 76237-258 HUMAN PRESCRIPTION DRUG Zolpidem Tartrate Zolpidem Tartrate TABLET, FILM COATED ORAL 20111021 ANDA ANDA077322 McKesson Contract Packaging ZOLPIDEM TARTRATE 10 mg/1 gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [Chemical/Ingredient],Central Nervous System Depression [PE] CIV E 20171231 76237-259_b4b398bc-399c-4832-adef-baf2019c633d 76237-259 HUMAN PRESCRIPTION DRUG Carbidopa and Levodopa carbidopa and levodopa TABLET, EXTENDED RELEASE ORAL 20120208 ANDA ANDA075091 McKesson Contract Packaging CARBIDOPA; LEVODOPA 50; 200 mg/1; mg/1 Aromatic Amino Acid Decarboxylation Inhibitor [EPC],DOPA Decarboxylase Inhibitors [MoA],Aromatic Amino Acid [EPC],Amino Acids, Aromatic [Chemical/Ingredient] E 20171231 76237-260_d7583513-56e8-4e9e-a7b9-f56cb15e85b6 76237-260 HUMAN PRESCRIPTION DRUG Haloperidol haloperidol TABLET ORAL 20130410 ANDA ANDA070278 McKesson Contract Packaging HALOPERIDOL 5 mg/1 Typical Antipsychotic [EPC] E 20171231 76237-261_867fb3a7-615d-4e06-9a9c-1c6a0285bbc0 76237-261 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20120321 ANDA ANDA074787 McKesson Contract Packaging LABETALOL HYDROCHLORIDE 200 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 76237-262_2c979c14-8820-4101-8ecd-f6efb2dddcc7 76237-262 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20111130 ANDA ANDA076388 McKesson Contract Packaging LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 76237-263_2c979c14-8820-4101-8ecd-f6efb2dddcc7 76237-263 HUMAN PRESCRIPTION DRUG Lamotrigine Lamotrigine TABLET ORAL 20130513 ANDA ANDA076388 McKesson Contract Packaging LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] E 20171231 76237-264_f44e0069-84cf-40e2-a4e8-57494131c65d 76237-264 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20111012 ANDA ANDA076919 McKesson Contract Packaging LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76237-265_f44e0069-84cf-40e2-a4e8-57494131c65d 76237-265 HUMAN PRESCRIPTION DRUG Levetiracetam levetiracetam TABLET, FILM COATED ORAL 20111123 ANDA ANDA076919 McKesson Contract Packaging LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76237-269_1b8dae50-1ae4-4cad-859d-feac54d06abc 76237-269 HUMAN PRESCRIPTION DRUG Risperidone risperidone TABLET, FILM COATED ORAL 20130513 ANDA ANDA076288 McKesson Contract Packaging RISPERIDONE 4 mg/1 Atypical Antipsychotic [EPC] E 20171231 76237-270_dcab3f2d-1b03-4316-8540-9f974c289215 76237-270 HUMAN PRESCRIPTION DRUG Meclizine Hydrochloride meclizine hydrochloride TABLET ORAL 20120103 ANDA ANDA087128 McKesson Contract Packaging MECLIZINE HYDROCHLORIDE 25 mg/1 Antiemetic [EPC],Emesis Suppression [PE] E 20171231 76237-271_c6c86ef1-5a9d-4fa8-9996-d61d3c5f5f16 76237-271 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120118 ANDA ANDA075978 McKesson Contract Packaging METFORMIN HYDROCHLORIDE 1000 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 76237-272_c6c86ef1-5a9d-4fa8-9996-d61d3c5f5f16 76237-272 HUMAN PRESCRIPTION DRUG Metformin Hydrochloride Metformin Hydrochloride TABLET, FILM COATED ORAL 20120117 ANDA ANDA075978 McKesson Contract Packaging METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] E 20171231 76237-273_097505e3-6abd-490d-89b9-334944c59b04 76237-273 HUMAN PRESCRIPTION DRUG promethazine hydrochloride promethazine hydrochloride TABLET ORAL 20120202 ANDA ANDA040863 McKesson Contract Packaging PROMETHAZINE HYDROCHLORIDE 25 mg/1 Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] E 20171231 76237-274_4c29b6c0-174b-4de2-b1da-7033397db7d3 76237-274 HUMAN PRESCRIPTION DRUG benztropine mesylate benztropine mesylate TABLET ORAL 20130221 ANDA ANDA040103 McKesson Contract Packaging BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 76237-275_4c29b6c0-174b-4de2-b1da-7033397db7d3 76237-275 HUMAN PRESCRIPTION DRUG benztropine mesylate benztropine mesylate TABLET ORAL 20120207 ANDA ANDA040103 McKesson Contract Packaging BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] E 20171231 76237-276_894ece20-b681-4b7b-a452-113844594b31 76237-276 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine CAPSULE ORAL 20120416 ANDA ANDA076001 McKesson Contract Packaging FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 76237-277_bd50c5cf-37b6-46af-9b53-6b018e872cef 76237-277 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20130410 ANDA ANDA201001 McKesson Contract Packaging DONEPEZIL HYDROCHLORIDE 5 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 76237-278_bd50c5cf-37b6-46af-9b53-6b018e872cef 76237-278 HUMAN PRESCRIPTION DRUG Donepezil hydrochloride Donepezil hydrochloride TABLET, FILM COATED ORAL 20130410 ANDA ANDA201001 McKesson Contract Packaging DONEPEZIL HYDROCHLORIDE 10 mg/1 Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] E 20171231 76237-279_997a751c-9ce1-4089-872b-380abed42706 76237-279 HUMAN PRESCRIPTION DRUG potassium chloride potassium chloride CAPSULE, EXTENDED RELEASE ORAL 20130415 NDA AUTHORIZED GENERIC NDA018238 McKesson Contract Packaging POTASSIUM CHLORIDE 750 mg/1 Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA] E 20171231 76237-280_4d201395-b244-423f-9f6b-91f88cca6971 76237-280 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20130409 ANDA ANDA077728 McKesson Contract Packaging CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 76237-282_12049b80-7800-4f13-a799-45009661b8d1 76237-282 HUMAN OTC DRUG mapap arthritis pain Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE ORAL 20130409 ANDA ANDA075077 McKesson Contract Packaging ACETAMINOPHEN 650 mg/1 E 20171231 76237-284_d1f6fa09-cea1-4086-8c2a-e27e9a409253 76237-284 HUMAN PRESCRIPTION DRUG Losartan Potassium Losartan Potassium TABLET, FILM COATED ORAL 20130410 ANDA ANDA076958 McKesson Contract Packaging LOSARTAN POTASSIUM 50 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] E 20171231 76237-285_1fea6d90-2211-4005-b8b1-280b9abf59c7 76237-285 HUMAN PRESCRIPTION DRUG Pravastatin Sodium Pravastatin Sodium TABLET ORAL 20130412 ANDA ANDA076056 McKesson Contract Packaging PRAVASTATIN SODIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 76237-286_148826a2-5a25-4e70-a086-a2f04eff9849 76237-286 HUMAN PRESCRIPTION DRUG Tamsulosin Hydrochloride tamsulosin hydrochloride CAPSULE ORAL 20130510 ANDA ANDA090408 McKesson Contract Packaging TAMSULOSIN HYDROCHLORIDE .4 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] E 20171231 76237-289_62b4c73b-416b-4cbc-af96-37e703ff6078 76237-289 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20120828 ANDA ANDA077657 McKesson Contract Packaging LORAZEPAM .5 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-290_62b4c73b-416b-4cbc-af96-37e703ff6078 76237-290 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20120907 ANDA ANDA077657 McKesson Contract Packaging LORAZEPAM 1 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-291_62b4c73b-416b-4cbc-af96-37e703ff6078 76237-291 HUMAN PRESCRIPTION DRUG Lorazepam lorazepam TABLET ORAL 20121018 ANDA ANDA077657 McKesson Contract Packaging LORAZEPAM 2 mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] CIV E 20171231 76237-294_30198c4d-0f5e-4de5-a314-e134890d5983 76237-294 HUMAN PRESCRIPTION DRUG DIGOX Digoxin TABLET ORAL 20120928 ANDA ANDA076268 McKesson Contract Packaging DIGOXIN 125 ug/1 Cardiac Glycoside [EPC],Cardiac Glycosides [Chemical/Ingredient] E 20171231 76237-296_48d366cd-69c1-459a-b1f1-25e470184d3a 76237-296 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20121026 ANDA ANDA077691 McKesson Contract Packaging SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 76237-297_48d366cd-69c1-459a-b1f1-25e470184d3a 76237-297 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20130219 ANDA ANDA077691 McKesson Contract Packaging SIMVASTATIN 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 76237-299_aaa54641-99e7-4082-83ae-8a7c84fcae04 76237-299 HUMAN PRESCRIPTION DRUG Metoclopramide Metoclopramide TABLET ORAL 20130314 ANDA ANDA070581 McKesson Contract Packager METOCLOPRAMIDE HYDROCHLORIDE 10 mg/1 Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC] E 20171231 76237-300_b407f9c5-721e-4cfd-8bc2-b22c8646bc29 76237-300 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20130328 ANDA ANDA090598 McKesson Contract Packaging ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 76237-301_b407f9c5-721e-4cfd-8bc2-b22c8646bc29 76237-301 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20130228 ANDA ANDA090598 McKesson Contract Packaging ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 76237-302_891194e8-7083-4438-8d27-c72f2372e40f 76237-302 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130613 ANDA ANDA200270 McKesson Contract Packaging ISOSORBIDE MONONITRATE 30 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 76237-303_891194e8-7083-4438-8d27-c72f2372e40f 76237-303 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate isosorbide mononitrate TABLET, EXTENDED RELEASE ORAL 20130613 ANDA ANDA200495 McKesson Contract Packaging ISOSORBIDE MONONITRATE 60 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] E 20171231 76237-304_194344a6-13c8-4b24-9ad9-8fe0adcf0485 76237-304 HUMAN PRESCRIPTION DRUG Lisinopril 2.5mg Lisinopril TABLET ORAL 20130801 ANDA ANDA075994 Mckesson Contract Packaging LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 76237-307_194344a6-13c8-4b24-9ad9-8fe0adcf0485 76237-307 HUMAN PRESCRIPTION DRUG Lisinopril 5mg Lisinopril TABLET ORAL 20130801 ANDA ANDA075994 Mckesson Contract Packaging LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 76237-309_194344a6-13c8-4b24-9ad9-8fe0adcf0485 76237-309 HUMAN PRESCRIPTION DRUG Lisinopril 10mg Lisinopril TABLET ORAL 20130801 ANDA ANDA075994 Mckesson Contract Packaging LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 76237-312_194344a6-13c8-4b24-9ad9-8fe0adcf0485 76237-312 HUMAN PRESCRIPTION DRUG Lisinopril 20mg Lisinopril TABLET ORAL 20130801 ANDA ANDA075994 Mckesson Contract Packaging LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 76237-314_194344a6-13c8-4b24-9ad9-8fe0adcf0485 76237-314 HUMAN PRESCRIPTION DRUG Lisinopril 40mg Lisinopril TABLET ORAL 20130801 ANDA ANDA075994 Mckesson Contract Packaging LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] E 20171231 76237-315_a3dba79a-a210-426c-bb16-b5fcad72f577 76237-315 HUMAN OTC DRUG SENEXON-S DOCUSATE SODIUM -SENNOSIDES TABLET, COATED ORAL 20130729 OTC MONOGRAPH NOT FINAL part334 McKesson Contract Packaging DOCUSATE SODIUM; SENNOSIDES A AND B 50; 8.6 mg/1; mg/1 E 20171231 76237-316_5a5588f0-9452-4e48-8876-6dafbf37a767 76237-316 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin CAPSULE ORAL 20140317 ANDA ANDA075350 McKesson Contract Packaging GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76237-336_1b613496-07ab-4e62-9e80-1dcebea58ed6 76237-336 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111010 ANDA ANDA040409 McKesson Contract Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 76237-400_1b613496-07ab-4e62-9e80-1dcebea58ed6 76237-400 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111006 ANDA ANDA040405 McKesson Contract Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 7.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 76237-401_ffd386ad-581c-4ca9-b7de-3b4ac3e08330 76237-401 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate Quetiapine Fumarate TABLET, FILM COATED ORAL 20120327 ANDA ANDA077745 McKesson Contract Packaging QUETIAPINE FUMARATE 100 mg/1 Atypical Antipsychotic [EPC] E 20171231 76237-402_750554ec-c018-4ac9-9b15-6105b3a68630 76237-402 HUMAN PRESCRIPTION DRUG Escitalopram Escitalopram TABLET, FILM COATED ORAL 20120314 ANDA ANDA076765 McKesson Contract Packaging ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 76237-403_1d04135b-12dc-4697-9195-ecad1d69c991 76237-403 HUMAN PRESCRIPTION DRUG Metoprolol succinate Metoprolol succinate TABLET, EXTENDED RELEASE ORAL 20120910 ANDA ANDA090617 McKesson Contract Packaging METOPROLOL SUCCINATE 50 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] E 20171231 76237-515_1b613496-07ab-4e62-9e80-1dcebea58ed6 76237-515 HUMAN PRESCRIPTION DRUG HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ORAL 20111005 ANDA ANDA040400 McKesson Contract Packaging HYDROCODONE BITARTRATE; ACETAMINOPHEN 10; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CII E 20171231 76245-017_eba8ea81-ef50-41de-a2cd-21338dbdd842 76245-017 HUMAN OTC DRUG True Natural NEUTRAL 50 ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20170201 OTC MONOGRAPH FINAL part352 True Nature Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 22.5; 6 g/100mL; g/100mL N 20181231 76245-018_4170a378-0b9d-4011-a757-5356a6c2ba8d 76245-018 HUMAN OTC DRUG true natural Caribbean Coconut 30 ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20170201 OTC MONOGRAPH FINAL part352 True Nature Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 6; 6 g/100mL; g/100mL N 20181231 76245-019_2f30b0d6-9f7f-48f8-bd6a-2106428102c4 76245-019 HUMAN OTC DRUG true natural baby 30 and family ZINC OXIDE, TITANIUM DIOXIDE LOTION TOPICAL 20170201 OTC MONOGRAPH FINAL part352 True Nature Group, Inc. ZINC OXIDE; TITANIUM DIOXIDE 6; 6 g/100mL; g/100mL N 20181231 76245-101_278a47b1-084b-47b8-8a58-e5bd85483d8f 76245-101 HUMAN OTC DRUG SK1N NATURAL SUNSCREEN SPF 20 ZINC OXIDE LOTION TOPICAL 19960101 OTC MONOGRAPH NOT FINAL part352 True Nature Group, Inc. ZINC OXIDE 19 g/142g E 20171231 76245-102_c7175015-e944-452c-af7c-67e5e1d27330 76245-102 HUMAN OTC DRUG SK1N NATURAL SUNSCREEN SPF 40 ZINC OXIDE LOTION TOPICAL 19960101 OTC MONOGRAPH NOT FINAL part352 True Nature Group, Inc. ZINC OXIDE 25 g/142g E 20171231 76245-216_d3dc37cd-b99c-4d88-8c4d-db7c55dddf43 76245-216 HUMAN OTC DRUG True Natural broad sptectum spf 50 Unscented face and sensitive skin ZINC OXIDE CREAM TOPICAL 20120312 OTC MONOGRAPH FINAL part347 True Nature Group, Inc. ZINC OXIDE 10 mL/50mL E 20171231 76245-217_d893b899-abf8-4e47-af34-a76be7ab0445 76245-217 HUMAN OTC DRUG True Natural broad spectrum spf 50 all natural vanilla-coconut sunscreen ZINC OXIDE SPRAY TOPICAL 20120312 OTC MONOGRAPH FINAL part347 True Nature Group, Inc. ZINC OXIDE 24 mL/120mL E 20171231 76245-218_0285e5bd-0b83-49f1-94e0-0760c647ff62 76245-218 HUMAN OTC DRUG True Natural broad spectrum spf 50 all natural vanilla-coconut sunscreen ZINC OXIDE LOTION TOPICAL 20120312 OTC MONOGRAPH FINAL part347 True Nature Group, Inc. ZINC OXIDE 20 mL/100mL E 20171231 76245-219_17060d05-3987-4fd8-9399-17f7105453ab 76245-219 HUMAN OTC DRUG True Natural broad spectrum spf 50 all natural baby and sensitive skin sunscreen ZINC OXIDE LOTION TOPICAL 20120312 OTC MONOGRAPH FINAL part347 True Nature Group, Inc. ZINC OXIDE 20 mL/100mL E 20171231 76245-220_c4262e75-f650-4038-97ea-9f348625103f 76245-220 HUMAN OTC DRUG True Natural broad spectrum spf 50 all natural sunscreen Limited Edition ZINC OXIDE CREAM TOPICAL 20120312 OTC MONOGRAPH FINAL part347 True Nature Group, Inc. ZINC OXIDE 10 mL/50mL E 20171231 76250-110_f679c9ef-689d-4953-a6d2-f85e21787fc8 76250-110 HUMAN OTC DRUG E3 Foaming Hand Sanitizer Problend benzalkonium chloride LIQUID TOPICAL 20130508 OTC MONOGRAPH NOT FINAL part333E Seatex Ltd BENZALKONIUM CHLORIDE 1 g/1000mL E 20171231 76250-1195_f95e9652-ef11-4753-a393-ac948f859891 76250-1195 HUMAN OTC DRUG Antibacterial CHLOROXYLENOL SOAP TOPICAL 20110914 OTC MONOGRAPH NOT FINAL part333E Seatex Ltd CHLOROXYLENOL 40 g/kg E 20171231 76250-123_266fc891-6cb4-4b54-b447-56ad6ce6ee2d 76250-123 HUMAN OTC DRUG Antibacterial CHLOROXYLENOL SOAP TOPICAL 20111014 OTC MONOGRAPH NOT FINAL part333E Seatex Ltd CHLOROXYLENOL 40 g/kg E 20171231 76250-495_cd114f15-78fe-4c1d-a483-4cfbaff4d872 76250-495 HUMAN OTC DRUG Seatex Hand Sanitizer ISOPROPYL ALCOHOL GEL TOPICAL 20110701 OTC MONOGRAPH FINAL part344 Seatex Ltd ISOPROPYL ALCOHOL 700 g/kg E 20171231 76250-595_63d97469-eabb-4623-922d-8c0b949b43d3 76250-595 HUMAN OTC DRUG Alcohol Hand Problend ISOPROPYL ALCOHOL GEL TOPICAL 20130809 OTC MONOGRAPH FINAL part344 Seatex Ltd ISOPROPYL ALCOHOL 700 mL/1000mL E 20171231 76250-641_698eb99d-7661-44c2-a2d2-c18c4687a09f 76250-641 HUMAN OTC DRUG Alcohol Hand Sanitizer Problend ISOPROPYL ALCOHOL GEL TOPICAL 20130809 OTC MONOGRAPH FINAL part344 Seatex Ltd ISOPROPYL ALCOHOL 700 mL/1000mL E 20171231 76250-786_f9a666d2-29e0-4918-8848-7ba188774e7f 76250-786 HUMAN OTC DRUG Antibacterial Hand Problend CHLOROXYLENOL SOAP TOPICAL 20110531 OTC MONOGRAPH NOT FINAL part333E Seatex Ltd CHLOROXYLENOL 4 g/1000mL E 20171231 76250-995_4581e04a-bd9e-4989-bce1-3b8cf1d0b420 76250-995 HUMAN OTC DRUG Anti Bacterial Foam Hand Problend benzalkonium chloride SOAP TOPICAL 20120531 OTC MONOGRAPH NOT FINAL part333E Seatex Ltd BENZALKONIUM CHLORIDE 1.3 g/1000mL E 20171231 76254-1001_61620e4e-0ee0-c2f3-e053-2991aa0abc3b 76254-1001 HUMAN OTC DRUG Probee propolis PASTE, DENTIFRICE ORAL 20110810 UNAPPROVED DRUG OTHER Seoul Propolis PROPOLIS WAX 5 g/100g N 20181231 76254-2001_6162c305-e7a6-5020-e053-2991aa0a4aee 76254-2001 HUMAN OTC DRUG Robongbang Propolis propolis CAPSULE ORAL 20110816 UNAPPROVED DRUG OTHER Seoul Propolis PROPOLIS WAX 85 mg/1 N 20181231 76254-3001_648756b1-2113-4fae-a21d-f2c40e308b43 76254-3001 HUMAN OTC DRUG Robongbang water soluble propolis propolis LIQUID ORAL 20110816 UNAPPROVED DRUG OTHER Seoul Propolis PROPOLIS WAX .364 mL/mL E 20171231 76254-4001_e8f4de87-3563-491d-afd9-49fa34491923 76254-4001 HUMAN OTC DRUG Probee water soluble propolis propolis LIQUID ORAL 20110816 UNAPPROVED DRUG OTHER Seoul Propolis PROPOLIS WAX .329 mL/mL E 20171231 76254-5001_64145159-4c6f-4b96-864a-d12ff32a47de 76254-5001 HUMAN OTC DRUG Seoul Propolia propolis LIQUID ORAL 20110816 UNAPPROVED DRUG OTHER Seoul Propolis PROPOLIS WAX .99 mL/mL E 20171231 76255-1001_a9eb2e2a-f4e4-43e5-a7e5-50fc62232080 76255-1001 HUMAN OTC DRUG Volcano Power EUCOMMIA ULMOIDES CAPSULE ORAL 20110611 UNAPPROVED DRUG OTHER H&C 21 America Inc EUCOMMIA ULMOIDES BARK 54 mg/1 E 20171231 76255-2001_dd69ed67-5608-4dbd-9543-48734bef70f7 76255-2001 HUMAN OTC DRUG Letomint clove TABLET ORAL 20110618 UNAPPROVED DRUG OTHER H&C 21 America Inc CLOVE 18 mg/1 E 20171231 76260-101_1f924be6-18a8-4ea6-853e-22e5f661610b 76260-101 HUMAN OTC DRUG Aqua Maris Isotonised Sodium chloride LIQUID NASAL 20011228 UNAPPROVED DRUG OTHER JGL North America LLC SODIUM CHLORIDE 11.25 mg/mL E 20171231 76260-102_d0a918a0-0a5b-4d58-9501-85c29bfbcbe8 76260-102 HUMAN OTC DRUG Aqua Maris Strong Sodium chloride SPRAY NASAL 20090318 UNAPPROVED HOMEOPATHIC JGL North America LLC SODIUM CHLORIDE 37.5 mg/mL E 20171231 76260-103_eca045d7-e921-49ec-af67-2d4f68d717ae 76260-103 HUMAN OTC DRUG Aqua Maris Baby Sodium chloride LIQUID NASAL 20100708 UNAPPROVED DRUG OTHER JGL North America LLC SODIUM CHLORIDE 11.25 mg/mL E 20171231 76260-104_467bad22-2fd7-4009-907e-165168607882 76260-104 HUMAN OTC DRUG Aqua Maris Ear Sodium Chloride SPRAY AURICULAR (OTIC) 20091029 UNAPPROVED DRUG OTHER JGL North America LLC SODIUM CHLORIDE 11.25 mg/mL E 20171231 76260-105_5d386ab7-f2a7-410f-b6f1-9526361da8d7 76260-105 HUMAN OTC DRUG Aqua Maris Throat Sodium chloride SPRAY ORAL 20050420 UNAPPROVED DRUG OTHER JGL North America LLC SODIUM CHLORIDE 37.5 mg/mL E 20171231 76260-106_b70ba985-2894-493f-a4cf-c9102fe36d97 76260-106 HUMAN OTC DRUG Aqua Maris Fast Acting Decongestant Xylometazoline HCL SPRAY NASAL 20121215 OTC MONOGRAPH FINAL part341 JGL North America LLC XYLOMETAZOLINE HYDROCHLORIDE 10 mg/10mL E 20171231 76260-107_28ca2b5e-5642-46ca-9303-8e9a19bec60d 76260-107 HUMAN OTC DRUG Aqua Maris Kids Fast Acting Decongestant Xylometazoline HCL SPRAY NASAL 20100927 OTC MONOGRAPH FINAL part341 JGL North America LLC XYLOMETAZOLINE HYDROCHLORIDE .05 mg/10mL E 20171231 76261-125_a14210e4-bfeb-461a-b6af-87946ec1cd8f 76261-125 HUMAN OTC DRUG ASAP Skin Products Moisturising Daily Defense SPF 30 Octocrylene,Zinc Oxide, Avobenzone, Ensulizone, Titanium Dioxide LOTION TOPICAL 20110603 OTC MONOGRAPH NOT FINAL part352 Australian Skin Products pty ltd OCTOCRYLENE; ZINC OXIDE; AVOBENZONE; ENSULIZOLE; TITANIUM DIOXIDE 6; 2.75; 2; 1.5; 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 76261-126_56f3b078-ed8d-4b8b-9214-43644b68b2b0 76261-126 HUMAN OTC DRUG correcting cream Broad Spectrum SPF 15 asap avobenzone, Octinoxate, Octocrylene, Oxybenzone, Zinc Oxide LOTION TOPICAL 20140804 OTC MONOGRAPH FINAL part352 AUSTRALIAN SKIN PRODUCTS PTY LTD AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE; ZINC OXIDE 3; 4; 2.7; 3; 4.5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL E 20171231 76261-127_76039001-5295-415d-9010-930f5019b7a7 76261-127 HUMAN OTC DRUG Hydrating Lip Balm SPF 15 sunscreen ASAP Avobenzone, Homosalate, Octocrylene, Octisalate GEL TOPICAL 20140807 OTC MONOGRAPH FINAL part352 AUSTRALIAN SKIN PRODUCTS PTY LTD AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE 3.5; 5; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL E 20171231 76261-250_73e7910d-2bc1-4a68-8218-1b7994190391 76261-250 HUMAN OTC DRUG Sheer Tint Moisturizer SPF 15 ASAP Skin Products Titanium Dioxide, Zinc Oxide LOTION TOPICAL 20110602 OTC MONOGRAPH NOT FINAL part352 AUSTRALIAN SKIN PRODUCTS PTY LTD TITANIUM DIOXIDE; ZINC OXIDE 4; 1 g/100mL; g/100mL E 20171231 76267-060_fb817546-31ae-410a-812d-0e5ceafbf1dc 76267-060 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20121231 ANDA ANDA202710 Allied Pharma Inc CLARITHROMYCIN 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 76267-061_fb817546-31ae-410a-812d-0e5ceafbf1dc 76267-061 HUMAN PRESCRIPTION DRUG Clarithromycin Clarithromycin TABLET, FILM COATED ORAL 20121231 ANDA ANDA202710 Allied Pharma Inc CLARITHROMYCIN 500 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] E 20171231 76267-150_cc42779d-9cf2-4dc5-a770-483c0ab7d976 76267-150 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20130602 ANDA ANDA203244 Allied Pharma Inc GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76267-151_cc42779d-9cf2-4dc5-a770-483c0ab7d976 76267-151 HUMAN PRESCRIPTION DRUG Gabapentin Gabapentin TABLET, FILM COATED ORAL 20130602 ANDA ANDA203244 Allied Pharma Inc GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76268-001_d8bd636b-0010-4e50-b3a0-7956e0eb476f 76268-001 HUMAN OTC DRUG Antibacterial Hand Benzalkonium Chloride GEL TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part333A ORGANICA (UK) LTD BENZALKONIUM CHLORIDE .1 mL/100mL E 20171231 76268-002_c0035b50-75c2-46fd-a258-61b36e8eee58 76268-002 HUMAN OTC DRUG Antibacterial Hand Mousse Benzalkonium Chloride LIQUID TOPICAL 20110728 OTC MONOGRAPH NOT FINAL part333A ORGANICA (UK) LTD BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 76269-187_a10f438d-99c3-4183-b39c-3f5cf9d8f9e3 76269-187 HUMAN OTC DRUG Lip Balm Vanilla SPF-15 Octinoxate, Oxybenzone OINTMENT TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part352 Teton Outfitters LLC dba Klim Aggressive Sledwear OCTINOXATE; OXYBENZONE 7.5; 3 g/100g; g/100g N 20181231 76271-001_c6e98d27-268e-4ab6-98d6-746b45d4c56c 76271-001 HUMAN OTC DRUG DR. WALTONS BABY POWDER TALC POWDER TOPICAL 20110709 OTC MONOGRAPH NOT FINAL part347 Dr. Waltons, Incorporated ALPHA-TOCOPHEROL; ZINC OXIDE 5.2; 5.13 g/675g; g/675g E 20171231 76271-002_d5c05f56-3b4d-487b-9cb3-fdd0651d6a06 76271-002 HUMAN OTC DRUG DR WALTONS PETROLEUM PETROLATUM JELLY TOPICAL 20110709 OTC MONOGRAPH FINAL part346 Dr. Waltons, Incorporated PETROLATUM 226 g/226g E 20171231 76271-003_936924f1-0689-445f-99a7-ac3dd7372b06 76271-003 HUMAN OTC DRUG DR. WALTONS COOL AND HOT ANALGESIC MENTHOL GEL TOPICAL 20110714 OTC MONOGRAPH FINAL part346 DR. WALTONS, INCORPORATED MENTHOL 2.27 g/227g E 20171231 76271-004_84149f61-14f9-44af-b3c3-6dec83130e07 76271-004 HUMAN OTC DRUG DR WALTONS VAPOR RUB VAPOR RUB GEL TOPICAL 20110714 OTC MONOGRAPH FINAL part346 DR. WALTONS, INCORPORATED CAMPHOR (SYNTHETIC); MENTHOL; EUCALYPTUS OIL 5.3; 2.26; 1.13 g/113g; g/113g; g/113g E 20171231 76273-001_b36e8ab8-cb05-4d04-951e-7722b38a00bd 76273-001 HUMAN OTC DRUG Antibacterial Hand BENZALKONIUM CHLORIDE GEL TOPICAL 20110727 OTC MONOGRAPH NOT FINAL part333A MAYBORN USA, INC. BENZALKONIUM CHLORIDE .1 mL/100mL E 20171231 76273-002_2d1ede75-60b2-4614-9013-85d33ee09baa 76273-002 HUMAN OTC DRUG Antibacterial Hand Mousse BENZALKONIUM CHLORIDE LIQUID TOPICAL 20110728 OTC MONOGRAPH NOT FINAL part333A MAYBORN USA, INC. BENZALKONIUM CHLORIDE .13 mL/100mL E 20171231 76277-100_c00e2ed3-d977-4ad6-8242-1f7005d60b7e 76277-100 HUMAN OTC DRUG OCUMEND Arnica Montana, Ledum Palustre PELLET ORAL 20120101 UNAPPROVED HOMEOPATHIC Cearna, Inc. ARNICA MONTANA; LEDUM PALUSTRE TWIG 50; 50 [hp_M]/1; [hp_M]/1 E 20171231 76277-211_28f09ade-a67b-4c93-a857-7aece06b3ee6 76277-211 HUMAN OTC DRUG OcuMend Arnica Montana, Ledum Palustre KIT 20120517 UNAPPROVED HOMEOPATHIC Cearna, Inc. E 20171231 76277-612_b459c3dd-79a2-4852-9570-92174f495589 76277-612 HUMAN OTC DRUG OcuMend Healing Gels Arnica Montana, Ledum Palustre PATCH TOPICAL 20120501 UNAPPROVED HOMEOPATHIC Cearna, Inc. ARNICA MONTANA; LEDUM PALUSTRE TWIG 50; 50 [hp_M]/1; [hp_M]/1 E 20171231 76277-613_2e05eba5-fd09-4d7f-e054-00144ff88e88 76277-613 HUMAN OTC DRUG OcuMend Healing Gels Arnica Montana, Ledum Palustre PATCH TOPICAL 20160311 UNAPPROVED HOMEOPATHIC Cearna, Inc. ARNICA MONTANA; LEDUM PALUSTRE TWIG 50; 50 [hp_M]/1; [hp_M]/1 E 20171231 76279-420_72af2948-94c6-4db2-90b3-698291b6f118 76279-420 HUMAN OTC DRUG Softone Luxury Foam Antibacterial Skin Cleanser Triclosan SOLUTION TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part333E Brady Industries LLC TRICLOSAN 5 g/L E 20171231 76280-231_6009debc-61a7-40db-8b65-734349bea03b 76280-231 HUMAN OTC DRUG Octisalate, Avobenzone, Homosalate, Octocrylene SPF30 Julep Solace Oil-Free Sunscreen Broad Spectrum LOTION TOPICAL 20131001 OTC MONOGRAPH NOT FINAL part352 Julep Nail Parlor OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE 5; 3; 5; 2.7 g/89mL; g/89mL; g/89mL; g/89mL N 20181231 76280-232_d979185a-b6d2-4ba5-bfb9-2faf01c277ba 76280-232 HUMAN OTC DRUG Octisalate, Avobenzone, Homosalate, Octocrylene SPF30 Julep Time Machine KIT TOPICAL 20130910 OTC MONOGRAPH NOT FINAL part352 Julep Nail Parlor N 20181231 76281-301_658d8d06-b4b9-49a5-9f32-d5a22033bc59 76281-301 HUMAN OTC DRUG Childrens Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE LIQUID ORAL 20130821 OTC MONOGRAPH FINAL part341 AptaPharma Inc. DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 76281-302_0fa300f5-d15a-4ad7-874e-d4a0bc6a1b94 76281-302 HUMAN OTC DRUG Childrens Pain and Fever ACETAMINOPHEN LIQUID ORAL 20130821 OTC MONOGRAPH NOT FINAL part343 AptaPharma Inc. ACETAMINOPHEN 160 mg/5mL N 20181231 76282-044_d1c6d632-0f87-434e-9d53-e6e9494de738 76282-044 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Exelan Pharmaceuticals, Inc. ARIPIPRAZOLE 2 mg/1 Atypical Antipsychotic [EPC] N 20181231 76282-045_d1c6d632-0f87-434e-9d53-e6e9494de738 76282-045 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Exelan Pharmaceuticals, Inc. ARIPIPRAZOLE 5 mg/1 Atypical Antipsychotic [EPC] N 20181231 76282-046_d1c6d632-0f87-434e-9d53-e6e9494de738 76282-046 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Exelan Pharmaceuticals, Inc. ARIPIPRAZOLE 10 mg/1 Atypical Antipsychotic [EPC] N 20181231 76282-047_d1c6d632-0f87-434e-9d53-e6e9494de738 76282-047 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Exelan Pharmaceuticals, Inc. ARIPIPRAZOLE 15 mg/1 Atypical Antipsychotic [EPC] N 20181231 76282-048_d1c6d632-0f87-434e-9d53-e6e9494de738 76282-048 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Exelan Pharmaceuticals, Inc. ARIPIPRAZOLE 20 mg/1 Atypical Antipsychotic [EPC] N 20181231 76282-049_d1c6d632-0f87-434e-9d53-e6e9494de738 76282-049 HUMAN PRESCRIPTION DRUG Aripiprazole Aripiprazole TABLET ORAL 20150428 ANDA ANDA205064 Exelan Pharmaceuticals, Inc. ARIPIPRAZOLE 30 mg/1 Atypical Antipsychotic [EPC] N 20181231 76282-115_92484eb6-4da8-47b3-b103-e90ec010cb2a 76282-115 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20150429 ANDA ANDA203259 Exelan Pharmaceuticals Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] N 20181231 76282-152_e9208463-3a7e-4ff5-b988-25f7befab9dc 76282-152 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20150414 ANDA ANDA077927 Exelan Pharmaceuticals Inc. MELOXICAM 7.5 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 76282-153_e9208463-3a7e-4ff5-b988-25f7befab9dc 76282-153 HUMAN PRESCRIPTION DRUG Meloxicam Meloxicam TABLET ORAL 20150414 ANDA ANDA077927 Exelan Pharmaceuticals Inc. MELOXICAM 15 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 76282-154_46a90682-6b29-4add-9509-fbf0b1c01f4b 76282-154 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20160830 ANDA ANDA040907 Exelan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 76282-155_46a90682-6b29-4add-9509-fbf0b1c01f4b 76282-155 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20160830 ANDA ANDA040907 Exelan Pharmaceuticals Inc. HYDROCHLOROTHIAZIDE 50 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 76282-200_1e8b9703-41f2-4ce0-963f-0aedc48db2eb 76282-200 HUMAN PRESCRIPTION DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL 20050621 ANDA ANDA077222 Exelan Pharmaceuticals, Inc. FOSINOPRIL SODIUM 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-201_1e8b9703-41f2-4ce0-963f-0aedc48db2eb 76282-201 HUMAN PRESCRIPTION DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL 20050621 ANDA ANDA077222 Exelan Pharmaceuticals, Inc. FOSINOPRIL SODIUM 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-202_1e8b9703-41f2-4ce0-963f-0aedc48db2eb 76282-202 HUMAN PRESCRIPTION DRUG Fosinopril sodium Fosinopril sodium TABLET ORAL 20050621 ANDA ANDA077222 Exelan Pharmaceuticals, Inc. FOSINOPRIL SODIUM 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-206_8b7497d4-b363-448c-98f6-b58b94be9a42 76282-206 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM TABLET ORAL 20121001 ANDA ANDA077534 Exelan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 76282-207_8b7497d4-b363-448c-98f6-b58b94be9a42 76282-207 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM TABLET ORAL 20121001 ANDA ANDA077534 Exelan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 76282-208_8b7497d4-b363-448c-98f6-b58b94be9a42 76282-208 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM TABLET ORAL 20121001 ANDA ANDA077534 Exelan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 40 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 76282-209_b15bcebf-6d1b-4f05-b9e1-c57db7ab6678 76282-209 HUMAN PRESCRIPTION DRUG Terbinafine Terbinafine TABLET ORAL 20120425 ANDA ANDA077533 Exelan Pharmaceuticals Inc. TERBINAFINE HYDROCHLORIDE 250 mg/1 Allylamine [Chemical/Ingredient],Allylamine Antifungal [EPC] N 20181231 76282-210_52fee76e-63de-48e1-aa54-00624dacb178 76282-210 HUMAN PRESCRIPTION DRUG FOLIC ACID FOLIC ACID TABLET ORAL 20100406 ANDA ANDA090035 Exelan Pharmaceuticals, Inc. FOLIC ACID 1 mg/1 N 20181231 76282-212_091e628e-4be0-426f-bdf5-902d3138a0be 76282-212 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline TABLET, FILM COATED ORAL 20120820 ANDA ANDA077397 Exelan Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 25 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 76282-213_091e628e-4be0-426f-bdf5-902d3138a0be 76282-213 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline TABLET, FILM COATED ORAL 20120820 ANDA ANDA077397 Exelan Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 50 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 76282-214_091e628e-4be0-426f-bdf5-902d3138a0be 76282-214 HUMAN PRESCRIPTION DRUG SERTRALINE Sertraline TABLET, FILM COATED ORAL 20120820 ANDA ANDA077397 Exelan Pharmaceuticals, Inc. SERTRALINE HYDROCHLORIDE 100 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 76282-225_31ce640c-5e2a-48b3-b287-898b20fa5f6b 76282-225 HUMAN PRESCRIPTION DRUG Gemfibrozil Gemfibrozil TABLET, FILM COATED ORAL 20061020 ANDA ANDA077836 Exelan Pharmaceuticals, Inc. GEMFIBROZIL 600 mg/1 Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient] N 20181231 76282-228_e9ed770f-ec90-4994-9254-eb0baf8273cb 76282-228 HUMAN PRESCRIPTION DRUG Zonisamide Zonisamide CAPSULE ORAL 20060705 ANDA ANDA077869 Exelan Pharmaceuticals, Inc. ZONISAMIDE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Sulfonamides [Chemical/Ingredient],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 76282-237_6801b4e6-0038-45d1-bfe3-7074734e07d4 76282-237 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20071102 ANDA ANDA077955 Exelan Pharmaceuticals, Inc. AMLODIPINE BESYLATE 2.5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 76282-238_6801b4e6-0038-45d1-bfe3-7074734e07d4 76282-238 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20071102 ANDA ANDA077955 Exelan Pharmaceuticals, Inc. AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 76282-239_6801b4e6-0038-45d1-bfe3-7074734e07d4 76282-239 HUMAN PRESCRIPTION DRUG Amlodipine besylate Amlodipine besylate TABLET ORAL 20071102 ANDA ANDA077955 Exelan Pharmaceuticals, Inc. AMLODIPINE BESYLATE 10 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20191231 76282-246_f4de9358-6b8d-4506-b199-c9ace3d3aa00 76282-246 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078234 Exelan Pharmaceuticals, Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 76282-247_f4de9358-6b8d-4506-b199-c9ace3d3aa00 76282-247 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078234 Exelan Pharmaceuticals, Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 76282-248_f4de9358-6b8d-4506-b199-c9ace3d3aa00 76282-248 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET ORAL 20090115 ANDA ANDA078234 Exelan Pharmaceuticals, Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 76282-249_f68cfc8e-043e-4c5e-bb96-d092cafa2f0d 76282-249 HUMAN PRESCRIPTION DRUG Escitalopram oxalate escitalopram TABLET, FILM COATED ORAL 20121001 ANDA ANDA078604 Exelan Pharmaceuticals Inc. ESCITALOPRAM OXALATE 5 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 76282-250_f68cfc8e-043e-4c5e-bb96-d092cafa2f0d 76282-250 HUMAN PRESCRIPTION DRUG Escitalopram oxalate escitalopram TABLET, FILM COATED ORAL 20121001 ANDA ANDA078604 Exelan Pharmaceuticals Inc. ESCITALOPRAM OXALATE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 76282-251_f68cfc8e-043e-4c5e-bb96-d092cafa2f0d 76282-251 HUMAN PRESCRIPTION DRUG Escitalopram oxalate escitalopram TABLET, FILM COATED ORAL 20121001 ANDA ANDA078604 Exelan Pharmaceuticals Inc. ESCITALOPRAM OXALATE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 76282-256_251edaab-2909-4350-af19-582403272b26 76282-256 HUMAN PRESCRIPTION DRUG Raloxifene Hydrochloride Raloxifene Hydrochloride TABLET, FILM COATED ORAL 20141112 ANDA ANDA090842 Exelan Pharmaceuticals, Inc. RALOXIFENE HYDROCHLORIDE 60 mg/1 Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 76282-257_e13d97fe-fb47-4a47-bbe8-bc1a46ce3e25 76282-257 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20150414 ANDA ANDA078671 Exelan Pharmaceuticals Inc. NABUMETONE 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 76282-258_e13d97fe-fb47-4a47-bbe8-bc1a46ce3e25 76282-258 HUMAN PRESCRIPTION DRUG Nabumetone Nabumetone TABLET, FILM COATED ORAL 20150414 ANDA ANDA078671 Exelan Pharmaceuticals Inc. NABUMETONE 750 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 76282-271_af09ebd5-6988-4e8c-b9b1-8e5e9c9520e3 76282-271 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080627 ANDA ANDA078745 Exelan Pharmaceuticals, Inc. RAMIPRIL 1.25 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-272_af09ebd5-6988-4e8c-b9b1-8e5e9c9520e3 76282-272 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080627 ANDA ANDA078745 Exelan Pharmaceuticals, Inc. RAMIPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-273_af09ebd5-6988-4e8c-b9b1-8e5e9c9520e3 76282-273 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080627 ANDA ANDA078745 Exelan Pharmaceuticals, Inc. RAMIPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-274_af09ebd5-6988-4e8c-b9b1-8e5e9c9520e3 76282-274 HUMAN PRESCRIPTION DRUG Ramipril Ramipril CAPSULE ORAL 20080627 ANDA ANDA078745 Exelan Pharmaceuticals, Inc. RAMIPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-302_19151465-d69a-44b0-b96c-586d2ef70677 76282-302 HUMAN PRESCRIPTION DRUG Alfuzosin hydrochloride Alfuzosin hydrochloride TABLET, EXTENDED RELEASE ORAL 20121002 ANDA ANDA090284 Exelan Pharmaceuticals Inc. ALFUZOSIN HYDROCHLORIDE 10 mg/1 Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC] N 20181231 76282-309_67569d22-7be0-48a8-ad44-0f2785aa3383 76282-309 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20160520 ANDA ANDA090255 Exelan Pharmaceuticals Inc. HYDRALAZINE HYDROCHLORIDE 10 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 76282-310_67569d22-7be0-48a8-ad44-0f2785aa3383 76282-310 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20160520 ANDA ANDA090255 Exelan Pharmaceuticals Inc. HYDRALAZINE HYDROCHLORIDE 25 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 76282-311_67569d22-7be0-48a8-ad44-0f2785aa3383 76282-311 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20160520 ANDA ANDA090255 Exelan Pharmaceuticals Inc. HYDRALAZINE HYDROCHLORIDE 50 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 76282-312_67569d22-7be0-48a8-ad44-0f2785aa3383 76282-312 HUMAN PRESCRIPTION DRUG HydrALAZINE Hydrochloride HydrALAZINE Hydrochloride TABLET ORAL 20160520 ANDA ANDA090255 Exelan Pharmaceuticals Inc. HYDRALAZINE HYDROCHLORIDE 100 mg/1 Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC] N 20181231 76282-321_ff97159a-0208-490f-8d72-0119b4dfa076 76282-321 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20100426 ANDA ANDA090705 Exelan Pharmaceuticals, Inc. GABAPENTIN 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 76282-322_ff97159a-0208-490f-8d72-0119b4dfa076 76282-322 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20100426 ANDA ANDA090705 Exelan Pharmaceuticals, Inc. GABAPENTIN 300 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 76282-323_ff97159a-0208-490f-8d72-0119b4dfa076 76282-323 HUMAN PRESCRIPTION DRUG GABAPENTIN GABAPENTIN CAPSULE ORAL 20100426 ANDA ANDA090705 Exelan Pharmaceuticals, Inc. GABAPENTIN 400 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 76282-327_04382db2-2d2c-41d9-8658-1ddbccb5dfa2 76282-327 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Exelan Pharmaceuticals Inc. WARFARIN SODIUM 1 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 76282-328_04382db2-2d2c-41d9-8658-1ddbccb5dfa2 76282-328 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Exelan Pharmaceuticals Inc. WARFARIN SODIUM 2 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 76282-329_04382db2-2d2c-41d9-8658-1ddbccb5dfa2 76282-329 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Exelan Pharmaceuticals Inc. WARFARIN SODIUM 2.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 76282-330_04382db2-2d2c-41d9-8658-1ddbccb5dfa2 76282-330 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Exelan Pharmaceuticals Inc. WARFARIN SODIUM 3 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 76282-331_04382db2-2d2c-41d9-8658-1ddbccb5dfa2 76282-331 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Exelan Pharmaceuticals Inc. WARFARIN SODIUM 4 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 76282-332_04382db2-2d2c-41d9-8658-1ddbccb5dfa2 76282-332 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Exelan Pharmaceuticals Inc. WARFARIN SODIUM 5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 76282-333_04382db2-2d2c-41d9-8658-1ddbccb5dfa2 76282-333 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Exelan Pharmaceuticals Inc. WARFARIN SODIUM 6 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 76282-334_04382db2-2d2c-41d9-8658-1ddbccb5dfa2 76282-334 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Exelan Pharmaceuticals Inc. WARFARIN SODIUM 7.5 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 76282-335_04382db2-2d2c-41d9-8658-1ddbccb5dfa2 76282-335 HUMAN PRESCRIPTION DRUG Warfarin Sodium Warfarin TABLET ORAL 20150408 ANDA ANDA090935 Exelan Pharmaceuticals Inc. WARFARIN SODIUM 10 mg/1 Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA] N 20181231 76282-336_e6c91bee-5a49-45cd-9813-b10ac3e4833d 76282-336 HUMAN PRESCRIPTION DRUG Trospium Chloride Trospium Chloride TABLET, FILM COATED ORAL 20170711 ANDA ANDA091688 Exelan Pharmaceuticals Inc. TROSPIUM CHLORIDE 20 mg/1 Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 76282-340_3faf9403-ea78-48c3-a6a5-ab8b0b204b36 76282-340 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20160610 ANDA ANDA091305 Exelan Pharmaceuticals, Inc. NAPROXEN 250 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 76282-341_3faf9403-ea78-48c3-a6a5-ab8b0b204b36 76282-341 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20160610 ANDA ANDA091305 Exelan Pharmaceuticals, Inc. NAPROXEN 375 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 76282-342_3faf9403-ea78-48c3-a6a5-ab8b0b204b36 76282-342 HUMAN PRESCRIPTION DRUG Naproxen Naproxen TABLET ORAL 20160610 ANDA ANDA091305 Exelan Pharmaceuticals, Inc. NAPROXEN 500 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 76282-377_f055ad87-1683-4d1a-970f-e1b0ffaecb6e 76282-377 HUMAN PRESCRIPTION DRUG Calcium Acetate Calcium Acetate CAPSULE ORAL 20140414 ANDA ANDA203135 Exelan Pharmaceuticals, Inc. CALCIUM ACETATE 667 mg/1 Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 76282-405_58fe15a3-9d70-4310-a33d-6da58a5fcecd 76282-405 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 20121102 ANDA ANDA202764 Exelan Pharmaceuticals Inc. GABAPENTIN 600 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 76282-406_58fe15a3-9d70-4310-a33d-6da58a5fcecd 76282-406 HUMAN PRESCRIPTION DRUG GABAPENTIN gabapentin TABLET, FILM COATED ORAL 20121102 ANDA ANDA202764 Exelan Pharmaceuticals Inc. GABAPENTIN 800 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] N 20181231 76282-407_657621df-9c6b-4acf-a6a7-04628c529580 76282-407 HUMAN PRESCRIPTION DRUG Sevelamer carbonate SEVELAMER CARBONATE TABLET, FILM COATED ORAL 20171108 ANDA ANDA203860 Exelan Pharmaceuticals Inc. SEVELAMER CARBONATE 800 mg/1 Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 76282-412_8389b755-9dab-46e9-aefe-381f762bcc78 76282-412 HUMAN PRESCRIPTION DRUG Finasteride Finasteride TABLET, FILM COATED ORAL 20150522 ANDA ANDA090061 Exelan Pharmaceuticals Inc. FINASTERIDE 5 mg/1 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA] N 20181231 76282-417_baf4e41c-4613-4c1c-a21e-2c84f9e10b17 76282-417 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20170322 ANDA ANDA203508 Exelan Pharmaceuticals Inc. LISINOPRIL 2.5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-418_baf4e41c-4613-4c1c-a21e-2c84f9e10b17 76282-418 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20170322 ANDA ANDA203508 Exelan Pharmaceuticals Inc. LISINOPRIL 5 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-419_baf4e41c-4613-4c1c-a21e-2c84f9e10b17 76282-419 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20170322 ANDA ANDA203508 Exelan Pharmaceuticals Inc. LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-420_baf4e41c-4613-4c1c-a21e-2c84f9e10b17 76282-420 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20170322 ANDA ANDA203508 Exelan Pharmaceuticals Inc. LISINOPRIL 20 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-421_baf4e41c-4613-4c1c-a21e-2c84f9e10b17 76282-421 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20170322 ANDA ANDA203508 Exelan Pharmaceuticals Inc. LISINOPRIL 30 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-422_baf4e41c-4613-4c1c-a21e-2c84f9e10b17 76282-422 HUMAN PRESCRIPTION DRUG lisinopril lisinopril TABLET ORAL 20170322 ANDA ANDA203508 Exelan Pharmaceuticals Inc. LISINOPRIL 40 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76282-462_b57edfcd-c1a3-4b2f-90be-bf3b1c2ebdd9 76282-462 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20170606 ANDA ANDA204339 Exelan Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 5 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 76282-463_b57edfcd-c1a3-4b2f-90be-bf3b1c2ebdd9 76282-463 HUMAN PRESCRIPTION DRUG Rizatriptan Benzoate Rizatriptan Benzoate TABLET ORAL 20170606 ANDA ANDA204339 Exelan Pharmaceuticals Inc. RIZATRIPTAN BENZOATE 10 mg/1 Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] N 20181231 76282-481_fc0a2eec-c37c-4c24-8cdb-879834b60ef7 76282-481 HUMAN PRESCRIPTION DRUG Bupropion Hydrochloride (XL) bupropion hydrochloride TABLET, EXTENDED RELEASE ORAL 20170612 ANDA ANDA206556 Exelan Pharmaceuticals Inc. BUPROPION HYDROCHLORIDE 300 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 76282-628_8b7497d4-b363-448c-98f6-b58b94be9a42 76282-628 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM TABLET ORAL 20171110 ANDA ANDA077534 Exelan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 76282-629_8b7497d4-b363-448c-98f6-b58b94be9a42 76282-629 HUMAN PRESCRIPTION DRUG CITALOPRAM HYDROBROMIDE CITALOPRAM TABLET ORAL 20171110 ANDA ANDA077534 Exelan Pharmaceuticals Inc. CITALOPRAM HYDROBROMIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] N 20181231 76284-001_f0abfebd-a1bc-4b43-94f2-07acb3933173 76284-001 HUMAN OTC DRUG Alcohol Prep Pad ISOPROPYL ALCOHOL SWAB TOPICAL 20110627 OTC MONOGRAPH FINAL part344 Ningbo Timedo Medical Supply Co.,Ltd. ISOPROPYL ALCOHOL .7 mL/1 E 20171231 76284-002_cc74e6a6-caca-4cd2-8c35-bb3f803c26c0 76284-002 HUMAN OTC DRUG Alcohol Cotton Ball ISOPROPYL ALCOHOL SWAB TOPICAL 20110629 OTC MONOGRAPH FINAL part344 Ningbo Timedo Medical Supply Co.,Ltd. ISOPROPYL ALCOHOL .7 mL/1 E 20171231 76287-576_843a31ee-0551-48de-8b61-fdc84bc4bf87 76287-576 HUMAN OTC DRUG FresHands TRICLOSAN SOAP TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part333E Spa Concepts, Inc. TRICLOSAN 3 mg/mL E 20171231 76287-876_679b9fa9-d8f6-4e76-978e-0b06db8371f4 76287-876 HUMAN OTC DRUG FresHands Instant Foaming Antiseptic Hand and Body Wash CHLOROXYLENOL SOAP TOPICAL 20170104 OTC MONOGRAPH NOT FINAL part333E Spa Concepts, Inc. CHLOROXYLENOL 3 mg/mL N 20181231 76290-001_059763f6-72bd-4588-a239-88579c6d70e6 76290-001 HUMAN OTC DRUG Seven Skin Healing and Moisturizing Calendula officinalis CREAM TOPICAL 20111121 UNAPPROVED HOMEOPATHIC Robin Logan Consulting CALENDULA OFFICINALIS FLOWER 1.2 mL/60mL N 20181231 76293-015_dc185d05-bca1-465b-a06a-9247d36683b2 76293-015 HUMAN OTC DRUG Avail Body with Sunscreen Homosalate, Octocrylene, Octisalate, and Avobenzone LOTION TOPICAL 20141104 OTC MONOGRAPH FINAL part352 Emeis Cosmetics Pty Ltd HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE 3500; 2800; 1750; 1050 mg/35g; mg/35g; mg/35g; mg/35g N 20181231 76293-037_3a947dd1-5147-4c62-9b0c-8dc8b18f3fb4 76293-037 HUMAN OTC DRUG Sage And Zinc Facial Hydrating SPF 15 Zinc Oxide CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Emeis Cosmetics Pty Ltd ZINC OXIDE .26 g/1.54g N 20181231 76293-052_33cb261d-b49a-47d6-af07-2ad96fce14b9 76293-052 HUMAN OTC DRUG Avail Lip Balm with Sunscreen Zinc Oxide and Octocrylene STICK TOPICAL 20131201 OTC MONOGRAPH FINAL part352 Emeis Cosmetics Pty Ltd ZINC OXIDE; OCTOCRYLENE .00058; .00047 g/.011g; g/.011g N 20181231 76296-013_64432435-7032-09ba-e053-2991aa0aca13 76296-013 HUMAN OTC DRUG Vinoperfect Radiance Moisturizer Broad Spectrum SPF20 Avobenzone, Octinoxate, Octisalate, Octocrylene CREAM TOPICAL 20150402 20180228 OTC MONOGRAPH NOT FINAL part352 Caudalie USA Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 39.96; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 76296-014_6442e4e9-c7a4-8462-e053-2a91aa0a9496 76296-014 HUMAN OTC DRUG Caudalie Resveratrol Face Lifting Moisturizer Broad Spectrum SPF 20 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM TOPICAL 20150729 20180228 OTC MONOGRAPH NOT FINAL part352 Caudalie USA Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 30; 40; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL N 20191231 76297-001_a9f6e326-cb07-48fa-8c40-6ecc2bbfa332 76297-001 HUMAN PRESCRIPTION DRUG Sodium Chloride Sodium Chloride INJECTION, SOLUTION INTRAVENOUS 20170525 ANDA ANDA207956 LABORATORIOS GRIFOLS SA SODIUM CHLORIDE 9 g/1000mL N 20181231 76299-320_6d1f4c7a-2a78-4bb1-8413-7a404fea32ac 76299-320 HUMAN PRESCRIPTION DRUG Stendra avanafil TABLET ORAL 20131227 NDA NDA202276 Mist Pharmaceuticals, LLC AVANAFIL 50 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 76299-321_6d1f4c7a-2a78-4bb1-8413-7a404fea32ac 76299-321 HUMAN PRESCRIPTION DRUG Stendra avanafil TABLET ORAL 20131227 NDA NDA202276 Mist Pharmaceuticals, LLC AVANAFIL 100 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 76299-322_6d1f4c7a-2a78-4bb1-8413-7a404fea32ac 76299-322 HUMAN PRESCRIPTION DRUG Stendra avanafil TABLET ORAL 20131227 NDA NDA202276 Mist Pharmaceuticals, LLC AVANAFIL 200 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20191231 76299-420_f2055773-a120-415e-9758-7cf1751d3314 76299-420 HUMAN PRESCRIPTION DRUG INDERAL XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140201 20190531 NDA NDA021438 Mist Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 80 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 76299-422_f2055773-a120-415e-9758-7cf1751d3314 76299-422 HUMAN PRESCRIPTION DRUG INDERAL XL propranolol hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20140201 20190531 NDA NDA021438 Mist Pharmaceuticals, LLC PROPRANOLOL HYDROCHLORIDE 120 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 76299-430_f0f14f8e-5921-48f5-9bb8-c1f6a63a68c9 76299-430 HUMAN PRESCRIPTION DRUG NitroMist nitroglycerin AEROSOL, METERED SUBLINGUAL 20160125 NDA NDA021780 Mist Pharmaceuticals, LLC NITROGLYCERIN 400 ug/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 76305-300_d003e69b-358b-4021-a37b-4ed8e297d60b 76305-300 HUMAN OTC DRUG China-Gel Topical Pain Reliever Menthol and Camohor (synthetic) CREAM TOPICAL 20000819 OTC MONOGRAPH NOT FINAL part348 China-Gel, Inc. MENTHOL; CAMPHOR (SYNTHETIC) 50; 30 mg/g; mg/g N 20181231 76305-301_2667ee99-1173-50ee-e054-00144ff88e88 76305-301 HUMAN OTC DRUG China-Gel Topical Pain Reliever Menthol and Camohor (synthetic) CREAM TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part348 China-Gel, Inc. MENTHOL; CAMPHOR (SYNTHETIC) 50; 30 mg/g; mg/g N 20181231 76305-401_2b4da9de-b3f0-4067-e054-00144ff88e88 76305-401 HUMAN OTC DRUG Jivamukti Camphor,Menthol CREAM TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part348 China-Gel, Inc. MENTHOL; CAMPHOR (NATURAL) 5; 3 g/100g; g/100g E 20171231 76308-001_e2106329-5ca2-4274-9fe4-46e888ee08f8 76308-001 HUMAN OTC DRUG Hand Sanitizer ETHANOL GEL TOPICAL 20110905 OTC MONOGRAPH NOT FINAL part333E Just Play, LLC ALCOHOL 600 mL/1000mL E 20171231 76310-002_5a881549-9d86-4ff7-b4ab-2cfb315f9af3 76310-002 HUMAN PRESCRIPTION DRUG Cardioxane dexrazoxane INJECTION, POWDER, FOR SOLUTION INTRAVENOUS 20170728 UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE Clinigen Healthcare Ltd DEXRAZOXANE HYDROCHLORIDE 500 mg/1 Cytoprotective Agent [EPC] N 20181231 76310-024_00ca4075-719d-4657-82f4-423d7ac5b148 76310-024 HUMAN PRESCRIPTION DRUG Foscavir foscarnet sodium INJECTION, SOLUTION INTRAVENOUS 20140401 NDA NDA020068 Clinigen Healthcare Ltd. FOSCARNET SODIUM 24 mg/mL DNA Polymerase Inhibitors [MoA],Pyrophosphate Analog [Chemical/Ingredient],Pyrophosphate Analog DNA Polymerase Inhibitor [EPC],Chelating Activity [MoA] N 20181231 76310-024_6ef339af-be8b-4b3d-9075-87627d254f44 76310-024 HUMAN PRESCRIPTION DRUG Foscavir foscarnet sodium INJECTION, SOLUTION INTRAVENOUS 20120709 NDA NDA020068 Clinigen Healthcare Ltd. FOSCARNET SODIUM 24 mg/mL DNA Polymerase Inhibitors [MoA],Pyrophosphate Analog [Chemical/Ingredient],Pyrophosphate Analog DNA Polymerase Inhibitor [EPC],Chelating Activity [MoA] N 20181231 76312-001_ac9efe9d-e07c-41ad-9139-471cc18154e0 76312-001 HUMAN OTC DRUG TriCalm Hydrogel Aluminum Acetate GEL TOPICAL 20131101 OTC MONOGRAPH FINAL part347 Cosmederm Bioscience ALUMINUM ACETATE 2 mg/mL E 20171231 76312-002_af5bb865-96b4-4654-acd9-a2de73895476 76312-002 HUMAN OTC DRUG TriCalm Extra Strength Aluminum Acetate SOLUTION TOPICAL 20150301 OTC MONOGRAPH FINAL part347 Cosmederm Bioscience ALUMINUM ACETATE 3 mg/mL E 20171231 76314-002_2e04c3e7-8cec-40a9-e054-00144ff8d46c 76314-002 HUMAN OTC DRUG FixMySkin Healing Balm Fragrance-Free HYDROCORTISONE OINTMENT TOPICAL 20111117 OTC MONOGRAPH NOT FINAL part348 Lovely Skin, Inc. HYDROCORTISONE 10 mg/mL N 20181231 76314-003_ae2d43f9-3f1c-4b03-9978-bc77545c7be7 76314-003 HUMAN OTC DRUG FixMySkin Healing Balm Unflavored HYDROCORTISONE OINTMENT TOPICAL 20111117 OTC MONOGRAPH FINAL part348 Lovely Skin, Inc. HYDROCORTISONE 1 mL/100mL N 20181231 76314-004_df20bfb1-659e-4896-bfb2-e478f8ae6ecb 76314-004 HUMAN OTC DRUG FixMySkin Healing Balm Vanilla Flavor HYDROCORTISONE OINTMENT TOPICAL 20111117 OTC MONOGRAPH FINAL part348 Lovely Skin, Inc. HYDROCORTISONE 1 mL/100mL N 20181231 76315-1017_fcc70f63-574a-4d82-9f88-b5bf59a1a191 76315-1017 HUMAN OTC DRUG FRESH FOAM DISINFECTANT Foaming Hand Sanitizer AEROSOL, FOAM TOPICAL 20180101 OTC MONOGRAPH NOT FINAL part333E DeVere Company, Inc. CHLOROXYLENOL; ISOPROPYL ALCOHOL 4; 10 g/L; g/L N 20191231 76315-1052_85d94f84-bb86-48a6-aac2-5a981764f77f 76315-1052 HUMAN OTC DRUG Bac-Off Foaming Hand Sanitizer AEROSOL, FOAM TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333E DeVere Company, Inc. BENZALKONIUM CHLORIDE 100 g/100L E 20171231 76318-334_7ef85853-008b-4dab-a4d8-d10e5bcb1fec 76318-334 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20111030 ANDA ANDA204333 Massachusetts General Hospital FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 76318-643_4f6fd8ea-3896-4106-9264-aac973a21b63 76318-643 HUMAN PRESCRIPTION DRUG Ammonia N 13 ammonia n-13 INJECTION, SOLUTION INTRAVENOUS 20160203 ANDA ANDA207025 Massachusetts General Hospital AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 76326-001_ea1acde6-468c-492c-b343-1841f95364dc 76326-001 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F18 Fludeoxyglucose F18 INJECTION INTRAVENOUS 20120612 ANDA ANDA204531 The Regents of the University of Michigan FLUDEOXYGLUCOSE F-18 300 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] E 20171231 76328-100_7c50a663-7866-40c9-a293-7d4a0cc12153 76328-100 HUMAN OTC DRUG Ancient Secrets Breathe Again Sodium Chloride AEROSOL, SPRAY NASAL 20110815 OTC MONOGRAPH FINAL part349 LOTUS BRANDS, INC. SODIUM CHLORIDE 20 mg/100mL N 20181231 76328-101_879336d3-14c7-45dd-9b92-c02c4fecb542 76328-101 HUMAN OTC DRUG Ancient Secrets Breathe Again Childrens Sodium Chloride AEROSOL, SPRAY NASAL 20110815 OTC MONOGRAPH FINAL part349 LOTUS BRANDS, INC. SODIUM CHLORIDE 20 mg/100mL N 20181231 76328-221_22e86631-5490-4842-9d75-48e7b511accd 76328-221 HUMAN OTC DRUG EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon SODIUM BICARBONATE LIQUID ORAL 20130601 OTC MONOGRAPH NOT FINAL part356 Lotus Brands, Inc. SODIUM BICARBONATE 25 mg/mL E 20171231 76328-222_2236e496-e8e4-4185-8fc6-193fe92fcbc8 76328-222 HUMAN OTC DRUG EcoDent Res-Q-Dent Potassium Nitrate PASTE ORAL 20130601 OTC MONOGRAPH NOT FINAL part356 Lotus Brands, Inc. POTASSIUM NITRATE 50 mg/g E 20171231 76328-223_52dd9942-cdea-483f-9f23-028d3bc2f7ad 76328-223 HUMAN OTC DRUG EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint SODIUM BICARBONATE LIQUID ORAL 20130601 OTC MONOGRAPH NOT FINAL part356 Lotus Brands, Inc. SODIUM BICARBONATE 25 mg/mL E 20171231 76328-332_978ed130-1e60-4a98-a64f-ac2530eebeca 76328-332 HUMAN OTC DRUG Beauty Without Cruelty - Broad Spectrum SPF 30 ZINC OXIDE LOTION TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Lotus Brands, Inc. ZINC OXIDE 200 mg/mL E 20171231 76328-333_b7db9261-84b7-48fa-9ed8-64af6fbd7ede 76328-333 HUMAN OTC DRUG Beauty Without Cruelty - Broad Spectrum SPF 18 OCTISALATE, AVOBENZONE, and OCTOCRYLENE LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Lotus Brands, Inc. OCTISALATE; AVOBENZONE; OCTOCRYLENE 50; 25; 50 mg/mL; mg/mL; mg/mL E 20171231 76328-334_76092920-80c6-4cf1-ad8b-856b55755768 76328-334 HUMAN OTC DRUG Beauty Without Cruelty - Broad Spectrum SPF 17 Vitamin C with CoQ10 ZINC OXIDE LOTION TOPICAL 20130601 OTC MONOGRAPH FINAL part352 Lotus Brands, Inc. ZINC OXIDE 140 mg/mL E 20171231 76329-1240_fb4c6813-0fb5-4555-867b-76929ae62bdb 76329-1240 HUMAN PRESCRIPTION DRUG Phytonadione Phytonadione INJECTION, EMULSION PARENTERAL 20030418 ANDA ANDA083722 International Medication Systems, Limited PHYTONADIONE 1 mg/.5mL Increased Prothrombin Activity [PE],Reversed Anticoagulation Activity [PE],Vitamin K [Chemical/Ingredient],Vitamin K [EPC],Warfarin Reversal Agent [EPC] N 20181231 76329-1469_50eb27d5-c026-439a-98a2-ae1601298ff0 76329-1469 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 19880401 ANDA ANDA072076 International Medication Systems, Limited NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 76329-1911_41d1599a-3754-4a10-b1f3-f9976614ab98 76329-1911 HUMAN PRESCRIPTION DRUG Morphine Sulfate Morphine Sulfate INJECTION INTRAVENOUS 19870327 UNAPPROVED DRUG OTHER International Medication Systems, Limited MORPHINE SULFATE 1 mg/mL Full Opioid Agonists [MoA],Opioid Agonist [EPC] CII N 20181231 76329-3011_7a0d5da9-4535-4da5-88f2-1f54cce48e71 76329-3011 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 International Medication Systems, Limited LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76329-3012_7a0d5da9-4535-4da5-88f2-1f54cce48e71 76329-3012 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 International Medication Systems, Limited LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76329-3013_7a0d5da9-4535-4da5-88f2-1f54cce48e71 76329-3013 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 International Medication Systems, Limited LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76329-3015_7a0d5da9-4535-4da5-88f2-1f54cce48e71 76329-3015 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride JELLY TOPICAL 19790807 ANDA ANDA086283 International Medication Systems, Limited LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76329-3301_872f0955-2da1-49c0-8b21-8f48115ef533 76329-3301 HUMAN PRESCRIPTION DRUG Dextrose Monohydrate Dextrose Monohydrate INJECTION PARENTERAL 20000601 UNAPPROVED DRUG OTHER International Medication Systems, Limited DEXTROSE MONOHYDRATE 500 mg/mL N 20181231 76329-3304_bcb9af72-43bf-4700-8e71-ffb1c8716666 76329-3304 HUMAN PRESCRIPTION DRUG Calcium Chloride Calcium Chloride INJECTION INTRAVENOUS; INTRAVENTRICULAR 19730501 UNAPPROVED DRUG OTHER International Medication Systems, Limited CALCIUM CHLORIDE 100 mg/mL Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 76329-3316_9b7d7e7f-6c09-4576-aa5a-db998dbd24f7 76329-3316 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION INTRACARDIAC; INTRAVENOUS 19761201 UNAPPROVED DRUG OTHER International Medication Systems, Limited EPINEPHRINE .1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 76329-3339_3b5aa53c-bf76-4c59-9be6-2a7eb4f0211b 76329-3339 HUMAN PRESCRIPTION DRUG Atropine Sulfate Atropine Sulfate INJECTION PARENTERAL 20000601 UNAPPROVED DRUG OTHER International Medication Systems, Limited ATROPINE SULFATE .1 mg/mL Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA] N 20181231 76329-3352_0e955d36-928c-4f09-9b34-0cc954e5b1f4 76329-3352 HUMAN PRESCRIPTION DRUG Sodium Bicarbonate Sodium Bicarbonate INJECTION INTRAVENOUS 20000601 ANDA ANDA203449 International Medication Systems, Limited SODIUM BICARBONATE 84 mg/mL N 20181231 76329-3369_50eb27d5-c026-439a-98a2-ae1601298ff0 76329-3369 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 20010601 ANDA ANDA072076 International Medication Systems, Limited NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 76329-3390_4eb41a1c-dfa0-41ff-b506-3ef0c0f2e3ac 76329-3390 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride INJECTION INTRAVENOUS 20010601 ANDA ANDA083173 International Medication Systems, Limited LIDOCAINE HYDROCHLORIDE 20 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76329-3399_f3adde99-01db-4dee-a59d-9434cbb88495 76329-3399 HUMAN PRESCRIPTION DRUG Procainamide Hydrochloride Procainamide Hydrochloride INJECTION INTRAMUSCULAR; INTRAVENOUS 20161221 ANDA ANDA088636 International Medication Systems, Limited PROCAINAMIDE HYDROCHLORIDE 100 mg/mL Antiarrhythmic [EPC] N 20181231 76329-3469_77de41e6-9b6c-4052-982f-631f8ebf98d8 76329-3469 HUMAN PRESCRIPTION DRUG Naloxone Hydrochloride Naloxone Hydrochloride INJECTION PARENTERAL 20160728 ANDA ANDA072076 International Medication Systems, Limited NALOXONE HYDROCHLORIDE 1 mg/mL Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 76329-6300_7e7dc900-7309-4d30-83e4-e76c971ef7e5 76329-6300 HUMAN PRESCRIPTION DRUG Lidocaine Hydrochloride Lidocaine Hydrochloride SOLUTION TOPICAL 20120619 ANDA ANDA086364 International Medication Systems, Limited LIDOCAINE HYDROCHLORIDE 40 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76329-8261_f2099b7d-0272-41bd-9ab6-c8c79074c294 76329-8261 HUMAN PRESCRIPTION DRUG Lorazepam Lorazepam INJECTION INTRAMUSCULAR; INTRAVENOUS 20121201 ANDA ANDA076150 International Medication Systems, Limited LORAZEPAM 2 mg/mL Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient] N 20181231 76329-9061_edc20184-1d8a-46a6-8c99-4680d39a5fca 76329-9061 HUMAN PRESCRIPTION DRUG Epinephrine Epinephrine INJECTION PARENTERAL 20000701 UNAPPROVED DRUG OTHER International Medication Systems, Limited EPINEPHRINE 1 mg/mL Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient] N 20181231 76330-100_eef48335-b1b4-431c-8c73-09171d9eba10 76330-100 HUMAN OTC DRUG Bum Ease Zinc Oxide LIQUID TOPICAL 20110701 OTC MONOGRAPH FINAL part347 Wake Innovation, LLC ZINC OXIDE 10 g/100mL E 20171231 76331-900_4f619836-f77d-433a-b8db-2a08b6e3fdde 76331-900 HUMAN PRESCRIPTION DRUG HEMETAB FOLIC ACID, CYANOCOBALAMIN, IRON SUCROSE, HEME IRON POLYPEPTIDE TABLET ORAL 20120501 UNAPPROVED DRUG OTHER WH Nutritionals, LLC FOLIC ACID; CYANOCOBALAMIN; IRON SUCROSE; HEME IRON POLYPEPTIDE 1; 25; 22; 6 mg/1; ug/1; mg/1; mg/1 Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 76331-901_0ac91e69-55af-47da-a726-6657cba05a1e 76331-901 HUMAN PRESCRIPTION DRUG HemeNatal OB CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL SUCCINATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, IRON SUCROSE, HEME IRON POLYPEPTIDE, POTASSIUM IODIDE, ZINC OXIDE, SODIUM SELENATE, CUPRIC SULFATE TABLET ORAL 20120308 UNAPPROVED DRUG OTHER WH Nutritionals, LLC CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL SUCCINATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; IRON SUCROSE; HEME IRON POLYPEPTIDE; POTASSIUM IODIDE; ZINC OXIDE; SODIUM SELENATE; CUPRIC SULFATE 400; 10; 1.5; 1.6; 17; 50; 1; 12; 30; 10; 28; 6; 250; 4.5; 65; .8 [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1 Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] N 20181231 76331-904_6f065bf4-8aca-43e8-b951-8036fe5fcb12 76331-904 HUMAN PRESCRIPTION DRUG HemeNatal OB plus DHA CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL SUCCINATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, IRON SUCROSE, HEME IRON POLYPEPTIDE, POTASSIUM IODIDE, ZINC OXIDE, SODIUM SELENATE, CUPRIC SULFATE, DOCONEXENT, LINOLENIC ACID, OSBOND ACID KIT 20120308 UNAPPROVED DRUG OTHER WH Nutritionals, LLC N 20181231 76331-905_8b17d2c3-f799-4d42-85c3-bd79695487bd 76331-905 HUMAN PRESCRIPTION DRUG Nutri-Tab OB SODIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM FORMATE, CALCIUM CARBONATE, FERROUS BISGLYCINATE, POTASSIUM IODIDE, ZINC OXIDE, CHOLINE BITARTRATE TABLET ORAL 20120503 UNAPPROVED DRUG OTHER WH Nutritionals, LLC SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM FORMATE; CALCIUM CARBONATE; FERROUS BISGLYCINATE; POTASSIUM IODIDE; ZINC OXIDE; CHOLINE BITARTRATE 120; 450; 30; 3; 3; 20; 50; 1000; 10; 155; 45; 32; 100; 10; 55 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] N 20181231 76331-908_63070a7f-f5d7-4a19-a68e-a5aea95e5db9 76331-908 HUMAN PRESCRIPTION DRUG Nutri-Tab OB plus DHA SODIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM FORMATE, CALCIUM CARBONATE, FERROUS BISGLYCINATE, POTASSIUM IODIDE, ZINC OXIDE, CHOLINE BITARTRATE, DOCONEXENT, ICOSAPENT KIT 20120503 UNAPPROVED DRUG OTHER WH Nutritionals, LLC N 20181231 76333-125_71fe01c0-610b-477e-8709-d194ebde8624 76333-125 HUMAN PRESCRIPTION DRUG Miglitol Miglitol TABLET, COATED ORAL 20150731 ANDA ANDA203965 Orient Pharma Co., Ltd. MIGLITOL 25 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] E 20171231 76333-126_71fe01c0-610b-477e-8709-d194ebde8624 76333-126 HUMAN PRESCRIPTION DRUG Miglitol Miglitol TABLET, COATED ORAL 20150731 ANDA ANDA203965 Orient Pharma Co., Ltd. MIGLITOL 50 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] E 20171231 76333-127_71fe01c0-610b-477e-8709-d194ebde8624 76333-127 HUMAN PRESCRIPTION DRUG Miglitol Miglitol TABLET, COATED ORAL 20150731 ANDA ANDA203965 Orient Pharma Co., Ltd. MIGLITOL 100 mg/1 alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] E 20171231 76333-135_8e0acb33-d192-4d19-9011-79a508d1d524 76333-135 HUMAN PRESCRIPTION DRUG Carisoprodol Carisoprodol TABLET ORAL 20150601 ANDA ANDA205085 Orient Pharma Co., Ltd. CARISOPRODOL 350 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 76334-001_d2bd802d-8b2a-45a9-bbd5-62df04fe1436 76334-001 HUMAN OTC DRUG PEN Prep MAGNESIUM CITRATE POWDER, FOR SOLUTION ORAL 20100701 OTC MONOGRAPH FINAL part331 PEN Prep LLC MAGNESIUM CITRATE 17 g/100g E 20171231 76334-002_411ab635-a095-416a-b679-e0b4c4e3dcf8 76334-002 HUMAN OTC DRUG PEN Prep Plus MAGNESIUM CITRATE POWDER, FOR SOLUTION ORAL 20100701 OTC MONOGRAPH FINAL part331 PEN Prep LLC MAGNESIUM CITRATE; DIMETHICONE 17; .08 g/100g; g/100g E 20171231 76335-001_c23fba7e-a958-4412-933b-6782485cab43 76335-001 HUMAN OTC DRUG Energy Enhancer Alfalfa, Ambra Grisea, Anacardium Orientale, Argenticum Nitricum, Aurum Metallicum, Avena Sativa, Caladium Seguinum, Calcarea Carbonica, Cocculus Indicus, Gelsemium, Ignatia Amara, Kali Phosphoricum, Lycopodium, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Selenium, Sepia, Silicea, Sulphur PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. ALFALFA; AMBERGRIS; SEMECARPUS ANACARDIUM JUICE; SILVER NITRATE; GOLD; AVENA SATIVA FLOWERING TOP; DIEFFENBACHIA SEGUINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANAMIRTA COCCULUS SEED; GELSEMIUM SEMPERVIRENS ROOT; STRYCHNOS IGNATII SEED; POTASSIUM PHOSPHATE, DIBASIC; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SULFUR 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 76335-002_81b051a9-c820-4ecf-a85e-a53d6c398797 76335-002 HUMAN OTC DRUG Silent Nights Aconitum Napellus, Arsenicum Album, Avena Sativa, Belladonna, Camphora, Cinchona Officinalis, Coffea Cruda, Cypripedium Pubescens, Hyoscyamus Niger, Passiflora Incarnata, Pulsatilla, Valeriana Officinalis PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BELLADONNA LEAF; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA FLOWER; PULSATILLA VULGARIS; VALERIAN 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 76335-003_ad893816-b204-4661-8ad3-009d6bda7d8c 76335-003 HUMAN OTC DRUG SP6 Complete Abies Canadensis, Ammonium Bromatum, Ammonium Muriaticum, Anaradium Orientale, Antimonium Crudum, Argentum Metallicum, Calcarea Carbonica, Capsicum, Cinchona, Ferrum Metallicum, Fucus, Ignatia, Kali Bichromicum, Natrum Sulphuricum, Oleander, Phosphorus, Phytolacca, Sabadilla, Staphysagria, Sulphur, Thyroidinum, Veratrum Album PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. TSUGA CANADENSIS BARK; AMMONIUM BROMIDE; AMMONIUM CHLORIDE; SEMECARPUS ANACARDIUM JUICE; ANTIMONY TRISULFIDE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CINCHONA OFFICINALIS BARK; IRON; FUCUS VESICULOSUS; STRYCHNOS IGNATII SEED; POTASSIUM DICHROMATE; SODIUM SULFATE; NERIUM OLEANDER LEAF; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SCHOENOCAULON OFFICINALE SEED; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THYROID, UNSPECIFIED; VERATRUM ALBUM ROOT 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 76335-004_8feec555-4603-4521-9528-0520259fa8d9 76335-004 HUMAN OTC DRUG Y-Age Carnosine Abrotanum, Anacardium, Arsenicum Album, Baryta Carbonica, Baryta Muriatium, Calcarea Carbonica, Calcarea Flourica, Calcarea Phosphorica, Ferrum Metallicum, Fucus Vesiculosus, Hekla, Helleborus Niger, Ignatia Amara, Lycopodium, Nicotinamidum, Secale, Silicea PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; SILVER; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; STRYCHNOS IGNATII SEED; HEKLA LAVA; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 76335-005_72fea124-d288-4687-abae-76846f07c9cf 76335-005 HUMAN OTC DRUG Y-age AEON Aconitum Napellus, Arsenicum Album, Bryonia Alba, Baryta Carbonica, Calcarea Carbonica, Cantharis, Gelsemium Sempervirens, Graphites, Hydrastis Canadensis, Kali Iodatum, Lachesis Mutus, Lycopodium Clavatum, Mercurius Vivus, Natrum Muriaticum, Nux Vomica, Phosphorus, Phytolacca Decandra, Pulsatilla, Rhus Toxicodendron, Sepia, Silicea, Sulphur PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. ACONITUM NAPELLUS; ARSENIC TRIOXIDE; SULFUR; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GELSEMIUM SEMPERVIRENS ROOT; GRAPHITE; GOLDENSEAL; POTASSIUM IODIDE; LACHESIS MUTA VENOM; MERCURY; SODIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SILICON DIOXIDE; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SEPIA OFFICINALIS JUICE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 76335-006_dfea59ca-3ce8-45c1-a068-d7c85457f74d 76335-006 HUMAN OTC DRUG Icewave Actaea, Aesculus Hipp, Arnica, Bellis, Bryonia, Calc Carb, Calc Fluor, Causticum, Cimicifuga, Formicum Acidum, Hypericum, Ledum, Lithium Carb, Mag Phos, Phosphorus, Phytolacca Decandra, Pulsatilla, Rhododendron, Rhus Tox, Ruta, Salicylicum Acidum, Sepia, Zinc Metallicum PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. ACTAEA SPICATA ROOT; AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALCIUM FLUORIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; BLACK COHOSH; FORMIC ACID; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE; PHOSPHORUS; PULSATILLA VULGARIS; PHYTOLACCA AMERICANA ROOT; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; SEPIA OFFICINALIS JUICE; ZINC 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 76335-007_6400df76-6838-4b86-871c-ae68e43f1a89 76335-007 HUMAN OTC DRUG Y-Age Glutathione Abrotanum, Anacardium, Arsenicum Alb, Baryta Carb, Baryta Mur, Calc Carb, Calc Fluor, Calc Phos, Ferrum Met, Fucus, Hekla, Hellbor Nig, Ignatia, Lycopodium, Nicotinamidum, Secale, Silicea PATCH TOPICAL 20091231 UNAPPROVED HOMEOPATHIC Lifewave, Inc. ARTEMISIA ABROTANUM FLOWERING TOP; SEMECARPUS ANACARDIUM JUICE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BARIUM CHLORIDE DIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CALCIUM FLUORIDE; CALCIUM PHOSPHATE; IRON; FUCUS VESICULOSUS; STRYCHNOS IGNATII SEED; HEKLA LAVA; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; NIACINAMIDE; CLAVICEPS PURPUREA SCLEROTIUM; SILICON DIOXIDE 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 N 20181231 76336-455_872505e9-b166-409b-9f77-4d790bc275d8 76336-455 HUMAN PRESCRIPTION DRUG Metopirone Metyrapone CAPSULE, GELATIN COATED ORAL 20140814 NDA NDA012911 Laboratoire HRA Pharma METYRAPONE 250 mg/1 Adrenal Steroid Synthesis Inhibitor [EPC],Adrenal Steroid Synthesis Inhibitors [MoA] N 20181231 76340-1001_8bf094ed-d730-445e-a5ae-8c65ac55ec9b 76340-1001 HUMAN OTC DRUG YS Solution Ac control Skin Regular Mild salicylic acid LIQUID TOPICAL 20110810 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd SALICYLIC ACID .47 mL/100mL E 20171231 76340-1101_e331d4c1-599f-4c21-8a10-e5d7626425af 76340-1101 HUMAN OTC DRUG YS Solution Intensive AC Care salicylic acid GEL TOPICAL 20110810 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd SALICYLIC ACID .47 mL/100mL E 20171231 76340-1201_6304bca3-e484-c11c-e053-2a91aa0a0dee 76340-1201 HUMAN OTC DRUG Dr. Eslee Physical Sunscreen Zinc oxide CREAM TOPICAL 20130628 OTC MONOGRAPH FINAL part347 Ajou Medics Co., Ltd ZINC OXIDE .01248 g/g N 20191231 76340-1301_6304bca3-e491-c11c-e053-2a91aa0a0dee 76340-1301 HUMAN OTC DRUG Dr.eslee Intensive Recovery Blemish Balm Zinc oxide CREAM TOPICAL 20140723 OTC MONOGRAPH FINAL part347 Ajou Medics Co., Ltd ZINC OXIDE .01248 g/g N 20191231 76340-1401_5c055e35-2137-65e5-e053-2991aa0ae926 76340-1401 HUMAN OTC DRUG Dr. eslee Intensive Care salicylic acid GEL TOPICAL 20171021 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd. SALICYLIC ACID .1 g/100mL N 20181231 76340-1501_5c06cd66-5512-02d5-e053-2a91aa0aa74f 76340-1501 HUMAN OTC DRUG Dr. eslee Intensive Recovery Blemish Balm titanium dioxide CREAM TOPICAL 20171021 OTC MONOGRAPH FINAL part352 Ajou Medics Co., Ltd. TITANIUM DIOXIDE 10.08 g/100g N 20181231 76340-2001_1fa11bd2-9f9e-4f2f-9046-615f8db02a0f 76340-2001 HUMAN OTC DRUG YS Solution Ac Care salicylic acid CREAM TOPICAL 20110810 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd SALICYLIC ACID .47 mL/100mL E 20171231 76340-3001_6304bca3-e4a5-c11c-e053-2a91aa0a0dee 76340-3001 HUMAN OTC DRUG Dr.eslee Sun Matte OCTINOXATE LIQUID TOPICAL 20110810 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd OCTINOXATE 7.5 g/100g N 20191231 76340-4001_8193343f-408d-41ac-80b1-e3ceca18c791 76340-4001 HUMAN OTC DRUG Dr.eslee Sun Protection OCTINOXATE CREAM TOPICAL 20110810 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd OCTINOXATE 7 g/100g E 20171231 76340-5001_a9970e98-7bad-4f2e-b25f-0f60ca838dcb 76340-5001 HUMAN OTC DRUG Dr.eslee Skin Mild salicylic acid LIQUID TOPICAL 20110810 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd SALICYLIC ACID .48 mL/100mL E 20171231 76340-6001_93559658-a3bb-4b6b-9aa6-3aee6f8690ad 76340-6001 HUMAN OTC DRUG Dr.eslee Triple Action BB ADENOSINE CREAM TOPICAL 20110913 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd ADENOSINE .2 g/100g E 20171231 76340-7001_943d8c5d-db3a-4a7c-9182-f930594d0959 76340-7001 HUMAN OTC DRUG Bellaskin Brightening Contour Essence NIACINAMIDE CREAM TOPICAL 20110913 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd NIACINAMIDE 2 mL/100mL E 20171231 76340-8001_aea72323-c81e-44db-847b-96e6b3948ed2 76340-8001 HUMAN OTC DRUG Bellaskin Skin-rebirth Contour ADENOSINE CREAM TOPICAL 20110913 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd ADENOSINE .04 mL/100mL E 20171231 76340-9001_9bf31400-7baf-46b0-afb8-434c8289a396 76340-9001 HUMAN OTC DRUG YS Solution Ac control Skin Regular Mild salicylic acid LIQUID TOPICAL 20111025 UNAPPROVED DRUG OTHER Ajou Medics Co., Ltd SALICYLIC ACID .47 mL/100mL E 20171231 76341-696_d5eb1bb1-0922-45ce-842c-ee0b33704f06 76341-696 HUMAN OTC DRUG Clear Eyes Maximum Redness Relief naphazoline hydrochloride and glycerin LIQUID OPHTHALMIC 20170628 OTC MONOGRAPH FINAL part349 Pillar5 Pharma, Inc. GLYCERIN; NAPHAZOLINE HYDROCHLORIDE 5; .3 mg/mL; mg/mL N 20181231 76341-797_1a6b7ce3-fa02-4bb1-9139-dc431395cde1 76341-797 HUMAN OTC DRUG Clear Eyes Redness Relief naphazoline hydrochloride and glycerin LIQUID OPHTHALMIC 20170619 OTC MONOGRAPH FINAL part349 Pillar5 Pharma, Inc. GLYCERIN; NAPHAZOLINE HYDROCHLORIDE 2.5; .12 mg/mL; mg/mL N 20181231 76341-999_dc893718-c4ab-4dc5-af76-f2eedff48ef0 76341-999 HUMAN OTC DRUG Clear Eyes Maximum Itchy Eye Relief glycerin, naphazoline hydrochloride, and zinc sulfate LIQUID OPHTHALMIC 20170828 OTC MONOGRAPH FINAL part349 Pillar5 Pharma, Inc. GLYCERIN; NAPHAZOLINE HYDROCHLORIDE; ZINC SULFATE, UNSPECIFIED FORM 2.5; .12; 2.5 mg/mL; mg/mL; mg/mL N 20181231 76344-0101_30dd3283-f239-436c-e054-00144ff8d46c 76344-0101 HUMAN OTC DRUG ANESTA LIDOCAINE CREAM TOPICAL 20160101 OTC MONOGRAPH FINAL part346 Humex,Inc. LIDOCAINE 5 g/100g N 20181231 76344-0102_30dd3283-f244-436c-e054-00144ff8d46c 76344-0102 HUMAN OTC DRUG ANESTA LIDOCAINE CREAM TOPICAL 20160101 OTC MONOGRAPH FINAL part346 Humex,Inc. LIDOCAINE 5 g/100g N 20181231 76344-1101_1c73e14c-3ebe-4842-a3ad-94c6bd274219 76344-1101 HUMAN OTC DRUG Age Defense Snail BB Cream Titanium Dioxide, Octinoxate, Zinc Oxide CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Humex,Inc. TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE 7.92; 3; 1.92 g/100mL; g/100mL; g/100mL N 20181231 76344-1102_db4a6fa5-a9da-48b5-a22a-2ba98968fa98 76344-1102 HUMAN OTC DRUG Miracle Matt BB Cream TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Humex,Inc. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 7.18; 2; 2; 1.92 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76344-1103_83fae46a-b3de-4ccb-9fd6-45ec370b1a2e 76344-1103 HUMAN OTC DRUG TS CC Cream Natural Beige TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Humex,Inc. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 6.35; 6; 2; 1.92 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76344-1104_e06e16d3-b058-4cfa-a37d-d56ddc984722 76344-1104 HUMAN OTC DRUG TS CC Cream Beige TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM TOPICAL 20150801 OTC MONOGRAPH NOT FINAL part352 Humex,Inc. TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE; ZINC OXIDE 6.35; 6; 2; 1.92 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76344-8001_54dbdbc2-cda4-17cf-e054-00144ff8d46c 76344-8001 HUMAN OTC DRUG Laser Sunscreen 100 OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM TOPICAL 20140101 OTC MONOGRAPH FINAL part352 Humex,Inc. OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE 7.5; 5; 4.8; 2.49 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76345-8179_fc79c87a-9714-44d1-b93c-bded4e9149d7 76345-8179 HUMAN OTC DRUG Nurigene Nourishing Daytime SPF 15 Octinoxate, Octisalate, Oxybenzone LOTION TOPICAL 20110815 OTC MONOGRAPH FINAL part352 Peninsula Skincare Labs Inc OCTINOXATE; OCTISALATE; OXYBENZONE 75; 45; 30 mg/mL; mg/mL; mg/mL N 20181231 76346-073_a7a82d01-b8da-45f4-ae11-bcf344c6cdd9 76346-073 HUMAN PRESCRIPTION DRUG Korlym Mifepristone TABLET ORAL 20120217 NDA NDA202107 Corcept Therapeutics Inc MIFEPRISTONE 300 mg/1 Progestational Hormone Receptor Antagonists [MoA],Progestin Antagonist [EPC] N 20181231 76347-120_12069c64-ceed-44ac-a283-ee64cbe4a25a 76347-120 HUMAN OTC DRUG Foot Rehab Pain relief and moisturizer Mission Menthol, Methyl Salicylate CREAM TOPICAL 20121105 OTC MONOGRAPH NOT FINAL part348 Mission Product Holdings MENTHOL; METHYL SALICYLATE 8.5; 12.75 g/85g; g/85g E 20171231 76347-125_0a3a1775-46a6-4d6c-a6e9-c0122165240f 76347-125 HUMAN OTC DRUG Anti-Chafe Stick Pro Series Allantoin STICK TOPICAL 20110726 OTC MONOGRAPH FINAL part347 Mission Product Holdings ALLANTOIN .5 g/100g E 20171231 76347-126_1f873653-30e1-4cfd-9f45-37c0a86382db 76347-126 HUMAN OTC DRUG Blister Armour Anti-Friction Mission Allantoin STICK TOPICAL 20110726 OTC MONOGRAPH FINAL part347 Mission Product Holdings ALLANTOIN .5 g/100g E 20171231 76348-401_6a7d5d56-5941-4ef3-8a7c-de7c276dfb91 76348-401 HUMAN OTC DRUG Molecular AF Tolnaftate OIL TOPICAL 20110701 OTC MONOGRAPH FINAL part333C Renu Laboratories, Inc. TOLNAFTATE .01 mg/mL E 20171231 76348-402_129abc26-057d-6e7b-e054-00144ff8d46c 76348-402 HUMAN OTC DRUG Molecular AF Molecular Cream Molecular AF Molecular Cream CREAM TOPICAL 20150331 OTC MONOGRAPH FINAL part333C Renu Laboratories, Inc. MICONAZOLE NITRATE .3 g/14g E 20171231 76348-405_13b1801d-0d47-738c-e054-00144ff88e88 76348-405 HUMAN OTC DRUG Renu Laboratories Drying Acne Drying Lotion SUSPENSION TOPICAL 20150406 OTC MONOGRAPH FINAL part333D Renu Laboratories, Inc. SULFUR 1.4 g/14g E 20171231 76348-406_143fa2b7-633c-67ed-e054-00144ff88e88 76348-406 HUMAN OTC DRUG Renu Laboratories Acne Sulphur L Acne Sulfur Lotion SUSPENSION TOPICAL 20150416 OTC MONOGRAPH FINAL part333D Renu Laboratories, Inc. SULFUR 1.4 g/14g E 20171231 76348-409_227b9114-a5b6-63dd-e054-00144ff8d46c 76348-409 HUMAN OTC DRUG Dr. Canuso foot repair serum Tolnaftate serum LOTION TOPICAL 20150820 OTC MONOGRAPH FINAL part333C Renu Laboratories, Inc. TOLNAFTATE .3 g/28g E 20171231 76348-411_22b8b9dd-35b5-3845-e054-00144ff8d46c 76348-411 HUMAN OTC DRUG Dr CANUSO fungal nail eraser Tolnaftate Oil OIL TOPICAL 20150811 OTC MONOGRAPH FINAL part333C Renu Laboratories, Inc. TOLNAFTATE .14 g/14g E 20171231 76348-412_3f28eae1-162b-5146-e054-00144ff8d46c 76348-412 HUMAN OTC DRUG CliXit (TM) acne eraser Acne Pen CREAM TOPICAL 20151025 OTC MONOGRAPH FINAL part333D Renu Laboratories, Inc. SULFUR .28 g/2.8g E 20171231 76348-413_3dbff672-1b9a-708b-e054-00144ff8d46c 76348-413 HUMAN OTC DRUG Margarite Zinc Cream Zinc Cream CREAM TOPICAL 20131015 OTC MONOGRAPH FINAL part333D Renu Laboratories, Inc. SULFUR 1.12 g/28g E 20171231 76348-414_40443c5f-b88a-5d78-e054-00144ff88e88 76348-414 HUMAN OTC DRUG ARCTIC HEAT Menthol, Methyl Salicylate CREAM TOPICAL 20150917 OTC MONOGRAPH NOT FINAL part348 Renu Laboratories, Inc. MENTHOL; METHYL SALICYLATE 2.24; 11.2 g/112g; g/112g E 20171231 76348-415_55a063cc-7639-6156-e054-00144ff88e88 76348-415 HUMAN OTC DRUG TLC Plus Anesthetic S Lidocaine SPRAY TOPICAL 20170728 OTC MONOGRAPH FINAL part346 Renu Laboratories, Inc. LIDOCAINE HYDROCHLORIDE 2.36 g/59g N 20181231 76348-416_562cc300-b53c-6320-e054-00144ff8d46c 76348-416 HUMAN OTC DRUG TLC Plus Anesthetic G Lidocaine Gel GEL TOPICAL 20170728 OTC MONOGRAPH NOT FINAL part348 Renu Laboratories, Inc. LIDOCAINE HYDROCHLORIDE 2.36 g/59g N 20181231 76349-001_e218da95-44b4-4ba2-9207-2e74c15e3a62 76349-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20110701 NDA NDA205767 Southern Gas and Supply LLC OXYGEN 995 mL/L N 20181231 76349-002_37c90232-a10e-457a-8641-58c7e7a1a38f 76349-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20111101 NDA NDA205766 Southern Gas & Supply LLC NITROGEN 995 mL/L N 20181231 76351-100_9fcf3934-4860-4dcb-99a4-bbcc5ae2c9ee 76351-100 HUMAN OTC DRUG Tinted Moisturizer SPF-15 Octinoxate, Octisalate and Titanium Dioxide CREAM TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part352 Femme Couture International, Inc OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE 3.06; 2.04; 1.53 g/51.03g; g/51.03g; g/51.03g E 20171231 76354-001_06ecd42c-57dd-42b0-b68b-b411ec21bfdc 76354-001 HUMAN OTC DRUG ELF Clarifying Pressed SALICYLIC ACID POWDER TOPICAL 20111001 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g E 20171231 76354-002_770a04d4-b06b-4de6-ad8b-844134c32476 76354-002 HUMAN OTC DRUG eyes lips face Mineral Blemish Kit Box SULFUR POWDER TOPICAL 20101201 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SULFUR 3 g/100g E 20171231 76354-003_c57f553c-0f12-4a56-880e-2791e7d8e677 76354-003 HUMAN OTC DRUG ELF Zit Zapper SALICYLIC ACID LIQUID TOPICAL 20111009 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g E 20171231 76354-004_373f9ebc-1c67-4927-8d1d-d7fbba9e12a7 76354-004 HUMAN OTC DRUG ELF Conceler Pencil and Brush SALICYLIC ACID PASTE TOPICAL 20111001 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 2 g/100g E 20171231 76354-005_7b1b209a-bb90-42bb-ad82-c540afc7a903 76354-005 HUMAN OTC DRUG ELF Super Glossy Lip Shine SPF 15 OXYBENZONE CREAM TOPICAL 20111009 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OXYBENZONE; OCTINOXATE 6; 7.5 g/100g; g/100g E 20171231 76354-006_18a261f3-a4c9-4c08-9d82-0403cfb9baa5 76354-006 HUMAN OTC DRUG ELF Tinted Moisturizer SPF 15 OXYBENZONE CREAM TOPICAL 20111009 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OXYBENZONE; OCTINOXATE 3.5; 7.5 g/100g; g/100g E 20171231 76354-007_46fd6413-2d52-4e15-b1c7-5862a9a8875e 76354-007 HUMAN OTC DRUG ELF Mineral Foundation SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20111009 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; g/100g E 20171231 76354-008_eae6dcae-f600-48e5-82a1-365265d1729b 76354-008 HUMAN OTC DRUG eyes lips face Mineral Concealer SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20111009 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; g/100g E 20171231 76354-009_842b8834-ad10-43c1-b074-42e6fbef78dd 76354-009 HUMAN OTC DRUG ELF Personal Blend Foundation SPF 15 TITANIUM DIOXIDE POWDER TOPICAL 20110501 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; g/100g E 20171231 76354-010_ea6530da-ae23-4a46-a161-7d43d62792d6 76354-010 HUMAN OTC DRUG ELF Mineral Lip Tint SPF 8 TITANIUM DIOXIDE POWDER TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE 4 g/100g E 20171231 76354-011_c4b1fc33-34d8-44b7-ad07-870c9ad4941c 76354-011 HUMAN OTC DRUG ELF Conditioning Lip Balm SPF 15 OXYBENZONE CREAM TOPICAL 20111008 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OXYBENZONE; OCTINOXATE 3; 7.5 g/100g; g/100g E 20171231 76354-012_7b1564ad-8c9b-4881-b1d9-d3ac83a8f4a1 76354-012 HUMAN OTC DRUG ELF Lip Balm SPF 15 OXYBENZONE CREAM TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OXYBENZONE; OCTINOXATE 5; 7.5 g/100g; g/100g E 20171231 76354-013_85c9673e-8c23-4d5e-a317-5bdf16dc579c 76354-013 HUMAN OTC DRUG ELF Lip Balm SPF 15 Color OXYBENZONE CREAM TOPICAL 20111008 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OXYBENZONE; OCTINOXATE 5; 7.5 g/100g; g/100g E 20171231 76354-014_b99dd686-5122-4d5b-9501-e8cad64ee7ab 76354-014 HUMAN OTC DRUG ELF Flawless Finish Foundation SPF 15 Oil Free TITANIUM DIOXIDE CREAM TOPICAL 20111003 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; TROLAMINE SALICYLATE 5.5; 2 g/100g; g/100g E 20171231 76354-015_17c68a53-3e2b-46e3-b302-2c4ac1b6dfe1 76354-015 HUMAN OTC DRUG ELF Tinted Moisturizer SPF 20 OXYBENZONE CREAM TOPICAL 20111010 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OXYBENZONE; OCTINOXATE; TITANIUM DIOXIDE 3.5; 6; 5 g/100g; g/100g; g/100g E 20171231 76354-016_3cfa20d3-3d15-45d6-b446-d434c0f60674 76354-016 HUMAN OTC DRUG ELF SPF 45 Sunscreen UVA/UVB Protection TITANIUM DIOXIDE POWDER TOPICAL 20111022 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 23.3; 18.7 g/100g; g/100g E 20171231 76354-017_0da93bfa-fe51-40fb-9e38-1983a5b7d8b1 76354-017 HUMAN OTC DRUG ELF Zit Eraser SALICYLIC ACID LIQUID TOPICAL 20120129 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g E 20171231 76354-018_6cd7b4d5-fd54-47d5-b07b-75ddd62bfe5e 76354-018 HUMAN OTC DRUG ELF Zit Zapping Conceler SALICYLIC ACID PASTE TOPICAL 20120102 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g E 20171231 76354-019_9d992249-d527-4b0a-8761-87e51d643293 76354-019 HUMAN OTC DRUG ELF ACNE Fighting Foundation SALICYLIC ACID CREAM TOPICAL 20130309 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL E 20171231 76354-101_475770fe-c7e3-4cba-bfa4-adfe3e67cf7d 76354-101 HUMAN OTC DRUG ELF BB SPF-20 OXYBENZONE, OCTISALATE, AND OCTINOXATE CREAM TOPICAL 20131010 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC OXYBENZONE; OCTISALATE; OCTINOXATE 4; 5; 7.5 g/100g; 1/100g; g/100g E 20171231 76354-102_71f6322f-35fc-47cf-adb8-41e658982c1c 76354-102 HUMAN OTC DRUG ELF TINTED MOISTURIZER SPF-20 OCTINOXATE, OXYBENZONE, AND TITANIUM DIOXIDE CREAM TOPICAL 20131010 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 6; 3.5; 5 g/100mL; 1/100mL; g/100mL E 20171231 76354-103_5c4bf2cf-3501-40e5-85cc-4bdbf79cd625 76354-103 HUMAN OTC DRUG MINERAL FOUNDATION SPF 15 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20131010 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; 1/100g E 20171231 76354-104_b2d22849-2d43-4286-a9d1-cff30680e9ff 76354-104 HUMAN OTC DRUG PERSONAL BLEND FOUNDATION SPF 15 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20131010 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; 1/100g E 20171231 76354-105_23529c68-00c0-499d-86d4-c1c9e699c3c6 76354-105 HUMAN OTC DRUG ELF Super Glossy Lip Shine SPF 15 OXYBENZONE, OCTINOXATE CREAM TOPICAL 20111009 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OXYBENZONE; OCTINOXATE 6; 7.5 g/100g; g/100g E 20171231 76354-106_0093cbb0-585f-4188-aedb-05cde9b94b2a 76354-106 HUMAN OTC DRUG FLAWLESS FINISH FOUNDATION SPF 15 SUNSCREEN OCTISALATE, TITANIUM DIOXIDE LIQUID TOPICAL 20131010 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC OCTISALATE; TITANIUM DIOXIDE 2; 5.5 g/100g; 1/100g E 20171231 76354-107_1629814c-6550-4ec0-b4b1-5ef80843dcfa 76354-107 HUMAN OTC DRUG SPF-45 SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20140512 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 23.3; 18.7 g/100g; 1/100g E 20171231 76354-108_7051244f-cd47-498e-a489-0e738ed21b92 76354-108 HUMAN OTC DRUG SPF-20 FACE PRIMER OCTINOXATE, OXYBENZONE, OCTISALATE CREAM TOPICAL 20140512 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7; 5; 5 g/100g; g/100g; g/100g E 20171231 76354-109_cd855251-daf3-4e9e-b9ce-695ac9d26f4a 76354-109 HUMAN OTC DRUG MINERAL CONCEALER SPF 20 TITANIUM DIOXIDE, ZINC OXIDE POWDER TOPICAL 20131010 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; ZINC OXIDE 10; 15 g/100g; 1/100g E 20171231 76354-110_27bf3917-40f1-45a5-83f9-d398c36439ce 76354-110 HUMAN OTC DRUG LIP BALM SPF 15 OCTINOXATE, OXYBENZONE LIPSTICK TOPICAL 20140610 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE 7.5; 5 g/100g; g/100g E 20171231 76354-112_2bdf899a-05d5-4c24-b7ce-03c8971179de 76354-112 HUMAN OTC DRUG ELF TINTED MOISTURIZER SPF-20 OCTINOXATE, OXYBENZONE, OCTISALATE CREAM TOPICAL 20140826 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 3; 5 g/100mL; 1/100mL; g/100mL E 20171231 76354-113_6659c3f5-1cf5-4a2e-91d6-a0b4fffe3297 76354-113 HUMAN OTC DRUG FLAWLESS FINISH FOUNDATION SPF 25 SUNSCREEN ZINC OXIDE LIQUID TOPICAL 20150426 OTC MONOGRAPH FINAL part352 J. A. Cosmetics U.S. INC ZINC OXIDE 13.8 g/100mL E 20171231 76354-201_fdba8c12-9186-4605-9cbc-216a4a1f176f 76354-201 HUMAN OTC DRUG CLARIFYING PRESSED POWDER SALICYLIC ACID POWDER TOPICAL 20131010 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g E 20171231 76354-202_0cf32254-c84c-4f5a-8e3e-2eac2bf37e9f 76354-202 HUMAN OTC DRUG ZIT ZAPPER SALICYLIC ACID CREAM TOPICAL 20131010 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g E 20171231 76354-203_5442cc78-46c4-4ac0-8dc8-4938aa81d00e 76354-203 HUMAN OTC DRUG ACNE FIGHTING FOUNDATION SALICYLIC ACID CREAM TOPICAL 20140202 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL E 20171231 76354-204_326e4709-c99b-4276-80a6-53f7bbe2c3ad 76354-204 HUMAN OTC DRUG CONCEALER PENCIL AND BRUSH SALICYLIC ACID CREAM TOPICAL 20140202 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID 2 1/100g E 20171231 76354-205_17074116-d927-4be7-8556-458e2417165f 76354-205 HUMAN OTC DRUG MINERAL BLEMISH KIT SULFUR POWDER TOPICAL 20131010 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SULFUR 3 1/100g E 20171231 76354-206_53d31a29-b5f8-42e5-8774-ea72a764493a 76354-206 HUMAN OTC DRUG ZIT ERASER SALICYLIC ACID CREAM TOPICAL 20131010 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g E 20171231 76354-207_ffa4a258-3d5e-41cd-a749-cafceb384814 76354-207 HUMAN OTC DRUG FLAWLESS FACE SALICYLIC ACID POWDER TOPICAL 20150127 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100g E 20171231 76354-208_d6eeefa3-e54f-46a0-9a02-3edb4e000a9e 76354-208 HUMAN OTC DRUG BLEMISH CONTROL FACE PRIMER SALICYLIC ACID CREAM TOPICAL 20150127 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID 2 g/100mL E 20171231 76354-209_76ea48cb-bee7-48f1-8260-d952d8cff0d2 76354-209 HUMAN OTC DRUG ACNE FIGHTING SALICYLIC ACID GEL TOPICAL 20150127 OTC MONOGRAPH FINAL part333D J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100mL E 20171231 76354-210_068ce9fc-3ca5-4338-88dc-6a2a55abdaec 76354-210 HUMAN OTC DRUG ELF Blemish Control Face Primer Clear SALICYLIC ACID CREAM TOPICAL 20170817 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 2 g/100mL N 20181231 76354-601_98854b04-9360-4a3a-b270-cadb32584cca 76354-601 HUMAN OTC DRUG ELF Porcelain ACNE Fighting Foundation SALICYLIC ACID CREAM TOPICAL 20150809 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-602_5d596ebd-19f0-4da3-97e9-5460b56195db 76354-602 HUMAN OTC DRUG ELF Buff ACNE Fighting Foundation SALICYLIC ACID CREAM TOPICAL 20151010 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-603_3bee17b0-f659-4b3f-9729-cbe72e4e92e1 76354-603 HUMAN OTC DRUG ELF Beige ACNE Fighting Foundation SALICYLIC ACID CREAM TOPICAL 20151010 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-604_1dcfff5c-d996-4d38-8e5e-bf9b0cf891a2 76354-604 HUMAN OTC DRUG ELF Sand ACNE Fighting Foundation SALICYLIC ACID CREAM TOPICAL 20150809 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-605_0ad1aee9-153f-4a85-9e00-1def26a6a72f 76354-605 HUMAN OTC DRUG ELF Caramel ACNE Fighting Foundation SALICYLIC ACID CREAM TOPICAL 20150809 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-607_a7a8faff-c104-499a-94ea-96baa4b6a07b 76354-607 HUMAN OTC DRUG ELF Ivory ACNE Fighting Foundation SALICYLIC ACID CREAM TOPICAL 20151010 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-609_5cf44969-9139-4751-b144-b3c072360b23 76354-609 HUMAN OTC DRUG ELF Broad Spectrum SPF 20 Sunscreen Fair BB Cream OCTINOXATE CREAM TOPICAL 20151010 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-610_d4465256-ad76-4bfa-a129-575ade4ac5cb 76354-610 HUMAN OTC DRUG ELF Broad Spectrum SPF 20 Sunscreen Buff BB Cream OCTINOXATE CREAM TOPICAL 20151010 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-611_70830b71-c23f-44e0-befb-5549327914e8 76354-611 HUMAN OTC DRUG ELF Broad Spectrum SPF 20 Sunscreen Nude BB Cream OCTINOXATE CREAM TOPICAL 20151010 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-612_24f0bf13-f881-486c-aeb8-bc45e3fea722 76354-612 HUMAN OTC DRUG ELF Broad Spectrum SPF 20 Sunscreen Beige BB Cream OCTINOXATE CREAM TOPICAL 20151010 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-614_3666907c-aa51-4e68-bc41-0cefc2151b89 76354-614 HUMAN OTC DRUG ELF Broad Spectrum SPF 20 Sunscreen Dark BB Cream OCTINOXATE CREAM TOPICAL 20151010 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-615_5fcaffc8-0676-44ff-a042-320ab272c7c4 76354-615 HUMAN OTC DRUG ELF Clear SPF 20 Sunscreen Face Primer OCTINOXATE CREAM TOPICAL 20151010 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7; 5; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-616_b03008e5-8950-4452-b2e4-e8befe137c96 76354-616 HUMAN OTC DRUG ELF ACNE Fighting Spot Gel with Aloe Clear SALICYLIC ACID GEL TOPICAL 20151020 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 1 g/100mL N 20181231 76354-617_b874eed7-7b26-436e-85a4-cdfaea52bc30 76354-617 HUMAN OTC DRUG ELF Beautifully Bare Foundation Serum Broad Spectrum SPF 25 Sunscreen Fair Light ZINC OXIDE CREAM TOPICAL 20151010 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC ZINC OXIDE 13.8 g/100mL N 20181231 76354-618_a5a40654-4b91-4441-9ef7-decff09c0290 76354-618 HUMAN OTC DRUG ELF Beautifully Bare Foundation Serum Broad Spectrum SPF 25 Sunscreen Light Medium ZINC OXIDE CREAM TOPICAL 20151010 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC ZINC OXIDE 13.8 g/100mL N 20181231 76354-619_2d9533ea-350f-42e6-b172-7d2ea55f08d1 76354-619 HUMAN OTC DRUG ELF Beautifully Bare Foundation Serum Broad Spectrum SPF 25 Sunscreen Medium Dark ZINC OXIDE CREAM TOPICAL 20151010 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC ZINC OXIDE 13.8 g/100mL N 20181231 76354-620_d6a2ebaa-59ba-4901-95c5-b68466e52ee0 76354-620 HUMAN OTC DRUG ELF Beautifully Bare Foundation Serum Dark Deep With Goji Berry SPF 25 TITANIUM DIOXIDE CREAM TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; OCTISALATE; OCTINOXATE; OCTOCRYLENE 8.5; 2; 7.5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76354-621_c9f283ce-6daa-4872-a26b-66543efda712 76354-621 HUMAN OTC DRUG ELF Beautifully Bare Foundation Serum Deep With Goji Berry SPF 25 TITANIUM DIOXIDE CREAM TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; OCTISALATE; OCTINOXATE; OCTOCRYLENE 8.5; 2; 7.5; 4 g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76354-624_592fe628-228b-45ff-8f94-e2dae7eb210c 76354-624 HUMAN OTC DRUG ELF Clear Blemish Control Face Primer SALICYLIC ACID CREAM TOPICAL 20151010 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 2 g/100mL N 20181231 76354-625_eb10c49d-47c7-469e-9fb6-3a47d27ff62f 76354-625 HUMAN OTC DRUG ELF Oil free flawless Finish SPF 15 Sunscreen Foundation Porcelain OCTISALATE CREAM TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTISALATE; TITANIUM DIOXIDE 2; 5.5 g/100mL; g/100mL N 20181231 76354-626_91e2ae31-53f5-41ed-913e-b2076d59cc20 76354-626 HUMAN OTC DRUG ELF Oil free flawless Finish SPF 15 Sunscreen Foundation Sand OCTISALATE CREAM TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTISALATE; TITANIUM DIOXIDE 2; 5.5 g/100mL; g/100mL N 20181231 76354-627_fc3bebc4-324a-4655-b9a8-2c3e42124ccc 76354-627 HUMAN OTC DRUG ELF Oil free flawless Finish SPF 15 Sunscreen Foundation Buff OCTISALATE CREAM TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTISALATE; TITANIUM DIOXIDE 2; 5.5 g/100mL; g/100mL N 20181231 76354-628_b1591b12-22e7-4680-b2ea-8b6c64c5ab85 76354-628 HUMAN OTC DRUG ELF Oil free flawless Finish SPF 15 Sunscreen Foundation Caramel OCTISALATE CREAM TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTISALATE; TITANIUM DIOXIDE 2; 5.5 g/100mL; g/100mL N 20181231 76354-629_33f62388-5eb9-4e3b-ba8d-e238c75e8259 76354-629 HUMAN OTC DRUG ELF Oil free flawless Finish SPF 15 Sunscreen Foundation Almond OCTISALATE CREAM TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTISALATE; TITANIUM DIOXIDE 2; 5.5 g/100mL; g/100mL N 20181231 76354-630_b7061ba0-baeb-475f-ad5c-3d9c7ffdd556 76354-630 HUMAN OTC DRUG ELF Oil free flawless Finish SPF 15 Sunscreen Foundation Coco OCTISALATE CREAM TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTISALATE; TITANIUM DIOXIDE 2; 5.5 g/100mL; g/100mL N 20181231 76354-631_d465be01-a162-48ed-bdbf-ec988cee17ec 76354-631 HUMAN OTC DRUG ELF Flawless Finish Foundation Oil Free SPF 15 Sunscreen Light Ivory TITANIUM DIOXIDE CREAM TOPICAL 20170526 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; OCTISALATE; OCTINOXATE 4.45; 3; 4 g/100mL; g/100mL; g/100mL N 20181231 76354-632_703557f0-5ec9-4b37-bd23-f996ec705b6b 76354-632 HUMAN OTC DRUG ELF Flawless Finish Foundation Oil Free SPF 15 Sunscreen Alabaster TITANIUM DIOXIDE CREAM TOPICAL 20170811 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; OCTISALATE; OCTINOXATE 4.45; 3; 4 g/100mL; g/100mL; g/100mL N 20181231 76354-701_334e904b-e867-406d-9d5d-3ef7e0ad1d98 76354-701 HUMAN OTC DRUG ELF ACNE Fighting Foundation Porcelain SALICYLIC ACID CREAM TOPICAL 20150809 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-702_936e8559-8888-464c-ad35-a77c19a2b60d 76354-702 HUMAN OTC DRUG ELF ACNE Fighting Foundation Buff SALICYLIC ACID CREAM TOPICAL 20150809 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-703_38016309-f15f-401b-9d70-57b99c1ccc67 76354-703 HUMAN OTC DRUG ELF ACNE Fighting Foundation Beige SALICYLIC ACID CREAM TOPICAL 20150809 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-704_4a0621bc-8f9a-4806-b169-10379d9920ef 76354-704 HUMAN OTC DRUG ELF ACNE Fighting Foundation Sand SALICYLIC ACID CREAM TOPICAL 20150809 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-705_800265db-8c9e-4a11-92b3-81b424b5b774 76354-705 HUMAN OTC DRUG ELF ACNE Fighting Foundation Caramel SALICYLIC ACID CREAM TOPICAL 20150809 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-706_1424e668-b97f-48be-85f5-8d779a73f363 76354-706 HUMAN OTC DRUG ELF ACNE Fighting Foundation Coffee SALICYLIC ACID CREAM TOPICAL 20150809 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-707_39a430fd-0618-42f9-bbc8-14e9321f7164 76354-707 HUMAN OTC DRUG ELF ACNE Fighting Foundation Ivory SALICYLIC ACID CREAM TOPICAL 20150809 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-708_58202833-d252-4e14-8361-8e8699c20387 76354-708 HUMAN OTC DRUG ELF ACNE Fighting Foundation Chestnut SALICYLIC ACID CREAM TOPICAL 20150809 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID .5 g/100mL N 20181231 76354-709_4f197f83-c1b4-49de-9788-bfbd3d92d5c3 76354-709 HUMAN OTC DRUG ELF Broad Spectrum SPF 20 Sunscreen BB Cream Fair OCTINOXATE CREAM TOPICAL 20150809 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-710_dd453ddf-bb5c-44fd-bb04-9911e2f20622 76354-710 HUMAN OTC DRUG ELF Broad Spectrum SPF 20 Sunscreen BB Cream Buff OCTINOXATE CREAM TOPICAL 20150809 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-711_d7de0e7e-5d36-4af8-847b-e64602579f03 76354-711 HUMAN OTC DRUG ELF Broad Spectrum SPF 20 Sunscreen BB Cream Nude OCTINOXATE CREAM TOPICAL 20150809 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-712_e556262f-288c-4b4d-94c5-f18f99e1e29d 76354-712 HUMAN OTC DRUG ELF Broad Spectrum SPF 20 Sunscreen BB Cream Beige OCTINOXATE CREAM TOPICAL 20150809 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-713_a6c2b862-449e-4b1b-b7ff-e542fffc872e 76354-713 HUMAN OTC DRUG ELF Broad Spectrum SPF 20 Sunscreen BB Cream Medium OCTINOXATE CREAM TOPICAL 20150809 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-714_988afedd-1d2e-4396-9f3f-2140f8084976 76354-714 HUMAN OTC DRUG ELF Broad Spectrum SPF 20 Sunscreen BB Cream Dark OCTINOXATE CREAM TOPICAL 20150809 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 4; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-715_ea4871f3-4fd5-4fb1-9bfb-2837506a54a0 76354-715 HUMAN OTC DRUG ELF SPF 20 Sunscreen Face Primer Clear OCTINOXATE CREAM TOPICAL 20150809 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7; 5; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-716_8dd34b98-7a2b-4c1b-898b-7fe9ee92dfad 76354-716 HUMAN OTC DRUG ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Porcelain OCTINOXATE CREAM TOPICAL 20150829 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 3; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-717_d5a38243-a608-45f6-b50e-eadacd515800 76354-717 HUMAN OTC DRUG ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Nude OCTINOXATE CREAM TOPICAL 20150829 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 3; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-718_6bd840ce-19ee-43e9-8760-d34166477298 76354-718 HUMAN OTC DRUG ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Beige OCTINOXATE CREAM TOPICAL 20150829 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 3; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-719_d27f43ed-7554-4f75-8a2d-6e607dbd31ad 76354-719 HUMAN OTC DRUG ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Sand OCTINOXATE CREAM TOPICAL 20150829 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 3; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-720_30abeb1a-4654-4c8c-b657-6f942b4e3be0 76354-720 HUMAN OTC DRUG ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Almond OCTINOXATE CREAM TOPICAL 20150829 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 3; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-721_39a34e3d-ad1e-4460-97ba-3607f264a8e7 76354-721 HUMAN OTC DRUG ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Mocha OCTINOXATE CREAM TOPICAL 20150829 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 3; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-722_11904acc-c847-4c69-9e4e-b15af059d817 76354-722 HUMAN OTC DRUG ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Espresso OCTINOXATE CREAM TOPICAL 20150829 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 3; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-723_bf696986-74fb-48e0-80a0-5262fe32197e 76354-723 HUMAN OTC DRUG ELF SPF 20 Sunscreen UVA/UVB Tinted Moisturizer Ivory OCTINOXATE CREAM TOPICAL 20150829 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE 7.5; 3; 5 g/100mL; g/100mL; g/100mL N 20181231 76354-724_2ab39e1d-8517-4533-99df-61fd4426c3c2 76354-724 HUMAN OTC DRUG ELF Blemish Control Face Primer Clear SALICYLIC ACID CREAM TOPICAL 20160122 OTC MONOGRAPH FINAL part358H J. A. Cosmetics U.S. INC SALICYLIC ACID 2 g/100mL N 20181231 76354-801_feb78a7e-88b0-47fe-9dd3-b9436c5b99d7 76354-801 HUMAN OTC DRUG ELF Daily Hydration Moisturizer SPF 15 OCTINOXATE CREAM TOPICAL 20160104 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC OCTINOXATE; OXYBENZONE; OCTISALATE; OCTOCRYLENE; AVOBENZONE 7.5; 3; 5; 6; 3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76354-803_3fece881-40e7-4ccf-91c9-a99a8afde285 76354-803 HUMAN OTC DRUG ELF Beauty Shield SPF 50 Skin Shielding Moisturizer TITANIUM DIOXIDE CREAM TOPICAL 20170526 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC TITANIUM DIOXIDE; OCTISALATE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE 11; 5; 7.5; 5; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL N 20181231 76354-804_a04cf3f7-d8f0-4f04-9d12-0c092bf19924 76354-804 HUMAN OTC DRUG ELF Beauty Shield SPF 50 Skin Shielding Primer ZINC OXIDE CREAM TOPICAL 20170526 OTC MONOGRAPH NOT FINAL part352 J. A. Cosmetics U.S. INC ZINC OXIDE 25 g/100mL N 20181231 76357-106_f89f4900-e664-4495-ad93-e867c84b0b24 76357-106 HUMAN OTC DRUG SmartMouth Advance Clinical Formula Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20110617 OTC MONOGRAPH FINAL part355 Triumph Pharmaceuticals Inc. SODIUM MONOFLUOROPHOSPHATE 17 g/170g E 20171231 76357-175_da4ba437-72c6-4eaa-bf7d-1e153f6b672d 76357-175 HUMAN OTC DRUG SmartMouth Premium Action SmartMouth Advanced Clinical Formula (ACF) Sodium Monofluorophosphate PASTE, DENTIFRICE DENTAL 20180201 OTC MONOGRAPH FINAL part355 Triumph Pharmaceuticals Inc. SODIUM MONOFLUOROPHOSPHATE 10.21 g/96.4g N 20191231 76357-200_39b69f78-0708-49b8-8f1f-865dd952d093 76357-200 HUMAN OTC DRUG SmartMouth Advance Clinical Formula Mint Cetylpyridinium Chloride KIT 20110617 OTC MONOGRAPH NOT FINAL part356 Triumph Pharmaceuticals Inc. N 20181231 76357-209_f64c77a7-7235-410f-b885-ada8494eb742 76357-209 HUMAN OTC DRUG SmartMouth Gum and Plaque Formula Cetylpyridinium Chloride KIT 20150928 OTC MONOGRAPH NOT FINAL part356 Triumph Pharmaceuticals Inc. E 20171231 76357-250_cfb8aed9-32c6-4db3-94b1-abeecbff57b0 76357-250 HUMAN OTC DRUG SmartMouth Clinical Gum and Plaque Formula Cetylpyridinium Chloride KIT 20150928 OTC MONOGRAPH NOT FINAL part356 Triumph Pharmaceuticals Inc. N 20191231 76357-255_cfb8aed9-32c6-4db3-94b1-abeecbff57b0 76357-255 HUMAN OTC DRUG SmartMouth Clinical Gum and Plaque Formula Cetylpyridinium Chloride KIT 20180201 OTC MONOGRAPH NOT FINAL part356 Triumph Pharmaceuticals Inc. N 20191231 76357-280_25c0ff16-55db-4750-921c-0f5ba092ee5a 76357-280 HUMAN OTC DRUG SmartMouth Advanced Clinical DDS Formula Mint (ACF) Cetylpyridinium Chloride KIT 20180201 OTC MONOGRAPH NOT FINAL part356 Triumph Pharmaceuticals Inc. N 20191231 76363-029_69d4e189-3862-45ee-8a86-5adcb7478a9b 76363-029 HUMAN OTC DRUG LOVEA Titanium dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH FINAL part352 Laboratoires Biocos TITANIUM DIOXIDE 12.1 g/100g E 20171231 76365-0101_f719162f-cb78-487c-b172-ac10d009e6f5 76365-0101 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine hydrochloride CAPSULE ORAL 20120601 ANDA ANDA075464 Prodigy Health Supplier FLUOXETINE HYDROCHLORIDE 10 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 76365-0102_f719162f-cb78-487c-b172-ac10d009e6f5 76365-0102 HUMAN PRESCRIPTION DRUG Fluoxetine Fluoxetine hydrochloride CAPSULE ORAL 20120601 ANDA ANDA075464 Prodigy Health Supplier FLUOXETINE HYDROCHLORIDE 20 mg/1 Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] E 20171231 76366-001_88d492e5-b745-4877-8c9e-36a2740461f1 76366-001 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19930101 NDA NDA205865 Cryo Weld Corporation OXYGEN 99 L/100L E 20171231 76366-002_4b7fa3b3-61c5-48b3-8bd5-f7254da352b6 76366-002 HUMAN PRESCRIPTION DRUG NITROGEN NITROGEN GAS RESPIRATORY (INHALATION) 20120601 UNAPPROVED MEDICAL GAS Cryo Weld Corporation NITROGEN 99 L/100L E 20171231 76369-1001_b2ca2351-0c83-4085-b2d7-4f775d4dbf38 76369-1001 HUMAN OTC DRUG Clara PSYLLIUM HUSK GRANULE ORAL 20110826 UNAPPROVED DRUG OTHER Handock Cosmetics Inc PSYLLIUM HUSK 3.25 g/5g E 20171231 76369-2001_0af8b8c1-6825-420f-846d-7d398e56cc02 76369-2001 HUMAN OTC DRUG MSM (MoSaengMo) POLYQUATERNIUM-10 (400 CPS AT 2%) SHAMPOO TOPICAL 20110830 UNAPPROVED DRUG OTHER Handock Cosmetics Inc POLYQUATERNIUM-10 (400 CPS AT 2%) .4 mL/200mL E 20171231 76369-3001_d9895fee-6b24-46b0-b8fd-735c23e1059e 76369-3001 HUMAN OTC DRUG MSM (MoSaengMo) PROPYLENE GLYCOL LIQUID TOPICAL 20110830 UNAPPROVED DRUG OTHER Handock Cosmetics Inc PROPYLENE GLYCOL 23.85 mL/150mL E 20171231 76369-4001_43b82c7a-5c61-48d7-9e50-4878a42aee6b 76369-4001 HUMAN OTC DRUG MSM (MoSaengMo) POLYQUATERNIUM-10 (400 CPS AT 2%) SHAMPOO TOPICAL 20110830 UNAPPROVED DRUG OTHER Handock Cosmetics Inc POLYQUATERNIUM-10 (400 CPS AT 2%) .4 mL/200mL E 20171231 76369-5001_01778970-950f-43ff-b8b8-4e90e98f8e25 76369-5001 HUMAN OTC DRUG MSM (MoSaengMo) PROPYLENE GLYCOL LIQUID TOPICAL 20111111 UNAPPROVED DRUG OTHER Handock Cosmetics Inc PROPYLENE GLYCOL 23.85 mL/150mL E 20171231 76369-6001_668ce835-5a1c-4454-9360-e7b74a4576b5 76369-6001 HUMAN OTC DRUG MSM (MoSaengMo) PROPYLENE GLYCOL LIQUID TOPICAL 20111111 UNAPPROVED DRUG OTHER Handock Cosmetics Inc PROPYLENE GLYCOL 23.85 mL/150mL E 20171231 76369-8001_49ca634d-dc44-24b8-e054-00144ff88e88 76369-8001 HUMAN OTC DRUG CLARA PSYLLIUM HUSK, GARCINIA CAMBOGIA GRANULE ORAL 20170303 UNAPPROVED DRUG OTHER Handock Cosmetics Co., Ltd. GARCINIA CAMBOGIA FRUIT; PSYLLIUM HUSK .45; 2.45 g/5g; g/5g N 20181231 76369-9001_4f23af51-842d-3d7d-e054-00144ff88e88 76369-9001 HUMAN OTC DRUG SINTONG Menthol CREAM ORAL 20170401 OTC MONOGRAPH NOT FINAL part348 Handock Cosmetics Co., Ltd. MENTHOL 6 g/100mL N 20181231 76370-0001_5e20d274-d05b-400c-e053-2991aa0a1b69 76370-0001 HUMAN OTC DRUG Tazza Benzalkonium Chloride CLOTH TOPICAL 20131101 OTC MONOGRAPH NOT FINAL part333E Terraboost Media LLC BENZALKONIUM CHLORIDE .0062 g/1 N 20181231 76370-0002_5e2133c2-032e-4c16-e053-2991aa0ac61b 76370-0002 HUMAN OTC DRUG Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20151027 OTC MONOGRAPH NOT FINAL part333E Terraboost Media LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 76370-0003_5e218603-4801-d859-e053-2991aa0a7241 76370-0003 HUMAN OTC DRUG Hand Sanitizer Ethanol LIQUID TOPICAL 20151027 OTC MONOGRAPH NOT FINAL part333E Terraboost Media LLC ALCOHOL 70 mL/100mL N 20181231 76370-0004_5e21c1d5-20f1-2078-e053-2991aa0a8d4a 76370-0004 HUMAN OTC DRUG Tazza Ethanol CLOTH TOPICAL 20160802 OTC MONOGRAPH NOT FINAL part333E Terraboost Media LLC ALCOHOL 28 g/1 N 20181231 76370-0005_5e75a407-bac4-fdfc-e053-2a91aa0af957 76370-0005 HUMAN OTC DRUG Hand Sanitizer Ethanol LIQUID TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Terraboost Media LLC ALCOHOL 70 mL/100mL N 20181231 76370-0006_464f97a0-622c-224f-e054-00144ff8d46c 76370-0006 HUMAN OTC DRUG Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20170117 OTC MONOGRAPH NOT FINAL part333E Terraboost Media LLC BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 76376-618_c473129f-1c60-42b8-b0a3-2dd4cb02c833 76376-618 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F-18 INJECTION, SOLUTION INTRAVENOUS 20111114 ANDA ANDA203771 Hamamatsu/Queen’s PET Imaging Center, LLC FLUDEOXYGLUCOSE F-18 100 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 76378-011_0d71b8ab-a8f1-45e3-bf3d-ebf6c87d81e8 76378-011 HUMAN OTC DRUG Servo Stat-Foam Alcohol LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. ALCOHOL 62 mL/100mL N 20181231 76378-012_9140f7cc-cb62-4857-a084-c119435e9c35 76378-012 HUMAN OTC DRUG Servo-Stat T Triclosan LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. TRICLOSAN .3 mL/100mL N 20181231 76378-013_ecd181cb-587e-4f45-810a-968c9f09d668 76378-013 HUMAN OTC DRUG Servo-Stat TE Triclosan LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. TRICLOSAN .3 mL/100mL N 20181231 76378-014_7f5dcc02-f810-4a35-abbd-e6b3a46dc6a5 76378-014 HUMAN OTC DRUG Servo-Stat T Foam Triclosan LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. TRICLOSAN .3 mL/100mL N 20181231 76378-015_e763efd9-071d-4094-9138-da787c53888a 76378-015 HUMAN OTC DRUG Servo-Stat Alcohol GEL TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. ALCOHOL 62 mL/100mL N 20181231 76378-016_5be6c348-c031-498a-a6b5-bee5e709731f 76378-016 HUMAN OTC DRUG Servo-Stat Balm Alcohol GEL TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. ALCOHOL 62 mL/100mL N 20181231 76378-017_0f59fb74-ab4b-41b5-b8cc-1937c5e06214 76378-017 HUMAN OTC DRUG Servo-Stat P Chloroxylenol LIQUID TOPICAL 20110201 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. CHLOROXYLENOL .6 mL/100mL N 20181231 76378-020_135e864b-449f-4e9c-aaa8-16c1e9075fef 76378-020 HUMAN OTC DRUG Servo Stat BAC BENZALKONIUM CHLORIDE LIQUID TOPICAL 20131114 OTC MONOGRAPH NOT FINAL part333A Enzyme Solutions, Inc. BENZALKONIUM CHLORIDE 1 mg/mL N 20181231 76379-100_48ca69c4-d391-4ee9-ad2d-ba266b55c574 76379-100 HUMAN OTC DRUG Game Day MSC Mainstreet Collection Hand Sanitizer ALCOHOL LIQUID TOPICAL 20110803 OTC MONOGRAPH FINAL part333E Mainstreet Collection ALCOHOL 75 mL/100mL E 20171231 76384-001_cac36aa0-45ea-45f5-983f-72f933c36c79 76384-001 HUMAN OTC DRUG Quality Petroleum Jelly White petroleum JELLY TOPICAL 20110815 OTC MONOGRAPH FINAL part347 Worldwide Sales & Distribution Corp. PETROLATUM 1 g/g E 20171231 76384-002_cac36aa0-45ea-45f5-983f-72f933c36c79 76384-002 HUMAN OTC DRUG Quality Petroleum Jelly Baby Fresh Scent White petroleum JELLY TOPICAL 20110815 OTC MONOGRAPH FINAL part347 Worldwide Sales & Distribution Corp. PETROLATUM 1 g/g E 20171231 76384-003_cac36aa0-45ea-45f5-983f-72f933c36c79 76384-003 HUMAN OTC DRUG Quality Petroleum Cocoa Butter Scent White petroleum JELLY TOPICAL 20101101 OTC MONOGRAPH FINAL part347 Worldwide Sales & Distribution Corp. PETROLATUM 1 g/g E 20171231 76384-004_cac36aa0-45ea-45f5-983f-72f933c36c79 76384-004 HUMAN OTC DRUG Quality Petroleum Aloe Vera White petroleum JELLY TOPICAL 20110815 OTC MONOGRAPH FINAL part347 Worldwide Sales & Distribution Corp. PETROLATUM 1 g/g E 20171231 76384-005_b20373e6-e571-4556-94d9-42dd43d15865 76384-005 HUMAN OTC DRUG ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Worldwide Sales & Distribution Corp. ISOPROPYL ALCOHOL 50 mL/100mL E 20171231 76384-006_b25a1d39-4bc1-4d80-b756-10a7ec4d9f8d 76384-006 HUMAN OTC DRUG ISOPROPYL WINTER GREEN RUBBING ALCOHOL ISOPROPYL ALCOHOL LIQUID TOPICAL 20110815 OTC MONOGRAPH NOT FINAL part333A Worldwide Sales & Distribution Corp. ISOPROPYL ALCOHOL 50 mL/100mL E 20171231 76384-007_e853c662-f640-481a-866c-35e1aebe957d 76384-007 HUMAN OTC DRUG Hydrogen Peroxide Hydrogen Peroxide SOLUTION TOPICAL 20110825 OTC MONOGRAPH NOT FINAL part333A Worldwide Sales & Distribution Corp. HYDROGEN PEROXIDE .3 kg/100L E 20171231 76385-100_c265374e-9962-4004-a74b-6605330055c7 76385-100 HUMAN PRESCRIPTION DRUG METHSCOPOLAMINE BROMIDE methscopolamine bromide TABLET ORAL 20131001 ANDA ANDA200602 BAYSHORE PHARMACEUTICALS LLC METHSCOPOLAMINE BROMIDE 2.5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 76385-101_c265374e-9962-4004-a74b-6605330055c7 76385-101 HUMAN PRESCRIPTION DRUG METHSCOPOLAMINE BROMIDE methscopolamine bromide TABLET ORAL 20131001 ANDA ANDA200602 BAYSHORE PHARMACEUTICALS LLC METHSCOPOLAMINE BROMIDE 5 mg/1 Anticholinergic [EPC],Cholinergic Antagonists [MoA] N 20181231 76385-102_dcdbdf1f-a1ca-4c99-b67a-d63d39aac687 76385-102 HUMAN PRESCRIPTION DRUG Primaquine Phosphate Primaquine Phosphate TABLET ORAL 20140801 ANDA ANDA204476 Bayshore Pharmaceuticals, LLC PRIMAQUINE PHOSPHATE 15 mg/1 Antimalarial [EPC] N 20191231 76385-103_416da80b-6b05-42ee-acb2-6f26f33bceba 76385-103 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20140131 ANDA ANDA090168 Bayshore Pharmaceuticals LLC (NJ) BENZTROPINE MESYLATE .5 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 76385-104_416da80b-6b05-42ee-acb2-6f26f33bceba 76385-104 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20140131 ANDA ANDA090168 Bayshore Pharmaceuticals LLC (NJ) BENZTROPINE MESYLATE 1 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 76385-105_416da80b-6b05-42ee-acb2-6f26f33bceba 76385-105 HUMAN PRESCRIPTION DRUG BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET ORAL 20140131 ANDA ANDA090168 Bayshore Pharmaceuticals LLC (NJ) BENZTROPINE MESYLATE 2 mg/1 Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 76385-110_5f1a4361-9db0-4b62-914f-eb6420e0022a 76385-110 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20161001 ANDA ANDA078384 Bayshore Pharmaceuticals LLC CARVEDILOL 3.125 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 76385-111_5f1a4361-9db0-4b62-914f-eb6420e0022a 76385-111 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20161001 ANDA ANDA078384 Bayshore Pharmaceuticals LLC CARVEDILOL 6.25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 76385-112_5f1a4361-9db0-4b62-914f-eb6420e0022a 76385-112 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20161001 ANDA ANDA078384 Bayshore Pharmaceuticals LLC CARVEDILOL 12.5 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 76385-113_5f1a4361-9db0-4b62-914f-eb6420e0022a 76385-113 HUMAN PRESCRIPTION DRUG Carvedilol Carvedilol TABLET, FILM COATED ORAL 20161001 ANDA ANDA078384 Bayshore Pharmaceuticals LLC CARVEDILOL 25 mg/1 Adrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC] N 20181231 76385-114_ffd6866d-47ea-4b6c-8bbf-c1cb36dd6fb2 76385-114 HUMAN PRESCRIPTION DRUG Sotalol Sotalol Hydrochloride TABLET ORAL 20171215 ANDA ANDA207428 Bayshore Pharmaceuticals LLC SOTALOL HYDROCHLORIDE 80 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 76385-115_ffd6866d-47ea-4b6c-8bbf-c1cb36dd6fb2 76385-115 HUMAN PRESCRIPTION DRUG Sotalol Sotalol Hydrochloride TABLET ORAL 20171206 ANDA ANDA207428 Bayshore Pharmaceuticals LLC SOTALOL HYDROCHLORIDE 120 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 76385-116_ffd6866d-47ea-4b6c-8bbf-c1cb36dd6fb2 76385-116 HUMAN PRESCRIPTION DRUG Sotalol Sotalol Hydrochloride TABLET ORAL 20171206 ANDA ANDA207428 Bayshore Pharmaceuticals LLC SOTALOL HYDROCHLORIDE 160 mg/1 Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] N 20181231 76385-123_bc7de472-b52d-4506-a32e-cdb88ad76309 76385-123 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20180115 ANDA ANDA208507 Bayshore Pharmaceuticals LLC METHOCARBAMOL 500 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 76385-124_bc7de472-b52d-4506-a32e-cdb88ad76309 76385-124 HUMAN PRESCRIPTION DRUG Methocarbamol Methocarbamol TABLET, FILM COATED ORAL 20180115 ANDA ANDA208507 Bayshore Pharmaceuticals LLC METHOCARBAMOL 750 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] N 20181231 76388-283_dbd38aa4-cf25-42ca-823d-17a746b3f380 76388-283 HUMAN PRESCRIPTION DRUG CYCLESSA desogestrel and ethinyl estradiol KIT 20150731 NDA NDA021090 Aspen Global Inc. N 20181231 76388-635_3a381a0f-800e-4adb-801d-7307e5eaa266 76388-635 HUMAN PRESCRIPTION DRUG LEUKERAN chlorambucil TABLET, FILM COATED ORAL 19850213 NDA NDA010669 Aspen Global Inc. CHLORAMBUCIL 2 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 76388-713_f8b23be9-e202-44bc-ad18-ced393b82107 76388-713 HUMAN PRESCRIPTION DRUG MYLERAN busulfan TABLET, FILM COATED ORAL 19850321 NDA NDA009386 Aspen Global Inc. BUSULFAN 2 mg/1 Alkylating Activity [MoA],Alkylating Drug [EPC] N 20181231 76388-880_cfcdec00-6da5-41ec-8d9e-cf33629b002a 76388-880 HUMAN PRESCRIPTION DRUG TABLOID thioguanine TABLET ORAL 20130312 NDA NDA012429 Aspen Global Inc. THIOGUANINE 40 mg/1 Antimetabolite [EPC] N 20181231 76391-234_78eb4626-20b4-4c08-9711-91d908b95f17 76391-234 HUMAN PRESCRIPTION DRUG OXYGEN OXYGEN GAS RESPIRATORY (INHALATION) 19960101 NDA NDA205840 Bluegrass Oxygen, Inc. OXYGEN 99 L/100L N 20181231 76394-3811_5ad35215-4e5e-1e08-e053-2a91aa0a9cc2 76394-3811 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20130627 ANDA ANDA203811 University of California, Los Angeles FLUDEOXYGLUCOSE F-18 40 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 76394-3812_5ad359b5-ccf0-48f7-e053-2991aa0a2934 76394-3812 HUMAN PRESCRIPTION DRUG Ammonia N 13 AMMONIA N-13 INJECTION INTRAVENOUS 20130627 ANDA ANDA203812 University of California, Los Angeles AMMONIA N-13 37.5 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 76398-001_c08ab60d-9dea-4c24-9951-3baf4a1da91b 76398-001 HUMAN OTC DRUG ILLUMINATING PROTECTIVE PRIMER SPF 12 OCTINOXATE, HOMOSALATE CREAM TOPICAL 20090901 OTC MONOGRAPH NOT FINAL part352 TOM FORD BEAUTY DIST OCTINOXATE; HOMOSALATE 7.5; 5 mL/100mL; mL/100mL E 20171231 76398-003_d960df1a-d844-4461-be4d-6a39691a173e 76398-003 HUMAN OTC DRUG TRACELESS PERFECTING FOUNDATION BROAD SPECTRUM SPF 15 octinoxate and titanium dioxide LIQUID TOPICAL 20140401 OTC MONOGRAPH NOT FINAL part352 TOM FORD BEAUTY DIST OCTINOXATE; TITANIUM DIOXIDE .03132; .01728 g/100mL; g/100mL N 20181231 76398-004_3b6e313c-e5c2-40df-a774-2b3354a59fb6 76398-004 HUMAN OTC DRUG TOM FORD FACE PROTECT BROAD SPECTRUM SPF 50 avobenzone, homosalate, octisalate, octocrylene, and oxybenzone LOTION TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 TOM FORD BEAUTY DIST AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE .03105; .05175; .05175; .029898; .03105 g/mL; g/mL; g/mL; g/mL; g/mL N 20181231 76398-005_d216ae18-609b-4732-8ab0-e19c4235dcb0 76398-005 HUMAN OTC DRUG TOM FORD SOLEIL TINTED MOISTURIZER BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE CREAM TOPICAL 20171001 OTC MONOGRAPH NOT FINAL part352 TOM FORD BEAUTY DIST OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE .0825; .022; .0583 g/mL; g/mL; g/mL N 20181231 76401-1001_39669a6b-9ab6-4a99-8e78-95db3a7ccefd 76401-1001 HUMAN OTC DRUG Korea Gongjin-Dan PANAX GINSENG FRUIT PELLET ORAL 20120622 UNAPPROVED DRUG OTHER Songjeongo OM Clinic PANAX GINSENG FRUIT 229 mg/4g E 20171231 76402-050_95e250ce-732f-47ea-8194-87f912350855 76402-050 HUMAN OTC DRUG HILLYARD AMB So ap Chloroxylenol LIQUID TOPICAL 20030430 OTC MONOGRAPH NOT FINAL part333E Hillyard GMP CHLOROXYLENOL .003 mg/mL N 20181231 76402-051_008753e4-0d63-471a-b657-2bae0d29f72e 76402-051 HUMAN OTC DRUG HILLYARD Clean Assist Antibacterial So ap Chloroxylenol LIQUID TOPICAL 20080930 OTC MONOGRAPH NOT FINAL part333E Hillyard GMP CHLOROXYLENOL .003 mg/mL N 20181231 76402-052_add5c785-c499-4890-abf4-fddc490b3954 76402-052 HUMAN OTC DRUG HILLYARD D.G.A. Plus Antimicrobial So ap Chloroxylenol LIQUID TOPICAL 20051130 OTC MONOGRAPH NOT FINAL part333E Hillyard GMP CHLOROXYLENOL .003 mg/mL N 20181231 76402-080_e694336f-5aae-4ece-ad6c-f8f3980c62d4 76402-080 HUMAN OTC DRUG HILLYARD D.G.A. Plus Foam Antimicrobial Hand So ap Chloroxylenol LIQUID TOPICAL 20070830 OTC MONOGRAPH NOT FINAL part333E Hillyard GMP CHLOROXYLENOL .003 mg/mL N 20181231 76402-081_6abd1204-e4c7-4445-8971-ce182ef17970 76402-081 HUMAN OTC DRUG HILLYARD NT Peach Antimicrobial Foam Cleanser Chloroxylenol LIQUID TOPICAL 20070830 OTC MONOGRAPH NOT FINAL part333E Hillyard GMP CHLOROXYLENOL .003 mg/mL N 20181231 76402-402_50154e37-515a-4a03-8e0e-91c0c4531ad7 76402-402 HUMAN OTC DRUG Hillyard Instant Hand Sanitizer Ethyl Alcohol GEL TOPICAL 20120321 OTC MONOGRAPH NOT FINAL part333E Hillyard GMP ALCOHOL 62 mL/100mL N 20181231 76402-403_a066bd4e-8f1d-4dfe-8754-fc7fd5ae48f9 76402-403 HUMAN OTC DRUG Hillyard Alcohol Free Foaming Instant Hand Sanitizer Benzalkonium Chloride LIQUID TOPICAL 20120229 OTC MONOGRAPH NOT FINAL part333E Hillyard GMP BENZALKONIUM CHLORIDE .1 g/100mL N 20181231 76402-408_d2b2581d-0e45-4b4d-8610-248bf9d2bf75 76402-408 HUMAN OTC DRUG Hillyard Citrus Fresh Antimicrobial Foaming Chloroxylenol LIQUID TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part333E Hillyard GMP CHLOROXYLENOL .5 g/100mL N 20181231 76402-410_4acdbf3e-fa79-468f-9e18-fcf9b1f35707 76402-410 HUMAN OTC DRUG Hillyard Foaming Instant Hand Sanitizer Alcohol LIQUID TOPICAL 20120207 OTC MONOGRAPH NOT FINAL part333E Hillyard GMP ALCOHOL 62 mL/100mL N 20181231 76402-419_81148442-6ee2-4655-85e4-27c2753c5c27 76402-419 HUMAN OTC DRUG Hillyard E2 Food Industry Foaming Benzalkonium Chloride LIQUID TOPICAL 20150901 OTC MONOGRAPH NOT FINAL part333E Hillyard GMP BENZALKONIUM CHLORIDE .13 g/100mL N 20181231 76405-010_865235f8-9151-47c5-96f8-b531c8abeff7 76405-010 HUMAN OTC DRUG Spa Originals Instant Hand Sanitizer ETHYL ALCOHOL LIQUID TOPICAL 20110822 OTC MONOGRAPH NOT FINAL part333E Custom Solutions, Inc. ALCOHOL 62 mL/100mL E 20171231 76405-011_9078ddd7-2401-4e8d-8dac-98d1e2b4f279 76405-011 HUMAN OTC DRUG Spa Originals Antibacterial Gold Hand TRICLOSAN SOAP TOPICAL 20110822 OTC MONOGRAPH NOT FINAL part333E Custom Solutions, Inc TRICLOSAN .12 mL/100mL E 20171231 76413-100_e0ed8955-149b-48c2-ae48-7470de932f00 76413-100 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 19940930 ANDA ANDA064076 Central Texas Community Health Centers AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 76413-101_a246c0fb-d73d-422a-b849-d4475234dcc4 76413-101 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 19960718 NDA AUTHORIZED GENERIC NDA050711 Central Texas Community Health Centers AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 76413-102_27be7d59-83b8-4190-8b98-1a5536a6f4f8 76413-102 HUMAN PRESCRIPTION DRUG azithromycin azithromycin TABLET, FILM COATED ORAL 19960718 NDA AUTHORIZED GENERIC NDA050711 Central Texas Community Health Centers AZITHROMYCIN DIHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 76413-104_3e883b5b-743a-49eb-969d-f51a60d55fc2 76413-104 HUMAN PRESCRIPTION DRUG Cyclafem 7/7/7 norethindrone and ethinyl estradiol KIT 20101116 ANDA ANDA076338 Central Texas Community Health Centers N 20181231 76413-105_cc2dcaa8-e850-41b0-8f04-f7bfbf1a99e3 76413-105 HUMAN PRESCRIPTION DRUG Cyclafem 1/35 norethindrone and ethinyl estradiol KIT 20101112 ANDA ANDA076337 Central Texas Community Health Centers N 20181231 76413-106_996a7020-a3c1-4585-b987-16b778da513f 76413-106 HUMAN PRESCRIPTION DRUG Erythromycin Erythromycin OINTMENT OPHTHALMIC 19940729 ANDA ANDA064067 Central Texas Community Health Centers ERYTHROMYCIN 5 mg/g Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 76413-107_8728da2a-3051-4cf3-8474-aa099604dcd8 76413-107 HUMAN PRESCRIPTION DRUG Fluocinonide Fluocinonide CREAM TOPICAL 19900930 ANDA ANDA072488 Central Texas Community Health Centers FLUOCINONIDE .5 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 76413-108_a00d5b49-7f35-4b61-b9b6-d4f3bb977ef7 76413-108 HUMAN PRESCRIPTION DRUG Folic Acid Folic Acid TABLET ORAL 20100604 ANDA ANDA040756 Central Texas Community Health Centers FOLIC ACID 1 mg/1 N 20181231 76413-109_e8f12577-ef36-4213-b81f-936ccdf79f67 76413-109 HUMAN PRESCRIPTION DRUG Ketorolac Tromethamine Ketorolac Tromethamine TABLET, FILM COATED ORAL 19980617 ANDA ANDA074754 Central Texas Community Health Centers KETOROLAC TROMETHAMINE 10 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 76413-110_f8bdd7e3-2100-4190-9c0d-231a79d1d528 76413-110 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20120322 ANDA ANDA200839 Central Texas Community Health Centers LEVOFLOXACIN 750 mg/1 N 20181231 76413-111_251b7a38-aaa5-434d-9870-f0e2eba9155c 76413-111 HUMAN PRESCRIPTION DRUG Levonorgestrel and Ethinyl Estradiol Levonorgestrel and Ethinyl Estradiol KIT 20130320 ANDA ANDA091425 Central Texas Community Health Centers N 20181231 76413-113_748d33ad-cd03-4afd-ae10-7acd9dc35a0c 76413-113 HUMAN PRESCRIPTION DRUG Macrobid Nitrofurantoin Monohydrate/Macrocrystalline CAPSULE ORAL 20110531 NDA NDA020064 Central Texas Community Health Centers NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE 25; 75 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 76413-114_1f6e73ef-b770-45d8-830c-80918792caad 76413-114 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070027 Central Texas Community Health Centers METRONIDAZOLE 250 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 76413-115_b3c486ec-536b-4c0e-bcba-3d7432ea17b8 76413-115 HUMAN PRESCRIPTION DRUG Nitrofurantoin Monohydrate/Macrocrystals Nitrofurantoin Monohydrate and Nitrofurantoin, macrocrystalline CAPSULE ORAL 20040323 ANDA ANDA076648 Central Texas Community Health Centers NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN 75; 25 mg/1; mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient],Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 76413-116_a6a5ef37-d5c0-4c6f-b9d5-7396f956679c 76413-116 HUMAN PRESCRIPTION DRUG Myzilra Levonorgestrel and Ethinyl Estradiol KIT 20120112 ANDA ANDA077502 Central Texas Community Health Centers N 20181231 76413-117_0e4b9bf8-fc5e-4833-a425-79ec052a5625 76413-117 HUMAN PRESCRIPTION DRUG Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS AURICULAR (OTIC) 19960828 ANDA ANDA064065 Central Texas Community Health Centers HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] N 20181231 76413-118_eaffdcd9-9696-4aeb-b705-3d244ecb9ed8 76413-118 HUMAN PRESCRIPTION DRUG Norethindrone Norethindrone TABLET ORAL 20130712 ANDA ANDA201483 Central Texas Community Health Centers NORETHINDRONE .35 mg/1 Progesterone Congeners [Chemical/Ingredient],Progestin [EPC] N 20181231 76413-119_b96e0f7d-9aef-4014-94ec-d90357dd7990 76413-119 HUMAN PRESCRIPTION DRUG nystatin nystatin CREAM TOPICAL 19790201 ANDA ANDA062129 Central Texas Community Health Centers NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] N 20181231 76413-120_8cc9492c-d487-4dc4-a506-6a57d8c11d48 76413-120 HUMAN PRESCRIPTION DRUG Nystatin and Triamcinolone Acetonide Nystatin and Triamcinolone Acetonide CREAM TOPICAL 19871222 ANDA ANDA062364 Central Texas Community Health Centers NYSTATIN; TRIAMCINOLONE ACETONIDE 100000; 1 [USP'U]/g; mg/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 76413-121_76ffb9b1-4163-4245-bd80-511e7f145139 76413-121 HUMAN PRESCRIPTION DRUG Previfem norgestimate and ethinyl estradiol KIT 20040109 ANDA ANDA076334 Central Texas Community Health Centers N 20181231 76413-122_21659fde-28d9-4457-81dc-fdf007143ae0 76413-122 HUMAN PRESCRIPTION DRUG Permethrin Permethrin CREAM TOPICAL 20060811 ANDA ANDA076369 Central Texas Community Health Centers PERMETHRIN 50 mg/g Pyrethrins [Chemical/Ingredient],Pyrethroid [EPC] N 20181231 76413-123_8b34c079-f577-473b-b33d-f6395321fe90 76413-123 HUMAN PRESCRIPTION DRUG Selenium Sulfide Selenium Sulfide LOTION TOPICAL 19830901 ANDA ANDA088228 Central Texas Community Health Centers SELENIUM SULFIDE 25 mg/mL N 20181231 76413-124_ca111e2f-b81d-4518-9178-8d01ec50ac19 76413-124 HUMAN PRESCRIPTION DRUG SILVADENE silver sulfadiazine CREAM TOPICAL 19731126 NDA NDA017381 Central Texas Community Health Centers SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 76413-125_8b20a13b-2ea2-493d-a4fc-a3587dfd2e30 76413-125 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 20100216 ANDA ANDA090624 Central Texas Community Health Centers SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 76413-126_c7226bf4-78b4-42b8-ab15-8ed0eb5da88a 76413-126 HUMAN PRESCRIPTION DRUG Sulfacetamide Sodium sulfacetamide sodium SOLUTION/ DROPS OPHTHALMIC 19941228 ANDA ANDA040066 Central Texas Community Health Centers SULFACETAMIDE SODIUM 100 mg/mL Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] N 20181231 76413-127_ff8d9902-e869-4bec-b242-0462347830aa 76413-127 HUMAN PRESCRIPTION DRUG Tetracaine Hydrochloride Tetracaine Hydrochloride SOLUTION OPHTHALMIC 19900930 UNAPPROVED DRUG OTHER Central Texas Community Health Centers TETRACAINE HYDROCHLORIDE 5 mg/mL Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 76413-128_e662baa4-6285-46ec-8b0e-c255eca36f71 76413-128 HUMAN PRESCRIPTION DRUG Tri-Sprintec norgestimate and ethinyl estradiol KIT 20031229 ANDA ANDA075808 Central Texas Community Health Centers N 20181231 76413-129_8a8de035-35ed-4c22-bc37-b4d19dbd48b1 76413-129 HUMAN PRESCRIPTION DRUG Triamcinolone Acetonide Triamcinolone Acetonide CREAM TOPICAL 20060928 ANDA ANDA086414 Central Texas Community Health Centers TRIAMCINOLONE ACETONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 76413-130_91980d70-24e4-4907-bdbb-285f3cffd46b 76413-130 HUMAN PRESCRIPTION DRUG Yasmin drospirenone and ethinyl estradiol KIT 20010511 NDA NDA021098 Central Texas Community Health Centers N 20181231 76413-131_177d16c4-c727-4002-a5a5-f470ba11e053 76413-131 HUMAN PRESCRIPTION DRUG NuvaRing etonogestrel and ethinyl estradiol INSERT, EXTENDED RELEASE VAGINAL 20011003 NDA NDA021187 Central Texas Community Health Centers ETONOGESTREL; ETHINYL ESTRADIOL .12; .015 mg/d; mg/d Progesterone Congeners [Chemical/Ingredient],Progestin [EPC],Estrogen [EPC],Estrogen Receptor Agonists [MoA] N 20181231 76413-132_7093b022-3673-4fc1-b51b-7bdb2ced1438 76413-132 HUMAN PRESCRIPTION DRUG Hydrocortisone Acetate HYDROCORTISONE ACETATE SUPPOSITORY RECTAL 19900701 UNAPPROVED DRUG OTHER Central Texas Community Health Centers HYDROCORTISONE ACETATE 25 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 76413-134_da88ef00-fc23-4c34-9556-21b649afd126 76413-134 HUMAN PRESCRIPTION DRUG Metronidazole Metronidazole TABLET ORAL 19900930 ANDA ANDA070033 Central Texas Community Health Centers METRONIDAZOLE 500 mg/1 Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 76413-135_19426b87-9be5-43e6-9665-bdf78842de70 76413-135 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19860825 ANDA ANDA071017 Central Texas Community Health Centers SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 76413-136_329bd5b7-5863-47f8-80b8-bc3f1540d2b3 76413-136 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20010701 ANDA ANDA065028 Central Texas Community Health Centers RIFAMPIN 150 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 76413-137_62a8af62-46ed-4454-8d40-445d8958c25e 76413-137 HUMAN PRESCRIPTION DRUG Rifampin Rifampin CAPSULE ORAL 20010701 ANDA ANDA065028 Central Texas Community Health Centers RIFAMPIN 300 mg/1 Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient] N 20181231 76413-138_b86e9fb5-e25b-4651-bfdf-a9f1b9549e25 76413-138 HUMAN PRESCRIPTION DRUG Lisinopril Lisinopril TABLET ORAL 20020701 ANDA ANDA075743 Central Texas Community Health Centers LISINOPRIL 10 mg/1 Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA] N 20181231 76413-139_0996a36e-ed5e-4c05-a501-14f5f7ab2b98 76413-139 HUMAN PRESCRIPTION DRUG Hydrochlorothiazide Hydrochlorothiazide TABLET ORAL 20020329 ANDA ANDA040412 Central Texas Community Health Centers HYDROCHLOROTHIAZIDE 25 mg/1 Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 76413-140_f2bb49fc-3c90-4292-a5e1-a658b2ce47a7 76413-140 HUMAN PRESCRIPTION DRUG Atenolol Atenolol TABLET ORAL 19920501 ANDA ANDA074052 Central Texas Community Health Centers ATENOLOL 25 mg/1 Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 76413-141_e05bd712-ddf8-4d2e-b437-44957f684c50 76413-141 HUMAN PRESCRIPTION DRUG Amlodipine Besylate Amlodipine Besylate TABLET ORAL 20070921 ANDA ANDA078226 Central Texas Community Health Centers AMLODIPINE BESYLATE 5 mg/1 Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] N 20181231 76413-142_18deecdf-aceb-480d-81fa-c539e059de5b 76413-142 HUMAN PRESCRIPTION DRUG Cephalexin Cephalexin CAPSULE ORAL 20051116 ANDA ANDA065253 Central Texas Community Health Centers CEPHALEXIN 500 mg/1 Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient] N 20181231 76413-143_b918a23d-bca8-4b95-8070-a6d620295c61 76413-143 HUMAN PRESCRIPTION DRUG Amoxicillin Amoxicillin CAPSULE ORAL 20051109 ANDA ANDA065271 Central Texas Community Health Centers AMOXICILLIN 500 mg/1 Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient] N 20181231 76413-144_cf790e8c-577b-40ed-930d-1cf435859be5 76413-144 HUMAN PRESCRIPTION DRUG Nitrofurantoin Nitrofurantion Macrocrystals CAPSULE ORAL 20100927 NDA NDA016620 Central Texas Community Health Centers NITROFURANTOIN 100 mg/1 Nitrofuran Antibacterial [EPC],Nitrofurans [Chemical/Ingredient] N 20181231 76413-145_f91924ce-6feb-42e5-9489-68f11d7acb77 76413-145 HUMAN PRESCRIPTION DRUG ALBENZA albendazole TABLET, FILM COATED ORAL 19960611 NDA NDA020666 Central Texas Community Health Centers ALBENDAZOLE 200 mg/1 Antihelminthic [EPC],Cytochrome P450 1A Inducers [MoA] N 20181231 76413-146_f4b54a8c-fefe-4290-bd07-3d13b4699730 76413-146 HUMAN PRESCRIPTION DRUG Biltricide praziquantel TABLET, FILM COATED ORAL 20110421 NDA NDA018714 Central Texas Community Health Centers PRAZIQUANTEL 600 mg/1 Antihelminthic [EPC] N 20181231 76413-147_4412d832-f7b5-445d-a0ba-44954389f4d5 76413-147 HUMAN PRESCRIPTION DRUG Paromomycin Sulfate Paromomycin Sulfate CAPSULE ORAL 20091022 ANDA ANDA065173 Central Texas Community Health Centers PAROMOMYCIN SULFATE 250 mg/1 Antiprotozoal [EPC] N 20181231 76413-148_4aae986f-a0a8-40f3-b28a-9834544b20d0 76413-148 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19951019 NDA AUTHORIZED GENERIC NDA050710 Central Texas Community Health Centers AZITHROMYCIN DIHYDRATE 100 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 76413-149_493ed0fb-c5df-4f14-9155-ce83e903e6cb 76413-149 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19951019 NDA AUTHORIZED GENERIC NDA050710 Central Texas Community Health Centers AZITHROMYCIN DIHYDRATE 1200 mg/30mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 76413-150_01ca2872-f549-4c69-a8ed-12d2d3dd8397 76413-150 HUMAN PRESCRIPTION DRUG PIRMELLA 7/7/7 NORETHINDRONE AND ETHINYL ESTRADIOL KIT 20130515 ANDA ANDA201510 Central Texas Community Health Centers N 20181231 76413-151_f4465275-8517-40df-90c5-1f2aedd7f3ea 76413-151 HUMAN PRESCRIPTION DRUG Sulfamethoxazole and Trimethoprim Sulfamethoxazole and Trimethoprim TABLET ORAL 19860825 ANDA ANDA071017 Central Texas Community Health Centers SULFAMETHOXAZOLE; TRIMETHOPRIM 800; 160 mg/1; mg/1 Sulfonamide Antimicrobial [EPC],Sulfonamides [Chemical/Ingredient],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] N 20181231 76413-152_1d33196e-e020-4f9d-9a42-d7e22e276e90 76413-152 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20051116 ANDA ANDA065153 Central Texas Community Health Centers AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 76413-153_96c9d895-d470-4ecf-a346-ff9c951d56a5 76413-153 HUMAN PRESCRIPTION DRUG Azithromycin Azithromycin TABLET, FILM COATED ORAL 20060106 ANDA ANDA065225 Central Texas Community Health Centers AZITHROMYCIN MONOHYDRATE 250 mg/1 Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 76413-154_2e678bdb-4af9-4937-800f-8165778b0fe4 76413-154 HUMAN PRESCRIPTION DRUG COARTEM artemether and lumefantrine TABLET ORAL 20090407 NDA NDA022268 Central Texas Community Health Centers ARTEMETHER; LUMEFANTRINE 20; 120 mg/1; mg/1 Antimalarial [EPC],Antimalarial [EPC] N 20181231 76413-155_c970c2ff-1ec3-4cf1-b821-1da35d60f043 76413-155 HUMAN PRESCRIPTION DRUG Ivermectin Ivermectin TABLET ORAL 20141115 ANDA ANDA204154 Central Texas Community Health Centers IVERMECTIN 3 mg/1 Antiparasitic [EPC],Pediculicide [EPC] N 20181231 76413-156_9902c6bb-c820-4ec0-a058-f4c3bcd9a473 76413-156 HUMAN PRESCRIPTION DRUG Metformin hydrochloride METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20060209 ANDA ANDA077336 Central Texas Community Health Centers METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 76413-157_7ea9e4cf-b7d3-40ec-9eac-c5247298ca96 76413-157 HUMAN PRESCRIPTION DRUG azithromycin azithromycin POWDER, FOR SUSPENSION ORAL 19951019 NDA AUTHORIZED GENERIC NDA050710 Central Texas Community Health Centers AZITHROMYCIN DIHYDRATE 200 mg/5mL Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient] N 20181231 76413-301_a368de95-b5b7-4aa2-bde4-ccca6efb42de 76413-301 HUMAN OTC DRUG Acetaminophen Acetaminophen TABLET, COATED ORAL 20121213 OTC MONOGRAPH NOT FINAL part343 Central Texas Community Health Centers ACETAMINOPHEN 325 mg/1 N 20181231 76413-302_3516536e-4b3c-419f-a0e8-35e759fd7d14 76413-302 HUMAN OTC DRUG ACEPHEN Acetaminophen SUPPOSITORY RECTAL 19920327 ANDA ANDA072344 Central Texas Community Health Centers ACETAMINOPHEN 325 mg/1 N 20181231 76413-303_a2fa7abe-a1b3-43f5-b8a4-bd06e113422d 76413-303 HUMAN OTC DRUG Aspirin Aspirin TABLET ORAL 20140731 OTC MONOGRAPH NOT FINAL part343 Central Texas Community Health Centers ASPIRIN 325 mg/1 N 20181231 76413-304_8bb442fa-7008-4025-b482-f59f21a6071f 76413-304 HUMAN OTC DRUG Major Clotrimazole CLOTRIMAZOLE CREAM TOPICAL 20041004 OTC MONOGRAPH FINAL part333C Central Texas Community Health Centers CLOTRIMAZOLE 10 mg/g N 20181231 76413-305_6dbc10cc-a719-45c8-874f-1de2a484123d 76413-305 HUMAN OTC DRUG Clotrimazole Clotrimazole CREAM VAGINAL 19951204 ANDA ANDA072641 Central Texas Community Health Centers CLOTRIMAZOLE 1 g/100g N 20181231 76413-306_6c18aa4b-c649-4da4-ac84-20dad41b3b81 76413-306 HUMAN OTC DRUG Diphenhydramine hydrochloride Diphenhydramine HCl CAPSULE ORAL 19900315 OTC MONOGRAPH FINAL part341 Central Texas Community Health Centers DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 76413-307_e8e8dd30-2442-40c6-a6f8-6768acc84b7b 76413-307 HUMAN OTC DRUG Docusate calcium DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20111201 OTC MONOGRAPH NOT FINAL part334 Central Texas Community Health Centers DOCUSATE CALCIUM 240 mg/1 N 20181231 76413-308_909b743b-50a1-4bb6-afbf-87a8b12157d1 76413-308 HUMAN OTC DRUG Ferrous Sulfate Ferrous Sulfate TABLET, FILM COATED ORAL 20140701 UNAPPROVED DRUG OTHER Central Texas Community Health Centers FERROUS SULFATE 325 mg/1 N 20181231 76413-309_c825a608-fcc7-4d42-a4bb-a95d284596cb 76413-309 HUMAN OTC DRUG Guaifenesin Guaifenesin SOLUTION ORAL 19971001 OTC MONOGRAPH FINAL part341 Central Texas Community Health Centers GUAIFENESIN 100 mg/5mL E 20171231 76413-311_95e16d23-158c-44bc-9bb9-adea5037a4d3 76413-311 HUMAN OTC DRUG Hydrocortisone hydrocortisone CREAM TOPICAL 20011001 OTC MONOGRAPH NOT FINAL part348 Central Texas Community Health Centers HYDROCORTISONE 10 mg/g N 20181231 76413-312_3220f656-2ced-4590-a767-ab9f31f4ed6f 76413-312 HUMAN OTC DRUG Ibuprofen ibuprofen SUSPENSION ORAL 20030828 ANDA ANDA075217 Central Texas Community Health Centers IBUPROFEN 50 mg/1.25mL N 20181231 76413-313_593f0a32-c3b7-4af8-8a32-5d093e18e555 76413-313 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20030624 ANDA ANDA072096 Central Texas Community Health Centers IBUPROFEN 200 mg/1 N 20181231 76413-314_429314ab-b6fc-41e5-8db9-3ac5860a9f0a 76413-314 HUMAN OTC DRUG Loperamide hydrochloride Loperamide Hydrochloride TABLET, FILM COATED ORAL 20030627 ANDA ANDA075232 Central Texas Community Health Centers LOPERAMIDE HYDROCHLORIDE 2 mg/1 N 20181231 76413-317_0c0bb924-fc17-4986-9e88-3ebec04313d7 76413-317 HUMAN OTC DRUG Zantac ranitidine TABLET, COATED ORAL 20061221 NDA NDA020520 Central Texas Community Health Centers RANITIDINE HYDROCHLORIDE 75 mg/1 E 20171231 76413-318_6f218797-be08-4b07-8c82-21e2b57f0eb1 76413-318 HUMAN OTC DRUG Miconazole Nitrate Miconazole Nitrate CREAM VAGINAL 19960222 ANDA ANDA074366 Central Texas Community Health Centers MICONAZOLE NITRATE 20 mg/g N 20181231 76413-319_eefd419d-e356-4318-b2e6-92d9b129d56b 76413-319 HUMAN OTC DRUG Mi-Acid Regular Strength aluminum hydroxide, magnesium hydroxide, dimethicone SUSPENSION ORAL 20110201 OTC MONOGRAPH FINAL part331 Central Texas Community Health Centers ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE 200; 200; 20 mg/5mL; mg/5mL; mg/5mL N 20181231 76413-320_9aee68cd-9481-4a70-ac96-0d86823ec02c 76413-320 HUMAN OTC DRUG Permethrin Permethrin LOTION TOPICAL 20150803 ANDA ANDA076090 Central Texas Community Health Centers PERMETHRIN 1 mg/100mL N 20181231 76413-323_67d3ae0a-3903-4006-9878-2d7290e732aa 76413-323 HUMAN OTC DRUG Plan B One-Step levonorgestrel TABLET ORAL 20131212 NDA NDA021998 Central Texas Community Health Centers LEVONORGESTREL 1.5 mg/1 E 20171231 76413-324_6dc551e1-04a1-47cf-bb45-a7b373fcbd68 76413-324 HUMAN OTC DRUG stool softener DOCUSATE CALCIUM CAPSULE, LIQUID FILLED ORAL 20140530 OTC MONOGRAPH NOT FINAL part334 Central Texas Community Health Centers DOCUSATE CALCIUM 240 mg/1 N 20181231 76413-326_28e65bcc-4f15-403d-bf62-62266b05de95 76413-326 HUMAN OTC DRUG Clotrimazole clotrimazole CREAM VAGINAL 20030812 ANDA ANDA074165 Central Texas Community Health Centers CLOTRIMAZOLE 1 g/100g N 20181231 76413-327_228ef141-0a88-4dba-b7b8-2fdd2eb18572 76413-327 HUMAN OTC DRUG Clotrimazole clotrimazole CREAM VAGINAL 20030812 ANDA ANDA074165 Central Texas Community Health Centers CLOTRIMAZOLE 1 g/100g N 20181231 76413-328_91d0b48d-460c-49f5-bc4d-386139c63671 76413-328 HUMAN OTC DRUG sunmark tussin Guaifenesin SOLUTION ORAL 20140917 OTC MONOGRAPH FINAL part341 Central Texas Community Health Centers GUAIFENESIN 200 mg/10mL N 20181231 76413-329_1074ba44-2d14-486e-a480-3afe457c0b97 76413-329 HUMAN OTC DRUG Sun Mark Tussin DM cough and chest congestion Dextromethorphan Hydrobromide, Guaifenesin SOLUTION ORAL 20030627 OTC MONOGRAPH FINAL part341 Central Texas Community Health Centers DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN 20; 200 mg/10mL; mg/10mL N 20181231 76413-330_7af113ee-f653-452e-a74a-b9d0ed27e6af 76413-330 HUMAN OTC DRUG Sunmark aspirin adult low strength Aspirin TABLET, CHEWABLE ORAL 20030919 OTC MONOGRAPH NOT FINAL part343 Central Texas Community Health Centers ASPIRIN 81 mg/1 N 20181231 76413-332_442f48f1-6fcd-4598-8b1d-312204b2586c 76413-332 HUMAN OTC DRUG Benadryl diphenhydramine hydrochloride CAPSULE, LIQUID FILLED ORAL 20090301 OTC MONOGRAPH FINAL part341 Central Texas Community Health Centers DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 N 20181231 76413-333_3776b551-632c-40ee-aaac-f8a4acefb3f0 76413-333 HUMAN OTC DRUG Diphenhydramine Diphenhydramine Hydrochloride SOLUTION ORAL 20030821 OTC MONOGRAPH FINAL part341 Central Texas Community Health Centers DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL N 20181231 76413-334_e9951e84-d0d0-4561-a9eb-8a052a9bfb1a 76413-334 HUMAN OTC DRUG Sunmark Hydrocortisone with Aloe Maximum Strength Hydrocortisone CREAM TOPICAL 19950823 OTC MONOGRAPH NOT FINAL part348 Central Texas Community Health Centers HYDROCORTISONE 1 g/100g N 20181231 76413-335_494c896e-9a61-4e4a-b301-c81e97ba7bd7 76413-335 HUMAN OTC DRUG Diabetic Tussin Expectorant Guaifenesin LIQUID ORAL 19960101 OTC MONOGRAPH FINAL part341 Central Texas Community Health Centers GUAIFENESIN 100 mg/5mL N 20181231 76413-339_acade163-15ed-48e0-bae8-716474176abf 76413-339 HUMAN OTC DRUG hydrocortisone Hydrocortisone CREAM TOPICAL 20110413 OTC MONOGRAPH NOT FINAL part348 Central Texas Community Health Centers HYDROCORTISONE 1 g/100g N 20181231 76413-343_6dc153b5-8e73-4c2b-b760-302f6954e701 76413-343 HUMAN OTC DRUG Childrens MAPAP Acetaminophen LIQUID ORAL 20150301 OTC MONOGRAPH NOT FINAL part343 Central Texas Community Health Centers ACETAMINOPHEN 160 mg/5mL N 20181231 76413-344_d4a5a980-a780-4bb6-a926-8d6648397db0 76413-344 HUMAN OTC DRUG Childrens Ibuprofen Ibuprofen SUSPENSION ORAL 20060601 ANDA ANDA074916 Central Texas Community Health Centers IBUPROFEN 100 mg/5mL N 20181231 76413-345_a4e2cc6b-a212-47b6-9c53-48fff6f1ab0a 76413-345 HUMAN OTC DRUG Ibuprofen Ibuprofen TABLET, FILM COATED ORAL 20040101 ANDA ANDA075010 Central Texas Community Health Centers IBUPROFEN 200 mg/1 N 20181231 76413-347_c07e79fb-d912-4003-9885-ae3c6b41551e 76413-347 HUMAN OTC DRUG bacitracin zinc, neomycin sulfate and polymyxin b sulfate bacitracin zinc, neomycin sulfate and polymyxin b sulfate OINTMENT TOPICAL 20091201 OTC MONOGRAPH FINAL part333B Central Texas Community Health Centers BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400; 5; 5000 [iU]/g; mg/g; [iU]/g N 20181231 76413-348_c606a3ac-95fd-4be7-952f-f01dbbf0a40c 76413-348 HUMAN OTC DRUG Compound W salicylic acid GEL TOPICAL 20140315 OTC MONOGRAPH FINAL part358B Central Texas Community Health Centers SALICYLIC ACID .17 g/7g N 20181231 76414-010_f78ed317-18b3-4ddb-9087-51e2da410fdf 76414-010 HUMAN OTC DRUG E ENZYME SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE DENTAL 20110301 OTC MONOGRAPH FINAL part355 SAMJOKO SKYBLUE CO., LTD. SODIUM MONOFLUOROPHOSPHATE 1.2 g/200g E 20171231 76417-8200_ba834958-0a80-4778-9383-e3dfc259a2eb 76417-8200 HUMAN OTC DRUG Analgesic menthol SPRAY TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part348 Ouwee Jones, LLC MENTHOL 700 mL/L N 20181231 76419-111_5f12a74d-5877-4392-af9f-9012d9a614d8 76419-111 HUMAN PRESCRIPTION DRUG Fludeoxyglucose F 18 Fludeoxyglucose F 18 INJECTION INTRAVENOUS 20140824 ANDA ANDA203937 Hot Shots NM, LLC dba Midwest Positron Technology, LC FLUDEOXYGLUCOSE F-18 500 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 76419-211_bb070745-362d-4478-a78a-2be214ddc2a7 76419-211 HUMAN PRESCRIPTION DRUG Sodium Fluoride F 18 SODIUM FLUORIDE F-18 INJECTION INTRAVENOUS 20140821 ANDA ANDA204530 Hot Shots NM, LLC dba Midwest Positron Technology, LC SODIUM FLUORIDE F-18 200 mCi/mL Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA] N 20181231 76420-220_c8e3dd91-7e9f-4e48-807a-6df42a81c649 76420-220 HUMAN PRESCRIPTION DRUG Triloan SUIK Triamcinolone Acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20090601 UNAPPROVED DRUG OTHER Asclemed USA, Inc. TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 76420-222_ea8aa14a-1997-4e6c-92ef-582697ec4005 76420-222 HUMAN PRESCRIPTION DRUG Triloan II SUIK Triamcinolone Acetonide INJECTION, SUSPENSION INTRA-ARTICULAR; INTRAMUSCULAR 20090601 UNAPPROVED DRUG OTHER Asclemed USA, Inc. TRIAMCINOLONE ACETONIDE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 76420-230_da9f6c34-b04b-40a3-9eb5-e2a79e91f5f4 76420-230 HUMAN PRESCRIPTION DRUG Marvona SUIK Bupivacaine Hydrochloride INJECTION, SOLUTION EPIDURAL; INFILTRATION 20090908 UNAPPROVED DRUG OTHER Asclemed USA, Inc. BUPIVACAINE HYDROCHLORIDE 5 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 76420-240_1bf84cb3-e313-4292-8179-862bd4fb5f58 76420-240 HUMAN PRESCRIPTION DRUG Betaloan SUIK Betamethasone Sodium Phosphate and Betamethasone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR 20100428 UNAPPROVED DRUG OTHER Asclemed USA, Inc. BETAMETHASONE SODIUM PHOSPHATE; BETAMETHASONE ACETATE 3; 3 mg/mL; mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 76420-250_bc44f8f3-eb19-41b8-a424-f87fd5f047fa 76420-250 HUMAN PRESCRIPTION DRUG Toronova SUIK Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970605 UNAPPROVED DRUG OTHER Asclemed USA, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 76420-252_51f2c7c1-44b1-4c20-b51f-cb62fd38db3f 76420-252 HUMAN PRESCRIPTION DRUG Toronova II SUIK Ketorolac Tromethamine INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 19970605 UNAPPROVED DRUG OTHER Asclemed USA, Inc. KETOROLAC TROMETHAMINE 30 mg/mL Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] N 20181231 76420-260_c28e49e1-48c8-43fb-8d37-4631cc0dc136 76420-260 HUMAN PRESCRIPTION DRUG Medroloan SUIK Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20160629 UNAPPROVED DRUG OTHER Asclemed USA, Inc. METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 76420-262_2dcb4763-b60e-4c25-a0a7-25b54d700d2b 76420-262 HUMAN PRESCRIPTION DRUG Medroloan II SUIK Methylprednisolone Acetate INJECTION, SUSPENSION INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE 20160629 UNAPPROVED DRUG OTHER Asclemed USA, Inc. METHYLPREDNISOLONE ACETATE 40 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 76420-270_17e4ecf6-8b51-4e46-8578-4ec2529d6d90 76420-270 HUMAN PRESCRIPTION DRUG DMT SUIK Dexamethasone Sodium Phosphate INJECTION, SOLUTION INTRAMUSCULAR; INTRAVENOUS 20030529 UNAPPROVED DRUG OTHER Asclemed USA, Inc. DEXAMETHASONE SODIUM PHOSPHATE 10 mg/mL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 76420-313_9dbe8c48-aa9a-420b-a644-f317cfe5ccd1 76420-313 HUMAN PRESCRIPTION DRUG Cadira Compliant Blood Stat Lidocaine / Prilocaine CREAM TOPICAL 20030827 UNAPPROVED DRUG OTHER Asclemed USA, Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 76420-351_3bc4ea2f-5536-4dba-9c2a-327ddd3905be 76420-351 HUMAN PRESCRIPTION DRUG Eha Lidocaine Hydrochloride LOTION TOPICAL 20160607 UNAPPROVED DRUG OTHER Asclemed USA, Inc. LIDOCAINE HYDROCHLORIDE 4 g/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76420-449_c8108fcb-4d62-49c7-904a-15efc3d3cdb7 76420-449 HUMAN OTC DRUG XOLIDO Lidocaine HCl CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Asclemed USA, Inc LIDOCAINE HYDROCHLORIDE 2 g/mL N 20181231 76420-450_211fa989-fe5b-4941-ba7a-c533e6397903 76420-450 HUMAN OTC DRUG Calypxo Pain Relief Methyl Salicylate, Menthol CREAM TOPICAL 20140115 OTC MONOGRAPH NOT FINAL part348 Asclemed USA, Inc METHYL SALICYLATE; MENTHOL 10; 3 g/100g; g/100g N 20181231 76420-451_ca2e9823-76e3-42b3-83eb-17fc31e2ef5d 76420-451 HUMAN OTC DRUG XOLIDO Lidocaine HCl CREAM TOPICAL 20130405 OTC MONOGRAPH NOT FINAL part348 Asclemed USA, Inc LIDOCAINE HYDROCHLORIDE 4 g/mL N 20181231 76420-520_03dec439-2035-481d-96b1-5410e20071bd 76420-520 HUMAN PRESCRIPTION DRUG Physicians EZ Use M-pred Methylprednisolone Acetate, Bupivacaine Hydrochloride, Povidone-Iodine KIT EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE; TOPICAL 20130530 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-524_900a2e38-b1a4-4a5f-b89e-f83989711145 76420-524 HUMAN PRESCRIPTION DRUG Physician EZ Use Joint Tunnel and Trigger Kit AMMONIA, LIDOCAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINE KIT INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; RESPIRATORY (INHALATION); TOPICAL 20130701 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-527_568716e6-ad5a-42d0-bc8c-4ebf2b3ddffc 76420-527 HUMAN PRESCRIPTION DRUG Physicians EZ Use B-12 Compliance Physicians EZ Use B-12 Compliance KIT INTRAMUSCULAR; SUBCUTANEOUS; TOPICAL 20001018 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-603_4ea03e73-54e0-447e-8832-12047ebb70e2 76420-603 HUMAN PRESCRIPTION DRUG Adyphren Kit Epinephrine and Isopropyl Alcohol KIT INTRAMUSCULAR; INTRAOCULAR; SUBCUTANEOUS 20161004 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-604_c82ddb6b-6bea-498f-8162-e6045e66c51f 76420-604 HUMAN PRESCRIPTION DRUG Adyphren II Kit Epinephrine and Isopropyl Alcohol KIT INTRAMUSCULAR; INTRAOCULAR; SUBCUTANEOUS 20161004 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-605_38d2322e-bd66-4309-9e01-eedcadc09aee 76420-605 HUMAN PRESCRIPTION DRUG Adyphren Amp Kit Epinephrine and Isopropyl Alcohol KIT INTRAMUSCULAR; SUBCUTANEOUS; TOPICAL 20161027 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-606_13120a09-90fc-4fc3-955c-16935739e541 76420-606 HUMAN PRESCRIPTION DRUG Adyphren Amp II Kit Epinephrine and Isopropyl Alcohol KIT INTRAMUSCULAR; SUBCUTANEOUS; TOPICAL 20161027 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-620_45300a02-0dd5-4c42-be98-f3a5aae8324e 76420-620 HUMAN PRESCRIPTION DRUG Advanced DNA Medicated Collection LIDOCAINE HYDROCHLORIDE, GLYCERIN KIT ORAL; TOPICAL 19950710 UNAPPROVED DRUG OTHER Asclemed USA, Inc N 20181231 76420-625_354bc0ff-e60e-4e39-923f-c4a2facf01a9 76420-625 HUMAN PRESCRIPTION DRUG PCP 100 Kit Magesium Citrate, Bisacodyl, Petrolatum, Polyethylene Glycol 3350, Metoclopramide KIT ORAL; TOPICAL 20140102 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-635_188a3505-977d-484e-bb18-38d524027840 76420-635 HUMAN PRESCRIPTION DRUG Advanced DNA Medicated Collection Kit II LIDOCAINE HYDROCHLORIDE, GLYCERIN KIT ORAL; TOPICAL 20140204 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-639_2e6788cb-f27f-4f92-af64-204a8c75cc17 76420-639 HUMAN PRESCRIPTION DRUG Advanced DNA Medicated Collection Kit III LIDOCAINE HYDROCHLORIDE, GLYCERIN KIT ORAL; TOPICAL 20140204 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-641_31b8b141-cf1a-4bc7-b679-b1a23cc85c39 76420-641 HUMAN PRESCRIPTION DRUG LIDO BDK Lidocaine, Prilocaine CREAM TOPICAL 20030827 UNAPPROVED DRUG OTHER Asclemed USA, Inc. LIDOCAINE; PRILOCAINE 25; 25 mg/g; mg/g Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] N 20181231 76420-650_6cbe8e02-b562-4278-b0fd-e9fbee6d6016 76420-650 HUMAN PRESCRIPTION DRUG Testone CIK Testosterone Cypionate, Alcohol KIT INTRAMUSCULAR; TOPICAL 20071221 UNAPPROVED DRUG OTHER Asclemed USA, Inc. CIII N 20181231 76420-715_92554faf-eeaf-445b-8d03-688ca8a77799 76420-715 HUMAN PRESCRIPTION DRUG Accucaine Lidocaine Hydrochloride INJECTION, SOLUTION INFILTRATION 20160201 UNAPPROVED DRUG OTHER Asclemed USA, Inc. LIDOCAINE HYDROCHLORIDE 10 mg/mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76420-720_b0da00d5-e21e-455a-b094-f9bd854209ff 76420-720 HUMAN PRESCRIPTION DRUG Bupivilog Kit marcaine, kenalog, povidone iodine KIT EPIDURAL; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20140204 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-730_04acb1e8-3db5-4458-8aef-b98fd364e999 76420-730 HUMAN PRESCRIPTION DRUG Marlido Kit marcaine, lidocaine, povidone iodine KIT EPIDURAL; INFILTRATION; TOPICAL 20140204 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-735_540c5d78-5a5d-4c5e-9cdf-fa578e92781f 76420-735 HUMAN PRESCRIPTION DRUG Marlido 25 Kit Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine KIT EPIDURAL; INFILTRATION; TOPICAL; TOPICAL 20090908 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-740_d465594b-5f29-445d-9f25-094477914382 76420-740 HUMAN PRESCRIPTION DRUG MLK F1 Kit marcaine, lidocaine, kenalog, povidone iodine KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR 20140116 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-742_2deb48d2-6736-4812-921d-f26a31df6e73 76420-742 HUMAN PRESCRIPTION DRUG MLK Kit F2 marcaine, lidocaine, kenalog, povidone iodine KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20140204 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-743_d0b780eb-e81d-4de8-bd30-3a154e15f041 76420-743 HUMAN PRESCRIPTION DRUG MLK F3 Kit marcaine, lidocaine, kenalog, povidone iodine KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20140204 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-744_f8e7b038-9426-458b-95f1-a2a7cbcbfee5 76420-744 HUMAN PRESCRIPTION DRUG MLK F4 Kit Triamcinolone Acetonide, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine KIT EPIDURAL; INFILTRATION; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20090601 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-750_1a1012f9-1f40-4f04-a91b-fb0778a7f607 76420-750 HUMAN PRESCRIPTION DRUG Dyural 40 Kit Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alcohol KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE; SUBCUTANEOUS; TOPICAL 20140725 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-755_fbf0707b-d16f-4f5b-a436-4360f6c598a6 76420-755 HUMAN PRESCRIPTION DRUG Dyural 80 Kit Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alcohol KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE; SUBCUTANEOUS; TOPICAL 20140801 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-760_d6814216-4441-49f9-871c-4a2f4e6ab64b 76420-760 HUMAN PRESCRIPTION DRUG Lidolog Kit lidocaine, kenalog, povidone iodine KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL 20140204 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-765_2539d4a9-cef7-4caf-9f49-2fe6e75dfcde 76420-765 HUMAN PRESCRIPTION DRUG Betalido Kit Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine, Povidine Iodine KIT INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; PERINEURAL; TOPICAL 20140613 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-766_dbcb651b-9d91-4076-8c02-a1a0eb2e9d44 76420-766 HUMAN PRESCRIPTION DRUG DoubleDex Kit Dexamethasone Sodium Phosphate, Povidine Iodine KIT INTRAMUSCULAR; INTRAVENOUS; TOPICAL 20140725 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-767_753aee8d-fd2a-499d-92b6-517b5a1cc68a 76420-767 HUMAN PRESCRIPTION DRUG Dexlido Kit Dexamethasone Sodium Phosphate, Lidocaine Hydrochloride, Povidine Iodine KIT INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL 20140725 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-769_bcd4a85f-1e68-4ae7-ad29-c1d28039ba47 76420-769 HUMAN PRESCRIPTION DRUG Dexlido-M Kit Dexamethasone Sodium Phosphate, Lidocaine Hydrochloride, Maricaine, Povidine Iodine KIT EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL 20140725 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-771_fe201478-a21d-4561-9c88-61cd5859ff7b 76420-771 HUMAN PRESCRIPTION DRUG Ketorocaine L Kit Ketorolac Tromethamine, Lidocaine Hydrochloride, Povidine Iodine KIT INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL 20140815 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-772_34d86f61-1761-45b3-b277-f4acf505bf63 76420-772 HUMAN PRESCRIPTION DRUG Ketorocaine LM Kit Ketorolac Tromethamine, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine KIT EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL 20140811 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-775_174e7f1e-de68-4d32-a075-96dfeed72917 76420-775 HUMAN PRESCRIPTION DRUG Dyural L Kit Methylprednisolone Acetate, Lidocaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol KIT INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE; TOPICAL 20140815 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-780_7088a615-f0e6-4207-ada4-b5b12e291f6d 76420-780 HUMAN PRESCRIPTION DRUG Multi-Specialty Kit Depo-Medrol, Lidocaine, Isopropyl Alcohol KIT INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE; TOPICAL 20140206 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-782_0fd0bf76-5ab1-4c64-b13c-3a53d28c5462 76420-782 HUMAN PRESCRIPTION DRUG Marbeta L Kit Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; TOPICAL 20100428 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-785_16bdeb10-f47a-4f4f-98d4-db7af03f9912 76420-785 HUMAN PRESCRIPTION DRUG Marbeta 25 Kit Betamethasone Sodium Phosphate and Betamethasone Acetate, Bupivacaine Hydrochloride, Povidine Iodine KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; TOPICAL 20100428 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-795_7bbb8be2-d517-44e1-9af9-9ff539c1a61e 76420-795 HUMAN PRESCRIPTION DRUG Dyural LM Kit Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol KIT EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE; TOPICAL 20140821 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-810_3fd5d26c-fd84-4706-965c-cf1941dcb6f6 76420-810 HUMAN PRESCRIPTION DRUG Mardex 25 Kit Dexamethasone Sodium Phosphate, Bupivacaine Hydrochloride, Povidine Iodine KIT EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL 20140821 UNAPPROVED DRUG OTHER Asclemed USA, Inc. N 20181231 76420-944_733f308e-f01f-4411-b6d9-35356e8b7557 76420-944 HUMAN OTC DRUG EXOTEN-C Methyl salicylate, Menthol, Capsaicin LOTION TOPICAL 20120508 OTC MONOGRAPH NOT FINAL part348 Asclemed USA, Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 10; .002 g/100g; g/100g; g/100g N 20181231 76420-947_efa9024d-873d-4a89-90b2-8b25323bad8a 76420-947 HUMAN OTC DRUG EXOTEN-C METHYL SALICYLATE, MENTHOL, CAPSAICIN LOTION TOPICAL 20170210 OTC MONOGRAPH NOT FINAL part348 Asclemed USA, Inc. METHYL SALICYLATE; MENTHOL; CAPSAICIN 20; 10; .025 g/100g; g/100g; g/100g N 20181231 76426-010_73e23486-6e4a-42cb-ac08-5ce03358dfc2 76426-010 HUMAN OTC DRUG GFS BIOPROTECT HAND SANITIZER ALOE VERA BENZALKONIUM CHLORIDE AEROSOL, FOAM TOPICAL 20110920 OTC MONOGRAPH NOT FINAL part333A GFS US LLC BENZALKONIUM CHLORIDE .0013 g/g E 20171231 76426-011_2c12dd4f-dbdc-49ee-bac6-5ddd0fff5d70 76426-011 HUMAN OTC DRUG GFS BIOPROTECT HAND SANITIZER ALOE VERA - BENZALKONIUM CHLORIDE SPRAY TOPICAL 20110920 OTC MONOGRAPH NOT FINAL part333A GFS US LLC BENZALKONIUM CHLORIDE .0013 g/g E 20171231 76426-012_a99bdb46-8246-4ff6-a5e1-5b25f896b06b 76426-012 HUMAN OTC DRUG GFS BioProtect Hand Sanitizer Aloe Vera Benzalkonium Chloride GEL TOPICAL 20110926 OTC MONOGRAPH NOT FINAL part333A GFS US LLC BENZALKONIUM CHLORIDE .0013 g/g E 20171231 76426-020_367f31e7-2bed-298f-e054-00144ff88e88 76426-020 HUMAN OTC DRUG GFS Bioprotect Alcohol Free Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20160628 OTC MONOGRAPH NOT FINAL part333E GFS-US BENZALKONIUM CHLORIDE 1.3 mg/mL N 20181231 76431-105_87ea13fc-984a-416c-9411-a84d9c0e12b4 76431-105 HUMAN PRESCRIPTION DRUG Juxtapid lomitapide mesylate CAPSULE ORAL 20130103 NDA NDA203858 Aegerion Pharmaceuticals, Inc. LOMITAPIDE MESYLATE 5 mg/1 Microsomal Triglyceride Transfer Protein Inhibitor [EPC],Microsomal Triglyceride Transfer Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 76431-110_87ea13fc-984a-416c-9411-a84d9c0e12b4 76431-110 HUMAN PRESCRIPTION DRUG Juxtapid lomitapide mesylate CAPSULE ORAL 20130103 NDA NDA203858 Aegerion Pharmaceuticals, Inc. LOMITAPIDE MESYLATE 10 mg/1 Microsomal Triglyceride Transfer Protein Inhibitor [EPC],Microsomal Triglyceride Transfer Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 76431-120_87ea13fc-984a-416c-9411-a84d9c0e12b4 76431-120 HUMAN PRESCRIPTION DRUG Juxtapid lomitapide mesylate CAPSULE ORAL 20130103 NDA NDA203858 Aegerion Pharmaceuticals, Inc. LOMITAPIDE MESYLATE 20 mg/1 Microsomal Triglyceride Transfer Protein Inhibitor [EPC],Microsomal Triglyceride Transfer Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 76431-130_87ea13fc-984a-416c-9411-a84d9c0e12b4 76431-130 HUMAN PRESCRIPTION DRUG Juxtapid lomitapide mesylate CAPSULE ORAL 20130103 NDA NDA203858 Aegerion Pharmaceuticals, Inc. LOMITAPIDE MESYLATE 30 mg/1 Microsomal Triglyceride Transfer Protein Inhibitor [EPC],Microsomal Triglyceride Transfer Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 76431-140_87ea13fc-984a-416c-9411-a84d9c0e12b4 76431-140 HUMAN PRESCRIPTION DRUG Juxtapid lomitapide mesylate CAPSULE ORAL 20130103 NDA NDA203858 Aegerion Pharmaceuticals, Inc. LOMITAPIDE MESYLATE 40 mg/1 Microsomal Triglyceride Transfer Protein Inhibitor [EPC],Microsomal Triglyceride Transfer Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 76431-160_87ea13fc-984a-416c-9411-a84d9c0e12b4 76431-160 HUMAN PRESCRIPTION DRUG Juxtapid lomitapide mesylate CAPSULE ORAL 20130103 NDA NDA203858 Aegerion Pharmaceuticals, Inc. LOMITAPIDE MESYLATE 60 mg/1 Microsomal Triglyceride Transfer Protein Inhibitor [EPC],Microsomal Triglyceride Transfer Protein Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA] N 20181231 76431-210_a021117a-7363-4403-92e6-344b94cab4b0 76431-210 HUMAN PRESCRIPTION DRUG Myalept metreleptin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUBCUTANEOUS 20150305 BLA BLA125390 Aegerion Pharmaceuticals, Inc. METRELEPTIN 11.3 mg/2.2mL Leptin Analog [EPC],Analogs/Derivatives [Chemical/Ingredient],Leptin [Chemical/Ingredient] N 20181231 76433-002_39e3807c-deb1-4274-9950-ad65b8776ce3 76433-002 HUMAN OTC DRUG Tapout Muscle Recovery Rapid Pain Relief Camphor SPRAY TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part348 Revive Bioscience, Inc. CAMPHOR (SYNTHETIC) 1 mL/30mL N 20181231 76433-003_66e67e18-4ec4-4c88-91a1-11c9e91d737d 76433-003 HUMAN OTC DRUG TapouT Muscle Recovery Camphor CLOTH TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part348 Revive Bioscience, Inc. CAMPHOR (SYNTHETIC) 1 mL/1 N 20181231 76433-004_9e334bf4-0401-432d-8403-b73f21e679cb 76433-004 HUMAN OTC DRUG O24 Essential Oil Pain Relieving Camphor SPRAY TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part348 Revive Bioscience, Inc. CAMPHOR (SYNTHETIC) 1 mL/30mL N 20181231 76433-005_0e7ddd10-34a5-4e0b-ae7f-528346e5eb7a 76433-005 HUMAN OTC DRUG O24 Essential Oil Pain Relieving Camphor CLOTH TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part348 Revive Bioscience, Inc. CAMPHOR (SYNTHETIC) 1 mL/1 N 20181231 76436-138_00c54551-bdd3-41d9-a32f-6a2794d7a38c 76436-138 HUMAN OTC DRUG Sof Skin Baby Petroleum Petrolatum JELLY TOPICAL 20171127 OTC MONOGRAPH FINAL part347 Viny Health and Beauty Inc PETROLATUM 99.9 g/100g N 20181231 76436-139_b4eb91e1-ad07-4470-997e-1415f6f42135 76436-139 HUMAN OTC DRUG Sof Skin Pure Petroleum Cocoa Butter Petrolatum JELLY TOPICAL 20171127 OTC MONOGRAPH FINAL part347 Viny Health and Beauty Inc PETROLATUM 99.9 g/100g N 20181231 76436-233_39c2fd8e-b651-4df1-a420-24101c00ae7f 76436-233 HUMAN OTC DRUG NATURES REALM COOL HOT ICE ANALGESIC Menthol GEL TOPICAL 20180130 OTC MONOGRAPH FINAL part341 Viny Health and Beauty Inc MENTHOL 1 g/100g N 20191231 76436-306_82eea19d-43b3-4746-91c7-b8fff83d3a35 76436-306 HUMAN OTC DRUG RUBBING ALCOHOL 99 PERCENT ISOPROPYL ALCOHOL LIQUID TOPICAL 20171107 OTC MONOGRAPH NOT FINAL part333A Viny Health and Beauty Products Inc ISOPROPYL ALCOHOL 99 mL/100mL N 20181231 76436-307_917ef6e7-6fa4-4ed6-a9a9-aa223e469b4d 76436-307 HUMAN OTC DRUG RUBBING ALCOHOL 99 PERCENT with Wintergreen ISOPROPYL ALCOHOL LIQUID TOPICAL 20141203 OTC MONOGRAPH NOT FINAL part333A Viny Health and Beauty Products Inc ISOPROPYL ALCOHOL 99 mL/100mL N 20181231 76436-308_bb4b2e26-f234-441f-a6fd-1c417e23079f 76436-308 HUMAN OTC DRUG RUBBING ALCOHOL 70 PERCENT ISOPROPYL ALCOHOL LIQUID TOPICAL 20171130 OTC MONOGRAPH NOT FINAL part333A Viny Health and Beauty Products Inc ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 76436-309_dea95add-506d-43bf-8ea2-c133c6f444ce 76436-309 HUMAN OTC DRUG WISE SHOPPER RUBBING ALCOHOL 50 PERCENT with Wintergreen ISOPROPYL ALCOHOL LIQUID TOPICAL 20171130 OTC MONOGRAPH NOT FINAL part333A Viny Health and Beauty Products Inc ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 76436-310_e9d70259-533e-4e54-b453-b81cadce8981 76436-310 HUMAN OTC DRUG WISE SHOPPER RUBBING ALCOHOL 50 PERCENT ISOPROPYL ALCOHOL LIQUID TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part333A Viny Health and Beauty Products Inc ISOPROPYL ALCOHOL 50 mL/100mL N 20181231 76436-311_9e3088bd-ef11-493a-b833-4b5d3683e7cc 76436-311 HUMAN OTC DRUG MED-PRIDE ISOPROPYL RUBBING ALCOHOL 70 PERCENT with Wintergreen ISOPROPYL ALCOHOL LIQUID TOPICAL 20171130 OTC MONOGRAPH NOT FINAL part333A Viny Health and Beauty Products Inc ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 76437-609_29f3069a-f2e2-4368-9698-d8b87fb3b8e9 76437-609 HUMAN OTC DRUG Reed Therapeutics Pain Relieving Therapy Methyl Salicylate, Menthol USP, Camphor GEL TOPICAL 20130109 OTC MONOGRAPH NOT FINAL part356 Reed Therapeutics METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 12.5; 4; .2 g/100g; g/100g; g/100g E 20171231 76437-609_bfbc2af5-0f4b-46cc-aae4-44d25994b14d 76437-609 HUMAN OTC DRUG Reed Therapeutics Pain Relieving Therapy Methyl Salicylate, Menthol USP, Camphor GEL TOPICAL 20130323 OTC MONOGRAPH NOT FINAL part356 Reed Therapeutics METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 12.5; 4; .2 g/100g; g/100g; g/100g E 20171231 76437-609_f1f6551d-a099-427f-a223-79a6151523ee 76437-609 HUMAN OTC DRUG Reed Therapeutics Pain Relieving Therapy Methyl Salicylate, Menthol USP, Camphor GEL TOPICAL 20130329 OTC MONOGRAPH NOT FINAL part356 Reed Therapeutics METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC) 12.5; 4; .2 g/100g; g/100g; g/100g E 20171231 76439-205_a2ca9d47-8705-4817-94fd-4c64a13a2cb7 76439-205 HUMAN PRESCRIPTION DRUG L-Methylfolate Calcium LEVOMEFOLATE CALCIUM TABLET, COATED ORAL 20120315 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LEVOMEFOLATE CALCIUM 15 mg/1 E 20171231 76439-205_e6543530-df14-4d6a-b513-169387dd5513 76439-205 HUMAN PRESCRIPTION DRUG L-Methyl-B6-B12 Levomefolate Calcium, Pyridoxal 5-Phosphate, and Methylcobalamin TABLET, COATED ORAL 20120315 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LEVOMEFOLATE CALCIUM; PYRIDOXAL 5-PHOSPHATE; METHYLCOBALAMIN 15; 35; 2 mg/1; mg/1; mg/1 E 20171231 76439-233_8b23f206-43eb-454b-9608-b9cb985209cd 76439-233 HUMAN PRESCRIPTION DRUG VP-GGR-B6 pyridoxine hydrochloride, folic acid, calcium phosphate, dibasic, anhydrous, tricalcium phosphate and ginger TABLET ORAL 20130613 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS; TRICALCIUM PHOSPHATE; GINGER 40; 1.2; 62.05; 62.05; 100 mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Non-Standardized Plant Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [Chemical/Ingredient],Dietary Proteins [Chemical/Ingredient],Plant Proteins [Chemical/Ingredient],Food Additives [Chemical/Ingredient] N 20181231 76439-251_fa15c346-efc0-4f83-b729-413984bb4639 76439-251 HUMAN PRESCRIPTION DRUG Extra-Virt Plus DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, biotin, calcium carbonate, docusate calcium, ferrous fumarate and doconexent CAPSULE, GELATIN COATED ORAL 20121228 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, D-; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; BIOTIN; CALCIUM CARBONATE; DOCUSATE CALCIUM; FERROUS FUMARATE; DOCONEXENT 28; 800; 30; 25; 1.25; 250; 158; 55; 29; 350 mg/1; [iU]/1; [iU]/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient] E 20171231 76439-261_a781b3ec-f20d-47d2-b696-06d44522ba52 76439-261 HUMAN PRESCRIPTION DRUG Potassium Citrate Citric Acid Crystals Potassium Citrate and Citric Acid GRANULE, FOR SOLUTION ORAL 20140613 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC POTASSIUM CITRATE; CITRIC ACID MONOHYDRATE 3.3; 1.002 g/1; g/1 Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 76439-273_0f8e6147-cffc-4a22-b644-d049d8c698b3 76439-273 HUMAN PRESCRIPTION DRUG PNV Ferrous Fumarate Docusate Folic Acid PNV Ferrous Fumarate Docusate Folic Acid TABLET ORAL 20140422 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals LLC .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; DOCUSATE SODIUM 1000; 100; 400; 30; 3; 3; 15; 20; 1; 12; 7; 200; 29; 20; 25 [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1 Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE] E 20171231 76439-302_6d696c94-e039-44e8-830a-3790c2c168f9 76439-302 HUMAN PRESCRIPTION DRUG Chlordiazepoxide Hydrochloride/Clidinium Bromide Chlordiazepoxide Hydrochloride and Clidinium Bromide CAPSULE ORAL 20120608 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 5; 2.5 mg/1; mg/1 Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA] N 20181231 76439-307_59c9dd21-a06a-418d-acaf-3543cc490812 76439-307 HUMAN PRESCRIPTION DRUG hyoscyamine sulfate hyoscyamine sulfate TABLET, ORALLY DISINTEGRATING ORAL 20110904 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals HYOSCYAMINE SULFATE .125 mg/1 N 20181231 76439-308_294d6aef-0c5a-4e96-bded-fcac0cef8363 76439-308 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate Hyoscyamine Sulfate TABLET ORAL 20110904 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals HYOSCYAMINE SULFATE .125 mg/1 N 20181231 76439-309_efe5460a-1d0c-44f5-be5d-ba5bfc921f99 76439-309 HUMAN PRESCRIPTION DRUG Hyoscyamine Sulfate SL Hyoscyamine Sulfate TABLET ORAL 20110904 UNAPPROVED DRUG OTHER Virtus Pharmaceuticals HYOSCYAMINE SULFATE .125 mg/1 N 20181231 76441-902_7cd2f3b6-3b50-4a00-99d5-86d7dd298efa 76441-902 HUMAN OTC DRUG Licel Piperonly Butoxide, Pyrethrum Extract OIL TOPICAL 20120620 OTC MONOGRAPH FINAL part358G Sujanil Chemo Industries PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 mL/100mL; mL/100mL E 20171231 76441-903_dbfbc2a6-6e3b-4aff-bf91-3747563a1f5a 76441-903 HUMAN OTC DRUG Lice-Nil Lice and Eggs Killer Piperonly Butoxide, Pyrethrum Extract OIL TOPICAL 20130618 OTC MONOGRAPH FINAL part358G Sujanil Chemo Industries PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 4; .33 g/100mL; g/100mL E 20171231 76441-904_1c44f814-8491-0e79-e054-00144ff88e88 76441-904 HUMAN OTC DRUG Lice-Nil Lice and Eggs Eliminator NEEM OIL, TEA TREE OIL OIL TOPICAL 20150731 UNAPPROVED HOMEOPATHIC Sujanil Chemo Industries AZADIRACHTA INDICA SEED OIL; TEA TREE OIL 5; 3 [hp_X]/100mL; [hp_X]/100mL E 20171231 76441-909_203deaf1-2712-4604-bc81-8dc793596f5d 76441-909 HUMAN OTC DRUG Lice-Nil LICE AND EGGS ELIMINATOR Oil AZADIRACHTA INDICA OIL TOPICAL 20170801 UNAPPROVED HOMEOPATHIC Sujanil Chemo Industries AZADIRACHTA INDICA SEED OIL 1 [hp_X]/100mL N 20181231 76445-0091_61d79a68-4f45-c585-e053-2a91aa0ab267 76445-0091 HUMAN OTC DRUG Clear-N-Smooth Acne-Pimple Medication LOTION TOPICAL 19920102 OTC MONOGRAPH FINAL part333D Hawknad Manufacturing Industries, Inc. SALICYLIC ACID .01 g/g N 20191231 76446-001_27b238db-0a0e-4591-8668-6ca1d2ef6ab7 76446-001 HUMAN OTC DRUG Anna Lotan Triple Benefit Tinted Moisturizing Day Broad Spectrum SPF 30 OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20120119 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE 7.5; 6.65; 2.5 mL/100mL; mL/100mL; mL/100mL E 20171231 76446-002_1d1b99c6-cf1a-4c46-bf5b-90b8e43c07c3 76446-002 HUMAN OTC DRUG ANNA LOTAN Premium B.B. UVA UVB SPF 36 TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20120616 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd TITANIUM DIOXIDE; OCTINOXATE 30; 15 mL/100mL; mL/100mL N 20181231 76446-003_a541893c-e891-4f26-adbb-a7e9da4b341b 76446-003 HUMAN OTC DRUG ANNA LOTAN Clear Protector Free Broad Spectrum SPF 32 Sunscreen HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE GEL TOPICAL 20120616 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE 7.5; 5; 4; 3; 2.75 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL E 20171231 76446-004_61941da9-5d7e-3786-e053-2a91aa0a709a 76446-004 HUMAN OTC DRUG ANNA LOTAN Rejuvenating Day Broad Spectrum SPF 34 OCTINOXATE, TITANIUM DIOXIDE CREAM TOPICAL 20120619 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; TITANIUM DIOXIDE 7.5; 4.4 mg/100mL; mg/100mL N 20191231 76446-006_6156327d-da68-e51c-e053-2a91aa0a1222 76446-006 HUMAN OTC DRUG anna lotan PRO PORCELAIN COVER SPF32 Tinted with Broad Spectrum Protection for All Skin Types TITANIUM DIOXIDE, OCTINOXATE LOTION TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd TITANIUM DIOXIDE; OCTINOXATE 134; 75 mg/mL; mg/mL N 20181231 76446-007_1e6a2703-6fdb-4e1d-9887-afb0c2a2a569 76446-007 HUMAN OTC DRUG anna lotan PRO Protective LIGHTENING CARE UVA/UVB SPF 15 For Sun Damaged Skin OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM TOPICAL 20131111 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE 70; 30; 21 mg/mL; mg/mL; mg/mL E 20171231 76446-008_33335cf4-3bb2-70c8-e054-00144ff8d46c 76446-008 HUMAN OTC DRUG Extreme (UVA/UVB) SPF 33 ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENE CREAM TOPICAL 20160519 OTC MONOGRAPH NOT FINAL part352 Anna Lotan Ltd. OCTINOXATE; AVOBENZONE; OCTOCRYLENE 75; 30; 28 mg/mL; mg/mL; mg/mL E 20171231 76446-009_33334e24-8f5a-1fc2-e054-00144ff8d46c 76446-009 HUMAN OTC DRUG Tinted Day (UVA/UVB) SPF 34 ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, OXYBENZONE CREAM TOPICAL 20160519 OTC MONOGRAPH NOT FINAL part352 Anna Lotan Ltd. OCTINOXATE; TITANIUM DIOXIDE; OXYBENZONE 75; 66.5; 25 mg/mL; mg/mL; mg/mL E 20171231 76446-011_610a6f19-716f-2907-e053-2a91aa0a44b5 76446-011 HUMAN OTC DRUG Premium BB Cream UVA/UVB SPF36 0 Pale TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20160902 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd TITANIUM DIOXIDE; OCTINOXATE 4.5; 2.1 g/30mL; g/30mL N 20181231 76446-012_610a6f19-717c-2907-e053-2a91aa0a44b5 76446-012 HUMAN OTC DRUG Premium BB Cream UVA/UVB SPF36 1 Natural TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20160902 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd TITANIUM DIOXIDE; OCTINOXATE 4.5; 2.1 g/30mL; g/30mL N 20181231 76446-013_610a6f19-7189-2907-e053-2a91aa0a44b5 76446-013 HUMAN OTC DRUG Premium BB Cream UVA/UVB SPF36 2 Beige TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20160902 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd TITANIUM DIOXIDE; OCTINOXATE 4.5; 2.1 g/30mL; g/30mL N 20181231 76446-014_610a6f19-7196-2907-e053-2a91aa0a44b5 76446-014 HUMAN OTC DRUG Premium BB Cream UVA/UVB SPF36 3 Medium TITANIUM DIOXIDE, OCTINOXATE CREAM TOPICAL 20160902 OTC MONOGRAPH FINAL part352 Anna Lotan Ltd TITANIUM DIOXIDE; OCTINOXATE 4.5; 2.1 g/30mL; g/30mL N 20181231 76449-050_8d673888-8afe-4340-a182-05dfedc64ece 76449-050 HUMAN OTC DRUG Blemish Control Blotting Paper Salicylic Acid STRIP TOPICAL 20111215 OTC MONOGRAPH FINAL part358H NYX Los Angeles Inc. SALICYLIC ACID .03 mg/1 E 20171231 76450-050_fbc5a4ec-466f-476f-97d5-4e86c0e5f660 76450-050 HUMAN OTC DRUG MOISTURISING SUN PROTECTION SPF50 OCTINOXATE LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Mesoestetic, S.L. OCTINOXATE; ENZACAMENE; AVOBENZONE; ENSULIZOLE 3; 1.5; 1.5; 1 mL/50mL; mL/50mL; mL/50mL; mL/50mL N 20181231 76450-051_2a6178b0-752d-4ebd-ab95-2c002b5d5616 76450-051 HUMAN OTC DRUG DERMATOLOGICAL SUN PROTECTION OCTINOXATE LOTION TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 Mesoestetic, S.L. OCTINOXATE; TITANIUM DIOXIDE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE; ENSULIZOLE 3.75; 3.5; 3; 2; 1.75; 1.5 mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL; mL/50mL N 20181231 76450-052_20eecf59-b091-4131-869d-e2fb6d5934f0 76450-052 HUMAN OTC DRUG mesoestetic moisturizing sun protection BROAD SPECTRUM FOR NORMAL AND DRY SKINS avobenzone, ensulizole, enzacamene, octinoxate CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MESOESTETIC, S.L. AVOBENZONE; ENSULIZOLE; ENZACAMENE; OCTINOXATE 1.5; 1; 1.5; 3 g/50mL; g/50mL; g/50mL; g/50mL N 20181231 76450-053_8385bfd9-cfc3-4cbe-aa07-66938f0c2291 76450-053 HUMAN OTC DRUG mesoestetic DERMATOLOGICAL SUN PROTECTION BROAD SPECTRUM avobenzone, benzophenone-3, ensulizole, octocrylene, octinoxate, titanium dioxide CREAM TOPICAL 20120201 OTC MONOGRAPH NOT FINAL part352 MESOESTETIC, S.L. AVOBENZONE; ENSULIZOLE; OXYBENZONE; OCTINOXATE; TITANIUM DIOXIDE; OCTOCRYLENE 1.5; 1; 2; 3.75; 4.47; 3 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL N 20181231 76452-001_d2e425f0-6031-4ba8-9b3a-49298b96570b 76452-001 HUMAN OTC DRUG Zaliex ALCOHOL-FREE Antiseptic Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333E SAS Healthcare Inc BENZALKONIUM CHLORIDE .13 mL/100mL N 20181231 76452-002_7318b746-f215-4ac9-9d0e-d2a71658134f 76452-002 HUMAN OTC DRUG Zaliex Antiseptic Hand BENZALKONIUM CHLORIDE SOAP TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333E SAS Healthcare Inc BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 76452-003_170f4fa5-da5d-4caf-8a7b-8f5ebfd00445 76452-003 HUMAN OTC DRUG Zaliex Alcohol-Free Antiseptic Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20120913 OTC MONOGRAPH NOT FINAL part333E SAS Healthcare Inc BENZALKONIUM CHLORIDE .13 mg/mL N 20181231 76452-004_2b543a16-e2bf-4b00-822e-01326f57cd0e 76452-004 HUMAN OTC DRUG Zaliex Alcohol-Free Foaming Hand Sanitizer BENZALKONIUM CHLORIDE LIQUID TOPICAL 20111026 OTC MONOGRAPH NOT FINAL part333E SAS Healthcare Inc BENZALKONIUM CHLORIDE .1 mg/.001L N 20181231 76454-100_698fa2f5-9044-430a-a8a0-aed3d056bd53 76454-100 HUMAN OTC DRUG NATURES GUM BALM SODIUM MONOFLUOROPHOSPHATE PASTE DENTAL 20111001 20181001 OTC MONOGRAPH FINAL part355 Widepipe Corp SODIUM MONOFLUOROPHOSPHATE 8.4 mg/g E 20171231 76454-101_8fa43213-34bb-4291-9560-ed59d4daf16b 76454-101 HUMAN OTC DRUG NATURES SMILE SODIUM FLUORIDE MOUTHWASH DENTAL 20111001 20181001 OTC MONOGRAPH FINAL part355 Widepipe Corp SODIUM FLUORIDE .2 mg/mL E 20171231 76457-001_943e1fc5-dee8-435c-981a-c87c09aea5aa 76457-001 HUMAN OTC DRUG Aluminum hydroxide and Magnesium carbonate ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE TABLET, CHEWABLE ORAL 20121115 OTC MONOGRAPH FINAL part331 Simpex Pharma Pvt. Ltd ALUMINUM HYDROXIDE; MAGNESIUM CARBONATE 160; 105 mg/1; mg/1 E 20171231 76457-002_02ac9591-9bec-49ef-8751-feb461860024 76457-002 HUMAN OTC DRUG diphenhydramine hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE TABLET ORAL 20121115 OTC MONOGRAPH FINAL part341 Simpex Pharma Pvt. Ltd DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1 E 20171231 76457-003_c31b1400-a62b-4319-84ff-f76c5e86b3b9 76457-003 HUMAN OTC DRUG SIMPEX Bisacodyl laxative BISACODYL TABLET, COATED ORAL 20131107 OTC MONOGRAPH NOT FINAL part334 Simpex Pharma Pvt. Ltd BISACODYL 5 mg/1 E 20171231 76457-004_32ab94e5-e61a-4831-97aa-42e92840da7e 76457-004 HUMAN OTC DRUG SIMPEX Guaifenesin GUAIFENESIN TABLET ORAL 20131107 OTC MONOGRAPH FINAL part341 Simpex Pharma Pvt. Ltd GUAIFENESIN 400 mg/1 E 20171231 76458-201_05a63c49-1974-4b26-b070-b32813cb0852 76458-201 HUMAN OTC DRUG Light Day Sunscreen Broad Spectrum SPF 37 Avobenzone, Octinoxate and Octocrylene LOTION TOPICAL 20120715 OTC MONOGRAPH NOT FINAL part352 Circadia by Dr Pugliese, Inc. AVOBENZONE; OCTINOXATE; OCTOCRYLENE .03; .075; .028 mL/mL; mL/mL; mL/mL E 20171231 76458-333_fb4cc832-4cfd-4e29-a78e-ab848681a224 76458-333 HUMAN OTC DRUG Nighttime Control Benzoyl Peroxide LOTION TOPICAL 20120715 OTC MONOGRAPH NOT FINAL part333D Circadia by Dr Pugliese, Inc. BENZOYL PEROXIDE .05 mL/mL E 20171231 76461-915_27307377-563a-2e3a-e054-00144ff88e88 76461-915 HUMAN OTC DRUG SMITH BROS BLACK LICORICE Throat Drops PECTIN LOZENGE ORAL 20130523 OTC MONOGRAPH NOT FINAL part356 Universal holdings I LLC dba Smith Brothers Company PECTIN 1.7 mg/1 E 20171231 76463-585_88a9eb0a-d10f-4060-9f3c-e06187864c3e 76463-585 HUMAN OTC DRUG Foam Aid ALCOHOL LIQUID TOPICAL 20111001 OTC MONOGRAPH NOT FINAL part333E Gil Manufacturing, Inc. ALCOHOL .62 mL/mL E 20171231 76464-001_c4b4600a-351e-4593-9f26-090a05ef78b9 76464-001 HUMAN OTC DRUG Chopper Chap Lip Balm Octinoxate, Oxybenzone STICK TOPICAL 20060408 OTC MONOGRAPH NOT FINAL part352 Cruising Chrome Cosmetics, LLC OCTINOXATE; OXYBENZONE 70; 30 mg/g; mg/g E 20171231 76466-010_ddcf6841-8afb-4e53-81e0-8cd30a628837 76466-010 HUMAN OTC DRUG VAGI-CURE (MAXIMUM STRENGTH) BENZOCAINE, RESORCINOL CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part348 SCI International, Inc. DBA Continental Pharmaceuticals BENZOCAINE; RESORCINOL 200; 30 mg/g; mg/g N 20191231 76466-011_36a96992-0a6a-1323-e054-00144ff88e88 76466-011 HUMAN OTC DRUG Vagi-Cure Advanced Sensitive Medicated BENZOCAINE, BENZALKONIUM CHLORIDE CREAM TOPICAL 20160630 OTC MONOGRAPH NOT FINAL part348 SCI International, Inc. DBA Continental Pharmaceuticals BENZOCAINE; BENZALKONIUM CHLORIDE 5; .13 g/100g; g/100g N 20181231 76466-075_caa8ffd8-895a-46f9-8e89-2b408b336a9f 76466-075 HUMAN OTC DRUG VAGI-CURE (REGULAR STRENGTH) BENZOCAINE, BENZALKONIUM CHLORIDE CREAM TOPICAL 20110101 OTC MONOGRAPH NOT FINAL part348 SCI International, Inc. DBA Continental Pharmaceuticals BENZOCAINE; BENZALKONIUM CHLORIDE 50; .13 mg/g; mg/g N 20191231 76466-500_e23ec086-c370-486f-85bf-0d9fe35eaca4 76466-500 HUMAN OTC DRUG Well at Walgreens Anti-Itch Maximum Strength Benzocaine and Resorcinol CREAM TOPICAL 20140519 OTC MONOGRAPH FINAL part346 SCI International BENZOCAINE; RESORCINOL 200; 30 mg/g; mg/g N 20191231 76468-121_460dfdb8-48a4-4980-9180-a47a55047068 76468-121 HUMAN OTC DRUG REZIL CAPSAICIN LOTION TOPICAL 20111101 OTC MONOGRAPH NOT FINAL part348 Toqara, Inc. CAPSAICIN .025 mL/100mL E 20171231 76470-002_2c7f4b5f-07b5-48b0-9f90-d71ffb2cebbb 76470-002 HUMAN OTC DRUG EZ2go Stimu-Lax MAGNESIUM CITRATE POWDER, FOR SOLUTION ORAL 20111101 OTC MONOGRAPH FINAL part331 Valley Medical Products, LLC MAGNESIUM CITRATE 17 g/17g E 20171231 76470-003_ae774fac-70e1-4e66-858b-acd1cbdafa0d 76470-003 HUMAN OTC DRUG EZ2go Zero DIMETHICONE TABLET ORAL 20111101 OTC MONOGRAPH FINAL part332 Valley Medical Products, LLC DIMETHICONE 80 mg/1 E 20171231 76470-004_4c6d1760-38d1-462d-a339-b753ba6f4ee9 76470-004 HUMAN OTC DRUG EZ2go Stimu-Lax BISACODYL TABLET ORAL 20120401 OTC MONOGRAPH NOT FINAL part334 Valley Medical Products, LLC BISACODYL 5 mg/5mg E 20171231 76470-005_44501029-845e-4428-a6b0-4031c6bfdc58 76470-005 HUMAN OTC DRUG EZ2go POLYETHYLENE GLYCOL 3350 POWDER ORAL 20121020 ANDA ANDA091077 Valley Medical Products,LLC POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 76470-006_478a9106-fe9d-4c83-9b7f-4acf06797125 76470-006 HUMAN OTC DRUG EZ2go PEG 3350 POLYETHYLENE GLYCOL 3350 POWDER ORAL 20121020 ANDA ANDA091077 Valley Medical Products,LLC POLYETHYLENE GLYCOL 3350 17 g/17g N 20181231 76470-010_46542eb5-cac5-478f-bafa-05cfa0236d55 76470-010 HUMAN OTC DRUG EZ2go Bisacodyl PILL ORAL 20150101 OTC MONOGRAPH NOT FINAL part334 Valley Medical Products,LLC BISACODYL 5 mg/5mg E 20171231 76470-011_28d15e11-d886-43b9-b50f-63adf496eddf 76470-011 HUMAN OTC DRUG EZ2go Bisacodyl PILL ORAL 20150101 OTC MONOGRAPH NOT FINAL part334 Valley Medical Products,LLC BISACODYL 5 mg/5mg E 20171231 76470-012_622aa381-d7f6-4325-b967-3186f234d0fd 76470-012 HUMAN OTC DRUG ez2go DIMETHICONE TABLET, CHEWABLE ORAL 20150101 OTC MONOGRAPH FINAL part332 Valley Medical Products,LLC DIMETHICONE 80 mg/80mg E 20171231 76470-020_85393371-4783-4545-8f5e-aecd6dff1868 76470-020 HUMAN OTC DRUG EZ2go POLYETHYLENE GLYCOL 3350 POWDER ORAL 20121020 ANDA ANDA091077 Valley Medical Products,LLC POLYETHYLENE GLYCOL 3350 17 g/17g E 20171231 76472-1123_e7862e97-4ea6-4d6b-bccb-c8b4906ee854 76472-1123 HUMAN OTC DRUG ACONITUM NAPELLUS ACONITUM NAPELLUS PELLET SUBLINGUAL 20111212 20190126 UNAPPROVED HOMEOPATHIC BrandStorm HBC ACONITUM NAPELLUS 30 [hp_C]/1 N 20181231 76472-1124_c697bb0f-1873-4e47-a0e6-7673cb705a52 76472-1124 HUMAN OTC DRUG Allium Cepa Allium Cepa PELLET SUBLINGUAL 20111120 20190616 UNAPPROVED HOMEOPATHIC BrandStorm HBC ONION 30 [hp_C]/1 N 20181231 76472-1125_9b150d35-f367-49cf-8776-504a049cfed2 76472-1125 HUMAN OTC DRUG APIS MELLIFERA APIS MELLIFERA PELLET SUBLINGUAL 20111123 20190720 UNAPPROVED HOMEOPATHIC BrandStorm HBC APIS MELLIFERA 30 [hp_C]/1 N 20181231 76472-1126_4dba7544-cdaa-4b38-a40f-43a855912222 76472-1126 HUMAN OTC DRUG Argentum Nitricum SILVER NITRATE PELLET SUBLINGUAL 20111130 20191011 UNAPPROVED HOMEOPATHIC BrandStorm HBC SILVER NITRATE 30 [hp_C]/1 N 20181231 76472-1127_8e491b66-5157-4871-b90e-53d73bd18b6e 76472-1127 HUMAN OTC DRUG Arnica 12c ARNICA MONTANA PELLET SUBLINGUAL 20111130 20190826 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARNICA MONTANA 12 [hp_C]/1 N 20181231 76472-1128_424fe89d-453d-48b1-9759-c55ac86e8d5e 76472-1128 HUMAN OTC DRUG Arnica ARNICA MONTANA PELLET SUBLINGUAL 20111130 20190521 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARNICA MONTANA 200 [kp_C]/1 N 20181231 76472-1129_0edb68e7-4c14-41df-96e4-f9df3801dbbf 76472-1129 HUMAN OTC DRUG Arnica 30c ARNICA MONTANA PELLET SUBLINGUAL 20111130 20190505 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARNICA MONTANA 30 [hp_C]/1 N 20181231 76472-1130_47db522c-40ae-4e86-bac0-bd79c13f454c 76472-1130 HUMAN OTC DRUG Arnica ARNICA MONTANA PELLET SUBLINGUAL 20111130 20190825 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARNICA MONTANA 30 [hp_X]/1 N 20181231 76472-1131_8c0bb660-57a9-4d69-a6be-9c8a5c3da7fd 76472-1131 HUMAN OTC DRUG Arnica 6c ARNICA MONTANA PELLET SUBLINGUAL 20111130 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARNICA MONTANA 6 [hp_C]/1 N 20181231 76472-1132_cc4c65af-0162-442a-93f1-fa51d2a3bc5d 76472-1132 HUMAN OTC DRUG Arsenicum Album 30c ARSENIC TRIOXIDE PELLET SUBLINGUAL 20111130 20191015 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARSENIC TRIOXIDE 30 [hp_C]/1 N 20181231 76472-1133_87d0a7db-76b9-47bf-bb44-f1bd4384ee7f 76472-1133 HUMAN OTC DRUG Belladonna ATROPA BELLADONNA PELLET SUBLINGUAL 20111130 20190716 UNAPPROVED HOMEOPATHIC BrandStorm HBC ATROPA BELLADONNA 30 [hp_C]/1 N 20181231 76472-1134_c8410fd8-1b5e-4c17-80b0-b528ca360642 76472-1134 HUMAN OTC DRUG Borax SODIUM BORATE PELLET SUBLINGUAL 20111130 20191001 UNAPPROVED HOMEOPATHIC BrandStorm HBC SODIUM BORATE 30 [hp_C]/1 N 20181231 76472-1135_0c27e445-dca2-4f2f-bec5-f513b8687229 76472-1135 HUMAN OTC DRUG Bryonia Alba 30c BRYONIA ALBA ROOT PELLET SUBLINGUAL 20111122 20190223 UNAPPROVED HOMEOPATHIC BrandStorm HBC BRYONIA ALBA ROOT 30 [hp_C]/1 N 20181231 76472-1136_5394487b-f338-4dcc-b2a7-f7992820e505 76472-1136 HUMAN OTC DRUG Calcarea Carbonic 30c OYSTER SHELL CALCIUM CARBONATE, CRUDE PELLET SUBLINGUAL 20111122 20190409 UNAPPROVED HOMEOPATHIC BrandStorm HBC OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_C]/1 N 20181231 76472-1137_3bf20538-2a23-4f69-883d-9d0c833816f7 76472-1137 HUMAN OTC DRUG Calcarea Sulphurica 30c CALCIUM SULFATE ANHYDROUS PELLET SUBLINGUAL 20111122 20190129 UNAPPROVED HOMEOPATHIC BrandStorm HBC CALCIUM SULFATE ANHYDROUS 30 [hp_C]/1 N 20181231 76472-1138_8df79f54-0a60-4e2b-8c44-171e37e6970b 76472-1138 HUMAN OTC DRUG Cantharis 30c LYTTA VESICATORIA PELLET SUBLINGUAL 20111122 20190721 UNAPPROVED HOMEOPATHIC BrandStorm HBC LYTTA VESICATORIA 30 [hp_C]/1 N 20181231 76472-1139_0e2e7112-aeef-45d2-9a8a-73cd437d675e 76472-1139 HUMAN OTC DRUG Carbo Vegetabilis 30c ACTIVATED CHARCOAL PELLET SUBLINGUAL 20111122 20190218 UNAPPROVED HOMEOPATHIC BrandStorm HBC ACTIVATED CHARCOAL 30 [hp_C]/1 N 20181231 76472-1140_01a4c5ca-334d-411b-9098-7cdfe68c8798 76472-1140 HUMAN OTC DRUG Chamomilla 30c MATRICARIA RECUTITA PELLET SUBLINGUAL 20111124 20190719 UNAPPROVED HOMEOPATHIC BrandStorm HBC MATRICARIA RECUTITA 30 [hp_C]/1 N 20181231 76472-1141_0b26b7e8-cc69-490c-9d35-084274f5f681 76472-1141 HUMAN OTC DRUG Coffea Cruda 30c ARABICA COFFEE BEAN PELLET SUBLINGUAL 20111124 20190203 UNAPPROVED HOMEOPATHIC BrandStorm HBC ARABICA COFFEE BEAN 30 [hp_C]/1 N 20181231 76472-1142_f8344f8f-7a38-4ac8-b075-4bcf92436a76 76472-1142 HUMAN OTC DRUG Gelsemium Sempervirens 30c Gelsemium Sempervirens Root PELLET SUBLINGUAL 20111124 20190209 UNAPPROVED HOMEOPATHIC BrandStorm HBC GELSEMIUM SEMPERVIRENS ROOT 30 [hp_C]/1 N 20181231 76472-1143_46ead55d-4711-435a-b7ba-169d1cb5f4ca 76472-1143 HUMAN OTC DRUG Hamamelis Virginiana 30c HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK PELLET SUBLINGUAL 20111124 20190517 UNAPPROVED HOMEOPATHIC BrandStorm HBC HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 30 [hp_C]/1 N 20181231 76472-1144_57fa83c4-dfc3-4dcb-a7d7-c8e02b251f44 76472-1144 HUMAN OTC DRUG Hepar Sulphuris Calcareum 30c CALCIUM SULFIDE PELLET SUBGINGIVAL 20111124 20190129 UNAPPROVED HOMEOPATHIC BrandStorm HBC CALCIUM SULFIDE 30 [hp_C]/1 N 20181231 76472-1145_df7412c1-7f79-48df-bfab-b338ac835392 76472-1145 HUMAN OTC DRUG Histaminum Hydrochloricum HISTAMINE DIHYDROCHLORIDE PELLET SUBLINGUAL 20111201 20191005 UNAPPROVED HOMEOPATHIC BrandStorm HBC HISTAMINE DIHYDROCHLORIDE 30 [hp_C]/1 N 20181231 76472-1146_17a8e897-e1f5-4c30-9fd7-bd91bb50e38d 76472-1146 HUMAN OTC DRUG HYDRASTIS CANADENSIS GOLDENSEAL PELLET SUBLINGUAL 20111115 20190721 UNAPPROVED HOMEOPATHIC BrandStorm HBC GOLDENSEAL 30 [hp_C]/1 N 20181231 76472-1147_bad741c4-045a-49cf-b03d-5632f51b800d 76472-1147 HUMAN OTC DRUG Hypericum Perforatum 30c HYPERICUM PERFORATUM PELLET SUBLINGUAL 20111115 20190119 UNAPPROVED HOMEOPATHIC BrandStorm HBC HYPERICUM PERFORATUM 30 [hp_C]/1 N 20181231 76472-1148_c0f6bcb1-2844-4a40-9ec8-cd20be5dbf37 76472-1148 HUMAN OTC DRUG Ignatia Amara 30c STRYCHNOS IGNATII SEED PELLET SUBLINGUAL 20111130 20190910 UNAPPROVED HOMEOPATHIC BrandStorm HBC STRYCHNOS IGNATII SEED 30 [hp_C]/1 N 20181231 76472-1149_5bc347f8-b92b-40f2-9da6-02eaa72fe4e2 76472-1149 HUMAN OTC DRUG Kali Bichromicum 30c POTASSIUM DICHROMATE PELLET SUBLINGUAL 20111130 20190610 UNAPPROVED HOMEOPATHIC BrandStorm HBC POTASSIUM DICHROMATE 30 [hp_C]/1 N 20181231 76472-1150_9d67bfbf-bfc5-4a31-8c41-08123ca4b53a 76472-1150 HUMAN OTC DRUG Lachesis Mutus LACHESIS MUTA VENOM PELLET SUBLINGUAL 20111130 20190911 UNAPPROVED HOMEOPATHIC BrandStorm HBC LACHESIS MUTA VENOM 30 [hp_C]/1 N 20181231 76472-1151_1e06e4a6-d93d-481f-8b28-2f073257a809 76472-1151 HUMAN OTC DRUG Ledum Palustre 30c LEDUM PALUSTRE TWIG PELLET SUBLINGUAL 20111130 20190517 UNAPPROVED HOMEOPATHIC BrandStorm HBC LEDUM PALUSTRE TWIG 30 [hp_C]/1 N 20181231 76472-1152_c9cfe836-4c5e-4f4c-b53c-a92953ebf088 76472-1152 HUMAN OTC DRUG Lycopodium Clavatum LYCOPODIUM CLAVATUM SPORE PELLET SUBLINGUAL 20111130 20190723 UNAPPROVED HOMEOPATHIC BrandStorm HBC LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/1 N 20181231 76472-1153_c699f471-833d-41a7-b38a-33cda5b48c12 76472-1153 HUMAN OTC DRUG Mercurius Solubilis MERCURIUS SOLUBILIS PELLET SUBLINGUAL 20111130 20190618 UNAPPROVED HOMEOPATHIC BrandStorm HBC MERCURIUS SOLUBILIS 30 [hp_C]/1 N 20181231 76472-1154_e88f9421-fd21-497e-bf85-5f708b588c8a 76472-1154 HUMAN OTC DRUG Natrum Muriaticum SODIUM CHLORIDE PELLET SUBLINGUAL 20111130 20190618 UNAPPROVED HOMEOPATHIC BrandStorm HBC SODIUM CHLORIDE 30 [hp_C]/1 N 20181231 76472-1155_24bc26ee-e80c-447a-bbd1-b3c8a2dfc0f7 76472-1155 HUMAN OTC DRUG Nux Vomica STRYCHNOS NUX-VOMICA SEED PELLET SUBLINGUAL 20111130 20190422 UNAPPROVED HOMEOPATHIC BrandStorm HBC STRYCHNOS NUX-VOMICA SEED 30 [hp_C]/1 N 20181231 76472-1156_6bad252c-236c-4870-b413-361354178a0c 76472-1156 HUMAN OTC DRUG Phosphorus PHOSPHORUS PELLET SUBLINGUAL 20111130 20190223 UNAPPROVED HOMEOPATHIC BrandStorm HBC PHOSPHORUS 30 [hp_C]/1 N 20181231 76472-1157_66c8621f-0502-4f11-8bc8-f402c992fa1a 76472-1157 HUMAN OTC DRUG Phytolacca Decandra PHYTOLACCA AMERICANA ROOT PELLET SUBLINGUAL 20111130 20191029 UNAPPROVED HOMEOPATHIC BrandStorm HBC PHYTOLACCA AMERICANA ROOT 30 [hp_C]/1 N 20181231 76472-1158_55ed55dc-cbde-4541-84cc-0542323704d0 76472-1158 HUMAN OTC DRUG Pulsatilla PULSATILLA VULGARIS PELLET SUBLINGUAL 20111130 20190209 UNAPPROVED HOMEOPATHIC BrandStorm HBC PULSATILLA VULGARIS 30 [hp_C]/1 N 20181231 76472-1159_433223fc-ce0f-4d41-90a6-a73771d085b5 76472-1159 HUMAN OTC DRUG Rhus Toxicodendron TOXICODENDRON PUBESCENS LEAF PELLET SUBLINGUAL 20111130 20190720 UNAPPROVED HOMEOPATHIC BrandStorm HBC TOXICODENDRON PUBESCENS LEAF 30 [hp_C]/1 N 20181231 76472-1160_76eeadf8-71c9-4c29-b07a-1b60cdf535c6 76472-1160 HUMAN OTC DRUG Ruta Graveolens RUTA GRAVEOLENS PELLET SUBLINGUAL 20111130 20190602 UNAPPROVED HOMEOPATHIC BrandStorm HBC RUTA GRAVEOLENS FLOWERING TOP 30 [hp_C]/1 N 20181231 76472-1161_17c4bce1-0860-4f25-bbc6-c23b1ccd4279 76472-1161 HUMAN OTC DRUG Sepia 30c SEPIA OFFICINALIS JUICE PELLET SUBLINGUAL 20111108 20190521 UNAPPROVED HOMEOPATHIC BrandStorm HBC SEPIA OFFICINALIS JUICE 30 [hp_C]/1 N 20181231 76472-1162_08722725-a03a-4a2d-aee7-632d32cb39b5 76472-1162 HUMAN OTC DRUG Silicea SILICON DIOXIDE PELLET SUBLINGUAL 20111130 20190922 UNAPPROVED HOMEOPATHIC BrandStorm HBC SILICON DIOXIDE 30 [hp_C]/1 N 20181231 76472-1163_a5280dc5-a7fb-4067-9d2e-bc937795b602 76472-1163 HUMAN OTC DRUG Spongia Tosta SPONGIA OFFICINALIS SKELETON, ROASTED PELLET SUBLINGUAL 20111130 20190722 UNAPPROVED HOMEOPATHIC BrandStorm HBC SPONGIA OFFICINALIS SKELETON, ROASTED 30 [hp_C]/1 N 20181231 76472-1164_689a08d8-aff4-4a49-be69-c677bf57bd0c 76472-1164 HUMAN OTC DRUG Staphysagria DELPHINIUM STAPHISAGRIA SEED PELLET SUBLINGUAL 20111130 20190722 UNAPPROVED HOMEOPATHIC BrandStorm HBC DELPHINIUM STAPHISAGRIA SEED 30 [hp_C]/1 N 20181231 76472-1165_9ceced01-54c9-473e-bd19-9454277bc1eb 76472-1165 HUMAN OTC DRUG SULPHUR SULFUR PELLET SUBLINGUAL 20111115 20190402 UNAPPROVED HOMEOPATHIC BrandStorm HBC SULFUR 30 [hp_C]/1 N 20181231 76472-1166_1b42084a-4a60-469f-82bf-b5247cc9a338 76472-1166 HUMAN OTC DRUG Symphytum Officinale COMFREY ROOT PELLET SUBLINGUAL 20111115 20190929 UNAPPROVED HOMEOPATHIC BrandStorm HBC COMFREY ROOT 30 [hp_C]/1 N 20181231 76472-1167_f913ac1d-bcfd-4424-a318-13f89d5311f1 76472-1167 HUMAN OTC DRUG Thuja Occidentalis THUJA OCCIDENTALIS LEAFY TWIG PELLET SUBLINGUAL 20111115 20190719 UNAPPROVED HOMEOPATHIC BrandStorm HBC THUJA OCCIDENTALIS LEAFY TWIG 30 [hp_C]/1 N 20181231 76478-001_64db96c8-509a-45c5-b8cb-603d519699a6 76478-001 HUMAN PRESCRIPTION DRUG Betimol Timolol SOLUTION/ DROPS OPHTHALMIC 20140102 NDA NDA020439 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) (968937719) TIMOLOL 2.56 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 76478-002_64db96c8-509a-45c5-b8cb-603d519699a6 76478-002 HUMAN PRESCRIPTION DRUG Betimol Timolol SOLUTION/ DROPS OPHTHALMIC 20140102 NDA NDA020439 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) (968937719) TIMOLOL 5.12 mg/mL Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] N 20181231 76478-479_1a428a1c-fcf8-4c4c-a67c-aac5bc5348da 76478-479 HUMAN PRESCRIPTION DRUG Xylocaine Lidocaine Hydrochloride JELLY TOPICAL 20120701 NDA NDA008816 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) LIDOCAINE HYDROCHLORIDE .5 mg/18mL Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] N 20181231 76478-501_d2e78e41-8a39-42ca-a6a4-375b5db85635 76478-501 HUMAN PRESCRIPTION DRUG Nembutal Sodium pentobarbital sodium INJECTION INTRAMUSCULAR; INTRAVENOUS 19730919 ANDA ANDA083246 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) PENTOBARBITAL SODIUM 50 mg/mL CII N 20181231 76478-611_397f7ed4-3df4-4563-b6c0-0edc338c3375 76478-611 HUMAN PRESCRIPTION DRUG Cogentin benztropine mesylate INJECTION INTRAMUSCULAR; INTRAVENOUS 19590805 NDA NDA012015 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) BENZTROPINE MESYLATE 1 mg/mL Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA] N 20181231 76478-711_c737ac9e-7d80-45a7-b7bf-2374c0fbbb21 76478-711 HUMAN PRESCRIPTION DRUG Sodium Diuril chlorothiazide sodium INJECTION INTRAVENOUS 19581003 NDA NDA011145 Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) CHLOROTHIAZIDE SODIUM .5 mg/18mL Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient] N 20181231 76479-4403_f33bb874-d16e-4926-b066-a323b9b3c161 76479-4403 HUMAN OTC DRUG Eco.kid PIPERONYL BUTOXIDE SHAMPOO TOPICAL 20111001 OTC MONOGRAPH FINAL part358G Fravin Pty Ltd PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT 2; .17 mL/100mL; mL/100mL E 20171231 76482-013_2deddc27-52fd-4021-bb95-36862e4dfc22 76482-013 HUMAN OTC DRUG LEudine Anti-dandruff Pyrithione Zinc SHAMPOO TOPICAL 20130401 OTC MONOGRAPH FINAL part358H B&R Products Inc PYRITHIONE ZINC 1 g/100mL E 20171231 76484-948_55480e63-4b5c-4230-905b-5edfc1f7bb18 76484-948 HUMAN OTC DRUG 20/20 Topical Anesthetic BENZOCAINE STRIP DENTAL 20120228 OTC MONOGRAPH FINAL part356 Advanced Dental Anesthetics BENZOCAINE 10 mg/1 E 20171231 76485-1000_6ad836e5-3e2c-4f88-a3c7-1b704fdd6991 76485-1000 HUMAN OTC DRUG Moisture Renew Coral Shimmer (120) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1001_49ca4d03-ed54-4488-a1f8-34ee4e6f01e1 76485-1001 HUMAN OTC DRUG Moisture Renew Dreamy (140) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1002_c672f55a-9ecf-4ae9-af6a-1a437e6aeca7 76485-1002 HUMAN OTC DRUG Moisture Renew Pink Chic (220) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1003_c2a12fbc-9cc1-490f-b6ea-ab48dd3de2fd 76485-1003 HUMAN OTC DRUG Moisture Renew Pink Star (235) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1004_0d37a18a-520a-41cc-9d62-d7445daa0446 76485-1004 HUMAN OTC DRUG Moisture Renew Latino (240) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1005_c71c5065-3f28-4aad-a931-2b528ad4fe96 76485-1005 HUMAN OTC DRUG Moisture Renew Rose Blush (300) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1007_5cbeb24a-6012-4849-a62b-48c7999b2537 76485-1007 HUMAN OTC DRUG Moisture Renew Rose Shimmer (370) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1008_d7adcc9c-e1f1-4655-b618-8d77994a6154 76485-1008 HUMAN OTC DRUG Moisture Renew Vintage Pink (380) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1009_af10ab70-9d05-4f09-ab93-f8a7eafbd887 76485-1009 HUMAN OTC DRUG Moisture Renew Crystal Mauve (420) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1010_22312a94-eb3e-4091-98b7-e0c3584738db 76485-1010 HUMAN OTC DRUG Moisture Renew Mauve Pink (460) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1011_4515e12d-499c-439d-b22c-41936c27c02e 76485-1011 HUMAN OTC DRUG Moisture Renew Berry Rose (500) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1012_2eb02ce7-f1b3-44cd-ac7d-fa0e75696b29 76485-1012 HUMAN OTC DRUG Moisture Renew Violet Pop (520) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1013_0fd04a18-572e-40fb-a049-c7d8d6fdda57 76485-1013 HUMAN OTC DRUG Moisture Renew Burgundy Lustre (540) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1014_7d9a0153-7af9-4330-9e06-bef9618caac2 76485-1014 HUMAN OTC DRUG Moisture Renew Summer Angel (640) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1015_356fff2a-bc73-4a7e-b934-d5b1d58cd11a 76485-1015 HUMAN OTC DRUG Moisture Renew Nude Delight (642) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1016_9e7d2948-6a86-43fd-bce6-f62bd84040a1 76485-1016 HUMAN OTC DRUG Moisture Renew Dusty Rose (645) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1017_2392d607-fb9a-4980-bcf8-0ed7b66cb7b1 76485-1017 HUMAN OTC DRUG Moisture Renew Precious Brown (680) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1018_fcb84a41-1e1d-436b-92a8-63d8f78d20c6 76485-1018 HUMAN OTC DRUG Moisture Renew Iced Coffee (700) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1019_0bc82e46-2c87-4992-9b57-432100d4c51a 76485-1019 HUMAN OTC DRUG Moisture Renew Auburn Breeze (740) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1020_edf37953-6ed1-4705-b023-7d0508878330 76485-1020 HUMAN OTC DRUG Moisture Renew Cherrylicious (820) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1021_98443dfc-4f10-456f-86f8-062dfa60b0fe 76485-1021 HUMAN OTC DRUG Moisture Renew Burgundy Shine (840) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1022_29588ca6-3c9a-47ac-bf9b-c58888a02a7e 76485-1022 HUMAN OTC DRUG Moisture Renew Rouge (850) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1023_612d1a0d-66e6-4a64-95f1-0fa44901510e 76485-1023 HUMAN OTC DRUG Moisture Renew Red Alert (900) Octinoxate LIPSTICK TOPICAL 20111020 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTISALATE 300; 80 mg/4g; mg/4g N 20181231 76485-1024_0454a7fe-f85d-4ec5-a389-5359436537d9 76485-1024 HUMAN OTC DRUG Rimmel BB Beauty Balm Light Avobenzone, Octinoxate, Octisalate and Octocrylene LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .9; 1.2; 1.2; .6 mL/30mL; mL/30mL; mL/30mL; mL/30mL N 20181231 76485-1025_f4414210-3dae-4be5-819d-bf7e50fb26a8 76485-1025 HUMAN OTC DRUG Rimmel BB Beauty Balm Medium Avobenzone, Octinoxate, Octisalate and Octocrylene LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .9; 1.2; 1.2; .6 mL/30mL; mL/30mL; mL/30mL; mL/30mL N 20181231 76485-1026_e8275f1d-9373-4c7a-899e-ea0df170b96d 76485-1026 HUMAN OTC DRUG Rimmel BB Beauty Balm Medium Dark Avobenzone, Octinoxate, Octisalate and Octocrylene LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .9; 1.2; 1.2; .6 mL/30mL; mL/30mL; mL/30mL; mL/30mL N 20181231 76485-1027_db4ffd79-a6a8-4458-ac1b-8736d2f795fe 76485-1027 HUMAN OTC DRUG Match Perfection SPF 18 Classic Ivory 101 Octinoxate Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL E 20171231 76485-1028_4f72c004-b2b9-4cf0-9156-f5f91c33ee18 76485-1028 HUMAN OTC DRUG Match Perfection SPF 18 Light Nude 102 Octinoxate Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL E 20171231 76485-1029_8f129af1-dde9-4b94-8a70-f544b4f4983e 76485-1029 HUMAN OTC DRUG Match Perfection SPF 18 Ivory 120 Octinoxate and Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL E 20171231 76485-1030_90c712dd-72a4-497f-87ed-4e1a798bfd18 76485-1030 HUMAN OTC DRUG Match Perfection SPF 18 True Ivory 130 Octinoxate Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL E 20171231 76485-1031_0772dedd-cc81-4760-9a10-95cb7205cafa 76485-1031 HUMAN OTC DRUG Match Perfection SPF 18 Nude 202 Octinoxate Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL E 20171231 76485-1032_6c7b91dc-9751-41d7-8165-fa597dbc1b29 76485-1032 HUMAN OTC DRUG Match Perfection SPF 18 Soft Beige 240 Octinoxate Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL E 20171231 76485-1033_7a02b4e8-608e-4f5e-b86b-40341e0989f7 76485-1033 HUMAN OTC DRUG Match Perfection SPF 18 Classic Beige 250 Octinoxate and Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL E 20171231 76485-1034_b46c4c51-0fce-4aa7-97fe-d5f38eb9b870 76485-1034 HUMAN OTC DRUG Match Perfection SPF 18 Sand 330 Octinoxate Titanium Dioxide LIQUID TOPICAL 20120915 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.2; 1.5 mL/30mL; mL/30mL E 20171231 76485-1035_54439149-ec52-44c5-b2ce-d87c25311e41 76485-1035 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 Light Ivory Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. TITANIUM DIOXIDE; OCTINOXATE 2.9574; .8325 g/301mL; g/301mL N 20181231 76485-1036_ec8597fa-3641-4520-b88e-2aad855e2a9f 76485-1036 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 Ivory Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. TITANIUM DIOXIDE; OCTINOXATE 2.9574; .8325 g/301mL; g/301mL N 20181231 76485-1037_a02d12ac-68d6-429b-92aa-2cd2ed60d0b8 76485-1037 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 Classic Ivory Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. TITANIUM DIOXIDE; OCTINOXATE 2.9574; .8325 g/301mL; g/301mL N 20181231 76485-1038_ca5f29a1-06c0-417d-8b89-06db1a7ea7c4 76485-1038 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 Soft Beige Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. TITANIUM DIOXIDE; OCTINOXATE 2.9574; .8325 g/301mL; g/301mL N 20181231 76485-1039_71b3200d-5ce0-4cd4-a014-5ff6fdd92913 76485-1039 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 Classic Beige Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. TITANIUM DIOXIDE; OCTINOXATE 2.9574; .8325 g/301mL; g/301mL N 20181231 76485-1040_2428a126-dbba-4396-b7d7-29d4b06f9a5d 76485-1040 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 True Beige Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. TITANIUM DIOXIDE; OCTINOXATE 2.9574; .8325 g/301mL; g/301mL N 20181231 76485-1041_31d64730-5e73-4e86-a192-ebc7753ef8f8 76485-1041 HUMAN OTC DRUG Long Lasting Finish with Comfort Serum SPF 20 Sand Titanium Dioxide, Octinoxate LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. TITANIUM DIOXIDE; OCTINOXATE 2.9574; .8325 g/301mL; g/301mL N 20181231 76485-1042_284151c0-52f4-4130-8905-fa9f0f3de865 76485-1042 HUMAN OTC DRUG Rimmel BB Cream Beauty Balm Radiance SPF 20 Light Avobenzone, Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 1.008; 1.008; 1.344; 1.008 g/30mL; g/30mL; g/30mL; 1/30mL N 20181231 76485-1043_ab393b15-c976-4769-9cc1-2e9849474594 76485-1043 HUMAN OTC DRUG Rimmel BB Cream Beauty Balm Radiance SPF 20 Medium Avobenzone, Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE 1.008; 1.008; 1.344; 1.008 g/30mL; g/30mL; g/30mL; 1/30mL N 20181231 76485-1044_09f334bc-894b-4a52-88d9-62a9545909d1 76485-1044 HUMAN OTC DRUG Rimmel BB Cream Matte 9-IN-1 Skin Perfecting Super Makeup SPF 15 Light Octinoxate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTOCRYLENE 2.3; .3 g/30mL; g/30mL N 20181231 76485-1045_43060345-d87f-4002-bc49-0b5697e4cec9 76485-1045 HUMAN OTC DRUG Rimmel BB Cream Matte 9-IN-1 Skin Perfecting Super Makeup SPF 15 Light Octinoxate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTOCRYLENE 2.3; .3 g/30mL; g/30mL N 20181231 76485-1046_599b2097-6df7-44e0-8b2d-130c093e25fc 76485-1046 HUMAN OTC DRUG Rimmel BB Cream Matte 9-IN-1 Skin Perfecting Super Makeup SPF 15 Medium Dark Octinoxate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTOCRYLENE 2.3; .3 g/30mL; g/30mL N 20181231 76485-1047_8d11a6dd-290d-436a-9a1e-b167176a2ad9 76485-1047 HUMAN OTC DRUG Rimmel BB Cream Matte 9-IN-1 Skin Perfecting Super Makeup SPF 15 Light Medium Octinoxate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; OCTOCRYLENE 2.3; .3 g/30mL; g/30mL N 20181231 76485-1048_06d75389-4f47-4ab0-9320-53eba6cceb46 76485-1048 HUMAN OTC DRUG Rimmel BB Cream 9-IN-1 Skin Perfecting Super Makeup Light Medium Avobenzone, Octinoxate, Octisalate, Octocrylene LOTION TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .9; 1.3; 1.3; .6 g/30mL; g/30mL; g/30mL; 1/30mL N 20181231 76485-1050_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1050 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 100 Ivory Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1051_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1051 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 101 Classic Ivory Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1052_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1052 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 102 Light Nude Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1053_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1053 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 103 True Ivory Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1054_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1054 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 200 Beige Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1055_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1055 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 201 Classic Beige Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1056_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1056 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 202 Nude Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1057_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1057 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 203 True Beige Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1058_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1058 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 300 Sand Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1059_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1059 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 301 Warm Honey Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1060_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1060 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 302 Golden Honey Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1061_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1061 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 303 True Nude Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1062_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1062 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 400 Natural Beige Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1063_b79efe82-a872-4bbf-8fee-f996beca96a3 76485-1063 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 20 - Shade 402 Bronze Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; 2.374 g/30mL; g/30mL N 20181231 76485-1064_a2f4350d-1763-4d86-85f3-652b82029f91 76485-1064 HUMAN OTC DRUG MATCH PERFECTION Foundation SPF 18 Shade 502 Noisette Octinoxate and Titanium Dioxide LIQUID TOPICAL 20160101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE; TITANIUM DIOXIDE 1.278; .949 g/30mL; g/30mL N 20181231 76485-1070_0d3fa2cd-dada-4571-8e46-b7bf66e2b40a 76485-1070 HUMAN OTC DRUG Rimmel BB Cream 9-in-1 Skin Perfecting Super Makeup Light AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .9; 1.3; 1.3; .6 g/30mL; g/30mL; g/30mL; g/30mL E 20171231 76485-1071_0d3fa2cd-dada-4571-8e46-b7bf66e2b40a 76485-1071 HUMAN OTC DRUG Rimmel BB Cream 9-in-1 Skin Perfecting Super Makeup Medium AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE CREAM TOPICAL 20140501 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .9; 1.3; 1.3; .6 g/30mL; g/30mL; g/30mL; g/30mL E 20171231 76485-1072_294fbd4a-85d5-4e4f-beff-5ee4baea8816 76485-1072 HUMAN OTC DRUG Rimmel Insta Flawless Perfecting Radiant Skin Tint Light Medium AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE CREAM TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .9; .9; 1.2; .6 g/30mL; g/30mL; g/30mL; g/30mL N 20181231 76485-1073_294fbd4a-85d5-4e4f-beff-5ee4baea8816 76485-1073 HUMAN OTC DRUG Rimmel Insta Flawless Perfecting Radiant Skin Tint Medium Dark AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE CREAM TOPICAL 20140101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE .9; 1.3; 1.3; .6 g/30mL; g/30mL; g/30mL; g/30mL N 20181231 76485-1074_de7e0a4e-36ea-49f7-b26c-bde26ab1abac 76485-1074 HUMAN OTC DRUG Rimmel BB Cream Beauty Balm Very Light OCTINOXATE CREAM TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE 1.3 g/30mL N 20181231 76485-1075_de7e0a4e-36ea-49f7-b26c-bde26ab1abac 76485-1075 HUMAN OTC DRUG Rimmel BB Cream Beauty Balm Light OCTINOXATE CREAM TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE 1.3 g/30mL N 20181231 76485-1076_de7e0a4e-36ea-49f7-b26c-bde26ab1abac 76485-1076 HUMAN OTC DRUG Rimmel BB Cream Beauty Balm Light Medium OCTINOXATE CREAM TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE 1.3 g/30mL N 20181231 76485-1077_de7e0a4e-36ea-49f7-b26c-bde26ab1abac 76485-1077 HUMAN OTC DRUG Rimmel BB Cream Beauty Balm Medium OCTINOXATE CREAM TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE 1.3 g/30mL N 20181231 76485-1078_de7e0a4e-36ea-49f7-b26c-bde26ab1abac 76485-1078 HUMAN OTC DRUG Rimmel BB Cream Beauty Balm Dark OCTINOXATE CREAM TOPICAL 20170101 OTC MONOGRAPH NOT FINAL part352 Rimmel Inc. OCTINOXATE 1.3 g/30mL N 20181231 76489-001_3423e193-0e4c-4c64-9e56-cd6ff57ac316 76489-001 CELLULAR THERAPY HemaCord HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL INJECTION INTRAVENOUS 20111110 BLA BLA125397 New York Blood Center HUMAN CORD BLOOD HEMATOPOIETIC PROGENITOR CELL 500000000 1/25mL Allogeneic Cord Blood Hematopoietic Progenitor Cell Therapy [EPC],Hematopoietic Stem Cells [Chemical/Ingredient],Cells, Allogeneic [Chemical/Ingredient] N 20181231 76494-528_9e9e646c-9d55-4222-b3ea-50f46519cf9b 76494-528 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 Prinston Pharmaceutical Inc. LEVETIRACETAM 250 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76494-529_9e9e646c-9d55-4222-b3ea-50f46519cf9b 76494-529 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 Prinston Pharmaceutical Inc. LEVETIRACETAM 500 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76494-530_9e9e646c-9d55-4222-b3ea-50f46519cf9b 76494-530 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 Prinston Pharmaceutical Inc. LEVETIRACETAM 750 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76494-531_9e9e646c-9d55-4222-b3ea-50f46519cf9b 76494-531 HUMAN PRESCRIPTION DRUG Levetiracetam Levetiracetam TABLET, FILM COATED ORAL 20120911 ANDA ANDA078106 Prinston Pharmaceutical Inc. LEVETIRACETAM 1000 mg/1 Decreased Central Nervous System Disorganized Electrical Activity [PE] E 20171231 76499-002_2f1bcc70-8bbc-4b60-847b-4c6f22470bbf 76499-002 HUMAN OTC DRUG Shaving Factory Disposable Styptic Pencil ALUMINUM SULFATE STICK TOPICAL 20120101 OTC MONOGRAPH FINAL part347 Derby International LLC ALUMINUM SULFATE 9 mL/10mL E 20171231 76509-001_85541720-1282-4fd8-ba80-6e93fc7a2741 76509-001 HUMAN OTC DRUG MAXRELIEF ARNICA MONTANA FLOWER SPRAY TOPICAL 20120101 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd ARNICA MONTANA FLOWER; ROSEMARY OIL; EUCALYPTUS OIL 50; 110; 6 mg/120mL; mg/120mL; mg/120mL E 20171231 76509-050_895a085e-3ec5-47f2-a8ba-90081566a7a9 76509-050 HUMAN OTC DRUG Kids Travel Sickness Cocculus 30C, Nux Vomica 30C, Borax 6C LOZENGE ORAL 20140211 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA JATEORHIZA CALUMBA ROOT; STRYCHNOS NUX-VOMICA SEED; SODIUM BORATE 30; 30; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 76509-100_64217008-f13d-4ad5-8ec0-1b815a18876f 76509-100 HUMAN OTC DRUG kids throat Aconite 30C, Belladonna 30C, Chamomilla 30C, Phytolacca 30C LOZENGE ORAL 20140212 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA ACONITUM NAPELLUS; BELLADONNA LEAF; MATRICARIA RECUTITA; PHYTOLACCA AMERICANA ROOT 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 76509-150_289aaee7-1d88-4140-aa3a-90ce1ee74e28 76509-150 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140212 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA DROSERA INTERMEDIA; SPONGIA OFFICINALIS WHOLE; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA VULGARIS; ATROPA BELLADONNA; IPECAC 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 76509-151_24047d42-b37a-4a8f-bac3-02a39276a9c4 76509-151 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA DROSERA INTERMEDIA; SPONGIA OFFICINALIS WHOLE; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA VULGARIS; ATROPA BELLADONNA; IPECAC 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 76509-152_2c9aa74d-941f-4035-8b35-73e11f8f909d 76509-152 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA DROSERA INTERMEDIA; SPONGIA OFFICINALIS WHOLE; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA VULGARIS; ATROPA BELLADONNA; IPECAC 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 76509-180_4ff88769-7699-42c4-ac40-86fc9c6b441e 76509-180 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA DROSERA INTERMEDIA; SPONGIA OFFICINALIS WHOLE; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA VULGARIS; ATROPA BELLADONNA; IPECAC 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 76509-200_620ee495-da43-45d4-8b51-f06c588e1581 76509-200 HUMAN OTC DRUG kids cold Allium Cepa 30C, Kali Bichromium 30C, Kali Sulphuricum 30C, Nux Vomica 30C, Natrum Muriaticum 30C, Pulsatilla 30C, Silicea 30C LOZENGE ORAL 20140430 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA ONION; POTASSIUM DICHROMATE; POTASSIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; SODIUM CHLORIDE; PULSATILLA VULGARIS; SILICON DIOXIDE 30; 30; 30; 30; 30; 30; 30 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 E 20171231 76509-400_2947edb5-cf6e-4472-8d3c-84a73495e7da 76509-400 HUMAN OTC DRUG kids cough cold and throat Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipeacacuhuana 30C, Pulsatilla 30C, Belladonna 30C KIT 20140430 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA E 20171231 76509-700_2d97dcaa-cd15-496e-823e-eacfe5ffa059 76509-700 HUMAN OTC DRUG MaxRelief Arnica camphor CREAM TOPICAL 20140601 OTC MONOGRAPH NOT FINAL part348 Natures Investment Holdings Pty Ltd dba Maxrelief USA CAMPHOR (NATURAL) 30 mg/1000mg N 20181231 76509-800_676d83c7-ffe3-4d9d-8d57-182de5980c08 76509-800 HUMAN OTC DRUG kids cough Drosera 30C, Spongia 30C, Kali Carbonicum 30C, Phospherous 30C, Ipecacuhuana 30C, Pulsatilla 30C, Belladonna 30C KIT 20140430 UNAPPROVED HOMEOPATHIC Natures Investment Holdings Pty Ltd dba Maxrelief USA E 20171231 76518-100_28931b86-a3a1-42b5-a2df-45be00c37de3 76518-100 HUMAN OTC DRUG Sennazon Sennosides A and B SYRUP ORAL 20120501 OTC MONOGRAPH NOT FINAL part334 Bayshore Pharmaceuticals LLC [FL] SENNOSIDES A AND B 8.8 mg/5mL E 20171231 76519-1000_1987e93d-951f-4738-af92-6196f753d121 76519-1000 HUMAN PRESCRIPTION DRUG CYCLOBENZAPRINE HYROCHLORIDE CYCLOBENZAPRINE HYDROCHLORIDE TABLET ORAL 20110829 ANDA ANDA078722 H.J. Harkins Company, Inc. CYCLOBENZAPRINE HYDROCHLORIDE 7.5 mg/1 Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] E 20171231 76519-1001_989e7994-d299-4a68-ae22-259fd0290a3e 76519-1001 HUMAN PRESCRIPTION DRUG Levofloxacin Levofloxacin TABLET, FILM COATED ORAL 20111122 ANDA ANDA076361 H.J. Harkins Company, Inc. LEVOFLOXACIN 500 mg/1 Quinolone Antimicrobial [EPC],Quinolones [Chemical/Ingredient] E 20171231 76519-1003_c92ab250-669c-4b29-945f-c6320a6a4edc 76519-1003 HUMAN OTC DRUG DOK EXTRA STRENGTH STOOL SOFTENER DOCUSATE SODIUM CAPSULE, LIQUID FILLED ORAL 20020827 OTC MONOGRAPH NOT FINAL part334 H.J. Harkins Company, Inc. DOCUSATE SODIUM 250 mg/1 E 20171231 76519-1004_25eeeb36-7337-49e8-a1ef-731e8afcca43 76519-1004 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20070816 ANDA ANDA078425 H.J. Harkins Company, Inc. SIMVASTATIN 5 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] E 20171231 76519-1005_dae1ab04-6614-4083-b7b6-2612c4be0fe2 76519-1005 HUMAN PRESCRIPTION DRUG Lamivudine and Zidovudine Lamivudine and Zidovudine TABLET, FILM COATED ORAL 20111227 ANDA ANDA079081 H.J. Harkins Company, Inc. LAMIVUDINE; ZIDOVUDINE 150; 300 mg/1; mg/1 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] E 20171231 76519-1007_4c109ffc-d99f-4beb-bc0a-4e340b56396c 76519-1007 HUMAN PRESCRIPTION DRUG Nystatin Nystatin POWDER TOPICAL 20090915 ANDA ANDA065203 H.J. Harkins Company, Inc. NYSTATIN 100000 [USP'U]/g Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient] E 20171231 76519-1009_f16375f3-737f-41b8-a412-6962874bd080 76519-1009 HUMAN PRESCRIPTION DRUG Tramadol Hydrochloride Tramadol Hydrochloride CAPSULE, EXTENDED RELEASE ORAL 20120314 NDA NDA022370 H.J. Harkins Company, Inc. TRAMADOL HYDROCHLORIDE 150 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] E 20171231 76519-1011_f83eee6e-4593-47b2-b948-d06a31eab363 76519-1011 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartate and Acetaminophen HYDROCODONE BITARTRATE, ACETAMINOPHEN TABLET ORAL 20120517 ANDA ANDA040846 H.J. Harkins Company, Inc. HYDROCODONE BITARTRATE; ACETAMINOPHEN 2.5; 325 mg/1; mg/1 Opioid Agonist [EPC],Opioid Agonists [MoA] CIII E 20171231 76519-1016_5df77934-8584-0707-e053-2991aa0a52e5 76519-1016 HUMAN PRESCRIPTION DRUG Clopidogrel Clopidogrel TABLET ORAL 20171106 ANDA ANDA202928 H.J. Harkins Company Inc CLOPIDOGREL BISULFATE 75 mg/1 Decreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA] N 20181231 76519-1017_70ee2244-de89-4c89-8a23-b23d2843f281 76519-1017 HUMAN PRESCRIPTION DRUG Sprix ketorolac tromethamine SPRAY, METERED NASAL 20110426 NDA NDA022382 H.J. Harkins Company, Inc. KETOROLAC TROMETHAMINE 15.75 mg/1 Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC] E 20171231 76519-1018_5568ac37-6035-2828-e054-00144ff8d46c 76519-1018 HUMAN PRESCRIPTION DRUG Fluticasone Propionate Fluticasone Propionate CREAM TOPICAL 20170103 ANDA ANDA076793 H J Harkins Company, Inc. FLUTICASONE PROPIONATE .5 mg/1 Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 76519-1021_5f250748-b4b9-571c-e053-2991aa0ae218 76519-1021 HUMAN PRESCRIPTION DRUG BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20170103 ANDA ANDA206556 H.J. Harkins Company Inc. BUPROPION HYDROCHLORIDE 150 mg/1 Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA] N 20181231 76519-1048_5fd89b31-7c78-2741-e053-2a91aa0a6790 76519-1048 HUMAN PRESCRIPTION DRUG PREDNISONE PREDNISONE TABLET ORAL 20170103 ANDA ANDA040256 H. J. Harkins Company Inc. PREDNISONE 5 mg/1 N 20181231 76519-1063_5f4b905e-588f-d760-e053-2991aa0ae134 76519-1063 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170103 ANDA ANDA091624 H.J Harkins Company Inc. ATORVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 76519-1075_5e88776b-1d1e-09a9-e053-2991aa0a07e9 76519-1075 HUMAN PRESCRIPTION DRUG Atorvastatin Calcium Atorvastatin Calcium TABLET ORAL 20171120 ANDA ANDA091650 H.J. Harkins Company Inc. ATORVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 76519-1084_5f4d4e97-fc37-abac-e053-2a91aa0aaaf8 76519-1084 HUMAN PRESCRIPTION DRUG ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170103 ANDA ANDA205519 H. J. Harkins Company Inc. ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 76519-1130_5554d179-32de-531e-e054-00144ff8d46c 76519-1130 HUMAN PRESCRIPTION DRUG ISENTRESS RALTEGRAVIR TABLET, FILM COATED ORAL 20170731 NDA NDA022145 H.J. Harkins Company Inc. RALTEGRAVIR POTASSIUM 400 mg/1 HIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC] N 20181231 76519-1132_60a69afa-3499-3562-e053-2a91aa0a78d5 76519-1132 HUMAN PRESCRIPTION DRUG TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TABLET, COATED ORAL 20170103 ANDA ANDA201384 H. J. Harkins Company Inc. TRAMADOL HYDROCHLORIDE 200 mg/1 Full Opioid Agonists [MoA],Opioid Agonist [EPC] CIV N 20181231 76519-1135_5dfacc4f-116e-805b-e053-2991aa0a30a7 76519-1135 HUMAN PRESCRIPTION DRUG Sildenafil Sildenafil TABLET, FILM COATED ORAL 20171102 ANDA ANDA203814 H. J. Harkins Company Inc. SILDENAFIL CITRATE 20 mg/1 Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA] N 20181231 76519-1150_60f3672f-4ca4-17ea-e053-2991aa0a6b5e 76519-1150 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20170216 ANDA ANDA077783 H. J. Harkins Company Inc. LAMOTRIGINE 25 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 76519-1151_60f3672f-4ca4-17ea-e053-2991aa0a6b5e 76519-1151 HUMAN PRESCRIPTION DRUG LAMOTRIGINE LAMOTRIGINE TABLET ORAL 20170216 ANDA ANDA077783 H. J. Harkins Company Inc. LAMOTRIGINE 100 mg/1 Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] N 20191231 76519-1152_60b87f7a-35c3-ab20-e053-2991aa0a793b 76519-1152 HUMAN PRESCRIPTION DRUG METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE ORAL 20170324 ANDA ANDA077336 H. J. Harkins Company Inc. METFORMIN HYDROCHLORIDE 500 mg/1 Biguanide [EPC],Biguanides [Chemical/Ingredient] N 20181231 76519-1153_60a5f95f-57e6-85ec-e053-2991aa0a8f11 76519-1153 HUMAN PRESCRIPTION DRUG ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170515 ANDA ANDA206434 H. J. Harkins Company Inc. ROSUVASTATIN CALCIUM 40 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 76519-1154_60a394a5-04c7-819e-e053-2a91aa0add1f 76519-1154 HUMAN PRESCRIPTION DRUG BENZPHETAMINE HYDROCHLORIDE BENZPHETAMINE HYDROCHLORIDE TABLET ORAL 20170607 ANDA ANDA090968 H. J. Harkins Company Inc. BENZPHETAMINE HYDROCHLORIDE 50 mg/1 Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC] CIII N 20181231 76519-1158_5fda7b01-feb1-13b1-e053-2a91aa0abe28 76519-1158 HUMAN PRESCRIPTION DRUG VALSARTAN VALSARTAN TABLET ORAL 20170803 ANDA ANDA204821 H. J. Harkins Company Inc. VALSARTAN 160 mg/1 Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC] N 20181231 76519-1159_5fd9467f-9139-f7c9-e053-2a91aa0a5ef0 76519-1159 HUMAN PRESCRIPTION DRUG DICLOFENAC SODIUM DICLOFENAC GEL TOPICAL 20170911 ANDA ANDA208077 H. J. Harkins Company Inc. DICLOFENAC SODIUM 10 mg/1 Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] N 20181231 76519-1160_5f256d4f-450a-87c7-e053-2a91aa0a79ef 76519-1160 HUMAN PRESCRIPTION DRUG NALTREXONE HYDROCHLORIDE NALTREXONE HYDROCHLORIDE TABLET, FILM COATED ORAL 20171017 ANDA ANDA075274 H.J. Harkins Company Inc. NALTREXONE HYDROCHLORIDE 50 mg/1 Opioid Antagonist [EPC],Opioid Antagonists [MoA] N 20181231 76519-1162_5f248416-c8f9-98b2-e053-2991aa0aa855 76519-1162 HUMAN PRESCRIPTION DRUG ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET, FILM COATED ORAL 20170103 ANDA ANDA079171 H. J. Harkins Company Inc. ROSUVASTATIN CALCIUM 10 mg/1 HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] N 20181231 79596-090_91a8f2e4-648e-4fd7-8ca9-7f77183882ea 79596-090 HUMAN OTC DRUG Too Faced Tinted Beauty Balm SPF-20 TITANIUM DIOXIDE ZINC OXIDE CREAM TOPICAL 20121214 OTC MONOGRAPH FINAL part352 TOO FACED COSMETICS TITANIUM DIOXIDE; ZINC OXIDE 5; 5 g/100mL; g/100mL N 20181231 79596-096_5061cfdc-3dc4-4c21-a23a-3c1e6a2afd0e 79596-096 HUMAN OTC DRUG Too Faced BB Creme Complete Coverage Make-Up SPF-20 SNOW GLOW TITANIUM DIOXIDE CREAM TOPICAL 20121214 OTC MONOGRAPH FINAL part352 TOO FACED COSMETICS TITANIUM DIOXIDE 8.3 g/100g E 20171231 79596-097_db32e599-9e5d-4467-8aba-62ea222e12c3 79596-097 HUMAN OTC DRUG Too Faced BB Creme Complete Coverage Make-Up SPF-20 VANILLA GLOW TITANIUM DIOXIDE CREAM TOPICAL 20121214 OTC MONOGRAPH FINAL part352 TOO FACED COSMETICS TITANIUM DIOXIDE 8.3 g/100g E 20171231 79596-098_365d74d4-7172-4478-98b9-8e2553222ca1 79596-098 HUMAN OTC DRUG Too Faced BB Creme Complete Coverage Make-Up SPF-20 CREAM GLOW TITANIUM DIOXIDE CREAM TOPICAL 20121214 OTC MONOGRAPH FINAL part352 TOO FACED COSMETICS TITANIUM DIOXIDE 8.3 g/100g E 20171231 79596-099_dc0a1453-3c55-494b-a1bf-63bf913cfc65 79596-099 HUMAN OTC DRUG Too Faced BB Creme Complete Coverage Make-Up SPF-20 LINEN GLOW TITANIUM DIOXIDE CREAM TOPICAL 20121214 OTC MONOGRAPH FINAL part352 TOO FACED COSMETICS TITANIUM DIOXIDE 8.3 g/100g E 20171231 79596-100_2bc77006-026f-49f3-a738-6461eaf35841 79596-100 HUMAN OTC DRUG Too Faced BB Creme Complete Coverage Make-Up SPF-20 NUDE GLOW TITANIUM DIOXIDE CREAM TOPICAL 20121214 OTC MONOGRAPH FINAL part352 TOO FACED COSMETICS TITANIUM DIOXIDE 8.3 g/100g E 20171231 79971-001_60f12f69-6a72-50bd-e053-2a91aa0afcd7 79971-001 HUMAN PRESCRIPTION DRUG Oxygen Oxygen GAS RESPIRATORY (INHALATION) 20121115 NDA NDA206023 Tech Air of Texas, Inc. OXYGEN 99.1 L/L N 20181231 79971-002_60f17b9f-5592-ae95-e053-2a91aa0a7060 79971-002 HUMAN PRESCRIPTION DRUG Nitrogen Nitrogen GAS RESPIRATORY (INHALATION) 20121115 NDA NDA206024 Tech Air of Texas, Inc. NITROGEN 99.1 L/L N 20181231 81984-099_60c0bc37-83b2-3280-e053-2a91aa0ae7c9 81984-099 HUMAN OTC DRUG 4OZ MEDICATED CHEST RUB menthol, camphor, eucalyptus oil OINTMENT TOPICAL 20171201 OTC MONOGRAPH NOT FINAL part348 Pride Products Corporation MENTHOL; EUCALYPTUS OIL; CAMPHOR (SYNTHETIC) 1; 1; 4.7 g/100g; g/100g; g/100g N 20181231 8290-3268_8b3a9227-7931-45b4-b256-1358469c0595 8290-3268 HUMAN OTC DRUG Isopropyl Alcohol Isopropyl Alcohol SWAB TOPICAL 19931001 OTC MONOGRAPH NOT FINAL part333A Becton Dickinson and Company ISOPROPYL ALCOHOL .75 g/1 N 20181231 86227-000_61592eb7-081f-64e9-e053-2991aa0a670e 86227-000 HUMAN OTC DRUG SURE COMFORT ALCOHOL PREP PADS ISOPROPYL ALCOHOL SWAB TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333A Allison Medical Inc. ISOPROPYL ALCOHOL 70 mL/100mL N 20191231 87010-002_a67515c5-7dff-4cc5-86b2-09e2e65c313f 87010-002 HUMAN OTC DRUG Isopropyl Rubbing Alcohol Isopropyl Alcohol SOLUTION TOPICAL 20171108 OTC MONOGRAPH NOT FINAL part333A Healthstar LLC ISOPROPYL ALCOHOL 70 mL/100mL N 20181231 8880-9505_1394ceab-ed35-41fe-8ceb-bd2a83912d0f 8880-9505 HUMAN PRESCRIPTION DRUG Thermazene Silver Sulfadiazine CREAM TOPICAL 20120820 NDA NDA018810 COVIDIEN INC. SILVER SULFADIAZINE 10 mg/g Sulfonamide Antibacterial [EPC],Sulfonamides [Chemical/Ingredient] E 20171231 89141-123_692e18cb-037d-4d92-9f59-1e5de1b53ab4 89141-123 HUMAN PRESCRIPTION DRUG Soltamox TAMOXIFEN CITRATE LIQUID ORAL 20051029 NDA NDA021807 Midatech Pharma US Inc. TAMOXIFEN CITRATE 20 mg/10mL Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA] N 20181231 89141-250_129cc319-9c75-45c8-b39c-d86fa44398ef 89141-250 HUMAN PRESCRIPTION DRUG ORAVIG miconazole TABLET BUCCAL 20100416 NDA NDA022404 Midatech Pharma US, Inc. MICONAZOLE 50 mg/1 Azole Antifungal [EPC],Azoles [Chemical/Ingredient] N 20181231 89141-444_205600d1-67dc-4000-b319-6abd6a86019f 89141-444 HUMAN PRESCRIPTION DRUG ZUPLENZ ondansetron FILM ORAL 20100702 NDA NDA022524 Midatech Pharma US, Inc. ONDANSETRON 4 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 89141-448_205600d1-67dc-4000-b319-6abd6a86019f 89141-448 HUMAN PRESCRIPTION DRUG ZUPLENZ ondansetron FILM ORAL 20100702 NDA NDA022524 Midatech Pharma US, Inc. ONDANSETRON 8 mg/1 Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC] N 20181231 89153-796_161454eb-4b04-45c0-a304-1bc3e9a8c4ae 89153-796 HUMAN OTC DRUG Dr. Rothmans Dermashield Instant and Long Lasting Sanitizer and Moisturizer SPRAY TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part333A High Desert Pharmaceutics, Inc. ALCOHOL; BENZALKONIUM CHLORIDE 37.2; .06 g/60g; g/60g E 20171231 89156-000_39c21557-410e-4fa4-e054-00144ff8d46c 89156-000 HUMAN OTC DRUG Global EASY PREP alcohol prep pads ISOPROPYL ALCOHOL LIQUID TOPICAL 20160803 OTC MONOGRAPH NOT FINAL part333A Global Diabetic Distributors ISOPROPYL ALCOHOL 70 g/100g N 20181231 89474-100_074ad390-ab24-0e7a-e054-00144ff88e88 89474-100 HUMAN OTC DRUG CareFine Alcohol Swabs 100 ct Isopropyl Alcohol Swab SWAB TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A Facet Technologies ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 89474-102_074c7751-c3a7-3ab6-e054-00144ff8d46c 89474-102 HUMAN OTC DRUG CareFine Alcohol Swabs 200 Ct Isopropyl Alcohol Swab SWAB TOPICAL 20141001 OTC MONOGRAPH NOT FINAL part333A Facet Technologies ISOPROPYL ALCOHOL 70 mL/100mL E 20171231 98132-121_f6ca65be-cdef-4f41-a842-0925ad450bb7 98132-121 HUMAN OTC DRUG Deep Bisque Original Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 16; 10 g/100g; g/100g N 20181231 98132-122_46ef8e6f-96f3-441e-a4ef-dc3a6d5f863e 98132-122 HUMAN OTC DRUG bareMinerals Natural Sunscreen Light Titanium Dioxide POWDER TOPICAL 20090131 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 12 g/100g N 20181231 98132-123_d9c5bb8f-e1e7-4b4a-89db-78c1f34454b5 98132-123 HUMAN OTC DRUG BareMinerals Natural Sunscreen Medium Titanium Dioxide POWDER TOPICAL 20090131 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 12 g/100g N 20181231 98132-124_8a86b900-d14d-4842-842d-2a631f14c38a 98132-124 HUMAN OTC DRUG Natural Sunscreen Tan Titanium Dioxide POWDER TOPICAL 20090131 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 12 g/100g E 20171231 98132-128_2421e199-7229-46a7-b3b5-4a669006dba0 98132-128 HUMAN OTC DRUG BareMinerals Fair Matte Fair Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-129_2421e199-7229-46a7-b3b5-4a669006dba0 98132-129 HUMAN OTC DRUG BareMinerals Light Matte Light Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-130_2421e199-7229-46a7-b3b5-4a669006dba0 98132-130 HUMAN OTC DRUG BareMinerals Fairly Light matte Fairly Light Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-131_2421e199-7229-46a7-b3b5-4a669006dba0 98132-131 HUMAN OTC DRUG BareMinerals Medium Beige matte Medium Beige Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-132_2421e199-7229-46a7-b3b5-4a669006dba0 98132-132 HUMAN OTC DRUG BareMinerals Medium Matte Medium Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-133_2421e199-7229-46a7-b3b5-4a669006dba0 98132-133 HUMAN OTC DRUG BareMinerals Medium Tan matte Medium Tan Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-134_2421e199-7229-46a7-b3b5-4a669006dba0 98132-134 HUMAN OTC DRUG BareMinerals Golden Medium matte Golden Medium Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-135_2421e199-7229-46a7-b3b5-4a669006dba0 98132-135 HUMAN OTC DRUG BareMinerals Warm Tan Warm Tan Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-136_2421e199-7229-46a7-b3b5-4a669006dba0 98132-136 HUMAN OTC DRUG BareMinerals Tan Matte Tan Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-137_2421e199-7229-46a7-b3b5-4a669006dba0 98132-137 HUMAN OTC DRUG BareMinerals Dark Matte Dark Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-138_2421e199-7229-46a7-b3b5-4a669006dba0 98132-138 HUMAN OTC DRUG BareMinerals Golden Deep matte Golden Deep Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-139_2421e199-7229-46a7-b3b5-4a669006dba0 98132-139 HUMAN OTC DRUG BareMinerals Medium Deep matte Medium Deep Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-140_2421e199-7229-46a7-b3b5-4a669006dba0 98132-140 HUMAN OTC DRUG BareMinerals Deepest Deep matte Deepest Deep Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-141_2421e199-7229-46a7-b3b5-4a669006dba0 98132-141 HUMAN OTC DRUG BareMinerals Golden Dark matte Golden Dark Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-142_2421e199-7229-46a7-b3b5-4a669006dba0 98132-142 HUMAN OTC DRUG BareMinerals Medium Dark matte Medium Dark Matte Titanium Dioxide and Zinc Oxide POULTICE TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-147_cdafa965-da3d-4ab2-a1c0-6e95ee138512 98132-147 HUMAN OTC DRUG Golden Tan Original Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11.7; 20 g/100g; g/100g N 20181231 98132-148_84629839-2271-430a-a37f-e7b6e06f5c44 98132-148 HUMAN OTC DRUG Warm Dark Original Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 20 g/100g; g/100g N 20181231 98132-149_22c8402f-b073-47c9-87a6-c7e978f78539 98132-149 HUMAN OTC DRUG Warm Deep Original Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 7; 20 g/100g; g/100g N 20181231 98132-151_70917078-7a5b-4f3c-862c-ebf0dd893153 98132-151 HUMAN OTC DRUG bareMinerals Matte Foundation Broad Spectrum SPF 15 Golden Fair Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-152_70917078-7a5b-4f3c-862c-ebf0dd893153 98132-152 HUMAN OTC DRUG bareMinerals Matte Foundation Broad Spectrum SPF 15 Fairly Medium Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-153_2421e199-7229-46a7-b3b5-4a669006dba0 98132-153 HUMAN OTC DRUG BareMinerals Golden Tan matte Golden Tan Matte Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090731 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-154_70917078-7a5b-4f3c-862c-ebf0dd893153 98132-154 HUMAN OTC DRUG bareMinerals Matte Foundation Broad Spectrum SPF 15 Warm Dark Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20100630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-156_cb4110fa-94bc-4907-b3f0-1de6275bb8e5 98132-156 HUMAN OTC DRUG bareMinerals Matte Foundation Broad Spectrum SPF 15 Warm Deep Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-158_4dea5c89-c41a-47ed-a8bd-76a8ca83983a 98132-158 HUMAN OTC DRUG BareMinerals Faux Tan Faux Tan Titanium Dioxide POWDER TOPICAL 20110105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 25 g/100g E 20171231 98132-159_d06886ac-6218-48c3-a2b5-b08f055dc444 98132-159 HUMAN OTC DRUG BareMinerals Mineral Veil Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090730 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 10 g/100g; g/100g N 20181231 98132-160_d06886ac-6218-48c3-a2b5-b08f055dc444 98132-160 HUMAN OTC DRUG BareMinerals Tinted Mineral Veil Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20090730 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 10 g/100g; g/100g N 20181231 98132-161_e393dbba-bc6a-463f-bb3e-3afc30d6b2c5 98132-161 HUMAN OTC DRUG BareMinerals Bronzing Mineral Veil Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20110105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 10 g/100g; g/100g E 20171231 98132-162_7b4cf4ec-8db5-4db6-91a2-4dea25f70457 98132-162 HUMAN OTC DRUG bareMinerals Well-rested Titanium Dioxide POWDER TOPICAL 20110105 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 20 g/100g N 20181231 98132-163_11552850-abf2-40ca-9530-627246a3b27e 98132-163 HUMAN OTC DRUG Ready Foundation Fair Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-164_11552850-abf2-40ca-9530-627246a3b27e 98132-164 HUMAN OTC DRUG Ready Foundation Fairly Light Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-165_11552850-abf2-40ca-9530-627246a3b27e 98132-165 HUMAN OTC DRUG Ready Foundation Golden Fair Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-166_11552850-abf2-40ca-9530-627246a3b27e 98132-166 HUMAN OTC DRUG Ready Foundation Light Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-167_11552850-abf2-40ca-9530-627246a3b27e 98132-167 HUMAN OTC DRUG Ready Foundation Fairly Medium Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-168_11552850-abf2-40ca-9530-627246a3b27e 98132-168 HUMAN OTC DRUG Ready Foundation Medium Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-169_11552850-abf2-40ca-9530-627246a3b27e 98132-169 HUMAN OTC DRUG Ready Foundation Medium Beige Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-170_11552850-abf2-40ca-9530-627246a3b27e 98132-170 HUMAN OTC DRUG Ready Foundation Golden Medium Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-171_11552850-abf2-40ca-9530-627246a3b27e 98132-171 HUMAN OTC DRUG Ready Foundation Medium Tan Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-172_11552850-abf2-40ca-9530-627246a3b27e 98132-172 HUMAN OTC DRUG Ready Foundation Tan Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-173_11552850-abf2-40ca-9530-627246a3b27e 98132-173 HUMAN OTC DRUG Ready Foundation Warm Tan Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-174_11552850-abf2-40ca-9530-627246a3b27e 98132-174 HUMAN OTC DRUG Ready Foundation Golden Tan Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-175_11552850-abf2-40ca-9530-627246a3b27e 98132-175 HUMAN OTC DRUG Ready Foundation Dark Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-176_11552850-abf2-40ca-9530-627246a3b27e 98132-176 HUMAN OTC DRUG Ready Foundation Medium Dark Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-177_11552850-abf2-40ca-9530-627246a3b27e 98132-177 HUMAN OTC DRUG Ready Foundation Warm Dark Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-178_11552850-abf2-40ca-9530-627246a3b27e 98132-178 HUMAN OTC DRUG Ready Foundation Golden Dark Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-179_11552850-abf2-40ca-9530-627246a3b27e 98132-179 HUMAN OTC DRUG Ready Foundation Medium Deep Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-180_11552850-abf2-40ca-9530-627246a3b27e 98132-180 HUMAN OTC DRUG Ready Foundation Deepest Deep Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-181_11552850-abf2-40ca-9530-627246a3b27e 98132-181 HUMAN OTC DRUG Ready Foundation Golden Deep Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-182_11552850-abf2-40ca-9530-627246a3b27e 98132-182 HUMAN OTC DRUG Ready Foundation Warm Deep Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20120601 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 11; 18 g/100g; g/100g E 20171231 98132-184_13e5d3d9-928d-4e92-a382-7e084f48f85c 98132-184 HUMAN OTC DRUG Antioxidant Primer Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20130331 OTC MONOGRAPH FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 26; 62 mg/mL; mg/mL E 20171231 98132-186_7797d4f9-33ac-4327-bd21-479ecf67ea43 98132-186 HUMAN OTC DRUG Pure Transformation Sheer Fair Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 18; 5 g/100g; g/100g N 20181231 98132-187_5a51c4b8-6823-4813-9a24-05e9c2289cf5 98132-187 HUMAN OTC DRUG Pure Transformation Sheer Light Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-188_5a51c4b8-6823-4813-9a24-05e9c2289cf5 98132-188 HUMAN OTC DRUG Pure Transformation Sheer Medium Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-189_7797d4f9-33ac-4327-bd21-479ecf67ea43 98132-189 HUMAN OTC DRUG Pure Transformation Sheer Tan Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 18; 5 g/100g; g/100g N 20181231 98132-190_d9974e93-5303-4639-b933-5c438d49dc2f 98132-190 HUMAN OTC DRUG Pure Transformation Sheer Clear Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 19; 5 g/100g; g/100g N 20181231 98132-191_5a51c4b8-6823-4813-9a24-05e9c2289cf5 98132-191 HUMAN OTC DRUG Pure Transformation Sheer Dark Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20130630 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 15; 5 g/100g; g/100g N 20181231 98132-201_262762e5-c64d-4356-be9c-30f756c5323d 98132-201 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Fair 01 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-202_262762e5-c64d-4356-be9c-30f756c5323d 98132-202 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Dawn 02 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-203_262762e5-c64d-4356-be9c-30f756c5323d 98132-203 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Champagne 03 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-204_262762e5-c64d-4356-be9c-30f756c5323d 98132-204 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Aspen 04 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-205_262762e5-c64d-4356-be9c-30f756c5323d 98132-205 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Sateen 05 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-206_262762e5-c64d-4356-be9c-30f756c5323d 98132-206 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Cashmere 06 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-207_262762e5-c64d-4356-be9c-30f756c5323d 98132-207 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Warm Light 07 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-208_262762e5-c64d-4356-be9c-30f756c5323d 98132-208 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Golden Ivory 08 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-209_262762e5-c64d-4356-be9c-30f756c5323d 98132-209 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Light Natural 09 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-210_262762e5-c64d-4356-be9c-30f756c5323d 98132-210 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Cool Beige 10 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-211_262762e5-c64d-4356-be9c-30f756c5323d 98132-211 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Natural 11 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-212_262762e5-c64d-4356-be9c-30f756c5323d 98132-212 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Warm Natural 12 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-213_262762e5-c64d-4356-be9c-30f756c5323d 98132-213 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Golden Nude 13 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-2131_6e877759-8ddb-49d8-be13-25eb21229299 98132-2131 HUMAN OTC DRUG bareMinerals Ready SPF 15 Touch Up Veil Titanium Dioxide POWDER TOPICAL 20110820 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 1.2 g/10g N 20181231 98132-2132_6e877759-8ddb-49d8-be13-25eb21229299 98132-2132 HUMAN OTC DRUG bareMinerals Ready SPF 15 Touch Up Veil Titanium Dioxide POWDER TOPICAL 20110820 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 1.2 g/10g N 20181231 98132-214_262762e5-c64d-4356-be9c-30f756c5323d 98132-214 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Silk 14 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-215_262762e5-c64d-4356-be9c-30f756c5323d 98132-215 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Sandalwood 15 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-216_262762e5-c64d-4356-be9c-30f756c5323d 98132-216 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Sandstone 16 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-217_262762e5-c64d-4356-be9c-30f756c5323d 98132-217 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Camel 17 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-218_262762e5-c64d-4356-be9c-30f756c5323d 98132-218 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Pecan 18 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-219_262762e5-c64d-4356-be9c-30f756c5323d 98132-219 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Toffee 19 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-220_262762e5-c64d-4356-be9c-30f756c5323d 98132-220 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Honeycomb 20 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-221_262762e5-c64d-4356-be9c-30f756c5323d 98132-221 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Sable 21 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-222_262762e5-c64d-4356-be9c-30f756c5323d 98132-222 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Teak 22 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-223_262762e5-c64d-4356-be9c-30f756c5323d 98132-223 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Cardamom 23 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-224_262762e5-c64d-4356-be9c-30f756c5323d 98132-224 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Nutmeg 24 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-225_262762e5-c64d-4356-be9c-30f756c5323d 98132-225 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Hazelnut 25 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-226_262762e5-c64d-4356-be9c-30f756c5323d 98132-226 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Chai 26 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-227_262762e5-c64d-4356-be9c-30f756c5323d 98132-227 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Cappuccino 27 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-228_262762e5-c64d-4356-be9c-30f756c5323d 98132-228 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Clove 28 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-229_262762e5-c64d-4356-be9c-30f756c5323d 98132-229 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Truffle 29 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-230_262762e5-c64d-4356-be9c-30f756c5323d 98132-230 HUMAN OTC DRUG bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Cocoa 30 Titanium Dioxide LIQUID TOPICAL 20170801 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 33.2 mg/mL N 20181231 98132-300_e4641aaf-fdfd-4ba7-888c-1ef8edaee397 98132-300 HUMAN OTC DRUG bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Translucent Titanium Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 1470; 100 mg/10g; mg/10g N 20181231 98132-301_e4641aaf-fdfd-4ba7-888c-1ef8edaee397 98132-301 HUMAN OTC DRUG bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Tan Titanium Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 1470; 100 mg/10g; mg/10g N 20181231 98132-302_e4641aaf-fdfd-4ba7-888c-1ef8edaee397 98132-302 HUMAN OTC DRUG bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Light Titanium Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 1470; 100 mg/10g; mg/10g N 20181231 98132-303_e4641aaf-fdfd-4ba7-888c-1ef8edaee397 98132-303 HUMAN OTC DRUG bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Medium Titanium Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 1470; 100 mg/10g; mg/10g N 20181231 98132-304_e4641aaf-fdfd-4ba7-888c-1ef8edaee397 98132-304 HUMAN OTC DRUG bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Dark Titanium Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 1470; 100 mg/10g; mg/10g N 20181231 98132-305_e4641aaf-fdfd-4ba7-888c-1ef8edaee397 98132-305 HUMAN OTC DRUG bareMinerals READY Touch Up Veil Broad Spectrum SPF 15 Deep Titanium Dioxide and Zinc oxide POWDER TOPICAL 20130601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 1470; 100 mg/10g; mg/10g N 20181231 98132-664_782d8e17-e356-4504-b328-ef58861e42cf 98132-664 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g N 20181231 98132-665_782d8e17-e356-4504-b328-ef58861e42cf 98132-665 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g N 20181231 98132-666_782d8e17-e356-4504-b328-ef58861e42cf 98132-666 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g N 20181231 98132-667_782d8e17-e356-4504-b328-ef58861e42cf 98132-667 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g N 20181231 98132-668_782d8e17-e356-4504-b328-ef58861e42cf 98132-668 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g N 20181231 98132-669_782d8e17-e356-4504-b328-ef58861e42cf 98132-669 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g N 20181231 98132-670_782d8e17-e356-4504-b328-ef58861e42cf 98132-670 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g N 20181231 98132-671_782d8e17-e356-4504-b328-ef58861e42cf 98132-671 HUMAN OTC DRUG BareMinerals SPF 20 Correcting Concealer Titanium Dioxide CREAM TOPICAL 20120426 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE .3 g/2g N 20181231 98132-700_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-700 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Candlelit Peach Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL N 20181231 98132-701_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-701 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Radiant Sand Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL N 20181231 98132-702_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-702 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Soft Shell Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL N 20181231 98132-703_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-703 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Elegant Taupe Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL N 20181231 98132-704_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-704 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Soft Linen Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL N 20181231 98132-705_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-705 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Sweet Spice Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL N 20181231 98132-706_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-706 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Delicate Moss Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL N 20181231 98132-707_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-707 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Barely Nude Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL N 20181231 98132-708_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-708 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Blushing Pink Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL N 20181231 98132-709_6e756d5d-3d51-463b-9c29-dac6c238ac5e 98132-709 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Eyeshadow Broad Spectrum SPF 15 Divine Wine Titanium Dioxide CREAM TOPICAL 20140301 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 170 mg/mL N 20181231 98132-710_006572f0-a98e-485c-86c8-9762ab91a22d 98132-710 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Fair Game Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL N 20181231 98132-711_006572f0-a98e-485c-86c8-9762ab91a22d 98132-711 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Dim The Light Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL N 20181231 98132-712_006572f0-a98e-485c-86c8-9762ab91a22d 98132-712 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 In The Buff Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL N 20181231 98132-713_006572f0-a98e-485c-86c8-9762ab91a22d 98132-713 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Youre A Natural Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL N 20181231 98132-714_006572f0-a98e-485c-86c8-9762ab91a22d 98132-714 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Meet Me Latte Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL N 20181231 98132-715_006572f0-a98e-485c-86c8-9762ab91a22d 98132-715 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Sweet As Honey Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL N 20181231 98132-716_006572f0-a98e-485c-86c8-9762ab91a22d 98132-716 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Tan-Talize Me Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL N 20181231 98132-717_006572f0-a98e-485c-86c8-9762ab91a22d 98132-717 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Almond The Nude Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL N 20181231 98132-718_006572f0-a98e-485c-86c8-9762ab91a22d 98132-718 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Caramel Kisses Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL N 20181231 98132-719_006572f0-a98e-485c-86c8-9762ab91a22d 98132-719 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 In The Dark Octinoxate and Titanium Dioxide LIQUID TOPICAL 20140130 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL N 20181231 98132-720_3c85e1ac-7b22-445c-bd55-ef7d5448f30d 98132-720 HUMAN OTC DRUG bareMinerals Advanced Protection SPF 20 Moisturizer Combination Skin Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 50; 30 mg/mL; mg/mL N 20181231 98132-721_7f668ca5-1357-4899-b8b5-d39825aa1db8 98132-721 HUMAN OTC DRUG bareMinerals Advanced Protection SPF 20 Moisturizer Sheer Tint Combination Skin Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 50; 30 mg/mL; mg/mL N 20181231 98132-722_605838e6-ee08-42c8-be1a-a3aa20b9b50c 98132-722 HUMAN OTC DRUG bareMinerals Advanced Protection SPF 20 Moisturizer Normal to Dry Skin Titanium Dioxide LOTION TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 60 mg/mL N 20181231 98132-723_63d8d0cd-6fa7-4ed5-a014-a4b09ba348a9 98132-723 HUMAN OTC DRUG bareMinerals Advanced Protection SPF 20 Moisturizer Sheer Tint Normal to Dry Skin Titanium Dioxide LOTION TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 60 mg/mL N 20181231 98132-724_9de5fcaf-8ee5-4b95-9c4e-3dd5a5774b02 98132-724 HUMAN OTC DRUG bareMinerals Daily Defense Broad Spectrum SPF 30 Titanium Dioxide and Zinc Oxide LOTION TOPICAL 20131231 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 30; 1530 mg/mL; mg/mL N 20181231 98132-725_a3f1626d-a481-4615-bd93-23d9e71dbf4a 98132-725 HUMAN OTC DRUG bareMinerals Blemish Therapy Sulfur POWDER TOPICAL 20131231 OTC MONOGRAPH FINAL part333D Bare Escentuals Beauty, Inc. SULFUR 30 mg/g E 20171231 98132-726_e5f6f077-bbe4-4ec2-a089-c7b2b32c680f 98132-726 HUMAN OTC DRUG bareMinerals Prime Time BB Primer Daily Defense Broad Spectrum SPF 30 Fair Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 26; 62 mg/mL; mg/mL N 20181231 98132-727_e5f6f077-bbe4-4ec2-a089-c7b2b32c680f 98132-727 HUMAN OTC DRUG bareMinerals Prime Time BB Primer Daily Defense Broad Spectrum SPF 30 Light Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 26; 62 mg/mL; mg/mL N 20181231 98132-728_e5f6f077-bbe4-4ec2-a089-c7b2b32c680f 98132-728 HUMAN OTC DRUG bareMinerals Prime Time BB Primer Daily Defense Broad Spectrum SPF 30 Medium Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 26; 62 mg/mL; mg/mL N 20181231 98132-729_e5f6f077-bbe4-4ec2-a089-c7b2b32c680f 98132-729 HUMAN OTC DRUG bareMinerals Prime Time BB Primer Daily Defense Broad Spectrum SPF 30 Tan Titanium Dioxide and Zinc Oxide CREAM TOPICAL 20140201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE 26; 62 mg/mL; mg/mL E 20171231 98132-730_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-730 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Porcelain Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-731_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-731 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Shell Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-732_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-732 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Linen Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-733_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-733 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Ivory Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-734_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-734 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Cream Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-735_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-735 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Satin Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-736_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-736 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Natural Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-737_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-737 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Beige Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-738_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-738 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Nude Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-739_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-739 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Buff Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-740_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-740 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Latte Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-741_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-741 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Sand Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-742_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-742 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Tan Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-743_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-743 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Caramel Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-744_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-744 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Honey Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-745_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-745 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Almond Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-746_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-746 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Maple Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-747_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-747 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Walnut Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-748_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-748 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Espresso Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-749_4b091aa5-a5aa-4081-8709-f3382f1382b6 98132-749 HUMAN OTC DRUG bareMinerals bareSkin Pure Brightening Serum Foundation Broad Spectrum SPF 20 Bare Mocha Titanium Dioxide LIQUID TOPICAL 20140221 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 110 mg/mL N 20181231 98132-750_80d8d989-51d6-4912-bfd0-ca99b69be7c3 98132-750 HUMAN OTC DRUG bareMinerals 5-in-1 BB Advanced Performance Mineral Veil Finishing Broad Spectrum SPF 20 Titanium Dioxide and Zinc Oxide POWDER TOPICAL 20140315 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE; ZINC OXIDE .2; .2 g/g; g/g N 20181231 98132-751_1e44dea4-0e5b-497c-beca-586d1ccb8426 98132-751 HUMAN OTC DRUG bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01 Titanium Dioxide LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 62 mg/mL N 20181231 98132-752_1e44dea4-0e5b-497c-beca-586d1ccb8426 98132-752 HUMAN OTC DRUG bareMinerals Complexion Rescue Broad Spectrum SPF 30 Vanilla 02 Titanium Dioxide LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 62 mg/mL N 20181231 98132-753_1e44dea4-0e5b-497c-beca-586d1ccb8426 98132-753 HUMAN OTC DRUG bareMinerals Complexion Rescue Broad Spectrum SPF 30 Buttercream 03 Titanium Dioxide LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 62 mg/mL N 20181231 98132-754_1e44dea4-0e5b-497c-beca-586d1ccb8426 98132-754 HUMAN OTC DRUG bareMinerals Complexion Rescue Broad Spectrum SPF 30 Suede 04 Titanium Dioxide LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 62 mg/mL N 20181231 98132-755_1e44dea4-0e5b-497c-beca-586d1ccb8426 98132-755 HUMAN OTC DRUG bareMinerals Complexion Rescue Broad Spectrum SPF 30 Natural 05 Titanium Dioxide LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 62 mg/mL N 20181231 98132-756_1e44dea4-0e5b-497c-beca-586d1ccb8426 98132-756 HUMAN OTC DRUG bareMinerals Complexion Rescue Broad Spectrum SPF 30 Ginger 06 Titanium Dioxide LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 62 mg/mL N 20181231 98132-757_1e44dea4-0e5b-497c-beca-586d1ccb8426 98132-757 HUMAN OTC DRUG bareMinerals Complexion Rescue Broad Spectrum SPF 30 Tan 07 Titanium Dioxide LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 62 mg/mL N 20181231 98132-758_1e44dea4-0e5b-497c-beca-586d1ccb8426 98132-758 HUMAN OTC DRUG bareMinerals Complexion Rescue Broad Spectrum SPF 30 Spice 08 Titanium Dioxide LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 62 mg/mL N 20181231 98132-759_1e44dea4-0e5b-497c-beca-586d1ccb8426 98132-759 HUMAN OTC DRUG bareMinerals Complexion Rescue Broad Spectrum SPF 30 Chestnut 09 Titanium Dioxide LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 62 mg/mL N 20181231 98132-760_1e44dea4-0e5b-497c-beca-586d1ccb8426 98132-760 HUMAN OTC DRUG bareMinerals Complexion Rescue Broad Spectrum SPF 30 Sienna 10 Titanium Dioxide LIQUID TOPICAL 20150101 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 62 mg/mL N 20181231 98132-761_69c311bf-3ae9-486e-b6ef-4000ec1260fc 98132-761 HUMAN OTC DRUG bareMinerals Prep Step Mineral Shield Broad Spectrum SPF 50 Daily Prep Zinc Oxide and Titanium Dioxide LOTION TOPICAL 20150401 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. ZINC OXIDE; TITANIUM DIOXIDE 238; 41 mg/mL; mg/mL N 20181231 98132-762_006572f0-a98e-485c-86c8-9762ab91a22d 98132-762 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Silky Negli-Beige Octinoxate and Titanium Dioxide LIQUID TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL N 20181231 98132-763_006572f0-a98e-485c-86c8-9762ab91a22d 98132-763 HUMAN OTC DRUG Buxom Show Some Skin Weightless Foundation Broad Spectrum SPF 30 Tickle The Ivory Octinoxate and Titanium Dioxide LIQUID TOPICAL 20150601 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. OCTINOXATE; TITANIUM DIOXIDE 74; 61 mg/mL; mg/mL N 20181231 98132-770_54c77e38-f7c0-4ee9-aa59-a564cea2dd29 98132-770 HUMAN OTC DRUG bareMinerals Blemish Remedy Acne Treatment Gelee Cleanser SALICYLIC ACID EMULSION TOPICAL 20160130 OTC MONOGRAPH FINAL part333D Bare Escentuals Beauty, Inc. SALICYLIC ACID 10 mg/g N 20181231 98132-771_58e6e50d-b28a-4fca-8a42-4c8f82fbb9c3 98132-771 HUMAN OTC DRUG bareMinerals Blemish Remedy Acne Clearing Treatment Serum SALICYLIC ACID EMULSION TOPICAL 20170101 OTC MONOGRAPH FINAL part333D Bare Escentuals Beauty, Inc. SALICYLIC ACID 20 mg/mL N 20181231 98132-870_3d4a19fe-fbe5-455a-82f6-c40666ae7b37 98132-870 HUMAN OTC DRUG Medium Tan Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20101021 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 22; 6 g/100g; g/100g E 20171231 98132-871_9868751e-eb22-4e5d-9475-014cefd78a54 98132-871 HUMAN OTC DRUG Fair Foundation SPF 15 Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20101016 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 19; 25 g/100g; g/100g E 20171231 98132-872_2d9bce93-3f3d-4795-ba1b-27bbf735b228 98132-872 HUMAN OTC DRUG Fairly Light Foundation SPF 15 Titanium Dioxide POWDER TOPICAL 20101006 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-873_eeefcd92-db23-4f7f-8605-4b7b2b70580e 98132-873 HUMAN OTC DRUG Light Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20101002 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 18; 16 g/100g; g/100g E 20171231 98132-876_3713ec88-b55b-4951-b52d-45bdc9efc2b0 98132-876 HUMAN OTC DRUG Bisque Foundation SPF 20 Titanium Dioxide POWDER TOPICAL 20120525 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 24 g/100g N 20181231 98132-877_eeefcd92-db23-4f7f-8605-4b7b2b70580e 98132-877 HUMAN OTC DRUG Light Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 18; 16 g/100g; g/100g N 20181231 98132-879_9868751e-eb22-4e5d-9475-014cefd78a54 98132-879 HUMAN OTC DRUG Fair Foundation SPF 15 Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 19; 25 g/100g; g/100g N 20181231 98132-880_179c1df2-9660-4c0d-b9a5-4128d08d2260 98132-880 HUMAN OTC DRUG Medium Foundation SPF 15 Titanium Dioxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-881_467bc3ea-a9bd-475a-8f9a-a958a1ce6638 98132-881 HUMAN OTC DRUG Medium Beige Foundation SPF 15 Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20120114 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 21; 12 g/100g; g/100g N 20181231 98132-882_3d4a19fe-fbe5-455a-82f6-c40666ae7b37 98132-882 HUMAN OTC DRUG Medium Tan Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 22; 6 g/100g; g/100g N 20181231 98132-883_5a5251e4-13f1-466a-8966-fcd37664318f 98132-883 HUMAN OTC DRUG Tan Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 20; 7 g/100g; g/100g N 20181231 98132-884_e1270697-fded-43ab-b53d-07b67b14d05a 98132-884 HUMAN OTC DRUG Warm Tan Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 20; 7 g/100g; g/100g N 20181231 98132-885_5190d2ac-334d-4720-a452-d4f2ec089d96 98132-885 HUMAN OTC DRUG Golden Deep Foundation SPF 15 Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 20; 7 g/100g; g/100g N 20181231 98132-887_015dd32a-11cc-433c-8b97-f636e956782b 98132-887 HUMAN OTC DRUG Deepest Deep Zinc Oxide POWDER TOPICAL 20100113 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE 18 g/100g N 20181231 98132-888_50a12509-b6de-4abd-a1aa-8aff0b4ebf21 98132-888 HUMAN OTC DRUG Medium Deep Foundation SPF 15 Zinc Oxide, Titanium Dioxide POWDER TOPICAL 20120730 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 20; 7 g/100g; g/100g N 20181231 98132-889_3ee69419-86c7-4177-886e-bafc40ea4cfe 98132-889 HUMAN OTC DRUG Medium Dark Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 20; 7 g/100g; g/100g N 20181231 98132-890_3b6f890b-9ec7-4fa2-a3f8-1d24233cd35d 98132-890 HUMAN OTC DRUG Golden Dark Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 20; 7 g/100g; g/100g N 20181231 98132-891_39b9a8d9-05db-41d9-b8fd-60a714d1aa18 98132-891 HUMAN OTC DRUG Golden Medium Foundation SPF 15 Titanium Dioxide POWDER TOPICAL 20120116 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-893_d1d7af80-6692-4807-b904-acf8e1a5fa06 98132-893 HUMAN OTC DRUG Dark Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120516 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 20; 7 g/100g; g/100g N 20181231 98132-894_534396a4-2c0e-4784-b706-fe97661221a4 98132-894 HUMAN OTC DRUG bareMinerals Original Foundation Broad Spectrum SPF 15 Fair Ivory Titanium Dioxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-895_534396a4-2c0e-4784-b706-fe97661221a4 98132-895 HUMAN OTC DRUG bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Beige Titanium Dioxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-896_534396a4-2c0e-4784-b706-fe97661221a4 98132-896 HUMAN OTC DRUG bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Ivory Titanium Dioxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-897_534396a4-2c0e-4784-b706-fe97661221a4 98132-897 HUMAN OTC DRUG bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Nude Titanium Dioxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-898_534396a4-2c0e-4784-b706-fe97661221a4 98132-898 HUMAN OTC DRUG bareMinerals Original Foundation Broad Spectrum SPF 15 Light Beige Titanium Dioxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-899_534396a4-2c0e-4784-b706-fe97661221a4 98132-899 HUMAN OTC DRUG bareMinerals Original Foundation Broad Spectrum SPF 15 Neutral Ivory Titanium Dioxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-900_534396a4-2c0e-4784-b706-fe97661221a4 98132-900 HUMAN OTC DRUG bareMinerals Original Foundation Broad Spectrum SPF 15 Neutral Medium Titanium Dioxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-901_534396a4-2c0e-4784-b706-fe97661221a4 98132-901 HUMAN OTC DRUG bareMinerals Original Foundation Broad Spectrum SPF 15 Neutral Tan Titanium Dioxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-902_5a9b2d8b-9eff-4367-8a75-1e61ab27f9e7 98132-902 HUMAN OTC DRUG Honey Bisque Foundation SPF 20 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120521 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 20; 20 g/100g; g/100g N 20181231 98132-903_44fec199-21ac-44f0-a0d6-9130cb48ad31 98132-903 HUMAN OTC DRUG Summer Bisque Foundation SPF 20 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20120212 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 20; 20 g/100g; g/100g N 20181231 98132-904_ea41fc02-08ed-47b9-953c-da23330ec2f8 98132-904 HUMAN OTC DRUG BareMinerals Multi-Tasking SPF 20 Concealer Dark Bisque Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20100901 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 20; 20 g/100g; g/100g N 20181231 98132-905_534396a4-2c0e-4784-b706-fe97661221a4 98132-905 HUMAN OTC DRUG bareMinerals Original Foundation Broad Spectrum SPF 15 Soft Medium Titanium Dioxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-906_534396a4-2c0e-4784-b706-fe97661221a4 98132-906 HUMAN OTC DRUG bareMinerals Original Foundation Broad Spectrum SPF 15 Tan Nude Titanium Dioxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. TITANIUM DIOXIDE 25 g/100g N 20181231 98132-907_13cc1368-9eae-4b76-86e2-2c95ebf492a9 98132-907 HUMAN OTC DRUG bareMinerals Original Foundation Broad Spectrum SPF 15 Neutral Dark Zinc Oxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. ZINC OXIDE 20 g/100g N 20181231 98132-908_13cc1368-9eae-4b76-86e2-2c95ebf492a9 98132-908 HUMAN OTC DRUG bareMinerals Original Foundation Broad Spectrum SPF 15 Neutral Deep Zinc Oxide POWDER TOPICAL 20170201 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty, Inc. ZINC OXIDE 20 g/100g N 20181231 98132-920_ca213e30-9b91-4ec2-8b4d-7304545affe8 98132-920 HUMAN OTC DRUG Deep Bisque Foundation SPF 20 Titanium Dioxide, Zinc oxide POWDER TOPICAL 20120212 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 10; 16 g/100g; g/100g N 20181231 98132-923_810dc98b-c256-4f0c-8a33-ec41137e20e6 98132-923 HUMAN OTC DRUG Golden Fair Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20121115 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. TITANIUM DIOXIDE; ZINC OXIDE 25; 7.2 g/100g; g/100g N 20181231 98132-924_822c0ccb-3a77-436d-88c6-dacc56749a95 98132-924 HUMAN OTC DRUG Fairly Medium Foundation SPF 15 Titanium Dioxide, Zinc Oxide POWDER TOPICAL 20121112 OTC MONOGRAPH NOT FINAL part352 Bare Escentuals Beauty Inc. ZINC OXIDE; TITANIUM DIOXIDE 9.3; 25 g/100g; g/100g N 20181231 99207-010_fcdcfd7b-dda4-463b-9501-f1633ff51234 99207-010 HUMAN PRESCRIPTION DRUG Loprox ciclopirox SHAMPOO TOPICAL 20030320 NDA NDA021159 Valeant Pharmaceuticals North America LLC CICLOPIROX 10 mg/.96mL Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA] N 20181231 99207-130_c08e30fc-ad8b-4bc0-ab9f-644021a906bb 99207-130 HUMAN PRESCRIPTION DRUG MetroGel-Vaginal metronidazole GEL VAGINAL 20111128 NDA NDA020208 Medicis Pharmaceutical Corp METRONIDAZOLE 7.5 mg/g Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [Chemical/Ingredient] N 20181231 99207-170_45b425d1-bf6c-4d41-9df1-2f3a9dce78e4 99207-170 HUMAN PRESCRIPTION DRUG Minitran NITROGLYCERIN PATCH TRANSDERMAL 20120221 ANDA ANDA089771 Valeant Pharmaceuticals North America LLC NITROGLYCERIN 9 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 99207-171_45b425d1-bf6c-4d41-9df1-2f3a9dce78e4 99207-171 HUMAN PRESCRIPTION DRUG Minitran NITROGLYCERIN PATCH TRANSDERMAL 20120221 ANDA ANDA089772 Valeant Pharmaceuticals North America LLC NITROGLYCERIN 18 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 99207-172_45b425d1-bf6c-4d41-9df1-2f3a9dce78e4 99207-172 HUMAN PRESCRIPTION DRUG Minitran NITROGLYCERIN PATCH TRANSDERMAL 20120221 ANDA ANDA089773 Valeant Pharmaceuticals North America LLC NITROGLYCERIN 36 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 99207-173_45b425d1-bf6c-4d41-9df1-2f3a9dce78e4 99207-173 HUMAN PRESCRIPTION DRUG Minitran NITROGLYCERIN PATCH TRANSDERMAL 20120221 ANDA ANDA089774 Valeant Pharmaceuticals North America LLC NITROGLYCERIN 54 mg/1 Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] N 20181231 99207-240_143830d7-46a5-49a3-b8b2-457a59533008 99207-240 HUMAN PRESCRIPTION DRUG Calcium Disodium Versenate EDETATE CALCIUM DISODIUM INJECTION INTRAMUSCULAR; INTRAVENOUS 20130621 NDA NDA008922 Medicis Pharmaceutical Corp EDETATE CALCIUM DISODIUM 200 mg/mL Lead Chelating Activity [MoA],Lead Chelator [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA] N 20181231 99207-260_08d66993-cb6e-4844-ba9c-26bf1c866292 99207-260 HUMAN PRESCRIPTION DRUG Aldara imiquimod CREAM TOPICAL 19970227 NDA NDA020723 Valeant Pharmaceuticals North America LLC IMIQUIMOD 50 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] N 20181231 99207-270_4beb3609-c0fd-47df-a61c-329b896603ac 99207-270 HUMAN PRESCRIPTION DRUG Zyclara imiquimod CREAM TOPICAL 20111128 NDA NDA022483 Valeant Pharmaceuticals North America LLC IMIQUIMOD 37.5 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] N 20181231 99207-271_4beb3609-c0fd-47df-a61c-329b896603ac 99207-271 HUMAN PRESCRIPTION DRUG Zyclara imiquimod CREAM TOPICAL 20120101 NDA NDA022483 Valeant Pharmaceuticals North America LLC IMIQUIMOD 37.5 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] N 20181231 99207-276_4beb3609-c0fd-47df-a61c-329b896603ac 99207-276 HUMAN PRESCRIPTION DRUG Zyclara imiquimod CREAM TOPICAL 20120229 NDA NDA022483 Valeant Pharmaceuticals North America LLC IMIQUIMOD 2.5 mg/g Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA] N 20181231 99207-290_3b1df201-0ddf-4de8-8e75-ebbc9eea0331 99207-290 HUMAN OTC DRUG Esoterica Nighttime with Moisturizers hydroquinone CREAM TOPICAL 20050601 OTC MONOGRAPH NOT FINAL part358A Medicis Pharmaceutical Corp HYDROQUINONE 20 mg/g N 20181231 99207-291_922de4ce-7b60-418b-8b71-ddd2f6c311f3 99207-291 HUMAN OTC DRUG Esoterica Daytime with Moisturizers and Sunscreen hydroquinone, oxybenzone, and padimate o CREAM TOPICAL 20050601 OTC MONOGRAPH NOT FINAL part358A Medicis Pharmaceutical Corp HYDROQUINONE; OXYBENZONE; PADIMATE O 20; 25; 33 mg/g; mg/g; mg/g N 20181231 99207-292_7be41565-1714-46da-bb4c-2ba6957780d4 99207-292 HUMAN OTC DRUG Esoterica Daytime with Sunscreen hydroquinone, oxybenzone, and padimate o CREAM TOPICAL 20050601 OTC MONOGRAPH NOT FINAL part358A Medicis Pharmaceutical Corp HYDROQUINONE; OXYBENZONE; PADIMATE O 20; 25; 33 mg/g; mg/g; mg/g N 20181231 99207-300_1fe1b44e-1022-4b36-940f-44e4194e2099 99207-300 HUMAN PRESCRIPTION DRUG ZIANA clindamycin phosphate and tretinoin GEL TOPICAL 20061201 NDA NDA050802 Medicis Pharmaceutical Corp CLINDAMYCIN PHOSPHATE; TRETINOIN 12; .25 mg/g; mg/g Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [Chemical/Ingredient],Retinoid [EPC],Retinoids [Chemical/Ingredient] N 20181231 99207-463_a4dff85d-1a3c-4019-b659-03ba5b7def42 99207-463 HUMAN PRESCRIPTION DRUG Solodyn minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090723 NDA NDA050808 Valeant Pharmaceuticals North America LLC MINOCYCLINE HYDROCHLORIDE 65 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 99207-464_a4dff85d-1a3c-4019-b659-03ba5b7def42 99207-464 HUMAN PRESCRIPTION DRUG Solodyn minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20090723 NDA NDA050808 Valeant Pharmaceuticals North America LLC MINOCYCLINE HYDROCHLORIDE 115 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 99207-465_a4dff85d-1a3c-4019-b659-03ba5b7def42 99207-465 HUMAN PRESCRIPTION DRUG Solodyn minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100927 NDA NDA050808 Valeant Pharmaceuticals North America LLC MINOCYCLINE HYDROCHLORIDE 55 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 99207-466_a4dff85d-1a3c-4019-b659-03ba5b7def42 99207-466 HUMAN PRESCRIPTION DRUG Solodyn minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100927 NDA NDA050808 Valeant Pharmaceuticals North America LLC MINOCYCLINE HYDROCHLORIDE 80 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 99207-467_a4dff85d-1a3c-4019-b659-03ba5b7def42 99207-467 HUMAN PRESCRIPTION DRUG Solodyn minocycline hydrochloride TABLET, FILM COATED, EXTENDED RELEASE ORAL 20100927 NDA NDA050808 Valeant Pharmaceuticals North America LLC MINOCYCLINE HYDROCHLORIDE 105 mg/1 Tetracycline-class Drug [EPC],Tetracyclines [Chemical/Ingredient] N 20181231 99207-525_d47eda34-3952-463c-9597-4225a19dbf13 99207-525 HUMAN PRESCRIPTION DRUG Vanos fluocinonide CREAM TOPICAL 20060313 NDA NDA021758 Valeant Pharmaceuticals North America LLC FLUOCINONIDE 1 mg/g Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] N 20181231 99207-850_4fa7e444-9f5d-4174-b9d6-853fa6b0d860 99207-850 HUMAN PRESCRIPTION DRUG Luzu LULICONAZOLE CREAM TOPICAL 20131114 NDA NDA204153 Valeant Pharmaceuticals North America LLC LULICONAZOLE 10 mg/g Azole Antifungal [EPC],Azoles [Chemical/Ingredient],Cytochrome P450 2C19 Inhibitors [MoA] N 20181231 99528-3590_b7bd09a7-0c7a-44f1-b14e-fc823dcd813f 99528-3590 HUMAN OTC DRUG Kool Comfort Pain Relieving Roll-On Menthol LOTION TOPICAL 20090101 OTC MONOGRAPH NOT FINAL part348 Wonder Laboratories MENTHOL 3.5 g/100g N 20181231